Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 27, 2024 | Jun. 30, 2023 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Transition Report | false | ||
Entity File Number | 001-36464 | ||
Entity Registrant Name | AGILE THERAPEUTICS INC | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 23-2936302 | ||
Entity Address, Address Line One | 500 College Road East, Suite 310 | ||
Entity Address, City or Town | Princeton | ||
Entity Address, State or Province | NJ | ||
Entity Address, Postal Zip Code | 08540 | ||
City Area Code | 609 | ||
Local Phone Number | 683-1880 | ||
Title of 12(g) Security | Common Stock, par value $0.0001 per share | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 4.8 | ||
Entity Common Stock, Shares Outstanding | 6,856,229 | ||
Entity Central Index Key | 0001261249 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Firm ID | 42 | ||
Auditor Location | Iselin, New Jersey |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 2,557 | $ 5,246 |
Accounts receivable, net | 3,392 | 3,377 |
Inventory, net | 2,738 | 1,332 |
Prepaid expenses and other current assets | 843 | 1,403 |
Total current assets | 9,530 | 11,358 |
Property and equipment, net | 75 | 177 |
Right of use asset | 412 | 695 |
Other non-current assets | 238 | 2,012 |
Total assets | 10,255 | 14,242 |
Current liabilities: | ||
Long-term debt, current portion | 1,515 | 1,426 |
Notes payable, current portion | 191 | |
Accounts payable | 9,574 | 7,734 |
Accrued expenses | 9,131 | 3,908 |
Lease liability, current portion | 366 | 319 |
Total current liabilities | 20,777 | 13,387 |
Lease liabilities, long-term | 100 | 466 |
Warrant liability | 5,696 | 5,934 |
Total liabilities | 26,573 | 19,787 |
Commitments and contingencies (Note 12) | ||
Stockholders' deficit | ||
Preferred stock, $0.0001 par value, 10,000,000 shares authorized, 4,850 issued and no shares outstanding at December 31, 2023 and no shares issued and outstanding at December 31, 2022 | ||
Common stock, $0.0001 par value, 300,000,000 shares authorized, 2,963,657 and 859,402 issued and outstanding at December 31, 2023 and December 31, 2022, respectively | 4 | |
Additional paid-in capital | 406,846 | 403,157 |
Accumulated deficit | (423,168) | (408,702) |
Total stockholders' deficit | (16,318) | (5,545) |
Total liabilities and stockholders' deficit | $ 10,255 | $ 14,242 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Balance Sheets | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, issued (in shares) | 4,850 | 0 |
Preferred stock, outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, authorized (in shares) | 300,000,000 | 300,000,000 |
Common stock, issued (in shares) | 2,963,657 | 859,402 |
Common stock, outstanding (in shares) | 2,963,657 | 859,402 |
Statements of Operations and Co
Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Statements of Operations and Comprehensive Loss | |||
Revenues, net | $ 19,593 | $ 10,884 | $ 4,101 |
Cost of product revenues | 8,978 | 6,836 | 10,718 |
Gross profit | 10,615 | 4,048 | (6,617) |
Operating expenses: | |||
Research and development | 2,225 | 3,253 | 6,246 |
Selling and marketing | 17,769 | 30,369 | 43,444 |
General and administrative | 10,505 | 11,860 | 14,698 |
Loss on disposition of assets | 11,122 | ||
Total operating expenses | 30,499 | 56,604 | 64,388 |
Loss from operations | (19,884) | (52,556) | (71,005) |
Other income (expense) | |||
Interest income | 78 | 80 | 25 |
Interest expense | (1,419) | (3,131) | (3,914) |
Unrealized gain on warrant liability | 6,760 | 25,520 | 3,827 |
Total other income (expense), net | 5,419 | 22,469 | (62) |
Loss before benefit from income taxes | (14,465) | (30,087) | (71,067) |
Benefit from income taxes | 4,675 | ||
Net loss | $ (14,465) | $ (25,412) | $ (71,067) |
Net loss per share (basic) (in dollars per share) | $ (6.71) | $ (58.79) | $ (1,464.20) |
Net loss per share (diluted) (in dollars per share) | $ (6.71) | $ (58.79) | $ (1,464.20) |
Weighted-average common shares (basic) (in shares) | 2,156,726 | 432,219 | 48,536 |
Weighted-average common shares (diluted) (in shares) | 2,156,726 | 432,219 | 48,536 |
Comprehensive loss: | |||
Net loss | $ (14,465) | $ (25,412) | $ (71,067) |
Other comprehensive income: | |||
Unrealized (loss) on marketable securities | (3) | ||
Comprehensive loss | $ (14,465) | $ (25,412) | $ (71,070) |
Statements of Changes in Stockh
Statements of Changes in Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Preferred Stock Series A Convertible Preferred Stock | Preferred Stock Series B Convertible Preferred Stock | Preferred Stock Series A and B Convertible Preferred Stock | Common stock Public offering | Common stock At-the-market sales | Common stock Series A Convertible Preferred Stock | Common stock Series B Convertible Preferred Stock | Common stock | Additional Paid-in Capital. Public offering | Additional Paid-in Capital. At-the-market sales | Additional Paid-in Capital. | Accumulated Other Comprehensive Income | Accumulated Deficit | Public offering | At-the-market sales | Total |
Balance at Dec. 31, 2020 | $ 361,548 | $ 3 | $ (312,223) | $ 49,328 | ||||||||||||
Balance (in shares) at Dec. 31, 2020 | 43,782 | |||||||||||||||
Increase (decrease) in stockholders' equity | ||||||||||||||||
Share-based compensation - stock options and RSUs | 3,338 | 3,338 | ||||||||||||||
Issuance of common stock | $ 11,898 | $ 9,266 | $ 11,898 | $ 9,266 | ||||||||||||
Issuance of common stock (in shares) | 13,333 | 3,458 | ||||||||||||||
Issuance of common stock upon exercise of options | 75 | 75 | ||||||||||||||
Issuance of common stock upon exercise of options (in shares) | 63 | |||||||||||||||
Vesting of RSUs (in shares) | 62 | |||||||||||||||
Warrants issued in connection with long-term debt | 1,080 | 1,080 | ||||||||||||||
Unrealized net gain on marketable securities | $ (3) | (3) | ||||||||||||||
Net Income (Loss) | (71,067) | (71,067) | ||||||||||||||
Balance at Dec. 31, 2021 | 387,205 | (383,290) | 3,915 | |||||||||||||
Balance (in shares) at Dec. 31, 2021 | 60,698 | |||||||||||||||
Increase (decrease) in stockholders' equity | ||||||||||||||||
Share-based compensation - stock options and RSUs | 2,492 | 2,492 | ||||||||||||||
Issuance of common stock | $ 3 | $ 1 | 13,456 | $ 3 | 13,457 | |||||||||||
Issuance of common stock (in shares) | 533,333 | 253,115 | ||||||||||||||
Conversion of convertible preferred stock (in shares) | (2,425) | (2,425) | 4,850 | 6,063 | 6,063 | |||||||||||
Vesting of RSUs (in shares) | 130 | |||||||||||||||
Net Income (Loss) | (25,412) | (25,412) | ||||||||||||||
Balance at Dec. 31, 2022 | $ 4 | 403,153 | (408,702) | (5,545) | ||||||||||||
Balance (in shares) at Dec. 31, 2022 | 859,402 | |||||||||||||||
Increase (decrease) in stockholders' equity | ||||||||||||||||
Share-based compensation - stock options and RSUs | 1,981 | 1,981 | ||||||||||||||
Fractional shares retired as a result of reverse split | (13) | (13) | ||||||||||||||
Issuance of common stock | $ 1,725 | $ 1,725 | ||||||||||||||
Issuance of common stock (in shares) | 95,000 | 207,883 | ||||||||||||||
Exercise of pre-funded warrants (in shares) | 1,801,286 | |||||||||||||||
Vesting of RSUs (in shares) | 86 | |||||||||||||||
Net Income (Loss) | (14,465) | (14,465) | ||||||||||||||
Balance at Dec. 31, 2023 | $ 4 | $ 406,846 | $ (423,168) | $ (16,318) | ||||||||||||
Balance (in shares) at Dec. 31, 2023 | 2,963,657 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities: | |||
Net loss | $ (14,465) | $ (25,412) | $ (71,067) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Noncash inventory reserve | 801 | 397 | 5,323 |
Depreciation | 102 | 1,280 | 2,064 |
Amortization | 284 | 254 | 159 |
Loss on disposition of assets | 11,122 | ||
Noncash stock-based compensation | 1,981 | 2,493 | 3,338 |
Noncash amortization of deferred financing costs | 1,063 | 1,969 | 1,661 |
Unrealized gain on warrants | (6,760) | (25,520) | (3,827) |
Changes in operating assets and liabilities: | |||
Accounts receivable | (15) | (1,844) | (668) |
Inventory | (2,207) | (763) | (6,289) |
Prepaid expenses and other assets | 2,270 | 880 | (967) |
Accounts payable and accrued expenses | 7,688 | (628) | 5,202 |
Lease liability | (319) | (175) | (131) |
Net cash used in operating activities | (9,577) | (35,947) | (65,202) |
Cash flows from investing activities: | |||
Sales and maturities of marketable securities | 39,729 | ||
Acquisition of property and equipment | (133) | (269) | |
Net cash (used in) provided by investing activities | (133) | 39,460 | |
Cash flows from financing activities: | |||
Proceeds from issuance of common stock in public offering, net of offering costs | 6,510 | 21,936 | 21,081 |
Repayments of long-term debt | (975) | (17,375) | |
Proceeds from exercise of stock options | 75 | ||
Repayments of note payable | (372) | ||
Net cash provided by financing activities | 6,888 | 22,183 | 30,422 |
Net (decrease) increase in cash and cash equivalents | (2,689) | (13,897) | 4,680 |
Cash and cash equivalents, beginning of period | 5,246 | 19,143 | 14,463 |
Cash and cash equivalents, end of period | 2,557 | 5,246 | 19,143 |
Supplemental disclosure of noncash financing activities | |||
Warrants issued in connection with long-term debt | 1,080 | ||
Operating right-of-use assets obtained in exchange for new operating lease liabilities | 969 | ||
Supplemental cash flow information | |||
Interest paid | 356 | 1,162 | 2,383 |
Public offering | |||
Cash flows from financing activities: | |||
Proceeds from issuance of preferred stock in registered direct offering, net of offering costs | 4,128 | ||
At-the-market sales | |||
Cash flows from financing activities: | |||
Proceeds from At-the-Market sales of common stock, net of offering costs | $ 1,725 | $ 13,494 | $ 9,266 |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2023 | |
Organization and Description of Business | |
Organization and Description of Business | 1. Organization and Description of Business Nature of Operations Agile Therapeutics, Inc. (“Agile” or the “Company”) was incorporated in Delaware on December 22, 1997. Agile is a women’s healthcare company dedicated to fulfilling the unmet health needs of today’s women. The Company’s activities since inception have consisted principally of raising capital, performing research and development, including development of the Company’s lead product, Twirla ® The Company’s sole approved product, Twirla, is a once-weekly prescription contraceptive patch that received approval from the U.S. Food and Drug Administration, or FDA, in February 2020 and was commercially launched in early December 2020. Substantially all of the Company’s resources are currently dedicated to commercializing Twirla in the United States. The Company has generated minimal product revenue to date and is subject to a number of risks similar to those of other early stage commercial companies, including, but not limited to, dependence on key individuals, the difficulties and uncertainties inherent in the development of commercially usable products, market acceptance of products, protection of proprietary technology, the need to obtain additional capital necessary to fund the development of its products, reliance on a consistent supply chain both for Twirla and in general, macroeconomic factors such as inflation, competition from larger companies, and compliance with FDA and other government regulations. If the Company does not continue to successfully commercialize Twirla, it will be unable to generate recurring product revenue or achieve profitability. The Company has incurred operating losses and negative cash flows from operating activities each year since inception. As of December 31, 2023, the Company had an accumulated deficit of approximately million. The Company expects to continue to incur significant operating expenses for the foreseeable future in connection with its ongoing activities, as the Company: ● maintains a sales and marketing infrastructure and contract manufacturing arrangement to support the continued commercialization of Twirla in the United States; ● continues to commercialize Twirla and seek increased uptake of Twirla in the United States; ● continues to evaluate additional line extensions for Twirla and initiates development of potential product candidates in addition to Twirla; ● maintains, leverages, and expands the Company’s intellectual property portfolio; and ● maintains operational, financial, and management information systems and personnel, including personnel to support the Company’s product development and future commercialization efforts. The Company has financed its operations to date primarily through the issuance and sale of its common stock in both public and private offerings (see Note 9), private placements of its convertible preferred stock, venture loans, and non-dilutive grant funding. Going Concern As of December 31, 2023, the Company had cash and cash equivalents of $2.5 million and a $11.2 million working capital deficit. The Company’s current liquidity is sufficient to fund operations into April 2024. The Company closely monitors its cash and cash equivalents and will need to raise additional funds to meet its projected operating requirements, including the continued commercialization of Twirla, and exploring the advancement of its existing pipeline and its possible expansion through business development activities. The Company has generated losses since inception, used substantial cash in operations, has a working capital deficit as of December 31, 2023, and anticipates it will continue to incur net losses for the foreseeable future. The Company’s future success depends on its ability to obtain additional capital and/or implement various strategic alternatives, and there can be no assurance that any financing can be realized by the Company, or if realized, what the terms of any such financing may be, or that any amount that the Company is able to raise will be adequate. Based upon the foregoing, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern through the 12 months following the date on which this Annual Report on Form 10-K is filed. The Company continues to analyze various alternatives, including refinancing alternatives, asset sales and mergers and acquisitions. The Company’s future success depends on its ability to raise additional capital as discussed above. The Company cannot be certain that these initiatives, or raising additional capital, whether through selling additional debt or equity securities or obtaining a line of credit or other loan, will be available to it or, if available, will be on terms acceptable to the Company. If the Company issues additional securities to raise funds, these securities may have rights, preferences, or privileges senior to those of its common stock, and the Company’s current stockholders will experience dilution. If the Company is unable to obtain funds when needed or on acceptable terms, the Company then may be unable to continue the commercialization of Twirla, and may also be required to cut operating costs, and forego future development and other opportunities. The audited financial statements as of December 31, 2023 have been prepared under the assumption that the Company will continue as a going concern for the next 12 months. The Company’s ability to continue as a going concern is dependent upon its uncertain ability to obtain additional capital, reduce expenditures and/or execute its business plan and successfully commercialize Twirla. The audited financial statements as of December 31, 2023 do not include any adjustments that might result from the outcome of this uncertainty. If the Company is unable to continue as a going concern, it may have to liquidate its assets and may receive less than the value at which those assets are carried on the financial statements. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Polices Basis of Presentation The accompanying financial statements have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) and include all adjustments necessary for the fair presentation of the Company's financial position for the periods presented. Use of Estimates The preparation of the Company’s financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates and judgments on historical experience and various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s balance sheets and the amounts of revenue and expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, revenue recognition, inventory reserves, the accounting for common stock warrants, stock-based compensation, and accounting for research and development costs. As future events and their effects cannot be determined with precision, actual results could differ significantly from these estimates. Risks and Uncertainties While Twirla has been approved by the FDA, other potential product candidates developed by the Company will require approval from the FDA prior to commercial sales. There can be no assurance that the Company’s other product candidates will receive the required approval. If the Company is denied approval or such approval is delayed or is unable to obtain the necessary financing to complete development and approval, there could be a material adverse impact on the Company’s financial condition and results of operations. Cash and Cash Equivalents The Company considers all highly-liquid investments with an original maturity of three months or less when purchased to be cash equivalents. All cash and cash equivalents are held in United States financial institutions. Cash and cash equivalents include money market funds that invest primarily in commercial paper and U.S. government and U.S. government agency obligations. The Company maintains balances with financial institutions in excess of the Federal Deposit Insurance Corporation limit. Accounts Receivable and Allowances Accounts receivable are amounts owed to the Company by its customers for product that has been delivered. The accounts receivable are recorded at the invoice amount, less prompt pay and other discounts, chargebacks, and an allowance for credit losses, if any. The allowance for credit losses represents the Company’s estimate of losses over the life of the receivables. The Company evaluates forward-looking economic factors and uses professional judgment to determine the allowance for credit losses. The credit loss reserves are reviewed and adjusted periodically. Credit loss reserves were not material as of December 31, 2023 and 2022, respectively. Accounts receivable are aged based on the contractual payment terms. When the collectability of an invoice is no longer probable, the Company will create a reserve for that specific receivable. If a receivable is determined to be uncollectible, it is charged against the general credit loss reserve or the reserve for the specific receivable, if one exists. Fair Value of Financial Instruments In accordance with Accounting Standards Codification (“ASC”) 825, Financial Instruments Other financial instruments, including accounts receivable, accounts payable and accrued liabilities, are carried at cost which approximates fair value given their short-term nature. Inventory Inventory is valued utilizing the weighted average costing method. The Company records an inventory reserve for losses associated with dated, expired, excess or obsolete items. This reserve is based on management’s current knowledge with respect to inventory levels, planned production and sales volume assumptions. As of December 31, 2023 and 2022 inventory reserves approximated Property and Equipment Property and equipment, consisting of office equipment, computer equipment and manufacturing equipment, is stated at cost, less accumulated depreciation. Depreciation is computed using the straight- line method over the estimated useful lives of the assets. Expenditures incurred after the fixed assets have been put into operation, such as repairs and maintenance, are charged to earnings in the period in which costs are incurred. Improvements and additions are capitalized in accordance with Company policy. In the third quarter of 2022, the Company transferred manufacturing equipment with a book value of $11.1 million to Corium in exchange for relief from minimum material purchase requirements. The Company recorded a loss of Long-Lived Assets In accordance with ASC 360, Property, Plant and Equipment Research and Development Expense Research and development costs are expensed as incurred. Research and development expense consists primarily of costs related to personnel, including salaries and other personnel-related expenses, expenses related to manufacturing, clinical trial expenses, consulting fees and support services used in drug development. All research and development costs are charged to operations as incurred in accordance with ASC 730, Research and Development In certain circumstances, the Company is required to make advance payments to vendors for goods or services that will be received in the future for use in research and development activities. In such circumstances, the advance payments are deferred and are expensed when the activity has been performed or when the goods have been received. Advertising Costs The Company has elected to expense advertising costs when incurred. Advertising costs totaled Deferred Financing Costs Costs directly attributable to the Company’s term loan (see Note 8) are deferred and reported as a reduction of the related term loan. These costs represent legal fees and other costs related to the term loan and are being amortized utilizing the straight-line method over the term of the loan. Amortization of deferred financing costs charged to interest expense was approximately $185,000, $342,000 and $277,000 for the years ended December 31, 2023, 2022 and 2021, respectively. Concentrations of Credit Risk Financial instruments which potentially subject the Company to credit risk consist principally of cash, cash equivalents, and accounts receivable. The Company invests its cash and cash equivalents in interest-bearing accounts in United States financial institutions, the balances of which exceed federally insured limits. The Company mitigates credit risk by limiting the investment type and maturity to securities that preserve capital, maintain liquidity, and have a high credit quality. The Company has not recognized any losses from credit risks on such accounts. The Company has Major customers of the Company are defined as those constituting greater than 10% of its total revenue. In 2023, the Company had sales to five customers that individually accounted for more than 10% of total revenue. These customers had sales of $4.7 million, $3.8 million, $3.7 million, $3.5 million and $2.8 million, respectively, which represented 94% of the Company’s total revenue for 2023. Accounts receivable related to these five customers comprised 6%, 30%, 30%, 29% and 0% of the Company’s total accounts receivable, respectively, as of December 31, 2023. In 2022, the Company had sales to $2.9 million, $2.7 million, $2.6 million and $1.2 million, respectively, which represented 86% of the Company’s total revenue for 2022. Revenue Recognition The Company recognizes revenue from the sale of its product, Twirla, in accordance with ASC 606, Revenue from Contracts with Customers In accordance with ASC 606, the Company recognizes revenue at the point in time when its performance obligation is satisfied by transferring control of the promised goods or services to a customer. In accordance with the Company’s contracts with customers, control of the product is transferred upon the conveyance of title, which occurs when the product is sold to and received by a customer. The Company’s customers are located in the United States and consist primarily of wholesale distributors. Accounts receivable due to the Company from contracts with its customers are stated separately in the balance sheet, net of various allowances as described later in this section and in the Accounts Receivable and Allowance policy. The amount of revenue recognized by the Company is equal to the amount of consideration that is expected to be received from the sale of product to its customers. Revenue is only recognized when it is probable that a significant reversal will not occur in future periods. To determine whether a significant reversal will occur in future periods, the Company assesses both the likelihood and magnitude of any such potential reversal of revenue. Twirla is sold to customers at the wholesale acquisition cost (“WAC”). However, the Company records product revenue, net of reserves for applicable variable consideration. These types of variable consideration items reduce revenue and include the following: ● Distribution services fees; ● Prompt pay and other discounts; ● Product returns; ● Chargebacks; ● Rebates; and ● Co-payment assistance. An estimate for each variable consideration item is made and is recorded in conjunction with the revenue being recognized. Generally, if the estimated amount is payable to a customer, it is recorded as a reduction to accounts receivable. If the estimated amount is payable to an entity other than a customer, it is recorded as a current liability. An estimated amount of variable consideration may differ from the actual amount. At each balance sheet date, these provisions are analyzed, and adjustments are made if necessary. Any adjustments made to these provisions would affect net product revenue and earnings in the current period. In accordance with ASC 606, the Company must make judgments to determine the estimate for certain variable consideration. For example, the Company must estimate the percentage of end-users that will obtain the product through public insurance such as Medicaid or through private commercial insurance. To determine these estimates, the Company had relied on quantitative and qualitative data from various internal and external sources to estimate its variable consideration. The specific considerations that the Company uses in estimating these amounts related to variable considerations are as follows: Distribution services fees – The Company pays distribution service fees primarily to its wholesale distributors. These fees are a contractually fixed percentage of WAC and are calculated at the time of sale based on the purchase amount. The Company records these fees as contra accounts receivable on the balance sheet. Prompt pay and other discount The Company may also give other discounts to its customers to incentivize purchases and promote customer loyalty. The terms of such discounts may vary by customer. These discounts reduce gross product revenue at the time the revenue is recorded. Product returns Chargebacks Rebates Co-payment assistance Customer credits, Rebates and co-pay discounts and allowances assistance Product returns (contra accounts receivable) (accrued expenses) (accrued expenses) Total Balance as of December 31, 2021 $ 371 $ 528 $ 141 $ 1,040 Allowances for current period sales 5,891 4,035 399 10,325 Payments and credits (3,268) (2,574) (197) (6,039) Balance as of December 31, 2022 2,994 1,989 343 5,326 Allowances for current period sales 18,385 8,192 2,964 29,541 Payments and credits (16,665) (5,564) (1,432) (23,661) Balance as of December 31, 2023 $ 4,714 $ 4,617 $ 1,875 $ 11,206 Warrants The Company accounts for its warrants to purchase common stock in accordance with ASC 480, Distinguishing Liabilities from Equity . In connection with entering into a senior secured term loan facility in February 2020 (the “Perceptive Credit Agreement”), the Company issued warrants to purchase shares of its common stock to the lender, Perceptive Credit Holdings III, L.P. (“Perceptive”). In connection with an amendment to that facility in February 2021, the Company issued warrants to purchase In connection with an underwritten public offering completed in October 2021, the Company issued warrants to purchase 6,660 shares of its common stock. These warrants are classified as liabilities, were measured at fair value upon issuance, with subsequent changes in fair value reported in the Statements of Operations and Comprehensive Loss each reporting period. This offering also triggered an adjustment to the exercise price of the Perceptive Warrants, which resulted in a reduction of the strike price for these warrants. This reduction resulted in an immaterial increase to additional paid-in-capital. See Notes 8 and 9 for additional information. In connection with a registered direct offering completed in March 2022, the Company issued warrants to purchase shares of its common stock. These warrants are classified as liabilities, were measured at fair value upon issuance, with subsequent changes in fair value reported in the Statement of Operations and Comprehensive Loss each reporting period. This offering also triggered an adjustment to the exercise price of the Perceptive Warrants, which resulted in a reduction of the strike price for these warrants. This reduction resulted in an immaterial increase to additional paid-in-capital. See Notes 8 and 9 for additional information. In connection with a letter agreement and waiver entered into with an investor in April 2022, the Company issued warrants to purchase shares of common stock. These warrants are classified as liabilities, were measured at fair value upon issuance, with subsequent changes in fair value reported in the Statement of Operations and Comprehensive Loss each reporting period. See Note 9 for additional information. In connection with a public offering completed in July 2022, the Company issued warrants to purchase In connection with a public offering completed in May 2023, the Company issued warrants to purchase On December 3, 2023, the Company entered into a Warrant Amendment and Additional Issuance Agreement (“Warrant Amendment and Additional Issuance Agreement”) relating to the amendment of warrants to purchase shares of common stock that were issued in transactions on March 14, 2022, April 25, 2022, and May 25, 2023 (collectively, the “Warrants”). Collectively, the Warrants represent the right to purchase approximately Income Taxes The Company accounts for deferred taxes using the asset and liability method as specified by ASC 740, Income Taxes The Company has adopted the authoritative guidance on accounting for and disclosure of uncertainty in tax positions, which prescribes a comprehensive model for the financial statement recognition, measurement, presentation, and disclosure of uncertain tax positions taken or expected to be taken in income tax returns. The Company has no uncertain tax positions as of December 31, 2023 that qualify for either recognition or disclosure in the financial statements under this guidance. Stock-Based Compensation The Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation . The Company grants stock options for a fixed number of shares to employees and non-employees with an exercise price equal to the fair value of the shares at grant date. Compensation cost is recognized for all share-based payments granted and is based on the grant-date fair value estimated using the weighted-average assumption of the Black-Scholes option pricing model based on key assumptions such as stock price, expected volatility and expected term. The Company elects to account for forfeitures when they occur. The equity instrument is not considered to be issued until the instrument vests. As a result, compensation cost is recognized over the requisite service period with an offsetting credit to additional paid-in capital. The Company also awards restricted stock units (“RSUs”) to employees and its board of directors. RSUs are generally subject to forfeiture if employment terminates prior to the completion of the vesting restrictions. The Company expenses the cost of the RSUs, which is determined to be the fair market value of the shares of common stock underlying the RSUs at the date of grant, ratably over the period during which the vesting restrictions lapse. Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating and reporting Net Loss Per Share Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding plus the effect of dilutive potential common shares outstanding during the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, common stock warrants, unvested RSUs and stock options are considered to be potentially dilutive securities but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented. The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share for the years ended December 31, 2023, 2022 and 2021, respectively, because to do so would be anti-dilutive (in common equivalent shares): Year Ended December 31, 2023 2022 2021 Common stock warrants 5,589,637 1,130,025 7,592 Unvested restricted stock units 173,517 129 167 Common stock options 43,043 7,956 5,183 Total 5,806,197 1,138,111 12,941 Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (the “FASB”) or other standard setting bodies that are adopted by the Company as of the specified effective date. The Company did not adopt any new accounting pronouncements during the year ended December 31, 2023 that had a material effect on its financial statements. In November 2023, the FASB issued Accounting Standards Update (“ASU”) No. 2023-07, Segment Reporting (Topic 280) (“ASU 2023-07”). The guidance in ASU 2023-07 expands prior reportable segment disclosure requirements by requiring entities to disclose significant segment expenses that are regularly provided to the Chief Operating Decision Maker (“CODM”) and details of how the CODM uses financial reporting to assess their segment’s performance. The guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2023, with early adoption permitted. The Company is currently evaluating the impact that the adoption of ASU 2023-07 may have on its financial statements. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”). The guidance in ASU 2023-09 improves the transparency of income tax disclosures by greater disaggregation of information in the rate reconciliation and income taxes paid disaggregated by jurisdiction. The standard is effective for public companies for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact that the adoption of ASU 2023-09 may have on its financial statements. Management does not believe that any other recently issued, but not yet effective accounting pronouncements, if adopted, would have a material impact on the accompanying financial statements. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Measurements | |
Fair Value Measurements | 3. Fair Value Measurements ASC 820, Fair Value Measurements and Disclosures Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. Assets and liabilities that are measured at fair value are reported using a three-level fair value hierarchy that prioritizes the inputs used to measure fair value. This hierarchy maximizes the use of observable inputs and minimizes the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows: ● Level 1 — Quoted prices in active markets for identical assets or liabilities. The Company’s Level 1 assets consist of cash and cash equivalents. The Company has no Level 1 liabilities. ● Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted market prices for similar assets or liabilities in active markets or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets and liabilities. The Company has no Level 2 assets or liabilities. ● Level 3 — Unobservable inputs that are supported by little or no market data and which require internal development of assumptions about how market participants price the fair value of the assets or liabilities. The Company has no Level 3 assets. Level 3 liabilities consist of warrant liability. The following tables set forth the Company’s financial instruments measured at fair value by level within the fair value hierarchy as of December 31, 2023 and 2022: Level 1 Level 2 Level 3 December 31, 2023 Assets: Cash and cash equivalents $ 2,557 $ — $ — Total assets at fair value $ 2,557 $ — $ — Liabilities: Warrant Liability $ — $ — $ 5,696 Total assets at fair value $ — $ — $ 5,696 Level 1 Level 2 Level 3 December 31, 2022 Assets: Cash and cash equivalents $ 5,246 $ — $ — Total assets at fair value $ 5,246 $ — $ — Liabilities: Warrant Liability $ — $ — $ 5,934 Total assets at fair value $ — $ — $ 5,934 The significant assumptions used in preparing the option pricing model for valuing the Company’s warrants as of December 31, 2023 include (i) volatility 101.5% - 126.0%, (ii) risk-free interest rate 3.8% - 4.0%, (iii) strike price for the common warrants $3.69 and $1,700.00, (iv) fair value of common stock $1.95, and (v) expected life 2.8 – 4.4 years. The significant assumptions used in preparing the option pricing model for valuing the Company’s warrants as of December 31, 2022 include (i) volatility The following is a roll forward of the fair value of Level 3 warrants: Beginning balance at December 31, 2022 $ 5,934 Warrants issued 12,537 Change in fair value (12,775) Ending Balance December 31, 2023 $ 5,696 There were no transfers between Level 1, 2 or 3 during 2023 or 2022. |
Prepaid Expenses
Prepaid Expenses | 12 Months Ended |
Dec. 31, 2023 | |
Prepaid Expenses | |
Prepaid Expenses | 4. Prepaid Expenses Prepaid expenses consist of the following: December 31, 2023 2022 Prepaid insurance $ 441 $ 628 Other 402 775 Total prepaid expenses and other current assets $ 843 $ 1,403 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2023 | |
Property and Equipment | |
Property and Equipment | 5. Property and Equipment Property and equipment, consisting of manufacturing, office and computer equipment, is stated at cost, less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful lives of the assets. Property and equipment consist of the following: December 31, Estimated 2023 2022 Life Office equipment $ 132 $ 132 5 years Computer equipment 121 121 3 Years Manufacturing equipment — — 7 years 253 253 Less: accumulated depreciation (178) (76) Property and equipment $ 75 $ 177 In accordance with Amendment No. 1 to the Corium Agreement (the “Amendment”), the Company transferred all of its manufacturing equipment to Corium during the third quarter of 2022. |
Accrued Liabilities
Accrued Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Accrued Liabilities | |
Accrued Liabilities | 6. Accrued Liabilities Accrued liabilities consist of the following: December 31, 2023 2022 Gross to net accruals $ 6,492 $ 2,332 Accrued compensation 832 833 Accrued professional fees and other 1,807 743 Total accrued liabilities $ 9,131 $ 3,908 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2023 | |
Leases | |
Leases | 7. Leases The Company has no finance leases and one operating lease for its corporate headquarters in Princeton, NJ. The current lease commenced on December 1, 2021 and terminates on March 31, 2025. The lease provides the Company with an option to extend the lease for an additional five years. Under the terms of the lease, the Company pays base annual rent subject to a fixed dollar amount increase each year, a fixed monthly charge for electricity, and other normal operating expenses such as taxes, repairs, and maintenance. The Company evaluates renewal options at lease inception and on an ongoing basis and includes renewal options that it is reasonably certain to exercise in its expected lease terms when classifying leases and measuring lease liabilities. The lease does not require variable lease payments, residual value guarantees, or restrictive covenants. The lease does not provide an implicit rate; therefore, the Company used its incremental borrowing rate as the discount rate when measuring the operating lease liability. The incremental borrowing rate represents an estimate of the interest rate the Company would incur at lease commencement to borrow an amount equal to the lease payments on a collateralized basis over the term of the lease. Operating lease expense was for the years ended December 31, 2023, 2022 and 2021, respectively. Operating cash flows used for operating leases during the years ended December 31, 2023, 2022 and 2021 were respectively. As of December 31, 2023, the weighted-average remaining lease term was Future minimum lease payments under non-cancellable leases as of December 31, 2023 were as follows: 2024 $ 397 2025 101 Total $ 498 Less: Interest (32) Present value of lease liability $ 466 |
Credit Agreement and Guaranty
Credit Agreement and Guaranty | 12 Months Ended |
Dec. 31, 2023 | |
Credit Agreement and Guaranty | |
Credit Agreement and Guaranty | 8. Credit Agreement and Guaranty The facility was scheduled to mature on February 10, 2024 (“Maturity Date”) but was extended to March 11, 2024 (see Note 13). Borrowings under the Perceptive Credit Agreement accrue interest at an annual rate equal to the Secured Overnight Financing Rate for one-month deposits (“SOFR”) plus The Company may prepay any outstanding loans in whole or in part. Any such prepayment of the loans is subject to a prepayment premium of All of the Company’s obligations under the Perceptive Credit Agreement are secured by a first-priority lien and security interest in substantially all of the Company’s tangible and intangible assets, including intellectual property. The Perceptive Credit Agreement contains certain representations and warranties, affirmative covenants, negative covenants and conditions that are customary for similar financings. The negative covenants restrict or limit the ability of the Company to, among other things and subject to certain exceptions contained in the Perceptive Credit Agreement, incur new indebtedness; create liens on assets; engage in certain fundamental corporate changes, such as mergers or acquisitions, or changes to the Company’s business activities; make certain investments or restricted payments (each as defined in the Perceptive Credit Agreement); change its fiscal year; pay dividends; repay other certain indebtedness; engage in certain affiliate transactions; or enter into, amend or terminate any other agreements that have the impact of restricting the Company’s ability to make loan repayments under the Perceptive Credit Agreement. In addition, as amended by the Seventh Amendment, the Company must (i) at all times for the period from June 30, 2023 to October 31, 2023 maintain a minimum cash balance of In connection with the Perceptive Credit Agreement, the Company issued to Perceptive two warrants to purchase an aggregate of 700 shares of the Company’s common stock (together, the “2020 Perceptive Warrants”). The first warrant is exercisable for 350 shares of common stock at an exercise price of $7,480 per share. The second warrant is exercisable for 350 shares of common stock at an exercise price of $9,340 per share. The 2020 Perceptive Warrants expire on February 10, 2027. In connection with the Perceptive Credit Agreement, the Company issued to Perceptive a warrant to purchase 225 shares of the Company’s common stock (the “2021 Perceptive Warrant” and, together with the 2020 Perceptive Warrants, the “Perceptive Warrants”) at an exercise price of $5,740 per share. The 2021 Perceptive Warrant expires on February 26, 2028. In connection with the Sixth Amendment, the Company amended the Perceptive Warrants to reset the exercise price to $10.50 per warrant. In connection with the Seventh Amendment, the Company further amended the Perceptive Warrants to reset the exercise price to As a result of the public offering of the Company’s common stock completed in October 2021 (see Note 9), the antidilution provision of the Perceptive Warrants was triggered, resulting in a reduction of the strike price for the Perceptive Warrants. Warrants to purchase 350 shares of common stock that had an exercise price of $9,340 per share were reduced to $7,080 per share, warrants to purchase 350 shares of common stock that had an exercise price of $7,480 per share were reduced to $5,760 per share, and warrants to purchase 225 shares of common stock that had an exercise price of $5,740 per share were reduced to $4,540 per share. As a result of the registered direct offering completed in March 2022 (see Note 8), the anti-dilution provision of the Perceptive Warrants was again triggered resulting in a further reduction of the strike price for the Perceptive Warrants. Warrants to purchase 350 shares of common stock that had an adjusted exercise price of $7,080 per share were reduced to $5,276 per share, warrants to purchase 350 shares of common stock that had an adjusted exercise price of $5,760 per share were reduced to $4,330.50 per share, and warrants to purchase 225 shares of common stock that had an adjusted exercise price of $4,540 per share were reduced to $3,456.50 per share. As a result of the public offering of the Company’s common stock completed in July 2022 (see Note 8), the antidilution provision of the Perceptive Warrants was again triggered resulting in a reduction of the strike price for the Perceptive Warrants. Warrants to purchase 350 shares of common stock that had an exercise price of $5,276 per share were reduced to $745 per share, warrants to purchase 350 shares of common stock that had an exercise price of $4,330.50 per share were reduced to $618.50 per share, and warrants to purchase 225 shares of common stock that had an exercise price of $3,456.50 per share were reduced to $501.50 per share. As a result of the public offering of the Company’s common stock completed in May 2023 (see Note 8), the antidilution provision of the Perceptive Warrants was again triggered resulting in a reduction of the strike price for the Perceptive Warrants. Warrants to purchase 350 shares of common stock that had an exercise price of $745 per share were reduced to $3.69 per share, warrants to purchase 350 shares of common stock that had an exercise price of $618.50 per share were reduced to $3.69 per share, and warrants to purchase 225 shares of common stock that had an exercise price of $501.50 per share were reduced to $3.69 per share. The Company allocated the proceeds of December 31, December 31, 2023 2022 Long-term debt $ 1,650 $ 2,625 Debt issuance costs (23) (209) Warrant discount (112) (990) Total debt $ 1,515 $ 1,426 Less, current portion 1,515 1,426 Long-term debt, less current portion $ — $ — The fair value of the warrants and the debt issue costs are being amortized utilizing the effective interest method over the term of the loan. The Company recorded interest expense for the amortization of the fair value of the warrants and debt issue costs of $1,063,000, $1,969,000 and $1,661,000 for the years ended December 31, 2023, 2022, and 2021 respectively. |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) | 12 Months Ended |
Dec. 31, 2023 | |
Stockholders' Equity (Deficit) | |
Stockholders' Equity (Deficit) | 9. Stockholders’ Equity (Deficit) On January 7, 2022, the Company’s stockholders approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase the number of shares of common stock authorized for issuance from 150,000,000 shares to 300,000,000 shares. Reverse Stock Split On April 10, 2023, the Company filed with the Secretary of State of the State of Delaware a certificate of amendment, or the Certificate of Amendment, to the Company’s Amended and Restated Certificate of Incorporation, which became effective on April 10, 2023 . The Certificate of Amendment implemented a 1 issued outstanding Shelf Registration Statement On October 2, 2020, the Company filed a universal shelf registration statement with the SEC for the issuance of common stock, preferred stock, warrants, rights, debt securities and units up to an aggregate amount of $200.0 million (the “2020 Shelf Registration Statement”). On October 14, 2020, the 2020 Shelf Registration Statement was declared effective by the SEC. In the future, the Company may periodically offer one or more of these securities in amounts, prices and terms to be announced when and if the securities are offered. At the time any of the securities covered by the 2020 Shelf Registration Statement are offered for sale, a prospectus supplement will be prepared and filed with the SEC containing specific information about the terms of any such offering. The 2020 Shelf Registration Statement expired on October 13, 2023. Public Offerings In October 2021, the Company completed a public offering of 13,333 shares of its common stock and warrants to purchase 6,660 shares of its common stock at a combined price of $1,700 per share of common stock and one-half of a warrant to purchase one share of common stock. Proceeds from the public offering, net of underwriting discounts, commissions and offering expenses were approximately $21.1 million. In July 2022, the Company completed a best efforts public offering (the “2022 Offering”) in which the Company raised net proceeds of $22.0 million through the sale of 382,966 shares of common stock and 150,366 pre-funded warrants (“Series B pre-funded warrants”) to purchase 150,367 shares of common stock at a combined price of $45.00 per share of common stock and warrants. Both the sales of shares of common stock and pre-funded warrants were accompanied by Series A-1 and Series A-2 warrants (together the “Series A warrants”) to purchase shares of common stock. The Series A-1 warrants are exercisable immediately and will expire five years from the date of issuance, and the Series A-2 warrants expired unexercised in August 2023. H.C. Wainwright acted as the exclusive placement agent in connection with the 2022 Offering and, as compensation, received a cash fee of 7% of the aggregate proceeds raised in the 2022 Offering. The Company also issued to certain designees of H.C. Wainwright warrants to purchase up to 26,666 shares of common stock with an exercise price of $56.25 per share. In May 2023, the Company completed a best-efforts public offering of an aggregate of 95,000 shares of common stock and 1,801,286 pre-funded warrants in lieu of shares of common stock and warrants to purchase a total of 3,792,572 shares of common stock at combined public offering price of $3.9551 per share. Proceeds from the public offering, net of underwriting discounts, commissions, and offering expenses were approximately $6.5 million. Through December 31, 2023 all of the 1,801,286 pre-funded warrants had been exercised. H.C. Wainwright acted as the exclusive placement agent in connection with the Offering and, as compensation, received a cash fee of 7% of the aggregate proceeds raised in the Offering. The Company also issued to certain designees of H.C. Wainwright warrants to purchase up to 94,814 shares of commons stock with an exercise price of $4.9439 per share. In December 2023, the Company entered into a Warrant Amendment and Additional Issuance Agreement relating to the amendment of warrants to purchase shares of common stock that were issued in transactions on March 14, 2022, April 25, 2022, and May 25, 2023. Collectively, the Warrants represent the right to purchase approximately 3.8 million shares of common stock. Under the terms of the Warrant Amendment and Additional Issuance Agreement, the holder agreed to revise certain provisions and in exchange for the holder’s agreement to amend the Warrants, the Company agreed to issue an additional new warrant (the “New Warrant”) to purchase The Company has accounted for the warrants as liabilities, while the pre-funded warrants are classified as a component of permanent equity within additional paid-in capital because they are freestanding financial instruments that are legally detachable and separately exercisable from the shares of common stock with which they were issued, are immediately exercisable, do not embody an obligation for the Company to repurchase its shares, and permit the holders to receive a fixed number of shares of common stock upon exercise. The Company also determined that the pre-funded warrants should be included in the determination of basic earnings per share in accordance with ASC 260, Earnings per Share ATM Sales Agreements In March 2021, the Company entered into a common stock sales agreement (the “Sales Agreement”) under which the Company may sell up to an aggregate of $50.0 million in gross proceeds through the sale of shares of common stock from time to time in “at-the-market” equity offerings (as defined in Rule 415 promulgated under the Securities Act of 1933, as amended). The Company agreed to pay a commission of up to 3% of the gross proceeds of any common stock sold under the Sales Agreement. During the year ended December 31, 2021, the Company issued and sold 3,458 shares of common stock under the Sales Agreement resulting in net proceeds to the Company of approximately $9.3 million. On January 10, 2022, the Company filed a prospectus supplement to its 2020 Shelf Registration Statement registering an at-the-market offering program (the “2022 ATM”) the Company entered into for the sale of up to $50.0 million of shares of its common stock. The Company agreed to pay a commission of up to 3% of the gross proceeds of any common stock sold under the Sales Agreement. During the three months ended March 31, 2022, the Company issued and sold 512 shares of common stock under the Sales Agreement resulting in net proceeds to the Company of approximately $0.3 million. On April 26, 2022, the Company terminated the 2022 ATM. On April 27, 2022, the Company entered into a new at-the-market offering program (the “April 2022 ATM Agreement”) with H.C. Wainwright LLC and Co. (the “Sales Agent”) under which the Company is authorized to sell up to an aggregate of $12.8 million in gross proceeds through the sale of shares of common stock from time to time. The Company agreed to pay a commission of up to 3.0% of the gross proceeds of any common stock sold under the April 2022 ATM Agreement. Through September 30, 2022, the Company issued and sold a total of 173,750 shares of common stock under the April 2022 ATM Agreement, representing the entire capacity of the April 2022 ATM, resulting in net proceeds of approximately $12.2 million. On August 22, 2022, the Company increased the April 2022 ATM (“August 2022 ATM”). As increased, the Company was eligible to offer and sell, from time to time through the Sales Agent, shares of its common stock having an aggregate offering price of up to $75.0 million. During the year ended December 31, 2022, the Company issued and sold 78,853 shares of common stock under the August 2022 ATM resulting in net proceeds of approximately $0.9 million. On April 12, 2023, the Company filed a prospectus supplement to its registration statement on Form S-3 for the August 2022 ATM verifying that it is now eligible to sell up to $4.5 million worth of shares through its ATM. During the year ended December 31, 2023, the Company issued and sold 207,883 shares for net proceeds of approximately $1.7 million. Registered Direct Offering On March 14, 2022, the Company filed a prospectus supplement to its 2020 Shelf Registration Statement registering a direct offering (the “2022 Preferred Stock Offering”) of 2,425 shares of Series A convertible preferred stock (the “Series A Preferred Stock”) and 2,425 shares of Series B convertible preferred stock (the “Series B Preferred Stock”) and Series A warrants (the “Series A Warrants”) to purchase up to an aggregate of 12,125 shares of the common stock of the Company and Series B warrants (the “Series B Warrants”) to purchase up to an aggregate of 12,125 shares of common stock. Each share of Series A Preferred Stock and Series B Preferred Stock has a stated value of $1,000 per share and a conversion price of $400.00 per share. The shares of preferred stock issued in the 2022 Preferred Stock Offering are convertible into an aggregate of 12,125 shares of common stock. The Series A Warrants have an exercise price of $520.00 per share, will become exercisable six months following the date of issuance, and will expire 5 years following the initial exercise date. The Series B Warrants have an exercise price of $520.00 per share, will become exercisable six months following the date of issuance, and will expire one and one-half years following the initial exercise date. On March 15, 2022, 2,425 shares of the Series A Preferred Stock were converted into 6,063 shares of the Company’s common stock. On April 4, 2022, 2,425 shares of the Series B Preferred Stock were converted into 6,063 shares of the Company’s common stock. On April 25, 2022, the Company entered into a letter agreement and waiver (the “Letter Agreement”) with Armistice Capital Master Fund Ltd. (“Armistice”), pursuant to which Armistice consented to the Company entering into and effecting an at-the-market (“ATM”) offering facility. On March 14, 2022, the Company entered into the 2022 Preferred Stock Offering with Armistice, under which agreement, the Company was restricted from entering into and effecting an ATM offering facility until the 180-day anniversary of the Closing Date. Pursuant to the Letter Agreement, the Company issued to Armistice a new common stock purchase warrant (“New Warrant”), on the same terms and conditions as the Series A Warrants, provided that such New Warrant shall be exercisable into 4,243 warrant shares. The Series A Warrants have an exercise price of $520.00 per share and will become exercisable six months following the date of issuance and will expire 5 years following the initial exercise date. The New Warrant is exercisable 6 months after the date of the Letter Agreement. |
Equity Incentive Plans
Equity Incentive Plans | 12 Months Ended |
Dec. 31, 2023 | |
Equity Incentive Plans | |
Equity Incentive Plans | 10. Equity Incentive Plans Stock options The Company had granted stock options under an amended and restated 1997 Equity Incentive Plan (the “1997 Plan”) and a 2008 Equity Incentive Plan (the “2008 Plan”). The plans provided for the granting of incentive and non-statutory options and stock awards to consultants, directors, officers and employees. Such options are exercisable for a period of ten years and generally vest over a four-year period. In conjunction with the adoption of the 2008 Plan in April 2008, no additional grants were made from the 1997 Plan and issued options from the 1997 Plan remain outstanding. In 2014, the Board approved the 2014 Incentive Compensation Plan (the “2014 Plan”). The 2014 Plan is the successor to the Company’s 2008 Plan and 1997 Plan. In conjunction with the adoption of the 2014 Plan in 2014, no additional grants were made from the 2008 Plan and options from the 1997 Plan and the 2008 Plan remain outstanding. In June 2018, the 2014 Plan was amended and restated, and the Amended and Restated 2014 Incentive Compensation Plan is now referred to as the Amended 2014 Plan. In June 2023 the Company’s stockholders approved the Agile Therapeutics, Inc. 2023 Equity Incentive Plan. As of December 31, 2023, there were Through December 31, 2023, the Company granted options to certain employees and non-employees to purchase shares of common stock at exercise prices ranging from $10.00 to $21,500.00 per share. The Company recorded noncash stock-based compensation expense for the years ended December 31, 2023, 2022 and 2021 based on the fair market value of the options and shares granted at the grant date. Stock-based compensation expense was as follows: Year Ended December 31, 2023 2022 2021 Cost of product revenues $ 107 $ 133 $ 271 Research and development 358 372 490 Selling and marketing 102 155 148 General and administrative 1,414 1,832 2,429 Total $ 1,981 $ 2,492 $ 3,338 The following assumptions were used to compute employee stock-based compensation under the Black-Scholes option pricing model: 2023 2022 2021 Risk‑free interest rate 3.87%-3.90 % 1.71% - 4.22 % .66% - 1.51 % Expected volatility 115.9%-118.6 % 107% ‑ 118 % 105% ‑ 106 % Expected dividend yield 0 % 0 % 0 % Expected life (in years) 6.25 6.25 6.25 Risk-free interest rate. The Company bases the risk-free interest rate assumption on observed interest rates appropriate for the expected term of the stock option grants. Expected dividend yield. The Company bases the expected dividend yield assumption on the fact that it has never paid cash dividends and has no present intention to pay cash dividends. Expected volatility. Since August 2020, the Company transitioned to its own expected volatility based on historical data. Expected term. The expected term represents the period of time that options are expected to be outstanding. Because the Company does not have historical exercise behavior, management determined the expected life assumption using the simplified method, which is an average of the contractual term of the option and its ordinary vesting period. Forfeitures. As of December 31, 2023, the unrecorded deferred stock-based compensation balance related to stock options was approximately $1.4 million and will be recognized over an estimated weighted-average amortization period of 2.8 years. The weighted average grant date fair value of options granted during the year ended December 31, 2023 was The following table summarizes the options outstanding, options vested and the options exercisable as of December 31, 2023, 2022 and 2021: Weighted Weighted Average Average Remaining Exercise Contractual Aggregate Options Price Life (Years) Intrinsic Value Options outstanding at December 31, 2021 5,183 5,666.50 6.1 Options granted 3,749 198.50 Options exercised — — Options cancelled/forfeited (1,004) 4,872.00 Options outstanding at December 31, 2022 7,928 3,187.50 7.7 Options granted 35,825 2.64 Options exercised — — Options cancelled/forfeited (710) 2,398.42 Options outstanding at December 31, 2023 43,043 548.70 9.0 $ — Options exercisable at December 31, 2023 5,007 4,438.73 5.8 $ — Vested and expected to vest at December 31, 2023 43,043 $ — Intrinsic value in the tables was calculated as the difference between the Company's stock price at December 29, 2023, of $1.95 per share, and the exercise price, multiplied by the number of options. Restricted Stock Units During the year ended December 31, 2021, the Company granted a total of 35 RSUs to certain employees of the Company. These RSUs vested on the anniversary of the grant date. During the year ended December 31, 2021, the Company granted a total of RSUs to directors of the Company. These RSUs vest ratably over one . During the year ended December 31, 2022, the Company granted a total of 94 RSUs to directors of the Company. These RSUs vest ratably over . During the year ended December 31, 2023, the Company granted a total of 155,004 RSUs to certain employees and directors of the Company. These RSUs vest ratably over one As of December 31, 2023, the unrecorded deferred stock-based compensation balance related to RSUs was approximately $0.3 million and will be recognized over an estimated weighted-average amortization period of 3.11 years. The following table shows the Company's restricted stock unit activity during the years ended December 31, 2023, and 2022: Weighted Average Aggregate Shares Grant Date Fair Value Intrinsic Value Restricted stock units outstanding at December 31, 2021 167 $ 163 Granted 94 52.50 Vested (135) 3,815.00 Restricted stock units outstanding at December 31, 2022 125 — $ 163 Granted 155,004 2.46 Vested (112) 674.63 Forfeited (1,500) 2.48 Restricted stock units outstanding at December 31, 2023 153,517 $ 299 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Taxes | |
Income Taxes | 11. Income Taxes On March 27, 2020 the US government enacted the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) which includes numerous modifications to income tax provisions, including a limitation on business interest expense and net operating loss provisions and the acceleration of alternative minimum tax credits. Given the Company’s history of losses, the CARES Act did not have a material impact on its tax provision. As of December 31, 2023, the Company had available net operating loss carryforwards (“NOLs”) of approximately $396.5 million for federal and $77.4 million for state income tax reporting purposes. Under the TCJA, the federal NOLs generated after 2017, approximately $209.6 million, can be carried forward indefinitely, while the NOLs generated through taxable years ending December 31, 2017, approximately $186.9 million, are available to offset future federal taxable income, if any, through 2037 and will begin to expire in 2024 in varying amounts if not utilized. The Company also has research and development tax credit carryforwards of approximately $6.3 million and $0.9 million for federal and state income tax reporting purposes, respectively, which are available to reduce federal income taxes, if any, through 2042 and state income taxes, if any, through 2037. The federal credits will begin to expire in 2024 in varying amounts if not utilized. The Internal Revenue Code of 1986, as amended (the “Code”) provides for a limitation on the annual use of NOLs and other tax attributes (such as research and development tax credit carryforwards) following certain ownership changes, as defined by the Code that could significantly limit the Company’s ability to utilize these carryforwards. At this time, the Company has not completed a study to assess whether an ownership change under Section 382 of the Code has occurred, or whether there have been multiple ownership changes since the Company’s formation, due to the costs and complexities associated with such a study. The Company is likely to have experienced various ownership changes, as defined by the Code, as a result of past financings. Accordingly, the Company’s ability to utilize the aforementioned carryforwards may be limited. Additionally, U.S. tax laws limit the time during which these carryforwards may be applied against future taxes. Therefore, the Company may not be able to take full advantage of these carryforwards for federal and state income tax purposes. The Company does not have any significant unrecognized tax benefits. The Company’s policy is to recognize interest and penalties related to uncertain tax positions in the income tax provision; however, as of December 31, 2023, the Company has not accrued any interest or penalties related to uncertain tax positions. The Company’s tax returns for the years ended December 31, 2020 through December 31, 2022 are still subject to examination by major tax jurisdictions. However, the Internal Revenue Service (“IRS”) and state tax jurisdictions can audit the NOLs generated in prior years in the years that those NOLs are utilized. For all years through December 31, 2023, the Company generated research credits but has not conducted a study to document the qualified activities. This study may result in an adjustment to the Company’s research and development credit carryforwards; however, until a study is completed and any adjustment is known, no amounts are being presented as an uncertain tax position. A full valuation allowance has been provided against the Company’s research and development credits and, if an adjustment is required, this adjustment would be offset by an adjustment to the deferred tax asset established for the research and development credit carryforwards and the valuation allowance. The tax effects of temporary differences that give rise to significant portions of the deferred tax assets are presented below: December 31, 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 88,279 $ 87,216 Research credit carryforward 7,026 7,071 Capitalized research and development expenses 164 205 Stock options and other 5,028 2,092 Total gross deferred tax assets 100,497 96,584 Valuation allowance for deferred tax assets (100,497) (96,584) Net deferred tax assets $ — $ — The net change in the valuation allowance for the years ended December 31, 2023 and 2022 was an increase of $3.9 million and an increase of $5.4 million, respectively. A reconciliation of the U.S. statutory income tax rate to the Company’s effective tax rate is as follows: December 31, 2023 2022 2021 Federal income tax at statutory rate 21.0 % 21.0 % 21.0 % State income tax benefit, net of federal benefit 0.9 % 0.1 % 0.2 % Unrealized gain on warrants 9.8 % 17.8 % 1.1 % Research and development tax credits — % 0.1 % 0.2 % Other (4.6) % (5.5) % (2.2) % Increase to valuation allowance (27.1) % (18.0) % (20.3) % Effective income tax rate 0.0 % 15.5 % 0.0 % Sale of New Jersey Net Operating Losses The Company has participated in the State of New Jersey’s Technology Business Tax Certificate Transfer Program (the “Program”) sponsored by The New Jersey Economic Development Authority. The Program enables approved biotechnology companies with unused NOLs and unused research and development credits to sell these tax benefits for at least 80% of the value of the tax benefits to unaffiliated, profitable corporate taxpayers in the State of New Jersey. The Program is administered by The New Jersey Economic Development Authority and the New Jersey Department of the Treasury’s Division of Taxation. The Company had previously reached the maximum lifetime benefit of $15.0 million under the historical Program, however in January 2021 the Program was amended to extend the maximum lifetime benefit to $20.0 million. In March 2022, the Company completed the sale of NOLs totaling approximately |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies | |
Commitments and Contingencies | 12. Commitments and Contingencies The Company has several firm purchase commitments, primarily related to the manufacture and supply of Twirla and the supply of a field force of sales representatives to provide certain detailing services, sales operation services, compliance services, and training services. Future firm purchase commitments under these agreements, the last of which ends in 2033, as well as the Company’s operating lease (see Note 7) total million. This amount does not represent all of the Company’s anticipated purchases in the future, but instead represents only purchases that are the subject of contractually obligated minimum purchases. The minimum commitments disclosed are determined based on non-cancelable minimum spend in 2024 or termination amounts. Additionally, the Company purchases products and services as needed with no firm commitment. In April 2020, the Company entered into a manufacturing and commercialization agreement with Corium (the “Corium Agreement”). Under the Corium Agreement, the Company has a requirement to order quarterly minimum volumes of approximately $5.6 million of product. In the event that the Company does not order the minimum volume, the Company is required to pay an additional fee equal to twenty-five percent (25%) per unit of the transfer price for all units ordered in that quarter. The Company did not meet the minimum volume order in the first or second quarter of 2022, and has, therefore, paid the additional 25% per unit fee as a penalty for all units ordered during the period. Based on then-current demand expectations for Twirla, the Company did not expect to meet the minimum volume order for the balance of 2022 and would be subject to the additional fee on future purchases. On July 25, 2022 the Company and Corium entered into Amendment No. 1 to the Corium Agreement (the “Amendment”) that is designed to restructure the contract minimums applicable to the purchase of manufactured Twirla and other services provided by Corium, transfer equipment ownership to Corium to support the manufacture of Twirla and extend the term of the Corium Agreement. Pursuant to the Amendment, the parties agreed to adjust the process for the Company providing Corium certain binding and non-binding forecasts required under the Corium Agreement. Additionally, Corium will not enforce the original quantity minimums in the Corium Agreement, which are waived and replaced by new minimums that are based on Corium’s revenue for product purchased by the Company, expiring raw materials, and other services billed by Corium to support batch production and release. The guaranteed minimum revenue requirement for 2024 and each year thereafter is $22.5 million. In the event that the Company does not meet the guaranteed minimum revenue requirements in any given year, the Company will be required to make additional payments to Corium for the shortfall. The Company agreed to make certain monthly supplemental payments to Corium through December 2023, which payments are eligible to be retroactively reduced based upon product orders placed by the Company during 2023 meeting certain designated thresholds. In connection with the supplemental payments, Corium will retain the proceeds for the sale of certain raw materials to which the Company would otherwise have economic right to offset such supplemental payments. Further, the Company agreed to reimburse Corium for any unused raw materials in the event the Company’s actual product requirements are lower than initially forecasted. Pursuant to the Amendment, the term of the Corium Agreement was extended to December 31, 2033. Pursuant to the Amendment, the parties agreed to transfer ownership of certain manufacturing equipment used in the manufacture of Twirla from the Company to Corium under a Bill of Sale dated July 25, 2022. The Company records a provision for contingent losses when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. An unfavorable outcome to any legal matter, if material, could have an adverse effect on the Company's operations or its financial position. As of December 31, 2023, the Company has not recorded a provision for any contingent losses. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events | |
Subsequent Events | 13. Subsequent Events Warrant Exercise On February 22, 2024, the Company entered into a warrant exercise agreement (the “Exercise Agreement”) with a certain holder of its Warrants issued on July 6, 2022 and May 23, 2022 which were amended on December 3, 2023 (the “Exercising Holder”) wherein the Exercising Holder agreed to exercise a total of 3,892,572 warrants for cash, at an exercise price reduced by the Company to $1.25 per share (the “Warrant Exercise”). The gross proceeds from the Warrant Exercise were approximately $4.8 million before deducting placement agent fees and other expenses. In consideration for the Warrant Exercise, the Company issued new unregistered warrants to purchase shares of Common Stock (the “New Warrants”). The New Warrants are exercisable for an aggregate of up to 7,785,144 shares of Common Stock, at an exercise price of $1.00 per share and will be immediately exercisable upon issuance. 3,992,572 of the New Warrants will have a term of five years from the issuance date and 3,792,572 of the New Warrants will have a term of eighteen months from the issuance date. The exercise price of the New Warrants is subject to adjustment for stock splits, reverse splits, and similar capital transactions as described in the New Warrants. H.C. Wainwright & Co., LLC acted as placement agent and financial advisor in connection with the transaction and will receive a cash fee of 7.0% of the gross proceeds resulting from the Warrant Exercise, a management fee of 1.0% of the gross proceeds resulting from the Warrant Exercise and warrants (the “Placement Agent Warrants”) to purchase a number of shares of Common Stock equal to 5.0% of the number of Warrants exercised at an exercise price of $1.5625. Perceptive Credit Agreement On February 9, 2024, the Company and Perceptive entered into an eighth amendment to the Perceptive Credit Agreement (the “Eighth Amendment”). The Eighth Amendment extended the maturity date of the Perceptive Credit Agreement from February 10, 2024 until March 11, 2024 (the “Maturity Date”). Effective December 1, 2023, the Company has been making monthly payments of |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying financial statements have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) and include all adjustments necessary for the fair presentation of the Company's financial position for the periods presented. |
Use of Estimates | Use of Estimates The preparation of the Company’s financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company bases its estimates and judgments on historical experience and various other assumptions that it believes are reasonable under the circumstances. The amounts of assets and liabilities reported in the Company’s balance sheets and the amounts of revenue and expenses reported for each of the periods presented are affected by estimates and assumptions, which are used for, but not limited to, revenue recognition, inventory reserves, the accounting for common stock warrants, stock-based compensation, and accounting for research and development costs. As future events and their effects cannot be determined with precision, actual results could differ significantly from these estimates. |
Risks and Uncertainties | Risks and Uncertainties While Twirla has been approved by the FDA, other potential product candidates developed by the Company will require approval from the FDA prior to commercial sales. There can be no assurance that the Company’s other product candidates will receive the required approval. If the Company is denied approval or such approval is delayed or is unable to obtain the necessary financing to complete development and approval, there could be a material adverse impact on the Company’s financial condition and results of operations. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly-liquid investments with an original maturity of three months or less when purchased to be cash equivalents. All cash and cash equivalents are held in United States financial institutions. Cash and cash equivalents include money market funds that invest primarily in commercial paper and U.S. government and U.S. government agency obligations. The Company maintains balances with financial institutions in excess of the Federal Deposit Insurance Corporation limit. |
Accounts Receivable and Allowances | Accounts Receivable and Allowances Accounts receivable are amounts owed to the Company by its customers for product that has been delivered. The accounts receivable are recorded at the invoice amount, less prompt pay and other discounts, chargebacks, and an allowance for credit losses, if any. The allowance for credit losses represents the Company’s estimate of losses over the life of the receivables. The Company evaluates forward-looking economic factors and uses professional judgment to determine the allowance for credit losses. The credit loss reserves are reviewed and adjusted periodically. Credit loss reserves were not material as of December 31, 2023 and 2022, respectively. Accounts receivable are aged based on the contractual payment terms. When the collectability of an invoice is no longer probable, the Company will create a reserve for that specific receivable. If a receivable is determined to be uncollectible, it is charged against the general credit loss reserve or the reserve for the specific receivable, if one exists. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments In accordance with Accounting Standards Codification (“ASC”) 825, Financial Instruments Other financial instruments, including accounts receivable, accounts payable and accrued liabilities, are carried at cost which approximates fair value given their short-term nature. |
Inventory | Inventory Inventory is valued utilizing the weighted average costing method. The Company records an inventory reserve for losses associated with dated, expired, excess or obsolete items. This reserve is based on management’s current knowledge with respect to inventory levels, planned production and sales volume assumptions. As of December 31, 2023 and 2022 inventory reserves approximated |
Property and Equipment | Property and Equipment Property and equipment, consisting of office equipment, computer equipment and manufacturing equipment, is stated at cost, less accumulated depreciation. Depreciation is computed using the straight- line method over the estimated useful lives of the assets. Expenditures incurred after the fixed assets have been put into operation, such as repairs and maintenance, are charged to earnings in the period in which costs are incurred. Improvements and additions are capitalized in accordance with Company policy. In the third quarter of 2022, the Company transferred manufacturing equipment with a book value of $11.1 million to Corium in exchange for relief from minimum material purchase requirements. The Company recorded a loss of |
Long-Lived Assets | Long-Lived Assets In accordance with ASC 360, Property, Plant and Equipment |
Research and Development Expense | Research and Development Expense Research and development costs are expensed as incurred. Research and development expense consists primarily of costs related to personnel, including salaries and other personnel-related expenses, expenses related to manufacturing, clinical trial expenses, consulting fees and support services used in drug development. All research and development costs are charged to operations as incurred in accordance with ASC 730, Research and Development In certain circumstances, the Company is required to make advance payments to vendors for goods or services that will be received in the future for use in research and development activities. In such circumstances, the advance payments are deferred and are expensed when the activity has been performed or when the goods have been received. |
Advertising Costs | Advertising Costs The Company has elected to expense advertising costs when incurred. Advertising costs totaled |
Deferred Financing Costs | Deferred Financing Costs Costs directly attributable to the Company’s term loan (see Note 8) are deferred and reported as a reduction of the related term loan. These costs represent legal fees and other costs related to the term loan and are being amortized utilizing the straight-line method over the term of the loan. Amortization of deferred financing costs charged to interest expense was approximately $185,000, $342,000 and $277,000 for the years ended December 31, 2023, 2022 and 2021, respectively. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments which potentially subject the Company to credit risk consist principally of cash, cash equivalents, and accounts receivable. The Company invests its cash and cash equivalents in interest-bearing accounts in United States financial institutions, the balances of which exceed federally insured limits. The Company mitigates credit risk by limiting the investment type and maturity to securities that preserve capital, maintain liquidity, and have a high credit quality. The Company has not recognized any losses from credit risks on such accounts. The Company has Major customers of the Company are defined as those constituting greater than 10% of its total revenue. In 2023, the Company had sales to five customers that individually accounted for more than 10% of total revenue. These customers had sales of $4.7 million, $3.8 million, $3.7 million, $3.5 million and $2.8 million, respectively, which represented 94% of the Company’s total revenue for 2023. Accounts receivable related to these five customers comprised 6%, 30%, 30%, 29% and 0% of the Company’s total accounts receivable, respectively, as of December 31, 2023. In 2022, the Company had sales to $2.9 million, $2.7 million, $2.6 million and $1.2 million, respectively, which represented 86% of the Company’s total revenue for 2022. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue from the sale of its product, Twirla, in accordance with ASC 606, Revenue from Contracts with Customers In accordance with ASC 606, the Company recognizes revenue at the point in time when its performance obligation is satisfied by transferring control of the promised goods or services to a customer. In accordance with the Company’s contracts with customers, control of the product is transferred upon the conveyance of title, which occurs when the product is sold to and received by a customer. The Company’s customers are located in the United States and consist primarily of wholesale distributors. Accounts receivable due to the Company from contracts with its customers are stated separately in the balance sheet, net of various allowances as described later in this section and in the Accounts Receivable and Allowance policy. The amount of revenue recognized by the Company is equal to the amount of consideration that is expected to be received from the sale of product to its customers. Revenue is only recognized when it is probable that a significant reversal will not occur in future periods. To determine whether a significant reversal will occur in future periods, the Company assesses both the likelihood and magnitude of any such potential reversal of revenue. Twirla is sold to customers at the wholesale acquisition cost (“WAC”). However, the Company records product revenue, net of reserves for applicable variable consideration. These types of variable consideration items reduce revenue and include the following: ● Distribution services fees; ● Prompt pay and other discounts; ● Product returns; ● Chargebacks; ● Rebates; and ● Co-payment assistance. An estimate for each variable consideration item is made and is recorded in conjunction with the revenue being recognized. Generally, if the estimated amount is payable to a customer, it is recorded as a reduction to accounts receivable. If the estimated amount is payable to an entity other than a customer, it is recorded as a current liability. An estimated amount of variable consideration may differ from the actual amount. At each balance sheet date, these provisions are analyzed, and adjustments are made if necessary. Any adjustments made to these provisions would affect net product revenue and earnings in the current period. In accordance with ASC 606, the Company must make judgments to determine the estimate for certain variable consideration. For example, the Company must estimate the percentage of end-users that will obtain the product through public insurance such as Medicaid or through private commercial insurance. To determine these estimates, the Company had relied on quantitative and qualitative data from various internal and external sources to estimate its variable consideration. The specific considerations that the Company uses in estimating these amounts related to variable considerations are as follows: Distribution services fees – The Company pays distribution service fees primarily to its wholesale distributors. These fees are a contractually fixed percentage of WAC and are calculated at the time of sale based on the purchase amount. The Company records these fees as contra accounts receivable on the balance sheet. Prompt pay and other discount The Company may also give other discounts to its customers to incentivize purchases and promote customer loyalty. The terms of such discounts may vary by customer. These discounts reduce gross product revenue at the time the revenue is recorded. Product returns Chargebacks Rebates Co-payment assistance Customer credits, Rebates and co-pay discounts and allowances assistance Product returns (contra accounts receivable) (accrued expenses) (accrued expenses) Total Balance as of December 31, 2021 $ 371 $ 528 $ 141 $ 1,040 Allowances for current period sales 5,891 4,035 399 10,325 Payments and credits (3,268) (2,574) (197) (6,039) Balance as of December 31, 2022 2,994 1,989 343 5,326 Allowances for current period sales 18,385 8,192 2,964 29,541 Payments and credits (16,665) (5,564) (1,432) (23,661) Balance as of December 31, 2023 $ 4,714 $ 4,617 $ 1,875 $ 11,206 |
Warrants | Warrants The Company accounts for its warrants to purchase common stock in accordance with ASC 480, Distinguishing Liabilities from Equity . In connection with entering into a senior secured term loan facility in February 2020 (the “Perceptive Credit Agreement”), the Company issued warrants to purchase shares of its common stock to the lender, Perceptive Credit Holdings III, L.P. (“Perceptive”). In connection with an amendment to that facility in February 2021, the Company issued warrants to purchase In connection with an underwritten public offering completed in October 2021, the Company issued warrants to purchase 6,660 shares of its common stock. These warrants are classified as liabilities, were measured at fair value upon issuance, with subsequent changes in fair value reported in the Statements of Operations and Comprehensive Loss each reporting period. This offering also triggered an adjustment to the exercise price of the Perceptive Warrants, which resulted in a reduction of the strike price for these warrants. This reduction resulted in an immaterial increase to additional paid-in-capital. See Notes 8 and 9 for additional information. In connection with a registered direct offering completed in March 2022, the Company issued warrants to purchase shares of its common stock. These warrants are classified as liabilities, were measured at fair value upon issuance, with subsequent changes in fair value reported in the Statement of Operations and Comprehensive Loss each reporting period. This offering also triggered an adjustment to the exercise price of the Perceptive Warrants, which resulted in a reduction of the strike price for these warrants. This reduction resulted in an immaterial increase to additional paid-in-capital. See Notes 8 and 9 for additional information. In connection with a letter agreement and waiver entered into with an investor in April 2022, the Company issued warrants to purchase shares of common stock. These warrants are classified as liabilities, were measured at fair value upon issuance, with subsequent changes in fair value reported in the Statement of Operations and Comprehensive Loss each reporting period. See Note 9 for additional information. In connection with a public offering completed in July 2022, the Company issued warrants to purchase In connection with a public offering completed in May 2023, the Company issued warrants to purchase On December 3, 2023, the Company entered into a Warrant Amendment and Additional Issuance Agreement (“Warrant Amendment and Additional Issuance Agreement”) relating to the amendment of warrants to purchase shares of common stock that were issued in transactions on March 14, 2022, April 25, 2022, and May 25, 2023 (collectively, the “Warrants”). Collectively, the Warrants represent the right to purchase approximately |
Income Taxes | Income Taxes The Company accounts for deferred taxes using the asset and liability method as specified by ASC 740, Income Taxes The Company has adopted the authoritative guidance on accounting for and disclosure of uncertainty in tax positions, which prescribes a comprehensive model for the financial statement recognition, measurement, presentation, and disclosure of uncertain tax positions taken or expected to be taken in income tax returns. The Company has no uncertain tax positions as of December 31, 2023 that qualify for either recognition or disclosure in the financial statements under this guidance. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation . The Company grants stock options for a fixed number of shares to employees and non-employees with an exercise price equal to the fair value of the shares at grant date. Compensation cost is recognized for all share-based payments granted and is based on the grant-date fair value estimated using the weighted-average assumption of the Black-Scholes option pricing model based on key assumptions such as stock price, expected volatility and expected term. The Company elects to account for forfeitures when they occur. The equity instrument is not considered to be issued until the instrument vests. As a result, compensation cost is recognized over the requisite service period with an offsetting credit to additional paid-in capital. The Company also awards restricted stock units (“RSUs”) to employees and its board of directors. RSUs are generally subject to forfeiture if employment terminates prior to the completion of the vesting restrictions. The Company expenses the cost of the RSUs, which is determined to be the fair market value of the shares of common stock underlying the RSUs at the date of grant, ratably over the period during which the vesting restrictions lapse. |
Segment Information | Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating and reporting |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding plus the effect of dilutive potential common shares outstanding during the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, common stock warrants, unvested RSUs and stock options are considered to be potentially dilutive securities but are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and therefore, basic and diluted net loss per share were the same for all periods presented. The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share for the years ended December 31, 2023, 2022 and 2021, respectively, because to do so would be anti-dilutive (in common equivalent shares): Year Ended December 31, 2023 2022 2021 Common stock warrants 5,589,637 1,130,025 7,592 Unvested restricted stock units 173,517 129 167 Common stock options 43,043 7,956 5,183 Total 5,806,197 1,138,111 12,941 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (the “FASB”) or other standard setting bodies that are adopted by the Company as of the specified effective date. The Company did not adopt any new accounting pronouncements during the year ended December 31, 2023 that had a material effect on its financial statements. In November 2023, the FASB issued Accounting Standards Update (“ASU”) No. 2023-07, Segment Reporting (Topic 280) (“ASU 2023-07”). The guidance in ASU 2023-07 expands prior reportable segment disclosure requirements by requiring entities to disclose significant segment expenses that are regularly provided to the Chief Operating Decision Maker (“CODM”) and details of how the CODM uses financial reporting to assess their segment’s performance. The guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2023, with early adoption permitted. The Company is currently evaluating the impact that the adoption of ASU 2023-07 may have on its financial statements. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”). The guidance in ASU 2023-09 improves the transparency of income tax disclosures by greater disaggregation of information in the rate reconciliation and income taxes paid disaggregated by jurisdiction. The standard is effective for public companies for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact that the adoption of ASU 2023-09 may have on its financial statements. Management does not believe that any other recently issued, but not yet effective accounting pronouncements, if adopted, would have a material impact on the accompanying financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Summary of Significant Accounting Policies | |
Summary of sales allowances and related accruals | Customer credits, Rebates and co-pay discounts and allowances assistance Product returns (contra accounts receivable) (accrued expenses) (accrued expenses) Total Balance as of December 31, 2021 $ 371 $ 528 $ 141 $ 1,040 Allowances for current period sales 5,891 4,035 399 10,325 Payments and credits (3,268) (2,574) (197) (6,039) Balance as of December 31, 2022 2,994 1,989 343 5,326 Allowances for current period sales 18,385 8,192 2,964 29,541 Payments and credits (16,665) (5,564) (1,432) (23,661) Balance as of December 31, 2023 $ 4,714 $ 4,617 $ 1,875 $ 11,206 |
Schedule of outstanding potentially dilutive securities excluded from calculation of diluted net loss per share | The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share for the years ended December 31, 2023, 2022 and 2021, respectively, because to do so would be anti-dilutive (in common equivalent shares): Year Ended December 31, 2023 2022 2021 Common stock warrants 5,589,637 1,130,025 7,592 Unvested restricted stock units 173,517 129 167 Common stock options 43,043 7,956 5,183 Total 5,806,197 1,138,111 12,941 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Measurements | |
Schedule of financial instruments measured at fair value by level within the fair value hierarchy | Level 1 Level 2 Level 3 December 31, 2023 Assets: Cash and cash equivalents $ 2,557 $ — $ — Total assets at fair value $ 2,557 $ — $ — Liabilities: Warrant Liability $ — $ — $ 5,696 Total assets at fair value $ — $ — $ 5,696 Level 1 Level 2 Level 3 December 31, 2022 Assets: Cash and cash equivalents $ 5,246 $ — $ — Total assets at fair value $ 5,246 $ — $ — Liabilities: Warrant Liability $ — $ — $ 5,934 Total assets at fair value $ — $ — $ 5,934 |
Schedule of rollforward of the fair value of Level 3 warrants | Beginning balance at December 31, 2022 $ 5,934 Warrants issued 12,537 Change in fair value (12,775) Ending Balance December 31, 2023 $ 5,696 |
Prepaid Expenses (Tables)
Prepaid Expenses (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Prepaid Expenses | |
Schedule of prepaid expenses | December 31, 2023 2022 Prepaid insurance $ 441 $ 628 Other 402 775 Total prepaid expenses and other current assets $ 843 $ 1,403 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property and Equipment | |
Schedule of components of property and equipment | December 31, Estimated 2023 2022 Life Office equipment $ 132 $ 132 5 years Computer equipment 121 121 3 Years Manufacturing equipment — — 7 years 253 253 Less: accumulated depreciation (178) (76) Property and equipment $ 75 $ 177 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accrued Liabilities | |
Schedule of accrued liabilities | December 31, 2023 2022 Gross to net accruals $ 6,492 $ 2,332 Accrued compensation 832 833 Accrued professional fees and other 1,807 743 Total accrued liabilities $ 9,131 $ 3,908 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Leases | |
Maturity of lease liabilities | Future minimum lease payments under non-cancellable leases as of December 31, 2023 were as follows: 2024 $ 397 2025 101 Total $ 498 Less: Interest (32) Present value of lease liability $ 466 |
Credit Agreement and Guaranty (
Credit Agreement and Guaranty (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Credit Agreement and Guaranty | |
Schedule of carrying amount of term loan | December 31, December 31, 2023 2022 Long-term debt $ 1,650 $ 2,625 Debt issuance costs (23) (209) Warrant discount (112) (990) Total debt $ 1,515 $ 1,426 Less, current portion 1,515 1,426 Long-term debt, less current portion $ — $ — |
Equity Incentive Plans (Tables)
Equity Incentive Plans (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Equity Incentive Plans | |
Schedule of stock-based compensation expense | Year Ended December 31, 2023 2022 2021 Cost of product revenues $ 107 $ 133 $ 271 Research and development 358 372 490 Selling and marketing 102 155 148 General and administrative 1,414 1,832 2,429 Total $ 1,981 $ 2,492 $ 3,338 |
Schedule of assumptions used to compute employee stock-based compensation | 2023 2022 2021 Risk‑free interest rate 3.87%-3.90 % 1.71% - 4.22 % .66% - 1.51 % Expected volatility 115.9%-118.6 % 107% ‑ 118 % 105% ‑ 106 % Expected dividend yield 0 % 0 % 0 % Expected life (in years) 6.25 6.25 6.25 |
Summary of options outstanding, vested and exercisable | Weighted Weighted Average Average Remaining Exercise Contractual Aggregate Options Price Life (Years) Intrinsic Value Options outstanding at December 31, 2021 5,183 5,666.50 6.1 Options granted 3,749 198.50 Options exercised — — Options cancelled/forfeited (1,004) 4,872.00 Options outstanding at December 31, 2022 7,928 3,187.50 7.7 Options granted 35,825 2.64 Options exercised — — Options cancelled/forfeited (710) 2,398.42 Options outstanding at December 31, 2023 43,043 548.70 9.0 $ — Options exercisable at December 31, 2023 5,007 4,438.73 5.8 $ — Vested and expected to vest at December 31, 2023 43,043 $ — |
Schedule of restricted stock activity | Weighted Average Aggregate Shares Grant Date Fair Value Intrinsic Value Restricted stock units outstanding at December 31, 2021 167 $ 163 Granted 94 52.50 Vested (135) 3,815.00 Restricted stock units outstanding at December 31, 2022 125 — $ 163 Granted 155,004 2.46 Vested (112) 674.63 Forfeited (1,500) 2.48 Restricted stock units outstanding at December 31, 2023 153,517 $ 299 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Taxes | |
Schedule of tax effects of temporary differences that give rise to significant portions of deferred tax assets | December 31, 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 88,279 $ 87,216 Research credit carryforward 7,026 7,071 Capitalized research and development expenses 164 205 Stock options and other 5,028 2,092 Total gross deferred tax assets 100,497 96,584 Valuation allowance for deferred tax assets (100,497) (96,584) Net deferred tax assets $ — $ — |
Schedule of reconciliation of U.S. statutory income tax rate to effective tax rate | December 31, 2023 2022 2021 Federal income tax at statutory rate 21.0 % 21.0 % 21.0 % State income tax benefit, net of federal benefit 0.9 % 0.1 % 0.2 % Unrealized gain on warrants 9.8 % 17.8 % 1.1 % Research and development tax credits — % 0.1 % 0.2 % Other (4.6) % (5.5) % (2.2) % Increase to valuation allowance (27.1) % (18.0) % (20.3) % Effective income tax rate 0.0 % 15.5 % 0.0 % |
Organization and Description _2
Organization and Description of Business (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Nature of Operations | ||
Cash, cash equivalents and marketable securities | $ 2,500 | |
Working capital deficit | (11,200) | |
Accumulated deficit | $ 423,168 | $ 408,702 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Inventory (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Summary of Significant Accounting Policies | ||
Inventory reserve | $ 1.4 | $ 0.6 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Property and Equipment (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Sep. 30, 2022 | Dec. 31, 2022 | |
Loss on disposition of assets | $ (11,122) | |
Corium Agreement [Member] | ||
Minimum material purchase requirements | $ 11,100 | |
Loss on disposition of assets | $ (11,100) |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Advertising Costs (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Summary of Significant Accounting Policies | |||
Advertising costs | $ 0 | $ 8.2 | $ 13.8 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Deferred Financing Costs (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Interest expense | |||
Deferred Financing Costs | |||
Amortization of deferred financing costs | $ 185,000 | $ 342,000 | $ 277,000 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Concentrations of Credit Risk (Details) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 USD ($) customer | Dec. 31, 2022 USD ($) customer | Dec. 31, 2021 USD ($) | |
Concentration risk, financial liabilities | |||
Financial instruments with off-balance sheet risk of accounting loss, liabilities | $ 0 | ||
Total revenue | 19,593 | $ 10,884 | $ 4,101 |
Customer Concentration Risk | Sales Revenue | Customer One | |||
Concentration risk, financial liabilities | |||
Total revenue | 4,700 | 2,900 | |
Customer Concentration Risk | Sales Revenue | Customer Two | |||
Concentration risk, financial liabilities | |||
Total revenue | 3,800 | 2,700 | |
Customer Concentration Risk | Sales Revenue | Customer Three | |||
Concentration risk, financial liabilities | |||
Total revenue | 3,700 | 2,600 | |
Customer Concentration Risk | Sales Revenue | Customer Four | |||
Concentration risk, financial liabilities | |||
Total revenue | 3,500 | $ 1,200 | |
Customer Concentration Risk | Sales Revenue | Customer Five | |||
Concentration risk, financial liabilities | |||
Total revenue | $ 2,800 | ||
Concentration risk, percentage | 94% | ||
Customer Concentration Risk | Sales Revenue | Five Customers | |||
Concentration risk, financial liabilities | |||
Number of major customers | customer | 5 | ||
Customer Concentration Risk | Sales Revenue | Four Customers | |||
Concentration risk, financial liabilities | |||
Number of major customers | customer | 4 | ||
Concentration risk, percentage | 86% | ||
Customer Concentration Risk | Accounts Receivable | Customer One | |||
Concentration risk, financial liabilities | |||
Concentration risk, percentage | 6% | ||
Customer Concentration Risk | Accounts Receivable | Customer Two | |||
Concentration risk, financial liabilities | |||
Concentration risk, percentage | 30% | ||
Customer Concentration Risk | Accounts Receivable | Customer Three | |||
Concentration risk, financial liabilities | |||
Concentration risk, percentage | 30% | ||
Customer Concentration Risk | Accounts Receivable | Customer Four | |||
Concentration risk, financial liabilities | |||
Concentration risk, percentage | 29% | ||
Customer Concentration Risk | Accounts Receivable | Customer Five | |||
Concentration risk, financial liabilities | |||
Concentration risk, percentage | 0% | ||
Customer Concentration Risk | Accounts Receivable | Five Customers | |||
Concentration risk, financial liabilities | |||
Number of major customers | customer | 5 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Co-Payment Assistance (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Accounts Receivable, Allowance for Credit Loss [Roll Forward] | ||
Beginning balance | $ 5,326 | $ 1,040 |
Allowances for current period sales | 29,541 | 10,325 |
Payments and credits | (23,661) | (6,039) |
Ending balance | 11,206 | 5,326 |
Customer credits, discounts And allowances | ||
Accounts Receivable, Allowance for Credit Loss [Roll Forward] | ||
Beginning balance | 2,994 | 371 |
Allowances for current period sales | 18,385 | 5,891 |
Payments and credits | (16,665) | (3,268) |
Ending balance | 4,714 | 2,994 |
Rebates and co-pay assistance | ||
Accounts Receivable, Allowance for Credit Loss [Roll Forward] | ||
Beginning balance | 1,989 | 528 |
Allowances for current period sales | 8,192 | 4,035 |
Payments and credits | (5,564) | (2,574) |
Ending balance | 4,617 | 1,989 |
Product returns | ||
Accounts Receivable, Allowance for Credit Loss [Roll Forward] | ||
Beginning balance | 343 | 141 |
Allowances for current period sales | 2,964 | 399 |
Payments and credits | (1,432) | (197) |
Ending balance | $ 1,875 | $ 343 |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Warrants (Details) - shares | Dec. 31, 2023 | Dec. 03, 2023 | May 31, 2023 | Jul. 31, 2022 | Apr. 30, 2022 | Mar. 31, 2022 | Oct. 31, 2021 | Feb. 28, 2021 | Feb. 26, 2021 | Feb. 29, 2020 | Feb. 10, 2020 |
Warrants | |||||||||||
Common stock that can be purchased with warrants (in shares) | 4,243 | ||||||||||
Common stock that can be purchased with warrants (in shares) | 24,856 | 6,660 | |||||||||
Public offering | |||||||||||
Warrants | |||||||||||
Common stock that can be purchased with warrants (in shares) | 3,792,572 | 1,093,333 | |||||||||
Common stock that can be purchased with warrants (in shares) | 6,660 | ||||||||||
Common stock warrants | Public offering | |||||||||||
Warrants | |||||||||||
Common stock that can be purchased with warrants (in shares) | 533,333 | ||||||||||
Warrants | |||||||||||
Warrants | |||||||||||
Common stock that can be purchased with warrants (in shares) | 3,800,000 | 3,800,000 | |||||||||
Additional New Warrants | |||||||||||
Warrants | |||||||||||
Common stock that can be purchased with warrants (in shares) | 1,005,560 | ||||||||||
Perceptive Credit Agreement | Warrants | |||||||||||
Warrants | |||||||||||
Common stock that can be purchased with warrants (in shares) | 225 | 225 | 225 | 225 | |||||||
Perceptive Credit Agreement | Perceptive Warrants | |||||||||||
Warrants | |||||||||||
Common stock that can be purchased with warrants (in shares) | 225 | 700 | |||||||||
Common stock that can be purchased with warrants (in shares) | 225 | 700 |
Summary of Significant Accou_11
Summary of Significant Accounting Policies - Income Taxes (Details) $ in Millions | Dec. 31, 2023 USD ($) |
Uncertainty in tax positions | |
Uncertain tax positions | $ 0 |
Summary of Significant Accou_12
Summary of Significant Accounting Policies - Segment Information (Details) | 12 Months Ended |
Dec. 31, 2023 segment | |
Segment Information | |
Number of operating segments | 1 |
Number of reporting segments | 1 |
Summary of Significant Accou_13
Summary of Significant Accounting Policies - Net Loss Per Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Anti-dilutive securities | |||
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 5,806,197 | 1,138,111 | 12,941 |
Common stock warrants | |||
Anti-dilutive securities | |||
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 5,589,637 | 1,130,025 | 7,592 |
Unvested restricted stock units | |||
Anti-dilutive securities | |||
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 173,517 | 129 | 167 |
Common stock options | |||
Anti-dilutive securities | |||
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 43,043 | 7,956 | 5,183 |
Fair Value Measurements - Finan
Fair Value Measurements - Financial Instruments Measured at Fair Value by Hierarchy Level (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Liabilities: | ||
Warrant liability | $ 5,696 | $ 5,934 |
Recurring | Level 1 | ||
Assets: | ||
Cash and cash equivalents | 2,557 | 5,246 |
Total assets at fair value | 2,557 | 5,246 |
Recurring | Level 3 | ||
Liabilities: | ||
Warrant liability | 5,696 | 5,934 |
Total liabilities at fair value | $ 5,696 | $ 5,934 |
Fair Value Measurements - Warra
Fair Value Measurements - Warrant Valuation Assumptions (Details) - Option pricing model | Dec. 31, 2023 USD ($) Y | Dec. 31, 2022 Y USD ($) |
Fair value | ||
Significant assumptions used in valuation of the Company's warrants | ||
Warrants, Measurement Input | 1.95 | 11.50 |
Preferred Warrants [Member] | Strike price | ||
Significant assumptions used in valuation of the Company's warrants | ||
Warrants, Measurement Input | 520 | |
Maximum | Option Volatility | ||
Significant assumptions used in valuation of the Company's warrants | ||
Warrants, Measurement Input | 126 | 137.4 |
Maximum | Risk free interest rate | ||
Significant assumptions used in valuation of the Company's warrants | ||
Warrants, Measurement Input | 4 | 4.7 |
Maximum | Strike price | ||
Significant assumptions used in valuation of the Company's warrants | ||
Warrants, Measurement Input | 1,700 | |
Maximum | Expected life | ||
Significant assumptions used in valuation of the Company's warrants | ||
Warrants, Measurement Input | Y | 4.4 | 4.5 |
Maximum | Common stock warrants | Strike price | ||
Significant assumptions used in valuation of the Company's warrants | ||
Warrants, Measurement Input | 1,700 | |
Minimum | Option Volatility | ||
Significant assumptions used in valuation of the Company's warrants | ||
Warrants, Measurement Input | 101.5 | 136.8 |
Minimum | Risk free interest rate | ||
Significant assumptions used in valuation of the Company's warrants | ||
Warrants, Measurement Input | 3.8 | 4.2 |
Minimum | Strike price | ||
Significant assumptions used in valuation of the Company's warrants | ||
Warrants, Measurement Input | 45 | |
Minimum | Expected life | ||
Significant assumptions used in valuation of the Company's warrants | ||
Warrants, Measurement Input | Y | 2.8 | 0.7 |
Minimum | Common stock warrants | Strike price | ||
Significant assumptions used in valuation of the Company's warrants | ||
Warrants, Measurement Input | 3.69 |
Fair Value Measurements - Level
Fair Value Measurements - Level 3 Warrants (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Transfers between fair value levels | $ 0 | $ 0 |
Warrants | ||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | ||
Beginning balance | 5,934 | |
Warrants issued | 12,537 | |
Change in fair value | (12,775) | |
Ending balance | $ 5,696 | $ 5,934 |
Prepaid Expenses (Details)
Prepaid Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Prepaid Expenses | ||
Prepaid insurance | $ 441 | $ 628 |
Other | 402 | 775 |
Total prepaid expenses and other current assets | $ 843 | $ 1,403 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Property and Equipment | ||
Property and equipment, gross | $ 253 | $ 253 |
Less: accumulated depreciation | (178) | (76) |
Property and equipment, net | 75 | 177 |
Office equipment | ||
Property and Equipment | ||
Property and equipment, gross | $ 132 | $ 132 |
Estimated Life (in years) | 5 years | 5 years |
Computer equipment | ||
Property and Equipment | ||
Property and equipment, gross | $ 121 | $ 121 |
Estimated Life (in years) | 3 years | 3 years |
Manufacturing equipment | ||
Property and Equipment | ||
Estimated Life (in years) | 7 years | 7 years |
Accrued Liabilities (Details)
Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Accrued Liabilities | ||
Gross to net accruals | $ 6,492 | $ 2,332 |
Accrued compensation | 832 | 833 |
Accrued professional fees and other | 1,807 | 743 |
Total accrued liabilities | $ 9,131 | $ 3,908 |
Leases - Summary (Details)
Leases - Summary (Details) | 12 Months Ended | ||
Dec. 31, 2023 USD ($) item | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Leases | |||
Number of finance leases | item | 0 | ||
Number of operating leases | item | 1 | ||
Lessee, Operating Lease, Existence of Option to Extend [true false] | true | ||
Renewal term | 5 years | ||
Operating lease expense | $ | $ 355,000 | $ 355,000 | $ 180,000 |
Operating lease expense information: | |||
Cash paid for amounts included in measurement of lease liabilities | $ | $ 319,000 | $ 175,000 | $ 131,000 |
Weighted-average remaining lease term (years) | 1 year 3 months | ||
Weighted-average discount rate | 11.80% |
Leases - Maturity of lease liab
Leases - Maturity of lease liabilities (Details) $ in Thousands | Dec. 31, 2023 USD ($) |
Operating Leases | |
2024 | $ 397 |
2025 | 101 |
Total | 498 |
Less: Interest | (32) |
Present value of lease liability | $ 466 |
Credit Agreement and Guaranty_2
Credit Agreement and Guaranty (Details) | 1 Months Ended | 2 Months Ended | 3 Months Ended | 4 Months Ended | 12 Months Ended | ||||||||||||||
Mar. 11, 2024 USD ($) | Feb. 22, 2024 USD ($) $ / shares | Feb. 09, 2024 USD ($) | Jul. 25, 2022 USD ($) | Jul. 08, 2022 USD ($) | Jan. 07, 2022 USD ($) | Feb. 10, 2020 USD ($) $ / shares Y item shares | Feb. 10, 2024 USD ($) | Dec. 31, 2023 USD ($) Y $ / shares | Sep. 30, 2023 USD ($) | Oct. 31, 2023 USD ($) | Dec. 31, 2023 USD ($) Y $ / shares | Dec. 31, 2022 USD ($) Y | Oct. 30, 2023 USD ($) | May 31, 2023 $ / shares shares | Jul. 31, 2022 $ / shares shares | Mar. 31, 2022 $ / shares shares | Oct. 31, 2021 $ / shares shares | Feb. 26, 2021 $ / shares shares | |
Credit Agreement and Guaranty | |||||||||||||||||||
Repayments of debt | $ 975,000 | $ 17,375,000 | |||||||||||||||||
Interest rate (as a percent) | 15.60% | 15.60% | |||||||||||||||||
Percentage of annual interest rate | 3% | ||||||||||||||||||
Common stock that can be purchased with warrants (in shares) | shares | 24,856 | 6,660 | |||||||||||||||||
Proceeds from warrant exercises | $ 20,000,000 | ||||||||||||||||||
Perceptive Credit Agreement | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Repayments of debt | $ 5,000,000 | $ 5,000,000 | |||||||||||||||||
Principal payments on its outstanding | $ 150,000 | ||||||||||||||||||
Prepayment of outstanding principal | $ 7,000,000 | ||||||||||||||||||
Variable interest rate margin (as a percent) | 10.25% | ||||||||||||||||||
Perceptive Credit Agreement | Perceptive Warrants | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 5,740 | ||||||||||||||||||
Common stock that can be purchased with warrants (in shares) | shares | 700 | 225 | |||||||||||||||||
Number of warrants issued | item | 2 | ||||||||||||||||||
Facility fee percentage | 1% | ||||||||||||||||||
Perceptive Credit Agreement | First Seven Lakhs Shares | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 7,480 | $ 3.69 | $ 618.50 | $ 4,330.50 | $ 5,760 | ||||||||||||||
Common stock that can be purchased with warrants (in shares) | shares | 350 | 350 | 350 | 350 | 350 | ||||||||||||||
Perceptive Credit Agreement | Remaining Seven Lakhs Shares | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 9,340 | $ 3.69 | $ 745 | $ 5,276 | $ 7,080 | ||||||||||||||
Common stock that can be purchased with warrants (in shares) | shares | 350 | 350 | 350 | 350 | 350 | ||||||||||||||
Perceptive Credit Agreement | Warrants | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 3.69 | $ 501.50 | $ 3,456.50 | $ 4,540 | $ 5,740 | ||||||||||||||
Common stock that can be purchased with warrants (in shares) | shares | 225 | 225 | 225 | 225 | |||||||||||||||
Senior secured delayed draw term loan facility | Perceptive Credit Agreement | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Maximum borrowing capacity | $ 35,000,000 | ||||||||||||||||||
Senior secured delayed draw term loan facility | Perceptive Credit Agreement, Tranche One | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Amount borrowed | 5,000,000 | ||||||||||||||||||
Senior secured delayed draw term loan facility | Perceptive Credit Agreement, Tranche Two | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Amount borrowed | $ 15,000,000 | ||||||||||||||||||
Subsequent Event | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 1.25 | ||||||||||||||||||
Proceeds from warrant exercises | $ 4,800,000 | ||||||||||||||||||
Subsequent Event | Perceptive Credit Agreement | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Repayments of debt | $ 1,350,000 | ||||||||||||||||||
Monthly principal payments | $ 150,000 | ||||||||||||||||||
Prepayment Occur on or Before February, 10, 2024 | Perceptive Credit Agreement | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Prepayment premium percentage | 2% | ||||||||||||||||||
Minimum cash covenants | $ 3,000,000 | $ 1,000,000 | $ 500,000 | ||||||||||||||||
Revenue generated under debt | $ 5,000,000 | ||||||||||||||||||
Two Thousand Twenty Perceptive Warrants [Member] | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Fair value of warrants | $ 3,600,000 | ||||||||||||||||||
Two Thousand Twenty One Perceptive Warrants [Member] | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Beneficial ownership percentage | 19.99% | ||||||||||||||||||
Fair value of warrants | $ 1,100,000 | ||||||||||||||||||
Two Thousand Twenty One Perceptive Warrants Sixth Amendment [Member] | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 10.50 | $ 10.50 | |||||||||||||||||
Two Thousand Twenty One Perceptive Warrants Seventh Amendment [Member] | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 1.82 | $ 1.82 | |||||||||||||||||
Option pricing model | Fair value | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Warrants, Measurement Input | 1.95 | 1.95 | 11.50 | ||||||||||||||||
Option pricing model | Maximum | Risk free interest rate | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Warrants, Measurement Input | 4 | 4 | 4.7 | ||||||||||||||||
Option pricing model | Maximum | Expected life | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Warrants, Measurement Input | Y | 4.4 | 4.4 | 4.5 | ||||||||||||||||
Option pricing model | Maximum | Strike price | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Warrants, Measurement Input | 1,700 | ||||||||||||||||||
Option pricing model | Minimum | Risk free interest rate | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Warrants, Measurement Input | 3.8 | 3.8 | 4.2 | ||||||||||||||||
Option pricing model | Minimum | Expected life | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Warrants, Measurement Input | Y | 2.8 | 2.8 | 0.7 | ||||||||||||||||
Option pricing model | Minimum | Strike price | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Warrants, Measurement Input | 45 | ||||||||||||||||||
Option pricing model | Common stock warrants | Maximum | Strike price | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Warrants, Measurement Input | 1,700 | 1,700 | |||||||||||||||||
Option pricing model | Common stock warrants | Minimum | Strike price | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Warrants, Measurement Input | 3.69 | 3.69 | |||||||||||||||||
Option pricing model | Two Thousand Twenty Perceptive Warrants [Member] | Perceptive Warrants | Volatility | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Warrants, Measurement Input | 0.700 | ||||||||||||||||||
Option pricing model | Two Thousand Twenty Perceptive Warrants [Member] | Perceptive Warrants | Risk free interest rate | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Warrants, Measurement Input | 0.0147 | ||||||||||||||||||
Option pricing model | Two Thousand Twenty Perceptive Warrants [Member] | Perceptive Warrants | Expected life | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Warrants, Measurement Input | Y | 7 | ||||||||||||||||||
Option pricing model | Two Thousand Twenty Perceptive Warrants [Member] | Perceptive Warrants | Fair value | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Warrants, Measurement Input | $ / shares | 8,020 | ||||||||||||||||||
Option pricing model | Two Thousand Twenty Perceptive Warrants [Member] | Maximum | Perceptive Warrants | Strike price | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Warrants, Measurement Input | $ / shares | 9,340 | ||||||||||||||||||
Option pricing model | Two Thousand Twenty Perceptive Warrants [Member] | Minimum | Perceptive Warrants | Strike price | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Warrants, Measurement Input | $ / shares | 7,480 | ||||||||||||||||||
Option pricing model | Two Thousand Twenty One Perceptive Warrants [Member] | Perceptive Warrants | Volatility | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Warrants, Measurement Input | 1.035 | ||||||||||||||||||
Option pricing model | Two Thousand Twenty One Perceptive Warrants [Member] | Perceptive Warrants | Risk free interest rate | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Warrants, Measurement Input | 0.0115 | ||||||||||||||||||
Option pricing model | Two Thousand Twenty One Perceptive Warrants [Member] | Perceptive Warrants | Expected life | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Warrants, Measurement Input | Y | 7 | ||||||||||||||||||
Option pricing model | Two Thousand Twenty One Perceptive Warrants [Member] | Perceptive Warrants | Strike price | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Warrants, Measurement Input | $ / shares | 5,740 | ||||||||||||||||||
Option pricing model | Two Thousand Twenty One Perceptive Warrants [Member] | Perceptive Warrants | Fair value | |||||||||||||||||||
Credit Agreement and Guaranty | |||||||||||||||||||
Warrants, Measurement Input | $ / shares | 5,740 |
Credit Agreement and Guaranty -
Credit Agreement and Guaranty - Carrying Amount Of term Loan (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Credit Agreement and Guaranty | |||
Long-term debt | $ 1,650,000 | $ 2,625,000 | |
Debt issuance costs | (23,000) | (209,000) | |
Warrant discount | (112,000) | (990,000) | |
Total debt | 1,515,000 | 1,426,000 | |
Less, current portion | 1,515,000 | 1,426,000 | |
Amortization and debt issue costs | $ 1,063,000 | $ 1,969,000 | $ 1,661,000 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) - Amended and Restated Certificate of Incorporation (Details) | Apr. 10, 2023 shares | Dec. 31, 2023 shares | Apr. 09, 2023 shares | Dec. 31, 2022 shares | Jan. 07, 2022 shares | Jan. 06, 2022 shares |
Stockholders' Equity (Deficit) | ||||||
Common stock, authorized (in shares) | 300,000,000 | 300,000,000 | 300,000,000 | 150,000,000 | ||
Reverse stock split conversion ratio | 0.02 | |||||
Common stock, issued (in shares) | 932,101 | 2,963,657 | 46,605,134 | 859,402 | ||
Common Stock, Shares, Outstanding | 932,101 | 2,963,657 | 46,605,134 | 859,402 |
Stockholders' Equity (Deficit_2
Stockholders' Equity (Deficit) - Common Stock (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | 5 Months Ended | 12 Months Ended | ||||||||||||||||
Aug. 22, 2022 | Apr. 27, 2022 | Apr. 25, 2022 | Apr. 04, 2022 | Mar. 15, 2022 | Mar. 14, 2022 | Jan. 10, 2022 | May 31, 2023 | Jul. 31, 2022 | Oct. 31, 2021 | Mar. 31, 2021 | Mar. 31, 2022 | Sep. 30, 2022 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Feb. 22, 2024 | Dec. 03, 2023 | Apr. 12, 2023 | Oct. 02, 2020 | |
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Common stock that can be purchased with warrants (in shares) | 6,660 | 24,856 | ||||||||||||||||||
Stock stated value | $ 0.0001 | $ 0.0001 | ||||||||||||||||||
Subsequent Event | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 1.25 | |||||||||||||||||||
Maximum | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 75 | |||||||||||||||||||
Common stock | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Stock Issued During Period, Shares, Warrants Exercised | 1,801,286 | |||||||||||||||||||
Conversion of stock shares converted | 6,063 | |||||||||||||||||||
Conversion of convertible preferred stock (in shares) | 6,063 | |||||||||||||||||||
Series B Warrants | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Warrants and rights outstanding, term | 5 years | |||||||||||||||||||
Warrants | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Common stock that can be purchased with warrants (in shares) | 3,800,000 | 3,800,000 | ||||||||||||||||||
Additional New Warrants | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Common stock that can be purchased with warrants (in shares) | 1,005,560 | |||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 2.09 | |||||||||||||||||||
2020 Shelf Registration Statement | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Aggregate amount of securities issuable | $ 200 | |||||||||||||||||||
2022 Preferred Stock Offering | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Common stock that can be purchased with warrants (in shares) | 606 | |||||||||||||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 4.1 | |||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 500 | |||||||||||||||||||
Conversion price | $ 400 | |||||||||||||||||||
Preferred Stock, convertible, shares issuable | 12,125 | |||||||||||||||||||
Exercisable term | 6 months | |||||||||||||||||||
Stock stated value | $ 1,000 | |||||||||||||||||||
Duration From Offering To Anniversary Of Closing | 180 days | |||||||||||||||||||
2022 Preferred Stock Offering | Series A Warrants | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Common stock that can be purchased with warrants (in shares) | 4,243 | 12,125 | ||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 520 | |||||||||||||||||||
Exercisable term | 6 months | |||||||||||||||||||
Warrants and rights outstanding, term | 5 years | |||||||||||||||||||
Warrant Exercisable Term | 5 years | |||||||||||||||||||
2022 Preferred Stock Offering | Series B Warrants | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Common stock that can be purchased with warrants (in shares) | 12,125 | |||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 520 | |||||||||||||||||||
Exercisable term | 6 months | |||||||||||||||||||
Warrants and rights outstanding, term | 1 year 6 months | |||||||||||||||||||
At-the-market sales | Common stock | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Issuance of common stock (in shares) | 207,883 | 253,115 | 3,458 | |||||||||||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 9.3 | |||||||||||||||||||
At-the-market sales | Common stock | Maximum | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Commission percentage | 3% | 3% | ||||||||||||||||||
Authorized value for shares issuance | $ 12.8 | $ 50 | ||||||||||||||||||
Public offering | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Issuance of common stock (in shares) | 3,792,572 | 150,367 | ||||||||||||||||||
Common stock that can be purchased with warrants (in shares) | 6,660 | |||||||||||||||||||
Share price (in dollars per share) | $ 3.9551 | $ 45 | ||||||||||||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 22 | |||||||||||||||||||
Public offering | Common stock | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Issuance of common stock (in shares) | 95,000 | 382,966 | 13,333 | 95,000 | 533,333 | 13,333 | ||||||||||||||
Common stock that can be purchased with one-half of warrant (in shares) | 1 | |||||||||||||||||||
Share price (in dollars per share) | $ 1,700 | |||||||||||||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 6.5 | $ 21.1 | ||||||||||||||||||
Public offering | Series A-1 warrants | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Warrant Exercisable Term | 5 years | |||||||||||||||||||
Public offering | Pre-funded warrants | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Common stock that can be purchased with warrants (in shares) | 1,801,286 | |||||||||||||||||||
Class of Warrant or Right, Exercisable | 1,801,286 | |||||||||||||||||||
Public offering | Series B Pre-funded Warrants | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Common stock that can be purchased with warrants (in shares) | 150,366 | |||||||||||||||||||
2022 ATM | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Issuance of common stock (in shares) | 173,750 | 207,883 | 78,853 | |||||||||||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 12.2 | $ 1.7 | $ 0.9 | |||||||||||||||||
Eligible Amount Authorized To Sell | $ 4.5 | |||||||||||||||||||
2022 ATM | Common stock | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Issuance of common stock (in shares) | 512 | |||||||||||||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 0.3 | |||||||||||||||||||
2022 ATM | Common stock | Maximum | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Commission percentage | 3% | |||||||||||||||||||
Authorized value for shares issuance | $ 50 | |||||||||||||||||||
2022 ATM | New Warrant [Member] | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Warrant Exercisable Term | 6 months | |||||||||||||||||||
H.C. Wainwright & Co., LLC, Sales Agent [Member] | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Common stock that can be purchased with warrants (in shares) | 94,814 | 26,666 | ||||||||||||||||||
Commission percentage | 7% | 7% | ||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 4.9439 | $ 56.25 | ||||||||||||||||||
Series A Preferred Stock | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Conversion of stock shares converted | 2,425 | |||||||||||||||||||
Series A Preferred Stock | 2022 Preferred Stock Offering | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Issuance of common stock (in shares) | 2,425 | |||||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 520 | |||||||||||||||||||
Series B Preferred Stock | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Issuance of common stock (in shares) | 2,425 | |||||||||||||||||||
Series B Preferred Stock | 2022 Preferred Stock Offering | ||||||||||||||||||||
Stockholders' Equity (Deficit) | ||||||||||||||||||||
Issuance of common stock (in shares) | 2,425 |
Equity Incentive Plans - Stock
Equity Incentive Plans - Stock Options Summary (Details) - Common stock options | 12 Months Ended |
Dec. 31, 2023 $ / shares shares | |
Minimum | |
Equity Incentive Plans | |
Exercise prices of options granted through the end of the year (in dollars per share) | $ 10 |
Maximum | |
Equity Incentive Plans | |
Exercise prices of options granted through the end of the year (in dollars per share) | $ 21,500 |
1997 Plan and 2008 Plan | |
Equity Incentive Plans | |
Expiration period | 10 years |
Vesting period | 4 years |
2014 Incentive Compensation Plan | |
Equity Incentive Plans | |
Shares available for grant | shares | 6,200 |
Equity Incentive Plans - Stock-
Equity Incentive Plans - Stock-Based Compensation (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Equity Incentive Plans | |||
Total stock-based compensation expense | $ 1,981 | $ 2,493 | $ 3,338 |
Common stock options | |||
Equity Incentive Plans | |||
Total stock-based compensation expense | $ 1,981 | $ 2,492 | $ 3,338 |
Assumptions used to compute employee stock based compensation under the Black-Scholes option pricing model | |||
Expected dividend yield (as a percent) | 0% | 0% | 0% |
Expected life (in years) | 6 years 3 months | 6 years 3 months | 6 years 3 months |
Unrecorded deferred stock-based compensation | |||
Unrecorded deferred stock-based compensation balance related to stock options | $ 1,400 | ||
Weighted-average amortization period over which cost is expected to be recognized | 2 years 9 months 18 days | ||
Weighted average grant date fair value of options granted (in dollars per share) | $ 2.64 | ||
Common stock options | Cost of product revenues | |||
Equity Incentive Plans | |||
Total stock-based compensation expense | $ 107 | $ 133 | $ 271 |
Common stock options | Research and development | |||
Equity Incentive Plans | |||
Total stock-based compensation expense | 358 | 372 | 490 |
Common stock options | Selling and marketing | |||
Equity Incentive Plans | |||
Total stock-based compensation expense | 102 | 155 | 148 |
Common stock options | General and administrative | |||
Equity Incentive Plans | |||
Total stock-based compensation expense | $ 1,414 | $ 1,832 | $ 2,429 |
Common stock options | Minimum | |||
Assumptions used to compute employee stock based compensation under the Black-Scholes option pricing model | |||
Risk-free interest rate (as a percent) | 3.87% | 1.71% | 0.66% |
Expected volatility (as a percent) | 115.90% | 107% | 105% |
Common stock options | Maximum | |||
Assumptions used to compute employee stock based compensation under the Black-Scholes option pricing model | |||
Risk-free interest rate (as a percent) | 3.90% | 4.22% | 1.51% |
Expected volatility (as a percent) | 118.60% | 118% | 106% |
Unvested restricted stock units | |||
Unrecorded deferred stock-based compensation | |||
Unrecorded deferred stock-based compensation balance related to stock options | $ 300 | ||
Weighted-average amortization period over which cost is expected to be recognized | 3 years 1 month 9 days |
Equity Incentive Plans - Stoc_2
Equity Incentive Plans - Stock Option Activity (Details) - Common stock options - $ / shares | 12 Months Ended | |||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 29, 2023 | |
Options | ||||
Options outstanding at beginning of year (in shares) | 7,928 | 5,183 | ||
Options granted (in shares) | 35,825 | 3,749 | ||
Options exercised (in shares) | 0 | |||
Options cancelled/forfeited (in shares) | (710) | (1,004) | ||
Options outstanding at end of year (in shares) | 43,043 | 7,928 | 5,183 | |
Options exercisable at end of year (in shares) | 5,007 | |||
Vested and expected to vest at end of year (in shares) | 43,043 | |||
Weighted Average Exercise Price | ||||
Options outstanding at beginning of year (in dollars per share) | $ 3,187.50 | $ 5,666.50 | ||
Options granted (in dollars per share) | 2.64 | 198.50 | ||
Options exercised (in dollars per share) | 0 | |||
Options cancelled/forfeited (in dollars per share) | 2,398.42 | 4,872 | ||
Options outstanding at end of year (in dollars per share) | 548.70 | $ 3,187.50 | $ 5,666.50 | |
Options exercisable at end of year (in dollars per share) | $ 4,438.73 | |||
Weighted Average Remaining Contractual Life (Years) | ||||
Options outstanding | 9 years | 7 years 8 months 12 days | 6 years 1 month 6 days | |
Options exercisable | 5 years 9 months 18 days | |||
Estimated stock price (in dollars per share) | $ 1.95 |
Equity Incentive Plans - Restri
Equity Incentive Plans - Restricted Stock (Details) - Unvested restricted stock units - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Shares | |||
Restricted stock outstanding at beginning of year (in shares) | 125 | 167 | |
Granted (in shares) | 155,004 | 94 | |
Vested (in shares) | (112) | (135) | |
Forfeited (in shares) | (1,500) | ||
Restricted stock outstanding at end of year (in shares) | 153,517 | 125 | 167 |
Weighted Average Grant Date Fair Value | |||
Granted (in dollars per share) | $ 2.46 | $ 52.50 | |
Vested (in dollars per share) | 674.63 | $ 3,815 | |
Forfeited (in dollars per share) | $ 2.48 | ||
Aggregate Intrinsic Value | |||
Intrinsic value of vested shares | $ 299 | $ 163 | $ 163 |
Executive officers | |||
Shares | |||
Granted (in shares) | 35 | ||
Vesting period | 1 year | ||
Directors | |||
Shares | |||
Granted (in shares) | 94 | 113 | |
Directors | Minimum | |||
Shares | |||
Vesting period | 1 year | 1 year | |
Directors | Maximum | |||
Shares | |||
Vesting period | 3 years | ||
Employees and directors | |||
Shares | |||
Granted (in shares) | 155,004 | ||
Employees and directors | Minimum | |||
Shares | |||
Vesting period | 1 year | ||
Employees and directors | Maximum | |||
Shares | |||
Vesting period | 4 years |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2018 | |
Federal | Net Operating Losses | ||
Income Taxes | ||
Net operating loss carryforwards | $ 396.5 | $ 186.9 |
Indefinite net operating loss carryforward | 209.6 | |
Federal | Research and Development. | ||
Income Taxes | ||
Tax credit carryforwards | 6.3 | |
State | Net Operating Losses | ||
Income Taxes | ||
Net operating loss carryforwards | 77.4 | |
State | Research and Development. | ||
Income Taxes | ||
Tax credit carryforwards | $ 0.9 |
Income Taxes - Deferred Taxes (
Income Taxes - Deferred Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 88,279 | $ 87,216 |
Research credit carryforward | 7,026 | 7,071 |
Capitalized research and development expenses | 164 | 205 |
Stock options and other | 5,028 | 2,092 |
Total gross deferred tax assets | 100,497 | 96,584 |
Valuation allowance for deferred tax assets | (100,497) | (96,584) |
Net deferred tax assets | 0 | 0 |
Valuation allowance | ||
Increase (decrease) in the valuation allowance | $ 3,900 | $ 5,400 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of U.S. statutory income tax rate to effective tax rate (Details) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Reconciliation of the U.S. statutory income tax rate to the Company's effective tax rate | |||
Federal income tax at statutory rate (as a percent) | 21% | 21% | 21% |
State income tax benefit, net of federal benefit (as a percent) | 0.90% | 0.10% | 0.20% |
Unrealized gain on warrants | 9.80% | 17.80% | 1.10% |
Research and development tax credits (as a percent) | 0.10% | 0.20% | |
Other (as a percent) | (4.60%) | (5.50%) | (2.20%) |
Increase to valuation allowance (as a percent) | (27.10%) | (18.00%) | (20.30%) |
Effective income tax rate (as a percent) | 0% | 15.50% | 0% |
Income Taxes - Sale of New Jers
Income Taxes - Sale of New Jersey Net Operating Losses (Details) - New Jersey - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | ||
Jan. 31, 2021 | Jan. 31, 2018 | Dec. 31, 2022 | Mar. 31, 2022 | |
Sale of New Jersey Net Operating Losses | ||||
Net proceeds from sale of NOL and tax credit | $ 4.7 | |||
Sale of unused NOLs | ||||
Sale of New Jersey Net Operating Losses | ||||
Maximum lifetime benefit under the Program | $ 20 | $ 15 | ||
Sale of unused NOLs | Minimum | ||||
Sale of New Jersey Net Operating Losses | ||||
Allowable sale of unused tax benefits as a percentage of total value | 80% | |||
Net Operating Losses | ||||
Sale of New Jersey Net Operating Losses | ||||
NOLs | $ 44.3 | |||
Research and Development. | ||||
Sale of New Jersey Net Operating Losses | ||||
NOLs | $ 1 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | |
Apr. 30, 2020 | Dec. 31, 2022 | Dec. 31, 2023 | |
Commitments and Contingencies | |||
Future purchase commitments | $ 227.9 | ||
Corium Agreement [Member] | |||
Commitments and Contingencies | |||
Quarterly minimum volume amount of product to be ordered | $ 5.6 | ||
Additional fee payable as a percentage of transfer price for units ordered | 25% | ||
Percentage of additional fee as penalty percent | 25% | ||
2024 and Each Year Thereafter | $ 22.5 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | 12 Months Ended | |||||||||
Mar. 11, 2024 | Feb. 22, 2024 | Feb. 09, 2024 | Jul. 08, 2022 | Jan. 07, 2022 | Feb. 10, 2020 | Dec. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2022 | Oct. 31, 2021 | |
Subsequent Events | ||||||||||
Proceeds from warrant exercises | $ 20,000,000 | |||||||||
Shares issuable upon exercise of warrants | 24,856 | 6,660 | ||||||||
Repayments | $ 975,000 | $ 17,375,000 | ||||||||
Perceptive Credit Agreement | ||||||||||
Subsequent Events | ||||||||||
Repayments | $ 5,000,000 | $ 5,000,000 | ||||||||
Subsequent event | ||||||||||
Subsequent Events | ||||||||||
Number of warrants agreed to exercise for cash | 3,892,572 | |||||||||
Exercise price of warrants (in dollars per share) | $ 1.25 | |||||||||
Proceeds from warrant exercises | $ 4,800,000 | |||||||||
Subsequent event | Perceptive Credit Agreement | ||||||||||
Subsequent Events | ||||||||||
Monthly paayments on loan | $ 150,000 | |||||||||
Repayments | $ 1,350,000 | |||||||||
Subsequent event | New warrants | ||||||||||
Subsequent Events | ||||||||||
Exercise price of warrants (in dollars per share) | $ 1 | |||||||||
Shares issuable upon exercise of warrants | 7,785,144 | |||||||||
Subsequent event | Warrants with five year term | ||||||||||
Subsequent Events | ||||||||||
Shares issuable upon exercise of warrants | 3,992,572 | |||||||||
Warrants term | 5 years | |||||||||
Subsequent event | Warrants with eighteen months term | ||||||||||
Subsequent Events | ||||||||||
Shares issuable upon exercise of warrants | 3,792,572 | |||||||||
Warrants term | 18 months | |||||||||
Subsequent event | Placement Agent Warrants | ||||||||||
Subsequent Events | ||||||||||
Exercise price of warrants (in dollars per share) | $ 1.5625 | |||||||||
Cash fee percentage | 7% | |||||||||
Management fee percentage | 1% | |||||||||
Stock issuable as a percentage on warrants exercised | 5% |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Pay vs Performance Disclosure | |||
Net Income (Loss) | $ (14,465) | $ (25,412) | $ (71,067) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Modification | false |
Rule 10b5-1 Arrangement Modification | false |