Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2019 | May 06, 2019 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | BDSI | |
Entity Registrant Name | BIODELIVERY SCIENCES INTERNATIONAL INC | |
Entity Central Index Key | 0001103021 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 87,402,762 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash | $ 41,329 | $ 43,822 |
Accounts receivable, net | 16,008 | 13,627 |
Inventory, net | 7,259 | 5,406 |
Prepaid expenses and other current assets | 2,970 | 3,188 |
Total current assets | 67,566 | 66,043 |
Property and equipment, net | 3,952 | 3,072 |
Goodwill | 2,715 | 2,715 |
BELBUCA license and distribution rights, net | 34,875 | 36,000 |
Other intangible assets, net | 539 | 703 |
Total assets | 109,647 | 108,533 |
Current liabilities: | ||
Accounts payable and accrued liabilities | 23,484 | 21,539 |
Total current liabilities | 23,484 | 21,539 |
Notes payable, net | 52,286 | 51,652 |
Other long-term liabilities | 6,355 | 5,600 |
Total liabilities | 82,125 | 78,791 |
Commitments and contingencies (Note 11) | ||
Stockholders' equity: | ||
Preferred Stock | 2 | 2 |
Common Stock, $.001 par value; 125,000,000 shares authorized at March 31, 2019 and December 31, 2018, respectively; 75,333,254 and 75,793,725 shares issued;75,317,763 and 70,778,234 shares outstanding at March 31, 2019 and December 31, 2018, respectively. | 74 | 71 |
Additional paid-in capital | 382,614 | 381,004 |
Treasury stock, at cost, 15,491 shares | (47) | (47) |
Accumulated deficit | (355,121) | (351,288) |
Total stockholders' equity | 27,522 | 29,742 |
Total liabilities and stockholders' equity | $ 109,647 | $ 108,533 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2019 | Dec. 31, 2018 |
Preferred Stock, par value | $ 0.001 | |
Common Stock, par value | $ 0.001 | $ 0.001 |
Common Stock, shares authorized | 125,000,000 | 125,000,000 |
Common Stock, shares issued | 75,333,254 | 75,793,725 |
Common Stock, shares outstanding | 75,317,763 | 70,778,234 |
Treasury stock, shares | 15,491 | 15,491 |
Series A Non-Voting Convertible Preferred Stock [Member] | ||
Preferred Stock, par value | $ 0.001 | $ 0.001 |
Preferred Stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred Stock, shares outstanding | 2,093,155 | 2,093,155 |
Series B Non-Voting Convertible Preferred Stock [Member] | ||
Preferred Stock, par value | $ 0.001 | $ 0.001 |
Preferred Stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred Stock, shares outstanding | 2,400 | 3,100 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Revenues: | ||
Total revenues | $ 19,769 | $ 11,281 |
Cost of sales | 4,052 | 3,415 |
Expenses: | ||
Research and development | 2,484 | |
Selling, general and administrative | 16,989 | 13,505 |
Total expenses | 16,989 | 15,989 |
Loss from operations | (1,272) | (8,123) |
Interest expense, net | (2,561) | (2,505) |
Other expense, net | (7) | |
Loss before income taxes | (3,833) | (10,635) |
Income tax expense | (74) | |
Net loss attributable to common stockholders | $ (3,833) | $ (10,709) |
Basic and diluted: | ||
Weighted average common stock shares outstanding | 71,344,831 | 58,062,997 |
Basic and diluted loss per share | $ (0.05) | $ (0.18) |
Product Sales [Member] | ||
Revenues: | ||
Total revenues | $ 19,759 | $ 9,838 |
Product Royalty Revenues [Member] | ||
Revenues: | ||
Total revenues | 2 | 440 |
Contract Revenues [Member] | ||
Revenues: | ||
Total revenues | $ 8 | $ 1,003 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Treasury Stock [Member] | Accumulated Deficit [Member] | Series A Preferred Stock [Member] | Series B Preferred Stock [Member] |
Beginning Balance at Dec. 31, 2017 | $ 8,877 | $ 56 | $ 313,922 | $ (47) | $ (305,056) | $ 2 | |
Beginning Balance, shares at Dec. 31, 2017 | 55,904,072 | 2,093,155 | |||||
Stock-based compensation | $ 2,921 | $ 2,921 | |||||
Stock-based compensation, Shares | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Stock option exercises | $ 130 | $ 130 | |||||
Stock option exercises, shares | 63,295 | ||||||
Restricted stock awards | $ 1 | (1) | |||||
Restricted stock awards, shares | 1,038,957 | ||||||
Common stock issuance upon retirement | $ 2 | (2) | |||||
Common stock issuance upon retirement, shares | 1,640,198 | ||||||
Cumulative effect of accounting change | 135 | $ 135 | |||||
Net loss | (10,709) | (10,709) | |||||
Ending Balance at Mar. 31, 2018 | 1,354 | $ 59 | 316,970 | $ (47) | (315,630) | $ 2 | |
Ending Balance, shares at Mar. 31, 2018 | 58,646,522 | 2,093,155 | |||||
Beginning Balance at Dec. 31, 2018 | 29,742 | $ 71 | 381,004 | $ (47) | $ (351,288) | $ 2 | |
Beginning Balance, shares at Dec. 31, 2018 | 70,793,725 | 2,093,155 | 3,100 | ||||
Stock-based compensation | $ 1,141 | $ 1,141 | |||||
Stock-based compensation, Shares | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Stock option exercises | $ 472 | $ 472 | |||||
Stock option exercises, shares | 150,275 | 150,275 | |||||
Restricted stock awards | $ (1) | 1 | |||||
Restricted stock awards, shares | 500,366 | ||||||
Series B conversion to Common Stock | $ 4 | (4) | |||||
Series B conversion to Common Stock, shares | 3,888,888 | 0 | (700) | ||||
Net loss | $ (3,833) | $ (3,833) | |||||
Ending Balance at Mar. 31, 2019 | $ 27,522 | $ 74 | $ 382,614 | $ (47) | $ (355,121) | $ 2 | |
Ending Balance, shares at Mar. 31, 2019 | 75,333,254 | 2,093,155 | 2,400 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Operating activities: | ||
Net loss | $ (3,833) | $ (10,709) |
Adjustments to reconcile net loss to net cash flows from operating activities | ||
Depreciation | 85 | 230 |
Accretion of debt discount and loan costs | 634 | 625 |
Amortization of intangible assets | 1,289 | 1,289 |
Provision (benefit) for inventory obsolescence | 149 | (66) |
Stock-based compensation expense | 1,141 | 2,921 |
Changes in assets and liabilities, net of effect of acquisition: | ||
Accounts receivable | (2,381) | 864 |
Inventories | (2,002) | 716 |
Prepaid expenses and other assets | 218 | 782 |
Accounts payable and accrued expenses | 1,814 | (3,413) |
Net cash flows from operating activities | (2,886) | (6,761) |
Investing activities: | ||
BELBUCA acquisition | (1,951) | |
Purchase of equipment | (73) | |
Disposal of property and equipment | (79) | |
Net cash flows from investing activities | (79) | (2,024) |
Financing activities: | ||
Proceeds from exercise of stock options | 472 | 130 |
Payment of deferred financing fees | (450) | |
Net cash flows from (used in) financing activities | 472 | (320) |
Net change in cash and cash equivalents | (2,493) | (9,105) |
Cash and cash equivalents at beginning of period | 43,822 | 21,195 |
Cash and cash equivalents at end of period | 41,329 | 12,090 |
Cash paid for interest | $ 1,931 | $ 1,880 |
Organization, Basis of Presenta
Organization, Basis of Presentation and Summary of Significant Policies | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Organization, Basis of Presentation and Summary of Significant Policies | 1. Organization, basis of presentation and summary of significant policies: Overview BioDelivery Sciences International, Inc., together with its subsidiaries (collectively, the “Company”) is a rapidly growing commercial-stage 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 (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 United States using its own sales force while working in partnership with third parties to commercialize its products outside the United States. The accompanying unaudited condensed consolidated financial statements include all adjustments (consisting of normal and recurring adjustments) necessary for a fair presentation of these financial statements. The condensed consolidated balance sheet at December 31, 2018 has been derived from the Company’s audited consolidated financial statements included in its annual report on Form 10-K Form 10-K Operating results for the three-month period ended March 31, 2019 are not necessarily indicative of results for the full year or any other future periods. As used herein, the Company’s common stock, par value $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 condensed consolidated financial statements include the accounts of the Company, Arius Pharmaceuticals, Inc. (“Arius”), Arius Two, Inc. (“Arius Two”) and Bioral Nutrient Delivery, LLC (“BND”). For each period presented, BND has been an inactive subsidiary. All significant inter-company balances and transactions have been eliminated. Use of estimates in financial statements The preparation of the accompanying consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the period. Actual results could differ from those estimates. The Company reviews all significant estimates affecting the consolidated financial statements on a recurring basis and records the effect of any necessary adjustments prior to their issuance. Significant estimates of the Company include: revenue recognition, sales allowances such as returns of product sold, government program rebates, customer coupon redemptions, wholesaler/pharmacy discounts, product service fees, rebates and chargebacks, sales bonuses, stock-based compensation, determination of fair values of assets and liabilities relating to business combinations, and deferred income taxes. Inventory Inventories are stated at the lower of cost or net realizable value with costs determined for each batch under the first-in, first-out On a quarterly basis, the Company analyzes its inventory levels and records allowances for inventory that has become obsolete, inventory that has a cost basis in excess of the expected net realizable value and inventory that is in excess of expected demand based upon projected product sales. The Company reserved $0.3 million and $0.2 million for inventory obsolescence as of March 31, 2019 and December 31, 2018, respectively. Revenue recognition The main types of revenue contracts are: • Product sales- • Product royalty revenues- • Contract revenue- 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 obligations 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 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. 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 18-month Rebates- Price adjustments and chargebacks- The Company, from time to time, offers certain promotional product-related incentives to its customers. These programs include certain product incentives to pharmacy customers and other sales stocking allowances. The Company has voucher programs for BELBUCA and BUNAVAIL whereby the Company offers a point-of-sale Prompt payment discounts Gross to net accruals Cost of sales Cost of sales includes the direct costs attributable to the production of BELBUCA and BUNAVAIL. It includes raw materials, production costs at the Company’s three contract manufacturing sites, quality testing directly related to the products, and depreciation on equipment that the Company has 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 Cost of sales also includes royalty expenses that the Company owes to third parties. Research and development 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 three months ended March 31, 2019. Research and development expense for the three months ended March 31, 2018 was $2.5 million. Recent accounting pronouncements-adopted On January 1, 2019, the Company adopted 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 condensed Consolidated Statements of Operations on a straight-line basis over the lease term. As of March 31, 2019, the Company has approximately $1.2 million in future minimum lease commitments. Under the new standard, the Company’s lease liability is based on the present value of such payments and the related right-of-use Upon adoption, the Company recorded the right-of-use The impact of the adoption of Topic 842 on the accompanying condensed Consolidated Balance Sheet as of January 1, 2019 is as follows (in thousands): December 31, Adjustments Due to the Adoption of Topic 842 January 1, Right-of-use- Lease 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: Three Months Ended March 31 2019 2018 Lease Cost Operating lease cost Operating lease $ 82 $ 81 Variable lease costs 5 1 Total lease cost $ 87 $ 82 The additional disclosures required by ASU 2016-02 |
Leases
Leases | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Leases | 2. Leases: Supplemental cash flow information related to leases were as follows: Three Months Ended March 31 2019 2018 Other Information Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ 87 $ 82 Three Months Ended March 31 2019 2018 Lease Term and Discount Rate Weighted-average remaining lease term Operating leases 3.3 years 4.3 years Weighted-average discount rate Operating leases 11.8 % 11.8 % Maturity of Lease Liabilities Future minimum lease payments under non-cancellable Maturity of Lease Liabilities 2019 $ 264 2020 360 2021 370 2022 219 Total lease payments $ 1,213 Less: Interest (207 ) Present value of lease liabilities $ 1,006 Components of Lease Assets and Liabilities March 31, Assets Property and equipment, net Operating lease-right of use asset $ 887 Liabilities Current liabilities Operating lease- current liability $ 251 Other long-term liabilities Operating lease- noncurrent liability $ 755 Total lease liabilities $ 1,006 |
Liquidity and Management's Plan
Liquidity and Management's Plans | 3 Months Ended |
Mar. 31, 2019 | |
Text Block [Abstract] | |
Liquidity and Management's Plans | 3. Liquidity and management’s plans: At March 31, 2019, the Company had cash of approximately $41.3 million. The Company used $2.9 million of cash in operations during the three months ended March 31, 2019 and had stockholders’ equity of $27.5 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. Additional funding, capital or loans (including, without limitation, milestone or other payments from commercialization agreements) may be unavailable on favorable terms, if at all, which could leave the Company without adequate capital resources. |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Inventory | 4. Inventory: The following table represents the components of inventory as of: March 31, December 31, Raw materials & supplies $ 1,043 $ 645 Work-in-process 3,154 2,093 Finished goods 3,398 2,855 Obsolescence reserve (336 ) (187 ) Total inventories $ 7,259 $ 5,406 |
Accounts Payable and Accrued Li
Accounts Payable and Accrued Liabilities | 3 Months Ended |
Mar. 31, 2019 | |
Payables and Accruals [Abstract] | |
Accounts Payable and Accrued Liabilities | 5. Accounts payable and accrued liabilities: The following table represents the components of accounts payable and accrued liabilities as of: March 31, December 31, Accounts payable $ 2,672 $ 3,166 Accrued rebates 14,524 12,261 Accrued compensation and benefits 3,106 3,814 Accrued acquisition costs — 318 Accrued returns 677 715 Accrued royalties 562 159 Accrued clinical trial costs — 464 Accrued legal 382 70 Accrued regulatory expenses 537 — Accrued other 1,024 572 Total accounts payable and accrued liabilities $ 23,484 $ 21,539 |
Property and Equipment
Property and Equipment | 3 Months Ended |
Mar. 31, 2019 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 6. Property and equipment: Property and equipment, summarized by major category, consist of the following as of: March 31, December 31, Machinery & equipment $ 5,635 $ 5,635 Right of use, building lease 886 — Computer equipment & software 406 406 Office furniture & equipment 155 155 Leasehold improvements 43 43 Idle equipment 679 679 Total 7,804 6,918 Less accumulated depreciation and amortization (3,852 ) (3,846 ) Total property and equipment, net $ 3,952 $ 3,072 |
License Agreements and Acquired
License Agreements and Acquired Product Rights | 3 Months Ended |
Mar. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
License Agreements and Acquired Product Rights | 7. License agreements and acquired product rights: TTY license and supply agreement The Company has 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. The Company received cumulative payments $0.4 million from TTY during the three month periods ended March 31, 2018 related to royalties based on product purchased in Taiwan by TTY of PAINKYL which is recorded in the accompanying condensed consolidated statement of operations. There were no royalties received from TTY during the three months ended March 31, 2019. |
Notes Payable
Notes Payable | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Notes Payable | 8. Notes payable: The following table represents future maturities of the notes payable obligation as of March 31, 2019: 2019 — 2020 — 2021 30,892 2022 30,892 Total maturities $ 61,784 Unamortized discount and loan costs (9,498 ) Total notes payable obligation $ 52,286 |
Net Sales by Product
Net Sales by Product | 3 Months Ended |
Mar. 31, 2019 | |
Segment Reporting [Abstract] | |
Net Sales by Product | 9. Net sales by product: The Company’s business is classified as a single reportable segment. However, the following table presents net sales by product: Three months ended 2019 2018 BELBUCA $ 18,703 $ 8,024 BUNAVAIL 1,056 1,814 Net product sales $ 19,759 $ 9,838 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2019 | |
Federal Home Loan Banks [Abstract] | |
Stockholders' Equity | 10. Stockholders’ equity: Stock-based compensation During the three months ended March 31, 2019, a total of 2,031,033 options to purchase Common Stock, with an aggregate fair market value of approximately $4.1 million, were granted to employees and officers of the Company. Options have a term of 10 years from the grant date. Options granted to employees vest ratably over a three-year period and options granted to members of the Board of Directors vest ratably through 2022. The fair value of each option is amortized as compensation expense evenly through the vesting period. The fair value of each option award is estimated on the grant date using the Black-Scholes valuation model that uses assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate. Expected volatilities are based on implied volatilities from historical volatility of the Common Stock, and other factors estimated over the expected term of the options. Expected term of options granted is derived using the “simplified method” which computes expected term as the average of the sum of the vesting term plus contract term. The risk-free rate is based on the U.S. Treasury yield curve in effect at the time of grant for the period of the expected term. The key assumptions used in determining the fair value of options granted during the three months ended March 31, 2019 follows: Expected price volatility 61.83%-62.04% Risk-free interest rate 2.41%-2.66% Weighted average expected life in years 6 years Dividend yield — Option activity during the three months ended March 31, 2019 was as follows: Number of Weighted average Aggregate Outstanding at January 1, 2019 4,406,004 $ 3.19 $ 4,172 Granted in 2019: Officers and Directors 1,113,516 3.88 Employees 917,517 4.51 Exercised (150,275 ) 3.14 Forfeitures (10,423 ) 2.18 Outstanding at March 31, 2019 6,276,399 $ 3.50 $ 12,209 During the three months ended March 31, 2019, a cumulative total of 481,898 options were granted in excess of the Company’s 2011 Equity Incentive Plan, as amended (the “EIP”) available number of shares under the plan. These options are subject to shareholder approval at the Company’s 2019 Annual Shareholder’s Meeting. As of March 31, 2019, options exercisable totaled 1,780,405. There are approximately $10.6 million of unrecognized compensation cost related to non-vested Restricted stock units During the three months ended March 31, 2019, a cumulative total of 270,250 RSUs were granted to the Company’s executive officers, members of senior management and a former officer with a fair market value of approximately $1.2 million. The fair value of restricted units is determined using quoted market prices of the Common Stock and the number of shares expected to vest. These RSUs were issued under the EIP. RSU grants are time-based, all of which generally vest over a three-year period. The RSU grant to the former officer vested on his retirement date April 30, 2019. Restricted stock activity during the three months ended March 31, 2019 was as follows: Number of Weighted Outstanding at January 1, 2019 2,166,102 $ 2.59 Granted: Executive officers 223,250 4.44 Employees 47,000 4.67 Vested (500,366 ) 4.90 Outstanding at March 31, 2019 1,935,986 $ 2.98 Preferred Stock During the three months ended March 31, 2019, 700 shares of Series B Preferred Stock (“Series B”) were converted into 3,888,888 shares of Common Stock. As of March 31, 2019, 2,400 shares of Series B are outstanding. As of March 31, 2019, 2,093,155 shares of Series A Preferred Stock (“Series A”) are outstanding. There were no conversions of Series A during the three months ended March 31, 2019. Earnings Per Share During the three months ended March 31, 2019 and 2018, outstanding stock options, RSUs, warrants and preferred shares of 24,743,605 and 10,243,260 , respectively, were not included in the computation of diluted earnings per common share, because to do so would have had an antidilutive effect. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 11. Commitments and contingencies: The Company is involved from time to time in routine legal matters incidental to our business. Based upon available information, the Company believes that the resolution of such matters will not have a material adverse effect on its condensed consolidated financial position or results of operations. Except as discussed below, the Company is not the subject of any pending legal proceedings and, to the knowledge of management, no proceedings are presently contemplated against the Company by any federal, state or local governmental agency. 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. 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. 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. The case is now pending in the EDNC. 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 non-infringement 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 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 patents-in-suit Alvogen On September 7, 2018, the Company filed a complaint for patent infringement in Delaware 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 ® ® 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 Delaware 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 BELBUA 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 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. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2019 | |
Subsequent Events [Abstract] | |
Subsequent Events | 12. Subsequent events: License Agreement with Shionogi Inc. On April 4, 2019 (the “Effective Date”), the Company and Shionogi Inc. (“Shionogi”), entered into an exclusive license agreement for the commercialization of Symproic ® chronic non-cancer Pursuant to the terms of the license agreement, the Company agreed to pay Shionogi a $30 million up-front the six-month anniversary The Company and Shionogi have also entered into a customary supply agreement under which Shionogi will supply the product to the Company at cost plus an agreed upon markup for an initial term of up to two years. 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, or such later date as may be agreed by the parties pursuant to the transition services and distribution agreement. Public Offering. On April 11, 2019 the Company announced the pricing of 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, or net $47.5 million. The gross proceeds to the selling stockholder was approximately $10.0 million. The offering subsequently closed on April 15, 2019. |
Organization, Basis of Presen_2
Organization, Basis of Presentation and Summary of Significant Policies (Policies) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Overview | Overview BioDelivery Sciences International, Inc., together with its subsidiaries (collectively, the “Company”) is a rapidly growing commercial-stage 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 (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 United States using its own sales force while working in partnership with third parties to commercialize its products outside the United States. The accompanying unaudited condensed consolidated financial statements include all adjustments (consisting of normal and recurring adjustments) necessary for a fair presentation of these financial statements. The condensed consolidated balance sheet at December 31, 2018 has been derived from the Company’s audited consolidated financial statements included in its annual report on Form 10-K Form 10-K Operating results for the three-month period ended March 31, 2019 are not necessarily indicative of results for the full year or any other future periods. As used herein, the Company’s common stock, par value $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 condensed consolidated financial statements include the accounts of the Company, Arius Pharmaceuticals, Inc. (“Arius”), Arius Two, Inc. (“Arius Two”) and Bioral Nutrient Delivery, LLC (“BND”). For each period presented, BND has been an inactive subsidiary. All significant inter-company balances and transactions have been eliminated. |
Use of estimates in financial statements | Use of estimates in financial statements The preparation of the accompanying consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the period. Actual results could differ from those estimates. The Company reviews all significant estimates affecting the consolidated financial statements on a recurring basis and records the effect of any necessary adjustments prior to their issuance. Significant estimates of the Company include: revenue recognition, sales allowances such as returns of product sold, government program rebates, customer coupon redemptions, wholesaler/pharmacy discounts, product service fees, rebates and chargebacks, sales bonuses, stock-based compensation, determination of fair values of assets and liabilities relating to business combinations, and deferred income taxes. |
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 On a quarterly basis, the Company analyzes its inventory levels and records allowances for inventory that has become obsolete, inventory that has a cost basis in excess of the expected net realizable value and inventory that is in excess of expected demand based upon projected product sales. The Company reserved $0.3 million and $0.2 million for inventory obsolescence as of March 31, 2019 and December 31, 2018, respectively. |
Revenue recognition | Revenue recognition The main types of revenue contracts are: • Product sales- • Product royalty revenues- • Contract revenue- 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 obligations 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 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. 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 18-month Rebates- Price adjustments and chargebacks- The Company, from time to time, offers certain promotional product-related incentives to its customers. These programs include certain product incentives to pharmacy customers and other sales stocking allowances. The Company has voucher programs for BELBUCA and BUNAVAIL whereby the Company offers a point-of-sale Prompt payment discounts Gross to net accruals |
Cost of sales | Cost of sales Cost of sales includes the direct costs attributable to the production of BELBUCA and BUNAVAIL. It includes raw materials, production costs at the Company’s three contract manufacturing sites, quality testing directly related to the products, and depreciation on equipment that the Company has 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 Cost of sales also includes royalty expenses that the Company owes to third parties. |
Research and development | Research and development 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 three months ended March 31, 2019. Research and development expense for the three months ended March 31, 2018 was $2.5 million. |
Recent accounting pronouncements-adopted | Recent accounting pronouncements-adopted On January 1, 2019, the Company adopted 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 condensed Consolidated Statements of Operations on a straight-line basis over the lease term. As of March 31, 2019, the Company has approximately $1.2 million in future minimum lease commitments. Under the new standard, the Company’s lease liability is based on the present value of such payments and the related right-of-use Upon adoption, the Company recorded the right-of-use The impact of the adoption of Topic 842 on the accompanying condensed Consolidated Balance Sheet as of January 1, 2019 is as follows (in thousands): December 31, Adjustments Due to the Adoption of Topic 842 January 1, Right-of-use- Lease 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: Three Months Ended March 31 2019 2018 Lease Cost Operating lease cost Operating lease $ 82 $ 81 Variable lease costs 5 1 Total lease cost $ 87 $ 82 The additional disclosures required by ASU 2016-02 |
Organization, Basis of Presen_3
Organization, Basis of Presentation and Summary of Significant Policies (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Accounting Policies [Abstract] | |
Schedule of Impact of Adoption of Topic 842 on Condensed Balance Sheet | The impact of the adoption of Topic 842 on the accompanying condensed Consolidated Balance Sheet as of January 1, 2019 is as follows (in thousands): December 31, Adjustments Due to the Adoption of Topic 842 January 1, Right-of-use- Lease 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 |
Schedule of Components of Lease Expense | The components of lease expense were as follows: Three Months Ended March 31 2019 2018 Lease Cost Operating lease cost Operating lease $ 82 $ 81 Variable lease costs 5 1 Total lease cost $ 87 $ 82 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Leases [Abstract] | |
Schedule of Supplemental Cash Flow Information | Supplemental cash flow information related to leases were as follows: Three Months Ended March 31 2019 2018 Other Information Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ 87 $ 82 Three Months Ended March 31 2019 2018 Lease Term and Discount Rate Weighted-average remaining lease term Operating leases 3.3 years 4.3 years Weighted-average discount rate Operating leases 11.8 % 11.8 % |
Schedule of Future Minimum Lease Payments | Future minimum lease payments under non-cancellable Maturity of Lease Liabilities 2019 $ 264 2020 360 2021 370 2022 219 Total lease payments $ 1,213 Less: Interest (207 ) Present value of lease liabilities $ 1,006 Components of Lease Assets and Liabilities March 31, Assets Property and equipment, net Operating lease-right of use asset $ 887 Liabilities Current liabilities Operating lease- current liability $ 251 Other long-term liabilities Operating lease- noncurrent liability $ 755 Total lease liabilities $ 1,006 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Inventory Disclosure [Abstract] | |
Summary of Inventories | The following table represents the components of inventory as of: March 31, December 31, Raw materials & supplies $ 1,043 $ 645 Work-in-process 3,154 2,093 Finished goods 3,398 2,855 Obsolescence reserve (336 ) (187 ) Total inventories $ 7,259 $ 5,406 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Liabilities (Tables) | 3 Months Ended |
Mar. 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: March 31, December 31, Accounts payable $ 2,672 $ 3,166 Accrued rebates 14,524 12,261 Accrued compensation and benefits 3,106 3,814 Accrued acquisition costs — 318 Accrued returns 677 715 Accrued royalties 562 159 Accrued clinical trial costs — 464 Accrued legal 382 70 Accrued regulatory expenses 537 — Accrued other 1,024 572 Total accounts payable and accrued liabilities $ 23,484 $ 21,539 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 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: March 31, December 31, Machinery & equipment $ 5,635 $ 5,635 Right of use, building lease 886 — Computer equipment & software 406 406 Office furniture & equipment 155 155 Leasehold improvements 43 43 Idle equipment 679 679 Total 7,804 6,918 Less accumulated depreciation and amortization (3,852 ) (3,846 ) Total property and equipment, net $ 3,952 $ 3,072 |
Notes Payable (Tables)
Notes Payable (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Debt Disclosure [Abstract] | |
Future Maturities of the Notes Payable Obligation | The following table represents future maturities of the notes payable obligation as of March 31, 2019: 2019 — 2020 — 2021 30,892 2022 30,892 Total maturities $ 61,784 Unamortized discount and loan costs (9,498 ) Total notes payable obligation $ 52,286 |
Net Sales by Product (Tables)
Net Sales by Product (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Segment Reporting [Abstract] | |
Summary of Net Sales by Product | However, the following table presents net sales by product: Three months ended 2019 2018 BELBUCA $ 18,703 $ 8,024 BUNAVAIL 1,056 1,814 Net product sales $ 19,759 $ 9,838 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2019 | |
Federal Home Loan Banks [Abstract] | |
Key Assumptions Used in Determining Fair Value of Options Granted | The key assumptions used in determining the fair value of options granted during the three months ended March 31, 2019 follows: Expected price volatility 61.83%-62.04% Risk-free interest rate 2.41%-2.66% Weighted average expected life in years 6 years Dividend yield — |
Summary of Stock Option Activity | Option activity during the three months ended March 31, 2019 was as follows: Number of Weighted average Aggregate Outstanding at January 1, 2019 4,406,004 $ 3.19 $ 4,172 Granted in 2019: Officers and Directors 1,113,516 3.88 Employees 917,517 4.51 Exercised (150,275 ) 3.14 Forfeitures (10,423 ) 2.18 Outstanding at March 31, 2019 6,276,399 $ 3.50 $ 12,209 |
Summary of Restricted Stock Activity | Restricted stock activity during the three months ended March 31, 2019 was as follows: Number of Weighted Outstanding at January 1, 2019 2,166,102 $ 2.59 Granted: Executive officers 223,250 4.44 Employees 47,000 4.67 Vested (500,366 ) 4.90 Outstanding at March 31, 2019 1,935,986 $ 2.98 |
Organization, Basis of Presen_4
Organization, Basis of Presentation and Summary of Significant Policies - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | ||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | |
Basis Of Presentation [Line Items] | |||
Common Stock, par value | $ 0.001 | $ 0.001 | |
Preferred Stock, par value | $ 0.001 | ||
Inventory obsolescence reserved | $ 336 | $ 200 | $ 187 |
Sales return maximum duration | 18 months | ||
Offered period for sales return prior to expiration | 6 months | ||
Offered period for sales return subsequent to expiration | 12 months | ||
Discount for prompt payment | 2.00% | ||
Research and development expense | $ 2,484 | ||
Future minimum lease payments | $ 1,200 | ||
Right of use lease asset | 887 | ||
Right of use lease liability | $ 1,006 | ||
Minimum [Member] | |||
Basis Of Presentation [Line Items] | |||
Accrual to payment cycle period | 1 month | ||
Maximum [Member] | |||
Basis Of Presentation [Line Items] | |||
Accrual to payment cycle period | 3 months |
Organization, Basis of Presen_5
Organization, Basis of Presentation and Summary of Significant Policies - Schedule of Impact of Adoption of Topic 842 on Condensed Balance Sheet (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Basis Of Presentation [Line Items] | |||
Property and equipment, net | $ 3,952 | $ 4,011 | $ 3,072 |
Current liabilities | 23,484 | 21,751 | 21,539 |
Other long-term liabilities | 6,355 | $ 6,422 | $ 5,600 |
Accounting Standards Update 2016-02 [Member] | Right Of Use Asset [Member] | |||
Basis Of Presentation [Line Items] | |||
Property and equipment, net | 939 | ||
Accounting Standards Update 2016-02 [Member] | Lease Liability [Member] | |||
Basis Of Presentation [Line Items] | |||
Current liabilities | 212 | ||
Other long-term liabilities | $ 822 |
Organization, Basis of Presen_6
Organization, Basis of Presentation and Summary of Significant Policies - Schedule of Components of Lease Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Accounting Policies [Abstract] | ||
Operating lease | $ 82 | $ 81 |
Variable lease costs | 5 | 1 |
Total lease cost | $ 87 | $ 82 |
Leases - Schedule of Supplement
Leases - Schedule of Supplemental Cash Flow Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Leases [Abstract] | ||
Operating cash flows from operating leases | $ 87 | $ 82 |
Weighted-average remaining lease term, operating leases | 3 years 3 months 18 days | 4 years 3 months 18 days |
Weighted-average discount rate, operating leases | 11.80% | 11.80% |
Leases - Schedule of Future Min
Leases - Schedule of Future Minimum Lease Payments (Detail) $ in Thousands | Mar. 31, 2019USD ($) |
Leases [Abstract] | |
2019 | $ 264 |
2020 | 360 |
2021 | 370 |
2022 | 219 |
Total lease payments | 1,213 |
Less: Interest | (207) |
Present value of lease liabilities | $ 1,006 |
Leases - Components of Lease (D
Leases - Components of Lease (Detail) $ in Thousands | Mar. 31, 2019USD ($) |
Assets | |
Property and equipment, net Operating lease-right of use asset | $ 887 |
Liabilities | |
Current liabilities Operating lease- current liability | 251 |
Other long-term liabilities Operating lease- noncurrent liability | 755 |
Total lease liabilities | $ 1,006 |
Liquidity and Management's Pl_2
Liquidity and Management's Plans - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |||
Mar. 31, 2019 | Mar. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Liquidity And Managements Plans [Abstract] | ||||
Cash | $ 41,329 | $ 12,090 | $ 43,822 | $ 21,195 |
Net cash flows from operating activities | (2,886) | (6,761) | ||
Stockholders' equity | $ 27,522 | $ 1,354 | $ 29,742 | $ 8,877 |
Inventory - Summary of Inventor
Inventory - Summary of Inventories (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 | Mar. 31, 2018 |
Inventory Disclosure [Abstract] | |||
Raw materials & supplies | $ 1,043 | $ 645 | |
Work-in-process | 3,154 | 2,093 | |
Finished goods | 3,398 | 2,855 | |
Obsolescence reserve | (336) | (187) | $ (200) |
Total inventories | $ 7,259 | $ 5,406 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Liabilities - Summary of Components of Accounts Payable and Accrued Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Dec. 31, 2018 |
Payables and Accruals [Abstract] | ||
Accounts payable | $ 2,672 | $ 3,166 |
Accrued rebates | 14,524 | 12,261 |
Accrued compensation and benefits | 3,106 | 3,814 |
Accrued acquisition costs | 318 | |
Accrued returns | 677 | 715 |
Accrued royalties | 562 | 159 |
Accrued clinical trial costs | 464 | |
Accrued legal | 382 | 70 |
Accrued regulatory expenses | 537 | |
Accrued other | 1,024 | 572 |
Total accounts payable and accrued liabilities | $ 23,484 | $ 21,539 |
Property and Equipment - Summar
Property and Equipment - Summarized Category of Fixed Assets (Detail) - USD ($) $ in Thousands | Mar. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Property, Plant and Equipment [Line Items] | |||
Property, plant & equipment, gross | $ 7,804 | $ 6,918 | |
Less accumulated depreciation and amortization | (3,852) | (3,846) | |
Total property and equipment, net | 3,952 | $ 4,011 | 3,072 |
Machinery and Equipment [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant & equipment, gross | 5,635 | 5,635 | |
Right of use, building lease [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant & equipment, gross | 886 | ||
Computer Equipment and Software [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant & equipment, gross | 406 | 406 | |
Office Furniture and Equipment [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant & equipment, gross | 155 | 155 | |
Leasehold Improvements [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant & equipment, gross | 43 | 43 | |
Idle Equipment [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant & equipment, gross | $ 679 | $ 679 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation | $ 85 | $ 230 |
License Agreements and Acquir_2
License Agreements and Acquired Product Rights - Additional Information (Detail) - TTY License and Supply Agreement [Member] - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Indefinite-lived Intangible Assets [Line Items] | ||
Royalties received | $ 0.4 | |
Milestone payment received | $ 0 |
Notes Payable - Future Maturiti
Notes Payable - Future Maturities of the CRG Obligation (Detail) - CRG [Member] - Line of Credit [Member] $ in Thousands | Mar. 31, 2019USD ($) |
Debt Instrument [Line Items] | |
2019 | $ 0 |
2020 | 0 |
2021 | 30,892 |
2022 | 30,892 |
Total maturities | 61,784 |
Unamortized discount and loan costs | (9,498) |
Total notes payable obligation | $ 52,286 |
Net Sales by Product - Summary
Net Sales by Product - Summary of Net Sales by Product (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Sales Information [Line Items] | ||
Net product sales | $ 19,769 | $ 11,281 |
BELBUCA [Member] | ||
Sales Information [Line Items] | ||
Net product sales | 18,703 | 8,024 |
BUNAVAIL [Member] | ||
Sales Information [Line Items] | ||
Net product sales | 1,056 | 1,814 |
Product Sales [Member] | ||
Sales Information [Line Items] | ||
Net product sales | $ 19,759 | $ 9,838 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional information (Detail) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2019 | Mar. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation cost related to non-vested share-based compensation awards granted | $ 10.6 | |
Unrecognized compensation cost related to non-vested share-based compensation awards granted year | 2022 | |
Stock option exercisable | 1,780,405 | |
Antidilutive shares excluded from the computation of diluted earnings per common share | 24,743,605 | 10,243,260 |
2011 Equity Incentive Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of equity instruments awarded in period | 481,898 | |
Restricted Stock Units (RSUs) [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of equity instruments awarded in period | 270,250 | |
Vesting period of shares | 3 years | |
Fair market value of RSUs granted | $ 1.2 | |
Series B Preferred Stock [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Conversion of Series A preferred stock | (700) | |
Series A preferred shares outstanding | 2,400 | |
Series A Preferred Stock [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Conversion of Series A preferred stock | 0 | |
Series A preferred shares outstanding | 2,093,155 | |
Common Stock [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Conversion of Series A preferred stock | 3,888,888 | |
Board of Directors and Employee [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of equity instruments awarded in period | 2,031,033 | |
Fair market value of shares granted | $ 4.1 | |
Term of options granted period | 10 years | |
Employees [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period of shares | 3 years | |
Employees [Member] | Restricted Stock Units (RSUs) [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Number of equity instruments awarded in period | 47,000 | |
Board of Director [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period of shares, Description | Options granted to members of the Board of Directors vest ratably through 2022 |
Stockholders' Equity - Key Assu
Stockholders' Equity - Key Assumptions Used in Determining Fair Value of Options Granted (Detail) | 3 Months Ended |
Mar. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Weighted average expected life in years | 6 years |
Dividend yield | 0.00% |
Minimum [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Expected price volatility | 61.83% |
Risk-free interest rate | 2.41% |
Dividend yield | 0.00% |
Maximum [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Expected price volatility | 62.04% |
Risk-free interest rate | 2.66% |
Dividend yield | 0.00% |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Stock Option Activity (Detail) $ / shares in Units, $ in Thousands | 3 Months Ended |
Mar. 31, 2019USD ($)$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of shares, Outstanding at beginning of period | shares | 4,406,004 |
Number of shares, Exercised | shares | (150,275) |
Number of shares, Forfeitures | shares | (10,423) |
Number of shares, Outstanding at end of period | shares | 6,276,399 |
Weighted average exercise price per share, Outstanding at beginning of period | $ / shares | $ 3.19 |
Weighted average exercise price per share, Exercised | $ / shares | 3.14 |
Weighted average exercise price per share, Forfeitures | $ / shares | 2.18 |
Weighted average exercise price per share, Outstanding at end of period | $ / shares | $ 3.50 |
Aggregate intrinsic value, Outstanding, balance | $ | $ 4,172 |
Aggregate intrinsic value, Outstanding, balance | $ | $ 12,209 |
Officers and Directors [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of shares, Granted | shares | 1,113,516 |
Weighted average exercise price per share, Granted | $ / shares | $ 3.88 |
Employees [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of shares, Granted | shares | 917,517 |
Weighted average exercise price per share, Granted | $ / shares | $ 4.51 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Restricted Stock Activity (Detail) - Restricted Stock Units (RSUs) [Member] | 3 Months Ended |
Mar. 31, 2019$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of restricted shares, Outstanding at beginning of period | 2,166,102 |
Number of Shares, Granted | 270,250 |
Number of restricted shares, Vested | (500,366) |
Number of restricted shares, Outstanding at end of period | 1,935,986 |
Weighted average fair market value per RSU, Outstanding at beginning of period | $ / shares | $ 2.59 |
Weighted average fair market value per RSU, Vested | $ / shares | 4.90 |
Weighted average fair market value per RSU, Outstanding at end of period | $ / shares | $ 2.98 |
Executive Officers [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares, Granted | 223,250 |
Weighted average fair market value per RSU, Granted | $ / shares | $ 4.44 |
Employees [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of Shares, Granted | 47,000 |
Weighted average fair market value per RSU, Granted | $ / shares | $ 4.67 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - Subsequent Event [Member] - USD ($) $ / shares in Units, $ in Millions | Apr. 11, 2019 | Apr. 04, 2019 |
Subsequent Event [Line Items] | ||
License arrangement upfront payment | $ 30 | |
Percentage of net sales pertaining to additional royalties | 1.00% | |
Stock issued during period, shares, new issues | 12,000,000 | |
Sale of stock, price per share | $ 5 | |
Sale of stock, number of shares issued in transaction | 10,000,000 | |
Proceeds from issuance common stock before underwriters discounts and commissions and offering expenses | $ 50 | |
Proceeds from issuance common stock net of underwriters discounts and commissions and offering expenses | 47.5 | |
Gross proceeds to selling stockholder from public offering | $ 10 | |
Minimum [Member] | ||
Subsequent Event [Line Items] | ||
Percentage of royalty on sales | 8.50% | |
Maximum [Member] | ||
Subsequent Event [Line Items] | ||
Percentage of royalty on sales | 17.50% | |
First Installment [Member] | ||
Subsequent Event [Line Items] | ||
License arrangement upfront payment | $ 20 | |
Second Installment [Member] | ||
Subsequent Event [Line Items] | ||
License arrangement upfront payment | $ 10 |