Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Feb. 26, 2018 | Jun. 30, 2017 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2017 | ||
Document Fiscal Year Focus | 2,017 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | VLRX | ||
Entity Registrant Name | VALERITAS HOLDINGS INC. | ||
Entity Central Index Key | 1,619,250 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | Yes | ||
Entity Filer Category | Smaller Reporting Company | ||
Entity Common Stock, Shares Outstanding | 7,007,782 | ||
Entity Public Float | $ 10,999,881 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 25,961 | $ 9,866 |
Accounts receivable, net | 3,991 | 3,462 |
Other receivables | 242 | 173 |
Inventories, net | 8,105 | 9,384 |
Deferred cost of goods sold | 539 | 690 |
Prepaid expense and other current assets | 634 | 569 |
Total current assets | 39,472 | 24,144 |
Property and equipment, net | 5,469 | 10,219 |
Other assets | 148 | 153 |
Total assets | 45,089 | 34,516 |
Current liabilities: | ||
Accounts payable | 5,644 | 4,591 |
Accrued expense and other current liabilities | 5,798 | 5,532 |
Deferred revenue | 1,638 | 1,623 |
Total current liabilities | 13,080 | 11,746 |
Long-term debt, related parties (net of issuance costs of $125 and $214, respectively). | 36,009 | 58,978 |
Other long-term liabilities | 58 | 292 |
Total liabilities | 49,147 | 71,016 |
Commitments and contingencies (note 16) | ||
Stockholders’ deficit | ||
Convertible preferred stock, $0.001 par value; 50,000,000 authorized at December 31, 2017; 2,750,000 and 0 shares issued and outstanding, respectively (aggregate liquidation value of $29,211 and $0, respectively). | 3 | 0 |
Common stock, $0.001 par value, 300,000,000 shares authorized; 7,007,782 and 1,590,948 shares issued and outstanding, respectively | 7 | 2 |
Additional paid-in capital | 469,877 | 387,737 |
Accumulated deficit | (473,921) | (424,239) |
Treasury stock, at cost (7,854 and 0 shares, respectively) | (24) | 0 |
Total stockholders’ deficit | (4,058) | (36,500) |
Total liabilities and stockholders’ deficit | $ 45,089 | $ 34,516 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Statement of Financial Position [Abstract] | ||
Issuance costs | $ 125,000 | $ 214,000 |
Preferred Stock, par value (usd per share) | $ 0.001 | $ 0.001 |
Preferred Stock, shares authorized | 50,000,000 | 2,750,000 |
Preferred Stock, shares issued | 0 | 0 |
Preferred Stock, shares outstanding | 0 | 0 |
Aggregate liquidation value | $ 29,211,000 | $ 0 |
Common stock, par value (usd per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued | 7,007,782 | 1,590,948 |
Common stock, shares outstanding | 7,007,782 | 1,590,948 |
Treasury stock, shares | 7,854 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Statement of Comprehensive Income [Abstract] | ||
Revenue, net | $ 20,245 | $ 19,550 |
Cost of goods sold | 12,080 | 12,606 |
Gross margin | 8,165 | 6,944 |
Operating expense: | ||
Research and development | 7,126 | 4,842 |
Selling, general and administrative | 42,596 | 33,481 |
Restructuring costs | 0 | 2,394 |
Long-lived asset impairment costs | 3,711 | 0 |
Total operating expense | 53,433 | 40,717 |
Operating loss | (45,268) | (33,773) |
Other income (expense), net: | ||
Interest expense, net | (4,263) | (12,151) |
Change in fair value of derivative liabilities | 221 | (549) |
Other income | 9 | 106 |
Total other income (expense), net | (4,033) | (12,594) |
Loss before income taxes | (49,301) | (46,367) |
Income tax expense | 0 | 0 |
Net loss | (49,301) | (46,367) |
Preferred stock dividend | (1,711) | 0 |
Net loss attributable to common stockholders | $ (51,012) | $ (46,367) |
Net loss per share of common share outstanding - basic and diluted (usd per share) | $ (8.94) | $ (39.06) |
Weighted average common shares outstanding — basic and diluted | 5,708,577 | 1,187,104 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Deficit - USD ($) $ in Thousands | Total | Preferred Stock | Common Stock | Treasury Stock | Additional Paid-in capital | Accumulated Deficit | Private placement offering | Private placement offeringCommon Stock | Private placement offeringAdditional Paid-in capital | Related party | Related partyCommon Stock | Related partyAdditional Paid-in capital |
Beginning balance at Dec. 31, 2015 | $ (53,345) | $ 0 | $ 0 | $ 0 | $ 324,527 | $ (377,872) | ||||||
Beginning balance, shares at Dec. 31, 2015 | 0 | 203,967 | 0 | |||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||
Share-based compensation expense | 3,499 | 3,499 | ||||||||||
Issuance of common stock as a result of the exercise of warrants by related party | $ 8,933 | $ 8,933 | ||||||||||
Issuance of common stock as a result of the exercise of warrants by related party, shares | 175,934 | |||||||||||
Issuance of common stock, net of expense | $ 23,698 | $ 1 | $ 23,697 | 5,819 | 5,819 | |||||||
Issuance of common stock, shares | 634,858 | 138,826 | ||||||||||
Conversion of accrued interest to Common Stock by related parties | $ 17,934 | $ 1 | $ 17,933 | |||||||||
Conversion of accrued interest to Common Stock by related parties, shares | 306,270 | |||||||||||
Recapitalization for reverse merger, shares | 125,000 | |||||||||||
Shares issued for restricted stock compensation | 293 | 293 | ||||||||||
Shares issued for restricted stock compensation, shares | 6,093 | |||||||||||
Cancellation of warrants previously classified as derivative liabilities | 3,036 | 3,036 | ||||||||||
Treasury Shares | 0 | |||||||||||
Net loss | (46,367) | (46,367) | ||||||||||
Ending balances at Dec. 31, 2016 | (36,500) | $ 0 | $ 2 | $ 0 | 387,737 | (424,239) | ||||||
Ending balances, shares at Dec. 31, 2016 | 0 | 1,590,948 | 0 | |||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||
Share-based compensation expense | 5,510 | 5,510 | ||||||||||
Issuance of common stock, net of expense | 48,786 | $ 5 | 48,781 | |||||||||
Issuance of common stock, shares | 5,250,000 | |||||||||||
Issuance of common stock for compensation | 73 | 73 | ||||||||||
Issuance of common stock for compensation, shares | 2,030 | |||||||||||
Issuance of preferred stock upon conversion of debt, net of discount | 27,398 | $ 3 | 27,395 | |||||||||
Issuance of preferred stock upon conversion of debt, net of discount, shares | 2,750,000 | |||||||||||
Commitment fee for Purchase Agreement | 0 | |||||||||||
Commitment fee for Purchase Agreement, shares | 125,000 | |||||||||||
Restricted shares vested, shares | 47,658 | |||||||||||
Cancellation of warrants previously classified as derivative liabilities | 0 | |||||||||||
Treasury Shares | (24) | $ (24) | ||||||||||
Treasury Shares, shares | (7,854) | (7,854,000) | ||||||||||
Net loss | (49,301) | (49,301) | ||||||||||
Ending balances at Dec. 31, 2017 | $ (4,058) | $ 3 | $ 7 | $ (24) | $ 469,877 | $ (473,921) | ||||||
Ending balances, shares at Dec. 31, 2017 | 2,750,000 | 7,007,782 | 7,854,000 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Operating activities | ||
Net loss | $ (49,301) | $ (46,367) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation of property and equipment | 1,852 | 2,041 |
Amortization of financing costs | 20 | 4,402 |
Noncash interest expense | 4,438 | 7,760 |
Share-based compensation expense | 5,583 | 3,792 |
Change in fair value of derivative liabilities | (221) | 549 |
Bad debt expense | 16 | 154 |
Impairment of property and equipment | 3,711 | 28 |
Gain on sale of property and equipment | (175) | (134) |
Changes in: | ||
Accounts receivable | (529) | (474) |
Other receivables | (69) | 320 |
Inventories | 1,279 | 1,400 |
Deferred cost of goods sold | 151 | 173 |
Prepaid expense and other current assets | (65) | 166 |
Other assets | 5 | 126 |
Accounts payable | 1,053 | (2,828) |
Accrued expense | 279 | (424) |
Deferred revenue | 15 | (272) |
Deferred rent liability | (12) | (73) |
Net cash used in operating activities | (31,970) | (29,661) |
Investing activities | ||
Proceeds from sales of property and equipment | 185 | 134 |
Acquisition of property and equipment | (877) | (173) |
Net cash used in investing activities | (692) | (39) |
Financing activities | ||
Repayment of capital lease | (26) | |
Proceeds from issuance of common stock ($40,000 and $20,000 from a related party in 2017 and 2016, respectively), net of issuance costs | 48,792 | 23,964 |
Proceeds from issuance of Series AB ($5,819 received from related party CRG in 2016) | 0 | 5,819 |
Proceeds from exercise of warrants by a related party | 0 | 7,375 |
Costs associated with debt restructuring | (35) | (355) |
Net cash provided by financing activities | 48,757 | 36,777 |
Net increase in cash and cash equivalents | 16,095 | 7,077 |
Cash and cash equivalents—beginning of period | 9,866 | 2,789 |
Cash and cash equivalents—end of period | 25,961 | 9,866 |
Supplemental disclosures of cash flow information | ||
Write off of debt issuance costs | 107 | 0 |
Related party conversion of debt to Series A preferred stock | 27,500 | 0 |
Commitment fee for Purchase Agreement | 411 | 0 |
Treasury shares acquired | 24 | 0 |
Reclassification of derivative liability upon exercise of warrants | 0 | 1,557 |
Cancellation of derivative liability | 0 | 3,036 |
Issuance of derivative liabilities for PPO warrants | 0 | 226 |
Conversion of interest and fees and write off of remaining debt discounts | 0 | 17,934 |
Write off of fully reserved inventory | 0 | 898 |
Issuance of Series AB Preferred Stock warrants | 0 | 4,000 |
Noncash investing and financing transactions | ||
Accrued property and equipment additions | $ 0 | $ 25 |
Consolidated Statements of Cas7
Consolidated Statements of Cash Flows (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Proceeds from issuance of common stock ($40,000 and $20,000 from a related party in 2017 and 2016, respectively), net of issuance costs | $ 48,792 | $ 23,964 |
Proceeds from issuance of Series AB ($5,819 received from related party CRG in 2016) | 0 | 5,819 |
Related party | ||
Proceeds from issuance of common stock ($40,000 and $20,000 from a related party in 2017 and 2016, respectively), net of issuance costs | $ 40,000 | $ 20,000 |
Nature of Operations and Organi
Nature of Operations and Organization | 12 Months Ended |
Dec. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Operations and Organization | NATURE OF OPERATIONS AND ORGANIZATION Organization and Nature of Operations Valeritas Holdings, Inc. (the “Company”) was incorporated in the state of Delaware on May 3, 2016. Prior to its incorporation in Delaware, the Company was incorporated in Florida on May 9, 2014 under the name “Cleaner Yoga Mat, Inc.” Valeritas, Inc., the Company’s wholly-owned subsidiary, was incorporated in the state of Delaware on December 27, 2007, when it was converted into a Delaware corporation from a Delaware limited liability company, which was formed on August 2, 2006 under the name Valeritas LLC. The Company is a commercial-stage medical technology company focused on improving health and simplifying life for people with diabetes by developing and commercializing innovative technologies. The Company’s flagship product, V-Go® Wearable Insulin Delivery device, is a simple, wearable, basal-bolus insulin delivery device for adult patients with type 2 diabetes that enables patients to administer a continuous preset basal rate of insulin over 24 hours. It also provides discreet on-demand bolus dosing at mealtimes. It is the only non-electronic basal-bolus insulin delivery device on the market today specifically designed keeping in mind the needs of adult patients with Type 2 diabetes. V-Go is a small, discreet, easy-to-use wearable and completely disposable insulin delivery device that a patient adheres to his or her skin every 24 hours. V-Go enables patients to closely mimic the body’s normal physiologic pattern of insulin delivery throughout the day and to manage their diabetes with insulin without the need to plan a daily routine around multiple daily injections. As used in these Notes, the terms “Valeritas” and the “private company” refer to the business of Valeritas, Inc. prior to the 2016 Merger (as defined below), and the terms “Valeritas Holdings, Inc.” or the “Company” refers to the combination of Valeritas and Valeritas Holdings, Inc. after giving retrospective effect to the recapitalization under the 2016 Merger. 2016 Reverse Merger and Recapitalization On May 3, 2016 , pursuant to an Agreement and Plan of Merger and Reorganization (the “Merger Agreement”), by and among the Company, Valeritas Acquisition Corp., a Delaware corporation and a direct wholly owned subsidiary of the Company (the “Acquisition Subsidiary”) and Valeritas, Acquisition Subsidiary was merged with and into Valeritas, with Valeritas surviving as a wholly owned subsidiary of the Company. (the “2016 Merger”). Immediately prior to the 2016 Merger, all shares of Valeritas' common stock, Series D Preferred Stock, Series AA Preferred Stock, and shares underlying common stock options and shares underlying the warrants were canceled without consideration. Concurrently with the closing of the 2016 Merger, the shares of Valeritas' Series AB Preferred Stock were canceled and each share was replaced with 0.02982 shares of common stock of the Company. Upon the closing of the 2016 Merger, under the terms of a split-off agreement and a general release agreement, the Company transferred all of its pre-merger operating assets and liabilities to its wholly owned special purpose subsidiary (“Split-Off Subsidiary”), and transferred all of the outstanding shares of capital stock of the Split-Off Subsidiary to the Company's pre-merger majority stockholder (the “Split-Off”) in consideration of and in exchange for (i) the surrender and cancellation of 5,060,750 shares of the Company's common stock held by such stockholder and (ii) certain representations, covenants and indemnities. The 2016 Merger was accounted for as a “reverse merger,” and Valeritas was deemed to be the accounting acquirer in the reverse merger. The historical financial statements prior to the 2016 Merger have been replaced with the historical financial statements of Valeritas. Amounts for Valeritas historical (pre-merger) common stock, preferred stock, warrants, and stock options including share and per share amounts have been retroactively adjusted using their respective exchange ratio in these financial statements, unless otherwise disclosed. Any amounts funded in connection with the original issuance of the common stock, Series D Preferred Stock and Series AA Preferred Stock have been retrospectively adjusted and accounted for as capital contributions as those classes of Valeritas stock did not receive shares of the Company's common stock. in connection with the 2016 Merger. All shares of Valeritas Series AB Preferred Stock have been retrospectively adjusted to shares of the Company's common stock based upon the exchange ratio noted above. |
Liquidity, Uncertainties and Go
Liquidity, Uncertainties and Going Concern | 12 Months Ended |
Dec. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Liquidity, Uncertainties and Going Concern | LIQUIDITY, UNCERTAINTIES AND GOING CONCERN The Company is subject to a number of risks similar to those of early stage companies, including dependence on key individuals and products, the difficulties inherent in the development of a commercial market, the potential need to obtain additional capital necessary to fund the development of its products, competition from larger companies, and other biotechnology companies that develop similar or substitute insulin-delivery products. The Company's sales performance, selling and marketing expenditures to develop sales performance, as well as the status of each of its new product development programs and the resulting operating income (loss), will significantly impact its cash requirements. In accordance with ASC 205-40, Going Concern, the Company has evaluated whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company's ability to continue as a going concern within one year after the date that the consolidated financial statements are issued. The Company has incurred losses each year since inception and has experienced negative cash flows from operations in each year since inception. As of December 31, 2017 and 2016 , the Company had an accumulated deficit of $473.9 million and $424.2 million , respectively. As of December 31, 2017 , the Company had $26.0 million in cash and cash equivalents ( $0.5 million of which is restricted cash) which will not be sufficient to fund the operations of the Company or to maintain its liquidity covenant with the Company's lenders (see Note 7) over the next twelve months from the issuance date of this report. These factors raise substantial doubt regarding the Company’s ability to continue as a going concern. Based on current projections, the Company believes that it has sufficient cash and cash equivalents to finance its current operations into the second half of 2018. The Company is actively pursuing additional sources of financing to fund its operations. The Company can provide no assurances that additional financings will be consummated on acceptable terms, or at all. If the Company is unable to effect a sufficient financing or capital raise, there could be a material adverse effect on the Company. On January 7, 2018, as a component of management's plan to pursue additional financing, the Company entered into a common stock purchase agreement (the "Purchase Agreement") with Aspire Capital Fund, LLC ("Aspire Capital") for the sale of up to $20.0 million of its common stock, as described in further detail in Note 11. Pursuant to the Purchase Agreement, the Company may sell up to an aggregate of 1,375,868 shares of its common stock, (which represents 19.99% of the Company’s outstanding shares of common stock on January 7, 2018), without stockholder approval. The Company may sell additional shares of its common stock above the 19.99% limit provided that (i) it obtains stockholder approval or (ii) shareholder approval has not been obtained and at any time the 1,375,868 share limitation is reached and at all times thereafter the average price paid for all shares issued under the Purchase Agreement, including the 125,000 shares of common stock issued to Aspire Capital in September 2017 as consideration for entering into the Purchase Agreement (the “Commitment Shares”), is equal to or greater than $3.02 (the “Minimum Price”), which was the consolidated closing bid price of the Company’s common stock on January 7, 2018. In addition to these restrictions, the Company is prohibited from selling shares to Aspire under the Purchase Agreement at a price per share less than $1.00 . On January 26, 2018, the Company entered into an At Market Issuance Sales Agreement (the “ATM Agreement”) with B. Riley FBR, Inc. (“FBR”) with respect to an at the market offering program, under which the Company may, from time to time in its sole discretion, issue and sell through FBR, acting as agent, shares of the Company’s common stock (the “Placement Shares”). FBR has the option to decline any sales orders at its discretion. The issuance and sale, if any, of the Placement Shares by the Company under the Agreement will be made pursuant to a prospectus supplement to the Company’s registration statement on Form S-3, originally filed with the Securities and Exchange Commission (the “SEC”) on October 4, 2017, and declared effective by the SEC on December 15, 2017, for the sale of up to $2.8 million of shares of the Company's common stock. There is uncertainty regarding the utilization of financing associated from the January 7, 2018 and the January 26, 2018 agreements, which makes our ability to provide enough cash to fund the operations beyond the second half of 2018 unknown. If the Company was able to fully utilize the $20 million potential funding from the Purchase Agreement, it would have enough cash to support operating requirements into the first quarter of 2019. These consolidated financial statements have been prepared with the assumption that the Company will continue as a going concern and will be able to realize its assets and discharge its liabilities in the normal course of business and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the inability of the Company to continue as a going concern. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Principles of Consolidation The consolidated financial statements reflect the operations of the Company and Valeritas, its wholly-owned subsidiary. All significant intercompany balances and transactions have been eliminated in consolidation. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America ("GAAP") generally requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expense during the period. Actual results could differ from those estimates. Basis of Presentation Reverse Stock Split On March 15, 2017, the Company effected an eight-for-one reverse stock split of its common stock. Adjustments have been made to all periods and amounts presented to reflect the retrospective application of the reverse stock split. Reclassification Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect on the reported results of operations. Change in Accounting Principle On January 1, 2017, the Company adopted Accounting Standards Update ("ASU") ASU 2016-09: Improvements to Employee Share-Based Payment Accounting, to account for forfeitures as they occur. Under ASU 2016-09, all share-based awards will be recognized on a straight-line method, assuming all awards granted will vest. Forfeitures of share-based awards will be recognized in the period in which they occur. Prior to the adoption of ASU 2016-09, share-based compensation cost was measured at grant date, based on the estimated fair value of the award, and was recognized as expense net of expected forfeitures, over the employee’s requisite service period on a straight-line basis. As of January 1, 2017, the cumulative effect adjustment of approximately $0.4 million was recognized to reflect the forfeiture rate that had been applied to unvested option and stock awards prior to January 1, 2017. Segment and Geographic Information Operating segments are defined as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker ("CODM") or decision-making group in making decisions regarding resource allocation and assessing performance. The Company generates its revenue and has employees only in the United States and views its operations as one operating segment as the CODM reviews financial information on a consolidated basis in making decisions regarding resource allocations and assessing performance. The Company owns assets in Asia that are utilized by its contract manufacturer ("CMO") in the manufacture of the Company’s products. Geographic information for property and equipment, net of accumulated depreciation at December 31, 2017 and 2016 is as follows: December 31, (Dollars in thousands) 2017 2016 United States $ 751 $ 920 China 4,718 9,299 Total property and equipment, net $ 5,469 $ 10,219 Cash and cash equivalents The Company considers investments and interest-bearing deposits with original maturities of three months or less to be cash equivalents. At December 31, 2017 and 2016 , there was $25.7 million and $9.6 million , respectively, on deposit at banks in excess of Federal Deposit Insurance Corporation ("FDIC") insured limits. No losses have been experienced on such bank deposits, money market fund or notes. The Company does not believe that it is subject to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships. Restricted Cash The Company held restricted cash of $0.5 million and $0.1 million as at December 31, 2017 and 2016 , respectively as part of its lease agreements. The Company added $0.4 million to restricted cash in 2017 as part of an office equipment lease. The amounts are included within cash and cash equivalents balance. Revenue recognition The Company’s revenue is generated from V-Go sales in the United States to third-party wholesalers and medical supply distributors that, in turn, sell this product to retail pharmacies or directly to patients with diabetes. Revenue is recognized when persuasive evidence of an arrangement exists, delivery has occurred and title passed, the price is fixed or determinable, and collectability is reasonably assured. These criteria are applied as follows: • The evidence of an arrangement generally consists of contractual arrangements with third-party wholesalers and medical supply distributor customers. • Transfer of title and risk and rewards of ownership are passed upon shipment of product to distributors or upon delivery to patients. • The selling prices are fixed and agreed upon based on the contracts with distributors, the customer and contracted insurance payers, if applicable. For sales to customers associated with insurance providers with whom the Company does not have a contract, the Company recognizes revenue upon collection of cash, at which time the price is determinable. Provisions for discounts and rebates to customers are established as a reduction to revenue in the same period the related sales are recorded. • The Company considers the overall creditworthiness and payment history of the distributor, customer and the contracted payer in concluding whether collectability is reasonably assured. Revenue from product sales is recorded net of adjustments for managed care rebates, wholesale distributions fees, cash discounts, prompt pay discounts, and co-pay card redemptions, all of which are established at the time of sale. Accruals for these provisions are presented in the Consolidated Financial Statements as reductions in determining net revenues and as a contra asset in accounts receivable, net (if settled via credit) and other current liabilities (if paid in cash). No significant revisions were made to the methodology used in determining these provisions during the years ended December 31, 2017 and 2016. The following briefly summarizes the nature of our significant provisions: • managed care rebates, which are based on the estimated end user payor mix and related contractual rebates • distribution fees, prompt pay and other discounts, which are recorded based on specified payment terms, and which vary by customer; and • Co-pay card redemption charges which are based on the net transaction costs of prescriptions filled via a Company-subsidized card program The Company believes that their estimates related to managed care rebates, distribution fees, prompt pay and other discounts, and co-pay card redemption costs do not have a high degree of estimation complexity or uncertainty as the related amounts are settled within a relatively short period of time. The Company has entered into agreements with wholesalers, distributors and third-party payors throughout the United States. These agreements may include product discounts or rebates payable by the Company to third-party payors upon dispensing V-Go to patients. Additionally, these agreements customarily provide such wholesalers and medical supply distributors with rights to return purchased products within a specific timeframe, as well as prior to such timeframe if the product is damaged in the normal course of business. The Company's wholesaler and medical supply distributor customers can generally return purchased product during a period that begins six months prior to the purchased V-Go kit expiration date and ends one year after the expiration date. Each V-Go kit expiration date is determined by adding 36 months to the date of manufacture. Returns are no longer honored after delivery to the patient. The Company has historically been unable to reasonably estimate future returns due to lack of sufficient historical return data trends for V-Go. Accordingly, the Company invoices its customers, records deferred revenue equal to the gross invoice sales price less estimated cash discounts and distribution fees, and records a related deferred cost of goods sold. The Company defers recognition of revenue and the related cost of goods sold on shipments of V-Go until a customer's right of return no longer exists, which is once the Company receives evidence that the product has been distributed to patients based on their analysis of third-party information. See "Recently issued accounting policies disclosed below for expected implementation estimates associated with the adoption of ASU 2014-09, Revenue from Contracts with Customers. Major Customers and Concentration of Credit Risk As discussed above, the Company ships product to third-party wholesalers and medical supply distributors that, in turn, sell this product to retail pharmacies or directly to patients with diabetes. Estimated revenue from significant customers as a percentage of the Company’s consolidated gross revenue was as follows: Year Ended December 31, 2017 2016 McKesson Corporation 38.3 % 35.7 % AmerisourceBergen Corporation 28.0 % 31.0 % Cardinal Health 24.6 % 24.3 % The Company’s three largest customers accounted for receivables in excess of ten percent of gross accounts receivable at December 31, 2017 and 2016 : December 31, 2017 2016 Amerisource Bergen Corporation 32.3 % 47.0 % McKesson Corporation 35.4 % 25.4 % Cardinal Health 22.6 % 17.0 % The Company believes that these customers are of high credit quality and that the Company is not subject to unusual risk with respect to such customers, and generally does not require collateral. The Company maintains an allowance for doubtful accounts amounting to a de minimis value as of December 31, 2017 and 2016. Major Vendors The Company maintains a single vendor for production of all finished goods inventory. During the years ended December 31, 2017 and 2016, the Company had aggregate purchases from this vendor of $7.9 million and $6.4 million , respectively. Inventories Inventories consists of raw materials, work in process and finished goods, which are valued at the lower of cost or net realizable value. Cost is determined on a first in, first out ("FIFO"), basis and includes material costs, labor and applicable overhead. The Company reviews its inventory for excess or obsolescence and writes down inventory that has no alternative uses to its net realizable value. Economic conditions, customer demand and changes in purchasing and distribution can affect the carrying value of inventory. As circumstances warrant, the Company records provisions for potentially obsolete or slow moving inventory and lower of cost of market inventory adjustments. In order to determine such adjustments, the Company evaluates the age, inventory turns, future sales forecasts and the estimated fair value of inventory. Property and equipment Property and equipment are carried at cost less accumulated depreciation. Depreciation is recorded on a straight-line basis over the estimated useful lives of the respective assets. Leasehold improvements are depreciated over the shorter of the lease term or the estimated useful life of the asset. Maintenance and repairs are expensed when incurred. Construction-in-Progress Assets under construction at manufacturing facilities are capitalized as construction-in-progress. The cost of construction-in-progress comprises its purchase price and any costs directly attributable to bringing it into working condition for its intended use. Construction-in-progress amounts incurred at manufacturing facilities are presented as a separate asset within property and equipment. Construction-in-progress is not depreciated. Once the asset is complete and available for use, depreciation is commenced. Impairment of Long-Lived Assets Long-lived tangible assets with finite lives are tested for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company’s impairment review process is based upon an estimate of future undiscounted cash flow. Factors they consider that could trigger an impairment review include the following: • significant underperformance relative to expected historical or projected future operating results, • significant changes in the manner of our use of the acquired assets or the strategy for our overall business • significant negative industry or economic trends • significant technological changes, which would render equipment and manufacturing processes obsolete Recoverability of assets that will continue to be used in their operations is measured by comparing the carrying value to the future net undiscounted cash flows expected to be generated by the asset or asset group. Future undiscounted cash flows include estimates of future revenues, driven by market growth rates, and estimated future costs. During the fourth quarter of 2017, the Company performed further analyses of the year-to-date results of operations, compared them with earlier projections and determined that revenues and cash flows from operations were lower than the previously planned amounts. As a result, the Company revised its long term projections of future cash flows, which triggered an impairment review. The impairment review evaluated the estimated future undiscounted cash flows related to specific asset groups and determined that certain long lived assets would require impairment (See Note 5). Warrants The Company accounts for warrant instruments warrants are accounted for as a derivative liability at fair value as the warrant exercise price is subject to adjustment upon additional issuances of equity securities at a price per share lower than the exercise price of the warrants. These warrants are subject to revaluation at each balance sheet date, and any changes in fair value are recorded as a component of other income (expense), until the earlier of their exercise or expiration or the completion of a liquidation event. Income taxes The Company accounts for income taxes using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax reporting purposes and for operating loss and tax credit carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply in the years in which these temporary differences are expected to be recovered or settled. A valuation allowance is established to reduce net deferred tax assets to the amount expected to be realized. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in results of operations in the period that includes the enactment date (see Note 13 for impact of December 22, 2017 enacted "Tax Cuts and Jobs Act"). The Company recognizes the effect of income tax positions only if those positions are more likely than not of being sustained. Recognized income tax positions are measured at the largest amount that is greater than 50% likely of being recognized. Changes in recognition and measurement are reflected in the period in which the change in judgment occurs. Interest and penalties related to unrecognized tax benefits are included in income tax expense. Research and development expenses Research and development expenses are expensed as incurred and are primarily comprised of the following types of costs incurred in performing research and development activities: • contract services; • testing samples and supplies; • salaries and benefits; and • overhead and occupancy costs. Advertising Advertising costs, which include promotional expenses, are included in selling, general and administrative expenses in the consolidated statements of operations and are expensed as incurred. Advertising expenses were $8.5 million and $7.7 million for the years ended December 31, 2017 and 2016, respectively. Share-based compensation The Company measures the cost of awards of equity instruments based on the grant date fair value of the awards. That cost is recognized on a straight-line basis over the period during which the employee is required to provide service in exchange for the award. The fair value of stock options on the date of grant is calculated using the Black Scholes option pricing model, based on key assumptions such as the fair value of common stock, expected volatility and expected term. These estimates require the input of subjective assumptions, including (i) the expected stock price volatility, (ii) the calculation of the expected term of the award, (iii) the risk-free interest rate and (iv) expected dividends. Due to the lack of substantial company-specific historical volatility data of its common stock, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. When selecting these public companies on which it has based its expected stock price volatility, the Company selected companies with comparable characteristics to it, including enterprise value, risk profiles, position within the industry and with historical share price information sufficient to meet the expected term of the stock-based awards. The Company computes historical volatility data using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of the stock-based awards. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. The Company has estimated the expected term of its employee stock options using the “simplified” method, whereby, the expected term equals the arithmetic average of the vesting term and the original contractual term of the option due to its lack of sufficient historical data. The risk-free interest rates for periods within the expected term of the option are based on the U.S. Treasury securities with a maturity date commensurate with the expected term of the associated award. The Company has never paid, and does not expect to pay dividends in the foreseeable future. The Company accounts for forfeitures when they occur. Stock-based compensation expense recognized in the financial statements is reduced by the actual awards forfeited. Compensation cost for restricted stock awards issued to employees is measured using the grant date fair value of the award, and expense is recognized over the service period, adjusted to reflect actual forfeitures. Fair Value Measurements The Company’s financial instruments consist primarily of cash and cash equivalents, accounts receivable, accounts payable and accrued liabilities, debt instruments and derivative liabilities. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value accounting guidance establishes a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value: • Level 1—Quoted prices in active markets for identical assets or liabilities. • Level 2—Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield curves, etc.), and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs). • Level 3—Inputs are unobservable and reflect the Company’s assumptions as to what market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available. It is the Company’s policy to maximize the use of observable inputs and minimize the use of unobservable inputs when developing fair value measurements. When available, the Company uses quoted market prices to measure fair value. If market prices are not available, the fair value measurement is based on models that use primarily market based parameters including interest rate yield curves, option volatilities and currency rates. In certain cases where market rate assumptions are not available, the Company is required to make judgments about assumptions market participants would use to estimate the fair value of a financial instrument. Changes in the underlying assumptions used, including discount rates and estimates of future cash flows could significantly affect the results of current or future values. The results may not be realized in an actual sale or immediate settlement of an asset or liability. Please refer to Note 9 Fair Value Measurements for further discussion of the fair value of financial instruments. Recently Issued Accounting Standards On May 28, 2014 , the Financial Accounting Standards Board ("FASB") issued ASU No. 2014-9, Revenue from Contracts with Customers, which requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. The ASU will replace most existing revenue recognition guidance in U.S. GAAP when it becomes effective. In August 2015, the FASB issued ASU No. 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date, which delayed the effective date of the new standard from January 1, 2017 to January 1, 2018 . The FASB also agreed to allow entities to choose to adopt the standard as of the original effective date. This ASU permits the use of either the retrospective or cumulative effect transition method. The Company has determined that it will use the modified retrospective approach for adoption. The Company had previously deferred recognition of revenue and the related cost of goods sold on shipments of V-Go until a customer's right of return no longer exists, which was once the Company received evidence that the product had been distributed to patients based on analysis of third-party information. Upon adoption, management has determined that the variable consideration associated with rebates, chargebacks and other discounts can continue to be estimated and that there are no return estimate constraints for which it is considered probable that a subsequent change in the estimate would result in a significant revenue reversal under ASU 2014-9. Accordingly, the Company will no longer use the “sell through” approach to recognition and will accelerate the recognition of revenue upon sale to the distributor. The variable consideration associated with sales returns will be estimated based on the probability weighted expected value approach. The Company is substantially complete with its evaluation of the adoption effect on its financial statements. In connection with its adoption of ASC 606, the Company expects to record a cumulative-effect adjustment to reduce retained earnings by $0.5 million upon adoption. This adjustment reflects the acceleration of $1.5 million in revenues, net and $0.5 million in costs of revenue associated with the deferred revenue and related costs at December 31, 2017 as well the reserve for returns approximately $1.5 million . In February 2016, the FASB issued new guidance related to how an entity should recognize lease assets and lease liabilities. The guidance specifies that an entity who is a lessee under lease agreements should recognize lease assets and lease liabilities for those leases classified as operating leases under previous FASB guidance. The guidance is effective for us beginning in the first quarter of 2019. Early adoption is permitted. In transition, lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. The Company is evaluating the impact of adopting this guidance on the Company’s consolidated financial condition, results of operations and cash flows. In August 2016, the FASB issued ASU No. 2016 -15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments that addresses eight specific cash flow presentation and classification issues with the objective of reducing the existing diversity in practice. This amendment is effective for the Company in the fiscal year beginning after December 15, 2017, but early adoption is permissible. The Company does not expect the adoption to have a material impact on the financial statements. In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash (“ASU 2016-18”) that changes the presentation of restricted cash and cash equivalents on the statement of cash flows. Restricted cash and restricted cash equivalents will be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. This amendment is effective for the Company in the fiscal year beginning October 1, 2018 , but early adoption is permissible. The Company has early adopted ASU 2016-18 in this financial statement. In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments-Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities. This ASU addresses certain aspects of recognition, measurement, presentation and disclosure of financial instruments. This ASU is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The Company expects that the adoption will not have a material impact on its financial statements. In July 2017, the FASB issued ASU 2017-11, "Earnings Per Share (Topic 260) Distinguishing Liabilities from Equity (Topic 480) Derivatives and Hedging (Topic 815)," which addresses the complexity of accounting for certain financial instruments with down round features. Down round features are features of certain equity-linked instruments (or embedded features) that result in the strike price being reduced on the basis of the pricing of future equity offerings. Current accounting guidance creates cost and complexity for entities that issue financial instruments (such as warrants and convertible instruments) with down round features that require fair value measurement of the entire instrument or conversion option. The amendments in Part I of this Update are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018 with early adoption permitted. The Company is currently evaluating the impact of adopting this guidance. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2017 | |
Inventory Disclosure [Abstract] | |
Inventory | INVENTORY Inventory, net consists of: December 31, (Dollars in thousands) 2017 2016 Raw materials $ 1,368 $ 1,117 Work in process 1,972 1,434 Finished goods 4,765 6,833 Total $ 8,105 $ 9,384 Cost is determined on a FIFO basis and includes material costs, labor and applicable overhead. The Company reviews its inventory for excess or obsolescence and writes down inventory that has no alternative uses to its net realizable value. The inventory reserves for excess and obsolete inventory at December 31, 2017 and 2016 were $0.3 million and $1.0 million, respectively. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | PROPERTY AND EQUIPMENT Property and equipment consisted of the following: December 31, (Dollars in thousands) Useful lives 2017 2016 Machinery and equipment 5-10 $ 10,552 $ 15,150 Computers and software 3 1,382 1,343 Leasehold improvements 6-10 425 212 Office equipment 5 89 89 Furniture and fixtures 5 187 206 Construction in process 135 114 Total 12,770 17,114 Accumulated depreciation (7,301 ) (6,895 ) Property and equipment, net $ 5,469 $ 10,219 Depreciation and amortization expense for the years ended December 31, 2017 and 2016 was $1.9 million and $2.0 million respectively. For the years ended December 31, 2017 and December 31, 2016 , the Company received proceeds and recognized a gain of $0.2 million and $0.1 million , respectively on the sale of property and equipment, which was previously written off or fully depreciated. The Company evaluated long-lived assets and deemed certain manufacturing lines in China to be impaired. Impairment expense for the years ended December 31, 2017 and December 31, 2016 was $3.7 million and $0.0 million , respectively. |
Accrued Expense and Other Curre
Accrued Expense and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2017 | |
Payables and Accruals [Abstract] | |
Accrued Expense and Other Current Liabilities | ACCRUED EXPENSE AND OTHER CURRENT LIABILITIES The Company’s accrued expenses and other current liabilities consisted of the following: December 31, (Dollars in thousands) 2017 2016 Compensation $ 2,830 $ 2,875 Marketing services 109 949 Distribution agreements and managed care costs 1,330 959 Professional fees 926 291 Franchise taxes 53 52 Travel expenses 157 53 Manufacturing expenses 260 89 Other accruals 133 264 Total $ 5,798 $ 5,532 |
Debt
Debt | 12 Months Ended |
Dec. 31, 2017 | |
Debt Disclosure [Abstract] | |
Debt | DEBT The Company had the following debt outstanding: December 31, (Dollars in thousands) 2017 2016 Senior secured debt $ 25,000 $ 50,000 Payment-in-kind (PIK) interest 7,929 3,852 Issuance costs (125 ) (214 ) Total senior secured debt, net 32,804 53,638 Other note payable 2,500 5,000 Payment-in-kind (PIK) interest 705 340 Total other note payable 3,205 5,340 Total debt $ 36,009 $ 58,978 On May 23, 2013 , the Company entered into the Term Loan of $50.0 million with Capital Royalty Group (“CRG”), structured as a senior secured loan with a six -year term (the “Term Loan” or the “Senior Secured Debt”). In 2015, the Company did not meet the minimum revenue covenant of $50.0 million contained in the Term Loan agreement. Also, the Company did not meet the capital financing targets and was not able to maintain adequate operating cash and working capital, all of which triggered the occurrence of a Material Adverse Change as stipulated within the Term Loan agreement. The Company entered into a series of forbearance agreements, which extended the repayment terms through May 3, 2016 . On January 22, 2016, the Company and CRG amended the forbearance agreement to extend the forbearance period to March 31, 2016. As part of the terms within the forbearance agreement, the Company issued warrants to CRG exercisable into 16.0 million shares of private company Series AB Preferred Stock at $1.25 per share. The warrant had a term of one year . The warrant fair value at the date of issuance was determined to be $4.0 million , using the Black-Scholes option pricing model (see note 8 below). The warrant was accounted for as a debt discount and amortized through to May 3, 2016, when the Term Loan was restructured. Concurrently with the closing of the 2016 Merger on May 3, 2016 , the Company entered into the Second Amended and Restated Term Loan Agreement to restructure its Term Loan and WCAS Note, which extended the payment term of respective principal balances of $50.0 million and $5.0 million to March 31, 2021 and September 8, 2021 , respectively. On February 9, 2017 , the CRG payment terms were further amended to extend the repayments to March 31, 2022 . On February 9, 2017, the Company entered into Amendment No. 1 to the Second Amended and Restated Term Loan Agreement, dated as of May 3, 2016 (the “Loan Agreement”). The Loan Agreement (i) extends the interest only-period of the Loan Agreement by one year to March 31, 2022 from March 31, 2021; (ii) extends the time until the initial required cash interest payments by one year to June 30, 2019 from June 30, 2018; (iii) extends the deadline for full payment under the Loan Agreement to March 31, 2022 from March 31, 2021, and (iv) reduces the Company’s minimum cash and cash equivalent requirements to $2.0 million from the previous requirement of $5.0 million , except that if the Company did not consummate an underwritten public offering with gross proceeds of at least $40.0 million by December 31, 2017, then the minimum cash covenant would have reverted back to $5.0 million . The Company satisfied this requirement with the public offering on March 28, 2017, which raised $48.8 million in net proceeds. On March 28, 2017 , $25.0 million and $2.5 million of the Term Loan and WCAS Note, respectively, were converted to preferred shares upon completion of the public offering at a conversion rate of $10 per share. CRG and WCAS received 2,500,000 and 250,000 preferred shares, respectively. At the time of the debt restructuring, $0.1 million of remaining debt issuance costs were extinguished and recorded against equity as the lender is also a shareholder of the Company. Concurrent with the debt conversion, the Company capitalized a de minimis amount of issuance costs. During the years ended December 31, 2017 and 2016 , the Company incurred non-cash interest expense of $4.4 million and $7.8 million , respectively. Senior Secured Debt The Term Loan is secured by substantially all of the Company’s assets, including its material intellectual property. The Term Loan originally bore interest at 11% per annum and compounds annually. Until the third anniversary of the Term Loan, the Company had the option to pay quarterly interest of 7.5% in cash and 3.5% paid-in-kind, or PIK, interest which is added to the aggregate principal amount of the Term Loan on the last day of each quarter. Thereafter, interest on the Term Loan was payable only in cash. Concurrently with the closing of the 2016 Merger on May 3, 2016 , the Company restructured the Term Loan. CRG converted its outstanding accrued interest and prepayment premium of $16.5 million into 8,609,824 shares of private company Series AB preferred stock and 4,649,859 shares of private company common stock (see WCAS Note Payable for additional conversions during 2016). The private company Series AB shares were then converted into 256,744 of the Company’s common stock upon the 2016 Merger and all private company shares of common stock were canceled upon the 2016 Merger. The principal balance was restated as $50.0 million with interest rate charged at 11% per annum, which is PIK interest through June 30, 2018 and then both PIK and cash interest thereafter. The provisions of the restructured Term Loan require quarterly interest payments during the term of the loan, which were set to commence on June 30, 2018 , but have been adjusted to commence on June 30, 2019 as a result of the February 9, 2017 amendment. The amended repayment of principal on amounts borrowed under the Term Loan was modified to March 31, 2022 . On March 28, 2017 , upon completion of the public offering, CRG converted $25.0 million of the principal balance of the Term Loan into 2,500,000 shares of the Company's newly designated Series A Preferred Stock at a conversion rate of $10 per share. The principal balance of the Term Loan was restated as $25.0 million . The restructured Term Loan agreement contained a financial covenant, which required the Company to maintain a minimum cash balance of $5.0 million . In February 2017, this covenant was amended to require the Company to maintain a minimum cash balance of $2.0 million . As of December 31, 2017 , the Company was in compliance with the financial covenant in the restructured Term Loan agreement, as the Company held cash and cash equivalents of $26.0 million , which includes $0.5 million of restricted cash. Other Note Payable In 2011, the Company issued a $5.0 million senior subordinated note, or the WCAS Note or the Other Note Payable, to WCAS Capital Partners IV, L.P., or WCAS. Amounts due under the WCAS Note originally bore interest at 10% per annum, payable semi-annually. On May 23, 2013 , the WCAS Note was amended such that the note then bore interest at 12% per annum, and all interest accrues as compounded PIK interest and is added to the aggregate principal amount of the loan semi-annually. Upon a change in control, the WCAS note must be prepaid in an amount equal to the outstanding principal balance plus accrued and unpaid interest. The outstanding principal amount of the note, including accrued PIK interest, is due in full in September 2021. The Company may pay off the WCAS Note at any time without penalty. Concurrently with the closing of the 2016 Merger on May 3, 2016 , the Company restructured its WCAS Note. WCAS converted its outstanding accrued interest and fees of $2.1 million to 1,660,530 shares of private company Series AB preferred stock, which were then converted into 49,526 shares of common stock of the Company upon the merger. At the time of the debt restructuring, $0.7 million of remaining debt issuance costs were extinguished and recorded against equity as the lender is also a shareholder of the Company. On March 28, 2017 , $2.5 million of the WCAS Note was converted to preferred shares upon completion of the public offering at a conversion rate of $10 per share. WCAS received 250,000 preferred shares. The remaining principal balance of $2.5 million was amended to decrease the interest rate back to 10% per annum, payable entirely as PIK interest with a debt maturity date of September 21, 2021. No interest payments are required during the term of the loan. |
Derivative Liability
Derivative Liability | 12 Months Ended |
Dec. 31, 2017 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Derivative Liability | DERIVATIVE LIABILITY Private Company Series AB Preferred Stock Warrants On January 29, 2016, Valeritas, Inc. issued CRG warrants to acquire 16,000,000 shares of its Series AB Preferred Stock at an exercise price of $ 1.25 with term of one year from the date of issuance. The warrants were accounted as a derivative liability at fair value because the warrants represented a conditional obligation of the Company to repurchase its shares upon a deemed liquidation event. All shares of Valeritas' Series AB Preferred Stock were cancelled In 2016, CRG exercised warrants to acquire 5,900,000 shares of Valeritas' Series AB Preferred Stock (which represents 175,938 shares of the Company's common stock post-merger) for gross proceeds of $ 7.4 million . The fair value of exercised warrants of $ 1.6 million was reclassified from derivative liability to additional paid in capital. On May 3, 2016, the Company cancelled any outstanding warrants to acquire shares of Valeritas' Series AB Preferred Stock. The remaining derivative liability balance of $ 3.0 million was reclassified from derivative liability to additional paid in capital upon cancellation of the unexercised warrants, and as such, this liability no longer exists. Placement Agent Warrants The Company also issued 10,390 warrants to acquire shares of its common stock to the placement agents in the private placement offering that was conducted as part of the 2016 Merger (the “PPO”). The warrants have a term of five years . The warrants are accounted for as a derivative liability at fair value as the warrant exercise price is subject to adjustment upon additional issuances of equity securities at a price per share lower than the exercise price of the warrants. The fair value of the warrants at the date of issuance was $ 0.3 million . At December 31, 2017 and December 31, 2016 , the fair value of the warrants was estimated to be $ 0.0 million and $0.2 million , respectively, based on the Black Scholes option pricing model. Key assumptions used to apply this model were as follows: May 3, 2016 December 31, 2016 December 31, 2017 Dividend yield — — Expected volatility 80.0 % 67.0 % 69.0 % Risk-free rate of return 1.22 % 1.93 % 2.20 % Expected term (years) 5.0 4.3 3.3 Fair Value per share $ 25.60 $ 21.36 $ 0.09 The activities of the common stock warrants are as follows: Number of shares Weighted average exercise price Weighted average remaining life Outstanding and exercisable—December 31, 2016 10,390 $ 40.00 4.3 years Warrants exercised — — Outstanding and exercisable—December 31, 2017 10,390 $ 16.22 3.3 years On March 28, 2017, the Company sold 5,250,000 shares of its common stock in an underwritten public offering, in which it received net proceeds of approximately $48.8 million . The offering price of $10.00 per share was less than the exercise price of the outstanding warrants. Pursuant to the terms of the warrants issued, the exercise price of those warrants was reduced as a result of the offering. |
Fair Value Measurements and Fai
Fair Value Measurements and Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2017 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements and Fair Value of Financial Instruments | FAIR VALUE MEASUREMENTS AND FAIR VALUE OF FINANCIAL INSTRUMENTS Fair Value Measurements The Company’s financial instruments consist primarily of cash and cash equivalents, accounts receivable, accounts payable and accrued liabilities, debt instruments and derivative liabilities. For accounts receivable, accounts payable and accrued liabilities, the carrying amounts of these financial instruments as of December 31, 2017 and 2016 were considered representative of their fair values due to their short term to maturity. Cash equivalents are carried at cost which approximates their fair value. Debt is carried at its principal balance, plus accrued interest, which approximates its fair value. Debt would be considered a level 2 measurement. The following tables set forth the Company’s financial assets and liabilities that were measured at fair value on a recurring basis as of December 31, 2017 and December 31, 2016 . (Dollars in thousands) As of December 31, 2017 Total Quoted prices in active markets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Derivative liability—warrant $ 1 — — 1 (Dollars in thousands) As of December 31, 2016 Total Quoted prices in active markets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Derivative liability—warrant $ 222 — — 222 The Company’s derivative liabilities are classified within Level 3 because they are valued with an option pricing model, where certain inputs to the model are unobservable and reflect the Company’s assumptions as to what market participants would use. The warrants were valued using the Black Scholes option pricing model (refer to note 8). The life of the warrant is equal to the weighted average remaining contractual life of the warrants. The volatility utilized is based upon the volatilities observed from publicly traded companies that are comparable to the Company. To date, the Company has not declared or paid dividends to any of its shareholders so the assumed dividend rate is zero . The short term risk-free rate utilized is the yield on US Treasury STRIPS corresponding to the life of the warrant. The following table presents the Company’s liabilities measured at fair value using significant unobservable inputs (Level 3), as of December 31, 2017 : (Dollars in Thousands) Balance, December 31, 2015 $ — Issuance of private company Series AB preferred warrant 4,000 Increase for fair value adjustment of warrant liability 662 Decrease for fair value adjustment of exercised warrant (1,557 ) Cancelled warrants (3,036 ) Issuance of common stock warrant in PPO 266 Decrease for fair value adjustment of warrant (113 ) Balance, December 31, 2016 222 Decrease for fair value adjustment of warrant (221 ) Balance, December 31, 2017 $ 1 |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2017 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | RELATED PARTY TRANSACTIONS On September 8, 2011, the Company issued the WCAS Note. Certain affiliates of WCAS are also common stock shareholders as of December 31, 2017 . Concurrently with the closing of the 2016 Merger on May 3, 2016, the Company restructured the WCAS Note. WCAS converted $2.1 million of outstanding interest into 1,660,530 shares of Series AB Preferred Stock, which was converted to 49,526 shares of common stock of the Company. During the year ended December 31, 2016 , CRG participated in additional Series AB financings and exercised its Series AB warrants to acquire additional 10,276,030 shares of Valeritas' Series AB Preferred Stock (which represents 314,761 shares of the Company's common stock after the 2016 Merger) of the Company for gross proceeds of $12.8 million . CRG converted its outstanding accrued interest and prepayment premium of approximately $16.5 million into 8,609,824 shares of Valeritas' Series AB preferred stock and 4,649,859 shares of Valeritas' common stock. The share of Series AB Preferred Stock were then converted into 256,744 shares of the Company’s common stock and all shares of Valeritas' capital stock were canceled upon closing of the 2016 Merger. Upon the closing of the 2016 Merger, the aggregate CRG shares of Series AB Preferred Stock were exchanged for 685,970 shares of common stock in the Company. CRG also took part in the Private Placement (see Note 11), contributing an additional $20.0 million for 500,000 shares of the Company's common stock of Valeritas Holdings. CRG held an aggregate of 5,185,968 and 1,185,970 shares of the Company at December 31, 2017 and 2016, respectively. During the year ended December 31, 2017 , CRG and WCAS converted debt balances of $25.0 million and $2.5 million , respectively, into 2,500,000 and 250,000 shares of the Company's Series A Convertible Preferred Stock, respectively. At the time of the debt restructuring, $0.1 million of remaining debt issuance costs was extinguished and recorded against equity as the lender is also a shareholder of the Company. On March 28, 2017, CRG participated in the Company's initial public offering of common stock, in which it acquired 4,000,000 shares for $40.0 million . |
Stockholders' Deficit
Stockholders' Deficit | 12 Months Ended |
Dec. 31, 2017 | |
Equity [Abstract] | |
Stockholders' Deficit | STOCKHOLDERS’ DEFICIT As a result of the 2016 Merger, the Company's capital structure consisted of 300,000,000 shares of common stock, par value $0.001 per share and 10,000,000 shares of blank check preferred stock. In connection with the Private Placement, the Company issued approximately 0.6 million shares of its common stock at a purchase price of $40.00 per share, for proceeds of approximately $24.0 million , net of financing costs. Existing investors of the Company invested $20.0 million in the Private Placement. On March 8, 2017, the Company’s stockholders approved, and the Company’s board of directors subsequently adopted, an eight-for-one reverse stock split of the Company’s common stock and an increase of the Company's authorized blank check preferred stock from 10,000,000 to 50,000,000 shares. All share and per share numbers in these financial statements have been retrospectively adjusted to reflect the eight-for-one reverse stock split. On March 28, 2017, the Company closed its initial public offering of 5,250,000 shares of common stock at a purchase price of $10.00 per share, for proceeds of approximately $48.8 million , net of financing costs. Existing investors of the Company invested $40.0 million in the public offering. On March 28, 2017, $25.0 million and $2.5 million of the Term Loan and WCAS Note, respectively, were converted to preferred shares. CRG and WCAS received 2,500,000 and 250,000 of the Company's Series A Convertible Preferred Stock, respectively. On September 20, 2017, the Company entered into a common stock purchase agreement with Aspire Capital, which provided that, upon the terms and subject to the conditions and limitations set forth therein, at the Company’s discretion, Aspire Capital would be committed to purchase up to an aggregate of $20.0 million of shares of the Company’s common stock over the 30 -month term of the agreement. As an inducement into entering into the purchase agreement, Aspire Capital was granted the Commitment Shares. The purchase agreement was later terminated. On January 7, 2018, the Company entered into the Purchase Agreement with Aspire Capital, pursuant to which, the Company has the right, in its sole discretion, to present Aspire Capital with a purchase notice, directing Aspire Capital (as principal) to purchase up to 50,000 shares of the Company’s common stock per business day, in an aggregate amount of up to $20.0 million of the Company’s common stock (the "Purchase Shares") over the 30 -month term of the Purchase Agreement at a per share price equal to the lesser of the lowest sale price of the Company’s common stock on the purchase date; or the arithmetic average of the three lowest closing sale prices for the Company’s common stock during the ten consecutive trading days ending on the trading day immediately preceding the purchase date. The Company may sell up to an aggregate of 1,375,868 shares of its common stock (which represents 19.99% of the Company’s outstanding shares of common stock on January 7, 2018) without stockholder approval. The Company may sell additional shares of its common stock above the 19.99% limit provided that (i) it obtains stockholder approval or (ii) shareholder approval has not been obtained at any time the 1,375,868 share limitation is reached and at all times thereafter the average price paid for all shares issued under the Purchase Agreement, including the Commitment Shares, is equal to or greater than the Minimum Price. In addition to these restrictions, the Company is prohibited from selling shares to Aspire under the Purchase Agreement at a price per share less than $1.00 . On February 12, 2018, the Company’s Registration Statement on Form S-1 (File No. 333-222454) for the Purchase Shares and the Commitment Shares became effective. The Company has not issued any shares of its common stock to Aspire Capital under the Purchase Agreement, aside from the Commitment Shares. As of December 31, 2017, the Company has not exercised any purchase rights under the Purchase Agreement. On January 26, 2018, the Company entered into the ATM Agreement FBR with respect to an at the market offering program, under which the Company may, from time to time in its sole discretion, issue and sell through FBR, acting as agent, the Placement Shares. FBR has the option to decline any sales orders at its discretion. The issuance and sale, if any, of the Placement Shares by the Company under the Agreement will be made pursuant to a prospectus supplement to the Company’s registration statement on Form S-3, originally filed with SEC on October 4, 2017, and declared effective by the SEC on December 15, 2017. Preferred Stock Shares of preferred stock may be issued from time to time in one or more series, each of which will have such distinctive designation or title as shall be determined by the Company's Board of Directors prior to the issuance of any shares thereof. The number of authorized shares of preferred stock may be increased or decreased (but not below the number of shares thereof then outstanding) by the affirmative vote of the holders of a majority of the voting power of all the then outstanding shares of the Company's capital stock entitled to vote. On February 14, 2017, the Company entered into an agreement with CRG and WCAS to convert a total of $27.5 million of the outstanding principal amount of the Company's debt, including the Term Loan, into shares of Series A Convertible Preferred Stock at the public offering price. The shares of Series A Preferred Stock are convertible at the option of the holder at any time into shares of the Company's common stock at a conversion rate determined by dividing the Series A Original Issue Price by the Series A Conversion Price (both as defined in the Certificate of Designation) in effect at the time of conversion. This formula initially results in a one -to-one conversion ratio, but may change in the future. The Series A Conversion Price is subject to adjustment for stock splits and the like subsequent to the date of issuance of the Series A Preferred Stock. On or after January 1, 2021, at the Company's option, if the Company has achieved an average market capitalization of at least $300 million for the Company's most recent fiscal quarter, the Company may elect to automatically convert all of the outstanding shares of Series A Preferred Stock into shares of the Company's common stock. The holders of shares of Series A Preferred Stock are entitled to receive cumulative annual dividends at a rate of $8 per every $100 of Series A Preferred Stock, payable either in cash or in shares of the Company's common stock, at each holder’s election; provided, that to the extent any holder elects to receive cash dividends, such dividends shall accrue from day to day and be payable only upon a Deemed Liquidation Event (as defined in the Certificate of Designation). The shares of Series A Preferred Stock will have no voting rights. The Company has the right to redeem all or less than all of the Series A Preferred Stock, at any time, at a price equal to the Series A Conversion Price, as adjusted, plus any accrued but unpaid dividends. In the event of a Deemed Liquidation Event the holders of Series A Preferred Stock are eligible to receive the greater of (i) $27.5 million , plus accrued but unpaid dividends or (ii) what they would have received as a holder of common stock had they converted their shares of Series A Preferred Stock into shares of the Company's common stock immediately prior to the Deemed Liquidation Event. To the extent permitted under Delaware law, the holders of shares of Series A Preferred Stock have the right to prevent the Company from liquidating, dissolving, amending the Company's governing documents in a manner that affects the rights of the Series A Preferred Stock, authorizing shares of capital stock on parity or senior to the Series A Preferred Stock, or issuing any shares of Series A Preferred Stock to any individual, entity or person other than CRG or WCAS. Equity Compensation Plans Total stock-based compensation expense related to stock options and restricted stock was $5.6 million and $3.8 million for the year ended December 31, 2017 and 2016 , respectively, and classified in the consolidated statements of operations as follows: Year Ended December 31, (Dollars in thousands) 2017 2016 Cost of goods sold $ 203 $ 68 Research and development expenses 1,425 526 General and administrative expenses 3,955 3,198 Total share-based compensation $ 5,583 $ 3,792 Employee Stock Purchase Plan Under the Employee Stock Purchase Plan (the “ESPP”), which was established in 2017, the Company is authorized to issue up to 2% of the shares of its capital stock outstanding as of May 3, 2017. The purchase price of the stock will not be less than 85% of the lower of (i) the fair market value per share of the Company's common stock on the start date of the offering period or (ii) the fair market value on the purchase date. The fair market value per share of the Company’s common stock on any particular date under the ESPP will be the closing selling price per share on such date on the national stock exchange serving as the primary market for the Company’s common stock at that time (or if there is no closing price on such date, then the closing selling price per share on the last preceding date for which such quotation exists). Fair value is determined based on two factors: (i) the 15% discount amount on the underlying stock’s market value on the first day of the applicable offering period, and (ii) the fair value of the look-back feature determined by using the Black-Scholes model. The Company recognized $0.1 million of compensation expense for the year ended December 31, 2017. Shares of the Company's common stock will be offered for purchase under the ESPP through a series of successive offering periods. Each offering period will be comprised of one or more successive 6-month purchase intervals, unless determined otherwise by the plan administrator. On the start date of each offering period, each participant will be granted a purchase right to acquire shares of the Company’s common stock on the last day of each purchase interval during that offering period. As of December 31, 2017, no purchase rights have been requested and no shares have been granted under the ESPP. 2008 and 2014 Equity Compensation Plans The final option grant under the 2008 Equity Compensation Plan (the "2008 Plan") was made on May 27, 2014 . No awards were issued in 2017 or 2016 under this plan. The Company recognized share based compensation expense related to awards issued under the 2008 Plan for the year ended December 31, 2017 and 2016 of $0.0 million and $0.2 million respectively. In 2016 the 2008 Plan was terminated. All outstanding options of 20,307,149 units were cancelled. As a result of the cancellation of the plans, the Private Company recognized a one-time expense of $0.9 million during 2016. The Company recognized share based compensation expense related to awards issued under the 2014 Equity Compensation Plan ("2014 Plan") for the years ended December 31, 2017 and 2016 of $0.0 million and $0.7 million , respectively. The 2014 Plan was terminated on May 3, 2016 and all outstanding options then were cancelled. On May 3, 2016 , the 2014 Plan was terminated and all options outstanding thereunder were cancelled. As a result of the cancellation of the plan, the Company recognized a one-time expense of $0.7 million during 2016. 2016 Employee Equity Compensation Plan The Company's 2016 Equity Incentive Compensation plan (the “2016 Plan”) was established concurrently with the 2016 Merger on May 3, 2016. The 2016 Plan permits the Company to grant cash, stock and stock-based awards to its employees, consultants and directors. The 2016 Plan includes (i) the discretionary grant program under which eligible persons may be granted options, including incentive stock options, or ISOs, and nonqualified stock options, or NSOs, or stock appreciation rights, or SARs; (ii) the stock issuance program under which eligible persons may be issued direct stock, restricted stock awards, restricted stock units, performance shares or other stock-based awards; and (iii) the incentive bonus program under which eligible persons may be issued performance unit awards, dividend equivalent rights or cash incentive awards. The Company initially had 2,116,004 shares available for issuance under the 2016 Plan. At December 31, 2017 , an aggregate of 405,620 shares of the Company’s common stock were available for issuance under this plan. The options generally vest over a period of three or four years, and options that lapse or are forfeited are available to be granted again. The contractual life of all options is ten years from the date the option was granted. The restricted stock awards vest on the first, second and third anniversaries of the original grant date. The Company recognizes compensation expense on all of these awards on a straight-line basis over the vesting period. The fair value of the award is determined based on the market value of the underlying stock price at the grant date. Stock Options 2016 Employee Equity Compensation Plan stock option activity for the year ended December 31, 2017 was as follows: Shares Weighted- average exercise price Weighted- average contractual life Aggregate intrinsic value (dollars in thousands) Options outstanding at December 31, 2015 — $ — — — Granted 260,725 40.16 10.00 years 37 Forfeited / Cancelled (7,875 ) 40.00 — — Options outstanding at December 31, 2016 252,850 40.16 9.41 years 37 Granted 1,452,550 7.11 10.0 years $ 91 Forfeited / Cancelled (43,650 ) — — — Options outstanding at December 31, 2017 1,661,750 11.96 9.12 years 75 Options vested and exercisable as of December 31, 2017 493,423 15.64 9.01 years 2 Options vested and expected to vest as of 1,661,750 $ 11.96 9.12 years $ 75 Share based compensation related to options issued under 2016 Plan was $3.9 million and $1.0 million for the years ended December 31, 2017 and 2016, respectively. The weighted average grant date fair value of options granted under the 2016 Plan during the years ended December 31, 2017 and 2016 was $4.39 and $24.56 , respectively. The total grant date fair value of options that vested during both the years ended December 31, 2017 and 2016 was $4.7 million and less than $0.1 million , respectively. There have been no option exercises under the 2016 Plan. As of December 31, 2017 there remained $7.0 million of unrecognized share-based compensation expense related to unvested stock options issued under the 2016 Plan to be recognized as expense over a weighted average period of 2.10 years . The fair value of the options at the date of issuance was estimated based on the Black Scholes option pricing model. Key assumptions used to apply this model upon issuance were as follows: Weighted Average on Grant Date 2017 2016 Dividend yield — — Expected volatility 69.01 % 67.04 % Risk-free rate of return 2.05 % 1.44 % Expected term (years) 5.82 6.12 Fair Value per share $ 4.39 $ 24.56 Restricted Stock During 2017 and 2016, the Company issued restricted stock awards to employees and key consultants. The majority of the grants vest on the first, second and third anniversaries of the original grant date. The Company recognizes compensation expense on all of these awards on a straight-line basis over the vesting period. The fair value of the award is determined based on the market value of the underlying stock price at the grant date. The amount of time-based restricted stock compensation recognized during a period is based on the value of the portion of the awards that are outstanding and ultimately expected to vest. The stock compensation recognized is reduced when forfeitures occur. Ultimately, the actual expense recognized over the vesting period will only be for those awards that vest. Restricted stock award activity for the year ended December 31, 2017 is as follows: Time-Based Restricted Stock Awards Non-vested awards outstanding at December 31, 2015 — Awards granted 56,693 Awards vested and issued (6,093 ) Awards forfeited (1,963 ) Non-vested awards outstanding at December 31, 2016 48,637 Awards granted 30,000 Awards vested and issued (47,658 ) Awards forfeited (979 ) Non-vested awards outstanding at December 31, 2017 30,000 Share based compensation related to restricted stock issued under 2016 Plan was $1.7 million and $0.6 million for the years ended December 31, 2017 and 2016, respectively. The fair value of the restricted stock on the date of issuance granted during 2017 and 2016 was estimated to be $0.1 million and $2.3 million, respectively, and $0.0 million remains in unrecognized compensation related to these awards. The non-vested awards outstanding were not issued under the 2016 Plan. |
Restructuring
Restructuring | 12 Months Ended |
Dec. 31, 2017 | |
Restructuring and Related Activities [Abstract] | |
Restructuring | RESTRUCTURING In February 2016, as part of a restructuring plan, the Company underwent a labor force reduction. The total restructuring costs were $ 2.7 million and consisted of $ 1.2 million severance expense and $ 1.5 million of retention bonuses. The retention bonuses were paid in two installments over the 12 months following the commencement of the restructuring plan. The Company accrued the retention bonus monthly on a straight line basis through the retention period. The second and final installment of the retention bonus was paid in February, 2017. As of December 31, 2016, the severance accrual was $0.3 million . During 2017, $0.3 million in payments were made and there is no balance as of December 31, 2017. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | INCOME TAXES Income tax expense attributable to pretax loss from continuing operations differed from the amounts computed by applying the U.S. federal income tax rate of 34% to pretax loss from continuing operations as a result of the following: Year ended December 31, (Dollars in thousands) 2017 2016 Computed “expected” tax expense $ (16,758 ) $ (15,765 ) Increase (reduction) in income taxes resulting from: Change in the valuation allowance (40,114 ) 9,506 State taxes, net of federal benefit 607 (141 ) Federal research and development credits (236 ) (21 ) Change in Federal Tax Rate 56,105 — Cancellation of Options — 3,451 Nondeductible Interest — 1,976 Stock Compensation — 831 Other, net 396 163 Total income tax expense/(benefit) $ — $ — The tax effects of temporary differences that give rise to significant portions of the deferred tax assets and deferred tax liabilities at December 31, 2017 and 2016 are presented below: December 31, (Dollars in thousands) 2017 2016 Deferred tax assets: Intangible assets $ 6,279 $ 10,062 Net operating loss carryforwards 82,069 117,123 Federal and state credit carryforwards 2,664 2,208 Plant and equipment, due to depreciation and impairment 182 1,100 Inventory reserves 219 589 Other deductible temporary differences 3,178 3,623 Total gross deferred tax assets 94,591 134,705 Less valuation allowance (94,591 ) (134,705 ) Net deferred tax assets $ — $ — At December 31, 2017 , the Company had net operating loss carryforwards for federal income tax purposes of $ 380.3 million which are available to offset future federal taxable income, if any. The federal net operating losses begin to expire in 2028. The Company had net operating loss carryforwards for state income tax purposes of $ 56.2 million which are available to offset future state taxable income, if any. The state net operating losses begin to expire in 2027. Utilization of the net operating loss carryforwards and research and development tax credit carryforwards may be subject to substantial annual limitation under Section 382 of the Internal Revenue Code of 1986, and corresponding provisions of state law, due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income. In general, an ownership change, as define by Section 382, results from transactions increasing the ownership of certain stockholders or public groups in the stock of a corporation by more than 50% over a three-year period. The Company has not conducted a study after December 31, 2014 to determine whether a change of control has occurred or whether there have been multiple changes of control since December 31, 2014 due to the significant complexity and cost associated with such a study. If the Company has experienced a change of control, as defined by Section 382, utilization of the net operating loss carryforwards or research and development tax credit carryforwards would be subject to an annual limitation under Section 382, which is determined by first multiplying the value of the Company’s stock at the time of the ownership change by the applicable long-term tax-exempt rate, and then could be subject to additional adjustments, as required. Any limitation may result in expiration of a portion of the net operating loss carryforwards or research and development tax credit carryforwards before utilization. Further, until a study is completed and any limitation is known, no amounts are being presented as an uncertain tax position. The valuation allowance for deferred tax assets as of December 31, 2017 and 2016 was $ 94.6 million and $ 134.7 million , respectively. The net change in the total valuation allowance was a decrease of $40.0 million in 2017 and an increase of $9.5 million in 2016 . The valuation allowance is primarily related to net operating loss carryforwards that, in the judgment of management, are not more likely than not to be realized. In assessing the realizability of deferred tax assets, management considers whether it is more likely than not that some portion of all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Based upon the level of historical taxable income and projections for future taxable income over the periods in which the deferred tax assets are deductible, management believes that a full valuation allowance is necessary at December 31, 2017 . The Company did not have any unrecognized tax benefits at December 31, 2017 and 2016 . The statute of limitations for assessment by the Internal Revenue Service, or the IRS, and state tax authorities is closed for tax years prior to December 31, 2014 for federal tax purposes and for years prior to December 31, 2014 or 2013 for state tax purposes, although carryforward attributes that were generated in years prior to 2014 may still be adjusted upon examination by the IRS or state tax authorities if they either have been or will be used in a future period. The Company files income tax returns in the U.S. federal and various state jurisdictions. There are currently no federal or state audits in progress. In December 2015, U.S. legislation was enacted to permanently reinstate the Research & Development tax credit (R&D tax credit) which had expired on December 31, 2014. In 2017 and 2016, the Company recorded a benefit of approximately $ 236,000 and $ 21,000 , respectively, for the 2017 R&D Credit. The Tax Cuts and Jobs Act (the Act) was enacted on December 22, 2017. The Act reduces the US federal corporate tax rate from 35% to 21%, requires companies to pay a one-time transition tax on earnings of certain foreign subsidiaries that were previously tax deferred and creates new taxes on certain foreign sourced earnings. As of December 31, 2017 the Company did not have any repatriation of foreign income therefore we recognized a provisional amount of $0 . The Company re-measured certain deferred tax assets and liabilities based on the rates at which they are anticipated to reverse in the future, which is generally 21%. However, the Company is still examining certain aspects of the Act and refining our calculations, which could potentially affect the measurement of these balances or potentially give rise to new deferred tax amounts. The provisional amount recorded related to the re-measurement of our deferred tax balance was a tax expense of $56 million which was fully offset with a valuation allowance against our deferred taxes. |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2017 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plans | EMPLOYEE BENEFIT PLANS The Company sponsors a defined contribution retirement plan for employees pursuant to Section 401(k) of the Internal Revenue Code under which eligible employees can defer a portion of their annual compensation. The Company provides an annual matching contribution based on a percentage of the employee’s contributions. The Company recorded an expense for the matching contributions to the plan for the years ended December 31, 2017 and 2016 of $ 0.2 million and $ 0.2 million , respectively. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2017 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | NET LOSS PER SHARE Basic net loss per share excludes the effect of dilution and is computed by dividing the net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding. Diluted net loss per share is computed by giving effect to all potential shares of common stock, including convertible preferred stock, stock options and warrants to the extent dilutive. Basic net loss per share was the same as diluted net loss per share for the years ended December 31, 2017 and 2016 as the inclusion of all potential common shares outstanding would have an anti-dilutive effect. During the year ended December 31, 2017 , the Company issued shares of its Series A Convertible Preferred Stock. Holders of the Series A Convertible Preferred Stock do not have voting rights and receive cumulative annual dividends of $8 for every $100. Cumulative dividends are presented as a loss attributable to the common shareholders. The following awards outstanding at December 31, 2017 and 2016 were not included in the computation of common shares for the years then ended. Year Ended December 31, Year Ended December 31, 2017 2016 Stock options 1,661,750 252,850 Warrants 10,390 10,390 Restricted stock 30,000 48,637 Preferred stock 2,750,000 — Employee Stock Purchase Program 36,738 — Total 4,488,878 311,877 |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments | COMMITMENTS Operating Leases The Company leases buildings in Shrewsbury, Massachusetts and Bridgewater, New Jersey and equipment under operating lease agreements, expiring in October 2017 and June 2023, respectively. In May 2017, the Company executed a lease agreement for office space in Marlborough, Massachusetts, expiring in 2024, which replaced the Shrewsbury, Massachusetts office space in October 2017. In addition to rental expense, the Company is obligated to pay costs of insurance, taxes, repairs and maintenance pursuant to the terms of the leases. The rental payments include the minimum rentals plus common area maintenance charges. The leases include renewal options. Rental expense under operating leases amounted to $1.9 million and $1.3 million for the years ended December 31, 2017 and 2016 , respectively. At December 31, 2017 , the Company had the following minimum lease commitments: (Dollars in thousands) Year Ended December 31 : 2018 $ 453 2019 523 2020 534 2021 437 2022 436 2023 355 2024 34 Total $ 2,772 Licensing Agreement Pursuant to a formation agreement, dated as of August 22, 2006 (the "Formation Agreement"), BioValve Technologies, Inc. ("BioValve") and BTI Technologies Inc. ("BTI"), a wholly owned subsidiary of BioValve, contributed to Valeritas, Inc. (formerly Valeritas, LLC) all of their right, title and interest in and to all of the assets, properties and rights of BioValve and BTI to the extent related to BioValve’s drug delivery/medical device initiative, consisting of patents and equipment, hereafter referred to as the Device Assets. On August 26, 2008, the Formation Agreement was amended and the Company agreed to pay BioValve an amount equal to 9% of any cash received from upfront license or signing fees and any cash development milestone payments received by the Company in connection with licenses or grants of third party rights to the use in development or commercialization of the Company's Rapid Infuser Technology. In certain circumstances the Company would owe 10% of such payments received. As of December 31, 2017 and 2016 , no amounts were owed under this agreement. Although the Company believes the intellectual property rights around this technology have value, the technology licensed under this agreement is not used in the V-Go or any current products under development. |
Summary of Significant Accoun24
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements reflect the operations of the Company and Valeritas, its wholly-owned subsidiary. All significant intercompany balances and transactions have been eliminated in consolidation. |
Use of estimates | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America ("GAAP") generally requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expense during the period. Actual results could differ from those estimates. |
Segment and Geographic Information | Segment and Geographic Information Operating segments are defined as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker ("CODM") or decision-making group in making decisions regarding resource allocation and assessing performance. The Company generates its revenue and has employees only in the United States and views its operations as one operating segment as the CODM reviews financial information on a consolidated basis in making decisions regarding resource allocations and assessing performance. The Company owns assets in Asia that are utilized by its contract manufacturer ("CMO") in the manufacture of the Company’s products. |
Cash and cash equivalents | Cash and cash equivalents The Company considers investments and interest-bearing deposits with original maturities of three months or less to be cash equivalents. At December 31, 2017 and 2016 , there was $25.7 million and $9.6 million , respectively, on deposit at banks in excess of Federal Deposit Insurance Corporation ("FDIC") insured limits. No losses have been experienced on such bank deposits, money market fund or notes. The Company does not believe that it is subject to any unusual credit risk beyond the normal credit risk associated with commercial banking relationships. Restricted Cash The Company held restricted cash of $0.5 million and $0.1 million as at December 31, 2017 and 2016 , respectively as part of its lease agreements. The Company added $0.4 million to restricted cash in 2017 as part of an office equipment lease. The amounts are included within cash and cash equivalents balance. |
Revenue recognition | Revenue recognition The Company’s revenue is generated from V-Go sales in the United States to third-party wholesalers and medical supply distributors that, in turn, sell this product to retail pharmacies or directly to patients with diabetes. Revenue is recognized when persuasive evidence of an arrangement exists, delivery has occurred and title passed, the price is fixed or determinable, and collectability is reasonably assured. These criteria are applied as follows: • The evidence of an arrangement generally consists of contractual arrangements with third-party wholesalers and medical supply distributor customers. • Transfer of title and risk and rewards of ownership are passed upon shipment of product to distributors or upon delivery to patients. • The selling prices are fixed and agreed upon based on the contracts with distributors, the customer and contracted insurance payers, if applicable. For sales to customers associated with insurance providers with whom the Company does not have a contract, the Company recognizes revenue upon collection of cash, at which time the price is determinable. Provisions for discounts and rebates to customers are established as a reduction to revenue in the same period the related sales are recorded. • The Company considers the overall creditworthiness and payment history of the distributor, customer and the contracted payer in concluding whether collectability is reasonably assured. Revenue from product sales is recorded net of adjustments for managed care rebates, wholesale distributions fees, cash discounts, prompt pay discounts, and co-pay card redemptions, all of which are established at the time of sale. Accruals for these provisions are presented in the Consolidated Financial Statements as reductions in determining net revenues and as a contra asset in accounts receivable, net (if settled via credit) and other current liabilities (if paid in cash). No significant revisions were made to the methodology used in determining these provisions during the years ended December 31, 2017 and 2016. The following briefly summarizes the nature of our significant provisions: • managed care rebates, which are based on the estimated end user payor mix and related contractual rebates • distribution fees, prompt pay and other discounts, which are recorded based on specified payment terms, and which vary by customer; and • Co-pay card redemption charges which are based on the net transaction costs of prescriptions filled via a Company-subsidized card program The Company believes that their estimates related to managed care rebates, distribution fees, prompt pay and other discounts, and co-pay card redemption costs do not have a high degree of estimation complexity or uncertainty as the related amounts are settled within a relatively short period of time. The Company has entered into agreements with wholesalers, distributors and third-party payors throughout the United States. These agreements may include product discounts or rebates payable by the Company to third-party payors upon dispensing V-Go to patients. Additionally, these agreements customarily provide such wholesalers and medical supply distributors with rights to return purchased products within a specific timeframe, as well as prior to such timeframe if the product is damaged in the normal course of business. The Company's wholesaler and medical supply distributor customers can generally return purchased product during a period that begins six months prior to the purchased V-Go kit expiration date and ends one year after the expiration date. Each V-Go kit expiration date is determined by adding 36 months to the date of manufacture. Returns are no longer honored after delivery to the patient. The Company has historically been unable to reasonably estimate future returns due to lack of sufficient historical return data trends for V-Go. Accordingly, the Company invoices its customers, records deferred revenue equal to the gross invoice sales price less estimated cash discounts and distribution fees, and records a related deferred cost of goods sold. The Company defers recognition of revenue and the related cost of goods sold on shipments of V-Go until a customer's right of return no longer exists, which is once the Company receives evidence that the product has been distributed to patients based on their analysis of third-party information. See "Recently issued accounting policies disclosed below for expected implementation estimates associated with the adoption of ASU 2014-09, Revenue from Contracts with Customers. |
Major Customers and Concentration of Credit Risk | Major Customers and Concentration of Credit Risk As discussed above, the Company ships product to third-party wholesalers and medical supply distributors that, in turn, sell this product to retail pharmacies or directly to patients with diabetes. Estimated revenue from significant customers as a percentage of the Company’s consolidated gross revenue was as follows: Year Ended December 31, 2017 2016 McKesson Corporation 38.3 % 35.7 % AmerisourceBergen Corporation 28.0 % 31.0 % Cardinal Health 24.6 % 24.3 % The Company’s three largest customers accounted for receivables in excess of ten percent of gross accounts receivable at December 31, 2017 and 2016 : December 31, 2017 2016 Amerisource Bergen Corporation 32.3 % 47.0 % McKesson Corporation 35.4 % 25.4 % Cardinal Health 22.6 % 17.0 % The Company believes that these customers are of high credit quality and that the Company is not subject to unusual risk with respect to such customers, and generally does not require collateral. |
Inventories | Inventories Inventories consists of raw materials, work in process and finished goods, which are valued at the lower of cost or net realizable value. Cost is determined on a first in, first out ("FIFO"), basis and includes material costs, labor and applicable overhead. The Company reviews its inventory for excess or obsolescence and writes down inventory that has no alternative uses to its net realizable value. Economic conditions, customer demand and changes in purchasing and distribution can affect the carrying value of inventory. |
Property and equipment | Property and equipment Property and equipment are carried at cost less accumulated depreciation. Depreciation is recorded on a straight-line basis over the estimated useful lives of the respective assets. Leasehold improvements are depreciated over the shorter of the lease term or the estimated useful life of the asset. Maintenance and repairs are expensed when incurred. Construction-in-Progress Assets under construction at manufacturing facilities are capitalized as construction-in-progress. The cost of construction-in-progress comprises its purchase price and any costs directly attributable to bringing it into working condition for its intended use. Construction-in-progress amounts incurred at manufacturing facilities are presented as a separate asset within property and equipment. Construction-in-progress is not depreciated. Once the asset is complete and available for use, depreciation is commenced. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Long-lived tangible assets with finite lives are tested for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company’s impairment review process is based upon an estimate of future undiscounted cash flow. Factors they consider that could trigger an impairment review include the following: • significant underperformance relative to expected historical or projected future operating results, • significant changes in the manner of our use of the acquired assets or the strategy for our overall business • significant negative industry or economic trends • significant technological changes, which would render equipment and manufacturing processes obsolete Recoverability of assets that will continue to be used in their operations is measured by comparing the carrying value to the future net undiscounted cash flows expected to be generated by the asset or asset group. Future undiscounted cash flows include estimates of future revenues, driven by market growth rates, and estimated future costs. |
Warrants | Warrants The Company accounts for warrant instruments warrants are accounted for as a derivative liability at fair value as the warrant exercise price is subject to adjustment upon additional issuances of equity securities at a price per share lower than the exercise price of the warrants. These warrants are subject to revaluation at each balance sheet date, and any changes in fair value are recorded as a component of other income (expense), until the earlier of their exercise or expiration or the completion of a liquidation event. |
Income taxes | Income taxes The Company accounts for income taxes using the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax reporting purposes and for operating loss and tax credit carry forwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply in the years in which these temporary differences are expected to be recovered or settled. A valuation allowance is established to reduce net deferred tax assets to the amount expected to be realized. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in results of operations in the period that includes the enactment date (see Note 13 for impact of December 22, 2017 enacted "Tax Cuts and Jobs Act"). The Company recognizes the effect of income tax positions only if those positions are more likely than not of being sustained. Recognized income tax positions are measured at the largest amount that is greater than 50% likely of being recognized. Changes in recognition and measurement are reflected in the period in which the change in judgment occurs. Interest and penalties related to unrecognized tax benefits are included in income tax expense. |
Research and development expenses | Research and development expenses Research and development expenses are expensed as incurred and are primarily comprised of the following types of costs incurred in performing research and development activities: • contract services; • testing samples and supplies; • salaries and benefits; and • overhead and occupancy costs. |
Advertising | Advertising Advertising costs, which include promotional expenses, are included in selling, general and administrative expenses in the consolidated statements of operations and are expensed as incurred. |
Share-based compensation | Share-based compensation The Company measures the cost of awards of equity instruments based on the grant date fair value of the awards. That cost is recognized on a straight-line basis over the period during which the employee is required to provide service in exchange for the award. The fair value of stock options on the date of grant is calculated using the Black Scholes option pricing model, based on key assumptions such as the fair value of common stock, expected volatility and expected term. These estimates require the input of subjective assumptions, including (i) the expected stock price volatility, (ii) the calculation of the expected term of the award, (iii) the risk-free interest rate and (iv) expected dividends. Due to the lack of substantial company-specific historical volatility data of its common stock, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. When selecting these public companies on which it has based its expected stock price volatility, the Company selected companies with comparable characteristics to it, including enterprise value, risk profiles, position within the industry and with historical share price information sufficient to meet the expected term of the stock-based awards. The Company computes historical volatility data using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of the stock-based awards. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. The Company has estimated the expected term of its employee stock options using the “simplified” method, whereby, the expected term equals the arithmetic average of the vesting term and the original contractual term of the option due to its lack of sufficient historical data. The risk-free interest rates for periods within the expected term of the option are based on the U.S. Treasury securities with a maturity date commensurate with the expected term of the associated award. The Company has never paid, and does not expect to pay dividends in the foreseeable future. The Company accounts for forfeitures when they occur. Stock-based compensation expense recognized in the financial statements is reduced by the actual awards forfeited. Compensation cost for restricted stock awards issued to employees is measured using the grant date fair value of the award, and expense is recognized over the service period, adjusted to reflect actual forfeitures. |
Fair Value Measurements | Fair Value Measurements The Company’s financial instruments consist primarily of cash and cash equivalents, accounts receivable, accounts payable and accrued liabilities, debt instruments and derivative liabilities. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. The fair value accounting guidance establishes a fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value: • Level 1—Quoted prices in active markets for identical assets or liabilities. • Level 2—Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs include quoted prices for similar assets and liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, inputs other than quoted prices that are observable for the asset or liability (i.e., interest rates, yield curves, etc.), and inputs that are derived principally from or corroborated by observable market data by correlation or other means (market corroborated inputs). • Level 3—Inputs are unobservable and reflect the Company’s assumptions as to what market participants would use in pricing the asset or liability. The Company develops these inputs based on the best information available. It is the Company’s policy to maximize the use of observable inputs and minimize the use of unobservable inputs when developing fair value measurements. When available, the Company uses quoted market prices to measure fair value. If market prices are not available, the fair value measurement is based on models that use primarily market based parameters including interest rate yield curves, option volatilities and currency rates. In certain cases where market rate assumptions are not available, the Company is required to make judgments about assumptions market participants would use to estimate the fair value of a financial instrument. Changes in the underlying assumptions used, including discount rates and estimates of future cash flows could significantly affect the results of current or future values. The results may not be realized in an actual sale or immediate settlement of an asset or liability. |
Recently Issued Accounting Standards | Recently Issued Accounting Standards On May 28, 2014 , the Financial Accounting Standards Board ("FASB") issued ASU No. 2014-9, Revenue from Contracts with Customers, which requires an entity to recognize the amount of revenue to which it expects to be entitled for the transfer of promised goods or services to customers. The ASU will replace most existing revenue recognition guidance in U.S. GAAP when it becomes effective. In August 2015, the FASB issued ASU No. 2015-14, Revenue from Contracts with Customers (Topic 606): Deferral of the Effective Date, which delayed the effective date of the new standard from January 1, 2017 to January 1, 2018 . The FASB also agreed to allow entities to choose to adopt the standard as of the original effective date. This ASU permits the use of either the retrospective or cumulative effect transition method. The Company has determined that it will use the modified retrospective approach for adoption. The Company had previously deferred recognition of revenue and the related cost of goods sold on shipments of V-Go until a customer's right of return no longer exists, which was once the Company received evidence that the product had been distributed to patients based on analysis of third-party information. Upon adoption, management has determined that the variable consideration associated with rebates, chargebacks and other discounts can continue to be estimated and that there are no return estimate constraints for which it is considered probable that a subsequent change in the estimate would result in a significant revenue reversal under ASU 2014-9. Accordingly, the Company will no longer use the “sell through” approach to recognition and will accelerate the recognition of revenue upon sale to the distributor. The variable consideration associated with sales returns will be estimated based on the probability weighted expected value approach. The Company is substantially complete with its evaluation of the adoption effect on its financial statements. In connection with its adoption of ASC 606, the Company expects to record a cumulative-effect adjustment to reduce retained earnings by $0.5 million upon adoption. This adjustment reflects the acceleration of $1.5 million in revenues, net and $0.5 million in costs of revenue associated with the deferred revenue and related costs at December 31, 2017 as well the reserve for returns approximately $1.5 million . In February 2016, the FASB issued new guidance related to how an entity should recognize lease assets and lease liabilities. The guidance specifies that an entity who is a lessee under lease agreements should recognize lease assets and lease liabilities for those leases classified as operating leases under previous FASB guidance. The guidance is effective for us beginning in the first quarter of 2019. Early adoption is permitted. In transition, lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. The Company is evaluating the impact of adopting this guidance on the Company’s consolidated financial condition, results of operations and cash flows. In August 2016, the FASB issued ASU No. 2016 -15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments that addresses eight specific cash flow presentation and classification issues with the objective of reducing the existing diversity in practice. This amendment is effective for the Company in the fiscal year beginning after December 15, 2017, but early adoption is permissible. The Company does not expect the adoption to have a material impact on the financial statements. In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash (“ASU 2016-18”) that changes the presentation of restricted cash and cash equivalents on the statement of cash flows. Restricted cash and restricted cash equivalents will be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. This amendment is effective for the Company in the fiscal year beginning October 1, 2018 , but early adoption is permissible. The Company has early adopted ASU 2016-18 in this financial statement. In January 2016, the FASB issued ASU No. 2016-01, Financial Instruments-Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities. This ASU addresses certain aspects of recognition, measurement, presentation and disclosure of financial instruments. This ASU is effective for fiscal years beginning after December 15, 2017, including interim periods within those fiscal years. The Company expects that the adoption will not have a material impact on its financial statements. In July 2017, the FASB issued ASU 2017-11, "Earnings Per Share (Topic 260) Distinguishing Liabilities from Equity (Topic 480) Derivatives and Hedging (Topic 815)," which addresses the complexity of accounting for certain financial instruments with down round features. Down round features are features of certain equity-linked instruments (or embedded features) that result in the strike price being reduced on the basis of the pricing of future equity offerings. Current accounting guidance creates cost and complexity for entities that issue financial instruments (such as warrants and convertible instruments) with down round features that require fair value measurement of the entire instrument or conversion option. The amendments in Part I of this Update are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018 with early adoption permitted. The Company is currently evaluating the impact of adopting this guidance. |
Summary of Significant Accoun25
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Geographic Information for Property and Equipment, Net of Accumulated Depreciation | Geographic information for property and equipment, net of accumulated depreciation at December 31, 2017 and 2016 is as follows: December 31, (Dollars in thousands) 2017 2016 United States $ 751 $ 920 China 4,718 9,299 Total property and equipment, net $ 5,469 $ 10,219 |
Major Customers and Concentration of Credit Risk | Estimated revenue from significant customers as a percentage of the Company’s consolidated gross revenue was as follows: Year Ended December 31, 2017 2016 McKesson Corporation 38.3 % 35.7 % AmerisourceBergen Corporation 28.0 % 31.0 % Cardinal Health 24.6 % 24.3 % The Company’s three largest customers accounted for receivables in excess of ten percent of gross accounts receivable at December 31, 2017 and 2016 : December 31, 2017 2016 Amerisource Bergen Corporation 32.3 % 47.0 % McKesson Corporation 35.4 % 25.4 % Cardinal Health 22.6 % 17.0 % |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory | Inventory, net consists of: December 31, (Dollars in thousands) 2017 2016 Raw materials $ 1,368 $ 1,117 Work in process 1,972 1,434 Finished goods 4,765 6,833 Total $ 8,105 $ 9,384 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consisted of the following: December 31, (Dollars in thousands) Useful lives 2017 2016 Machinery and equipment 5-10 $ 10,552 $ 15,150 Computers and software 3 1,382 1,343 Leasehold improvements 6-10 425 212 Office equipment 5 89 89 Furniture and fixtures 5 187 206 Construction in process 135 114 Total 12,770 17,114 Accumulated depreciation (7,301 ) (6,895 ) Property and equipment, net $ 5,469 $ 10,219 |
Accrued Expense and Other Cur28
Accrued Expense and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | The Company’s accrued expenses and other current liabilities consisted of the following: December 31, (Dollars in thousands) 2017 2016 Compensation $ 2,830 $ 2,875 Marketing services 109 949 Distribution agreements and managed care costs 1,330 959 Professional fees 926 291 Franchise taxes 53 52 Travel expenses 157 53 Manufacturing expenses 260 89 Other accruals 133 264 Total $ 5,798 $ 5,532 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Debt Disclosure [Abstract] | |
Debt Outstanding | The Company had the following debt outstanding: December 31, (Dollars in thousands) 2017 2016 Senior secured debt $ 25,000 $ 50,000 Payment-in-kind (PIK) interest 7,929 3,852 Issuance costs (125 ) (214 ) Total senior secured debt, net 32,804 53,638 Other note payable 2,500 5,000 Payment-in-kind (PIK) interest 705 340 Total other note payable 3,205 5,340 Total debt $ 36,009 $ 58,978 |
Derivative Liability (Tables)
Derivative Liability (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Estimated Fair Value of Warrants Assumptions Used for the Black-Scholes Option-pricing Model | Key assumptions used to apply this model were as follows: May 3, 2016 December 31, 2016 December 31, 2017 Dividend yield — — Expected volatility 80.0 % 67.0 % 69.0 % Risk-free rate of return 1.22 % 1.93 % 2.20 % Expected term (years) 5.0 4.3 3.3 Fair Value per share $ 25.60 $ 21.36 $ 0.09 |
Activities of the Common Stock Warrants | The activities of the common stock warrants are as follows: Number of shares Weighted average exercise price Weighted average remaining life Outstanding and exercisable—December 31, 2016 10,390 $ 40.00 4.3 years Warrants exercised — — Outstanding and exercisable—December 31, 2017 10,390 $ 16.22 3.3 years |
Fair Value Measurements and F31
Fair Value Measurements and Fair Value of Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Fair Value Disclosures [Abstract] | |
Summary of Financial Liabilities Measured on Recurring Basis | The following tables set forth the Company’s financial assets and liabilities that were measured at fair value on a recurring basis as of December 31, 2017 and December 31, 2016 . (Dollars in thousands) As of December 31, 2017 Total Quoted prices in active markets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Derivative liability—warrant $ 1 — — 1 (Dollars in thousands) As of December 31, 2016 Total Quoted prices in active markets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Derivative liability—warrant $ 222 — — 222 |
Fair Value, Liabilities Measured on Unobservable Input Reconciliation | The following table presents the Company’s liabilities measured at fair value using significant unobservable inputs (Level 3), as of December 31, 2017 : (Dollars in Thousands) Balance, December 31, 2015 $ — Issuance of private company Series AB preferred warrant 4,000 Increase for fair value adjustment of warrant liability 662 Decrease for fair value adjustment of exercised warrant (1,557 ) Cancelled warrants (3,036 ) Issuance of common stock warrant in PPO 266 Decrease for fair value adjustment of warrant (113 ) Balance, December 31, 2016 222 Decrease for fair value adjustment of warrant (221 ) Balance, December 31, 2017 $ 1 |
Stockholders' Deficit (Tables)
Stockholders' Deficit (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Equity [Abstract] | |
Schedule of Total Stock-Based Compensation Expense Related to Stock Options and Restricted Stock | Total stock-based compensation expense related to stock options and restricted stock was $5.6 million and $3.8 million for the year ended December 31, 2017 and 2016 , respectively, and classified in the consolidated statements of operations as follows: Year Ended December 31, (Dollars in thousands) 2017 2016 Cost of goods sold $ 203 $ 68 Research and development expenses 1,425 526 General and administrative expenses 3,955 3,198 Total share-based compensation $ 5,583 $ 3,792 |
Schedule of Stock Option Activity | 2016 Employee Equity Compensation Plan stock option activity for the year ended December 31, 2017 was as follows: Shares Weighted- average exercise price Weighted- average contractual life Aggregate intrinsic value (dollars in thousands) Options outstanding at December 31, 2015 — $ — — — Granted 260,725 40.16 10.00 years 37 Forfeited / Cancelled (7,875 ) 40.00 — — Options outstanding at December 31, 2016 252,850 40.16 9.41 years 37 Granted 1,452,550 7.11 10.0 years $ 91 Forfeited / Cancelled (43,650 ) — — — Options outstanding at December 31, 2017 1,661,750 11.96 9.12 years 75 Options vested and exercisable as of December 31, 2017 493,423 15.64 9.01 years 2 Options vested and expected to vest as of 1,661,750 $ 11.96 9.12 years $ 75 |
Summary of Key Assumptions to Apply to Model | The fair value of the options at the date of issuance was estimated based on the Black Scholes option pricing model. Key assumptions used to apply this model upon issuance were as follows: Weighted Average on Grant Date 2017 2016 Dividend yield — — Expected volatility 69.01 % 67.04 % Risk-free rate of return 2.05 % 1.44 % Expected term (years) 5.82 6.12 Fair Value per share $ 4.39 $ 24.56 |
Schedule of Time-Based Restricted Stock Awards | Restricted stock award activity for the year ended December 31, 2017 is as follows: Time-Based Restricted Stock Awards Non-vested awards outstanding at December 31, 2015 — Awards granted 56,693 Awards vested and issued (6,093 ) Awards forfeited (1,963 ) Non-vested awards outstanding at December 31, 2016 48,637 Awards granted 30,000 Awards vested and issued (47,658 ) Awards forfeited (979 ) Non-vested awards outstanding at December 31, 2017 30,000 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income Tax Expense | Income tax expense attributable to pretax loss from continuing operations differed from the amounts computed by applying the U.S. federal income tax rate of 34% to pretax loss from continuing operations as a result of the following: Year ended December 31, (Dollars in thousands) 2017 2016 Computed “expected” tax expense $ (16,758 ) $ (15,765 ) Increase (reduction) in income taxes resulting from: Change in the valuation allowance (40,114 ) 9,506 State taxes, net of federal benefit 607 (141 ) Federal research and development credits (236 ) (21 ) Change in Federal Tax Rate 56,105 — Cancellation of Options — 3,451 Nondeductible Interest — 1,976 Stock Compensation — 831 Other, net 396 163 Total income tax expense/(benefit) $ — $ — |
Significant Deferred Tax Assets and Deferred Tax Liabilities | The tax effects of temporary differences that give rise to significant portions of the deferred tax assets and deferred tax liabilities at December 31, 2017 and 2016 are presented below: December 31, (Dollars in thousands) 2017 2016 Deferred tax assets: Intangible assets $ 6,279 $ 10,062 Net operating loss carryforwards 82,069 117,123 Federal and state credit carryforwards 2,664 2,208 Plant and equipment, due to depreciation and impairment 182 1,100 Inventory reserves 219 589 Other deductible temporary differences 3,178 3,623 Total gross deferred tax assets 94,591 134,705 Less valuation allowance (94,591 ) (134,705 ) Net deferred tax assets $ — $ — |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Earnings Per Share [Abstract] | |
Schedule of Antidilutive Options not Included in Computation of Weighted Average Common Shares | The following awards outstanding at December 31, 2017 and 2016 were not included in the computation of common shares for the years then ended. Year Ended December 31, Year Ended December 31, 2017 2016 Stock options 1,661,750 252,850 Warrants 10,390 10,390 Restricted stock 30,000 48,637 Preferred stock 2,750,000 — Employee Stock Purchase Program 36,738 — Total 4,488,878 311,877 |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Summary of Minimum Lease Commitments | At December 31, 2017 , the Company had the following minimum lease commitments: (Dollars in thousands) Year Ended December 31 : 2018 $ 453 2019 523 2020 534 2021 437 2022 436 2023 355 2024 34 Total $ 2,772 |
Nature of Operations and Orga36
Nature of Operations and Organization - Additional Information (Detail) | May 03, 2016shares |
Class of Stock [Line Items] | |
Cancellation of common stock shares held | 5,060,750 |
Series AB Preferred Stock | |
Class of Stock [Line Items] | |
Number of preferred stock converted to common, shares | 0.02982 |
Liquidity, Uncertainties and 37
Liquidity, Uncertainties and Going Concern - Additional Information (Detail) - USD ($) | Jan. 07, 2018 | Jan. 26, 2018 | Dec. 31, 2017 | Sep. 20, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||||
Accumulated deficit | $ 473,921,000 | $ 424,239,000 | ||||
Cash and cash equivalents | 25,961,000 | $ 9,866,000 | $ 2,789,000 | |||
Restricted cash | $ 500,000 | |||||
Minimum | ||||||
Class of Stock [Line Items] | ||||||
Share price (usd per share) | $ 1 | |||||
Aspire Capital | Purchase Agreement | ||||||
Class of Stock [Line Items] | ||||||
Common stock purchase agreement (up to) | $ 20,000,000 | |||||
Aspire Capital | Subsequent Event | ||||||
Class of Stock [Line Items] | ||||||
Shares limited to purchase (shares) | 1,375,868 | |||||
Shares limited to purchase, percent | 19.99% | |||||
Commitment fee for Purchase Agreement, shares | 125,000 | |||||
Aspire Capital | Subsequent Event | Minimum | ||||||
Class of Stock [Line Items] | ||||||
Average price paid (usd per share) | $ 3.02 | |||||
Share price (usd per share) | $ 1 | |||||
Aspire Capital | Subsequent Event | Purchase Agreement | ||||||
Class of Stock [Line Items] | ||||||
Common stock purchase agreement (up to) | $ 20,000,000 | |||||
FBR | Subsequent Event | ATM Agreement | ||||||
Class of Stock [Line Items] | ||||||
Common stock purchase agreement (up to) | $ 2,800,000 |
Summary of Significant Accoun38
Summary of Significant Accounting Policies - Additional Information (Detail) $ in Thousands | Mar. 15, 2017 | Jan. 01, 2017USD ($) |
Accounting Policies [Abstract] | ||
Reverse stock split, shares received for each common share | 0.125 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Cumulative effect of change in accounting principle | $ 0 | |
ASU 2016-09 | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Cumulative effect of change in accounting principle | $ 400 |
Summary of Significant Accoun39
Summary of Significant Accounting Policies - Geographic Information for Property and Equipment, Net of Accumulated Depreciation (Detail) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017USD ($)Segment | Dec. 31, 2016USD ($) | |
Accounting Policies [Abstract] | ||
Number of operating segment | Segment | 1 | |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, net | $ 5,469 | $ 10,219 |
United States | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, net | 751 | 920 |
China | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment, net | $ 4,718 | $ 9,299 |
Summary of Significant Accoun40
Summary of Significant Accounting Policies - Cash and Cash Equivalents (Detail) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Accounting Policies [Abstract] | ||
Deposit at banks in excess of Federal Deposit Insurance Corporation (FDIC) insured limits | $ 25.7 | $ 9.6 |
Restricted cash | 0.5 | $ 0.1 |
Increase in Restricted Cash | $ 0.4 |
Summary of Significant Accoun41
Summary of Significant Accounting Policies - Major Customers and Vendors (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Concentration Risk [Line Items] | ||
Aggregate purchases | $ 12,080 | $ 12,606 |
Customer concentration | Gross Revenue | McKesson Corporation | ||
Concentration Risk [Line Items] | ||
Concentration of credit risk | 38.30% | 35.70% |
Customer concentration | Gross Revenue | AmerisourceBergen Corporation | ||
Concentration Risk [Line Items] | ||
Concentration of credit risk | 28.00% | 31.00% |
Customer concentration | Gross Revenue | Cardinal Health | ||
Concentration Risk [Line Items] | ||
Concentration of credit risk | 24.60% | 24.30% |
Customer concentration | Receivables | McKesson Corporation | ||
Concentration Risk [Line Items] | ||
Concentration of credit risk | 35.40% | 25.40% |
Customer concentration | Receivables | AmerisourceBergen Corporation | ||
Concentration Risk [Line Items] | ||
Concentration of credit risk | 32.30% | 47.00% |
Customer concentration | Receivables | Cardinal Health | ||
Concentration Risk [Line Items] | ||
Concentration of credit risk | 22.60% | 17.00% |
Product [Member] | Vendor | Finished goods inventory | ||
Concentration Risk [Line Items] | ||
Aggregate purchases | $ 7,900 | $ 6,400 |
Summary of Significant Accoun42
Summary of Significant Accounting Policies - Advertising (Detail) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Accounting Policies [Abstract] | ||
Advertising expenses | $ 8.5 | $ 7.7 |
Summary of Significant Accoun43
Summary of Significant Accounting Policies - Recently Issued Accounting Standards (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||
Adjustment to retained earnings | $ 473,921 | $ 424,239 |
Cost of goods sold | 12,080 | $ 12,606 |
Pro forma | Difference between revenue guidance before and after 606 | ASU 2014-09 | ||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||
Adjustment to retained earnings | 500 | |
Acceleration of revenue | 1,500 | |
Cost of goods sold | 500 | |
Reserve for returns | $ 1,500 |
Inventory - Schedule of Invento
Inventory - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 1,368 | $ 1,117 |
Work in process | 1,972 | 1,434 |
Finished goods | 4,765 | 6,833 |
Total | $ 8,105 | $ 9,384 |
Inventory - Additional Informat
Inventory - Additional Information (Detail) - USD ($) $ in Millions | Dec. 31, 2017 | Dec. 31, 2016 |
Inventory Disclosure [Abstract] | ||
Inventory reserves | $ 0.3 | $ 1 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 12,770 | $ 17,114 |
Accumulated depreciation | (7,301) | (6,895) |
Property and equipment, net | 5,469 | 10,219 |
Machinery and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 10,552 | 15,150 |
Machinery and equipment | Minimum | ||
Property, Plant and Equipment [Line Items] | ||
Useful lives | 5 years | |
Machinery and equipment | Maximum | ||
Property, Plant and Equipment [Line Items] | ||
Useful lives | 10 years | |
Computers and software | ||
Property, Plant and Equipment [Line Items] | ||
Useful lives | 3 years | |
Property and equipment, gross | $ 1,382 | 1,343 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 425 | 212 |
Leasehold improvements | Minimum | ||
Property, Plant and Equipment [Line Items] | ||
Useful lives | 6 years | |
Leasehold improvements | Maximum | ||
Property, Plant and Equipment [Line Items] | ||
Useful lives | 10 years | |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Useful lives | 5 years | |
Property and equipment, gross | $ 89 | 89 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Useful lives | 5 years | |
Property and equipment, gross | $ 187 | 206 |
Construction in process | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 135 | $ 114 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation and amortization expense | $ 1,852 | $ 2,041 |
Proceeds from sales of property and equipment | 185 | 134 |
Long-lived asset impairment costs | $ 3,711 | $ 0 |
Accrued Expense and Other Cur48
Accrued Expense and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Payables and Accruals [Abstract] | ||
Compensation | $ 2,830 | $ 2,875 |
Marketing services | 109 | 949 |
Distribution agreements and managed care costs | 1,330 | 959 |
Professional fees | 926 | 291 |
Franchise taxes | 53 | 52 |
Travel expenses | 157 | 53 |
Manufacturing expenses | 260 | 89 |
Other accruals | 133 | 264 |
Total | $ 5,798 | $ 5,532 |
Debt - Debt Outstanding (Detail
Debt - Debt Outstanding (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Debt Instrument [Line Items] | ||
Senior secured debt | $ 32,804 | $ 53,638 |
Issuance costs | (125) | (214) |
Other note payable | 3,205 | 5,340 |
Total debt | 36,009 | 58,978 |
WCAS Capital Partners IV, L.P. | ||
Debt Instrument [Line Items] | ||
Other note payable | 2,500 | 5,000 |
Senior secured debt | ||
Debt Instrument [Line Items] | ||
Senior secured debt | 25,000 | 50,000 |
Payment-in-kind (PIK) interest | ||
Debt Instrument [Line Items] | ||
Senior secured debt | 7,929 | 3,852 |
Other note payable | $ 705 | $ 340 |
Debt - Additional Information (
Debt - Additional Information (Detail) - USD ($) | Mar. 28, 2017 | Feb. 14, 2017 | Feb. 09, 2017 | Feb. 08, 2017 | May 03, 2016 | Jan. 22, 2016 | May 23, 2013 | Dec. 31, 2017 | Dec. 31, 2016 |
Debt Instrument [Line Items] | |||||||||
Senior secured debt, net | $ 32,804,000 | $ 53,638,000 | |||||||
Other note payable | 3,205,000 | 5,340,000 | |||||||
Proceeds from issuance of common stock ($40,000 and $20,000 from a related party in 2017 and 2016, respectively), net of issuance costs | 48,792,000 | 23,964,000 | |||||||
Write off of debt issuance costs | 107,000 | 0 | |||||||
Non-cash interest expense | 4,438,000 | 7,760,000 | |||||||
CRG conversion | Term loan | |||||||||
Debt Instrument [Line Items] | |||||||||
Principal balance converted | $ 25,000,000 | 25,000,000 | |||||||
WCAS conversion | Term loan | |||||||||
Debt Instrument [Line Items] | |||||||||
Principal balance converted | 2,500,000 | ||||||||
Debt conversion CRG and WCAS | |||||||||
Debt Instrument [Line Items] | |||||||||
Write off of debt issuance costs | $ 100,000 | $ 100,000 | |||||||
Debt conversion CRG and WCAS | Term loan | |||||||||
Debt Instrument [Line Items] | |||||||||
Principal balance converted | $ 27,500,000 | ||||||||
Conversion rate (usd per share) | $ 10 | ||||||||
Series AB Preferred Stock | Restructured debt | |||||||||
Debt Instrument [Line Items] | |||||||||
Number of shares issued upon conversion of debt, shares | 1,660,530 | ||||||||
Series A preferred stock | CRG conversion | Preferred Stock | |||||||||
Debt Instrument [Line Items] | |||||||||
Number of shares issued upon conversion of debt, shares | 2,500,000 | 2,500,000 | |||||||
Series A preferred stock | WCAS conversion | Preferred Stock | |||||||||
Debt Instrument [Line Items] | |||||||||
Number of shares issued upon conversion of debt, shares | 250,000 | 250,000 | |||||||
CRG Term Loan | |||||||||
Debt Instrument [Line Items] | |||||||||
Total potential borrowings | $ 50,000,000 | ||||||||
Debt instrument term | 6 years | ||||||||
Minimum revenue covenant | 50,000,000 | ||||||||
Debt Instrument, Extension, Term | 1 year | ||||||||
Cash and cash equivalents covenant held | $ 2,000,000 | $ 5,000,000 | |||||||
Debt Instrument, Covenants, Public Offering Threshold | $ 40,000,000 | ||||||||
Debt Instrument, Covenant, Cash and Cash Equivalents, Public Offing Threshold | $ 5,000,000 | ||||||||
Non-cash interest expense | $ 4,400,000 | $ 7,800,000 | |||||||
CRG Term Loan | Restructured debt | |||||||||
Debt Instrument [Line Items] | |||||||||
Senior secured debt, net | $ 50,000,000 | ||||||||
Other note payable | $ 5,000,000 | ||||||||
CRG Term Loan | Series AB Preferred Stock | |||||||||
Debt Instrument [Line Items] | |||||||||
Number of securities into which the warrants to be converted, shares | 16,000,000 | ||||||||
Warrant exercisable price (usd per share) | $ 1.25 | ||||||||
Term of warrants | 1 year | ||||||||
Fair value of warrant, current | $ 4,000,000 | ||||||||
CRG Term Loan | Series AB Preferred Stock | Restructured debt | Term loan | |||||||||
Debt Instrument [Line Items] | |||||||||
Number of shares issued upon conversion of debt, shares | 8,609,824 | ||||||||
Public Offering | Common Stock | |||||||||
Debt Instrument [Line Items] | |||||||||
Proceeds from issuance of common stock ($40,000 and $20,000 from a related party in 2017 and 2016, respectively), net of issuance costs | $ 48,800,000 |
Debt - Senior Secured Debt (Det
Debt - Senior Secured Debt (Detail) - USD ($) | Mar. 28, 2017 | Feb. 14, 2017 | May 03, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Feb. 28, 2017 | Dec. 31, 2015 | May 23, 2013 |
Debt Instrument [Line Items] | ||||||||
Outstanding accrued interest and prepayment premium conversion, converted amount | $ 0 | $ 17,934,000 | ||||||
Senior secured debt, net | 32,804,000 | 53,638,000 | ||||||
Cash and cash equivalents | 25,961,000 | 9,866,000 | $ 2,789,000 | |||||
Restricted cash | $ 500,000 | |||||||
Series AB Preferred Stock | Restructured debt | ||||||||
Debt Instrument [Line Items] | ||||||||
Outstanding accrued interest and prepayment premium conversion, converted amount | $ 2,100,000 | |||||||
Number of shares issued upon conversion of debt, shares | 1,660,530 | |||||||
Series A preferred stock | Preferred Stock | CRG conversion | ||||||||
Debt Instrument [Line Items] | ||||||||
Number of shares issued upon conversion of debt, shares | 2,500,000 | 2,500,000 | ||||||
CRG Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt interest rate, stated percentage | 11.00% | |||||||
CRG Term Loan | Restructured debt | ||||||||
Debt Instrument [Line Items] | ||||||||
Senior secured debt, net | $ 50,000,000 | |||||||
CRG Term Loan | Restructured debt | Common Stock | ||||||||
Debt Instrument [Line Items] | ||||||||
Number of shares converted | 256,744 | |||||||
Term loan | CRG conversion | ||||||||
Debt Instrument [Line Items] | ||||||||
Principal balance converted | $ 25,000,000 | $ 25,000,000 | ||||||
Term loan | Debt conversion CRG and WCAS | ||||||||
Debt Instrument [Line Items] | ||||||||
Principal balance converted | $ 27,500,000 | |||||||
Conversion rate (usd per share) | $ 10 | |||||||
Term loan | CRG Term Loan | Restructured debt | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt interest rate, stated percentage | 11.00% | |||||||
Minimum cash balance covenant | 5,000,000 | $ 2,000,000 | ||||||
Term loan | CRG Term Loan | Restructured debt | Common Stock | ||||||||
Debt Instrument [Line Items] | ||||||||
Number of shares converted | 4,649,859 | |||||||
Term loan | CRG Term Loan | Series AB Preferred Stock | Restructured debt | ||||||||
Debt Instrument [Line Items] | ||||||||
Outstanding accrued interest and prepayment premium conversion, converted amount | $ 16,500,000 | |||||||
Number of shares issued upon conversion of debt, shares | 8,609,824 | |||||||
Cash interest | CRG Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt interest rate, stated percentage | 7.50% | |||||||
Payment-in-kind (PIK) interest | ||||||||
Debt Instrument [Line Items] | ||||||||
Senior secured debt, net | $ 7,929,000 | $ 3,852,000 | ||||||
Payment-in-kind (PIK) interest | CRG Term Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt interest rate, stated percentage | 3.50% |
Debt - Other Note Payable (Deta
Debt - Other Note Payable (Detail) - USD ($) | Mar. 28, 2017 | Feb. 14, 2017 | May 03, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | May 23, 2013 | Dec. 31, 2011 |
Debt Instrument [Line Items] | |||||||
Outstanding accrued interest and prepayment premium conversion, converted amount | $ 0 | $ 17,934,000 | |||||
Preferred Stock | |||||||
Debt Instrument [Line Items] | |||||||
Issuance of preferred stock upon conversion | 2,750,000 | ||||||
Series A preferred stock | Preferred Stock | WCAS conversion | |||||||
Debt Instrument [Line Items] | |||||||
Number of shares issued upon conversion of debt, shares | 250,000 | 250,000 | |||||
Senior subordinated note | |||||||
Debt Instrument [Line Items] | |||||||
Debt interest rate, stated percentage | 12.00% | ||||||
Term loan | Debt conversion CRG and WCAS | |||||||
Debt Instrument [Line Items] | |||||||
Principal balance converted | $ 27,500,000 | ||||||
Conversion rate (usd per share) | $ 10 | ||||||
Term loan | WCAS conversion | |||||||
Debt Instrument [Line Items] | |||||||
Principal balance converted | $ 2,500,000 | ||||||
Restructured debt | Common Stock | |||||||
Debt Instrument [Line Items] | |||||||
Issuance of preferred stock upon conversion | 49,526 | ||||||
Restructured debt | Series AB Preferred Stock | |||||||
Debt Instrument [Line Items] | |||||||
Outstanding accrued interest and prepayment premium conversion, converted amount | $ 2,100,000 | ||||||
Number of shares issued upon conversion of debt, shares | 1,660,530 | ||||||
Restructured debt | Restructured WCAS Note | WCAS Capital Partners IV, L.P. | |||||||
Debt Instrument [Line Items] | |||||||
Debt, face amount | $ 2,500,000 | $ 5,000,000 | |||||
Debt interest rate, stated percentage | 10.00% | ||||||
Debt extinguished | $ 700,000 | ||||||
Interest payments | $ 0 | ||||||
Restructured debt | Payment-in-kind (PIK) interest | WCAS Capital Partners IV, L.P. | |||||||
Debt Instrument [Line Items] | |||||||
Debt interest rate, stated percentage | 10.00% |
Derivative Liability - Addition
Derivative Liability - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Mar. 28, 2017 | May 03, 2016 | Jan. 29, 2016 | Dec. 31, 2017 | Dec. 31, 2016 |
Derivative Instruments and Hedging Activities Disclosures [Line Items] | |||||
Gross amount | $ 0 | $ 7,375 | |||
Cancellation of derivative liability | 0 | (3,036) | |||
Net proceeds on issuance stock | $ 48,792 | 23,964 | |||
Common Stock | |||||
Derivative Instruments and Hedging Activities Disclosures [Line Items] | |||||
Issuance of common stock, shares | 5,250,000 | ||||
Common Stock | Public Offering | |||||
Derivative Instruments and Hedging Activities Disclosures [Line Items] | |||||
Issuance of common stock, shares | 5,250,000 | ||||
Net proceeds on issuance stock | $ 48,800 | ||||
Share price (usd per share) | $ 10 | ||||
Series AB Preferred Stock Warrant | |||||
Derivative Instruments and Hedging Activities Disclosures [Line Items] | |||||
Number of warrants to acquire shares of common stock, shares | 16,000,000 | ||||
Exercise price (usd per share) | $ 1.25 | ||||
Term of year from the date of issuance | 1 year | ||||
Series AB Preferred Stock Warrant | CRG | |||||
Derivative Instruments and Hedging Activities Disclosures [Line Items] | |||||
Gross amount | 7,400 | ||||
Fair value of exercised warrants | $ 1,600 | ||||
Cancellation of derivative liability | $ 3,000 | ||||
Series AB Preferred Stock Warrant | CRG | Warrants | |||||
Derivative Instruments and Hedging Activities Disclosures [Line Items] | |||||
Issuance of common stock, shares | 5,900,000 | ||||
Series AB Preferred Stock Warrant | CRG | Common Stock | |||||
Derivative Instruments and Hedging Activities Disclosures [Line Items] | |||||
Number of shares issued upon conversion, shares | 175,938 | ||||
Placement Agent Warrants | |||||
Derivative Instruments and Hedging Activities Disclosures [Line Items] | |||||
Warrants issued, shares | 10,390 | ||||
Warrant term | 5 years | ||||
Fair value of the warrant | $ 300 | $ 0 | $ 200 |
Derivative Liability - Schedule
Derivative Liability - Schedule of Fair Value of Equity Classified Warrants (Detail) - $ / shares | May 03, 2016 | Dec. 31, 2017 | Dec. 31, 2016 |
Class of Warrant or Right [Line Items] | |||
Dividend yield | 0.00% | ||
Placement Agent Warrants | |||
Class of Warrant or Right [Line Items] | |||
Dividend yield | 0.00% | 0.00% | |
Expected volatility | 80.00% | 69.00% | 67.00% |
Risk-free rate of return | 1.22% | 2.20% | 1.93% |
Expected term (years) | 5 years | 3 years 3 months 18 days | 4 years 3 months 18 days |
Fair Value per share | $ 25.6 | $ 0.09 | $ 21.36 |
Derivative Liability - Schedu55
Derivative Liability - Schedule of Activities of Warrants (Detail) - Placement Agent Warrants - $ / shares | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Number of shares | ||
Outstanding and exercisable, beginning balance, shares | 10,390 | |
Warrants exercised, shares | 0 | |
Outstanding and exercisable, ending balance, shares | 10,390 | 10,390 |
Weighted average exercise price | ||
Outstanding and exercisable, beginning balance (usd per share) | $ 40 | |
Warrants exercised (usd per share) | 0 | |
Outstanding and exercisable, ending balance (usd per share) | $ 16.22 | $ 40 |
Weighted average remaining life | ||
Outstanding and exercisable | 3 years 3 months 18 days | 4 years 3 months 18 days |
Fair Value Measurements and F56
Fair Value Measurements and Fair Value of Financial Instruments - Summary of Financial Liabilities Measured on Recurring Basis (Detail) - Fair Value, Measurements, Recurring - Warrant liability - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Derivative liability—warrant | $ 1 | $ 222 |
Quoted prices in active markets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Derivative liability—warrant | 0 | 0 |
Significant other observable inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Derivative liability—warrant | 0 | 0 |
Significant unobservable inputs (Level 3) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Derivative liability—warrant | $ 1 | $ 222 |
Fair Value Measurements and F57
Fair Value Measurements and Fair Value of Financial Instruments - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2017 | |
Fair Value Disclosures [Abstract] | |
Assumed dividend rate | 0.00% |
Fair Value Measurements and F58
Fair Value Measurements and Fair Value of Financial Instruments - Liabilities Measured at Fair Value Using Significant Unobservable Inputs (Level 3) (Detail) - Significant unobservable inputs (Level 3) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Beginning balance | $ 222 | $ 0 |
Increase for fair value adjustment of warrant liability | 662 | |
Decrease for fair value adjustment of exercised warrant | (1,557) | |
Cancelled warrants | (3,036) | |
Ending balance | 1 | 222 |
Series AB Preferred Stock | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Issuance of warrant | 4,000 | |
Warranty Liability | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Decrease for fair value adjustment | (113) | |
Common Stock | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Issuance of warrant | $ 266 | |
Decrease for fair value adjustment of exercised warrant | $ (221) |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) $ in Thousands | Mar. 28, 2017 | Feb. 14, 2017 | May 03, 2016 | Dec. 31, 2017 | Dec. 31, 2016 |
Related Party Transaction [Line Items] | |||||
Outstanding accrued interest and prepayment premium conversion, converted amount | $ 0 | $ 17,934 | |||
Gross amount | $ 0 | $ 7,375 | |||
Common stock, shares outstanding | 7,007,782 | 1,590,948 | |||
Write off of debt issuance costs | $ 107 | $ 0 | |||
Issuance of common stock, net of expense | 48,786 | ||||
Private placement offering | |||||
Related Party Transaction [Line Items] | |||||
Issuance of common stock, net of expense | 23,698 | ||||
CRG conversion | Term loan | |||||
Related Party Transaction [Line Items] | |||||
Principal balance converted | $ 25,000 | 25,000 | |||
WCAS conversion | Term loan | |||||
Related Party Transaction [Line Items] | |||||
Principal balance converted | 2,500 | ||||
Debt conversion CRG and WCAS | |||||
Related Party Transaction [Line Items] | |||||
Write off of debt issuance costs | $ 100 | $ 100 | |||
Debt conversion CRG and WCAS | Term loan | |||||
Related Party Transaction [Line Items] | |||||
Principal balance converted | $ 27,500 | ||||
CRG | |||||
Related Party Transaction [Line Items] | |||||
Outstanding accrued interest and prepayment premium conversion, converted amount | 16,500 | ||||
Gross amount | $ 12,800 | ||||
Issuance of common stock, shares | 4,000,000 | ||||
Issuance of common stock, net of expense | $ 40,000 | ||||
Series AB Preferred Stock | CRG | |||||
Related Party Transaction [Line Items] | |||||
Number of shares issued upon conversion of debt, shares | 8,609,824 | ||||
Issuance of common stock as a result of the exercise of warrants by related party, shares | 10,276,030 | ||||
Conversion of Series AB Preferred Stock to Common Stock, shares | 314,761 | ||||
Common Stock | |||||
Related Party Transaction [Line Items] | |||||
Issuance of common stock, shares | 5,250,000 | ||||
Issuance of common stock, net of expense | $ 5 | ||||
Common Stock | Private placement offering | |||||
Related Party Transaction [Line Items] | |||||
Issuance of common stock, shares | 600,000 | 634,858 | |||
Issuance of common stock, net of expense | $ 1 | ||||
Common Stock | CRG | |||||
Related Party Transaction [Line Items] | |||||
Number of shares issued upon conversion of debt, shares | 4,649,859 | ||||
Number of shares issued upon 2016 Merger | 685,970 | ||||
Proceeds from private placement | $ 20,000 | ||||
Common stock, shares outstanding | 1,185,970 | 5,185,968 | |||
Common Stock | CRG | Private placement offering | |||||
Related Party Transaction [Line Items] | |||||
Issuance of common stock, shares | 500,000 | ||||
Common Stock | Series AB Preferred Stock | CRG | |||||
Related Party Transaction [Line Items] | |||||
Issuance of preferred stock upon conversion | 256,744 | ||||
Preferred Stock | |||||
Related Party Transaction [Line Items] | |||||
Issuance of preferred stock upon conversion | 2,750,000 | ||||
Preferred Stock | Series A Convertible Preferred Stock | CRG conversion | |||||
Related Party Transaction [Line Items] | |||||
Number of shares issued upon conversion of debt, shares | 2,500,000 | 2,500,000 | |||
Preferred Stock | Series A Convertible Preferred Stock | WCAS conversion | |||||
Related Party Transaction [Line Items] | |||||
Number of shares issued upon conversion of debt, shares | 250,000 | 250,000 | |||
Restructured debt | Series AB Preferred Stock | |||||
Related Party Transaction [Line Items] | |||||
Outstanding accrued interest and prepayment premium conversion, converted amount | $ 2,100 | ||||
Number of shares issued upon conversion of debt, shares | 1,660,530 | ||||
Restructured debt | Common Stock | |||||
Related Party Transaction [Line Items] | |||||
Issuance of preferred stock upon conversion | 49,526 |
Stockholders' Deficit - Additio
Stockholders' Deficit - Additional Information (Detail) | Jan. 07, 2018USD ($)$ / sharesshares | Sep. 20, 2017USD ($)$ / shares | May 03, 2017 | Mar. 28, 2017USD ($)$ / sharesshares | Mar. 15, 2017 | Feb. 14, 2017USD ($)$ / one_hundred_dollars_of_preferred_stockshares | May 03, 2016USD ($)$ / sharesshares | Dec. 31, 2017USD ($)$ / shares$ / one_hundred_dollars_of_preferred_stockshares | Dec. 31, 2016USD ($)$ / sharesshares | Mar. 08, 2017shares | Mar. 07, 2017shares | Dec. 31, 2011USD ($) |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Common stock, shares authorized | shares | 300,000,000 | 300,000,000 | ||||||||||
Common stock, par value (usd per share) | $ / shares | $ 0.001 | $ 0.001 | ||||||||||
Preferred stock, shares authorized | shares | 10,000,000 | 50,000,000 | 10,000,000 | |||||||||
Reverse stock split, shares received for each common share | 0.125 | |||||||||||
Net proceeds on issuance stock | $ 48,792,000 | $ 23,964,000 | ||||||||||
Average Market capitalization | $ 300,000,000 | |||||||||||
Stock-based compensation expense related to stock options | 5,600,000 | 3,800,000 | ||||||||||
Percent of capital stock authorized issuance for ESPP | 2.00% | |||||||||||
Purchase price of common stock (not less than) (percent) | 85.00% | |||||||||||
Compensation expense | 5,583,000 | 3,792,000 | ||||||||||
Employee Stock Option | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Compensation expense | $ 100,000 | |||||||||||
ESPP shares granted, shares | shares | 0 | |||||||||||
Minimum | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Share price (usd per share) | $ / shares | $ 1 | |||||||||||
2008 Plan | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Stock-based compensation expense related to stock options | 0 | |||||||||||
Compensation expense | $ 0 | $ 200,000 | ||||||||||
Units cancelled, shares | shares | 20,307,149 | |||||||||||
2014 Plan | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Stock-based compensation expense related to stock options | 700,000 | |||||||||||
Compensation expense | $ 0 | $ 700,000 | ||||||||||
2016 Plan | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Initial shares available, shares | shares | 2,116,004 | |||||||||||
Available for issuance, shares | shares | 405,620 | |||||||||||
Contractual life | 10 years | |||||||||||
Share based compensation related to options issued | $ 3,900,000 | $ 1,000,000 | ||||||||||
Weighted average grant date fair value of options granted (usd per share) | $ / shares | $ 4.39 | $ 24.56 | ||||||||||
Options exercised | shares | 0 | |||||||||||
Unrecognized share-based compensation expense related to unvested stock options | $ 7,000,000 | |||||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years 1 month 5 days | |||||||||||
2016 Plan | Time-Based Restricted Stock Awards | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Stock-based compensation expense related to stock options | $ 1,700,000 | $ 600,000 | ||||||||||
Unrecognized share-based compensation expense related to unvested stock options | 0 | |||||||||||
Fair value of restricted stock on date of issuance (usd per share) | $ 100,000 | 2,300,000 | ||||||||||
2016 Plan | Minimum | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Vesting period | 3 years | |||||||||||
2016 Plan | Maximum | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Vesting period | 4 years | |||||||||||
Total grant date fair value of options vested (less than) | $ 4,709,000 | $ 100,000 | ||||||||||
Aspire Capital | Forecast | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Maximum shares available for purchase, shares | shares | 1,375,868 | |||||||||||
Shares limited to purchase, percent | 19.99% | |||||||||||
Aspire Capital | Subsequent Event | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Shares limited to purchase, percent | 19.99% | |||||||||||
Aspire Capital | Subsequent Event | Minimum | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Share price (usd per share) | $ / shares | $ 1 | |||||||||||
Aspire Capital | Purchase Agreement | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Common stock purchase agreement (up to) | $ 20,000,000 | |||||||||||
Term of purchase agreement | 30 months | |||||||||||
Aspire Capital | Purchase Agreement | Subsequent Event | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Common stock purchase agreement (up to) | $ 20,000,000 | |||||||||||
Term of purchase agreement | 30 months | |||||||||||
Commitment to purchase shares, shares | shares | 50,000 | |||||||||||
Series A preferred stock | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Number of preferred stock converted to common, shares | shares | 1 | |||||||||||
Cumulative annual dividends per $100 | $ / one_hundred_dollars_of_preferred_stock | 8 | 8 | ||||||||||
Term loan | CRG conversion | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Principal balance converted | $ 25,000,000 | $ 25,000,000 | ||||||||||
Term loan | WCAS conversion | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Principal balance converted | $ 2,500,000 | |||||||||||
Term loan | Debt conversion CRG and WCAS | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Principal balance converted | $ 27,500,000 | |||||||||||
Restructured debt | Restructured WCAS Note | WCAS Capital Partners IV, L.P. | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Debt, face amount | $ 2,500,000 | $ 5,000,000 | ||||||||||
Common Stock | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Issuance of common stock, shares | shares | 5,250,000 | |||||||||||
Proceeds from private placement, net | $ 24,000,000 | |||||||||||
Common Stock | Existing investor | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Proceeds from private placement | $ 20,000,000 | |||||||||||
Common Stock | Private placement offering | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Issuance of common stock, shares | shares | 600,000 | 634,858 | ||||||||||
Share price (usd per share) | $ / shares | $ 40 | |||||||||||
Common Stock | Public Offering | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Issuance of common stock, shares | shares | 5,250,000 | |||||||||||
Share price (usd per share) | $ / shares | $ 10 | |||||||||||
Net proceeds on issuance stock | $ 48,800,000 | |||||||||||
Common Stock | Public Offering | Existing investor | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Net proceeds on issuance stock | $ 40,000,000 | |||||||||||
Preferred Stock | CRG conversion | Series A preferred stock | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Number of shares issued upon conversion of debt, shares | shares | 2,500,000 | 2,500,000 | ||||||||||
Preferred Stock | WCAS conversion | Series A preferred stock | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Number of shares issued upon conversion of debt, shares | shares | 250,000 | 250,000 |
Stockholders' Deficit - Schedul
Stockholders' Deficit - Schedule of Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation | $ 5,583 | $ 3,792 |
Cost of goods sold | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation | 203 | 68 |
Research and development expenses | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation | 1,425 | 526 |
General and administrative expenses | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total share-based compensation | $ 3,955 | $ 3,198 |
Stockholders' Deficit - Sched62
Stockholders' Deficit - Schedule of Stock Option Activity (Detail) - 2016 Plan - USD ($) $ / shares in Units, $ in Thousands | Dec. 31, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Shares | ||||
Options outstanding beginning balance, shares | 252,850 | 0 | ||
Granted, shares | 1,452,550 | 260,725 | ||
Forfeited / Cancelled, shares | (43,650) | (7,875) | ||
Options outstanding ending balance, shares | 1,661,750 | 1,661,750 | 252,850 | 0 |
Options vested and exercisable, shares | 493,423 | 493,423 | ||
Options vested and expected to vest, shares | 1,661,750 | 1,661,750 | ||
Weighted- average exercise price | ||||
Options outstanding, beginning balance (usd per share) | $ 40.16 | $ 0 | ||
Granted (usd per share) | 7.11 | 40.16 | ||
Forfeited / Cancelled (usd per share) | 0 | 40 | ||
Options outstanding, beginning balance (usd per share) | $ 11.96 | 11.96 | $ 40.16 | $ 0 |
Options vested and exercisable (usd per share) | 15.64 | 15.64 | ||
Options vested and expected to vest (usd per share) | $ 11.96 | $ 11.96 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | ||||
Weighted-average contractual life, Options outstanding | 9 years 1 month 15 days | 9 years 4 months 28 days | 0 years | |
Weighted-average contractual life, Options granted | 10 years | 10 years | ||
Weighted-average contractual life, Options vested and exercisable | 9 years 5 days | |||
Weighted-average contractual life, Options vested and expected to vest | 9 years 1 month 15 days | |||
Aggregate intrinsic value, Options outstanding | $ 37 | $ 0 | ||
Aggregate intrinsic value, Options granted | 91 | 37 | ||
Aggregate intrinsic value, Options outstanding | $ 75 | 75 | $ 37 | $ 0 |
Aggregate intrinsic value, vested and exercisable | 2 | 2 | ||
Aggregate intrinsic value, Vested and expected to vest | $ 75 | $ 75 |
Stockholders' Deficit - Sched63
Stockholders' Deficit - Schedule of Weighted Average Assumptions of Awards Issued (Detail) - 2016 Plan - $ / shares | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Dividend yield | 0.00% | 0.00% |
Expected volatility | 69.01% | 67.04% |
Risk-free rate of return | 2.05% | 1.44% |
Expected term (years) | 5 years 9 months 26 days | 6 years 1 month 13 days |
Fair Value per share | $ 4.39 | $ 24.56 |
Stockholders' Deficit - Sched64
Stockholders' Deficit - Schedule of Time-Based Restricted Stock Awards (Detail) - Time-Based Restricted Stock Awards - shares | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Non-vested awards outstanding, beginning balance, shares | 48,637 | 0 |
Awards granted, shares | 30,000 | 56,693 |
Awards vested and issued, shares | (47,658) | (6,093) |
Awards forfeited, shares | (979) | (1,963) |
Non-vested awards outstanding, ending balance, shares | 30,000 | 48,637 |
Restructuring - Additional Info
Restructuring - Additional Information (Detail) | 1 Months Ended | 12 Months Ended | ||
Feb. 29, 2016USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Jan. 29, 2016Installments | |
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring costs | $ 2,700,000 | |||
Number of installments | Installments | 2 | |||
Severance expense | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring costs | 1,200,000 | |||
Payments | $ 300,000 | |||
Restructuring reserve | $ 0 | $ 300,000 | ||
Retention bonuses | ||||
Restructuring Cost and Reserve [Line Items] | ||||
Restructuring costs | $ 1,500,000 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Income Taxes [Line Items] | ||
Federal income tax rate | 34.00% | |
Valuation allowance | $ 94,591,000 | $ 134,705,000 |
Net change in the total valuation allowance | 40,000,000 | 9,500,000 |
Unrecognized tax benefits | 0 | 0 |
Research and development credits | 236,000 | $ 21,000 |
Recognized provisional tax | 0 | |
Provisional re-measurement of deferred tax balance | 56,000,000 | |
Federal | ||
Income Taxes [Line Items] | ||
Net operating loss carryforwards | 380,300,000 | |
State | ||
Income Taxes [Line Items] | ||
Net operating loss carryforwards | $ 56,200,000 |
Income Taxes - Schedule of Inco
Income Taxes - Schedule of Income Tax Expense (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | ||
Computed “expected” tax expense | $ (16,758) | $ (15,765) |
Increase (reduction) in income taxes resulting from: | ||
Change in the valuation allowance | (40,114) | 9,506 |
State taxes, net of federal benefit | 607 | (141) |
Federal research and development credits | (236) | (21) |
Change in Federal Tax Rate | 56,105 | 0 |
Cancellation of Options | 0 | 3,451 |
Nondeductible Interest | 0 | 1,976 |
Stock Compensation | 0 | 831 |
Other, net | 396 | 163 |
Total income tax expense/(benefit) | $ 0 | $ 0 |
Income Taxes - Significant Defe
Income Taxes - Significant Deferred Tax Assets and Deferred Tax Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Deferred tax assets: | ||
Intangible assets | $ 6,279 | $ 10,062 |
Net operating loss carryforwards | 82,069 | 117,123 |
Federal and state credit carryforwards | 2,664 | 2,208 |
Plant and equipment, due to depreciation and impairment | 182 | 1,100 |
Inventory reserves | 219 | 589 |
Other deductible temporary differences | 3,178 | 3,623 |
Total gross deferred tax assets | 94,591 | 134,705 |
Less valuation allowance | (94,591) | (134,705) |
Net deferred tax assets | $ 0 | $ 0 |
Employee Benefit Plans - Additi
Employee Benefit Plans - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Retirement Benefits [Abstract] | ||
Defined contribution plan employers matching contribution | $ 0.2 | $ 0.2 |
Net Loss per Share - Additional
Net Loss per Share - Additional Information (Detail) - $ / one_hundred_dollars_of_preferred_stock | Feb. 14, 2017 | Dec. 31, 2017 |
Series A preferred stock | ||
Earnings Per Share [Line Items] | ||
Cumulative annual dividends per $100 | 8 | 8 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Antidilutive Options not Included in Computation of Weighted Average Common Shares (Detail) - shares | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securities excluded from computation of weighted average common shares | 4,488,878 | 311,877 |
Stock options | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securities excluded from computation of weighted average common shares | 1,661,750 | 252,850 |
Warrants | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securities excluded from computation of weighted average common shares | 10,390 | 10,390 |
Restricted stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securities excluded from computation of weighted average common shares | 30,000 | 48,637 |
Preferred Stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securities excluded from computation of weighted average common shares | 2,750,000 | 0 |
Employee Stock Purchase Program | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Securities excluded from computation of weighted average common shares | 36,738 | 0 |
Commitments - Additional Inform
Commitments - Additional Information (Detail) - USD ($) | Aug. 22, 2008 | Dec. 31, 2017 | Dec. 31, 2016 |
Commitments and Contingencies Disclosure [Abstract] | |||
Rent expense | $ 1,900,000 | $ 1,300,000 | |
BioValve | |||
Commitments And Contingencies [Line Items] | |||
Licensing payment | 9.00% | ||
Licensing payment | 10.00% | ||
Amounts owed | $ 0 | $ 0 |
Commitments - Summary of Minimu
Commitments - Summary of Minimum Lease Commitments (Detail) $ in Thousands | Dec. 31, 2017USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2,018 | $ 453 |
2,019 | 523 |
2,020 | 534 |
2,021 | 437 |
2,022 | 436 |
2,023 | 355 |
2,024 | 34 |
Total | $ 2,772 |
Uncategorized Items - vlrx-2017
Label | Element | Value |
Additional Paid-in Capital [Member] | ||
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | $ 381,000 |
Retained Earnings [Member] | ||
Cumulative Effect of New Accounting Principle in Period of Adoption | us-gaap_CumulativeEffectOfNewAccountingPrincipleInPeriodOfAdoption | $ (381,000) |