Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2017 | Aug. 09, 2017 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2017 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q2 | |
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 Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 55,475,972 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash | $ 27,508 | $ 32,019 |
Accounts receivable, net | 7,753 | 3,569 |
Inventory, net | 6,564 | 3,368 |
Prepaid expenses and other current assets | 2,657 | 4,136 |
Total current assets | 44,482 | 43,092 |
Property and equipment, net | 4,437 | 4,230 |
Goodwill | 2,715 | 2,715 |
BELBUCA®license and distribution rights intangible | 42,750 | |
Other intangible assets, net | 1,800 | 2,285 |
Total assets | 96,184 | 52,322 |
Current liabilities: | ||
Accounts payable and accrued liabilities | 30,613 | 18,174 |
Deferred revenue, current | 1,716 | |
Total current liabilities | 30,613 | 19,890 |
Notes payable, less current maturities, net | 35,251 | 29,272 |
Deferred revenue, long-term | 20,000 | |
Other long-term liabilities | 4,050 | 825 |
Total liabilities | 69,914 | 69,987 |
Commitments and contingencies (Notes 11 and 15) | ||
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 June 30, 2017 and December 31, 2016, respectively. | 2 | 2 |
Common Stock, $.001 par value; 75,000,000 shares authorized; 55,491,463 and 54,133,511 shares issued; 55,475,972 and 54,118,020 shares outstanding at June 30, 2017 and December 31, 2016, respectively. | 55 | 54 |
Additional paid-in capital | 303,155 | 292,667 |
Treasury stock, at cost, 15,491 shares | (47) | (47) |
Accumulated deficit | (276,895) | (310,341) |
Total stockholders' equity (deficit) | 26,270 | (17,665) |
Total liabilities and stockholders' equity | $ 96,184 | $ 52,322 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2017 | Dec. 31, 2016 |
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 | 55,491,463 | 54,133,511 |
Common Stock, shares outstanding | 55,475,972 | 54,118,020 |
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 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Revenues: | ||||
Product sales | $ 7,886 | $ 2,110 | $ 15,680 | $ 4,212 |
Product royalty revenues | 613 | 394 | 2,273 | 1,328 |
Research and development reimbursements | 245 | 267 | 4 | |
Contract revenues | 2,500 | 20,000 | 2,500 | |
Total Revenues: | 8,744 | 5,004 | 38,220 | 8,044 |
Cost of sales | 4,171 | 4,094 | 9,816 | 6,644 |
Expenses: | ||||
Research and development | 1,590 | 4,008 | 4,260 | 9,385 |
Selling, general and administrative | 15,970 | 12,496 | 29,227 | 25,551 |
Total Expenses: | 17,560 | 16,504 | 33,487 | 34,936 |
Loss from operations | (12,987) | (15,594) | (5,083) | (33,536) |
Interest expense | (1,878) | (914) | (4,764) | (1,691) |
Derivative gain | 22 | 22 | ||
Other expense, net | (14) | (15) | (14) | |
Bargain purchase gain | 27,336 | |||
(Loss) income before income taxes | (14,879) | (16,486) | 17,474 | (35,219) |
Income tax benefit | 15,972 | |||
Net (loss) income attributable to common stockholders | $ (14,879) | $ (16,486) | $ 33,446 | $ (35,219) |
Basic | ||||
Basic (loss) income per share: | $ (0.27) | $ (0.31) | $ 0.61 | $ (0.66) |
Weighted average common stock shares outstanding: | 55,388,774 | 53,594,979 | 54,949,901 | 53,412,813 |
Diluted | ||||
Diluted (loss) income per share: | $ (0.27) | $ (0.31) | $ 0.60 | $ (0.66) |
Diluted weighted average common stock shares outstanding: | 55,388,774 | 53,594,979 | 55,836,769 | 53,412,813 |
Condensed Consolidated Stateme5
Condensed Consolidated Statement of Stockholders' Equity (Deficit) (Unaudited) - 6 months ended Jun. 30, 2017 - 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, 2016 | $ (17,665) | $ 54 | $ 292,667 | $ (47) | $ (310,341) | $ 2 |
Beginning Balance, shares at Dec. 31, 2016 | 54,133,511 | 2,093,155 | ||||
Stock-based compensation | 6,000 | 6,000 | ||||
Restricted stock awards | $ 1 | (1) | ||||
Restricted stock awards, shares | 1,357,952 | |||||
Issuance of warrants | 4,489 | 4,489 | ||||
Net income | 33,446 | 33,446 | ||||
Ending Balance at Jun. 30, 2017 | $ 26,270 | $ 55 | $ 303,155 | $ (47) | $ (276,895) | $ 2 |
Ending Balance, shares at Jun. 30, 2017 | 55,491,463 | 2,093,155 |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows (Unaudited) $ in Thousands | 6 Months Ended | |
Jun. 30, 2017USD ($) | Jun. 30, 2016USD ($) | |
Operating activities: | ||
Net income (loss) | $ 33,446 | $ (35,219) |
Depreciation | 226 | 212 |
Accretion of debt discount and loan costs | 1,491 | 198 |
Amortization of intangible assets | 2,735 | 485 |
Derivative liability | 114 | |
Stock-based compensation expense | 6,000 | 7,457 |
Deferred income taxes | (15,972) | |
Bargain purchase gain | (27,336) | |
Changes in assets and liabilities: | ||
Accounts receivable | (4,183) | 80 |
Inventories, net of effect of acquisition | 2,660 | (1,868) |
Prepaid expenses and other assets | 1,034 | 321 |
Accounts payable and accrued expenses, net of effect of acquisition | 4,904 | (441) |
Deferred revenue | (21,716) | 90 |
Net cash flows from operating activities | (16,711) | (28,571) |
Investing activities: | ||
Purchase of equipment | (2) | (249) |
Net cash flows from investing activities | (2) | (249) |
Financing activities: | ||
Proceeds from notes payable | 45,000 | |
Payment of notes payable | (30,000) | |
Payment of deferred financing fees | (2,798) | |
Equity financing costs | 40 | |
Proceeds from exercise of stock options | 225 | |
Proceeds from issuance of common stock | 2,459 | |
Net cash flows from financing activities | 12,202 | 2,724 |
Net change in cash and cash equivalents | (4,511) | (26,096) |
Cash and cash equivalents at beginning of year | 32,019 | 83,560 |
Cash and cash equivalents at end of period | 27,508 | 57,464 |
Cash paid for interest | 2,373 | $ 1,358 |
Non-cash Operating, Financing and Investing Activities: | ||
Fair value of bargain purchase price of BELBUCA acquisition | 27,300 | |
Fair value of warrants, in connection with CRG term loan | $ 4,500 |
Organization, Basis of Presenta
Organization, Basis of Presentation and Summary of Significant Policies | 6 Months Ended |
Jun. 30, 2017 | |
Accounting Policies [Abstract] | |
Organization, Basis of Presentation and Summary of Significant Policies | 1. Organization, basis of presentation and summary of significant policies: Overview BioDelivery Sciences International, Inc., together with its subsidiaries (collectively, the “Company” or “BDSI”) is a specialty pharmaceutical company that is developing and commercializing, either on its own or in partnerships with third parties, new applications of approved therapeutics to address important unmet medical needs using both proven and new drug delivery technologies. The Company is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction. The accompanying unaudited condensed consolidated financial statements include all adjustments (consisting of normal and recurring adjustments) necessary for a fair presentation of these financial statements. The condensed consolidated balance sheet at December 31, 2016 has been derived from the Company’s audited consolidated financial statements included in its annual report on Form 10-K Form 10-K Operating results for the three and six month periods ended June 30, 2017 are not necessarily indicative of results for the full year or any other future periods. As used herein, the Company’s common stock, par value $.001 per share, is referred to as the “Common Stock.” Principles of consolidation The condensed consolidated financial statements include the accounts of the Company, Arius Pharmaceuticals, Inc. (“Arius”), Arius Two, Inc. (“Arius Two”) and Bioral Nutrient Delivery, LLC (“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 The preparation of the accompanying condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the period. Actual results could differ from those estimates. The Company reviews all significant estimates affecting the consolidated financial statements on a recurring basis and records the effect of any necessary adjustments prior to their issuance. Significant estimates of the Company include: revenue recognition, sales allowances such as returns of product sold, government program rebates, customer coupon redemptions, wholesaler/pharmacy discounts, product service fees, rebates and chargebacks, sales commissions, amortization, stock-based compensation, determination of fair values of assets and liabilities in connection with business combinations, and deferred income taxes. Reacquisition of BELBUCA ® On December 7, 2016, the Company entered into an agreement (the “Termination Agreement”) with Endo Pharmaceuticals, Inc. (“Endo”) terminating Endo’s licensing of rights to the Company’s BELBUCA ® ® ”) ® Inventory Other than the inventory purchased from Endo that remains in inventory at June 30, 2017 and is stated at fair value, inventories are stated at the lower of cost or net realized 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. The Company recorded $0.2 million in inventory allowances as of June 30, 2017. There were no allowances recorded as of December 31, 2016. 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, until January 1, 2017, deferred sales of its BUNAVAIL ® ® ® Revenue recognition Net product sales Beginning in the first quarter of 2017, the Company has determined that it had sufficient experience with BELBUCA ® ® ex-factory ® ® sell-in The Company establishes allowances for estimated rebates, chargebacks and product returns based on numerous qualitative and quantitative factors, including: • the number of and specific contractual terms of agreements with customers; • estimated levels of inventory in the distribution channel; • historical rebates, chargebacks and returns of products; • direct communication with customers; • anticipated introduction of competitive products or generics; • anticipated pricing strategy changes by the Company and/or its competitors; • analysis of prescription data gathered by a third-party prescription data provider; • the impact of changes in state and federal regulations; and • the estimated remaining shelf life of products. In its analyses, the Company uses prescription data purchased from a third-party data provider to develop estimates of historical inventory channel sell-through. The Company utilizes an internal analysis to compare historical net product shipments to estimated historical prescriptions written. Based on that analysis, management develops an estimate of the quantity of product in the channel which may be subject to various rebate, chargeback and product return exposures. To estimate months of ending inventory in the Company’s distribution channel, the Company divides estimated ending inventory in the distribution channel by the Company’s recent prescription data, not taking into account any future anticipated demand growth beyond the succeeding quarter. Monthly for each product line, the Company prepares an internal estimate of ending inventory units in the distribution channel by adding estimated inventory in the channel at the beginning of the period, plus net product shipments for the period, less estimated prescriptions written for the period. This is done for each product line by applying a rate of historical activity for rebates, chargebacks and product returns, adjusted for relevant quantitative and qualitative factors discussed above, to the potential exposed product estimated to be in the distribution channel. 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 BELBUCA ® ® point-of-sale Prompt Payment Discounts Gross to Net Accruals Cost of sales Cost of sales includes the direct costs attributable to the production of BREAKYL ™ ™ out-licensed For BELBUCA ® ® ® ® Recent accounting pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2014-09, 2016-10, 2016-10 The FASB’s new leases standard, ASU 2016-02 2016-02 year-end year-end The Company is currently in the process of evaluating the impact that this new leasing ASU will have on its condensed consolidated financial statements. 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 and Management's Plan
Liquidity and Management's Plans | 6 Months Ended |
Jun. 30, 2017 | |
Text Block [Abstract] | |
Liquidity and Management's Plans | 2. Liquidity and management’s plans: At June 30, 2017, the Company had cash of approximately $27.5 million. The Company used $4.5 million of cash during the six months ended June 30, 2017 and had stockholders’ equity of $26.3 million, versus stockholders’ deficit of $17.7 million at December 31, 2016. The Company expects that it has sufficient cash to manage the business as currently planned into the second half of 2018. 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 ® ® ® out-licensed |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2017 | |
Inventory Disclosure [Abstract] | |
Inventory | 3. Inventory: The following table represents the components of inventory as of: June 30, 2017 December 31, 2016 Raw materials & supplies $ 1,854 $ 978 Work-in-process 2,308 1,660 Finished goods 2,555 730 Finished good reserve (153 ) — Total inventories $ 6,564 $ 3,368 |
Accounts Payable and Accrued Li
Accounts Payable and Accrued Liabilities | 6 Months Ended |
Jun. 30, 2017 | |
Payables and Accruals [Abstract] | |
Accounts Payable and Accrued Liabilities | 4. Accounts payable and accrued liabilities: The following table represents the components of accounts payable and accrued liabilities as of: June 30, 2017 December 31, 2016 Accounts payable $ 9,486 $ 9,397 Accrued price adjustments 2,220 592 Accrued returns 1,022 — Accrued acquisition consideration 6,368 — Accrued rebates 5,843 3,842 Accrued chargebacks 106 10 Accrued compensation and benefits 2,245 2,052 Accrued royalties 661 518 Accrued clinical trial costs 372 615 Accrued legal costs 1,299 490 Accrued manufacturing costs 200 200 Accrued sales and marketing costs — 193 Accrued other 791 265 Total accounts payable and accrued expenses $ 30,613 $ 18,174 |
Property and Equipment
Property and Equipment | 6 Months Ended |
Jun. 30, 2017 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 5. Property and equipment: Property and equipment, summarized by major category, consist of the following as of: June 30, 2017 December 31, 2016 Machinery & equipment $ 4,906 $ 4,476 Computer equipment & software 466 464 Office furniture & equipment 202 202 Leasehold improvements 53 53 Idle equipment 1,486 1,486 Total 7,113 6,681 Less accumulated depreciation (2,676 ) (2,451 ) Total property, plant & equipment, net $ 4,437 $ 4,230 Depreciation expense for the six month periods ended June 30, 2017 and June 30, 2016, was approximately $0.2 million for each period. Depreciation expense for the three month periods ended June 30, 2017 and June 30, 2016, was approximately $0.1 million for each period. |
License and Development Agreeme
License and Development Agreements | 6 Months Ended |
Jun. 30, 2017 | |
Business Combinations [Abstract] | |
License and Development Agreements | 6. License and development agreements: The Company has periodically entered into license and development agreements to develop and commercialize certain of 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 On January 27, 2015, the Company announced that it had entered into an assignment and revenue sharing agreement with Meda AB (“Meda”), a subsidiary of Mylan N.V., to return to the Company the marketing authorization for ONSOLIS ® ® Efforts to extend the Company’s supply agreement with its ONSOLIS ® On May 11, 2016, the Company and 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 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, 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 ® |
Business Combination and Asset
Business Combination and Asset Acquisitions | 6 Months Ended |
Jun. 30, 2017 | |
Business Combinations [Abstract] | |
Business Combination and Asset Acquisitions | 7. Business combination and asset acquisitions: On December 7, 2016, the Company and Endo entered into the Termination Agreement to terminate Endo’s licensing rights for BELBUCA ® ® work-in-progress, ® ® ® ® (v) all pre-approval regulatory ® of work-in-progress inventory, At the closing date, the Company accepted transfer of the net assets and assumed and agreed to discharge when due all applicable liabilities assumed by the Company, which consisted of post-closing obligations for liabilities and payments associated with the net assets, the assumed contracts related to the net assets and applicable taxes (with the obligation for pre-closing non-compete At the closing date, 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 ® ® The BELBUCA ® Business Combinations ® Asset acquisition BELBUCA ® The following table summarizes the consideration paid to acquire BELBUCA ® Asset purchase price: Deferred cash consideration to Endo $ 7,536 Total asset purchase price $ 7,536 Estimated fair value of assets acquired: Current BELBUCA ® work-in $ 5,412 BELBUCA ® 432 License and distribution rights intangible assets 45,000 Deferred tax liability (15,972 ) Amount attributable to assets acquired $ 34,872 Bargain purchase gain $ (27,336 ) Inventories acquired included raw materials, work-in-progress work-in-process, The fair value of the equipment was determined by consultations with a third-party equipment vendor, which considered replacement cost and equipment condition. The equipment will be depreciated over seven years based on its estimated remaining useful life. The fair value of the license and distribution rights intangible assets as amortized in the accompanying condensed consolidated balance sheets were estimated primarily using the “income method,” which starts with a forecast of all expected future cash flows. As such, it is considered level 3 in the fair value hierarchy. Some of the more significant assumptions inherent in the development of intangible asset values, from the perspective of a market participant, include: the amount and timing of projected future cash flows (including net revenue, cost of sales, commercial expenses, research and development costs and working capital requirements) as well as estimated contributory asset charges; the discount rate selected to measure the risks inherent in the future cash flows; and the assessment of the asset’s life cycle and the competitive trends impacting the asset, among other factors. The license and distribution rights intangible assets will be amortized over ten years, which approximates the current, remaining patent life of the BELBUCA ® As a result of the business combination, the Company recognized a deferred tax liability of $16.0 million. This deferred tax liability was netted against its deferred tax assets as of June 30, 2017. Because a full valuation allowance has been provided against the Company’s deferred tax assets as it is considered more likely than not that they will not be utilized, the Company released a corresponding amount of its valuation allowance during the six months ended June 30, 2017 and recognized a $16.0 million tax benefit in the accompanying condensed consolidated statement of operations. The Company recorded the asset acquisition as a bargain purchase gain of $27.3 million in the accompanying condensed consolidated statement of operations. Pro forma impact of acquisition of BELBUCA ® The following pro forma combined results of operations are provided for the year ended December 31, 2016, as though the BELBUCA ® ® ® ® (in thousands, except per share data) December 31, 2016 (unaudited) Revenue $ 25,010 Net loss $ (201,769 ) Pro forma net loss per common share Basic $ (3.76 ) Diluted $ (3.76 ) The Company’s historical financial information was adjusted to give effect to the pro forma events that were directly attributable to the BELBUCA ® • Adjustment to recognize incremental amortization expense based on the fair value of intangibles acquired; • Adjustment to recognize incremental depreciation expense for equipment acquired in the acquisition. |
License Obligations
License Obligations | 6 Months Ended |
Jun. 30, 2017 | |
Text Block [Abstract] | |
License Obligations | 8. License obligations: Evonik 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. This product candidate is currently in the pre-clinical |
Other license agreements and ac
Other license agreements and acquired product rights | 6 Months Ended |
Jun. 30, 2017 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Other license agreements and acquired product rights | 9. Other license agreements and acquired product rights: 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 ® ® In February, March and June 2017, the Company received payments of $0.2 million, $0.03 million and $0.1 million, respectively, from TTY, which related to royalties based on product purchased in Taiwan by TTY of PAINKYL ™ In February 2016 and June 2016, the Company received separate payments of $0.24 million each from TTY which is recorded in the accompanying condensed consolidated statements of operations for the three and six months ended June 30, 2016. |
Note Payable (MidCap loan)
Note Payable (MidCap loan) | 6 Months Ended |
Jun. 30, 2017 | |
Debt Disclosure [Abstract] | |
Note Payable (MidCap loan) | 10. Note payable (MidCap loan): 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 “MidCap Credit Agreement”). On February 21, 2017, the Company entered into a term loan agreement (the “Term Loan Agreement”) with CRG Servicing LLC (“CRG”), as administrative agent and collateral agent, and the lenders named in the Term Loan Agreement (the “Lenders”). The Company utilized approximately $29.4 million of the initial loan proceeds under the Term Loan Agreement to repay all of the amounts owed by the Company under the MidCap Credit Agreement. Upon the repayment of all amounts owed by the Company under the MidCap Credit Agreement, all commitments under the MidCap Credit Agreement were terminated and all security interests granted by the Company and its subsidiary guarantors under the MidCap Credit Agreement were released (see note 11, Term Loan Agreement (CRG)). Certain warrants issued to MidCap and its affiliates in May 2016 related to the extension of the interest only period under the MidCap Credit Agreement remain outstanding as of June 30, 2017 and will expire if not earlier exercised in May, 2021. Such warrants are exercisable for 84,986 shares of Common Stock at an exercise price of $3.53 per share. During the six months ended June 30, 2017, $0.7 million of deferred loan costs arising out of the MidCap Credit Agreement were expensed and recorded as interest expense in the accompanying condensed consolidated statement of operations. |
Term Loan Agreement (CRG)
Term Loan Agreement (CRG) | 6 Months Ended |
Jun. 30, 2017 | |
Debt Disclosure [Abstract] | |
Term Loan Agreement (CRG) | 11. Term loan agreement (CRG): Pursuant to the Term 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 is utilizing the initial proceeds under the Term Loan Agreement (after deducting loan origination costs and broker and other fees) of approximately $13.7 million, plus any additional amounts that may be borrowed in the future, for general corporate purposes and working capital. The Term 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 Term 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 Term 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 of the Company under the Term Loan Agreement (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 Term 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. The Company is in compliance as of June 30, 2017. 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 Term 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 Term Loan Agreement includes customary events of default that include, among other things, non-payment, inaccuracy The following table represents future maturities of the CRG obligation as of June 30, 2017: 2017 $ — 2018 — 2019 — 2020 15,054 2021 15,054 2022 15,054 Total maturities $ 45,162 Unamortized discount and loan costs (9,911 ) Total CRG obligation $ 35,251 In connection with the initial borrowing made under the Term Loan Agreement, the Company issued to CRG and certain of its affiliates five separate warrants to purchase an aggregate of 1,701,583 shares of the 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 Common Stock to the extent that the market price per share of the 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. |
Segment Reporting
Segment Reporting | 6 Months Ended |
Jun. 30, 2017 | |
Segment Reporting [Abstract] | |
Segment Reporting | 12. Segment reporting: The Company operates in a single industry engaging in the development and commercialization of pharmaceutical products principally in the areas of pain management and addiction. Accordingly, the Company’s business is classified as a single reportable segment. The following table presents net sales by product (in thousands): Three months ended June 30, Six months ended June 30, 2017 2016 2017 2016 BELBUCA ® $ 6,563 $ — $ 11,117 $ — BUNAVAIL ® 1,323 2,110 4,563 4,212 Net product sales $ 7,886 $ 2,110 $ 15,680 $ 4,212 |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2017 | |
Equity [Abstract] | |
Stockholders' Equity | 13. Stockholders’ equity: Stock-based compensation During the six months ended June 30, 2017, a total of 807,503 options to purchase Common Stock, with an aggregate fair market value of approximately $1.5 million, were granted to Company employees. The options granted have a term of 10 years from the grant date and vest ratably over a three year period. The fair value of each option is amortized as compensation expense evenly through the vesting period. The Company’s stock-based compensation expense is allocated between research and development and selling, general and administrative as follows: Three months ended, Six months ended, Stock-based compensation expense June 30, 2017 June 30, 2016 June 30, 2017 June 30, 2016 Research and Development $ 0.4 $ 0.5 $ 0.8 $ 1.6 Selling, General and Administrative $ 2.5 $ 2.9 $ 5.2 $ 5.9 The fair value of each option award is estimated on the grant date using the Black-Scholes valuation model that uses assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate. Expected volatilities are based on implied volatilities from historical volatility of the Common Stock, and other factors estimated over the expected term of the options. Expected term of options granted is derived using the “simplified method” which computes expected term as the average of the sum of the vesting term plus contract term. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for the period of the expected term. The weighted average for key assumptions used in determining the fair value of options granted during the six months ended June 30, 2017 follows: Expected price volatility 78.25% - 78.64% Risk-free interest rate 1.82% - 2.01% Weighted average expected life in years 6 years Dividend yield — Option activity during the six months ended June 30, 2017 was as follows: Number of Shares Weighted Average Exercise Price Per Share Aggregate Intrinsic Value Outstanding at January 1, 2017 3,468,991 $ 4.14 Granted in 2017 Officers and Directors — — Others 807,503 1.90 Exercised — — Forfeitures (1,011,979 ) 6.07 Outstanding at June 30, 2017 3,267,515 $ 2.99 $ 1,277 As of June 30, 2017, options exercisable totaled 1,921,093. There was approximately $10.5 million of unrecognized compensation cost related to non-vested Restricted stock units During the six months ended June 30, 2017, 2,180,000 RSUs were granted to the Company’s executive officers and employees, with a fair market value of approximately $4.1 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. Of the aforementioned 2017 RSU grants, 2,060,000 were one-half one-half Number of Restricted Shares Weighted Average Fair Market Value Per RSU Outstanding at January 1, 2017 4,584,297 $ 7.29 Granted: Executive officers 1,640,000 1.80 Directors — — Employees 540,000 2.04 Vested (1,357,952 ) 2.04 Forfeitures (425,676 ) 2.84 Outstanding at June 30, 2017 4,980,669 $ 5.04 Warrants The Company has granted warrants to purchase shares of Common Stock. The fair value of each warrant grant is estimated on the grant date using the Black-Scholes valuation model that uses assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate. Expected volatilities are based on implied volatilities from historical volatility of the Common Stock, and other factors estimated over the expected term of the warrants. Expected term of warrants granted is derived using the “simplified method” which computes expected term as the average of the sum of the vesting term plus contract term. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for the period of the expected term. The weighted average for key assumptions used in determining the fair value of warrants granted during the six months ended June 30, 2017 follows: Expected price volatility 78.39% Risk-free interest rate 1.92% Weighted average expected life in years 6 years Dividend yield — Warrant activity during the six months ended June 30, 2017 was as follows: Number of Shares Weighted Average Exercise Price Per Share Aggregate Intrinsic Value Outstanding at January 1, 2017 84,986 $ 3.53 Granted in 2017 1,701,583 2.38 Exercised — — Forfeitures — — Outstanding at June 30, 2017 1,786,569 $ 2.43 $ — |
Earnings per Common Share
Earnings per Common Share | 6 Months Ended |
Jun. 30, 2017 | |
Earnings Per Share [Abstract] | |
Earnings per Common Share | 14. Earnings per common share: The following table reconciles the numerators and denominators of the basic and diluted loss per share computations (in thousands, except per share data). Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Basic: Net income (loss) $ (14,879 ) $ (16,486 ) $ 33,446 $ (35,219 ) Weighted average common shares outstanding 55,388,774 53,594,979 54,949,901 53,412,813 Basic income (loss) per common share $ (0.27 ) $ (0.31 ) $ 0.61 $ (0.66 ) Diluted: Effect of dilutive securities: Net income (loss) $ (14,879 ) $ (16,486 ) $ 33,446 $ (35,219 ) Weighted average common shares outstanding 55,388,774 53,594,979 54,949,901 53,412,813 Effect of dilutive options and warrants — — 886,868 — Diluted weighted average common shares outstanding 55,388,774 53,594,979 55,836,769 53,412,813 Diluted income (loss) per common share $ (0.27 ) $ (0.31 ) $ 0.60 $ (0.66 ) Basic earnings per common share is calculated using the weighted average shares of Common Stock outstanding during the period. In addition to the weighted average shares of Common Stock outstanding, common equivalent shares from stock options, RSUs and warrants using the treasury stock method, are included in the diluted per share calculations unless the effect of inclusion would be antidilutive. During the three months ended June 30, 2017 and 2016, outstanding stock options, RSUs and warrants of 10,037,017 and 10,113,296, respectively, were not included in the computation of diluted earnings per common share, because to do so would have had an antidilutive effect. During the six months ended June 30, 2017 and 2016, outstanding stock options, RSUs and warrants of 7,747,726 and 10,490,874, respectively, were not included in the computation of diluted earnings per common share, because to do so would have had an antidilutive effect. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 15. Commitments and contingencies: Litigation related to ONSOLIS ® On November 2, 2010, MonoSol Rx LLC (“MonoSol”) filed an action against the Company and its commercial partners for ONSOLIS ® ® ® ® ® ® ® Based on the Company’s original assertion that its proprietary manufacturing process for ONSOLIS ® ® to withdraw the appeal. On February 25, 2016, MonoSol filed an Unopposed Motion For Voluntary Dismissal Of Appeal, which was granted by the court on February 26, 2016 and the case dismissed. Thus, the district court’s grant of the Summary Judgement of Intervening Rights stands. The possibility exists that MonoSol could file another suit alleging infringement of the ’292 and ’891 patents. The Company continues to believe, however, that 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 September 20, 2014, based upon the Company’s position and belief that its BUNAVAIL ® ® inter partes 15-19. On September 22, 2014, the RB Plaintiffs filed an action against the Company (and its commercial partner) relating to its BUNAVAIL ® ® ® commercial partner. The Court issued an opinion on July 21, 2015 granting the Company’s motion to transfer the venue to the ENDC but denying its motion to dismiss the case against the Company’s commercial partner as moot. The Company also filed a Joint Motion to stay the case in North Carolina at the end of April 2016, which was granted by the court on May 5, 2016. Thus, the case is now stayed until a final resolution of the ‘167 IPRs in the USPTO. The Company will continue to vigorously defend this case in the EDNC. 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 the Company filed a request for rehearing for the non-instituted ® 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 “BUNAVAIL ® ® ® ® ® The Company 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 carries 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. IPR petitioner 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 ® 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 ® recently acquired Actavis through an acquisition. On March 16, 2017, the Company brought suit against Teva and its parent company on these additional strengths within 45 days from the receipt of the notice in Delaware. As in the original case brought by Actavis, the Company is again entitled to receive a 30 month stay on the FDA’s ability to give final approval to any proposed products that reference the additional strengths of BUNAVAIL ® Finally, on June 20, 2017, the Court entered orders staying both BUNAVAIL ® Litigations 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 “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. IPR Petitioner 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. A five (5) day bench trial is currently scheduled to begin on November 19, 2018. |
Subsequent events
Subsequent events | 6 Months Ended |
Jun. 30, 2017 | |
Subsequent Events [Abstract] | |
Subsequent events | 16. Subsequent events: On July 12, 2017, the Company, along with Purdue Pharma, an Ontario limited partnership (“Purdue”), announced that they had executed an exclusive agreement granting to Purdue the licensing, distribution, marketing and sale rights related to BELBUCA ® ® ® ® |
Organization, Basis of Presen23
Organization, Basis of Presentation and Summary of Significant Policies (Policies) | 6 Months Ended |
Jun. 30, 2017 | |
Accounting Policies [Abstract] | |
Overview | Overview BioDelivery Sciences International, Inc., together with its subsidiaries (collectively, the “Company” or “BDSI”) is a specialty pharmaceutical company that is developing and commercializing, either on its own or in partnerships with third parties, new applications of approved therapeutics to address important unmet medical needs using both proven and new drug delivery technologies. The Company is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction. The accompanying unaudited condensed consolidated financial statements include all adjustments (consisting of normal and recurring adjustments) necessary for a fair presentation of these financial statements. The condensed consolidated balance sheet at December 31, 2016 has been derived from the Company’s audited consolidated financial statements included in its annual report on Form 10-K Form 10-K Operating results for the three and six month periods ended June 30, 2017 are not necessarily indicative of results for the full year or any other future periods. 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 condensed consolidated financial statements include the accounts of the Company, Arius Pharmaceuticals, Inc. (“Arius”), Arius Two, Inc. (“Arius Two”) and Bioral Nutrient Delivery, LLC (“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 condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the period. Actual results could differ from those estimates. The Company reviews all significant estimates affecting the consolidated financial statements on a recurring basis and records the effect of any necessary adjustments prior to their issuance. Significant estimates of the Company include: revenue recognition, sales allowances such as returns of product sold, government program rebates, customer coupon redemptions, wholesaler/pharmacy discounts, product service fees, rebates and chargebacks, sales commissions, amortization, stock-based compensation, determination of fair values of assets and liabilities in connection with business combinations, and deferred income taxes. |
Reacquisition of BELBUCA | Reacquisition of BELBUCA ® On December 7, 2016, the Company entered into an agreement (the “Termination Agreement”) with Endo Pharmaceuticals, Inc. (“Endo”) terminating Endo’s licensing of rights to the Company’s BELBUCA ® ® ”) ® |
Inventory | Inventory Other than the inventory purchased from Endo that remains in inventory at June 30, 2017 and is stated at fair value, inventories are stated at the lower of cost or net realized 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. The Company recorded $0.2 million in inventory allowances as of June 30, 2017. There were no allowances recorded as of December 31, 2016. |
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, until January 1, 2017, deferred sales of its BUNAVAIL ® ® ® |
Revenue recognition | Revenue recognition Net product sales Beginning in the first quarter of 2017, the Company has determined that it had sufficient experience with BELBUCA ® ® ex-factory ® ® sell-in The Company establishes allowances for estimated rebates, chargebacks and product returns based on numerous qualitative and quantitative factors, including: • the number of and specific contractual terms of agreements with customers; • estimated levels of inventory in the distribution channel; • historical rebates, chargebacks and returns of products; • direct communication with customers; • anticipated introduction of competitive products or generics; • anticipated pricing strategy changes by the Company and/or its competitors; • analysis of prescription data gathered by a third-party prescription data provider; • the impact of changes in state and federal regulations; and • the estimated remaining shelf life of products. In its analyses, the Company uses prescription data purchased from a third-party data provider to develop estimates of historical inventory channel sell-through. The Company utilizes an internal analysis to compare historical net product shipments to estimated historical prescriptions written. Based on that analysis, management develops an estimate of the quantity of product in the channel which may be subject to various rebate, chargeback and product return exposures. To estimate months of ending inventory in the Company’s distribution channel, the Company divides estimated ending inventory in the distribution channel by the Company’s recent prescription data, not taking into account any future anticipated demand growth beyond the succeeding quarter. Monthly for each product line, the Company prepares an internal estimate of ending inventory units in the distribution channel by adding estimated inventory in the channel at the beginning of the period, plus net product shipments for the period, less estimated prescriptions written for the period. This is done for each product line by applying a rate of historical activity for rebates, chargebacks and product returns, adjusted for relevant quantitative and qualitative factors discussed above, to the potential exposed product estimated to be in the distribution channel. 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 BELBUCA ® ® point-of-sale Prompt Payment Discounts Gross to Net Accruals |
Cost of Sales | Cost of sales Cost of sales includes the direct costs attributable to the production of BREAKYL ™ ™ out-licensed For BELBUCA ® ® ® ® |
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 The FASB’s new leases standard, ASU 2016-02 2016-02 year-end year-end The Company is currently in the process of evaluating the impact that this new leasing ASU will have on its condensed consolidated financial statements. 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 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Inventory Disclosure [Abstract] | |
Summary of Inventories | The following table represents the components of inventory as of: June 30, 2017 December 31, 2016 Raw materials & supplies $ 1,854 $ 978 Work-in-process 2,308 1,660 Finished goods 2,555 730 Finished good reserve (153 ) — Total inventories $ 6,564 $ 3,368 |
Accounts Payable and Accrued 25
Accounts Payable and Accrued Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
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: June 30, 2017 December 31, 2016 Accounts payable $ 9,486 $ 9,397 Accrued price adjustments 2,220 592 Accrued returns 1,022 — Accrued acquisition consideration 6,368 — Accrued rebates 5,843 3,842 Accrued chargebacks 106 10 Accrued compensation and benefits 2,245 2,052 Accrued royalties 661 518 Accrued clinical trial costs 372 615 Accrued legal costs 1,299 490 Accrued manufacturing costs 200 200 Accrued sales and marketing costs — 193 Accrued other 791 265 Total accounts payable and accrued expenses $ 30,613 $ 18,174 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Property, Plant and Equipment [Abstract] | |
Summarized Category of Fixed Assets | Property and equipment, summarized by major category, consist of the following as of: June 30, 2017 December 31, 2016 Machinery & equipment $ 4,906 $ 4,476 Computer equipment & software 466 464 Office furniture & equipment 202 202 Leasehold improvements 53 53 Idle equipment 1,486 1,486 Total 7,113 6,681 Less accumulated depreciation (2,676 ) (2,451 ) Total property, plant & equipment, net $ 4,437 $ 4,230 |
Business Combination and Asse27
Business Combination and Asset Acquisitions (Tables) - Belbuca [Member] | 6 Months Ended |
Jun. 30, 2017 | |
Summary of Asset Purchase Price and Estimated Values of Assets Acquired and Liabilities Assumed | The following table summarizes the consideration paid to acquire BELBUCA ® Asset purchase price: Deferred cash consideration to Endo $ 7,536 Total asset purchase price $ 7,536 Estimated fair value of assets acquired: Current BELBUCA ® work-in $ 5,412 BELBUCA ® 432 License and distribution rights intangible assets 45,000 Deferred tax liability (15,972 ) Amount attributable to assets acquired $ 34,872 Bargain purchase gain $ (27,336 ) |
Summary of Proforma Impact of Acquisition | The following pro forma combined results of operations are provided for the year ended December 31, 2016, as though the BELBUCA ® ® ® ® (in thousands, except per share data) December 31, 2016 (unaudited) Revenue $ 25,010 Net loss $ (201,769 ) Pro forma net loss per common share Basic $ (3.76 ) Diluted $ (3.76 ) |
Term Loan Agreement (CRG) (Tabl
Term Loan Agreement (CRG) (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Debt Disclosure [Abstract] | |
Future Maturities of CRG Obligation | The following table represents future maturities of the CRG obligation as of June 30, 2017: 2017 $ — 2018 — 2019 — 2020 15,054 2021 15,054 2022 15,054 Total maturities $ 45,162 Unamortized discount and loan costs (9,911 ) Total CRG obligation $ 35,251 |
Segment Reporting (Tables)
Segment Reporting (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Segment Reporting [Abstract] | |
Summary of net sales by product | The following table presents net sales by product (in thousands): Three months ended June 30, Six months ended June 30, 2017 2016 2017 2016 BELBUCA ® $ 6,563 $ — $ 11,117 $ — BUNAVAIL ® 1,323 2,110 4,563 4,212 Net product sales $ 7,886 $ 2,110 $ 15,680 $ 4,212 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Equity [Abstract] | |
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: Three months ended, Six months ended, Stock-based compensation expense June 30, 2017 June 30, 2016 June 30, 2017 June 30, 2016 Research and Development $ 0.4 $ 0.5 $ 0.8 $ 1.6 Selling, General and Administrative $ 2.5 $ 2.9 $ 5.2 $ 5.9 |
Weighted Average for Key Assumptions Used in Determining Fair Value of Options Granted | The weighted average for key assumptions used in determining the fair value of options granted during the six months ended June 30, 2017 follows: Expected price volatility 78.25% - 78.64% Risk-free interest rate 1.82% - 2.01% Weighted average expected life in years 6 years Dividend yield — |
Summary of Stock Option Activity | Option activity during the six months ended June 30, 2017 was as follows: Number of Shares Weighted Average Exercise Price Per Share Aggregate Intrinsic Value Outstanding at January 1, 2017 3,468,991 $ 4.14 Granted in 2017 Officers and Directors — — Others 807,503 1.90 Exercised — — Forfeitures (1,011,979 ) 6.07 Outstanding at June 30, 2017 3,267,515 $ 2.99 $ 1,277 |
Summary of Restricted Stock Activity | Number of Restricted Shares Weighted Average Fair Market Value Per RSU Outstanding at January 1, 2017 4,584,297 $ 7.29 Granted: Executive officers 1,640,000 1.80 Directors — — Employees 540,000 2.04 Vested (1,357,952 ) 2.04 Forfeitures (425,676 ) 2.84 Outstanding at June 30, 2017 4,980,669 $ 5.04 |
Weighted Average for Key Assumptions Used in Determining Fair Value of Warrants Granted | The weighted average for key assumptions used in determining the fair value of warrants granted during the six months ended June 30, 2017 follows: Expected price volatility 78.39% Risk-free interest rate 1.92% Weighted average expected life in years 6 years Dividend yield — |
Summary of Warrant Activity | Warrant activity during the six months ended June 30, 2017 was as follows: Number of Shares Weighted Average Exercise Price Per Share Aggregate Intrinsic Value Outstanding at January 1, 2017 84,986 $ 3.53 Granted in 2017 1,701,583 2.38 Exercised — — Forfeitures — — Outstanding at June 30, 2017 1,786,569 $ 2.43 $ — |
Earnings per Common Share (Tabl
Earnings per Common Share (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Earnings Per Share [Abstract] | |
Reconciliation of Numerators and Denominators of Basic and Diluted Loss Per Share Computations | The following table reconciles the numerators and denominators of the basic and diluted loss per share computations (in thousands, except per share data). Three Months Ended June 30, Six Months Ended June 30, 2017 2016 2017 2016 Basic: Net income (loss) $ (14,879 ) $ (16,486 ) $ 33,446 $ (35,219 ) Weighted average common shares outstanding 55,388,774 53,594,979 54,949,901 53,412,813 Basic income (loss) per common share $ (0.27 ) $ (0.31 ) $ 0.61 $ (0.66 ) Diluted: Effect of dilutive securities: Net income (loss) $ (14,879 ) $ (16,486 ) $ 33,446 $ (35,219 ) Weighted average common shares outstanding 55,388,774 53,594,979 54,949,901 53,412,813 Effect of dilutive options and warrants — — 886,868 — Diluted weighted average common shares outstanding 55,388,774 53,594,979 55,836,769 53,412,813 Diluted income (loss) per common share $ (0.27 ) $ (0.31 ) $ 0.60 $ (0.66 ) |
Organization, Basis of Presen32
Organization, Basis of Presentation and Summary of Significant Policies - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | Dec. 31, 2016 | |
Basis Of Presentation [Line Items] | |||||
Common Stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | ||
Inventory allowances recorded | $ 200,000 | $ 200,000 | $ 0 | ||
Product sales | $ 7,886,000 | $ 2,110,000 | $ 15,680,000 | $ 4,212,000 | |
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% | 2.00% | |||
Belbuca [Member] | |||||
Basis Of Presentation [Line Items] | |||||
Product sales | $ 6,563,000 | $ 11,117,000 | $ 0 | ||
Endo Agreement [Member] | |||||
Basis Of Presentation [Line Items] | |||||
Termination agreement date | Dec. 7, 2016 | ||||
License termination effective date | Jan. 6, 2017 | ||||
Minimum [Member] | |||||
Basis Of Presentation [Line Items] | |||||
Period of payments from customers | 30 days | ||||
Accrual to payment cycle period | 1 month | ||||
Maximum [Member] | |||||
Basis Of Presentation [Line Items] | |||||
Period of payments from customers | 37 days | ||||
Accrual to payment cycle period | 3 months |
Liquidity and Management's Pl33
Liquidity and Management's Plans - Additional Information (Detail) - USD ($) $ in Thousands | 6 Months Ended | |||
Jun. 30, 2017 | Jun. 30, 2016 | Dec. 31, 2016 | Dec. 31, 2015 | |
Liquidity And Managements Plans [Abstract] | ||||
Cash | $ 27,508 | $ 57,464 | $ 32,019 | $ 83,560 |
Cash generated | (4,511) | $ (26,096) | ||
Stockholders' (deficit) equity | $ 26,270 | $ (17,665) |
Inventory - Summary of Inventor
Inventory - Summary of Inventories (Detail) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Inventory Disclosure [Abstract] | ||
Raw materials & supplies | $ 1,854 | $ 978 |
Work-in-process | 2,308 | 1,660 |
Finished goods | 2,555 | 730 |
Finished good reserve | (153) | |
Total inventories | $ 6,564 | $ 3,368 |
Accounts Payable and Accrued 35
Accounts Payable and Accrued Liabilities - Summary of Components of Accounts Payable and Accrued Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Payables and Accruals [Abstract] | ||
Accounts payable | $ 9,486 | $ 9,397 |
Accrued price adjustments | 2,220 | 592 |
Accrued returns | 1,022 | |
Accrued acquisition consideration | 6,368 | |
Accrued rebates | 5,843 | 3,842 |
Accrued chargebacks | 106 | 10 |
Accrued compensation and benefits | 2,245 | 2,052 |
Accrued royalties | 661 | 518 |
Accrued clinical trial costs | 372 | 615 |
Accrued legal costs | 1,299 | 490 |
Accrued manufacturing costs | 200 | 200 |
Accrued sales and marketing costs | 193 | |
Accrued other | 791 | 265 |
Total accounts payable and accrued expenses | $ 30,613 | $ 18,174 |
Property and Equipment - Summar
Property and Equipment - Summarized Category of Fixed Assets (Detail) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Property, Plant and Equipment [Line Items] | ||
Property, plant & equipment, gross | $ 7,113 | $ 6,681 |
Less accumulated depreciation | (2,676) | (2,451) |
Total property, plant & equipment, net | 4,437 | 4,230 |
Machinery and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant & equipment, gross | 4,906 | 4,476 |
Computer Equipment and Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant & equipment, gross | 466 | 464 |
Office Furniture and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant & equipment, gross | 202 | 202 |
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 | $ 1,486 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation | $ 100 | $ 100 | $ 226 | $ 212 |
License and Development Agree38
License and Development Agreements - Meda License, Development and Supply Agreements - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | Dec. 31, 2016 | Dec. 31, 2015 | |
Revenue Recognition, Milestone Method [Line Items] | |||||
Contract revenues | $ 2,500,000 | $ 20,000,000 | $ 2,500,000 | ||
U.S. [Member] | |||||
Revenue Recognition, Milestone Method [Line Items] | |||||
Contract revenues | $ 0 | ||||
U.S. [Member] | Milestones [Member] | |||||
Revenue Recognition, Milestone Method [Line Items] | |||||
Contract revenues | $ 1,000,000 |
License and Development Agree39
License and Development Agreements - Collegium License and Development Agreement - Additional Information (Detail) - USD ($) $ in Millions | 1 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2017 | Mar. 31, 2017 | 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 Agree40
License and Development Agreements - Endo License and Development Agreement - Additional Information (Detail) $ in Millions | 1 Months Ended | 6 Months Ended | ||||||
Nov. 30, 2015USD ($) | Oct. 31, 2015USD ($) | Feb. 28, 2015USD ($) | May 31, 2012USD ($) | Jun. 30, 2017USD ($)Clinical_Trials | Jun. 30, 2014USD ($) | Jan. 31, 2014USD ($) | Jan. 31, 2012USD ($) | |
Revenue Recognition, Milestone Method [Line Items] | ||||||||
Non-refundable payment received | $ 30 | |||||||
Potential milestone payments on intellectual property rights | $ 15 | |||||||
Potential payments upon filing and acceptance | $ 10 | |||||||
Potential milestone payment receivable upon regulatory approval | $ 50 | |||||||
Milestone payment upon regulatory approval deferred for future revenue recognition | $ 20 | |||||||
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 was recognized as revenue during the six months ended June 30, 2017 in the accompanying condensed consolidated statement of operations (see note 7, Business Combination and Asset Acquisition). | |||||||
Endo Agreement [Member] | ||||||||
Revenue Recognition, Milestone Method [Line Items] | ||||||||
Deferred revenue refund payment | $ 20 | |||||||
Termination agreement date | Dec. 7, 2016 | |||||||
License termination effective date | Jan. 6, 2017 | |||||||
Clinical Trials Full Enrollment [Member] | ||||||||
Revenue Recognition, Milestone Method [Line Items] | ||||||||
Potential milestone payment received, clinical development | $ 20 | |||||||
Number of clinical trials | Clinical_Trials | 2 | |||||||
Clinical Trials One [Member] | ||||||||
Revenue Recognition, Milestone Method [Line Items] | ||||||||
Potential milestone payment received, clinical development | $ 10 | |||||||
Clinical Trials Two [Member] | ||||||||
Revenue Recognition, Milestone Method [Line Items] | ||||||||
Potential milestone payment received, clinical development | $ 10 |
Business Combination and Asse41
Business Combination and Asset Acquisitions - Additional Information (Detail) - USD ($) $ in Thousands | Jan. 06, 2017 | Jun. 30, 2017 |
Business Acquisition [Line Items] | ||
Income tax benefit | $ 15,972 | |
Bargain purchase gain | $ 27,336 | |
Belbuca [Member] | ||
Business Acquisition [Line Items] | ||
Useful life of equipment | 7 years | |
Deferred tax liability | $ (15,972) | |
Income tax benefit | $ 15,972 | |
Bargain purchase gain | $ 27,336 | $ 27,336 |
Belbuca [Member] | License and Distribution Rights [Member] | ||
Business Acquisition [Line Items] | ||
Amortization of intangible asset | 10 years | |
Endo Agreement [Member] | ||
Business Acquisition [Line Items] | ||
Termination agreement date | Dec. 7, 2016 | |
License termination effective date | Jan. 6, 2017 | |
Potential milestone payments on intellectual property rights | $ 5,000 | |
Term of Endo Agreement | 2 years | |
Contract Termination Claims, Description | Together with the Asset Purchase Price, pursuant to the terms of the Termination Agreement, the Company will also pay to Endo a fee in the amount of $5 million in consideration for (i) Endo's agreement not to compete for a period of two years from the closing date of the termination agreement and (ii) Endo's waiver of its right to sell product for twelve months following the closing of the termination agreement. |
Business Combination and Asse42
Business Combination and Asset Acquisitions - Summary of Asset Purchase Price and Estimated Values of Assets Acquired and Liabilities Assumed (Detail) - USD ($) $ in Thousands | Jan. 06, 2017 | Jun. 30, 2017 |
Estimated fair value of assets acquired: | ||
Bargain purchase gain | $ (27,336) | |
Belbuca [Member] | ||
Asset purchase price: | ||
Deferred cash consideration to Endo | $ 7,536 | |
Total asset purchase price | 7,536 | |
Estimated fair value of assets acquired: | ||
Current BELBUCA® product inventory and work-in process | 5,412 | |
BELBUCA®-related manufacturing equipment | 432 | |
License and distribution rights intangible assets | 45,000 | |
Deferred tax liability | (15,972) | |
Amount attributable to assets acquired | 34,872 | |
Bargain purchase gain | $ (27,336) | $ (27,336) |
Business Combination and Asse43
Business Combination and Asset Acquisitions - Summary of Proforma Impact of Acquisition (Detail) - Belbuca [Member] $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2016USD ($)$ / shares | |
Business Acquisition [Line Items] | |
Revenue | $ | $ 25,010 |
Net loss | $ | $ (201,769) |
Pro forma net loss per common share | |
Basic | $ / shares | $ (3.76) |
Diluted | $ / shares | $ (3.76) |
Other License Agreements and 44
Other License Agreements and Acquired Product Rights - Additional Information (Detail) - TTY License and Supply Agreement [Member] - USD ($) $ in Thousands | Oct. 07, 2010 | Jun. 30, 2017 | Mar. 31, 2017 | Feb. 28, 2017 | Jun. 30, 2016 | Feb. 28, 2016 | Jun. 30, 2017 |
Other License Agreements And Acquired Product Rights [Line Items] | |||||||
Upfront payment | $ 300 | ||||||
Milestone payments | $ 1,300 | ||||||
Term of the agreement | 15 years | ||||||
Milestone payment received | $ 100 | $ 30 | $ 200 | $ 240 | $ 240 |
Note Payable (MidCap Loan) - Ad
Note Payable (MidCap Loan) - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | Feb. 21, 2017 | Jun. 30, 2017 | May 29, 2015 |
CRG [Member] | |||
Debt Instrument [Line Items] | |||
License termination effective date | Feb. 21, 2017 | ||
Number of warrants to purchase common stock | 1,701,583 | ||
Exercise price of warrants to purchase common stock | $ 2.38 | ||
Secured Loan Facility [Member] | Mid Cap Financial Trust [Member] | |||
Debt Instrument [Line Items] | |||
Secured loan facility | $ 30 | ||
Net proceeds in aggregate amount | $ 29.4 | ||
Number of warrants to purchase common stock | 84,986 | ||
Exercise price of warrants to purchase common stock | $ 3.53 | ||
Class Of Warrant Or Rights Date From Which Warrants Or Rights Expired | 2021-05 | ||
Interest Expense [Member] | Mid Cap Financial Trust [Member] | |||
Debt Instrument [Line Items] | |||
Deferred loan costs expensed | $ 0.7 |
Term Loan Agreement (CRG) - Add
Term Loan Agreement (CRG) - Additional Information (Detail) | Feb. 21, 2017USD ($)Warrant$ / sharesshares |
Debt Instrument [Line Items] | |
Remainder of borrowings | $ 13,700,000 |
CRG [Member] | |
Debt Instrument [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% |
Final payment fee rate | 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 | 1,701,583 |
Warrants exercisable period | $ / shares | $ 2.38 |
CRG [Member] | Tranche One [Member] | |
Debt Instrument [Line Items] | |
Additional borrowing capacity upon milestone achievement | $ 15,000,000 |
CRG [Member] | Tranche Two [Member] | |
Debt Instrument [Line Items] | |
Additional borrowing capacity upon milestone achievement | $ 15,000,000 |
Term Loan Agreement (CRG) - Fut
Term Loan Agreement (CRG) - Future Maturities of CRG Obligation (Detail) - CRG [Member] $ in Thousands | Jun. 30, 2017USD ($) |
Debt Instrument [Line Items] | |
2,017 | $ 0 |
2,018 | 0 |
2,019 | 0 |
2,020 | 15,054 |
2,021 | 15,054 |
2,022 | 15,054 |
Total maturities | 45,162 |
Unamortized discount and loan costs | (9,911) |
Total CRG obligation | $ 35,251 |
Segment Reporting - Additional
Segment Reporting - Additional Information (Detail) | 6 Months Ended |
Jun. 30, 2017Segment | |
Segment Reporting [Abstract] | |
Number of reportable segment | 1 |
Segment Reporting - Summary of
Segment Reporting - Summary of Net Sales by Product (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | Dec. 31, 2016 | |
Sales Information [Line Items] | |||||
Net product sales | $ 7,886 | $ 2,110 | $ 15,680 | $ 4,212 | |
Belbuca [Member] | |||||
Sales Information [Line Items] | |||||
Net product sales | 6,563 | 11,117 | $ 0 | ||
BUNAVAIL [Member] | |||||
Sales Information [Line Items] | |||||
Net product sales | $ 1,323 | $ 2,110 | $ 4,563 | $ 4,212 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional information (Detail) $ in Millions | 6 Months Ended |
Jun. 30, 2017USD ($)shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Unrecognized compensation cost related to non-vested share-based compensation awards granted | $ | $ 10.5 |
Unrecognized compensation cost related to non-vested share-based compensation awards granted year | 2,020 |
Stock option exercisable | 1,921,093 |
Restricted Stock Units (RSUs) [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of equity instruments awarded in period | 2,180,000 |
Fair market value of RSUs granted | $ | $ 4.1 |
Restricted Stock Units (RSUs) [Member] | Share-based Compensation Award, Tranche One [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of equity instruments awarded in period | 2,060,000 |
Vesting period of shares | 3 years |
Restricted Stock Units (RSUs) [Member] | Time-Based [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Percentage of vesting | 50.00% |
Restricted Stock Units (RSUs) [Member] | Performance-Based [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Percentage of vesting | 50.00% |
Restricted Stock Units (RSUs) [Member] | Share-based Compensation Award, Tranche Two [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of equity instruments awarded in period | 120,000 |
Vesting period of shares | 1 year |
Employees [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of equity instruments awarded in period | 807,503 |
Fair market value of shares granted | $ | $ 1.5 |
Term of options granted period | 10 years |
Vesting period of shares | 3 years |
Employees [Member] | Restricted Stock Units (RSUs) [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of equity instruments awarded in period | 540,000 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Allocated Stock-based Compensation Expense (Detail) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Research and Development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 0.4 | $ 0.5 | $ 0.8 | $ 1.6 |
Selling, General and Administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Stock-based compensation expense | $ 2.5 | $ 2.9 | $ 5.2 | $ 5.9 |
Stockholders' Equity - Weighted
Stockholders' Equity - Weighted Average for Key Assumptions Used in Determining Fair Value of Options Granted (Detail) | 6 Months Ended |
Jun. 30, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Weighted average expected life in years | 6 years |
Dividend yield | 0.00% |
Minimum [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Expected price volatility | 78.25% |
Risk-free interest rate | 1.82% |
Maximum [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Expected price volatility | 78.64% |
Risk-free interest rate | 2.01% |
Stockholders' Equity - Summar53
Stockholders' Equity - Summary of Stock Option Activity (Detail) $ / shares in Units, $ in Thousands | 6 Months Ended |
Jun. 30, 2017USD ($)$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares, Outstanding at beginning of period | shares | 3,468,991 |
Number of Shares, Exercised | shares | 0 |
Number of Shares, Forfeitures | shares | (1,011,979) |
Number of Shares, Outstanding at end of period | shares | 3,267,515 |
Weighted Average Exercise Price Per Share, Outstanding at beginning of period | $ / shares | $ 4.14 |
Weighted average Exercise Price Per Share, Exercised | $ / shares | 0 |
Weighted Average Exercise Price Per Share, Forfeitures | $ / shares | 6.07 |
Weighted Average Exercise Price Per Share, Outstanding at end of period | $ / shares | $ 2.99 |
Aggregate Intrinsic Value, Granted | $ | $ 0 |
Aggregate Intrinsic Value, Outstanding at end of period | $ | $ 1,277 |
Others [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares, Granted | shares | 807,503 |
Weighted Average Exercise Price Per Share, Granted | $ / shares | $ 1.90 |
Stockholders' Equity - Summar54
Stockholders' Equity - Summary of Restricted Stock Activity (Detail) | 6 Months Ended |
Jun. 30, 2017$ / sharesshares | |
Employees [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares, Granted | 807,503 |
Restricted Stock Units (RSUs) [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Restricted Shares, Outstanding at beginning of period | 4,584,297 |
Number of Shares, Granted | 2,180,000 |
Number of Restricted Shares, Vested | (1,357,952) |
Number of Restricted Shares, Forfeitures | (425,676) |
Number of Restricted Shares, Outstanding at end of period | 4,980,669 |
Weighted Average Fair Market Value Per RSU, Outstanding at beginning of period | $ / shares | $ 7.29 |
Weighted Average Fair Market Value Per RSU, Vested | $ / shares | 2.04 |
Weighted Average Fair Market Value Per RSU, Forfeitures | $ / shares | 2.84 |
Weighted Average Fair Market Value Per RSU, Outstanding at end of period | $ / shares | $ 5.04 |
Restricted Stock Units (RSUs) [Member] | Executive Officer [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares, Granted | 1,640,000 |
Weighted Average Fair Market Value Per RSU, Granted | $ / shares | $ 1.80 |
Restricted Stock Units (RSUs) [Member] | Employees [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares, Granted | 540,000 |
Weighted Average Fair Market Value Per RSU, Granted | $ / shares | $ 2.04 |
Stockholders' Equity - Weight55
Stockholders' Equity - Weighted Average for Key Assumptions Used in Determining Fair Value of Warrants Granted (Detail) | 6 Months Ended |
Jun. 30, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Weighted average expected life in years | 6 years |
Dividend yield | 0.00% |
Warrants [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Expected price volatility | 78.39% |
Risk-free interest rate | 1.92% |
Weighted average expected life in years | 6 years |
Dividend yield | 0.00% |
Stockholders' Equity - Summar56
Stockholders' Equity - Summary of Warrant Activity (Detail) - Warrants [Member] - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | |
Jun. 30, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Warrants outstanding at beginning of period, Number of Shares | 84,986 | |
Warrants granted, Number of Shares | 1,701,583 | |
Warrants exercised, Number of Shares | 0 | |
Warrants forfeitures, Number of Shares | 0 | |
Warrants outstanding at end of period, Number of Shares | 1,786,569 | |
Warrants outstanding at beginning of period, Weighted Average Exercise Price Per Share | $ 3.53 | |
Warrants granted, Weighted Average Exercise Price Per Share | 2.38 | |
Warrants exercised, Weighted Average Exercise Price Per Share | 0 | |
Warrants forfeitures, Weighted Average Exercise Price Per Share | 0 | |
Warrants outstanding at end of period, Weighted Average Exercise Price Per Share | $ 2.43 | |
Warrants outstanding, Aggregate Intrinsic Value | $ 0 | $ 0 |
Earnings per Common Share - Rec
Earnings per Common Share - Reconciliation of Numerators and Denominators of Basic and Diluted Loss Per Share Computations (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Basic: | ||||
Net income (loss) | $ (14,879) | $ (16,486) | $ 33,446 | $ (35,219) |
Weighted average common shares outstanding | 55,388,774 | 53,594,979 | 54,949,901 | 53,412,813 |
Basic income (loss) per common share | $ (0.27) | $ (0.31) | $ 0.61 | $ (0.66) |
Effect of dilutive securities: | ||||
Net income (loss) | $ (14,879) | $ (16,486) | $ 33,446 | $ (35,219) |
Weighted average common shares outstanding | 55,388,774 | 53,594,979 | 54,949,901 | 53,412,813 |
Effect of dilutive options and warrants | 886,868 | |||
Diluted weighted average common shares outstanding | 55,388,774 | 53,594,979 | 55,836,769 | 53,412,813 |
Diluted income (loss) per common share | $ (0.27) | $ (0.31) | $ 0.60 | $ (0.66) |
Earnings per Common Share - Add
Earnings per Common Share - Additional information (Detail) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Earnings Per Share [Abstract] | ||||
Securities excluded from computation of diluted earnings per share | 10,037,017 | 10,113,296 | 7,747,726 | 10,490,874 |
Subsequent events - Additional
Subsequent events - Additional Information (Detail) - Subsequent Event [Member] - Purdue Pharma [Member] - Belbuca [Member] - Collaborative Arrangement, Product [Member] | Jul. 12, 2017CAD |
Subsequent Event [Line Items] | |
Upfront and potential milestones payable | CAD 1,500,000 |
Maximum [Member] | |
Subsequent Event [Line Items] | |
Upfront and potential milestones payable | CAD 4,500,000 |