Cover Page
Cover Page - USD ($) | 12 Months Ended | |||
Dec. 31, 2019 | Mar. 06, 2020 | Jun. 28, 2019 | Jun. 29, 2018 | |
Cover page. | ||||
Document Type | 10-K | |||
Document Annual Report | true | |||
Document Transition Report | false | |||
Entity File Number | 001-31361 | |||
Entity Registrant Name | BioDelivery Sciences International, Inc. | |||
Entity Incorporation, State or Country Code | DE | |||
Entity Tax Identification Number | 35-2089858 | |||
Entity Address, Address Line One | 4131 ParkLake Avenue, Suite 225, | |||
Entity Address, City or Town | Raleigh | |||
Entity Address, State or Province | NC | |||
Entity Address, Postal Zip Code | 27612 | |||
City Area Code | 919 | |||
Local Phone Number | 582-9050 | |||
Title of 12(b) Security | Common stock, par value $0.001 | |||
Trading Symbol | BDSI | |||
Security Exchange Name | NASDAQ | |||
Entity Well-known Seasoned Issuer | No | |||
Entity Voluntary Filers | No | |||
Entity Current Reporting Status | Yes | |||
Entity Interactive Data Current | Yes | |||
Entity Filer Category | Accelerated Filer | |||
Entity Small Business | false | |||
Entity Emerging Growth Company | false | |||
Entity Shell Company | false | |||
Amendment Flag | false | |||
Document Period End Date | Dec. 31, 2019 | |||
Document Fiscal Year Focus | 2019 | |||
Document Fiscal Period Focus | FY | |||
Entity Central Index Key | 0001103021 | |||
Current Fiscal Year End Date | --12-31 | |||
Entity Common Stock, Shares Outstanding | 96,344,995 | |||
Entity Public Float | $ 359,814,864 | $ 338,146,138 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash | $ 63,888 | $ 43,822 |
Accounts receivable, net | 38,790 | 13,627 |
Inventory, net | 11,312 | 5,406 |
Prepaid expenses and other current assets | 3,769 | 3,188 |
Total current assets | 117,759 | 66,043 |
Property and equipment, net | 2,075 | 3,072 |
Goodwill | 2,715 | 2,715 |
License and distribution rights, net | 60,309 | 36,000 |
Other intangible assets, net | 47 | 703 |
Total assets | 182,905 | 108,533 |
Current liabilities: | ||
Accounts payable and accrued liabilities | 53,993 | 21,539 |
Total current liabilities | 53,993 | 21,539 |
Notes payable, net | 58,568 | 51,652 |
Other long-term liabilities | 580 | 5,600 |
Total liabilities | 113,141 | 78,791 |
Commitments and contingencies (Notes 7 and 17) | ||
Stockholders' equity: | ||
Preferred Stock, 5,000,000 shares authorized; 2,714,300 shares issued; Series A Non-Voting Convertible Preferred Stock. $0.001 par value, 2,093,155 shares outstanding at both December 31, 2019 and December 31, 2018, respectively; Series B Non-Voting Convertible Preferred Stock, $0.001 par value, 618 and 3,100 shares outstanding at December 31, 2019 and December 31, 2018 respectively. | 2 | 2 |
Common Stock, $.001 par value; 175,000,000 and 125,000,000 shares authorized at December 31, 2019 and December 31, 2018 respectively; 96,189,074 and 70,793,725 shares issued;96,173,583 and 70,778,234 shares outstanding at December 31, 2019 and December 31, 2018, respectively. | 96 | 71 |
Additional paid-in capital | 436,306 | 381,004 |
Treasury stock, at cost, 15,491 shares | (47) | (47) |
Accumulated deficit | (366,593) | (351,288) |
Total stockholders’ equity | 69,764 | 29,742 |
Total liabilities and stockholders’ equity | $ 182,905 | $ 108,533 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
Preferred stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Preferred Stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Common stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Common Stock, shares authorized (in shares) | 175,000,000 | 125,000,000 |
Common Stock, shares issued (in shares) | 96,189,074 | 70,793,725 |
Common stock, shares outstanding (in shares) | 96,173,583 | 70,778,234 |
Treasury stock, shares (in shares) | 15,491 | 15,491 |
Preferred stock, shares issued (in shares) | 2,714,300 | 2,714,300 |
Series B Non-Voting Convertible Preferred Stock | ||
Preferred stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Preferred Stock, shares outstanding (in shares) | 618 | 3,100 |
SeriesA Non-Voting Convertible Preferred Stock | ||
Preferred stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Preferred Stock, shares outstanding (in shares) | 2,093,155 | 2,093,155 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Revenues: | |||
Net product sales | $ 111,389,000 | $ 55,640,000 | $ 61,985,000 |
Cost of sales | 21,590,000 | 15,783,000 | 19,496,000 |
Expenses: | |||
Research and development | 0 | 4,903,000 | 13,040,000 |
Selling, general and administrative | 86,063,000 | 58,602,000 | 58,869,000 |
Total expenses | 86,063,000 | 63,505,000 | 71,909,000 |
Income (loss) from operations | 3,736,000 | (23,648,000) | (29,420,000) |
Interest expense | (19,040,000) | (10,192,000) | (8,577,000) |
Bargain purchase gain | 0 | 0 | 27,336,000 |
Other income (expense), net | 4,000 | (14,000) | (26,000) |
Loss before income taxes | (15,300,000) | (33,854,000) | (10,687,000) |
Income tax (expense) benefit | (5,000) | (13,000) | 15,972,000 |
Net (loss) income | (15,305,000) | (33,867,000) | 5,285,000 |
Beneficial conversion feature of convertible preferred stock | 0 | (12,500,000) | 0 |
Net (loss) income attributable to common stockholders | $ (15,305,000) | $ (46,367,000) | $ 5,285,000 |
Basic: | |||
Weighted average common stock shares outstanding (in shares) | 83,213,704 | 63,165,063 | 55,355,802 |
Basic (loss) earnings per share (in usd per share) | $ (0.18) | $ (0.73) | $ 0.10 |
Diluted: | |||
Diluted weighted average common stock shares outstanding (in shares) | 83,213,704 | 63,165,063 | 56,402,479 |
Diluted (loss) earnings per share (in usd per share) | $ (0.18) | $ (0.73) | $ 0.09 |
Product Sales | |||
Revenues: | |||
Net product sales | $ 107,888,000 | $ 51,410,000 | $ 34,922,000 |
Product Royalty Revenues | |||
Revenues: | |||
Net product sales | 3,341,000 | 3,389,000 | 5,070,000 |
Research And Development Reimbursements | |||
Revenues: | |||
Net product sales | 0 | 0 | 799,000 |
Contract Revenues | |||
Revenues: | |||
Net product sales | $ 160,000 | $ 841,000 | $ 21,194,000 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' (Deficit) Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Treasury Stock | Accumulated Deficit | Series A Preferred Stock | Series B Preferred Stock |
Beginning balance, preferred stock (in shares) at Dec. 31, 2016 | 2,093,155 | 0 | |||||
Beginning Balance at Dec. 31, 2016 | $ (17,665) | $ 54 | $ 292,667 | $ (47) | $ (310,341) | $ 2 | $ 0 |
Beginning balance (in shares) at Dec. 31, 2016 | 54,133,511 | ||||||
Stock-based compensation | 14,801 | 14,801 | |||||
Stock option exercises | $ 439 | 439 | |||||
Stock option exercises (in shares) | 202,519 | 202,519 | |||||
Restricted stock awards | $ 2 | (2) | |||||
Restricted stock awards (in shares) | 1,568,042 | ||||||
Issuance of warrants | $ 6,017 | 6,017 | |||||
Net income (loss) | 5,285 | 5,285 | |||||
Ending balance, preferred stock (in shares) at Dec. 31, 2017 | 2,093,155 | 0 | |||||
Ending Balance at Dec. 31, 2017 | 8,877 | $ 56 | 313,922 | (47) | (305,056) | $ 2 | $ 0 |
Ending balance (in shares) at Dec. 31, 2017 | 55,904,072 | ||||||
Stock-based compensation | 5,941 | 5,941 | |||||
Stock option exercises | $ 670 | 670 | |||||
Stock option exercises (in shares) | 350,441 | 350,441 | |||||
Restricted stock awards | $ 2 | (2) | |||||
Restricted stock awards (in shares) | 1,733,731 | ||||||
Common stock issuance upon retirement | $ 2 | (2) | |||||
Common stock issuance upon retirement, shares | 2,119,925 | 2,249,925 | |||||
Series B issuance, net of issuance costs | $ 47,986 | 47,986 | |||||
Series B issuance, net of issuance costs (in shares) | 5,000 | ||||||
Series B conversion to Common Stock | $ 11 | (11) | |||||
Series B conversion to Common Stock (in shares) | 10,555,556 | (1,900) | |||||
Series B beneficial conversion feature | (12,500) | 12,500 | (12,500) | ||||
Cumulative effect of accounting change | 135 | 135 | |||||
Net income (loss) | (33,867) | (33,867) | |||||
Ending balance, preferred stock (in shares) at Dec. 31, 2018 | 2,093,155 | 3,100 | |||||
Ending Balance at Dec. 31, 2018 | $ 29,742 | $ 71 | 381,004 | (47) | (351,288) | $ 2 | $ 0 |
Ending balance (in shares) at Dec. 31, 2018 | 70,778,234 | 70,793,725 | |||||
Stock-based compensation | $ 5,418 | 5,418 | |||||
Stock option exercises | $ 2,319 | 2,319 | |||||
Stock option exercises (in shares) | 799,800 | 799,800 | |||||
Restricted stock awards | $ 1 | (1) | |||||
Restricted stock awards (in shares) | 806,661 | ||||||
Common stock issuance upon retirement, shares | 2,119,925 | ||||||
Series B conversion to Common Stock | $ 14 | (14) | |||||
Series B conversion to Common Stock (in shares) | 13,788,888 | (2,482) | |||||
Series B beneficial conversion feature | $ (12,500) | ||||||
Equity offering, net of finance costs, value | 47,590 | $ 10 | 47,580 | ||||
Equity offering, net of finance costs (in shares) | 10,000,000 | ||||||
Net income (loss) | (15,305) | (15,305) | |||||
Ending balance, preferred stock (in shares) at Dec. 31, 2019 | 2,093,155 | 618 | |||||
Ending Balance at Dec. 31, 2019 | $ 69,764 | $ 96 | $ 436,306 | $ (47) | $ (366,593) | $ 2 | $ 0 |
Ending balance (in shares) at Dec. 31, 2019 | 96,173,583 | 96,189,074 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Operating activities: | |||
Net (loss) income | $ (15,305) | $ (33,867) | $ 5,285 |
Adjustments to reconcile net (loss) income to net cash flows provided by (used in) operating activities | |||
Depreciation | 1,846 | 740 | 693 |
Accretion of debt discount and loan costs | 11,508 | 4,138 | 2,392 |
Amortization of intangible assets | 6,981 | 5,157 | 5,425 |
Provision for (recovery from) inventory obsolescence | 197 | (56) | 243 |
Impairment loss on equipment | 0 | 78 | 0 |
Stock-based compensation expense | 5,416 | 5,941 | 14,801 |
Deferred income taxes | 0 | 40 | (15,972) |
Bargain purchase gain | 0 | 0 | (27,336) |
Changes in assets and liabilities, net of effect of acquisition: | |||
Accounts receivable | (25,163) | (4,640) | (5,884) |
Inventories | (6,102) | 741 | 2,448 |
Prepaid expenses and other assets | (581) | 422 | 526 |
Accounts payable and accrued expenses | 32,275 | (2,807) | 6,644 |
Deferred revenue | 0 | 0 | (21,716) |
Net cash flows provided by (used in) operating activities | 11,072 | (24,113) | (32,451) |
Investing activities: | |||
Product acquisitions | (30,685) | (1,951) | (5,853) |
Acquisitions of equipment | (79) | (112) | (11) |
Net cash flows used in investing activities | (30,764) | (2,063) | (5,864) |
Financing activities: | |||
Proceeds from exercise of stock options | 2,321 | 670 | 439 |
Proceeds from issuance of common stock, less underwriters discount | 48,000 | 0 | 0 |
Proceeds from issuance of Series B preferred stock | 0 | 50,000 | 0 |
Payment on note payable | (67,346) | 0 | (30,000) |
Proceeds from notes payable | 59,987 | 0 | 60,000 |
Equity finance costs | (410) | (1,417) | 0 |
Payment of deferred financing fees | 0 | (450) | (2,948) |
Loss on refinancing of former debt | (2,794) | 0 | 0 |
Net cash flows provided by financing activities | 39,758 | 48,803 | 27,491 |
Net change in cash and cash equivalents | 20,066 | 22,627 | (10,824) |
Cash and cash equivalents at beginning of year | 43,822 | 21,195 | 32,019 |
Cash and cash equivalents at end of year | 63,888 | 43,822 | 21,195 |
Cash paid for interest | 6,809 | 6,053 | 5,285 |
Non-cash Financing and Investing Activities: | |||
Adjustments to additional paid in capital dividends in excess of retained earnings | $ 12,500 | $ 12,500 | |
Common stock issuance upon retirement, shares | 2,119,925 | 2,119,925 | |
Common stock issuance upon retirement | $ 5,300 | $ 5,300 | |
Accrued financing expenses | 600 | ||
Fair value of bargain purchase price of BELBUCA acquisition | 27,300 | 27,300 | |
Fair value of warrants, in connection with CRG term loan | $ 6,000 | $ 6,000 | |
Series B Non-Voting Convertible Preferred Stock | |||
Non-cash Financing and Investing Activities: | |||
Adjustments to additional paid in capital dividends in excess of retained earnings | 12,500 | ||
Accrued financing expenses | $ 600 |
Nature of Business and Summary
Nature of Business and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Nature of Business and Summary of Significant Accounting Policies | 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. The Company is a rapidly growing specialty pharmaceutical company dedicated to patients living with chronic pain and associated conditions. The Company has built a portfolio of products that includes utilizing its novel and proprietary BioErodible MucoAdhesive, or BEMA, drug-delivery technology to develop and commercialize new applications of proven therapies aimed at addressing important unmet medical needs. The Company commercializes in the U.S. using its own sales force while working in partnership with third parties to commercialize its products outside the U.S. As used herein, the Company’s common stock, par value $0.001 per share, is referred to as the “Common Stock” and the Company’s preferred stock, par value $0.001 per share, is referred to as the “Preferred Stock”. Principles of consolidation The consolidated financial statements include the accounts of the Company, Arius One and Arius Two. 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 made by the Company include: revenue recognition associated with 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. 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 four active pharmaceutical ingredient (“API”) suppliers for BELBUCA, Symproic and BUNAVAIL ® . The Company purchases its pharmaceutical ingredients pursuant to long-term supply agreements with a limited number of suppliers. The failure of a supplier, including a subcontractor, to deliver on schedule could delay or interrupt the development or commercialization process and thereby adversely affect the Company’s operating results. In addition, a disruption in the commercial supply of or a significant increase in the cost of the API from any of these sources could have a material adverse effect on the Company’s BELBUCA and Symproic business, which would affect the Company’s financial position and results of operations. In 2019, the Company utilized only one contract manufacturer to create the BELBUCA and BUNAVAIL laminates and a second contract manufacturer to package the laminates into final product. The Company utilizes only one contract manufacturer to create the Symproic tablets and only one contract manufacturer to package the tablets into final product. Although the Company has long term supply agreements with these two vendors, any problems or regulatory issues at either of these vendors could create significant BELBUCA and Symproic supply delays. Amounts due to these vendors represented approximately 30.3% and 6.3% of total accounts payable as of December 31, 2019 and 2018, respectively. In 2019, the Company sold its BELBUCA, Symproic and BUNAVAIL products primarily to large national wholesalers, which in turn may resell the products to smaller or regional wholesalers, retail pharmacies, chain drug stores, government agencies and other third parties. The following table lists the Company’s customers that individually comprise greater than 10% of total accounts receivable: December 31, Customers 2019 2018 Customer A 42 % 47 % Customer B 35 % 22 % Customer C 18 % 25 % Total 95 % 94 % These three customers accounted for 94%, 92% and 92% of total annual sales during the years ended December 31, 2019, 2018 and 2017 respectively. In March 2020 the Company announced that it will discontinue marketing of BUNAVAIL in 2020. 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, 2019, the Company had approximately $65.1 million, which exceeded these insured limits. As of December 31, 2018, the Company had approximately $43.6 million, which exceeded these insured limits. Accounts receivable The Company offers wholesale distributors a prompt payment discount if they make payments within a prescribed number of days. 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 $0.9 million and $0.3 million as of December 31, 2019 and 2018, respectively. The Company performs ongoing credit evaluations and does not require collateral. As appropriate, the Company establishes provisions for potential credit losses. There were no allowances for doubtful accounts as of December 31, 2019 or 2018. 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. 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 method and specifically allocated to remaining inventory. Inventory consists of raw materials, work in process and finished goods. Raw materials include amounts of active pharmaceutical ingredient for a product to be manufactured, work in process includes the bulk inventory of laminate (the Company’s drug delivery film) 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 more than the expected net realizable value and inventory that is more than expected demand based upon projected product sales. The Company recorded $0.4 million and $0.2 million in reserves for inventory obsolescence as of December 31, 2019 and 2018, respectively. The 2019 reserve includes an additional $0.2 million associated with the announced discontinuation of marketing of BUNAVAIL. Inventory is composed of the following at December 31: 2019 2018 Raw Materials & Supplies $ 624 $ 645 Work-in-process 6,198 2,093 Finished Goods 4,874 2,855 Finished Goods Reserve (384) (187) Total Inventories $ 11,312 $ 5,406 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 equipment when events or changes in circumstances indicate the related carrying amount may not be recoverable. In connection with the discontinuation of the marketing of BUNAVAIL, the company recorded an additional $1.5 million of depreciation related to certain equipment used in the production of BUNAVAIL. The Company has certain manufacturing equipment that isn’t currently in production, which has been deemed idle. There was no impairment of equipment recorded during the year ended December 31, 2019 or 2018. 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 2019, 2018 or 2017. Intangible assets with finite useful lives are amortized over the estimated useful lives as follows: Estimated Licenses 15 years BELBUCA license and distribution rights 10 years Symproic license and distribution rights 12 years U.S. product rights 8-12 years EU product rights 7-11 years 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 2019, 2018 or 2017. Revenue recognition The Company recognizes revenue in accordance with ASC, Topic 606, Revenue from Contracts with Customers ("ASC606"), which was adopted on January 1, 2018, using the modified retrospective transition method. Product sales The Company recognizes revenue on product sales when control of the promised goods is transferred to its customers in an amount that reflects the consideration expected to be received in exchange for transferring those goods. The Company accounts for a contract when it has approval and commitment from both parties, the rights of the parties are identified, payment terms are identified, the contract has commercial substance and collectability of consideration is probable. When determining whether the customer has obtained control of the goods, the Company considers any future performance obligations. Generally, there is no post-shipment obligation on product sold. Performance obligations A performance obligation is a promise in a contract to transfer a distinct good or service to the customer. A contract’s transaction price is allocated to each distinct performance obligation and recognized as revenue when, or as, the performance obligation is satisfied. The majority of the Company’s product sales contracts have a single performance obligation as the promise to transfer the individual goods is not separately identifiable from other promises in the contracts and, therefore, not distinct. The Company’s performance obligations are satisfied at a point in time. The multiple performance obligations are not allocated based off of the obligations but based off of standard selling price. Adjustments to product sales The Company recognizes product sales net of estimated allowances for rebates, price adjustments, returns, chargebacks, vouchers and prompt payment discounts. A significant majority of the Company’s adjustments to gross product revenues are the result of accruals for its commercial contracts, retail consumer subsidy programs, and Medicaid and Medicare rebates. 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. In addition, the Company receives daily information from the wholesalers regarding their sales and actual on hand inventory levels of the Company’s products. This enables the Company to execute accurate provisioning procedures. Product returns -Consistent with industry practice, the Company offers contractual return rights that allow its customers to return the products within an 18-month period that begins six months prior to and ends twelve months after expiration of the products. In connection with the March 2020 announcement of the discontinuation of marketing of BUNAVAIL, the 2019 results include a one-time reserve of $2.2 million for additional BUNAVAIL product returns. Rebates - The liability for government program rebates is calculated based on historical and current rebate redemption and utilization rates contractually submitted by each program’s administrator. Price adjustments and chargebacks- The Company’s estimates of price adjustments and chargebacks are based on its estimated mix of sales to various third-party payers, which are entitled either contractually or statutorily to discounts from the Company’s listed prices of its products. If the sales mix to third-party payers is different from the Company’s estimates, the Company may be required to pay higher or lower total price adjustments and/or chargebacks than it had estimated, and such differences may be significant. The Company, from time to time, offers certain promotional product-related incentives to its customers. During 2019, the Company had voucher programs for BELBUCA Symproic and BUNAVAIL whereby the Company offers a point-of-sale subsidy to retail consumers. The Company estimates its liabilities for these voucher programs based on the current utilization and historical redemption rates as reported to the Company by a third-party claims processing organization. The Company accounts for the costs of these special promotional programs as price adjustments, which are a reduction of gross revenue. Prompt payment discounts-The Company typically offers its wholesale customers a prompt payment discount of 2% as an incentive to remit payments within a prescribed number of days after the invoice date depending on the customer and the products purchased. Gross to net accruals-A significant majority of the Company’s gross to net adjustments to gross product revenues are the result of accruals for its voucher program and rebates related to Medicare Part D, Part D Coverage Gap, Medicaid and commercial contracts, with most of those programs having an accrual to payment cycle of anywhere from one to three months. In addition to this relatively short accrual to payment cycle, the Company receives daily information from the wholesalers regarding their sales of the Company’s products and actual on hand inventory levels of its products. This enables the Company to execute accurate provisioning procedures. Consistent with the pharmaceutical industry, the accrual to payment cycle for returns is longer and can take several years depending on the expiration of the related products. 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 license agreements that are described in note 7, of which these revenues are classified as contract revenue. Cost of sales In 2019, cost of sales included the direct costs attributable to the production of BELBUCA, Symproic and BUNAVAIL. It included raw materials, production costs at the Company’s three contract manufacturing sites, quality testing directly related to the products, inventory adjustment charges, and depreciation on equipment that the Company had purchased to produce BELBUCA and BUNAVAIL. It also includes any batches not meeting specifications and raw material yield losses. Yield losses and batches not meeting specifications are expensed as incurred. Cost of sales is recognized when sold to the wholesaler from our distribution center. For BREAKYL and PAINKYL (the Company’s out-licensed breakthrough cancer pain therapies), cost of sales includes all costs related to creating the product at the Company’s contract manufacturing location in Germany. The Company’s contract manufacturer bills the Company for the final product, which includes materials, direct labor costs, and certain overhead costs as outlined in applicable supply agreements. Cost of sales also includes royalty expenses that the Company owes to third parties. Research and development expenses Research and development expenses have historically consisted of product development expenses incurred in identifying, developing and testing product candidates. Product development expenses consisted 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; regulatory costs; costs of contract research and manufacturing of inventory used in testing and clinical trials. As of January 1, 2019, the Company has focused entirely on commercialized products rather than research and development. As such, there were no expenses incurred in research and development during the year ended December 31, 2019. Research and development expense for the years ended December 31, 2018 and 2017 totaled $4.9 million and $13.0 million, respectively. Advertising Advertising costs, which include promotional expenses and the cost of placebo samples, are expensed as incurred. Advertising expenses were $10.8 million, $4.5 million and $3.8 million for the years ended December 31, 2019, 2018 and 2017, 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 $0.03 million, $0.02 million and $0.01 million for the years ended December 31, 2019, 2018 and 2017, 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: 2019 2018 2017 Expected price volatility 61.66%-64.10% 60.34%-68.77% 68.76%-78.79% Risk-free interest rate 1.36%-2.66% 2.05%-3.00% 1.77%-2.05% Weighted average expected life in years 6 years 6 years 6 years Dividend yield — — — Fair Value of Financial Instruments The Company measures the fair value of instruments in accordance with GAAP which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. GAAP defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. GAAP also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The Company considers the carrying amount of its cash and cash equivalents to approximate fair value due to short-term nature of this instrument. GAAP describes three levels of inputs that may be used to measure fair value: Level 1 – quoted prices in active markets for identical assets or liabilities Level 2 – quoted prices for similar assets and liabilities in active markets or inputs that are observable Level 3 – inputs that are unobservable (for example cash flow modeling inputs based on assumptions) The following table summarizes the cash and cash equivalents measured at fair value on a recurring basis as of December 31, 2019: Level 1 Level 2 Level 3 Balance Cash and cash equivalents $ 63,888 — — $63,888 Accounting Pronouncements adopted in 2019 In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). The authoritative guidance significantly amends the current accounting for leases. Under the new provisions, all lessees will report a right-of-use asset and a liability for the obligation to make payments for all leases with the exception of those leases with a term of 12 months or less. All other leases will fall into one of two categories: (i) a financing lease or (ii) an operating lease. In July 2018, the FASB issued ASU No. 2018-10, Codification Improvements to Topic 842 (Leases) , which amends narrow aspects of the guidance issued in the amendments in ASU 2016-02, and ASU No. 2018-11, Leases (Topic 842): Targeted Improvements, which allows entities to recognize a cumulative-effect adjustment from the application of ASU 2016-02 to the opening balance of retained earnings in the period of adoption. Effective January 1, 2019, the Company adopted Topic 842 using the modified retrospective method as of January 1, 2019 and will not restate comparative periods. The Company elected the optional package of practical expedients, which allowed the Company to not reassess: (i) whether any expired or existing contracts are considered or contain leases; (ii) lease classification for any expired or existing leases; and (iii) initial direct costs for any existing leases. The new standard also allows entities to make certain policy elections, including a policy to not separate lease and non-lease components, which the Company did not elect for its facility and office equipment lease. Refer to footnote three “Leases” for further information. Accounting Pronouncements not yet adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses of Financial Instruments; in November 2018 the FASB issued a subsequent amendment ASU No. 2018-19, Codi fication Improvements to Topic 326, Financial Instruments—Credit Losses; in April 2019 the FASB issued ASU No. 2019-04, Codification Improvements to Topic 326, Financial Instruments—Credit Losses. In May 2019 the FASB issued ASU No. 2019-05, Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief; and in November 2019 the FASB issued ASU No. 2019-11, Codification Improvements to Topic 326, Financial Instruments—Credit Losses. The new guidance changes the methodology for measuring credit losses on financial instruments and the timing of when such losses are recorded. In November 2019 the FASB issued ASU No. 2019-10, Financial Instruments—Credit Losses (Topic 326). This guidance is effective for fiscal years beginning after December 15, 2022 and early adoption is permitted. The Company is currently evaluating the timing and effect the new guidance will have on its consolidated financial statements. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement, which modifies the disclosure requirements on fair value measurements. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019 and early adoption is permitted. The Company is currently evaluating but does not expect the new guidance to have a material impact on its consolidated financial statements. In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606, which amends ASC 808 to clarify ASC 606 should apply in entirety to certain transactions between collaborative arrangement participants. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The Company is currently evaluating but does not expect the new guidance to have a material impact on its consolidated financial statements. In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740)— Simplifying the Accounting for Income Taxes, which is intended to simplify accounting for income taxes. It removes certain exceptions to the general principles in Topic 740 and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020 and early adoption is permitted. The Company is currently evaluating but does not expect the new guidance to have a material impact on its consolidated financial statements. |
Revenue from Contracts with Cus
Revenue from Contracts with Customers | 12 Months Ended |
Dec. 31, 2019 | |
Revenue from Contract with Customer [Abstract] | |
Revenue from Contracts with Customers | Revenue from contracts with customers: The main types of revenue contracts are: • Product sales- Product sales amounts relate to sales of BELBUCA, Symproic and BUNAVAIL. These sales are recognized as revenue when control is transferred to the wholesaler in an amount that reflects the consideration expected to be received. In March 2020 the Company announced it will discontinue marketing of BUNAVAIL in 2020. • Product royalty revenues- Product royalty revenue amounts are based on sales revenue of the PAINKYL TM product under the Company’s license agreement with TTY and the BREAKYL TM product under the Company’s license agreement with Meda AB, which was acquired by Mylan N.V. (which we refer to herein as Mylan). Product royalty revenues are recognized when control of the product is transferred to the license partner in an amount that reflects the consideration expected to be received. Supplemental sales-based product royalty revenue may also be earned upon the subsequent sale of the product at agreed upon contractual rates. • Contract revenue- Contract revenue amounts are related to milestone payments under the Company’s license agreements with its partners including any associated financing component. The Company implemented ASC 606 January 1, 2018. As such, the accounting treatment for 606 is already reflected in the consolidated financials for the year ended December 31, 2019. The beginning and ending balances of the Company’s accounts receivables with customers from contracts during the periods presented is as follows (in thousands): Balance at Year ended December 31, Balance at December 31, Accounts receivable with customers $ 8,987 $ 4,640 $ 13,627 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Leases | Leases: On January 1, 2019, the Company adopted ASC Topic 842, which is intended to improve financial reporting about leasing transactions. Under the standard, organizations that lease assets, referred to as “Lessees” shall recognize on the balance sheet the assets and liabilities for the rights and obligations created by those leases. In addition, the standard requires disclosures including financial statements to assess the amount, timing and uncertainty of cash flows arising from leases. The Company elected to use the practical expedients permitted under the transition guidance within the new standard, which among other things, allows the Company to carryforward the historical lease classification. The Company made an accounting policy election to account for leases with an initial term of 12 months or less similar to existing guidance for operating leases today. The Company recognized those lease payments in the Consolidated Statements of Operations on a straight-line basis over the lease term. Under the new standard, the Company’s lease liability is based on the present value of such payments and the related right-of-use asset will generally be based on the lease liability. The impact of the adoption of Topic 842 on the accompanying consolidated balance sheet as of January 1, 2019 is as follows (in thousands): December 31, 2018 Adjustments Due to the Adoption of Topic 842 January 1, 2019 Right-of-use asset Lease liability Property and equipment, net $ 3,072 $ 939 $ — $ 4,011 Current liabilities $ 21,539 $ — $ 212 $ 21,751 Other long-term liabilities $ 5,600 $ — $ 822 $ 6,422 The components of lease expense were as follows: Twelve months ended December 31, 2019 2018 Lease Cost Operating lease cost Operating lease $ 328 $ 325 Variable lease costs $ 13 $ 2 Total lease cost $ 341 $ 327 Supplemental cash flow information related to leases were as follows: Twelve months ended December 31, 2019 2018 Other information Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ 351 $ 327 Twelve months ended December 31, 2019 2018 Lease term and discount rate Weighted-average remaining lease term operating leases 3.0 years 4.0 years Weighted-average discount rate operating leases 11.8 % 11.8 % Maturity of Lease Liabilities Future minimum lease payments under non-cancellable leases as of December 31, 2019 were as follows: Maturity of lease liabilities 2020 $360 2021 $370 2022 $219 Total lease payments $949 Less: Interest $(128) Present value of lease liabilities $821 Components of Lease Assets and Liabilities December 31, 2019 Assets Property and equipment, net operating lease-right of use asset $ 720 Liabilities Current liabilities operating lease-current liability $ 281 Other long-term liabilities operating lease-noncurrent liability $ 540 Total lease liabilities $ 821 |
Liquidity
Liquidity | 12 Months Ended |
Dec. 31, 2019 | |
Liquidity And Managements Plans [Abstract] | |
Liquidity | Liquidity: At December 31, 2019, the Company had cash of approximately $63.9 million. The Company generated $11.1 million of cash in operations during the year ended December 31, 2019 and had stockholders’ equity of $69.8 million, versus stockholders’ equity of $29.7 million at December 31, 2018. The Company believes that it has sufficient current cash to manage the business as currently planned. The Company’s cash on hand estimation assumes that the Company does not otherwise face unexpected events, costs or contingencies, any of which could affect the Company’s cash requirements from time to time. Available resources may be consumed more rapidly than currently anticipated, potentially resulting in the need for additional funding. Available resources may be consumed more rapidly than currently anticipated, potentially resulting in the need for additional funding. Additional funding, capital or loans (including, without limitation, milestone or other payments from commercialization agreements) may be unavailable on favorable terms, if at all. |
Accounts Payable and Accrued Li
Accounts Payable and Accrued Liabilities | 12 Months Ended |
Dec. 31, 2019 | |
Payables and Accruals [Abstract] | |
Accounts Payable and Accrued Liabilities | Accounts payable and accrued liabilities: The following table represents the components of accounts payable and accrued liabilities as of December 31: 2019 2018 Accounts payable $ 11,704 $ 3,166 Accrued rebates 28,528 12,261 Accrued compensation and benefits 5,545 3,814 Accrued acquisition costs — 318 Accrued returns 4,438 715 Accrued royalties 535 159 Accrued clinical trial costs — 464 Accrued regulatory fees 331 — Accrued legal 1,484 70 Accrued other 1,428 572 Total accounts payable and accrued expenses $ 53,993 $ 21,539 As of December 31, 2019, three vendors comprised 61% of the accounts payable balance. As of December 31, 2018, three vendors comprised 37% of the accounts payable balance. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment: Property and equipment, summarized by major category, consist of the following as of December 31: 2019 2018 Machinery & equipment $ 5,635 $ 5,635 Right of use, building and lease 720 — Computer equipment & software 437 406 Office furniture & equipment 174 155 Leasehold improvements 43 43 Idle equipment 679 679 Total 7,688 6,918 Less accumulated depreciation (5,613) (3,846) Total property, plant & equipment, net $ 2,075 $ 3,072 |
Other Intangible Assets
Other Intangible Assets | 12 Months Ended |
Dec. 31, 2019 | |
Text Block [Abstract] | |
Other Intangible Assets | Other intangible assets: Other intangible assets, net, consisting of product rights and licenses are summarized as follows: December 31, 2019 Gross Carrying Accumulated Intangible Assets, Weighted average Product rights $ 6,050 $ (6,003) $ 47 0.61 BELBUCA license and distribution rights 45,000 (13,500) 31,500 3.77 Symproic license and distribution rights 30,636 (1,827) 28,809 4.40 Licenses 1,900 (1,900) — 0.30 Total intangible assets $ 83,586 $ (23,230) $ 60,356 December 31, 2018 Gross Carrying Accumulated Intangible Assets, Weighted average Product rights $ 6,050 $ (5,442) $ 608 1.08 BELBUCA license and distribution rights 45,000 (9,000) 36,000 7.65 Licenses 1,900 (1,805) 95 0.50 Total intangible assets $ 52,950 $ (16,247) $ 36,703 The Company incurred amortization expense on other intangible assets of approximately $7.0 million, $5.2 million and $5.4 million for the years ended December 31, 2019, 2018 and 2017, respectively. Estimated aggregate future amortization expenses for other intangible assets for each of the next five years and thereafter are as follows: Years ending December 31, 2020 $ 6,981 2021 6,935 2022 6,935 2023 6,935 2024 6,935 Thereafter 25,635 $ 60,356 |
License Agreements and Acquired
License Agreements and Acquired Product Rights | 12 Months Ended |
Dec. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
License Agreements and Acquired Product Rights | 8. License agreements and acquired product rights: On April 4, 2019 (the “Effective Date”), the Company and Shionogi Inc. (“Shionogi”) entered into an exclusive license agreement (the “License Agreement”) for the commercialization of Symproic in the United States including Puerto Rico (the “Territory”) for opioid-induced constipation in adult patients with chronic non-cancer pain (the “Field”). Pursuant to the terms of the License Agreement, the Company paid Shionogi a $20 million up-front payment on the Effective Date and paid Shionogi a $10 million payment on the six-month anniversary of the Effective Date (October 4, 2019), and quarterly, tiered royalty payments on potential sales of Symproic in the Territory that range from 8.5% to 17.5% (plus an additional 1% of net sales on a pass-through basis to a third party licensor of Shionogi) of net sales based on volume of net sales and whether Symproic is being sold as an authorized generic. Assets acquired as part of the License Agreement include: intellectual property, inventory, trademarks and tradenames. The Company and Shionogi have made customary representations and warranties and have agreed to certain other customary covenants, including confidentiality, limitation of liability and indemnity provisions. Either party may terminate the License Agreement for cause if the other party materially breaches or defaults in the performance of its obligations. Unless earlier terminated, the License Agreement will continue in effect until the expiration of the Company’s royalty obligations, as defined. Upon expiration of the License Agreement, all licenses granted to Company for Symproic in the Field and in the Territory survive and become fully-paid, royalty-free, perpetual and irrevocable. The Company and Shionogi have also entered into a customary supply agreement under which Shionogi will supply Symproic to the Company at cost plus an agreed upon markup for an initial term of up to two years. In the event the Company elects to source Symproic from a third party supplier, Shionogi would continue to supply the Company with naldemedine tosylate for use in Symproic at cost plus such agreed upon markup for the duration of the License Agreement. The Company and Shionogi also entered into a customary transition services and distribution agreement under which Shionogi will continue to perform certain sales, distribution and related activities and commercialization and administrative services on the Company’s behalf until June 30, 2019 pursuant to the transition services and distribution agreement (the “Transition Date”) (during which time, in lieu of paying royalties and cost-plus supply, distribution and transitional services during this period, Shionogi will retain 35% of the net sales of Symproic in the Territory and remit the remaining 65% of net sales to the Company) and certain other customary transitional services (if so requested by the Company), initially at no cost and thereafter, at a specified hourly rate for a term not to exceed three months from the Transition Date or the term of the Agreement. The Company and Shionogi have also entered into a Pharmacovigilance agreement that required ongoing cooperation on adverse event reporting for the duration of License Agreement. The Company accounted for the Symproic purchase as an asset acquisition under ASC 805-10-55-5b, which provides guidance for asset acquisitions. Under the guidance, if substantially all the acquisition is made up of one asset or several similar assets, then the acquisition is an asset acquisition. The Company believes that the licensing agreement and other assets acquired from Shionogi are similar and consider them all to be intangible assets. The total purchase price was allocated to the acquired asset based on their relative estimated fair values, as follows: Symproic license $ 30,000 Transaction expenses $ 636 Total value $ 30,636 Additionally, the Company also purchased from Shionogi $0.4 million of Symproic samples, which have been recorded in selling, general and administrative expenses in the accompanying consolidated statement of operations for year ended December 31, 2019. |
Business Combination and BELBUC
Business Combination and BELBUCA Acquisition | 12 Months Ended |
Dec. 31, 2019 | |
Business Combinations [Abstract] | |
Business Combination and BELBUCA Acquisition | Business combination and BELBUCA acquisition: On December 7, 2016, the Company and Endo Pharmaceuticals, ("Endo") entered into the Termination Agreement to terminate Endo’s licensing rights for BELBUCA. The transaction closed on January 6, 2017. At the closing date, the Company purchased from Endo the following net assets (the “net assets”): (i) current BELBUCA product inventory and work-in-progress, (ii) material manufacturing contracts related to BELBUCA, (iii) BELBUCA-related domain names and trademarks (including the BELBUCA trademark), (iv) BELBUCA -related manufacturing equipment, and (v) all pre-approval regulatory submissions, including any INDs and NDAs, regulatory approvals and post-approval regulatory submissions concerning BELBUCA. The BELBUCA acquisition was accounted for as a business combination in accordance with ASC No. 805, Business Combinations which, among other things, requires assets acquired and liabilities assumed to be measured at their acquisition date fair values. The following table summarizes the consideration paid to acquire BELBUCA and the estimated values of assets acquired and liabilities assumed in the accompanying consolidated balance sheet based on their fair values on January 6, 2017 (the date of the Endo Closing): Asset purchase price: Deferred cash consideration to Endo $ 7,536 Total asset purchase price $ 7,536 Estimated fair value of assets acquired: BELBUCA product inventory and work-in process $ 5,412 BELBUCA-related manufacturing equipment 432 License and distribution rights intangible assets 45,000 Deferred tax liability (15,972) Amount attributable to assets acquired $ 34,872 Bargain purchase gain $ (27,336) |
License Agreements
License Agreements | 12 Months Ended |
Dec. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
License Agreements | License agreements: Mylan license and supply agreement In 2006, the Company announced collaboration with Meda AB, (which was acquired by Mylan N.V. "Mylan") to develop and commercialize BEMA Fentanyl (marketed as BREAKYL™ in Europe). Under terms of the agreement, the Company granted Mylan rights to the European development and commercialization of BREAKYL. Mylan managed the regulatory submission in Europe that led to approval in October 2010. In 2009, the Company amended the European agreement to provide Mylan the worldwide rights to ONSOLIS, except for South Korea and Taiwan. The sales royalties to be received by the Company are the same for all territories as agreed to for Europe. The Company received cumulative payments totaling $2.2 million, $1.8 million and $2.2 million, all which related to royalties based on product purchased by Mylan of BREAKYL. Such amounts are recorded as contract revenue in the accompanying consolidated statement of operations for the years ended December 31, 2019, 2018 and 2017, respectively. TTY license and supply agreement In 2010, the Company announced a license and supply agreement with TTY Biopharm Co., Ltd. (“TTY”) for the exclusive rights to develop and commercialize BEMA Fentanyl in the Republic of China, Taiwan. In 2013, the Company announced the regulatory approval of BEMA Fentanyl in Taiwan, where the product is now marketed under the brand name PAINKYL. The Company receives an ongoing royalty based on net sales. The term of the agreement with TTY is for the period from October 2010 until the date fifteen years after first commercial sale unless the agreement is extended in writing or earlier terminated as provided for in the agreement. The Company received cumulative payments totaling $1.2 million, $1.5 million and $1.2 million, all which related to royalties based on product purchased in Taiwan by TTY of PAINKYL. Such amounts are recorded as contract revenue in the accompanying consolidated statement of operations for the years ended December 31, 2019, 2018 and 2017, respectively. |
Notes Payable
Notes Payable | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Notes Payable | Notes payable: On February 21, 2017, the Company entered into a term loan agreement (the “Term Loan Agreement”) with CRG Servicing LLC, ("CRG"), as administrative agent and collateral agent, and the lenders named in the Term Loan Agreement (the “Lenders”). Pursuant to the Term Loan Agreement, the Company borrowed $45.0 million from the Lenders as of the Closing Date. On December 26, 2017, the Company elected to receive the second draw for gross proceeds of $15.0 million. On May 23, 2019, the Company entered into a Loan Agreement (the “Loan Agreement”) with Biopharma Credit plc (“Pharmakon”), for a senior secured credit facility consisting of a term loan of $60 million (the “Term Loan”), with the ability to draw an additional $20 million within twelve months of the closing date. The Loan Agreement replaced the Company’s existing Term Loan Agreement (the “Original Loan Agreement”) with CRG. The Company utilized $60 million of the initial loan proceeds under the Loan Agreement, plus an additional $1.8 million to repay all of the outstanding loan balance owed by the Company under the Original Loan Agreement. The Company also used existing cash on hand to pay a $5.6 million backend facility fee to CRG. Upon the repayment of all amounts owed by the Company under the CRG Original Loan Agreement, all commitments to CRG were terminated and all security interests granted by the Company and its subsidiary guarantors under the CRG Original Loan Agreement were released. During the year ended December 31, 2019, the Company expensed one-time costs of $5.2 million in unamortized deferred loan fees, $3.9 million in unamortized warrant discount costs and $2.8 million in loan prepayment fees and realized losses arising out of the CRG Term Loan and recorded as interest expense in the accompanying consolidated statement of operations. The new facility carries a 72-month term with interest only payments on the term loan for the first 36 months. The Term Loan will mature in May 2025 and bears an interest rate of 7.5% plus the LIBOR rate (LIBOR effective rate as of October 1, 2019 was 2.09%). The Term Loan is subject to mandatory prepayment provisions that require prepayment upon change of control. The obligations under the Loan Agreement are guaranteed by the Company’s subsidiaries and are secured by a first priority security interest in and a lien on substantially all of the assets of the Company and the subsidiary guarantors, subject to certain exceptions. The following table represents future maturities of the notes payable obligation as of December 31, 2019: 2020 $ — 2021 — 2022 13,846 2023 18,462 2024 18,462 2025 9,230 Total maturities $ 60,000 Unamortized discount and loan costs (1,432) Total notes payable obligation $ 58,568 |
Net Sales by Product
Net Sales by Product | 12 Months Ended |
Dec. 31, 2019 | |
Segment Reporting [Abstract] | |
Net Sales by Product | Net sales by product: The Company operates in a single industry engaging in the commercialization of pharmaceutical products for chronic conditions. Accordingly, the Company’s business is classified as a single reportable segment. The following table presents net sales by product for each of the years ended December 31 (in thousands): Year ended December 31, 2019 2018 2017 BELBUCA $ 97,538 $ 45,988 $ 26,980 % of net product sales 90.4 % 89.5 % 77.3 % Symproic 8,061 $ — $ — % of net product sales 7.5 % — % — % BUNAVAIL 2,289 5,422 7,942 % of net product sales 2.1 % 10.5 % 22.7 % Net product sales $ 107,888 $ 51,410 $ 34,922 In March 2020 the company announced it will discontinue marketing of BUNAVAIL in 2020. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income taxes:On December 22, 2017, the United States enacted major tax reform legislation, Public Law No. 115-97, commonly referred to as the Tax Cuts and Jobs Act (or 2017 Tax Act). The 2017 Tax Act, among other changes, lowers the general corporate income tax rate to 21% for tax years beginning after December 31, 2017, transitions U.S. international taxation from a worldwide tax system to a territorial system and provides for a one-time transition tax on the mandatory deemed repatriation of cumulative foreign earnings as of December 31, 2017, which is not applicable to the Company. The Company has calculated the impact of the 2017 Tax Act in its income tax provision during the years ended December 31, 2019, 2018 and 2017 based on the provisions of the Act. Reconciliation of the Federal statutory income tax rate of 21% to the effective rate is as follows: 2019 2018 2017 Federal statutory income (benefit) tax rate 21.00 % 21.00 % (34.00) % 2017 Tax Act, net deferred tax remeasurement — — (626.73) State taxes, net of federal benefit (0.18) (0.11) (2.01) Stock compensation (5.39) (4.74) (5.18) Permanent differences-other (7.67) (1.33) (13.39) North Carolina tax rate change — — (32.75) Research and development (“R&D”) credit — — 5.54 Valuation release for bargain purchase gain — — (302.23) Other 1.71 (2.07) (1.36) Decrease (increase) in valuation allowance (9.44) (12.65) 709.88 0.03 % 0.10 % (302.23) % The tax effects of temporary differences and net operating losses that give rise to significant components of deferred tax assets and liabilities consist of the following: December 31, Deferred tax assets (liabilities) 2019 2018 Basis difference in equipment $(438) $(459) Basis difference in intangibles (5,356) (6,045) Accrued liabilities and other 3,942 2,246 R&D credit 10,980 10,980 Stock options 4,416 4,360 Net operating loss carry-forward 62,535 64,376 76,079 75,458 Less: valuation allowance (76,079) (75,458) $ — $ — The Company is required to reduce any deferred tax asset by a valuation allowance if, based on an assessment of positive and negative evidence, including estimates of future taxable income necessary to realize future deductible amounts, it is more likely than not (a likelihood of more than 50 percent) that some portion or all of the deferred tax assets will not be realized. As a result, the Company recorded a valuation allowance with respect to all of the Company’s deferred tax assets for the years ended December 31, 2019 and 2018. The Company has a federal net operating loss carry forward (“NOLs”) of approximately $271 million as of December 31, 2019. Under Section 382 and 383 of the Internal Revenue Code, if an ownership change occurs with respect to a “loss corporation”, as defined, there are annual limitations on the amount of the NOLs and other deductions, which are available to the Company. The Company has determined that the portion of the NOLs incurred prior to May 16, 2006 is subject to this limitation. As such, the use of these NOLs to offset taxable income is limited to approximately $1.5 million per year. The Company has state NOLs of approximately $261 million as of December 31, 2019. These state NOLs expire in various years through 2037 and certain state NOLs generated in 2018 have an indefinite carryforward period. The federal NOLs incurred through December 31, 2017 expire between 2024 and 2037. The federal NOL generated in 2018 has an indefinite carryforward life due to tax reform. Management has evaluated all other tax positions that could have a significant effect on the financial statements and determined that the Company has no uncertain income tax positions at December 31, 2019. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders’ equity: Common Stock On August 2, 2018, in connection with the Company’s 2018 Annual Meeting of Stockholders, the Company’s stockholders approved, among other matters, to amend the Company’s Certificate of Incorporation to increase the number of authorized shares of Common Stock from 75,000,000 to 125,000,000. On November 9, 2018, The Company filed a shelf registration statement (as amended on January 18, 2019) which registered up to $125 million of the Company’s securities for potential future issuance and such registration statement was effective on February 7, 2019. On July 25, 2019, in connection with the Company’s 2019 Annual Meeting of Stockholders, the Company’s stockholders approved, among other matters, an amendment to the Company’s Certificate of Incorporation to increase the number of authorized shares of Common Stock from 125,000,000 to 175,000,000. Preferred Stock and Series A Preferred The Company had authorized five “blank check” shares of $.001 par value convertible preferred stock. In the event of the Company’s liquidation, dissolution or winding up, holders of the Series A Preferred will receive a payment equal to $0.001 per share of Series A Preferred before any proceeds are distributed to the holders of common stock. After the payment of this preferential amount, and subject to the rights of holders of any class or series of capital stock hereafter created specifically ranking by its terms senior to the Series A Preferred, the holders of Series A Preferred will participate ratably in the distribution of any remaining assets with the common stock and any other class or series of our capital stock hereafter created that participates with the common stock in such distributions. At December 31, 2019, 2,093,155 shares of Series A Preferred were outstanding and 2,285,700 shares of “blank check” preferred stock remain authorized but undesignated. There were no conversions of Series A Preferred during the years ended December 31, 2019, 2018 or 2017. Series B Preferred stock financing In May of 2018, the Company closed on the sale of an aggregate of 5,000 shares of the Company’s authorized preferred stock that the Board of Directors of the Company has designated as Series B Non-Voting Convertible Preferred Stock, par value $0.001 per share (the “Series B Preferred Stock”) at a purchase price of $10,000 per share. Each share of Series B Preferred Stock is convertible into a number of shares of the Company’s common stock at a conversion price of $1.80 per share (subject to adjustment for stock splits and stock dividends as provided in the Certificate of Designation). At the time of closing the then outstanding shares of Series B Preferred Stock were convertible into an aggregate 27,777,778 shares of Common Stock. The Series B Preferred Stock does not contain any price-based anti-dilution protection. The Series B Preferred Stock is convertible at any time at the option of the holder, subject to certain limitations related to beneficial ownership. The Company has the right to deliver a notice to the holders of the Series B Preferred Stock to require conversion of the Series B Preferred Stock into Common Stock. Following an initial forced conversion of the Series B Preferred Stock, every ninety (90) days thereafter, the Company has the right to require the forced conversion of the still outstanding shares of Series B Preferred Stock, subject to certain limitations related to beneficial ownership. During the year ended December 31, 2019, a cumulative total of 2,482 shares of Series B Preferred Stock from various holders were converted into 13,788,888 shares of Common Stock. As of December 31, 2019, 618 shares of Series B Preferred Stock are outstanding. The Series B Preferred Stock issued in May 2018 contained a contingent beneficial conversion feature (“BCF”) that was recognized during the year ending December 31, 2018 upon the August 2018 stockholder approval, which eliminated the contingency. The Company evaluated its convertible preferred stock in accordance with provisions of ASC 815, Derivatives and Hedging, including consideration of embedded derivatives requiring bifurcation. The issuance of the Series B Preferred Stock generated a BCF, which arises when a debt or equity security is issued with an embedded conversion option that is beneficial to the investor or in the money at inception because the conversion option has an effective strike price that is less than the market price of the underlying stock at the commitment date. As a result, the intrinsic value of the conversion option, totaling $12.5 million, was recorded as an increase to additional paid-in capital, increasing net loss attributable to the Company Common stockholders. Public Offering On April 15, 2019 the Company completed an underwritten public offering by the Company and a selling stockholder of 12,000,000 shares of common stock at a public offering price of $5.00 per share. The gross proceeds from the Company’s portion of the offering (10,000,000 shares), before deducting the underwriter discounts and commission and other offering expenses, was $50.0 million. The net proceeds were $47.6 million. The gross proceeds to the selling stockholder were approximately $19.0 million, which includes shares sold pursuant to the underwriters’ exercise of their option to purchase an additional 1,800,000 shares of common stock at the public offering price. Stock options During the 2017 Annual Meeting of Stockholders, shareholders approved an amendment to the Company’s 2011 Equity Incentive Plan (the "2011 EIP"), to increase the number of shares of common stock authorized for issuance under the plan by 7,100,000 shares from 11,050,000 to 18,150,000. Additionally, during the 2019 Annual Meeting of Stockholders, shareholders approved the Company’s 2019 Stock Option and Incentive Plan (the “2019 Plan”), which reserves 14,000,000 shares of stock for issuance under the 2019 Plan. An additional 108,535 shares of Common Stock underlying options previously granted under the Company’s Amended and Restated 2001 Incentive Plan (the "2001 Plan), remain outstanding and exercisable as of December 31, 2019. The 2001 Plan expired in July 2011 and no new securities may be issued thereunder. An additional 4,369,045 shares of Common Stock underlying options previously granted under the 2011 EIP, remain outstanding and exercisable as of December 31, 2019. The 2011 Plan expired in July 2019 and no new securities may be issued thereunder. Options may be awarded during the ten During the years ended December 31, 2019, 2018 and 2017, Company employees, directors and affiliates exercised approximately 800,000, 400,000 and 200,000 stock options, respectively, with net proceeds to the Company of approximately $2.3 million, $0.7 million and $0.4 million, respectively. Stock option activity for the years ended December 31, 2019, 2018 and 2017 is as follows: Number of Weighted Average Aggregate Outstanding at January 1, 2017 3,468,991 $ 4.14 $ 0 Granted in 2017: Officers and Directors 83,658 $ 2.64 Others 873,017 1.96 Exercised (202,519) 2.17 Forfeitures (1,510,193) 5.13 Outstanding at December 31, 2017 2,712,954 $ 2.98 $ 1,190 Granted in 2018: Officers and Directors 1,249,817 $ 2.49 Others 1,299,360 2.60 Exercised (350,441) 2.00 Forfeitures (505,686) 3.48 Outstanding at December 31, 2018 4,406,004 $ 3.19 $ 4,172 Granted in 2019: Officers and Directors 1,228,109 $ 4.08 Others 1,160,643 4.51 Exercised (799,800) 2.90 Forfeitures (497,985) 2.03 Outstanding at December 31, 2019 5,496,971 $ 3.64 $ 15,455 Options outstanding at December 31, 2019 are as follows: Range of Exercise Prices Number Weighted Average Weighted Average Aggregate $1.00 – 5.00 5,011,678 8.38 $ 3.28 $5.01 – 10.00 415,537 6.81 $ 6.16 $10.01 – 15.00 38,756 5.15 $ 13.09 $15.01 – 20.00 31,000 4.74 $ 16.20 5,496,971 $ 15,455 Options exercisable at December 31, 2019 are as follows: Range of Exercise Prices Number Weighted Average Weighted Average Aggregate $1.00 – 5.00 1,284,107 7.46 $ 2.63 $5.01 – 10.00 269,861 5.14 $ 6.36 $10.01 – 15.00 38,756 5.15 $ 13.09 $15.01 – 20.00 31,000 4.74 $ 16.20 1,623,724 $ 4,712 The weighted average grant date fair value of options granted during the years ended December 31, 2019, 2018 and 2017 was $4.29, $1.57 and $1.46, respectively. There were no options granted during the years ended December 31, 2019, 2018 or 2017 whose exercise price was lower than the estimated market price of the stock at the grant date. Nonvested stock options as of December 31, 2019, and changes during the year then ended, are as follows: Nonvested Shares Shares Weighted Average Intrinsic Nonvested at January 1, 2019 2,763,833 Granted 2,388,752 Vested (995,589) Forfeited (283,749) Nonvested at December 31, 2019 3,873,247 $ 3.55 $ 10,743 As of December 31, 2019, there was approximately $3.4 million of unrecognized compensation cost related to unvested share-based compensation awards granted. These costs will be expensed over the next three years. Stock-based compensation During the year ended December 31, 2019, a total of 2,388,752 options to purchase Common Stock, with an aggregate fair market value of approximately $10.2 million, were granted to Company employees and directors. The options granted have a term of 10 years from the grant date and vest ratably between a one three Restricted stock units During the year ended December 31, 2019, 376,250 RSUs, were granted to members of the Company’s executive officers, board of directors, certain employees and a former officer, with a fair market value of approximately $1.7 million. The fair value of restricted units is determined using quoted market prices of the Common Stock and the number of shares expected to vest. Of the aforementioned RSU grants, 360,250 RSUs were issued under the 2011 Plan, and vest as following: (i) For executive officers, directors and employees, in equal installments over three years and (ii) for a former officer, the grant vested immediately in full April 2019. The remaining 16,000 RSUs were issued to a director under the 2019 Plan and vest in equal installments over three years. Restricted stock activity during the year ended December 31, 2019 was as follows: Number of Weighted Outstanding at January 1, 2018 2,166,102 $ 2.59 Granted: Executive officers 223,250 $ 4.44 Directors 106,000 $ 5.06 Employees 47,000 $ 4.77 Vested (806,661) $ 4.80 Forfeitures (87,132) $ 2.30 Outstanding at December 31, 2019 1,648,559 $ 3.86 Performance Long Term Incentive Plan In December 2012, the Company’s Board of Directors (the “Board”) approved the BDSI Performance Long Term Incentive Plan (“LTIP”). The LTIP is designed as an incentive for the Company’s senior management to generate revenue for the Company. The LTIP consists of RSUs (which are referred to in this context as Performance RSUs) which are rights to acquire shares of Common Stock. All Performance RSUs granted under the LTIP will be granted under the Company’s 2011 Equity Incentive Plan (as the same may be amended, supplemented or superseded from time to time) as “Performance Compensation Awards” under such plan. The participants in the LTIP are either named executive officers or senior officers of the Company. The term of the LTIP began with the Company’s fiscal year ended December 31, 2012 and ended during the fiscal year ending December 31, 2019. The total number of Performance RSUs covered by the LTIP was 1,078,000, of which 1,013,000 were awarded between in 2012 and 2015. No additional Performance RSUs were awarded between 2016 to 2019. The Performance RSUs under the LTIP vested each year over the 8-year term of the LTIP depending on the achievement of pre-defined annual revenue amounts by the Company, as reported in its Annual Report on Form 10-K. During the years ended 2019, 2018 and 2017, a total of 54,755, 31,036 and 9,958 RSUs vested, respectively. A cumulative total of 818,363 unvested LTIP shares were returned back to the 2019 Plan pool. Warrants: The Company has granted warrants to purchase shares of Common Stock. Warrants may be granted to affiliates in connection with certain agreements. During the year ended December 31, 2017, the Company granted warrants to purchase 84,986 shares of Common Stock at an exercise price of $3.53 per share to Midcap and its affiliates in connection with the Company’s extension agreement with Midcap. The warrants were valued using the Black-Scholes Model, which fair value is approximately $0.05 million. As of December 31, 2019, a cumulative of 84,986 warrants to Midcap and affiliates remain outstanding. In February 2017, the Company granted warrants to purchase 1,701,582 shares of Common Stock at an exercise price of $2.38 per share to CRG and certain of its affiliates in connection with the Company’s term loan agreement with CRG. The warrants were valued using the Black-Scholes Model, which fair value is approximately $4.5 million. In December 2017, the Company granted warrants to purchase 349,451 shares of Common Stock at an exercise price of $3.42 per share to CRG and certain of its affiliates in connection with the Company’s 2 nd tranche funding from its term loan agreement with CRG. The warrants were valued using the Black-Scholes Model, which fair value is approximately $1.5 million. As of December 31, 2019, a cumulative of 2,051,034 warrants to CRG and affiliates remain outstanding. |
Earnings per Common Share
Earnings per Common Share | 12 Months Ended |
Dec. 31, 2019 | |
Earnings Per Share [Abstract] | |
Earnings per Common Share | Earnings per common share: The following is a reconciliation of the numerators and denominators of the basic and diluted earnings per common share computations for the years ended December 31, 2019, 2018 and 2017. December 31, 2019 2018 2017 Basic: Net (loss) income $ (15,305) $ (33,867) $ 5,285 Less deemed dividend related to beneficial conversion feature on Series B Preferred Stock — (12,500) — Net (loss) income attributable to common stockholders, basic $ (15,305) $ (46,367) $ 5,285 Weighted average common shares outstanding 83,213,704 63,165,063 55,355,802 Basic (loss) income per common share $ (0.18) $ (0.73) $ 0.10 December 31, 2019 2018 2017 Diluted: Effect of dilutive securities: Net (loss) income attributable to common stockholders, diluted $ (15,305) $ (46,367) $ 5,285 Weighted average common shares outstanding 83,213,704 63,165,063 55,355,802 Effect of dilutive options and warrants — — 1,046,677 Diluted weighted average common shares outstanding 83,213,704 63,165,063 56,402,479 Diluted (loss) income per common share $ (0.18) $ (0.73) $ 0.09 Basic earnings per common share is calculated using the weighted average shares of Common Stock outstanding during the period. Common equivalent shares from stock options, RSUs, warrants and convertible preferred stock using the treasury stock method, are also included in the diluted per share calculations unless the effect of inclusion would be antidilutive. During the years ended December 31, 2019, 2018 and 2017, outstanding stock options, RSUs, warrants and convertible preferred stock of 11,116,195, 28,424,998 and 6,531,346, respectively, were not included in the computation of diluted earnings per common share, because to do so would have had an antidilutive effect because the outstanding exercise prices were greater than the average market price of the common shares during the relevant periods. Included in the year ended December 31, 2019 are the Series B shares as converted to common stock. The following is the total outstanding options, RSUs and warrants for the years ended December 31, 2019, 2018 and 2017, respectively. 2019 2018 2017 Options, RSUs, warrants and convertible preferred stock to purchase Common Stock 11,375,323 10,739,378 9,555,869 |
Retirement Plan
Retirement Plan | 12 Months Ended |
Dec. 31, 2019 | |
Retirement Benefits [Abstract] | |
Retirement Plan | Retirement plan:The Company sponsors a defined contribution retirement plan under Section 401(k) of the Internal Revenue Code. The plan covers all employees who meet certain eligibility and participation requirements. Participants may contribute up to 90% of their eligible earnings, as limited by law. The Company makes a matching contribution equal to 100% on the first 5% of participant contributions to the plan. The Company made contributions of approximately $1.0 million, $0.8 million and $0.5 million in years, 2019, 2018 and 2017. |
Commitments and contingencies
Commitments and contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and contingencies | Commitments and contingencies: Indemnifications The Company’s directors and officers are indemnified against costs and expenses related to stockholder and other claims (i.e., only actions taken in their capacity as officers and directors) that are not covered by the Company’s directors’ and officers’ insurance policy. This indemnification is ongoing and does not include a limit on the maximum potential future payments, nor are there any recourse provisions or collateral that may offset the cost. Post marketing requirements On October 5, 2017, the Company entered a subsequent party acknowledgement relating to its participation in the Opioid PMR Consortium (the “OPC”). The participants are member companies, collectively undertaking various observational and clinical studies to satisfy certain post-marketing requirements by the FDA as holders of a NDA for extended-release and long-acting opioid analgesics. As a requirement of joining the OPC, the Company was required to pay its share of the previous expenses incurred and funded by the existing member companies. The Company’s pro-rata share of such expenses totaled approximately $4.3 million, which was paid during the fourth quarter of 2018. Ongoing expenses are shared equally by the member companies and were paid monthly during 2019. Future ongoing expenses are anticipated to be paid monthly 2020 through 2023. Certain rights of CDC IV The Company and CDC IV are parties to the CDLA pursuant to which CDC IV has previously provided funds to the Company for the development of the Company’s ONSOLIS product. CDC IV is entitled to receive a mid-single digit royalty based on net sales of ONSOLIS, including minimum royalties of $375,000 per quarter beginning in the second full year following commercial launch. The royalty term expires upon the latter of expiration of the patent or generic entry into a particular country. In September 2007, in connection with CDC IV’s consent to the North American Mylan transaction, the Company, among other transactions with CDC IV, granted CDC IV a 1% royalty on net sales of the next BEMA product, which was BUNAVAIL. CDC IV’s right to the royalty shall immediately terminate at any time if annual net sales of BUNAVAIL equal less than $7.5 million in any calendar year following the third anniversary of initial launch of the product and CDC IV receives $0.02 million in three (3) consecutive quarters as payment for CDC IV’s one percent (1)% royalty during such calendar year. The Company records such royalties as costs of sales occur. In April 2016, CDC IV exercised its right pursuant to the Royalty Purchase and Amendment Agreement to exchange its royalty rights to the next BEMA product which was BUNAVAIL, in favor of royalty rights to the Substitute BEMA product which is BELBUCA (the CDC IV Option). Indivior (formerly RB Pharmaceuticals Ltd.) and Aquestive Therapeutics (formerly MonoSol Rx) The following disclosure regarding the Company’s ongoing litigations with Aquestive Therapeutics, Inc. (formerly MonoSol Rx, “Aquestive”) and Indivior PLC (formerly RB Pharmaceuticals Limited, “Indivior”) is intended to provide some background and an update on the matter as required by the rules of the SEC. Additional details regarding the past procedural history of the matter can be found in the Company’s previously filed periodic filings with the SEC. Litigation related to BUNAVAIL On October 29, 2013, Reckitt Benckiser, Inc., Indivior, and Aquestive (collectively, the “RB Plaintiffs”) filed an action against the Company relating to its BUNAVAIL product in the United States District Court for the Eastern District of North Carolina (“EDNC”) for alleged patent infringement. BUNAVAIL is a drug approved for the maintenance treatment of opioid dependence. The RB Plaintiffs claim that the formulation for BUNAVAIL, which has never been disclosed publicly, infringes its US Patent No. 8,475,832 (the “‘832 Patent”). On May 21, 2014, the Court granted the Company’s motion to dismiss. On January 22, 2014, Aquestive initiated an inter partes review (“IPR”) on U.S. Patent No. 7,579,019, the (“‘019 Patent”). The PTAB upheld all claims of the Company’s ‘019 Patent in 2015 and this decision was not appealed by Aquestive. On September 20, 2014, the Company proactively filed a declaratory judgment action in the United States District Court for the EDNC requesting the Court to make a determination that the Company’s BUNAVAIL product does not infringe the ‘832 Patent, US Patent No. 7,897,080 (the “‘080 Patent”) and US Patent No. 8,652,378 (the “‘378 Patent”). The Company invalidated the “‘080 Patent” in its entirety in an inter partes reexamination proceeding. The Company invalidated all relevant claims of the ‘832 Patent in an IPR proceeding. And, in an IPR proceeding for the ‘378 Patent, in its decision not to institute the IPR proceeding, the PTAB construed the claims of the ‘378 Patent narrowly. Shortly thereafter, by joint motion of the parties, the ‘378 Patent was subsequently removed from the action. On June 6, 2016, in an unrelated case in which Indivior and Aquestive asserted the ‘832 Patent against other parties, the Delaware District Court entered an order invalidating other claims in the ‘832 Patent. Indivior and Aquestive cross-appealed all adverse findings in that decision to the Court of Appeals for the Federal Circuit in Case No. 17-2587. The Company’s declaratory judgment action remains stayed pending the outcome of that cross-appeal by Indivior and Aquestive. On September 22, 2014, the RB Plaintiffs filed an action against the Company (and the Company’s commercial partner) relating to the Company’s BUNAVAIL product in the United States District Court for the District of New Jersey for alleged patent infringement. The RB Plaintiffs claim that BUNAVAIL, whose formulation and manufacturing processes have never been disclosed publicly, infringes its patent U.S. Patent No. 8,765,167 (the “‘167 Patent”). The Company believes this is an anticompetitive attempt by the RB Plaintiffs to distract the Company’s efforts from commercializing BUNAVAIL. On December 12, 2014, the Company filed a motion to transfer the case from New Jersey to North Carolina and a motion to dismiss the case against its commercial partner. On October 28, 2014, the Company filed multiple IPR petitions on certain claims of the ‘167 Patent. The USPTO instituted three of the four IPR petitions. The PTAB upheld the claims and denied collateral estoppel applied to the PTAB decisions in March 2016. The Company appealed to Court of Appeals for the Federal Circuit. The USPTO intervened with respect to whether collateral estoppel applied to the PTAB. On June 19, 2018, the Company filed a motion to remand the case for further consideration by the PTAB in view of intervening authority. On July 31, 2018, the Federal Circuit vacated the decisions, and remanded the ‘167 Patent IPRs for further consideration on the merits. On February 7, 2019, the PTAB issued three decisions on remand purporting to deny institution of the three previously instituted IPRs of the ‘167 patent. On March 11, 2019, the Company timely appealed the PTAB decisions on remand to U.S. Court of Appeal for the Federal Circuit. On March 20, 2019, Aquestive and Indivior moved to dismiss the appeal, and the Company opposed that motion. On August 29, 2019, a three-judge panel of the Court of Appeals for the Federal Circuit granted the motion and dismissed the Company’s appeal. On September 30, 2019, the Company filed a petition for an en banc rehearing of the order dismissing the Company’s appeal by the full Federal Circuit Court of Appeals. On January 13, 2020, by the Court of Appeals for the Federal Circuit denied BDSI’s petition for en banc rehearing of the dismissal of BDSI’s appeal relating to inter partes review proceedings on the ’167 patent. BDSI intends to appeal the decision dismissing BDSI’s appeal to the U.S. Supreme Court. Litigation related to BELBUCA On January 13, 2017, Aquestive filed a complaint in the United States District Court for the District of New Jersey alleging BELBUCA infringes the ‘167 Patent. In lieu of answering the complaint, the Company filed motions to dismiss the complaint and, in the alternative, to transfer the case to the EDNC. On July 25, 2017, the New Jersey Court administratively terminated the case pending the parties submission of a joint stipulation of transfer because the District of New Jersey was an inappropriate venue. This case was later transferred to the Delaware District Court. On October 31, 2017, the Company filed motions to dismiss the complaint and, in the alternative, to transfer the case to the EDNC. On October 16, 2018, denying the motion to dismiss as moot, the Delaware District Court granted the Company’s motion to transfer the case to the EDNC. On November 20, 2018, the Company moved the EDNC to dismiss the complaint for patent infringement for failure to state a claim for relief. On August 6, 2019, the EDNC granted the Company’s motion to dismiss, and dismissed the complaint without prejudice. On or about November 11, 2019, Aquestive refiled a complaint in the EDNC against the Company alleging that BELBUCA infringes the ‘167 Patent. The Company strongly refutes as without merit Aquestive’s assertion of patent infringement and will vigorously defend the lawsuit. Teva Pharmaceuticals USA (formerly Actavis) On February 8, 2016, the Company received a notice relating to a Paragraph IV certification from Teva Pharmaceuticals USA, or (formerly Actavis, “Teva”) seeking to find invalid three Orange Book listed patents relating specifically to BUNAVAIL. The Paragraph IV certification related to an ANDA filed by Teva with the FDA for a generic formulation of BUNAVAIL. The patents subject to Teva’s certification were the ‘019 Patent, U.S. Patent No. 8,147,866 (the “‘866 Patent”) and 8,703,177 (the “‘177 Patent”). On March 18, 2016, the Company asserted three different patents against Teva, the ‘019 Patent, the ‘866 Patent, and the ‘177 Patent. Teva did not raise non-infringement positions about the ‘019 and the ‘866 Patents in its Paragraph IV certification. Teva did raise a non-infringement position on the ‘177 Patent but the Company asserted in its complaint that Teva infringed the ‘177 Patent either literally or under the doctrine of equivalents. On December 20, 2016 the USPTO issued U.S. Patent No. 9,522,188 (the “‘188 Patent””), and this patent was properly listed in the Orange Book as covering the BUNAVAIL product. On February 23, 2017 Teva sent a Paragraph IV certification adding the 9,522,188 to its ANDA. An amended Complaint was filed, adding the ‘188 Patent to the litigation. On January 31, 2017, the Company received a notice relating to a Paragraph IV certification from Teva relating to Teva’s ANDA on additional strengths of BUNAVAIL and on March 16, 2017, the Company brought suit against Teva and its parent company on these additional strengths. On June 20, 2017, the Court entered orders staying both BUNAVAIL suits at the request of the parties. On May 23, 2017, the USPTO issued U.S. Patent 9,655,843 (the “‘843 Patent”) relating to the BEMA technology, and this patent was properly listed in the Orange Book as covering the BUNAVAIL product. Finally, on October 12, 2017, the Company announced that it had entered into a settlement agreement with Teva that resolved the Company’s BUNAVAIL patent litigation against Teva pending in the U.S. District Court for the District of Delaware. As part of the Settlement Agreement, which is subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice, the Company has entered into a non-exclusive license agreement with Teva that permits Teva to first begin selling its generic version of BUNAVAIL in the U.S. on July 23, 2028 or earlier under certain circumstances. Other terms of the agreement are confidential. The Company received notices regarding Paragraph IV certifications from Teva on November 8, 2016, November 10, 2016, and December 22, 2016, seeking to find invalid two Orange Book listed patents relating specifically to BELBUCA. The Paragraph IV certifications relate to three ANDAs filed by Teva with the FDA for a generic formulation of BELBUCA. The patents subject to Teva’s certification were the ‘019 Patent and the ‘866 Patent. The Company filed complaints in Delaware against Teva on December 22, 2016 and February 3, 2017 in which it asserted against Teva the ‘019 Patent and the ‘866 Patent. Teva did not contest infringement of the claims of the ‘019 Patent and did not contest infringement of the claims of the ‘866 Patent. The ‘019 Patent had already been the subject of an unrelated IPR before the USPTO under which the Company prevailed, and all claims of the ‘019 Patent survived. Aquestive’s request for rehearing of the final IPR decision regarding the ‘019 Patent was denied by the USPTO on December 19, 2016. Aquestive did not file a timely appeal at the Federal Circuit. On May 23, 2017, the USPTO issued U.S. Patent 9,655,843 (the “‘843 Patent”) relating to the BEMA technology, and this patent was properly listed in the Orange Book as covering the BELBUCA product. On August 28, 2017, the Court entered orders staying both BELBUCA suits at the request of the parties. In February 2018, the Company announced that it had entered into a settlement agreement with Teva that resolved the Company’s BELBUCA patent litigation against Teva pending in the U.S. District Court for the District of Delaware. As part of the settlement agreement, which is subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice, the Company has granted Teva a non-exclusive license (for which the Company will receive no current or future payments) that permits Teva to first begin selling the generic version of the Company’s BELBUCA product in the U.S. on January 23, 2027 or earlier under certain circumstances (including, for example, upon (i) the delisting of the patents-in-suit from the U.S. FDA Orange Book, (ii) the granting of a license by us to a third party to launch another generic form of BELBUCA at a date prior to January 23, 2027, or (iii) the occurrence of certain conditions regarding BELBUCA market share). Other terms of the Agreement are confidential. Alvogen On September 7, 2018, the Company filed a complaint for patent infringement in the Federal District Court of Delaware in Wilmington against Alvogen Pb Research & Development LLC, Alvogen Malta Operations Ltd., Alvogen Pine Brook LLC, Alvogen, Incorporated, and Alvogen Group, Incorporated (collectively, “Alvogen”), asserting that Alvogen infringes the Company’s Orange Book listed patents for BELBUCA®, including U.S. Patent Nos. 8,147,866 and 9,655,843, both expiring in July of 2027, and U.S. Patent No. 9,901,539, expiring in December of 2032. This complaint follows receipt by the Company on July 30, 2018 of a Paragraph IV Patent Certification from Alvogen stating that Alvogen had filed an ANDA with the FDA for a generic version of BELBUCA® Buccal Film (75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg and 900 mcg). Because the Company initiated a patent infringement suit to defend the patents identified in the Paragraph IV notice within 45 days after receipt of the Paragraph IV Certification, the FDA is prevented from approving the ANDA until the earlier of 30 months or a decision in the case that each of the patents is not infringed or invalid. Alvogen’s notice letter also does not provide any information on the timing or approval status of its ANDA. In its Paragraph IV Certification, Alvogen does not contest infringement of at least several independent claims of each of the ’866, ’843, and ’539 patents. Rather, Alvogen advances only invalidly arguments for these independent claims. The Company believes that it will be able to prevail on its claims of infringement of these patents, particularly as Alvogen does not contest infringement of certain claims of each patent. Additionally, as the Company has done in the past, it intends to vigorously defend its intellectual property against assertions of invalidity. Each of the three patents carry a presumption of validity, which can only be overcome by clear and convincing evidence. 2018 Arkansas Opioid Litigation On March 15, 2018, the State of Arkansas, and certain counties and cities in that State, filed an action in the Circuit Court of Arkansas, Crittenden County against multiple manufacturers, distributors, retailers, and prescribers of opioid analgesics, including the Company. The Company was served with the complaint on April 27, 2018. The complaint specifically alleged that it licensed its branded fentanyl buccal soluble film ONSOLIS to Collegium, and Collegium is also named as a defendant in the lawsuit. ONSOLIS is not presently sold in the United States and the license agreement with Collegium was terminated prior to Collegium launching ONSOLIS in the United States. Therefore, on June 28, 2018, the Company moved to dismiss the case against it and most recently, on July 6, 2018, the plaintiffs filed a notice to voluntarily dismiss us from the Arkansas case, without prejudice. Chemo Research, S.L On March 1, 2019, the Company filed a complaint for patent infringement in the Federal District Court of Delaware in Wilmington against Chemo Research, S.L., Insud Pharma S.L., IntelGenx Corp., and IntelGenx Technologies Corp. (collectively, “Defendants”), asserting that the Defendants infringe its Orange Book listed patents for BELBUCA, including U.S. Patent Nos. 8,147,866 and 9,655,843, both expiring in July of 2027, and U.S. Patent No. 9,901,539 expiring December of 2032. This complaint follows a receipt by the Company on January 31, 2019, of a Notice Letter from Chemo Research S.L. stating that it has filed with the FDA an ANDA containing a Paragraph IV Patent Certification, for a generic version of BELBUCA Buccal Film in strengths 75 mcg, 150 mcg, 300 mcg, 450 mcg, and 900 mcg. Because the Company initiated a patent infringement suit to defend the patents identified in the Notice Letter within 45 days after receipt, the FDA is prevented from approving the ANDA until the earlier of 30 months or a decision in the case that each of the patents is not infringed or invalid. Chemo Research S.L.’s Notice Letter also does not provide any information on the timing or approval status of its ANDA. On March 15, 2019, the Company filed a complaint against the Defendants in New Jersey asserting the same claims for patent infringement made in the Delaware lawsuit. On April 19, 2019, Defendants filed an answer to the Delaware complaint wherein they denied infringement of the ‘866, ‘843 and ‘539 patents and asserted counterclaims seeking declaratory relief concerning the alleged invalidity and non-infringement of such patents. On April 25, 2019, the Company voluntarily dismissed the New Jersey lawsuit given Defendants’ consent to jurisdiction in Delaware. The Company believes that it will be able to prevail in this lawsuit. As it has done in the past, the Company intends to vigorously defend its intellectual property against assertions of invalidity. Derivative Litigation On July 2, 2018, the Company filed a Schedule 14A Proxy Statement (the “Proxy”) with the U.S. Securities and Exchange Commission (the “SEC”) in connection with its 2018 Annual Meeting. Proposals 1 and 2 of the Proxy sought stockholder approval to amend the Company’s Certificate of Incorporation by deleting Article TWELFTH of the Company’s Certificate of Incorporation in its entirety and replacing it with a new Article TWELFTH that, among other things (i) provided for the declassification of the Company’s Board in phases, with the full declassification to be achieved in 2020 (the “Declassification Amendment”) and (ii) changed the voting standard for the uncontested election of directors to the Board from a plurality standard to the majority of votes cast standard as set forth in the bylaws of the Company (the “Election Amendment” and together with the “Declassification Amendment”, the “Amendments”). On August 2, 2018, the Company held the 2018 Annual Meeting, at which time the stockholders voted on the Amendments. Following the 2018 Annual Meeting, based on consultation with the Company’s advisors, the Company determined that the Amendments had been adopted by the requisite vote of stockholders and effected the Amendments by filing a Certificate of Amendment to the Certificate of Incorporation with the Secretary of State of the State of Delaware on August 6, 2018. On September 11, 2019, two purported stockholders of the Company filed a putative class action against the Company and our directors in the Court of Chancery of the State of Delaware, captioned Drachman v. BioDelivery Sciences International, Inc., et al., C.A. No. 2019-0728-AGB (Del. Ch.) (the “Complaint”). The Complaint alleges that the Amendments did not receive the requisite vote of stockholders at the 2018 Annual Meeting and asserts claims for violation of the Delaware General Corporation Law, breach of fiduciary duties, and declaratory judgment. The Complaint seeks, inter alia, a declaration that the Amendments were not validly approved and invalidation of the Amendments, including altering the one-year terms of all directors duly elected at the 2018 and 2019 Annual Meetings to three-year terms. The Complaint also seeks costs and disbursements, including attorneys’ fees. The Company will respond to the complaint by the December 6, 2019 deadline set by the Court and defend against it vigorously. On November 5, 2019, the Board determined that ratifying the declassification of the Board and the change in the voting standard as set forth in the Amendments, as well as ratifying the filing and effectiveness of the Amendments, is in the best interests of the Company and its stockholders. The Board thus approved resolutions ratifying such acts and the filing and effectiveness of the Amendments under Section 204 of the Delaware General Corporation Law. The Company will submit the ratification to its stockholders for their adoption in accordance with Section 204 at its 2020 Annual Meeting. |
Selected Quarterly Results (Una
Selected Quarterly Results (Unaudited) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Results (Unaudited) | SELECTED QUARTERLY RESULTS (UNAUDITED) The following table sets forth certain quarterly financial data for the periods indicated (in thousands, except per share data): Quarter Ended March 31, June 30, September 30, December 31, 2019 Revenue $ 19,769 $ 29,677 $ 30,306 $ 31,637 Gross profit 15,717 24,754 24,956 24,372 Income (loss) from operations (1,272) 2,799 1,596 613 Net income (loss) (3,833) (11,130) 354 (696) Basic loss per share (0.05) (0.13) — — Diluted loss per share (0.05) (0.13) — — Quarter Ended March 31, June 30, September 30, December 31, 2018 Revenue $ 11,281 $ 12,175 $ 14,156 $ 18,028 Gross profit 7,866 7,609 10,377 14,005 Loss from operations (8,123) (7,266) (3,811) (4,448) Net loss (10,709) (9,770) (18,880) (7,008) Basic loss per share (0.18) (0.16) (0.29) (0.13) Diluted loss per share (0.18) (0.16) (0.29) (0.13) Quarter Ended March 31, June 30, September 30, December 31, 2017 Revenue $ 29,478 $ 8,744 $ 11,253 $ 12,510 Gross profit 23,833 4,573 6,808 7,275 Income (loss) from operations 7,903 (12,987) (10,045) (14,291) Net income (loss) 48,325 (14,879) (11,951) (16,210) Basic income (loss) per share 0.89 (0.27) (0.21) (0.31) Diluted income (loss) per share 0.87 (0.27) (0.21) (0.30) |
Schedule II - Valuation and Qua
Schedule II - Valuation and Qualifying Accounts and Reserves | 12 Months Ended |
Dec. 31, 2019 | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts [Abstract] | |
Valuation and Qualifying Accounts and Reserves | SCHEDULE II – VALUATION AND QUALIFYING ACCOUNTS AND RESERVES Balance at Charged Charged to Deductions Balance at (In thousands) Description Valuation allowance for deferred tax assets Year ended December 31, 2019: $ 75,458 $ 1,235 $ — $ — $ 76,693 Year ended December 31, 2018: $ 71,515 $ 3,943 $ — $ — $ 75,458 Year ended December 31, 2017: $ 109,030 $ (37,515) $ — $ — $ 71,515 Allowance for rebates Year ended December 31, 2019: $ 12,261 $ 81,217 $ 1,664 $ (65,801) $ 29,341 Year ended December 31, 2018: $ 5,648 $ 37,070 $ 813 $ (31,270) $ 12,261 Year ended December 31, 2017: $ 3,842 $ 17,236 $ (132) $ (15,298) $ 5,648 Allowance for price adjustments and chargebacks Year ended December 31, 2019: $ 4,018 $ 29,552 $ 1 $ (26,647) $ 6,924 Year ended December 31, 2018: $ 3,925 $ 13,033 $ — $ (12,940) $ 4,018 Year ended December 31, 2017: $ 602 $ 6,738 $ (3) $ (3,412) $ 3,925 Allowance for inventory obsolescence Year ended December 31, 2019: $ 187 $ 149 $ — $ (92) $ 244 Year ended December 31, 2018: $ 243 $ (56) $ — $ — $ 187 Year ended December 31, 2017: $ — $ 243 $ — $ — $ 243 |
Nature of Business and Summar_2
Nature of Business and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Organization | Organization BioDelivery Sciences International, Inc. and subsidiaries (the “Company”) was incorporated in the State of Indiana on January 6, 1997 and reincorporated as a Delaware corporation in 2002. The Company’s subsidiaries are Arius Pharmaceuticals, Inc., a Delaware corporation (“Arius One”) and Arius Two, Inc., a Delaware corporation (“Arius Two”), each of which are wholly-owned. The Company is a rapidly growing specialty pharmaceutical company dedicated to patients living with chronic pain and associated conditions. The Company has built a portfolio of products that includes utilizing its novel and proprietary BioErodible MucoAdhesive, or BEMA, drug-delivery technology to develop and commercialize new applications of proven therapies aimed at addressing important unmet medical needs. The Company commercializes in the U.S. using its own sales force while working in partnership with third parties to commercialize its products outside the U.S. As used herein, the Company’s common stock, par value $0.001 per share, is referred to as the “Common Stock” and the Company’s preferred stock, par value $0.001 per share, is referred to as the “Preferred Stock”. |
Principles of consolidation | Principles of consolidation The consolidated financial statements include the accounts of the Company, Arius One and Arius Two. All significant inter-company balances and transactions have been eliminated. |
Use of estimates in financial statements | Use of estimates in financial statements The preparation of the accompanying consolidated financial statements requires management to make 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 made by the Company include: revenue recognition associated with 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. |
Certain risks, concentrations and uncertainties | Certain risks, concentrations and uncertainties The Company relies on certain materials used in its development and third-party manufacturing processes, most of which are procured from three contract manufacturers and four active pharmaceutical ingredient (“API”) suppliers for BELBUCA, Symproic and BUNAVAIL ® . The Company purchases its pharmaceutical ingredients pursuant to long-term supply agreements with a limited number of suppliers. The failure of a supplier, including a subcontractor, to deliver on schedule could delay or interrupt the development or commercialization process and thereby adversely affect the Company’s operating results. In addition, a disruption in the commercial supply of or a significant increase in the cost of the API from any of these sources could have a material adverse effect on the Company’s BELBUCA and Symproic business, which would affect the Company’s financial position and results of operations. In 2019, the Company utilized only one contract manufacturer to create the BELBUCA and BUNAVAIL laminates and a second contract manufacturer to package the laminates into final product. The Company utilizes only one contract manufacturer to create the Symproic tablets and only one contract manufacturer to package the tablets into final product. Although the Company has long term supply agreements with these two vendors, any problems or regulatory issues at either of these vendors could create significant BELBUCA and Symproic supply delays. Amounts due to these vendors represented approximately 30.3% and 6.3% of total accounts payable as of December 31, 2019 and 2018, respectively. In 2019, the Company sold its BELBUCA, Symproic and BUNAVAIL products primarily to large national wholesalers, which in turn may resell the products to smaller or regional wholesalers, retail pharmacies, chain drug stores, government agencies and other third parties. The following table lists the Company’s customers that individually comprise greater than 10% of total accounts receivable: December 31, Customers 2019 2018 Customer A 42 % 47 % Customer B 35 % 22 % Customer C 18 % 25 % Total 95 % 94 % These three customers accounted for 94%, 92% and 92% of total annual sales during the years ended December 31, 2019, 2018 and 2017 respectively. In March 2020 the Company announced that it will discontinue marketing of BUNAVAIL in 2020. |
Cash | Cash The Company places cash on deposit with financial institutions in the United States. The Federal Deposit Insurance Corporation covers $0.25 million for substantially all depository accounts. As of December 31, 2019, the Company had approximately $65.1 million, which exceeded these insured limits. As of December 31, 2018, the Company had approximately $43.6 million, which exceeded these insured limits. |
Accounts receivable | Accounts receivable The Company offers wholesale distributors a prompt payment discount if they make payments within a prescribed number of days. 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 $0.9 million and $0.3 million as of December 31, 2019 and 2018, respectively. The Company performs ongoing credit evaluations and does not require collateral. As appropriate, the Company establishes provisions for potential credit losses. There were no allowances for doubtful accounts as of December 31, 2019 or 2018. 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. |
Inventory | 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 method and specifically allocated to remaining inventory. Inventory consists of raw materials, work in process and finished goods. Raw materials include amounts of active pharmaceutical ingredient for a product to be manufactured, work in process includes the bulk inventory of laminate (the Company’s drug delivery film) 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 more than the expected net realizable value and inventory that is more than expected demand based upon projected product sales. The Company recorded $0.4 million and $0.2 million in reserves for inventory obsolescence as of December 31, 2019 and 2018, respectively. The 2019 reserve includes an additional $0.2 million associated with the announced discontinuation of marketing of BUNAVAIL. Inventory is composed of the following at December 31: 2019 2018 Raw Materials & Supplies $ 624 $ 645 Work-in-process 6,198 2,093 Finished Goods 4,874 2,855 Finished Goods Reserve (384) (187) Total Inventories $ 11,312 $ 5,406 |
Property and equipment | Property and equipment The Company records property and equipment at cost less accumulated depreciation, which is computed on a straight-line basis over its estimated useful lives, generally 3 to 10 years. The Company evaluates the carrying value of equipment when events or changes in circumstances indicate the related carrying amount may not be recoverable. In connection with the discontinuation of the marketing of BUNAVAIL, the company recorded an additional $1.5 million of depreciation related to certain equipment used in the production of BUNAVAIL. The Company has certain manufacturing equipment that isn’t currently in production, which has been deemed idle. There was no impairment of equipment recorded during the year ended December 31, 2019 or 2018. |
Intangibles and goodwill | Intangibles and goodwill The Company reviews intangible assets with finite lives (“other intangible assets”) for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company uses an estimate of the undiscounted cash flows over the remaining life of its other intangible assets, or related group of assets where applicable, in measuring whether the assets to be held and used will be realizable. In the event of impairment, the Company would discount the future cash flows using its then estimated incremental borrowing rate to estimate the amount of the impairment. There were no impairment charges recognized on finite lived intangibles in 2019, 2018 or 2017. Intangible assets with finite useful lives are amortized over the estimated useful lives as follows: Estimated Licenses 15 years BELBUCA license and distribution rights 10 years Symproic license and distribution rights 12 years U.S. product rights 8-12 years EU product rights 7-11 years 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 2019, 2018 or 2017. |
Revenue recognition | Revenue recognition The Company recognizes revenue in accordance with ASC, Topic 606, Revenue from Contracts with Customers ("ASC606"), which was adopted on January 1, 2018, using the modified retrospective transition method. Product sales The Company recognizes revenue on product sales when control of the promised goods is transferred to its customers in an amount that reflects the consideration expected to be received in exchange for transferring those goods. The Company accounts for a contract when it has approval and commitment from both parties, the rights of the parties are identified, payment terms are identified, the contract has commercial substance and collectability of consideration is probable. When determining whether the customer has obtained control of the goods, the Company considers any future performance obligations. Generally, there is no post-shipment obligation on product sold. Performance obligations A performance obligation is a promise in a contract to transfer a distinct good or service to the customer. A contract’s transaction price is allocated to each distinct performance obligation and recognized as revenue when, or as, the performance obligation is satisfied. The majority of the Company’s product sales contracts have a single performance obligation as the promise to transfer the individual goods is not separately identifiable from other promises in the contracts and, therefore, not distinct. The Company’s performance obligations are satisfied at a point in time. The multiple performance obligations are not allocated based off of the obligations but based off of standard selling price. Adjustments to product sales The Company recognizes product sales net of estimated allowances for rebates, price adjustments, returns, chargebacks, vouchers and prompt payment discounts. A significant majority of the Company’s adjustments to gross product revenues are the result of accruals for its commercial contracts, retail consumer subsidy programs, and Medicaid and Medicare rebates. 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. In addition, the Company receives daily information from the wholesalers regarding their sales and actual on hand inventory levels of the Company’s products. This enables the Company to execute accurate provisioning procedures. Product returns -Consistent with industry practice, the Company offers contractual return rights that allow its customers to return the products within an 18-month period that begins six months prior to and ends twelve months after expiration of the products. In connection with the March 2020 announcement of the discontinuation of marketing of BUNAVAIL, the 2019 results include a one-time reserve of $2.2 million for additional BUNAVAIL product returns. Rebates - The liability for government program rebates is calculated based on historical and current rebate redemption and utilization rates contractually submitted by each program’s administrator. Price adjustments and chargebacks- The Company’s estimates of price adjustments and chargebacks are based on its estimated mix of sales to various third-party payers, which are entitled either contractually or statutorily to discounts from the Company’s listed prices of its products. If the sales mix to third-party payers is different from the Company’s estimates, the Company may be required to pay higher or lower total price adjustments and/or chargebacks than it had estimated, and such differences may be significant. The Company, from time to time, offers certain promotional product-related incentives to its customers. During 2019, the Company had voucher programs for BELBUCA Symproic and BUNAVAIL whereby the Company offers a point-of-sale subsidy to retail consumers. The Company estimates its liabilities for these voucher programs based on the current utilization and historical redemption rates as reported to the Company by a third-party claims processing organization. The Company accounts for the costs of these special promotional programs as price adjustments, which are a reduction of gross revenue. Prompt payment discounts-The Company typically offers its wholesale customers a prompt payment discount of 2% as an incentive to remit payments within a prescribed number of days after the invoice date depending on the customer and the products purchased. Gross to net accruals-A significant majority of the Company’s gross to net adjustments to gross product revenues are the result of accruals for its voucher program and rebates related to Medicare Part D, Part D Coverage Gap, Medicaid and commercial contracts, with most of those programs having an accrual to payment cycle of anywhere from one to three months. In addition to this relatively short accrual to payment cycle, the Company receives daily information from the wholesalers regarding their sales of the Company’s products and actual on hand inventory levels of its products. This enables the Company to execute accurate provisioning procedures. Consistent with the pharmaceutical industry, the accrual to payment cycle for returns is longer and can take several years depending on the expiration of the related products. 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 license agreements that are described in note 7, of which these revenues are classified as contract revenue. |
Cost of sales | Cost of sales In 2019, cost of sales included the direct costs attributable to the production of BELBUCA, Symproic and BUNAVAIL. It included raw materials, production costs at the Company’s three contract manufacturing sites, quality testing directly related to the products, inventory adjustment charges, and depreciation on equipment that the Company had purchased to produce BELBUCA and BUNAVAIL. It also includes any batches not meeting specifications and raw material yield losses. Yield losses and batches not meeting specifications are expensed as incurred. Cost of sales is recognized when sold to the wholesaler from our distribution center. For BREAKYL and PAINKYL (the Company’s out-licensed breakthrough cancer pain therapies), cost of sales includes all costs related to creating the product at the Company’s contract manufacturing location in Germany. The Company’s contract manufacturer bills the Company for the final product, which includes materials, direct labor costs, and certain overhead costs as outlined in applicable supply agreements. Cost of sales also includes royalty expenses that the Company owes to third parties. |
Research and development expenses | Research and development expenses Research and development expenses have historically consisted of product development expenses incurred in identifying, developing and testing product candidates. Product development expenses consisted 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; regulatory costs; costs of contract research and manufacturing of inventory used in testing and clinical trials. As of January 1, 2019, the Company has focused entirely on commercialized products rather than research and development. As such, there were no expenses incurred in research and development during the year ended December 31, 2019. Research and development expense for the years ended December 31, 2018 and 2017 totaled $4.9 million and $13.0 million, respectively. |
Advertising | Advertising Advertising costs, which include promotional expenses and the cost of placebo samples, are expensed as incurred. Advertising expenses were $10.8 million, $4.5 million and $3.8 million for the years ended December 31, 2019, 2018 and 2017, respectively, and are included in selling, general and administrative expenses in the accompanying consolidated statements of operations. |
Shipping and handling costs | Shipping and handling costs Shipping and handling costs, which include expenses from our wholesalers, are expensed as incurred. Shipping and handling costs were $0.03 million, $0.02 million and $0.01 million for the years ended December 31, 2019, 2018 and 2017, respectively, and are included in selling, general and administrative expenses in the accompanying consolidated statements of operations. |
Stock-based compensation | 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: 2019 2018 2017 Expected price volatility 61.66%-64.10% 60.34%-68.77% 68.76%-78.79% Risk-free interest rate 1.36%-2.66% 2.05%-3.00% 1.77%-2.05% Weighted average expected life in years 6 years 6 years 6 years Dividend yield — — — |
Fair value of financial instruments | Fair Value of Financial Instruments The Company measures the fair value of instruments in accordance with GAAP which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. GAAP defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. GAAP also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The Company considers the carrying amount of its cash and cash equivalents to approximate fair value due to short-term nature of this instrument. GAAP describes three levels of inputs that may be used to measure fair value: Level 1 – quoted prices in active markets for identical assets or liabilities Level 2 – quoted prices for similar assets and liabilities in active markets or inputs that are observable Level 3 – inputs that are unobservable (for example cash flow modeling inputs based on assumptions) The following table summarizes the cash and cash equivalents measured at fair value on a recurring basis as of December 31, 2019: Level 1 Level 2 Level 3 Balance Cash and cash equivalents $ 63,888 — — $63,888 |
Nature of Business and Summar_3
Nature of Business and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Summary of Company's Customers Accounts Receivable | The following table lists the Company’s customers that individually comprise greater than 10% of total accounts receivable: December 31, Customers 2019 2018 Customer A 42 % 47 % Customer B 35 % 22 % Customer C 18 % 25 % Total 95 % 94 % |
Summary of Inventories | Inventory is composed of the following at December 31: 2019 2018 Raw Materials & Supplies $ 624 $ 645 Work-in-process 6,198 2,093 Finished Goods 4,874 2,855 Finished Goods Reserve (384) (187) Total Inventories $ 11,312 $ 5,406 |
Intangible Assets with Finite Useful Lives, Amortized Over Estimated Useful Lives | Intangible assets with finite useful lives are amortized over the estimated useful lives as follows: Estimated Licenses 15 years BELBUCA license and distribution rights 10 years Symproic license and distribution rights 12 years U.S. product rights 8-12 years EU product rights 7-11 years |
Black Scholes Options-Pricing Model, Assumptions | In applying the Black-Scholes options-pricing model, assumptions are as follows: 2019 2018 2017 Expected price volatility 61.66%-64.10% 60.34%-68.77% 68.76%-78.79% Risk-free interest rate 1.36%-2.66% 2.05%-3.00% 1.77%-2.05% Weighted average expected life in years 6 years 6 years 6 years Dividend yield — — — |
Fair Value, Assets Measured on Recurring and Nonrecurring Basis | The following table summarizes the cash and cash equivalents measured at fair value on a recurring basis as of December 31, 2019: Level 1 Level 2 Level 3 Balance Cash and cash equivalents $ 63,888 — — $63,888 Accounting Pronouncements adopted in 2019 In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842). The authoritative guidance significantly amends the current accounting for leases. Under the new provisions, all lessees will report a right-of-use asset and a liability for the obligation to make payments for all leases with the exception of those leases with a term of 12 months or less. All other leases will fall into one of two categories: (i) a financing lease or (ii) an operating lease. In July 2018, the FASB issued ASU No. 2018-10, Codification Improvements to Topic 842 (Leases) , which amends narrow aspects of the guidance issued in the amendments in ASU 2016-02, and ASU No. 2018-11, Leases (Topic 842): Targeted Improvements, which allows entities to recognize a cumulative-effect adjustment from the application of ASU 2016-02 to the opening balance of retained earnings in the period of adoption. Effective January 1, 2019, the Company adopted Topic 842 using the modified retrospective method as of January 1, 2019 and will not restate comparative periods. The Company elected the optional package of practical expedients, which allowed the Company to not reassess: (i) whether any expired or existing contracts are considered or contain leases; (ii) lease classification for any expired or existing leases; and (iii) initial direct costs for any existing leases. The new standard also allows entities to make certain policy elections, including a policy to not separate lease and non-lease components, which the Company did not elect for its facility and office equipment lease. Refer to footnote three “Leases” for further information. Accounting Pronouncements not yet adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses of Financial Instruments; in November 2018 the FASB issued a subsequent amendment ASU No. 2018-19, Codi fication Improvements to Topic 326, Financial Instruments—Credit Losses; in April 2019 the FASB issued ASU No. 2019-04, Codification Improvements to Topic 326, Financial Instruments—Credit Losses. In May 2019 the FASB issued ASU No. 2019-05, Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief; and in November 2019 the FASB issued ASU No. 2019-11, Codification Improvements to Topic 326, Financial Instruments—Credit Losses. The new guidance changes the methodology for measuring credit losses on financial instruments and the timing of when such losses are recorded. In November 2019 the FASB issued ASU No. 2019-10, Financial Instruments—Credit Losses (Topic 326). This guidance is effective for fiscal years beginning after December 15, 2022 and early adoption is permitted. The Company is currently evaluating the timing and effect the new guidance will have on its consolidated financial statements. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement, which modifies the disclosure requirements on fair value measurements. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019 and early adoption is permitted. The Company is currently evaluating but does not expect the new guidance to have a material impact on its consolidated financial statements. In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606, which amends ASC 808 to clarify ASC 606 should apply in entirety to certain transactions between collaborative arrangement participants. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The Company is currently evaluating but does not expect the new guidance to have a material impact on its consolidated financial statements. In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740)— Simplifying the Accounting for Income Taxes, which is intended to simplify accounting for income taxes. It removes certain exceptions to the general principles in Topic 740 and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020 and early adoption is permitted. The Company is currently evaluating but does not expect the new guidance to have a material impact on its consolidated financial statements. |
Revenue from Contracts with C_2
Revenue from Contracts with Customers (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Revenue from Contract with Customer [Abstract] | |
Impact and cumulative effect of adoption of ASC 606 on condensed consolidated balance sheet, statement of operations and accounts receivables | The beginning and ending balances of the Company’s accounts receivables with customers from contracts during the periods presented is as follows (in thousands): Balance at Year ended December 31, Balance at December 31, Accounts receivable with customers $ 8,987 $ 4,640 $ 13,627 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Schedule of Adjustments for Adoption of ASC 842 | The impact of the adoption of Topic 842 on the accompanying consolidated balance sheet as of January 1, 2019 is as follows (in thousands): December 31, 2018 Adjustments Due to the Adoption of Topic 842 January 1, 2019 Right-of-use asset Lease liability Property and equipment, net $ 3,072 $ 939 $ — $ 4,011 Current liabilities $ 21,539 $ — $ 212 $ 21,751 Other long-term liabilities $ 5,600 $ — $ 822 $ 6,422 |
Lease, Cost | The components of lease expense were as follows: Twelve months ended December 31, 2019 2018 Lease Cost Operating lease cost Operating lease $ 328 $ 325 Variable lease costs $ 13 $ 2 Total lease cost $ 341 $ 327 Supplemental cash flow information related to leases were as follows: Twelve months ended December 31, 2019 2018 Other information Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ 351 $ 327 Twelve months ended December 31, 2019 2018 Lease term and discount rate Weighted-average remaining lease term operating leases 3.0 years 4.0 years Weighted-average discount rate operating leases 11.8 % 11.8 % |
Future Minimum Commitment on the Remaining Operating Lease | Future minimum lease payments under non-cancellable leases as of December 31, 2019 were as follows: Maturity of lease liabilities 2020 $360 2021 $370 2022 $219 Total lease payments $949 Less: Interest $(128) Present value of lease liabilities $821 |
Lease Assets and Liabilities | Components of Lease Assets and Liabilities December 31, 2019 Assets Property and equipment, net operating lease-right of use asset $ 720 Liabilities Current liabilities operating lease-current liability $ 281 Other long-term liabilities operating lease-noncurrent liability $ 540 Total lease liabilities $ 821 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Payables and Accruals [Abstract] | |
Summary of Components of Accounts Payable and Accrued Liabilities | The following table represents the components of accounts payable and accrued liabilities as of December 31: 2019 2018 Accounts payable $ 11,704 $ 3,166 Accrued rebates 28,528 12,261 Accrued compensation and benefits 5,545 3,814 Accrued acquisition costs — 318 Accrued returns 4,438 715 Accrued royalties 535 159 Accrued clinical trial costs — 464 Accrued regulatory fees 331 — Accrued legal 1,484 70 Accrued other 1,428 572 Total accounts payable and accrued expenses $ 53,993 $ 21,539 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Summarized Category of Fixed Assets | Property and equipment, summarized by major category, consist of the following as of December 31: 2019 2018 Machinery & equipment $ 5,635 $ 5,635 Right of use, building and lease 720 — Computer equipment & software 437 406 Office furniture & equipment 174 155 Leasehold improvements 43 43 Idle equipment 679 679 Total 7,688 6,918 Less accumulated depreciation (5,613) (3,846) Total property, plant & equipment, net $ 2,075 $ 3,072 |
Other Intangible Assets (Tables
Other Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Text Block [Abstract] | |
Summary of Other Intangible Assets Net Consisting of Product Rights and Licenses | Other intangible assets, net, consisting of product rights and licenses are summarized as follows: December 31, 2019 Gross Carrying Accumulated Intangible Assets, Weighted average Product rights $ 6,050 $ (6,003) $ 47 0.61 BELBUCA license and distribution rights 45,000 (13,500) 31,500 3.77 Symproic license and distribution rights 30,636 (1,827) 28,809 4.40 Licenses 1,900 (1,900) — 0.30 Total intangible assets $ 83,586 $ (23,230) $ 60,356 December 31, 2018 Gross Carrying Accumulated Intangible Assets, Weighted average Product rights $ 6,050 $ (5,442) $ 608 1.08 BELBUCA license and distribution rights 45,000 (9,000) 36,000 7.65 Licenses 1,900 (1,805) 95 0.50 Total intangible assets $ 52,950 $ (16,247) $ 36,703 |
Schedule Estimated Aggregate Future Amortization Expenses for Other Intangible Assets | Estimated aggregate future amortization expenses for other intangible assets for each of the next five years and thereafter are as follows: Years ending December 31, 2020 $ 6,981 2021 6,935 2022 6,935 2023 6,935 2024 6,935 Thereafter 25,635 $ 60,356 |
License Agreements and Acquir_2
License Agreements and Acquired Product Rights (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Allocation of Purchase Price of License Agreement | The total purchase price was allocated to the acquired asset based on their relative estimated fair values, as follows: Symproic license $ 30,000 Transaction expenses $ 636 Total value $ 30,636 |
Business Combination and BELB_2
Business Combination and BELBUCA Acquisition (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
BELBUCA | |
Summary of Asset Purchase Price and Estimated Values of Assets Acquired and Liabilities Assumed | The following table summarizes the consideration paid to acquire BELBUCA and the estimated values of assets acquired and liabilities assumed in the accompanying consolidated balance sheet based on their fair values on January 6, 2017 (the date of the Endo Closing): Asset purchase price: Deferred cash consideration to Endo $ 7,536 Total asset purchase price $ 7,536 Estimated fair value of assets acquired: BELBUCA product inventory and work-in process $ 5,412 BELBUCA-related manufacturing equipment 432 License and distribution rights intangible assets 45,000 Deferred tax liability (15,972) Amount attributable to assets acquired $ 34,872 Bargain purchase gain $ (27,336) |
Notes Payable (Tables)
Notes Payable (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Debt Disclosure [Abstract] | |
Future Maturities of the CRG Obligation | The following table represents future maturities of the notes payable obligation as of December 31, 2019: 2020 $ — 2021 — 2022 13,846 2023 18,462 2024 18,462 2025 9,230 Total maturities $ 60,000 Unamortized discount and loan costs (1,432) Total notes payable obligation $ 58,568 |
Net Sales by Product (Tables)
Net Sales by Product (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Segment Reporting [Abstract] | |
Summary of Net Sales by Product | The following table presents net sales by product for each of the years ended December 31 (in thousands): Year ended December 31, 2019 2018 2017 BELBUCA $ 97,538 $ 45,988 $ 26,980 % of net product sales 90.4 % 89.5 % 77.3 % Symproic 8,061 $ — $ — % of net product sales 7.5 % — % — % BUNAVAIL 2,289 5,422 7,942 % of net product sales 2.1 % 10.5 % 22.7 % Net product sales $ 107,888 $ 51,410 $ 34,922 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Reconciliation of Federal Statutory Income Tax Rate | Reconciliation of the Federal statutory income tax rate of 21% to the effective rate is as follows: 2019 2018 2017 Federal statutory income (benefit) tax rate 21.00 % 21.00 % (34.00) % 2017 Tax Act, net deferred tax remeasurement — — (626.73) State taxes, net of federal benefit (0.18) (0.11) (2.01) Stock compensation (5.39) (4.74) (5.18) Permanent differences-other (7.67) (1.33) (13.39) North Carolina tax rate change — — (32.75) Research and development (“R&D”) credit — — 5.54 Valuation release for bargain purchase gain — — (302.23) Other 1.71 (2.07) (1.36) Decrease (increase) in valuation allowance (9.44) (12.65) 709.88 0.03 % 0.10 % (302.23) % |
Significant Components of Deferred Tax Assets and Liabilities | The tax effects of temporary differences and net operating losses that give rise to significant components of deferred tax assets and liabilities consist of the following: December 31, Deferred tax assets (liabilities) 2019 2018 Basis difference in equipment $(438) $(459) Basis difference in intangibles (5,356) (6,045) Accrued liabilities and other 3,942 2,246 R&D credit 10,980 10,980 Stock options 4,416 4,360 Net operating loss carry-forward 62,535 64,376 76,079 75,458 Less: valuation allowance (76,079) (75,458) $ — $ — |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Summary of Stock Option Activity | Stock option activity for the years ended December 31, 2019, 2018 and 2017 is as follows: Number of Weighted Average Aggregate Outstanding at January 1, 2017 3,468,991 $ 4.14 $ 0 Granted in 2017: Officers and Directors 83,658 $ 2.64 Others 873,017 1.96 Exercised (202,519) 2.17 Forfeitures (1,510,193) 5.13 Outstanding at December 31, 2017 2,712,954 $ 2.98 $ 1,190 Granted in 2018: Officers and Directors 1,249,817 $ 2.49 Others 1,299,360 2.60 Exercised (350,441) 2.00 Forfeitures (505,686) 3.48 Outstanding at December 31, 2018 4,406,004 $ 3.19 $ 4,172 Granted in 2019: Officers and Directors 1,228,109 $ 4.08 Others 1,160,643 4.51 Exercised (799,800) 2.90 Forfeitures (497,985) 2.03 Outstanding at December 31, 2019 5,496,971 $ 3.64 $ 15,455 |
Summary of Stock Options Outstanding | Options outstanding at December 31, 2019 are as follows: Range of Exercise Prices Number Weighted Average Weighted Average Aggregate $1.00 – 5.00 5,011,678 8.38 $ 3.28 $5.01 – 10.00 415,537 6.81 $ 6.16 $10.01 – 15.00 38,756 5.15 $ 13.09 $15.01 – 20.00 31,000 4.74 $ 16.20 5,496,971 $ 15,455 |
Summary of Stock Options Exercisable | Options exercisable at December 31, 2019 are as follows: Range of Exercise Prices Number Weighted Average Weighted Average Aggregate $1.00 – 5.00 1,284,107 7.46 $ 2.63 $5.01 – 10.00 269,861 5.14 $ 6.36 $10.01 – 15.00 38,756 5.15 $ 13.09 $15.01 – 20.00 31,000 4.74 $ 16.20 1,623,724 $ 4,712 |
Summary of Non-Vested Stock Options | Nonvested stock options as of December 31, 2019, and changes during the year then ended, are as follows: Nonvested Shares Shares Weighted Average Intrinsic Nonvested at January 1, 2019 2,763,833 Granted 2,388,752 Vested (995,589) Forfeited (283,749) Nonvested at December 31, 2019 3,873,247 $ 3.55 $ 10,743 |
Summary of Restricted Stock Activity | Restricted stock activity during the year ended December 31, 2019 was as follows: Number of Weighted Outstanding at January 1, 2018 2,166,102 $ 2.59 Granted: Executive officers 223,250 $ 4.44 Directors 106,000 $ 5.06 Employees 47,000 $ 4.77 Vested (806,661) $ 4.80 Forfeitures (87,132) $ 2.30 Outstanding at December 31, 2019 1,648,559 $ 3.86 |
Earnings per Common Share (Tabl
Earnings per Common Share (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Earnings Per Share [Abstract] | |
Reconciliation of Numerators and Denominators of Basic and Diluted Earnings Per Common Share Computations | The following is a reconciliation of the numerators and denominators of the basic and diluted earnings per common share computations for the years ended December 31, 2019, 2018 and 2017. December 31, 2019 2018 2017 Basic: Net (loss) income $ (15,305) $ (33,867) $ 5,285 Less deemed dividend related to beneficial conversion feature on Series B Preferred Stock — (12,500) — Net (loss) income attributable to common stockholders, basic $ (15,305) $ (46,367) $ 5,285 Weighted average common shares outstanding 83,213,704 63,165,063 55,355,802 Basic (loss) income per common share $ (0.18) $ (0.73) $ 0.10 December 31, 2019 2018 2017 Diluted: Effect of dilutive securities: Net (loss) income attributable to common stockholders, diluted $ (15,305) $ (46,367) $ 5,285 Weighted average common shares outstanding 83,213,704 63,165,063 55,355,802 Effect of dilutive options and warrants — — 1,046,677 Diluted weighted average common shares outstanding 83,213,704 63,165,063 56,402,479 Diluted (loss) income per common share $ (0.18) $ (0.73) $ 0.09 |
Schedule of Total Outstanding Options, RSUs and Warrants | The following is the total outstanding options, RSUs and warrants for the years ended December 31, 2019, 2018 and 2017, respectively. 2019 2018 2017 Options, RSUs, warrants and convertible preferred stock to purchase Common Stock 11,375,323 10,739,378 9,555,869 |
Commitments and contingencies (
Commitments and contingencies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Future Minimum Commitment on the Remaining Operating Lease | Future minimum lease payments under non-cancellable leases as of December 31, 2019 were as follows: Maturity of lease liabilities 2020 $360 2021 $370 2022 $219 Total lease payments $949 Less: Interest $(128) Present value of lease liabilities $821 |
Selected Quarterly Results (U_2
Selected Quarterly Results (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Results | The following table sets forth certain quarterly financial data for the periods indicated (in thousands, except per share data): Quarter Ended March 31, June 30, September 30, December 31, 2019 Revenue $ 19,769 $ 29,677 $ 30,306 $ 31,637 Gross profit 15,717 24,754 24,956 24,372 Income (loss) from operations (1,272) 2,799 1,596 613 Net income (loss) (3,833) (11,130) 354 (696) Basic loss per share (0.05) (0.13) — — Diluted loss per share (0.05) (0.13) — — Quarter Ended March 31, June 30, September 30, December 31, 2018 Revenue $ 11,281 $ 12,175 $ 14,156 $ 18,028 Gross profit 7,866 7,609 10,377 14,005 Loss from operations (8,123) (7,266) (3,811) (4,448) Net loss (10,709) (9,770) (18,880) (7,008) Basic loss per share (0.18) (0.16) (0.29) (0.13) Diluted loss per share (0.18) (0.16) (0.29) (0.13) Quarter Ended March 31, June 30, September 30, December 31, 2017 Revenue $ 29,478 $ 8,744 $ 11,253 $ 12,510 Gross profit 23,833 4,573 6,808 7,275 Income (loss) from operations 7,903 (12,987) (10,045) (14,291) Net income (loss) 48,325 (14,879) (11,951) (16,210) Basic income (loss) per share 0.89 (0.27) (0.21) (0.31) Diluted income (loss) per share 0.87 (0.27) (0.21) (0.30) |
Nature of Business and Summar_4
Nature of Business and Summary of Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended | ||
Dec. 31, 2019USD ($)CustomerManufacturer$ / shares | Dec. 31, 2018USD ($)$ / shares | Dec. 31, 2017USD ($) | |
Basis Of Presentation [Line Items] | |||
Common stock, par value (in usd per share) | $ / shares | $ 0.001 | $ 0.001 | |
Preferred stock, par value (in usd per share) | $ / shares | $ 0.001 | $ 0.001 | |
Number of contract manufacturers | Manufacturer | 3 | ||
Percentage of amount due to vendors payable | 30.30% | 6.30% | |
Number of customers | Customer | 3 | ||
FDIC insurance coverage | $ 250,000 | ||
Net deposit amount exceeding specified amount under FDIC | $ 65,100,000 | $ 43,600,000 | |
Discount for prompt payment | 2.00% | ||
Percentage of prompt payment discount, accrued | 100.00% | ||
Allowance for prompt payment of discount | $ 900,000 | 300,000 | |
Allowance for doubtful accounts receivable | 0 | 0 | |
Inventory reserve | 384,000 | 187,000 | |
Depreciation | 300,000 | 1,000,000 | $ 700,000 |
Impairment loss | 0 | 78,000 | 0 |
Impairment charges recognized on finite lived intangibles assets | 0 | 0 | 0 |
Goodwill impairment charges | $ 0 | 0 | 0 |
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 | ||
Research and development | $ 0 | 4,903,000 | 13,040,000 |
Advertising expenses | 10,800,000 | 4,500,000 | 3,800,000 |
Shipping and handling costs | $ 21,590,000 | $ 15,783,000 | $ 19,496,000 |
Sales Revenue, Net | Customer Concentration Risk | |||
Basis Of Presentation [Line Items] | |||
Percentage of amount due to major vendors accounts payable | 94.00% | 92.00% | 92.00% |
BUNAVAIL | |||
Basis Of Presentation [Line Items] | |||
Inventory reserve | $ 200,000 | ||
Depreciation | 1,500,000 | ||
Impairment loss | 0 | $ 0 | $ 0 |
Reserve liability, product returns | 2,200,000 | ||
Shipping and Handling | |||
Basis Of Presentation [Line Items] | |||
Shipping and handling costs | $ 30,000 | $ 20,000 | $ 10,000 |
Minimum | |||
Basis Of Presentation [Line Items] | |||
Estimated useful lives of equipment | 3 years | ||
Maximum | |||
Basis Of Presentation [Line Items] | |||
Estimated useful lives of equipment | 10 years |
Nature of Business and Summar_5
Nature of Business and Summary of Significant Accounting Policies - Summary of Company's Customers Accounts Receivable (Detail) - Customer Concentration Risk | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Accounts Receivable | |||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||||
Percentage of amount due from major customers accounts receivable | 95.00% | 94.00% | |||
Accounts Receivable | Customer A | |||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||||
Percentage of amount due from major customers accounts receivable | 42.00% | 47.00% | |||
Accounts Receivable | Customer B | |||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||||
Percentage of amount due from major customers accounts receivable | 35.00% | 22.00% | |||
Accounts Receivable | Customer C | |||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||||
Percentage of amount due from major customers accounts receivable | 18.00% | 25.00% | |||
Revenue Benchmark | |||||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||||
Percentage of amount due from major customers accounts receivable | 94.00% | 92.00% | 92.00% |
Nature of Business and Summar_6
Nature of Business and Summary of Significant Accounting Policies - Summary of Inventories (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw Materials & Supplies | $ 624 | $ 645 |
Work-in-process | 6,198 | 2,093 |
Finished Goods | 4,874 | 2,855 |
Finished Goods Reserve | (384) | (187) |
Total Inventories | $ 11,312 | $ 5,406 |
Nature of Business and Summar_7
Nature of Business and Summary of Significant Accounting Policies - Intangible Assets with Finite Useful Lives, Amortized Over Estimated Useful Lives (Detail) | 12 Months Ended |
Dec. 31, 2019 | |
Licenses | |
Finite-Lived Intangible Assets [Line Items] | |
Estimated useful lives | 15 years |
BELBUCA License and Distribution Rights | |
Finite-Lived Intangible Assets [Line Items] | |
Estimated useful lives | 10 years |
Symproic License | |
Finite-Lived Intangible Assets [Line Items] | |
Estimated useful lives | 12 years |
U.S. Product Rights | Minimum | |
Finite-Lived Intangible Assets [Line Items] | |
Estimated useful lives | 8 years |
U.S. Product Rights | Maximum | |
Finite-Lived Intangible Assets [Line Items] | |
Estimated useful lives | 12 years |
EU Product Rights | Minimum | |
Finite-Lived Intangible Assets [Line Items] | |
Estimated useful lives | 7 years |
EU Product Rights | Maximum | |
Finite-Lived Intangible Assets [Line Items] | |
Estimated useful lives | 11 years |
Nature of Business and Summar_8
Nature of Business and Summary of Significant Accounting Policies - Black Scholes Options-Pricing Model, Assumptions (Detail) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted average expected life in years | 6 years | 6 years | 6 years |
Dividend yield | 0.00% | 0.00% | 0.00% |
Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected price volatility | 61.66% | 60.34% | 68.76% |
Risk-free interest rate | 1.36% | 2.05% | 1.77% |
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected price volatility | 64.10% | 68.77% | 78.79% |
Risk-free interest rate | 2.66% | 3.00% | 2.05% |
Nature of Business and Summar_9
Nature of Business and Summary of Significant Accounting Policies - Fair Value of Cash and Cash Equivalents (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Accounting Policies [Abstract] | ||
Cash | $ 63,888 | $ 43,822 |
Cash and Cash Equivalents, Fair Value Disclosure | $ 63,888 |
Revenue from Contracts with C_3
Revenue from Contracts with Customers (Detail) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Jan. 01, 2018 | |
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Accounts receivable with customers | $ 38,790 | $ 13,627 | ||
Changes in accounts receivable with customers | $ 25,163 | $ 4,640 | $ 5,884 | |
Accounting Standards Update 2014-09 | ||||
Revenue, Initial Application Period Cumulative Effect Transition [Line Items] | ||||
Accounts receivable with customers | $ 8,987 |
Leases - Impact of the Adoption
Leases - Impact of the Adoption of Topic 842 (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Property and equipment, net | $ 2,075 | $ 4,011 | $ 3,072 |
Total current liabilities | 53,993 | 21,751 | 21,539 |
Other long-term liabilities | $ 580 | 6,422 | $ 5,600 |
Accounting Standards Update 2016-02 | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Property and equipment, net | 939 | ||
Total current liabilities | 212 | ||
Other long-term liabilities | $ 822 |
Leases - Schedule of Components
Leases - Schedule of Components of Lease Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Leases [Abstract] | ||
Operating Lease, Cost | $ 328 | $ 325 |
Variable Lease, Cost | 13 | 2 |
Lease, Cost | $ 341 | $ 327 |
Leases - Schedule of Supplement
Leases - Schedule of Supplemental Cash Flow Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Leases [Abstract] | ||
Operating Lease, Payments | $ 351 | $ 327 |
Operating Lease, Weighted Average Remaining Lease Term | 3 years | 4 years |
Operating Lease, Weighted Average Discount Rate, Percent | 11.80% | 11.80% |
Leases - Schedule of Future Min
Leases - Schedule of Future Minimum Lease Payments (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Leases [Abstract] | |
2020 | $ 360 |
2021 | 370 |
2022 | 219 |
Total lease payments | 949 |
Less: Interest | (128) |
Present value of lease liabilities | $ 821 |
Leases - Components of Lease As
Leases - Components of Lease Assets and Liabilities (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Assets [Abstract] | |
Property and equipment, net Operating lease-right of use asset | $ 720 |
Liabilities [Abstract] | |
Current liabilities Operating lease-current liability | 281 |
Other long-term liabilities Operating lease-noncurrent liability | 540 |
Total lease liabilities | $ 821 |
Liquidity (Detail)
Liquidity (Detail) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Liquidity And Managements Plans [Abstract] | ||||
Cash | $ 63,888 | $ 43,822 | ||
Net cash flows from operating activities | 11,100 | |||
Stockholders' equity | $ 69,764 | $ 29,742 | $ 8,877 | $ (17,665) |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Liabilities - Summary of Components (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Payables and Accruals [Abstract] | ||
Accounts payable | $ 11,704 | $ 3,166 |
Accrued rebates | 28,528 | 12,261 |
Accrued compensation and benefits | 5,545 | 3,814 |
Accrued acquisition costs | 0 | 318 |
Accrued returns | 4,438 | 715 |
Accrued royalties | 535 | 159 |
Accrued clinical trial costs | 0 | 464 |
Accrued regulatory fees | 331 | 0 |
Accrued legal | 1,484 | 70 |
Accrued other | 1,428 | 572 |
Total accounts payable and accrued expenses | $ 53,993 | $ 21,539 |
Accounts payable and Accrued _4
Accounts payable and Accrued Liabilities - Additional Information (Detail) - Vendor | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Accounts Payable And Accrued Expenses [Line Items] | ||
Number of vendors | 3 | 3 |
Accounts Payable | Supplier Concentration Risk | ||
Accounts Payable And Accrued Expenses [Line Items] | ||
Percentage of amount due to major vendors accounts payable | 61.00% | 37.00% |
Property and Equipment (Detail)
Property and Equipment (Detail) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Jan. 01, 2019 | |
Property, Plant and Equipment [Line Items] | ||||
Property, plant & equipment, gross | $ 6,918 | |||
Total property, plant, equipment, and ROU assets | $ 7,688 | |||
Less accumulated depreciation | (3,846) | |||
Less accumulated depreciation | (5,613) | |||
Total property, plant & equipment, net | 2,075 | 3,072 | $ 4,011 | |
Total property, plant & equipment, net | 2,075 | |||
Depreciation | 300 | 1,000 | $ 700 | |
BUNAVAIL | ||||
Property, Plant and Equipment [Line Items] | ||||
Depreciation | 1,500 | |||
Machinery and Equipment | ||||
Property, Plant and Equipment [Line Items] | ||||
Property, plant & equipment, gross | 5,635 | 5,635 | ||
Building | ||||
Property, Plant and Equipment [Line Items] | ||||
Right of use, building and lease | 720 | |||
Computer Equipment and Software | ||||
Property, Plant and Equipment [Line Items] | ||||
Property, plant & equipment, gross | 437 | 406 | ||
Office Furniture and Equipment | ||||
Property, Plant and Equipment [Line Items] | ||||
Property, plant & equipment, gross | 174 | 155 | ||
Leasehold Improvements | ||||
Property, Plant and Equipment [Line Items] | ||||
Property, plant & equipment, gross | 43 | 43 | ||
Idle Equipment | ||||
Property, Plant and Equipment [Line Items] | ||||
Property, plant & equipment, gross | $ 679 | $ 679 |
Other Intangible Assets - Summa
Other Intangible Assets - Summary of Other Intangible Assets Net (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | $ 83,586 | $ 52,950 |
Accumulated Amortization | (23,230) | (16,247) |
Intangible assets, net | 60,356 | 36,703 |
Product Rights | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 6,050 | 6,050 |
Accumulated Amortization | (6,003) | (5,442) |
Intangible assets, net | 47 | 608 |
License and Distribution Rights | BELBUCA | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 45,000 | 45,000 |
Accumulated Amortization | (13,500) | (9,000) |
Intangible assets, net | 31,500 | 36,000 |
License and Distribution Rights | Symproic | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 30,636 | |
Accumulated Amortization | (1,827) | |
Intangible assets, net | 28,809 | |
Licenses | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 1,900 | 1,900 |
Accumulated Amortization | (1,900) | (1,805) |
Intangible assets, net | $ 0 | $ 95 |
Weighted average useful life | 15 years | |
Weighted Average | Product Rights | ||
Finite-Lived Intangible Assets [Line Items] | ||
Weighted average useful life | 7 months 9 days | 1 year 29 days |
Weighted Average | License and Distribution Rights | BELBUCA | ||
Finite-Lived Intangible Assets [Line Items] | ||
Weighted average useful life | 3 years 9 months 7 days | 7 years 7 months 24 days |
Weighted Average | License and Distribution Rights | Symproic | ||
Finite-Lived Intangible Assets [Line Items] | ||
Weighted average useful life | 4 years 4 months 24 days | |
Weighted Average | Licenses | ||
Finite-Lived Intangible Assets [Line Items] | ||
Weighted average useful life | 3 months 18 days | 6 months |
Other Intangible Assets - Addit
Other Intangible Assets - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |||
Amortization expense on other intangible assets | $ 6,981 | $ 5,157 | $ 5,425 |
Other Intangible Assets - Sched
Other Intangible Assets - Schedule of Future Amortization (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
2020 | $ 6,981 | |
2021 | 6,935 | |
2022 | 6,935 | |
2023 | 6,935 | |
2024 | 6,935 | |
Thereafter | 25,635 | |
Intangible assets, net | $ 60,356 | $ 36,703 |
License Agreements and Acquir_3
License Agreements and Acquired Product Rights - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||
Jun. 30, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Apr. 04, 2019 | |
Finite-Lived Intangible Assets [Line Items] | |||||
Percent of sales remaining | 65.00% | ||||
Selling, general and administrative | $ 86,063 | $ 58,602 | $ 58,869 | ||
Symproic License | Shiongi License And Supply Agreement | |||||
Finite-Lived Intangible Assets [Line Items] | |||||
Upfront first installment payment | $ 20,000 | ||||
Upfront installment hence to be made | $ 10,000 | ||||
Percent of sales retained by supplier for a specified duration | 35.00% | ||||
Selling, general and administrative | $ 400 | ||||
Symproic License | Shiongi License And Supply Agreement | Additional Royalty As A Percentage | |||||
Finite-Lived Intangible Assets [Line Items] | |||||
Percentage of amount due from major customers accounts receivable | 1.00% | ||||
Symproic License | Shiongi License And Supply Agreement | Royalty Agreement Terms | Minimum | |||||
Finite-Lived Intangible Assets [Line Items] | |||||
Percentage of amount due from major customers accounts receivable | 8.50% | ||||
Symproic License | Shiongi License And Supply Agreement | Royalty Agreement Terms | Maximum | |||||
Finite-Lived Intangible Assets [Line Items] | |||||
Percentage of amount due from major customers accounts receivable | 17.50% |
License Agreements and Acquir_4
License Agreements and Acquired Product Rights (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Finite-Lived Intangible Assets [Line Items] | ||
Finite-Lived Intangible Assets, Net | $ 60,356 | $ 36,703 |
Shiongi License And Supply Agreement | ||
Finite-Lived Intangible Assets [Line Items] | ||
Finite-Lived Intangible Assets, Net | 30,636 | |
Shiongi License And Supply Agreement | Symproic License | ||
Finite-Lived Intangible Assets [Line Items] | ||
Finite-Lived Intangible Assets, Net | 30,000 | |
Shiongi License And Supply Agreement | Transaction Expense | ||
Finite-Lived Intangible Assets [Line Items] | ||
Finite-Lived Intangible Assets, Net | $ 636 |
Business Combination and BELB_3
Business Combination and BELBUCA Acquisition (Detail) - USD ($) $ in Thousands | Jan. 06, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Asset purchase price: | ||||
Deferred cash consideration to Endo | $ 30,685 | $ 1,951 | $ 5,853 | |
Estimated fair value of assets acquired: | ||||
Bargain purchase gain | $ 0 | $ 0 | $ (27,336) | |
BELBUCA | ||||
Asset purchase price: | ||||
Deferred cash consideration to Endo | $ 7,536 | |||
Total asset purchase price | 7,536 | |||
Estimated fair value of assets acquired: | ||||
BELBUCA product inventory and work-in process | 5,412 | |||
BELBUCA-related manufacturing equipment | 432 | |||
License and distribution rights intangible assets | 45,000 | |||
Deferred tax liability | (15,972) | |||
Amount attributable to assets acquired | 34,872 | |||
Bargain purchase gain | $ (27,336) |
License Agreements (Detail)
License Agreements (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Mylan License and Supply Agreement | |||
Other License Agreements And Acquired Product Rights [Line Items] | |||
Milestone payment received | $ 2.2 | $ 1.8 | $ 2.2 |
TTY License and Supply Agreement | |||
Other License Agreements And Acquired Product Rights [Line Items] | |||
Milestone payment received | $ 1.2 | $ 1.5 | $ 1.2 |
Term of the agreement | 15 years |
Notes Payable - Additional Info
Notes Payable - Additional Information (Detail) - USD ($) | May 23, 2019 | Dec. 26, 2017 | Dec. 31, 2019 | Feb. 21, 2017 |
Debt Instrument [Line Items] | ||||
Loan agreement interest only term | 36 months | |||
Bio Pharma Credit Plc | ||||
Debt Instrument [Line Items] | ||||
Maximum borrowing capacity | $ 60,000,000 | |||
Additional facility that can be obtained | 20,000,000 | |||
Debt instrument, face amount | 60,000,000 | |||
Additional borrowing of face amount | 1,800,000 | |||
Bio Pharma Credit Plc | LIBOR | ||||
Debt Instrument [Line Items] | ||||
Loan agreement term | 72 months | |||
Additional interest rate | 7.50% | |||
CRG | ||||
Debt Instrument [Line Items] | ||||
Back end facility fee | $ 5,600,000 | |||
CRG | Interest Expense | ||||
Debt Instrument [Line Items] | ||||
Debt issuance costs | $ 5,200,000 | |||
Amortization of discount | 3,900,000 | |||
Loan preclosure fees | $ 2,800,000 | |||
CRG | Line of Credit | ||||
Debt Instrument [Line Items] | ||||
Borrowings outstanding | $ 45,000,000 | |||
CRG | Tranche Two | Line of Credit | ||||
Debt Instrument [Line Items] | ||||
Net proceeds in aggregate amount | $ 15,000,000 |
Notes Payable - Future Maturiti
Notes Payable - Future Maturities of the CRG Obligation (Detail) - CRG - Line of Credit $ in Thousands | Dec. 31, 2019USD ($) |
Debt Instrument [Line Items] | |
2020 | $ 0 |
2021 | 0 |
2022 | 13,846 |
2023 | 18,462 |
2024 | 18,462 |
2025 | 9,230 |
Total maturities | 60,000 |
Unamortized discount and loan costs | (1,432) |
Total notes payable obligation | $ 58,568 |
Net Sales by Product - Addition
Net Sales by Product - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2019Segment | |
Segment Reporting [Abstract] | |
Number of reportable segment | 1 |
Net Sales by Product - Summary
Net Sales by Product - Summary of Net Sales by Product (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Segment Reporting Information [Line Items] | |||||||||||||||
Net product sales | $ 31,637 | $ 30,306 | $ 29,677 | $ 19,769 | $ 18,028 | $ 14,156 | $ 12,175 | $ 11,281 | $ 12,510 | $ 11,253 | $ 8,744 | $ 29,478 | $ 111,389 | $ 55,640 | $ 61,985 |
BELBUCA | |||||||||||||||
Segment Reporting Information [Line Items] | |||||||||||||||
Net product sales | 97,538 | 45,988 | 26,980 | ||||||||||||
Symproic | |||||||||||||||
Segment Reporting Information [Line Items] | |||||||||||||||
Net product sales | 8,061 | 0 | 0 | ||||||||||||
BUNAVAIL | |||||||||||||||
Segment Reporting Information [Line Items] | |||||||||||||||
Net product sales | 2,289 | 5,422 | 7,942 | ||||||||||||
Product Sales | |||||||||||||||
Segment Reporting Information [Line Items] | |||||||||||||||
Net product sales | $ 107,888 | $ 51,410 | $ 34,922 | ||||||||||||
Sales Revenue, Net | Product Concentration Risk | BELBUCA | |||||||||||||||
Segment Reporting Information [Line Items] | |||||||||||||||
Percentage of amount due to major vendors accounts payable | 90.40% | 89.50% | 77.30% | ||||||||||||
Sales Revenue, Net | Product Concentration Risk | Symproic | |||||||||||||||
Segment Reporting Information [Line Items] | |||||||||||||||
Percentage of amount due to major vendors accounts payable | 7.50% | 0.00% | 0.00% | ||||||||||||
Sales Revenue, Net | Product Concentration Risk | BUNAVAIL | |||||||||||||||
Segment Reporting Information [Line Items] | |||||||||||||||
Percentage of amount due to major vendors accounts payable | 2.10% | 10.50% | 22.70% |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax [Line Items] | |||
Statutory income tax rate | 21.00% | 21.00% | 34.00% |
Tax cuts and jobs act, accounting complete | true | ||
Tax cuts and jobs act, refundable tax credit percentage | 50.00% | ||
Uncertain income tax positions | $ 0 | ||
Domestic Country | |||
Income Tax [Line Items] | |||
Operating loss carry forward | 271,000,000 | ||
Net operating loss used to offset taxable income | 1,500,000 | ||
State and Local Jurisdiction | |||
Income Tax [Line Items] | |||
Operating loss carry forward | $ 261,000,000 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Federal Statutory Income Tax Rate (Detail) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |||
Federal statutory income (benefit) tax rate | 21.00% | 21.00% | 34.00% |
2017 Tax Act, net deferred tax remeasurement | 0.00% | 0.00% | 626.73% |
State taxes, net of federal benefit | (0.18%) | (0.11%) | 2.01% |
Stock compensation | (5.39%) | (4.74%) | 5.18% |
Permanent differences-other | (7.67%) | (1.33%) | 13.39% |
North Carolina tax rate change | 0.00% | 0.00% | 32.75% |
Research and development (“R&D”) credit | 0.00% | 0.00% | (5.54%) |
Valuation release for bargain purchase gain | 0.00% | 0.00% | 302.23% |
Other | 1.71% | (2.07%) | 1.36% |
Decrease (increase) in valuation allowance | (9.44%) | (12.65%) | (709.88%) |
Effective tax rate | 0.03% | 0.10% | 302.23% |
Income Taxes - Significant Comp
Income Taxes - Significant Components of Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Income Tax Disclosure [Abstract] | ||
Basis difference in equipment | $ (438) | $ (459) |
Basis difference in intangibles | (5,356) | (6,045) |
Accrued liabilities and other | 3,942 | 2,246 |
R&D credit | 10,980 | 10,980 |
Stock options | 4,416 | 4,360 |
Net operating loss carry-forward | 62,535 | 64,376 |
Gross, Deferred Tax Assets | 76,079 | 75,458 |
Less: valuation allowance | (76,079) | (75,458) |
Net of Valuation Allowance | $ 0 | $ 0 |
Stockholder's Equity - Common S
Stockholder's Equity - Common Stock Narrative (Detail) - USD ($) $ in Millions | Nov. 09, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Aug. 02, 2018 | Aug. 01, 2018 | Dec. 31, 2017 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Common Stock, shares authorized (in shares) | 175,000,000 | 125,000,000 | 125,000,000 | 75,000,000 | 75,000,000 | |
Common Stock | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Company's securities for shelf registration | $ 125 |
Stockholder's Equity - Preferre
Stockholder's Equity - Preferred Stock Narrative (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||
May 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Authorized shares of preferred stock (in shares) | 5,000,000 | 5,000,000 | |||
Preferred stock, par value (in usd per share) | $ 0.001 | $ 0.001 | |||
Series B beneficial conversion feature | $ (12,500) | $ (12,500) | |||
Common Stock | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Series B conversion to Common Stock (in shares) | 13,788,888 | 10,555,556 | |||
Additional Paid-In Capital | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Series B beneficial conversion feature | $ 12,500 | ||||
Series A Preferred Stock | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Authorized shares of preferred stock (in shares) | 2,285,700 | ||||
Series B preferred shares outstanding (in shares) | 2,093,155 | 2,093,155 | 2,093,155 | 2,093,155 | |
Series A Preferred stock converted (in shares) | 0 | 0 | 0 | ||
Series B Non-Voting Convertible Preferred Stock | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Preferred stock, par value (in usd per share) | $ 0.001 | $ 0.001 | $ 0.001 | ||
Series B preferred shares outstanding (in shares) | 618 | 3,100 | |||
Sale and issue of preferred stock (in shares) | 5,000 | ||||
Purchase price of preferred stock | $ 10,000 | ||||
Series B beneficial conversion feature | $ (12,500) | ||||
Series B Preferred Stock | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Series B preferred shares outstanding (in shares) | 618 | 3,100 | 0 | 0 | |
Conversion price (in usd per share) | $ 1.80 | ||||
Series B conversion to Common Stock (in shares) | 27,777,778 | (2,482) | (1,900) |
Stockholder's Equity - Public O
Stockholder's Equity - Public Offering Narrative (Detail) - USD ($) $ / shares in Units, $ in Thousands | Apr. 15, 2019 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Series B issuance, net of issuance costs (in shares) | 12,000,000 | |||
Sales of stock, price per share (in usd per share) | $ 5 | |||
Sale of stock, number of shares issued in transaction (in shares) | 10,000,000 | |||
Proceeds from issuance of common stock before underwriting discounts, commissions, and other expenses | $ 50,000 | |||
Proceeds from issuance of common stock after underwriting discounts, commissions, and other expenses | 47,600 | |||
Proceeds from issuance of common stock, less underwriters discount | $ 19,000 | $ 48,000 | $ 0 | $ 0 |
IPO | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock options granted to underwriters (in shares) | 1,800,000 |
Stockholder's Equity - Stock Op
Stockholder's Equity - Stock Options Narrative (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||||
Jul. 11, 2011 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Jul. 25, 2019 | Aug. 02, 2018 | Aug. 01, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Common Stock, shares authorized (in shares) | 175,000,000 | 125,000,000 | 75,000,000 | 125,000,000 | 75,000,000 | |||
Shares reserved for issuance under 2019 plan (in shares) | 14,000,000 | |||||||
Options outstanding (in shares) | 5,496,971 | 4,406,004 | 2,712,954 | 3,468,991 | ||||
Company employees, directors and affiliates stock option exercised (in shares) | 799,800 | 350,441 | 202,519 | |||||
Proceeds from common stock | $ 2,321 | $ 670 | $ 439 | |||||
Weighted average grant date fair value of options granted (in usd per share) | $ 4.29 | $ 1.57 | $ 1.46 | |||||
Number of options granted in period with exercise price below market price (in shares) | 0 | 0 | 0 | |||||
Unrecognized compensation cost related to non-vested share-based compensation awards granted | $ 3,400 | |||||||
Unrecognized compensation cost related to non-vested share-based compensation awards granted year | 3 years | |||||||
Employees and Directors Stock Options | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Company employees, directors and affiliates stock option exercised (in shares) | 800,000 | 400,000 | 200,000 | |||||
Proceeds from common stock | $ 2,300 | $ 700 | $ 400 | |||||
Warrants | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Options outstanding (in shares) | 84,986 | |||||||
2011 Equity Incentive Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Increase in shares of common stock authorized (in shares) | 7,100,000 | |||||||
Options outstanding (in shares) | 4,369,045 | |||||||
2011 Equity Incentive Plan | Minimum | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Common Stock, shares authorized (in shares) | 11,050,000 | |||||||
2011 Equity Incentive Plan | Maximum | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Common Stock, shares authorized (in shares) | 18,150,000 | |||||||
Equity Incentive Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Weighted average remaining contractual life (years) | 10 years | |||||||
2001 Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||
Options outstanding (in shares) | 108,535 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares, outstanding at beginning of period (in shares) | 4,406,004 | 2,712,954 | 3,468,991 |
Number of shares, granted (in shares) | 2,388,752 | ||
Number of Shares, exercised (in shares) | (799,800) | (350,441) | (202,519) |
Number of Shares, forfeitures (in shares) | (497,985) | (505,686) | (1,510,193) |
Number of shares, outstanding at end of period (in shares) | 5,496,971 | 4,406,004 | 2,712,954 |
Weighted average exercise price per share, outstanding at beginning of period (in usd per share) | $ 3.19 | $ 2.98 | $ 4.14 |
Weighted average exercise price per share, exercised (in usd per share) | 2.90 | 2 | 2.17 |
Weighted average exercise price per share, forfeitures (in usd per share) | 2.03 | 3.48 | 5.13 |
Weighted average exercise price per share, outstanding at end of period (in usd per share) | $ 3.64 | $ 3.19 | $ 2.98 |
Aggregate intrinsic value, outstanding at beginning of period | $ 4,172 | $ 1,190 | $ 0 |
Aggregate intrinsic value, outstanding at end of period | $ 15,455 | $ 4,172 | $ 1,190 |
Officers and Directors | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares, granted (in shares) | 1,228,109 | 1,249,817 | 83,658 |
Weighted average exercise price per share, granted (in usd per share) | $ 4.08 | $ 2.49 | $ 2.64 |
Others | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of shares, granted (in shares) | 1,160,643 | 1,299,360 | 873,017 |
Weighted average exercise price per share, granted (in usd per share) | $ 4.51 | $ 2.60 | $ 1.96 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Stock Options Outstanding (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Number outstanding (in shares) | 5,496,971 | |||
Aggregate intrinsic value | $ 15,455 | $ 4,172 | $ 1,190 | $ 0 |
$1.00 - 5.00 | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Range of exercise prices, minimum (in usd per share) | $ 1 | $ 1 | ||
Range of exercise prices, maximum (in usd per share) | $ 5 | 5 | ||
Number outstanding (in shares) | 5,011,678 | |||
Weighted average remaining contractual life (years) | 8 years 4 months 17 days | |||
Weighted average exercise price (in usd per share) | $ 3.28 | |||
$5.01 - 10.00 | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Range of exercise prices, minimum (in usd per share) | 5.01 | 5.01 | ||
Range of exercise prices, maximum (in usd per share) | $ 10 | 10 | ||
Number outstanding (in shares) | 415,537 | |||
Weighted average remaining contractual life (years) | 6 years 9 months 21 days | |||
Weighted average exercise price (in usd per share) | $ 6.16 | |||
$ 10.01 - 15.00 | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Range of exercise prices, minimum (in usd per share) | 10.01 | 10.01 | ||
Range of exercise prices, maximum (in usd per share) | $ 15 | 15 | ||
Number outstanding (in shares) | 38,756 | |||
Weighted average remaining contractual life (years) | 5 years 1 month 24 days | |||
Weighted average exercise price (in usd per share) | $ 13.09 | |||
$15.01 - 20.00 | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||||
Range of exercise prices, minimum (in usd per share) | 15.01 | 15.01 | ||
Range of exercise prices, maximum (in usd per share) | $ 20 | $ 20 | ||
Number outstanding (in shares) | 31,000 | |||
Weighted average remaining contractual life (years) | 4 years 8 months 26 days | |||
Weighted average exercise price (in usd per share) | $ 16.20 |
Stockholders' Equity - Summar_3
Stockholders' Equity - Summary of Stock Options Exercisable (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||
Number exercisable (in shares) | 1,623,724 | |
Aggregate intrinsic value | $ 4,712 | |
$1.00 - 5.00 | ||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||
Range of exercise prices, minimum (in usd per share) | $ 1 | $ 1 |
Range of exercise prices, maximum (in usd per share) | $ 5 | 5 |
Number exercisable (in shares) | 1,284,107 | |
Weighted average remaining contractual life (years) | 7 years 5 months 15 days | |
Weighted average exercise price (in usd per share) | $ 2.63 | |
$5.01 - 10.00 | ||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||
Range of exercise prices, minimum (in usd per share) | 5.01 | 5.01 |
Range of exercise prices, maximum (in usd per share) | $ 10 | 10 |
Number exercisable (in shares) | 269,861 | |
Weighted average remaining contractual life (years) | 5 years 1 month 20 days | |
Weighted average exercise price (in usd per share) | $ 6.36 | |
$ 10.01 - 15.00 | ||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||
Range of exercise prices, minimum (in usd per share) | 10.01 | 10.01 |
Range of exercise prices, maximum (in usd per share) | $ 15 | 15 |
Number exercisable (in shares) | 38,756 | |
Weighted average remaining contractual life (years) | 5 years 1 month 24 days | |
Weighted average exercise price (in usd per share) | $ 13.09 | |
$15.01 - 20.00 | ||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||
Range of exercise prices, minimum (in usd per share) | 15.01 | 15.01 |
Range of exercise prices, maximum (in usd per share) | $ 20 | $ 20 |
Number exercisable (in shares) | 31,000 | |
Weighted average remaining contractual life (years) | 4 years 8 months 26 days | |
Weighted average exercise price (in usd per share) | $ 16.20 |
Stockholders' Equity - Summar_4
Stockholders' Equity - Summary of Non-Vested Stock Options (Detail) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($)$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Nonvested, Number of Shares [Roll Forward] | |
Nonvested at beginning of period (in shares) | 2,763,833 |
Nonvested, shares, granted (in shares) | 2,388,752 |
Nonvested, shares, vested (in shares) | (995,589) |
Nonvested, shares, forfeited (in shares) | (283,749) |
Nonvested at end of period (in shares) | 3,873,247 |
Weighted average grant date fair value, nonvested at December 31, 2018 (in usd per share) | $ / shares | $ 3.55 |
Nonvested at December 31, 2018, aggregate intrinsic value | $ | $ 10,743 |
Stockholder's Equity - Stock-Ba
Stockholder's Equity - Stock-Based Compensation Narrative (Detail) - Directors and Employees $ in Millions | 12 Months Ended |
Dec. 31, 2019USD ($)shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of equity instruments awarded in period (in shares) | shares | 2,388,752 |
Fair market value of shares granted | $ | $ 10.2 |
Term of options granted period (years) | 10 years |
Minimum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
RSU's Vested per performance criteria during period (years) | 1 year |
Maximum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
RSU's Vested per performance criteria during period (years) | 3 years |
Stockholder's Equity - Restrict
Stockholder's Equity - Restricted Stock Units Narrative (Detail) - Restricted Stock Units (RSUs) $ in Millions | 12 Months Ended |
Dec. 31, 2019USD ($)shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of equity instruments awarded in period (in shares) | 376,250 |
Fair market value of RSUs granted | $ | $ 1.7 |
Vesting period of options (years) | 3 years |
2011 Plan [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of equity instruments awarded in period (in shares) | 360,250 |
2019 Plan [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of equity instruments awarded in period (in shares) | 16,000 |
Stockholders' Equity - Summar_5
Stockholders' Equity - Summary of Restricted Stock Activity (Detail) - Restricted Stock Units (RSUs) | 12 Months Ended |
Dec. 31, 2019$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of restricted shares, Outstanding at beginning of period (in shares) | 2,166,102 |
Number of equity instruments awarded in period (in shares) | 376,250 |
Number of restricted shares, vested (in shares) | (806,661) |
Number of restricted shares, Forfeitures (in shares) | (87,132) |
Number of restricted shares, Outstanding at end of period (in shares) | 1,648,559 |
Weighted average fair market value per RSU, outstanding at beginning of period (in usd per share) | $ / shares | $ 2.59 |
Weighted average fair market value per RSU, vested (in usd per share) | $ / shares | 4.80 |
Weighted average fair market value per RSU, forfeitures (in usd per share) | $ / shares | 2.30 |
Weighted average fair market value per RSU, outstanding at end of period (in usd per share) | $ / shares | $ 3.86 |
Executive Officers | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of equity instruments awarded in period (in shares) | 223,250 |
Weighted average fair market value per RSU, granted (in usd per share) | $ / shares | $ 4.44 |
Directors | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of equity instruments awarded in period (in shares) | 106,000 |
Weighted average fair market value per RSU, granted (in usd per share) | $ / shares | $ 5.06 |
Employees | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of equity instruments awarded in period (in shares) | 47,000 |
Weighted average fair market value per RSU, granted (in usd per share) | $ / shares | $ 4.77 |
Stockholder's Equity - Long Ter
Stockholder's Equity - Long Term Incentive Plan Narrative (Detail) - Restricted Stock Units (RSUs) - shares | 12 Months Ended | |||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of restricted shares, vested (in shares) | 806,661 | |||
Awards returned during period (in shares) | 87,132 | |||
LTIP | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Restricted stock units ("RSUs") issued to directors and key employees (in shares) | 1,078,000 | 1,013,000 | ||
RSU's Vested per performance criteria during period (years) | 8 years | |||
Number of restricted shares, vested (in shares) | 54,755 | 31,036 | 9,958 | |
Awards returned during period (in shares) | 818,363 |
Stockholder's Equity - Warrants
Stockholder's Equity - Warrants (Detail) - USD ($) $ / shares in Units, $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options outstanding (in shares) | 5,496,971 | 4,406,004 | 2,712,954 | 3,468,991 |
Fair value of warrants | $ 6,000 | $ 6,000 | ||
MidCap Financial Trust | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares of common stock (in shares) | 84,986 | |||
Exercise price of warrants (in usd per share) | $ 3.53 | |||
Fair value of warrants | $ 50 | |||
CRG | Tranche One | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares of common stock (in shares) | 1,701,582 | |||
Exercise price of warrants (in usd per share) | $ 2.38 | |||
Fair value of warrants | $ 4,500 | |||
CRG | Tranche Two | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares of common stock (in shares) | 349,451 | |||
Exercise price of warrants (in usd per share) | $ 3.42 | |||
Fair value of warrants | $ 1,500 | |||
Warrants | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options outstanding (in shares) | 84,986 | |||
Warrants | CRG | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Options outstanding (in shares) | 2,051,034 |
Earnings per Common Share - Rec
Earnings per Common Share - Reconciliation of Numerators and Denominators (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Basic: | |||||||||||||||
Net (loss) income | $ (15,305) | $ (33,867) | $ 5,285 | ||||||||||||
Less deemed dividend related to beneficial conversion feature on Series B Preferred Stock | 0 | (12,500) | 0 | ||||||||||||
Net (loss) income attributable to common stockholders | $ (696) | $ 354 | $ (11,130) | $ (3,833) | $ (7,008) | $ (18,880) | $ (9,770) | $ (10,709) | $ (16,210) | $ (11,951) | $ (14,879) | $ 48,325 | $ (15,305) | $ (46,367) | $ 5,285 |
Weighted average common stock shares outstanding (in shares) | 83,213,704 | 63,165,063 | 55,355,802 | ||||||||||||
Basic (loss) income per common share (in usd per share) | $ 0 | $ 0 | $ (0.13) | $ (0.05) | $ (0.13) | $ (0.29) | $ (0.16) | $ (0.18) | $ (0.31) | $ (0.21) | $ (0.27) | $ 0.89 | $ (0.18) | $ (0.73) | $ 0.10 |
Effect of dilutive securities: | |||||||||||||||
Net (loss) income attributable to common stockholders, diluted | $ (15,305) | $ (46,367) | $ 5,285 | ||||||||||||
Weighted average common stock shares outstanding (in shares) | 83,213,704 | 63,165,063 | 55,355,802 | ||||||||||||
Effect of dilutive options and warrants (in shares) | 0 | 0 | 1,046,677 | ||||||||||||
Diluted weighted average common shares outstanding (in shares) | 83,213,704 | 63,165,063 | 56,402,479 | ||||||||||||
Diluted (loss) income per common share (in usd per share) | $ 0 | $ 0 | $ (0.13) | $ (0.05) | $ (0.13) | $ (0.29) | $ (0.16) | $ (0.18) | $ (0.30) | $ (0.21) | $ (0.27) | $ 0.87 | $ (0.18) | $ (0.73) | $ 0.09 |
Earnings per Common Share - Add
Earnings per Common Share - Additional Information (Detail) - shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Earnings Per Share [Abstract] | |||
Securities excluded from computation of diluted earnings per share | 11,116,195 | 28,424,998 | 6,531,346 |
Earnings per Common Share - Sch
Earnings per Common Share - Schedule of Total Outstanding Options, RSUs and Warrants (Detail) - shares | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Earnings Per Share [Abstract] | |||
Options, RSUs, warrants and convertible preferred stock to purchase Common Stock | 11,375,323 | 10,739,378 | 9,555,869 |
Retirement Plan (Detail)
Retirement Plan (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Retirement Benefits [Abstract] | |||
Employers' sponsors contribution retirement plan | 90.00% | ||
Contribution to retirement plan, percentage of employee contribution | 100.00% | ||
Percentage of employee contribution to retirement plan | 5.00% | ||
Employers' sponsors contribution retirement plan amount | $ 1 | $ 0.8 | $ 0.5 |
Commitments and Contingencies_2
Commitments and Contingencies (Detail) - USD ($) | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | |
CDC | |||
Contingencies And Commitments [Line Items] | |||
Royalties received | $ 20,000 | ||
Granted royalty on sales of the next BEMA product | 1.00% | ||
Net sales of next BEMA Product | $ 7,500,000 | ||
Minimum | CDC | |||
Contingencies And Commitments [Line Items] | |||
Royalties received | $ 375,000 | ||
Opioid PMR Consortium | |||
Contingencies And Commitments [Line Items] | |||
Participation expense | $ 4,300,000 |
Selected Quarterly Results (U_3
Selected Quarterly Results (Unaudited) (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Selected Quarterly Financial Information [Abstract] | |||||||||||||||
Revenue | $ 31,637 | $ 30,306 | $ 29,677 | $ 19,769 | $ 18,028 | $ 14,156 | $ 12,175 | $ 11,281 | $ 12,510 | $ 11,253 | $ 8,744 | $ 29,478 | $ 111,389 | $ 55,640 | $ 61,985 |
Gross profit | 24,372 | 24,956 | 24,754 | 15,717 | 14,005 | 10,377 | 7,609 | 7,866 | 7,275 | 6,808 | 4,573 | 23,833 | |||
Income (loss) from operations | 613 | 1,596 | 2,799 | (1,272) | (4,448) | (3,811) | (7,266) | (8,123) | (14,291) | (10,045) | (12,987) | 7,903 | 3,736 | (23,648) | (29,420) |
Net income (loss) | $ (696) | $ 354 | $ (11,130) | $ (3,833) | $ (7,008) | $ (18,880) | $ (9,770) | $ (10,709) | $ (16,210) | $ (11,951) | $ (14,879) | $ 48,325 | $ (15,305) | $ (46,367) | $ 5,285 |
Basic (loss) earnings per share (in usd per share) | $ 0 | $ 0 | $ (0.13) | $ (0.05) | $ (0.13) | $ (0.29) | $ (0.16) | $ (0.18) | $ (0.31) | $ (0.21) | $ (0.27) | $ 0.89 | $ (0.18) | $ (0.73) | $ 0.10 |
Diluted (loss) earnings per share (in usd per share) | $ 0 | $ 0 | $ (0.13) | $ (0.05) | $ (0.13) | $ (0.29) | $ (0.16) | $ (0.18) | $ (0.30) | $ (0.21) | $ (0.27) | $ 0.87 | $ (0.18) | $ (0.73) | $ 0.09 |
Schedule II - Valuation and Q_2
Schedule II - Valuation and Qualifying Accounts and Reserves (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |||
Charged to other accounts | $ 0 | $ 0 | $ 0 |
Valuation Allowance for Deferred Tax Assets | |||
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |||
Balance at beginning of the period | 75,458 | 71,515 | 109,030 |
Charged to income | 1,235 | 3,943 | (37,515) |
Charged to other accounts | 0 | 0 | 0 |
Deductions | 0 | 0 | 0 |
Balance at end of the period | 76,693 | 75,458 | 71,515 |
Allowance for Rebates | |||
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |||
Balance at beginning of the period | 12,261 | 5,648 | 3,842 |
Charged to income | 81,217 | 37,070 | 17,236 |
Charged to other accounts | 1,664 | 813 | (132) |
Deductions | (65,801) | (31,270) | (15,298) |
Balance at end of the period | 29,341 | 12,261 | 5,648 |
Allowance for Price Adjustments and Chargebacks | |||
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |||
Balance at beginning of the period | 4,018 | 3,925 | 602 |
Charged to income | 29,552 | 13,033 | 6,738 |
Charged to other accounts | 1 | 0 | (3) |
Deductions | (26,647) | (12,940) | (3,412) |
Balance at end of the period | 6,924 | 4,018 | 3,925 |
Allowance for inventory obsolescence | |||
SEC Schedule, 12-09, Valuation and Qualifying Accounts Disclosure [Line Items] | |||
Balance at beginning of the period | 187 | 243 | 0 |
Charged to income | 149 | (56) | 243 |
Deductions | (92) | 0 | 0 |
Balance at end of the period | $ 244 | $ 187 | $ 243 |
Uncategorized Items - bdsi-2019
Label | Element | Value |
Right-of-Use Asset Obtained in Exchange for Operating Lease Liability | us-gaap_RightOfUseAssetObtainedInExchangeForOperatingLeaseLiability | $ 900,000 |