Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2015 | Nov. 01, 2015 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2015 | |
Document Fiscal Year Focus | 2,015 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | ATRS | |
Entity Registrant Name | ANTARES PHARMA, INC. | |
Entity Central Index Key | 1,016,169 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 154,828,512 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Sep. 30, 2015 | Dec. 31, 2014 |
Current Assets: | ||
Cash | $ 35,880,958 | $ 34,028,889 |
Short-term investments | 12,008,939 | 6,002,438 |
Accounts receivable | 6,558,074 | 3,510,051 |
Inventories | 5,657,336 | 5,859,924 |
Deferred costs | 519,376 | 1,913,921 |
Prepaid expenses and other current assets | 2,023,907 | 2,322,464 |
Total current assets | 62,648,590 | 53,637,687 |
Equipment, molds, furniture and fixtures, net | 13,831,713 | 10,828,741 |
Patent rights, net | 2,551,015 | 2,885,024 |
Goodwill | 1,095,355 | 1,095,355 |
Long-term investments | 3,006,531 | 0 |
Other assets | 326,024 | 325,955 |
Total Assets | 83,459,228 | 68,772,762 |
Current Liabilities: | ||
Accounts payable | 2,392,929 | 10,071,504 |
Accrued expenses and other liabilities | 5,745,440 | 5,635,559 |
Deferred revenue | 1,980,710 | 8,520,517 |
Total current liabilities | 10,119,079 | 24,227,580 |
Deferred revenue – long term | 719,400 | 3,349,026 |
Total liabilities | $ 10,838,479 | $ 27,576,606 |
Stockholders’ Equity: | ||
Preferred Stock: $0.01 par, authorized 3,000,000 shares, none outstanding | ||
Common Stock: $0.01 par; authorized 200,000,000 shares; 154,828,512 and 131,743,365 issued and outstanding at September 30, 2015 and December 31, 2014, respectively | $ 1,548,285 | $ 1,317,433 |
Additional paid-in capital | 294,252,003 | 249,032,066 |
Accumulated deficit | (222,480,017) | (208,447,656) |
Accumulated other comprehensive loss | (699,522) | (705,687) |
Total Stockholders' Equity | 72,620,749 | 41,196,156 |
Total Liabilities and Stockholders’ Equity | $ 83,459,228 | $ 68,772,762 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2015 | Dec. 31, 2014 |
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 | 200,000,000 | 200,000,000 |
Common Stock, shares issued | 154,828,512 | 131,743,365 |
Common Stock, shares outstanding | 154,828,512 | 131,743,365 |
Consolidated Statements of Oper
Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Revenue: | ||||
Product sales | $ 8,027,029 | $ 3,559,579 | $ 18,490,193 | $ 8,724,884 |
Development revenue | 2,608,336 | 1,744,735 | 8,024,184 | 4,954,285 |
Licensing revenue | 42,960 | 926,955 | 6,112,341 | 2,783,434 |
Royalties | 407,427 | 339,312 | 1,227,462 | 1,636,958 |
Total revenue | 11,085,752 | 6,570,581 | 33,854,180 | 18,099,561 |
Cost of revenue: | ||||
Cost of product sales | 3,265,983 | 2,158,266 | 7,763,734 | 5,021,896 |
Cost of development revenue | 1,833,780 | 349,100 | 5,718,852 | 792,295 |
Total cost of revenue | 5,099,763 | 2,507,366 | 13,482,586 | 5,814,191 |
Gross profit | 5,985,989 | 4,063,215 | 20,371,594 | 12,285,370 |
Operating expenses: | ||||
Research and development | 5,142,387 | 4,426,730 | 14,089,100 | 12,903,304 |
Selling, general and administrative | 6,611,169 | 6,810,089 | 20,253,489 | 24,455,167 |
Total operating expenses | 11,753,556 | 11,236,819 | 34,342,589 | 37,358,471 |
Operating loss | (5,767,567) | (7,173,604) | (13,970,995) | (25,073,101) |
Other income (expense) | 29,526 | (12,837) | (61,366) | (5,670) |
Net loss | $ (5,738,041) | $ (7,186,441) | $ (14,032,361) | $ (25,078,771) |
Basic and diluted net loss per common share | $ (0.04) | $ (0.05) | $ (0.10) | $ (0.19) |
Basic and diluted weighted average common shares outstanding | 154,808,641 | 130,771,380 | 143,819,033 | 130,163,929 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Statement Of Income And Comprehensive Income [Abstract] | ||||
Net loss | $ (5,738,041) | $ (7,186,441) | $ (14,032,361) | $ (25,078,771) |
Foreign currency translation adjustment | (22,044) | (32,114) | 6,165 | (32,204) |
Comprehensive loss | $ (5,760,085) | $ (7,218,555) | $ (14,026,196) | $ (25,110,975) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Cash flows from operating activities: | ||
Net loss | $ (14,032,361) | $ (25,078,771) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,169,745 | 873,158 |
Loss on disposal of equipment | 167,097 | |
Stock-based compensation expense | 2,649,062 | 1,898,241 |
Amortization of premiums and discounts | 7,070 | 19,259 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (3,045,011) | (1,237,907) |
Inventories | 202,588 | (1,531,910) |
Prepaid expenses and other current assets | 316,315 | 776,389 |
Deferred costs | 1,394,545 | (1,313,724) |
Other assets | 276 | |
Accounts payable | (5,742,113) | (220,962) |
Accrued expenses and other current liabilities | 236,434 | 605,211 |
Deferred revenue | (9,173,966) | 4,733,129 |
Net cash used in operating activities | (25,850,595) | (20,477,611) |
Cash flows from investing activities: | ||
Purchases of equipment, molds, furniture and fixtures | (5,013,012) | (2,829,738) |
Additions to patent rights | (1,008,363) | (461,943) |
Proceeds from maturities of investment securities | 6,000,000 | 21,000,000 |
Purchases of investment securities | (15,037,675) | |
Net cash provided by (used in) investing activities | (15,059,050) | 17,708,319 |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock, net | 42,850,677 | |
Proceeds from exercise of stock options and warrants | 2,908,540 | |
Taxes paid related to net share settlement of equity awards | (87,770) | (154,397) |
Net cash provided by financing activities | 42,762,907 | 2,754,143 |
Effect of exchange rate changes on cash | (1,193) | (1,255) |
Net increase (decrease) in cash | 1,852,069 | (16,404) |
Cash: | ||
Beginning of period | 34,028,889 | 39,067,236 |
End of period | 35,880,958 | 39,050,832 |
Supplemental disclosure of non-cash investing activities: | ||
Purchases of equipment, molds, furniture and fixtures recorded in accounts payable and accrued expenses | $ 42,758 | 526,137 |
Additions to patent rights recorded in accounts payable and accrued expenses | $ 1,423,227 |
Description of Business
Description of Business | 9 Months Ended |
Sep. 30, 2015 | |
Accounting Policies [Abstract] | |
Description of Business | 1. Description of Business Antares Pharma, Inc. (“Antares” or the “Company”) is an emerging, specialty pharmaceutical company focusing on the development and commercialization of self-administered parenteral pharmaceutical products and technologies. The Company has multiple internal product development programs as well as numerous partnership arrangements with several industry leading pharmaceutical companies. The Company has formed significant strategic alliances with Teva Pharmaceutical Industries, Ltd. (“Teva”), Ferring Pharmaceuticals Inc. and Ferring B.V. (together “Ferring”), and JCR Pharmaceuticals Co., Ltd. (“JCR”). Through these relationships, the Company develops and applies its drug delivery systems in collaborations with the pharmaceutical partners to enhance the partners' drug compounds and delivery methods. The Company develops and manufactures, for itself and with its partners, novel, pressure-assisted injector devices, with and without needles, which allow patients to self-inject drugs. It makes a reusable, needle-free spring action injection device which is marketed through its partners for use with human growth hormone (hGH). The Company has also developed variations of the needle-free injector by adding a small shielded needle to a pre-filled, single-use disposable injector, called the VIBEX® pressure assisted auto injection system. This system is an alternative to the needle-free system for use with injectable drugs in unit dose containers and is suitable for branded and generic injectables. Additionally, the Company developed a disposable multi-dose pen injector for use with standard cartridges, and has a portfolio of gel-based products which are commercialized through various partners. In February 2014, the Company launched its product OTREXUP™ (methotrexate) injection, which is the first subcutaneous methotrexate for once weekly self-administration with an easy-to-use, single dose, disposable auto injector approved by the U.S. Food and Drug Administration (“FDA”). OTREXUP™ is indicated for adults with severe active rheumatoid arthritis (“RA”), children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis. To date, Antares has received FDA approval for dosage strengths of 7.5 mg, 10 mg, 15 mg, 20 mg and 25 mg of OTREXUP™. The Company has other products at various stages of development and approval. Antares is developing VIBEX® Sumatriptan for the acute treatment of migraines and has begun commercial scale tooling and mold fabrication in anticipation of a potential approval and launch. The Company is currently conducting clinical studies of VIBEX® QuickShot ® |
Basis of Presentation and Signi
Basis of Presentation and Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2015 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Significant Accounting Policies | 2. Basis of Presentation and Significant Accounting Policies The accompanying unaudited consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the U.S. for interim financial information and with the instructions to Form 10-Q and Article 10 of the Securities and Exchange Commission's Regulation S-X. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the U.S. for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation have been included. The accompanying consolidated financial statements and notes thereto should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2014. Operating results for the three and nine months ended September 30, 2015 are not necessarily indicative of the results that may be expected for the year ending December 31, 2015. Certain prior year amounts have been reclassified in the consolidated financial statements to conform to the current year presentation. These reclassifications were made to present selling, general and administrative expenses in one line in the consolidated statements of operations. In prior years, sales and marketing expenses and general and administrative expenses were presented in separate lines. These reclassifications have no effect on previously reported net income or total operating expenses. Investments All short-term and long-term investments are U.S. Treasury bills or U.S. Treasury notes that are classified as held-to-maturity because of the Company’s positive intent and ability to hold the securities to maturity. The securities are carried at their amortized cost and the fair value of all securities is determined by quoted market prices. At September 30, 2015 and December 31, 2014, the Company’s short-term investments had a carrying value of $12,008,939 and $6,002,438, respectively. As of September 30, 2015, the Company had long-term investments with a carrying value of $3,006,531, and held no long-term investments as of December 31, 2014. The carrying value of the Company’s short-term and long-term investments as of September 30, 2015 and December 31, 2014 approximated fair value. 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, assembly, warehousing and distribution operations are outsourced to third-parties 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 an analysis of inventory on hand compared to forecasts of future sales. Inventories consist of the following: September 30, December 31, 2015 2014 Inventories: Raw material $ 236,924 $ 461,396 Work in process 3,171,074 3,896,837 Finished goods 2,249,338 1,501,691 $ 5,657,336 $ 5,859,924 Capitalized Patent Costs 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. As of September 30, 2015 and December 31, 2014, approximately $1,800,000 in external legal patent defense costs were capitalized within patent rights, net. Product Revenue In February 2014, the Company began detailing OTREXUP™ to health care professionals in the U.S. and began shipping to wholesale pharmaceutical distributors, subject to rights of return within a period beginning six months prior to, and ending 12 months following, product expiration. Given the limited sales history of OTREXUP™, the Company currently cannot reliably estimate expected returns of the product at the time of shipment. Accordingly, recognition of revenue is deferred on product shipments of OTREXUP™ until the right of return no longer exists, which occurs at the earlier of the time OTREXUP™ units are dispensed through patient prescriptions or expiration of the right of return. Units dispensed are generally not subject to return, except in the rare cases where the product malfunctions or the product is damaged in transit. Patient prescriptions dispensed are estimated using third-party market prescription data. These third-party sources poll pharmacies, hospitals, mail order and other retail outlets for OTREXUP™ prescriptions and project this sample on a national level. If patient prescriptions dispensed for a given period are underestimated or overestimated, adjustments to revenue may be necessary in future periods. The Company recognized $3,592,779 and $9,943,182 in OTREXUP™ product revenue for the three and nine months ended September 30, 2015, respectively, as compared to $2,606,973 and $4,491,288 for the three and nine months ended September 30, 2014, which is presented net of product allowances for estimated wholesaler discounts, prompt pay discounts, chargebacks, rebates and patient discount programs. The Company had deferred revenue balances of $954,401 and $1,061,947 at September 30, 2015 and December 31, 2014, respectively, for OTREXUP™ product shipments, which is net of product sales allowances. The Company will continue to recognize revenue upon the earlier to occur of prescription units dispensed or expiration of the right of return until it can reliably estimate product returns, at which time the Company will record a one-time increase in net revenue related to the recognition of revenue previously deferred. In addition, the costs of manufacturing OTREXUP™ associated with the deferred revenue are recorded as deferred costs, which are included in inventory, until such time as the related deferred revenue is recognized. 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 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 estimates and accrues 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 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™ in which patients receive discounts on their prescriptions that are reimbursed by the Company. The Company estimates the total amount that will be redeemed based on historical redemption experience and on levels of inventory in the distribution and retail channels and recognizes the discount as a reduction of revenue in the same period the related revenue is recognized. |
Licensing Agreements and Contra
Licensing Agreements and Contractual Arrangements | 9 Months Ended |
Sep. 30, 2015 | |
Deferred Revenue Disclosure [Abstract] | |
Licensing Agreements and Contractual Arrangements | 3. Licensing Agreements and Contractual Arrangements The Company has entered into multiple license agreements for its devices with Teva. The Company’s development projects in collaboration with Teva include VIBEX® Epinephrine, an exenatide multi-dose pen, and another undisclosed multi-dose pen. In December 2014, Teva submitted the final amendment to the VIBEX® Epinephrine ANDA, and FDA accepted Teva’s filing of an ANDA in October 2014 for exenatide, formerly referred to as Teva “Pen 2”. Antares is also developing VIBEX® Sumatriptan for the acute treatment of migraines which, if approved will be distributed by Teva. The Company received a complete response letter from the FDA regarding its Abbreviated New Drug Application (“ANDA”) for VIBEX® Sumatriptan, providing revisions to labelling and citing minor deficiencies. The Company submitted its response to the FDA in March, 2015, and received a second complete response letter from the FDA primarily requesting additional labeling revisions, to which it responded in July 2015. Commercial scale tooling and mold fabrication has begun in anticipation of potential approval and launch. The Company also makes a reusable, needle-free, spring-action injector device, which is marketed for use with human growth hormone, hGH, through licenses to its pharmaceutical partners Ferring and JCR, which generates product sales and royalties. Ferring commercializes the Company’s needle-free injection system with their 4 mg and 10 mg hGH formulations marketed as Zomajet ® ® ® ® ® ™ ® ™ Antares has a portfolio of gel-based products which are marketed through licensing agreements. Actavis plc (“Actavis”) is currently marketing Gelnique ® ® LEO Pharma Promotion and License Agreement In November 2013, the Company entered into a promotion and license agreement with LEO Pharma (“LEO”), under which the Company granted LEO the exclusive right to promote OTREXUP TM Effective June 23, 2015, the agreement with LEO was terminated and the Company regained the exclusive U.S. marketing rights to OTREXUP™. As a result, the Company recognized the remaining unamortized balance of the deferred revenues related to this arrangement in the second quarter of 2015. Deferred revenue in connection with this agreement was $6,000,000 at December 31, 2014. The Company recognized zero and $857,143 in licensing revenue for the three month periods ended September 30, 2015 and 2014, respectively, and $6,000,000 and $2,571,429 in licensing revenue for the nine month periods ended September 30, 2015 and 2014, respectively in connection with this agreement and its subsequent termination. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2015 | |
Equity [Abstract] | |
Stockholders' Equity | 4. Stockholders’ Equity 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 $42.9 million after deducting underwriting discounts, commissions and offering expenses paid by the Company. The Company intends to use the net proceeds from the offering for general corporate purposes including business development, in-licensing and acquisitions. Equity Compensation Plan The Company’s 2008 Equity Compensation Plan (the “Plan”) allows for grants in the form of incentive stock options, nonqualified stock options, stock units, stock awards, stock appreciation rights, and other stock-based awards. All of the Company’s officers, directors, employees, consultants and advisors are eligible to receive grants under the Plan. The maximum number of shares authorized for issuance under the Plan is 21,000,000 and the maximum number of shares of stock that may be granted to any one participant during a calendar year is 1,000,000 shares. Options to purchase shares of common stock are granted at exercise prices not less than 100% of fair market value on the dates of grant. The term of each option is ten years and the options typically vest in quarterly installments over a three-year period. As of September 30, 2015, the Plan had 852,808 shares available for grant. Stock Options A summary of stock option activity under the Plan as of September 30, 2015, and the changes during the nine months then ended is as follows: Weighted Weighted Average Average Remaining Aggregate Number of Exercise Contractual Intrinsic Shares Price ($) Term (Years) Value ($) Outstanding at December 31, 2014 7,245,485 2.25 Granted 2,959,010 2.23 Exercised — — — Cancelled/Forfeited (633,416 ) 2.91 Outstanding at September 30, 2015 9,571,079 2.20 6.9 1,581,795 Exercisable at September 30, 2015 6,188,948 2.07 5.6 1,581,795 The per share weighted average fair values of all options granted during the first nine months of 2015 and 2014 were estimated as $1.13 and $3.08, 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 price. The weighted average expected life is based on both historical and anticipated employee behavior. September 30, 2015 2014 Risk-free interest rate 1.3 % 1.7 % Annualized volatility 53.5 % 62.0 % Weighted average expected life, in years 6.0 6.0 Expected dividend yield 0.0 % 0.0 % There were no stock option exercises in the first nine months of 2015. In the first nine months of 2014, 1,991,728 stock options with a weighted average exercise price of $1.19 were exercised which generated proceeds of $2,363,425 to the Company. Total recognized compensation expense for stock options was $2,177,067 and $1,451,031 for the first nine months of 2015 and 2014, respectively, and totaled $766,062 and $643,304 for the three month periods ended September 30, 2015 and 2014, respectively. As of September 30, 2015, there was $3,678,779 of total unrecognized compensation cost related to nonvested outstanding stock options that is expected to be recognized over a weighted average period of approximately 2.01 years. Long Term Incentive Program (LTIP) The Company’s Board of Directors has approved a long term incentive program (“LTIP”) for the benefit of the Company’s senior executives. Pursuant to the LTIP, the Company’s senior executives have been awarded stock options, restricted stock units (“RSU”) and performance stock units (“PSU”) with targeted values based on values granted by the Company’s peer group. The stock options have a ten-year term, have an exercise price equal to the closing price of the Company’s common stock on the date of grant, vest in quarterly installments over three years, were otherwise granted on the same standard terms and conditions as other stock options granted pursuant to the Plan and are included in the stock options table above. The RSUs vest in three equal annual installments. The PSU awards made to the senior executives vest and convert into shares of the Company’s common stock based on the Company’s attainment of certain performance goals over a performance period of three years. The performance stock unit awards and restricted stock unit awards granted under the long term incentive program are summarized in the following table: Performance Stock Units Restricted Stock Units Number of Shares Weighted Average Date Fair Value ($) Number of Shares Weighted Average Grant Date Fair Value ($) Outstanding at December 31, 2014 463,542 3.08 231,124 3.07 Granted 664,391 2.09 664,391 2.18 Vested/settled — (112,285 ) 3.24 Forfeited/expired (167,583 ) 2.65 (68,402 ) 2.47 Outstanding at September 30, 2015 960,350 2.41 714,828 2.32 In 2015 and 2014, 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 performance period, which performance period is January 1, 2014 to December 31, 2016 for the 2014 award and January 1, 2015 to December 31, 2017 for the 2015 award. 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 in May 2015 and 2014 was determined using a Monte Carlo simulation and utilized the following inputs and assumptions: 2015 Award 2014 Award Closing stock price on grant date $ 2.18 $ 3.09 Performance period starting price $ 2.57 $ 4.08 Term of award (in years) 2.59 2.59 Volatility 60.45 % 50.87 % Risk-free interest rate 0.83 % 0.61 % Expected dividend yield 0.00 % 0.00 % Fair value per TSR PSU $ 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 performance period. Total compensation expense recognized in connection with PSU awards totaled $89,911 in the first nine months of 2015. The Company recognized a net expense reduction of $55,463 in the first nine months of 2014 due to the forfeiture of PSU awards in connection with the departure of senior executives. Compensation expense recognized in the first nine months of 2015 and 2014 in connection with the RSUs was $382,084 and $146,866, respectively. Shares issued in connection with PSU and RSU awards that vested in the first nine months of 2015 and 2014 were net-share settled such that the Company withheld shares with a 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 to satisfy tax obligations were 39,665 and 38,768 in the nine months ended September 30, 2015 and 2014, respectively, and were based on the fair 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 $87,770 and $154,397 in the nine months ended September 30, 2015 and 2014, respectively, and are reflected as a financing activity within the consolidated statements of cash flows. These net-share settlements had the effect of share repurchases by the Company as they 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 In the first nine months of 2014, the Company received proceeds of $545,115 from the exercise of 545,100 warrants. There were no warrants outstanding at September 30, 2015 or December 31, 2014. Stock Awards At times, the Company makes discretionary grants of its common stock to members of management and other employees in lieu of cash bonus awards or in recognition of special achievements. There were no discretionary grants of common stock in the first nine months of 2015. In the first nine months of 2014, there were 150,000 shares of common stock granted to members of executive management as bonus compensation for achievements in 2013. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2015 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 5. Net Loss Per Share Basic loss per common share is computed by dividing net loss applicable to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted loss per common share reflects the potential dilution from the exercise or conversion of securities into common stock. Potentially dilutive stock options excluded from dilutive loss per share because their effect was anti-dilutive totaled 9,571,079 and 7,107,190 at September 30, 2015 and 2014, respectively. |
Industry Segment and Operations
Industry Segment and Operations by Geographic Areas | 9 Months Ended |
Sep. 30, 2015 | |
Segment Reporting [Abstract] | |
Industry Segment and Operations by Geographic Areas | 6. Industry Segment and Operations by Geographic Areas The Company has one operating segment, drug delivery, which includes the development of injection devices and injection based pharmaceutical products as well as transdermal gel products. Revenues by customer location are summarized as follows: Three Months Ended Nine Months Ended September 30, September 30, 2015 2014 2015 2014 United States of America $ 9,740,486 $ 5,823,339 $ 30,055,925 $ 14,310,806 Europe 1,309,731 735,613 3,609,798 3,565,616 Other 35,535 11,629 188,457 223,139 $ 11,085,752 $ 6,570,581 $ 33,854,180 $ 18,099,561 Significant customers comprising 10% or more of total revenue are as follows: Three Months Ended Nine Months Ended September 30, September 30, 2015 2014 2015 2014 Teva $ 5,097,912 $ 1,779,595 $ 12,227,129 $ 6,084,408 LEO Pharma — 857,143 6,000,000 2,571,429 McKesson (1) 2,105,422 1,489,699 5,440,323 1,916,957 Ferring 1,309,731 734,013 3,609,798 3,564,021 (1) Represents estimated revenue based on OTREXUP™ shipments, a portion of which has not been recognized as revenue but is recorded in deferred revenue at the end of each period as discussed in Note 2 to the Consolidated Financial Statements. |
Legal Proceedings
Legal Proceedings | 9 Months Ended |
Sep. 30, 2015 | |
Commitments And Contingencies Disclosure [Abstract] | |
Legal Proceedings | 7. Legal Proceedings In the first quarter of 2014, medac Pharma, Inc. (“Medac Pharma”) announced that it submitted a New Drug Application (“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. In 2014, a total of approximately $1,800,000 in legal costs in connection with this suit was capitalized. 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™ infringes the intellectual property rights of any third party. On July 1, 2014, Antares filed a petition with the Patent Trial and Appeal Board (the “PTAB”) of the U.S. Patent and Trademark Office seeking an inter partes review of the 231 patent, and in January 2015, the PTAB decided to institute review of the 231 patent. Legal costs in connection with this suit and the inter partes review were expensed as incurred. In April 2015, Antares, Medac and the LEO Entites 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™ (methotrexate) injection and RASUVO™ in and for the U.S. As a result, the $1,800,000 million of capitalized legal patent defense costs will continue to be amortized over the estimated useful life of the patents. |
Recent Accounting Pronouncement
Recent Accounting Pronouncements | 9 Months Ended |
Sep. 30, 2015 | |
New Accounting Pronouncements And Changes In Accounting Principles [Abstract] | |
Recent Accounting Pronouncements | 8. Recent Accounting Pronouncements In July 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (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. Early adoption is permitted. 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 Company is currently evaluating the impact of this standard on its consolidated results of operations and financial position. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (“ASU No. 2014-09”). This guidance requires an entity to recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The standard creates a five-step model that requires a company to: identify customer contracts, identify the separate performance obligations, determine the transaction price, allocate the transaction price to the separate performance obligations and recognize revenue when each performance obligation is satisfied. This guidance also requires an entity to disclose sufficient information to enable users of financial statements to understand the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. Qualitative and quantitative information is required about: · Contracts with customers—including revenue and impairments recognized, disaggregation of revenue and information about contract balances and performance obligations (including the transaction price allocated to the remaining performance obligations). · Significant judgments and changes in judgments—determining the timing of satisfaction of performance obligations (over time or at a point in time), and determining the transaction price and amounts allocated to performance obligations. · Certain assets—assets recognized from the costs to obtain or fulfill a contract. In August 2015, the FASB issued ASU 2015-14 which defers the effective date of ASU No. 2014-09 by one year to annual reporting periods beginning after December 15, 2017, including interim periods within that year. The standard allows for either full retrospective adoption, where the standard is applied to all periods presented, or modified retrospective adoption where the standard is applied only to the most current period presented in the financial statements. Early adoption of ASU 2014-09 is permitted but not before the original effective date (annual periods beginning after December 15, 2016). The Company is currently evaluating the impact of the adoption of this standard on its consolidated results of operations and financial position. |
Subsequent Event
Subsequent Event | 9 Months Ended |
Sep. 30, 2015 | |
Subsequent Events [Abstract] | |
Subsequent Event | 9 . Subsequent Event On October 5, 2015, the Company received a written notice of termination of its licensing agreement (the “Agreement”) with Pfizer Consumer Healthcare (“Pfizer”) for one of its drug delivery technologies. Pfizer informed the Company that the product Pfizer was developing failed to meet pre-specified endpoints in a clinical study. The Agreement will terminate on November 5, 2015. |
Basis of Presentation and Sig16
Basis of Presentation and Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2015 | |
Accounting Policies [Abstract] | |
Investments | Investments All short-term and long-term investments are U.S. Treasury bills or U.S. Treasury notes that are classified as held-to-maturity because of the Company’s positive intent and ability to hold the securities to maturity. The securities are carried at their amortized cost and the fair value of all securities is determined by quoted market prices. At September 30, 2015 and December 31, 2014, the Company’s short-term investments had a carrying value of $12,008,939 and $6,002,438, respectively. As of September 30, 2015, the Company had long-term investments with a carrying value of $3,006,531, and held no long-term investments as of December 31, 2014. The carrying value of the Company’s short-term and long-term investments as of September 30, 2015 and December 31, 2014 approximated fair value. |
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, assembly, warehousing and distribution operations are outsourced to third-parties 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 an analysis of inventory on hand compared to forecasts of future sales. Inventories consist of the following: September 30, December 31, 2015 2014 Inventories: Raw material $ 236,924 $ 461,396 Work in process 3,171,074 3,896,837 Finished goods 2,249,338 1,501,691 $ 5,657,336 $ 5,859,924 |
Capitalized Patent Costs | Capitalized Patent Costs 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. As of September 30, 2015 and December 31, 2014, approximately $1,800,000 in external legal patent defense costs were capitalized within patent rights, net. |
Product Revenue | Product Revenue In February 2014, the Company began detailing OTREXUP™ to health care professionals in the U.S. and began shipping to wholesale pharmaceutical distributors, subject to rights of return within a period beginning six months prior to, and ending 12 months following, product expiration. Given the limited sales history of OTREXUP™, the Company currently cannot reliably estimate expected returns of the product at the time of shipment. Accordingly, recognition of revenue is deferred on product shipments of OTREXUP™ until the right of return no longer exists, which occurs at the earlier of the time OTREXUP™ units are dispensed through patient prescriptions or expiration of the right of return. Units dispensed are generally not subject to return, except in the rare cases where the product malfunctions or the product is damaged in transit. Patient prescriptions dispensed are estimated using third-party market prescription data. These third-party sources poll pharmacies, hospitals, mail order and other retail outlets for OTREXUP™ prescriptions and project this sample on a national level. If patient prescriptions dispensed for a given period are underestimated or overestimated, adjustments to revenue may be necessary in future periods. The Company recognized $3,592,779 and $9,943,182 in OTREXUP™ product revenue for the three and nine months ended September 30, 2015, respectively, as compared to $2,606,973 and $4,491,288 for the three and nine months ended September 30, 2014, which is presented net of product allowances for estimated wholesaler discounts, prompt pay discounts, chargebacks, rebates and patient discount programs. The Company had deferred revenue balances of $954,401 and $1,061,947 at September 30, 2015 and December 31, 2014, respectively, for OTREXUP™ product shipments, which is net of product sales allowances. The Company will continue to recognize revenue upon the earlier to occur of prescription units dispensed or expiration of the right of return until it can reliably estimate product returns, at which time the Company will record a one-time increase in net revenue related to the recognition of revenue previously deferred. In addition, the costs of manufacturing OTREXUP™ associated with the deferred revenue are recorded as deferred costs, which are included in inventory, until such time as the related deferred revenue is recognized. |
Product Sales Allowances | 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 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 estimates and accrues 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 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™ in which patients receive discounts on their prescriptions that are reimbursed by the Company. The Company estimates the total amount that will be redeemed based on historical redemption experience and on levels of inventory in the distribution and retail channels and recognizes the discount as a reduction of revenue in the same period the related revenue is recognized. |
Recent Accounting Pronouncements | In July 2015, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (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. Early adoption is permitted. 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 Company is currently evaluating the impact of this standard on its consolidated results of operations and financial position. In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (“ASU No. 2014-09”). This guidance requires an entity to recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The standard creates a five-step model that requires a company to: identify customer contracts, identify the separate performance obligations, determine the transaction price, allocate the transaction price to the separate performance obligations and recognize revenue when each performance obligation is satisfied. This guidance also requires an entity to disclose sufficient information to enable users of financial statements to understand the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers. Qualitative and quantitative information is required about: · Contracts with customers—including revenue and impairments recognized, disaggregation of revenue and information about contract balances and performance obligations (including the transaction price allocated to the remaining performance obligations). · Significant judgments and changes in judgments—determining the timing of satisfaction of performance obligations (over time or at a point in time), and determining the transaction price and amounts allocated to performance obligations. · Certain assets—assets recognized from the costs to obtain or fulfill a contract. In August 2015, the FASB issued ASU 2015-14 which defers the effective date of ASU No. 2014-09 by one year to annual reporting periods beginning after December 15, 2017, including interim periods within that year. The standard allows for either full retrospective adoption, where the standard is applied to all periods presented, or modified retrospective adoption where the standard is applied only to the most current period presented in the financial statements. Early adoption of ASU 2014-09 is permitted but not before the original effective date (annual periods beginning after December 15, 2016). The Company is currently evaluating the impact of the adoption of this standard on its consolidated results of operations and financial position. |
Basis of Presentation and Sig17
Basis of Presentation and Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Accounting Policies [Abstract] | |
Inventories | Inventories consist of the following: September 30, December 31, 2015 2014 Inventories: Raw material $ 236,924 $ 461,396 Work in process 3,171,074 3,896,837 Finished goods 2,249,338 1,501,691 $ 5,657,336 $ 5,859,924 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Summary of Stock Option Activity | A summary of stock option activity under the Plan as of September 30, 2015, and the changes during the nine months then ended is as follows: Weighted Weighted Average Average Remaining Aggregate Number of Exercise Contractual Intrinsic Shares Price ($) Term (Years) Value ($) Outstanding at December 31, 2014 7,245,485 2.25 Granted 2,959,010 2.23 Exercised — — — Cancelled/Forfeited (633,416 ) 2.91 Outstanding at September 30, 2015 9,571,079 2.20 6.9 1,581,795 Exercisable at September 30, 2015 6,188,948 2.07 5.6 1,581,795 |
Assumptions Used in Fair Value Measurement of Options Granted | September 30, 2015 2014 Risk-free interest rate 1.3 % 1.7 % Annualized volatility 53.5 % 62.0 % Weighted average expected life, in years 6.0 6.0 Expected dividend yield 0.0 % 0.0 % |
Schedule of Performance Stock Unit Awards and Restricted Stock Granted Under Long Term Incentive Program | The performance stock unit awards and restricted stock unit awards granted under the long term incentive program are summarized in the following table: Performance Stock Units Restricted Stock Units Number of Shares Weighted Average Date Fair Value ($) Number of Shares Weighted Average Grant Date Fair Value ($) Outstanding at December 31, 2014 463,542 3.08 231,124 3.07 Granted 664,391 2.09 664,391 2.18 Vested/settled — (112,285 ) 3.24 Forfeited/expired (167,583 ) 2.65 (68,402 ) 2.47 Outstanding at September 30, 2015 960,350 2.41 714,828 2.32 |
Performance Stock Units [Member] | |
Assumptions Used in Fair Value Measurement of Options Granted | The fair values of the TSR PSUs granted in May 2015 and 2014 was determined using a Monte Carlo simulation and utilized the following inputs and assumptions: 2015 Award 2014 Award Closing stock price on grant date $ 2.18 $ 3.09 Performance period starting price $ 2.57 $ 4.08 Term of award (in years) 2.59 2.59 Volatility 60.45 % 50.87 % Risk-free interest rate 0.83 % 0.61 % Expected dividend yield 0.00 % 0.00 % Fair value per TSR PSU $ 1.71 $ 2.64 |
Industry Segment and Operatio19
Industry Segment and Operations by Geographic Areas (Tables) | 9 Months Ended |
Sep. 30, 2015 | |
Segment Reporting [Abstract] | |
Summary of Revenues by Customer Location | Revenues by customer location are summarized as follows: Three Months Ended Nine Months Ended September 30, September 30, 2015 2014 2015 2014 United States of America $ 9,740,486 $ 5,823,339 $ 30,055,925 $ 14,310,806 Europe 1,309,731 735,613 3,609,798 3,565,616 Other 35,535 11,629 188,457 223,139 $ 11,085,752 $ 6,570,581 $ 33,854,180 $ 18,099,561 |
Summary of Significant Customers Comprising 10% or More of Total Revenue | Significant customers comprising 10% or more of total revenue are as follows: Three Months Ended Nine Months Ended September 30, September 30, 2015 2014 2015 2014 Teva $ 5,097,912 $ 1,779,595 $ 12,227,129 $ 6,084,408 LEO Pharma — 857,143 6,000,000 2,571,429 McKesson (1) 2,105,422 1,489,699 5,440,323 1,916,957 Ferring 1,309,731 734,013 3,609,798 3,564,021 (1) Represents estimated revenue based on OTREXUP™ shipments, a portion of which has not been recognized as revenue but is recorded in deferred revenue at the end of each period as discussed in Note 2 to the Consolidated Financial Statements. |
Basis of Presentation and Sig20
Basis of Presentation and Significant Accounting Policies - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | Dec. 31, 2014 | |
Summary Of Significant Accounting Policies [Line Items] | |||||
Short-term investments | $ 12,008,939 | $ 12,008,939 | $ 6,002,438 | ||
Long-term investments | 3,006,531 | 3,006,531 | 0 | ||
Capitalized legal patent cost | $ 1,800,000 | $ 1,800,000 | 1,800,000 | ||
Cash discount to incentive for prompt payment | 2.00% | 2.00% | |||
OTREXUP [Member] | |||||
Summary Of Significant Accounting Policies [Line Items] | |||||
Product revenue | $ 3,592,779 | $ 2,606,973 | $ 9,943,182 | $ 4,491,288 | |
Deferred revenue balance | $ 954,401 | $ 954,401 | $ 1,061,947 |
Basis of Presentation and Sig21
Basis of Presentation and Significant Accounting Policies - Inventories (Detail) - USD ($) | Sep. 30, 2015 | Dec. 31, 2014 |
Inventories: | ||
Raw material | $ 236,924 | $ 461,396 |
Work in process | 3,171,074 | 3,896,837 |
Finished goods | 2,249,338 | 1,501,691 |
Inventory, Total | $ 5,657,336 | $ 5,859,924 |
License Agreements and Contract
License Agreements and Contractual Arrangements - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Nov. 30, 2013 | Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | Dec. 31, 2014 | |
Deferred Revenue Arrangement [Line Items] | ||||||
Licensing revenue | $ 42,960 | $ 926,955 | $ 6,112,341 | $ 2,783,434 | ||
LEO Pharma [Member] | ||||||
Deferred Revenue Arrangement [Line Items] | ||||||
Non refundable upfront payment | $ 5,000,000 | |||||
Deferred revenue | $ 10,000,000 | |||||
Amortization of deferred revenue to licensing revenue period | 3 years | |||||
Deferred revenue | $ 6,000,000 | |||||
Licensing revenue | $ 0 | $ 857,143 | $ 6,000,000 | $ 2,571,429 | ||
Performance Obligations [Member] | ||||||
Deferred Revenue Arrangement [Line Items] | ||||||
Milestone payment received | $ 5,000,000 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) | May. 11, 2015 | Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | Dec. 31, 2014 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Proceeds from issuance of common stock, net | $ 42,850,677 | |||||
Contractual term of options granted | 10 years | |||||
Number of Shares Exercised | 0 | 1,991,728 | ||||
Weighted Average Exercise Price Exercised | $ 0 | $ 1.19 | ||||
Shares withheld to meet employees' minimum statutory income tax obligation | 39,665 | 38,768 | ||||
Payments for the employees' minimum statutory income tax obligation | $ 87,770 | $ 154,397 | ||||
Warrant [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Proceeds from warrant exercised | $ 545,115 | |||||
Warrants exercised | 545,100 | |||||
Warrants outstanding | 0 | 0 | 0 | |||
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 | 21,000,000 | 21,000,000 | ||||
Maximum number of shares of stock granted to one participant | 1,000,000 | |||||
Minimum percentage of exercise price | 100.00% | |||||
Shares available for grant under the plan | 852,808 | 852,808 | ||||
Stock Options [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Per share weighted average fair value of options granted | $ 1.13 | $ 3.08 | ||||
Proceeds from the exercise of stock options | $ 2,363,425 | |||||
Recognized compensation cost related to shares of stock granted | $ 766,062 | $ 643,304 | $ 2,177,067 | 1,451,031 | ||
Unrecognized compensation cost related to nonvested outstanding stock awards | $ 3,678,779 | $ 3,678,779 | ||||
Weighted average period expected to be recognized | 2 years 4 days | |||||
Restricted Stock [Member] | Long Term Incentive Program [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period | 3 years | |||||
Performance Stock Units [Member] | Long Term Incentive Program [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period | 3 years | |||||
Compensation costs related to awards | $ 89,911 | 55,463 | ||||
Performance Stock Units [Member] | Long Term Incentive Program [Member] | Minimum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share based compensation award percentage | 0.00% | |||||
Performance Stock Units [Member] | Long Term Incentive Program [Member] | Maximum [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share based compensation award percentage | 150.00% | |||||
Restricted Stock Units [Member] | Long Term Incentive Program [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Compensation costs related to awards | $ 382,084 | $ 146,866 | ||||
Discretionary Shares [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share based payment discretionary awards shares granted | 0 | 150,000 | ||||
Underwritten Public Offering [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [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 | |||||
Employees [Member] | Equity Compensation Plan [Member] | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Contractual term of options granted | 10 years | |||||
Vesting period | 3 years |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Stock Option Activity (Detail) - USD ($) | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Stockholders Equity Note [Abstract] | ||
Number of Shares Outstanding, Beginning | 7,245,485 | |
Number of Shares Granted | 2,959,010 | |
Number of Shares Exercised | 0 | 1,991,728 |
Number of Shares Cancelled/Forfeited | (633,416) | |
Number of Shares Outstanding, Ending | 9,571,079 | |
Number of Shares Exercisable, Ending | 6,188,948 | |
Weighted Average Exercise Price Outstanding, Beginning Balance | $ 2.25 | |
Weighted Average Exercise Price Granted/Issued | 2.23 | |
Weighted Average Exercise Price Exercised | 0 | $ 1.19 |
Weighted Average Exercise Price Cancelled/Forfeited | 2.91 | |
Weighted Average Exercise Price Outstanding, Ending Balance | 2.20 | |
Weighted Average Exercise Price Exercisable, Ending Balance | $ 2.07 | |
Weighted Average Remaining Contractual Term Outstanding, Ending | 6 years 10 months 24 days | |
Weighted Average Remaining Contractual Term Exercisable, Ending | 5 years 7 months 6 days | |
Aggregate Intrinsic Value Outstanding, Ending | $ 1,581,795 | |
Aggregate Intrinsic Value Exercisable, Ending | $ 1,581,795 |
Stockholders' Equity - Assumpti
Stockholders' Equity - Assumptions Used in Fair Value Measurement of Options Granted (Detail) | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Stockholders Equity Note [Abstract] | ||
Risk-free interest rate | 1.30% | 1.70% |
Annualized volatility | 53.50% | 62.00% |
Weighted average expected life, in years | 6 years | 6 years |
Expected dividend yield | 0.00% | 0.00% |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Performance Stock Unit Awards and Restricted Stock Granted Under Long Term Incentive Program (Detail) | 9 Months Ended |
Sep. 30, 2015$ / sharesshares | |
Performance Stock Units [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares, Beginning Balance | shares | 463,542 |
Number of Shares, Granted | shares | 664,391 |
Number of Shares, Forfeited/expired | shares | (167,583) |
Number of Shares, Ending Balance | shares | 960,350 |
Weighted Average Fair Value, Beginning Balance | $ 3.08 |
Weighted Average Fair Value, Granted | 2.09 |
Weighted Average Fair Value, Forfeited/expired | 2.65 |
Weighted Average Fair Value, Ending Balance | $ 2.41 |
Restricted Stock Units [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares, Beginning Balance | shares | 231,124 |
Number of Shares, Granted | shares | 664,391 |
Number of Shares, Vested/settled | shares | (112,285) |
Number of Shares, Forfeited/expired | shares | (68,402) |
Number of Shares, Ending Balance | shares | 714,828 |
Weighted Average Fair Value, Beginning Balance | $ 3.07 |
Weighted Average Fair Value, Granted | 2.18 |
Weighted Average Fair Value, Vested/settled | 3.24 |
Weighted Average Fair Value, Forfeited/expired | 2.47 |
Weighted Average Fair Value, Ending Balance | $ 2.32 |
Stockholders' Equity - Fair Val
Stockholders' Equity - Fair Value of PSUs Granted Determined Using Monte Carlo Simulation (Detail) - $ / shares | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Term of award (in years) | 6 years | 6 years |
Volatility | 53.50% | 62.00% |
Risk-free interest rate | 1.30% | 1.70% |
Expected dividend yield | 0.00% | 0.00% |
Performance Stock Units [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Closing stock price on grant date | $ 2.18 | $ 3.09 |
Performance period starting price | $ 2.57 | $ 4.08 |
Term of award (in years) | 2 years 7 months 2 days | 2 years 7 months 2 days |
Volatility | 60.45% | 50.87% |
Risk-free interest rate | 0.83% | 0.61% |
Expected dividend yield | 0.00% | 0.00% |
Fair value per TSR PSU | $ 1.71 | $ 2.64 |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Detail) - shares | 9 Months Ended | |
Sep. 30, 2015 | Sep. 30, 2014 | |
Earnings Per Share [Abstract] | ||
Dilutive stock options excluded from dilutive loss per share | 9,571,079 | 7,107,190 |
Industry Segment and Operatio29
Industry Segment and Operations by Geographic Areas - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2015Segment | |
Segment Reporting Information [Line Items] | |
Number of operating segment | 1 |
Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | |
Segment Reporting Information [Line Items] | |
Total revenue | 10.00% |
Industry Segment and Operatio30
Industry Segment and Operations by Geographic Areas - Revenues By Customer Location (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Segment Reporting Information [Line Items] | ||||
Total revenues | $ 11,085,752 | $ 6,570,581 | $ 33,854,180 | $ 18,099,561 |
U.S [Member] | ||||
Segment Reporting Information [Line Items] | ||||
Total revenues | 9,740,486 | 5,823,339 | 30,055,925 | 14,310,806 |
Europe [Member] | ||||
Segment Reporting Information [Line Items] | ||||
Total revenues | 1,309,731 | 735,613 | 3,609,798 | 3,565,616 |
Other [Member] | ||||
Segment Reporting Information [Line Items] | ||||
Total revenues | $ 35,535 | $ 11,629 | $ 188,457 | $ 223,139 |
Industry Segment and Operatio31
Industry Segment and Operations by Geographic Areas - Summary of Significant Customers Comprising 10% or More of Total Revenue (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2015 | Sep. 30, 2014 | Sep. 30, 2015 | Sep. 30, 2014 | |
Segment Reporting Information [Line Items] | ||||
Total revenues | $ 11,085,752 | $ 6,570,581 | $ 33,854,180 | $ 18,099,561 |
Teva [Member] | ||||
Segment Reporting Information [Line Items] | ||||
Total revenues | 5,097,912 | 1,779,595 | 12,227,129 | 6,084,408 |
LEO Pharma [Member] | ||||
Segment Reporting Information [Line Items] | ||||
Total revenues | 857,143 | 6,000,000 | 2,571,429 | |
McKesson [Member] | ||||
Segment Reporting Information [Line Items] | ||||
Total revenues | 2,105,422 | 1,489,699 | 5,440,323 | 1,916,957 |
Ferring [Member] | ||||
Segment Reporting Information [Line Items] | ||||
Total revenues | $ 1,309,731 | $ 734,013 | $ 3,609,798 | $ 3,564,021 |
Legal Proceedings - Additional
Legal Proceedings - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2015USD ($)Patent | |
Commitments And Contingencies Disclosure [Abstract] | |
Legal costs capitalized as patent costs | $ | $ 1,800,000 |
Number of patents | 2 |
Subsequent Event - Additional I
Subsequent Event - Additional Information (Detail) - Subsequent Event [Member] - Pfizer License Agreement [Member] | Oct. 05, 2015Agreement |
Subsequent Event [Line Items] | |
Number of agreements under termination notice | 1 |
Date of agreement termination | Nov. 5, 2015 |