Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Mar. 01, 2017 | Jun. 30, 2016 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2016 | ||
Document Fiscal Year Focus | 2,016 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | ATRS | ||
Entity Registrant Name | ANTARES PHARMA, INC. | ||
Entity Central Index Key | 1,016,169 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Common Stock, Shares Outstanding | 155,242,371 | ||
Entity Public Float | $ 148,641,000 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Current Assets: | ||
Cash and cash equivalents | $ 27,714,588 | $ 32,898,676 |
Short-term investments | 0 | 15,012,225 |
Accounts receivable | 9,073,173 | 7,952,478 |
Inventories | 5,326,962 | 5,724,397 |
Deferred costs | 1,773,446 | 1,199,217 |
Prepaid expenses and other current assets | 1,376,299 | 3,274,254 |
Total current assets | 45,264,468 | 66,061,247 |
Equipment, molds, furniture and fixtures, net | 17,867,412 | 14,793,084 |
Patent rights, net | 2,044,608 | 2,434,542 |
Goodwill | 1,095,355 | 1,095,355 |
Other assets | 53,607 | 177,943 |
Total Assets | 66,325,450 | 84,562,171 |
Current Liabilities: | ||
Accounts payable | 7,884,983 | 5,187,703 |
Accrued expenses and other liabilities | 5,872,846 | 6,488,032 |
Deferred revenue | 6,149,087 | 5,143,825 |
Total current liabilities | 19,906,916 | 16,819,560 |
Deferred revenue – long term | 1,200,000 | 700,000 |
Total liabilities | 21,106,916 | 17,519,560 |
Stockholders’ Equity: | ||
Preferred Stock: $0.01 par, authorized 3,000,000 shares, none outstanding | ||
Common Stock: $0.01 par; authorized 300,000,000 shares; 155,167,677 and 154,848,512 issued and outstanding at December 31, 2016 and 2015, respectively | 1,551,677 | 1,548,485 |
Additional paid-in capital | 297,826,433 | 295,292,414 |
Accumulated deficit | (253,445,306) | (229,106,502) |
Accumulated other comprehensive loss | (714,270) | (691,786) |
Total Stockholders' Equity | 45,218,534 | 67,042,611 |
Total Liabilities and Stockholders’ Equity | $ 66,325,450 | $ 84,562,171 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2016 | Dec. 31, 2015 |
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 | 200,000,000 |
Common Stock, shares issued | 155,167,677 | 154,848,512 |
Common Stock, shares outstanding | 155,167,677 | 154,848,512 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Revenue: | |||
Product sales | $ 40,318,339 | $ 27,533,042 | $ 13,195,577 |
Development revenue | 10,234,486 | 8,892,121 | 7,246,080 |
Licensing revenue | 166,188 | 7,242,030 | 3,708,938 |
Royalties | 1,503,033 | 1,990,907 | 2,351,070 |
Total revenue | 52,222,046 | 45,658,100 | 26,501,665 |
Cost of revenue: | |||
Cost of product sales | 23,908,659 | 12,925,129 | 9,359,457 |
Cost of development revenue | 4,908,107 | 6,532,554 | 1,877,238 |
Total cost of revenue | 28,816,766 | 19,457,683 | 11,236,695 |
Gross profit | 23,405,280 | 26,200,417 | 15,264,970 |
Operating expenses: | |||
Research and development | 21,126,936 | 19,731,564 | 18,638,016 |
Selling, general and administrative | 26,394,804 | 26,930,832 | 31,740,249 |
Total operating expenses | 47,521,740 | 46,662,396 | 50,378,265 |
Operating loss | (24,116,460) | (20,461,979) | (35,113,295) |
Other income (expense): | |||
Interest income | 79,783 | 60,469 | 76,661 |
Foreign exchange gain (loss) | (2,691) | (47,951) | 156 |
Other, net | (199,436) | (34,385) | (90,237) |
Total other expense | (122,344) | (21,867) | (13,420) |
Net loss before income taxes | (24,238,804) | (20,483,846) | (35,126,715) |
Income tax provision | 100,000 | 175,000 | 25,000 |
Net loss | $ (24,338,804) | $ (20,658,846) | $ (35,151,715) |
Basic and diluted net loss per common share | $ (0.16) | $ (0.14) | $ (0.27) |
Basic and diluted weighted average common shares outstanding | 154,992,124 | 146,594,079 | 130,549,701 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Statement Of Income And Comprehensive Income [Abstract] | |||
Net loss | $ (24,338,804) | $ (20,658,846) | $ (35,151,715) |
Foreign currency translation adjustment | (22,484) | 13,901 | (52,485) |
Comprehensive loss | $ (24,361,288) | $ (20,644,945) | $ (35,204,200) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive Loss [Member] |
Balance at Dec. 31, 2013 | $ 70,713,728 | $ 1,287,406 | $ 243,375,465 | $ (173,295,941) | $ (653,202) |
Balance, shares at Dec. 31, 2013 | 128,740,604 | ||||
Exercise of warrants and options | 3,105,102 | $ 26,692 | 3,078,410 | ||
Exercise of warrants and options, shares | 2,669,223 | ||||
Common stock issued under equity compensation plan, net of shares withheld for taxes | (43,216) | $ 3,335 | (46,551) | ||
Common stock issued under equity compensation plan, net of shares withheld for taxes, shares | 333,538 | ||||
Share-based compensation | 2,624,742 | 2,624,742 | |||
Net loss | (35,151,715) | (35,151,715) | |||
Other comprehensive income (loss) | (52,485) | (52,485) | |||
Balance at Dec. 31, 2014 | 41,196,156 | $ 1,317,433 | 249,032,066 | (208,447,656) | (705,687) |
Balance, shares at Dec. 31, 2014 | 131,743,365 | ||||
Issuance of common stock | 42,850,677 | $ 230,000 | 42,620,677 | ||
Issuance of common stock, shares | 23,000,000 | ||||
Common stock issued under equity compensation plan, net of shares withheld for taxes | (48,951) | $ 852 | (49,803) | ||
Common stock issued under equity compensation plan, net of shares withheld for taxes, shares | 85,147 | ||||
Exercise of options | 30,800 | $ 200 | 30,600 | ||
Exercise of options, shares | 20,000 | ||||
Share-based compensation | 3,658,874 | 3,658,874 | |||
Net loss | (20,658,846) | (20,658,846) | |||
Other comprehensive income (loss) | 13,901 | 13,901 | |||
Balance at Dec. 31, 2015 | 67,042,611 | $ 1,548,485 | 295,292,414 | (229,106,502) | (691,786) |
Balance, shares at Dec. 31, 2015 | 154,848,512 | ||||
Common stock issued under equity compensation plan, net of shares withheld for taxes | (83,631) | $ 2,164 | (85,795) | ||
Common stock issued under equity compensation plan, net of shares withheld for taxes, shares | 216,389 | ||||
Exercise of options | 101,092 | $ 1,028 | 100,064 | ||
Exercise of options, shares | 102,776 | ||||
Share-based compensation | 2,519,750 | 2,519,750 | |||
Net loss | (24,338,804) | (24,338,804) | |||
Other comprehensive income (loss) | (22,484) | (22,484) | |||
Balance at Dec. 31, 2016 | $ 45,218,534 | $ 1,551,677 | $ 297,826,433 | $ (253,445,306) | $ (714,270) |
Balance, shares at Dec. 31, 2016 | 155,167,677 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Cash flows from operating activities: | |||
Net loss | $ (24,338,804) | $ (20,658,846) | $ (35,151,715) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Share-based compensation expense | 2,519,750 | 3,658,874 | 2,624,742 |
Depreciation and amortization | 1,860,682 | 1,569,848 | 1,224,217 |
Loss on disposal of equipment | 261,814 | 167,097 | 39,983 |
Write-off of capitalized patent costs | 0 | 31,501 | 0 |
Increase in inventory reserve | 748,378 | 700,000 | 3,550,000 |
Amortization of premiums and discounts | 12,225 | 10,313 | 20,036 |
Changes in operating assets and liabilities: | |||
Accounts receivable | (1,137,543) | (4,422,689) | (2,478,494) |
Inventories | (350,943) | (564,473) | (2,948,873) |
Prepaid expenses and other current assets | 1,921,937 | (934,356) | (617,121) |
Deferred costs | (574,229) | 714,704 | (1,538,148) |
Other assets | 100,000 | 148,000 | 545,059 |
Accounts payable | 2,858,884 | (3,494,536) | 2,688,054 |
Accrued expenses and other liabilities | (582,295) | 905,882 | 221,086 |
Deferred revenue | 1,505,202 | (6,030,160) | 5,487,873 |
Net cash used in operating activities | (15,194,942) | (28,198,841) | (26,333,301) |
Cash flows from investing activities: | |||
Purchases of equipment, molds, furniture and fixtures | (4,879,509) | (5,643,043) | (4,663,313) |
Additions to patent rights | (127,156) | (1,043,628) | (989,790) |
Proceeds from maturities of investment securities | 15,000,000 | 6,000,000 | 24,000,000 |
Purchases of investment securities | (15,037,675) | ||
Net cash provided by (used in) investing activities | 9,993,335 | (15,724,346) | 18,346,897 |
Cash flows from financing activities: | |||
Proceeds from issuance of common stock, net | 42,850,677 | ||
Proceeds from exercise of stock options and warrants | 101,092 | 30,800 | 3,105,102 |
Taxes paid related to net share settlement of equity awards | (83,631) | (87,770) | (154,397) |
Net cash provided by financing activities | 17,461 | 42,793,707 | 2,950,705 |
Effect of exchange rate changes on cash | 58 | (733) | (2,648) |
Net decrease in cash and cash equivalents | (5,184,088) | (1,130,213) | (5,038,347) |
Cash and cash equivalents: | |||
Beginning of year | 32,898,676 | 34,028,889 | 39,067,236 |
End of year | 27,714,588 | 32,898,676 | 34,028,889 |
Supplemental disclosure of non-cash investing activities: | |||
Purchases of equipment, molds, furniture and fixtures recorded in accounts payable and accrued expenses | 424,389 | 641,379 | 1,118,925 |
Additions to patent rights recorded in accounts payable and accrued expenses | $ 44,589 | $ 21,027 | $ 949,631 |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Description of Business | 1. Description of Business Antares Pharma, Inc. (“Antares” or the “Company”) is an emerging, specialty pharmaceutical company focused on the development and commercialization of self-administered parenteral pharmaceutical products and technologies. The Company develops and manufactures, for itself or with partners, novel therapeutic products using its advanced drug delivery technology to enhance the existing drug compounds and delivery methods. The subcutaneous injection technology platforms include the VIBEX ® The Company launched its proprietary product OTREXUP ® ® The Company, with its partner Teva, launched Sumatriptan Injection USP, indicated in the U.S. for the acute treatment of migraine and cluster headache in adults, in June 2016. In December 2015, the Company received FDA approval for an Abbreviated New Drug Application (ANDA) for 4 mg/0.5 mL and 6 mg/0.5 mL single-dose prefilled syringe auto-injectors, a generic equivalent to Imitrex ® ® ® The Company is developing VIBEX ® ® |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated financial statements include the accounts of Antares Pharma, Inc. and its two wholly-owned foreign subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. Use of Estimates The preparation of consolidated financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The Company’s significant accounting estimates relate to the revenue recognition periods for license revenues, OTREXUP ® 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 by the U.S. parent are in currencies other than the U.S. dollar and are subject to foreign currency exchange rate fluctuations. Foreign currency transaction gains and losses are included in foreign exchange gain (loss) in the consolidated statements of operations. Cash and Cash Equivalents Cash consists of demand deposits at commercial banks. The Company also invests in cash equivalents consisting of highly liquid investments in money market funds with original maturities of three months or less. Allowance for Doubtful Accounts Trade accounts receivable are stated at the amount the Company expects to collect. The Company maintains allowances for doubtful accounts for estimated losses resulting from the inability of its customers to make required payments. The Company considers the following factors when determining the collectability of specific customer accounts: customer credit-worthiness, past transaction history with the customer, current economic industry trends, and changes in customer payment terms. At December 31, 2016, the Company’s accounts receivable balance is due primarily from Teva and distributors of OTREXUP ® Inventories Inventories are stated at the lower of cost or market. 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. 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 established reserve for excess, dated or obsolete inventory was $900,000 and $800,000 at December 31, 2016 and 2015, respectively. In 2016, the Company wrote off inventory totaling $650,000 and increased the reserve for excess, dated or obsolete inventory by approximately $750,000. In 2015, the Company wrote off $3,500,000 of inventory and increased the reserve for excess, dated or obsolete inventory by approximately $700,000. 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. Depreciation expense was $1,326,378, $1,034,057 and $880,400 for the years ended December 31, 2016, 2015 and 2014, respectively. Patent Rights The Company capitalizes the costs of obtaining patent rights when there are projected future cash flows for marketed or partnered products associated with the patent. These capitalized costs are being amortized on a straight-line basis over the shorter of the life of the patent or the estimated useful life of the patent, which typically is over periods ranging from five to fifteen years beginning on the earlier of the date the patent is issued or the first commercial sale of product utilizing such patent rights. The Company periodically reviews capitalized patent costs to identify any amounts to be charged to expense for patents that are no longer being pursued or for which there are no future revenues or cash flows anticipated. The Company capitalizes external legal patent defense costs and costs for pursuing patent infringements when it determines that a successful outcome is probable and will lead to an increase in the value of the patent. The capitalized costs are amortized over the remaining life of the related patent. If changes in the anticipated outcome were to occur that reduce the likelihood of a successful outcome of the entire action to less than probable, the capitalized costs would be charged to expense in the period in which the change is determined. The gross carrying amount and accumulated amortization of patents, which are the only intangible assets of the Company subject to amortization, was $4,659,103 and $2,614,495, respectively at December 31, 2016, and $4,533,439 and $2,098,897, respectively, at December 31, 2015. The Company’s estimated aggregate patent amortization expense for the next five years is approximately $541,000, $541,000, $311,000, $92,000 and $71,000 in 2017, 2018, 2019, 2020 and 2021, respectively. Patent amortization expense for the years ended December 31, 2016, 2015 and 2014 was $534,304, $535,791 and $343,817, respectively, and is recorded in selling, general and administrative expenses in the consolidated statements of operations. In 2015, the Company expensed $31,501 of capitalized patent costs for abandoned patents or patents no longer connected with current products. There was no write-off of patent costs in 2016 and 2014, respectively. Impairment of Long-Lived Assets and Intangibles Long-lived assets, 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. Such circumstances could include, but are not limited to: (1) a significant adverse change in legal factors or in business climate, (2) unanticipated competition, (3) an adverse action or assessment by a regulator, or (4) a sustained significant drop in the Company’s stock price. When evaluating whether goodwill is potentially impaired, the Company compares the fair value of the reporting unit to the carrying amount, including goodwill. If the carrying amount is found to be greater, then the Company would determine the implied fair value of goodwill by subtracting the fair value of all the identifiable net assets other than goodwill from the fair value of the reporting unit and record an impairment loss, if any, for the excess of the carrying value of goodwill over the implied fair value. At December 31, 2016, the Company had goodwill with a carrying value of $1,095,355 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, 2016, 2015, and 2014, respectively. Fair Value of Financial Instruments The carrying value of certain of the Company’s financial instruments, including accounts receivable and accounts payable, approximate fair value due to the short-term nature of the instruments. From time to time, the Company invests in U.S. Treasury bills or U.S. Treasury notes that are classified as held-to-maturity because the Company has the positive intent and ability to hold the securities to maturity. The investment securities are carried at amortized cost and fair value is determined by quoted market prices, which is a Level 1 fair value measurement. At December 31, 2015, the fair value of the Company’s short-term investments approximated the carrying values and no short-term investments were held at December 31, 2016. Revenue Recognition The Company recognizes revenue from the sale of products, development project milestones, license fees and royalties. Revenue is recognized when all of the following criteria are met: persuasive evidence of the arrangement exists; delivery has occurred and we have no remaining obligations; the fee is fixed or determinable; and collectability is reasonably assured. OTREXUP ® The Company began detailing OTREXUP ® ® ® ® ® The Company recognized $15,145,214, $13,249,715 and $7,309,603 in OTREXUP ® ® The Company will continue to recognize revenue upon the earlier to occur of prescription units dispensed or expiration of the right of return until there has been sufficient history to estimate product returns. When it becomes possible to reasonably estimate product returns, a one-time increase in net revenue will be recorded to recognize revenue previously deferred. In addition, the costs of manufacturing OTREXUP ® Product Sales Allowances The Company recognizes product sales allowances as a reduction of product sales in the same period the related revenue is recognized. Product sales allowances are based on amounts owed or to be claimed on the related sales. These estimates take into consideration the terms of our agreements with customers and third-party payors and the levels of inventory within the distribution channels that may result in future rebates or discounts taken. In certain cases, such as patient support programs, the Company recognizes the cost of patient discounts as a reduction of revenue based on estimated utilization. If actual future results vary, it may be necessary to adjust these estimates, which could have an effect on product revenue in the period of adjustment. Product sales allowances include: Wholesaler Distribution Fees . Distribution fees are paid to certain wholesale distributors based on contractually determined rates. The Company accrues the fee on shipment to the respective wholesale distributors and recognizes the fee as a reduction of revenue in the same period the related revenue is recognized. Prompt Pay Discounts . The Company offers cash discounts to its customers, generally 2% of the sales price, as an incentive for prompt payment. The Company accounts for cash discounts by reducing accounts receivable by the prompt pay discount amount and recognizes the discount as a reduction of revenue in the same period the related revenue is recognized. Chargebacks . The Company provides discounts primarily to authorized users of the Federal Supply Schedule (“FSS”) of the General Services Administration under an FSS contract negotiated by the Department of Veterans Affairs and various organizations under Medicaid contracts and regulations. These entities purchase products from the wholesale distributors at a discounted price, and the wholesale distributors then charge back to the Company the difference between the current wholesale acquisition cost and the price the entity paid for the product. The Company will estimate and accrue chargebacks based on estimated wholesaler inventory levels, current contract prices and historical chargeback activity. Chargebacks are recognized as a reduction of revenue in the same period the related revenue is recognized. Rebates . The Company participates in certain rebate programs, which provide discounted prescriptions to qualified insured patients. Under these rebate programs, the Company will pay a rebate to the third-party administrator of the program, generally two to three months after the quarter in which prescriptions subject to the rebate are filled. The Company estimates and accrues for these rebates based on current contract prices, historical and estimated future percentages of product sold to qualified patients. Rebates are recognized as a reduction of revenue in the same period the related revenue is recognized. Patient Discount Programs. The Company offers discount card programs to patients for OTREXUP ® Sumatriptan Revenue Recognition Under a license, supply and distribution agreement with Teva for an auto-injector product containing sumatriptan, the Company produces devices and assembles final product for shipment to Teva, and Teva is responsible for commercial distribution and sale of the product. The Company is compensated, and recognizes revenue, at cost for shipments of product delivered to Teva. The Company is also entitled to receive 50 percent of the future net profits from commercial sales made by Teva. Given the relatively short time period since product launch and limited historical sales data, management is not currently able to estimate the profit margin the Company expects to receive from commercial sales made by Teva. Therefore, revenue from the profit sharing arrangement is currently recognized in the period following the commercial sale by Teva when amounts become fixed and determinable and payable to the Company, which is within 45 days after the end of each fiscal quarter in which commercial sales are made. In future periods, management may be able to reasonably estimate and recognize revenue from the profit sharing arrangement when product is sold by Teva. Other Revenue Recognition The Company sells its proprietary reusable needle-free injectors and related disposable products to pharmaceutical partners and through medical product distributors. The Company’s reusable injectors and related disposable products are not interchangeable with any competitive products and must be used together. The Company recognizes revenue upon shipment when title transfers. The Company offers no price protection or return rights other than for customary warranty claims. Sales terms and pricing are governed by license and distribution agreements. Revenue arrangements with multiple deliverables are divided into separate units of accounting if certain criteria are met, including whether the deliverable has stand-alone value to the customer, the customer has a general right of return relative to the delivered item and delivery or performance of the undelivered item is probable and substantially within the vendor’s control. Arrangement consideration is allocated at the inception of the arrangement to all deliverables on the basis of their relative selling price. The selling price for each deliverable is determined using: (i) vendor-specific objective evidence of selling price (“VSOE”), if it exists, (ii) third-party evidence of selling price (“TPE”) if VSOE does not exist, and (iii) the Company’s best estimate of the selling price if neither VSOE nor TPE exists. Revenue, excluding variable consideration, is recognized upon completion of deliverables based on the relative selling price of each deliverable that was assigned at inception of the arrangement. Royalty revenue is recognized in the period in which it is earned when the Company has information available to determine the amount; however, the majority of the Company’s royalty revenues are recognized one quarter in arrears as information is typically not available to determine quarterly royalty earnings until royalty statements are received from partners. Share-Based Compensation The Company utilizes share based compensation in the form of stock options, restricted stock units (“RSUs”) and performance-based restricted stock units (“PSUs”). The Company records compensation expense associated with share based awards granted to employees at the fair value of the award on the date of grant. The Company uses the Black-Scholes option valuation model to determine the fair value of stock options. The fair values of RSU and PSU grants containing service or performance conditions are based on the market value of the Company’s Common Stock on the date of grant. The fair value of PSUs containing a market condition are estimated using a Monte Carlo simulation. Pre-vesting forfeitures are estimated in the determination of total stock-based compensation cost based on Company experience. The value of the portion of the award that is ultimately expected to vest is expensed ratably over the requisite service period as compensation expense in the consolidated statement of operations. The determination of fair value of share-based payment awards on the grant date requires significant judgment. Assumptions concerning the Company’s stock price volatility and projected employee exercise behavior over the contractual life of the award can significantly impact the estimated fair value of an award. Product Warranty The Company provides a warranty on its reusable needle-free injector devices. The warranty period on a needle-free injector device is typically 24 months from either the date of retail sale of the device by a dealer or distributor or the date of shipment to a customer if specified by contract. The Company recognizes the estimated cost of warranty obligations at the time the products are shipped based on historical claims incurred by the Company. Actual warranty claim costs could differ from these estimates. At December 31, 2016 and 2015, the Company had $100,000 in warranty liability reserves. 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. All potentially dilutive common shares were excluded from the calculation because they were anti-dilutive for all periods presented. Potentially dilutive securities excluded from dilutive loss per share were 11,313,909, 9,480,497 and 7,245,485 at December 31, 2016, 2015 and 2014, respectively. Segment Information Operating segments are components of an enterprise for which separate financial information is available and is evaluated regularly by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company’s chief operating decision maker currently evaluates the Company’s operations as a whole from a number of different operational perspectives, including but not limited to, on a product-by-product, customer and partner basis. The Company derives all significant revenues from self-administered parenteral pharmaceutical products and technologies, and has a single reportable operating segment of business. Accordingly, the Company does not report more than one segment; nevertheless, management periodically evaluates whether the Company continues to have one single reportable segment of business. Going Concern The Company adopted Auditing Standard Update (“ ASU”) No. 2014-15, Presentation of Financial Statements - Going Concern: Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern , which defines management’s responsibility to evaluate whether there is substantial doubt about an organization’s ability to continue as a going concern and to provide related footnote disclosures, if required. As of December 31, 2016, the Company had cash and cash equivalents of $27,714,588 and no debt obligations. Based on management’s evaluation, management concluded there is not substantial doubt about the Company’s ability to meet its obligations within one year from the date the financial statements were issued Recent Accounting Pronouncements Not Yet Adopted In May 2014, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2014-09, Revenue from Contracts with Customers The Company is in the process of evaluating the impact the adoption of this standard will have on its consolidated financial statements and has performed an initial review of its major contracts with customers. Based on the initial reviews, the Company believes the adoption of the new standard may accelerate the timing of revenue recognition for product sales and development revenue under certain license, development and supply agreements, and will require management to estimate and potentially recognize certain variable revenue streams such as royalties and profit sharing arrangements earlier at an amount it believes will not be subject to significant reversal. The Company anticipates adopting the new revenue recognition standard on the effective date of January 1, 2018 utilizing the modified retrospective method of adoption, under which the cumulative effect of the change is recognized as an adjustment to the opening balance of the accumulated deficit within the consolidated balance sheet, and prior reporting periods are not retrospectively adjusted. No significant changes to business processes or systems are currently expected to be necessary. In July 2015, the FASB issued ASU No. 2015-11, Simplifying the Measurement of Inventory. The new standard changes the measurement principle for inventory from the lower of cost or market to lower of cost and net realizable value. The standard is effective for public entities for annual and interim periods beginning after December 15, 2016 and entities are required to disclose the nature and reason for the change in accounting principle in the first interim and annual period of adoption. The adoption of this standard is not expected to have a significant impact on the consolidated results of operations and financial position of the Company. In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) In March 2016, the FASB issued ASU No. 2016-09, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting “ In January 2017, the FASB issued ASU 2017-04, Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment |
Composition of Certain Financia
Composition of Certain Financial Statement Captions | 12 Months Ended |
Dec. 31, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Composition of Certain Financial Statement Captions | 3. Composition of Certain Financial Statement Captions December 31, December 31, 2016 2015 Inventories: Raw material $ 142,491 $ 305,149 Work in process 2,429,075 1,539,319 Finished goods 2,755,396 3,879,929 $ 5,326,962 $ 5,724,397 Equipment, molds, furniture and fixtures: Furniture, fixtures and office equipment $ 2,234,222 $ 2,058,146 Production molds and equipment 10,582,575 8,481,005 Molds and tooling in process 10,149,596 8,169,543 Less accumulated depreciation (5,098,981 ) (3,915,610 ) $ 17,867,412 $ 14,793,084 Patent rights: Patent rights $ 4,659,103 $ 4,533,439 Less accumulated amortization (2,614,495 ) (2,098,897 ) $ 2,044,608 $ 2,434,542 Accrued expenses and other liabilities: Accrued employee compensation and benefits $ 2,703,470 $ 3,018,987 OTREXUP ® 1,483,699 751,318 Other liabilities 1,685,677 2,717,727 $ 5,872,846 $ 6,488,032 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2016 | |
Equity [Abstract] | |
Stockholders' Equity | 4 . Stockholders’ Equity The Company amended its certificate of incorporation to increase the total number of authorized shares of capital stock from 203,000,000 to 303,000,000 and to increase the number of authorized shares of common stock, par value $0.01 per share, of the Company from 200,000,000 shares to 300,000,000 shares. The amendment was approved and adopted by a vote of the stockholders at the Company’s annual meeting of stockholders on June 2, 2016. On May 11, 2015, the Company completed an underwritten offering of 23,000,000 shares of its common stock at a price to the public of $2.00 per share. The Company received net proceeds of approximately $42.9 million after deducting underwriting discounts, commissions and offering expenses paid by the Company. The Company has used the net proceeds from the offering for general corporate purposes including research and development activities. |
Share Based Compensation
Share Based Compensation | 12 Months Ended |
Dec. 31, 2016 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share Based Compensation | 5. Share-Based Compensation The Company’s 2008 Equity Compensation Plan (the “Plan”) was amended and restated pursuant to stockholder approval in June 2016 in order to increase the number of shares available for issuance under the Plan, extend the term of the Plan, impose a one-year minimum vesting requirement and provide for double trigger accelerated vesting for certain awards in the event of a change in control. The Plan allows for grants in the form of incentive stock options, nonqualified stock options, stock units, stock awards, stock appreciation rights, and other stock-based awards. All of the Company’s officers, directors, employees, consultants and advisors are eligible to receive grants under the Plan. Under the Plan, the maximum number of shares authorized for issuance is 32,200,000 and the maximum number of shares of stock that may be granted to any one participant during a calendar year is 4,000,000 shares. Options to purchase shares of common stock are granted at exercise prices not less than 100% of fair market value on the dates of grant. The term of each option is 10 years and the options typically vest in quarterly installments over a three-year period. As of December 31, 2016, the Plan had approximately 9,400,000 shares available for grant. Stock option exercises are satisfied through the issuance of new shares. Stock Options Stock option activity under the Plan as of and for the three years ended December 31, 2016 is as follows: Weighted Weighted Average Average Remaining Aggregate Number of Exercise Contractual Intrinsic Shares Price ($) Term (Years) Value ($) Outstanding at December 31, 2013 7,697,892 1.89 Granted/Issued 2,596,201 2.89 Exercised (2,124,123 ) 1.21 3,585,453 Cancelled/Forfeited (924,485 ) 3.41 Outstanding at December 31, 2014 7,245,485 2.25 Granted/Issued 2,984,010 2.23 Exercised (20,000 ) 1.54 — Cancelled/Forfeited (728,998 ) 2.92 Outstanding at December 31, 2015 9,480,497 2.19 Granted/Issued 4,029,500 1.14 Exercised (142,493 ) 1.23 121,782 Cancelled/Forfeited (2,053,595 ) 2.13 Outstanding at December 31, 2016 11,313,909 1.84 7.0 7,741,133 Exercisable at December 31, 2016 7,789,081 2.04 6.1 513,003 As of December 31, 2016, there was $2,067,000 of total unrecognized compensation costs related to nonvested outstanding stock options that are expected to be recognized over a weighted average period of approximately 1.9 years. Stock option expense recognized in 2016, 2015 and 2014 was approximately $2,039,000, $2,883,000 and $2,060,000, respectively. The per share weighted average fair value of options granted during 2016, 2015 and 2014 was estimated as $0.57, $1.13 and $1.64, 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, 2016 2015 2014 Risk-free interest rate 1.3 % 1.3 % 1.6 % Annualized volatility 51.7 % 53.5 % 60.7 % Weighted average expected life, in years 6.0 6.0 6.0 Expected dividend yield 0.0 % 0.0 % 0.0 % Option exercises during 2016, 2015 and 2014 resulted in proceeds of $101,092, $30,800 and $2,564,987, respectively, and in the issuance of shares of common stock of 102,776 in 2016, 20,000 in 2015 and 2,124,123 in 2014. In 2016, certain options were net exercised, whereby the Company withheld 39,717 shares, the fair value of which was equivalent to the aggregate exercise price and tax withholding on the date of exercise. Long Term Incentive Program The Company’s Board of Directors has approved a long term incentive program (“LTIP”) for the benefit of the Company’s senior executives. Pursuant to the LTIP, the Company’s senior executives have been awarded stock options, restricted stock units (“RSU”) and performance stock units (“PSU”) with targeted values based on similar award structures granted by the Company’s peer group. The stock options have a ten-year term, have an exercise price equal to the closing price of the Company’s common stock on the date of grant, vest in quarterly installments over three years, were otherwise granted on the same standard terms and conditions as other stock options granted pursuant to the Plan and are included in the stock options table above. The RSUs vest in three equal annual installments, and the PSU awards vest and convert into shares of the Company’s common stock based on the Company’s attainment of certain performance goals over a performance period, which is typically three to five years. In 2016 and 2015, the value of the annual award for each senior executive was delivered 33% in the form of PSUs, 33% in the form of RSUs and 34% in the form of stock options. In 2014, the value of the annual award for each senior executive was delivered 50% in the form of PSUs, 25% in the form of shares of RSUs and 25% in the form of stock options. The performance stock unit awards and restricted stock unit awards granted under the long term incentive program are summarized in the following table: Performance Stock Units Restricted Stock Units Number of Shares Weighted Average Date Fair Value ($) Number of Shares Weighted Average Grant Date Fair Value ($) Outstanding at December 31, 2013 406,663 3.19 155,724 3.96 Granted 651,980 3.02 325,991 3.02 Vested/settled (87,519 ) 2.03 (51,907 ) 3.96 Forfeited/expired (507,582 ) 3.26 (198,684 ) 3.45 Outstanding at December 31, 2014 463,542 3.08 231,124 3.07 Granted 664,391 2.09 664,391 2.18 Vested/settled — (112,285 ) 2.92 Forfeited/expired (171,755 ) 2.69 (68,402 ) 2.47 Outstanding at December 31, 2015 956,178 2.40 714,828 2.32 Granted 750,500 1.15 750,500 1.12 Vested/settled (16,835 ) 3.96 (264,001 ) 2.41 Forfeited/expired (342,554 ) 2.17 (378,669 ) 1.91 Outstanding at December 31, 2016 1,347,289 1.50 822,658 1.39 In each of the years in the three-year period ended December 31, 2016, the LTIP awards include PSUs that will be earned based on the Company’s total shareholder return (“TSR”) as compared to the Nasdaq Biotechnology Index (“NBI”) at the end of the respective annual performance periods. Depending on the outcome of the performance goal, a recipient may ultimately earn a number of shares greater or less than their target number of shares granted, ranging from 0% to 150% of the PSUs granted. The fair values of the TSR PSUs granted were determined using a Monte Carlo simulation and utilized the following inputs and assumptions: 2016 Award 2015 Award 2014 Award Closing stock price on grant date $ 1.12 $ 2.18 $ 3.09 Performance period starting price $ 1.29 $ 2.52 $ 4.08 Term of award (in years) 2.58 2.59 2.59 Volatility 70.1 % 60.5 % 50.9 % Risk-free interest rate 0.97 % 0.83 % 0.60 % Expected dividend yield 0.00 % 0.00 % 0.00 % Fair value per TSR PSU $ 1.25 $ 1.71 $ 2.64 The performance period starting price is measured as the average closing price over the last 20 trading days prior to the performance period start. The Monte Carlo simulation model also assumed correlations of returns of the prices of the Company’s common stock and the common stocks of the NBI companies and stock price volatilities of the NBI companies. The fair value of the target number of shares that can be earned under the TSR PSUs is being recognized as compensation expense over the term of the award. In connection with PSU awards, including both TSR based awards and awards with defined performance goals considered probable of achievement, the Company recognized total compensation expense of approximately $68,000 and $250,000 in 2016 and 2015, respectively, and a net expense reduction of $3,000 in 2014. The net expense reduction was primarily the result of award forfeitures and the reversal of expense associated with awards previously granted to senior executives who left the Company in 2014. Compensation expense recognized in 2016, 2015 and 2014 in connection with the RSUs was $413,000, $526,000 and $212,000, respectively. In 2016, 2015 and 2014, a portion of the LTIP awards were net-share settled such that the Company withheld shares with value equivalent to the employees’ minimum statutory obligation for the applicable income and other employment taxes, and remitted the cash to the appropriate taxing authorities. The total shares withheld were 73,888, 39,665 and 38,768 in 2016, 2015 and 2014, 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 $83,631, $87,770 and $154,397 in 2016, 2015 and 2014, respectively, and are reflected as a financing activity within the Consolidated Statements of Cash Flows. These net-share settlements reduced the number of shares that would have otherwise been issued as a result of the vesting and did not represent an expense to the Company. Warrants There were no outstanding warrants or warrant activity in 2016 or 2015. In 2014, warrants were exercised at $1.00 per share, resulting in proceeds of $545,115 to the Company and the issuance of 545,100 shares of common stock. |
Employee 401(k) Savings Plan
Employee 401(k) Savings Plan | 12 Months Ended |
Dec. 31, 2016 | |
Compensation And Retirement Disclosure [Abstract] | |
Employee 401(k) Savings Plan | 6. Employee 401(k) Savings Plan The Company sponsors a 401(k) defined contribution retirement savings plan that covers all U.S. employees who have met minimum age and service requirements. Under the plan, eligible employees may contribute up to 50% of their annual compensation into the plan up to the IRS annual limits. The Company makes elective contributions to the plan allocated in proportion to employee contributions. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2016 | |
Leases [Abstract] | |
Leases | 7 . Leases The Company has non-cancellable operating leases for its corporate headquarters facility in Ewing, New Jersey, and its office, research and development facility in Plymouth, Minnesota, a suburb of Minneapolis. The leases require payment of all executory costs such as maintenance and property taxes. Rent expense incurred for the years ended December 31, 2016, 2015 and 2014 was $679,693, $672,210 and $611,818, respectively. Future minimum lease payments under operating leases with remaining terms in excess of one year as of December 31, 2016 were as follows: Amount 2017 $ 611,067 2018 622,716 2019 565,955 2020 232,865 2021 238,232 Thereafter 59,896 Total future minimum lease payments $ 2,330,731 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 8 . Income Taxes 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, 2016. In the U.S., the Company incurred losses for both book and tax purposes for the year ended December 31, 2016, and, accordingly, no income taxes were provided. In Switzerland, net operating loss carryforwards were used to fully offset taxable income of approximately $13,000, $1,127,000 and $177,000 in the years ended December 31, 2016, 2015 and 2014, respectively. Income (loss) before income taxes was derived from the following jurisdictions: 2016 2015 2014 U.S. $ (24,228,608 ) $ (21,831,232 ) $ (35,359,378 ) Switzerland (10,196 ) 1,347,386 232,663 $ (24,238,804 ) $ (20,483,846 ) $ (35,126,715 ) Effective tax rates differ from statutory income tax rates in the years ended December 31, 2016, 2015 and 2014 are as follows: 2016 2015 2014 Statutory income tax rate (34.0 )% (34.0 )% (34.0 )% State income taxes (6.8 ) (5.7 ) (3.7 ) Valuation allowance increase 35.9 35.2 37.8 Effect of foreign operations — (1.3 ) (0.2 ) Change in unused net operating loss and credit carryforwards 3.7 2.8 (0.2 ) Nondeductible items 1.6 3.9 0.4 0.4 % 0.9 % 0.1 % Deferred tax assets (liabilities) as of December 31, 2016 and 2015 consist of the following: 2016 2015 Gross deferred tax assets: Net operating loss carryforward – U.S. $ 58,206,000 $ 49,450,000 Net operating loss carryforward – Switzerland 65,000 1,526,000 Research and development tax credit carryforward 5,477,000 4,707,000 Deferred revenue 438,000 301,000 Stock-based compensation 2,678,000 2,201,000 Inventory reserve 364,000 315,000 Compensation accruals 996,000 1,006,000 Other 378,000 241,000 68,602,000 59,747,000 Gross deferred tax liabilities – depreciation and amortization (844,000 ) (753,000 ) Less valuation allowance (67,758,000 ) (58,894,000 ) Net deferred tax asset $ — $ 100,000 The valuation allowance for deferred tax assets as of December 31, 2016 and 2015 was $67,758,000 and $58,894,000, respectively. The total valuation allowance increased $8,864,000 for the year ended December 31, 2016 and increased $7,853,000 for the year ended December 31, 2015. At December 31, 2016 and 2015, the Company had deferred tax assets, net of valuation allowances, of zero and $100,000, respectively. 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. In 2015 and 2014, the Switzerland entities generated taxable income of $1,127,000 and $177,000, respectively, and the Company recognized tax expense of $175,000 and $25,000, respectively, realizing the benefit of $175,000 and $25,000, respectively of deferred tax assets associated with NOL carryforwards in Switzerland. However, in 2016, the Swiss entities only generated taxable income of $13,000. Management determined it was more likely than not that the deferred tax assets associated with NOL carryforwards in Switzerland will not be realized and has recorded a full valuation allowance as of December 31, 2016. After considering the evidence with respect to the U.S. deferred tax assets, management determined that as of December 31, 2016, 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, 2016, of $156,343,000, which, subject to limitations of Internal Revenue Code (“IRC”) Section 382, is available to reduce income taxes payable in future years. If not used, this carryforward will expire in years 2018 through 2036. Included in the federal net operating loss is $5,075,000 of loss generated by deductions related to equity-based compensation, the tax effect of which will be recorded to additional paid in capital when utilized. Additionally, the Company has research credit carryforwards of $5,051,000. These credits expire in years 2018 through 2036. 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, 2016, of $437,000, which is available to reduce income taxes payable in future years. If not used, this carryforward will expire in 2018. As of December 31, 2016 and 2015, 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 2011 and thereafter. There are no tax examinations currently in progress. |
Revenue Arrangements
Revenue Arrangements | 12 Months Ended |
Dec. 31, 2016 | |
Deferred Revenue Disclosure [Abstract] | |
Revenue Arrangements | 9 . Revenue Arrangements Teva License, Development and Supply Agreements In November 2012, the Company entered into a license, supply and distribution agreement with Teva for an auto injector product containing sumatriptan for the treatment of migraines. The Company manufactures the device and assembles the final product for shipment to Teva for distribution. Teva supplies sumatriptan in prefilled syringes and is responsible for commercial distribution of the product in the U.S. Under the agreement, the Company received an upfront payment and a milestone payment upon commercial launch in June 2016. In addition, the Company is compensated for devices it delivers to Teva, and shares in net profits from product sales made by Teva, which are split 50/50 between the Company and Teva. The term of the agreement continues seven years from commercial launch, with automatic one year renewals. In December 2007, the Company entered into a license, development and supply agreement with Teva under which the Company is developing two disposable pen injector devices for use with the patient-administered pharmaceutical products exenatide and teriparatide. Under the agreement, an upfront payment, development milestones, and royalties on Teva’s product sales, as well as a purchase price for each device sold are to be received by the Company. In January 2011, this agreement was amended such that Teva pays for all development work and tooling associated with device development. This agreement will continue until the later of December 2017 or the expiration date of the last to expire patent covering the device or product that is filed no later than 12 months after FDA approval, and will be automatically renewed for successive periods of two years each. In July 2006, the Company entered into an exclusive license, development and supply agreement with Teva for an epinephrine auto injector product. Pursuant to the agreement, Teva is obligated to purchase all of its delivery device requirements to be marketed in the U.S. and Canada from the Company. The Company was entitled to an upfront cash payment, milestone fees, a negotiated purchase price for each device sold, as well as royalties on sales of product. This agreement will continue until the expiration date of the last to expire patent covering the device or product that is filed no later than 12 months after FDA approval. Under a separate agreement, Teva agreed to provide the Company with device orders of an undisclosed amount, to make a milestone payment to the Company upon FDA approval of epinephrine auto injector, and to assume all litigation costs related to a patent litigation between Teva and Meridian Medical, a Pfizer subsidiary. AMAG Development and License Agreement In September 2014 the Company entered into a development and license agreement with Lumara Health, Inc., which was later acquired by AMAG Pharmaceuticals, Inc. (AMAG) in November 2014. Under the agreement, the Company granted an exclusive, worldwide, royalty-bearing license, with the right to sublicense, to certain intellectual property rights, including know-how, patents and trademarks, to develop, use, sell, offer for sale and import and export an auto-injection system for use with 17-alpha hydroxyprogesterone caproate, a progestin drug indicated to reduce the risk of preterm birth. The Company received an upfront payment for its license and development work, and is entitled to receive milestones payments, payment of purchase price for each device sold, and royalties on net product sales. Under the arrangement, AMAG is responsible for the clinical development and preparation, submission and maintenance of all regulatory applications, supply of the drug to be used in the product, and to market and sell the product. The Company is the exclusive supplier of the auto-injection system devices for the product and is responsible for the manufacture and supply of the devices and final assembly and packaging of the product. The Company is entitled to receive royalties on net sales of products commencing on product launch in a particular country until the product is no longer developed, marketed, sold or offered for sale in such country. The royalty rates range from high single digit to low double digits and are tiered based on levels of net sales of products and decrease after the expiration of licensed patents or where there are generic equivalents to the auto injector product being sold in a particular country. The Company identified and evaluated a number of deliverables in the agreement and concluded that the manufacturing deliverable has stand-alone value but the license and development work do not have value on a stand-alone basis. As a result, the license and development deliverables do not qualify for treatment as separate units of accounting, and accordingly, are accounted for as a single unit of accounting and will be recognized as revenue during the estimated development period. LEO Pharma Promotion and License Agreement In November 2013, the Company entered into a promotion and license agreement with LEO Pharma. Under this agreement the Company granted LEO Pharma the exclusive right to promote OTREXUP ® ® The Company identified and evaluated a number of deliverables in the agreement and concluded that none of the deliverables had value on a stand-alone basis. As a result, these deliverables did not qualify for treatment as separate units of accounting, and accordingly, were accounted for as a single unit of accounting with each of the milestone payments deferred and allocated to the deliverables and recognized as revenue over the 35 month estimated life of the agreement. Effective June 23, 2015, the agreement with LEO was terminated and the Company regained the exclusive U.S. marketing rights to OTREXUP ® Ferring Agreements In November 2009, the Company entered into an Exclusive License Agreement with Ferring, under which the Company licensed certain of its patents and agreed to transfer know-how for its transdermal gel technology for certain pharmaceutical products. The agreement will remain in effect until the last applicable patent under the agreement expires. Under the terms of the agreement, the Company is entitled to receive milestone payments as certain defined milestones are achieved. In 2015, the Company received and recognized a $1.0 million milestone under this arrangement, which was earned in connection with Ferring filing a NDA related to the patented licensed technology. The Company entered into a License Agreement with Ferring in 2003 under which the Company licensed certain of its intellectual property and extended the territories available to Ferring for use of certain of the Company’s reusable needle-free injector devices. Specifically, the Company granted to Ferring an exclusive, perpetual, irrevocable, royalty-bearing license, within a prescribed manufacturing territory, to manufacture certain of the Company’s reusable needle-free injector devices for the field of human growth hormone. The Company granted to Ferring similar non-exclusive rights outside of the prescribed manufacturing territory. As consideration for the license grants, Ferring paid the Company an upfront payment upon execution of the License Agreement, and an additional milestone in 2003. Ferring also pays the Company royalties for each device manufactured by or on behalf of Ferring, including devices manufactured by the Company. These royalty obligations expire, on a country-by-country basis, when the respective patents for the products expire, despite the fact that the License Agreement does not itself expire until the last of such patents expires. The license fees were initially deferred and are being recognized in income over the period from 2003 through 2016. In March 2007, the Company amended the agreement increasing the royalty rate and device pricing, included a next generation device and provided for payment principally in U.S. dollars rather than Euros. In the fourth quarter of 2014, Ferring purchased the U.S. rights to Teva’s hGH drug Tev-Tropin ® |
Significant Customers and Conce
Significant Customers and Concentrations of Risk | 12 Months Ended |
Dec. 31, 2016 | |
Risks And Uncertainties [Abstract] | |
Significant Customers and Concentrations of Risk | 10. Significant Customers and Concentrations of Risk Revenues by customer location are summarized as follows: For the Years Ended December 31, 2016 2015 2014 United States of America $ 45,531,470 $ 39,228,615 $ 21,409,371 Europe 6,116,865 6,025,899 4,761,684 Other 573,711 403,586 330,610 $ 52,222,046 $ 45,658,100 $ 26,501,665 The following summarizes significant customers comprising 10% or more of total revenue: For the Years Ended December 31, 2016 2015 2014 Teva $ 24,941,371 $ 17,714,823 $ 8,682,384 Ferring 6,282,974 6,116,642 4,760,084 McKesson (1) 7,599,905 6,837,047 3,460,000 LEO Pharma — 6,000,000 3,428,571 (1) Represents estimated revenue, net of deferrals, based on OTREXUP ® |
Legal Proceedings
Legal Proceedings | 12 Months Ended |
Dec. 31, 2016 | |
Commitments And Contingencies Disclosure [Abstract] | |
Legal Proceedings | 11. Legal Proceedings In the first quarter of 2014, Medac Pharma, Inc. (“Medac Pharma”) announced that it submitted a NDA to the FDA for an auto-pen containing methotrexate. On February 28, 2014, Antares filed a complaint against Medac Pharma and medac GmbH, the parent company of Medac Pharma, (medac GmbH, together with Medac Pharma, “Medac”) in the U.S. District Court for the District of Delaware, alleging infringement of two of the Company’s patents for technology regarding an auto injector and an auto injector containing methotrexate. On March 14, 2014, Antares filed a motion for preliminary injunction seeking to enjoin Medac from selling its methotrexate auto-pen product if and when such product is approved for sale in the United States, pending the final resolution of the litigation. On April 18, 2014 an amended complaint was filed asserting four Antares patents, and the motion for preliminary injunction was updated. On July 10, 2014, the District Court denied Antares’ motion for preliminary injunction. Antares filed an appeal of the denial of the motion for preliminary injunction with the U.S. Court of Appeals for the Federal Circuit, and in February 2015, that motion was denied. On March 7, 2014, Medac filed suit against Antares, LEO Pharma, Inc. and its parent company, LEO Pharma A/S (LEO Pharma, Inc. together with LEO Pharma A/S, the “LEO Entities”) in the U.S. District Court for the District of New Jersey, alleging that Antares and the LEO Entities infringe Medac Pharma’s U.S. Patent 8,664,231 (the “231 patent”) that was issued by the U.S. Patent and Trademark Office on March 4, 2014. Under the terms of the promotion and license agreement between the Company and the LEO Entities, the Company agreed to indemnify the LEO Entities from claims that OTREXUP ® In April 2015, Antares, Medac and the LEO Entities entered into a settlement agreement pursuant to which all of the proceedings related to Antares’ and Medac’s respective patents mentioned above and the proceeding pending before the Technical Board of Appeal of the European Patent Office were dismissed. The settlement agreement also provides for a royalty-free cross-license under the patents-named in-the proceedings and their families allowing the manufacture and sale of OTREXUP ® |
Quarterly Financial Data (unaud
Quarterly Financial Data (unaudited) | 12 Months Ended |
Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Data (unaudited) | 1 2 . Quarterly Financial Data (unaudited) First Second Third Fourth 2016: Total revenues $ 12,318,772 $ 12,228,390 $ 13,478,763 $ 14,196,121 Gross profit 5,543,031 4,910,292 5,445,042 7,506,915 Net loss (7,656,110 ) (6,061,463 ) (6,120,983 ) (4,500,248 ) Net loss per common share (1) (0.05 ) (0.04 ) (0.04 ) (0.03 ) Weighted average shares 154,858,079 154,936,096 155,060,811 155,111,435 2015: Total revenues $ 8,348,037 $ 14,420,391 $ 11,085,752 $ 11,803,920 Gross profit 4,673,308 9,712,297 5,985,989 5,828,823 Net loss (6,787,674 ) (1,506,646 ) (5,738,041 ) (6,626,485 ) Net loss per common share (1) (0.05 ) (0.01 ) (0.04 ) (0.04 ) Weighted average shares 131,744,741 144,650,269 154,808,641 154,828,729 (1) Net loss per common share is computed based upon the weighted average number of shares outstanding during each period. Basic and diluted loss per share amounts are identical as the effect of potential common shares is anti-dilutive. |
Summary of Significant Accoun20
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements include the accounts of Antares Pharma, Inc. and its two wholly-owned foreign subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. The Company’s significant accounting estimates relate to the revenue recognition periods for license revenues, OTREXUP ® |
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 by the U.S. parent are in currencies other than the U.S. dollar and are subject to foreign currency exchange rate fluctuations. Foreign currency transaction gains and losses are included in foreign exchange gain (loss) in the consolidated statements of operations. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash consists of demand deposits at commercial banks. The Company also invests in cash equivalents consisting of highly liquid investments in money market funds with original maturities of three months or less. |
Allowance for Doubtful Accounts | Allowance for Doubtful Accounts Trade accounts receivable are stated at the amount the Company expects to collect. The Company maintains allowances for doubtful accounts for estimated losses resulting from the inability of its customers to make required payments. The Company considers the following factors when determining the collectability of specific customer accounts: customer credit-worthiness, past transaction history with the customer, current economic industry trends, and changes in customer payment terms. At December 31, 2016, the Company’s accounts receivable balance is due primarily from Teva and distributors of OTREXUP ® |
Inventories | Inventories Inventories are stated at the lower of cost or market. 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. 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 established reserve for excess, dated or obsolete inventory was $900,000 and $800,000 at December 31, 2016 and 2015, respectively. In 2016, the Company wrote off inventory totaling $650,000 and increased the reserve for excess, dated or obsolete inventory by approximately $750,000. In 2015, the Company wrote off $3,500,000 of inventory and increased the reserve for excess, dated or obsolete inventory by approximately $700,000. |
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. Depreciation expense was $1,326,378, $1,034,057 and $880,400 for the years ended December 31, 2016, 2015 and 2014, respectively. |
Patent Rights | Patent Rights The Company capitalizes the costs of obtaining patent rights when there are projected future cash flows for marketed or partnered products associated with the patent. These capitalized costs are being amortized on a straight-line basis over the shorter of the life of the patent or the estimated useful life of the patent, which typically is over periods ranging from five to fifteen years beginning on the earlier of the date the patent is issued or the first commercial sale of product utilizing such patent rights. The Company periodically reviews capitalized patent costs to identify any amounts to be charged to expense for patents that are no longer being pursued or for which there are no future revenues or cash flows anticipated. The Company capitalizes external legal patent defense costs and costs for pursuing patent infringements when it determines that a successful outcome is probable and will lead to an increase in the value of the patent. The capitalized costs are amortized over the remaining life of the related patent. If changes in the anticipated outcome were to occur that reduce the likelihood of a successful outcome of the entire action to less than probable, the capitalized costs would be charged to expense in the period in which the change is determined. The gross carrying amount and accumulated amortization of patents, which are the only intangible assets of the Company subject to amortization, was $4,659,103 and $2,614,495, respectively at December 31, 2016, and $4,533,439 and $2,098,897, respectively, at December 31, 2015. The Company’s estimated aggregate patent amortization expense for the next five years is approximately $541,000, $541,000, $311,000, $92,000 and $71,000 in 2017, 2018, 2019, 2020 and 2021, respectively. Patent amortization expense for the years ended December 31, 2016, 2015 and 2014 was $534,304, $535,791 and $343,817, respectively, and is recorded in selling, general and administrative expenses in the consolidated statements of operations. In 2015, the Company expensed $31,501 of capitalized patent costs for abandoned patents or patents no longer connected with current products. There was no write-off of patent costs in 2016 and 2014, respectively. |
Impairment of Long-Lived Assets and Intangibles | Impairment of Long-Lived Assets and Intangibles Long-lived assets, 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. Such circumstances could include, but are not limited to: (1) a significant adverse change in legal factors or in business climate, (2) unanticipated competition, (3) an adverse action or assessment by a regulator, or (4) a sustained significant drop in the Company’s stock price. When evaluating whether goodwill is potentially impaired, the Company compares the fair value of the reporting unit to the carrying amount, including goodwill. If the carrying amount is found to be greater, then the Company would determine the implied fair value of goodwill by subtracting the fair value of all the identifiable net assets other than goodwill from the fair value of the reporting unit and record an impairment loss, if any, for the excess of the carrying value of goodwill over the implied fair value. At December 31, 2016, the Company had goodwill with a carrying value of $1,095,355 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, 2016, 2015, and 2014, respectively. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying value of certain of the Company’s financial instruments, including accounts receivable and accounts payable, approximate fair value due to the short-term nature of the instruments. From time to time, the Company invests in U.S. Treasury bills or U.S. Treasury notes that are classified as held-to-maturity because the Company has the positive intent and ability to hold the securities to maturity. The investment securities are carried at amortized cost and fair value is determined by quoted market prices, which is a Level 1 fair value measurement. At December 31, 2015, the fair value of the Company’s short-term investments approximated the carrying values and no short-term investments were held at December 31, 2016. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue from the sale of products, development project milestones, license fees and royalties. Revenue is recognized when all of the following criteria are met: persuasive evidence of the arrangement exists; delivery has occurred and we have no remaining obligations; the fee is fixed or determinable; and collectability is reasonably assured. OTREXUP ® The Company began detailing OTREXUP ® ® ® ® ® The Company recognized $15,145,214, $13,249,715 and $7,309,603 in OTREXUP ® ® The Company will continue to recognize revenue upon the earlier to occur of prescription units dispensed or expiration of the right of return until there has been sufficient history to estimate product returns. When it becomes possible to reasonably estimate product returns, a one-time increase in net revenue will be recorded to recognize revenue previously deferred. In addition, the costs of manufacturing OTREXUP ® Product Sales Allowances The Company recognizes product sales allowances as a reduction of product sales in the same period the related revenue is recognized. Product sales allowances are based on amounts owed or to be claimed on the related sales. These estimates take into consideration the terms of our agreements with customers and third-party payors and the levels of inventory within the distribution channels that may result in future rebates or discounts taken. In certain cases, such as patient support programs, the Company recognizes the cost of patient discounts as a reduction of revenue based on estimated utilization. If actual future results vary, it may be necessary to adjust these estimates, which could have an effect on product revenue in the period of adjustment. Product sales allowances include: Wholesaler Distribution Fees . Distribution fees are paid to certain wholesale distributors based on contractually determined rates. The Company accrues the fee on shipment to the respective wholesale distributors and recognizes the fee as a reduction of revenue in the same period the related revenue is recognized. Prompt Pay Discounts . The Company offers cash discounts to its customers, generally 2% of the sales price, as an incentive for prompt payment. The Company accounts for cash discounts by reducing accounts receivable by the prompt pay discount amount and recognizes the discount as a reduction of revenue in the same period the related revenue is recognized. Chargebacks . The Company provides discounts primarily to authorized users of the Federal Supply Schedule (“FSS”) of the General Services Administration under an FSS contract negotiated by the Department of Veterans Affairs and various organizations under Medicaid contracts and regulations. These entities purchase products from the wholesale distributors at a discounted price, and the wholesale distributors then charge back to the Company the difference between the current wholesale acquisition cost and the price the entity paid for the product. The Company will estimate and accrue chargebacks based on estimated wholesaler inventory levels, current contract prices and historical chargeback activity. Chargebacks are recognized as a reduction of revenue in the same period the related revenue is recognized. Rebates . The Company participates in certain rebate programs, which provide discounted prescriptions to qualified insured patients. Under these rebate programs, the Company will pay a rebate to the third-party administrator of the program, generally two to three months after the quarter in which prescriptions subject to the rebate are filled. The Company estimates and accrues for these rebates based on current contract prices, historical and estimated future percentages of product sold to qualified patients. Rebates are recognized as a reduction of revenue in the same period the related revenue is recognized. Patient Discount Programs. The Company offers discount card programs to patients for OTREXUP ® Sumatriptan Revenue Recognition Under a license, supply and distribution agreement with Teva for an auto-injector product containing sumatriptan, the Company produces devices and assembles final product for shipment to Teva, and Teva is responsible for commercial distribution and sale of the product. The Company is compensated, and recognizes revenue, at cost for shipments of product delivered to Teva. The Company is also entitled to receive 50 percent of the future net profits from commercial sales made by Teva. Given the relatively short time period since product launch and limited historical sales data, management is not currently able to estimate the profit margin the Company expects to receive from commercial sales made by Teva. Therefore, revenue from the profit sharing arrangement is currently recognized in the period following the commercial sale by Teva when amounts become fixed and determinable and payable to the Company, which is within 45 days after the end of each fiscal quarter in which commercial sales are made. In future periods, management may be able to reasonably estimate and recognize revenue from the profit sharing arrangement when product is sold by Teva. Other Revenue Recognition The Company sells its proprietary reusable needle-free injectors and related disposable products to pharmaceutical partners and through medical product distributors. The Company’s reusable injectors and related disposable products are not interchangeable with any competitive products and must be used together. The Company recognizes revenue upon shipment when title transfers. The Company offers no price protection or return rights other than for customary warranty claims. Sales terms and pricing are governed by license and distribution agreements. Revenue arrangements with multiple deliverables are divided into separate units of accounting if certain criteria are met, including whether the deliverable has stand-alone value to the customer, the customer has a general right of return relative to the delivered item and delivery or performance of the undelivered item is probable and substantially within the vendor’s control. Arrangement consideration is allocated at the inception of the arrangement to all deliverables on the basis of their relative selling price. The selling price for each deliverable is determined using: (i) vendor-specific objective evidence of selling price (“VSOE”), if it exists, (ii) third-party evidence of selling price (“TPE”) if VSOE does not exist, and (iii) the Company’s best estimate of the selling price if neither VSOE nor TPE exists. Revenue, excluding variable consideration, is recognized upon completion of deliverables based on the relative selling price of each deliverable that was assigned at inception of the arrangement. Royalty revenue is recognized in the period in which it is earned when the Company has information available to determine the amount; however, the majority of the Company’s royalty revenues are recognized one quarter in arrears as information is typically not available to determine quarterly royalty earnings until royalty statements are received from partners. |
Share-Based Compensation | Share-Based Compensation The Company utilizes share based compensation in the form of stock options, restricted stock units (“RSUs”) and performance-based restricted stock units (“PSUs”). The Company records compensation expense associated with share based awards granted to employees at the fair value of the award on the date of grant. The Company uses the Black-Scholes option valuation model to determine the fair value of stock options. The fair values of RSU and PSU grants containing service or performance conditions are based on the market value of the Company’s Common Stock on the date of grant. The fair value of PSUs containing a market condition are estimated using a Monte Carlo simulation. Pre-vesting forfeitures are estimated in the determination of total stock-based compensation cost based on Company experience. The value of the portion of the award that is ultimately expected to vest is expensed ratably over the requisite service period as compensation expense in the consolidated statement of operations. The determination of fair value of share-based payment awards on the grant date requires significant judgment. Assumptions concerning the Company’s stock price volatility and projected employee exercise behavior over the contractual life of the award can significantly impact the estimated fair value of an award. |
Product Warranty | Product Warranty The Company provides a warranty on its reusable needle-free injector devices. The warranty period on a needle-free injector device is typically 24 months from either the date of retail sale of the device by a dealer or distributor or the date of shipment to a customer if specified by contract. The Company recognizes the estimated cost of warranty obligations at the time the products are shipped based on historical claims incurred by the Company. Actual warranty claim costs could differ from these estimates. At December 31, 2016 and 2015, the Company had $100,000 in warranty liability reserves. |
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 periods presented. Potentially dilutive securities excluded from dilutive loss per share were 11,313,909, 9,480,497 and 7,245,485 at December 31, 2016, 2015 and 2014, respectively. |
Segment Information | Segment Information Operating segments are components of an enterprise for which separate financial information is available and is evaluated regularly by the chief operating decision maker in deciding how to allocate resources and in assessing performance. The Company’s chief operating decision maker currently evaluates the Company’s operations as a whole from a number of different operational perspectives, including but not limited to, on a product-by-product, customer and partner basis. The Company derives all significant revenues from self-administered parenteral pharmaceutical products and technologies, and has a single reportable operating segment of business. Accordingly, the Company does not report more than one segment; nevertheless, management periodically evaluates whether the Company continues to have one single reportable segment of business. |
Going Concern | Going Concern The Company adopted Auditing Standard Update (“ ASU”) No. 2014-15, Presentation of Financial Statements - Going Concern: Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern , which defines management’s responsibility to evaluate whether there is substantial doubt about an organization’s ability to continue as a going concern and to provide related footnote disclosures, if required. As of December 31, 2016, the Company had cash and cash equivalents of $27,714,588 and no debt obligations. Based on management’s evaluation, management concluded there is not substantial doubt about the Company’s ability to meet its obligations within one year from the date the financial statements were issued |
Recent Accounting Pronouncements Not Yet Adopted | Recent Accounting Pronouncements Not Yet Adopted In May 2014, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2014-09, Revenue from Contracts with Customers The Company is in the process of evaluating the impact the adoption of this standard will have on its consolidated financial statements and has performed an initial review of its major contracts with customers. Based on the initial reviews, the Company believes the adoption of the new standard may accelerate the timing of revenue recognition for product sales and development revenue under certain license, development and supply agreements, and will require management to estimate and potentially recognize certain variable revenue streams such as royalties and profit sharing arrangements earlier at an amount it believes will not be subject to significant reversal. The Company anticipates adopting the new revenue recognition standard on the effective date of January 1, 2018 utilizing the modified retrospective method of adoption, under which the cumulative effect of the change is recognized as an adjustment to the opening balance of the accumulated deficit within the consolidated balance sheet, and prior reporting periods are not retrospectively adjusted. No significant changes to business processes or systems are currently expected to be necessary. In July 2015, the FASB issued ASU No. 2015-11, Simplifying the Measurement of Inventory. The new standard changes the measurement principle for inventory from the lower of cost or market to lower of cost and net realizable value. The standard is effective for public entities for annual and interim periods beginning after December 15, 2016 and entities are required to disclose the nature and reason for the change in accounting principle in the first interim and annual period of adoption. The adoption of this standard is not expected to have a significant impact on the consolidated results of operations and financial position of the Company. In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) In March 2016, the FASB issued ASU No. 2016-09, Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting “ In January 2017, the FASB issued ASU 2017-04, Intangibles—Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment |
Composition of Certain Financ21
Composition of Certain Financial Statement Captions (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Summary of Composition Of Certain Financial Statement Captions | December 31, December 31, 2016 2015 Inventories: Raw material $ 142,491 $ 305,149 Work in process 2,429,075 1,539,319 Finished goods 2,755,396 3,879,929 $ 5,326,962 $ 5,724,397 Equipment, molds, furniture and fixtures: Furniture, fixtures and office equipment $ 2,234,222 $ 2,058,146 Production molds and equipment 10,582,575 8,481,005 Molds and tooling in process 10,149,596 8,169,543 Less accumulated depreciation (5,098,981 ) (3,915,610 ) $ 17,867,412 $ 14,793,084 Patent rights: Patent rights $ 4,659,103 $ 4,533,439 Less accumulated amortization (2,614,495 ) (2,098,897 ) $ 2,044,608 $ 2,434,542 Accrued expenses and other liabilities: Accrued employee compensation and benefits $ 2,703,470 $ 3,018,987 OTREXUP ® 1,483,699 751,318 Other liabilities 1,685,677 2,717,727 $ 5,872,846 $ 6,488,032 |
Share Based Compensation (Table
Share Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Stock Option Activity | Stock option activity under the Plan as of and for the three years ended December 31, 2016 is as follows: Weighted Weighted Average Average Remaining Aggregate Number of Exercise Contractual Intrinsic Shares Price ($) Term (Years) Value ($) Outstanding at December 31, 2013 7,697,892 1.89 Granted/Issued 2,596,201 2.89 Exercised (2,124,123 ) 1.21 3,585,453 Cancelled/Forfeited (924,485 ) 3.41 Outstanding at December 31, 2014 7,245,485 2.25 Granted/Issued 2,984,010 2.23 Exercised (20,000 ) 1.54 — Cancelled/Forfeited (728,998 ) 2.92 Outstanding at December 31, 2015 9,480,497 2.19 Granted/Issued 4,029,500 1.14 Exercised (142,493 ) 1.23 121,782 Cancelled/Forfeited (2,053,595 ) 2.13 Outstanding at December 31, 2016 11,313,909 1.84 7.0 7,741,133 Exercisable at December 31, 2016 7,789,081 2.04 6.1 513,003 |
Assumptions Used in Fair Value Measurement of Options Granted | December 31, 2016 2015 2014 Risk-free interest rate 1.3 % 1.3 % 1.6 % Annualized volatility 51.7 % 53.5 % 60.7 % 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, 2013 406,663 3.19 155,724 3.96 Granted 651,980 3.02 325,991 3.02 Vested/settled (87,519 ) 2.03 (51,907 ) 3.96 Forfeited/expired (507,582 ) 3.26 (198,684 ) 3.45 Outstanding at December 31, 2014 463,542 3.08 231,124 3.07 Granted 664,391 2.09 664,391 2.18 Vested/settled — (112,285 ) 2.92 Forfeited/expired (171,755 ) 2.69 (68,402 ) 2.47 Outstanding at December 31, 2015 956,178 2.40 714,828 2.32 Granted 750,500 1.15 750,500 1.12 Vested/settled (16,835 ) 3.96 (264,001 ) 2.41 Forfeited/expired (342,554 ) 2.17 (378,669 ) 1.91 Outstanding at December 31, 2016 1,347,289 1.50 822,658 1.39 |
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: 2016 Award 2015 Award 2014 Award Closing stock price on grant date $ 1.12 $ 2.18 $ 3.09 Performance period starting price $ 1.29 $ 2.52 $ 4.08 Term of award (in years) 2.58 2.59 2.59 Volatility 70.1 % 60.5 % 50.9 % Risk-free interest rate 0.97 % 0.83 % 0.60 % Expected dividend yield 0.00 % 0.00 % 0.00 % Fair value per TSR PSU $ 1.25 $ 1.71 $ 2.64 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Leases [Abstract] | |
Summary of Future Minimum Lease Payments | Future minimum lease payments under operating leases with remaining terms in excess of one year as of December 31, 2016 were as follows: Amount 2017 $ 611,067 2018 622,716 2019 565,955 2020 232,865 2021 238,232 Thereafter 59,896 Total future minimum lease payments $ 2,330,731 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
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: 2016 2015 2014 U.S. $ (24,228,608 ) $ (21,831,232 ) $ (35,359,378 ) Switzerland (10,196 ) 1,347,386 232,663 $ (24,238,804 ) $ (20,483,846 ) $ (35,126,715 ) |
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, 2016, 2015 and 2014 are as follows: 2016 2015 2014 Statutory income tax rate (34.0 )% (34.0 )% (34.0 )% State income taxes (6.8 ) (5.7 ) (3.7 ) Valuation allowance increase 35.9 35.2 37.8 Effect of foreign operations — (1.3 ) (0.2 ) Change in unused net operating loss and credit carryforwards 3.7 2.8 (0.2 ) Nondeductible items 1.6 3.9 0.4 0.4 % 0.9 % 0.1 % |
Summary of Deferred Tax Assets (Liabilities) | Deferred tax assets (liabilities) as of December 31, 2016 and 2015 consist of the following: 2016 2015 Gross deferred tax assets: Net operating loss carryforward – U.S. $ 58,206,000 $ 49,450,000 Net operating loss carryforward – Switzerland 65,000 1,526,000 Research and development tax credit carryforward 5,477,000 4,707,000 Deferred revenue 438,000 301,000 Stock-based compensation 2,678,000 2,201,000 Inventory reserve 364,000 315,000 Compensation accruals 996,000 1,006,000 Other 378,000 241,000 68,602,000 59,747,000 Gross deferred tax liabilities – depreciation and amortization (844,000 ) (753,000 ) Less valuation allowance (67,758,000 ) (58,894,000 ) Net deferred tax asset $ — $ 100,000 |
Significant Customers and Con25
Significant Customers and Concentrations of Risk (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Risks And Uncertainties [Abstract] | |
Summary of Revenues by Customer Location | Revenues by customer location are summarized as follows: For the Years Ended December 31, 2016 2015 2014 United States of America $ 45,531,470 $ 39,228,615 $ 21,409,371 Europe 6,116,865 6,025,899 4,761,684 Other 573,711 403,586 330,610 $ 52,222,046 $ 45,658,100 $ 26,501,665 |
Summary of Significant Customers Comprising 10% or More of Total Revenue | The following summarizes significant customers comprising 10% or more of total revenue: For the Years Ended December 31, 2016 2015 2014 Teva $ 24,941,371 $ 17,714,823 $ 8,682,384 Ferring 6,282,974 6,116,642 4,760,084 McKesson (1) 7,599,905 6,837,047 3,460,000 LEO Pharma — 6,000,000 3,428,571 (1) Represents estimated revenue, net of deferrals, based on OTREXUP ® |
Quarterly Financial Data (una26
Quarterly Financial Data (unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Data | First Second Third Fourth 2016: Total revenues $ 12,318,772 $ 12,228,390 $ 13,478,763 $ 14,196,121 Gross profit 5,543,031 4,910,292 5,445,042 7,506,915 Net loss (7,656,110 ) (6,061,463 ) (6,120,983 ) (4,500,248 ) Net loss per common share (1) (0.05 ) (0.04 ) (0.04 ) (0.03 ) Weighted average shares 154,858,079 154,936,096 155,060,811 155,111,435 2015: Total revenues $ 8,348,037 $ 14,420,391 $ 11,085,752 $ 11,803,920 Gross profit 4,673,308 9,712,297 5,985,989 5,828,823 Net loss (6,787,674 ) (1,506,646 ) (5,738,041 ) (6,626,485 ) Net loss per common share (1) (0.05 ) (0.01 ) (0.04 ) (0.04 ) Weighted average shares 131,744,741 144,650,269 154,808,641 154,828,729 (1) Net loss per common share is computed based upon the weighted average number of shares outstanding during each period. Basic and diluted loss per share amounts are identical as the effect of potential common shares is anti-dilutive. |
Description of Business - Addit
Description of Business - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2016ProductCandidate | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Number of product candidates in advanced stages of development | 5 |
Summary of Significant Accoun28
Summary of Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended | |||
Dec. 31, 2016USD ($)Subsidiaryshares | Dec. 31, 2015USD ($)shares | Dec. 31, 2014USD ($)shares | Dec. 31, 2013USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | ||||
Wholly-owned subsidiaries of Antares Pharma | Subsidiary | 2 | |||
Bad debt expense | $ 0 | $ 0 | $ 37,000 | |
Allowance for doubtful accounts balance | 10,000 | 10,000 | ||
Inventory reserve | 900,000 | 800,000 | ||
Inventory written-off | 650,000 | 3,500,000 | ||
Increase in inventory reserve | 748,378 | 700,000 | 3,550,000 | |
Depreciation expense | 1,326,378 | 1,034,057 | 880,400 | |
Patent rights | 4,659,103 | 4,533,439 | ||
Accumulated amortization of patents | 2,614,495 | 2,098,897 | ||
Aggregate patent amortization expense, 2017 | 541,000 | |||
Aggregate patent amortization expense, 2018 | 541,000 | |||
Aggregate patent amortization expense, 2019 | 311,000 | |||
Aggregate patent amortization expense, 2020 | 92,000 | |||
Aggregate patent amortization expense, 2021 | 71,000 | |||
Amortization expense | 534,304 | 535,791 | 343,817 | |
Patent write off | 0 | 31,501 | 0 | |
Goodwill | 1,095,355 | 1,095,355 | ||
Goodwill impairment loss | 0 | 0 | 0 | |
Short-term investments | 0 | 15,012,225 | ||
Product revenue | $ 40,318,339 | 27,533,042 | $ 13,195,577 | |
Cash discount to incentive for prompt payment | 2.00% | |||
Method used for fair value assumption | Black-Scholes option valuation model | |||
Warranty period of device | 24 months | |||
Warranty liability reserves | $ 100,000 | $ 100,000 | ||
Potentially dilutive securities excluded from dilutive loss per share | shares | 11,313,909 | 9,480,497 | 7,245,485 | |
Cash and cash equivalents | $ 27,714,588 | $ 32,898,676 | $ 34,028,889 | $ 39,067,236 |
Accounting Standards Update 2014-15 [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Cash and cash equivalents | 27,714,588 | |||
Debt obligations | $ 0 | |||
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] | ||||
Product revenue | $ 15,145,214 | 13,249,715 | $ 7,309,603 | |
Deferred revenue balance | $ 1,670,220 | $ 1,064,874 | ||
Minimum [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Estimated useful lives | 3 years | |||
Capitalized cost being amortized over periods | 5 years | |||
Maximum [Member] | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Estimated useful lives | 10 years | |||
Capitalized cost being amortized over periods | 15 years |
Composition of Certain Financ29
Composition of Certain Financial Statement Captions - Summary of Composition of Certain Financial Statement Captions (Detail) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Inventories: | ||
Raw material | $ 142,491 | $ 305,149 |
Work in process | 2,429,075 | 1,539,319 |
Finished goods | 2,755,396 | 3,879,929 |
Inventory, Total | 5,326,962 | 5,724,397 |
Equipment, molds, furniture and fixtures: | ||
Furniture, fixtures and office equipment | 2,234,222 | 2,058,146 |
Production molds and equipment | 10,582,575 | 8,481,005 |
Molds and tooling in process | 10,149,596 | 8,169,543 |
Less accumulated depreciation | (5,098,981) | (3,915,610) |
Equipment, molds, furniture and fixtures, Total | 17,867,412 | 14,793,084 |
Patent rights: | ||
Patent rights | 4,659,103 | 4,533,439 |
Less accumulated amortization | (2,614,495) | (2,098,897) |
Patent rights, Total | 2,044,608 | 2,434,542 |
Accrued expenses and other liabilities: | ||
Accrued employee compensation and benefits | 2,703,470 | 3,018,987 |
Other liabilities | 1,685,677 | 2,717,727 |
Accrued expenses and other liabilities | 5,872,846 | 6,488,032 |
OTREXUP [Member] | ||
Accrued expenses and other liabilities: | ||
OTREXUP® product sales allowances | $ 1,483,699 | $ 751,318 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) | May 11, 2015 | Dec. 31, 2015 | Dec. 31, 2016 | Jun. 02, 2016 | Jun. 01, 2016 |
Stockholders Equity [Line Items] | |||||
Authorized shares of capital stock | 303,000,000 | 203,000,000 | |||
Common stock, par value | $ 0.01 | $ 0.01 | $ 0.01 | ||
Common stock, shares authorized | 200,000,000 | 300,000,000 | 300,000,000 | ||
Proceeds from issuance of common stock, net | $ 42,850,677 | ||||
Underwritten Public Offering [Member] | |||||
Stockholders Equity [Line Items] | |||||
Issuance of common stock, shares | 23,000,000 | ||||
Common stock price per shares | $ 2 | ||||
Proceeds from issuance of common stock, net | $ 42,900,000 |
Share Based Compensation - Addi
Share Based Compensation - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | ||
Jun. 30, 2016 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares withheld to meet employees' minimum statutory income tax obligation | 73,888 | 39,665 | 38,768 | |
Payments for the employees' minimum statutory income tax obligation | $ 83,631 | $ 87,770 | $ 154,397 | |
Warrant [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Warrants outstanding | 0 | 0 | ||
Proceeds from warrant exercised | $ 545,115 | |||
Issuance of shares of common stock Warrants | 545,100 | |||
Warrants exercised per share | $ 1 | |||
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 | 9,400,000 | |||
Minimum [Member] | Amended and Restated 2008 Equity Compensation Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 1 year | |||
Stock Options [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Unrecognized compensation cost related to nonvested outstanding stock awards | $ 2,067,000 | |||
Weighted average period expected to be recognized | 1 year 10 months 24 days | |||
Recognized compensation cost related to shares of stock granted | $ 2,039,000 | $ 2,883,000 | $ 2,060,000 | |
Per share weighted average fair value of options granted | $ 0.57 | $ 1.13 | $ 1.64 | |
Proceeds from the issuance of stock options | $ 101,092 | $ 30,800 | $ 2,564,987 | |
Exercise of options, shares | 102,776 | 20,000 | 2,124,123 | |
Shares withheld to meet employees' minimum statutory income tax obligation | 39,717 | |||
Stock Options [Member] | Long Term Incentive Program [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 3 years | |||
Contractual term of options granted | 10 years | |||
Share based compensation award percentage | 34.00% | 34.00% | 25.00% | |
Stock Options [Member] | Amended and Restated 2008 Equity Compensation Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 3 years | |||
Contractual term of options granted | 10 years | |||
Restricted Stock Units [Member] | Long Term Incentive Program [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 3 years | |||
Recognized compensation cost related to shares of stock granted | $ 413,000 | $ 526,000 | $ 212,000 | |
Share based compensation award percentage | 33.00% | 33.00% | 25.00% | |
Performance Stock Units [Member] | Long Term Incentive Program [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Recognized compensation cost related to shares of stock granted | $ 68,000 | $ 250,000 | ||
Share based compensation award percentage | 33.00% | 33.00% | 50.00% | |
Reduction in recognized stock unit awards compensation expenses | $ 3,000 | |||
Performance Stock Units [Member] | Minimum [Member] | Long Term Incentive Program [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 3 years | |||
Share based compensation award percentage | 0.00% | |||
Performance Stock Units [Member] | Maximum [Member] | Long Term Incentive Program [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Vesting period | 5 years | |||
Share based compensation award percentage | 150.00% |
Share Based Compensation - Stoc
Share Based Compensation - Stock Option Activity (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Stockholders Equity Note [Abstract] | |||
Number of Shares Outstanding, Beginning Balance | 9,480,497 | 7,245,485 | 7,697,892 |
Number of Shares Granted/Issued | 4,029,500 | 2,984,010 | 2,596,201 |
Number of Shares Exercised | (142,493) | (20,000) | (2,124,123) |
Number of Shares Cancelled/Forfeited | (2,053,595) | (728,998) | (924,485) |
Number of Shares Outstanding, Ending Balance | 11,313,909 | 9,480,497 | 7,245,485 |
Number of Shares Exercisable, Ending Balance | 7,789,081 | ||
Weighted Average Exercise Price Outstanding, Beginning Balance | $ 2.19 | $ 2.25 | $ 1.89 |
Weighted Average Exercise Price Granted/Issued | 1.14 | 2.23 | 2.89 |
Weighted Average Exercise Price Exercised | 1.23 | 1.54 | 1.21 |
Weighted Average Exercise Price Cancelled/Forfeited | 2.13 | 2.92 | 3.41 |
Weighted Average Exercise Price Outstanding, Ending Balance | 1.84 | $ 2.19 | $ 2.25 |
Weighted Average Exercise Price Exercisable, Ending Balance | $ 2.04 | ||
Weighted Average Remaining Contractual Term (Years) Outstanding, Ending Balance | 7 years | ||
Weighted Average Remaining Contractual Term (Years) Exercisable, Ending Balance | 6 years 1 month 6 days | ||
Aggregate Intrinsic Value, Exercised | $ 121,782 | $ 3,585,453 | |
Aggregate Intrinsic Value Outstanding, Ending Balance | 7,741,133 | ||
Aggregate Intrinsic Value Exercisable, Ending Balance | $ 513,003 |
Share Based Compensation - Assu
Share Based Compensation - Assumptions Used in Fair Value Measurement of Options Granted (Detail) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Stockholders Equity Note [Abstract] | |||
Risk-free interest rate | 1.30% | 1.30% | 1.60% |
Annualized volatility | 51.70% | 53.50% | 60.70% |
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, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Performance Stock Units [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of Shares, Beginning Balance | 956,178 | 463,542 | 406,663 |
Number of Shares, Granted | 750,500 | 664,391 | 651,980 |
Number of Shares, Vested/settled | (16,835) | (87,519) | |
Number of Shares, Forfeited/expired | (342,554) | (171,755) | (507,582) |
Number of Shares, Ending Balance | 1,347,289 | 956,178 | 463,542 |
Weighted Average Grant Date Fair Value, Beginning Balance | $ 2.40 | $ 3.08 | $ 3.19 |
Weighted Average Grant Date Fair Value, Granted | 1.15 | 2.09 | 3.02 |
Weighted Average Grant Date Fair Value, Vested/settled | 3.96 | 2.03 | |
Weighted Average Grant Date Fair Value, Forfeited/expired | 2.17 | 2.69 | 3.26 |
Weighted Average Grant Date Fair Value, Ending Balance | $ 1.50 | $ 2.40 | $ 3.08 |
Restricted Stock Units [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of Shares, Beginning Balance | 714,828 | 231,124 | 155,724 |
Number of Shares, Granted | 750,500 | 664,391 | 325,991 |
Number of Shares, Vested/settled | (264,001) | (112,285) | (51,907) |
Number of Shares, Forfeited/expired | (378,669) | (68,402) | (198,684) |
Number of Shares, Ending Balance | 822,658 | 714,828 | 231,124 |
Weighted Average Grant Date Fair Value, Beginning Balance | $ 2.32 | $ 3.07 | $ 3.96 |
Weighted Average Grant Date Fair Value, Granted | 1.12 | 2.18 | 3.02 |
Weighted Average Grant Date Fair Value, Vested/settled | 2.41 | 2.92 | 3.96 |
Weighted Average Grant Date Fair Value, Forfeited/expired | 1.91 | 2.47 | 3.45 |
Weighted Average Grant Date Fair Value, Ending Balance | $ 1.39 | $ 2.32 | $ 3.07 |
Share Based Compensation - Fair
Share Based Compensation - Fair Value of PSUs Granted Determined Using Monte Carlo Simulation (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Term of award (in years) | 6 years | 6 years | 6 years |
Volatility | 51.70% | 53.50% | 60.70% |
Risk-free interest rate | 1.30% | 1.30% | 1.60% |
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 | $ 1.12 | $ 2.18 | $ 3.09 |
Performance period starting price | $ 1.29 | $ 2.52 | $ 4.08 |
Term of award (in years) | 2 years 6 months 29 days | 2 years 7 months 2 days | 2 years 7 months 2 days |
Volatility | 70.10% | 60.50% | 50.90% |
Risk-free interest rate | 0.97% | 0.83% | 0.60% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Fair value per TSR PSU | $ 1.25 | $ 1.71 | $ 2.64 |
Employee 401(k) Savings Plan -
Employee 401(k) Savings Plan - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Postemployment Benefits [Abstract] | |||
Maximum employee plan contribution percentage of compensation | 50.00% | ||
Company plan contributions | $ 519,000 | $ 392,000 | $ 373,000 |
Leases - Additional Information
Leases - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Leases [Abstract] | |||
Rent expense | $ 679,693 | $ 672,210 | $ 611,818 |
Leases - Summary of Future Mini
Leases - Summary of Future Minimum Lease Payments (Detail) | Dec. 31, 2016USD ($) |
Operating Leases Future Minimum Payments Due [Abstract] | |
2,017 | $ 611,067 |
2,018 | 622,716 |
2,019 | 565,955 |
2,020 | 232,865 |
2,021 | 238,232 |
Thereafter | 59,896 |
Total future minimum lease payments | $ 2,330,731 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Operating Loss Carryforwards [Line Items] | |||
Period of incurred losses for both book and tax purposes | 3 years | ||
Valuation allowance for deferred tax assets | $ 67,758,000 | $ 58,894,000 | |
Increased and decreased total valuation allowance | 8,864,000 | 7,853,000 | |
Deferred tax assets, net of valuation allowances | 0 | 100,000 | |
Recognized tax expense | 100,000 | 175,000 | $ 25,000 |
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 | $ 156,343,000 | ||
Expiring net operating loss carryforward amount | 5,075,000 | ||
Research credit carryforward | $ 5,051,000 | ||
U.S Federal Tax [Member] | Minimum [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforward expiration year | 2,018 | ||
U.S Federal Tax [Member] | Maximum [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforward expiration year | 2,036 | ||
Foreign Tax Authority [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carry forward | $ 437,000 | ||
Net operating loss carryforward expiration year | 2,018 | ||
Switzerland [Member] | |||
Operating Loss Carryforwards [Line Items] | |||
Net operating loss carryforwards were used to fully offset book and tax income | $ 13,000 | 1,127,000 | 177,000 |
Benefit of deferred tax assets | 175,000 | 25,000 | |
Taxable income from operations | $ 13,000 | 1,127,000 | 177,000 |
Recognized tax expense | $ 175,000 | $ 25,000 |
Income Taxes - Schedule of Inco
Income Taxes - Schedule of Income (Loss) before Income Tax Domestic and Foreign (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income (Loss) from Continuing Operations before Equity Method Investments, Income Taxes, Extraordinary Items, Noncontrolling Interest [Abstract] | |||
Income (loss) before income taxes, US | $ (24,228,608) | $ (21,831,232) | $ (35,359,378) |
Income (loss) before income taxes, Switzerland | (10,196) | 1,347,386 | 232,663 |
Net loss before income taxes | $ (24,238,804) | $ (20,483,846) | $ (35,126,715) |
Income Taxes - Summary of Effec
Income Taxes - Summary of Effective Tax Rates Differ from Statutory Income Tax Rates (Detail) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Effective Income Tax Rate Reconciliation, Percent [Abstract] | |||
Statutory income tax rate | (34.00%) | (34.00%) | (34.00%) |
State income taxes | (6.80%) | (5.70%) | (3.70%) |
Valuation allowance increase | 35.90% | 35.20% | 37.80% |
Effect of foreign operations | (1.30%) | (0.20%) | |
Change in unused net operating loss and credit carryforwards | 3.70% | 2.80% | (0.20%) |
Nondeductible items | 1.60% | 3.90% | 0.40% |
Effective income tax rate, Total | 0.40% | 0.90% | 0.10% |
Income Taxes - Summary of Defer
Income Taxes - Summary of Deferred Tax Assets (Liabilities) (Detail) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Gross deferred tax assets: | ||
Net operating loss carryforward – U.S. | $ 58,206,000 | $ 49,450,000 |
Net operating loss carryforward – Switzerland | 65,000 | 1,526,000 |
Research and development tax credit carryforward | 5,477,000 | 4,707,000 |
Deferred revenue | 438,000 | 301,000 |
Stock-based compensation | 2,678,000 | 2,201,000 |
Inventory reserve | 364,000 | 315,000 |
Compensation accruals | 996,000 | 1,006,000 |
Other | 378,000 | 241,000 |
Deferred tax asset, Total | 68,602,000 | 59,747,000 |
Gross deferred tax liabilities – depreciation and amortization | (844,000) | (753,000) |
Less valuation allowance | (67,758,000) | (58,894,000) |
Net deferred tax asset | $ 0 | $ 100,000 |
Revenue Arrangements - Addition
Revenue Arrangements - Additional Information (Detail) | 1 Months Ended | 12 Months Ended | ||||
Nov. 30, 2013USD ($) | Dec. 31, 2007Device | Jul. 31, 2006 | Dec. 31, 2016 | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | |
Deferred Revenue Arrangement [Line Items] | ||||||
Revenue recognition period of deliverables | 35 months | |||||
LEO Pharma [Member] | ||||||
Deferred Revenue Arrangement [Line Items] | ||||||
Non refundable upfront payment | $ 5,000,000 | |||||
Revenue recognized | $ 6,000,000 | $ 3,429,000 | ||||
Performance Obligations [Member] | ||||||
Deferred Revenue Arrangement [Line Items] | ||||||
Milestone payment received | 5,000,000 | |||||
Sales Revenue, Net [Member] | ||||||
Deferred Revenue Arrangement [Line Items] | ||||||
Milestone payment receivable | $ 10,000,000 | |||||
Teva License Supply and Distribution Agreement [Member] | ||||||
Deferred Revenue Arrangement [Line Items] | ||||||
Term of the agreement | 7 years | |||||
Period for automatic renewals | 2 years | 1 year | ||||
Number of disposable pen injector devices | Device | 2 | |||||
Agreement expiration month and year | 2017-12 | |||||
Device or product filed period | 12 months | 12 months | ||||
Teva License Supply and Distribution Agreement [Member] | Parent Company [Member] | ||||||
Deferred Revenue Arrangement [Line Items] | ||||||
Percentage of profit distribution | 50.00% | |||||
Teva License Supply and Distribution Agreement [Member] | Teva [Member] | ||||||
Deferred Revenue Arrangement [Line Items] | ||||||
Percentage of profit distribution | 50.00% | |||||
Ferring Agreements [Member] | ||||||
Deferred Revenue Arrangement [Line Items] | ||||||
Period for automatic renewals | 1 year | |||||
Milestone payment received | $ 1,000,000 | |||||
Period of terminated by either party | 6 months |
Significant Customers and Con44
Significant Customers and Concentrations of Risk - Summary of Revenues by Customer Location (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Concentration Risk [Line Items] | |||||||||||
Total revenues | $ 14,196,121 | $ 13,478,763 | $ 12,228,390 | $ 12,318,772 | $ 11,803,920 | $ 11,085,752 | $ 14,420,391 | $ 8,348,037 | $ 52,222,046 | $ 45,658,100 | $ 26,501,665 |
United States of America [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Total revenues | 45,531,470 | 39,228,615 | 21,409,371 | ||||||||
Europe [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Total revenues | 6,116,865 | 6,025,899 | 4,761,684 | ||||||||
Other [Member] | |||||||||||
Concentration Risk [Line Items] | |||||||||||
Total revenues | $ 573,711 | $ 403,586 | $ 330,610 |
Significant Customers and Con45
Significant Customers and Concentrations of Risk - Summary of Significant Customers Comprising 10% or More of Total Revenue (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | ||||||||||
Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | ||
Concentration Risk [Line Items] | ||||||||||||
Total revenues | $ 14,196,121 | $ 13,478,763 | $ 12,228,390 | $ 12,318,772 | $ 11,803,920 | $ 11,085,752 | $ 14,420,391 | $ 8,348,037 | $ 52,222,046 | $ 45,658,100 | $ 26,501,665 | |
Teva [Member] | ||||||||||||
Concentration Risk [Line Items] | ||||||||||||
Total revenues | 24,941,371 | 17,714,823 | 8,682,384 | |||||||||
Ferring [Member] | ||||||||||||
Concentration Risk [Line Items] | ||||||||||||
Total revenues | 6,282,974 | 6,116,642 | 4,760,084 | |||||||||
McKesson [Member] | ||||||||||||
Concentration Risk [Line Items] | ||||||||||||
Total revenues | [1] | $ 7,599,905 | 6,837,047 | 3,460,000 | ||||||||
LEO Pharma [Member] | ||||||||||||
Concentration Risk [Line Items] | ||||||||||||
Total revenues | $ 6,000,000 | $ 3,428,571 | ||||||||||
[1] | Represents estimated revenue, net of deferrals, based on OTREXUP® shipments to the distributor. |
Legal Proceedings - Additional
Legal Proceedings - Additional Information (Detail) | Dec. 31, 2016Patent |
Commitments And Contingencies Disclosure [Abstract] | |
Number of patents | 2 |
Quarterly Financial Data (una47
Quarterly Financial Data (unaudited) - Quarterly Financial Data (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Selected Quarterly Financial Information [Abstract] | |||||||||||
Total revenues | $ 14,196,121 | $ 13,478,763 | $ 12,228,390 | $ 12,318,772 | $ 11,803,920 | $ 11,085,752 | $ 14,420,391 | $ 8,348,037 | $ 52,222,046 | $ 45,658,100 | $ 26,501,665 |
Gross profit | 7,506,915 | 5,445,042 | 4,910,292 | 5,543,031 | 5,828,823 | 5,985,989 | 9,712,297 | 4,673,308 | 23,405,280 | 26,200,417 | 15,264,970 |
Net loss | $ (4,500,248) | $ (6,120,983) | $ (6,061,463) | $ (7,656,110) | $ (6,626,485) | $ (5,738,041) | $ (1,506,646) | $ (6,787,674) | $ (24,338,804) | $ (20,658,846) | $ (35,151,715) |
Net loss per common share | $ (0.03) | $ (0.04) | $ (0.04) | $ (0.05) | $ (0.04) | $ (0.04) | $ (0.01) | $ (0.05) | |||
Weighted average shares | 155,111,435 | 155,060,811 | 154,936,096 | 154,858,079 | 154,828,729 | 154,808,641 | 144,650,269 | 131,744,741 |