Nature of Business and Summary of Significant Accounting Policies | 1. Nature of business and summary of significant accounting policies: Organization BioDelivery Sciences International, Inc. and subsidiaries (the “Company”) was incorporated in the State of Indiana on January 6, 1997 and reincorporated as a Delaware corporation in 2002. The Company’s subsidiaries are Arius Pharmaceuticals, Inc., a Delaware corporation (“Arius One”) and Arius Two, Inc., a Delaware corporation (“Arius Two”), each of which are wholly-owned, and its majority-owned subsidiary, Bioral Nutrient Delivery, LLC, a Delaware limited liability company (“BND”). The Company is a specialty pharmaceutical company with a focus in the areas of pain management and addiction medicine. The Company is utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA ® As used herein, the Company’s common stock, par value $.001 per share, is referred to as the “Common Stock”. Principles of consolidation The consolidated financial statements include the accounts of the Company, Arius One, Arius Two and BND. For each period presented BND has been an inactive subsidiary. All significant inter-company balances and transactions have been eliminated. Significant accounting policies: Use of estimates in financial statements The preparation of the accompanying consolidated financial statements requires management to make 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 bonuses, stock-based compensation, determination of fair values of assets and liabilities relating to 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 ® ® ® ® Reclassification Certain amounts were reclassified between Accounts Receivable and Accounts Payable and Accrued Expenses for the year ended December 31, 2016 Consolidated Balance Sheet and in the Consolidated Statement of Cash Flows for the years ended December 31, 2016 and 2015 to conform to current year presentation to reflect the right of offset and practice of settling certain liabilities with our wholesale customers. Certain amounts were also reclassified between Accounts Payable and Accrued Liabilities in note 3, for the year ended December 31, 2016 to conform to current year presentation. The Company also reclassified certain amounts between Machinery & Equipment and Idle Equipment in note 4, for the year ended December 31, 2016. These reclassifications had no effect on the previously reported net cash flows from operations, activities or net losses. Certain risks, concentrations and uncertainties The Company relies on certain materials used in its development and third-party manufacturing processes, most of which are procured from three contract manufacturers and two active pharmaceutical ingredient (“API”) suppliers for BELBUCA ® ® ® ® In addition, the Company utilizes only two contract manufacturers to create the BELBUCA ® ® ® ® Key components used in the manufacture of ONSOLIS ® The Company sells its BELBUCA ® ® December 31, Customers 2017 2016 Customer A 47 % 36 % Customer B 22 % 28 % Customer C 26 % 28 % Total 95 % 92 % These three customers accounted for 92%, 91% and 90% of total annual sales during the years ended December 31, 2017, 2016 and 2015 respectively. Cash The Company places cash on deposit with financial institutions in the United States. The Federal Deposit Insurance Corporation covers $0.25 million for substantially all depository accounts. As of December 31, 2017, the Company had approximately $21.2 million, which exceeded these insured limits. As of December 31, 2016, the Company had approximately $32.0 million, which exceeded these insured limits. Accounts receivable The Company typically requires its customers to remit payments within the first 30 to 37 days, depending on the customer and the products purchased. In addition, the Company offers wholesale distributors a prompt payment discount if they make payments within these deadlines. This discount is generally 2% but may be higher in some instances due to product launches or customer and/or industry expectations. Because the Company’s wholesale distributors typically take the prompt payment discount, the Company accrues 100% of the prompt payment discounts, based on the gross amount of each invoice, at the time of sale, and the Company applies earned discounts at the time of payment. The allowance for prompt payment discounts was $0.2 million and $0.05 million as of December 31, 2017 and 2016, respectively. The Company performs ongoing credit evaluations and does not require collateral. As appropriate, the Company establishes provisions for potential credit losses. As such, there were no allowances for doubtful accounts as of December 31, 2017 or 2016. The Company writes off accounts receivable when management determines they are uncollectible and credits payments subsequently received on such receivables to bad debt expense in the period received. Write-offs during the years ending December 31, 2017, 2016 and 2015 were $0, $0.02 million and $0, respectively. Inventory Inventories are stated at the lower of cost or net realizable 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 more than the expected net realizable value and inventory that is more than expected demand based upon projected product sales. The Company recorded $0.2 million in inventory obsolescence as of December 31, 2017. There were no allowances recorded as of December 31, 2016. Inventory is composed of the following at December 31: 2017 2016 Raw Materials & Supplies $ 1,338 $ 978 Work-in-process 3,135 1,660 Finished Goods 1,861 730 Finished Goods Reserve (243 ) — Total Inventories $ 6,091 $ 3,368 Property and equipment The Company records property and equipment at cost less accumulated depreciation, which is computed on a straight-line basis over its estimated useful lives, generally 3 to 10 years. The Company evaluates the carrying value of the idle equipment when events or changes in circumstances indicate the related carrying amount may not be recoverable. During the year ended December 31, 2017, $0.7 million of idle equipment was placed back into production to support manufacturing of BELBUCA ® ® re-tooled, ® Intangibles and goodwill The Company reviews intangible assets with finite lives (“other intangible assets”) for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company uses an estimate of the undiscounted cash flows over the remaining life of its other intangible assets, or related group of assets where applicable, in measuring whether the assets to be held and used will be realizable. In the event of impairment, the Company would discount the future cash flows using its then estimated incremental borrowing rate to estimate the amount of the impairment. There were no impairment charges recognized on finite lived intangibles in 2017, 2016 or 2015. Intangible assets with finite useful lives are amortized over the estimated useful lives as follows: Estimated Licenses 15 years BELBUCA ® 10 years U.S. product rights 8-12 years EU product rights 7-11 Goodwill is evaluated for impairment at least annually or more frequently if events or changes in circumstances indicate that the carrying amount may not be recoverable. During the evaluation of the potential impairment of goodwill, either a qualitative or a quantitative assessment may be performed. If a qualitative evaluation determines that it is more likely than not that no impairment exists, then no further analysis is performed. If a qualitative evaluation is unable to determine whether it is more likely than not that impairment has occurred, a quantitative evaluation is performed. If the carrying value exceeds the fair value, an impairment charge is recorded based on that difference. There were no goodwill impairment charges in 2017, 2016 or 2015. 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. Deferred revenue is recognized when the product is sold to the end user, based upon prescriptions filled. To estimate product sold to end users, the Company relies on third-party information, including prescription data and information obtained from significant distributors with respect to their inventory levels and sales to customers. Deferred revenue is recorded net of estimated allowances for rebates, price adjustments, chargebacks, prompt payment and other discounts. Estimated allowances are recorded and classified as accrued expenses in the accompanying balance sheets as of December 31, 2017 and 2016 (see note 3). The Company deferred sales, until January 1, 2017, of BUNAVAIL ® ® Revenue recognition Net product sales Beginning in the first quarter of 2017, the Company had determined that it had sufficient experience with BELBUCA ® ® ex-factory ® ® can reasonably estimate the amount of future product returns, and therefore, the risk of estimating product returns has been substantially eliminated. The effect in income from operations and on net income is that the Company can recognize revenue earlier on the 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 considering 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 License and development agreements The Company periodically enters into license and development agreements to develop and commercialize its products. The arrangements typically are multi-deliverable arrangements that are funded through upfront payments, milestone payments and other forms of payment. The Company currently has multiple license and development agreements that are described in notes 6, 8 and 9. Depending on the nature of the contract these revenues are classified as research and development reimbursements or contract revenue. Deferred cost of sales Prior to January 1, 2017, the Company deferred its cost of sales relating to BUNAVAIL ® ex-factory ® ® The Company incurred $1.7 million of deferred costs of sales for the year ended December 31, 2016, which is included in other current assets in the accompanying balance sheets. There was no deferred cost of sales for the year ended December 31, 2017. Cost of sales Cost of sales includes the direct costs attributable to the production of BELBUCA ® ® ® ® For BREAKYL ™ ™ out-licensed Research and development expenses Research and development expenses consist of product development expenses incurred in identifying, developing and testing product candidates. Product development expenses consist primarily of labor, benefits and related employee expenses for personnel directly involved in product development activities; fees paid to professional service providers for monitoring and analyzing clinical trials; expenses incurred under joint development agreements; regulatory costs; costs of contract research and manufacturing of inventory used in testing and clinical trials; and the cost of facilities used by the Company’s product development personnel. Product development expenses are expensed as incurred and reflect costs directly attributable to product candidates in development during the applicable period and to product candidates for which the Company has discontinued development. Additionally, product development expenses include the cost of qualifying new current Good Manufacturing Practice (“cGMP”) third-party manufacturers for the Company’s product candidates, including expenses associated with any related technology transfer. All indirect costs (such as salaries, benefits or other costs related to the Company’s accounting, legal, human resources, purchasing, information technology and other general corporate functions) associated with individual product candidates are included in general and administrative expenses. Research and development expenses were $13.0 million, $18.9 million and $20.6 million for the years ended December 31, 2017, 2016 and 2016 respectively. Advertising Advertising costs, which include promotional expenses and the cost of placebo samples, are expensed as incurred. Advertising expenses were $3.8 million, $4.2 million and $4.9 million for the years ended December 31, 2017, 2016 and 2015, respectively, and are included in selling, general and administrative expenses in the accompanying consolidated statements of operations. Shipping and handling costs Shipping and handling costs, which include expenses from our wholesalers, are expensed as incurred. Shipping and handling costs were $0.2 million, $0.05 and $0.05 million for the years ended December 31, 2017, 2016 and 2015, respectively, and are included in selling, general and administrative expenses in the accompanying consolidated statements of operations. Stock-based compensation The Company has a stock-based compensation plan under which various types of equity-based awards are granted, including stock options, restricted stock units (RSUs) and performance-based RSUs. The fair value of stock option and RSUs, which are subject only to service conditions with graded vesting, are recognized as compensation expense, generally on a straight-line basis over the service period, net of estimated forfeitures. Forfeitures are recognized as they occur. The fair values of performance-based RSUs are recognized as compensation expense from the grant date to the end of the performance period. The Company uses the fair-value based method to determine compensation for all arrangements under which employees and others receive shares of stock or equity instruments (warrants and options). The grant date fair value of an RSU equals the closing price of our common stock on the trading day preceding the grant date. The fair value of each option and warrant is estimated on the date of grant using the Black-Scholes valuation model that uses assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate. Expected volatility is based on historical volatility of the Company’s Common Stock and other factors estimated over the expected term of the options. The expected term of options granted is derived using the “simplified method” which computes expected term as the average of the sum of the vesting term plus the contract term. The risk-free rate is based on the U.S. Treasury yield. In applying the Black-Scholes options-pricing model, assumptions are as follows: 2017 2016 2015 Expected price volatility 68.76%-78.79% 62.65%-80.78% 73.00%-76.78% Risk-free interest rate 1.77%-2.05% 0.56%-1.70% 1.25%-1.68% Weighted average expected life in years 6 years 6 years 6 years Dividend yield — — — The Company estimated fair values of derivative financial instruments using the Black-Scholes option valuation technique because it embodied all of the requisite assumptions (including trading volatility, estimated terms and risk-free rates) necessary to fairly value these instruments. In addition, option-based techniques were highly volatile and sensitive to changes in the Company’s trading market price which was high-historical volatility. Since derivative financial instruments were initially and subsequently carried at fair values, the Company’s operating results reflected the volatility in these estimates and assumption changes. Recent accounting pronouncements In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2014-09, 2015-14, 2014-09 2014-09 The Company used the modified retrospective approach upon adoption of this guidance effective January 1, 2018 using a cumulative effect adjustment to accumulated deficit. The Company utilized a comprehensive approach to assess the impact of the guidance on its contract portfolio. The Company reviewed its current accounting policies and practices to identify potential differences resulting from the application of the new requirements to its revenue contracts, including evaluation of performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price, allocating the transaction price to each separate performance obligation and accounting treatment of costs to obtain and fulfill contracts. In addition, the Company will update certain disclosures, as applicable, included in our financial statements to meet the requirements of the new guidance beginning in January 1, 2018. Under the new guidance, the Company is required to evaluate the impact of estimating variable consideration related to our product sales and licensing contracts. The Company will use the expected value method to estimate the total revenue of the contract, constrained by the probability that there would not be a significant revenue reversal in a future period. The Company will continue to evaluate the expected value of revenue over the term of the contract and adjust revenue recognition as appropriate. Based on this evaluation, the adoption will not have a material impact on the Company’s financial position, results of operations, cash flows, accounting policies, business processes, internal controls or disclosures. The FASB’s new leases standard, ASU 2016-02 2016-02 right-of-use 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 2017-04 |