Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2018 | Apr. 24, 2018 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q1 | |
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 | 140,025,397 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 26,706 | $ 43,946 |
Restricted cash | 527 | 4,409 |
Accounts receivable, net | 1,550 | 2,789 |
Inventory | 3,891 | 2,657 |
Deferred costs from commercial product sales | 405 | |
Prepaid expenses and other current assets | 2,354 | 3,010 |
Total current assets | 35,028 | 57,216 |
Property and equipment, net | 26,481 | 26,922 |
Other assets | 368 | 437 |
Total assets | 61,877 | 84,575 |
Current liabilities: | ||
Accounts payable | 4,976 | 6,984 |
Accrued expenses and other current liabilities | 15,930 | 12,449 |
Facility financing obligation | 43,654 | 52,745 |
Deferred revenue, net | 3,038 | |
Deferred payments from collaboration - current | 250 | 250 |
Recognized loss on purchase commitments - current | 15,859 | 12,131 |
Total current liabilities | 80,669 | 87,597 |
Note payable to related party | 72,247 | 79,666 |
Accrued interest - note payable to related party | 3,469 | 2,347 |
Senior convertible notes | 24,368 | 24,411 |
Recognized loss on purchase commitments - long term | 96,694 | 97,585 |
Deferred payments from collaboration - long term | 437 | 500 |
Milestone rights liability | 7,201 | 7,201 |
Total liabilities | 285,085 | 299,307 |
Commitments and contingencies (Note 12) | ||
Stockholders' deficit: | ||
Undesignated preferred stock, $0.01 par value - 10,000,000 shares authorized; no shares issued or outstanding at March 31, 2018 and December 31, 2017 | ||
Common stock, $0.01 par value - 280,000,000 shares authorized, 126,013,051 and 119,053,414 shares issued and outstanding at March 31, 2018 and December 31, 2017, respectively | 1,260 | 1,192 |
Additional paid-in capital | 2,658,957 | 2,638,992 |
Accumulated other comprehensive loss | (15) | (18) |
Accumulated deficit | (2,883,410) | (2,854,898) |
Total stockholders' deficit | (223,208) | (214,732) |
Total liabilities and stockholders' deficit | $ 61,877 | $ 84,575 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2018 | Dec. 31, 2017 |
Statement Of Financial Position [Abstract] | ||
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 | 280,000,000 | 280,000,000 |
Common stock, shares issued | 126,013,051 | 119,053,414 |
Common stock, shares outstanding | 126,013,051 | 119,053,414 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Revenues: | ||
Net revenue - commercial product sales | $ 3,402 | $ 1,196 |
Net revenue - collaboration | 63 | 63 |
Revenue - other | 1,750 | |
Total revenues | 3,465 | 3,009 |
Expenses: | ||
Cost of goods sold | 4,008 | 2,548 |
Research and development | 2,644 | 3,129 |
Selling, general and administrative | 20,618 | 15,389 |
Loss on foreign currency translation | 2,984 | 1,545 |
Total expenses | 30,254 | 22,611 |
Loss from operations | (26,789) | (19,602) |
Other (expense) income: | ||
Change in fair value of warrant liability | 6,629 | |
Interest income | 106 | 55 |
Interest expense on notes | (1,794) | (2,706) |
Interest expense on note payable to related party | (1,114) | (714) |
Loss on extinguishment of debt | (825) | |
Other income (expense) | 31 | 14 |
Total other (expense) income | (3,596) | 3,278 |
Loss before provision for income taxes | (30,385) | (16,324) |
Provision for income taxes | 0 | 0 |
Net loss | $ (30,385) | $ (16,324) |
Net loss per share - basic and diluted | $ (0.25) | $ (0.17) |
Shares used to compute basic and diluted net loss per share | 120,911 | 95,744 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Statement Of Income And Comprehensive Income [Abstract] | ||
Net loss | $ (30,385) | $ (16,324) |
Other comprehensive income (loss): | ||
Cumulative translation gain | 3 | |
Comprehensive loss | $ (30,382) | $ (16,324) |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (30,385) | $ (16,324) |
Adjustments to reconcile net loss to net cash (used in) provided by operating activities: | ||
Depreciation, amortization and accretion | 706 | 908 |
Stock-based compensation expense | 1,943 | 1,267 |
Loss on extinguishment of debt | 825 | |
Loss on foreign currency translation | 2,984 | 1,545 |
Interest on note payable to related party | 1,122 | 714 |
Change in fair value of warrant liability | (6,629) | |
Write-off of inventory | 602 | |
Other, net | 110 | |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | 1,128 | (136) |
Receivable from Sanofi | 30,557 | |
Inventory | (1,836) | (1,367) |
Deferred costs from commercial product sales | (163) | |
Prepaid expenses and other current assets | 656 | 856 |
Other assets | 38 | 39 |
Accounts payable | (2,008) | (1,665) |
Accrued expenses and other current liabilities | 2,675 | 1,077 |
Deferred revenue | (1,575) | |
Deferred payments from collaboration | (63) | (63) |
Recognized loss on purchase commitments | (147) | (534) |
Net cash (used in) provided by operating activities | (21,650) | 8,507 |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Net proceeds from sale of asset held for sale | 16,651 | |
Net cash provided by investing activities | 16,651 | |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Payment of employment taxes related to vested restricted stock units | (81) | (75) |
Proceeds from issuance of common stock pursuant to at-the-market issuance | 634 | |
Issuance cost of at-the-market transactions | (25) | |
Net cash provided by (used in) financing activities | 528 | (75) |
NET (DECREASE) INCREASE IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | (21,122) | 25,083 |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH, BEGINNING OF PERIOD | 48,355 | 22,895 |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH, END OF PERIOD | 27,233 | 47,978 |
SUPPLEMENTAL CASH FLOWS DISCLOSURES: | ||
Interest paid in cash, net of amounts capitalized | 1,860 | $ 2,550 |
NON-CASH INVESTING AND FINANCING ACTIVITIES: | ||
Payment of note obligations through common stock issuance | 9,407 | |
Payment of note payable to related party through common stock issuance | 8,160 | |
Accrued but unpaid debt issuance costs related to note payable to related party | $ 75 |
Description of Business and Sig
Description of Business and Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2018 | |
Accounting Policies [Abstract] | |
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, 2017 filed with the SEC on February 27, 2018 (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 months ended March 31, 2018 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 and gross-to-net adjustments, assessing long-lived assets for impairment, clinical trial expenses, inventory costing and recoverability, recognized loss on purchase commitments, milestone rights liability, stock-based compensation and the determination of the provision for income taxes and corresponding deferred tax assets and liabilities and the valuation allowance recorded against net deferred tax assets. Business — MannKind is a biopharmaceutical company focused on the development and commercialization of inhaled therapeutic products for diseases such as diabetes and pulmonary arterial hypertension. The Company’s only approved product, Afrezza (insulin human) Inhalation Powder, is a rapid-acting inhaled insulin that was approved by the U.S. Food and Drug Administration (the “FDA”) in June of 2014 to improve glycemic control in adults with diabetes. Afrezza became available by prescription in U.S. retail pharmacies in February 2015. Pursuant to a license and collaboration agreement (the “Sanofi License Agreement”) between the Company and Sanofi-Aventis U.S. LLC (“Sanofi”), Sanofi was responsible for global commercial, regulatory and development activities associated with Afrezza from August 2014 to April 2016, after which these responsibilities transitioned back the Company. Currently, the Company promotes Afrezza to endocrinologists and certain high-prescribing primary care physicians in the United States through its own specialty sales force. Outside of the United States, subject to receipt of the necessary foreign regulatory approvals, the Company is seeking to establish regional partnerships for the commercialization of Afrezza in foreign jurisdictions where there are commercial opportunities. Basis of Presentation - The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company is not currently profitable and has rarely generated positive net cash flow from operations. As of March 31, 2018, the Company had an accumulated deficit of $2.9 billion. At March 31, 2018, the Company’s capital resources consisted of cash and cash equivalents of $26.7 million. The Company expects to continue to incur significant expenditures to support commercial manufacturing, 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 7 — Borrowings) requires the Company to maintain at least $25.0 million in cash and cash equivalents or certain available borrowings (which are no longer available) as of the last day of each fiscal quarter. As of March 31, 2018, the Company has $140.2 million principal amount of outstanding borrowings. The Company has entered into certain transactions related to these borrowings during 2017 and 2018 that are more fully described in Note 6 — Related-Party Arrangements, and Note 7 – Borrowings. The Company’s current available cash and financing sources will not be sufficient to meet its current and anticipated cash requirements. The Company plans 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. Successful completion of these plans is dependent on factors outside of the Company’s control. As such, management cannot be certain that such plans will be effectively implemented within one year after the date that the financial statements are issued. 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. Reverse Stock-Split - On March 1, 2017, following stockholder approval, the Company’s board of directors approved a 1-for-5 reverse stock split of its outstanding common stock. 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, prior to March 3, 2017, 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. Principles of Consolidation – The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. Intercompany balances and transactions have been eliminated. Segment Information – Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. To date, the Company has viewed its operations and manages its business as one segment operating in the United States of America. Revenue Recognition — The Company adopted Accounting Standards Codification (“ASC”) Topic 606 - Revenue from Contracts with Customers (“the new revenue guidance”), on January 1, 2018. Under Topic 606, the Company recognizes revenue when its customers obtain control of promised goods or services, in an amount that reflects the consideration which the Company expects to be entitled in exchange for those goods or services. See below for more information about the impact of adoption of the new revenue guidance. To determine revenue recognition for arrangements that are within the scope of Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract under Topic 606, including when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company has three types of contracts with customers: contracts with wholesale distributors and specialty pharmacies for commercial product sales, collaboration arrangements, and arrangements with parties to whom it has sold intellectual property. Revenue Recognition – Net Revenue – Commercial Product Sales – The Company sells Afrezza to a limited number of wholesale distributors and specialty pharmacies in the U.S. (collectively, its “Customers”). These Customers subsequently resell the Company’s products to retail pharmacies and certain medical centers or hospitals. Specialty pharmacies sell directly to patients. In addition to distribution agreements with Customers, the Company enters into arrangements with health care providers and payors that provide for government mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. The Company recognizes revenue on product sales when the Customer obtains control of the Company's product, which occurs at a point in time (based on the terms of the relevant contracts which are at delivery for wholesale distributors and at shipment for specialty pharmacies). Product revenues are recorded net of applicable reserves for variable consideration, including discounts and allowances. Voucher Program – Under the voucher program, potential new patients are given vouchers which they can provide to retailers for a free product. The retailers provide the product to the patient for free and pay the wholesaler for the product, who pays the Company. The retailers submit the vouchers to a program administrator which pays the retailer for the product. The administrator then invoices the Company for the amount of vouchers paid plus a fee. Accordingly, on a net basis, it is not probable that the Company will receive the consideration to which it is entitled for these products. Therefore, the Company excludes such amounts from both gross and net revenue. The cost of product associated with the voucher program is included in cost of goods sold. Reserves for Variable Consideration — Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payor rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its Customers, payors, and other indirect customers relating to the Company’s sale of its products. These reserves, as detailed below, are based on the amounts earned, or to be claimed on the related sales, and result in a reduction of accounts receivable or establishment of a current liability. Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted in accordance with the expected value method in Topic 606 for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reduce recognized revenue to the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts. The amount of variable consideration which is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. The Company’s analyses also contemplates application of the constraint in accordance with the guidance, under which it determined a material reversal of revenue would not occur in a future period for the estimates detailed below as of March 31, 2018 and, therefore, the transaction price was not reduced further during the three months ended March 31, 2018. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net revenue – commercial product sales and earnings in the period such variances become known. Trade Discounts and Allowances — The Company generally provides Customers with discounts which include incentive fees, such as prompt pay discounts, that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, the Company compensates (through trade discounts and allowances) its Customers for sales order management, data, and distribution services. However, the Company has determined such services received to date are not distinct from the Company’s sale of products to the Customer and, therefore, these payments have been recorded as a reduction of revenue and a reduction to accounts receivable, net. Product Returns — Consistent with industry practice, the Company generally offers Customers a right of return for unopened product that has been purchased from the Company for a period beginning six months prior to and ending twelve months after its expiration date , which lapses upon shipment to a patient. The Company estimates the amount of its product sales that may be returned by its Customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as reductions to accounts receivable, net. The Company currently estimates product returns using available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel. The Company currently estimates that 2.46% of products will be returned. Provider Chargebacks and Discounts — Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from the Company. Customers charge the Company for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is recorded in accrued expenses and other current liabilities. Chargeback amounts are generally determined at the time of resale to the qualified healthcare provider by Customers, and the Company generally issues credits for such amounts within a few weeks of the Customer’s notification to the Company of the resale. Reserves for chargebacks consist of credits that the Company expects to issue for units that remain in the distribution channel inventories at each reporting period-end that the Company expects will be sold to qualified healthcare providers, and chargebacks that Customers have claimed, but for which the Company has not yet issued a credit. Government Rebates — The Company is subject to discount obligations under state Medicaid programs and Medicare. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period. Payor Rebates — The Company contracts with certain private payor organizations, primarily insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of its products. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities. Other Incentives — Other incentives which the Company offers include voluntary patient support programs, such as the Company's co-pay assistance program, which are intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payors. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities. As of December 31, 2017, prior to the adoption of Topic 606, the ending balance for net deferred revenue, was $3.0 million, on the Company’s condensed consolidated balance sheets which is presented net of $1.5 million in gross-to-net revenue adjustments. On January 1, 2018, deferred revenue was adjusted to zero as a result of the adoption of Topic 606 as disclosed below. For the three months ended March 31, 2018 and 2017, shipments to three wholesale distributors represented 87% and 93% of total shipments, respectively. Revenue Recognition – Net Revenue – Collaborations — The Company enters into out-licensing agreements under which the Company licenses certain rights to its product candidates to third parties. The terms of these arrangements may include payment to the Company of one or more of the following: non-refundable, up-front license fees; development, regulatory, and commercial milestone payments; payments for manufacturing supply services the Company provides; and royalties on net sales of licensed products and sublicenses of the rights. Each of these payments may result in license, collaboration, or other revenue, except revenue from royalties on net sales of licensed products, which would be classified as royalty revenue. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. The Company uses key assumptions to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates, and probabilities of technical and regulatory success. Licenses of Intellectual Property — If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company will evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. Revenue from licenses of intellectual property is included in Net revenue - Collaboration in the condensed consolidated statement of operations. Milestone Payments — At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the customer, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as, or when, the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration, other revenue, and earnings in the period of adjustment. Manufacturing Supply Services — Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply, at the customer’s discretion, are generally considered as options. The Company assesses if these options provide a material right to the licensee and, if so, they are accounted for as separate performance obligations. If the Company is entitled to additional payments when the licensee exercises these options, any additional payments are recorded in license, collaboration, or other revenue when the customer obtains control of the goods, which is upon delivery. Royalties — For licensing arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all the royalty has been allocated has been satisfied (or partially satisfied). For sales of intellectual property that include sales-based royalties, the Company estimates the amount of variable consideration that it will receive from the sales-based royalty. The Company has not recognized any royalty revenue resulting from the sale of its intellectual property in 2017 which is more fully described in Note 9, Sale of Intellectual Property. Revenue Recognition — Revenue — Other — For the three months ended March 31, 2017, revenue-other consists of $1.7 million of revenue from bulk insulin sales. Cost of Goods Sold — A significant component of cost of goods sold is current period manufacturing costs in excess of costs capitalized into inventory (excess capacity costs). These costs, in addition to the impact of the annual revaluation of inventory to standard costs (and the annual revaluation of deferred costs of commercial sales to standard costs in 2017), and write-offs of inventory (and write-offs of deferred costs of commercial sales in 2017) are recorded as expenses in the period in which they are incurred, rather than as a portion of inventory costs. Cost of goods sold also includes the standard cost related to Afrezza sold during the period and related variances. Restricted Cash – The Company records restricted cash when cash and cash equivalents are restricted as to withdrawal or usage. The Company presents amounts of restricted cash that will be available for use within twelve months of the reporting date as restricted cash in current assets. Restricted cash amounts that will not be available for use in the Company’s operations within twelve months of the reporting date are presented as restricted cash in long term assets. Accounts Receivable and Allowance for Doubtful Accounts — Accounts receivable are recorded at the invoiced amount and are not interest bearing. Accounts receivable are presented net of an allowance for doubtful accounts if there are estimated losses resulting from the inability of its customers to make required payments. The Company makes ongoing assumptions relating to the collectability of its accounts receivable in its calculation of the allowance for doubtful accounts. Accounts receivable are also presented net of an allowance for product returns and trade discounts and allowances because the Company’s customers have the right of setoff for these amounts against the related accounts receivable. Inventories — Inventories are stated at the lower of cost or net realizable value. The Company determines the cost of inventory using the first-in, first-out, or FIFO, method. The Company capitalizes inventory costs associated with the Company’s products based on management’s judgment that future economic benefits are expected to be realized; otherwise, such costs are expensed as incurred as cost of goods sold. The Company periodically analyzes its inventory levels to identify inventory that may expire or has a cost basis in excess of its estimated realizable value and writes down such inventories, as appropriate. In addition, the Company’s products are subject to strict quality control and monitoring which the Company performs throughout the manufacturing process. If certain batches or units of product no longer meet quality specifications or may become obsolete or are forecasted to become obsolete due to expiration, the Company will record a charge to write down such unmarketable inventory to its estimated net realizable value. Leases – The Company records rent expense for leases that contain scheduled rent increases on a straight-line basis over the lease term which begins with the point at which the Company obtains control and possession of the leased property. Recognized Loss on Purchase Commitments — The Company assesses whether losses on long term purchase commitments should be accrued. Losses that are expected to arise from firm, non-cancellable, commitments for the future purchases are recognized unless recoverable. When making the assessment, the Company also considers whether it is able to renegotiate with its vendors. The recognized loss on purchase commitments is reduced as inventory items are received. If, subsequent to an accrual, a purchase commitment is successfully renegotiated, the gain is recognized in the Company’s condensed consolidated statement of operations. The liability balance of the recognized loss on insulin purchase commitments is $112.3 million as of March 31, 2018. No new contracts were identified in 2018 or 2017 that required a new loss on purchase commitment accrual. Fair Value of Financial Instruments — The Company applies various valuation approaches in determining the fair value of its financial assets and liabilities within a hierarchy that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. The fair value hierarchy is broken down into three levels based on the source of inputs as follows: Level 1 — Quoted prices for identical instruments in active markets. Level 2 — Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable. Level 3 — Significant inputs to the valuation model are unobservable. Contingencies — The Company records a loss contingency for a liability when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. These accruals represent management’s best estimate of probable loss. Disclosure also is provided when it is reasonably possible that a loss will be incurred or when it is reasonably possible that the amount of a loss will exceed the recorded provision. On a quarterly basis, the Company reviews the status of each significant matter and assesses its potential financial exposure. Significant judgment is required in both the determination of probability and the determination as to whether an exposure is reasonably estimable. Because of uncertainties related to these matters, accruals are based only on the best information available at the time. As additional information becomes available, the Company reassesses the potential liability related to pending claims and litigation and may revise its estimates. Stock-Based Compensation — Share-based payments to employees, including grants of stock options, restricted stock units, performance-based awards and the compensatory elements of employee stock purchase plans, are recognized in the condensed consolidated statements of operations based upon the fair value of the awards at the grant date subject to an estimated forfeiture rate. The Company uses the Black-Scholes option valuation model to estimate the grant date fair value of employee stock options and the compensatory elements of employee stock purchase plans. Restricted stock units are valued based on the market price on the grant date. The Company evaluates stock awards with performance conditions as to the probability that the performance conditions will be met and estimates the date at which the performance conditions will be met in order to properly recognize stock-based compensation expense over the requisite service period. Clinical Trial Expenses — Clinical trial expenses, which are primarily reflected in research and development expenses in the accompanying condensed consolidated statements of operations, result from obligations under contracts with vendors, consultants and clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to the Company under |
Accounts Receivable
Accounts Receivable | 3 Months Ended |
Mar. 31, 2018 | |
Receivables [Abstract] | |
Accounts Receivable | 2. Accounts Receivable Accounts receivable, net consists of the following (in thousands): March 31, 2018 December 31, 2017 Accounts receivable, gross $ 2,019 $ 2,842 Wholesaler distribution fees and prompt pay discounts (340 ) (53 ) Reserve for returns (129 ) — Accounts receivable, net $ 1,550 $ 2,789 As of December 31, 2017 the Company did not have a return reserve as the Company was on the sell-through method (as described in Note 1 – Description of Business and Significant Accounting Policies). As of March 31, 2018 and December 31, 2017, the allowance for doubtful accounts was de minimis |
Inventories
Inventories | 3 Months Ended |
Mar. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Inventories | 3. Inventories Inventories consist of the following (in thousands): March 31, 2018 December 31, 2017 Raw materials $ 772 $ 572 Work-in-process 2,519 1,273 Finished goods 600 812 Total inventory $ 3,891 $ 2,657 Work-in-process and finished goods as of March 31, 2018 and December 31, 2017 are substantially all conversion costs because the materials used in its production were previously written off. The Company analyzed its inventory levels to identify inventory that may expire or has a cost basis in excess of its estimated realizable value. The Company performed an assessment of projected sales and evaluated the lower of cost or net realizable value and the potential excess inventory on hand at March 31, 2018. For the three months ended March 31, 2018 the Company recorded a $0.6 million charge to write-off inventory that may expire prior to sale which was recorded as cost of goods sold. |
Property and Equipment
Property and Equipment | 3 Months Ended |
Mar. 31, 2018 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | 4. Property and Equipment Property and equipment consist of the following (in thousands): Estimated Useful Life (Years) March 31, 2018 December 31, 2017 Land — $ 875 $ 875 Buildings 39-40 17,389 17,389 Building improvements 5-40 34,957 34,957 Machinery and equipment 3-15 62,681 62,681 Furniture, fixtures and office equipment 5-10 3,106 3,556 Computer equipment and software 3 8,416 8,416 127,424 127,874 Less accumulated depreciation (100,943 ) (100,952 ) Total property and equipment, net $ 26,481 $ 26,922 Depreciation expense related to property and equipment for the three months ended March 31, 2018 and 2017 was as follows (in thousands): Three Months Ended March 31, 2018 2017 Depreciation Expense $ 441 $ 446 During the three months ended March 31, 2018, the Company disposed of $0.4 million of certain furniture, fixtures and office equipment which ceased being used. The items disposed were fully depreciated. Therefore, the cost and associated accumulated depreciation for these items was removed from the balance sheet. 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 | 3 Months Ended |
Mar. 31, 2018 | |
Payables And Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 5. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities are comprised of the following (in thousands): March 31, 2018 December 31, 2017 Salary and related expenses $ 10,474 $ 7,260 Current portion of milestone rights liability 1,643 1,643 Professional fees 872 1,007 Discounts and allowances for commercial product sales 766 873 Sales and marketing services 625 147 Restructuring 362 362 Accrued interest 226 567 Other 962 590 Accrued expenses and other current liabilities $ 15,930 $ 12,449 Accrued salary and related expenses includes $0.8 million in selling, general and administrative costs related to transitioning certain corporate support functions from Connecticut to the corporate headquarters in California. |
Related-Party Arrangements
Related-Party Arrangements | 3 Months Ended |
Mar. 31, 2018 | |
Related Party Transactions [Abstract] | |
Related-Party Arrangements | 6. Related Party Arrangements Related party debt consist of the following (in thousands): March 31, 2018 December 31, 2017 Principal amount $ 71,506 $ 79,666 Unamortized premium 815 — Unaccreted debt issuance costs (74 ) — Net carrying amount $ 72,247 $ 79,666 In October 2007, the Company entered into a loan arrangement (the “Mann Group Loan Arrangement”) with The Mann Group LLC (the “The Mann Group”), which has been amended from time to time. At that time, Alfred Mann, the Company’s then Chairman and Chief Executive Officer, was the managing member of The Mann Group LLC. On October 31, 2013, the promissory note underlying the Mann Group Loan Arrangement, described in the Company’s condensed consolidated balance sheets as Note Payable to Related Party, 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. On March 11, 2018, the Company amended and restated the Mann Group Loan Arrangement with The Mann Group to, among other things, (i) reflect the current outstanding principal balance of the existing loan of $71.5 million, after giving effect to the partial cancelation of principal in exchange for shares of the Company’s common stock described below; (ii) extend the maturity date of the loan to July 1, 2021; (iii) for periods beginning after April 1, 2018 require interest to compound quarterly; and (iv) permit the principal and any accrued and unpaid interest under the Mann Group Loan Arrangement to be converted, at the option of The Mann Group, at any time on or prior to close of business on the business day immediately preceding the stated maturity date, into shares of the Company’s common stock. The conversion rate of 250 shares per $1,000 principal amount of the Note, which is equal to $4.00 per share subject to adjustment under certain circumstances as described in the Mann Group Loan Arrangement. The Company analyzed this amendment and concluded that the transaction represented an extinguishment of the related party note and recorded a $0.8 million loss on extinguishment of debt. As a result of the extinguishment the Company recorded a debt premium of $0.8 million and debt issuance costs of $0.1 million for the three months ended March 31, 2018. On March 11, 2018, the Company and The Mann Group entered into a common stock purchase agreement pursuant to which the Company agreed to issue to The Mann Group and The Mann Group agreed to purchase 3,000,000 shares of the Company’s common stock at a price per share of $2.72 which represented the closing price of the Company’s common stock on March 9, 2018. As payment for the purchase price for the shares, The Mann Group agreed to cancel $8.2 million in principal amount under the Mann Group Loan Arrangement, with the principal payment to be reflected in the amended and restated Mann Group Loan Arrangement. The purchased shares were issued in a private placement. 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. Under the agreement, accrued and unpaid interest may be paid-in-kind. 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 $113.2 million aggregate principal amount that has been cancelled in connection with three 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 March 31, 2018 and December 31, 2017, the Company had accrued unpaid interest related to the above note of $3.5 million and $2.3 million, respectively. As of March 31, 2018 and December 31, 2017 there were no additional amounts available for future borrowings. Interest expense (excluding the amortization of debt premium and debt issuance costs) for the three months ended March 31, 2018 and 2017 was as follows (in thousands): Three Months Ended March 31, 2018 2017 Interest expense on note payable to related party $ 1,122 $ 714 Amortization of the premium and accretion of debt issuance costs related to the related party notes for the three months ended March 31, 2018 and 2017 are as follows (in thousands): Three Months Ended March 31, 2018 2017 Amortization of debt premium $ 10 $ — Accretion expense - debt issuance cost $ 2 $ — 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 was renewed on a month-to-month basis at a rate of $20,000 per month until August 31, 2017 at which time the Company moved into its new corporate headquarters in Westlake Village, California (see Note 12 — Commitments and Contingencies). Lease payments to the Mann Foundation for the three months ended March 31, 2017 were $62,000. 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 12 —Commitments and Contingencies). On October 10, 2017, the Company entered into securities purchase agreements (the “Purchase Agreements”) with certain institutional investors and a charitable foundation (collectively, the “Purchasers”). Included in this offering were 166,600 shares at a purchase price of $6.00 per share issued to the Kresa Family Foundation, of which Kent Kresa, the Company’s Chairman of the Board, is the President. |
Borrowings
Borrowings | 3 Months Ended |
Mar. 31, 2018 | |
Debt Disclosure [Abstract] | |
Borrowings | 7. Borrowings Borrowings consist of the following (in thousands): March 31, 2018 December 31, 2017 Facility Financing Obligation (2019 Notes and Tranche B Notes) Principal amount $ 45,000 $ 54,407 Unamortized debt issuance costs and debt discount (1,346 ) (1,662 ) Net carrying amount $ 43,654 $ 52,745 Senior Convertible Notes (2021 Notes) Principal amount $ 23,690 $ 23,690 Unamortized premium 678 721 Net carrying amount $ 24,368 $ 24,411 Note payable to related party - net carrying amount $ 72,247 $ 79,666 Total debt - net carrying amount $ 140,269 $ 156,822 In addition to the Mann Group Loan Arrangement described in Note 6, the Company has $23.7 million principal amount of 2021 notes bearing interest at 5.75% per annum and maturing on October 23, 2021, which are convertible and a convertible facility financing agreement which includes: • $35.0 million principal amount of 2019 notes bearing interest at 9.75% per annum. Interest is payable in cash quarterly in arrears in the last business day of March, June, September and December of each year. $15.0 million will become due and payable on each of July 2018 and July 2019, and $5.0 million will become due and payable in December 2019; and • $10.0 million principal amount of Tranche B notes bearing interest at 8.75% per annum. Interest is payable in cash quarterly in arrears on the last business day of March, June, September and December of each year. The principal amount is due and payable as follows: $5.0 million in May and December 2019. These borrowings are further described below: Facility Financing Obligation (2019 Notes and Tranche B Notes) – The Facility Financing Obligation was initially entered into in 2013 between the Company and Deerfield Private Design Fund II, L.P. and Deerfield Private Design International II, L.P. (collectively, “Deerfield”) through the issuance of multiple tranches of notes. As of December 31, 2017, there were $39.4 million principal amount of 2019 notes and $15.0 million principal amount of Tranche B notes outstanding. On April 18, 2017, the Company entered into an Exchange Agreement with Deerfield pursuant to which the Company agreed to, among other things, (i) repay $4.0 million principal amount under the Tranche B notes; (ii) exchange $1.0 million principal amount under the Tranche B notes for 869,565 shares of the Company’s common stock (the “Tranche B Exchange Shares”); and (iii) exchange $5.0 million principal amount under the 2019 notes for 4,347,826 shares of the Company’s common stock (together with the “Tranche B Exchange Shares,” the “April Exchange Shares”). The exchange price for the Exchange Shares was at a discount of $1.15 per share. The Company determined that, since the principal amount repaid and exchanged under the Tranche B notes and the principal amount exchanged under the 2019 notes represented 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 at April 18, 2017 which was calculated as the difference between the reacquisition price and the net carrying value of the related debt. 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, which represents the closing price of the Company’s common stock 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 Company’s 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, which was further deferred to October 31, 2017 upon the Company’s delivery on August 31, 2017 and October 30, 2017 of a written certification to Deerfield that certain conditions had been met, including that no event of default under the Facility Agreement had occurred, Michael E. Castagna remains the Company’s Chief Executive Officer, the Company received the advance from The Mann Group (see Note 6 — Related-Party Arrangements), the Company had at least $10.0 million in cash and cash equivalents on hand, no material adverse effect on the Company had occurred, the engagement letter between the Company and Greenhill & Co., Inc. (“Greenhill”) remained in full force and effect and Greenhill had 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 $25.0 million in cash and cash equivalents as of the end of each quarter was reduced to $10.0 million as of August 31, 2017, September 30, 2017, October 31, 2017 and December 31, 2017 if certain conditions were met. We met the conditions at each of these month-ends. The Company determined that the principal amount repaid and exchanged under the 2019 notes represented the principal amount that would have otherwise become due and payable under the 2019 notes. As a result, 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 on June 29, 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 which represented the closing price of the Company’s common stock on June 29, 2017. On October 23, 2017, the Company entered into a Fourth Amendment to the Facility Agreement, pursuant to which the parties (i) deferred the payment of $10.0 million in principal amount (the “October Payment”) of the Facility Financing Obligation from October 31, 2017 to January 15, 2018, with the Company depositing an amount of cash equal to the October Payment into an escrow account until the October Payment has been satisfied in full (subject to early release to the extent that portions of the October Payment are satisfied through the exchange of principal for shares of the Company’s common stock), and (ii) amended and restated the Facility Financing Obligation and the Tranche B notes to provide that Deerfield may convert the principal amount under such notes from time to time into an aggregate of up to 4,000,000 shares of the Company’s common stock after the effective date of the Fourth Amendment. The conversion price will be the greater of (i) the average of the volume weighted average price per share of the Company’s common stock for the three trading day period immediately preceding the date of any election by Deerfield to convert principal amounts of such notes and (ii) $3.25 per share, subject to adjustment under certain circumstances. Any conversions of principal by Deerfield under such notes will be applied first to reduce the October Payment, and after the October Payment has been satisfied, to reduce other principal payments due. The Company determined that the Fourth Amendment did not include any concessions and that the addition of the conversion option was not substantive and therefore it was not considered to be a troubled debt restructuring. Accordingly, the Company accounted for the transaction as a modification. On November 6, 2017 Deerfield converted 1,720,846 shares under the conversion feature at a price of $3.25 per share, redeeming $5.6 million of principal amount. On January 15, 2018, the Company entered into a Fifth Amendment (the “Fifth Deerfield Amendment”) with Deerfield to the Facility Agreement, pursuant to which the parties deferred the payment date for the $4.4 million remaining October 2017 Tranche 4 Principal Payment from January 15, 2018 to January 19, 2018. Concurrent with this amendment the Company entered into a First Amendment to Escrow Agreement to extend the escrow period to January 19, 2018 to align with the amended payment date under the Fifth Deerfield Amendment. On January 18, 2018, the Company entered into an Exchange and Sixth Amendment to Facility Agreement (the “Sixth Deerfield Amendment”) with Deerfield, pursuant to which, among other things, the Company agreed to issue to Deerfield an aggregate of 1,267,972 shares of its common stock, par value $0.01 per share (the “Exchange Shares”), in exchange for $3.2 million of the 2019 Notes, an exchange rate of $2.49 per share. In addition, the parties deferred the payment date for the $1.3 million remaining principal amount of the 2019 Notes (the “Remaining Payment”) from January 19, 2018 to May 6, 2018. The Company and Deerfield also amended the outstanding 2019 Notes and Tranche B notes to provide that Deerfield may, subject to the terms of the Sixth Deerfield Amendment, convert principal amounts of the 2019 notes and Tranche B notes from time to time into an aggregate of up to 10,000,000 shares of the Company’s common stock (excluding the Exchange Shares). The conversion price will be the greater of (i) the average of the volume weighted average price per share of the Company’s common stock for the three trading day period immediately preceding the date of any election by Deerfield to convert principal amounts and (ii) $2.75 per share, subject to adjustment under certain circumstances described in the 2019 notes and Tranche B notes. Any conversions of principal will be applied first to reduce the Remaining Payment, and thereafter to reduce other principal payments. In connection with the Sixth Deerfield Amendment, the Company also entered into a Second Amendment to Escrow Agreement, dated January 18, 2018, with Deerfield and US Bank, pursuant to which the parties extended the period of the escrow established thereunder to May 6, 2018, corresponding to the extended payment date. The Company determined that the Fifth and Sixth Amendments did not include any concessions and that the change of the conversion option was not substantive and therefore it was not considered to be a troubled debt restructuring. Accordingly, the Company accounted for the transaction as a modification. On March 6, 2018 Deerfield converted the remaining $1.3 million of principal amount due under the 2019 Notes for 441,618 shares of the Company’s common stock (the “January Exchange Shares”). The fair value of the January Exchange Shares was determined to be $2.83 per share representing the average of the volume weighted average price per share of the Company’s common stock for the three trading day period immediately preceding the date of the election by Deerfield to convert per the NASDAQ Global Market. The Escrow Agreement with Deerfield and US Bank, was terminated as the required payment was satisfied in full as of March 12, 2018. On March 12, 2018 the Company entered into an Exchange Agreement with Deerfield pursuant to which the Company agreed to, among other things, exchange $5.0 million of principal amount under the 8.75% Tranche B Notes for 1,838,236 shares of the Company’s common stock (the “March Exchange Shares”). The fair value of the March Exchange Shares was determined to be $2.72 per share representing the closing price of the Company’s common stock on March 9, 2018 per the NASDAQ Global Market. The principal amount being exchanged under the Tranche B Notes represents the principal amount that would have otherwise become due and payable in May 2018. 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”). During the first quarter of 2015, a milestone triggering event was achieved due to the launch of Afrezza. This resulted in a $5.8 million incremental charge to interest expense due to an increase in the carrying value of the liability to account for the $10.0 million milestone payment made in February 2015. As of March 31, 2018 and December 31, 2017, the remaining milestone rights liability balance was $8.9 million. The Company currently estimates that it will reach the next milestone in the first quarter of 2019. Accordingly, $1.6 million in value related to the next milestone payment was recorded in accrued expenses and other current liabilities as of March 31, 2018 and December 31, 2017, resulting in $7.2 million being recorded in milestone rights liability, which is non-current, in the accompanying condensed consolidated balance sheets as of March 31, 2018 and December 31, 2017, respectively. Accretion of debt issuance cost and debt discount during the three months ended March 31, 2018 and 2017, are as follows (in thousands): Three Months Ended March 31, 2018 2017 Accretion expense - debt issuance cost $ 6 $ 9 Accretion expense - debt discount $ 310 $ 447 The Facility Agreement includes customary representations, warranties and covenants, including a restriction on the incurrence of additional indebtedness. 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 Facility Financing Obligation has been classified as a current liability in the accompanying condensed consolidated balance sheets as of March 31, 2018 and December 31, 2017. In the event of non-compliance, Deerfield may declare all or any portion of the Facility Financing Obligation to be immediately due and payable. Milestone Rights — The Milestone Agreement includes customary representations and warranties and covenants by the Company, including restrictions on transfers of intellectual property related to Afrezza. The Milestone Rights are subject to acceleration in the event the Company transfers its intellectual property related to Afrezza in violation of the terms of the Milestone Agreement. The Company has initially recorded the Milestone Rights at their estimated fair value. Security Agreement — In connection with the Facility Agreement and Milestone Agreement, the Company and its subsidiary, MannKind LLC, entered into a Guaranty and Security Agreement (the “Security Agreement”) with Deerfield and Horizon Santé FLML SÁRL (collectively, the “Purchasers”), pursuant to which the Company and MannKind LLC each granted the Purchasers a security interest in substantially all of their respective assets, including respective intellectual property, accounts receivables, equipment, general intangibles, inventory and investment property, and all of the proceeds and products of the foregoing. The Security Agreement includes customary covenants by the Company and MannKind LLC, remedies of the Purchasers and representations and warranties by the Company and MannKind LLC. The security interests granted by the Company and MannKind LLC will terminate upon repayment of the Facility Financing Obligation, if applicable, in full. Embedded Derivatives — The Company identified and evaluated a number of embedded features in the notes issued under the Facility Agreement to determine if they represented embedded derivatives that are required to be separated from the notes and accounted for as freestanding instruments. The Company analyzed the Tranche B notes and identified embedded derivatives which required separate accounting. All of the embedded derivatives were determined to have a value as of March 31, 2018 and December 31, 2017. Senior Convertible Notes Due 2021 — On October 23, 2017, the Company entered into exchange agreements with the holders of the Company’s 5.75% Senior Convertible Notes due 2018 (the “2018 notes”), pursuant to which the Company agreed to exchange all of the outstanding 2018 notes in the aggregate principal amount of $27.7 million for (i) new 5.75% $23.7 million aggregate principal amount of Senior Convertible notes due 2021 (the “2021” notes) and (ii) an aggregate of 973,236 shares of its common stock. In addition, the conversion rate was adjusted from $34 per share to $5.15 per share. The 2021 notes were issued at the closing of the exchange on October 23, 2017. The Company analyzed this exchange and concluded that the exchange represents an extinguishment of the 2018 notes and recorded a $0.8 million loss on extinguishment of debt during the last quarter of fiscal year 2017. In addition, unamortized debt issuance costs of $0.3 million and unamortized debt premium of $0.2 million were also written-off during the last quarter of fiscal year 2017. The 2021 notes are the Company’s general, unsecured, senior obligations, except that they are subordinated in right of payment to the Facility Financing Obligation. The 2021 notes rank equally in right of payment with the Company’s other unsecured senior debt. The 2021 notes bear interest at the rate of 5.75% per year on the principal amount, payable semiannually in arrears in cash or, at the option of the Company if certain conditions are met, in shares of the Company’s common stock (the “Interest Shares”), on February 15 and August 15 of each year, beginning February 15, 2018, with interest accruing from August 15, 2017. To date, the interest on the Company’s 2021 notes have been paid in cash and not converted. The aggregate number of Interest Shares that the Company may issue may not exceed 13,648,300, unless the Company receives stockholder approval to issue Interest Shares in excess of such a number in accordance with the listing standards of the NASDAQ Global Market. Accrued interest related to these notes is recorded in accrued expenses and other current liabilities on the accompanying condensed consolidated balance sheets. The 2021 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 194.1748 shares per $1,000 principal amount of 2021 notes, which is equal to the initial conversion price of approximately $5.15 per share. The conversion rate is subject to adjustment under certain circumstances described in an indenture governing the 2021 notes. If the Company undergoes certain fundamental changes, except in certain circumstances, each holder of 2021 notes will have the option to require the Company to repurchase all or any portion of that holder’s 2021 notes. The fundamental change repurchase price will be 100% of the principal amount of the 2021 notes to be repurchased plus accrued and unpaid interest, if any. The Company may elect at its option to cause all or any portion of the 2021 notes to be mandatorily converted in whole or part at any time prior to the close of business on the business day immediately preceding the maturity date, if the last reported sale price of its common stock exceeds 120% of the conversion price then in effect for at least 10 trading days in any 20 consecutive trading day period, ending within five business days prior to the date of the mandatory conversion notice. The redemption price is equal the sum of 100% of the principal amount of the 2021 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 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 2021 notes under existing commitments. Applying the Company’s sequencing policy, the Company performed an analysis at the time of the offering of the 2021 notes and each reporting date since and has concluded that the number of available authorized shares at the time of the offering and each reporting date since was sufficient to deliver the number of shares that could be required to be delivered during the term of the 2021 notes under existing commitments. The 2021 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. As a result of the exchange of the 2021 notes during the last quarter of 2017, the Company recorded approximately $0.8 million in debt premium, which is recorded with the 2021 notes, in the accompanying condensed consolidated balance sheets. The premium is being accreted to interest expense using the effective interest method over the term of the 2021 notes. Amortization of the premium and accretion of debt issuance costs related to the 2021 and 2018 notes for the three months ended March 31, 2018 and 2017 are as follows: Three Months Ended March 31, 2018 2017 Amortization of debt premium $ 43 $ 59 Accretion expense - debt issuance cost — $ 66 Refer to Note 6 – Related Party Arrangements for information regarding the Note payable to related party. |
Collaboration Arrangements
Collaboration Arrangements | 3 Months Ended |
Mar. 31, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Collaboration Arrangements | 8. Collaboration Arrangements Receptor Collaboration and License Agreement — In 2016 the Company entered into a Collaboration and License Agreement (the “CLA”) with Receptor Life Sciences, Inc. (“Receptor”) pursuant to which Receptor obtained the option to acquire an exclusive license to develop, manufacture and commercialize certain products that use the Company’s technology to deliver the compounds via oral inhalation. On December 30, 2016 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 $1.0 million license fee received in 2016 was recorded in deferred revenue from collaboration as of December 31, 2016 and is being recognized in net revenue — collaboration over four years, the estimated period over which the Company was required to satisfy the remaining performance obligations. The remaining performance obligations are to provide certain technology transfer activities and to maintain certain patents. Deferred payments from collaboration related to this contract was $0.7 million at March 31, 2018 of which $0.3 million was recorded in current liabilities. The additional payments referred to above represent variable consideration for which the Company has not recognized any revenue because it is uncertain that Receptor will be able to successfully develop, manufacture or sell product related to this license. Therefore, the receipt of such payments is highly susceptible to factors outside of the Company’s influence, the uncertainty regarding the receipt of these payments is not expected to be resolved for years, and the Company has limited experience with similar contracts. There was no change to the accounting for this contract as a result of the initial application of the new revenue guidance. See Note 1 – Description of Business and Summary of Significant Accounting Policies for additional information on the Company’s revenue recognition accounting policy In 2017, the Company entered into a Manufacturing and Supply Agreement with Receptor pursuant to which the Company will provide certain raw materials to Receptor and agreed to provide certain additional research and formulation consulting services to Receptor. For the three months ended March 31, 2018 and 2017 the additional research and formulation services provided to Receptor were de minimis Sanofi License Agreement and Sanofi Supply Agreement — In 2014 the Company entered into a license and collaboration and supply agreement with Sanofi, pursuant to which Sanofi was responsible for global commercial, regulatory and development activities for Afrezza. In 2016, the agreements were terminated and the Company assumed responsibility for the worldwide development and commercialization of Afrezza from Sanofi. Also in 2016, the Company entered into a settlement agreement with Sanofi. The settlement was accounted for in 2016, except for a $30.6 million cash payment received under an insulin put option agreement which reduced the receivable from Sanofi in the first quarter of 2017. |
Sale of Intellectual Property
Sale of Intellectual Property | 3 Months Ended |
Mar. 31, 2018 | |
Goodwill And Intangible Assets Disclosure [Abstract] | |
Sale of Intellectual Property | 9. Sale of Intellectual Property On entered agreement paid one-time payment See Note 1 — Description of Business and Summary of Significant Accounting Policies for additional information on the Company’s revenue recognition policies. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 3 Months Ended |
Mar. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | 10. Fair Value of Financial Instruments 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. The Company uses the exit price method for estimating the fair value of loans for disclosure purposes. Cash Equivalents and restricted cash — Cash equivalents consist of highly liquid investments with original or remaining maturities of 90 days or less at the time of purchase that are readily convertible into cash. As of March 31, 2018 and December 31, 2017, the Company held $23.4 million and $41.0 million, respectively, of cash equivalents. Restricted cash is held in an escrow account as well as used to collateralize a letter of credit. The Company held $0.5 million and $4.4 million in restricted cash as of March 31, 2018 and December 31, 2017, respectively. Both are comprised of money market funds. The fair value of these money market funds was determined by using quoted prices for identical investments in an active market (Level 1 in the fair value hierarchy). Note Payable to Related Party — As of December 31, 2017, prior to the adoption of ASC 2016-01, the fair value of the note payable to related party could not be reasonably estimated as the Company was not able to obtain a similar credit arrangement in the current economic environment. Therefore the fair value is based upon carrying value as of December 31, 2017. The fair value measurement of the note payable is sensitive to the change in interest rate. If the interest rate changes by approximately 1%, the fair value of the note payable would change by $1 million or 1.4%. Financial Liabilities — The following tables set forth the fair value of the Company’s financial instruments (in millions): As of March 31, 2018 Carrying Amount Significant Unobservable Inputs (Level 3) Fair Value Financial liabilities: Senior convertible notes (2021 notes) $ 24.4 $ 19.9 $ 19.9 Facility financing obligation 43.7 50.1 50.1 Note payable to related party 72.2 68.8 68.8 Milestone rights 8.9 17.8 17.8 Total financial liabilities $ 149.2 $ 156.6 $ 156.6 As of December 31, 2017 Carrying Value Significant Unobservable Inputs (Level 3) Fair Value Financial liabilities: Senior convertible notes (2021 notes) $ 24.4 $ 19.8 $ 19.8 Facility financing obligation 52.7 54.6 54.6 Milestone rights 8.9 19.1 19.1 Total financial liabilities $ 86.0 $ 93.5 $ 93.5 Milestone Rights Liability — The fair value measurement of the milestone rights liability is sensitive to the discount rate and the timing and probability of making milestone payments. If the achievement of each of the milestones which require payments were to be six months later than in the current forecast, the fair value of the liability would decrease by 8%. If the probabilities of meeting the $50 to $200 million milestones were to decrease by 5% or 10%, the fair value of the liability would decrease by 13% and 25%, respectively. Over the long term, these inputs are interrelated because if the Company’s performance improves, the timing of meeting the milestones would likely be earlier, the probability of making payments on the milestones would likely be higher and the discount rate would likely decrease, all of which would increase the fair value of the liability. The inverse is also true. Embedded Derivatives — The Company identified and evaluated a number of embedded features in the notes issued under the Facility Agreement to determine if they represented embedded derivatives that are required to be separated from the notes and accounted for as freestanding instruments. The Company analyzed the Tranche B notes and identified embedded derivatives, which required separate accounting. All of the embedded derivatives were determined to have a value at March 31, 2018 and December 31, 2017. |
Stock-Based Compensation Expens
Stock-Based Compensation Expense | 3 Months Ended |
Mar. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation Expense | 11. Stock-Based Compensation Expense Total stock-based compensation expense recognized in the accompanying condensed consolidated statements of operations for the three months ended March 31, 2018 and 2017 was as follows (in thousands): Three Months Ended March 31, 2018 2017 Stock-based compensation $ 1,943 $ 1,267 During the three months ended March 31, 2018, the Company issued 57,400 restricted units to certain employees which vest over a four-year period. The grant date fair value of the restricted stock units was $158,424 with a weighted average grant date fair value per share of $2.76. During the three months ended March 31, 2018, the Company granted certain employees stock options to purchase an aggregate of As of March 31, 2018, there were $2.8 million and $3.4 million of unrecognized compensation expense related to restricted stock units and options, respectively, that vest over the vesting period. During the three months ended March 31, 2018 and 2017, the Company recognized $1.0 million and $0.1 million of compensation costs related to the performance-based stock options, respectively. As of March 31, 2018, there was $2.4 million of unrecognized compensation costs related to stock options subject to performance conditions. 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. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 12. Commitments and Contingencies Guarantees and Indemnifications — In the ordinary course of its business, the Company makes certain indemnities, commitments and guarantees under which it may be required to make payments in relation to certain transactions. The Company, as permitted under Delaware law and in accordance with its Bylaws, indemnifies its officers and directors for certain events or occurrences, subject to certain limits, while the officer or director is or was serving at the Company’s request in such capacity. The term of the indemnification period is for the officer’s or director’s lifetime. The maximum amount of potential future indemnification is unlimited; however, the Company has a director and officer insurance policy that may enable it to recover a portion of any future amounts paid. The Company believes the fair value of these indemnification agreements is minimal. The Company has not recorded any liability for these indemnities in the accompanying condensed consolidated balance sheets. However, the Company accrues for losses for any known contingent liability, including those that may arise from indemnification provisions, when future payment is probable and the amount can be reasonably estimated. No such losses have been recorded to date. Litigation — The Company is subject to legal proceedings and claims which arise in the ordinary course of its business. As of March 31, 2018, the Company believes that the final disposition of such matters will not have a material adverse effect on the financial position, results of operations or cash flows of the Company and no accrual has been recorded. The Company maintains liability insurance coverage to protect the Company’s assets from losses arising out of or involving activities associated with ongoing and normal business operations. The Company records a provision for a liability when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. The Company’s policy is to accrue for legal expenses in connection with legal proceedings and claims as they are incurred. 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 the Company and certain of its officers and directors. In general, the complaints alleged that the Company 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 recently ruled that U.S. law will apply to this case. The plaintiff has appealed this ruling. The Company will vigorously defend against the claims advanced. Contingencies — In connection with the Facility Agreement, on July 1, 2013, the Company also entered into a the Milestone Agreement with the Milestone Purchasers, pursuant to which the Company sold the Milestone Purchasers the Milestone Rights to receive payments up to $90.0 million upon the occurrence of specified strategic and sales milestones, including the first commercial sale of an Afrezza product in the United States and the achievement of specified net sales figures (see Note 7 – Borrowings). Commitments — On July 31, 2014, the Company entered into a supply agreement (the “Insulin Supply Agreement”) with Amphastar France Pharmaceuticals S.A.S., a French corporation (“Amphastar”), pursuant to which Amphastar manufactures for and supplies to the Company certain quantities of recombinant human insulin for use in Afrezza. Under the terms of the Insulin Supply Agreement, Amphastar is responsible for manufacturing the insulin in accordance with the Company’s specifications and agreed-upon quality standards. 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 2018 through 2023 total an aggregate purchase price of €90.3 million at March 31, 2018. 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 were reduced from $5.3 million for the period October 1, 2016 through 2018 to $3.4 million over the same period. The annual purchase requirements under the contract are as follows: 2018 € 8.9 million 2019 € 11.6 million 2020 € 15.5 million 2021 € 15.5 million 2022 € 19.4 million 2023 € 19.4 million The Company took delivery of the required amount of insulin under the contract in 2017 but was only obligated to pay for half prior to December 31, 2017. Accordingly, approximately $1.6 million was included in accounts payable at December 31, 2017 related to the 2017 purchase commitment, which was paid during the three months ended March 31, 2018. Unless terminated earlier, 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. On April 2, 2018, the Company entered into a foreign currency hedging transaction to mitigate its exposure to foreign currency exchange risks. The hedging transaction hedges against short-term currency fluctuations for the current year annual purchase requirement amount of €8.9 million and is renewable every 90 days. At March 31, 2018, the Company has other firm commitments with suppliers for an aggregate of $0.3 million. Vehicle Leases – The Company entered into a lease agreement with Enterprise for the lease of approximately 100 vehicles. The lease will require monthly payments of approximately $54,000 per month plus the cost of maintaining the vehicles. The leases will commence when the Company takes possession of the vehicles in May 2018. The leases expire 48 months after the delivery date. On March 8, 2018 the Company entered into a standby letter of credit for a total of $0.5 million in connection with the Company’s sales force vehicle lease program. The letter of credit is collateralized by a restricted cash account in the amount of $0.5 million. There were no amounts drawn down on this letter of credit as of March 31, 2018. Office Lease — On May 5, 2017, the Company executed an office lease with Russell Ranch Road II LLC for the Company’s corporate headquarters in Westlake Village, California. The office lease commenced in August 2017. The lease requires monthly payments of $40,951, increased by 3% annually, plus the estimated cost of maintaining the property by the landlord with a five month concession from October 2017 through February 2018. The lease expires January 2023 and provides the Company with a five year renewal option. On November 29, 2017, the Company executed an office lease with Russell Ranch Road II LLC to expand the office space for the Company’s corporate headquarters in Westlake Village, California. The office lease will commence in October 2018. The lease requires monthly payments of $35,969, increased by 3% annually, plus the estimated cost of maintaining the property by the landlord. In addition, the Company will be entitled to reimbursement from the landlord of up to $56,325 for tenant improvements. The lease expires January 2023 and provides the Company with a five year renewal option. Rental expense under all operating leases including office space and equipment was approximately $0.1 million for the three months ended March 31, 2018. Future minimum lease payments are as follows: 2018 $ 522,000 2019 947,000 2020 976,000 2021 1,005,000 2022 1,035,000 Thereafter 88,000 $ 4,573,000 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 13. 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. On December 22, 2017, the Tax Cuts and Jobs Act of 2017 (the “Act”) was signed into law making significant changes to the Internal Revenue Code of 1986, as amended. The adoption had no impact on its income tax expense upon adoption for the period in which the legislation was enacted. The provisional amount related to the remeasurement of certain deferred tax assets and liabilities is based on the rates at which they are expected to reverse in the future. The impact of this Act was a decrease of deferred tax assets of approximately $301 million, offset by a decrease in valuation allowance of $301 million, resulting in no additional income tax expense or benefit. No provisional amount was recorded related to the one-time transition tax on the mandatory deemed repatriation of foreign earnings. |
Restructuring Charges
Restructuring Charges | 3 Months Ended |
Mar. 31, 2018 | |
Restructuring And Related Activities [Abstract] | |
Restructuring Charges | 14. Restructuring Charges As of March 31, 2018 and December 31, 2017, the Company had a remaining restructuring liability of $0.4 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 second quarter of 2018. A reconciliation of beginning and ending liability balances for the restructuring charges is as follows (in thousands): 2015 Description Restructuring Accrual - January 1, 2018 $ 362 Costs paid or settled — Accrual - March 31, 2018 $ 362 |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2018 | |
Subsequent Events [Abstract] | |
Subsequent Events | 15. Subsequent Events On April 5, 2018, the Company entered into securities purchase agreements (the “Purchase Agreements”) with certain institutional investors (the “Purchasers”). Pursuant to the terms of the Purchase Agreements, the Company sold to the Purchasers in a registered offering an aggregate of 14,000,000 shares of its common stock and warrants to purchase up to an aggregate of 14,000,000 shares of its common stock at a combined purchase price of $2.00 per share and accompanying warrant. The shares of the common stock and the warrants were immediately separable. The warrants will be exercisable at a price of $2.38 per share beginning six months following the date of issuance and will expire six months thereafter. The net proceeds to the Company from the offering were approximately $26.3 million. The offering closed on April 9, 2018. On May 8, 2018, MannKind Corporation and Cipla Ltd. entered into an exclusive agreement for the marketing and distribution of Afrezza in India. Under the terms of the agreement, Cipla will be responsible for obtaining regulatory approvals to distribute Afrezza in India and for all marketing and sales activities of Afrezza in India. MannKind is responsible for supplying Afrezza to Cipla. MannKind will receive a $2.2 million upfront payment from Cipla upon entering the agreement, with the potential to receive certain additional regulatory milestone payments, minimum purchase commitment revenue and royalties on Afrezza sales in India once cumulative gross sales have reached a specified threshold. |
Description of Business and S22
Description of Business and Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2018 | |
Accounting Policies [Abstract] | |
Business | Business — MannKind is a biopharmaceutical company focused on the development and commercialization of inhaled therapeutic products for diseases such as diabetes and pulmonary arterial hypertension. The Company’s only approved product, Afrezza (insulin human) Inhalation Powder, is a rapid-acting inhaled insulin that was approved by the U.S. Food and Drug Administration (the “FDA”) in June of 2014 to improve glycemic control in adults with diabetes. Afrezza became available by prescription in U.S. retail pharmacies in February 2015. Pursuant to a license and collaboration agreement (the “Sanofi License Agreement”) between the Company and Sanofi-Aventis U.S. LLC (“Sanofi”), Sanofi was responsible for global commercial, regulatory and development activities associated with Afrezza from August 2014 to April 2016, after which these responsibilities transitioned back the Company. Currently, the Company promotes Afrezza to endocrinologists and certain high-prescribing primary care physicians in the United States through its own specialty sales force. Outside of the United States, subject to receipt of the necessary foreign regulatory approvals, the Company is seeking to establish regional partnerships for the commercialization of Afrezza in foreign jurisdictions where there are commercial opportunities. |
Basis of Presentation | Basis of Presentation - The accompanying condensed consolidated financial statements have been prepared assuming that the Company will continue as a going concern which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The Company is not currently profitable and has rarely generated positive net cash flow from operations. As of March 31, 2018, the Company had an accumulated deficit of $2.9 billion. At March 31, 2018, the Company’s capital resources consisted of cash and cash equivalents of $26.7 million. The Company expects to continue to incur significant expenditures to support commercial manufacturing, 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 7 — Borrowings) requires the Company to maintain at least $25.0 million in cash and cash equivalents or certain available borrowings (which are no longer available) as of the last day of each fiscal quarter. As of March 31, 2018, the Company has $140.2 million principal amount of outstanding borrowings. The Company has entered into certain transactions related to these borrowings during 2017 and 2018 that are more fully described in Note 6 — Related-Party Arrangements, and Note 7 – Borrowings. The Company’s current available cash and financing sources will not be sufficient to meet its current and anticipated cash requirements. The Company plans 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. Successful completion of these plans is dependent on factors outside of the Company’s control. As such, management cannot be certain that such plans will be effectively implemented within one year after the date that the financial statements are issued. 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. |
Reverse Stock-Split | Reverse Stock-Split - On March 1, 2017, following stockholder approval, the Company’s board of directors approved a 1-for-5 reverse stock split of its outstanding common stock. 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, prior to March 3, 2017, 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. |
Principles of Consolidation | Principles of Consolidation – The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. Intercompany balances and transactions have been eliminated. |
Segment Information | Segment Information – Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. To date, the Company has viewed its operations and manages its business as one segment operating in the United States of America. |
Revenue Recognition | Revenue Recognition — The Company adopted Accounting Standards Codification (“ASC”) Topic 606 - Revenue from Contracts with Customers (“the new revenue guidance”), on January 1, 2018. Under Topic 606, the Company recognizes revenue when its customers obtain control of promised goods or services, in an amount that reflects the consideration which the Company expects to be entitled in exchange for those goods or services. See below for more information about the impact of adoption of the new revenue guidance. To determine revenue recognition for arrangements that are within the scope of Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to arrangements that meet the definition of a contract under Topic 606, including when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company has three types of contracts with customers: contracts with wholesale distributors and specialty pharmacies for commercial product sales, collaboration arrangements, and arrangements with parties to whom it has sold intellectual property. |
Revenue Recognition - Net Revenue - Commercial Product Sales | Revenue Recognition – Net Revenue – Commercial Product Sales – The Company sells Afrezza to a limited number of wholesale distributors and specialty pharmacies in the U.S. (collectively, its “Customers”). These Customers subsequently resell the Company’s products to retail pharmacies and certain medical centers or hospitals. Specialty pharmacies sell directly to patients. In addition to distribution agreements with Customers, the Company enters into arrangements with health care providers and payors that provide for government mandated and/or privately negotiated rebates, chargebacks, and discounts with respect to the purchase of the Company’s products. The Company recognizes revenue on product sales when the Customer obtains control of the Company's product, which occurs at a point in time (based on the terms of the relevant contracts which are at delivery for wholesale distributors and at shipment for specialty pharmacies). Product revenues are recorded net of applicable reserves for variable consideration, including discounts and allowances. Voucher Program – Under the voucher program, potential new patients are given vouchers which they can provide to retailers for a free product. The retailers provide the product to the patient for free and pay the wholesaler for the product, who pays the Company. The retailers submit the vouchers to a program administrator which pays the retailer for the product. The administrator then invoices the Company for the amount of vouchers paid plus a fee. Accordingly, on a net basis, it is not probable that the Company will receive the consideration to which it is entitled for these products. Therefore, the Company excludes such amounts from both gross and net revenue. The cost of product associated with the voucher program is included in cost of goods sold. Reserves for Variable Consideration — Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade discounts and allowances, product returns, provider chargebacks and discounts, government rebates, payor rebates, and other incentives, such as voluntary patient assistance, and other allowances that are offered within contracts between the Company and its Customers, payors, and other indirect customers relating to the Company’s sale of its products. These reserves, as detailed below, are based on the amounts earned, or to be claimed on the related sales, and result in a reduction of accounts receivable or establishment of a current liability. Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted in accordance with the expected value method in Topic 606 for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reduce recognized revenue to the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts. The amount of variable consideration which is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. The Company’s analyses also contemplates application of the constraint in accordance with the guidance, under which it determined a material reversal of revenue would not occur in a future period for the estimates detailed below as of March 31, 2018 and, therefore, the transaction price was not reduced further during the three months ended March 31, 2018. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net revenue – commercial product sales and earnings in the period such variances become known. Trade Discounts and Allowances — The Company generally provides Customers with discounts which include incentive fees, such as prompt pay discounts, that are explicitly stated in the Company’s contracts and are recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, the Company compensates (through trade discounts and allowances) its Customers for sales order management, data, and distribution services. However, the Company has determined such services received to date are not distinct from the Company’s sale of products to the Customer and, therefore, these payments have been recorded as a reduction of revenue and a reduction to accounts receivable, net. Product Returns — Consistent with industry practice, the Company generally offers Customers a right of return for unopened product that has been purchased from the Company for a period beginning six months prior to and ending twelve months after its expiration date , which lapses upon shipment to a patient. The Company estimates the amount of its product sales that may be returned by its Customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as reductions to accounts receivable, net. The Company currently estimates product returns using available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel. The Company currently estimates that 2.46% of products will be returned. Provider Chargebacks and Discounts — Chargebacks for fees and discounts to providers represent the estimated obligations resulting from contractual commitments to sell products to qualified healthcare providers at prices lower than the list prices charged to Customers who directly purchase the product from the Company. Customers charge the Company for the difference between what they pay for the product and the ultimate selling price to the qualified healthcare providers. These reserves are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is recorded in accrued expenses and other current liabilities. Chargeback amounts are generally determined at the time of resale to the qualified healthcare provider by Customers, and the Company generally issues credits for such amounts within a few weeks of the Customer’s notification to the Company of the resale. Reserves for chargebacks consist of credits that the Company expects to issue for units that remain in the distribution channel inventories at each reporting period-end that the Company expects will be sold to qualified healthcare providers, and chargebacks that Customers have claimed, but for which the Company has not yet issued a credit. Government Rebates — The Company is subject to discount obligations under state Medicaid programs and Medicare. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period. Payor Rebates — The Company contracts with certain private payor organizations, primarily insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of its products. The Company estimates these rebates and records such estimates in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities. Other Incentives — Other incentives which the Company offers include voluntary patient support programs, such as the Company's co-pay assistance program, which are intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payors. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities. As of December 31, 2017, prior to the adoption of Topic 606, the ending balance for net deferred revenue, was $3.0 million, on the Company’s condensed consolidated balance sheets which is presented net of $1.5 million in gross-to-net revenue adjustments. On January 1, 2018, deferred revenue was adjusted to zero as a result of the adoption of Topic 606 as disclosed below. For the three months ended March 31, 2018 and 2017, shipments to three wholesale distributors represented 87% and 93% of total shipments, respectively. |
Revenue Recognition- Net Revenue - Collaborations | Revenue Recognition – Net Revenue – Collaborations — The Company enters into out-licensing agreements under which the Company licenses certain rights to its product candidates to third parties. The terms of these arrangements may include payment to the Company of one or more of the following: non-refundable, up-front license fees; development, regulatory, and commercial milestone payments; payments for manufacturing supply services the Company provides; and royalties on net sales of licensed products and sublicenses of the rights. Each of these payments may result in license, collaboration, or other revenue, except revenue from royalties on net sales of licensed products, which would be classified as royalty revenue. As part of the accounting for these arrangements, the Company must develop assumptions that require judgment to determine the stand-alone selling price for each performance obligation identified in the contract. The Company uses key assumptions to determine the stand-alone selling price, which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates, and probabilities of technical and regulatory success. |
Licenses of Intellectual Property | Licenses of Intellectual Property — If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company will evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. Revenue from licenses of intellectual property is included in Net revenue - Collaboration in the condensed consolidated statement of operations. |
Milestone Payments | Milestone Payments — At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the customer, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as, or when, the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company will re-evaluate the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration, other revenue, and earnings in the period of adjustment. |
Manufacturing Supply Services | Manufacturing Supply Services — Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply, at the customer’s discretion, are generally considered as options. The Company assesses if these options provide a material right to the licensee and, if so, they are accounted for as separate performance obligations. If the Company is entitled to additional payments when the licensee exercises these options, any additional payments are recorded in license, collaboration, or other revenue when the customer obtains control of the goods, which is upon delivery. |
Royalties | Royalties — For licensing arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all the royalty has been allocated has been satisfied (or partially satisfied). For sales of intellectual property that include sales-based royalties, the Company estimates the amount of variable consideration that it will receive from the sales-based royalty. The Company has not recognized any royalty revenue resulting from the sale of its intellectual property in 2017 which is more fully described in Note 9, Sale of Intellectual Property. |
Revenue Recognition - Revenue - Other | Revenue Recognition — Revenue — Other — For the three months ended March 31, 2017, revenue-other consists of $1.7 million of revenue from bulk insulin sales. |
Cost of Goods Sold | Cost of Goods Sold — A significant component of cost of goods sold is current period manufacturing costs in excess of costs capitalized into inventory (excess capacity costs). These costs, in addition to the impact of the annual revaluation of inventory to standard costs (and the annual revaluation of deferred costs of commercial sales to standard costs in 2017), and write-offs of inventory (and write-offs of deferred costs of commercial sales in 2017) are recorded as expenses in the period in which they are incurred, rather than as a portion of inventory costs. Cost of goods sold also includes the standard cost related to Afrezza sold during the period and related variances. |
Restricted Cash | Restricted Cash – The Company records restricted cash when cash and cash equivalents are restricted as to withdrawal or usage. The Company presents amounts of restricted cash that will be available for use within twelve months of the reporting date as restricted cash in current assets. Restricted cash amounts that will not be available for use in the Company’s operations within twelve months of the reporting date are presented as restricted cash in long term assets. |
Accounts Receivable and Allowance for Doubtful Accounts | Accounts Receivable and Allowance for Doubtful Accounts — Accounts receivable are recorded at the invoiced amount and are not interest bearing. Accounts receivable are presented net of an allowance for doubtful accounts if there are estimated losses resulting from the inability of its customers to make required payments. The Company makes ongoing assumptions relating to the collectability of its accounts receivable in its calculation of the allowance for doubtful accounts. Accounts receivable are also presented net of an allowance for product returns and trade discounts and allowances because the Company’s customers have the right of setoff for these amounts against the related accounts receivable. |
Inventories | Inventories — Inventories are stated at the lower of cost or net realizable value. The Company determines the cost of inventory using the first-in, first-out, or FIFO, method. The Company capitalizes inventory costs associated with the Company’s products based on management’s judgment that future economic benefits are expected to be realized; otherwise, such costs are expensed as incurred as cost of goods sold. The Company periodically analyzes its inventory levels to identify inventory that may expire or has a cost basis in excess of its estimated realizable value and writes down such inventories, as appropriate. In addition, the Company’s products are subject to strict quality control and monitoring which the Company performs throughout the manufacturing process. If certain batches or units of product no longer meet quality specifications or may become obsolete or are forecasted to become obsolete due to expiration, the Company will record a charge to write down such unmarketable inventory to its estimated net realizable value. |
Leases | Leases – The Company records rent expense for leases that contain scheduled rent increases on a straight-line basis over the lease term which begins with the point at which the Company obtains control and possession of the leased property. |
Recognized Loss on Purchase Commitments | Recognized Loss on Purchase Commitments — The Company assesses whether losses on long term purchase commitments should be accrued. Losses that are expected to arise from firm, non-cancellable, commitments for the future purchases are recognized unless recoverable. When making the assessment, the Company also considers whether it is able to renegotiate with its vendors. The recognized loss on purchase commitments is reduced as inventory items are received. If, subsequent to an accrual, a purchase commitment is successfully renegotiated, the gain is recognized in the Company’s condensed consolidated statement of operations. The liability balance of the recognized loss on insulin purchase commitments is $112.3 million as of March 31, 2018. No new contracts were identified in 2018 or 2017 that required a new loss on purchase commitment accrual. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments — The Company applies various valuation approaches in determining the fair value of its financial assets and liabilities within a hierarchy that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that observable inputs be used when available. Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances. The fair value hierarchy is broken down into three levels based on the source of inputs as follows: Level 1 — Quoted prices for identical instruments in active markets. Level 2 — Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable. Level 3 — Significant inputs to the valuation model are unobservable. |
Contingencies | Contingencies — The Company records a loss contingency for a liability when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. These accruals represent management’s best estimate of probable loss. Disclosure also is provided when it is reasonably possible that a loss will be incurred or when it is reasonably possible that the amount of a loss will exceed the recorded provision. On a quarterly basis, the Company reviews the status of each significant matter and assesses its potential financial exposure. Significant judgment is required in both the determination of probability and the determination as to whether an exposure is reasonably estimable. Because of uncertainties related to these matters, accruals are based only on the best information available at the time. As additional information becomes available, the Company reassesses the potential liability related to pending claims and litigation and may revise its estimates. |
Stock-Based Compensation | Stock-Based Compensation — Share-based payments to employees, including grants of stock options, restricted stock units, performance-based awards and the compensatory elements of employee stock purchase plans, are recognized in the condensed consolidated statements of operations based upon the fair value of the awards at the grant date subject to an estimated forfeiture rate. The Company uses the Black-Scholes option valuation model to estimate the grant date fair value of employee stock options and the compensatory elements of employee stock purchase plans. Restricted stock units are valued based on the market price on the grant date. The Company evaluates stock awards with performance conditions as to the probability that the performance conditions will be met and estimates the date at which the performance conditions will be met in order to properly recognize stock-based compensation expense over the requisite service period. |
Clinical Trial Expenses | Clinical Trial Expenses — Clinical trial expenses, which are primarily reflected in research and development expenses in the accompanying condensed consolidated statements of operations, result from obligations under contracts with vendors, consultants and clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to the Company under such contracts. The appropriate level of trial expenses are reflected in the Company’s condensed consolidated financial statements by matching period expenses with period services and efforts expended. These expenses are recorded according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. Clinical trial accrual estimates are determined through discussions with internal clinical personnel and outside service providers as to the progress or state of completion of trials, or the services completed. Service provider status is then compared to the contractually obligated fee to be paid for such services. During the course of a clinical trial, the Company may adjust the rate of clinical expense recognized if actual results differ from management’s estimates. |
Net Income or (Loss) Per Share of Common Stock | Net Income (Loss) Per Share of Common Stock — Basic net income or loss per share excludes dilution for potentially dilutive securities and is computed by dividing net income or loss by the weighted average number of common shares outstanding during the period. Diluted net income or loss per share reflects the potential dilution under the treasury method that could occur if securities or other contracts to issue common stock were exercised or converted into common stock. For periods where the Company has presented a net loss, potentially dilutive securities are excluded from the computation of diluted net loss per share as they would be anti-dilutive. The computation of basic and diluted net loss per share for the three months ended March 31, 2018 and 2017 excludes the common stock equivalents of the following potentially dilutive securities because their inclusion would be anti-dilutive: Three months ended March 31, 2018 2017 Vesting of restricted stock units 1,073,036 709,004 Conversion of convertible notes into common stock 14,154,500 814,561 Conversion of convertible related party notes into common stock 18,743,500 — Exercise of common stock warrants 31,856 9,740,597 Employee stock purchase plan 111,020 31,459 Exercise of common stock options 7,212,239 5,941,408 41,326,151 17,237,029 |
Impact of Adoption of the New Revenue Guidance | Impact of Adoption of the New Revenue Guidance – The Company applied the new revenue guidance using the modified retrospective approach to all contracts with the cumulative effect of initial application recognized as of January 1, 2018. The comparative information has not been restated and continues to be accounted for under the previous accounting guidance. The previous accounting guidance required the Company to reliably estimate returns in order to recognize revenue upon shipment. While the Company could estimate returns within a range, it was not sufficiently precise to meet those requirements. Accordingly, under the previous guidance, the Company deferred recognition of revenue on Afrezza product deliveries to wholesalers until the right of return no longer existed, which occurred at the earlier of the time Afrezza was dispensed from pharmacies to patients or expiration of the right of return. Therefore, for deliveries to wholesalers, the Company recognized revenue based on estimated Afrezza patient prescriptions dispensed, a sell-through model. Upon adoption of the new revenue guidance, the Company moved from the sell-through model to a sell-to model for revenue related to commercial sales of Afrezza to wholesalers and now records revenue when its customers take control of the product along with an estimate of potential returns as variable consideration. For sales of Afrezza to specialty pharmacies, the Company previously recognized revenue at the time of shipment because specialty pharmacies generally purchase on demand and estimated returns are minimal. Therefore, there was no impact upon adoption for sales to specialty pharmacies. Additionally, the Company has historically entered into collaborative agreements and sales of intellectual property to third parties under which periodic payments have been received. In February 2017, the FASB issued ASU 2017-05 Clarifying the Scope of Asset Derecognition Guidance and Accounting for Partial Sales of Nonfinancial Assets to ASC Subtopic 610-20, Other Income-Gains and Losses from the Derecognition of Nonfinancial Assets The cumulative effect of the changes made to the condensed consolidated January 1, 2018 balance sheet for the adoption of the new revenue guidance were as follows (in thousands): Balance at December 31, 2017 Adjustments due to new revenue guidance Balance at January 1, 2018 Assets Accounts receivable, net $ 2,789 $ (111 ) (1) $ 2,678 Deferred costs from commercial product sales 405 (405 ) (2) — Liabilities Accrued expenses and other current liabilities $ 12,449 $ 649 (3) $ 13,098 Deferred revenue, net 3,038 (3,038 ) (4) — Equity Accumulated deficit $ (2,854,898 ) $ 1,873 (5) $ (2,853,025 ) (1) To establish a reserve for product returns (2) To eliminate deferred costs from commercial product sales previously required by the sell-through method (3) To record additional accrual for estimated voucher payments related to inventory remaining in the distribution channel at January 1, 2018 (4) To eliminate deferred revenue previously required by the sell-through method (5) To record the net impact of (1)-(4) in opening accumulated deficit In accordance with the new revenue guidance, the disclosure of the impact of adoption on the condensed consolidated balance sheet and the condensed consolidated statement of operations and cash flows was as follows (in thousands): Condensed Consolidated Balance Sheet For the three months ended March 31, 2018 As Reported Adjustments Balances without adoption of Topic 606 Assets Accounts receivable, net $ 1,550 $ 130 $ 1,680 Deferred costs from commercial product sales — 361 361 Liabilities Accrued expenses and other current liabilities $ 15,930 $ (479 ) $ 15,451 Deferred revenue, net — 2,298 2,298 Equity Accumulated deficit $ (2,883,410 ) $ (1,328 ) $ (2,884,738 ) Condensed Consolidated Statement of Operations For the three months ended March 31, 2018 As Reported Adjustments Balances without adoption of Topic 606 Revenue Net revenue - commercial product sales $ 3,402 $ 589 $ 3,991 Expenses Cost of goods sold $ 4,008 $ 44 $ 4,052 Net loss (30,385 ) 545 (29,840 ) Condensed Consolidated Statement of Cash Flows For the three months ended March 31, 2018 As Reported Adjustments Balances without adoption of Topic 606 Cash Flows from Operating Activities Net loss $ (30,385 ) $ 545 $ (29,840 ) Change in: Accounts receivable, net 1,128 (18 ) 1,110 Deferred costs from commercial product sales — 44 44 Accrued expenses and other current liabilities 2,675 171 2,846 Deferred revenue, net — (740 ) (740 ) Cash (used in) provided by operating activities (21,650 ) 2 (21,648 ) |
Recently Issued Accounting Standards | Recently Issued Accounting Standards – From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that are adopted by the Company as of the specified effective date. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s condensed consolidated financial position or results of operations upon adoption. In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 84 |
Description of Business and S23
Description of Business and Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Summary Of Significant Accounting Policies [Line Items] | |
Schedule of Potentially Dilutive Common Stock Equivalent Securities | The computation of basic and diluted net loss per share for the three months ended March 31, 2018 and 2017 excludes the common stock equivalents of the following potentially dilutive securities because their inclusion would be anti-dilutive: Three months ended March 31, 2018 2017 Vesting of restricted stock units 1,073,036 709,004 Conversion of convertible notes into common stock 14,154,500 814,561 Conversion of convertible related party notes into common stock 18,743,500 — Exercise of common stock warrants 31,856 9,740,597 Employee stock purchase plan 111,020 31,459 Exercise of common stock options 7,212,239 5,941,408 41,326,151 17,237,029 |
Accounting Standards Update 2014-09 | |
Summary Of Significant Accounting Policies [Line Items] | |
Schedule of Cumulative Effect of Changes to Condensed Consolidated Balance Sheet for Adoption of New Revenue Guidance | The cumulative effect of the changes made to the condensed consolidated January 1, 2018 balance sheet for the adoption of the new revenue guidance were as follows (in thousands): Balance at December 31, 2017 Adjustments due to new revenue guidance Balance at January 1, 2018 Assets Accounts receivable, net $ 2,789 $ (111 ) (1) $ 2,678 Deferred costs from commercial product sales 405 (405 ) (2) — Liabilities Accrued expenses and other current liabilities $ 12,449 $ 649 (3) $ 13,098 Deferred revenue, net 3,038 (3,038 ) (4) — Equity Accumulated deficit $ (2,854,898 ) $ 1,873 (5) $ (2,853,025 ) (1) To establish a reserve for product returns (2) To eliminate deferred costs from commercial product sales previously required by the sell-through method (3) To record additional accrual for estimated voucher payments related to inventory remaining in the distribution channel at January 1, 2018 (4) To eliminate deferred revenue previously required by the sell-through method (5) To record the net impact of (1)-(4) in opening accumulated deficit |
Schedule of Adoption of New Revenue Guidance Impact on Financial Statements | In accordance with the new revenue guidance, the disclosure of the impact of adoption on the condensed consolidated balance sheet and the condensed consolidated statement of operations and cash flows was as follows (in thousands): Condensed Consolidated Balance Sheet For the three months ended March 31, 2018 As Reported Adjustments Balances without adoption of Topic 606 Assets Accounts receivable, net $ 1,550 $ 130 $ 1,680 Deferred costs from commercial product sales — 361 361 Liabilities Accrued expenses and other current liabilities $ 15,930 $ (479 ) $ 15,451 Deferred revenue, net — 2,298 2,298 Equity Accumulated deficit $ (2,883,410 ) $ (1,328 ) $ (2,884,738 ) Condensed Consolidated Statement of Operations For the three months ended March 31, 2018 As Reported Adjustments Balances without adoption of Topic 606 Revenue Net revenue - commercial product sales $ 3,402 $ 589 $ 3,991 Expenses Cost of goods sold $ 4,008 $ 44 $ 4,052 Net loss (30,385 ) 545 (29,840 ) Condensed Consolidated Statement of Cash Flows For the three months ended March 31, 2018 As Reported Adjustments Balances without adoption of Topic 606 Cash Flows from Operating Activities Net loss $ (30,385 ) $ 545 $ (29,840 ) Change in: Accounts receivable, net 1,128 (18 ) 1,110 Deferred costs from commercial product sales — 44 44 Accrued expenses and other current liabilities 2,675 171 2,846 Deferred revenue, net — (740 ) (740 ) Cash (used in) provided by operating activities (21,650 ) 2 (21,648 ) |
Accounts Receivable (Tables)
Accounts Receivable (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Receivables [Abstract] | |
Schedule of Accounts Receivable, Net | Accounts receivable, net consists of the following (in thousands): March 31, 2018 December 31, 2017 Accounts receivable, gross $ 2,019 $ 2,842 Wholesaler distribution fees and prompt pay discounts (340 ) (53 ) Reserve for returns (129 ) — Accounts receivable, net $ 1,550 $ 2,789 |
Inventories (Tables)
Inventories (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Inventory Disclosure [Abstract] | |
Components of Inventory | Inventories consist of the following (in thousands): March 31, 2018 December 31, 2017 Raw materials $ 772 $ 572 Work-in-process 2,519 1,273 Finished goods 600 812 Total inventory $ 3,891 $ 2,657 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, Net | Property and equipment consist of the following (in thousands): Estimated Useful Life (Years) March 31, 2018 December 31, 2017 Land — $ 875 $ 875 Buildings 39-40 17,389 17,389 Building improvements 5-40 34,957 34,957 Machinery and equipment 3-15 62,681 62,681 Furniture, fixtures and office equipment 5-10 3,106 3,556 Computer equipment and software 3 8,416 8,416 127,424 127,874 Less accumulated depreciation (100,943 ) (100,952 ) Total property and equipment, net $ 26,481 $ 26,922 |
Depreciation Expense Related To Property And Equipment | Depreciation expense related to property and equipment for the three months ended March 31, 2018 and 2017 was as follows (in thousands): Three Months Ended March 31, 2018 2017 Depreciation Expense $ 441 $ 446 |
Accrued Expenses and Other Cu27
Accrued Expenses and Other Current Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Payables And Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities are comprised of the following (in thousands): March 31, 2018 December 31, 2017 Salary and related expenses $ 10,474 $ 7,260 Current portion of milestone rights liability 1,643 1,643 Professional fees 872 1,007 Discounts and allowances for commercial product sales 766 873 Sales and marketing services 625 147 Restructuring 362 362 Accrued interest 226 567 Other 962 590 Accrued expenses and other current liabilities $ 15,930 $ 12,449 |
Related-Party Arrangements (Tab
Related-Party Arrangements (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Schedule of Related Party Debt | Related party debt consist of the following (in thousands): March 31, 2018 December 31, 2017 Principal amount $ 71,506 $ 79,666 Unamortized premium 815 — Unaccreted debt issuance costs (74 ) — Net carrying amount $ 72,247 $ 79,666 |
Schedule of Interest Expense on Note Payable to Related Party | Interest expense (excluding the amortization of debt premium and debt issuance costs) for the three months ended March 31, 2018 and 2017 was as follows (in thousands): Three Months Ended March 31, 2018 2017 Interest expense on note payable to related party $ 1,122 $ 714 |
Schedule of Amortization of Premium and Accretion of Debt Issuance Costs | Amortization of the premium and accretion of debt issuance costs related to the 2021 and 2018 notes for the three months ended March 31, 2018 and 2017 are as follows: Three Months Ended March 31, 2018 2017 Amortization of debt premium $ 43 $ 59 Accretion expense - debt issuance cost — $ 66 |
Related Party Notes | |
Schedule of Amortization of Premium and Accretion of Debt Issuance Costs | Amortization of the premium and accretion of debt issuance costs related to the related party notes for the three months ended March 31, 2018 and 2017 are as follows (in thousands): Three Months Ended March 31, 2018 2017 Amortization of debt premium $ 10 $ — Accretion expense - debt issuance cost $ 2 $ — |
Borrowings (Tables)
Borrowings (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Debt Disclosure [Abstract] | |
Summary of Borrowings | Borrowings consist of the following (in thousands): March 31, 2018 December 31, 2017 Facility Financing Obligation (2019 Notes and Tranche B Notes) Principal amount $ 45,000 $ 54,407 Unamortized debt issuance costs and debt discount (1,346 ) (1,662 ) Net carrying amount $ 43,654 $ 52,745 Senior Convertible Notes (2021 Notes) Principal amount $ 23,690 $ 23,690 Unamortized premium 678 721 Net carrying amount $ 24,368 $ 24,411 Note payable to related party - net carrying amount $ 72,247 $ 79,666 Total debt - net carrying amount $ 140,269 $ 156,822 |
Accretion of Debt Issuance Cost and Debt Discount | Accretion of debt issuance cost and debt discount during the three months ended March 31, 2018 and 2017, are as follows (in thousands): Three Months Ended March 31, 2018 2017 Accretion expense - debt issuance cost $ 6 $ 9 Accretion expense - debt discount $ 310 $ 447 |
Schedule of Amortization of Premium and Accretion of Debt Issuance Costs | Amortization of the premium and accretion of debt issuance costs related to the 2021 and 2018 notes for the three months ended March 31, 2018 and 2017 are as follows: Three Months Ended March 31, 2018 2017 Amortization of debt premium $ 43 $ 59 Accretion expense - debt issuance cost — $ 66 |
Fair Value of Financial Instr30
Fair Value of Financial Instruments (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | The following tables set forth the fair value of the Company’s financial instruments (in millions): As of March 31, 2018 Carrying Amount Significant Unobservable Inputs (Level 3) Fair Value Financial liabilities: Senior convertible notes (2021 notes) $ 24.4 $ 19.9 $ 19.9 Facility financing obligation 43.7 50.1 50.1 Note payable to related party 72.2 68.8 68.8 Milestone rights 8.9 17.8 17.8 Total financial liabilities $ 149.2 $ 156.6 $ 156.6 As of December 31, 2017 Carrying Value Significant Unobservable Inputs (Level 3) Fair Value Financial liabilities: Senior convertible notes (2021 notes) $ 24.4 $ 19.8 $ 19.8 Facility financing obligation 52.7 54.6 54.6 Milestone rights 8.9 19.1 19.1 Total financial liabilities $ 86.0 $ 93.5 $ 93.5 |
Stock-Based Compensation Expe31
Stock-Based Compensation Expense (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock Based Compensation Expense Recognized in Accompanying Consolidated Statements of Operations | Total stock-based compensation expense recognized in the accompanying condensed consolidated statements of operations for the three months ended March 31, 2018 and 2017 was as follows (in thousands): Three Months Ended March 31, 2018 2017 Stock-based compensation $ 1,943 $ 1,267 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Annual Purchase Requirements under Contract | The annual purchase requirements under the contract are as follows: 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: 2018 $ 522,000 2019 947,000 2020 976,000 2021 1,005,000 2022 1,035,000 Thereafter 88,000 $ 4,573,000 |
Restructuring Charges (Tables)
Restructuring Charges (Tables) | 3 Months Ended |
Mar. 31, 2018 | |
Restructuring And Related Activities [Abstract] | |
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): 2015 Description Restructuring Accrual - January 1, 2018 $ 362 Costs paid or settled — Accrual - March 31, 2018 $ 362 |
Description of Business and S34
Description of Business and Significant Accounting Policies - Additional Information (Detail) | Mar. 01, 2017shares | Mar. 31, 2018USD ($)DistributorContractshares | Mar. 31, 2017USD ($)Distributor | Dec. 31, 2017USD ($)Contractshares | Sep. 30, 2016shares |
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||
Accumulated deficit | $ (2,883,410,000) | $ (2,854,898,000) | |||
Cash and cash equivalents | 26,706,000 | $ 43,946,000 | |||
Principal amount of outstanding borrowings | $ 140,200,000 | ||||
Stock split of common stock | 0.2 | ||||
Common stock, shares authorized | shares | 140,000,000 | 280,000,000 | 280,000,000 | 700,000,000 | |
Reverse stock split, description | The Company’s board of directors approved a 1-for-5 reverse stock split of its outstanding common stock. 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, prior to March 3, 2017, 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 | $ 3,038,000 | ||||
Number of wholesale distributors | Distributor | 3 | 3 | |||
Percentage of product shipments to wholesale distributors | 87.00% | 93.00% | |||
Revenue - other | $ 1,750,000 | ||||
Third party logistics | |||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||
Net deferred revenue | $ 1,500,000 | ||||
AFREZZA product sales | |||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||
Percentage of estimated products returned | 2.46% | ||||
Bulk insulin sales | |||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||
Revenue - other | $ 1,700,000 | ||||
Insulin | |||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||
Loss on purchase commitments | $ 112,300,000 | ||||
Loss on purchase commitments, number of new contracts recognized | Contract | 0 | 0 | |||
Tranche B Notes | |||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||
Senior notes, effective interest rate | 8.75% | ||||
Principal amount of outstanding borrowings | $ 10,000,000 | ||||
Senior convertible notes due December 31, 2019 | |||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||
Senior notes, effective interest rate | 9.75% | ||||
Principal amount of outstanding borrowings | $ 35,000,000 | ||||
Senior convertible notes due December 31, 2019 | Tranche B Notes | |||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||
Principal amount of outstanding borrowings | $ 45,000,000 | $ 54,407,000 | |||
Deerfield | |||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||
Principal amount of outstanding borrowings | 39,400,000 | ||||
Deerfield | Tranche B Notes | |||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||
Principal amount of outstanding borrowings | $ 15,000,000 | ||||
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% | ||||
Deerfield | Senior convertible notes due December 31, 2019 | Tranche B Notes | |||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||
Senior notes, effective interest rate | 8.75% | ||||
Minimum | AFREZZA product sales | |||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||
Sales return right following product expiration in months | 6 months | ||||
Minimum | Deerfield | Senior convertible notes due December 31, 2019 | Tranche B Notes | |||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||
Available amount of credit facility under covenant restrictions | $ 25,000,000 | ||||
Maximum | AFREZZA product sales | |||||
Organization, Consolidation and Presentation of Financial Statements Disclosure [Line Items] | |||||
Sales return right following product expiration in months | 12 months |
Schedule of Potentially Dilutiv
Schedule of Potentially Dilutive Common Stock Equivalent Securities (Detail) - shares | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 41,326,151 | 17,237,029 |
Vesting of Restricted Stock Units | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 1,073,036 | 709,004 |
Conversion of Convertible Notes into Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 14,154,500 | 814,561 |
Conversion of Convertible Related Party Notes into Common Stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 18,743,500 | |
Exercise of Common Stock Warrants | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 31,856 | 9,740,597 |
Employee Stock Purchase Plan | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 111,020 | 31,459 |
Exercise of Common Stock Options | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from computation of earnings per share | 7,212,239 | 5,941,408 |
Schedule of Cumulative Effect o
Schedule of Cumulative Effect of Changes to Condensed Consolidated Balance Sheet for Adoption of New Revenue Guidance (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
ASSETS | |||
Accounts receivable, net | $ 1,550 | $ 2,789 | |
Deferred costs from commercial product sales | 405 | ||
Liabilities | |||
Accrued expenses and other current liabilities | 15,930 | 12,449 | |
Deferred revenue, net | 3,038 | ||
Stockholders' deficit: | |||
Accumulated deficit | (2,883,410) | $ (2,854,898) | |
Accounting Standards Update 2014-09 | |||
ASSETS | |||
Accounts receivable, net | $ 2,678 | ||
Liabilities | |||
Accrued expenses and other current liabilities | 13,098 | ||
Stockholders' deficit: | |||
Accumulated deficit | (2,853,025) | ||
Adjustment Due to New Revenue Guidance | Accounting Standards Update 2014-09 | |||
ASSETS | |||
Accounts receivable, net | 130 | (111) | |
Deferred costs from commercial product sales | 361 | (405) | |
Liabilities | |||
Accrued expenses and other current liabilities | (479) | 649 | |
Deferred revenue, net | 2,298 | (3,038) | |
Stockholders' deficit: | |||
Accumulated deficit | $ (1,328) | $ 1,873 |
Schedule of Adoption of New Rev
Schedule of Adoption of New Revenue Guidance Impact on Condensed Consolidated Balance sheet (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 |
ASSETS | |||
Accounts receivable, net | $ 1,550 | $ 2,789 | |
Deferred costs from commercial product sales | 405 | ||
Liabilities | |||
Accrued expenses and other current liabilities | 15,930 | 12,449 | |
Deferred revenue, net | 3,038 | ||
Stockholders' deficit: | |||
Accumulated deficit | (2,883,410) | $ (2,854,898) | |
Accounting Standards Update 2014-09 | |||
ASSETS | |||
Accounts receivable, net | $ 2,678 | ||
Liabilities | |||
Accrued expenses and other current liabilities | 13,098 | ||
Stockholders' deficit: | |||
Accumulated deficit | (2,853,025) | ||
Adjustments | Accounting Standards Update 2014-09 | |||
ASSETS | |||
Accounts receivable, net | 130 | (111) | |
Deferred costs from commercial product sales | 361 | (405) | |
Liabilities | |||
Accrued expenses and other current liabilities | (479) | 649 | |
Deferred revenue, net | 2,298 | (3,038) | |
Stockholders' deficit: | |||
Accumulated deficit | (1,328) | $ 1,873 | |
Balances Without Adoption of Topic 606 | Accounting Standards Update 2014-09 | |||
ASSETS | |||
Accounts receivable, net | 1,680 | ||
Deferred costs from commercial product sales | 361 | ||
Liabilities | |||
Accrued expenses and other current liabilities | 15,451 | ||
Deferred revenue, net | 2,298 | ||
Stockholders' deficit: | |||
Accumulated deficit | $ (2,884,738) |
Schedule of Adoption of New R38
Schedule of Adoption of New Revenue Guidance Impact on Condensed Consolidated Statement of Operations (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Revenues: | ||
Net revenue - commercial product sales | $ 3,402 | $ 1,196 |
Expenses: | ||
Cost of goods sold | 4,008 | 2,548 |
Net loss | (30,385) | $ (16,324) |
Adjustments | Accounting Standards Update 2014-09 | ||
Revenues: | ||
Net revenue - commercial product sales | 589 | |
Expenses: | ||
Cost of goods sold | 44 | |
Net loss | 545 | |
Balances Without Adoption of Topic 606 | Accounting Standards Update 2014-09 | ||
Revenues: | ||
Net revenue - commercial product sales | 3,991 | |
Expenses: | ||
Cost of goods sold | 4,052 | |
Net loss | $ (29,840) |
Schedule of Adoption of New R39
Schedule of Adoption of New Revenue Guidance Impact on Condensed Consolidated Statement of Cash Flows (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (30,385) | $ (16,324) |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | 1,128 | (136) |
Deferred costs from commercial product sales | 163 | |
Accrued expenses and other current liabilities | 2,675 | 1,077 |
Deferred revenue, net | (1,575) | |
Cash (used in) provided by operating activities | (21,650) | $ 8,507 |
Adjustments | Accounting Standards Update 2014-09 | ||
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | 545 | |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (18) | |
Deferred costs from commercial product sales | 44 | |
Accrued expenses and other current liabilities | 171 | |
Deferred revenue, net | (740) | |
Cash (used in) provided by operating activities | 2 | |
Balances Without Adoption of Topic 606 | Accounting Standards Update 2014-09 | ||
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | (29,840) | |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | 1,110 | |
Deferred costs from commercial product sales | 44 | |
Accrued expenses and other current liabilities | 2,846 | |
Deferred revenue, net | (740) | |
Cash (used in) provided by operating activities | $ (21,648) |
Schedule of Accounts Receivable
Schedule of Accounts Receivable, Net (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Receivables [Abstract] | ||
Accounts receivable, gross | $ 2,019 | $ 2,842 |
Wholesaler distribution fees and prompt pay discounts | (340) | (53) |
Reserve for returns | (129) | |
Accounts receivable, net | $ 1,550 | $ 2,789 |
Accounts Receivable - Additiona
Accounts Receivable - Additional Information (Detail) - Distributor | 3 Months Ended | ||
Mar. 31, 2018 | Mar. 31, 2017 | Dec. 31, 2017 | |
Receivables [Abstract] | |||
Number of wholesale distributors | 3 | 3 | |
Percentage of accounts receivable from major wholesale distributors | 90.00% | 93.00% |
Components of Inventories (Deta
Components of Inventories (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 772 | $ 572 |
Work-in-process | 2,519 | 1,273 |
Finished goods | 600 | 812 |
Total inventory | $ 3,891 | $ 2,657 |
Inventories - Additional Inform
Inventories - Additional Information (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2018USD ($) | |
Inventory Disclosure [Abstract] | |
Inventory write-off | $ 602 |
Property and Equipment, Net (De
Property and Equipment, Net (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Dec. 31, 2017 | |
Property Plant And Equipment [Line Items] | ||
Property and equipment - gross | $ 127,424 | $ 127,874 |
Less accumulated depreciation | (100,943) | (100,952) |
Total property and equipment, net | 26,481 | 26,922 |
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 | $ 62,681 | 62,681 |
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 | $ 3,106 | 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 | $ 8,416 | $ 8,416 |
Depreciation Expense Related to
Depreciation Expense Related to Property and Equipment (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Property Plant And Equipment [Abstract] | ||
Depreciation Expense | $ 441 | $ 446 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) $ in Millions | Feb. 17, 2017 | Jan. 06, 2017 | Mar. 31, 2018 |
Furniture, fixtures and office equipment | |||
Depreciation And Other Amortization Expenses [Line Items] | |||
Amount of divestiture of long-lived | $ 0.4 | ||
Land, Buildings and Improvements | California | |||
Depreciation And Other Amortization Expenses [Line Items] | |||
Amount of divestiture of long-lived | $ 17.3 | ||
Cash received from property, plant and equipment | $ 17.3 | ||
Net cash received from property, plant and equipment | 16.7 | ||
Payments for commissions and other fees | $ 0.6 |
Accrued Expenses and Other Cu47
Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Accrued Expenses And Other Current Liabilities [Abstract] | ||
Salary and related expenses | $ 10,474 | $ 7,260 |
Current portion of milestone rights liability | 1,643 | 1,643 |
Professional fees | 872 | 1,007 |
Discounts and allowances for commercial product sales | 766 | 873 |
Sales and marketing services | 625 | 147 |
Restructuring | 362 | 362 |
Accrued interest | 226 | 567 |
Other | 962 | 590 |
Accrued expenses and other current liabilities | $ 15,930 | $ 12,449 |
Accrued Expenses and Other Cu48
Accrued Expenses and Other Current Liabilities - Additional Information (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Accrued Expenses And Other Current Liabilities [Line Items] | ||
Accrued salary and related expenses | $ 10,474 | $ 7,260 |
Selling, General and Administrative Costs | ||
Accrued Expenses And Other Current Liabilities [Line Items] | ||
Accrued salary and related expenses | $ 800 |
Schedule of Related Party Debt
Schedule of Related Party Debt (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Related Party Transaction [Line Items] | ||
Principal amount | $ 140,200 | |
Net carrying amount | 72,247 | $ 79,666 |
Related Party Debt | ||
Related Party Transaction [Line Items] | ||
Principal amount | 71,506 | 79,666 |
Unamortized premium | 815 | |
Unaccreted debt issuance costs | (74) | |
Net carrying amount | $ 72,247 | $ 79,666 |
Related-Party Arrangements - Ad
Related-Party Arrangements - Additional Information (Detail) | Mar. 11, 2018USD ($)$ / sharesshares | Oct. 23, 2017shares | Oct. 10, 2017$ / sharesshares | May 31, 2015USD ($)ft² | Oct. 31, 2013USD ($) | Oct. 31, 2007USD ($) | Mar. 31, 2018USD ($)$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares | Jun. 30, 2017USD ($) |
Related Party Transaction [Line Items] | |||||||||
Principal amount | $ 140,200,000 | ||||||||
Loss on extinguishment of debt | $ (825,000) | ||||||||
Common stock, shares issued | shares | 126,013,051 | 119,053,414 | |||||||
Common stock, par value | $ / shares | $ 0.01 | $ 0.01 | |||||||
Amount available for future borrowings | $ 0 | $ 0 | |||||||
Common Stock | |||||||||
Related Party Transaction [Line Items] | |||||||||
Number of shares sold in underwritten public offering | shares | 973,236 | ||||||||
Charitable Foundation | Common Stock | Director | |||||||||
Related Party Transaction [Line Items] | |||||||||
Number of shares sold in underwritten public offering | shares | 166,600 | ||||||||
Exchange price per share | $ / shares | $ 6 | ||||||||
The Mann Group LLC | |||||||||
Related Party Transaction [Line Items] | |||||||||
Loan agreement with related party | $ 370,000,000 | $ 350,000,000 | |||||||
Loss on extinguishment of debt | 800,000 | ||||||||
Unamortized premium | 800,000 | ||||||||
Debt issuance costs | $ 100,000 | ||||||||
The Mann Group LLC | Amended Agreement | |||||||||
Related Party Transaction [Line Items] | |||||||||
Maturity date | Jan. 5, 2020 | ||||||||
The Mann Group LLC | Loan Arrangement | |||||||||
Related Party Transaction [Line Items] | |||||||||
Accrued interest of related party debt | $ 3,500,000 | 2,300,000 | $ 10,700,000 | ||||||
Available amount of credit facility under covenant restrictions | $ 19,400,000 | ||||||||
Common stock, shares issued | shares | 3,000,000 | ||||||||
Common stock, par value | $ / shares | $ 2.72 | ||||||||
Principal balance cancelled amount | $ 8,200,000 | ||||||||
Fixed borrowing rate | 5.84% | ||||||||
Related party transaction prepayment period | 90 days | ||||||||
Aggregate principal amount cancelled | $ 113,200,000 | ||||||||
The Mann Group LLC | Loan Arrangement | Maximum | |||||||||
Related Party Transaction [Line Items] | |||||||||
Amount prepaid for cancellation of indebtedness | $ 200,000,000 | ||||||||
The Mann Group LLC | Loan Arrangement | Minimum | |||||||||
Related Party Transaction [Line Items] | |||||||||
Number of months advances outstanding | 12 months | ||||||||
The Mann Group LLC | Amended and Restated Loan Arrangement | |||||||||
Related Party Transaction [Line Items] | |||||||||
Maturity date | Jul. 1, 2021 | ||||||||
Principal amount | $ 71,500,000 | ||||||||
No of convertible shares | 250 | ||||||||
Principal amount per share | $ / shares | $ 1,000 | ||||||||
Conversion price of shares | $ / shares | $ 4 | ||||||||
Related Party Debt | |||||||||
Related Party Transaction [Line Items] | |||||||||
Principal amount | $ 71,506,000 | $ 79,666,000 | |||||||
Unamortized premium | 815,000 | ||||||||
Debt issuance costs | $ 74,000 | ||||||||
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] | |||||||||
Area of office space leased | ft² | 12,500 | ||||||||
Lease expiration period | 2017-04 | ||||||||
Amount of leases renewed per month | $ 20,000 | ||||||||
Lease expiration date | Aug. 31, 2017 | ||||||||
Lease payments | $ 62,000 |
Schedule of Interest Expense on
Schedule of Interest Expense on Note Payable to Related Party (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Related Party Transactions [Abstract] | ||
Interest expense on note payable to related party | $ 1,122 | $ 714 |
Schedule of Amortization of Pre
Schedule of Amortization of Premium and Accretion of Debt Issuance Costs Related to Related Party Notes (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Related Party Transaction [Line Items] | ||
Amortization of debt premium | $ 310 | $ 447 |
Related Party Notes | ||
Related Party Transaction [Line Items] | ||
Amortization of debt premium | 10 | |
Accretion expense - debt issuance cost | $ 2 |
Summary of Borrowings (Detail)
Summary of Borrowings (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 | Oct. 23, 2017 |
Debt Instrument [Line Items] | |||
Principal amount | $ 140,200 | ||
Note payable to related party - net carrying amount | 72,247 | $ 79,666 | |
Total debt - net carrying amount | 140,269 | 156,822 | |
Tranche B Notes | |||
Debt Instrument [Line Items] | |||
Principal amount | 10,000 | ||
Senior convertible notes due December 31, 2019 | |||
Debt Instrument [Line Items] | |||
Principal amount | 35,000 | ||
Senior convertible notes due December 31, 2019 | Tranche B Notes | |||
Debt Instrument [Line Items] | |||
Principal amount | 45,000 | 54,407 | |
Unamortized debt issuance costs and debt discount | (1,346) | (1,662) | |
Net carrying amount | 43,654 | 52,745 | |
5.75% Senior convertible notes due October 23, 2021 | |||
Debt Instrument [Line Items] | |||
Principal amount | 23,690 | 23,690 | $ 23,700 |
Unamortized premium | 678 | 721 | |
Net carrying amount | $ 24,368 | $ 24,411 |
Borrowings - Additional Informa
Borrowings - Additional Information (Detail) | Mar. 12, 2018USD ($)shares | Mar. 06, 2018USD ($)d$ / sharesshares | Jan. 18, 2018USD ($)d$ / sharesshares | Jan. 15, 2018USD ($) | Nov. 06, 2017USD ($)$ / sharesshares | Oct. 23, 2017USD ($)d$ / sharesshares | Jun. 29, 2017USD ($)$ / sharesshares | Apr. 18, 2017USD ($)$ / sharesshares | Feb. 28, 2015USD ($) | Mar. 31, 2018USD ($)$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares | Mar. 31, 2017USD ($) | Mar. 09, 2018$ / shares | Sep. 30, 2017USD ($) | Jul. 01, 2013USD ($) |
Debt Instrument [Line Items] | |||||||||||||||
Principal amount | $ 140,200,000 | ||||||||||||||
Loss on extinguishment of debt | 825,000 | ||||||||||||||
Cash and cash equivalents | $ 26,706,000 | $ 43,946,000 | |||||||||||||
Common stock, shares issued | shares | 126,013,051 | 119,053,414 | |||||||||||||
Common stock, par value | $ / shares | $ 0.01 | $ 0.01 | |||||||||||||
Other liabilities | $ 156,600,000 | $ 93,500,000 | |||||||||||||
Interest expense on notes | $ 5,800,000 | 1,794,000 | $ 2,706,000 | ||||||||||||
Required payment pursuant to the terms of the Milestone Agreement | $ 10,000,000 | ||||||||||||||
Common Stock | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Number of shares sold in underwritten public offering | shares | 973,236 | ||||||||||||||
Deerfield | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Principal amount | 39,400,000 | ||||||||||||||
Tranche B Notes | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Principal amount | $ 10,000,000 | ||||||||||||||
Senior notes, effective interest rate | 8.75% | ||||||||||||||
Tranche B Notes | Deerfield | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Principal amount | 15,000,000 | ||||||||||||||
Tranche B Exchange Shares | Deerfield | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Senior notes, effective interest rate | 8.75% | ||||||||||||||
Conversion of notes to common shares, value | $ 5,000,000 | ||||||||||||||
Conversion Option, shares | shares | 1,838,236 | ||||||||||||||
Exchange price per share | $ / shares | $ 2.72 | ||||||||||||||
Milestone Rights Liability | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Other liabilities | $ 17,800,000 | 19,100,000 | |||||||||||||
Milestone Rights Liability | Deerfield | Maximum | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Contingent liability for milestone payments | 90,000,000 | $ 90,000,000 | |||||||||||||
5.75% Senior convertible notes due October 23, 2021 | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Principal amount | $ 23,700,000 | $ 23,690,000 | 23,690,000 | ||||||||||||
Senior notes, effective interest rate | 5.75% | 5.75% | |||||||||||||
Maturity date | Oct. 23, 2021 | ||||||||||||||
Conversion price of shares | $ / shares | $ 5.15 | ||||||||||||||
Other liabilities | $ 19,900,000 | 19,800,000 | |||||||||||||
Unamortized premium | 678,000 | 721,000 | |||||||||||||
5.75% Senior convertible notes due October 23, 2021 | Maximum | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Common stock, shares issued | shares | 13,648,300 | ||||||||||||||
Senior convertible notes due December 31, 2019 | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Principal amount | $ 35,000,000 | ||||||||||||||
Senior notes, effective interest rate | 9.75% | ||||||||||||||
Conversion of notes to common shares, value | $ 1,300,000 | ||||||||||||||
Exchange price per share | $ / shares | $ 2.83 | $ 1.45 | $ 1.22 | ||||||||||||
Loss on extinguishment of debt | $ 500,000 | ||||||||||||||
Cash repayment | $ 4,000,000 | ||||||||||||||
Debt extinguishment amount | 5,000,000 | ||||||||||||||
Debt discount and issuance costs | 300,000 | ||||||||||||||
Number of trading days | d | 3 | ||||||||||||||
Senior convertible notes due December 31, 2019 | Common Stock | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Conversion Option, shares | shares | 441,618 | ||||||||||||||
Senior convertible notes due December 31, 2019 | Deerfield | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Senior notes, effective interest rate | 9.75% | ||||||||||||||
Accrued expenses | $ 1,600,000 | ||||||||||||||
Other current liabilities | 1,600,000 | ||||||||||||||
Other liabilities | 8,900,000 | ||||||||||||||
Senior convertible notes due December 31, 2019 | Deerfield | Facility Agreement Third Amendment | |||||||||||||||
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 and cash equivalents | $ 10,000,000 | ||||||||||||||
Senior convertible notes due December 31, 2019 | Deerfield | Minimum | Facility Agreement Third Amendment | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Cash and cash equivalents | $ 25,000,000 | $ 10,000,000 | |||||||||||||
Senior convertible notes due December 31, 2019 | Tranche B Notes | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Principal amount | $ 45,000,000 | 54,407,000 | |||||||||||||
Loss on extinguishment of debt | 300,000 | ||||||||||||||
Senior convertible notes due December 31, 2019 | Tranche B Notes | Deerfield | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Senior notes, effective interest rate | 8.75% | ||||||||||||||
Cash repayment of senior notes under exchange agreement | 4,000,000 | ||||||||||||||
Conversion of notes to common shares, value | $ 1,000,000 | ||||||||||||||
Senior convertible notes due December 31, 2019 | Tranche B Exchange Shares | Deerfield | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Conversion Option, shares | shares | 869,565 | ||||||||||||||
Exchange price per share | $ / shares | $ 1.15 | ||||||||||||||
Senior convertible notes due December 31, 2019 | Tranche 1 Notes | Deerfield | |||||||||||||||
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 | Milestone Rights Liability | Deerfield | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Long term liability | $ 7,200,000 | 8,900,000 | |||||||||||||
Senior convertible notes due December 31, 2019 | Notes Due and Payable On July 2018 | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Principal amount | 15,000,000 | ||||||||||||||
Senior convertible notes due December 31, 2019 | Notes Due and Payable On July 2019 | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Principal amount | 15,000,000 | ||||||||||||||
Senior convertible notes due December 31, 2019 | Notes Due and Payable On December 2019 | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Principal amount | 5,000,000 | ||||||||||||||
Senior convertible notes due December 31, 2019 | Fourth Amendment to Facility Agreement | Tranche B Exchange Shares | Deerfield | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Conversion of notes to common shares, value | $ 5,600,000 | ||||||||||||||
Conversion Option, shares | shares | 1,720,846 | ||||||||||||||
Conversion price of shares | $ / shares | $ 3.25 | ||||||||||||||
Senior convertible notes due December 31, 2019 | Fifth Amendment to Facility Agreement | Deerfield | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Deferred payment of credit facility principal amount | $ 4,400,000 | ||||||||||||||
Senior convertible notes due December 31, 2019 | Sixth Amendment to Facility Agreement | Deerfield | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Conversion of notes to common shares, value | $ 3,200,000 | ||||||||||||||
Exchange price per share | $ / shares | $ 2.49 | ||||||||||||||
Deferred payment of credit facility principal amount | $ 1,300,000 | ||||||||||||||
Common stock, shares issued | shares | 1,267,972 | ||||||||||||||
Common stock, par value | $ / shares | $ 0.01 | ||||||||||||||
Senior convertible notes due December 31, 2019 | Sixth Amendment to Facility Agreement | Tranche B Exchange Shares | Deerfield | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Number of trading days | d | 3 | ||||||||||||||
Conversion price of shares | $ / shares | $ 2.75 | ||||||||||||||
Senior convertible notes due December 31, 2019 | Sixth Amendment to Facility Agreement | Tranche B Exchange Shares | Deerfield | Common Stock | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Number of shares sold in underwritten public offering | shares | 10,000,000 | ||||||||||||||
Notes Due and Payable On May 2019 | Tranche B Notes | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Principal amount | 5,000,000 | ||||||||||||||
Notes Due and Payable On December 2019 | Tranche B Notes | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Principal amount | 5,000,000 | ||||||||||||||
2019 Notes and Tranche B Notes | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Other liabilities | $ 50,100,000 | 54,600,000 | |||||||||||||
2019 Notes and Tranche B Notes | Fourth Amendment to Facility Agreement | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Deferred payment of credit facility principal amount | $ 10,000,000 | ||||||||||||||
2019 Notes and Tranche B Notes | Fourth Amendment to Facility Agreement | Tranche B Exchange Shares | Deerfield | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Number of trading days | d | 3 | ||||||||||||||
Conversion price of shares | $ / shares | $ 3.25 | ||||||||||||||
2019 Notes and Tranche B Notes | Fourth Amendment to Facility Agreement | Tranche B Exchange Shares | Deerfield | Maximum | Common Stock | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Number of shares sold in underwritten public offering | shares | 4,000,000 | ||||||||||||||
5.75% Senior convertible notes due August 15, 2018 | |||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||
Principal amount | $ 27,700,000 | ||||||||||||||
Senior notes, effective interest rate | 5.75% | ||||||||||||||
Loss on extinguishment of debt | 800,000 | ||||||||||||||
Number of trading days | d | 10 | ||||||||||||||
Conversion price of shares | $ / shares | $ 34 | ||||||||||||||
Debt issuance costs | 300,000 | ||||||||||||||
Unamortized premium | $ 200,000 | ||||||||||||||
No of convertible shares | 194.1748 | ||||||||||||||
Principal amount per share | $ / shares | $ 1,000 | ||||||||||||||
Percentage of repurchase price | 100.00% | ||||||||||||||
Debt Instrument, redemption description | The Company may elect at its option to cause all or any portion of the 2021 notes to be mandatorily converted in whole or part at any time prior to the close of business on the business day immediately preceding the maturity date, if the last reported sale price of its common stock exceeds 120% of the conversion price then in effect for at least 10 trading days in any 20 consecutive trading day period, ending within five business days prior to the date of the mandatory conversion notice. The redemption price is equal the sum of 100% of the principal amount of the 2021 notes to be redeemed, plus accrued and unpaid interest. | ||||||||||||||
Percentage of conversion price equaling stock price | 120.00% | ||||||||||||||
Consecutive trading days | 20 days | ||||||||||||||
Debt Issuance Cost | $ 800,000 |
Accretion of Debt Issuance Cost
Accretion of Debt Issuance Cost and Debt Discount (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Debt Disclosure [Abstract] | ||
Accretion expense - debt issuance cost | $ 6 | $ 9 |
Accretion expense - debt discount | $ 310 | $ 447 |
Schedule of Amortization of P56
Schedule of Amortization of Premium and Accretion of Debt Issuance Costs (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Debt Instrument [Line Items] | ||
Amortization of debt premium | $ 310 | $ 447 |
5.75% Senior convertible notes due August 15, 2018 and 5.75% Senior convertible notes due October 23, 2021 | ||
Debt Instrument [Line Items] | ||
Amortization of debt premium | $ 43 | 59 |
Accretion expense - debt issuance cost | $ 66 |
Collaboration Arrangements - Ad
Collaboration Arrangements - Additional Information (Detail) - USD ($) $ in Millions | Dec. 30, 2016 | Jan. 31, 2017 | Mar. 31, 2018 | Dec. 31, 2016 |
Sanofi-Aventis Deutschland GmbH | Put Option | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Payment for insulin put option | $ 30.6 | |||
Receptor | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Nonrefundable option exercise and license fee | $ 1 | |||
Deferred revenue - nonrefundable license fee | $ 1 | |||
Deferred revenue recognition period | 4 years | |||
Deferred payments from collaboration | $ 0.7 | |||
Receptor | Current Liabilities | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Deferred payments from collaboration | $ 0.3 |
Sale of Intellectual Property -
Sale of Intellectual Property - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | |
Finite-Lived Intangible Assets [Line Items] | |||
Revenue - other | $ 1,750 | ||
Intellectual property | |||
Finite-Lived Intangible Assets [Line Items] | |||
Proceeds from royalties | $ 600 | ||
Revenue - other | $ 600 |
Fair Value of Financial Instr59
Fair Value of Financial Instruments - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2018 | Dec. 31, 2017 | |
Fair Value of Financial Instruments [Line Items] | ||
Restricted cash | $ 527,000 | $ 4,409,000 |
Note payable, percentage of interest rate change | 1.00% | |
Fair value of note payable to related party, description | The fair value measurement of the note payable is sensitive to the change in interest rate. If the interest rate changes by approximately 1%, the fair value of the note payable would change by $1 million or 1.4%. | |
Change in fair value of note payable value due to change in interest rate percentage | $ 1,000,000 | |
Change in fair value of note payable percentage due to change in interest rate percentage | 1.40% | |
Fair value of the liability, percentage decrease | 8.00% | |
Minimum | ||
Fair Value of Financial Instruments [Line Items] | ||
Probabilities of meeting the milestones, amount | $ 50,000,000 | |
Probabilities of meeting the milestones, percentage decrease | 5.00% | |
Fair value of the liability, percentage decrease | 13.00% | |
Maximum | ||
Fair Value of Financial Instruments [Line Items] | ||
Probabilities of meeting the milestones, amount | $ 200,000,000 | |
Probabilities of meeting the milestones, percentage decrease | 10.00% | |
Fair value of the liability, percentage decrease | 25.00% | |
Money Market Funds | ||
Fair Value of Financial Instruments [Line Items] | ||
Cash equivalents | $ 23,400,000 | 41,000,000 |
Restricted cash | $ 500,000 | $ 4,400,000 |
Fair Value of Financial Instr60
Fair Value of Financial Instruments (Detail) - USD ($) $ in Millions | Mar. 31, 2018 | Dec. 31, 2017 |
Financial liabilities: | ||
Financial liabilities fair value | $ 156.6 | $ 93.5 |
Milestone Rights Liability | ||
Financial liabilities: | ||
Financial liabilities fair value | 17.8 | 19.1 |
Carrying Value | ||
Financial liabilities: | ||
Financial liabilities fair value | 149.2 | 86 |
Carrying Value | Milestone Rights Liability | ||
Financial liabilities: | ||
Financial liabilities fair value | 8.9 | 8.9 |
Estimate of Fair Value Measurement | Fair Value, Inputs, Level 3 | ||
Financial liabilities: | ||
Financial liabilities fair value | 156.6 | 93.5 |
Estimate of Fair Value Measurement | Milestone Rights Liability | Fair Value, Inputs, Level 3 | ||
Financial liabilities: | ||
Financial liabilities fair value | 17.8 | 19.1 |
5.75% Senior convertible notes due October 23, 2021 | ||
Financial liabilities: | ||
Financial liabilities fair value | 19.9 | 19.8 |
5.75% Senior convertible notes due October 23, 2021 | Carrying Value | ||
Financial liabilities: | ||
Financial liabilities fair value | 24.4 | 24.4 |
5.75% Senior convertible notes due October 23, 2021 | Estimate of Fair Value Measurement | Fair Value, Inputs, Level 3 | ||
Financial liabilities: | ||
Financial liabilities fair value | 19.9 | 19.8 |
Facility Financing Obligation | ||
Financial liabilities: | ||
Financial liabilities fair value | 50.1 | 54.6 |
Facility Financing Obligation | Carrying Value | ||
Financial liabilities: | ||
Financial liabilities fair value | 43.7 | 52.7 |
Facility Financing Obligation | Estimate of Fair Value Measurement | Fair Value, Inputs, Level 3 | ||
Financial liabilities: | ||
Financial liabilities fair value | 50.1 | $ 54.6 |
Note Payable to Related Party | ||
Financial liabilities: | ||
Financial liabilities fair value | 68.8 | |
Note Payable to Related Party | Carrying Value | ||
Financial liabilities: | ||
Financial liabilities fair value | 72.2 | |
Note Payable to Related Party | Estimate of Fair Value Measurement | Fair Value, Inputs, Level 3 | ||
Financial liabilities: | ||
Financial liabilities fair value | $ 68.8 |
Stock Based Compensation Expens
Stock Based Compensation Expense Recognized in Accompanying Consolidated Statements of Operations (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||
Stock-based compensation | $ 1,943 | $ 1,267 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2018 | Mar. 31, 2017 | |
Stock Options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period | 4 years | |
Aggregate number of shares granted to awards, share-based compensation arrangements | 456,720 | |
Weighted average exercise price of the stock options granted | $ 2.76 | |
Fair value of stock granted, share-based compensation arrangements | $ 1,000,000 | |
Weighted average grant date fair value of the stock options granted | $ 2.10 | |
Restricted Stock Units | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of restricted stock units issued | 57,400 | |
Vesting period | 4 years | |
Fair value of Restricted stock options granted | $ 158,424 | |
Weighted average grant date fair value of the stock options granted | $ 2.76 | |
Unrecognized compensation expense related to non-option | $ 2,800,000 | |
Options vest over vesting period | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation expense related to options | 3,400,000 | |
Performance-based Stock Options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation expense related to options | 2,400,000 | |
Compensation cost | $ 1,000,000 | $ 100,000 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) € in Millions | Apr. 02, 2018EUR (€) | Nov. 29, 2017USD ($) | May 05, 2017USD ($) | Mar. 31, 2018USD ($)Vehicle | Mar. 31, 2018EUR (€)Vehicle | Oct. 01, 2018USD ($) | Mar. 31, 2018EUR (€) | Mar. 08, 2018USD ($) | Dec. 31, 2017USD ($) | Jul. 01, 2013USD ($) |
Commitments And Contingencies [Line Items] | ||||||||||
Purchase commitment amount under Insulin Supply Agreement | € | € 90.3 | |||||||||
Purchase obligation included in accounts payable | $ 1,600,000 | |||||||||
Supply Agreement expiration period | Dec. 31, 2023 | Dec. 31, 2023 | ||||||||
Supply Agreement renewal period | 2 years | 2 years | ||||||||
Annual purchase requirement amount for current year | € | € 8.9 | |||||||||
Operating lease rent expenses | $ 100,000 | |||||||||
Lease Agreement with Enterprise | Vehicle Leases | ||||||||||
Commitments And Contingencies [Line Items] | ||||||||||
Number of vehicle leases | Vehicle | 100 | 100 | ||||||||
Operating lease rent expenses | $ 54,000 | |||||||||
Lease commencement period | 2018-05 | 2018-05 | ||||||||
Lease expiration period | 48 months | 48 months | ||||||||
Supply Commitment | ||||||||||
Commitments And Contingencies [Line Items] | ||||||||||
Purchase commitment obligation | $ 300,000 | |||||||||
Foreign Currency Hedging Transaction | Subsequent Event | ||||||||||
Commitments And Contingencies [Line Items] | ||||||||||
Annual purchase requirement amount for current year | € | € 8.9 | |||||||||
Foreign currency hedging transaction renewable period | 90 days | |||||||||
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 | |||||||||
Standby Letter of Credit | Vehicle Leases | ||||||||||
Commitments And Contingencies [Line Items] | ||||||||||
Maximum borrowing capacity | $ 500,000 | |||||||||
Collateralized amount under letter of credit | $ 500,000 | |||||||||
Amount drawn down on letter of credit | 0 | |||||||||
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 | ||||||||||
Commitments And Contingencies [Line Items] | ||||||||||
Operating lease rent expenses | $ 35,969 | $ 40,951 | ||||||||
Percentage of annual increase in lease payment | 3.00% | 3.00% | ||||||||
Lease expiration date | Jan. 31, 2023 | Jan. 31, 2023 | ||||||||
Lease renewal option | 5 years | 5 years | ||||||||
Maximum reimbursable amount for tenant improvements | $ 56,325 |
Annual Purchase Requirements un
Annual Purchase Requirements under Contract (Detail) € in Millions | Mar. 31, 2018EUR (€) |
Annual Purchase Requirements under Contract | |
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) | Mar. 31, 2018USD ($) |
Leases [Abstract] | |
2,018 | $ 522,000 |
2,019 | 947,000 |
2,020 | 976,000 |
2,021 | 1,005,000 |
2,022 | 1,035,000 |
Thereafter | 88,000 |
Total | $ 4,573,000 |
Income Taxes -Additional Inform
Income Taxes -Additional Information (Detail) $ in Millions | 3 Months Ended |
Mar. 31, 2018USD ($) | |
Income Tax Disclosure [Abstract] | |
Decrease of deferred tax assets | $ 301 |
Decrease in valuation allowance | 301 |
Additional income tax expense or benefit | 0 |
Provisional amount recorded related to mandatory deemed repatriation of foreign earnings | $ 0 |
Restructuring Charges - Additio
Restructuring Charges - Additional information (Detail) - USD ($) $ in Thousands | Mar. 31, 2018 | Dec. 31, 2017 |
Restructuring Cost and Reserve [Line Items] | ||
Restructuring | $ 362 | $ 362 |
Accrued Expenses and Other Current Liabilities | ||
Restructuring Cost and Reserve [Line Items] | ||
Restructuring | $ 400 | $ 400 |
Reconciliation of Beginning and
Reconciliation of Beginning and Ending Liability Balances for Restructuring Charges (Detail) $ in Thousands | Mar. 31, 2018USD ($) |
Restructuring Cost and Reserve [Line Items] | |
Accrual - Beginning balance | $ 362 |
Accrual - Ending balance | 362 |
Twenty Fifteen Restructuring Plan | |
Restructuring Cost and Reserve [Line Items] | |
Accrual - Beginning balance | 362 |
Accrual - Ending balance | $ 362 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | May 08, 2018 | Apr. 05, 2018 | Oct. 23, 2017 | Mar. 31, 2018 |
Subsequent Event [Line Items] | ||||
Amount of net proceeds from issuance of securities | $ 634 | |||
Common Stock | ||||
Subsequent Event [Line Items] | ||||
Number of shares sold in underwritten public offering | 973,236 | |||
Subsequent Event | Cipla Ltd | ||||
Subsequent Event [Line Items] | ||||
Marketing and distribution agreement date | May 8, 2018 | |||
Upfront payment received | $ 2,200 | |||
Subsequent Event | Purchase Agreements | ||||
Subsequent Event [Line Items] | ||||
Stock purchase agreements date | Apr. 5, 2018 | |||
Subsequent Event | Purchase Agreements | Common Stock | ||||
Subsequent Event [Line Items] | ||||
Number of shares sold in underwritten public offering | 14,000,000 | |||
Amount of net proceeds from issuance of securities | $ 26,300 | |||
Exchange price per share | $ 2 | |||
Subsequent Event | Purchase Agreements | Warrants | ||||
Subsequent Event [Line Items] | ||||
Warrants to purchase of common stock | 14,000,000 | |||
Exercise price of warrants | $ 2.38 |