Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Sep. 30, 2014 | Nov. 03, 2014 | |
Document And Entity Information [Abstract] | ' | ' |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Period End Date | 30-Sep-14 | ' |
Document Fiscal Year Focus | '2014 | ' |
Document Fiscal Period Focus | 'Q3 | ' |
Trading Symbol | 'BDSI | ' |
Entity Registrant Name | 'BIODELIVERY SCIENCES INTERNATIONAL INC | ' |
Entity Central Index Key | '0001103021 | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Filer Category | 'Accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 51,285,938 |
Condensed_Consolidated_Balance
Condensed Consolidated Balance Sheets (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Current assets: | ' | ' |
Cash and cash equivalents | $85,793,950 | $23,175,809 |
Accounts receivable | 205,229 | 2,794,040 |
Inventory | 2,023,786 | ' |
Prepaid expenses and other current assets | 1,435,394 | 630,657 |
Total current assets | 89,458,359 | 26,600,506 |
Equipment, net | 1,464,484 | 178,168 |
Idle equipment, net | 2,738,898 | 2,844,718 |
Goodwill | 2,715,000 | 2,715,000 |
Other intangible assets: | ' | ' |
Licenses | 1,900,000 | 1,900,000 |
Acquired product rights | 9,050,000 | 9,050,000 |
Accumulated amortization | -6,481,269 | -5,753,502 |
Total other intangible assets | 4,468,731 | 5,196,498 |
Other assets | 235,268 | 470,535 |
Total assets | 101,080,740 | 38,005,425 |
Current liabilities: | ' | ' |
Accounts payable and accrued liabilities | 13,076,126 | 10,415,981 |
Notes payable, current maturities | 8,000,000 | 7,333,333 |
Deferred revenue, current | 842,792 | 2,927,088 |
Derivative liabilities | 12,579,418 | 4,315,183 |
Total current liabilities | 34,498,336 | 24,991,585 |
Notes payable, less current maturities | 6,091,296 | 11,844,706 |
Deferred revenue, long-term | 5,647,989 | 1,281,485 |
Other long-term liabilities | 700,000 | 700,000 |
Total liabilities | 46,937,621 | 38,817,776 |
Commitments and contingencies | ' | ' |
Stockholders' equity (deficit): | ' | ' |
Preferred Stock, $.001 par value; 5,000,000 shares authorized; 2,139,000 and 2,709,300 shares of Series A Non-Voting Convertible Preferred Stock outstanding at September 30, 2014 and December 31, 2013, respectively. | 2,139 | 2,709 |
Common Stock, $.001 par value; 75,000,000 shares authorized; 50,584,518 and 38,204,384 shares issued; 50,569,027 and 38,188,893 shares outstanding at September 30, 2014 and December 31, 2013, respectively | 50,585 | 38,204 |
Additional paid-in capital | 242,022,624 | 150,506,927 |
Treasury stock, at cost, 15,491 shares | -47,183 | -47,183 |
Accumulated deficit | -187,885,046 | -151,313,008 |
Total stockholders' equity (deficit) | 54,143,119 | -812,351 |
Total liabilities and stockholders' equity (deficit) | $101,080,740 | $38,005,425 |
Condensed_Consolidated_Balance1
Condensed Consolidated Balance Sheets (Parenthetical) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Preferred Stock, par value | $0.00 | $0.00 |
Preferred Stock, shares authorized | 5,000,000 | 5,000,000 |
Common Stock, par value | $0.00 | $0.00 |
Common Stock, shares authorized | 75,000,000 | 75,000,000 |
Common Stock, shares issued | 50,584,518 | 38,204,384 |
Common Stock, shares outstanding | 50,569,027 | 38,188,893 |
Treasury stock, shares | 15,491 | 15,491 |
Series A Non-Voting Convertible Preferred Stock [Member] | ' | ' |
Preferred Stock, shares outstanding | 2,139,000 | 2,709,300 |
Condensed_Consolidated_Stateme
Condensed Consolidated Statements of Operations (Unaudited) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Revenues: | ' | ' | ' | ' |
Product royalties | $11,832 | $924,272 | $1,857,920 | $1,779,373 |
Research and development reimbursements | 1,297,761 | ' | 12,067,324 | ' |
Contract revenues | 512,774 | 2,072,590 | 22,471,502 | 5,603,516 |
Total Revenues: | 1,822,367 | 2,996,862 | 36,396,746 | 7,382,889 |
Cost of sales | 462,802 | 643,486 | 1,875,365 | 1,708,693 |
Expenses: | ' | ' | ' | ' |
Research and development | 6,769,698 | 16,387,194 | 29,375,895 | 41,177,577 |
Selling, general and administrative | 13,648,648 | 3,049,005 | 25,532,632 | 9,099,515 |
Total Expenses: | 20,418,346 | 19,436,199 | 54,908,527 | 50,277,092 |
Loss from operations | -19,058,781 | -17,082,823 | -20,387,146 | -44,602,896 |
Interest expense, net | -514,718 | -450,328 | -1,588,736 | -281,812 |
Derivative (loss) gain | -5,684,893 | -917,863 | -14,630,675 | 499,671 |
Other income (expense), net | 2,134 | -35,433 | 34,519 | -154,061 |
Net loss before taxes | -25,256,258 | -18,486,447 | -36,572,038 | -44,539,098 |
Income tax expense | 0 | ' | 0 | -85,000 |
Net loss attributable to common stockholders | ($25,256,258) | ($18,486,447) | ($36,572,038) | ($44,624,098) |
Basic earnings per share: | ($0.51) | ($0.49) | ($0.77) | ($1.18) |
Diluted earnings per share: | ($0.51) | ($0.49) | ($0.77) | ($1.18) |
Weighted average common stock shares outstanding | 49,555,815 | 38,076,606 | 47,391,040 | 37,864,248 |
Condensed_Consolidated_Stateme1
Condensed Consolidated Statement of Stockholders' Equity (Deficit) (Unaudited) (USD $) | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Treasury Stock [Member] | Accumulated Deficit [Member] | Series A Preferred Stock [Member] |
Beginning Balance at Dec. 31, 2013 | ($812,351) | $38,204 | $150,506,927 | ($47,183) | ($151,313,008) | $2,709 |
Beginning Balance, shares at Dec. 31, 2013 | ' | 38,204,384 | ' | ' | ' | 2,709,300 |
Stock-based compensation | 4,857,230 | 0 | 4,857,230 | 0 | 0 | 0 |
Restricted stock awards | 0 | 474 | -474 | 0 | 0 | 0 |
Restricted stock awards, shares | ' | 473,893 | ' | ' | ' | 0 |
Exercise of stock options | 4,572,919 | 1,331 | 4,571,588 | 0 | 0 | 0 |
Exercise of stock options, shares | 1,337,878 | 1,331,063 | ' | ' | ' | 0 |
Exercise of warrants | 4,930,796 | 1,099 | 4,929,697 | 0 | 0 | 0 |
Exercise of warrants, shares | ' | 1,099,012 | ' | ' | ' | 0 |
Cashless exercise of warrants | 0 | 219 | -219 | 0 | 0 | 0 |
Cashless exercise of warrants, shares | ' | 218,367 | ' | ' | ' | 0 |
Shares issued pursuant to registered direct offering, net | 58,181,172 | 7,500 | 58,173,672 | 0 | 0 | 0 |
Shares issued pursuant to registered direct offering, shares | ' | 7,500,000 | ' | ' | ' | 0 |
Shares issued pursuant to an at the market offering, net | 12,536,614 | 1,188 | 12,535,426 | 0 | 0 | 0 |
Shares issued pursuant to an at the market offering, shares | ' | 1,187,499 | ' | ' | ' | 0 |
Warrant derivative liability reclassified to equity | 6,366,440 | 0 | 6,366,440 | 0 | 0 | 0 |
Short swing profit return | 82,337 | 0 | 82,337 | 0 | 0 | 0 |
Conversion of preferred shares to common shares | 0 | 570 | 0 | 0 | 0 | -570 |
Conversion of preferred shares to common shares, shares | ' | 570,300 | ' | ' | ' | -570,300 |
Net loss | -36,572,038 | 0 | 0 | 0 | -36,572,038 | 0 |
Ending Balance at Sep. 30, 2014 | $54,143,119 | $50,585 | $242,022,624 | ($47,183) | ($187,885,046) | $2,139 |
Ending Balance, shares at Sep. 30, 2014 | ' | 50,584,518 | ' | ' | ' | 2,139,000 |
Condensed_Consolidated_Stateme2
Condensed Consolidated Statements of Cash Flows (Unaudited) (USD $) | 9 Months Ended | |
Sep. 30, 2014 | Sep. 30, 2013 | |
Operating activities: | ' | ' |
Net loss | ($36,572,038) | ($44,624,098) |
Adjustments to reconcile net loss to net cash flows from operating activities: | ' | ' |
Depreciation and amortization | 783,127 | 936,231 |
Debt costs | 481,858 | 101,975 |
Derivative loss (gain) | 14,630,675 | -499,671 |
Purchase of Arcion license with common stock | ' | 2,072,136 |
Stock-based compensation expense | 4,857,230 | 2,487,730 |
Changes in assets and liabilities: | ' | ' |
Accounts receivable | 2,588,811 | -364,636 |
Inventory | -2,023,786 | ' |
Prepaid expenses and other assets | -804,738 | -131,660 |
Accounts payable and accrued liabilities | 2,977,872 | 299,974 |
Income tax payable | ' | 85,000 |
Deferred revenue | 2,282,208 | -5,303,516 |
Net cash flows from operating activities | -10,798,781 | -44,940,535 |
Investing activities: | ' | ' |
Purchase of equipment | -1,553,583 | -5,521 |
Net cash flows from investing activities | -1,553,583 | -5,521 |
Financing activities: | ' | ' |
Proceeds from sale of common stock | 70,717,786 | ' |
Proceeds from exercise of stock options | 4,572,919 | 347,434 |
Proceeds from notes payable and warrants | 0 | 20,000,000 |
Deferred financing fees | ' | -224,917 |
Proceeds from exercise of common stock warrants | 4,930,796 | ' |
Payment of notes payable | -5,333,333 | ' |
Return of short swing profits | 82,337 | ' |
Change in amounts due to related parties | ' | -69,706 |
Net cash flows from financing activities | 74,970,505 | 20,052,811 |
Net change in cash and cash equivalents | 62,618,141 | -24,893,245 |
Cash and cash equivalents at beginning of period | 23,175,809 | 63,189,307 |
Cash and cash equivalents at end of period | $85,793,950 | $38,296,062 |
Basis_of_presentation
Basis of presentation | 9 Months Ended |
Sep. 30, 2014 | |
Accounting Policies [Abstract] | ' |
Basis of presentation | ' |
1. Basis of presentation: | |
Overview: | |
The accompanying unaudited condensed consolidated financial statements of BioDelivery Sciences International, Inc., a Delaware corporation, together with its wholly-owned subsidiaries, Arius Pharmaceuticals, Inc., a Delaware corporation (“Arius One”), and Arius Two, Inc., a Delaware corporation (“Arius Two”), and its majority-owned, inactive subsidiary, Bioral Nutrient Delivery, LLC, a Delaware limited liability company (“BND”, together with Arius One and Arius Two, collectively, the “Company” or “we”, “us” or similar terminology) have been prepared by the Company without audit. In the opinion of management, all adjustments (which include normal recurring adjustments) necessary to present fairly the financial position, results of operations and cash flows at September 30, 2014, and for all periods presented, have been made. All intercompany accounts and transactions have been eliminated. | |
Certain information and note disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) have been condensed or omitted pursuant to the Securities and Exchange Commission (“SEC”) rules and regulations. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2013, which are included in the Company’s 2013 Annual Report on Form 10-K, filed with the SEC on March 14, 2014 (the “2013 Annual Report”). The accompanying condensed consolidated balance sheet at December 31, 2013 has been derived from the audited financial statements at that date, but does not include all information and notes required by GAAP for complete financial statements. The Company has reclassified certain amounts within expenses in the Statements of Operations for the three and nine month periods ended September 30, 2013 as well as certain amounts within cash flows from operating activities in the Statements of Cash Flows for the nine months ended September 30, 2013 to conform to the current year presentation. These reclassifications had no effect on the measurement of total expenses, loss from operations, or net loss attributable to common stockholders or aggregate cash flows from operating, investing or financing activities. | |
The Company is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. The Company is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction. | |
The Company’s franchise currently consists of four products or product candidates, three of which utilize the Company’s patented BioErodible MucoAdhesive (“BEMA”) drug delivery technology, a thin film applied to the inner lining of the cheek. ONSOLIS® (fentanyl buccal soluble film) is approved in the U.S., Canada, EU (where it is marketed as BREAKYL™) and Taiwan (where it is marketed as PAINKYL™), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights to ONSOLIS® are licensed to Meda AB (“Meda”) for all territories worldwide except for Taiwan (licensed to TTY Biopharm Co. Ltd. (“TTY”)) and South Korea (licensed to Kunwha Pharmaceutical Co., Ltd. (“Kunwha”)). | |
The Company’s second product using the BEMA® technology is BUNAVAIL™ (buprenorphine and naloxone) buccal film, which was approved by the U.S. Food and Drug Administration (“FDA”) in June 2014 for the maintenance treatment of opioid dependence. The Company is commercializing BUNAVAIL™ with a launch scheduled for fourth quarter 2014. As with all other buprenorphine containing products for opioid dependence, the approval of BUNAVAIL™ carries a standard post-approval requirement by the FDA to conduct a study to determine the effect of BUNAVAIL™ on QT prolongation (i.e., an abnormal lengthening of the heartbeat). The clinical study results must be reported to the FDA by the end of 2016. | |
The Company’s third product using the BEMA® technology, BEMA® Buprenorphine, is for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate and is licensed on a worldwide basis to Endo Health Solutions, Inc. (“Endo”). Positive study results for two pivotal Phase 3 trials for this product were reported by the Company in January and July 2014. In August 2014, the Company announced that, along with Endo, it engaged in a positive pre-New Drug Application (“NDA”) meeting with the FDA regarding its BEMA® Buprenorphine product. | |
The Company’s fourth product is Clonidine Topical Gel, which is currently in Phase 3 development for the treatment of painful diabetic neuropathy (“PDN”), which was licensed from Arcion Therapeutics, Inc. (“Arcion”) in March 2013. In June 2014, the Company announced the completion of patient enrollment for the Company’s Phase 3 study of Clonidine Topical Gel. In August 2014, the Company announced that it had completed a pre-specified interim analysis of the ongoing initial pivotal Phase 3 trial for Clonidine Topical Gel. | |
The results of operations for the three and nine month periods ended September 30, 2014 are not necessarily indicative of results that may be expected for any other interim period or for the full fiscal year. Readers of this Quarterly Report are strongly encouraged to review the risk factors relating to the Company which are set forth in the 2013 Annual Report. | |
BDSI® and BEMA® are registered trademarks of the Company. The BioDelivery Sciences logo and BUNAVAIL™ are trademarks owned by the Company. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL™ is a trademark owned by Meda Pharma GmbH & Co. KG. PAINKYL™ is a trademark owned by TTY Biopharm. All other trademarks and tradenames are owned by their respective owners. | |
As used herein, the term “Common Stock” means the Company’s common stock, par value $.001 per share. | |
Fair value of financial assets and liabilities: | |
The Company measures the fair value of financial assets and liabilities in accordance with GAAP which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. | |
GAAP defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. GAAP also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. GAAP describes three levels of inputs that may be used to measure fair value: | |
Level 1 – quoted prices in active markets for identical assets or liabilities | |
Level 2 – quoted prices for similar assets and liabilities in active markets or inputs that are observable | |
Level 3 – inputs that are unobservable (for example cash flow modeling inputs based on assumptions) | |
Inventory | |
The Company utilizes contract manufacturers in all phases of the creation of BUNAVAIL™. At September 30, 2014, inventory includes the cost of raw materials, work in process and finished goods at the Company’s contract manufacturer and third party logistics provider related to the pending launch of BUNAVAIL™. Inventory is stated at the lower of cost or market using the specific identification method, and cost is determined on a first-in, first-out basis. As of September 30, 2014, inventory is composed of $0.4 million of raw materials, $0.3 million of work in process and $1.3 million of finished goods. | |
Equipment | |
Office and Manufacturing equipment are carried at cost less accumulated depreciation, which is computed on a straight-line basis over their estimated useful lives, generally three to ten years. | |
Due to the postponement of the U.S. re-launch of ONSOLIS® (see note 3), related manufacturing equipment, net, totaling $2.7 million has been deemed idle, and has been reclassified to idle equipment, net in the accompanying condensed consolidated balance sheets. The Company evaluates the carrying value of the idle equipment when events or changes in circumstances indicate the related carrying amount may not be recoverable. The Company has not recorded any impairment of this equipment during the nine months ended September 30, 2014. | |
Recent accounting pronouncements: | |
In May 2014, the Financial Accounting Standards Board issued Accounting Standards Update 2014-09, “Revenue from Contracts with Customers,” which supersedes the revenue recognition requirements of Accounting Standards Codification (“ASC”) Topic 605, “Revenue Recognition” and most industry-specific guidance on revenue recognition throughout the ASC. The new standard is principles-based and provides a five step model to determine when and how revenue is recognized. The core principle of the new standard is that revenue should be recognized when a company transfers promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. The new standard also requires disclosure of qualitative and quantitative information surrounding the amount, nature, timing and uncertainty of revenues and cash flows arising from contracts with customers. The new standard will be effective for the Company in the first quarter of the year ending December 31, 2017 and can be applied either retrospectively to all periods presented or as a cumulative-effect adjustment as of the date of adoption. Early adoption is not permitted. The Company is currently evaluating the impact of adoption of the new standard on its consolidated financial statements. |
Liquidity_and_managements_plan
Liquidity and management's plans | 9 Months Ended | |||
Sep. 30, 2014 | ||||
Accounting Policies [Abstract] | ' | |||
Liquidity and management's plans | ' | |||
2. Liquidity and management’s plans: | ||||
Since inception, the Company has financed its operations principally from the sale of equity securities, proceeds from short-term borrowings or convertible notes, funded research arrangements and revenue generated as a result of its worldwide license and development agreement with Meda regarding ONSOLIS® and revenue generated as a result of its January 2012 agreement with Endo regarding its BEMA® Buprenorphine product candidate. The Company intends to finance its research and development, commercialization and working capital needs from existing cash, royalty revenue, potential sales revenue from the commercialization of BUNAVAIL™, new sources of debt and equity financing, existing and new licensing and commercial partnership agreements and, potentially, through the exercise of outstanding Common Stock options and warrants to purchase Common Stock. | ||||
Significant new financing and operating sources during the nine months ended September 30, 2014 consisted of: | ||||
• | approximately $58.2 million in net proceeds from certain institutional investors related to a definitive securities purchase agreement (see note 9); | |||
• | approximately $12.5 million in net proceeds from an “at-the-market” offering program utilizing the Company’s universal shelf registration (see note 9); | |||
• | approximately $22.3 million in contract revenue under the Endo agreement (see note 4); | |||
• | approximately $12.1 million in research and development reimbursements under the Endo agreement (see note 4); | |||
• | approximately $4.6 million from the exercise of stock options; and | |||
• | approximately $4.9 million from the exercise of warrants. | |||
Significant new financing and operating sources during the year ended December 31, 2013 consisted of: | ||||
• | approximately $19.8 million in net proceeds from a secured loan facility from MidCap Financial SBIC, LP, as agent and lender (“MidCap”) (see note 7); | |||
• | approximately $2.8 million in research and development reimbursements under the Endo agreement; | |||
• | approximately $1.8 million in net royalties under the Meda agreements; | |||
• | approximately $0.3 million in contract revenue from licensing and supply agreement (see note 6); and | |||
• | approximately $0.4 million from the exercise of stock options and warrants. | |||
At September 30, 2014, the Company had cash and cash equivalents of approximately $85.8 million. The Company used $10.8 million of cash from operations during the nine months ended September 30, 2014. The Company believes that existing cash as of the date of this Quarterly Report, combined with anticipated revenues associated with the commercialization of BUNAVAIL™ and anticipated regulatory milestone payments from Endo relating to BEMA® Buprenorphine will be sufficient to fully fund the Company’s planned level of operations through the end of 2015. Included in the Company’s planned level of operations are: (i) commercialization activities for BUNAVAIL™ (ii) support of Endo’s activities with BEMA® Buprenorphine relating to NDA compilation, submission and review, (iii) the clinical development of Clonidine Topical Gel, (iv) the final regulatory activities required for the resubmission of ONSOLIS® regulatory package for product reintroduction and (v) funding of general working capital requirements. Additional capital may be required to support these efforts as well as potential new product acquisitions or in-licenses, and the ability to scale up or reduce personnel and associated costs are factors considered by management throughout the product development and commercialization life cycle. However, available capital may be consumed more rapidly than currently anticipated, resulting in the need for additional funding, and there is a risk that additional funding, when and if required, may not be available at commercially favorable terms, if at all. |
Meda_License_Development_and_S
Meda License, Development and Supply Agreements | 9 Months Ended |
Sep. 30, 2014 | |
Text Block [Abstract] | ' |
Meda License, Development and Supply Agreements | ' |
3. Meda License, Development and Supply Agreements: | |
In August 2006 and September 2007, the Company entered into certain agreements with Meda to develop and commercialize the ONSOLIS® product, a drug treatment for breakthrough cancer pain delivered utilizing the BEMA® technology. The aforementioned agreements relate to the United States, Mexico and Canada (such agreements, the “Meda U.S. Agreements”) and to certain countries in Europe (such agreements, the “Meda EU Agreements”, together with Meda U.S. Agreements, the “Meda Agreements”). They carry license terms that commence on the date of first commercial sale in each respective territory and end on the earlier of the entrance of a generic product to the market or upon expiration of the patents, which begin to expire in 2020. | |
The Company determined that upon inception of both the U.S. and EU Meda arrangements, all deliverables are to be considered one combined unit of accounting since the fair value of the undelivered license was not determinable and the research and development efforts provided do not have stand-alone value apart from the license. As such, all cash payments from Meda that were related to these deliverables were recorded as deferred revenue. Upon commencement of the license term (date of first commercial sale in each territory), the license and certain deliverables associated with research and development services were deliverable to Meda. The first commercial sale in the U.S. occurred in October 2009. As a result, $59.7 million of the aggregate milestones and services revenue was recognized as revenue. The first commercial sale in a European country occurred in October 2012. As a result, $17.5 million was recognized as revenue, which included $5.0 million in milestones received during the year ended December 31, 2012. At September 30, 2014, there was remaining deferred revenue of $0.9 million which was related to the Meda research and development services. As time progresses, the Company will on a quarterly basis continue to estimate the time required for ongoing obligations, and adjust the remaining deferred revenue accordingly. | |
The Company earns royalties based on a percentage of net sales revenue of the ONSOLIS® product. The Company earned $1.9 million and $1.8 million in product royalty revenue for the nine months ended September 30, 2014 and 2013, respectively. The Company has incurred cost of sales related to the ONSOLIS® product of approximately $1.9 million and $1.7 million for the nine months ended September 30, 2014 and 2013, respectively, which included minimum royalty expenses that the Company is obligated to pay CDC IV, LLC (“CDC”) and NB Athyrium LLC (“Athyrium”) regardless of actual sales. | |
Upon delivery of the license to Meda, the Company determined that each of the undelivered obligations had stand-alone value to Meda as these post-commercialization services encompass additional clinical trials on different patient groups but do not require further product development and these services and product supply obligations can be provided by third-party providers available to Meda. The Company also obtained third-party evidence of fair value for the other research and development services and other service obligations, based on hourly rates billed by unrelated third-party providers for similar services contracted by the Company. The Company has obtained third-party evidence of fair value of the product supply deliverable based on the outsourced contract manufacturing cost charged to the Company from the third-party supplier of the product. The arrangements do not contain any general rights of return. Therefore, the remaining deliverables to the arrangements have been accounted for as three separate units of accounting to include (1) product supply, (2) research and development services for the ONSOLIS® product and (3) the combined requirements related to the remaining other service-related obligations due to Meda to include participation in committees and certain other specified services. The estimated portion of the upfront payments of approximately $1.1 million (under the Meda U.S. Agreements) and $0.1 million (under the Meda EU Agreements) attributed to these other service-related obligations will be recognized as revenue as services are provided through expiration of the license terms, as defined above. | |
The Company has determined that it is acting as a principal under the Meda Agreements and, as such, will record product supply revenue, research and development services revenue and other services revenue amounts on a gross basis in the Company’s consolidated financial statements. | |
On March 12, 2012, the Company announced the postponement of the U.S. re-launch of ONSOLIS® following the initiation of the class-wide Risk Evaluation and Mitigation Strategy (“REMS”) until the product formulation could be modified to address two appearance-related issues raised by the FDA during an inspection of the manufacturing facility of the Company’s North American manufacturing partner for ONSOLIS®, Aveva Drug Delivery Systems, Inc. (“Aveva”). Specifically, the FDA identified the formation of microscopic crystals and a fading of the color in the mucoadhesive layer during the 24-month shelf life of the product. While these changes do not affect the product’s underlying integrity, safety or performance, the FDA believes that the fading of the color in particular may potentially confuse patients, necessitating a modification of the product and product specification before additional product can be manufactured and distributed. | |
The source of microcrystal formation and the potential for fading of ONSOLIS® was found to be specific to a buffer used in its formulation. This buffer and the coloring agent have both been removed in the reformulated product. As such, the Company believes the appearance issues have been resolved. The Company now has 9 months of product stability data on this formulation that shows no signs of microcrystal formation or color changes. The Company has prepared the necessary regulatory documentation that it believes the FDA will need to approve this change. The Company is working with its commercial partner, MEDA, who is responsible for the NDA and all regulatory filings including the one involving this matter. MEDA is in control of determining when this documentation will be submitted to the FDA. Once submitted, the FDA’s review of the application may take up to 6 months. | |
On May 21, 2012, the Company announced receipt of a pre-launch milestone payment of $2.5 million from Meda in conjunction with the first country registration and pricing approval for BREAKYL™. A final milestone payment related to the EU of $2.5 million was received at the time of commercial launch, which occurred in October 2012. BREAKYL™ is commercialized in the EU by Meda. | |
On September 13, 2012, the Company executed a Manufacturing, Supply, and License Agreement, effective April 26, 2012, with Lohmann Therapie-Systeme AG (“LTS”), under which LTS will manufacture and supply the Company its BREAKYL™ product for distribution outside of the U.S. and Canada. The Company is required to supply the BREAKYL™ product to Meda, Kunwha and TTY pursuant to its obligations under certain license and supply agreements under which Meda, Kunwha, and TTY develop and commercialize the BREAKYL™ product. In conjunction with the agreement, LTS has waived all royalties on products that it will produce. This does not preclude royalties that the Company would owe to LTS if the Company produces BREAKYL™ with another company. |
Endo_License_and_Development_A
Endo License and Development Agreement | 9 Months Ended | |||
Sep. 30, 2014 | ||||
Text Block [Abstract] | ' | |||
Endo License and Development Agreement | ' | |||
4. Endo License and Development Agreement: | ||||
In January 2012, the Company entered into a License and Development Agreement (the “Endo Agreement”) with Endo pursuant to which the Company granted to Endo an exclusive commercial world-wide license to develop, manufacture, market and sell the Company’s BEMA® Buprenorphine product and to complete U.S. development of such product candidate for purposes of seeking FDA approval. | ||||
Pursuant to the Endo Agreement, Endo has obtained all rights necessary to complete the clinical and commercial development of BEMA® Buprenorphine and to sell the product worldwide. Although Endo has obtained all such necessary rights, the Company has agreed under the Endo Agreement to be responsible for the completion of certain clinical trials regarding BEMA® Buprenorphine (and providing clinical trial materials for such trials) necessary to submit a NDA to the FDA in order to obtain approval of BEMA® Buprenorphine in the U.S., in each case pursuant to a development plan set forth in the Endo Agreement (as it may be amended pursuant to the Endo Agreement). The Company is responsible for development activities through the filing of the NDA in the U.S., while Endo is responsible for the development following the NDA submission as well as the manufacturing, distribution, marketing and sales of BEMA® Buprenorphine on a worldwide basis. In addition, Endo is responsible for all filings required in order to obtain regulatory approval of BEMA® Buprenorphine. | ||||
Pursuant to the Endo Agreement, the Company has received (or expects to receive upon satisfaction of applicable conditions) the following payments (some portion(s) of which will be utilized by the Company to support its development obligations under the Endo Agreement with respect to BEMA® Buprenorphine): | ||||
• | $30 million non-refundable upfront license fee (received January 17, 2012); | |||
• | $15 million for enhancement of intellectual property rights (earned in May 2012); | |||
• | $20 million for full enrollment in two clinical trials ($10 million earned in January 2014 and $10 million earned in June 2014); | |||
• | $10 million upon FDA acceptance of filing NDA; | |||
• | up to $50 million upon regulatory approval; | |||
• | up to an aggregate of $55 million based on the achievement of four separate post-approval sales thresholds; and | |||
• | sales-based royalties in a particular percentage range on U.S. sales of BEMA® Buprenorphine, and royalties in a lesser range on sales outside the United States, subject to certain restrictions and adjustments. | |||
The Company has assessed its arrangement with Endo and the Company’s deliverables thereunder at inception to determine: (i) the separate units of accounting for revenue recognition purposes, (ii) which payments should be allocated to which of those units of accounting and (iii) the appropriate revenue recognition pattern or trigger for each of those payments. The assessment requires subjective analysis and requires management to make judgments, estimates and assumptions about whether deliverables within multiple-element arrangements are separable and, if so, to determine the amount of arrangement consideration to be allocated to each unit of accounting. | ||||
At the inception of the Endo arrangement, the Company determined that the Endo Agreement is a multi-deliverable arrangement with three deliverables: (1) the license rights related to BEMA® Buprenorphine, (2) services related to obtaining enhanced intellectual property rights through the issuance of a particular patent and (3) clinical development services. The Company concluded that the license delivered to Endo at the inception of the Endo Agreement has stand-alone value because Endo obtained, at the inception of the Endo Agreement, all of the rights and knowledge necessary to fully exploit its license without the Company’s further involvement. It was also determined that there was a fourth deliverable, the provision of clinical trial material (“CTM”). The amounts involved are, however, immaterial and delivered in essentially the same time frame as the clinical development services. Accordingly, the Company has not separately accounted for the CTM deliverable, but considers it part of the clinical development services deliverable. | ||||
The initial non-refundable $30 million license fee was allocated to each of the three deliverables based upon their relative selling prices using best estimates. The analysis of the best estimate of the selling price of the deliverables was based on the income approach, the Company’s negotiations with Endo and other factors, and was further based on management’s estimates and assumptions which included consideration of how a market participant would use the license, estimated market opportunity and market share, the Company’s estimates of what contract research organizations would charge for clinical development services, the costs of clinical trial materials and other factors. Also considered were entity specific assumptions regarding the results of clinical trials, the likelihood of FDA approval of the subject product and the likelihood of commercialization based in part on the Company’s prior agreements with the BEMA® technology. | ||||
Based on this analysis, $15.6 million of the up-front license fee was allocated to the license (which was estimated to have a value significantly in excess of $30 million), and $14.4 million to clinical development services (which is inclusive of the cost of CTM). Although the intellectual property component was considered a separate deliverable, no distinct amount of the up-front payment was assigned to this deliverable because the Company determined the deliverable to be perfunctory. The amount allocated to the license was recognized as revenue in January 2012. The portion of the upfront license fee allocated to the clinical development services deliverable of $14.4 million is being recognized as those services are performed. The Company estimates that such clinical development services will extend into the first half of 2015. Based on the estimated proportion of those services performed through September 30, 2014, $5.2 million was recognized as revenue in fiscal year 2012, $6.3 million was recognized as revenue in fiscal year 2013 and $2.3 million was recognized as contract revenue during the nine months ended September 30, 2014 in the accompanying condensed statements of operations. As a result, $0.6 million remains deferred at September 30, 2014. | ||||
The Company analyzed the milestone payments noted above to determine if such milestones are substantive. This determination included an analysis of the Company’s performance to achieve each milestone, the enhancement of value of the delivered items, the timing of performance related to the milestone, and the reasonability of the milestone relative to all the deliverables and payment terms. The Company concluded that each of the milestones is substantive and therefore has and will recognize revenue when milestones are earned. | ||||
The term of the Endo Agreement shall last, on a country-by-country basis, until the later of: (i) 10 years from the date of the first commercial sale of BEMA® Buprenorphine in a particular country or (ii) the date on which the last valid claim of the Company’s patents covering BEMA® Buprenorphine in a particular country has expired or been invalidated. The Endo Agreement shall be subject to termination: (i) by Endo, at any time, upon a specific timeframe of prior written notice to the Company, (ii) by Endo and the Company upon mutual written agreement, (iii) by either party upon a material default or breach of the Endo Agreement and such default or breach is not cured within a specified timeframe, (iv) the voluntary or involuntary bankruptcy of either party or (v) by the Company if Endo does not meet certain diligence obligations outside of the United States. | ||||
On February 16, 2012, the Company announced that the U.S. Patent and Trademark Office issued a Notice of Allowance regarding its patent application (No. 13/184306), which patent will extend the exclusivity of the BEMA® drug delivery technology for the Company’s BEMA® Buprenorphine and BUNAVAIL™ product candidates from 2020 to 2027. On April 17, 2012, the Company announced that this patent was granted. As a result, pursuant to the Endo Agreement, the Company received a milestone payment from Endo in the amount of $15 million in May 2012. As discussed above, this milestone had been evaluated to be a substantive milestone, and therefore was recognized as revenue when the milestone was earned. | ||||
On January 23, 2014, the Company announced positive top-line results from its pivotal Phase 3 efficacy study of BEMA® Buprenorphine in opioid-“naive” subjects. The locking of the database for the opioid naive study has triggered a $10 million milestone payment from Endo per the Company’s licensing agreement. Such payment was received during February 2014 and has been recorded as contract revenue in the accompanying 2014 condensed consolidated statement of operations. | ||||
On June 25, 2014, the database for the pivotal Phase 3 efficacy study of BEMA® Buprenorphine in opioid-experienced patients was locked. As a result, the locking of the database triggered a $10 million milestone payment from Endo per the Company’s license agreement. Such payment was received during July 2014 and has been recorded as contract revenue in the accompanying 2014 condensed consolidated statement of operations. | ||||
In August 2014, the Company announced that along with Endo, it engaged in a positive pre-NDA meeting with the FDA regarding the BEMA® Buprenorphine product. | ||||
The remaining milestone payments are expected to be recognized as revenue as they are achieved, except that one milestone is contingently refundable for a period of time. Revenue related to such contingently refundable milestone is expected to be recognized as refund provisions, as defined in the agreement, expire. Sale threshold payments and sales-based royalties will be recognized as they occur under the terms of the Endo Agreement. | ||||
The Company is reimbursed by Endo for certain contractor costs when these costs go beyond set thresholds as outlined in the Endo Agreement. Endo reimburses the Company for this spending at cost and the Company receives no mark-up or profit. The gross amount of these reimbursed research and development costs are reported as research and development reimbursement revenue in the accompanying consolidated statements of operations. The Company acts as a principal, has discretion to choose suppliers, bears credit risk and may perform part of the services required in the transactions. Therefore, these reimbursements are treated as revenue to the Company. The actual expenses creating the reimbursements are reflected as research and development expense. | ||||
Beginning in March 2014, total reimbursable contractor costs exceeded a set threshold, at which point all such expenses are to be borne at a rate of 50% by Endo and 50% by the Company. In connection with the Endo Agreement, Endo has continued to reimburse the Company for 100% of such costs, with 50% thereof to be taken as a credit against potential future milestones associated with achievement of certain regulatory events. At September 30, 2014, the Company has recorded $4.8 million of such prepayments, as deferred revenue, long term in the accompanying condensed consolidated balance sheet. During the nine months ended September 30, 2014, the Company recognized $12.1 million of reimbursable expenses related to its Endo agreement, which is recorded as revenue and shown as research and development reimbursements on the accompanying condensed consolidated statements of operations. |
Arcion_License_Agreement
Arcion License Agreement | 9 Months Ended | |||
Sep. 30, 2014 | ||||
Text Block [Abstract] | ' | |||
Arcion License Agreement | ' | |||
5. Arcion License Agreement: | ||||
On March 26, 2013, the Company entered into a definitive Exclusive License Agreement (the “Arcion Agreement”) with Arcion pursuant to which Arcion agreed to grant to the Company an exclusive commercial world-wide license, with rights of sublicense, under certain patent and other intellectual property rights related to in-process research and development to develop, manufacture, market, and sell gel products containing clonidine (or a derivative thereof), alone or in combination with other active ingredients, for topical administration for the treatment of PDN and other indications (the “Arcion Products”). | ||||
Pursuant to the Arcion Agreement, the Company is responsible for using commercially reasonable efforts to develop and commercialize Arcion Products, including the use of such efforts to conduct certain clinical trials within certain time frames. | ||||
Upon execution of the Arcion Agreement, the Company issued to Arcion 500,516 unregistered shares of Common Stock with a fair market value of $2.1 million, which shares are subject to a nine month lock-up and certain limitations on sales thereafter. The issuance of such shares (delivered April 2013) was exempt from registration under the Securities Act of 1933, as amended, in reliance on Section 4(2) thereof. In addition, the Company is required to make the following payments to Arcion: | ||||
• | $2.5 million upon filing and acceptance by the FDA of an NDA with respect to an Arcion Product, payable at the Company’s option, in cash or unregistered shares of Common Stock (with such shares also being subject to a nine month lock-up and certain limitations on sale thereafter); and | |||
• | up to a potential $60 million in cash payments upon achieving certain pre-determined sales thresholds in the U.S., none of which occur prior to achieving at least $200 million in U.S. net sales. | |||
In addition, the Company shall pay Arcion $35 million in cash on initial FDA approval of an Arcion Product, unless: (i) the Company does not receive at least $70 million in FDA approval-related milestone payments from its US sublicensees (if any sublicenses are involved) with respect to the Arcion Product, in which case the Company shall pay Arcion a prorated amount between $17.5 million and $35 million based on the total amount of such milestone payments received by the Company and its affiliates from its sublicenses (if any sublicenses are involved); or (ii) the FDA requires or recommends the performance of a capsaicin challenge test as a precondition or precursor to the prescribing of the Arcion Product (as a condition of approval, a labeling requirement, or otherwise), in which case such milestone shall be reduced to $17.5 million, but the first and second sales threshold payments described above shall each be increased by $8 million. | ||||
All milestone payments due to Arcion under the Arcion Agreement are payable only once each. | ||||
In addition to the milestones set forth above, the Company will pay Arcion: | ||||
• | a low single digit royalty on the Company’s and its affiliates’ net sales of Arcion Products in the U.S.; | |||
• | a low double digit percentage of all sales-based payments received by the Company and its affiliates with respect to sublicensees’ sales of Arcion Products in the U.S.; | |||
• | a low single digit royalty on all net sales of Arcion Products outside the U.S.; and | |||
• | a low double digit percentage of all milestone payments received by the Company and its affiliates from their sublicensees that are triggered by the receipt of regulatory approval of the Arcion Product in certain jurisdictions outside of the U.S. | |||
The aforementioned sales royalties are subject to certain reductions, on a country-by-country and product-by-product basis, under certain agreed upon circumstances. In addition, in the event the amount due upon FDA approval of the Arcion Product in the U.S. is less than $35 million for any reason other than an FDA requirement or recommendation of a capsaicin challenge test, as described above, the Company shall pay Arcion a portion of any milestone payments received by the Company and its affiliates from their sublicensees on the basis of any events occurring in the U.S. following FDA approval but prior to (and including) first commercial sale of an Arcion Product in the U.S., and certain of the payments to Arcion referred to above shall also be subject to upward adjustment (with such upward adjustments payable in the form of cash or unregistered shares of the Company’s Common Stock, as elected solely by the Company), until such time as the sum of all such additional payments and upward adjustments (including the value of any issuances of stock, if elected by the Company) and the initial amount paid on the initial FDA approval totals $35 million. | ||||
The term of the Arcion Agreement continues, on a country-by-country and product-by-product basis, until the earlier of (i) the expiration of the royalty term for a particular Arcion Product in a particular country or (ii) the effective date of termination by either party pursuant to customary termination provisions. The royalty term for any given country is the later of (i) the first date there are no valid claims against any Arcion patent, (ii) expiration of patent exclusivity or (iii) tenth anniversary of the first commercial sale. Further, the Company may, in its sole discretion, terminate the Arcion Agreement upon certain notice to Arcion. Upon expiration of the Agreement pursuant to clause (i) above with respect to a particular Arcion Product and country, the Company and its affiliates shall have the perpetual, unrestricted, irrevocable, fully-paid, royalty-free exclusive right, with rights of sublicense, to make, have made, use, sell, offer for sale, and import such Arcion Product in such country. | ||||
In conjunction with this transaction, the March 2013 payment to Arcion of $2.1 million in unregistered Common Stock was for in-process research and development and has been recorded as research and development expense in the accompanying condensed consolidated statement of operations for the nine months ended September 30, 2013. | ||||
On April 3, 2014, the Company announced the enrollment of the first patient in the RHAPSODY Study, a Phase 3 clinical trial of the Clonidine Topical Gel for the treatment of painful diabetic neuropathy. On June 26, 2014, the Company announced that it completed randomization of all patients required based on the initial planned sample size for the study. | ||||
On August 6, 2014, the Company announced that it has completed a pre-specified interim analysis. The purpose of the interim analysis was to allow for a sample size adjustment if necessary to maintain appropriate statistical power to detect a treatment effect between Clonidine Topical Gel and placebo. As a result of the interim analysis, a total of approximately 80 additional patients will be added to the ongoing trial in an effort to maintain 90% power to detect a statistically significant difference between Clonidine Topical Gel and placebo. | ||||
This will extend patient enrollment until year-end with top-line results expected near the end of the first quarter of 2015. |
Other_License_Agreements_and_A
Other License Agreements and Acquired Product Rights | 9 Months Ended |
Sep. 30, 2014 | |
Goodwill and Intangible Assets Disclosure [Abstract] | ' |
Other License Agreements and Acquired Product Rights | ' |
6. Other License Agreements and Acquired Product Rights: | |
Kunwha License Agreement | |
In May 2010, the Company entered into a License and Supply Agreement (the “Kunwha License Agreement”) with Kunwha to develop, manufacture, sell and distribute the Company’s BEMA® Fentanyl product in the Republic of Korea (the “Kunwha Territory”). BEMA® Fentanyl is marketed as ONSOLIS® in North America. The Kunwha License Agreement is for a term beginning on May 26, 2010 until the expiration of the patents, or July 23, 2027, whichever is later. | |
Under the terms of the Kunwha License Agreement, Kunwha was granted exclusive licensing rights for BEMA® Fentanyl in the Kunwha Territory, while the Company will retain all other licensing rights to the Licensed Product not previously granted to third parties. Kunwha paid to the Company an upfront payment of $0.3 million (net of taxes approximating $0.25 million) and will be responsible to make certain milestone payments which could aggregate up to $1.3 million (net of taxes approximating $1.1 million). | |
In addition, Kunwha will pay royalties to the Company based on Net Sales (as defined in the Kunwha License Agreement) and will purchase all supplies of BEMA® Fentanyl from the Company. | |
Kunwha will be responsible for payment of all costs associated with BEMA® Fentanyl in the Kunwha Territory. Kunwha and the Company will own any Improvements (as defined in the Kunwha License Agreement) made exclusively by such party with respect to BEMA® Fentanyl and will jointly own any Improvements that are the product of collaboration. | |
TTY License and Supply Agreement | |
On October 7, 2010, the Company announced a license and supply agreement with TTY for the exclusive rights to develop and commercialize BEMA® Fentanyl in the Republic of China, Taiwan. The agreement results in potential milestone payments to the Company of up to $1.3 million, which includes an upfront payment of $0.3 million, which was recorded as contract revenue in 2010. In addition, the Company will receive an ongoing royalty based on net sales. TTY will be responsible for the regulatory filing of BEMA® Fentanyl in Taiwan as well as future commercialization in that territory. The term of the agreement with TTY is for the period from October 4, 2010 until the date 15 years after first commercial sale unless the agreement is extended in writing or earlier terminated as provided for in the agreement. | |
On November 7, 2011, the Company announced that TTY had submitted an NDA for marketing authorization of BEMA® Fentanyl to the Taiwan Food and Drug Administration. This triggered a milestone payment to the Company of approximately $0.3 million, which was received November 2011 and recorded as contract revenue in 2011. | |
On July 29, 2013, the Company announced the regulatory approval of BEMA® Fentanyl in Taiwan, where the product will be marketed under the brand name PAINKYL™. The approval in Taiwan resulted in a milestone payment of $0.3 million to the Company, which was received in the third quarter 2013 and recorded as contract revenue in 2013. |
MidCap_Secured_Loan_Facility
MidCap Secured Loan Facility | 9 Months Ended | ||||
Sep. 30, 2014 | |||||
Debt Disclosure [Abstract] | ' | ||||
MidCap Secured Loan Facility | ' | ||||
7. MidCap Secured Loan Facility: | |||||
On July 5, 2013, the Company entered into a $20 million secured loan facility (the “Loan Transaction” and such loan, the “Loan”) with MidCap as agent and lender pursuant to the terms and conditions of the Credit and Security Agreement, dated as of July 5, 2013 (as amended on July 3, 2014 with an effective date of June 29, 2014), among the Borrowers and MidCap (the “Credit Agreement”). The Company received net proceeds in the aggregate amount of $19.8 million and has and will use the Loan proceeds for general corporate purposes or other activities of the Borrower permitted under the Credit Agreement. | |||||
In addition, pursuant to the Loan Transaction, the Company issued to MidCap a warrant (the “MidCap Warrant”) to purchase 357,356 unregistered shares of Common Stock, which warrant has an exercise price of $4.20 per share, the 20-day volume-weighted average share price of the Common Stock prior to the closing of the Loan. The MidCap Warrant is exercisable for a term of five years and contains cashless exercise provisions and customary, anti-dilution protection provisions. The proceeds of the secured loan facility were allocated to the note payable and Midcap warrants (which qualified for equity accounting) based on their relative fair values, as follows: | |||||
Note payable | $ | 19,013,648 | |||
MidCap warrant | 986,352 | ||||
Total proceeds | $ | 20,000,000 | |||
The resulting debt discount is being amortized to interest expense over the 3 year life of the loan. | |||||
The fair value of the warrants was determined based upon the Black Scholes valuation model using the following key assumptions: | |||||
Market price of stock | $ | 4.41 | |||
Term of warrant | 5 years | ||||
Volatility | 81.05 | % | |||
Risk free interest rate | 2.9 | % | |||
The Loan has a term of 36 months with interest only payments until February 1, 2014. The interest rate is 8.45% plus a LIBOR floor of 0.5% (total of 8.95% at September 30, 2014 and December 31, 2013). Upon execution of the Credit Agreement, the Company paid to MidCap a closing fee of 0.5% of the aggregate Loan amount. Upon repayment in full of the Loan, the Company is obligated to make a final payment fee equal to 3.5% of the aggregate Loan amount. The 3.5% exit fee has been recorded as deferred loan costs, the current portion of which is included in prepaid expenses and other current assets and the long-term portion in other assets. Additionally, the liability associated with the exit fee has been recorded in other long-term liability in the accompanying condensed consolidated balance sheets. The assets associated with this exit fee are accreted to interest expense through the maturity of the Midcap Loan. In addition, the Company may prepay all or any portion of the Loan at any time subject to a prepayment premium of: (i) 5% of the Loan amount prepaid in the first year of the Loan and (ii) 3% of the Loan amount prepaid in each year thereafter. | |||||
The obligations of the Borrowers under the Credit Agreement are secured by a first priority lien in favor of MidCap on substantially all of the Borrowers’ existing and after-acquired assets, but excluding certain of the Borrowers’ intellectual property and general intangible assets of the Borrowers (but not any proceeds thereof). The obligations of the Company under the Loan Agreement are also secured by a first priority lien on the equity interests held by the Company in Arius One, Arius Two and BND. The Borrowers entered into customary pledge and intellectual property security agreements to evidence the security interest in favor of MidCap. | |||||
Under the Credit Agreement, the Borrowers are subject to affirmative covenants which are customary for financings of this type, including, but not limited to, the obligations of the Borrowers to: (i) maintain good standing and governmental authorizations, (ii) provide certain information and notices to MidCap, (iii) deliver monthly and annual financial statements to MidCap, (iv) maintain insurance, (v) discharge all taxes, (vi) protect their intellectual property and (vii) generally protect the collateral granted to MidCap. | |||||
The Borrowers are also subject to negative covenants customary for financings of this type, including, but not limited to, that without the prior consent of Midcap, they may not: (i) enter into a merger or consolidation or certain change of control events, (ii) incur liens on the collateral, (iii) incur additional indebtedness, (iii) dispose of any property, (iv) amend material agreements or organizational documents, (v) change their jurisdictions of organization or their organizational structures or types, (vi) declare or pay dividends (other than dividends payable solely in Common Stock), (vii) make certain investments or acquisitions, or (viii) enter into certain transactions with affiliates, in each case subject to certain exceptions provided for in the Credit Agreement, including exceptions that allow the Borrowers to acquire additional products and to enter into licenses and similar agreements provided certain conditions are met. | |||||
The Credit Agreement provides that events of default include: (i) failure to make payment of principal or interest on the Loan when required, (ii) failure to perform obligations under the Credit Agreement and related documents, (iii) defaults in other indebtedness and breaches of material agreements of the Borrowers, (iv) if any Borrower shall generally not pay its debts as such debts become due and similar insolvency matters, (v) material adverse changes to the Borrowers (subject to a 10-day notice and cure period), (vi) if the Company ceases to be a publicly-listed and reporting company and (vii) certain other events, including certain adverse actions taken by the Food and Drug Administration or other governmental authorities. Upon an event of default, the Borrower’s obligations under the Credit Agreement may, or in the event of insolvency or bankruptcy will automatically, be accelerated. Upon the occurrence of any event of default, the Borrower’s obligations under the Credit Agreement will bear interest at a rate equal to the lesser of: (i) 4% above the rate of interest applicable to such obligations immediately prior to the occurrence of the event of default or (ii) the maximum rate allowable under law. | |||||
The balance of the secured loan facility due to MidCap as of September 30, 2014 is $14.7 million, and is recorded in the accompanying condensed consolidated balance sheet, net of unamortized discount of $0.6 million. Effective June 29, 2014, the Company and MidCap amended the Credit Agreement to (i) remove the failure to receive the database lock payments by June 30, 2014 as an event of default and (ii) delete the ability of the Company to prepay a portion of the Loan with the database lock payments. | |||||
The following table represents future maturities of the MidCap obligation as of September 30, 2014: | |||||
Years ending September 30, | |||||
2015 | 8,000,000 | ||||
2016 | 6,666,667 | ||||
Total maturities | 14,666,667 | ||||
Unamortized discount | (575,371 | ) | |||
Total Midcap obligation | $ | 14,091,296 | |||
Derivative_Financial_Instrumen
Derivative Financial Instruments | 9 Months Ended | ||||||||||||||||||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||||||||||||||||||
Derivative Instruments and Hedging Activities Disclosure [Abstract] | ' | ||||||||||||||||||||||||||||||||
Derivative Financial Instruments | ' | ||||||||||||||||||||||||||||||||
8. Derivative Financial Instruments: | |||||||||||||||||||||||||||||||||
The Company generally does not use derivative instruments to hedge exposures to cash-flow risks or market-risks that may affect the fair values of its financial instruments. However, certain other financial instruments, such as warrants and embedded conversion features that are indexed to the Company’s Common Stock, are classified as liabilities when either: (a) the holder possesses rights to net-cash settlement or (b) physical or net-share settlement is not within the control of the Company. In such instances, net-cash settlement is assumed for financial accounting and reporting, even when the terms of the underlying contracts do not provide for net-cash settlement. Such financial instruments are initially recorded at fair value estimated on the settlement date using the Black-Scholes valuation model that uses assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate, and then adjusted to fair value at the close of each reporting period. | |||||||||||||||||||||||||||||||||
The following table summarizes assets and liabilities measured at fair value on a recurring basis at September 30, 2014 and December 31, 2013, respectively: | |||||||||||||||||||||||||||||||||
September 30, 2014 | December 31, 2013 | ||||||||||||||||||||||||||||||||
Level | Level | Level | Total | Level | Level | Level | Total | ||||||||||||||||||||||||||
1 | 2 | 3 | 1 | 2 | 3 | ||||||||||||||||||||||||||||
Fair Value | |||||||||||||||||||||||||||||||||
Measurements Using: | |||||||||||||||||||||||||||||||||
Liabilities | |||||||||||||||||||||||||||||||||
Derivative liabilities- free standing warrants | $ | — | $ | 12,579,418 | $ | — | $ | 12,579,418 | $ | — | $ | 4,315,183 | $ | — | $ | 4,315,183 | |||||||||||||||||
The table below provides a reconciliation of the beginning and ending balances for the liabilities measured at fair value using observable inputs (Level 2). The table reflects net gains and losses for all financial liabilities categorized as Level 2 as of September 30, 2014 and December 31, 2013. | |||||||||||||||||||||||||||||||||
$ | Number of | ||||||||||||||||||||||||||||||||
Warrants | |||||||||||||||||||||||||||||||||
Liabilities: | |||||||||||||||||||||||||||||||||
Warrant liability as of December 31, 2013 | $ | 4,315,183 | 1,999,436 | ||||||||||||||||||||||||||||||
Decrease due to exercise of warrants | (6,366,440 | ) | (1,099,011 | ) | |||||||||||||||||||||||||||||
Increase in fair value of warrants | 14,630,675 | — | |||||||||||||||||||||||||||||||
Warrant liability as of September 30, 2014 | $ | 12,579,418 | 900,425 | ||||||||||||||||||||||||||||||
The derivative (loss) gain recognized in the condensed consolidated statements of operations reflects the change in fair value of these warrant liabilities. |
Stockholders_Equity
Stockholders' Equity | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Equity [Abstract] | ' | ||||||||||||||||
Stockholders' Equity | ' | ||||||||||||||||
9. Stockholders’ Equity: | |||||||||||||||||
Stock-based compensation | |||||||||||||||||
During the nine months ended September 30, 2014, a total of 152,265 options to purchase Common Stock with an aggregate fair market value of approximately $1 million were granted to Company employees. The options granted have a term of 10 years from the grant date and vest ratably over a three year period. The fair value of each option is amortized as compensation expense evenly through the vesting period. The fair value of each option award is estimated on the grant date using the Black-Scholes valuation model that uses assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate. Expected volatilities are based on implied volatilities from historical volatility of the Common Stock, and other factors estimated over the expected term of the options. The expected term of options granted is derived using the “simplified method” which computes expected term as the average of the sum of the vesting term plus contract term. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for the period of the expected term. The weighted average for key assumptions used in determining the fair value of options granted during the nine months ended September 30, 2014 follows: | |||||||||||||||||
Expected price volatility | 74.7-78.05 | % | |||||||||||||||
Risk-free interest rate | 1.00-1.58 | % | |||||||||||||||
Weighted average expected life in years | 6 years | ||||||||||||||||
Dividend yield | — | ||||||||||||||||
Option activity during the nine months ended September 30, 2014 was as follows: | |||||||||||||||||
Number of | Weighted | Aggregate | |||||||||||||||
Shares | Average | Intrinsic | |||||||||||||||
Exercise | Value | ||||||||||||||||
Price | |||||||||||||||||
Per Share | |||||||||||||||||
Outstanding at January 1, 2014 | 4,192,927 | $ | 3.82 | ||||||||||||||
Granted in 2014: | |||||||||||||||||
Officers and Directors | — | — | |||||||||||||||
Others | 152,265 | 9.41 | |||||||||||||||
Exercised | (1,337,878 | ) | 3.48 | ||||||||||||||
Forfeitures | — | — | |||||||||||||||
Outstanding at September 30, 2014 | 3,007,314 | $ | 4.26 | $ | 38,598,170 | ||||||||||||
Options outstanding at September 30, 2014 are as follows: | |||||||||||||||||
Range of Exercise Prices | Number | Weighted | Weighted | Aggregate | |||||||||||||
Outstanding | Average | Average | Intrinsic | ||||||||||||||
Remaining | Exercise | Value | |||||||||||||||
Contractual | Price | ||||||||||||||||
Life (Years) | |||||||||||||||||
$1.00 – 5.00 | 2,059,390 | 5.25 | $ | 3.1 | |||||||||||||
$5.01 – 10.00 | 905,344 | 4.01 | $ | 6.44 | |||||||||||||
$10.01-15.00 | 23,744 | 9.82 | $ | 12.44 | |||||||||||||
$15.01-20.00 | 18,836 | 9.99 | $ | 15.95 | |||||||||||||
3,007,314 | $ | 38,598,170 | |||||||||||||||
Options exercisable at September 30, 2014 are as follows: | |||||||||||||||||
Range of Exercise Prices | Number | Weighted | Weighted | Aggregate | |||||||||||||
Exercisable | Average | Average | Intrinsic | ||||||||||||||
Remaining | Exercise | Value | |||||||||||||||
Contractual | Price | ||||||||||||||||
Life (Years) | |||||||||||||||||
$1.00 – 5.00 | 1,725,513 | 4.69 | $ | 2.98 | |||||||||||||
$5.01 – 10.00 | 740,000 | 2.84 | $ | 6.35 | |||||||||||||
$10.01-15.00 | — | ||||||||||||||||
$15.01-20.00 | — | ||||||||||||||||
2,465,513 | $ | 32,321,327 | |||||||||||||||
The weighted average grant date fair value of options granted during the nine months ended September 30, 2014 was $6.77. There were no options granted during the nine months ended September 30, 2014 whose exercise price was lower than the estimated market price of the stock at the grant date. A summary of the status of the Company’s non-vested stock options as of January 1, 2014, and changes during the nine months ended September 30, 2014 is summarized as follows: | |||||||||||||||||
Nonvested Shares | Shares | Weighted | Aggregate | ||||||||||||||
Average | Intrinsic | ||||||||||||||||
Grant Date | Value | ||||||||||||||||
Fair Value | |||||||||||||||||
Nonvested at January 1, 2014 | 614,468 | ||||||||||||||||
Granted | 152,265 | ||||||||||||||||
Vested | (224,932 | ) | |||||||||||||||
Forfeited | — | ||||||||||||||||
Nonvested at September 30, 2014 | 541,801 | $ | 3.33 | $ | 6,276,843 | ||||||||||||
As of September 30, 2014, there was approximately $11.3 million of unrecognized compensation cost related to non-vested share-based compensation awards, including options and restricted stock units (“RSUs”) granted. These costs will be expensed through 2017. | |||||||||||||||||
On July 17, 2014, the Company held its 2014 Annual Meeting of Stockholders (the “Annual Meeting”). During the Annual Meeting, stockholders approved the amendment to the Company’s 2011 Equity Incentive Plan to increase the number of shares of common stock authorized for issuance under the plan by 2,000,000 shares from 6,800,000 to 8,800,000. | |||||||||||||||||
Warrants | |||||||||||||||||
The Company has granted warrants to purchase shares of Common Stock. Warrants may be granted to affiliates in connection with certain agreements. Warrants outstanding at September 30, 2014, all of which are exercisable are as follows: | |||||||||||||||||
Range of Exercise Prices | Number | Weighted | Weighted | Aggregate | |||||||||||||
Outstanding | Average | Average | Intrinsic | ||||||||||||||
Remaining | Exercise | Value | |||||||||||||||
Contractual | Price | ||||||||||||||||
Life (Years) | |||||||||||||||||
$0.01 – 5.00 | 900,425 | 0.56 | $ | 3.12 | $ | 12,578,937 | |||||||||||
During the nine months ended September 30, 2014, approximately 1.1 million shares of Common Stock underlying warrants were exercised for proceeds to the Company of $4.9 million. Also during the nine months ended September 30, 2014, there were 357,356 shares of Common Stock underlying a warrant exercised on a cashless basis, which resulted in a net issuance of 218,367 shares to the warrant holder. | |||||||||||||||||
In October, 2014, 0.6 million shares of Common Stock underlying warrants were exercised for proceeds to the Company of approximately $1.9 million. | |||||||||||||||||
Common Stock | |||||||||||||||||
In November 2013, the Company filed a shelf registration statement which registered up to $75 million of the Company’s securities for potential future issuance, and such registration statement was declared effective on December 18, 2013. Concurrent with the filing of such registration statement, the Company established an “at-the-market” offering program utilizing the universal shelf registration for up to $15 million of Common Stock. Cantor Fitzgerald & Co. is the placement agent for such offering program. In January 2014, the Company sold 658,489 shares of Common Stock under such offering program for approximate net proceeds of $3.9 million. In September and October 2014, the Company sold 529,010 and 116,911 shares of Common Stock, respectively, under such offering program for approximate net proceeds of $8.6 million and $1.9 million, respectively. | |||||||||||||||||
On February 7, 2014, the Company entered into a definitive Securities Purchase Agreement with certain institutional investors relating to a registered direct offering by the Company of 7,500,000 shares of the Company’s Common Stock, par value $.001 per share. The shares were sold at a price of $8.00 per share, yielding net offering proceeds of $58.2 million. The offering price per share was determined based on an approximately 3.1% discount to the closing price of the Common Stock on February 7, 2014. | |||||||||||||||||
During the nine months ended September 30, 2014, Company employees, directors and affiliates exercised approximately 1.3 million stock options, with net proceeds to the Company of approximately $4.6 million. | |||||||||||||||||
Preferred Stock | |||||||||||||||||
The Company has authorized five million “blank check” shares of $.001 par value convertible preferred stock. During the nine months ended September 30, 2014, 570,300 shares of Series A Preferred stock converted to common stock. At September 30, 2014, 2,139,000 shares of Series A Preferred were outstanding. | |||||||||||||||||
Earnings Per Share | |||||||||||||||||
During the nine months ended September 30, 2014 and 2013, outstanding stock options, warrants and convertible preferred stock of 6 million and 9.2 million, respectively, were not included in the computation of diluted earnings per share, because to do so would have had an antidilutive effect. | |||||||||||||||||
Recovery of Stockholder Short Swing Profit | |||||||||||||||||
In February 2014, three executive officers of the Company paid a total of approximately $0.08 million to the Company, representing the disgorgement of short swing profits under Section 16(b) under the Exchange Act. The amount was recorded as additional paid-in capital. | |||||||||||||||||
Restricted Stock Units | |||||||||||||||||
During the nine months ended September 30, 2014, a total of 995,619 RSUs were granted to members of the Company’s senior management, with a fair market value of approximately $8.8 million. The fair value of restricted units is determined using quoted market prices of the Common Stock and the number of shares expected to vest. These RSUs were issued under the Company’s 2011 Equity Incentive Plan, as amended, and vest in equal installments over three years. | |||||||||||||||||
During the nine months ended September 30, 2014, a total of 110,000 RSUs were granted to members of the Company’s board of directors, with a fair market value of approximately $1.5 million. These RSUs were issued under the Company’s 2011 Equity Incentive Plan, as amended, and vest in equal installments over one year. Additionally, there were 15,000 RSUs granted to two new board members, with a market value of approximately $0.2 million. These RSUs were issued under the Company’s 2011 Equity Incentive Plan, as amended, and vest in 2015. | |||||||||||||||||
Also during the nine months ended September 30, 2014, the following RSUs vested; 1) a total of 359,446 RSUs that were previously granted in 2013 to members of the Company’s senior management with a fair market value of approximately $3.2 million, 2) a total of 55,000 RSUs that were previously granted in 2013 to members of the Company’s board of directors with a fair market value of approximately $0.7 million and 3) a total of 55,000 RSUs that were granted in 2014 to members of the Company’s board of directors with a fair market value of approximately $0.7 million. These RSUs were issued under the Company’s 2011 Equity Incentive Plan, as amended. | |||||||||||||||||
Performance Long Term Incentive Plan | |||||||||||||||||
In December 2012, the Company’s Board of Directors (the “Board”) approved the BDSI Performance Long Term Incentive Plan (“LTIP”). The LTIP is designed as an incentive for the Company’s senior management to generate revenue for the Company. The LTIP consists of RSUs (which are referred to in this context as Performance RSUs) which are rights to acquire shares of Common Stock. All Performance RSUs granted under the LTIP will be granted under the Company’s 2011 Equity Incentive Plan (as the same may be amended, supplemented or superseded from time to time) as “Performance Compensation Awards” under such plan. The participants in the LTIP are either named executive officers or senior officers of the Company. | |||||||||||||||||
The term of the LTIP began with the Company’s fiscal year ended December 31, 2012 and lasts through the fiscal year ended December 31, 2019. The total number of Performance RSUs covered by the LTIP is 1,078,000, of which 978,000 were awarded in 2012 (with 100,000 Performance RSUs being reserved for future hires). The Performance RSUs under the LTIP did not vest upon granting, but instead are subject to potential vesting each year over the 8 year term of the LTIP depending on the achievement of revenue by the Company, as reported in its Annual Report on Form 10-K. During the nine months ended September 30, 2014, a total of 4,447 RSUs vested, subject to performance criteria. |
Commitments_and_contingencies
Commitments and contingencies | 9 Months Ended |
Sep. 30, 2014 | |
Commitments and Contingencies Disclosure [Abstract] | ' |
Commitments and contingencies | ' |
10. Commitments and contingencies: | |
Litigation Related To ONSOLIS® | |
In March 2012, the Company announced that the New Jersey Federal Court granted a stay of further litigation in the patent infringement lawsuit previously filed by MonoSol Rx, LLC (“MonoSol”) against the Company and its ONSOLIS® commercial partners. The court ordered that the case would be stayed pending resolution by the United States Patent and Trademark Office (“USPTO”) of reexamination proceedings and follows the recent rejection by the USPTO of all claims in all three patents asserted by MonoSol against the Company and its commercial partners for ONSOLIS®. | |
On March 26, 2014, the Company participated in an oral hearing for the appeal, in which both parties presented arguments before the Patent Trial & Appeal Board (“PTAB”). On April 17, 2014 the PTAB issued a Decision on Appeal affirming the Examiner’s rejection (and confirming the invalidity) of all the claims of the ’588 Patent. MonoSol did not request a rehearing by the May 17, 2014 due date for making such a request and did not appeal the Decision to the Federal Court of Appeals by the June 17, 2014 due date for making such an appeal. Therefore, the Company expects the USPTO to issue a Certificate of Reexamination cancelling the ‘588 Patent claims, which should happen before the end of 2014. | |
Importantly, in the case of MonoSol’s ’588 Patent, at the conclusion of the reexamination proceedings (and its appeals process), on April 17, 2014, the PTAB issued a Decision on Appeal affirming the Examiner’s rejection (and confirming the invalidity) of all the claims of the ’588 Patent. MonoSol did not request a rehearing by the May 17, 2014 due date for making such a request and did not further appeal the Decision to the Federal Court of Appeals by the June 17, 2014 due date for making such an appeal. Subsequently, on August 5, 2014, the USPTO issued a Certificate of Reexamination cancelling the ‘588 Patent claims. | |
Based on the Company’s original assertion that its proprietary manufacturing process for ONSOLIS® does not infringe on patents held by MonoSol, and the denial and subsequent narrowing of the claims on the two reissued patents MonoSol has asserted against the Company while the third has had all claims rejected by the USPTO, the Company remains very confident in its original stated position regarding this matter. Thus far, the Company has proven that the “original” ’292 and ’891 patents in light of their reissuance with fewer and narrower claims were indeed invalid and the third and final patent, the ’588 patent, was invalid as well with all its claims cancelled. Given the outcomes of the ‘292, ‘891 and ‘588 reexamination proceedings, the possibility exists that the stay on the case could be lifted. If this occurs, the Company will continue to defend this case vigorously and seek a dismissal, but ultimately, the Company anticipates that MonoSol’s claims against the Company will be rejected. | |
Litigation Related To BUNAVAILTM | |
On October 29, 2013, Reckitt Benckiser, Inc. RB Pharmaceuticals Limited, and MonoSol RX, LLC (collectively, the “RB Plaintiffs”) filed an action against the Company relating to the Company’s BUNAVAIL™ product in the United States District Court for the Eastern District of North Carolina for alleged patent infringement. BUNAVAIL™ is a proposed treatment for opioid dependence. The RB Plaintiffs claim that the formulation for BUNAVAIL™, which has never been disclosed publicly, infringes its patent (United States Patent No. 8,475,832). The Company strongly refutes as without merit the RB Plaintiffs’ assertion of patent infringement and will vigorously defend the lawsuit. | |
On January 31, 2014, the Company filed in Court a motion for stay pending the outcome of the inter partes review proceedings. The Court scheduled a hearing on the motion to dismiss and motion to stay had been scheduled for April 25, 2014. At the Court hearing, both the RB Plaintiffs and the Company had the opportunity to present arguments to the Court on the pending motions. | |
On May 21, 2014 the Court granted the Company’s motion to dismiss. In doing so, the Court dismissed the case in its entirety. The RB Plaintiffs did not appeal the Court Decision by the June 21, 2014 due date and therefore, the dismissal will stand and the RB Plaintiffs lose the ability to challenge the Court Decision in the future. The possibility exists, however, that the RB Plaintiffs could file another suit alleging infringement of the ‘832 Patent. If this occurs, based on the Company’s original position that its BUNAVAIL™ product does not infringe the ‘832 Patent, the Company would defend the case vigorously (as the Company has done so previously), and the Company anticipates that such claims against the Company ultimately would be rejected. | |
On September 20, 2014, based upon the Company’s position and belief that its BUNAVAIL™ product does not infringe any patents owned by the RB Plaintiffs, the Company proactively filed a declaratory judgment action in the United States District Court for the Eastern District of North Carolina, requesting the Court to make a determination that the Company’s BUNAVAIL™ product does not infringe the RB Plaintiffs’ ‘832 Patent, US Patent No. 7,897,080 (‘080 Patent) and US Patent No. 8,652,378 (‘378 Patent). With the DJ Action, there is an automatic stay in proceedings. The RB Plaintiffs may request that the stay be lifted, but they have the burden of showing that the stay should be lifted. For the ‘832 Patent, the January 15, 2014 IPR was instituted and all challenged claims were rejected for both anticipation and obviousness. For the ‘080 Patent, all claims remain rejected in an inter partes reexamination and the reexamination is currently in the appeals process, with the oral hearing scheduled for November 5, 2014. For the ‘378 Patent, an IPR was filed on June 1, 2014. As in prior litigation proceedings, the Company believes these IPR and the reexamination filings will provide support for maintaining the stay until the IPR and reexamination proceedings conclude. | |
On September 22, 2014, the RB Plaintiffs filed an action against the Company (and its commercial partner) relating to the Company’s BUNAVAIL™ product in the United States District Court for the District of New Jersey for alleged patent infringement. The RB Plaintiffs claim that BUNAVAIL™, whose formulation and manufacturing processes have never been disclosed publicly, infringes its patent (U.S. Patent No. 8,765,167) (‘167 Patent). As with prior actions by the RB Plaintiffs, the Company believes this is another anticompetitive attempt by the RB Plaintiffs to distract the Company’s efforts from commercializing BUNAVAIL™. The Company strongly refutes as without merit the RB Plaintiffs’ assertion of patent infringement and will vigorously defend the lawsuit. In this regard, on October 28, 2014, the Company recently filed multiple IPR requests on the ’167 Patent demonstrating that certain claims of such patent were anticipated by or obvious in the light of prior art references, including prior art references not previously considered by the USPTO, and thus, invalid. |
Basis_of_presentation_Policies
Basis of presentation (Policies) | 9 Months Ended |
Sep. 30, 2014 | |
Accounting Policies [Abstract] | ' |
Overview | ' |
Overview: | |
The accompanying unaudited condensed consolidated financial statements of BioDelivery Sciences International, Inc., a Delaware corporation, together with its wholly-owned subsidiaries, Arius Pharmaceuticals, Inc., a Delaware corporation (“Arius One”), and Arius Two, Inc., a Delaware corporation (“Arius Two”), and its majority-owned, inactive subsidiary, Bioral Nutrient Delivery, LLC, a Delaware limited liability company (“BND”, together with Arius One and Arius Two, collectively, the “Company” or “we”, “us” or similar terminology) have been prepared by the Company without audit. In the opinion of management, all adjustments (which include normal recurring adjustments) necessary to present fairly the financial position, results of operations and cash flows at September 30, 2014, and for all periods presented, have been made. All intercompany accounts and transactions have been eliminated. | |
Certain information and note disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) have been condensed or omitted pursuant to the Securities and Exchange Commission (“SEC”) rules and regulations. These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2013, which are included in the Company’s 2013 Annual Report on Form 10-K, filed with the SEC on March 14, 2014 (the “2013 Annual Report”). The accompanying condensed consolidated balance sheet at December 31, 2013 has been derived from the audited financial statements at that date, but does not include all information and notes required by GAAP for complete financial statements. The Company has reclassified certain amounts within cash flows from operating activities in the Statements of Cash Flows for the nine months ended September 30, 2013 to conform to the current year presentation. This reclassification had no effect on the measurement of aggregate cash flows from operating, investing or financing activities. | |
The Company is a specialty pharmaceutical company that is leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. The Company is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction. | |
The Company’s franchise currently consists of four products or product candidates, three of which utilize the Company’s patented BioErodible MucoAdhesive (“BEMA”) drug delivery technology, a thin film applied to the inner lining of the cheek. ONSOLIS® (fentanyl buccal soluble film) is approved in the U.S., Canada, EU (where it is marketed as BREAKYL™) and Taiwan (where it is marketed as PAINKYL™), for the management of breakthrough pain in opioid tolerant, adult patients with cancer. The commercial rights to ONSOLIS® are licensed to Meda AB (“Meda”) for all territories worldwide except for Taiwan (licensed to TTY Biopharm Co. Ltd. (“TTY”)) and South Korea (licensed to Kunwha Pharmaceutical Co., Ltd. (“Kunwha”)). | |
The Company’s second product using the BEMA® technology is BUNAVAIL™ (buprenorphine and naloxone) buccal film, which was approved by the U.S. Food and Drug Administration (“FDA”) in June 2014 for the maintenance treatment of opioid dependence. The Company is commercializing BUNAVAIL™ with a launch scheduled for fourth quarter 2014. As with all other buprenorphine containing products for opioid dependence, the approval of BUNAVAIL™ carries a standard post-approval requirement by the FDA to conduct a study to determine the effect of BUNAVAIL™ on QT prolongation (i.e., an abnormal lengthening of the heartbeat). The clinical study results must be reported to the FDA by the end of 2016. | |
The Company’s third product using the BEMA® technology, BEMA® Buprenorphine, is for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate and is licensed on a worldwide basis to Endo Health Solutions, Inc. (“Endo”). Positive study results for two pivotal Phase 3 trials for this product were reported by the Company in January and July 2014. In August 2014, the Company announced that, along with Endo, it engaged in a positive pre-New Drug Application (“NDA”) meeting with the FDA regarding its BEMA® Buprenorphine product. | |
The Company’s fourth product is Clonidine Topical Gel, which is currently in Phase 3 development for the treatment of painful diabetic neuropathy (“PDN”), which was licensed from Arcion Therapeutics, Inc. (“Arcion”) in March 2013. In June 2014, the Company announced the completion of patient enrollment for the Company’s Phase 3 study of Clonidine Topical Gel. In August 2014, the Company announced that it had completed a pre-specified interim analysis of the ongoing initial pivotal Phase 3 trial for Clonidine Topical Gel. | |
The results of operations for the three and nine month periods ended September 30, 2014 are not necessarily indicative of results that may be expected for any other interim period or for the full fiscal year. Readers of this Quarterly Report are strongly encouraged to review the risk factors relating to the Company which are set forth in the 2013 Annual Report. | |
BDSI® and BEMA® are registered trademarks of the Company. The BioDelivery Sciences logo and BUNAVAIL™ are trademarks owned by the Company. ONSOLIS® is a registered trademark of Meda Pharmaceuticals, Inc. BREAKYL™ is a trademark owned by Meda Pharma GmbH & Co. KG. PAINKYL™ is a trademark owned by TTY Biopharm. All other trademarks and tradenames are owned by their respective owners. | |
As used herein, the term “Common Stock” means the Company’s common stock, par value $.001 per share. | |
Fair value of financial assets and liabilities | ' |
Fair value of financial assets and liabilities: | |
The Company measures the fair value of financial assets and liabilities in accordance with GAAP which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. | |
GAAP defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. GAAP also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. GAAP describes three levels of inputs that may be used to measure fair value: | |
Level 1 – quoted prices in active markets for identical assets or liabilities | |
Level 2 – quoted prices for similar assets and liabilities in active markets or inputs that are observable | |
Level 3 – inputs that are unobservable (for example cash flow modeling inputs based on assumptions) | |
Inventory | ' |
Inventory | |
The Company utilizes contract manufacturers in all phases of the creation of BUNAVAIL™. At September 30, 2014, inventory includes the cost of raw materials, work in process and finished goods at the Company’s contract manufacturer and third party logistics provider related to the pending launch of BUNAVAIL™. Inventory is stated at the lower of cost or market using the specific identification method, and cost is determined on a first-in, first-out basis. As of September 30, 2014, inventory is composed of $0.4 million of raw materials, $0.3 million of work in process and $1.3 million of finished goods. | |
Equipment | ' |
Equipment | |
Office and Manufacturing equipment are carried at cost less accumulated depreciation, which is computed on a straight-line basis over their estimated useful lives, generally three to ten years. | |
Due to the postponement of the U.S. re-launch of ONSOLIS® (see note 3), related manufacturing equipment, net, totaling $2.7 million has been deemed idle, and has been reclassified to idle equipment, net in the accompanying condensed consolidated balance sheets. The Company evaluates the carrying value of the idle equipment when events or changes in circumstances indicate the related carrying amount may not be recoverable. The Company has not recorded any impairment of this equipment during the nine months ended September 30, 2014. | |
Recent accounting pronouncements | ' |
Recent accounting pronouncements: | |
In May 2014, the Financial Accounting Standards Board issued Accounting Standards Update 2014-09, “Revenue from Contracts with Customers,” which supersedes the revenue recognition requirements of Accounting Standards Codification (“ASC”) Topic 605, “Revenue Recognition” and most industry-specific guidance on revenue recognition throughout the ASC. The new standard is principles-based and provides a five step model to determine when and how revenue is recognized. The core principle of the new standard is that revenue should be recognized when a company transfers promised goods or services to customers in an amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. The new standard also requires disclosure of qualitative and quantitative information surrounding the amount, nature, timing and uncertainty of revenues and cash flows arising from contracts with customers. The new standard will be effective for the Company in the first quarter of the year ending December 31, 2017 and can be applied either retrospectively to all periods presented or as a cumulative-effect adjustment as of the date of adoption. Early adoption is not permitted. The Company is currently evaluating the impact of adoption of the new standard on its consolidated financial statements. |
MidCap_Secured_Loan_Facility_T
MidCap Secured Loan Facility (Tables) | 9 Months Ended | ||||
Sep. 30, 2014 | |||||
Debt Disclosure [Abstract] | ' | ||||
Schedule Showing Allocation of Secured Loan Facility to Notes Payable and Midcap Warrants | ' | ||||
The proceeds of the secured loan facility were allocated to the note payable and Midcap warrants (which qualified for equity accounting) based on their relative fair values, as follows: | |||||
Note payable | $ | 19,013,648 | |||
MidCap warrant | 986,352 | ||||
Total proceeds | $ | 20,000,000 | |||
Schedule of Fair Value of Warrants Based Upon the Black Scholes Valuation Model Assumptions | ' | ||||
The fair value of the warrants was determined based upon the Black Scholes valuation model using the following key assumptions: | |||||
Market price of stock | $ | 4.41 | |||
Term of warrant | 5 years | ||||
Volatility | 81.05 | % | |||
Risk free interest rate | 2.9 | % | |||
Future Maturities of MidCap Obligation | ' | ||||
The following table represents future maturities of the MidCap obligation as of September 30, 2014: | |||||
Years ending September 30, | |||||
2015 | 8,000,000 | ||||
2016 | 6,666,667 | ||||
Total maturities | 14,666,667 | ||||
Unamortized discount | (575,371 | ) | |||
Total Midcap obligation | $ | 14,091,296 | |||
Derivative_Financial_Instrumen1
Derivative Financial Instruments (Tables) | 9 Months Ended | ||||||||||||||||||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||||||||||||||||||
Derivative Instruments and Hedging Activities Disclosure [Abstract] | ' | ||||||||||||||||||||||||||||||||
Summary of Assets and Liabilities Measured at Fair Value on a Recurring Basis | ' | ||||||||||||||||||||||||||||||||
The following table summarizes assets and liabilities measured at fair value on a recurring basis at September 30, 2014 and December 31, 2013, respectively: | |||||||||||||||||||||||||||||||||
September 30, 2014 | December 31, 2013 | ||||||||||||||||||||||||||||||||
Level | Level | Level | Total | Level | Level | Level | Total | ||||||||||||||||||||||||||
1 | 2 | 3 | 1 | 2 | 3 | ||||||||||||||||||||||||||||
Fair Value | |||||||||||||||||||||||||||||||||
Measurements Using: | |||||||||||||||||||||||||||||||||
Liabilities | |||||||||||||||||||||||||||||||||
Derivative liabilities- free standing warrants | $ | — | $ | 12,579,418 | $ | — | $ | 12,579,418 | $ | — | $ | 4,315,183 | $ | — | $ | 4,315,183 | |||||||||||||||||
Reconciliation of Beginning and Ending Balances of Assets and Liabilities Measured at Fair Value Using Significant Observable Inputs | ' | ||||||||||||||||||||||||||||||||
The table below provides a reconciliation of the beginning and ending balances for the liabilities measured at fair value using observable inputs (Level 2). The table reflects net gains and losses for all financial liabilities categorized as Level 2 as of September 30, 2014 and December 31, 2013. | |||||||||||||||||||||||||||||||||
$ | Number of | ||||||||||||||||||||||||||||||||
Warrants | |||||||||||||||||||||||||||||||||
Liabilities: | |||||||||||||||||||||||||||||||||
Warrant liability as of December 31, 2013 | $ | 4,315,183 | 1,999,436 | ||||||||||||||||||||||||||||||
Decrease due to exercise of warrants | (6,366,440 | ) | (1,099,011 | ) | |||||||||||||||||||||||||||||
Increase in fair value of warrants | 14,630,675 | — | |||||||||||||||||||||||||||||||
Warrant liability as of September 30, 2014 | $ | 12,579,418 | 900,425 |
Stockholders_Equity_Tables
Stockholders' Equity (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Equity [Abstract] | ' | ||||||||||||||||
Weighted Average for Key Assumptions Used in Determining Fair Value of Options Granted | ' | ||||||||||||||||
The weighted average for key assumptions used in determining the fair value of options granted during the nine months ended September 30, 2014 follows: | |||||||||||||||||
Expected price volatility | 74.7-78.05 | % | |||||||||||||||
Risk-free interest rate | 1.00-1.58 | % | |||||||||||||||
Weighted average expected life in years | 6 years | ||||||||||||||||
Dividend yield | — | ||||||||||||||||
Summary of Option Activity | ' | ||||||||||||||||
Option activity during the nine months ended September 30, 2014 was as follows: | |||||||||||||||||
Number of | Weighted | Aggregate | |||||||||||||||
Shares | Average | Intrinsic | |||||||||||||||
Exercise | Value | ||||||||||||||||
Price | |||||||||||||||||
Per Share | |||||||||||||||||
Outstanding at January 1, 2014 | 4,192,927 | $ | 3.82 | ||||||||||||||
Granted in 2014: | |||||||||||||||||
Officers and Directors | — | — | |||||||||||||||
Others | 152,265 | 9.41 | |||||||||||||||
Exercised | (1,337,878 | ) | 3.48 | ||||||||||||||
Forfeitures | — | — | |||||||||||||||
Outstanding at September 30, 2014 | 3,007,314 | $ | 4.26 | $ | 38,598,170 | ||||||||||||
Summary of Stock Options Outstanding | ' | ||||||||||||||||
Options outstanding at September 30, 2014 are as follows: | |||||||||||||||||
Range of Exercise Prices | Number | Weighted | Weighted | Aggregate | |||||||||||||
Outstanding | Average | Average | Intrinsic | ||||||||||||||
Remaining | Exercise | Value | |||||||||||||||
Contractual | Price | ||||||||||||||||
Life (Years) | |||||||||||||||||
$1.00 – 5.00 | 2,059,390 | 5.25 | $ | 3.1 | |||||||||||||
$5.01 – 10.00 | 905,344 | 4.01 | $ | 6.44 | |||||||||||||
$10.01-15.00 | 23,744 | 9.82 | $ | 12.44 | |||||||||||||
$15.01-20.00 | 18,836 | 9.99 | $ | 15.95 | |||||||||||||
3,007,314 | $ | 38,598,170 | |||||||||||||||
Summary of Stock Options Exercisable | ' | ||||||||||||||||
Options exercisable at September 30, 2014 are as follows: | |||||||||||||||||
Range of Exercise Prices | Number | Weighted | Weighted | Aggregate | |||||||||||||
Exercisable | Average | Average | Intrinsic | ||||||||||||||
Remaining | Exercise | Value | |||||||||||||||
Contractual | Price | ||||||||||||||||
Life (Years) | |||||||||||||||||
$1.00 – 5.00 | 1,725,513 | 4.69 | $ | 2.98 | |||||||||||||
$5.01 – 10.00 | 740,000 | 2.84 | $ | 6.35 | |||||||||||||
$10.01-15.00 | — | ||||||||||||||||
$15.01-20.00 | — | ||||||||||||||||
2,465,513 | $ | 32,321,327 | |||||||||||||||
Summary of Non-Vested Stock Options | ' | ||||||||||||||||
A summary of the status of the Company’s non-vested stock options as of January 1, 2014, and changes during the nine months ended September 30, 2014 is summarized as follows: | |||||||||||||||||
Nonvested Shares | Shares | Weighted | Aggregate | ||||||||||||||
Average | Intrinsic | ||||||||||||||||
Grant Date | Value | ||||||||||||||||
Fair Value | |||||||||||||||||
Nonvested at January 1, 2014 | 614,468 | ||||||||||||||||
Granted | 152,265 | ||||||||||||||||
Vested | (224,932 | ) | |||||||||||||||
Forfeited | — | ||||||||||||||||
Nonvested at September 30, 2014 | 541,801 | $ | 3.33 | $ | 6,276,843 | ||||||||||||
Summary of Warrants Outstanding to Purchase Common Stock | ' | ||||||||||||||||
Warrants outstanding at September 30, 2014, all of which are exercisable are as follows: | |||||||||||||||||
Range of Exercise Prices | Number | Weighted | Weighted | Aggregate | |||||||||||||
Outstanding | Average | Average | Intrinsic | ||||||||||||||
Remaining | Exercise | Value | |||||||||||||||
Contractual | Price | ||||||||||||||||
Life (Years) | |||||||||||||||||
$0.01 – 5.00 | 900,425 | 0.56 | $ | 3.12 | $ | 12,578,937 |
Basis_of_presentation_Addition
Basis of presentation - Additional Information (Detail) (USD $) | 9 Months Ended | |
Sep. 30, 2014 | Dec. 31, 2013 | |
Product | ||
Basis Of Presentation [Line Items] | ' | ' |
Number of products under pain franchise | 4 | ' |
Common Stock, par value | $0.00 | $0.00 |
Raw materials in inventory | $400,000 | ' |
Work in process in inventory | 300,000 | ' |
Finished goods in inventory | 1,300,000 | ' |
Office and Manufacturing equipment, basis of valuation | 'Cost | ' |
Office and Manufacturing equipment, depreciation method | 'Straight-line basis | ' |
Idle equipment, net | 2,738,898 | 2,844,718 |
Impairment Charges | 0 | ' |
Onsolis [Member] | ' | ' |
Basis Of Presentation [Line Items] | ' | ' |
Idle equipment, net | $2,700,000 | ' |
Minimum [Member] | ' | ' |
Basis Of Presentation [Line Items] | ' | ' |
Estimated useful lives of equipment | '3 years | ' |
Maximum [Member] | ' | ' |
Basis Of Presentation [Line Items] | ' | ' |
Estimated useful lives of equipment | '10 years | ' |
Liquidity_and_managements_plan1
Liquidity and management's plans - Additional Information (Detail) (USD $) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | 0 Months Ended | 9 Months Ended | 12 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2014 | Jan. 31, 2014 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Dec. 31, 2013 | Dec. 31, 2012 | Feb. 07, 2014 | Sep. 30, 2014 | Dec. 31, 2013 | Sep. 30, 2014 | Dec. 31, 2013 | |
Definitive Securities Purchase Agreement [Member] | Definitive Securities Purchase Agreement [Member] | Meda License Development and Supply Agreement [Member] | Endo License and Development Agreement [Member] | Endo License and Development Agreement [Member] | |||||||||
Liquidity and Management's Plans [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Proceeds from issuance of common stock | $8,600,000 | $3,900,000 | ' | ' | $12,500,000 | ' | ' | ' | $58,200,000 | $58,200,000 | ' | ' | ' |
Contract revenue under the Endo agreement | ' | ' | ' | ' | 22,300,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Research and development reimbursements under the Endo agreements | ' | ' | 1,297,761 | ' | 12,067,324 | ' | ' | ' | ' | ' | ' | 12,100,000 | 2,800,000 |
Exercise of Common Stock options and warrants | ' | ' | ' | ' | 4,572,919 | 347,434 | 400,000 | ' | ' | ' | ' | ' | ' |
Exercise of warrants | ' | ' | ' | ' | 4,930,796 | ' | ' | ' | ' | ' | ' | ' | ' |
Net proceeds from secured loan facility from Midcap | ' | ' | ' | ' | ' | ' | 19,800,000 | ' | ' | ' | ' | ' | ' |
Net royalties under the Meda agreements | ' | ' | 11,832 | 924,272 | 1,857,920 | 1,779,373 | ' | ' | ' | ' | 1,800,000 | ' | ' |
Contract revenue from licensing and supply agreement | ' | ' | ' | ' | ' | ' | 300,000 | ' | ' | ' | ' | ' | ' |
Cash and cash equivalents | 85,793,950 | ' | 85,793,950 | 38,296,062 | 85,793,950 | 38,296,062 | 23,175,809 | 63,189,307 | ' | ' | ' | ' | ' |
Cash from operations | ' | ' | ' | ' | ($10,798,781) | ($44,940,535) | ' | ' | ' | ' | ' | ' | ' |
Meda_License_Development_and_S1
Meda License, Development and Supply Agreements - Additional Information (Detail) (USD $) | 3 Months Ended | 9 Months Ended | 1 Months Ended | 9 Months Ended | 1 Months Ended | 9 Months Ended | 12 Months Ended | 12 Months Ended | 1 Months Ended | 0 Months Ended | |||||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Oct. 31, 2009 | Sep. 30, 2014 | Oct. 31, 2012 | Sep. 30, 2014 | Dec. 31, 2012 | Sep. 30, 2014 | Dec. 31, 2013 | Oct. 31, 2012 | 21-May-12 | |
Onsolis [Member] | Onsolis [Member] | U.S. [Member] | U.S. [Member] | EU [Member] | EU [Member] | EU [Member] | Milestones [Member] | Meda License Development and Supply Agreement [Member] | Meda License Development and Supply Agreement [Member] | Meda License Development and Supply Agreement [Member] | |||||
EU [Member] | EU [Member] | EU [Member] | |||||||||||||
Onsolis [Member] | |||||||||||||||
Revenue Recognition, Multiple-deliverable Arrangements [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Patent expiration year | ' | ' | '2020 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Aggregate milestones and services revenue recognized | $512,774 | $2,072,590 | $22,471,502 | $5,603,516 | ' | ' | $59,700,000 | ' | $17,500,000 | ' | ' | ' | ' | $2,500,000 | $2,500,000 |
Remaining deferred revenue related to the EU Media arrangement milestones | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 900,000 | ' | ' | ' |
Additional revenues in milestones | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 5,000,000 | ' | ' | ' | ' |
Product royalty revenues | 11,832 | 924,272 | 1,857,920 | 1,779,373 | 1,900,000 | 1,800,000 | ' | ' | ' | ' | ' | ' | 1,800,000 | ' | ' |
Cost of product sales | 462,802 | 643,486 | 1,875,365 | 1,708,693 | 1,900,000 | 1,700,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Estimated portion of upfront payments | ' | ' | ' | ' | ' | ' | ' | $1,100,000 | ' | $100,000 | ' | ' | ' | ' | ' |
Shelf life of the product | ' | ' | '24 months | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Period for application review | ' | ' | '6 months | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Endo_License_and_Development_A1
Endo License and Development Agreement - Additional Information (Detail) (USD $) | 9 Months Ended | 12 Months Ended | 9 Months Ended | |||||||
In Millions, unless otherwise specified | Sep. 30, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Jun. 25, 2014 | Jan. 23, 2014 | 31-May-12 | Jan. 17, 2012 | Jan. 31, 2014 | Jun. 30, 2014 | Sep. 30, 2014 |
Milestone | Clinical Trials One [Member] | Clinical Trials Two [Member] | Endo License and Development Agreement [Member] | |||||||
Related Party Transaction [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Non-refundable payment received | ' | ' | ' | ' | ' | ' | $30 | ' | ' | ' |
Potential milestone payments on intellectual property rights | 15 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Potential milestone payment received clinical development | 20 | ' | ' | ' | ' | ' | ' | 10 | 10 | ' |
Potential payment upon filing and acceptance | 10 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Potential milestone payment receivable upon regulatory approval | 50 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Payment receivable on achievement of potential sales milestones | 55 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of potential sales milestones | 4 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Recognized up-front payment allocated to the license | 15.6 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Recognized up-front payment to clinical trial material and development services | 14.4 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Upfront payment | 30 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Estimated amount recognized against clinical services deliverable | 2.3 | 6.3 | 5.2 | ' | ' | ' | ' | ' | ' | ' |
Deferred revenue income of the research and development activities | 0.6 | ' | ' | ' | ' | ' | ' | ' | ' | 12.1 |
Term of Endo Agreement | '10 years | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Extended patent on drug delivery technology | '2020 to 2027 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Potential milestone payments on issuance of patent | ' | ' | ' | ' | ' | 15 | ' | ' | ' | ' |
Milestone payment regarding licensing agreement | ' | ' | ' | 10 | 10 | ' | ' | ' | ' | ' |
Total rate of reimbursable contractor costs borne | 50.00% | ' | ' | ' | ' | ' | ' | ' | ' | 50.00% |
Reimbursement rate of costs by Endo to the company as per agreement | ' | ' | ' | ' | ' | ' | ' | ' | ' | 100.00% |
Percentage of credit against potential future milestone | ' | ' | ' | ' | ' | ' | ' | ' | ' | 50.00% |
Deferred revenue recognized during the period | $4.80 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Arcion_License_Agreement_Addit
Arcion License Agreement - Additional Information (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Patient | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ' | ' | ' | ' |
Common stock locking period | ' | ' | '9 months | ' |
Potential payments upon filing and acceptance | ' | ' | $10,000,000 | ' |
Milestone payments increased | ' | ' | 8,000,000 | ' |
Research and development expense | 6,769,698 | 16,387,194 | 29,375,895 | 41,177,577 |
Number of additional patients participating in the study | ' | ' | 80 | ' |
Power percentage goal for interim study | 90.00% | ' | 90.00% | ' |
U.S. [Member] | ' | ' | ' | ' |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ' | ' | ' | ' |
Potential Payments upon achieving certain pre-determined sales thresholds in the U.S | ' | ' | 60,000,000 | ' |
U.S. [Member] | Minimum [Member] | ' | ' | ' | ' |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ' | ' | ' | ' |
Milestone Sales | ' | ' | 200,000,000 | ' |
Milestone payment receivable from sublicenses | ' | ' | 70,000,000 | ' |
Arcion License Agreement [Member] | ' | ' | ' | ' |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ' | ' | ' | ' |
Share issued to Arcion | ' | ' | 500,516 | ' |
Fair market value of unregistered shares issued | ' | ' | 2,100,000 | ' |
Potential payments upon filing and acceptance | ' | ' | 2,500,000 | ' |
Royalty term description | ' | ' | 'The royalty term for any given country is the later of (i) the first date there are no valid claims against any Arcion patent, (ii) expiration of patent exclusivity or (iii) tenth anniversary of the first commercial sale. | ' |
Research and development expense | ' | ' | ' | 2,100,000 |
Arcion License Agreement [Member] | Minimum [Member] | ' | ' | ' | ' |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ' | ' | ' | ' |
Potential milestone payment upon FDA approval | ' | ' | 17,500,000 | ' |
Arcion License Agreement [Member] | Maximum [Member] | ' | ' | ' | ' |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ' | ' | ' | ' |
Potential milestone payment upon FDA approval | ' | ' | $35,000,000 | ' |
Other_License_Agreements_and_A1
Other License Agreements and Acquired Product Rights - Additional Information (Detail) (USD $) | 0 Months Ended | 1 Months Ended | 3 Months Ended | 9 Months Ended |
In Millions, unless otherwise specified | Oct. 07, 2010 | Nov. 30, 2011 | Sep. 30, 2013 | Sep. 30, 2014 |
Kunwha License Agreement [Member] | ' | ' | ' | ' |
Other License Agreements And Acquired Product Rights [Line Items] | ' | ' | ' | ' |
Expiration date of the agreement | ' | ' | ' | 23-Jul-27 |
Upfront payment | ' | ' | ' | 0.3 |
Up-front payment net of tax | ' | ' | ' | 0.25 |
Milestone payments | ' | ' | ' | 1.3 |
Milestone payments net of tax | ' | ' | ' | 1.1 |
TTY License and Supply Agreement [Member] | ' | ' | ' | ' |
Other License Agreements And Acquired Product Rights [Line Items] | ' | ' | ' | ' |
Upfront payment | 0.3 | ' | ' | ' |
Milestone payments | 1.3 | ' | ' | ' |
Term of the agreement | ' | ' | ' | '15 years |
Milestone payment received | ' | $0.30 | $0.30 | ' |
MidCap_Secured_Loan_Facility_A
MidCap Secured Loan Facility - Additional Information (Detail) (USD $) | 9 Months Ended | 12 Months Ended | 0 Months Ended | 9 Months Ended |
Sep. 30, 2014 | Dec. 31, 2013 | Jul. 05, 2013 | Sep. 30, 2014 | |
Mid Cap [Member] | Mid Cap [Member] | |||
Debt [Line Items] | ' | ' | ' | ' |
Secured loan facility | ' | ' | $20,000,000 | ' |
Net proceeds in aggregate amount | ' | ' | 19,800,000 | ' |
Unregistered shares of common stock | 357,356 | ' | ' | ' |
Warrant exercise price | $4.20 | ' | ' | ' |
Days of volume-weighted average share price | '20-day volume-weighted average share price of the Common Stock prior to the closing of the Loan | ' | ' | ' |
Warrant exercisable term | '5 years | ' | ' | ' |
Amortization Period of Discount | '3 years | ' | ' | ' |
Term of loan | '36 months | ' | ' | ' |
Interest rate | ' | 8.45% | ' | ' |
LIBOR floor Rate | ' | 0.50% | ' | ' |
Interest rate at period end | 8.95% | 8.95% | ' | ' |
Final payment fee Rate | 3.50% | ' | ' | ' |
Closing fee | 0.50% | ' | ' | ' |
Exit fee percentage recorded as deferred loan costs | 3.50% | ' | ' | ' |
Loan amount prepaid in the first year of the Loan | 5.00% | ' | ' | ' |
Loan amount prepaid in each year thereafter | 3.00% | ' | ' | ' |
Notice Period | ' | ' | ' | '10 days |
Rate of interest Applicable to obligations | ' | ' | ' | 4.00% |
Secured loan facility due to Midcap | ' | ' | ' | 14,091,296 |
Unamortized discount net | ' | ' | ' | $575,371 |
MidCap_Secured_Loan_Facility_S
MidCap Secured Loan Facility - Schedule Showing Allocation of Secured Loan Facility to Notes Payable and Midcap Warrants (Detail) (USD $) | 9 Months Ended | |
Sep. 30, 2014 | Sep. 30, 2013 | |
Debt [Line Items] | ' | ' |
Total proceeds | $0 | $20,000,000 |
Note payable [Member] | ' | ' |
Debt [Line Items] | ' | ' |
Total proceeds | 19,013,648 | ' |
Midcap warrant [Member] | ' | ' |
Debt [Line Items] | ' | ' |
Total proceeds | $986,352 | ' |
MidCap_Secured_Loan_Facility_S1
MidCap Secured Loan Facility - Schedule of Fair Value of Warrants Based Upon the Black Scholes Valuation Model Assumptions (Detail) (USD $) | 9 Months Ended |
Sep. 30, 2014 | |
Debt Disclosure [Abstract] | ' |
Market price of stock | $4.41 |
Term of warrant | '5 years |
Volatility | 81.05% |
Risk free interest rate | 2.90% |
MidCap_Secured_Loan_Facility_F
MidCap Secured Loan Facility - Future Maturities of MidCap Obligation (Detail) (Mid Cap [Member], USD $) | Sep. 30, 2014 |
Mid Cap [Member] | ' |
Debt [Line Items] | ' |
2015 | $8,000,000 |
2016 | 6,666,667 |
Total maturities | 14,666,667 |
Unamortized discount | -575,371 |
Total Midcap obligation | $14,091,296 |
Derivative_Financial_Instrumen2
Derivative Financial Instruments - Summary of Assets and Liabilities Measured at Fair Value on a Recurring Basis (Detail) (Fair Value, Measurements, Recurring [Member], USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Fair Value Asset Measured On Recurring Basis [Line Items] | ' | ' |
Derivative liabilities- free standing warrants | $12,579,418 | $4,315,183 |
Level 1 [Member] | ' | ' |
Fair Value Asset Measured On Recurring Basis [Line Items] | ' | ' |
Derivative liabilities- free standing warrants | 0 | ' |
Level 2 [Member] | ' | ' |
Fair Value Asset Measured On Recurring Basis [Line Items] | ' | ' |
Derivative liabilities- free standing warrants | 12,579,418 | 4,315,183 |
Level 3 [Member] | ' | ' |
Fair Value Asset Measured On Recurring Basis [Line Items] | ' | ' |
Derivative liabilities- free standing warrants | $0 | ' |
Derivative_Financial_Instrumen3
Derivative Financial Instruments - Reconciliation of Beginning and Ending Balances of Assets and Liabilities Measured at Fair Value Using Significant Observable Inputs (Detail) (Midcap warrant [Member], Level 2 [Member], USD $) | 9 Months Ended |
Sep. 30, 2014 | |
Midcap warrant [Member] | Level 2 [Member] | ' |
Fair Value Measurement Inputs Disclosure [Line Items] | ' |
Warrant liability, Beginning balance | $4,315,183 |
Decrease due to exercise of warrants | -6,366,440 |
Increase in fair value of warrants | 14,630,675 |
Warrant liability, Ending balance | $12,579,418 |
Warrant liability, Beginning balance, Number of warrants | 1,999,436 |
Decrease due to exercise of warrants, Number of warrants | -1,099,011 |
Increase in fair value of warrants, Number of warrants | ' |
Warrant liability, Ending balance, Number of warrants | 900,425 |
Stockholders_Equity_Additional
Stockholders' Equity - Additional information (Detail) (USD $) | 1 Months Ended | 9 Months Ended | 12 Months Ended | 0 Months Ended | 9 Months Ended | 1 Months Ended | 9 Months Ended | 1 Months Ended | 9 Months Ended | 12 Months Ended | ||||||||||||||||||||
Sep. 30, 2014 | Feb. 28, 2014 | Jan. 31, 2014 | Nov. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Dec. 31, 2013 | Feb. 07, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Nov. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2013 | Oct. 31, 2014 | Oct. 31, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Dec. 31, 2012 | Jul. 17, 2014 | Jul. 17, 2014 | Jul. 17, 2014 | |
Executives | Definitive Securities Purchase Agreement [Member] | Definitive Securities Purchase Agreement [Member] | Employees And Directors Stock Options [Member] | Restricted Stock Units (RSUs) [Member] | Restricted Stock Units (RSUs) [Member] | Midcap warrant [Member] | Common Stock [Member] | Common Stock [Member] | Series A Preferred Stock [Member] | Board Members [Member] | Board Members [Member] | New Board Member [Member] | As Reported [Member] | As Reported [Member] | Subsequent Event [Member] | Subsequent Event [Member] | Directors and Employees [Member] | LTIP [Member] | LTIP [Member] | LTIP [Member] | 2011 Equity Incentive Plan [Member] | 2011 Equity Incentive Plan [Member] | 2011 Equity Incentive Plan [Member] | |||||||
Members | Restricted Stock Units (RSUs) [Member] | Restricted Stock Units (RSUs) [Member] | Restricted Stock Units (RSUs) [Member] | Restricted Stock Units (RSUs) [Member] | Midcap warrant [Member] | Restricted Stock Units (RSUs) [Member] | Restricted Stock Units (RSUs) [Member] | Minimum [Member] | Maximum [Member] | |||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Company Issued, RSUs | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 995,619 | ' | ' | ' | ' | ' | ' | 110,000 | 15,000 | ' | ' | ' | ' | 152,265 | ' | ' | ' | ' | ' | ' |
Fair market value of shares granted | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $1,000,000 | ' | ' | ' | ' | ' | ' |
Term of options granted period | ' | ' | ' | ' | '10 years | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
RSU's Vested as per Performance criteria during period | ' | ' | ' | ' | '3 years | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '8 years | ' | ' | ' | ' |
Weighted average grant date fair value of options granted | ' | ' | ' | ' | $6.77 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of options granted in period with exercise price below market price | ' | ' | ' | ' | 0 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Unrecognized compensation cost related to non-vested share-based compensation awards granted | 11,300,000 | ' | ' | ' | 11,300,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Unrecognized compensation cost related to non-vested share-based compensation awards granted year | ' | ' | ' | ' | '2017 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Increase the number of shares of common stock authorized | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 2,000,000 | ' | ' |
Common stock authorized beginning balance | 75,000,000 | ' | ' | ' | 75,000,000 | ' | 75,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 6,800,000 | 8,800,000 |
Common stock underlying warrants | 50,569,027 | ' | ' | ' | 50,569,027 | ' | 38,188,893 | ' | ' | ' | ' | ' | 1,100,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | 600,000 | ' | ' | ' | ' | ' | ' | ' |
Proceeds from issuance of warrants | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 4,900,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1,900,000 | ' | ' | ' | ' | ' | ' | ' |
Common stock underlying warrants exercised cashless | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 357,356 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Net issuance of shares | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 218,367 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Company's securities for shelf registration | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 75,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Common Stock, shares issued | 50,584,518 | ' | 658,489 | ' | 50,584,518 | ' | 38,204,384 | 7,500,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 116,911 | ' | ' | ' | ' | ' | ' | ' | ' |
Proceeds from common stock | 8,600,000 | ' | 3,900,000 | ' | 12,500,000 | ' | ' | 58,200,000 | 58,200,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1,900,000 | ' | ' | ' | ' | ' | ' | ' | ' |
Universal shelf registration amount, maximum | ' | ' | ' | 15,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Common Stock, par value | $0.00 | ' | ' | ' | $0.00 | ' | $0.00 | $0.00 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Selling price of shares | $4.41 | ' | ' | ' | $4.41 | ' | ' | $8 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Offering price per share | ' | ' | ' | ' | ' | ' | ' | 3.10% | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Company employees, directors and affiliates stock option exercised | ' | ' | ' | ' | 1,337,878 | ' | ' | ' | ' | 1,300,000 | ' | ' | ' | ' | 1,331,063 | 0 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Proceeds from common stock | ' | ' | ' | ' | 4,572,919 | 347,434 | 400,000 | ' | ' | 4,600,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Series A Preferred shares | $0.00 | ' | ' | ' | $0.00 | ' | $0.00 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Preferred Stock, shares authorized | 5,000,000 | ' | ' | ' | 5,000,000 | ' | 5,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Series A Preferred stock converted | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 570,300 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Shares of Series A Preferred were outstanding | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 2,139,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Securities excluded from computation of diluted earnings per share | ' | ' | ' | ' | 6,000,000 | 9,200,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of executive officers from whom swing profits were recovered | ' | 3 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Short swing profits recovered | ' | 80,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Fair market value of shares granted | ' | ' | ' | ' | 8,800,000 | ' | ' | ' | ' | ' | 700,000 | 700,000 | ' | ' | ' | ' | ' | 1,500,000 | 200,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Options vesting remaining period | ' | ' | ' | ' | '3 years | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | '1 year | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of new board members | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 2 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Number of RSUs Vested | ' | ' | ' | ' | 224,932 | ' | ' | ' | ' | ' | 55,000 | 55,000 | ' | ' | ' | ' | ' | ' | ' | 359,446 | 359,446 | ' | ' | ' | ' | 4,447 | ' | ' | ' | ' |
Fair market value of previously granted RSUs vested | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | $3,200,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Restricted stock units ("RSUs") issued to directors and key employees | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1,078,000 | 978,000 | ' | ' | ' |
Restricted stock units reserve for future officers | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 100,000 | ' | ' | ' | ' | ' |
Stockholders_Equity_Weighted_A
Stockholders' Equity - Weighted Average for Key Assumptions Used in Determining Fair Value of Options Granted (Detail) | 9 Months Ended |
Sep. 30, 2014 | |
Weighted average expected life in years | '6 years |
Dividend yield | ' |
Minimum [Member] | ' |
Expected price volatility | 74.70% |
Risk-free interest rate | 1.00% |
Maximum [Member] | ' |
Expected price volatility | 78.05% |
Risk-free interest rate | 1.58% |
Stockholders_Equity_Summary_of
Stockholders' Equity - Summary of Option Activity (Detail) (USD $) | 9 Months Ended |
Sep. 30, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' |
Number of Shares, Outstanding at beginning of period | 4,192,927 |
Number of Shares, Granted | 152,265 |
Number of Shares, Exercised | -1,337,878 |
Number of Shares, Forfeitures | ' |
Number of Shares, Outstanding at end of period | 3,007,314 |
Weighted Average Exercise Price Per Share, Outstanding at beginning of period | $3.82 |
Weighted average Exercise Price Per Share, Exercised | $3.48 |
Weighted Average Exercise Price Per Share, Forfeitures | ' |
Weighted Average Exercise Price Per Share, Outstanding at end of period | $4.26 |
Aggregate Intrinsic Value, Outstanding at beginning of period | ' |
Aggregate Intrinsic Value, Outstanding at end of period | $38,598,170 |
Officers and Directors [Member] | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' |
Number of Shares, Granted | ' |
Weighted Average Exercise Price Per Share, Granted | ' |
Others [Member] | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' |
Number of Shares, Granted | 152,265 |
Weighted Average Exercise Price Per Share, Granted | $9.41 |
Stockholders_Equity_Summary_of1
Stockholders' Equity - Summary of Stock Options Outstanding (Detail) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2014 |
$1.00 - 5.00 [Member] | $5.01 - 10.00 [Member] | $ 10.01 - 15.00 [Member] | $15.01 - 20.00 [Member] | |||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ' | ' | ' | ' | ' | ' |
Range of Exercise Prices, minimum | ' | ' | $1 | $5.01 | $10.01 | $15.01 |
Range of Exercise Prices, maximum | ' | ' | $5 | $10 | $15 | $20 |
Number Outstanding | 3,007,314 | ' | 2,059,390 | 905,344 | 23,744 | 18,836 |
Weighted Average Remaining Contractual Life (Years) | ' | ' | '5 years 3 months | '4 years 4 days | '9 years 9 months 26 days | '9 years 11 months 27 days |
Weighted Average Exercise Price | ' | ' | $3.10 | $6.44 | $12.44 | $15.95 |
Aggregate Intrinsic Value | $38,598,170 | ' | ' | ' | ' | ' |
Stockholders_Equity_Summary_of2
Stockholders' Equity - Summary of Stock Options Exercisable (Detail) (USD $) | 9 Months Ended |
Sep. 30, 2014 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ' |
Number Exercisable | 2,465,513 |
Weighted Average Remaining Contractual Life (Years) | '0 years |
Weighted Average Exercise Price | ' |
Aggregate Intrinsic Value | $32,321,327 |
$1.00 - 5.00 [Member] | ' |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ' |
Range of Exercise Prices, minimum | $1 |
Range of Exercise Prices, maximum | $5 |
Number Exercisable | 1,725,513 |
Weighted Average Remaining Contractual Life (Years) | '4 years 8 months 9 days |
Weighted Average Exercise Price | $2.98 |
Aggregate Intrinsic Value | ' |
$5.01 - 10.00 [Member] | ' |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ' |
Range of Exercise Prices, minimum | $5.01 |
Range of Exercise Prices, maximum | $10 |
Number Exercisable | 740,000 |
Weighted Average Remaining Contractual Life (Years) | '2 years 10 months 2 days |
Weighted Average Exercise Price | $6.35 |
Aggregate Intrinsic Value | ' |
$ 10.01 - 15.00 [Member] | ' |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ' |
Range of Exercise Prices, minimum | $10.01 |
Range of Exercise Prices, maximum | $15 |
Number Exercisable | ' |
Weighted Average Remaining Contractual Life (Years) | '0 years |
Weighted Average Exercise Price | ' |
Aggregate Intrinsic Value | ' |
$15.01 - 20.00 [Member] | ' |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ' |
Range of Exercise Prices, minimum | $15.01 |
Range of Exercise Prices, maximum | $20 |
Number Exercisable | ' |
Weighted Average Remaining Contractual Life (Years) | '0 years |
Weighted Average Exercise Price | ' |
Aggregate Intrinsic Value | ' |
Stockholders_Equity_Summary_of3
Stockholders' Equity - Summary of Non-Vested Stock Options (Detail) (USD $) | 9 Months Ended |
Sep. 30, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Nonvested, Number of Shares [Roll Forward] | ' |
Nonvested at beginning of period | 614,468 |
Nonvested, Shares, Granted | 152,265 |
Nonvested, Shares, Vested | -224,932 |
Nonvested, Shares, Forfeited | ' |
Nonvested at end of period | 541,801 |
Weighted Average Grant Date Fair Value, Nonvested at September 30, 2014 | $3.33 |
Nonvested at September 30, 2014, Aggregate Intrinsic Value | $6,276,843 |
Stockholders_Equity_Summary_of4
Stockholders' Equity - Summary of Warrants Outstanding to Purchase Common Stock (Detail) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 | Sep. 30, 2014 | Sep. 30, 2014 |
$ 10.01 - 15.00 [Member] | Midcap warrant [Member] | |||
$ 10.01 - 15.00 [Member] | ||||
Warrants, by Exercise Price Range [Line Items] | ' | ' | ' | ' |
Range of Exercise Prices, minimum | ' | ' | $0.01 | ' |
Range of Exercise Prices, maximum | ' | ' | $5 | ' |
Number Outstanding | 3,007,314 | 4,192,927 | ' | 900,425 |
Weighted Average Remaining Contractual Life (Years) | ' | ' | ' | '6 months 22 days |
Weighted Average Exercise Price | $4.26 | $3.82 | ' | $3.12 |
Aggregate Intrinsic Value | $38,598,170 | ' | ' | $12,578,937 |
Commitments_and_contingencies_
Commitments and contingencies - Additional Information (Detail) | 1 Months Ended |
Mar. 31, 2012 | |
Patents | |
Commitments and Contingencies Disclosure [Abstract] | ' |
Number of Patents under infringement Lawsuit, against the entity rejected by USPTO | 3 |