Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2020 | Aug. 05, 2020 | |
Cover [Abstract] | ||
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 | |
Title of 12(b) Security | Common stock, par value $0.001 | |
Trading Symbol | BDSI | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001103021 | |
Current Fiscal Year End Date | --12-31 | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2020 | |
Entity Tax Identification Number | 35-2089858 | |
Entity Incorporation, State or Country Code | DE | |
Entity File Number | 001-31361 | |
Entity common stock, shares outstanding (in shares) | 100,934,353 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 91,009 | $ 63,888 |
Accounts receivable, net | 48,126 | 38,790 |
Inventory, net | 17,774 | 11,312 |
Prepaid expenses and other current assets | 2,099 | 3,769 |
Total current assets | 159,008 | 117,759 |
Property and equipment, net | 1,508 | 2,075 |
Goodwill | 2,715 | 2,715 |
License and distribution rights, net | 56,842 | 60,309 |
Other intangible assets, net | 0 | 47 |
Total assets | 220,073 | 182,905 |
Current liabilities: | ||
Accounts payable and accrued liabilities | 56,646 | 53,993 |
Total current liabilities | 56,646 | 53,993 |
Notes payable, net | 78,274 | 58,568 |
Other long-term liabilities | 383 | 580 |
Total liabilities | 135,303 | 113,141 |
Commitments and contingencies (Note 9) | ||
Stockholders' equity: | ||
Preferred Stock, 5,000,000 shares authorized; Series A Non-Voting Convertible Preferred Stock. $0.001 par value, 0 and 2,093,155 shares outstanding at June 30, 2020 and December 31, 2019, respectively; Series B Non-Voting Convertible Preferred Stock, $0.001 par value, 443 and 618 shares outstanding at June 30, 2020 and December 31, 2019, respectively. | 0 | 2 |
Common Stock, $0.001 par value; 175,000,000 shares authorized at June 30, 2020 and December 31, 2019, respectively; 100,916,511 and 96,189,074 shares issued; 100,901,020 and 96,173,583 shares outstanding at June 30, 2020 and December 31, 2019, respectively. | 99 | 96 |
Additional paid-in capital | 445,180 | 436,306 |
Treasury stock, at cost,15,491 shares, as of June 30, 2020 and December 31, 2019. | (47) | (47) |
Accumulated deficit | (360,462) | (366,593) |
Total stockholders’ equity | 84,770 | 69,764 |
Total liabilities and stockholders’ equity | $ 220,073 | $ 182,905 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2020 | Dec. 31, 2019 |
Preferred Stock, par value (in usd per share) | $ 0.001 | |
Preferred Stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Common Stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Common Stock, shares authorized (in shares) | 175,000,000 | 175,000,000 |
Common Stock, shares issued (in shares) | 100,916,511 | 96,189,074 |
Common Stock, shares outstanding (in shares) | 100,901,020 | 96,173,583 |
Treasury stock, shares (in shares) | 15,491 | 15,491 |
Preferred Stock Series A | ||
Preferred Stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Preferred Stock, shares outstanding (in shares) | 0 | 2,093,155 |
Preferred Stock Series B | ||
Preferred Stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Preferred Stock, shares outstanding (in shares) | 443 | 618 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Revenues: | ||||
Total Revenues: | $ 36,582 | $ 29,677 | $ 74,861 | $ 49,446 |
Cost of sales | 5,435 | 4,923 | 10,995 | 8,975 |
Expenses: | ||||
Selling, general and administrative | 28,211 | 21,955 | 54,948 | 38,944 |
Total Expenses: | 28,211 | 21,955 | 54,948 | 38,944 |
Income from operations | 2,936 | 2,799 | 8,918 | 1,527 |
Interest expense, net | (1,693) | (13,937) | (2,987) | (16,498) |
Other income, net | 8 | 8 | 8 | 8 |
Income/(loss) before income taxes | 1,251 | (11,130) | 5,939 | (14,963) |
Income tax (provision)/recovery | (86) | 0 | 192 | 0 |
Net income/(loss) attributable to common stockholders | $ 1,165 | $ (11,130) | $ 6,131 | $ (14,963) |
Basic and diluted: | ||||
Weighted average common stock shares outstanding, basic (in shares) | 100,136,893 | 83,821,811 | 98,541,877 | 77,571,003 |
Basic earnings (loss) per share (in usd per share) | $ 0.01 | $ (0.13) | $ 0.06 | $ (0.19) |
Weighted average common stock shares outstanding, diluted (in shares) | 108,111,201 | 83,821,811 | 107,062,161 | 77,571,003 |
Diluted earnings (loss) per share (in usd per share) | $ 0.01 | $ (0.13) | $ 0.06 | $ (0.19) |
Product sales, net | ||||
Revenues: | ||||
Total Revenues: | $ 36,445 | $ 28,056 | $ 74,161 | $ 47,815 |
Product royalty revenues | ||||
Revenues: | ||||
Total Revenues: | 137 | 1,461 | 700 | 1,471 |
Contract revenues | ||||
Revenues: | ||||
Total Revenues: | $ 0 | $ 160 | $ 0 | $ 160 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Treasury Stock | Accumulated Deficit | Preferred Stock Series A | Preferred Stock Series APreferred Stock | Preferred Stock Series ACommon Stock | Preferred Stock Series AAdditional Paid-In Capital | Preferred Stock Series B | Preferred Stock Series BPreferred Stock | Preferred Stock Series BCommon Stock | Preferred Stock Series BAdditional Paid-In Capital |
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 | 2,711 | 2,711 | |||||||||||
Stock option exercises | 1,070 | 1,070 | |||||||||||
Stock option exercises (in shares) | 360,379 | ||||||||||||
Restricted stock awards | 0 | $ (1) | 1 | ||||||||||
Restricted stock awards (in shares) | 692,032 | ||||||||||||
Series B conversion to common stock | $ 0 | $ 8 | $ (8) | ||||||||||
Series B conversion to common stock (in shares) | 1,384 | 7,688,888 | |||||||||||
Equity offering, net of finance costs (in shares) | 10,000,000 | ||||||||||||
Equity offering, net of finance costs | 47,590 | $ 10 | 47,580 | ||||||||||
Net income | (14,963) | (14,963) | |||||||||||
Ending Balance at Jun. 30, 2019 | 66,150 | $ 88 | 432,358 | (47) | (366,251) | $ 2 | $ 0 | ||||||
Ending Balance (in shares) at Jun. 30, 2019 | 89,535,024 | 2,093,155 | 1,716 | ||||||||||
Beginning Balance at Mar. 31, 2019 | 27,522 | $ 74 | 382,614 | (47) | (355,121) | $ 2 | $ 0 | ||||||
Beginning Balance (in shares) at Mar. 31, 2019 | 75,333,254 | 2,093,155 | 2,400 | ||||||||||
Stock-based compensation | 1,570 | 1,570 | |||||||||||
Stock option exercises | 598 | 598 | |||||||||||
Stock option exercises (in shares) | 210,104 | ||||||||||||
Restricted stock awards | 0 | ||||||||||||
Restricted stock awards (in shares) | 191,666 | ||||||||||||
Series B conversion to common stock | 0 | $ 4 | (4) | ||||||||||
Series B conversion to common stock (in shares) | 684 | 3,800,000 | |||||||||||
Equity offering, net of finance costs (in shares) | 10,000,000 | ||||||||||||
Equity offering, net of finance costs | 47,590 | $ 10 | $ 47,580 | ||||||||||
Net income | (11,130) | (11,130) | |||||||||||
Ending Balance at Jun. 30, 2019 | 66,150 | $ 88 | 432,358 | (47) | (366,251) | $ 2 | $ 0 | ||||||
Ending Balance (in shares) at Jun. 30, 2019 | 89,535,024 | 2,093,155 | 1,716 | ||||||||||
Beginning Balance at Dec. 31, 2019 | 69,764 | $ 96 | 436,306 | (47) | (366,593) | $ 2 | $ 0 | ||||||
Beginning Balance (in shares) at Dec. 31, 2019 | 96,189,074 | 2,093,155 | 618 | ||||||||||
Stock-based compensation | 6,306 | 6,306 | |||||||||||
Stock option exercises | $ 2,569 | $ 0 | 2,569 | ||||||||||
Stock option exercises (in shares) | 1,090,724 | 1,090,724 | |||||||||||
Restricted stock awards | $ 0 | $ 0 | |||||||||||
Restricted stock awards (in shares) | 571,336 | ||||||||||||
Series B conversion to common stock | $ (1) | $ 2 | $ 2 | $ (1) | $ 1 | $ 1 | |||||||
Series B conversion to common stock (in shares) | 972,222 | (2,093,155) | 2,093,155 | 175 | 175 | 972,222 | |||||||
Equity offering, net of finance costs (in shares) | 0 | ||||||||||||
Net income | 6,131 | 6,131 | |||||||||||
Ending Balance at Jun. 30, 2020 | 84,770 | $ 99 | 445,180 | (47) | (360,462) | $ 0 | $ 0 | ||||||
Ending Balance (in shares) at Jun. 30, 2020 | 100,916,511 | 0 | 443 | ||||||||||
Beginning Balance at Mar. 31, 2020 | 76,588 | $ 99 | 438,163 | (47) | (361,627) | $ 0 | $ 0 | ||||||
Beginning Balance (in shares) at Mar. 31, 2020 | 99,821,408 | 0 | 443 | ||||||||||
Stock-based compensation | 4,786 | 4,786 | |||||||||||
Stock option exercises | 2,231 | $ 0 | 2,231 | ||||||||||
Stock option exercises (in shares) | 983,437 | ||||||||||||
Restricted stock awards | 0 | $ 0 | |||||||||||
Restricted stock awards (in shares) | 111,666 | ||||||||||||
Net income | 1,165 | 1,165 | |||||||||||
Ending Balance at Jun. 30, 2020 | $ 84,770 | $ 99 | $ 445,180 | $ (47) | $ (360,462) | $ 0 | $ 0 | ||||||
Ending Balance (in shares) at Jun. 30, 2020 | 100,916,511 | 0 | 443 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Operating activities: | ||
Net income/(loss) | $ 6,131 | $ (14,963) |
Adjustments to reconcile net income/(loss) to net cash flows from operating activities | ||
Depreciation | 446 | 168 |
Accretion of debt discount and loan costs | 142 | 11,374 |
Amortization of intangible assets | 3,515 | 3,187 |
Provision for inventory obsolescence | 72 | 149 |
Stock-based compensation expense | 6,306 | 2,711 |
Changes in assets and liabilities: | ||
Accounts receivable | (9,336) | (11,252) |
Inventories | (6,534) | (4,716) |
Prepaid expenses and other assets | 1,670 | (110) |
Accounts payable and accrued liabilities | 2,617 | 9,078 |
Taxes payable | (40) | 0 |
Net cash flows provided by/(used in) operating activities | 4,989 | (4,374) |
Investing activities: | ||
Product acquisitions | 0 | (20,674) |
Acquisitions of equipment | 0 | (79) |
Net cash flows used in investing activities | 0 | (20,753) |
Financing activities: | ||
Proceeds from issuance of common stock | 0 | 48,000 |
Equity issuance costs | 0 | (410) |
Proceeds from notes payable | 20,000 | 60,000 |
Proceeds from exercise of stock options | 2,569 | 1,070 |
Payment on note payable | 0 | (67,346) |
Loss on refinancing of former debt | 0 | (2,794) |
Payment on deferred financing fees | (437) | 0 |
Net cash flows provided by financing activities | 22,132 | 38,520 |
Net change in cash and cash equivalents | 27,121 | 13,393 |
Cash and cash equivalents at beginning of period | 63,888 | 43,822 |
Cash and cash equivalents at end of period | 91,009 | 57,215 |
Cash paid for interest | $ 3,095 | $ 3,831 |
Organization, Basis of Presenta
Organization, Basis of Presentation and Summary of Significant Policies | 6 Months Ended |
Jun. 30, 2020 | |
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 specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions. The Company has built a portfolio of products that includes utilizing its novel and proprietary BioErodible MucoAdhesive ("BEMA") drug-delivery technology to develop and commercialize new applications of proven therapies aimed at addressing important unmet medical needs. The Company commercializes its products in the U.S. using its own sales force while working in partnership with third parties to commercialize its products outside the U.S. 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, 2019 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, 2019. 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, 2019. 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”) and Arius Two, Inc. (“Arius Two”). All significant inter-company balances and transactions have been eliminated. Use of estimates in financial statements The preparation of the accompanying condensed consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the condensed 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 condensed 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 government program rebates, customer voucher redemptions, commercial contracts, rebates and chargebacks; sales returns reserves; sales bonuses; stock-based compensation; 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. Inventory obsolescence reserves at June 30, 2020 and December 31, 2019 were $0.5 million and $0.4 million, respectively. Revenue recognition The main types of revenue contracts are: • Product sales- Product sales amounts relate to sales of BELBUCA, Symproic and BUNAVAIL. In March 2020, the Company announced it will discontinue marketing of BUNAVAIL in 2020. 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. • 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. 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. Transaction price, including variable consideration Revenue from product sales is recorded at the net sales price, which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade discounts and allowances, product returns, government chargebacks, discounts and rebates, and other incentives, such as voucher programs, and other fee for service amounts that are detailed within contracts between the Company and its customers relating to the Company’s sale of its products. 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. Revenue from product sales is recorded after considering the impact of the following variable consideration amounts at the time of revenue recognition: 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. Government rebates and chargebacks- Government rebates and chargebacks include mandated discounts under Medicaid, Medicare, U.S Department of Veterans Affairs and other government agencies ("Government Payors"). The Company estimates the rebates and chargebacks to Government Payors based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. These reserves are recorded in the same period the revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included in accrued expenses and other current liabilities on the condensed consolidated balance sheets. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The Company estimates the rebates and chargebacks that it will provide to Government Payors based upon (i) the government-mandated discounts applicable to government-funded programs, (ii) information obtained from its customers and (iii) information obtained from other third parties regarding the payor mix for its products. The Company’s liability for these rebates consists of estimates of claims for the current quarter and estimated future claims that will be made for product shipments that have been recognized as revenue, but remain in the distribution channel inventories at the end of each reporting period. Commercial Contracts- The Company’s estimates of rebates arising from commercial contracts are based on its estimated mix of various third-party payers, which are contractually entitled to discounts from the Company’s listed prices of its products. If the mix across 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. Voucher program- The Company, from time to time, offers certain promotional product-related incentives to eligible patients. 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. Trade discounts and distribution fees- Trade discounts relate to prompt settlement discounts provided to customers. In addition, the Company compensates its customers for distribution of its products and data. The Company has determined that such services received to date are not distinct from its sale of products and may not reasonably represent fair value for these services. Therefore, estimates of these payments are recorded as a reduction of revenue based on contractual terms. Cost of sales Cost of sales includes the direct costs attributable to the production of BELBUCA, Symproic and BUNAVAIL. It includes raw materials, production costs at the Company’s contract manufacturing sites, quality testing directly related to the products, and depreciation on equipment that the Company has purchased to produce BELBUCA, Symproic and BUNAVAIL. It also includes the costs for any batches not meeting specifications and raw material yield losses. Yield losses and batches not meeting specifications are expensed as incurred. Cost of sales is recognized when sold to the wholesaler from our distribution center. For BREAKYL and PAINKYL (the Company’s out-licensed breakthrough cancer pain therapies), cost of sales includes all costs related to creating the product at the Company’s contract manufacturing location in Germany. The Company’s contract manufacturer bills the Company for the final product, which includes materials, direct labor costs, and certain overhead costs as outlined in applicable supply agreements. Cost of sales also includes royalty expenses that the Company owes to third parties. Recent accounting pronouncements-adopted Measurement of Credit Losses of Financial Instruments In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses of Financial Instruments; in November 2018 the FASB issued a subsequent amendment ASU No. 2018-19, Codification Improvements to Topic 326, Financial Instruments—Credit Losses; in April 2019 the FASB issued ASU No. 2019-04, Codification Improvements to Topic 326, Financial Instruments—Credit Losses. In May 2019 the FASB issued ASU No. 2019-05, Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief; and in November 2019 the FASB issued ASU No. 2019-11, Codification Improvements to Topic 326, Financial Instruments—Credit Losses. The new guidance changes the methodology for measuring credit losses on financial instruments and the timing of when such losses are recorded. In November 2019 the FASB issued ASU No. 2019-10, Financial Instruments—Credit Losses (Topic 326). The Company adopted Topic 326 during the six months ended June 30, 2020 and determined that the new guidance has no material impact on its condensed consolidated financial statements. The Company is exposed to credit losses primarily through its product sales. The Company assesses each counterparty’s ability to pay for the products it sells by conducting a credit review. The credit review considers the Company's expected billing exposure and timing for payment and the counterparty’s established credit rating or the Company's assessment of the counterparty’s creditworthiness based on the Company's analysis of their financial statements when a credit rating is not available. The Company also considers contract terms and conditions, and business strategy in its evaluation. A credit limit is established for each counterparty based on the outcome of this review. The Company monitors its ongoing credit exposure through active review of counterparty balances against contract terms and due dates. The Company's activities include timely account reconciliations, dispute resolution and payment confirmations. The Company may employ collection agencies and legal counsel to pursue recovery of defaulted receivables. As of June 30, 2020, the Company reported $47.5 million of trade receivables within accounts receivable. Based on an aging analysis at June 30, 2020, 91% of the Company's accounts receivable were outstanding less than 30 days. There was no change to the allowance for doubtful accounts and credit losses between June 30, 2020 or December 31, 2019. The Company writes off accounts receivable when management determines they are uncollectible and credits payments subsequently received on such receivables to bad debt expense in the period received. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement, which modifies the disclosure requirements on fair value measurements. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019 and early adoption is permitted. The new guidance does not have a material impact on its consolidated financial statements. In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606, which amends ASC 808 to clarify ASC 606 should apply in entirety to certain transactions between collaborative arrangement participants. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The Company has determined that the new guidance does not have a material impact on its consolidated financial statements. Recent accounting pronouncements-not yet adopted In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740)—Simplifying the Accounting for Income Taxes, which is intended to simplify accounting for income taxes. It removes certain exceptions to the general principles in Topic 740 and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020 and early adoption is permitted. The Company is currently evaluating but does not expect the new guidance to have a material impact on its consolidated financial statements. 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 financial instruments measured at fair value on a recurring basis as of June 30, 2020: Level 1 Level 2 Level 3 Balance at June 30, 2020 Cash and cash equivalents $ 91,009 $ — — $ 91,009 The cash and cash equivalent balance as of June 30, 2020 includes investments in various money market accounts and cash held in interest bearing accounts. |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2020 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory: The following table represents the components of inventory as of: June 30, December 31, Raw materials $ 3,947 $ 624 Work-in-process 8,277 6,198 Finished goods 6,005 4,874 Obsolescence reserve (455) (384) Total inventories $ 17,774 $ 11,312 |
Accounts Payable and Accrued Li
Accounts Payable and Accrued Liabilities | 6 Months Ended |
Jun. 30, 2020 | |
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: June 30, December 31, Accounts payable $ 13,289 $ 11,704 Accrued rebates 28,553 28,528 Accrued compensation and benefits 4,557 5,545 Accrued returns 7,014 4,438 Accrued royalties 648 535 Accrued legal 1,049 1,484 Accrued regulatory expenses 819 331 Accrued other 717 1,428 Total accounts payable and accrued liabilities $ 56,646 $ 53,993 |
Property and Equipment
Property and Equipment | 6 Months Ended |
Jun. 30, 2020 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment: Property and equipment, summarized by major category, consist of the following as of: June 30, December 31, Machinery & equipment $ 5,203 $ 5,635 Right of use, building lease 599 720 Computer equipment & software 385 437 Office furniture & equipment 174 174 Leasehold improvements 43 43 Idle equipment 679 679 Total 7,083 7,688 Less accumulated depreciation and amortization (5,575) (5,613) Total property and equipment, net $ 1,508 $ 2,075 Depreciation expense for the three-month periods ended June 30, 2020 and June 30, 2019, was approximately $0.4 million and $0.1 million, respectively. Depreciation expense for the six-month periods ended June 30, 2020 and June 30, 2019, was approximately $0.4 million and $0.2 million, respectively. Depreciation expense for the three and six-month periods ended June 30, 2020 includes a $0.3 million one-time charge due to BUNAVAIL equipment write-off. |
Intangible Assets
Intangible Assets | 6 Months Ended |
Jun. 30, 2020 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets | Intangible assets: Other intangible assets, net, consisting of product rights and licenses are summarized as follows: June 30, 2020 Gross Carrying Accumulated Intangible Assets, Product rights $ 6,050 $ (6,050) $ — BELBUCA license and distribution rights 45,000 (15,750) 29,250 Symproic license and distribution rights 30,636 (3,044) 27,592 Total intangible assets $ 81,686 $ (24,844) $ 56,842 December 31, 2019 Gross Carrying Accumulated Intangible Assets, Product rights $ 6,050 $ (6,003) $ 47 BELBUCA license and distribution rights 45,000 (13,500) 31,500 Symproic license and distribution rights 30,636 (1,827) 28,809 Total intangible assets $ 81,686 $ (21,330) $ 60,356 |
Notes Payable
Notes Payable | 6 Months Ended |
Jun. 30, 2020 | |
Debt Disclosure [Abstract] | |
Notes Payable | Notes payable: On May 23, 2019, the Company entered into a Loan Agreement (the “Loan Agreement”) with BPCR LIMITED PARTNERSHIP (the successor-in-interest to 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, which the Company drew down on May 22, 2020. The loan 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 April 1, 2020 was 2.00%.) The Term Loan is subject to mandatory prepayment provisions that require prepayment upon change of control. The debt balance has been categorized within Level 2 of the fair value hierarchy. The notes payable debt balance as of June 30, 2020 approximates its fair value based on prevailing interest rates as of the balance sheet date. The following table represents future maturities of the notes payable obligation as of June 30, 2020: 2020 — 2021 — 2022 18,462 2023 24,615 2024 24,615 2025 12,308 Total maturities $ 80,000 Unamortized discount and loan costs (1,726) Total notes payable obligation $ 78,274 |
Net Sales by Product
Net Sales by Product | 6 Months Ended |
Jun. 30, 2020 | |
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 June 30, Six months ended June 30, 2020 2019 2020 2019 BELBUCA $ 32,344 $ 24,060 $ 65,813 $ 42,763 % of net product sales 89 % 86 % 89 % 89 % Symproic 3,413 3,175 7,593 3,175 % of net product sales 9 % 11 % 10 % 7 % BUNAVAIL 688 821 755 1,877 % of net product sales 2 % 3 % 1 % 4 % Net product sales $ 36,445 $ 28,056 $ 74,161 $ 47,815 In March 2020 the company announced it will discontinue marketing of BUNAVAIL in the U.S. in 2020. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2020 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | Stockholders’ equity: Common Stock On July 23, 2020, in connection with the Company’s 2020 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 175,000,000 to 235,000,000. Stock-based compensation During the six months ended June 30, 2020, a total of 2,435,704 options to purchase Common Stock, with an aggregate fair market value of approximately $14.0 million, were granted to employees, officers, a director and the Interim Chief Executive Officer of the Company. Options have a term of 10 years from the grant date. Options granted to employees, officers and the director will vest ratably over a three-year period. Options granted to the Interim Chief Executive Officer in connection with his role as Interim Chief Executive Officer will vest upon certain performance milestones. Options previously granted to the former Chief Executive Officer vested upon his termination as Chief Executive Officer, and will be exercisable for a period of three years. (See Note 10, Commitments and Contingencies: Employment Agreement Termination and Release Agreement of Herm Cukier.) 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 six months ended June 30, 2020 follows: Expected price volatility 59.00%-61.76% Risk-free interest rate 0.43%-1.68% Weighted average expected life in years 6 years Dividend yield — Option activity during the six months ended June 30, 2020 was as follows: Number of Weighted average Aggregate Outstanding at January 1, 2020 5,496,971 $ 3.64 $ 15,455 Granted in 2020: Officers and Directors 1,234,988 5.84 Employees 1,200,716 5.66 Exercised (1,090,724) 2.36 Forfeitures (261,749) 5.13 Outstanding at June 30, 2020 6,580,202 $ 4.61 $ 3,359 As of June 30, 2020, options exercisable totaled 2,783,869. There are approximately $8.9 million of unrecognized compensation costs related to non-vested share-based compensation awards, including options and restricted stock units (“RSUs”) granted. These costs will be expensed through 2023. Restricted stock units During the six months ended June 30, 2020, a cumulative total of 269,769 RSUs were granted to the Company’s executive officers, a member of senior management, a director and the Interim Chief Executive Officer in connection with his role as Interim Chief Executive Officer with a fair market value of approximately $1.5 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 Restricted stock activity during the six months ended June 30, 2020 was as follows: Number of Weighted Outstanding at January 1, 2020 1,648,559 $ 3.86 Granted: Executive officers 241,314 5.52 Directors 16,000 4.46 Employees 12,455 5.52 Vested (571,336) 4.42 Forfeitures (407,217) 3.45 Outstanding at June 30, 2020 939,775 $ 3.74 Warrants The Company has granted warrants to purchase shares of Common Stock. Warrants may be granted to affiliates in connection with certain agreements. There were no warrants issued during the six months ended June 30, 2020 and as of June 30, 2020, a cumulative of 2,136,019 warrants remain outstanding. Preferred Stock During the six months ended June 30, 2020, 175 shares of Series B Preferred Stock (“Series B”) were converted into 972,222 shares of Common Stock. As of June 30, 2020, 443 shares of Series B are outstanding. During the six months ended June 30, 2020, 2,093,155 shares of Series A Preferred Stock (“Series A”) were converted on a one-for-one basis into shares of Common Stock. There are no remaining outstanding shares of Series A as of June 30, 2020. Earnings Per Share Three months ended June 30, Six months ended June 30, 2020 2019 2020 2019 Basic: Net income (loss) attributable to common stockholders, basic $ 1,165 $ (11,130) $ 6,131 $ (14,963) Weighted average common shares outstanding 100,136,893 83,821,811 98,541,877 77,571,003 Basic earnings (loss) per common share $ 0.01 $ (0.13) $ 0.06 $ (0.19) Diluted: Effect of dilutive securities: Net income (loss) attributable to common stockholders, diluted $ 1,165 $ (11,130) $ 6,131 $ (14,963) Weighted average common shares outstanding 100,136,893 83,821,811 98,541,877 77,571,003 Effect of dilutive options and warrants 7,974,308 — 8,520,284 — Dilutive weighted average common shares outstanding 108,111,201 83,821,811 107,062,161 77,571,003 Diluted earnings (loss) per common share $0.01 $(0.13) $0.06 $(0.19) During the three months ended June 30, 2020 and the six months ended June 30, 2020, outstanding stock options, RSUs, warrants and preferred shares of 7,974,308 and 8,520,284, respectively, were included in the computation of diluted earnings per common share. During the three months ended June 30, 2019 and the six months ended June 30, 2019, outstanding stock options, RSUs, warrants and preferred shares of 18,131,489 and 17,528,530 , respectively, were not included in the computation of diluted earnings per common share, because to do so would have had an antidilutive effect. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2020 | |
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. Employment Agreement Termination and Release Agreement of Herm Cukier In May 2020, the Company and Herm Cukier entered into a General Release Agreement (the “General Release Agreement”), relating to the termination of Mr. Cukier’s employment as Chief Executive Officer of the Company. In connection with the execution and delivery of the General Release Agreement, Herm Cukier was terminated as Chief Executive Officer and principal executive officer and resigned as a member of the Board of Directors of the Company, effective as of May 9, 2020 (the "Termination Date). Pursuant to the General Release Agreement, Mr. Cukier (i) received (a) a one-time payment of $1,217,438, which was equal to two times his annual base salary; (b) a one-time payment of $236,003, which was equal to his prorated 2020 bonus; (c) a one-time payment of $45,917 for unused paid time off; (d) a one-time payment of $2,360 for benefits and (e) a one-time payment of $100,338 in exchange for waiving the 60-day advance notice provision included in Mr. Cukier's original employment agreement and (ii) released the Company and its affiliates from certain claims. The one-time payments were made on June 1, 2020. All of Mr. Cukier’s outstanding option awards also became fully-vested and exercisable on the Termination Date. Appointment of Interim Chief Executive Officer Effective May 11, 2020, the Board of Directors (the “Board”) of the Company appointed Jeffrey Bailey as the Company’s Interim Chief Executive Officer. Mr. Bailey joined the Company in March 2020 as a member of the Board. Pursuant to an offer letter entered into between the Company and Mr. Bailey, dated May 10, 2020, Mr. Bailey will serve as Interim Chief Executive Officer for a period of up to six months. As Interim Chief Executive Officer, Mr. Bailey will be paid an annual base salary of $600,000 and will be eligible for a one-time bonus of $180,000 payable when a new chief executive officer commences employment with the Company. In connection with his appointment, Mr. Bailey was granted stock options to purchase 160,000 shares of the Company’s common stock, which will vest upon the achievement of certain performance milestones, and 40,000 restricted stock units, which will vest in equal installments over a two-year period beginning on May 11, 2021. Mr. Bailey will remain a member of the Board while serving as Interim Chief Executive Officer and will not receive any compensation for his service as a member of the Board during this time. 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 per disclosure requirements of the SEC. Additional details regarding the past procedural history of the matter can be found in the Company’s previously filed periodic filings with the SEC. Litigation related to BUNAVAIL On October 29, 2013, Reckitt Benckiser, Inc., Indivior, and Aquestive (collectively, the “RB Plaintiffs”) filed an action against the Company relating to its BUNAVAIL product in the United States District Court for the Eastern District of North Carolina (“EDNC”) for alleged patent infringement. BUNAVAIL is a drug approved for the maintenance treatment of opioid dependence. The RB Plaintiffs claim that the formulation for BUNAVAIL, which has never been disclosed publicly, infringes its US Patent No. 8,475,832 (the “‘832 Patent”). On May 21, 2014, the Court granted the Company’s motion to dismiss. On January 22, 2014, Aquestive initiated an inter partes review (“IPR”) on U.S. Patent No. 7,579,019, the (“‘019 Patent”). The PTAB upheld all claims of the Company’s ‘019 Patent in 2015 and this decision was not appealed by Aquestive. On September 20, 2014, the Company proactively filed a declaratory judgment action in the United States District Court for the EDNC requesting the Court to make a determination that the Company’s BUNAVAIL product does not infringe the ‘832 Patent, US Patent No. 7,897,080 (the “‘080 Patent”) and US Patent No. 8,652,378 (the “‘378 Patent”). The Company invalidated the “‘080 Patent” in its entirety in an inter partes reexamination proceeding. The Company invalidated all relevant claims of the ‘832 Patent in an IPR proceeding. And, in an IPR proceeding for the ‘378 Patent, in its decision not to institute the IPR proceeding, the PTAB construed the claims of the ‘378 Patent narrowly. Shortly thereafter, by joint motion of the parties, the ‘378 Patent was subsequently removed from the action. On June 6, 2016, in an unrelated case in which Indivior and Aquestive asserted the ‘832 Patent against other parties, the Delaware District Court entered an order invalidating other claims in the ‘832 Patent. Indivior and Aquestive cross-appealed all adverse findings in that decision to the Court of Appeals for the Federal Circuit in Case No. 17-2587. The Company’s declaratory judgment action remains stayed pending the outcome of that cross-appeal by Indivior and Aquestive. On September 22, 2014, the RB Plaintiffs filed an action against the Company (and the Company’s commercial partner) relating to the Company’s BUNAVAIL product in the United States District Court for the District of New Jersey for alleged patent infringement. The RB Plaintiffs claim that BUNAVAIL, whose formulation and manufacturing processes have never been disclosed publicly, infringes its patent U.S. Patent No. 8,765,167 (the “‘167 Patent”). The Company believes this is an anticompetitive attempt by the RB Plaintiffs to distract the Company’s efforts from commercializing BUNAVAIL. On December 12, 2014, the Company filed a motion to transfer the case from New Jersey to North Carolina and a motion to dismiss the case against its commercial partner. On October 28, 2014, the Company filed multiple IPR petitions on certain claims of the ‘167 Patent. The USPTO instituted three of the four IPR petitions. The PTAB upheld the claims and denied collateral estoppel applied to the PTAB decisions in March 2016. The Company appealed to Court of Appeals for the Federal Circuit. The USPTO intervened with respect to whether collateral estoppel applied to the PTAB. On June 19, 2018, the Company filed a motion to remand the case for further consideration by the PTAB in view of intervening authority. On July 31, 2018, the Federal Circuit vacated the decisions, and remanded the ‘167 Patent IPRs for further consideration on the merits. On February 7, 2019, the PTAB issued three decisions on remand purporting to deny institution of the three previously instituted IPRs of the ‘167 patent. On March 11, 2019, the Company timely appealed the PTAB decisions on remand to U.S. Court of Appeal for the Federal Circuit. On March 20, 2019, Aquestive and Indivior moved to dismiss the appeal, and the Company opposed that motion. On August 29, 2019, a three-judge panel of the Court of Appeals for the Federal Circuit granted the motion and dismissed the Company’s appeal. On September 30, 2019, the Company filed a petition for an en banc rehearing of the order dismissing the Company’s appeal by the full Federal Circuit Court of Appeals. On January 13, 2020, by the Court of Appeals for the Federal Circuit denied BDSI’s petition for en banc rehearing of the dismissal of BDSI’s appeal relating to inter partes review proceedings on the ’167 patent. On June 11, 2020, BDSI filed a petition for certiorari seeking U.S. Supreme Court review of the Federal Circuit’s decision. 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. The Court has scheduled a bench trial to commence on November 9, 2020 to adjudicate issues concerning the validity of the Orange Book patents listed for BELBUCA. 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, the “Chemo Defendants”), asserting that the Chemo 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 Court has scheduled a bench trial to commence on November 9, 2020 (jointly with Alvogen) to adjudicate issues concerning the validity of the Orange Book patents listed for BELBUCA. The Court has scheduled a bench trial to commence on May 3, 2021 to adjudicate issues concerning the Chemo Defendants’ infringement of the Orange Book patents. 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. On July 1, 2020, the Company filed its response to the Complaint and denied the claims asserted therein. The Company intends to defend against the litigation vigorously. On November 5, 2019, the Board determined that ratifying the declassification of the Board and the change in the voting standard as set forth in the Amendments, as well as ratifying the filing and effectiveness of the Amendments, is in the best interests of the Company and its stockholders. The Board thus approved resolutions ratifying such acts and the filing and effectiveness of the Amendments under Section 204 of the Delaware General Corporation Law. On July 23, 2020, the stockholders of the Company approved the ratification of the declassification of the Board and the change in the voting standard as set forth in the Amendments as well as the filing and effectiveness of the Amendments. On July 23, 2020, the Company filed a Certificate of Validation with the Delaware Secretary of State. |
Organization, Basis of Presen_2
Organization, Basis of Presentation and Summary of Significant Policies (Policies) | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
Overview | Overview BioDelivery Sciences International, Inc., together with its subsidiaries (collectively, the “Company”) is a rapidly growing specialty pharmaceutical company dedicated to patients living with serious and complex chronic conditions. The Company has built a portfolio of products that includes utilizing its novel and proprietary BioErodible MucoAdhesive ("BEMA") drug-delivery technology to develop and commercialize new applications of proven therapies aimed at addressing important unmet medical needs. The Company commercializes its products in the U.S. using its own sales force while working in partnership with third parties to commercialize its products outside the U.S. 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, 2019 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, 2019. 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, 2019. 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”) and Arius Two, Inc. (“Arius Two”). All significant inter-company balances and transactions have been eliminated. |
Use of estimates in financial statements | Use of estimates in financial statements The preparation of the accompanying condensed 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 condensed 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 condensed 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 government program rebates, customer voucher redemptions, commercial contracts, rebates and chargebacks; sales returns reserves; sales bonuses; stock-based compensation; 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. 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 | 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. Inventory obsolescence reserves at June 30, 2020 and December 31, 2019 were $0.5 million and $0.4 million, respectively. |
Revenue recognition | Revenue recognition The main types of revenue contracts are: • Product sales- Product sales amounts relate to sales of BELBUCA, Symproic and BUNAVAIL. In March 2020, the Company announced it will discontinue marketing of BUNAVAIL in 2020. 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. • 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. 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. Transaction price, including variable consideration Revenue from product sales is recorded at the net sales price, which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade discounts and allowances, product returns, government chargebacks, discounts and rebates, and other incentives, such as voucher programs, and other fee for service amounts that are detailed within contracts between the Company and its customers relating to the Company’s sale of its products. 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. Revenue from product sales is recorded after considering the impact of the following variable consideration amounts at the time of revenue recognition: 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. Government rebates and chargebacks- Government rebates and chargebacks include mandated discounts under Medicaid, Medicare, U.S Department of Veterans Affairs and other government agencies ("Government Payors"). The Company estimates the rebates and chargebacks to Government Payors based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. These reserves are recorded in the same period the revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included in accrued expenses and other current liabilities on the condensed consolidated balance sheets. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The Company estimates the rebates and chargebacks that it will provide to Government Payors based upon (i) the government-mandated discounts applicable to government-funded programs, (ii) information obtained from its customers and (iii) information obtained from other third parties regarding the payor mix for its products. The Company’s liability for these rebates consists of estimates of claims for the current quarter and estimated future claims that will be made for product shipments that have been recognized as revenue, but remain in the distribution channel inventories at the end of each reporting period. Commercial Contracts- The Company’s estimates of rebates arising from commercial contracts are based on its estimated mix of various third-party payers, which are contractually entitled to discounts from the Company’s listed prices of its products. If the mix across 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. Voucher program- The Company, from time to time, offers certain promotional product-related incentives to eligible patients. 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. Trade discounts and distribution fees- Trade discounts relate to prompt settlement discounts provided to customers. In addition, the Company compensates its customers for distribution of its products and data. The Company has determined that such services received to date are not distinct from its sale of products and may not reasonably represent fair value for these services. Therefore, estimates of these payments are recorded as a reduction of revenue based on contractual terms. |
Cost of sales | Cost of sales Cost of sales includes the direct costs attributable to the production of BELBUCA, Symproic and BUNAVAIL. It includes raw materials, production costs at the Company’s contract manufacturing sites, quality testing directly related to the products, and depreciation on equipment that the Company has purchased to produce BELBUCA, Symproic and BUNAVAIL. It also includes the costs for any batches not meeting specifications and raw material yield losses. Yield losses and batches not meeting specifications are expensed as incurred. Cost of sales is recognized when sold to the wholesaler from our distribution center. For BREAKYL and PAINKYL (the Company’s out-licensed breakthrough cancer pain therapies), cost of sales includes all costs related to creating the product at the Company’s contract manufacturing location in Germany. The Company’s contract manufacturer bills the Company for the final product, which includes materials, direct labor costs, and certain overhead costs as outlined in applicable supply agreements. Cost of sales also includes royalty expenses that the Company owes to third parties. |
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 financial instruments measured at fair value on a recurring basis as of June 30, 2020: Level 1 Level 2 Level 3 Balance at June 30, 2020 Cash and cash equivalents $ 91,009 $ — — $ 91,009 The cash and cash equivalent balance as of June 30, 2020 includes investments in various money market accounts and cash held in interest bearing accounts. |
Recent accounting pronouncements-adopted | Recent accounting pronouncements-adopted Measurement of Credit Losses of Financial Instruments In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses of Financial Instruments; in November 2018 the FASB issued a subsequent amendment ASU No. 2018-19, Codification Improvements to Topic 326, Financial Instruments—Credit Losses; in April 2019 the FASB issued ASU No. 2019-04, Codification Improvements to Topic 326, Financial Instruments—Credit Losses. In May 2019 the FASB issued ASU No. 2019-05, Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief; and in November 2019 the FASB issued ASU No. 2019-11, Codification Improvements to Topic 326, Financial Instruments—Credit Losses. The new guidance changes the methodology for measuring credit losses on financial instruments and the timing of when such losses are recorded. In November 2019 the FASB issued ASU No. 2019-10, Financial Instruments—Credit Losses (Topic 326). The Company adopted Topic 326 during the six months ended June 30, 2020 and determined that the new guidance has no material impact on its condensed consolidated financial statements. The Company is exposed to credit losses primarily through its product sales. The Company assesses each counterparty’s ability to pay for the products it sells by conducting a credit review. The credit review considers the Company's expected billing exposure and timing for payment and the counterparty’s established credit rating or the Company's assessment of the counterparty’s creditworthiness based on the Company's analysis of their financial statements when a credit rating is not available. The Company also considers contract terms and conditions, and business strategy in its evaluation. A credit limit is established for each counterparty based on the outcome of this review. The Company monitors its ongoing credit exposure through active review of counterparty balances against contract terms and due dates. The Company's activities include timely account reconciliations, dispute resolution and payment confirmations. The Company may employ collection agencies and legal counsel to pursue recovery of defaulted receivables. As of June 30, 2020, the Company reported $47.5 million of trade receivables within accounts receivable. Based on an aging analysis at June 30, 2020, 91% of the Company's accounts receivable were outstanding less than 30 days. There was no change to the allowance for doubtful accounts and credit losses between June 30, 2020 or December 31, 2019. The Company writes off accounts receivable when management determines they are uncollectible and credits payments subsequently received on such receivables to bad debt expense in the period received. In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement, which modifies the disclosure requirements on fair value measurements. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019 and early adoption is permitted. The new guidance does not have a material impact on its consolidated financial statements. In November 2018, the FASB issued ASU 2018-18, Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606, which amends ASC 808 to clarify ASC 606 should apply in entirety to certain transactions between collaborative arrangement participants. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The Company has determined that the new guidance does not have a material impact on its consolidated financial statements. Recent accounting pronouncements-not yet adopted In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740)—Simplifying the Accounting for Income Taxes, which is intended to simplify accounting for income taxes. It removes certain exceptions to the general principles in Topic 740 and amends existing guidance to improve consistent application. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020 and early adoption is permitted. The Company is currently evaluating but does not expect the new guidance to have a material impact on its consolidated financial statements. |
Organization, Basis of Presen_3
Organization, Basis of Presentation and Summary of Significant Policies (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
Fair Value, Assets Measured on Recurring Basis | The following table summarizes the financial instruments measured at fair value on a recurring basis as of June 30, 2020: Level 1 Level 2 Level 3 Balance at June 30, 2020 Cash and cash equivalents $ 91,009 $ — — $ 91,009 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Inventory Disclosure [Abstract] | |
Summary of Inventories | The following table represents the components of inventory as of: June 30, December 31, Raw materials $ 3,947 $ 624 Work-in-process 8,277 6,198 Finished goods 6,005 4,874 Obsolescence reserve (455) (384) Total inventories $ 17,774 $ 11,312 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
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: June 30, December 31, Accounts payable $ 13,289 $ 11,704 Accrued rebates 28,553 28,528 Accrued compensation and benefits 4,557 5,545 Accrued returns 7,014 4,438 Accrued royalties 648 535 Accrued legal 1,049 1,484 Accrued regulatory expenses 819 331 Accrued other 717 1,428 Total accounts payable and accrued liabilities $ 56,646 $ 53,993 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Property, Plant and Equipment [Abstract] | |
Summarized Category of Fixed Assets | Property and equipment, summarized by major category, consist of the following as of: June 30, December 31, Machinery & equipment $ 5,203 $ 5,635 Right of use, building lease 599 720 Computer equipment & software 385 437 Office furniture & equipment 174 174 Leasehold improvements 43 43 Idle equipment 679 679 Total 7,083 7,688 Less accumulated depreciation and amortization (5,575) (5,613) Total property and equipment, net $ 1,508 $ 2,075 |
Intangible Assets (Tables)
Intangible Assets (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
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: June 30, 2020 Gross Carrying Accumulated Intangible Assets, Product rights $ 6,050 $ (6,050) $ — BELBUCA license and distribution rights 45,000 (15,750) 29,250 Symproic license and distribution rights 30,636 (3,044) 27,592 Total intangible assets $ 81,686 $ (24,844) $ 56,842 December 31, 2019 Gross Carrying Accumulated Intangible Assets, Product rights $ 6,050 $ (6,003) $ 47 BELBUCA license and distribution rights 45,000 (13,500) 31,500 Symproic license and distribution rights 30,636 (1,827) 28,809 Total intangible assets $ 81,686 $ (21,330) $ 60,356 |
Notes Payable (Tables)
Notes Payable (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Debt Disclosure [Abstract] | |
Future Maturities of the Notes Payable Obligation | The following table represents future maturities of the notes payable obligation as of June 30, 2020: 2020 — 2021 — 2022 18,462 2023 24,615 2024 24,615 2025 12,308 Total maturities $ 80,000 Unamortized discount and loan costs (1,726) Total notes payable obligation $ 78,274 |
Net Sales by Product (Tables)
Net Sales by Product (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Segment Reporting [Abstract] | |
Summary of Net Sales by Product | However, the following table presents net sales by product: Three months ended June 30, Six months ended June 30, 2020 2019 2020 2019 BELBUCA $ 32,344 $ 24,060 $ 65,813 $ 42,763 % of net product sales 89 % 86 % 89 % 89 % Symproic 3,413 3,175 7,593 3,175 % of net product sales 9 % 11 % 10 % 7 % BUNAVAIL 688 821 755 1,877 % of net product sales 2 % 3 % 1 % 4 % Net product sales $ 36,445 $ 28,056 $ 74,161 $ 47,815 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
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 six months ended June 30, 2020 follows: Expected price volatility 59.00%-61.76% Risk-free interest rate 0.43%-1.68% Weighted average expected life in years 6 years Dividend yield — |
Summary of Stock Option Activity | Option activity during the six months ended June 30, 2020 was as follows: Number of Weighted average Aggregate Outstanding at January 1, 2020 5,496,971 $ 3.64 $ 15,455 Granted in 2020: Officers and Directors 1,234,988 5.84 Employees 1,200,716 5.66 Exercised (1,090,724) 2.36 Forfeitures (261,749) 5.13 Outstanding at June 30, 2020 6,580,202 $ 4.61 $ 3,359 |
Summary of Restricted Stock Activity | Restricted stock activity during the six months ended June 30, 2020 was as follows: Number of Weighted Outstanding at January 1, 2020 1,648,559 $ 3.86 Granted: Executive officers 241,314 5.52 Directors 16,000 4.46 Employees 12,455 5.52 Vested (571,336) 4.42 Forfeitures (407,217) 3.45 Outstanding at June 30, 2020 939,775 $ 3.74 |
Schedule of Earnings Per Share, Basic and Diluted | Three months ended June 30, Six months ended June 30, 2020 2019 2020 2019 Basic: Net income (loss) attributable to common stockholders, basic $ 1,165 $ (11,130) $ 6,131 $ (14,963) Weighted average common shares outstanding 100,136,893 83,821,811 98,541,877 77,571,003 Basic earnings (loss) per common share $ 0.01 $ (0.13) $ 0.06 $ (0.19) Diluted: Effect of dilutive securities: Net income (loss) attributable to common stockholders, diluted $ 1,165 $ (11,130) $ 6,131 $ (14,963) Weighted average common shares outstanding 100,136,893 83,821,811 98,541,877 77,571,003 Effect of dilutive options and warrants 7,974,308 — 8,520,284 — Dilutive weighted average common shares outstanding 108,111,201 83,821,811 107,062,161 77,571,003 Diluted earnings (loss) per common share $0.01 $(0.13) $0.06 $(0.19) |
Organization, Basis of Presen_4
Organization, Basis of Presentation and Summary of Significant Policies - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | |
Jun. 30, 2020 | Dec. 31, 2019 | |
Basis Of Presentation [Line Items] | ||
Common Stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Preferred Stock, par value (in usd per share) | $ 0.001 | |
Threshold limit for liquid investments | 90 days | |
Inventory obsolescence reserved | $ 455 | $ 384 |
Accounts receivable, after allowance for credit loss | $ 47,500 | |
Percent of accounts receivable outstanding for 30 days | 91.00% |
Organization, Basis of Presen_5
Organization, Basis of Presentation and Summary of Significant Policies - Cash and Cash Equivalents a Recurring Basis (Detail) $ in Thousands | Jun. 30, 2020USD ($) |
Cash and cash equivalents | $ 91,009 |
Fair Value, Inputs, Level 1 | |
Cash and cash equivalents | 91,009 |
Fair Value, Inputs, Level 2 | |
Cash and cash equivalents | 0 |
Fair Value, Inputs, Level 3 | |
Cash and cash equivalents | $ 0 |
Inventory (Detail)
Inventory (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 3,947 | $ 624 |
Work-in-process | 8,277 | 6,198 |
Finished goods | 6,005 | 4,874 |
Obsolescence reserve | (455) | (384) |
Total inventories | $ 17,774 | $ 11,312 |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Payables and Accruals [Abstract] | ||
Accounts payable | $ 13,289 | $ 11,704 |
Accrued rebates | 28,553 | 28,528 |
Accrued compensation and benefits | 4,557 | 5,545 |
Accrued returns | 7,014 | 4,438 |
Accrued royalties | 648 | 535 |
Accrued legal | 1,049 | 1,484 |
Accrued regulatory expenses | 819 | 331 |
Accrued other | 717 | 1,428 |
Total accounts payable and accrued liabilities | $ 56,646 | $ 53,993 |
Property and Equipment - Summar
Property and Equipment - Summarized Category of Fixed Assets (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||
Right of use, building lease | $ 599 | $ 720 |
Total | 7,083 | 7,688 |
Less accumulated depreciation and amortization | (5,575) | (5,613) |
Total property and equipment, net | 1,508 | 2,075 |
Machinery & equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant, and equipment, gross | 5,203 | 5,635 |
Computer equipment & software | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant, and equipment, gross | 385 | 437 |
Office furniture & equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant, and equipment, gross | 174 | 174 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant, and equipment, gross | 43 | 43 |
Idle equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant, and equipment, gross | $ 679 | $ 679 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Property, Plant and Equipment [Line Items] | ||||
Depreciation | $ 0.4 | $ 0.1 | $ 0.4 | $ 0.2 |
BUNAVAIL | ||||
Property, Plant and Equipment [Line Items] | ||||
Depreciation | $ 0.3 | $ 0.3 |
Intangible Assets (Detail)
Intangible Assets (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | $ 81,686 | $ 81,686 |
Accumulated Amortization | (24,844) | (21,330) |
Intangible Assets, net | 56,842 | 60,356 |
Product Rights | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 6,050 | 6,050 |
Accumulated Amortization | (6,050) | (6,003) |
Intangible Assets, net | 0 | 47 |
License and Distribution Rights | BELBUCA | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 45,000 | 45,000 |
Accumulated Amortization | (15,750) | (13,500) |
Intangible Assets, net | 29,250 | 31,500 |
License and Distribution Rights | Symproic | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 30,636 | 30,636 |
Accumulated Amortization | (3,044) | (1,827) |
Intangible Assets, net | $ 27,592 | $ 28,809 |
Notes Payable - Future Maturiti
Notes Payable - Future Maturities of the CRG Obligation (Detail) - CRG - Line of Credit $ in Thousands | Jun. 30, 2020USD ($) |
Debt Instrument [Line Items] | |
2020 | $ 0 |
2021 | 0 |
2022 | 18,462 |
2023 | 24,615 |
2024 | 24,615 |
2025 | 12,308 |
Total maturities | 80,000 |
Unamortized discount and loan costs | (1,726) |
Total notes payable obligation | $ 78,274 |
Notes Payable - Additional Info
Notes Payable - Additional Information (Detail) - USD ($) | Jan. 01, 2020 | Jun. 30, 2020 | May 23, 2019 |
Debt Instrument [Line Items] | |||
Interest only, payment term | 36 months | ||
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 | ||
Bio Pharma Credit Plc | London Interbank Offered Rate (LIBOR) | |||
Debt Instrument [Line Items] | |||
Debt instrument, term | 72 months | ||
Basis spread on variable rate | 2.00% | 7.50% |
Net Sales by Product (Detail)
Net Sales by Product (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Sales Information [Line Items] | ||||
Net product sales | $ 36,582 | $ 29,677 | $ 74,861 | $ 49,446 |
BELBUCA | ||||
Sales Information [Line Items] | ||||
Net product sales | $ 32,344 | $ 24,060 | $ 65,813 | $ 42,763 |
BELBUCA | Revenue Benchmark | Product Concentration Risk | ||||
Sales Information [Line Items] | ||||
Percent of net product sales | 89.00% | 86.00% | 89.00% | 89.00% |
Symproic | ||||
Sales Information [Line Items] | ||||
Net product sales | $ 3,413 | $ 3,175 | $ 7,593 | $ 3,175 |
Symproic | Revenue Benchmark | Product Concentration Risk | ||||
Sales Information [Line Items] | ||||
Percent of net product sales | 9.00% | 11.00% | 10.00% | 7.00% |
BUNAVAIL | ||||
Sales Information [Line Items] | ||||
Net product sales | $ 688 | $ 821 | $ 755 | $ 1,877 |
BUNAVAIL | Revenue Benchmark | Product Concentration Risk | ||||
Sales Information [Line Items] | ||||
Percent of net product sales | 2.00% | 3.00% | 1.00% | 4.00% |
Product sales, net | ||||
Sales Information [Line Items] | ||||
Net product sales | $ 36,445 | $ 28,056 | $ 74,161 | $ 47,815 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional information (Detail) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | Jul. 23, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Common Stock, shares authorized (in shares) | 175,000,000 | 175,000,000 | 175,000,000 | |||
Unrecognized compensation cost related to non-vested share-based compensation awards granted | $ 8.9 | $ 8.9 | ||||
Stock option exercisable (in shares) | 2,783,869 | 2,783,869 | ||||
Warrants outstanding (in shares) | 2,136,019 | 2,136,019 | ||||
Antidilutive shares excluded from the computation of diluted earnings per common share (in shares) | 7,974,308 | 18,131,489 | 8,520,284 | 17,528,530 | ||
Subsequent Event | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Common Stock, shares authorized (in shares) | 235,000,000 | |||||
Restricted Stock Units (RSUs) | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Number of equity instruments awarded in period (in shares) | 269,769 | |||||
Fair market value of RSUs granted | $ 1.5 | |||||
Restricted Stock Units (RSUs) | Minimum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period of shares | 1 year | |||||
Restricted Stock Units (RSUs) | Maximum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Vesting period of shares | 3 years | |||||
Preferred Stock Series B | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Conversion of Series A preferred stock (in shares) | 175 | |||||
Series A preferred shares outstanding (in shares) | 443 | 443 | 618 | |||
Preferred Stock Series A | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Series A preferred shares outstanding (in shares) | 0 | 0 | 2,093,155 | |||
Conversion of convertible preferred stock to common stock (in shares) | 2,093,155 | |||||
Series A 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) | 972,222 | |||||
Common Stock | Preferred Stock Series B | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Conversion of Series A preferred stock (in shares) | 3,800,000 | 972,222 | 7,688,888 | |||
Series A issuance, net of issuance costs (in shares) | 10,000,000 | 10,000,000 | ||||
Common Stock | Preferred Stock Series A | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Conversion of Series A preferred stock (in shares) | 2,093,155 | |||||
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) | 2,435,704 | |||||
Fair market value of shares granted | $ 14 | |||||
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) | 12,455 |
Stockholders' Equity - Key Assu
Stockholders' Equity - Key Assumptions Used in Determining Fair Value of Options Granted (Detail) | 6 Months Ended |
Jun. 30, 2020 | |
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 | 59.00% |
Risk-free interest rate | 0.43% |
Maximum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Expected price volatility | 61.76% |
Risk-free interest rate | 1.68% |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Stock Option Activity (Detail) $ / shares in Units, $ in Thousands | 6 Months Ended | |
Jun. 30, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($) | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Outstanding at beginning of period (in shares) | shares | 5,496,971 | |
Exercised (in shares) | shares | (1,090,724) | |
Forfeitures (in shares) | shares | (261,749) | |
Outstanding at end of period (in shares) | shares | 6,580,202 | |
Weighted average exercise price per share, Outstanding at beginning of period (in usd per share) | $ / shares | $ 3.64 | |
Weighted average exercise price per share, Exercised (in usd per share) | $ / shares | 2.36 | |
Weighted average exercise price per share, Forfeitures (in usd per share) | $ / shares | 5.13 | |
Weighted average exercise price per share, Outstanding at end of period (in usd per share) | $ / shares | $ 4.61 | |
Aggregate intrinsic value, Outstanding, balance | $ | $ 3,359 | $ 15,455 |
Officers and Directors | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Granted (in shares) | shares | 1,234,988 | |
Weighted average exercise price per share, Granted (in usd per share) | $ / shares | $ 5.84 | |
Employees | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Granted (in shares) | shares | 1,200,716 | |
Weighted average exercise price per share, Granted (in usd per share) | $ / shares | $ 5.66 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Restricted Stock Activity (Detail) - Restricted Stock Units (RSUs) | 6 Months Ended |
Jun. 30, 2020$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Outstanding at beginning of period (in shares) | 1,648,559 |
Granted (in shares) | 269,769 |
Vested (in shares) | (571,336) |
Forfeitures (in shares) | (407,217) |
Outstanding at end of period (in shares) | 939,775 |
Weighted average fair market value per RSU, Outstanding at beginning of period (in usd per share) | $ / shares | $ 3.86 |
Weighted average fair market value per RSU, Vested (in usd per share) | $ / shares | 4.42 |
Weighted average fair market value per RSU, Forfeitures (in usd per share) | $ / shares | 3.45 |
Weighted average fair market value per RSU, Outstanding at end of period (in usd per share) | $ / shares | $ 3.74 |
Executive Officers | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Granted (in shares) | 241,314 |
Weighted average fair market value per RSU, Granted (in usd per share) | $ / shares | $ 5.52 |
Employees | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Granted (in shares) | 12,455 |
Weighted average fair market value per RSU, Granted (in usd per share) | $ / shares | $ 5.52 |
Directors | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Granted (in shares) | 16,000 |
Weighted average fair market value per RSU, Granted (in usd per share) | $ / shares | $ 4.46 |
Stockholder's Equity - Schedule
Stockholder's Equity - Schedule of Earnings per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Stockholders' Equity Note [Abstract] | ||||
Net income (loss) attributable to common stockholders | $ 1,165 | $ (11,130) | $ 6,131 | $ (14,963) |
Weighted average common stock shares outstanding, basic (in shares) | 100,136,893 | 83,821,811 | 98,541,877 | 77,571,003 |
Basic earnings (loss) per share (in usd per share) | $ 0.01 | $ (0.13) | $ 0.06 | $ (0.19) |
Effect of dilutive options and warrants (in shares) | 7,974,308 | 0 | 8,520,284 | 0 |
Weighted average common stock shares outstanding, diluted (in shares) | 108,111,201 | 83,821,811 | 107,062,161 | 77,571,003 |
Diluted earnings (loss) per share (in usd per share) | $ 0.01 | $ (0.13) | $ 0.06 | $ (0.19) |
Commitments and Contingencies (
Commitments and Contingencies (Details) | Jun. 01, 2020USD ($)days | May 10, 2020USD ($)shares |
Ex Chief Executive Officer | ||
Restructuring Cost and Reserve [Line Items] | ||
Advance notice of provision | days | 60 | |
Chief Executive Officer | ||
Restructuring Cost and Reserve [Line Items] | ||
Granted (in shares) | shares | 160,000 | |
Chief Executive Officer | Restricted Stock | ||
Restructuring Cost and Reserve [Line Items] | ||
Restricted stock units granted (in shares) | shares | 40,000 | |
Vesting period of shares | 2 years | |
Special Termination Benefits, Annual Salary | Ex Chief Executive Officer | ||
Restructuring Cost and Reserve [Line Items] | ||
Payments for restructuring | $ 1,217,438 | |
Special Termination Benefits, Prorated Bonus | Ex Chief Executive Officer | ||
Restructuring Cost and Reserve [Line Items] | ||
Payments for restructuring | 236,003 | |
Special Termination Benefits, Unused PTO | Ex Chief Executive Officer | ||
Restructuring Cost and Reserve [Line Items] | ||
Payments for restructuring | 45,917 | |
Special Termination Benefits, Benefits | Ex Chief Executive Officer | ||
Restructuring Cost and Reserve [Line Items] | ||
Payments for restructuring | 2,360 | |
Special Termination Benefits, Prorated Bonus, Awards and Options | Ex Chief Executive Officer | ||
Restructuring Cost and Reserve [Line Items] | ||
Payments for restructuring | $ 100,338 | |
Employment Contract, Annual Salary | Chief Executive Officer | ||
Restructuring Cost and Reserve [Line Items] | ||
Payments for restructuring | $ 600,000 | |
Employment Contract, Bonus | Chief Executive Officer | ||
Restructuring Cost and Reserve [Line Items] | ||
Payments for restructuring | $ 180,000 |