Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Mar. 01, 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 | ATRS | ||
Entity Registrant Name | ANTARES PHARMA, INC. | ||
Entity Central Index Key | 1,016,169 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Common Stock, Shares Outstanding | 156,788,986 | ||
Entity Public Float | $ 459,300,000 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Current Assets: | ||
Cash and cash equivalents | $ 26,562,000 | $ 27,715,000 |
Short-term investments | 4,993,000 | 0 |
Accounts receivable | 11,878,000 | 9,073,000 |
Inventories | 9,275,000 | 5,327,000 |
Deferred costs | 505,000 | 1,773,000 |
Prepaid expenses and other current assets | 2,323,000 | 1,376,000 |
Total current assets | 55,536,000 | 45,264,000 |
Equipment, molds, furniture and fixtures, net | 16,158,000 | 17,867,000 |
Patent rights, net | 1,401,000 | 2,045,000 |
Goodwill | 1,095,000 | 1,095,000 |
Other assets | 148,000 | 54,000 |
Total Assets | 74,338,000 | 66,325,000 |
Current Liabilities: | ||
Accounts payable | 5,957,000 | 7,885,000 |
Accrued expenses and other liabilities | 6,982,000 | 5,873,000 |
Deferred revenue | 2,794,000 | 6,149,000 |
Total current liabilities | 15,733,000 | 19,907,000 |
Long-term debt | 24,858,000 | |
Deferred revenue – long term | 200,000 | 1,200,000 |
Total liabilities | 40,791,000 | 21,107,000 |
Stockholders’ Equity: | ||
Preferred Stock: $0.01 par, authorized 3,000,000 shares, none outstanding | ||
Common Stock: $0.01 par; authorized 300,000,000 shares; 156,674,504 and 155,167,677 issued and outstanding at December 31, 2017 and 2016, respectively | 1,567,000 | 1,552,000 |
Additional paid-in capital | 302,965,000 | 297,826,000 |
Accumulated deficit | (270,285,000) | (253,445,000) |
Accumulated other comprehensive loss | (700,000) | (715,000) |
Total Stockholders' Equity | 33,547,000 | 45,218,000 |
Total Liabilities and Stockholders’ Equity | $ 74,338,000 | $ 66,325,000 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2017 | Dec. 31, 2016 |
Statement Of Financial Position [Abstract] | ||
Preferred Stock, par value | $ 0.01 | $ 0.01 |
Preferred Stock, shares authorized | 3,000,000 | 3,000,000 |
Preferred Stock, shares outstanding | 0 | 0 |
Common Stock, par value | $ 0.01 | $ 0.01 |
Common Stock, shares authorized | 300,000,000 | 300,000,000 |
Common Stock, shares issued | 156,674,504 | 155,167,677 |
Common Stock, shares outstanding | 156,674,504 | 155,167,677 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Revenue: | |||
Product sales | $ 41,695 | $ 40,318 | $ 27,533 |
Development revenue | 10,095 | 10,235 | 8,892 |
Licensing revenue | 1,076 | 166 | 7,242 |
Royalties | 1,649 | 1,503 | 1,991 |
Total revenue | 54,515 | 52,222 | 45,658 |
Cost of revenue: | |||
Cost of product sales | 22,317 | 23,909 | 12,925 |
Cost of development revenue | 5,149 | 4,908 | 6,533 |
Total cost of revenue | 27,466 | 28,817 | 19,458 |
Gross profit | 27,049 | 23,405 | 26,200 |
Operating expenses: | |||
Research and development | 13,147 | 21,127 | 19,731 |
Selling, general and administrative | 30,353 | 26,395 | 26,931 |
Total operating expenses | 43,500 | 47,522 | 46,662 |
Operating loss | (16,451) | (24,117) | (20,462) |
Other income (expense): | |||
Gain on sale of assets | 860 | ||
Interest expense | (1,423) | ||
Other, net | 271 | (122) | (22) |
Total other expense | (292) | (122) | (22) |
Net loss before income taxes | (16,743) | (24,239) | (20,484) |
Income tax provision | 100 | 175 | |
Net loss | $ (16,743) | $ (24,339) | $ (20,659) |
Basic and diluted net loss per common share | $ (0.11) | $ (0.16) | $ (0.14) |
Basic and diluted weighted average common shares outstanding | 156,054,094 | 154,992,124 | 146,594,079 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Statement Of Income And Comprehensive Income [Abstract] | |||
Net loss | $ (16,743) | $ (24,339) | $ (20,659) |
Foreign currency translation adjustment | 15 | (23) | 14 |
Comprehensive loss | $ (16,728) | $ (24,362) | $ (20,645) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive Loss [Member] |
Balance at Dec. 31, 2014 | $ 41,196 | $ 1,317 | $ 249,032 | $ (208,447) | $ (706) |
Balance, shares at Dec. 31, 2014 | 131,743,365 | ||||
Issuance of common stock | 42,850 | $ 230 | 42,620 | ||
Issuance of common stock, shares | 23,000,000 | ||||
Common stock issued under equity compensation plan, net of shares withheld for taxes | (49) | $ 1 | (50) | ||
Common stock issued under equity compensation plan, net of shares withheld for taxes, shares | 85,147 | ||||
Exercise of warrants and options | 31 | 31 | |||
Exercise of warrants and options, shares | 20,000 | ||||
Share-based compensation | 3,659 | 3,659 | |||
Net loss | (20,659) | (20,659) | |||
Other comprehensive income (loss) | 14 | 14 | |||
Balance at Dec. 31, 2015 | 67,042 | $ 1,548 | 295,292 | (229,106) | (692) |
Balance, shares at Dec. 31, 2015 | 154,848,512 | ||||
Common stock issued under equity compensation plan, net of shares withheld for taxes | (84) | $ 2 | (86) | ||
Common stock issued under equity compensation plan, net of shares withheld for taxes, shares | 216,389 | ||||
Exercise of options | 101 | $ 1 | 100 | ||
Exercise of options, shares | 102,776 | ||||
Share-based compensation | 2,520 | 2,520 | |||
Net loss | (24,339) | (24,339) | |||
Other comprehensive income (loss) | (23) | (23) | |||
Balance at Dec. 31, 2016 | 45,218 | $ 1,552 | 297,826 | (253,445) | (715) |
Balance, shares at Dec. 31, 2016 | 155,167,677 | ||||
Common stock issued under equity compensation plan, net of shares withheld for taxes | (249) | $ 2 | (251) | ||
Common stock issued under equity compensation plan, net of shares withheld for taxes, shares | 195,534 | ||||
Exercise of options | 1,816 | $ 13 | 1,803 | ||
Exercise of options, shares | 1,311,293 | ||||
Share-based compensation | 3,490 | 3,490 | |||
Net loss | (16,743) | (16,743) | |||
Cumulative effect of change in accounting principle | 97 | (97) | |||
Other comprehensive income (loss) | 15 | 15 | |||
Balance at Dec. 31, 2017 | $ 33,547 | $ 1,567 | $ 302,965 | $ (270,285) | $ (700) |
Balance, shares at Dec. 31, 2017 | 156,674,504 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Cash flows from operating activities: | |||
Net loss | $ (16,743,000) | $ (24,339,000) | $ (20,659,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Share-based compensation expense | 3,490,000 | 2,520,000 | 3,659,000 |
Depreciation and amortization | 2,104,000 | 1,861,000 | 1,570,000 |
Gain on sale of assets | (860,000) | ||
Loss on disposal of equipment | 22,000 | 262,000 | 167,000 |
Write-off of capitalized patent costs | 46,000 | 0 | 31,000 |
Increase in inventory reserve | 356,000 | 748,000 | 700,000 |
Accretion of interest expense | 119,000 | ||
Amortization of debt issuance costs | 33,000 | ||
Amortization of premiums and discounts on investment securities | (33,000) | 12,000 | 10,000 |
Changes in operating assets and liabilities: | |||
Accounts receivable | (2,798,000) | (1,138,000) | (4,423,000) |
Inventories | (4,304,000) | (351,000) | (564,000) |
Prepaid expenses and other current assets | (942,000) | 1,922,000 | (934,000) |
Deferred costs | 1,268,000 | (574,000) | 715,000 |
Other assets | (94,000) | 100,000 | 148,000 |
Accounts payable | (1,522,000) | 2,859,000 | (3,495,000) |
Accrued expenses and other liabilities | 1,122,000 | (582,000) | 906,000 |
Deferred revenue | (4,358,000) | 1,505,000 | (6,030,000) |
Net cash used in operating activities | (23,094,000) | (15,195,000) | (28,199,000) |
Cash flows from investing activities: | |||
Purchases of equipment, molds, furniture and fixtures | (1,167,000) | (4,880,000) | (5,643,000) |
Additions to patent rights | (101,000) | (127,000) | (1,043,000) |
Proceeds from sale of assets, net of transaction costs | 1,901,000 | ||
Proceeds from maturities of investment securities | 5,000,000 | 15,000,000 | 6,000,000 |
Purchases of investment securities | (9,964,000) | (15,038,000) | |
Net cash provided by (used in) investing activities | (4,331,000) | 9,993,000 | (15,724,000) |
Cash flows from financing activities: | |||
Proceeds from issuance of long-term debt | 25,000,000 | ||
Payment of debt issuance costs | (294,000) | ||
Proceeds from issuance of common stock, net | 42,851,000 | ||
Proceeds from exercise of stock options | 1,816,000 | 101,000 | 31,000 |
Taxes paid related to net share settlement of equity awards | (249,000) | (84,000) | (88,000) |
Net cash provided by financing activities | 26,273,000 | 17,000 | 42,794,000 |
Effect of exchange rate changes on cash | (1,000) | 1,000 | (1,000) |
Net decrease in cash and cash equivalents | (1,153,000) | (5,184,000) | (1,130,000) |
Cash and cash equivalents: | |||
Beginning of year | 27,715,000 | 32,899,000 | 34,029,000 |
End of year | 26,562,000 | 27,715,000 | 32,899,000 |
Supplemental disclosure of non-cash investing activities: | |||
Purchases of equipment, molds, furniture and fixtures recorded in accounts payable and accrued expenses | 40,000 | 424,000 | 641,000 |
Additions to patent rights recorded in accounts payable and accrued expenses | $ 10,000 | $ 45,000 | $ 21,000 |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2017 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Description of Business | 1. Description of Business Antares Pharma, Inc. (“Antares” or the “Company”) is a specialty pharmaceutical company focused on the development and commercialization of self-administered parenteral pharmaceutical products and technologies. The Company develops and manufactures, for itself or with partners, novel therapeutic products using its advanced drug delivery technology to enhance the existing drug compounds and delivery methods. The subcutaneous injection technology platforms include the VIBEX ® ® ® The Company markets and sells its proprietary product OTREXUP ® ® ® Through its commercialization partner Teva, the Company sells Sumatriptan Injection USP, indicated in the U.S. for the acute treatment of migraine and cluster headache in adults. In December 2015, the Company received FDA approval for an Abbreviated New Drug Application (“ANDA”) for 4 mg/0.5 mL and 6 mg/0.5 mL single-dose prefilled syringe auto-injectors, a generic equivalent to Imitrex ® ® ® In collaboration with AMAG, the Company developed a subcutaneous auto injector for use with AMAG’s progestin hormone drug ® ® drug-device combination product, which is a ready-to-administer treatment indicated to reduce the risk of preterm birth in women pregnant with one baby and who spontaneously delivered one preterm baby in the past. The Company is developing XYOSTED TM TM |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements include the accounts of Antares Pharma, Inc. and its two wholly-owned foreign subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Use of Estimates The preparation of consolidated financial statements in conformity with U.S. generally accepted accounting principles 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 financial statements and the reported amounts of revenues and expenses during the reporting period. The Company’s significant accounting estimates relate to revenue recognition, inventory valuation, valuation of equity instruments used in stock-based compensation, and determination of the fair value and recoverability of long-lived assets including intangibles and goodwill. Actual results could differ from these estimates. Foreign Currency Translation The majority of the foreign subsidiaries’ revenues are denominated in U.S. dollars, and any required funding of the subsidiaries is provided by the U.S. parent. Nearly all operating expenses of the foreign subsidiaries are denominated in Swiss Francs. Additionally, bank accounts held by foreign subsidiaries are denominated in Swiss Francs, there is a low volume of intercompany transactions and there is not an extensive interrelationship between the operations of the subsidiaries and the parent company. As such, the Company has determined that the Swiss Franc is the functional currency for its foreign subsidiaries. The reporting currency for the Company is the United States Dollar (“USD”). The financial statements of the Company’s foreign subsidiaries are translated into USD for consolidation purposes. All assets and liabilities are translated using period-end exchange rates and statements of operations items are translated using average exchange rates for the period. The resulting translation adjustments are recorded as a separate component of stockholders’ equity, comprising all of the accumulated other comprehensive income (loss). Sales to certain customers and purchases from certain vendors by the U.S. parent are in currencies other than the U.S. dollar and are subject to foreign currency exchange rate fluctuations. Foreign currency transaction gains and losses are included in foreign exchange gain (loss) in the consolidated statements of operations. Cash and Cash Equivalents Cash consists of demand deposits at commercial banks. The Company also invests in cash equivalents consisting of highly liquid investments in money market funds with original maturities of three months or less. Investments The Company’s investments consist of U.S. Treasury bills and government agency notes that are classified as held-to-maturity because the Company has the intent and ability to hold the securities to maturity. Investments with maturities of one year or less are classified as short-term. The securities are carried at their amortized cost and the fair value is determined by quoted market prices. At December 31, 2017, the Company’s short-term investments had a carrying value of $4,993, which approximated fair value. The Company held no investments as of December 31, 2016. Accounts Receivable and Allowance for Doubtful Accounts Trade accounts receivable are stated at the amount the Company expects to collect. The Company considers the following factors when determining the collectability of specific customer accounts: customer credit-worthiness, past transaction history with the customer, current economic industry trends, and changes in customer payment terms. At December 31, 2017, the Company’s accounts receivable balance was due primarily from Teva, AMAG and distributors of OTREXUP ® Inventories Inventories are stated at the lower of cost or net realizable value. Cost is determined on a first-in, first-out basis. Certain components of the Company’s products are provided by a limited number of vendors, and the Company’s production and assembly operations are outsourced to third-party suppliers where substantially all of the Company’s inventory is located. Disruption of supply from key vendors or third-party suppliers may have a material adverse impact on the Company’s operations. Inventory consists of the following: December 31, December 31, 2017 2016 Raw material $ 118 $ 143 Work in process 6,223 2,429 Finished goods 2,934 2,755 $ 9,275 $ 5,327 The Company provides reserves for potentially excess, dated or obsolete inventories based on estimates of forecasted product demand and the likelihood of consumption in the normal course of business, considering the expiration dates of the inventories on hand, planned production volumes and lead times required for restocking of customer inventories. Although every effort is made to ensure that forecasts and assessments are reasonable, changes to these assumptions are possible. In such cases, estimates may prove inaccurate and result in an understatement or overstatement of the reserves required to fairly state such inventories. The Company’s reserve for excess, dated or obsolete inventory was $510 and $900 at December 31, 2017 and 2016, respectively. In 2017, the Company wrote off inventory of $746 and increased the reserve for excess, dated or obsolete inventory by $356. In 2016, the Company wrote off $648 of inventory and increased the reserve for excess, dated or obsolete inventory by $748. Equipment, Molds, Furniture, and Fixtures Equipment, molds, furniture, and fixtures are stated at cost and are depreciated using the straight-line method over their estimated useful lives ranging from three to ten years. The Company’s equipment, molds, furniture and fixtures consisted of the following: December 31, December 31, 2017 2016 Furniture, fixtures and office equipment $ 2,258 $ 2,234 Production molds and equipment 15,322 10,582 Molds and tooling in process 4,023 10,150 Less accumulated depreciation (5,445 ) (5,099 ) $ 16,158 $ 17,867 Depreciation expense was $1,536, $1,326 and $1,034 for the years ended December 31, 2017, 2016 and 2015, respectively. In 2017, the Company sold certain assets, including molds and equipment, to Ferring, the net book value of which was $933. Patent Rights The Company capitalizes the costs of obtaining patent rights when there are projected future cash flows for marketed or partnered products associated with the patent. These capitalized costs are being amortized on a straight-line basis over the shorter of the life of the patent or the estimated useful life of the patent, which typically is over periods ranging from five to fifteen years beginning on the earlier of the date the patent is issued or the first commercial sale of product utilizing such patent rights. The Company periodically reviews capitalized patent costs to identify any amounts to be charged to expense for patents that are no longer being pursued or for which there are no future revenues or cash flows anticipated. The Company capitalizes external legal patent defense costs and costs for pursuing patent infringements when it determines that a successful outcome is probable and will lead to an increase in the value of the patent. The capitalized costs are amortized over the remaining life of the related patent. If changes in the anticipated outcome were to occur that reduce the likelihood of a successful outcome of the entire action to less than probable, the capitalized costs would be charged to expense in the period in which the change is determined. The gross carrying amount and accumulated amortization of patents was $3,772 and $2,371, respectively at December 31, 2017, and $4,659 and $2,614, respectively, at December 31, 2016. Patent amortization expense for the years ended December 31, 2017, 2016 and 2015 was $568, $534 and $536, respectively, and is recorded in selling, general and administrative expenses in the consolidated statements of operations. The Company’s estimated aggregate patent amortization expense for the next five years is $574, $327, $70, $57 and $47 in 2018, 2019, 2020, 2021 and 2022, respectively. In 2017, the Company sold certain assets, including patent rights, to Ferring. The net book value of the patents sold was $108. In 2017 and 2015, the Company expensed $46 and $31, respectively of capitalized patent costs for abandoned patents or patents no longer connected with current products. There was no write-off of patent costs in 2016. Impairment of Long-Lived Assets and Intangibles Long-lived assets and intangibles, including patent rights, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset or asset group. This analysis can be very subjective; however, the Company utilizes the expected future undiscounted cash flows from signed license and distribution agreements and other contracts with customers to substantiate the recoverability of its long-lived assets. If the sum of the undiscounted cash flows is less than the carrying value of the asset, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. Assets to be disposed of are reported at the lower of the carrying amount or fair value less costs to sell. Goodwill Goodwill is evaluated for impairment annually at December 31, or more frequently if an event occurs or circumstances change that indicate that the carrying value may not be recoverable. In performing the annual impairment test, the Company compares the fair value of the reporting unit to the carrying amount and would recognize an impairment charge to goodwill for the amount by which the carrying amount exceeds the reporting unit’s fair value. At December 31, 2017 and 2016, the Company had goodwill with a carrying value of $1,095, attributable to its single reporting unit. Based on the results of its evaluations, the Company determined that goodwill was not impaired, and no impairment losses were recognized in the years ended December 31, 2017, 2016, and 2015, respectively. Fair Value of Financial Instruments The carrying value of certain of the Company’s financial instruments, including accounts receivable and accounts payable, approximate fair value due to the short-term nature of the instruments. From time to time, the Company invests in U.S. Treasury bills or U.S. Treasury notes that are classified as held-to-maturity because the Company has the positive intent and ability to hold the securities to maturity. The investment securities are carried at amortized cost and fair value is determined by quoted market prices, which is a Level 1 fair value measurement. At December 31, 2017, the fair value of the Company’s short-term investments approximated the carrying values and no short-term investments were held at December 31, 2016. Revenue Recognition The Company recognizes revenue from the sale of products, development project milestones, license fees and royalties. Revenue is recognized when all of the following criteria are met: persuasive evidence of the arrangement exists; delivery has occurred and we have no remaining obligations; the fee is fixed or determinable; and collectability is reasonably assured. OTREXUP ® The Company began detailing OTREXUP ® ® Prior to the first quarter of 2017, the Company could not reliably estimate expected returns of OTREXUP ® ® In the first quarter of 2017, the Company determined it had developed sufficient historical information to reasonably estimate potential returns of OTREXUP ® Product sales revenue for OTREXUP ® Product Sales Allowances The Company recognizes product sales allowances as a reduction of product sales in the same period the related revenue is recognized. Product sales allowances are based on amounts owed or to be claimed on the related sales. These estimates take into consideration the terms of our agreements with customers and third-party payers and the levels of inventory within the distribution channels that may result in future rebates or discounts taken. In certain cases, such as patient support programs, the Company recognizes the cost of patient discounts as a reduction of revenue based on estimated utilization. If actual future results vary, it may be necessary to adjust these estimates, which could have an effect on product revenue in the period of adjustment. Product sales allowances include: Wholesaler Distribution Fees . Distribution fees are paid to certain wholesale distributors based on contractually determined rates. The Company accrues the fee on shipment to the respective wholesale distributors and recognizes the fee as a reduction of revenue in the same period the related revenue is recognized. Prompt Pay Discounts . The Company offers cash discounts to its customers, generally 2% of the sales price, as an incentive for prompt payment. The Company accounts for cash discounts by reducing accounts receivable by the prompt pay discount amount and recognizes the discount as a reduction of revenue in the same period the related revenue is recognized. Chargebacks . The Company provides discounts primarily to authorized users of the Federal Supply Schedule (“FSS”) of the General Services Administration under an FSS contract negotiated by the Department of Veterans Affairs and various organizations under Medicaid contracts and regulations. These entities purchase products from the wholesale distributors at a discounted price, and the wholesale distributors then charge back to the Company the difference between the current wholesale acquisition cost and the price the entity paid for the product. The Company will estimate and accrue chargebacks based on estimated wholesaler inventory levels, current contract prices and historical chargeback activity. Chargebacks are recognized as a reduction of revenue in the same period the related revenue is recognized. Rebates . The Company participates in certain rebate programs, which provide discounted prescriptions to qualified insured patients. Under these rebate programs, the Company will pay a rebate to the third-party administrator of the program, generally two to three months after the quarter in which prescriptions subject to the rebate are filled. The Company estimates and accrues for these rebates based on current contract prices, historical and estimated future percentages of product sold to qualified patients. Rebates are recognized as a reduction of revenue in the same period the related revenue is recognized. Patient Discount Programs. The Company offers discount card programs to patients for OTREXUP ® Sumatriptan Revenue Recognition Under a license, supply and distribution agreement with Teva for an auto-injector product containing sumatriptan, the Company produces devices and assembles final product for shipment to Teva, and Teva is responsible for commercial distribution and sale of the product. The Company is compensated, and recognizes revenue, at cost for shipments of product delivered to Teva. The Company is also entitled to receive 50 percent of the net profits from commercial sales made by Teva, payable to the Company within 45 days after the end of the quarter in which the commercial sales are made. Sumatriptan Injection USP was launched for commercial sale in June 2016. Initially, given the limited access to sales data and the 45-day lag in reporting of the profit split from Teva, management was not able to estimate the profit margin the Company expected to receive from commercial sales made by Teva at the time of sale. Accordingly, prior to the third quarter of 2017, revenue from the profit sharing arrangement was recognized in the period following the commercial sales by Teva when amounts were reported and paid to the Company. Beginning in the third quarter of 2017, management determined it had developed sufficient history and is now able to obtain additional sales information in order to reasonably estimate and recognize revenue from the profit sharing arrangement when product is sold by Teva. The change in estimation and recognition had no material impact on the Company’s consolidated financial statements. Other Revenue Recognition The Company sells reusable needle-free injectors and related disposable products to pharmaceutical partners. The reusable injectors and related disposable products are not interchangeable with any competitive products and must be used together. The Company recognizes revenue upon shipment when title transfers. The Company offers no price protection or return rights other than for customary warranty claims. Sales terms and pricing are governed by license and distribution agreements. Revenue arrangements with multiple deliverables are divided into separate units of accounting if certain criteria are met, including whether the deliverable has stand-alone value to the customer, the customer has a general right of return relative to the delivered item and delivery or performance of the undelivered item is probable and substantially within the vendor’s control. Arrangement consideration is allocated at the inception of the arrangement to all deliverables on the basis of their relative selling price. The selling price for each deliverable is determined using: (i) vendor-specific objective evidence of selling price (“VSOE”), if it exists, (ii) third-party evidence of selling price (“TPE”) if VSOE does not exist, and (iii) the Company’s best estimate of the selling price if neither VSOE nor TPE exists. Revenue, excluding variable consideration, is recognized upon completion of deliverables based on the relative selling price of each deliverable that was assigned at inception of the arrangement. Royalty revenue is recognized in the period in which it is earned when the Company has sufficient information to determine its quarterly royalty earnings to be received from partners. Share-Based Compensation The Company utilizes share based compensation in the form of stock options, restricted stock units (“RSUs”) and performance-based restricted stock units (“PSUs”). The Company records compensation expense associated with share based awards granted to employees at the fair value of the award on the date of grant. The Company uses the Black-Scholes option valuation model to determine the fair value of stock options. The fair values of RSU and PSU grants containing service or performance conditions are based on the market value of the Company’s Common Stock on the date of grant. The fair value of PSUs containing a market condition are estimated using a Monte Carlo simulation. The value of the portion of the award that is ultimately expected to vest is expensed ratably over the requisite service period as compensation expense in the consolidated statement of operations. Forfeitures are recorded as incurred. Assumptions concerning the Company’s stock price volatility and projected employee exercise behavior over the contractual life of the award can significantly impact the estimated fair value of an award. Product Warranty The Company provides a warranty on its reusable needle-free injector devices. The warranty period on a needle-free injector device is typically 24 months from either the date of retail sale of the device by a dealer or distributor or the date of shipment to a customer if specified by contract. The Company recognizes the estimated cost of warranty obligations at the time the products are shipped based on historical claims incurred by the Company. Actual warranty claim costs could differ from these estimates. The Company had $50 and $100 in warranty liability reserves as of December 31, 2017 and 2016, respectively. Research and Development Research and development expenses include costs directly attributable to the conduct of research and development programs including personnel costs, materials and supplies associated with design work and prototype development, FDA fees and the cost of services provided by outside contractors such as expenses related to clinical trials. All costs associated with research and development activities are expensed as incurred. Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. On December 22, 2017, the President of the United States signed into law the Tax Cuts and Jobs Act (“TCJA”). This legislation makes broad and complex changes to the U.S. tax code. The U.S. Securities and Exchange Commission (“SEC”) staff issued guidance on accounting for the tax effects of TCJA under Staff Accounting Bulletin No. 118 (“SAB 118”). SAB 118 provides a one-year measurement period for companies to complete its accounting for the tax effects of TCJA. The Company calculated its best estimate of the impact of the TCJA based on its understanding of the TCJA and guidance available as of the filing date and recorded provisional amounts as of December 31, 2017. U.S. Treasury regulations, administrative interpretations or court decisions interpreting the TCJA may require changes in these estimates. The final determination of the effects of the TCJA will be completed as additional information becomes available, but no later than one year from the enactment of the TCJA. Any subsequent adjustment to the estimated amounts is not expected to be material to the financial statements. Net Loss Per Share Basic net loss per share is computed by dividing net income or loss available to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed similar to basic net loss per share except that the weighted average shares outstanding are increased to include additional shares from the assumed exercise of stock options and warrants, if dilutive. The number of additional shares is calculated by assuming that outstanding stock options or warrants were exercised and that the proceeds from such exercise were used to acquire shares of common stock at the average market price during the reporting period. All potentially dilutive common shares were excluded from the calculation because they were anti-dilutive for all periods presented. Potentially dilutive securities excluded from dilutive loss per share were 14,761,442, 13,483,856 and 11,151,503 at December 31, 2017, 2016 and 2015, respectively. Segment Information Operating segments are components of an enterprise for which separate financial information is available and is evaluated regularly by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company’s chief operating decision maker currently evaluates the Company’s operations as a whole from a number of different operational perspectives, including but not limited to, on a product-by-product, customer and partner basis. The Company derives all significant revenues from self-administered parenteral pharmaceutical products and technologies, and has a single reportable operating segment of business. Accordingly, the Company does not report more than one segment; nevertheless, management periodically evaluates whether the Company continues to have one single reportable segment of business. Going Concern Management is responsible for evaluating, and providing disclosure of uncertainties about, the Company’s ability to continue as a going concern. As of December 31, 2017, the Company had cash, cash equivalents and short-term investments of $31,555. Based on management’s evaluation, management concluded there is no substantial doubt or uncertainty about the Company’s ability to meet its obligations within one year from the date the financial statements were issued. Accounting Pronouncements Recently Adopted In July 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2015-11, Simplifying the Measurement of Inventory In March 2016, the FASB issued ASU No. 2016-09, Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting “ In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business (“ASU 2017-01”), which provides additional clarification to aid in determining when a set of assets and activities is not a business, and In January 2017, the FASB issued ASU 2017-04, Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment Recent Accounting Pronouncements Not Yet Adopted In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers The Company has reviewed all of its major contracts with customers and has adopted the new revenue recognition standard effective January 1, 2018 utilizing the modified retrospective method of adoption. The adoption of ASU No. 2014-09 did not have a material impact on the Company’s consolidated financial statements. No significant changes to business processes or systems have been necessary. In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) In May 2017, the FASB issued ASU No. 2017-09, Compensation – Stock Compensation (Topic 718): Scope of Modification Accounting In May 2017, the FASB issued ASU No. 2017-05, Other Income – Gains and Losses from the Derecognition of Nonfinancial Assets (Subtopic 610-20): Clarifying the Scope of Asset Derecognition Guidance and Accounting for Partial Sales of Nonfinancial Assets |
Sale of Assets
Sale of Assets | 12 Months Ended |
Dec. 31, 2017 | |
Sale Of Assets [Abstract] | |
Sales of Assets | 3. Sale of Assets In October 2017, the Company entered into an asset purchase agreement (the “Asset Purchase Agreement”) with Ferring to sell the worldwide rights, including certain assets, related to the ZOMAJET™ needle-free auto injector device product line for a total purchase price of $14.5 million. The purchase price is to be paid in four installments consisting of the following: a $2.0 million upfront payment, which was received upon entry into the Asset Purchase Agreement and the transfer of certain assets; a second installment of $2.75 million received upon delivery of certain documentation and satisfaction of certain conditions primarily related to product manufacturing, which occurred in February 2018; a third installment of $4.75 million payable upon satisfaction of certain conditions, including further document transfer, the successful completion of a regulatory audit by a notified body, and a pilot manufacturing run under Ferring’s supervision; and a final installment of $5.0 million upon Ferring’s receipt of the CE Mark needed to continue to commercialize the product in certain territories and the final transfer of certain product-related inventory, equipment and agreements to Ferring (the “Completion Date”), which is expected to occur by the end of 2018. For the year ended December 31, 2017, the Company recorded a gain on sale of assets upon receipt of the non-refundable upfront payment from Ferring and transfer of certain manufacturing equipment and patents as follows: Proceeds from sale of assets $ 2,000 Less: Net book value of molds and equipment transferred 933 Net book value of patents transferred 108 Payment of transaction costs 99 Gain on sale of assets $ 860 The Company will continue to manufacture and supply needle-free devices until the Completion Date and will receive payment for devices manufactured and supplied to its partners, and a royalty on net product sales, in accordance with the existing license and supply agreements. |
Long-Term Debt
Long-Term Debt | 12 Months Ended |
Dec. 31, 2017 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | 4 . Long-Term Debt In June 2017, the Company entered into a loan and security agreement (the “Loan Agreement”) with Hercules Capital, Inc., for a term loan of up to $35.0 million (the “Term Loan”), the proceeds of which are to be used for working capital and general corporate purposes. The first advance of $25.0 million was funded upon execution of the Loan Agreement in June 2017. Under the terms of the Loan Agreement, the Company may, but is not obligated to, request one or more additional advances of at least $5.0 million not to exceed $10.0 million in the aggregate, subject to the Company achieving certain corporate milestones and satisfying customary conditions. The Company must achieve certain corporate milestones and exercise its option to request additional advances prior to September 30, 2018. The Term Loan is secured by substantially all of the Company’s assets, excluding intellectual property, and will mature on July 1, 2022. The Term Loan accrues interest at a calculated prime-based variable rate with a maximum interest rate of 9.50%. As of December 31, 2017, the interest rate was 8.75%. Payments under the Loan Agreement are interest only until the first principal payment is due on August 1, 2019, provided that the interest only period may be extended to February 1, 2020 if the Company achieves certain corporate milestones. The corporate milestones must be achieved, and the option to request additional advances must be exercised, prior to September 30, 2018, which is currently unlikely to occur. The Loan Agreement also requires the Company to pay a fee equal to 4.25% of the total original principal amount of all term loan advances (“End of Term Charge”), which is due upon repayment of the Term Loan at either maturity or earlier repayment, and imposes a prepayment fee of 1.0% to 3.0% if any or all of the balance is prepaid prior to the maturity date. As of December 31, 2017, the carrying value of the Term Loan was $24,858, which consisted of the $25,000 principal balance outstanding and the End of Term Charge accrual of $119, less unamortized debt issuance costs of $261. The Company incurred debt issuance costs that, along with the End of Term Charge, are being amortized/accrued to interest expense over the term of the Term Loan using the effective interest method. The Company paid $1,080 in interest for the year ended December 31, 2017. Future principal payments under the term loan, including the End of Term Charge, are as follows: 2018 $ — 2019 3,065 2020 7,857 2021 8,610 2022 6,531 $ 26,063 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2017 | |
Equity [Abstract] | |
Stockholders' Equity | 5. Stockholders’ Equity In August 2017, the Company entered into a sales agreement (the “Sales Agreement”) with Cowen and Company, LLC (“Cowen”) under which the Company may offer and sell, from time to time and at its sole discretion, shares of its common stock having an aggregate offering price of up to $30.0 million through Cowen as the Company’s sales agent and/or as principal. Cowen may sell the common stock by any method permitted by law deemed to be an “at the market offering” as defined in Rule 415 of the Securities Act of 1933, as amended. The Company will pay Cowen a commission of 3.0% of the gross sales proceeds of any common stock sold through Cowen under the Sales Agreement. The Company is not obligated to make any sales of common stock under the Sales Agreement and no sales of common stock were made pursuant to the Sales Agreement in the period ended December 31, 2017. On May 11, 2015, the Company completed an underwritten offering of 23,000,000 shares of its common stock at a price to the public of $2.00 per share. The Company received net proceeds of $42.9 million after deducting underwriting discounts, commissions and offering expenses paid by the Company. The Company has used the net proceeds from the offering for general corporate purposes including research and development activities. |
Share Based Compensation
Share Based Compensation | 12 Months Ended |
Dec. 31, 2017 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share Based Compensation | 6. Share-Based Compensation The Company’s 2008 Equity Compensation Plan (the “Plan”) was amended and restated pursuant to stockholder approval in June 2016 in order to increase the number of shares available for issuance under the Plan, extend the term of the Plan, impose a one-year minimum vesting requirement and provide for double trigger accelerated vesting for certain awards in the event of a change in control. The Plan allows for grants in the form of incentive stock options, nonqualified stock options, stock units, stock awards, stock appreciation rights, and other stock-based awards. All of the Company’s officers, directors, employees, consultants and advisors are eligible to receive grants under the Plan. Under the Plan, the maximum number of shares authorized for issuance is 32,200,000 and the maximum number of shares of stock that may be granted to any one participant during a calendar year is 4,000,000 shares. Options to purchase shares of common stock are granted at exercise prices not less than 100% of fair market value on the dates of grant. The term of each option is 10 years and the options typically vest in quarterly installments over a three-year period. As of December 31, 2017, the Plan had approximately 6,500,000 shares available for grant. Stock option exercises are satisfied through the issuance of new shares. Stock Options Stock option activity under the Plan as of and for the three years ended December 31, 2017 is as follows: Weighted Weighted Average Average Remaining Aggregate Number of Exercise Contractual Intrinsic Shares Price ($) Term (Years) Value ($) Outstanding at December 31, 2014 7,245,485 2.25 Granted/Issued 2,984,010 2.23 Exercised (20,000 ) 1.54 — Cancelled/Forfeited (728,998 ) 2.92 Outstanding at December 31, 2015 9,480,497 2.19 Granted/Issued 4,029,500 1.14 Exercised (142,493 ) 1.23 122 Cancelled/Forfeited (2,053,595 ) 2.13 Outstanding at December 31, 2016 11,313,909 1.84 Granted/Issued 2,985,667 2.67 Exercised (1,311,293 ) 1.38 2,226 Cancelled/Forfeited (839,455 ) 2.68 Outstanding at December 31, 2017 12,148,828 2.04 7.1 4,206 Exercisable at December 31, 2017 8,443,947 1.99 6.3 3,201 As of December 31, 2017, there was $3,793 of total unrecognized compensation costs related to nonvested outstanding stock options that are expected to be recognized over a weighted average period of approximately 1.9 years. Stock option expense recognized in 2017, 2016 and 2015 was $2,378, $2,039 and $2,883, respectively. The per share weighted average fair value of options granted during 2017, 2016 and 2015 was estimated as $1.37, $0.57 and $1.13, respectively, on the date of grant using the Black-Scholes option pricing model based on the assumptions noted in the table below. Expected volatilities are based on the historical volatility of the Company’s stock. The weighted average expected life is based on both historical and anticipated employee behavior. December 31, 2017 2016 2015 Risk-free interest rate 1.8 % 1.3 % 1.3 % Annualized volatility 53.3 % 51.7 % 53.5 % Weighted average expected life, in years 6.0 6.0 6.0 Expected dividend yield 0.0 % 0.0 % 0.0 % Option exercises during 2017, 2016 and 2015 resulted in proceeds of $1,816, $101 and $31, respectively, and in the issuance of shares of common stock of 1,311,293 in 2017, 102,776 in 2016 and 20,000 in 2015. In 2016, certain options were net exercised, whereby the Company withheld 39,717 shares, the fair value of which was equivalent to the aggregate exercise price and tax withholding on the date of exercise. Long Term Incentive Program The Company’s Board of Directors has approved a long term incentive program (“LTIP”) for the benefit of the Company’s senior executives. Pursuant to the LTIP, the Company’s senior executives are awarded stock options, restricted stock units (“RSU”) and performance stock units (“PSU”) with targeted values based on similar award structures granted by the Company’s peer group. The stock options have a ten-year term, have an exercise price equal to the closing price of the Company’s common stock on the date of grant, vest in quarterly installments over three years, were otherwise granted on the same standard terms and conditions as other stock options granted pursuant to the Plan and are included in the stock options table above. The RSUs vest in three equal annual installments, and the PSU awards vest and convert into shares of the Company’s common stock based on the Company’s attainment of certain performance goals over a performance period, which is typically three to five years. The performance stock unit awards and restricted stock unit awards granted under the long term incentive program are summarized in the following table: Performance Stock Units Restricted Stock Units Number of Shares Weighted Average Date Fair Value ($) Number of Shares Weighted Average Grant Date Fair Value ($) Outstanding at December 31, 2014 463,542 3.08 231,124 3.07 Granted 664,391 2.09 664,391 2.18 Vested/settled — (112,285 ) 2.92 Forfeited/expired (171,755 ) 2.69 (68,402 ) 2.47 Outstanding at December 31, 2015 956,178 2.40 714,828 2.32 Granted 750,500 1.15 750,500 1.12 Vested/settled (16,835 ) 3.96 (264,001 ) 2.41 Forfeited/expired (342,554 ) 2.17 (378,669 ) 1.91 Outstanding at December 31, 2016 1,347,289 1.50 822,658 1.39 Granted 689,180 3.12 689,180 2.69 Vested/settled — (287,508 ) 1.49 Forfeited/expired (580,721 ) 2.16 (67,464 ) 1.70 Outstanding at December 31, 2017 1,455,748 2.20 1,156,866 2.12 In each of the years in the three-year period ended December 31, 2017, the LTIP awards include PSUs that will be earned based on the Company’s total shareholder return (“TSR”) as compared to the Nasdaq Biotechnology Index (“NBI”) at the end of the respective annual performance periods. Depending on the outcome of the performance goal, a recipient may ultimately earn a number of shares greater or less than their target number of shares granted, ranging from 0% to 150% of the PSUs granted. The fair values of the TSR PSUs granted were determined using a Monte Carlo simulation and utilized the following inputs and assumptions: 2017 Award 2016 Award 2015 Award Closing stock price on grant date $ 2.66 $ 1.12 $ 2.18 Performance period starting price $ 2.17 $ 1.29 $ 2.52 Term of award (in years) 2.57 2.58 2.59 Volatility 54.6 % 70.1 % 60.5 % Risk-free interest rate 1.39 % 0.97 % 0.83 % Expected dividend yield 0.00 % 0.00 % 0.00 % Fair value per TSR PSU $ 3.10 $ 1.25 $ 1.71 The performance period starting price is measured as the average closing price over the last 20 trading days prior to the performance period start. The Monte Carlo simulation model also assumed correlations of returns of the prices of the Company’s common stock and the common stocks of the NBI companies and stock price volatilities of the NBI companies. The fair value of the target number of shares that can be earned under the TSR PSUs is being recognized as compensation expense over the term of the award. In connection with PSU awards, including both TSR based awards and awards with defined performance goals considered probable of achievement, the Company recognized total compensation expense of $411, $68 and $250 in 2017, 2016 and 2015, respectively. Compensation expense recognized in 2017, 2016 and 2015 in connection with the RSUs was $701, $413 and $526, respectively. In 2017, 2016 and 2015, a portion of the LTIP awards were net-share settled such that the Company withheld shares with value equivalent to the employees’ minimum statutory obligation for the applicable income and other employment taxes, and remitted the cash to the appropriate taxing authorities. The total shares withheld were 97,586, 73,888 and 39,665 in 2017, 2016 and 2015, respectively, and were based on the value of the shares on their vesting date as determined by the Company’s closing stock price. Total payments for the employees’ tax obligations to the taxing authorities were $249, $84 and $88 in 2017, 2016 and 2015, respectively, and are reflected as a financing activity within the Consolidated Statements of Cash Flows. These net-share settlements reduced the number of shares that would have otherwise been issued as a result of the vesting and did not represent an expense to the Company. |
Accrued Expenses and Other Liab
Accrued Expenses and Other Liabilities | 12 Months Ended |
Dec. 31, 2017 | |
Payables And Accruals [Abstract] | |
Accrued Expenses and Other Liabilities | 7. Accrued Expenses and Other Liabilities Accrued expenses and other liabilities consisted of the following: December 31, December 31, 2017 2016 Accrued expenses and other liabilities: Accrued employee compensation and benefits $ 2,470 $ 2,703 OTREXUP ® 2,140 1,484 Other liabilities 2,372 1,686 $ 6,982 $ 5,873 |
Employee 401(k) Savings Plan
Employee 401(k) Savings Plan | 12 Months Ended |
Dec. 31, 2017 | |
Compensation And Retirement Disclosure [Abstract] | |
Employee 401(k) Savings Plan | 8 . Employee 401(k) Savings Plan The Company sponsors a 401(k) defined contribution retirement savings plan that covers all U.S. employees who have met minimum age and service requirements. Under the plan, eligible employees may contribute up to 50% of their annual compensation into the plan up to the IRS annual limits. The Company makes elective contributions to the plan allocated in proportion to employee contributions. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2017 | |
Leases [Abstract] | |
Leases | 9. Leases The Company has non-cancellable operating leases for its corporate headquarters facility in Ewing, New Jersey, and its office, research and development facility in Plymouth, Minnesota, a suburb of Minneapolis. The leases require payment of all executory costs such as maintenance and property taxes. The company also leases office equipment under short-term operating leases. Rent expense incurred for the years ended December 31, 2017, 2016 and 2015 was $656, $680 and $672, respectively. Future minimum lease payments under operating leases with remaining terms in excess of one year as of December 31, 2017 were as follows: Amount 2018 $ 623 2019 566 2020 233 2021 238 2022 60 Thereafter — Total future minimum lease payments $ 1,720 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 10. Income Taxes On December 22, 2017, the President of the United States signed into law the Tax Cuts and Jobs Act (the “TCJA”). This legislation makes broad and complex changes to the U.S. tax code, including, but not limited to, (i) reducing the U.S. federal statutory tax rate from a maximum of 35% to 21%; (ii) eliminating the corporate alternative minimum tax (AMT) and changing how existing AMT credits can be realized; (iii) changing rules related to uses and limitations of net operating loss carryforwards created in tax years beginning after December 31, 2017, (iv) limitations on the deductibility of interest expense and executive compensation; (v) creation of new minimum taxes such as the base erosion anti-abuse tax (“BEAT”) and Global Intangible Low Taxed Income (“GILTI”); and (vi) the transition of U.S. international taxation from a worldwide tax system to a modified territorial tax system, which requires a one-time U.S. tax liability on earnings which have not previously been repatriated to the U.S. (“transition tax”). The Company calculated its best estimate of the impact of the TCJA based on its understanding of the TCJA and guidance available as of the filing date and recorded provisional amounts as of December 31, 2017. As a result of the corporate tax rate decreasing to 21%, the Company recorded a provisional estimate of a reduction to its deferred tax assets of $24,196 and a corresponding reduction to its valuation allowance. Because the Company’s foreign entities are in an accumulated earnings deficit, the Company estimates that there will be no one-time transition tax liability. The Company has not completed its accounting for the potential taxes imposed by BEAT, GILTI and executive compensation; however, the potential income tax impact, if any, will be recorded as a component of tax expense in the period incurred for tax year(s) beginning January 1, 2018 and forward. U.S. Treasury regulations, administrative interpretations or court decisions interpreting the TCJA may require changes in our estimates. The final determination of the effects of the TCJA will be completed as additional information becomes available, but no later than one year from the enactment of the TCJA. Any subsequent adjustment to the estimated amounts is not expected to be material to the financial statements. The Company was subject to taxes in both the U.S. and Switzerland in each of the years in the three-year period ended December 31, 2017. The Company incurred losses for both book and tax purposes for the year ended December 31, 2017, and, accordingly, no income taxes were provided. Income (loss) before income taxes was derived from the following jurisdictions: 2017 2016 2015 U.S. $ (16,762 ) $ (24,229 ) $ (21,831 ) Switzerland 19 (10 ) 1,347 $ (16,743 ) $ (24,239 ) $ (20,484 ) Effective tax rates differ from statutory income tax rates in the years ended December 31, 2017, 2016 and 2015 as follows: 2017 2016 2015 Statutory income tax rate (34.0 )% (34.0 )% (34.0 )% State income taxes (6.1 ) (6.8 ) (5.7 ) Valuation allowance increase (102.0 ) 35.9 35.2 Effect of foreign operations — — (1.3 ) Change in unused net operating loss and credit carryforwards (4.0 ) 3.7 2.8 Nondeductible items 1.6 1.6 3.9 Impact of Tax Cuts and Jobs Act 144.5 — — 0.0 % 0.4 % 0.9 % Deferred tax assets (liabilities) as of December 31, 2017 and 2016 consist of the following: 2017 2016 Gross deferred tax assets: Net operating loss carryforward – U.S. $ 43,046 $ 58,206 Net operating loss carryforward – Switzerland 67 65 Research and development tax credit carryforward 6,153 5,477 Deferred revenue 339 438 Stock-based compensation 1,882 2,678 Inventory reserve 140 364 Compensation accruals 662 996 Other 575 378 52,864 68,602 Gross deferred tax liabilities – depreciation and amortization (826 ) (844 ) Less valuation allowance (52,038 ) (67,758 ) Net deferred tax asset $ — $ — The valuation allowance for deferred tax assets as of December 31, 2017 and 2016 was $52,038 and $67,758, respectively. The total valuation allowance decreased $15,720 for the year ended December 31, 2017 and increased $8,864 for the year ended December 31, 2016. At both December 31, 2017 and 2016, the Company had deferred tax assets, net of valuation allowances, of zero. In assessing the realizability of deferred tax assets, management considered whether it is more likely than not that some portion or 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 temporary differences become deductible or in which net operating loss or tax credit carryforwards can be utilized. Both positive and negative evidence is considered in assessing the realizability of deferred tax assets and determining whether or not to record a valuation allowance. After considering the evidence with respect to the U.S. deferred tax assets, management determined that as of December 31, 2017, it continues to be more likely than not that the U.S. deferred tax assets will not be realized and has recorded a valuation allowance against all U.S. deferred tax assets. The Company has a U.S. federal net operating loss carryforward at December 31, 2017 of $176,069, which, subject to limitations of Internal Revenue Code (“IRC”) Section 382, is available to reduce income taxes payable in future years. If not used, this carryforward will expire in years 2018 through 2037. Additionally, the Company has research credit carryforwards of $5,617. These credits expire in years 2018 through 2037. Utilization of U.S. net operating losses and tax credits of the Company may be subject to annual limitations under IRC Sections 382 and 383, respectively. The annual limitations, if any, have not yet been determined. When a review is performed and if any annual limitations are determined, then the gross deferred tax assets for the net operating losses and tax credits would be reduced with a reduction in the valuation allowance of a like amount. The Company also has a Swiss net operating loss carryforward at December 31, 2017, of $454, which is available to reduce income taxes payable in future years. If not used, $428 of this carryforward will expire in 2018. As of December 31, 2017 and 2016, there were no unrecognized tax benefits. Accordingly, a tabular reconciliation from beginning to ending periods is not provided. The Company will classify any future interest and penalties as a component of income tax expense if incurred. To date, there have been no interest or penalties charged or accrued in relation to unrecognized tax benefits. The Company does not anticipate that the total amount of unrecognized tax benefits will change significantly in the next twelve months. The Company is subject to federal and state examinations for the years 2013 and thereafter. There are no tax examinations currently in progress. |
Significant Customers and Conce
Significant Customers and Concentrations of Risk | 12 Months Ended |
Dec. 31, 2017 | |
Risks And Uncertainties [Abstract] | |
Significant Customers and Concentrations of Risk | 11. Significant Customers and Concentrations of Risk Revenues by customer geographic location are summarized as follows: For the Years Ended December 31, 2017 2016 2015 United States of America $ 48,924 $ 45,531 $ 39,229 Europe 5,061 6,117 6,026 Other 530 574 403 $ 54,515 $ 52,222 $ 45,658 Significant customers from which the Company derived 10% or more of its total revenue in any of the periods presented are as follows: For the Years Ended December 31, 2017 2016 2015 Teva $ 20,949 $ 24,941 $ 17,715 AMAG 8,965 4,446 365 McKesson (1) 8,707 7,600 6,837 AmerisourceBergen (1) 6,098 4,903 4,527 Ferring 5,258 6,283 6,117 LEO Pharma — — 6,000 (1) Revenue net of estimated sales returns and allowances based on OTREXUP ® |
Legal Proceedings
Legal Proceedings | 12 Months Ended |
Dec. 31, 2017 | |
Commitments And Contingencies Disclosure [Abstract] | |
Legal Proceedings | 12. Legal Proceedings Pending Litigation On October 23, 2017, Randy Smith filed a complaint in the District of New Jersey, captioned Randy Smith, Individually and on Behalf of All Others Similarly Situated v. Antares Pharma, Inc., Robert F. Apple and Fred M. Powell Smith TM TM On January 12, 2018, a stockholder of the Company filed a derivative civil action, captioned Chiru Mackert, derivatively on behalf of Antares Pharma, Inc., v. Robert F. Apple, et al. Mackert Vikram Rao, Derivatively on Behalf of Antares Pharma, Inc. v. Robert F. Apple, et al. Rao On January 17, 2018, a stockholder of the Company filed a derivative civil action, captioned Robert Clark, Derivatively on Behalf of Antares Pharma, Inc. v. Robert F. Apple, et al. Clark Clark Patent Litigation Settlement Medac Pharma, Inc. (“Medac Pharma”) announced that it submitted a NDA to the FDA for an auto-pen containing methotrexate in the first quarter of 2014. On February 28, 2014, the Company filed a complaint against Medac Pharma and medac GmbH, the parent company of Medac Pharma, (medac GmbH, together with Medac Pharma, “Medac”) in the U.S. District Court for the District of Delaware, alleging infringement of two of the Company’s patents for technology regarding an auto injector and an auto injector containing methotrexate. On March 14, 2014, Antares filed a motion for preliminary injunction seeking to enjoin Medac from selling its methotrexate auto-pen product if and when such product is approved for sale in the United States, pending the final resolution of the litigation. On April 18, 2014 an amended complaint was filed asserting four Antares patents, and the motion for preliminary injunction was updated. On July 10, 2014, the District Court denied Antares’ motion for preliminary injunction. Antares filed an appeal of the denial of the motion for preliminary injunction with the U.S. Court of Appeals for the Federal Circuit, and in February 2015, that motion was denied. On March 7, 2014, Medac filed suit against Antares, LEO Pharma, Inc. and its parent company, LEO Pharma A/S (LEO Pharma, Inc. together with LEO Pharma A/S, the “LEO Entities”) in the U.S. District Court for the District of New Jersey, alleging that Antares and the LEO Entities infringe Medac Pharma’s U.S. Patent 8,664,231 (the “231 patent”) that was issued by the U.S. Patent and Trademark Office on March 4, 2014. Under the terms of the promotion and license agreement between the Company and the LEO Entities, the Company agreed to indemnify the LEO Entities from claims that OTREXUP ® In April 2015, Antares, Medac and the LEO Entities entered into a settlement agreement pursuant to which all of the proceedings related to Antares’ and Medac’s respective patents mentioned above and the proceeding pending before the Technical Board of Appeal of the European Patent Office were dismissed. The settlement agreement also provided for a royalty-free cross-license under the patents named in the proceedings and their families allowing the manufacture and sale of OTREXUP ® |
Quarterly Financial Data (unaud
Quarterly Financial Data (unaudited) | 12 Months Ended |
Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Data (unaudited) | 13. Quarterly Financial Data (unaudited) First Second Third Fourth 2017 Total revenues $ 12,007 $ 13,416 $ 15,052 $ 14,040 Gross profit 5,788 7,800 6,529 6,932 Net loss (4,736 ) (2,840 ) (5,453 ) (3,714 ) Net loss per common share (1) (0.03 ) (0.02 ) (0.03 ) (0.02 ) Weighted average shares 155,215,040 155,926,149 156,400,702 156,654,843 2016 Total revenues $ 12,319 $ 12,228 $ 13,479 $ 14,196 Gross profit 5,543 4,910 5,445 7,507 Net loss (7,656 ) (6,061 ) (6,121 ) (4,500 ) Net loss per common share (1) (0.05 ) (0.04 ) (0.04 ) (0.03 ) Weighted average shares 154,858,079 154,936,096 155,060,811 155,111,435 (1) Net loss per common share is computed based upon the weighted average number of shares outstanding during each period. Basic and diluted loss per share amounts are identical as the effect of potential common shares is anti-dilutive. |
Summary of Significant Accoun21
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements include the accounts of Antares Pharma, Inc. and its two wholly-owned foreign subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with U.S. generally accepted accounting principles 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 financial statements and the reported amounts of revenues and expenses during the reporting period. The Company’s significant accounting estimates relate to revenue recognition, inventory valuation, valuation of equity instruments used in stock-based compensation, and determination of the fair value and recoverability of long-lived assets including intangibles and goodwill. Actual results could differ from these estimates. |
Foreign Currency Translation | Foreign Currency Translation The majority of the foreign subsidiaries’ revenues are denominated in U.S. dollars, and any required funding of the subsidiaries is provided by the U.S. parent. Nearly all operating expenses of the foreign subsidiaries are denominated in Swiss Francs. Additionally, bank accounts held by foreign subsidiaries are denominated in Swiss Francs, there is a low volume of intercompany transactions and there is not an extensive interrelationship between the operations of the subsidiaries and the parent company. As such, the Company has determined that the Swiss Franc is the functional currency for its foreign subsidiaries. The reporting currency for the Company is the United States Dollar (“USD”). The financial statements of the Company’s foreign subsidiaries are translated into USD for consolidation purposes. All assets and liabilities are translated using period-end exchange rates and statements of operations items are translated using average exchange rates for the period. The resulting translation adjustments are recorded as a separate component of stockholders’ equity, comprising all of the accumulated other comprehensive income (loss). Sales to certain customers and purchases from certain vendors by the U.S. parent are in currencies other than the U.S. dollar and are subject to foreign currency exchange rate fluctuations. Foreign currency transaction gains and losses are included in foreign exchange gain (loss) in the consolidated statements of operations. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash consists of demand deposits at commercial banks. The Company also invests in cash equivalents consisting of highly liquid investments in money market funds with original maturities of three months or less. |
Investments | Investments The Company’s investments consist of U.S. Treasury bills and government agency notes that are classified as held-to-maturity because the Company has the intent and ability to hold the securities to maturity. Investments with maturities of one year or less are classified as short-term. The securities are carried at their amortized cost and the fair value is determined by quoted market prices. At December 31, 2017, the Company’s short-term investments had a carrying value of $4,993, which approximated fair value. The Company held no investments as of December 31, 2016. |
Accounts Receivable and Allowance for Doubtful Accounts | Accounts Receivable and Allowance for Doubtful Accounts Trade accounts receivable are stated at the amount the Company expects to collect. The Company considers the following factors when determining the collectability of specific customer accounts: customer credit-worthiness, past transaction history with the customer, current economic industry trends, and changes in customer payment terms. At December 31, 2017, the Company’s accounts receivable balance was due primarily from Teva, AMAG and distributors of OTREXUP ® |
Inventories | Inventories Inventories are stated at the lower of cost or net realizable value. Cost is determined on a first-in, first-out basis. Certain components of the Company’s products are provided by a limited number of vendors, and the Company’s production and assembly operations are outsourced to third-party suppliers where substantially all of the Company’s inventory is located. Disruption of supply from key vendors or third-party suppliers may have a material adverse impact on the Company’s operations. Inventory consists of the following: December 31, December 31, 2017 2016 Raw material $ 118 $ 143 Work in process 6,223 2,429 Finished goods 2,934 2,755 $ 9,275 $ 5,327 The Company provides reserves for potentially excess, dated or obsolete inventories based on estimates of forecasted product demand and the likelihood of consumption in the normal course of business, considering the expiration dates of the inventories on hand, planned production volumes and lead times required for restocking of customer inventories. Although every effort is made to ensure that forecasts and assessments are reasonable, changes to these assumptions are possible. In such cases, estimates may prove inaccurate and result in an understatement or overstatement of the reserves required to fairly state such inventories. The Company’s reserve for excess, dated or obsolete inventory was $510 and $900 at December 31, 2017 and 2016, respectively. In 2017, the Company wrote off inventory of $746 and increased the reserve for excess, dated or obsolete inventory by $356. In 2016, the Company wrote off $648 of inventory and increased the reserve for excess, dated or obsolete inventory by $748. |
Equipment, Molds, Furniture, and Fixtures | Equipment, Molds, Furniture, and Fixtures Equipment, molds, furniture, and fixtures are stated at cost and are depreciated using the straight-line method over their estimated useful lives ranging from three to ten years. The Company’s equipment, molds, furniture and fixtures consisted of the following: December 31, December 31, 2017 2016 Furniture, fixtures and office equipment $ 2,258 $ 2,234 Production molds and equipment 15,322 10,582 Molds and tooling in process 4,023 10,150 Less accumulated depreciation (5,445 ) (5,099 ) $ 16,158 $ 17,867 Depreciation expense was $1,536, $1,326 and $1,034 for the years ended December 31, 2017, 2016 and 2015, respectively. In 2017, the Company sold certain assets, including molds and equipment, to Ferring, the net book value of which was $933. |
Patent Rights | Patent Rights The Company capitalizes the costs of obtaining patent rights when there are projected future cash flows for marketed or partnered products associated with the patent. These capitalized costs are being amortized on a straight-line basis over the shorter of the life of the patent or the estimated useful life of the patent, which typically is over periods ranging from five to fifteen years beginning on the earlier of the date the patent is issued or the first commercial sale of product utilizing such patent rights. The Company periodically reviews capitalized patent costs to identify any amounts to be charged to expense for patents that are no longer being pursued or for which there are no future revenues or cash flows anticipated. The Company capitalizes external legal patent defense costs and costs for pursuing patent infringements when it determines that a successful outcome is probable and will lead to an increase in the value of the patent. The capitalized costs are amortized over the remaining life of the related patent. If changes in the anticipated outcome were to occur that reduce the likelihood of a successful outcome of the entire action to less than probable, the capitalized costs would be charged to expense in the period in which the change is determined. The gross carrying amount and accumulated amortization of patents was $3,772 and $2,371, respectively at December 31, 2017, and $4,659 and $2,614, respectively, at December 31, 2016. Patent amortization expense for the years ended December 31, 2017, 2016 and 2015 was $568, $534 and $536, respectively, and is recorded in selling, general and administrative expenses in the consolidated statements of operations. The Company’s estimated aggregate patent amortization expense for the next five years is $574, $327, $70, $57 and $47 in 2018, 2019, 2020, 2021 and 2022, respectively. In 2017, the Company sold certain assets, including patent rights, to Ferring. The net book value of the patents sold was $108. In 2017 and 2015, the Company expensed $46 and $31, respectively of capitalized patent costs for abandoned patents or patents no longer connected with current products. There was no write-off of patent costs in 2016. |
Impairment of Long-Lived Assets and Intangibles | Impairment of Long-Lived Assets and Intangibles Long-lived assets and intangibles, including patent rights, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset or asset group. This analysis can be very subjective; however, the Company utilizes the expected future undiscounted cash flows from signed license and distribution agreements and other contracts with customers to substantiate the recoverability of its long-lived assets. If the sum of the undiscounted cash flows is less than the carrying value of the asset, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the fair value of the assets. Assets to be disposed of are reported at the lower of the carrying amount or fair value less costs to sell. |
Goodwill | Goodwill Goodwill is evaluated for impairment annually at December 31, or more frequently if an event occurs or circumstances change that indicate that the carrying value may not be recoverable. In performing the annual impairment test, the Company compares the fair value of the reporting unit to the carrying amount and would recognize an impairment charge to goodwill for the amount by which the carrying amount exceeds the reporting unit’s fair value. At December 31, 2017 and 2016, the Company had goodwill with a carrying value of $1,095, attributable to its single reporting unit. Based on the results of its evaluations, the Company determined that goodwill was not impaired, and no impairment losses were recognized in the years ended December 31, 2017, 2016, and 2015, respectively. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying value of certain of the Company’s financial instruments, including accounts receivable and accounts payable, approximate fair value due to the short-term nature of the instruments. From time to time, the Company invests in U.S. Treasury bills or U.S. Treasury notes that are classified as held-to-maturity because the Company has the positive intent and ability to hold the securities to maturity. The investment securities are carried at amortized cost and fair value is determined by quoted market prices, which is a Level 1 fair value measurement. At December 31, 2017, the fair value of the Company’s short-term investments approximated the carrying values and no short-term investments were held at December 31, 2016. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue from the sale of products, development project milestones, license fees and royalties. Revenue is recognized when all of the following criteria are met: persuasive evidence of the arrangement exists; delivery has occurred and we have no remaining obligations; the fee is fixed or determinable; and collectability is reasonably assured. OTREXUP ® The Company began detailing OTREXUP ® ® Prior to the first quarter of 2017, the Company could not reliably estimate expected returns of OTREXUP ® ® In the first quarter of 2017, the Company determined it had developed sufficient historical information to reasonably estimate potential returns of OTREXUP ® Product sales revenue for OTREXUP ® Product Sales Allowances The Company recognizes product sales allowances as a reduction of product sales in the same period the related revenue is recognized. Product sales allowances are based on amounts owed or to be claimed on the related sales. These estimates take into consideration the terms of our agreements with customers and third-party payers and the levels of inventory within the distribution channels that may result in future rebates or discounts taken. In certain cases, such as patient support programs, the Company recognizes the cost of patient discounts as a reduction of revenue based on estimated utilization. If actual future results vary, it may be necessary to adjust these estimates, which could have an effect on product revenue in the period of adjustment. Product sales allowances include: Wholesaler Distribution Fees . Distribution fees are paid to certain wholesale distributors based on contractually determined rates. The Company accrues the fee on shipment to the respective wholesale distributors and recognizes the fee as a reduction of revenue in the same period the related revenue is recognized. Prompt Pay Discounts . The Company offers cash discounts to its customers, generally 2% of the sales price, as an incentive for prompt payment. The Company accounts for cash discounts by reducing accounts receivable by the prompt pay discount amount and recognizes the discount as a reduction of revenue in the same period the related revenue is recognized. Chargebacks . The Company provides discounts primarily to authorized users of the Federal Supply Schedule (“FSS”) of the General Services Administration under an FSS contract negotiated by the Department of Veterans Affairs and various organizations under Medicaid contracts and regulations. These entities purchase products from the wholesale distributors at a discounted price, and the wholesale distributors then charge back to the Company the difference between the current wholesale acquisition cost and the price the entity paid for the product. The Company will estimate and accrue chargebacks based on estimated wholesaler inventory levels, current contract prices and historical chargeback activity. Chargebacks are recognized as a reduction of revenue in the same period the related revenue is recognized. Rebates . The Company participates in certain rebate programs, which provide discounted prescriptions to qualified insured patients. Under these rebate programs, the Company will pay a rebate to the third-party administrator of the program, generally two to three months after the quarter in which prescriptions subject to the rebate are filled. The Company estimates and accrues for these rebates based on current contract prices, historical and estimated future percentages of product sold to qualified patients. Rebates are recognized as a reduction of revenue in the same period the related revenue is recognized. Patient Discount Programs. The Company offers discount card programs to patients for OTREXUP ® Sumatriptan Revenue Recognition Under a license, supply and distribution agreement with Teva for an auto-injector product containing sumatriptan, the Company produces devices and assembles final product for shipment to Teva, and Teva is responsible for commercial distribution and sale of the product. The Company is compensated, and recognizes revenue, at cost for shipments of product delivered to Teva. The Company is also entitled to receive 50 percent of the net profits from commercial sales made by Teva, payable to the Company within 45 days after the end of the quarter in which the commercial sales are made. Sumatriptan Injection USP was launched for commercial sale in June 2016. Initially, given the limited access to sales data and the 45-day lag in reporting of the profit split from Teva, management was not able to estimate the profit margin the Company expected to receive from commercial sales made by Teva at the time of sale. Accordingly, prior to the third quarter of 2017, revenue from the profit sharing arrangement was recognized in the period following the commercial sales by Teva when amounts were reported and paid to the Company. Beginning in the third quarter of 2017, management determined it had developed sufficient history and is now able to obtain additional sales information in order to reasonably estimate and recognize revenue from the profit sharing arrangement when product is sold by Teva. The change in estimation and recognition had no material impact on the Company’s consolidated financial statements. Other Revenue Recognition The Company sells reusable needle-free injectors and related disposable products to pharmaceutical partners. The reusable injectors and related disposable products are not interchangeable with any competitive products and must be used together. The Company recognizes revenue upon shipment when title transfers. The Company offers no price protection or return rights other than for customary warranty claims. Sales terms and pricing are governed by license and distribution agreements. Revenue arrangements with multiple deliverables are divided into separate units of accounting if certain criteria are met, including whether the deliverable has stand-alone value to the customer, the customer has a general right of return relative to the delivered item and delivery or performance of the undelivered item is probable and substantially within the vendor’s control. Arrangement consideration is allocated at the inception of the arrangement to all deliverables on the basis of their relative selling price. The selling price for each deliverable is determined using: (i) vendor-specific objective evidence of selling price (“VSOE”), if it exists, (ii) third-party evidence of selling price (“TPE”) if VSOE does not exist, and (iii) the Company’s best estimate of the selling price if neither VSOE nor TPE exists. Revenue, excluding variable consideration, is recognized upon completion of deliverables based on the relative selling price of each deliverable that was assigned at inception of the arrangement. Royalty revenue is recognized in the period in which it is earned when the Company has sufficient information to determine its quarterly royalty earnings to be received from partners. |
Share-Based Compensation | Share-Based Compensation The Company utilizes share based compensation in the form of stock options, restricted stock units (“RSUs”) and performance-based restricted stock units (“PSUs”). The Company records compensation expense associated with share based awards granted to employees at the fair value of the award on the date of grant. The Company uses the Black-Scholes option valuation model to determine the fair value of stock options. The fair values of RSU and PSU grants containing service or performance conditions are based on the market value of the Company’s Common Stock on the date of grant. The fair value of PSUs containing a market condition are estimated using a Monte Carlo simulation. The value of the portion of the award that is ultimately expected to vest is expensed ratably over the requisite service period as compensation expense in the consolidated statement of operations. Forfeitures are recorded as incurred. Assumptions concerning the Company’s stock price volatility and projected employee exercise behavior over the contractual life of the award can significantly impact the estimated fair value of an award. |
Product Warranty | Product Warranty The Company provides a warranty on its reusable needle-free injector devices. The warranty period on a needle-free injector device is typically 24 months from either the date of retail sale of the device by a dealer or distributor or the date of shipment to a customer if specified by contract. The Company recognizes the estimated cost of warranty obligations at the time the products are shipped based on historical claims incurred by the Company. Actual warranty claim costs could differ from these estimates. The Company had $50 and $100 in warranty liability reserves as of December 31, 2017 and 2016, respectively. |
Research and Development | Research and Development Research and development expenses include costs directly attributable to the conduct of research and development programs including personnel costs, materials and supplies associated with design work and prototype development, FDA fees and the cost of services provided by outside contractors such as expenses related to clinical trials. All costs associated with research and development activities are expensed as incurred. |
Income Taxes | Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized. On December 22, 2017, the President of the United States signed into law the Tax Cuts and Jobs Act (“TCJA”). This legislation makes broad and complex changes to the U.S. tax code. The U.S. Securities and Exchange Commission (“SEC”) staff issued guidance on accounting for the tax effects of TCJA under Staff Accounting Bulletin No. 118 (“SAB 118”). SAB 118 provides a one-year measurement period for companies to complete its accounting for the tax effects of TCJA. The Company calculated its best estimate of the impact of the TCJA based on its understanding of the TCJA and guidance available as of the filing date and recorded provisional amounts as of December 31, 2017. U.S. Treasury regulations, administrative interpretations or court decisions interpreting the TCJA may require changes in these estimates. The final determination of the effects of the TCJA will be completed as additional information becomes available, but no later than one year from the enactment of the TCJA. Any subsequent adjustment to the estimated amounts is not expected to be material to the financial statements. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is computed by dividing net income or loss available to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed similar to basic net loss per share except that the weighted average shares outstanding are increased to include additional shares from the assumed exercise of stock options and warrants, if dilutive. The number of additional shares is calculated by assuming that outstanding stock options or warrants were exercised and that the proceeds from such exercise were used to acquire shares of common stock at the average market price during the reporting period. All potentially dilutive common shares were excluded from the calculation because they were anti-dilutive for all periods presented. Potentially dilutive securities excluded from dilutive loss per share were 14,761,442, 13,483,856 and 11,151,503 at December 31, 2017, 2016 and 2015, respectively. |
Segment Information | Segment Information Operating segments are components of an enterprise for which separate financial information is available and is evaluated regularly by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company’s chief operating decision maker currently evaluates the Company’s operations as a whole from a number of different operational perspectives, including but not limited to, on a product-by-product, customer and partner basis. The Company derives all significant revenues from self-administered parenteral pharmaceutical products and technologies, and has a single reportable operating segment of business. Accordingly, the Company does not report more than one segment; nevertheless, management periodically evaluates whether the Company continues to have one single reportable segment of business. |
Going Concern | Going Concern Management is responsible for evaluating, and providing disclosure of uncertainties about, the Company’s ability to continue as a going concern. As of December 31, 2017, the Company had cash, cash equivalents and short-term investments of $31,555. Based on management’s evaluation, management concluded there is no substantial doubt or uncertainty about the Company’s ability to meet its obligations within one year from the date the financial statements were issued. |
Recent Accounting Pronouncements | Accounting Pronouncements Recently Adopted In July 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2015-11, Simplifying the Measurement of Inventory In March 2016, the FASB issued ASU No. 2016-09, Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting “ In January 2017, the FASB issued ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business (“ASU 2017-01”), which provides additional clarification to aid in determining when a set of assets and activities is not a business, and In January 2017, the FASB issued ASU 2017-04, Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment Recent Accounting Pronouncements Not Yet Adopted In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers The Company has reviewed all of its major contracts with customers and has adopted the new revenue recognition standard effective January 1, 2018 utilizing the modified retrospective method of adoption. The adoption of ASU No. 2014-09 did not have a material impact on the Company’s consolidated financial statements. No significant changes to business processes or systems have been necessary. In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) In May 2017, the FASB issued ASU No. 2017-09, Compensation – Stock Compensation (Topic 718): Scope of Modification Accounting In May 2017, the FASB issued ASU No. 2017-05, Other Income – Gains and Losses from the Derecognition of Nonfinancial Assets (Subtopic 610-20): Clarifying the Scope of Asset Derecognition Guidance and Accounting for Partial Sales of Nonfinancial Assets |
Summary of Significant Accoun22
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Inventories | Inventory consists of the following: December 31, December 31, 2017 2016 Raw material $ 118 $ 143 Work in process 6,223 2,429 Finished goods 2,934 2,755 $ 9,275 $ 5,327 |
Components of Equipment, Molds, Furniture, and Fixtures | The Company’s equipment, molds, furniture and fixtures consisted of the following: December 31, December 31, 2017 2016 Furniture, fixtures and office equipment $ 2,258 $ 2,234 Production molds and equipment 15,322 10,582 Molds and tooling in process 4,023 10,150 Less accumulated depreciation (5,445 ) (5,099 ) $ 16,158 $ 17,867 |
Sales of Assets (Tables)
Sales of Assets (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Sale Of Assets [Abstract] | |
Schedule of Gain on Sale of Assets | For the year ended December 31, 2017, the Company recorded a gain on sale of assets upon receipt of the non-refundable upfront payment from Ferring and transfer of certain manufacturing equipment and patents as follows: Proceeds from sale of assets $ 2,000 Less: Net book value of molds and equipment transferred 933 Net book value of patents transferred 108 Payment of transaction costs 99 Gain on sale of assets $ 860 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Debt Disclosure [Abstract] | |
Schedule of Future Principal Payments under Term Loan, Including End of Term Charge | Future principal payments under the term loan, including the End of Term Charge, are as follows: 2018 $ — 2019 3,065 2020 7,857 2021 8,610 2022 6,531 $ 26,063 |
Share Based Compensation (Table
Share Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Summary of Stock Option Activity | Stock option activity under the Plan as of and for the three years ended December 31, 2017 is as follows: Weighted Weighted Average Average Remaining Aggregate Number of Exercise Contractual Intrinsic Shares Price ($) Term (Years) Value ($) Outstanding at December 31, 2014 7,245,485 2.25 Granted/Issued 2,984,010 2.23 Exercised (20,000 ) 1.54 — Cancelled/Forfeited (728,998 ) 2.92 Outstanding at December 31, 2015 9,480,497 2.19 Granted/Issued 4,029,500 1.14 Exercised (142,493 ) 1.23 122 Cancelled/Forfeited (2,053,595 ) 2.13 Outstanding at December 31, 2016 11,313,909 1.84 Granted/Issued 2,985,667 2.67 Exercised (1,311,293 ) 1.38 2,226 Cancelled/Forfeited (839,455 ) 2.68 Outstanding at December 31, 2017 12,148,828 2.04 7.1 4,206 Exercisable at December 31, 2017 8,443,947 1.99 6.3 3,201 |
Assumptions Used in Fair Value Measurement of Options Granted | December 31, 2017 2016 2015 Risk-free interest rate 1.8 % 1.3 % 1.3 % Annualized volatility 53.3 % 51.7 % 53.5 % Weighted average expected life, in years 6.0 6.0 6.0 Expected dividend yield 0.0 % 0.0 % 0.0 % |
Schedule of Performance Stock Unit Awards and Restricted Stock Granted Under Long Term Incentive Program | The performance stock unit awards and restricted stock unit awards granted under the long term incentive program are summarized in the following table: Performance Stock Units Restricted Stock Units Number of Shares Weighted Average Date Fair Value ($) Number of Shares Weighted Average Grant Date Fair Value ($) Outstanding at December 31, 2014 463,542 3.08 231,124 3.07 Granted 664,391 2.09 664,391 2.18 Vested/settled — (112,285 ) 2.92 Forfeited/expired (171,755 ) 2.69 (68,402 ) 2.47 Outstanding at December 31, 2015 956,178 2.40 714,828 2.32 Granted 750,500 1.15 750,500 1.12 Vested/settled (16,835 ) 3.96 (264,001 ) 2.41 Forfeited/expired (342,554 ) 2.17 (378,669 ) 1.91 Outstanding at December 31, 2016 1,347,289 1.50 822,658 1.39 Granted 689,180 3.12 689,180 2.69 Vested/settled — (287,508 ) 1.49 Forfeited/expired (580,721 ) 2.16 (67,464 ) 1.70 Outstanding at December 31, 2017 1,455,748 2.20 1,156,866 2.12 |
Performance Stock Units [Member] | |
Assumptions Used in Fair Value Measurement of Options Granted | The fair values of the TSR PSUs granted were determined using a Monte Carlo simulation and utilized the following inputs and assumptions: 2017 Award 2016 Award 2015 Award Closing stock price on grant date $ 2.66 $ 1.12 $ 2.18 Performance period starting price $ 2.17 $ 1.29 $ 2.52 Term of award (in years) 2.57 2.58 2.59 Volatility 54.6 % 70.1 % 60.5 % Risk-free interest rate 1.39 % 0.97 % 0.83 % Expected dividend yield 0.00 % 0.00 % 0.00 % Fair value per TSR PSU $ 3.10 $ 1.25 $ 1.71 |
Accrued Expenses and Other Li26
Accrued Expenses and Other Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consisted of the following: December 31, December 31, 2017 2016 Accrued expenses and other liabilities: Accrued employee compensation and benefits $ 2,470 $ 2,703 OTREXUP ® 2,140 1,484 Other liabilities 2,372 1,686 $ 6,982 $ 5,873 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Leases [Abstract] | |
Summary of Future Minimum Lease Payments | Future minimum lease payments under operating leases with remaining terms in excess of one year as of December 31, 2017 were as follows: Amount 2018 $ 623 2019 566 2020 233 2021 238 2022 60 Thereafter — Total future minimum lease payments $ 1,720 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income (Loss) before Income Tax Domestic and Foreign | Income (loss) before income taxes was derived from the following jurisdictions: 2017 2016 2015 U.S. $ (16,762 ) $ (24,229 ) $ (21,831 ) Switzerland 19 (10 ) 1,347 $ (16,743 ) $ (24,239 ) $ (20,484 ) |
Summary of Effective Tax Rates Differ from Statutory Income Tax Rates | Effective tax rates differ from statutory income tax rates in the years ended December 31, 2017, 2016 and 2015 as follows: 2017 2016 2015 Statutory income tax rate (34.0 )% (34.0 )% (34.0 )% State income taxes (6.1 ) (6.8 ) (5.7 ) Valuation allowance increase (102.0 ) 35.9 35.2 Effect of foreign operations — — (1.3 ) Change in unused net operating loss and credit carryforwards (4.0 ) 3.7 2.8 Nondeductible items 1.6 1.6 3.9 Impact of Tax Cuts and Jobs Act 144.5 — — 0.0 % 0.4 % 0.9 % |
Summary of Deferred Tax Assets (Liabilities) | Deferred tax assets (liabilities) as of December 31, 2017 and 2016 consist of the following: 2017 2016 Gross deferred tax assets: Net operating loss carryforward – U.S. $ 43,046 $ 58,206 Net operating loss carryforward – Switzerland 67 65 Research and development tax credit carryforward 6,153 5,477 Deferred revenue 339 438 Stock-based compensation 1,882 2,678 Inventory reserve 140 364 Compensation accruals 662 996 Other 575 378 52,864 68,602 Gross deferred tax liabilities – depreciation and amortization (826 ) (844 ) Less valuation allowance (52,038 ) (67,758 ) Net deferred tax asset $ — $ — |
Significant Customers and Con29
Significant Customers and Concentrations of Risk (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Risks And Uncertainties [Abstract] | |
Summary of Revenues by Customer Location | Revenues by customer geographic location are summarized as follows: For the Years Ended December 31, 2017 2016 2015 United States of America $ 48,924 $ 45,531 $ 39,229 Europe 5,061 6,117 6,026 Other 530 574 403 $ 54,515 $ 52,222 $ 45,658 |
Summary of Significant Customers from which the Company Derived 10% or More of Total Revenue | Significant customers from which the Company derived 10% or more of its total revenue in any of the periods presented are as follows: For the Years Ended December 31, 2017 2016 2015 Teva $ 20,949 $ 24,941 $ 17,715 AMAG 8,965 4,446 365 McKesson (1) 8,707 7,600 6,837 AmerisourceBergen (1) 6,098 4,903 4,527 Ferring 5,258 6,283 6,117 LEO Pharma — — 6,000 (1) Revenue net of estimated sales returns and allowances based on OTREXUP ® |
Quarterly Financial Data (una30
Quarterly Financial Data (unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Data | First Second Third Fourth 2017 Total revenues $ 12,007 $ 13,416 $ 15,052 $ 14,040 Gross profit 5,788 7,800 6,529 6,932 Net loss (4,736 ) (2,840 ) (5,453 ) (3,714 ) Net loss per common share (1) (0.03 ) (0.02 ) (0.03 ) (0.02 ) Weighted average shares 155,215,040 155,926,149 156,400,702 156,654,843 2016 Total revenues $ 12,319 $ 12,228 $ 13,479 $ 14,196 Gross profit 5,543 4,910 5,445 7,507 Net loss (7,656 ) (6,061 ) (6,121 ) (4,500 ) Net loss per common share (1) (0.05 ) (0.04 ) (0.04 ) (0.03 ) Weighted average shares 154,858,079 154,936,096 155,060,811 155,111,435 (1) Net loss per common share is computed based upon the weighted average number of shares outstanding during each period. Basic and diluted loss per share amounts are identical as the effect of potential common shares is anti-dilutive. |
Summary of Significant Accoun31
Summary of Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2017USD ($) | Dec. 31, 2017USD ($)Subsidiary$ / sharesshares | Dec. 31, 2016USD ($)shares | Dec. 31, 2015USD ($)shares | |
Summary Of Significant Accounting Policies [Line Items] | ||||
Wholly-owned subsidiaries of Antares Pharma | Subsidiary | 2 | |||
Carrying value of short-term investments | $ 4,993,000 | $ 0 | ||
Bad debt expense | 0 | 0 | $ 0 | |
Allowance for doubtful accounts balance | 0 | 0 | ||
Inventory reserve | 510,000 | 900,000 | ||
Inventory written-off | 746,000 | 648,000 | ||
Increase in inventory reserve | 356,000 | 748,000 | 700,000 | |
Depreciation expense | 1,536,000 | 1,326,000 | 1,034,000 | |
Patent rights | 3,772,000 | 4,659,000 | ||
Accumulated amortization of patents | 2,371,000 | 2,614,000 | ||
Aggregate patent amortization expense, 2018 | 574,000 | |||
Aggregate patent amortization expense, 2019 | 327,000 | |||
Aggregate patent amortization expense, 2020 | 70,000 | |||
Aggregate patent amortization expense, 2021 | 57,000 | |||
Aggregate patent amortization expense, 2022 | 47,000 | |||
Amortization expense | 568,000 | 534,000 | 536,000 | |
Net book value of patents sold | 108,000 | |||
Patent write off | 46,000 | 0 | 31,000 | |
Goodwill | 1,095,000 | 1,095,000 | ||
Goodwill impairment loss | $ 0 | 0 | $ 0 | |
Cash discount to incentive for prompt payment | 2.00% | |||
Method used for fair value assumption | Black-Scholes option valuation model | |||
Warranty period of device | 24 months | |||
Warranty liability reserves | $ 50,000 | $ 100,000 | ||
Potentially dilutive securities excluded from dilutive loss per share | shares | 14,761,442 | 13,483,856 | 11,151,503 | |
Cash, cash equivalents and short-term investments | $ 31,555,000 | |||
ASU 2016-09 [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Cumulative effect adjustment to accumulated deficit and additional paid-in capital | $ 97,000 | |||
Teva [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Future net profits from commercial sales percent | 50.00% | |||
OTREXUP [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Additional revenue recognized, not previously recognized | $ 1,297,000 | |||
Related product costs recognized | $ 254,000 | |||
Revenue Recognition, reduction in net loss | $ 1,043,000 | |||
Minimum [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Estimated useful lives | 3 years | |||
Capitalized cost being amortized over periods | 5 years | |||
Maximum [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Estimated useful lives | 10 years | |||
Capitalized cost being amortized over periods | 15 years | |||
Maximum [Member] | OTREXUP [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Revenue Recognition, reduction in net loss per share | $ / shares | $ 0.01 |
Summary of Significant Accoun32
Summary of Significant Accounting Policies - Inventories (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Inventory Disclosure [Abstract] | ||
Raw material | $ 118 | $ 143 |
Work in process | 6,223 | 2,429 |
Finished goods | 2,934 | 2,755 |
Inventory, Total | $ 9,275 | $ 5,327 |
Summary of Significant Accoun33
Summary of Significant Accounting Policies - Components of Equipment, Molds, Furniture, and Fixtures (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Property Plant And Equipment [Abstract] | ||
Furniture, fixtures and office equipment | $ 2,258 | $ 2,234 |
Production molds and equipment | 15,322 | 10,582 |
Molds and tooling in process | 4,023 | 10,150 |
Less accumulated depreciation | 5,445 | 5,099 |
Equipment, molds, furniture and fixtures, Total | $ 16,158 | $ 17,867 |
Sale of Assets - Additional Inf
Sale of Assets - Additional Information (Detail) - Asset Purchase Agreement [Member] - Ferring [Member] - ZOMAJET [Member] $ in Thousands | 1 Months Ended | |
Oct. 31, 2017USD ($)Installment | Feb. 28, 2018USD ($) | |
Sale Of Assets [Line Items] | ||
Total purchase price | $ 14,500 | |
Number of installments paid for purchase price | Installment | 4 | |
Description of purchase price payment | The purchase price is to be paid in four installments consisting of the following: a $2.0 million upfront payment, which was received upon entry into the Asset Purchase Agreement and the transfer of certain assets; a second installment of $2.75 million received upon delivery of certain documentation and satisfaction of certain conditions primarily related to product manufacturing, which occurred in February 2018; a third installment of $4.75 million payable upon satisfaction of certain conditions, including further document transfer, the successful completion of a regulatory audit by a notified body, and a pilot manufacturing run under Ferring’s supervision; and a final installment of $5.0 million upon Ferring’s receipt of the CE Mark needed to continue to commercialize the product in certain territories and the final transfer of certain product-related inventory, equipment and agreements to Ferring (the “Completion Date”), which is expected to occur by the end of 2018. | |
Upfront payment received upon transfer of assets | $ 2,000 | |
Consideration receivable on criteria completion related to Audit and pilot manufacturing | 4,750 | |
Consideration receivable on criteria completion related to Product commercialization | $ 5,000 | |
Subsequent Event [Member] | ||
Sale Of Assets [Line Items] | ||
Consideration receivable on criteria completion related to product manufacturing | $ 2,750 |
Sale of Assets - Schedule of Ga
Sale of Assets - Schedule of Gain on Sale of Assets (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2017USD ($) | |
Sale Of Assets [Line Items] | |
Net book value of patents transferred | $ 108 |
Gain on sale of assets | 860 |
Asset Purchase Agreement [Member] | Ferring [Member] | ZOMAJET [Member] | |
Sale Of Assets [Line Items] | |
Proceeds from sale of assets | 2,000 |
Net book value of molds and equipment transferred | 933 |
Net book value of patents transferred | 108 |
Payment of transaction costs | 99 |
Gain on sale of assets | $ 860 |
Long-Term Debt - Additional Inf
Long-Term Debt - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended |
Jun. 30, 2017 | Dec. 31, 2017 | |
Debt Instrument [Line Items] | ||
Advance of funded upon execution of loan agreement | $ 25,000,000 | |
Carrying value of long term debt | $ 24,858,000 | |
Hercules Capital, Inc [Member] | Term Loan [Member] | ||
Debt Instrument [Line Items] | ||
Long-tem debt, face amount | $ 35,000,000 | |
Advance of funded upon execution of loan agreement | 25,000,000 | |
Debt Instrument, covenant description | Under the terms of the Loan Agreement, the Company may, but is not obligated to, request one or more additional advances of at least $5.0 million not to exceed $10.0 million in the aggregate, subject to the Company achieving certain corporate milestones and satisfying customary conditions. | |
Debt instrument, maturity date Description | The Term Loan is secured by substantially all of the Company’s assets, excluding intellectual property, and will mature on July 1, 2022. | |
Debt instrument, maturity date | Jul. 1, 2022 | |
Debt Instrument, interest rate | 8.75% | |
Debt instrument, payment terms | Payments under the Loan Agreement are interest only until the first principal payment is due on August 1, 2019, provided that the interest only period may be extended to February 1, 2020 if the Company achieves certain corporate milestones. | |
Debt instrument, first pricipal payment due date | Aug. 1, 2019 | |
Debt instrument, first pricipal payment may be extended date | Feb. 1, 2020 | |
Percentage of loan fee on original principal amount | 4.25% | |
Carrying value of long term debt | $ 24,858,000 | |
Principal balance outstanding | 25,000,000 | |
Term charge accrual | 119,000 | |
Unamortized debt issuance costs | 261,000 | |
Interest paid | $ 1,080,000 | |
Hercules Capital, Inc [Member] | Term Loan [Member] | Prime Based Variable Rate [Member] | ||
Debt Instrument [Line Items] | ||
Debt Instrument, variable interest rate | 9.50% | |
Hercules Capital, Inc [Member] | Term Loan [Member] | Minimum [Member] | ||
Debt Instrument [Line Items] | ||
Prepayment fee percentage on principal loan prepaid | 1.00% | |
Hercules Capital, Inc [Member] | Term Loan [Member] | Maximum [Member] | ||
Debt Instrument [Line Items] | ||
Prepayment fee percentage on principal loan prepaid | 3.00% | |
Hercules Capital, Inc [Member] | Term Loan [Member] | Minimum [Member] | ||
Debt Instrument [Line Items] | ||
Amount of additional advances Company may request | 5,000,000 | |
Hercules Capital, Inc [Member] | Term Loan [Member] | Maximum [Member] | ||
Debt Instrument [Line Items] | ||
Amount of additional advances Company may request | $ 10,000,000 |
Long-Term Debt - Schedule of Fu
Long-Term Debt - Schedule of Future Principal Payments under Term Loan, Including End of Term Charge (Detail) $ in Thousands | Dec. 31, 2017USD ($) |
Debt Disclosure [Abstract] | |
2,019 | $ 3,065 |
2,020 | 7,857 |
2,021 | 8,610 |
2,022 | 6,531 |
Long-term debt | $ 26,063 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) | May 11, 2015 | Aug. 31, 2017 | Dec. 31, 2015 |
Stockholders Equity [Line Items] | |||
Aggregate offering price of common stock | $ 42,850,000 | ||
Proceeds from sale of common stock | $ 42,851,000 | ||
Underwritten Public Offering [Member] | |||
Stockholders Equity [Line Items] | |||
Proceeds from sale of common stock | $ 42,900,000 | ||
Issuance of common stock, shares | 23,000,000 | ||
Common stock price per shares | $ 2 | ||
Sales Agreement [Member] | Cowen and Company, LLC [Member] | |||
Stockholders Equity [Line Items] | |||
Percentage of commission on proceeds from gross sales of common stock | 3.00% | ||
Proceeds from sale of common stock | $ 0 | ||
Sales Agreement [Member] | Cowen and Company, LLC [Member] | Maximum [Member] | |||
Stockholders Equity [Line Items] | |||
Aggregate offering price of common stock | $ 30,000,000 |
Share Based Compensation - Addi
Share Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Jun. 30, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Proceeds from the issuance of stock options | $ 1,816 | $ 101 | $ 31 | |
Shares withheld to meet employees' minimum statutory income tax obligation | 97,586 | 73,888 | 39,665 | |
Payments for the employees' minimum statutory income tax obligation | $ 249 | $ 84 | $ 88 | |
Amended and Restated 2008 Equity Compensation Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Share-based compensation arrangement by share-based payment award, number of shares authorized | 32,200,000 | |||
Maximum number of shares of stock granted to one participant | 4,000,000 | |||
Minimum percentage of exercise price | 100.00% | |||
Shares available for grant under the plan | 6,500,000 | |||
Minimum [Member] | Amended and Restated 2008 Equity Compensation Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 1 year | |||
Stock Options [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized compensation cost related to nonvested outstanding stock awards | $ 3,793 | |||
Weighted average period expected to be recognized | 1 year 10 months 24 days | |||
Recognized compensation cost related to shares of stock granted | $ 2,378 | $ 2,039 | $ 2,883 | |
Per share weighted average fair value of options granted | $ 1.37 | $ 0.57 | $ 1.13 | |
Proceeds from the issuance of stock options | $ 1,816 | $ 101 | $ 31 | |
Exercise of options, shares | 1,311,293 | 102,776 | 20,000 | |
Shares withheld to meet employees' minimum statutory income tax obligation | 39,717 | |||
Stock Options [Member] | Long Term Incentive Program [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 3 years | |||
Contractual term of options granted | 10 years | |||
Stock Options [Member] | Amended and Restated 2008 Equity Compensation Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 3 years | |||
Contractual term of options granted | 10 years | |||
Restricted Stock Units [Member] | Long Term Incentive Program [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 3 years | |||
Recognized compensation cost related to shares of stock granted | $ 701 | $ 413 | $ 526 | |
Performance Stock Units [Member] | Long Term Incentive Program [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Recognized compensation cost related to shares of stock granted | $ 411 | $ 68 | $ 250 | |
Performance Stock Units [Member] | Minimum [Member] | Long Term Incentive Program [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 3 years | |||
Share based compensation award percentage | 0.00% | |||
Performance Stock Units [Member] | Maximum [Member] | Long Term Incentive Program [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 5 years | |||
Share based compensation award percentage | 150.00% |
Share Based Compensation - Stoc
Share Based Compensation - Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Stockholders Equity Note [Abstract] | |||
Number of Shares Outstanding, Beginning Balance | 11,313,909 | 9,480,497 | 7,245,485 |
Number of Shares Granted/Issued | 2,985,667 | 4,029,500 | 2,984,010 |
Number of Shares Exercised | (1,311,293) | (142,493) | (20,000) |
Number of Shares Cancelled/Forfeited | (839,455) | (2,053,595) | (728,998) |
Number of Shares Outstanding, Ending Balance | 12,148,828 | 11,313,909 | 9,480,497 |
Number of Shares Exercisable, Ending Balance | 8,443,947 | ||
Weighted Average Exercise Price Outstanding, Beginning Balance | $ 1.84 | $ 2.19 | $ 2.25 |
Weighted Average Exercise Price Granted/Issued | 2.67 | 1.14 | 2.23 |
Weighted Average Exercise Price Exercised | 1.38 | 1.23 | 1.54 |
Weighted Average Exercise Price Cancelled/Forfeited | 2.68 | 2.13 | 2.92 |
Weighted Average Exercise Price Outstanding, Ending Balance | 2.04 | $ 1.84 | $ 2.19 |
Weighted Average Exercise Price Exercisable, Ending Balance | $ 1.99 | ||
Weighted Average Remaining Contractual Term (Years) Outstanding, Ending Balance | 7 years 1 month 6 days | ||
Weighted Average Remaining Contractual Term (Years) Exercisable, Ending Balance | 6 years 3 months 18 days | ||
Aggregate Intrinsic Value, Exercised | $ 2,226 | $ 122 | |
Aggregate Intrinsic Value Outstanding, Ending Balance | 4,206 | ||
Aggregate Intrinsic Value Exercisable, Ending Balance | $ 3,201 |
Share Based Compensation - Assu
Share Based Compensation - Assumptions Used in Fair Value Measurement of Options Granted (Detail) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Stockholders Equity Note [Abstract] | |||
Risk-free interest rate | 1.80% | 1.30% | 1.30% |
Annualized volatility | 53.30% | 51.70% | 53.50% |
Weighted average expected life, in years | 6 years | 6 years | 6 years |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Share Based Compensation - Sche
Share Based Compensation - Schedule of Performance Stock Unit Awards and Restricted Stock Granted Under Long Term Incentive Program (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Performance Stock Units [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of Shares, Beginning Balance | 1,347,289 | 956,178 | 463,542 |
Number of Shares, Granted | 689,180 | 750,500 | 664,391 |
Number of Shares, Vested/settled | (16,835) | ||
Number of Shares, Forfeited/expired | (580,721) | (342,554) | (171,755) |
Number of Shares, Ending Balance | 1,455,748 | 1,347,289 | 956,178 |
Weighted Average Grant Date Fair Value, Beginning Balance | $ 1.50 | $ 2.40 | $ 3.08 |
Weighted Average Grant Date Fair Value, Granted | 3.12 | 1.15 | 2.09 |
Weighted Average Grant Date Fair Value, Vested/settled | 3.96 | ||
Weighted Average Grant Date Fair Value, Forfeited/expired | 2.16 | 2.17 | 2.69 |
Weighted Average Grant Date Fair Value, Ending Balance | $ 2.20 | $ 1.50 | $ 2.40 |
Restricted Stock Units [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of Shares, Beginning Balance | 822,658 | 714,828 | 231,124 |
Number of Shares, Granted | 689,180 | 750,500 | 664,391 |
Number of Shares, Vested/settled | (287,508) | (264,001) | (112,285) |
Number of Shares, Forfeited/expired | (67,464) | (378,669) | (68,402) |
Number of Shares, Ending Balance | 1,156,866 | 822,658 | 714,828 |
Weighted Average Grant Date Fair Value, Beginning Balance | $ 1.39 | $ 2.32 | $ 3.07 |
Weighted Average Grant Date Fair Value, Granted | 2.69 | 1.12 | 2.18 |
Weighted Average Grant Date Fair Value, Vested/settled | 1.49 | 2.41 | 2.92 |
Weighted Average Grant Date Fair Value, Forfeited/expired | 1.70 | 1.91 | 2.47 |
Weighted Average Grant Date Fair Value, Ending Balance | $ 2.12 | $ 1.39 | $ 2.32 |
Share Based Compensation - Fair
Share Based Compensation - Fair Value of PSUs Granted Determined Using Monte Carlo Simulation (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Term of award (in years) | 6 years | 6 years | 6 years |
Volatility | 53.30% | 51.70% | 53.50% |
Risk-free interest rate | 1.80% | 1.30% | 1.30% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Performance Stock Units [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Closing stock price on grant date | $ 2.66 | $ 1.12 | $ 2.18 |
Performance period starting price | $ 2.17 | $ 1.29 | $ 2.52 |
Term of award (in years) | 2 years 6 months 25 days | 2 years 6 months 29 days | 2 years 7 months 2 days |
Volatility | 54.60% | 70.10% | 60.50% |
Risk-free interest rate | 1.39% | 0.97% | 0.83% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Fair value per TSR PSU | $ 3.10 | $ 1.25 | $ 1.71 |
Accrued Expenses and Other Li44
Accrued Expenses and Other Liabilities - Schedule of Accrued Expenses and Other Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2017 | Dec. 31, 2016 |
Accrued expenses and other liabilities: | ||
Accrued employee compensation and benefits | $ 2,470 | $ 2,703 |
Other liabilities | 2,372 | 1,686 |
Accrued expenses and other liabilities | 6,982 | 5,873 |
OTREXUP [Member] | ||
Accrued expenses and other liabilities: | ||
OTREXUP® product returns and sales allowances | $ 2,140 | $ 1,484 |
Employee 401(k) Savings Plan -
Employee 401(k) Savings Plan - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Postemployment Benefits [Abstract] | |||
Defined Contribution Plan, Plan Name | 401(k) | ||
Maximum employee plan contribution percentage of compensation | 50.00% | ||
Company plan contributions | $ 590 | $ 519 | $ 392 |
Leases - Additional Information
Leases - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Leases [Abstract] | |||
Rent expense | $ 656 | $ 680 | $ 672 |
Leases - Summary of Future Mini
Leases - Summary of Future Minimum Lease Payments (Detail) $ in Thousands | Dec. 31, 2017USD ($) |
Operating Leases Future Minimum Payments Due [Abstract] | |
2,018 | $ 623 |
2,019 | 566 |
2,020 | 233 |
2,021 | 238 |
2,022 | 60 |
Total future minimum lease payments | $ 1,720 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | |||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Operating Loss Carryforwards [Line Items] | ||||
U.S. federal statutory tax rate | 34.00% | 34.00% | 34.00% | |
Provisional estimate of reduction in deferred tax assets | $ 24,196,000 | |||
Provisional estimate of reduction in valuation allowance | $ 24,196,000 | |||
Period of incurred losses for both book and tax purposes | 3 years | |||
Valuation allowance for deferred tax assets | $ 52,038,000 | $ 67,758,000 | ||
Increased and decreased total valuation allowance | 15,720,000 | 8,864,000 | ||
Deferred tax assets, net of valuation allowances | 0 | 0 | ||
Net operating loss carry forward unused amount | 428,000 | |||
Unrecognized tax benefits | 0 | 0 | ||
Interest or penalties charged in relation to unrecognized tax benefits | 0 | 0 | ||
Interest or penalties accrued in relation to unrecognized tax benefits | $ 0 | $ 0 | ||
Total unrecognized tax benefits changing period | 12 months | |||
U.S Federal Tax [Member] | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carry forward | $ 176,069,000 | |||
Research credit carryforward | 5,617,000 | |||
Foreign Tax Authority [Member] | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carry forward | $ 454,000 | |||
Tax credit carryforward expiration year | 2,018 | |||
Maximum [Member] | ||||
Operating Loss Carryforwards [Line Items] | ||||
U.S. federal statutory tax rate | 35.00% | |||
Maximum [Member] | U.S Federal Tax [Member] | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforward expiration year | 2,037 | |||
Tax credit carryforward expiration year | 2,037 | |||
Minimum [Member] | U.S Federal Tax [Member] | ||||
Operating Loss Carryforwards [Line Items] | ||||
Net operating loss carryforward expiration year | 2,018 | |||
Tax credit carryforward expiration year | 2,018 | |||
Scenario, Plan [Member] | ||||
Operating Loss Carryforwards [Line Items] | ||||
U.S. federal statutory tax rate | 21.00% |
Income Taxes - Schedule of Inco
Income Taxes - Schedule of Income (Loss) before Income Tax Domestic and Foreign (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income (Loss) from Continuing Operations before Equity Method Investments, Income Taxes, Extraordinary Items, Noncontrolling Interest [Abstract] | |||
Income (loss) before income taxes, US | $ (16,762) | $ (24,229) | $ (21,831) |
Income (loss) before income taxes, Switzerland | 19 | (10) | 1,347 |
Net loss before income taxes | $ (16,743) | $ (24,239) | $ (20,484) |
Income Taxes - Summary of Effec
Income Taxes - Summary of Effective Tax Rates Differ from Statutory Income Tax Rates (Detail) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Effective Income Tax Rate Reconciliation, Percent [Abstract] | |||
Statutory income tax rate | (34.00%) | (34.00%) | (34.00%) |
State income taxes | (6.10%) | (6.80%) | (5.70%) |
Valuation allowance increase | (102.00%) | 35.90% | 35.20% |
Effect of foreign operations | (1.30%) | ||
Change in unused net operating loss and credit carryforwards | (4.00%) | 3.70% | 2.80% |
Nondeductible items | 1.60% | 1.60% | 3.90% |
Impact of Tax Cuts and Jobs Act | 144.50% | ||
Effective income tax rate, Total | (0.00%) | 0.40% | 0.90% |
Income Taxes - Summary of Defer
Income Taxes - Summary of Deferred Tax Assets (Liabilities) (Detail) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Gross deferred tax assets: | ||
Net operating loss carryforward – U.S. | $ 43,046,000 | $ 58,206,000 |
Net operating loss carryforward – Switzerland | 67,000 | 65,000 |
Research and development tax credit carryforward | 6,153,000 | 5,477,000 |
Deferred revenue | 339,000 | 438,000 |
Stock-based compensation | 1,882,000 | 2,678,000 |
Inventory reserve | 140,000 | 364,000 |
Compensation accruals | 662,000 | 996,000 |
Other | 575,000 | 378,000 |
Deferred tax asset, Total | 52,864,000 | 68,602,000 |
Gross deferred tax liabilities – depreciation and amortization | (826,000) | (844,000) |
Less valuation allowance | (52,038,000) | (67,758,000) |
Net deferred tax asset | $ 0 | $ 0 |
Significant Customers and Con52
Significant Customers and Concentrations of Risk - Summary of Revenues by Customer Location (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Concentration Risk [Line Items] | |||||||||||
Total revenues | $ 14,040 | $ 15,052 | $ 13,416 | $ 12,007 | $ 14,196 | $ 13,479 | $ 12,228 | $ 12,319 | $ 54,515 | $ 52,222 | $ 45,658 |
United States of America [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Total revenues | 48,924 | 45,531 | 39,229 | ||||||||
Europe [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Total revenues | 5,061 | 6,117 | 6,026 | ||||||||
Other [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Total revenues | $ 530 | $ 574 | $ 403 |
Significant Customers and Con53
Significant Customers and Concentrations of Risk - Summary of Significant Customers from which the Company Derived 10% or More of Total Revenue (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | ||
Concentration Risk [Line Items] | ||||||||||||
Total revenues | $ 14,040 | $ 15,052 | $ 13,416 | $ 12,007 | $ 14,196 | $ 13,479 | $ 12,228 | $ 12,319 | $ 54,515 | $ 52,222 | $ 45,658 | |
Teva [Member] | ||||||||||||
Concentration Risk [Line Items] | ||||||||||||
Total revenues | 20,949 | 24,941 | 17,715 | |||||||||
AMAG [Member] | ||||||||||||
Concentration Risk [Line Items] | ||||||||||||
Total revenues | 8,965 | 4,446 | 365 | |||||||||
McKesson [Member] | ||||||||||||
Concentration Risk [Line Items] | ||||||||||||
Total revenues | [1] | 8,707 | 7,600 | 6,837 | ||||||||
AmerisourceBergen [Member] | ||||||||||||
Concentration Risk [Line Items] | ||||||||||||
Total revenues | [1] | 6,098 | 4,903 | 4,527 | ||||||||
Ferring [Member] | ||||||||||||
Concentration Risk [Line Items] | ||||||||||||
Total revenues | $ 5,258 | $ 6,283 | 6,117 | |||||||||
LEO Pharma [Member] | ||||||||||||
Concentration Risk [Line Items] | ||||||||||||
Total revenues | $ 6,000 | |||||||||||
[1] | Revenue net of estimated sales returns and allowances based on OTREXUP® shipments to the distributor. |
Legal Proceedings - Additional
Legal Proceedings - Additional Information (Detail) | Dec. 31, 2017Patent |
Commitments And Contingencies Disclosure [Abstract] | |
Number of patents | 2 |
Quarterly Financial Data (una55
Quarterly Financial Data (unaudited) - Quarterly Financial Data (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Selected Quarterly Financial Information [Abstract] | |||||||||||
Total revenues | $ 14,040 | $ 15,052 | $ 13,416 | $ 12,007 | $ 14,196 | $ 13,479 | $ 12,228 | $ 12,319 | $ 54,515 | $ 52,222 | $ 45,658 |
Gross profit | 6,932 | 6,529 | 7,800 | 5,788 | 7,507 | 5,445 | 4,910 | 5,543 | 27,049 | 23,405 | 26,200 |
Net loss | $ (3,714) | $ (5,453) | $ (2,840) | $ (4,736) | $ (4,500) | $ (6,121) | $ (6,061) | $ (7,656) | $ (16,743) | $ (24,339) | $ (20,659) |
Net loss per common share | $ (0.02) | $ (0.03) | $ (0.02) | $ (0.03) | $ (0.03) | $ (0.04) | $ (0.04) | $ (0.05) | |||
Weighted average shares | 156,654,843 | 156,400,702 | 155,926,149 | 155,215,040 | 155,111,435 | 155,060,811 | 154,936,096 | 154,858,079 |