Cover
Cover - shares | Jun. 15, 2021 | Sep. 30, 2021 | Nov. 10, 2021 |
Entity Information [Line Items] | |||
Document Type | 10-Q | ||
Amendment Flag | false | ||
Document Quarterly Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Sep. 30, 2021 | ||
Document Fiscal Period Focus | Q3 | ||
Document Fiscal Year Focus | 2021 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity File Number | 001-38738 | ||
Entity Registrant Name | ETON PHARMACEUTICALS, INC. | ||
Entity Central Index Key | 0001710340 | ||
Entity Tax Identification Number | 37-1858472 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Address, Address Line One | 21925 W. Field Parkway | ||
Entity Address, Address Line Two | Suite 235 | ||
Entity Address, City or Town | Deer Park | ||
Entity Address, State or Province | IL | ||
Entity Address, Postal Zip Code | 60010-7278 | ||
City Area Code | (847) | ||
Local Phone Number | 787-7361 | ||
Title of 12(b) Security | Common stock, $0.001 par value per share | ||
Trading Symbol | ETON | ||
Security Exchange Name | NASDAQ | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Elected Not To Use the Extended Transition Period | true | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 24,606,175 | ||
Distribution and Promotion License Agreement [Member] | Crossject S.A. [Member] | Sales Exceed $10 Million [Member] | |||
Entity Information [Line Items] | |||
Milestone payment description | 1,000 when net sales exceed $10 million in any four consecutive quarters | ||
Distribution and Promotion License Agreement [Member] | Crossject S.A. [Member] | Sales Exceed $20 Million [Member] | |||
Entity Information [Line Items] | |||
Milestone payment description | 2,000 when net sales exceed $20 million in any four consecutive quarters | ||
Distribution and Promotion License Agreement [Member] | Crossject S.A. [Member] | Sales Exceed $30 Million [Member] | |||
Entity Information [Line Items] | |||
Milestone payment description | 3,000 when net sales exceed $30 million in any four consecutive quarters |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 22,709 | $ 21,295 |
Accounts receivable, net | 385 | 48 |
Inventories | 334 | 1,242 |
Prepaid expenses and other current assets | 2,435 | 2,116 |
Total current assets | 25,863 | 24,701 |
Property and equipment, net | 134 | 811 |
Intangible assets, net | 463 | 575 |
Operating lease right-of-use assets, net | 123 | 192 |
Other long-term assets, net | 23 | 40 |
Total assets | 26,606 | 26,319 |
Current liabilities: | ||
Accounts payable | 3,273 | 2,344 |
Current portion of long-term debt | 1,092 | |
PPP loan, current portion | 280 | |
Accrued liabilities | 995 | 1,170 |
Total current liabilities | 5,360 | 3,794 |
Long-term debt, net of discount and including accrued fees | 5,550 | 6,532 |
Long-term portion of PPP and EIDL loans | 231 | |
Operating lease liabilities, net of current portion | 36 | 99 |
Total liabilities | 10,946 | 10,656 |
Commitments and contingencies (Note 12) | ||
Stockholders’ equity | ||
Common stock, $0.001 par value; 50,000,000 shares authorized as of September 30, 2021 and December 31, 2020; 24,606,175 and 24,312,808 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively | 25 | 24 |
Additional paid-in capital | 110,787 | 107,797 |
Accumulated deficit | (95,152) | (92,158) |
Total stockholders’ equity | 15,660 | 15,663 |
Total liabilities and stockholders’ equity | $ 26,606 | $ 26,319 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 50,000,000 | 50,000,000 |
Common stock, shares issued | 24,606,175 | 24,312,808 |
Common stock, shares outstanding | 24,606,175 | 24,312,808 |
Condensed Statements of Operati
Condensed Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenues: | ||||
Total net revenues | $ 775 | $ (161) | $ 15,739 | $ (42) |
Cost of sales: | ||||
Total cost of sales | 617 | (144) | 2,343 | (14) |
Gross profit (loss) | 158 | (17) | 13,396 | (28) |
Operating expenses: | ||||
Research and development | 2,678 | 2,826 | 5,554 | 10,703 |
General and administrative | 3,327 | 3,429 | 10,651 | 8,960 |
Total operating expenses | 6,005 | 6,255 | 16,205 | 19,663 |
Loss from operations | (5,847) | (6,272) | (2,809) | (19,691) |
Other (expense) income: | ||||
Interest and other (expense) income, net | (247) | (232) | (731) | (592) |
Gain on PPP loan forgiven | 365 | |||
Gain on equipment sale | 181 | |||
Loss before income tax expense | (6,094) | (6,504) | (2,994) | (20,283) |
Income tax expense | ||||
Net loss | $ (6,094) | $ (6,504) | $ (2,994) | $ (20,283) |
Net loss per share, basic and diluted | $ (0.24) | $ (0.31) | $ (0.12) | $ (1.01) |
Weighted average number of common shares outstanding, basic and diluted | 25,276,153 | 21,052,174 | 25,181,095 | 20,070,430 |
Licensing Revenue [Member] | ||||
Revenues: | ||||
Total net revenues | $ 14,000 | |||
Cost of sales: | ||||
Total cost of sales | 1,500 | |||
Product [Member] | ||||
Revenues: | ||||
Total net revenues | 775 | (161) | 1,739 | (42) |
Cost of sales: | ||||
Total cost of sales | $ 617 | $ (144) | $ 843 | $ (14) |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Balances at Dec. 31, 2019 | $ 18 | $ 74,720 | $ (64,188) | $ 10,550 |
Balance, shares at Dec. 31, 2019 | 17,877,486 | |||
Stock-based compensation | 1,803 | 1,803 | ||
Stock-based compensation, shares | 15,190 | |||
Stock option exercises | 140 | 140 | ||
Stock option exercises,shares | 102,378 | |||
Relative fair value of warrants to purchase common stock issued in connection with debt | 94 | 94 | ||
Employee stock purchase plan | 64 | 64 | ||
Employee stock purchase plan,shares | 14,005 | |||
Proceeds from sales of common stock, net of offering costs | $ 3 | 7,753 | 7,756 | |
proceeds from sales of common stock, net of offering costs,shares | 2,600,000 | |||
Issuance of common stock for product candidate licensing rights | 1,264 | 1,264 | ||
Issuance of common stock for product candidate licensing rights,shares | 379,474 | |||
Net loss | (20,283) | (20,283) | ||
Balances at Sep. 30, 2020 | $ 21 | 85,838 | (84,471) | 1,388 |
Balance, shares at Sep. 30, 2020 | 20,988,533 | |||
Balances at Jun. 30, 2020 | $ 21 | 84,977 | (77,967) | 7,031 |
Balance, shares at Jun. 30, 2020 | 20,956,033 | |||
Stock-based compensation | 724 | 724 | ||
Stock option exercises | 43 | 43 | ||
Stock option exercises,shares | 32,500 | |||
Relative fair value of warrants to purchase common stock issued in connection with debt | 94 | 94 | ||
Net loss | (6,504) | (6,504) | ||
Balances at Sep. 30, 2020 | $ 21 | 85,838 | (84,471) | 1,388 |
Balance, shares at Sep. 30, 2020 | 20,988,533 | |||
Balances at Dec. 31, 2020 | $ 24 | 107,797 | (92,158) | 15,663 |
Balance, shares at Dec. 31, 2020 | 24,312,808 | |||
Stock-based compensation | 2,518 | 2,518 | ||
Stock option exercises | $ 1 | 338 | 339 | |
Stock option exercises,shares | 144,233 | |||
Relative fair value of warrants to purchase common stock issued in connection with debt | ||||
Employee stock purchase plan | 134 | 134 | ||
Employee stock purchase plan,shares | 29,326 | |||
Common stock issued related to restricted stock units | ||||
Common stock issued related to restricted stock units, shares | 25,000 | |||
Warrant exercises | ||||
Warrant exercises, shares | 94,808 | |||
Net loss | (2,994) | (2,994) | ||
Balances at Sep. 30, 2021 | $ 25 | 110,787 | (95,152) | 15,660 |
Balance, shares at Sep. 30, 2021 | 24,606,175 | |||
Balances at Jun. 30, 2021 | $ 25 | 109,769 | (89,058) | 20,736 |
Balance, shares at Jun. 30, 2021 | 24,600,175 | |||
Stock-based compensation | 1,009 | 1,009 | ||
Stock-based compensation, shares | ||||
Stock option exercises | 9 | 9 | ||
Stock option exercises,shares | 6,000 | |||
Net loss | (6,094) | (6,094) | ||
Balances at Sep. 30, 2021 | $ 25 | $ 110,787 | $ (95,152) | $ 15,660 |
Balance, shares at Sep. 30, 2021 | 24,606,175 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Cash flows from operating activities | ||
Net loss | $ (2,994) | $ (20,283) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | ||
Stock-based compensation | 2,518 | 1,803 |
Common stock issued for product candidate licensing rights | 1,264 | |
Depreciation and amortization | 325 | 490 |
Debt discount amortization | 110 | 85 |
Gain on forgiveness of debt | (365) | |
Gain on sale of equipment | (181) | |
Changes in operating assets and liabilities: | ||
Accounts receivable | (337) | 473 |
Inventories | 908 | (1,319) |
Prepaid expenses and other assets | (283) | 1,305 |
Accounts payable | 929 | 1,633 |
Accrued liabilities | (234) | (615) |
Net cash provided by (used in) operating activities | 396 | (15,164) |
Cash provided by (used in) investing activities | ||
Proceeds from sale of equipment | 700 | |
Purchases of property and equipment | (5) | (6) |
Net cash provided by (used in) financing activities | 695 | (6) |
Cash flows from financing activities | ||
Proceeds from sales of common stock, net of offering costs | 7,756 | |
Proceeds from issuance of long-term debt, net of issuance costs | 1,965 | |
EIDL loan payoff | (150) | |
Proceeds from PPP and EIDL loans | 511 | |
Proceeds from employee stock purchase plan and stock option exercises | 473 | 204 |
Net cash provided by financing activities | 323 | 10,436 |
Change in cash and cash equivalents | 1,414 | (4,734) |
Cash and cash equivalents at beginning of period | 21,295 | 12,066 |
Cash and cash equivalents at end of period | 22,709 | 7,332 |
Supplemental disclosures of cash flow information | ||
Cash paid for interest | 603 | 545 |
Cash paid for income taxes | ||
Supplemental disclosure of non-cash financing activity | ||
Relative fair value of warrants to purchase common stock issued in connection with debt | $ 94 |
Company Overview
Company Overview | 9 Months Ended |
Sep. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Company Overview | Note 1 — Company Overview Eton Pharmaceuticals, Inc. (“Eton” or the “Company”) was incorporated as a Delaware “C” corporation on April 27, 2017 and was initially set up as a wholly-owned subsidiary of Harrow Health, Inc. (“Harrow”, fka Imprimis Pharmaceuticals, Inc.). In June 2017, the Company raised $ 20,055 21,960 4,750 1,965 7,756 21,026 7.00 Eton is an innovative specialty pharmaceutical company focused on developing, acquiring, and commercializing treatments for rare diseases. The Company seeks to improve the formula, delivery system, or safety of existing molecules in order to address unmet patient needs. Eton pursues what it perceives to be low-risk product candidates where existing published literature, historical clinical trials, or physician usage has established safety and/or efficacy of the molecule, thereby reducing the incremental clinical burden required for the Company to bring the product to patients. The Company’s Biorphen® product was approved by the FDA in October 2019 and sales commenced for this product at the end of 2019. Eton’s EM-100 product was sold to Bausch Health and the product was approved by the FDA in September 2020. Bausch Health launched this product under the name of Alaway® Preservative Free in January 2021 and Eton receives royalties from the sale of the product. In addition, the Company acquired the licensing rights to Alkindi Sprinkle and this product was approved by the FDA in October 2020 and launched in December 2020. In February 2021, the Company sold three pediatric neurology products it had under development to Azurity Pharmaceuticals (“Azurity”) and anticipates additional revenues from Azurity based on various product-related milestones including the commercial launch for these products. One of the three products was approved by the FDA in November 2021 and two are currently under review with the FDA. In June 2021, the Company’s Rezipres product was approved by the FDA and is expected to launch in the coming months. In October 2021, the Company acquired the rights to an FDA-approved generic carglumic acid product indicated for the treatment of hyperammonemia due to N-acetylglutamate Synthase (NAGS) deficiency and it expects to launch this product late in 2021. The Company has three additional product candidates under development, two of which have been submitted to the FDA. |
Liquidity Considerations
Liquidity Considerations | 9 Months Ended |
Sep. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Liquidity Considerations | Note 2 — Liquidity Considerations During the first nine months of 2021, the Company generated net cash provided by operating activities of $ 396 primarily from the sale of three neurology products. The Company expects further growth in 2021 and beyond in accordance with additional market penetration from its approved products plus additional revenues from licensing and additional products where it anticipates FDA approval. Prior to 2021, the Company had generated limited revenues and had incurred negative cash flows from operating activities since its inception in 2017. The Company currently believes its existing cash and cash equivalents of $ 22,709 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Note 3 — Summary of Significant Accounting Policies Basis of Presentation The Company has prepared the accompanying financial statements in accordance with accounting principles generally accepted in the United States of America (“GAAP”). Eton Pharmaceuticals, Inc. Notes to Condensed Financial Statements ( in thousands, except share and per share amounts) (Unaudited) Note 3 — Summary of Significant Accounting Policies (continued) Unaudited Interim Financial Information The accompanying interim condensed financial statements are unaudited and have been prepared on the same basis as the audited financial statements and, in the opinion of management, reflect all adjustments necessary for the fair presentation of the Company’s financial position as of September 30, 2021 and the results of its operations and its cash flows for the periods ended September 30, 2021 and 2020. The financial data and other information disclosed in these notes related to the three and nine-month periods ended September 30, 2021 and 2020 are also unaudited. The results for the nine-month period ended September 30, 2021 are not necessarily indicative of results to be expected for the year ending December 31, 2021, any other interim periods or any future year or period. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenue and expenses during the reporting periods. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, provisions for uncollectible receivables and sales returns, valuation of inventories, useful lives of assets and the impairment of property and equipment, the accrual of research and development expenses and the valuation of common stock, stock options and warrants. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates or assumptions. Segment Information The Company operates the business on the basis of a single Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. All cash and cash equivalents are held in U.S. financial institutions or invested in short-term U.S. treasury bills or high-grade short-term money market accounts. From time to time, amounts deposited with its bank exceed federally insured limits and the Company believes the associated credit risk to be minimal. Accounts Receivable Accounts receivable are recorded at the invoiced amount and are non-interest bearing. Accounts receivable are recorded net of allowances for doubtful accounts, cash discounts for prompt payment, distribution fees, chargebacks and returns and allowances. The total for these reserves amounted to $ 91 71 Inventories The Company values its inventories at the lower of cost or net realizable value using the first-in, first-out method of valuation. The Company reviews its inventories for potential excess or obsolete issues on an ongoing basis and will record a write-down if an impairment is identified. During the three-month period ended September 30, 2021, the Company recorded a provision of $ 432 for excess quantities of its Biorphen product that are approaching expiration. Inventories at September 30, 2021 and December 31, 2020 consist solely of purchased finished goods. At September 30, 2021 and December 31, 2020, inventories are shown net of a slow-moving reserve for its Biorphen product of $ 1,414 and $ 623 , respectively, due to the risk of expiry before this entire stock of inventories is sold. Eton Pharmaceuticals, Inc. Notes to Condensed Financial Statements ( in thousands, except share and per share amounts) (Unaudited) Note 3 — Summary of Significant Accounting Policies (continued) Property and Equipment Property and equipment are stated at cost. Depreciation of property and equipment is computed utilizing the straight-line method based on the following estimated useful lives: computer hardware and software is depreciated over three years five years estimated useful lives or the remaining lease term Maintenance and repairs are charged to expense as incurred, while renewals and improvements are capitalized. In March 2021, the Company completed an evaluation of its expected needs for product development and testing activities and determined that it would discontinue its laboratory operation in Lake Zurich, Illinois. The Company completed a sale of the lab equipment in May 2021 at a price of $ 700 181 519 181 31 Intangible Assets The Company capitalizes payments it makes for licensed products when the payment is based on FDA approval for the product and the cost is recoverable based on expected future cash flows from the product. The cost is amortized on a straight-line basis over the estimated useful life of the product commencing on the approval date in accordance with Accounting Standards Codification (“ASC”) 350 — Intangibles - Goodwill and Other. A $ 750 cost is being amortized over five years. 287 37 112 150 125 Impairment of Long-Lived Assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized in the Company’s statements of operations for the amount by which the carrying amount of the asset exceeds the fair value of the asset. No Debt Issuance Costs and Debt Discount and Detachable Debt-Related Warrants Costs incurred to issue debt are deferred and recorded as a reduction to the debt balance in the accompanying balance sheets. The Company amortizes debt issuance costs over the expected term of the related debt using the effective interest method. Debt discounts relate to the relative fair value of warrants issued in conjunction with the debt and are also recorded as a reduction to the debt balance and accreted over the expected term of the debt to interest expense using the effective interest method. Revenue Recognition for Contracts with Customers The Company accounts for contracts with its customers in accordance with ASC 606 — Revenue from Contracts with Customers. ASC 606 applies to all contracts with customers, except for contracts that are within the scope of other standards. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. Eton Pharmaceuticals, Inc. Notes to Condensed Financial Statements ( in thousands, except share and per share amounts) (Unaudited) Note 3 — Summary of Significant Accounting Policies (continued) At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. The Company assesses whether these options provide a material right to the customer and, if so, they are considered performance obligations. The exercise of a material right is accounted for as a contract modification for accounting purposes. The Company recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) each performance obligation is satisfied at a point in time or over time, and if over time this is based on the use of an output or input method. Any amounts received prior to revenue recognition will be recorded as deferred revenue. Amounts expected to be recognized as revenue within the twelve months following the balance sheet date will be classified as current portion of deferred revenue in the Company’s balance sheets. Amounts not expected to be recognized as revenue within the twelve months following the balance sheet date are classified as long-term deferred revenue, net of current portion. Milestone Payments Royalties – Significant Financing Component – The Company sells Biorphen in the U.S. to wholesale pharmaceutical distributors, who then sell the product to hospitals and other end-user customers. Sales to wholesalers are made pursuant to purchase orders subject to the terms of a master agreement, and delivery of individual shipments of Biorphen represent performance obligations under each purchase order. The Company uses a third-party logistics (“3PL”) vendor to process and fulfill orders and has concluded it is the principal in the sales to wholesalers because it controls access to the 3PL vendor services rendered and directs the 3PL vendor activities. The Company has no significant obligations to wholesalers to generate pull-through sales. In addition, the Company sells its Alkindi Sprinkle product to one pharmacy distributor customer which provides order fulfilment and inventory storage/distribution services. Selling prices initially billed to wholesalers are subject to discounts for prompt payment and subsequent chargebacks when the wholesalers sell Biorphen at negotiated discounted prices to members of certain group purchasing organizations (“GPOs”) and government programs. In addition, the Company pays fees to wholesalers for their distribution services, inventory reporting and chargeback processing. The Company pays GPOs fees for administrative services and for access to GPO members and concluded the benefits received in exchange for these fees are not distinct from its sales of Biorphen, and accordingly it applies these amounts to reduce revenues. Wholesalers also have rights to return unsold product nearing or past the expiration date. Because of the shelf life of Biorphen and the Company’s lengthy return period, there may be a significant period of time between when the product is shipped and when it issues credits on returned product. For its Alkindi Sprinkle product, the Company bills at the initial product list price which are subject to offsets for patient co-pay assistance and potential state Medicaid reimbursements which are recorded as a reduction of net revenues at the date of sale/shipment. Eton Pharmaceuticals, Inc. Notes to Condensed Financial Statements ( in thousands, except share and per share amounts) (Unaudited) Note 3 — Summary of Significant Accounting Policies (continued) The Company estimates the transaction price when it receives each purchase order taking into account the expected reductions of the selling price initially billed to the wholesaler/distributor arising from all of the above factors. The Company has developed estimates for future returns and chargebacks of Biorphen and the impact of the other discounts and fees it pays while Alkindi Sprinkle sales to its distributor are not subject to returns. When estimating these adjustments to the transaction price, the Company reduces it sufficiently to be able to assert that it is probable that there will be no significant reversal of revenue when the ultimate adjustment amounts are known. The Company recognizes revenue from Biorphen product sales and related cost of sales upon product delivery to the wholesaler location. At that time, the wholesalers take control of the product as they take title, bear the risk of loss of ownership, and have an enforceable obligation to pay the Company. They also have the ability to direct sales of product to their customers on terms and at prices they negotiate. Although wholesalers have product return rights, the Company does not believe they have a significant incentive to return the product. The Company stores its Alkindi Sprinkle inventory at its pharmacy distributor customer location and sales are recorded when stock is pulled and shipped to fulfill specific patient orders. Upon recognition of revenue from product sales, the estimated amounts of credit for product returns, chargebacks, distribution fees, prompt payment discounts, state Medicaid and GPO fees are included in sales reserves, accrued liabilities and net of accounts receivable. The Company monitors actual product returns, chargebacks, discounts and fees subsequent to the sale. If these amounts end up differing from its estimates, it will make adjustments to these allowances, which are applied to increase or reduce product sales revenue and earnings in the period of adjustment. In addition, the Company receives revenues from product licensing agreements where it has contracted for milestone payments and royalties from products it has developed or for which it has acquired the rights to a product developed by a third party. Revenues for the three months ended September 30, 2021 reflected $ 734 41 14,000 1,481 258 Cost of Sales Cost of sales consists of the profit-sharing and royalty fees with the Company’s product licensing and development partners, the purchase costs for finished products from third-party manufacturers, write-downs for excess/obsolete inventory, and freight and handling/storage costs from the Company’s 3PL logistics service providers. The cost of sales for profit-sharing and royalty fees and costs for purchased finished products and the associated inbound freight expense is recorded when the associated product sale revenue is recognized in accordance with the terms of shipment to customers while outbound freight and handling/storage fees charged by the 3PL service provider are expensed as they are incurred. Cost of sales also reflects any write-downs or reserve adjustments for the Company’s inventories. Research and Development Expenses Research and development (“R&D”) expenses include both internal R&D activities and external contracted services. Internal R&D activity expenses include salaries, benefits and stock-based compensation and other costs to support the Company’s R&D operations. External contracted services include product development efforts such as certain product licensor milestone payments, clinical trial activities, manufacturing and control-related activities and regulatory costs. R&D expenses are charged to operations as incurred. The Company reviews and accrues R&D expenses based on services performed and relies upon estimates of those costs applicable to the stage of completion of each project. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. Upfront payments and milestone payments made for the licensing of technology for products that are not yet approved by the FDA are expensed as R&D in the period in which they are incurred. Nonrefundable advance payments for goods or services to be received in the future for use in R&D activities are recorded as prepaid expenses and are expensed as the related goods are delivered or the services are performed. Eton Pharmaceuticals, Inc. Notes to Condensed Financial Statements ( in thousands, except share and per share amounts) (Unaudited) Note 3 — Summary of Significant Accounting Policies (continued) Income (Loss) Per Share Basic net loss per common share is computed by dividing net loss for the period by the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing the net loss for the period by the weighted average number of common and common equivalent shares, such as unvested restricted stock awards (“RSA”), restricted stock units (“RSU’”), stock options and warrants, outstanding during the period. Common stock equivalents (using the treasury stock method) from stock options, unvested RSAs and RSUs, and warrants at September 30, 2021 and 2020 were 4,279,400 3,308,152 Basic weighted average shares for the three and nine months ended September 30, 2021 include 600,000 0.01 Stock-Based Compensation The Company accounts for stock-based compensation under the provisions of ASC 718 — Compensation — Stock Compensation. The guidance under ASC 718 requires companies to estimate the fair value of the stock-based compensation awards on the date of grant and record expense over the related service periods, which are generally the vesting period of the equity awards. The Company estimates the fair value of stock-based option awards using the Black-Scholes-Merton option-pricing model (“BSM”). The BSM requires the input of subjective assumptions, including the expected stock price volatility, the calculation of expected term, forfeitures and the fair value of the underlying common stock on the date of grant, among other inputs. The risk-free interest rate was determined from the implied yields for zero-coupon U.S. government issues with a remaining term approximating the expected life of the options or warrants. Dividends on common stock are assumed to be zero for the BSM valuation of the stock options. The expected term of stock options granted is based on vesting periods and the contractual life of the options. Expected volatilities are based on comparable companies’ historical volatility along with a limited weighting included for the Company’s own volatility subsequent to its IPO, which management believes represents the most accurate basis for estimating expected future volatility under the current conditions. The Company accounts for forfeitures as they occur. Fair Value Measurements We measure certain of our assets and liabilities at fair value. Fair value represents the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value accounting requires characterization of the inputs used to measure fair value into a three-level fair value hierarchy as follows: Level 1 Level 2 Level 3 Fair value measurements are classified based on the lowest level of input that is significant to the measurement. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment, which may affect the valuation of the assets and liabilities and their placement within the fair value hierarchy levels. The determination of the fair values stated below take into account the market for the Company’s financials, assets and liabilities, the associated credit risk and other factors as required. The Company considers active markets as those in which transactions for the assets or liabilities occur in sufficient frequency and volume to provide pricing information on an ongoing basis. Eton Pharmaceuticals, Inc. Notes to Condensed Financial Statements ( in thousands, except share and per share amounts) (Unaudited) Note 3 — Summary of Significant Accounting Policies (continued) The Company’s financial instruments included cash and cash equivalents, accounts receivable, accounts payable, accrued liabilities, and a long-term debt obligation. Based on borrowing rates currently available to the Company, the carrying amounts of these financial instruments, except for the long-term debt obligation, approximate their fair values due to the short-term maturities of these instruments. Impact of New Accounting Pronouncements There were no new accounting pronouncements issued by the FASB during the current period that would apply to the Company and have a material impact on its financial position or results of operations. |
Property and Equipment
Property and Equipment | 9 Months Ended |
Sep. 30, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Note 4 — Property and Equipment Property and equipment consist of the following: Schedule of Property and Equipment September 30, 2021 December 31, 2020 Computer hardware and software $ 155 $ 182 Furniture and fixtures 105 143 Equipment 132 994 Leasehold improvements 71 184 Property and equipment, gross 463 1,503 Less: accumulated depreciation (329 ) (692 ) Property and equipment, net $ 134 $ 811 Depreciation expense for the three-month periods ended September 30, 2021 and 2020 was $ 24 86 132 260 519 |
Long-Term Debt
Long-Term Debt | 9 Months Ended |
Sep. 30, 2021 | |
Debt Disclosure [Abstract] | |
Long-Term Debt | Note 5 — Long-Term Debt SWK Loan On November 13, 2019, the Company entered into a credit agreement (the “SWK Credit Agreement”) with SWK Holdings Corporation (“SWK”) which provided for up to $ 10,000 5,000 5,000 2,000 3,000 2,000 10.0 2.0% 2.0% 5.0% 3,000 Eton Pharmaceuticals, Inc. Notes to Condensed Financial Statements ( in thousands, except share and per share amounts) (Unaudited) Note 5 — Long Term Debt (continued) The SWK Credit Agreement contains customary default provisions and covenants which include limits on additional indebtedness. In March 2020, SWK provided a waiver for the Company to obtain loans with the Small Business Association. In February 2021, the Company notified SWK that it will not require additional borrowing capacity under the SWK Credit Agreement and terminated the additional borrowing capacity with SWK. In connection with the initial $ 5,000 51,239 5.86 226 5.75 seven 95 0 1.8 In connection with the additional $ 2,000 18,141 6.62 18,141 94 6.85 seven 95 0 0.4 These warrants (the “SWK Warrants”) are exercisable immediately and have a term of seven years from the date of issuance. The SWK Warrants contain a cashless exercise feature, with the exercise price and number of shares issuable upon exercise subject to change in connection with stock splits, dividends, reclassifications and other conditions. Interest expense of $ 766 110 617 85 107 The table below reflects the future payments for the SWK loan principal and interest as of September 30, 2021. Schedule of Future Payments of Long Term Debt Amount 2021 $ 212 2022 2,202 2023 1,756 2024 5,300 Total payments 9,470 Less: amount representing interest (2,470 ) Loan payable, gross 7,000 Less: current portion of long-term debt (1,092 ) Less: unamortized discount (358 ) Long-term debt, net of unamortized discount $ 5,550 PPP loan On May 4, 2020, the Company received $ 361 361 4 365 Eton Pharmaceuticals, Inc. Notes to Condensed Financial Statements ( in thousands, except share and per share amounts) (Unaudited) Note 5 — Long Term Debt (continued) EIDL loan On July 21, 2020, the Company received $ 150 6 |
Common Stock
Common Stock | 9 Months Ended |
Sep. 30, 2021 | |
Equity [Abstract] | |
Common Stock | Note 6 — Common Stock The Company has 50,000,000 0.001 During the nine months ended September 30, 2021, the Company issued 144,233 25,000 During the nine months ended September 30, 2021, a holder of the Company’s common stock warrants exercised 135,650 94,808 806 In June 2021, the Company issued 29,326 |
Common Stock Warrants
Common Stock Warrants | 9 Months Ended |
Sep. 30, 2021 | |
Common Stock Warrants | |
Common Stock Warrants | Note 7 — Common Stock Warrants The Company’s outstanding warrants to purchase shares of its common stock at September 30, 2021 are summarized in the table below. Summary of Warrants Outstanding Description of Warrants No. of Shares Exercise Price Business Advisory Warrants 600,000 $ 0.01 Placement Agent Warrants – 2017 Preferred Stock Offering 471,446 $ 3.00 Placement Agent Warrants - IPO 414,000 $ 7.50 SWK Warrants – Debt – Tranche #1 51,239 $ 5.86 SWK Warrants – Debt – Tranche #2 18,141 $ 6.62 Total 1,554,826 $ 3.18 (Avg) The holders of these warrants or their permitted transferees, are entitled to rights with respect to the registration under the Securities Act of 1933, as amended (the “Securities Act”) for their shares that are converted to common stock, including demand registration rights and piggyback registration rights. These rights are provided under the terms of a registration rights agreement between the Company and the investors. Eton Pharmaceuticals, Inc. Notes to Condensed Financial Statements ( in thousands, except share and per share amounts) (Unaudited) |
Share-Based Payment Awards
Share-Based Payment Awards | 9 Months Ended |
Sep. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Share-Based Payment Awards | Note 8 — Share-Based Payment Awards The Company’s board of directors and stockholders approved the Eton Pharmaceuticals, Inc. 2017 Equity Incentive Plan in May 2017 (the “2017 Plan”), which authorized the issuance of up to 5,000,000 481,160 Shares that are expired, terminated, surrendered or canceled without having been fully exercised will be available for future awards under the 2018 Plan. In addition, the 2018 Plan provides that commencing January 1, 2019 and through January 1, 2028, the share reserve will be increased annually by 4% During the third quarter of 2017, the Company issued 25,000 100,000 100 25,000 To date, all stock options issued have been non-qualified stock options, and the exercise prices were set at the fair value for the shares at the dates of grant. Options typically have a ten 50,000 five years For the three months ended September 30, 2021 and 2020, the Company’s total stock-based compensation expense was $ 1,009 and $ 724 , respectively. Of these amounts, $ 838 and $ 647, respectively, was recorded in general and administrative expenses, and $ 171 and $ 77, respectively, was recorded in research and development expenses. For the nine months ended September 30, 2021 and 2020, the Company’s total stock-based compensation expense was $ 2,518 and $ 1,803 , respectively. Of these amounts, $ 2,110 and $ 1,623 , respectively, was recorded in general and administrative expenses, and $ 408 and $ 180, respectively, was recorded in research and development expenses. Eton Pharmaceuticals, Inc. Notes to Condensed Financial Statements ( in thousands, except share and per share amounts) (Unaudited) Note 8 — Share-Based Payment Awards (continued) A summary of stock option activity is as follows: Summary of Stock Option Activity Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Yrs) Aggregate Intrinsic Value Options outstanding as of December 31, 2020 2,824,500 $ 4.05 8.3 $ 11,525 Issued 902,098 $ 8.61 Exercised (144,233 ) $ 2.35 Forfeited/Cancelled (12,500 ) $ 7.31 Options outstanding as of September 30, 2021 3,569,865 $ 5.26 8.1 $ 4,167 Options exercisable at September 30, 2021 1,734,652 $ 4.00 7.4 $ 2,961 Options vested and expected to vest at September 30, 2021 3,519,865 $ 5.31 8.1 $ 3,984 The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had strike prices lower than the fair value of the Company’s common stock at period end. The assumptions used to calculate the fair value of options granted during the nine months ended September 30, 2021 under the BSM were as follows: Schedule of Assumptions Used to Calculate Fair Value of Options Granted Expected dividends — % Expected volatility 80 % Risk-free interest rate 0.9 1.1 % Expected term 5.3 6.3 Weighted average fair value $ 5.88 Expected Term — The Company has opted to use the “simplified method” for estimating the expected term of options granted to employees and directors, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the option (generally ten years). The expected term of options granted to non-employees equals the contractual life of the options. Expected Volatility — Due to the Company’s limited operating history and a lack of Company-specific historical and implied volatility data, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. The Company has continued this methodology plus given some limited weighting to its own volatility in the periods subsequent to its November 2018 IPO. The historical volatility data was computed using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of the stock-based awards. Risk-Free Interest Rate — The risk-free rate assumption is based on the U.S. Treasury instruments with maturities similar to the expected term of the Company’s stock options. Expected Dividend — The Company has not issued any dividends in its history and does not expect to issue dividends over the life of the options and therefore has estimated the dividend yield to be zero Fair Value of Common Stock —The Company uses the closing stock price on the date of grant for the fair value of the common stock. Eton Pharmaceuticals, Inc. Notes to Condensed Financial Statements ( in thousands, except share and per share amounts) (Unaudited) Note 8 — Share-Based Payment Awards (continued) As of September 30, 2021, there was a total of $ 7,270 of unrecognized compensation costs related to non-vested stock option and restricted awards. During the nine-month period ended September 30, 2021, there were five stock option exercises which totaled 144,233 shares at an average exercise price of $ 2.35 per share with an intrinsic value of $ 682 . There were six stock option exercises for 102,378 shares during the nine months ended September 30, 2020 at an average exercise price of $ 1.37 per share with an intrinsic value of $ 436 . In December 2018, the Company’s board of directors approved and adopted an initial offering of the Company’s common stock under the Company’s 2018 ESPP. The Company’s ESPP provides for an initial reserve of 150,000 500,009 The initial offering of the ESPP began on December 17, 2018 and ended on December 10, 2019. The annual offerings consist of two stock purchase periods, with the first purchase period ending in June and the second purchase period ending in December. The terms of the ESPP permit employees of the Company to use payroll deductions to purchase stock at a price per share that is at least the lesser of (1) 85% of the fair market value of a share of common stock on the first date of an offering or (2) 85% of the fair market value of a share of common stock on the date of purchase. After the initial offering period ended, subsequent twelve-month offering periods automatically commence over the term of the ESPP on the day that immediately follows the conclusion of the preceding offering, each consisting of two purchase periods approximately six months in duration For the first nine months of 2021 and 2020 there were 29,326 14,005 2.83 2.43 192 100 83 38 77 19 |
Earnings (Loss) Per Share
Earnings (Loss) Per Share | 9 Months Ended |
Sep. 30, 2021 | |
Earnings Per Share [Abstract] | |
Earnings (Loss) Per Share | Note 9 — Earnings (Loss) Per Share Basic and diluted net income (loss) per share was calculated as follows: Schedule of Basic and Diluted Net Income (Loss) Per Share 2021 2020 2021 2020 Three months ended September 30, Nine months ended September 30, 2021 2020 2021 2020 Basic net loss per share: Numerator: Net loss $ (6,094 ) $ (6,504 ) $ (2,994 ) $ (20,283 ) Denominator: Weighted-average number of common shares outstanding, basic and diluted 25,276,153 21,052,174 25,181,095 20,070,430 Net loss per share, basic and diluted $ (0.24 ) $ (0.31 ) $ (0.12 ) $ (1.01 ) There was no difference between the Company’s net loss and the net loss attributable to common stockholders for all periods presented. Eton Pharmaceuticals, Inc. Notes to Condensed Financial Statements ( in thousands, except share and per share amounts) (Unaudited) |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2021 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Note 10 — Related Party Transactions Harrow Harrow was issued 3,500,000 shares of the Company’s common stock at the formation of the Company at the $ 0.001 par value per share price as the paid-in-capital contribution from Harrow. In April 2021, Harrow sold 1,518,000 1,982,000 On May 6, 2019, the Company entered into an Asset Purchase Agreement (the “CT-100 Asset Purchase Agreement”) with Harrow. Pursuant to the CT-100 Asset Purchase Agreement, the Company sold all of its right, title and interest in CT-100 to Harrow, including any such product that incorporates or utilizes its intellectual property rights (a “Product” or, collectively, “Products”). Pursuant to the CT-100 Asset Purchase Agreement, Harrow will make certain payments to the Company upon the achievement of certain development and commercial milestones. In addition, Harrow is required to pay the Company a royalty in the low-single digit percentage range worldwide on a country-by-country basis on net sales for a period of the longer of 15 years from the date of the first commercial sale of a product in a particular country or the time that a valid intellectual property claim on such Product remains in force in the applicable country. The CT-100 Asset Purchase Agreement also contains customary representations, warranties, covenants and indemnities by the parties. To date there have not been any sales of the CT-100 product and therefore no earned royalties to the Company for this product. As part of the early start-up for the Company’s pharmaceutical business in 2017, key executives at Harrow received a total of 1,500,000 130,000 20,000 Additionally, the Chief Executive Officer of Harrow was a member of the Company’s board of directors until March 17, 2021 when he retired from service with the board. The Company issued 25,000 In late March 2021, the Company closed its laboratory operation in Lake Zurich, Illinois and in May 2021 it reached an agreement for Imprimis Pharmaceuticals, a subsidiary of Harrow, to purchase its lab equipment for $ 700 181 Eton Pharmaceuticals, Inc. Notes to Condensed Financial Statements ( in thousands, except share and per share amounts) (Unaudited) Note 10 — Related Party Transactions (continued) Chief Executive Officer The CEO has a partial interest in a company that the Company has partnered with for its EM-100 product as described below. The Company acquired the exclusive rights to sell the EM-100 product in the United States pursuant to a sales and marketing agreement (the “Eyemax Agreement”) dated August 11, 2017 between the Company and Eyemax LLC (“Eyemax”), an entity affiliated with the Company’s CEO. The Company also held a right of first refusal to obtain the exclusive license rights for geographic areas outside of the United States. Pursuant to the Eyemax Agreement, the Company was responsible for all costs of testing and FDA approval of the product, other than the FDA filing fee which was paid by Eyemax. The Company was also to be responsible for commercializing the product in the United States at its expense. The Company paid Eyemax $ 250 250 500 10 The Eyemax Agreement was for an initial term of 10 years On February 18, 2019, The Company entered into an Amended and Restated Agreement with Eyemax amending the Eyemax Agreement (the “Amended Agreement”). Pursuant to the Amended Agreement, Eyemax sold the Company all of its right, title and interest in EM-100, including any such product that incorporates or utilizes Eyemax’s intellectual property rights. Under the Amended Agreement, the Company assumed certain liabilities of Eyemax under its Exclusive Development & Supply Agreement with Excelvision SAS dated as of July 11, 2013, as amended (the “Excelvision Agreement”), with respect to certain territories and arising during certain time periods. Pursuant to the Amended Agreement, the Company was obligated to pay Eyemax two milestone payments: (i) one milestone payment for $ 250 500 2,000 Eton Pharmaceuticals, Inc. Notes to Condensed Financial Statements ( in thousands, except share and per share amounts) (Unaudited) |
Leases
Leases | 9 Months Ended |
Sep. 30, 2021 | |
Leases | |
Leases | Note 11 — Leases The Company recognizes a right-of-use (“ROU”) asset and a lease liability on the balance sheet for substantially all leases, including operating leases, and separates lease components from non-lease components related to its office space lease. The Company’s operating lease cost as presented in the “Research and Development” and “General and Administrative” captions in the condensed statements of operations was $ 0 21 13 21 9 64 41 62 63 20 69 33 97 1.50 years 5.4 The table below presents the lease-related assets and liabilities recorded on the balance sheet as of September 30, 2021 (in thousands). Schedule of Lease-related Assets and Liabilities Assets Classification Operating lease right-of-use assets Operating lease right-of-use assets, net $ 123 Total leased assets $ 123 Liabilities Operating lease liabilities, current Accrued liabilities $ 83 Operating lease liabilities, noncurrent Operating lease liabilities, net of current portion 36 Total operating lease liabilities $ 119 The Company’s future lease commitments for its administrative offices in Deer Park, Illinois as of September 30, 2021 are as indicated below: Schedule of Future Lease Commitments Total 2021 2022 2023 Thereafter Undiscounted lease payments $ 124 22 88 14 — Less: Imputed interest (5 ) Total lease liabilities $ 119 Eton Pharmaceuticals, Inc. Notes to Condensed Financial Statements ( in thousands, except share and per share amounts) (Unaudited) |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 12 — Commitments and Contingencies Legal The Company is subject to legal proceedings and claims that may arise in the ordinary course of business. The Company is not aware of any pending or threatened litigation matters at this time that may have a material impact on the operations of the Company. License and product development agreements The Company has entered into various agreements in addition to those discussed above which are described below. The Company acquired the exclusive rights to sell the Cysteine injection product in the United States pursuant to a sales and marketing agreement dated November 17, 2017 with an unaffiliated third party (the “Sales Agreement”). Pursuant to the Sales Agreement, the licensor is responsible for obtaining FDA approval, at its expense, and the Company is responsible for commercializing the product in the United States at its expense. The Company was to pay the third party 50 62.5 10 years On February 8, 2019, the Company entered into an Exclusive Licensing and Supply Agreement (the “ET-202 License Agreement”) with Sintetica SA (“Sintetica”) for marketing rights in the United States to Biorphen® which is used for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia. The product was submitted to the FDA for review and subsequently received FDA approval on October 21, 2019. Pursuant to the terms of the ET-202 License Agreement, the Company is responsible for marketing activities and Sintetica is responsible for development, manufacturing, and the regulatory activities related to approval. The Company paid Sintetica a licensing payment of $ 2,000 750 5 500 50 50 ten On February 8, 2019, the Company also entered into an Exclusive Licensing and Supply Agreement (the “ET-203 License Agreement”) with Sintetica for marketing rights in the United States to ephedrine (brand name Rezipres®), an injectable product candidate for use in the hospital setting. Pursuant to the terms of the ET-203 License Agreement, the Company will be responsible for marketing activities and Sintetica will be responsible for development, manufacturing, and regulatory activities related to obtaining regulatory approval. The Company paid Sintetica a licensing payment of $ 1,000 600 750 5 500 50 50 ten-year The three oral solution pediatric neurology product candidates discussed below, Topiramate, Zonisamide and Lamotrigine were developed by the Company and its various product candidate development partners and the Company subsequently sold all its rights and interests in these three products to Azurity Pharmaceuticals, Inc. (“Azurity”) in 2021. During the years ended December 31, 2020, 2019 and 2018, the Company worked with Tulex Pharmaceuticals, Inc. (“Tulex”) as a third-party contract manufacturer to develop an oral solution for Topiramate (fka ET-101) which targets a neurological condition. The Company subsequently filed the product with the FDA in October 2020 and paid a $ 1,438 Eton Pharmaceuticals, Inc. Notes to Condensed Financial Statements ( in thousands, except share and per share amounts) (Unaudited) Note 12 — Commitments and Contingencies (continued) On January 23, 2019, the Company entered into a Licensing and Supply Agreement (the “Agreement”) with Liqmeds Worldwide Limited (“LMW”) for Zonisamide oral liquid, a development stage product candidate (“ET-104”). Pursuant to the terms of the Agreement, the Company was to be responsible for regulatory and marketing activities. LMW will be responsible for development and manufacturing of ET-104. The Company paid the licensor $ 350 350 325 325 650 500 10,000 35 10 years On June 12, 2019, the Company entered into an Exclusive Licensing and Supply Agreement (the “ET-105 License Agreement”) with Aucta Pharmaceuticals, Inc. (“Aucta”) for marketing rights in the United States to Lamotrigine, an oral suspension product candidate for use as an adjunct therapy for partial seizures, primary generalized tonic-clonic seizures, and generalized seizures of Lennox-Gastaut syndrome in patients two years of age and older. Pursuant to the terms of the ET-105 License Agreement, the Company was to be responsible for marketing activities and Aucta will be responsible for development, manufacturing, and regulatory activities related to obtaining regulatory approval. The Company paid Aucta a licensing payment of $ 2,000 2,450 1,000 1,500 1,950 18,000 ● $ 1,000 when net sales exceed $10 million in a calendar year ● $ 2,000 when net sales exceed $20 million in a calendar year ● $ 5,000 when net sales exceed $50 million in a calendar year ● $ 10,000 when net sales exceed $100 million in a calendar year Eton will remain responsible for certain licensing fee obligations owed to its development partners and Azurity will assume royalty or profit share obligations owed to development partners. On March 27, 2020, the Company entered into an Exclusive Licensing and Supply Agreement (the “Alkindi License Agreement”) with Diurnal Limited (“Diurnal”) for marketing Alkindi Sprinkle in the United States. Alkindi Sprinkle’s New Drug Application (NDA) was approved by the FDA on September 29, 2020 as a replacement therapy for pediatric adrenal insufficiency (AI), including congenital adrenal hyperplasia (CAH) in patients from birth to less than 17 years of age. For the initial licensing milestone fee, the Company paid Diurnal $ 3,500 in cash and issued 379,474 shares of its common stock to Diurnal which were valued at $ 1,264 based on the Company’s closing stock price of $ 3.33 on March 26, 2020. The total amount of $ 4,764 was recorded as a component of research and development expense in the Company’s statement of operations for the nine months ended September 30, 2020. The Company pays Diurnal a low double-digit royalty on its sales of Alkindi Sprinkle and will also pay Diurnal $ 2,500 if the product obtains orphan drug exclusivity status from the FDA. On June 15, 2021, the Company entered into a Distribution and Promotion License Agreement with Crossject S.A. (“Crossject”) for the U.S. and Canadian rights to Crossject’s ZENEO ® 500 500 1,500 2,000 6,000 Eton Pharmaceuticals, Inc. Notes to Condensed Financial Statements ( in thousands, except share and per share amounts) (Unaudited) |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | Note 13 — Subsequent Events On October 27, 2021, the Company entered into a license agreement for a generic carglumic acid product which is used to treat hyperammonemia due to N- acetylglutamate Synthase (NAGS) deficiency. The Company paid $ 3,250 50 On November 12, 2021, the Company entered into a multi-year agreement with Tolmar Pharmaceuticals, Inc. (“Tolmar”) to co-promote the Company’s Alkindi Sprinkle® product. The Company will leverage Tolmar’s 62-person sales force and their existing relationships in the pediatric endocrinology specialty. Tolmar will receive a royalty on net sales growth above the Company’s current baseline sales for Alkindi Sprinkle. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The Company has prepared the accompanying financial statements in accordance with accounting principles generally accepted in the United States of America (“GAAP”). Eton Pharmaceuticals, Inc. Notes to Condensed Financial Statements ( in thousands, except share and per share amounts) (Unaudited) Note 3 — Summary of Significant Accounting Policies (continued) |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The accompanying interim condensed financial statements are unaudited and have been prepared on the same basis as the audited financial statements and, in the opinion of management, reflect all adjustments necessary for the fair presentation of the Company’s financial position as of September 30, 2021 and the results of its operations and its cash flows for the periods ended September 30, 2021 and 2020. The financial data and other information disclosed in these notes related to the three and nine-month periods ended September 30, 2021 and 2020 are also unaudited. The results for the nine-month period ended September 30, 2021 are not necessarily indicative of results to be expected for the year ending December 31, 2021, any other interim periods or any future year or period. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of revenue and expenses during the reporting periods. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, provisions for uncollectible receivables and sales returns, valuation of inventories, useful lives of assets and the impairment of property and equipment, the accrual of research and development expenses and the valuation of common stock, stock options and warrants. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. Actual results could differ from those estimates or assumptions. |
Segment Information | Segment Information The Company operates the business on the basis of a single |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents. All cash and cash equivalents are held in U.S. financial institutions or invested in short-term U.S. treasury bills or high-grade short-term money market accounts. From time to time, amounts deposited with its bank exceed federally insured limits and the Company believes the associated credit risk to be minimal. |
Accounts Receivable | Accounts Receivable Accounts receivable are recorded at the invoiced amount and are non-interest bearing. Accounts receivable are recorded net of allowances for doubtful accounts, cash discounts for prompt payment, distribution fees, chargebacks and returns and allowances. The total for these reserves amounted to $ 91 71 |
Inventories | Inventories The Company values its inventories at the lower of cost or net realizable value using the first-in, first-out method of valuation. The Company reviews its inventories for potential excess or obsolete issues on an ongoing basis and will record a write-down if an impairment is identified. During the three-month period ended September 30, 2021, the Company recorded a provision of $ 432 for excess quantities of its Biorphen product that are approaching expiration. Inventories at September 30, 2021 and December 31, 2020 consist solely of purchased finished goods. At September 30, 2021 and December 31, 2020, inventories are shown net of a slow-moving reserve for its Biorphen product of $ 1,414 and $ 623 , respectively, due to the risk of expiry before this entire stock of inventories is sold. Eton Pharmaceuticals, Inc. Notes to Condensed Financial Statements ( in thousands, except share and per share amounts) (Unaudited) Note 3 — Summary of Significant Accounting Policies (continued) |
Property and Equipment | Property and Equipment Property and equipment are stated at cost. Depreciation of property and equipment is computed utilizing the straight-line method based on the following estimated useful lives: computer hardware and software is depreciated over three years five years estimated useful lives or the remaining lease term Maintenance and repairs are charged to expense as incurred, while renewals and improvements are capitalized. In March 2021, the Company completed an evaluation of its expected needs for product development and testing activities and determined that it would discontinue its laboratory operation in Lake Zurich, Illinois. The Company completed a sale of the lab equipment in May 2021 at a price of $ 700 181 519 181 31 |
Intangible Assets | Intangible Assets The Company capitalizes payments it makes for licensed products when the payment is based on FDA approval for the product and the cost is recoverable based on expected future cash flows from the product. The cost is amortized on a straight-line basis over the estimated useful life of the product commencing on the approval date in accordance with Accounting Standards Codification (“ASC”) 350 — Intangibles - Goodwill and Other. A $ 750 cost is being amortized over five years. 287 37 112 150 125 |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash flows, an impairment charge is recognized in the Company’s statements of operations for the amount by which the carrying amount of the asset exceeds the fair value of the asset. No |
Debt Issuance Costs and Debt Discount and Detachable Debt-Related Warrants | Debt Issuance Costs and Debt Discount and Detachable Debt-Related Warrants Costs incurred to issue debt are deferred and recorded as a reduction to the debt balance in the accompanying balance sheets. The Company amortizes debt issuance costs over the expected term of the related debt using the effective interest method. Debt discounts relate to the relative fair value of warrants issued in conjunction with the debt and are also recorded as a reduction to the debt balance and accreted over the expected term of the debt to interest expense using the effective interest method. |
Revenue Recognition for Contracts with Customers | Revenue Recognition for Contracts with Customers The Company accounts for contracts with its customers in accordance with ASC 606 — Revenue from Contracts with Customers. ASC 606 applies to all contracts with customers, except for contracts that are within the scope of other standards. Under ASC 606, an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. Eton Pharmaceuticals, Inc. Notes to Condensed Financial Statements ( in thousands, except share and per share amounts) (Unaudited) Note 3 — Summary of Significant Accounting Policies (continued) At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered options. The Company assesses whether these options provide a material right to the customer and, if so, they are considered performance obligations. The exercise of a material right is accounted for as a contract modification for accounting purposes. The Company recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) each performance obligation is satisfied at a point in time or over time, and if over time this is based on the use of an output or input method. Any amounts received prior to revenue recognition will be recorded as deferred revenue. Amounts expected to be recognized as revenue within the twelve months following the balance sheet date will be classified as current portion of deferred revenue in the Company’s balance sheets. Amounts not expected to be recognized as revenue within the twelve months following the balance sheet date are classified as long-term deferred revenue, net of current portion. Milestone Payments Royalties – Significant Financing Component – The Company sells Biorphen in the U.S. to wholesale pharmaceutical distributors, who then sell the product to hospitals and other end-user customers. Sales to wholesalers are made pursuant to purchase orders subject to the terms of a master agreement, and delivery of individual shipments of Biorphen represent performance obligations under each purchase order. The Company uses a third-party logistics (“3PL”) vendor to process and fulfill orders and has concluded it is the principal in the sales to wholesalers because it controls access to the 3PL vendor services rendered and directs the 3PL vendor activities. The Company has no significant obligations to wholesalers to generate pull-through sales. In addition, the Company sells its Alkindi Sprinkle product to one pharmacy distributor customer which provides order fulfilment and inventory storage/distribution services. Selling prices initially billed to wholesalers are subject to discounts for prompt payment and subsequent chargebacks when the wholesalers sell Biorphen at negotiated discounted prices to members of certain group purchasing organizations (“GPOs”) and government programs. In addition, the Company pays fees to wholesalers for their distribution services, inventory reporting and chargeback processing. The Company pays GPOs fees for administrative services and for access to GPO members and concluded the benefits received in exchange for these fees are not distinct from its sales of Biorphen, and accordingly it applies these amounts to reduce revenues. Wholesalers also have rights to return unsold product nearing or past the expiration date. Because of the shelf life of Biorphen and the Company’s lengthy return period, there may be a significant period of time between when the product is shipped and when it issues credits on returned product. For its Alkindi Sprinkle product, the Company bills at the initial product list price which are subject to offsets for patient co-pay assistance and potential state Medicaid reimbursements which are recorded as a reduction of net revenues at the date of sale/shipment. Eton Pharmaceuticals, Inc. Notes to Condensed Financial Statements ( in thousands, except share and per share amounts) (Unaudited) Note 3 — Summary of Significant Accounting Policies (continued) The Company estimates the transaction price when it receives each purchase order taking into account the expected reductions of the selling price initially billed to the wholesaler/distributor arising from all of the above factors. The Company has developed estimates for future returns and chargebacks of Biorphen and the impact of the other discounts and fees it pays while Alkindi Sprinkle sales to its distributor are not subject to returns. When estimating these adjustments to the transaction price, the Company reduces it sufficiently to be able to assert that it is probable that there will be no significant reversal of revenue when the ultimate adjustment amounts are known. The Company recognizes revenue from Biorphen product sales and related cost of sales upon product delivery to the wholesaler location. At that time, the wholesalers take control of the product as they take title, bear the risk of loss of ownership, and have an enforceable obligation to pay the Company. They also have the ability to direct sales of product to their customers on terms and at prices they negotiate. Although wholesalers have product return rights, the Company does not believe they have a significant incentive to return the product. The Company stores its Alkindi Sprinkle inventory at its pharmacy distributor customer location and sales are recorded when stock is pulled and shipped to fulfill specific patient orders. Upon recognition of revenue from product sales, the estimated amounts of credit for product returns, chargebacks, distribution fees, prompt payment discounts, state Medicaid and GPO fees are included in sales reserves, accrued liabilities and net of accounts receivable. The Company monitors actual product returns, chargebacks, discounts and fees subsequent to the sale. If these amounts end up differing from its estimates, it will make adjustments to these allowances, which are applied to increase or reduce product sales revenue and earnings in the period of adjustment. In addition, the Company receives revenues from product licensing agreements where it has contracted for milestone payments and royalties from products it has developed or for which it has acquired the rights to a product developed by a third party. Revenues for the three months ended September 30, 2021 reflected $ 734 41 14,000 1,481 258 |
Cost of Sales | Cost of Sales Cost of sales consists of the profit-sharing and royalty fees with the Company’s product licensing and development partners, the purchase costs for finished products from third-party manufacturers, write-downs for excess/obsolete inventory, and freight and handling/storage costs from the Company’s 3PL logistics service providers. The cost of sales for profit-sharing and royalty fees and costs for purchased finished products and the associated inbound freight expense is recorded when the associated product sale revenue is recognized in accordance with the terms of shipment to customers while outbound freight and handling/storage fees charged by the 3PL service provider are expensed as they are incurred. Cost of sales also reflects any write-downs or reserve adjustments for the Company’s inventories. |
Research and Development Expenses | Research and Development Expenses Research and development (“R&D”) expenses include both internal R&D activities and external contracted services. Internal R&D activity expenses include salaries, benefits and stock-based compensation and other costs to support the Company’s R&D operations. External contracted services include product development efforts such as certain product licensor milestone payments, clinical trial activities, manufacturing and control-related activities and regulatory costs. R&D expenses are charged to operations as incurred. The Company reviews and accrues R&D expenses based on services performed and relies upon estimates of those costs applicable to the stage of completion of each project. Significant judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. Upfront payments and milestone payments made for the licensing of technology for products that are not yet approved by the FDA are expensed as R&D in the period in which they are incurred. Nonrefundable advance payments for goods or services to be received in the future for use in R&D activities are recorded as prepaid expenses and are expensed as the related goods are delivered or the services are performed. Eton Pharmaceuticals, Inc. Notes to Condensed Financial Statements ( in thousands, except share and per share amounts) (Unaudited) Note 3 — Summary of Significant Accounting Policies (continued) |
Income (Loss) Per Share | Income (Loss) Per Share Basic net loss per common share is computed by dividing net loss for the period by the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing the net loss for the period by the weighted average number of common and common equivalent shares, such as unvested restricted stock awards (“RSA”), restricted stock units (“RSU’”), stock options and warrants, outstanding during the period. Common stock equivalents (using the treasury stock method) from stock options, unvested RSAs and RSUs, and warrants at September 30, 2021 and 2020 were 4,279,400 3,308,152 Basic weighted average shares for the three and nine months ended September 30, 2021 include 600,000 0.01 |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for stock-based compensation under the provisions of ASC 718 — Compensation — Stock Compensation. The guidance under ASC 718 requires companies to estimate the fair value of the stock-based compensation awards on the date of grant and record expense over the related service periods, which are generally the vesting period of the equity awards. The Company estimates the fair value of stock-based option awards using the Black-Scholes-Merton option-pricing model (“BSM”). The BSM requires the input of subjective assumptions, including the expected stock price volatility, the calculation of expected term, forfeitures and the fair value of the underlying common stock on the date of grant, among other inputs. The risk-free interest rate was determined from the implied yields for zero-coupon U.S. government issues with a remaining term approximating the expected life of the options or warrants. Dividends on common stock are assumed to be zero for the BSM valuation of the stock options. The expected term of stock options granted is based on vesting periods and the contractual life of the options. Expected volatilities are based on comparable companies’ historical volatility along with a limited weighting included for the Company’s own volatility subsequent to its IPO, which management believes represents the most accurate basis for estimating expected future volatility under the current conditions. The Company accounts for forfeitures as they occur. |
Fair Value Measurements | Fair Value Measurements We measure certain of our assets and liabilities at fair value. Fair value represents the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Fair value accounting requires characterization of the inputs used to measure fair value into a three-level fair value hierarchy as follows: Level 1 Level 2 Level 3 Fair value measurements are classified based on the lowest level of input that is significant to the measurement. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment, which may affect the valuation of the assets and liabilities and their placement within the fair value hierarchy levels. The determination of the fair values stated below take into account the market for the Company’s financials, assets and liabilities, the associated credit risk and other factors as required. The Company considers active markets as those in which transactions for the assets or liabilities occur in sufficient frequency and volume to provide pricing information on an ongoing basis. Eton Pharmaceuticals, Inc. Notes to Condensed Financial Statements ( in thousands, except share and per share amounts) (Unaudited) Note 3 — Summary of Significant Accounting Policies (continued) The Company’s financial instruments included cash and cash equivalents, accounts receivable, accounts payable, accrued liabilities, and a long-term debt obligation. Based on borrowing rates currently available to the Company, the carrying amounts of these financial instruments, except for the long-term debt obligation, approximate their fair values due to the short-term maturities of these instruments. |
Impact of New Accounting Pronouncements | Impact of New Accounting Pronouncements There were no new accounting pronouncements issued by the FASB during the current period that would apply to the Company and have a material impact on its financial position or results of operations. |
Property and Equipment (Tables)
Property and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consist of the following: Schedule of Property and Equipment September 30, 2021 December 31, 2020 Computer hardware and software $ 155 $ 182 Furniture and fixtures 105 143 Equipment 132 994 Leasehold improvements 71 184 Property and equipment, gross 463 1,503 Less: accumulated depreciation (329 ) (692 ) Property and equipment, net $ 134 $ 811 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Future Payments of Long Term Debt | The table below reflects the future payments for the SWK loan principal and interest as of September 30, 2021. Schedule of Future Payments of Long Term Debt Amount 2021 $ 212 2022 2,202 2023 1,756 2024 5,300 Total payments 9,470 Less: amount representing interest (2,470 ) Loan payable, gross 7,000 Less: current portion of long-term debt (1,092 ) Less: unamortized discount (358 ) Long-term debt, net of unamortized discount $ 5,550 |
Common Stock Warrants (Tables)
Common Stock Warrants (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Common Stock Warrants | |
Summary of Warrants Outstanding | The Company’s outstanding warrants to purchase shares of its common stock at September 30, 2021 are summarized in the table below. Summary of Warrants Outstanding Description of Warrants No. of Shares Exercise Price Business Advisory Warrants 600,000 $ 0.01 Placement Agent Warrants – 2017 Preferred Stock Offering 471,446 $ 3.00 Placement Agent Warrants - IPO 414,000 $ 7.50 SWK Warrants – Debt – Tranche #1 51,239 $ 5.86 SWK Warrants – Debt – Tranche #2 18,141 $ 6.62 Total 1,554,826 $ 3.18 (Avg) |
Share-Based Payment Awards (Tab
Share-Based Payment Awards (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Stock Option Activity | A summary of stock option activity is as follows: Summary of Stock Option Activity Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Yrs) Aggregate Intrinsic Value Options outstanding as of December 31, 2020 2,824,500 $ 4.05 8.3 $ 11,525 Issued 902,098 $ 8.61 Exercised (144,233 ) $ 2.35 Forfeited/Cancelled (12,500 ) $ 7.31 Options outstanding as of September 30, 2021 3,569,865 $ 5.26 8.1 $ 4,167 Options exercisable at September 30, 2021 1,734,652 $ 4.00 7.4 $ 2,961 Options vested and expected to vest at September 30, 2021 3,519,865 $ 5.31 8.1 $ 3,984 |
Schedule of Assumptions Used to Calculate Fair Value of Options Granted | The assumptions used to calculate the fair value of options granted during the nine months ended September 30, 2021 under the BSM were as follows: Schedule of Assumptions Used to Calculate Fair Value of Options Granted Expected dividends — % Expected volatility 80 % Risk-free interest rate 0.9 1.1 % Expected term 5.3 6.3 Weighted average fair value $ 5.88 |
Earnings (Loss) Per Share (Tabl
Earnings (Loss) Per Share (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of Basic and Diluted Net Income (Loss) Per Share | Basic and diluted net income (loss) per share was calculated as follows: Schedule of Basic and Diluted Net Income (Loss) Per Share 2021 2020 2021 2020 Three months ended September 30, Nine months ended September 30, 2021 2020 2021 2020 Basic net loss per share: Numerator: Net loss $ (6,094 ) $ (6,504 ) $ (2,994 ) $ (20,283 ) Denominator: Weighted-average number of common shares outstanding, basic and diluted 25,276,153 21,052,174 25,181,095 20,070,430 Net loss per share, basic and diluted $ (0.24 ) $ (0.31 ) $ (0.12 ) $ (1.01 ) |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Leases | |
Schedule of Lease-related Assets and Liabilities | The table below presents the lease-related assets and liabilities recorded on the balance sheet as of September 30, 2021 (in thousands). Schedule of Lease-related Assets and Liabilities Assets Classification Operating lease right-of-use assets Operating lease right-of-use assets, net $ 123 Total leased assets $ 123 Liabilities Operating lease liabilities, current Accrued liabilities $ 83 Operating lease liabilities, noncurrent Operating lease liabilities, net of current portion 36 Total operating lease liabilities $ 119 |
Schedule of Future Lease Commitments | The Company’s future lease commitments for its administrative offices in Deer Park, Illinois as of September 30, 2021 are as indicated below: Schedule of Future Lease Commitments Total 2021 2022 2023 Thereafter Undiscounted lease payments $ 124 22 88 14 — Less: Imputed interest (5 ) Total lease liabilities $ 119 |
Company Overview (Details Narra
Company Overview (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 9 Months Ended | |||||||
Oct. 31, 2020 | Aug. 31, 2020 | Apr. 30, 2020 | Mar. 31, 2020 | Nov. 30, 2019 | Nov. 30, 2018 | Jun. 30, 2017 | Sep. 30, 2021 | Sep. 30, 2020 | |
Subsidiary, Sale of Stock [Line Items] | |||||||||
Start-up capital | $ 20,055 | ||||||||
Proceeds from loan offering | $ 1,965 | $ 4,750 | $ 1,965 | ||||||
Proceeds from sale of shares of common stock | $ 7,756 | $ 7,756 | $ 7,756 | ||||||
IPO [Member] | |||||||||
Subsidiary, Sale of Stock [Line Items] | |||||||||
Net cash proceeds from initial public offering | $ 21,026 | $ 21,960 | |||||||
Common stock share price per share | $ 7 |
Liquidity Considerations (Detai
Liquidity Considerations (Details Narrative) - USD ($) $ in Thousands | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Net Cash Provided by (Used in) Operating Activities | $ 396 | $ (15,164) | |
Cash and cash equivalents | $ 22,709 | $ 21,295 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details Narrative) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | |||
May 31, 2021USD ($) | Sep. 30, 2021USD ($)$ / sharesshares | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($)Segment$ / sharesshares | Sep. 30, 2020USD ($)shares | Dec. 31, 2019USD ($) | Dec. 31, 2020USD ($) | |
Property, Plant and Equipment [Line Items] | |||||||
Number of reportable segments | Segment | 1 | ||||||
Accounts receivable reserves | $ 91 | $ 91 | $ 71 | ||||
Inventory Write-down | 432 | ||||||
Inventory Valuation Reserves | 1,414 | 1,414 | $ 623 | ||||
Proceeds from Sale of Machinery and Equipment | $ 700 | 700 | |||||
Excess book value of assets | $ 181 | ||||||
Net book value | 519 | 519 | |||||
Gain (Loss) on Disposition of Assets | 181 | ||||||
Payments to Acquire Intangible Assets | $ 750 | ||||||
Product and liscensing rights amortized, description | cost is being amortized over five years. | ||||||
Finite-Lived Intangible Assets, Accumulated Amortization | 287 | 287 | |||||
Amortization of Intangible Assets | 37 | 112 | |||||
Finite-Lived Intangible Asset, Expected Amortization, Year Three | 150 | 150 | |||||
Finite-Lived Intangible Asset, Expected Amortization, Year Four | 125 | 125 | |||||
Impairment of long-lived assets | 0 | ||||||
[custom:MilestoneFees] | 734 | 1,481 | |||||
Revenue from Contract with Customer, Excluding Assessed Tax | $ 775 | $ (161) | $ 15,739 | $ (42) | |||
Vested Warrant [Member] | |||||||
Property, Plant and Equipment [Line Items] | |||||||
Weighted average number of shares outstanding, basic | shares | 600,000 | 600,000 | |||||
Earnings Per Share, Basic | $ / shares | $ 0.01 | $ 0.01 | |||||
Stock Options Awards And Warrants [Member] | |||||||
Property, Plant and Equipment [Line Items] | |||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount | shares | 4,279,400 | 3,308,152 | |||||
Royalty [Member] | |||||||
Property, Plant and Equipment [Line Items] | |||||||
Revenue from Contract with Customer, Excluding Assessed Tax | $ 41 | $ 258 | |||||
Licensing Revenue [Member] | |||||||
Property, Plant and Equipment [Line Items] | |||||||
Revenue from Contract with Customer, Excluding Assessed Tax | $ 14,000 | ||||||
Computer Equipment [Member] | |||||||
Property, Plant and Equipment [Line Items] | |||||||
Estimated useful lives for property and equipment | 3 years | ||||||
Furniture and Fixtures [Member] | |||||||
Property, Plant and Equipment [Line Items] | |||||||
Estimated useful lives for property and equipment | 5 years | ||||||
Net book value | $ 31 | $ 31 | |||||
Leasehold Improvements [Member] | |||||||
Property, Plant and Equipment [Line Items] | |||||||
Estimated useful lives for property and equipment, description | estimated useful lives or the remaining lease term |
Schedule of Property and Equipm
Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Abstract] | ||
Computer hardware and software | $ 155 | $ 182 |
Furniture and fixtures | 105 | 143 |
Equipment | 132 | 994 |
Leasehold improvements | 71 | 184 |
Property and equipment, gross | 463 | 1,503 |
Less: accumulated depreciation | (329) | (692) |
Property and equipment, net | $ 134 | $ 811 |
Property and Equipment (Details
Property and Equipment (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation | $ 24 | $ 86 | $ 132 | $ 260 |
Net book value | $ 519 | $ 519 |
Schedule of Future Payments of
Schedule of Future Payments of Long Term Debt (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Debt Disclosure [Abstract] | ||
2021 | $ 212 | |
2022 | 2,202 | |
2023 | 1,756 | |
2024 | 5,300 | |
Total payments | 9,470 | |
Less: amount representing interest | (2,470) | |
Loan payable, gross | 7,000 | |
Less: current portion of long-term debt | (1,092) | |
Less: unamortized discount | (358) | |
Long-term debt, net of unamortized discount | $ 5,550 | $ 6,532 |
Long-Term Debt (Details Narrati
Long-Term Debt (Details Narrative) $ / shares in Units, $ in Thousands | May 20, 2021USD ($) | Aug. 11, 2020USD ($)$ / shares | Jul. 21, 2020USD ($) | May 04, 2020USD ($) | Nov. 13, 2019USD ($) | Jul. 31, 2021USD ($) | Nov. 30, 2019USD ($) | Sep. 30, 2021USD ($)$ / sharesshares | Sep. 30, 2020USD ($) | Aug. 31, 2020$ / sharesshares |
Debt Instrument [Line Items] | ||||||||||
Borrowing amount | $ 2,000 | $ 2,000 | ||||||||
Warrants issued to purchase common stock | shares | 1,554,826 | |||||||||
Warrants exercise price | $ / shares | $ 3.18 | |||||||||
Interest expenses | $ 766 | $ 617 | ||||||||
Debt discount amortization | 110 | $ 85 | ||||||||
Accrued interest | $ 107 | |||||||||
PPP Loan [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Borrowing amount | $ 361 | |||||||||
Interest expenses | 4 | |||||||||
Proceeds from loan | $ 365 | $ 361 | ||||||||
EIDL Loan [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Interest expenses | $ 6 | |||||||||
Proceeds from loan | $ 150 | |||||||||
Warrant [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Borrowing amount | 2,000 | |||||||||
Warrants issued to purchase common stock | shares | 51,239 | 18,141 | ||||||||
Warrants exercise price | $ / shares | $ 5.86 | $ 6.62 | ||||||||
Warrants, fair value | $ 94 | $ 226 | ||||||||
Warrants expiration term | 7 years | |||||||||
Warrant [Member] | Measurement Input, Exercise Price [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Warrants exercise price | $ / shares | $ 6.85 | $ 5.75 | ||||||||
Warrant [Member] | Measurement Input, Option Volatility [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Warrant measurement input | 95 | 95 | ||||||||
Warrant [Member] | Measurement Input, Expected Dividend Rate [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Warrant measurement input | 0 | 0 | ||||||||
Warrant [Member] | Measurement Input, Risk Free Interest Rate [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Warrant measurement input | 0.4 | 1.8 | ||||||||
Warrant [Member] | Measurement Input, Expected Term [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Warrants expiration term | 7 years | |||||||||
Food and Drug Administration's [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Borrowing amount | 3,000 | |||||||||
SWK Credit Agreement [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Borrowing amount | $ 5,000 | $ 5,000 | ||||||||
Debt Instrument, Interest Rate, Stated Percentage | 5.00% | |||||||||
Minimum cash balance | $ 3,000 | |||||||||
SWK Credit Agreement [Member] | Unused lines of Credit [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 2.00% | |||||||||
SWK Credit Agreement [Member] | London Interbank Offered Rate (LIBOR) Swap Rate [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 10.00% | |||||||||
SWK Credit Agreement [Member] | Stated LIBOR Floor Rate [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt Instrument, Interest Rate, Stated Percentage | 2.00% | |||||||||
SWK Credit Agreement [Member] | Food and Drug Administration's [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Borrowing amount | $ 5,000 | |||||||||
SWK Credit Agreement [Member] | Maximum [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Borrowing amount | $ 10,000 |
Common Stock (Details Narrative
Common Stock (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||
Jun. 30, 2021 | Apr. 30, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Common stock, shares authorized | 50,000,000 | 50,000,000 | 50,000,000 | ||||
Common stock, par value | $ 0.001 | $ 0.001 | $ 0.001 | ||||
Warrant [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Number of stock issued for exercise of stock warrants | 135,650 | ||||||
Intrinsic value of the warrants exercised | $ 806 | ||||||
Common Stock [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 6,000 | 32,500 | 144,233 | 102,378 | |||
Stock Issued During Period, Shares, New Issues | 2,600,000 | ||||||
Number of stock issued for exercise of stock warrants | 94,808 | ||||||
Employee stock purchase plan, shares | 29,326 | 14,005 | |||||
Employees [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Employee stock purchase plan, shares | 29,326 | ||||||
Restricted Stock Units (RSUs) [Member] | Board of Directors [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Stock Issued During Period, Shares, New Issues | 25,000 | ||||||
2018 Equity Incentive Plan [Member] | |||||||
Accumulated Other Comprehensive Income (Loss) [Line Items] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 144,233 |
Summary of Warrants Outstanding
Summary of Warrants Outstanding (Details) | Sep. 30, 2021$ / sharesshares |
No. of Shares, Total | shares | 1,554,826 |
Exercise Price | $ / shares | $ 3.18 |
Business Advisory Warrants [Member] | |
No. of Shares, Total | shares | 600,000 |
Exercise Price | $ / shares | $ 0.01 |
Placement Agent Warrants - 2017 Preferred Stock Offering [Member] | |
No. of Shares, Total | shares | 471,446 |
Exercise Price | $ / shares | $ 3 |
Placement Agent Warrants - IPO [Member] | |
No. of Shares, Total | shares | 414,000 |
Exercise Price | $ / shares | $ 7.50 |
SWK Warrants - Debt Tranche #1 [Member] | |
No. of Shares, Total | shares | 51,239 |
Exercise Price | $ / shares | $ 5.86 |
SWK Warrants - Debt Tranche #2 [Member] | |
No. of Shares, Total | shares | 18,141 |
Exercise Price | $ / shares | $ 6.62 |
Summary of Stock Option Activit
Summary of Stock Option Activity (Details) - Equity Option [Member] - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Offsetting Assets [Line Items] | ||
Shares, Options Outstanding, Beginning Balance | 2,824,500 | |
Weighted Average Exercise Price, Options Outstanding, Beginning Balance | $ 4.05 | |
Weighted Average Remaining Contractual Term, Options Outstanding, Beginning Balance | 8 years 1 month 6 days | 8 years 3 months 18 days |
Aggregate Intrinsic Value, Options Outstanding, Beginning Balance | $ 11,525 | |
Shares, Issued | 902,098 | |
Weighted Average Exercise Price, Issued | $ 8.61 | |
Shares, Exercised | (144,233) | |
Weighted Average Exercise Price, Exercised | $ 2.35 | |
Shares, Forfeited/Cancelled | (12,500) | |
Weighted Average Exercise Price, Forfeited/Cancelled | $ 7.31 | |
Shares, Options Outstanding, Ending Balance | 3,569,865 | 2,824,500 |
Weighted Average Exercise Price, Options Outstanding, Ending Balance | $ 5.26 | $ 4.05 |
Aggregate Intrinsic Value, Options Outstanding, Ending Balance | $ 4,167 | $ 11,525 |
Shares, Options Exercisable, Ending Balance | 1,734,652 | |
Weighted Average Exercise Price, Options Exercisable, Ending Balance | $ 4 | |
Weighted Average Remaining Contractual Term, Options Exercisable, Ending Balance | 7 years 4 months 24 days | |
Aggregate Intrinsic Value, Options Exercisable, Ending Balance | $ 2,961 | |
Shares, Options Vested and Expected to Vest, Ending Balance | 3,519,865 | |
Weighted Average Exercise Price, Options Vested and Expected to Vest, Ending Balance | $ 5.31 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested and Expected to Vest, Outstanding, Weighted Average Remaining Contractual Term | 8 years 1 month 6 days | |
Aggregate Intrinsic Value, Options Vested and Expected to Vest, Ending Balance | $ 3,984 |
Schedule of Assumptions Used to
Schedule of Assumptions Used to Calculate Fair Value of Options Granted (Details) | 9 Months Ended |
Sep. 30, 2021$ / shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Expected dividends | 0.00% |
Expected volatility | 80.00% |
Share Price | $ 5.88 |
Minimum [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Risk-free interest rate | 0.90% |
Expected term | 5 years 3 months 18 days |
Maximum [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Risk-free interest rate | 1.10% |
Expected term | 6 years 3 months 18 days |
Share-Based Payment Awards (Det
Share-Based Payment Awards (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | Sep. 30, 2018 | Apr. 30, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2017 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2018 | May 31, 2017 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Stock-based compensation expense | $ 1,009 | $ 724 | $ 2,518 | $ 1,803 | |||||
Expected dividend yield | 0.00% | ||||||||
General and Administrative Expense [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Stock-based compensation expense | 838 | 647 | $ 2,110 | 1,623 | |||||
Research and Development Expense [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Stock-based compensation expense | $ 171 | $ 77 | $ 408 | $ 180 | |||||
Common Stock [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 6,000 | 32,500 | 144,233 | 102,378 | |||||
Employee stock purchase plan, shares | 29,326 | 14,005 | |||||||
Four Stock Options [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 144,233 | 102,378 | |||||||
Share-based Compensation Arrangements by Share-based Payment Award, Options, Exercises in Period, Weighted Average Exercise Price | $ 2.35 | $ 1.37 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period, Intrinsic Value | $ 682 | $ 436 | |||||||
Product Consultant [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Number of stock options issued to purchase common stock | 50,000 | ||||||||
Product Consultant [Member] | Common Stock [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Stock options expiration period | 5 years | ||||||||
Restricted Stock [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Shares issued as compensation | 100,000 | ||||||||
Restricted Stock [Member] | Outside Directors One [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Shares issued as compensation | 25,000 | ||||||||
Restricted Stock [Member] | Outside Directors Two [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Shares issued as compensation | 25,000 | ||||||||
Restricted Stock [Member] | Outside Directors Three [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Shares issued as compensation | 25,000 | ||||||||
Restricted Stock [Member] | Outside Directors Four [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Shares issued as compensation | 25,000 | ||||||||
Shares issued as vested compensation | 25,000 | ||||||||
Restricted Stock [Member] | Four Outside Directors [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Restricted shares to outside directors vesting percentage | 100.00% | ||||||||
Equity Option [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Stock options expiration period | 10 years | ||||||||
Non-Vested Stock Option Awards and Restricted Awards [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Share-based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount | $ 7,270 | $ 7,270 | |||||||
2017 Equity Incentive Plan [Member] | Maximum [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 | 5,000,000 | ||||||||
2018 Equity Incentive Plan [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Share-based compensation arrangement, shares available for future issuance | 481,160 | 481,160 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Exercises in Period | 144,233 | ||||||||
2018 Equity Incentive Plan [Member] | January 1, 2019 and Through January 1, 2028 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Percentage for total number of shares outstanding | 4.00% | ||||||||
2018 Employee Stock Purchase Plan [Member] | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||
Share-based compensation arrangement, shares available for future issuance | 500,009 | 500,009 | 150,000 | ||||||
Stock-based compensation expense | $ 83 | $ 38 | |||||||
Share based compensation for initial shares reserve, description | The Company’s ESPP provides for an initial reserve of 150,000 shares and this reserve is automatically increased on January 1 of each year by the lesser of 1% of the outstanding common shares at December 31 of the preceding year or 150,000 shares, subject to reduction at the discretion of the Company’s board of directors. | ||||||||
Description for deductions to purchase stock at price per share | The terms of the ESPP permit employees of the Company to use payroll deductions to purchase stock at a price per share that is at least the lesser of (1) 85% of the fair market value of a share of common stock on the first date of an offering or (2) 85% of the fair market value of a share of common stock on the date of purchase. After the initial offering period ended, subsequent twelve-month offering periods automatically commence over the term of the ESPP on the day that immediately follows the conclusion of the preceding offering, each consisting of two purchase periods approximately six months in duration | ||||||||
Employee stock purchase plan, shares | 29,326 | 14,005 | |||||||
Weighted average grant date fair value issued | $ 2.83 | $ 2.43 | |||||||
Employees contribution amount | $ 192 | $ 100 | |||||||
Accrued liabilities for remaining employee contributions | $ 77 | $ 19 | $ 77 | $ 19 |
Schedule of Basic and Diluted N
Schedule of Basic and Diluted Net Income (Loss) Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Earnings Per Share [Abstract] | ||||
Net loss | $ (6,094) | $ (6,504) | $ (2,994) | $ (20,283) |
Weighted-average number of common shares outstanding, basic and diluted | 25,276,153 | 21,052,174 | 25,181,095 | 20,070,430 |
Net loss per share, basic and diluted | $ (0.24) | $ (0.31) | $ (0.12) | $ (1.01) |
Related Party Transactions (Det
Related Party Transactions (Details Narrative) - USD ($) | Feb. 18, 2019 | Jan. 23, 2019 | Nov. 17, 2017 | Aug. 11, 2017 | May 31, 2021 | Apr. 30, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2018 | Apr. 01, 2021 | Dec. 31, 2020 |
Related Party Transaction [Line Items] | |||||||||||||
Common Stock Shares Issued | 24,606,175 | 24,606,175 | 1,518,000 | 24,312,808 | |||||||||
Common Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||||
Shares Owned | $ 1,982,000 | ||||||||||||
Proceeds from Sale of Machinery and Equipment | $ 700,000 | 700,000 | |||||||||||
Payment of research and development expense | $ 2,678,000 | $ 2,826,000 | $ 5,554,000 | $ 10,703,000 | |||||||||
Credit agreement term | 10 years | 10 years | |||||||||||
Imprimis Pharmaceuticals [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Proceeds from Sale of Machinery and Equipment | 700,000 | ||||||||||||
Gain on sale of lab equipment | $ 181,000 | ||||||||||||
Eyemax [Member] | Amended and Restated Agreement [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Sale of product expense | $ 2,000,000 | ||||||||||||
Eyemax [Member] | Amended and Restated Agreement [Member] | One Milestone [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Related party transaction | 250,000 | ||||||||||||
Eyemax [Member] | Amended and Restated Agreement [Member] | Two Milestone [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Related party transaction | $ 500,000 | ||||||||||||
Harrow Health Inc. [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Common Stock Shares Issued | 3,500,000 | 3,500,000 | |||||||||||
Common Stock, Par or Stated Value Per Share | $ 0.001 | $ 0.001 | |||||||||||
Harrow Health Inc. [Member] | Common Stock [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Restricted stock award forfeited | 20,000 | ||||||||||||
Harrow Health Inc. [Member] | Restricted Stock [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Number of restricted common stock issued for services | 1,500,000 | ||||||||||||
Number of stock options issued to purchase common stock | 130,000 | ||||||||||||
Harrow Health Inc. [Member] | Restricted Stock [Member] | Chief Executive Officer [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Number of restricted common stock issued for services | 25,000 | ||||||||||||
Eyemax [Member] | |||||||||||||
Related Party Transaction [Line Items] | |||||||||||||
Related party transaction | $ 250,000 | ||||||||||||
Payment of research and development expense | 250,000 | ||||||||||||
Sale of product expense | $ 500,000 | ||||||||||||
Percentage of royalty fee | 10.00% | ||||||||||||
Related party transaction, description | The Eyemax Agreement was for an initial term of 10 years from the date of the Eyemax Agreement, subject to successive two-year renewals unless the Company elected to terminate the Eyemax Agreement. | ||||||||||||
Credit agreement term | 10 years |
Schedule of Lease-related Asset
Schedule of Lease-related Assets and Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Total leased assets | $ 123 | $ 192 |
Operating lease liabilities, current | 83 | |
Operating Lease Right-of-use Assets [Member] | ||
Total leased assets | 123 | |
Accrued Liabilities [Member] | ||
Operating lease liabilities, current | 36 | |
Operating Lease Liabilities [Member] | ||
Operating lease liabilities, current | $ 119 |
Schedule of Future Lease Commit
Schedule of Future Lease Commitments (Details) - Operating Lease Liability [Member] $ in Thousands | Sep. 30, 2021USD ($) |
Undiscounted lease payments | $ 124 |
2021 | 22 |
2022 | 88 |
2023 | 14 |
Thereafter | |
Less: Imputed interest | (5) |
Total lease liabilities | $ 119 |
Leases (Details Narrative)
Leases (Details Narrative) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Cash paid for operating lease liabilities | $ 63 | |||
ROU asset amortization | $ 20 | $ 33 | $ 69 | $ 97 |
Weighted-average remaining lease term | 1 year 6 months | 1 year 6 months | ||
Weighted-average incremental borrowing rate | 5.40% | 5.40% | ||
Research and Development Expense [Member] | ||||
Operating lease cost | $ 0 | 13 | $ 9 | 41 |
General and Administrative Expense [Member] | ||||
Operating lease cost | $ 21 | $ 21 | $ 64 | $ 62 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | Aug. 16, 2021 | Jun. 15, 2021 | Mar. 26, 2020 | Jun. 12, 2019 | Feb. 08, 2019 | Jan. 23, 2019 | Nov. 17, 2017 | Oct. 31, 2021 | Oct. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 |
Product Liability Contingency [Line Items] | |||||||||||||
Percentage of net profits payments to third party from sale of product | 50.00% | ||||||||||||
Litigation related product profit, percentage | 62.50% | ||||||||||||
Credit agreement term | 10 years | 10 years | |||||||||||
Payments for development | $ 2,678 | $ 2,826 | $ 5,554 | $ 10,703 | |||||||||
Stock Issued During Period, Value, New Issues | 7,756 | ||||||||||||
Tulex Pharmaceuticals [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Payment of filing fee | $ 1,438 | ||||||||||||
Diurnal Limited [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
[custom:PaymentForObtainingProductOrphanDrug] | 2,500 | ||||||||||||
Exclusive License and Supply Agreement (ET-202 ) [Member] | Subsequent Event [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Payment of milestone fee | $ 600 | ||||||||||||
Exclusive License and Supply Agreement (ET-202 ) [Member] | Licensor [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Credit agreement term | 10 years | ||||||||||||
Exclusive License and Supply Agreement (ET-202 ) [Member] | Upon FDA Approval [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Payment of licensing | $ 750 | $ 750 | |||||||||||
Exclusive License and Supply Agreement (ET-202 ) [Member] | Sintetica [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Payment of licensing | $ 2,000 | ||||||||||||
Percentage of net sales as marketing fees | 5.00% | ||||||||||||
Proceeds from licensing | $ 500 | ||||||||||||
Percentage for additional profit | 50.00% | ||||||||||||
Exclusive License and Supply Agreement (ET-203) [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Percentage for additional profit | 50.00% | ||||||||||||
Exclusive License and Supply Agreement (ET-203) [Member] | Sintetica [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Payment of licensing | $ 1,000 | ||||||||||||
Percentage of net sales as marketing fees | 5.00% | ||||||||||||
Proceeds from licensing | $ 500 | ||||||||||||
Percentage for additional profit | 50.00% | ||||||||||||
License and Supply Agreement (ET-203) [Member] | Licensor [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Credit agreement term | 10 years | ||||||||||||
Licensing and Supply Agreement [Member] | Licensor [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Percentage of net profits payments to third party from sale of product | 35.00% | ||||||||||||
Payments for development | $ 350 | ||||||||||||
Licensing and Supply Agreement [Member] | Upon FDA Approval [Member] | Licensor [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Payments for development | 325 | ||||||||||||
Licensing and Supply Agreement [Member] | Upon Successful Bioequivalence Study [Member] | Licensor [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Payments for development | 350 | ||||||||||||
Licensing and Supply Agreement [Member] | Upon FDA Acceptance [Member] | Licensor [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Payments for development | 325 | ||||||||||||
Licensing and Supply Agreement [Member] | Upon Issuance of Patent Covering [Member] | Licensor [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Payments for development | 650 | ||||||||||||
Licensing and Supply Agreement [Member] | Product Sales [Member] | Licensor [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Payments for development | 500 | ||||||||||||
Licensing and Supply Agreement [Member] | Calendar Year [Member] | Licensor [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Payments for development | $ 10,000 | ||||||||||||
Exclusive License and Supply Agreement (ET-105 ) [Member] | Aucta Pharmaceuticals, Inc [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Payment of licensing | $ 2,000 | ||||||||||||
Exclusive License and Supply Agreement (ET-105 ) [Member] | Aucta Pharmaceuticals, Inc [Member] | Maximum [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Milestone payment amount | 18,000 | ||||||||||||
Exclusive License and Supply Agreement (ET-105 ) [Member] | Upon FDA Approval [Member] | Aucta Pharmaceuticals, Inc [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Payment of licensing | 2,450 | ||||||||||||
Exclusive License and Supply Agreement (ET-105 ) [Member] | Upon Issuance of Orange-book Listed Patent [Member] | Aucta Pharmaceuticals, Inc [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Payment of licensing | 1,000 | ||||||||||||
Exclusive License and Supply Agreement (ET-105 ) [Member] | Upon FDA Acceptance of Product Filing [Member] | Aucta Pharmaceuticals, Inc [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Payment of licensing | 1,500 | ||||||||||||
Exclusive License and Supply Agreement (ET-105 ) [Member] | Upon FDA Approval and Commercial Sales [Member] | Aucta Pharmaceuticals, Inc [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Payment of licensing | $ 1,950 | ||||||||||||
Exclusive License and Supply Agreement (ET-105 ) [Member] | Sales Exceed $10 Million [Member] | Aucta Pharmaceuticals, Inc [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Milestone payment description | 1,000 when net sales exceed $10 million in a calendar year | ||||||||||||
Exclusive License and Supply Agreement (ET-105 ) [Member] | Sales Exceed $20 Million [Member] | Aucta Pharmaceuticals, Inc [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Milestone payment description | 2,000 when net sales exceed $20 million in a calendar year | ||||||||||||
Exclusive License and Supply Agreement (ET-105 ) [Member] | Sales Exceed $50 Million [Member] | Aucta Pharmaceuticals, Inc [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Milestone payment description | 5,000 when net sales exceed $50 million in a calendar year | ||||||||||||
Exclusive License and Supply Agreement (ET-105 ) [Member] | Sales Exceed $100 Million [Member] | Aucta Pharmaceuticals, Inc [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Milestone payment description | 10,000 when net sales exceed $100 million in a calendar year | ||||||||||||
Exclusive License and Supply Agreement [Member] | Diurnal Limited [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Cash paid for licensing milestone fee | $ 3,500 | ||||||||||||
Stock Issued During Period, Shares, New Issues | 379,474 | ||||||||||||
Stock Issued During Period, Value, New Issues | $ 1,264 | ||||||||||||
Shares Issued, Price Per Share | $ 3.33 | ||||||||||||
[custom:AggregateValueOfLicensingMilestoneIncludedInResearchAndDevelopmentExpense] | $ 4,764 | ||||||||||||
Distribution and Promotion License Agreement [Member] | Crossject S.A. [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Payments for development | $ 500 | $ 500 | |||||||||||
Distribution and Promotion License Agreement [Member] | Crossject S.A. [Member] | Maximum [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Cash paid for licensing milestone fee | 6,000 | ||||||||||||
Distribution and Promotion License Agreement [Member] | Upon FDA Acceptance of Product Filing [Member] | Crossject S.A. [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Payments for development | 1,500 | ||||||||||||
Distribution and Promotion License Agreement [Member] | Upon FDA Approval and Commercial Sales [Member] | Crossject S.A. [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Payments for development | $ 2,000 | ||||||||||||
Distribution and Promotion License Agreement [Member] | Sales Exceed $10 Million [Member] | Crossject S.A. [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Milestone payment description | 1,000 when net sales exceed $10 million in any four consecutive quarters | ||||||||||||
Distribution and Promotion License Agreement [Member] | Sales Exceed $20 Million [Member] | Crossject S.A. [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Milestone payment description | 2,000 when net sales exceed $20 million in any four consecutive quarters |
Subsequent Events (Details Narr
Subsequent Events (Details Narrative) - USD ($) $ in Thousands | Oct. 27, 2021 | Nov. 17, 2017 |
Subsequent Event [Line Items] | ||
Percentage of net profits payments | 50.00% | |
License Agreement [Member] | Development Partners [Member] | Subsequent Event [Member] | ||
Subsequent Event [Line Items] | ||
Payments for licensing rights | $ 3,250 | |
Percentage of net profits payments | 50.00% |