Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Mar. 01, 2019 | Jun. 30, 2018 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2018 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | ATRS | ||
Entity Registrant Name | ANTARES PHARMA, INC. | ||
Entity Central Index Key | 0001016169 | ||
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 Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 160,532,311 | ||
Entity Public Float | $ 374,318,627 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Current Assets: | ||
Cash and cash equivalents | $ 27,892,000 | $ 26,562,000 |
Short-term investments | 0 | 4,993,000 |
Accounts receivable | 18,976,000 | 11,878,000 |
Inventories | 11,350,000 | 9,275,000 |
Contract assets | 10,442,000 | 505,000 |
Prepaid expenses and other current assets | 2,648,000 | 2,323,000 |
Total current assets | 71,308,000 | 55,536,000 |
Equipment, molds, furniture and fixtures, net | 14,895,000 | 16,158,000 |
Intangibles, net | 831,000 | 1,401,000 |
Goodwill | 1,095,000 | 1,095,000 |
Other assets | 148,000 | 148,000 |
Total Assets | 88,277,000 | 74,338,000 |
Current Liabilities: | ||
Accounts payable | 11,135,000 | 5,957,000 |
Accrued expenses and other liabilities | 11,997,000 | 6,982,000 |
Long-term debt, current portion | 3,043,000 | |
Deferred revenue | 1,018,000 | 2,794,000 |
Total current liabilities | 27,193,000 | 15,733,000 |
Long-term debt | 22,083,000 | 24,858,000 |
Deferred revenue – long term | 200,000 | |
Total liabilities | 49,276,000 | 40,791,000 |
Commitments and contingencies (Note 12) | ||
Stockholders’ Equity: | ||
Preferred Stock: $0.01 par, authorized 3,000 shares, none outstanding | ||
Common Stock: $0.01 par; authorized 300,000 shares; 159,721 and 156,675 issued and outstanding at December 31, 2018 and 2017, respectively | 1,597,000 | 1,567,000 |
Additional paid-in capital | 314,907,000 | 302,965,000 |
Accumulated deficit | (276,800,000) | (270,285,000) |
Accumulated other comprehensive loss | (703,000) | (700,000) |
Total Stockholders' Equity | 39,001,000 | 33,547,000 |
Total Liabilities and Stockholders’ Equity | $ 88,277,000 | $ 74,338,000 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
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 | 159,721,000 | 156,675,000 |
Common Stock, shares outstanding | 159,721,000 | 156,675,000 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenue: | |||
Total revenue | $ 63,554 | $ 54,515 | $ 52,222 |
Cost of revenue: | |||
Total cost of revenue | 31,065 | 27,466 | 28,817 |
Gross profit | 32,489 | 27,049 | 23,405 |
Operating expenses: | |||
Research and development | 12,328 | 11,854 | 19,592 |
Selling, general and administrative | 36,762 | 31,646 | 27,930 |
Total operating expenses | 49,090 | 43,500 | 47,522 |
Gain on sale of assets | 12,500 | 860 | |
Operating loss | (4,101) | (15,591) | (24,117) |
Other income (expense): | |||
Interest expense | (2,675) | (1,423) | |
Other, net | 261 | 271 | (122) |
Total other expense | (2,414) | (1,152) | (122) |
Net loss before income taxes | (6,515) | (16,743) | (24,239) |
Income tax provision | 100 | ||
Net loss | $ (6,515) | $ (16,743) | $ (24,339) |
Basic and diluted net loss per common share | $ (0.04) | $ (0.11) | $ (0.16) |
Basic and diluted weighted average common shares outstanding | 157,407 | 156,054 | 154,992 |
Product sales [Member] | |||
Revenue: | |||
Total revenue | $ 47,870 | $ 41,695 | $ 40,318 |
Cost of revenue: | |||
Total cost of revenue | 29,094 | 22,317 | 23,909 |
Licensing and Development Revenue [Member] | |||
Revenue: | |||
Total revenue | 6,753 | 11,171 | 10,401 |
Royalties [Member] | |||
Revenue: | |||
Total revenue | 8,931 | 1,649 | 1,503 |
Cost of development revenue [Member] | |||
Cost of revenue: | |||
Total cost of revenue | $ 1,971 | $ 5,149 | $ 4,908 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Statement Of Income And Comprehensive Income [Abstract] | |||
Net loss | $ (6,515) | $ (16,743) | $ (24,339) |
Foreign currency translation adjustment | (3) | 15 | (23) |
Comprehensive loss | $ (6,518) | $ (16,728) | $ (24,362) |
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, 2015 | $ 67,042 | $ 1,548 | $ 295,292 | $ (229,106) | $ (692) |
Balance, shares at Dec. 31, 2015 | 154,849,000 | ||||
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 | 216,000 | ||||
Exercise of options | 101 | $ 1 | 100 | ||
Exercise of options, shares | 103,000 | ||||
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 | 155,168,000 | ||||
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 | 196,000 | ||||
Exercise of options | 1,816 | $ 13 | 1,803 | ||
Exercise of options, shares | 1,311,000 | ||||
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 | 156,675,000 | ||||
Issuance of common stock | 7,114 | $ 21 | 7,093 | ||
Issuance of common stock, shares | 2,137,000 | ||||
Common stock issued under equity compensation plan, net of shares withheld for taxes | (543) | $ 5 | (548) | ||
Common stock issued under equity compensation plan, net of shares withheld for taxes, shares | 462,000 | ||||
Exercise of options | 474 | $ 4 | 470 | ||
Exercise of options, shares | 447,000 | ||||
Share-based compensation | 4,927 | 4,927 | |||
Net loss | (6,515) | (6,515) | |||
Other comprehensive income (loss) | (3) | (3) | |||
Balance at Dec. 31, 2018 | $ 39,001 | $ 1,597 | $ 314,907 | $ (276,800) | $ (703) |
Balance, shares at Dec. 31, 2018 | 159,721,000 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Cash flows from operating activities: | |||
Net loss | $ (6,515) | $ (16,743) | $ (24,339) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Share-based compensation expense | 4,927 | 3,490 | 2,520 |
Depreciation and amortization | 2,724 | 2,104 | 1,861 |
Gain on sale of assets | (12,500) | (860) | |
Loss on disposal of equipment | 22 | 262 | |
Increase in inventory reserve | 592 | 356 | 748 |
Accretion of interest expense | 210 | 119 | |
Other | 51 | 46 | 12 |
Changes in operating assets and liabilities: | |||
Accounts receivable | (7,099) | (2,798) | (1,138) |
Inventories | (2,667) | (4,304) | (351) |
Contract assets | (4,937) | 1,268 | (574) |
Prepaid expenses and other current assets | (324) | (942) | 1,922 |
Other assets | (94) | 100 | |
Accounts payable | 5,164 | (1,522) | 2,859 |
Accrued expenses and other liabilities | 5,029 | 1,122 | (582) |
Deferred revenue | (1,977) | (4,358) | 1,505 |
Net cash used in operating activities | (17,322) | (23,094) | (15,195) |
Cash flows from investing activities: | |||
Purchases of equipment, molds, furniture and fixtures | (854) | (1,167) | (4,880) |
Additions to patent rights | (40) | (101) | (127) |
Proceeds from sale of assets, net of transaction costs | 7,500 | 1,901 | |
Proceeds from maturities of investment securities | 5,000 | 5,000 | 15,000 |
Purchases of investment securities | (9,964) | ||
Net cash provided by (used in) investing activities | 11,606 | (4,331) | 9,993 |
Cash flows from financing activities: | |||
Proceeds from issuance of long-term debt | 25,000 | ||
Payment of debt issuance costs | (294) | ||
Proceeds from issuance of common stock, net | 7,114 | ||
Proceeds from exercise of stock options | 474 | 1,816 | 101 |
Taxes paid related to net share settlement of equity awards | (543) | (249) | (84) |
Net cash provided by financing activities | 7,045 | 26,273 | 17 |
Effect of exchange rate changes on cash | 1 | (1) | 1 |
Net increase (decrease) in cash and cash equivalents | 1,330 | (1,153) | (5,184) |
Cash and cash equivalents: | |||
Beginning of year | 26,562 | 27,715 | 32,899 |
End of year | 27,892 | 26,562 | 27,715 |
Supplemental disclosure of non-cash investing activities: | |||
Gain on sales of assets recognized in excess of cash received | 5,000 | ||
Purchases of equipment, molds, furniture and fixtures recorded in accounts payable and accrued expenses | $ 49 | 40 | 424 |
Additions to patent rights recorded in accounts payable and accrued expenses | $ 10 | $ 45 |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Description of Business | 1. Description of Business Antares Pharma, Inc. (“Antares” or the “Company”) is a combination drug device company focused primarily on the development and commercialization of self-administered parenteral pharmaceutical products and technologies. The Company develops and commercializes, for itself or with partners, novel therapeutic products using its advanced drug delivery technology to enhance existing drug compounds and delivery methods. The Company’s intramuscular and subcutaneous injection technology platforms include the VIBEX ® ® ® The Company developed XYOSTED TM TM The Company also 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. Sumatriptan Injection USP was launched for commercial sale in June 2016. In collaboration with AMAG, the Company developed a subcutaneous auto injector for use with AMAG’s progestin hormone drug Makena ® ® Through a license, development and supply agreement with Teva, Antares developed and is the exclusive supplier of the device for Teva’s generic epinephrine auto injector product indicated for emergency treatment of severe allergic reactions in adults and certain pediatric patients. The product was approved by the FDA in August 2018 and launched for commercial sale in late fourth quarter of 2018. The Company is also developing two multi-dose pen injector products in collaboration with Teva, a combination drug device rescue pen in collaboration with Pfizer, and has other ongoing internal research and development programs. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
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 most significant accounting estimates relate to revenue recognition, inventory valuation, and the valuation of equity instruments used in stock-based compensation. Actual results could differ from these estimates. Revisions of Prior Period Financial Statements During the preparation of the consolidated financial statements for the year ended December 31, 2018, management revised the prior period consolidated financial statements to correct the presentation of certain regulatory fees between research and development expenses and selling, general and administrative expenses. As a result, the Company revised its consolidated statements of operations for the years ended December 31, 2017 and 2016 with an increase in selling, general and administrative expenses of $1,293 and $1,535, respectively, and a corresponding decrease to research and development expenses. These revisions had no impact on the Company’s total operating expenses or net loss. The revisions also had no impact on the consolidated balance sheets or the consolidated statements of comprehensive loss, stockholders’ equity or cash flows. The Company also revised the presentation of the gain on sale of assets in the consolidated statement of operations for the year ended December 31, 2017 to be included in the subtotal of operating loss. The change in presentation resulted in a decrease in operating loss and a corresponding increase in total other expense of $860, respectively, for the year ended December 31, 2017. The revisions had no impact on the Company’s net loss, and had no impact on the consolidated balance sheets or the consolidated statements of comprehensive loss, stockholders’ equity or cash flows as of and for the year ended December 31 2017. Management evaluated the materiality of the revisions from a quantitative and qualitative perspective and concluded that the revisions are immaterial to the consolidated financial statements. Accounting Pronouncements Recently Adopted On January 1, 2018, the Company adopted Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606) Effect of Balance / Total Balance / Total Change Without Adoption as Reported Higher/(Lower) of ASC 606 Balance Sheet: Inventories $ 11,350 $ 4,226 $ 15,576 Contract assets 10,442 (4,757 ) 5,685 Total current assets 71,308 (531 ) 70,777 Total assets 88,277 (531 ) 87,746 Accrued expenses and other liabilities 11,997 (1,029 ) 10,968 Deferred revenue 1,018 1,677 2,695 Total current liabilities 27,193 648 27,841 Total liabilities 49,276 648 49,924 Total liabilities and stockholders' equity 88,277 (531 ) 87,746 Statement of Operations: Total revenue $ 63,554 $ (5,405 ) $ 58,149 Total cost of revenue 31,065 (4,226 ) 26,839 Gross profit 32,489 (1,179 ) 31,310 Operating loss (4,101 ) (1,179 ) (5,280 ) Net loss (6,515 ) (1,179 ) (7,694 ) Net loss per share $ (0.04 ) $ (0.05 ) 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 In May 2017, the FASB issued ASU No. 2017-09, Compensation – Stock Compensation (Topic 718): Scope of Modification 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 Recent Accounting Pronouncements Not Yet Adopted as December 31, 2018 In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments 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 USD and are subject to foreign currency exchange rate fluctuations. Foreign currency transaction gains and losses are included in other income (expense) 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 From time to time, the Company has invested in U.S. Treasury bills and government agency notes that are classified as held-to-maturity because of the Company’s 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, 2018. Accounts Receivable Trade accounts receivable represents amounts billed to customers and 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 and changes in customer payment terms. At December 31, 2018, the Company’s trade accounts receivable balance was due primarily from Teva, AMAG and distributors. Each of these customers has historically paid timely and demonstrated creditworthiness. Accordingly, the Company believes the risk of accounts being uncollectible is minimal, and had no significant allowances for doubtful accounts established as of December 31, 2018 or 2017. If the financial condition of the Company’s customers were to deteriorate, adversely affecting their ability to make payments, additional allowances may be required. The Company had no bad debt expense in 2018, 2017 or 2016. Royalties receivable from partners are included in accounts receivable and are typically payable to the Company within 45 to 60 days after the end of each quarter and or annual period in which they were earned. 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, 2018 2017 Raw material $ 26 $ 118 Work in process 7,622 6,223 Finished goods 3,702 2,934 $ 11,350 $ 9,275 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 $847 and $510 at December 31, 2018 and 2017, respectively. In 2018, the Company wrote off inventory of $255 and increased the reserve for excess, dated or obsolete inventory by $592. In 2017, the Company wrote off $746 of inventory and increased the reserve for excess, dated or obsolete inventory by $356. Contract Assets Contract assets are recognized when control of goods or services has transferred to the customer, and corresponding revenue is recognized on an over time basis, but is not yet billable to the customer in accordance with the terms of the contract. Costs that have been incurred but not yet billed in connection with development services provided to partners are also recorded as contract assets. As of December 31, 2018, contract assets also include a $5,000 installment to be received in connection with the sale and transfer of assets to Ferring as discussed in Note 3. 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, 2018 2017 Furniture, fixtures and office equipment $ 2,331 $ 2,258 Production molds and equipment 19,678 15,322 Molds and tooling in process 456 4,023 Less accumulated depreciation (7,570 ) (5,445 ) $ 14,895 $ 16,158 Depreciation expense was $2,125, $1,536 and $1,326 for the years ended December 31, 2018, 2017 and 2016, respectively. In 2017, the Company sold certain assets, including molds and equipment, to Ferring, the net book value of which was $933. Intangible assets The Company capitalizes external legal costs and filing fees associated with obtaining patent rights for approved commercial and partnered products when there are projected future cash flows associated with the patent. These capitalized patent costs are 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 ranges 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 $3,794 and $2,963, respectively at December 31, 2018, and $3,772 and $2,371, respectively, at December 31, 2017. Patent amortization expense for the years ended December 31, 2018, 2017 and 2016 was $599, $568 and $534, 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 $353, $127, $89, $82 and $68 in 2019, 2020, 2021, 2022 and 2023, respectively. In 2017, the Company sold certain assets, including patent rights, to Ferring. The net book value of the patents sold was $108. 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, 2018 and 2017, 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, 2018, 2017, and 2016, respectively. Revenue Recognition The Company generates revenue from proprietary and partnered product sales, license and development activities and royalty arrangements. Revenue is recognized when or as the Company transfers control of the promised goods or services to its customers at the transaction price, which is the amount that reflects the consideration to which it expects to be entitled to in exchange for those goods or services. At inception of each contract, the Company identifies the goods and services that have been promised to the customer and each of those that represent a distinct performance obligation, determines the transaction price including any variable consideration, allocates the transaction price to the distinct performance obligations and determines whether control transfers to the customer at a point in time or over time. Variable consideration is included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company reassess its reserves for variable consideration at each reporting date and makes adjustments, if necessary, The Company has elected to recognize the cost for freight and shipping activities as fulfilment cost. Amounts billed to customers for shipping and handling are included as part of the transaction price and recognized as revenue when control of underlying goods are transferred to the customer. The related shipping and freight charges incurred by the Company are included in cost of revenue. Proprietary Product Sales The Company sells its proprietary products OTREXUP ® TM The determination of certain of these reserves and sales allowances require management to make a number of judgements and estimates to reflect the Company’s best estimate of the transaction price and the amount of consideration to which it believes it is ultimately entitled to receive. The expected value is determined based on unit sales data, contractual terms with customers and third-party payers, historical and expected utilization rates, any new or anticipated changes in programs or regulations that would impact the amount of the actual rebates, customer purchasing patterns, product expiration dates and levels of inventory in the distribution channel. Reserves for prompt payment discounts are recorded as a reduction in accounts receivable. Reserves for returns, distributor fees, rebates and customer co-pay support programs are included within current liabilities in our consolidated balance sheets. Wholesaler Distribution Fees . Distribution fees are paid to certain wholesalers based on contractually determined rates and units purchased. S ince the fee paid to the customer is not for a distinct good or service, the consideration is recognized as a reduction of the transaction price of the goods delivered in accordance with ASC 606. The Company accrues the estimated fee due at the time of sale based on the contracted price and adjusts the accrual at each reporting period, if necessary, to reflect actual experience. Prompt Pay Discounts . The Company offers cash discounts to its customers, generally 2% of the sales price, as an incentive for prompt payment. Based on historical experience, customers take advantage of this discount and accordingly the Company accrues 100% of the cash discounts offered by reducing accounts receivable and recognizing the discount as a reduction of revenue in the same period the related sales are made. The accrual is reviewed at each reporting period and adjusted if actual experience differs from estimates. 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 plan 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 also offers discount cards, co-pay coupons and free trial programs to off-set the cost of prescriptions to patients. The Company estimates the total amount that will be redeemed or utilized based on historical redemption experience and on levels of inventory in the distribution and retail channels and recognizes the discount as a reduction of revenue in the same period the related revenue is recognized. Product Returns. Consistent with industry practice, the Company generally offers wholesalers and specialty distributors a limited right to return products, generally within six months prior to and 12 months following the product’s expiration date. The Company’s propriety products generally have expiration dates ranging from 24 to 33 months. Product returns are estimated and recorded at the time of sale based on historical return patterns. Actual returns are tracked by individual production lots and charged against reserves. Returns reserves may be adjusted, if necessary, if actual returns differ from historical estimates. Management also monitors and takes into consideration the amount of estimated product inventory in the distribution channel, product dating and any known or expected changes in the marketplace when establishing is estimated rate of returns. The Company has limited historical sales and returns experience for its newly launched product XYOSTED TM TM adjustments Prior to the first quarter of 2017, in accordance with ASC 605 and industry practice, recognition of revenue related to proprietary product sales was deferred until rights of return no longer existed, which occurred at the earlier of the time units were dispensed through patient prescriptions or expiration of the right of return of the product, as the Company had limited sales and returns history for proprietary products and could not reliably estimate expected returns in accordance with revenue recognition standards at the time. However, in the first quarter of 2017, the Company determined it had developed sufficient historical information to reasonably estimate potential returns and began recognizing revenue, net of estimated returns, upon delivery to the distributors. As a result, the Company recognized an additional $1,297 for product shipped to distributors in previous periods that had not been previously recognized as revenue at the time of shipment, net of the returns allowance established in the first quarter of 2017. The Company also recognized $254 of related product costs that had been previously deferred. The net impact of these changes resulted in a reduction in net loss of $1,043, which was less than $0.01 per share, for the year ended December 31, 2017. The adoption of ASC 606 on January 1, 2018 had no impact on the amount and timing of revenue recognition and related sales reserves and allowances for OTREXUP ® TM The following presents changes in reserves for product returns and sales allowances: Patient Wholesaler Prompt Rebates and Discount Distribution Payment Chargebacks Programs Returns Fees Discounts Balance at December 31, 2016 $ 1,012 $ 81 $ — $ 391 $ 57 Accruals and adjustments 6,848 1,027 1,128 2,864 570 Payments and other reserve reductions (6,545 ) (993 ) (883 ) (2,790 ) (543 ) Balance at December 31, 2017 1,315 115 245 465 84 Accruals and adjustments 9,586 2,429 1,628 3,519 742 Payments and other reserve reductions (8,207 ) (1,254 ) (720 ) (3,194 ) (610 ) Balance at December 31, 2018 $ 2,694 $ 1,290 $ 1,153 $ 790 $ 216 Partnered Product Sales The Company is party to several license, development, supply and distribution arrangements with pharmaceutical partners, under which the Company produces and is the exclusive supplier of certain products, devices and/or components. Revenue is recognized when or as control of the goods transfers to the customer as follows: The Company is the exclusive supplier of the Makena ® All other partnered product sales are recognized at the point in time in which control is transferred to the customer, which is typically upon shipment. Sales terms and pricing are governed by the respective supply and distribution agreements, and there is generally no price protection or right of return. Revenue is recognized at the transaction price, which includes the contractual per unit selling price and estimated variable consideration, if any. For example, the Company sells Sumatriptan Injection USP to Teva at cost and is 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. The Company recognizes revenue, including the estimated variable consideration it expects to receive for contract margin on future commercial sales, upon shipment of the goods to Teva. The estimated variable consideration is recognized at an amount the Company believes is not subject to significant reversal based on historical experience, and is adjusted at each reporting period if the most likely amount of expected consideration changes or becomes fixed. Licensing and Development Revenue The Company has entered into several license, development and supply arrangements with pharmaceutical partners under which the Company grants a license to its device technology and know-how and provides research and development services that often involve multiple performance obligations and highly customized deliverables. For such arrangements, the Company identifies each of the promised goods and services within the contract and the distinct performance obligations at inception, and allocates consideration to each performance obligation based on relative standalone selling price, which is generally determined based on the expected cost plus margin. If the contract includes an enforceable right to payment for performance completed to date and performance obligations are satisfied over time, the Company recognized revenue over the development period using either the input or output method depending on which is most appropriate given the nature of the distinct deliverable. For other contracts that do not contain an enforceable right to payment for performance completed to date, revenue is recognized when control is transferred to the customer. Factors that may indicate that the transfer of control has occurred include the transfer of legal title, transfer of physical possession, the customer has obtained the significant risks and rewards of ownership of the assets and the Company has a present right to payment. The Company’s typical payment terms for development contracts may include an upfront payment equal to a percentage of the total contract value with the remaining portion to be billed upon completion and transfer of the individual deliverables or satisfaction of the individual performance obligations. The Company records a liability for cash received in advance of performance, which is presented within deferred revenue on the consolidated balance sheet and recognized as revenue when the associated performance obligations have been satisfied. License fees and milestones received in exchange for the grant of a license to the Company’s functional intellectual property (“IP”) such as patented technology and know-how in connection with a partnered development arrangement are generally recognized at inception of the arrangement, or over the development period depending on the facts and circumstances, as the license is not generally distinct from the non-licensed goods or services to be provided under the contract. Milestone payments that are contingent upon the occurrence of future events, are evaluated and recorded at the most likely amount, and to the extent that it is probable that a significant reversal will not occur when the associated uncertainty is resolved. Royalties The Company earns royalties in connection with licenses granted under license and development arrangements with partners. Royalties are based upon a percentage of commercial sales of partnered products with rates ranging from mid single digit to low double digit and are tiered based on levels of net sales. These sales-based royalties, for which the license was deemed the predominant element to which the royalties relate, are estimated and recognized in the period in which the partners’ commercial sales occur. The royalties are generally reported and payable to the Company within 45 to 60 days of the end of the period in which the commercial sales are made. The Company bases its estimates of royalties earned on actual sales information from its partners when available or estimated prescription sales from external sources and estimated net selling price. If actual royalties received are different than amounts estimated, the Company would adjust the royalty revenue in the period in which the adjustment becomes known. Remaining Performance Obligations Remaining performance obligations represents the transaction price of firm orders and development contract deliverables for which work has not been completed or orders fulfilled, and excludes potential purchase orders under ordering-type supply contracts with indefinite delivery or quantity. As of December 31, 2018, the aggregate value of remaining performance obligations, excluding contracts with an original expected length of one year or less, was $5.3 million. The Company expects to recognize revenue on the remaining performance obligations over the next three years, with the majority being recognized in the next twelve months. 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 statements 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 impact the estimated fair value of the stock option awards. 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. 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. |
Sale of Assets
Sale of Assets | 12 Months Ended |
Dec. 31, 2018 | |
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 International Center S.A (together with Ferring Pharmaceuticals Inc. and Ferring B.V. individually and collectively referred to as “Ferring”) to sell the worldwide rights, including certain assets, related to the needle-free auto injector device product line for a total purchase price of $14.5 million. The purchase price was 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; 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”). 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 In 2018, the Company satisfied additional conditions of the transaction and received the second and third installments totaling $7,500. The second and third installments are potentially refundable to Ferring under certain circumstances if completion of the transaction does not occur within a specified timeframe, or at all. However, as of December 31, 2018, management determined that based on the satisfaction of certain conditions and the status of remaining closing requirements it became probable that a significant reversal of the gain will not occur and recognized the remaining gain on sale of assets of $12,500 in accordance with ASC 610-20, which would have been deferred until the Completion Date under previous accounting standards. The final installment of $5,000 is recorded as a contract asset in the consolidated balance sheet will become payable to the Company on the Completion Date, which is expected to occur in 2019. 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, 2018 | |
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 $25.0 million (the “Term Loan”), the proceeds of which are to be used for working capital and general corporate purposes. The Term Loan is secured by substantially all of the Company’s assets, excluding intellectual property, and will mature on July 1, 2022. Interest accrues at a calculated prime-based variable rate with a maximum interest rate of 9.50%, which was the rate as of December 31, 2018. Payments under the Loan Agreement are interest only until the first principal payment is due on August 1, 2019. The Loan Agreement also requires the Company to pay a fee equal to 4.25% of the total original principal amount (“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, 2018, and 2017, the carrying value of the Term Loan was $25,126 and $24,858, respectively, which consisted of the $25,000 principal balance outstanding and the End of Term Charge accrual, less unamortized debt issuance costs that are being amortized/accrued to interest expense over the term of the Term Loan using the effective interest method. The Company paid $2,353 and $1,080 in interest payments for the years ended December 31, 2018 and 2017, respectively. Future principal payments under the term loan, including the contractual End of Term Charge, are as follows: 2019 $ 3,043 2020 7,830 2021 8,624 2022 6,566 $ 26,063 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2018 | |
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 “Offering”.) The Company pays a commission of 3.0% of the gross sales proceeds of any common stock sold through Cowen under the Sales Agreement. The Company issued 2,137 shares of common stock pursuant to the Offering and Sales Agreement during the year ended December 31, 2018. The sale of common stock resulted in aggregate gross proceeds of $7,555, less sales commission and payment of offering costs, resulting in net offering proceeds to the Company of $7,114. No sales of common stock were made in the period ended December 31, 2017. The net proceeds are intended to be used for general corporate purposes including, but not limited to, product commercialization, research and development projects, funding of clinical trials, capital expenditures and working capital. |
Share Based Compensation
Share Based Compensation | 12 Months Ended |
Dec. 31, 2018 | |
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 and the maximum number of shares of stock that may be granted to any one participant during a calendar year is 4,000 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, 2018, the Plan had approximately 2,960 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, 2018 is as follows: Weighted Weighted Average Average Remaining Aggregate Number of Exercise Contractual Intrinsic Shares Price ($) Term (Years) Value ($) Outstanding at December 31, 2015 9,480 2.19 Granted/Issued 4,030 1.14 Exercised (142 ) 1.23 122 Cancelled/Forfeited (2,054 ) 2.13 Outstanding at December 31, 2016 11,314 1.84 Granted/Issued 2,986 2.67 Exercised (1,311 ) 1.38 2,226 Cancelled/Forfeited (840 ) 2.68 Outstanding at December 31, 2017 12,149 2.04 Granted/Issued 2,693 2.72 Exercised (477 ) 1.14 768 Cancelled/Forfeited (286 ) 2.43 Outstanding at December 31, 2018 14,079 2.19 6.8 8,534 Exercisable at December 31, 2018 10,556 2.07 6.1 7,834 The per share weighted average fair value of options granted during 2018, 2017 and 2016 was estimated as $1.45, $1.37 and $0.57, 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, 2018 2017 2016 Risk-free interest rate 2.8 % 1.8 % 1.3 % Annualized volatility 53.7 % 53.3 % 51.7 % Weighted average expected life, in years 6.0 6.0 6.0 Expected dividend yield 0.0 % 0.0 % 0.0 % Option exercises during 2018, 2017 and 2016 resulted in proceeds of $474, $1,816 and $101, respectively, and in the issuance of shares of common stock of 447 in 2018, 1,311 in 2017 and 103 in 2016. In 2018 and 2016, certain options were net exercised, whereby the Company withheld 30 and 40 shares, respectively, the fair value of which was equivalent to the aggregate exercise price and tax withholding on the date of exercise. Compensation expense related to stock option awards was $2,956, $2,378 and $2,039 in 2018, 2017 and 2016, respectively. As of December 31, 2018, there was $4,440 of total unrecognized compensation costs related to non-vested outstanding stock options that are expected to be recognized over a weighted average period of approximately 1.8 years. Long Term Incentive Program The Company’s Board of Directors has approved a long term incentive program (“LTIP”) for the benefit of the Company’s senior executives. Pursuant to the LTIP, the Company’s senior executives are awarded stock options, restricted stock units (“RSU”) and performance stock units (“PSU”) with targeted values based on similar award structures granted by the Company’s peer group. The stock options have a ten-year term, have an exercise price equal to the closing price of the Company’s common stock on the date of grant, vest in quarterly installments over three years, were otherwise granted on the same standard terms and conditions as other stock options granted pursuant to the Plan and are included in the stock options table above. The RSUs vest in three equal annual installments, and the PSU awards vest and convert into shares of the Company’s common stock based on the Company’s attainment of certain performance goals over a performance period, which is typically three years. The performance stock unit awards and restricted stock unit awards granted under the long term incentive program are summarized in the following table: Performance Stock Units Restricted Stock Units Number of Shares Weighted Average Date Fair Value ($) Number of Shares Weighted Average Grant Date Fair Value ($) Outstanding at December 31, 2015 956 2.40 715 2.32 Granted 751 1.15 751 1.12 Vested/settled (17 ) 3.96 (264 ) 2.41 Forfeited/expired (343 ) 2.17 (379 ) 1.91 Outstanding at December 31, 2016 1,347 1.50 823 1.39 Granted 689 3.12 689 2.69 Vested/settled — (288 ) 1.49 Forfeited/expired (581 ) 2.16 (67 ) 1.70 Outstanding at December 31, 2017 1,455 2.20 1,157 2.12 Granted 611 2.89 611 2.70 Vested/settled (173 ) 2.18 (500 ) 1.99 Forfeited/expired (51 ) 3.01 (42 ) 2.68 Outstanding at December 31, 2018 1,842 2.41 1,226 2.44 The outstanding balance of PSU awards is stated at the target number of shares to be awarded upon attainment of certain performance goals. Depending on the outcome of the related performance goals, a recipient may ultimately earn a number of shares that is greater or less than the target number of units granted, ranging from 0% to 150%. The balance of PSU awards outstanding as of December 31, 2018 included 593 units granted in 2016 with a performance period ended December 31, 2018 that were subsequently deemed to be achieved and approved for settlement in the first quarter of 2019 for a total of 415 shares. In each of the years in the three-year period ended December 31, 2018, 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. The fair values of the TSR PSUs granted were determined using a Monte Carlo simulation and utilized the following inputs and assumptions: 2018 Award 2017 Award 2016 Award Closing stock price on grant date $ 2.70 $ 2.66 $ 1.12 Performance period starting price $ 1.92 $ 2.17 $ 1.29 Term of award (in years) 2.57 2.57 2.58 Volatility 64.9 % 54.6 % 70.1 % Risk-free interest rate 2.56 % 1.39 % 0.97 % Expected dividend yield 0.00 % 0.00 % 0.00 % Fair value per TSR PSU $ 3.27 $ 3.10 $ 1.25 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. Other PSU awards that are not market-based awards are expensed using the grant date fair value of shares expected to vest over the remaining performance period when it becomes probable that the related performance goal will be achieved. Compensation expense recognized in connection with PSU awards, including both TSR based awards and awards with defined performance goals considered probable of achievement, was $798, $411 and $68 in 2018, 2017 and 2016, respectively. Compensation expense recognized in connection with the RSUs was $1,173, $701 and $413 in 2018, 2017 and 2016, respectively. LTIP awards are generally net-share settled such that the Company withholds shares with value equivalent to the employees’ minimum statutory obligation for the applicable income and other employment taxes, and remits cash to the appropriate taxing authorities. Total shares withheld for net-settled awards were 211, 98 and 74 in 2018, 2017 and 2016, 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 $543, $249 and $84 in 2018, 2017 and 2016, 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. |
Accrued Expenses and Other Liab
Accrued Expenses and Other Liabilities | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 2017 Accrued employee compensation and benefits $ 3,715 $ 2,470 Product returns and sales allowances 5,927 2,140 Other liabilities 2,355 2,372 $ 11,997 $ 6,982 |
Employee 401(k) Savings Plan
Employee 401(k) Savings Plan | 12 Months Ended |
Dec. 31, 2018 | |
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 a portion of their annual compensation into the plan up to the IRS annual limits. The Company has elected to make matching contributions to the plan based on a percentage of employee contributions. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2018 | |
Leases [Abstract] | |
Leases | 9. Leases As of December 31, 2018, the Company had 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. Rent expense incurred for the years ended December 31, 2018, 2017 and 2016 was $695, $656 and $680, respectively. Future minimum lease payments under operating leases as of December 31, 2018 were as follows: Amount 2019 $ 566 2020 233 2021 238 2022 60 2023 — Thereafter — Total future minimum lease payments $ 1,097 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
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”). ASC 740, Income Taxes, requires companies to recognize the effect of the tax law changes in the period of enactment. However, the SEC staff issued Staff Accounting Bulletin No. 118 (“SAB 118”) which allowed companies to record provisional amounts during a measurement period not extending beyond one year from the TJCA enactment date. For the years ended December 31, 2018 and 2017, the Company recognized income tax detriment related to the TCJA of $113 and $24,196, respectively, associated with the impact of remeasuring deferred tax assets due to the decreased U.S. federal corporate income tax rate and a corresponding reduction to its valuation allowance. As of December 31, 2018, the Company has completed the accounting for all impacts of the TCJA. The Company finalized its policy and elected to use the period cost method for GILTI provisions, and therefore has not recorded deferred taxes for basis differences expected to reverse in future periods. 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, 2018. The Company incurred losses for both book and tax purposes for the year ended December 31, 2018, and, accordingly, no income taxes were provided. Income (loss) before income taxes was derived from the following jurisdictions: 2018 2017 2016 U.S. $ (6,696 ) $ (16,762 ) $ (24,229 ) Switzerland 181 19 (10 ) $ (6,515 ) $ (16,743 ) $ (24,239 ) Effective tax rates differ from statutory income tax rates in the years ended December 31, 2018, 2017 and 2016 as follows: 2018 2017 2016 Statutory income tax rate (21.0 )% (34.0 )% (34.0 )% State income taxes (3.8 ) (6.1 ) (6.8 ) Valuation allowance increase 20.8 (102.0 ) 35.9 Effect of foreign operations (0.2 ) — — Change in unused net operating loss and credit carryforwards (3.9 ) 2.7 3.7 162(m) limitation 2.9 — — Nondeductible items 3.2 (5.1 ) 1.6 Impact of Tax Cuts and Jobs Act 2.0 144.5 — 0.0 % 0.0 % 0.4 % Deferred tax assets (liabilities) as of December 31, 2018 and 2017 consist of the following: 2018 2017 Gross deferred tax assets: Net operating loss carryforward – U.S. $ 42,966 $ 43,046 Net operating loss carryforward – Switzerland 7 67 Research and development tax credit carryforward 6,891 6,153 Deferred revenue 105 339 Stock-based compensation 2,324 1,882 Inventory reserve 440 140 Compensation accruals 904 662 163j interest expense limitation 438 — Amortization 562 429 Other 1,631 575 Total deferred tax assets 56,268 53,293 Deferred tax liabilities: Depreciation (1,511 ) (1,255 ) Installment obligations (1,363 ) — Total deferred tax liabilities (2,874 ) (1,255 ) Net deferred tax asset before valuation allowance 53,394 52,038 Less valuation allowance (53,394 ) (52,038 ) Net deferred tax asset $ — $ — The valuation allowance for deferred tax assets as of December 31, 2018 and 2017 was $53,394 and $52,038, respectively. The total valuation allowance increased $1,356 for the year ended December 31, 2018 and decreased $15,720 for the year ended December 31, 2017. At both December 31, 2018 and 2017, 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, 2018, 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, 2018 of $171,043, which, subject to limitations of Internal Revenue Code (“IRC”) Section 382, is available to reduce income taxes payable in future years. If not used, the portion of the carryforward generated before 2018 will expire in years 2019 through 2037, and the net operating loss carryforward generated in 2018 will carry forward indefinitely. Additionally, the Company has U.S. Research Credit carryforwards of $6,276. These credits expire in years 2019 through 2038. 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, 2018, of $48, which is available to reduce income taxes payable in future years. If not used, $48 of this carryforward will expire in 2023. As of December 31, 2018 and 2017, 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. |
Revenues, Significant Customers
Revenues, Significant Customers and Concentrations of Risk | 12 Months Ended |
Dec. 31, 2018 | |
Revenue From Contract With Customer [Abstract] | |
Revenues, Significant Customers and Concentrations of Risk | 11. Revenues, Significant Customers and Concentrations of Risk The following table presents the Company’s revenue on a disaggregated basis by major types and sources: For the Years Ended December 31, 2018 2017 2016 Proprietary product sales $ 17,532 $ 17,946 $ 15,145 Partnered product sales 30,338 23,749 25,173 Total product sales 47,870 41,695 40,318 Licensing and development revenue 6,753 11,171 10,401 Royalties 8,931 1,649 1,503 Total revenue $ 63,554 $ 54,515 $ 52,222 Revenues disaggregated by customer geographic location are summarized as follows: For the Years Ended December 31, 2018 2017 2016 United States of America $ 57,033 $ 48,924 $ 45,531 Europe 6,157 5,061 6,117 Other 364 530 574 $ 63,554 $ 54,515 $ 52,222 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, 2018 2017 2016 Teva $ 19,756 $ 20,949 $ 24,941 AMAG 18,121 8,965 4,446 McKesson (1) 7,338 8,707 7,600 AmerisourceBergen (1) 6,952 6,098 4,903 Ferring 7,023 5,258 6,283 (1) Revenue from sales to distributors, net of estimated sales returns and allowances based on shipments. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 12. Commitments and Contingencies 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 Smith Smith 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 Smith Clark Smith |
Quarterly Financial Data (unaud
Quarterly Financial Data (unaudited) | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Data (unaudited) | 13. First Second Third Fourth 2018 Total revenues $ 12,703 $ 14,162 $ 17,868 $ 18,821 Gross profit 5,517 7,202 10,579 9,191 Net income (loss) (6,193 ) (4,520 ) (1,936 ) 6,134 Net income (loss) per common share, basic and diluted (1) (0.04 ) (0.03 ) (0.01 ) 0.04 Weighted average shares (1) 156,724 157,024 157,471 158,389 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, basic and diluted (0.03 ) (0.02 ) (0.03 ) (0.02 ) Weighted average shares 155,215 155,926 156,401 156,655 (1) Net income (loss) per common share is computed based upon the net income or loss divided by the weighted average number of shares outstanding during each period. Basic and diluted income (loss) per share amounts were identical for the first, second and third quarters, respectively, as the effect of potential common shares were anti-dilutive. Weighted average shares on a fully diluted basis, taking into consideration the effects of dilutive stock options, restricted stock and performance stock awards, was 162,810 for the fourth quarter of 2018, which resulted in the income per share being the same on both a basic and diluted basis. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
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 most significant accounting estimates relate to revenue recognition, inventory valuation, and the valuation of equity instruments used in stock-based compensation. Actual results could differ from these estimates. |
Revisions of Prior Period Financial Statements | Revisions of Prior Period Financial Statements During the preparation of the consolidated financial statements for the year ended December 31, 2018, management revised the prior period consolidated financial statements to correct the presentation of certain regulatory fees between research and development expenses and selling, general and administrative expenses. As a result, the Company revised its consolidated statements of operations for the years ended December 31, 2017 and 2016 with an increase in selling, general and administrative expenses of $1,293 and $1,535, respectively, and a corresponding decrease to research and development expenses. These revisions had no impact on the Company’s total operating expenses or net loss. The revisions also had no impact on the consolidated balance sheets or the consolidated statements of comprehensive loss, stockholders’ equity or cash flows. The Company also revised the presentation of the gain on sale of assets in the consolidated statement of operations for the year ended December 31, 2017 to be included in the subtotal of operating loss. The change in presentation resulted in a decrease in operating loss and a corresponding increase in total other expense of $860, respectively, for the year ended December 31, 2017. The revisions had no impact on the Company’s net loss, and had no impact on the consolidated balance sheets or the consolidated statements of comprehensive loss, stockholders’ equity or cash flows as of and for the year ended December 31 2017. Management evaluated the materiality of the revisions from a quantitative and qualitative perspective and concluded that the revisions are immaterial to the consolidated financial statements. |
Recent Accounting Pronouncements | Accounting Pronouncements Recently Adopted On January 1, 2018, the Company adopted Financial Accounting Standards Board (“FASB”) Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606) Effect of Balance / Total Balance / Total Change Without Adoption as Reported Higher/(Lower) of ASC 606 Balance Sheet: Inventories $ 11,350 $ 4,226 $ 15,576 Contract assets 10,442 (4,757 ) 5,685 Total current assets 71,308 (531 ) 70,777 Total assets 88,277 (531 ) 87,746 Accrued expenses and other liabilities 11,997 (1,029 ) 10,968 Deferred revenue 1,018 1,677 2,695 Total current liabilities 27,193 648 27,841 Total liabilities 49,276 648 49,924 Total liabilities and stockholders' equity 88,277 (531 ) 87,746 Statement of Operations: Total revenue $ 63,554 $ (5,405 ) $ 58,149 Total cost of revenue 31,065 (4,226 ) 26,839 Gross profit 32,489 (1,179 ) 31,310 Operating loss (4,101 ) (1,179 ) (5,280 ) Net loss (6,515 ) (1,179 ) (7,694 ) Net loss per share $ (0.04 ) $ (0.05 ) 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 In May 2017, the FASB issued ASU No. 2017-09, Compensation – Stock Compensation (Topic 718): Scope of Modification 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 Recent Accounting Pronouncements Not Yet Adopted as December 31, 2018 In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments |
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 USD and are subject to foreign currency exchange rate fluctuations. Foreign currency transaction gains and losses are included in other income (expense) 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 From time to time, the Company has invested in U.S. Treasury bills and government agency notes that are classified as held-to-maturity because of the Company’s 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, 2018. |
Accounts Receivable | Accounts Receivable Trade accounts receivable represents amounts billed to customers and 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 and changes in customer payment terms. At December 31, 2018, the Company’s trade accounts receivable balance was due primarily from Teva, AMAG and distributors. Each of these customers has historically paid timely and demonstrated creditworthiness. Accordingly, the Company believes the risk of accounts being uncollectible is minimal, and had no significant allowances for doubtful accounts established as of December 31, 2018 or 2017. If the financial condition of the Company’s customers were to deteriorate, adversely affecting their ability to make payments, additional allowances may be required. The Company had no bad debt expense in 2018, 2017 or 2016. Royalties receivable from partners are included in accounts receivable and are typically payable to the Company within 45 to 60 days after the end of each quarter and or annual period in which they were earned. |
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, 2018 2017 Raw material $ 26 $ 118 Work in process 7,622 6,223 Finished goods 3,702 2,934 $ 11,350 $ 9,275 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 $847 and $510 at December 31, 2018 and 2017, respectively. In 2018, the Company wrote off inventory of $255 and increased the reserve for excess, dated or obsolete inventory by $592. In 2017, the Company wrote off $746 of inventory and increased the reserve for excess, dated or obsolete inventory by $356. |
Contract Assets | Contract Assets Contract assets are recognized when control of goods or services has transferred to the customer, and corresponding revenue is recognized on an over time basis, but is not yet billable to the customer in accordance with the terms of the contract. Costs that have been incurred but not yet billed in connection with development services provided to partners are also recorded as contract assets. As of December 31, 2018, contract assets also include a $5,000 installment to be received in connection with the sale and transfer of assets to Ferring as discussed in Note 3. |
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, 2018 2017 Furniture, fixtures and office equipment $ 2,331 $ 2,258 Production molds and equipment 19,678 15,322 Molds and tooling in process 456 4,023 Less accumulated depreciation (7,570 ) (5,445 ) $ 14,895 $ 16,158 Depreciation expense was $2,125, $1,536 and $1,326 for the years ended December 31, 2018, 2017 and 2016, respectively. In 2017, the Company sold certain assets, including molds and equipment, to Ferring, the net book value of which was $933. |
Intangible assets | Intangible assets The Company capitalizes external legal costs and filing fees associated with obtaining patent rights for approved commercial and partnered products when there are projected future cash flows associated with the patent. These capitalized patent costs are 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 ranges 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 $3,794 and $2,963, respectively at December 31, 2018, and $3,772 and $2,371, respectively, at December 31, 2017. Patent amortization expense for the years ended December 31, 2018, 2017 and 2016 was $599, $568 and $534, 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 $353, $127, $89, $82 and $68 in 2019, 2020, 2021, 2022 and 2023, respectively. In 2017, the Company sold certain assets, including patent rights, to Ferring. The net book value of the patents sold was $108. |
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, 2018 and 2017, 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, 2018, 2017, and 2016, respectively. |
Revenue Recognition | Revenue Recognition The Company generates revenue from proprietary and partnered product sales, license and development activities and royalty arrangements. Revenue is recognized when or as the Company transfers control of the promised goods or services to its customers at the transaction price, which is the amount that reflects the consideration to which it expects to be entitled to in exchange for those goods or services. At inception of each contract, the Company identifies the goods and services that have been promised to the customer and each of those that represent a distinct performance obligation, determines the transaction price including any variable consideration, allocates the transaction price to the distinct performance obligations and determines whether control transfers to the customer at a point in time or over time. Variable consideration is included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company reassess its reserves for variable consideration at each reporting date and makes adjustments, if necessary, The Company has elected to recognize the cost for freight and shipping activities as fulfilment cost. Amounts billed to customers for shipping and handling are included as part of the transaction price and recognized as revenue when control of underlying goods are transferred to the customer. The related shipping and freight charges incurred by the Company are included in cost of revenue. Proprietary Product Sales The Company sells its proprietary products OTREXUP ® TM The determination of certain of these reserves and sales allowances require management to make a number of judgements and estimates to reflect the Company’s best estimate of the transaction price and the amount of consideration to which it believes it is ultimately entitled to receive. The expected value is determined based on unit sales data, contractual terms with customers and third-party payers, historical and expected utilization rates, any new or anticipated changes in programs or regulations that would impact the amount of the actual rebates, customer purchasing patterns, product expiration dates and levels of inventory in the distribution channel. Reserves for prompt payment discounts are recorded as a reduction in accounts receivable. Reserves for returns, distributor fees, rebates and customer co-pay support programs are included within current liabilities in our consolidated balance sheets. Wholesaler Distribution Fees . Distribution fees are paid to certain wholesalers based on contractually determined rates and units purchased. S ince the fee paid to the customer is not for a distinct good or service, the consideration is recognized as a reduction of the transaction price of the goods delivered in accordance with ASC 606. The Company accrues the estimated fee due at the time of sale based on the contracted price and adjusts the accrual at each reporting period, if necessary, to reflect actual experience. Prompt Pay Discounts . The Company offers cash discounts to its customers, generally 2% of the sales price, as an incentive for prompt payment. Based on historical experience, customers take advantage of this discount and accordingly the Company accrues 100% of the cash discounts offered by reducing accounts receivable and recognizing the discount as a reduction of revenue in the same period the related sales are made. The accrual is reviewed at each reporting period and adjusted if actual experience differs from estimates. 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 plan 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 also offers discount cards, co-pay coupons and free trial programs to off-set the cost of prescriptions to patients. The Company estimates the total amount that will be redeemed or utilized based on historical redemption experience and on levels of inventory in the distribution and retail channels and recognizes the discount as a reduction of revenue in the same period the related revenue is recognized. Product Returns. Consistent with industry practice, the Company generally offers wholesalers and specialty distributors a limited right to return products, generally within six months prior to and 12 months following the product’s expiration date. The Company’s propriety products generally have expiration dates ranging from 24 to 33 months. Product returns are estimated and recorded at the time of sale based on historical return patterns. Actual returns are tracked by individual production lots and charged against reserves. Returns reserves may be adjusted, if necessary, if actual returns differ from historical estimates. Management also monitors and takes into consideration the amount of estimated product inventory in the distribution channel, product dating and any known or expected changes in the marketplace when establishing is estimated rate of returns. The Company has limited historical sales and returns experience for its newly launched product XYOSTED TM TM adjustments Prior to the first quarter of 2017, in accordance with ASC 605 and industry practice, recognition of revenue related to proprietary product sales was deferred until rights of return no longer existed, which occurred at the earlier of the time units were dispensed through patient prescriptions or expiration of the right of return of the product, as the Company had limited sales and returns history for proprietary products and could not reliably estimate expected returns in accordance with revenue recognition standards at the time. However, in the first quarter of 2017, the Company determined it had developed sufficient historical information to reasonably estimate potential returns and began recognizing revenue, net of estimated returns, upon delivery to the distributors. As a result, the Company recognized an additional $1,297 for product shipped to distributors in previous periods that had not been previously recognized as revenue at the time of shipment, net of the returns allowance established in the first quarter of 2017. The Company also recognized $254 of related product costs that had been previously deferred. The net impact of these changes resulted in a reduction in net loss of $1,043, which was less than $0.01 per share, for the year ended December 31, 2017. The adoption of ASC 606 on January 1, 2018 had no impact on the amount and timing of revenue recognition and related sales reserves and allowances for OTREXUP ® TM The following presents changes in reserves for product returns and sales allowances: Patient Wholesaler Prompt Rebates and Discount Distribution Payment Chargebacks Programs Returns Fees Discounts Balance at December 31, 2016 $ 1,012 $ 81 $ — $ 391 $ 57 Accruals and adjustments 6,848 1,027 1,128 2,864 570 Payments and other reserve reductions (6,545 ) (993 ) (883 ) (2,790 ) (543 ) Balance at December 31, 2017 1,315 115 245 465 84 Accruals and adjustments 9,586 2,429 1,628 3,519 742 Payments and other reserve reductions (8,207 ) (1,254 ) (720 ) (3,194 ) (610 ) Balance at December 31, 2018 $ 2,694 $ 1,290 $ 1,153 $ 790 $ 216 Partnered Product Sales The Company is party to several license, development, supply and distribution arrangements with pharmaceutical partners, under which the Company produces and is the exclusive supplier of certain products, devices and/or components. Revenue is recognized when or as control of the goods transfers to the customer as follows: The Company is the exclusive supplier of the Makena ® All other partnered product sales are recognized at the point in time in which control is transferred to the customer, which is typically upon shipment. Sales terms and pricing are governed by the respective supply and distribution agreements, and there is generally no price protection or right of return. Revenue is recognized at the transaction price, which includes the contractual per unit selling price and estimated variable consideration, if any. For example, the Company sells Sumatriptan Injection USP to Teva at cost and is 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. The Company recognizes revenue, including the estimated variable consideration it expects to receive for contract margin on future commercial sales, upon shipment of the goods to Teva. The estimated variable consideration is recognized at an amount the Company believes is not subject to significant reversal based on historical experience, and is adjusted at each reporting period if the most likely amount of expected consideration changes or becomes fixed. Licensing and Development Revenue The Company has entered into several license, development and supply arrangements with pharmaceutical partners under which the Company grants a license to its device technology and know-how and provides research and development services that often involve multiple performance obligations and highly customized deliverables. For such arrangements, the Company identifies each of the promised goods and services within the contract and the distinct performance obligations at inception, and allocates consideration to each performance obligation based on relative standalone selling price, which is generally determined based on the expected cost plus margin. If the contract includes an enforceable right to payment for performance completed to date and performance obligations are satisfied over time, the Company recognized revenue over the development period using either the input or output method depending on which is most appropriate given the nature of the distinct deliverable. For other contracts that do not contain an enforceable right to payment for performance completed to date, revenue is recognized when control is transferred to the customer. Factors that may indicate that the transfer of control has occurred include the transfer of legal title, transfer of physical possession, the customer has obtained the significant risks and rewards of ownership of the assets and the Company has a present right to payment. The Company’s typical payment terms for development contracts may include an upfront payment equal to a percentage of the total contract value with the remaining portion to be billed upon completion and transfer of the individual deliverables or satisfaction of the individual performance obligations. The Company records a liability for cash received in advance of performance, which is presented within deferred revenue on the consolidated balance sheet and recognized as revenue when the associated performance obligations have been satisfied. License fees and milestones received in exchange for the grant of a license to the Company’s functional intellectual property (“IP”) such as patented technology and know-how in connection with a partnered development arrangement are generally recognized at inception of the arrangement, or over the development period depending on the facts and circumstances, as the license is not generally distinct from the non-licensed goods or services to be provided under the contract. Milestone payments that are contingent upon the occurrence of future events, are evaluated and recorded at the most likely amount, and to the extent that it is probable that a significant reversal will not occur when the associated uncertainty is resolved. Royalties The Company earns royalties in connection with licenses granted under license and development arrangements with partners. Royalties are based upon a percentage of commercial sales of partnered products with rates ranging from mid single digit to low double digit and are tiered based on levels of net sales. These sales-based royalties, for which the license was deemed the predominant element to which the royalties relate, are estimated and recognized in the period in which the partners’ commercial sales occur. The royalties are generally reported and payable to the Company within 45 to 60 days of the end of the period in which the commercial sales are made. The Company bases its estimates of royalties earned on actual sales information from its partners when available or estimated prescription sales from external sources and estimated net selling price. If actual royalties received are different than amounts estimated, the Company would adjust the royalty revenue in the period in which the adjustment becomes known. Remaining Performance Obligations Remaining performance obligations represents the transaction price of firm orders and development contract deliverables for which work has not been completed or orders fulfilled, and excludes potential purchase orders under ordering-type supply contracts with indefinite delivery or quantity. As of December 31, 2018, the aggregate value of remaining performance obligations, excluding contracts with an original expected length of one year or less, was $5.3 million. The Company expects to recognize revenue on the remaining performance obligations over the next three years, with the majority being recognized in the next twelve months. |
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 statements 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 impact the estimated fair value of the stock option awards. |
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. |
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 annual periods presented. Potentially dilutive securities excluded from dilutive loss per share were 17,147, 14,761 and 13,484 at December 31, 2018, 2017 and 2016, 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. |
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, 2018, the Company had cash and cash equivalents of $27,892. 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 consolidated financial statements were issued. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Summary of Significant Accounting Policies [Line Items] | |
Inventories | Inventory consists of the following: December 31, December 31, 2018 2017 Raw material $ 26 $ 118 Work in process 7,622 6,223 Finished goods 3,702 2,934 $ 11,350 $ 9,275 |
Components of Equipment, Molds, Furniture, and Fixtures | The Company’s equipment, molds, furniture and fixtures consisted of the following: December 31, December 31, 2018 2017 Furniture, fixtures and office equipment $ 2,331 $ 2,258 Production molds and equipment 19,678 15,322 Molds and tooling in process 456 4,023 Less accumulated depreciation (7,570 ) (5,445 ) $ 14,895 $ 16,158 |
Summary of Changes in Reserves for Product Returns and Sales Allowances | The following presents changes in reserves for product returns and sales allowances: Patient Wholesaler Prompt Rebates and Discount Distribution Payment Chargebacks Programs Returns Fees Discounts Balance at December 31, 2016 $ 1,012 $ 81 $ — $ 391 $ 57 Accruals and adjustments 6,848 1,027 1,128 2,864 570 Payments and other reserve reductions (6,545 ) (993 ) (883 ) (2,790 ) (543 ) Balance at December 31, 2017 1,315 115 245 465 84 Accruals and adjustments 9,586 2,429 1,628 3,519 742 Payments and other reserve reductions (8,207 ) (1,254 ) (720 ) (3,194 ) (610 ) Balance at December 31, 2018 $ 2,694 $ 1,290 $ 1,153 $ 790 $ 216 |
Accounting Standards Update 2014-09 [Member] | |
Summary of Significant Accounting Policies [Line Items] | |
Summary of Adoption of New Accounting Standard Impact on Consolidated Financial Statement | The following table presents information about the impact of ASC 606 on the Company’s consolidated financial statement as of and for the year ended December 31, 2018: Effect of Balance / Total Balance / Total Change Without Adoption as Reported Higher/(Lower) of ASC 606 Balance Sheet: Inventories $ 11,350 $ 4,226 $ 15,576 Contract assets 10,442 (4,757 ) 5,685 Total current assets 71,308 (531 ) 70,777 Total assets 88,277 (531 ) 87,746 Accrued expenses and other liabilities 11,997 (1,029 ) 10,968 Deferred revenue 1,018 1,677 2,695 Total current liabilities 27,193 648 27,841 Total liabilities 49,276 648 49,924 Total liabilities and stockholders' equity 88,277 (531 ) 87,746 Statement of Operations: Total revenue $ 63,554 $ (5,405 ) $ 58,149 Total cost of revenue 31,065 (4,226 ) 26,839 Gross profit 32,489 (1,179 ) 31,310 Operating loss (4,101 ) (1,179 ) (5,280 ) Net loss (6,515 ) (1,179 ) (7,694 ) Net loss per share $ (0.04 ) $ (0.05 ) |
Sales of Assets (Tables)
Sales of Assets (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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, 2018 | |
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 contractual End of Term Charge, are as follows: 2019 $ 3,043 2020 7,830 2021 8,624 2022 6,566 $ 26,063 |
Share Based Compensation (Table
Share Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Summary of Stock Option Activity | Stock option activity under the Plan as of and for the three years ended December 31, 2018 is as follows: Weighted Weighted Average Average Remaining Aggregate Number of Exercise Contractual Intrinsic Shares Price ($) Term (Years) Value ($) Outstanding at December 31, 2015 9,480 2.19 Granted/Issued 4,030 1.14 Exercised (142 ) 1.23 122 Cancelled/Forfeited (2,054 ) 2.13 Outstanding at December 31, 2016 11,314 1.84 Granted/Issued 2,986 2.67 Exercised (1,311 ) 1.38 2,226 Cancelled/Forfeited (840 ) 2.68 Outstanding at December 31, 2017 12,149 2.04 Granted/Issued 2,693 2.72 Exercised (477 ) 1.14 768 Cancelled/Forfeited (286 ) 2.43 Outstanding at December 31, 2018 14,079 2.19 6.8 8,534 Exercisable at December 31, 2018 10,556 2.07 6.1 7,834 |
Assumptions Used in Fair Value Measurement of Options Granted | December 31, 2018 2017 2016 Risk-free interest rate 2.8 % 1.8 % 1.3 % Annualized volatility 53.7 % 53.3 % 51.7 % 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, 2015 956 2.40 715 2.32 Granted 751 1.15 751 1.12 Vested/settled (17 ) 3.96 (264 ) 2.41 Forfeited/expired (343 ) 2.17 (379 ) 1.91 Outstanding at December 31, 2016 1,347 1.50 823 1.39 Granted 689 3.12 689 2.69 Vested/settled — (288 ) 1.49 Forfeited/expired (581 ) 2.16 (67 ) 1.70 Outstanding at December 31, 2017 1,455 2.20 1,157 2.12 Granted 611 2.89 611 2.70 Vested/settled (173 ) 2.18 (500 ) 1.99 Forfeited/expired (51 ) 3.01 (42 ) 2.68 Outstanding at December 31, 2018 1,842 2.41 1,226 2.44 |
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: 2018 Award 2017 Award 2016 Award Closing stock price on grant date $ 2.70 $ 2.66 $ 1.12 Performance period starting price $ 1.92 $ 2.17 $ 1.29 Term of award (in years) 2.57 2.57 2.58 Volatility 64.9 % 54.6 % 70.1 % Risk-free interest rate 2.56 % 1.39 % 0.97 % Expected dividend yield 0.00 % 0.00 % 0.00 % Fair value per TSR PSU $ 3.27 $ 3.10 $ 1.25 |
Accrued Expenses and Other Li_2
Accrued Expenses and Other Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consisted of the following: December 31, December 31, 2018 2017 Accrued employee compensation and benefits $ 3,715 $ 2,470 Product returns and sales allowances 5,927 2,140 Other liabilities 2,355 2,372 $ 11,997 $ 6,982 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Leases [Abstract] | |
Summary of Future Minimum Lease Payments | Future minimum lease payments under operating leases as of December 31, 2018 were as follows: Amount 2019 $ 566 2020 233 2021 238 2022 60 2023 — Thereafter — Total future minimum lease payments $ 1,097 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
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: 2018 2017 2016 U.S. $ (6,696 ) $ (16,762 ) $ (24,229 ) Switzerland 181 19 (10 ) $ (6,515 ) $ (16,743 ) $ (24,239 ) |
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, 2018, 2017 and 2016 as follows: 2018 2017 2016 Statutory income tax rate (21.0 )% (34.0 )% (34.0 )% State income taxes (3.8 ) (6.1 ) (6.8 ) Valuation allowance increase 20.8 (102.0 ) 35.9 Effect of foreign operations (0.2 ) — — Change in unused net operating loss and credit carryforwards (3.9 ) 2.7 3.7 162(m) limitation 2.9 — — Nondeductible items 3.2 (5.1 ) 1.6 Impact of Tax Cuts and Jobs Act 2.0 144.5 — 0.0 % 0.0 % 0.4 % |
Summary of Deferred Tax Assets (Liabilities) | Deferred tax assets (liabilities) as of December 31, 2018 and 2017 consist of the following: 2018 2017 Gross deferred tax assets: Net operating loss carryforward – U.S. $ 42,966 $ 43,046 Net operating loss carryforward – Switzerland 7 67 Research and development tax credit carryforward 6,891 6,153 Deferred revenue 105 339 Stock-based compensation 2,324 1,882 Inventory reserve 440 140 Compensation accruals 904 662 163j interest expense limitation 438 — Amortization 562 429 Other 1,631 575 Total deferred tax assets 56,268 53,293 Deferred tax liabilities: Depreciation (1,511 ) (1,255 ) Installment obligations (1,363 ) — Total deferred tax liabilities (2,874 ) (1,255 ) Net deferred tax asset before valuation allowance 53,394 52,038 Less valuation allowance (53,394 ) (52,038 ) Net deferred tax asset $ — $ — |
Revenues, Significant Custome_2
Revenues, Significant Customers and Concentrations of Risk (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Revenue From Contract With Customer [Abstract] | |
Summary of Revenues Disaggregated by Major Types and Sources and Customer Geographic Location | The following table presents the Company’s revenue on a disaggregated basis by major types and sources: For the Years Ended December 31, 2018 2017 2016 Proprietary product sales $ 17,532 $ 17,946 $ 15,145 Partnered product sales 30,338 23,749 25,173 Total product sales 47,870 41,695 40,318 Licensing and development revenue 6,753 11,171 10,401 Royalties 8,931 1,649 1,503 Total revenue $ 63,554 $ 54,515 $ 52,222 Revenues disaggregated by customer geographic location are summarized as follows: For the Years Ended December 31, 2018 2017 2016 United States of America $ 57,033 $ 48,924 $ 45,531 Europe 6,157 5,061 6,117 Other 364 530 574 $ 63,554 $ 54,515 $ 52,222 |
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, 2018 2017 2016 Teva $ 19,756 $ 20,949 $ 24,941 AMAG 18,121 8,965 4,446 McKesson (1) 7,338 8,707 7,600 AmerisourceBergen (1) 6,952 6,098 4,903 Ferring 7,023 5,258 6,283 (1) Revenue from sales to distributors, net of estimated sales returns and allowances based on shipments. |
Quarterly Financial Data (una_2
Quarterly Financial Data (unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Data | First Second Third Fourth 2018 Total revenues $ 12,703 $ 14,162 $ 17,868 $ 18,821 Gross profit 5,517 7,202 10,579 9,191 Net income (loss) (6,193 ) (4,520 ) (1,936 ) 6,134 Net income (loss) per common share, basic and diluted (1) (0.04 ) (0.03 ) (0.01 ) 0.04 Weighted average shares (1) 156,724 157,024 157,471 158,389 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, basic and diluted (0.03 ) (0.02 ) (0.03 ) (0.02 ) Weighted average shares 155,215 155,926 156,401 156,655 (1) Net income (loss) per common share is computed based upon the net income or loss divided by the weighted average number of shares outstanding during each period. Basic and diluted income (loss) per share amounts were identical for the first, second and third quarters, respectively, as the effect of potential common shares were anti-dilutive. Weighted average shares on a fully diluted basis, taking into consideration the effects of dilutive stock options, restricted stock and performance stock awards, was 162,810 for the fourth quarter of 2018, which resulted in the income per share being the same on both a basic and diluted basis. |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2017USD ($) | Dec. 31, 2018USD ($)Subsidiaryshares | Dec. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2016USD ($)shares | |
Summary of Significant Accounting Policies [Line Items] | ||||
Wholly-owned subsidiaries of Antares Pharma | Subsidiary | 2 | |||
Selling, general and administrative | $ 36,762,000 | $ 31,646,000 | $ 27,930,000 | |
Research and development expenses | 12,328,000 | 11,854,000 | 19,592,000 | |
Operating loss | (4,101,000) | (15,591,000) | (24,117,000) | |
Total other expense | (2,414,000) | (1,152,000) | (122,000) | |
Carrying value of short-term investments | 0 | 4,993,000 | ||
Bad debt expense | 0 | 0 | 0 | |
Allowance for doubtful accounts balance | 0 | 0 | ||
Inventory reserve | 847,000 | 510,000 | ||
Inventory written-off | 255,000 | 746,000 | ||
Increase in inventory reserve | 592,000 | 356,000 | 748,000 | |
Installment to be received in connection with the sale and transfer | 5,000,000 | |||
Depreciation expense | 2,125,000 | 1,536,000 | 1,326,000 | |
Patent rights | 3,794,000 | 3,772,000 | ||
Accumulated amortization of patents | 2,963,000 | 2,371,000 | ||
Aggregate patent amortization expense, 2018 | 353,000 | |||
Aggregate patent amortization expense, 2019 | 127,000 | |||
Aggregate patent amortization expense, 2020 | 89,000 | |||
Aggregate patent amortization expense, 2021 | 82,000 | |||
Aggregate patent amortization expense, 2022 | 68,000 | |||
Amortization expense | 599,000 | 568,000 | 534,000 | |
Net book value of patents sold | 108,000 | |||
Goodwill | 1,095,000 | 1,095,000 | ||
Goodwill impairment loss | $ 0 | $ 0 | $ 0 | |
Cash discount to incentive for prompt payment | 2.00% | |||
Remaining performance obligations | $ 5,300,000 | |||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Explanation | The Company expects to recognize revenue on the remaining performance obligations over the next three years, with the majority being recognized in the next twelve months | |||
Method used for fair value assumption | Black-Scholes option valuation model | |||
Potentially dilutive securities excluded from dilutive loss per share | shares | 17,147,000 | 14,761,000 | 13,484,000 | |
Cash and cash equivalents | $ 27,892,000 | $ 26,562,000 | ||
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 | |||
Royalty payment period | 45 days | |||
Maximum [Member] | ||||
Summary of Significant Accounting Policies [Line Items] | ||||
Estimated useful lives | 10 years | |||
Capitalized cost being amortized over periods | 15 years | |||
Royalty payment period | 60 days | |||
Maximum [Member] | OTREXUP [Member] | ||||
Summary of Significant Accounting Policies [Line Items] | ||||
Revenue Recognition, reduction in net loss per share | $ / shares | $ 0.01 | |||
ASU 2016-02 [Member] | ||||
Summary of Significant Accounting Policies [Line Items] | ||||
Right-of-use asset obtained in exchange for operating lease liability | $ 1,000,000 | |||
Restatement Adjustment [Member] | ||||
Summary of Significant Accounting Policies [Line Items] | ||||
Selling, general and administrative | $ 1,293,000 | $ 1,535,000 | ||
Research and development expenses | (1,293,000) | $ (1,535,000) | ||
Operating loss | (860,000) | |||
Total other expense | $ 860,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary Adoption of New Accounting Standard Impact on Consolidated Financial Statement (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Balance Sheet: | |||||||||||
Inventories | $ 11,350 | $ 9,275 | $ 11,350 | $ 9,275 | |||||||
Contract assets | 10,442 | 505 | 10,442 | 505 | |||||||
Total current assets | 71,308 | 55,536 | 71,308 | 55,536 | |||||||
Total assets | 88,277 | 74,338 | 88,277 | 74,338 | |||||||
Accrued expenses and other liabilities | 11,997 | 6,982 | 11,997 | 6,982 | |||||||
Total current liabilities | 27,193 | 15,733 | 27,193 | 15,733 | |||||||
Total liabilities | 49,276 | 40,791 | 49,276 | 40,791 | |||||||
Total liabilities and stockholders' equity | 88,277 | 74,338 | 88,277 | 74,338 | |||||||
Statement of Operations: | |||||||||||
Total revenue | 18,821 | $ 17,868 | $ 14,162 | $ 12,703 | 14,040 | $ 15,052 | $ 13,416 | $ 12,007 | 63,554 | 54,515 | $ 52,222 |
Gross profit | 9,191 | 10,579 | 7,202 | 5,517 | 6,932 | 6,529 | 7,800 | 5,788 | 32,489 | 27,049 | 23,405 |
Operating loss | (4,101) | (15,591) | (24,117) | ||||||||
Net loss | 6,134 | $ (1,936) | $ (4,520) | $ (6,193) | $ (3,714) | $ (5,453) | $ (2,840) | $ (4,736) | $ (6,515) | $ (16,743) | $ (24,339) |
Basic and diluted net loss per common share | $ (0.04) | $ (0.11) | $ (0.16) | ||||||||
Accounting Standards Update 2014-09 [Member] | |||||||||||
Balance Sheet: | |||||||||||
Inventories | 11,350 | $ 11,350 | |||||||||
Contract assets | 10,442 | 10,442 | |||||||||
Total current assets | 71,308 | 71,308 | |||||||||
Total assets | 88,277 | 88,277 | |||||||||
Accrued expenses and other liabilities | 11,997 | 11,997 | |||||||||
Deferred revenue | 1,018 | 1,018 | |||||||||
Total current liabilities | 27,193 | 27,193 | |||||||||
Total liabilities | 49,276 | 49,276 | |||||||||
Total liabilities and stockholders' equity | 88,277 | 88,277 | |||||||||
Statement of Operations: | |||||||||||
Total revenue | 63,554 | ||||||||||
Total cost of revenue | 31,065 | ||||||||||
Gross profit | 32,489 | ||||||||||
Operating loss | (4,101) | ||||||||||
Net loss | $ (6,515) | ||||||||||
Basic and diluted net loss per common share | $ (0.04) | ||||||||||
Accounting Standards Update 2014-09 [Member] | Effect of Change Higher/(Lower) [Member] | |||||||||||
Balance Sheet: | |||||||||||
Inventories | 4,226 | $ 4,226 | |||||||||
Contract assets | (4,757) | (4,757) | |||||||||
Total current assets | (531) | (531) | |||||||||
Total assets | (531) | (531) | |||||||||
Accrued expenses and other liabilities | (1,029) | (1,029) | |||||||||
Deferred revenue | 1,677 | 1,677 | |||||||||
Total current liabilities | 648 | 648 | |||||||||
Total liabilities | 648 | 648 | |||||||||
Total liabilities and stockholders' equity | (531) | (531) | |||||||||
Statement of Operations: | |||||||||||
Total revenue | (5,405) | ||||||||||
Total cost of revenue | (4,226) | ||||||||||
Gross profit | (1,179) | ||||||||||
Operating loss | (1,179) | ||||||||||
Net loss | (1,179) | ||||||||||
Accounting Standards Update 2014-09 [Member] | Balance / Total Without Adoptionof ASC 606 [Member] | |||||||||||
Balance Sheet: | |||||||||||
Inventories | 15,576 | 15,576 | |||||||||
Contract assets | 5,685 | 5,685 | |||||||||
Total current assets | 70,777 | 70,777 | |||||||||
Total assets | 87,746 | 87,746 | |||||||||
Accrued expenses and other liabilities | 10,968 | 10,968 | |||||||||
Deferred revenue | 2,695 | 2,695 | |||||||||
Total current liabilities | 27,841 | 27,841 | |||||||||
Total liabilities | 49,924 | 49,924 | |||||||||
Total liabilities and stockholders' equity | $ 87,746 | 87,746 | |||||||||
Statement of Operations: | |||||||||||
Total revenue | 58,149 | ||||||||||
Total cost of revenue | 26,839 | ||||||||||
Gross profit | 31,310 | ||||||||||
Operating loss | (5,280) | ||||||||||
Net loss | $ (7,694) | ||||||||||
Basic and diluted net loss per common share | $ (0.05) |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Inventories (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Inventory Disclosure [Abstract] | ||
Raw material | $ 26 | $ 118 |
Work in process | 7,622 | 6,223 |
Finished goods | 3,702 | 2,934 |
Inventory, Total | $ 11,350 | $ 9,275 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Components of Equipment, Molds, Furniture, and Fixtures (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Property Plant And Equipment [Abstract] | ||
Furniture, fixtures and office equipment | $ 2,331 | $ 2,258 |
Production molds and equipment | 19,678 | 15,322 |
Molds and tooling in process | 456 | 4,023 |
Less accumulated depreciation | (7,570) | (5,445) |
Equipment, molds, furniture and fixtures, Total | $ 14,895 | $ 16,158 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Summary of Changes in Reserves for Product Returns and Sales Allowances (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Accounts Notes And Loans Receivable [Line Items] | |||
Payments and other reserve reductions | $ 0 | $ 0 | $ 0 |
Rebates and Chargebacks [Member] | |||
Accounts Notes And Loans Receivable [Line Items] | |||
Balance at beginning of year | 1,315,000 | 1,012,000 | |
Accruals and adjustments | 9,586,000 | 6,848,000 | |
Payments and other reserve reductions | (8,207,000) | (6,545,000) | |
Balance at end of year | 2,694,000 | 1,315,000 | 1,012,000 |
Patient Discount Programs [Member] | |||
Accounts Notes And Loans Receivable [Line Items] | |||
Balance at beginning of year | 115,000 | 81,000 | |
Accruals and adjustments | 2,429,000 | 1,027,000 | |
Payments and other reserve reductions | (1,254,000) | (993,000) | |
Balance at end of year | 1,290,000 | 115,000 | 81,000 |
Returns [Member] | |||
Accounts Notes And Loans Receivable [Line Items] | |||
Balance at beginning of year | 245,000 | ||
Accruals and adjustments | 1,628,000 | 1,128,000 | |
Payments and other reserve reductions | (720,000) | (883,000) | |
Balance at end of year | 1,153,000 | 245,000 | |
Wholesaler Distribution Fees [Member] | |||
Accounts Notes And Loans Receivable [Line Items] | |||
Balance at beginning of year | 465,000 | 391,000 | |
Accruals and adjustments | 3,519,000 | 2,864,000 | |
Payments and other reserve reductions | (3,194,000) | (2,790,000) | |
Balance at end of year | 790,000 | 465,000 | 391,000 |
Prompt Payment Discounts [Member] | |||
Accounts Notes And Loans Receivable [Line Items] | |||
Balance at beginning of year | 84,000 | 57,000 | |
Accruals and adjustments | 742,000 | 570,000 | |
Payments and other reserve reductions | (610,000) | (543,000) | |
Balance at end of year | $ 216,000 | $ 84,000 | $ 57,000 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Additional Information (Detail1) | Dec. 31, 2018 |
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date: 2019-01-01 | |
Summary of Significant Accounting Policies [Line Items] | |
Remaining performance obligation, expected to recognize, period | 3 years |
Sale of Assets - Additional Inf
Sale of Assets - Additional Information (Detail) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Oct. 31, 2017USD ($)Installment | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | |
Sale of Assets [Line Items] | |||
Receipt of second and third installments | $ 7,500 | $ 1,901 | |
Gain on sale of assets | 12,500 | 860 | |
Contract assets | $ 10,442 | 505 | |
Asset Purchase Agreement [Member] | Ferring [Member] | |||
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 was 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; 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”). | ||
Upfront payment received upon transfer of assets | $ 2,000 | ||
Consideration receivable on criteria completion related to product manufacturing | 2,750 | ||
Consideration receivable on criteria completion related to Audit and pilot manufacturing | 4,750 | ||
Consideration receivable on criteria completion related to Product commercialization | $ 5,000 | ||
Receipt of second and third installments | $ 7,500 | ||
Gain on sale of assets | $ 860 | ||
Contract assets | 5,000 | ||
Asset Purchase Agreement [Member] | Ferring [Member] | ASC 610-20 [Member] | |||
Sale of Assets [Line Items] | |||
Gain on sale of assets | $ 12,500 |
Sale of Assets - Schedule of Ga
Sale of Assets - Schedule of Gain on Sale of Assets (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Sale of Assets [Line Items] | ||
Net book value of patents transferred | $ 108 | |
Gain on sale of assets | $ 12,500 | 860 |
Asset Purchase Agreement [Member] | Ferring [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 ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Jun. 30, 2017 | |
Debt Instrument [Line Items] | |||
Carrying value of long term debt | $ 22,083,000 | $ 24,858,000 | |
Hercules Capital, Inc [Member] | Term Loan [Member] | |||
Debt Instrument [Line Items] | |||
Long-tem debt, face amount | $ 25,000,000 | ||
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, payment terms | Payments under the Loan Agreement are interest only until the first principal payment is due on August 1, 2019. | ||
Debt instrument, first pricipal payment due date | Aug. 1, 2019 | ||
Percentage of loan fee on original principal amount | 4.25% | ||
Carrying value of long term debt | $ 25,126,000 | 24,858,000 | |
Principal balance outstanding | 25,000,000 | ||
Interest payments | $ 2,353,000 | $ 1,080,000 | |
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] | Prime Based Variable Rate [Member] | |||
Debt Instrument [Line Items] | |||
Debt Instrument, variable interest rate | 9.50% |
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, 2018USD ($) |
Debt Disclosure [Abstract] | |
2019 | $ 3,043 |
2020 | 7,830 |
2021 | 8,624 |
2022 | 6,566 |
Long-term debt | $ 26,063 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | |
Aug. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | |
Stockholders Equity [Line Items] | |||
Aggregate offering price of common stock | $ 7,114,000 | ||
Proceeds from sale of common stock | $ 7,114,000 | ||
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% | ||
Sales Agreement [Member] | Cowen and Company, LLC [Member] | Maximum [Member] | |||
Stockholders Equity [Line Items] | |||
Aggregate offering price of common stock | $ 30,000,000 | ||
Offering and Sales Agreement [Member] | |||
Stockholders Equity [Line Items] | |||
Issuance of common stock, shares | 2,137,000 | ||
Gross proceeds from sale of common stock | $ 7,555,000 | ||
Proceeds from sale of common stock | $ 7,114,000 | $ 0 |
Share Based Compensation - Addi
Share Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Proceeds from the issuance of stock options | $ 474 | $ 1,816 | $ 101 | |
Shares withheld to meet employees' minimum statutory income tax obligation | 211,000 | 98,000 | 74,000 | |
Payments for the employees' minimum statutory income tax obligation | $ 543 | $ 249 | $ 84 | |
Employees Tax Obligations [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Payments for the employees' minimum statutory income tax obligation | $ 543 | $ 249 | $ 84 | |
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 | 2,960,000 | |||
Stock Options [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Per share weighted average fair value of options granted | $ 1.45 | $ 1.37 | $ 0.57 | |
Proceeds from the issuance of stock options | $ 474 | $ 1,816 | $ 101 | |
Exercise of options, shares | 447,000 | 1,311,000 | 103,000 | |
Shares withheld to meet employees' minimum statutory income tax obligation | 30,000 | 40,000 | ||
Recognized compensation cost related to shares of stock granted | $ 2,956 | $ 2,378 | $ 2,039 | |
Unrecognized compensation cost related to nonvested outstanding stock awards | $ 4,440 | |||
Weighted average period expected to be recognized | 1 year 9 months 18 days | |||
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 | |||
Stock Options [Member] | 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 | |||
Restricted Stock Units [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of shares granted in 2016 | 611,000 | 689,000 | 751,000 | |
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 | $ 1,173 | $ 701 | $ 413 | |
Performance Stock Units [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of shares granted in 2016 | 611,000 | 689,000 | 751,000 | |
Performance 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 | $ 798 | $ 411 | $ 68 | |
Number of shares granted in 2016 | 593,000 | |||
Performance Stock Units [Member] | Long Term Incentive Program [Member] | Scenario, Forecast [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of shares approved for settlement | 415,000 | |||
Performance Stock Units [Member] | Minimum [Member] | Long Term Incentive Program [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
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] | ||||
Share based compensation award percentage | 150.00% |
Share Based Compensation - Summ
Share Based Compensation - Summary of Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Stockholders Equity Note [Abstract] | |||
Number of Shares Outstanding, Beginning Balance | 12,149,000 | 11,314,000 | 9,480,000 |
Number of Shares Granted/Issued | 2,693,000 | 2,986,000 | 4,030,000 |
Number of Shares Exercised | (477,000) | (1,311,000) | (142,000) |
Number of Shares Cancelled/Forfeited | (286,000) | (840,000) | (2,054,000) |
Number of Shares Outstanding, Ending Balance | 14,079,000 | 12,149,000 | 11,314,000 |
Number of Shares Exercisable, Ending Balance | 10,556,000 | ||
Weighted Average Exercise Price Outstanding, Beginning Balance | $ 2.04 | $ 1.84 | $ 2.19 |
Weighted Average Exercise Price Granted/Issued | 2.72 | 2.67 | 1.14 |
Weighted Average Exercise Price Exercised | 1.14 | 1.38 | 1.23 |
Weighted Average Exercise Price Cancelled/Forfeited | 2.43 | 2.68 | 2.13 |
Weighted Average Exercise Price Outstanding, Ending Balance | 2.19 | $ 2.04 | $ 1.84 |
Weighted Average Exercise Price Exercisable, Ending Balance | $ 2.07 | ||
Weighted Average Remaining Contractual Term (Years) Outstanding, Ending Balance | 6 years 9 months 18 days | ||
Weighted Average Remaining Contractual Term (Years) Exercisable, Ending Balance | 6 years 1 month 6 days | ||
Aggregate Intrinsic Value, Exercised | $ 768 | $ 2,226 | $ 122 |
Aggregate Intrinsic Value Outstanding, Ending Balance | 8,534 | ||
Aggregate Intrinsic Value Exercisable, Ending Balance | $ 7,834 |
Share Based Compensation - Assu
Share Based Compensation - Assumptions Used in Fair Value Measurement of Options Granted (Detail) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Stockholders Equity Note [Abstract] | |||
Risk-free interest rate | 2.80% | 1.80% | 1.30% |
Annualized volatility | 53.70% | 53.30% | 51.70% |
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, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Performance Stock Units [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of Shares, Beginning Balance | 1,455,000 | 1,347,000 | 956,000 |
Number of Shares, Granted | 611,000 | 689,000 | 751,000 |
Number of Shares, Vested/settled | (173,000) | (17,000) | |
Number of Shares, Forfeited/expired | (51,000) | (581,000) | (343,000) |
Number of Shares, Ending Balance | 1,842,000 | 1,455,000 | 1,347,000 |
Weighted Average Grant Date Fair Value, Beginning Balance | $ 2.20 | $ 1.50 | $ 2.40 |
Weighted Average Grant Date Fair Value, Granted | 2.89 | 3.12 | 1.15 |
Weighted Average Grant Date Fair Value, Vested/settled | 2.18 | 3.96 | |
Weighted Average Grant Date Fair Value, Forfeited/expired | 3.01 | 2.16 | 2.17 |
Weighted Average Grant Date Fair Value, Ending Balance | $ 2.41 | $ 2.20 | $ 1.50 |
Restricted Stock Units [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of Shares, Beginning Balance | 1,157,000 | 823,000 | 715,000 |
Number of Shares, Granted | 611,000 | 689,000 | 751,000 |
Number of Shares, Vested/settled | (500,000) | (288,000) | (264,000) |
Number of Shares, Forfeited/expired | (42,000) | (67,000) | (379,000) |
Number of Shares, Ending Balance | 1,226,000 | 1,157,000 | 823,000 |
Weighted Average Grant Date Fair Value, Beginning Balance | $ 2.12 | $ 1.39 | $ 2.32 |
Weighted Average Grant Date Fair Value, Granted | 2.70 | 2.69 | 1.12 |
Weighted Average Grant Date Fair Value, Vested/settled | 1.99 | 1.49 | 2.41 |
Weighted Average Grant Date Fair Value, Forfeited/expired | 2.68 | 1.70 | 1.91 |
Weighted Average Grant Date Fair Value, Ending Balance | $ 2.44 | $ 2.12 | $ 1.39 |
Share Based Compensation - Fair
Share Based Compensation - Fair Value of PSUs Granted Determined Using Monte Carlo Simulation (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Term of award (in years) | 6 years | 6 years | 6 years |
Volatility | 53.70% | 53.30% | 51.70% |
Risk-free interest rate | 2.80% | 1.80% | 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 | $ 2.70 | $ 2.66 | $ 1.12 |
Performance period starting price | $ 1.92 | $ 2.17 | $ 1.29 |
Term of award (in years) | 2 years 6 months 25 days | 2 years 6 months 25 days | 2 years 6 months 29 days |
Volatility | 64.90% | 54.60% | 70.10% |
Risk-free interest rate | 2.56% | 1.39% | 0.97% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Fair value per TSR PSU | $ 3.27 | $ 3.10 | $ 1.25 |
Accrued Expenses and Other Li_3
Accrued Expenses and Other Liabilities - Schedule of Accrued Expenses and Other Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Payables And Accruals [Abstract] | ||
Accrued employee compensation and benefits | $ 3,715 | $ 2,470 |
Product returns and sales allowances | 5,927 | 2,140 |
Other liabilities | 2,355 | 2,372 |
Accrued expenses and other liabilities | $ 11,997 | $ 6,982 |
Employee 401(k) Savings Plan -
Employee 401(k) Savings Plan - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Postemployment Benefits [Abstract] | |||
Defined Contribution Plan, Plan Name | 401(k) | ||
Company plan contributions | $ 814 | $ 590 | $ 519 |
Leases - Additional Information
Leases - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Leases [Abstract] | |||
Rent expense | $ 695 | $ 656 | $ 680 |
Leases - Summary of Future Mini
Leases - Summary of Future Minimum Lease Payments (Detail) $ in Thousands | Dec. 31, 2018USD ($) |
Operating Leases Future Minimum Payments Due [Abstract] | |
2019 | $ 566 |
2020 | 233 |
2021 | 238 |
2022 | 60 |
Total future minimum lease payments | $ 1,097 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Operating Loss Carryforwards [Line Items] | |||
U.S. federal statutory tax rate | 21.00% | 34.00% | 34.00% |
Provisional estimate of reduction in deferred tax assets | $ 113,000 | $ 24,196,000 | |
Provisional estimate of reduction in valuation allowance | $ 113,000 | 24,196,000 | |
Period of incurred losses for both book and tax purposes | 3 years | ||
Valuation allowance for deferred tax assets | $ 53,394,000 | 52,038,000 | |
Increased and decreased total valuation allowance | 1,356,000 | (15,720,000) | |
Deferred tax assets, net of valuation allowances | 0 | 0 | |
Net operating loss carry forward unused amount | 48,000 | ||
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 | $ 171,043,000 | ||
Research credit carryforward | 6,276,000 | ||
Foreign Tax Authority [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carry forward | $ 48,000 | ||
Tax credit carryforward expiration year | 2023 | ||
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 | 2037 | ||
Tax credit carryforward expiration year | 2038 | ||
Minimum [Member] | U.S Federal Tax [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforward expiration year | 2019 | ||
Tax credit carryforward expiration year | 2019 |
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, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income (Loss) from Continuing Operations before Equity Method Investments, Income Taxes, Extraordinary Items, Noncontrolling Interest [Abstract] | |||
Income (loss) before income taxes, US | $ (6,696) | $ (16,762) | $ (24,229) |
Income (loss) before income taxes, Switzerland | 181 | 19 | (10) |
Net loss before income taxes | $ (6,515) | $ (16,743) | $ (24,239) |
Income Taxes - Summary of Effec
Income Taxes - Summary of Effective Tax Rates Differ from Statutory Income Tax Rates (Detail) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Effective Income Tax Rate Reconciliation, Percent [Abstract] | |||
Statutory income tax rate | (21.00%) | (34.00%) | (34.00%) |
State income taxes | (3.80%) | (6.10%) | (6.80%) |
Valuation allowance increase | 20.80% | (102.00%) | 35.90% |
Effect of foreign operations | (0.20%) | ||
Change in unused net operating loss and credit carryforwards | (3.90%) | 2.70% | 3.70% |
162(m) limitation | 2.90% | ||
Nondeductible items | 3.20% | (5.10%) | 1.60% |
Impact of Tax Cuts and Jobs Act | 2.00% | 144.50% | |
Effective income tax rate, Total | (0.00%) | (0.00%) | 0.40% |
Income Taxes - Summary of Defer
Income Taxes - Summary of Deferred Tax Assets (Liabilities) (Detail) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Gross deferred tax assets: | ||
Net operating loss carryforward – U.S. | $ 42,966 | $ 43,046 |
Net operating loss carryforward – Switzerland | 7 | 67 |
Research and development tax credit carryforward | 6,891 | 6,153 |
Deferred revenue | 105 | 339 |
Stock-based compensation | 2,324 | 1,882 |
Inventory reserve | 440 | 140 |
Compensation accruals | 904 | 662 |
163j interest expense limitation | 438 | |
Amortization | 562 | 429 |
Other | 1,631 | 575 |
Total deferred tax assets | 56,268 | 53,293 |
Deferred tax liabilities: | ||
Depreciation | (1,511) | (1,255) |
Installment obligations | (1,363) | |
Total deferred tax liabilities | (2,874) | (1,255) |
Net deferred tax asset before valuation allowance | 53,394 | 52,038 |
Less valuation allowance | $ (53,394) | $ (52,038) |
Revenues, Significant Custome_3
Revenues, Significant Customers and Concentrations of Risk - Summary of Revenue Disaggregated by Major Types and Sources (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | $ 18,821 | $ 17,868 | $ 14,162 | $ 12,703 | $ 14,040 | $ 15,052 | $ 13,416 | $ 12,007 | $ 63,554 | $ 54,515 | $ 52,222 |
Total Product Sales [Member] | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 47,870 | 41,695 | 40,318 | ||||||||
Total Product Sales [Member] | Proprietary Product [Member] | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 17,532 | 17,946 | 15,145 | ||||||||
Total Product Sales [Member] | Partnered Product [Member] | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 30,338 | 23,749 | 25,173 | ||||||||
Licensing and Development Revenue [Member] | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | 6,753 | 11,171 | 10,401 | ||||||||
Royalties [Member] | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenue | $ 8,931 | $ 1,649 | $ 1,503 |
Revenues, Significant Custome_4
Revenues, Significant Customers and Concentrations of Risk - Summary of Disaggregated Revenues by Customer Geographic Location (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenues | $ 18,821 | $ 17,868 | $ 14,162 | $ 12,703 | $ 14,040 | $ 15,052 | $ 13,416 | $ 12,007 | $ 63,554 | $ 54,515 | $ 52,222 |
United States of America [Member] | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenues | 57,033 | 48,924 | 45,531 | ||||||||
Europe [Member] | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenues | 6,157 | 5,061 | 6,117 | ||||||||
Other [Member] | |||||||||||
Disaggregation Of Revenue [Line Items] | |||||||||||
Total revenues | $ 364 | $ 530 | $ 574 |
Revenues, Significant Custome_5
Revenues, 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, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | ||
Concentration Risk [Line Items] | ||||||||||||
Total revenues | $ 18,821 | $ 17,868 | $ 14,162 | $ 12,703 | $ 14,040 | $ 15,052 | $ 13,416 | $ 12,007 | $ 63,554 | $ 54,515 | $ 52,222 | |
Teva [Member] | ||||||||||||
Concentration Risk [Line Items] | ||||||||||||
Total revenues | 19,756 | 20,949 | 24,941 | |||||||||
AMAG [Member] | ||||||||||||
Concentration Risk [Line Items] | ||||||||||||
Total revenues | 18,121 | 8,965 | 4,446 | |||||||||
McKesson [Member] | ||||||||||||
Concentration Risk [Line Items] | ||||||||||||
Total revenues | [1] | 7,338 | 8,707 | 7,600 | ||||||||
AmerisourceBergen [Member] | ||||||||||||
Concentration Risk [Line Items] | ||||||||||||
Total revenues | [1] | 6,952 | 6,098 | 4,903 | ||||||||
Ferring [Member] | ||||||||||||
Concentration Risk [Line Items] | ||||||||||||
Total revenues | $ 7,023 | $ 5,258 | $ 6,283 | |||||||||
[1] | Revenue from sales to distributors, net of estimated sales returns and allowances based on shipments. |
Quarterly Financial Data (una_3
Quarterly Financial Data (unaudited) - Quarterly Financial Data (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Selected Quarterly Financial Information [Abstract] | |||||||||||
Total revenues | $ 18,821 | $ 17,868 | $ 14,162 | $ 12,703 | $ 14,040 | $ 15,052 | $ 13,416 | $ 12,007 | $ 63,554 | $ 54,515 | $ 52,222 |
Gross profit | 9,191 | 10,579 | 7,202 | 5,517 | 6,932 | 6,529 | 7,800 | 5,788 | 32,489 | 27,049 | 23,405 |
Net loss | $ 6,134 | $ (1,936) | $ (4,520) | $ (6,193) | $ (3,714) | $ (5,453) | $ (2,840) | $ (4,736) | $ (6,515) | $ (16,743) | $ (24,339) |
Net income (loss) per common share, basic and diluted | $ 0.04 | $ (0.01) | $ (0.03) | $ (0.04) | $ (0.02) | $ (0.03) | $ (0.02) | $ (0.03) | |||
Weighted average shares | 158,389 | 157,471 | 157,024 | 156,724 | 156,655 | 156,401 | 155,926 | 155,215 |
Quarterly Financial Data (una_4
Quarterly Financial Data (unaudited) - Quarterly Financial Data (Parenthetical) (Detail) shares in Thousands | 3 Months Ended |
Dec. 31, 2018shares | |
Selected Quarterly Financial Information [Abstract] | |
Weighted average shares on a fully diluted basis | 162,810 |