Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2016 | Aug. 05, 2016 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2016 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q2 | |
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 | 155,058,159 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
Current Assets: | ||
Cash | $ 27,559,208 | $ 32,898,676 |
Short-term investments | 9,004,427 | 15,012,225 |
Accounts receivable | 10,295,347 | 7,952,478 |
Inventories | 7,458,933 | 5,724,397 |
Deferred costs | 2,141,280 | 1,199,217 |
Prepaid expenses and other current assets | 2,716,391 | 3,274,254 |
Total current assets | 59,175,586 | 66,061,247 |
Equipment, molds, furniture and fixtures, net | 17,356,620 | 14,793,084 |
Patent rights, net | 2,224,881 | 2,434,542 |
Goodwill | 1,095,355 | 1,095,355 |
Other assets | 153,762 | 177,943 |
Total Assets | 80,006,204 | 84,562,171 |
Current Liabilities: | ||
Accounts payable | 10,825,215 | 5,187,703 |
Accrued expenses and other liabilities | 6,958,452 | 6,488,032 |
Deferred revenue | 6,494,770 | 5,143,825 |
Total current liabilities | 24,278,437 | 16,819,560 |
Deferred revenue – long term | 1,200,000 | 700,000 |
Total liabilities | 25,478,437 | 17,519,560 |
Stockholders’ Equity: | ||
Preferred Stock: $0.01 par, authorized 3,000,000 shares, none outstanding | ||
Common Stock: $0.01 par; 300,000,000 shares authorized; 155,058,159 and 154,848,512 issued and outstanding at June 30, 2016 and December 31, 2015, respectively | 1,550,582 | 1,548,485 |
Additional paid-in capital | 296,503,498 | 295,292,414 |
Accumulated deficit | (242,824,075) | (229,106,502) |
Accumulated other comprehensive loss | (702,238) | (691,786) |
Total Stockholders' Equity | 54,527,767 | 67,042,611 |
Total Liabilities and Stockholders’ Equity | $ 80,006,204 | $ 84,562,171 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 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 | |
Common Stock, shares issued | 155,058,159 | 154,848,512 |
Common Stock, shares outstanding | 155,058,159 | 154,848,512 |
Consolidated Statements of Oper
Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Revenue: | ||||
Product sales | $ 8,690,002 | $ 5,840,034 | $ 19,531,049 | $ 10,463,164 |
Development revenue | 3,267,397 | 3,027,445 | 4,365,771 | 5,415,848 |
Licensing revenue | 38,721 | 5,186,372 | 89,422 | 6,069,381 |
Royalties | 232,270 | 366,540 | 560,920 | 820,035 |
Total revenue | 12,228,390 | 14,420,391 | 24,547,162 | 22,768,428 |
Cost of revenue: | ||||
Cost of product sales | 5,216,527 | 2,540,178 | 11,464,083 | 4,497,751 |
Cost of development revenue | 2,101,571 | 2,167,916 | 2,629,756 | 3,885,072 |
Total cost of revenue | 7,318,098 | 4,708,094 | 14,093,839 | 8,382,823 |
Gross profit | 4,910,292 | 9,712,297 | 10,453,323 | 14,385,605 |
Operating expenses: | ||||
Research and development | 3,948,020 | 4,568,732 | 9,596,049 | 8,946,713 |
Selling, general and administrative | 7,014,520 | 6,605,030 | 14,617,698 | 13,642,320 |
Total operating expenses | 10,962,540 | 11,173,762 | 24,213,747 | 22,589,033 |
Operating loss | (6,052,248) | (1,461,465) | (13,760,424) | (8,203,428) |
Other income (expense) | (9,215) | (45,181) | 42,851 | (90,892) |
Net loss | $ (6,061,463) | $ (1,506,646) | $ (13,717,573) | $ (8,294,320) |
Basic and diluted net loss per common share | $ (0.04) | $ (0.01) | $ (0.09) | $ (0.06) |
Basic and diluted weighted average common shares outstanding | 154,936,096 | 144,650,269 | 154,897,089 | 138,233,155 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Statement Of Income And Comprehensive Income [Abstract] | ||||
Net loss | $ (6,061,463) | $ (1,506,646) | $ (13,717,573) | $ (8,294,320) |
Foreign currency translation adjustment | (5,755) | 16,145 | (10,452) | 28,209 |
Comprehensive loss | $ (6,067,218) | $ (1,490,501) | $ (13,728,025) | $ (8,266,111) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Cash flows from operating activities: | ||
Net loss | $ (13,717,573) | $ (8,294,320) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 1,277,277 | 1,650,918 |
Depreciation and amortization | 891,388 | 768,931 |
Loss on disposal of equipment | 17,785 | 167,097 |
Amortization of premiums and discounts | 7,798 | 3,824 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (2,358,302) | (2,932,698) |
Inventories | (1,734,536) | 394,356 |
Prepaid expenses and other assets | 582,241 | (508,362) |
Deferred costs | (942,063) | 969,988 |
Accounts payable | 5,073,875 | (4,052,526) |
Accrued expenses and other current liabilities | 369,693 | 76,220 |
Deferred revenue | 1,849,291 | (8,106,486) |
Net cash used in operating activities | (8,683,126) | (19,863,058) |
Cash flows from investing activities: | ||
Purchases of equipment, molds, furniture and fixtures | (2,555,174) | (4,091,319) |
Additions to patent rights | (39,019) | (960,260) |
Proceeds from maturities of investment securities | 6,000,000 | 6,000,000 |
Purchases of investment securities | (15,037,675) | |
Net cash provided by (used in) investing activities | 3,405,807 | (14,089,254) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock, net | 43,115,000 | |
Taxes paid related to net share settlement of equity awards | (64,096) | (67,924) |
Net cash provided by (used in) financing activities | (64,096) | 43,047,076 |
Effect of exchange rate changes on cash | 1,947 | 982 |
Net increase (decrease) in cash | (5,339,468) | 9,095,746 |
Cash: | ||
Beginning of period | 32,898,676 | 34,028,889 |
End of period | 27,559,208 | 43,124,635 |
Supplemental disclosure of non-cash investing activities: | ||
Purchases of equipment, molds, furniture and fixtures recorded in accounts payable and accrued expenses | 1,293,346 | 423,360 |
Additions to patent rights recorded in accounts payable and accrued expenses | $ 32,586 | 47,287 |
Supplemental disclosure of non-cash financing activities: | ||
Expenses incurred in connection with issuance of common stock recorded in accounts payable and accrued expenses | $ 323,087 |
Description of Business
Description of Business | 6 Months Ended |
Jun. 30, 2016 | |
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 strategic alliances with Teva Pharmaceutical Industries, Ltd. (“Teva”), Ferring Pharmaceuticals Inc. and Ferring B.V. (together “Ferring”), JCR Pharmaceuticals Co., Ltd. (“JCR”) and AMAG Pharmaceuticals, Inc. (“AMAG”). 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 ® 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, children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis. 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 Sumatriptan Injection USP in adults for the acute treatment of migraine and cluster headache. Sumatriptan Injection USP is the Company’s first ANDA approval of a complex generic and second product approved using the VIBEX ® ® Antares also has a pipeline of proprietary and partnered products at various stages of development. The Company is currently conducting clinical studies of VIBEX ® ® |
Basis of Presentation and Signi
Basis of Presentation and Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2016 | |
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, 2015. Operating results for the three and six months ended June 30, 2016 are not necessarily indicative of the results that may be expected for the year ending December 31, 2016. Investments All 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 June 30, 2016 and December 31, 2015, the Company’s investments had a carrying value of $9,004,427 and $15,012,225, respectively. The fair value of the Company’s investments approximated their carrying value as of June 30, 2016 and December 31, 2015. 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 a reserve for potentially excess, dated or obsolete inventories based on an analysis of inventory on hand compared to forecasts of future sales, which was $725,000 and $800,000 at June 30, 2016 and December 31, 2015, respectively. Inventories consist of the following: June 30, December 31, 2016 2015 Inventories: Raw material $ 144,123 $ 305,149 Work in process 3,606,070 1,539,319 Finished goods 3,708,740 3,879,929 $ 7,458,933 $ 5,724,397 OTREXUP TM 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. The Company uses this third party prescription data, among other information, as a basis for revenue recognition in each reporting period. If patient prescriptions dispensed for a given period are underestimated or overestimated, adjustments to revenue may be necessary in future periods. 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. The Company recognized $3,810,291 and $7,120,065 in OTREXUP™ product revenue for the three and six months ended June 30, 2016, respectively, as compared to $3,346,094 and $6,350,403 for the three and six months ended June 30, 2015, respectively, which is presented net of product sales allowances for estimated wholesaler discounts, prompt pay discounts, chargebacks, rebates and patient discount programs. The Company had deferred revenue balances of $982,017 and $1,064,874 at June 30, 2016 and December 31, 2015, respectively, for OTREXUP™ product shipments, which is net of product sales allowances, discussed below. 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. Revenue Recognition – Sumatriptan 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 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. Revenues from the profit sharing arrangement will be recognized in future periods when amounts are fixed and determinable and are payable to the Company within 45 days after the end of each fiscal quarter in which commercial sales are made. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2016 | |
Equity [Abstract] | |
Stockholders' Equity | 3 . Stockholders’ Equity The Company’s Board of Directors unanimously approved, and recommended to the stockholders to approve and adopt, an amendment to the Company’s Certificate of Incorporation to increase the number of authorized shares of capital stock of the Company from 203,000,000 to 303,000,000 in order 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 held on June 2, 2016. |
Share Based Compensation
Share Based Compensation | 6 Months Ended |
Jun. 30, 2016 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Share Based Compensation | 4 . Share-Based Compensation The Company’s 2008 Equity Compensation Plan (the “Plan”) was amended and restated pursuant to stockholder approval on June 2, 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 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. The maximum number of shares authorized for issuance under the amended and restated Plan is 32,200,000 and the maximum number of shares of stock that may be granted to any one employee for qualified performance-based compensation 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 ten years and the options typically vest in quarterly installments over a three-year period with a minimum vesting period of one year. As of June 30, 2016 the Plan had approximately 8,000,000 shares available for grant. Stock Options The following is a summary of stock option activity under the Plan as of and for the six months ended June 30, 2016: Weighted Weighted Average Average Remaining Aggregate Number of Exercise Contractual Intrinsic Shares Price ($) Term (Years) Value ($) Outstanding at December 31, 2015 9,480,497 2.19 Granted 3,767,500 1.10 Exercised — — Cancelled/Forfeited (922,124 ) 1.90 Outstanding at June 30, 2016 12,325,873 1.88 7.5 466,844 Exercisable at June 30, 2016 7,255,500 2.20 6.1 409,712 The per share weighted average fair values of all options granted during the six months ended June 30, 2016 and 2015 were estimated as $0.54 and $1.10, 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. June 30, 2016 2015 Risk-free interest rate 1.3 % 1.3 % Annualized volatility 51.6 % 53.8 % Weighted average expected life, in years 6.00 6.00 Expected dividend yield 0.0 % 0.0 % There were no stock option exercises during the six months ended June 30, 2016 and 2015, respectively. The Company recognized $1,067,047 and $1,411,005 in compensation expense related to stock options for the six months ended June 30, 2016 and 2015, respectively, and stock compensation expense of $504,814 and $770,214 for the three months ended June 30, 2016 and 2015, respectively. As of June 30, 2016, there was approximately $3,080,000 of total unrecognized compensation cost related to nonvested outstanding stock options that is expected to be recognized over a weighted average period of approximately 2.19 years. Long Term Incentive Program (LTIP) The Company’s Board of Directors has approved a long term incentive program (“LTIP”) for the benefit of the Company’s senior executives. Pursuant to the LTIP, the Company’s senior executives have been awarded stock options, restricted stock units (“RSU”) and performance stock units (“PSU”) with targeted values based on values granted to similarly situated senior executives in the Company’s peer group. The stock options have a ten-year term, have an exercise price equal to the closing price of the Company’s common stock on the date of grant, vest in quarterly installments over three years, were otherwise granted on the same standard terms and conditions as other stock options granted pursuant to the Plan and are included in the stock options table above. The RSUs vest in three equal annual installments. The PSU awards made to the senior executives vest and convert into shares of the Company’s common stock based on the Company’s attainment of certain performance goals as established by the Company’s Board of Directors over a performance period, which is typically three to five years. The performance stock unit awards and restricted stock unit awards granted under the long term incentive program are summarized in the following table: Performance Stock Units Restricted Stock Units Number of Shares Weighted Average Date Fair Value ($) Number of Shares Weighted Average Grant Date Fair Value ($) Outstanding at December 31, 2015 956,178 2.40 714,828 2.32 Granted 750,500 1.12 750,500 1.12 Vested/settled (11,223 ) 3.96 (264,001 ) 2.41 Forfeited/expired (11,224 ) 3.96 (194,142 ) 2.31 Outstanding at June 30, 2016 1,684,231 1.82 1,007,185 1.41 In 2016 and 2015, the LTIP awards include PSUs that may be earned based on the Company’s total shareholder return (“TSR”) relative to the Nasdaq Biotechnology Index (“NBI”) at the end of the performance period, which performance period is January 1, 2015 to December 31, 2017 for the 2015 award and January 1, 2016 to December 31, 2018 for the 2016 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 0 150 2016 Award 2015 Award Closing stock price on grant date $ 1.12 $ 2.18 Performance period starting price $ 1.29 $ 2.52 Term of award (in years) 2.58 2.59 Volatility 70.1 % 60.5 % Risk-free interest rate 0.97 % 0.83 % Expected dividend yield 0.00 % 0.00 % Fair value per TSR PSU $ 1.25 $ 1.71 The performance period starting price is measured as the average closing price over the last 20 trading days prior to the performance period start. The Monte Carlo simulation model also assumed correlations of returns of the prices of the Company’s common stock and the common stocks of the NBI companies and stock price volatilities of the NBI companies. The fair value of the target number of shares that can be earned under the TSR PSUs is being recognized as compensation expense over the performance period. Total compensation expense recognized in connection with PSU awards was $8,294 and $62,638 for the six months ended June 30, 2016 and 2015, respectively. Compensation expense recognized in connection with RSU awards was $201,936 and $177,275 for the six months ended June 30, 2016 and 2015, respectively. Some of the shares issued in connection with RSU awards that vested in the six months ended June 30, 2016 and 2015 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 65,575 and 29,914 in the six months ended June 30, 2016 and 2015, 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 $64,096 and $67,924 in the six months ended June 30, 2016 and 2015, 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. |
Significant Customers and Conce
Significant Customers and Concentrations of Risk | 6 Months Ended |
Jun. 30, 2016 | |
Risks And Uncertainties [Abstract] | |
Significant Customers and Concentrations of Risk | 5 . Significant Customers and Concentrations of Risk Revenues by customer location are summarized as follows: Three Months Ended Six Months Ended June 30, June 30, 2016 2015 2016 2015 United States of America $ 11,024,136 $ 13,552,664 $ 21,594,742 $ 20,315,440 Europe 1,047,250 828,651 2,614,591 2,300,067 Other 157,004 39,076 337,829 152,921 $ 12,228,390 $ 14,420,391 $ 24,547,162 $ 22,768,428 Significant customers comprising 10% or more of total revenue are as follows: Three Months Ended Six Months Ended June 30, June 30, 2016 2015 2016 2015 Teva $ 6,505,126 $ 4,796,402 $ 12,990,976 $ 7,129,217 McKesson (1) 1,846,255 1,435,196 3,555,549 3,334,901 Ferring 1,055,767 828,651 2,714,389 2,300,067 AmerisourceBergen (1) 1,354,801 1,393,527 2,501,887 2,268,672 LEO Pharma (2) — 5,142,857 — 6,000,000 (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. (2) The licensing agreement with LEO Pharma A/S was terminated effective June 23, 2015 and accordingly no revenue was recognized or received from this customer for the three and six months ended June 30, 2016. |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2016 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 6 . 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 12,325,873 and 9,876,241 at June 30, 2016 and 2015, respectively. |
Recent Accounting Pronouncement
Recent Accounting Pronouncements | 6 Months Ended |
Jun. 30, 2016 | |
New Accounting Pronouncements And Changes In Accounting Principles [Abstract] | |
Recent Accounting Pronouncements | 7 . Recent Accounting Pronouncements In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, “Leases”, which is intended to increase transparency and comparability among organizations by recognizing all lease transactions (with terms in excess of 12 months) on the balance sheet as a lease liability and a right-of-use asset (as defined). ASU No. 2016-02 is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years, with earlier application permitted. Upon adoption, the lessee will apply the new standard retrospectively to all periods presented or retrospectively using a cumulative effect adjustment in the year of adoption. The Company is currently assessing the effect that ASU No. 2016-02 will have on its results of operations, cash flows and financial position. In March 2016, FASB issued ASU No. 2016-09, “Improvements to Employee Share-Based Payment Accounting”, as part of its simplification initiative. The areas of simplification involve several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. ASU No. 2016-09 is effective for annual and interim periods beginning after December 31, 2016. The Company is currently assessing the impact that the standard will have on its results of operations, cash flows and financial position. In March 2016, the FASB issued ASU No. 2016-08 “Principal Agent Considerations (Reporting Revenue Gross versus Net)” and in April 2016, FASB issued ASU No. 2016-10 “Identifying Performance Obligations and Licensing.” These updates amend, clarify and provide implementation guidance on the new revenue recognition standard ASU No. 2014-09, Revenue from Contract with Customers, which is effective for annual and interim periods beginning after December 15, 2017. The Company is currently evaluating the impact the adoption of these standards will have on its results of operations, cash flows and financial position. |
Basis of Presentation and Sig14
Basis of Presentation and Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2016 | |
Accounting Policies [Abstract] | |
Investments | Investments All 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 June 30, 2016 and December 31, 2015, the Company’s investments had a carrying value of $9,004,427 and $15,012,225, respectively. The fair value of the Company’s investments approximated their carrying value as of June 30, 2016 and December 31, 2015. |
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 a reserve for potentially excess, dated or obsolete inventories based on an analysis of inventory on hand compared to forecasts of future sales, which was $725,000 and $800,000 at June 30, 2016 and December 31, 2015, respectively. Inventories consist of the following: June 30, December 31, 2016 2015 Inventories: Raw material $ 144,123 $ 305,149 Work in process 3,606,070 1,539,319 Finished goods 3,708,740 3,879,929 $ 7,458,933 $ 5,724,397 |
Revenue Recognition | OTREXUP TM 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. The Company uses this third party prescription data, among other information, as a basis for revenue recognition in each reporting period. If patient prescriptions dispensed for a given period are underestimated or overestimated, adjustments to revenue may be necessary in future periods. 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. The Company recognized $3,810,291 and $7,120,065 in OTREXUP™ product revenue for the three and six months ended June 30, 2016, respectively, as compared to $3,346,094 and $6,350,403 for the three and six months ended June 30, 2015, respectively, which is presented net of product sales allowances for estimated wholesaler discounts, prompt pay discounts, chargebacks, rebates and patient discount programs. The Company had deferred revenue balances of $982,017 and $1,064,874 at June 30, 2016 and December 31, 2015, respectively, for OTREXUP™ product shipments, which is net of product sales allowances, discussed below. 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. Revenue Recognition – Sumatriptan 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 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. Revenues from the profit sharing arrangement will be recognized in future periods when amounts are fixed and determinable and are payable to the Company within 45 days after the end of each fiscal quarter in which commercial sales are made. |
Recent Accounting Pronouncements | In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, “Leases”, which is intended to increase transparency and comparability among organizations by recognizing all lease transactions (with terms in excess of 12 months) on the balance sheet as a lease liability and a right-of-use asset (as defined). ASU No. 2016-02 is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years, with earlier application permitted. Upon adoption, the lessee will apply the new standard retrospectively to all periods presented or retrospectively using a cumulative effect adjustment in the year of adoption. The Company is currently assessing the effect that ASU No. 2016-02 will have on its results of operations, cash flows and financial position. In March 2016, FASB issued ASU No. 2016-09, “Improvements to Employee Share-Based Payment Accounting”, as part of its simplification initiative. The areas of simplification involve several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. ASU No. 2016-09 is effective for annual and interim periods beginning after December 31, 2016. The Company is currently assessing the impact that the standard will have on its results of operations, cash flows and financial position. In March 2016, the FASB issued ASU No. 2016-08 “Principal Agent Considerations (Reporting Revenue Gross versus Net)” and in April 2016, FASB issued ASU No. 2016-10 “Identifying Performance Obligations and Licensing.” These updates amend, clarify and provide implementation guidance on the new revenue recognition standard ASU No. 2014-09, Revenue from Contract with Customers, which is effective for annual and interim periods beginning after December 15, 2017. The Company is currently evaluating the impact the adoption of these standards will have on its results of operations, cash flows and financial position. |
Basis of Presentation and Sig15
Basis of Presentation and Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Accounting Policies [Abstract] | |
Inventories | Inventories consist of the following: June 30, December 31, 2016 2015 Inventories: Raw material $ 144,123 $ 305,149 Work in process 3,606,070 1,539,319 Finished goods 3,708,740 3,879,929 $ 7,458,933 $ 5,724,397 |
Share Based Compensation (Table
Share Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Summary of Stock Option Activity | The following is a summary of stock option activity under the Plan as of and for the six months ended June 30, 2016: Weighted Weighted Average Average Remaining Aggregate Number of Exercise Contractual Intrinsic Shares Price ($) Term (Years) Value ($) Outstanding at December 31, 2015 9,480,497 2.19 Granted 3,767,500 1.10 Exercised — — Cancelled/Forfeited (922,124 ) 1.90 Outstanding at June 30, 2016 12,325,873 1.88 7.5 466,844 Exercisable at June 30, 2016 7,255,500 2.20 6.1 409,712 |
Assumptions Used in Fair Value Measurement of Options Granted | June 30, 2016 2015 Risk-free interest rate 1.3 % 1.3 % Annualized volatility 51.6 % 53.8 % Weighted average expected life, in years 6.00 6.00 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, 2015 956,178 2.40 714,828 2.32 Granted 750,500 1.12 750,500 1.12 Vested/settled (11,223 ) 3.96 (264,001 ) 2.41 Forfeited/expired (11,224 ) 3.96 (194,142 ) 2.31 Outstanding at June 30, 2016 1,684,231 1.82 1,007,185 1.41 |
Performance Stock Units [Member] | |
Assumptions Used in Fair Value Measurement of Options Granted | The fair values of the TSR PSUs granted in June 2016 and May 2015 was determined using a Monte Carlo simulation and utilized the following inputs and assumptions: 2016 Award 2015 Award Closing stock price on grant date $ 1.12 $ 2.18 Performance period starting price $ 1.29 $ 2.52 Term of award (in years) 2.58 2.59 Volatility 70.1 % 60.5 % Risk-free interest rate 0.97 % 0.83 % Expected dividend yield 0.00 % 0.00 % Fair value per TSR PSU $ 1.25 $ 1.71 |
Significant Customers and Con17
Significant Customers and Concentrations of Risk (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Risks And Uncertainties [Abstract] | |
Summary of Revenues by Customer Location | Revenues by customer location are summarized as follows: Three Months Ended Six Months Ended June 30, June 30, 2016 2015 2016 2015 United States of America $ 11,024,136 $ 13,552,664 $ 21,594,742 $ 20,315,440 Europe 1,047,250 828,651 2,614,591 2,300,067 Other 157,004 39,076 337,829 152,921 $ 12,228,390 $ 14,420,391 $ 24,547,162 $ 22,768,428 |
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 Six Months Ended June 30, June 30, 2016 2015 2016 2015 Teva $ 6,505,126 $ 4,796,402 $ 12,990,976 $ 7,129,217 McKesson (1) 1,846,255 1,435,196 3,555,549 3,334,901 Ferring 1,055,767 828,651 2,714,389 2,300,067 AmerisourceBergen (1) 1,354,801 1,393,527 2,501,887 2,268,672 LEO Pharma (2) — 5,142,857 — 6,000,000 (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. (2) The licensing agreement with LEO Pharma A/S was terminated effective June 23, 2015 and accordingly no revenue was recognized or received from this customer for the three and six months ended June 30, 2016. |
Basis of Presentation and Sig18
Basis of Presentation and Significant Accounting Policies - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | |
Summary Of Significant Accounting Policies [Line Items] | |||||
Carrying value of investments | $ 9,004,427 | $ 9,004,427 | $ 15,012,225 | ||
Fair value of investments | 9,004,427 | 9,004,427 | 15,012,225 | ||
Inventory reserve | 725,000 | 725,000 | 800,000 | ||
Product revenue | $ 8,690,002 | $ 5,840,034 | $ 19,531,049 | $ 10,463,164 | |
Cash discount to incentive for prompt payment | 2.00% | 2.00% | |||
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 | $ 3,810,291 | $ 3,346,094 | $ 7,120,065 | $ 6,350,403 | |
Deferred revenue balance | $ 982,017 | $ 982,017 | $ 1,064,874 |
Basis of Presentation and Sig19
Basis of Presentation and Significant Accounting Policies - Inventories (Detail) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 |
Inventories: | ||
Raw material | $ 144,123 | $ 305,149 |
Work in process | 3,606,070 | 1,539,319 |
Finished goods | 3,708,740 | 3,879,929 |
Inventory, Total | $ 7,458,933 | $ 5,724,397 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - $ / shares | Jun. 30, 2016 | Jun. 01, 2016 | Dec. 31, 2015 |
Stockholders Equity Note [Abstract] | |||
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 | 300,000,000 | 200,000,000 |
Share Based Compensation - Addi
Share Based Compensation - Additional Information (Detail) - USD ($) | Jun. 02, 2016 | Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares withheld to meet employees' minimum statutory income tax obligation | 65,575 | 29,914 | |||
Payments for the employees' minimum statutory income tax obligation | $ 64,096 | $ 67,924 | |||
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 | 8,000,000 | 8,000,000 | |||
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] | |||||
Per share weighted average fair values of options granted | $ 0.54 | $ 1.10 | |||
Exercise of options, shares | 0 | 0 | |||
Recognized compensation cost related to shares of stock granted | $ 504,814 | $ 770,214 | $ 1,067,047 | $ 1,411,005 | |
Unrecognized compensation cost related to nonvested outstanding stock awards | $ 3,080,000 | $ 3,080,000 | |||
Weighted average period expected to be recognized | 2 years 2 months 9 days | ||||
Stock Options [Member] | Long Term Incentive Program [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period | 3 years | ||||
Contractual term of options granted | 10 years | ||||
Stock Options [Member] | Amended and Restated 2008 Equity Compensation Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period | 3 years | ||||
Contractual term of options granted | 10 years | ||||
Stock Options [Member] | Minimum [Member] | Amended and Restated 2008 Equity Compensation Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period | 1 year | ||||
Restricted Stock Units [Member] | 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 | $ 201,936 | 177,275 | |||
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 | $ 8,294 | $ 62,638 | |||
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 - Summ
Share Based Compensation - Summary of Stock Option Activity (Detail) | 6 Months Ended |
Jun. 30, 2016USD ($)$ / sharesshares | |
Stockholders Equity Note [Abstract] | |
Number of Shares Outstanding, Beginning Balance | shares | 9,480,497 |
Number of Shares Granted | shares | 3,767,500 |
Number of Shares Cancelled/Forfeited | shares | (922,124) |
Number of Shares Outstanding, Ending Balance | shares | 12,325,873 |
Number of Shares Exercisable, Ending Balance | shares | 7,255,500 |
Weighted Average Exercise Price Outstanding, Beginning Balance | $ / shares | $ 2.19 |
Weighted Average Exercise Price Granted | $ / shares | 1.10 |
Weighted Average Exercise Price Cancelled/Forfeited | $ / shares | 1.90 |
Weighted Average Exercise Price Outstanding, Ending Balance | $ / shares | 1.88 |
Weighted Average Exercise Price Exercisable, Ending Balance | $ / shares | $ 2.20 |
Weighted Average Remaining Contractual Term (Years) Outstanding, Ending Balance | 7 years 6 months |
Weighted Average Remaining Contractual Term (Years) Exercisable, Ending Balance | 6 years 1 month 6 days |
Aggregate Intrinsic Value Outstanding, Ending Balance | $ | $ 466,844 |
Aggregate Intrinsic Value Exercisable, Ending Balance | $ | $ 409,712 |
Share Based Compensation - Assu
Share Based Compensation - Assumptions Used in Fair Value Measurement of Options Granted (Detail) | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Stockholders Equity Note [Abstract] | ||
Risk-free interest rate | 1.30% | 1.30% |
Annualized volatility | 51.60% | 53.80% |
Weighted average expected life, in years | 6 years | 6 years |
Expected dividend yield | 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) | 6 Months Ended |
Jun. 30, 2016$ / sharesshares | |
Performance Stock Units [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares, Beginning Balance | shares | 956,178 |
Number of Shares, Granted | shares | 750,500 |
Number of Shares, Vested/settled | shares | (11,223) |
Number of Shares, Forfeited/expired | shares | (11,224) |
Number of Shares, Ending Balance | shares | 1,684,231 |
Weighted Average Grant Date Fair Value, Beginning Balance | $ / shares | $ 2.40 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | 1.12 |
Weighted Average Grant Date Fair Value, Vested/settled | $ / shares | 3.96 |
Weighted Average Grant Date Fair Value, Forfeited/expired | $ / shares | 3.96 |
Weighted Average Grant Date Fair Value, Ending Balance | $ / shares | $ 1.82 |
Restricted Stock Units [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares, Beginning Balance | shares | 714,828 |
Number of Shares, Granted | shares | 750,500 |
Number of Shares, Vested/settled | shares | (264,001) |
Number of Shares, Forfeited/expired | shares | (194,142) |
Number of Shares, Ending Balance | shares | 1,007,185 |
Weighted Average Grant Date Fair Value, Beginning Balance | $ / shares | $ 2.32 |
Weighted Average Grant Date Fair Value, Granted | $ / shares | 1.12 |
Weighted Average Grant Date Fair Value, Vested/settled | $ / shares | 2.41 |
Weighted Average Grant Date Fair Value, Forfeited/expired | $ / shares | 2.31 |
Weighted Average Grant Date Fair Value, Ending Balance | $ / shares | $ 1.41 |
Share Based Compensation - Fair
Share Based Compensation - Fair Value of PSUs Granted Determined Using Monte Carlo Simulation (Detail) - $ / shares | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Term of award (in years) | 6 years | 6 years |
Volatility | 51.60% | 53.80% |
Risk-free interest rate | 1.30% | 1.30% |
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 | $ 1.12 | $ 2.18 |
Performance period starting price | $ 1.29 | $ 2.52 |
Term of award (in years) | 2 years 6 months 29 days | 2 years 7 months 2 days |
Volatility | 70.10% | 60.50% |
Risk-free interest rate | 0.97% | 0.83% |
Expected dividend yield | 0.00% | 0.00% |
Fair value per TSR PSU | $ 1.25 | $ 1.71 |
Significant Customers and Con26
Significant Customers and Concentrations of Risk - Revenues By Customer Location (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Concentration Risk [Line Items] | ||||
Total revenues | $ 12,228,390 | $ 14,420,391 | $ 24,547,162 | $ 22,768,428 |
United States of America [Member] | ||||
Concentration Risk [Line Items] | ||||
Total revenues | 11,024,136 | 13,552,664 | 21,594,742 | 20,315,440 |
Europe [Member] | ||||
Concentration Risk [Line Items] | ||||
Total revenues | 1,047,250 | 828,651 | 2,614,591 | 2,300,067 |
Other [Member] | ||||
Concentration Risk [Line Items] | ||||
Total revenues | $ 157,004 | $ 39,076 | $ 337,829 | $ 152,921 |
Significant Customers and Con27
Significant Customers and Concentrations of Risk - Summary of Significant Customers Comprising 10% or More of Total Revenue (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | ||||
Concentration Risk [Line Items] | |||||||
Total revenues | $ 12,228,390 | $ 14,420,391 | $ 24,547,162 | $ 22,768,428 | |||
Teva [Member] | |||||||
Concentration Risk [Line Items] | |||||||
Total revenues | 6,505,126 | 4,796,402 | 12,990,976 | 7,129,217 | |||
McKesson [Member] | |||||||
Concentration Risk [Line Items] | |||||||
Total revenues | [1] | 1,846,255 | 1,435,196 | 3,555,549 | 3,334,901 | ||
Ferring [Member] | |||||||
Concentration Risk [Line Items] | |||||||
Total revenues | 1,055,767 | 828,651 | 2,714,389 | 2,300,067 | |||
AmerisourceBergen [Member] | |||||||
Concentration Risk [Line Items] | |||||||
Total revenues | [1] | 1,354,801 | 1,393,527 | 2,501,887 | 2,268,672 | ||
LEO Pharma [Member] | |||||||
Concentration Risk [Line Items] | |||||||
Total revenues | $ 0 | $ 5,142,857 | [2] | $ 0 | $ 6,000,000 | [2] | |
[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. | ||||||
[2] | The licensing agreement with LEO Pharma A/S was terminated effective June 23, 2015 and accordingly no revenue was recognized or received from this customer for the three and six months ended June 30, 2016. |
Significant Customers and Con28
Significant Customers and Concentrations of Risk - Summary of Significant Customers Comprising 10% or More of Total Revenue (Detail) (Parenthetical) - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |||
Concentration Risk [Line Items] | ||||||
Revenue recognized | $ 12,228,390 | $ 14,420,391 | $ 24,547,162 | $ 22,768,428 | ||
LEO Pharma [Member] | ||||||
Concentration Risk [Line Items] | ||||||
Revenue recognized | $ 0 | $ 5,142,857 | [1] | $ 0 | $ 6,000,000 | [1] |
[1] | The licensing agreement with LEO Pharma A/S was terminated effective June 23, 2015 and accordingly no revenue was recognized or received from this customer for the three and six months ended June 30, 2016. |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Detail) - shares | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Earnings Per Share [Abstract] | ||
Potentially dilutive stock options excluded from dilutive loss per share | 12,325,873 | 9,876,241 |