Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 25, 2022 | Jun. 30, 2021 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2021 | ||
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(b) Security | Common stock | ||
Trading Symbol | AGRX | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 101.2 | ||
Entity Common Stock, Shares Outstanding | 134,616,862 | ||
Entity Central Index Key | 0001261249 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2021 | ||
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, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 19,143 | $ 14,463 |
Marketable securities | 0 | 40,008 |
Accounts receivable, net | 1,533 | 865 |
Inventory, net | 966 | |
Prepaid expenses and other current assets | 2,283 | 1,449 |
Total current assets | 23,925 | 56,785 |
Property and equipment, net | 12,447 | 14,243 |
Right of use asset | 949 | 138 |
Other non-current assets | 2,012 | 1,896 |
Total assets | 39,333 | 73,062 |
Current liabilities: | ||
Long-term debt, current portion | 16,833 | |
Accounts payable | 8,707 | 3,867 |
Accrued expenses | 3,563 | 3,348 |
Lease liability, current portion | 175 | 138 |
Total current liabilities | 29,278 | 7,353 |
Lease liability, long-term | 784 | |
Long-term debt | 16,381 | |
Total liabilities | 30,062 | 23,734 |
Commitments and contingencies (Note 11) | ||
Stockholders' equity | ||
Common stock, $.0001 par value, 150,000,000 shares authorized, 121,396,033 and 87,563,753 issued and outstanding at December 31, 2021 and December 31, 2020, respectively | 12 | 9 |
Additional paid-in capital | 396,376 | 361,539 |
Accumulated other comprehensive income | 3 | |
Accumulated deficit | (387,117) | (312,223) |
Total stockholders' equity | 9,271 | 49,328 |
Total liabilities and stockholders' equity | $ 39,333 | $ 73,062 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Balance Sheets | ||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, authorized (in shares) | 150,000,000 | 150,000,000 |
Common stock, issued (in shares) | 121,396,033 | 87,563,753 |
Common stock, outstanding (in shares) | 121,396,033 | 87,563,753 |
Statements of Operations
Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Statements of Operations | |||
Revenues, net | $ 4,101 | $ 749 | |
Cost of product revenues | 10,718 | 282 | |
Gross profit (loss) | (6,617) | 467 | |
Operating expenses: | |||
Research and development | 6,246 | 13,500 | $ 9,858 |
Selling and marketing | 43,444 | 23,285 | 1,085 |
General and administrative | 14,698 | 12,735 | 7,915 |
Total operating expenses | 64,388 | 49,520 | 18,858 |
Loss from operations | (71,005) | (49,053) | (18,858) |
Other income (expense) | |||
Interest income | 25 | 309 | 252 |
Interest expense | (3,914) | (3,109) | |
Total other income (expense), net | (3,889) | (2,800) | 252 |
Net loss | $ (74,894) | $ (51,853) | $ (18,606) |
Net loss per share (basic) (in dollars per share) | $ (0.77) | $ (0.61) | $ (0.38) |
Net loss per share (diluted) (in dollars per share) | $ (0.77) | $ (0.61) | $ (0.38) |
Weighted-average common shares (basic) (in shares) | 97,072,847 | 84,683,084 | 49,432,487 |
Weighted-average common shares (diluted) (in shares) | 97,072,847 | 84,683,084 | 49,432,487 |
Comprehensive loss: | |||
Net loss | $ (74,894) | $ (51,853) | $ (18,606) |
Other comprehensive income: | |||
Unrealized loss on marketable securities | (3) | 3 | |
Comprehensive loss | $ (74,897) | $ (51,850) | $ (18,606) |
Statements of Changes in Stockh
Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Common stockPublic offering | Common stockPrivate Placement | Common stockAt-the-market sales | Common stock | Additional Paid in Capital.Public offering | Additional Paid in Capital.Private Placement | Additional Paid in Capital.At-the-market sales | Additional Paid in Capital.Cumulative Effect, Period of Adoption, Adjusted Balance [Member] | Additional Paid in Capital. | Accumulated Other Comprehensive IncomePublic offering | Accumulated Other Comprehensive Income | Accumulated DeficitCumulative Effect, Period of Adoption, Adjusted Balance [Member] | Accumulated Deficit | Public offering | Private Placement | At-the-market sales | Total |
Balance at Dec. 31, 2018 | $ 3 | $ 261,722 | $ (241,551) | $ 20,174 | |||||||||||||
Balance (in shares) at Dec. 31, 2018 | 34,377,329 | ||||||||||||||||
Increase (decrease) in stockholders' equity | |||||||||||||||||
Share-based compensation - stock options and RSUs | 1,762 | 1,762 | |||||||||||||||
Issuance of common stock | $ 2 | $ 1 | $ 1 | $ 12,685 | $ 7,809 | $ 21,753 | $ 12,687 | $ 7,810 | $ 21,754 | ||||||||
Issuance of common stock (in shares) | 14,526,315 | 8,426,750 | 12,242,436 | ||||||||||||||
Issuance of common stock upon exercise of options | 164 | 164 | |||||||||||||||
Issuance of common stock upon exercise of options (in shares) | 92,271 | ||||||||||||||||
Vesting of RSUs (in shares) | 145,204 | ||||||||||||||||
Net loss | (18,606) | (18,606) | |||||||||||||||
Balance at Dec. 31, 2019 | $ 7 | $ 213 | 306,108 | $ (213) | (260,370) | 45,745 | |||||||||||
Balance (in shares) at Dec. 31, 2019 | 69,810,305 | ||||||||||||||||
Increase (decrease) in stockholders' equity | |||||||||||||||||
Share-based compensation - stock options and RSUs | 2,818 | 2,818 | |||||||||||||||
Issuance of common stock | $ 2 | 48,433 | 48,435 | ||||||||||||||
Issuance of common stock (in shares) | 17,250,000 | ||||||||||||||||
Issuance of common stock upon exercise of options | 610 | 610 | |||||||||||||||
Issuance of common stock upon exercise of options (in shares) | 503,448 | ||||||||||||||||
Warrants issued in connection with long-term debt | 3,570 | 3,570 | |||||||||||||||
Unrealized net gain on marketable securities | $ 3 | 3 | 3 | ||||||||||||||
Net loss | (51,853) | (51,853) | |||||||||||||||
Balance at Dec. 31, 2020 | $ 9 | 361,539 | $ 3 | (312,223) | 49,328 | ||||||||||||
Balance (in shares) at Dec. 31, 2020 | 87,563,753 | ||||||||||||||||
Increase (decrease) in stockholders' equity | |||||||||||||||||
Share-based compensation - stock options and RSUs | 3,338 | 3,338 | |||||||||||||||
Issuance of common stock | $ 3 | $ 21,078 | $ 9,266 | $ 21,081 | $ 9,266 | ||||||||||||
Issuance of common stock (in shares) | 26,666,648 | 6,915,151 | |||||||||||||||
Issuance of common stock upon exercise of options | 75 | 75 | |||||||||||||||
Issuance of common stock upon exercise of options (in shares) | 126,400 | ||||||||||||||||
Vesting of RSUs | (3) | ||||||||||||||||
Vesting of RSUs (in shares) | 124,081 | ||||||||||||||||
Warrants issued in connection with long-term debt | 1,080 | 1,080 | |||||||||||||||
Unrealized net gain on marketable securities | $ (3) | (3) | |||||||||||||||
Net loss | $ 0 | 0 | (74,894) | (74,894) | |||||||||||||
Balance at Dec. 31, 2021 | $ 12 | $ 396,376 | $ (387,117) | $ 9,271 | |||||||||||||
Balance (in shares) at Dec. 31, 2021 | 121,396,033 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Cash flows from operating activities: | |||
Net loss | $ (74,894,000) | $ (51,853,000) | $ (18,606,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Noncash inventory reserve | 5,323,000 | ||
Depreciation | 2,064,000 | 105,000 | 18,000 |
Amortization | 159,000 | 171,000 | 145,000 |
Noncash stock-based compensation | 3,338,000 | 2,818,000 | 1,762,000 |
Noncash interest | 1,661,000 | 1,341,000 | |
Changes in operating assets and liabilities: | |||
Accounts receivable | (668,000) | (865,000) | |
Inventory | (6,289,000) | ||
Prepaid expenses and other assets | (967,000) | (2,485,000) | (233,000) |
Accounts payable and accrued expenses | 5,202,000 | 3,641,000 | 1,377,000 |
Lease liability | (131,000) | (184,000) | (152,000) |
Net cash used in operating activities | (65,202,000) | (47,311,000) | (15,689,000) |
Cash flows from investing activities: | |||
Purchases of marketable securities | (54,837,000) | ||
Sales and maturities of marketable securities | 39,729,000 | 14,500,000 | |
Acquisition of property and equipment | (269,000) | (353,000) | (98,000) |
Net cash provided by (used in) investing activities | 39,460,000 | (40,690,000) | (98,000) |
Cash flows from financing activities: | |||
Proceeds from issuance of common stock in private placement, net of offering costs | 7,810,000 | ||
Proceeds from issuance of long-term debt | 20,000,000 | ||
Debt financing costs paid | (1,059,000) | ||
Proceeds from exercise of stock options | 75,000 | 610,000 | 164,000 |
Net cash provided by financing activities | 30,422,000 | 67,985,000 | 42,415,000 |
Net increase (decrease) in cash and cash equivalents | 4,680,000 | (20,016,000) | 26,628,000 |
Cash and cash equivalents, beginning of period | 14,463,000 | 34,479,000 | 7,851,000 |
Cash and cash equivalents, end of period | 19,143,000 | 14,463,000 | 34,479,000 |
Supplemental disclosure of noncash financing activities | |||
Warrants issued in connection with long-term debt | 1,080,000 | 3,570,000 | |
Operating right-of-use assets obtained in exchange for new operating lease liabilities | 969,000 | ||
Supplemental cash flow information | |||
Interest paid | 2,383,000 | 2,099,000 | |
Non-cash transactions | |||
Property and equipment purchases included in accounts payable | 49,000 | ||
Public offering | |||
Cash flows from financing activities: | |||
Proceeds from issuance of common stock, net of offering costs | 21,081,000 | $ 48,434,000 | 12,687,000 |
At-the-market sales | |||
Cash flows from financing activities: | |||
Proceeds from At-the-Market sales of common stock, net of offering costs | $ 9,266,000 | $ 21,754,000 |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2021 | |
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 and performing research and development, including development of the Company’s lead product, Twirla. The Company is headquartered in Princeton, New Jersey. The Company’s sole approved product, Twirla ® , also known as AG200-15, is a once-weekly prescription contraceptive patch that received approval from the U.S. Food and Drug Administration, or FDA in February 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 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 potential need to obtain additional capital necessary to fund the development of its products, competition from larger companies and compliance with FDA and other government regulations. If the Company does not successfully commercialize any product candidates, 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, 2021, the Company had an accumulated deficit of approximately $387 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 to support the continued commercialization 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 ● adds 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 10), private placements of its convertible preferred stock, venture loans, and non-dilutive grant funding. Going Concern As of December 31, 2021, the Company had cash and cash equivalents of $19.1 million and a $4.9 million working capital deficit. The Company’s current liquidity is sufficient to fund operations only into the second quarter of 2022. 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 at December 31, 2021 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, 2021 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 on its business plan and successfully launch Twirla. The audited financial statements as of December 31, 2021 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, 2021 | |
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, costs of product revenues, 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. It should be noted that current public health threats could adversely affect the Company’s ongoing or planned business operations. In particular, the ongoing COVID-19 pandemic has resulted in federal, state and local governments and private entities mandating various restrictions, including travel restrictions, access restrictions, restrictions on public gatherings, and stay at home orders. The effect of these orders, government imposed quarantines and measures the Company has taken, such as implementing work-at-home policies, may negatively impact productivity, disrupt the Company’s business and could delay the Company’s commercialization timeline. The Company cannot presently predict the scope and severity of any potential business shutdowns or disruptions, but if the Company or any of the third parties with whom it engages, including personnel at third-party manufacturing facilities and other third parties with whom the Company conducts business, were to experience shutdowns or other business disruptions, the Company’s ability to conduct its business in the manner and on the timeline presently planned could be materially and adversely impacted. It is unknown how long these conditions will last and what the complete effect will be on the Company. While to date we have been able to continue to execute our overall business plan, some of our business activities have been slowed and taken longer to complete and we continue to adjust to the challenges of operating in a largely remote setting with our employees. We have only recently launched our commercial activities for Twirla and begun engaging with healthcare providers to promote Twirla. We expect that, as we broaden our sales detailing activities, in some instances our sales force may encounter challenges engaging with healthcare providers during this on-going pandemic. Although many areas of the United States have begun to re-open access to offices and other commercial facilities, there continue to be areas where restrictions remain in place, which may have the potential to affect our ability to conduct our business. Further, new variants, including those which are more easily transmissible or resistant to existing vaccines, may lead to new shutdowns or business disruptions in the future. The Company will continue to closely monitor events as they develop and evaluate alternative, mitigating measures it can implement if needed. 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. Marketable Securities The Company invests a portion of its excess cash balances in marketable securities, including U.S. government agency securities, and highly rated corporate bonds. The Company classifies all of its marketable securities as current assets on the balance sheet because they are available-for-sale and available to fund current operations. Marketable securities are stated at fair value with unrealized gains and losses included as a component of accumulated other comprehensive income (loss), which is a separate component of stockholders' equity, until such gains and losses are realized. If a decline in the fair value is considered other-than-temporary, based on available evidence, the unrealized loss is reclassified from accumulated other comprehensive income (loss) to the statements of operations. Realized gains and losses are determined on the specific identification method and are included in other income. Trade Accounts Receivable and Allowances Trade accounts receivable are amounts owed to the Company by its customers for product that has been delivered. The trade 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 is 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, 2021 and 2020, respectively. Trade 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. During the year ended December 31, 2021, the Company established a reserve of approximately $5.3 million for inventory not expected to be sold prior to its shelf life date. The Company’s third-party manufacturer, Corium, completed the validation of the commercial manufacturing process for Twirla in the fourth quarter of 2020. The costs associated with validation batches were expensed as research and development expenses during the period the costs were incurred. The Company used this validation product for commercial supplies and samples of Twirla into May 2021. Since the Company did not capitalize any validation product, all sales of this validation product had no associated product cost. During the year ended Dectember 31, 2021, units sold with no associated product cost were approximately 3,000 . Had such inventory been valued at acquisition cost, it would have resulted in an immaterial increase to cost of goods sold and a corresponding decrease to gross profit. 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. 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 9) 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 $277,000, $231,000 and $0 for the years ended December 31, 2021, 2020 and 2019, respectively. Concentrations of Credit Risk Financial instruments which potentially subject the Company to credit risk consist principally of cash, cash equivalents and marketable securities. The Company invests its cash, cash equivalents and marketable securities in debt instruments and interest-bearing accounts in United States financial institutions, the balances of which exceed federally insured limits. The Company has not Major customers of the Company are defined as those constituting greater than 10% of its total revenue. In 2021, the Company had sales to customers that individually accounted for more than 10% of our total revenue. These customers had sales of of total revenues in the aggregate. Accounts receivable related to each of these major customers comprised 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. Trade accounts receivable due to the Company from contracts with its customers are stated separately in the balance sheet, net of various allowances as described in the Trade 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 •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 significant 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 relied on industry standard data and trend analysis since historical sales data was not available as Twirla was launched in December 2020. As historical data becomes available, the Company will incorporate that data into its estimates of 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 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 trade 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 December 31, Allowances for Payments & December 31, 2020 current period sales credits 2021 Customer credits, discounts and allowances $ 187 $ 825 $ (641) $ 371 Rebates and co-pay assistance 116 1,055 (502) 669 Total $ 303 $ 1,880 $ (1,143) $ 1,040 Warrants The Company accounts for its warrants to purchase common stock in accordance with ASC 480, Distinguishing Liabilities from Equity . On January 1, 2019, the Company adopted the provisions of Accounting Standards Update (“ASU”) 2017-11 Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (Part I) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Non-controlling Interests with a Scope Exception, In connection with entering into a senior secured term loan facility in February 2020, the Company issued warrants to purchase 1,400,000 shares of its common stock. In connection with an amendment to that facility in February 2021, the Company issued a warrant to purchase 450,000 shares of the Company’s common stock. In connection with an underwritten public offering completed in October 2021, the Company issued warrants to purchase 13,333,324 shares of its common stock. This offering also triggered an adjustment to the exercise price of the existing warrants mentioned above, which resulted in a reduction of the strike price for these warrants. This reduction resulted in an immaterial increase to additional paid in capital. S 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 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. Cost associated with performance-based restricted stock units with a performance condition which affects the vesting is recognized only if the performance condition is probable of being satisfied. 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 segment, which is the business of commercializing its transdermal patch for use in contraception. 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, 2021, 2020 and 2019, respectively, because to do so would be anti-dilutive (in common equivalent shares): Year Ended December 31, 2021 2020 2019 Common stock warrants 15,183,324 1,400,000 180,274 Unvested restricted stock units 333,290 159,795 — Common stock options 10,367,442 8,519,086 7,192,357 Total 25,884,056 10,078,881 7,372,631 Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe that the adoption of recently issued standards have or may have a material impact on our consolidated financial statements or disclosures. In July 2017, the FASB issued ASU No. 2017-11, Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (Part 1) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception. additional paid-in capital. As a result of the adoption of ASU 2017-11, effective January 1, 2019, the Company no longer measures these warrants at fair value. In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which amends the impairment model by requiring entities to use a forward-looking approach based on expected losses rather than incurred losses to estimate credit losses on certain types of financial instruments, including trade receivables. ASU 2016-13 was adopted by the Company on January 1, 2020 and had no current impact on the Company as the Company did not have any financial instruments covered by the topic on the date of adoption. In December 2020, the Company recognized its first sales of Twirla resulting in a receivable of $0.9 million at December 31, 2020 and an immaterial allowance for credit losses. As of December 31, 2021, receivables total $1.5 million, and the allowance for credit losses is immaterial. In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”). This guidance simplifies the accounting for income taxes by, among other things, reducing complexity in the interim-period accounting for year-to-date loss limitations and changes in tax laws. The guidance is effective for the Company on January 1, 2021. The Company is currently evaluating the impact of adopting this standard and does not expect the guidance to have a material impact on its consolidated financial statements. In January 2021, the FASB issued ASU 2021-01, Reference Rate Reform (Topic 848), an expansion of ASU 2020-04: Facilitation of the Effects of Reference Rate Reform on Financial Reporting (“ASU 2021-01”). This guidance permits entities to elect certain optional expedients and exceptions when accounting for derivative contracts and certain hedging relationships affected by changes in the interest rates used for discounting cash flows, for computing variation margin settlements, and for calculating price alignment interest) in connection with reference rate reform activities under way in global financial markets (the “discounting transition”). The guidance was effective immediately and did not have an impact on our consolidated 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, 2021 | |
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 and 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 or liabilities. 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, 2021 and 2020: Level 1 Level 2 Level 3 December 31, 2021 Assets: Cash and cash equivalents $ 19,143 $ — $ — Total assets at fair value $ 19,143 $ — $ — Level 1 Level 2 Level 3 December 31, 2020 Assets: Cash and cash equivalents $ 14,463 $ — $ — Marketable securities — 40,008 — Total assets at fair value $ 14,463 $ 40,008 $ — There were no transfers between Level 1, 2 or 3 during 2021 or 2020. |
Marketable Securities
Marketable Securities | 12 Months Ended |
Dec. 31, 2021 | |
Marketable Securities | |
Marketable Securities | 4. Marketable Securities The Company had no marketable securities as of December 31, 2021. The following is a summary of marketable securities as of December 31, 2020, classified as available-for-sale: Gross Unrealized Amortized Fair Cost Gains Losses Value December 31, 2020 U.S. government obligations (maturing in one year or less) $ 7,035 $ 2 $ — $ 7,037 Corporate debt securities (maturing in one year or less) 32,970 1 — 32,971 Total marketable securities $ 40,005 $ 3 $ — $ 40,008 The Company holds investment-grade marketable securities. There were no continuous unrealized loss positions in excess of twelve months as of December 31, 2021. |
Prepaid Expenses
Prepaid Expenses | 12 Months Ended |
Dec. 31, 2021 | |
Prepaid Expenses | |
Prepaid Expenses | 5. Prepaid Expenses Prepaid expenses consist of the following: December 31, 2021 2020 Prepaid insurance $ 775 $ 680 Other 1,508 769 Total prepaid expenses and other current assets $ 2,283 $ 1,449 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2021 | |
Property and Equipment | |
Property and Equipment | 6. 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 2021 2020 Life Office equipment $ 7 $ — 5 years Computer equipment 113 — 3 Years Manufacturing equipment 14,477 14,328 7 years 14,597 14,328 Less: accumulated depreciation (2,150) (85) Property and equipment $ 12,447 $ 14,243 Upon successful completion of the validation of the commercial manufacturing process for Twirla by the Company’s contract manufacturer, Corium, and the announcement of the commercial launch of Twirla in December 2020, manufacturing equipment with a cost of $14.3 million was placed into service and started being depreciated. |
Accrued Liabilities
Accrued Liabilities | 12 Months Ended |
Dec. 31, 2021 | |
Accrued Liabilities | |
Accrued Liabilities | 7. Accrued Liabilities Accrued liabilities consist of the following: December 31, 2021 2020 Accrued compensation $ 2,086 $ 1,697 Accrued professional fees and other 1,477 1,651 Total accrued liabilities $ 3,563 $ 3,348 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases | |
Leases | 8. Leases In February 2016, the FASB issued ASU No. 2016-02, Leases . The new standard establishes a right-of-use (ROU) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases are classified as either finance or operating, with classification affecting the pattern of expense recognition in the statement of operations. The Company adopted ASU No. 2016-02 on January 1, 2019 for leases that existed on that date. The Company has elected to apply the provisions of ASC 842 modified retrospectively at January 1, 2019 through a cumulative-effect adjustment. Prior period results continue to be presented under ASC 840 based on the accounting standards originally in effect for such periods. The Company has no 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 $180,000 and $190,000 for the years ended December 31, 2021 and 2020, respectively. Operating cash flows used for operating leases during the years ended December 31, 2021 and 2020 were $131,000 and $184,000 respectively. As of December 31, 2021, the weighted-average remaining lease term was 3.25 years and the weighted average discount rate was 11.8%. Future minimum lease payments under non-cancellable leases as of December 31, 2021 were as follows: Year ending December 31, 2022 277 2023 390 2024 398 2025 $ 101 Total $ 1,166 Less: Interest (207) Present value of lease liability $ 959 |
Credit Agreement and Guaranty
Credit Agreement and Guaranty | 12 Months Ended |
Dec. 31, 2021 | |
Credit Agreement and Guaranty | |
Credit Agreement and Guaranty | 9. Credit Agreement and Guaranty million tranche was to be available to the Company based on the achievement of a revenue milestone by December 31, 2021. We did not achieve that milestone and that tranche is no longer available to us. On February 26, 2021 the Perceptive Credit Agreement was amended (“Amended Perceptive Credit Agreement”) by creating a fourth tranche of $10.0 million that will be available based on the achievement of a revenue milestone. We currently do not believe we will achieve the milestone for the fourth tranche of $10.0 million. On January 7, 2022, the Company and Perceptive entered into a second amendment to the Amended Perceptive Credit Agreement (the “Second Amendment”). The Second Amendment waives the Company’s obligations to comply with certain financial covenants relating to minimum revenue requirements through September 30, 2022 and to file financial statements along with its Annual Report on Form 10-K that are not subject to any “going concern” qualification. The effectiveness of the Second Amendment is conditioned upon the satisfaction of certain conditions, including the Company raising additional capital and prepaying a portion of its outstanding debt. On January 7, 2022, the Company prepaid $5.0 million of the outstanding debt, and in accordance with the terms of the Second Amendment, no prepayment premium was due. The facility will mature on February 10, 2024 (“Maturity Date”). The Company is scheduled to make interest-only payments on the loans under the Perceptive Credit Agreement until February 10, 2023. Thereafter, the Company is required to make monthly principal payments in an amount equal to 1.50 % of the principal amount of the outstanding loans until February 10, 2024. Borrowings under the Second Amendment will accrue interest at an annual rate equal to . The rate of interest in effect as of the Closing Date and at December 31, 2021 was 11.75% . Upon the occurrence and during the continuance of any event of default under the Second Amendment, the interest rate automatically increases by 3.0% per annum. The Company may prepay any outstanding loans in whole or in part. Any such prepayment of the loans is subject to a prepayment fee of 8.0% if such prepayment occurs on or prior to February 10, 2022; 4.0% if such prepayment occurs after February 10, 2022 and on or prior to February 10, 2023; and 2.0 % if such prepayment occurs after February 10, 2023 and prior to February 10, 2024. The Company made a prepayment of $5.0 million on January 7, 2022 in connection with the Second Amendment. The prepayment fee was waived by Perceptive. All of the Company’s obligations under the Second Amendment 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 Second Amendment 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 Amended 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 Amended Perceptive Credit Agreement. In addition, the Company must (i) at all times prior to the Maturity Date maintain a minimum cash balance of $3.0 million; and (ii) as of the last day of each fiscal quarter commencing with the fiscal quarter ending December 31, 2022, report revenues for the trailing 12-month period that exceed the amounts set forth in the Second Amendment, which range from $53.0 million for the fiscal quarter ending December 31, 2022 to $87.1 million for the fiscal quarter ending December 31, 2023. The Company received covenant waivers for the failure to achieve the revenue covenants in 2021 and pertaining to the existence of substantial doubt about the Company’s ability to continue as a going concern as disclosed in Note 1. The Company was in compliance with the remaining covenants under the Second Amendment as of December 31, 2021. In connection with the Perceptive Credit Agreement, the Company issued to Perceptive two warrants to purchase an aggregate of 1,400,000 shares of the Company’s common stock (together, the “Perceptive Warrants”). The first warrant is exercisable for 700,000 shares of common stock at an exercise price of $3.74 per share. The second warrant is exercisable for 700,000 shares of common stock at an exercise price of $4.67 per share. The Perceptive Warrants contain anti-dilution provisions and other warrant holder protections. The Perceptive Warrants are not exercisable to the extent that Perceptive would beneficially own more than 19.99% of the Company’s common stock as a result of the exercise. The Perceptive Warrants expire on February 10, 2027. In connection with the Amended Perceptive Credit Agreement, the Company issued to Perceptive a warrant to purchase 450,000 shares of the Company’s common stock at an exercise price of $2.87 per share. As a result of the public offering of the Company’s common stock completed in October 2021 (see Note 10), the anti-dilution provision of the Perceptive Warrants was triggered resulting in a reduction of the strike price for the Perceptive Warrants. Warrants to purchase 700,000 shares of common stock that had an exercise price of $4.67 per share were reduced to $3.83 per share, warrants to purchase 700,000 shares of common stock that had an exercise price of $3.74 per share were reduced to $3.11 per share, and warrants to purchase 450,000 shares of common stock that had an exercise price of $2.87 per share were reduced to $2.43 per share. The Company allocated the proceeds of $20.0 million in accordance with ASC 470 based on the relative fair values of the debt and warrants. The relative fair value of the warrants of approximately $3.6 million at the time of issuance, which was determined using the Black-Scholes option-pricing model, was recorded as additional paid-in capital and reduced the carrying value of the debt. The significant assumptions used in preparing the option pricing model for valuing the Company’s warrants issued to Perceptive include (i) volatility (70.0%), (ii) risk free interest rate of 1.47% (estimated using treasury bonds with a 3-year life), (iii) strike prices of $3.74 and $4.67 for the common stock warrants, (iv) fair value of common stock ($4.01) and (v) expected life ( 7 years). The fair value of the warrants as well as the debt issue costs incurred in connection with the entry into the Perceptive Credit Agreement, including a facility fee of 1% of the total amount of loans available under the facility, are presented as a direct deduction from the carrying amount of the term loan on the consolidated balance sheet as detailed below. December 31, 2021 2020 Notes payable $ 20,000 $ 20,000 Debt issuance costs (550) (828) Warrant discount (2,617) (2,791) Total debt $ 16,833 $ 16,381 Less, current portion 16,833 — Long-term debt, less current portion $ — $ 16,381 As noted above, the Company obtained a waiver pertaining to the failure to achieve the revenue covenants in 2021. The Company’s future revenue is difficult to predict, and there is no assurance that the Company will be able to obtain additional waivers for any future failures to achieve revenue covenants. Accordingly, the total outstanding debt has been classified as current as of December 31, 2021. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2021 | |
Stockholders' Equity | |
Stockholders' Equity | 10. Stockholders’ Equity The Company’s Certificate of Incorporation, among other things: (i) authorizes 150,000,000 shares of common stock; (ii) authorizes 10,000,000 shares of undesignated preferred stock that may be issued from time to time by the Board in one or more series; (iii) provides that the Board be divided into three classes with staggered three-year terms, with one class of directors to be elected at each annual meeting of the Company’s stockholders; (iv) provides that directors may only be removed with cause and only upon the affirmative vote of holders of at least 75% of the voting power of all then-outstanding shares of capital stock of the Company entitled to vote generally in the election of directors; (v) provides that only the Board, the chairman of the Board or the chief executive officer may call a special meeting of stockholders; and (vi) requires that any action instituted against the Company’s officers or directors in connection with their service to the Company be brought in the State of Delaware. 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. Shelf Registration Statements 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. Prior to the 2020 Shelf Registration Statement, the Company had filed a universal shelf registration statement in November 2018 for the issuance of up to $100.0 million of securities, (“the 2018 Shelf Registration Statement”), which was declared effective by the SEC on November 14, 2018. On January 23, 2019, the Company filed a prospectus supplement to the 2018 Shelf Registration Statement registering an at-the-market offering program entered into for the sale of up to $10.0 million of shares of the Company’s common stock. In the year ended December 31, 2019, the Company sold a total of 1,801,528 shares of the Company’s common stock under the ATM program resulting in net proceeds of approximately $2.5 million. In August 2019, the Company filed a prospectus supplement to the 2018 Shelf Registration Statement registering a public offering of 14,526,315 shares of common stock at a price of $0.95 per share. Proceeds from the public offering, net of underwriting discounts, commissions and offering expenses, were approximately $12.7 million. On November 8, 2019, the Company filed a prospectus supplement to the 2018 Shelf Registration Statement registering an at-the-market offering program entered into for the sale of up to $20.0 million of shares of the Company’s common stock. In the year ended December 31, 2019, the Company sold a total of 10,440,908 shares of common stock under this ATM program, representing all of the capacity, resulting in net proceeds of approximately $19.3 million. On February 21, 2020, the Company filed a prospectus supplement to the 2018 Shelf Registration Statement registering a public offering of 17,250,000 shares of common stock at a price of $3.00 per share. Proceeds from the public offering, net of underwriting discounts, commissions and offering expenses were approximately $48.4 million. On March 18, 2021, the Company filed a prospectus supplement to the 2020 Shelf Registration Statement registering an at-the-market offering program entered into for the sale of up to $50.0 million of shares of the Company’s common stock. In the year ended December 31, 2021, the Company sold a total of 6,915,151 shares of common stock under this ATM program, resulting in net proceeds of approximately $9.3 million. On October 8, 2021, the Company filed a prospectus supplement to the 2020 Shelf Registration Statement registering a public offering of 26,666,648 shares of its common stock and warrants to purchase 13,333,324 shares of its common stock at a combined price of $0.85 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. 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 24,250,000 shares of the common stock of the Company (the “Common Stock”) and Series B warrants (the “Series B Warrants”) to purchase up to an aggregate of 24,250,000 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 $0.20 per share. The shares of preferred stock issued in the offering are convertible into an aggregate of 24,250,000 shares of Common Stock . Proceeds from the direct offering, net of the placement agent’s fees and offering expenses were approximately Private Placement In March 2019, the Company completed a private placement of 8,426,750 shares of common stock at $0.93 per share. Proceeds from the Company’s private placement, net of offering costs were approximately $7.8 million. Common Stock Warrants shares of its common stock. These warrants contain anti-dilution provisions that were triggered upon the Company’s public offering that was completed in October 2021. As a result of the offering, warrants to purchase 700,000 shares of common stock that had an exercise price of $4.67 per share were reduced to $3.83 per share, warrants to purchase 700,000 shares of common stock that had an exercise price of $3.74 per share were reduced to $3.11 per share, and warrants to purchase 450,000 shares of common stock that had an exercise price of $2.87 per share were reduced to $2.43 per share. This repricing resulted in an immaterial increase to additional paid-in-capital. |
Equity Incentive Plans
Equity Incentive Plans | 12 Months Ended |
Dec. 31, 2021 | |
Equity Incentive Plans | |
Equity Incentive Plans | 11. 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. As of December 31, 2021, there were 1,507,871 shares available for future grant under the Amended 2014 Plan. Through December 31, 2021, the Company granted options to certain employees and nonemployees to purchase shares of common stock at exercise prices ranging from $0.58 to $10.75 per share. The Company recorded noncash stock-based compensation expense for the years ended December 31, 2021, 2020 and 2019 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, 2021 2020 2019 Cost of goods sold $ 271 $ 14 $ — Research and development 490 651 522 Selling and marketing 148 108 — General and administrative 2,429 2,045 1,240 Total $ 3,338 $ 2,818 $ 1,762 The following assumptions were used to compute employee stock-based compensation under the Black-Scholes option pricing model: 2021 2020 2019 Risk‑free interest rate .66% - 1.51 % .40% - 1.68 % 1.74% ‑ 2.61 % Expective volatility 105% ‑ 106 % 65% ‑ 106 % 65 % 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. The expected volatility assumption was based on volatilities of a peer group of similar companies whose share prices are publicly available until August 2020. The peer group was developed based on comparable companies in the biotechnology and pharmaceutical industries. In August 2020, the Company transitioned to its own expected volatility based on sufficient 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 historic 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, 2021, the unrecorded deferred stock-based compensation balance related to stock options was approximately $6.4 million and will be recognized over an estimated weighted-average amortization period of 2.5 years. The weighted average grant date fair value of options granted during the year ended December 31, 2021 was $2.63. The following table summarizes the options outstanding, options vested and the options exercisable as of December 31, 2021, 2020 and 2019: Weighted Weighted Average Average Remaining Exercise Contractual Aggregate Options Price Life (Years) Intrinsic Value Options outstanding at December 31, 2019 7,192,357 3.42 7.2 Options granted 2,539,403 2.80 Options exercised (503,448) 1.21 Options cancelled/forfeited (709,226) 6.20 Options outstanding at December 31, 2020 8,519,086 3.13 7.3 Options granted 2,581,647 2.63 Options exercised (126,400) 0.60 Options cancelled/forfeited (606,891) 6.61 Options outstanding at December 31, 2021 10,367,442 2.83 7.1 $ — Options exercisable at December 31, 2021 6,262,675 2.99 6.0 $ — Vested and expected to vest at December 31, 2021 10,367,442 $ — Intrinsic value in the tables was calculated as the difference between the Company's stock price at December 31, 2021, of $0.49 per share, and the exercise price, multiplied by the number of options. Restricted Stock Units During the year ended December 31, 2020, the Company granted a total of 52,651 RSUs to executive officers of the Company. These RSUs vested on the one-year anniversary of the grant date. During the year ended December 31, 2020, the Company granted a total of 107,144 RSUs to directors of the Company. These RSUs vest ratably over one and three years . During the year ended December 31, 2021, the Company granted a total of 70,923 RSUs to certain employees of the Company. These RSUs vest on the one-year anniversary of the grant date. During the year ended December 31, 2021, the Company granted a total of 226,353 RSUs to directors of the Company. These RSUs vest ratably over one and three years . As of December 31, 2021, the unrecorded deferred stock-based compensation balance related to RSUs was approximately $250,000 and will be recognized over an estimated weighted-average amortization period of 1.0 years. The following table shows the Company's restricted stock unit activity during the years ended December 31, 2021, and 2020: Weighted Average Aggregate Shares Grant Date Fair Value Intrinsic Value Restricted stock units outstanding at December 31, 2019 — Granted 159,795 2.81 Restricted stock units outstanding at December 31, 2020 159,795 — $ 458 Granted 297,576 1.68 Vested (124,081) 2.81 Restricted stock units outstanding at December 31, 2021 333,290 1.80 $ 163 Performance Based Restricted Stock Awards In January 2018, the Company granted up to 365,000 shares of performance-based restricted stock units ("Performance Units") under the 2014 Plan primarily to executive officers, which were largely contingent upon the achievement of performance goals during the performance period beginning on the date of grant and ending on December 31, 2019 as set forth in each individual's Performance Unit agreement. Performance Units granted in January 2018 replaced Performance Units granted in April 2017 which expired. During 2018, 50,000 Performance Units were cancelled and as of December 31, 2018 315,000 Performance Units remained outstanding. The remaining 315,000 Performance Units expired in December 2019 as the performance goals were not achieved, and there are no Performance Units outstanding as of December 31, 2021. |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Income | 12 Months Ended |
Dec. 31, 2021 | |
Accumulated Other Comprehensive Income Loss Net of Tax [Abstract] | |
Accumulated Other Comprehensive Income | 12. Accumulated Other Comprehensive Income The change in accumulated other comprehensive income, which is reported as a component of stockholders’ equity, for the year ended December 31, 2021 is summarized below: Unrealized Gain on Marketable Securities Balance December 31, 2020 $ 3 Other comprehensive income (3) Balance December 31, 2021 $ — |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Taxes | |
Income Taxes | 13. Income Taxes In December 2017, in accordance with the SEC Staff Accounting Bulletin (“SAB”) 118–Income Tax Accounting Implications of the Tax Cuts and Jobs Act of 2017 (the “TCJA”), the Company recorded tax effects on a provisional basis based on a reasonable estimate. The TCJA did not have a material impact on the Company's financial statements because its deferred temporary differences are fully offset by a valuation allowance and the Company does not have any offshore earnings from which to record the mandatory transition tax. During 2018, the Company completed its analysis under SAB 118 and no additional tax effects due to rate-remeasurement were required to be recorded. 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, 2021, the Company had available net operating loss carryforwards (“NOLs”) of approximately $347.6 million for federal and $116.0 million for state income tax reporting purposes. Under the TCJA, the federal NOLs generated after 2017, approximately $154.0 million, can be carried forward indefinitely, while the NOLs generated through taxable years ending December 31, 2017, approximately $194.0 million, are available to offset future federal taxable income, if any, through 2038. The Company also has research and development tax credit carryforwards of approximately $6.4 million and $1.9 million for federal and state income tax reporting purposes, respectively, which are available to reduce federal income taxes, if any, through 2041 and state income taxes, if any, through 2036. 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. As of December 31, 2021, the Company has not accrued interest or penalties related to uncertain tax positions. The Company’s tax returns for the years ended December 31, 2018 through December 31, 2020 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, 2021, 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 in 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, 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 81,102 $ 66,907 Research credit carryforward 7,943 7,909 Stock options and other 2,114 1,962 Total gross deferred tax assets 91,159 76,778 Valuation allowance for deferred tax assets (91,159) (76,778) Net deferred tax assets $ — $ — The net change in the valuation allowance for the years ended December 31, 2021 and 2020 was an increase of $14.4 million and an increase of $10.6 million, respectively. A reconciliation of the U.S. statutory income tax rate to the Company’s effective tax rate is as follows: December 31, 2021 2020 2019 Federal income tax at statutory rate 21.0 % 21.0 % 21.0 % State income tax benefit, net of federal benefit 0.3 % 1.0 % 7.0 % Research and development tax credits 0.2 % 0.7 % 4.0 % Other (2.2) % (2.0) % (4.0) % Increase to valuation allowance (19.3) % (20.7) % (28.0) % Effective income tax rate 0.0 % 0.0 % 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. The Company received final approval in March 2022 for approximately |
2019 Retention Plan
2019 Retention Plan | 12 Months Ended |
Dec. 31, 2021 | |
2019 Retention Plan | |
2019 Retention Plan | 14. 2019 Retention Plan In July 2019, the Company adopted a retention plan (the “2019 Retention Plan”) for all employees (with the exception of the Chairman and Chief Executive Officer) in order to induce such employees to remain employed by the Company through at least the extended PDUFA goal date of February 14, 2020. Each employee who participated in the 2019 Retention Plan and remained continuously employed by the Company through the approval of Twirla was to be paid a lump-sum cash payment in an amount determined for each eligible employee by the Compensation Committee at the time of the adoption of the 2019 Retention Plan. If an eligible employee terminated employment prior to the approval for any reason, no such retention payment was payable to the eligible employee. With the approval of Twirla in February 2020, the cash portion of the 2019 Retention Plan in the amount of approximately $0.3 million was expensed and paid to eligible employees in February 2020. All employees (with the exception of the Chairman and Chief Executive Officer) who were employed by the Company as of July 3, 2019 were also granted a stock option to purchase the number of shares of common stock as approved by the Compensation Committee, with a per share exercise price of $1.48 , representing the closing price of the Company’s common stock as reported by Nasdaq on the date of grant. For each option, 50% of the option vested on July 3, 2020 and the remaining 50% vested on December 31, 2020. In addition, the vesting schedule for the stock options granted in January 2019 was amended for all employees (with the exception of the Chairman and Chief Executive Officer) holding such options who were employed on July 3, 2019 as follows: 50% of the option vested on January 29, 2020, 25% vested on June 30, 2020 and the remaining 25 % vested on December 31, 2020. The change in vesting schedule was approved by the Compensation Committee and did not have a material impact on the Company’s statement of operations. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies | |
Commitments and Contingencies | 15. 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 2030, total $5.2 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 2021 or termination amounts. Additionally, the Company purchases products and services as needed with no firm commitment. 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, 2021, the Company has not recorded a provision for any contingent losses. |
Subsequent Event
Subsequent Event | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Event [Abstract] | |
Subsequent Event | 16. Subsequent Events On January 7, 2022, 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, to increase the number of shares of common stock authorized for issuance from 150,000,000 shares to 300,000,000 shares. The Certificate of Amendment was effective upon filing, and was approved at a special meeting of stockholders (the “Special Meeting”) of the Company held on January 7, 2022. On January 7, 2022, the Company and Perceptive entered into the Second Amendment (see Note 9). On January 7, 2022, the Company prepaid $5.0 million of the outstanding debt, and in accordance with the terms of the Second Amendment, no prepayment premium was due with the prepayment. On March 10, 2022, the Company and Perceptive entered into a third amendment to the Perceptive Credit Agreement, as amended (the “Third Amendment”). The Third Amendment waived the Company’s obligations to (1) comply with certain financial covenants relating to minimum revenue requirements through September 30, 2022, conditioned upon the satisfaction of certain conditions, including the Company raising additional capital and prepaying a portion of its outstanding debt by April 30, 2022 and (2) file financial statements along with its Annual Report on Form 10-K for the fiscal year ended December 31, 2021 that are not subject to any “going concern” qualification. On March 13, 2022, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with a single healthcare-focused institutional investor (the “Purchaser”), pursuant to which the Company issued, in a registered direct offering (the “2022 Preferred Stock Offering”), 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 24,250,000 shares of the common stock of the Company (the “Common Stock”) and Series B warrants (the “Series B Warrants”) to purchase up to an aggregate of 24,250,000 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 $0.20 per share. The shares of preferred stock issued in the offering are convertible into an aggregate of 24,250,000 shares of Common Stock. The Series A Warrants have an exercise price of $0.26 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 $0.26 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. The Purchase Agreement contains customary representations and warranties and agreements of the Company and the Purchaser and customary indemnification rights and obligations of the parties. Total gross proceeds from the 2022 Preferred Stock Offering, before deducting the placement agent's fees and other estimated offering expenses, are $4.9 million. The 2022 Preferred Stock Offering closed on March 14, 2022. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
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, costs of product revenues, 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. It should be noted that current public health threats could adversely affect the Company’s ongoing or planned business operations. In particular, the ongoing COVID-19 pandemic has resulted in federal, state and local governments and private entities mandating various restrictions, including travel restrictions, access restrictions, restrictions on public gatherings, and stay at home orders. The effect of these orders, government imposed quarantines and measures the Company has taken, such as implementing work-at-home policies, may negatively impact productivity, disrupt the Company’s business and could delay the Company’s commercialization timeline. The Company cannot presently predict the scope and severity of any potential business shutdowns or disruptions, but if the Company or any of the third parties with whom it engages, including personnel at third-party manufacturing facilities and other third parties with whom the Company conducts business, were to experience shutdowns or other business disruptions, the Company’s ability to conduct its business in the manner and on the timeline presently planned could be materially and adversely impacted. It is unknown how long these conditions will last and what the complete effect will be on the Company. While to date we have been able to continue to execute our overall business plan, some of our business activities have been slowed and taken longer to complete and we continue to adjust to the challenges of operating in a largely remote setting with our employees. We have only recently launched our commercial activities for Twirla and begun engaging with healthcare providers to promote Twirla. We expect that, as we broaden our sales detailing activities, in some instances our sales force may encounter challenges engaging with healthcare providers during this on-going pandemic. Although many areas of the United States have begun to re-open access to offices and other commercial facilities, there continue to be areas where restrictions remain in place, which may have the potential to affect our ability to conduct our business. Further, new variants, including those which are more easily transmissible or resistant to existing vaccines, may lead to new shutdowns or business disruptions in the future. The Company will continue to closely monitor events as they develop and evaluate alternative, mitigating measures it can implement if needed. |
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. |
Marketable Securities | Marketable Securities The Company invests a portion of its excess cash balances in marketable securities, including U.S. government agency securities, and highly rated corporate bonds. The Company classifies all of its marketable securities as current assets on the balance sheet because they are available-for-sale and available to fund current operations. Marketable securities are stated at fair value with unrealized gains and losses included as a component of accumulated other comprehensive income (loss), which is a separate component of stockholders' equity, until such gains and losses are realized. If a decline in the fair value is considered other-than-temporary, based on available evidence, the unrealized loss is reclassified from accumulated other comprehensive income (loss) to the statements of operations. Realized gains and losses are determined on the specific identification method and are included in other income. |
Trade Accounts Receivable and Allowances | Trade Accounts Receivable and Allowances Trade accounts receivable are amounts owed to the Company by its customers for product that has been delivered. The trade 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 is 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, 2021 and 2020, respectively. Trade 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. During the year ended December 31, 2021, the Company established a reserve of approximately $5.3 million for inventory not expected to be sold prior to its shelf life date. The Company’s third-party manufacturer, Corium, completed the validation of the commercial manufacturing process for Twirla in the fourth quarter of 2020. The costs associated with validation batches were expensed as research and development expenses during the period the costs were incurred. The Company used this validation product for commercial supplies and samples of Twirla into May 2021. Since the Company did not capitalize any validation product, all sales of this validation product had no associated product cost. During the year ended Dectember 31, 2021, units sold with no associated product cost were approximately 3,000 . Had such inventory been valued at acquisition cost, it would have resulted in an immaterial increase to cost of goods sold and a corresponding decrease to gross profit. |
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. |
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 9) 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 $277,000, $231,000 and $0 for the years ended December 31, 2021, 2020 and 2019, 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 marketable securities. The Company invests its cash, cash equivalents and marketable securities in debt instruments and interest-bearing accounts in United States financial institutions, the balances of which exceed federally insured limits. The Company has not Major customers of the Company are defined as those constituting greater than 10% of its total revenue. In 2021, the Company had sales to customers that individually accounted for more than 10% of our total revenue. These customers had sales of of total revenues in the aggregate. Accounts receivable related to each of these major customers comprised |
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. Trade accounts receivable due to the Company from contracts with its customers are stated separately in the balance sheet, net of various allowances as described in the Trade 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 •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 significant 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 relied on industry standard data and trend analysis since historical sales data was not available as Twirla was launched in December 2020. As historical data becomes available, the Company will incorporate that data into its estimates of 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 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 trade 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 December 31, Allowances for Payments & December 31, 2020 current period sales credits 2021 Customer credits, discounts and allowances $ 187 $ 825 $ (641) $ 371 Rebates and co-pay assistance 116 1,055 (502) 669 Total $ 303 $ 1,880 $ (1,143) $ 1,040 |
Warrants | Warrants The Company accounts for its warrants to purchase common stock in accordance with ASC 480, Distinguishing Liabilities from Equity . On January 1, 2019, the Company adopted the provisions of Accounting Standards Update (“ASU”) 2017-11 Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (Part I) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Non-controlling Interests with a Scope Exception, In connection with entering into a senior secured term loan facility in February 2020, the Company issued warrants to purchase 1,400,000 shares of its common stock. In connection with an amendment to that facility in February 2021, the Company issued a warrant to purchase 450,000 shares of the Company’s common stock. In connection with an underwritten public offering completed in October 2021, the Company issued warrants to purchase 13,333,324 shares of its common stock. This offering also triggered an adjustment to the exercise price of the existing warrants mentioned above, which resulted in a reduction of the strike price for these warrants. This reduction resulted in an immaterial increase to additional paid in capital. S |
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 |
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. Cost associated with performance-based restricted stock units with a performance condition which affects the vesting is recognized only if the performance condition is probable of being satisfied. |
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 segment, which is the business of commercializing its transdermal patch for use in contraception. |
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, 2021, 2020 and 2019, respectively, because to do so would be anti-dilutive (in common equivalent shares): Year Ended December 31, 2021 2020 2019 Common stock warrants 15,183,324 1,400,000 180,274 Unvested restricted stock units 333,290 159,795 — Common stock options 10,367,442 8,519,086 7,192,357 Total 25,884,056 10,078,881 7,372,631 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard setting bodies that the Company adopts as of the specified effective date. Unless otherwise discussed below, the Company does not believe that the adoption of recently issued standards have or may have a material impact on our consolidated financial statements or disclosures. In July 2017, the FASB issued ASU No. 2017-11, Earnings Per Share (Topic 260); Distinguishing Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic 815): (Part 1) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception. additional paid-in capital. As a result of the adoption of ASU 2017-11, effective January 1, 2019, the Company no longer measures these warrants at fair value. In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which amends the impairment model by requiring entities to use a forward-looking approach based on expected losses rather than incurred losses to estimate credit losses on certain types of financial instruments, including trade receivables. ASU 2016-13 was adopted by the Company on January 1, 2020 and had no current impact on the Company as the Company did not have any financial instruments covered by the topic on the date of adoption. In December 2020, the Company recognized its first sales of Twirla resulting in a receivable of $0.9 million at December 31, 2020 and an immaterial allowance for credit losses. As of December 31, 2021, receivables total $1.5 million, and the allowance for credit losses is immaterial. In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes (“ASU 2019-12”). This guidance simplifies the accounting for income taxes by, among other things, reducing complexity in the interim-period accounting for year-to-date loss limitations and changes in tax laws. The guidance is effective for the Company on January 1, 2021. The Company is currently evaluating the impact of adopting this standard and does not expect the guidance to have a material impact on its consolidated financial statements. In January 2021, the FASB issued ASU 2021-01, Reference Rate Reform (Topic 848), an expansion of ASU 2020-04: Facilitation of the Effects of Reference Rate Reform on Financial Reporting (“ASU 2021-01”). This guidance permits entities to elect certain optional expedients and exceptions when accounting for derivative contracts and certain hedging relationships affected by changes in the interest rates used for discounting cash flows, for computing variation margin settlements, and for calculating price alignment interest) in connection with reference rate reform activities under way in global financial markets (the “discounting transition”). The guidance was effective immediately and did not have an impact on our consolidated 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, 2021 | |
Summary of Significant Accounting Policies | |
Summary of sales allowances and related accruals | December 31, Allowances for Payments & December 31, 2020 current period sales credits 2021 Customer credits, discounts and allowances $ 187 $ 825 $ (641) $ 371 Rebates and co-pay assistance 116 1,055 (502) 669 Total $ 303 $ 1,880 $ (1,143) $ 1,040 |
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, 2021, 2020 and 2019, respectively, because to do so would be anti-dilutive (in common equivalent shares): Year Ended December 31, 2021 2020 2019 Common stock warrants 15,183,324 1,400,000 180,274 Unvested restricted stock units 333,290 159,795 — Common stock options 10,367,442 8,519,086 7,192,357 Total 25,884,056 10,078,881 7,372,631 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
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, 2021 Assets: Cash and cash equivalents $ 19,143 $ — $ — Total assets at fair value $ 19,143 $ — $ — Level 1 Level 2 Level 3 December 31, 2020 Assets: Cash and cash equivalents $ 14,463 $ — $ — Marketable securities — 40,008 — Total assets at fair value $ 14,463 $ 40,008 $ — |
Marketable Securities (Tables)
Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Marketable Securities | |
Summary of marketable securities, classified as available-for-sale | Gross Unrealized Amortized Fair Cost Gains Losses Value December 31, 2020 U.S. government obligations (maturing in one year or less) $ 7,035 $ 2 $ — $ 7,037 Corporate debt securities (maturing in one year or less) 32,970 1 — 32,971 Total marketable securities $ 40,005 $ 3 $ — $ 40,008 |
Prepaid Expenses (Tables)
Prepaid Expenses (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Prepaid Expenses | |
Schedule of prepaid expenses | December 31, 2021 2020 Prepaid insurance $ 775 $ 680 Other 1,508 769 Total prepaid expenses and other current assets $ 2,283 $ 1,449 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property and Equipment | |
Schedule of components of property and equipment | December 31, Estimated 2021 2020 Life Office equipment $ 7 $ — 5 years Computer equipment 113 — 3 Years Manufacturing equipment 14,477 14,328 7 years 14,597 14,328 Less: accumulated depreciation (2,150) (85) Property and equipment $ 12,447 $ 14,243 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accrued Liabilities | |
Schedule of accrued liabilities | December 31, 2021 2020 Accrued compensation $ 2,086 $ 1,697 Accrued professional fees and other 1,477 1,651 Total accrued liabilities $ 3,563 $ 3,348 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases | |
Maturity of lease liabilities | Future minimum lease payments under non-cancellable leases as of December 31, 2021 were as follows: Year ending December 31, 2022 277 2023 390 2024 398 2025 $ 101 Total $ 1,166 Less: Interest (207) Present value of lease liability $ 959 |
Credit Agreement and Guaranty (
Credit Agreement and Guaranty (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Credit Agreement and Guaranty | |
Schedule of carrying amount of term loan | December 31, 2021 2020 Notes payable $ 20,000 $ 20,000 Debt issuance costs (550) (828) Warrant discount (2,617) (2,791) Total debt $ 16,833 $ 16,381 Less, current portion 16,833 — Long-term debt, less current portion $ — $ 16,381 |
Equity Incentive Plans (Tables)
Equity Incentive Plans (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Equity Incentive Plans | |
Schedule of stock-based compensation expense | Year Ended December 31, 2021 2020 2019 Cost of goods sold $ 271 $ 14 $ — Research and development 490 651 522 Selling and marketing 148 108 — General and administrative 2,429 2,045 1,240 Total $ 3,338 $ 2,818 $ 1,762 |
Schedule of assumptions used to compute employee stock-based compensation | 2021 2020 2019 Risk‑free interest rate .66% - 1.51 % .40% - 1.68 % 1.74% ‑ 2.61 % Expective volatility 105% ‑ 106 % 65% ‑ 106 % 65 % 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, 2019 7,192,357 3.42 7.2 Options granted 2,539,403 2.80 Options exercised (503,448) 1.21 Options cancelled/forfeited (709,226) 6.20 Options outstanding at December 31, 2020 8,519,086 3.13 7.3 Options granted 2,581,647 2.63 Options exercised (126,400) 0.60 Options cancelled/forfeited (606,891) 6.61 Options outstanding at December 31, 2021 10,367,442 2.83 7.1 $ — Options exercisable at December 31, 2021 6,262,675 2.99 6.0 $ — Vested and expected to vest at December 31, 2021 10,367,442 $ — |
Schedule of restricted stock activity | Weighted Average Aggregate Shares Grant Date Fair Value Intrinsic Value Restricted stock units outstanding at December 31, 2019 — Granted 159,795 2.81 Restricted stock units outstanding at December 31, 2020 159,795 — $ 458 Granted 297,576 1.68 Vested (124,081) 2.81 Restricted stock units outstanding at December 31, 2021 333,290 1.80 $ 163 |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive Income (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accumulated Other Comprehensive Income Loss Net of Tax [Abstract] | |
Schedule of change in accumulated other comprehensive income, which is reported as a component of stockholders' equity | Unrealized Gain on Marketable Securities Balance December 31, 2020 $ 3 Other comprehensive income (3) Balance December 31, 2021 $ — |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Taxes | |
Schedule of tax effects of temporary differences that give rise to significant portions of deferred tax assets | December 31, 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 81,102 $ 66,907 Research credit carryforward 7,943 7,909 Stock options and other 2,114 1,962 Total gross deferred tax assets 91,159 76,778 Valuation allowance for deferred tax assets (91,159) (76,778) Net deferred tax assets $ — $ — |
Schedule of reconciliation of U.S. statutory income tax rate to effective tax rate | December 31, 2021 2020 2019 Federal income tax at statutory rate 21.0 % 21.0 % 21.0 % State income tax benefit, net of federal benefit 0.3 % 1.0 % 7.0 % Research and development tax credits 0.2 % 0.7 % 4.0 % Other (2.2) % (2.0) % (4.0) % Increase to valuation allowance (19.3) % (20.7) % (28.0) % Effective income tax rate 0.0 % 0.0 % 0.0 % |
Organization and Description _2
Organization and Description of Business (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Nature of Operations | ||
Accumulated deficit | $ 387,117 | $ 312,223 |
Cash, cash equivalents and marketable securities | $ 19,100 |
Organization and Description _3
Organization and Description of Busines - Basis of Presentation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Organization and Description of Business | |||
Selling and marketing | $ 43,444 | $ 23,285 | $ 1,085 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Inventory (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2021USD ($)item | |
Summary of Significant Accounting Policies | |
Inventory reserve | $ | $ 5.3 |
Number of units sold | item | 3,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Advertising Costs (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Advertising costs | $ 13.8 | $ 5.5 | |
Manufacturing equipment | |||
Estimated useful life (in years) | 7 years | 7 years | 7 years |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Deferred Financing Costs (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Interest expense [Member] | |||
Deferred Financing Costs | |||
Amortization of deferred financing costs | $ 277,000 | $ 231,000 | $ 0 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Concentrations of Credit Risk (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021USD ($)customer | Dec. 31, 2020USD ($) | |
Concentration of risk, financial assets | ||
Financial instruments with off-balance sheet risk of accounting loss, assets | $ 0 | |
Concentration risk, financial liabilities | ||
Financial instruments with off-balance sheet risk of accounting loss, liabilities | 0 | |
Total revenue | $ 4,101 | $ 749 |
Customer Concentration Risk | ||
Concentration risk, financial liabilities | ||
Number of major customers | customer | 3 | |
Customer Concentration Risk | Sales Revenue | Customer One | ||
Concentration risk, financial liabilities | ||
Total revenue | $ 1,300 | |
Customer Concentration Risk | Sales Revenue | Customer Two | ||
Concentration risk, financial liabilities | ||
Total revenue | 1,300 | |
Customer Concentration Risk | Sales Revenue | Customer Three | ||
Concentration risk, financial liabilities | ||
Total revenue | $ 1,200 | |
Customer Concentration Risk | Sales Revenue | Three Customers | ||
Concentration risk, financial liabilities | ||
Concentration risk, percentage | 93.00% | |
Customer Concentration Risk | Accounts Receivable | Customer One | ||
Concentration risk, financial liabilities | ||
Concentration risk, percentage | 35.00% | |
Customer Concentration Risk | Accounts Receivable | Customer Two | ||
Concentration risk, financial liabilities | ||
Concentration risk, percentage | 34.00% | |
Customer Concentration Risk | Accounts Receivable | Customer Three | ||
Concentration risk, financial liabilities | ||
Concentration risk, percentage | 29.00% |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Co-Payment Assistance (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Accounts Receivable, Allowance for Credit Loss [Roll Forward] | |
Accounts Receivable, Beginning Balance | $ 303 |
Allowances for current period sales | 1,880 |
Payments & credits | (1,143) |
Accounts Receivable, Ending Balance | 1,040 |
Customer credits, discounts And allowances | |
Accounts Receivable, Allowance for Credit Loss [Roll Forward] | |
Accounts Receivable, Beginning Balance | 187 |
Allowances for current period sales | 825 |
Payments & credits | (641) |
Accounts Receivable, Ending Balance | 371 |
Rebates and co-pay assistance | |
Accounts Receivable, Allowance for Credit Loss [Roll Forward] | |
Accounts Receivable, Beginning Balance | 116 |
Allowances for current period sales | 1,055 |
Payments & credits | (502) |
Accounts Receivable, Ending Balance | $ 669 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Warrants (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Oct. 31, 2021 | Feb. 28, 2021 | Dec. 31, 2020 | Feb. 29, 2020 | Dec. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Warrants | ||||||||
Cumulative effect adjustment | $ 9,271 | $ 49,328 | $ 45,745 | $ 20,174 | ||||
Common stock that can be purchased with warrants (in shares) | 13,333,324 | 450,000 | ||||||
Common stock warrants | ||||||||
Warrants | ||||||||
Common stock that can be purchased with warrants (in shares) | 1,400,000 | |||||||
Accumulated Deficit | ||||||||
Warrants | ||||||||
Cumulative effect adjustment | $ (387,117) | $ (312,223) | (260,370) | $ (241,551) | ||||
Cumulative Effect, Period of Adoption, Adjusted Balance [Member] | Accumulated Deficit | ||||||||
Warrants | ||||||||
Cumulative effect adjustment | $ (213) | |||||||
Cumulative Effect, Period of Adoption, Adjustment [Member] | ASU 2017-11 | Accumulated Deficit | ||||||||
Warrants | ||||||||
Cumulative effect adjustment | $ 213 |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Income Taxes (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Uncertainty in tax positions | |
Uncertain tax positions | $ 0 |
Summary of Significant Accou_11
Summary of Significant Accounting Policies - Net Loss Per Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Anti-dilutive securities | |||
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 25,884,056 | 10,078,881 | 7,372,631 |
Common stock warrants | |||
Anti-dilutive securities | |||
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 15,183,324 | 1,400,000 | 180,274 |
Restricted Stock Units | |||
Anti-dilutive securities | |||
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 333,290 | 159,795 | |
Common stock options | |||
Anti-dilutive securities | |||
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 10,367,442 | 8,519,086 | 7,192,357 |
Summary of Significant Accou_12
Summary of Significant Accounting Policies - Segment Information (Details) | 12 Months Ended |
Dec. 31, 2021segment | |
Segment Information | |
Number of operating segments | 1 |
Number of reporting segments | 1 |
Summary of Significant Accou_13
Summary of Significant Accounting Policies - Recent Accounting Pronouncements (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 |
Recent Accounting Pronouncements | |||||
Cumulative effect adjustment | $ 9,271 | $ 49,328 | $ 45,745 | $ 20,174 | |
Accounts receivable, net | 1,533 | 865 | |||
Twirla | |||||
Recent Accounting Pronouncements | |||||
Accounts receivable, net | 1,500 | 900 | |||
Additional Paid in Capital. | |||||
Recent Accounting Pronouncements | |||||
Cumulative effect adjustment | $ 396,376 | $ 361,539 | 306,108 | $ 261,722 | |
Additional Paid in Capital. | Cumulative Effect, Period of Adoption, Adjusted Balance [Member] | |||||
Recent Accounting Pronouncements | |||||
Cumulative effect adjustment | $ 213 | ||||
Additional Paid in Capital. | Cumulative Effect, Period of Adoption, Adjustment [Member] | ASU 2017-11 | |||||
Recent Accounting Pronouncements | |||||
Cumulative effect adjustment | $ 213 |
Fair Value Measurements - Finan
Fair Value Measurements - Financial Instruments Measured at Fair Value by Hierarchy Level (Details) - Recurring - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Level 1 | ||
Assets: | ||
Cash and cash equivalents | $ 19,143 | $ 14,463 |
Total assets at fair value | $ 19,143 | 14,463 |
Level 2 | ||
Assets: | ||
Marketable securities | 40,008 | |
Total assets at fair value | $ 40,008 |
Fair Value Measurements - Trans
Fair Value Measurements - Transfers Between Levels (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Fair value measurements | ||
Asset transfers out of Level 1 into Level 2 | $ 0 | $ 0 |
Asset transfers out of Level 2 into Level 1 | 0 | 0 |
Asset transfers into (out of) Level 3 | 0 | 0 |
Liability transfers out of Level 1 into Level 2 | 0 | 0 |
Liability transfers out of Level 2 into Level 1 | 0 | 0 |
Liability transfers into (out of) Level 3 | $ 0 | $ 0 |
Marketable Securities (Details)
Marketable Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Marketable Securities [Line Items] | ||
Amortized Cost (maturing in one year or less) | $ 40,005 | |
Gross Unrealized Gain (maturing in one year or less) | 3 | |
Fair Value (maturing in one year or less) | $ 40,008 | |
Investment-grade marketable securities in a continuous unrealized loss position for more than twelve months | 0 | |
Marketable securities | $ 0 | $ 40,008 |
U.S. government obligations | ||
Marketable Securities [Line Items] | ||
Amortized Cost (maturing in one year or less) | 7,035 | |
Gross Unrealized Gain (maturing in one year or less) | 2 | |
Fair Value (maturing in one year or less) | 7,037 | |
Corporate debt securities | ||
Marketable Securities [Line Items] | ||
Amortized Cost (maturing in one year or less) | 32,970 | |
Gross Unrealized Gain (maturing in one year or less) | 1 | |
Fair Value (maturing in one year or less) | $ 32,971 |
Prepaid Expenses (Details)
Prepaid Expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Prepaid Expenses | ||
Prepaid insurance | $ 775 | $ 680 |
Other | 1,508 | 769 |
Total prepaid expenses and other current assets | $ 2,283 | $ 1,449 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Property and Equipment | |||
Property and equipment, gross | $ 14,597 | $ 14,328 | |
Less: accumulated depreciation | (2,150) | (85) | |
Property and equipment, net | 12,447 | $ 14,243 | |
Office equipment | |||
Property and Equipment | |||
Property and equipment, gross | $ 7 | ||
Estimated Life (in years) | 5 years | 5 years | |
Computer equipment | |||
Property and Equipment | |||
Property and equipment, gross | $ 113 | ||
Estimated Life (in years) | 3 years | 3 years | |
Manufacturing equipment | |||
Property and Equipment | |||
Property and equipment, gross | $ 14,477 | $ 14,328 | |
Estimated Life (in years) | 7 years | 7 years | 7 years |
Accrued Liabilities (Details)
Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Accrued Liabilities | ||
Accrued compensation | $ 2,086 | $ 1,697 |
Accrued professional fees and other | 1,477 | 1,651 |
Total accrued liabilities | $ 3,563 | $ 3,348 |
Leases - Summary (Details)
Leases - Summary (Details) | 12 Months Ended | ||
Dec. 31, 2021USD ($)lease | Dec. 31, 2020USD ($) | Dec. 31, 2019USD ($) | |
Leases | |||
Number of finance leases | lease | 0 | ||
Number of operating leases | lease | 1 | ||
Lease liability | $ 959,000 | ||
Lease assets | 949,000 | $ 138,000 | |
Operating lease expense | 180,000,000 | 190,000,000 | |
Operating lease expense information: | |||
Cash paid for amounts included in measurement of lease liabilities | 131,000 | $ 184,000 | $ 152,000 |
ROU assets obtained in exchange for lease liabilities | $ 969,000 | ||
Weighted-average remaining lease term (years) | 3 years 3 months | ||
Weighted-average discount rate | 11.80% |
Leases - Maturity of lease liab
Leases - Maturity of lease liabilities (Details) $ in Thousands | Dec. 31, 2021USD ($) |
Operating Leases | |
2022 | $ 277 |
2023 | 390 |
2024 | 398 |
2025 | 101 |
Total | 1,166 |
Less: Interest | (207) |
Present value of lease liability | $ 959 |
Credit Agreement and Guaranty_2
Credit Agreement and Guaranty (Details) | Jan. 07, 2022USD ($) | Feb. 26, 2021USD ($) | Feb. 10, 2020USD ($)item$ / sharesshares | Dec. 31, 2023USD ($) | Mar. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Oct. 31, 2021$ / sharesshares | Sep. 30, 2021$ / shares | Feb. 28, 2021shares | Feb. 10, 2021$ / sharesshares |
Debt Instrument [Line Items] | ||||||||||
Amount borrowed | $ 20,000,000 | |||||||||
Interest rate (as a percent) | 11.75% | 11.75% | ||||||||
Percentage of annual interest rate | 3.00% | |||||||||
Common stock that can be purchased with warrants (in shares) | shares | 13,333,324 | 450,000 | ||||||||
Proceeds from warrant exercises | $ 20,000,000 | |||||||||
Fair value of warrants | $ 3,600,000 | |||||||||
Perceptive Credit Agreement | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Percentage of outstanding debt | 1.50% | |||||||||
Minimum cash covenants | $ 3,000,000 | |||||||||
Revenue generated under debt | $ 87,100,000 | $ 53,000,000 | ||||||||
Perceptive Credit Agreement | Perceptive Warrants | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 2.87 | |||||||||
Common stock that can be purchased with warrants (in shares) | shares | 1,400,000 | 1,850,000 | ||||||||
Beneficial ownership percentage | 19.99% | |||||||||
Facility fee percentage | 1.00% | |||||||||
Perceptive Credit Agreement | First Seven Lakhs Shares | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 3.74 | $ 3.83 | $ 4.67 | |||||||
Common stock that can be purchased with warrants (in shares) | shares | 700,000 | 700,000 | ||||||||
Perceptive Credit Agreement | Remaining Seven Lakhs Shares | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 4.67 | $ 3.11 | 3.74 | |||||||
Common stock that can be purchased with warrants (in shares) | shares | 700,000 | 700,000 | ||||||||
Perceptive Credit Agreement | Warrants | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 2.43 | $ 2.87 | ||||||||
Common stock that can be purchased with warrants (in shares) | shares | 450,000 | |||||||||
Perceptive Credit Agreement, Tranche Four | Perceptive Warrants | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Common stock that can be purchased with warrants (in shares) | shares | 450,000 | |||||||||
Senior secured delayed draw term loan facility | Perceptive Credit Agreement | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Maximum borrowing capacity | $ 35,000,000 | |||||||||
Senior secured delayed draw term loan facility | Perceptive Credit Agreement, Tranche One | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Amount borrowed | 5,000,000 | |||||||||
Senior secured delayed draw term loan facility | Perceptive Credit Agreement, Tranche Two | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Amount borrowed | 15,000,000 | |||||||||
Senior secured delayed draw term loan facility | Perceptive Credit Agreement, Tranche Three | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Amount borrowed | $ 15,000,000 | |||||||||
Senior secured delayed draw term loan facility | Perceptive Credit Agreement, Tranche Four | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Amount borrowed | $ 10,000,000 | |||||||||
Subsequent event | Perceptive Credit Agreement | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Repayments of Debt | $ 5,000,000 | |||||||||
Debt Instrument, Prepayment Premium Due | $ 0 | |||||||||
LIBOR | Perceptive Credit Agreement | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Variable interest rate margin (as a percent) | 10.25% | |||||||||
Interest rate for the base rate | 1.50% | |||||||||
Prepayment Occur on or Before February, 10, 2022 | Perceptive Credit Agreement | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Prepayment fee percent | 8.00% | |||||||||
Prepayment Occur on or Before February, 10, 2023 | Perceptive Credit Agreement | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Prepayment fee percent | 4.00% | |||||||||
Prepayment Occur on or Before February, 10, 2024 | Perceptive Credit Agreement | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Prepayment fee percent | 2.00% | |||||||||
Option pricing model | Common stock warrants | Perceptive Warrants | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Warrants and rights outstanding, term | 7 years | |||||||||
Option pricing model | Common stock warrants | Perceptive Warrants | Volatility | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Warrants, Measurement Input | 0.700 | |||||||||
Option pricing model | Common stock warrants | Perceptive Warrants | Risk free interest rate | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Warrants, Measurement Input | 0.0147 | |||||||||
Option pricing model | Common stock warrants | Perceptive Warrants | Share price [Member] | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Warrants, Measurement Input | item | 4.01 | |||||||||
Option pricing model | Common stock warrants | Maximum | Perceptive Warrants | Strike price | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Warrants, Measurement Input | item | 4.67 | |||||||||
Option pricing model | Common stock warrants | Minimum | Perceptive Warrants | Strike price | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Warrants, Measurement Input | item | 3.74 |
Credit Agreement and Guaranty -
Credit Agreement and Guaranty - Carrying Amount Of term Loan (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Credit Agreement and Guaranty | ||
Notes payable | $ 20,000 | $ 20,000 |
Debt issuance costs | (550) | (828) |
Warrant discount | (2,617) | (2,791) |
Total | 16,833 | 16,381 |
Less, current portion | $ 16,833 | |
Current portion, long-term debt | $ 16,381 |
Stockholders' Equity - Amended
Stockholders' Equity - Amended and Restated Certificate of Incorporation (Details) | 12 Months Ended | |
Dec. 31, 2021classshares | Dec. 31, 2020shares | |
Stockholders' Equity | ||
Common stock, authorized (in shares) | shares | 150,000,000 | 150,000,000 |
Preferred stock, authorized (in shares) | shares | 10,000,000 | |
Board of Directors, number of classes | class | 3 | |
Term of Board member | 3 years | |
Number of classes elected at each annual meeting | class | 1 | |
Minimum | ||
Stockholders' Equity | ||
Affirmative vote of all then-outstanding shares of capital stock for removal of directors (as a percent) | 75.00% |
Stockholders' Equity - Common S
Stockholders' Equity - Common Stock (Details) - USD ($) $ / shares in Units, $ in Thousands | Mar. 14, 2022 | Oct. 08, 2021 | Feb. 21, 2020 | Aug. 31, 2019 | Mar. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 10, 2022 | Oct. 31, 2021 | Sep. 30, 2021 | Mar. 18, 2021 | Feb. 28, 2021 | Feb. 10, 2021 | Oct. 02, 2020 | Feb. 10, 2020 | Nov. 08, 2019 | Jan. 23, 2019 |
Sale of stock | ||||||||||||||||||
Common stock that can be purchased with warrants (in shares) | 13,333,324 | 450,000 | ||||||||||||||||
Proceeds from issuance of common stock in private placement, net of offering costs | $ 7,810 | |||||||||||||||||
Number of warrants outstanding (in shares) | 13,333,324 | 450,000 | ||||||||||||||||
Perceptive Warrants | Perceptive Credit Agreement | ||||||||||||||||||
Sale of stock | ||||||||||||||||||
Common stock that can be purchased with warrants (in shares) | 1,850,000 | 1,400,000 | ||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 2.87 | |||||||||||||||||
Number of warrants outstanding (in shares) | 1,850,000 | 1,400,000 | ||||||||||||||||
First Seven Lakhs Shares | Perceptive Credit Agreement | ||||||||||||||||||
Sale of stock | ||||||||||||||||||
Common stock that can be purchased with warrants (in shares) | 700,000 | 700,000 | ||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 3.83 | $ 4.67 | $ 3.74 | |||||||||||||||
Number of warrants outstanding (in shares) | 700,000 | 700,000 | ||||||||||||||||
Remaining Seven Lakhs Shares | Perceptive Credit Agreement | ||||||||||||||||||
Sale of stock | ||||||||||||||||||
Common stock that can be purchased with warrants (in shares) | 700,000 | 700,000 | ||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 3.11 | 3.74 | $ 4.67 | |||||||||||||||
Number of warrants outstanding (in shares) | 700,000 | 700,000 | ||||||||||||||||
Warrants | Perceptive Credit Agreement | ||||||||||||||||||
Sale of stock | ||||||||||||||||||
Common stock that can be purchased with warrants (in shares) | 450,000 | |||||||||||||||||
Exercise price of warrants (in dollars per share) | $ 2.43 | $ 2.87 | ||||||||||||||||
Number of warrants outstanding (in shares) | 450,000 | |||||||||||||||||
2020 Shelf Registration Statement | ||||||||||||||||||
Sale of stock | ||||||||||||||||||
Aggregate amount of securities issuable | $ 200,000 | |||||||||||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 4,300 | |||||||||||||||||
Conversion price | $ 0.20 | |||||||||||||||||
Preferred Stock, convertible, shares issuable | 24,250,000 | |||||||||||||||||
Stock stated value | $ 1,000 | |||||||||||||||||
2020 Shelf Registration Statement | Series A Warrants | ||||||||||||||||||
Sale of stock | ||||||||||||||||||
Common stock that can be purchased with warrants (in shares) | 24,250,000 | |||||||||||||||||
Number of warrants outstanding (in shares) | 24,250,000 | |||||||||||||||||
2020 Shelf Registration Statement | Series B Warrants | ||||||||||||||||||
Sale of stock | ||||||||||||||||||
Common stock that can be purchased with warrants (in shares) | 24,250,000 | |||||||||||||||||
Number of warrants outstanding (in shares) | 24,250,000 | |||||||||||||||||
2018 Shelf Registration Statement | ||||||||||||||||||
Sale of stock | ||||||||||||||||||
Aggregate amount of securities issuable | $ 100,000 | |||||||||||||||||
Private Placement | Common stock | ||||||||||||||||||
Sale of stock | ||||||||||||||||||
Issuance of common stock (in shares) | 8,426,750 | 8,426,750 | ||||||||||||||||
Share price (in dollars per share) | $ 0.93 | |||||||||||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 7,800 | |||||||||||||||||
At-the-market sales | Maximum | ||||||||||||||||||
Sale of stock | ||||||||||||||||||
Authorized value for shares issuance | $ 20,000 | $ 10,000 | ||||||||||||||||
At-the-market sales | Common stock | ||||||||||||||||||
Sale of stock | ||||||||||||||||||
Issuance of common stock (in shares) | 6,915,151 | 12,242,436 | ||||||||||||||||
At-the-market sales | Common stock | Maximum | ||||||||||||||||||
Sale of stock | ||||||||||||||||||
Authorized value for shares issuance | $ 50,000 | |||||||||||||||||
At-the-market sales | Common stock | Maximum | Subsequent event | ||||||||||||||||||
Sale of stock | ||||||||||||||||||
Authorized value for shares issuance | $ 50,000 | |||||||||||||||||
At Market Sales on January 23 | ||||||||||||||||||
Sale of stock | ||||||||||||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 2,500 | |||||||||||||||||
At Market Sales on January 23 | Common stock | ||||||||||||||||||
Sale of stock | ||||||||||||||||||
Issuance of common stock (in shares) | 1,801,528 | |||||||||||||||||
At Market Sales on November 8 | ||||||||||||||||||
Sale of stock | ||||||||||||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 19,300 | |||||||||||||||||
At Market Sales on November 8 | Common stock | ||||||||||||||||||
Sale of stock | ||||||||||||||||||
Issuance of common stock (in shares) | 10,440,908 | |||||||||||||||||
At Market Sales on March 18 | Common stock | ||||||||||||||||||
Sale of stock | ||||||||||||||||||
Issuance of common stock (in shares) | 6,915,151 | |||||||||||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 9,300 | |||||||||||||||||
Public offering | ||||||||||||||||||
Sale of stock | ||||||||||||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 21,081 | $ 48,434 | $ 12,687 | |||||||||||||||
Public offering | Common stock | ||||||||||||||||||
Sale of stock | ||||||||||||||||||
Issuance of common stock (in shares) | 26,666,648 | 17,250,000 | 14,526,315 | 26,666,648 | 17,250,000 | 14,526,315 | ||||||||||||
Common stock that can be purchased with warrants (in shares) | 13,333,324 | |||||||||||||||||
Common stock that can be purchased with one-half of warrant (in shares) | 1 | |||||||||||||||||
Share price (in dollars per share) | $ 0.85 | $ 3 | $ 0.95 | |||||||||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 21,100 | $ 48,400 | $ 12,700 | |||||||||||||||
Number of warrants outstanding (in shares) | 13,333,324 | |||||||||||||||||
Series A Preferred Stock | 2020 Shelf Registration Statement | ||||||||||||||||||
Sale of stock | ||||||||||||||||||
Issuance of common stock (in shares) | 2,425 | |||||||||||||||||
Series B Preferred Stock | 2020 Shelf Registration Statement | ||||||||||||||||||
Sale of stock | ||||||||||||||||||
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, 2021$ / sharesshares | |
Minimum | |
Equity Incentive Plans | |
Exercise prices of options granted through the end of the year (in dollars per share) | $ 0.58 |
Maximum | |
Equity Incentive Plans | |
Exercise prices of options granted through the end of the year (in dollars per share) | $ 10.75 |
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 | 1,507,871 |
Equity Incentive Plans - Stock-
Equity Incentive Plans - Stock-Based Compensation (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Equity Incentive Plans | |||
Total stock-based compensation expense | $ 3,338 | $ 2,818 | $ 1,762 |
Assumptions used to compute employee stock based compensation under the Black-Scholes option pricing model | |||
Expected volatility (as a percent) | 65.00% | ||
Expected dividend yield (as a percent) | 0.00% | 0.00% | 0.00% |
Expected life (in years) | 6 years 3 months | 6 years 3 months | 6 years 3 months |
Minimum | |||
Assumptions used to compute employee stock based compensation under the Black-Scholes option pricing model | |||
Risk-free interest rate (as a percent) | 0.66% | 0.40% | 1.74% |
Expected volatility (as a percent) | 105.00% | 65.00% | |
Maximum | |||
Assumptions used to compute employee stock based compensation under the Black-Scholes option pricing model | |||
Risk-free interest rate (as a percent) | 1.51% | 1.68% | 2.61% |
Expected volatility (as a percent) | 106.00% | 106.00% | |
Common stock options | |||
Equity Incentive Plans | |||
Total stock-based compensation expense | $ 3,338 | $ 2,818 | $ 1,762 |
Unrecorded deferred stock-based compensation | |||
Unrecorded deferred stock-based compensation balance related to stock options | $ 6,400 | ||
Weighted-average amortization period over which cost is expected to be recognized | 2 years 6 months | ||
Weighted average grant date fair value of options granted (in dollars per share) | $ 2.63 | ||
Common stock options | Cost of goods sold | |||
Equity Incentive Plans | |||
Total stock-based compensation expense | $ 271 | 14 | |
Common stock options | Research and development | |||
Equity Incentive Plans | |||
Total stock-based compensation expense | 490 | 651 | 522 |
Common stock options | Selling and marketing | |||
Equity Incentive Plans | |||
Total stock-based compensation expense | 148 | 108 | |
Common stock options | General and administrative | |||
Equity Incentive Plans | |||
Total stock-based compensation expense | 2,429 | $ 2,045 | $ 1,240 |
Restricted Stock Units | |||
Unrecorded deferred stock-based compensation | |||
Unrecorded deferred stock-based compensation balance related to stock options | $ 250,000,000 | ||
Weighted-average amortization period over which cost is expected to be recognized | 1 year |
Equity Incentive Plans - Stoc_2
Equity Incentive Plans - Stock Option Activity (Details) - Common stock options - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Options | |||
Options outstanding at beginning of year (in shares) | 8,519,086 | 7,192,357 | |
Options granted (in shares) | 2,581,647 | 2,539,403 | |
Options exercised (in shares) | (126,400) | (503,448) | |
Options cancelled/forfeited (in shares) | (606,891) | (709,226) | |
Options outstanding at end of year (in shares) | 10,367,442 | 8,519,086 | 7,192,357 |
Options exercisable at end of year (in shares) | 6,262,675 | ||
Vested and expected to vest at end of year (in shares) | 10,367,442 | ||
Weighted Average Exercise Price | |||
Options outstanding at beginning of year (in dollars per share) | $ 3.13 | $ 3.42 | |
Options granted (in dollars per share) | 2.63 | 2.80 | |
Options exercised (in dollars per share) | 0.60 | 1.21 | |
Options cancelled/forfeited (in dollars per share) | 6.61 | 6.20 | |
Options outstanding at end of year (in dollars per share) | 2.83 | $ 3.13 | $ 3.42 |
Options exercisable at end of year (in dollars per share) | $ 2.99 | ||
Weighted Average Remaining Contractual Life (Years) | |||
Options outstanding | 7 years 1 month 6 days | 7 years 3 months 18 days | 7 years 2 months 12 days |
Options exercisable | 6 years | ||
Estimated stock price (in dollars per share) | $ 0.49 |
Equity Incentive Plans - Restri
Equity Incentive Plans - Restricted Stock (Details) - Restricted Stock Units - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Shares | ||
Restricted stock outstanding at beginning of year (in shares) | 159,795 | |
Granted (in shares) | 297,576 | 159,795 |
Vested (in shares) | (124,081) | |
Restricted stock outstanding at end of year (in shares) | 333,290 | 159,795 |
Weighted Average Grant Date Fair Value | ||
Granted (in dollars per share) | $ 1.68 | $ 2.81 |
Vested (in dollars per share) | 2.81 | |
Restricted stock outstanding at end of year (in dollars per share) | $ 1.80 | |
Aggregate Intrinsic Value | ||
Intrinsic value of vested shares | $ 163 | $ 458 |
Employee | ||
Shares | ||
Granted (in shares) | 70,923 | |
Vesting period | 1 year | |
Executive officers | ||
Shares | ||
Granted (in shares) | 52,651 | |
Vesting period | 1 year | |
Directors | ||
Shares | ||
Granted (in shares) | 226,353 | 107,144 |
Directors | Minimum | ||
Shares | ||
Vesting period | 1 year | 1 year |
Directors | Maximum | ||
Shares | ||
Vesting period | 3 years | 3 years |
Equity Incentive Plans - Perfor
Equity Incentive Plans - Performance Based Restricted Stock Awards (Details) - 2014 Incentive Compensation Plan - Performance Units - Executive officers - shares | 1 Months Ended | 12 Months Ended | ||
Jan. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2021 | Dec. 31, 2019 | |
Equity Incentive Plans | ||||
Shares granted | 365,000 | |||
Shares cancelled | 50,000 | |||
Shares outstanding | 315,000 | 0 | 315,000 |
Accumulated Other Comprehensi_3
Accumulated Other Comprehensive Income (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Accumulated Other Comprehensive Income Loss Net of Tax [Abstract] | ||
Balance at beginning of the period | $ 3 | |
Other comprehensive income of unrealized gain on marketable securities | $ (3) | $ 3 |
Balance at end of the period | $ 3 |
Income Taxes - Summary (Details
Income Taxes - Summary (Details) - USD ($) $ in Millions | 12 Months Ended | |||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Taxes | ||||
Corporate tax rate (as a percent) | 21.00% | 21.00% | 21.00% | |
Federal | Net Operating Losses | ||||
Income Taxes | ||||
Net operating loss carryforwards | $ 347.6 | $ 194 | ||
Indefinite net operating loss carryforward | 154 | |||
Federal | Research and Development. | ||||
Income Taxes | ||||
Tax credit carryforwards | 6.4 | |||
State | Net Operating Losses | ||||
Income Taxes | ||||
Net operating loss carryforwards | 116 | |||
State | Research and Development. | ||||
Income Taxes | ||||
Tax credit carryforwards | $ 1.9 |
Income Taxes - Deferred Taxes (
Income Taxes - Deferred Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 81,102 | $ 66,907 |
Research credit carryforward | 7,943 | 7,909 |
Stock options and other | 2,114 | 1,962 |
Total gross deferred tax assets | 91,159 | 76,778 |
Valuation allowance for deferred tax assets | (91,159) | (76,778) |
Net deferred tax assets | 0 | 0 |
Valuation allowance | ||
Increase (decrease) in the valuation allowance | $ 14,400 | $ 10,600 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of U.S. Statutory Income Tax Rate to Effective Tax Rate (Details) | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
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) | 21.00% | 21.00% | 21.00% |
State income tax benefit, net of federal benefit (as a percent) | 0.30% | 1.00% | 7.00% |
Research and development tax credits (as a percent) | 0.20% | 0.70% | 4.00% |
Other (as a percent) | (2.20%) | (2.00%) | (4.00%) |
Increase to valuation allowance (as a percent) | (19.30%) | (20.70%) | (28.00%) |
Effective income tax rate (as a percent) | 0.00% | 0.00% | 0.00% |
Income Taxes - Sale of New Jers
Income Taxes - Sale of New Jersey Net Operating Losses (Details) - USD ($) $ in Millions | 1 Months Ended | ||
Jan. 31, 2021 | Jan. 31, 2018 | Dec. 31, 2021 | |
Sale of New Jersey Net Operating Losses | |||
Additional cash benefit | $ 4.7 | ||
Sale of unused NOLs | New Jersey | |||
Sale of New Jersey Net Operating Losses | |||
Maximum lifetime benefit under the Program | $ 20 | $ 15 | |
Sale of unused NOLs | New Jersey | Minimum | |||
Sale of New Jersey Net Operating Losses | |||
Allowable sale of unused tax benefits as a percentage of total value | 80.00% |
2019 Retention Plan (Details)
2019 Retention Plan (Details) - USD ($) $ / shares in Units, $ in Millions | Jul. 03, 2019 | Dec. 31, 2021 | Feb. 29, 2020 |
2019 Retention Plan | |||
Cash portion of the retention plan | $ 0.3 | ||
Options granted In January 2019 | Vesting on December 31, 2020 | |||
2019 Retention Plan | |||
Percentage of options to vest | 25.00% | ||
Options granted In January 2019 | Vesting on January 29, 2020 | |||
2019 Retention Plan | |||
Percentage of options to vest | 50.00% | ||
Options granted In January 2019 | Vesting on June 30, 2020 | |||
2019 Retention Plan | |||
Percentage of options to vest | 25.00% | ||
Options granted in July 2019 | |||
2019 Retention Plan | |||
Stock option exercise price (in dollars per share) | $ 1.48 | ||
Options granted in July 2019 | Vesting on July 3, 2020 | |||
2019 Retention Plan | |||
Percentage of options to vest | 50.00% | ||
Options granted in July 2019 | Vesting on December 31, 2020 | |||
2019 Retention Plan | |||
Percentage of options to vest | 50.00% |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Millions | Dec. 31, 2021USD ($) |
Commitments and Contingencies | |
Future purchase commitments | $ 5.2 |
Subsequent Event (Details)
Subsequent Event (Details) - USD ($) | Mar. 14, 2022 | Mar. 13, 2022 | Jan. 07, 2022 | Oct. 08, 2021 | Feb. 21, 2020 | Aug. 31, 2019 | Mar. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 06, 2022 | Oct. 31, 2021 | Feb. 28, 2021 |
Subsequent Event [Line Items] | |||||||||||||
Common stock that can be purchased with warrants (in shares) | 13,333,324 | 450,000 | |||||||||||
Common Stock, Shares Authorized | 150,000,000 | 150,000,000 | |||||||||||
2020 Shelf Registration Statement | |||||||||||||
Subsequent Event [Line Items] | |||||||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 4,300,000 | ||||||||||||
Stock stated value | $ 1,000 | ||||||||||||
Conversion price | $ 0.20 | ||||||||||||
Preferred Stock, convertible, shares issuable | 24,250,000 | ||||||||||||
2020 Shelf Registration Statement | Series A Warrants | |||||||||||||
Subsequent Event [Line Items] | |||||||||||||
Common stock that can be purchased with warrants (in shares) | 24,250,000 | ||||||||||||
2020 Shelf Registration Statement | Series B Warrants | |||||||||||||
Subsequent Event [Line Items] | |||||||||||||
Common stock that can be purchased with warrants (in shares) | 24,250,000 | ||||||||||||
2020 Shelf Registration Statement | Series A Preferred Stock | |||||||||||||
Subsequent Event [Line Items] | |||||||||||||
Issuance of common stock (in shares) | 2,425 | ||||||||||||
2020 Shelf Registration Statement | Series B Preferred Stock | |||||||||||||
Subsequent Event [Line Items] | |||||||||||||
Issuance of common stock (in shares) | 2,425 | ||||||||||||
Private Placement | Common stock | |||||||||||||
Subsequent Event [Line Items] | |||||||||||||
Issuance of common stock (in shares) | 8,426,750 | 8,426,750 | |||||||||||
Share price (in dollars per share) | $ 0.93 | ||||||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 7,800,000 | ||||||||||||
At-the-market sales | Common stock | |||||||||||||
Subsequent Event [Line Items] | |||||||||||||
Issuance of common stock (in shares) | 6,915,151 | 12,242,436 | |||||||||||
At Market Sales on January 23 | |||||||||||||
Subsequent Event [Line Items] | |||||||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 2,500,000 | ||||||||||||
At Market Sales on January 23 | Common stock | |||||||||||||
Subsequent Event [Line Items] | |||||||||||||
Issuance of common stock (in shares) | 1,801,528 | ||||||||||||
At Market Sales on November 8 | |||||||||||||
Subsequent Event [Line Items] | |||||||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 19,300,000 | ||||||||||||
At Market Sales on November 8 | Common stock | |||||||||||||
Subsequent Event [Line Items] | |||||||||||||
Issuance of common stock (in shares) | 10,440,908 | ||||||||||||
At Market Sales on March 18 | Common stock | |||||||||||||
Subsequent Event [Line Items] | |||||||||||||
Issuance of common stock (in shares) | 6,915,151 | ||||||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 9,300,000 | ||||||||||||
Public offering | |||||||||||||
Subsequent Event [Line Items] | |||||||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 21,081,000 | $ 48,434,000 | $ 12,687,000 | ||||||||||
Public offering | Common stock | |||||||||||||
Subsequent Event [Line Items] | |||||||||||||
Issuance of common stock (in shares) | 26,666,648 | 17,250,000 | 14,526,315 | 26,666,648 | 17,250,000 | 14,526,315 | |||||||
Common stock that can be purchased with warrants (in shares) | 13,333,324 | ||||||||||||
Share price (in dollars per share) | $ 0.85 | $ 3 | $ 0.95 | ||||||||||
Common stock that can be purchased with one-half of warrant (in shares) | 1 | ||||||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 21,100,000 | $ 48,400,000 | $ 12,700,000 | ||||||||||
Subsequent event | |||||||||||||
Subsequent Event [Line Items] | |||||||||||||
Common Stock, Shares Authorized | 300,000,000 | 150,000,000 | |||||||||||
Subsequent event | Perceptive Credit Agreement | |||||||||||||
Subsequent Event [Line Items] | |||||||||||||
Repayments of Debt | $ 5,000,000 | ||||||||||||
Debt Instrument, Prepayment Premium Due | $ 0 | ||||||||||||
Subsequent event | Series A Warrants | Securities Purchase Agreement | |||||||||||||
Subsequent Event [Line Items] | |||||||||||||
Common stock that can be purchased with warrants (in shares) | 24,250,000 | ||||||||||||
Warrants and rights outstanding, term | 5 years | ||||||||||||
Stock stated value | $ 1,000 | ||||||||||||
Conversion price | $ 0.20 | ||||||||||||
Preferred Stock, convertible, shares issuable | 24,250,000 | ||||||||||||
Exercisable term | 6 months | ||||||||||||
Exercise price of warrants (in dollars per share) | $ 0.26 | ||||||||||||
Subsequent event | Series B Warrants | Securities Purchase Agreement | |||||||||||||
Subsequent Event [Line Items] | |||||||||||||
Warrants and rights outstanding, term | 1 year 6 months | ||||||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 4,900,000 | ||||||||||||
Exercisable term | 6 months | ||||||||||||
Exercise price of warrants (in dollars per share) | $ 0.26 | ||||||||||||
Subsequent event | Series A Preferred Stock | Securities Purchase Agreement | |||||||||||||
Subsequent Event [Line Items] | |||||||||||||
Issuance of common stock (in shares) | 2,425 | ||||||||||||
Subsequent event | Series B Preferred Stock | Securities Purchase Agreement | |||||||||||||
Subsequent Event [Line Items] | |||||||||||||
Issuance of common stock (in shares) | 2,425 |