Document_and_Entity_Informatio
Document and Entity Information | 3 Months Ended | |
Mar. 31, 2015 | 1-May-15 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | FALSE | |
Document Period End Date | 31-Mar-15 | |
Document Fiscal Year Focus | 2015 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | ATRS | |
Entity Registrant Name | ANTARES PHARMA, INC. | |
Entity Central Index Key | 1016169 | |
Current Fiscal Year End Date | -19 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 131,751,104 |
Consolidated_Balance_Sheets
Consolidated Balance Sheets (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
Current Assets: | ||
Cash and cash equivalents | $23,543,024 | $34,028,889 |
Short-term investments | 3,001,024 | 6,002,438 |
Accounts receivable | 4,208,270 | 3,510,051 |
Inventories | 5,896,998 | 5,859,924 |
Deferred costs | 1,708,664 | 1,913,921 |
Prepaid expenses and other current assets | 3,006,784 | 2,322,464 |
Total current assets | 41,364,764 | 53,637,687 |
Equipment, molds, furniture and fixtures, net | 13,105,046 | 10,828,741 |
Patent rights, net | 2,778,522 | 2,885,024 |
Goodwill | 1,095,355 | 1,095,355 |
Other assets | 326,056 | 325,955 |
Total Assets | 58,669,743 | 68,772,762 |
Current Liabilities: | ||
Accounts payable | 8,852,636 | 10,071,504 |
Accrued expenses and other liabilities | 4,759,033 | 5,635,559 |
Deferred revenue | 7,435,518 | 8,520,517 |
Total current liabilities | 21,047,187 | 24,227,580 |
Deferred revenue - long term | 2,472,483 | 3,349,026 |
Total liabilities | 23,519,670 | 27,576,606 |
Stockholders' Equity: | ||
Preferred Stock: $0.01 par, authorized 3,000,000 shares, none outstanding | 0 | 0 |
Common Stock: $0.01 par; authorized 200,000,000 shares; 131,751,105 and 131,743,365 issued and outstanding at March 31, 2015 and December 31, 2014, respectively | 1,317,511 | 1,317,433 |
Additional paid-in capital | 249,761,515 | 249,032,066 |
Accumulated deficit | -215,235,330 | -208,447,656 |
Accumulated other comprehensive loss | -693,623 | -705,687 |
Total Stockholders' Equity | 35,150,073 | 41,196,156 |
Total Liabilities and Stockholders' Equity | $58,669,743 | $68,772,762 |
Consolidated_Balance_Sheets_Pa
Consolidated Balance Sheets (Parenthetical) (USD $) | Mar. 31, 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 | 131,751,105 | 131,743,365 |
Common Stock, shares outstanding | 131,751,105 | 131,743,365 |
Consolidated_Statements_of_Ope
Consolidated Statements of Operations (Unaudited) (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Revenue: | ||
Product sales | $4,623,130 | $1,805,302 |
Development revenue | 2,388,403 | 1,421,149 |
Licensing revenue | 883,009 | 928,129 |
Royalties | 453,495 | 1,047,615 |
Total revenue | 8,348,037 | 5,202,195 |
Cost of revenue: | ||
Cost of product sales | 1,957,573 | 1,017,437 |
Cost of development revenue | 1,717,156 | 159,308 |
Total cost of revenue | 3,674,729 | 1,176,745 |
Gross profit | 4,673,308 | 4,025,450 |
Operating expenses: | ||
Research and development | 4,377,981 | 4,533,626 |
Selling, general and administrative | 7,037,290 | 8,300,168 |
Total operating expenses | 11,415,271 | 12,833,794 |
Operating loss | -6,741,963 | -8,808,344 |
Other income (expense) | -45,711 | 13,739 |
Net loss | ($6,787,674) | ($8,794,605) |
Basic and diluted net loss per common share | ($0.05) | ($0.07) |
Basic and diluted weighted average common shares outstanding | 131,744,741 | 129,656,257 |
Consolidated_Statements_of_Com
Consolidated Statements of Comprehensive Loss (Unaudited) (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | ($6,787,674) | ($8,794,605) |
Foreign currency translation adjustment | 12,064 | 2,191 |
Comprehensive loss | ($6,775,610) | ($8,792,414) |
Consolidated_Statements_of_Cas
Consolidated Statements of Cash Flows (Unaudited) (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Cash flows from operating activities: | ||
Net loss | ($6,787,674) | ($8,794,605) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 378,555 | 224,753 |
Stock-based compensation expense | 733,695 | 621,427 |
Amortization of premiums and discounts | 1,414 | 15,111 |
Changes in operating assets and liabilities: | ||
Accounts receivable | -694,369 | -2,613,670 |
Inventories | -37,074 | -644,961 |
Prepaid expenses and other current assets | -684,112 | 710,189 |
Deferred costs | 205,257 | -169,259 |
Accounts payable | -392,895 | -1,144,516 |
Accrued expenses and other current liabilities | -1,415,479 | -939,596 |
Deferred revenue | -1,965,551 | 5,774,239 |
Net cash used in operating activities | -10,658,233 | -6,960,888 |
Cash flows from investing activities: | ||
Purchases of equipment, molds, furniture and fixtures | -1,889,615 | -128,701 |
Additions to patent rights | -927,631 | -42,259 |
Proceeds from maturities of investment securities | 3,000,000 | 6,000,000 |
Net cash provided by investing activities | 182,754 | 5,829,040 |
Cash flows from financing activities: | ||
Proceeds from exercise of stock options and warrants | 1,236,935 | |
Taxes paid related to net share settlement of equity awards | -11,277 | -115,123 |
Net cash provided by (used in) financing activities | -11,277 | 1,121,812 |
Effect of exchange rate changes on cash and cash equivalents | 891 | 250 |
Net decrease in cash and cash equivalents | -10,485,865 | -9,786 |
Cash and cash equivalents: | ||
Beginning of period | 34,028,889 | 39,067,236 |
End of period | 23,543,024 | 39,057,450 |
Noncash investing activities: | ||
Purchases of equipment, molds, furniture and fixtures recorded in accounts payable and accrued expenses | 1,754,053 | 739,713 |
Additions to patent rights recorded in accounts payable and accrued expenses | $32,629 | $771,100 |
Description_of_Business
Description of Business | 3 Months Ended | ||
Mar. 31, 2015 | |||
Accounting Policies [Abstract] | |||
Description of Business | 1 | Description of Business | |
Antares Pharma, Inc. (“Antares” or the “Company”) is an emerging, specialty pharmaceutical company that focuses on developing and commercializing self-administered parenteral pharmaceutical products and technologies. Antares has numerous partnerships with pharmaceutical companies as well as multiple internal product development programs. | |||
The Company develops and manufactures for itself and with partners, novel, pressure-assisted injectors, with and without needles, which allow patients to self-inject drugs. Antares has 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. Antares also developed a disposable multi-dose pen injector for use with standard cartridges. The Company has entered into multiple licenses for these devices mainly in the United States (“U.S.”), Europe and Canada with Teva Pharmaceutical Industries, Ltd. (“Teva”). | |||
The Company has developed the Vibex® auto injector for its product OTREXUP™ (methotrexate) injection. In February 2014, Antares launched 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 (“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 worldwide marketing rights for OTREXUP™ and commercializes OTREXUP™ on its own in the U.S. for the treatment of RA. The Company provided LEO Pharma A/S (“LEO Pharma”) an exclusive license to commercialize OTREXUP™ in the U.S. for the treatment of psoriasis. As discussed in Note 8 to the Condensed Consolidated Financial Statements, the agreement with LEO Pharma was terminated in April 2015 and will end on June 23, 2015, at which time the Company will regain the marketing rights in the U.S. for OTREXUP™ the treatment of psoriasis. | |||
The Company is currently conducting clinical studies of Vibex® QuickShot® Testosterone (“QS T”), for testosterone replacement therapy. On February 25, 2015, Antares announced positive top-line pharmacokinetic results that showed that the primary endpoint was achieved in the Company’s ongoing, multi-center, phase 3 clinical study (QST-13-003) evaluating the efficacy and safety of testosterone enanthate administered once-weekly by subcutaneous injection using the QuickShot® auto injector in testosterone deficient adult males. The Company also has initiated manufacturing development work for QS M, a combination product for an undisclosed central nervous system (“CNS”) indication. | |||
Antares also is developing VIBEX® Sumatriptan for the acute treatment of migraines which if approved will be distributed by Teva. In January 2015, the Company received a complete response letter from FDA regarding its Abbreviated New Drug Application (“ANDA”) for VIBEX® Sumatriptan, providing revisions to labelling and citing minor deficiencies, and the Company submitted its response in March 2015. We have begun commercial scale tooling and mold fabrication in anticipation of potential approval and launch. | |||
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”. | |||
The Company also makes a reusable, needle-free, spring-action injector device known as the Tjet® and Zomajet®, which is marketed for use with human growth hormone (“hGH”). Antares has had success in achieving distribution of this device for use with hGH through licenses to pharmaceutical partners, Ferring Pharmaceuticals Inc. and Ferring B.V. (together “Ferring”) and JCR Pharmaceuticals Co., Ltd. (“JCR”), and it has resulted in 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® 2 Vision and Zomajet® Vision X worldwide. Ferring purchased the U.S. rights to TEV-TROPIN® (Teva’s hGH), and Tjet® in December 2014 from Teva. In March 2015, Ferring received FDA approval of a name change enabling TEV-TROPIN® to be marketed in the U.S. as ZOMACTON™ (somatropin [rDNA origin]) for injection and the Tjet® needle-free delivery system to be marketed in the U.S. as ZOMA-Jet™. Also in March 2015, Ferring received approval from the FDA to market the 10 mg needle free injector device which, along with certain consumables, is supplied by Antares to Ferring. Distribution of growth hormone injectors occurs in the U.S., Europe, Japan and other Asian countries through our pharmaceutical company relationships. | |||
The Company also has a portfolio of gel-based products which are commercialized through various partners. Antares received FDA approval in December 2011 for an oxybutynin gel product, Gelnique 3%™, for the treatment of overactive bladder (“OAB”). The Company has a licensing agreement with Actavis plc (“Actavis”) under which Actavis is currently marketing Gelnique 3%™ in the U.S. Elestrin® (estradiol gel) is currently marketed by Meda Pharmaceuticals, Inc. (“Meda”) in the U.S. for the treatment of moderate-to-severe vasomotor symptoms associated with menopause. |
Basis_of_Presentation_and_Sign
Basis of Presentation and Significant Accounting Policies | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Accounting Policies [Abstract] | |||||||||
Basis of Presentation and Significant Accounting Policies | 2 | Basis of Presentation and Significant Accounting Policies | |||||||
The accompanying unaudited condensed 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 condensed consolidated financial statements and notes 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 months ended March 31, 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 condensed 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 had 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 the Company has the positive intent and ability to hold the securities to maturity. The securities are carried at their amortized cost. The fair value of all securities is determined by quoted market prices. At March 31, 2015, the short-term investments had a fair value of $3,001,875 and a carrying value of $3,001,024. At December 31, 2014, the short-term investments had a fair value of $6,005,040 and a carrying value of $6,002,438. | |||||||||
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: | |||||||||
March 31, | December 31, | ||||||||
2015 | 2014 | ||||||||
Inventories: | |||||||||
Raw material | $ | 489,297 | $ | 461,396 | |||||
Work in process | 2,216,966 | 3,896,837 | |||||||
Finished goods | 3,190,735 | 1,501,691 | |||||||
$ | 5,896,998 | $ | 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 March 31, 2015 and December 31, 2014, approximately $1,800,000 of 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 $3,004,309 and $212,845 in OTREXUP™ product revenue from U.S. customers for the three months ended March 31, 2015 and 2014, respectively, which is net of estimated wholesaler discounts, prompt pay discounts, chargebacks, rebates and patient discount programs. The Company had a deferred revenue balance of $1,067,165 and $1,061,947 at March 31, 2015 and December 31, 2014, respectively, for OTREXUP™ product shipments, which is net of estimated wholesaler discounts, prompt pay discounts, chargebacks, rebates and patient discount programs. | |||||||||
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. Through March 31, 2015, the Company has been subject to a minimal amount of chargebacks. The Company expects to provide discounts primarily to authorized users of the Federal Supply Schedule (“FSS”) of the General Services Administration under an FSS contract negotiated by the Department of Veterans Affairs and various organizations under Medicaid contracts and regulations. These entities purchase products from the wholesale distributors at a discounted price, and the wholesale distributors then charge back to the Company the difference between the current wholesale acquisition cost and the price the entity paid for the product. The Company will estimate and accrue chargebacks based on estimated wholesaler inventory levels, current contract prices and historical chargeback activity. Chargebacks are recognized as a reduction of revenue in the same period the related revenue is recognized. | |||||||||
Rebates. The Company participates in certain rebate programs, which provide discounted prescriptions to qualified insured patients. Under these rebate programs, the Company will pay a rebate to the third-party administrator of the program, generally two to three months after the quarter in which prescriptions subject to the rebate are filled. The Company estimates and accrues for these rebates based on current contract prices, historical and estimated 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. |
Stockholders_Equity
Stockholders' Equity | 3 Months Ended | ||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||
Equity [Abstract] | |||||||||||||||||
Stockholders' Equity | 3 | Stockholders’ Equity | |||||||||||||||
The Company records compensation expense associated with share based awards granted to employees at the fair value of the award on the date of grant. The expense is recognized over the period during which an employee is required to provide services in exchange for the award. | |||||||||||||||||
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. Under the Plan, the maximum number of shares authorized for issuance 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 10 years and the options typically vest in quarterly installments over a three-year period. As of March 31, 2015, the Plan had 4,016,156 shares available for grant. Stock option exercises are satisfied through the issuance of new shares. | |||||||||||||||||
Stock Options | |||||||||||||||||
A summary of stock option activity under the Plan as of March 31, 2015, and the changes during the three months then ended is as follows: | |||||||||||||||||
Number of | Weighted | Weighted | Aggregate | ||||||||||||||
Shares | Average | Average | Intrinsic | ||||||||||||||
Exercise | Remaining | Value ($) | |||||||||||||||
Price ($) | Contractual | ||||||||||||||||
Term (Years) | |||||||||||||||||
Outstanding at December 31, 2014 | 7,245,485 | 2.25 | |||||||||||||||
Granted | 275,000 | 2.59 | |||||||||||||||
Exercised | — | — | — | ||||||||||||||
Cancelled/Forfeited | (19,959 | ) | 3.16 | ||||||||||||||
Outstanding at March 31, 2015 | 7,500,526 | 2.26 | 6.6 | 5,249,105 | |||||||||||||
Exercisable at March 31, 2015 | 5,230,969 | 1.96 | 5.4 | 4,970,719 | |||||||||||||
In March 2015, the Company granted to its executive officers, as consideration for 2014 performance, a total of 245,000 stock options, which vest quarterly over a one-year period. The per share weighted average fair values of all options granted during the first three months of 2015 and 2014 were estimated as $1.35 and $2.55, 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. | |||||||||||||||||
March 31, | |||||||||||||||||
2015 | 2014 | ||||||||||||||||
Risk-free interest rate | 1.5 | % | 1.7 | % | |||||||||||||
Annualized volatility | 54.8 | % | 61.7 | % | |||||||||||||
Weighted average expected life, in years | 6 | 6 | |||||||||||||||
Expected dividend yield | 0 | % | 0 | % | |||||||||||||
There were no stock option exercises in the first three months of 2015. In the first three months of 2014, 570,178 stock options with a weighted average exercise price of $1.21 were exercised which generated proceeds of $691,935 to the Company. | |||||||||||||||||
Total recognized compensation expense for stock options was approximately $641,000 and $360,000 for the first three months of 2015 and 2014, respectively. As of March 31, 2015, there was approximately $3,133,000 of total unrecognized compensation cost related to nonvested outstanding stock options that is expected to be recognized over a weighted average period of approximately 2.0 years. | |||||||||||||||||
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 three months of 2015. In the first three months of 2014, there were 150,000 shares of common stock granted to members of executive management as bonus compensation for achievements in 2013. | |||||||||||||||||
Expense is recognized on a straight line basis over the vesting period and is based on the fair value of the stock on the grant date. The fair value of each stock award is determined based on the number of shares granted and the market price of the Company’s common stock on the date of grant. | |||||||||||||||||
In addition to the shares granted to members of management and employees, at times directors receive a portion of their annual compensation in shares of Company common stock. In 2015 and 2014, no shares were granted to the directors, as all directors’ compensation was paid in cash and stock options. Expense is recognized on a straight line basis over the one-year period in which the compensation is earned. Expense recognized in connection with shares granted to directors was $179,600 in the three-month period ended March 31, 2014. | |||||||||||||||||
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. Expense recognized in the first three months of 2015 and 2014 in connection with the RSUs was approximately $57,800 and $51,000, respectively. | |||||||||||||||||
The PSU awards made to the senior executives will be vested and convert into actual 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 2014 awards included 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. These PSUs were granted with a grant date fair value of $2.64. 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 value of the TSR PSUs granted in May 2014 was determined using a Monte Carlo simulation and utilized the following inputs and assumptions: | |||||||||||||||||
Closing stock price on grant date | $ | 3.09 | |||||||||||||||
Performance period starting price | $ | 4.08 | |||||||||||||||
Term of award (in years) | 2.59 | ||||||||||||||||
Volatility | 50.87 | % | |||||||||||||||
Risk-free interest rate | 0.61 | % | |||||||||||||||
Expected dividend yield | 0 | % | |||||||||||||||
Fair value per TSR PSU | $ | 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, and expense of $31,500 was recognized in connection with this award in the first three months of 2015. Expense recognized in the first three months of 2015 and 2014 in connection with other PSU awards for defined performance goals considered probable of achievement was $3,600 and $31,000, respectively. | |||||||||||||||||
At March 31, 2015 and December 31, 2014, there were 463,542 PSUs outstanding with a weighted average fair value of $3.08. At March 31, 2015 and December 31, 2014, there were 231,124 restricted shares or RSUs outstanding, with a weighted average fair value of $3.07. There were no PSUs or RSUs granted, vested, forfeited or expired in the first quarter of 2015. | |||||||||||||||||
Shares issued in the first three months of 2015 were net-share settled such that the Company withheld shares with value equivalent to the employees’ minimum statutory obligation for the applicable income and other employment taxes, and remitted the cash to the appropriate taxing authorities. The total shares withheld were 4,779 and 25,545 in the three-month periods ended March 31, 2015 and 2014, respectively, and were based on the value of the shares on their vesting date as determined by the Company’s closing stock price. Total payments for the employees’ tax obligations to the taxing authorities were $11,277 and $115,123 in the three-month periods ended March 31, 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 three months of 2014, the Company received proceeds of $545,000 from the exercise of 545,000 warrants. There were no warrants outstanding at March 31, 2015 or December 31, 2014. |
Net_Loss_Per_Share
Net Loss Per Share | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Earnings Per Share [Abstract] | |||||||||
Net Loss Per Share | 4 | 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 and warrants excluded from dilutive loss per share because their effect was anti-dilutive totaled 7,500,526 and 7,137,814 at March 31, 2015 and 2014, respectively. The table below discloses the basic and diluted loss per common share. | |||||||||
Three Months Ended | |||||||||
March 31, | |||||||||
2015 | 2014 | ||||||||
Net loss | $ | (6,787,674 | ) | $ | (8,794,605 | ) | |||
Basic and diluted weighted average common shares outstanding | 131,744,741 | 129,656,257 | |||||||
Basic and diluted net loss per common share | $ | (0.05 | ) | $ | (0.07 | ) | |||
Industry_Segment_and_Operation
Industry Segment and Operations by Geographic Areas | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Segment Reporting [Abstract] | |||||||||
Industry Segment and Operations by Geographic Areas | 5 | 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 | |||||||||
March 31, | |||||||||
2015 | 2014 | ||||||||
U.S. | $ | 6,762,776 | $ | 3,914,659 | |||||
Europe | 1,471,416 | 1,085,096 | |||||||
Other | 113,845 | 202,440 | |||||||
$ | 8,348,037 | $ | 5,202,195 | ||||||
Revenues by product type: | |||||||||
Three Months Ended | |||||||||
March 31, | |||||||||
2015 | 2014 | ||||||||
Injection devices and supplies | $ | 8,000,722 | $ | 4,806,782 | |||||
Transdermal products | 347,315 | 395,413 | |||||||
$ | 8,348,037 | $ | 5,202,195 | ||||||
Significant customers comprising 10% or more of total revenue are as follows: | |||||||||
Three Months Ended | |||||||||
March 31, | |||||||||
2015 | 2014 | ||||||||
Teva | $ | 2,332,815 | $ | 2,448,287 | |||||
McKesson (1) | 1,899,705 | 53,404 | |||||||
Ferring | 1,471,416 | 1,085,096 | |||||||
AmerisourceBergen (1) | 875,145 | 72,287 | |||||||
LEO Pharma | 857,143 | 857,143 | |||||||
-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 Condensed Consolidated Financial Statements. |
License_Agreements
License Agreements | 3 Months Ended | ||
Mar. 31, 2015 | |||
Deferred Revenue Disclosure [Abstract] | |||
License Agreements | 6 | License Agreements | |
LEO Pharma Promotion and License Agreement | |||
In November 2013, the Company entered into a promotion and license agreement with LEO Pharma. Under this agreement, the Company granted LEO Pharma the exclusive right to promote OTREXUP™ to dermatologists for symptomatic control of psoriasis in adults in the U.S. LEO Pharma is responsible for promotion and marketing activities in dermatology, and the Company is responsible for the supply of OTREXUP™ product and samples. The Company received from LEO Pharma a non-refundable upfront payment of $5.0 million and a milestone payment of $5.0 million. The Company pays LEO Pharma a percentage of net sales generated in dermatology and records the payments to LEO Pharma as sales and marketing expense. The deliverables in the agreement have been accounted for as a single unit of accounting and each of the payments has been allocated to these deliverables and are being recognized as revenue over the 35 month estimated life of the agreement. The Company recognized $857,000 of revenue in each of the three month periods ended March 31, 2015 and 2014, and recorded deferred revenue in connection with this agreement of $5,143,000 and $6,000,000 at March 31, 2015 and December 31, 2014, respectively. As discussed in Note 8, in April 2015, the agreement was terminated, and the Company regained U.S. marketing rights to OTREXUP™ for the psoriasis indication. |
Legal_Proceedings
Legal Proceedings | 3 Months Ended | ||
Mar. 31, 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, 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 and through the three months ended March 31, 2015, a total of approximately $1,800,000 in legal costs in connection with this suit has been 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 will be 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 of capitalized legal costs will continue to be amortized over the estimated useful life of the patents. |
Subsequent_Events
Subsequent Events | 3 Months Ended | ||
Mar. 31, 2015 | |||
Subsequent Events [Abstract] | |||
Subsequent Events | 8 | Subsequent Events | |
As discussed in Note 7 above, 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 discussed in Note 7 above and the proceeding pending before the Technical Board of Appeal of the European Patent Office will be dismissed. | |||
On April 27, 2015, the Company announced that it regained U.S. marketing rights to OTREXUPTM for the psoriasis indication through the termination of its exclusive promotion and marketing agreement with LEO Pharma for detailing OTREXUPTM to dermatologists for psoriasis. The collaboration will end on June 23, 2015. The Company previously received a total of $10 million in cash from LEO Pharma for the right to commercialize OTREXUPTM to dermatologists, which was recorded as deferred revenue and was being amortized to licensing revenue over a three-year period. As a result of the termination of the agreement with LEO Pharma, the Company expects to recognize the remaining unamortized balance of the deferred revenues of $5,142,857 as licensing revenue in the second quarter of 2015. | |||
On May 11, 2015, the Company completed an underwritten offering of 23,000,000 shares of its common stock, which includes 3,000,000 shares pursuant to the underwriters’ exercise of their option in full, at a price to the public of $2.00 per share. The Company received net proceeds of approximately $42.8 million, after deducting underwriting discounts and commissions and estimated offering expenses payable 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. |
Basis_of_Presentation_and_Sign1
Basis of Presentation and Significant Accounting Policies (Policies) | 3 Months Ended | ||||||||
Mar. 31, 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 the Company has the positive intent and ability to hold the securities to maturity. The securities are carried at their amortized cost. The fair value of all securities is determined by quoted market prices. At March 31, 2015, the short-term investments had a fair value of $3,001,875 and a carrying value of $3,001,024. At December 31, 2014, the short-term investments had a fair value of $6,005,040 and a carrying value of $6,002,438. | |||||||||
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: | |||||||||
March 31, | December 31, | ||||||||
2015 | 2014 | ||||||||
Inventories: | |||||||||
Raw material | $ | 489,297 | $ | 461,396 | |||||
Work in process | 2,216,966 | 3,896,837 | |||||||
Finished goods | 3,190,735 | 1,501,691 | |||||||
$ | 5,896,998 | $ | 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 March 31, 2015 and December 31, 2014, approximately $1,800,000 of 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 $3,004,309 and $212,845 in OTREXUP™ product revenue from U.S. customers for the three months ended March 31, 2015 and 2014, respectively, which is net of estimated wholesaler discounts, prompt pay discounts, chargebacks, rebates and patient discount programs. The Company had a deferred revenue balance of $1,067,165 and $1,061,947 at March 31, 2015 and December 31, 2014, respectively, for OTREXUP™ product shipments, which is net of estimated wholesaler discounts, prompt pay discounts, chargebacks, rebates and patient discount programs. | |||||||||
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. Through March 31, 2015, the Company has been subject to a minimal amount of chargebacks. The Company expects to provide discounts primarily to authorized users of the Federal Supply Schedule (“FSS”) of the General Services Administration under an FSS contract negotiated by the Department of Veterans Affairs and various organizations under Medicaid contracts and regulations. These entities purchase products from the wholesale distributors at a discounted price, and the wholesale distributors then charge back to the Company the difference between the current wholesale acquisition cost and the price the entity paid for the product. The Company will estimate and accrue chargebacks based on estimated wholesaler inventory levels, current contract prices and historical chargeback activity. Chargebacks are recognized as a reduction of revenue in the same period the related revenue is recognized. | |||||||||
Rebates. The Company participates in certain rebate programs, which provide discounted prescriptions to qualified insured patients. Under these rebate programs, the Company will pay a rebate to the third-party administrator of the program, generally two to three months after the quarter in which prescriptions subject to the rebate are filled. The Company estimates and accrues for these rebates based on current contract prices, historical and estimated 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. |
Basis_of_Presentation_and_Sign2
Basis of Presentation and Significant Accounting Policies (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Accounting Policies [Abstract] | |||||||||
Inventories | Inventories consist of the following: | ||||||||
March 31, | December 31, | ||||||||
2015 | 2014 | ||||||||
Inventories: | |||||||||
Raw material | $ | 489,297 | $ | 461,396 | |||||
Work in process | 2,216,966 | 3,896,837 | |||||||
Finished goods | 3,190,735 | 1,501,691 | |||||||
$ | 5,896,998 | $ | 5,859,924 | ||||||
Stockholders_Equity_Tables
Stockholders' Equity (Tables) | 3 Months Ended | ||||||||||||||||
Mar. 31, 2015 | |||||||||||||||||
Summary of Stock Option Activity | A summary of stock option activity under the Plan as of March 31, 2015, and the changes during the three months then ended is as follows: | ||||||||||||||||
Number of | Weighted | Weighted | Aggregate | ||||||||||||||
Shares | Average | Average | Intrinsic | ||||||||||||||
Exercise | Remaining | Value ($) | |||||||||||||||
Price ($) | Contractual | ||||||||||||||||
Term (Years) | |||||||||||||||||
Outstanding at December 31, 2014 | 7,245,485 | 2.25 | |||||||||||||||
Granted | 275,000 | 2.59 | |||||||||||||||
Exercised | — | — | — | ||||||||||||||
Cancelled/Forfeited | (19,959 | ) | 3.16 | ||||||||||||||
Outstanding at March 31, 2015 | 7,500,526 | 2.26 | 6.6 | 5,249,105 | |||||||||||||
Exercisable at March 31, 2015 | 5,230,969 | 1.96 | 5.4 | 4,970,719 | |||||||||||||
Assumptions Used in Fair Value Measurement of Options Granted | |||||||||||||||||
March 31, | |||||||||||||||||
2015 | 2014 | ||||||||||||||||
Risk-free interest rate | 1.5 | % | 1.7 | % | |||||||||||||
Annualized volatility | 54.8 | % | 61.7 | % | |||||||||||||
Weighted average expected life, in years | 6 | 6 | |||||||||||||||
Expected dividend yield | 0 | % | 0 | % | |||||||||||||
Performance Stock Units [Member] | |||||||||||||||||
Assumptions Used in Fair Value Measurement of Options Granted | The fair value of the TSR PSUs granted in May 2014 was determined using a Monte Carlo simulation and utilized the following inputs and assumptions: | ||||||||||||||||
Closing stock price on grant date | $ | 3.09 | |||||||||||||||
Performance period starting price | $ | 4.08 | |||||||||||||||
Term of award (in years) | 2.59 | ||||||||||||||||
Volatility | 50.87 | % | |||||||||||||||
Risk-free interest rate | 0.61 | % | |||||||||||||||
Expected dividend yield | 0 | % | |||||||||||||||
Fair value per TSR PSU | $ | 2.64 |
Net_Loss_Per_Share_Tables
Net Loss Per Share (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Earnings Per Share [Abstract] | |||||||||
Basic and Diluted Loss Per Common Share | The table below discloses the basic and diluted loss per common share. | ||||||||
Three Months Ended | |||||||||
March 31, | |||||||||
2015 | 2014 | ||||||||
Net loss | $ | (6,787,674 | ) | $ | (8,794,605 | ) | |||
Basic and diluted weighted average common shares outstanding | 131,744,741 | 129,656,257 | |||||||
Basic and diluted net loss per common share | $ | (0.05 | ) | $ | (0.07 | ) | |||
Industry_Segment_and_Operation1
Industry Segment and Operations by Geographic Areas (Tables) | 3 Months Ended | ||||||||
Mar. 31, 2015 | |||||||||
Segment Reporting [Abstract] | |||||||||
Summary of Revenues by Customer Location | Revenues by customer location are summarized as follows: | ||||||||
Three Months Ended | |||||||||
March 31, | |||||||||
2015 | 2014 | ||||||||
U.S. | $ | 6,762,776 | $ | 3,914,659 | |||||
Europe | 1,471,416 | 1,085,096 | |||||||
Other | 113,845 | 202,440 | |||||||
$ | 8,348,037 | $ | 5,202,195 | ||||||
Summary of Revenues by Product Type | Revenues by product type: | ||||||||
Three Months Ended | |||||||||
March 31, | |||||||||
2015 | 2014 | ||||||||
Injection devices and supplies | $ | 8,000,722 | $ | 4,806,782 | |||||
Transdermal products | 347,315 | 395,413 | |||||||
$ | 8,348,037 | $ | 5,202,195 | ||||||
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 | |||||||||
March 31, | |||||||||
2015 | 2014 | ||||||||
Teva | $ | 2,332,815 | $ | 2,448,287 | |||||
McKesson (1) | 1,899,705 | 53,404 | |||||||
Ferring | 1,471,416 | 1,085,096 | |||||||
AmerisourceBergen (1) | 875,145 | 72,287 | |||||||
LEO Pharma | 857,143 | 857,143 | |||||||
-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 Condensed Consolidated Financial Statements. |
Basis_of_Presentation_and_Sign3
Basis of Presentation and Significant Accounting Policies - Additional Information (Detail) (USD $) | 3 Months Ended | ||
Mar. 31, 2015 | Mar. 31, 2014 | Dec. 31, 2014 | |
Summary Of Significant Accounting Policies [Line Items] | |||
Short term investments, fair value | $3,001,875 | $6,005,040 | |
Short term investments, carrying value | 3,001,024 | 6,002,438 | |
Capitalized legal patent cost | 1,800,000 | 1,800,000 | |
U.S [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Product revenue | 3,004,309 | 212,845 | |
Deferred revenue balance | $1,067,165 | $1,061,947 | |
Cash discount to incentive for prompt payment | 2.00% |
Basis_of_Presentation_and_Sign4
Basis of Presentation and Significant Accounting Policies - Inventories (Detail) (USD $) | Mar. 31, 2015 | Dec. 31, 2014 |
Inventories | ||
Raw material | $489,297 | $461,396 |
Work in process | 2,216,966 | 3,896,837 |
Finished goods | 3,190,735 | 1,501,691 |
Inventory, Total | $5,896,998 | $5,859,924 |
Stockholders_Equity_Additional
Stockholders' Equity - Additional Information (Detail) (USD $) | 3 Months Ended | ||
Mar. 31, 2015 | Mar. 31, 2014 | Dec. 31, 2014 | |
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 | ||
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 | 4,016,156 | ||
Number of Shares Granted | 275,000 | ||
Number of stock options exercised | 0 | 570,178 | |
Weighted average exercise price of stock options | $0 | $1.21 | |
Shares withheld to meet employees' minimum statutory income tax obligation | 4,779 | 25,545 | |
Payments for the employees' minimum statutory income tax obligation | $11,277 | $115,123 | |
Long Term Incentive Program [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Contractual term of options granted | 10 years | ||
Employees [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Contractual term of options granted | 10 years | ||
Stock options granted vesting period | 3 years | ||
Warrant [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Proceeds from warrant exercised | 545,000 | ||
Warrants exercised | 545,000 | ||
Warrants outstanding | 0 | 0 | |
Directors [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Recognized compensation cost related to shares of stock granted | 0 | 179,600 | |
Performance Stock Units [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares per stock units outstanding | 463,542 | 463,542 | |
Weighted average fair value of shares per stock units | $3.08 | 3.08 | |
Number of shares per stock units granted | 0 | ||
Number of shares per stock units vested | 0 | ||
Number of shares per stock units forfeited or expired | 0 | ||
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 | 31,500 | ||
Per share weighted average grant date fair value of stock units | $2.64 | ||
Performance stock unit awards expenses and probable achievement | 3,600 | 31,000 | |
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% | ||
Performance Stock Units [Member] | Executive Officers [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock options granted vesting period | 1 year | ||
Number of Shares Granted | 245,000 | ||
Stock Options [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Per share weighted average fair value of options granted | $1.35 | $2.55 | |
Proceeds from the exercise of stock options | 691,935 | ||
Recognized compensation cost related to shares of stock granted | 641,000 | 360,000 | |
Unrecognized compensation cost related to nonvested outstanding stock awards | 3,133,000 | ||
Weighted average period expected to be recognized | 2 years | ||
Discretionary Shares [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based payment discretionary awards shares granted | 0 | 150,000 | |
Restricted Stock [Member] | Long Term Incentive Program [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock options granted vesting period | 3 years | ||
Recognized compensation cost related to shares of stock granted | $57,800 | $51,000 | |
Restricted Stock [Member] | Directors [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of Shares Granted | 0 | ||
Restricted Stock [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares per stock units outstanding | 231,124 | 231,124 | |
Weighted average fair value of shares per stock units | $3.07 | 3.07 | |
Number of shares per stock units granted | 0 | ||
Number of shares per stock units vested | 0 | ||
Number of shares per stock units forfeited or expired | 0 |
Stockholders_Equity_Summary_of
Stockholders' Equity - Summary of Stock Option Activity (Detail) (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Stockholders' Equity Note [Abstract] | ||
Number of Shares Outstanding, Beginning | 7,245,485 | |
Number of Shares Granted | 275,000 | |
Number of Shares Exercised | 0 | -570,178 |
Number of Shares Cancelled/Forfeited | -19,959 | |
Number of Shares Outstanding, Ending | 7,500,526 | |
Number of Shares Exercisable, Ending | 5,230,969 | |
Weighted Average Exercise Price Outstanding, Beginning Balance | $2.25 | |
Weighted Average Exercise Price Granted/Issued | $2.59 | |
Weighted Average Exercise Price Exercised | $0 | $1.21 |
Weighted Average Exercise Price Cancelled/Forfeited | $3.16 | |
Weighted Average Exercise Price Outstanding, Ending Balance | $2.26 | |
Weighted Average Exercise Price Exercisable, Ending Balance | $1.96 | |
Weighted Average Remaining Contractual Term Outstanding, Ending | 6 years 7 months 6 days | |
Weighted Average Remaining Contractual Term Exercisable, Ending | 5 years 4 months 24 days | |
Aggregate Intrinsic Value, Exercised | $0 | |
Aggregate Intrinsic Value Outstanding, Ending | 5,249,105 | |
Aggregate Intrinsic Value Exercisable, Ending | $4,970,719 |
Stockholders_Equity_Assumption
Stockholders' Equity - Assumptions Used in Fair Value Measurement of Options Granted (Detail) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Stockholders' Equity Note [Abstract] | ||
Risk-free interest rate | 1.50% | 1.70% |
Annualized volatility | 54.80% | 61.70% |
Weighted average expected life, in years | 6 years | 6 years |
Expected dividend yield | 0.00% | 0.00% |
Stockholders_Equity_Fair_Value
Stockholders' Equity - Fair Value of PSUs Granted Determined Using Monte Carlo Simulation (Detail) (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Term of award (in years) | 6 years | 6 years |
Volatility | 54.80% | 61.70% |
Risk-free interest rate | 1.50% | 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 | 3.09 | |
Performance period starting price | 4.08 | |
Term of award (in years) | 2 years 7 months 2 days | |
Volatility | 50.87% | |
Risk-free interest rate | 0.61% | |
Expected dividend yield | 0.00% | |
Fair value per TSR PSU | 2.64 |
Net_Loss_Per_Share_Additional_
Net Loss Per Share - Additional Information (Detail) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Earnings Per Share [Abstract] | ||
Dilutive stock options and warrants excluded from dilutive loss per share | 7,500,526 | 7,137,814 |
Net_Loss_Per_Share_Basic_and_D
Net Loss Per Share - Basic and Diluted Loss Per Common Share (Detail) (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Earnings Per Share [Abstract] | ||
Net loss | ($6,787,674) | ($8,794,605) |
Basic and diluted weighted average common shares outstanding | 131,744,741 | 129,656,257 |
Basic and diluted net loss per common share | ($0.05) | ($0.07) |
Industry_Segment_and_Operation2
Industry Segment and Operations by Geographic Areas - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2015 | |
Segment | |
Segment Reporting Information [Line Items] | |
Number of operating segment | 1 |
Sales Revenue, Net [Member] | |
Segment Reporting Information [Line Items] | |
Total revenue | 10.00% |
Industry_Segment_and_Operation3
Industry Segment and Operations by Geographic Areas - Revenues By Customer Location (Detail) (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Segment Reporting Information [Line Items] | ||
Total revenues | $8,348,037 | $5,202,195 |
U.S [Member] | ||
Segment Reporting Information [Line Items] | ||
Total revenues | 6,762,776 | 3,914,659 |
Europe [Member] | ||
Segment Reporting Information [Line Items] | ||
Total revenues | 1,471,416 | 1,085,096 |
Other [Member] | ||
Segment Reporting Information [Line Items] | ||
Total revenues | $113,845 | $202,440 |
Industry_Segment_and_Operation4
Industry Segment and Operations by Geographic Areas - Revenues By Product Type (Detail) (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Segment Reporting Information [Line Items] | ||
Total revenues | $8,348,037 | $5,202,195 |
Injection Devices and Supplies [Member] | ||
Segment Reporting Information [Line Items] | ||
Total revenues | 8,000,722 | 4,806,782 |
Transdermal Products [Member] | ||
Segment Reporting Information [Line Items] | ||
Total revenues | $347,315 | $395,413 |
Industry_Segment_and_Operation5
Industry Segment and Operations by Geographic Areas - Summary of Significant Customers Comprising 10% or More of Total Revenue (Detail) (USD $) | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | |
Segment Reporting Information [Line Items] | ||
Total revenues | $8,348,037 | $5,202,195 |
Teva [Member] | ||
Segment Reporting Information [Line Items] | ||
Total revenues | 2,332,815 | 2,448,287 |
McKesson [Member] | ||
Segment Reporting Information [Line Items] | ||
Total revenues | 1,899,705 | 53,404 |
Ferring [Member] | ||
Segment Reporting Information [Line Items] | ||
Total revenues | 1,471,416 | 1,085,096 |
AmerisourceBergen [Member] | ||
Segment Reporting Information [Line Items] | ||
Total revenues | 875,145 | 72,287 |
LEO Pharma [Member] | ||
Segment Reporting Information [Line Items] | ||
Total revenues | $857,143 | $857,143 |
License_Agreements_Additional_
License Agreements - Additional Information (Detail) (USD $) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |
Nov. 30, 2013 | Mar. 31, 2015 | Mar. 31, 2014 | Dec. 31, 2014 | |
Deferred Revenue Arrangement [Line Items] | ||||
Non refundable upfront payment | $5,000,000 | |||
Revenue recognized | 857,000 | 857,000 | ||
Deferred revenue recorded | 5,143,000 | 6,000,000 | ||
Revenue recognition period of deliverables | 35 months | |||
Performance Obligations [Member] | ||||
Deferred Revenue Arrangement [Line Items] | ||||
Milestone payment received | $5,000,000 |
Legal_Proceedings_Additional_I
Legal Proceedings - Additional Information (Detail) (USD $) | 3 Months Ended |
Mar. 31, 2015 | |
Patents | |
Commitments and Contingencies Disclosure [Abstract] | |
Legal costs capitalized as patent costs | $1,800,000 |
Number of patents | 2 |
Subsequent_Events_Additional_I
Subsequent Events - Additional Information (Detail) (USD $) | 3 Months Ended | 0 Months Ended | 3 Months Ended | |
Mar. 31, 2015 | Mar. 31, 2014 | 11-May-15 | Jun. 30, 2015 | |
Subsequent Event [Line Items] | ||||
Licensing revenue | $883,009 | $928,129 | ||
Subsequent Event [Member] | Underwritten Public Offering [Member] | ||||
Subsequent Event [Line Items] | ||||
Issuance of common stock, shares | 23,000,000 | |||
Common stock price per shares | $2 | |||
Proceeds from issuance of common stock, net | 42,800,000 | |||
Subsequent Event [Member] | Over-Allotment Option [Member] | ||||
Subsequent Event [Line Items] | ||||
Issuance of common stock, shares | 3,000,000 | |||
LEO Pharma [Member] | ||||
Subsequent Event [Line Items] | ||||
Deferred revenue | 10,000,000 | |||
Amortization of deferred revenue to licensing revenue period | 3 years | |||
LEO Pharma [Member] | Scenario, Forecast [Member] | ||||
Subsequent Event [Line Items] | ||||
Licensing revenue | $5,142,857 |