Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Feb. 29, 2020 | Jun. 30, 2019 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2019 | ||
Entity Registrant Name | VIVUS INC | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Interactive Data Current | Yes | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 10,648,947 | ||
Entity Public Float | $ 39,767,025 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0000881524 | ||
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 32,649 | $ 30,411 |
Available-for-sale securities | 0 | 80,838 |
Accounts receivable, net | 22,338 | 25,608 |
Inventories, net | 33,679 | 23,132 |
Prepaid expenses and other current assets | 8,134 | 7,538 |
Total current assets | 96,800 | 167,527 |
Fixed assets, net | 233 | 341 |
Right-of-use assets | 1,135 | |
Intangible and other non-current assets | 120,140 | 134,279 |
Total assets | 218,308 | 302,147 |
Current liabilities: | ||
Accounts payable | 7,726 | 8,921 |
Accrued and other liabilities | 32,398 | 33,044 |
Deferred revenue | 1,249 | 1,235 |
Current portion of lease liability | 767 | |
Current portion of long-term debt | 183,006 | |
Total current liabilities | 225,146 | 43,200 |
Long-term debt | 58,721 | 294,446 |
Deferred revenue, net of current portion | 3,063 | 4,290 |
Lease liability, net of current portion | 602 | |
Non-current accrued and other liabilities | 0 | 234 |
Total liabilities | 287,532 | 342,170 |
Commitments and contingencies | ||
Stockholders' deficit | ||
Preferred stock; $.001 par value; 5,000 shares authorized; no shares issued and outstanding at December 31, 2019 and 2018 | ||
Common stock; $.001 par value; 200,000 shares authorized; 10,649 and 10,636 shares issued and outstanding at December 31, 2019 and 2018, respectively | 11 | 11 |
Additional paid-in capital | 842,808 | 840,751 |
Accumulated other comprehensive loss | (35) | (270) |
Accumulated deficit | (912,008) | (880,515) |
Total stockholders' deficit | (69,224) | (40,023) |
Total liabilities and stockholders' deficit | $ 218,308 | $ 302,147 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
CONDENSED CONSOLIDATED BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 10,649,000 | 10,636,000 |
Common stock, shares outstanding | 10,649,000 | 10,636,000 |
Consolidated Statements Of Oper
Consolidated Statements Of Operations - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Revenue: | |||
Total revenue | $ 69,760 | $ 65,062 | $ 65,373 |
Operating expenses: | |||
Cost of goods sold (excluding amortization) | 15,671 | 14,613 | 16,643 |
Amortization of intangible assets | 14,552 | 8,640 | 544 |
Sales and marketing | 17,968 | 13,970 | 16,638 |
General and administrative | 22,071 | 23,971 | 23,492 |
Research and development | 10,467 | 7,347 | 5,263 |
Total operating expenses | 80,729 | 68,541 | 62,580 |
(Loss) Income from operations | (10,969) | (3,479) | 2,793 |
Interest expense | 20,728 | 33,876 | 33,231 |
Gain on extinguishment of debt | (1,427) | ||
Other (income) expense, net | (215) | 970 | 71 |
Interest and other expense, net | 20,513 | 33,419 | 33,302 |
Loss before income taxes | (31,482) | (36,898) | (30,509) |
Provision for income taxes | 21 | 52 | 2 |
Net loss | $ (31,503) | $ (36,950) | $ (30,511) |
Basic and diluted net loss per share: | |||
Basic and diluted net loss per share (in dollars per share) | $ (2.96) | $ (3.48) | $ (2.89) |
Shares used in per share computation: | |||
Basic and diluted (in shares) | 10,641 | 10,621 | 10,574 |
Net Product Revenue | |||
Revenue: | |||
Total revenue | $ 59,049 | $ 56,784 | $ 44,983 |
License and Milestone Revenue | |||
Revenue: | |||
Total revenue | 2,500 | 7,500 | |
Supply Revenue | |||
Revenue: | |||
Total revenue | 4,634 | 4,863 | 10,407 |
Royalty Revenue | |||
Revenue: | |||
Total revenue | $ 3,577 | $ 3,415 | $ 2,483 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | |||
Net loss | $ (31,503) | $ (36,950) | $ (30,511) |
Other comprehensive loss: | |||
Unrealized gain on securities, net of taxes | 271 | 338 | 8 |
Translation adjustment | (36) | ||
Comprehensive loss | $ (31,268) | $ (36,612) | $ (30,503) |
Consolidated Statements Of Stoc
Consolidated Statements Of Stockholders' Equity - USD ($) $ in Thousands | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Total |
Balances at Dec. 31, 2016 | $ 10 | $ 831,845 | $ (616) | $ (813,054) | $ 18,185 |
Balances (in shares) at Dec. 31, 2016 | 10,483,000 | ||||
Sale of common stock through employee stock purchase plan | 38 | 38 | |||
Sale of common stock through employee stock purchase plan (in shares) | 5,000 | ||||
Vesting of restricted stock units (in shares) | 115,000 | ||||
Vesting of restricted stock units, value | $ 1 | (1) | |||
Share-based compensation expense | 2,942 | 2,942 | |||
Net unrealized (loss) gain on securities | 8 | 8 | |||
Net income (loss) | (30,511) | (30,511) | |||
Balances at Dec. 31, 2017 | $ 11 | 834,824 | (608) | (843,565) | (9,338) |
Balances (in shares) at Dec. 31, 2017 | 10,603,000 | ||||
Sale of common stock through employee stock purchase plan | 41 | 41 | |||
Sale of common stock through employee stock purchase plan (in shares) | 11,000 | ||||
Exercise of common stock options for cash | 78 | 78 | |||
Exercise of common stock options for cash (in shares) | 10,000 | ||||
Vesting of restricted stock units (in shares) | 12,000 | ||||
Share-based compensation expense | 3,285 | 3,285 | |||
Warrants issued for acquisition of PANCREAZE | 828 | 828 | |||
Warrants issued in association with the issuance of debt | 1,695 | 1,695 | |||
Net unrealized (loss) gain on securities | 338 | 338 | |||
Net income (loss) | (36,950) | (36,950) | |||
Balances at Dec. 31, 2018 | $ 11 | 840,751 | (270) | (880,515) | $ (40,023) |
Balances (in shares) at Dec. 31, 2018 | 10,636,000 | 10,636,000 | |||
Sale of common stock through employee stock purchase plan | 31 | $ 31 | |||
Sale of common stock through employee stock purchase plan (in shares) | 12,000 | ||||
Vesting of restricted stock units (in shares) | 1,000 | ||||
Share-based compensation expense | 2,026 | 2,026 | |||
Translation adjustment | (36) | (36) | |||
Net unrealized (loss) gain on securities | 271 | 271 | |||
Cumulative effect of accounting change | 10 | 10 | |||
Net income (loss) | (31,503) | (31,503) | |||
Balances at Dec. 31, 2019 | $ 11 | $ 842,808 | $ (35) | $ (912,008) | $ (69,224) |
Balances (in shares) at Dec. 31, 2019 | 10,649,000 | 10,649,000 |
Consolidated Statements Of Cash
Consolidated Statements Of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities: | |||
Net loss | $ (31,503) | $ (36,950) | $ (30,511) |
Adjustments to reconcile net loss to net cash used for operating activities: | |||
Depreciation and amortization | 14,702 | 8,875 | 811 |
Amortization of debt issuance costs and discounts | (4,070) | 18,228 | 20,442 |
Amortization of discount or premium on available-for-sale securities | 502 | (559) | (768) |
Share-based compensation expense | 2,026 | 3,285 | 2,942 |
Gain on extinguishment of debt | (1,427) | ||
Changes in assets and liabilities: | |||
Accounts receivable | 2,857 | (13,421) | (2,709) |
Inventories | (12,623) | (5,849) | (1,526) |
Prepaid expenses and other assets | (201) | (370) | 1,069 |
Accounts payable | (1,195) | (1,151) | 5,365 |
Accrued and other liabilities | 1,248 | 5,838 | 5,859 |
Deferred revenue | (1,213) | (1,224) | (18,874) |
Net cash used for operating activities | (30,474) | (23,607) | (16,364) |
Investing activities: | |||
Fixed asset purchases | (42) | (34) | (21) |
Acquisition of PANCREAZE license | (135,000) | ||
Purchases of available-for-sale securities | (16,879) | (41,506) | (31,097) |
Proceeds from maturity of available-for-sale securities | 42,087 | 58,101 | 37,470 |
Proceeds from sales of available-for-sale securities | 56,403 | 62,289 | 17,660 |
Net cash provided by (used for) investing activities | 81,569 | (56,150) | 24,012 |
Financing activities: | |||
Net proceeds from debt issuance | 107,991 | ||
Repayments of notes payable | (48,649) | (64,334) | (26,077) |
Principal payments of financing leases | (203) | ||
Net proceeds from exercise of common stock options | 78 | ||
Sale of common stock through employee stock purchase plan | 31 | 41 | 38 |
Net cash (used for) provided by financing activities | (48,821) | 43,776 | (26,039) |
Effect of exchange rates on cash and cash equivalents | (36) | ||
Net increase (decrease) in cash and cash equivalents | 2,238 | (35,981) | (18,391) |
Cash and cash equivalents: | |||
Beginning of year | 30,411 | 66,392 | 84,783 |
End of year | 32,649 | 30,411 | 66,392 |
Supplemental cash flow disclosure: | |||
Interest paid | 18,315 | 18,445 | 15,350 |
Income taxes paid | 46 | 60 | 47 |
Non-cash investing activities: | |||
Unrealized gain on securities | $ 271 | $ 338 | $ 8 |
Business and Significant Accoun
Business and Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2019 | |
BASIS OF PRESENTATION | |
Business and Significant Accounting Policies | Note 1 Business VIVUS is a specialty pharmaceutical company with three approved therapies (Qsymia®, PANCREAZE®/PANCREASE® MT and STENDRA®/SPEDRA) and one product candidate in active clinical development (VI-0106). Qsymia (phentermine and topiramate extended release) is approved by the U.S. Food and Drug Administration (“FDA”) for chronic weight management. In June 2018, the Company acquired the U.S. and Canadian commercial rights for PANCREAZE/PANCREASE MT (pancrelipase), which is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions. STENDRA (avanafil) is approved by FDA for erectile dysfunction (“ED”), and by the European Commission (“EC”) under the trade name SPEDRA, for the treatment of ED. The Company commercializes Qsymia and PANCREAZE in the U.S. through a specialty sales force supported by an internal commercial team. The Company licenses the commercial rights to STENDRA/SPEDRA in the U.S., EU and other countries. VI-0106 (tacrolimus) is in active clinical development and is being studied in patients with pulmonary arterial hypertension (“PAH”). When reference is made to the “Company” or “VIVUS” in these footnotes, it refers to the Delaware corporation, or VIVUS, Inc., and, unless the context otherwise requires, its California predecessor, as well as all of its consolidated subsidiaries. Liquidity and Ability to Continue as a Going Concern At December 31, 2019, the Company’s accumulated deficit was approximately $912.0 million and its cash and cash equivalents were $32.6 million. As of December 31, 2019, the Company had a total of $241.7 million in debt, $181.4 million of which is due May 2020. See Note 13 for additional information regarding the Company’s debt. The Company does not currently have sufficient cash and/or credit facilities in place to pay the debt due May 2020 and is actively pursuing funding, which may come through public or private debt or equity financings, collaborations, sale of assets or other available financing sources. Such funding may not be available on acceptable terms, or at all. If additional funds are raised by issuing equity securities, substantial dilution to existing stockholders may result. If adequate funds are not available, the Company will not be able to continue its operations at its current level and may be required to relinquish rights to certain of its technologies, product candidates or products that it would otherwise seek to develop on its own. It might also be required to delay, reduce the scope of or eliminate one or more of its commercialization or development programs or obtain funds through collaborations with others that are on unfavorable terms or restructure the Company in other ways that may not be favorable. Even if adequate funds become available, the Company may need to raise additional funds in the near future to finance operations and pursue development and commercial opportunities. The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. The Company’s coming debt maturities as well as its negative cash flow from operations and accumulated deficit raise substantial doubt about its ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Management has evaluated all events and transactions that occurred after December 31, 2019, through the date these consolidated financial statements were issued. There were no events or transactions occurring during this period that require recognition or disclosure in these consolidated financial statements. The Company operates in a single segment, the development and commercialization of novel therapeutic products. Significant Accounting Policies Principles of Consolidation The consolidated financial statements include the accounts of VIVUS, Inc., and its wholly owned subsidiaries. All significant intercompany transactions and balances have been eliminated in consolidation. Reverse Stock Split On September 10, 2018, the Company effected a one-for-10 reverse stock split of its common stock. As a result of the reverse stock split, every 10 shares of the Company’s pre-reverse split common stock issued and outstanding was combined and converted into one issued and outstanding share of post-reverse split common stock without any change in the par value of the shares. Accordingly, an amount equal to the par value of the decreased shares resulting from the reverse stock split was reclassified from “Common stock” to “Additional paid-in capital.” No fractional shares were issued as a result of the reverse stock split; any fractional shares that would have resulted were rounded up to the nearest whole share. Proportionate voting rights and other rights of stockholders were not affected by the reverse stock split, other than as a result of the rounding up of potential fractional shares. All stock options, warrants and restricted stock units outstanding and common stock reserved for issuance under the Company’s equity incentive plans immediately prior to the reverse stock split were adjusted by dividing the number of affected shares of common stock by 10 and, where applicable, multiplying the exercise price by 10. All share and per share amounts related to common stock, stock options, warrants and restricted stock units have been restated for all periods to give retroactive effect to the reverse stock split. Use of Estimates The Company’s consolidated financial statements are prepared in accordance with U.S. generally accepted accounting principles as set forth in the FASB’s Accounting Standards Codification, with consideration given to the various staff accounting bulletins and other applicable guidance issued by the U.S. Securities and Exchange Commission. These accounting principles require management to make certain estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, the Company evaluates its estimates, including critical accounting policies or estimates related to the recognition of revenue and related reserves, available‑for‑sale securities, debt instruments, contingencies, litigation, inventories, research and development expenses, income taxes, and share‑based compensation. The Company bases its estimates on historical experience, information received from third parties and on various market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ significantly from those estimates under different assumptions or conditions. Cash and Cash Equivalents The Company considers highly liquid investments with maturities from the date of purchase of three months or less to be cash equivalents. At December 31, 2019 and 2018, all cash equivalents were invested in money market funds or U.S. Treasury securities. These investments are recorded at fair value. See Note 3. Available‑for‑Sale Securities The Company determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation at each balance sheet date. Marketable securities have been classified and accounted for as available‑for‑sale. The Company may or may not hold securities with stated maturities greater than 12 months until maturity. In response to changes in the availability of and the yield on alternative investments as well as liquidity requirements, the Company may sell these securities prior to their stated maturities. As these securities are viewed by the Company as available to support current operations, securities with maturities beyond 12 months are classified as current assets. Debt securities are carried at fair value, with the unrealized gains and losses, net of taxes, reported as a component of stockholders’ equity (deficit), unless the decline in value is deemed to be other than temporary, in which case such securities are written down to fair value and the loss is charged to other‑than‑temporary loss on impaired securities. The Company periodically evaluates its investment securities for other‑than‑temporary declines based on quantitative and qualitative factors. Any losses that are deemed other-than-temporary are recognized as a non-operating loss. To date, the Company has not had any other-than-temporary declines in the value of any of the securities in its investment portfolio. Realized gains or losses on the sale of marketable securities are determined on a specific identification method, and such gains and losses are reflected as a component of interest expense. See Note 3. Fair Value Measurements The Company’s financial instruments include cash equivalents, available‑for‑sale securities, accounts receivable, accounts payable, accrued liabilities and debt. Available‑for‑sale securities are carried at fair value. The carrying value of cash equivalents, accounts receivable, accounts payable and accrued liabilities approximate their fair value due to the relatively short‑term nature of these instruments. Debt instruments are initially recorded at face value, with stated interest and amortization of debt issuance discounts and costs recognized as interest expense, which currently approximates fair value. Issuance costs related to the conversion option of the Company’s convertible notes were charged to additional paid‑in capital. The portion of the issuance costs related to the debt component is being amortized and recorded as additional interest expense over the expected life of the convertible notes. In connection with the issuance of the convertible notes, the Company entered into capped call transactions with certain counterparties affiliated with the underwriters. See Note 13. Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash, cash equivalents, available‑for‑sale‑securities, and accounts receivable. The Company has established guidelines to limit its exposure to credit risk by placing investments in high credit quality money market funds, U.S. Treasury securities or corporate debt securities and by placing investments with maturities that maintain safety and liquidity within the Company’s liquidity needs. The Company has also established guidelines for the issuance of credit to existing and potential customers. Accounts Receivable, Allowances for Doubtful Accounts and Cash Discounts The Company extends credit to its customers for product sales resulting in accounts receivable. Customer accounts are monitored for past due amounts. Amounts that are determined to be uncollectible are written off against the allowance for doubtful accounts. Allowances for doubtful accounts are estimated based upon past due amounts, historical losses and existing economic factors, and are adjusted periodically. Historically, the Company has not had any significant uncollected accounts. The Company offers cash discounts to its customers, generally 2% of the sales price, as an incentive for prompt payment. The estimate of cash discounts is recorded at the time of sale. The Company accounts for the cash discounts by reducing revenue and accounts receivable by the amount of the discounts it expects the customers to take. The accounts receivable are reported in the consolidated balance sheets, net of the allowances for doubtful accounts and cash discounts. There is no allowance for doubtful accounts at December 31, 2019 or 2018. The allowance for cash discounts is $252,000 and $152,000 at December 31, 2019 and 2018, respectively. Inventories Inventories are valued at the lower of cost or net realizable value. Cost is determined using the first‑in, first‑out method using a weighted average cost method calculated for each production batch. Inventory includes the cost of the active pharmaceutical ingredients (“API”), raw materials and third‑party contract manufacturing and packaging services. Indirect overhead costs associated with production and distribution are allocated to the appropriate cost pool and then absorbed into inventory based on the units produced or distributed, assuming normal capacity, in the applicable period. Inventory costs of product shipped to customers, but not yet recognized as revenue, are recorded within inventories on the consolidated balance sheets and are subsequently recognized to cost of goods sold when revenue recognition criteria have been met. The Company’s policy is to write down inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value and inventory in excess of expected requirements. The estimate of excess quantities is subjective and primarily dependent on the Company’s estimates of future demand for a particular product. If the estimate of future demand is inaccurate based on lower actual sales, the Company may increase the write down for excess inventory for that product and record a charge to inventory impairment. Property and Equipment Property and equipment is stated at cost and includes computers and software, furniture and fixtures, leasehold improvements and manufacturing equipment. Depreciation is computed using the straight‑line method over the estimated useful lives of two to seven years for computers and software, furniture and fixtures and manufacturing equipment. Leasehold improvements are amortized using the straight‑line method over the shorter of the remaining lease term or the estimated useful lives. Expenditures for repairs and maintenance, which do not extend the useful life of the property and equipment, are expensed as incurred. Gains and losses associated with dispositions are reflected as a non-operating gain or loss in the accompanying consolidated statements of operations. Long‑lived assets, including property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to an estimate of undiscounted future cash flows expected to be generated by the asset. If the carrying amount of the asset exceeds its estimated future cash flows, an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the asset. To date, the Company has had no significant write-offs of long-lived assets. Debt Issuance Costs Debt issuance costs, which are presented in the consolidated balance sheet as a direct deduction from the carrying amount of the debt liability, are amortized as interest expense using the effective-interest method over the expected term of the debt. Revenue Recognition See Note 2. Cost of Goods Sold Cost of goods sold for units shipped to customers includes the inventory costs of API, third‑party contract manufacturing costs, packaging and distribution costs, royalties, cargo insurance, freight, shipping, handling and storage costs, and overhead costs of the employees involved with production. Research and Development Expenses Research and development (“R&D”) expenses include license fees, related compensation, consultants’ fees, facilities costs, administrative expenses related to R&D activities and clinical trial costs incurred by clinical research organizations or CROs, and research institutions under agreements that are generally cancelable, among other related R&D costs. The Company also records accruals for estimated ongoing clinical trial costs. Clinical trial costs represent costs incurred by CRO and clinical sites and include advertising for clinical trials and patient recruitment costs. These costs are recorded as a component of R&D expenses and are expensed as incurred. Under the Company’s agreements, progress payments are typically made to investigators, clinical sites and CROs. The Company analyzes the progress of the clinical trials, including levels of patient enrollment, invoices received and contracted costs when evaluating the adequacy of accrued liabilities. Significant judgments and estimates must be made and used in determining the accrued balance in any accounting period. Actual results could differ from those estimates under different assumptions. Revisions are charged to expense in the period in which the facts that give rise to the revision become known. In addition, the Company has obtained rights to patented intellectual properties under several licensing agreements for use in research and development activities. Non‑refundable licensing payments made for intellectual properties that have no alternative future uses are expensed to research and development as incurred. Advertising Expenses Advertising expenses are expensed as incurred. The Company incurred advertising and sales promotion costs of $1.9 million, $2.1 million and $3.2 million in 2019, 2018 and 2017, respectively. Share‑Based Compensation Compensation expense is recognized for share-based payments, including stock options, restricted stock units and shares issued under the employee stock purchase plan, using a fair‑value based method. The Company estimates the fair value of share‑based payment awards on the date of the grant using the Black‑Scholes option‑pricing model, which requires the Company to estimate the expected term of the award, the expected volatility, the risk-free interest rate and the expected dividends. The expected term, which represents the period of time that options granted are expected to be outstanding, is derived by analyzing the historical experience of similar awards, giving consideration to the contractual terms of the share‑based awards, vesting schedules and expectations of future employee behavior. Expected volatilities are estimated using the historical share price performance over the expected term of the option, which are adjusted as necessary for any other factors which may reasonably affect the volatility of VIVUS’s stock in the future. The risk‑free interest rate is based on the U.S. Treasury yield in effect at the time of the grant for the expected term of the award. The Company does not anticipate paying any dividends in the near future. The Company develops pre‑vesting forfeiture assumptions based on an analysis of historical data and expected future activity. Income Taxes The Company makes certain estimates and judgments in determining income tax expense for financial statement purposes. These estimates and judgments occur in the calculation of certain tax assets and liabilities, which arise from differences in the timing of recognition of revenue and expense for tax and financial statement purposes. As part of the process of preparing the Company’s consolidated financial statements, the Company is required to estimate its income taxes in each of the jurisdictions in which the Company operates. This process involves the Company estimating its current tax exposure under the most recent tax laws and assessing temporary differences resulting from differing treatment of items for tax and accounting purposes. These differences result in deferred tax assets and liabilities, which are included in the Company’s consolidated balance sheets. The Company assesses the likelihood that it will be able to recover its deferred tax assets by considering all available evidence, both positive and negative, including historical levels of income, expectations and risks associated with estimates of future taxable income and ongoing prudent and feasible tax planning strategies in assessing the need for a valuation allowance. If it is not more likely than not that the Company will recover its deferred tax assets, the Company will increase its provision for taxes by recording a valuation allowance against the deferred tax assets that the Company estimates will not ultimately be recoverable. Realization of deferred tax assets by the Company is dependent upon the amount and timing of the generation of future taxable income, if any. As a result of the Company’s analysis of all available evidence, both positive and negative, as of December 31, 2019, it was considered more likely than not that the Company’s deferred tax assets would not be realized. As a result, the Company’s net deferred tax assets have been fully offset by a valuation allowance. Should there be a change in the Company’s ability to recover its deferred tax assets, the Company would recognize a benefit to its tax provision in the period in which the Company determines that it is more likely than not that it will recover its deferred tax assets. The Company will continue to analyze the evidence each quarter during 2020 to determine whether it becomes more likely than not that all or a portion of its deferred tax assets are realizable. The Company recognizes interest and penalties accrued on any unrecognized tax benefits as a component of its provision for income taxes. See Note 18. Foreign Currency Transactions Transactions in foreign currencies are initially recorded at the rates of exchange prevailing on the dates of the transactions. Monetary assets and liabilities denominated in foreign currencies are retranslated into the Company’s functional currency at the rates prevailing on the balance sheet date. Non‑monetary items carried at fair value that are denominated in foreign currencies are retranslated at the rates prevailing on the initial transaction dates. Exchange differences arising on the settlement of monetary items, and on the retranslation of monetary items, are included in the profit and loss account for the period. Exchange differences arising on the retranslation of non‑monetary items carried at fair value are included in other expense in the accompanying consolidated statements of operations for the period. Contingencies and Litigation The Company is periodically involved in disputes and litigation related to a variety of matters. When it is probable that the Company will experience a loss, and that loss is quantifiable, the Company records appropriate reserves. The Company records legal fees and costs as an expense when incurred. Intangible Assets The Company records acquired intangible assets at cost and amortizes them over the estimated useful life of the asset. When events or changes in circumstances indicate that the carrying value of intangible assets may not be recoverable, the Company evaluates such impairment if the net book value of such assets exceeds the future undiscounted cash flows attributable to such assets. Should an impairment exist, the impairment loss would be measured based on the excess carrying value of the asset over the asset’s fair value or discounted estimates of future cash flows attributable to the assets. To date, the Company has recorded no impairment losses on its intangible assets. See Note 8. Net Loss Per Share The Company computes basic net loss per share applicable to common stockholders based on the weighted average number of common shares outstanding during the period. Diluted net loss per share is based on the weighted average number of common and common equivalent shares, which represent shares that may be issued in the future upon the exercise of outstanding stock options or upon a net share settlement of the Company’s Convertible Notes. Common share equivalents are excluded from the computation in periods in which they have an anti‑dilutive effect. Stock options for which the price exceeds the average market price over the period have an anti‑dilutive effect on net loss per share and, accordingly, are excluded from the calculation. As discussed in Note 13, the triggering conversion conditions that allow holders of the Convertible Notes to convert have not been met. If such conditions are met and the note holders opt to convert, the Company may choose to pay in cash, common stock, or a combination thereof. However, if this occurs, the Company has the intent and ability to net share settle this debt security; thus the Company uses the treasury stock method for net loss per share purposes. Due to the effect of the capped call instrument purchased in relation to the Convertible Notes, there would be no net shares issued until the market value of the Company’s stock exceeds $20 per share, and thus no impact on diluted net loss per share. Further, when there is a net loss, other potentially dilutive common equivalent shares are not included in the calculation of net loss per share since their inclusion would be anti‑dilutive. The following table presents the computation of basic and diluted net loss per share (in thousands, except per share amounts): 2019 2018 2017 Net loss $ $ $ Basic and Diluted: Weighted-average shares outstanding Basic and diluted net loss per share $ $ $ For the years ended December 31, 2019, 2018, and 2017, potentially dilutive outstanding stock options and RSUs of 2,847,000, 2,168,000 and 1,350,000, respectively, were not included in the computation of diluted net loss per share because the effect would have been anti‑dilutive. Recent Accounting Pronouncement Adopted In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2016-02, Leases (Topic 842), which modifies the accounting by lessees for all leases with a term greater than 12 months. This standard requires lessees to recognize on the balance sheet the assets and liabilities for the rights and obligations created by those leases. The Company adopted this standard on January 1, 2019 using the modified retrospective transition method, and as a result did not adjust comparative periods. The Company has one large operating lease for its corporate headquarters and several smaller leases, including financing leases for its automobile fleet and copiers. See Note 14. Recent Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued Accounting Standards Update 2016-13, Measurement of Credit Losses on Financial Instruments , which requires credit losses on most financial assets measured at amortized cost and certain other instruments to be measured using an expected credit loss model, referred to as the current expected credit loss (CECL) model. Under this model, entities will estimate credit losses over the entire contractual term of the instrument. The standard is effective for the Company beginning January 1, 2023. The Company does not expect the adoption of this standard to have a material impact on its consolidated financial statements. In August 2018, the FASB issued Accounting Standards Update 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement , which adds disclosure requirements to Topic 820 for the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. This standard is effective for fiscal years beginning after December 31, 2019 and early adoption is permitted. The Company is evaluating the provisions of this guidance, but currently does not expect it to have a material impact on its consolidated financial statements. |
Revenue
Revenue | 12 Months Ended |
Dec. 31, 2019 | |
REVENUE INFORMATION | |
Revenue | Note 2. Revenue On January 1, 2018, the Company adopted Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (“Topic 606”). Topic 606 supersedes the revenue recognition requirements in Topic 605 Revenue Recognition (“Topic 605”) and requires entities to recognize revenue when control of the promised goods or services is transferred to customers at an amount that reflects the consideration to which the entity expects to be entitled to in exchange for those goods or services. The Company adopted Topic 606 as of January 1, 2018 using the modified retrospective transition method applied to those contracts which were not completed as of January 1, 2018. Results for reporting periods beginning on or after January 1, 2018 are presented under Topic 606, while prior period amounts are not adjusted and continue to be reported in accordance with our historic accounting under Topic 605. Due in large part to the change in accounting estimate made by the Company in the first quarter of 2017, revenue amounts as reported for the year ended December 31, 2017 under Topic 605 are approximately the same as they would have been under Topic 606, and the Company did not have or record a cumulative impact of adopting Topic 606 as of January 1, 2018. Revenue Recognition For all revenue transactions, the Company evaluates its contracts with its customers to determine revenue recognition using the following five-step model: 1) 2) 3) 4) 5) Product Revenue Product revenue is recognized at the time of shipment at which time the Company has satisfied its performance obligation. Product revenue is recognized net of consideration paid to the Company’s customers, wholesalers and certified pharmacies. Such consideration is for services rendered by the wholesalers and pharmacies in accordance with the wholesalers and certified pharmacy services network agreements, and includes a fixed rate per prescription shipped and monthly program management and data fees. These services are not deemed sufficiently separable from the customers’ purchase of the product; therefore, they are recorded as a reduction of revenue at the time of revenue recognition. Other product revenue allowances include a reserve for estimated product returns, certain prompt pay discounts and allowances offered to the Company’s customers, program rebates and chargebacks. These product revenue allowances are recognized as a reduction of revenue at the date at which the related revenue is recognized. The Company also offers discount programs to patients. Calculating certain of these items involves estimates and judgments based on sales or invoice data, contractual terms, utilization rates, new information regarding changes in these programs’ regulations and guidelines that would impact the amount of the actual rebates or chargebacks. The Company reviews the adequacy of product revenue allowances on a quarterly basis. Amounts accrued for product revenue allowances are adjusted when trends or significant events indicate that adjustment is appropriate and to reflect actual experience. See Note 9 for product reserve balances. Change in Accounting Estimate in 2017 The Company ships units of Qsymia through a distribution network that includes certified retail pharmacies. The Company began shipping Qsymia in September 2012 and grants rights to its customers to return unsold product from six months prior to and up to 12 months subsequent to product expiration. This has resulted in a potential return period of from 24 to 36 months depending on the ship date of the product. As the Company had no previous experience in selling Qsymia and given its lengthy return period, the Company was not initially able to reliably estimate expected returns of Qsymia at the time of shipment, which was required by the accounting literature at the time, and therefore recognized revenue when units were dispensed to patients through prescriptions, at which point the product was not subject to return, or when the expiration period had ended. Beginning in the first quarter of 2017, with 48 months of returns experience, the Company believed that it had sufficient data and experience from selling Qsymia to reliably estimate expected returns. Therefore, beginning in the first quarter of 2017, under the then relevant accounting literature, the Company began recognizing revenue from the sales of Qsymia upon shipment and recording reserves for expected returns, discounts and fees at the time of shipment. In accordance with this change in accounting estimate, in the first quarter of 2017 the Company recognized a one-time adjustment relating to products that had been previously shipped, consisting of $17.9 million of gross revenues, adjusted for an expected returns reserve of $5.7 million and estimated gross-to-net charges of $4.9 million, for a net impact of $7.3 million in revenues. The Company also recorded increased cost of goods sold of $0.6 million and marketing expense of $0.7 million associated with the change in accounting estimate. The increase in net product revenue resulted in a decrease in net loss of $6.0 million or $0.57 per share for the year ended December 31, 2017. Supply Revenue The Company produces STENDRA/SPEDRA through a contract manufacturing partner and then sells it to the Company’s commercialization partners. The Company is the primary responsible party in the commercial supply arrangements and bears significant risk in the fulfillment of the obligations, including risks associated with manufacturing, regulatory compliance and quality assurance, as well as inventory, financial and credit loss. As such, the Company recognizes supply revenue on a gross basis as the principal party in the arrangements. The Company recognizes supply revenue at the time of shipment and, in the unusual case where the product does not meet contractually-specified product dating criteria at the time of shipment to the partner, the Company records a reserve for estimated product returns. There are no such reserves as of December 31, 2019. License and Milestone Revenue License and milestone revenues related to arrangements, usually license and/or supply agreements, entered into by the Company are recognized by following the five-step process outlined above. The allocation and timing of recognition of such revenue will be determined by that process and the amounts recognized and the timing of that recognition may not exactly follow the wording of the agreement as the amount allocated following the accounting analysis of the agreement may differ and the timing of recognition of a significant performance obligation may predate the contractual date. Royalty Revenue The Company relies on data provided by its collaboration partner in determining its contractually-based royalty revenue. Such data includes accounting estimates and reports for various discounts and allowances, including product returns. The Company records royalty revenues based on the best data available and makes any adjustments to such revenues as such information becomes available. Segment and Geographic Information The Company operates in one business segment — the development and commercialization of novel therapeutic products. Therefore, results of operations are reported on a consolidated basis for purposes of segment reporting, consistent with internal management reporting. Disclosures about product revenues by geographic area, revenues and accounts receivable from major customers, and major suppliers are presented below. Outside the United States, the Company sells products principally in the EU, in addition to South Korea and Canada. The geographic classification of product sales was based on the location of the customer. The geographic classification of all other revenues was based on the domicile of the entity from which the revenues were earned Revenue disaggregated by revenue source and by geographic region was as follows (in thousands): Years Ended December 31, 2019 U.S. ROW Total Qsymia—Net product revenue $ $ — $ 37,750 Qsymia—License revenue — 2,500 2,500 Qsymia—Supply revenue — 1,186 1,186 PANCREAZE - Net product revenue 20,302 997 21,299 PANCREAZE - Royalty revenue — 1,557 1,557 STENDRA/SPEDRA—Supply revenue — 3,448 3,448 STENDRA/SPEDRA—Royalty revenue — 2,020 2,020 Total revenue $ 58,052 $ 11,708 (1) $ 69,760 2018 U.S. ROW Total Qsymia—Net product revenue $ $ — $ 40,558 PANCREAZE - Net product revenue 16,226 — 16,226 PANCREAZE - Royalty revenue — 1,108 1,108 STENDRA/SPEDRA—Supply revenue 4,863 STENDRA/SPEDRA—Royalty revenue — 2,307 Total revenue $ 58,430 $ 6,632 (2) $ 65,062 2017 U.S. ROW Total Qsymia—Net product revenue $ $ — $ 44,983 Qsymia—License revenue 5,000 2,500 7,500 STENDRA/SPEDRA—Supply revenue 10,407 STENDRA/SPEDRA—Royalty revenue — 2,483 Total revenue $ 55,892 $ 9,481 (3) $ 65,373 (1) $5.5 million of which was attributable to Germany, $3.7 million of which was attributable to South Korea and $2.5 million of which was attributable to Canada. (2) $5.5 million of which was attributable to Germany and $1.1 million of which was attributable to Canada. (3) $7.0 million of which was attributable to Germany and $2.5 million of which was attributable to South Korea. Revenue and cost of goods sold by source was as follows (in thousands): Year Ended December 31, 2019 Qsymia PANCREAZE STENDRA/ SPEDRA Total Net product revenue $ 37,750 $ 21,299 $ — $ 59,049 License 2,500 — — 2,500 Supply revenue 1,186 — 3,448 4,634 Royalty revenue — 1,557 2,020 3,577 Total revenue $ 41,436 $ 22,856 $ 5,468 $ 69,760 Cost of goods sold (excluding amortization) $ 5,775 $ 6,460 $ 3,436 $ 15,671 Amortization of intangible assets $ 362 $ 14,190 $ — $ 14,552 2018 Qsymia PANCREAZE STENDRA/ SPEDRA Total Net product revenue $ 40,558 $ 16,226 $ — $ 56,784 Supply revenue — — 4,863 4,863 Royalty revenue — 1,108 2,307 3,415 Total revenue $ 40,558 $ 17,334 $ 7,170 $ 65,062 Cost of goods sold (excluding amortization) $ 4,693 $ 5,156 $ 4,764 $ 14,613 Amortization of intangible assets $ 363 8,277 $ — $ 8,640 2017 Qsymia PANCREAZE STENDRA/ SPEDRA Total Net product revenue $ 44,983 $ — $ — $ 44,983 License 7,500 — — 7,500 Supply revenue — — 10,407 10,407 Royalty revenue — — 2,483 2,483 Total revenue $ 52,483 $ — $ 12,890 $ 65,373 Cost of goods sold (excluding amortization) $ 6,993 $ — $ 9,650 $ 16,643 Amortization of intangible assets $ 544 — $ — $ 544 Major customers Revenues from significant customers as a percentage of product revenues is as follows: 2019 2018 2017 Amerisource Bergen 30 % 34 % 32 % McKesson 29 % 30 % 37 % Cardinal Health, Inc. 26 % 28 % 29 % Accounts receivable by significant customer as a percentage of the total gross accounts receivable balance are as follows: 2019 2018 Cardinal Health, Inc. 41 % 29 % Amerisource Bergen 26 % 20 % McKesson 24 % 5 % Johnson & Johnson — % 40 % Major suppliers The Company does not have any manufacturing facilities and intends to continue to rely on third parties for the supply of the starting materials, API and tablets. Catalent Pharma Solutions, LLC (“Catalent”) is the Company’s sole source of clinical and commercial supplies for Qsymia. Nordmark Arzneimittel GmbH & Co. KG (“Nordmark”) is the Company’s sole source of clinical and commercial supplies for PANCREAZE. Sanofi Chimie manufactures and supplies the API for our drug avanafil on an exclusive basis in the United States and other territories and on a semi-exclusive basis in Europe, including the EU Member States, Latin America and other territories. Sanofi Winthrop Industrie manufactures and supplies the avanafil tablets on an exclusive basis in the United States and other territories and on a semi-exclusive basis in Europe, including the EU Member States, Latin America and other territories. Third‑party manufacturers may not be able to meet the Company’s needs with respect to timing, quantity or quality. During the years ended December 31, 2019, 2018 and 2017, the Company incurred expenses for work performed by a third‑party clinical research organization that accounted for 31%, 30% and 0%, respectively, of total research and development expenses. |
Cash, Cash Equivalents, And Ava
Cash, Cash Equivalents, And Available-For-Sale Securities | 12 Months Ended |
Dec. 31, 2019 | |
CASH, CASH EQUIVALENTS, AND AVAILABLE-FOR-SALE SECURITIES | |
CASH, CASH EQUIVALENTS, AND AVAILABLE-FOR-SALE SECURITIES | Note 3. Cash, Cash Equivalents and Available‑for‑Sale Securities The fair value and the amortized cost of cash, cash equivalents, and available-for-sale securities by major security type consist of the following (in thousands): As of December 31, 2019 Gross Gross Amortized Unrealized Unrealized Estimated Cash and cash equivalents Cost Gains Losses Fair Value Cash and money market funds $ 32,649 $ — $ — $ 32,649 As of December 31, 2018 Gross Gross Amortized Unrealized Unrealized Estimated Cash and cash equivalents and available-for-sale securities Cost Gains Losses Fair Value Cash and money market funds $ 30,411 $ — $ — $ 30,411 U.S. Treasury securities 42,261 34 (111) 42,184 Corporate debt securities 38,848 9 (203) 38,654 Total 111,520 43 (314) 111,249 Less amounts classified as cash and cash equivalents (30,411) — — (30,411) Total available-for-sale securities $ 81,109 $ 43 $ (314) $ 80,838 As of December 31, 2019, the Company had no available‑for‑sale securities. As of December 31, 2018, the Company’s available for sale securities were viewed by the Company as available to support current operations and even those securities with maturities beyond 12 months were classified as current assets. Due to their short‑term maturities, the Company believes that the fair value of its bank deposits, accounts payable and accrued expenses approximate their carrying value. Fair Value Measurements Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Three levels of inputs, of which the first two are considered observable and the last unobservable, may be used to measure fair value. The three levels are: · Level 1 — Quoted prices in active markets for identical assets or liabilities. · Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. · Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The following table represents the fair value hierarchy for our cash equivalents and available-for-sale securities by major security type (in thousands): As of December 31, 2019 Level 1 Level 2 Level 3 Total Cash and money market funds $ 32,649 $ — $ — $ 32,649 As of December 31, 2018 Level 1 Level 2 Level 3 Total Cash and money market funds $ 30,411 $ — $ — $ 30,411 U.S. Treasury securities 42,184 — — 42,184 Corporate debt securities — 38,654 — 38,654 Total $ 72,595 $ 38,654 $ — $ 111,249 |
Accounts Receivable
Accounts Receivable | 12 Months Ended |
Dec. 31, 2019 | |
ACCOUNTS RECEIVABLE | |
ACCOUNTS RECEIVABLE | Note 4. Accounts Receivable Accounts receivable consist of the following (in thousands): Balance as of December 31, December 31, 2019 2018 Qsymia $ 15,423 $ 13,987 PANCREAZE 6,380 10,213 STENDRA/SPEDRA 787 1,560 22,590 25,760 Allowance for cash discounts (252) (152) Net $ 22,338 $ |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2019 | |
INVENTORIES | |
INVENTORIES | Note 5. Inventories Inventories consist of the following (in thousands): Balance as of December 31, December 31, 2019 2018 Raw materials $ 26,313 $ 17,813 Work-in-process 2,908 1,719 Finished goods 4,458 3,600 Inventories, net $ 33,679 $ 23,132 Raw materials inventories consist primarily of the API for Qsymia and STENDRA/SPEDRA. |
Prepaid Expenses And Other Curr
Prepaid Expenses And Other Current Assets | 12 Months Ended |
Dec. 31, 2019 | |
OTHER CURRENT ASSETS | |
PREPAID EXPENSES AND OTHER ASSETS | Note 6. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consist of the following (in thousands): Balance as of December 31, December 31, 2019 2018 Prepaid insurance $ 2,029 $ 1,451 Prepaid sales and marketing expenses 1,806 1,525 Taxes receivable 1,196 779 Other prepaid expenses and assets 3,103 3,783 Total $ 8,134 $ 7,538 The amounts included in prepaid expenses and other current assets consist primarily of prepayments for future services, miscellaneous non-trade receivables, prepaid interest and interest income receivable. These costs have been deferred as prepaid expenses and other current assets on the consolidated balance sheets and will be either (i) charged to expense accordingly when the related prepaid services are rendered to the Company, or (ii) converted to cash when the receivable is collected by the Company. |
Property And Equipment
Property And Equipment | 12 Months Ended |
Dec. 31, 2019 | |
Property and Equipment. | |
Property and Equipment | Note 7. Property and Equipment Property and equipment consist of the following (in thousands): Balance as of December 31, December 31, 2019 2018 Computers and software $ 2,041 $ 1,999 Furniture and fixtures 185 185 Manufacturing equipment 213 Leasehold improvements 513 513 2,952 2,910 Accumulated depreciation Property and equipment, net $ 233 $ 341 |
Intangible and Other Non-Curren
Intangible and Other Non-Current Assets | 12 Months Ended |
Dec. 31, 2019 | |
NON-CURRENT ASSETS | |
NON-CURRENT ASSETS | Note 8. Intangible and Other Non‑Current Assets Intangible and other non-current assets consist of the following (in thousands): December 31, 2019 December 31, 2018 Cost Accumulated Amortization Net Cost Accumulated Amortization Net PANCREAZE license (1) $ 141,895 $ (22,467) $ 119,428 $ 141,895 $ (8,277) $ 133,618 Janssen patents (2) 3,050 (2,959) 91 3,050 (2,597) 453 Long-term receivables (3) 413 — 413 — — — Other non-current assets (4) 208 — 208 208 — 208 Total $ 145,566 $ (25,426) $ 120,140 $ 145,153 $ (10,874) $ 134,279 (1) In June 2018, the Company acquired the rights to license PANCREAZE in the U.S. and Canada, as described further in Note 12. The rights are being amortized over their estimated useful life of 10 years using the straight-line method. (2) In September 2014, the Company acquired certain patents relating to Qsymia from Janssen Pharmaceuticals, approximately $3.1 million of which was recorded as an intangible asset. The patents are being amortized over their estimated useful life of 5.5 years using the straight-line method. (3) Long-term receivables consist of amounts not expected to be collected within a year of the balance sheet date. (4) Other non-current assets primarily consist of real estate deposits. Amortization of intangible assets was $14.6 million, $8.6 million and $0.5 million for the years ended December 31, 2019, 2018 and 2017, respectively. Future expected amortization expenses for intangible assets as of December 31, 2019 are as follows (in thousands): 2020 $ 14,280 2021 14,190 2022 14,189 2023 14,190 2024 14,189 Thereafter 48,481 Total $ 119,519 |
Accrued And Other Liabilities
Accrued And Other Liabilities | 12 Months Ended |
Dec. 31, 2019 | |
ACCRUED AND OTHER LIABILITIES | |
ACCRUED AND OTHER LIABILITIES | Note 9. Accrued and Other Liabilities Accrued and other liabilities consist of the following (in thousands): Balance as of December 31, December 31, 2019 2018 Reserve for product returns (see Note 2) $ 14,874 $ 14,878 Product-related accruals (see Note 2) 6,663 8,272 Accrued manufacturing costs 3,105 4,313 Accrued employee compensation and benefits 2,777 2,591 Accrued interest on debt (see Note 13) 1,351 — Other accrued liabilities 3,628 2,990 Total $ 32,398 $ 33,044 The amounts included in other accrued liabilities consist of obligations primarily related to sales, marketing, research, clinical development, corporate activities, the STENDRA license and royalties. |
Non-Current Accrued And Other L
Non-Current Accrued And Other Liabilities | 12 Months Ended |
Dec. 31, 2019 | |
NON-CURRENT ACCRUED AND OTHER LIABILITIES | |
NON-CURRENT ACCRUED AND OTHER LIABILITIES | Note 10. Non‑Current Accrued and Other Liabilities There were no non-current accrued and other liabilities at December 31, 2019. Non‑current accrued and other liabilities were $0.2 million at December 31, 2018, and were primarily comprised of deferred rent and costs associated with the exit of certain operating leases and security deposits relating to the sublease agreements. See Note 14. |
Deferred Revenue
Deferred Revenue | 12 Months Ended |
Dec. 31, 2019 | |
Change in Contract with Customer, Liability [Abstract] | |
Deferred Revenue from Contract with Customers | Note 11. Deferred Revenue Deferred revenue relates to a prepayment for future royalties on sales of SPEDRA. In 2019 and 2018, the Company recorded $1.2 million of revenues which had been deferred as of December 31, 2018 and 2017, respectively. These amounts were applied against the prepayment for future royalties. |
License, Commercialization And
License, Commercialization And Supply Agreements | 12 Months Ended |
Dec. 31, 2019 | |
LICENSE, COMMERCIALIZATION AND SUPPLY AGREEMENTS | |
LICENSE, COMMERCIALIZATION AND SUPPLY AGREEMENTS | Note 12. License, Commercialization and Supply Agreements MTPC In January 2001, the Company entered into an exclusive development, license and clinical trial and commercial supply agreement with Tanabe Seiyaku Co., Ltd., now Mitsubishi Tanabe Pharma Corporation (“MTPC”), for the development and commercialization of avanafil. Under the terms of the agreement, MTPC agreed to grant an exclusive license to the Company for products containing avanafil outside of Japan, North Korea, South Korea, China, Taiwan, Singapore, Indonesia, Malaysia, Thailand, Vietnam and the Philippines. The Company agreed to grant MTPC an exclusive, royalty free license within those countries for oral products that we develop containing avanafil. The MTPC agreement contains a number of milestone payments to be made by us based on various triggering events. The term of the MTPC agreement is based on a country by country and on a product by product basis. In August 2012, the Company entered into an amendment to the agreement with MTPC that permitted the Company to manufacture the API and tablets for STENDRA/SPEDRA by itself or through third parties. In 2015, the Company transferred the manufacturing of the API and tablets for STENDRA/SPEDRA to Sanofi. The Company maintains royalty obligations to MTPC which have been passed through to our commercialization partners. Menarini In July 2013, the Company entered into a license and commercialization agreement (the “Menarini License Agreement”) and a supply agreement (the “Menarini Supply Agreement”) with the Menarini Group through its subsidiary Berlin Chemie AG (“Menarini”). Under the terms of the Menarini License Agreement, Menarini received an exclusive license to commercialize and promote SPEDRA for the treatment of ED in over 40 countries, including the EU Member States, plus Australia and New Zealand. Additionally, the Company transferred to Menarini ownership of the marketing authorization for SPEDRA in the EU for the treatment of ED, which was granted by the EC in June 2013. Under the Menarini License Agreement, the Company has and is entitled to receive milestone payments based on certain net sales targets, plus royalties on SPEDRA sales. Under the terms of the Menarini Supply Agreement, the Company supplied Menarini with SPEDRA drug product until December 31, 2018. Under the Menarini Supply Agreement, Menarini also has the right to manufacture SPEDRA independently, provided that it continues to satisfy certain minimum purchase obligations to the Company. Following the expiration of the Menarini Supply Agreement, Menarini would be responsible for its own supply of SPEDRA. Either party may terminate the Menarini Supply Agreement for the other party’s uncured material breach or bankruptcy, or upon the termination of the Menarini License Agreement. In May 2019, the Company entered into Amendment No. 1 to the License and Commercialization Agreement and Commercial Supply Agreement with Menarini effective as of January 1, 2019, pursuant to which certain amendments were made to the Menarini License Agreement and the Menarini Supply Agreement, which include: (i) under the Menarini License Agreement, Menarini’s exclusive license to commercialize and promote the Company’s drug avanafil for the treatment of ED will be limited to over 40 European countries and will no longer include Australia and New Zealand; (ii) under the Menarini License Agreement, the timing requirements of the product launches by Menarini have been adjusted; (iii) under the Menarini License Agreement, the milestone payments have been adjusted to reflect the removal of Australia and New Zealand and will continue to be non-refundable and non-creditable, with one exception added for certain costs and expenses incurred by Menarini for development work related to an avanafil development opportunity in the Menarini territory (“Menarini Development”); (iv) under the Menarini License Agreement, the royalties on avanafil sales payable by Menarini to the Company will be adjusted to allow Menarini to recoup certain Menarini Development costs and expenses but only as to sales of the Menarini Development product unless the Menarini Development product is commercialized by the Company or its sublicensees outside the Menarini territory; (v) under the Menarini Supply Agreement, the minimum purchase obligations for Menarini will be modified and extended, including the ability of Menarini to satisfy its minimum purchase obligations with the purchase of avanafil API and the addition of minimum purchase obligations for the calendar years for the extended term; and (vi) under the Menarini Supply Agreement, the term will be extended to December 31, 2023, unless otherwise agreed by the parties in writing. The Company and Menarini have entered into standalone agreements relating to Australia and New Zealand, including a license with royalties and milestone payments and a supply agreement. Sanofi In July 2013, the Company entered into a Commercial Supply Agreement with Sanofi Chimie to manufacture and supply the API for avanafil on an exclusive basis in the United States and other territories and on a semi-exclusive basis in Europe, including the EU Member States, Latin America and other territories. In December 2018, the Company entered into an amendment to the Commercial Supply Agreement with Sanofi Chimie, pursuant to which certain amendments were made to the Commercial Supply Agreement, which include: (i) beginning January 1, 2019, Sanofi Chimie will manufacture and supply API for avanafil on an exclusive basis in all countries where the Company has the right to sell avanafil; (ii) beginning January 1, 2019, the yearly minimum quantities of API that the Company must purchase from Sanofi Chimie will be adjusted, as well as adjustments to the associated pricing and payment terms; and (iii) with the initial five year term of the Commercial Supply Agreement expiring on December 31, 2018, the Company and Sanofi Chimie have agreed to extend the term of the Commercial Supply Agreement until December 31, 2023 unless either party makes a timely election to terminate the agreement and that thereafter the Commercial Supply Agreement will auto-renew for successive one year terms unless either party makes a timely election not to renew. In November 2013, the Company entered into a Manufacturing and Supply Agreement with Sanofi Winthrop Industrie to manufacture and supply the avanafil tablets on an exclusive basis in the United States and other territories and on a semi exclusive basis in Europe, including the EU Member States, Latin America and other territories. The Company has minimum annual purchase commitments under these agreements for at least the initial five-year term. In May 2019, the Company entered into Amendment N°1 to the Manufacturing and Supply Agreement with Sanofi Winthrop Industrie effective as of March 18, 2019, pursuant to which certain amendments were made to the Manufacturing and Supply Agreement, which include: (i) Sanofi Winthrop Industrie will manufacture and supply the tablets for the Company’s drug avanafil on an exclusive basis in all countries where the Company or its sublicensees and/or Menarini have the right to sell avanafil; (ii) the yearly minimum quantities of tablets that the Company must purchase from Sanofi Winthrop Industrie and the price of such tablets will be adjusted; and (iii) with the initial term of the Manufacturing and Supply Agreement expiring on January 16, 2021, the Company and Sanofi Winthrop Industrie have agreed to extend the term of the Manufacturing and Supply Agreement until December 31, 2023 unless either party makes a timely election to terminate the agreement and that thereafter the Manufacturing and Supply Agreement will auto-renew for successive one year terms unless either party makes a timely election not to renew. Metuchen In September 2016, the Company entered into a license and commercialization agreement (the “Metuchen License Agreement”) and a commercial supply agreement (the “Metuchen Supply Agreement”) with Metuchen Pharmaceuticals LLC (“Metuchen”). Under the terms of the Metuchen License Agreement, Metuchen received an exclusive license to develop, commercialize and promote STENDRA in the United States, Canada, South America and India (the “Metuchen Territory”) effective October 1, 2016. The Company and Metuchen have agreed not to develop, commercialize, or in-license any other product that operates as a PDE-5 inhibitor in the Metuchen Territory for a limited time period, subject to certain exceptions. The Metuchen License Agreement will terminate upon the expiration of the last-to-expire payment obligations under the Metuchen License Agreement; upon expiration of the term of the Metuchen License Agreement, the exclusive license granted under the Metuchen License Agreement shall become fully paid-up, royalty-free, perpetual and irrevocable as to the Company but not certain trademark royalties due to MTPC. Metuchen will obtain STENDRA exclusively from the Company for a mutually agreed term pursuant to the Metuchen Supply Agreement. Metuchen may elect to transfer the control of the supply chain for STENDRA for the Metuchen Territory to itself or its designee by assigning to Metuchen the Company’s agreements with the contract manufacturer. For 2016 and each subsequent calendar year during the term of the Metuchen Supply Agreement, if Metuchen fails to purchase an agreed minimum purchase amount of STENDRA from the Company, it will reimburse the Company for the shortfall as it relates to the Company’s out of pocket costs to acquire the API needed to manufacture the agreed upon minimum purchase amount of STENDRA. Upon the termination of the Metuchen Supply Agreement (other than by Metuchen for the Company’s uncured material breach or upon completion of the transfer of the control of the supply chain), Metuchen’s agreed minimum purchase amount of STENDRA from the Company shall accelerate for the entire then current initial term or renewal term, as applicable. The initial term under the Metuchen Supply Agreement will be for a period of five years, with automatic renewal for successive two-year periods unless either party provides a termination notice to the other party at least two years in advance of the expiration of the then current term. On September 30, 2019, Metuchen provided a written notice of termination of the Metuchen Supply Agreement effective September 30, 2021. Alvogen In September 2017, the Company entered into a license and commercialization agreement (the “Alvogen License Agreement”) and a commercial supply agreement (the “Alvogen Supply Agreement”) with Alvogen Malta Operations (ROW) Ltd (“Alvogen”) which was subsequently assigned to Alvogen South Korea. Under the terms of the Alvogen License Agreement, Alvogen will be solely responsible for obtaining and maintaining regulatory approvals for all sales and marketing activities for Qsymia in South Korea. The Company received an upfront payment of $2.5 million in September 2017, which was recorded in license and milestone revenue in the third quarter of 2017, and $2.5 million in the third quarter of 2019 upon Alvogen receiving marketing authorization. The Company is eligible to receive additional payments upon commercial launch and reaching a sales milestone. Additionally, the Company will receive a royalty on Alvogen’s Qsymia net sales in South Korea. Under the Alvogen Supply Agreement, the Company will supply product to Alvogen on an exclusive basis. PANCREAZE In June 2018, the Company closed on an Asset Purchase Agreement (the “PANCREAZE Purchase Agreement”) with Janssen Pharmaceuticals, Inc. (“Janssen”) pursuant to which the Company acquired the rights to PANCREAZE and PANCREASE MT in the U.S. and Canada and certain existing inventory for a purchase price of $135.0 million in cash. The Company also acquired all of the outstanding shares of Willow Biopharma Inc. (“Willow”). Willow had no significant assets at the time of acquisition. The Company issued fully-exercisable warrants to the former owners of Willow, including John Amos, M. Scott Oehrlein and Kenneth Suh, the Company’s current Chief Executive Officer, former Chief Operations Officer and former President, respectively, for the purchase of 357,000 shares of the Company’s common stock at an exercise price of $3.70 per share and agreed to assume certain of Willow’s liabilities. The amounts paid to the former owners were accounted for as a fee for the acquisition of PANCREAZE. As all the PANCREAZE assets acquired were a part of one product line, the PANCREAZE Purchase Agreement was accounted for as an asset acquisition, with an intangible asset of $141.9 million for the PANCREAZE license recorded on the consolidated balance sheet, which was comprised of the purchase price of $135.0 million, the fair value of the warrants issued of $0.8 million, the value of liabilities assumed of $0.4 million, the value of the Willow liabilities assumed of $1.5 million and accruals for estimated destruction of future unsalable inventory of $6.3 million, less the net value of PANCREAZE inventory acquired of $2.1 million. The fair value of the warrants issued was recorded in additional paid-in capital and was estimated using the Black-Scholes option pricing model, using a term of 7.0 years, an estimated volatility of 61.6%, a risk-free interest rate of 2.91% and an expected dividend yield of 0%. The intangible asset is being amortized over an expected useful life of 10 years, which corresponds with the expiration of certain significant patent rights related to PANCREAZE. In connection with the PANCREAZE Purchase Agreement, the Company and Janssen also entered into transition services agreements pursuant to which Janssen and a Canadian affiliate of Janssen provided certain transition services to the Company in the U.S. and Canada as the Company transitioned to full control over the PANCREAZE supply chain. The Company and Johnson & Johnson Health Care Systems Inc., a New Jersey corporation and an affiliate of Janssen, also entered into a Long-Term Collaboration Agreement pursuant to which they will cooperate in the reporting and certification of pricing and sales data and the payment of rebates and discounts under certain governmental programs. These agreements terminated in the third quarter of 2019. In conjunction with the PANCREAZE Purchase Agreement, Janssen assigned to the Company the Amended and Restated Know-How License and Supply Agreement (the “Nordmark Supply Agreement”) effective as of November 7, 2017 by and between Nordmark Arzneimittel GmbH & Co. KG (“Nordmark”) and Janssen. In order to extend the term of the Nordmark Supply Agreement and ensure a stable and predictable price of the Product, the Company entered into the First Amendment to the Supply Agreement on June 26, 2019 (the “Amended Nordmark Supply Agreement”). The material terms of the Amended Nordmark Supply Agreement are: (i) the Company shall purchase certain minimum order quantities at the applicable supply prices for the calendar years under the Amended Nordmark Supply Agreement; (ii) in exchange for Nordmark’s obligations under the Amended Nordmark Supply Agreement, the Company shall pay an annual fee to Nordmark; (iii) Nordmark and the Company have agreed to undertake joint efforts to develop new formulations of PANCREAZE; (iv) the term of the Amended Nordmark Supply Agreement begins on June 26, 2019 and will continue through December 31, 2029, unless earlier terminated and may be renewed for additional five year periods unless earlier terminated; and (v) Nordmark shall have the option to terminate the Amended Nordmark Supply Agreement upon certain circumstances related to the launch date in the United States if the Company assigns any or all of its rights under the Amended Nordmark Supply Agreement to certain parties and/or enters into a transaction or series of transactions resulting in a Change of Control, as defined in the Amended Nordmark Supply Agreement. |
Long-Term Debt and Commitments
Long-Term Debt and Commitments | 12 Months Ended |
Dec. 31, 2019 | |
LONG-TERM DEBT AND COMMITMENTS | |
LONG-TERM DEBT AND COMMITMENTS | Note 13. Long‑Term Debt The Company’s indebtedness consists of the following (in thousands): Balance as of December 31, December 31, 2019 2018 Convertible senior notes due 2020 $ 181,426 $ 181,426 Unamortized discount and debt issuance costs 1,580 6,358 Convertible senior notes due 2020, net 183,006 187,784 2024 Notes 61,351 110,000 Unamortized premium and debt issuance costs, net (2,630) (3,338) 2024 Notes, net 58,721 106,662 Total debt 241,727 294,446 Less current portion 183,006 — Total long-term debt $ 58,721 $ 294,446 Convertible Senior Notes Due 2020 In May 2013, the Company closed offerings of $250.0 million in 4.5% Convertible Senior Notes due May 2020 (the “Convertible Notes”). The Convertible Notes are governed by an indenture, dated May 2013 between the Company and Deutsche Bank National Trust Company, as trustee. Total net proceeds from the Convertible Notes were approximately $241.8 million. The Convertible Notes are convertible at a conversion rate of approximately $148.58 per share at the option of the holders. Subject to certain limitations, the Company will settle conversions of the Convertible Notes by paying or delivering, as the case may be, cash, shares of its common stock or a combination of cash and shares of our common stock, at the Company’s election. Interest payments are made quarterly. In June 2018, the Company repurchased $60.0 million of face value of the Convertible Notes for $51.0 million in cash plus accrued but unpaid interest using funds received from the issuance of the Company’s Senior Secured Notes Due 2024. The gain was accounted for as a debt modification with the gain applied to the modified debt. In October 2018, the Company repurchased $8.6 million of face value of the Convertible Notes for $7.1 million in cash plus accrued but unpaid interest. The gain on this repurchase of $1.4 million was accounted for as an extinguishment of debt and recorded on the income statement. Senior Secured Notes Due 2024 In June 2018, the Company entered into an indenture (the “Indenture”) with U.S. Bank National Association as trustee and collateral agent regarding the purchase agreement entered into with affiliates of Athyrium Capital Management (collectively, the “Purchasers”) for the issuance and sale of (i) $110.0 million of 10.375% senior secured notes due 2024 (the “2024 Notes”), (ii) up to an additional $10.0 million of 10.375% senior secured notes due 2024 to be issued subsequently at the Company’s option within 12 months of the issue date of the 2024 Notes, subject to certain conditions, and (iii) a warrant for 330,000 shares issued concurrently with the issuance of the 2024 Notes. The 2024 Notes were issued at a purchase price equal to 99% of the principal amount and contain customary representations, warranties, covenants, conditions and indemnities. The Company used the net proceeds from the issuance of the 2024 Notes to pay (i) certain fees, costs and expenses relating to the issuance and sale of the 2024 Notes, (ii) to finance a portion of the acquisition of PANCREAZE and (iii) to repurchase $60.0 million of the Company’s outstanding Convertible Notes from the Purchasers or their affiliates for a purchase price of $51.0 million (plus accrued but unpaid interest to the repurchase date). The fair value of the warrant issued was estimated using the Black-Scholes option pricing model, using a term of 6.0 years, an estimated volatility of 62.7%, a risk-free interest rate of 2.83% and an expected dividend yield of 0%. The Indenture has an effective interest rate of 11.3% and includes customary covenants and events of default, including covenants that, among other things, restrict the incurrence of future indebtedness, the granting of liens, the making of investments, distributions or dividends, and the Company’s ability to merge, consolidate or sell assets, in each case subject to certain exceptions. In addition, the Indenture includes certain financial maintenance covenants related to minimum cash balances and minimum quarterly net revenues related to PANCREAZE. As of June 30, 2019, the Company was not in compliance with a covenant in the Indenture related to PANCREAZE net revenues. The Company subsequently received a waiver from the consenting noteholders with respect to any potential event of default or default that may have resulted from such covenant non-compliance. In September 2019, the Company entered into a second supplemental indenture (the “Second Supplemental Indenture”) which amended the Indenture to (i) revise the compliance dates for minimum quarterly PANCREAZE net sales, (ii) reduce the minimum unrestricted cash equivalents, and (iii) effect the pledge of material intellectual property related to Qsymia® and PANCREAZE®. The Second Supplemental Indenture was entered into in satisfaction of the conditions set forth in the waiver of default obtained in connection with the Indenture. As of December 31, 2019, the Company was in compliance with the covenants in the Indenture as modified by the Second Supplemental Indenture. In September 2019, the Company repurchased $48.6 million aggregate principal amount of the 2024 Notes plus prepayment premiums of an aggregate of $6.4 million. The prepayment premiums were recorded as interest expense. There was no gain or loss on the transaction. Future estimated payments on all of the Company’s indebtedness as of December 31, 2019 are as follows (in thousands): 2020 $ 192,327 2021 20,152 2022 23,034 2023 21,076 2024 9,822 $ 266,411 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2019 | |
Lessee Disclosure [Abstract] | |
Lease Disclosure | Note 14. Leases The Company adopted Accounting Standards Update 2016-02, Leases (Topic 842) on January 1, 2019 using the modified retrospective transition method, and as a result did not adjust comparative periods. The Company has a large operating lease for its corporate headquarters and several smaller leases, including financing leases for its automobile fleet and copiers. At the time of adoption, the Company recorded the following amounts (in thousands): Right-of-Use Asset Current Portion of Lease Liability Lease Liability, Net of Current Portion Current Portion of Deferred Rent Deferred Rent, Net of Current Portion Accumulated Deficit Operating leases $ 1,201 $ 512 $ 1,017 $ (94) $ (234) $ — Financing leases 329 131 188 — — 10 Total $ 1,530 $ 643 $ 1,205 $ (94) $ (234) $ 10 The Company’s leases have remaining lease terms ranging from less than 1 year up to 2.6 years, some of which include options to extend the leases for up to 2 years. The components of lease expense were as follows (in thousands): Year Ended December 31, 2019 Operating lease cost $ 521 Finance lease cost: Amortization of right-of-use assets $ 211 Interest on lease liabilities 11 Total finance lease cost $ 222 Supplemental balance sheet information related to leases was as follows: Balance as of December 31, 2019 Right-of-use assets: Operating leases $ 781 Financing leases 354 Total right-of-use assets $ 1,135 Current portion of lease liability: Operating leases $ 551 Financing leases 216 Total current portion of lease liability $ 767 Lease liability, net of current portion Operating leases $ 466 Financing leases 136 Total lease liability, net of current portion $ 602 The weighted average remaining lease term as of December 31, 2019 was 1.7 years for operating leases and 1.7 years for financing leases. The weighted average discount rate as of December 31, 2019 was 7.8% for operating leases and 2.9% for financing leases. Future payments of lease liabilities are as follows: Operating Leases Finance Leases 2020 $ 610 $ 224 2021 482 117 2022 - 21 Total lease payments 1,092 362 Less imputed interest (75) (10) Total $ 1,017 $ 352 |
Stockholders Equity
Stockholders Equity | 12 Months Ended |
Dec. 31, 2019 | |
Stockholders' Equity | |
Stockholders' Equity | Note 15. Stockholders’ Equity Common Stock The Company is authorized to issue 200,000,000 shares of common stock with a par value of $0.001 per share. As of December 31, 2019 and 2018, there were 10,649,000 and 10,636,000 shares, respectively, issued and outstanding. Reverse Stock Split On September 10, 2018, the Company effected a one-for-10 reverse stock split of its common stock. As a result of the reverse stock split, every 10 shares of the Company’s pre-reverse split common stock issued and outstanding was combined and converted into one issued and outstanding share of post-reverse split common stock without any change in the par value of the shares. Accordingly, an amount equal to the par value of the decreased shares resulting from the reverse stock split was reclassified from “Common stock” to “Additional paid-in capital.” No fractional shares were issued as a result of the reverse stock split; any fractional shares that would have resulted were rounded up to the nearest whole share. Proportionate voting rights and other rights of stockholders were not affected by the reverse stock split, other than as a result of the rounding up of potential fractional shares. All stock options, warrants and restricted stock units outstanding and common stock reserved for issuance under the Company’s equity incentive plans immediately prior to the reverse stock split were adjusted by dividing the number of affected shares of common stock by 10 and, where applicable, multiplying the exercise price by 10. All share and per share amounts related to common stock, stock options, warrants and restricted stock units have been restated for all periods to give retroactive effect to the reverse stock split. Preferred Stock The Company is authorized to issue 5,000,000 shares of undesignated preferred stock with a par value of $0.001 per share. As of December 31, 2019 and 2018, there were no preferred shares issued or outstanding. The Company may issue shares of preferred stock in the future, without stockholder approval, upon such terms as the Company’s management and Board of Directors may determine. Stockholder Rights Plan On December 30, 2019, the Company’s Board of Directors adopted a Preferred Stock Rights Agreement (the “New Rights Plan”) to replace the Company’s stockholder rights plan that expired in accordance with its terms on November 9, 2019. Under the New Rights Plan, the Company issued a dividend of one right for each share of its common stock held by stockholders of record as of the close of business on January 13, 2020. Each right would initially entitle the holder to purchase one one-thousandth of a share of the Company’s Series A Participating Preferred Stock for a purchase price of $12.68 (subject to adjustment). Under certain circumstances set forth in the New Rights Plan, the Company may suspend the exercisability of the rights. The New Rights Plan is designed to protect stockholder value by mitigating the likelihood of an “ownership change” that would result in significant limitations to our ability to use our net operating losses or other tax attributes to offset future income. The New Rights Plan is similar to rights plans adopted by other public companies with significant net operating loss carryforwards The New Rights Plan provides, subject to certain exceptions that if any person or group acquires 4.9% or more of the Company’s outstanding common stock, there would be a triggering event potentially resulting in significant dilution in the voting power and economic ownership of that person or group. Existing stockholders who hold 4.9% or more of the Company’s outstanding common stock as of the date of the new rights plan will trigger a dilutive event only if they acquire an additional 1% of the outstanding shares of VIVUS common stock. The New Rights Plan will continue in effect until December 30, 2022, unless earlier terminated or the rights are earlier exchanged or redeemed by the Board of Directors. The Company expects to submit the New Rights Plan to a vote at the 2020 annual meeting of stockholders. If stockholders do not approve the plan at the 2020 annual meeting, it will expire at the close of business on the following day. |
Stock Option and Purchase Plans
Stock Option and Purchase Plans | 12 Months Ended |
Dec. 31, 2019 | |
SHARE-BASED COMPENSATION | |
SHARE-BASED COMPENSATION | Note 16. Stock Option and Purchase Plans Stock Option Plans In July 2018, the Company’s Board of Directors terminated the 2010 Equity Incentive Plan (the “2010 Plan”) and adopted and approved a new 2018 Equity Incentive Plan (the “2018 Plan”) which was approved by the Company’s stockholders at the 2018 Annual Meeting of Shareholders. The 2010 Plan continues to govern awards previously granted under it and the 2001 Stock Option Plan continues to govern awards previously granted under it. The 2018 Plan provides for the grant of stock options, stock appreciation rights, restricted stock awards, restricted stock units, performance shares and performance units to individuals who perform services to the Company. The 2018 Plan will be administered by the Board of Directors, or a committee of individuals appointed by the Board of Directors, including the Compensation Committee of the Board of Directors. The maximum term of an option will be specified in the award agreement, provided that the term will be no more than 10 years, and provided further that an incentive stock option granted to a ten percent stockholder must have a term not exceeding 5 years. The 2018 Plan’s original share reserve was 150,000 shares, plus any shares reserved but not issued pursuant to awards under the 2010 Plan as of the date of stockholder approval of the 2018 Plan, or 603,375 shares, plus any shares subject to outstanding awards under the 2010 Plan and 2001 Stock Option Plan that expire or otherwise terminate without having been exercised in full, or are forfeited to or repurchased by the Company, up to a maximum of 1,881,449 shares (which was the number of shares subject to outstanding options under the 2010 Plan and 2001 Stock Option Plan as of the date of stockholder approval). In April 2018, the Company’s Board of Directors adopted the VIVUS, Inc. 2018 Inducement Equity Incentive Plan (the “Inducement Plan”) and reserved 502,000 shares of the Company’s common stock for issuance pursuant to equity awards granted under the Inducement Plan. The Inducement Plan was adopted without stockholder approval pursuant to Rule 5635(c)(4) and Rule 5635(c)(3) of the Nasdaq Listing Rules. The Inducement Plan provides for the grant of equity-based awards, including options, stock appreciation rights, restricted stock, restricted stock units, performance units and performance shares. In accordance with Rule 5635(c)(4) and Rule 5635(c)(3) of the Nasdaq Listing Rules, awards under the Inducement Plan may only be made to individuals not previously employees of the Company (or following such individuals’ bona fide period of non-employment with the Company), as an inducement material to the individuals’ entry into employment with the Company. Restricted Stock Units A summary of restricted stock unit award activity is as follows: Weighted Number of Average Restricted Grant Date Stock Units Fair Value Restricted stock units outstanding, January 1, 2017 53,843 $ Granted 45,000 Vested (62,192) Forfeited (7,518) Restricted stock units outstanding, December 31, 2017 29,133 Vested Forfeited Restricted stock units outstanding, December 31, 2018 1,045 Vested Restricted stock units outstanding, December 31, 2019 $ Stock Options A summary of stock option award activity for all plans is as follows: Years Ended December 31, 2019 2018 2017 Weighted- Weighted- Weighted- Average Average Average Number of Exercise Number of Exercise Number of Exercise Shares Price Shares Price Shares Price Options outstanding at beginning of year 2,441,062 $ 20.92 1,422,581 $ 34.12 954,724 $ 46.23 Granted 492,660 $ 4.08 1,157,668 $ 3.95 518,484 $ 10.60 Exercised — $ — (10,029) $ 6.99 — $ — Cancelled (186,479) $ 5.73 (129,158) $ 15.27 $ 21.66 Options outstanding at end of year 2,747,243 $ 18.93 2,441,062 $ 20.92 1,422,581 $ 34.12 Options exercisable at end of year 1,862,669 $ 25.70 1,124,744 $ 39.25 653,183 $ 60.72 Weighted average grant-date fair value of options granted during the year $ 2.32 $ 1.90 $ 4.95 At December 31, 2019, stock options outstanding and exercisable were as follows: Options Outstanding Options Exercisable Weighted- Number Average Weighted- Number Weighted- Outstanding at Remaining Average Exercisable Average December 31, Contractual Exercise December 31, Exercise Range of Exercise Prices 2019 Life Price 2019 Price $ 2.81 — $ 3.70 4.19 years $ $ $ 3.90 — $ 4.05 5.19 years $ 183,902 $ $ 4.07 — $ 10.60 3.34 years $ 550,556 $ $ 11.20 — $ 27.40 3.39 years $ 475,215 $ $ 27.90 — $ 257.40 1.36 years $ $ $ 2.81 — $ 257.40 3.82 years $ $ The aggregate intrinsic value of outstanding options as of December 31, 2019 was $0. At December 31, 2019, the Company had 997,075 shares available for grant. Valuation Assumptions for Options The fair value of each option is estimated on the date of grant using the Black‑Scholes option pricing model, assuming no expected dividends and the following weighted average assumptions: 2019 2018 2017 Expected life (in years) Volatility % % % Risk-free interest rate % % % Dividend yield — — — Employee Stock Purchase Plan The Company has reserved a total of 600,000 shares for issuance under the 1994 Employee Stock Purchase Plan (the “ESPP”). Under the ESPP, eligible employees may authorize payroll deductions of up to 10% of their base compensation (as defined) to purchase up to 1,000 shares per offering period of common stock at a price equal to 85% of the lower of the fair market value as of the beginning or the end of each six-month offering period. As of December 31, 2019, 201,673 shares have been issued to employees, and there are 398,327 shares available for issuance under the ESPP. The weighted average fair value of shares issued under the ESPP in 2019, 2018 and 2017 was $1.16, $1.63 and $2.28 per share, respectively. Valuation Assumptions for ESPP Shares The fair value of shares issued under the ESPP is estimated using the Black‑Scholes option pricing model, assuming no expected dividends and the following weighted average assumptions: 2019 2018 2017 Expected life (in years) Volatility % % % Risk-free interest rate % % % Dividend yield — — — Share‑Based Compensation Expense Total estimated share‑based compensation expense, related to all of the Company’s share‑based awards, was comprised as follows (in thousands): 2019 2018 2017 Cost of goods sold $ $ $ Selling and marketing General and administrative Research and development Total share-based compensation expense $ $ $ Share-based compensation expense capitalized as part of the cost of inventory $ 39 $ 26 $ 9 The following table summarizes share‑based compensation, net of estimated forfeitures associated with each type of award (in thousands): 2019 2018 2017 Restricted stock units $ — $ 249 $ 924 Stock options 2,007 3,007 2,002 Employee stock purchase plan 19 29 16 $ 2,026 $ 3,285 $ 2,942 As of December 31, 2019, unrecognized estimated compensation expense totaled $3.0 million related to non‑vested stock options and restricted stock units and $12,000 related to the ESPP. The weighted average remaining requisite service period for the non‑vested stock options was 2.3 years and for the ESPP was less than 6 months. |
Commitments
Commitments | 12 Months Ended |
Dec. 31, 2019 | |
Commitments | |
Commitments | Note 17. Commitments Lease Commitments In August 2016, the Company entered into a lease for new principal executive offices, consisting of approximately 13,981 square feet of office space at 900 E. Hamilton Avenue, Campbell, California (the “Campbell Lease”). The Campbell Lease has an initial term of approximately 58 months, commencing on December 27, 2016, with a beginning annual rental rate of $3.10 per rentable square foot, subject to agreed-upon increases. The Company received an abatement of the monthly rent for the first four months on the lease term. The Company has one option to extend the lease term for two years at the fair market rental rate then prevailing as detailed in the Campbell Lease. Beginning in August 2018, we also rent a small office space in Morristown, New Jersey with a rental period through August 2020. Future minimum lease payments under operating leases at December 31, 2019, were as follows (in thousands): 2020 $ 2021 $ Cardiovascular Outcomes Trial As a condition of FDA granting approval to commercialize Qsymia in the U.S., the Company agreed to complete certain post-marketing requirements. One requirement was to perform a cardiovascular outcomes trial (“CVOT”) on Qsymia. The cost of a CVOT is estimated to be between $180 million and $220 million incurred over a period of approximately five years. The Company is working with FDA to determine a pathway to provide FDA with information to support the safety of Qsymia in a more cost-effective manner. To date, the Company has not incurred expenses related to the CVOT. . |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
INCOME TAXES | |
INCOME TAXES | Note 18. Income Taxes The Company uses the liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on differences between financial reporting and the tax bases of assets and liabilities and are measured using enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. Deferred income taxes result from differences in the recognition of expenses for tax and financial reporting purposes, as well as operating loss and tax credit carryforwards. Significant components of the Company's deferred income tax assets as of December 31, 2019 and 2018, are as follows (in thousands): 2019 2018 Deferred tax assets: Net operating loss carry forwards $ 160,464 $ 152,172 Research and development credit carry forwards 16,859 16,721 Share-based compensation 5,113 5,086 Accruals and other 13,655 15,180 Depreciation 265 633 Deferred revenue 960 1,268 197,316 191,060 Valuation allowance (197,316) (191,060) Total $ — $ — Realization of deferred tax assets by the Company is dependent upon the generation of future taxable income, if any, the amount and timing of which are uncertain. As a result of the Company’s analysis of all available evidence, both positive and negative, as of December 31, 2019, it was considered more likely than not that the Company’s deferred tax assets would not be realized. As a result, the Company’s net deferred tax assets have been fully offset by a valuation allowance. The net increase in the valuation allowance in 2019 was $6.3 million. The net increase in the valuation allowance in 2018 was $0.2 million. As of December 31, 2019, the Company had no significant deferred tax liabilities. On December 22, 2017, the Tax Cuts and Jobs Act (the “Act”) was signed into law. Among other changes is a permanent reduction in the federal corporate income tax rate from 35% to 21% effective January 1, 2018. As a result of the reduction in the corporate income tax rate, the Company revalued its net deferred tax asset at December 31, 2017. This resulted in a reduction in the value of our net deferred tax asset of approximately $98.4 million, which was entirely offset by the change in valuation allowance of $98.4 million due to the Company’s full valuation allowance position. The Act includes certain anti-deferral and anti-base erosion provisions, including a new minimum tax on global intangible low-taxed income (“GILTI”). The Act subjects the Company to current tax on GILTI of its controlled foreign corporations. Due to current year positive tested income for the Company's foreign subsidiaries, the Company was subject to GILTI. Therefore, the Company recognized a GILTI inclusion of $0.2 million for ended December 31, 2019. There is no tax expense impact related to GILTI inclusion. As of December 31, 2019, the Company had approximately $648.5 million and $278.2 million of total federal and state net operating loss (“NOL”) carryforwards, respectively, with which to offset its future taxable income. The federal and state NOL carryforwards will begin expiring in 2028, unless previously utilized. Of the total federal NOL amount, the Company had $633.6 million of federal NOLs generated prior to tax years beginning in 2018 which may be used to offset 100% of the Company's federal taxable income (subject to the Section 382 limitation discussed below). Federal NOL carryforwards generated in tax years beginning in 2018 are not subject to expiration. Of the total federal NOL amount, the Company had $14.9 million of federal NOLs that arose in tax years beginning after 2017 which can be carried forward indefinitely against future income, but can only be used to offset a maximum of 80% of the Company’s federal taxable income in any year. The Act expanded the scope of the $1.0 million deduction limitation and expanded the definition of a covered person under US Internal Revenue Code (“IRC”) Section 162(m) for tax years beginning after December 31, 2017. The Act repealed the performance-based exception; therefore, all compensation paid to a covered employee in excess of $1.0 million will be nondeductible, unless it is subject to the transition rule. The Act expanded the definition of a covered employee to include the CFO and to cover any individual who served as the CEO or CFO at any time during the tax year. The covered employee definition has been further expanded to provide that once an employee becomes a covered employee for any tax year beginning after December 31, 2016, the employee will remain a covered employee for all future tax years. The Company had approximately $0.0 million of officer compensation expense limited for the year ended December 31, 2019. The Act revised the business interest expense limitation. For tax years beginning after December 31, 2017, IRC Section 163(j) limits the deduction for business interest to the sum of business interest income and 30 percent of adjusted taxable income without regard to business interest expense or income, and NOL deduction. Limited interest is carried forward indefinitely. In 2019, the Company’s interest limitation was $20.7 million. State conformity to this provision is applied on a jurisdiction‐by‐jurisdiction basis. The Act extended and modified IRC Section 168(k) bonus depreciation provisions, allowing businesses to immediately deduct 100% of the cost of eligible property in the year it is placed in service through 2022. The amount of allowable bonus depreciation is then phased down over four years as follows: 80% will be allowed for property placed in service in 2023, 60% in 2024, 40% in 2025, and 20% in 2026. The Company has taken bonus depreciation of approximately $0.04 million in 2019. State conformity to this provision is applied on a jurisdiction-by-jurisdiction basis. As of December 31, 2019, the Company has federal and state research credit carryforwards of approximately $12.9 million, and $5.2 million, respectively. The federal research credit carryforwards will begin expiring in 2020, unless previously utilized. The state research credit carryforwards do not expire. Utilization of the Company’s NOL and tax credit carryforwards (“Tax Attributes”) may be subject to substantial annual limitations provided by the U.S. Internal Revenue Code and similar state provisions to the extent certain ownership changes are deemed to occur. Such an annual limitation could result in the expiration of the Tax Attributes before utilization. The Tax Attributes reflected above have not been reduced by any limitations. To the extent it is determined upon completion of the analysis that such limitations do apply, the Company will adjust the Tax Attributes accordingly. The Company faces the risk that its ability to use its Tax Attributes will be substantially restricted if it undergoes an ownership change, as defined in Section 382 of the U.S. Internal Revenue Code (“Section 382”). An ownership change under Section 382 would occur if 5-percent shareholders, within the meaning of Section 382, collectively increased their ownership in the Company by more than 50 percentage points over a rolling three-year period. The Company has completed studies through December 31, 2016, and concluded that no adjustments were required. If the Company has experienced a change of control at any time since its formation, its NOL carryforwards and tax credits may not be available, or their utilization could be subject to an annual limitation under Section 382. A full valuation allowance has been provided against the Company's NOL carryforwards, and if an adjustment is required, this adjustment would be offset by an adjustment to the valuation allowance. Accordingly, there would be no impact on the consolidated financial statements. The provision (benefit) for income taxes is based upon the loss from continuing operations before income taxes as follows (in thousands): 2019 2018 2017 Income (loss) before income taxes: Domestic $ (31,643) $ (36,800) $ (30,371) International 161 (98) (138) Income (loss) before taxes $ (31,482) $ (36,898) $ (30,509) The provision (benefit) for income taxes consists of the following (in thousands): 2019 2018 2017 Current: Federal $ — $ — $ — State 21 57 2 Foreign — (5) — Total current provision (benefit) for income taxes $ 21 $ 52 $ 2 Deferred: Federal $ — $ — $ — State — — — Foreign — — — Total deferred provision for income taxes $ — $ — $ — Total provision (benefit) for income taxes from continuing operations $ 21 $ 52 $ 2 The effective tax rate differs from the amount computed by applying the statutory federal income tax rates as follows: 2019 2018 2017 Tax at U.S. federal statutory rate 21 % 21 % 35 % State income taxes, net of federal tax effect 1 2 1 Change in valuation allowance (23) (2) 310 Permanent items — (21) (24) Tax credits 1 — 1 Tax Cuts and Jobs Act impact — — (323) Effective tax rate — % — % — % The reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows (in thousands): 2019 2018 2017 Unrecognized tax benefits as of January 1 $ 91 $ 110 $ 65 Gross increase/(decrease) for tax positions of prior years 3 (33) — Gross increase/(decrease) for tax positions of current year 93 14 45 Unrecognized tax benefits balance at December 31 $ 187 $ 91 $ 110 The remaining balance of unrecognized tax benefits recorded on the Company’s consolidated balance sheets is as follows (in thousands): 2019 2018 Total unrecognized tax benefits $ 187 $ 91 Amounts netted against deferred tax assets (187) (91) Unrecognized tax benefits recorded on consolidated balance sheets $ — $ — As the Company is not currently under examination, it is reasonable to assume that the balance of gross unrecognized tax benefits will likely not change in the next twelve months. The Company currently has not recorded interest and penalties relating to uncertain tax positions. The Company files income tax returns in the United States, Canada, and the Netherlands. The federal and state income tax returns are open under the statute of limitations subject to tax examinations for the tax years ended December 31, 2015 through December 31, 2018. To the extent the Company has tax attribute carryforwards, the tax years in which the attribute was generated may still be adjusted upon examination by the IRS or state tax authorities to the extent utilized in a future period. In Canada, the Canadian Revenue Agency may reassess an income tax within three years of the original notice of assessment. For the Netherlands, the tax administration can impose an additional assessment within five years from the year in which the tax debt originated. |
401(k) Plan
401(k) Plan | 12 Months Ended |
Dec. 31, 2019 | |
Compensation and Retirement Disclosure | |
401(k) Plan | Note 19. 401(k) Plan All of the Company’s full‑time employees are eligible to participate in the VIVUS 401(k) Plan. Employer‑matching contributions for the years ended December 31, 2019, 2018 and 2017 were $256,000, $277,000 and $272,000, respectively. |
Legal Matters
Legal Matters | 12 Months Ended |
Dec. 31, 2019 | |
LEGAL MATTERS | |
LEGAL MATTERS | Note 20. Legal Matters The Company is not aware of any asserted or unasserted claims against it where it believes that an unfavorable resolution would have an adverse material impact on the operations or financial position of the Company . |
Selected Financial Data (Unaudi
Selected Financial Data (Unaudited) | 12 Months Ended |
Dec. 31, 2019 | |
Selected Financial Data (Unaudited) | |
Selected Financial Data (Unaudited) | Note 21. Selected Financial Data (Unaudited) Selected Quarterly Financial Data (in thousands except per share data): Quarter Ended, March 31 June 30 September 30 December 31 2019 Total revenue $ 16,146 $ 18,390 $ 17,970 $ 17,254 Total gross profit 11,838 14,013 14,954 13,284 Operating expenses 20,233 20,437 19,127 20,932 Net loss Basic and diluted net loss per share $ $ $ $ 2018 Total revenue $ 11,900 $ 14,960 $ 18,088 $ 20,114 Total gross profit 9,270 11,674 14,604 14,901 Operating expenses 14,192 18,312 17,680 18,357 Net loss Basic and diluted net loss per share $ $ $ $ |
Schedule II-Valuation And Quali
Schedule II-Valuation And Qualifying Accounts | 12 Months Ended |
Dec. 31, 2019 | |
SCHEDULE II-VALUATION AND QUALIFYING ACCOUNTS | |
SCHEDULE II-VALUATION AND QUALIFYING ACCOUNTS | VIVUS, Inc. SCHEDULE II—VALUATION AND QUALIFYING ACCOUNTS (in thousands) Each of the following valuation and qualifying accounts are reported as assets and liabilities of continuing and discontinued operations in the consolidated balance sheets for all periods presented. Balance at Charged Balance at Beginning of to Charges End of Period Operations* Utilized Period Allowance for Cash Discounts Fiscal year ended December 31, 2017 $ 213 $ 1,344 $ (1,362) $ 195 Fiscal year ended December 31, 2018 $ 195 $ 1,346 $ (1,389) $ 152 Fiscal year ended December 31, 2019 $ 152 $ 1,921 $ (1,821) $ 252 * |
Business And Significant Polici
Business And Significant Policies (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
BASIS OF PRESENTATION | |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements include the accounts of VIVUS, Inc., and its wholly owned subsidiaries. All significant intercompany transactions and balances have been eliminated in consolidation. |
Reverse Stock Split | Reverse Stock Split On September 10, 2018, the Company effected a one-for-10 reverse stock split of its common stock. As a result of the reverse stock split, every 10 shares of the Company’s pre-reverse split common stock issued and outstanding was combined and converted into one issued and outstanding share of post-reverse split common stock without any change in the par value of the shares. Accordingly, an amount equal to the par value of the decreased shares resulting from the reverse stock split was reclassified from “Common stock” to “Additional paid-in capital.” No fractional shares were issued as a result of the reverse stock split; any fractional shares that would have resulted were rounded up to the nearest whole share. Proportionate voting rights and other rights of stockholders were not affected by the reverse stock split, other than as a result of the rounding up of potential fractional shares. All stock options, warrants and restricted stock units outstanding and common stock reserved for issuance under the Company’s equity incentive plans immediately prior to the reverse stock split were adjusted by dividing the number of affected shares of common stock by 10 and, where applicable, multiplying the exercise price by 10. All share and per share amounts related to common stock, stock options, warrants and restricted stock units have been restated for all periods to give retroactive effect to the reverse stock split. |
Use of Estimates | Use of Estimates The Company’s consolidated financial statements are prepared in accordance with U.S. generally accepted accounting principles as set forth in the FASB’s Accounting Standards Codification, with consideration given to the various staff accounting bulletins and other applicable guidance issued by the U.S. Securities and Exchange Commission. These accounting principles require management to make certain estimates, judgments and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, the Company evaluates its estimates, including critical accounting policies or estimates related to the recognition of revenue and related reserves, available‑for‑sale securities, debt instruments, contingencies, litigation, inventories, research and development expenses, income taxes, and share‑based compensation. The Company bases its estimates on historical experience, information received from third parties and on various market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ significantly from those estimates under different assumptions or conditions. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers highly liquid investments with maturities from the date of purchase of three months or less to be cash equivalents. At December 31, 2019 and 2018, all cash equivalents were invested in money market funds or U.S. Treasury securities. These investments are recorded at fair value. See Note 3. |
Available-for-Sale Securities | Available‑for‑Sale Securities The Company determines the appropriate classification of marketable securities at the time of purchase and reevaluates such designation at each balance sheet date. Marketable securities have been classified and accounted for as available‑for‑sale. The Company may or may not hold securities with stated maturities greater than 12 months until maturity. In response to changes in the availability of and the yield on alternative investments as well as liquidity requirements, the Company may sell these securities prior to their stated maturities. As these securities are viewed by the Company as available to support current operations, securities with maturities beyond 12 months are classified as current assets. Debt securities are carried at fair value, with the unrealized gains and losses, net of taxes, reported as a component of stockholders’ equity (deficit), unless the decline in value is deemed to be other than temporary, in which case such securities are written down to fair value and the loss is charged to other‑than‑temporary loss on impaired securities. The Company periodically evaluates its investment securities for other‑than‑temporary declines based on quantitative and qualitative factors. Any losses that are deemed other-than-temporary are recognized as a non-operating loss. To date, the Company has not had any other-than-temporary declines in the value of any of the securities in its investment portfolio. Realized gains or losses on the sale of marketable securities are determined on a specific identification method, and such gains and losses are reflected as a component of interest expense. See Note 3. |
Fair Value Measurements | Fair Value Measurements The Company’s financial instruments include cash equivalents, available‑for‑sale securities, accounts receivable, accounts payable, accrued liabilities and debt. Available‑for‑sale securities are carried at fair value. The carrying value of cash equivalents, accounts receivable, accounts payable and accrued liabilities approximate their fair value due to the relatively short‑term nature of these instruments. Debt instruments are initially recorded at face value, with stated interest and amortization of debt issuance discounts and costs recognized as interest expense, which currently approximates fair value. Issuance costs related to the conversion option of the Company’s convertible notes were charged to additional paid‑in capital. The portion of the issuance costs related to the debt component is being amortized and recorded as additional interest expense over the expected life of the convertible notes. In connection with the issuance of the convertible notes, the Company entered into capped call transactions with certain counterparties affiliated with the underwriters. See Note 13. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist primarily of cash, cash equivalents, available‑for‑sale‑securities, and accounts receivable. The Company has established guidelines to limit its exposure to credit risk by placing investments in high credit quality money market funds, U.S. Treasury securities or corporate debt securities and by placing investments with maturities that maintain safety and liquidity within the Company’s liquidity needs. The Company has also established guidelines for the issuance of credit to existing and potential customers. |
Accounts Receivable, Allowances for Doubtful Accounts and Cash Discounts | Accounts Receivable, Allowances for Doubtful Accounts and Cash Discounts The Company extends credit to its customers for product sales resulting in accounts receivable. Customer accounts are monitored for past due amounts. Amounts that are determined to be uncollectible are written off against the allowance for doubtful accounts. Allowances for doubtful accounts are estimated based upon past due amounts, historical losses and existing economic factors, and are adjusted periodically. Historically, the Company has not had any significant uncollected accounts. The Company offers cash discounts to its customers, generally 2% of the sales price, as an incentive for prompt payment. The estimate of cash discounts is recorded at the time of sale. The Company accounts for the cash discounts by reducing revenue and accounts receivable by the amount of the discounts it expects the customers to take. The accounts receivable are reported in the consolidated balance sheets, net of the allowances for doubtful accounts and cash discounts. There is no allowance for doubtful accounts at December 31, 2019 or 2018. The allowance for cash discounts is $252,000 and $152,000 at December 31, 2019 and 2018, respectively. |
Inventories | Inventories Inventories are valued at the lower of cost or net realizable value. Cost is determined using the first‑in, first‑out method using a weighted average cost method calculated for each production batch. Inventory includes the cost of the active pharmaceutical ingredients (“API”), raw materials and third‑party contract manufacturing and packaging services. Indirect overhead costs associated with production and distribution are allocated to the appropriate cost pool and then absorbed into inventory based on the units produced or distributed, assuming normal capacity, in the applicable period. Inventory costs of product shipped to customers, but not yet recognized as revenue, are recorded within inventories on the consolidated balance sheets and are subsequently recognized to cost of goods sold when revenue recognition criteria have been met. The Company’s policy is to write down inventory that has become obsolete, inventory that has a cost basis in excess of its expected net realizable value and inventory in excess of expected requirements. The estimate of excess quantities is subjective and primarily dependent on the Company’s estimates of future demand for a particular product. If the estimate of future demand is inaccurate based on lower actual sales, the Company may increase the write down for excess inventory for that product and record a charge to inventory impairment. |
Property and Equipment | Property and Equipment Property and equipment is stated at cost and includes computers and software, furniture and fixtures, leasehold improvements and manufacturing equipment. Depreciation is computed using the straight‑line method over the estimated useful lives of two to seven years for computers and software, furniture and fixtures and manufacturing equipment. Leasehold improvements are amortized using the straight‑line method over the shorter of the remaining lease term or the estimated useful lives. Expenditures for repairs and maintenance, which do not extend the useful life of the property and equipment, are expensed as incurred. Gains and losses associated with dispositions are reflected as a non-operating gain or loss in the accompanying consolidated statements of operations. Long‑lived assets, including property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to an estimate of undiscounted future cash flows expected to be generated by the asset. If the carrying amount of the asset exceeds its estimated future cash flows, an impairment charge is recognized for the amount by which the carrying amount of the asset exceeds the fair value of the asset. To date, the Company has had no significant write-offs of long-lived assets. |
Debt Issuance Costs | Debt Issuance Costs Debt issuance costs, which are presented in the consolidated balance sheet as a direct deduction from the carrying amount of the debt liability, are amortized as interest expense using the effective-interest method over the expected term of the debt. |
Revenue Recognition | The Company adopted Topic 606 as of January 1, 2018 using the modified retrospective transition method applied to those contracts which were not completed as of January 1, 2018. Results for reporting periods beginning on or after January 1, 2018 are presented under Topic 606, while prior period amounts are not adjusted and continue to be reported in accordance with our historic accounting under Topic 605. Due in large part to the change in accounting estimate made by the Company in the first quarter of 2017, revenue amounts as reported for the year ended December 31, 2017 under Topic 605 are approximately the same as they would have been under Topic 606, and the Company did not have or record a cumulative impact of adopting Topic 606 as of January 1, 2018. Revenue Recognition For all revenue transactions, the Company evaluates its contracts with its customers to determine revenue recognition using the following five-step model: 1) 2) 3) 4) 5) Product Revenue Product revenue is recognized at the time of shipment at which time the Company has satisfied its performance obligation. Product revenue is recognized net of consideration paid to the Company’s customers, wholesalers and certified pharmacies. Such consideration is for services rendered by the wholesalers and pharmacies in accordance with the wholesalers and certified pharmacy services network agreements, and includes a fixed rate per prescription shipped and monthly program management and data fees. These services are not deemed sufficiently separable from the customers’ purchase of the product; therefore, they are recorded as a reduction of revenue at the time of revenue recognition. Other product revenue allowances include a reserve for estimated product returns, certain prompt pay discounts and allowances offered to the Company’s customers, program rebates and chargebacks. These product revenue allowances are recognized as a reduction of revenue at the date at which the related revenue is recognized. The Company also offers discount programs to patients. Calculating certain of these items involves estimates and judgments based on sales or invoice data, contractual terms, utilization rates, new information regarding changes in these programs’ regulations and guidelines that would impact the amount of the actual rebates or chargebacks. The Company reviews the adequacy of product revenue allowances on a quarterly basis. Amounts accrued for product revenue allowances are adjusted when trends or significant events indicate that adjustment is appropriate and to reflect actual experience. See Note 9 for product reserve balances. Change in Accounting Estimate in 2017 The Company ships units of Qsymia through a distribution network that includes certified retail pharmacies. The Company began shipping Qsymia in September 2012 and grants rights to its customers to return unsold product from six months prior to and up to 12 months subsequent to product expiration. This has resulted in a potential return period of from 24 to 36 months depending on the ship date of the product. As the Company had no previous experience in selling Qsymia and given its lengthy return period, the Company was not initially able to reliably estimate expected returns of Qsymia at the time of shipment, which was required by the accounting literature at the time, and therefore recognized revenue when units were dispensed to patients through prescriptions, at which point the product was not subject to return, or when the expiration period had ended. Beginning in the first quarter of 2017, with 48 months of returns experience, the Company believed that it had sufficient data and experience from selling Qsymia to reliably estimate expected returns. Therefore, beginning in the first quarter of 2017, under the then relevant accounting literature, the Company began recognizing revenue from the sales of Qsymia upon shipment and recording reserves for expected returns, discounts and fees at the time of shipment. In accordance with this change in accounting estimate, in the first quarter of 2017 the Company recognized a one-time adjustment relating to products that had been previously shipped, consisting of $17.9 million of gross revenues, adjusted for an expected returns reserve of $5.7 million and estimated gross-to-net charges of $4.9 million, for a net impact of $7.3 million in revenues. The Company also recorded increased cost of goods sold of $0.6 million and marketing expense of $0.7 million associated with the change in accounting estimate. The increase in net product revenue resulted in a decrease in net loss of $6.0 million or $0.57 per share for the year ended December 31, 2017. Supply Revenue The Company produces STENDRA/SPEDRA through a contract manufacturing partner and then sells it to the Company’s commercialization partners. The Company is the primary responsible party in the commercial supply arrangements and bears significant risk in the fulfillment of the obligations, including risks associated with manufacturing, regulatory compliance and quality assurance, as well as inventory, financial and credit loss. As such, the Company recognizes supply revenue on a gross basis as the principal party in the arrangements. The Company recognizes supply revenue at the time of shipment and, in the unusual case where the product does not meet contractually-specified product dating criteria at the time of shipment to the partner, the Company records a reserve for estimated product returns. There are no such reserves as of December 31, 2019. License and Milestone Revenue License and milestone revenues related to arrangements, usually license and/or supply agreements, entered into by the Company are recognized by following the five-step process outlined above. The allocation and timing of recognition of such revenue will be determined by that process and the amounts recognized and the timing of that recognition may not exactly follow the wording of the agreement as the amount allocated following the accounting analysis of the agreement may differ and the timing of recognition of a significant performance obligation may predate the contractual date. Royalty Revenue The Company relies on data provided by its collaboration partner in determining its contractually-based royalty revenue. Such data includes accounting estimates and reports for various discounts and allowances, including product returns. The Company records royalty revenues based on the best data available and makes any adjustments to such revenues as such information becomes available. |
Cost of Goods Sold | Cost of Goods Sold Cost of goods sold for units shipped to customers includes the inventory costs of API, third‑party contract manufacturing costs, packaging and distribution costs, royalties, cargo insurance, freight, shipping, handling and storage costs, and overhead costs of the employees involved with production. |
Research and Development Expenses | Research and Development Expenses Research and development (“R&D”) expenses include license fees, related compensation, consultants’ fees, facilities costs, administrative expenses related to R&D activities and clinical trial costs incurred by clinical research organizations or CROs, and research institutions under agreements that are generally cancelable, among other related R&D costs. The Company also records accruals for estimated ongoing clinical trial costs. Clinical trial costs represent costs incurred by CRO and clinical sites and include advertising for clinical trials and patient recruitment costs. These costs are recorded as a component of R&D expenses and are expensed as incurred. Under the Company’s agreements, progress payments are typically made to investigators, clinical sites and CROs. The Company analyzes the progress of the clinical trials, including levels of patient enrollment, invoices received and contracted costs when evaluating the adequacy of accrued liabilities. Significant judgments and estimates must be made and used in determining the accrued balance in any accounting period. Actual results could differ from those estimates under different assumptions. Revisions are charged to expense in the period in which the facts that give rise to the revision become known. In addition, the Company has obtained rights to patented intellectual properties under several licensing agreements for use in research and development activities. Non‑refundable licensing payments made for intellectual properties that have no alternative future uses are expensed to research and development as incurred. |
Advertising Expenses | Advertising Expenses Advertising expenses are expensed as incurred. The Company incurred advertising and sales promotion costs of $1.9 million, $2.1 million and $3.2 million in 2019, 2018 and 2017, respectively. |
Share-based compensation | Share‑Based Compensation Compensation expense is recognized for share-based payments, including stock options, restricted stock units and shares issued under the employee stock purchase plan, using a fair‑value based method. The Company estimates the fair value of share‑based payment awards on the date of the grant using the Black‑Scholes option‑pricing model, which requires the Company to estimate the expected term of the award, the expected volatility, the risk-free interest rate and the expected dividends. The expected term, which represents the period of time that options granted are expected to be outstanding, is derived by analyzing the historical experience of similar awards, giving consideration to the contractual terms of the share‑based awards, vesting schedules and expectations of future employee behavior. Expected volatilities are estimated using the historical share price performance over the expected term of the option, which are adjusted as necessary for any other factors which may reasonably affect the volatility of VIVUS’s stock in the future. The risk‑free interest rate is based on the U.S. Treasury yield in effect at the time of the grant for the expected term of the award. The Company does not anticipate paying any dividends in the near future. The Company develops pre‑vesting forfeiture assumptions based on an analysis of historical data and expected future activity. |
Income Taxes | Income Taxes The Company makes certain estimates and judgments in determining income tax expense for financial statement purposes. These estimates and judgments occur in the calculation of certain tax assets and liabilities, which arise from differences in the timing of recognition of revenue and expense for tax and financial statement purposes. As part of the process of preparing the Company’s consolidated financial statements, the Company is required to estimate its income taxes in each of the jurisdictions in which the Company operates. This process involves the Company estimating its current tax exposure under the most recent tax laws and assessing temporary differences resulting from differing treatment of items for tax and accounting purposes. These differences result in deferred tax assets and liabilities, which are included in the Company’s consolidated balance sheets. The Company assesses the likelihood that it will be able to recover its deferred tax assets by considering all available evidence, both positive and negative, including historical levels of income, expectations and risks associated with estimates of future taxable income and ongoing prudent and feasible tax planning strategies in assessing the need for a valuation allowance. If it is not more likely than not that the Company will recover its deferred tax assets, the Company will increase its provision for taxes by recording a valuation allowance against the deferred tax assets that the Company estimates will not ultimately be recoverable. Realization of deferred tax assets by the Company is dependent upon the amount and timing of the generation of future taxable income, if any. As a result of the Company’s analysis of all available evidence, both positive and negative, as of December 31, 2019, it was considered more likely than not that the Company’s deferred tax assets would not be realized. As a result, the Company’s net deferred tax assets have been fully offset by a valuation allowance. Should there be a change in the Company’s ability to recover its deferred tax assets, the Company would recognize a benefit to its tax provision in the period in which the Company determines that it is more likely than not that it will recover its deferred tax assets. The Company will continue to analyze the evidence each quarter during 2020 to determine whether it becomes more likely than not that all or a portion of its deferred tax assets are realizable. The Company recognizes interest and penalties accrued on any unrecognized tax benefits as a component of its provision for income taxes. See Note 18. |
Foreign Currency Transactions | Foreign Currency Transactions Transactions in foreign currencies are initially recorded at the rates of exchange prevailing on the dates of the transactions. Monetary assets and liabilities denominated in foreign currencies are retranslated into the Company’s functional currency at the rates prevailing on the balance sheet date. Non‑monetary items carried at fair value that are denominated in foreign currencies are retranslated at the rates prevailing on the initial transaction dates. Exchange differences arising on the settlement of monetary items, and on the retranslation of monetary items, are included in the profit and loss account for the period. Exchange differences arising on the retranslation of non‑monetary items carried at fair value are included in other expense in the accompanying consolidated statements of operations for the period. |
Contingencies and Litigation | Contingencies and Litigation The Company is periodically involved in disputes and litigation related to a variety of matters. When it is probable that the Company will experience a loss, and that loss is quantifiable, the Company records appropriate reserves. The Company records legal fees and costs as an expense when incurred. |
Intangible Assets | Intangible Assets The Company records acquired intangible assets at cost and amortizes them over the estimated useful life of the asset. When events or changes in circumstances indicate that the carrying value of intangible assets may not be recoverable, the Company evaluates such impairment if the net book value of such assets exceeds the future undiscounted cash flows attributable to such assets. Should an impairment exist, the impairment loss would be measured based on the excess carrying value of the asset over the asset’s fair value or discounted estimates of future cash flows attributable to the assets. To date, the Company has recorded no impairment losses on its intangible assets. See Note 8. |
Net Loss Per Share | Net Loss Per Share The Company computes basic net loss per share applicable to common stockholders based on the weighted average number of common shares outstanding during the period. Diluted net loss per share is based on the weighted average number of common and common equivalent shares, which represent shares that may be issued in the future upon the exercise of outstanding stock options or upon a net share settlement of the Company’s Convertible Notes. Common share equivalents are excluded from the computation in periods in which they have an anti‑dilutive effect. Stock options for which the price exceeds the average market price over the period have an anti‑dilutive effect on net loss per share and, accordingly, are excluded from the calculation. As discussed in Note 13, the triggering conversion conditions that allow holders of the Convertible Notes to convert have not been met. If such conditions are met and the note holders opt to convert, the Company may choose to pay in cash, common stock, or a combination thereof. However, if this occurs, the Company has the intent and ability to net share settle this debt security; thus the Company uses the treasury stock method for net loss per share purposes. Due to the effect of the capped call instrument purchased in relation to the Convertible Notes, there would be no net shares issued until the market value of the Company’s stock exceeds $20 per share, and thus no impact on diluted net loss per share. Further, when there is a net loss, other potentially dilutive common equivalent shares are not included in the calculation of net loss per share since their inclusion would be anti‑dilutive. The following table presents the computation of basic and diluted net loss per share (in thousands, except per share amounts): 2019 2018 2017 Net loss $ $ $ Basic and Diluted: Weighted-average shares outstanding Basic and diluted net loss per share $ $ $ For the years ended December 31, 2019, 2018, and 2017, potentially dilutive outstanding stock options and RSUs of 2,847,000, 2,168,000 and 1,350,000, respectively, were not included in the computation of diluted net loss per share because the effect would have been anti‑dilutive. |
New Accounting Pronouncements, Policy | Recent Accounting Pronouncement Adopted In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update 2016-02, Leases (Topic 842), which modifies the accounting by lessees for all leases with a term greater than 12 months. This standard requires lessees to recognize on the balance sheet the assets and liabilities for the rights and obligations created by those leases. The Company adopted this standard on January 1, 2019 using the modified retrospective transition method, and as a result did not adjust comparative periods. The Company has one large operating lease for its corporate headquarters and several smaller leases, including financing leases for its automobile fleet and copiers. See Note 14. Recent Accounting Pronouncements Not Yet Adopted In June 2016, the FASB issued Accounting Standards Update 2016-13, Measurement of Credit Losses on Financial Instruments , which requires credit losses on most financial assets measured at amortized cost and certain other instruments to be measured using an expected credit loss model, referred to as the current expected credit loss (CECL) model. Under this model, entities will estimate credit losses over the entire contractual term of the instrument. The standard is effective for the Company beginning January 1, 2023. The Company does not expect the adoption of this standard to have a material impact on its consolidated financial statements. In August 2018, the FASB issued Accounting Standards Update 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement , which adds disclosure requirements to Topic 820 for the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. This standard is effective for fiscal years beginning after December 31, 2019 and early adoption is permitted. The Company is evaluating the provisions of this guidance, but currently does not expect it to have a material impact on its consolidated financial statements. |
Business and Significant Acco_2
Business and Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Earnings Per Share, Basic and Diluted | The following table presents the computation of basic and diluted net loss per share (in thousands, except per share amounts): 2019 2018 2017 Net loss $ $ $ Basic and Diluted: Weighted-average shares outstanding Basic and diluted net loss per share $ $ $ |
Revenue (Segment Information an
Revenue (Segment Information and Concentration of Customers and Suppliers) (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Concentration of Customers | |
Schedule of net product revenue by geographic region | Revenue disaggregated by revenue source and by geographic region was as follows (in thousands): Years Ended December 31, 2019 U.S. ROW Total Qsymia—Net product revenue $ $ — $ 37,750 Qsymia—License revenue — 2,500 2,500 Qsymia—Supply revenue — 1,186 1,186 PANCREAZE - Net product revenue 20,302 997 21,299 PANCREAZE - Royalty revenue — 1,557 1,557 STENDRA/SPEDRA—Supply revenue — 3,448 3,448 STENDRA/SPEDRA—Royalty revenue — 2,020 2,020 Total revenue $ 58,052 $ 11,708 (1) $ 69,760 2018 U.S. ROW Total Qsymia—Net product revenue $ $ — $ 40,558 PANCREAZE - Net product revenue 16,226 — 16,226 PANCREAZE - Royalty revenue — 1,108 1,108 STENDRA/SPEDRA—Supply revenue 4,863 STENDRA/SPEDRA—Royalty revenue — 2,307 Total revenue $ 58,430 $ 6,632 (2) $ 65,062 2017 U.S. ROW Total Qsymia—Net product revenue $ $ — $ 44,983 Qsymia—License revenue 5,000 2,500 7,500 STENDRA/SPEDRA—Supply revenue 10,407 STENDRA/SPEDRA—Royalty revenue — 2,483 Total revenue $ 55,892 $ 9,481 (3) $ 65,373 (1) $5.5 million of which was attributable to Germany, $3.7 million of which was attributable to South Korea and $2.5 million of which was attributable to Canada. (2) $5.5 million of which was attributable to Germany and $1.1 million of which was attributable to Canada. (3) $7.0 million of which was attributable to Germany and $2.5 million of which was attributable to South Korea. |
Schedule of Revenue And Cost Of Goods Sold By Source | Revenue and cost of goods sold by source was as follows (in thousands): Year Ended December 31, 2019 Qsymia PANCREAZE STENDRA/ SPEDRA Total Net product revenue $ 37,750 $ 21,299 $ — $ 59,049 License 2,500 — — 2,500 Supply revenue 1,186 — 3,448 4,634 Royalty revenue — 1,557 2,020 3,577 Total revenue $ 41,436 $ 22,856 $ 5,468 $ 69,760 Cost of goods sold (excluding amortization) $ 5,775 $ 6,460 $ 3,436 $ 15,671 Amortization of intangible assets $ 362 $ 14,190 $ — $ 14,552 2018 Qsymia PANCREAZE STENDRA/ SPEDRA Total Net product revenue $ 40,558 $ 16,226 $ — $ 56,784 Supply revenue — — 4,863 4,863 Royalty revenue — 1,108 2,307 3,415 Total revenue $ 40,558 $ 17,334 $ 7,170 $ 65,062 Cost of goods sold (excluding amortization) $ 4,693 $ 5,156 $ 4,764 $ 14,613 Amortization of intangible assets $ 363 8,277 $ — $ 8,640 2017 Qsymia PANCREAZE STENDRA/ SPEDRA Total Net product revenue $ 44,983 $ — $ — $ 44,983 License 7,500 — — 7,500 Supply revenue — — 10,407 10,407 Royalty revenue — — 2,483 2,483 Total revenue $ 52,483 $ — $ 12,890 $ 65,373 Cost of goods sold (excluding amortization) $ 6,993 $ — $ 9,650 $ 16,643 Amortization of intangible assets $ 544 — $ — $ 544 |
Total revenues | |
Concentration of Customers | |
Schedule of significant customers concentration | Revenues from significant customers as a percentage of product revenues is as follows: 2019 2018 2017 Amerisource Bergen 30 % 34 % 32 % McKesson 29 % 30 % 37 % Cardinal Health, Inc. 26 % 28 % 29 % |
Gross accounts receivable | Customer concentration | |
Concentration of Customers | |
Schedule of significant customers concentration | Accounts receivable by significant customer as a percentage of the total gross accounts receivable balance are as follows: 2019 2018 Cardinal Health, Inc. 41 % 29 % Amerisource Bergen 26 % 20 % McKesson 24 % 5 % Johnson & Johnson — % 40 % |
Cash, Cash Equivalents, And A_2
Cash, Cash Equivalents, And Available-For-Sale Securities (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
CASH, CASH EQUIVALENTS, AND AVAILABLE-FOR-SALE SECURITIES | |
Schedule of fair value and amortized cost of cash, cash equivalents, and available-for-sale securities by major security type | The fair value and the amortized cost of cash, cash equivalents, and available-for-sale securities by major security type consist of the following (in thousands): As of December 31, 2019 Gross Gross Amortized Unrealized Unrealized Estimated Cash and cash equivalents Cost Gains Losses Fair Value Cash and money market funds $ 32,649 $ — $ — $ 32,649 As of December 31, 2018 Gross Gross Amortized Unrealized Unrealized Estimated Cash and cash equivalents and available-for-sale securities Cost Gains Losses Fair Value Cash and money market funds $ 30,411 $ — $ — $ 30,411 U.S. Treasury securities 42,261 34 (111) 42,184 Corporate debt securities 38,848 9 (203) 38,654 Total 111,520 43 (314) 111,249 Less amounts classified as cash and cash equivalents (30,411) — — (30,411) Total available-for-sale securities $ 81,109 $ 43 $ (314) $ 80,838 |
Schedule of Fair Value of Separate Accounts by Major Category of Investment | The following table represents the fair value hierarchy for our cash equivalents and available-for-sale securities by major security type (in thousands): As of December 31, 2019 Level 1 Level 2 Level 3 Total Cash and money market funds $ 32,649 $ — $ — $ 32,649 As of December 31, 2018 Level 1 Level 2 Level 3 Total Cash and money market funds $ 30,411 $ — $ — $ 30,411 U.S. Treasury securities 42,184 — — 42,184 Corporate debt securities — 38,654 — 38,654 Total $ 72,595 $ 38,654 $ — $ 111,249 |
Accounts Receivable (Tables)
Accounts Receivable (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
ACCOUNTS RECEIVABLE | |
Schedule of accounts receivable | Accounts receivable consist of the following (in thousands): Balance as of December 31, December 31, 2019 2018 Qsymia $ 15,423 $ 13,987 PANCREAZE 6,380 10,213 STENDRA/SPEDRA 787 1,560 22,590 25,760 Allowance for cash discounts (252) (152) Net $ 22,338 $ |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
INVENTORIES | |
Schedule of inventories | Inventories consist of the following (in thousands): Balance as of December 31, December 31, 2019 2018 Raw materials $ 26,313 $ 17,813 Work-in-process 2,908 1,719 Finished goods 4,458 3,600 Inventories, net $ 33,679 $ 23,132 |
Prepaid Expenses And Other Cu_2
Prepaid Expenses And Other Current Assets (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
OTHER CURRENT ASSETS | |
Schedule of prepaid expenses and other assets | Prepaid expenses and other current assets consist of the following (in thousands): Balance as of December 31, December 31, 2019 2018 Prepaid insurance $ 2,029 $ 1,451 Prepaid sales and marketing expenses 1,806 1,525 Taxes receivable 1,196 779 Other prepaid expenses and assets 3,103 3,783 Total $ 8,134 $ 7,538 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property and Equipment. | |
Schedule of property and equipment | Property and equipment consist of the following (in thousands): Balance as of December 31, December 31, 2019 2018 Computers and software $ 2,041 $ 1,999 Furniture and fixtures 185 185 Manufacturing equipment 213 Leasehold improvements 513 513 2,952 2,910 Accumulated depreciation Property and equipment, net $ 233 $ 341 |
Intangible and Other Noncurrent
Intangible and Other Noncurrent Assets (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
NON-CURRENT ASSETS | |
Schedule of Finite-Lived Intangible Assets And Other Noncurrent Assets | Intangible and other non-current assets consist of the following (in thousands): December 31, 2019 December 31, 2018 Cost Accumulated Amortization Net Cost Accumulated Amortization Net PANCREAZE license (1) $ 141,895 $ (22,467) $ 119,428 $ 141,895 $ (8,277) $ 133,618 Janssen patents (2) 3,050 (2,959) 91 3,050 (2,597) 453 Long-term receivables (3) 413 — 413 — — — Other non-current assets (4) 208 — 208 208 — 208 Total $ 145,566 $ (25,426) $ 120,140 $ 145,153 $ (10,874) $ 134,279 (1) In June 2018, the Company acquired the rights to license PANCREAZE in the U.S. and Canada, as described further in Note 12. The rights are being amortized over their estimated useful life of 10 years using the straight-line method. (2) In September 2014, the Company acquired certain patents relating to Qsymia from Janssen Pharmaceuticals, approximately $3.1 million of which was recorded as an intangible asset. The patents are being amortized over their estimated useful life of 5.5 years using the straight-line method. (3) Long-term receivables consist of amounts not expected to be collected within a year of the balance sheet date. (4) Other non-current assets primarily consist of real estate deposits. |
Future Expected Amortization Expenses For Intangible Assets | Future expected amortization expenses for intangible assets as of December 31, 2019 are as follows (in thousands): 2020 $ 14,280 2021 14,190 2022 14,189 2023 14,190 2024 14,189 Thereafter 48,481 Total $ 119,519 |
Accrued And Other Liabilities (
Accrued And Other Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
ACCRUED AND OTHER LIABILITIES | |
Schedule of accrued and other liabilities | Accrued and other liabilities consist of the following (in thousands): Balance as of December 31, December 31, 2019 2018 Reserve for product returns (see Note 2) $ 14,874 $ 14,878 Product-related accruals (see Note 2) 6,663 8,272 Accrued manufacturing costs 3,105 4,313 Accrued employee compensation and benefits 2,777 2,591 Accrued interest on debt (see Note 13) 1,351 — Other accrued liabilities 3,628 2,990 Total $ 32,398 $ 33,044 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
LONG-TERM DEBT AND COMMITMENTS | |
Schedule of debt | The Company’s indebtedness consists of the following (in thousands): Balance as of December 31, December 31, 2019 2018 Convertible senior notes due 2020 $ 181,426 $ 181,426 Unamortized discount and debt issuance costs 1,580 6,358 Convertible senior notes due 2020, net 183,006 187,784 2024 Notes 61,351 110,000 Unamortized premium and debt issuance costs, net (2,630) (3,338) 2024 Notes, net 58,721 106,662 Total debt 241,727 294,446 Less current portion 183,006 — Total long-term debt $ 58,721 $ 294,446 |
Schedule of Maturities of Long-term Debt | Future estimated payments on all of the Company’s indebtedness as of December 31, 2019 are as follows (in thousands): 2020 $ 192,327 2021 20,152 2022 23,034 2023 21,076 2024 9,822 $ 266,411 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Components of Lease Cost | The components of lease expense were as follows (in thousands): Year Ended December 31, 2019 Operating lease cost $ 521 Finance lease cost: Amortization of right-of-use assets $ 211 Interest on lease liabilities 11 Total finance lease cost $ 222 Supplemental balance sheet information related to leases was as follows: Balance as of December 31, 2019 Right-of-use assets: Operating leases $ 781 Financing leases 354 Total right-of-use assets $ 1,135 Current portion of lease liability: Operating leases $ 551 Financing leases 216 Total current portion of lease liability $ 767 Lease liability, net of current portion Operating leases $ 466 Financing leases 136 Total lease liability, net of current portion $ 602 |
Lessee, Operating Leases And Finance Leases Liabilities Maturities | Future payments of lease liabilities are as follows: Operating Leases Finance Leases 2020 $ 610 $ 224 2021 482 117 2022 - 21 Total lease payments 1,092 362 Less imputed interest (75) (10) Total $ 1,017 $ 352 |
Accounting Standards Update 2016-02 [Member] | |
Schedule of New Accounting Pronouncements and Changes in Accounting Principles | At the time of adoption, the Company recorded the following amounts (in thousands): Right-of-Use Asset Current Portion of Lease Liability Lease Liability, Net of Current Portion Current Portion of Deferred Rent Deferred Rent, Net of Current Portion Accumulated Deficit Operating leases $ 1,201 $ 512 $ 1,017 $ (94) $ (234) $ — Financing leases 329 131 188 — — 10 Total $ 1,530 $ 643 $ 1,205 $ (94) $ (234) $ 10 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Summary of restricted stock unit award activity | A summary of restricted stock unit award activity is as follows: Weighted Number of Average Restricted Grant Date Stock Units Fair Value Restricted stock units outstanding, January 1, 2017 53,843 $ Granted 45,000 Vested (62,192) Forfeited (7,518) Restricted stock units outstanding, December 31, 2017 29,133 Vested Forfeited Restricted stock units outstanding, December 31, 2018 1,045 Vested Restricted stock units outstanding, December 31, 2019 $ |
Summary of stock option award activity | A summary of stock option award activity for all plans is as follows: Years Ended December 31, 2019 2018 2017 Weighted- Weighted- Weighted- Average Average Average Number of Exercise Number of Exercise Number of Exercise Shares Price Shares Price Shares Price Options outstanding at beginning of year 2,441,062 $ 20.92 1,422,581 $ 34.12 954,724 $ 46.23 Granted 492,660 $ 4.08 1,157,668 $ 3.95 518,484 $ 10.60 Exercised — $ — (10,029) $ 6.99 — $ — Cancelled (186,479) $ 5.73 (129,158) $ 15.27 $ 21.66 Options outstanding at end of year 2,747,243 $ 18.93 2,441,062 $ 20.92 1,422,581 $ 34.12 Options exercisable at end of year 1,862,669 $ 25.70 1,124,744 $ 39.25 653,183 $ 60.72 Weighted average grant-date fair value of options granted during the year $ 2.32 $ 1.90 $ 4.95 |
Schedule of stock options outstanding and exercisable, by range of exercise prices | At December 31, 2019, stock options outstanding and exercisable were as follows: Options Outstanding Options Exercisable Weighted- Number Average Weighted- Number Weighted- Outstanding at Remaining Average Exercisable Average December 31, Contractual Exercise December 31, Exercise Range of Exercise Prices 2019 Life Price 2019 Price $ 2.81 — $ 3.70 4.19 years $ $ $ 3.90 — $ 4.05 5.19 years $ 183,902 $ $ 4.07 — $ 10.60 3.34 years $ 550,556 $ $ 11.20 — $ 27.40 3.39 years $ 475,215 $ $ 27.90 — $ 257.40 1.36 years $ $ $ 2.81 — $ 257.40 3.82 years $ $ |
Schedule of share-based compensation expense | Total estimated share‑based compensation expense, related to all of the Company’s share‑based awards, was comprised as follows (in thousands): 2019 2018 2017 Cost of goods sold $ $ $ Selling and marketing General and administrative Research and development Total share-based compensation expense $ $ $ Share-based compensation expense capitalized as part of the cost of inventory $ 39 $ 26 $ 9 |
Schedule of share-based compensation, net of estimated forfeitures associated with each type of award | The following table summarizes share‑based compensation, net of estimated forfeitures associated with each type of award (in thousands): 2019 2018 2017 Restricted stock units $ — $ 249 $ 924 Stock options 2,007 3,007 2,002 Employee stock purchase plan 19 29 16 $ 2,026 $ 3,285 $ 2,942 |
Stock options awards | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of weighted average assumptions used in estimating the fair value of stock options | The fair value of each option is estimated on the date of grant using the Black‑Scholes option pricing model, assuming no expected dividends and the following weighted average assumptions: 2019 2018 2017 Expected life (in years) Volatility % % % Risk-free interest rate % % % Dividend yield — — — |
Employee Stock Purchase Plan | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of weighted average assumptions used in estimating the fair value of stock options | The fair value of shares issued under the ESPP is estimated using the Black‑Scholes option pricing model, assuming no expected dividends and the following weighted average assumptions: 2019 2018 2017 Expected life (in years) Volatility % % % Risk-free interest rate % % % Dividend yield — — — |
Commitments (Tables)
Commitments (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Commitments | |
Future minimum lease payments under operating leases schedule | Future minimum lease payments under operating leases at December 31, 2019, were as follows (in thousands): 2020 $ 2021 $ |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
INCOME TAXES | |
Schedule of significant components of deferred income tax assets | Significant components of the Company's deferred income tax assets as of December 31, 2019 and 2018, are as follows (in thousands): 2019 2018 Deferred tax assets: Net operating loss carry forwards $ 160,464 $ 152,172 Research and development credit carry forwards 16,859 16,721 Share-based compensation 5,113 5,086 Accruals and other 13,655 15,180 Depreciation 265 633 Deferred revenue 960 1,268 197,316 191,060 Valuation allowance (197,316) (191,060) Total $ — $ — |
Schedule of (loss)/income from continuing operations before (benefit)/provision for income taxes | The provision (benefit) for income taxes is based upon the loss from continuing operations before income taxes as follows (in thousands): 2019 2018 2017 Income (loss) before income taxes: Domestic $ (31,643) $ (36,800) $ (30,371) International 161 (98) (138) Income (loss) before taxes $ (31,482) $ (36,898) $ (30,509) |
Schedule of components of (benefit)/provision for income taxes | The provision (benefit) for income taxes consists of the following (in thousands): 2019 2018 2017 Current: Federal $ — $ — $ — State 21 57 2 Foreign — (5) — Total current provision (benefit) for income taxes $ 21 $ 52 $ 2 Deferred: Federal $ — $ — $ — State — — — Foreign — — — Total deferred provision for income taxes $ — $ — $ — Total provision (benefit) for income taxes from continuing operations $ 21 $ 52 $ 2 |
Schedule of reconciliation between the U.S. federal statutory tax rate and effective tax rate from continuing operations | 2019 2018 2017 Tax at U.S. federal statutory rate 21 % 21 % 35 % State income taxes, net of federal tax effect 1 2 1 Change in valuation allowance (23) (2) 310 Permanent items — (21) (24) Tax credits 1 — 1 Tax Cuts and Jobs Act impact — — (323) Effective tax rate — % — % — % |
Schedule of reconciliation of unrecognized tax benefits | The reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows (in thousands): 2019 2018 2017 Unrecognized tax benefits as of January 1 $ 91 $ 110 $ 65 Gross increase/(decrease) for tax positions of prior years 3 (33) — Gross increase/(decrease) for tax positions of current year 93 14 45 Unrecognized tax benefits balance at December 31 $ 187 $ 91 $ 110 |
Schedule of unrecognized tax benefits recorded on consolidated balance sheets | The remaining balance of unrecognized tax benefits recorded on the Company’s consolidated balance sheets is as follows (in thousands): 2019 2018 Total unrecognized tax benefits $ 187 $ 91 Amounts netted against deferred tax assets (187) (91) Unrecognized tax benefits recorded on consolidated balance sheets $ — $ — |
Selected Financial Information
Selected Financial Information (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Selected Financial Data (Unaudited) | |
Schedule of selected quarterly financial data | Selected Quarterly Financial Data (in thousands except per share data): Quarter Ended, March 31 June 30 September 30 December 31 2019 Total revenue $ 16,146 $ 18,390 $ 17,970 $ 17,254 Total gross profit 11,838 14,013 14,954 13,284 Operating expenses 20,233 20,437 19,127 20,932 Net loss Basic and diluted net loss per share $ $ $ $ 2018 Total revenue $ 11,900 $ 14,960 $ 18,088 $ 20,114 Total gross profit 9,270 11,674 14,604 14,901 Operating expenses 14,192 18,312 17,680 18,357 Net loss Basic and diluted net loss per share $ $ $ $ |
Business And Significant Acco_3
Business And Significant Accounting Policies, Narratives (Details) $ in Thousands | Sep. 10, 2018shares | Dec. 31, 2019USD ($)itemshares | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Number of Approved Federal Drug Administration Therapies | item | 3 | |||
Number of product candidate in active clinical development | item | 1 | |||
Retained Earnings (Accumulated Deficit) | $ (912,008) | $ (880,515) | ||
Cash and Cash Equivalents, at Carrying Value | 32,649 | 30,411 | ||
Long-term Debt | $ 241,727 | 294,446 | ||
Percentage of Cash Discount | 2.00% | |||
Advertising and sales promotion expenses incurred | $ 1,900 | 2,100 | $ 3,200 | |
Impairment of Intangible Assets, Finite-lived | 0 | |||
Allowance for credit loss | ||||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Allowance for Doubtful Accounts | 252 | 152 | ||
Allowance for cash discounts member | ||||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Accounts receivable and allowance for doubtful accounts | 0 | 0 | ||
Convertible Senior Notes Due 2020 | ||||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Long-term Debt | 183,006 | 187,784 | ||
Long-term Debt, Fair Value | $ 181,426 | $ 181,426 | ||
Reverse Stock Split Member | ||||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||||
Conversion of Stock, Shares Converted | shares | 10 | |||
Conversion of Stock, Shares Issued | shares | 1 | 1 | ||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 10 | 10 |
Business and Significant Acco_4
Business and Significant Accounting Policies, PP&E (Details) | 12 Months Ended |
Dec. 31, 2019 | |
Computers and software | Minimum | |
Property and equipment | |
Estimated useful lives for computers, software, furniture and fixtures, manufacturing equipment | 2 years |
Computers and software | Maximum | |
Property and equipment | |
Estimated useful lives for computers, software, furniture and fixtures, manufacturing equipment | 7 years |
Furniture and fixtures | Minimum | |
Property and equipment | |
Estimated useful lives for computers, software, furniture and fixtures, manufacturing equipment | 2 years |
Furniture and fixtures | Maximum | |
Property and equipment | |
Estimated useful lives for computers, software, furniture and fixtures, manufacturing equipment | 7 years |
Manufacturing equipment | Minimum | |
Property and equipment | |
Estimated useful lives for computers, software, furniture and fixtures, manufacturing equipment | 2 years |
Manufacturing equipment | Maximum | |
Property and equipment | |
Estimated useful lives for computers, software, furniture and fixtures, manufacturing equipment | 7 years |
Business and Significant Acco_5
Business and Significant Accounting Policies (Net Income Loss per Share) (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Anti-dilutive Securities | |||||||||||
Net income (loss) | $ (31,503) | $ (36,950) | $ (30,511) | ||||||||
Weighted Average Number of Shares Outstanding, Basic and Diluted | 10,641 | 10,621 | 10,574 | ||||||||
Earnings Per Share, Basic and Diluted | $ (0.61) | $ (1.04) | $ (0.56) | $ (0.75) | $ (0.42) | $ (0.87) | $ (1.18) | $ (1) | $ (2.96) | $ (3.48) | $ (2.89) |
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 2,847 | 2,168 | 1,350 | ||||||||
Capped Call Instrument Member | |||||||||||
Anti-dilutive Securities | |||||||||||
Debt Conversion, Converted Instrument, Shares Issued | 0 | ||||||||||
Diluted net (loss) income per share | $ 0 | ||||||||||
Minimum | Capped Call Instrument Member | |||||||||||
Anti-dilutive Securities | |||||||||||
Debt Instrument, Convertible, Stock Price Trigger | $ 20 |
Revenue, Narratives (Details)
Revenue, Narratives (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||||||
Sep. 30, 2012 | Dec. 31, 2019USD ($)$ / shares | Sep. 30, 2019USD ($)$ / shares | Jun. 30, 2019USD ($)$ / shares | Mar. 31, 2019USD ($)$ / shares | Dec. 31, 2018USD ($)$ / shares | Sep. 30, 2018USD ($)$ / shares | Jun. 30, 2018USD ($)$ / shares | Mar. 31, 2018USD ($)$ / shares | Mar. 31, 2017USD ($) | Dec. 31, 2019USD ($)segment$ / shares | Dec. 31, 2018USD ($)$ / shares | Dec. 31, 2017USD ($)$ / shares | |
Revenue | |||||||||||||
Net revenue | $ 17,254 | $ 17,970 | $ 18,390 | $ 16,146 | $ 20,114 | $ 18,088 | $ 14,960 | $ 11,900 | $ 69,760 | $ 65,062 | $ 65,373 | ||
Cost of Goods Sold. | 15,671 | 14,613 | 16,643 | ||||||||||
Net Income (Loss) Attributable to Parent | $ (31,503) | $ (36,950) | $ (30,511) | ||||||||||
Earnings Per Share, Basic and Diluted | $ / shares | $ (0.61) | $ (1.04) | $ (0.56) | $ (0.75) | $ (0.42) | $ (0.87) | $ (1.18) | $ (1) | $ (2.96) | $ (3.48) | $ (2.89) | ||
Number of Reportable Segments | segment | 1 | ||||||||||||
Qsymia | |||||||||||||
Revenue | |||||||||||||
Months Of Returns Experience | 48 months | ||||||||||||
Qsymia | Minimum | |||||||||||||
Revenue | |||||||||||||
Product Shelf Life Term | 6 months | ||||||||||||
Potential Return Period | 24 months | ||||||||||||
Qsymia | Maximum | |||||||||||||
Revenue | |||||||||||||
Product Shelf Life Term | 12 months | ||||||||||||
Potential Return Period | 36 months | ||||||||||||
Change in Accounting Method Accounted for as Change in Estimate [Member] | |||||||||||||
Revenue | |||||||||||||
Gross Revenue Before Expected Returns Reserve And Gross To Net Charges | $ 17,900 | ||||||||||||
Expected Returns Reserve | 5,700 | ||||||||||||
Gross To Net Charges | 4,900 | ||||||||||||
Net revenue | 7,300 | ||||||||||||
Cost of Goods Sold. | 600 | ||||||||||||
Marketing Expense | $ 700 | ||||||||||||
Net Income (Loss) Attributable to Parent | $ 6,000 | ||||||||||||
Earnings Per Share, Basic and Diluted | $ / shares | $ 0.57 | ||||||||||||
Supply agreement | STENDRA/SPEDRA | |||||||||||||
Revenue | |||||||||||||
Expected Returns Reserve | $ 0 |
Revenue (Revenue By Geography)
Revenue (Revenue By Geography) (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Geographic Information | |||||||||||
Total revenue | $ 17,254 | $ 17,970 | $ 18,390 | $ 16,146 | $ 20,114 | $ 18,088 | $ 14,960 | $ 11,900 | $ 69,760 | $ 65,062 | $ 65,373 |
Qsymia | |||||||||||
Geographic Information | |||||||||||
Total revenue | 41,436 | 40,558 | 52,483 | ||||||||
PANCREAZE | |||||||||||
Geographic Information | |||||||||||
Total revenue | 22,856 | 17,334 | |||||||||
STENDRA/SPEDRA | |||||||||||
Geographic Information | |||||||||||
Total revenue | 5,468 | 7,170 | 12,890 | ||||||||
U.S. | |||||||||||
Geographic Information | |||||||||||
Total revenue | 58,052 | 58,430 | 55,892 | ||||||||
ROW | |||||||||||
Geographic Information | |||||||||||
Total revenue | 11,708 | 6,632 | 9,481 | ||||||||
Germany | |||||||||||
Geographic Information | |||||||||||
Total revenue | 5,500 | 5,500 | 7,000 | ||||||||
Canada | |||||||||||
Geographic Information | |||||||||||
Total revenue | 2,500 | 1,100 | |||||||||
South Korea | |||||||||||
Geographic Information | |||||||||||
Total revenue | 3,700 | 2,500 | |||||||||
Net Product Revenue | |||||||||||
Geographic Information | |||||||||||
Total revenue | 59,049 | 56,784 | 44,983 | ||||||||
Net Product Revenue | Qsymia | |||||||||||
Geographic Information | |||||||||||
Total revenue | 37,750 | 40,558 | 44,983 | ||||||||
Net Product Revenue | PANCREAZE | |||||||||||
Geographic Information | |||||||||||
Total revenue | 21,299 | 16,226 | |||||||||
Net Product Revenue | U.S. | Qsymia | |||||||||||
Geographic Information | |||||||||||
Total revenue | 37,750 | 40,558 | 44,983 | ||||||||
Net Product Revenue | U.S. | PANCREAZE | |||||||||||
Geographic Information | |||||||||||
Total revenue | 20,302 | 16,226 | |||||||||
Net Product Revenue | ROW | PANCREAZE | |||||||||||
Geographic Information | |||||||||||
Total revenue | 997 | ||||||||||
Royalty Revenue | |||||||||||
Geographic Information | |||||||||||
Total revenue | 3,577 | 3,415 | 2,483 | ||||||||
Royalty Revenue | PANCREAZE | |||||||||||
Geographic Information | |||||||||||
Total revenue | 1,557 | 1,108 | |||||||||
Royalty Revenue | STENDRA/SPEDRA | |||||||||||
Geographic Information | |||||||||||
Total revenue | 2,020 | 2,307 | 2,483 | ||||||||
Royalty Revenue | ROW | PANCREAZE | |||||||||||
Geographic Information | |||||||||||
Total revenue | 1,557 | 1,108 | |||||||||
Royalty Revenue | ROW | STENDRA/SPEDRA | |||||||||||
Geographic Information | |||||||||||
Total revenue | 2,020 | 2,307 | 2,483 | ||||||||
Supply Revenue | |||||||||||
Geographic Information | |||||||||||
Total revenue | 4,634 | 4,863 | 10,407 | ||||||||
Supply Revenue | Qsymia | |||||||||||
Geographic Information | |||||||||||
Total revenue | 1,186 | ||||||||||
Supply Revenue | STENDRA/SPEDRA | |||||||||||
Geographic Information | |||||||||||
Total revenue | 3,448 | 4,863 | 10,407 | ||||||||
Supply Revenue | U.S. | STENDRA/SPEDRA | |||||||||||
Geographic Information | |||||||||||
Total revenue | 1,646 | 5,909 | |||||||||
Supply Revenue | ROW | Qsymia | |||||||||||
Geographic Information | |||||||||||
Total revenue | 1,186 | ||||||||||
Supply Revenue | ROW | STENDRA/SPEDRA | |||||||||||
Geographic Information | |||||||||||
Total revenue | 3,448 | $ 3,217 | 4,498 | ||||||||
License revenue | |||||||||||
Geographic Information | |||||||||||
Total revenue | 2,500 | 7,500 | |||||||||
License revenue | Qsymia | |||||||||||
Geographic Information | |||||||||||
Total revenue | 2,500 | 7,500 | |||||||||
License revenue | U.S. | Qsymia | |||||||||||
Geographic Information | |||||||||||
Total revenue | 5,000 | ||||||||||
License revenue | ROW | Qsymia | |||||||||||
Geographic Information | |||||||||||
Total revenue | $ 2,500 | $ 2,500 |
Revenue (Revenue and Cost Of Go
Revenue (Revenue and Cost Of Goods Sold By Source) (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Geographic Information | |||||||||||
Total revenue | $ 17,254 | $ 17,970 | $ 18,390 | $ 16,146 | $ 20,114 | $ 18,088 | $ 14,960 | $ 11,900 | $ 69,760 | $ 65,062 | $ 65,373 |
Cost of goods sold (excluding amortization) | 15,671 | 14,613 | 16,643 | ||||||||
Amortization of intangible assets | 14,552 | 8,640 | 544 | ||||||||
Qsymia | |||||||||||
Geographic Information | |||||||||||
Total revenue | 41,436 | 40,558 | 52,483 | ||||||||
Cost of goods sold (excluding amortization) | 5,775 | 4,693 | 6,993 | ||||||||
Amortization of intangible assets | 362 | 363 | 544 | ||||||||
PANCREAZE | |||||||||||
Geographic Information | |||||||||||
Total revenue | 22,856 | 17,334 | |||||||||
Cost of goods sold (excluding amortization) | 6,460 | 5,156 | |||||||||
Amortization of intangible assets | 14,190 | 8,277 | |||||||||
STENDRA/SPEDRA | |||||||||||
Geographic Information | |||||||||||
Total revenue | 5,468 | 7,170 | 12,890 | ||||||||
Cost of goods sold (excluding amortization) | 3,436 | 4,764 | 9,650 | ||||||||
Net Product Revenue | |||||||||||
Geographic Information | |||||||||||
Total revenue | 59,049 | 56,784 | 44,983 | ||||||||
Net Product Revenue | Qsymia | |||||||||||
Geographic Information | |||||||||||
Total revenue | 37,750 | 40,558 | 44,983 | ||||||||
Net Product Revenue | PANCREAZE | |||||||||||
Geographic Information | |||||||||||
Total revenue | 21,299 | 16,226 | |||||||||
License revenue | |||||||||||
Geographic Information | |||||||||||
Total revenue | 2,500 | 7,500 | |||||||||
License revenue | Qsymia | |||||||||||
Geographic Information | |||||||||||
Total revenue | 2,500 | 7,500 | |||||||||
Supply Revenue | |||||||||||
Geographic Information | |||||||||||
Total revenue | 4,634 | 4,863 | 10,407 | ||||||||
Supply Revenue | Qsymia | |||||||||||
Geographic Information | |||||||||||
Total revenue | 1,186 | ||||||||||
Supply Revenue | STENDRA/SPEDRA | |||||||||||
Geographic Information | |||||||||||
Total revenue | 3,448 | 4,863 | 10,407 | ||||||||
Royalty Revenue | |||||||||||
Geographic Information | |||||||||||
Total revenue | 3,577 | 3,415 | 2,483 | ||||||||
Royalty Revenue | PANCREAZE | |||||||||||
Geographic Information | |||||||||||
Total revenue | 1,557 | 1,108 | |||||||||
Royalty Revenue | STENDRA/SPEDRA | |||||||||||
Geographic Information | |||||||||||
Total revenue | $ 2,020 | $ 2,307 | $ 2,483 |
Revenue Concentration of Custom
Revenue Concentration of Customers (Details) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Total revenues | Amerisource Bergen | |||
Concentration of Customers | |||
Concentration risk percentage | 30.00% | 34.00% | 32.00% |
Total revenues | McKesson | |||
Concentration of Customers | |||
Concentration risk percentage | 29.00% | 30.00% | 37.00% |
Total revenues | Cardinal Health, Inc. | |||
Concentration of Customers | |||
Concentration risk percentage | 26.00% | 28.00% | 29.00% |
Gross accounts receivable | Credit concentration | Amerisource Bergen | |||
Concentration of Customers | |||
Concentration risk percentage | 26.00% | 20.00% | |
Gross accounts receivable | Credit concentration | McKesson | |||
Concentration of Customers | |||
Concentration risk percentage | 24.00% | 5.00% | |
Gross accounts receivable | Credit concentration | Cardinal Health, Inc. | |||
Concentration of Customers | |||
Concentration risk percentage | 41.00% | 29.00% | |
Gross accounts receivable | Credit concentration | Johnson & Johnson | |||
Concentration of Customers | |||
Concentration risk percentage | 40.00% | ||
Research and development | Third party manufacturer | |||
Concentration of Customers | |||
Concentration risk percentage | 31.00% | 30.00% | 0.00% |
Cash, Cash Equivalents, And A_3
Cash, Cash Equivalents, And Available-For-Sale Securities (Fair Value of Cash, Cash Equivalents, and Available-For-Sale Securities) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Cash and cash equivalents and available-for-sale securities, Amortized Cost | ||
Cash and Cash Equivalents, at Carrying Value | $ 32,649 | $ 30,411 |
Available-for-sale securities including cash and cash equivalents, Amortized Cost Total | 111,520 | |
Less amounts classified as cash equivalents, Amortized Cost | (32,649) | (30,411) |
Available-for-sale Debt Securities, Amortized Cost Basis, Total | 81,109 | |
Available-for-sale securities, Gross Unrealized Gains | 43 | |
Available-for-sale securities, Gross Unrealized Losses | (314) | |
Debt Securities, Available-for-sale, Current | 0 | 80,838 |
Cash and cash equivalents and available-for-sale securities, Estimated Fair Value | ||
Cash and Cash Equivalents, Fair Value Disclosure | 32,649 | 30,411 |
Cash and cash equivalents and available for sale securities, Fair Value Disclosure | 111,249 | |
Less amounts classified as cash equivalents, Estimated Fair Value | (32,649) | (30,411) |
Debt Securities, Available-for-sale, Current | $ 0 | 80,838 |
Minimum, Maturity Period for Available to Support Current Operations Securities to Classify as Current Assets | 12 months | |
U.S. Treasury securities | ||
Cash and cash equivalents and available-for-sale securities, Amortized Cost | ||
Available-for-sale Debt Securities, Amortized Cost Basis, Total | 42,261 | |
Available-for-sale securities, Gross Unrealized Gains | 34 | |
Available-for-sale securities, Gross Unrealized Losses | (111) | |
Debt Securities, Available-for-sale, Current | 42,184 | |
Cash and cash equivalents and available-for-sale securities, Estimated Fair Value | ||
Debt Securities, Available-for-sale, Current | 42,184 | |
Corporate Debt Securities | ||
Cash and cash equivalents and available-for-sale securities, Amortized Cost | ||
Available-for-sale Debt Securities, Amortized Cost Basis, Total | 38,848 | |
Available-for-sale securities, Gross Unrealized Gains | 9 | |
Available-for-sale securities, Gross Unrealized Losses | (203) | |
Debt Securities, Available-for-sale, Current | 38,654 | |
Cash and cash equivalents and available-for-sale securities, Estimated Fair Value | ||
Debt Securities, Available-for-sale, Current | 38,654 | |
Cash and money market funds | ||
Cash and cash equivalents and available-for-sale securities, Amortized Cost | ||
Cash and Cash Equivalents, at Carrying Value | $ 32,649 | 30,411 |
Less amounts classified as cash equivalents, Amortized Cost | (32,649) | (30,411) |
Cash and cash equivalents and available-for-sale securities, Estimated Fair Value | ||
Cash and Cash Equivalents, Fair Value Disclosure | 32,649 | 30,411 |
Less amounts classified as cash equivalents, Estimated Fair Value | $ (32,649) | $ (30,411) |
Cash, Cash Equivalents, And A_4
Cash, Cash Equivalents, And Available-For-Sale Securities (Fair Value Hierarchy for Cash Equivalents and Available-For-Sale Securities) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Fair value measurements | ||
Cash and Cash Equivalents, Fair Value Disclosure | $ 32,649 | $ 30,411 |
Debt Securities, Available-for-sale, Current | 0 | 80,838 |
Cash and cash equivalents and available for sale securities, Fair Value Disclosure | 111,249 | |
U.S. Treasury securities | ||
Fair value measurements | ||
Debt Securities, Available-for-sale, Current | 42,184 | |
Corporate Debt Securities | ||
Fair value measurements | ||
Debt Securities, Available-for-sale, Current | 38,654 | |
Level 1 | ||
Fair value measurements | ||
Cash and Cash Equivalents, Fair Value Disclosure | $ 32,649 | 30,411 |
Cash and cash equivalents and available for sale securities, Fair Value Disclosure | 72,595 | |
Level 1 | U.S. Treasury securities | ||
Fair value measurements | ||
Debt Securities, Available-for-sale, Current | 42,184 | |
Level 2 | ||
Fair value measurements | ||
Cash and cash equivalents and available for sale securities, Fair Value Disclosure | 38,654 | |
Level 2 | Corporate Debt Securities | ||
Fair value measurements | ||
Debt Securities, Available-for-sale, Current | $ 38,654 |
Accounts Receivable (Details)
Accounts Receivable (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Accounts Receivable, before Allowance for Credit Loss, Current | $ 22,590 | $ 25,760 |
Accounts receivable, net | 22,338 | 25,608 |
Allowance for cash discounts member | ||
Allowance for cash discounts | 0 | 0 |
Qsymia | ||
Accounts Receivable, before Allowance for Credit Loss, Current | 15,423 | 13,987 |
Qsymia | Allowance for cash discounts member | ||
Allowance for cash discounts | (252) | (152) |
PANCREAZE | ||
Accounts Receivable, before Allowance for Credit Loss, Current | 6,380 | 10,213 |
STENDRA/SPEDRA | ||
Accounts Receivable, before Allowance for Credit Loss, Current | $ 787 | $ 1,560 |
Inventories (Details)
Inventories (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Inventory balances | ||
Raw materials | $ 26,313 | $ 17,813 |
Work in process | 2,908 | 1,719 |
Finished goods | 4,458 | 3,600 |
Inventories, net | $ 33,679 | $ 23,132 |
Prepaid Expenses And Other Cu_3
Prepaid Expenses And Other Current Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
OTHER CURRENT ASSETS | ||
Prepaid insurance | $ 2,029 | $ 1,451 |
Prepaid sales and marketing expenses | 1,806 | 1,525 |
Taxes receivable | 1,196 | 779 |
Other prepaid expenses and assets | 3,103 | 3,783 |
Total | $ 8,134 | $ 7,538 |
Property And Equipment (Details
Property And Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Property and Equipment | ||
Property and equipment, gross | $ 2,952 | $ 2,910 |
Accumulated depreciation | (2,719) | (2,569) |
Property and equipment, net | 233 | 341 |
Computers and software | ||
Property and Equipment | ||
Property and equipment, gross | 2,041 | 1,999 |
Furniture and fixtures | ||
Property and Equipment | ||
Property and equipment, gross | 185 | 185 |
Manufacturing equipment | ||
Property and Equipment | ||
Property and equipment, gross | 213 | 213 |
Leasehold improvements | ||
Property and Equipment | ||
Property and equipment, gross | $ 513 | $ 513 |
Intangible and Other Non Curren
Intangible and Other Non Current Assets (Narratives) (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Jun. 30, 2018 | Sep. 30, 2014 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Accumulated Amortization | $ (25,426) | $ (10,874) | |||
Net intangible assets | 119,519 | ||||
Long-term receivables | 413 | ||||
Prepaid Expense Other, Noncurrent | 208 | 208 | |||
Other Assets, Noncurrent | 145,566 | 145,153 | |||
Other Assets, Miscellaneous, Noncurrent | 120,140 | 134,279 | |||
Amortization of intangible assets | 14,552 | 8,640 | $ 544 | ||
Patents | Janssen | |||||
Finite-Lived Intangible Assets, Gross | 3,050 | 3,050 | |||
Accumulated Amortization | (2,959) | (2,597) | |||
Net intangible assets | 91 | 453 | |||
License | PANCREAZE | |||||
Finite-Lived Intangible Assets, Gross | 141,895 | 141,895 | |||
Accumulated Amortization | (22,467) | (8,277) | |||
Net intangible assets | $ 119,428 | $ 133,618 | |||
PANCREAZE | License | |||||
Finite-Lived Intangible Asset, Useful Life | 10 years | ||||
Janssen | Patents | |||||
Finite-Lived Intangible Asset, Useful Life | 5 years 6 months | ||||
Finite-Lived Patents, Gross | $ 3,100 |
Intangible and Other Non Curr_2
Intangible and Other Non Current Assets (Intangible Future Expected Amortization Expenses) (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Finite-Lived Intangible Assets, Net [Abstract] | |
2020 | $ 14,280 |
2021 | 14,190 |
2022 | 14,189 |
2023 | 14,190 |
2024 | 14,189 |
Thereafter | 48,481 |
Net intangible assets | $ 119,519 |
Accrued And Other Liabilities_2
Accrued And Other Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
ACCRUED AND OTHER LIABILITIES | ||
Reserve for product returns (See Note 2) | $ 14,874 | $ 14,878 |
Product-related accruals (see Note 2) | 6,663 | 8,272 |
Accrued manufacturing costs | 3,105 | 4,313 |
Accrued employee compensation and benefits | 2,777 | 2,591 |
Accrued interest on debt (see Note 13) | 1,351 | |
Other accrued liabilities | 3,628 | 2,990 |
Total | $ 32,398 | $ 33,044 |
Non-Current Accrued And Other_2
Non-Current Accrued And Other Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
NON-CURRENT ACCRUED AND OTHER LIABILITIES | ||
Non-current accrued and other liabilities | $ 0 | $ 234 |
Deferred Revenue (Details)
Deferred Revenue (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
SPEDRA | Royalties | ||
DEFERRED REVENUE | ||
Contract with Customer, Liability, Revenue Recognized | $ 1.2 | $ 1.2 |
License, Commercialization An_2
License, Commercialization And Supply Agreements (Details) $ / shares in Units, $ in Thousands | Jun. 26, 2019 | May 31, 2019country | Dec. 31, 2018 | Jun. 30, 2018USD ($)$ / sharesshares | Oct. 31, 2016 | Nov. 30, 2013 | Jul. 31, 2013country | Dec. 31, 2019USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($)$ / sharesshares | Mar. 31, 2018USD ($) | Sep. 30, 2017USD ($) | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) |
License, Commercialization, and Development Agreements with Third Parties | |||||||||||||||||||
Net revenue | $ 17,254 | $ 17,970 | $ 18,390 | $ 16,146 | $ 20,114 | $ 18,088 | $ 14,960 | $ 11,900 | $ 69,760 | $ 65,062 | $ 65,373 | ||||||||
Payments to Acquire Businesses, Gross | $ 135,000 | ||||||||||||||||||
PANCREAZE | Warrants Issued | |||||||||||||||||||
License, Commercialization, and Development Agreements with Third Parties | |||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Term | 7 years | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 61.60% | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Risk Free Interest Rate | 2.91% | ||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions, Expected Dividend Rate | 0.00% | ||||||||||||||||||
License revenue | |||||||||||||||||||
License, Commercialization, and Development Agreements with Third Parties | |||||||||||||||||||
Net revenue | 2,500 | 7,500 | |||||||||||||||||
License and Milestone Revenue | |||||||||||||||||||
License, Commercialization, and Development Agreements with Third Parties | |||||||||||||||||||
Net revenue | $ 2,500 | $ 7,500 | |||||||||||||||||
Janssen | PANCREAZE | |||||||||||||||||||
License, Commercialization, and Development Agreements with Third Parties | |||||||||||||||||||
Payments to Acquire Businesses, Gross | $ 135,000 | ||||||||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares | 357,000 | 357,000 | |||||||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 3.70 | $ 3.70 | |||||||||||||||||
Finite-Lived License Agreements, Gross | $ 141,900 | $ 141,900 | |||||||||||||||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Current Liabilities, Other | 400 | 400 | |||||||||||||||||
Business Combination Recognized Identifiable Assets Acquired And Liabilities Assumed Accruals For Estimated Destruction Of Future Unsalable Inventory | 6,300 | ||||||||||||||||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Inventory | 2,100 | 2,100 | |||||||||||||||||
Willow Biopharma Member | PANCREAZE | |||||||||||||||||||
License, Commercialization, and Development Agreements with Third Parties | |||||||||||||||||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Current Liabilities, Other | 1,500 | $ 1,500 | |||||||||||||||||
Willow Biopharma Member | PANCREAZE | Warrants Issued | |||||||||||||||||||
License, Commercialization, and Development Agreements with Third Parties | |||||||||||||||||||
Business Combination, Consideration Transferred, Equity Interests Issued and Issuable | $ 800 | ||||||||||||||||||
License and commercialization agreement | SPEDRA | Menarini Group | Minimum | |||||||||||||||||||
License, Commercialization, and Development Agreements with Third Parties | |||||||||||||||||||
Number of European countries covered under the license agreement | country | 40 | ||||||||||||||||||
License and commercialization agreement | PANCREAZE | |||||||||||||||||||
License, Commercialization, and Development Agreements with Third Parties | |||||||||||||||||||
Acquired Finite-lived Intangible Assets, Weighted Average Useful Life | 10 years | ||||||||||||||||||
License and commercialization agreement | License and Milestone Revenue | Alvogen | |||||||||||||||||||
License, Commercialization, and Development Agreements with Third Parties | |||||||||||||||||||
Net revenue | $ 2,500 | $ 2,500 | |||||||||||||||||
Amendment No. 1 License and Commercialization and Commercial Supply Agreement Member | Avanafil Tablets | Menarini Group | Minimum | |||||||||||||||||||
License, Commercialization, and Development Agreements with Third Parties | |||||||||||||||||||
Number of European countries covered under the license agreement | country | 40 | ||||||||||||||||||
Manufacturing and Supply Agreement Member | Avanafil Tablets | Sanofi Winthrop | |||||||||||||||||||
License, Commercialization, and Development Agreements with Third Parties | |||||||||||||||||||
Long-term Purchase Commitment, Period | 5 years | ||||||||||||||||||
Amendment No. 1 to Manufacturing and Supply Agreement Member | Avanafil Tablets | Sanofi Winthrop | |||||||||||||||||||
License, Commercialization, and Development Agreements with Third Parties | |||||||||||||||||||
Long Term Purchase Commitment Automatic Renewal of Additional Term | 1 year | ||||||||||||||||||
Amended Nordmark Supply Agreement June 26, 2019 member | Janssen | PANCREAZE | |||||||||||||||||||
License, Commercialization, and Development Agreements with Third Parties | |||||||||||||||||||
Long Term Purchase Commitment Automatic Renewal of Additional Term | 5 years | ||||||||||||||||||
Supply agreement | Sanofi Chimie | |||||||||||||||||||
License, Commercialization, and Development Agreements with Third Parties | |||||||||||||||||||
Long-term Purchase Commitment, Period | 5 years | ||||||||||||||||||
Long Term Purchase Commitment Automatic Renewal of Additional Term | 1 year | ||||||||||||||||||
Supply agreement | STENDRA/SPEDRA | Metuchen | |||||||||||||||||||
License, Commercialization, and Development Agreements with Third Parties | |||||||||||||||||||
Long-term Purchase Commitment, Period | 5 years | ||||||||||||||||||
Long Term Purchase Commitment Automatic Renewal of Additional Term | 2 years | ||||||||||||||||||
Supply agreement | STENDRA/SPEDRA | Metuchen | Minimum | |||||||||||||||||||
License, Commercialization, and Development Agreements with Third Parties | |||||||||||||||||||
Termination notice of license and supply agreement | 2 years |
Long-Term Debt (Schedule of Deb
Long-Term Debt (Schedule of Debt) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Long-term debt | ||
Net carrying value | $ 241,727 | $ 294,446 |
Less current portion | 183,006 | |
Long-term debt | 58,721 | 294,446 |
Convertible Senior Notes Due 2020 | ||
Long-term debt | ||
Senior Secured Notes | 181,426 | 181,426 |
Unamortized discount (premium) and debt issuance costs | 1,580 | 6,358 |
Net carrying value | 183,006 | 187,784 |
Senior Secured Notes Due 2024 | ||
Long-term debt | ||
Senior Secured Notes | 61,351 | 110,000 |
Unamortized discount (premium) and debt issuance costs | (2,630) | (3,338) |
Net carrying value | $ 58,721 | $ 106,662 |
Long-Term Debt (Narrative) (Det
Long-Term Debt (Narrative) (Details) - USD ($) | May 29, 2013 | Sep. 30, 2019 | Oct. 31, 2018 | Jun. 30, 2018 | Dec. 31, 2018 | May 21, 2013 |
Long-term debt | ||||||
Gain (Loss) on Extinguishment of Debt | $ 1,427,000 | |||||
Convertible Senior Notes Due 2020 | ||||||
Long-term debt | ||||||
Offering amount | $ 250,000,000 | |||||
Debt Instrument, Interest Rate, Stated Percentage | 4.50% | |||||
Net proceeds from offering | $ 241,800,000 | |||||
Conversion price per share (in dollars per share) | $ 148.58 | |||||
Repurchased Convertible Notes Face Value | $ 8,600,000 | $ 60,000,000 | ||||
Cash payment repurchased convertible notes | 7,100,000 | $ 51,000,000 | ||||
Gain (Loss) on Extinguishment of Debt | $ 1,400,000 | |||||
Senior Secured Note Athyrium Due 2024 | ||||||
Long-term debt | ||||||
Long-term Debt, Weighted Average Interest Rate, at Point in Time | 11.30% | |||||
Senior Secured Note Athyrium Due 2024 | Athyrium Capital Management Affiliates Member | ||||||
Long-term debt | ||||||
Debt Instrument, Interest Rate, Stated Percentage | 10.375% | |||||
Senior Notes | $ 110,000,000 | |||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 330,000 | |||||
Debt Instrument, Redemption Price, Percentage of Principal Amount Redeemed | 99.00% | |||||
Senior Secured Note Athyrium Due 2024 | Warrants Issued | Athyrium Capital Management Affiliates Member | ||||||
Long-term debt | ||||||
Expected life (in years) | 6 years | |||||
Volatility (as a percent) | 62.70% | |||||
Risk-free interest rate (as a percent) | 2.83% | |||||
Dividend yield (as a percent) | 0.00% | |||||
Additional Senior Secured Note Athyrium Due 2024 | Athyrium Capital Management Affiliates Member | ||||||
Long-term debt | ||||||
Debt Instrument, Interest Rate, Stated Percentage | 10.375% | |||||
Senior Notes | $ 10,000,000 | |||||
Debt Instrument, Term | 12 months | |||||
Senior Secured Notes Due 2024 | ||||||
Long-term debt | ||||||
Cash payment repurchased convertible notes | $ 48,600,000 | |||||
Gain (Loss) on Extinguishment of Debt | 0 | |||||
Senior Secured Notes Due 2024 | Interest Expense [Member] | ||||||
Long-term debt | ||||||
Prepayment premiums | $ 6,400,000 |
Long Term Debt (Long Term Debt
Long Term Debt (Long Term Debt Future Amortization) (Details) $ in Thousands | Dec. 31, 2019USD ($) |
LONG-TERM DEBT AND COMMITMENTS | |
2020 | $ 192,327 |
2021 | 20,152 |
2022 | 23,034 |
2023 | 21,076 |
2024 | 9,822 |
Total | $ 266,411 |
Leases - Schedule of Lease Asse
Leases - Schedule of Lease Assets & Liabilities (Details) - USD ($) $ in Thousands | Jan. 01, 2019 | Dec. 31, 2019 |
Lessee, Lease, Description [Line Items] | ||
Operating Lease, Right-of-Use Asset | $ 1,201 | $ 781 |
Finance Lease, Right-of-Use Asset | 329 | 354 |
Right of Use Assets | $ 1,530 | $ 1,135 |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | Vvus:RightOfUseAssets | Vvus:RightOfUseAssets |
Operating Lease, Liability, Current | $ 512 | $ 551 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Vvus:LeaseLiabilityCurrent | Vvus:LeaseLiabilityCurrent |
Finance Lease, Liability, Current | $ 131 | $ 216 |
Current portion of lease liability | 643 | 767 |
Operating Lease, Liability, Noncurrent | $ 1,017 | $ 466 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Vvus:LeaseLiabilityNoncurrent | Vvus:LeaseLiabilityNoncurrent |
Finance Lease, Liability, Noncurrent | $ 188 | $ 136 |
Lease liability, net of current portion | 1,205 | 602 |
Current Portion of Deferred Rent | (94) | |
Cumulative effect of accounting change | $ 10 | |
Accounting Standards Update 2016-02 [Member] | ||
Lessee, Lease, Description [Line Items] | ||
Cumulative effect of accounting change | 10 | |
Building [Member] | ||
Lessee, Lease, Description [Line Items] | ||
Deferred Rent, Net of Current Portion | $ (234) |
Lease - Narratives (Details)
Lease - Narratives (Details) | Jan. 01, 2019 | Dec. 31, 2019 |
Lessee, Lease, Description [Line Items] | ||
Operating Lease Remaining Term | 1 year 8 months 12 days | |
Finance Lease, Weighted Average Discount Rate, Percent | 2.90% | |
Finance Lease Remaining Term | 1 year 8 months 12 days | |
Options to Extend the Operating Leases | 2 years | |
Options to Extend the Finance Lease | 2 years | |
Lessee, Operating Lease, Existence of Option to Extend [true false] | true | |
Operating Lease, Weighted Average Discount Rate, Percent | 7.80% | |
Maximum | ||
Lessee, Lease, Description [Line Items] | ||
Operating Lease Remaining Term | 1 year | |
Finance Lease Remaining Term | 2 years 7 months 6 days | |
Minimum | ||
Lessee, Lease, Description [Line Items] | ||
Operating Lease Remaining Term | 2 years 7 months 6 days | |
Finance Lease Remaining Term | 1 year |
Leases - Lease Cost and Lease B
Leases - Lease Cost and Lease BS Info (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2019 | Jan. 01, 2019 | |
Lessee Lease Description [Abstract] | ||
Operating Lease, Cost | $ 521 | |
Finance Lease, Right-of-Use Asset, Amortization | 211 | |
Finance Lease, Interest Expense | 11 | |
Total Finance Lease Cost | 222 | |
Operating Lease, Right-of-Use Asset | 781 | $ 1,201 |
Finance Lease, Right-of-Use Asset | 354 | 329 |
Right of Use Assets | 1,135 | 1,530 |
Operating Lease, Liability, Current | 551 | 512 |
Finance Lease, Liability, Current | 216 | 131 |
Current portion of lease liability | 767 | 643 |
Operating Lease, Liability, Noncurrent | 466 | 1,017 |
Finance Lease, Liability, Noncurrent | 136 | 188 |
Lease liability, net of current portion | $ 602 | $ 1,205 |
Leases - Future Payment of Leas
Leases - Future Payment of Lease Liabilities (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Lessee, Operating Lease, Liability, Payment, Due [Abstract] | |
2020 (Operating Lease) | $ 610 |
2021 (Operating Lease) | 482 |
Total lease payments - Operating Lease | 1,092 |
Less imputed interest - Operating Lease | (75) |
Operating Lease Liabilities | $ 1,017 |
Operating Lease, Liability, Statement of Financial Position [Extensible List] | Vvus:LeaseLiabilityCurrent vvus:LeaseLiabilityNoncurrent |
Finance Lease, Liability, Payment, Due [Abstract] | |
2020 (Finance Lease) | $ 224 |
2021 (Finance Lease) | 117 |
2022 (Finance Lease) | 21 |
Total lease payments - Finance Lease | 362 |
Less imputed interest - Finance Lease | (10) |
Finance Lease Liability | $ 352 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) | Dec. 30, 2019$ / sharesshares | Sep. 10, 2018shares | Dec. 31, 2019$ / sharesshares | Dec. 31, 2018$ / sharesshares |
Capital stock | ||||
Common stock, shares authorized | 200,000,000 | 200,000,000 | ||
Common stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | ||
Common stock, shares issued | 10,649,000 | 10,636,000 | ||
Common stock, shares outstanding | 10,649,000 | 10,636,000 | ||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 | ||
Preferred stock, par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | ||
Preferred stock, shares issued | 0 | 0 | ||
Preferred stock, shares outstanding | 0 | 0 | ||
Reverse Stock Split Member | ||||
Capital stock | ||||
one-for-10 reverse stock split of common stock | 10 | 10 | ||
Shares of pre-reserve split common stock issued and outstanding | 10 | |||
Shares of post-reserve split common stock issued and outstanding | 1 | 1 | ||
Stockholder Rights Plan Member | ||||
Capital stock | ||||
Number of rights per common stock issued as dividend | 1 | |||
Class of Warrant or Right, Number of Securities Called by Each Warrant or Right | 1 | |||
New Stockholder Beneficial Ownership Percentage Triggering Potential Shareholder Dilution | 4.90% | |||
Threshold Percentage Of Existing Common Stock Holders Acquiring Additional One Percent Triggering Dilution | 4.90% | |||
Acquiring Person Additional Percentage Of Outstanding Shares Of Common Stock | 1.00% | |||
Stockholder Rights Plan Member | Series A Participating Preferred Stock | ||||
Capital stock | ||||
Initial Right Entitlement to Purchase Certain Preferred Stock Amount | 0.001 | |||
Exercise price of preferred stock for each right (in dollars per share) | $ / shares | $ 12.68 |
Stock Option and Purchase Pla_2
Stock Option and Purchase Plans (Narratives) (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||||
Jul. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Apr. 30, 2018 | Dec. 31, 2016 | |
Stock Option and Purchase Plans | ||||||
Stockholder Ownership Percentage | 5.00% | |||||
Stock options awards | ||||||
Stock Option and Purchase Plans | ||||||
Number of shares subject to outstanding options under the 2010 Plan | 2,747,243 | 2,441,062 | 1,422,581 | 954,724 | ||
Expected life (in years) | 4 years 8 months 12 days | 4 years 6 months | 4 years 3 months 7 days | |||
Expected Dividends | 0.00% | 0.00% | 0.00% | |||
Unrecognized estimated compensation expense | $ 3,000,000 | |||||
Weighted average remaining requisite service period | 2 years 3 months 18 days | |||||
Employee Stock Purchase Plan | ||||||
Stock Option and Purchase Plans | ||||||
Shares reserved for issuance to employees | 600,000 | |||||
Maximum payroll deductions for ESPP | 10.00% | |||||
ESPP maximum shares to be purchased per offering period | 1,000 | |||||
Percentage of purchase price of common stock at fair market value | 85.00% | |||||
Expected life (in years) | 6 months | 6 months | 6 months | |||
Cumulative number of shares issued under the plan to employees | 201,673 | |||||
Shares available for grant | 398,327 | |||||
Weighted average fair value of share issued (in dollars per share) | $ 1.16 | $ 1.63 | $ 2.28 | |||
Expected Dividends | 0.00% | 0.00% | 0.00% | |||
Unrecognized estimated compensation expense | $ 12,000 | |||||
Employee Stock Purchase Plan | Maximum | ||||||
Stock Option and Purchase Plans | ||||||
Weighted average remaining requisite service period | 6 months | |||||
Inducement Equity Incentive Plan 2018 member | Stock options awards | ||||||
Stock Option and Purchase Plans | ||||||
Shares reserved for issuance to employees | 502,000 | |||||
Equity Incentive Plan 2010 And 2001 Stock Option Plan Member | ||||||
Stock Option and Purchase Plans | ||||||
Number of shares subject to outstanding options under the 2010 Plan | 1,881,449 | |||||
Equity Incentive Plan 2018 member | ||||||
Stock Option and Purchase Plans | ||||||
Shares reserved for issuance to employees | 150,000 | |||||
Additional shares reserved but not issued pursued to 2010 Plan rolled over to 2018 Plan | 603,375 | |||||
Equity Incentive Plan 2018 member | Stock options awards | ||||||
Stock Option and Purchase Plans | ||||||
Aggregate intrinsic value of outstanding options | $ 0 | |||||
Shares available for grant | 997,075 | |||||
Equity Incentive Plan 2018 member | Stock options awards | Maximum | ||||||
Stock Option and Purchase Plans | ||||||
Options vesting period | 10 years | |||||
Equity Incentive Plan 2018 member | Incentive Stock Option to Ten Percent Stockholder Member | ||||||
Stock Option and Purchase Plans | ||||||
Stockholder Ownership Percentage | 10.00% | |||||
Equity Incentive Plan 2018 member | Incentive Stock Option to Ten Percent Stockholder Member | Maximum | ||||||
Stock Option and Purchase Plans | ||||||
Options vesting period | 5 years |
Stock Option and Purchase Plan
Stock Option and Purchase Plan (Activity Roll Forward) (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Stock options awards | |||
Number of Shares | |||
Balance at beginning of year (in shares) | 2,441,062 | 1,422,581 | 954,724 |
Granted (in shares) | 492,660 | 1,157,668 | 518,484 |
Exercised (in shares) | (10,029) | ||
Cancelled (in shares) | (186,479) | (129,158) | (50,627) |
Balance at end of year (in shares) | 2,747,243 | 2,441,062 | 1,422,581 |
Exercisable at end of year (in shares) | 1,862,669 | 1,124,744 | 653,183 |
Weighted-Average Exercise Price | |||
Balance at beginning of year (in dollars per share) | $ 20.92 | $ 34.12 | $ 46.23 |
Granted (in dollars per share) | 4.08 | 3.95 | 10.60 |
Exercised (in dollars per share) | 6.99 | ||
Cancelled (in dollars per share) | 5.73 | 15.27 | 21.66 |
Balance at end of year (in dollars per share) | 18.93 | 20.92 | 34.12 |
Exercisable at end of year (in dollars per share) | 25.70 | 39.25 | 60.72 |
Weighted average grant-date fair value of options granted during the year (in dollars per share) | $ 2.32 | $ 1.90 | $ 4.95 |
Restricted stock units | |||
Number of Restricted Stock Units | |||
Restricted stock units outstanding at the beginning of the period (in shares) | 1,045 | 29,133 | 53,843 |
Granted (in shares) | 45,000 | ||
Vested (in shares) | (957) | (19,185) | (62,192) |
Forfeited (in shares) | (8,903) | (7,518) | |
Restricted stock units outstanding at the end of the period (in shares) | 88 | 1,045 | 29,133 |
Weighted Average Grant Date Fair Value | |||
Restricted stock units outstanding at the beginning of the period (in dollars per shares) | $ 29.08 | $ 17.78 | $ 18.99 |
Granted (in dollars per share) | 11.73 | ||
Vested (in dollars per share) | 27.40 | 19.82 | 14.79 |
Forfeited (in dollars per share) | 12.05 | 14.99 | |
Restricted stock units outstanding at the end of the period (in dollars per shares) | $ 47.33 | $ 29.08 | $ 17.78 |
Stock Option and Purchase Pla_3
Stock Option and Purchase Plan (Stock Option and Purchase Plans by Exercise Prices) (Details) | 12 Months Ended |
Dec. 31, 2019$ / sharesshares | |
Exercise Prices Range One $2.81 - $3.70 | |
Summary of Stock Options | |
Exercise price, low end of the range (in dollars per share) | $ 2.81 |
Exercise price, high end of the range (in dollars per share) | $ 3.70 |
Options Outstanding | |
Number Outstanding at end of the period (in shares) | shares | 663,700 |
Weighted-Average Remaining Contractual Life | 4 years 2 months 9 days |
Weighted-Average Exercise Price (in dollars per share) | $ 3.66 |
Options Exercisable | |
Number Exercisable at the end of the period (in shares) | shares | 400,240 |
Weighted Average Exercise Price (in dollars per share) | $ 3.65 |
Exercise Prices Range Two $3.90 - $4.05 | |
Summary of Stock Options | |
Exercise price, low end of the range (in dollars per share) | 3.90 |
Exercise price, high end of the range (in dollars per share) | $ 4.05 |
Options Outstanding | |
Number Outstanding at end of the period (in shares) | shares | 669,560 |
Weighted-Average Remaining Contractual Life | 5 years 2 months 9 days |
Weighted-Average Exercise Price (in dollars per share) | $ 4.03 |
Options Exercisable | |
Number Exercisable at the end of the period (in shares) | shares | 183,902 |
Weighted Average Exercise Price (in dollars per share) | $ 4.02 |
Exercise Prices Range Three $4.07 - $10.60 | |
Summary of Stock Options | |
Exercise price, low end of the range (in dollars per share) | 4.07 |
Exercise price, high end of the range (in dollars per share) | $ 10.60 |
Options Outstanding | |
Number Outstanding at end of the period (in shares) | shares | 603,297 |
Weighted-Average Remaining Contractual Life | 3 years 4 months 2 days |
Weighted-Average Exercise Price (in dollars per share) | $ 9.17 |
Options Exercisable | |
Number Exercisable at the end of the period (in shares) | shares | 550,556 |
Weighted Average Exercise Price (in dollars per share) | $ 9.51 |
Exercise Prices Range Four $11.20 - $27.40 | |
Summary of Stock Options | |
Exercise price, low end of the range (in dollars per share) | 11.20 |
Exercise price, high end of the range (in dollars per share) | $ 27.40 |
Options Outstanding | |
Number Outstanding at end of the period (in shares) | shares | 557,930 |
Weighted-Average Remaining Contractual Life | 3 years 4 months 21 days |
Weighted-Average Exercise Price (in dollars per share) | $ 15.83 |
Options Exercisable | |
Number Exercisable at the end of the period (in shares) | shares | 475,215 |
Weighted Average Exercise Price (in dollars per share) | $ 16.63 |
Exercise Prices Range Five $27.90 - $257.40 | |
Summary of Stock Options | |
Exercise price, low end of the range (in dollars per share) | 27.90 |
Exercise price, high end of the range (in dollars per share) | $ 257.40 |
Options Outstanding | |
Number Outstanding at end of the period (in shares) | shares | 252,756 |
Weighted-Average Remaining Contractual Life | 1 year 4 months 10 days |
Weighted-Average Exercise Price (in dollars per share) | $ 128.69 |
Options Exercisable | |
Number Exercisable at the end of the period (in shares) | shares | 252,756 |
Weighted Average Exercise Price (in dollars per share) | $ 128.69 |
Exercise Prices Range Total $2.81 - $257.4 | |
Summary of Stock Options | |
Exercise price, low end of the range (in dollars per share) | 2.81 |
Exercise price, high end of the range (in dollars per share) | $ 257.40 |
Options Outstanding | |
Number Outstanding at end of the period (in shares) | shares | 2,747,243 |
Weighted-Average Remaining Contractual Life | 3 years 9 months 26 days |
Weighted-Average Exercise Price (in dollars per share) | $ 18.93 |
Options Exercisable | |
Number Exercisable at the end of the period (in shares) | shares | 1,862,669 |
Weighted Average Exercise Price (in dollars per share) | $ 25.70 |
Stock Option and Purchase Pla_4
Stock Option and Purchase Plans (Valuation Assumptions) (Details) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Stock options awards | |||
Share-Based Compensation Expense | |||
Expected life (in years) | 4 years 8 months 12 days | 4 years 6 months | 4 years 3 months 7 days |
Volatility (as a percent) | 68.50% | 57.70% | 57.00% |
Risk-free interest rate (as a percent) | 2.57% | 2.70% | 1.80% |
Dividend yield (as a percent) | 0.00% | 0.00% | 0.00% |
Employee Stock Purchase Plan | |||
Share-Based Compensation Expense | |||
Expected life (in years) | 6 months | 6 months | 6 months |
Volatility (as a percent) | 64.40% | 91.50% | 47.40% |
Risk-free interest rate (as a percent) | 2.00% | 2.40% | 1.20% |
Dividend yield (as a percent) | 0.00% | 0.00% | 0.00% |
Stock Option and Purchase Pla_5
Stock Option and Purchase Plans (Share-based compensation by COS & OPEX) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-Based Compensation Expense | |||
Share-based compensation | $ 2,026 | $ 3,285 | $ 2,942 |
Total share-based compensation cost capitalized as part of cost of inventory | 39 | 26 | 9 |
Cost of goods sold | |||
Share-Based Compensation Expense | |||
Share-based compensation | 56 | 66 | 53 |
Selling and Marketing | |||
Share-Based Compensation Expense | |||
Share-based compensation | 280 | 349 | 371 |
General and Administrative | |||
Share-Based Compensation Expense | |||
Share-based compensation | 1,483 | 2,558 | 2,173 |
Research and development | |||
Share-Based Compensation Expense | |||
Share-based compensation | $ 207 | $ 312 | $ 345 |
Stock Option and Purchase Pla_6
Stock Option and Purchase Plans (Share Based Compensation by Type of Awards) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-Based Compensation Expense | |||
Share-based compensation | $ 2,026 | $ 3,285 | $ 2,942 |
Restricted stock units | |||
Share-Based Compensation Expense | |||
Share-based compensation | 249 | 924 | |
Stock options awards | |||
Share-Based Compensation Expense | |||
Share-based compensation | 2,007 | 3,007 | 2,002 |
Employee Stock Purchase Plan | |||
Share-Based Compensation Expense | |||
Share-based compensation | $ 19 | $ 29 | $ 16 |
Commitments Narratives (Details
Commitments Narratives (Details) | 1 Months Ended | 12 Months Ended | |
Aug. 31, 2016ft²USD ($)$ / item | Dec. 31, 2019USD ($) | Jan. 01, 2019 | |
Lessee, Lease, Description [Line Items] | |||
Lessee, Operating Lease, Renewal Term | 2 years | ||
Fda Approval Qsymia Pmr And Cvot Member | |||
Lessee, Lease, Description [Line Items] | |||
Unrecorded Unconditional Purchase Obligation, Term | 5 years | ||
Marketing Expense | $ 0 | ||
Fda Approval Qsymia Pmr And Cvot Member | Minimum | |||
Lessee, Lease, Description [Line Items] | |||
Contractual Obligation | 180,000,000 | ||
Fda Approval Qsymia Pmr And Cvot Member | Maximum | |||
Lessee, Lease, Description [Line Items] | |||
Contractual Obligation | $ 220,000,000 | ||
Campbell Lease Member | |||
Lessee, Lease, Description [Line Items] | |||
Area of Real Estate Property | ft² | 13,981 | ||
Lessee, Operating Lease, Term of Contract | 58 months | ||
Operating Leases Base Monthly Rent Per Square Foot | $ / item | 3.10 | ||
Abatement Period Of Monthly Installments Of Rent | 4 months | ||
Lessee, Operating Lease, Renewal Term | 2 years | ||
Operating Leases Number Of Options To Extend Lease | 1 |
Commitments (Future minimum ope
Commitments (Future minimum operating leases) (Details) $ in Thousands | Dec. 31, 2019USD ($) |
Lessee, Lease, Description [Line Items] | |
2020 (Operating Lease) | $ 610 |
2021 (Operating Lease) | 482 |
Total lease payments - Operating Lease | 1,092 |
Office Building [Member] | |
Lessee, Lease, Description [Line Items] | |
2020 (Operating Lease) | 601 |
2021 (Operating Lease) | 482 |
Total lease payments - Operating Lease | $ 1,083 |
Income Taxes (Deferred Tax Asse
Income Taxes (Deferred Tax Assets) (Details) - USD ($) $ in Thousands | Dec. 31, 2019 | Dec. 31, 2018 |
Deferred tax assets: | ||
Net operating loss carry forwards | $ 160,464 | $ 152,172 |
Research and development credit carry forwards | 16,859 | 16,721 |
Share-based compensation | 5,113 | 5,086 |
Accruals and other | 13,655 | 15,180 |
Depreciation | 265 | 633 |
Deferred revenue | 960 | 1,268 |
Deferred tax assets, gross | 197,316 | 191,060 |
Valuation allowance | (197,316) | (191,060) |
Total | $ 0 | $ 0 |
Income Taxes (Narratives) (Deta
Income Taxes (Narratives) (Details) - USD ($) $ in Thousands | Dec. 22, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Operating loss carryforwards | ||||
Net increase (decrease) in valuation allowance | $ 6,300 | $ 200 | ||
Deferred tax liabilities | $ 0 | |||
Tax at U.S. federal statutory rate | 35.00% | 21.00% | 21.00% | 35.00% |
Stockholder Ownership Percentage | 5.00% | |||
Ownership Change Rolling Term | 3 years | |||
Income Tax Examination, Penalties and Interest Expense | $ 0 | |||
Minimum | ||||
Operating loss carryforwards | ||||
Change in Ownership Percentage | 50.00% | |||
US Tax Cuts Jobs Act | ||||
Operating loss carryforwards | ||||
Net increase (decrease) in valuation allowance | $ (98,400) | |||
Tax at U.S. federal statutory rate | 21.00% | |||
Revaluation of Deferred Tax Assets | $ 98,400 | |||
Officer Compensation Expense under Covered Employee Deduction Limitation U.S. Internal Revenue Code | 0 | |||
US Tax Cuts Jobs Act | Maximum | ||||
Operating loss carryforwards | ||||
Effective Income Tax Rate Reconciliation Deduction Compensation Cost To Covered Employee Amount | $ 1,000 | |||
Canada Revenue Agency [Member] | ||||
Operating loss carryforwards | ||||
Statute of Limitations | 3 years | |||
Tax and Customs Administration, Netherlands [Member] | ||||
Operating loss carryforwards | ||||
Statute of Limitations | 5 years | |||
Federal income tax | ||||
Operating loss carryforwards | ||||
Net operating loss carryforwards | $ 648,500 | |||
Operating Loss Carryforwards, Expiration Date | Jan. 1, 2028 | |||
Federal income tax | Research Tax Credit Carryforward [Member] | ||||
Operating loss carryforwards | ||||
Tax Credit Carryforward, Amount | $ 12,900 | |||
Federal income tax | Federal NOLs generated prior to Tax Years beginning 2018 Member | ||||
Operating loss carryforwards | ||||
Net operating loss carryforwards | $ 633,600 | |||
Net Operating Loss Carryforwards Offset Against Federal Taxable Income Percentage | 100.00% | |||
Federal income tax | Federal NOLs Arose in Tax Years Beginning After 2017 Member | ||||
Operating loss carryforwards | ||||
Net operating loss carryforwards | $ 14,900 | |||
Federal income tax | Maximum | Federal NOLs Arose in Tax Years Beginning After 2017 Member | ||||
Operating loss carryforwards | ||||
Net Operating Loss Carryforwards Offset Against Federal Taxable Income Percentage | 80.00% | |||
Federal income tax | US Tax Cuts Jobs Act | ||||
Operating loss carryforwards | ||||
Percentage Of Adjusted Taxable Income Component Of Business Interest Expense Limitation | 30.00% | |||
Effective Income Tax Rate Reconciliation, Deduction, Business Interest Expense, Amount | $ 20,700 | |||
Modified Depreciation Provisions Allowable Deduction Percentage For Eligible Property Placed In Service | 100.00% | |||
Allowable Bonus Depreciation Years | 4 years | |||
Bonus Depreciation Deductible for Cost of Eligible Property Amount | $ 40 | |||
Federal income tax | US Tax Cuts Jobs Act | Tax Year 2023 member | ||||
Operating loss carryforwards | ||||
Allowable Bonus Depreciation Percentage Eligible Property In Year Placed In Service | 80.00% | |||
Federal income tax | US Tax Cuts Jobs Act | Tax Year 2024 member | ||||
Operating loss carryforwards | ||||
Allowable Bonus Depreciation Percentage Eligible Property In Year Placed In Service | 60.00% | |||
Federal income tax | US Tax Cuts Jobs Act | Tax Year 2025 member | ||||
Operating loss carryforwards | ||||
Allowable Bonus Depreciation Percentage Eligible Property In Year Placed In Service | 40.00% | |||
Federal income tax | US Tax Cuts Jobs Act | Tax Year 2026 member | ||||
Operating loss carryforwards | ||||
Allowable Bonus Depreciation Percentage Eligible Property In Year Placed In Service | 20.00% | |||
State income tax | ||||
Operating loss carryforwards | ||||
Net operating loss carryforwards | $ 278,200 | |||
State income tax | Research Tax Credit Carryforward [Member] | ||||
Operating loss carryforwards | ||||
Tax Credit Carryforward, Amount | 5,200 | |||
Foreign Tax Authority [Member] | US Tax Cuts Jobs Act - GILTI Member | ||||
Operating loss carryforwards | ||||
Tax Cuts and Jobs Act, Change in Tax Rate, Deferred Tax Asset, Income Tax Expense | 200 | |||
Tax Cuts and Jobs Act, Change in Tax Rate, Income Tax Expense (Benefit) | $ 0 |
Income Taxes (Income Taxes Prov
Income Taxes (Income Taxes Provision) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Loss before income taxes: | |||
Domestic | $ (31,643) | $ (36,800) | $ (30,371) |
International | 161 | (98) | (138) |
Loss before income taxes | (31,482) | (36,898) | (30,509) |
Current | |||
Federal | 0 | 0 | 0 |
State | 21 | 57 | 2 |
Foreign | (5) | 0 | |
Total current provision (benefit) for income taxes | 21 | 52 | 2 |
Deferred | |||
Foreign | 0 | 0 | 0 |
State | 0 | 0 | 0 |
Federal | 0 | 0 | 0 |
Total deferred provision for income taxes | 0 | 0 | 0 |
Total provision (benefit) for income taxes from continuing operations | $ 21 | $ 52 | $ 2 |
Income Taxes (Income Taxes Reco
Income Taxes (Income Taxes Reconciliation) (Details) - USD ($) $ in Thousands | Dec. 22, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2019 | Dec. 31, 2018 |
Reconciliation between the U.S. federal statutory tax rate and effective tax rate from continuing operations | ||||||
Tax at U.S. federal statutory rate | 35.00% | 21.00% | 21.00% | 35.00% | ||
State income taxes, net of federal tax effect | 1.00% | 2.00% | 1.00% | |||
Change in valuation allowance | (23.00%) | (2.00%) | 310.00% | |||
Permanent items | (21.00%) | (24.00%) | ||||
Tax credits | 1.00% | 1.00% | ||||
Tax Cuts and Jobs Act impact | (323.00%) | |||||
Effective tax rate (as a percent) | 0.00% | 0.00% | 0.00% | |||
Reconciliation of beginning and ending amount of unrecognized tax benefits | ||||||
Unrecognized tax benefits at the beginning of period | $ 91 | $ 110 | $ 65 | |||
Gross increase for tax positions of prior years | 3 | |||||
Gross decrease for tax positions of prior years | (33) | |||||
Gross increase/(decrease) for tax positions of current year | 93 | 14 | 45 | |||
Unrecognized tax benefits balance as the ending of period | 187 | 91 | 110 | |||
Unrecognized tax benefits recorded on consolidated balance sheets | ||||||
Total unrecognized tax benefits | $ 187 | $ 91 | $ 110 | $ 187 | $ 91 | |
Amounts netted against deferred tax assets | (187) | (91) | ||||
Unrecognized tax benefits recorded on consolidated balance sheets | $ 0 | $ 0 |
401(k) Plan (Details)
401(k) Plan (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Compensation and Retirement Disclosure | |||
401(k) Plan employer-matching contributions | $ 256,000 | $ 277,000 | $ 272,000 |
Selected Financial Data (Unau_2
Selected Financial Data (Unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Selected Financial Data (Unaudited) | |||||||||||
Total revenue | $ 17,254 | $ 17,970 | $ 18,390 | $ 16,146 | $ 20,114 | $ 18,088 | $ 14,960 | $ 11,900 | $ 69,760 | $ 65,062 | $ 65,373 |
Total gross profit | 13,284 | 14,954 | 14,013 | 11,838 | 14,901 | 14,604 | 11,674 | 9,270 | |||
Operating expenses | 20,932 | 19,127 | 20,437 | 20,233 | 18,357 | 17,680 | 18,312 | 14,192 | |||
Net Loss | $ (6,547) | $ (11,072) | $ (5,935) | $ (7,949) | $ (4,500) | $ (9,223) | $ (12,574) | $ (10,653) | $ (31,503) | $ (36,950) | $ (30,511) |
Basic and diluted net (loss) per share: | |||||||||||
Basic and diluted net loss per share (in dollars per share) | $ (0.61) | $ (1.04) | $ (0.56) | $ (0.75) | $ (0.42) | $ (0.87) | $ (1.18) | $ (1) | $ (2.96) | $ (3.48) | $ (2.89) |
Schedule II-Valuation And Qua_2
Schedule II-Valuation And Qualifying Accounts (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Allowance for cash discounts member | |||
Changes in valuation and qualifying accounts reported as assets and liabilities of continuing and discontinued operations | |||
Balance at Beginning of Period | $ 152,000 | $ 195,000 | $ 213,000 |
Charged to Operations | 1,921,000 | 1,346,000 | 1,344,000 |
Charges Utilized | (1,821,000) | (1,389,000) | (1,362,000) |
Balance at End of Period | 252,000 | 152,000 | 195,000 |
Cash Discount Allowance Related To Revenue Recognized Member | |||
Changes in valuation and qualifying accounts reported as assets and liabilities of continuing and discontinued operations | |||
Charged to Operations | $ 1,965,000 | $ 1,327,000 | $ 1,697,000 |