Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Mar. 26, 2021 | Jun. 30, 2020 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2020 | ||
Entity Registrant Name | TITAN PHARMACEUTICALS INC | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Title of 12(b) Security | Common Stock, par value $0.001 | ||
Trading Symbol | TTNP | ||
Security Exchange Name | NASDAQ | ||
Entity Common Stock, Shares Outstanding | 9,864,068 | ||
Entity Public Float | $ 29.7 | ||
Entity Central Index Key | 0000910267 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
BALANCE SHEETS
BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 5,413 | $ 5,223 |
Receivables | 884 | 438 |
Inventory | 328 | 563 |
Prepaid expenses and other current assets | 522 | 534 |
Discontinued operations - current assets | 181 | 1,550 |
Total current assets | 7,328 | 8,308 |
Property and equipment, net | 618 | 817 |
Operating lease right-of-use asset | 141 | 397 |
Total Assets | 8,087 | 9,522 |
Current liabilities: | ||
Accounts payable | 1,253 | 815 |
Accrued clinical trials expenses | 214 | 169 |
Other accrued liabilities | 319 | 264 |
Operating lease liability, current | 150 | 272 |
Current portion of long-term debt | 327 | 0 |
Discontinued operations - current liabilities | 1,960 | 2,080 |
Total current liabilities | 4,223 | 3,600 |
Long-term debt, net of debt discount of $0 and $346 | 332 | 4,019 |
Warrant liability | 0 | 320 |
Operating lease liability, non-current | 0 | 150 |
Total liabilities | 4,555 | 8,089 |
Commitments and contingencies (Note 5) | ||
Stockholders' equity | ||
Preferred stock, $0.001 par value per share; 5,000,000 shares authorized, none issued and outstanding at December 31, 2020 and 2019. | 0 | 0 |
Common stock, at amounts paid-in, $0.001 par value per share; 225,000,000 shares authorized 7,139,068 and 1,912,627 shares issued and outstanding at December 31, 2020 and 2019, respectively. | 7 | 2 |
Additional paid-in capital | 370,804 | 350,468 |
Accumulated deficit | (367,279) | (349,037) |
Total stockholders' equity | 3,532 | 1,433 |
Total liabilities and stockholders' equity | $ 8,087 | $ 9,522 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
BALANCE SHEETS | ||
Debt Instrument, Unamortized Discount, Noncurrent | $ 0 | $ 346 |
Preferred Stock, Par or Stated Value Per Share (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 or Stated Value Per Share (in dollars per share) | $ 0.001 | $ 0.001 |
Common Stock, Shares Authorized | 225,000,000 | 225,000,000 |
Common Stock, Shares, Issued | 7,139,068 | 1,912,627 |
Common Stock, Shares, Outstanding | 7,139,068 | 1,912,627 |
STATEMENTS OF OPERATIONS AND CO
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Revenue: | ||
Total revenue | $ 4,838 | $ 2,605 |
Operating expenses: | ||
Cost of goods sold | 472 | 0 |
Research and development | 5,916 | 5,080 |
General and administrative | 5,801 | 5,401 |
Total operating expenses | 12,189 | 10,481 |
Loss from operations | (7,351) | (7,876) |
Other income (expense): | ||
Interest expense, net | (769) | (967) |
Other income (expense), net | (258) | 17 |
Non-cash gain (loss) on changes in the fair value of warrants | (923) | 1,110 |
Non-cash gain on changes in the fair value of assets | 1,975 | 0 |
Non-cash gain (loss) on debt extinguishment | (81) | 226 |
Other income (expense), net | (56) | 386 |
Loss from continuing operations | (7,407) | (7,490) |
Loss on discontinued operations | (10,835) | (8,968) |
Net loss and comprehensive loss | $ (18,242) | $ (16,458) |
Basic and diluted net loss per common share from continuing operations | $ (1.96) | $ (9.78) |
Basic and diluted net loss per common share on discontinued operations | $ (2.87) | $ (11.71) |
Weighted average shares used in computing basic and diluted net loss per common share | 3,773 | 766 |
License revenue | ||
Revenue: | ||
Total revenue | $ 11 | $ 315 |
Product revenue | ||
Revenue: | ||
Total revenue | 528 | 0 |
Grant revenue | ||
Revenue: | ||
Total revenue | $ 4,299 | $ 2,290 |
STATEMENTS OF STOCKHOLDERS' EQU
STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Preferred Stock | Common Stock | Additional Paid-In Capital | Accumulated Deficit | Total |
Balance at Dec. 31, 2018 | $ 0 | $ 1 | $ 339,409 | $ (332,579) | $ 6,831 |
Balance (in shares) at Dec. 31, 2018 | 0 | 434,000 | |||
Net loss | $ 0 | $ 0 | 0 | (16,458) | (16,458) |
Issuance of common stock, net | $ 0 | $ 1 | 8,236 | 0 | 8,237 |
Issuance of common stock, net (in shares) | 0 | 1,257,000 | |||
Issuance of common stock upon exercises of warrants, net | $ 0 | $ 0 | 1,601 | 0 | 1,601 |
Issuance of common stock upon exercises of warrants, net (in shares) | 0 | 207,000 | |||
Issuance of common stock upon conversion of convertible debt | $ 0 | $ 0 | 650 | 0 | 650 |
Issuance of common stock upon conversion of convertible debt (in shares) | 0 | 15,000 | |||
Stock-based compensation | $ 0 | $ 0 | 572 | 0 | 572 |
Balance at Dec. 31, 2019 | $ 0 | $ 2 | 350,468 | (349,037) | 1,433 |
Balance (in shares) at Dec. 31, 2019 | 0 | 1,913,000 | |||
Net loss | $ 0 | $ 0 | 0 | (18,242) | (18,242) |
Issuance of common stock, net | $ 0 | $ 4 | 10,190 | 0 | 10,194 |
Issuance of common stock, net (in shares) | 0 | 3,605,000 | |||
Issuance of common stock upon exercises of warrants, net | $ 0 | $ 2 | 7,241 | 0 | $ 7,243 |
Issuance of common stock upon exercises of warrants, net (in shares) | 0 | 1,563,000 | 450,761 | ||
Reverse stock split adjustments | $ 0 | $ (1) | 1 | 0 | $ 0 |
Reverse stock split adjustments (in shares) | 0 | 58,000 | |||
Reclassification of liability-classified warrants to equity | $ 0 | $ 0 | 2,897 | 0 | 2,897 |
Stock-based compensation | 0 | 0 | 7 | 0 | 7 |
Balance at Dec. 31, 2020 | $ 0 | $ 7 | $ 370,804 | $ (367,279) | $ 3,532 |
Balance (in shares) at Dec. 31, 2020 | 0 | 7,139,000 |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (18,242) | $ (16,458) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Non-cash gain on difference between fair and carrying value of assets transferred in debt settlement | (1,975) | 0 |
Depreciation and amortization | 292 | 244 |
Non-cash interest expense | 498 | 613 |
Non-cash loss (gain) on changes in fair value of warrants | 923 | (1,110) |
Non-cash loss (gain) on debt extinguishment | 81 | (226) |
Stock-based compensation | 7 | 572 |
Finance costs for issuance of warrants | 211 | 0 |
Other | (16) | (41) |
Changes in operating assets and liabilities: | ||
Receivables | 186 | 744 |
Inventory | 287 | 264 |
Contract assets | 0 | 99 |
Prepaid expenses and other assets | 391 | (547) |
Accounts payable | 1,101 | (125) |
Accrued sales allowances | (747) | 809 |
Other accrued liabilities | (200) | 30 |
Deferred revenue | 0 | (313) |
Net cash used in operating activities | (17,203) | (15,445) |
Cash flows from investing activities: | ||
Purchases of furniture and equipment | (540) | (256) |
Net cash used in investing activities | (540) | (256) |
Cash flows from financing activities: | ||
Proceeds from equity offerings | 11,636 | 9,665 |
Net loan proceeds | 654 | 0 |
Proceeds from the exercise of warrants | 7,243 | 1,603 |
Payments of long-term debt | (1,600) | 0 |
Net cash provided by financing activities | 17,933 | 11,268 |
Net increase (decrease) in cash | 190 | (4,433) |
Cash, cash equivalents and restricted cash at beginning of period | 5,223 | 9,656 |
Cash, cash equivalents and restricted cash at end of period | 5,413 | 5,223 |
Supplemental disclosure of cash flow information: | ||
Interest paid | 295 | 432 |
Purchases of property and equipment in accounts payable or accrued expenses | $ 0 | $ 11 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Organization and Summary of Significant Accounting Policies | |
Organization and Summary of Significant Accounting Policies | 1. Organization and Summary of Significant Accounting Policies The Company We are a pharmaceutical company developing therapeutics utilizing our proprietary long-term drug delivery platform, ProNeura (TM), for the treatment of select chronic diseases for which steady state delivery of a drug provides an efficacy and/or safety benefit. ProNeura consists of a small, solid implant made from a mixture of ethylene-vinyl acetate, or EVA, and a drug substance. The resulting product is a solid matrix that is administered subdermally, normally in the inner upper arm, in a brief, outpatient procedure and is removed in a similar manner at the end of the treatment period of several months. These procedures may be performed by trained health care providers, or HCPs, including licensed and surgically qualified physicians, nurse practitioners, and physician’s assistants in a HCP’s office or other clinical setting. Our first product based on our ProNeura technology was our Probuphine ® (buprenorphine) implant, which was approved in the United States, Canada and the European Union, or EU, for the maintenance treatment of opioid use disorder in clinically stable patients taking 8 mg or less a day of oral buprenorphine. Following reacquisition of the rights to Probuphine from our former licensee in mid-2018, we endeavored to build our infrastructure and grow our commercial capabilities with the limited resources at our disposal. While we made important progress in laying the groundwork during 2019 to transition into a company with full commercial potential, and also among other things manage the challenges of the restrictive product label, the Risk Evaluation and Mitigation Strategy, or REMS, program and the complexity of the distribution channel, the emergence of the Covid-19 pandemic in early 2020 and the resultant restrictions and lockdown of facilities severely impacted our ability to continue to expand our commercial operations. With limited financial resources and insufficient sales revenue during the first three quarters of 2020, we made the decision to discontinue selling Probuphine in the U.S. and wind down our commercialization activities, and to pursue a plan that will enable us to focus on our current, early-stage ProNeura-based product development programs. Probuphine continues to be commercialized in Canada and the EU by other companies who have either licensed or acquired the rights from Titan. We operate in only one business segment, the development of pharmaceutical products. In November 2020, pursuant to prior stockholder authorization, our board of directors, or the Board, effected a reverse split of the outstanding shares of our common stock at a ratio of one share for every thirty shares then outstanding, or the Reverse Split. Pursuant to their respective terms, the number of shares underlying our outstanding options and warrants was reduced and their respective exercise prices increased by the Reverse Split ratio. The number of shares of common stock authorized and the par value of $0.001 per share did not change as a result of the Reverse Split. All share and per share amounts contained in this Annual Report on Form 10-K give retroactive effect to the Reverse Split. The accompanying financial statements have been prepared assuming we will continue as a going concern. At December 31, 2020, we had cash and cash equivalents of approximately $5.4 million, which we believe, together with the net cash proceeds of approximately $8.9 million received from the registered direct offering of our common stock in January 2021, is sufficient to fund our planned operations into the first quarter of 2022. We will require additional funds to finance our operations. We are exploring several financing alternatives; however, there can be no assurance that our efforts to obtain the funding required to continue our operations will be successful. There is substantial doubt about our ability to continue as a going concern. Discontinued Operations In October 2020, we announced our decision to discontinue selling Probuphine in the U.S. and wind down our commercialization activities, and to pursue a plan that will enable us to focus on our current, early-stage ProNeura-based product development programs. The accompanying financial statements have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to our U.S. commercialization activities as discontinued operations (see Note 11). The accompanying financial statements are generally presented in conformity with our historical format We believe this format provides comparability with the previously filed financial statements. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. Going concern assessment We assess going concern uncertainty in our financial statements to determine if we have sufficient cash on hand and working capital, including available borrowings on loans, to operate for a period of at least one year from the date the financial statements are issued or available to be issued, which is referred to as the “look-forward period” as defined by Accounting Standard Update ASU No. 2014-15. As part of this assessment, based on conditions that are known and reasonably knowable to us, we will consider various scenarios, forecasts, projections, estimates and will make certain key assumptions, including the timing and nature of projected cash expenditures or programs, and its ability to delay or curtail expenditures or programs, if necessary, among other factors. Based on this assessment, as necessary or applicable, we make certain assumptions around implementing curtailments or delays in the nature and timing of programs and expenditures to the extent we deem probable those implementations can be achieved and we have the proper authority to execute them within the look-forward period in accordance with ASU No. 2014-15. Based upon the above assessment, we concluded that, at the date of filing the financial statements in this Annual Report on Form 10-K for the year ended December 31, 2020, we did not have sufficient cash to fund our operations for the next 12 months without additional funds and, therefore, there was substantial doubt about our ability to continue as a going concern within 12 months after the date the financial statements were issued. Additionally, we have suffered recurring losses from operations and have an accumulated deficit that raises substantial doubt about our ability to continue as a going concern. Inventories Inventories are recorded at the lower of cost or net realizable value. Cost is based on the first in, first out method. We regularly review inventory quantities on hand and write down to its net realizable value any inventory that we believe to be impaired. The determination of net realizable value requires judgment including consideration of many factors, such as estimates of future product demand, product net selling prices, current and future market conditions and potential product obsolescence, among others. The components of inventories are as follows: As of December 31, 2020 2019 Raw materials and supplies $ 170 $ 563 Finished goods 158 — $ 328 $ 563 The approximately $158,000 of finished goods inventory at December 31, 2020 included materials held for sale to Molteni and Knight. We had approximately $435,000 of finished goods inventory at December 31, 2019 which has been reclassified to discontinued operations. Stock-Based Compensation We recognize compensation expense using a fair-value based method, for all stock-based payments including stock options and restricted stock awards and stock issued under an employee stock purchase plan. These standards require companies to estimate the fair value of stock-based payment awards on the date of grant using an option pricing model. See Note 9 “Stock Plans,” for a discussion of our stock-based compensation plans. Warrants Issued in Connection with Equity Financing We generally account for warrants issued in connection with equity financings as a component of equity, unless there is a deemed possibility that we may have to settle the warrants in cash. For warrants issued with deemed possibility of cash settlement, we record the fair value of the issued warrants as a liability at each reporting period and record changes in the estimated fair value as a non-cash gain or loss in the Statements of Operations and Comprehensive Loss. Cash and Cash Equivalents Our investment policy emphasizes liquidity and preservation of principal over other portfolio considerations. We select investments that maximize interest income to the extent possible given these two constraints. We satisfy liquidity requirements by investing excess cash in securities with different maturities to match projected cash needs and limit concentration of credit risk by diversifying our investments among a variety of high credit-quality issuers and limit the amount of credit exposure to any one issuer. The estimated fair values have been determined using available market information. We do not use derivative financial instruments in our investment portfolio. All investments with original maturities of three months or less are considered to be cash equivalents. We had money market funds of approximately $5.1 million and $4.9 million as of December 31, 2020 and 2019, respectively, included in our cash and cash equivalents. Property and Equipment Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets ranging from three to five years. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the assets. Revenue Recognition We generate revenue principally from collaborative research and development arrangements, technology licenses and sales, government grants, sales of Probuphine materials to Molteni and Knight, and prior to the discontinued operations, the sale of Probuphine in the U.S. Consideration received for revenue arrangements with multiple components is allocated among the separate performance obligations based upon their relative estimated standalone selling price. In determining the appropriate amount of revenue to be recognized as we fulfill our obligations under our agreements, we perform the following steps for our revenue recognition: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) we satisfy each performance obligation. Net Product Revenue Prior to the discontinuation of our commercialization activities relate to Probuphine in the U.S., we recognized revenue from product sales when control of the product transfers, generally upon shipment or delivery, to our customers, which include distributors. As customary in the pharmaceutical industry, our gross product revenue was subject to a variety of deductions in the forms of variable consideration, such as rebates, chargebacks, returns and discounts, in arriving at reported net product revenue. This variable consideration was estimated using the most-likely amount method, which is the single most-likely outcome under a contract and was typically at stated contractual rates. The actual outcome of this variable consideration could materially differ from our estimates. From time to time, we would adjust our estimates of this variable consideration when trends or significant events indicated that a change in estimate is appropriate to reflect the actual experience. Additionally, we continued to assess the estimates of our variable consideration as we continued to accumulate additional historical data. Returns – Consistent with the provisions of ASC 606, we estimated returns at the inception of each transaction, based on multiple considerations, including historical sales, historical experience of actual customer returns, levels of inventory in our distribution channel, expiration dates of purchased products and significant market changes which could impact future expected returns to the extent that we would not reverse any receivables, revenues, or contract assets already recognized under the agreement. During the year ended December 31, 2019, we entered into agreements with large national specialty pharmacies with a distribution channel different from that of our existing customers and, therefore, the related reserves had unique considerations. We continued to evaluate the activities with these specialty pharmacies and updated the related reserves accordingly. Rebates – Our provision for rebates was estimated based on our customers’ contracted rebate programs and our historical experience of rebates paid. Discounts –The provision was estimated based upon invoice billings, utilizing historical customer payment experience. The following table provides a summary of activity with respect to our product returns and discounts and rebates, which have been reclassified to discontinued operations for all periods presented (in thousands): Accrued Sales Allowances Discounts and Allowance for Product Return Rebates Doubtful Allowance Allowance Total Accounts Balance at December 31, 2019 $ 721 $ 88 $ 809 $ 63 Provision 94 40 134 31 Payments/credits (759) (123) (882) (78) Balance at December 31, 2020 $ 56 $ 5 $ 61 $ 16 Performance Obligations A performance obligation is a promise in a contract to transfer a distinct good or service to the customer. Our performance obligations include commercialization license rights, development services and services associated with the regulatory approval process. We have optional additional items in contracts, which are accounted for as separate contracts when the customer elects such options. Arrangements that include a promise for future commercial product supply and optional research and development services at the customer’s discretion are generally considered as options. We assess if these options provide a material right to the customer and, if so, such material rights are accounted for as separate performance obligations. If we are entitled to additional payments when the customer exercises these options, any additional payments are recorded in revenue when the customer obtains control of the goods or services. Transaction Price We have both fixed and variable consideration. Non-refundable upfront payments are considered fixed, while milestone payments are identified as variable consideration when determining the transaction price. Funding of research and development activities is considered variable until such costs are reimbursed at which point they are considered fixed. We allocate the total transaction price to each performance obligation based on the relative estimated standalone selling prices of the promised goods or services for each performance obligation. At the inception of each arrangement that includes milestone payments, we evaluate whether the milestones are considered probable of being achieved and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone is included in the transaction price. Milestone payments that are not within our control, such as approvals from regulators, are not considered probable of being achieved until those approvals are received. For arrangements that include sales-based royalties or earn-out payments, including milestone payments based on the level of sales, and the license or purchase agreement is deemed to be the predominant item to which the royalties or earn-out payments relate, we recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty or earn-out payment has been allocated has been satisfied (or partially satisfied). Allocation of Consideration As part of the accounting for these arrangements, we must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the contract. Estimated selling prices for license rights are calculated using the residual approach. For all other performance obligations, we use a cost-plus margin approach. Timing of Recognition Significant management judgment is required to determine the level of effort required under an arrangement and the period over which we expect to complete our performance obligations under an arrangement. We estimate the performance period or measure of progress at the inception of the arrangement and re-evaluate it each reporting period. This re-evaluation may shorten or lengthen the period over which revenue is recognized. Changes to these estimates are recorded on a cumulative catch up basis. If we cannot reasonably estimate when our performance obligations either are completed or become inconsequential, then revenue recognition is deferred until we can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. Revenue is recognized for licenses or sales of functional intellectual property at the point in time the customer can use and benefit from the license. For performance obligations that are services, revenue is recognized over time proportionate to the costs that we have incurred to perform the services using the cost-to-cost input method. Research and Development Costs and Related Accrual Research and development expenses include internal and external costs. Internal costs include salaries and employment related expenses, facility costs, administrative expenses and allocations of corporate costs. External expenses consist of costs associated with outsourced contract research organization (“CRO”) activities, sponsored research studies, product registration, patent application and prosecution, and investigator sponsored trials. We also record accruals for estimated ongoing clinical trial costs. Clinical trial costs represent costs incurred by CROs and clinical sites. These costs are recorded as a component of research and development expenses. Under our agreements, progress payments are typically made to investigators, clinical sites and CROs. We analyze 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. Net Loss Per Share Basic net loss per share excludes the effect of dilution and is computed by dividing net loss by the weighted-average number of shares outstanding for the period. Diluted net loss per share reflects the potential dilution that could occur if securities or other contracts to issue shares were exercised into shares. In calculating diluted net loss per share, the numerator is adjusted for the change in the fair value of the warrant liability (only if dilutive) and the denominator is increased to include the number of potentially dilutive common shares assumed to be outstanding during the period using the treasury stock method. Basic and diluted net loss per share was the same for each of the periods presented. The table below presents common shares underlying stock options and warrants that are excluded from the calculation of the weighted average number of shares of common stock outstanding used for the calculation of diluted net loss per common share. These are excluded from the calculation due to their anti-dilutive effect for the years ended (in thousands): December 31, 2020 2019 Weighted-average anti-dilutive common shares resulting from stock awards 31 36 Weighted-average anti-dilutive common shares resulting from warrants 297 256 Convertible debt — 49 328 341 Leases In February 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standard Update, or ASU, No. 2016-02, Leases (Topic 842), to enhance the transparency and comparability of financial reporting related to leasing arrangements. We adopted the standard effective January 1, 2019. We determine whether the arrangement is or contains a lease at inception. Operating lease right-of-use assets and lease liabilities are recognized at the present value of the future lease payments at commencement date. The interest rate implicit in lease contracts is typically not readily determinable, and therefore, we utilize our incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received. Lease expense is recognized over the expected term on a straight-line basis. Operating leases are recognized on our balance sheet as right-of-use assets, operating lease liabilities current and operating lease liabilities non-current. We no longer recognize deferred rent on our balance sheet. The following table presents maturities of our operating lease as of December 31, 2020 (in thousands): 2021 155 Total minimum lease payments (base rent) 155 Less: imputed interest (5) Total operating lease liabilities $ 150 Subsequent Events We have evaluated events that have occurred subsequent to December 31, 2020 and through the date that the financial statements are issued. Fair Value Measurements We measure the fair value of financial assets and liabilities based on authoritative guidance which defines fair value, establishes a framework consisting of three levels for measuring fair value, and requires disclosures about fair value measurements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. There are three levels of inputs that may be used to measure fair value: Level 1 – quoted prices in active markets for identical assets or liabilities; Level 2 – quoted prices for similar assets and liabilities in active markets or inputs that are observable; Level 3 – inputs that are unobservable (for example cash flow modeling inputs based on assumptions). Financial instruments, including receivables, accounts payable and accrued liabilities are carried at cost, which we believe approximates fair value due to the short-term nature of these instruments. The approximately $5.1 million and $4.9 million fair values of money market funds as of December 31, 2020 and 2019 included in our cash and cash equivalents are classified as Level 1 and were derived from quoted market prices as active markets for these instruments exists. Our warrant and derivative liabilities are classified within level 3 of the fair value hierarchy because the value is calculated using significant judgment based on our own assumptions in the valuation of these liabilities. The following table presents a roll forward of the fair value of our warrant liability, the fair value of which is determined by Level 3 inputs for the years ended (in thousands): 2020 2019 Fair value, beginning of period $ 320 $ — Issuance of warrants 1,654 1,430 Change in fair value (1) 923 (1,110) Reclassification of warrants to additional paid-in capital (2,897) — Fair value, end of period $ — $ 320 (1) Recognized as non-cash loss on changes in fair value of warrants in the statement of operations and comprehensive loss. The following table presents a roll forward of the fair value of our derivative liability, the fair value of which is determined by Level 3 inputs for the years ended (in thousands): December 31, 2020 2019 Fair value, beginning of period $ — $ 25 Issuance of derivative — — Change in fair value — (25) Fair value, end of period $ — $ — Recent Accounting Pronouncements Accounting Standards Adopted In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement, which eliminates, adds and modifies certain disclosure requirements for fair value measurements as part of the FASB's disclosure framework project. We adopted ASU 2018-13 effective January 1, 2020 with no material impact to our financial statements and related disclosures. Accounting Standards Not Yet Adopted In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses, which requires an organization to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. Financial institutions and other organizations will now use forward-looking information to better inform their credit loss estimates. The amendments in this ASU are effective for us in our interim period ending March 31, 2023. We are currently assessing the impact of the adoption of Topic 326 on our financial statements and disclosures. In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform, which provides companies with optional guidance, including expedients and exceptions for applying generally accepted accounting principles to contracts and other transactions affected by reference rate reform, such as the London Interbank Offered Rate (LIBOR). This new standard was effective upon issuance and generally can be applied to applicable contract modifications through December 31, 2022. We are evaluating the effects that the adoption of this guidance will have on our financial statements and disclosures. In August 2020, the FASB issued ASU No. 2020-06, Accounting for Convertible Instruments and Contracts in an Entity's Own Equity, which simplifies the accounting for convertible instruments. ASU 2020-06 eliminates certain models that require separate accounting for embedded conversion features, in certain cases. Additionally, among other changes, the guidance eliminates certain of the conditions for equity classification for contracts in an entity’s own equity. The guidance also requires entities to use the if converted method for all convertible instruments in the diluted earnings per share calculation and include the effect of share settlement for instruments that may be settled in cash or shares, except for certain liability-classified share-based payment awards. This guidance is effective beginning after December 15, 2023 and must be applied using either a modified or full retrospective approach. Early adoption is permitted. We are currently evaluating the impact this guidance will have on our financial statements and related disclosures. |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2020 | |
Property and Equipment | |
Property and Equipment | 2. Property and Equipment Property and equipment consisted of the following (in thousands): As of December 31, 2020 2019 Furniture and office equipment $ 388 $ 388 Leasehold improvements 408 408 Laboratory equipment 1,108 3,413 Computer equipment 1,262 1,218 Construction in progress — 73 3,166 5,500 Less accumulated depreciation and amortization (2,548) (4,683) Property and equipment, net $ 618 $ 817 |
Molteni Purchase Agreement
Molteni Purchase Agreement | 12 Months Ended |
Dec. 31, 2020 | |
Molteni Purchase Agreement | |
Molteni Purchase Agreement | 3 . Molteni Purchase Agreement In March 2018, we entered into and in August 2018 amended an Asset Purchase, Supply and Support Agreement, or the Purchase Agreement, with L. Molteni & C. Dei Frattelli Alitti Societa Di Esercizio S.P.A., or Molteni, pursuant to which Molteni acquired the European intellectual property related to Probuphine and the exclusive right to commercialize Probuphine (which it renamed Sixmo) in Europe, as well as certain countries of the Commonwealth of Independent States, the Middle East and North Africa, or the Molteni Territory. We received an initial payment of €2.0 million ($2,448,000) for the purchased assets and an additional payment of €950,000 ($1,107,000) upon execution of the amendment. Additionally, Titan was entitled to receive earn-out payments for up to 15 years on net sales of Probuphine in the Molteni Territory. The Purchase Agreement also provided that Titan would supply Molteni with semi-finished product (i.e., the implant and the applicator) on an exclusive basis at a fixed price through December 31, 2019, with subsequent price increases not to exceed annual cost increases to Titan under its current manufacturing agreement and for the purchase of the active pharmaceutical ingredient. We concluded that the performance obligations identified in the Molteni Purchase Agreement included the transfer of the intellectual property and our efforts towards an approval by the EMA and other regulatory bodies. The initial payment was allocated between the property transfer and our EMA efforts as set forth below. We used the expected cost-plus approach to estimate the standalone selling price of approximately $1.4 million related to our efforts towards an approval by the EMA and other regulatory bodies (“Titan Services”). This includes employee related expenses as well as other manufacturing, regulatory and clinical costs, which are incurred as part of our efforts. We recognized revenue associated with Titan Services ratably over the estimated service period. As of March 31, 2019, we fully recognized the revenue associated with the Titan Services under the Molteni Purchase Agreement as we completed the Titan Services. We used the residual approach to value the transfer of the intellectual property at approximately $1.0 million as we had not established and had no reliable way to establish a standalone selling price for the intellectual property. As a result of the outcome of the milestone and earn-out payments being unpredictable due to the involvement of third parties, we believe that using the most likely amount method is appropriate. Any subsequent revenue related to milestone and earn-out payments will be recognized at the time the milestones are achieved or when the related net sales have occurred. The Molteni Purchase Agreement provides that we supply Molteni with semi-finished product (i.e., the implant, the applicator and related technology) on an exclusive basis at a fixed price through December 31, 2019, with subsequent price increases not to exceed annual cost increases to us for the active pharmaceutical ingredient and under our current manufacturing agreement. Revenue is recognized when the semi-finished product has been transferred to Molteni. Molteni will be prohibited from marketing a competitor product as defined in the Molteni Purchase Agreement in the Molteni Territory for the five year period following approval of the marketing authorization application. Thereafter, Molteni will be required to pay us a low single digit royalty on net sales of any competitor product. The following table presents changes in contract assets and liabilities during the year ended December 31, 2019 (in thousands): Beginning Ending Balance Additions Deductions Balance Year ended December 31, 2019 Contract assets $ 99 — (99) $ — Contract liabilities: Deferred revenue $ 313 — (313) $ — In August 2018, we entered into an amendment to the Molteni Purchase Agreement , pursuant to which Molteni made an immediate payment of €950,000 (approximately $1.1 million) and a convertible loan of €550,000 (approximately $0.6 million) (“Molteni Convertible Loan”) (see Note 7) to us, both in exchange for the elimination of an aggregate of €2.0 million (approximately $2.3 million) of regulatory milestones provided for in the Molteni Purchase Agreement. We concluded that the approximately $1.1 million immediate payment by Molteni reflected a milestone payment with no additional obligations to us and, therefore, was recognized as revenue during the year ended December 31, 2018. In September 2019, we entered into an additional amendment to the Molteni Purchase Agreement, pursuant to which the percentage earn-out payments on net sales was reduced from the original range of low-teens to mid-twenties to the current range of low-teens to mid-teens. We also agreed to delay payment of any earn-outs until the later of (i) January 1, 2021 or (ii) the one year anniversary of completion of compliance by our manufacturer with EU requirements (currently anticipated to occur during the second quarter of this year). The milestone payments under the Molteni Purchase Agreement remain unchanged. In October 2020, we entered into a Debt Settlement and Release Agreement (“DSRA Agreement”) with Molteni and Horizon Technology Finance Corporation (“Horizon”), the holders of our outstanding secured debt, to settle such obligations for $1.6 million in cash, the transfer of certain Probuphine assets to Molteni, including all of our manufacturing equipment, and the termination of our rights to future payments under the Purchase Agreement with Molteni. The DSRA Agreement, provided for the release to us of the remaining collateral. We recorded a loss of approximately $0.1 million related to the DSRA Agreement in the statements of operations and comprehensive loss for the period ended December 31, 2020. |
JT Pharmaceuticals Asset Purcha
JT Pharmaceuticals Asset Purchase Agreement | 12 Months Ended |
Dec. 31, 2020 | |
JT Pharmaceuticals Asset Purchase Agreement | |
JT Pharmaceuticals Asset Purchase Agreement | 4. JT Pharmaceuticals Asset Purchase Agreement In October 2020, we entered into an Asset Purchase Agreement (the “JT Agreement”) with JT Pharmaceuticals, Inc. (“JT Pharma”) to acquire JT Pharma’s kappa opioid agonist peptide, JT-09, for use in combination with our ProNeura long-term, continuous drug delivery technology, for the treatment of chronic pruritus and other medical conditions. Under the terms of the JT Agreement, JT Pharma received a $15,000 closing payment and is entitled to receive future milestone payments, payable in cash or in stock, based on the achievement of regulatory milestones, and single-digit percentage earn-out payments on net sales of the product if successfully developed and approved for commercialization. To date, none of these events have occurred and no contingent consideration, milestone or earn-out payments have been recognized. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 5. Commitments and Contingencies Lease Commitments We lease our office facility under operating lease that expires in June 2021. Rent expense associated with this lease was approximately $0.3 million each year for years ended December 31, 2020 and 2019, respectively. Minimum payments Our manufacturing agreement, as amended, with DPT, our contract manufacture, provides for a minimum manufacturing fee of $1.0 million. In the event we do not have DPT manufacture sufficient quantities of product to exceed the minimum manufacturing fee, DPT is able to invoice us for the amount of the shortfall. Guarantees and Indemnifications As permitted under Delaware law and in accordance with our Bylaws, we indemnify our officers and directors for certain events or occurrences while the officer or director is or was serving at our request in such capacity. The term of the indemnification period is for the officer’s or director’s lifetime. The maximum amount of potential future indemnification is unlimited; however, we have a director and officer insurance policy that limits our exposure and may enable us to recover a portion of any future amounts paid. We believe the fair value of these indemnification agreements is minimal. Accordingly, we have not recorded any liabilities for these agreements as of December 31, 2020. In the normal course of business, we have commitments to make certain milestone payments to various clinical research organizations in connection with our clinical trial activities. Payments are contingent upon the achievement of specific milestones or events as defined in the agreements, and we have made appropriate accruals in our financial statements for those milestones that were achieved as of December 31, 2020. We also provide indemnifications of varying scope to our CROs and investigators against claims made by third parties arising from the use of our products and processes in clinical trials. Historically, costs related to these indemnification provisions were immaterial. We also maintain various liability insurance policies that limit our exposure. We are unable to estimate the maximum potential impact of these indemnification provisions on our future results of operations. Legal Proceedings A legal proceeding has been initiated by a former employee alleging wrongful termination, retaliation, infliction of emotional distress, negligent supervision, hiring and retention and slander. An independent investigation into this individual’s allegations, while still an employee, was conducted utilizing an outside expert and concluded that such allegations were without merit. We intend to vigorously defend the lawsuit; however, in light of our cash position, there can be no assurance that the defense and/or settlement of this matter will not have a material adverse impact on our business. |
Warrant Liability
Warrant Liability | 12 Months Ended |
Dec. 31, 2020 | |
Warrant Liability | |
Warrant Liability | 6 . Warrant Liability March 2020 Warrant Amendment On March 3, 2020, we amended certain outstanding warrants to purchase an aggregate of 385,078 shares of common stock, including the January 2020 Warrants and warrants we issued in connection with a financing in August 2019 (the “August 2019 Warrants”), to modify certain provisions that had required them to be previously classified as liabilities and to enable them to now be classified as equity under the relevant accounting standards. As a result, we reclassified the fair value of the warrants on the date of the amendment from warrant liabilities to additional paid-in capital in the balance sheet and recognized a non-cash loss on changes in the fair value of warrants in the statement of operations and comprehensive loss. The following table provides a roll forward of the fair value of our warrant liabilities, the fair value of which was determined by Level 3 inputs for the year ended December 31, 2020 (in thousands): Fair value, December 31, 2019 $ 320 Issuance of the January 2020 Warrants 1,654 Change in fair value (1) 923 Reclassification of warrants to additional paid-in capital (2,897) Fair value, December 31, 2020 $ — (1) Recognized as non-cash loss on changes in fair value of warrants in the statement of operations and comprehensive loss. The warrant liability associated with the January 2020 Warrants was classified within Level 3 of the fair value hierarchy. The following table presents the weighted-average key assumptions used to calculate the fair value of the January 2020 Warrants: As of March 3, 2020 January 7, 2020 Expected volatility 124 % 121 % Risk-free interest rate 0.8 % 1.6 % Dividend yield — — Expected term (in years) 4.9 5.0 Weighted-average fair value per share warrant $ 7.80 $ 5.70 The warrant liability associated with the August 2019 Warrants was classified within Level 3 of the fair value hierarchy. The following table presents the weighted-average key assumptions used to calculate the fair value of the August 2019 Warrants: As of March 3, 2020 December 31, 2019 Expected volatility 124 % 125 % Risk-free interest rate 0.8 % 1.7 % Dividend yield — — Expected term (in years) 4.5 4.6 Weighted-average fair value per share warrant $ 6.30 $ 3.30 August 2019 Warrant Liability In August 2019, we completed a registered direct offering (the “August 2019 Offering”) and issued warrants to purchase 95,078 shares of our common stock with an exercise price of $32.10 per share (the “Placement Warrants”) in a concurrent private placement (see Note 6). The Placement Warrants agreement contained a provision where the warrant holder had the option to receive cash, equal to the Black Scholes fair value of the remaining unexercised portion of the warrant, as cash settlement in the event that there is a fundamental transaction (contractually defined to include various merger, acquisition or stock transfer activities). As a result of this provision, in accordance with ASC 480, “Distinguishing Liabilities from Equity,” the Placement Warrants were required to be classified as liabilities at the time of issuance. The fair value of the Placement Warrants was determined using the Black-Scholes Option Pricing model to calculate the call option and a Binomial Option Pricing model to calculate the put option with changes in the fair value recorded in our statements of operations and comprehensive loss. As of December 31, 2019, total fair value of the Placement Warrants was approximately $0.3 million, which is included within warrant liabilities in our balance sheet. The warrant liability associated with the Placement Warrants is classified within level 3 of the fair value hierarchy. The below table represents the weighted-average key assumptions used to calculate the fair value of the Placement Warrants: As of August 7, 2019 December 31, 2019 Expected volatility 87 % 125 % Risk-free interest rate 1.5 % 1.7 % Dividend yield — — Expected term (in years) 4.9 4.6 Weighted-average fair value per share warrant $ 15.00 $ 3.30 |
Debt Agreements
Debt Agreements | 12 Months Ended |
Dec. 31, 2020 | |
Debt Agreements | |
Debt Agreements | 7. Debt Agreements Horizon and Molteni Loan In July 2017, we entered into a venture loan and security agreement (the “Horizon Loan Agreement”) with Horizon Technology Finance Corporation (“Horizon”), which provided up to $10.0 million in loans, including an initial loan in the amount of $7.0 million funded upon signing of the Horizon Loan Agreement. In connection with the Horizon Loan Agreement, we issued Horizon seven-year warrants to purchase common stock (the “Horizon Warrants”). The Horizon Warrants were classified as equity and the fair value of the Horizon Warrants at the time of issuance was determined using a Lattice valuation model. Our obligations under the Loan Agreement are secured by a first priority security interest in all of our assets, with the exception of our intellectual property. We agreed not to pledge or otherwise encumber our intellectual property assets, subject to certain exceptions. In February 2018, we entered into an amendment to the Original Loan Agreement (the “Amended Loan Agreement”) pursuant to which we prepaid $3.0 million of the outstanding $7.0 million principal amount and provided Horizon with a lien on our intellectual property. In March 2018, we entered into an Amended and Restated Venture Loan and Security Agreement (the “Restated Loan Agreement”) with Horizon and Molteni pursuant to which Horizon assigned approximately $2.4 million of the $4.0 million outstanding principal balance of the loan to Molteni and Molteni was appointed as the collateral agent and assumed majority and administrative control of the loan. Under the Restated Loan Agreement, Molteni had the right to convert its portion of the debt into shares of our common stock at a conversion price of $216.00 per share and was required to effect this conversion of debt to equity if we complete an equity financing resulting in gross proceeds of at least $10.0 million at a price per share of common stock in excess of $216.00 and repay the $1.6 million balance of Horizon’s loan amount. In connection with the Restated Loan Agreement, we issued additional warrants to purchase an aggregate of 223 shares of our common stock with an exercise price per share of $216.00 to Horizon (collectively, the “Horizon Warrants”). These warrants were classified as equity and the key assumptions used to value these warrants as of the date of the issuance were as follows: Expected price volatility 86 % Expected term (in years) 7.0 Risk-free interest rate 2.8 % Dividend yield 0.0 % Weighted-average fair value per share warrant $ 145.80 In consideration of Molteni’s entry into the Horizon Loan Agreement and the Molteni Purchase Agreement (see Note 3), in March 2018, we entered into a rights agreement (the “Rights Agreement”) with Molteni pursuant to which we agreed to (i) issue Molteni seven-year warrants to purchase 3,000 shares of our common stock at an exercise price of $216.00 per share (the “Molteni Warrants”), (ii) provide Molteni customary demand and piggy-back registration rights with respect to the shares of common stock issuable upon conversion of its loan and exercise of the Molteni Warrants, (iii) designate one member of our board of directors following conversion of the loan in full and (iv) provide board observer rights to Molteni if it has not designated a board nominee as well as certain information rights. The board designation, observer and information rights will terminate at such time as Molteni ceases to beneficially own at least one percent of our outstanding capital stock (inclusive of the shares issuable upon conversion of debt under the Restated Loan Agreement and exercise of the Molteni Warrants). The Molteni Warrants have been classified as equity and their fair value at the time of issuance was determined using a Black Scholes valuation model. The amount was allocated equally between the Restated Loan Agreement and the Purchase Agreement and was recorded in the Balance Sheets as a discount to the Molteni loan and a contract asset, respectively. The key assumptions used to value the Molteni Warrants were as follows: Expected price volatility 86 % Expected term (in years) 7.0 Risk-free interest rate 2.8 % Dividend yield 0.0 % Weighted-average fair value of warrants $ 145.80 Repayment of the loans was on an interest-only basis, followed by monthly payments of principal and accrued interest for the balance of the 46‑month term. The loans bear interest at a floating coupon rate of one-month LIBOR (floor of 1.10%) plus 8.40%. A final payment equal to 5.0% of each loan tranche will be due on the scheduled maturity date for such loan. In addition, if we repay all or a portion of the loan prior to the applicable maturity date, we will pay Horizon and Molteni prepayment penalty fees. In connection with our equity offering in September 2018, the Horizon Warrants to purchase 12,223 shares of our common stock at $45.00 per share became exercisable. In accordance with the guidance in ASU 2017-11, we recognized the effect of triggering the down round feature as a dividend in our balance sheets at December 31, 2018 and as an addition to net loss attributable to common stockholders and in our calculation of basic and fully diluted earnings per share in our statements of operations and comprehensive loss for the year ended December 31, 2018. We calculated the dividend of approximately $0.3 million resulting from the trigger of the down round provision in September 2018 using the Black Scholes Option Pricing Model and the assumptions indicated in the table below: Pre-reset Post-reset Exercise price per share $ 352.80 $ 45.00 Expected price volatility 71 % 71 % Expected term (in years) Risk-free interest rate 3.0 % 3.0 % Dividend yield 0.0 % 0.0 % Weighted-average fair value of warrants $ 9.00 $ 25.20 In September 2019, we entered into an amendment to the Restated Loan Agreement pursuant to which the interest-only payment and forbearance periods were extended by one year to December 31, 2020 and the maturity date was extended by one year to June 1, 2022. In connection with the amendment to the Restated Loan Agreement (as clarified by a second amendment in March 2020), the final payments to the lenders were increased by an aggregate of approximately $0.3 million (exclusive of a restructuring fee payable to Horizon) and the conversion provisions related to Molteni’s portion of the loan amount were revised to eliminate the mandatory conversion feature, to reduce the conversion price to $6.75 and to cap the number of shares issuable upon conversion to 114,093. In accordance with ASC 470, Debt, the amendment to the loan from Molteni is accounted for under debt extinguishment accounting, which required us to extinguish the carrying amount of the loan prior to the amendment and reacquire the loan after the amendment. As a result, during the year ended December 31, 2019, we recorded approximately $0.3 million gain on debt extinguishment related to the write-off of the balance of the accreted final payment of the loan. The modification to the loan from Horizon did not constitute debt extinguishment and, therefore, did not have any impact to our financial statements. In October 2020, we entered into the DSRA Agreement with Molteni and Horizon to settle our obligations for $1.6 million in cash, the transfer of certain Probuphine assets to Molteni, including all of our manufacturing equipment, and the termination of our rights to future payments under the Purchase Agreement with Molteni. The DSRA Agreement, provided for the release to us of the remaining collateral. As a result, during the year ended December 31, 2020, we recorded an approximately $0.1 million loss on debt extinguishment. Molteni Convertible Loan Due to the conversion provision of the Molteni Convertible Loan, ASC 815, Derivatives and Hedging required us to classify the conversion provision as an embedded derivative with changes in the fair value recorded in the statements of operations and comprehensive loss. The key assumptions used to value the Convertible Loan embedded derivative were as follows: As of September 18, 2018 December 31, 2018 Expected volatility 87 % 135 % Expected term (in years) 0.75 0.50 Risk-free interest rate 2.32 % 2.51 % Dividend yield — — Fair value of conversion provision (in thousands) $ 159 $ 25 In connection with the amendment to the Molteni Purchase Agreement (see Note 3), in June 2019, the Molteni Convertible Loan, together with unpaid accrued interest, was converted in full into 14,943 shares of our common stock at $45.00 per share upon the receipt of EMA approval of Sixmo. As a result, we recorded approximately $0.1 million loss on debt extinguishment. Paycheck Protection Program Loan On April 20, 2020, we received an approximately $654,000 loan ("PPP Loan") pursuant to the Paycheck Protection Program of the CARES Act. The PPP Loan matures in April 2022 with an annual interest rate of 1.0%. The PPP Loan originally had a six month deferral of payments period which was extended to sixteen months during the third quarter of 2020 and may be prepaid at any time without penalty. All other terms remained the same. Forgiveness of the loan, when requested, is not automatic and is only available for principal that is used for the limited purposes that expressly qualify for forgiveness under SBA requirements. The proceeds of the PPP Loan are to be used to retain workers and maintain payroll and make mortgage interest, lease and utility payments. A loan forgiveness application was submitted in December 2020. Approximately $0.3 million of the PPP loan is included in current portion of long-term debt and approximately $0.3 million is included in long- term debt on our balance sheet at December 31, 2020. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2020 | |
Stockholders' Equity | |
Stockholders' Equity | 8. Stockholders’ Equity Common Stock October 2020 Public Offering In October 2020, we completed the 2020 Public Offering pursuant to which we sold 2,666,667 units at a price of $3.00 per unit, with each unit consisting of (i) one share of common stock and (ii) one warrant (the "October 2020 Warrants") to purchase one share of common stock, resulting in gross proceeds of approximately $8.0 million. The net proceeds of the 2020 Public Offering, after deduction of underwriting discounts and commissions and other offering expenses and the $1.6 million payment pursuant to the DSRA Agreement, were approximately $5.7 million. The October 2020 Warrants have an exercise price of $3.00, were exercisable on December 1, 2020 following the reverse split of our common stock, and will expire on the fifth anniversary of the initial exercise date. September 2020 Offering In September 2020, we completed a registered direct offering with several institutional investors pursuant to which we issued 648,000 shares of our common stock at a price of $4.20 per share. We received net cash proceeds of approximately $2.4 million, after deduction of underwriting fees and other offering expenses. January 2020 Offering In January 2020, we completed a financing with several institutional investors pursuant to which we issued 290,000 shares of our common stock in a registered direct offering and warrants to purchase 290,000 shares of our common stock with an exercise price of $7.50 per share in a concurrent private placement (the "January 2020 Warrants") pursuant to which we received net cash proceeds of approximately $1.9 million, after deduction of underwriting fees and other offering expenses. The January 2020 Warrants became exercisable in September 2020 following receipt of stockholder approval of an increase in our authorized shares of common stock and they expire in July 2025. Financing costs of approximately $0.2 million allocated to the January 2020 warrant liability were expensed and included in other income (expense) in the statements of operations and comprehensive loss. October 2019 Public Offering In October 2019, we completed an underwritten public offering pursuant to which we issued 1,342,534 units at an offering price of $6.75 per unit, consisting of 1,196,200 shares of our common stock and pre-funded warrants to purchase 146,334 shares of our common stock with an exercise price of $0.30 per share, and class B warrants to purchase 1,342,534 shares of our common stock at $6.75 per share (the “Class B Warrants”). The pre-funded warrants, which were exercised for common stock in October 2019, were issued in lieu of common stock in order to ensure the investor did not exceed certain beneficial ownership limitations. The Class B Warrants are immediately exercisable and will expire in October 2024. The Class B Warrant agreement contains a provision where the warrant holder has the option to receive cash equal to the Black Scholes fair value of the remaining unexercised portion of the Class B Warrant only in the event that there is a fundamental transaction approved by the Board (contractually defined to include various merger, acquisition or stock transfer activities). The Class B Warrants issued in connection with the October 2019 public offering were classified as equity. August 2019 Offering In August 2019, we completed an offering with a single accredited institutional investor pursuant to which we issued 49,334 shares of our common stock and pre-funded warrants to purchase 45,744 shares of our common stock with an exercise price of $0.30 per share in a registered direct offering and the Placement Warrants to purchase 95,078 shares of our common stock with an exercise price of $32.10 per share in a concurrent private placement. The pre-funded warrants, which were exercised for common stock in September 2019, were issued in lieu of common stock in order to ensure the investor did not exceed certain beneficial ownership limitations. The Placement Warrants became exercisable in February 2020 and will expire in February 2025. At the time of issuance, the Placement Warrants contained a provision where the warrant holder has the option to receive cash, equal to the Black Scholes fair value of the remaining unexercised portion of the warrant, as cash settlement in the event that there is a fundamental transaction (contractually defined to include various merger, acquisition or stock transfer activities). The Placement Warrants were classified as a liability in the balance sheet at December 31, 2019. In March 2020, we amended the warrants to modify the provisions that had required them to be previously classified as liabilities and enabled them to be classified as equity under the relevant accounting standards (see Note 6). At-the-Market Offering (the “ATM”) In April 2019, we implemented the ATM for the sale of up to $8.6 million of our common stock. During the year ended December 31, 2019, we issued a total of 10,989 shares of our common stock at a weighted-average price of $48.00 per share for total net proceeds of approximately $0.5 million under the ATM. In August 2019 and January 2020, we reduced the dollar amount that can be sold under ATM to $4.0 million and $0.8 million, respectively. Common Stock Warrants During the year ended December 31, 2020, we received an aggregate of approximately $7.2 million in cash proceeds from the exercises of warrants to purchase 1,112,313 shares of our common stock. During the year ended December 31, 2020, we issued 450,761 shares of our common stock upon the cashless exercise of 1,022,408 warrants. As of December 31, 2020, the following warrants to purchase shares of our common stock were outstanding (in thousands, except per share price): Date Issued Expiration Date Exercise Price Outstanding 07/27/2017 07/27/2024 $ 45.00 12 03/21/2018 03/21/2025 $ 216.00 1 03/21/2018 03/21/2025 $ 216.00 3 09/25/2018 09/25/2023 $ 18.00 154 09/25/2018 09/25/2023 $ 50.40 8 08/09/2019 02/09/2025 $ 32.10 95 10/18/2019 10/18/2024 $ 3.00 230 01/09/2020 07/09/2025 $ 7.50 290 10/30/2020 12/01/2025 $ 3.00 1,644 2,437 Shares Reserved for Future Issuance As of December 31, 2020, shares of common stock reserved by us for future issuance consisted of the following (in thousands): Stock options outstanding 28 Shares issuable upon the exercise of warrants 2,437 2,465 |
Stock Plans
Stock Plans | 12 Months Ended |
Dec. 31, 2020 | |
Stock Plans | |
Stock Plans | 9. Stock Plans In August 2015, our stockholders approved the 2015 Omnibus Equity Incentive Plan (the “2015 Plan”). The 2015 Plan, as subsequently amended, authorized a total of 55,556 shares of our common stock for issuance to employees, directors, officers, consultants and advisors. As of December 31, 2020, options to purchase 30,786 shares of our common stock were available for grant and 24,770 shares of our common stock outstanding under the 2015 Plan. In January 2021, our stockholders approved an amendment to the 2015 Plan to increase the number of authorized shares to 1,000,000 shares. In February 2014, our Board adopted the 2014 Incentive Plan (the “2014 Plan”), pursuant to which 2,526 shares of our common stock were authorized for issuance to employees, directors, officers, consultants and advisors. The 2014 Plan was terminated upon the approval of the 2015 Plan. As of December 31, 2020, options to purchase 1,285 shares of our common stock were outstanding under the 2014 Plan. In July 2002, we adopted the 2002 Stock Incentive Plan (the “2002 Plan”). The 2002 Plan, as amended in 2005, authorized a total of approximately 7,234 shares of our common stock for issuance to employees, officers, directors, consultants, and advisers. The exercise prices of options granted under the 2002 Plan were 100% of the fair market value of our common stock on the date of grant. The 2002 Plan expired by its terms in July 2012. As of December 31, 2020, options to purchase an aggregate of 1,426 shares of our common stock were outstanding under the 2002 Plan. In August 2001, we adopted the 2001 Employee Non-Qualified Stock Option Plan (the “2001 NQ Plan”) pursuant to which 1,768 shares of common stock were authorized for issuance for option grants to employees and consultants who are not officers or directors of Titan. The exercise prices of options granted under the 2001 NQ Plan were 100% of the fair market value of our common stock on the date of grant. The 2001 Stock Option Plan expired by its terms in August 2011. As of December 31, 2020, options to purchase an aggregate of 412 shares of our common stock were outstanding under the 2001 NQ Plan. In January 2019, our stockholders approved a repricing of 4,071 fully-vested stock options with exercise prices in excess of $630.00 held by employees and consultants other than the named executive officers or members of the Board. The effected options were repriced at $46.50. As a result of the repricing of these stock options, we incurred a total of approximately $81,000 of additional stock-based compensation expense during the year ended December 31, 2019, of which approximately $54,000 was recorded within research and development and approximately $27,000 within selling, general and administrative in our statement of operations and comprehensive loss. The following table summarizes option activity for the year ended December 31, 2020: Weighted Weighted Average Average Aggregate Exercise Remaining Intrinsic Shares Price per Contractual Value (in thousands) Share Term (years) (in thousands) Outstanding at January 1, 2020 40 $ 187.09 7.85 $ — Granted 2 7.95 Cancelled/expired (14) 49.76 Outstanding at December 31, 2020 28 $ 242.70 6.35 $ — Exercisable at December 31, 2020 27 $ 247.27 6.29 $ — We use the Black-Scholes-Merton option-pricing model with the following assumptions to estimate the stock-based compensation expense: Years Ended December 31, 2020 2019 Weighted-average risk-free interest rate 0.4 % 2.21 % Expected dividend payments — — Expected holding period (years)(1) Weighted-average volatility factor(2) 1.04 0.94 Estimated forfeiture rates for options granted 27 % 21 % (1) Expected holding period is based on historical experience of similar awards, giving consideration to the contractual terms of the stock-based awards, vesting schedules and the expectations of future employee behavior. (2) Weighted average volatility is based on the historical volatility of our common stock. (3) Based upon the above methodology, the weighted-average fair value of options and awards granted during the years ended December 31, 2020 and 2019 was $6.30 and $49.20, respectively. The following table summarizes the stock-based compensation expense (in thousands): Years Ended December 31, 2020 2019 Research and development $ — $ 91 General and administrative 7 481 Total stock-based compensation expenses $ 7 $ 572 As of December 31, 2020, there was approximately $5,500 of total unrecognized compensation expense related to non-vested stock options. This expense is expected to be recognized over a weighted-average period of 1.4 years. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Taxes | |
Income Taxes | 10. Income Taxes As of December 31, 2020, we had federal net operating loss carryforwards of approximately $227.0 million that expire at various dates through 2037 and approximately $41.8 million which do not expire but are subject to 80% taxable income limitations. As of December 31, 2020, we had federal research and development tax credits of approximately $8.0 million that expire at various dates through 2040. We also had net operating loss carryforwards for California income tax purposes of approximately $109.7 million that expire at various dates through 2040 and state research and development tax credits of approximately $9.2 million which do not expire. Current federal and California tax laws include substantial restrictions on the utilization of net operating losses and tax credits in the event of an ownership change of a corporation under Internal Revenue Code Section 382 and 383. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes and operating loss and credit carryforwards. Significant components of our deferred tax assets are as follows (in thousands): As of December 31, 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 64,120 $ 63,910 Research credit carryforwards 15,228 15,683 Other, net 1,005 1,303 Total deferred tax assets 80,353 80,896 Deferred tax liabilities: Other, net (31) (84) Total deferred tax liabilities (31) (84) Valuation allowance (80,322) (80,812) Net deferred tax assets $ — $ — ASC 740 requires that the tax benefit of net operating losses, temporary differences and credit carryforwards be recorded as an asset to the extent that management assesses that realization is "more likely than not." Realization of the future tax benefits is dependent on our ability to generate sufficient taxable income within the carryforward period. Because of our recent history of operating losses, our management believes that recognition of the deferred tax assets arising from the above-mentioned future tax benefits is currently not likely to be realized and, accordingly, has provided a valuation allowance. Realization of deferred tax assets is dependent upon future earnings, if any, the timing and amount of which are uncertain. Accordingly, the net deferred tax assets have been fully offset by a valuation allowance. The valuation allowance decreased by approximately $0.5 million during 2020 and increased by approximately $0.7 million during 2019. The provision for income taxes consists of state minimum taxes due. The effective tax rate of our provision (benefit) for income taxes differs from the federal statutory rate as follows (in thousands): Years Ended December 31, 2020 2019 Computed at 21% $ (3,830) $ (3,451) State taxes (220) (146) Change in valuation allowance (491) 768 Other 26 56 Revaluation of warrant liability 194 (238) Research and development credits (65) (54) Tax attributes expirations 4,352 2,698 Impact of IRC 162m 34 367 Total $ — $ — We had no unrecognized tax benefits or any amounts accrued for interest and penalties for the three years ended December 31, 2020. Our policy is to recognize interest and penalties related to income taxes as a component of income tax expense. We do not expect the amount of unrecognized tax benefits will materially change in the next twelve months. We file tax returns in the U.S. federal jurisdiction and various state jurisdictions. We are subject to the U.S. federal and state income tax examination by tax authorities for such years 2001 through 2020, due to net operating losses that are being carried forward for tax purposes. |
Discontinued Operations
Discontinued Operations | 12 Months Ended |
Dec. 31, 2020 | |
Discontinued Operations | |
Discontinued Operations | 11.Discontinued Operations The components of loss from discontinued operations as reported in our statements of operations were as follows: Years ended December 31, 2020 2019 (In thousands, except per share data) Revenue: Product revenue $ 376 $ 1,006 Costs and expenses: Cost of goods sold 1,332 1,288 Research and development 1,917 2,162 Selling, general and administrative 7,224 6,524 Total costs and expenses 10,473 9,974 Loss from discontinued operations (10,097) (8,968) Other expense, net 738 — Net loss from discontinued operations $ 10,835 $ (8,968) Basic and diluted net loss per common share from discontinued operations $ (2.87) $ (11.71) Weighted average shares used in computing basic and diluted net loss per common share 3,773 766 The following table presents information related to assets and liabilities reported as discontinued operations in our balance sheet: December 31, 2020 2019 (In thousands) Receivables $ — $ 555 Inventory — 435 Prepaid expenses and other current assets 181 560 Discontinued operations – current assets $ 181 $ 1,550 Accounts payable $ 1,515 $ 585 Accrued clinical trials expenses 80 140 Accrued sales allowances 61 809 Other accrued liabilities 304 546 Discontinued operations – current liabilities $ 1,960 $ 2,080 During both years ended December 31, 2020 and 2019 we recognized non-cash stock-based compensation expenses of approximately $0.1 million which is included in discontinued operations. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2020 | |
Subsequent Events | |
Subsequent Events | 12. Subsequent Events Annual Meeting of Stockholders In January 2021, our stockholders approved an amendment to the 2015 Omnibus Equity Incentive plan to increase the number of authorized shares to 1,000,000 shares. January 2021 Offering In January 2021, we completed an offering with several accredited institutional investors pursuant to which we issued 2,725,000 shares of our common stock in a registered direct offering and warrants to purchase 2,725,000 shares of our common stock with an exercise price of $3.55 per share in a concurrent private placement. The warrants were exercisable immediately and will expire in July 2026. The net cash proceeds from this offering were approximately $8.9 million after deduction of underwriting fees and other offering expenses. |
Organization and Summary of S_2
Organization and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Organization and Summary of Significant Accounting Policies | |
The Company | The Company We are a pharmaceutical company developing therapeutics utilizing our proprietary long-term drug delivery platform, ProNeura (TM), for the treatment of select chronic diseases for which steady state delivery of a drug provides an efficacy and/or safety benefit. ProNeura consists of a small, solid implant made from a mixture of ethylene-vinyl acetate, or EVA, and a drug substance. The resulting product is a solid matrix that is administered subdermally, normally in the inner upper arm, in a brief, outpatient procedure and is removed in a similar manner at the end of the treatment period of several months. These procedures may be performed by trained health care providers, or HCPs, including licensed and surgically qualified physicians, nurse practitioners, and physician’s assistants in a HCP’s office or other clinical setting. Our first product based on our ProNeura technology was our Probuphine ® (buprenorphine) implant, which was approved in the United States, Canada and the European Union, or EU, for the maintenance treatment of opioid use disorder in clinically stable patients taking 8 mg or less a day of oral buprenorphine. Following reacquisition of the rights to Probuphine from our former licensee in mid-2018, we endeavored to build our infrastructure and grow our commercial capabilities with the limited resources at our disposal. While we made important progress in laying the groundwork during 2019 to transition into a company with full commercial potential, and also among other things manage the challenges of the restrictive product label, the Risk Evaluation and Mitigation Strategy, or REMS, program and the complexity of the distribution channel, the emergence of the Covid-19 pandemic in early 2020 and the resultant restrictions and lockdown of facilities severely impacted our ability to continue to expand our commercial operations. With limited financial resources and insufficient sales revenue during the first three quarters of 2020, we made the decision to discontinue selling Probuphine in the U.S. and wind down our commercialization activities, and to pursue a plan that will enable us to focus on our current, early-stage ProNeura-based product development programs. Probuphine continues to be commercialized in Canada and the EU by other companies who have either licensed or acquired the rights from Titan. We operate in only one business segment, the development of pharmaceutical products. In November 2020, pursuant to prior stockholder authorization, our board of directors, or the Board, effected a reverse split of the outstanding shares of our common stock at a ratio of one share for every thirty shares then outstanding, or the Reverse Split. Pursuant to their respective terms, the number of shares underlying our outstanding options and warrants was reduced and their respective exercise prices increased by the Reverse Split ratio. The number of shares of common stock authorized and the par value of $0.001 per share did not change as a result of the Reverse Split. All share and per share amounts contained in this Annual Report on Form 10-K give retroactive effect to the Reverse Split. The accompanying financial statements have been prepared assuming we will continue as a going concern. At December 31, 2020, we had cash and cash equivalents of approximately $5.4 million, which we believe, together with the net cash proceeds of approximately $8.9 million received from the registered direct offering of our common stock in January 2021, is sufficient to fund our planned operations into the first quarter of 2022. We will require additional funds to finance our operations. We are exploring several financing alternatives; however, there can be no assurance that our efforts to obtain the funding required to continue our operations will be successful. There is substantial doubt about our ability to continue as a going concern. |
Discontinued Operations | Discontinued Operations In October 2020, we announced our decision to discontinue selling Probuphine in the U.S. and wind down our commercialization activities, and to pursue a plan that will enable us to focus on our current, early-stage ProNeura-based product development programs. The accompanying financial statements have been recast for all periods presented to reflect the assets, liabilities, revenue and expenses related to our U.S. commercialization activities as discontinued operations (see Note 11). The accompanying financial statements are generally presented in conformity with our historical format We believe this format provides comparability with the previously filed financial statements. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the U.S. requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. |
Going concern assessment | Going concern assessment We assess going concern uncertainty in our financial statements to determine if we have sufficient cash on hand and working capital, including available borrowings on loans, to operate for a period of at least one year from the date the financial statements are issued or available to be issued, which is referred to as the “look-forward period” as defined by Accounting Standard Update ASU No. 2014-15. As part of this assessment, based on conditions that are known and reasonably knowable to us, we will consider various scenarios, forecasts, projections, estimates and will make certain key assumptions, including the timing and nature of projected cash expenditures or programs, and its ability to delay or curtail expenditures or programs, if necessary, among other factors. Based on this assessment, as necessary or applicable, we make certain assumptions around implementing curtailments or delays in the nature and timing of programs and expenditures to the extent we deem probable those implementations can be achieved and we have the proper authority to execute them within the look-forward period in accordance with ASU No. 2014-15. Based upon the above assessment, we concluded that, at the date of filing the financial statements in this Annual Report on Form 10-K for the year ended December 31, 2020, we did not have sufficient cash to fund our operations for the next 12 months without additional funds and, therefore, there was substantial doubt about our ability to continue as a going concern within 12 months after the date the financial statements were issued. Additionally, we have suffered recurring losses from operations and have an accumulated deficit that raises substantial doubt about our ability to continue as a going concern. |
Inventories | Inventories Inventories are recorded at the lower of cost or net realizable value. Cost is based on the first in, first out method. We regularly review inventory quantities on hand and write down to its net realizable value any inventory that we believe to be impaired. The determination of net realizable value requires judgment including consideration of many factors, such as estimates of future product demand, product net selling prices, current and future market conditions and potential product obsolescence, among others. The components of inventories are as follows: As of December 31, 2020 2019 Raw materials and supplies $ 170 $ 563 Finished goods 158 — $ 328 $ 563 The approximately $158,000 of finished goods inventory at December 31, 2020 included materials held for sale to Molteni and Knight. We had approximately $435,000 of finished goods inventory at December 31, 2019 which has been reclassified to discontinued operations. |
Stock-Based Compensation | Stock-Based Compensation We recognize compensation expense using a fair-value based method, for all stock-based payments including stock options and restricted stock awards and stock issued under an employee stock purchase plan. These standards require companies to estimate the fair value of stock-based payment awards on the date of grant using an option pricing model. See Note 9 “Stock Plans,” for a discussion of our stock-based compensation plans. |
Warrants Issued in Connection with Equity Financing | Warrants Issued in Connection with Equity Financing We generally account for warrants issued in connection with equity financings as a component of equity, unless there is a deemed possibility that we may have to settle the warrants in cash. For warrants issued with deemed possibility of cash settlement, we record the fair value of the issued warrants as a liability at each reporting period and record changes in the estimated fair value as a non-cash gain or loss in the Statements of Operations and Comprehensive Loss. |
Cash and Cash Equivalents | Cash and Cash Equivalents Our investment policy emphasizes liquidity and preservation of principal over other portfolio considerations. We select investments that maximize interest income to the extent possible given these two constraints. We satisfy liquidity requirements by investing excess cash in securities with different maturities to match projected cash needs and limit concentration of credit risk by diversifying our investments among a variety of high credit-quality issuers and limit the amount of credit exposure to any one issuer. The estimated fair values have been determined using available market information. We do not use derivative financial instruments in our investment portfolio. All investments with original maturities of three months or less are considered to be cash equivalents. We had money market funds of approximately $5.1 million and $4.9 million as of December 31, 2020 and 2019, respectively, included in our cash and cash equivalents. |
Property and Equipment | Property and Equipment Property and equipment are recorded at cost and depreciated using the straight-line method over the estimated useful lives of the assets ranging from three to five years. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the assets. |
Revenue Recognition | Revenue Recognition We generate revenue principally from collaborative research and development arrangements, technology licenses and sales, government grants, sales of Probuphine materials to Molteni and Knight, and prior to the discontinued operations, the sale of Probuphine in the U.S. Consideration received for revenue arrangements with multiple components is allocated among the separate performance obligations based upon their relative estimated standalone selling price. In determining the appropriate amount of revenue to be recognized as we fulfill our obligations under our agreements, we perform the following steps for our revenue recognition: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) we satisfy each performance obligation. Net Product Revenue Prior to the discontinuation of our commercialization activities relate to Probuphine in the U.S., we recognized revenue from product sales when control of the product transfers, generally upon shipment or delivery, to our customers, which include distributors. As customary in the pharmaceutical industry, our gross product revenue was subject to a variety of deductions in the forms of variable consideration, such as rebates, chargebacks, returns and discounts, in arriving at reported net product revenue. This variable consideration was estimated using the most-likely amount method, which is the single most-likely outcome under a contract and was typically at stated contractual rates. The actual outcome of this variable consideration could materially differ from our estimates. From time to time, we would adjust our estimates of this variable consideration when trends or significant events indicated that a change in estimate is appropriate to reflect the actual experience. Additionally, we continued to assess the estimates of our variable consideration as we continued to accumulate additional historical data. Returns – Consistent with the provisions of ASC 606, we estimated returns at the inception of each transaction, based on multiple considerations, including historical sales, historical experience of actual customer returns, levels of inventory in our distribution channel, expiration dates of purchased products and significant market changes which could impact future expected returns to the extent that we would not reverse any receivables, revenues, or contract assets already recognized under the agreement. During the year ended December 31, 2019, we entered into agreements with large national specialty pharmacies with a distribution channel different from that of our existing customers and, therefore, the related reserves had unique considerations. We continued to evaluate the activities with these specialty pharmacies and updated the related reserves accordingly. Rebates – Our provision for rebates was estimated based on our customers’ contracted rebate programs and our historical experience of rebates paid. Discounts –The provision was estimated based upon invoice billings, utilizing historical customer payment experience. The following table provides a summary of activity with respect to our product returns and discounts and rebates, which have been reclassified to discontinued operations for all periods presented (in thousands): Accrued Sales Allowances Discounts and Allowance for Product Return Rebates Doubtful Allowance Allowance Total Accounts Balance at December 31, 2019 $ 721 $ 88 $ 809 $ 63 Provision 94 40 134 31 Payments/credits (759) (123) (882) (78) Balance at December 31, 2020 $ 56 $ 5 $ 61 $ 16 Performance Obligations A performance obligation is a promise in a contract to transfer a distinct good or service to the customer. Our performance obligations include commercialization license rights, development services and services associated with the regulatory approval process. We have optional additional items in contracts, which are accounted for as separate contracts when the customer elects such options. Arrangements that include a promise for future commercial product supply and optional research and development services at the customer’s discretion are generally considered as options. We assess if these options provide a material right to the customer and, if so, such material rights are accounted for as separate performance obligations. If we are entitled to additional payments when the customer exercises these options, any additional payments are recorded in revenue when the customer obtains control of the goods or services. Transaction Price We have both fixed and variable consideration. Non-refundable upfront payments are considered fixed, while milestone payments are identified as variable consideration when determining the transaction price. Funding of research and development activities is considered variable until such costs are reimbursed at which point they are considered fixed. We allocate the total transaction price to each performance obligation based on the relative estimated standalone selling prices of the promised goods or services for each performance obligation. At the inception of each arrangement that includes milestone payments, we evaluate whether the milestones are considered probable of being achieved and estimate the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone is included in the transaction price. Milestone payments that are not within our control, such as approvals from regulators, are not considered probable of being achieved until those approvals are received. For arrangements that include sales-based royalties or earn-out payments, including milestone payments based on the level of sales, and the license or purchase agreement is deemed to be the predominant item to which the royalties or earn-out payments relate, we recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty or earn-out payment has been allocated has been satisfied (or partially satisfied). Allocation of Consideration As part of the accounting for these arrangements, we must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the contract. Estimated selling prices for license rights are calculated using the residual approach. For all other performance obligations, we use a cost-plus margin approach. Timing of Recognition Significant management judgment is required to determine the level of effort required under an arrangement and the period over which we expect to complete our performance obligations under an arrangement. We estimate the performance period or measure of progress at the inception of the arrangement and re-evaluate it each reporting period. This re-evaluation may shorten or lengthen the period over which revenue is recognized. Changes to these estimates are recorded on a cumulative catch up basis. If we cannot reasonably estimate when our performance obligations either are completed or become inconsequential, then revenue recognition is deferred until we can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. Revenue is recognized for licenses or sales of functional intellectual property at the point in time the customer can use and benefit from the license. For performance obligations that are services, revenue is recognized over time proportionate to the costs that we have incurred to perform the services using the cost-to-cost input method. |
Research and Development Costs and Related Accrual | Research and Development Costs and Related Accrual Research and development expenses include internal and external costs. Internal costs include salaries and employment related expenses, facility costs, administrative expenses and allocations of corporate costs. External expenses consist of costs associated with outsourced contract research organization (“CRO”) activities, sponsored research studies, product registration, patent application and prosecution, and investigator sponsored trials. We also record accruals for estimated ongoing clinical trial costs. Clinical trial costs represent costs incurred by CROs and clinical sites. These costs are recorded as a component of research and development expenses. Under our agreements, progress payments are typically made to investigators, clinical sites and CROs. We analyze 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. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share excludes the effect of dilution and is computed by dividing net loss by the weighted-average number of shares outstanding for the period. Diluted net loss per share reflects the potential dilution that could occur if securities or other contracts to issue shares were exercised into shares. In calculating diluted net loss per share, the numerator is adjusted for the change in the fair value of the warrant liability (only if dilutive) and the denominator is increased to include the number of potentially dilutive common shares assumed to be outstanding during the period using the treasury stock method. Basic and diluted net loss per share was the same for each of the periods presented. The table below presents common shares underlying stock options and warrants that are excluded from the calculation of the weighted average number of shares of common stock outstanding used for the calculation of diluted net loss per common share. These are excluded from the calculation due to their anti-dilutive effect for the years ended (in thousands): December 31, 2020 2019 Weighted-average anti-dilutive common shares resulting from stock awards 31 36 Weighted-average anti-dilutive common shares resulting from warrants 297 256 Convertible debt — 49 328 341 |
Leases | Leases In February 2016, the Financial Accounting Standards Board (the “FASB”) issued Accounting Standard Update, or ASU, No. 2016-02, Leases (Topic 842), to enhance the transparency and comparability of financial reporting related to leasing arrangements. We adopted the standard effective January 1, 2019. We determine whether the arrangement is or contains a lease at inception. Operating lease right-of-use assets and lease liabilities are recognized at the present value of the future lease payments at commencement date. The interest rate implicit in lease contracts is typically not readily determinable, and therefore, we utilize our incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received. Lease expense is recognized over the expected term on a straight-line basis. Operating leases are recognized on our balance sheet as right-of-use assets, operating lease liabilities current and operating lease liabilities non-current. We no longer recognize deferred rent on our balance sheet. The following table presents maturities of our operating lease as of December 31, 2020 (in thousands): 2021 155 Total minimum lease payments (base rent) 155 Less: imputed interest (5) Total operating lease liabilities $ 150 |
Subsequent Events | Subsequent Events We have evaluated events that have occurred subsequent to December 31, 2020 and through the date that the financial statements are issued. |
Fair Value Measurements | Fair Value Measurements We measure the fair value of financial assets and liabilities based on authoritative guidance which defines fair value, establishes a framework consisting of three levels for measuring fair value, and requires disclosures about fair value measurements. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. There are three levels of inputs that may be used to measure fair value: Level 1 – quoted prices in active markets for identical assets or liabilities; Level 2 – quoted prices for similar assets and liabilities in active markets or inputs that are observable; Level 3 – inputs that are unobservable (for example cash flow modeling inputs based on assumptions). Financial instruments, including receivables, accounts payable and accrued liabilities are carried at cost, which we believe approximates fair value due to the short-term nature of these instruments. The approximately $5.1 million and $4.9 million fair values of money market funds as of December 31, 2020 and 2019 included in our cash and cash equivalents are classified as Level 1 and were derived from quoted market prices as active markets for these instruments exists. Our warrant and derivative liabilities are classified within level 3 of the fair value hierarchy because the value is calculated using significant judgment based on our own assumptions in the valuation of these liabilities. The following table presents a roll forward of the fair value of our warrant liability, the fair value of which is determined by Level 3 inputs for the years ended (in thousands): 2020 2019 Fair value, beginning of period $ 320 $ — Issuance of warrants 1,654 1,430 Change in fair value (1) 923 (1,110) Reclassification of warrants to additional paid-in capital (2,897) — Fair value, end of period $ — $ 320 (1) Recognized as non-cash loss on changes in fair value of warrants in the statement of operations and comprehensive loss. The following table presents a roll forward of the fair value of our derivative liability, the fair value of which is determined by Level 3 inputs for the years ended (in thousands): December 31, 2020 2019 Fair value, beginning of period $ — $ 25 Issuance of derivative — — Change in fair value — (25) Fair value, end of period $ — $ — |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Accounting Standards Adopted In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement, which eliminates, adds and modifies certain disclosure requirements for fair value measurements as part of the FASB's disclosure framework project. We adopted ASU 2018-13 effective January 1, 2020 with no material impact to our financial statements and related disclosures. Accounting Standards Not Yet Adopted In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses, which requires an organization to measure all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. Financial institutions and other organizations will now use forward-looking information to better inform their credit loss estimates. The amendments in this ASU are effective for us in our interim period ending March 31, 2023. We are currently assessing the impact of the adoption of Topic 326 on our financial statements and disclosures. In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform, which provides companies with optional guidance, including expedients and exceptions for applying generally accepted accounting principles to contracts and other transactions affected by reference rate reform, such as the London Interbank Offered Rate (LIBOR). This new standard was effective upon issuance and generally can be applied to applicable contract modifications through December 31, 2022. We are evaluating the effects that the adoption of this guidance will have on our financial statements and disclosures. In August 2020, the FASB issued ASU No. 2020-06, Accounting for Convertible Instruments and Contracts in an Entity's Own Equity, which simplifies the accounting for convertible instruments. ASU 2020-06 eliminates certain models that require separate accounting for embedded conversion features, in certain cases. Additionally, among other changes, the guidance eliminates certain of the conditions for equity classification for contracts in an entity’s own equity. The guidance also requires entities to use the if converted method for all convertible instruments in the diluted earnings per share calculation and include the effect of share settlement for instruments that may be settled in cash or shares, except for certain liability-classified share-based payment awards. This guidance is effective beginning after December 15, 2023 and must be applied using either a modified or full retrospective approach. Early adoption is permitted. We are currently evaluating the impact this guidance will have on our financial statements and related disclosures. |
Organization and Summary of S_3
Organization and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Organization and Summary of Significant Accounting Policies | |
Schedule of components of inventories | As of December 31, 2020 2019 Raw materials and supplies $ 170 $ 563 Finished goods 158 — $ 328 $ 563 |
Summary of activity with respect to our product returns and discounts and rebates and allowance for doubtful accounts, which have been reclassified to discontinued operations | The following table provides a summary of activity with respect to our product returns and discounts and rebates, which have been reclassified to discontinued operations for all periods presented (in thousands): Accrued Sales Allowances Discounts and Allowance for Product Return Rebates Doubtful Allowance Allowance Total Accounts Balance at December 31, 2019 $ 721 $ 88 $ 809 $ 63 Provision 94 40 134 31 Payments/credits (759) (123) (882) (78) Balance at December 31, 2020 $ 56 $ 5 $ 61 $ 16 |
Schedule of antidilutive securities excluded from computation of net loss per common share | The table below presents common shares underlying stock options and warrants that are excluded from the calculation of the weighted average number of shares of common stock outstanding used for the calculation of diluted net loss per common share. These are excluded from the calculation due to their anti-dilutive effect for the years ended (in thousands): December 31, 2020 2019 Weighted-average anti-dilutive common shares resulting from stock awards 31 36 Weighted-average anti-dilutive common shares resulting from warrants 297 256 Convertible debt — 49 328 341 |
Schedule of maturities of operating lease | The following table presents maturities of our operating lease as of December 31, 2020 (in thousands): 2021 155 Total minimum lease payments (base rent) 155 Less: imputed interest (5) Total operating lease liabilities $ 150 |
Schedule of fair value of warrant liability | The following table presents a roll forward of the fair value of our warrant liability, the fair value of which is determined by Level 3 inputs for the years ended (in thousands): 2020 2019 Fair value, beginning of period $ 320 $ — Issuance of warrants 1,654 1,430 Change in fair value (1) 923 (1,110) Reclassification of warrants to additional paid-in capital (2,897) — Fair value, end of period $ — $ 320 (1) Recognized as non-cash loss on changes in fair value of warrants in the statement of operations and comprehensive loss. The following table presents a roll forward of the fair value of our derivative liability, the fair value of which is determined by Level 3 inputs for the years ended (in thousands): December 31, 2020 2019 Fair value, beginning of period $ — $ 25 Issuance of derivative — — Change in fair value — (25) Fair value, end of period $ — $ — |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Property and Equipment | |
Schedule of Property and Equipment | Property and equipment consisted of the following (in thousands): As of December 31, 2020 2019 Furniture and office equipment $ 388 $ 388 Leasehold improvements 408 408 Laboratory equipment 1,108 3,413 Computer equipment 1,262 1,218 Construction in progress — 73 3,166 5,500 Less accumulated depreciation and amortization (2,548) (4,683) Property and equipment, net $ 618 $ 817 |
Molteni Purchase Agreement (Tab
Molteni Purchase Agreement (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Molteni Purchase Agreement | |
Schedule of changes in contract assets and liabilities | The following table presents changes in contract assets and liabilities during the year ended December 31, 2019 (in thousands): Beginning Ending Balance Additions Deductions Balance Year ended December 31, 2019 Contract assets $ 99 — (99) $ — Contract liabilities: Deferred revenue $ 313 — (313) $ — |
Warrant Liability (Tables)
Warrant Liability (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Class of Warrant or Right [Line Items] | |
Schedule of fair value of warrant liabilities by Level 3 inputs | The following table provides a roll forward of the fair value of our warrant liabilities, the fair value of which was determined by Level 3 inputs for the year ended December 31, 2020 (in thousands): Fair value, December 31, 2019 $ 320 Issuance of the January 2020 Warrants 1,654 Change in fair value (1) 923 Reclassification of warrants to additional paid-in capital (2,897) Fair value, December 31, 2020 $ — (1) Recognized as non-cash loss on changes in fair value of warrants in the statement of operations and comprehensive loss. |
January 2020 Private Placement Warrant | |
Class of Warrant or Right [Line Items] | |
Schedule of weighted-average key assumptions used to calculate the fair value of the warrants | The warrant liability associated with the January 2020 Warrants was classified within Level 3 of the fair value hierarchy. The following table presents the weighted-average key assumptions used to calculate the fair value of the January 2020 Warrants: As of March 3, 2020 January 7, 2020 Expected volatility 124 % 121 % Risk-free interest rate 0.8 % 1.6 % Dividend yield — — Expected term (in years) 4.9 5.0 Weighted-average fair value per share warrant $ 7.80 $ 5.70 |
August 2019 Placement Warrants | |
Class of Warrant or Right [Line Items] | |
Schedule of weighted-average key assumptions used to calculate the fair value of the warrants | The warrant liability associated with the August 2019 Warrants was classified within Level 3 of the fair value hierarchy. The following table presents the weighted-average key assumptions used to calculate the fair value of the August 2019 Warrants: As of March 3, 2020 December 31, 2019 Expected volatility 124 % 125 % Risk-free interest rate 0.8 % 1.7 % Dividend yield — — Expected term (in years) 4.5 4.6 Weighted-average fair value per share warrant $ 6.30 $ 3.30 |
Placement Warrants | |
Class of Warrant or Right [Line Items] | |
Schedule of weighted-average key assumptions used to calculate the fair value of the warrants | The warrant liability associated with the Placement Warrants is classified within level 3 of the fair value hierarchy. The below table represents the weighted-average key assumptions used to calculate the fair value of the Placement Warrants: As of August 7, 2019 December 31, 2019 Expected volatility 87 % 125 % Risk-free interest rate 1.5 % 1.7 % Dividend yield — — Expected term (in years) 4.9 4.6 Weighted-average fair value per share warrant $ 15.00 $ 3.30 |
Debt Agreements (Tables)
Debt Agreements (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Restatement Due To Trigger Down Round Provision [Member] | |
Schedule of weighted-average key assumptions used to calculate the fair value of the warrants | We calculated the dividend of approximately $0.3 million resulting from the trigger of the down round provision in September 2018 using the Black Scholes Option Pricing Model and the assumptions indicated in the table below: Pre-reset Post-reset Exercise price per share $ 352.80 $ 45.00 Expected price volatility 71 % 71 % Expected term (in years) Risk-free interest rate 3.0 % 3.0 % Dividend yield 0.0 % 0.0 % Weighted-average fair value of warrants $ 9.00 $ 25.20 |
Convertible Debt | |
Schedule of weighted-average key assumptions used to calculate the fair value of the warrants | As of September 18, 2018 December 31, 2018 Expected volatility 87 % 135 % Expected term (in years) 0.75 0.50 Risk-free interest rate 2.32 % 2.51 % Dividend yield — — Fair value of conversion provision (in thousands) $ 159 $ 25 |
Horizon Warrants | |
Schedule of weighted-average key assumptions used to calculate the fair value of the warrants | Expected price volatility 86 % Expected term (in years) 7.0 Risk-free interest rate 2.8 % Dividend yield 0.0 % Weighted-average fair value per share warrant $ 145.80 |
Molteni Warrants | |
Schedule of weighted-average key assumptions used to calculate the fair value of the warrants | The key assumptions used to value the Molteni Warrants were as follows: Expected price volatility 86 % Expected term (in years) 7.0 Risk-free interest rate 2.8 % Dividend yield 0.0 % Weighted-average fair value of warrants $ 145.80 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Stockholders' Equity | |
Schedule of warrants to purchase shares | As of December 31, 2020, the following warrants to purchase shares of our common stock were outstanding (in thousands, except per share price): Date Issued Expiration Date Exercise Price Outstanding 07/27/2017 07/27/2024 $ 45.00 12 03/21/2018 03/21/2025 $ 216.00 1 03/21/2018 03/21/2025 $ 216.00 3 09/25/2018 09/25/2023 $ 18.00 154 09/25/2018 09/25/2023 $ 50.40 8 08/09/2019 02/09/2025 $ 32.10 95 10/18/2019 10/18/2024 $ 3.00 230 01/09/2020 07/09/2025 $ 7.50 290 10/30/2020 12/01/2025 $ 3.00 1,644 2,437 |
Schedule of shares of common stock reserved for future issuance | As of December 31, 2020, shares of common stock reserved by us for future issuance consisted of the following (in thousands): Stock options outstanding 28 Shares issuable upon the exercise of warrants 2,437 2,465 |
Stock Plans (Tables)
Stock Plans (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Stock Plans | |
Schedule of option activity | The following table summarizes option activity for the year ended December 31, 2020: Weighted Weighted Average Average Aggregate Exercise Remaining Intrinsic Shares Price per Contractual Value (in thousands) Share Term (years) (in thousands) Outstanding at January 1, 2020 40 $ 187.09 7.85 $ — Granted 2 7.95 Cancelled/expired (14) 49.76 Outstanding at December 31, 2020 28 $ 242.70 6.35 $ — Exercisable at December 31, 2020 27 $ 247.27 6.29 $ — |
Schedule of assumptions to estimate the fair value of options | We use the Black-Scholes-Merton option-pricing model with the following assumptions to estimate the stock-based compensation expense: Years Ended December 31, 2020 2019 Weighted-average risk-free interest rate 0.4 % 2.21 % Expected dividend payments — — Expected holding period (years)(1) Weighted-average volatility factor(2) 1.04 0.94 Estimated forfeiture rates for options granted 27 % 21 % (1) Expected holding period is based on historical experience of similar awards, giving consideration to the contractual terms of the stock-based awards, vesting schedules and the expectations of future employee behavior. (2) Weighted average volatility is based on the historical volatility of our common stock. (3) |
Schedule of the stock-based compensation expense | The following table summarizes the stock-based compensation expense (in thousands): Years Ended December 31, 2020 2019 Research and development $ — $ 91 General and administrative 7 481 Total stock-based compensation expenses $ 7 $ 572 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Taxes | |
Schedule of components of deferred tax assets | Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes and operating loss and credit carryforwards. Significant components of our deferred tax assets are as follows (in thousands): As of December 31, 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 64,120 $ 63,910 Research credit carryforwards 15,228 15,683 Other, net 1,005 1,303 Total deferred tax assets 80,353 80,896 Deferred tax liabilities: Other, net (31) (84) Total deferred tax liabilities (31) (84) Valuation allowance (80,322) (80,812) Net deferred tax assets $ — $ — |
Schedule of provision (benefit) for income taxes differs from federal statutory rate | The provision for income taxes consists of state minimum taxes due. The effective tax rate of our provision (benefit) for income taxes differs from the federal statutory rate as follows (in thousands): Years Ended December 31, 2020 2019 Computed at 21% $ (3,830) $ (3,451) State taxes (220) (146) Change in valuation allowance (491) 768 Other 26 56 Revaluation of warrant liability 194 (238) Research and development credits (65) (54) Tax attributes expirations 4,352 2,698 Impact of IRC 162m 34 367 Total $ — $ — |
Discontinued Operations (Tables
Discontinued Operations (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Discontinued Operations | |
Schedule of components of loss from discontinued operations as reported in our statements of operations and assets and liabilities reported as discontinued operations in our balance | Years ended December 31, 2020 2019 (In thousands, except per share data) Revenue: Product revenue $ 376 $ 1,006 Costs and expenses: Cost of goods sold 1,332 1,288 Research and development 1,917 2,162 Selling, general and administrative 7,224 6,524 Total costs and expenses 10,473 9,974 Loss from discontinued operations (10,097) (8,968) Other expense, net 738 — Net loss from discontinued operations $ 10,835 $ (8,968) Basic and diluted net loss per common share from discontinued operations $ (2.87) $ (11.71) Weighted average shares used in computing basic and diluted net loss per common share 3,773 766 December 31, 2020 2019 (In thousands) Receivables $ — $ 555 Inventory — 435 Prepaid expenses and other current assets 181 560 Discontinued operations – current assets $ 181 $ 1,550 Accounts payable $ 1,515 $ 585 Accrued clinical trials expenses 80 140 Accrued sales allowances 61 809 Other accrued liabilities 304 546 Discontinued operations – current liabilities $ 1,960 $ 2,080 |
Organization and Summary of S_4
Organization and Summary of Significant Accounting Policies - Components of Inventories (Details) - USD ($) | Dec. 31, 2020 | Dec. 31, 2019 |
Inventory [Line Items] | ||
Raw materials and supplies | $ 170,000 | $ 563,000 |
Finished goods | 158,000 | |
Total inventories | 328,000 | 563,000 |
Discontinued operations | U.S. commercialization activities | ||
Inventory [Line Items] | ||
Finished goods inventory reclassified to discontinued operations | $ 0 | $ 435,000 |
Organization and Summary of S_5
Organization and Summary of Significant Accounting Policies - Summary of Activity with respect to Accrued sales allowances and Allowance for doubtful accounts reclassified to discontinued operations (Details) - U.S. commercialization activities - Discontinued operations $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |
Balance at December 31, 2019 | $ 809 |
Provision | 134 |
Payments/credits | (882) |
Balance at December 31, 2020 | 61 |
Balance at December 31, 2019 | 63 |
Provision | 31 |
Payments/credits | (78) |
Balance at December 31, 2020 | 16 |
Product Return Allowance | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |
Balance at December 31, 2019 | 721 |
Provision | 94 |
Payments/credits | (759) |
Balance at December 31, 2020 | 56 |
Discounts and Rebates Allowance | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | |
Balance at December 31, 2019 | 88 |
Provision | 40 |
Payments/credits | (123) |
Balance at December 31, 2020 | $ 5 |
Organization and Summary of S_6
Organization and Summary of Significant Accounting Policies - Antidilutive Securities Excluded from Computation of Earnings Per Shares (Details) - shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 328 | 341 |
Stock Awards | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 31 | 36 |
Warrant | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 297 | 256 |
Convertible Debt | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | 0 | 49 |
Organization and Summary of S_7
Organization and Summary of Significant Accounting Policies - Fair Value of Warrant and Derivative Liability (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Schedule of Organization and Summary of Significant Accounting Policies [Line Items] | ||
Reclassification of warrants to additional paid-in capital | $ (2,897) | |
Warrant Liability | ||
Schedule of Organization and Summary of Significant Accounting Policies [Line Items] | ||
Fair value, beginning of period | 320 | $ 0 |
Issuance of warrants | 1,654 | 1,430 |
Reclassification of warrants to additional paid-in capital | (2,897) | 0 |
Change in fair value | 923 | (1,110) |
Fair value, end of period | 0 | 320 |
Derivative Liability | ||
Schedule of Organization and Summary of Significant Accounting Policies [Line Items] | ||
Fair value, beginning of period | 0 | 25 |
Issuance of derivatives | 0 | 0 |
Change in fair value | 0 | (25) |
Fair value, end of period | $ 0 | $ 0 |
Organization and Summary of S_8
Organization and Summary of Significant Accounting Policies - Maturities of operating lease liabilities (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Organization and Summary of Significant Accounting Policies | |
2021 | $ 155 |
Total minimum lease payments (base rent) | 155 |
Less: imputed interest | (5) |
Total operating lease liabilities | $ 150 |
Organization and Summary of S_9
Organization and Summary of Significant Accounting Policies - Additional information (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |
Nov. 30, 2020$ / shares | Dec. 31, 2020USD ($)segment$ / shares | Dec. 31, 2019USD ($)$ / shares | |
Schedule of Organization and Summary of Significant Accounting Policies [Line Items] | |||
Number of Operating Segments | segment | 1 | ||
Stockholders' Equity Note, Stock Split, Conversion Ratio | 0.0333 | ||
Common Stock, Par or Stated Value Per Share | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 |
Cash and cash equivalents | $ 5,413 | $ 5,223 | |
Net proceeds | $ 8,900 | ||
Substantial Doubt about Going Concern, Management's Evaluation | We assess going concern uncertainty in our financial statements to determine if we have sufficient cash on hand and working capital, including available borrowings on loans, to operate for a period of at least one year from the date the financial statements are issued or available to be issued, which is referred to as the "look-forward period" as defined by Accounting Standard Update ASU No. 2014-15. As part of this assessment, based on conditions that are known and reasonably knowable to us, we will consider various scenarios, forecasts, projections, estimates and will make certain key assumptions, including the timing and nature of projected cash expenditures or programs, and its ability to delay or curtail expenditures or programs, if necessary, among other factors. Based on this assessment, as necessary or applicable, we make certain assumptions around implementing curtailments or delays in the nature and timing of programs and expenditures to the extent we deem probable those implementations can be achieved and we have the proper authority to execute them within the look-forward period in accordance with ASU No. 2014-15.Based upon the above assessment, we concluded that, at the date of filing the financial statements in this Annual Report on Form 10-K for the year ended December 31, 2020, we did not have sufficient cash to fund our operations for the next 12 months without additional funds and, therefore, there was substantial doubt about our ability to continue as a going concern within 12 months after the date the financial statements were issued. | ||
Money Market Funds, at Carrying Value | $ 5,100 | 4,900 | |
Fair Value, Recurring | Money Market Funds | |||
Schedule of Organization and Summary of Significant Accounting Policies [Line Items] | |||
Cash and cash equivalents | $ 5,100 | $ 4,900 | |
Minimum | |||
Schedule of Organization and Summary of Significant Accounting Policies [Line Items] | |||
Property, Plant and Equipment, Estimated Useful Lives | P3Y | ||
Maximum | |||
Schedule of Organization and Summary of Significant Accounting Policies [Line Items] | |||
Property, Plant and Equipment, Estimated Useful Lives | P5Y |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 3,166 | $ 5,500 |
Less accumulated depreciation and amortization | (2,548) | (4,683) |
Property and equipment, net | 618 | 817 |
Furniture and office equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 388 | 388 |
Leasehold improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 408 | 408 |
Laboratory equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 1,108 | 3,413 |
Computer equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | 1,262 | 1,218 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross | $ 0 | $ 73 |
Molteni Purchase Agreement - Ch
Molteni Purchase Agreement - Changes in contract assets and liabilities (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2019USD ($) | |
Molteni Purchase Agreement | |
Contract assets | $ 99 |
Contract assets, Additions | 0 |
Contract asset, Deductions | (99) |
Contract assets | 0 |
Deferred revenue | 313 |
Deferred revenue, Additions | 0 |
Deferred revenue, Deductions | (313) |
Deferred revenue | $ 0 |
Molteni Purchase Agreement (Det
Molteni Purchase Agreement (Details) | Mar. 21, 2018EUR (€) | Mar. 21, 2018USD ($) | Aug. 31, 2018USD ($) | Mar. 31, 2018EUR (€) | Mar. 31, 2018USD ($) | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Oct. 31, 2020USD ($) | Aug. 31, 2018EUR (€) | Aug. 31, 2018USD ($) | Mar. 31, 2018USD ($) |
Purchase Agreement | |||||||||||
Proceeds from Sale of Productive Assets | € 2,000,000 | $ 2,448,000 | |||||||||
Amount Received Under Amendment To Purchase Agreement | 950,000 | € 950,000 | $ 1,100,000 | $ 1,107,000 | |||||||
Estimated Selling Price | $ 1,400,000 | ||||||||||
Amount Received Under Amendment To Purchase Agreement | € 950,000 | 950,000 | 1,100,000 | $ 1,107,000 | |||||||
Convertible Debt | € 550,000 | $ 600,000 | |||||||||
Revenue recognized | € 2,000,000 | $ 2,300,000 | |||||||||
Revenue from Contract with Customer, Including Assessed Tax | $ 1,100,000 | 4,838,000 | $ 2,605,000 | ||||||||
Debt obligations in cash | $ 1,600,000 | ||||||||||
Intellectual Property [Member] | |||||||||||
Purchase Agreement | |||||||||||
Finite-Lived Intangible Assets, Translation and Purchase Accounting Adjustments | $ 1,000,000 | ||||||||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Start Date [Axis]: 2019-04-01 | |||||||||||
Purchase Agreement | |||||||||||
Revenue, Remaining Performance Obligation, Expected Timing of Satisfaction, Period | 15 years |
JT Pharmaceuticals Asset Purc_2
JT Pharmaceuticals Asset Purchase Agreement (Details) $ in Thousands | 1 Months Ended |
Oct. 31, 2020USD ($) | |
JT Pharmaceuticals | |
Asset Purchase Agreement [Line Items] | |
Closing payment | $ 15,000 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Commitments and Contingencies. | ||
Rent expense | $ 0.3 | $ 0.3 |
Minimum manufacturing fee | $ 1 |
Warrant Liability - Fair value
Warrant Liability - Fair value of warrant liabilities by Level 3 inputs (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Mar. 03, 2020 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Warrants to purchase shares of common stock | 1,112,313 | ||
Fair value of warrant liabilities by Level 3 inputs | |||
Beginning balance | $ 320 | ||
Issuance of the January 2020 Warrants | 1,654 | ||
Change in fair value | 923 | $ (1,110) | |
Reclassification of warrants to additional paid-in capital | (2,897) | ||
Ending balance | $ 0 | $ 320 | |
Warrant | |||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Warrants to purchase shares of common stock | 385,078 |
Warrant Liability - Weighted-av
Warrant Liability - Weighted-average key assumptions (Details) | Mar. 03, 2020 | Jan. 07, 2020 | Dec. 31, 2019 | Aug. 07, 2019 |
January 2020 Private Placement Warrant | Expected volatility | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants and rights outstanding | 124 | 121 | ||
January 2020 Private Placement Warrant | Risk-free interest rate | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants and rights outstanding | 0.8 | 1.6 | ||
January 2020 Private Placement Warrant | Expected term (in years) | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants and rights outstanding | 4.9 | 5 | ||
January 2020 Private Placement Warrant | Weighted-average fair value per share warrant | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants and rights outstanding | 7.80 | 5.70 | ||
August 2019 Placement Warrants | Expected volatility | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants and rights outstanding | 124 | 125 | ||
August 2019 Placement Warrants | Risk-free interest rate | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants and rights outstanding | 0.8 | 1.7 | ||
August 2019 Placement Warrants | Expected term (in years) | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants and rights outstanding | 4.5 | 4.6 | ||
August 2019 Placement Warrants | Weighted-average fair value per share warrant | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants and rights outstanding | 6.30 | 3.30 | ||
Placement Warrants | August 2019 Offering | Expected volatility | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants and rights outstanding | 125 | 87 | ||
Placement Warrants | August 2019 Offering | Risk-free interest rate | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants and rights outstanding | 1.7 | 1.5 | ||
Placement Warrants | August 2019 Offering | Dividend yield | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants and rights outstanding | 0 | 0 | ||
Placement Warrants | August 2019 Offering | Expected term (in years) | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants and rights outstanding | 4.6 | 4.9 | ||
Placement Warrants | August 2019 Offering | Weighted-average fair value per share warrant | ||||
Class of Warrant or Right [Line Items] | ||||
Warrants and rights outstanding | 3.30 | 15 |
Warrant Liability - Additional
Warrant Liability - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | Dec. 31, 2020 | Dec. 31, 2019 | Aug. 31, 2019 |
Class of Warrant or Right [Line Items] | |||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,112,313 | ||
August 2019 Offering | |||
Class of Warrant or Right [Line Items] | |||
Total fair value of placement warrants | $ 0.3 | ||
Common Stock | August 2019 Offering | |||
Class of Warrant or Right [Line Items] | |||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 95,078 | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 32.10 |
Debt Agreements - Horizon and M
Debt Agreements - Horizon and Molteni warrants (Details) | 12 Months Ended |
Dec. 31, 2020$ / shares | |
Horizon Warrants | |
Assumption | |
Weighted-average fair value of warrants | $ 145.80 |
Horizon Warrants | Measurement Input, Price Volatility [Member] | |
Assumption | |
Fair Value Assumptions Rate | 86.00% |
Horizon Warrants | Expected term (in years) | |
Assumption | |
Fair Value Assumptions Term | 7 years |
Horizon Warrants | Risk-free interest rate | |
Assumption | |
Fair Value Assumptions Rate | 2.80% |
Horizon Warrants | Dividend yield | |
Assumption | |
Fair Value Assumptions Rate | 0.00% |
Molteni Warrants | |
Assumption | |
Weighted-average fair value of warrants | $ 145.80 |
Molteni Warrants | Measurement Input, Price Volatility [Member] | |
Assumption | |
Fair Value Assumptions Rate | 86.00% |
Molteni Warrants | Expected term (in years) | |
Assumption | |
Fair Value Assumptions Term | 7 years |
Molteni Warrants | Risk-free interest rate | |
Assumption | |
Fair Value Assumptions Rate | 2.80% |
Molteni Warrants | Dividend yield | |
Assumption | |
Fair Value Assumptions Rate | 0.00% |
Debt Agreements - Pre-reset and
Debt Agreements - Pre-reset and post-reset (Details) | 12 Months Ended |
Dec. 31, 2020$ / shares | |
Pre Reset [Member] | |
Weighted Average Fair Value Assumptions of Warrants | $ 9 |
Pre Reset [Member] | Measurement Input, Exercise Price [Member] | |
Fair Value Assumptions Price Per Share | $ 352.80 |
Pre Reset [Member] | Measurement Input, Price Volatility [Member] | |
Fair Value Assumptions Rate | 71.00% |
Pre Reset [Member] | Expected term (in years) | |
Fair Value Assumptions Term | 5 years 9 months 18 days |
Pre Reset [Member] | Risk-free interest rate | |
Fair Value Assumptions Rate | 3.00% |
Pre Reset [Member] | Dividend yield | |
Fair Value Assumptions Rate | 0.00% |
Post Reset [Member] | |
Weighted Average Fair Value Assumptions of Warrants | $ 25.20 |
Post Reset [Member] | Measurement Input, Exercise Price [Member] | |
Fair Value Assumptions Price Per Share | $ 45 |
Post Reset [Member] | Measurement Input, Price Volatility [Member] | |
Fair Value Assumptions Rate | 71.00% |
Post Reset [Member] | Expected term (in years) | |
Fair Value Assumptions Term | 5 years 9 months 18 days |
Post Reset [Member] | Risk-free interest rate | |
Fair Value Assumptions Rate | 3.00% |
Post Reset [Member] | Dividend yield | |
Fair Value Assumptions Rate | 0.00% |
Debt Agreements - Convertible L
Debt Agreements - Convertible Loan (Details) $ in Thousands | Dec. 31, 2019USD ($) | Sep. 18, 2018USD ($) |
Fair value of conversion provision | $ 25 | $ 159 |
Measurement Input, Price Volatility [Member] | ||
Convertible loan embedded derivative, assumptions used | 135 | 87 |
Expected term (in years) | ||
Convertible loan embedded derivative, assumptions used | 0.50 | 0.75 |
Risk-free interest rate | ||
Convertible loan embedded derivative, assumptions used | 2.51 | 2.32 |
Dividend yield | ||
Convertible loan embedded derivative, assumptions used | 0 | 0 |
Debt Agreements - Additional in
Debt Agreements - Additional information (Details) - USD ($) | Apr. 20, 2020 | Jul. 27, 2017 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2018 | Feb. 28, 2018 | Jul. 27, 2017 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Oct. 31, 2020 | Sep. 30, 2018 | Mar. 21, 2018 |
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,112,313 | ||||||||||||
Gain (Loss) on Extinguishment of Debt | $ (81,000) | $ 226,000 | |||||||||||
Loan proceeds | 654,000 | 0 | |||||||||||
Current portion of long-term debt | 327,000 | 0 | |||||||||||
Long-term debt, net of debt discount of $0 and $346 | 332,000 | 4,019,000 | |||||||||||
Horizon Technology Finance Corporation | |||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 45 | ||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 12,223 | ||||||||||||
Class Of Warrant Or Right Terms | 7 years | ||||||||||||
Venture Loan | |||||||||||||
Debt Instrument, Face Amount | $ 7,000,000 | $ 7,000,000 | |||||||||||
Debt Instrument Final Payment On Each Loan Tranche percentage | 5.00% | ||||||||||||
Early Repayment of Subordinated Debt | $ 3,000,000 | ||||||||||||
Long-term Debt | $ 7,000,000 | ||||||||||||
Venture Loan | Horizon Technology Finance Corporation | |||||||||||||
Debt Instrument, Term | 46 months | ||||||||||||
Debt Instrument, Description of Variable Rate Basis | one-month LIBOR (floor of 1.10%) plus 8.40% | ||||||||||||
Molteni Loan | |||||||||||||
Class Of Warrant Or Right Terms | 7 years | ||||||||||||
Long-term Debt | $ 4,000,000 | ||||||||||||
Conversion Price, (in dollars per share) | $ 6.75 | ||||||||||||
Debt Conversion, Converted Instrument, Shares Issued | 114,093 | ||||||||||||
Gain (Loss) on Extinguishment of Debt | $ 300,000 | ||||||||||||
Increase in Repayment of Long-term Debt | $ 300,000 | ||||||||||||
Horizon Loan | |||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 216 | ||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 223 | ||||||||||||
Long-term Debt | $ 2,400,000 | ||||||||||||
Conversion Price, (in dollars per share) | $ 216 | ||||||||||||
Stockholders' Equity Note, Changes in Capital Structure, Subsequent Changes to Number of Common Shares, Amount | $ 10,000,000 | ||||||||||||
Debt Instrument, Periodic Payment | $ 1,600,000 | ||||||||||||
Horizon and Molteni Loans | |||||||||||||
Long-term Debt | $ 1,600,000 | ||||||||||||
Gain (Loss) on Extinguishment of Debt | (100,000) | ||||||||||||
Molteni Purchase Agreement | |||||||||||||
Conversion Price, (in dollars per share) | $ 45 | ||||||||||||
Debt Conversion, Converted Instrument, Shares Issued | 14,943 | ||||||||||||
Gain (Loss) on Extinguishment of Debt | $ (100,000) | ||||||||||||
PPP loans | |||||||||||||
Debt Instrument, Term | 6 months | ||||||||||||
Loan proceeds | $ 654,000 | ||||||||||||
Loan annual interest rate | 1.00% | ||||||||||||
Current portion of long-term debt | 300,000 | ||||||||||||
Long-term debt, net of debt discount of $0 and $346 | $ 300,000 | ||||||||||||
Minimum | Venture Loan | Horizon Technology Finance Corporation | |||||||||||||
Debt Instrument Additional Face Amount | $ 10,000,000 | $ 10,000,000 | |||||||||||
Maximum | PPP loans | |||||||||||||
Debt Instrument, Term | 16 months | ||||||||||||
New Horizon Warrants | |||||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 216 | ||||||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 3,000 |
Stockholders' Equity - Warrants
Stockholders' Equity - Warrants to purchase shares (Details) shares in Thousands | 12 Months Ended |
Dec. 31, 2020$ / sharesshares | |
Class of Warrant or Right | |
Outstanding | 2,437 |
Class of Warrant or Right Issued Date One [Member] | |
Class of Warrant or Right | |
Date Issued | Jul. 27, 2017 |
Expiration Date | Jul. 27, 2024 |
Exercise Price (in dollars per share) | $ / shares | $ 45 |
Outstanding | 12 |
Class of Warrant or Right Issued Date Two [Member] | |
Class of Warrant or Right | |
Date Issued | Mar. 21, 2018 |
Expiration Date | Mar. 21, 2025 |
Exercise Price (in dollars per share) | $ / shares | $ 216 |
Outstanding | 1 |
Class of Warrant or Right Issued Date Three [Member] | |
Class of Warrant or Right | |
Date Issued | Mar. 21, 2018 |
Expiration Date | Mar. 21, 2025 |
Exercise Price (in dollars per share) | $ / shares | $ 216 |
Outstanding | 3 |
Class Of Warrant or Right Issued Date Four [Member] | |
Class of Warrant or Right | |
Date Issued | Sep. 25, 2018 |
Expiration Date | Sep. 25, 2023 |
Exercise Price (in dollars per share) | $ / shares | $ 18 |
Outstanding | 154 |
Class Of Warrant or Right Issued Date Five [Member] | |
Class of Warrant or Right | |
Date Issued | Sep. 25, 2018 |
Expiration Date | Sep. 25, 2023 |
Exercise Price (in dollars per share) | $ / shares | $ 50.40 |
Outstanding | 8 |
Class Of Warrant or Right Issued Date Six [Member] | |
Class of Warrant or Right | |
Date Issued | Aug. 9, 2019 |
Expiration Date | Feb. 9, 2025 |
Exercise Price (in dollars per share) | $ / shares | $ 32.10 |
Outstanding | 95 |
Class Of Warrant or Right Issued Date Seven [Member] | |
Class of Warrant or Right | |
Date Issued | Oct. 18, 2019 |
Expiration Date | Oct. 18, 2024 |
Exercise Price (in dollars per share) | $ / shares | $ 3 |
Outstanding | 230 |
Class Of Warrant or Right Issued Date Eight [Member] | |
Class of Warrant or Right | |
Date Issued | Jan. 9, 2020 |
Expiration Date | Jul. 9, 2025 |
Exercise Price (in dollars per share) | $ / shares | $ 7.50 |
Outstanding | 290 |
Class Of Warrant Or Right Issued Date Nine [Member] | |
Class of Warrant or Right | |
Date Issued | Oct. 30, 2020 |
Expiration Date | Dec. 1, 2025 |
Exercise Price (in dollars per share) | $ / shares | $ 3 |
Outstanding | 1,644 |
Stockholders' Equity - Common s
Stockholders' Equity - Common stock reserved for future issuance (Details) shares in Thousands | Dec. 31, 2020shares |
Schedule of common stock reserved for future issuance | |
Common Stock, Capital Shares Reserved for Future Issuance | 2,465 |
Warrant | |
Schedule of common stock reserved for future issuance | |
Common Stock, Capital Shares Reserved for Future Issuance | 2,437 |
Employee Stock Option | |
Schedule of common stock reserved for future issuance | |
Common Stock, Capital Shares Reserved for Future Issuance | 28 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional information (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||||
Oct. 31, 2020 | Sep. 30, 2020 | Jan. 31, 2020 | Oct. 31, 2019 | Aug. 31, 2019 | Apr. 30, 2019 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | |
Class of Warrant or Right [Line Items] | |||||||||
Net proceeds | $ 8,900 | ||||||||
Issuance of common stock, net | $ 10,194 | $ 8,237 | |||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,112,313 | ||||||||
Finance costs for issuance of warrants | $ 211 | 0 | |||||||
Class of Warrant or Right, Outstanding | 2,437,000 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Gross | 2,000 | ||||||||
Proceeds from Warrant Exercises | $ 7,243 | $ 1,603 | |||||||
Issuance of common stock upon exercises of warrants, net (in shares) | 450,761 | ||||||||
Common Stock | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Issuance of common stock, net (in shares) | 3,605,000 | 1,257,000 | |||||||
Issuance of common stock, net | $ 4 | $ 1 | |||||||
Issuance of common stock upon exercises of warrants, net (in shares) | 1,563,000 | 207,000 | |||||||
Warrant | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,022,408 | ||||||||
October 2020 Offering | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Number of units issued | 2,666,667 | ||||||||
Shares Issued, Price Per Share | $ 3 | ||||||||
Number of shares that each unit entitles | 1 | ||||||||
Number of warrant that each unit entitles | 1 | ||||||||
Number of shares that each warrant entitles | 1 | ||||||||
Proceeds from sale of common stock | $ 8,000 | ||||||||
Underwriting discounts and commissions | 1,600 | ||||||||
Net proceeds | $ 5,700 | ||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 3 | ||||||||
September 2020 Offering | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Shares Issued, Price Per Share | $ 4.20 | $ 4.20 | |||||||
Proceeds from sale of common stock | $ 2,400 | ||||||||
Issuance of common stock, net (in shares) | 648,000 | ||||||||
January 2020 Offering | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Proceeds from sale of common stock | $ 1,900 | ||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 7.50 | ||||||||
Issuance of common stock, net (in shares) | 290,000 | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 290,000 | ||||||||
Finance costs for issuance of warrants | $ 200 | ||||||||
October 2019 Offering | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Shares Issued, Price Per Share | $ 6.75 | ||||||||
Issuance of common stock, net (in shares) | 1,342,534 | ||||||||
October 2019 Offering | Common Stock | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Issuance of common stock, net (in shares) | 1,196,200 | ||||||||
October 2019 Offering | Pre-Funded Warrants [Member] | Common Stock | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.30 | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 146,334 | ||||||||
October 2019 Offering | Placement Warrants | Class B Units [Member] | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 6.75 | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 1,342,534 | ||||||||
August 2019 Offering | Common Stock | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 32.10 | ||||||||
Issuance of common stock, net (in shares) | 49,334 | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 95,078 | ||||||||
August 2019 Offering | Pre-Funded Warrants [Member] | Common Stock | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.30 | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 45,744 | ||||||||
August 2019 Offering | Placement Warrants | Common Stock | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 32.10 | ||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 95,078 | ||||||||
ATM | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Shares Issued, Price Per Share | $ 48 | ||||||||
Proceeds from sale of common stock | $ 500 | ||||||||
Issuance of common stock, net (in shares) | 10,989 | ||||||||
ATM | Maximum | |||||||||
Class of Warrant or Right [Line Items] | |||||||||
Issuance of common stock, net | $ 800 | $ 4,000 | $ 8,600 |
Stock Plans - stock option acti
Stock Plans - stock option activity (Details) - $ / shares shares in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Stock Plans | ||
Number of options outstanding at Beginning of year | 40 | |
Shares, Granted | 2 | |
Shares, Cancelled | (14) | |
Number of Options and Awards outstanding at end of year | 28 | 40 |
Shares, Exercisable at end of year | 27 | |
Weighted Average Exercise Price, Outstanding at Beginning of year | $ 187.09 | |
Weighted Average Exercise Price, Granted | 7.95 | |
Weighted Average Exercise Price, Cancelled | 49.76 | |
Weighted Average Exercise Price, Outstanding at End of year | 242.70 | $ 187.09 |
Weighted Average Exercise Price, Exercisable at end of year | $ 247.27 | |
Weighted Average Remaining Contractual Term, Outstanding (Years) | 6 years 4 months 6 days | 0 years |
Weighted Average Remaining Contractual Term, Exercisable at end of year | 6 years 3 months 15 days |
Stock Plans - Fair value of sto
Stock Plans - Fair value of stock options (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Stock Plans | ||
Weighted-average risk-free interest rate | 0.40% | 2.21% |
Expected dividend payments | $ 0 | $ 0 |
Expected holding period (years) | 5 years 9 months 15 days | 5 years 4 months 28 days |
Weighted-average volatility factor | 1.04% | 0.94% |
Estimated forfeiture rates for options granted | 27.00% | 21.00% |
Stock Plans - Stock-based compe
Stock Plans - Stock-based compensation expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost | ||
Total stock-based compensation expense | $ 7 | $ 572 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost | ||
Total stock-based compensation expense | 91 | |
Selling, general and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost | ||
Total stock-based compensation expense | $ 7 | $ 481 |
Stock Plans - Additional inform
Stock Plans - Additional information (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||||||
Jan. 31, 2019 | Jul. 31, 2002 | Aug. 31, 2001 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 31, 2021 | Dec. 31, 2018 | Aug. 31, 2015 | Feb. 28, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Weighted-average period for recognizing non-vested stock option | 1 year 4 months 24 days | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 28,000 | 40,000 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 6.30 | $ 49.20 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested, Number of Shares | 4,071 | ||||||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range, Lower Range Limit | $ 630 | ||||||||
Increase In The Price In Respect Of Lower Range In Respect Of Shares Authorised Under Compensation Plan | $ 46.50 | ||||||||
Employee Stock Option | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized | $ 5,500,000,000 | ||||||||
Common Stock | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Shares, Outstanding | 7,139,000 | 1,913,000 | 434,000 | ||||||
2002 Plan [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 7,234 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 1,426 | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award Percentage Of Fair Market Value Of Common Stock For Calculating Exercise Price | 100.00% | ||||||||
2001 Non-Qualified Plan [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 1,768 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 412 | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award Percentage Of Fair Market Value Of Common Stock For Calculating Exercise Price | 100.00% | ||||||||
2015 Plan | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 55,556 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 30,786 | ||||||||
2015 Plan | Subsequent Events | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 1,000,000 | ||||||||
2015 Plan | Common Stock | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Shares, Outstanding | 24,770 | ||||||||
2014 Plan [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 2,526 | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Number | 1,285 | ||||||||
Stock Compensation Plan | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Plan Modification, Incremental Compensation Cost | $ 81,000 | ||||||||
Research and development | Stock Compensation Plan | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Plan Modification, Incremental Compensation Cost | 54,000 | ||||||||
Selling, general and administrative | Stock Compensation Plan | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Plan Modification, Incremental Compensation Cost | $ 27,000 |
Income Taxes - Deferred tax ass
Income Taxes - Deferred tax assets (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 64,120 | $ 63,910 |
Research credit carryforwards | 15,228 | 15,683 |
Other, net | 1,005 | 1,303 |
Total deferred tax assets | 80,353 | 80,896 |
Other, net | (31) | (84) |
Total deferred tax liabilities | (31) | (84) |
Valuation allowance | (80,322) | (80,812) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes - Provision for in
Income Taxes - Provision for income taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Effective Income Tax Rate Reconciliation, Amount [Abstract] | ||
Computed at 21% | $ (3,830) | $ (3,451) |
State taxes | (220) | (146) |
Change in valuation allowance | (491) | 768 |
Other | 26 | 56 |
Revaluation of warrant liability | 194 | (238) |
Research and development credits | (65) | (54) |
Tax attributes expirations | 4,352 | 2,698 |
Impact of IRC 162m | 34 | 367 |
Total | $ 0 | $ 0 |
Income Taxes - Additional infor
Income Taxes - Additional information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Tax Disclosure [Line Items] | ||
Operating Loss Carry forwards Not Subject To Expiration | $ 41,800,000 | |
Operating Loss Carryforwards, Limitations on Use Percentage | 80.00% | |
Valuation Allowance, Deferred Tax Asset, Increase (Decrease), Amount | $ 500,000 | $ 700,000 |
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21.00% | 21.00% |
Unrecognized Tax Benefits | $ 0 | |
California Franchise Tax Board [Member] | ||
Income Tax Disclosure [Line Items] | ||
Operating Loss Carry Forwards Expiration Year | 2040 | |
Operating Loss Carryforwards | $ 109,700,000 | |
Domestic Tax Authority [Member] | ||
Income Tax Disclosure [Line Items] | ||
Operating Loss Carry Forwards Expiration Year | 2037 | |
Operating Loss Carryforwards | $ 227,000,000 | |
Domestic Tax Authority [Member] | Research Tax Credit Carryforward [Member] | ||
Income Tax Disclosure [Line Items] | ||
Operating Loss Carry Forwards Expiration Year | 2040 | |
Operating Loss Carryforwards | $ 8,000,000 | |
State and Local Jurisdiction [Member] | Research Tax Credit Carryforward [Member] | ||
Income Tax Disclosure [Line Items] | ||
Tax Credit Carryforward, Amount | $ 9,200,000 |
Discontinued Operations - Compo
Discontinued Operations - Components of loss as reported in statements of operations (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Costs and expenses: | ||
Net loss from discontinued operations | $ (10,835) | $ (8,968) |
Basic and diluted net loss per common share from discontinued operations | $ (2.87) | $ (11.71) |
Weighted average shares used in computing basic and diluted net loss per common share | 3,773 | 766 |
U.S. commercialization activities | Discontinued operations | ||
Revenue: | ||
Product revenue | $ 376 | $ 1,006 |
Costs and expenses: | ||
Cost of goods sold | 1,332 | 1,288 |
Research and development | 1,917 | 2,162 |
Selling, general and administrative | 7,224 | 6,524 |
Total costs and expenses | 10,473 | 9,974 |
Loss from discontinued operations | (10,097) | (8,968) |
Other expense, net | 738 | 0 |
Net loss from discontinued operations | $ 10,835 | $ (8,968) |
Basic and diluted net loss per common share from discontinued operations | $ (2.87) | $ (11.71) |
Weighted average shares used in computing basic and diluted net loss per common share | 3,773 | 766 |
Discontinued Operations - Asset
Discontinued Operations - Assets and liabilities reported as discontinued operations in balance sheet (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Disposal GrDiscontinued operations - current assetsoup, Including Discontinued Operation, Assets, Current, Total | $ 181,000 | $ 1,550,000 |
Discontinued operations - current liabilities | 1,960,000 | 2,080,000 |
U.S. commercialization activities | Discontinued operations | ||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations [Line Items] | ||
Receivables | 0 | 555,000 |
Inventory | 0 | 435,000 |
Prepaid expenses and other current assets | 181,000 | 560,000 |
Disposal GrDiscontinued operations - current assetsoup, Including Discontinued Operation, Assets, Current, Total | 181,000 | 1,550,000 |
Accounts payable | 1,515,000 | 585,000 |
Accrued clinical trials expenses | 80,000 | 140,000 |
Accrued sales allowances | 61,000 | 809,000 |
Other accrued liabilities | 304,000 | 546,000 |
Discontinued operations - current liabilities | 1,960,000 | 2,080,000 |
Non-cash stock-based compensation expenses | $ 100,000 | $ 100,000 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 12 Months Ended | |
Jan. 31, 2021 | Dec. 31, 2020 | Aug. 31, 2015 | |
Subsequent Event [Line Items] | |||
Number of warrants to purchase | 1,112,313 | ||
Net cash proceeds | $ 8.9 | ||
2015 Plan | |||
Subsequent Event [Line Items] | |||
Authorized shares | 55,556 | ||
Subsequent Events | 2015 Plan | |||
Subsequent Event [Line Items] | |||
Authorized shares | 1,000,000 | ||
Subsequent Events | January 2021 Offering | |||
Subsequent Event [Line Items] | |||
Issuance of common stock, net (in shares) | 2,725,000 | ||
Number of warrants to purchase | 2,725,000 | ||
Exercise price of warrants (in dollars per share) | $ 3.55 | ||
Net cash proceeds | $ 8.9 |