Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Mar. 14, 2017 | Jun. 30, 2016 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2016 | ||
Document Fiscal Year Focus | 2,016 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | BDSI | ||
Entity Registrant Name | BIODELIVERY SCIENCES INTERNATIONAL INC | ||
Entity Central Index Key | 1,103,021 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Common Stock, Shares Outstanding | 54,796,622 | ||
Entity Public Float | $ 93,505,279 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 | |
Current assets: | |||
Cash | $ 32,019 | $ 83,560 | |
Accounts receivable, net | 3,569 | 2,488 | |
Inventory | 3,368 | 2,558 | |
Prepaid expenses and other current assets | 4,136 | 3,933 | |
Total current assets | 43,092 | 92,539 | |
Property and equipment, net | 4,230 | 4,262 | |
Goodwill | 2,715 | 2,715 | |
Other intangible assets, net | 2,285 | 3,256 | |
Total assets | 52,322 | 102,772 | |
Current liabilities: | |||
Accounts payable and accrued liabilities | 18,174 | 19,501 | |
Notes payable, current maturities, net | 6,707 | ||
Deferred revenue, current | 1,716 | 1,875 | |
Total current liabilities | 19,890 | 28,083 | |
Notes payable, less current maturities, net | [1] | 29,272 | 22,168 |
Deferred revenue, long-term | 20,000 | 20,000 | |
Other long-term liabilities | 825 | 825 | |
Total liabilities | 69,987 | 71,076 | |
Commitments and contingencies (Notes 7 and 14) | |||
Stockholders' equity: | |||
Preferred Stock, $.001 par value; 5,000,000 shares authorized; 2,093,155 shares of Series A Non-Voting Convertible Preferred Stock outstanding at both December 31, 2016 and 2015, respectively. | 2 | 2 | |
Common Stock, $.001 par value; 75,000,000 shares authorized; 54,133,511 and 52,730,799 shares issued; 54,118,020 and 52,715,308 shares outstanding at December 31, 2016 and 2015, respectively | 54 | 53 | |
Additional paid-in capital | 292,667 | 274,891 | |
Treasury stock, at cost, 15,491 shares | (47) | (47) | |
Accumulated deficit | (310,341) | (243,203) | |
Total stockholders' (deficit) equity | (17,665) | 31,696 | |
Total liabilities and stockholders' (deficit) equity | $ 52,322 | $ 102,772 | |
[1] | The 2016 amount disclosed in Notes payable, less current maturities, reflects the February 21, 2017 payoff of the MidCap Financial Trust obligation and simultaneous entrance into a term loan agreement with CRG Servicing LLC. (See notes 9 and 15). |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2016 | Dec. 31, 2015 |
Preferred Stock, par value | $ 0.001 | $ 0.001 |
Preferred Stock, shares authorized | 5,000,000 | 5,000,000 |
Common Stock, par value | $ 0.001 | $ 0.001 |
Common Stock, shares authorized | 75,000,000 | 75,000,000 |
Common Stock, shares issued | 54,133,511 | 52,730,799 |
Common Stock, shares outstanding | 54,118,020 | 52,715,308 |
Treasury stock, shares | 15,491 | 15,491 |
Series A Non-Voting Convertible Preferred Stock [Member] | ||
Preferred Stock, shares outstanding | 2,093,155 | 2,093,155 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Revenues: | |||
Product sales | $ 8,266 | $ 4,157 | $ 76 |
Product royalty revenues | 3,646 | 1,406 | 3,407 |
Research and development reimbursements | 1,134 | 909 | 12,712 |
Contract revenue | 2,500 | 41,759 | 22,749 |
Total revenues | 15,546 | 48,231 | 38,944 |
Cost of sales | 11,258 | 8,101 | 4,939 |
Expenses: | |||
Research and development | 18,878 | 20,624 | 34,285 |
Selling, general and administrative | 49,345 | 54,685 | 38,460 |
Total expenses | 68,223 | 75,309 | 72,745 |
Loss from operations | (63,935) | (35,179) | (38,740) |
Interest expense, net | (3,267) | (2,518) | (2,016) |
Derivative loss | (13,167) | ||
Other income (expense), net | 64 | 25 | (295) |
Net loss | $ (67,138) | $ (37,672) | $ (54,218) |
Basic and diluted loss per share | $ (1.25) | $ (0.72) | $ (1.12) |
Weighted average common stock shares outstanding, basic and diluted | 53,679,134 | 52,384,876 | 48,355,200 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' (Deficit) Equity - USD ($) $ in Thousands | 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) | $ 39 | $ 150,506 | $ (47) | $ (151,313) | $ 3 |
Beginning Balance, shares at Dec. 31, 2013 | 38,204,384 | 2,709,300 | ||||
Stock-based compensation | 6,883 | 6,883 | ||||
Stock option exercise | $ 4,580 | $ 1 | 4,579 | |||
Stock option exercise, shares | 1,332,563 | 1,332,563 | ||||
Restricted stock awards, shares | 473,893 | |||||
Warrant derivative liability reclassified to equity | $ 17,478 | 17,478 | ||||
Warrant exercises | 7,741 | $ 2 | 7,739 | |||
Warrant exercises, shares | 1,999,153 | |||||
Cashless exercise of warrants | 0 | $ 0 | 0 | 0 | 0 | $ 0 |
Cashless exercise of warrants, shares | 218,367 | |||||
Shares issued pursuant to registered direct offering, net | 58,182 | $ 8 | 58,174 | |||
Shares issued pursuant to registered direct offering, net shares | 7,500,000 | |||||
Shares issued pursuant to an at the market offering, net | 14,480 | $ 1 | 14,479 | |||
Shares issued pursuant to an at the market offering, net, shares | 1,304,410 | |||||
Short swing profit return / Issuance of warrants | 82 | 82 | ||||
Conversion of preferred shares to common shares | $ 1 | $ (1) | ||||
Conversion of preferred shares to common shares, shares | 570,300 | (570,300) | ||||
Net loss | (54,218) | (54,218) | ||||
Ending Balance at Dec. 31, 2014 | 54,396 | $ 52 | 259,920 | (47) | (205,531) | $ 2 |
Ending Balance, shares at Dec. 31, 2014 | 51,603,070 | 2,139,000 | ||||
Stock-based compensation | 14,249 | 14,249 | ||||
Stock option exercise | $ 755 | 755 | ||||
Stock option exercise, shares | 235,480 | 223,923 | ||||
Restricted stock awards | $ 1 | $ 1 | ||||
Restricted stock awards, shares | 857,677 | |||||
Warrant exercises | 1 | 1 | ||||
Warrant exercises, shares | 284 | |||||
Short swing profit return / Issuance of warrants | 6 | 6 | ||||
Conversion of preferred shares to common shares, shares | 45,845 | (45,845) | ||||
Equity financing costs | (40) | (40) | ||||
Net loss | (37,672) | (37,672) | ||||
Ending Balance at Dec. 31, 2015 | 31,696 | $ 53 | 274,891 | (47) | (243,203) | $ 2 |
Ending Balance, shares at Dec. 31, 2015 | 52,730,799 | 2,093,155 | ||||
Stock-based compensation | 14,931 | 14,931 | ||||
Stock option exercise | $ 297 | 297 | ||||
Stock option exercise, shares | 147,425 | 147,426 | ||||
Restricted stock awards, shares | 592,065 | |||||
Common stock issuance upon retirement | $ 2,460 | $ 1 | 2,459 | |||
Common stock issuance upon retirement, shares | 663,221 | |||||
Short swing profit return / Issuance of warrants | 49 | 49 | ||||
Equity financing costs | 40 | 40 | ||||
Net loss | (67,138) | (67,138) | ||||
Ending Balance at Dec. 31, 2016 | $ (17,665) | $ 54 | $ 292,667 | $ (47) | $ (310,341) | $ 2 |
Ending Balance, shares at Dec. 31, 2016 | 54,133,511 | 2,093,155 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Operating activities: | |||
Net loss | $ (67,138) | $ (37,672) | $ (54,218) |
Adjustments to reconcile net loss to net cash flows from operating activities | |||
Depreciation | 437 | 329 | 123 |
Accretion of debt discount and loan costs | 397 | 500 | 642 |
Amortization of intangible assets | 971 | 970 | 972 |
Derivative loss | 13,167 | ||
Impairment loss on assets | 295 | ||
Stock-based compensation expense | 14,931 | 14,249 | 6,883 |
Changes in assets and liabilities: | |||
Accounts receivable | (1,081) | 653 | (347) |
Inventories | (810) | (730) | (1,828) |
Prepaid expenses and other assets | (203) | (1,365) | (2,252) |
Accounts payable and accrued expenses | (1,327) | 5,072 | 4,325 |
Deferred revenue | (159) | 14,262 | 3,405 |
Net cash flows from operating activities | (53,982) | (3,732) | (28,833) |
Investing activities: | |||
Purchase of equipment | (405) | (701) | (1,603) |
Net cash flows from investing activities | (405) | (701) | (1,603) |
Financing activities: | |||
Proceeds from sales of securities, net of costs incurred | 40 | (40) | 72,662 |
Proceeds from exercise of stock options | 297 | 755 | 4,580 |
Issuance of common stock | 2,460 | ||
Issuance of warrants | 49 | ||
Proceeds from exercise of common stock warrants | 1 | 7,741 | |
Payment on note payable | (3,335) | (7,333) | |
Proceeds from notes payable | 20,667 | ||
Return of short swing profits | 6 | 82 | |
Payment of deferred financing fees | (533) | ||
Net cash flows from financing activities | 2,846 | 17,521 | 77,732 |
Net change in cash and cash equivalents | (51,541) | 13,088 | 47,296 |
Cash and cash equivalents at beginning of year | 83,560 | 70,472 | 23,176 |
Cash and cash equivalents at end of year | 32,019 | 83,560 | 70,472 |
Cash paid for interest | $ 2,870 | $ 1,885 | $ 1,386 |
Nature of Business and Summary
Nature of Business and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Nature of Business and Summary of Significant Accounting Policies | 1. Nature of business and summary of significant accounting policies: Organization BioDelivery Sciences International, Inc. and subsidiaries (the “Company”) was incorporated in the State of Indiana on January 6, 1997 and reincorporated as a Delaware corporation in 2002. The Company’s subsidiaries are Arius Pharmaceuticals, Inc., a Delaware corporation (“Arius One”) and Arius Two, Inc., a Delaware corporation (“Arius Two”), each of which are wholly-owned, and its majority-owned subsidiary, Bioral Nutrient Delivery, LLC, a Delaware limited liability company (“BND”). The Company is a specialty pharmaceutical company that is leveraging its novel, proprietary and patented drug delivery technologies, including the BioErodible MucoAdhesive (“BEMA ® As used herein, the Company’s common stock, par value $.001 per share, is referred to as the “Common Stock”. Principles of consolidation The consolidated financial statements include the accounts of the Company, Arius One, Arius Two and BND. For each period presented BND has been an inactive subsidiary. All significant inter-company balances and transactions have been eliminated. Significant accounting policies: Use of estimates in financial statements The preparation of the accompanying consolidated financial statements requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates and assumptions. Reclassification Certain amounts within cash flows from operating activities in the Statements of Cash Flows for the year ended December 31, 2014 were reclassified to conform to the current year presentation. In addition, amounts were reclassified between Machinery & Equipment and Idle Equipment in note 4, for the year ended December 31, 2016. The Company also made certain reclassifications in this report’s footnote narratives and tables for the year ending December 31, 2015 to conform to the year ending December 31, 2016 presentation. These reclassifications had no effect on the previously reported net cash flows from operations, activities or net losses. Certain Risks, Concentrations and Uncertainties The Company relies on certain materials used in its development and third-party manufacturing processes, most of which are procured from two contract manufacturers and two active pharmaceutical ingredient (“API”) suppliers for BUNAVAIL ® ® In addition, the Company utilizes only one contract manufacturer to create the BUNAVAIL ® ® Key components used in the manufacture of ONSOLIS ® The Company sells its BUNAVAIL ® December 31, Customer 2016 2015 Customer A 36 % 40 % Customer B 28 % 33 % Customer C 28 % 16 % Total 92 % 89 % These three customers accounted for 91%, 90% and 88% of total annual sales during the years ended December 31, 2016, 2015 and 2014 respectively. Cash The Company places cash on deposit with financial institutions in the United States. The Federal Deposit Insurance Corporation covers $0.25 million for substantially all depository accounts. The Company may from time to time have amounts on deposit in excess of the insured limits. As of December 31, 2016, the Company had approximately $32.0 million, which exceeded these insured limits. As of December 31, 2015, the Company had approximately $83.6 million, which exceeded these insured limits. Accounts Receivable The Company typically requires its customers to remit payments within the first 30 to 37 days, depending on the customer and the products purchased. In addition, the Company offers wholesale distributors a prompt payment discount if they make payments within these deadlines. This discount is generally 2%, but may be higher in some instances due to product launches or customer and/or industry expectations. Because the Company’s wholesale distributors typically take the prompt payment discount, the Company accrues 100% of the prompt payment discounts, based on the gross amount of each invoice, at the time of sale, and the Company applies earned discounts at the time of payment. The allowance for prompt payment discounts was $0.05 million for both of December 31, 2016 and 2015, respectively. The Company performs ongoing credit evaluations and does not require collateral. As appropriate, the Company establishes provisions for potential credit losses. Allowance for doubtful accounts was $0 and $0.02 million as of December 31, 2016 and 2015, respectively. The Company writes off accounts receivable when management determines they are uncollectible and credits payments subsequently received on such receivables to bad debt expense in the period received. Write-offs during the years ending December 31, 2016, 2015 and 2014 were $0.02 million, $0 and $0, respectively. Inventory Inventories are stated at the lower of cost or market value with costs determined for each batch under the first-in, first-out On a quarterly basis, the Company analyzes its inventory levels and records allowances for inventory that has become obsolete, inventory that has a cost basis in excess of the expected net realizable value and inventory that is in excess of expected demand based upon projected product sales. There were no allowances recorded at December 31, 2016 or 2015. Inventory is composed of the following at December 31: 2016 2015 Raw Materials & Supplies $ 978 $ 443 Work-in-process 1,660 1,216 Finished Goods 730 899 Total Inventories $ 3,368 $ 2,558 Property and Equipment The Company records property and equipment at cost less accumulated depreciation, which is computed on a straight-line basis over its estimated useful lives, generally 3 to ten years. Due to the postponement of the U.S. relaunch of ONSOLIS ® ® re-tooled, ® Intangibles and Goodwill The Company reviews intangible assets with finite lives (“other intangible assets”) for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company uses an estimate of the undiscounted cash flows over the remaining life of its other intangible assets, or related group of assets where applicable, in measuring whether the assets to be held and used will be realizable. In the event of impairment, the Company would discount the future cash flows using its then estimated incremental borrowing rate to estimate the amount of the impairment. There were no impairment charges recognized on finite lived intangibles in 2016, 2015 or 2014. Intangible assets with finite useful lives are amortized over the estimated useful lives as follows: Estimated Useful Lives Licenses 15 years U.S. Product rights 8-12 years EU Product rights 7-11 Goodwill is evaluated for impairment at least annually or more frequently if events or changes in circumstances indicate that the carrying amount may not be recoverable. In the course of the evaluation of the potential impairment of goodwill, either a qualitative or a quantitative assessment may be performed. If a qualitative evaluation determines that it is more likely that not that no impairment exists, then no further analysis is performed. If a qualitative evaluation is unable to determine whether it is more likely than not that impairment has occurred, a quantitative evaluation is performed. The quantitative impairment analysis involves a two-step Deferred revenue Consistent with the Company’s revenue recognition policy, deferred revenue represents cash received in advance for licensing fees, consulting, research and development services and related supply agreements. Such payments are reflected as deferred revenue until recognized under the Company’s revenue recognition policy. Deferred revenue is classified as current if management believes the Company will be able to recognize the deferred amount as revenue within twelve months of the balance sheet date. The Company is also deferring its sales of BUNAVAIL ® Revenue recognition Net Product Sales Product Sales- As of December 31, 2016 and 2015, the Company had $1.7 million and $1.9 million of deferred revenue related to sales to wholesalers for which future returns could not be reasonably estimated at the time of sale. Deferred revenue is recognized when the product is sold to the end user, based upon prescriptions filled. To estimate product sold to end users, the Company relies on third-party information, including prescription data and information obtained from significant distributors with respect to their inventory levels and sales to customers. Deferred revenue is recorded net of estimated allowances for rebates, price adjustments, chargebacks, prompt payment and other discounts. Estimated allowances are recorded and classified as accrued expenses in the accompanying balance sheets as of December 31, 2016 and 2015 (see note 3). Product Returns- 18-month ® Rebates- Price Adjustments and Chargebacks- The Company, from time to time, offers certain promotional product-related incentives to its customers. These programs include certain product incentives to pharmacy customers and other sales stocking allowances. The Company has voucher programs for BUNAVAIL ® point-of-sale Prompt Payment Discounts- Gross to Net Accruals- License and Development agreements The Company periodically enters into license and development agreements to develop and commercialize its products. The arrangements typically are multi-deliverable arrangements that are funded through upfront payments, milestone payments and other forms of payment. The Company currently has multiple license and development agreements that are described in notes 6, 7 and 8. Depending on the nature of the contract these revenues are classified as research and development reimbursements or contract revenue. Deferred Cost of Sales The Company defers its cost of sales in connection with BUNAVAIL ® Cost of Sales The cost of sales includes the direct costs attributable to the production of ONSOLIS ® For BUNAVAIL ® ® Research and Development Expenses Research and development expenses consist of product development expenses incurred in identifying, developing and testing product candidates. Product development expenses consist primarily of labor, benefits and related employee expenses for personnel directly involved in product development activities; fees paid to professional service providers for monitoring and analyzing clinical trials; expenses incurred under joint development agreements; regulatory costs; costs of contract research and manufacturing of inventory used in testing and clinical trials; and the cost of facilities used by the Company’s product development personnel. Product development expenses are expensed as incurred and reflect costs directly attributable to product candidates in development during the applicable period and to product candidates for which the Company has discontinued development. Additionally, product development expenses include the cost of qualifying new current Good Manufacturing Practice (“cGMP”) third-party manufacturers for the Company’s product candidates, including expenses associated with any related technology transfer. All indirect costs (such as salaries, benefits or other costs related to the Company’s accounting, legal, human resources, purchasing, information technology and other general corporate functions) associated with individual product candidates are included in general and administrative expenses. Advertising Advertising costs, which include promotional expenses and the cost of placebo samples, are expensed as incurred. Advertising expenses were $4.2 million, $4.9 million and $4.8 million for the years ended December 31, 2016, 2015 and 2014, respectively, and are included in selling, general and administrative expenses in the accompanying consolidated statements of operations. Shipping and Handling Costs Shipping and handling costs are included in selling, general and administrative expenses and totaled $0.01 million, $0.01 million and $0.08 million for the years ended December 31, 2016, 2015 and 2014, respectively. Stock-based compensation The Company uses the fair-value based method to determine compensation for all arrangements under which employees and others receive shares of stock or equity instruments (warrants and options). The fair value of each option and warrant is estimated on the date of grant using the Black-Scholes valuation model that uses assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate. Expected volatility is based on historical volatility of the Company’s 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 the contract term. The risk-free rate is based on the U.S. Treasury yield. In applying the Black-Scholes options-pricing model, assumptions are as follows: 2016 2015 2014 Expected price volatility 62.65%-80.78% 73.00%-76.78% 73.00%-78.05% Risk-free interest rate 0.56%-1.70% 1.25%-1.68% 1.58%-1.70% Weighted average expected life in years 6 years 6 years 6 years Dividend yield — — — The Company estimated fair values of derivative financial instruments using the Black-Scholes option valuation technique because it embodied all of the requisite assumptions (including trading volatility, estimated terms and risk free rates) necessary to fairly value these instruments. In addition, option-based techniques were highly volatile and sensitive to changes in the Company’s trading market price which was high-historical volatility. Since derivative financial instruments were initially and subsequently carried at fair values, the Company’s operating results reflected the volatility in these estimates and assumption changes. Fair Value of Financial Instruments with Derivatives The Company measures the fair value of instruments with derivatives in accordance with generally accepted accounting principles of the United States (“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) The Company generally does not use derivative instruments to hedge exposures to cash-flow risks or market-risks that may affect the fair value of its financial instruments. Recent accounting pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2014-09, 2016-10, 2016-10 In August 2014, the FASB issued ASU No. 2014-15, 205-40): 2014-15”). 2014-15 The FASB’s new leases standard, ASU 2016-02 2016-02 year-end year-end In March 2016, the FASB issued ASU 2016-09, Improvements 2016-09 2016-09 is In January 2017, the FASB issued ASU 2017-01, Business In January 2017, the FASB issued ASU Update No. 2017-04, Intangibles—Goodwill in-process |
Liquidity
Liquidity | 12 Months Ended |
Dec. 31, 2016 | |
Text Block [Abstract] | |
Liquidity | 2. Liquidity: At December 31, 2016, the Company had cash of approximately $32 million. The Company used $51.5 million of cash during the twelve months ended December 31, 2016 and had stockholders’ deficit of $17.7 million, versus stockholders’ equity of $31.7 million at December 31, 2015. The Company expects that it has sufficient cash to manage the business as currently planned into the second half of 2018, which includes an entrance into a term loan agreement and payoff of existing credit agreement (see note 15). This estimation assumes that the Company does not accelerate the development of existing, or acquire other drug development opportunities or otherwise face unexpected events, costs or contingencies, any of which could affect the Company’s cash requirements. Additional capital will be required to support the commercialization of the Company’s reacquired BELBUCA ® ® ® |
Accounts Payable and Accrued Li
Accounts Payable and Accrued Liabilities | 12 Months Ended |
Dec. 31, 2016 | |
Payables and Accruals [Abstract] | |
Accounts Payable and Accrued Liabilities | 3. Accounts payable and accrued liabilities: The following table represents the components of accounts payable and accrued liabilities as of December 31: 2016 2015 Accounts payable $ 9,397 $ 10,177 Accrued price adjustments 592 2,207 Accrued rebates 3,842 2,581 Accrued chargebacks 10 65 Accrued compensation and benefits 2,052 1,917 Accrued royalties 518 431 Accrued clinical trial costs 615 584 Accrued legal 490 — Accrued manufacturing costs 200 183 Accrued sales and marketing costs 193 880 Accrued other 265 476 Total accounts payable and accrued expenses $ 18,174 $ 19,501 As of December 31, 2016, there were two vendors that comprised 28% of the accounts payable balance. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2016 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 4. Property and Equipment: Property and equipment, summarized by major category, consist of the following as of December 31: 2016 2015 Machinery & Equipment $ 4,476 $ 580 Computer Equipment & Software 464 460 Office furniture & Equipment 202 200 Leasehold Improvements 53 53 Idle Equipment 1,486 4,983 Total 6,681 6,276 Less Accumulated Depreciation (2,451 ) (2,014 ) Total property, plant & equipment, net $ 4,230 $ 4,262 Depreciation expense for years ended December 31, 2016, 2015 and 2014 was approximately $0.4 million, $0.3 million and $0.1 million, respectively. |
Other Intangible Assets
Other Intangible Assets | 12 Months Ended |
Dec. 31, 2016 | |
Text Block [Abstract] | |
Other Intangible Assets | 5. Other Intangible Assets: Other intangible assets, net, consisting of product rights and licenses are summarized as follows: December 31, 2016 Gross Carrying Value Accumulated Amortization Intangible Assets, net Weighted average Useful Life Product Rights $ 9,050 $ (7,052 ) $ 1,998 9.11 Licenses 1,900 (1,613 ) 287 1.84 Total Intangible Assets $ 10,950 $ (8,665 ) $ 2,285 10.95 December 31, 2015 Gross Carrying Value Accumulated Amortization Intangible Assets, net Weighted average Useful Life Product Rights $ 9,050 $ (6,177 ) $ 2,873 9.13 Licenses 1,900 (1,517 ) 383 1.72 Total Intangible Assets $ 10,950 $ (7,694 ) $ 3,256 10.85 The Company incurred amortization expense on other intangible assets of approximately $1.0 million for each of the years ended December 31, 2016, 2015 and 2014, respectively. Estimated aggregate future amortization expenses for other intangible assets for each of the next five years and thereafter are as follows: Years ending December 31, 2017 $ 925 2018 657 2019 657 2020 46 $ 2,285 |
License and Development Agreeme
License and Development Agreements | 12 Months Ended |
Dec. 31, 2016 | |
Business Combinations [Abstract] | |
License and Development Agreements | 6. License and Development Agreements: The Company periodically enters into license and development agreements to develop and commercialize its products. The arrangements typically are multi-deliverable arrangements that are funded through upfront payments, milestone payments, royalties and other forms of payment to the Company. The Company’s most significant license and development agreements are as follows: Meda License, Development and Supply Agreements In August 2006 and September 2007, the Company entered into certain agreements with Meda AB (“Meda”), a Swedish company to develop and commercialize the Company’s ONSOLIS ® ® The Company determined that, upon inception of both the U.S. and EU Meda arrangements, all deliverables were considered one combined unit of accounting. As such, all cash payments from Meda that were related to these deliverables were initially 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 delivered 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 in fiscal year 2009. 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, we announced the postponement of the U.S. relaunch of ONSOLIS ® ® Efforts to extend the Company’s supply agreement with its ONSOLIS ® On January 27, 2015, the Company announced that it had entered into an assignment and revenue sharing agreement with Meda to return to the Company the marketing authorization for ONSOLIS ® ® On May 11, 2016, the Company and Collegium Pharmaceutical, Inc. (“Collegium”) executed a definitive License and Development Agreement (the “License Agreement”) under which the Company has granted to Collegium the exclusive rights to develop and commercialize ONSOLIS ® Collegium License and Development Agreement On May 11, 2016, the Company and Collegium executed a License Agreement under which the Company granted Collegium the exclusive rights to develop and commercialize ONSOLIS ® Under the terms of the License Agreement, Collegium will be responsible for the manufacturing, distribution, marketing and sales of ONSOLIS ® ® ® ® Financial terms of the License Agreement include: • a $2.5 million upfront non-refundable • reimbursement to the Company for a pre-determined ® • $4 million payable to the Company upon first commercial sale of ONSOLIS ® • $3 million payable to the Company related to ONSOLIS ® • up to $17 million in potential payments to the Company based on achievement of certain performance and sales milestones; and • upper-teen percent royalties payable by Collegium to the Company based on various annual U.S. net sales thresholds, subject to customary adjustments and the royalty sharing arrangements described below. The License Agreement also contains customary termination provisions that include a right by either party to terminate upon the other party’s uncured material breach, insolvency or bankruptcy, as well as in the event a certain commercial milestone is not met. ONSOLIS ® ® ® ® ® Endo License and Development Agreement In January 2012, the Company entered into a License and Development Agreement with Endo Pharmaceuticals, Inc. (“Endo”) pursuant to which the Company granted Endo an exclusive commercial world-wide license to develop, manufacture, market and sell the Company’s BELBUCA ® ® around-the-clock, Pursuant to the Endo Agreement, Endo had obtained all rights necessary to complete the clinical and commercial development of BELBUCA ® ® ® ® ® Pursuant to the Endo Agreement, the Company has received the following payments: • $30 million non-refundable • $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 (earned in February 2015); • $50 million upon regulatory approval, earned in October 2015 and received in November 2015. Of the $50 million received in November 2015, $20 million related to a patent extension and was recorded as deferred revenue because all or a portion of such $20 million was contingently refundable to Endo if a third party generic product was introduced in the U.S. during the patent extension period from 2020 to 2027. However, due to the Company and Endo entering into a Termination Agreement on December 7, 2016 which terminated the BELBUCA ® 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 was a multi-deliverable arrangement with three deliverables: (1) the license rights related to BELBUCA ® The initial non-refundable ® Based on this analysis, $15.6 million of the up-front up-front The Company was reimbursed by Endo for certain of the research and development costs when these costs went beyond set thresholds as outlined in the Endo Agreement. Endo reimbursed the Company for this spending at cost and the Company received no mark-up 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. Endo had continued to reimburse the Company for 100% of such costs, and 50% thereof was to be taken by Endo as a credit against potential future milestones associated with achievement of certain regulatory events. As of December 31, 2014, the Company had recorded approximately $6.0 million of such cumulative payment in deferred revenue current in the accompanying consolidated balance sheet. This credit amount was deducted from the $50 million regulatory approval milestone earned by the Company in October 2015. During the years ended December 31, 2015 and 2014, the Company recognized $0.9 million and $12.7 million, respectively, of reimbursable expenses related to the Endo Agreement, which is recorded as research and development reimbursement revenue on the accompanying consolidated statement of operations. There was no research and development reimbursement revenue during the year ended December 31, 2016. On December 23, 2014, the Company and Endo announced the submission of a NDA for BELBUCA ® ® ® pre-payments On February 22, 2016, the Company and Endo announced the commercial availability of BELBUCA ® ® |
License Obligations
License Obligations | 12 Months Ended |
Dec. 31, 2016 | |
Text Block [Abstract] | |
License Obligations | 7. License Obligations: Arcion License Agreement On March 26, 2013, the Company entered into a license agreement with Arcion Therapeutics, Inc. (the “Arcion Agreement”) pursuant to which Arcion granted 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 Pursuant to the Arcion Agreement, the Company was 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. On March 30, 2015, the Company announced that the primary efficacy endpoint in its initial Phase 3 clinical study of Clonidine Topical Gel compared to placebo for the treatment of PDN did not meet statistical significance, although certain secondary endpoints showed statistically significant improvement over placebo. Final analysis of the study identified a sizeable patient population with a statistically significant improvement in pain score vs placebo. Following thorough analysis of the data and identification of the reasons behind the study results, the Company initiated a second study. The study incorporated significant learnings from previously conducted studies and involved tightened and additional inclusion criteria to improve assay sensitivity, reduce bias and ensure compliance with enrollment criteria. On December 13, 2016, the Company announced that its Phase 2b clinical study assessing the efficacy and safety of Clonidine Topical Gel failed to show a statistically significant difference in pain relief between Clonidine Topical Gel and placebo. As a result, the Company has discontinued further development of the product as of the year ended December 31, 2016. Evonik definitive Development and Exclusive License Option Agreement: On October 27, 2014, the Company entered into a definitive Development and Exclusive License Option Agreement (the “Development Agreement”) with Evonik Corporation, (“Evonik”) to develop and commercialize an injectable, extended release, microparticle formulation of buprenorphine for the treatment of opioid dependence (the “Evonik Product”). Under the Development Agreement, the Company also has the right to pursue development of the Evonik Product for pain management. Under the Development Agreement, Evonik has also granted to the Company two exclusive options to acquire exclusive worldwide licenses, with rights of sublicense, to certain patents and other intellectual property rights of Evonik to develop and commercialize certain products containing buprenorphine. If these options are exercised, such licenses would be memorialized in the Evonik License Agreement (as defined below). Pursuant to the Development Agreement, Evonik is responsible for using commercially reasonable efforts to develop a formulation for the Evonik Product in accordance with a work plan mutually agreed upon by the parties (the “Evonik Project”). Should the Evonik Project proceed past the formulation stage, Evonik also has the right to manufacture clinical and commercial supplies of Evonik Product, such manufacturing arrangement to be negotiated by the parties in good faith in a formal License and Supply Agreement(s) (the “Evonik License Agreement”), with such Evonik License Agreement covering Evonik’s intellectual property rights to be entered into between the parties if certain conditions are met and terms are mutually agreed upon. Should Evonik and the Company enter into the License Agreement following the attainment of a Phase 1 ready formulation of the Evonik Product for one or both of the opioid dependence or pain management indications, the Company would pay Evonik a non-refundable, non-creditable one-time The Development Agreement contains customary termination provisions, and the Company may additionally terminate the Development Agreement at any time after the completion of certain enumerated tasks as provided in the Development Agreement, for any reason or no reason, by providing written notice of termination to Evonik. Upon termination of the Development Agreement, Evonik will be paid any amounts owed to Evonik in accordance with the estimated budget for work performed under the Development Agreement through the effective date of termination, including any reasonable, documented, non-cancelable This product candidate is currently in the pre-clinical |
Other License Agreements and Ac
Other License Agreements and Acquired Product Rights | 12 Months Ended |
Dec. 31, 2016 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Other License Agreements and Acquired Product Rights | 8. 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 ® ® ® Under the terms of the Kunwha License Agreement, Kunwha was granted exclusive licensing rights for BEMA ® TTY License and Supply Agreement On October 7, 2010, the Company announced a license and supply agreement with TTY Biopharm Co., Ltd. (“TTY”) for the exclusive rights to develop and commercialize BEMA ® ® On July 29, 2013, the Company announced the regulatory approval of BEMA ® ™ On February 4, 2016 and June 30, 2016, the Company received separate payments of $0.2 million each from TTY and on October 4, 2016 a payment of $0.4 million, all which related to royalties based on PAINKYL ™ TTY of PAINKYL ™ |
Note Payable
Note Payable | 12 Months Ended |
Dec. 31, 2016 | |
Debt Disclosure [Abstract] | |
Note Payable | 9. Note Payable: On May 29, 2015, the Company entered into a $30 million secured loan facility (the “Loan”) with MidCap Financial Trust, as agent and lender (“MidCap”), pursuant to the terms and conditions of that certain Amended and Restated Credit and Security Agreement, dated as of May 29, 2015 (the “Credit Agreement”), between the Company and MidCap. The Credit Agreement was a restatement, amendment and modification of a prior Credit and Security Agreement, dated as of July 5, 2013 (the “Prior Agreement”) between the Company, MidCap Financial SBIC, LLP, a predecessor to MidCap, and certain lenders thereto. The Credit Agreement restructures, renews, extends and modifies the obligations under the Prior Agreement and the other financing documents executed in connection with the Prior Agreement (the “Prior Loan”). The Company received net Loan proceeds in the aggregate amount of approximately $20.1 million and will use the Loan proceeds for general corporate purposes or other activities of the Company permitted under the Credit Agreement. The original Loan had a term of 42 months, with interest only payments for the first 12 months. The interest rate is 8.45% plus a LIBOR floor of 0.5% (total of 8.95% at December 31, 2016), with straight line amortization of principal payments commencing on June 1, 2016 (now amended to January 1, 2017 per below), in an amount equal to $1 million per month. Upon execution of the Credit Agreement, the Company paid to MidCap a closing fee from the prior loan of approximately $0.4 million. Upon repayment in full of the Loan, the Company is obligated to make a final payment fee equal to 2.75% of the aggregate Loan amount. The 2.75% exit fee has been recorded as deferred loan costs, the current portion of which is included in notes payable, current maturities, net and the long-term portion is in note payable, less current maturities, net, being amortized over the life of the loan. The amounts payable are recorded as other long-term liabilities. 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 following the execution of the Credit Agreement and (ii) 3% of the Loan amount prepaid in each year thereafter. The obligations of the Company under the Credit Agreement are secured by a first priority lien in favor of MidCap on substantially all of the Company’s existing and after-acquired assets, but excluding certain intellectual property and general intangible assets of the Company (but not any proceeds thereof). The obligations of the Company under the Credit Agreement are also secured by a first priority lien on the equity interests held by the Company. The Company entered into and reaffirmed, as applicable, customary pledge and intellectual property security agreements to evidence the security interest in favor of MidCap. The debt discount is related to warrants on the Prior Loan, which was amended in 2015. The discount is being amortized to interest expense over the life of the amended loan. On May 5, 2016, the Company entered into an amendment to the Credit Agreement between the Company, MidCap and the lenders thereto (the “Lenders”) extending the interest only period of the Loan through the end of 2016. Beginning on January 1, 2017, the principal amount owed under the Loan will then be amortized over the remaining 23 months of the Loan. In association with the extension of the interest only period, the Lenders were issued warrants to purchase a total of 84,986 shares of Common Stock at an exercise price of $3.53 per share which are outstanding at December 31, 2016. As of December 31, 2016, the MidCap obligation was $29.3 million. However, on February 21, 2017, the Company entered into a term loan agreement with CRG Servicing LLC (“CRG”), as administrative agent and collateral agent, and the lenders named in the Loan Agreement (the “Lenders”).The Company utilized approximately $29.4 million of the initial loan proceeds to repay all of the amounts owed by the Company under the Credit Agreement with MidCap. Amounts due to MidCap as of the closing date included the December 31, 2016 obligation, prepayment fee, exit fee, legal fees, accrued interest and deductions for principal amounts paid in 2017. Upon the repayment of all amounts owed by the Company under the Credit Agreement, all commitments under the Credit Agreement have been terminated and all security interests granted by the Company and the Subsidiary Guarantors to the lenders under the Prior Agreement have been released (see note 15). The following table represents future maturities of the CRG obligation as of February 21, 2017: 2017 $ — 2018 — 2019 — 2020 15,000 2021 15,000 2022 15,000 Total maturities $ 45,000 Unamortized discount and loan costs (6,020 ) Total CRG obligation $ 38,980 |
Derivative Financial Instrument
Derivative Financial Instruments | 12 Months Ended |
Dec. 31, 2016 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Derivative Financial Instruments | 10. Derivative Financial Instruments: The following tabular presentation reflects the components of derivative financial instruments as of December 31: 2016 2015 2014 Derivative loss in the accompanying statements of operations is related to the individual derivatives as follows: Free standing warrants $ — $ — $ (13,167 ) $ $ — $ (13,167 ) |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 11. Income taxes: The Company did not record income tax expense in 2016, 2015 or 2014 as it had incurred net operating losses. The Company has recognized valuation allowances for all deferred tax assets for years ending 2016, 2015 and 2014. Reconciliation of the Federal statutory income tax rate of 34% to the effective rate is as follows: 2016 2015 2014 Federal statutory income tax rate 34.00 % 34.00 % 34.00 % State taxes, net of federal benefit 2.88 3.45 3.45 Stock compensation (0.61 ) — — Permanent differences-derivative loss — — (9.10 ) Permanent differences-other (1.00 ) (4.66 ) 2.24 Research and development (“R&D”) credit 0.98 0.95 2.73 Other (0.47 ) 0.64 0.61 Increase in valuation allowance (35.78 ) (34.38 ) (33.93 ) 0.00 % 0.00 % 0.00 % The tax effects of temporary differences and net operating losses that give rise to significant components of deferred tax assets and liabilities consist of the following: December 31, Deferred tax assets (liabilities) 2016 2015 Deferred revenue $ 7,377 $ 7,490 Basis difference in equipment (1,084 ) (1,013 ) Basis difference in intangibles 1,201 1,122 Accrued liabilities and other 550 1,563 R&D credit 11,589 11,138 AMT credit 79 — Stock options 5,697 1,151 Net operating loss carry-forward 83,621 63,509 109,030 84,960 Less: valuation allowance (109,030 ) (84,960 ) $ — $ — In accordance with GAAP, the Company is required to reduce any deferred tax asset by a valuation allowance if, based on the weight of available evidence it is more likely than not (a likelihood of more than 50 percent) that some portion or all of the deferred tax assets will not be realized. The valuation allowance should be sufficient to reduce the deferred tax asset to the amount which is more likely than not to be realized. As a result, the Company recorded a valuation allowance with respect to all of the Company’s deferred tax assets. As a result, the change in the valuation allowance for the year ended December 31, 2016 was $24,070. The Company has a federal net operating loss carry forward (“NOLs”) of approximately $225 million as of December 31, 2016. Under Section 382 and 383 of the Internal Revenue Code, if an ownership change occurs with respect to a “loss corporation”, as defined, there are annual limitations on the amount of the NOLs and other deductions which are available to the Company. The portion of the NOLs incurred prior to May 16, 2006 is subject to this limitation. As such, the use of these NOLs to offset taxable income is limited to approximately $1.5 million per year. The Company’s State NOLS are approximately $258 million as of December 31, 2016. These loss carryforwards expire principally beginning in 2020 through 2035 for federal and 2030 for state purposes. Management has evaluated all other tax positions that could have a significant effect on the financial statements and determined that the Company has no uncertain income tax positions at December 31, 2016. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2016 | |
Equity [Abstract] | |
Stockholders' Equity | 12. Stockholders’ equity: 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 the registration statement, the Company established an “at-the-market” 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. On July 2, 2015, the Company filed a shelf registration statement which registered up to $150 million of the Company’s securities for potential future issuance, and such registration statement was declared effective on July 13, 2015. Concurrent with the filing of the registration statement, the Company established an “at-the-market” On December 16, 2015, the Company and Dr. Andrew Finn entered into a retirement agreement (the “Retirement Agreement”) setting forth their mutual understandings regarding Dr. Finn’s retirement from the Company. Pursuant to the Retirement Agreement, all unvested RSUs previously issued under the Company’s equity incentive plans and held by Dr. Finn as of the retirement date were cancelled and, in lieu thereof, Dr. Finn was awarded a one-time Following its review of the Company’s corporate performance for 2015, the Compensation Committee of the Board of Directors approved in early 2016, equity awards for 2015 in the form of RSUs to its named executive officers (including Dr. Finn) and other senior executives in amounts at or below the 25th% percentile of the Company’s peer group. Dr. Finn, who retired on December 31, 2015, received an immediate award of 150,000 shares of Common Stock in fulfillment of the Company’s contractual obligation to him under the Retirement Agreement. Such shares were issued in March 2016. During the years ended December 31, 2016, 2015 and 2014, Company employees, directors and affiliates exercised approximately 0.1 million, 0.2 million and 1.3 million stock options, respectively, with net proceeds to the Company of approximately $0.3 million, 0.8 million and $4.6 million, respectively. Preferred Stock The Company had authorized five million “blank check” shares of $.001 par value convertible preferred stock. On December 3, 2012, the Company closed a registered direct offering, issuance and sale of Series A Preferred. The final amount of Series Preferred issued in the offering was an aggregate of 2,709,300 shares of Series A Preferred. In the event of the Company’s liquidation, dissolution or winding up, holders of the Series A Preferred will receive a payment equal to $.001 per share of Series A Preferred before any proceeds are distributed to the holders of common stock. After the payment of this preferential amount, and subject to the rights of holders of any class or series of capital stock hereafter created specifically ranking by its terms senior to the Series A Preferred, the holders of Series A Preferred will participate ratably in the distribution of any remaining assets with the common stock and any other class or series of our capital stock hereafter created that participates with the common stock in such distributions. At December 31, 2016, 2,093,155 shares of Series A Preferred were outstanding and 2,290,700 shares of “blank check” preferred stock remain authorized but undesignated. During the year ended December 31, 2015, 45,845 shares of Series A Preferred were converted to equal shares of the Company’s common stock. During the year ended December 31, 2014, 570,300 shares of Series A Preferred were converted to equal shares of the Company’s common stock. There were no conversions of Series A Preferred during the year ended December 31, 2016. Restricted Stock Units During the year ended December 31, 2016, 1,703,616 RSUs, were granted to members of the Company’s executive officers, board of directors and employees, with a fair market value of approximately $5.7 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 for executive officers and employees, and vest one-half one-half Restricted stock activity during the year ended December 31, 2016 was as follows: Number of Restricted Shares Weighted Average Fair Market Value Per RSU Outstanding at January 1, 2016 4,298,154 $ 10.23 Granted: Executive officers 805,616 3.80 Directors 185,000 2.43 Employees 713,000 3.64 Vested (592,066 ) 2.68 Forfeitures (92,000 ) 4.14 Conversions (733,407 ) 10.44 Outstanding at December 31, 2016 4,584,797 $ 7.29 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 and of that reserve, 35,000 Performance RSUs were awarded in 2015). No additional Performance RSUs were awarded in 2016. 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 pre-defined 10-K. Stock options The Company has a 2011 Equity Incentive Plan. During the 2015 Annual Meeting of Stockholders (the “Annual Meeting”), stockholders approved an 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 2,250,000 shares from 8,800,000 to 11,050,000. An additional 1,826,442 shares of Common Stock underlying options previously granted under the Company’s Amended and Restated 2001 Incentive Plan remain outstanding and exercisable as of December 31, 2016. The Company’s Amended and Restated 2001 Incentive Plan expired in July 2011 and no new securities may be issued thereunder. Options may be awarded during the ten-year Stock option activity for the years ended December 31, 2016, 2015 and 2014 is as follows: Number of Shares Weighted Average Exercise Price Per Share Aggregate Intrinsic Value Outstanding at January 1, 2014 4,192,927 $ 3.82 $ 9,146 Granted in 2014: Others 420,480 13.86 Exercised (1,332,563 ) 3.48 Forfeitures (84,744 ) 5.26 Outstanding at December 31, 2014 3,196,100 $ 4.32 $ 22,881 Granted in 2015: Others 684,629 8.14 Exercised (235,480 ) 3.52 Forfeitures (247,720 ) 12.65 Outstanding at December 31, 2015 3,397,529 $ 5.42 $ 3,124 Granted in 2016: Officers and Directors 95,000 $ 2.34 Others 558,373 3.12 Exercised (147,425 ) 2.01 Forfeitures (434,486 ) 13.17 Outstanding at December 31, 2016 3,468,991 $ 4.14 $ 0 Options outstanding at December 31, 2016 are as follows: Range of Exercise Prices Number Outstanding Weighted Average Remaining Contractual Life (Years) Weighted Average Exercise Price Aggregate Intrinsic Value $1.00 – 5.00 2,126,448 4.84 $ 2.98 $5.01 – 10.00 1,202,258 3.53 $ 6.52 $10.01 – 15.00 67,250 8.11 $ 13.19 $15.01 – 20.00 73,035 7.76 $ 16.30 3,468,991 $ 0 Options exercisable at December 31, 2016 are as follows: Range of Exercise Prices Number Outstanding Weighted Average Remaining Contractual Life (Years) Weighted Average Exercise Price Aggregate Intrinsic Value $1.00 – 5.00 1,605,457 3.30 $ 3.05 $5.01 – 10.00 960,297 2.26 $ 6.45 $10.01 - 15.00 25,117 8.08 $ 13.27 $15.01 - 48,689 7.76 $ 16.30 2,639,560 $ 0 The weighted average grant date fair value of options granted during the years ended December 31, 2016, 2015 and 2014 was $1.75, $4.99 and $7.18, respectively. There were no options granted during the years ended December 31, 2016, 2015 or 2014 whose exercise price was lower than the estimated market price of the stock at the grant date. Nonvested stock options as of December 31, 2016, and changes during the year then ended, are as follows: Nonvested Shares Shares Weighted Average Grant Date Fair Value Intrinsic Value Nonvested at January 1, 2016 894,345 Granted 653,373 Vested (283,801 ) Forfeited (434,486 ) Nonvested at December 31, 2016 829,431 $ 4.88 $ 0 As of December 31, 2016, there was approximately $13.9 million of unrecognized compensation cost related to unvested share-based compensation awards granted. These costs will be expensed over the next four years. Stock-based compensation During the year ended December 31, 2016, a total of 653,373 options to purchase Common Stock, with an aggregate fair market value of approximately $1.1 million, were granted to Company employees, directors and contractors. The options granted have a term of 10 years from the grant date and vest ratably between a one and three year period. The fair value of each option is amortized as compensation expense evenly through the vesting period. The Company’s stock-based compensation expense is allocated between research and development and selling, general and administrative as follows as of December 31: Stock-based compensation expense 2016 2015 2014 Research and Development $ 2.5 $ 4.2 $ — Selling, General and Administrative $ 12.4 $ 12.8 $ 6.7 Warrants: The Company has granted warrants to purchase shares of Common Stock. Warrants may be granted to affiliates in connection with certain agreements. The Company issued warrants to purchase 357,356 shares of Common Stock at a price of $4.20 in connection with a loan financing in July 2013 (see note 9). The warrants had a fair value of approximately $1 million at the date of the grant. These warrants were exercised during 2014 and are no longer outstanding. During the year ended December 31, 2016, the Company granted warrants to purchase 84,986 shares of Common Stock at an exercise price of $3.53 per share to Midcap and its affiliates in connection with the Company’s extension agreement with MidCap. The warrants were valued using the Black-Scholes Model, which fair value is approximately $0.05 million. As of December 31, 2016, 84,986 warrants remain outstanding. Reclassification of warrants to equity During the year ended December 31, 2014, warrants by various investors were exercised to purchase 2,217,520 shares of Common Stock at prices ranging from $3.12 to $5.00 per share. Until the time of exercise, 1,999,153 of the aforementioned warrants were treated as a derivative liability. Upon exercise of the warrants, these amounts were reclassified to equity based on the fair value on the date of exercise. Earnings Per Share During the year ended December 31, 2016, 2015 and 2014, outstanding stock options, RSUs, warrants and convertible preferred stock of 10,228,929, 9,788,838 and 8,184,460, 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 During the years ended December 31, 2015 and 2014, an executive officer of the Company paid a total of approximately $0.006 million to the Company and three executive officers of the Company paid a total of approximately $0.08 million to the Company, respectively, representing the disgorgement of short swing profits under Section 16(b) under the Exchange Act. The amount was recorded as additional paid-in |
Retirement Plan
Retirement Plan | 12 Months Ended |
Dec. 31, 2016 | |
Compensation and Retirement Disclosure [Abstract] | |
Retirement Plan | 13. Retirement plan: The Company sponsors a defined contribution retirement plan under Section 401(k) of the Internal Revenue Code. The plan covers all employees who meet certain eligibility and participation requirements. Participants may contribute up to 90% of their eligible earnings, as limited by law. The Company makes a matching contribution equal to 100% on the first 5% of participant contributions to the plan. The Company made contributions of approximately $0.4 million, $0.2 million and $0.2 million in years, 2016, 2015 and 2014. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 14. Commitments and contingencies: Operating leases Since November 2007, the Company has leased space for their corporate offices. Lease expense for the corporate office was $0.3 million, $0.3 million and $0.1 million for each of the years ended December 31, 2016, 2015 and 2014, respectively. The Company leased new space for their corporate offices, which began March 2015 for 89 months. The future minimum commitment on the new operating lease at December 31, 2016 is as follows: Years ending December 31, 2017 $ 332 2018 341 2019 351 2020 360 2021 370 Thereafter 219 $ 1,973 Indemnifications The Company’s directors and officers are indemnified against costs and expenses related to stockholder and other claims (i.e., only actions taken in their capacity as officers and directors) that are not covered by the Company’s directors and officers insurance policy. This indemnification is ongoing and does not include a limit on the maximum potential future payments, nor are there any recourse provisions or collateral that may offset the cost. No events have occurred as of December 31, 2016 which would trigger any liability under the agreement. Certain Rights of CDC The Company and CDC IV, LLC (“CDC”) are parties to a Clinical Development and License Agreement, dated July 15, 2005 (as amended, the “CDLA”) pursuant to which CDC has previously provided funds to the Company for the development of the Company’s ONSOLIS ® mid-single ® In September 2007, in connection with CDC’s consent to the North American Meda transaction, the Company, among other transactions with CDC, granted CDC a 1% royalty on net sales of the next BEMA ® ® ® The Company expects to record such royalties as costs of sales occur. In April 2016, CDC exercised its right pursuant to the Royalty Purchase and Amendment Agreement to exchange its royalty rights to the next BEMA ® ® ® ® Litigation Related To ONSOLIS ® On November 2, 2010, MonoSol filed an action against the Company and its commercial partners for ONSOLIS ® ® ® ® ® ® ® The Company strongly refuted as without merit MonoSol’s assertion of patent infringement, which relates to the Company’s confidential, proprietary manufacturing process for ONSOLIS ® In November 2011, the USPTO rejected all 191 claims of MonoSol’s ’588 Patent. On January 20, 2012, the Company filed requests for reexamination before the USPTO of MonoSol’s US patent No 7,357,891 (the ’891 Patent), and No 7,425,292 (the ’292 Patent), the two additional patents asserted by MonoSol, demonstrating that all claims of those two patents 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. The USPTO granted the requests for reexamination with respect to MonoSol’s ’292 and ’891 Patents. In its initial office action in each, the USPTO rejected every claim in each patent. As expected, in the ’891 Patent and ’292 Patent Ex Parte Reexamination proceedings, MonoSol amended the claims several times and made multiple declarations and arguments in an attempt to overcome the rejections made by the USPTO. These amendments, declarations and other statements regarding the claim language significantly narrowed the scope of their claims in these two patents. In the case of the ’891 Patent, not one of the original claims survived reexamination and five separate amendments were filed confirming the Company’s position that the patent was invalid. Additionally, the Company believes that arguments and admissions made by MonoSol prevent it from seeking a broader construction during any subsequent litigation by employing arguments or taking positions that contradict those made during prosecution. A Reexamination Certificate for MonoSol’s ’891 Patent in its amended form was issued August 21, 2012 (Reexamined Patent No. 7,357,891C1 or the ’891C1 Patent). A Reexamination Certificate for MonoSol’s ’292 Patent in its amended form was issued on July 3, 2012 (Reexamined Patent No. 7,425,292C1 or the ’292C1 Patent). These actions by the USPTO confirm the invalidity of the original patents and through the narrowing of the claims in the reissued patents strengthens the Company’s original assertion that its products and technologies do not infringe on MonoSol’s original patents. On June 12, 2013, despite the Company’s previously noted success in the prior ex parte reexaminations for the ’292 and ’891 Patents, the Company filed requests for inter partes reviews (“IPRs”) on the narrowed yet reexamined patents, the ’292 C1 and ’891 C1 Patents, to challenge their validity and continue to strengthen its position. On November 13, 2013, the USPTO decided not to institute the two IPRs for the ’891 C1 and ’292 C1 Patents. The USPTO’s decision was purely on statutory grounds and based on a technicality (in that the IPRs were not filed within what the UPSTO determined to be the statutory period) rather than substantive grounds. Thus, even though the IPRs were not instituted, the USPTO decision preserves the Company rights to raise the same arguments at a later time (e.g., during litigation). Regardless, the Company’s assertion that its products and technologies do not infringe the original ’292 and ’891 Patents and, now, the reexamined ’891 C1 and ’292 C1 Patents remains the same. 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 ® ® ® ® ® ® Litigation Related To BUNAVAIL ® RB and MonoSol On October 29, 2013, Reckitt Benckiser, Inc., RB Pharmaceuticals Limited, and MonoSol (collectively, the RB Plaintiffs) filed an action against the Company relating to its BUNAVAIL ® ® ® 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 ® On September 20, 2014, based upon the Company’s position and belief that its BUNAVAIL ® ® 15-19. inter partes However, in issuing its November 5, 2014 decision not to institute the IPR, the PTAB construed the claims of the ‘378 Patent narrowly. 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. Indeed, given the PTAB’s narrow construction of the claims of the ‘378 Patent, the Company filed a motion to withdraw the ‘378 Patent from the case on December 12, 2014. In addition, the Company also filed a joint motion to continue the stay (with RB Plaintiffs) in the proceedings on the same day. Both the motion to withdraw the ‘378 Patent from the proceedings and motion to continue the stay were granted. On September 22, 2014, the RB Plaintiffs filed an action against the Company (and its commercial partner) relating to the Company’s BUNAVAIL ® ® ® In a related matter, on October 28, 2014, the Company filed multiple IPR requests on the ’167 Patent demonstrating that certain claims of such patent were anticipated by or obvious in light of prior art references, including prior art references not previously considered by the USPTO, and thus, invalid. The USPTO instituted three of the four IPR requests and we filed a request for rehearing for the non-instituted ® On January 22, 2014, MonoSol filed a Petition for IPR on US Patent No. 7,579,019 (the ‘019 Patent). The Petition asserted that the claims of the ‘019 Patent are alleged to be unpatentable over certain prior art references. The IPR was instituted on August 6, 2014. An oral hearing was held in April 2015 and a decision upholding all seven claims was issued August 5, 2015. In September 2015, MonoSol requested that the PTAB rehear the IPR. On December 19, 2016, the PTAB issued a final decision denying MonoSol’s request for rehearing. MonoSol did not file a notice of appeal to the Federal Circuit by February 20, 2017, and therefore, the PTAB’s decision upholding all claims of the Company’s ‘019 patent are final and unappealable. On January 13, 2017, MonoSol filed a complaint in the United States District Court for the District of New Jersey alleging BELBUCA ® Teva Pharmaceuticals (formerly Actavis) On February 8, 2016, the Company received a notice relating to a Paragraph IV certification from Actavis Laboratories UT, Inc. (“Actavis”) seeking to find invalid three Orange Book listed patents (the “Patents”) relating specifically to BUNAVAIL ® ® ® The Company has asserted three different patents against Actavis, the ’019 patent, the ‘866 patent, and the ’177 patent. Actavis did not raise non-infringement non-infringement The Company believes that Actavis is unlikely to prevail on its claims that the ’019, ’866, and ’177 Patents are invalid, and, as the Company has done in the past, intends to vigorously defend its intellectual property. Each of the three patents carry the presumption of validity and, the ‘019 Patent has already been the subject of an unrelated IPR before the USPTO under which the Company, and all claims of the ‘019 Patent survived. MonoSol’s request for rehearing of the final IPR decision regarding the ‘019 Patent was denied by the USPTO on December 19, 2016. MonoSol did not file a timely appeal at the Federal Circuit. On December 20, 2016 the USPTO issued U.S. Patent No. 9,522,188 (“the ’188 patent”), and this patent was properly listed in the Orange Book as covering the BUNAVAIL ® Finally, on January 31, 2017, the Company received a notice relating to a Paragraph IV certification from Teva Pharmaceuticals USA (“Teva”) relating to Teva’s ANDA on additional strengths of BUNAVAIL ® A five (5) day bench trial is currently scheduled to begin on December 4, 2017. Litigation related to BELBUCA ® The Company received notices regarding Paragraph IV certifications from Teva on November 8, 2016, November 10, 2016, and December 22, 2016, seeking to find invalid two Orange Book listed patents (the “Patents”) relating specifically to BELBUCA ® ® ® The Company has asserted two different patents against Teva, the ’019 Patent and the ’866 Patent. Teva did not contest infringement of the claims of the ’019 Patent and also did not contest infringement of the claims of the ’866 Patent that cover BELBUCA ® The Company believes that Teva is unlikely to prevail on its claims that the ’019 and ’866 Patents are invalid, and, as the Company has done in the past, intends to vigorously defend its intellectual property. Both of the patents carry the presumption of validity, and the ’019 Patent has already been the subject of an unrelated IPR before the USPTO under which the Company prevailed, and all claims of the ‘019 Patent survived. MonoSol’s request for rehearing of the final IPR decision regarding the ’019 Patent was denied by the USPTO on December 19, 2016. MonoSol did not file a timely appeal at the Federal Circuit. The parties have requested a five (5) day bench trial to be scheduled for December, 2018. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2016 | |
Subsequent Events [Abstract] | |
Subsequent Events | 15. Subsequent events: Termination Agreement with Endo On December 7, 2016, the Company entered into an agreement (the “Termination Agreement”) with Endo terminating Endo’s licensing of rights for BELBUCA ® ® Upon Closing, the Company will purchase from Endo the following assets (the “Assets”): (i) current BELBUCA ® work-in-progress, ® ® ® ® pre-approval ® work-in-progress pre-Closing The Asset Purchase Price, together with all other payments (including a non-compete covenant payment) due to Endo under the Termination Agreement, will be paid to Endo in cash in four quarterly installments on the last calendar day of each quarter in 2017. The Company is currently evaluating the financial impact of the Termination Agreement in accordance with US GAAP. Furthermore, the Company will not be responsible for future royalties or milestone payments to Endo and Endo will not be obligated to any future milestone payments to the Company. The Termination Agreement contains customary representations and warranties and mutual releases and indemnification. At the Closing, the Company and Endo entered into a Transition Services Agreement which governed the post-Closing rights and responsibilities of the Company and Endo in connection with the license termination and the transfer of the Assets to the Company. Under this agreement, the Company and Endo agreed to the handling of transition matters such as managing customer contracts, BELBUCA ® ® Agreement with Par Pharmaceuticals In conjunction with the aforementioned Endo Termination Agreement, on December 7, 2016, the Company also entered into a distribution agreement (the “Distribution Agreement”) with Par Pharmaceuticals, Inc. (“Par”) for the distribution of an authorized generic BELBUCA ® ® ® one-year two-year one-year ® Term Loan Agreement with CRG On February 21, 2017 (the “Closing Date”), the Company and its wholly-owned subsidiaries, Arius Pharmaceuticals, Inc. (“Arius”) and Arius Two, Inc. (“Arius Two” and collectively with Arius, the “Subsidiary Guarantors”) entered into a Term Loan Agreement (the “Loan Agreement”) with CRG Servicing LLC (“CRG”), as administrative agent and collateral agent, and the lenders named in the Loan Agreement (the “Lenders”). Pursuant to the Loan Agreement, the Company borrowed $45.0 million from the Lenders as of the Closing Date, and may be eligible to borrow up to an additional $30.0 million in two tranches of $15.0 million each contingent upon achievement of certain conditions, including: (i) in the case of the first tranche, representing the second potential draw under the Loan Agreement (the “Second Draw”), satisfying both (a) certain minimum net revenue thresholds on or before September 30, 2017 or December 31, 2017 and (b) a certain minimum market capitalization threshold for a period of time prior to the funding of the Second Draw (provided, that if the Company does not achieve the minimum net revenue thresholds necessary for the Second Draw but does achieve a certain minimum market capitalization threshold for a period of time prior to December 31, 2017, the Company would be eligible for a Second Draw funding in the amount of $5.0 million); and (ii) in the case of the second tranche, representing the third potential draw under the Loan Agreement (the “Third Draw”), satisfying both (a) certain minimum net revenue thresholds on or before June 30, 2018 or September 30, 2018 and (b) a certain minimum market capitalization threshold for a period of time prior to the funding of the Third Draw. The Company utilized approximately $29.4 million of the initial loan proceeds to repay all of the amounts owed by the Company under its existing Amended and Restated Loan and Security Agreement, dated May 29, 2015, with MidCap (the “Prior Agreement”). Upon the repayment of all amounts owed by the Company under the Prior Agreement, all commitments under the Prior Agreement have been terminated and all security interests granted by the Company and the Subsidiary Guarantors to the lenders under the Prior Agreement have been released. The Company intends to use the remainder of the initial loan proceeds (after deducting loan origination costs and broker and other fees) of approximately $14.0 million, plus any additional amounts that may be borrowed in the future, for general corporate purposes and working capital. The Loan Agreement has a six-year term The Company may prepay all or a portion of the outstanding principal and accrued unpaid interest under the Loan Agreement at any time upon prior notice to the Lenders subject to a certain prepayment fees during the first five years of the term (which fees are lowered over time) and no prepayment fee thereafter. In certain circumstances, including a change of control and certain asset sales or licensing transactions, the Company is required to prepay all or a portion of the loan, including the applicable prepayment premium of on the amount of the outstanding principal to be prepaid. As security for its obligations under the Loan Agreement, on the funding date of the initial borrowing, the Company and the Subsidiary Guarantors entered into a security agreement with CRG whereby the Company and the Subsidiary Guarantors granted to CRG, as collateral agent for the Lenders, a lien on substantially all of its assets including intellectual property (subject to certain exceptions). The Loan Agreement requires the Company to maintain minimum cash and cash equivalents balance and, each year through the end of 2022, to meet a minimum net annual revenue threshold. In the event that the Company does not meet the minimum net annual revenue threshold, then the Company can satisfy the requirement for that year by raising two (2) times the shortfall by way of raising equity or subordinated debt. The Loan Agreement also contains customary affirmative and negative covenants for a credit facility of this size and type, including covenants that limit or restrict the Company’s ability to, among other things (but subject in each case to negotiated exceptions), incur indebtedness, grant liens, merge or consolidate, dispose of assets, make investments, make acquisitions, enter into transactions with affiliates, pay dividends or make distributions, license intellectual property rights on an exclusive basis or repurchase stock. The Loan Agreement includes customary events of default that include, among other things, non-payment, inaccuracy In connection with the initial borrowing made under the Loan Agreement on February 21, 2017, the Company issued to CRG and certain of its affiliates five separate warrants to purchase an aggregate of 1,701,582 shares of the Company’s common stock (the “CRG Warrants”). The CRG Warrants are exercisable any time prior to February 21, 2027 at a price of $2.38 per share, with typical provisions for cashless exercise and stock-based anti-dilution protection. The exercise of the CRG Warrants could have a dilutive effect to the Company’s common stock to the extent that the market price per share of the Company’s common stock, as measured under the terms of the CRG Warrants, exceeds the exercise price of the CRG Warrants. CRG is also entitled to receive a smaller amount of similar warrants concurrently with the funding, if applicable, of the Second Draw and the Third Draw. |
Selected Quarterly Results (Una
Selected Quarterly Results (Unaudited) | 12 Months Ended |
Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Results (Unaudited) | SELECTED QUARTERLY RESULTS (UNAUDITED) The following table sets forth certain quarterly financial data for the periods indicated (in thousands, except per share data): Quarter Ended March 31, 2016 June 30, 2016 September 30, 2016 December 31, 2016 Revenue $ 3,040 $ 5,004 $ 3,571 $ 3,931 Gross profit 490 910 1,257 1,631 Loss from operations (17,942 ) (15,594 ) (15,199 ) (15,200 ) Net loss (18,733 ) (16,486 ) (15,977 ) (15,942 ) Basic loss per share (0.35 ) (0.31 ) (0.30 ) (0.29 ) Diluted loss per share (0.35 ) (0.31 ) (0.30 ) (0.29 ) Quarter Ended March 31, 2015 June 30, 2015 September 30, 2015 December 31, 2015 Revenue $ 13,054 $ 1,733 $ 1,235 $ 32,209 Gross profit 11,930 (888 ) (464 ) 29,552 Income (loss) from operations (7,800 ) (18,681 ) (19,652 ) 10,954 Net (loss) income (8,193 ) (19,211 ) (20,439 ) 10,171 Basic (loss) income per share (0.16 ) (0.37 ) (0.39 ) 0.20 Diluted (loss) income per share (0.16 ) (0.37 ) (0.39 ) 0.20 Quarter Ended March 31, 2014 June 30, 2014 September 30, 2014 December 31, 2014 Revenue $ 20,690 $ 13,885 $ 1,822 $ 2,547 Gross profit 19,964 13,198 1,359 (516 ) Income (loss) from operations 713 (2,041 ) (19,059 ) (18,353 ) Net loss (4,644 ) (6,671 ) (25,256 ) (17,647 ) Basic loss per share (0.11 ) (0.14 ) (0.51 ) (0.36 ) Diluted loss per share (0.11 ) (0.14 ) (0.51 ) (0.36 ) |
Valuation and Qualifying Accoun
Valuation and Qualifying Accounts and Reserves | 12 Months Ended |
Dec. 31, 2016 | |
Valuation and Qualifying Accounts [Abstract] | |
Valuation and Qualifying Accounts and Reserves | BIODELIVERY SCIENCES INTERNATIONAL, INC. AND SUBSIDIARIES SCHEDULE II – VALUATION AND QUALIFYING ACCOUNTS AND RESERVES Balance at beginning of the period Charged to income Charged to other accounts Deductions Balance at the end of the period (In thousands) Description Valuation allowance for deferred tax assets Year ended December 31, 2016: $ 84,960 $ — $ 24,070 $ — $ 109,030 Year ended December 31, 2015: $ 72,061 $ — $ 12,899 $ — $ 84,960 Year ended December 31, 2014: $ 53,663 $ — $ 18,398 $ — $ 72,061 Allowance for rebates Year ended December 31, 2016: $ 2,581 $ (613 ) $ 6,615 $ (5,577 ) $ 3,006 Year ended December 31, 2015: $ 231 $ — $ 2,725 $ (375 ) $ 2,581 Year ended December 31, 2014: $ — $ — $ 231 $ — $ 231 Allowance for price adjustments and chargebacks Year ended December 31, 2016: $ 2,272 $ (555 ) $ 6,598 $ (6,876 ) $ 1,439 Year ended December 31, 2015: $ 1,108 $ — $ 6,894 $ (5,730 ) $ 2,272 Year ended December 31, 2014: $ — $ — $ 1,542 $ (434 ) $ 1,108 |
Nature of Business and Summar24
Nature of Business and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Organization | Organization BioDelivery Sciences International, Inc. and subsidiaries (the “Company”) was incorporated in the State of Indiana on January 6, 1997 and reincorporated as a Delaware corporation in 2002. The Company’s subsidiaries are Arius Pharmaceuticals, Inc., a Delaware corporation (“Arius One”) and Arius Two, Inc., a Delaware corporation (“Arius Two”), each of which are wholly-owned, and its majority-owned subsidiary, Bioral Nutrient Delivery, LLC, a Delaware limited liability company (“BND”). The Company is a specialty pharmaceutical company that is leveraging its novel, proprietary and patented drug delivery technologies, including the BioErodible MucoAdhesive (“BEMA ® As used herein, the Company’s common stock, par value $.001 per share, is referred to as the “Common Stock”. |
Principles of consolidation | Principles of consolidation The consolidated financial statements include the accounts of the Company, Arius One, Arius Two and BND. For each period presented BND has been an inactive subsidiary. All significant inter-company balances and transactions have been eliminated. |
Use of estimates in financial statements | Use of estimates in financial statements The preparation of the accompanying consolidated financial statements requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates and assumptions. |
Reclassification | Reclassification Certain amounts within cash flows from operating activities in the Statements of Cash Flows for the year ended December 31, 2014 were reclassified to conform to the current year presentation. In addition, amounts were reclassified between Machinery & Equipment and Idle Equipment in note 4, for the year ended December 31, 2016. The Company also made certain reclassifications in this report’s footnote narratives and tables for the year ending December 31, 2015 to conform to the year ending December 31, 2016 presentation. These reclassifications had no effect on the previously reported net cash flows from operations, activities or net losses. |
Certain Risks, Concentrations and Uncertainties | Certain Risks, Concentrations and Uncertainties The Company relies on certain materials used in its development and third-party manufacturing processes, most of which are procured from two contract manufacturers and two active pharmaceutical ingredient (“API”) suppliers for BUNAVAIL ® ® In addition, the Company utilizes only one contract manufacturer to create the BUNAVAIL ® ® Key components used in the manufacture of ONSOLIS ® The Company sells its BUNAVAIL ® December 31, Customer 2016 2015 Customer A 36 % 40 % Customer B 28 % 33 % Customer C 28 % 16 % Total 92 % 89 % These three customers accounted for 91%, 90% and 88% of total annual sales during the years ended December 31, 2016, 2015 and 2014 respectively. |
Cash | Cash The Company places cash on deposit with financial institutions in the United States. The Federal Deposit Insurance Corporation covers $0.25 million for substantially all depository accounts. The Company may from time to time have amounts on deposit in excess of the insured limits. As of December 31, 2016, the Company had approximately $32.0 million, which exceeded these insured limits. As of December 31, 2015, the Company had approximately $83.6 million, which exceeded these insured limits. |
Accounts Receivable | Accounts Receivable The Company typically requires its customers to remit payments within the first 30 to 37 days, depending on the customer and the products purchased. In addition, the Company offers wholesale distributors a prompt payment discount if they make payments within these deadlines. This discount is generally 2%, but may be higher in some instances due to product launches or customer and/or industry expectations. Because the Company’s wholesale distributors typically take the prompt payment discount, the Company accrues 100% of the prompt payment discounts, based on the gross amount of each invoice, at the time of sale, and the Company applies earned discounts at the time of payment. The allowance for prompt payment discounts was $0.05 million for both of December 31, 2016 and 2015, respectively. The Company performs ongoing credit evaluations and does not require collateral. As appropriate, the Company establishes provisions for potential credit losses. Allowance for doubtful accounts was $0 and $0.02 million as of December 31, 2016 and 2015, respectively. The Company writes off accounts receivable when management determines they are uncollectible and credits payments subsequently received on such receivables to bad debt expense in the period received. Write-offs during the years ending December 31, 2016, 2015 and 2014 were $0.02 million, $0 and $0, respectively. |
Inventory | Inventory Inventories are stated at the lower of cost or market value with costs determined for each batch under the first-in, first-out On a quarterly basis, the Company analyzes its inventory levels and records allowances for inventory that has become obsolete, inventory that has a cost basis in excess of the expected net realizable value and inventory that is in excess of expected demand based upon projected product sales. There were no allowances recorded at December 31, 2016 or 2015. Inventory is composed of the following at December 31: 2016 2015 Raw Materials & Supplies $ 978 $ 443 Work-in-process 1,660 1,216 Finished Goods 730 899 Total Inventories $ 3,368 $ 2,558 |
Property and Equipment | Property and Equipment The Company records property and equipment at cost less accumulated depreciation, which is computed on a straight-line basis over its estimated useful lives, generally 3 to ten years. Due to the postponement of the U.S. relaunch of ONSOLIS ® ® re-tooled, ® |
Intangibles and Goodwill | Intangibles and Goodwill The Company reviews intangible assets with finite lives (“other intangible assets”) for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company uses an estimate of the undiscounted cash flows over the remaining life of its other intangible assets, or related group of assets where applicable, in measuring whether the assets to be held and used will be realizable. In the event of impairment, the Company would discount the future cash flows using its then estimated incremental borrowing rate to estimate the amount of the impairment. There were no impairment charges recognized on finite lived intangibles in 2016, 2015 or 2014. Intangible assets with finite useful lives are amortized over the estimated useful lives as follows: Estimated Useful Lives Licenses 15 years U.S. Product rights 8-12 years EU Product rights 7-11 Goodwill is evaluated for impairment at least annually or more frequently if events or changes in circumstances indicate that the carrying amount may not be recoverable. In the course of the evaluation of the potential impairment of goodwill, either a qualitative or a quantitative assessment may be performed. If a qualitative evaluation determines that it is more likely that not that no impairment exists, then no further analysis is performed. If a qualitative evaluation is unable to determine whether it is more likely than not that impairment has occurred, a quantitative evaluation is performed. The quantitative impairment analysis involves a two-step |
Deferred revenue | Deferred revenue Consistent with the Company’s revenue recognition policy, deferred revenue represents cash received in advance for licensing fees, consulting, research and development services and related supply agreements. Such payments are reflected as deferred revenue until recognized under the Company’s revenue recognition policy. Deferred revenue is classified as current if management believes the Company will be able to recognize the deferred amount as revenue within twelve months of the balance sheet date. The Company is also deferring its sales of BUNAVAIL ® |
Revenue recognition | Revenue recognition Net Product Sales Product Sales- As of December 31, 2016 and 2015, the Company had $1.7 million and $1.9 million of deferred revenue related to sales to wholesalers for which future returns could not be reasonably estimated at the time of sale. Deferred revenue is recognized when the product is sold to the end user, based upon prescriptions filled. To estimate product sold to end users, the Company relies on third-party information, including prescription data and information obtained from significant distributors with respect to their inventory levels and sales to customers. Deferred revenue is recorded net of estimated allowances for rebates, price adjustments, chargebacks, prompt payment and other discounts. Estimated allowances are recorded and classified as accrued expenses in the accompanying balance sheets as of December 31, 2016 and 2015 (see note 3). Product Returns- 18-month ® Rebates- Price Adjustments and Chargebacks- The Company, from time to time, offers certain promotional product-related incentives to its customers. These programs include certain product incentives to pharmacy customers and other sales stocking allowances. The Company has voucher programs for BUNAVAIL ® point-of-sale Prompt Payment Discounts- Gross to Net Accruals- License and Development agreements The Company periodically enters into license and development agreements to develop and commercialize its products. The arrangements typically are multi-deliverable arrangements that are funded through upfront payments, milestone payments and other forms of payment. The Company currently has multiple license and development agreements that are described in notes 6, 7 and 8. Depending on the nature of the contract these revenues are classified as research and development reimbursements or contract revenue. |
Deferred Cost of Sales | Deferred Cost of Sales The Company defers its cost of sales in connection with BUNAVAIL ® |
Cost of Sales | Cost of Sales The cost of sales includes the direct costs attributable to the production of ONSOLIS ® For BUNAVAIL ® ® |
Research and Development Expenses | Research and Development Expenses Research and development expenses consist of product development expenses incurred in identifying, developing and testing product candidates. Product development expenses consist primarily of labor, benefits and related employee expenses for personnel directly involved in product development activities; fees paid to professional service providers for monitoring and analyzing clinical trials; expenses incurred under joint development agreements; regulatory costs; costs of contract research and manufacturing of inventory used in testing and clinical trials; and the cost of facilities used by the Company’s product development personnel. Product development expenses are expensed as incurred and reflect costs directly attributable to product candidates in development during the applicable period and to product candidates for which the Company has discontinued development. Additionally, product development expenses include the cost of qualifying new current Good Manufacturing Practice (“cGMP”) third-party manufacturers for the Company’s product candidates, including expenses associated with any related technology transfer. All indirect costs (such as salaries, benefits or other costs related to the Company’s accounting, legal, human resources, purchasing, information technology and other general corporate functions) associated with individual product candidates are included in general and administrative expenses. |
Advertising | Advertising Advertising costs, which include promotional expenses and the cost of placebo samples, are expensed as incurred. Advertising expenses were $4.2 million, $4.9 million and $4.8 million for the years ended December 31, 2016, 2015 and 2014, respectively, and are included in selling, general and administrative expenses in the accompanying consolidated statements of operations. |
Shipping and Handling Costs | Shipping and Handling Costs Shipping and handling costs are included in selling, general and administrative expenses and totaled $0.01 million, $0.01 million and $0.08 million for the years ended December 31, 2016, 2015 and 2014, respectively. |
Stock-based compensation | Stock-based compensation The Company uses the fair-value based method to determine compensation for all arrangements under which employees and others receive shares of stock or equity instruments (warrants and options). The fair value of each option and warrant is estimated on the date of grant using the Black-Scholes valuation model that uses assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate. Expected volatility is based on historical volatility of the Company’s 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 the contract term. The risk-free rate is based on the U.S. Treasury yield. In applying the Black-Scholes options-pricing model, assumptions are as follows: 2016 2015 2014 Expected price volatility 62.65%-80.78% 73.00%-76.78% 73.00%-78.05% Risk-free interest rate 0.56%-1.70% 1.25%-1.68% 1.58%-1.70% Weighted average expected life in years 6 years 6 years 6 years Dividend yield — — — The Company estimated fair values of derivative financial instruments using the Black-Scholes option valuation technique because it embodied all of the requisite assumptions (including trading volatility, estimated terms and risk free rates) necessary to fairly value these instruments. In addition, option-based techniques were highly volatile and sensitive to changes in the Company’s trading market price which was high-historical volatility. Since derivative financial instruments were initially and subsequently carried at fair values, the Company’s operating results reflected the volatility in these estimates and assumption changes. |
Fair Value of Financial Assets and Liabilities | Fair Value of Financial Instruments with Derivatives The Company measures the fair value of instruments with derivatives in accordance with generally accepted accounting principles of the United States (“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) The Company generally does not use derivative instruments to hedge exposures to cash-flow risks or market-risks that may affect the fair value of its financial instruments. |
Recent accounting pronouncements | Recent accounting pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2014-09, 2016-10, 2016-10 In August 2014, the FASB issued ASU No. 2014-15, 205-40): 2014-15”). 2014-15 The FASB’s new leases standard, ASU 2016-02 2016-02 year-end year-end In March 2016, the FASB issued ASU 2016-09, Improvements 2016-09 2016-09 is In January 2017, the FASB issued ASU 2017-01, Business In January 2017, the FASB issued ASU Update No. 2017-04, Intangibles—Goodwill in-process |
Nature of Business and Summar25
Nature of Business and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Accounting Policies [Abstract] | |
Summary of Company's Customers Accounts Receivable | The following table lists the Company’s customers that individually comprise greater than 10% of total accounts receivable: December 31, Customer 2016 2015 Customer A 36 % 40 % Customer B 28 % 33 % Customer C 28 % 16 % Total 92 % 89 % |
Summary of Inventories | Inventory is composed of the following at December 31: 2016 2015 Raw Materials & Supplies $ 978 $ 443 Work-in-process 1,660 1,216 Finished Goods 730 899 Total Inventories $ 3,368 $ 2,558 |
Intangible Assets with Finite Useful Lives, Amortized Over Estimated Useful Lives | Intangible assets with finite useful lives are amortized over the estimated useful lives as follows: Estimated Useful Lives Licenses 15 years U.S. Product rights 8-12 years EU Product rights 7-11 |
Black Scholes Options-Pricing Model, Assumptions | In applying the Black-Scholes options-pricing model, assumptions are as follows: 2016 2015 2014 Expected price volatility 62.65%-80.78% 73.00%-76.78% 73.00%-78.05% Risk-free interest rate 0.56%-1.70% 1.25%-1.68% 1.58%-1.70% Weighted average expected life in years 6 years 6 years 6 years Dividend yield — — — |
Accounts Payable and Accrued 26
Accounts Payable and Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Payables and Accruals [Abstract] | |
Summary of Components of Accounts Payable and Accrued Liabilities | The following table represents the components of accounts payable and accrued liabilities as of December 31: 2016 2015 Accounts payable $ 9,397 $ 10,177 Accrued price adjustments 592 2,207 Accrued rebates 3,842 2,581 Accrued chargebacks 10 65 Accrued compensation and benefits 2,052 1,917 Accrued royalties 518 431 Accrued clinical trial costs 615 584 Accrued legal 490 — Accrued manufacturing costs 200 183 Accrued sales and marketing costs 193 880 Accrued other 265 476 Total accounts payable and accrued expenses $ 18,174 $ 19,501 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Property, Plant and Equipment [Abstract] | |
Summarized Category of Fixed Assets | Property and equipment, summarized by major category, consist of the following as of December 31: 2016 2015 Machinery & Equipment $ 4,476 $ 580 Computer Equipment & Software 464 460 Office furniture & Equipment 202 200 Leasehold Improvements 53 53 Idle Equipment 1,486 4,983 Total 6,681 6,276 Less Accumulated Depreciation (2,451 ) (2,014 ) Total property, plant & equipment, net $ 4,230 $ 4,262 |
Other Intangible Assets (Tables
Other Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Text Block [Abstract] | |
Summary of Other Intangible Assets Net Consisting of Product Rights and Licenses | Other intangible assets, net, consisting of product rights and licenses are summarized as follows: December 31, 2016 Gross Carrying Value Accumulated Amortization Intangible Assets, net Weighted average Useful Life Product Rights $ 9,050 $ (7,052 ) $ 1,998 9.11 Licenses 1,900 (1,613 ) 287 1.84 Total Intangible Assets $ 10,950 $ (8,665 ) $ 2,285 10.95 December 31, 2015 Gross Carrying Value Accumulated Amortization Intangible Assets, net Weighted average Useful Life Product Rights $ 9,050 $ (6,177 ) $ 2,873 9.13 Licenses 1,900 (1,517 ) 383 1.72 Total Intangible Assets $ 10,950 $ (7,694 ) $ 3,256 10.85 |
Schedule Estimated Aggregate Future Amortization Expenses for Other Intangible Assets | Estimated aggregate future amortization expenses for other intangible assets for each of the next five years and thereafter are as follows: Years ending December 31, 2017 $ 925 2018 657 2019 657 2020 46 $ 2,285 |
Note Payable (Tables)
Note Payable (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Debt Disclosure [Abstract] | |
Future Maturities of CRG Obligation | The following table represents future maturities of the CRG obligation as of February 21, 2017: 2017 $ — 2018 — 2019 — 2020 15,000 2021 15,000 2022 15,000 Total maturities $ 45,000 Unamortized discount and loan costs (6,020 ) Total CRG obligation $ 38,980 |
Derivative Financial Instrume30
Derivative Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Derivative Instruments and Hedging Activities Disclosure [Abstract] | |
Summary of Components of Derivative Financial Instruments | The following tabular presentation reflects the components of derivative financial instruments as of December 31: 2016 2015 2014 Derivative loss in the accompanying statements of operations is related to the individual derivatives as follows: Free standing warrants $ — $ — $ (13,167 ) $ $ — $ (13,167 ) |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Reconciliation of Federal Statutory Income Tax Rate | Reconciliation of the Federal statutory income tax rate of 34% to the effective rate is as follows: 2016 2015 2014 Federal statutory income tax rate 34.00 % 34.00 % 34.00 % State taxes, net of federal benefit 2.88 3.45 3.45 Stock compensation (0.61 ) — — Permanent differences-derivative loss — — (9.10 ) Permanent differences-other (1.00 ) (4.66 ) 2.24 Research and development (“R&D”) credit 0.98 0.95 2.73 Other (0.47 ) 0.64 0.61 Increase in valuation allowance (35.78 ) (34.38 ) (33.93 ) 0.00 % 0.00 % 0.00 % |
Significant Components of Deferred Tax Assets and Liabilities | The tax effects of temporary differences and net operating losses that give rise to significant components of deferred tax assets and liabilities consist of the following: December 31, Deferred tax assets (liabilities) 2016 2015 Deferred revenue $ 7,377 $ 7,490 Basis difference in equipment (1,084 ) (1,013 ) Basis difference in intangibles 1,201 1,122 Accrued liabilities and other 550 1,563 R&D credit 11,589 11,138 AMT credit 79 — Stock options 5,697 1,151 Net operating loss carry-forward 83,621 63,509 109,030 84,960 Less: valuation allowance (109,030 ) (84,960 ) $ — $ — |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Equity [Abstract] | |
Summary of Restricted Stock Activity | Restricted stock activity during the year ended December 31, 2016 was as follows: Number of Restricted Shares Weighted Average Fair Market Value Per RSU Outstanding at January 1, 2016 4,298,154 $ 10.23 Granted: Executive officers 805,616 3.80 Directors 185,000 2.43 Employees 713,000 3.64 Vested (592,066 ) 2.68 Forfeitures (92,000 ) 4.14 Conversions (733,407 ) 10.44 Outstanding at December 31, 2016 4,584,797 $ 7.29 |
Summary of Stock Option Activity | Stock option activity for the years ended December 31, 2016, 2015 and 2014 is as follows: Number of Shares Weighted Average Exercise Price Per Share Aggregate Intrinsic Value Outstanding at January 1, 2014 4,192,927 $ 3.82 $ 9,146 Granted in 2014: Others 420,480 13.86 Exercised (1,332,563 ) 3.48 Forfeitures (84,744 ) 5.26 Outstanding at December 31, 2014 3,196,100 $ 4.32 $ 22,881 Granted in 2015: Others 684,629 8.14 Exercised (235,480 ) 3.52 Forfeitures (247,720 ) 12.65 Outstanding at December 31, 2015 3,397,529 $ 5.42 $ 3,124 Granted in 2016: Officers and Directors 95,000 $ 2.34 Others 558,373 3.12 Exercised (147,425 ) 2.01 Forfeitures (434,486 ) 13.17 Outstanding at December 31, 2016 3,468,991 $ 4.14 $ 0 |
Summary of Stock Options Outstanding | Options outstanding at December 31, 2016 are as follows: Range of Exercise Prices Number Outstanding Weighted Average Remaining Contractual Life (Years) Weighted Average Exercise Price Aggregate Intrinsic Value $1.00 – 5.00 2,126,448 4.84 $ 2.98 $5.01 – 10.00 1,202,258 3.53 $ 6.52 $10.01 – 15.00 67,250 8.11 $ 13.19 $15.01 – 20.00 73,035 7.76 $ 16.30 3,468,991 $ 0 |
Summary of Stock Options Exercisable | Options exercisable at December 31, 2016 are as follows: Range of Exercise Prices Number Outstanding Weighted Average Remaining Contractual Life (Years) Weighted Average Exercise Price Aggregate Intrinsic Value $1.00 – 5.00 1,605,457 3.30 $ 3.05 $5.01 – 10.00 960,297 2.26 $ 6.45 $10.01 - 15.00 25,117 8.08 $ 13.27 $15.01 - 48,689 7.76 $ 16.30 2,639,560 $ 0 |
Summary of Non-Vested Stock Options | Nonvested stock options as of December 31, 2016, and changes during the year then ended, are as follows: Nonvested Shares Shares Weighted Average Grant Date Fair Value Intrinsic Value Nonvested at January 1, 2016 894,345 Granted 653,373 Vested (283,801 ) Forfeited (434,486 ) Nonvested at December 31, 2016 829,431 $ 4.88 $ 0 |
Summary of Allocated Stock-based Compensation Expense | The Company’s stock-based compensation expense is allocated between research and development and selling, general and administrative as follows as of December 31: Stock-based compensation expense 2016 2015 2014 Research and Development $ 2.5 $ 4.2 $ — Selling, General and Administrative $ 12.4 $ 12.8 $ 6.7 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Future Minimum Commitment on the Remaining Operating Lease | The future minimum commitment on the new operating lease at December 31, 2016 is as follows: Years ending December 31, 2017 $ 332 2018 341 2019 351 2020 360 2021 370 Thereafter 219 $ 1,973 |
Selected Quarterly Results (U34
Selected Quarterly Results (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Results | The following table sets forth certain quarterly financial data for the periods indicated (in thousands, except per share data): Quarter Ended March 31, 2016 June 30, 2016 September 30, 2016 December 31, 2016 Revenue $ 3,040 $ 5,004 $ 3,571 $ 3,931 Gross profit 490 910 1,257 1,631 Loss from operations (17,942 ) (15,594 ) (15,199 ) (15,200 ) Net loss (18,733 ) (16,486 ) (15,977 ) (15,942 ) Basic loss per share (0.35 ) (0.31 ) (0.30 ) (0.29 ) Diluted loss per share (0.35 ) (0.31 ) (0.30 ) (0.29 ) Quarter Ended March 31, 2015 June 30, 2015 September 30, 2015 December 31, 2015 Revenue $ 13,054 $ 1,733 $ 1,235 $ 32,209 Gross profit 11,930 (888 ) (464 ) 29,552 Income (loss) from operations (7,800 ) (18,681 ) (19,652 ) 10,954 Net (loss) income (8,193 ) (19,211 ) (20,439 ) 10,171 Basic (loss) income per share (0.16 ) (0.37 ) (0.39 ) 0.20 Diluted (loss) income per share (0.16 ) (0.37 ) (0.39 ) 0.20 Quarter Ended March 31, 2014 June 30, 2014 September 30, 2014 December 31, 2014 Revenue $ 20,690 $ 13,885 $ 1,822 $ 2,547 Gross profit 19,964 13,198 1,359 (516 ) Income (loss) from operations 713 (2,041 ) (19,059 ) (18,353 ) Net loss (4,644 ) (6,671 ) (25,256 ) (17,647 ) Basic loss per share (0.11 ) (0.14 ) (0.51 ) (0.36 ) Diluted loss per share (0.11 ) (0.14 ) (0.51 ) (0.36 ) |
Nature of Business and Summar35
Nature of Business and Summary of Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended | ||
Dec. 31, 2016USD ($)ManufacturerCustomer$ / shares | Dec. 31, 2015USD ($)$ / shares | Dec. 31, 2014USD ($) | |
Basis Of Presentation [Line Items] | |||
Common Stock, par value | $ / shares | $ 0.001 | $ 0.001 | |
Number of contract manufacturers | Manufacturer | 2 | ||
Percentage of amount due to vendors payable | 5.60% | 7.15% | |
Number of customers | Customer | 3 | ||
FDIC insurance coverage | $ 250,000 | ||
Net deposit amount exceeding specified amount under FDIC | $ 32,000,000 | $ 83,600,000 | |
Discount for prompt payment | 2.00% | ||
Percentage of prompt payment discount, accrued | 100.00% | ||
Allowance for prompt payment of discount | $ 50,000 | 50,000 | |
Allowance for Doubtful Accounts Receivable | 0 | 20,000 | |
Allowance for Doubtful Accounts Receivable, Write-offs | 20,000 | 0 | $ 0 |
Inventory allowances recorded | 0 | 0 | |
Impairment loss | 295,000 | ||
Impairment charges recognized on finite lived intangibles assets | 0 | 0 | 0 |
Goodwill impairment charges | 0 | 0 | 0 |
Deferred revenue related to sales | $ 1,700,000 | 1,900,000 | |
Sales return maximum duration | 18 months | ||
Offered period for sales return prior to expiration | 6 months | ||
Offered period for sales return subsequent to expiration | 12 months | ||
Discount for prompt payment | 2.00% | ||
Number of large wholesalers | Customer | 3 | ||
Percentage of accruals accounted by three large wholesalers | 92.00% | ||
Advertising expenses | $ 4,200,000 | 4,900,000 | 4,800,000 |
Shipping and handling costs | $ 10,000 | $ 10,000 | $ 80,000 |
Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | |||
Basis Of Presentation [Line Items] | |||
Total annual sales percentage | 91.00% | 90.00% | 88.00% |
BUNAVAIL [Member] | |||
Basis Of Presentation [Line Items] | |||
Idle equipment net | $ 3,700,000 | ||
Impairment loss | 0 | $ 0 | $ 300,000 |
Deferred cost of sales | 1,700,000 | $ 1,700,000 | |
Onsolis [Member] | |||
Basis Of Presentation [Line Items] | |||
Idle equipment net | $ 1,500,000 | ||
Minimum [Member] | |||
Basis Of Presentation [Line Items] | |||
Period of payments from customers | 30 days | ||
Estimated useful lives of equipment | 3 years | ||
Accrual to payment cycle period | 1 month | ||
Maximum [Member] | |||
Basis Of Presentation [Line Items] | |||
Period of payments from customers | 37 days | ||
Estimated useful lives of equipment | 10 years | ||
Accrual to payment cycle period | 3 months |
Nature of Business and Summar36
Nature of Business and Summary of Significant Accounting Policies - Summary of Company's Customers Accounts Receivable (Detail) - Customer Concentration Risk [Member] - Accounts Receivable [Member] | Dec. 31, 2016 | Dec. 31, 2015 |
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total Accounts Receivable | 92.00% | 89.00% |
Customer A [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total Accounts Receivable | 36.00% | 40.00% |
Customer B [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total Accounts Receivable | 28.00% | 33.00% |
Customer C [Member] | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total Accounts Receivable | 28.00% | 16.00% |
Nature of Business and Summar37
Nature of Business and Summary of Significant Accounting Policies - Summary of Inventories (Detail) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Inventory Disclosure [Abstract] | ||
Raw Materials & Supplies | $ 978 | $ 443 |
Work-in-process | 1,660 | 1,216 |
Finished Goods | 730 | 899 |
Total Inventories | $ 3,368 | $ 2,558 |
Nature of Business and Summar38
Nature of Business and Summary of Significant Accounting Policies - Intangible Assets with Finite Useful Lives, Amortized Over Estimated Useful Lives (Detail) | 12 Months Ended |
Dec. 31, 2016 | |
Licenses [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Estimated Useful Lives | 15 years |
U.S. Product Rights [Member] | Minimum [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Estimated Useful Lives | 8 years |
U.S. Product Rights [Member] | Maximum [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Estimated Useful Lives | 12 years |
Eu Product Rights [Member] | Minimum [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Estimated Useful Lives | 7 years |
Eu Product Rights [Member] | Maximum [Member] | |
Finite-Lived Intangible Assets [Line Items] | |
Estimated Useful Lives | 11 years |
Nature of Business and Summar39
Nature of Business and Summary of Significant Accounting Policies - Black Scholes Options-Pricing Model, Assumptions (Detail) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Dividend yield | 0.00% | 0.00% | 0.00% |
Minimum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected price volatility | 62.65% | 73.00% | 73.00% |
Risk-free interest rate | 0.56% | 1.25% | 1.58% |
Weighted average expected life in years | 6 years | 6 years | 6 years |
Maximum [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected price volatility | 80.78% | 76.78% | 78.05% |
Risk-free interest rate | 1.70% | 1.68% | 1.70% |
Liquidity - Additional Informat
Liquidity - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Liquidity And Managements Plans [Abstract] | ||||
Cash | $ 32,019 | $ 83,560 | $ 70,472 | $ 23,176 |
Cash used | (51,541) | 13,088 | 47,296 | |
Stockholders' (deficit) equity | $ (17,665) | $ 31,696 | $ 54,396 | $ (812) |
Accounts Payable and Accrued 41
Accounts Payable and Accrued Liabilities - Summary of Components of Accounts Payable and Accrued Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Payables and Accruals [Abstract] | ||
Accounts payable | $ 9,397 | $ 10,177 |
Accrued price adjustments | 592 | 2,207 |
Accrued rebates | 3,842 | 2,581 |
Accrued chargebacks | 10 | 65 |
Accrued compensation and benefits | 2,052 | 1,917 |
Accrued royalties | 518 | 431 |
Accrued clinical trial costs | 615 | 584 |
Accrued legal | 490 | |
Accrued manufacturing costs | 200 | 183 |
Accrued sales and marketing costs | 193 | 880 |
Accrued other | 265 | 476 |
Total accounts payable and accrued expenses | $ 18,174 | $ 19,501 |
Accounts payable and Accrued 42
Accounts payable and Accrued Liabilities - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2016Vendor | |
Payables and Accruals [Abstract] | |
Number of vendors | 2 |
Percentage of amount due to major vendors accounts payable | 28.00% |
Property and Equipment - Summar
Property and Equipment - Summarized Category of Fixed Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Property, Plant and Equipment [Line Items] | ||
Property, plant & equipment, gross | $ 6,681 | $ 6,276 |
Less accumulated depreciation | (2,451) | (2,014) |
Total property, plant & equipment, net | 4,230 | 4,262 |
Machinery and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant & equipment, gross | 4,476 | 580 |
Computer Equipment and Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant & equipment, gross | 464 | 460 |
Office Furniture and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant & equipment, gross | 202 | 200 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant & equipment, gross | 53 | 53 |
Idle Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant & equipment, gross | $ 1,486 | $ 4,983 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation | $ 437 | $ 329 | $ 123 |
Other Intangible Assets - Summa
Other Intangible Assets - Summary of Other Intangible Assets Net Consisting of Product Rights and Licenses (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2016 | Dec. 31, 2015 | |
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | $ 10,950 | $ 10,950 |
Accumulated Amortization | (8,665) | (7,694) |
Intangible Assets, net | $ 2,285 | $ 3,256 |
Weighted Average [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Weighted average Useful Life | 10 years 11 months 12 days | 10 years 10 months 6 days |
Product Rights [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | $ 9,050 | $ 9,050 |
Accumulated Amortization | (7,052) | (6,177) |
Intangible Assets, net | $ 1,998 | $ 2,873 |
Product Rights [Member] | Weighted Average [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Weighted average Useful Life | 9 years 1 month 10 days | 9 years 1 month 17 days |
Licenses [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | $ 1,900 | $ 1,900 |
Accumulated Amortization | (1,613) | (1,517) |
Intangible Assets, net | $ 287 | $ 383 |
Weighted average Useful Life | 15 years | |
Licenses [Member] | Weighted Average [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Weighted average Useful Life | 1 year 10 months 2 days | 1 year 8 months 19 days |
Other Intangible Assets - Addit
Other Intangible Assets - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |||
Amortization expense on other intangible assets | $ 971 | $ 970 | $ 972 |
Other Intangible Assets - Sched
Other Intangible Assets - Schedule Estimated Aggregate Future Amortization Expenses for Other Intangible Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2016 | Dec. 31, 2015 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
2,017 | $ 925 | |
2,018 | 657 | |
2,019 | 657 | |
2,020 | 46 | |
Intangible Assets, net | $ 2,285 | $ 3,256 |
License and Development Agree48
License and Development Agreements - Meda License, Development and Supply Agreements - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Nov. 30, 2015 | Oct. 31, 2009 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Revenue Recognition, Milestone Method [Line Items] | |||||
Patent expiration year | 2,020 | ||||
Aggregate milestones and services revenue recognized | $ 20,000,000 | ||||
Contract revenues | $ 2,500,000 | $ 41,759,000 | $ 22,749,000 | ||
U.S. [Member] | |||||
Revenue Recognition, Milestone Method [Line Items] | |||||
Aggregate milestones and services revenue recognized | $ 59,700,000 | ||||
Contract revenues | $ 0 | ||||
U.S. [Member] | Milestones [Member] | |||||
Revenue Recognition, Milestone Method [Line Items] | |||||
Contract revenues | $ 1,000,000 |
License and Development Agree49
License and Development Agreements - Collegium License and Development Agreement - Additional Information (Detail) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | |
Jun. 30, 2016 | Dec. 31, 2016 | Jan. 31, 2012 | |
Revenue Recognition, Milestone Method [Line Items] | |||
Non-refundable payment received | $ 30 | ||
Collegium License and Development Agreement [Member] | |||
Revenue Recognition, Milestone Method [Line Items] | |||
Non-refundable payment received | $ 2.5 | ||
Execution term of license agreement | 30 days | ||
Payment receivable upon first commercial sale | $ 4 | ||
Payment receivable related to patent milestone | 3 | ||
Payment receivable on achievement of potential sales milestones | $ 17 | ||
Royalty payment, term | upper-teen percent royalties payable by Collegium to the Company based on various annual U.S. net sales thresholds, subject to customary adjustments and the royalty sharing arrangements |
License and Development Agree50
License and Development Agreements - Endo License and Development Agreement - Additional Information (Detail) $ in Thousands | Oct. 26, 2015USD ($) | Nov. 30, 2015USD ($) | Oct. 31, 2015USD ($) | Feb. 28, 2015USD ($) | May 31, 2012USD ($) | Dec. 31, 2016USD ($)Clinical_Trials | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Jun. 30, 2014USD ($) | Jan. 31, 2014USD ($) | Jan. 31, 2012USD ($) |
Revenue Recognition, Milestone Method [Line Items] | |||||||||||
Non-refundable payment received | $ 30,000 | ||||||||||
Potential milestone payments on intellectual property rights | $ 15,000 | ||||||||||
Potential payments upon filing and acceptance | $ 10,000 | ||||||||||
Potential milestone payment receivable upon regulatory approval | $ 50,000 | $ 50,000 | |||||||||
Milestone payment upon regulatory approval deferred for future revenue recognition | $ 20,000 | ||||||||||
Patent extension starting period | 2,020 | ||||||||||
Patent extension ending period | 2,027 | ||||||||||
Royalty payment description | $50 million upon regulatory approval, earned in October 2015 and received in November 2015. Of the $50 million received in November 2015, $20 million related to a patent extension and was recorded as deferred revenue because all or a portion of such $20 million was contingently refundable to Endo if a third party generic product was introduced in the U.S. during the patent extension period from 2020 to 2027. However, due to the Company and Endo entering into a Termination Agreement on December 7, 2016 which terminated the BELBUCA® license to Endo effective January 6, 2017, the deferred $20 million will be recognized as revenue in January 2017. (See note 15). | ||||||||||
Recognized up-front payment allocated to the license | $ 15,600 | ||||||||||
Recognized up-front payment to clinical trial material and development services | 14,400 | ||||||||||
Contract revenues | $ 2,500 | $ 41,759 | $ 22,749 | ||||||||
Total rate of reimbursable contractor costs borne | 50.00% | ||||||||||
Deferred revenue from research and development activities | $ 1,134 | 909 | 12,712 | ||||||||
Deferred revenue recognized during the period | 6,000 | 6,000 | |||||||||
Milestone payment receivable remaining revenue | 30,000 | ||||||||||
Clinical Trials Full Enrollment [Member] | |||||||||||
Revenue Recognition, Milestone Method [Line Items] | |||||||||||
Potential milestone payment received, clinical development | $ 20,000 | ||||||||||
Number of clinical trials | Clinical_Trials | 2 | ||||||||||
Clinical Trials One [Member] | |||||||||||
Revenue Recognition, Milestone Method [Line Items] | |||||||||||
Potential milestone payment received, clinical development | $ 10,000 | ||||||||||
Clinical Trials Two [Member] | |||||||||||
Revenue Recognition, Milestone Method [Line Items] | |||||||||||
Potential milestone payment received, clinical development | $ 10,000 | ||||||||||
Endo Agreement [Member] | |||||||||||
Revenue Recognition, Milestone Method [Line Items] | |||||||||||
Contract revenues | $ 0 | 400 | 2,500 | ||||||||
Total rate of reimbursable contractor costs borne | 50.00% | ||||||||||
Reimbursement rate of costs by Endo to the company as per agreement | 100.00% | ||||||||||
Percentage of credit against potential future milestones | 50.00% | ||||||||||
Deferred revenue from research and development activities | $ 0 | $ 900 | $ 12,700 | ||||||||
Endo Agreement [Member] | |||||||||||
Revenue Recognition, Milestone Method [Line Items] | |||||||||||
Deferred revenue refund payment | $ 20,000 | ||||||||||
Termination agreement date | Dec. 7, 2016 | ||||||||||
License termination effective date | Jan. 6, 2017 |
License Obligations - Evonik De
License Obligations - Evonik Definitive Development and Exclusive License Option Agreement - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2016Agreement | |
Definitive Development and Exclusive License Option Agreement [Member] | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |
Number of license agreements granted | 2 |
Other License Agreements and 52
Other License Agreements and Acquired Product Rights - Additional Information (Detail) - USD ($) $ in Thousands | Oct. 04, 2016 | Jun. 30, 2016 | Feb. 04, 2016 | Oct. 07, 2010 | Aug. 31, 2015 | Sep. 30, 2013 | Dec. 31, 2016 |
Kunwha License Agreement [Member] | |||||||
Other License Agreements And Acquired Product Rights [Line Items] | |||||||
Expiration date of the agreement | Aug. 31, 2015 | Jul. 23, 2027 | |||||
Upfront payment | $ 300 | ||||||
Up-front payment net of tax | 250 | ||||||
Milestone payments | 1,300 | ||||||
Milestone payments net of tax | $ 1,100 | ||||||
Milestone payment received | $ 300 | ||||||
TTY License and Supply Agreement [Member] | |||||||
Other License Agreements And Acquired Product Rights [Line Items] | |||||||
Upfront payment | $ 300 | ||||||
Milestone payments | $ 1,300 | ||||||
Milestone payment received | $ 400 | $ 200 | $ 200 | $ 300 | |||
Term of the agreement | 15 years |
Note Payable - Additional Infor
Note Payable - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | Feb. 21, 2017 | May 05, 2016 | May 29, 2015 | Dec. 31, 2016 | Dec. 24, 2016 | Jul. 31, 2016 | Dec. 31, 2014 |
Debt Instrument [Line Items] | |||||||
Number of warrants to purchase common stock | 2,217,520 | ||||||
Mid Cap Financial Trust [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Exercise price of warrants to purchase common stock | $ 3.53 | $ 4.20 | |||||
Mid Cap Financial Trust [Member] | Subsequent Event [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Net proceeds in aggregate amount | $ 29.4 | ||||||
Secured Loan Facility [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Term of loan | 42 months | ||||||
Interest rate | 8.45% | ||||||
LIBOR floor rate | 0.50% | ||||||
Principal payment per month | $ 1 | ||||||
Closing fee from the prior loan | $ 0.4 | ||||||
Final payment fee rate | 2.75% | ||||||
Loan amount prepaid in the first year following execution of credit agreement | 5.00% | ||||||
Loan amount prepaid in each year thereafter | 3.00% | ||||||
Interest rate at period end | 8.95% | ||||||
Exit fee percentage recorded as deferred loan costs | 2.75% | ||||||
Secured Loan Facility [Member] | Mid Cap Financial Trust [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Secured loan facility | 30 | ||||||
Net proceeds in aggregate amount | $ 20.1 | ||||||
Number of warrants to purchase common stock | 84,986 | ||||||
Exercise price of warrants to purchase common stock | $ 3.53 | ||||||
Remaining repayment term of loan | 23 months | ||||||
Total Midcap obligation | $ 29.3 | ||||||
Secured Loan Facility [Member] | Mid Cap Financial Trust [Member] | Subsequent Event [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Net proceeds in aggregate amount | $ 29.4 |
Note Payable - Future Maturitie
Note Payable - Future Maturities of CRG Obligation (Detail) - CRG [Member] - Subsequent Event [Member] $ in Thousands | Feb. 21, 2017USD ($) |
Debt Instrument [Line Items] | |
2,017 | $ 0 |
2,018 | 0 |
2,019 | 0 |
2,020 | 15,000 |
2,021 | 15,000 |
2,022 | 15,000 |
Total maturities | 45,000 |
Unamortized discount and loan costs | (6,020) |
Total CRG obligation | $ 38,980 |
Derivative Financial Instrume55
Derivative Financial Instruments - Summary of Components of Derivative Financial Instruments (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2014USD ($) | |
Derivative Instruments, Gain (Loss) [Line Items] | |
Derivative loss | $ (13,167) |
Free Standing Warrants [Member] | |
Derivative Instruments, Gain (Loss) [Line Items] | |
Derivative loss | $ (13,167) |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | Dec. 31, 2016 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 |
Income Tax [Line Items] | ||||
Federal statutory income tax rate | 34.00% | 34.00% | 34.00% | |
Income tax expense | $ 0 | $ 0 | $ 0 | |
Minimum percentage of likelihood of realization of deferred tax assets | 50.00% | |||
Change in valuation allowance | $ 24,070 | |||
Uncertain income tax position | $ 0 | 0 | ||
Domestic Country [Member] | ||||
Income Tax [Line Items] | ||||
Operating Loss carry forward | 225,000,000 | 225,000,000 | ||
Net operating loss used to offset taxable income | $ 1,500,000 | 1,500,000 | ||
Domestic Country [Member] | Minimum [Member] | ||||
Income Tax [Line Items] | ||||
Operating loss carry forward expiration term | Dec. 31, 2020 | |||
Domestic Country [Member] | Maximum [Member] | ||||
Income Tax [Line Items] | ||||
Operating loss carry forward expiration term | Dec. 31, 2035 | |||
State and Local Jurisdiction [Member] | ||||
Income Tax [Line Items] | ||||
Operating Loss carry forward | $ 258,000,000 | $ 258,000,000 | ||
State and Local Jurisdiction [Member] | Minimum [Member] | ||||
Income Tax [Line Items] | ||||
Operating loss carry forward expiration term | Dec. 31, 2020 | |||
State and Local Jurisdiction [Member] | Maximum [Member] | ||||
Income Tax [Line Items] | ||||
Operating loss carry forward expiration term | Dec. 31, 2030 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Federal Statutory Income Tax Rate (Detail) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Income Tax Disclosure [Abstract] | |||
Federal statutory income tax rate | 34.00% | 34.00% | 34.00% |
State taxes, net of federal benefit | 2.88% | 3.45% | 3.45% |
Stock compensation | (0.61%) | ||
Permanent differences-derivative loss | (9.10%) | ||
Permanent differences-other | (1.00%) | (4.66%) | 2.24% |
Research and development ("R&D") credit | 0.98% | 0.95% | 2.73% |
Other | (0.47%) | 0.64% | 0.61% |
Increase in valuation allowance | (35.78%) | (34.38%) | (33.93%) |
Federal statutory income tax rate, Total | 0.00% | 0.00% | 0.00% |
Income Taxes - Significant Comp
Income Taxes - Significant Components of Deferred Tax Assets and Liabilities (Detail) - USD ($) | Dec. 31, 2016 | Dec. 31, 2015 |
Income Tax Disclosure [Abstract] | ||
Deferred revenue | $ 7,377,000 | $ 7,490,000 |
Basis difference in equipment | (1,084,000) | (1,013,000) |
Basis difference in intangibles | 1,201,000 | 1,122,000 |
Accrued liabilities and other | 550,000 | 1,563,000 |
R&D credit | 11,589,000 | 11,138,000 |
AMT credit | 79,000 | |
Stock options | 5,697,000 | 1,151,000 |
Net operating loss carry-forward | 83,621,000 | 63,509,000 |
Gross, Deferred Tax Assets | 109,030,000 | 84,960,000 |
Less: valuation allowance | (109,030,000) | (84,960,000) |
Net of Valuation Allowance | $ 0 | $ 0 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional information (Detail) | Dec. 16, 2015shares | Jul. 02, 2015USD ($) | Feb. 07, 2014USD ($)$ / sharesshares | Oct. 31, 2014USD ($)shares | Sep. 30, 2014USD ($)shares | Jan. 31, 2014USD ($)shares | Nov. 30, 2013USD ($) | Jul. 11, 2011shares | Dec. 31, 2016USD ($)$ / sharesshares | Dec. 31, 2015USD ($)Executives$ / sharesshares | Dec. 31, 2014USD ($)Executives$ / sharesshares | Dec. 31, 2012shares | Jul. 31, 2016USD ($)$ / sharesshares | Mar. 31, 2016shares | Dec. 31, 2013shares | Dec. 03, 2012$ / sharesshares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||
Common Stock, shares issued | 54,133,511 | 52,730,799 | ||||||||||||||
Proceeds from common stock | $ | $ 2,460,000 | |||||||||||||||
Common Stock, par value | $ / shares | $ 0.001 | $ 0.001 | ||||||||||||||
Company employees, directors and affiliates stock option exercised | 147,425 | 235,480 | 1,332,563 | |||||||||||||
Proceeds from common stock | $ | $ 297,000 | $ 755,000 | $ 4,580,000 | |||||||||||||
Preferred Stock, par value | $ / shares | $ 0.001 | $ 0.001 | ||||||||||||||
Authorized shares of preferred stock | 5,000,000 | 5,000,000 | ||||||||||||||
Number of RSUs vested | 283,801 | |||||||||||||||
Common stock authorized beginning balance | 75,000,000 | 75,000,000 | ||||||||||||||
Weighted average grant date fair value of options granted | $ / shares | $ 1.75 | $ 4.99 | $ 7.18 | |||||||||||||
Number of options granted in period with exercise price below market price | 0 | 0 | 0 | |||||||||||||
Unrecognized compensation cost related to non-vested share-based compensation awards granted | $ | $ 13,900,000 | |||||||||||||||
Unrecognized compensation cost related to non-vested share-based compensation awards granted year | 4 years | |||||||||||||||
Options outstanding | 3,468,991 | 3,397,529 | 3,196,100 | 4,192,927 | ||||||||||||
Warrants exercised to purchase shares of common stock | 2,217,520 | |||||||||||||||
Warrants classified as derivative liabilities | 1,999,153 | |||||||||||||||
Securities excluded from computation of diluted earnings per share | 10,228,929 | 9,788,838 | 8,184,460 | |||||||||||||
Number of executive officers from whom swing profits were recovered | Executives | 1 | 3 | ||||||||||||||
Short swing profits recovered | $ | $ 0 | $ 6,000 | $ 80,000 | |||||||||||||
Dr. Andrew Finn [Member] | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||
Stock issued during period shares upon employee retirement | 513,221 | |||||||||||||||
Issuance of common stock upon employee retirement | 150,000 | |||||||||||||||
Employee retirement date | Dec. 31, 2015 | |||||||||||||||
Directors and Employees [Member] | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||
Number of equity instruments awarded in period | 653,373 | |||||||||||||||
RSU's Vested per performance criteria during period | 3 years | |||||||||||||||
Fair market value of shares granted | $ | $ 1,100,000 | |||||||||||||||
Term of options granted period | 10 years | |||||||||||||||
Definitive Securities Purchase Agreement [Member] | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||
Common Stock, shares issued | 7,500,000 | |||||||||||||||
Proceeds from common stock | $ | $ 58,200,000 | |||||||||||||||
Common Stock, par value | $ / shares | $ 0.001 | |||||||||||||||
Selling price of shares | $ / shares | $ 8 | |||||||||||||||
Offering price per share | 3.10% | |||||||||||||||
Employees and Directors Stock Options [Member] | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||
Company employees, directors and affiliates stock option exercised | 100,000 | 200,000 | 1,300,000 | |||||||||||||
Proceeds from common stock | $ | $ 300,000 | $ 800,000 | $ 4,600,000 | |||||||||||||
Warrant [Member] | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||
Options outstanding | 84,986 | |||||||||||||||
Restricted Stock Units (RSUs) [Member] | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||
Number of equity instruments awarded in period | 1,703,616 | |||||||||||||||
Fair market value of RSUs granted | $ | $ 5,700,000 | |||||||||||||||
Vesting period of options | 3 years | |||||||||||||||
Minimum [Member] | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||
Exercise price of warrants | $ / shares | $ 3.12 | |||||||||||||||
Maximum [Member] | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||
Exercise price of warrants | $ / shares | $ 5 | |||||||||||||||
2011 Equity Incentive Plan [Member] | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||
Increase in shares of common stock authorized | 2,250,000 | |||||||||||||||
2011 Equity Incentive Plan [Member] | Minimum [Member] | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||
Common stock authorized beginning balance | 8,800,000 | |||||||||||||||
2011 Equity Incentive Plan [Member] | Maximum [Member] | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||
Common stock authorized beginning balance | 11,050,000 | |||||||||||||||
Equity Incentive Plan [Member] | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||
Common Stock options outstanding and exercisable | 1,826,442 | |||||||||||||||
Term that options may be awarded | 10 years | |||||||||||||||
LTIP [Member] | Restricted Stock Units (RSUs) [Member] | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||
Number of equity instruments awarded in period | 0 | 35,000 | ||||||||||||||
Restricted stock units ("RSUs") issued to directors and key employees | 1,078,000 | 978,000 | ||||||||||||||
Restricted stock units reserved for future officers | 100,000 | |||||||||||||||
RSU's Vested per performance criteria during period | 8 years | |||||||||||||||
Number of RSUs vested | 13,347 | 21,356 | 4,447 | |||||||||||||
Mid Cap Financial Trust [Member] | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||
Shares of common stock | 84,986 | 357,356 | ||||||||||||||
Exercise price of warrants | $ / shares | $ 3.53 | $ 4.20 | ||||||||||||||
Fair value of warrants | $ | $ 50,000 | $ 1,000,000 | ||||||||||||||
Common Stock [Member] | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||
Company's securities for shelf registration | $ | $ 150,000,000 | $ 75,000,000 | ||||||||||||||
Common Stock, shares issued | 116,911 | 529,010 | 658,489 | |||||||||||||
Proceeds from common stock | $ | $ 1,900,000 | $ 8,700,000 | $ 3,900,000 | |||||||||||||
Universal shelf registration amount, maximum | $ | $ 40,000,000 | $ 15,000,000 | ||||||||||||||
Company employees, directors and affiliates stock option exercised | 147,426 | 223,923 | 1,332,563 | |||||||||||||
Series A Preferred Stock [Member] | ||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||||||
Authorized shares of preferred stock | 2,290,700 | |||||||||||||||
Series A Preferred shares issued | 2,093,155 | 2,709,300 | ||||||||||||||
Liquidation, dissolution or winding up, holders of the Series A Preferred per share payment | $ / shares | $ 0.001 | |||||||||||||||
Series A Preferred stock converted | 0 | 45,845 | 570,300 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Restricted Stock Activity (Detail) - Restricted Stock Units (RSUs) [Member] | 12 Months Ended |
Dec. 31, 2016$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Restricted Shares, Outstanding at beginning of period | 4,298,154 |
Number of Shares, Granted | 1,703,616 |
Number of Restricted Shares, Vested | (592,066) |
Number of Restricted Shares, Forfeitures | (92,000) |
Number of Restricted Shares, Conversions | (733,407) |
Number of Restricted Shares, Outstanding at end of period | 4,584,797 |
Weighted Average Fair Market Value Per RSU, Outstanding at beginning of period | $ / shares | $ 10.23 |
Weighted Average Fair Market Value Per RSU, Vested | $ / shares | 2.68 |
Weighted Average Fair Market Value Per RSU, Forfeitures | $ / shares | 4.14 |
Weighted Average Fair Market Value Per RSU, Conversions | $ / shares | 10.44 |
Weighted Average Fair Market Value Per RSU, Outstanding at end of period | $ / shares | $ 7.29 |
Executive Officer [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares, Granted | 805,616 |
Weighted Average Fair Market Value Per RSU, Granted | $ / shares | $ 3.80 |
Directors [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares, Granted | 185,000 |
Weighted Average Fair Market Value Per RSU, Granted | $ / shares | $ 2.43 |
Employees [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares, Granted | 713,000 |
Weighted Average Fair Market Value Per RSU, Granted | $ / shares | $ 3.64 |
Stockholders' Equity - Summar61
Stockholders' Equity - Summary of Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of Shares, Outstanding at beginning of period | 3,397,529 | 3,196,100 | 4,192,927 |
Number of Shares, Granted | 653,373 | ||
Number of Shares, Exercised | (147,425) | (235,480) | (1,332,563) |
Number of Shares, Forfeitures | (434,486) | (247,720) | (84,744) |
Number of Shares, Outstanding at end of period | 3,468,991 | 3,397,529 | 3,196,100 |
Weighted Average Exercise Price Per Share, Outstanding at beginning of period | $ 5.42 | $ 4.32 | $ 3.82 |
Weighted average Exercise Price Per Share, Exercised | 2.01 | 3.52 | 3.48 |
Weighted Average Exercise Price Per Share, Forfeitures | 13.17 | 12.65 | 5.26 |
Weighted Average Exercise Price Per Share, Outstanding at end of period | $ 4.14 | $ 5.42 | $ 4.32 |
Aggregate Intrinsic Value, Outstanding at beginning of period | $ 3,124 | $ 22,881 | $ 9,146 |
Aggregate Intrinsic Value, Granted | $ 0 | $ 0 | $ 0 |
Aggregate Intrinsic Value, Outstanding at end of period | $ 0 | $ 3,124 | $ 22,881 |
Officers and Directors [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of Shares, Granted | 95,000 | ||
Weighted Average Exercise Price Per Share, Granted | $ 2.34 | ||
Others [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of Shares, Granted | 558,373 | 684,629 | 420,480 |
Weighted Average Exercise Price Per Share, Granted | $ 3.12 | $ 8.14 | $ 13.86 |
Stockholders' Equity - Summar62
Stockholders' Equity - Summary of Stock Options Outstanding (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Number Outstanding | 3,468,991 | |||
Aggregate Intrinsic Value | $ 0 | $ 3,124 | $ 22,881 | $ 9,146 |
$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 Outstanding | 2,126,448 | |||
Weighted Average Remaining Contractual Life (Years) | 4 years 10 months 2 days | |||
Weighted Average Exercise Price | $ 2.98 | |||
$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 Outstanding | 1,202,258 | |||
Weighted Average Remaining Contractual Life (Years) | 3 years 6 months 11 days | |||
Weighted Average Exercise Price | $ 6.52 | |||
$ 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 Outstanding | 67,250 | |||
Weighted Average Remaining Contractual Life (Years) | 8 years 1 month 10 days | |||
Weighted Average Exercise Price | $ 13.19 | |||
$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 Outstanding | 73,035 | |||
Weighted Average Remaining Contractual Life (Years) | 7 years 9 months 4 days | |||
Weighted Average Exercise Price | $ 16.30 |
Stockholders' Equity - Summar63
Stockholders' Equity - Summary of Stock Options Exercisable (Detail) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2016USD ($)$ / sharesshares | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Number Exercisable | shares | 2,639,560 |
Aggregate Intrinsic Value | $ | $ 0 |
$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 | shares | 1,605,457 |
Weighted Average Remaining Contractual Life (Years) | 3 years 3 months 18 days |
Weighted Average Exercise Price | $ 3.05 |
$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 | shares | 960,297 |
Weighted Average Remaining Contractual Life (Years) | 2 years 3 months 4 days |
Weighted Average Exercise Price | $ 6.45 |
$ 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 | shares | 25,117 |
Weighted Average Remaining Contractual Life (Years) | 8 years 29 days |
Weighted Average Exercise Price | $ 13.27 |
$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 | shares | 48,689 |
Weighted Average Remaining Contractual Life (Years) | 7 years 9 months 4 days |
Weighted Average Exercise Price | $ 16.30 |
Stockholders' Equity - Summar64
Stockholders' Equity - Summary of Non-Vested Stock Options (Detail) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2016USD ($)$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Nonvested, Number of Shares [Roll Forward] | |
Nonvested at beginning of period | 894,345 |
Nonvested, Shares, Granted | 653,373 |
Nonvested, Shares, Vested | (283,801) |
Nonvested, Shares, Forfeited | (434,486) |
Nonvested at end of period | 829,431 |
Weighted Average Grant Date Fair Value, Nonvested at December 31, 2016 | $ / shares | $ 4.88 |
Nonvested at December 31, 2016, Aggregate Intrinsic Value | $ | $ 0 |
Stockholders' Equity - Summar65
Stockholders' Equity - Summary of Allocated Stock-based Compensation Expense (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Research and Development [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | $ 2.5 | $ 4.2 | |
Selling, General and Administrative [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | $ 12.4 | $ 12.8 | $ 6.7 |
Retirement Plan - Additional In
Retirement Plan - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Pension Plans, Postretirement and Other Employee Benefits [Line Items] | |||
Employers' sponsors contribution retirement plan | 90.00% | ||
Contribution to retirement plan, percentage of employee contribution | 100.00% | ||
Employers' sponsors contribution retirement plan amount | $ 0.4 | $ 0.2 | $ 0.2 |
Maximum [Member] | |||
Pension Plans, Postretirement and Other Employee Benefits [Line Items] | |||
Percentage of employee contribution to retirement plan | 5.00% |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Contingencies And Commitments [Line Items] | |||
Lease expense | $ 300,000 | $ 300,000 | $ 100,000 |
Lease term | 89 months | ||
CDC [Member] | |||
Contingencies And Commitments [Line Items] | |||
Royalties received | $ 20,000 | ||
Granted royalty on sales of the next BEMA product | 1.00% | ||
Net sales of next BEMA Product | $ 7,500,000 | ||
Minimum [Member] | CDC [Member] | |||
Contingencies And Commitments [Line Items] | |||
Royalties received | $ 375,000 |
Commitments and Contingencies68
Commitments and Contingencies - Future Minimum Commitment on the Remaining Operating Lease (Detail) $ in Thousands | Dec. 31, 2016USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2,017 | $ 332 |
2,018 | 341 |
2,019 | 351 |
2,020 | 360 |
2,021 | 370 |
Thereafter | 219 |
Total operating lease | $ 1,973 |
Subsequent events - Additional
Subsequent events - Additional Information (Detail) | Feb. 21, 2017USD ($)Warrant$ / sharesshares | Dec. 07, 2016 | Dec. 31, 2016$ / shares | Jul. 31, 2016$ / shares | Dec. 31, 2014shares |
Subsequent Event [Line Items] | |||||
Warrants issued to purchase shares of common stock | shares | 2,217,520 | ||||
Mid Cap Financial Trust [Member] | |||||
Subsequent Event [Line Items] | |||||
Warrants exercisable period | $ / shares | $ 3.53 | $ 4.20 | |||
Subsequent Event [Member] | |||||
Subsequent Event [Line Items] | |||||
Remainder of borrowings | $ 14,000,000 | ||||
Subsequent Event [Member] | Mid Cap Financial Trust [Member] | |||||
Subsequent Event [Line Items] | |||||
Amount of initial loan proceeds | 29,400,000 | ||||
Endo Agreement [Member] | |||||
Subsequent Event [Line Items] | |||||
Termination agreement date | Dec. 7, 2016 | ||||
License termination effective date | Jan. 6, 2017 | ||||
Distribution Agreement [Member] | Belbuca [Member] | |||||
Subsequent Event [Line Items] | |||||
Initial Term | 3 years | ||||
Renewal term option for one year | 2 years | ||||
Renewal term option for two years | 1 year | ||||
CRG [Member] | |||||
Subsequent Event [Line Items] | |||||
License termination effective date | Feb. 21, 2017 | ||||
CRG [Member] | Subsequent Event [Member] | |||||
Subsequent Event [Line Items] | |||||
Borrowings outstanding | 45,000,000 | ||||
Additional borrowing capacity upon milestone achievement | 30,000,000 | ||||
Second draw borrowing capacity upon milestone achievement | $ 5,000,000 | ||||
Loan agreement term | 6 years | ||||
Loan agreement interest only term | 3 years | ||||
Loan agreement interest only term threshold | 4 years | ||||
Agreement maturity date | Dec. 31, 2022 | ||||
Interest on borrowings | 12.50% | ||||
Interest on borrowings, interest only period percentage | 3.50% | ||||
Effective interest on borrowings | 9.00% | ||||
Prepayment period of outstanding principal and accrued unpaid interest | 5 years | ||||
Prepayment fee after | $ 0 | ||||
Additional interest rate | 4.00% | ||||
Number of warrants | Warrant | 5 | ||||
Warrants issued to purchase shares of common stock | shares | 1,701,582 | ||||
Warrants exercisable period | $ / shares | $ 2.38 | ||||
CRG [Member] | Subsequent Event [Member] | Tranche One [Member] | |||||
Subsequent Event [Line Items] | |||||
Additional borrowing capacity upon milestone achievement | $ 15,000,000 | ||||
CRG [Member] | Subsequent Event [Member] | Tranche Two [Member] | |||||
Subsequent Event [Line Items] | |||||
Additional borrowing capacity upon milestone achievement | $ 15,000,000 |
Selected Quarterly Results (U70
Selected Quarterly Results (Unaudited) - Selected Quarterly Results (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||||||
Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2015 | Jun. 30, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Selected Quarterly Financial Information [Abstract] | |||||||||||||||
Revenue | $ 3,931 | $ 3,571 | $ 5,004 | $ 3,040 | $ 32,209 | $ 1,235 | $ 1,733 | $ 13,054 | $ 2,547 | $ 1,822 | $ 13,885 | $ 20,690 | $ 15,546 | $ 48,231 | $ 38,944 |
Gross profit | 1,631 | 1,257 | 910 | 490 | 29,552 | (464) | (888) | 11,930 | (516) | 1,359 | 13,198 | 19,964 | |||
Income (loss) from operations | (15,200) | (15,199) | (15,594) | (17,942) | 10,954 | (19,652) | (18,681) | (7,800) | (18,353) | (19,059) | (2,041) | 713 | (63,935) | (35,179) | (38,740) |
Net (loss ) income | $ (15,942) | $ (15,977) | $ (16,486) | $ (18,733) | $ 10,171 | $ (20,439) | $ (19,211) | $ (8,193) | $ (17,647) | $ (25,256) | $ (6,671) | $ (4,644) | $ (67,138) | $ (37,672) | $ (54,218) |
Basic (loss) income per share | $ (0.29) | $ (0.30) | $ (0.31) | $ (0.35) | $ 0.20 | $ (0.39) | $ (0.37) | $ (0.16) | $ (0.36) | $ (0.51) | $ (0.14) | $ (0.11) | |||
Diluted (loss) income per share | $ (0.29) | $ (0.30) | $ (0.31) | $ (0.35) | $ 0.20 | $ (0.39) | $ (0.37) | $ (0.16) | $ (0.36) | $ (0.51) | $ (0.14) | $ (0.11) |
Schedule II - Valuation and Qua
Schedule II - Valuation and Qualifying Accounts and Reserves (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Valuation Allowance of Deferred Tax Assets [Member] | |||
Valuation and Qualifying Accounts Disclosure [Line Items] | |||
Balance at beginning of the period | $ 84,960 | $ 72,061 | $ 53,663 |
Charged to other accounts | 24,070 | 12,899 | 18,398 |
Balance at end of the period | 109,030 | 84,960 | 72,061 |
Allowance For Rebates [Member] | |||
Valuation and Qualifying Accounts Disclosure [Line Items] | |||
Balance at beginning of the period | 2,581 | 231 | |
Charged to income | (613) | ||
Charged to other accounts | 6,615 | 2,725 | 231 |
Deductions | (5,577) | (375) | |
Balance at end of the period | 3,006 | 2,581 | 231 |
Allowance For Price Adjustments And Chargebacks [Member] | |||
Valuation and Qualifying Accounts Disclosure [Line Items] | |||
Balance at beginning of the period | 2,272 | 1,108 | |
Charged to income | (555) | ||
Charged to other accounts | 6,598 | 6,894 | 1,542 |
Deductions | (6,876) | (5,730) | (434) |
Balance at end of the period | $ 1,439 | $ 2,272 | $ 1,108 |