Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Mar. 07, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Fiscal Period Focus | FY | ||
Document Fiscal Year Focus | 2022 | ||
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 | ||
Trading Symbol | ETON | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | 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 Public Float | $ 51.5 | ||
Entity Common Stock, Shares Outstanding | 25,458,057 | ||
Documents Incorporated by Reference [Text Block] | Portions of the registrant’s definitive proxy statement for its 2023 Annual Meeting of Stockholders, which the registrant intends to file pursuant to Regulation 14A with the Securities and Exchange Commission not later than 120 days after the registrant’s fiscal year ended December 31, 2022, are incorporated by reference into Part III of this Annual Report on Form 10-K | ||
ICFR Auditor Attestation Flag | false | ||
Auditor Firm ID | 170 | ||
Auditor Name | KMJ Corbin & Company LLP | ||
Auditor Location | Irvine, California |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 16,305 | $ 14,406 |
Accounts receivable, net | 1,852 | 5,471 |
Inventories | 557 | 550 |
Prepaid expenses and other current assets | 1,290 | 3,177 |
Total current assets | 20,004 | 23,604 |
Property and equipment, net | 72 | 115 |
Intangible assets, net | 4,754 | 3,621 |
Operating lease right-of-use assets, net | 188 | 104 |
Other long-term assets, net | 12 | 21 |
Total assets | 25,030 | 27,465 |
Current liabilities: | ||
Accounts payable | 1,766 | 1,774 |
Current portion of long-term debt | 1,033 | 1,418 |
Accrued liabilities | 3,662 | 1,366 |
Total current liabilities | 6,461 | 4,558 |
Long-term debt, net of discount and including accrued fees | 5,384 | 5,262 |
Operating lease liabilities, net of current portion | 107 | 15 |
Total liabilities | 11,952 | 9,835 |
Commitments and contingencies (Note 14) | ||
Stockholders’ equity | ||
Common stock, $0.001 par value; 50,000,000 shares authorized; 25,353,119 and 24,626,004 shares issued and outstanding at December 31, 2022 and 2021, respectively | 25 | 25 |
Additional paid-in capital | 116,187 | 111,718 |
Accumulated deficit | (103,134) | (94,113) |
Total stockholders’ equity | 13,078 | 17,630 |
Total liabilities and stockholders’ equity | $ 25,030 | $ 27,465 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
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 | 25,353,119 | 24,626,004 |
Common stock, shares outstanding | 25,353,119 | 24,626,004 |
Statements of Operations
Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Revenues: | |||
Total net revenues | $ 21,251 | $ 21,832 | $ 39 |
Cost of Sales: | |||
Total cost of sales | 6,933 | 2,827 | 436 |
Gross profit (loss) | 14,318 | 19,005 | (397) |
Operating expenses: | |||
Research and development | 3,996 | 6,235 | 14,104 |
General and administrative | 18,582 | 14,265 | 12,610 |
Total operating expenses | 22,578 | 20,500 | 26,714 |
Loss from operations | (8,260) | (1,495) | (27,111) |
Other income (expense): | |||
Interest and other income (expense), net | (761) | (1,006) | (859) |
Gain on PPP loan forgiveness | 365 | ||
Gain on equipment sale | 181 | ||
Loss before income tax expense | (9,021) | (1,955) | (27,970) |
Income tax expense | |||
Net loss | $ (9,021) | $ (1,955) | $ (27,970) |
Net loss per share, basic and diluted | $ (0.36) | $ (0.08) | $ (1.33) |
Weighted average number of common shares outstanding, basic and diluted | 25,145,657 | 25,207,299 | 21,010,058 |
Licensing Revenue [Member] | |||
Revenues: | |||
Total net revenues | $ 10,000 | $ 19,000 | |
Cost of Sales: | |||
Total cost of sales | 1,640 | 1,500 | |
Product Sales And Royalties [Member] | |||
Revenues: | |||
Total net revenues | 11,251 | 2,832 | 39 |
Cost of Sales: | |||
Total cost of sales | $ 5,293 | $ 1,327 | $ 436 |
Statements of Stockholders' Equ
Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock [Member] | Additional Paid-in Capital [Member] | Retained Earnings [Member] | Total |
Beginning balance, value at Dec. 31, 2019 | $ 18 | $ 74,720 | $ (64,188) | $ 10,550 |
Beginning balance, shares at Dec. 31, 2019 | 17,877,486 | |||
Stock-based compensation | 2,576 | 2,576 | ||
Stock-based compensation, shares | 15,190 | |||
Stock option exercises | 255 | 255 | ||
Stock option exercises, shares | 194,878 | |||
Employee stock purchase plan | 112 | 112 | ||
Employee stock purchase plan, shares | 25,780 | |||
Proceeds from sales of common stock, net of offering costs | $ 6 | 28,776 | 28,782 | |
Proceeds from sales of common stock, net of offering costs, shares | 5,820,000 | |||
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 | |||
Relative fair value of warrants to purchase common stock issued in connection with debt | 94 | 94 | ||
Net loss | (27,970) | (27,970) | ||
Ending balance, value at Dec. 31, 2020 | $ 24 | 107,797 | (92,158) | 15,663 |
Ending balance, shares at Dec. 31, 2020 | 24,312,808 | |||
Stock-based compensation | 3,381 | 3,381 | ||
Stock-based compensation, shares | ||||
Stock option exercises | $ 1 | 338 | 339 | |
Stock option exercises, shares | 144,233 | |||
Employee stock purchase plan | 202 | 202 | ||
Employee stock purchase plan, shares | 49,155 | |||
Proceeds from sales of common stock, net of offering costs, shares | 94,808 | |||
Net loss | (1,955) | (1,955) | ||
Common stock issued related to restricted stock units | ||||
Common stock issued related to restricted stock units, shares | 25,000 | |||
Stock warrant exercises | ||||
Stock warrant exercises, shares | 94,808 | |||
Ending balance, value at Dec. 31, 2021 | $ 25 | 111,718 | (94,113) | 17,630 |
Ending balance, shares at Dec. 31, 2021 | 24,626,004 | |||
Stock-based compensation | 4,218 | 4,218 | ||
Stock-based compensation, shares | ||||
Stock option exercises | 35 | 35 | ||
Stock option exercises, shares | 25,000 | |||
Employee stock purchase plan | 171 | 171 | ||
Employee stock purchase plan, shares | 69,884 | |||
Net loss | (9,021) | (9,021) | ||
Stock warrant exercises | 45 | 45 | ||
Stock warrant exercises, shares | 632,231 | |||
Ending balance, value at Dec. 31, 2022 | $ 25 | $ 116,187 | $ (103,134) | $ 13,078 |
Ending balance, shares at Dec. 31, 2022 | 25,353,119 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities | |||
Net loss | $ (9,021) | $ (1,955) | $ (27,970) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | |||
Stock-based compensation | 4,218 | 3,381 | 2,576 |
Common stock issued for product candidate licensing rights | 1,264 | ||
Depreciation and amortization | 1,774 | 462 | 651 |
Debt discount amortization | 127 | 148 | 121 |
Gain on forgiveness of PPP loan | (365) | ||
Gain on sale of equipment | (181) | ||
Changes in operating assets and liabilities: | |||
Accounts receivable | 3,619 | (5,423) | 425 |
Inventories | (7) | 692 | (862) |
Prepaid expenses and other assets | 1,902 | (1,026) | (20) |
Accounts payable | (8) | (570) | 1,769 |
Accrued liabilities | 2,217 | 116 | (300) |
Net cash provided by (used in) operating activities | 4,821 | (4,721) | (22,346) |
Cash used in investing activities | |||
Proceeds from sale of equipment | 700 | ||
Purchases of property and equipment | (38) | (9) | (50) |
Purchase of product licensing rights | (2,750) | (3,250) | |
Net cash used in investing activities | (2,788) | (2,559) | (50) |
Cash flows from financing activities | |||
Proceeds from issuance of long-term debt, net of issuance costs | 1,965 | ||
Proceeds from sales of common stock, net of offering costs | 28,782 | ||
Proceeds from PPP and EIDL loans | 511 | ||
Debt paydown | (385) | (150) | |
Proceeds from employee stock purchase plan and stock option and stock warrant exercises | 251 | 541 | 367 |
Net cash (used in) provided by financing activities | (134) | 391 | 31,625 |
Change in cash and cash equivalents | 1,899 | (6,889) | 9,229 |
Cash and cash equivalents at beginning of year | 14,406 | 21,295 | 12,066 |
Cash and cash equivalents at end of year | 16,305 | 14,406 | 21,295 |
Supplemental disclosures of cash flow information | |||
Cash paid for interest | 730 | 815 | 797 |
Cash paid for income taxes | |||
Supplemental disclosures of non-cash investing and financing activities: | |||
Relative fair value of common stock warrants issued in connection with debt | 94 | ||
Right-of-use assets obtained in exchange for lease liabilities | $ 188 | $ 195 |
Company Overview
Company Overview | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Company Overview | Note 1 — Company Overview Eton is an innovative pharmaceutical company focused on developing, acquiring, and commercializing innovative products to address unmet needs in patients suffering from rare diseases. The Company currently has three FDA-approved rare disease products, ALKINDI SPRINKLE® for the treatment of adrenocortical insufficiency, Carglumic Acid for the treatment of hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency, and Betaine Anhydrous for the treatment of homocystinuria and has three additional product candidates in late-stage development. The Company is developing dehydrated alcohol injection, which has received Orphan Drug Designation for the treatment of methanol poisoning, ZENEO® hydrocortisone autoinjector for the treatment of adrenal crisis, and ET-400. In addition, the Company is entitled to royalties or milestone payments from six FDA-approved products that the Company developed and out-licensed. The products are Alaway® Preservative Free, EPRONTIA®, Cysteine Hydrochloride, ZONISADE™, Lamotrigine, and Biorphen®. |
Liquidity Considerations
Liquidity Considerations | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Liquidity Considerations | Note 2 — Liquidity Considerations As of December 31, 2022, the Company had an accumulated deficit of $ 103,134 9,021 To date, the Company has generated revenues from multiple products and expects further growth in 2023 and beyond in accordance with additional market penetration from these products plus revenues from additional products where it anticipates FDA approval. The Company currently believes its existing cash and cash equivalents of $ 16,305 |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
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 GAAP. Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) Note 3 — Summary of Significant Accounting Policies (continued) 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 at 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, chargebacks and sales returns, valuation of inventories, useful lives of assets and the impairment of property and equipment, deferred tax assets, the accrual of research and development expenses and the valuation of common stock, stock options and warrants, and restricted stock units (“RSUs”). 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 money market funds. From time to time, amounts deposited with its bank exceed federally insured limits. 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 $ 262 96 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. Inventories at December 31, 2022 and 2021 consist solely of purchased finished goods. At December 31, 2022, inventories are shown net of a reserve for damaged Biorphen inventory yet to be destroyed and net of ALKINDI SPRINKLE® inventory at risk of expiry prior to being sold. At December 31, 2021, inventories are shown net of a reserve for Biorphen inventory due to the risk of expiry prior to being sold. There was an inventory reserve of $ 62 1,414 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 Maintenance and repairs are charged to expense as incurred, while renewals and improvements are capitalized. Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) Note 3 — Summary of Significant Accounting Policies (continued) 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. In November 2021, the Company purchased the rights for its Carglumic Acid product for $ 3,250 ten years 750 five years 275 75 750 five years 738 2,000 five years 1,996 1,617 204 150 204 150 Schedule of Intangible Assets Amortization Expenses Year Amortization Expense 2023 $ 725 2024 725 2025 725 2026 725 2027 608 Thereafter 1,246 Total estimated amortization expense $ 4,754 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 impairment was recognized during the years ended December 31, 2022, 2021 and 2020. 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. Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) Note 3 — Summary of Significant Accounting Policies (continued) Leases The Company accounts for leases in accordance with ASC Topic 842 — Leases. The Company reviews all relevant facts and circumstances of a contract to determine if it is a lease whereby the terms of the agreement convey the right to control the direct use and receive substantially all the economic benefits of an identified asset for a period of time in exchange for consideration. The associated right-of-use assets and lease liabilities are recognized at lease commencement. The Company measures lease liabilities based on the present value of the lease payments over the lease term discounted using the rate it would pay on a loan with the equivalent payments and term for the lease. The Company does not include the impact for lease term options that would extend or terminate the lease unless it is reasonably certain that it will exercise any such options. The Company accounts for the lease components separately from non-lease components for its operating leases. The Company measures right-of-use assets based on the corresponding lease liabilities adjusted for (i) any prepayments made to the lessor at or before the commencement date, (ii) initial direct costs it incurs, and (iii) any incentives under the lease. In addition, the Company evaluates the recoverability of its right-of-use assets for possible impairment in accordance with its long-lived assets policy. Operating leases are reflected on the balance sheets as operating lease right-of-use assets, current accrued liabilities and long-term operating lease liabilities. The Company does no The Company commences recognizing operating lease expense when the lessor makes the underlying asset available for use by the Company and the operating lease expense is recognized on a straight-line basis over the term of the lease. Variable lease payments are expensed as incurred. The Company does not recognize right-of-use assets or lease liabilities for leases with a term of twelve months or less; such lease costs are recorded in the statements of operations on a straight-line basis over the lease term. Patent Costs All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the successful award of a patent and the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses. Concentrations of Credit Risk, Sources of Supply and Significant Customers The Company is subject to credit risk for its cash and cash equivalents which are invested in money market funds and U.S. treasury bills from time to time. The Company maintains its cash and cash equivalent balances with one major commercial bank and the deposits held with the financial institution exceed the amount of insurance provided on such deposits and is exposed to credit risk in the event of a default by the financial institutions holding its cash and cash equivalents to the extent recorded on the balance sheets. The Company believes the associated credit risk to be minimal. The Company is dependent on third-party suppliers for its products and product candidates. In particular, the Company relies, and expects to continue to rely, on a small number of suppliers to manufacture key chemicals, approved products and process its product candidates as part of its development programs. These programs could be adversely affected by a significant interruption in the manufacturing process. Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) Note 3 — Summary of Significant Accounting Policies (continued) The Company is also subject to credit risk from its accounts receivable related to product sales as it extends credit based on an evaluation of the customer’s financial condition, and collateral is not required. Management monitors its exposure to accounts receivable by periodically evaluating the collectability of the account receivable based on a variety of factors including the length of time the receivables are past due, the financial health of the customer and historical experience. Based upon the review of these factors, the Company recorded no allowance for doubtful accounts at December 31, 2022 or 2021. The accounts receivable balance at December 31, 2022 and 2021 and product sales revenue recognized during the year ended December 31, 2022 and 2021 consist of sales to and amounts due from AmerisourceBergen Corporation, Cardinal Health Services and McKesson Corporation for sales of the Company’s Biorphen product. The December 31, 2022 accounts receivable balance and sales in 2022 also include amounts due from AnovoRx for sales of the Company’s ALKINDI SPRINKLE® product and its Carglumic Acid product. AnovoRx sales made up 45.5 79.8 9.0 6.4 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. 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 Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) Note 3 — Summary of Significant Accounting Policies (continued) Royalties – Significant Financing Component – The Company sells its ALKINDI SPRINKLE® and Carglumic Acid product to one pharmacy distributor customer which provides order fulfilment and inventory storage/distribution services. The Company may sell products 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 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. For its ALKINDI SPRINKLE® and Carglumic Acid products, 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. Selling prices initially billed to wholesalers are subject to discounts for prompt payment and subsequent chargebacks when the wholesalers sell products at negotiated discounted prices to members of certain group purchasing organizations (“GPOs”) and government programs. Because of the shelf life of the product 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. 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 and the impact of other discounts and fees it pays, although ALKINDI SPRINKLE® and Carglumic Acid sales 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 stores its ALKINDI SPRINKLE® and Carglumic Acid inventory at its pharmacy distributor customer location, and sales are recorded when stock is pulled and shipped to fulfill specific patient orders. The Company recognizes revenue and cost of sales from products sold to wholesalers upon 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. 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 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 anticipates it will receive revenues from product licensing agreements where it has contracted for milestone payments and royalties from products it has developed or acquired. Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) Note 3 — Summary of Significant Accounting Policies (continued) Cost of Product Sales Cost of product 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, the amortization of certain intangible assets, 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. Income (Loss) Per Share Basic net income (loss) per common share is computed by dividing net income (loss) attributable to common stockholders for the period by the weighted average number of common shares outstanding during the period. Diluted net income (loss) per share is computed by dividing the net income (loss) attributable to common stockholders for the period by the weighted average number of common and common equivalent shares, such as Series A Preferred, unvested restricted stock, stock options and warrants that are outstanding during the period. Common stock equivalents are excluded from the computation when their inclusion would be anti-dilutive. No such adjustments were made for 2022, 2021 or 2020 as the Company reported a net loss for the years ended December 31, 2022, 2021 and 2020 and including the effects of common stock equivalents in the diluted earnings per share calculation would have been anti-dilutive (see Note 9). 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, 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. The Company uses the closing common stock price on the date of grant for the fair value of the common stock. Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) Note 3 — Summary of Significant Accounting Policies (continued) Income Taxes As part of the process of preparing the Company’s financial statements, the Company must estimate the actual current tax liabilities and assess temporary differences resulting from differing treatment of items for tax and accounting purposes. These differences result in deferred tax assets and liabilities, which are included within the balance sheets. The Company must assess the likelihood that the deferred tax assets will be recovered from future taxable income and, to the extent the Company believes that recovery is not likely, a valuation allowance must be established. To the extent the Company establishes a valuation allowance or increase or decrease to this allowance in a period, the impact will be included in income tax expense in the statements of operations. As of December 31, 2022 and 2021, the Company has established a 100 The Company accounts for income taxes under the provisions of ASC 740 - Income Taxes. As of December 31, 2022 and 2021, there were no unrecognized tax benefits included in the balance sheets that would, if recognized, affect the effective tax rate. The Company’s practice is to recognize interest and penalties related to income tax matters in income tax expense. The Company had no accrual for interest or penalties in its balance sheets at December 31, 2022 or 2021, and has not recognized interest and penalties in the statements of operations for the years ended December 31, 2022, 2021 and 2020. As of December 31, 2022, the Company is subject to taxation in the United States and certain individual states – primarily Illinois and Tennessee. The Company’s tax losses from 2017 through 2022 are subject to examination by the federal and state tax authorities due to the carryforward of unutilized net operating losses (“NOLs”). Current accounting standards include guidance on the accounting for uncertainty in income taxes recognized in the financial statements. Such standards also prescribe a recognition threshold and measurement model for the financial statement recognition of a tax position taken, or expected to be taken, and provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. The Company believes that the ultimate deductibility of all tax positions is highly certain, although there is uncertainty about the timing of such deductibility. As a result, no liability for uncertain tax positions was recorded as of December 31, 2022 or 2021. 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 Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) Note 3 — Summary of Significant Accounting Policies (continued) 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 takes 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. The Company’s financial instruments included cash and cash equivalents, accounts receivable, accounts payable, accrued liabilities and long-term debt obligation. 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. Based on borrowing rates currently available to the Company, the carrying value of the long-term debt obligation approximate their respective fair values. Impact of New Accounting Pronouncements There were no new accounting pronouncements issued by the Financial Accounting Standards Board (“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 | 12 Months Ended |
Dec. 31, 2022 | |
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 December 31, December 31, Computer hardware and software $ 177 $ 157 Furniture and fixtures 112 106 Equipment 52 132 Leasehold improvements 71 71 Construction in progress 12 — Property and equipment, gross 424 466 Less: accumulated depreciation and amortization (352 ) (351 ) Property and equipment, net $ 72 $ 115 Depreciation expense for the years ended December 31, 2022, 2021 and 2020 was $ 66 155 347 Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) |
Debt
Debt | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Debt | Note 5 – 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 The Company was required to maintain a minimum cash balance of $ 3,000 In connection with the initial $ 5,000 51,239 5.86 51,239 226 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 are subject to 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. On April 5, 2022, the Company and SWK entered into an amendment to the SWK Credit Agreement which allowed for a deferral of loan principal payments until May 2023 and reduced the interest rate to LIBOR 3-month plus 8.0 2.0 1,033 The Company recorded interest expense of $ 955 1,042 884 127 148 121 231 134 Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) Note 5 – Debt (continued) The table below reflects the future annual payments for the SWK loan principal and interest as of December 31, 2022. Schedule of Future Payments of Long Term Debt Amount 2023 $ 1,853 2024 6,595 Total payments 8,448 Less: amount representing interest (1,833 ) Loan payable, gross 6,615 Less: current portion of long-term debt (1,033 ) Less: unamortized discount (198 ) Long-term debt, net of unamortized discount $ 5,384 PPP loan On May 4, 2020, the Company received $ 361 4 365 EIDL loan On July 21, 2020, the Company received $ 150 |
Common Stock
Common Stock | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Common Stock | Note 6 — Common Stock The Company has 50,000,000 0.001 In March and April 2020, the Company entered into securities purchase agreements with various investors and sold an aggregate of 2,600,000 3.00 7,756 In March 2020, the Company issued 379,474 1,264 In October 2020, the Company issued 3,220,000 7.00 21,026 Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) Note 6 — Common Stock (continued) For the years ended December 31, 2022 and 2021, the Company issued 25,000 144,233 69,884 49,155 15,190 25 100 25,000 1,067,242 632,231 |
Common Stock Warrants
Common Stock Warrants | 12 Months Ended |
Dec. 31, 2022 | |
Common Stock Warrants | |
Common Stock Warrants | Note 7 — Common Stock Warrants Listed below is a summary of warrants outstanding as of December 31, 2022: Summary of Warrants Outstanding Description of Warrants No. of Shares Exercise Price 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 483,380 $ 7.29 The holders of these warrants or their permitted transferees, are entitled to rights with respect to the registration under the Securities Act of 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. On June 26, 2022, 467,242 3.00 December 26, 2022 244 A rollforward of the warrants outstanding is listed in the table below: Summary of Rollforward of The Warrants Outstanding No. of Shares Balance as of the beginning of the year 1,554,826 Exercise of Placement Agent Warrants – 2017 Preferred Stock Offering (1,067,242 ) Expiration of Placement Agent Warrants – 2017 Preferred Stock Offering (4,204 ) Balance as of the end of the year 483,380 There were 1,067,242 632,231 135,650 94,808 2,367 806 |
Share-Based Payment Awards
Share-Based Payment Awards | 12 Months Ended |
Dec. 31, 2022 | |
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 5,000,000 239,167 Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) Note 8 — Share-Based Payment Awards (continued) 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 by 4 704,317 17,607,928 715,099 17,877,486 972,512 24,312,808 985,040 24,626,004 In April 2020, the Company issued 15,190 25 100 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 In July 2022 and September 2022, the Company’s board of directors approved modifications of certain outstanding awards of two senior executives, one of whom retired in May 2022 and the other whose employment was terminated in July 2022. The combined awards had an exercise price range of $ 1.37 8.61 104 For the years ended December 31, 2022, 2021, and 2020, the Company’s total stock-based compensation expense was $ 4,218 3,381 2,576 3,954 2,838 2,295 264 543 281 Stock Options The following table summarizes stock option activity during the year ended December 31, 2022: Summary of Stock Option Activity Shares Weighted Average Exercise Weighted Average Remaining Aggregate Intrinsic Options outstanding as of January 1, 2022 3,513,719 $ 5.22 Issued 1,333,770 3.72 Exercised (25,000 ) 1.38 Forfeited/Cancelled (420,197 ) 6.04 Options outstanding as of December 31, 2022 4,402,292 $ 4.71 7.5 $ 884 Options exercisable at December 31, 2022 3,037,846 $ 4.68 7.0 $ 800 Options vested and expected to vest at December 31, 2022 4,352,292 $ 4.74 7.5 $ 812 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 December 31. The intrinsic value of the options exercised during 2022 was $ 31 Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) Note 8 — Share-Based Payment Awards (continued) There were 25,000 35 The assumptions used to calculate the fair value of options granted during the years ended December 31, , 2022, 2021, and 2020 under the BSM were as follows: Schedule of Assumptions Used to Calculate Fair Value of Options Granted December 31, 2022 December 31, 2021 December 31, 2020 Expected dividends — % — % — % Expected volatility 70 % 70 80 % 95 % Risk-free interest rate 1.5 3.9 0.9 1.4 % 0.4 0.7 % Expected term 5.9 6.0 5.9 Weighted average fair value $ 2.32 $ 5.64 $ 3.06 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 10 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 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. The Company has also applied some limited weighting to its own volatility. 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. As of December 31, 2022, there was a total of $ 3,868 2 Restricted Stock Units (RSUs) The following table summarizes restricted stock unit activity during the year ended December 31, 2022: Summary of Activity for Restricted Stock Awards Number of Units Weighted Average Grant-Date Fair Value Per Unit Outstanding and unvested as of January 1, 2022 — $ — Granted 373,606 $ 2.63 Vested — — Forfeited (4,000 ) $ 2.63 Outstanding and unvested as of December 31, 2022 369,606 $ $2.63 Stock-based compensation related to RSUs was $ 114 858 3.5 Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) Note 8 — Share-Based Payment Awards (continued) Employee Stock Purchase Plan In December 2018, the Company’s board of directors adopted an initial offering of the Company’s common stock under the Company’s ESPP. The Company’s ESPP provides for an initial reserve of 150,000 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, 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 ending on or around June 10 and December 10 each year, subject to a restart feature if the Company’s stock price drops at the end of a six-month period within the twelve-month offering period The Company recorded an expense of $ 128 73 71 69,884 49,155 1.17 2.50 2.32 234 205 23 22 560,296 |
Basic and Diluted Net Loss per
Basic and Diluted Net Loss per Common Share | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Basic and Diluted Net Loss per Common Share | Note 9 — Basic and Diluted Net Loss per Common Share Basic and diluted net loss per share is computed using the weighted average number of shares of common stock outstanding during the period. Common stock equivalents (using the treasury stock and “if converted” method) from stock options, unvested RSAs and RSUs, and warrants at December 31, 2022, 2021, and 2020 were 5,494,153 4,286,687 3,371,489 The following table shows the computation of basic and diluted net loss per common share: Computation of Basic and Diluted Net Loss Per Common Share Year ended December 31, Year ended December 31, Year ended Net loss $ (9,021 ) $ (1,955 ) $ (27,970 ) Weighted average common shares outstanding (basic and diluted) 25,145,657 25,207,299 21,010,058 Net loss per common share (basic and diluted) $ (0.36 ) $ (0.08 ) $ (1.33 ) Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) |
Related-Party Transactions
Related-Party Transactions | 12 Months Ended |
Dec. 31, 2022 | |
Related Party Transactions [Abstract] | |
Related-Party Transactions | Note 10 — Related-Party Transactions Harrow The Chief Executive Officer of Harrow Health, Inc. (“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 shares to the Harrow CEO in April 2021 after his retirement from the Company’s board associated with RSUs that were previously fully vested. As of December 31, 2022, Harrow owned 1,982,000 shares of Eton’s common shares which represents 7.8 % of the Company’s common shares outstanding. In 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 Chief Executive Officer The CEO has a partial interest in a company that the Company has partnered with for its EM-100/Alaway Preservative Free eye allergy 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 from the date of the Eyemax Agreement, subject to successive two-year renewals unless the Company elected to terminate the Eyemax Agreement On February 18, 2019, the Company entered into an Amended and Restated Agreement with Eyemax amending the Sales 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 paid Eyemax two milestone payments: (i) one milestone payment for $ 250 upon regulatory approval in the territory by the FDA of the first single agent product and (ii) one milestone payment for $ 500 following the first commercial sale of the first single agent product in the territory. Following payment of the milestones, the Company is entitled to retain all of the non-royalty transaction revenues and royalties up to $ 2,000 (the “Recovery Amount”). After the Company has retained the full Recovery Amount, it is entitled to retain half of all royalty and non-royalty transaction revenue. The Company has realized $ 1,818 of the non-royalty and royalty revenue as of December 31, 2022. The Amended Agreement also contains customary representations, warranties, covenants and indemnities by the parties. The EM-100 asset and its associated product rights were sold to Bausch Health on February 18, 2019 and future potential royalties of twelve percent on Bausch Health sales of the product, named Alaway ® Preservative Free by Bausch, which was approved by the FDA in September 2020, will be split between Eyemax and the Company. The royalty from Bausch Health is subject to reduction if a competitive product with the same active pharmaceutical ingredient is launched in the U.S. or if the product’s U.S market share falls below a specified target percentage. There were no amounts due to Eyemax under the terms of the Amended Agreement as of Dec ember 31, 2022 or December 31, 2021. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2022 | |
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. On January 12, 2018, the Company signed an amended lease agreement to lease additional office space adjacent to its current corporate office space in Deer Park, Illinois. The amended lease was scheduled to expire at the end of March 2021. In October 2020, the Company renewed its office lease for a two-year period through March 31, 2023 195 195 In November 2022, the Company renewed its office lease for a two-year period through March 31, 2025 188 188 In November 2020, this laboratory lease was extended to June 2021 The Company does not have any lease contracts that contain: (1) an option to extend that the Company is reasonably certain to exercise, (2) an option to terminate that the Company is reasonably certain to exercise, or (3) an option to extend (or not to terminate) in which exercise of the option is controlled by the lessor. Additionally, the Company does not have any leases with residual value guarantees or material restrictive covenants. Lease liabilities and their corresponding right-of-use assets have been recorded based on the present value of the future lease payments over the expected lease term. One of the Company’s lease agreements contains provisions for escalating rent payments over the term of the lease. The Company’s leases do not contain readily determinable implicit discount rates, and therefore, the Company was required to use its incremental borrowing rate of 7.8 5.4 8.6 The Company’s operating lease cost as presented in the “Research and Development” and “General and Administrative” captions in the statements of operations was $ 0 9 55 82 86 84 87 113 139 88 83 82 88 129 2.25 8.6 Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) Note 11 — Leases (continued) The table below presents the lease-related assets and liabilities recorded on the balance sheet as of December 31, 2022: Schedule of Lease-related Assets and Liabilities Assets Classification Operating lease right-of-use assets Operating lease right-of-use assets, net $ 188 Total leased assets $ 188 Liabilities Operating lease liabilities, current Accrued liabilities $ 75 Operating lease liabilities, noncurrent Operating lease liabilities, net of current portion 107 Total operating lease liabilities $ 182 The Company’s future annual lease commitments as of December 31, 2022 are as indicated below: Schedule of Future Lease Commitments Total 2023 2024 2025 Undiscounted lease payments $ 201 $ 88 $ 90 $ 23 Less: Imputed interest (19 ) Total lease liabilities $ 182 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Note 12 – Income Taxes The provision for income taxes for the Company consists of the following for the years ended December 31, 2022, 2021 and 2020: Schedule of Provision for Income Taxes Year ended Year ended Year ended December 31, December 31, December 31, 2022 2021 2020 Current: Federal $ — $ — $ — State — — — Total current expense — — — Deferred: Federal 2,272 460 6,020 State 812 185 2,151 Change in valuation allowance (3,084 ) (645 ) (8,171 ) Total deferred expense — — — Total provision $ — $ — $ — Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) Note 12 – Income Taxes (continued) The significant components of the Company’s deferred tax assets as of December 31, 2022 and 2021 are as follows: Schedule of Deferred Tax Assets December 31, December 31, 2022 2021 Net operating losses $ 17,183 $ 15,871 Stock-based expenses 3,090 2,135 Accruals and other 1,359 542 Total deferred tax assets 21,632 18,548 Valuation allowance (21,632 ) (18,548 ) Net deferred tax assets $ — $ — Based on the uncertainty of future taxable income at this time management believes a 100 21,632 18,548 A reconciliation of the statutory federal tax rate to effective tax rate is shown below: Schedule of Reconciliation of Statutory Federal Tax Rate Year ended December 31 Year ended December 31, Year ended 2022 2021 2020 Benefit at statutory rate (21.0 )% (21.0 )% (21.0 )% Permanent items (primarily warrants and stock compensation) (3.3 ) (2.5 ) (0.5 ) State tax benefit (8.7 ) (9.5 ) (7.7 ) Federal rate change — — — Other items — — — Increase in valuation allowance 33.0 33.0 29.2 Income tax expense — % — % — % The Company has a federal and state NOL carryforward of $ 60,281 54,629 5,652 expire in 2029 In addition, under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, and corresponding provisions of state law, if a corporation undergoes an “ownership change,” which is generally defined as a greater than 50 |
Employee Savings Plan
Employee Savings Plan | 12 Months Ended |
Dec. 31, 2022 | |
Retirement Benefits [Abstract] | |
Employee Savings Plan | Note 13 - Employee Savings Plan The Company established an employee savings plan pursuant to Section 401(k) of the Internal Revenue Code, effective January 1, 2018. The plan allows participating employees to deposit into tax deferred investment accounts up to 100 4 172 154 117 Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Note 14 — 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 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 in 2021. The Company has recognized $ 22,000 5,000 20,000 During the years ended December 31, 2021 and 2020 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 5,000 On January 23, 2019, the Company entered into a Licensing and Supply Agreement (the “Agreement”) with Liquimeds Worldwide (“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 and LMW was responsible for development and manufacturing of ET-104. The Company paid $ 650 to Azurity upon issuance of patent covering ET-104 listed in the FDA’s Orange Book in November 2022 and will pay $ 500 in the event that product sales in excess of $ 10,000 were achieved within a calendar year. 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 in August 2019 upon receiving an acceptance for review letter from the FDA and will pay $ 2,450 upon FDA approval and commercial sales of the product candidate and another $ 1,000 upon issuance of an Orange-book listed patent. If Aucta successfully completes a Lamotrigine product line extension product, Eton will pay $ 1,500 upon FDA acceptance of the product filing. Aucta will be entitled to receive milestone payments from the Company of up to $ 3,000 based on commercial success of the product, including $ 1,000 when net sales exceed $10 million in a calendar year , and $ 2,000 when net sales exceed $20 million in a calendar year . Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) Note 14 — Commitments and Contingencies (continued) Azurity will assume royalty or profit share obligations owed to development partners as well as additional milestone payments based on sales volume targets. On March 27, 2020, the Company entered into an Exclusive Licensing and Supply Agreement (the “Alkindi License Agreement”) with 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 patients with adrenocortical insufficiency. For the initial licensing milestone fee, the Company paid Diurnal $ 3,500 379,474 1,264 3.33 4,764 2,500 On June 15, 2021, the Company acquired U.S. and Canadian rights to Crossject’s ZENEO® hydrocortisone needleless autoinjector, which is under development as a rescue treatment for adrenal crisis. The Company paid Crossject $ 500 500 3,500 6,000 10 On October 28, 2021, the Company acquired the U.S. marketing rights to Carglumic Acid Tablets. The product’s Abbreviated New Drug Application (“ANDA”), which is owned by Novitium Pharma, was approved by the FDA on October 12, 2021. The product is an AB-rated, substitutable generic version of Carbaglu®. The Company paid $ 3,250 upon signing and retains 50 % of the product profits with the balance being distributed to the licensor and manufacturer. The Company launched this product in December 2021. In June 2022, the Company sold its rights in Cysteine Hydrochloride, Biorphen®, and Rezipres® to Dr. Reddy’s. Under the terms of the transaction, Dr. Reddy’s assumed immediate ownership of Eton’s rights and interest in the products. The Company received $ 5,000 42,500 5,000 250 10 812 On September 13, 2022, the Company acquired an FDA-approved ANDA for Betaine Anhydrous for oral solution. The ANDA was approved by the FDA on January 28, 2022. The Company paid $ 2,000 1,000 65 Indemnification As permitted under Delaware law and in accordance with the Company’s Amended and Restated Bylaws, the Company is required to indemnify its officers and directors for certain events or occurrences while the officer or director is or was serving in such capacity. The Company is also party to indemnification agreements with its directors and officers. The Company believes the fair value of the indemnification rights and agreements is minimal. Accordingly, the Company has not recorded any liabilities for these indemnification rights and agreements as of December 31, 2022 or 2021. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The Company has prepared the accompanying financial statements in accordance with GAAP. Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) Note 3 — Summary of Significant Accounting Policies (continued) |
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 at 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, chargebacks and sales returns, valuation of inventories, useful lives of assets and the impairment of property and equipment, deferred tax assets, the accrual of research and development expenses and the valuation of common stock, stock options and warrants, and restricted stock units (“RSUs”). 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 money market funds. From time to time, amounts deposited with its bank exceed federally insured limits. 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 $ 262 96 |
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. Inventories at December 31, 2022 and 2021 consist solely of purchased finished goods. At December 31, 2022, inventories are shown net of a reserve for damaged Biorphen inventory yet to be destroyed and net of ALKINDI SPRINKLE® inventory at risk of expiry prior to being sold. At December 31, 2021, inventories are shown net of a reserve for Biorphen inventory due to the risk of expiry prior to being sold. There was an inventory reserve of $ 62 1,414 |
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 Maintenance and repairs are charged to expense as incurred, while renewals and improvements are capitalized. Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) Note 3 — Summary of Significant Accounting Policies (continued) |
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. In November 2021, the Company purchased the rights for its Carglumic Acid product for $ 3,250 ten years 750 five years 275 75 750 five years 738 2,000 five years 1,996 1,617 204 150 204 150 Schedule of Intangible Assets Amortization Expenses Year Amortization Expense 2023 $ 725 2024 725 2025 725 2026 725 2027 608 Thereafter 1,246 Total estimated amortization expense $ 4,754 |
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 impairment was recognized during the years ended December 31, 2022, 2021 and 2020. |
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. Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) Note 3 — Summary of Significant Accounting Policies (continued) |
Leases | Leases The Company accounts for leases in accordance with ASC Topic 842 — Leases. The Company reviews all relevant facts and circumstances of a contract to determine if it is a lease whereby the terms of the agreement convey the right to control the direct use and receive substantially all the economic benefits of an identified asset for a period of time in exchange for consideration. The associated right-of-use assets and lease liabilities are recognized at lease commencement. The Company measures lease liabilities based on the present value of the lease payments over the lease term discounted using the rate it would pay on a loan with the equivalent payments and term for the lease. The Company does not include the impact for lease term options that would extend or terminate the lease unless it is reasonably certain that it will exercise any such options. The Company accounts for the lease components separately from non-lease components for its operating leases. The Company measures right-of-use assets based on the corresponding lease liabilities adjusted for (i) any prepayments made to the lessor at or before the commencement date, (ii) initial direct costs it incurs, and (iii) any incentives under the lease. In addition, the Company evaluates the recoverability of its right-of-use assets for possible impairment in accordance with its long-lived assets policy. Operating leases are reflected on the balance sheets as operating lease right-of-use assets, current accrued liabilities and long-term operating lease liabilities. The Company does no The Company commences recognizing operating lease expense when the lessor makes the underlying asset available for use by the Company and the operating lease expense is recognized on a straight-line basis over the term of the lease. Variable lease payments are expensed as incurred. The Company does not recognize right-of-use assets or lease liabilities for leases with a term of twelve months or less; such lease costs are recorded in the statements of operations on a straight-line basis over the lease term. |
Patent Costs | Patent Costs All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed as incurred due to the uncertainty about the successful award of a patent and the recovery of the expenditure. Amounts incurred are classified as general and administrative expenses. |
Concentrations of Credit Risk, Sources of Supply and Significant Customers | Concentrations of Credit Risk, Sources of Supply and Significant Customers The Company is subject to credit risk for its cash and cash equivalents which are invested in money market funds and U.S. treasury bills from time to time. The Company maintains its cash and cash equivalent balances with one major commercial bank and the deposits held with the financial institution exceed the amount of insurance provided on such deposits and is exposed to credit risk in the event of a default by the financial institutions holding its cash and cash equivalents to the extent recorded on the balance sheets. The Company believes the associated credit risk to be minimal. The Company is dependent on third-party suppliers for its products and product candidates. In particular, the Company relies, and expects to continue to rely, on a small number of suppliers to manufacture key chemicals, approved products and process its product candidates as part of its development programs. These programs could be adversely affected by a significant interruption in the manufacturing process. Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) Note 3 — Summary of Significant Accounting Policies (continued) The Company is also subject to credit risk from its accounts receivable related to product sales as it extends credit based on an evaluation of the customer’s financial condition, and collateral is not required. Management monitors its exposure to accounts receivable by periodically evaluating the collectability of the account receivable based on a variety of factors including the length of time the receivables are past due, the financial health of the customer and historical experience. Based upon the review of these factors, the Company recorded no allowance for doubtful accounts at December 31, 2022 or 2021. The accounts receivable balance at December 31, 2022 and 2021 and product sales revenue recognized during the year ended December 31, 2022 and 2021 consist of sales to and amounts due from AmerisourceBergen Corporation, Cardinal Health Services and McKesson Corporation for sales of the Company’s Biorphen product. The December 31, 2022 accounts receivable balance and sales in 2022 also include amounts due from AnovoRx for sales of the Company’s ALKINDI SPRINKLE® product and its Carglumic Acid product. AnovoRx sales made up 45.5 79.8 9.0 6.4 |
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. 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 Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) Note 3 — Summary of Significant Accounting Policies (continued) Royalties – Significant Financing Component – The Company sells its ALKINDI SPRINKLE® and Carglumic Acid product to one pharmacy distributor customer which provides order fulfilment and inventory storage/distribution services. The Company may sell products 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 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. For its ALKINDI SPRINKLE® and Carglumic Acid products, 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. Selling prices initially billed to wholesalers are subject to discounts for prompt payment and subsequent chargebacks when the wholesalers sell products at negotiated discounted prices to members of certain group purchasing organizations (“GPOs”) and government programs. Because of the shelf life of the product 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. 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 and the impact of other discounts and fees it pays, although ALKINDI SPRINKLE® and Carglumic Acid sales 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 stores its ALKINDI SPRINKLE® and Carglumic Acid inventory at its pharmacy distributor customer location, and sales are recorded when stock is pulled and shipped to fulfill specific patient orders. The Company recognizes revenue and cost of sales from products sold to wholesalers upon 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. 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 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 anticipates it will receive revenues from product licensing agreements where it has contracted for milestone payments and royalties from products it has developed or acquired. Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) Note 3 — Summary of Significant Accounting Policies (continued) |
Cost of Product Sales | Cost of Product Sales Cost of product 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, the amortization of certain intangible assets, 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. |
Income (Loss) Per Share | Income (Loss) Per Share Basic net income (loss) per common share is computed by dividing net income (loss) attributable to common stockholders for the period by the weighted average number of common shares outstanding during the period. Diluted net income (loss) per share is computed by dividing the net income (loss) attributable to common stockholders for the period by the weighted average number of common and common equivalent shares, such as Series A Preferred, unvested restricted stock, stock options and warrants that are outstanding during the period. Common stock equivalents are excluded from the computation when their inclusion would be anti-dilutive. No such adjustments were made for 2022, 2021 or 2020 as the Company reported a net loss for the years ended December 31, 2022, 2021 and 2020 and including the effects of common stock equivalents in the diluted earnings per share calculation would have been anti-dilutive (see Note 9). |
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, 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. The Company uses the closing common stock price on the date of grant for the fair value of the common stock. Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) Note 3 — Summary of Significant Accounting Policies (continued) |
Income Taxes | Income Taxes As part of the process of preparing the Company’s financial statements, the Company must estimate the actual current tax liabilities and assess temporary differences resulting from differing treatment of items for tax and accounting purposes. These differences result in deferred tax assets and liabilities, which are included within the balance sheets. The Company must assess the likelihood that the deferred tax assets will be recovered from future taxable income and, to the extent the Company believes that recovery is not likely, a valuation allowance must be established. To the extent the Company establishes a valuation allowance or increase or decrease to this allowance in a period, the impact will be included in income tax expense in the statements of operations. As of December 31, 2022 and 2021, the Company has established a 100 The Company accounts for income taxes under the provisions of ASC 740 - Income Taxes. As of December 31, 2022 and 2021, there were no unrecognized tax benefits included in the balance sheets that would, if recognized, affect the effective tax rate. The Company’s practice is to recognize interest and penalties related to income tax matters in income tax expense. The Company had no accrual for interest or penalties in its balance sheets at December 31, 2022 or 2021, and has not recognized interest and penalties in the statements of operations for the years ended December 31, 2022, 2021 and 2020. As of December 31, 2022, the Company is subject to taxation in the United States and certain individual states – primarily Illinois and Tennessee. The Company’s tax losses from 2017 through 2022 are subject to examination by the federal and state tax authorities due to the carryforward of unutilized net operating losses (“NOLs”). Current accounting standards include guidance on the accounting for uncertainty in income taxes recognized in the financial statements. Such standards also prescribe a recognition threshold and measurement model for the financial statement recognition of a tax position taken, or expected to be taken, and provides guidance on derecognition, classification, interest and penalties, accounting in interim periods, disclosure and transition. The Company believes that the ultimate deductibility of all tax positions is highly certain, although there is uncertainty about the timing of such deductibility. As a result, no liability for uncertain tax positions was recorded as of December 31, 2022 or 2021. |
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 Eton Pharmaceuticals, Inc. NOTES TO FINANCIAL STATEMENTS ( in thousands, except share and per share amounts) Note 3 — Summary of Significant Accounting Policies (continued) 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 takes 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. The Company’s financial instruments included cash and cash equivalents, accounts receivable, accounts payable, accrued liabilities and long-term debt obligation. 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. Based on borrowing rates currently available to the Company, the carrying value of the long-term debt obligation approximate their respective fair values. |
Impact of New Accounting Pronouncements | Impact of New Accounting Pronouncements There were no new accounting pronouncements issued by the Financial Accounting Standards Board (“FASB”) during the current period that would apply to the Company and have a material impact on its financial position or results of operations. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule of Intangible Assets Amortization Expenses | Schedule of Intangible Assets Amortization Expenses Year Amortization Expense 2023 $ 725 2024 725 2025 725 2026 725 2027 608 Thereafter 1,246 Total estimated amortization expense $ 4,754 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consist of the following: Schedule of Property and Equipment December 31, December 31, Computer hardware and software $ 177 $ 157 Furniture and fixtures 112 106 Equipment 52 132 Leasehold improvements 71 71 Construction in progress 12 — Property and equipment, gross 424 466 Less: accumulated depreciation and amortization (352 ) (351 ) Property and equipment, net $ 72 $ 115 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of Future Payments of Long Term Debt | The table below reflects the future annual payments for the SWK loan principal and interest as of December 31, 2022. Schedule of Future Payments of Long Term Debt Amount 2023 $ 1,853 2024 6,595 Total payments 8,448 Less: amount representing interest (1,833 ) Loan payable, gross 6,615 Less: current portion of long-term debt (1,033 ) Less: unamortized discount (198 ) Long-term debt, net of unamortized discount $ 5,384 |
Common Stock Warrants (Tables)
Common Stock Warrants (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Common Stock Warrants | |
Summary of Warrants Outstanding | Listed below is a summary of warrants outstanding as of December 31, 2022: Summary of Warrants Outstanding Description of Warrants No. of Shares Exercise Price 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 483,380 $ 7.29 |
Summary of Rollforward of The Warrants Outstanding | A rollforward of the warrants outstanding is listed in the table below: Summary of Rollforward of The Warrants Outstanding No. of Shares Balance as of the beginning of the year 1,554,826 Exercise of Placement Agent Warrants – 2017 Preferred Stock Offering (1,067,242 ) Expiration of Placement Agent Warrants – 2017 Preferred Stock Offering (4,204 ) Balance as of the end of the year 483,380 |
Share-Based Payment Awards (Tab
Share-Based Payment Awards (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Stock Option Activity | The following table summarizes stock option activity during the year ended December 31, 2022: Summary of Stock Option Activity Shares Weighted Average Exercise Weighted Average Remaining Aggregate Intrinsic Options outstanding as of January 1, 2022 3,513,719 $ 5.22 Issued 1,333,770 3.72 Exercised (25,000 ) 1.38 Forfeited/Cancelled (420,197 ) 6.04 Options outstanding as of December 31, 2022 4,402,292 $ 4.71 7.5 $ 884 Options exercisable at December 31, 2022 3,037,846 $ 4.68 7.0 $ 800 Options vested and expected to vest at December 31, 2022 4,352,292 $ 4.74 7.5 $ 812 |
Schedule of Assumptions Used to Calculate Fair Value of Options Granted | The assumptions used to calculate the fair value of options granted during the years ended December 31, , 2022, 2021, and 2020 under the BSM were as follows: Schedule of Assumptions Used to Calculate Fair Value of Options Granted December 31, 2022 December 31, 2021 December 31, 2020 Expected dividends — % — % — % Expected volatility 70 % 70 80 % 95 % Risk-free interest rate 1.5 3.9 0.9 1.4 % 0.4 0.7 % Expected term 5.9 6.0 5.9 Weighted average fair value $ 2.32 $ 5.64 $ 3.06 |
Summary of Activity for Restricted Stock Awards | The following table summarizes restricted stock unit activity during the year ended December 31, 2022: Summary of Activity for Restricted Stock Awards Number of Units Weighted Average Grant-Date Fair Value Per Unit Outstanding and unvested as of January 1, 2022 — $ — Granted 373,606 $ 2.63 Vested — — Forfeited (4,000 ) $ 2.63 Outstanding and unvested as of December 31, 2022 369,606 $ $2.63 |
Basic and Diluted Net Loss pe_2
Basic and Diluted Net Loss per Common Share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Net Loss Per Common Share | The following table shows the computation of basic and diluted net loss per common share: Computation of Basic and Diluted Net Loss Per Common Share Year ended December 31, Year ended December 31, Year ended Net loss $ (9,021 ) $ (1,955 ) $ (27,970 ) Weighted average common shares outstanding (basic and diluted) 25,145,657 25,207,299 21,010,058 Net loss per common share (basic and diluted) $ (0.36 ) $ (0.08 ) $ (1.33 ) |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
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 December 31, 2022: Schedule of Lease-related Assets and Liabilities Assets Classification Operating lease right-of-use assets Operating lease right-of-use assets, net $ 188 Total leased assets $ 188 Liabilities Operating lease liabilities, current Accrued liabilities $ 75 Operating lease liabilities, noncurrent Operating lease liabilities, net of current portion 107 Total operating lease liabilities $ 182 |
Schedule of Future Lease Commitments | The Company’s future annual lease commitments as of December 31, 2022 are as indicated below: Schedule of Future Lease Commitments Total 2023 2024 2025 Undiscounted lease payments $ 201 $ 88 $ 90 $ 23 Less: Imputed interest (19 ) Total lease liabilities $ 182 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of Provision for Income Taxes | The provision for income taxes for the Company consists of the following for the years ended December 31, 2022, 2021 and 2020: Schedule of Provision for Income Taxes Year ended Year ended Year ended December 31, December 31, December 31, 2022 2021 2020 Current: Federal $ — $ — $ — State — — — Total current expense — — — Deferred: Federal 2,272 460 6,020 State 812 185 2,151 Change in valuation allowance (3,084 ) (645 ) (8,171 ) Total deferred expense — — — Total provision $ — $ — $ — |
Schedule of Deferred Tax Assets | The significant components of the Company’s deferred tax assets as of December 31, 2022 and 2021 are as follows: Schedule of Deferred Tax Assets December 31, December 31, 2022 2021 Net operating losses $ 17,183 $ 15,871 Stock-based expenses 3,090 2,135 Accruals and other 1,359 542 Total deferred tax assets 21,632 18,548 Valuation allowance (21,632 ) (18,548 ) Net deferred tax assets $ — $ — |
Schedule of Reconciliation of Statutory Federal Tax Rate | A reconciliation of the statutory federal tax rate to effective tax rate is shown below: Schedule of Reconciliation of Statutory Federal Tax Rate Year ended December 31 Year ended December 31, Year ended 2022 2021 2020 Benefit at statutory rate (21.0 )% (21.0 )% (21.0 )% Permanent items (primarily warrants and stock compensation) (3.3 ) (2.5 ) (0.5 ) State tax benefit (8.7 ) (9.5 ) (7.7 ) Federal rate change — — — Other items — — — Increase in valuation allowance 33.0 33.0 29.2 Income tax expense — % — % — % |
Liquidity Considerations (Detai
Liquidity Considerations (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||
Accumulated deficit | $ 103,134 | $ 94,113 | |
Net loss | 9,021 | 1,955 | $ 27,970 |
Cash and cash equivalents | $ 16,305 | $ 14,406 |
Schedule of Intangible Assets A
Schedule of Intangible Assets Amortization Expenses (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Accounting Policies [Abstract] | |
2023 | $ 725 |
2024 | 725 |
2025 | 725 |
2026 | 725 |
2027 | 608 |
Thereafter | 1,246 |
Total estimated amortization expense | $ 4,754 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Details Narrative) | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||
Sep. 30, 2022 USD ($) | Nov. 30, 2021 USD ($) | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) Segment | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Dec. 31, 2019 USD ($) | Jun. 30, 2022 USD ($) | |
Product Information [Line Items] | ||||||||
Number of reportable segments | Segment | 1 | |||||||
Allowances for doubtful accounts | $ 262,000 | $ 96,000 | ||||||
Inventory write-down | 62,000 | 1,414,000 | ||||||
Payments to acquire intangible assets | 2,750,000 | 3,250,000 | ||||||
Accumulated amortization | 1,996,000 | |||||||
Amortization of intangible assets | 1,617,000 | 204,000 | $ 150,000 | |||||
Finance lease | $ 0 | $ 0 | ||||||
Percentage for valuation reserve against deferred tax assets | 100% | 100% | ||||||
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Customers [Member] | ||||||||
Product Information [Line Items] | ||||||||
Concentration risk, percentage | 45.50% | 9% | ||||||
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Customers [Member] | ||||||||
Product Information [Line Items] | ||||||||
Concentration risk, percentage | 79.80% | 6.40% | ||||||
Betaine Anhydrous Product [Member] | ||||||||
Product Information [Line Items] | ||||||||
Payments to acquire intangible assets | $ 2,000,000 | |||||||
Finite-lived intangible asset, useful life | 5 years | |||||||
Carglumic Acid Product Rights [Member] | ||||||||
Product Information [Line Items] | ||||||||
Payments to acquire intangible assets | $ 3,250,000 | |||||||
Finite-lived intangible asset, useful life | 10 years | |||||||
Biorphen Product [Member] | ||||||||
Product Information [Line Items] | ||||||||
Payments to acquire intangible assets | $ 750,000 | |||||||
Finite-lived intangible asset, useful life | 5 years | |||||||
Biorphen [Member] | ||||||||
Product Information [Line Items] | ||||||||
Accumulated amortization | $ 75,000 | $ 275,000 | ||||||
Rezipres Product [Member] | ||||||||
Product Information [Line Items] | ||||||||
Payments to acquire intangible assets | $ 750,000 | |||||||
Finite-lived intangible asset, useful life | 5 years | |||||||
Dr Reddys [Member] | ||||||||
Product Information [Line Items] | ||||||||
Accumulated amortization | $ 738,000 | |||||||
Computer Equipment [Member] | ||||||||
Product Information [Line Items] | ||||||||
Estimated useful lives for property and equipment | 3 years | |||||||
Furniture and Fixtures [Member] | ||||||||
Product Information [Line Items] | ||||||||
Estimated useful lives for property and equipment | 5 years |
Schedule of Property and Equipm
Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Abstract] | ||
Computer hardware and software | $ 177 | $ 157 |
Furniture and fixtures | 112 | 106 |
Equipment | 52 | 132 |
Leasehold improvements | 71 | 71 |
Construction in progress | 12 | |
Property and equipment, gross | 424 | 466 |
Less: accumulated depreciation and amortization | (352) | (351) |
Property and equipment, net | $ 72 | $ 115 |
Property and Equipment (Details
Property and Equipment (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Property, Plant and Equipment [Abstract] | |||
Depreciation and amortization expense | $ 66 | $ 155 | $ 347 |
Schedule of Future Payments of
Schedule of Future Payments of Long Term Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Debt Disclosure [Abstract] | ||
2023 | $ 1,853 | |
2024 | 6,595 | |
Total payments | 8,448 | |
Less: amount representing interest | (1,833) | |
Loan payable, gross | 6,615 | |
Less: current portion of long-term debt | (1,033) | $ (1,418) |
Less: unamortized discount | (198) | |
Long-term debt, net of unamortized discount | $ 5,384 | $ 5,262 |
Debt (Details Narrative)
Debt (Details Narrative) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||||||||
Apr. 05, 2022 | May 20, 2021 USD ($) | Aug. 11, 2020 USD ($) | Jul. 21, 2020 USD ($) | May 04, 2020 USD ($) | Nov. 13, 2019 USD ($) | Aug. 31, 2020 USD ($) $ / shares shares | Nov. 30, 2019 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) $ / shares shares | Dec. 31, 2021 USD ($) shares | Dec. 31, 2020 USD ($) | Jun. 26, 2022 $ / shares shares | |
Debt Instrument [Line Items] | ||||||||||||
Borrowing amount | $ 2,000 | $ 2,000 | ||||||||||
Warrants issued to purchase common stock | shares | 483,380 | 1,554,826 | 467,242 | |||||||||
Warrants exercise price | $ / shares | $ 7.29 | $ 3 | ||||||||||
Interest expenses | $ 955 | $ 1,042 | $ 884 | |||||||||
Debt discount amortization | 127 | 148 | 121 | |||||||||
Accrued interest | 231 | 134 | ||||||||||
Proceeds from loan | 511 | |||||||||||
Gain on debt extinguishment | 365 | |||||||||||
PPP Loan [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Interest expenses | $ 4 | |||||||||||
Proceeds from loan | $ 361 | |||||||||||
Gain on debt extinguishment | $ 365 | |||||||||||
EIDL Loan [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Proceeds from loan | $ 150 | |||||||||||
London Interbank Offered Rate (LIBOR) [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
LIBOR interest rate | 8% | |||||||||||
Principal amount | $ 1,033 | |||||||||||
LIBOR Floor Rate [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
LIBOR interest rate | 2% | |||||||||||
Warrant [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Borrowing amount | $ 2,000 | $ 5,000 | ||||||||||
Warrants issued to purchase common stock | shares | 18,141 | 51,239 | ||||||||||
Warrants exercise price | $ / shares | $ 6.62 | $ 5.86 | ||||||||||
Warrants, fair value | $ 94 | $ 226 | ||||||||||
Warrants expiration term | 7 years | 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 | ||||||||||
Food and Drug Administration's [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Borrowing amount | 3,000 | |||||||||||
SWK Credit Agreement [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Proceeds amount | $ 5,000 | |||||||||||
Interest rate | 5% | |||||||||||
DebtInstrument description | The Company was required to maintain a minimum cash balance of $3,000, only pay interest on the debt until February 2022 and then pay 5.5% of the loan principal balance commencing on February 15, 2022 and then every three months thereafter until November 13, 2024 at which time the remaining principal balance is due. Borrowings under the SWK Credit Agreement are secured by the Company’s assets. 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 | |||||||||||
Minimum cash balance | $ 3,000 | |||||||||||
SWK Credit Agreement [Member] | Unused lines of Credit [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Interest rate | 2% | |||||||||||
SWK Credit Agreement [Member] | London Interbank Offered Rate (LIBOR) Swap Rate [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Interest rate | 10% | |||||||||||
SWK Credit Agreement [Member] | Stated LIBOR Floor Rate [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Interest rate | 2% | |||||||||||
SWK Credit Agreement [Member] | Food and Drug Administration's [Member] | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Proceeds 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 | 12 Months Ended | |||||
Apr. 30, 2021 | Oct. 31, 2020 | Apr. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Subsidiary, Sale of Stock [Line Items] | |||||||
Common stock, shares authorized | 50,000,000 | 50,000,000 | |||||
Common stock, par value | $ 0.001 | $ 0.001 | |||||
Value of common stock shares issued | $ 28,782 | ||||||
Warrant [Member] | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Number of stock issued for exercise of stock warrants | 1,067,242 | ||||||
Common Stock [Member] | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Number of common stock shares issued | 94,808 | 5,820,000 | |||||
Value of common stock shares issued | $ 6 | ||||||
Stock issued during period shares stock options exercised | 25,000 | 144,233 | 194,878 | ||||
Shares issued, shares, share-based payment arrangement, after forfeiture | 15,190 | ||||||
Number of stock issued for exercise of stock warrants | 632,231 | ||||||
Employee Stock Purchase Plan [Member] | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Stock issued during period shares stock options exercised | 69,884 | 49,155 | |||||
RSA To New Employee [Member] | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Shares issued, shares, share-based payment arrangement, after forfeiture | 15,190 | ||||||
Share based compensation arrangement by sharebased payment award purchase price of common stock percent | 100% | 25% | |||||
Board of Directors [Member] | Restricted Stock Units (RSUs) [Member] | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Number of common stock shares issued | 25,000 | ||||||
2018 Equity Incentive Plan [Member] | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Stock issued during period shares stock options exercised | 25,000 | 144,233 | |||||
IPO [Member] | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Number of common stock shares issued | 3,220,000 | ||||||
Common stock share price per share | $ 7 | ||||||
Net cash proceeds from initial public offering | $ 21,026 | ||||||
Diurnal Limited [Member] | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Number of common stock shares issued | 379,474 | ||||||
Value of common stock shares issued | $ 1,264 | ||||||
Securities Purchase Agreements [Member] | |||||||
Subsidiary, Sale of Stock [Line Items] | |||||||
Sale of stock, number of shares issued in transaction | 2,600,000 | 2,600,000 | |||||
Sale of stock, price per share | $ 3 | $ 3 | |||||
Proceeds from sale of stock, consideration received on transaction | $ 7,756 | $ 7,756 |
Summary of Warrants Outstanding
Summary of Warrants Outstanding (Details) - $ / shares | Dec. 31, 2022 | Jun. 26, 2022 | Dec. 31, 2021 |
No. of Shares | 483,380 | 467,242 | 1,554,826 |
Exercise Price | $ 7.29 | $ 3 | |
Placement Agent Warrants - IPO [Member] | |||
No. of Shares | 414,000 | ||
Exercise Price | $ 7.50 | ||
SWK Warrants Debt (Tranche #1) [Member] | |||
No. of Shares | 51,239 | ||
Exercise Price | $ 5.86 | ||
SWK Warrants Debt (Tranche #2) [Member] | |||
No. of Shares | 18,141 | ||
Exercise Price | $ 6.62 |
Summary of Rollforward of The W
Summary of Rollforward of The Warrants Outstanding (Details) | 12 Months Ended |
Dec. 31, 2022 shares | |
Common Stock Warrants | |
Balance as of the beginning of the year | 1,554,826 |
Exercise of Placement Agent Warrants - 2017 Preferred Stock Offering | (1,067,242) |
Exercise of Placement Agent Warrants - 2017 Preferred Stock Offering | (4,204) |
Balance as of the end of the year | 483,380 |
Common Stock Warrants (Details
Common Stock Warrants (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Jun. 26, 2022 | |
Issuance of warrants | 483,380 | 1,554,826 | 467,242 | |
Exercise price of warrants | $ 7.29 | $ 3 | ||
Warrant expiration date | Dec. 26, 2022 | |||
Modification expense | $ 104 | |||
Exercise of placement agent warrant | 1,067,242 | 135,650 | ||
Warrant exercised | $ 2,367 | $ 806 | ||
Common Stock [Member] | ||||
Number of stock issued for exercise of stock warrants | 632,231 | 94,808 | ||
Common stock issued | 94,808 | 5,820,000 | ||
General and Administrative Expense [Member] | ||||
Modification expense | $ 244 |
Summary of Stock Option Activit
Summary of Stock Option Activity (Details) - Equity Option [Member] $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) $ / shares shares | |
Offsetting Assets [Line Items] | |
Shares, Options Outstanding, Beginning Balance | shares | 3,513,719 |
Weighted Average Exercise Price, Options Outstanding, Beginning Balance | $ / shares | $ 5.22 |
Shares, Issued | shares | 1,333,770 |
Weighted Average Exercise Price, Issued | $ / shares | $ 3.72 |
Shares, Exercised | shares | (25,000) |
Weighted Average Exercise Price, Exercised | $ / shares | $ 1.38 |
Shares, Forfeited/Cancelled | shares | (420,197) |
Weighted Average Exercise Price, Forfeited/Cancelled | $ / shares | $ 6.04 |
Shares, Options Outstanding, Ending Balance | shares | 4,402,292 |
Weighted Average Exercise Price, Options Outstanding, Ending Balance | $ / shares | $ 4.71 |
Weighted Average Remaining Contractual Term, Options Outstanding, Ending Balance | 7 years 6 months |
Aggregate Intrinsic Value, Options Outstanding, Ending Balance | $ | $ 884 |
Shares, Options Exercisable, Ending Balance | shares | 3,037,846 |
Weighted Average Exercise Price, Options Exercisable, Ending Balance | $ / shares | $ 4.68 |
Weighted Average Remaining Contractual Term, Options Exercisable, Ending Balance | 7 years |
Aggregate Intrinsic Value, Options Exercisable, Ending Balance | $ | $ 800 |
Shares, Options Vested and Expected to Vest, Ending Balance | shares | 4,352,292 |
Weighted Average Exercise Price, Options Vested and Expected to Vest, Ending Balance | $ / shares | $ 4.74 |
Weighted Average Remaining Contractual Term, Options Vested and Expected to Vest, Ending Balance | 7 years 6 months |
Aggregate Intrinsic Value, Options Vested and Expected to Vest, Ending Balance | $ | $ 812 |
Schedule of Assumptions Used to
Schedule of Assumptions Used to Calculate Fair Value of Options Granted (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-Based Payment Arrangement [Abstract] | |||
Expected dividends | |||
Expected volatility | 70% | 95% | |
Expected volatility, minimum | 70% | ||
Expected volatility, maximum | 80% | ||
Risk-free interest rate, minimum | 1.50% | 0.90% | 0.40% |
Risk-free interest rate, maximum | 3.90% | 1.40% | 0.70% |
Expected term | 5 years 10 months 24 days | 6 years | 5 years 10 months 24 days |
Weighted average fair value | $ 2.32 | $ 5.64 | $ 3.06 |
Summary of Activity for Restric
Summary of Activity for Restricted Stock Awards (Details) - Restricted Stock Units (RSUs) [Member] | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Number of units outstanding, Beginning | shares | |
Weighted average grant date fair value per unit outstanding, Beginning | $ / shares | |
Number of units, granted | shares | 373,606 |
Weighted average grant date fair value per unit, granted | $ / shares | $ 2.63 |
Number of units, vested | shares | |
Weighted average grant date fair value per unit, vested | $ / shares | |
Number of units, forfeited | shares | (4,000) |
Weighted average grant date fair value per unit, forfeited | $ / shares | $ 2.63 |
Number of units outstanding, Ending | shares | 369,606 |
Weighted average grant date fair value per unit outstanding, Ending | $ / shares | $ 2.63 |
Share-Based Payment Awards (Det
Share-Based Payment Awards (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||||||||
Apr. 30, 2021 | Apr. 30, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Jan. 02, 2022 | Jan. 02, 2021 | Jan. 02, 2020 | Dec. 31, 2019 | Jan. 02, 2019 | Dec. 31, 2018 | May 31, 2017 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Common stock, shares outstanding | 25,353,119 | 24,626,004 | ||||||||||
Modification expense | $ 104 | |||||||||||
Stock-based compensation expense | 4,218 | $ 3,381 | $ 2,576 | |||||||||
Proceeds from stock option exercised | 251 | 541 | 367 | |||||||||
Employees contribution amount | 172 | 154 | 117 | |||||||||
Share-Based Payment Arrangement, Option [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Unrecognized compensation costs | $ 3,868 | |||||||||||
Weighted average period | 2 years | |||||||||||
Restricted Stock Units (RSUs) [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Unrecognized compensation costs | $ 858 | |||||||||||
Weighted average period | 3 years 6 months | |||||||||||
Stock-based compensation expense | $ 114 | |||||||||||
General and Administrative Expense [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Modification expense | 244 | |||||||||||
Stock-based compensation expense | 3,954 | 2,838 | 2,295 | |||||||||
Research and Development Expense [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Stock-based compensation expense | $ 264 | $ 543 | $ 281 | |||||||||
Common Stock [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Stock-based compensation, shares | 15,190 | |||||||||||
Stock option exercises, shares | 25,000 | 144,233 | 194,878 | |||||||||
Stock Options [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Stock option intrinsic value | $ 31 | |||||||||||
Stock option exercises, shares | 25,000 | |||||||||||
Proceeds from stock option exercised | $ 35 | |||||||||||
RSA To New Employee [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Stock-based compensation, shares | 15,190 | |||||||||||
Restricted stock vested percentage | 100% | 25% | ||||||||||
Product Consultant [Member] | Common Stock [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Stock options expiration period | 10 years | |||||||||||
Number of stock options issued to purchase common stock | 50,000 | |||||||||||
Stock options expiration period | 5 years | |||||||||||
Board of Directors [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Exercise price, minimum | $ 1.37 | |||||||||||
Exercise price, maximum | $ 8.61 | |||||||||||
Employee Stock Purchase Plan [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Number of shares available for issuance | 560,296 | |||||||||||
Stock option exercises, shares | 69,884 | 49,155 | ||||||||||
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] | ||||||||||||
Number of shares available for issuance | 239,167 | |||||||||||
Share reserve increased | 985,040 | 972,512 | 715,099 | 704,317 | ||||||||
Common stock, shares outstanding | 24,626,004 | 24,312,808 | 17,877,486 | 17,607,928 | ||||||||
Stock option exercises, shares | 25,000 | 144,233 | ||||||||||
2018 Equity Incentive Plan [Member] | January 1, 2019 and Through January 1, 2028 [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Percentage for total number of shares outstanding | 4% | |||||||||||
2018 Employee Stock Purchase Plan [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Number of shares available for issuance | 150,000 | |||||||||||
Stock-based compensation expense | $ 128 | $ 73 | $ 71 | |||||||||
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, 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 ending on or around June 10 and December 10 each year, subject to a restart feature if the Company’s stock price drops at the end of a six-month period within the twelve-month offering period | |||||||||||
Weighted average grant date fair value issued | $ 1.17 | $ 2.50 | $ 2.32 | |||||||||
Employees contribution amount | $ 234 | $ 205 | ||||||||||
Accrued liabilities for remaining employee contributions | $ 23 | $ 22 |
Computation of Basic and Dilute
Computation of Basic and Diluted Net Loss Per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Earnings Per Share [Abstract] | |||
Net loss | $ (9,021) | $ (1,955) | $ (27,970) |
Weighted average common shares outstanding (basic and diluted) | 25,145,657 | 25,207,299 | 21,010,058 |
Net loss per common share (basic and diluted) | $ (0.36) | $ (0.08) | $ (1.33) |
Basic and Diluted Net Loss pe_3
Basic and Diluted Net Loss per Common Share (Details Narrative) - shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Earnings Per Share [Abstract] | |||
Anti-dilutive securities excluded from calculation of diluted net loss per share | 5,494,153 | 4,286,687 | 3,371,489 |
Related-Party Transactions (Det
Related-Party Transactions (Details Narrative) - USD ($) | 1 Months Ended | 9 Months Ended | 12 Months Ended | |||||
Feb. 18, 2019 | Aug. 11, 2017 | May 31, 2021 | Apr. 30, 2021 | Sep. 30, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Related Party Transaction [Line Items] | ||||||||
Proceeds from sale of machinery and equipment | $ 700,000 | |||||||
Payment of research and development expense | 3,996,000 | $ 6,235,000 | $ 14,104,000 | |||||
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 | $ 1,818,000 | ||||||
Eyemax [Member] | One Milestone [Member] | Amended and Restated Agreement [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Related party transaction | 250,000 | |||||||
Eyemax [Member] | Two Milestone [Member] | Amended and Restated Agreement [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Related party transaction | $ 500,000 | |||||||
Harrow Health Inc [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Common Stock shares Owned | $ 1,982,000 | |||||||
Harrow Health Inc [Member] | Ownership [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Equity Method Investment, Ownership Percentage | 7.80% | |||||||
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% | |||||||
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 | |||||||
Chief Executive Officer [Member] | Restricted Stock [Member] | Harrow Health Inc [Member] | ||||||||
Related Party Transaction [Line Items] | ||||||||
Stock Issued During Period, Shares, Issued for Services | 25,000 |
Schedule of Lease-related Asset
Schedule of Lease-related Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Nov. 30, 2022 | Dec. 31, 2021 | Oct. 31, 2020 |
Leases | ||||
Total leased assets | $ 188 | $ 188 | $ 104 | $ 195 |
Operating lease liabilities, current | $ 75 | |||
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Accrued liabilities | |||
Operating lease liabilities, noncurrent | $ 107 | $ 15 | ||
Total operating lease liabilities | $ 182 | $ 188 | $ 195 |
Schedule of Future Lease Commit
Schedule of Future Lease Commitments (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Nov. 30, 2022 | Oct. 31, 2020 |
Leases | |||
Undiscounted lease payments | $ 201 | ||
2023 | 88 | ||
2024 | 90 | ||
2025 | 23 | ||
Less: Imputed interest | (19) | ||
Total lease liabilities | $ 182 | $ 188 | $ 195 |
Leases (Details Narrative)
Leases (Details Narrative) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
Nov. 30, 2022 | Nov. 30, 2020 | Oct. 31, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Lease renewed description | In November 2022, the Company renewed its office lease for a two-year period through March 31, 2025 | In November 2020, this laboratory lease was extended to June 2021 | In October 2020, the Company renewed its office lease for a two-year period through March 31, 2023 | |||
Rights to use of assets | $ 188 | $ 195 | $ 188 | $ 104 | ||
Operating lease liabilities | $ 188 | $ 195 | $ 182 | |||
Incremental borrowing rate | 7.80% | |||||
Estimated discount rate percentage | 5.40% | |||||
Estimated discount rate percentage | 8.60% | |||||
Lease rent expense | $ 87 | 113 | $ 139 | |||
Operating lease payments | 88 | 83 | ||||
Operating lease, right-of-use asset, amortization expense | $ 82 | 88 | 129 | |||
Operating lease, weighted average remaining lease term | 2 years 3 months | |||||
Operating lease, weighted average discount rate | 8.60% | |||||
Research and Development Expense [Member] | ||||||
Operating lease cost | $ 0 | 9 | 55 | |||
General and Administrative Expense [Member] | ||||||
Operating lease cost | $ 82 | $ 86 | $ 84 |
Schedule of Provision for Incom
Schedule of Provision for Income Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Current: | |||
Federal | |||
State | |||
Total current expense | |||
Deferred: | |||
Federal | 2,272 | 460 | 6,020 |
State | 812 | 185 | 2,151 |
Change in valuation allowance | (3,084) | (645) | (8,171) |
Total deferred expense | |||
Total provision |
Schedule of Deferred Tax Assets
Schedule of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Income Tax Disclosure [Abstract] | ||
Net operating losses | $ 17,183 | $ 15,871 |
Stock-based expenses | 3,090 | 2,135 |
Accruals and other | 1,359 | 542 |
Total deferred tax assets | 21,632 | 18,548 |
Valuation allowance | (21,632) | (18,548) |
Net deferred tax assets |
Schedule of Reconciliation of S
Schedule of Reconciliation of Statutory Federal Tax Rate (Details) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |||
Benefit at statutory rate | (21.00%) | (21.00%) | (21.00%) |
Permanent items (primarily warrants and stock compensation) | (3.30%) | (2.50%) | (0.50%) |
State tax benefit | (8.70%) | (9.50%) | (7.70%) |
Federal rate change | |||
Other items | |||
Increase in valuation allowance | 33% | 33% | 29.20% |
Income tax expense |
Income Taxes (Details Narrative
Income Taxes (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2017 | |
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | |||
Percentage for valuation reserve against deferred tax assets | 100% | 100% | |
Deferred tax assets, gross | $ 21,632 | $ 18,548 | |
Operating loss carryforwards | $ 60,281 | $ 5,652 | |
Net operating loss carryforward expiration | expire in 2029 | ||
Minimum [Member] | Ownership [Member] | |||
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | |||
Equity ownership percentage | 50% | ||
After December 31, 2017 [Member] | |||
Significant Change in Unrecognized Tax Benefits is Reasonably Possible [Line Items] | |||
Operating loss carryforwards | $ 54,629 |
Employee Savings Plan (Details
Employee Savings Plan (Details Narrative) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Retirement Benefits [Abstract] | |||
Percentage for tax deferred investment | 100% | ||
Percentage for matching contribution | 4% | ||
Employee saving plan for matching contribution | $ 172 | $ 154 | $ 117 |
Commitments and Contingencies (
Commitments and Contingencies (Details Narrative) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||||||||||
Sep. 13, 2022 | Oct. 28, 2021 | Jun. 15, 2021 | Mar. 27, 2020 | Jun. 12, 2019 | Jan. 23, 2019 | Mar. 31, 2022 | Oct. 31, 2020 | Mar. 31, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Mar. 26, 2020 | |
Product Liability Contingency [Line Items] | |||||||||||||
Revenue recognized | $ 22,000 | ||||||||||||
Additional milestone revenues | 20,000 | ||||||||||||
Research and development expense | 3,996 | $ 6,235 | $ 14,104 | ||||||||||
Stock issued during period, value, new issues | 28,782 | ||||||||||||
Payments for licensing rights | $ 2,000 | $ 3,250 | |||||||||||
Percentage of net profits payments to third party from sale of product | 65% | 50% | |||||||||||
Revenues | 21,251 | 21,832 | 39 | ||||||||||
Cost of goods sold | 6,933 | 2,827 | 436 | ||||||||||
Payments for commercil milestones | $ 1,000 | ||||||||||||
Dr Reddys [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Held in escrow | 250 | ||||||||||||
Licensing And Supply Agreement [Member] | Licensor [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Research and development expense | $ 650 | ||||||||||||
Licensing And Supply Agreement [Member] | Licensor [Member] | Product Sales [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Research and development expense | 500 | ||||||||||||
Licensing And Supply Agreement [Member] | Licensor [Member] | Calendar Year [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Research and development expense | $ 10,000 | ||||||||||||
Tulex Pharmaceuticals Inc [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Payment of filing fee | $ 1,438 | ||||||||||||
Milestone payment amount | 5,000 | ||||||||||||
Aucta pharmaceuticals inc [Member] | ET-105 License Agreement [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Payments for Royalties | $ 2,000 | ||||||||||||
Aucta pharmaceuticals inc [Member] | ET-105 License Agreement [Member] | Maximum [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Milestone payment amount | 3,000 | ||||||||||||
Aucta pharmaceuticals inc [Member] | ET-105 License Agreement [Member] | Upon FDA approval [Member[ | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Payments for Royalties | 2,450 | ||||||||||||
Aucta pharmaceuticals inc [Member] | ET-105 License Agreement [Member] | Upon Issuance of Orange-book Listed Patent [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Payments for Royalties | 1,000 | ||||||||||||
Aucta pharmaceuticals inc [Member] | ET-105 License Agreement [Member] | Upon FDA Acceptance of Product Filing [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Payments for Royalties | $ 1,500 | ||||||||||||
Aucta pharmaceuticals inc [Member] | ET-105 License Agreement [Member] | Sales Exceed $10 Million [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
[custom:MilestonePaymentDescription] | 1,000 when net sales exceed $10 million in a calendar year | ||||||||||||
Aucta pharmaceuticals inc [Member] | ET-105 License Agreement [Member] | Sales Exceed $20 Million [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
[custom:MilestonePaymentDescription] | 2,000 when net sales exceed $20 million in a calendar year | ||||||||||||
Diurnal Limited [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Proceeds from sales of common stock, net of offering costs, shares | 379,474 | ||||||||||||
Stock issued during period, value, new issues | $ 1,264 | ||||||||||||
Payment for obtaining product orphan drug | $ 2,500 | ||||||||||||
Diurnal Limited [Member] | Exclusive License and Supply Agreement [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Cash paid for licensing milestone fee | $ 3,500 | ||||||||||||
Proceeds from sales of common stock, net of offering costs, shares | 379,474 | ||||||||||||
Stock issued during period, value, new issues | $ 1,264 | ||||||||||||
Shares issued, price per share | $ 3.33 | ||||||||||||
Aggregate value of licensing milestone amount | 4,764 | ||||||||||||
Crossject S.A. [Member] | Distribution and Promotion License Agreement [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Research and development expense | $ 500 | $ 500 | |||||||||||
Sale of stock, percentage | 10% | ||||||||||||
Crossject S.A. [Member] | Distribution and Promotion License Agreement [Member] | Maximum [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Cash paid for licensing milestone fee | $ 6,000 | ||||||||||||
Crossject S.A. [Member] | Distribution and Promotion License Agreement [Member] | Upon FDA Acceptance of Product Filing [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Research and development expense | 3,500 | ||||||||||||
Sintetica [Member] | Dr Reddys [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Cost of goods sold | 812 | ||||||||||||
Licensing Revenue [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Revenue recognized | 5,000 | ||||||||||||
Revenues | 10,000 | 19,000 | |||||||||||
Cost of goods sold | 1,640 | $ 1,500 | |||||||||||
Licensing Revenue [Member] | Dr Reddys [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Additional payment received | $ 42,500 | ||||||||||||
Additional payment rate | 10% | ||||||||||||
Licensing Revenues [Member] | Dr Reddys [Member] | |||||||||||||
Product Liability Contingency [Line Items] | |||||||||||||
Revenues | $ 5,000 |