Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2021 | Jul. 23, 2021 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 001-36464 | |
Entity Registrant Name | AGILE THERAPEUTICS INC | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 23-2936302 | |
Entity Address, Address Line One | 101 Poor Farm Road | |
Entity Address, City or Town | Princeton | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 08540 | |
City Area Code | 609 | |
Local Phone Number | 683-1880 | |
Title of 12(b) Security | Common stock | |
Trading Symbol | AGRX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 92,999,964 | |
Entity Central Index Key | 0001261249 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 26,118 | $ 14,463 |
Marketable securities | 4,999 | 40,008 |
Accounts receivable, net | 1,167 | 865 |
Inventory | 3,462 | |
Prepaid expenses and other current assets | 1,202 | 1,449 |
Total current assets | 36,948 | 56,785 |
Property and equipment, net | 13,363 | 14,243 |
Right of use asset | 72 | 138 |
Other non-current assets | 1,896 | 1,896 |
Total assets | 52,279 | 73,062 |
Current liabilities: | ||
Accounts payable | 6,410 | 3,867 |
Accrued expenses | 5,153 | 3,348 |
Lease liability, current portion | 72 | 138 |
Total current liabilities | 11,635 | 7,353 |
Long-term debt | 16,035 | 16,381 |
Total liabilities | 27,670 | 23,734 |
Commitments and contingencies (Note 12) | ||
Stockholders' equity | ||
Common stock, $.0001 par value, 150,000,000 shares authorized, 92,928,205 and 87,563,753 issued and outstanding at June 30, 2021 and December 31, 2020, respectively | 9 | 9 |
Additional paid-in capital | 371,588 | 361,539 |
Accumulated other comprehensive income | 3 | |
Accumulated deficit | (346,988) | (312,223) |
Total stockholders' equity | 24,609 | 49,328 |
Total liabilities and stockholders' equity | $ 52,279 | $ 73,062 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
Balance Sheets | ||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, authorized (in shares) | 150,000,000 | 150,000,000 |
Common stock, issued (in shares) | 92,928,205 | 87,563,753 |
Common stock, outstanding (in shares) | 92,928,205 | 87,563,753 |
Statements of Operations
Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Statements of Operations | ||||
Revenues, net | $ 1,185 | $ 1,301 | ||
Cost of product revenues | 1,145 | 2,306 | ||
Gross profit (loss) | 40 | (1,005) | ||
Operating expenses: | ||||
Research and development | 862 | $ 3,661 | 2,975 | $ 6,825 |
Selling and marketing | 11,714 | 3,150 | 20,877 | 4,892 |
General and administrative | 4,115 | 3,228 | 8,016 | 5,939 |
Total operating expenses | 16,691 | 10,039 | 31,868 | 17,656 |
Loss from operations | (16,651) | (10,039) | (32,873) | (17,656) |
Other income (expense) | ||||
Interest income | 7 | 115 | 23 | 247 |
Interest expense | (993) | (902) | (1,915) | (1,300) |
Total other income (expense), net | (986) | (787) | (1,892) | (1,053) |
Loss before benefit from income taxes | (17,637) | (10,826) | (34,765) | (18,709) |
Net loss | $ (17,637) | $ (10,826) | $ (34,765) | $ (18,709) |
Net loss per share (basic and diluted) (in dollars per share) | $ (0.20) | $ (0.12) | $ (0.39) | $ (0.23) |
Weighted-average common shares (basic and diluted) (in shares) | 88,693,968 | 87,221,441 | 88,162,929 | 81,936,815 |
Comprehensive loss: | ||||
Net loss | $ (17,637) | $ (10,826) | $ (34,765) | $ (18,709) |
Other comprehensive income: | ||||
Unrealized loss on marketable securities | 10 | (3) | 10 | |
Comprehensive loss | $ (17,637) | $ (10,816) | $ (34,768) | $ (18,699) |
Statements of Changes in Stockh
Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Common StockPublic offering | Common StockAt-the-market sales | Common Stock | Additional Paid-in CapitalPublic offering | Additional Paid-in CapitalAt-the-market sales | Additional Paid-in Capital | Accumulated Other Comprehensive Income | Accumulated Deficit | Public offering | At-the-market sales | Total |
Balance at Dec. 31, 2019 | $ 7 | $ 306,108 | $ (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 | 621 | 621 | |||||||||
Issuance of common stock | $ 2 | $ 48,433 | $ 48,435 | ||||||||
Issuance of common stock (in shares) | 17,250,000 | ||||||||||
Issuance of common stock upon exercise of options | 119 | 119 | |||||||||
Issuance of common stock upon exercise of options (in shares) | 152,907 | ||||||||||
Warrants issued in connection with long-term debt | 3,570 | 3,570 | |||||||||
Net loss | (7,883) | (7,883) | |||||||||
Balance at Mar. 31, 2020 | $ 9 | 358,851 | (268,253) | 90,607 | |||||||
Balance (in shares) at Mar. 31, 2020 | 87,213,212 | ||||||||||
Balance at Dec. 31, 2019 | $ 7 | 306,108 | (260,370) | 45,745 | |||||||
Balance (in shares) at Dec. 31, 2019 | 69,810,305 | ||||||||||
Increase (decrease) in stockholders' equity | |||||||||||
Unrealized net gain on marketable securities | 10 | ||||||||||
Net loss | (18,709) | ||||||||||
Balance at Jun. 30, 2020 | $ 9 | 359,856 | $ 10 | (279,079) | 80,796 | ||||||
Balance (in shares) at Jun. 30, 2020 | 87,297,605 | ||||||||||
Balance at Mar. 31, 2020 | $ 9 | 358,851 | (268,253) | 90,607 | |||||||
Balance (in shares) at Mar. 31, 2020 | 87,213,212 | ||||||||||
Increase (decrease) in stockholders' equity | |||||||||||
Share-based compensation - stock options and RSUs | 839 | 839 | |||||||||
Issuance of common stock upon exercise of options | 166 | 166 | |||||||||
Issuance of common stock upon exercise of options (in shares) | 84,393 | ||||||||||
Unrealized net gain on marketable securities | 10 | 10 | |||||||||
Net loss | (10,826) | (10,826) | |||||||||
Balance at Jun. 30, 2020 | $ 9 | 359,856 | 10 | (279,079) | 80,796 | ||||||
Balance (in shares) at Jun. 30, 2020 | 87,297,605 | ||||||||||
Balance at Dec. 31, 2020 | $ 9 | 361,539 | 3 | (312,223) | 49,328 | ||||||
Balance (in shares) at Dec. 31, 2020 | 87,563,753 | ||||||||||
Increase (decrease) in stockholders' equity | |||||||||||
Share-based compensation - stock options and RSUs | 742 | 742 | |||||||||
Issuance of common stock | $ 960 | $ 960 | |||||||||
Issuance of common stock (in shares) | 520,937 | ||||||||||
Issuance of common stock upon exercise of options | 75 | 75 | |||||||||
Issuance of common stock upon exercise of options (in shares) | 126,400 | ||||||||||
Vesting of RSUs (in shares) | 52,651 | ||||||||||
Warrants issued in connection with long-term debt | 1,080 | 1,080 | |||||||||
Unrealized net gain on marketable securities | (3) | (3) | |||||||||
Net loss | (17,128) | (17,128) | |||||||||
Balance at Mar. 31, 2021 | $ 9 | 364,396 | (329,351) | 35,054 | |||||||
Balance (in shares) at Mar. 31, 2021 | 88,263,741 | ||||||||||
Balance at Dec. 31, 2020 | $ 9 | 361,539 | $ 3 | (312,223) | 49,328 | ||||||
Balance (in shares) at Dec. 31, 2020 | 87,563,753 | ||||||||||
Increase (decrease) in stockholders' equity | |||||||||||
Issuance of common stock (in shares) | 5,113,971 | ||||||||||
Unrealized net gain on marketable securities | (3) | ||||||||||
Net loss | (34,765) | ||||||||||
Balance at Jun. 30, 2021 | $ 9 | 371,588 | (346,988) | 24,609 | |||||||
Balance (in shares) at Jun. 30, 2021 | 92,928,205 | ||||||||||
Balance at Mar. 31, 2021 | $ 9 | 364,396 | (329,351) | 35,054 | |||||||
Balance (in shares) at Mar. 31, 2021 | 88,263,741 | ||||||||||
Increase (decrease) in stockholders' equity | |||||||||||
Share-based compensation - stock options and RSUs | 843 | 843 | |||||||||
Issuance of common stock | $ 6,349 | $ 6,349 | |||||||||
Issuance of common stock (in shares) | 4,593,034 | ||||||||||
Vesting of RSUs (in shares) | 71,430 | ||||||||||
Net loss | (17,637) | (17,637) | |||||||||
Balance at Jun. 30, 2021 | $ 9 | $ 371,588 | $ (346,988) | $ 24,609 | |||||||
Balance (in shares) at Jun. 30, 2021 | 92,928,205 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (34,765,000) | $ (18,709,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 1,029,000 | 8,000 |
Amortization | 67,000 | 82,000 |
Noncash stock-based compensation | 1,585,000 | 1,460,000 |
Noncash interest | 864,000 | 447,000 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (302,000) | |
Inventory | (3,462,000) | |
Prepaid expenses and other assets | 552,000 | (686,000) |
Accounts payable and accrued expenses | 4,494,000 | 2,839,000 |
Lease liability | (66,000) | (90,000) |
Net cash used in operating activities | (30,004,000) | (14,649,000) |
Cash flows from investing activities: | ||
Purchases of marketable securities | (47,822,000) | |
Sales and maturities of marketable securities | 34,729,000 | |
Acquisition of property and equipment | (149,000) | (222,000) |
Net cash provided by (used in) investing activities | 34,580,000 | (48,044,000) |
Cash flows from financing activities: | ||
Proceeds from issuance of long-term debt | 20,000,000 | |
Debt financing costs paid | (1,059,000) | |
Proceeds from exercise of stock options | 75,000 | 285,000 |
Net cash provided by financing activities | 7,079,000 | 67,660,000 |
Net increase in cash and cash equivalents | 11,655,000 | 4,967,000 |
Cash and cash equivalents, beginning of period | 14,463,000 | 34,479,000 |
Cash and cash equivalents, end of period | 26,118,000 | 39,446,000 |
Supplemental disclosure of noncash financing activities | ||
Warrants issued in connection with long-term debt | 1,080,000 | 3,570,000 |
Supplemental cash flow information | ||
Interest paid | 1,182,000 | 896,000 |
Public offering | ||
Cash flows from financing activities: | ||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 48,434,000 | |
At-the-market sales | ||
Cash flows from financing activities: | ||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 7,004,000 |
Organization and Description of
Organization and Description of Business | 6 Months Ended |
Jun. 30, 2021 | |
Organization and Description of Business | |
Organization and Description of Business | Nature of Operations Agile Therapeutics, Inc. (“Agile” or the “Company”) was incorporated in Delaware on December 22, 1997. Agile is a women’s healthcare company dedicated to fulfilling the unmet health needs of today’s women. The Company’s activities since inception have consisted principally of raising capital, performing research and development, including development of the Company’s lead product, Twirla, and more recently commercializing 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 June 30, 2021, the Company had an accumulated deficit of approximately $347 million. The Company expects to continue to incur significant operating expenses for the foreseeable future in connection with its ongoing activities, as the Company: ● maintains a sales and marketing infrastructure to support the continued commercialization of Twirla in the United States; ● continues to evaluate additional line extensions for Twirla and initiates development of potential product candidates in addition to Twirla; ● maintains, leverages and expands the Company’s intellectual property portfolio; and ● adds operational, financial and management information systems and personnel, including personnel to support the Company’s product development and future commercialization efforts. The Company has financed its operations to date primarily through the issuance and sale of its common stock in both public and private offerings (see Note 9), private placements of its convertible preferred stock, venture loans, and non-dilutive grant funding. Going Concern As of June 30, 2021, the Company had cash, cash equivalents and marketable securities of $31.1 million. The Company closely monitors its cash, cash equivalents and marketable securities and will need to raise additional funds to meet its projected operating requirements, including the continued commercialization of Twirla, and exploring the advancement of its existing pipeline and its possible expansion through business development activities. The Company has generated losses since inception, used substantial cash in operations and anticipates it will continue to incur net losses for the foreseeable future. The Company’s future success depends on its ability to obtain additional capital and/or implement various strategic alternatives, and there can be no assurance that any financing can be realized by the Company, or if realized, what the terms of any such financing may be, or that any amount that the Company is able to raise will be adequate. Based upon the foregoing, management has concluded that there is substantial doubt about the Company’s ability to continue as a going concern through the 12 months following the date on which this Quarterly Report on Form 10-Q is filed. The Company continues to analyze various alternatives, including refinancing alternatives, asset sales and mergers and acquisitions. The Company’s future success depends on its ability to raise additional capital as discussed above. The Company cannot be certain that these initiatives or raising additional capital, whether through selling additional debt or equity securities or obtaining a line of credit or other loan, will be available to it or, if available, will be on terms acceptable to the Company. If the Company issues additional securities to raise funds, these securities may have rights, preferences, or privileges senior to those of its common stock, and the Company’s current stockholders will experience dilution. If the Company is unable to obtain funds when needed or on acceptable terms, the Company then may be unable to continue the commercialization of Twirla, and may also be required to cut operating costs, and forego future development and other opportunities. The unaudited financial statements as of June 30, 2021 have been prepared under the assumption that the Company will continue as a going concern for the next 12 months. The Company’s ability to continue as a going concern is dependent upon its uncertain ability to obtain additional capital, reduce expenditures and/or execute on its business plan and successfully commercialize Twirla. The unaudited financial statements as of June 30, 2021 do not include any adjustments that might result from the outcome of this uncertainty. If the Company is unable to continue as a going concern, it may have to liquidate its assets and may receive less than the value at which those assets are carried on the financial statements. Basis of Presentation The accompanying unaudited interim financial statements have been prepared by the Company in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim information and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for reporting on Form 10-Q. Accordingly, certain information and footnote disclosure normally included in financial statements prepared in accordance with U.S. GAAP has been condensed or omitted pursuant to such rules and regulations. These interim financial statements should be read in conjunction with the audited financial statements and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 as filed with the SEC on March 1, 2021. In the opinion of management, the unaudited interim financial statements reflect all adjustments, which are normal recurring adjustments, necessary for the fair presentation of the financial information for the interim periods presented. The results of operations for the three and six months ended June 30, 2021 are not necessarily indicative of the operating results for the full fiscal year or any future period. Certain reclassifications have been made to prior periods to conform with current reporting. On the statement of operations, the Company has separated the presentation of selling and marketing expenses from total general and administrative expenses. To conform prior year amounts to the current period presentation, $3.2 million and $4.9 million was reclassified from general and administrative expenses to selling and marketing expenses for the three and six months ended June 30, 2020, respectively. The accompanying financial statements have been prepared on a basis which assumes that the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company has incurred recurring losses and negative cash flows from operations. Based on the Company’s current business plan and ability to commercialize Twirla, the Company believes that its cash, cash equivalents and marketable securities as of June 30, 2021 will be sufficient to meet its projected operating requirements through the end of 2021 . If the COVID-19 pandemic or other factors impact the Company’s current business plan or its ability to generate revenue from the launch of Twirla, the Company believes it has the ability to revise its commercial plans, including curtailing sales and marketing spending, to allow it to continue to fund its operations |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2021 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies The Company’s complete listing of significant accounting policies is described in Note 2 to the Company’s audited financial statements as of December 31, 2020 included in its Annual Report on Form 10-K filed with the SEC. 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. It is unknown how long these conditions will last and what the complete effect will be on the Company. While to date we have been able to continue to execute our overall business plan, some of our business activities have been slowed and taken longer to complete and we continue to adjust to the challenges of operating in a largely remote setting with our employees. We have only recently launched our commercial activities for Twirla and begun engaging with healthcare providers to promote Twirla. We expect that, as we broaden our sales detailing activities, in some instances our sales force may encounter challenges engaging with healthcare providers during this on-going pandemic. Although many areas of the United States have begun to re-open access to offices and other commercial facilities, there continue to be areas where restrictions remain in place, which may have the potential to affect our ability to conduct our business. Further, new variants, some of which could be resistant to existing vaccines, may lead to new shutdowns or business disruptions in the future. The Company will continue to closely monitor events as they develop and evaluate alternative, mitigating measures it can implement if needed. Cash and Cash Equivalents The Company considers all highly-liquid investments with an original maturity of three months or less when purchased to be cash equivalents. All cash and cash equivalents are held in United States financial institutions. Cash and cash equivalents include money market funds that invest primarily in commercial paper and U.S. government and U.S. government agency obligations. The Company maintains balances with financial institutions in excess of the Federal Deposit Insurance Corporation limit. Marketable Securities The Company invests a portion of its excess cash balances in marketable securities, including U.S. government agency securities, and highly rated corporate bonds. The Company classifies all of its marketable securities as current assets on the balance sheet because they are available-for-sale and available to fund current operations. Marketable securities are stated at fair value with unrealized gains and losses included as a component of accumulated other comprehensive income (loss), which is a separate component of stockholders' equity, until such gains and losses are realized. If a decline in the fair value is considered other-than-temporary, based on available evidence, the unrealized loss is reclassified from accumulated other comprehensive income (loss) to the statements of operations. Realized gains and losses are determined on the specific identification method and are included in other income. Trade Accounts Receivable and Allowances Trade accounts receivable are amounts owed to the Company by its customers for product that has been delivered. The trade accounts receivable are recorded at the invoice amount, less prompt pay and other discounts, chargebacks, and an allowance for credit losses, if any. The allowance for credit losses represents the Company’s estimate of losses over the life of the receivables. The Company evaluates forward looking economic factors and uses professional judgment to determine the allowance for credit losses, as Twirla was commercially launched in December 2020 and historical data is not yet available. The credit loss reserves are reviewed and adjusted periodically. Credit loss reserves were not material as of June 30, 2021. Trade accounts receivable are aged based on the contractual payment terms. When the collectability of an invoice is no longer probable, the Company will create a reserve for that specific receivable. If a receivable is determined to be uncollectible, it is charged against the general credit loss reserve or the reserve for the specific receivable, if one exists. Fair Value of Financial Instruments In accordance with Accounting Standards Codification (“ASC”) 825, Financial Instruments Other financial instruments, including accounts receivable, accounts payable and accrued liabilities, are carried at cost, which approximates fair value given their short-term nature. Inventory Inventory is valued utilizing the weighted average costing method. The Company records an inventory reserve for losses associated with dated, expired, excess or obsolete items. This reserve is based on management’s current knowledge with respect to inventory levels, planned production and sales volume assumptions. 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, completed the validation of the commercial manufacturing process for Twirla in the fourth quarter of 2020. The costs associated with validation batches were expensed as research and development expenses during the period the costs were incurred. The Company used this validation product for commercial supplies and samples of Twirla into May 2021. Since the Company did not capitalize any validation product, all sales of this validation product had no associated product cost. During the three and six months ended June 30, 2021, units sold with no associated product cost were approximately 2,000 and 3,000 , respectively. Had such inventory been valued at acquisition cost, it would have resulted in an immaterial increase to cost of goods sold and a corresponding decrease to gross profit. Property and Equipment Property and equipment, consisting of 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 the carrying values of any long-lived assets are impaired as of June 30, 2021. Research and Development Expenses Research and development expenses consist 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 product 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 $3.0 million and $0 for the three months ended June 30, 2021 and 2020, respectively, and totaled $6.1 million and $0 for the six months ended June 30, 2021 and 2020, respectively. Deferred Financing Costs Costs directly attributable to the Company’s senior secured term loan (see Note 8) are deferred and reported as a reduction of the related term loan. These costs represent a 1% facility fee paid directly to the lender, legal fees and other costs related to the term loan and are being amortized over the term of the loan. Amortization of deferred financing costs charged to interest expense was $69,000 for each of the three months ended June 30, 2021 and 2020, and was Concentrations of Credit Risk Financial instruments which potentially subject the Company to credit risk consist principally of cash, cash equivalents, marketable securities and accounts receivable. 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 Major customers of the Company are defined as those constituting greater than 10% of its total revenue. In the three months ended June 30, 2021, the Company had sales to customers that individually accounted for more than 10% of its total revenue. These customers had sales of of total revenues in the quarter. Accounts receivable related to these Revenue Recognition The Company recognizes revenue from the sale of its product, Twirla, in accordance with ASC 606, Revenue from Contracts with Customers In accordance with ASC 606, the Company recognizes revenue at the point in time when its performance obligation is satisfied by transferring control of the promised goods or services to a customer. In accordance with the Company’s contracts with customers, control of the product is transferred upon the conveyance of title, which occurs when the product is sold to and received by a customer. The Company’s customers are located in the United States and consist primarily of wholesale distributors. Trade accounts receivable due to the Company from contracts with its customers are stated separately in the balance sheet, net of various allowances as described in the Trade Accounts Receivable and Allowance policy. The amount of revenue recognized by the Company is equal to the amount of consideration that is expected to be received from the sale of product to its customers. Revenue is only recognized when it is probable that a significant reversal will not occur in future periods. To determine whether a significant reversal will occur in future periods, the Company assesses both the likelihood and magnitude of any such potential reversal of revenue. Twirla is sold to customers at the Wholesale Acquisition Cost (WAC). However, the Company records product revenue, net of reserves for applicable variable consideration. These types of variable consideration items reduce revenue and include the following: • Distribution services fees; • Prompt pay and other discounts; • Product returns; • Chargebacks; • Rebates; and • Co-payment assistance. An estimate for each variable consideration item is made and is recorded in conjunction with the revenue being recognized. Generally, if the estimated amount is payable to a customer, it is recorded as a reduction to accounts receivable. If the estimated amount is payable to an entity other than a customer, it is recorded as a current liability. An estimated amount of variable consideration may differ from the actual amount. At each balance sheet date, these provisions are analyzed, and adjustments are made if necessary. Any adjustments made to these provisions would affect net product revenue and earnings in the current period. In accordance with ASC 606, the Company must make 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 relies on industry standard data and trend analysis as historical sales data for Twirla are not yet available based on the December 2020 launch date. Once historical data becomes available, the Company will incorporate Twirla specific data into its estimates of variable consideration. The Company uses the following specific considerations to estimate variable consideration. Distribution services fees – The Company pays distribution service fees to its wholesale distributors. These fees are a contractually fixed percentage of WAC and are calculated at the time of sale based on the purchase amount. The Company records these fees as contra trade accounts receivable on the balance sheet. Prompt pay and other discount The Company may also give other discounts to its customers to incentivize purchases and promote customer loyalty. The terms of such discounts may vary by customer. These discounts reduce gross product revenue at the time the revenue is recorded. Product returns made based on industry-standard data and trend analysis. As time passes and historical data becomes available, the Company will use historical sales and return data to estimate future product returns. Chargebacks – Certain government entities and indirect customers (for example group purchasing organizations and 340B covered entities) will be able to purchase the product at a price discounted below WAC. The difference between the price paid by the government or other indirect purchaser and the price paid by the wholesale distributor 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 Co-payment assistance Provisions for the revenue reserves described above totaled $345,000 and $348,000 for the three- and six-months ending June 30, 2021, respectively. As of June 30, 2021, reserves on the balance sheet associated with variable consideration were $0.3 million. Warrants The Company accounts for its warrants to purchase common stock in accordance with ASC 480, Distinguishing Liabilities from Equity . In connection with entering into a senior secured term loan facility in February 2020, the Company issued warrants to purchase 1,400,000 shares of its common stock. In connection with an amendment to that facility in February 2021, the Company issued a warrant to purchase 450,000 shares of the Company’s common stock. Income Taxes The Company accounts for deferred taxes using the asset and liability method as specified by ASC 740, Income Taxes The Company has adopted the authoritative guidance on accounting for and disclosure of uncertainty in tax positions which prescribes a comprehensive model for the financial statement recognition, measurement, presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns. The Company has no uncertain tax positions as of June 30, 2021 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 no less than 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. 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 three months ended June 30, 2021 and 2020, respectively, because to do so would be anti-dilutive (in common equivalent shares): June 30, 2021 2020 Common stock warrants 1,850,000 1,400,000 Unvested restricted stock units 253,697 159,795 Common stock options 10,352,326 8,503,254 Total 12,456,023 10,063,049 Recent Accounting Pronouncements 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 Company adopted ASU 2019-12 effective January 1, 2021. The adoption of this standard did not have a material impact on its financial statements. In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation— Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815- 40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“ASU 2021-04”). The guidance is effective for the Company on January 1, 2022. The Company is currently evaluating the impact of adopting this standard and does not expect the guidance to have a material impact on its financial statements. Management does not believe that any other recently issued, but not yet effective accounting pronouncements, if adopted, would have a material impact on the accompanying financial statements. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Measurements | |
Fair Value Measurements | 3. Fair Value Measurements ASC 820, Fair Value Measurements and Disclosures Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. Assets and liabilities that are measured at fair value are reported using a three-level fair value hierarchy that prioritizes the inputs used to measure fair value. This hierarchy maximizes the use of observable inputs and minimizes the use of unobservable inputs. The three levels of inputs used to measure fair value are as follows: ● Level 1 — Quoted prices in active markets for identical assets or liabilities. The Company’s Level 1 assets consist of cash and cash equivalents. The Company has no Level 1 liabilities. ● Level 2 — Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted market prices for similar assets or liabilities in active markets or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets and liabilities. Level 2 assets consist of marketable securities. The Company has no Level 2 liabilities. ● Level 3 — Unobservable inputs that are supported by little or no market data and which require internal development of assumptions about how market participants price the fair value of the assets or liabilities. The Company has no Level 3 assets or liabilities. The following table sets forth the Company’s financial instruments measured at fair value by level within the fair value hierarchy as of June 30, 2021 and December 31, 2020. Level 1 Level 2 Level 3 June 30, 2021 Assets: Cash and cash equivalents $ 26,118 $ — $ — Marketable securities — 4,999 — Total assets at fair value $ 26,118 $ 4,999 $ — Level 1 Level 2 Level 3 December 31, 2020 Assets: Cash and cash equivalents $ 14,463 $ — $ — Marketable securities — 40,008 — Total assets at fair value $ 14,463 $ 40,008 $ — There were no transfers between Level 1, 2 or 3 during 2021 or 2020. |
Marketable Securities
Marketable Securities | 6 Months Ended |
Jun. 30, 2021 | |
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 June 30, 2021 U.S. government obligations (maturing in one year or less) $ 3,000 $ — $ — $ 3,000 Corporate debt securities (maturing in one year or less) 1,999 — — 1,999 Total marketable securities $ 4,999 $ — $ — $ 4,999 The Company holds investment-grade marketable securities. There were no continuous unrealized loss positions in excess of twelve months as of June 30, 2021. There was no accrued interest income at June 30, 2021. |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 6 Months Ended |
Jun. 30, 2021 | |
Prepaid Expenses and Other Current Assets | |
Prepaid Expenses and Other Current Assets | 5 Prepaid expenses and other current assets consist of the following: June 30, December 31, 2021 2020 Prepaid insurance $ 259 $ 680 Other 943 769 Total prepaid expenses and other current assets $ 1,202 $ 1,449 |
Accrued Liabilities
Accrued Liabilities | 6 Months Ended |
Jun. 30, 2021 | |
Accrued Liabilities | |
Accrued Liabilities | 6 Accrued liabilities consist of the following: June 30, December 31, 2021 2020 Accrued compensation $ 1,397 $ 1,697 Accrued professional fees and other 3,756 1,651 Total accrued liabilities $ 5,153 $ 3,348 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2021 | |
Leases | |
Leases | 7 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. The Company has no finance leases and one operating lease for office space in Princeton, NJ. Operating lease expense was $38,000 and $75,000 for the three and six months ended June 30, 2021, respectively. Operating cash flows used for operating leases during the three and six months ended June 30, 2021 were $34,000 and $66,000 , respectively. As of June 30, 2021, the weighted-average remaining lease term was 0.50 years and the weighted average discount rate was 15.2%. Future minimum lease payments under non-cancellable leases as of June 30, 2021 were as follows: 2021 $ 75 Total $ 75 Less: Interest (3) Present value of lease liability $ 72 |
Credit Agreement and Guaranty
Credit Agreement and Guaranty | 6 Months Ended |
Jun. 30, 2021 | |
Credit Agreement and Guaranty | |
Credit Agreement and Guaranty | 8 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 Amended 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 rate of interest in effect as of the Closing Date and at June 30, 2021 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 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 Amended 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. At June 30, 2021, the Company was in compliance with the cash balance covenant, but not in compliance with the revenue covenant. The Company obtained a written waiver from the lender with respect to the Company’s failure to meet the revenue covenant for the three months ended June 30, 2021. In connection with the Perceptive Credit Agreement, the Company issued to Perceptive two warrants to purchase an aggregate of 1,400,000 shares of the Company’s common stock (together, the “2020 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 2020 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 “2021 Perceptive Warrant” and, together with the 2020 Perceptive Warrants, the “Perceptive Warrants”) at an exercise price of $2.87 per share. The 2021 Perceptive Warrant expires on February 26, 2028. 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 Company allocated the proceeds of $20.0 million in accordance with ASC 470 based on the relative fair values of the debt and the Perceptive Warrants. The relative fair value of the Perceptive 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 Perceptive Warrants issued include (i) volatility (70.0%), (ii) risk free interest rate of 1.47% (estimated using treasury bonds with a 7-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 2021 Perceptive Warrants of approximately $1.1 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 2021 Perceptive Warrants issued include (i) volatility (103.5%), (ii) risk free interest rate of 1.15% (estimated using treasury bonds with a 7-year life), (iii) strike price of $2.87 for the common stock warrant, (iv) fair value of common stock ($2.87) 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 (in thousands). June 30, 2021 Notes payable $ 20,000 Debt issuance costs (689) Warrant discount (3,276) Long-term debt $ 16,035 The fair value of the warrants and the debt issue costs are being amortized utilizing the effective interest method over the term of the loan. The Company recorded interest expense for the amortization of the fair value of the warrants and debt issue costs of $398,000 and $303,000 for the three months ended June 30, 2021 and 2020, respectively, and $734,000 and $404,000 for the six months ended June 30, 2021 and 2020, respectively. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2021 | |
Stockholders' Equity | |
Stockholders' Equity | 9 Shelf Registration Statement On October 2, 2020, the Company filed a universal shelf registration statement with the SEC for the issuance of common stock, preferred stock, warrants, rights, debt securities and units up to an aggregate amount of $200.0 million (the “2020 Shelf Registration Statement”). On October 14, 2020, the 2020 Shelf Registration Statement was declared effective by the SEC. In the future, the Company may periodically offer one or more of these securities in amounts, prices and terms to be announced when and if the securities are offered. At the time any of the securities covered by the 2020 Shelf Registration Statement are offered for sale, a prospectus supplement will be prepared and filed with the SEC containing specific information about the terms of any such offering. Public Offerings In February 2020, the Company completed a public offering of 17,250,000 shares of its 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. ATM Sales Agreement In March 2021, the Company entered into a common stock sales agreement (the “Sales Agreement”) under which the Company may sell up to an aggregate of $50.0 million in gross proceeds through the sale of shares of common stock from time to time in “at-the-market” equity offerings (as defined in Rule 415 promulgated under the Securities Act of 1933, as amended). The Company agreed to pay a commission of up to 3% of the gross proceeds of any common stock sold under the Sales Agreement. During the six months ended June 30, 2021, the Company issued and sold 5,113,971 shares of common stock under the Sales Agreement resulting in net proceeds to the Company of approximately $7.4 million, of which $7.0 million was received by June 30, 2021. Stock-Based Compensation Expense Stock-based compensation expense was allocated as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2021 2020 2021 2020 Cost of goods sold $ 75 $ — $ 135 $ — Research and development 121 139 228 337 Selling and marketing 43 26 78 43 General and administrative 604 674 1,144 1,080 Total $ 843 $ 839 $ 1,585 $ 1,460 |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Income | 6 Months Ended |
Jun. 30, 2021 | |
Accumulated Other Comprehensive Income Loss Net Of Tax [Abstract] | |
Accumulated Other Comprehensive Income | 10. Accumulated Other Comprehensive Income The change in accumulated other comprehensive income, which is reported as a component of stockholders’ equity, for the six months ended June 30, 2021 is summarized below (in thousands): Unrealized Gain on Marketable Securities Balance December 31, 2020 $ 3 Other comprehensive income (3) Balance June 30, 2021 $ — No amounts were classified out of accumulated other comprehensive income during the six months ended June 30, 2021. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2021 | |
Income Taxes | |
Income Taxes | 11. Income Taxes On March 27, 2020, the U.S. government enacted the Coronavirus Aid, Relief, and Economic Security Act (the “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 income tax provision. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies | |
Commitments and Contingencies | 12. Commitments and Contingencies The Company has several firm purchase commitments, primarily related to the manufacture and supply of Twirla and the supply of a field force of sales representatives to provide certain detailing services, sales operation services, compliance services, and training services. Future firm purchase commitments under these agreements, the last of which ends in 2030, total $10.9 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 June 30, 2021, the Company has not recorded a provision for any contingent losses. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Summary of Significant Accounting Policies | |
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. It is unknown how long these conditions will last and what the complete effect will be on the Company. While to date we have been able to continue to execute our overall business plan, some of our business activities have been slowed and taken longer to complete and we continue to adjust to the challenges of operating in a largely remote setting with our employees. We have only recently launched our commercial activities for Twirla and begun engaging with healthcare providers to promote Twirla. We expect that, as we broaden our sales detailing activities, in some instances our sales force may encounter challenges engaging with healthcare providers during this on-going pandemic. Although many areas of the United States have begun to re-open access to offices and other commercial facilities, there continue to be areas where restrictions remain in place, which may have the potential to affect our ability to conduct our business. Further, new variants, some of which could be resistant to existing vaccines, may lead to new shutdowns or business disruptions in the future. The Company will continue to closely monitor events as they develop and evaluate alternative, mitigating measures it can implement if needed. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly-liquid investments with an original maturity of three months or less when purchased to be cash equivalents. All cash and cash equivalents are held in United States financial institutions. Cash and cash equivalents include money market funds that invest primarily in commercial paper and U.S. government and U.S. government agency obligations. The Company maintains balances with financial institutions in excess of the Federal Deposit Insurance Corporation limit. |
Marketable Securities | Marketable Securities The Company invests a portion of its excess cash balances in marketable securities, including U.S. government agency securities, and highly rated corporate bonds. The Company classifies all of its marketable securities as current assets on the balance sheet because they are available-for-sale and available to fund current operations. Marketable securities are stated at fair value with unrealized gains and losses included as a component of accumulated other comprehensive income (loss), which is a separate component of stockholders' equity, until such gains and losses are realized. If a decline in the fair value is considered other-than-temporary, based on available evidence, the unrealized loss is reclassified from accumulated other comprehensive income (loss) to the statements of operations. Realized gains and losses are determined on the specific identification method and are included in other income. |
Trade Accounts Receivable and Allowances | Trade Accounts Receivable and Allowances Trade accounts receivable are amounts owed to the Company by its customers for product that has been delivered. The trade accounts receivable are recorded at the invoice amount, less prompt pay and other discounts, chargebacks, and an allowance for credit losses, if any. The allowance for credit losses represents the Company’s estimate of losses over the life of the receivables. The Company evaluates forward looking economic factors and uses professional judgment to determine the allowance for credit losses, as Twirla was commercially launched in December 2020 and historical data is not yet available. The credit loss reserves are reviewed and adjusted periodically. Credit loss reserves were not material as of June 30, 2021. Trade accounts receivable are aged based on the contractual payment terms. When the collectability of an invoice is no longer probable, the Company will create a reserve for that specific receivable. If a receivable is determined to be uncollectible, it is charged against the general credit loss reserve or the reserve for the specific receivable, if one exists. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments In accordance with Accounting Standards Codification (“ASC”) 825, Financial Instruments Other financial instruments, including accounts receivable, accounts payable and accrued liabilities, are carried at cost, which approximates fair value given their short-term nature. |
Inventory | Inventory Inventory is valued utilizing the weighted average costing method. The Company records an inventory reserve for losses associated with dated, expired, excess or obsolete items. This reserve is based on management’s current knowledge with respect to inventory levels, planned production and sales volume assumptions. 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, completed the validation of the commercial manufacturing process for Twirla in the fourth quarter of 2020. The costs associated with validation batches were expensed as research and development expenses during the period the costs were incurred. The Company used this validation product for commercial supplies and samples of Twirla into May 2021. Since the Company did not capitalize any validation product, all sales of this validation product had no associated product cost. During the three and six months ended June 30, 2021, units sold with no associated product cost were approximately 2,000 and 3,000 , respectively. Had such inventory been valued at acquisition cost, it would have resulted in an immaterial increase to cost of goods sold and a corresponding decrease to gross profit. |
Property and Equipment | Property and Equipment Property and equipment, consisting of 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 the carrying values of any long-lived assets are impaired as of June 30, 2021. |
Research and Development Expense | Research and Development Expenses Research and development expenses consist 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 product 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 $3.0 million and $0 for the three months ended June 30, 2021 and 2020, respectively, and totaled $6.1 million and $0 for the six months ended June 30, 2021 and 2020, respectively. |
Deferred Financing Costs | Deferred Financing Costs Costs directly attributable to the Company’s senior secured term loan (see Note 8) are deferred and reported as a reduction of the related term loan. These costs represent a 1% facility fee paid directly to the lender, legal fees and other costs related to the term loan and are being amortized over the term of the loan. Amortization of deferred financing costs charged to interest expense was $69,000 for each of the three months ended June 30, 2021 and 2020, and was |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments which potentially subject the Company to credit risk consist principally of cash, cash equivalents, marketable securities and accounts receivable. 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 Major customers of the Company are defined as those constituting greater than 10% of its total revenue. In the three months ended June 30, 2021, the Company had sales to customers that individually accounted for more than 10% of its total revenue. These customers had sales of of total revenues in the quarter. Accounts receivable related to these |
Revenue Recognition | Revenue Recognition The Company recognizes revenue from the sale of its product, Twirla, in accordance with ASC 606, Revenue from Contracts with Customers In accordance with ASC 606, the Company recognizes revenue at the point in time when its performance obligation is satisfied by transferring control of the promised goods or services to a customer. In accordance with the Company’s contracts with customers, control of the product is transferred upon the conveyance of title, which occurs when the product is sold to and received by a customer. The Company’s customers are located in the United States and consist primarily of wholesale distributors. Trade accounts receivable due to the Company from contracts with its customers are stated separately in the balance sheet, net of various allowances as described in the Trade Accounts Receivable and Allowance policy. The amount of revenue recognized by the Company is equal to the amount of consideration that is expected to be received from the sale of product to its customers. Revenue is only recognized when it is probable that a significant reversal will not occur in future periods. To determine whether a significant reversal will occur in future periods, the Company assesses both the likelihood and magnitude of any such potential reversal of revenue. Twirla is sold to customers at the Wholesale Acquisition Cost (WAC). However, the Company records product revenue, net of reserves for applicable variable consideration. These types of variable consideration items reduce revenue and include the following: • Distribution services fees; • Prompt pay and other discounts; • Product returns; • Chargebacks; • Rebates; and • Co-payment assistance. An estimate for each variable consideration item is made and is recorded in conjunction with the revenue being recognized. Generally, if the estimated amount is payable to a customer, it is recorded as a reduction to accounts receivable. If the estimated amount is payable to an entity other than a customer, it is recorded as a current liability. An estimated amount of variable consideration may differ from the actual amount. At each balance sheet date, these provisions are analyzed, and adjustments are made if necessary. Any adjustments made to these provisions would affect net product revenue and earnings in the current period. In accordance with ASC 606, the Company must make 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 relies on industry standard data and trend analysis as historical sales data for Twirla are not yet available based on the December 2020 launch date. Once historical data becomes available, the Company will incorporate Twirla specific data into its estimates of variable consideration. The Company uses the following specific considerations to estimate variable consideration. Distribution services fees – The Company pays distribution service fees to its wholesale distributors. These fees are a contractually fixed percentage of WAC and are calculated at the time of sale based on the purchase amount. The Company records these fees as contra trade accounts receivable on the balance sheet. Prompt pay and other discount The Company may also give other discounts to its customers to incentivize purchases and promote customer loyalty. The terms of such discounts may vary by customer. These discounts reduce gross product revenue at the time the revenue is recorded. Product returns made based on industry-standard data and trend analysis. As time passes and historical data becomes available, the Company will use historical sales and return data to estimate future product returns. Chargebacks – Certain government entities and indirect customers (for example group purchasing organizations and 340B covered entities) will be able to purchase the product at a price discounted below WAC. The difference between the price paid by the government or other indirect purchaser and the price paid by the wholesale distributor 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 Co-payment assistance Provisions for the revenue reserves described above totaled $345,000 and $348,000 for the three- and six-months ending June 30, 2021, respectively. As of June 30, 2021, reserves on the balance sheet associated with variable consideration were $0.3 million. |
Warrants | Warrants The Company accounts for its warrants to purchase common stock in accordance with ASC 480, Distinguishing Liabilities from Equity . In connection with entering into a senior secured term loan facility in February 2020, the Company issued warrants to purchase 1,400,000 shares of its common stock. In connection with an amendment to that facility in February 2021, the Company issued a warrant to purchase 450,000 shares of the Company’s common stock. |
Income Taxes | Income Taxes The Company accounts for deferred taxes using the asset and liability method as specified by ASC 740, Income Taxes The Company has adopted the authoritative guidance on accounting for and disclosure of uncertainty in tax positions which prescribes a comprehensive model for the financial statement recognition, measurement, presentation and disclosure of uncertain tax positions taken or expected to be taken in income tax returns. The Company has no uncertain tax positions as of June 30, 2021 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 no less than 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. |
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 three months ended June 30, 2021 and 2020, respectively, because to do so would be anti-dilutive (in common equivalent shares): June 30, 2021 2020 Common stock warrants 1,850,000 1,400,000 Unvested restricted stock units 253,697 159,795 Common stock options 10,352,326 8,503,254 Total 12,456,023 10,063,049 |
Recent Accounting Pronouncements | Recent Accounting Pronouncements 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 Company adopted ASU 2019-12 effective January 1, 2021. The adoption of this standard did not have a material impact on its financial statements. In May 2021, the FASB issued ASU 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation— Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815- 40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“ASU 2021-04”). The guidance is effective for the Company on January 1, 2022. The Company is currently evaluating the impact of adopting this standard and does not expect the guidance to have a material impact on its financial statements. Management does not believe that any other recently issued, but not yet effective accounting pronouncements, if adopted, would have a material impact on the accompanying financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Summary of Significant Accounting Policies | |
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 three months ended June 30, 2021 and 2020, respectively, because to do so would be anti-dilutive (in common equivalent shares): June 30, 2021 2020 Common stock warrants 1,850,000 1,400,000 Unvested restricted stock units 253,697 159,795 Common stock options 10,352,326 8,503,254 Total 12,456,023 10,063,049 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Measurements | |
Schedule of financial instruments measured at fair value by level within the fair value hierarchy | Level 1 Level 2 Level 3 June 30, 2021 Assets: Cash and cash equivalents $ 26,118 $ — $ — Marketable securities — 4,999 — Total assets at fair value $ 26,118 $ 4,999 $ — Level 1 Level 2 Level 3 December 31, 2020 Assets: Cash and cash equivalents $ 14,463 $ — $ — Marketable securities — 40,008 — Total assets at fair value $ 14,463 $ 40,008 $ — |
Marketable Securities (Tables)
Marketable Securities (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Marketable Securities | |
Summary of marketable securities, classified as available-for-sale | Gross Unrealized Amortized Fair Cost Gains Losses Value June 30, 2021 U.S. government obligations (maturing in one year or less) $ 3,000 $ — $ — $ 3,000 Corporate debt securities (maturing in one year or less) 1,999 — — 1,999 Total marketable securities $ 4,999 $ — $ — $ 4,999 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Prepaid Expenses and Other Current Assets | |
Schedule of prepaid expenses and other current assets | Prepaid expenses and other current assets consist of the following: June 30, December 31, 2021 2020 Prepaid insurance $ 259 $ 680 Other 943 769 Total prepaid expenses and other current assets $ 1,202 $ 1,449 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Accrued Liabilities | |
Schedule of accrued liabilities | June 30, December 31, 2021 2020 Accrued compensation $ 1,397 $ 1,697 Accrued professional fees and other 3,756 1,651 Total accrued liabilities $ 5,153 $ 3,348 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Leases | |
Maturity of lease liabilities | Future minimum lease payments under non-cancellable leases as of June 30, 2021 were as follows: 2021 $ 75 Total $ 75 Less: Interest (3) Present value of lease liability $ 72 |
Credit Agreement and Guaranty (
Credit Agreement and Guaranty (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Credit Agreement and Guaranty | |
Schedule of carrying amount of term loan | June 30, 2021 Notes payable $ 20,000 Debt issuance costs (689) Warrant discount (3,276) Long-term debt $ 16,035 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Stockholders' Equity | |
Schedule of allocation of stock-based compensation expense | Stock-based compensation expense was allocated as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2021 2020 2021 2020 Cost of goods sold $ 75 $ — $ 135 $ — Research and development 121 139 228 337 Selling and marketing 43 26 78 43 General and administrative 604 674 1,144 1,080 Total $ 843 $ 839 $ 1,585 $ 1,460 |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive Income (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Accumulated Other Comprehensive Income Loss Net Of Tax [Abstract] | |
Schedule of change in accumulated other comprehensive income, which is reported as a component of stockholders' equity | The change in accumulated other comprehensive income, which is reported as a component of stockholders’ equity, for the six months ended June 30, 2021 is summarized below (in thousands): Unrealized Gain on Marketable Securities Balance December 31, 2020 $ 3 Other comprehensive income (3) Balance June 30, 2021 $ — |
Organization and Description _2
Organization and Description of Business (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Nature of Operations | ||
Accumulated deficit | $ 346,988 | $ 312,223 |
Cash, cash equivalents and marketable securities | $ 31,100 |
Organization and Description _3
Organization and Description of Busines - Basis of Presentation (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Organization and Description of Business | ||||
Selling and marketing | $ 11,714 | $ 3,150 | $ 20,877 | $ 4,892 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Inventory (Details) - item | 3 Months Ended | 6 Months Ended |
Jun. 30, 2021 | Jun. 30, 2021 | |
Summary of Significant Accounting Policies | ||
Number of units sold | 2,000 | 3,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Property and Equipment and Advertising Costs (Details) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Advertising costs | $ 3 | $ 0 | $ 6.1 | $ 0 |
Manufacturing equipment | ||||
Estimated useful life (in years) | 7 years |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Deferred Financing Costs (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Deferred Financing Costs | ||||
Facility fee percentage | 1.00% | |||
Interest expense [Member] | ||||
Deferred Financing Costs | ||||
Amortization of deferred financing costs | $ 69,000 | $ 69,000 | $ 139,000 | $ 92,000 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Concentrations of Credit Risk (Details) $ in Thousands | 3 Months Ended | 6 Months Ended |
Jun. 30, 2021USD ($)customer | Jun. 30, 2021USD ($) | |
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 | $ 1,185 | $ 1,301 |
Customer Concentration Risk | ||
Concentration risk, financial liabilities | ||
Number of major customers | customer | 3 | |
Customer Concentration Risk | Sales Revenue | Customer One | ||
Concentration risk, financial liabilities | ||
Total revenue | $ 500 | |
Customer Concentration Risk | Sales Revenue | Customer Two | ||
Concentration risk, financial liabilities | ||
Total revenue | 400 | |
Customer Concentration Risk | Sales Revenue | Customer Three | ||
Concentration risk, financial liabilities | ||
Total revenue | $ 300 | |
Customer Concentration Risk | Sales Revenue | Three Customers | ||
Concentration risk, financial liabilities | ||
Concentration risk, percentage | 96.00% | |
Customer Concentration Risk | Accounts Receivable | Customer One | ||
Concentration risk, financial liabilities | ||
Concentration risk, percentage | 41.00% | |
Customer Concentration Risk | Accounts Receivable | Customer Two | ||
Concentration risk, financial liabilities | ||
Concentration risk, percentage | 27.00% | |
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) | 3 Months Ended | 6 Months Ended |
Jun. 30, 2021USD ($) | Jun. 30, 2021USD ($) | |
Receivables [Abstract] | ||
Provision for revenue reserve | $ 345,000 | $ 348,000 |
Reserve for variable consideration | $ 300,000 | $ 300,000 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Warrants (Details) - shares | Feb. 28, 2021 | Feb. 29, 2020 |
Summary of Significant Accounting Policies | ||
Common stock that can be purchased with warrants (in shares) | 450,000 | 1,400,000 |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Income Taxes (Details) $ in Thousands | Jun. 30, 2021USD ($) |
Uncertainty in tax positions | |
Uncertain tax positions | $ 0 |
Summary of Significant Accou_11
Summary of Significant Accounting Policies - Net Loss Per Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Anti-dilutive securities | ||
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 12,456,023 | 10,063,049 |
Common stock warrants | ||
Anti-dilutive securities | ||
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 1,850,000 | 1,400,000 |
Restricted Stock Units | ||
Anti-dilutive securities | ||
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 253,697 | 159,795 |
Common stock options | ||
Anti-dilutive securities | ||
Anti-dilutive securities excluded from the calculation of diluted net loss per share (in shares) | 10,352,326 | 8,503,254 |
Fair Value Measurements - Finan
Fair Value Measurements - Financial Instruments Measured at Fair Value by Hierarchy Level (Details) - Recurring - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Level 1 | ||
Assets: | ||
Cash and cash equivalents | $ 26,118 | $ 14,463 |
Total assets at fair value | 26,118 | 14,463 |
Level 2 | ||
Assets: | ||
Marketable securities | 4,999 | 40,008 |
Total assets at fair value | $ 4,999 | $ 40,008 |
Fair Value Measurements - Trans
Fair Value Measurements - Transfers Between Levels (Details) - USD ($) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2021 | Dec. 31, 2020 | |
Fair value measurements | ||
Asset transfers out of Level 1 into Level 2 | $ 0 | $ 0 |
Asset transfers out of Level 2 into Level 1 | 0 | 0 |
Asset transfers into (out of) Level 3 | 0 | 0 |
Liability transfers out of Level 1 into Level 2 | 0 | 0 |
Liability transfers out of Level 2 into Level 1 | 0 | 0 |
Liability transfers into (out of) Level 3 | $ 0 | $ 0 |
Marketable Securities (Details)
Marketable Securities (Details) $ in Thousands | Jun. 30, 2021USD ($) |
Marketable Securities [Line Items] | |
Amortized Cost (maturing in one year or less) | $ 4,999 |
Fair Value (maturing in one year or less) | $ 4,999 |
Investment-grade marketable securities in a continuous unrealized loss position for more than twelve months | 0 |
Accrued interest | $ 0 |
U.S. government obligations | |
Marketable Securities [Line Items] | |
Amortized Cost (maturing in one year or less) | 3,000 |
Fair Value (maturing in one year or less) | 3,000 |
Corporate debt securities | |
Marketable Securities [Line Items] | |
Amortized Cost (maturing in one year or less) | 1,999 |
Fair Value (maturing in one year or less) | $ 1,999 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Prepaid Expenses and Other Current Assets | ||
Prepaid insurance | $ 259 | $ 680 |
Other | 943 | 769 |
Total prepaid expenses and other current assets | $ 1,202 | $ 1,449 |
Accrued Liabilities (Details)
Accrued Liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Accrued Liabilities | ||
Accrued compensation | $ 1,397 | $ 1,697 |
Accrued professional fees and other | 3,756 | 1,651 |
Total accrued liabilities | $ 5,153 | $ 3,348 |
Leases - Summary (Details)
Leases - Summary (Details) | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2021USD ($)lease | Jun. 30, 2021USD ($)lease | Jun. 30, 2020USD ($) | |
Leases | |||
Number of finance leases | lease | 0 | 0 | |
Number of operating leases | lease | 1 | 1 | |
Operating lease expense | $ | $ 38,000 | $ 75,000 | |
Operating lease expense information: | |||
Cash paid for amounts included in measurement of lease liabilities | $ | $ 34,000 | $ 66,000 | $ 90,000 |
Weighted-average remaining lease term (years) | 6 months | 6 months | |
Weighted-average discount rate | 15.20% | 15.20% |
Leases - Maturity of lease liab
Leases - Maturity of lease liabilities (Details) $ in Thousands | Jun. 30, 2021USD ($) |
Operating Leases | |
2021 | $ 75 |
Total | 75 |
Less: Interest | (3) |
Present value of lease liability | $ 72 |
Credit Agreement and Guaranty_2
Credit Agreement and Guaranty (Details) $ / shares in Units, $ in Thousands | Feb. 26, 2021USD ($)shares | Feb. 10, 2020USD ($)itemY$ / sharesshares | Dec. 31, 2023USD ($) | Jun. 30, 2021USD ($)$ / shares | Jun. 30, 2021$ / shares | Jun. 30, 2020USD ($) | Feb. 28, 2021shares | Feb. 29, 2020shares |
Debt Instrument [Line Items] | ||||||||
Amount borrowed | $ 20,000 | |||||||
Interest rate (as a percent) | 11.75% | 11.75% | 11.75% | |||||
Percentage of annual interest rate | 3.00% | |||||||
Common stock that can be purchased with warrants (in shares) | shares | 450,000 | 1,400,000 | ||||||
Proceeds from warrant exercises | $ 20,000 | |||||||
Facility fee percentage | 1.00% | |||||||
Perceptive Credit Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Percentage of outstanding debt | 1.50% | |||||||
Minimum cash covenants | $ 3,000 | |||||||
Revenue generated under debt | $ 87,100 | $ 3,800 | ||||||
Perceptive Credit Agreement | Perceptive Warrants | ||||||||
Debt Instrument [Line Items] | ||||||||
Exercise price of warrants (in dollars per share) | $ / shares | $ 2.87 | $ 2.87 | ||||||
Common stock that can be purchased with warrants (in shares) | shares | 450,000 | 1,400,000 | ||||||
Number of warrants issued | item | 2 | |||||||
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 | |||||||
Senior secured delayed draw term loan facility | Perceptive Credit Agreement | Perceptive Warrants | ||||||||
Debt Instrument [Line Items] | ||||||||
Maximum borrowing capacity | $ 45,000 | |||||||
Senior secured delayed draw term loan facility | Perceptive Credit Agreement, Tranche One | ||||||||
Debt Instrument [Line Items] | ||||||||
Amount borrowed | 5,000 | |||||||
Senior secured delayed draw term loan facility | Perceptive Credit Agreement, Tranche Two | ||||||||
Debt Instrument [Line Items] | ||||||||
Amount borrowed | 15,000 | |||||||
Senior secured delayed draw term loan facility | Perceptive Credit Agreement, Tranche Three | ||||||||
Debt Instrument [Line Items] | ||||||||
Additional amount available | $ 15,000 | |||||||
Senior secured delayed draw term loan facility | Perceptive Credit Agreement, Tranche Four | ||||||||
Debt Instrument [Line Items] | ||||||||
Amount borrowed | $ 10,000 | |||||||
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 | 8.00% | |||||||
Prepayment Occur on or Before February, 10, 2022 | Perceptive Credit Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Prepayment fee percent | 4.00% | |||||||
Prepayment Occur on or Before February, 10, 2023 | Perceptive Credit Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Prepayment fee percent | 2.00% | |||||||
Two Thousand Twenty Perceptive Warrants [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Fair value of warrants | $ 3,600 | |||||||
Two Thousand Twenty One Perceptive Warrants [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Fair value of warrants | $ 1,100 | |||||||
Option pricing model | Two Thousand Twenty Perceptive Warrants [Member] | Perceptive Warrants | ||||||||
Debt Instrument [Line Items] | ||||||||
Warrants and rights outstanding, term | 7 years | |||||||
Option pricing model | Two Thousand Twenty Perceptive Warrants [Member] | Perceptive Warrants | Volatility | ||||||||
Debt Instrument [Line Items] | ||||||||
Warrants, Measurement Input | item | 0.700 | |||||||
Option pricing model | Two Thousand Twenty Perceptive Warrants [Member] | Perceptive Warrants | Risk free interest rate | ||||||||
Debt Instrument [Line Items] | ||||||||
Warrants, Measurement Input | item | 0.0147 | |||||||
Option pricing model | Two Thousand Twenty Perceptive Warrants [Member] | Perceptive Warrants | Expected life | ||||||||
Debt Instrument [Line Items] | ||||||||
Warrants, Measurement Input | Y | 7 | |||||||
Option pricing model | Two Thousand Twenty Perceptive Warrants [Member] | Perceptive Warrants | Share price [Member] | ||||||||
Debt Instrument [Line Items] | ||||||||
Warrants, Measurement Input | item | 4.01 | |||||||
Option pricing model | Two Thousand Twenty Perceptive Warrants [Member] | Maximum | Perceptive Warrants | Strike price | ||||||||
Debt Instrument [Line Items] | ||||||||
Warrants, Measurement Input | item | 4.67 | |||||||
Option pricing model | Two Thousand Twenty Perceptive Warrants [Member] | Minimum | Perceptive Warrants | Strike price | ||||||||
Debt Instrument [Line Items] | ||||||||
Warrants, Measurement Input | item | 3.74 | |||||||
Option pricing model | Two Thousand Twenty One Perceptive Warrants [Member] | Perceptive Warrants | Volatility | ||||||||
Debt Instrument [Line Items] | ||||||||
Warrants, Measurement Input | item | 1.035 | |||||||
Option pricing model | Two Thousand Twenty One Perceptive Warrants [Member] | Perceptive Warrants | Risk free interest rate | ||||||||
Debt Instrument [Line Items] | ||||||||
Warrants, Measurement Input | item | 0.0115 | |||||||
Option pricing model | Two Thousand Twenty One Perceptive Warrants [Member] | Perceptive Warrants | Strike price | ||||||||
Debt Instrument [Line Items] | ||||||||
Warrants, Measurement Input | item | 2.87 | |||||||
Option pricing model | Two Thousand Twenty One Perceptive Warrants [Member] | Perceptive Credit Agreement | Expected life | ||||||||
Debt Instrument [Line Items] | ||||||||
Warrants, Measurement Input | Y | 7 | |||||||
Warrants and rights outstanding, term | 7 years |
Credit Agreement and Guaranty -
Credit Agreement and Guaranty - Carrying Amount Of term Loan (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Credit Agreement and Guaranty | |||||
Notes payable | $ 20,000,000 | $ 20,000,000 | |||
Debt issuance costs | (689,000) | (689,000) | |||
Warrant discount | (3,276,000) | (3,276,000) | |||
Total | 16,035,000 | 16,035,000 | $ 16,381,000 | ||
Warrants and debt issue costs | $ 398,000 | $ 303,000 | $ 734,000 | $ 404,000 |
Stockholders' Equity - Common S
Stockholders' Equity - Common Stock (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||
Jun. 30, 2021 | Mar. 31, 2021 | Feb. 29, 2020 | Jun. 30, 2021 | Mar. 31, 2021 | Mar. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Oct. 02, 2020 | |
Sale of stock | |||||||||
Commission percentage | 3.00% | ||||||||
2020 Shelf Registration Statement | |||||||||
Sale of stock | |||||||||
Aggregate amount of securities issuable | $ 200,000 | ||||||||
At-the-market sales | |||||||||
Sale of stock | |||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 7,004 | ||||||||
Proceeds from Issuance of Common Stock | $ 7,004 | ||||||||
At-the-market sales | Common Stock | |||||||||
Sale of stock | |||||||||
Issuance of common stock (in shares) | 4,593,034 | 520,937 | 5,113,971 | ||||||
Public offering | |||||||||
Sale of stock | |||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 48,434 | ||||||||
Proceeds from Issuance of Common Stock | $ 48,434 | ||||||||
Public offering | Common Stock | |||||||||
Sale of stock | |||||||||
Issuance of common stock (in shares) | 17,250,000 | 17,250,000 | |||||||
Share price (in dollars per share) | $ 3 | ||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 48,400 | ||||||||
Proceeds from Issuance of Common Stock | $ 48,400 | ||||||||
At The Market Offering | |||||||||
Sale of stock | |||||||||
Proceeds from issuance of common stock in public offering, net of offering costs | $ 7,000 | $ 7,400 | |||||||
Gross Proceeds | $ 50,000 | ||||||||
Proceeds from Issuance of Common Stock | $ 7,000 | $ 7,400 |
Stockholders' Equity - Stock-Ba
Stockholders' Equity - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Stock-Based Compensation Expense | ||||
Total stock-based compensation expense | $ 843 | $ 839 | $ 1,585 | $ 1,460 |
Cost of goods sold | ||||
Stock-Based Compensation Expense | ||||
Total stock-based compensation expense | 75 | 135 | ||
Research and development | ||||
Stock-Based Compensation Expense | ||||
Total stock-based compensation expense | 121 | 139 | 228 | 337 |
Selling and marketing | ||||
Stock-Based Compensation Expense | ||||
Total stock-based compensation expense | 43 | 26 | 78 | 43 |
General and administrative | ||||
Stock-Based Compensation Expense | ||||
Total stock-based compensation expense | $ 604 | $ 674 | $ 1,144 | $ 1,080 |
Accumulated Other Comprehensi_3
Accumulated Other Comprehensive Income (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Accumulated Other Comprehensive Income Loss Net Of Tax [Abstract] | ||||
Balance at beginning of the period | $ 3 | $ 3 | ||
Other comprehensive income of unrealized gain on marketable securities | $ (3) | $ 10 | (3) | $ 10 |
Amounts classified out of accumulated other comprehensive income | $ 0 |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Millions | Jun. 30, 2021USD ($) |
Commitments and Contingencies | |
Future purchase commitments | $ 10.9 |