Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2021 | Jul. 31, 2021 | |
Entity Information [Line Items] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 001-36754 | |
Entity Registrant Name | EVOFEM BIOSCIENCES, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 20-8527075 | |
Entity Address, Address Line One | 12400 High Bluff Drive | |
Entity Address, Address Line Two | Suite 600 | |
Entity Address, City or Town | San Diego | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92130 | |
City Area Code | 858 | |
Local Phone Number | 550-1900 | |
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 | 155,208,456 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
Current Fiscal Year End Date | --12-31 | |
Entity Central Index Key | 0001618835 | |
Common Stock | ||
Entity Information [Line Items] | ||
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Trading Symbol | EVFM | |
Security Exchange Name | NASDAQ | |
Preferred Stock | ||
Entity Information [Line Items] | ||
Title of 12(b) Security | Series A Preferred Stock Purchase Rights, par value $0.0001 per share | |
Security Exchange Name | NASDAQ | |
No Trading Symbol Flag | false |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 46,982 | $ 48,892 |
Restricted cash | 15,206 | 22,559 |
Trade accounts receivable, net | 3,108 | 1,067 |
Inventories | 10,546 | 7,162 |
Prepaid and other current assets | 19,788 | 18,050 |
Total current assets | 95,630 | 97,730 |
Property and equipment, net | 5,950 | 4,334 |
Operating lease right-of-use assets | 6,147 | 6,856 |
Other noncurrent assets | 1,021 | 1,048 |
Total assets | 108,748 | 109,968 |
Current liabilities: | ||
Accounts payable | 7,703 | 10,641 |
Convertible notes payable (Note 5) | 44,308 | 52,409 |
Accrued expenses | 7,495 | 4,476 |
Accrued compensation | 4,272 | 6,514 |
Operating lease liabilities – current | 2,470 | 2,290 |
Other current liabilities | 2,073 | 953 |
Total current liabilities | 68,321 | 77,283 |
Operating lease liabilities – noncurrent | 5,174 | 6,030 |
Long-term convertible notes payable (Note 5) | 26,192 | 25,211 |
Other noncurrent liabilities | 97 | 97 |
Total liabilities | 99,784 | 108,621 |
Commitments and contingencies (Note 8) | ||
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; no shares issued and outstanding | 0 | 0 |
Stockholders’ equity: | ||
Common stock, $0.0001 par value; 300,000,000 shares authorized; 155,136,287 and 81,351,533 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively; | 16 | 8 |
Additional paid-in capital | 744,013 | 656,827 |
Accumulated deficit | (735,065) | (655,488) |
Total stockholders’ equity | 8,964 | 1,347 |
Total liabilities and stockholders’ equity | $ 108,748 | $ 109,968 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (in shares) | 300,000,000 | 300,000,000 |
Common stock, shares issued (in shares) | 155,136,287 | 81,351,533 |
Common stock, shares outstanding (in shares) | 155,136,287 | 81,351,533 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Income Statement [Abstract] | ||||
Product sales, net | $ 1,857 | $ 0 | $ 2,962 | $ 0 |
Operating expenses: | ||||
Cost of goods sold | 839 | 0 | 1,345 | 0 |
Research and development | 8,507 | 2,640 | 15,769 | 6,887 |
Selling and marketing | 27,237 | 9,997 | 57,762 | 17,852 |
General and administrative | 6,416 | 9,735 | 14,100 | 16,877 |
Total operating expenses | 42,999 | 22,372 | 88,976 | 41,616 |
Loss from operations | (41,142) | (22,372) | (86,014) | (41,616) |
Other income (expense): | ||||
Interest income | 4 | 29 | 11 | 131 |
Other expense | (1,186) | (349) | (2,331) | (353) |
Loss on issuance of financial instruments | 0 | (64,049) | 0 | (64,049) |
Change in fair value of financial instruments | 8,910 | 34,075 | 8,768 | 34,075 |
Total other income (expense), net | 7,728 | (30,294) | 6,448 | (30,196) |
Loss before income tax | (33,414) | (52,666) | (79,566) | (71,812) |
Income tax expense | (12) | 0 | (11) | 0 |
Net loss | $ (33,426) | $ (52,666) | $ (79,577) | $ (71,812) |
Net loss per share, basic (in dollars per share) | $ (0.27) | $ (0.91) | $ (0.77) | $ (1.36) |
Net loss per share, diluted (in dollars per share) | $ (0.27) | $ (0.91) | $ (0.77) | $ (1.36) |
Weighted-average shares used to compute net loss per share, basic (in shares) | 125,168,570 | 57,696,519 | 103,625,627 | 52,946,235 |
Weighted-average shares used to compute net loss per share, diluted (in shares) | 125,168,570 | 57,696,519 | 103,625,627 | 52,946,235 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) (Unaudited) - USD ($) $ in Thousands | Total | Public Offering | At The Market (ATM) | Warrants | Common Stock | Common StockPublic Offering | Common StockAt The Market (ATM) | Common StockWarrants | Additional Paid-in Capital | Additional Paid-in CapitalPublic Offering | Additional Paid-in CapitalAt The Market (ATM) | Additional Paid-in CapitalWarrants | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2019 | 48,137,880 | ||||||||||||
Beginning balance at Dec. 31, 2019 | $ 15,636 | $ 5 | $ 528,810 | $ (513,179) | |||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Issuance of common stock (in shares) | 202,098 | ||||||||||||
Issuance of common stock | $ 1,082 | $ 1,082 | |||||||||||
Issuance of common stock - exercise of stock options (in shares) | 19,708 | ||||||||||||
Issuance of common stock - exercise of stock options | 73 | 73 | |||||||||||
Restricted stock awards issued/restricted stock units released (in shares) | 1,286,499 | ||||||||||||
Shares withheld to cover taxes related to vesting of restricted stock awards (in shares) | (4,088) | ||||||||||||
Shares withheld to cover taxes related to vesting of restricted stock awards | (25) | (25) | |||||||||||
Stock-based compensation | 3,401 | 3,401 | |||||||||||
Net loss | (19,146) | (19,146) | |||||||||||
Ending balance (in shares) at Mar. 31, 2020 | 49,642,097 | ||||||||||||
Ending balance at Mar. 31, 2020 | 1,021 | $ 5 | 533,341 | (532,325) | |||||||||
Beginning balance (in shares) at Dec. 31, 2019 | 48,137,880 | ||||||||||||
Beginning balance at Dec. 31, 2019 | 15,636 | $ 5 | 528,810 | (513,179) | |||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Net loss | (71,812) | (71,812) | |||||||||||
Ending balance (in shares) at Jun. 30, 2020 | 81,300,667 | ||||||||||||
Ending balance at Jun. 30, 2020 | 68,539 | $ 8 | 653,522 | (584,991) | |||||||||
Beginning balance (in shares) at Mar. 31, 2020 | 49,642,097 | ||||||||||||
Beginning balance at Mar. 31, 2020 | 1,021 | $ 5 | 533,341 | (532,325) | |||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Issuance of common stock (in shares) | 31,700,000 | 474,558 | 200 | ||||||||||
Issuance of common stock | $ 103,266 | $ 2,280 | $ 3 | $ 103,263 | $ 2,280 | ||||||||
Issuance of common stock - ESPP and exercise of stock options (in shares) | 69,398 | ||||||||||||
Issuance of common stock - ESPP and exercise of stock options | 177 | 177 | |||||||||||
Restricted stock awards issued/restricted stock units released (in shares) | 60,168 | ||||||||||||
Short-swing profit disgorgement | 187 | 187 | |||||||||||
Reclassification from financial instruments liability to equity | 11,015 | 11,015 | |||||||||||
Shares withheld to cover taxes related to vesting of restricted stock awards (in shares) | (645,754) | ||||||||||||
Shares withheld to cover taxes related to vesting of restricted stock awards | (2,777) | (2,777) | |||||||||||
Stock-based compensation | 6,034 | $ 2 | 6,034 | $ 2 | |||||||||
Net loss | (52,666) | (52,666) | |||||||||||
Ending balance (in shares) at Jun. 30, 2020 | 81,300,667 | ||||||||||||
Ending balance at Jun. 30, 2020 | 68,539 | $ 8 | 653,522 | (584,991) | |||||||||
Beginning balance (in shares) at Dec. 31, 2020 | 81,351,533 | ||||||||||||
Beginning balance at Dec. 31, 2020 | 1,347 | $ 8 | 656,827 | (655,488) | |||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Issuance of common stock (in shares) | 17,142,857 | ||||||||||||
Issuance of common stock | 27,709 | $ 2 | 27,707 | ||||||||||
Restricted stock awards issued (in shares) | 1,772,500 | ||||||||||||
Shares withheld to cover taxes related to vesting of restricted stock awards (in shares) | (2,644) | ||||||||||||
Shares withheld to cover taxes related to vesting of restricted stock awards | (7) | (7) | |||||||||||
Stock-based compensation | 3,464 | 3,464 | |||||||||||
Net loss | (46,151) | (46,151) | |||||||||||
Ending balance (in shares) at Mar. 31, 2021 | 100,264,246 | ||||||||||||
Ending balance at Mar. 31, 2021 | (13,638) | $ 10 | 687,991 | (701,639) | |||||||||
Beginning balance (in shares) at Dec. 31, 2020 | 81,351,533 | ||||||||||||
Beginning balance at Dec. 31, 2020 | 1,347 | $ 8 | 656,827 | (655,488) | |||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Net loss | (79,577) | (79,577) | |||||||||||
Ending balance (in shares) at Jun. 30, 2021 | 155,136,287 | ||||||||||||
Ending balance at Jun. 30, 2021 | 8,964 | $ 16 | 744,013 | (735,065) | |||||||||
Beginning balance (in shares) at Mar. 31, 2021 | 100,264,246 | ||||||||||||
Beginning balance at Mar. 31, 2021 | (13,638) | $ 10 | 687,991 | (701,639) | |||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Issuance of common stock (in shares) | 55,119,222 | 49,000 | |||||||||||
Issuance of common stock | $ 53,090 | $ 6 | $ 53,084 | ||||||||||
Restricted stock awards issued (in shares) | 5,000 | ||||||||||||
Issuance of common stock - ESPP and exercise of stock options (in shares) | 173,675 | ||||||||||||
Issuance of common stock - ESPP and exercise of stock options | 196 | 196 | |||||||||||
Restricted stock awards cancelled (in shares) | (124,500) | ||||||||||||
Shares withheld to cover taxes related to vesting of restricted stock awards (in shares) | (350,356) | ||||||||||||
Shares withheld to cover taxes related to vesting of restricted stock awards | (300) | (300) | |||||||||||
Stock-based compensation | 2,993 | $ 49 | 2,993 | $ 49 | |||||||||
Net loss | (33,426) | (33,426) | |||||||||||
Ending balance (in shares) at Jun. 30, 2021 | 155,136,287 | ||||||||||||
Ending balance at Jun. 30, 2021 | $ 8,964 | $ 16 | $ 744,013 | $ (735,065) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (79,577) | $ (71,812) |
Adjustments to reconcile net loss to net cash, cash equivalents and restricted cash used in operating activities: | ||
Loss on issuance of financial instruments | 0 | 64,049 |
Change in fair value of financial instruments | (8,768) | (34,075) |
Stock-based compensation | 6,457 | 9,435 |
Depreciation | 470 | 123 |
Noncash lease expenses | 676 | 364 |
Noncash interest expenses | 1,647 | 344 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (2,041) | 0 |
Inventories | (2,725) | (872) |
Prepaid and other assets | (2,473) | (853) |
Accounts payable | (2,821) | 1,697 |
Accrued expenses and other liabilities | 4,005 | (563) |
Accrued compensation | (2,242) | 2,274 |
Operating lease liabilities | (643) | (39) |
Net cash, cash equivalents and restricted cash used in operating activities | (88,035) | (29,928) |
Cash flows from investing activities: | ||
Proceeds from sale of Softcup line of business | 250 | 250 |
Maturities of short-term investments | 0 | 8,233 |
Purchases of property and equipment | (2,289) | (536) |
Net cash, cash equivalents and restricted cash (used in) provided by investing activities | (2,039) | 7,947 |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock and warrants, net of discounts, fees and commissions - Public Offerings | 81,533 | 103,738 |
Proceeds from issuance of common stock - exercise of warrants | 49 | 2 |
Proceeds from issuance of common stock, net of commissions - ATM transactions | 0 | 3,781 |
Proceeds from issuance of common stock - ESPP and exercise of stock options | 196 | 337 |
Borrowings under convertible notes | 0 | 25,000 |
Short-swing profit disgorgement | 0 | 173 |
Cash paid for financing costs | (660) | (317) |
Payments of tax withholdings related to vesting of restricted stock awards | (307) | (2,802) |
Net cash, cash equivalents and restricted cash provided by financing activities | 80,811 | 129,912 |
Net change in cash, cash equivalents and restricted cash | (9,263) | 107,931 |
Cash, cash equivalents and restricted cash, beginning of period | 72,251 | 16,625 |
Cash, cash equivalents and restricted cash, end of period | 62,988 | 124,556 |
Supplemental disclosure of noncash investing and financing activities: | ||
Right-of-use assets obtained in exchange for operating lease liabilities | 0 | 5,219 |
Financing costs included in accounts payable and accrued expenses | 75 | 550 |
Purchases of property and equipment included in accounts payable and accrued expenses | 203 | 278 |
Reclassification of financial instruments liability to equity | $ 0 | $ 11,015 |
Description of Business and Bas
Description of Business and Basis of Presentation | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business and Basis of Presentation | Description of Business and Basis of Presentation Description of Business Evofem is a San Diego-based, commercial-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women’s sexual and reproductive health, including hormone-free, woman-controlled contraception and protection from certain sexually transmitted infections (STIs). The Company’s first commercial product, Phexxi, was approved by the FDA on May 22, 2020 and is the first and only FDA-approved, hormone-free, woman-controlled, on-demand prescription contraceptive gel for women. The Company commercially launched Phexxi in September 2020. Evofem’s pipeline product candidate, EVO100, is being evaluated for the prevention of chlamydia and gonorrhea in women - two of the most pervasive STIs in the United States. Currently, there are no FDA-approved prescription products for the prevention of either of these dangerous infections. Basis of Presentation and Principles of Consolidation The Company prepared the unaudited interim condensed consolidated financial statements included in this Quarterly Report in accordance with accounting principles generally accepted in the U.S. (GAAP) for interim financial information and the rules and regulations of the Securities and Exchange Commission (SEC) related to quarterly reports on Form 10-Q. The Company’s financial statements are presented on a consolidated basis, which include the accounts of the Company and its wholly-owned subsidiaries. Intercompany accounts and transactions have been eliminated in consolidation. The unaudited interim condensed consolidated financial statements do not include all information and disclosures required by GAAP for annual audited financial statements and should be read in conjunction with the Company’s consolidated financial statements and notes thereto for the year ended December 31, 2020 included in its Annual Report on Form 10-K as filed with the SEC on March 4, 2021 (the 2020 Audited Financial Statements). The unaudited interim condensed consolidated financial statements included in this report have been prepared on the same basis as the Company’s audited consolidated financial statements and include all adjustments (consisting only of normal recurring adjustments) necessary for a fair statement of the financial position, results of operations, cash flows, and statements of convertible preferred stock and stockholders’ deficit for the periods presented. The results for the three and six months ended June 30, 2021 are not necessarily indicative of the results expected for the full year. The condensed consolidated balance sheet as of December 31, 2020 was derived from the 2020 Audited Financial Statements. Risks, Uncertainties and Going Concern We are susceptible to risks and uncertainties associated with the COVID-19 pandemic, which is affecting our employees, customers, communities and business operations, as well as the U.S. and global economies and financial markets. Any disruptions in the commercialization of Phexxi and/or the completion of our clinical trials, data analysis or readouts and/or any disruption in our supply chain could have a material adverse effect on our business, results of operations and financial condition. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19, the success of ongoing COVID-19 vaccination efforts, the emergence, prevalence and strength of variant strains, and the actions taken to contain or treat the disease, as well as the economic impact on local, regional, national and international markets. The condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and settlement of liabilities, in the normal course of business, and does not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or amounts and classification of liabilities that may result from the outcome of this uncertainty. The Company’s principal operations have been related to research and development, including the development of Phexxi, and to its commercially related sales and marketing efforts. Additional activities have included raising capital, recruiting personnel and establishing and maintaining a corporate infrastructure to support a commercial product. The Company has incurred operating losses and negative cash flows from operating activities since inception. As described in Note 5- Convertible Notes and Note 10- Stockholders' Equity (Deficit) , the Company received net proceeds of approximately $81.5 million upon the sale and issuance of common stock and warrants to purchase common stock from two underwritten public offerings that occurred in the first half of 2021, gross proceeds of $50.0 million from the issuance of convertible notes in the second and fourth quarter of 2020, net proceeds of approximately $103.7 million upon the sale and issuance of common stock from an underwritten public offering in June 2020, and $3.8 million from its “at the market” (ATM) program, net of commissions, in 2020. As of June 30, 2021, the Company had cash and cash equivalents of $47.0 million, $14.9 million in restricted cash from the Adjuvant Notes (as defined in Note 5- Convertible Notes ) that is available for use, working capital of $27.3 million and an accumulated deficit of $735.1 million. The Company is subject to risks common to other life science companies in the development and early commercial stage including, but not limited to, uncertainty regarding the commercial success of Phexxi and the development of its pipeline product candidate, EVO100; potential disruption of its research and development and commercialization activities as a result of the COVID-19 pandemic; lack of marketing and sales history; potential development by its competitors of new and competitive technological innovations; dependence on key personnel; market acceptance of Phexxi or any other future approved products, if any; product liability; protection of proprietary technology; ability to raise additional financing; and compliance with the FDA and other government regulations, including post marketing regulations. Management’s plans to meet its short- and long-term operating cash flow requirements include generating recurring product revenue and obtaining additional funding, such as through the issuance of its common stock, non-dilutive financings, or through collaborations or partnerships with other companies. While the Company has recognized limited revenues since the launch of Phexxi in September 2020, the Company anticipates it will continue to incur net losses for the foreseeable future. According to management estimates, liquidity resources as of June 30, 2021 are not sufficient to maintain the Company’s planned level of operations for the twelve months from the date of issuance of these condensed consolidated financial statements. These circumstances and the uncertainties associated with the Company’s ability to obtain additional equity or debt financing on terms that are favorable to the Company, enter into collaborative agreements with strategic partners, and otherwise succeed in its future operations raise substantial doubt about the Company’s ability to continue as a going concern. If the Company is not able to obtain the required funding in the near term, through equity or debt financings or other means, or is unable to obtain funding on terms favorable to the Company, this will have a material adverse effect on its commercialization and development operations and its strategic development plan for future growth. If the Company cannot successfully raise additional funding and implement its strategic development plan, the Company may be forced to make reductions in spending, including spending in connection with its commercialization activities, extend payment terms with suppliers, liquidate assets where possible at a potentially lower amount than as recorded in the condensed consolidated financial statements, suspend or curtail planned operations or cease operations entirely. Any of these could materially and adversely affect its liquidity, financial condition and business prospects and the Company would not be able to continue as a going concern. Subsequent Events Subsequent events were evaluated through the filing date of this Quarterly Report, August 11, 2021. See Note 10- Stockholders' Equity (Deficit) |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Use of Estimates The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and the notes thereto. S ignificant estimates affecting amounts reported or disclosed in the condensed consolidated financial statements include, but are not limited to: the assumptions used in measuring the revenue gross-to-net variable consideration items, the trade accounts receivable credit loss reserve estimate, the discount rate used in estimating the fair value of the lease right - of - use assets and lease liabilities, the assumptions used in estimating the fair value of convertible notes, warrants and purchase rights issued, the useful lives of property and equipment, the recoverability of long-lived assets, clinical trial accruals, the assumptions used in estimating the fair value of stock-based compensation expense and in assessing the probability of achieving certain milestones associated with the performance-based restricted stock awards (Performance-based RSAs). These assumptions are more fully described in Note 3- Revenue , Note 5- Convertible Notes , Note 7- Fair Value of Financial Instruments , Note 8- Commitments and Contingencies , and Note 11- Stock-based Compensation . The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances and adjusts when facts and circumstances dictate. The estimates are the basis for making judgments about the carrying values of assets and liabilities and recorded expenses that are not readily apparent from other sources. As future events and their effects cannot be determined with precision, actual results may materially differ from those estimates or assumptions. Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker, who is the Chief Executive Officer of the Company, in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment. Concentrations of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and restricted cash. Deposits in the Company’s checking, time deposit and investment accounts are maintained in federally insured financial institutions and are subject to federally insured limits or limits set by Securities Investor Protection Corporation. The Company invests in funds through a major U.S. bank and is exposed to credit risk in the event of default to the extent of amounts recorded on the consolidated balance sheets. The Company has not experienced any losses in such accounts and believes it is not exposed to significant concentrations of credit risk on its cash, cash equivalents and restricted cash balances due to the financial position of the depository institutions in which these deposits are held. The Company is also subject to credit risk related to its trade accounts receivable from product sales. Its customers are located in the United States and consist of wholesale distributors, retail pharmacies, and a mail-order specialty pharmacy. The Company extends credit to its customers in the normal course of business after evaluating their overall financial condition and evaluates the collectability of its accounts receivable by periodically reviewing the age of the receivables, the financial condition of its customers, and its past collection experience. Historically, the Company has not experienced any credit losses. As of June 30, 2021, based on the evaluation of these factors the Company did not record an allowance for doubtful accounts. For the three and six months ended June 30, 2021, the Company’s three largest customers combined made up approximately 83% and 85% of its gross product sales, respectively. For the three and six months ended June 30, 2020, the Company had no product sales. As of June 30, 2021 and December 31, 2020, the Company's three largest customers combined made up 85% and 95%, respectively, of its trade accounts receivable balance. Significant Accounting Policies There have been no changes to the significant accounting policies that were described in Note 2- Summary of Significant Accounting Policies to the 2020 Audited Financial Statements during the first quarter of 2021. Cash, Cash Equivalents and Restricted Cash Cash and cash equivalents consist of readily available cash in checking accounts and money market funds. Restricted cash consists of cash held in monthly time deposit accounts and letters of credit, which are collateral for the Company’s credit cards, facility leases and fleet leases as described in Note 8- Commitments and Contingencies . As of June 30, 2021, the Company maintained letters of credit of $0.8 million and $0.3 million for its office lease and fleet leases, respectively. Additionally, the remaining $14.9 million of the $25.0 million received from the issuance of Adjuvant Notes in the fourth quarter of 2020, is classified as restricted cash as the Company is contractually obligated to use the funds for specific purposes. The following table provides a reconciliation of cash, cash equivalents and restricted cash, reported within the condensed consolidated statements of cash flows (in thousands): Six Months Ended June 30, 2021 2020 Cash and cash equivalents $ 46,982 $ 123,556 Restricted cash 15,206 200 Restricted cash included in other noncurrent assets 800 800 Total cash, cash equivalents and restricted cash presented in the condensed consolidated statements of cash flows $ 62,988 $ 124,556 Net Loss Per Share Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, potentially dilutive securities 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. Potentially dilutive securities excluded from the calculation of diluted net loss per share are summarized in the table below. Three and Six Months Ended June 30, 2021 2020 Unvested restricted common stock subject to repurchase 1,006,833 120,000 Common stock to be purchased under the 2019 ESPP 349,835 67,324 Options to purchase common stock 11,086,333 8,449,016 Warrants to purchase common stock 67,877,107 10,426,107 Total 80,320,108 19,062,447 Recently Issued Accounting Pronouncements — Not Yet Adopted In August 2020, the Financial Accounting Standards Board issued ASU No. 2020-06, Debt (ASU No. 2020-06) , removing, modifying and adding certain disclosure requirements of ASC 470, Debt with Conversion and Other Options , and ASC 815, Derivatives and Hedging—Contracts in Entity’s Own Equity. ASU No. 2020-06 will be effective for the Company beginning January 1, 2024. The Company is currently evaluating when to adopt ASU 2020-06 and the expected impact on the condensed consolidated financial statements. |
Revenue
Revenue | 6 Months Ended |
Jun. 30, 2021 | |
Revenue from Contract with Customer [Abstract] | |
Revenue | Revenue The Company recognizes revenue from the sale of Phexxi in accordance with ASC 606, Revenue from Contracts with Customers (ASC 606). The provisions of ASC 606 require the following steps to determine revenue recognition: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; (5) recognize revenue when (or as) the entity satisfies a performance obligation. In accordance with ASC 606, the Company recognizes revenue when its performance obligation is satisfied by transferring control of the product 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 of wholesale distributors, retail pharmacies, and a mail-order specialty pharmacy. Payment terms typically range from 45 to 66 days, include prompt pay discounts, and vary by customer. 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 policy in Note 2- Summary of Significant Accounting Policies to the 2020 Audited Financial Statements. 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 the performance obligation is satisfied. 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. Phexxi is sold to customers at the wholesale acquisition cost (WAC), or in some cases at a discount to WAC. However, the Company records product revenue, net of reserves for applicable variable consideration. These types of variable consideration reduce revenue and include the following: • Distribution services fees • Prompt pay and other discounts • Product returns • Chargebacks • Rebates • Patient support programs, including our co-pay programs An estimate for variable consideration is made with each sale and is recorded in conjunction with the revenue being recognized. To calculate the variable consideration, the Company uses the expected value method. 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 also affect net product revenue and earnings. 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 historical sales data showing the amount of various end-user consumer types, inventory reports from the wholesale distributors and mail-order specialty pharmacy, and other relevant data reports. Because Phexxi was launched in September 2020, this historical data is limited. Due to limits on historical data, the Company has also used trend analysis and professional judgment in developing these estimates. The specific considerations that the Company uses in estimating these amounts related to variable consideration are as follows: Distribution services fees – The Company pays distribution service fees to its wholesale distributors and mail-order specialty pharmacy. These fees are a contractually fixed percentage of WAC, and are calculated at the time of sale based on the purchase amount. The Company considers these fees to be separate from the customer’s purchase of the product, therefore, they are recorded in other current liabilities on the condensed consolidated balance sheet. Prompt pay and other discount s – The Company incentivizes its customers to pay their invoices on time through prompt pay discounts. These discounts are an industry standard practice, and the Company offers a prompt pay discount to each wholesale distributor customer. The specific prompt pay terms vary by customer and are contractually fixed. Prompt pay discounts are typically taken by the Company’s customers, so an estimate of the discount is recorded at the time of sale based on the purchase amount. Prompt pay discount estimates are recorded as contra trade accounts receivable on the condensed consolidated balance sheet. The Company may also give other discounts to its customers to incentivize purchases and promote customer loyalty. The terms of such discounts may vary by customer. These discounts reduce gross product revenue at the time the revenue is recognized. Chargebacks – Certain government entities and covered entities (e.g. Veterans Administration, 340B covered entities) are able to purchase the product at a price discounted below WAC. The difference between the government or covered entity purchase price and the wholesale distributor purchase price of WAC will be charged back to the Company. The Company estimates the amount of each chargeback channel based on the expected number of claims in each channel and related chargeback 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 consolidated balance sheet. Rebates – The Company is subject to mandatory discount obligations under the Medicaid and Tricare programs. The rebate amounts for these programs are determined by statutory requirements or contractual arrangements. Rebates are owed after the product has been dispensed to an end user and the Company has been invoiced. Rebates for Medicaid and Tricare are typically invoiced in arrears. The Company estimates the amount in rebates based on the expected number of claims and related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Rebate estimates are recorded as other current liabilities on the consolidated balance sheet. Patient support programs – One type of patient support program the Company offers is a co-pay program to commercially insured patients whose insurance requires a co-pay to be made when filling their prescription. This is a voluntary program that is intended to provide financial assistance to patients meeting certain eligibility requirements. The Company estimates the amount of financial assistance for these programs 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. Patient support programs estimates are recorded as other current liabilities on the consolidated balance sheet. Product returns – Customers have the right to return product that is within six months or less of the labeled expiration date or that is past the expiration date by no more than six months. Phexxi was commercially launched in September 2020 and there have been minimal returns as of June 30, 2021. The Company uses historical sales and return data to estimate future product returns. Product return estimates are recorded as other current liabilities on the consolidated balance sheet. |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories The inventory costs include all purchased materials, direct labor and manufacturing overhead. Prior to April 2020, costs incurred for the manufacture of Phexxi were recorded as research and development expenses. Inventories consist of the following (in thousands) for the period indicated: June 30, 2021 December 31, 2020 Raw materials $ 508 $ 332 Work in process (1) 2,675 4,162 Finished goods 7,363 2,668 Total $ 10,546 $ 7,162 _____________________ (1) The work in process balance represents all production costs incurred for partially completed goods. |
Convertible Notes
Convertible Notes | 6 Months Ended |
Jun. 30, 2021 | |
Debt Disclosure [Abstract] | |
Convertible Notes | Convertible Notes Baker Bros. Notes On April 23, 2020, the Company entered into a Securities Purchase and Security Agreement (the Baker Bros. Purchase Agreement) with certain affiliates of Baker Bros. Advisors LP, as purchasers (the Baker Purchasers), and Baker Bros. Advisors LP, as designated agent, pursuant to which the Company agreed to issue and sell to the Baker Purchasers (i) convertible senior secured promissory notes (the Baker Notes) in an aggregate principal amount of up to $25.0 million and (ii) warrants to purchase shares of common stock (the Baker Warrants) in a private placement. At the initial closing date of April 24, 2020 (the Baker Initial Closing), the Company issued and sold Baker Notes with an aggregate principal amount of $15.0 million (the Baker First Closing Notes) and Baker Warrants exercisable for 3,073,770 shares of common stock. Following the Baker Initial Closing, the Baker Purchasers had an option to purchase from the Company up to $10.0 million of Baker Notes (the Baker Purchase Rights) at the Baker Purchasers’ discretion at any time prior to the Company receiving at least $100.0 million in aggregate gross proceeds from one or more sales of equity securities. On June 5, 2020 (the Exercise Date), the Baker Purchasers exercised the Baker Purchase Rights. At the second closing date of June 9, 2020 (the Baker Second Closing), the Baker Purchasers acquired the remaining Baker Notes with an aggregate principal amount of $10.0 million and Baker Warrants exercisable for 2,049,180 shares of common stock. With the completion of the underwritten public offering in June 2020 as further discussed in Note 10- Stockholders' Equity (Def i c i t ) , the conversion price of the Baker Notes and the exercise price of the Baker Warrants is $2.44. The Baker Warrants have a five The Baker Notes have a five Interest expense for the three and six months ended June 30, 2021 was approximately $0.7 million and $1.4 million, respectively. The Baker Purchasers elected to have the accrued interest for first quarter of 2021 paid-in-kind, and the accrued interest for the second quarter of 2021 paid in cash. The Baker Notes are convertible at any time at the option of the Baker Purchasers at the conversion price of $2.44 per share. The Baker Notes are callable by the Company on 10 days’ written notice beginning on the third anniversary of the Baker Initial Closing. The call price will equal 100% of the Baker Outstanding Balance plus accrued and unpaid interest if the Company’s common stock as measured using a 30-day volume weighted average price (VWAP) is greater than the benchmark price of $4.99 as stated in the Baker Bros. Purchase Agreement, or 110% of the Baker Outstanding Balance plus accrued and unpaid interest if the VWAP is less than such benchmark price. The Baker Purchasers also have the option to require the Company to repurchase all or any portion of the Baker Notes in cash upon the occurrence of certain events. In a repurchase event, as defined in the Baker Bros. Purchase Agreement, the repurchase price will equal 110% of the Baker Outstanding Balance plus accrued and unpaid interest. In an event of default or the Company’s change of control, the repurchase price will equal to the sum of (x) three times of the Baker Outstanding Balance plus (y) the aggregate value of future interest that would have accrued. Collectively, these options are the “Embedded Features” of the Baker Notes. The Company's stockholders approved the issuance of the shares issuable upon conversion of the Baker Notes and the exercise of the Baker Warrants in order to comply with Nasdaq Listing Rules 5635(b) and 5635(d) at its special meeting of stockholders held on June 18, 2020 (the Approval Date). The Company evaluated whether any of the Embedded Features required bifurcation as a separate component of equity. The Company elected the fair value option (FVO) under ASC 825, Financial Instruments (ASC 825), as the Baker Notes are qualified financial instruments and are, in whole, classified as liabilities. Under the FVO, the Company recognized the hybrid debt instrument at fair value inclusive of the Embedded Features. The Company also determined that the Baker Warrants and the Baker Purchase Rights were free standing financial instruments and were classified as liabilities at the time of issuance in accordance with ASC 480, Distinguishing Liabilities From Equity due to the required stockholders’ approval noted above. Under the valuation methods as described in Note 7- Fair Value Financial Instruments , the Company recorded the following in the condensed consolidated financial statements related to the Baker Notes and Baker Warrants during the quarter ended June 30, 2020: (i) an aggregate of $58.1 million in convertible notes and an aggregate of $46.7 million for warrants and purchase rights liability at the Baker Initial Closing and Exercise Date; (ii) a $64.0 million loss on issuance of financial instruments recognized at the Baker Initial Closing in the condensed consolidated statement of operations; (iii) an aggregate $34.1 million gain on fair value changes of financial instruments as a result of mark-to-market adjustments on the Baker Notes, Baker Warrants and Baker Purchase Rights recognized respectively at the Exercise Date, Approval Date and the quarter ended June 30, 2020, in the condensed consolidated statement of operations; (iv) a $15.8 million reclassification from purchase rights liability to the convertible notes and warrants liability on the Exercise Date; and (v) an $11.0 million reclassification from warrants liability to additional paid-in capital in the condensed consolidated balance sheet on the Approval Date. In addition, the Company concluded that there was no change in the underlying instrument-specific credit risk between the issuance dates for the Baker Notes and June 30, 2021, and, therefore there was no change recognized in the fair value of the convertible notes associated with differences in credit risk that would be presented separately as a component of other comprehensive income. Using the same valuation methods discussed in Note 7- Fair Value Financial Instruments , the Company recorded a $8.9 million gain in fair value changes of financial instruments as a result of mark-to-market adjustments recognized on the Baker Notes for the quarter ended June 30, 2021 in the condensed consolidated financial statements. The Baker Notes contain various customary affirmative and negative covenants agreed to by the Company. The Company was in compliance with all applicable covenants at June 30, 2021. The Baker Notes also include customary events of default as set forth in the Baker Bros. Purchase Agreement, such that, in an event of default, the Baker Purchasers will have the right to accelerate repayment of the aggregate loan balance then outstanding. As of June 30, 2021, the Baker Notes are recorded in the condensed consolidated balance sheet as short-term convertible notes payable with a total balance of $44.3 million. Adjuvant Notes On October 14, 2020, the Company entered into a Securities Purchase Agreement (the Adjuvant Purchase Agreement) with Adjuvant Global Health Technology Fund, L.P., and Adjuvant Global Health Technology Fund DE, L.P. (together, the Adjuvant Purchasers), pursuant to which the Company sold unsecured convertible promissory notes (the Adjuvant Notes) in aggregate principal amount of $25.0 million. The Adjuvant Notes have a five The Adjuvant Notes are convertible, subject to customary 4.99% and 19.99% beneficial ownership limitations, into shares of the Company’s common stock, par value $0.0001 per share, at any time at the option of the Adjuvant Purchasers at a conversion price of $3.65 per share. To the extent not previously prepaid or converted, the Notes will automatically convert into shares of the Company’s common stock at the Conversion Price immediately following the earliest of the time at which the (i) 30-day value-weighted average price of the Company’s common stock is $10.00 per share, or (ii) Company achieves cumulative net sales from the sales of Phexxi of $100,000,000, provided such net sales are achieved prior to July 1, 2022. The Adjuvant Notes contain various customary affirmative and negative covenants agreed to by the Company. The Company was in compliance with all applicable covenants at June 30, 2021. The Adjuvant Notes also include customary events of default as set forth in the Adjuvant Purchase Agreement, such that, in an event of default, the Adjuvant Purchasers will have the right to accelerate repayment of the aggregate loan balance then outstanding. The Adjuvant Notes are accounted for in accordance with authoritative guidance for convertible debt instruments. The $25.0 million in proceeds is considered to be restricted cash for financial reporting purposes due to contractual stipulations that specify the types of expenses the money can be spent on and how it must be allocated. As of June 30, 2021, there is $14.9 million in proceeds remaining that is included in restricted cash on the accompanying consolidated balance sheet. |
Balance Sheet Details
Balance Sheet Details | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Details | Balance Sheet Details Prepaid and other current assets consist of the following (in thousands): June 30, 2021 December 31, 2020 Selling and marketing related costs $ 15,696 $ 15,414 Insurance 2,370 900 Clinical trial related costs 490 304 Subscriptions for IT platforms 258 — Manufacturing related costs 198 382 Flex note receivable (1) — 250 Other 776 800 Total $ 19,788 $ 18,050 _______________________ (1) In July 2016, the Company entered into an Asset Purchase Agreement with The Flex Company (Flex), whereby Flex would acquire certain assets and assume certain liabilities associated with the Company’s Softcup line of business (Softcup). Total consideration for the Softcup sale was $1.9 million, with $0.6 million received in cash at closing and the remaining $1.3 million due and payable under a note in favor of the Company (the Flex Note) through January 1, 2021 (the Maturity Date). The Flex Note bears simple interest at a rate of 5.0% per annum on the remaining principal amount outstanding. An annual principal payment of approximately $0.3 million and the annual accrued and unpaid interest are payable each January 1, beginning in 2017 through the Flex Maturity Date. The note was paid off on January 4, 2021. The Flex Note is secured by the Softcup assets and has been recorded at fair value. The Company’s incremental borrowing rate and the stated interest rate of the Flex Note are materially consistent. Property and Equipment, Net Property and equipment, net, consists of the following (in thousands): Useful Life June 30, 2021 December 31, 2020 Research and production equipment 5 years $ 623 $ 623 Computer equipment and software 3 years 497 444 Office furniture 5 years 881 629 Leasehold improvements 5 years or less 3,489 1,540 Construction in-process — 2,081 2,249 7,571 5,485 Less: accumulated depreciation (1,621) (1,151) Total, net $ 5,950 $ 4,334 Depreciation expense was approximately $0.3 million and $0.1 million for the three months ended June 30, 2021 and 2020, respectively. Depreciation expense was approximately $0.5 million and $0.1 million for the six months ended June 30, 2021 and 2020, respectively. Other Noncurrent Assets Other noncurrent assets consist of the following (in thousands): June 30, 2021 December 31, 2020 Restricted cash included in noncurrent assets $ 800 $ 800 Prepaid directors & officers' insurance 162 214 Other 59 34 Total $ 1,021 $ 1,048 Accrued Expenses Accrued expenses consist of the following (in thousands): June 30, 2021 December 31, 2020 Clinical trial related costs $ 4,264 $ 1,417 Selling and marketing related costs 1,808 564 Legal and other professional fees 935 1,631 Manufacturing related costs 219 498 Other 269 366 Total $ 7,495 $ 4,476 |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The fair values of the Company’s assets, including the money market funds, investments in marketable fixed income debt securities classified as cash and cash equivalents, restricted cash, Flex Note receivable, and the Baker Notes, measured on a recurring basis are summarized in the following tables, as applicable (in thousands): June 30, 2021 Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs Money market funds (1) $ 60,815 $ 60,815 $ — $ — Total assets $ 60,815 $ 60,815 $ — $ — Convertible notes payable (2) $ 44,308 $ — $ — $ 44,308 Total liabilities $ 44,308 $ — $ — $ 44,308 December 31, 2020 Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs Money market funds (1) $ 53,485 $ 53,485 $ — $ — Fixed income debt securities classified as cash and cash equivalents 16,498 16,498 — — Flex note receivable 250 — 250 — Total assets $ 70,233 $ 69,983 $ 250 $ — Convertible notes payable (2) $ 50,752 $ — $ — $ 50,752 Total liabilities $ 50,752 $ — $ — $ 50,752 The Baker Warrants and the Baker Purchase Rights, as discussed in Note 5- Convertible Notes , were determined to be classified as liabilities. Therefore, they were stated at fair value at issuance and subject to mark-to-market at each reporting date until a subsequent event occurs that would change their classification. They were considered Level 3 instruments because the fair value measurement was based, in part, on significant inputs not observed in the market. The following tables summarize the changes in Level 3 financial liabilities measured at fair value on a recurring basis for the three and six months ended June 30, 2021. Baker First Closing Notes Baker Second Closing Notes Total Balance at March 31, 2021 $ 30,536 $ 20,358 $ 50,894 Change in fair value (3) (3,951) (2,635) (6,586) Balance at June 30, 2021 $ 26,585 $ 17,723 $ 44,308 Baker First Closing Notes Baker Second Closing Notes Total Balance at December 31, 2020 (2) $ 30,451 $ 20,301 $ 50,752 Change in fair value (3) (3,866) (2,578) (6,444) Balance at June 30, 2021 $ 26,585 $ 17,723 $ 44,308 _____________________ (1) Included as a component of cash and cash equivalents and restricted cash on the accompanying condensed consolidated balance sheet. (2) The convertible notes payable as of December 31, 2020 on the accompanying condensed consolidated balance sheet also includes approximately $1.7 million in accrued interest on the Baker Notes. (3) The total change in fair value on the accompanying condensed consolidated statement of operations for the three and six months ended June 30, 2021 includes approximately $2.3 million in accrued interest settled in kind. The following tables summarize the changes in Level 3 financial liabilities measured at fair value on a recurring basis for the six months ended June 30, 2020. There was no activity in the first quarter of 2020. Baker First Closing Notes Baker Second Closing Notes Baker First Closing Warrants Baker Purchase Rights Baker Second Closing Warrants Total Balance at December 31, 2019 $ — $ — $ — $ — $ — $ — Initial liability at issuance 37,405 20,715 14,007 27,636 5,098 104,861 Change in fair value (11,030) (3,132) (7,408) (11,823) (682) (34,075) Reclassification from liability to equity (6,599) — (4,416) (11,015) Exercise of Baker Purchase Rights for convertible notes — (10,715) — (10,715) Exercise of Baker Purchase Rights for warrants — (5,098) — (5,098) Balance at June 30, 2020 $ 26,375 $ 17,583 $ — $ — $ — $ 43,958 Baker Notes The fair value of the Baker Notes issued as described in Note 5- Convertible Notes , and subsequent changes in fair value recorded at the June 30, 2021 reporting date, were determined using a Monte Carlo simulation-based model. Monte Carlo simulation was used to take into account several factors including the future value of the Company's common stock, a potential change of control event, the maturity term of the Baker Notes, the probability of an event of voluntary conversion of the Baker Notes, exercise of the put right, and exercise of the Company's call right. Baker Warrants The fair value of the Baker Warrants issued during the second quarter of 2020 as described in Note 5- Convertible Notes , and the respective changes in fair value of these warrants as a result of mark-to-market, were determined using the Black-Scholes option pricing model based on the following weighted-average assumptions for the period indicated. Three and Six Months Ended June 30, 2020 Expected volatility 93.7 % Risk-free interest rate 0.4 % Expected dividend yield — % Expected term (years) 4.9 Baker Purchase Rights |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Operating Leases Fleet Leases In December 2019, the Company and Enterprise FM Trust (the Lessor) entered into a Master Equity Lease Agreement whereby the Company leases vehicles to be delivered by the Lessor from time to time with various monthly costs depending on the vehicles delivered for a term of 24 or 36 months, commencing on each corresponding delivery date. The leased vehicles are for use by eligible employees of the Company's commercial operations personnel. There was a total of 74 leased vehicles as of June 30, 2021. The Company maintains a letter of credit as collateral in favor of the Lessor, which was included in restricted cash in the condensed consolidated balance sheet. As of June 30, 2021 and December 31, 2020, this letter of credit was $0.3 million. The Company determined that the leased vehicles are accounted for as operating leases under ASC 842, Leases . 2020 Lease and the First Amendment On October 3, 2019, the Company entered into an office lease for approximately 24,474 square feet (Existing Premises) pursuant to a non-cancelable lease agreement (the 2020 Lease). The 2020 Lease commenced on April 1, 2020 and will expire on September 30, 2025, unless terminated earlier in accordance with its terms. The Company has a right to extend the term of the lease for an additional five years and does not anticipate exercising such extension. The Company provided the landlord with a $750,000 security deposit in the form of a letter of credit for the Existing Premises. On April 14, 2020, the Company entered into the first amendment to the 2020 Lease for an additional 8,816 rentable square feet of the same office location (the Expansion Premises), which commenced on September 1, 2020 and will expire on September 30, 2025. The Company provided an additional $50,000 in a letter of credit for the Expansion Premises. As of June 30, 2021 and December 31, 2020, restricted cash maintained as collateral for the Company’s security deposit was $0.8 million. 2015 Lease Effective January 30, 2015, the Company entered into a sublease for office space under a noncancelable lease agreement that expired in March 2020 (the 2015 Lease), which is the Company’s primary office space. The 2015 Lease expired on March 31, 2020. Supplemental Financial Statement Information Three Months Ended June 30, Six Months Ended June 30, Lease Cost (in thousands) Classification 2021 2020 2021 2020 Operating lease expense Research and development $ 128 $ 105 $ 272 $ 155 Operating lease expense Selling and marketing 251 76 497 131 Operating lease expense General and administrative 205 171 408 246 Total $ 584 $ 352 $ 1,177 $ 532 Lease Term and Discount Rate June 30, 2021 December 31, 2020 Weighted Average Remaining Lease Term (in years) 4.00 4.43 Weighted Average Discount Rate 12 % 12 % Maturity of Operating Lease Liabilities (in thousands) June 30, 2021 Remainder of 2021 $ 1,307 Year ending December 31, 2022 2,497 Year ending December 31, 2023 2,166 Year ending December 31, 2024 2,192 Year ending December 31, 2025 1,502 Total lease payments 9,664 Less: imputed interest (2,020) Total $ 7,644 Six Months Ended June 30, Other information (in thousands) 2021 2020 Cash paid for amounts included in the measurement of lease liabilities: Operating cash outflows in operating leases $ 1,139 $ 225 Other Contractual Commitments In November 2019, the Company entered into a supply and manufacturing agreement with a third-party to manufacture Phexxi and potentially other product candidates in accordance with all applicable current good manufacturing practice regulations, pursuant to which the Company has certain minimum purchase commitments based on the forecasted product sales. Contingencies From time to time the Company may be involved in various lawsuits, legal proceedings or claims that arise in the ordinary course of business. There were no claims or actions pending against the Company as of June 30, 2021 and December 31, 2020, which management believes would have, individually or in the aggregate, a material adverse effect on its business, liquidity, financial position, results of operations or cash flows. However, litigation is subject to inherent uncertainties and an adverse result in any matter that may arise from time to time could harm the Company’s business. Intellectual Property Rights In 2014, the Company entered into an amended and restated license agreement (the Rush License Agreement) with Rush University Medical Center (Rush University) pursuant to which Rush University granted the Company an exclusive, worldwide license of certain patents and know-how related to its multipurpose vaginal pH modulator technology. Pursuant to the Rush License Agreement, the Company is obligated to pay to Rush University an earned royalty based upon a percentage of net sales in the range of mid-single digits. In September 2020, the Company entered the first amendment to the Rush License Agreement, pursuant to which the Company is also obligated to pay a minimum annual royalty amount of $100,000 to the extent the earned royalties do not equal or exceed $100,000 commencing January 1, 2021. Such royalty payments were $0.1 million for the three and six months ended June 30, 2021. |
Related-party Transactions
Related-party Transactions | 6 Months Ended |
Jun. 30, 2021 | |
Related Party Transactions [Abstract] | |
Related-party Transactions | Related-party Transactions Consulting Agreements Effective April 1, 2019, the Company entered into a two |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Stockholders' Equity (Deficit) | Stockholders' Equity (Deficit) Warrants In April and June 2020, pursuant to the Baker Bros. Purchase Agreement as discussed in Note 5- Convertible Notes As of June 30, 2021, warrants to purchase up to 67,877,107 shares of the Company’s common stock remain outstanding at a weighted average exercise price of $1.54 per share. These warrants are summarized below: Type of Warrants Underlying Common Stock to be Purchased Exercise Price Issue Date Exercise Period Common Warrants 878 $ 51.24 March 30, 2012 March 30, 2012 to March 30, 2022 Common Warrants 1,171 $ 51.24 August 17, 2012 August 17, 2012 to July 17, 2022 Common Warrants 7,806 $ 3.69 June 11, 2014 June 11, 2014 to June 11, 2024 Common Warrants 848,674 $ 7.50 May 24, 2018 May 24, 2018 to May 24 2025 Common Warrants 182 $ 7.50 June 26, 2018 June 26, 2018 to June 26, 2025 Common Warrants 1,666,667 $ 6.38 April 11, 2019 October 11, 2019 to April 11, 2026 Common Warrants 2,777,779 $ 6.38 June 10, 2019 December 10, 2019 to June 10, 2026 Common Warrants 3,073,770 $ 2.44 April 24, 2020 April 24, 2020 to April 24, 2025 Common Warrants 2,049,180 $ 2.44 June 9, 2020 June 9, 2020 to June 9, 2025 Common Warrants 57,451,000 $ 1.00 May 20, 2021 May 20, 2021 to May 22, 2023 Total 67,877,107 Common Stock Effective January 17, 2018, the Company amended and restated its certificate of incorporation, under which the Company is currently authorized to issue up to 300,000,000 shares of common stock, $0.0001 par value per share, and 5,000,000 shares of preferred stock, $0.0001 par value per share. Public Offerings On June 5, 2020, the Company completed an underwritten public offering (the 2020 Public Offering), whereby the Company issued 28,500,000 shares of common stock at a price to the public of $3.50 per share (the 2020 Public Offering Price). The Company received proceeds from the 2020 Public Offering of $93.2 million, net of underwriting discounts. In addition, the Company granted the underwriters a 30-day option to purchase up to an additional 4,275,000 shares of its common stock at the 2020 Public Offering Price, less applicable underwriting discounts. On June 10, 2020, the Company issued an additional 3,200,000 shares of common stock upon exercise of the underwriters’ option and received $10.5 million in proceeds from this exercise, net of underwriting discounts. The common stock issued in the 2020 Public Offering were registered pursuant to a shelf registration statement on Form S-3 filed with the SEC on November 18, 2019 and declared effective on December 2, 2019. On March 29, 2021, the Company completed an underwritten public offering (the March 2021 Public Offering), whereby the Company issued 17,142,857 shares of common stock at a price to the public of $1.75 per share (the March 2021 Public Offering Price). The Company received proceeds from the March 2021 Public Offering of approximately $28.0 million, net of underwriting discounts. In addition, the Company granted the underwriters a 30-day overallotment option to purchase up to an additional 2,571,428 shares of its common stock at the March 2021 Public Offering Price, less applicable underwriting discounts. On April 6, 2021, the underwriters exercised their overallotment option in full and the Company received proceeds of approximately $4.2 million, net of underwriting discounts. The common stock issued in the March 2021 Public Offering were registered pursuant to a shelf registration statement on Form S-3 filed with the SEC on March 4, 2021 and declared effective on March 11, 2021. On May 20, 2021, the Company completed an underwritten public offering (the May 2021 Public Offering), whereby the Company issued 50,000,000 shares of common stock at a price to the public of $1.00 per share and accompanying common warrants to purchase 50,000,000 shares of common stock. The common warrants have an exercise price of $1.00 per share and can be exercised any time through May 22, 2023. The Company received proceeds from the May 2021 Public Offering of approximately $46.8 million, net of underwriting discounts and fees. In addition, the Company granted the underwriters a 30-day overallotment option to purchase up to an additional 7,500,000 shares of its common stock at $0.99 per share, less applicable underwriting discounts, and/or common warrants to purchase 7,500,000 shares of common stock, at $0.01 per warrant, less applicable underwriting discounts. On May 20, 2021, the underwriters exercised their overallotment option to purchase warrants in full and the Company received proceeds of approximately $0.1 million, net of underwriting discounts. On May 21, 2021, the underwriters exercised their overallotment option to purchase common stock and the Company issued an additional 2,547,794 shares of common stock and received proceeds of approximately $2.4 million, net of underwriting discounts. The common stock issued in the May 2021 Public Offering were registered pursuant to a shelf registration statement on Form S-3 filed with the SEC on March 4, 2021 and declared effective on March 11, 2021. ATM Program In November 2019, the Company entered into an Equity Distribution Agreement (the Equity Distribution Agreement) with Piper Sandler & Co. (Piper Sandler), which provided the Company the ability to offer and sell, from time to time, shares of its common stock in ATM offerings (as defined in Rule 415 of the Securities Act of 1933, as amended) having an aggregate offering price up to $50 million through Piper Sandler acting as sales agent. On June 2, 2020, in connection with the aforementioned 2020 Public Offering, the Equity Distribution Agreement was terminated. During the six months ended June 30, 2021, the Company received no proceeds from the ATM program. During the six months ended June 30, 2020, the Company received proceeds of approximately $3.8 million in cash and cash equivalents (including $0.3 million that was included in other receivables in the condensed consolidated balance sheet at December 31, 2019), net of commissions, from the sale of 676,656 shares of its common stock. Common Stock Reserved for Future Issuance Common stock reserved for future issuance is as follows in common equivalent shares as of June 30, 2021: Common stock issuable upon the exercise of stock options outstanding 11,086,333 Common stock issuable upon the exercise of common stock warrants 67,877,107 Common stock available for future issuance under the 2019 ESPP 2,120,046 Common stock available for future issuance under the Amended and Restated 2014 Plan 1,386,769 Common stock available for future issuance under the Amended Inducement Plan 679,508 Total common stock reserved for future issuance 83,149,763 |
Stock-based Compensation
Stock-based Compensation | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Stock-based Compensation | Stock-based Compensation Equity Incentive Plans The following table summarizes stock-based compensation expense related to stock options, restricted stock awards (RSAs) and RSUs granted to employees, non-employee directors and consultants, and Employee Stock Purchase Plan included in the condensed consolidated statements of operations as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Research and development $ 419 $ 916 $ 962 $ 1,398 Selling and marketing 609 1,121 1,349 1,659 General and administrative 1,965 3,997 4,146 6,378 Total $ 2,993 $ 6,034 $ 6,457 $ 9,435 The 2012 Equity Incentive Plan (the 2012 Plan) provides for the issuance of RSAs, RSUs, or non-qualified and incentive common stock options to its employees, non-employee directors and consultants, from its authorized shares. In general, the options expire ten four three On September 15, 2014, the Company's board of directors adopted, and stockholders approved, the 2014 Equity Incentive Plan (the 2014 Plan), which was amended and restated on each of May 2018 and February 26, 2019 (the Amended and Restated 2014 Plan), which among other things, increased the number of authorized shares under the 2014 Plan from 749,305 to an aggregate of 7,800,000 shares. On February 25, 2020, the Company’s board of directors approved, subject to stockholder approval, and recommended its stockholders approve at the 2020 Annual Meeting, an additional 2,000,000 authorized shares reserved for issuance under the Amended and Restated 2014 Plan to an aggregate of 11,725,515 shares, including the Evergreen Shares discussed below. Such stockholder approval was obtained on May 12, 2020. Per the terms of the Amended and Restated 2014 Plan, the shares reserved will automatically increase on each January 1 through 2024, by an amount equal to the smaller of (i) 4% of the number of shares of common stock issued and outstanding on the immediately preceding December 31; or (ii) an amount determined by our board of directors. This provision resulted in an additional 3,254,061 shares (Evergreen Shares) added to the total number of authorized shares on January 1, 2021. On July 24, 2018, upon the recommendation by the Compensation Committee, the Company's board of directors adopted the Evofem Biosciences, Inc. 2018 Inducement Equity Incentive Plan (the Inducement Plan), pursuant to which the Company reserved 250,000 shares for the issuance of equity awards under the Inducement Plan. The Inducement Plan was amended effective February 25, 2020 (the Amended Inducement Plan), which increased the number of authorized shares to an aggregate of 1,250,000 shares. The only persons eligible to receive awards under the Inducement Plan are individuals who satisfy the standards for inducement grant recipients under Nasdaq Marketplace Rule 5635(c)(4), generally, a person not previously an employee or director of the Company, or following a bona fide period of non-employment, as an inducement material to the individual’s entering into employment with the Company. Stock Options There were 578,500 and 767,000 shares of stock options granted during the three months ended June 30, 2021 and 2020, respectively, and 3,056,525 and 2,242,485 shares of stock options granted during the six months ended June 30, 2021 and 2020, respectively. As of June 30, 2021, unrecognized stock-based compensation expense for employee stock options was approximately $11.1 million, which the Company expects to recognize over a weighted-average remaining period of 2.6 years, assuming all unvested options become fully vested. Summary of Assumptions The fair value of noncash stock-based compensation for stock options granted to employees and non-employees was estimated on the date of grant using the Black-Scholes option pricing model based on the following weighted-average assumptions for options granted for the periods indicated. Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Expected volatility 104.1 % 80.7 % 101.1 % 80.1 % Risk-free interest rate 1.0 % 0.4 % 0.7 % 0.6 % Expected dividend yield — % — % — % — % Expected term (years) 5.5 5.9 5.9 5.9 Expected volatility. The expected volatility assumption is based on volatilities of a peer group of similar companies whose share prices are publicly available. The peer group was developed based on companies in the biotechnology industry. Risk-free interest rate. The risk-free interest rate assumption is based on observed interest rates appropriate for the expected term of the stock option grants. Expected dividend yield. The expected dividend yield assumption is based on the fact that the Company has never paid cash dividends and has no present intention to pay cash dividends. Expected term. The expected term represents the period options are expected to be outstanding. Because the Company does not have historical exercise behavior, it determines the expected term assumption using the practical expedient as provided for under ASC 718, Compensation-Stock Compensation , which is the midpoint between the requisite service period and the contractual term of the option. Restricted Stock Awards and Units There were 5,000 and 20,000 shares of RSAs granted under the Amended and Restated 2014 Plan during the three months ended June 30, 2021 and 2020, respectively, and 1,777,500 and 1,265,000 shares of RSAs granted during the six months ended June 30, 2021, and 2020, respectively, to the Company's executive management team, certain non-executive employees and consultants. The vesting conditions for 1,767,500 shares of RSAs granted during the first quarter of 2021 and all of the RSAs granted during the first quarter of 2020 are connected to the Company’s achievement of certain performance milestones in the corresponding fiscal year. For the Performance-based RSAs, (i) the fair value of the award is determined on the grant date, (ii) the Company assesses the probability of achieving each individual milestone associated with the award using reasonable assumptions based on the Company's operation performance towards each milestone, (iii) the fair value of the shares subject to the milestone is expensed over the implicit service period commencing once management believes the performance criteria is probable of being met and (iv) the Company reassesses the probability of achieving each individual milestone at each reporting date, and any change in estimate is accounted for through a cumulative adjustment in the period when the change in estimate occurs. The non-performance based RSAs and RSUs are valued at the fair value on the grant date and the associated expenses will be recognized over the vesting period. For the three and six months ended June 30, 2021, the Company recognized $1.3 million and $2.9 million, respectively, in noncash stock-based compensation expense related to RSAs. For the three and six months ended June 30, 2020, the Company recognized $4.4 million and 6.4 million, respectively, in noncash stock-based compensation expense related to RSAs and RSUs. As of June 30, 2021, unrecognized noncash stock-based compensation expense related to the unvested RSAs was approximately $0.6 million, which the Company expects to recognize over a weighted-average remaining period of 0.6 years. Employee Stock Purchase Plan On May 7, 2019, the board of directors approved a 2019 Employee Stock Purchase Plan (the 2019 ESPP), which was approved by stockholders at the 2019 annual meeting held on June 5, 2019. The 2019 ESPP initially authorized the issuance of 500,000 shares of common stock pursuant to purchase rights granted to employees. In addition, the number of shares available for issuance under the 2019 ESPP will increase on January 1 of each year in an amount equal to the lesser of (i) 1,000,000 shares, (ii) 2% of the shares of common stock outstanding on December 31, or (iii) such lesser number of shares as is determined by the board of directors. This provision resulted in an additional 1,000,000 shares added to the total number of authorized shares on January 1, 2021. The 2019 ESPP is intended to qualify as an employee stock purchase plan within the meaning of Section 423 of the Internal Revenue Code of 1986, as amended. The 2019 ESPP enables eligible full-time and part-time employees to purchase shares of the Company’s common stock through payroll deductions of between 1% and 15% of eligible compensation during an offering period. A new offering period begins approximately every June 15 and December 15. At the last business day of each offering period, the accumulated contributions made during the offering period will be used to purchase shares. The purchase price is 85% of the lesser of the fair market value of the common stock on the first or the last business day of an offering period. The maximum number of shares of common stock that may be purchased by any participant during an offering period will be equal to $25,000 divided by the fair market value of the common stock on the first business day of an offering period. The current active offering period under the 2019 ESPP commenced on June 15, 2021 and will end on December 14, 2021. During the three and six months ended June 30, 2021 and 2020, there were 173,675 and 67,454 shares of common stock purchased under the 2019 ESPP, respectively. The fair value of shares to be issued to employees under the 2019 ESPP is estimated using a Black-Scholes option-pricing model at the grant date, which requires the use of subjective and complex assumptions, including (i) the expected stock price volatility, (ii) the calculation of the expected term of the award, (iii) the risk-free interest rate and (iv) the expected dividend yield. The following weighted average assumptions were used in the calculation of fair value of shares under the 2019 ESPP at the grant dates for the period indicated. Three and Six Months Ended June 30, 2021 2020 Expected volatility 106.9 % 108.9 % Risk-free interest rate 0.1 % 0.2 % Expected dividend yield — % — % Expected term (years) 0.5 0.5 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | The Company prepared the unaudited interim condensed consolidated financial statements included in this Quarterly Report in accordance with accounting principles generally accepted in the U.S. (GAAP) for interim financial information and the rules and regulations of the Securities and Exchange Commission (SEC) related to quarterly reports on Form 10-Q. |
Principles of Consolidation | The Company’s financial statements are presented on a consolidated basis, which include the accounts of the Company and its wholly-owned subsidiaries. Intercompany accounts and transactions have been eliminated in consolidation. The unaudited interim condensed consolidated financial statements do not include all information and disclosures required by GAAP for annual audited financial statements and should be read in conjunction with the Company’s consolidated financial statements and notes thereto for the year ended December 31, 2020 included in its Annual Report on Form 10-K as filed with the SEC on March 4, 2021 (the 2020 Audited Financial Statements). The unaudited interim condensed consolidated financial statements included in this report have been prepared on the same basis as the Company’s audited consolidated financial statements and include all adjustments (consisting only of normal recurring adjustments) necessary for a fair statement of the financial position, results of operations, cash flows, and statements of convertible preferred stock and stockholders’ deficit for the periods presented. The results for the three and six months ended June 30, 2021 are not necessarily indicative of the results expected for the full year. The condensed consolidated balance sheet as of December 31, 2020 was derived from the 2020 Audited Financial Statements. |
Subsequent Events | Subsequent Events Subsequent events were evaluated through the filing date of this Quarterly Report, August 11, 2021. See Note 10- Stockholders' Equity (Deficit) |
Use of Estimates | Use of Estimates The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and the notes thereto. S ignificant estimates affecting amounts reported or disclosed in the condensed consolidated financial statements include, but are not limited to: the assumptions used in measuring the revenue gross-to-net variable consideration items, the trade accounts receivable credit loss reserve estimate, the discount rate used in estimating the fair value of the lease right - of - use assets and lease liabilities, the assumptions used in estimating the fair value of convertible notes, warrants and purchase rights issued, the useful lives of property and equipment, the recoverability of long-lived assets, clinical trial accruals, the assumptions used in estimating the fair value of stock-based compensation expense and in assessing the probability of achieving certain milestones associated with the performance-based restricted stock awards (Performance-based RSAs). These assumptions are more fully described in Note 3- Revenue , Note 5- Convertible Notes , Note 7- Fair Value of Financial Instruments , Note 8- Commitments and Contingencies , and Note 11- Stock-based Compensation . The Company bases its estimates on historical |
Segment Reporting | Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker, who is the Chief Executive Officer of the Company, in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment. |
Concentrations of Credit Risk | Concentrations of Credit Risk Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and restricted cash. Deposits in the Company’s checking, time deposit and investment accounts are maintained in federally insured financial institutions and are subject to federally insured limits or limits set by Securities Investor Protection Corporation. The Company invests in funds through a major U.S. bank and is exposed to credit risk in the event of default to the extent of amounts recorded on the consolidated balance sheets. The Company has not experienced any losses in such accounts and believes it is not exposed to significant concentrations of credit risk on its cash, cash equivalents and restricted cash balances due to the financial position of the depository institutions in which these deposits are held. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash Cash and cash equivalents consist of readily available cash in checking accounts and money market funds. Restricted cash consists of cash held in monthly time deposit accounts and letters of credit, which are collateral for the Company’s credit cards, facility leases and fleet leases as described in Note 8- Commitments and Contingencies |
Net Loss Per Share | Net Loss Per ShareBasic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, potentially dilutive securities 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. |
Recently Issued Accounting Pronouncements - Not Yet Adopted | Recently Issued Accounting Pronouncements — Not Yet Adopted In August 2020, the Financial Accounting Standards Board issued ASU No. 2020-06, Debt (ASU No. 2020-06) , removing, modifying and adding certain disclosure requirements of ASC 470, Debt with Conversion and Other Options , and ASC 815, Derivatives and Hedging—Contracts in Entity’s Own Equity. ASU No. 2020-06 will be effective for the Company beginning January 1, 2024. The Company is currently evaluating when to adopt ASU 2020-06 and the expected impact on the condensed consolidated financial statements. |
Revenue | The Company recognizes revenue from the sale of Phexxi in accordance with ASC 606, Revenue from Contracts with Customers (ASC 606). The provisions of ASC 606 require the following steps to determine revenue recognition: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; (5) recognize revenue when (or as) the entity satisfies a performance obligation. In accordance with ASC 606, the Company recognizes revenue when its performance obligation is satisfied by transferring control of the product 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 of wholesale distributors, retail pharmacies, and a mail-order specialty pharmacy. Payment terms typically range from 45 to 66 days, include prompt pay discounts, and vary by customer. 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 policy in Note 2- Summary of Significant Accounting Policies to the 2020 Audited Financial Statements. 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 the performance obligation is satisfied. 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. Phexxi is sold to customers at the wholesale acquisition cost (WAC), or in some cases at a discount to WAC. However, the Company records product revenue, net of reserves for applicable variable consideration. These types of variable consideration reduce revenue and include the following: • Distribution services fees • Prompt pay and other discounts • Product returns • Chargebacks • Rebates • Patient support programs, including our co-pay programs An estimate for variable consideration is made with each sale and is recorded in conjunction with the revenue being recognized. To calculate the variable consideration, the Company uses the expected value method. 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 also affect net product revenue and earnings. 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 historical sales data showing the amount of various end-user consumer types, inventory reports from the wholesale distributors and mail-order specialty pharmacy, and other relevant data reports. Because Phexxi was launched in September 2020, this historical data is limited. Due to limits on historical data, the Company has also used trend analysis and professional judgment in developing these estimates. The specific considerations that the Company uses in estimating these amounts related to variable consideration are as follows: Distribution services fees – The Company pays distribution service fees to its wholesale distributors and mail-order specialty pharmacy. These fees are a contractually fixed percentage of WAC, and are calculated at the time of sale based on the purchase amount. The Company considers these fees to be separate from the customer’s purchase of the product, therefore, they are recorded in other current liabilities on the condensed consolidated balance sheet. Prompt pay and other discount s – The Company incentivizes its customers to pay their invoices on time through prompt pay discounts. These discounts are an industry standard practice, and the Company offers a prompt pay discount to each wholesale distributor customer. The specific prompt pay terms vary by customer and are contractually fixed. Prompt pay discounts are typically taken by the Company’s customers, so an estimate of the discount is recorded at the time of sale based on the purchase amount. Prompt pay discount estimates are recorded as contra trade accounts receivable on the condensed consolidated balance sheet. The Company may also give other discounts to its customers to incentivize purchases and promote customer loyalty. The terms of such discounts may vary by customer. These discounts reduce gross product revenue at the time the revenue is recognized. Chargebacks – Certain government entities and covered entities (e.g. Veterans Administration, 340B covered entities) are able to purchase the product at a price discounted below WAC. The difference between the government or covered entity purchase price and the wholesale distributor purchase price of WAC will be charged back to the Company. The Company estimates the amount of each chargeback channel based on the expected number of claims in each channel and related chargeback 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 consolidated balance sheet. Rebates – The Company is subject to mandatory discount obligations under the Medicaid and Tricare programs. The rebate amounts for these programs are determined by statutory requirements or contractual arrangements. Rebates are owed after the product has been dispensed to an end user and the Company has been invoiced. Rebates for Medicaid and Tricare are typically invoiced in arrears. The Company estimates the amount in rebates based on the expected number of claims and related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Rebate estimates are recorded as other current liabilities on the consolidated balance sheet. Patient support programs – One type of patient support program the Company offers is a co-pay program to commercially insured patients whose insurance requires a co-pay to be made when filling their prescription. This is a voluntary program that is intended to provide financial assistance to patients meeting certain eligibility requirements. The Company estimates the amount of financial assistance for these programs 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. Patient support programs estimates are recorded as other current liabilities on the consolidated balance sheet. Product returns – Customers have the right to return product that is within six months or less of the labeled expiration date or that is past the expiration date by no more than six months. Phexxi was commercially launched in September 2020 and there have been minimal returns as of June 30, 2021. The Company uses historical sales and return data to estimate future product returns. Product return estimates are recorded as other current liabilities on the consolidated balance sheet. |
Inventory | The inventory costs include all purchased materials, direct labor and manufacturing overhead. |
Convertible Notes | The Company elected the fair value option (FVO) under ASC 825, Financial Instruments (ASC 825) |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Accounting Policies [Abstract] | |
Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash, reported within the condensed consolidated statements of cash flows (in thousands): Six Months Ended June 30, 2021 2020 Cash and cash equivalents $ 46,982 $ 123,556 Restricted cash 15,206 200 Restricted cash included in other noncurrent assets 800 800 Total cash, cash equivalents and restricted cash presented in the condensed consolidated statements of cash flows $ 62,988 $ 124,556 |
Summary of Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share | Potentially dilutive securities excluded from the calculation of diluted net loss per share are summarized in the table below. Three and Six Months Ended June 30, 2021 2020 Unvested restricted common stock subject to repurchase 1,006,833 120,000 Common stock to be purchased under the 2019 ESPP 349,835 67,324 Options to purchase common stock 11,086,333 8,449,016 Warrants to purchase common stock 67,877,107 10,426,107 Total 80,320,108 19,062,447 |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | Inventories consist of the following (in thousands) for the period indicated: June 30, 2021 December 31, 2020 Raw materials $ 508 $ 332 Work in process (1) 2,675 4,162 Finished goods 7,363 2,668 Total $ 10,546 $ 7,162 _____________________ (1) The work in process balance represents all production costs incurred for partially completed goods. |
Balance Sheet Details (Tables)
Balance Sheet Details (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Prepaid and Other Current Assets | Prepaid and other current assets consist of the following (in thousands): June 30, 2021 December 31, 2020 Selling and marketing related costs $ 15,696 $ 15,414 Insurance 2,370 900 Clinical trial related costs 490 304 Subscriptions for IT platforms 258 — Manufacturing related costs 198 382 Flex note receivable (1) — 250 Other 776 800 Total $ 19,788 $ 18,050 _______________________ |
Property and Equipment, Net | Property and equipment, net, consists of the following (in thousands): Useful Life June 30, 2021 December 31, 2020 Research and production equipment 5 years $ 623 $ 623 Computer equipment and software 3 years 497 444 Office furniture 5 years 881 629 Leasehold improvements 5 years or less 3,489 1,540 Construction in-process — 2,081 2,249 7,571 5,485 Less: accumulated depreciation (1,621) (1,151) Total, net $ 5,950 $ 4,334 |
Other Noncurrent Assets | Other noncurrent assets consist of the following (in thousands): June 30, 2021 December 31, 2020 Restricted cash included in noncurrent assets $ 800 $ 800 Prepaid directors & officers' insurance 162 214 Other 59 34 Total $ 1,021 $ 1,048 |
Accrued Expenses | Accrued expenses consist of the following (in thousands): June 30, 2021 December 31, 2020 Clinical trial related costs $ 4,264 $ 1,417 Selling and marketing related costs 1,808 564 Legal and other professional fees 935 1,631 Manufacturing related costs 219 498 Other 269 366 Total $ 7,495 $ 4,476 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Values of Assets Measured on a Recurring Basis | The fair values of the Company’s assets, including the money market funds, investments in marketable fixed income debt securities classified as cash and cash equivalents, restricted cash, Flex Note receivable, and the Baker Notes, measured on a recurring basis are summarized in the following tables, as applicable (in thousands): June 30, 2021 Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs Money market funds (1) $ 60,815 $ 60,815 $ — $ — Total assets $ 60,815 $ 60,815 $ — $ — Convertible notes payable (2) $ 44,308 $ — $ — $ 44,308 Total liabilities $ 44,308 $ — $ — $ 44,308 December 31, 2020 Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs Money market funds (1) $ 53,485 $ 53,485 $ — $ — Fixed income debt securities classified as cash and cash equivalents 16,498 16,498 — — Flex note receivable 250 — 250 — Total assets $ 70,233 $ 69,983 $ 250 $ — Convertible notes payable (2) $ 50,752 $ — $ — $ 50,752 Total liabilities $ 50,752 $ — $ — $ 50,752 |
Fair Value of Liabilities Measured on Recurring Basis | The following tables summarize the changes in Level 3 financial liabilities measured at fair value on a recurring basis for the three and six months ended June 30, 2021. Baker First Closing Notes Baker Second Closing Notes Total Balance at March 31, 2021 $ 30,536 $ 20,358 $ 50,894 Change in fair value (3) (3,951) (2,635) (6,586) Balance at June 30, 2021 $ 26,585 $ 17,723 $ 44,308 Baker First Closing Notes Baker Second Closing Notes Total Balance at December 31, 2020 (2) $ 30,451 $ 20,301 $ 50,752 Change in fair value (3) (3,866) (2,578) (6,444) Balance at June 30, 2021 $ 26,585 $ 17,723 $ 44,308 _____________________ (1) Included as a component of cash and cash equivalents and restricted cash on the accompanying condensed consolidated balance sheet. (2) The convertible notes payable as of December 31, 2020 on the accompanying condensed consolidated balance sheet also includes approximately $1.7 million in accrued interest on the Baker Notes. (3) The total change in fair value on the accompanying condensed consolidated statement of operations for the three and six months ended June 30, 2021 includes approximately $2.3 million in accrued interest settled in kind. The following tables summarize the changes in Level 3 financial liabilities measured at fair value on a recurring basis for the six months ended June 30, 2020. There was no activity in the first quarter of 2020. Baker First Closing Notes Baker Second Closing Notes Baker First Closing Warrants Baker Purchase Rights Baker Second Closing Warrants Total Balance at December 31, 2019 $ — $ — $ — $ — $ — $ — Initial liability at issuance 37,405 20,715 14,007 27,636 5,098 104,861 Change in fair value (11,030) (3,132) (7,408) (11,823) (682) (34,075) Reclassification from liability to equity (6,599) — (4,416) (11,015) Exercise of Baker Purchase Rights for convertible notes — (10,715) — (10,715) Exercise of Baker Purchase Rights for warrants — (5,098) — (5,098) Balance at June 30, 2020 $ 26,375 $ 17,583 $ — $ — $ — $ 43,958 |
Fair Value Measurement Inputs | Three and Six Months Ended June 30, 2020 Expected volatility 93.7 % Risk-free interest rate 0.4 % Expected dividend yield — % Expected term (years) 4.9 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Supplemental Financial Information, Lease Cost and Other information | Three Months Ended June 30, Six Months Ended June 30, Lease Cost (in thousands) Classification 2021 2020 2021 2020 Operating lease expense Research and development $ 128 $ 105 $ 272 $ 155 Operating lease expense Selling and marketing 251 76 497 131 Operating lease expense General and administrative 205 171 408 246 Total $ 584 $ 352 $ 1,177 $ 532 Six Months Ended June 30, Other information (in thousands) 2021 2020 Cash paid for amounts included in the measurement of lease liabilities: Operating cash outflows in operating leases $ 1,139 $ 225 |
Supplemental Financial Information, Lease Assets and Liabilities and Lease Term and Discount Rate | Lease Term and Discount Rate June 30, 2021 December 31, 2020 Weighted Average Remaining Lease Term (in years) 4.00 4.43 Weighted Average Discount Rate 12 % 12 % |
Maturities of Lease Liabilities | Maturity of Operating Lease Liabilities (in thousands) June 30, 2021 Remainder of 2021 $ 1,307 Year ending December 31, 2022 2,497 Year ending December 31, 2023 2,166 Year ending December 31, 2024 2,192 Year ending December 31, 2025 1,502 Total lease payments 9,664 Less: imputed interest (2,020) Total $ 7,644 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Equity [Abstract] | |
Summary of Warrants | As of June 30, 2021, warrants to purchase up to 67,877,107 shares of the Company’s common stock remain outstanding at a weighted average exercise price of $1.54 per share. These warrants are summarized below: Type of Warrants Underlying Common Stock to be Purchased Exercise Price Issue Date Exercise Period Common Warrants 878 $ 51.24 March 30, 2012 March 30, 2012 to March 30, 2022 Common Warrants 1,171 $ 51.24 August 17, 2012 August 17, 2012 to July 17, 2022 Common Warrants 7,806 $ 3.69 June 11, 2014 June 11, 2014 to June 11, 2024 Common Warrants 848,674 $ 7.50 May 24, 2018 May 24, 2018 to May 24 2025 Common Warrants 182 $ 7.50 June 26, 2018 June 26, 2018 to June 26, 2025 Common Warrants 1,666,667 $ 6.38 April 11, 2019 October 11, 2019 to April 11, 2026 Common Warrants 2,777,779 $ 6.38 June 10, 2019 December 10, 2019 to June 10, 2026 Common Warrants 3,073,770 $ 2.44 April 24, 2020 April 24, 2020 to April 24, 2025 Common Warrants 2,049,180 $ 2.44 June 9, 2020 June 9, 2020 to June 9, 2025 Common Warrants 57,451,000 $ 1.00 May 20, 2021 May 20, 2021 to May 22, 2023 Total 67,877,107 |
Summary of Common Stock Reserved for Future Issuance | Common stock reserved for future issuance is as follows in common equivalent shares as of June 30, 2021: Common stock issuable upon the exercise of stock options outstanding 11,086,333 Common stock issuable upon the exercise of common stock warrants 67,877,107 Common stock available for future issuance under the 2019 ESPP 2,120,046 Common stock available for future issuance under the Amended and Restated 2014 Plan 1,386,769 Common stock available for future issuance under the Amended Inducement Plan 679,508 Total common stock reserved for future issuance 83,149,763 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Stock-based Compensation Expense | The following table summarizes stock-based compensation expense related to stock options, restricted stock awards (RSAs) and RSUs granted to employees, non-employee directors and consultants, and Employee Stock Purchase Plan included in the condensed consolidated statements of operations as follows (in thousands): Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Research and development $ 419 $ 916 $ 962 $ 1,398 Selling and marketing 609 1,121 1,349 1,659 General and administrative 1,965 3,997 4,146 6,378 Total $ 2,993 $ 6,034 $ 6,457 $ 9,435 |
Weighted Average Assumptions Used in Calculation of Fair Value | The fair value of noncash stock-based compensation for stock options granted to employees and non-employees was estimated on the date of grant using the Black-Scholes option pricing model based on the following weighted-average assumptions for options granted for the periods indicated. Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Expected volatility 104.1 % 80.7 % 101.1 % 80.1 % Risk-free interest rate 1.0 % 0.4 % 0.7 % 0.6 % Expected dividend yield — % — % — % — % Expected term (years) 5.5 5.9 5.9 5.9 Three and Six Months Ended June 30, 2021 2020 Expected volatility 106.9 % 108.9 % Risk-free interest rate 0.1 % 0.2 % Expected dividend yield — % — % Expected term (years) 0.5 0.5 |
Description of Business and B_2
Description of Business and Basis of Presentation - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 6 Months Ended | 9 Months Ended | 12 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2020 | |
Entity Information [Line Items] | |||||
Consideration received | $ 81,500 | ||||
Proceeds from issuance of common stock | $ 103,700 | 81,533 | $ 103,738 | ||
Proceeds from issuance of common stock, net of commissions - ATM transactions | 0 | $ 3,781 | |||
Cash, cash equivalents, and short-term investments | 47,000 | ||||
Restricted cash | 14,900 | ||||
Working capital | 27,300 | ||||
Accumulated deficit | $ 735,065 | $ 655,488 | $ 655,488 | ||
Public Offering | |||||
Entity Information [Line Items] | |||||
Proceeds from issuance of common stock, net of commissions - ATM transactions | $ 3,800 | ||||
Senior Convertible Notes Payable | |||||
Entity Information [Line Items] | |||||
Proceeds from issuance of long-term convertible notes | $ 50,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
Jun. 30, 2021USD ($) | Dec. 31, 2020USD ($) | Jun. 30, 2021USD ($)Segment | Dec. 31, 2020USD ($) | Jun. 30, 2020USD ($) | Apr. 14, 2020USD ($) | Oct. 03, 2019USD ($) | |
Concentration Risk [Line Items] | |||||||
Number of operating segments | Segment | 1 | ||||||
Restricted cash | $ 15,206,000 | $ 22,559,000 | $ 15,206,000 | $ 22,559,000 | $ 200,000 | ||
Proceeds received from issuance of convertible unsecured promissory notes | 25,000,000 | ||||||
Senior Convertible Notes Payable | |||||||
Concentration Risk [Line Items] | |||||||
Restricted cash | $ 14,900,000 | $ 14,900,000 | |||||
Letter of Credit | |||||||
Concentration Risk [Line Items] | |||||||
Letters of credit | $ 50,000 | $ 750,000 | |||||
Letter of Credit | Office space | |||||||
Concentration Risk [Line Items] | |||||||
Letters of credit | 800,000 | 800,000 | |||||
Letter of Credit | Vehicles | |||||||
Concentration Risk [Line Items] | |||||||
Letters of credit | $ 300,000 | $ 300,000 | |||||
Revenue Benchmark | Customer Concentration Risk | Three Largest Customers | |||||||
Concentration Risk [Line Items] | |||||||
Concentration risk | 83.00% | 85.00% | |||||
Accounts Receivable | Customer Concentration Risk | Three Largest Customers | |||||||
Concentration Risk [Line Items] | |||||||
Concentration risk | 85.00% | 95.00% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 | Jun. 30, 2020 | Dec. 31, 2019 |
Cash and Cash Equivalents [Line Items] | ||||
Cash and cash equivalents | $ 46,982 | $ 48,892 | $ 123,556 | |
Restricted cash | 15,206 | 22,559 | 200 | |
Restricted cash included in other noncurrent assets | 800 | 800 | ||
Total cash, cash equivalents and restricted cash presented in the condensed consolidated statements of cash flows | 62,988 | $ 72,251 | 124,556 | $ 16,625 |
Other Noncurrent Assets | ||||
Cash and Cash Equivalents [Line Items] | ||||
Restricted cash included in other noncurrent assets | $ 800 | $ 800 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Summary of Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total (in shares) | 80,320,108 | 19,062,447 | 80,320,108 | 19,062,447 |
Unvested restricted common stock subject to repurchase | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total (in shares) | 1,006,833 | 120,000 | 1,006,833 | 120,000 |
Common stock to be purchased under the 2019 ESPP | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total (in shares) | 349,835 | 67,324 | 349,835 | 67,324 |
Options to purchase common stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total (in shares) | 11,086,333 | 8,449,016 | 11,086,333 | 8,449,016 |
Warrants to purchase common stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total (in shares) | 67,877,107 | 10,426,107 | 67,877,107 | 10,426,107 |
Revenue (Details)
Revenue (Details) $ in Millions | Jun. 30, 2021USD ($) |
Revenue from Contract with Customer [Abstract] | |
Accrued balance of variable considerations | $ 2.1 |
Inventories - Schedule of Inven
Inventories - Schedule of Inventories (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 508 | $ 332 |
Work in process | 2,675 | 4,162 |
Finished goods | 7,363 | 2,668 |
Total | $ 10,546 | $ 7,162 |
Convertible Notes (Details)
Convertible Notes (Details) - USD ($) | Oct. 14, 2020 | Jun. 18, 2020 | Jun. 09, 2020 | Jun. 05, 2020 | Apr. 24, 2020 | Apr. 23, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | Apr. 25, 2020 | Jan. 17, 2018 |
Debt Instrument [Line Items] | |||||||||||||
Securities sold under purchase agreement | $ 10,000,000 | $ 15,000,000 | |||||||||||
Purchase agreement, amount of securities purchasable under agreement (up to) | $ 10,000,000 | ||||||||||||
Purchase agreement, threshold amount of aggregate gross proceeds from one or more future sales of equity securities (at least) | $ 100,000,000 | ||||||||||||
Stock option warrant to purchase, exercise price per share (in dollars per share) | $ 1.54 | $ 2.44 | $ 1.54 | $ 2.44 | |||||||||
Term | 5 years | ||||||||||||
Interest expense | $ 1,647,000 | $ 344,000 | |||||||||||
Convertible notes | 58,100,000 | ||||||||||||
Warrants and purchase rights issued | 46,700,000 | ||||||||||||
Loss on issuance of financial instruments | $ 64,000,000 | $ 0 | $ 64,049,000 | 0 | 64,049,000 | ||||||||
Gain (loss) on fair value changes | 8,910,000 | $ 34,075,000 | 8,768,000 | $ 34,075,000 | |||||||||
Reclassification of purchase rights liability | $ 15,800,000 | ||||||||||||
Reclassification from warrants liability to additional paid-in capital | $ 11,000,000 | ||||||||||||
Convertible notes payable (Note 5) | $ 44,308,000 | $ 44,308,000 | $ 52,409,000 | ||||||||||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||||||
Restricted cash | $ 14,900,000 | $ 14,900,000 | |||||||||||
Convertible notes, long-term | 26,192,000 | 26,192,000 | $ 25,211,000 | ||||||||||
Baker Bros. Notes | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Convertible notes payable (Note 5) | 44,300,000 | 44,300,000 | |||||||||||
First Closing Warrants | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Stock option warrants to purchase common stock (in shares) | 3,073,770 | ||||||||||||
Second Closing Warrants | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Stock option warrants to purchase common stock (in shares) | 2,049,180 | ||||||||||||
Senior Convertible Notes Payable | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Interest expense | 700,000 | 1,400,000 | $ 1,700,000 | ||||||||||
Senior Convertible Notes Payable | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Aggregate principal amount of convertible senior secured promissory notes (up to) | $ 25,000,000 | ||||||||||||
Note term | 5 years | ||||||||||||
Note interest rate (percent) | 10.00% | ||||||||||||
Conversion price (in dollars per share) | $ 2.44 | ||||||||||||
Written notice period | 10 days | ||||||||||||
Measurement period for determining weighted average price | 30 days | ||||||||||||
Convertible notes, stock price, benchmark (in dollars per share) | $ 4.99 | ||||||||||||
Debt redemption in event of default, multiple of outstanding balance | 3 | ||||||||||||
Senior Convertible Notes Payable | Adjuvant Notes | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Aggregate principal amount of convertible senior secured promissory notes (up to) | $ 25,000,000 | ||||||||||||
Note term | 5 years | ||||||||||||
Note interest rate (percent) | 7.50% | ||||||||||||
Interest expense | 500,000 | 1,000,000 | |||||||||||
Conversion price (in dollars per share) | $ 3.65 | ||||||||||||
Common stock, par value (in dollars per share) | $ 0.0001 | ||||||||||||
Weighted average period | 30 days | ||||||||||||
Weighted average price per share (in dollars per share) | $ 10 | ||||||||||||
Debt covenant, cumulative net sales requirement | $ 100,000,000 | ||||||||||||
Restricted cash | $ 25,000,000 | 14,900,000 | 14,900,000 | ||||||||||
Convertible notes, long-term | 26,200,000 | 26,200,000 | |||||||||||
Convertible notes, long-term, principal amount | 24,800,000 | 24,800,000 | |||||||||||
Convertible notes, long-term, accrued interest | $ 1,400,000 | $ 1,400,000 | |||||||||||
Senior Convertible Notes Payable | Adjuvant Notes | Minimum | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Beneficial ownership limitation (in percent) | 0.0499 | ||||||||||||
Senior Convertible Notes Payable | Adjuvant Notes | Maximum | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Beneficial ownership limitation (in percent) | 0.1999 | ||||||||||||
Senior Convertible Notes Payable | Period Two | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Redemption price (percent) | 100.00% | ||||||||||||
Senior Convertible Notes Payable | Period One | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Redemption price (percent) | 110.00% | ||||||||||||
Senior Convertible Notes Payable | Period Three | |||||||||||||
Debt Instrument [Line Items] | |||||||||||||
Redemption price (percent) | 110.00% |
Balance Sheet Details - Prepaid
Balance Sheet Details - Prepaid and Other Current Assets (Details) - USD ($) $ in Thousands | Jul. 31, 2016 | Jun. 30, 2021 | Dec. 31, 2020 |
Prepaid Expenses And Other Current Assets [Line Items] | |||
Prepaid and other current assets | $ 19,788 | $ 18,050 | |
Consideration transferred | $ 1,900 | ||
Cash received | 600 | ||
Payable due in consideration | $ 1,300 | ||
Interest rate (percent) | 5.00% | ||
Annual principal payment | $ 300 | ||
Selling and marketing related costs | |||
Prepaid Expenses And Other Current Assets [Line Items] | |||
Prepaid and other current assets | 15,696 | 15,414 | |
Insurance | |||
Prepaid Expenses And Other Current Assets [Line Items] | |||
Prepaid and other current assets | 2,370 | 900 | |
Clinical trial related costs | |||
Prepaid Expenses And Other Current Assets [Line Items] | |||
Prepaid and other current assets | 490 | 304 | |
Subscriptions for IT platforms | |||
Prepaid Expenses And Other Current Assets [Line Items] | |||
Prepaid and other current assets | 258 | 0 | |
Manufacturing related costs | |||
Prepaid Expenses And Other Current Assets [Line Items] | |||
Prepaid and other current assets | 198 | 382 | |
Flex note receivable | |||
Prepaid Expenses And Other Current Assets [Line Items] | |||
Prepaid and other current assets | 0 | 250 | |
Other | |||
Prepaid Expenses And Other Current Assets [Line Items] | |||
Prepaid and other current assets | $ 776 | $ 800 |
Balance Sheet Details - Propert
Balance Sheet Details - Property and Equipment, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, gross | $ 7,571 | $ 7,571 | $ 5,485 | ||
Less: accumulated depreciation | (1,621) | (1,621) | (1,151) | ||
Total, net | 5,950 | 5,950 | 4,334 | ||
Depreciation expense | 300 | $ 100 | $ 500 | $ 100 | |
Research and production equipment | |||||
Property, Plant and Equipment [Line Items] | |||||
Useful Life | 5 years | ||||
Property and equipment, gross | 623 | $ 623 | 623 | ||
Computer equipment and software | |||||
Property, Plant and Equipment [Line Items] | |||||
Useful Life | 3 years | ||||
Property and equipment, gross | 497 | $ 497 | 444 | ||
Office furniture | |||||
Property, Plant and Equipment [Line Items] | |||||
Useful Life | 5 years | ||||
Property and equipment, gross | 881 | $ 881 | 629 | ||
Leasehold improvements | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, gross | 3,489 | 3,489 | 1,540 | ||
Construction in-process | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, gross | $ 2,081 | $ 2,081 | $ 2,249 | ||
Maximum | Leasehold improvements | |||||
Property, Plant and Equipment [Line Items] | |||||
Useful Life | 5 years |
Balance Sheet Details - Other N
Balance Sheet Details - Other Non Current Assets (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Restricted cash included in noncurrent assets | $ 800 | $ 800 |
Prepaid directors & officers' insurance | 162 | 214 |
Other | 59 | 34 |
Other noncurrent assets | $ 1,021 | $ 1,048 |
Balance Sheet Details - Accrued
Balance Sheet Details - Accrued Expenses (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Clinical trial related costs | $ 4,264 | $ 1,417 |
Selling and marketing related costs | 1,808 | 564 |
Legal and other professional fees | 935 | 1,631 |
Manufacturing related costs | 219 | 498 |
Other | 269 | 366 |
Total | $ 7,495 | $ 4,476 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Fair Values of Assets Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total assets | $ 60,815 | $ 70,233 |
Convertible notes payable | 50,752 | |
Total liabilities | 44,308 | 50,752 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total assets | 60,815 | 69,983 |
Convertible notes payable | 0 | 0 |
Total liabilities | 0 | 0 |
Significant Other Observable Inputs (Level 2) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total assets | 0 | 250 |
Convertible notes payable | 0 | 0 |
Total liabilities | 0 | 0 |
Significant Unobservable Inputs (Level 3) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total assets | 0 | 0 |
Convertible notes payable | 44,308 | 50,752 |
Total liabilities | 44,308 | 50,752 |
Money market funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total assets | 60,815 | 53,485 |
Money market funds | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total assets | 60,815 | 53,485 |
Money market funds | Significant Other Observable Inputs (Level 2) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total assets | 0 | 0 |
Money market funds | Significant Unobservable Inputs (Level 3) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total assets | $ 0 | 0 |
Flex note receivable | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total assets | 250 | |
Flex note receivable | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total assets | 0 | |
Flex note receivable | Significant Other Observable Inputs (Level 2) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total assets | 250 | |
Flex note receivable | Significant Unobservable Inputs (Level 3) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total assets | 0 | |
Cash and cash equivalents | Fixed income debt securities classified as cash and cash equivalents | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total assets | 16,498 | |
Cash and cash equivalents | Quoted Prices in Active Markets for Identical Assets (Level 1) | Fixed income debt securities classified as cash and cash equivalents | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total assets | 16,498 | |
Cash and cash equivalents | Significant Other Observable Inputs (Level 2) | Fixed income debt securities classified as cash and cash equivalents | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total assets | 0 | |
Cash and cash equivalents | Significant Unobservable Inputs (Level 3) | Fixed income debt securities classified as cash and cash equivalents | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total assets | $ 0 |
Fair Value of Financial Instr_4
Fair Value of Financial Instruments - Summary of Changes in Level 3 Financial Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | ||||
Noncash interest expenses | $ 1,647 | $ 344 | ||
Accrued interest settled in kind | $ 2,300 | 2,300 | ||
Senior Convertible Notes Payable | ||||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | ||||
Noncash interest expenses | 700 | 1,400 | $ 1,700 | |
Significant Unobservable Inputs (Level 3) | Debt, Warrants, And Purchase Rights Liability | ||||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | ||||
Beginning balance | 0 | 0 | ||
Initial liability at issuance | 104,861 | |||
Change in fair value | (34,075) | |||
Reclassification from liability to equity | (11,015) | |||
Exercise of Baker Purchase Rights for convertible notes | (10,715) | |||
Exercise of Baker Purchase Rights for warrants | (5,098) | |||
Ending balance | 43,958 | |||
Significant Unobservable Inputs (Level 3) | Debt | ||||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | ||||
Beginning balance | 50,894 | 50,752 | ||
Change in fair value | (6,586) | (6,444) | ||
Ending balance | 44,308 | 44,308 | 50,752 | |
Significant Unobservable Inputs (Level 3) | Warrants | Baker First Closing Warrants | ||||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | ||||
Beginning balance | 0 | 0 | ||
Initial liability at issuance | 14,007 | |||
Change in fair value | (7,408) | |||
Reclassification from liability to equity | (6,599) | |||
Exercise of Baker Purchase Rights for convertible notes | 0 | |||
Exercise of Baker Purchase Rights for warrants | 0 | |||
Ending balance | 0 | |||
Significant Unobservable Inputs (Level 3) | Warrants | Baker Second Closing Warrants | ||||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | ||||
Beginning balance | 0 | 0 | ||
Initial liability at issuance | 5,098 | |||
Change in fair value | (682) | |||
Reclassification from liability to equity | (4,416) | |||
Exercise of Baker Purchase Rights for convertible notes | 0 | |||
Exercise of Baker Purchase Rights for warrants | 0 | |||
Ending balance | 0 | |||
Significant Unobservable Inputs (Level 3) | Purchase Rights Liability | Baker Purchase Rights | ||||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | ||||
Beginning balance | 0 | 0 | ||
Initial liability at issuance | 27,636 | |||
Change in fair value | (11,823) | |||
Reclassification from liability to equity | 0 | |||
Exercise of Baker Purchase Rights for convertible notes | (10,715) | |||
Exercise of Baker Purchase Rights for warrants | (5,098) | |||
Ending balance | 0 | |||
Baker First Closing Notes | Significant Unobservable Inputs (Level 3) | Debt | ||||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | ||||
Beginning balance | 30,536 | 30,451 | 0 | 0 |
Initial liability at issuance | 37,405 | |||
Change in fair value | (3,951) | (3,866) | (11,030) | |
Ending balance | 26,585 | 26,585 | 26,375 | 30,451 |
Baker Second Closing Notes | Significant Unobservable Inputs (Level 3) | Debt | ||||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Roll Forward] | ||||
Beginning balance | 20,358 | 20,301 | 0 | 0 |
Initial liability at issuance | 20,715 | |||
Change in fair value | (2,635) | (2,578) | (3,132) | |
Ending balance | $ 17,723 | $ 17,723 | $ 17,583 | $ 20,301 |
Fair Value of Financial Instr_5
Fair Value of Financial Instruments - First Closing Warrants (Details) - Baker First Closing Warrants | Jun. 30, 2020 |
Expected volatility | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Measurement input | 0.937 |
Risk-free interest rate | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Measurement input | 0.004 |
Expected dividend yield | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Measurement input | 0 |
Expected term (years) | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | |
Measurement input | 4.9 |
Fair Value of Financial Instr_6
Fair Value of Financial Instruments - Additional Information (Details) - USD ($) | Jun. 30, 2021 | Apr. 23, 2020 |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Purchase agreement, amount of securities purchasable under agreement (up to) | $ 10,000,000 | |
Baker Warrants | ||
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | ||
Number of shares to purchase capital stock (in shares) | 2,049,180 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) | Jan. 01, 2021USD ($) | Jun. 30, 2021USD ($)claim | Jun. 30, 2021USD ($)vehicleclaim | Dec. 31, 2020USD ($)claim | Jun. 30, 2020USD ($) | Apr. 14, 2020USD ($)ft² | Dec. 31, 2019 | Oct. 03, 2019USD ($)ft² |
Loss Contingencies [Line Items] | ||||||||
Number of vehicles delivered | vehicle | 74 | |||||||
Restricted cash | $ 15,206,000 | $ 15,206,000 | $ 22,559,000 | $ 200,000 | ||||
Office area (in square feet) | ft² | 8,816 | 24,474 | ||||||
Renewal period | 5 years | |||||||
Claims | claim | 0 | 0 | 0 | |||||
Rush University | Maximum | ||||||||
Loss Contingencies [Line Items] | ||||||||
Earned royalty threshold | $ 100,000 | |||||||
Rush University | Royalty Agreement Terms | ||||||||
Loss Contingencies [Line Items] | ||||||||
Minimum annual royalty amount | $ 100,000 | |||||||
Royalty payments | $ 100,000 | $ 100,000 | ||||||
Lease Contract Term One | ||||||||
Loss Contingencies [Line Items] | ||||||||
Lease term | 24 months | |||||||
Lease Contract Term Two | ||||||||
Loss Contingencies [Line Items] | ||||||||
Lease term | 36 months | |||||||
Vehicles | Securities Deposit | ||||||||
Loss Contingencies [Line Items] | ||||||||
Restricted cash | 300,000 | 300,000 | $ 300,000 | |||||
Office space | Securities Deposit | ||||||||
Loss Contingencies [Line Items] | ||||||||
Restricted cash | 800,000 | 800,000 | $ 800,000 | |||||
Letter of Credit | ||||||||
Loss Contingencies [Line Items] | ||||||||
Security deposit | $ 50,000 | $ 750,000 | ||||||
Letter of Credit | Vehicles | ||||||||
Loss Contingencies [Line Items] | ||||||||
Security deposit | 300,000 | 300,000 | ||||||
Letter of Credit | Office space | ||||||||
Loss Contingencies [Line Items] | ||||||||
Security deposit | $ 800,000 | $ 800,000 |
Commitments and Contingencies_2
Commitments and Contingencies - Supplemental Financial Statement Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Lessee, Lease, Description [Line Items] | |||||
Operating lease expense | $ 584 | $ 352 | $ 1,177 | $ 532 | |
Weighted Average Remaining Lease Term (in years) | 4 years | 4 years | 4 years 5 months 4 days | ||
Weighted Average Discount Rate (percent) | 12.00% | 12.00% | 12.00% | ||
Research and development | |||||
Lessee, Lease, Description [Line Items] | |||||
Operating lease expense | $ 128 | 105 | $ 272 | 155 | |
Selling and marketing | |||||
Lessee, Lease, Description [Line Items] | |||||
Operating lease expense | 251 | 76 | 497 | 131 | |
General and administrative | |||||
Lessee, Lease, Description [Line Items] | |||||
Operating lease expense | $ 205 | $ 171 | $ 408 | $ 246 |
Commitments and Contingencies_3
Commitments and Contingencies - Future Operating Lease Maturities (Details) $ in Thousands | Jun. 30, 2021USD ($) |
Maturity of Operating Lease Liabilities | |
Remainder of 2021 | $ 1,307 |
Year ending December 31, 2022 | 2,497 |
Year ending December 31, 2023 | 2,166 |
Year ending December 31, 2024 | 2,192 |
Year ending December 31, 2025 | 1,502 |
Total lease payments | 9,664 |
Less: imputed interest | (2,020) |
Total | $ 7,644 |
Commitments and Contingencies_4
Commitments and Contingencies - Supplemental Cash Flow Information (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating cash outflows in operating leases | $ 1,139 | $ 225 |
Related-party Transactions (Det
Related-party Transactions (Details) - USD ($) $ in Millions | Apr. 01, 2019 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 |
Related Party Transaction [Line Items] | |||||
Potential bonus as a percent of consulting fees earned (percent) | 100.00% | ||||
Chairman | Restricted Stock Units (RSUs) | Amended and Restated 2014 Plan | |||||
Related Party Transaction [Line Items] | |||||
Vesting period | 1 year | ||||
Issued RSU for the right to shares common stock (in shares) | 150,000 | ||||
Thomas Lynch | Consulting Agreement 2019 | |||||
Related Party Transaction [Line Items] | |||||
Vesting period | 2 years | ||||
Compensation relates management service | $ 0.4 | ||||
Thomas Lynch | Consulting Agreement 2019 | Board service | |||||
Related Party Transaction [Line Items] | |||||
Compensation relates management service | $ 0.1 | ||||
Thomas Lynch | Consulting Agreements | |||||
Related Party Transaction [Line Items] | |||||
Compensation paid | $ 0 | $ 0 | $ 0 | $ 0.1 |
Stockholders' Equity (Deficit_2
Stockholders' Equity (Deficit) - Additional Information (Details) - USD ($) | May 21, 2021 | May 20, 2021 | Apr. 06, 2021 | Mar. 29, 2021 | Jun. 10, 2020 | Jun. 05, 2020 | Jul. 31, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | May 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Nov. 30, 2019 | Jan. 17, 2018 |
Class Of Stock [Line Items] | ||||||||||||||||
Stock option warrant to purchase, exercise price per share (in dollars per share) | $ 1.54 | $ 2.44 | $ 1.54 | $ 2.44 | ||||||||||||
Common stock, shares authorized (in shares) | 300,000,000 | 300,000,000 | 300,000,000 | 300,000,000 | ||||||||||||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||||||
Consideration received | $ 81,500,000 | |||||||||||||||
Proceeds from issuance of common stock and warrants, net of discounts, fees and commissions - Public Offerings | $ 103,700,000 | $ 81,533,000 | $ 103,738,000 | |||||||||||||
Public Offering | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Number of shares issued (in shares) | 28,500,000 | |||||||||||||||
Price per share (in dollars per share) | $ 3.50 | |||||||||||||||
Consideration received | $ 93,200,000 | |||||||||||||||
Period that additional shares are available to be purchased by underwriters | 30 days | |||||||||||||||
Additional shares available for underwriters to purchase (in shares) | 4,275,000 | |||||||||||||||
Over-allotment option | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Common Warrants issued in connection with public offering (in shares) | 7,500,000 | |||||||||||||||
Stock option warrant to purchase, exercise price per share (in dollars per share) | $ 0.01 | |||||||||||||||
Number of shares issued (in shares) | 2,547,794 | 3,200,000 | ||||||||||||||
Price per share (in dollars per share) | $ 0.99 | |||||||||||||||
Consideration received | $ 2,400,000 | $ 4,200,000 | $ 10,500,000 | |||||||||||||
Period that additional shares are available to be purchased by underwriters | 30 days | |||||||||||||||
Additional shares available for underwriters to purchase (in shares) | 7,500,000 | |||||||||||||||
Proceeds from issuance of common stock - exercise of warrants | $ 100,000 | |||||||||||||||
March 2021 Public Offering | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Number of shares issued (in shares) | 17,142,857 | |||||||||||||||
Price per share (in dollars per share) | $ 1.75 | |||||||||||||||
Consideration received | $ 28,000,000 | |||||||||||||||
Period that additional shares are available to be purchased by underwriters | 30 days | |||||||||||||||
Additional shares available for underwriters to purchase (in shares) | 2,571,428 | |||||||||||||||
Proceeds from issuance of common stock - exercise of warrants | $ 46,800,000 | |||||||||||||||
May 2021 Public Offering | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Common Warrants issued in connection with public offering (in shares) | 50,000,000 | |||||||||||||||
Stock option warrant to purchase, exercise price per share (in dollars per share) | $ 1 | |||||||||||||||
Number of shares issued (in shares) | 50,000,000 | |||||||||||||||
Price per share (in dollars per share) | $ 1 | |||||||||||||||
At The Market (ATM) | Piper Sandler Co. | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Number of shares issued (in shares) | 676,656 | |||||||||||||||
Offering price of shares (up to) | $ 50,000,000 | |||||||||||||||
Proceeds from issuance of common stock and warrants, net of discounts, fees and commissions - Public Offerings | $ 3,800,000 | |||||||||||||||
Other receivables | $ 300,000 | |||||||||||||||
Preferred Stock | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Issuance and sale of an aggregate shares (in shares) | 5,000,000 | |||||||||||||||
Preferred stock par value (in dollars per share) | $ 0.0001 | |||||||||||||||
Security Purchase Agreement Warrants | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Common Warrants issued in connection with public offering (in shares) | 5,122,950 | 5,122,950 | ||||||||||||||
Stock option warrant to purchase, exercise price per share (in dollars per share) | $ 2.44 | $ 2.44 | ||||||||||||||
Warrants | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Issuance of common stock (in shares) | 49,000 | |||||||||||||||
Warrants | Subsequent Event | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Issuance of common stock (in shares) | 110,000 | |||||||||||||||
Warrants | Public Offering | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Common Warrants issued in connection with public offering (in shares) | 57,500,000 | |||||||||||||||
Stock option warrant to purchase, exercise price per share (in dollars per share) | $ 1 |
Stockholders' Equity (Deficit_3
Stockholders' Equity (Deficit) - Summary of Warrants (Details) - $ / shares | Jun. 30, 2021 | May 20, 2021 | Jun. 30, 2020 | Jun. 09, 2020 | Apr. 24, 2020 | Jun. 10, 2019 | Apr. 11, 2019 | Jun. 26, 2018 | May 24, 2018 | Jun. 11, 2014 | Aug. 17, 2012 | Mar. 30, 2012 |
Class of Warrant or Right [Line Items] | ||||||||||||
Underlying Common Stock to be Purchased (in shares) | 67,877,107 | |||||||||||
Exercise Price (in dollars per share) | $ 1.54 | $ 2.44 | ||||||||||
Common Warrants | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Underlying Common Stock to be Purchased (in shares) | 57,451,000 | 2,049,180 | 3,073,770 | 2,777,779 | 1,666,667 | 182 | 848,674 | 7,806 | 1,171 | 878 | ||
Exercise Price (in dollars per share) | $ 1 | $ 2.44 | $ 2.44 | $ 6.38 | $ 6.38 | $ 7.50 | $ 7.50 | $ 3.69 | $ 51.24 | $ 51.24 |
Stockholders' Equity (Deficit_4
Stockholders' Equity (Deficit) - Summary of Common Stock Reserved for Future Issuance (Details) - shares | Jun. 30, 2021 | Jan. 01, 2021 |
Class Of Stock [Line Items] | ||
Common stock issuable upon the exercise of common stock warrants (in shares) | 67,877,107 | |
Total common stock reserved for future issuance (in shares) | 83,149,763 | |
Employee Stock Purchase Plan 2019 | ||
Class Of Stock [Line Items] | ||
Common stock available for future issuance under 2019 ESPP (in shares) | 2,120,046 | 1,000,000 |
Amended and Restated 2014 Plan | ||
Class Of Stock [Line Items] | ||
Common stock available for future issuance under the Amended and Restated 2014 Plan and Inducement Plan (in shares) | 1,386,769 | |
Inducement Plan | ||
Class Of Stock [Line Items] | ||
Common stock available for future issuance under the Amended and Restated 2014 Plan and Inducement Plan (in shares) | 679,508 | |
Options to Purchase Common Stock | ||
Class Of Stock [Line Items] | ||
Common stock issuable upon the exercise of stock options outstanding (in shares) | 11,086,333 |
Stock-based Compensation - Summ
Stock-based Compensation - Summary of Stock-based Compensation Expense Related to Stock Options, Restricted Stock Awards (RSAs) and RSUs Granted to Employees and Non-employee Directors (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total | $ 2,993 | $ 6,034 | $ 6,457 | $ 9,435 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total | 419 | 916 | 962 | 1,398 |
Selling and marketing | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total | 609 | 1,121 | 1,349 | 1,659 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total | $ 1,965 | $ 3,997 | $ 4,146 | $ 6,378 |
Stock-based Compensation - Addi
Stock-based Compensation - Additional Information (Details) - USD ($) | May 07, 2019 | Feb. 26, 2019 | Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Jan. 01, 2021 | Feb. 25, 2020 | Jul. 24, 2018 | Sep. 15, 2014 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Options granted (in shares) | 578,500 | 767,000 | 3,056,525 | 2,242,485 | |||||||
Share-based compensation expense | $ 2,993,000 | $ 6,034,000 | $ 6,457,000 | $ 9,435,000 | |||||||
Stock options | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Unrecognized stock-based compensation expense | 11,100,000 | $ 11,100,000 | |||||||||
Recognition period for unrecognized share-based compensation expense | 2 years 7 months 6 days | ||||||||||
Restricted Stock Awards and Restricted Stock Units | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Share-based compensation expense | 1,300,000 | $ 4,400,000 | $ 2,900,000 | $ 6,400,000 | |||||||
2012 Equity Incentive Plan | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Expiration period | 10 years | ||||||||||
2012 Equity Incentive Plan | Vesting period one | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Vesting period | 4 years | ||||||||||
Percent exercisable | 25.00% | ||||||||||
2012 Equity Incentive Plan | Vesting period two | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Vesting period | 3 years | ||||||||||
Percent exercisable | 25.00% | ||||||||||
Amended and Restated 2014 Plan | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Number of shares authorized (in shares) | 7,800,000 | 11,725,515 | 749,305 | ||||||||
Automatic shares authorized under plan increase, percentage of common stock issued and outstanding (percent) | 4.00% | ||||||||||
Incremental number of shares authorized (in shares) | 3,254,061 | 2,000,000 | |||||||||
Amended and Restated 2014 Plan | Restricted Stock Awards (RSA) | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Unrecognized stock-based compensation expense | $ 600,000 | $ 600,000 | |||||||||
Recognition period for unrecognized share-based compensation expense | 7 months 6 days | ||||||||||
Amended and Restated 2014 Plan | Restricted Stock Awards (RSA) | Executive Management Team and Certain Non-Executive Employees | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Issued for the right to shares common stock (in shares) | 5,000 | 20,000 | 1,777,500 | 1,265,000 | |||||||
Amended and Restated 2014 Plan | Vesting period one | Restricted Stock Awards (RSA) | Management | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Issued for the right to shares common stock (in shares) | 1,767,500 | ||||||||||
Inducement Plan | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Number of shares authorized (in shares) | 1,250,000 | 250,000 | |||||||||
Employee Stock Purchase Plan 2019 | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Common stock available for future issuance under 2019 ESPP (in shares) | 2,120,046 | 2,120,046 | 1,000,000 | ||||||||
Shares of common stock purchased under the ESPP (in shares) | 173,675 | 67,454 | 173,675 | 67,454 | |||||||
Employee Stock Purchase Plan 2019 | ESPP | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Automatic shares authorized under plan increase, percentage of common stock issued and outstanding (percent) | 2.00% | ||||||||||
Incremental number of shares authorized (in shares) | 1,000,000 | ||||||||||
Common stock available for future issuance under 2019 ESPP (in shares) | 500,000 | ||||||||||
Purchase price as a percentage of common stock (percent) | 85.00% | ||||||||||
Denominator in calculation of ESPP | $ 25,000 | $ 25,000 | |||||||||
Employee Stock Purchase Plan 2019 | ESPP | Minimum | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Contribution limitations, percentage of employees salaries (percent) | 1.00% | ||||||||||
Employee Stock Purchase Plan 2019 | ESPP | Maximum | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Contribution limitations, percentage of employees salaries (percent) | 15.00% |
Stock-based Compensation - Su_2
Stock-based Compensation - Summary of Assumptions (Details) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Stock options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected volatility (percent) | 104.10% | 80.70% | 101.10% | 80.10% |
Risk-free interest rate (percent) | 1.00% | 0.40% | 0.70% | 0.60% |
Expected dividend yield (percent) | 0.00% | 0.00% | 0.00% | 0.00% |
Expected term (years) | 5 years 6 months | 5 years 10 months 24 days | 5 years 10 months 24 days | 5 years 10 months 24 days |
ESPP | Employee Stock Purchase Plan 2019 | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected volatility (percent) | 106.90% | 108.90% | 106.90% | 108.90% |
Risk-free interest rate (percent) | 0.10% | 0.20% | 0.10% | 0.20% |
Expected dividend yield (percent) | 0.00% | 0.00% | 0.00% | 0.00% |
Expected term (years) | 6 months | 6 months | 6 months | 6 months |