Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Feb. 24, 2021 | Jun. 30, 2020 | |
Document and Entity Information | |||
Entity Registrant Name | AGILE THERAPEUTICS INC | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2020 | ||
Title of 12(g) 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 | $ 196.8 | ||
Entity Common Stock, Shares Outstanding | 87,628,904 | ||
Entity Central Index Key | 0001261249 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 14,463 | $ 34,479 |
Marketable securities | 40,008 | |
Accounts receivable, net | 865 | |
Prepaid expenses | 1,449 | 840 |
Total current assets | 56,785 | 35,319 |
Property and equipment, net | 14,243 | 14,044 |
Right of use asset | 138 | 158 |
Other non-current assets | 1,896 | 19 |
Total assets | 73,062 | 49,540 |
Current liabilities: | ||
Accounts payable | 3,867 | 1,819 |
Accrued expenses | 3,348 | 1,804 |
Lease liability, current portion | 138 | 172 |
Total current liabilities | 7,353 | 3,795 |
Long-term debt | 16,381 | |
Total liabilities | 23,734 | 3,795 |
Commitments and contingencies (Note 13) | ||
Stockholders' equity | ||
Common stock, $.0001 par value, 150,000,000 shares authorized, 87,563,753 and 69,810,305 issued and outstanding at December 31, 2020 and December 31, 2019, respectively | 9 | 7 |
Additional paid-in capital | 361,539 | 306,108 |
Accumulated other comprehensive income | 3 | |
Accumulated deficit | (312,223) | (260,370) |
Total stockholders’ equity | 49,328 | 45,745 |
Total liabilities and stockholders’ equity | $ 73,062 | $ 49,540 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
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) | 87,563,753 | 69,810,305 |
Common stock, outstanding (in shares) | 87,563,753 | 69,810,305 |
Statements of Operations
Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Statements of Operations | |||
Revenues, net | $ 749 | ||
Cost of product revenues | 282 | ||
Gross profit | 467 | ||
Operating expenses: | |||
Research and development | 13,500 | $ 9,858 | $ 9,777 |
Selling and marketing | 23,285 | 1,085 | 942 |
General and administrative | 12,735 | 7,915 | 7,797 |
Restructuring costs | 1,019 | ||
Total operating expenses | 49,520 | 18,858 | 19,535 |
Loss from operations | (49,053) | (18,858) | (19,535) |
Other income (expense) | |||
Interest income | 309 | 252 | 366 |
Interest expense | (3,109) | (1,116) | |
Change in fair value of warrants | 29 | ||
Total other income (expense), net | (2,800) | 252 | (721) |
Loss before benefit from income taxes | (51,853) | (18,606) | (20,256) |
Benefit from income taxes | 477 | ||
Net loss | $ (51,853) | $ (18,606) | $ (19,779) |
Net loss per share (basic and diluted) (in dollars per share) | $ (0.61) | $ (0.38) | $ (0.58) |
Weighted-average common shares (basic and diluted) (in shares) | 84,683,084 | 49,432,487 | 34,315,931 |
Comprehensive loss: | |||
Net loss | $ (51,853) | $ (18,606) | $ (19,779) |
Other comprehensive income: | |||
Unrealized gain on marketable securities | 3 | ||
Comprehensive loss | $ (51,850) | $ (18,606) | $ (19,779) |
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 CapitalPublic offering | Additional Paid-in CapitalPrivate Placement | Additional Paid-in CapitalAt-the-market sales | Additional Paid-in CapitalCumulative Effect, Period of Adoption, Adjustment [Member] | Additional Paid-in Capital | Accumulated Other Comprehensive Income | Accumulated DeficitCumulative Effect, Period of Adoption, Adjustment [Member] | Accumulated Deficit | Public offering | Private Placement | At-the-market sales | Total |
Balance at Dec. 31, 2017 | $ 3 | $ 258,092 | $ (221,772) | $ 36,323 | ||||||||||||
Balance (in shares) at Dec. 31, 2017 | 34,186,342 | |||||||||||||||
Increase (decrease) in stockholders' equity | ||||||||||||||||
Share-based compensation - stock options and RSUs | 3,630 | 3,630 | ||||||||||||||
Vesting of RSUs (in shares) | 190,987 | |||||||||||||||
Net loss | (19,779) | (19,779) | ||||||||||||||
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 | |||||||||||||
Vesting of RSUs (in shares) | 145,204 | |||||||||||||||
Issuance of common stock upon exercise of options | 164 | 164 | ||||||||||||||
Issuance of common stock upon exercise of options (in shares) | 92,271 | |||||||||||||||
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 | |||||||||||||||
Vesting of RSUs | 3 | |||||||||||||||
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 | ||||||||||||||
Net loss | $ 0 | 0 | (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 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Cash flows from operating activities: | |||
Net loss | $ (51,853) | $ (18,606) | $ (19,779) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 105 | 18 | 23 |
Amortization | 171 | 145 | |
Noncash stock-based compensation | 2,818 | 1,762 | 3,630 |
Noncash interest | 1,341 | 282 | |
Change in fair value of warrants | (29) | ||
Changes in operating assets and liabilities: | |||
Accounts receivable | (865) | ||
Prepaid expenses and other assets | (2,485) | (233) | 155 |
Accounts payable and accrued expenses | 3,641 | 1,377 | (1,177) |
Lease liability | (184) | (152) | |
Net cash used in operating activities | (47,311) | (15,689) | (16,895) |
Cash flows from investing activities: | |||
Purchases of marketable securities | (54,837) | ||
Sales and maturities of marketable securities | 14,500 | ||
Acquisition of property and equipment | (353) | (98) | (318) |
Net cash used in investing activities | (40,690) | (98) | (318) |
Cash flows from financing activities: | |||
Proceeds from issuance of long-term debt | 20,000 | ||
Principal payments of long-term debt | (10,888) | ||
Debt financing costs paid | (1,059) | ||
Proceeds from issuance of common stock in private placement, net of offering costs | (7,810) | ||
Proceeds from exercise of stock options | 610 | 164 | |
Net cash provided by financing activities | 67,985 | 42,415 | (10,888) |
Net (decrease) increase in cash and cash equivalents | (20,016) | 26,628 | (28,101) |
Cash and cash equivalents, beginning of period | 34,479 | 7,851 | 35,952 |
Cash and cash equivalents, end of period | 14,463 | 34,479 | 7,851 |
Supplemental disclosure of noncash financing activities | |||
Warrants issued in connection with long-term debt | 3,570 | ||
Supplemental cash flow information | |||
Interest paid | 2,099 | $ 1,370 | |
Non-cash transactions | |||
Property and equipment purchases included in accounts payable | 49 | ||
At-the-market sales | |||
Cash flows from financing activities: | |||
Proceeds from issuance of common stock in public offering, net of offering costs | 21,754 | ||
Public offering | |||
Cash flows from financing activities: | |||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 48,434 | $ 12,687 |
Organization and Description of
Organization and Description of Business | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020, the Company had an accumulated deficit of approximately $312 million. The Company expects to continue to incur significant expenses and increased operating losses for the foreseeable future and that its operating expenses will increase substantially in connection with its ongoing activities, as the Company: · maintains a sales and marketing infrastructure to commercialize 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, 2020, the Company had cash, cash equivalents and marketable securities of $54.5 million. The Company believes that its cash, cash equivalents and marketable securities as of December 31, 2020 will be sufficient to meet its projected operating requirements through the end of 2021. The Company will require additional capital to fund its operating needs beyond 2021, which primarily will include commercializing 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 and anticipates it will continue to incur net losses for the foreseeable future. The Company’s ability to continue operations beyond 2021 will depend on its ability to obtain additional capital, 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 complete 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, 2020 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, 2020 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, 2020 | |
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. Certain reclassifications have been made to prior periods to conform with current reporting. On the balance sheet, our right of use asset has been stated separately from other non-current assets. On the statement of operations, the Company has separated the presentation of selling and marketing expenses from the total general and administrative expenses in the current period. To conform prior year amounts to the current period presentation, totals of $1.1 million and $0.9 million were reclassified from general and administrative expenses to selling and marketing expenses for the years ended December 31, 2019 and 2018, respectively. 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, the accounting for common stock warrants, stock‑based compensation, income taxes, 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. While it is unknown how long these conditions will last and what the complete effect will be on the Company, to date, the Company has been able to continue to execute on its plans according to the related timelines. 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, as Twirla was commercially launched in December 2020 and historical data is not yet available. The credit loss reserves are reviewed and adjusted periodically. 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 , disclosures of fair value information about financial instruments are required, whether or not recognized in the balance sheet, for which it is practicable to estimate that value. Cash, cash equivalents, and marketable securities are carried at fair value (see Note 3). 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 and planned production. Management does not believe the Company’s inventory is subject to significant risk of obsolescence in the near term. The Company’s third-party manufacturer, Corium, has completed the validation of the commercial manufacturing process for Twirla. The costs associated with validation batches were expensed as research and development expenses during the period the costs were incurred. The Company is using this validation product for commercial supplies and samples of Twirla. Since the Company did not capitalize any validation product, all sales of this validation product will have no product cost associated with it. During the year ended December 31, 2020, the cost basis of product sold that had a carrying value of zero was approximately $0.1 million. Had such inventory been valued at acquisition cost, it would have resulted in an increase in cost of goods sold and a decrease in gross profit. The Company expects inventories with a carrying value of zero to be utilized in 2021. All future production of commercial supplies will be capitalized as inventory. Property and Equipment Property and equipment, consisting of 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. Currently, all fixed assets pertain to production equipment at the Company’s third party manufacturing partner and have an estimated useful life of 7 years. 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 , the Company’s policy is to review long‑lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Management does not believe that there has been any impairment of the carrying value of any long‑lived assets as of December 31, 2020. 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 $5.5 million and $0 for the years ended December 31, 2020 and 2019, respectively. 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 $231, $0 and $133 for the years ended December 31, 2020, 2019 and 2018, 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 recognized any losses from credit risks on such accounts. The Company mitigates credit risk by limiting the investment type and maturity to securities that preserve capital, maintain liquidity and have a high credit quality. The Company has no financial instruments with off balance sheet risk of accounting loss. Major customers of the Company are defined as those constituting greater than 10% of its total revenue. In 2020, the Company had sales to three customers that individually accounted for more than 10% of our total revenue. These customers had sales of $0.3 million, $0.2 million, and $0.2 million, respectively, which represented 97% of total revenues in the aggregate. Accounts receivable related to these major customers comprised 35%, 32%, and 30%, respectively. Revenue Recognition The Company recognizes revenue from the sale of its product, Twirla, in accordance with ASC 606, Revenue from Contracts with Customers (ASC 606). The provisions of ASC 606 require the following steps to determine revenue recognition: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation. 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 s – The Company incentivizes its customers to pay their invoices on time through prompt pay discounts. These discounts are an industry standard practice and the Company offers a prompt pay discount to each wholesale distributor customer. The specific prompt pay terms vary by customer and are contractually fixed. Prompt pay discounts are typically taken by the Company’s customers, so an estimate of the discount is recorded at the time of sale based on the WAC. Prompt pay discount estimates are recorded as contra trade accounts receivable on the balance sheet. 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 – Customers have the right to return product that is within six months or less of the labeled expiration date or that is past the expiration date by no more than twelve months. Twirla was commercially launched in December 2020 and there were no returns as of December 31, 2020. As time passes and historical data becomes available, the Company will begin to use historical sales and return data to estimate future product returns. Chargebacks – Certain government entities and covered entities will be able to purchase the product at a price discounted below WAC. The Company is currently in the process of finalizing agreements with these types of entities. The difference between the government or covered entity purchase price and the wholesale distributor purchase price of WAC will be charged back to the Company. The Company estimates the amount in chargebacks based on the expected number of claims and related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Estimated chargebacks are recorded as contra trade accounts receivable on the balance sheet. Rebates – The Company will be subject to mandatory discount obligations under the Medicaid and Tricare programs. The Company is currently in the process of finalizing these agreements with Medicaid and Tricare. The rebate amounts for these programs are determined by statutory requirements or contractual arrangements. Rebates are owed after the product has been dispensed to an end user and the Company has been invoiced. Rebates for Medicaid and Tricare are typically invoiced in arrears. The Company estimates the amount in rebates based on the expected number of claims and related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Rebate estimates are recorded as other current liabilities on the balance sheet. Co-payment assistance - The Company offers a co-payment assistance program to commercially insured patients whose insurance requires a co-payment to be made when filling their prescription. This is a voluntary program that is intended to provide financial assistance to patients meeting certain eligibility requirements. The Company estimates the amount of co-payment assistance based on the expected number of claims and related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Co-payment assistance estimates are recorded as other current liabilities on the balance sheet. The following table provides a summary of the Company’s sales allowances and related accruals for the year ended December 31, 2020 which have been deducted in arriving at revenues, net. December 31, Allowances for Payments & December 31, 2019 current period sales credits 2020 Customer credits, discounts and allowances $ — $ 187 $ — $ 187 Rebates and co-pay assistance — 116 — 116 Total $ — $ 303 $ — $ 303 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, which indicate that a down round feature no longer precludes equity classification when assessing whether an investment is indexed to an entity’s own stock. The Company used a modified retrospective approach to adoption, which does not restate its financial statements as of the prior year end (December 31, 2018). The cumulative effect of adoption of ASU 2017-11 resulted in an adjustment to accumulated deficit as of January 1, 2019 of $213 with a corresponding adjustment to additional paid-in capital. Warrants to purchase 62,505 shares of common stock at $6.00 per share expired on December 14, 2019, and none of these warrants are outstanding as of December 31, 2020. The warrants issued in connection with the Company’s debt financing completed in February 2015 are classified as a component of stockholders’ equity. The value of such warrants was determined using the Black-Scholes option-pricing model. These warrants expired without being exercised on February 24, 2020. 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. These warrant instruments qualify for equity classification and have been allocated based upon the relative fair value of the base instrument and the warrant. See Note 9 for additional information. Income Taxes The Company accounts for deferred taxes using the asset and liability method as specified by ASC 740, Income Taxes . Deferred income tax assets and liabilities are determined based on differences between the financial statement reporting and the tax basis of assets and liabilities, operating losses and tax credit carryforwards. Deferred income taxes are measured using the enacted tax rates and laws that are anticipated to be in effect when the differences are expected to reverse. The measurement of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized. The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted. The Company has adopted the authoritative guidance on accounting for and disclosure of uncertainty in tax positions which prescribes a comprehensive model for the financial statement recognition, measurement, presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns. The Company has no uncertain tax positions as of December 31, 2020 that qualify for either recognition or disclosure in the financial statements under this guidance. Stock‑Based Compensation The Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation . The Company grants stock options for a fixed number of shares to employees and non-employees with an exercise price equal to the fair value of the shares at grant date. Compensation cost is recognized for all share-based payments granted and is based on the grant-date fair value estimated using the weighted-average assumption of the Black-Scholes option pricing model based on key assumptions such as stock price, expected volatility and expected term. The Company elects to account for forfeitures when they occur. The equity instrument is not considered to be issued until the instrument vests. As a result, compensation cost is recognized over the requisite service period with an offsetting credit to additional paid-in capital. The Company also awards restricted stock units (“RSUs”) to employees and its board of directors. RSUs are generally subject to forfeiture if employment terminates prior to the completion of the vesting restrictions. The Company expenses the cost of the RSUs, which is determined to be the fair market value of the shares of common stock underlying the RSUs at the date of grant, ratably over the period during which the vesting restrictions lapse. 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, 2020, 2019 and 2018, respectively, because to do so would be anti-dilutive (in common equivalent shares): Year Ended December 31, 2020 2019 2018 Common stock warrants 1,400,000 180,274 242,779 Unvested restricted stock units 159,795 — 147,554 Common stock options 8,519,086 7,192,357 5,687,901 Total 10,078,881 7,372,631 6,078,234 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. This ASU eliminates the requirement to consider “down round” features when determining whether certain equity-linked financial instruments or embedded features are indexed to an entity’s own stock. On January 1, 2019, the Company adopted the provisions of ASU No. 2017-11 using a modified retrospective approach, which does not restate its financial statements as of the prior year end (December 31, 2018). The cumulative effect of adoption of ASU 2017-11 resulted in an adjustment to accumulated deficit as of January 1, 2019 of $213 with a corresponding adjustment to 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. The Company applied the new credit standard to these transactions resulting in an immaterial allowance for credit losses at December 31, 2020. 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. 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, 2020 | |
Fair Value Measurements | |
Fair Value Measurements | 3. Fair Value Measurements ASC 820, Fair Value Measurements and Disclosures , describes the fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value. 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 participant 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, 2020 and 2019: 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 $ — Level 1 Level 2 Level 3 December 31, 2019 Assets: Cash and cash equivalents $ 34,479 $ — $ — Total assets at fair value $ 34,479 $ — $ — There were no transfers between Level 1, 2 or 3 during 2020 or 2019. |
Marketable Securities
Marketable Securities | 12 Months Ended |
Dec. 31, 2020 | |
Marketable Securities | |
Marketable Securities | 4. Marketable Securities The following is a 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 The Company holds investment-grade marketable securities. There were no continuous unrealized loss positions in excess of twelve months as of December 31, 2020. Marketable securities include $0.1 million of accrued interest income at December 31, 2020. |
Prepaid Expenses
Prepaid Expenses | 12 Months Ended |
Dec. 31, 2020 | |
Prepaid Expenses | |
Prepaid Expenses | 5. Prepaid Expenses Prepaid expenses consist of the following: December 31, December 31, 2020 2019 Prepaid insurance $ 680 $ 656 Other 769 184 Total prepaid expenses $ 1,449 $ 840 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2020 | |
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 2020 2019 Life Office equipment $ — $ 49 Computer equipment — 179 Manufacturing equipment 14,328 14,203 7 years 14,328 14,431 Less: accumulated depreciation (85) (387) Property and equipment $ 14,243 $ 14,044 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, 2020 | |
Accrued Liabilities | |
Accrued Liabilities | 7. Accrued Liabilities Accrued liabilities consist of the following: December 31, December 31, 2020 2019 Employee bonuses $ 1,697 $ 1,437 Accrued professional fees and other 1,651 367 Total accrued liabilities $ 3,348 $ 1,804 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2020 | |
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 recorded a lease asset and lease liability of approximately $0.3 million on its balance sheet as of January 1, 2019, with no impact on its statement of operations. The Company has no finance leases and one operating lease for office space in Princeton, NJ. On November 11, 2020, the Company entered into an extension for this location through December 31, 2021 and simultaneously reduced the amount of space it was leasing. Operating lease expense was $190 and $193 for the years ended December 31, 2020 and 2019, respectively. Operating cash flows used for operating leases during the years ended December 31, 2020 and 2019 were $184 and $152, respectively. As of December 31, 2020, the weighted-average remaining lease term was 1.0 years and the weighted average discount rate was 15.2%. Future minimum lease payments under non-cancellable leases as of December 31, 2020 were as follows: 2021 $ 150 Total $ 150 Less: Interest (12) Present value of lease liability $ 138 |
Credit Agreement and Guaranty
Credit Agreement and Guaranty | 12 Months Ended |
Dec. 31, 2020 | |
Credit Agreement and Guaranty | |
Credit Agreement and Guaranty | 9. Credit Agreement and Guaranty On February 10, 2020 (the “Closing Date”), the Company entered into a Credit Agreement and Guaranty with Perceptive Credit Holdings III, LP, a related party (“Perceptive”), for a senior secured term loan credit facility of up to $35.0 million, (the “Perceptive Credit Agreement”). A first tranche of $5.0 million was funded on execution of the Perceptive Credit Agreement. A second tranche of $15.0 million was funded as a result of the approval of Twirla by the FDA. Another $15.0 million tranche will be available to the Company based on the achievement of certain revenue milestones. On February 26, 2021 the Perceptive Credit Agreement was amended (“Amended Perceptive Credit Agreement”) to increase the total amount available to the Company to $45.0 million by creating a fourth tranche of $10.0 million that will be available based on the achievement of a revenue milestone. 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 Amended Perceptive Credit Agreement will accrue interest at an annual rate equal to the London Interbank Offered Rate for one-month deposits (“LIBOR”) plus 10.25%, provided that LIBOR shall not be less than 1.5%. The rate of interest in effect as of the Closing Date and at December 31, 2020 was 11.75%. Upon the occurrence and during the continuance of any event of default under the Amended Perceptive Credit Agreement, 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 10.0% if such prepayment occurs on or prior to February 10, 2021; 8.0% if such prepayment occurs after February 10, 2021 and 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. All of the Company’s obligations under the Amended Perceptive Credit Agreement are secured by a first-priority lien and security interest in substantially all of the Company’s tangible and intangible assets, including intellectual property. The Amended Perceptive Credit Agreement contains certain representations and warranties, affirmative covenants, negative covenants and conditions that are customary for similar financings. The negative covenants restrict or limit the ability of the Company to, among other things and subject to certain exceptions contained in the Perceptive Credit Agreement, incur new indebtedness; create liens on assets; engage in certain fundamental corporate changes, such as mergers or acquisitions, or changes to the Company’s business activities; make certain investments or restricted payments (each as defined in the 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 June 30, 2021, report revenues for the trailing 12-month period that exceed the amounts set forth in the Amended Perceptive Credit Agreement, which range from $3.8 million for the fiscal quarter ending June 30, 2021 to $87.1 million for the fiscal quarter ending December 31, 2023. The Company received a covenant waiver 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 Amended Perceptive Credit Agreement as of December 31, 2020. 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. 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, 2020 Notes payable $ 20,000 Debt issuance costs (828) Warrant discount (2,791) Long-term debt $ 16,381 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2020 | |
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. 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. 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. 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. |
Equity Incentive Plans
Equity Incentive Plans | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020, there were 1,980,203 shares available for future grant under the Amended 2014 Plan. Through December 31, 2020, the Company granted options to certain employees and nonemployees to purchase shares of common stock at exercise prices ranging from $0.60 to $10.75 per share. The Company recorded noncash stock-based compensation expense for the years ended December 31, 2020, 2019 and 2018 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, 2020 2019 2018 Cost of goods sold $ 14 $ — $ — Research and development 651 522 1,274 General and administrative 2,153 1,240 2,356 Total $ 2,818 $ 1,762 $ 3,630 The following assumptions were used to compute employee stock‑based compensation under the Black‑Scholes option pricing model: 2020 2019 2018 Risk‑free interest rate .40% - 1.68 % 1.74% ‑ 2.61 % 2.57 % Expective volatility 65% ‑ 106 % 65 % 70 % 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. The Company has elected to record forfeitures as they occur. As of December 31, 2020, the unrecorded deferred stock‑based compensation balance related to stock options was approximately $4.0 million and will be recognized over an estimated weighted‑average amortization period of 2.8 years. The weighted average grant date fair value of options granted during the year ended December 31, 2020 was $1.70. The following table summarizes the options outstanding, options vested and the options exercisable as of December 31, 2020, 2019 and 2018: Weighted Weighted Average Average Remaining Exercise Contractual Aggregate Options Price Life (Years) Intrinsic Value Options outstanding at December 31, 2018 5,687,901 4.34 7.4 Options granted 2,805,600 1.18 Options exercised (92,271) 1.78 Options cancelled/forfeited (1,208,873) 2.70 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 $ 6,153 Options exercisable at December 31, 2020 5,300,428 3.46 6.3 $ 5,086 Vested and expected to vest at December 31, 2020 8,519,086 $ 6,153 Intrinsic value in the tables was calculated as the difference between the Company's stock price at December 31, 2020, of $2.87 per share, and the exercise price, multiplied by the number of options. Restricted Stock Units During the year ended December 31, 2017, the Company granted a total of 247,694 RSUs to executive officers and directors of the Company. These RSUs vested ratably over a two-year period for the executive officers and on the one-year anniversary of the grant date for the directors. During the year ended December 31, 2018, the Company granted a total of 108,254 RSUs to executive officers of the Company representing payment for 2017 target bonuses. 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 52,651 RSUs to executive officers of the Company. These RSUs vest 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. As of December 31, 2020, the unrecorded deferred stock‑based compensation balance related to RSUs was approximately $0.2 million 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, 2020, and 2019: Weighted Average Aggregate Shares Grant Date Fair Value Intrinsic Value Restricted stock units outstanding at December 31, 2018 147,554 3.03 Vested (147,554) 3.03 $ 129 Restricted stock units outstanding at December 31, 2019 — — Granted 159,795 2.81 Restricted stock units outstanding at December 31, 2020 159,795 $ 458 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, 2020. |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Income | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 is summarized below: Unrealized Gain on Marketable Securities Balance December 31, 2019 $ — Other comprehensive income 3 Balance December 31, 2020 $ 3 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Taxes | |
Income Taxes | 13. Income Taxes On December 22, 2017, the then President of the United States signed into law an Act to provide for reconciliation pursuant to titles II and V of the concurrent resolution on the budget for fiscal year 2018 (commonly known as “the Tax Cuts and Jobs Act or the “TCJA”), which introduced a comprehensive set of tax reforms. The Tax Cuts and Jobs Act significantly revises U.S. tax law by, among other provisions, lowering the Company’s corporate tax rate from 34% to 21% and eliminating or reducing certain income tax deductions. In December 2017, in accordance with the SEC Staff Accounting Bulletin (“SAB”) 118–Income Tax Accounting Implications of 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, 2020, the Company had available net operating loss carryforwards (“NOLs”) of approximately $281.7 million for federal and $107.2 million for state income tax reporting purposes. Under the TCJA, the federal NOLs generated after 2017, approximately $84.0 million, can be carried forward indefinitely, while the NOLs generated through taxable years ending December 31, 2017, approximately $197.7 million, are available to offset future federal taxable income, if any, through 2037. The Company also has research and development tax credit carryforwards of approximately $6.5 million and $1.8 million for federal and state income tax reporting purposes, respectively, which are available to reduce federal income taxes, if any, through 2040 and state income taxes, if any, through 2035. 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, 2020, the Company has not accrued interest or penalties related to uncertain tax positions. The Company’s tax returns for the years ended December 31, 2017 through December 31, 2019 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, 2020, 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, 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 66,907 $ 55,216 Research credit carryforward 7,909 7,609 Stock options and other 1,962 3,225 Total gross deferred tax assets 76,778 66,050 Valuation allowance for deferred tax assets (76,778) (66,050) Net deferred tax assets $ — $ — The net change in the valuation allowance for the years ended December 31, 2020 and 2019 was an increase of $10.6 million and an increase of $5.3 million, respectively. A reconciliation of the U.S. statutory income tax rate to the Company’s effective tax rate is as follows: December 31, 2020 2019 2018 Federal income tax at statutory rate 21.0 % 21.0 % 21.0 % State income tax benefit, net of federal benefit 1.0 % 7.0 % 6.0 % Research and development tax credits 0.7 % 4.0 % 3.0 % Other (2.0) % (4.0) % (4.0) % Increase to valuation allowance (20.7) % (28.0) % (24.0) % Effective income tax rate 0.0 % 0.0 % 2.0 % 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. In January 2018, the Company completed the sale of NOLs totaling approximately $0.5 million. This amount is a current state tax benefit and is reflected in the statement of operations for the year ended December 31, 2018. 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 is currently evaluating the potential sale of NJ NOLs under this new threshold. |
2019 Retention Plan
2019 Retention Plan | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 | |
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 $16.3 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, 2020, the Company has not recorded a provision for any contingent losses. |
Subsequent Event
Subsequent Event | 12 Months Ended |
Dec. 31, 2020 | |
Subsequent Event [Abstract] | |
Subsequent Event | 16. Subsequent Event On February26, 2021, the Company entered into the Amended Perceptive Credit Agreement, which amends the Credit Agreement and Guarantee dated February 10, 2020 between the Company and Perceptive. The Amended Perceptive Credit Agreement increases the total amount of credit available to the Company under the Credit Agreement to $45.0 million by creating a fourth tranche of $10.0 million that will be available based on the achievement of a revenue milestone. The interest rate and 1% fee payable upon the drawing of a tranche set forth in the Credit Agreement will also apply to the fourth tranche created by the Amended Perceptive Credit Agreement. Perceptive will receive an additional warrant to purchase 450,000 shares of common stock in connection with entering into the Amended Perceptive Credit Agreement. |
Quarterly Data (Unaudited)
Quarterly Data (Unaudited) | 12 Months Ended |
Dec. 31, 2020 | |
Quarterly Data (Unaudited) | |
Quarterly Data (Unaudited) | 17. Quarterly Data (Unaudited) The following tables summarize the quarterly results of operations for each of the quarters in 2020 and 2019. These quarterly results are unaudited, but in the opinion of management, have been prepared on the same basis as our audited financial information and include all adjustments (consisting only of normal recurring adjustments) necessary for a fair presentation of the information set forth herein (in thousands, except per share amounts). March 31, June 30, September 30, December 31, 2020 2020 2020 2020 Total revenue $ — $ — $ — $ 749 Gross profit $ — $ — $ — $ 467 Operating expenses $ 7,617 $ 10,039 $ 14,656 $ 17,208 Net loss $ (7,883) $ (10,826) $ (15,524) $ (17,620) Basic and diluted net loss per common share $ (0.10) $ (0.12) $ (0.18) $ (0.20) March 31, June 30, September 30, December 31, 2019 2019 2019 2019 Total revenue $ — $ — $ — $ — Operating expenses $ 4,707 $ 3,547 $ 4,499 $ 6,105 Net loss $ (4,669) $ (3,484) $ (4,432) $ (6,021) Basic and diluted net loss per common share $ (0.13) $ (0.08) $ (0.08) $ (0.10) |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
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. Certain reclassifications have been made to prior periods to conform with current reporting. On the balance sheet, our right of use asset has been stated separately from other non-current assets. On the statement of operations, the Company has separated the presentation of selling and marketing expenses from the total general and administrative expenses in the current period. To conform prior year amounts to the current period presentation, totals of $1.1 million and $0.9 million were reclassified from general and administrative expenses to selling and marketing expenses for the years ended December 31, 2019 and 2018, respectively. |
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, the accounting for common stock warrants, stock‑based compensation, income taxes, 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. While it is unknown how long these conditions will last and what the complete effect will be on the Company, to date, the Company has been able to continue to execute on its plans according to the related timelines. 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, as Twirla was commercially launched in December 2020 and historical data is not yet available. The credit loss reserves are reviewed and adjusted periodically. 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 , disclosures of fair value information about financial instruments are required, whether or not recognized in the balance sheet, for which it is practicable to estimate that value. Cash, cash equivalents, and marketable securities are carried at fair value (see Note 3). 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 and planned production. Management does not believe the Company’s inventory is subject to significant risk of obsolescence in the near term. The Company’s third-party manufacturer, Corium, has completed the validation of the commercial manufacturing process for Twirla. The costs associated with validation batches were expensed as research and development expenses during the period the costs were incurred. The Company is using this validation product for commercial supplies and samples of Twirla. Since the Company did not capitalize any validation product, all sales of this validation product will have no product cost associated with it. During the year ended December 31, 2020, the cost basis of product sold that had a carrying value of zero was approximately $0.1 million. Had such inventory been valued at acquisition cost, it would have resulted in an increase in cost of goods sold and a decrease in gross profit. The Company expects inventories with a carrying value of zero to be utilized in 2021. All future production of commercial supplies will be capitalized as inventory. |
Property and Equipment | Property and Equipment Property and equipment, consisting of 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. Currently, all fixed assets pertain to production equipment at the Company’s third party manufacturing partner and have an estimated useful life of 7 years. 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 , the Company’s policy is to review long‑lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Management does not believe that there has been any impairment of the carrying value of any long‑lived assets as of December 31, 2020. |
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 $5.5 million and $0 for the years ended December 31, 2020 and 2019, respectively. |
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 $231, $0 and $133 for the years ended December 31, 2020, 2019 and 2018, 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 recognized any losses from credit risks on such accounts. The Company mitigates credit risk by limiting the investment type and maturity to securities that preserve capital, maintain liquidity and have a high credit quality. The Company has no financial instruments with off balance sheet risk of accounting loss. Major customers of the Company are defined as those constituting greater than 10% of its total revenue. In 2020, the Company had sales to three customers that individually accounted for more than 10% of our total revenue. These customers had sales of $0.3 million, $0.2 million, and $0.2 million, respectively, which represented 97% of total revenues in the aggregate. Accounts receivable related to these major customers comprised 35%, 32%, and 30%, respectively. |
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 (ASC 606). The provisions of ASC 606 require the following steps to determine revenue recognition: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation. 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 s – The Company incentivizes its customers to pay their invoices on time through prompt pay discounts. These discounts are an industry standard practice and the Company offers a prompt pay discount to each wholesale distributor customer. The specific prompt pay terms vary by customer and are contractually fixed. Prompt pay discounts are typically taken by the Company’s customers, so an estimate of the discount is recorded at the time of sale based on the WAC. Prompt pay discount estimates are recorded as contra trade accounts receivable on the balance sheet. 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 – Customers have the right to return product that is within six months or less of the labeled expiration date or that is past the expiration date by no more than twelve months. Twirla was commercially launched in December 2020 and there were no returns as of December 31, 2020. As time passes and historical data becomes available, the Company will begin to use historical sales and return data to estimate future product returns. Chargebacks – Certain government entities and covered entities will be able to purchase the product at a price discounted below WAC. The Company is currently in the process of finalizing agreements with these types of entities. The difference between the government or covered entity purchase price and the wholesale distributor purchase price of WAC will be charged back to the Company. The Company estimates the amount in chargebacks based on the expected number of claims and related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Estimated chargebacks are recorded as contra trade accounts receivable on the balance sheet. Rebates – The Company will be subject to mandatory discount obligations under the Medicaid and Tricare programs. The Company is currently in the process of finalizing these agreements with Medicaid and Tricare. The rebate amounts for these programs are determined by statutory requirements or contractual arrangements. Rebates are owed after the product has been dispensed to an end user and the Company has been invoiced. Rebates for Medicaid and Tricare are typically invoiced in arrears. The Company estimates the amount in rebates based on the expected number of claims and related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Rebate estimates are recorded as other current liabilities on the balance sheet. Co-payment assistance - The Company offers a co-payment assistance program to commercially insured patients whose insurance requires a co-payment to be made when filling their prescription. This is a voluntary program that is intended to provide financial assistance to patients meeting certain eligibility requirements. The Company estimates the amount of co-payment assistance based on the expected number of claims and related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Co-payment assistance estimates are recorded as other current liabilities on the balance sheet. The following table provides a summary of the Company’s sales allowances and related accruals for the year ended December 31, 2020 which have been deducted in arriving at revenues, net. December 31, Allowances for Payments & December 31, 2019 current period sales credits 2020 Customer credits, discounts and allowances $ — $ 187 $ — $ 187 Rebates and co-pay assistance — 116 — 116 Total $ — $ 303 $ — $ 303 |
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, which indicate that a down round feature no longer precludes equity classification when assessing whether an investment is indexed to an entity’s own stock. The Company used a modified retrospective approach to adoption, which does not restate its financial statements as of the prior year end (December 31, 2018). The cumulative effect of adoption of ASU 2017-11 resulted in an adjustment to accumulated deficit as of January 1, 2019 of $213 with a corresponding adjustment to additional paid-in capital. Warrants to purchase 62,505 shares of common stock at $6.00 per share expired on December 14, 2019, and none of these warrants are outstanding as of December 31, 2020. The warrants issued in connection with the Company’s debt financing completed in February 2015 are classified as a component of stockholders’ equity. The value of such warrants was determined using the Black-Scholes option-pricing model. These warrants expired without being exercised on February 24, 2020. 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. These warrant instruments qualify for equity classification and have been allocated based upon the relative fair value of the base instrument and the warrant. See Note 9 for additional information. |
Income Taxes | Income Taxes The Company accounts for deferred taxes using the asset and liability method as specified by ASC 740, Income Taxes . Deferred income tax assets and liabilities are determined based on differences between the financial statement reporting and the tax basis of assets and liabilities, operating losses and tax credit carryforwards. Deferred income taxes are measured using the enacted tax rates and laws that are anticipated to be in effect when the differences are expected to reverse. The measurement of deferred income tax assets is reduced, if necessary, by a valuation allowance for any tax benefits which are not expected to be realized. The effect on deferred income tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted. The Company has adopted the authoritative guidance on accounting for and disclosure of uncertainty in tax positions which prescribes a comprehensive model for the financial statement recognition, measurement, presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns. The Company has no uncertain tax positions as of December 31, 2020 that qualify for either recognition or disclosure in the financial statements under this guidance. |
Stock-Based Compensation | Stock‑Based Compensation The Company accounts for stock-based compensation in accordance with ASC 718, Compensation-Stock Compensation . The Company grants stock options for a fixed number of shares to employees and non-employees with an exercise price equal to the fair value of the shares at grant date. Compensation cost is recognized for all share-based payments granted and is based on the grant-date fair value estimated using the weighted-average assumption of the Black-Scholes option pricing model based on key assumptions such as stock price, expected volatility and expected term. The Company elects to account for forfeitures when they occur. The equity instrument is not considered to be issued until the instrument vests. As a result, compensation cost is recognized over the requisite service period with an offsetting credit to additional paid-in capital. The Company also awards restricted stock units (“RSUs”) to employees and its board of directors. RSUs are generally subject to forfeiture if employment terminates prior to the completion of the vesting restrictions. The Company expenses the cost of the RSUs, which is determined to be the fair market value of the shares of common stock underlying the RSUs at the date of grant, ratably over the period during which the vesting restrictions lapse. 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, 2020, 2019 and 2018, respectively, because to do so would be anti-dilutive (in common equivalent shares): Year Ended December 31, 2020 2019 2018 Common stock warrants 1,400,000 180,274 242,779 Unvested restricted stock units 159,795 — 147,554 Common stock options 8,519,086 7,192,357 5,687,901 Total 10,078,881 7,372,631 6,078,234 |
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. This ASU eliminates the requirement to consider “down round” features when determining whether certain equity-linked financial instruments or embedded features are indexed to an entity’s own stock. On January 1, 2019, the Company adopted the provisions of ASU No. 2017-11 using a modified retrospective approach, which does not restate its financial statements as of the prior year end (December 31, 2018). The cumulative effect of adoption of ASU 2017-11 resulted in an adjustment to accumulated deficit as of January 1, 2019 of $213 with a corresponding adjustment to 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. The Company applied the new credit standard to these transactions resulting in an immaterial allowance for credit losses at December 31, 2020. 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. 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, 2020 | |
Summary of Significant Accounting Policies | |
Summary of sales allowances and related accruals | The following table provides a summary of the Company’s sales allowances and related accruals for the year ended December 31, 2020 which have been deducted in arriving at revenues, net. December 31, Allowances for Payments & December 31, 2019 current period sales credits 2020 Customer credits, discounts and allowances $ — $ 187 $ — $ 187 Rebates and co-pay assistance — 116 — 116 Total $ — $ 303 $ — $ 303 |
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, 2020, 2019 and 2018, respectively, because to do so would be anti-dilutive (in common equivalent shares): Year Ended December 31, 2020 2019 2018 Common stock warrants 1,400,000 180,274 242,779 Unvested restricted stock units 159,795 — 147,554 Common stock options 8,519,086 7,192,357 5,687,901 Total 10,078,881 7,372,631 6,078,234 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 Assets: Cash and cash equivalents $ 14,463 $ — $ — Marketable securities — 40,008 — Total assets at fair value $ 14,463 $ 40,008 $ — Level 1 Level 2 Level 3 December 31, 2019 Assets: Cash and cash equivalents $ 34,479 $ — $ — Total assets at fair value $ 34,479 $ — $ — |
Marketable Securities (Tables)
Marketable Securities (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 2020 | |
Prepaid Expenses | |
Schedule of prepaid expenses | December 31, December 31, 2020 2019 Prepaid insurance $ 680 $ 656 Other 769 184 Total prepaid expenses $ 1,449 $ 840 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Property and Equipment | |
Schedule of components of property and equipment | December 31, Estimated 2020 2019 Life Office equipment $ — $ 49 Computer equipment — 179 Manufacturing equipment 14,328 14,203 7 years 14,328 14,431 Less: accumulated depreciation (85) (387) Property and equipment $ 14,243 $ 14,044 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accrued Liabilities | |
Schedule of accrued liabilities | December 31, December 31, 2020 2019 Employee bonuses $ 1,697 $ 1,437 Accrued professional fees and other 1,651 367 Total accrued liabilities $ 3,348 $ 1,804 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Leases | |
Maturity of lease liabilities | Future minimum lease payments under non-cancellable leases as of December 31, 2020 were as follows: 2021 $ 150 Total $ 150 Less: Interest (12) Present value of lease liability $ 138 |
Credit Agreement and Guaranty (
Credit Agreement and Guaranty (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Credit Agreement and Guaranty | |
Schedule of carrying amount of term loan | December 31, 2020 Notes payable $ 20,000 Debt issuance costs (828) Warrant discount (2,791) Long-term debt $ 16,381 |
Equity Incentive Plans (Tables)
Equity Incentive Plans (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Equity Incentive Plans | |
Schedule of stock-based compensation expense | Year Ended December 31, 2020 2019 2018 Cost of goods sold $ 14 $ — $ — Research and development 651 522 1,274 General and administrative 2,153 1,240 2,356 Total $ 2,818 $ 1,762 $ 3,630 |
Schedule of assumptions used to compute employee stock-based compensation | 2020 2019 2018 Risk‑free interest rate .40% - 1.68 % 1.74% ‑ 2.61 % 2.57 % Expective volatility 65% ‑ 106 % 65 % 70 % 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, 2018 5,687,901 4.34 7.4 Options granted 2,805,600 1.18 Options exercised (92,271) 1.78 Options cancelled/forfeited (1,208,873) 2.70 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 $ 6,153 Options exercisable at December 31, 2020 5,300,428 3.46 6.3 $ 5,086 Vested and expected to vest at December 31, 2020 8,519,086 $ 6,153 |
Schedule of restricted stock activity | Weighted Average Aggregate Shares Grant Date Fair Value Intrinsic Value Restricted stock units outstanding at December 31, 2018 147,554 3.03 Vested (147,554) 3.03 $ 129 Restricted stock units outstanding at December 31, 2019 — — Granted 159,795 2.81 Restricted stock units outstanding at December 31, 2020 159,795 $ 458 |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive Income (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
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, 2019 $ — Other comprehensive income 3 Balance December 31, 2020 $ 3 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Taxes | |
Schedule of tax effects of temporary differences that give rise to significant portions of deferred tax assets | December 31, 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 66,907 $ 55,216 Research credit carryforward 7,909 7,609 Stock options and other 1,962 3,225 Total gross deferred tax assets 76,778 66,050 Valuation allowance for deferred tax assets (76,778) (66,050) Net deferred tax assets $ — $ — |
Schedule of reconciliation of U.S. statutory income tax rate to effective tax rate | December 31, 2020 2019 2018 Federal income tax at statutory rate 21.0 % 21.0 % 21.0 % State income tax benefit, net of federal benefit 1.0 % 7.0 % 6.0 % Research and development tax credits 0.7 % 4.0 % 3.0 % Other (2.0) % (4.0) % (4.0) % Increase to valuation allowance (20.7) % (28.0) % (24.0) % Effective income tax rate 0.0 % 0.0 % 2.0 % |
Quarterly Data (Unaudited) (Tab
Quarterly Data (Unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Quarterly Data (Unaudited) | |
Summary of quarterly results of operations | These quarterly results are unaudited, but in the opinion of management, have been prepared on the same basis as our audited financial information and include all adjustments (consisting only of normal recurring adjustments) necessary for a fair presentation of the information set forth herein (in thousands, except per share amounts). March 31, June 30, September 30, December 31, 2020 2020 2020 2020 Total revenue $ — $ — $ — $ 749 Gross profit $ — $ — $ — $ 467 Operating expenses $ 7,617 $ 10,039 $ 14,656 $ 17,208 Net loss $ (7,883) $ (10,826) $ (15,524) $ (17,620) Basic and diluted net loss per common share $ (0.10) $ (0.12) $ (0.18) $ (0.20) March 31, June 30, September 30, December 31, 2019 2019 2019 2019 Total revenue $ — $ — $ — $ — Operating expenses $ 4,707 $ 3,547 $ 4,499 $ 6,105 Net loss $ (4,669) $ (3,484) $ (4,432) $ (6,021) Basic and diluted net loss per common share $ (0.13) $ (0.08) $ (0.08) $ (0.10) |
Organization and Description _2
Organization and Description of Business (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Nature of Operations | ||
Accumulated deficit | $ 312,223 | $ 260,370 |
Cash, cash equivalents and marketable securities | $ 54,500 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Basis of Presentation (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Summary of Significant Accounting Policies | |||
Selling and marketing | $ 23,285 | $ 1,085 | $ 942 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Inventory, Property and Equipment and Advertising Costs (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Inventory | $ 100 | |
Advertising costs | $ 5,500 | $ 0 |
Manufacturing equipment | ||
Estimated useful life (in years) | 7 years | 7 years |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Deferred Financing Costs (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Interest expense [Member] | |||
Deferred Financing Costs | |||
Amortization of deferred financing costs | $ 231 | $ 0 | $ 133 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Concentrations of Credit Risk (Details) $ in Thousands | 3 Months Ended | 12 Months Ended |
Dec. 31, 2020USD ($) | Dec. 31, 2020USD ($)customer | |
Concentration of risk, financial assets | ||
Financial instruments with off-balance sheet risk of accounting loss, assets | $ 0 | $ 0 |
Concentration risk, financial liabilities | ||
Financial instruments with off-balance sheet risk of accounting loss, liabilities | 0 | 0 |
Total revenue | $ 749 | $ 749 |
Customer Concentration Risk | ||
Concentration risk, financial liabilities | ||
Number of major customers | customer | 3 | |
Customer Concentration Risk | Sales Revenue | ||
Concentration risk, financial liabilities | ||
Concentration risk, percentage | 97.00% | |
Customer Concentration Risk | Sales Revenue | Customer One | ||
Concentration risk, financial liabilities | ||
Total revenue | $ 300 | |
Customer Concentration Risk | Sales Revenue | Customer Two | ||
Concentration risk, financial liabilities | ||
Total revenue | 200 | |
Customer Concentration Risk | Sales Revenue | Customer Three | ||
Concentration risk, financial liabilities | ||
Total revenue | $ 200 | |
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 | 32.00% | |
Customer Concentration Risk | Accounts Receivable | Customer Three | ||
Concentration risk, financial liabilities | ||
Concentration risk, percentage | 30.00% |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Co-Payment Assistance (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Accounts Receivable, Allowance for Credit Loss [Roll Forward] | |
Allowances for current period sales | $ 303 |
Accounts Receivable, Ending Balance | 303 |
Customer credits, discounts And allowances | |
Accounts Receivable, Allowance for Credit Loss [Roll Forward] | |
Allowances for current period sales | 187 |
Accounts Receivable, Ending Balance | 187 |
Rebates and co-pay assistance | |
Accounts Receivable, Allowance for Credit Loss [Roll Forward] | |
Allowances for current period sales | 116 |
Accounts Receivable, Ending Balance | $ 116 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Warrants (Details) - USD ($) $ / shares in Units, $ in Thousands | Dec. 31, 2020 | Feb. 29, 2020 | Dec. 31, 2019 | Dec. 14, 2019 | Jan. 01, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Warrants | |||||||
Cumulative effect adjustment | $ 49,328 | $ 45,745 | $ 20,174 | $ 36,323 | |||
Common stock warrants | |||||||
Warrants | |||||||
Common stock that can be purchased with warrants (in shares) | 1,400,000 | ||||||
Accumulated Deficit | |||||||
Warrants | |||||||
Cumulative effect adjustment | $ (312,223) | (260,370) | $ (241,551) | $ (221,772) | |||
ASU 2017-11 | Common stock warrants | Oxford Finance LLC | |||||||
Warrants | |||||||
Common stock that can be purchased with warrants (in shares) | 62,505 | ||||||
Number of warrants outstanding (in shares) | 0 | ||||||
Exercise price of warrants (in dollars per share) | $ 6 | ||||||
Cumulative Effect, Period of Adoption, Adjustment [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, 2020USD ($) |
Uncertainty in tax positions | |
Uncertain tax positions | $ 0 |
Summary of Significant Accou_11
Summary of Significant Accounting Policies - Segment Information (Details) | 12 Months Ended |
Dec. 31, 2020segment | |
Segment Information | |
Number of operating segments | 1 |
Number of reporting segments | 1 |
Summary of Significant Accou_12
Summary of Significant Accounting Policies - Net Loss Per Share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Anti-dilutive securities | |||
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 10,078,881 | 7,372,631 | 6,078,234 |
Common stock warrants | |||
Anti-dilutive securities | |||
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 1,400,000 | 180,274 | 242,779 |
Restricted Stock Units | |||
Anti-dilutive securities | |||
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 159,795 | 147,554 | |
Common stock options | |||
Anti-dilutive securities | |||
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 8,519,086 | 7,192,357 | 5,687,901 |
Summary of Significant Accou_13
Summary of Significant Accounting Policies - Recent Accounting Pronouncements (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 | Jan. 01, 2019 | Dec. 31, 2018 | Dec. 31, 2017 |
Recent Accounting Pronouncements | |||||
Cumulative effect adjustment | $ 49,328 | $ 45,745 | $ 20,174 | $ 36,323 | |
Accounts receivable, net | 865 | ||||
Twirla | |||||
Recent Accounting Pronouncements | |||||
Accounts receivable, net | 900 | ||||
Additional Paid-in Capital | |||||
Recent Accounting Pronouncements | |||||
Cumulative effect adjustment | $ 361,539 | 306,108 | $ 261,722 | $ 258,092 | |
Additional Paid-in Capital | Cumulative Effect, Period of Adoption, Adjustment [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, 2020 | Dec. 31, 2019 |
Level 1 | ||
Assets: | ||
Cash and cash equivalents | $ 14,463 | $ 34,479 |
Total assets at fair value | 14,463 | $ 34,479 |
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, 2020 | Dec. 31, 2019 | |
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) $ in Thousands | Dec. 31, 2020USD ($) |
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 |
Accrued interest | $ 100 |
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, 2020 | Dec. 31, 2019 |
Prepaid Expenses | ||
Prepaid insurance | $ 680 | $ 656 |
Other | 769 | 184 |
Total prepaid expenses | $ 1,449 | $ 840 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Property and Equipment | ||
Property and equipment, gross | $ 14,328 | $ 14,431 |
Less: accumulated depreciation | (85) | (387) |
Property and equipment, net | 14,243 | 14,044 |
Office equipment | ||
Property and Equipment | ||
Property and equipment, gross | 49 | |
Computer equipment | ||
Property and Equipment | ||
Property and equipment, gross | 179 | |
Manufacturing equipment | ||
Property and Equipment | ||
Property and equipment, gross | $ 14,328 | $ 14,203 |
Estimated Life (in years) | 7 years | 7 years |
Accrued Liabilities (Details)
Accrued Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Accrued Liabilities | ||
Employee bonuses | $ 1,697 | $ 1,437 |
Accrued professional fees and other | 1,651 | 367 |
Total accrued liabilities | $ 3,348 | $ 1,804 |
Leases - Summary (Details)
Leases - Summary (Details) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020USD ($)lease | Dec. 31, 2019USD ($) | Jan. 01, 2019USD ($) | |
Leases | |||
Lease assets | $ 138 | $ 158 | |
Present value of lease liability | $ 138 | ||
Number of finance leases | lease | 0 | ||
Number of operating leases | lease | 1 | ||
Operating lease expense | $ 190 | 193 | |
Operating lease expense information: | |||
Cash paid for amounts included in measurement of lease liabilities | $ 184 | $ 152 | |
Weighted-average remaining lease term (years) | 1 year | ||
Weighted-average discount rate | 15.20% | ||
ASU 2016-02 | Adjustment | |||
Leases | |||
Lease assets | $ 300 | ||
Present value of lease liability | $ 300 |
Leases - Maturity of lease liab
Leases - Maturity of lease liabilities (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Operating Leases | |
2021 | $ 150 |
Total | 150 |
Less: Interest | (12) |
Present value of lease liability | $ 138 |
Credit Agreement and Guaranty_2
Credit Agreement and Guaranty (Details) | Feb. 10, 2020USD ($)item$ / sharesshares | Feb. 26, 2021USD ($)shares | Dec. 31, 2023USD ($) | Mar. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Feb. 10, 2021shares |
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% | |||||
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 | $ 3,800,000 | ||||
Perceptive Credit Agreement | Perceptive Warrants | ||||||
Debt Instrument [Line Items] | ||||||
Common stock that can be purchased with warrants (in shares) | shares | 1,400,000 | |||||
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 | |||||
Common stock that can be purchased with warrants (in shares) | shares | 700,000 | |||||
Perceptive Credit Agreement | Remaining Seven Lakhs Shares | ||||||
Debt Instrument [Line Items] | ||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 4.67 | |||||
Common stock that can be purchased with warrants (in shares) | shares | 700,000 | |||||
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 | |||||
Subsequent Event | Perceptive Credit Agreement | Perceptive Warrants | ||||||
Debt Instrument [Line Items] | ||||||
Common stock that can be purchased with warrants (in shares) | shares | 450,000 | |||||
Subsequent Event | Perceptive Credit Agreement, Tranche Four | Perceptive Warrants | ||||||
Debt Instrument [Line Items] | ||||||
Common stock that can be purchased with warrants (in shares) | shares | 450,000 | |||||
Subsequent Event | Senior secured delayed draw term loan facility | Perceptive Credit Agreement | ||||||
Debt Instrument [Line Items] | ||||||
Maximum borrowing capacity | $ 45,000,000 | |||||
Subsequent Event | Senior secured delayed draw term loan facility | Perceptive Credit Agreement, Tranche Four | ||||||
Debt Instrument [Line Items] | ||||||
Maximum borrowing capacity | 45,000,000 | |||||
Amount borrowed | $ 10,000,000 | |||||
Interest rate (as a percent) | 1.00% | |||||
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, 2021 | Perceptive Credit Agreement | ||||||
Debt Instrument [Line Items] | ||||||
Prepayment fee percent | 10.00% | |||||
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) $ in Thousands | Dec. 31, 2020USD ($) |
Credit Agreement and Guaranty | |
Notes payable | $ 20,000 |
Debt issuance costs | (828) |
Warrant discount | (2,791) |
Total | $ 16,381 |
Stockholders' Equity - Amended
Stockholders' Equity - Amended and Restated Certificate of Incorporation (Details) | 12 Months Ended | |
Dec. 31, 2020classshares | Dec. 31, 2019shares | |
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 | Feb. 21, 2020 | Aug. 31, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Oct. 02, 2020 | Nov. 08, 2019 | Jan. 23, 2019 |
Sale of stock | ||||||||
Proceeds from issuance of common stock in private placement, net of offering costs | $ (7,810) | |||||||
2020 Shelf Registration Statement | ||||||||
Sale of stock | ||||||||
Aggregate amount of securities issuable | $ 200,000 | |||||||
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 | ||||||||
Sale of stock | ||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 21,754 | |||||||
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) | 12,242,436 | |||||||
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 | |||||||
Public offering | ||||||||
Sale of stock | ||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 48,434 | $ 12,687 | ||||||
Public offering | Common Stock | ||||||||
Sale of stock | ||||||||
Issuance of common stock (in shares) | 17,250,000 | 14,526,315 | 17,250,000 | 14,526,315 | ||||
Share price (in dollars per share) | $ 3 | $ 0.95 | ||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 48,400 | $ 12,700 |
Equity Incentive Plans - Stock
Equity Incentive Plans - Stock Options Summary (Details) - Common stock options | 12 Months Ended |
Dec. 31, 2020$ / sharesshares | |
Minimum | |
Equity Incentive Plans | |
Exercise prices of options granted through the end of the year (in dollars per share) | $ 0.60 |
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 | 1,980,203 |
Equity Incentive Plans - Stock-
Equity Incentive Plans - Stock-Based Compensation (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Equity Incentive Plans | |||
Total stock-based compensation expense | $ 2,818 | $ 1,762 | $ 3,630 |
Assumptions used to compute employee stock based compensation under the Black-Scholes option pricing model | |||
Risk-free interest rate (as a percent) | 2.57% | ||
Expected volatility (as a percent) | 65.00% | 70.00% | |
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) | 0.40% | 1.74% | |
Expected volatility (as a percent) | 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) | 1.68% | 2.61% | |
Expected volatility (as a percent) | 106.00% | ||
Common stock options | |||
Equity Incentive Plans | |||
Total stock-based compensation expense | $ 2,818 | $ 1,762 | $ 3,630 |
Unrecorded deferred stock-based compensation | |||
Unrecorded deferred stock-based compensation balance related to stock options | $ 4,000 | ||
Weighted-average amortization period over which cost is expected to be recognized | 2 years 9 months 18 days | ||
Weighted average grant date fair value of options granted (in dollars per share) | $ 1.70 | ||
Common stock options | Cost of goods sold | |||
Equity Incentive Plans | |||
Total stock-based compensation expense | $ 14 | ||
Common stock options | Research and development expense [Member] | |||
Equity Incentive Plans | |||
Total stock-based compensation expense | 651 | 522 | 1,274 |
Common stock options | General and administrative expenses | |||
Equity Incentive Plans | |||
Total stock-based compensation expense | 2,153 | $ 1,240 | $ 2,356 |
Restricted Stock Units | |||
Unrecorded deferred stock-based compensation | |||
Unrecorded deferred stock-based compensation balance related to stock options | $ 200 | ||
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 - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Options | |||
Options outstanding at beginning of year (in shares) | 7,192,357 | 5,687,901 | |
Options granted (in shares) | 2,539,403 | 2,805,600 | |
Options exercised (in shares) | (503,448) | (92,271) | |
Options cancelled/forfeited (in shares) | (709,226) | (1,208,873) | |
Options outstanding at end of year (in shares) | 8,519,086 | 7,192,357 | 5,687,901 |
Options exercisable at end of year (in shares) | 5,300,428 | ||
Vested and expected to vest at end of year (in shares) | 8,519,086 | ||
Weighted Average Exercise Price | |||
Options outstanding at beginning of year (in dollars per share) | $ 3.42 | $ 4.34 | |
Options granted (in dollars per share) | 2.80 | 1.18 | |
Options exercised (in dollars per share) | 1.21 | 1.78 | |
Options cancelled/forfeited (in dollars per share) | 6.20 | 2.70 | |
Options outstanding at end of year (in dollars per share) | 3.13 | $ 3.42 | $ 4.34 |
Options exercisable at end of year (in dollars per share) | 3.46 | ||
Vested and expected to vest at end of year (in dollars per share) | $ 0 | ||
Weighted Average Remaining Contractual Life (Years) | |||
Options outstanding | 7 years 3 months 18 days | 7 years 2 months 12 days | 7 years 4 months 24 days |
Options exercisable | 6 years 3 months 18 days | ||
Aggregate Intrinsic Value | |||
Options outstanding at the end of the year (in dollars) | $ 6,153 | ||
Options exercisable at the end of the year (in dollars) | 5,086 | ||
Vested and expected to vest at end of year | $ 6,153 | ||
Estimated stock price (in dollars per share) | $ 2.87 |
Equity Incentive Plans - Restri
Equity Incentive Plans - Restricted Stock (Details) - Restricted Stock Units - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Shares | |||
Restricted stock outstanding at beginning of year (in shares) | 147,554 | ||
Vested (in shares) | (159,795) | (147,554) | |
Restricted stock outstanding at end of year (in shares) | 159,795 | 147,554 | |
Weighted Average Grant Date Fair Value | |||
Restricted stock outstanding at beginning of year (in dollars per share) | $ 3.03 | ||
Vested (in dollars per share) | $ 2.81 | $ 3.03 | |
Restricted stock outstanding at end of year (in dollars per share) | $ 0 | $ 3.03 | |
Aggregate Intrinsic Value | |||
Intrinsic value of vested shares | $ 458 | $ 129 | |
Executive officers and directors | |||
Shares | |||
Granted (in shares) | 247,694 | ||
Executive officers | |||
Shares | |||
Granted (in shares) | 52,651 | 108,254 | |
Vesting period | 1 year | 1 year | 2 years |
Directors | |||
Shares | |||
Granted (in shares) | 107,144 | ||
Vesting period | 1 year | ||
Directors | Minimum | |||
Shares | |||
Vesting period | 1 year | ||
Directors | Maximum | |||
Shares | |||
Vesting period | 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, 2020 | 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) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Accumulated Other Comprehensive Income Loss Net Of Tax [Abstract] | |
Other comprehensive income of unrealized gain on marketable securities | $ 3 |
Balance at | $ 3 |
Income Taxes - Summary (Details
Income Taxes - Summary (Details) - USD ($) $ in Millions | 12 Months Ended | |||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
Income Taxes | ||||
Corporate tax rate (as a percent) | 21.00% | 21.00% | 21.00% | 34.00% |
Federal | Net Operating Losses | ||||
Income Taxes | ||||
Net operating loss carryforwards | $ 281.7 | $ 197.7 | ||
Indefinite net operating loss carryforward | 84 | |||
Federal | Research and Development | ||||
Income Taxes | ||||
Tax credit carryforwards | 6.5 | |||
State | Net Operating Losses | ||||
Income Taxes | ||||
Net operating loss carryforwards | 107.2 | |||
State | Research and Development | ||||
Income Taxes | ||||
Tax credit carryforwards | $ 1.8 |
Income Taxes - Deferred Taxes (
Income Taxes - Deferred Taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 66,907 | $ 55,216 |
Research credit carryforward | 7,909 | 7,609 |
Stock options and other | 1,962 | 3,225 |
Total gross deferred tax assets | 76,778 | 66,050 |
Valuation allowance for deferred tax assets | (76,778) | (66,050) |
Net deferred tax assets | 0 | 0 |
Valuation allowance | ||
Increase (decrease) in the valuation allowance | $ 10,600 | $ 5,300 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of U.S. Statutory Income Tax Rate to Effective Tax Rate (Details) | 12 Months Ended | |||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | |
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% | 34.00% |
State income tax benefit, net of federal benefit (as a percent) | 1.00% | 7.00% | 6.00% | |
Research and development tax credits (as a percent) | 0.70% | 4.00% | 3.00% | |
Other (as a percent) | (2.00%) | (4.00%) | (4.00%) | |
Increase to valuation allowance (as a percent) | (20.70%) | (28.00%) | (24.00%) | |
Effective income tax rate (as a percent) | 0.00% | 0.00% | 2.00% |
Income Taxes - Sale of New Jers
Income Taxes - Sale of New Jersey Net Operating Losses (Details) - Technology Business Tax Certificate Program - New Jersey - USD ($) $ in Millions | 1 Months Ended | |
Jan. 31, 2021 | Jan. 31, 2018 | |
Sale of New Jersey Net Operating Losses | ||
NOLs | $ 0.5 | |
Maximum lifetime benefit under the Program | $ 15 | |
Subsequent Event | ||
Sale of New Jersey Net Operating Losses | ||
Maximum lifetime benefit under the Program | $ 20 | |
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, 2020 | Feb. 29, 2020 |
2019 Retention Plan | |||
Cash portion of the retention plan | $ 0.3 | ||
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 January 2019 | Vesting on December 31, 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, 2020USD ($) |
Commitments and Contingencies | |
Future purchase commitments | $ 16.3 |
Subsequent Event (Details)
Subsequent Event (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Feb. 26, 2021 | Dec. 31, 2020 | Feb. 10, 2021 | Feb. 10, 2020 | |
Subsequent Event [Line Items] | ||||
Proceeds from Issuance of Long-term Debt | $ 20,000 | |||
Interest rate (as a percent) | 11.75% | 11.75% | ||
Perceptive Credit Agreement | Perceptive Warrants | ||||
Subsequent Event [Line Items] | ||||
Common stock that can be purchased with warrants (in shares) | 1,400,000 | |||
Senior secured delayed draw term loan facility | Perceptive Credit Agreement | ||||
Subsequent Event [Line Items] | ||||
Maximum borrowing capacity | $ 35,000 | |||
Subsequent Event | Perceptive Credit Agreement | Perceptive Warrants | ||||
Subsequent Event [Line Items] | ||||
Common stock that can be purchased with warrants (in shares) | 450,000 | |||
Subsequent Event | Perceptive Credit Agreement, Tranche Four | Perceptive Warrants | ||||
Subsequent Event [Line Items] | ||||
Common stock that can be purchased with warrants (in shares) | 450,000 | |||
Subsequent Event | Senior secured delayed draw term loan facility | Perceptive Credit Agreement | ||||
Subsequent Event [Line Items] | ||||
Maximum borrowing capacity | $ 45,000 | |||
Subsequent Event | Senior secured delayed draw term loan facility | Perceptive Credit Agreement, Tranche Four | ||||
Subsequent Event [Line Items] | ||||
Maximum borrowing capacity | 45,000 | |||
Proceeds from Issuance of Long-term Debt | $ 10,000 | |||
Interest rate (as a percent) | 1.00% |
Quarterly Data (Unaudited) - Qu
Quarterly Data (Unaudited) - Quarterly Results of Operations (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Quarterly Data (Unaudited) | |||||||||||
Total revenue | $ 749 | $ 749 | |||||||||
Gross profit | 467 | 467 | |||||||||
Operating expenses | 17,208 | $ 14,656 | $ 10,039 | $ 7,617 | $ 6,105 | $ 4,499 | $ 3,547 | $ 4,707 | 49,520 | $ 18,858 | $ 19,535 |
Net loss | $ (17,620) | $ (15,524) | $ (10,826) | $ (7,883) | $ (6,021) | $ (4,432) | $ (3,484) | $ (4,669) | $ (51,853) | $ (18,606) | $ (19,779) |
Basic and diluted net loss per common share (in dollars per share) | $ (0.20) | $ (0.18) | $ (0.12) | $ (0.10) | $ (0.10) | $ (0.08) | $ (0.08) | $ (0.13) | $ (0.61) | $ (0.38) | $ (0.58) |