Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2019 | Nov. 12, 2019 | |
Cover page. | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Registrant Name | BioDelivery Sciences International, Inc. | |
Entity Address, Address Line One | 4131 ParkLake Ave., 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 | |
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 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q3 | |
Entity Central Index Key | 0001103021 | |
Current Fiscal Year End Date | --12-31 | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2019 | |
Entity common stock, shares outstanding (in shares) | 89,912,728 | |
Entity Tax Identification Number | 35-2089858 | |
Entity Incorporation, State or Country Code | DE | |
Entity File Number | 001-31361 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 55,863 | $ 43,822 |
Accounts receivable, net | 33,422 | 13,627 |
Inventory, net | 10,766 | 5,406 |
Prepaid expenses and other current assets | 4,874 | 3,188 |
Total current assets | 104,925 | 66,043 |
Property and equipment, net | 3,713 | 3,072 |
Goodwill | 2,715 | 2,715 |
License and distribution rights, net | 62,044 | 36,000 |
Other intangible assets, net | 211 | 703 |
Total assets | 173,608 | 108,533 |
Current liabilities: | ||
Accounts payable and accrued liabilities | 46,545 | 21,539 |
Total current liabilities | 46,545 | 21,539 |
Notes payable, net | 58,515 | 51,652 |
Other long-term liabilities | 654 | 5,600 |
Total liabilities | 105,714 | 78,791 |
Commitments and contingencies (Note 11) | ||
Stockholders' equity: | ||
Preferred Stock, 5,000,000 shares authorized; Series A Non-Voting Convertible Preferred Stock. $.001 par value, 2,093,155 shares outstanding at both September 30, 2019 and December 31, 2018, respectively; Series B Non-Voting Convertible Preferred Stock, $.001 par value, 1,698 and 3,100 shares outstanding at September 30, 2019 and December 31, 2018, respectively. | 2 | 2 |
Common Stock, $.001 par value; 175,000,000 shares authorized at September 30, 2019 and 125,000,000 shares authorized at December 31, 2018, respectively; 89,796,774 and 70,793,725 shares issued;89,781,283 and 70,778,234 shares outstanding at September 30, 2019 and December 31, 2018, respectively. | 90 | 71 |
Additional paid-in capital | 433,746 | 381,004 |
Treasury stock, at cost, 15,491 shares | (47) | (47) |
Accumulated deficit | (365,897) | (351,288) |
Total stockholders' equity | 67,894 | 29,742 |
Total liabilities and stockholders' equity | $ 173,608 | $ 108,533 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2019 | Dec. 31, 2018 |
Preferred Stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
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) | 89,796,774 | 75,793,725 |
Common Stock, shares outstanding (in shares) | 89,781,283 | 70,778,234 |
Treasury stock, shares (in shares) | 15,491 | 15,491 |
Series A Preferred Stock | ||
Preferred Stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Preferred Stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred Stock, shares outstanding (in shares) | 2,093,155 | 2,093,155 |
Series B Preferred Stock | ||
Preferred Stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Preferred Stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred Stock, shares outstanding (in shares) | 1,698 | 3,100 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Revenues: | ||||
Total Revenues | $ 30,306,000 | $ 14,156,000 | $ 79,752,000 | $ 37,611,000 |
Cost of sales | 5,350,000 | 3,779,000 | 14,325,000 | 11,760,000 |
Expenses: | ||||
Research and development | 0 | 699,000 | 0 | 4,038,000 |
Selling, general and administrative | 23,360,000 | 13,489,000 | 62,304,000 | 41,013,000 |
Total Expenses: | 23,360,000 | 14,188,000 | 62,304,000 | 45,051,000 |
Income (loss) from operations | 1,596,000 | (3,811,000) | 3,123,000 | (19,200,000) |
Interest expense | (1,234,000) | (2,567,000) | (17,732,000) | (7,598,000) |
Other (expense) income, net | (3,000) | (2,000) | 5,000 | (8,000) |
Loss before income taxes | 359,000 | (6,380,000) | (14,604,000) | (26,806,000) |
Income tax benefit (expense) | (5,000) | 0 | (5,000) | (53,000) |
Net income (loss) | 354,000 | (6,380,000) | (14,609,000) | (26,859,000) |
Beneficial conversion feature of convertible preferred stock | 0 | (12,500,000) | 0 | (12,500,000) |
Net income (loss) attributable to common stockholders | $ 354,000 | $ (18,880,000) | $ (14,609,000) | $ (39,359,000) |
Basic and diluted: | ||||
Weighted average common stock shares outstanding, basic (in shares) | 89,649,922 | 64,900,007 | 81,612,112 | 60,599,456 |
Basic earnings (loss) per share (in usd per share) | $ 0 | $ (0.29) | $ (0.18) | $ (0.65) |
Weighted average common stock shares outstanding, diluted (in shares) | 105,138,894 | 64,900,007 | 81,612,112 | 60,599,456 |
Diluted earnings (loss) per share (in usd per share) | $ 0 | $ (0.29) | $ (0.18) | $ (0.65) |
Product sales | ||||
Revenues: | ||||
Total Revenues | $ 29,623,000 | $ 13,763,000 | $ 77,438,000 | $ 34,367,000 |
Product royalty revenues | ||||
Revenues: | ||||
Total Revenues | 683,000 | 370,000 | 2,154,000 | 2,197,000 |
Contract revenues] | ||||
Revenues: | ||||
Total Revenues | $ 0 | $ 23,000 | $ 160,000 | $ 1,047,000 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' 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 at Dec. 31, 2017 | $ 8,877 | $ 56 | $ 313,922 | $ (47) | $ (305,056) | $ 2 | $ 0 |
Beginning Balance (in shares) at Dec. 31, 2017 | 55,904,072 | 2,093,155 | 0 | ||||
Stock-based compensation | 4,896 | 4,896 | |||||
Stock option exercises | 528 | 528 | |||||
Stock option exercises (in shares) | 285,403 | ||||||
Restricted stock awards | 0 | $ 2 | (2) | ||||
Restricted stock awards (in shares) | 1,733,731 | ||||||
Common stock issuance upon retirement | 0 | $ 2 | (2) | ||||
Common stock issuance upon retirement (in shares) | 2,119,925 | ||||||
Series B issuance, net of issuance costs (in shares) | 5,000 | ||||||
Series B issuance, net of issuance cost | 47,993 | 47,993 | |||||
Series B conversion to common stock | 0 | $ 11 | (11) | ||||
Series B conversion to common stock (in shares) | 10,555,556 | (1,900) | |||||
Cumulative effect of accounting change | 135 | 135 | |||||
Series B beneficial conversion feature | 0 | 12,500 | (12,500) | ||||
Net income (loss) | (26,859) | (26,859) | |||||
Ending Balance at Sep. 30, 2018 | 35,570 | $ 71 | 379,824 | (47) | (344,280) | $ 2 | $ 0 |
Ending Balance (in shares) at Sep. 30, 2018 | 70,598,687 | 2,093,155 | 3,100 | ||||
Beginning Balance at Jun. 30, 2018 | 40,737 | $ 59 | 366,123 | (47) | (325,400) | $ 2 | $ 0 |
Beginning Balance (in shares) at Jun. 30, 2018 | 59,459,446 | 2,093,155 | 5,000 | ||||
Stock-based compensation | 892 | 892 | |||||
Stock option exercises | 222 | 222 | |||||
Stock option exercises (in shares) | 116,387 | ||||||
Restricted stock awards | 0 | $ 1 | (1) | ||||
Restricted stock awards (in shares) | 467,298 | ||||||
Series B issuance, net of issuance cost | 99 | 99 | |||||
Series B conversion to common stock | 0 | $ 11 | (11) | ||||
Series B conversion to common stock (in shares) | 10,555,556 | (1,900) | |||||
Cumulative effect of accounting change | 0 | ||||||
Series B beneficial conversion feature | 12,500 | (12,500) | |||||
Net income (loss) | (6,380) | (6,380) | |||||
Ending Balance at Sep. 30, 2018 | 35,570 | $ 71 | 379,824 | (47) | (344,280) | $ 2 | $ 0 |
Ending Balance (in shares) at Sep. 30, 2018 | 70,598,687 | 2,093,155 | 3,100 | ||||
Beginning Balance at Dec. 31, 2018 | 29,742 | $ 71 | 381,004 | (47) | (351,288) | $ 2 | $ 0 |
Beginning Balance (in shares) at Dec. 31, 2018 | 70,793,725 | 2,093,155 | 3,100 | ||||
Stock-based compensation | 3,978 | 3,978 | |||||
Stock option exercises | $ 1,193 | 1,193 | |||||
Stock option exercises (in shares) | 412,500 | 412,500 | |||||
Restricted stock awards | $ 0 | $ 1 | (1) | ||||
Restricted stock awards (in shares) | 801,661 | ||||||
Series B issuance, net of issuance costs (in shares) | 0 | ||||||
Series B conversion to common stock | 0 | $ 8 | (8) | ||||
Series B conversion to common stock (in shares) | 7,788,888 | (1,402) | |||||
Equity offering, net of finance costs | 47,590 | $ 10 | 47,580 | ||||
Equity offering, net of finance costs (in shares) | 10,000,000 | ||||||
Net income (loss) | (14,609) | (14,609) | |||||
Ending Balance at Sep. 30, 2019 | 67,894 | $ 90 | 433,746 | (47) | (365,897) | $ 2 | $ 0 |
Ending Balance (in shares) at Sep. 30, 2019 | 89,796,774 | 2,093,155 | 1,698 | ||||
Beginning Balance at Jun. 30, 2019 | 66,150 | $ 88 | 432,358 | (47) | (366,251) | $ 2 | $ 0 |
Beginning Balance (in shares) at Jun. 30, 2019 | 89,535,024 | 2,093,155 | 1,716 | ||||
Stock-based compensation | 1,267 | 1,267 | |||||
Stock option exercises | 123 | 123 | |||||
Stock option exercises (in shares) | 52,121 | ||||||
Restricted stock awards | 0 | $ 2 | (2) | ||||
Restricted stock awards (in shares) | 109,629 | ||||||
Series B conversion to common stock (in shares) | 100,000 | (18) | |||||
Net income (loss) | 354 | 354 | |||||
Ending Balance at Sep. 30, 2019 | $ 67,894 | $ 90 | $ 433,746 | $ (47) | $ (365,897) | $ 2 | $ 0 |
Ending Balance (in shares) at Sep. 30, 2019 | 89,796,774 | 2,093,155 | 1,698 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Operating activities: | ||
Net loss | $ (14,609) | $ (26,859) |
Adjustments to reconcile net loss to net cash flows from operating activities | ||
Depreciation and amortization | 253 | 685 |
Impairment loss on equipment | 0 | 78 |
Accretion of debt discount and loan costs | 11,441 | 2,953 |
Amortization of intangible assets | 5,084 | 3,868 |
Provision for inventory obsolescence | 57 | 396 |
Stock-based compensation expense | 3,978 | 4,896 |
Changes in assets and liabilities, net of effect of acquisition: | ||
Accounts receivable | (19,795) | (3,581) |
Inventories | (5,416) | 261 |
Prepaid expenses and other assets | (1,686) | (545) |
Accounts payable and accrued liabilities | 14,844 | (427) |
Net cash flows used in operating activities | (5,849) | (18,275) |
Investing activities: | ||
Product acquisitions | (20,674) | (1,951) |
Acquisitions of equipment | (79) | (155) |
Net cash flows used in investing activities | (20,753) | (2,106) |
Financing activities: | ||
Proceeds from issuance of common stock | 48,000 | 0 |
Proceeds from issuance of Series B preferred stock | 0 | 50,000 |
Equity issuance costs | (410) | (1,410) |
Proceeds from notes payable | 60,000 | 0 |
Proceeds from exercise of stock options | 1,193 | 528 |
Payment on note payable | (67,346) | 0 |
Loss on refinancing of former debt | (2,794) | 0 |
Payment of deferred financing fees | 0 | (450) |
Net cash flows provided by financing activities | 38,643 | 48,668 |
Net change in cash and cash equivalents | 12,041 | 28,287 |
Cash and cash equivalents at beginning of period | 43,822 | 21,195 |
Cash and cash equivalents at end of period | 55,863 | 49,482 |
Cash paid for interest | $ 5,339 | $ 4,645 |
Organization, Basis of Presenta
Organization, Basis of Presentation and Summary of Significant Policies | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Organization, Basis of Presentation and Summary of Significant Policies | 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 conditions. The Company is utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA) drug-delivery technology and other drug delivery technologies 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. In April 2019, the Company entered into an exclusive license agreement for the commercialization of Symproic (naldemedine tosylate) in the United States including Puerto Rico for opioid-induced constipation in adult patients with chronic non-cancer pain (Note 6). 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 for the year ended December 31, 2018. Certain footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to the Securities and Exchange Commission rules and regulations. It is recommended that these condensed consolidated financial statements be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s annual report on Form 10-K for the year ended December 31, 2018. Operating results for the three- and nine-month periods ended September 30, 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 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. Cash and cash equivalents Cash and cash equivalents consist of operating and money market accounts. Cash equivalents are carried at cost which approximates fair value due to their short-term nature. The Company considers all highly-liquid investments with an original maturity of 90 days or less to be cash equivalents. The Company maintains cash equivalent balances with financial institutions that management believes are of high credit quality. The Company’s cash and cash equivalents accounts at times may exceed federally insured limits. The Company has not experienced any losses in such accounts. The Company believes it is not exposed to any significant credit risk from cash and cash equivalents. 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 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 $0.2 million for inventory obsolescence as of both September 30, 2019 and December 31, 2018. Revenue recognition 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. • Product royalty revenues- Product royalty revenue amounts are based on sales revenue of the PAINKYL product under the Company’s license agreement with TTY and the BREAKYL 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. 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. 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. 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. The Company has 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 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. Since April 2019, cost of sales has also included direct costs attributable to the production of Symproic. 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. 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 September 30, 2019: Level 1 Level 2 Level 3 Balance at September 30, 2019 Cash and cash equivalents $ 55,863 — — $ 55,863 The cash and cash equivalent balance as of September 30, 2019 includes investments in various money market accounts and cash held in interest bearing accounts. 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 nine months ended September 30, 2019. Research and development expense for the nine months ended September 30, 2018 totaled $4.0 million. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Leases | Leases: The components of lease expense were as follows: Three months ended September 30, Nine months ended September 30, 2019 2018 2019 2018 Lease Cost Operating lease cost Operating lease $ 82 $ 81 $ 246 $ 244 Variable lease costs 3 1 10 1 Total lease cost $ 85 $ 82 $ 256 $ 245 Nine months ended September 30, 2019 2018 Other Information Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ 261 $ 245 Nine months ended September 30, 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 September 30, 2019 were as follows: Maturity of Lease Liabilities 2019 $ 89 2020 360 2021 370 2022 219 Total lease payments $ 1,038 Less: Interest (152) Present value of lease liabilities $ 886 Components of Lease Assets and Liabilities September 30, Assets Property and equipment, net Operating lease-right of use asset $ 777 Liabilities Current liabilities Operating lease- current liability $ 271 Other long-term liabilities Operating lease- noncurrent liability 615 Total lease liabilities $ 886 |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2019 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory: The following table represents the components of inventory as of: September 30, December 31, Raw materials & supplies $ 638 $ 645 Work-in-process 6,894 2,093 Finished goods 3,478 2,855 Obsolescence reserve (244) (187) Total inventories $ 10,766 $ 5,406 |
Accounts Payable and Accrued Li
Accounts Payable and Accrued Liabilities | 9 Months Ended |
Sep. 30, 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: September 30, December 31, Accounts payable $ 2,175 $ 3,166 Accrued rebates 24,625 12,261 Accrued compensation and benefits 4,662 3,814 Accrued acquisition costs 9,970 318 Accrued returns 1,477 715 Accrued royalties 419 159 Accrued clinical trial costs — 464 Accrued legal 556 70 Accrued interest expense 1,508 — Accrued regulatory expenses 282 — Accrued other 871 572 Total accounts payable and accrued liabilities $ 46,545 $ 21,539 |
Property and Equipment
Property and Equipment | 9 Months Ended |
Sep. 30, 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: September 30, December 31, Machinery & equipment $ 5,635 $ 5,635 Right of use, building lease 777 — Computer equipment & software 437 406 Office furniture & equipment 161 155 Leasehold improvements 43 43 Idle equipment 679 679 Total 7,732 6,918 Less accumulated depreciation and amortization (4,019) (3,846) Total property and equipment, net $ 3,713 $ 3,072 Depreciation expense for the three-month periods ended September 30, 2019 and September 30, 2018, was approximately $0.08 million and $0.2 million, respectively. Depreciation expense for the nine-month periods ended September 30, 2019 and September 30, 2018, was approximately $0.2 million and $0.7 million, respectively. |
License Agreements and Acquired
License Agreements and Acquired Product Rights | 9 Months Ended |
Sep. 30, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
License Agreements and Acquired Product Rights | License agreements and acquired product rights: Shionogi license and supply agreement 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 on October 4, 2019. Furthermore, the Company will pay quarterly tiered royalty payments on potential net 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 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 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 condensed consolidated statement of operations for the nine months ended September 30, 2019. The Company is amortizing the Symproic license over the life of the underlying patent, which the earliest date of generic entry for Symproic is November 2031 based on the expiration date of US patent # 9,108,975. |
Other Intangible Assets
Other Intangible Assets | 9 Months Ended |
Sep. 30, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Other Intangible Assets | Other intangible assets: Other intangible assets, net, consisting of product rights and licenses are summarized as follows: September 30, 2019 Gross Carrying Accumulated Intangible Assets, Product rights $ 6,050 $ (5,864) $ 186 BELBUCA license and distribution rights 45,000 (12,374) 32,626 Symproic license and distribution rights 30,636 (1,218) 29,418 Licenses 1,900 (1,875) 25 Total intangible assets $ 83,586 $ (21,331) $ 62,255 December 31, 2018 Gross Carrying Accumulated Intangible Assets, Product rights $ 6,050 $ (5,442) $ 608 BELBUCA license and distribution rights 45,000 (9,000) 36,000 Licenses 1,900 (1,805) 95 Total intangible assets $ 52,950 $ (16,247) $ 36,703 |
Notes Payable
Notes Payable | 9 Months Ended |
Sep. 30, 2019 | |
Debt Disclosure [Abstract] | |
Notes Payable | Notes payable: 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 $60.0 million (the “Term Loan”), with the ability to draw an additional $20.0 million within twelve months of the closing date. The Loan Agreement replaced the Company’s previous Term Loan Agreement (the “Original Loan Agreement”) with CRG Servicing LLC (“CRG”). The Company utilized $60.0 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 nine months ended September 30, 2019, the Company expensed one-time events 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 on the first day for the quarter (LIBOR effective rate as of July 1, 2019 was 2.33%.) The Term Loan is subject to mandatory prepayment provisions that require prepayment upon change of control. The following table represents future maturities of the notes payable obligation as of September 30, 2019: 2019 — 2020 — 2021 — 2022 13,846 2023 18,462 2024 18,462 2025 9,230 Total maturities $ 60,000 Unamortized discount and loan costs (1,485) Total notes payable obligation $ 58,515 |
Net Sales by Product
Net Sales by Product | 9 Months Ended |
Sep. 30, 2019 | |
Segment Reporting [Abstract] | |
Net Sales by Product | 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 September 30, Nine months ended September 30, 2019 2018 2019 2018 BELBUCA $ 26,514 $ 12,358 $ 69,277 $ 30,128 Symproic 2,172 — 5,348 — BUNAVAIL 937 1,405 2,813 4,239 Net product sales $ 29,623 $ 13,763 $ 77,438 $ 34,367 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2019 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | Stockholders’ equity: 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. Common Stock On July 25, 2019, in connection with the Company’s 2019 Annual Meeting of Stockholders (“the Annual Meeting”), 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. Shareholders also 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. Stock-based compensation During the nine months ended September 30, 2019, a total of 2,267,904 options to purchase Common Stock, with an aggregate fair market value of approximately $9.5 million, were granted to employees, officers and directors of the Company. Options have a term of 10 years from the grant date. Options granted to employees vest ratably over a three 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 nine months ended September 30, 2019 follows: Expected price volatility 61.80%-64.10% Risk-free interest rate 1.36%-2.66% Weighted average expected life in years 6 years Dividend yield — Option activity during the nine months ended September 30, 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 1,132,109 3.93 Employees 1,135,795 4.46 Exercised (412,500) 4.60 Forfeitures (490,342) 3.97 Outstanding at September 30, 2019 5,771,066 $ 3.53 $ 5,627 As of September 30, 2019, options exercisable totaled 1,903,370. There are approximately $5.6 million of unrecognized compensation cost related to non-vested share-based compensation awards, including options and restricted stock units (“RSUs”) granted. These costs will be expensed through 2022. Restricted stock units During the nine months ended September 30, 2019, a cumulative total of 360,250 RSUs were granted to the Company’s executive officers, members of senior management, a former officer and directors with a fair market value of approximately $1.6 million. The fair value of restricted units is determined using quoted market prices of the Common Stock and the number of shares expected to vest. RSU grants are time-based, all of which generally vest from a one to three-year period. The RSU grant to the former officer vested on his retirement date April 30, 2019. Restricted stock activity during the nine months ended September 30, 2019 was as follows: Number of Weighted Outstanding at January 1, 2019 2,166,102 $ 2.59 Granted: Executive officers 223,250 4.44 Directors 90,000 4.85 Employees 47,000 4.67 Vested (801,661) 4.80 Forfeitures (87,132) 2.30 Outstanding at September 30, 2019 1,637,559 $ 3.23 Preferred Stock During the nine months ended September 30, 2019, 1,402 shares of Series B Preferred Stock (“Series B”) were converted into 7,788,888 shares of Common Stock. As of September 30, 2019, 1,698 shares of Series B are outstanding. As of September 30, 2019, 2,093,155 shares of Series A Preferred Stock (“Series A”) are outstanding. There were no conversions of Series A during the nine months ended September 30, 2019. Earnings Per Share Three months ended September 30, Nine months ended September 30, 2019 2018 2019 2018 Basic: Net income (loss) $ 354 $ (6,380) $ (14,609) $ (26,859) Less deemed dividend related to beneficial conversion feature on Series B Preferred Stock — (12,500) — (12,500) Net earnings (loss) attributable to common stockholders $ 354 $ (18,880) $ (14,609) $ (39,359) Weighted average common shares outstanding 89,649,922 64,900,007 81,612,112 60,599,456 Basic earnings (loss) per common share $ — $ (0.29) $ (0.18) $ (0.65) Diluted: Effect of dilutive securities: Net income (loss) attributable to common stockholders, diluted $ 354 $ (18,880) $ (14,609) $ (39,359) Weighted average common shares outstanding 89,649,922 64,900,007 81,612,112 60,599,456 Effect of dilutive options and warrants 15,488,972 — — — Dilutive weighted average common shares outstanding 105,138,894 64,900,007 81,612,112 60,599,456 Diluted earnings (loss) per common share $— $(0.29) $(0.18) $(0.65) During the three months ended September 30, 2019, outstanding stock options, RSUs, warrants and preferred shares of 15,488,972 were included in the computation of diluted earnings per common share. During the three months ended September 30, 2018, outstanding stock options, RSUs, warrants and preferred shares of 25,745,108 were not included in the computation |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 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. 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. 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 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 ® , 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 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 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. |
Organization, Basis of Presen_2
Organization, Basis of Presentation and Summary of Significant Policies (Policies) | 9 Months Ended |
Sep. 30, 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 conditions. The Company is utilizing its novel and proprietary BioErodible MucoAdhesive (BEMA) drug-delivery technology and other drug delivery technologies 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. In April 2019, the Company entered into an exclusive license agreement for the commercialization of Symproic (naldemedine tosylate) in the United States including Puerto Rico for opioid-induced constipation in adult patients with chronic non-cancer pain (Note 6). 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 for the year ended December 31, 2018. Certain footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to the Securities and Exchange Commission rules and regulations. It is recommended that these condensed consolidated financial statements be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s annual report on Form 10-K for the year ended December 31, 2018. Operating results for the three- and nine-month periods ended September 30, 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 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. |
Cash and cash equivalents | Cash and cash equivalents Cash and cash equivalents consist of operating and money market accounts. Cash equivalents are carried at cost which approximates fair value due to their short-term nature. The Company considers all highly-liquid investments with an original maturity of 90 days or less to be cash equivalents. |
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 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 $0.2 million for inventory obsolescence as of both September 30, 2019 and December 31, 2018. |
Revenue recognition | Revenue recognition 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. • Product royalty revenues- Product royalty revenue amounts are based on sales revenue of the PAINKYL product under the Company’s license agreement with TTY and the BREAKYL 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. 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. 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. 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. The Company has 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 |
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. Since April 2019, cost of sales has also included direct costs attributable to the production of Symproic. 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. |
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 September 30, 2019: Level 1 Level 2 Level 3 Balance at September 30, 2019 Cash and cash equivalents $ 55,863 — — $ 55,863 The cash and cash equivalent balance as of September 30, 2019 includes investments in various money market accounts and cash held in interest bearing accounts. |
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 nine months ended September 30, 2019. Research and development expense for the nine months ended September 30, 2018 totaled $4.0 million. |
Organization, Basis of Presen_3
Organization, Basis of Presentation and Summary of Significant Policies (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Accounting Policies [Abstract] | |
Fair Value, Assets Measured on Recurring Basis | The following table summarizes the cash and cash equivalents measured at fair value on a recurring basis as of September 30, 2019: Level 1 Level 2 Level 3 Balance at September 30, 2019 Cash and cash equivalents $ 55,863 — — $ 55,863 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Leases [Abstract] | |
Schedule of Components of Lease Expense | The components of lease expense were as follows: Three months ended September 30, Nine months ended September 30, 2019 2018 2019 2018 Lease Cost Operating lease cost Operating lease $ 82 $ 81 $ 246 $ 244 Variable lease costs 3 1 10 1 Total lease cost $ 85 $ 82 $ 256 $ 245 |
Schedule of Supplemental Cash Flow Information | Nine months ended September 30, 2019 2018 Other Information Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ 261 $ 245 Nine months ended September 30, 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 % |
Schedule of Future Minimum Lease Payments | Future minimum lease payments under non-cancellable leases as of September 30, 2019 were as follows: Maturity of Lease Liabilities 2019 $ 89 2020 360 2021 370 2022 219 Total lease payments $ 1,038 Less: Interest (152) Present value of lease liabilities $ 886 Components of Lease Assets and Liabilities September 30, Assets Property and equipment, net Operating lease-right of use asset $ 777 Liabilities Current liabilities Operating lease- current liability $ 271 Other long-term liabilities Operating lease- noncurrent liability 615 Total lease liabilities $ 886 |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Inventory Disclosure [Abstract] | |
Summary of Inventories | The following table represents the components of inventory as of: September 30, December 31, Raw materials & supplies $ 638 $ 645 Work-in-process 6,894 2,093 Finished goods 3,478 2,855 Obsolescence reserve (244) (187) Total inventories $ 10,766 $ 5,406 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Liabilities (Tables) | 9 Months Ended |
Sep. 30, 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: September 30, December 31, Accounts payable $ 2,175 $ 3,166 Accrued rebates 24,625 12,261 Accrued compensation and benefits 4,662 3,814 Accrued acquisition costs 9,970 318 Accrued returns 1,477 715 Accrued royalties 419 159 Accrued clinical trial costs — 464 Accrued legal 556 70 Accrued interest expense 1,508 — Accrued regulatory expenses 282 — Accrued other 871 572 Total accounts payable and accrued liabilities $ 46,545 $ 21,539 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Property, Plant and Equipment [Abstract] | |
Summarized Category of Fixed Assets | Property and equipment, summarized by major category, consist of the following as of: September 30, December 31, Machinery & equipment $ 5,635 $ 5,635 Right of use, building lease 777 — Computer equipment & software 437 406 Office furniture & equipment 161 155 Leasehold improvements 43 43 Idle equipment 679 679 Total 7,732 6,918 Less accumulated depreciation and amortization (4,019) (3,846) Total property and equipment, net $ 3,713 $ 3,072 |
License agreements and acquir_2
License agreements and acquired product rights (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Total Purchase Price Allocated To Acquired Asset Based On Relative Estimated Fair Values | 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 |
Other Intangible Assets (Tables
Other Intangible Assets (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Goodwill and Intangible Assets Disclosure [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: September 30, 2019 Gross Carrying Accumulated Intangible Assets, Product rights $ 6,050 $ (5,864) $ 186 BELBUCA license and distribution rights 45,000 (12,374) 32,626 Symproic license and distribution rights 30,636 (1,218) 29,418 Licenses 1,900 (1,875) 25 Total intangible assets $ 83,586 $ (21,331) $ 62,255 December 31, 2018 Gross Carrying Accumulated Intangible Assets, Product rights $ 6,050 $ (5,442) $ 608 BELBUCA license and distribution rights 45,000 (9,000) 36,000 Licenses 1,900 (1,805) 95 Total intangible assets $ 52,950 $ (16,247) $ 36,703 |
Notes Payable (Tables)
Notes Payable (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Debt Disclosure [Abstract] | |
Future Maturities of the Notes Payable Obligation | The following table represents future maturities of the notes payable obligation as of September 30, 2019: 2019 — 2020 — 2021 — 2022 13,846 2023 18,462 2024 18,462 2025 9,230 Total maturities $ 60,000 Unamortized discount and loan costs (1,485) Total notes payable obligation $ 58,515 |
Net Sales by Product (Tables)
Net Sales by Product (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Segment Reporting [Abstract] | |
Summary of Net Sales by Product | However, the following table presents net sales by product: Three months ended September 30, Nine months ended September 30, 2019 2018 2019 2018 BELBUCA $ 26,514 $ 12,358 $ 69,277 $ 30,128 Symproic 2,172 — 5,348 — BUNAVAIL 937 1,405 2,813 4,239 Net product sales $ 29,623 $ 13,763 $ 77,438 $ 34,367 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2019 | |
Stockholders' Equity Note [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 nine months ended September 30, 2019 follows: Expected price volatility 61.80%-64.10% Risk-free interest rate 1.36%-2.66% Weighted average expected life in years 6 years Dividend yield — |
Summary of Stock Option Activity | Option activity during the nine months ended September 30, 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 1,132,109 3.93 Employees 1,135,795 4.46 Exercised (412,500) 4.60 Forfeitures (490,342) 3.97 Outstanding at September 30, 2019 5,771,066 $ 3.53 $ 5,627 |
Summary of Restricted Stock Activity | Restricted stock activity during the nine months ended September 30, 2019 was as follows: Number of Weighted Outstanding at January 1, 2019 2,166,102 $ 2.59 Granted: Executive officers 223,250 4.44 Directors 90,000 4.85 Employees 47,000 4.67 Vested (801,661) 4.80 Forfeitures (87,132) 2.30 Outstanding at September 30, 2019 1,637,559 $ 3.23 |
Schedule of Earnings Per Share, Basic and Diluted | Three months ended September 30, Nine months ended September 30, 2019 2018 2019 2018 Basic: Net income (loss) $ 354 $ (6,380) $ (14,609) $ (26,859) Less deemed dividend related to beneficial conversion feature on Series B Preferred Stock — (12,500) — (12,500) Net earnings (loss) attributable to common stockholders $ 354 $ (18,880) $ (14,609) $ (39,359) Weighted average common shares outstanding 89,649,922 64,900,007 81,612,112 60,599,456 Basic earnings (loss) per common share $ — $ (0.29) $ (0.18) $ (0.65) Diluted: Effect of dilutive securities: Net income (loss) attributable to common stockholders, diluted $ 354 $ (18,880) $ (14,609) $ (39,359) Weighted average common shares outstanding 89,649,922 64,900,007 81,612,112 60,599,456 Effect of dilutive options and warrants 15,488,972 — — — Dilutive weighted average common shares outstanding 105,138,894 64,900,007 81,612,112 60,599,456 Diluted earnings (loss) per common share $— $(0.29) $(0.18) $(0.65) |
Organization, Basis of Presen_4
Organization, Basis of Presentation and Summary of Significant Policies - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Dec. 31, 2018 | |
Basis Of Presentation [Line Items] | |||||
Common Stock, par value (in usd per share) | $ 0.001 | $ 0.001 | $ 0.001 | ||
Preferred Stock, par value (in usd per share) | $ 0.001 | $ 0.001 | $ 0.001 | ||
Threshold Limit For Liquid Investments | 90 days | ||||
Inventory obsolescence reserved | $ 244,000 | $ 244,000 | $ 187,000 | ||
Discount for prompt payment | 2.00% | 2.00% | |||
Research and development expense | $ 0 | $ 699,000 | $ 0 | $ 4,038,000 | |
Minimum | |||||
Basis Of Presentation [Line Items] | |||||
Accrual to payment cycle period | 1 month | ||||
Maximum | |||||
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 - Cash and Cash Equivalents a Recurring Basis (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Cash and cash equivalents | $ 55,863 | $ 43,822 |
Fair Value, Inputs, Level 1 | ||
Cash and cash equivalents | $ 55,863 |
Leases - Schedule of Components
Leases - Schedule of Components of Lease Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Leases [Abstract] | ||||
Operating lease | $ 82 | $ 81 | $ 246 | $ 244 |
Variable lease costs | 3 | 1 | 10 | 1 |
Total lease cost | $ 85 | $ 82 | $ 256 | $ 245 |
Leases - Schedule of Supplement
Leases - Schedule of Supplemental Cash Flow Information (Detail) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2019 | Sep. 30, 2018 | |
Leases [Abstract] | ||
Operating cash flows from operating leases | $ 261 | $ 245 |
Weighted-average remaining lease term, operating leases | 3 years | 4 years |
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 | Sep. 30, 2019USD ($) |
Leases [Abstract] | |
2019 | $ 89 |
2020 | 360 |
2021 | 370 |
2022 | 219 |
Total lease payments | 1,038 |
Less: Interest | (152) |
Present value of lease liabilities | $ 886 |
Leases - Components of Lease (D
Leases - Components of Lease (Detail) $ in Thousands | Sep. 30, 2019USD ($) |
Assets | |
Property and equipment, net Operating lease-right of use asset | $ 777 |
Liabilities | |
Current liabilities Operating lease- current liability | 271 |
Other long-term liabilities Operating lease- noncurrent liability | 615 |
Total lease liabilities | $ 886 |
Inventory (Detail)
Inventory (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Inventory Disclosure [Abstract] | ||
Raw materials & supplies | $ 638 | $ 645 |
Work-in-process | 6,894 | 2,093 |
Finished goods | 3,478 | 2,855 |
Obsolescence reserve | (244) | (187) |
Total inventories | $ 10,766 | $ 5,406 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Payables and Accruals [Abstract] | ||
Accounts payable | $ 2,175 | $ 3,166 |
Accrued rebates | 24,625 | 12,261 |
Accrued compensation and benefits | 4,662 | 3,814 |
Accrued acquisition costs | 9,970 | 318 |
Accrued returns | 1,477 | 715 |
Accrued royalties | 419 | 159 |
Accrued clinical trial costs | 0 | 464 |
Accrued legal | 556 | 70 |
Accrued interest expense | 1,508 | 0 |
Accrued regulatory expenses | 282 | 0 |
Accrued other | 871 | 572 |
Total accounts payable and accrued liabilities | $ 46,545 | $ 21,539 |
Property and Equipment - Summar
Property and Equipment - Summarized Category of Fixed Assets (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Property, Plant and Equipment [Line Items] | ||
Property, plant & equipment, gross | $ 7,732 | $ 6,918 |
Less accumulated depreciation and amortization | (4,019) | (3,846) |
Total property and equipment, net | 3,713 | 3,072 |
Machinery and Equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant & equipment, gross | 5,635 | 5,635 |
Right of use, building lease | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant & equipment, gross | 777 | 0 |
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 | 161 | 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 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation | $ 80 | $ 200 | $ 200 | $ 700 |
License agreements and acquir_3
License agreements and acquired product rights - Total Purchase Price Allocated To Acquired Asset Based On Relative Estimated Fair Values (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Intangible assets | $ 62,255 | $ 36,703 |
Shiongi License And Supply Agreement | ||
Intangible assets | 30,636 | |
Symproic License | Shiongi License And Supply Agreement | ||
Intangible assets | 30,000 | |
Transaction Expense | Shiongi License And Supply Agreement | ||
Intangible assets | $ 636 |
License Agreements and Acquir_4
License Agreements and Acquired Product Rights - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Apr. 04, 2019 | |
Indefinite-lived Intangible Assets [Line Items] | |||||
Product samples purchased | $ 23,360 | $ 13,489 | $ 62,304 | $ 41,013 | |
Shiongi License And Supply Agreement | Symproic License | |||||
Indefinite-lived Intangible Assets [Line Items] | |||||
Upfront payment first installment to be made | $ 20,000 | ||||
Upfront payment installment henceforth to be made | $ 10,000 | ||||
Product samples purchased | $ 400 | ||||
Shiongi License And Supply Agreement | Symproic License | Additional Royalty As A Percentage | |||||
Indefinite-lived Intangible Assets [Line Items] | |||||
Tiered royalty payment as a percentage of sales | 1.00% | ||||
Shiongi License And Supply Agreement | Royalty Agreement Terms | Symproic License | Maximum | |||||
Indefinite-lived Intangible Assets [Line Items] | |||||
Tiered royalty payment as a percentage of sales | 17.50% | ||||
Shiongi License And Supply Agreement | Royalty Agreement Terms | Symproic License | Minimum | |||||
Indefinite-lived Intangible Assets [Line Items] | |||||
Tiered royalty payment as a percentage of sales | 8.50% |
Other Intangible Assets (Detail
Other Intangible Assets (Detail) - USD ($) $ in Thousands | Sep. 30, 2019 | Dec. 31, 2018 |
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | $ 83,586 | $ 52,950 |
Accumulated Amortization | 21,331 | 16,247 |
Intangible Assets, net | 62,255 | 36,703 |
Product Rights | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 6,050 | 6,050 |
Accumulated Amortization | 5,864 | 5,442 |
Intangible Assets, net | 186 | 608 |
License and Distribution Rights | BELBUCA | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 45,000 | 45,000 |
Accumulated Amortization | 12,374 | 9,000 |
Intangible Assets, net | 32,626 | 36,000 |
License and Distribution Rights | Symproic | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 30,636 | |
Accumulated Amortization | 1,218 | |
Intangible Assets, net | 29,418 | |
Licenses | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 1,900 | 1,900 |
Accumulated Amortization | 1,875 | 1,805 |
Intangible Assets, net | $ 25 | $ 95 |
Notes Payable - Future Maturiti
Notes Payable - Future Maturities of the CRG Obligation (Detail) - CRG - Line of Credit $ in Thousands | Sep. 30, 2019USD ($) |
Debt Instrument [Line Items] | |
2019 | $ 0 |
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 | (1,485) |
Total notes payable obligation | $ 58,515 |
Notes Payable - Additional Info
Notes Payable - Additional Information (Detail) - USD ($) | May 23, 2019 | Sep. 30, 2019 |
Debt Instrument [Line Items] | ||
Interest only, payment term | 36 months | |
CRG Servicing LLC Agreement | ||
Debt Instrument [Line Items] | ||
Back end facility fee | $ 5,600,000 | |
Bio Pharma Credit Plc | ||
Debt Instrument [Line Items] | ||
Secured credit term loan | 60,000,000 | |
Additional facility funds that can be obtained | 20,000,000 | |
Initial proceeds of term loan | 60,000,000 | |
Additional proceeds from debt | $ 1,800,000 | |
Bio Pharma Credit Plc | London Interbank Offered Rate (LIBOR) | ||
Debt Instrument [Line Items] | ||
Debt instrument, term | 72 months | |
Basis spread on variable rate | 7.50% | |
Line of Credit | CRG Servicing LLC Agreement | Interest Expense | ||
Debt Instrument [Line Items] | ||
Deferred loan costs | $ 5,200,000 | |
Debt instrument, unamortized discount | 3,900,000 | |
Loan prepayment fees and realized losses | $ 2,800,000 |
Net Sales by Product (Detail)
Net Sales by Product (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Sales Information [Line Items] | ||||
Net product sales | $ 30,306 | $ 14,156 | $ 79,752 | $ 37,611 |
BELBUCA | ||||
Sales Information [Line Items] | ||||
Net product sales | 26,514 | 12,358 | 69,277 | 30,128 |
Symproic | ||||
Sales Information [Line Items] | ||||
Net product sales | 2,172 | 0 | 5,348 | 0 |
BUNAVAIL | ||||
Sales Information [Line Items] | ||||
Net product sales | 937 | 1,405 | 2,813 | 4,239 |
Product sales | ||||
Sales Information [Line Items] | ||||
Net product sales | $ 29,623 | $ 13,763 | $ 77,438 | $ 34,367 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Apr. 15, 2019 | Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | Jul. 25, 2019 | Dec. 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 | $ 5,600 | $ 5,600 | |||||
Unrecognized compensation cost related to non-vested share-based compensation awards granted year | 2022 | ||||||
Stock option exercisable (in shares) | 1,903,370 | 1,903,370 | |||||
Proceeds from issuance common stock before underwriters discounts and commissions and offering expenses | $ 50,000 | ||||||
Proceeds from issuance common stock net of underwriters discounts and commissions and offering expenses | 47,600 | ||||||
Gross proceeds to selling stockholder from public offering | $ 19,000 | $ 48,000 | $ 0 | ||||
Stock options granted to underwriters vesting period | 30 days | ||||||
Common Stock, shares authorized (in shares) | 175,000,000 | 175,000,000 | 125,000,000 | ||||
Common stock, capital shares reserved for future issuance (in shares) | 14,000,000 | ||||||
Series B issuance, net of issuance costs (in shares) | 12,000,000 | ||||||
Sale of stock, price per share (in dollars per share) | $ 5 | ||||||
Sale of stock, number of shares issued in transaction (in shares) | 10,000,000 | ||||||
Antidilutive shares excluded from the computation of diluted earnings per common share (in shares) | 15,488,972 | 25,745,108 | 15,260,949 | 18,917,774 | |||
IPO | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock options granted to underwriters number of shares in grant after underwriter expenses (in shares) | 1,800,000 | ||||||
Restricted Stock Units (RSUs) | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of equity instruments awarded in period (in shares) | 360,250 | ||||||
Vesting period of shares | 3 years | ||||||
Fair market value of RSUs granted | $ 1,600 | ||||||
Series B Preferred Stock | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Conversion of Series A preferred stock (in shares) | (18) | (1,900) | (1,402) | (1,900) | |||
Series A preferred shares outstanding (in shares) | 1,698 | 1,698 | 3,100 | ||||
Series B issuance, net of issuance costs (in shares) | 5,000 | ||||||
Series A Preferred Stock | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Series A preferred shares outstanding (in shares) | 2,093,155 | 2,093,155 | 2,093,155 | ||||
Series B issuance, net of issuance costs (in shares) | 0 | ||||||
Common Stock | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Conversion of Series A preferred stock (in shares) | 100,000 | 10,555,556 | 7,788,888 | 10,555,556 | |||
Board of Directors and Employee | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of equity instruments awarded in period (in shares) | 2,267,904 | ||||||
Fair market value of shares granted | $ 9,500 | ||||||
Term of options granted period | 10 years | ||||||
Employees | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting period of shares | 3 years | ||||||
Employees | Restricted Stock Units (RSUs) | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Number of equity instruments awarded in period (in shares) | 47,000 | ||||||
Board of Director | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Vesting period of shares, description | Board of Directors vest ratably through 2022 |
Stockholders' Equity - Key Assu
Stockholders' Equity - Key Assumptions Used in Determining Fair Value of Options Granted (Detail) | 9 Months Ended |
Sep. 30, 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 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Expected price volatility | 61.80% |
Risk-free interest rate | 1.36% |
Maximum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Expected price volatility | 64.10% |
Risk-free interest rate | 2.66% |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Stock Option Activity (Detail) $ / shares in Units, $ in Thousands | 9 Months Ended | |
Sep. 30, 2019USD ($)$ / sharesshares | Dec. 31, 2018USD ($) | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding at beginning of period (in shares) | shares | 4,406,004 | |
Exercised (in shares) | shares | (412,500) | |
Forfeitures (in shares) | shares | (490,342) | |
Outstanding at end of period (in shares) | shares | 5,771,066 | |
Weighted average exercise price per share, Outstanding at beginning of period (in usd per share) | $ / shares | $ 3.19 | |
Weighted average exercise price per share, Exercised (in usd per share) | $ / shares | 4.60 | |
Weighted average exercise price per share, Forfeitures (in usd per share) | $ / shares | 3.97 | |
Weighted average exercise price per share, Outstanding at end of period (in usd per share) | $ / shares | $ 3.53 | |
Aggregate intrinsic value, Outstanding, balance | $ | $ 5,627 | $ 4,172 |
Officers and Directors | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Granted (in shares) | shares | 1,132,109 | |
Weighted average exercise price per share, Granted (in usd per share) | $ / shares | $ 3.93 | |
Employees | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Granted (in shares) | shares | 1,135,795 | |
Weighted average exercise price per share, Granted (in usd per share) | $ / shares | $ 4.46 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Restricted Stock Activity (Detail) - Restricted Stock Units (RSUs) | 9 Months Ended |
Sep. 30, 2019$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Outstanding at beginning of period (in shares) | 2,166,102 |
Granted (in shares) | 360,250 |
Vested (in shares) | (801,661) |
Forfeitures (in shares) | (87,132) |
Outstanding at end of period (in shares) | 1,637,559 |
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 | $ 3.23 |
Executive Officers | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Granted (in shares) | 223,250 |
Weighted average fair market value per RSU, Granted (in usd per share) | $ / shares | $ 4.44 |
Employees | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Granted (in shares) | 47,000 |
Weighted average fair market value per RSU, Granted (in usd per share) | $ / shares | $ 4.67 |
Directors | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Granted (in shares) | 90,000 |
Weighted average fair market value per RSU, Granted (in usd per share) | $ / shares | $ 4.85 |
Stockholder's Equity - Schedule
Stockholder's Equity - Schedule of Earnings per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2019 | Sep. 30, 2018 | Sep. 30, 2019 | Sep. 30, 2018 | |
Stockholders' Equity Note [Abstract] | ||||
Net income (loss) | $ 354 | $ (6,380) | $ (14,609) | $ (26,859) |
Less deemed dividend related to beneficial conversion feature on Series B Preferred Stock | 0 | (12,500) | 0 | (12,500) |
Net income (loss) attributable to common stockholders | $ 354 | $ (18,880) | $ (14,609) | $ (39,359) |
Weighted average common stock shares outstanding, basic (in shares) | 89,649,922 | 64,900,007 | 81,612,112 | 60,599,456 |
Basic earnings (loss) per share (in usd per share) | $ 0 | $ (0.29) | $ (0.18) | $ (0.65) |
Net income (loss) | $ 354 | $ (18,880) | $ (14,609) | $ (39,359) |
Effect of dilutive options and warrants (in shares) | 15,488,972 | 0 | 0 | 0 |
Weighted average common stock shares outstanding, diluted (in shares) | 105,138,894 | 64,900,007 | 81,612,112 | 60,599,456 |
Diluted earnings (loss) per share (in usd per share) | $ 0 | $ (0.29) | $ (0.18) | $ (0.65) |