Biodelivery Sciences International (BDSI) 10-Q 10 May 16 2016 Q1 Quarterly report Financial data

Document and Entity Information

Document and Entity Information - shares	3 Months Ended
	Mar. 31, 2016	May. 09, 2016
Document And Entity Information [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Mar. 31, 2016
Document Fiscal Year Focus	2,016
Document Fiscal Period Focus	Q1
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		53,594,979

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Mar. 31, 2016	Dec. 31, 2015
Current assets:
Cash and cash equivalents	$ 69,393	$ 83,560
Accounts receivable, net	2,132	2,488
Inventory	4,821	2,558
Prepaid expenses and other current assets	3,815	3,933
Total current assets	80,161	92,539
Property and equipment, net	4,412	4,262
Goodwill	2,715	2,715
Other intangible assets, net	3,013	3,256
Total assets	90,301	102,772
Current liabilities:
Accounts payable and accrued liabilities	19,063	19,501
Notes payable, current maturities, net	9,707	6,707
Deferred revenue, current	1,640	1,875
Total current liabilities	30,410	28,083
Notes payable, less current maturities, net	19,267	22,168
Deferred revenue, long-term	20,000	20,000
Other long-term liabilities	825	825
Total liabilities	$ 70,502	$ 71,076
Commitments and contingencies (Notes 7 and 11)
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 March 31, 2016 and December 31, 2015	$ 2	$ 2
Common Stock, $.001 par value; 75,000,000 shares authorized; 53,610,470 and 52,730,799 shares issued; 53,594,979 and 52,715,308 shares outstanding at March 31, 2016 and December 31, 2015, respectively	54	53
Additional paid-in capital	281,726	274,891
Treasury stock, at cost, 15,491 shares	(47)	(47)
Accumulated deficit	(261,936)	(243,203)
Total stockholders' equity	19,799	31,696
Total liabilities and stockholders' equity	$ 90,301	$ 102,772

Condensed Consolidated Balance3

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Mar. 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	53,610,470	52,730,799
Common Stock, shares outstanding	53,594,979	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

Condensed Consolidated Statemen

Condensed Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2016	Mar. 31, 2015
Revenues:
Product sales	$ 2,102	$ 677
Product royalty revenues	934	194
Research and development reimbursements	4	775
Contract revenues		11,408
Total Revenues:	3,040	13,054
Cost of sales	2,550	1,124
Expenses:
Research and development	5,377	6,549
Selling, general and administrative	13,055	13,181
Total Expenses:	18,432	19,730
Loss from operations	(17,942)	(7,800)
Interest expense, net	(778)	(420)
Other (expense) income, net	(13)	27
Net loss	$ (18,733)	$ (8,193)
Basic and diluted loss per share:	$ (0.36)	$ (0.16)
Weighted average common stock shares outstanding:	52,230,648	51,908,844

Condensed Consolidated Stateme5

Condensed Consolidated Statement of Stockholders' Equity (Unaudited) - 3 months ended Mar. 31, 2016 - 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, 2015	$ 31,696	$ 53	$ 274,891	$ (47)	$ (243,203)	$ 2
Beginning Balance, shares at Dec. 31, 2015		52,730,799				2,093,155
Stock-based compensation	4,111		4,111
Exercise of stock options	$ 225		225
Exercise of stock options, shares	112,425	112,425
Restricted stock awards	$ 0	$ 0	0	0	0	$ 0
Restricted stock awards, shares		104,025
Common stock issuance upon retirement	2,460	$ 1	2,459
Common stock issuance upon retirement, shares		663,221
Equity financing costs	40		40
Net loss	(18,733)				(18,733)
Ending Balance at Mar. 31, 2016	$ 19,799	$ 54	$ 281,726	$ (47)	$ (261,936)	$ 2
Ending Balance, shares at Mar. 31, 2016		53,610,470				2,093,155

Condensed Consolidated Stateme6

Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2016	Mar. 31, 2015
Operating activities:
Net loss	$ (18,733)	$ (8,193)
Depreciation	86	85
Accretion of debt discount	99	162
Amortization of intangible assets	243	242
Stock-based compensation expense	4,111	3,507
Changes in assets and liabilities:
Accounts receivable	356	109
Inventories	(2,263)	(722)
Prepaid expenses and other assets	118	177
Accounts payable and accrued expenses	(438)	127
Deferred revenue	(235)	(499)
Net cash flows from operating activities	(16,656)	(5,005)
Investing activities:
Purchase of equipment	(236)	(144)
Net cash flows from investing activities	(236)	(144)
Financing activities:
Equity financing costs	40
Proceeds from exercise of stock options	225	131
Proceeds from issuance of common stock	2,460
Payment on note payable		(2,001)
Return of short swing profits		6
Net cash flows from financing activities	2,725	(1,864)
Net change in cash and cash equivalents	(14,167)	(7,013)
Cash and cash equivalents at beginning of year	83,560	70,472
Cash and cash equivalents at end of year	69,393	63,459
Cash paid for interest	$ 679	$ 269

Organization, Basis of Presenta

Organization, Basis of Presentation and Summary of Significant Policies	3 Months Ended
	Mar. 31, 2016
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 leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. The Company is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction. The 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, 2015 has been derived from the Company’s audited consolidated financial statements included in its annual report on Form 10-K for the year ended December 31, 2015. Certain footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) have been condensed or omitted pursuant to the Securities and Exchange Commission (“SEC”) rules and regulations. It is suggested that these condensed consolidated financial statements be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s annual report on Form 10-K for the year ended December 31, 2015. The Company has made certain reclassifications in a footnote table for the year ending December 31, 2015 to conform to the current period presentation. This reclassification had no effect on the measurement of total expenses, loss from operations, or net loss. Operating results for the three month period ended March 31, 2016 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 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 condensed consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates and assumptions. Inventory Inventories are stated at the lower of cost or market value with costs determined on the first-in, first-out method. Inventory consists of raw materials, work in process and finished goods. Raw materials include active pharmaceutical ingredient for a product to be manufactured, work in process includes the bulk inventory of laminate prior to being packaged for sale, and finished goods include pharmaceutical products ready for commercial sale. 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 as of March 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, related supply agreements and product sales. 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. Revenue recognition Net Product Sales Product Sales ® As of March 31, 2016 and December 31, 2015, the Company had $1.6 million and $1.9 million, respectively, 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 March 31, 2016 and December 31, 2015 (Note 4). Product Returns ® 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 ® Prompt Payment Discounts- Gross to Net Accruals ® Once the Company has adequate experience with measuring returns, it will then be able to record sales ex-factory. Deferred Cost of Sales The Company defers its cost of sales in connection with BUNAVAIL ® Cost of Sales For BUNAVAIL ® ® The cost of sales also includes the direct costs attributable to the production of the Company’s BREAKYL ™ Recent accounting pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2014-09, “ Revenue from Contracts with Customers, ” Revenue from Contracts with Customers The FASB’s new leases standard ASU 2016-02 Leases both types of leases (i.e. operating and capital) to be recognized on the balance sheet. The FASB lessee accounting model will continue to account for both types of leases. The capital lease will be accounted for in substantially the same manner as capital leases are accounted for under existing GAAP. The operating lease will be accounted for in a manner similar to operating leases under existing GAAP, except that lessees will recognize a lease liability and a lease asset for all of those leases. The leasing standard will be effective for calendar year-end public companies beginning after December 15, 2018. Public companies will be required to adopt the new leasing standard for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. Early adoption will be permitted for all companies and organizations upon issuance of the standard. For calendar year-end public companies, this means an adoption date of January 1, 2019 and retrospective application to previously issued annual and interim financial statements for 2018 and 2017. Lessees with a large portfolio of leases are likely to see a significant increase in balance sheet assets and liabilities. The Company is currently in the process of evaluating the impact that this new leasing ASU will have on its financial statements. In March 2016, the FASB issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting

Liquidity and Management's Plan

Liquidity and Management's Plans	3 Months Ended
	Mar. 31, 2016
Text Block [Abstract]
Liquidity and Management's Plans	2. Liquidity and management’s plans: At March 31, 2016, the Company had cash and cash equivalents of approximately $69.4 million. The Company used $14.2 million of cash during the three months ended March 31, 2016 and had stockholders’ equity of $19.8 million, versus $31.7 million at December 31, 2015. Based on the Company’s current operational plan and budget, the Company expects that it has sufficient cash to manage its business into approximately into the third quarter of 2017, although this estimation assumes that the Company does not accelerate the development of existing product candidates, 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 likely be required to support the Company’s ongoing commercialization activities for BUNAVAIL ® ®

Inventory

Inventory	3 Months Ended
	Mar. 31, 2016
Inventory Disclosure [Abstract]
Inventory	3. Inventory: The following table represents the components of inventory as of: March 31, December 31, Raw materials & supplies $1,338 $ 443 Work-in-process 2,899 1,216 Finished goods 584 899 Total inventories $4,821 $2,558

Accounts Payable and Accrued Li

Accounts Payable and Accrued Liabilities	3 Months Ended
	Mar. 31, 2016
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: March 31, 2016 December 31, 2015 Accounts payable $ 10,366 $ 10,177 Accrued price adjustments 236 317 Accrued rebates 4,906 4,471 Accrued chargebacks 34 65 Accrued compensation and benefits 1,366 1,917 Accrued royalties 427 431 Accrued clinical trial costs 247 584 Accrued manufacturing costs 308 183 Accrued sales and marketing costs 542 880 Accrued other 631 476 Total accounts payable and accrued expenses $ 19,063 $ 19,501

Property and Equipment

Property and Equipment	3 Months Ended
	Mar. 31, 2016
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: March 31, 2016 December 31, 2015 Machinery & equipment $ 580 $ 580 Computer equipment & software 460 460 Office furniture & equipment 200 200 Leasehold improvements 53 53 Idle equipment 5,219 4,983 Total 6,512 6,276 Less accumulated depreciation (2,100 ) (2,014 ) Total property, plant & equipment, net $ 4,412 $ 4,262 Depreciation expense was approximately $0.09 million for both the three month periods ended March 31, 2016 and 2015.

License and Development Agreeme

License and Development Agreements	3 Months Ended
	Mar. 31, 2016
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 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 (the 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 condensed consolidated financial statements. On March 12, 2012, the Company announced the postponement of the U.S. re-launch of 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 ® ® Recent efforts to extend the Company’s supply agreement with its 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 ™ ™ Pursuant to the Endo Agreement, Endo has obtained all rights necessary to complete the clinical and commercial development of BELBUCA ™ ™ ™ ™ ™ Pursuant to the Endo Agreement, the Company has received (or is expected to receive upon satisfaction of applicable conditions) the following payments (some portion(s) of which will be utilized by the Company to support its development obligations under the Endo Agreement with respect to BELBUCA ™ • $30 million non-refundable upfront license fee (earned in January 2012); • $15 million for enhancement of intellectual property rights (earned in May 2012); • $20 million for full enrollment in two clinical trials ($10 million earned in January 2014 and $10 million earned in June 2014); • $10 million upon FDA acceptance of filing NDA (earned in February 2015); • $50 million upon regulatory approval, earned in October 2015 and received in November 2015, with the revenue recognition treatment for $20 million of such $50 million payment deferred due to the fact that all or a portion of such $20 million is contingently refundable to Endo based on a third party generic introduction in the U.S. during the patent extension period from 2020 to 2027. Should such introduction occur any time during the 2020 to 2027 period, a refund would be due to Endo based on the number of complete calendar months beyond December 31, 2019 where the first generic was sold over the denominator of 84 months multiplied by $20 million. For example, if a generic product were to be introduced in the U.S. in January of 2026, that would mean that 72 of the 84 months of patent exclusivity would have been earned and 12 months would have to be refunded. The calculation would be 12/84, multiplied by $20 million, for a refund of $2.9 million. The method of the refund payment to Endo would be made first by crediting against milestone payments owed to the Company, second by reducing the royalty by 50% until the $2.9 million is paid back, and third by the Company making a payment in the amount due to Endo. Otherwise, the $20 million will be earned as revenue each month over the patent extension period from 2020 to 2027; • up to an aggregate of $55 million based on the achievement of four separate post-approval sales thresholds; and • sales-based royalties in a particular percentage range on U.S. sales of 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 $30 million license fee was allocated to each of the three deliverables based upon their relative selling prices using best estimates. The analysis of the best estimate of the selling price of the deliverables was based on the income approach, the Company’s negotiations with Endo and other factors, and was further based on management’s estimates and assumptions which included consideration of how a market participant would use the license, estimated market opportunity and market share, the Company’s estimates of what contract research organizations would charge for clinical development services, the costs of clinical trial materials and other factors. Also considered were entity specific assumptions regarding the results of clinical trials, the likelihood of FDA approval of the subject product and the likelihood of commercialization based in part on the Company’s prior agreements with the BEMA ® Based on this analysis, $15.6 million of the up-front license fee was allocated to the license and $14.4 million to clinical development services (which is inclusive of the cost of CTM). Although the intellectual property component was considered a separate deliverable, no distinct amount of the up-front payment was assigned to this deliverable because the Company determined the deliverable to be perfunctory. The amount allocated to the license was recognized as revenue in fiscal year 2012. The portion of the upfront license fee allocated to the clinical development services deliverable of $14.4 million is being recognized as those services are performed. The Company estimated that such clinical development services would extend into the first half of 2015. Such services were completed during the three months ended March 31, 2015 and resulted in the recognition of $0.4 million in the accompanying condensed consolidated statements of operations. There was no remaining deferred revenue related to the upfront license fee recorded during the three months ended March 31, 2016. The term of the Endo Agreement shall last, on a country-by-country basis, until the later of: (i) 10 years from the date of the first commercial sale of BELBUCA ™ ™ The remaining milestone payments are expected to be recognized as revenue as they are achieved, except that $20 Million of the $50 million regulatory approval milestone received in November for the Patent Life Extension is contingently refundable from 2020 to 2027 and revenue related to such contingently refundable milestone has been deferred for future recognition. The $20 million will be earned over the extended 84 month patent period as it is contingently refundable pending a generic product commercially launched in the U.S. during the patent extension period. Sales threshold payments and sales-based royalties will be recognized as they accrue under the terms of the Endo Agreement. The Company is reimbursed by Endo for certain contractor costs when these costs go beyond set thresholds as outlined in the Endo Agreement. Endo reimburses the Company for this spending at cost and the Company receives no mark-up or profit. The gross amount of these reimbursed research and development costs are reported as research and development reimbursement revenue in the accompanying condensed consolidated statements of operations. The Company acts as a principal, has discretion to choose suppliers, bears credit risk and may perform part of the services required in the transactions. Therefore, these reimbursements are treated as revenue to the Company. The actual expenses creating the reimbursements are reflected as research and development expense. Beginning in March 2014, total reimbursable contractor costs exceeded a set threshold, at which point all such expenses are to be borne at a rate of 50% by Endo and 50% by the Company. Endo has continued to reimburse the Company for 100% of such costs, with 50% thereof to be taken by Endo as a credit against potential future milestones associated with achievement of certain regulatory events. During the three months ended March 31, 2016 and 2015, the Company recognized $0.004 million and $0.8 million, respectively, of reimbursable expenses related to the Endo Agreement, which is recorded as research and development reimbursement revenue on the accompanying condensed consolidated statement of operations. On December 23, 2014, the Company and Endo announced the submission of a NDA for BELBUCA ™ ™ ™ On February 22, 2016, the Company and Endo announced the commercial availability of BELBUCA ™ ™

License Obligations

License Obligations	3 Months Ended
	Mar. 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 research and development to develop, manufacture, market, and sell gel products containing clonidine (or a derivative thereof) for the treatment of painful diabetic neuropathy (“PDN”) and other indications (the “Arcion Products”). Pursuant to the Arcion Agreement, the Company is responsible for using commercially reasonable efforts to develop and commercialize Arcion Products, including the use of such efforts to conduct certain clinical trials within certain time frames. The Company is required to make the following payments to Arcion: • $2.5 million upon filing and acceptance by the FDA of an NDA with respect to an Arcion Product, which will be payable, at the Company’s option, in cash or unregistered shares of Common Stock (with such shares being subject to a nine month lock-up and certain limitations on sale thereafter); and • up to a potential $60 million in cash payments upon achieving certain pre-determined sales thresholds in the U.S., none of which occur prior to achieving at least $200 million in U.S. net sales. In addition, the Company shall pay Arcion $35 million in cash on initial FDA approval of an Arcion Product, unless: (i) the Company does not receive at least $70 million in FDA approval-related milestone payments from its US sublicensees (if any sublicenses are involved) with respect to the Arcion Product, in which case the Company shall pay Arcion a prorated amount between $17.5 million and $35 million based on the total amount of such milestone payments received by the Company and its affiliates from its sublicenses (if any sublicenses are involved); or (ii) the FDA requires or recommends the performance of a capsaicin challenge test (to see if C-fiber function is present in the skin by determining if subjects experience pain, and to determine pain intensity if present) as a precondition or precursor to the prescribing of the Arcion Product (as a condition of approval, a labeling requirement, or otherwise), in which case such milestone shall be reduced to $17.5 million, but the first and second sales threshold payments (as part of the $60 million in cash payments ) described above shall each be increased by $8 million. All milestone payments due to Arcion under the Arcion Agreement are payable only once each. In addition to the milestones set forth above, the Company will pay royalties to Arcion based upon sales of Arcion Products by the Company, its affiliate and sub-licensees (if any), all as defined in the Arcion Agreement. In addition, in the event the amount due upon FDA approval of the Arcion Product in the U.S. is less than $35 million for any reason other than an FDA requirement or recommendation of a capsaicin challenge test, as described above, the Company shall pay Arcion a portion of any milestone payments received by the Company and its affiliates from their sublicensees on the basis of any events occurring in the U.S. following FDA approval but prior to (and including) first commercial sale of an Arcion Product in the U.S., and certain of the payments to Arcion referred to above shall also be subject to upward adjustment (with such upward adjustments payable in the form of cash or unregistered shares of the Company’s Common Stock, as elected solely by the Company), until such time as the sum of all such additional payments and upward adjustments (including the value of any issuances of stock, if elected by the Company) and the initial amount paid on the initial FDA approval totals $35 million. The term of the Arcion Agreement continues, on a country-by-country and product-by-product basis, until the earlier of (i) the expiration of the royalty term for a particular Arcion Product in a particular country or (ii) the effective date of termination by either party pursuant to customary termination provisions. The royalty term for any given country is the later of (i) the first date there are no valid claims against any Arcion patent, (ii) expiration of patent exclusivity or (iii) tenth anniversary of the first commercial sale. 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. The final study subject is expected to complete treatment by the end of 2016. 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. 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 such 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 the 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 payment in conjunction with certain future regulatory filings and approvals and royalties on net sales of the Evonik Product. 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 third party costs and any reasonable, documented wind-down costs reasonably incurred by Evonik in connection with the Evonik Project. Should the Company terminate for reasons other than for a material, uncured breach by Evonik or Evonik’s bankruptcy, Evonik shall have the right to use any and all data and intellectual property generated under the Evonik Project for any purpose.

Other License Agreements and Ac

Other License Agreements and Acquired Product Rights	3 Months Ended
	Mar. 31, 2016
Goodwill and Intangible Assets Disclosure [Abstract]
Other License Agreements and Acquired Product Rights	8. 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 ® ® On July 29, 2013, the Company announced the regulatory approval of BEMA ® ™ On February 4, 2016, the Company received a payment of $0.2 million from TTY, which related to royalties based on product purchased in Taiwan by TTY of PAINKYL ™

Note Payable (MidCap Loan)

Note Payable (MidCap Loan)	3 Months Ended
	Mar. 31, 2016
Debt Disclosure [Abstract]
Note Payable (MidCap Loan)	9. 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 Credit Agreement is 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 Loan has 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 March 31, 2016), with straight line amortization of principal payments commencing on June 1, 2016, 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. Under the Credit Agreement, the Company is subject to affirmative covenants which are customary for financings of this type, including, but not limited to, the obligations of the Company to: (i) maintain good standing and governmental authorizations, (ii) provide certain information and notices to MidCap, (iii) deliver quarterly and annual financial statements to MidCap, (iv) maintain insurance, property and books and records, (v) discharge all taxes, (vi) protect their intellectual property and (vii) generally protect the collateral granted to MidCap. The Company is also subject to negative covenants customary for financings of this type, including, but not limited to, that they may not: (i) enter into a merger or consolidation or certain change of control events without complying with the terms of the Credit Agreement, (ii) incur liens on the collateral, (iii) incur additional indebtedness, (iv) dispose of any property, (v) amend material agreements or organizational documents, (vi) change their business, jurisdictions of organization or their organizational structures or types, (vii) declare or pay dividends (other than dividends payable solely in Common Stock), (viii) make certain investments or acquisitions except under certain circumstances as set forth in the Credit Agreement, or (ix) enter into certain transactions with affiliates, in each case subject to certain exceptions provided for in the Credit Agreement. Notwithstanding the foregoing, the Credit Agreement amends certain negative covenants contained in the Prior Agreement such that (i) licensing and acquisitions are added as permitted business activities of the Company and (ii) the Company is no longer required to obtain the prior written consent of MidCap for any in-licensing, product or entity acquisitions by the Company by way of merger or consolidation, so long as no event of default has occurred and certain financial metrics are adhered to. The Credit Agreement provides for several events of default under the Loan. Upon the occurrence of any event of default, the Company’s obligations under the Credit Agreement will bear interest at a rate equal to the lesser of: (i) 4% above the rate of interest applicable to such obligations immediately prior to the occurrence of the event of default and (ii) the maximum rate allowable under law. 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. The balance of the Loan as of March 31, 2016 is $30.0 million, and is recorded in the accompanying condensed consolidated balance sheet, net of unamortized discount of $1.0 million.

Stockholders' Equity

Stockholders' Equity	3 Months Ended
	Mar. 31, 2016
Equity [Abstract]
Stockholders' Equity	10. Stockholders’ Equity: Stock-based compensation During the three months ended March 31, 2016, a total of 190,513 options to purchase Common Stock, with an aggregate fair market value of approximately $0.8 million, were granted to Company employees and contractors. 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, Stock-based compensation expense March 31, March 31, 2015 Research and Development $ 1,128 $ 852 Selling, General and Administrative $ 2,983 $ 2,655 The fair value of each option award is estimated on the grant date using the Black-Scholes valuation model that uses assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate. Expected volatilities are based on implied volatilities from historical volatility of the Common Stock, and other factors estimated over the expected term of the options. The expected term of options granted is derived using the “simplified method” which computes expected term as the average of the sum of the vesting term plus contract term. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for the period of the expected term. The weighted average for key assumptions used in determining the fair value of options granted during the three months ended March 31, 2016 follows: Expected price volatility 72.15% -82.71% Risk-free interest rate 1.22% - 1.70% Weighted average expected life in years 6 years Dividend yield — Option activity during the three months ended March 31, 2016 was as follows: Number of Shares Weighted Average Exercise Price Per Share Aggregate Intrinsic Value Outstanding at January 1, 2016 3,397,529 $ 5.42 Granted 190,513 4.42 Exercised (112,425 ) 2.00 Forfeitures (36,814 ) 11.98 Outstanding at March 31, 2016 3,438,803 $ 5.42 $ 874 As of March 31, 2016, options exercisable totaled 2,507,446. There was approximately $21.9 million of unrecognized compensation cost related to non-vested share-based compensation awards, including options and restricted stock units (“RSUs”) granted. These costs will be expensed through 2019. Earnings Per Share During the three months ended March 31, 2016 and 2015, outstanding stock options, RSUs, warrants and convertible preferred stock of 10,113,296 and 9,459,110, respectively, were not included in the computation of diluted earnings per share, because to do so would have had an antidilutive effect. Restricted Stock Units During the three months ended March 31, 2016, 943,000 restricted stock units (“RSUs”) were granted to members of the Company’s executive officers and employees, with a fair market value of approximately $3.6 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. Restricted stock activity during the three months ended March 31, 2016 was as follows: Number of Weighted Outstanding at January 1, 2016 4,298,154 $ 10.23 Granted: Executive officers 913,000 3.80 Directors — — Employees 30,000 3.60 Vested (104,025) 3.89 Forfeitures (555,791) 12.56 Outstanding at March 31, 2016 4,581,338 $ 8.34 Common Stock 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 issuance of shares of Common Stock based upon a net present valuation of the cancelled RSUs as set forth in the Retirement Agreement (which resulted in an issuance of 513,221 shares of Common Stock which were issued in January 2016). In early 2016, following its review of the Company’s corporate performance for 2015, the Compensation Committee approved equity awards 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, which shares were issued in March 2016.

Commitments and Contingencies

Commitments and Contingencies	3 Months Ended
	Mar. 31, 2016
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	11. 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 ® ® In November 2011, the United States Patent and Trademark Office (“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. 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 Patent Trial and Appeal Board (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 ® ® 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 was dismissed. Thus, the district court’s grant of the Summary Judgement of Intervening Rights will stand. The possibility exists, however, that MonoSol could file another suit alleging infringement of the ‘292 and ’891 patents. The Company believes ONSOLIS ® ® ® Litigation Related To BUNAVAIL ® On October 29, 2013, Reckitt Benckiser, Inc. RB Pharmaceuticals Limited, and MonoSol (collectively, the “RB Plaintiffs”) filed an action against the Company relating to the Company’s BUNAVAIL ® ® ® On September 20, 2014, based upon the Company’s position and belief that its BUNAVAIL ® ® 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 the Company’s commercial partner) relating to its 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 the Company filed a request for rehearing for the non-instituted IPR. The final decisions finding all claims patentable were issued in March 2016 and the Company filed a Request for Reconsideration in the USPTO in April 2016. While the claims were upheld in the opinion, BUNAVAIL ® 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 USPTO rehear the IPR. The Company will continue to vigorously defend its ‘019 patent. The Company expects the USPTO to issue a decision in the second half of 2016. Actavis On February 8, 2016, the Company received a purported 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 believes that Actavis’ claims of invalidity of the Patents are wholly without merit and, as the Company has done in the past, intends to vigorously defend its intellectual property. The Company is highly confident that the Patents are valid, as evidenced in part by the fact that 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. Although there is a pending request for rehearing of the final IPR decision regarding the ‘019 Patent pending at the USPTO, the Company believes the USPTO’s decision will be upheld. Under the Food Drug and Cosmetic Act, as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, as amended (the “Hatch-Waxman Amendments”), after receipt of a valid Paragraph IV notice, the Company may, and in this case plans to, bring a patent infringement suit in federal district court against Actavis within 45 days from the date of receipt of the certification notice. On March 18, 2016 the Company filed a complaint in Delaware against Actavis, thus the Company is entitled to receive a 30 month stay on FDA’s ability to give final approval to any proposed products that reference BUNAVAIL ® ® ® ® ®

Subsequent Events

Subsequent Events	3 Months Ended
	Mar. 31, 2016
Subsequent Events [Abstract]
Subsequent Events	12. Subsequent events. 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.

Organization, Basis of Presen19

Organization, Basis of Presentation and Summary of Significant Policies (Policies)	3 Months Ended
	Mar. 31, 2016
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 leveraging its novel and proprietary patented drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, new applications of proven therapeutics. The Company is focusing on developing products to meet unmet patient needs in the areas of pain management and addiction. The 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, 2015 has been derived from the Company’s audited consolidated financial statements included in its annual report on Form 10-K for the year ended December 31, 2015. Certain footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) have been condensed or omitted pursuant to the Securities and Exchange Commission (“SEC”) rules and regulations. It is suggested that these condensed consolidated financial statements be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s annual report on Form 10-K for the year ended December 31, 2015. The Company has made certain reclassifications in a footnote table for the year ending December 31, 2015 to conform to the current period presentation. This reclassification had no effect on the measurement of total expenses, loss from operations, or net loss. Operating results for the three month period ended March 31, 2016 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 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 condensed consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates and assumptions.
Inventory	Inventory Inventories are stated at the lower of cost or market value with costs determined on the first-in, first-out method. Inventory consists of raw materials, work in process and finished goods. Raw materials include active pharmaceutical ingredient for a product to be manufactured, work in process includes the bulk inventory of laminate prior to being packaged for sale, and finished goods include pharmaceutical products ready for commercial sale. 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 as of March 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, related supply agreements and product sales. 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.
Revenue recognition	Revenue recognition Net Product Sales Product Sales ® As of March 31, 2016 and December 31, 2015, the Company had $1.6 million and $1.9 million, respectively, 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 March 31, 2016 and December 31, 2015 (Note 4). Product Returns ® 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 ® Prompt Payment Discounts- Gross to Net Accruals ® Once the Company has adequate experience with measuring returns, it will then be able to record sales ex-factory.
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 For BUNAVAIL ® ® The cost of sales also includes the direct costs attributable to the production of the Company’s BREAKYL ™
Recent accounting pronouncements	Recent accounting pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2014-09, “ Revenue from Contracts with Customers, ” Revenue from Contracts with Customers The FASB’s new leases standard ASU 2016-02 Leases both types of leases (i.e. operating and capital) to be recognized on the balance sheet. The FASB lessee accounting model will continue to account for both types of leases. The capital lease will be accounted for in substantially the same manner as capital leases are accounted for under existing GAAP. The operating lease will be accounted for in a manner similar to operating leases under existing GAAP, except that lessees will recognize a lease liability and a lease asset for all of those leases. The leasing standard will be effective for calendar year-end public companies beginning after December 15, 2018. Public companies will be required to adopt the new leasing standard for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. Early adoption will be permitted for all companies and organizations upon issuance of the standard. For calendar year-end public companies, this means an adoption date of January 1, 2019 and retrospective application to previously issued annual and interim financial statements for 2018 and 2017. Lessees with a large portfolio of leases are likely to see a significant increase in balance sheet assets and liabilities. The Company is currently in the process of evaluating the impact that this new leasing ASU will have on its financial statements. In March 2016, the FASB issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting

Inventory (Tables)

Inventory (Tables)	3 Months Ended
	Mar. 31, 2016
Inventory Disclosure [Abstract]
Summary of Inventories	The following table represents the components of inventory as of: March 31, December 31, Raw materials & supplies $1,338 $ 443 Work-in-process 2,899 1,216 Finished goods 584 899 Total inventories $4,821 $2,558

Accounts Payable and Accrued 21

Accounts Payable and Accrued Liabilities (Tables)	3 Months Ended
	Mar. 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: March 31, 2016 December 31, 2015 Accounts payable $ 10,366 $ 10,177 Accrued price adjustments 236 317 Accrued rebates 4,906 4,471 Accrued chargebacks 34 65 Accrued compensation and benefits 1,366 1,917 Accrued royalties 427 431 Accrued clinical trial costs 247 584 Accrued manufacturing costs 308 183 Accrued sales and marketing costs 542 880 Accrued other 631 476 Total accounts payable and accrued expenses $ 19,063 $ 19,501

Property and Equipment (Tables)

Property and Equipment (Tables)	3 Months Ended
	Mar. 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: March 31, 2016 December 31, 2015 Machinery & equipment $ 580 $ 580 Computer equipment & software 460 460 Office furniture & equipment 200 200 Leasehold improvements 53 53 Idle equipment 5,219 4,983 Total 6,512 6,276 Less accumulated depreciation (2,100 ) (2,014 ) Total property, plant & equipment, net $ 4,412 $ 4,262

Stockholders' Equity (Tables)

Stockholders' Equity (Tables)	3 Months Ended
	Mar. 31, 2016
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, Stock-based compensation expense March 31, March 31, 2015 Research and Development $ 1,128 $ 852 Selling, General and Administrative $ 2,983 $ 2,655
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 three months ended March 31, 2016 follows: Expected price volatility 72.15% -82.71% Risk-free interest rate 1.22% - 1.70% Weighted average expected life in years 6 years Dividend yield —
Summary of Stock Option Activity	Option activity during the three months ended March 31, 2016 was as follows: Number of Shares Weighted Average Exercise Price Per Share Aggregate Intrinsic Value Outstanding at January 1, 2016 3,397,529 $ 5.42 Granted 190,513 4.42 Exercised (112,425 ) 2.00 Forfeitures (36,814 ) 11.98 Outstanding at March 31, 2016 3,438,803 $ 5.42 $ 874
Summary of Restricted Stock Activity	Restricted stock activity during the three months ended March 31, 2016 was as follows: Number of Weighted Outstanding at January 1, 2016 4,298,154 $ 10.23 Granted: Executive officers 913,000 3.80 Directors — — Employees 30,000 3.60 Vested (104,025) 3.89 Forfeitures (555,791) 12.56 Outstanding at March 31, 2016 4,581,338 $ 8.34

Organization, Basis of Presen24

Organization, Basis of Presentation and Summary of Significant Policies - Additional Information (Detail)	3 Months Ended
	Mar. 31, 2016USD ($)Customer$ / shares	Dec. 31, 2015USD ($)$ / shares
Basis Of Presentation [Line Items]
Common Stock, par value | $ / shares	$ 0.001	$ 0.001
Inventory allowances recorded	$ 0
Deferred revenue related to sales	$ 1,600,000	$ 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	90.00%
BUNAVAIL [Member]
Basis Of Presentation [Line Items]
Deferred cost of sales	$ 1,600,000	$ 1,700,000
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 Pl25

Liquidity and Management's Plans - Additional Information (Detail) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2016	Mar. 31, 2015	Dec. 31, 2015	Dec. 31, 2014
Liquidity And Managements Plans [Abstract]
Cash and cash equivalents	$ 69,393	$ 63,459	$ 83,560	$ 70,472
Cash used	(14,167)	$ (7,013)
Stockholders' equity	$ 19,799		$ 31,696

Inventory - Summary of Inventor

Inventory - Summary of Inventories (Detail) - USD ($) $ in Thousands	Mar. 31, 2016	Dec. 31, 2015
Inventory Disclosure [Abstract]
Raw materials & supplies	$ 1,338	$ 443
Work-in-process	2,899	1,216
Finished goods	584	899
Total inventories	$ 4,821	$ 2,558

Accounts Payable and Accrued 27

Accounts Payable and Accrued Liabilities - Summary of Components of Accounts Payable and Accrued Liabilities (Detail) - USD ($) $ in Thousands	Mar. 31, 2016	Dec. 31, 2015
Payables and Accruals [Abstract]
Accounts payable	$ 10,366	$ 10,177
Accrued price adjustments	236	317
Accrued rebates	4,906	4,471
Accrued chargebacks	34	65
Accrued compensation and benefits	1,366	1,917
Accrued royalties	427	431
Accrued clinical trial costs	247	584
Accrued manufacturing costs	308	183
Accrued sales and marketing costs	542	880
Accrued other	631	476
Total accounts payable and accrued expenses	$ 19,063	$ 19,501

Property and Equipment - Summar

Property and Equipment - Summarized Category of Fixed Assets (Detail) - USD ($) $ in Thousands	Mar. 31, 2016	Dec. 31, 2015
Property, Plant and Equipment [Line Items]
Property, plant & equipment, gross	$ 6,512	$ 6,276
Less accumulated depreciation	(2,100)	(2,014)
Total property, plant & equipment, net	4,412	4,262
Machinery and Equipment [Member]
Property, Plant and Equipment [Line Items]
Property, plant & equipment, gross	580	580
Computer Equipment and Software [Member]
Property, Plant and Equipment [Line Items]
Property, plant & equipment, gross	460	460
Office Furniture and Equipment [Member]
Property, Plant and Equipment [Line Items]
Property, plant & equipment, gross	200	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	$ 5,219	$ 4,983

Property and Equipment - Additi

Property and Equipment - Additional Information (Detail) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2016	Mar. 31, 2015
Property, Plant and Equipment [Abstract]
Depreciation	$ 86	$ 85

License and Development Agree30

License and Development Agreements - Meda License, Development and Supply Agreements - Additional Information (Detail) - USD ($)	1 Months Ended		3 Months Ended
	Nov. 30, 2015	Oct. 31, 2009	Mar. 31, 2016	Mar. 31, 2015
Revenue Recognition, Milestone Method [Line Items]
Patent expiration year			2,020
Aggregate milestones and services revenue recognized	$ 20,000,000
Contract revenues				$ 11,408,000
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 Agree31

License and Development Agreements - Endo License and Development Agreement - Additional Information (Detail)	Oct. 26, 2015USD ($)	Nov. 30, 2015USD ($)	Oct. 31, 2015USD ($)	Feb. 28, 2015USD ($)	May. 31, 2012USD ($)	Mar. 31, 2016USD ($)MilestoneClinical_Trials	Mar. 31, 2015USD ($)	Dec. 31, 2015USD ($)	Jun. 30, 2014USD ($)	Jan. 31, 2014USD ($)	Jan. 31, 2012USD ($)
Revenue Recognition, Milestone Method [Line Items]
Non-refundable payment received											$ 30,000,000
Potential milestone payments on intellectual property rights					$ 15,000,000
Potential payments upon filing and acceptance				$ 10,000,000
Potential milestone payment receivable upon regulatory approval	$ 50,000,000		$ 50,000,000
Milestone payment upon regulatory approval deferred for future revenue recognition		$ 20,000,000
Patent extension starting period						2,020
Patent extension ending period						2,027
Deferred revenue refund payment						$ 2,900,000
Royalty payment description						$50 million upon regulatory approval, earned in October 2015 and received in November 2015, with the revenue recognition treatment for $20 million of such $50 million payment deferred due to the fact that all or a portion of such $20 million is contingently refundable to Endo based on a third party generic introduction in the U.S. during the patent extension period from 2020 to 2027. Should such introduction occur any time during the 2020 to 2027 period, a refund would be due to Endo based on the number of complete calendar months beyond December 31, 2019 where the first generic was sold over the denominator of 84 months multiplied by $20 million. For example, if a generic product were to be introduced in the U.S. in January of 2026, that would mean that 72 of the 84 months of patent exclusivity would have been earned and 12 months would have to be refunded. The calculation would be 12/84, multiplied by $20 million, for a refund of $2.9 million. The method of the refund payment to Endo would be made first by crediting against milestone payments owed to the Company, second by reducing the royalty by 50% until the $2.9 million is paid back, and third by the Company making a payment in the amount due to Endo. Otherwise, the $20 million will be earned as revenue each month over the patent extension period from 2020 to 2027;
Royalty reduction percentage						50.00%
Payment receivable on achievement of potential sales milestones						$ 55,000,000
Number of potential sales milestones | Milestone						4
Recognized up-front payment allocated to the license						$ 15,600,000
Recognized up-front payment to clinical trial material and development services						$ 14,400,000
Contract revenues							$ 11,408,000
Term of Endo Agreement						10 years
Total rate of reimbursable contractor costs borne						50.00%
Deferred revenue from research and development activities						$ 4,000	775,000
Deferred revenue recognized during the period								$ 6,000,000
Endo Agreement [Member]
Revenue Recognition, Milestone Method [Line Items]
Contract revenues						400,000
Deferred revenue related to upfront license fee						$ 0
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						$ 4,000	$ 800,000
Clinical Trials Full Enrollment [Member]
Revenue Recognition, Milestone Method [Line Items]
Potential milestone payment received, clinical development						$ 20,000,000
Number of clinical trials | Clinical_Trials						2
Clinical Trials One [Member]
Revenue Recognition, Milestone Method [Line Items]
Potential milestone payment received, clinical development										$ 10,000,000
Clinical Trials Two [Member]
Revenue Recognition, Milestone Method [Line Items]
Potential milestone payment received, clinical development									$ 10,000,000

License Obligations - Arcion Li

License Obligations - Arcion License Agreement - Additional Information (Detail) - USD ($)	1 Months Ended	3 Months Ended
	Feb. 28, 2015	Mar. 31, 2016
Research and Development Arrangement, Contract to Perform for Others [Line Items]
Potential payments upon filing and acceptance	$ 10,000,000
Increase in milestone payments		$ 8,000,000
U.S. [Member]
Research and Development Arrangement, Contract to Perform for Others [Line Items]
Potential Payments upon achieving certain pre-determined sales thresholds in the U.S		60,000,000
U.S. [Member] | Minimum [Member]
Research and Development Arrangement, Contract to Perform for Others [Line Items]
Milestone Sales		200,000,000
Milestone payments receivable from sublicenses		70,000,000
Arcion Agreement [Member]
Research and Development Arrangement, Contract to Perform for Others [Line Items]
Potential payments upon filing and acceptance		$ 2,500,000
Royalty term description		The royalty term for any given country is the later of (i) the first date there are no valid claims against any Arcion patent, (ii) expiration of patent exclusivity or (iii) tenth anniversary of the first commercial sale.
Arcion Agreement [Member] | Minimum [Member]
Research and Development Arrangement, Contract to Perform for Others [Line Items]
Potential milestone payments upon FDA approval		$ 17,500,000
Arcion Agreement [Member] | Maximum [Member]
Research and Development Arrangement, Contract to Perform for Others [Line Items]
Potential milestone payments upon FDA approval		$ 35,000,000

License Obligations - Evonik De

License Obligations - Evonik Definitive Development and Exclusive License Option Agreement - Additional Information (Detail)	3 Months Ended
	Mar. 31, 2016Agreement
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 34

Other License Agreements and Acquired Product Rights - Additional Information (Detail) - TTY License and Supply Agreement [Member] - USD ($) $ in Millions	Feb. 04, 2016	Oct. 07, 2010	Mar. 31, 2016	Sep. 30, 2013
Other License Agreements And Acquired Product Rights [Line Items]
Upfront payment		$ 0.3
Milestone payments		$ 1.3
Term of the agreement			15 years
Milestone payment received	$ 0.2			$ 0.3

Note Payable (MidCap Loan) - Ad

Note Payable (MidCap Loan) - Additional Information (Detail) - Secured Loan Facility [Member] - USD ($) $ in Millions	May. 29, 2015	Mar. 31, 2016
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%
Mid Cap [Member]
Debt Instrument [Line Items]
Secured loan facility	30
Net proceeds in aggregate amount	$ 20.1
Rate of interest applicable to obligations		4.00%
Loan, gross		$ 30
Unamortized discount		$ 1

Stockholders' Equity - Addition

Stockholders' Equity - Additional information (Detail) - USD ($) $ in Millions	Dec. 16, 2015	Mar. 31, 2016	Mar. 31, 2015
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Term of options granted period		10 years
Vesting period of shares		3 years
Unrecognized compensation cost related to non-vested share-based compensation awards granted		$ 21.9
Unrecognized compensation cost related to non-vested share-based compensation awards granted year		2,019
Stock option exercisable		2,507,446
Securities excluded from computation of diluted earnings per share		10,113,296	9,459,110
Vesting period of options		3 years
Restricted Stock Units (RSUs) [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of equity instruments awarded in period		943,000
Fair market value of RSUs granted		$ 3.6
Directors and Employees [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of equity instruments awarded in period		190,513
Fair market value of shares granted		$ 0.8
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

Stockholders' Equity - Summary

Stockholders' Equity - Summary of Allocated Stock-based Compensation Expense (Detail) - USD ($) $ in Millions	3 Months Ended
	Mar. 31, 2016	Mar. 31, 2015
Research and Development [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Stock-based compensation expense	$ 1,128	$ 852
Selling, General and Administrative [Member]
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items]
Stock-based compensation expense	$ 2,983	$ 2,655

Stockholders' Equity - Weighted

Stockholders' Equity - Weighted Average for Key Assumptions Used in Determining Fair Value of Options Granted (Detail)	3 Months Ended
	Mar. 31, 2016
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	72.15%
Risk-free interest rate	1.22%
Maximum [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Expected price volatility	82.71%
Risk-free interest rate	1.70%

Stockholders' Equity - Summar39

Stockholders' Equity - Summary of Stock Option Activity (Detail) $ / shares in Units, $ in Thousands	3 Months Ended
	Mar. 31, 2016USD ($)$ / sharesshares
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
Number of Shares, Outstanding at beginning of period | shares	3,397,529
Number of Shares, Granted | shares	190,513
Number of Shares, Exercised | shares	(112,425)
Number of Shares, Forfeitures | shares	(36,814)
Number of Shares, Outstanding at end of period | shares	3,438,803
Weighted Average Exercise Price Per Share, Outstanding at beginning of period | $ / shares	$ 5.42
Weighted Average Exercise Price Per Share, Granted | $ / shares	4.42
Weighted average Exercise Price Per Share, Exercised | $ / shares	2
Weighted Average Exercise Price Per Share, Forfeitures | $ / shares	11.98
Weighted Average Exercise Price Per Share, Outstanding at end of period | $ / shares	$ 5.42
Aggregate Intrinsic Value, Outstanding at end of period | $	$ 874

Stockholders' Equity - Summar40

Stockholders' Equity - Summary of Restricted Stock Activity (Detail) - Restricted Stock Units (RSUs) [Member]	3 Months Ended
	Mar. 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	943,000
Number of Restricted Shares, Vested	(104,025)
Number of Restricted Shares, Forfeitures	(555,791)
Number of Restricted Shares, Outstanding at end of period	4,581,338
Weighted Average Fair Market Value Per RSU, Outstanding at beginning of period | $ / shares	$ 10.23
Weighted Average Fair Market Value Per RSU, Vested | $ / shares	3.89
Weighted Average Fair Market Value Per RSU, Forfeitures | $ / shares	12.56
Weighted Average Fair Market Value Per RSU, Outstanding at end of period | $ / shares	$ 8.34
Executive Officer [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of Shares, Granted	913,000
Weighted Average Fair Market Value Per RSU, Granted | $ / shares	$ 3.80
Employees [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Number of Shares, Granted	30,000
Weighted Average Fair Market Value Per RSU, Granted | $ / shares	$ 3.60

Subsequent Events - Additional

Subsequent Events - Additional Information (Detail) - Subsequent Event [Member] - Mid Cap [Member]	May. 05, 2016$ / sharesshares
Subsequent Event [Line Items]
Number of warrants to purchase common stock | shares	84,986
Exercise price of warrants to purchase common stock | $ / shares	$ 3.53