Cover Page
Cover Page - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 07, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2021 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-31361 | ||
Entity Registrant Name | BioDelivery Sciences International, Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 35-2089858 | ||
Entity Address, Address Line One | 4131 ParkLake Avenue, Suite 225, | ||
Entity Address, City or Town | Raleigh | ||
Entity Address, State or Province | NC | ||
Entity Address, Postal Zip Code | 27612 | ||
City Area Code | 919 | ||
Local Phone Number | 582-9050 | ||
Title of 12(b) Security | Common stock, par value $0.001 | ||
Trading Symbol | BDSI | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 329,489,026 | ||
Entity Common Stock, Shares Outstanding (in shares) | 103,228,796 | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2021 | ||
Entity Central Index Key | 0001103021 | ||
Document Fiscal Period Focus | FY |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2021 | |
Audit Information [Abstract] | |
Auditor Name | Ernst & Young LLP |
Auditor Location | Raleigh, NC |
Auditor Firm ID | 42 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash | $ 114,300 | $ 111,584 |
Accounts receivable, net | 56,867 | 48,150 |
Inventory, net | 23,711 | 17,443 |
Prepaid expenses and other current assets | 7,178 | 5,208 |
Total current assets | 202,065 | 182,385 |
Property and equipment, net | 1,741 | 1,418 |
Goodwill | 2,715 | 2,715 |
License and distribution rights, net | 61,548 | 53,376 |
Deferred tax asset, net | 56,527 | 0 |
Total assets | 324,596 | 239,894 |
Current liabilities: | ||
Accounts payable and accrued liabilities | 77,763 | 52,995 |
Notes payable, current | 4,615 | 0 |
Total current liabilities | 82,378 | 52,995 |
Notes payable, less current maturities | 54,177 | 78,452 |
Other long-term liabilities | 219 | 213 |
Total liabilities | 136,774 | 131,660 |
Commitments and contingencies (Notes 8 and 14) | ||
Stockholders’ equity: | ||
Preferred Stock, 5,000,000 shares authorized; 2,714,300 shares issued; Series A Non-Voting Convertible Preferred Stock. $0.001 par value, 0 shares outstanding at both of December 31, 2021 and December 31, 2020; Series B Non-Voting Convertible Preferred Stock, $0.001 par value, 443 shares outstanding at both of December 31, 2021 and December 31, 2020. | 0 | 0 |
Common Stock, $.001 par value; 235,000,000 shares authorized at both of December 31, 2021 and December 31, 2020; 102,120,289 and 101,417,441 shares issued;98,854,605 and 101,354,447 shares outstanding at December 31, 2021 and December 31, 2020, respectively. | 104 | 104 |
Additional paid-in capital | 455,895 | 449,264 |
Treasury stock, at cost, 3,265,684 and 62,994 shares as of December 31, 2021 and December 31, 2020, respectively | (12,155) | (252) |
Accumulated deficit | (256,022) | (340,882) |
Total stockholders’ equity | 187,822 | 108,234 |
Total liabilities and stockholders’ equity | $ 324,596 | $ 239,894 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 2,714,300 | 2,714,300 |
Preferred stock, par value (in dollars per share) | $ 0.001 | |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 235,000,000 | 235,000,000 |
Common stock, shares issued (in shares) | 102,120,289 | 101,417,441 |
Common stock, shares outstanding (in shares) | 98,854,605 | 101,354,447 |
Treasury stock, shares (in shares) | 3,265,684 | 62,994 |
SeriesA Non-Voting Convertible Preferred Stock | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Series B Non-Voting Convertible Preferred Stock | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares outstanding (in shares) | 443 | 443 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Revenues: | |||
Revenues | $ 166,703 | $ 156,471 | $ 111,389 |
Cost of sales | 23,373 | 24,665 | 21,590 |
Expenses: | |||
Selling, general and administrative | 106,206 | 98,827 | 86,063 |
Total expenses | 106,206 | 98,827 | 86,063 |
Income from operations | 37,124 | 32,979 | 3,736 |
Interest expense, net of interest income | (7,496) | (7,013) | (19,040) |
Other (expense) income, net | (6) | (3) | 4 |
Income (loss) before taxes | 29,622 | 25,963 | (15,300) |
Income tax benefit (expense) | 55,238 | (252) | (5) |
Net income (loss) attributable to common stockholders | $ 84,860 | $ 25,711 | $ (15,305) |
Basic: | |||
Weighted average common stock shares outstanding (in shares) | 99,320,285 | 99,830,520 | 83,213,704 |
Basic income (loss) per share (in dollars per share) | $ 0.85 | $ 0.26 | $ (0.18) |
Diluted: | |||
Diluted weighted average common stock shares outstanding (in shares) | 103,292,988 | 105,062,522 | 83,213,704 |
Diluted income (loss) per share (in dollars per share) | $ 0.82 | $ 0.24 | $ (0.18) |
Product sales, net | |||
Revenues: | |||
Revenues | $ 164,598 | $ 154,574 | $ 107,888 |
Product royalty revenues | |||
Revenues: | |||
Revenues | 2,105 | 1,897 | 3,341 |
Contract revenue | |||
Revenues: | |||
Revenues | $ 0 | $ 0 | $ 160 |
Consolidated Statements of Stoc
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 B | Preferred Stock Series BPreferred Stock | Preferred Stock Series BCommon Stock | Preferred Stock Series BAdditional Paid-In Capital |
Beginning balance, preferred stock (in shares) at Dec. 31, 2018 | 2,093,155 | 3,100 | |||||||||
Beginning balance, common stock (in shares) at Dec. 31, 2018 | 70,793,725 | ||||||||||
Beginning balance at Dec. 31, 2018 | $ 29,742 | $ 71 | $ 381,004 | $ (47) | $ (351,288) | $ 2 | $ 0 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Stock-based compensation | 5,418 | 5,418 | |||||||||
Stock option exercises (in shares) | 799,800 | ||||||||||
Stock option exercises | 2,319 | 2,319 | |||||||||
Restricted stock awards (in shares) | 806,661 | ||||||||||
Restricted stock awards | $ 1 | (1) | |||||||||
Preferred stock conversion to common stock (in shares) | (2,482) | 13,788,888 | |||||||||
Preferred stock conversion to common stock | $ 14 | $ (14) | |||||||||
Equity offering, net of finance costs (in shares) | 10,000,000 | ||||||||||
Equity offering, net of finance costs | 47,590 | $ 10 | 47,580 | ||||||||
Net income (loss) | (15,305) | (15,305) | |||||||||
Ending balance, preferred stock (in shares) at Dec. 31, 2019 | 2,093,155 | 618 | |||||||||
Ending balance, common stock (in shares) at Dec. 31, 2019 | 96,189,074 | ||||||||||
Ending balance at Dec. 31, 2019 | 69,764 | $ 96 | 436,306 | (47) | (366,593) | $ 2 | $ 0 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Stock-based compensation | 9,595 | 9,595 | |||||||||
Stock option exercises (in shares) | 1,400,003 | ||||||||||
Stock option exercises | 3,370 | $ 1 | 3,369 | ||||||||
Restricted stock awards (in shares) | 762,987 | ||||||||||
Restricted stock awards | $ 4 | (4) | |||||||||
Preferred stock conversion to common stock (in shares) | (2,093,155) | (175) | 3,065,377 | ||||||||
Preferred stock conversion to common stock | $ (2) | $ (2) | $ 1 | $ 3 | $ (2) | ||||||
Share repurchase | (205) | (205) | |||||||||
Net income (loss) | $ 25,711 | 25,711 | |||||||||
Ending balance, preferred stock (in shares) at Dec. 31, 2020 | 0 | 0 | 443 | ||||||||
Ending balance, common stock (in shares) at Dec. 31, 2020 | 101,354,447 | 101,417,441 | |||||||||
Ending balance at Dec. 31, 2020 | $ 108,234 | $ 104 | 449,264 | (252) | (340,882) | $ 0 | $ 0 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||
Stock-based compensation | $ 6,168 | 6,168 | |||||||||
Stock option exercises (in shares) | 160,023 | 160,023 | |||||||||
Stock option exercises | $ 463 | 463 | |||||||||
Restricted stock awards (in shares) | 542,825 | ||||||||||
Share repurchase | (11,903) | (11,903) | |||||||||
Net income (loss) | $ 84,860 | 84,860 | |||||||||
Ending balance, preferred stock (in shares) at Dec. 31, 2021 | 0 | 443 | 443 | ||||||||
Ending balance, common stock (in shares) at Dec. 31, 2021 | 98,854,605 | 102,120,289 | |||||||||
Ending balance at Dec. 31, 2021 | $ 187,822 | $ 104 | $ 455,895 | $ (12,155) | $ (256,022) | $ 0 | $ 0 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Operating activities: | |||
Net income (loss) | $ 84,860 | $ 25,711 | $ (15,305) |
Adjustments to reconcile net income (loss) to net cash flows provided by (used in) operating activities | |||
Depreciation | 140 | 538 | 1,846 |
Accretion of debt discount and loan costs | 342 | 320 | 11,508 |
Amortization of intangible assets | 7,284 | 6,981 | 6,981 |
Provision for inventory obsolescence | 1,926 | 1,870 | 197 |
Deferred income taxes | (56,527) | 0 | 0 |
Net change in operating lease assets and liabilities | (376) | 0 | 0 |
Stock-based compensation expense | 6,168 | 9,595 | 5,416 |
Changes in assets and liabilities, net of effect of acquisition: | |||
Accounts receivable | (8,717) | (9,360) | (25,163) |
Inventories | (8,195) | (8,001) | (6,102) |
Prepaid expenses and other assets | (1,970) | (1,439) | (581) |
Accounts payable and accrued expenses | 16,102 | (1,234) | 32,275 |
Net cash flows provided by operating activities | 41,037 | 24,981 | 11,072 |
Investing activities: | |||
Product acquisitions | (6,457) | 0 | (30,685) |
Acquisitions of equipment | (415) | (13) | (79) |
Net cash flows used in investing activities | (6,872) | (13) | (30,764) |
Financing activities: | |||
Proceeds from exercise of stock options | 463 | 3,369 | 2,321 |
Proceeds from issuance of common stock, less underwriters discount | 0 | 0 | 48,000 |
Payment on note payable | (20,000) | 0 | (67,346) |
Proceeds from notes payable | 0 | 20,000 | 59,987 |
Equity finance costs | 0 | 0 | (410) |
Payment of deferred financing fees | 0 | (436) | 0 |
Loss on refinancing of former debt | 0 | 0 | (2,794) |
Payment on share repurchase | (11,903) | (205) | 0 |
Net cash flows (used in) provided by financing activities | (31,440) | 22,728 | 39,758 |
Net change in cash and cash equivalents | 2,725 | 47,696 | 20,066 |
Cash and cash equivalents at beginning of year | 111,584 | 63,888 | 43,822 |
Cash and cash equivalents at end of year | 114,309 | 111,584 | 63,888 |
Cash paid for interest | 7,191 | 6,979 | 6,809 |
Cash paid for income taxes | $ 1,415 | $ 250 | $ 0 |
Nature of Business and Summary
Nature of Business and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Nature of Business and Summary of Significant Accounting Policies | Nature of business and summary of significant accounting policies: Organization BioDelivery Sciences International, Inc. (the “Company”) was incorporated in the State of Indiana on January 6, 1997 and reincorporated as a Delaware corporation in 2002. The Company’s subsidiaries are Arius Pharmaceuticals, Inc., a Delaware corporation (“Arius One”) and Arius Two, Inc., a Delaware corporation (“Arius Two”), each of which are wholly-owned. The Company is a rapidly growing specialty pharmaceutical company working to deliver innovative therapies for individuals living with serious and debilitating chronic conditions. The Company has built a portfolio of products that includes utilizing its novel and proprietary BioErodible MucoAdhesive, or BEMA, drug-delivery technology to develop and commercialize new applications of proven therapies aimed at addressing important unmet medical needs. The Company commercializes 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. As used herein, the Company’s common stock, par value $0.001 per share, is referred to as the “Common Stock” and the Company’s preferred stock, par value $0.001 per share, is referred to as the “Preferred Stock”. Principles of consolidation The consolidated financial statements include the accounts of the Company, Arius One and Arius Two. All significant inter-company balances and transactions have been eliminated. Significant accounting policies: Use of estimates in financial statements The preparation of the accompanying consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the period. Actual results could differ from those estimates. The Company reviews all significant estimates affecting the consolidated financial statements on a recurring basis and records the effect of any necessary adjustments prior to their issuance. Significant estimates made by the Company include: revenue recognition associated with sales allowances such as government program rebates, customer voucher redemptions, commercial contracts, rebates and chargebacks; sales returns reserves; sales bonuses; stock-based compensation; and deferred income taxes. Concentration of risks Concentration of customers The following customers accounted for 10% or more of total net revenue for the years ended December 31, 2021, 2020 and 2019: Year Ended December 31, Customers 2021 2020 2019 % % % A 34% 33% 34% B 35% 34% 33% C 28% 27% 27% Concentration of suppliers The following suppliers accounted for 10% or more of inventory purchases for the years ended December 31, 2021, 2020. and 2019. Year Ended December 31, Suppliers 2021 2020 2019 $ $ $ A 15,045 17,429 8,142 B 4,362 3,756 1,755 C * 2,603 11,218 * Represents less than 10% of inventory purchases. Concentrations of credit risk 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 places cash on deposit with financial institutions in the United States that management believes are of high credit quality. The Federal Deposit Insurance Corporation ("FDIC") covers $0.25 million for substantially all depository accounts. The Company is exposed to credit risk in the event of default by the financial institution to the extent that cash and cash equivalent balances recorded in the balance sheets are in excess of the amounts that are insured by the FDIC. The Company has not experienced any losses on its deposits since inception, and management believes that minimal credit risk exists with respect to these financial institutions. Liquidity At December 31, 2021, the Company had cash of approximately $114.3 million. The Company generated $41.0 million of cash in operations during the year ended December 31, 2021 and had stockholders’ equity of $187.8 million, versus stockholders’ equity of $108.2 million at December 31, 2020. The Company believes that it has sufficient cash, along with expected proceeds from sales of BELBUCA and Symproic, to manage the business as currently planned. Additional capital may be required to support the continued commercialization of the Company's BELBUCA and Symproic products, the commercial launch of ELYXYB, or other products which may be acquired or licensed by the Company, and for general working capital requirements. Based on agreements with the Company's partners, the ability to scale up or reduce personnel and associated costs are factors considered throughout the product life cycle. Available resources may be consumed more rapidly than currently anticipated, potentially resulting in the need for additional funding. Accounts receivable The Company's accounts receivable balance consists of amounts due from product sales. Receivables are recorded net of allowances for trade discounts, distribution fees, prompt pay discounts, and doubtful accounts. The Company performs ongoing credit evaluations and does not require collateral. As appropriate, the Company establishes provisions for potential credit losses. The Company recorded $0.01 million in allowances for doubtful accounts as of December 31, 2021 and in 2020, respectively. The Company writes off accounts receivable when management determines they are uncollectible and credits payments subsequently received on such receivables to bad debt expense in the period received. Inventory Inventories are stated at the lower of cost or net realizable value with costs determined for each batch under the first-in, first-out method and specifically allocated to remaining inventory. Inventory consists of raw materials, work in process and finished goods. Raw materials include amounts of active pharmaceutical ingredient for a product to be manufactured, work in process includes the bulk inventory of laminate (the Company’s drug delivery film) prior to being packaged for sale, and finished goods include pharmaceutical products ready for commercial sale. On a quarterly basis, the Company analyzes its inventory levels and records allowances for inventory that has become obsolete, inventory that has a cost basis more than the expected net realizable value and inventory that is more than expected demand based upon projected product sales. The Company recorded $4.2 million and $2.3 million in reserves for inventory obsolescence as of December 31, 2021 and 2020, respectively. Inventory is composed of the following at December 31: 2021 2020 Raw Materials & Supplies $ 3,674 $ 3,389 Work-in-process 9,926 9,949 Finished Goods 14,291 6,359 Inventory Reserve (4,180) (2,254) Total Inventories $ 23,711 $ 17,443 Property and equipment The Company records property and equipment at cost less accumulated depreciation, which is computed on a straight-line basis over its estimated useful lives, generally 3 to 10 years. The Company evaluates the carrying value of equipment when events or changes in circumstances indicate the related carrying amount may not be recoverable. In connection with the discontinuation of the marketing of BUNAVAIL, the company recorded an additional $0.3 million and $1.5 million of depreciation related to certain equipment used in the production of BUNAVAIL, during 2020 and 2019, respectively. The Company has certain manufacturing equipment that isn’t currently in production, which has been deemed idle. The Company impaired certain obsolete office equipment totaling $0.3 million during the year ended December 31, 2020. There was no impairment of equipment recorded during the year ended 2021. Intangibles and goodwill The Company reviews intangible assets with finite lives (“other intangible assets”) for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company uses an estimate of the undiscounted cash flows over the remaining life of its other intangible assets, or related group of assets where applicable, in measuring whether the assets to be held and used will be realizable. In the event of impairment, the Company would discount the future cash flows using its then estimated incremental borrowing rate to estimate the amount of the impairment. There were no impairment charges recognized on finite lived intangibles in 2021, 2020 or 2019. Intangible assets with finite useful lives are amortized over the estimated useful lives as follows: Estimated Licenses 15 years BELBUCA license and distribution rights 10 years Symproic license and distribution rights 12 years ELYXYB product rights 15 years Goodwill is evaluated for impairment at least annually or more frequently if events or changes in circumstances indicate that the carrying amount may not be recoverable. During the evaluation of the potential impairment of goodwill, either a qualitative or a quantitative assessment may be performed. If a qualitative evaluation determines that it is more likely than not that no impairment exists, then no further analysis is performed. If a qualitative evaluation is unable to determine whether it is more likely than not that impairment has occurred, a quantitative evaluation is performed. If the carrying value exceeds the fair value, an impairment charge is recorded based on that difference. There were no goodwill impairment charges in 2021, 2020 or 2019. Revenue recognition The Company recognizes revenue in accordance with ASC, Topic 606, Revenue from Contracts with Customers ("ASC606"), which was adopted on January 1, 2018, using the modified retrospective transition method. Product sales Product sales amounts relate to sales of BELBUCA, Symproic and formerly BUNAVAIL. 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. The Company discontinued marketing of BUNAVAIL in June 2020. 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 including any associated financing component. 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 has determined that the delivery of its product to its customers constitutes a single performance obligation as there are no other promises to deliver goods or services. Shipping and handling activities are considered to be fulfillment activities and are not considered to be a separate performance obligation. The Company has assessed the existence of a significant financing component in the agreements with its customers. The trade payment terms with its customers do not exceed one year and therefore the Company has elected to apply the practical expedient and no amount of consideration has been allocated as a financing component. 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: • 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 third-party prescription data providers; • 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. In connection with the 2020 discontinuation of marketing of BUNAVAIL, the 2019 results included a reserve of $2.2 million for additional BUNAVAIL product returns. Subsequently, the majority of these reserves were released during 2020, as the Company did not experience an increase in the rate of returns following the discontinuation announcement, nor upon the actual discontinuation. 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 combination of historical experience, product pricing, estimated payor mix, product growth, and the mix of contract and agreement terms. 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. In addition, the pricing of covered products under Medicaid is subject to complex calculations and involves interpretation of government rules, regulations and policies as well as adjustments based on current trends in utilization. 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. Patient Assistance Voucher program- The Company, from time to time, offers certain promotional product-related incentives to eligible patients. The Company has voucher programs for BELBUCA and Symproic 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 the provision of 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. License and development agreements The Company periodically enters into license and development agreements to develop and commercialize its products. The arrangements typically are multi-deliverable arrangements that are funded through upfront payments, milestone payments and other forms of payment. The Company currently has license agreements that are described in note 7, of which these revenues are classified as contract revenue. Cost of sales Cost of sales includes the direct costs attributable to the production of BELBUCA, Symproic and formerly BUNAVAIL. It includes raw materials, production costs at the Company’s three contract manufacturing sites, quality testing directly related to the products, inventory reserves, and depreciation on equipment that the Company had purchased to produce BELBUCA, Symproic and formerly BUNAVAIL. It also includes any batches not meeting specifications and raw material yield losses. Yield losses and batches not meeting specifications are expensed as incurred. Cost of sales is recognized when sold to the wholesaler from our distribution center. For BREAKYL and PAINKYL (the Company’s out-licensed breakthrough cancer pain therapies), cost of sales includes all costs related to creating the product at the Company’s contract manufacturing location in Germany. The Company’s contract manufacturer bills the Company for the final product, which includes materials, direct labor costs, and certain overhead costs as outlined in applicable supply agreements. Cost of sales also includes royalty expenses that the Company owes to third parties. Advertising Advertising costs, which include promotional expenses and the cost of placebo samples, are expensed as incurred. Advertising expenses were $20.9 million, $11.0 million and $10.8 million for the years ended December 31, 2021, 2020 and 2019, respectively, and are included in selling, general and administrative expenses in the accompanying consolidated statements of operations. Shipping and handling costs Shipping and handling costs, which include expenses from our wholesalers, are expensed as incurred. Shipping and handling costs were $0.05 million, $0.03 million and $0.03 million for the years ended December 31, 2021, 2020 and 2019, respectively, and are included in selling, general and administrative expenses in the accompanying consolidated statements of operations. Stock-based compensation The Company has a stock-based compensation plan under which various types of equity-based awards are granted, including stock options, performance-based options, restricted stock units (RSUs) and performance-based RSUs. The fair value of stock option and RSUs, which are subject only to service conditions with graded vesting, are recognized as compensation expense, generally on a straight-line basis over the service period, net of estimated forfeitures. The fair values of performance-based options and RSUs are recognized as compensation expense beginning from when the performance is determined to be probable to the end of the performance period. The Company uses the fair-value based method to determine compensation for all arrangements under which employees and others receive shares of stock or equity instruments (warrants and options). The grant date fair value of an RSU equals the closing price of our common stock on the trading day of the grant date. The fair value of each option and warrant is estimated on the date of grant using the Black-Scholes valuation model that uses assumptions for expected volatility, expected dividends, expected term, and the risk-free interest rate. Expected volatility is based on historical volatility of the Company’s Common Stock and other factors estimated over the expected term of the options. The expected term of options granted is derived using the “simplified method” which computes expected term as the average of the sum of the vesting term plus the contract term. The risk-free rate is based on the U.S. Treasury yield. In applying the Black-Scholes options-pricing model, assumptions are as follows: 2021 2020 2019 Expected price volatility 53.70%-59.87% 59.00%-61.76% 61.66%-64.10% Risk-free interest rate 0.50%-1.38% 0.25%-1.68% 1.36%-2.66% Weighted average expected life in years 6 years 6 years 6 years Dividend yield — — — Fair Value of Financial Instruments The Company measures the fair value of instruments in accordance with GAAP which defines fair value, establishes a framework for measuring fair value, and expands disclosures about fair value measurements. GAAP defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. GAAP also establishes a fair value hierarchy, which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The Company considers the carrying amount of its cash and cash equivalents to approximate fair value due to short-term nature of this instrument. GAAP describes three levels of inputs that may be used to measure fair value: Level 1 – quoted prices in active markets for identical assets or liabilities Level 2 – quoted prices for similar assets and liabilities in active markets or inputs that are observable Level 3 – inputs that are unobservable (for example cash flow modeling inputs based on assumptions) The following table summarizes the cash and cash equivalents measured at fair value on a recurring basis as of December 31, 2021: Level 1 Level 2 Level 3 Balance at December 31, 2021 Cash and cash equivalents $ 114,309 — — $114,309 The cash and cash equivalent balance as of December 31, 2021 includes investments in various money market accounts and cash held in interest bearing accounts. Income Taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies in making that assessment. We recognize the effect of income tax positions only if those positions are more likely than not of being sustained. Recognized income tax positions are measured at the largest amount that is greater than 50% likely of being realized. Changes in recognition or measurement are reflected in the period in which the change in judgment occurs. Our policy for recording interest and penalties associated with audits is that penalties and interest expense are recorded in provision for income taxes in our statements of operations. The Company had no uncertain tax positions as of December 31, 2021 or December 31, 2020. Interest and, if applicable, penalties are recognized related to uncertain tax positions in income tax expense. There are no accruals for interest and penalties as of December 31, 2021. Measurement of credit losses of financial instruments 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 December 31, 2021, the Company reported $56.9 million of trade receivables within accounts receivable. Based on an aging analysis at December 31, 2021, 95% of the Company's accounts receivable were outstanding less than 30 days. 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. New Accounting Pronouncements 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 was permitted. The Company adopted Topic 740 during 2021 and determined that the new guidance did not have a material impact on its consolidated financial statements. The Company has reviewed other new accounting pronouncements that were issued as of December 31, 2021 and does not believe that these pronouncements are applicable to the Company, or that they will have a material impact on its financial position or results of operations. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Leases | Leases: The Company's corporate headquarters is located in Raleigh, North Carolina. The Company moved into its current headquarters in February 2015. The lease for this office, which commenced November 14, 2014 for 89 months, was extended in October 2021 for an additional 12 months. This space is approximately 12,000 square feet and has remaining base rent of $0.6 million payable through July 2023. Rent is payable in monthly installments and is subject to yearly price increases and increases for our share of common area maintenance costs. Variable Lease Costs Variable lease costs primarily include utilities, property taxes, and other operating costs that are passed on from the lessor. The components of lease expense were as follows: Year Ended December 31, 2021 2020 2019 Lease cost Operating lease cost Operating lease $ 336 $ 328 $ 328 Variable lease costs 34 19 13 Total lease cost $ 370 $ 347 $ 341 Supplemental cash flow information related to leases were as follows: Year Ended December 31, 2021 2020 2019 Other information Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ 370 $ 361 $ 351 Year Ended December 31, 2021 2020 Lease term and discount rate Weighted-average remaining lease term operating leases 2.0 years 2.0 years Weighted-average discount rate operating leases 11.8 % 11.8 % Maturity of Lease Liabilities Future minimum lease payments under non-cancellable leases as of December 31, 2021 were as follows: Maturity of lease liabilities 2022 $381 2023 226 Total lease payments 607 Less: Interest (52) Present value of lease liabilities $555 Components of Lease Assets and Liabilities December 31, 2021 Assets Property and equipment, net operating lease-right of use asset $ 520 Liabilities Current liabilities operating lease-current liability $ 336 Other long-term liabilities operating lease-noncurrent liability 219 Total lease liabilities $ 555 |
Accounts Payable and Accrued Li
Accounts Payable and Accrued Liabilities | 12 Months Ended |
Dec. 31, 2021 | |
Payables and Accruals [Abstract] | |
Accounts Payable and Accrued Liabilities | Accounts payable and accrued liabilities: The following table represents the components of accounts payable and accrued liabilities as of December 31: 2021 2020 Accounts payable $ 8,114 $ 4,213 Accrued rebates 38,681 34,247 Accrued compensation and benefits 6,097 5,488 Accrued returns 8,791 5,128 Accrued royalties 750 704 Taxes payable 666 1,026 Accrued regulatory fees 285 397 Accrued legal 2,394 515 Acquired product right 9,000 — Accrued other 2,985 1,277 Total accounts payable and accrued expenses $ 77,763 $ 52,995 As of December 31, 2021, three vendors comprised 64% of the accounts payable balance. As of December 31, 2020, three vendors comprised 55% of the accounts payable balance. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and equipment: Property and equipment, summarized by major category, consist of the following as of December 31: 2021 2020 Machinery & equipment $ 4,848 $ 4,683 Right of use, building and lease 520 471 Computer equipment & software 640 272 Office furniture & equipment 174 174 Leasehold improvements 43 43 Idle equipment 679 679 Construction in progress — 119 Total 6,904 6,441 Less accumulated depreciation (5,163) (5,023) Total property, plant & equipment, net $ 1,741 $ 1,418 |
Other Intangible Assets
Other Intangible Assets | 12 Months Ended |
Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Other Intangible Assets | Other intangible assets: Other intangible assets, net, consisting of product rights and licenses are summarized as follows: December 31, 2021 Gross Carrying Accumulated Intangible Assets, Remaining Weighted average BELBUCA license and distribution rights 45,000 (22,500) 22,500 5.3 Symproic license and distribution rights 30,636 (6,695) 23,941 10.3 ELYXYB product rights 15,456 (349) 15,107 14.5 Total intangible assets $ 91,092 $ (29,544) $ 61,548 8.5 December 31, 2020 Gross Carrying Accumulated Intangible Assets, Remaining Weighted average Product rights $ 6,050 $ (6,050) $ — BELBUCA license and distribution rights 45,000 (18,000) 27,000 6.0 Symproic license and distribution rights 30,636 (4,260) 26,376 10.8 Total intangible assets $ 81,686 $ (28,310) $ 53,376 7.9 The Company incurred amortization expense on other intangible assets of approximately $7.3 million, $7.0 million and $7.0 million for the years ended December 31, 2021, 2020 and 2019, respectively. Estimated aggregate future amortization expenses for other intangible assets for each of the next five years and thereafter are as follows: Years ending December 31, 2022 $ 7,982 2023 7,982 2024 7,982 2025 7,982 2026 7,982 Thereafter 21,636 Total amortization expense 61,548 |
License Agreements and Acquired
License Agreements and Acquired Product Rights | 12 Months Ended |
Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
License Agreements and Acquired Product Rights | License agreements and acquired product rights: Dr. Reddy’s acquired product rights On August 3, 2021, (the “DRL Effective Date”), the Company and Dr. Reddy’s Laboratories Limited, a company incorporated under the laws of India (“DRL”), entered into an asset purchase agreement (the “Asset Purchase Agreement”) for the acquisition by the Company from DRL of certain patents, trademarks, regulatory approvals and other rights related to ELYXYB™ (celecoxib oral solution) (the “Product”) and its commercialization in the United States and Canada (the “DRL Territory”). The closing of the transactions contemplated by the Asset Purchase Agreement occurred on September 9, 2021 (the "Closing"). Pursuant to the terms of the Asset Purchase Agreement, the Company paid DRL a $6 million up-front payment at the Closing. In addition, the Company will pay DRL $9 million on the twelve-month anniversary of the DRL Effective Date and up to an additional $9 million upon achievement of certain regulatory milestones and quarterly earn-out payments on potential sales of the Product in the DRL Territory that range from high single digits to the low double digits (subject to reduction in certain circumstances) of net sales based on volume of sales. DRL will also be entitled to one-time payments upon the achievement of six escalating sales milestones, which range from $4 million to be paid upon the achievement of $50 million in net sales in a calendar year to $100 million to be paid upon the achievement of $1 billion in net sales in a calendar year up to a total of $262 million. The Company accounted for the ELYXYB purchase as an asset acquisition under ASC 805-10-55-5b, which provides guidance for asset acquisitions. Under the guidance, if substantially all the acquisition is made up of one asset or several similar assets, then the acquisition is an asset acquisition. The Company believes that the asset purchase agreement and other assets acquired from DRL are similar and considers them all to be intangible assets. The total purchase price was allocated to the acquired asset based on their relative estimated fair values, as follows: ELYXYB acquired product rights $ 15,000 Transaction expenses 456 Total value $ 15,456 The $9 million twelve-month anniversary payment has been recorded in accounts payable and accrued liabilities in the accompanying consolidated balance sheet. Shionogi license and supply agreement On April 4, 2019 (the “Shionogi Effective Date”), the Company and Shionogi Inc. (“Shionogi”) entered into an exclusive license agreement (the “License Agreement”) for the commercialization of Symproic in the United States including Puerto Rico (the “Shionogi Territory”) for opioid-induced constipation in adult patients with chronic non-cancer pain (the “Shionogi Field”). Pursuant to the terms of the License Agreement, the Company paid Shionogi a $20 million up-front payment on the Effective Date and paid Shionogi a $10 million payment on the six-month anniversary of the Shionogi Effective Date (October 4, 2019), and quarterly, tiered royalty payments on potential sales of Symproic in the Shionogi Territory that range from 8.5% to 17.5% (plus an additional 1% of net sales on a pass-through basis to a third party licensor of Shionogi) of net sales based on volume of net sales and whether Symproic is being sold as an authorized generic. Assets acquired as part of the License Agreement include: intellectual property, inventory, trademarks and tradenames. The Company and Shionogi have made customary representations and warranties and have agreed to certain other customary covenants, including confidentiality, limitation of liability and indemnity provisions. Either party may terminate the License Agreement for cause if the other party materially breaches or defaults in the performance of its obligations. Unless earlier terminated, the License Agreement will continue in effect until the expiration of the Company’s royalty obligations, as defined. Upon expiration of the License Agreement, all licenses granted to Company for Symproic in the Shionogi Field and in the Shionogi Territory survive and become fully-paid, royalty-free, perpetual and irrevocable. The Company and Shionogi have also entered into a customary supply agreement under which Shionogi will supply Symproic to the Company at cost plus an agreed upon markup for an initial term of up to two years. In the event the Company elects to source Symproic from a third party supplier, Shionogi would continue to supply the Company with naldemedine tosylate for use in Symproic at cost plus such agreed upon markup for the duration of the License Agreement. The Company and Shionogi have also entered into a Pharmacovigilance agreement that required ongoing cooperation on adverse event reporting for the duration of License Agreement. The Company accounted for the Symproic purchase as an asset acquisition under ASC 805-10-55-5b, which provides guidance for asset acquisitions. Under the guidance, if substantially all the acquisition is made up of one asset or several similar assets, then the acquisition is an asset acquisition. The Company believes that the licensing agreement and other assets acquired from Shionogi are similar and consider them all to be intangible assets. The total purchase price was allocated to the acquired asset based on their relative estimated fair values, as follows: Symproic license $ 30,000 Transaction expenses 636 Total value $ 30,636 Additionally, the Company also purchased from Shionogi $0.4 million of Symproic samples, which have been recorded in selling, general and administrative expenses in the accompanying consolidated statement of operations for year ended December 31, 2019. |
License Agreements
License Agreements | 12 Months Ended |
Dec. 31, 2021 | |
Extractive Industries [Abstract] | |
License Agreements | License agreements: Mylan license and supply agreement In 2006, the Company announced collaboration with Meda AB, (which was acquired by Mylan N.V. "Mylan") to develop and commercialize BEMA Fentanyl (marketed as BREAKYL™ in Europe). Under terms of the agreement, the Company granted Mylan rights to the European development and commercialization of BREAKYL. Mylan managed the regulatory submission in Europe that led to approval in October 2010. In 2009, the Company amended the European agreement to provide Mylan the worldwide rights to ONSOLIS, except for South Korea and Taiwan. The sales royalties to be received by the Company are the same for all territories as agreed to for Europe. The Company received cumulative payments totaling $0.9 million, $0.8 million and $2.2 million, all which related to royalties based on product purchased by Mylan of BREAKYL. Such amounts are recorded as product royalty revenues in the accompanying consolidated statement of operations for the years ended December 31, 2021, 2020 and 2019, respectively. TTY license and supply agreement In 2010, the Company announced a license and supply agreement with TTY Biopharm Co., Ltd. (“TTY”) for the exclusive rights to develop and commercialize BEMA Fentanyl in the Republic of China, Taiwan. In 2013, the Company announced the regulatory approval of BEMA Fentanyl in Taiwan, where the product is now marketed under the brand name PAINKYL. The Company receives an ongoing royalty based on net sales. The term of the agreement with TTY is for the period from October 2010 until the date fifteen years after first commercial sale unless the agreement is extended in writing or earlier terminated as provided for in the agreement. The Company received cumulative payments totaling $1.2 million, $1.1 million and $1.2 million, all which related to royalties based on product purchased in Taiwan by TTY of PAINKYL. Such amounts are recorded as product royalty revenues in the accompanying consolidated statement of operations for the years ended December 31, 2021, 2020 and 2019, respectively. |
Notes Payable
Notes Payable | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Notes Payable | Notes payable: On May 23, 2019, the Company entered into a Loan Agreement (the “Loan Agreement”) with Biopharma Credit plc (“Pharmakon”), for a senior secured credit facility consisting of a term loan of $60 million (the “Term Loan”), with the ability to draw an additional $20 million within twelve months of the closing date, which the Company drew down on May 22. 2020. The Loan Agreement replaced the Company’s prior Term Loan Agreement (the “Original Loan Agreement”) with CRG Servicing LLC, ("CRG"). The Company utilized $60 million of the initial loan proceeds under the Loan Agreement, plus an additional $1.8 million to repay all of the outstanding loan balance owed by the Company under the Original Loan Agreement. The Company also used existing cash on hand to pay a $5.6 million backend facility fee to CRG. Upon the repayment of all amounts owed by the Company under the CRG Original Loan Agreement, all commitments to CRG were terminated and all security interests granted by the Company and its subsidiary guarantors under the CRG Original Loan Agreement were released. During the year ended December 31, 2019, the Company expensed one-time costs of $5.2 million in unamortized deferred loan fees, $3.9 million in unamortized warrant discount costs and $2.8 million in loan prepayment fees and realized losses arising out of the CRG Term Loan and recorded as interest expense in the accompanying consolidated statement of operations. The Term Loan 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, with a floor of 2% for the LIBOR rate (LIBOR effective rate as of October 1, 2021 was 0.13%). The Term Loan is subject to mandatory prepayment provisions that require prepayment upon change of control. On September 23, 2021, the Company elected to repay $20 million plus accrued interest of $1.5 million, representing a portion of the first tranche. The Term Loan includes the option for the Company to paydown up to $20 million of tranche A without incurring any prepayment penalties after the 24-month anniversary of the Term Loan. As a result, no prepayment penalty was incurred in connection with this prepayment. The obligations under the Term Loan Agreement are guaranteed by the Company’s subsidiaries and are secured by a first priority security interest in and a lien on substantially all of the assets of the Company and the subsidiary guarantors, subject to certain exceptions. The debt balance has been categorized within Level 2 of the fair value hierarchy. The notes payable debt balance 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 December 31, 2021: 2022 $ 4,615 2023 18,462 2024 24,615 2025 12,308 Total maturities $ 60,000 Unamortized discount and loan costs (1,208) Total notes payable obligation $ 58,792 |
Net Sales By Product
Net Sales By Product | 12 Months Ended |
Dec. 31, 2021 | |
Segment Reporting [Abstract] | |
Net Sales By Product | Net sales by product: The Company operates in a single industry engaging in the commercialization of pharmaceutical products for chronic conditions. Accordingly, the Company’s business is classified as a single reportable segment. The following table presents net sales by product for each of the years ended December 31: Year ended December 31, 2021 2020 2019 BELBUCA $ 148,189 $ 136,128 $ 97,538 % of net product sales 90.0 % 88.1 % 90.4 % Symproic 16,409 14,709 8,061 % of net product sales 10.0 % 9.5 % 7.5 % BUNAVAIL — 3,737 2,289 % of net product sales — % 2.4 % 2.1 % Net product sales $ 164,598 $ 154,574 $ 107,888 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income taxes: The provision for income taxes consisted of the following components for the years ended December 31: 2021 2020 Current: Federal $ — $ (326) State 1,289 578 Total current 1,289 252 Deferred: Federal (54,607) — State (1,920) — Total deferred (56,527) — Total provision for income taxes $ (55,238) $ 252 Reconciliation of the Federal statutory income tax rate of 21% to the effective rate is as follows: 2021 2020 2019 Federal statutory income tax rate 21.00 % 21.00 % 21.00 % State taxes, net of federal benefit (3.05) 1.75 (0.18) Stock compensation 3.22 4.47 (5.39) Permanent differences-other 0.02 3.77 (7.67) CARES Act 163(j) Modifications — 2.95 — Other (0.97) 3.94 1.71 Increase in valuation allowance (206.70) (36.91) (9.44) (186.48) % 0.97 % 0.03 % The tax effects of temporary differences and net operating losses that give rise to significant components of deferred tax assets and liabilities consist of the following: December 31, Deferred tax assets 2021 2020 Net operating loss carry-forward $50,535 $58,520 R&D credit 10,930 10,930 Accrued liabilities and other 1,533 1,004 Stock options 954 850 Less: valuation allowance (3,271) (66,495) Net deferred tax assets 60,681 4,809 Deferred tax liabilities Basis difference in intangibles (3,904) (4,696) Basis difference in equipment (250) (113) Total net deferred tax asset $ 56,527 $ — The Company is required to reduce any deferred tax asset by a valuation allowance if, based on an assessment of positive and negative evidence, including estimates of future taxable income necessary to realize future deductible amounts, it is more likely than not (a likelihood of more than 50 percent) that some portion or all of the deferred tax assets will not be realized. As a result, the Company recorded a valuation allowance with respect to all of the Company’s deferred tax assets for the year ended 2020 in the amount of $66.5 million and recorded a valuation allowance related to the federal R&D credit and state NOL’s in the amount of $3.3 million for the year ended December 31, 2021. The net decrease in the valuation allowance during 2021 was approximately $63 million. The Company has a federal net operating loss carry forward (“NOLs”) of approximately $218 million as of December 31, 2021. Under Section 382 and 383 of the Internal Revenue Code, if an ownership change occurs with respect to a “loss corporation”, as defined, there are annual limitations on the amount of the NOLs and other deductions, which are available to the Company. The Company has determined that the portion of the NOLs incurred prior to May 16, 2006 is subject to this limitation. As such, the use of these NOLs to offset taxable income is limited to approximately $1.5 million per year. The Company has state NOLs of approximately $222 million as of December 31, 2021. These state NOLs expire in various years through 2038 and certain state NOLs generated in 2018 have an indefinite carryforward period. The federal NOLs incurred through December 31, 2017 expire between 2024 and 2037. The federal NOL generated in 2018 has an indefinite carryforward life due to tax reform. Management has evaluated all other tax positions that could have a significant effect on the financial statements and determined that the Company has no uncertain income tax positions at December 31, 2021. One or more of the Company’s legal entities file income tax returns in the U.S. federal jurisdiction and various U.S. state jurisdictions. The Company’s income tax returns are subject to audit by the tax authorities in those jurisdictions. Significant disputes may arise with authorities involving issues of the timing and amount of deductions, the use of tax credits and allocations of income and expenses among various tax jurisdictions because of differing interpretations of tax laws, regulations and the interpretation of the relevant facts. The Company is no longer subject to U.S. federal or state tax examinations for years ended on or before December 31, 2017. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2021 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | Stockholders’ equity: Common Stock In connection with the Company’s Annual Meetings of Stockholders during 2019 and 2020, the Company’s stockholders approved, among other matters, amendments to the Company’s Certificate of Incorporation to increase the number of authorized shares of Common Stock in 2019 from 125,000,000 to 175,000,000, and in 2020 from 175,000,000 to 235,000,000. On November 4, 2020, the Board of Directors authorized the repurchase of up to $25 million of the Company's shares of Common Stock. The timing and amount of any shares purchased on the open market will be determined based on the Company's evaluation of market conditions, share price and other factors. The Company utilized existing cash on hand to fund the share repurchase program. During the year ended December 31, 2021, a cumulative total of 3,202,690 shares, priced at $3.69 for a value of $11.8 million were repurchased and recorded as Treasury Stock in the consolidated balance sheet. Preferred Stock and Series A Preferred The Company had authorized 5,000,000 “blank check” shares of $.001 par value convertible preferred stock. In the event of the Company’s liquidation, dissolution or winding up, holders of the Series A Preferred will receive a payment equal to $0.001 per share of Series A Preferred before any proceeds are distributed to the holders of common stock. After the payment of this preferential amount, and subject to the rights of holders of any class or series of capital stock hereafter created specifically ranking by its terms senior to the Series A Preferred, the holders of Series A Preferred will participate ratably in the distribution of any remaining assets with the common stock and any other class or series of our capital stock hereafter created that participates with the common stock in such distributions. During the year ended December 31, 2020, 2,093,155 shares of Series A were converted on a one-for-one basis into shares of Common Stock, which no shares of Series A Preferred remained outstanding as of that date. At December 31, 2021, 2,285,700 shares of “blank check” preferred stock remain authorized but undesignated. There were no conversions of Series A Preferred during the year ended December 31, 2019. Series B Preferred stock financing In May of 2018, the Company closed on the sale of an aggregate of 5,000 shares of the Company’s authorized preferred stock that the Board of Directors of the Company has designated as Series B Non-Voting Convertible Preferred Stock, par value $0.001 per share (the “Series B Preferred Stock”) at a purchase price of $10,000 per share. Each share of Series B Preferred Stock is convertible into a number of shares of the Company’s common stock at a conversion price of $1.80 per share (subject to adjustment for stock splits and stock dividends as provided in the Certificate of Designation). At the time of closing the then outstanding shares of Series B Preferred Stock were convertible into an aggregate 27,777,778 shares of Common Stock. The Series B Preferred Stock does not contain any price-based anti-dilution protection. The Series B Preferred Stock is convertible at any time at the option of the holder, subject to certain limitations related to beneficial ownership. The Company has the right to deliver a notice to the holders of the Series B Preferred Stock to require conversion of the Series B Preferred Stock into Common Stock. Following an initial forced conversion of the Series B Preferred Stock, every ninety (90) days thereafter, the Company has the right to require the forced conversion of the still outstanding shares of Series B Preferred Stock, subject to certain limitations related to beneficial ownership. There were no conversions of Series B Preferred Stock during the year ended December 31, 2021. As of December 31, 2021, 443 shares of Series B Preferred Stock are outstanding. Public Offering On April 15, 2019 the Company completed an underwritten public offering by the Company and a selling stockholder of 12,000,000 shares of common stock at a public offering price of $5.00 per share. The gross proceeds from the Company’s portion of the offering (10,000,000 shares), before deducting the underwriter discounts and commission and other offering expenses, was $50.0 million. The net proceeds were $47.6 million. The gross proceeds to the selling stockholder were approximately $19.0 million, which includes shares sold pursuant to the underwriters’ exercise of their option to purchase an additional 1,800,000 shares of common stock at the public offering price. Stock options During the 2019 Annual Meeting of Stockholders, shareholders approved an amendment to the Company’s 2011 Equity Incentive Plan (the "2011 EIP"), to increase the number of shares of common stock authorized for issuance under the plan by 7,100,000 shares from 11,050,000 to 18,150,000. Additionally, during the 2019 Annual Meeting of Stockholders, shareholders approved the Company’s 2019 Stock Option and Incentive Plan (the “2019 Plan”), which reserves 14,000,000 shares of stock for issuance under the 2019 Plan. An additional 2,677,041 shares of Common Stock underlying options previously granted under the 2011 EIP, remain outstanding and exercisable as of December 31, 2021. The 2011 EIP expired in July 2019 and no new securities may be issued thereunder. Options may be awarded during the ten-year term of the 2019 Plan to Company employees, directors, consultants and other affiliates. During the years ended December 31, 2021, 2020 and 2019, Company employees, directors and affiliates exercised approximately 160,000, 1,400,000 and 800,000 stock options, respectively, with net proceeds to the Company of approximately $0.5 million, $3.4 million and $2.3 million, respectively. The intrinsic value of options exercised during the years ended December 31, 2021, 2020 and 2019 was approximately $0.1 million, $3.5 million and $1.9 million, respectively. Stock option activity for the year ended December 31, 2021 is as follows: Number of Weighted Average Aggregate Outstanding at January 1, 2021 7,060,966 $ 4.55 $ 2,831 Granted in 2021: Officers and Directors 1,678,425 $ 3.88 Employees 2,145,494 4.12 Exercised (160,023) 2.90 Forfeitures (1,112,101) 4.54 Outstanding at December 31, 2021 9,612,761 $ 4.37 $ 520 Options outstanding at December 31, 2021 are as follows: Range of Exercise Prices Number Weighted Average Weighted Average Aggregate $1.00 – 5.00 7,367,252 8.15 $ 3.82 $5.01 – 10.00 2,194,085 7.56 $ 5.95 $10.01 – 15.00 29,924 3.14 $ 13.09 $15.01 – 20.00 21,500 2.75 $ 16.47 9,612,761 $ 520 Options exercisable at December 31, 2021 are as follows: Range of Exercise Prices Number Weighted Average Weighted Average Aggregate $1.00 – 5.00 3,201,210 7.02 $ 3.61 $5.01 – 10.00 1,252,843 7.1 $ 6.06 $10.01 – 15.00 29,924 3.14 $ 13.09 $15.01 – 20.00 21,500 2.75 $ 16.47 4,505,477 $ 479 The weighted average grant date fair value of options granted during the years ended December 31, 2021, 2020 and 2019 was $4.01, $5.13 and $4.29, respectively. There were no options granted during the years ended December 31, 2021, 2020 or 2019 whose exercise price was lower than the estimated market price of the stock at the grant date. Nonvested stock options as of December 31, 2021, and changes during the year then ended, are as follows: Nonvested Shares Shares Weighted Average Intrinsic Nonvested at January 1, 2021 4,045,200 Granted 3,823,919 Vested (1,811,558) Forfeited (950,277) Nonvested at December 31, 2021 5,107,284 $ 4.32 $ 41 As of December 31, 2021, there was approximately $8.3 million of unrecognized compensation cost related to unvested share-based compensation awards granted. These costs will be expensed over the next three years. Stock-based compensation During the year ended December 31, 2021, a total of 3,823,919 options to purchase Common Stock, with an aggregate fair market value of approximately $15.3 million, were granted to Company employees and directors. The options granted have a term of 10 years from the grant date and vest ratably between a one Restricted stock units During the year ended December 31, 2021, 337,628 RSUs were issued under the 2019 Plan to members of the Company’s executive officers, board of directors and certain employees, with a fair market value of approximately $1.3 million, which vest in equal installments from one Restricted stock activity during the year ended December 31, 2021 was as follows: Number of Weighted Outstanding at January 1, 2021 940,759 $ 3.71 Granted: Officers and Directors 301,821 $ 3.88 Employees 35,807 $ 3.84 Vested (542,825) $ 3.79 Forfeitures (101,215) $ 4.25 Outstanding at December 31, 2021 634,347 $ 4.09 Warrants: The Company has granted warrants to purchase shares of Common Stock. Warrants may be granted to affiliates in connection with certain agreements. As of December 31, 2021, a cumulative total of 2,051,033 warrants to affiliates, with exercise prices ranging from $2.38 to $3.42, remain exercisable and outstanding. The warrants were valued using the Black-Scholes Model, with a cumulative fair value of approximately $4.5 million. There were no warrants granted or exercised during the years ended December 2021, 2020 or 2019. |
Earnings per Common Share
Earnings per Common Share | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Earnings per Common Share | Earnings per common share: The following is a reconciliation of the numerators and denominators of the basic and diluted earnings per common share computations for the years ended December 31, 2021, 2020 and 2019. December 31, 2021 2020 2019 Basic: Net income (loss) attributable to common stockholders, basic $ 84,860 $ 25,711 $ (15,305) Weighted average common shares outstanding 99,320,285 99,830,520 83,213,704 Basic income (loss) per common share $ 0.85 $ 0.26 $ (0.18) Diluted: Effect of dilutive securities: Net income (loss) attributable to common stockholders, diluted $ 84,860 $ 25,711 $ (15,305) Weighted average common shares outstanding 99,320,285 99,830,520 83,213,704 Effect of dilutive options and warrants 3,972,703 5,232,002 — Diluted weighted average common shares outstanding 103,292,988 105,062,522 83,213,704 Diluted income (loss) per common share $ 0.82 $ 0.24 $ (0.18) Basic earnings per common share is calculated using the weighted average shares of Common Stock outstanding during the period. Common equivalent shares from stock options, RSUs, warrants and convertible preferred stock using the treasury stock method, are also included in the diluted per share calculations unless the effect of inclusion would be antidilutive. During the years ended December 31, 2021 and 2020, outstanding stock options, RSUs, warrants and convertible preferred stock of 3,972,703 and 5,232,002, respectively, were included in the computation of diluted earnings per common share. During the year ended 2019, outstanding stock options, RSUs, warrants and convertible preferred stock of 11,116,195, were not included in the computation of diluted earnings per common share, because to do so would have had an antidilutive effect because the outstanding exercise prices were greater than the average market price of the common shares during the relevant periods. Included in the years ended December 31, 2021, 2020 and 2019 are the Series B shares as converted to common stock. The following is the total outstanding options, RSUs and warrants for the years ended December 31, 2021, 2020 and 2019, respectively. 2021 2020 2019 Options, RSUs, warrants and convertible preferred stock to purchase Common Stock 14,759,254 12,598,857 11,375,323 |
Retirement Plan
Retirement Plan | 12 Months Ended |
Dec. 31, 2021 | |
Retirement Benefits [Abstract] | |
Retirement Plan | Retirement plan:The Company sponsors a defined contribution retirement plan under Section 401(k) of the Internal Revenue Code. The plan covers all employees who meet certain eligibility and participation requirements. Participants may contribute up to 90% of their eligible earnings, as limited by law. The Company makes a matching contribution equal to 100% on the first 5% of participant contributions to the plan. The Company made contributions of approximately $1.1 million , $1.1 million and $1.0 million during the years ended December 2021, 2020 and 2019. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and contingencies: Indemnifications The Company’s directors and officers are indemnified against costs and expenses related to stockholder and other claims (i.e., only actions taken in their capacity as officers and directors) that are not covered by the Company’s directors’ and officers’ insurance policy. This indemnification is ongoing and does not include a limit on the maximum potential future payments, nor are there any recourse provisions or collateral that may offset the cost. Post marketing requirements On October 5, 2017, the Company entered a subsequent party acknowledgement relating to its participation in the Opioid PMR Consortium (the “OPC”). The participants are member companies, collectively undertaking various observational and clinical studies to satisfy certain post-marketing requirements by the FDA as holders of a NDA for extended-release and long-acting opioid analgesics. As a requirement of joining the OPC, the Company was required to pay its share of the previous expenses incurred and funded by the existing member companies. The Company’s pro-rata share of such expenses totaled approximately $4.3 million, which was paid during the fourth quarter of 2019. Ongoing expenses are shared equally by the member companies and were paid monthly during 2021 and 2020. Future ongoing expenses are anticipated to be paid monthly in 2022 through 2023. Certain rights of CDC IV The Company and CDC IV are parties to the CDLA pursuant to which CDC IV has previously provided funds to the Company for the development of the Company’s ONSOLIS product. CDC IV is entitled to receive a mid-single digit royalty based on net sales of ONSOLIS, including minimum royalties of $375,000 per quarter beginning in the second full year following commercial launch. The royalty term expires upon the latter of expiration of the patent or generic entry into a particular country. In September 2007, in connection with CDC IV’s consent to the North American Mylan transaction, the Company, among other transactions with CDC IV, granted CDC IV a 1% royalty on net sales of the next BEMA product, which was BUNAVAIL. CDC IV’s right to the royalty shall immediately terminate at any time if annual net sales of BUNAVAIL equal less than $7.5 million in any calendar year following the third anniversary of initial launch of the product and CDC IV receives $0.02 million in three (3) consecutive quarters as payment for CDC IV’s one percent (1)% royalty during such calendar year. In April 2016, CDC IV exercised its right pursuant to the Royalty Purchase and Amendment Agreement to exchange its royalty rights to the next BEMA product which was BUNAVAIL, in favor of royalty rights to the Substitute BEMA product which is BELBUCA (the CDC IV Option). The Company records such royalties as costs of sales occur. 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 did not appeal the Delaware Court’s holding that other claims of the ‘832 Patent are invalid. On February 10, 2021, the parties in our EDNC declaratory judgment action filed a covenant by Indivior and Aquestive not to sue us for infringement of the ‘832 Patent. In view of that covenant and the prior invalidation of the ‘080 patent, we filed a notice of voluntary dismissal of the Company’s EDNC declaratory judgement action. 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. On October 5, 2020, the U.S. Supreme Court denied the Company’s petition for certiorari. On May 18, 2021, the RB Plaintiffs filed an amended complaint dropping the Company’s commercial partner from the action it began on September 22, 2014. On June 1, 2021, the Company answered the amended complaint asserting counter-claims of non-infringement, invalidity, and unenforceability. The Company strongly refutes as without merit the Plaintiffs’ assertion of patent infringement and will vigorously defend the lawsuit. 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. On January 13, 2020, in lieu of answering the complaint, we filed a motion to dismiss the complaint. After the two motions were denied, on April 16, 2020, we answered the complaint. Aquestive moved to dismiss our counter-claim of unenforceability, but the court denied that motion. 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 scheduled a bench trial to commence on November 9, 2020 to adjudicate issues concerning the validity of the Orange Book patents listed for BELBUCA. On October 6, 2020, the Court rescheduled the bench trial with Alvogen to commence on March 1, 2021. A three day bench trial against Alvogen was conducted commencing on March 1, 2021. At the conclusion of trial, the Court ordered the parties to submit post-trial briefs. Post-trial briefing was completed on May 26, 2021. The Company subsequently moved the Court to strike (i.e., remove from the Court’s consideration) three patent invalidity defenses raised for the first time in Alvogen’s post-trial briefs and two documents improperly cited in Alvogen’s post-trial briefs. On June 28, 2021, the Court granted the Company’s motion to strike in its entirety. In addition, on June 28, 2021, the Court enjoined Alvogen from launching its generic product until the Court issues its final decision on the merits. On September 21, 2021, the Company filed under seal a Motion for Order to Show Cause why Defendants Should not be Held in Contempt for Violating the Court Order of June 28, 2021 (the “Motion”). On June 28, 2021, citing the statute authorizing the Court to extend the 30-month stay under the Hatch-Waxman Act, the Court ordered Alvogen (as defined below) not to “launch” its generic product until it could reach a final decision on the merits in the case. In the Motion, the Company contends that Alvogen violated the order of the United States District Court for the District of Delaware commencing in or about August 2021 by, among other things, offering the generic product for sale through five compendia / price reporting services, including First Databank, Medi-Span (Wolters Kluwer), Red Book, Gold Standard and ScriptPro. As alleged in the Motion, after Alvogen’s product launch, certain payers began declining insurance coverage for the Company’s brand BELBUCA and directing use of Alvogen’s generic substitute and/or made it more difficult for patients to obtain insurance coverage for BELBUCA, and thereby damaged the Company. In addition to filing the Motion, the Company demanded that Alvogen withdraw its compendia listings. Alvogen claims to have withdrawn its compendia product listings on or about September 9, 2021. On December 20, 2021, the Court issued an opinion upholding the validity of claims in BDSI’s ‘866 patent, which expires in 2027, and claims in the ’539 patent, which expires in 2032. Alvogen conceded infringement of those claims prior to the trial. The Court entered final judgment on January 21, 2022. Alvogen has filed a notice of appeal to the Federal Circuit seeking to reverse the Court’s final judgment entered on January 21, 2022. Separately, Alvogen filed a motion to stay certain provisions of the final judgment in the Court. BDSI has filed a cross-appeal to the Federal Circuit seeking to reverse the Court’s opinion that claims 3 and 10 of the ’866 patent and claims 8, 9 and 20 of the ’843 patent are invalid and thus Alvogen is not liable for infringement of those claims, as well as any other ruling decided adversely to BDSI. BDSI also filed its opposition to Alvogen’s request for a stay. The Court retained jurisdiction to decide the Company’s pending motion for contempt. The final judgment entered in this case upholding the validity of claims of the ’866 and ’539 Orange Book listed patents extends the effective date of any final approval by the FDA of Alvogen’s ANDA until December 21, 2032, which is the expiration date of the ’539 patent, and enjoins Alvogen and those acting in concert with Alvogen from commercially manufacturing, using, selling, or offering for sale Alvogen’s ANDA products from until December 21, 2032. 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 Bench Trial to adjudicate issues concerning the validity of the Orange Book listed patents covering BELBUCA was held on March 1, 2021. Chemo did not participate in the bench trial. Instead, on February 26, 2021, Chemo agreed to be bound by the decision of the Court with respect to the validity of the BEMA patents from the March 1, 2021 trial with Alvogen. On December 20, 2021, the Court issued an opinion upholding the validity of claims in BDSI’s ‘866 patent, which expires in 2027, and claims in the ’539 patent, which expires in 2032, to which Chemo is bound. The bench trial to adjudicate issues concerning the Chemo Defendants’ infringement of the Orange Book patents to commence on April 25, 2022. 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 or non-infringement. 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 alleged that the Amendments did not receive the requisite vote of stockholders at the 2018 Annual Meeting and asserted claims for violation of the Delaware General Corporation Law, breach of fiduciary duties, and declaratory judgment. The Complaint sought, 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 sought costs and disbursements, including attorneys’ fees. On July 1, 2020, the Company filed their response to the Complaint and denied the claims asserted therein. 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. On October 8, 2020, the Court entered an agreed-to order dismissing the plaintiffs’ claims for violation of the Delaware General Corporation Law. On October 13, 2020, plaintiffs filed an amended complaint, asserting individual, class and derivative claims for breach of fiduciary duties against our directors. On October 26, 2020, the defendants filed a motion to dismiss the amended complaint. On February 19, 2021, plaintiffs filed their opposition to the motion to dismiss. On March 8, 2021, the defendants filed a reply in further support of the motion to dismiss. On June 23, 2021, the Court issued an order granting defendants’ partial motion to dismiss in part and ordered the parties to submit supplemental briefing on a remaining claim. On October 29, 2021, following the submission of supplemental briefing by both parties, the Court entered an order denying the remainder of defendants’ partial motion to dismiss. On November 18, 2021, the defendants filed their answer to the amended complaint. On February 7, 2022, the parties executed and filed with the Court a Stipulation and Agreement of Compromise, Settlement, and Release. The settlement is subject to the Court’s approval and approval hearing is scheduled for June 2, 2022. Merger Litigation On February 25, 2022, in connection with the proposed acquisition of the Company by affiliates of Collegium Pharmaceuticals, Inc. (the “Transaction’), a purported individual stockholder of the Company filed a complaint in the United States District Court for the Southern District of New York, captioned Stein v. BioDelivery Sciences International, Inc., et al. , No. 1:22-cv-01600, naming as defendants the Company and each member of the Company Board as of the date of the Merger Agreement (“Stein”). On February 28, 2022, two additional cases were filed by purported individual shareholders of BDSI in the same court, captioned Sanford v. BioDelivery Sciences International, Inc., et al ., 1:22-cv-01676 (Sanford), and Higley v. BioDelivery Sciences International, Inc., et al. , No. 1:22-cv-01658 (Higley). On March 2, 2022 and March 5, 2022, two additional cases were filed by purported individual shareholders of the Company in the United States District Court for the Eastern District of New York, captioned Justice II v. BioDelivery Sciences International, Inc., et al. , 1:22-cv-01145 (“Justice”) and Zomber v. BioDelivery Sciences International, Inc., et al., 1:22-cv-01220 ("Zomber"). The Stein , Sanford , Higley , Justice , Zomber and any similar subsequently filed cases involving the Company, the Company Board or any committee thereof and/or any of the Company’s directors or officers relating directly or indirectly to the Merger Agreement, the Transaction or any related transaction, are referred to as the “Transaction Litigations.” The Transaction Litigations filed to date generally allege that the Solicitation/Recommendation Statement on Schedule 14D-9 (the “Schedule 14D-9”) filed by BDSI with the SEC on February 18, 2022 in connection with the Transaction is materially incomplete and misleading by allegedly failing to disclose purportedly material information relating to the sale process leading to the Transaction, the Company’s financial projections, and the analyses performed by Moelis & Company LLC in connection with the Transaction. The Transaction Litigations assert violations of Section 14(e) of the Securities Exchange Act of 1934 (the “Exchange Act”) and violations of Section 20(a) of the Exchange Act against the Company Board. Additionally, the Stein, Higley, Justice, and Zomber complaints assert violations of Section 14(d) of the Exchange Act and Rule 14d-9 promulgated thereunder. The Transaction Litigations seek, among other things: an injunction enjoining consummation of the Transaction, rescission of the Merger Agreement, a declaration that the Company and the Company Board violated Sections 14(e) and 20(a) of the Exchange Act and Rule 14a-9 promulgated thereunder, damages, costs of the action, including plaintiff’s attorneys’ fees and experts’ fees and expenses, and any other relief the court may deem just and proper. In addition, on February 24, 2022 and February 28, 2022, and March 7, 2022 the Company received demand letters from three purported BDSI stockholders seeking to inspect certain books and records of the Company related to the Merger (the “Inspection Letters”) On March 4, 2022, the Company received a demand letter from a purported BDSI stockholder alleging that the 14D-9 omits purportedly material information relating to the Transaction (the "Demand Letter").. BDSI cannot predict the outcome of the Transaction Litigations, Inspection Letters or Demand Letter, nor can BDSI predict the amount of time and expense that will be required to resolve each. BDSI believes that the Transaction Litigations, Inspection Letters and Demand Letter are without merit and i |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events: Merger Agreement On February 14, 2022, the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Collegium Pharmaceutical, Inc., a Virginia corporation (“Collegium”), and Bristol Acquisition Company Inc., a Delaware corporation and wholly owned subsidiary of Collegium (“Purchaser”). Pursuant to the Merger Agreement, upon the terms and subject to the conditions thereof, as promptly as practicable (but in no event more than 10 business days after the date of the Merger Agreement), Purchaser will commence a cash tender offer (the “Offer”), to acquire all of the outstanding shares (the “Shares”) of BDSI’s common stock, $0.001 par value per share (the “BDSI Common Stock”), at an offer price of $5.60 per Share in cash, subject to applicable withholding taxes and without interest (the “Offer Price”). The Offer will initially remain open for 20 business days from the date of commencement of the Offer, subject to extension under certain circumstances. The obligation of Purchaser to purchase Shares tendered in the Offer is subject to customary closing conditions set forth in the Merger Agreement, including, but not limited to, that (i) at least one Share more than 50% of the total number of Shares of BDSI Common Stock issued and outstanding have been validly tendered into and not validly withdrawn from the Offer and (ii) the waiting period (or any extension thereof) applicable to the Offer under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, and the rules and regulations promulgated thereunder, have expired or been terminated. Neither the completion of the Offer nor the closing of the Merger are subject to a financing condition. Following the completion of the Offer and subject to the satisfaction or waiver of certain conditions set forth in the Merger Agreement, Purchaser will merge with and into BDSI, with BDSI surviving as a wholly owned subsidiary of Collegium (the “Merger”). The Merger shall be governed by and effected under Section 251(h) of the Delaware General Corporation Law (the “DGCL”), with no stockholder vote required to consummate the Merger. At the effective time of the Merger (the “Effective Time”), the Shares then outstanding (other than Shares held by (i) BDSI or its subsidiaries (including Shares held in BDSI’s treasury), (ii) Collegium, Purchaser, any other direct or indirect wholly owned subsidiary of Collegium, or (iii) stockholders of BDSI who have properly exercised and perfected their statutory rights of appraisal under the DGCL) will each be converted into the right to receive the Offer Price. The board of directors of BDSI (the “BDSI Board”) has unanimously (i) approved, adopted and declared advisable the Merger Agreement and the transactions contemplated thereby, including the Offer and the Merger (the “Transactions”), (ii) determined that the transactions contemplated thereby, including the Transactions, are in the best interests of BDSI and its stockholders, (iii) resolved that the Merger shall be governed by and effected under Section 251(h) of the DGCL and (iv) resolved to recommend that the stockholders of BDSI accept the Offer and tender their Shares to Purchaser pursuant to the Offer. The Merger Agreement provides that each stock option to purchase shares of BDSI Common Stock (a “BDSI Option”) that is outstanding as of immediately prior to the Effective Time shall automatically accelerate and become fully vested and exercisable effective immediately prior to, and contingent upon, the Effective Time. As of the Effective Time, each BDSI Option with a per share exercise price less than the Offer Price that is then outstanding and unexercised shall be cancelled and converted into the right to receive cash in an amount equal to the product of (x) the total number of Shares subject to such BDSI Option multiplied by (y) the excess, if any, of the Offer Price over the exercise price payable per Share under such BDSI Option, net of applicable withholding taxes. Each BDSI Option with an exercise price equal to, or greater than, the Offer Price that is then outstanding and unexercised shall be cancelled without any consideration paid therefor whether before or after the Effective Time. The Merger Agreement also provides that each restricted stock unit award issued by BDSI (a “BDSI RSU”) that is outstanding as of immediately prior to the Effective Time shall automatically accelerate and become fully vested immediately prior to, and contingent upon, the Effective Time. As of the Effective Time, each BDSI RSU that is then outstanding shall be cancelled and converted into the right to receive cash in an amount equal to the product of (x) the total number of Shares issuable in settlement of such BDSI RSU multiplied by (y) the Offer Price. The Merger Agreement further provides that, as of the Effective Time, each outstanding warrant to purchase shares of BDSI Common Stock (a “BDSI Warrant”) that is outstanding as of immediately prior to the Effective Time with an exercise price less than the Offer Price shall be cancelled and converted into the right to receive cash in an amount equal |
Schedule II - Valuation and Qua
Schedule II - Valuation and Qualifying Accounts and Reserves | 12 Months Ended |
Dec. 31, 2021 | |
SEC Schedule, 12-09, Valuation and Qualifying Accounts [Abstract] | |
Valuation and Qualifying Accounts and Reserves | SCHEDULE II – VALUATION AND QUALIFYING ACCOUNTS AND RESERVES Balance at Charged Charged to Deductions Balance at (In thousands) Description Valuation allowance for deferred tax assets Year ended December 31, 2021: $ 66,495 $ (56,527) $ — $ (6,697) $ 3,271 Year ended December 31, 2020: $ 76,079 $ (9,584) $ — $ — $ 66,495 Year ended December 31, 2019: $ 75,458 $ 621 $ — $ — $ 76,079 Allowance for rebates Year ended December 31, 2021: $ 34,247 $ 135,315 $ (55) $ (130,826) $ 38,681 Year ended December 31, 2020: $ 29,429 $ 113,854 $ (109,036) $ 34,247 Year ended December 31, 2019: $ 12,261 $ 80,404 $ 2,565 $ (65,801) $ 29,429 Allowance for distribution fees Year ended December 31, 2021: $ 5,502 $ 30,397 $ 55 $ (30,417) $ 5,537 Year ended December 31, 2020: $ 6,005 $ 27,581 $ (28,084) $ 5,502 Year ended December 31, 2019: $ 4,018 $ 29,552 $ (901) $ (26,664) $ 6,005 Allowance for inventory obsolescence Year ended December 31, 2021: $ 2,254 $ 4,340 $ — $ (2,414) $ 4,180 Year ended December 31, 2020: $ 384 $ 1,870 $ — $ — $ 2,254 Year ended December 31, 2019: $ 187 $ 289 $ — $ (92) $ 384 |
Nature of Business and Summar_2
Nature of Business and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Organization | Organization BioDelivery Sciences International, Inc. (the “Company”) was incorporated in the State of Indiana on January 6, 1997 and reincorporated as a Delaware corporation in 2002. The Company’s subsidiaries are Arius Pharmaceuticals, Inc., a Delaware corporation (“Arius One”) and Arius Two, Inc., a Delaware corporation (“Arius Two”), each of which are wholly-owned. The Company is a rapidly growing specialty pharmaceutical company working to deliver innovative therapies for individuals living with serious and debilitating chronic conditions. The Company has built a portfolio of products that includes utilizing its novel and proprietary BioErodible MucoAdhesive, or BEMA, drug-delivery technology to develop and commercialize new applications of proven therapies aimed at addressing important unmet medical needs. The Company commercializes 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. As used herein, the Company’s common stock, par value $0.001 per share, is referred to as the “Common Stock” and the Company’s preferred stock, par value $0.001 per share, is referred to as the “Preferred Stock”. |
Principles of consolidation | Principles of consolidation The consolidated financial statements include the accounts of the Company, Arius One and Arius Two. All significant inter-company balances and transactions have been eliminated. |
Use of estimates in financial statements | Use of estimates in financial statements The preparation of the accompanying consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the period. Actual results could differ from those estimates. The Company reviews all significant estimates affecting the consolidated financial statements on a recurring basis and records the effect of any necessary adjustments prior to their issuance. Significant estimates made by the Company include: revenue recognition associated with sales allowances such as government program rebates, customer voucher redemptions, commercial contracts, rebates and chargebacks; sales returns reserves; sales bonuses; stock-based compensation; and deferred income taxes. |
Concentrations of credit risk | Concentrations of credit risk 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 places cash on deposit with financial institutions in the United States that management believes are of high credit quality. The Federal Deposit Insurance Corporation ("FDIC") covers $0.25 million for substantially all depository accounts. The Company is exposed to credit risk in the event of default by the financial institution to the extent that cash and cash equivalent balances recorded in the balance sheets are in excess of the amounts that are insured by the FDIC. The Company has not experienced any losses on its deposits since inception, and management believes that minimal credit risk exists with respect to these financial institutions. |
Liquidity | The Company believes that it has sufficient cash, along with expected proceeds from sales of BELBUCA and Symproic, to manage the business as currently planned.Additional capital may be required to support the continued commercialization of the Company's BELBUCA and Symproic products, the commercial launch of ELYXYB, or other products which may be acquired or licensed by the Company, and for general working capital requirements. Based on agreements with the Company's partners, the ability to scale up or reduce personnel and associated costs are factors considered throughout the product life cycle. Available resources may be consumed more rapidly than currently anticipated, potentially resulting in the need for additional funding. |
Accounts receivable | Accounts receivable The Company's accounts receivable balance consists of amounts due from product sales. Receivables are recorded net of allowances for trade discounts, distribution fees, prompt pay discounts, and doubtful accounts. The Company performs ongoing credit evaluations and does not require collateral. As appropriate, the Company establishes provisions for potential credit losses. The Company recorded $0.01 million in allowances for doubtful accounts as of December 31, 2021 and in 2020, respectively. The Company writes off accounts receivable when management determines they are uncollectible and credits payments subsequently received on such receivables to bad debt expense in the period received. |
Inventory | Inventory Inventories are stated at the lower of cost or net realizable value with costs determined for each batch under the first-in, first-out method and specifically allocated to remaining inventory. Inventory consists of raw materials, work in process and finished goods. Raw materials include amounts of active pharmaceutical ingredient for a product to be manufactured, work in process includes the bulk inventory of laminate (the Company’s drug delivery film) prior to being packaged for sale, and finished goods include pharmaceutical products ready for commercial sale. |
Property and equipment | Property and equipment The Company records property and equipment at cost less accumulated depreciation, which is computed on a straight-line basis over its estimated useful lives, generally 3 to 10 years. The Company evaluates the carrying value of equipment when events or changes in circumstances indicate the related carrying amount may not be recoverable. In connection with the discontinuation of the marketing of BUNAVAIL, the company recorded an additional $0.3 million and $1.5 million of depreciation related to certain equipment used in the production of BUNAVAIL, during 2020 and 2019, respectively. The Company has certain manufacturing equipment that isn’t currently in production, which has been deemed idle. The Company impaired certain obsolete office equipment totaling $0.3 million during the year ended December 31, 2020. There was no impairment of equipment recorded during the year ended 2021. |
Intangibles and goodwill | Intangibles and goodwill The Company reviews intangible assets with finite lives (“other intangible assets”) for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company uses an estimate of the undiscounted cash flows over the remaining life of its other intangible assets, or related group of assets where applicable, in measuring whether the assets to be held and used will be realizable. In the event of impairment, the Company would discount the future cash flows using its then estimated incremental borrowing rate to estimate the amount of the impairment. There were no impairment charges recognized on finite lived intangibles in 2021, 2020 or 2019. Intangible assets with finite useful lives are amortized over the estimated useful lives as follows: Estimated Licenses 15 years BELBUCA license and distribution rights 10 years Symproic license and distribution rights 12 years ELYXYB product rights 15 years |
Revenue recognition | Revenue recognition The Company recognizes revenue in accordance with ASC, Topic 606, Revenue from Contracts with Customers ("ASC606"), which was adopted on January 1, 2018, using the modified retrospective transition method. Product sales Product sales amounts relate to sales of BELBUCA, Symproic and formerly BUNAVAIL. 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. The Company discontinued marketing of BUNAVAIL in June 2020. 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 including any associated financing component. 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 has determined that the delivery of its product to its customers constitutes a single performance obligation as there are no other promises to deliver goods or services. Shipping and handling activities are considered to be fulfillment activities and are not considered to be a separate performance obligation. The Company has assessed the existence of a significant financing component in the agreements with its customers. The trade payment terms with its customers do not exceed one year and therefore the Company has elected to apply the practical expedient and no amount of consideration has been allocated as a financing component. 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: • 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 third-party prescription data providers; • 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. In connection with the 2020 discontinuation of marketing of BUNAVAIL, the 2019 results included a reserve of $2.2 million for additional BUNAVAIL product returns. Subsequently, the majority of these reserves were released during 2020, as the Company did not experience an increase in the rate of returns following the discontinuation announcement, nor upon the actual discontinuation. 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 combination of historical experience, product pricing, estimated payor mix, product growth, and the mix of contract and agreement terms. 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. In addition, the pricing of covered products under Medicaid is subject to complex calculations and involves interpretation of government rules, regulations and policies as well as adjustments based on current trends in utilization. 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. Patient Assistance Voucher program- The Company, from time to time, offers certain promotional product-related incentives to eligible patients. The Company has voucher programs for BELBUCA and Symproic 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 the provision of 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. License and development agreements The Company periodically enters into license and development agreements to develop and commercialize its products. The arrangements typically are multi-deliverable arrangements that are funded through upfront payments, milestone payments and other forms of payment. The Company currently has license agreements that are described in note 7, of which these revenues are classified as contract revenue. |
Cost of sales | Cost of sales Cost of sales includes the direct costs attributable to the production of BELBUCA, Symproic and formerly BUNAVAIL. It includes raw materials, production costs at the Company’s three contract manufacturing sites, quality testing directly related to the products, inventory reserves, and depreciation on equipment that the Company had purchased to produce BELBUCA, Symproic and formerly BUNAVAIL. It also includes any batches not meeting specifications and raw material yield losses. Yield losses and batches not meeting specifications are expensed as incurred. Cost of sales is recognized when sold to the wholesaler from our distribution center. For BREAKYL and PAINKYL (the Company’s out-licensed breakthrough cancer pain therapies), cost of sales includes all costs related to creating the product at the Company’s contract manufacturing location in Germany. The Company’s contract manufacturer bills the Company for the final product, which includes materials, direct labor costs, and certain overhead costs as outlined in applicable supply agreements. Cost of sales also includes royalty expenses that the Company owes to third parties. |
Advertising | AdvertisingAdvertising costs, which include promotional expenses and the cost of placebo samples, are expensed as incurred. |
Shipping and handling costs | Shipping and handling costsShipping and handling costs, which include expenses from our wholesalers, are expensed as incurred. |
Stock-based compensation | Stock-based compensation The Company has a stock-based compensation plan under which various types of equity-based awards are granted, including stock options, performance-based options, restricted stock units (RSUs) and performance-based RSUs. The fair value of stock option and RSUs, which are subject only to service conditions with graded vesting, are recognized as compensation expense, generally on a straight-line basis over the service period, net of estimated forfeitures. The fair values of performance-based options and RSUs are recognized as compensation expense beginning from when the performance is determined to be probable to the end of the performance period. The Company uses the fair-value based method to determine compensation for all arrangements under which employees and others receive shares of stock or equity instruments (warrants and options). The grant date fair value of an RSU equals the closing price of our common stock on the trading day of the grant date. The fair value of each option and warrant is estimated on the date of grant using the Black-Scholes valuation model that uses assumptions for expected volatility, expected dividends, expected term, and |
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) |
Income Taxes | Income Taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Management considers the scheduled reversal of deferred tax liabilities, projected future taxable income, and tax planning strategies in making that assessment. We recognize the effect of income tax positions only if those positions are more likely than not of being sustained. Recognized income tax positions are measured at the largest amount that is greater than 50% likely of being realized. Changes in recognition or measurement are reflected in the period in which the change in judgment occurs. Our policy for recording interest and penalties associated with audits is that penalties and interest expense are recorded in provision for income taxes in our statements of operations. The Company had no uncertain tax positions as of December 31, 2021 or December 31, 2020. Interest and, if applicable, penalties are recognized related to uncertain tax positions in income tax expense. There are no accruals for interest and penalties as of December 31, 2021. |
Measurement of credit losses of financial instruments | Measurement of credit losses of financial instruments 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 December 31, 2021, the Company reported $56.9 million of trade receivables within accounts receivable. Based on an aging analysis at December 31, 2021, 95% of the Company's accounts receivable were outstanding less than 30 days. 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. |
New Accounting Pronouncements | New Accounting Pronouncements 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 was permitted. The Company adopted Topic 740 during 2021 and determined that the new guidance did not have a material impact on its consolidated financial statements. The Company has reviewed other new accounting pronouncements that were issued as of December 31, 2021 and does not believe that these pronouncements are applicable to the Company, or that they will have a material impact on its financial position or results of operations. |
Nature of Business and Summar_3
Nature of Business and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Schedules of Concentration of Risks | Concentration of customers The following customers accounted for 10% or more of total net revenue for the years ended December 31, 2021, 2020 and 2019: Year Ended December 31, Customers 2021 2020 2019 % % % A 34% 33% 34% B 35% 34% 33% C 28% 27% 27% Concentration of suppliers The following suppliers accounted for 10% or more of inventory purchases for the years ended December 31, 2021, 2020. and 2019. Year Ended December 31, Suppliers 2021 2020 2019 $ $ $ A 15,045 17,429 8,142 B 4,362 3,756 1,755 C * 2,603 11,218 * Represents less than 10% of inventory purchases. |
Summary of Inventories | Inventory is composed of the following at December 31: 2021 2020 Raw Materials & Supplies $ 3,674 $ 3,389 Work-in-process 9,926 9,949 Finished Goods 14,291 6,359 Inventory Reserve (4,180) (2,254) Total Inventories $ 23,711 $ 17,443 |
Summary of Useful Lives of Finite Lived Intangible Assets | Intangible assets with finite useful lives are amortized over the estimated useful lives as follows: Estimated Licenses 15 years BELBUCA license and distribution rights 10 years Symproic license and distribution rights 12 years ELYXYB product rights 15 years |
Summary of Black-Scholes Options-Pricing Model Assumptions | In applying the Black-Scholes options-pricing model, assumptions are as follows: 2021 2020 2019 Expected price volatility 53.70%-59.87% 59.00%-61.76% 61.66%-64.10% Risk-free interest rate 0.50%-1.38% 0.25%-1.68% 1.36%-2.66% Weighted average expected life in years 6 years 6 years 6 years Dividend yield — — — |
Summary of Cash and Cash Equivalents Measured At Fair Value on a Recurring Basis | The following table summarizes the cash and cash equivalents measured at fair value on a recurring basis as of December 31, 2021: Level 1 Level 2 Level 3 Balance at December 31, 2021 Cash and cash equivalents $ 114,309 — — $114,309 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Components of Lease Expense and Supplemental Cash Flow Information Related To Leases | The components of lease expense were as follows: Year Ended December 31, 2021 2020 2019 Lease cost Operating lease cost Operating lease $ 336 $ 328 $ 328 Variable lease costs 34 19 13 Total lease cost $ 370 $ 347 $ 341 Supplemental cash flow information related to leases were as follows: Year Ended December 31, 2021 2020 2019 Other information Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ 370 $ 361 $ 351 Year Ended December 31, 2021 2020 Lease term and discount rate Weighted-average remaining lease term operating leases 2.0 years 2.0 years Weighted-average discount rate operating leases 11.8 % 11.8 % |
Future Minimum Lease Payments | Future minimum lease payments under non-cancellable leases as of December 31, 2021 were as follows: Maturity of lease liabilities 2022 $381 2023 226 Total lease payments 607 Less: Interest (52) Present value of lease liabilities $555 |
Components of Lease Assets and Liabilities | Components of Lease Assets and Liabilities December 31, 2021 Assets Property and equipment, net operating lease-right of use asset $ 520 Liabilities Current liabilities operating lease-current liability $ 336 Other long-term liabilities operating lease-noncurrent liability 219 Total lease liabilities $ 555 |
Accounts Payable and Accrued _2
Accounts Payable and Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Payables and Accruals [Abstract] | |
Summary of Components of Accounts Payable and Accrued Liabilities | The following table represents the components of accounts payable and accrued liabilities as of December 31: 2021 2020 Accounts payable $ 8,114 $ 4,213 Accrued rebates 38,681 34,247 Accrued compensation and benefits 6,097 5,488 Accrued returns 8,791 5,128 Accrued royalties 750 704 Taxes payable 666 1,026 Accrued regulatory fees 285 397 Accrued legal 2,394 515 Acquired product right 9,000 — Accrued other 2,985 1,277 Total accounts payable and accrued expenses $ 77,763 $ 52,995 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Summary of Property and Equipment | Property and equipment, summarized by major category, consist of the following as of December 31: 2021 2020 Machinery & equipment $ 4,848 $ 4,683 Right of use, building and lease 520 471 Computer equipment & software 640 272 Office furniture & equipment 174 174 Leasehold improvements 43 43 Idle equipment 679 679 Construction in progress — 119 Total 6,904 6,441 Less accumulated depreciation (5,163) (5,023) Total property, plant & equipment, net $ 1,741 $ 1,418 |
Other Intangible Assets (Tables
Other Intangible Assets (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
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: December 31, 2021 Gross Carrying Accumulated Intangible Assets, Remaining Weighted average BELBUCA license and distribution rights 45,000 (22,500) 22,500 5.3 Symproic license and distribution rights 30,636 (6,695) 23,941 10.3 ELYXYB product rights 15,456 (349) 15,107 14.5 Total intangible assets $ 91,092 $ (29,544) $ 61,548 8.5 December 31, 2020 Gross Carrying Accumulated Intangible Assets, Remaining Weighted average Product rights $ 6,050 $ (6,050) $ — BELBUCA license and distribution rights 45,000 (18,000) 27,000 6.0 Symproic license and distribution rights 30,636 (4,260) 26,376 10.8 Total intangible assets $ 81,686 $ (28,310) $ 53,376 7.9 |
Schedule of Estimated Aggregate Future Amortization Expenses for Other Intangible Assets | Estimated aggregate future amortization expenses for other intangible assets for each of the next five years and thereafter are as follows: Years ending December 31, 2022 $ 7,982 2023 7,982 2024 7,982 2025 7,982 2026 7,982 Thereafter 21,636 Total amortization expense 61,548 |
License Agreements and Acquir_2
License Agreements and Acquired Product Rights (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Schedule of Allocation of Purchase Price of License Agreement | The total purchase price was allocated to the acquired asset based on their relative estimated fair values, as follows: ELYXYB acquired product rights $ 15,000 Transaction expenses 456 Total value $ 15,456 The total purchase price was allocated to the acquired asset based on their relative estimated fair values, as follows: Symproic license $ 30,000 Transaction expenses 636 Total value $ 30,636 |
Notes Payable (Tables)
Notes Payable (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Future Maturities of Notes Payable | The following table represents future maturities of the notes payable obligation as of December 31, 2021: 2022 $ 4,615 2023 18,462 2024 24,615 2025 12,308 Total maturities $ 60,000 Unamortized discount and loan costs (1,208) Total notes payable obligation $ 58,792 |
Net Sales By Product (Tables)
Net Sales By Product (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Segment Reporting [Abstract] | |
Summary of Net Sales by Product | The following table presents net sales by product for each of the years ended December 31: Year ended December 31, 2021 2020 2019 BELBUCA $ 148,189 $ 136,128 $ 97,538 % of net product sales 90.0 % 88.1 % 90.4 % Symproic 16,409 14,709 8,061 % of net product sales 10.0 % 9.5 % 7.5 % BUNAVAIL — 3,737 2,289 % of net product sales — % 2.4 % 2.1 % Net product sales $ 164,598 $ 154,574 $ 107,888 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Provision for Income Taxes | The provision for income taxes consisted of the following components for the years ended December 31: 2021 2020 Current: Federal $ — $ (326) State 1,289 578 Total current 1,289 252 Deferred: Federal (54,607) — State (1,920) — Total deferred (56,527) — Total provision for income taxes $ (55,238) $ 252 |
Reconciliation of Federal Statutory Income Tax Rate | Reconciliation of the Federal statutory income tax rate of 21% to the effective rate is as follows: 2021 2020 2019 Federal statutory income tax rate 21.00 % 21.00 % 21.00 % State taxes, net of federal benefit (3.05) 1.75 (0.18) Stock compensation 3.22 4.47 (5.39) Permanent differences-other 0.02 3.77 (7.67) CARES Act 163(j) Modifications — 2.95 — Other (0.97) 3.94 1.71 Increase in valuation allowance (206.70) (36.91) (9.44) (186.48) % 0.97 % 0.03 % |
Significant Components of Deferred Tax Assets and Liabilities | The tax effects of temporary differences and net operating losses that give rise to significant components of deferred tax assets and liabilities consist of the following: December 31, Deferred tax assets 2021 2020 Net operating loss carry-forward $50,535 $58,520 R&D credit 10,930 10,930 Accrued liabilities and other 1,533 1,004 Stock options 954 850 Less: valuation allowance (3,271) (66,495) Net deferred tax assets 60,681 4,809 Deferred tax liabilities Basis difference in intangibles (3,904) (4,696) Basis difference in equipment (250) (113) Total net deferred tax asset $ 56,527 $ — |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Stockholders' Equity Note [Abstract] | |
Summary of Stock Option Activity | Stock option activity for the year ended December 31, 2021 is as follows: Number of Weighted Average Aggregate Outstanding at January 1, 2021 7,060,966 $ 4.55 $ 2,831 Granted in 2021: Officers and Directors 1,678,425 $ 3.88 Employees 2,145,494 4.12 Exercised (160,023) 2.90 Forfeitures (1,112,101) 4.54 Outstanding at December 31, 2021 9,612,761 $ 4.37 $ 520 |
Summary of Stock Options Outstanding | Options outstanding at December 31, 2021 are as follows: Range of Exercise Prices Number Weighted Average Weighted Average Aggregate $1.00 – 5.00 7,367,252 8.15 $ 3.82 $5.01 – 10.00 2,194,085 7.56 $ 5.95 $10.01 – 15.00 29,924 3.14 $ 13.09 $15.01 – 20.00 21,500 2.75 $ 16.47 9,612,761 $ 520 |
Summary of Stock Options Exercisable | Options exercisable at December 31, 2021 are as follows: Range of Exercise Prices Number Weighted Average Weighted Average Aggregate $1.00 – 5.00 3,201,210 7.02 $ 3.61 $5.01 – 10.00 1,252,843 7.1 $ 6.06 $10.01 – 15.00 29,924 3.14 $ 13.09 $15.01 – 20.00 21,500 2.75 $ 16.47 4,505,477 $ 479 |
Summary of Nonvested Stock Options | Nonvested stock options as of December 31, 2021, and changes during the year then ended, are as follows: Nonvested Shares Shares Weighted Average Intrinsic Nonvested at January 1, 2021 4,045,200 Granted 3,823,919 Vested (1,811,558) Forfeited (950,277) Nonvested at December 31, 2021 5,107,284 $ 4.32 $ 41 |
Summary of Restricted Stock Activity | Restricted stock activity during the year ended December 31, 2021 was as follows: Number of Weighted Outstanding at January 1, 2021 940,759 $ 3.71 Granted: Officers and Directors 301,821 $ 3.88 Employees 35,807 $ 3.84 Vested (542,825) $ 3.79 Forfeitures (101,215) $ 4.25 Outstanding at December 31, 2021 634,347 $ 4.09 |
Earnings per Common Share (Tabl
Earnings per Common Share (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Reconciliation of Numerators and Denominators of Basic and Diluted Earnings Per Common Share Computations | The following is a reconciliation of the numerators and denominators of the basic and diluted earnings per common share computations for the years ended December 31, 2021, 2020 and 2019. December 31, 2021 2020 2019 Basic: Net income (loss) attributable to common stockholders, basic $ 84,860 $ 25,711 $ (15,305) Weighted average common shares outstanding 99,320,285 99,830,520 83,213,704 Basic income (loss) per common share $ 0.85 $ 0.26 $ (0.18) Diluted: Effect of dilutive securities: Net income (loss) attributable to common stockholders, diluted $ 84,860 $ 25,711 $ (15,305) Weighted average common shares outstanding 99,320,285 99,830,520 83,213,704 Effect of dilutive options and warrants 3,972,703 5,232,002 — Diluted weighted average common shares outstanding 103,292,988 105,062,522 83,213,704 Diluted income (loss) per common share $ 0.82 $ 0.24 $ (0.18) |
Schedule of Total Outstanding Options, RSUs and Warrants | The following is the total outstanding options, RSUs and warrants for the years ended December 31, 2021, 2020 and 2019, respectively. 2021 2020 2019 Options, RSUs, warrants and convertible preferred stock to purchase Common Stock 14,759,254 12,598,857 11,375,323 |
Nature of Business and Summar_4
Nature of Business and Summary of Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended | |||
Dec. 31, 2021USD ($)contractManufacturingSite$ / shares | Dec. 31, 2020USD ($)$ / shares | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Basis Of Presentation [Line Items] | ||||
Common stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | ||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.001 | |||
Cash | $ 114,300,000 | $ 111,584,000 | ||
Net cash flows from operating activities | 41,000,000 | |||
Stockholders' equity | 187,822,000 | 108,234,000 | $ 69,764,000 | $ 29,742,000 |
Allowance for doubtful accounts receivable | 10,000 | 10,000 | ||
Inventory reserve | 4,180,000 | 2,254,000 | ||
Depreciation | 100,000 | 500,000 | 1,800,000 | |
Impairment charges recognized on finite lived intangibles assets | 0 | 0 | 0 | |
Goodwill impairment charges | $ 0 | 0 | 0 | |
Sales return maximum duration (in months) | 18 months | |||
Offered period for sales return prior to expiration (in months) | 6 months | |||
Offered period for sales return subsequent to expiration (in months) | 12 months | |||
Number of contract manufacturing sites | contractManufacturingSite | 3 | |||
Advertising expenses | $ 20,900,000 | 11,000,000 | 10,800,000 | |
Shipping and handling costs | 23,373,000 | 24,665,000 | 21,590,000 | |
Unrecognized tax benefits | 0 | 0 | ||
Accruals for interest and penalties | 0 | |||
Trade receivables | $ 56,900,000 | |||
Accounts receivable outstanding, percentage | 95.00% | |||
BUNAVAIL | ||||
Basis Of Presentation [Line Items] | ||||
Depreciation | 300,000 | 1,500,000 | ||
Impairment loss | $ 0 | 300,000 | ||
Reserve liability, product returns | 2,200,000 | |||
Shipping and Handling | ||||
Basis Of Presentation [Line Items] | ||||
Shipping and handling costs | $ 50,000 | $ 30,000 | $ 30,000 | |
Minimum | ||||
Basis Of Presentation [Line Items] | ||||
Estimated useful lives of property and equipment | 3 years | |||
Maximum | ||||
Basis Of Presentation [Line Items] | ||||
Estimated useful lives of property and equipment | 10 years |
Nature of Business and Summar_5
Nature of Business and Summary of Significant Accounting Policies - Summary of Company's Customers And Suppliers (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Accounts payable and accrued liabilities | $ 77,763 | $ 52,995 | |
Customer Concentration Risk | Revenue | Customer A | |||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Concentration risk percentage | 34.00% | 33.00% | 34.00% |
Customer Concentration Risk | Revenue | Customer B | |||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Concentration risk percentage | 35.00% | 34.00% | 33.00% |
Customer Concentration Risk | Revenue | Customer C | |||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Concentration risk percentage | 28.00% | 27.00% | 27.00% |
Customer Concentration Risk | Accounts Receivable | Supplier A | |||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Accounts payable and accrued liabilities | $ 15,045 | $ 17,429 | $ 8,142 |
Customer Concentration Risk | Accounts Receivable | Supplier B | |||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Accounts payable and accrued liabilities | $ 4,362 | 3,756 | 1,755 |
Customer Concentration Risk | Accounts Receivable | Supplier C | |||
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Accounts payable and accrued liabilities | $ 2,603 | $ 11,218 |
Nature of Business and Summar_6
Nature of Business and Summary of Significant Accounting Policies - Summary of Inventories (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Accounting Policies [Abstract] | ||
Raw Materials & Supplies | $ 3,674 | $ 3,389 |
Work-in-process | 9,926 | 9,949 |
Finished Goods | 14,291 | 6,359 |
Inventory Reserve | (4,180) | (2,254) |
Total Inventories | $ 23,711 | $ 17,443 |
Nature of Business and Summar_7
Nature of Business and Summary of Significant Accounting Policies - Intangible Assets with Finite Useful Lives (Detail) | 12 Months Ended |
Dec. 31, 2021 | |
Licenses | |
Finite-Lived Intangible Assets [Line Items] | |
Estimated useful lives | 15 years |
BELBUCA license and distribution rights | |
Finite-Lived Intangible Assets [Line Items] | |
Estimated useful lives | 10 years |
Symproic license and distribution rights | |
Finite-Lived Intangible Assets [Line Items] | |
Estimated useful lives | 12 years |
ELYXYB product rights | |
Finite-Lived Intangible Assets [Line Items] | |
Estimated useful lives | 15 years |
Nature of Business and Summar_8
Nature of Business and Summary of Significant Accounting Policies - Black Scholes Options-Pricing Model, Assumptions (Detail) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted average expected life (in years) | 6 years | 6 years | 6 years |
Dividend yield | 0.00% | 0.00% | 0.00% |
Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected price volatility (percentage) | 53.70% | 59.00% | 61.66% |
Risk-free interest rate (percentage) | 0.50% | 0.25% | 1.36% |
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected price volatility (percentage) | 59.87% | 61.76% | 64.10% |
Risk-free interest rate (percentage) | 1.38% | 1.68% | 2.66% |
Nature of Business and Summar_9
Nature of Business and Summary of Significant Accounting Policies- Fair Value of Cash and Cash Equivalents (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Cash and cash equivalents | $ 114,309 |
Level 1 | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Cash and cash equivalents | 114,309 |
Level 2 | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Cash and cash equivalents | 0 |
Level 3 | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Cash and cash equivalents | $ 0 |
Leases - Additional Information
Leases - Additional Information (Details) - Right of use, building and lease ft² in Thousands, $ in Millions | Dec. 31, 2021USD ($) | Oct. 31, 2021 | Nov. 14, 2014ft² |
Lessee, Lease, Description [Line Items] | |||
Lease term (in months) | 89 months | ||
Lease renewal term (in months) | 12 months | ||
Rental space (in square feet) | ft² | 12 | ||
Base rent payable | $ | $ 0.6 |
Leases - Schedule of Components
Leases - Schedule of Components of Lease Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Leases [Abstract] | |||
Operating lease cost | $ 336 | $ 328 | $ 328 |
Variable lease costs | 34 | 19 | 13 |
Total lease cost | $ 370 | $ 347 | $ 341 |
Leases - Schedule of Supplement
Leases - Schedule of Supplemental Cash Flow Information (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Leases [Abstract] | |||
Operating cash flows from operating leases | $ 370 | $ 361 | $ 351 |
Weighted-average remaining lease term operating leases (in years) | 2 years | 2 years | |
Weighted-average discount rate operating leases (percentage) | 11.80% | 11.80% |
Leases - Schedule of Future Min
Leases - Schedule of Future Minimum Lease Payments (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Leases [Abstract] | |
2022 | $ 381 |
2023 | 226 |
Total lease payments | 607 |
Less: Interest | (52) |
Present value of lease liabilities | $ 555 |
Leases - Components of Lease As
Leases - Components of Lease Assets and Liabilities (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Assets | |
Property and equipment, net operating lease-right of use asset | $ 520 |
Liabilities | |
Current liabilities operating lease-current liability | 336 |
Other long-term liabilities operating lease-noncurrent liability | 219 |
Total lease liabilities | $ 555 |
Property and equipment, net operating lease-right of use asset | Property and equipment, net |
Current liabilities operating lease-current liability | Accounts payable and accrued liabilities |
Other long-term liabilities operating lease-noncurrent liability | Other long-term liabilities |
Accounts Payable and Accrued _3
Accounts Payable and Accrued Liabilities - Summary of Components (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Accounts payable | $ 8,114 | $ 4,213 |
Accrued rebates | 38,681 | 34,247 |
Accrued compensation and benefits | 6,097 | 5,488 |
Accrued returns | 8,791 | 5,128 |
Accrued royalties | 750 | 704 |
Taxes payable | 666 | 1,026 |
Accrued regulatory fees | 285 | 397 |
Accrued legal | 2,394 | 515 |
Acquired product right | 9,000 | 0 |
Accrued other | 2,985 | 1,277 |
Total accounts payable and accrued expenses | $ 77,763 | $ 52,995 |
Accounts Payable and Accrued _4
Accounts Payable and Accrued Liabilities - Additional Information (Detail) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Accounts Payable | Supplier Concentration Risk | Three Vendors | ||
Accounts Payable And Accrued Expenses [Line Items] | ||
Concentration risk percentage | 64.00% | 55.00% |
Property and Equipment (Detail)
Property and Equipment (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Property, Plant and Equipment [Line Items] | |||
Right of use, building and lease | $ 520 | $ 471 | |
Total | 6,904 | 6,441 | |
Less accumulated depreciation | (5,163) | (5,023) | |
Total property, plant & equipment, net | 1,741 | 1,418 | |
Depreciation | 100 | 500 | $ 1,800 |
BUNAVAIL | |||
Property, Plant and Equipment [Line Items] | |||
Depreciation | 300 | $ 1,500 | |
Machinery & equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant & equipment, gross | 4,848 | 4,683 | |
Computer equipment & software | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant & equipment, gross | 640 | 272 | |
Office furniture & equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant & equipment, gross | 174 | 174 | |
Leasehold improvements | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant & equipment, gross | 43 | 43 | |
Idle equipment | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant & equipment, gross | 679 | 679 | |
Construction in progress | |||
Property, Plant and Equipment [Line Items] | |||
Property, plant & equipment, gross | $ 0 | $ 119 |
Other Intangible Assets - Summa
Other Intangible Assets - Summary of Other Intangible Assets Net (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | $ 91,092 | $ 81,686 |
Accumulated Amortization | (29,544) | (28,310) |
Intangible Assets, net | 61,548 | 53,376 |
License and Distribution Rights | BELBUCA | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 45,000 | 45,000 |
Accumulated Amortization | (22,500) | (18,000) |
Intangible Assets, net | 22,500 | 27,000 |
License and Distribution Rights | Symproic | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 30,636 | 30,636 |
Accumulated Amortization | (6,695) | (4,260) |
Intangible Assets, net | 23,941 | 26,376 |
Product rights | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 6,050 | |
Accumulated Amortization | (6,050) | |
Intangible Assets, net | $ 0 | |
Product rights | ELYXYB | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Value | 15,456 | |
Accumulated Amortization | (349) | |
Intangible Assets, net | $ 15,107 | |
Remaining Weighted average Useful Life | ||
Finite-Lived Intangible Assets [Line Items] | ||
Remaining Weighed average Useful Life (in years) | 8 years 6 months | 7 years 10 months 24 days |
Remaining Weighted average Useful Life | License and Distribution Rights | BELBUCA | ||
Finite-Lived Intangible Assets [Line Items] | ||
Remaining Weighed average Useful Life (in years) | 5 years 3 months 18 days | 6 years |
Remaining Weighted average Useful Life | License and Distribution Rights | Symproic | ||
Finite-Lived Intangible Assets [Line Items] | ||
Remaining Weighed average Useful Life (in years) | 10 years 3 months 18 days | 10 years 9 months 18 days |
Remaining Weighted average Useful Life | Product rights | ELYXYB | ||
Finite-Lived Intangible Assets [Line Items] | ||
Remaining Weighed average Useful Life (in years) | 14 years 6 months |
Other Intangible Assets - Addit
Other Intangible Assets - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |||
Amortization expense on other intangible assets | $ 7,284 | $ 6,981 | $ 6,981 |
Other Intangible Assets - Sched
Other Intangible Assets - Schedule of Future Amortization (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
2022 | $ 7,982 | |
2023 | 7,982 | |
2024 | 7,982 | |
2025 | 7,982 | |
2026 | 7,982 | |
Thereafter | 21,636 | |
Intangible Assets, net | $ 61,548 | $ 53,376 |
License Agreements and Acquir_3
License Agreements and Acquired Product Rights - Additional Information (Details) - USD ($) $ in Thousands | Aug. 03, 2021 | Apr. 04, 2019 | Jun. 30, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Oct. 04, 2019 |
Finite-Lived Intangible Assets [Line Items] | |||||||
Selling, general and administrative | $ 106,206 | $ 98,827 | $ 86,063 | ||||
ELYXYB product rights | |||||||
Finite-Lived Intangible Assets [Line Items] | |||||||
Up-front payment | $ 6,000 | ||||||
Price of acquisition | 9,000 | ||||||
Additional payment | 9,000 | ||||||
Total milestone payments | 262,000 | ||||||
Minimum | ELYXYB product rights | |||||||
Finite-Lived Intangible Assets [Line Items] | |||||||
Milestone payment, net sales | 4,000 | ||||||
Milestone payment requirement, net sales | 50,000 | ||||||
Maximum | ELYXYB product rights | |||||||
Finite-Lived Intangible Assets [Line Items] | |||||||
Milestone payment, net sales | 100,000 | ||||||
Milestone payment requirement, net sales | $ 1,000,000 | ||||||
Shiongi License And Supply Agreement | |||||||
Finite-Lived Intangible Assets [Line Items] | |||||||
Term of contract (in years) | 2 years | ||||||
Symproic license and distribution rights | Shiongi License And Supply Agreement | |||||||
Finite-Lived Intangible Assets [Line Items] | |||||||
Upfront first installment payment | $ 20,000 | ||||||
Upfront installment hence to be made | $ 10,000 | ||||||
Selling, general and administrative | $ 400 | ||||||
Symproic license and distribution rights | Shiongi License And Supply Agreement | Additional Royalty As A Percentage | Product Concentration Risk | Revenue | |||||||
Finite-Lived Intangible Assets [Line Items] | |||||||
Concentration risk percentage | 1.00% | ||||||
Symproic license and distribution rights | Shiongi License And Supply Agreement | Royalty Agreement Terms | Minimum | Product Concentration Risk | Revenue | |||||||
Finite-Lived Intangible Assets [Line Items] | |||||||
Concentration risk percentage | 8.50% | ||||||
Symproic license and distribution rights | Shiongi License And Supply Agreement | Royalty Agreement Terms | Maximum | Product Concentration Risk | Revenue | |||||||
Finite-Lived Intangible Assets [Line Items] | |||||||
Concentration risk percentage | 17.50% |
License Agreements and Acquir_4
License Agreements and Acquired Product Rights (Details) - USD ($) $ in Thousands | Aug. 03, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Apr. 04, 2019 |
Finite-Lived Intangible Assets [Line Items] | ||||
Acquired assets | $ 61,548 | $ 53,376 | ||
ELYXYB | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
ELYXYB acquired product rights | $ 15,000 | |||
Transaction expenses | 456 | |||
Total value | $ 15,456 | |||
Shiongi License And Supply Agreement | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Acquired assets | $ 30,636 | |||
Shiongi License And Supply Agreement | Symproic license | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Acquired assets | 30,000 | |||
Shiongi License And Supply Agreement | Transaction expenses | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Acquired assets | $ 636 |
License Agreements (Detail)
License Agreements (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Mylan License and Supply Agreement | |||
Other License Agreements And Acquired Product Rights [Line Items] | |||
Milestone payment received | $ 0.9 | $ 0.8 | $ 2.2 |
TTY License and Supply Agreement | |||
Other License Agreements And Acquired Product Rights [Line Items] | |||
Milestone payment received | $ 1.2 | $ 1.1 | $ 1.2 |
Term of the agreement (in years) | 15 years |
Notes Payable - Additional Info
Notes Payable - Additional Information (Detail) - USD ($) $ in Thousands | Sep. 23, 2021 | May 23, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Debt Instrument [Line Items] | |||||
Notes payable repayments | $ 20,000 | $ 0 | $ 67,346 | ||
Bio Pharma Credit Plc | |||||
Debt Instrument [Line Items] | |||||
Maximum borrowing capacity | $ 60,000 | ||||
Additional facility that can be obtained | 20,000 | ||||
Debt instrument, face amount | 60,000 | ||||
Additional borrowing of face amount | 1,800 | ||||
Loan agreement term (in months) | 72 months | ||||
Loan agreement interest only term (in months) | 36 months | ||||
Notes payable repayments | $ 20,000 | ||||
Accrued interest | $ 1,500 | ||||
Bio Pharma Credit Plc | LIBOR | |||||
Debt Instrument [Line Items] | |||||
Additional interest rate (percentage) | 7.50% | ||||
Bio Pharma Credit Plc | LIBOR | Minimum | |||||
Debt Instrument [Line Items] | |||||
Additional interest rate (percentage) | 2.00% | ||||
CRG | |||||
Debt Instrument [Line Items] | |||||
Back end facility fee | $ 5,600 | ||||
CRG | Interest Expense | |||||
Debt Instrument [Line Items] | |||||
Debt issuance costs | 5,200 | ||||
Amortization of discount | 3,900 | ||||
Loan preclosure fees | $ 2,800 |
Notes Payable - Future Maturiti
Notes Payable - Future Maturities of Notes Payable (Detail) - CRG - Line of Credit $ in Thousands | Dec. 31, 2021USD ($) |
Debt Instrument [Line Items] | |
2022 | $ 4,615 |
2023 | 18,462 |
2024 | 24,615 |
2025 | 12,308 |
Total maturities | 60,000 |
Unamortized discount and loan costs | (1,208) |
Total notes payable obligation | $ 58,792 |
Net Sales By Product (Detail)
Net Sales By Product (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Segment Reporting Information [Line Items] | |||
Net product sales | $ 166,703 | $ 156,471 | $ 111,389 |
Net product sales | |||
Segment Reporting Information [Line Items] | |||
Net product sales | 164,598 | 154,574 | 107,888 |
BELBUCA | |||
Segment Reporting Information [Line Items] | |||
Net product sales | 148,189 | 136,128 | 97,538 |
Symproic | |||
Segment Reporting Information [Line Items] | |||
Net product sales | 16,409 | 14,709 | 8,061 |
BUNAVAIL | |||
Segment Reporting Information [Line Items] | |||
Net product sales | $ 0 | $ 3,737 | $ 2,289 |
Revenue | Product Concentration Risk | BELBUCA | |||
Segment Reporting Information [Line Items] | |||
Concentration risk percentage | 90.00% | 88.10% | 90.40% |
Revenue | Product Concentration Risk | Symproic | |||
Segment Reporting Information [Line Items] | |||
Concentration risk percentage | 10.00% | 9.50% | 7.50% |
Revenue | Product Concentration Risk | BUNAVAIL | |||
Segment Reporting Information [Line Items] | |||
Concentration risk percentage | 0.00% | 2.40% | 2.10% |
Income Taxes - Provision for In
Income Taxes - Provision for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Current: | |||
Federal | $ 0 | $ (326) | |
State | 1,289 | 578 | |
Total current | 1,289 | 252 | |
Deferred: | |||
Federal | (54,607) | 0 | |
State | (1,920) | 0 | |
Total deferred | (56,527) | 0 | $ 0 |
Total provision for income taxes | $ (55,238) | $ 252 | $ 5 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax [Line Items] | |||
Statutory income tax rate | 21.00% | 21.00% | 21.00% |
Valuation allowance | $ 3,271,000 | $ 66,495,000 | |
Net decrease in valuation allowance | 63,000,000 | ||
Uncertain income tax positions | 0 | ||
Domestic Country | |||
Income Tax [Line Items] | |||
Operating loss carry forward | 218,000,000 | ||
Net operating loss used to offset taxable income | 1,500,000 | ||
State and Local Jurisdiction | |||
Income Tax [Line Items] | |||
Operating loss carry forward | $ 222,000,000 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Federal Statutory Income Tax Rate (Detail) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |||
Federal statutory income tax rate | 21.00% | 21.00% | 21.00% |
State taxes, net of federal benefit | (3.05%) | 1.75% | (0.18%) |
Stock compensation | 3.22% | 4.47% | (5.39%) |
Permanent differences-other | 0.02% | 3.77% | (7.67%) |
CARES Act 163(j) Modifications | 0.00% | 2.95% | 0.00% |
Other | (0.97%) | 3.94% | 1.71% |
Increase in valuation allowance | (206.70%) | (36.91%) | (9.44%) |
Effective tax rate | (186.48%) | 0.97% | 0.03% |
Income Taxes - Significant Comp
Income Taxes - Significant Components of Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets | ||
Net operating loss carry-forward | $ 50,535 | $ 58,520 |
R&D credit | 10,930 | 10,930 |
Accrued liabilities and other | 1,533 | 1,004 |
Stock options | 954 | 850 |
Less: valuation allowance | (3,271) | (66,495) |
Net deferred tax assets | 60,681 | 4,809 |
Deferred tax liabilities | ||
Basis difference in intangibles | (3,904) | (4,696) |
Basis difference in equipment | (250) | (113) |
Total net deferred tax asset | $ 56,527 | $ 0 |
Stockholder's Equity - Common S
Stockholder's Equity - Common Stock Narrative (Detail) - USD ($) | 12 Months Ended | ||||
Dec. 31, 2021 | Dec. 31, 2020 | Nov. 04, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Common stock, shares authorized (in shares) | 235,000,000 | 235,000,000 | 175,000,000 | 125,000,000 | |
Treasury stock acquired (in shares) | 3,202,690 | ||||
Treasury stock acquired, price (in dollars per share) | $ 3.69 | ||||
Treasury stock value repurchased | $ 11,800,000 | ||||
Common Stock | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Authorized amount of stock to repurchase | $ 25,000,000 |
Stockholder's Equity - Preferre
Stockholder's Equity - Preferred Stock Narrative (Detail) - $ / shares | 1 Months Ended | 12 Months Ended | ||
May 31, 2018 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Authorized shares of preferred stock (in shares) | 5,000,000 | 5,000,000 | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | |||
Preferred Stock Series A | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Authorized shares of preferred stock (in shares) | 2,285,700 | |||
Preferred stock, par value (in dollars per share) | $ 0.001 | |||
Preferred stock converted (in shares) | 2,093,155 | 0 | ||
Preferred shares outstanding (in shares) | 0 | |||
Series B Non-Voting Convertible Preferred Stock | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | |
Preferred shares outstanding (in shares) | 443 | 443 | ||
Sale and issue of preferred stock (in shares) | 5,000 | |||
Purchase price of preferred stock (in dollars per share) | $ 10,000 | |||
Preferred Stock Series B | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Preferred stock converted (in shares) | 0 | |||
Preferred shares outstanding (in shares) | 443 | |||
Conversion price (in dollars per share) | $ 1.80 | |||
Preferred stock conversion to common stock (in shares) | 27,777,778 | |||
Preferred stock period of forced conversion (in days) | 90 days |
Stockholder's Equity - Public O
Stockholder's Equity - Public Offering Narrative (Detail) - USD ($) $ / shares in Units, $ in Thousands | Apr. 15, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Series B issuance, net of issuance costs (in shares) | 12,000,000 | |||
Sales of stock, price per share (in dollars per share) | $ 5 | |||
Sale of stock, number of shares issued in transaction (in shares) | 10,000,000 | |||
Proceeds from issuance of common stock before underwriting discounts, commissions, and other expenses | $ 50,000 | |||
Proceeds from issuance of common stock after underwriting discounts, commissions, and other expenses | 47,600 | |||
Proceeds from issuance of common stock, less underwriters discount | $ 19,000 | $ 0 | $ 0 | $ 48,000 |
IPO | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock options granted to underwriters (in shares) | 1,800,000 |
Stockholder's Equity - Stock Op
Stockholder's Equity - Stock Options Narrative (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Common stock, shares authorized (in shares) | 235,000,000 | 235,000,000 | 175,000,000 | 125,000,000 |
Shares reserved for issuance under 2019 plan (in shares) | 14,000,000 | |||
Options outstanding (in shares) | 9,612,761 | 7,060,966 | ||
Company employees, directors and affiliates stock option exercised (in shares) | 160,023 | |||
Proceeds from common stock | $ 463 | $ 3,369 | $ 2,321 | |
Weighted average grant date fair value of options granted (in dollars per share) | $ 4.01 | $ 5.13 | $ 4.29 | |
Number of options granted in period with exercise price below market price (in shares) | 0 | 0 | 0 | |
Unrecognized compensation cost related to non-vested share-based compensation awards granted | $ 8,300 | |||
Unrecognized compensation cost related to non-vested share-based compensation awards expense period (in years) | 3 years | |||
Employees and Directors Stock Options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Company employees, directors and affiliates stock option exercised (in shares) | 160,000 | 1,400,000 | 800,000 | |
Proceeds from common stock | $ 500 | $ 3,400 | $ 2,300 | |
Intrinsic value of options exercised | $ 100 | $ 3,500 | $ 1,900 | |
2011 Equity Incentive Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Increase in shares of common stock authorized (in shares) | 7,100,000 | |||
Options outstanding (in shares) | 2,677,041 | |||
2011 Equity Incentive Plan | Minimum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Common stock, shares authorized (in shares) | 11,050,000 | |||
2011 Equity Incentive Plan | Maximum | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Common stock, shares authorized (in shares) | 18,150,000 | |||
Equity Incentive Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Weighted Average Remaining Contractual Life (Years) | 10 years |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Number of Shares | ||
Outstanding at beginning of period (in shares) | 7,060,966 | |
Granted (in shares) | 3,823,919 | |
Exercised (in shares) | (160,023) | |
Forfeitures (in shares) | (1,112,101) | |
Outstanding at end of period (in shares) | 9,612,761 | 7,060,966 |
Weighted Average Exercise Price Per Share | ||
Weighted average exercise price per share, outstanding at beginning of period (in dollars per share) | $ 4.55 | |
Weighted average exercise price per share, exercised (in dollars per share) | 2.90 | |
Weighted average exercise price per share, forfeitures (in dollars per share) | 4.54 | |
Weighted average exercise price per share, outstanding at end of period (in dollars per share) | $ 4.37 | $ 4.55 |
Aggregate Intrinsic Value | ||
Aggregate intrinsic value, outstanding balance | $ 520 | $ 2,831 |
Officers and Directors | ||
Number of Shares | ||
Granted (in shares) | 1,678,425 | |
Weighted Average Exercise Price Per Share | ||
Weighted average exercise price per share, granted (in dollars per share) | $ 3.88 | |
Employees | ||
Number of Shares | ||
Granted (in shares) | 2,145,494 | |
Weighted Average Exercise Price Per Share | ||
Weighted average exercise price per share, granted (in dollars per share) | $ 4.12 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Stock Options Outstanding (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||
Number outstanding (in shares) | 9,612,761 | |
Aggregate Intrinsic Value | $ 520 | $ 2,831 |
$1.00 – 5.00 | ||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||
Range of exercise prices, minimum (in dollars per share) | $ 1 | |
Range of exercise prices, maximum (in dollars per share) | $ 5 | |
Number outstanding (in shares) | 7,367,252 | |
Weighted Average Remaining Contractual Life (Years) | 8 years 1 month 24 days | |
Weighted average exercise price (in dollars per share) | $ 3.82 | |
$5.01 – 10.00 | ||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||
Range of exercise prices, minimum (in dollars per share) | 5.01 | |
Range of exercise prices, maximum (in dollars per share) | $ 10 | |
Number outstanding (in shares) | 2,194,085 | |
Weighted Average Remaining Contractual Life (Years) | 7 years 6 months 21 days | |
Weighted average exercise price (in dollars per share) | $ 5.95 | |
$10.01 – 15.00 | ||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||
Range of exercise prices, minimum (in dollars per share) | 10.01 | |
Range of exercise prices, maximum (in dollars per share) | $ 15 | |
Number outstanding (in shares) | 29,924 | |
Weighted Average Remaining Contractual Life (Years) | 3 years 1 month 20 days | |
Weighted average exercise price (in dollars per share) | $ 13.09 | |
$15.01 – 20.00 | ||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | ||
Range of exercise prices, minimum (in dollars per share) | 15.01 | |
Range of exercise prices, maximum (in dollars per share) | $ 20 | |
Number outstanding (in shares) | 21,500 | |
Weighted Average Remaining Contractual Life (Years) | 2 years 9 months | |
Weighted average exercise price (in dollars per share) | $ 16.47 |
Stockholders' Equity - Summar_3
Stockholders' Equity - Summary of Stock Options Exercisable (Detail) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($)$ / sharesshares | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Number outstanding (in shares) | shares | 4,505,477 |
Aggregate Intrinsic Value | $ | $ 479 |
$1.00 – 5.00 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Range of exercise prices, minimum (in dollars per share) | $ 1 |
Range of exercise prices, maximum (in dollars per share) | $ 5 |
Number outstanding (in shares) | shares | 3,201,210 |
Weighted Average Remaining Contractual Life (Years) | 7 years 7 days |
Weighted average exercise price (in dollars per share) | $ 3.61 |
$5.01 – 10.00 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Range of exercise prices, minimum (in dollars per share) | 5.01 |
Range of exercise prices, maximum (in dollars per share) | $ 10 |
Number outstanding (in shares) | shares | 1,252,843 |
Weighted Average Remaining Contractual Life (Years) | 7 years 1 month 6 days |
Weighted average exercise price (in dollars per share) | $ 6.06 |
$10.01 – 15.00 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Range of exercise prices, minimum (in dollars per share) | 10.01 |
Range of exercise prices, maximum (in dollars per share) | $ 15 |
Number outstanding (in shares) | shares | 29,924 |
Weighted Average Remaining Contractual Life (Years) | 3 years 1 month 20 days |
Weighted average exercise price (in dollars per share) | $ 13.09 |
$15.01 – 20.00 | |
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range [Line Items] | |
Range of exercise prices, minimum (in dollars per share) | 15.01 |
Range of exercise prices, maximum (in dollars per share) | $ 20 |
Number outstanding (in shares) | shares | 21,500 |
Weighted Average Remaining Contractual Life (Years) | 2 years 9 months |
Weighted average exercise price (in dollars per share) | $ 16.47 |
Stockholders' Equity - Summar_4
Stockholders' Equity - Summary of Non-Vested Stock Options (Detail) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($)$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Nonvested, Number of Shares [Roll Forward] | |
Nonvested at beginning of period (in shares) | 4,045,200 |
Nonvested, granted (in shares) | 3,823,919 |
Nonvested, vested (in shares) | (1,811,558) |
Nonvested, forfeited (in shares) | (950,277) |
Nonvested at end of period (in shares) | 5,107,284 |
Weighted average grant date fair value, nonvested at end of period (in dollars per share) | $ / shares | $ 4.32 |
Nonvested intrinsic value | $ | $ 41 |
Stockholder's Equity - Stock-Ba
Stockholder's Equity - Stock-Based Compensation Narrative (Detail) - Directors and Employees $ in Millions | 12 Months Ended |
Dec. 31, 2021USD ($)shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Granted (in shares) | shares | 3,823,919 |
Fair market value of shares granted | $ | $ 15.3 |
Term of options granted period (in years) | 10 years |
Minimum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
RSU's vested per performance criteria during period (in years) | 1 year |
Maximum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
RSU's vested per performance criteria during period (in years) | 3 years |
Stockholder's Equity - Restrict
Stockholder's Equity - Restricted Stock Units Narrative (Detail) - Restricted Stock Units (RSUs) $ in Millions | 12 Months Ended |
Dec. 31, 2021USD ($)shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Granted (in shares) | shares | 337,628 |
Fair market value of RSUs granted | $ | $ 1.3 |
Minimum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Vesting period of options (in years) | 1 year |
Maximum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Vesting period of options (in years) | 3 years |
Stockholders' Equity - Summar_5
Stockholders' Equity - Summary of Restricted Stock Activity (Detail) - Restricted Stock Units (RSUs) | 12 Months Ended |
Dec. 31, 2021$ / sharesshares | |
Number of Restricted Shares | |
Outstanding at beginning of period (in shares) | 940,759 |
Granted (in shares) | 337,628 |
Vested (in shares) | (542,825) |
Forfeitures (in shares) | (101,215) |
Outstanding at end of period (in shares) | 634,347 |
Weighted Average Fair Market Value Per RSU (in dollars per share) | |
Weighted average fair market value per RSU, outstanding at beginning of period (in dollars per share) | $ / shares | $ 3.71 |
Weighted average fair market value per RSU, vested (in dollars per share) | $ / shares | 3.79 |
Weighted average fair market value per RSU, forfeitures (in dollars per share) | $ / shares | 4.25 |
Weighted average fair market value per RSU, outstanding at end of period (in dollars per share) | $ / shares | $ 4.09 |
Officers and Directors | |
Number of Restricted Shares | |
Granted (in shares) | 301,821 |
Weighted Average Fair Market Value Per RSU (in dollars per share) | |
Weighted average fair market value per RSU, granted (in dollars per share) | $ / shares | $ 3.88 |
Employees | |
Number of Restricted Shares | |
Granted (in shares) | 35,807 |
Weighted Average Fair Market Value Per RSU (in dollars per share) | |
Weighted average fair market value per RSU, granted (in dollars per share) | $ / shares | $ 3.84 |
Stockholder's Equity - Warrants
Stockholder's Equity - Warrants (Detail) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Warrants outstanding (in shares) | 2,051,033 | ||
Fair value of warrants | $ 4.5 | ||
Warrants granted (in shares) | 0 | 0 | 0 |
Warrants exercised (in shares) | 0 | 0 | 0 |
Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise price of warrants (in dollars per share) | $ 2.38 | ||
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Exercise price of warrants (in dollars per share) | $ 3.42 |
Earnings per Common Share - Rec
Earnings per Common Share - Reconciliation of Numerators and Denominators (Detail) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Basic: | |||
Net income (loss) attributable to common stockholders, basic | $ 84,860 | $ 25,711 | $ (15,305) |
Weighted average common shares outstanding (in shares) | 99,320,285 | 99,830,520 | 83,213,704 |
Basic income (loss) per common share (in dollars per share) | $ 0.85 | $ 0.26 | $ (0.18) |
Effect of dilutive securities: | |||
Net income (loss) attributable to common stockholders, diluted | $ 84,860 | $ 25,711 | $ (15,305) |
Weighted average common stock shares outstanding (in shares) | 99,320,285 | 99,830,520 | 83,213,704 |
Effect of dilutive options and warrants (in shares) | 3,972,703 | 5,232,002 | 0 |
Diluted weighted average common shares outstanding (in shares) | 103,292,988 | 105,062,522 | 83,213,704 |
Diluted income (loss) per common share (in dollars per share) | $ 0.82 | $ 0.24 | $ (0.18) |
Earnings per Common Share - Add
Earnings per Common Share - Additional Information (Detail) - shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Earnings Per Share [Abstract] | |||
Effect of dilutive options and warrants (in shares) | 3,972,703 | 5,232,002 | 0 |
Securities excluded from computation of diluted earnings per share (in shares) | 11,116,195 |
Earnings per Common Share - Sch
Earnings per Common Share - Schedule of Total Outstanding Options, RSUs and Warrants (Detail) - shares | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Earnings Per Share [Abstract] | |||
Options, RSUs, warrants and convertible preferred stock to purchase Common Stock | 14,759,254 | 12,598,857 | 11,375,323 |
Retirement Plan (Detail)
Retirement Plan (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Retirement Benefits [Abstract] | |||
Employers' sponsors contribution retirement plan (percentage) | 90.00% | ||
Contribution to retirement plan, percentage of employee contribution | 100.00% | ||
Percentage of employee contribution to retirement plan | 5.00% | ||
Employers' sponsors contribution retirement plan amount | $ 1.1 | $ 1.1 | $ 1 |
Commitments and Contingencies (
Commitments and Contingencies (Detail) | Mar. 07, 2022purportedStockholder | Mar. 05, 2022case | Feb. 28, 2022case | May 27, 2021patentdocument | Mar. 01, 2021 | Apr. 16, 2020deniedMotion | Sep. 11, 2019purportedStockholder | Feb. 07, 2019decisioninterPartesReview | Sep. 07, 2018patent | Mar. 18, 2016patent | Feb. 08, 2016patent | Oct. 28, 2014petition | Aug. 31, 2021compendia-priceReportingService | Dec. 22, 2016patentabbreviatedNewDrugApplication | Sep. 30, 2007USD ($)qtr | Dec. 31, 2019USD ($) | Dec. 31, 2021USD ($) | Feb. 03, 2022USD ($) |
BUNAVAIL | ||||||||||||||||||
Contingencies And Commitments [Line Items] | ||||||||||||||||||
Petitions filed | petition | 3 | |||||||||||||||||
Maximum petitions | petition | 4 | |||||||||||||||||
Number of decisions on remand purporting | decision | 3 | |||||||||||||||||
Number of previously instituted inter partes review | interPartesReview | 3 | |||||||||||||||||
BELBUCA | ||||||||||||||||||
Contingencies And Commitments [Line Items] | ||||||||||||||||||
Number of motions denied | deniedMotion | 2 | |||||||||||||||||
Teva Pharmaceuticals USA | ||||||||||||||||||
Contingencies And Commitments [Line Items] | ||||||||||||||||||
Number of invalid patents | patent | 3 | 2 | ||||||||||||||||
Number of patents allegedly infringed upon | patent | 3 | |||||||||||||||||
Number of abbreviated new drug applications (ANDA) | abbreviatedNewDrugApplication | 3 | |||||||||||||||||
Alvogen | ||||||||||||||||||
Contingencies And Commitments [Line Items] | ||||||||||||||||||
Number of patent invalidity defenses | patent | 3 | 3 | ||||||||||||||||
Bench trial period (in days) | 3 days | |||||||||||||||||
Number of documents | document | 2 | |||||||||||||||||
Number of price reporting services offered | compendia-priceReportingService | 5 | |||||||||||||||||
Drachman v. BioDelivery Sciences International, Inc. | ||||||||||||||||||
Contingencies And Commitments [Line Items] | ||||||||||||||||||
Number of purported stockholders | purportedStockholder | 2 | |||||||||||||||||
Original term of directors (in years) | 1 year | |||||||||||||||||
Current term of directors (in years) | 3 years | |||||||||||||||||
Merger Litigation | Subsequent Event | ||||||||||||||||||
Contingencies And Commitments [Line Items] | ||||||||||||||||||
Number of purported stockholders | purportedStockholder | 3 | |||||||||||||||||
Number of cases filed by purported shareholders | case | 2 | 2 | ||||||||||||||||
Bankruptcy Matter | Subsequent Event | ||||||||||||||||||
Contingencies And Commitments [Line Items] | ||||||||||||||||||
Expected loss on recovery of preferential payments | $ 45,186.9 | |||||||||||||||||
CDC | ||||||||||||||||||
Contingencies And Commitments [Line Items] | ||||||||||||||||||
Royalties received | $ 20,000 | |||||||||||||||||
Granted royalty on sales of the next BEMA product percentage | 1.00% | |||||||||||||||||
Net sales of next BEMA Product | $ 7,500,000 | |||||||||||||||||
Royalty expense payment period (in consecutive quarters) | qtr | 3 | |||||||||||||||||
Minimum | CDC | ||||||||||||||||||
Contingencies And Commitments [Line Items] | ||||||||||||||||||
Royalties received | $ 375,000 | |||||||||||||||||
Opioid PMR Consortium | ||||||||||||||||||
Contingencies And Commitments [Line Items] | ||||||||||||||||||
Participation expense | $ 4,300,000 |
Subsequent Events (Details)
Subsequent Events (Details) - $ / shares | Feb. 14, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Subsequent Event [Line Items] | |||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | |
Collegium Pharmaceutical, Inc. | Subsequent Event | Purchaser | |||
Subsequent Event [Line Items] | |||
Commencement of cash tender offer (in business days) | 10 days | ||
Common stock, par value (in dollars per share) | $ 0.001 | ||
Offer price (in dollars per share) | $ 5.60 | ||
Period cash tender offer remains open (in business days) | 20 days | ||
Obligation to purchase outstanding shares in the cash tender offer (in shares) | 1 | ||
Number of shares of common stock issued and outstanding (percentage) | 50.00% |
Schedule II - Valuation and Q_2
Schedule II - Valuation and Qualifying Accounts and Reserves (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Valuation allowance for deferred tax assets | |||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Balance at beginning of the period | $ 66,495 | $ 76,079 | $ 75,458 |
Charged to income | (56,527) | (9,584) | 621 |
Charged to other accounts | 0 | 0 | 0 |
Deductions | (6,697) | 0 | 0 |
Balance at the end of the period | 3,271 | 66,495 | 76,079 |
Allowance for rebates | |||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Balance at beginning of the period | 34,247 | 29,429 | 12,261 |
Charged to income | 135,315 | 113,854 | 80,404 |
Charged to other accounts | (55) | 2,565 | |
Deductions | (130,826) | (109,036) | (65,801) |
Balance at the end of the period | 38,681 | 34,247 | 29,429 |
Allowance for distribution fees | |||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Balance at beginning of the period | 5,502 | 6,005 | 4,018 |
Charged to income | 30,397 | 27,581 | 29,552 |
Charged to other accounts | 55 | (901) | |
Deductions | (30,417) | (28,084) | (26,664) |
Balance at the end of the period | 5,537 | 5,502 | 6,005 |
Allowance for inventory obsolescence | |||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |||
Balance at beginning of the period | 2,254 | 384 | 187 |
Charged to income | 4,340 | 1,870 | 289 |
Charged to other accounts | 0 | 0 | 0 |
Deductions | (2,414) | 0 | (92) |
Balance at the end of the period | $ 4,180 | $ 2,254 | $ 384 |
Uncategorized Items - bdsi-2021
Label | Element | Value |
Right-of-Use Asset Obtained in Exchange for Operating Lease Liability | us-gaap_RightOfUseAssetObtainedInExchangeForOperatingLeaseLiability | $ 900,000 |