Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2020 | Oct. 31, 2020 | |
Entity Information [Line Items] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2020 | |
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 | 81,280,286 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q3 | |
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 | Sep. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 86,697 | $ 15,571 |
Restricted cash | 337 | 304 |
Short-term investments | 0 | 8,233 |
Trade accounts receivable, net | 1,243 | 0 |
Inventories | 3,164 | 0 |
Prepaid and other current assets | 10,638 | 2,313 |
Total current assets | 102,079 | 26,421 |
Property and equipment, net | 1,976 | 394 |
Operating lease right-of-use assets | 7,198 | 160 |
Other noncurrent assets | 1,074 | 1,320 |
Total assets | 112,327 | 28,295 |
Current liabilities: | ||
Accounts payable | 5,427 | 6,008 |
Convertible notes payable | 48,055 | 0 |
Accrued expenses | 4,607 | 2,784 |
Accrued compensation | 4,954 | 3,670 |
Operating lease liabilities – current | 1,728 | 197 |
Other current liabilities | 921 | 0 |
Total current liabilities | 65,692 | 12,659 |
Operating lease liabilities – noncurrent | 6,425 | 0 |
Total liabilities | 72,117 | 12,659 |
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; 81,280,286 and 48,137,880 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively; | 8 | 5 |
Additional paid-in capital | 655,092 | 528,810 |
Accumulated deficit | (614,890) | (513,179) |
Total stockholders’ equity | 40,210 | 15,636 |
Total liabilities and stockholders’ equity | $ 112,327 | $ 28,295 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common Stock, Shares Authorized | 300,000,000 | 300,000,000 |
Common stock, shares issued (in shares) | 81,280,286 | 48,137,880 |
Common stock, shares outstanding (in shares) | 81,280,286 | 48,137,880 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares | Sep. 30, 2020 | Dec. 31, 2019 |
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) | 81,280,286 | 48,137,880 |
Common stock, shares outstanding (in shares) | 81,280,286 | 48,137,880 |
Preferred Stock | ||
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 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Income Statement [Abstract] | ||||
Product sales, net | $ 278 | $ 0 | $ 278 | $ 0 |
Operating expenses: | ||||
Cost of goods sold | 317 | 0 | 317 | 0 |
Research and development | 4,217 | 5,663 | 11,104 | 18,798 |
Selling and marketing | 14,700 | 3,791 | 32,553 | 6,222 |
General and administrative | 7,200 | 4,843 | 24,077 | 14,850 |
Total operating expenses | 26,434 | 14,297 | 68,051 | 39,870 |
Loss from operations | (26,156) | (14,297) | (67,773) | (39,870) |
Other income (expense): | ||||
Interest income | 21 | 212 | 152 | 338 |
Other (expense) income | (657) | 287 | (1,010) | 266 |
Loss on issuance of financial instruments | 0 | 0 | (64,049) | (674) |
Change in fair value of financial instruments | (3,105) | 0 | 30,971 | (27,372) |
Total other (expense) income, net | (3,741) | 499 | (33,936) | (27,442) |
Loss before income tax | (29,897) | (13,798) | (101,709) | (67,312) |
Income tax expense | (2) | 0 | (2) | (4) |
Net loss | $ (29,899) | $ (13,798) | $ (101,711) | $ (67,316) |
Net loss per share, basic and diluted (in dollars per share) | $ (0.37) | $ (0.30) | $ (1.63) | $ (1.83) |
Weighted-average shares used to compute net loss per share, basic and diluted (in shares) | 81,206,101 | 46,239,225 | 62,434,949 | 36,760,013 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT) (Unaudited) - USD ($) | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit | At The Market (ATM) | At The Market (ATM)Common Stock | At The Market (ATM)Additional Paid-in Capital | Reload Warrants | Reload WarrantsCommon Stock | Reload WarrantsAdditional Paid-in Capital | Private Placement | Private PlacementCommon Stock | Private PlacementAdditional Paid-in Capital |
Beginning balance, shares at Dec. 31, 2018 | 25,867,248 | ||||||||||||
Beginning balance at Dec. 31, 2018 | $ (23,356,000) | $ 3,000 | $ 409,787,000 | $ (433,146,000) | |||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Issuance of common stock (in shares) | 2,376,065 | ||||||||||||
Issuance of common stock upon cash exercise of warrants and issuance of Reload Warrants (see Note 11) | $ 10,617,000 | $ 10,617,000 | |||||||||||
Restricted stock awards issued/restricted stock units released (in shares) | 470,500 | ||||||||||||
Shares withheld to cover taxes related to vesting of restricted stock awards (in shares) | (1,639) | ||||||||||||
Shares withheld to cover taxes related to vesting of restricted stock awards | (6,000) | (6,000) | |||||||||||
Stock-based compensation | 1,962,000 | 1,962,000 | |||||||||||
Net loss | (18,068,000) | (18,068,000) | |||||||||||
Ending balance, shares at Mar. 31, 2019 | 28,712,174 | ||||||||||||
Ending balance at Mar. 31, 2019 | (28,851,000) | $ 3,000 | 422,360,000 | (451,214,000) | |||||||||
Beginning balance, shares at Dec. 31, 2018 | 25,867,248 | ||||||||||||
Beginning balance at Dec. 31, 2018 | (23,356,000) | $ 3,000 | 409,787,000 | (433,146,000) | |||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Net loss | (67,316,000) | ||||||||||||
Ending balance, shares at Sep. 30, 2019 | 46,791,230 | ||||||||||||
Ending balance at Sep. 30, 2019 | 24,075,000 | $ 5,000 | 524,532,000 | (500,462,000) | |||||||||
Beginning balance, shares at Mar. 31, 2019 | 28,712,174 | ||||||||||||
Beginning balance at Mar. 31, 2019 | (28,851,000) | $ 3,000 | 422,360,000 | (451,214,000) | |||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Issuance of common stock (in shares) | 17,777,779 | ||||||||||||
Issuance of common stock in connection with ATM, the Public Offering, and the Private Placement | $ 68,324,000 | $ 2,000 | $ 68,322,000 | ||||||||||
Issuance of common stock - exercise of stock options (in shares) | 16,823 | ||||||||||||
Issuance of common stock - exercise of stock options | 46,000 | 46,000 | |||||||||||
Restricted stock awards issued/restricted stock units released (in shares) | 6,000 | ||||||||||||
Shares withheld to cover taxes related to vesting of restricted stock awards (in shares) | (86,461) | ||||||||||||
Shares withheld to cover taxes related to vesting of restricted stock awards | (518,000) | (518,000) | |||||||||||
Reclassification from financial instruments liability to equity | 29,726,000 | 29,726,000 | |||||||||||
Stock-based compensation | 2,515,000 | 2,515,000 | |||||||||||
Net loss | (35,450,000) | (35,450,000) | |||||||||||
Ending balance, shares at Jun. 30, 2019 | 46,426,315 | ||||||||||||
Ending balance at Jun. 30, 2019 | 35,792,000 | $ 5,000 | 522,451,000 | (486,664,000) | |||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Financing costs in connection with the Private Placement (see Note 10) | (60,000) | (60,000) | |||||||||||
Issuance of common stock - exercise of warrants (in shares) | 200,064 | ||||||||||||
Restricted stock awards issued/restricted stock units released (in shares) | 189,000 | ||||||||||||
Shares withheld to cover taxes related to vesting of restricted stock awards (in shares) | 24,149 | ||||||||||||
Shares withheld to cover taxes related to vesting of restricted stock awards | (122,000) | (122,000) | |||||||||||
Stock-based compensation | 2,263,000 | 2,263,000 | |||||||||||
Net loss | (13,798,000) | (13,798,000) | |||||||||||
Ending balance, shares at Sep. 30, 2019 | 46,791,230 | ||||||||||||
Ending balance at Sep. 30, 2019 | 24,075,000 | $ 5,000 | 524,532,000 | (500,462,000) | |||||||||
Beginning balance, shares at Dec. 31, 2019 | 48,137,880 | ||||||||||||
Beginning balance at Dec. 31, 2019 | 15,636,000 | $ 5,000 | 528,810,000 | (513,179,000) | |||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Issuance of common stock (in shares) | 202,098 | ||||||||||||
Issuance of common stock in connection with ATM, the Public Offering, and the Private Placement | $ 1,082,000 | $ 1,082,000 | |||||||||||
Issuance of common stock - exercise of stock options (in shares) | 19,708 | ||||||||||||
Issuance of common stock - exercise of stock options | 73,000 | 73,000 | |||||||||||
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 | (25,000) | (25,000) | |||||||||||
Stock-based compensation | 3,401,000 | 3,401,000 | |||||||||||
Net loss | (19,146,000) | (19,146,000) | |||||||||||
Ending balance, shares at Mar. 31, 2020 | 49,642,097 | ||||||||||||
Ending balance at Mar. 31, 2020 | 1,021,000 | $ 5,000 | 533,341,000 | (532,325,000) | |||||||||
Beginning balance, shares at Dec. 31, 2019 | 48,137,880 | ||||||||||||
Beginning balance at Dec. 31, 2019 | 15,636,000 | $ 5,000 | 528,810,000 | (513,179,000) | |||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Short-swing profit disgorgement | 200,000 | ||||||||||||
Net loss | (101,711,000) | ||||||||||||
Ending balance, shares at Sep. 30, 2020 | 81,280,286 | ||||||||||||
Ending balance at Sep. 30, 2020 | 40,210,000 | $ 8,000 | 655,092,000 | (614,890,000) | |||||||||
Beginning balance, shares at Mar. 31, 2020 | 49,642,097 | ||||||||||||
Beginning balance at Mar. 31, 2020 | 1,021,000 | $ 5,000 | 533,341,000 | (532,325,000) | |||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Issuance of common stock (in shares) | 31,700,000 | 474,558 | 200 | ||||||||||
Issuance of common stock in connection with ATM, the Public Offering, and the Private Placement | 103,266,000 | $ 3,000 | 103,263,000 | $ 2,280,000 | $ 2,280,000 | ||||||||
Issuance of common stock - ESPP and exercise of stock options (in shares) | 69,398 | ||||||||||||
Issuance of common stock - ESPP and exercise of stock options | 177,000 | 177,000 | |||||||||||
Restricted stock awards issued/restricted stock units released (in shares) | 60,168 | ||||||||||||
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 | (2,777,000) | (2,777,000) | |||||||||||
Stock-based compensation | 6,034,000 | 6,034,000 | $ 2,000 | $ 2,000 | |||||||||
Short-swing profit disgorgement | 187,000 | 187,000 | |||||||||||
Reclassification from financial instruments liability to equity | 11,015,000 | 11,015,000 | |||||||||||
Net loss | (52,666,000) | (52,666,000) | |||||||||||
Ending balance, shares at Jun. 30, 2020 | 81,300,667 | ||||||||||||
Ending balance at Jun. 30, 2020 | 68,539,000 | $ 8,000 | 653,522,000 | (584,991,000) | |||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||||||||||
Shares withheld to cover taxes related to vesting of restricted stock awards (in shares) | (20,381) | ||||||||||||
Shares withheld to cover taxes related to vesting of restricted stock awards | (67,000) | (67,000) | |||||||||||
Stock-based compensation | 1,637,000 | 1,637,000 | |||||||||||
Short-swing profit disgorgement | 0 | ||||||||||||
Net loss | (29,899,000) | (29,899,000) | |||||||||||
Ending balance, shares at Sep. 30, 2020 | 81,280,286 | ||||||||||||
Ending balance at Sep. 30, 2020 | $ 40,210,000 | $ 8,000 | $ 655,092,000 | $ (614,890,000) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (101,711) | $ (67,316) |
Adjustments to reconcile net loss to net cash, cash equivalents and restricted cash used in operating activities: | ||
Loss on issuance of financial instruments | 64,049 | 674 |
Change in fair value of financial instruments | (30,971) | 27,372 |
Stock-based compensation | 11,072 | 6,740 |
Depreciation | 181 | 198 |
Noncash lease expenses | 542 | 487 |
Noncash interest expenses | 992 | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (1,243) | 0 |
Inventories | (2,912) | 0 |
Prepaid and other assets | (9,070) | (408) |
Accounts payable | (505) | (3,628) |
Accrued expenses and other liabilities | 2,900 | (5,186) |
Accrued compensation | 1,283 | (8) |
Operating lease liabilities | (357) | (576) |
Net cash, cash equivalents and restricted cash used in operating activities | (65,750) | (41,651) |
Cash flows from investing activities: | ||
Proceeds from sale of Softcup line of business | 250 | 250 |
Maturities of short-term investments | 8,233 | 0 |
Purchase of short-term investments | 0 | (3,715) |
Purchases of property and equipment | (833) | (23) |
Net cash, cash equivalents and restricted cash provided by (used in) investing activities | 7,650 | (3,488) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock - exercise of warrants | 2 | 6,273 |
Proceeds from issuance of common stock, warrants and purchase rights in connection with the 2019 Private Placement, net of financial advisory fees | 0 | 75,400 |
Proceeds from issuance of common stock, net of discounts and commissions - Public Offering | 103,738 | 0 |
Proceeds from issuance of common stock, net of commissions - ATM transactions | 3,781 | 0 |
Proceeds from issuance of common stock - ESPP and exercise of stock options | 337 | 46 |
Borrowings under convertible notes | 25,000 | 0 |
Short-swing profit disgorgement | 187 | 0 |
Repayment of Vendor Note | 0 | (4,010) |
Cash paid for financing costs | (867) | (1,180) |
Payments for tax withholdings related to vesting of restricted stock awards | (2,869) | (645) |
Net cash, cash equivalents and restricted cash provided by financing activities | 129,309 | 75,884 |
Net change in cash, cash equivalents and restricted cash | 71,209 | 30,745 |
Cash, cash equivalents and restricted cash, beginning of period | 16,625 | 1,761 |
Cash, cash equivalents and restricted cash, end of period | 87,834 | 32,506 |
Supplemental disclosure of noncash investing and financing activities: | ||
Right-of-use assets obtained in exchange for operating lease liabilities | 7,618 | 802 |
Financing costs included in accounts payable and accrued expenses | 0 | 50 |
Purchases of property and equipment included in accounts payable and accrued expenses | 73 | 127 |
Reclassification of financial instruments liability to equity | $ 11,015 | $ 6,120 |
Description of Business and Bas
Description of Business and Basis of Presentation | 9 Months Ended |
Sep. 30, 2020 | |
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 On January 17, 2018, Neothetics, Inc., a Delaware corporation (Neothetics), now known as Evofem Biosciences, Inc. (the Company), completed its merger (the Merger) with privately-held Evofem Biosciences Operations, Inc. (Private Evofem), in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated October 17, 2017, whereby Nobelli Merger Sub, Inc., a Delaware corporation and wholly-owned subsidiary of Neothetics, merged with and into Private Evofem, with Private Evofem surviving as Neothetics’ wholly-owned subsidiary. Unless otherwise noted, references in this report to “Evofem” and the “Company” refer to Evofem Biosciences, Inc. and its subsidiaries following the closing of the Merger. 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™ (lactic acid, citric acid, and potassium bitartrate) vaginal gel, was approved by the U.S. Food and Drug Administration (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 sexually transmitted infections 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, 2019 included in its Annual Report on Form 10-K as filed with the SEC on March 12, 2020 (the 2019 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 nine months ended September 30, 2020 are not necessarily indicative of the results expected for the full year. The condensed consolidated balance sheet as of December 31, 2019 was derived from the 2019 Audited Financial Statements. Reclassification The Company has separated the presentation of selling and marketing expenses from the total general and administrative expenses in the current period condensed consolidated statement of operations. To conform prior year amounts to the current period presentation, totals of $3.8 million and $6.2 million were reclassified from general and administrative expenses to selling and marketing expenses for the three and nine months ended September 30, 2019, respectively. Risks, Uncertainties and Going Concern 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 development of Phexxi, selling and marketing related activities for preparation of the commercial launch of Phexxi, as well as raising capital, recruiting personnel and establishing a corporate infrastructure to support a commercial product. The Company has recognized limited revenues since the commercial launch of Phexxi on September 8, 2020 and, as such, has incurred operating losses and negative cash flows from operating activities since inception. As described in Note 5- Convertible Notes and Note 11- Stockholders' Equity , during the nine months ended September 30, 2020, the Company received gross proceeds of $25.0 million from the issuance of convertible notes in the second quarter of 2020, net proceeds of approximately $103.7 million upon the sale and issuance of common stock from the underwritten public offering in June 2020, and $3.8 million from its “at the market” (ATM) program, net of commissions. As of September 30, 2020, the Company had cash and cash equivalents of $86.7 million, working capital of $36.4 million and an accumulated deficit of $614.9 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. When compared to the prior year, R&D expenses are expected to decrease in 2020 due to completion of the clinical phase of AMPREVENCE, the Phase 2b clinical trial of EVO100, in December 2019, partially offset by the initiation of EVOGUARD, the Phase 3 clinical trial of EVO100 in October 2020. Additionally, selling and marketing expenses are expected to increase significantly in 2020 due to pre-commercialization activities preceding the US commercial launch of Phexxi in September 2020 and the subsequent initiation of full commercialization activities post commercial launch through the remainder of 2020 and in future periods. When compared to the prior year, the Company expects general and administrative expenses to increase in 2020 as it hires additional personnel and it engages third parties to support the growth of our business. According to management estimates, liquidity resources as of September 30, 2020 are not sufficient to maintain its planned level of operations for the 12 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. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and the notes thereto. S ignificant estimates affecting amounts reported or disclosed in the 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 (ROU) assets and lease liabilities, the assumptions used in estimating the fair value of 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. These assumptions are more fully described in Note 3- Revenue R eco gnition , Note 5- Convertible Notes , Note 7- Fair Value of Financial Instruments , Note 8- Commitments and Contingencies , and Note 12- 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 (CEO) 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 the 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. Significant Accounting Policies There have been several changes to the significant accounting policies that were described in Note 2 to the 2019 Audited Financial Statements during the third quarter of 2020. These changes include the Trade Accounts Receivable and Allowance as described below, and also the accounting policy for revenue recognition, inventories, and the Company's election of fair value option (FVO) to account for certain financial liabilities as described in Note 3- Revenue Recognition , Note 4- Inventories , and Note 5- Convertible Notes , respectively. Cash, Cash Equivalents and Restricted Cash Cash and cash equivalents consist of readily available cash in checking accounts, money market funds, and investments in fixed income debt securities with original maturities of less than three months. 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 . The following table provides a reconciliation of cash, cash equivalents and restricted cash, reported within the condensed consolidated statements of cash flows (in thousands): Nine Months Ended September 30, 2020 2019 Cash and cash equivalents $ 86,697 $ 32,120 Restricted cash 337 386 Restricted cash included in other noncurrent assets 800 — Total cash, cash equivalents and restricted cash presented in the condensed consolidated statements of cash flows $ 87,834 $ 32,506 Trade Accounts Receivable and Allowance Trade accounts receivable are amounts owed to the Company by its customers for product that has been delivered. The trade accounts receivable are recorded at the invoice amount, less prompt pay and other discounts, chargebacks, and an allowance for credit losses, if any. The allowance for credit losses is the Company’s estimate of losses over the life of the receivables. The Company evaluates forward looking economic factors and uses professional judgment to determine the allowance for credit losses, as Phexxi was commercially launched in September 2020 and historical data is not yet available. The credit loss reserves are reviewed and adjusted periodically. Trade accounts receivable are aged based on the contractual payment terms. When the collectability of an invoice is no longer probable, the Company will create a reserve for that specific receivable. If a receivable is determined to be uncollectible, it is charged against the general credit loss reserve or the reserve for the specific receivable, if one exists. 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 Nine Months Ended September 30, 2020 2019 Unvested restricted stock awards subject to repurchase 70,000 421,300 Unvested restricted stock units — 113,000 Common stock to be purchased under the 2019 ESPP 64,442 55,132 Options to purchase common stock 8,972,112 6,424,179 Warrants to purchase common stock 10,426,107 6,168,815 Total 19,532,661 13,182,426 Recently Adopted Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (FASB) issued ASU No. 2016-13, Financial Instruments - Credit Losses , removing, modifying and adding certain disclosure requirements of ASC 326, Measurement of Credit Losses on Financial Instruments (ASU No. 2016-13), which requires credit losses relating to held-to maturity debt securities should be recorded through an allowance for credit losses. ASU No. 2016-13 was effective for the Company on January 1, 2020. The adoption of this new standard did not have a material impact on the Company's condensed consolidated financial statements. In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (ASU No. 2018-13), which removes, modifies and adds certain disclosure requirements on fair value measurements in ASC 820, Fair Value Measurements and Disclosures . ASU No. 2018-13 was effective for the Company on January 1, 2020. The adoption of this new standard did not have a material impact on the Company's condensed consolidated financial statements. In August 2018, the FASB issued ASU No. 2018-15, Intangibles—Goodwill and Other removing, modifying and adding certain disclosure requirements of ASC 350, Internal-Use Software (ASU No. 2018-15), which requires capitalizing implementation costs incurred to develop or obtain internal-use software in a cloud computing arrangement that is a service contract. ASU No. 2018-15 was effective for the Company on January 1, 2020. The adoption of this new standard did not have a material impact on the Company's condensed consolidated financial statements. Recently Issued Accounting Pronouncements — Not Yet Adopted In August 2020, the FASB 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 the expected impact of ASU 2020-06 on the condensed consolidated financial statements. |
Revenue Recognition
Revenue Recognition | 9 Months Ended |
Sep. 30, 2020 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Recognition | Revenue Recognition The Company recognizes revenue from the sale of its product, 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 and a specialty retail 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 . The amount of revenue recognized by the Company is equal to the amount of consideration that is expected to be received from the sale of product to its customers. Revenue is only recognized when it is probable that a significant reversal will not occur in future periods. To determine whether a significant reversal will occur in future periods, the Company assesses both the likelihood and magnitude of any such potential reversal of revenue. Phexxi is sold to customers at the wholesale acquisition cost (WAC). However, the Company records product revenue, net of reserves for applicable variable consideration. These types of variable consideration items reduce revenue and include the following: • Distribution services fees • Prompt pay and other discounts • Product returns • Chargebacks • Rebates • Co-payment assistance An estimate for each variable consideration item is made 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 specialty pharmacy, and other relevant data reports. However, because Phexxi was launched in September 2020 this historical data is limited. The Company compensated for this lack of historical data with trend analysis, industry standard data, and professional judgment. The specific considerations that the Company uses in estimating these amounts related to variable considerations are as follows. Distribution services fees – The Company pays distribution service fees to its wholesale distributors and 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 recorded. Product returns – Customers have the right to return product that is within six months or less of the labeled expiration date or that is past the expiration date by no more than six months. Phexxi was commercially launched in September 2020 and there were no returns as of September 30, 2020. Due to the lack of historical data, the Company used professional judgment to estimate returns based on industry data for similar products. As time passes and historical data becomes available, the Company will begin to use historical sales and return data to estimate future product returns. Certain wholesale distributors also have the ability to return product that is related to the initial stocking order for the Phexxi product launch. The specific terms for this type of product return vary by the specific wholesale distributor agreement. Product return estimates and recorded as other current liabilities on the condensed consolidated balance sheet. Chargebacks – Certain government entities and covered entities (e.g. Veterans Administration, 340B covered entities) will be able to purchase the product at a price discounted below WAC. The Company is currently in the process of finalizing agreements with these types of entities. The difference between the government or covered entity purchase price and the wholesale distributor purchase price of WAC will be charged back to the Company. The Company estimates the amount in chargebacks based on the expected number of claims and related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Estimated chargebacks are recorded as contra trade accounts receivable on the condensed consolidated balance sheet. Rebates – The Company will be subject to mandatory discount obligations under the Medicaid and Tricare programs. The Company is currently in the process of finalizing these agreements with Medicaid and Tricare. The rebate amounts for these programs are determined by statutory requirements or contractual arrangements. Rebates are owed after the product has been dispensed to an end user and the Company has been invoiced. Rebates for Medicaid and Tricare are typically invoiced in arrears. The Company estimates the amount in rebates based on the expected number of claims and related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Rebate estimates are recorded as other current liabilities on the condensed consolidated balance sheet. Co-payment assistance - The Company offers a co-payment assistance program to commercially insured patients whose insurance requires a co-payment to be made when filling their prescription. This is a voluntary program that is intended to provide financial assistance to patients meeting certain eligibility requirements. The Company estimates the amount of co-payment assistance based on the expected number of claims and related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Co-payment assistance estimates are recorded as other current liabilities on the condensed consolidated balance sheet. The following table summarizes the balances and activity of product revenue variable consideration recorded as contra trade accounts receivable (in thousands): Total Balance at December 31, 2019 $ — Provision for the current period sales 123 Credit or payments made within the period (25) Balance at September 30, 2020 $ 98 The following table summarizes the balances and activity of product revenue variable consideration recorded as other current liabilities (in thousands): Total Balance at December 31, 2019 $ — Provision for the current period sales 1,015 Credit or payments made within the period (94) Balance at September 30, 2020 $ 921 |
Inventories
Inventories | 9 Months Ended |
Sep. 30, 2020 | |
Inventory Disclosure [Abstract] | |
Inventories | Inventories Inventories, consisting of purchased materials, direct labor and manufacturing overheads, are stated at the lower of cost, or net realizable value. Cost is determined on a first-in, first-out basis. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. At each balance sheet date, the Company evaluates ending inventories for excess quantities, obsolescence, or shelf-life expiration. The evaluation includes an analysis of the Company’s current and future strategic plans, anticipated future sales, the price projections of future demand, and the remaining shelf life of goods on han d. To the extent that management determines there are excess or obsolete inventory or quantities with a shelf life that is too near its expiration for the Company to reasonably expect that it can sell those products prior to their expiration, the Company adjusts the carrying value to estimated net realizable value in accordance with the first-in, first-out inventory costing method. The Company began to capitalize the inventory costs associated with Phexxi in April 2020 when it was determined that the inventory had a probable future economic benefit. These 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: September 30, 2020 Raw materials $ 317 Work in process (1) 2,441 Finished goods 406 Total $ 3,164 _____________________ (1) The work in process balance represents all production costs incurred for partially completed goods. |
Convertible Notes
Convertible Notes | 9 Months Ended |
Sep. 30, 2020 | |
Debt Disclosure [Abstract] | |
Convertible Notes | Convertible Notes On April 23, 2020, the Company entered into a Securities Purchase and Security Agreement (the Securities Purchase Agreement) with certain affiliates of Baker Bros. Advisors LP, as purchasers (the Purchasers), and Baker Bros. Advisors LP, as designated agent, pursuant to which the Company agreed to issue and sell to the 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 (the Baker First Closing Warrants). Following the Baker Initial Closing, the Purchasers had an option to purchase from the Company up to $10.0 million of Baker Notes (the Baker Purchase Rights) at the 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 Purchasers exercised the Baker Purchase Rights. At the second closing date of June 9, 2020, the Purchasers acquired the remaining Baker Notes with an aggregate principal amount of $10.0 million (the Baker Second Closing Notes) and Baker Warrants exercisable for 2,049,180 shares of common stock (the Baker Second Closing Warrants). With the completion of the underwritten public offering in June 2020 as further discussed in Note 11- Stockholders' Equity , 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 The Baker Notes are convertible at any time at the option the Purchasers at the aforementioned conversion price. 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 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 Securities Purchase Agreement, or 110% of the Outstanding Balance plus accrued and unpaid interest if the VWAP is less than such benchmark price. The 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 Securities Purchase Agreement, the repurchase price will equal 110% of the 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 Outstanding Balance plus (y) the aggregate value of future interest that would have accrued. 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 elected the FVO under ASC 825, Financial Instruments , for the Baker Notes as they 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 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 (ASC 480) 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 and Exercise Date the condensed consolidated statement of operations; (iii) an aggregate $34.1 million change in fair value 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 September 30, 2020, 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 an aggregate $3.1 million change in fair value of financial instruments as a result of mark-to-market adjustments recognized on the Baker Notes at the quarter ended September 30, 2020 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 September 30, 2020. The Baker Notes also include customary events of default as set forth in the Securities Purchase Agreement, such that, in an event of default, the Purchasers will have the right to accelerate repayment of the aggregate loan balance then outstanding. |
Balance Sheet Details
Balance Sheet Details | 9 Months Ended |
Sep. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Details | Balance Sheet Details Short-term Investments Short-term investments consist of held-to-maturity securities that will be due in one year or less. The following table illustrates the held-to-maturity securities’ amortized costs at purchase and the fair value for the period presented (in thousands). All of the short-term investments at December 31, 2019 have matured as of September 30, 2020. December 31, 2019 Amortized Cost Basis Unrealized Gains Fair Value Fixed income debt securities $ 8,233 $ 42 $ 8,275 Total held-to-maturity securities $ 8,233 $ 42 $ 8,275 Prepaid and other current assets consist of the following (in thousands): September 30, 2020 December 31, 2019 Selling and marketing related costs $ 7,654 $ 491 Insurance 1,324 481 Prepaid overhead 754 — Other receivables 213 436 Flex note receivable (1) 250 250 Short-term deposit 52 150 Other 391 505 Total $ 10,638 $ 2,313 _______________________ (1) In June 2016, Private Evofem’s board of directors committed to a plan to sell its Softcup line of business (Softcup) and re-direct its available cash resources to further develop Phexxi. 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 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 Maturity Date. 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 September 30, 2020 December 31, 2019 Research equipment 5 years $ 615 $ 608 Computer equipment and software 3 years 280 13 Office furniture 5 years 205 205 Leasehold improvements 5 years or less 340 340 Construction in-process — 1,566 77 3,006 1,243 Less: accumulated depreciation (1,030) (849) Total, net $ 1,976 $ 394 Depreciation expense was approximately $0.1 million for both the three months ended September 30, 2020 and 2019, and $0.2 million for both the nine months ended September 30, 2020 and 2019. Other Noncurrent Assets Other noncurrent assets consist of the following (in thousands): September 30, 2020 December 31, 2019 Restricted cash included in noncurrent assets $ 800 $ 750 Prepaid directors & officers' insurance 240 320 Flex note receivable, net of current portion — 250 Other 34 — Total $ 1,074 $ 1,320 Accrued Expenses Accrued expenses consist of the following (in thousands): September 30, 2020 December 31, 2019 Clinical studies $ 289 $ 585 Marketing and public relations 1,375 — Legal and other professional fees 1,276 1,652 Manufacturing related costs 1,413 — Other 254 547 Total $ 4,607 $ 2,784 |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 9 Months Ended |
Sep. 30, 2020 | |
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, investments in marketable fixed income debt securities classified as held-to-maturity and the Flex Note receivable, and the fair value of the Company’s convertible notes measured on a recurring basis are summarized in the following tables, as applicable (in thousands). September 30, 2020 Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs Money market funds (1) $ 81,585 $ 81,585 $ — $ — Fixed income debt securities classified as cash and cash equivalents 4,998 4,998 — — Flex note receivable 250 — 250 — Total assets $ 86,833 $ 86,583 $ 250 $ — Convertible notes payable (2) $ 47,063 $ — $ — $ 47,063 Total liabilities $ 47,063 $ — $ — $ 47,063 _____________________ (2) The convertible notes payable as of September 30, 2020 on the accompanying condensed consolidated balance sheet also includes approximately $1.0 million accrued interest on the Baker Notes. December 31, 2019 Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs Money market funds (1) $ 7,064 $ 7,064 $ — $ — Fixed income debt securities classified as cash and cash equivalents 6,749 — 6,749 — Fixed income debt securities classified as short-term investments 8,275 — 8,275 — Flex note receivable 500 — 500 — Total assets $ 22,588 $ 7,064 $ 15,524 $ — _______________________ (1) Included as a component of cash and cash equivalents on the accompanying condensed consolidated balance sheet. The Baker Warrants and the Baker Purchase Rights, and the Private Placement First Closing Warrants and the Private Placement Purchase Rights as discussed in Note 5- Convertible Notes and Note 10- 2019 Private Placement , respectively, 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 nine months ended September 30, 2020 and 2019. Baker First Closing Notes Baker Second Closing Notes Total Balance at June 30, 2020 $ 26,375 $ 17,583 $ 43,958 Change in fair value 1,863 1,242 3,105 Balance at September 30, 2020 (2) $ 28,238 $ 18,825 $ 47,063 Baker First Closing Notes Baker Second Closing Notes Total Balance at December 31, 2019 $ — $ — $ — Initial liability at issuance 37,405 20,715 58,120 Change in fair value (9,167) (1,890) (11,057) Balance at September 30, 2020 (2) $ 28,238 $ 18,825 $ 47,063 _____________________ (2) The convertible notes payable as of September 30, 2020 on the accompanying condensed consolidated balance sheet also includes approximately $1.0 million accrued interest on the Baker Notes. Baker First Closing Warrants Baker Purchase Rights Baker Second Closing Warrants Total Balance at December 31, 2019 $ — $ — $ — $ — Initial liability at issuance 14,007 27,636 5,098 46,741 Change in fair value (7,408) (11,823) (682) (19,913) 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 September 30, 2020 (3) $ — $ — $ — $ — Private Placement Warrants Private Placement Balance at December 31, 2018 $ — $ — Initial liability at issuance 3,611 3,183 Change in fair value 3,315 19,617 Reclassification from liability to equity (6,926) (22,800) Balance at September 30, 2019 (3) $ — $ — _____________________ (3) There was no activity for the three months ended September 30, 2020 and 2019. 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 September 30, 2020 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 and Private Placement Warrants The fair value of the Baker Warrants issued during the second quarter of 2020 as described in Note 5- Convertible Notes , and the fair value of the Private Placement First Closing Warrants issued during the second quarter of 2019 as described in Note 10- 2019 Private Placement , 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 periods indicated. Nine Months Ended September 30, 2020 2019 Expected volatility 93.7 % 75.0 % Risk-free interest rate 0.4 % 2.2 % Expected dividend yield — % — % Expected term (years) 4.9 6.9 Baker Purchase Rights and Private Placement Purchase Rights The fair value of the Baker Purchase Rights, and the subsequent change in fair value of these rights upon exercise of such rights, was determined as the maximum of (i) the fair value of rights to purchase the additional $10 million Baker Notes and (ii) the fair value of the shares of on as-if converted basis, which was determined by the lattice model. The fair value of rights to purchase an additional 2,049,180 Baker Warrants was valued using a Geske option-pricing model. The Geske model was based on the applicable assumptions, including the underlying stock price, warrant exercise price, the exercise price of the rights to purchase the Baker Warrants, the term of the Baker Warrants, the term of the rights to purchase the Baker Warrants, the expected volatility of the Company’s peer group, risk-free interest rate and expected dividend. The fair value of the Private Placement Purchase Rights issued in connection with the 2019 Private Placement, and the change in fair value of the Private Placement Purchase Rights as a result of the mark-to-market upon stockholder approval of the 2019 Private Placement, was determined using a combination of a lattice model and a Black-Scholes option-pricing model. The lattice model was used to determine a range of future value of the Company's common stock. The Black-Scholes option-pricing model was based on the applicable assumptions, including the future value of the Company's common stock as determined by the lattice model, warrant exercise price, time to expiration, expected volatility of our peer group, risk-free interest rate and expected dividend. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Operating Leases Fleet Lease In December 2019, the Company (the Lessee) and Enterprise FM Trust (the Lessor) entered into a Master Equity Lease Agreement (the Fleet 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 (the Fleet Lease). There was a total of 54 and 70 vehicles delivered during the three and nine months ended September 30, 2020, respectively. 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. This letter of credit was $0.1 million as of September 30, 2020. There was no such amount as of December 31, 2019. The Company determined that the leased vehicles are accounted for as operating leases under ASC 842 , Leases (ASC 842). 2020 Lease and the First Amendment On October 9, 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 (Expansion Premises), which commenced on September 1, 2020 (Expansion Premises Commencement Date) 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 September 30, 2020 and December 31, 2019, restricted cash maintained as collateral for the Company’s security deposit was $0.8 million. 2015 Lease Effective January 30, 2015, Private Evofem 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 sublease provided for two renewal periods of five Leased Space In August 2017, the Company entered into a manufacturing and supply agreement with an outside supplier for a term of one year from August 2017. This agreement was further renewed by both parties to cover the period from August 2018 to September 2019. Under the agreement, the supplier provides a dedicated packaging space for the Company at a fixed monthly cost. The Company determined that this dedicated space is accounted for as an operating lease under ASC 842 . The lease for this space expired in September 2019. Supplemental Financial Statement Information Lease Assets and Liabilities (in thousands) September 30, 2020 December 31, 2019 Operating right-of-use assets $ 7,198 $ 160 Operating lease liabilities- current $ 1,728 $ 197 Operating lease liabilities- noncurrent $ 6,425 $ — Three Months Ended September 30, Nine Months Ended September 30, Lease Cost (in thousands) Classification 2020 2019 2020 2019 Operating lease expense Research and development $ 118 $ 76 $ 273 $ 241 Operating lease expense Selling and marketing 167 38 298 79 Operating lease expense General and administrative 181 72 427 243 Total $ 466 $ 186 $ 998 $ 563 Lease Term and Discount Rate September 30, 2020 December 31, 2019 Weighted Average Remaining Lease Term (in years) 4.61 0.25 Weighted Average Discount Rate 12 % 12 % Maturity of Operating Lease Liabilities (in thousands) September 30, 2020 December 31, 2019 Remainder of 2020 $ 124 $ 201 Year ending December 31, 2021 2,450 — Year ending December 31, 2022 2,515 — Year ending December 31, 2023 2,171 — Year ending December 31, 2024 2,192 — Year ending December 31, 2025 1,502 — Total lease payments 10,954 201 Less: imputed interest (2,801) (4) Total $ 8,153 $ 197 Nine Months Ended September 30, Other information (in thousands) 2020 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash outflows in operating leases $ 552 $ 640 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 practices (cGMP) regulations, pursuant to which the Company has certain contractual commitments commencing in 2020. In accordance with the aforementioned Fleet Lease Agreement, the Company has certain contractual commitments for the vehicles to be delivered for use by the Company's sales force, for which ROU assets and lease liabilities will be recognized upon delivery. 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 September 30, 2020 and December 31, 2019, 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 these or other matters may arise from time to time that may harm the Company’s business. Intellectual Property Rights In 2014, Private Evofem entered into an amended and restated license agreement with Rush University (the Rush License Agreement) pursuant to which Rush University granted Private Evofem an exclusive, worldwide license of certain patents and know-how related to its multipurpose vaginal pH modulator technology authorizing Private Evofem to make, distribute and commercialize products and processes for any and all therapeutic, prophylactic and/or diagnostic uses, including, without limitation, use for female vaginal health and/or birth control. 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 payment was immaterial for the three months ended September 30, 2020. In October 2015, the Company entered into separate sublicense agreements (the Sublicenses) with WomanCare Global Trading CIC (WCGCIC) for a contraceptive vaginal ring for aggregate consideration of (i) payments or potential payments to WCGCIC of (a) an upfront payment of $10.0 million, (b) potential regulatory and commercial milestone payments up to $32.0 million, (c) potential royalty payments on net product sales and (d) potential royalty payments on net sales of an equivalent generic product and (ii) $5.0 million in annual sublicense fees through October 1, 2019 to WCGCIC. During the first quarter of 2019, the Sublicenses were reassigned to WCG Cares, upon which, the unpaid sublicense fees ceased accruing interest and all accrued sublicense fees and interest expense of $1.3 million were transferred and became payable to WCG Cares. During the third quarter of 2019, the Company and WCG Cares entered into a settlement agreement, whereby the Company paid $1.0 million to WCG Cares to settle the entire outstanding balance. The Company recorded the difference of $0.3 million as a concession recorded within other income (expense) in its condensed consolidated statement of operations during the third quarter of 2019. See Note 9- Related-party Transactions for a summary of the Company’s transactions with WCGCIC, WomanCare Global International, a non-profit organization registered in England and Wales (WCGI) and related entities, and WCG Cares. |
Related-party Transactions
Related-party Transactions | 9 Months Ended |
Sep. 30, 2020 | |
Related Party Transactions [Abstract] | |
Related-party Transactions | Related-party Transactions Consulting Agreements Effective April 1, 2017, the Company entered into a two Effective April 1, 2019, the Company entered into a new two Consulting fees incurred under the 2017 and 2019 Consulting Agreements were zero and $0.1 million for the three months ended September 30, 2020 and 2019, respectively, and $0.1 million and $0.5 million for the nine months ended September 30, 2020 and 2019, respectively. Transactions with WCGI and Related Entities From 2009 to 2016, Ms. Saundra Pelletier was the founding CEO of WCGI. In February 2013, Private Evofem and WCGI formed an alliance (the WCGI Alliance) and Ms. Pelletier also became Private Evofem’s CEO. Concurrent with the forming of the WCGI Alliance, Private Evofem and WCGI entered into a (i) service agreement to which the companies shared resources and employees and (ii) three From 2011 to 2017, Ms. Pelletier served as a director of the board of WomanCare Global Trading, Inc., a WCGI subsidiary. As described in Note 8- Commitments and Contingencies , in October 2015, Private Evofem, through its wholly-owned subsidiaries, entered into two sublicense agreements whereby Private Evofem was responsible for paying $5.0 million in annual sublicense fees, net of amounts paid under the grant agreement during 2015, to WCGCIC, also a WCGI affiliate. Effective January 2016, Private Evofem and WCGI entered into a shared-services agreement (the SSA), which replaced the prior service agreement. Under the terms of the SSA, Private Evofem and WCGI cross charged the other company’s services provided by each entity on behalf of the other. The SSA also allowed for netting of due to and due from shared-services fees. In July 2019, the SSA was terminated. Services provided under the SSA on behalf of WCGI were immaterial for the three and nine months ended September 30, 2019. The amounts of receivables and payables related to the Company’s transactions with WCGI related entities as of September 30, 2019 and for the three and nine months ended September 30, 2019 were immaterial. All accrued sublicense fees and interest expense related to the Sublicenses as of December 31, 2018 became payable to WCG Cares during the first quarter of 2019. Transactions with WCG Cares In 2013, WCG Cares, a 501(c)(3) nonprofit organization, was incorporated under the laws of the State of California. Its primary purpose is to directly engage in and/or fund the development and implementation of programs that promote reproductive health, education, research and increased access to high-quality, innovative and affordable reproductive healthcare and healthcare products around the world. Ms. Pelletier served as the CEO and President of WCG Cares from 2013 to November 2017. She was a member of its board from November 2017 to March 1, 2020, and also served as chair of its board of directors from November 2017 to May 2018. Additionally, Mr. Justin J. File served as WCG Cares' Chief Financial Officer from November 2017 to May 2018. Dr. Kelly Culwell served as WCG Cares' Chief Medical Officer from November 2017 to December 2018. Dr. Culwell was also appointed to its board of directors in January 2019 with a term of three years until December 31, 2021. In March 2018, the Company and WCG Cares entered into a shared-services agreement (the Cares Shared Services Agreement). Under the terms of the Cares Shared Services Agreement, the Company and WCG Cares cross charged services provided by each entity (or their subsidiaries) on behalf of the other. The Cares Shared Services Agreement also allowed for netting of due to and due from shared-services fees. In July 2019, the Company provided a notice of termination to WCG Cares to terminate the Cares Shared Services Agreement effective September 2019. Services provided under the Cares Shared Services Agreement on behalf of WCG Cares were immaterial for the three and nine months ended September 30, 2019, and the net shared-services due to the Company were immaterial as of September 30, 2019. Variable Interest Entity Considerations Due to shared management and numerous agreements between the Company and WCGI and the Company and WCG Cares, management reviewed its relationship with both WCGI and its subsidiaries and WCG Cares in accordance with the authoritative guidance for variable interest entities within ASC 810, Consolidation . The Company concluded that due to WCGI’s and WCG Cares’ status as not-for-profit entities the scope exception from qualifying as a variable interest entity was met and, therefore, the Company is not required to consolidate WCGI or WCG Cares. |
2019 Private Placement
2019 Private Placement | 9 Months Ended |
Sep. 30, 2020 | |
Private Placement [Abstract] | |
2019 Private Placement | 2019 Private Placement On April 10, 2019, the Company entered into a Securities Purchase Agreement with PDL BioPharma, Inc., a Delaware corporation (PDL), funds discretionally managed by Invesco Ltd. (Invesco) and funds managed by Woodford Investment Management Ltd. (WIM, collectively with Invesco and PDL, the 2019 Purchasers), providing for the issuance and sale to the 2019 Purchasers of an aggregate of up to $80 million of the Company’s common stock, par value $0.0001 per share (the Private Placement Shares) at a purchase price of $4.50 per share, and warrants to purchase shares of common stock with an exercise price of $6.38 per share (collectively, the Private Placement Securities) in a private placement (the Private Placement) to be funded in up to two separate closings. The first closing was completed on April 11, 2019 (the Private Placement First Closing), pursuant to which the Company (i) issued and sold to PDL 6,666,667 shares of its common stock and warrants to purchase up to 1,666,667 shares of common stock (the Private Placement First Closing Warrants) and (ii) provided to the 2019 Purchasers an option, but not an obligation, from the Company to issue and sell to each 2019 Purchaser the shares of common stock and warrants as specified in the aforementioned Securities Purchase Agreement during the period beginning on April 11, 2019 and ending on June 10, 2019 (the Private Placement Purchase Rights). The total consideration for the Private Placement First Closing was $30 million. The second closing was completed on June 10, 2019 (the Private Placement Second Closing), pursuant to which the Company issued and sold to PDL, Invesco and WIM (i) 6,666,667, 2,222,222 and 2,222,223 shares of its common stock, respectively and (ii) warrants to purchase up to 1,666,667, 555,556 and 555,556 shares of common stock (the Private Placement Second Closing Warrants), respectively, for an aggregate purchase price of $50 million. Shares of common stock issued to WIM included one voting share issued in connection with the issuance of its warrants. The Company’s stockholders approved the Private Placement at its 2019 Annual Meeting of Stockholders held on June 5, 2019 (the Private Placement Approval Date). The warrants have a 7-year term and will become exercisable at any time on or after the date that is six The Private Placement Second Closing Warrants were determined to be free standing financial instruments and equity classified in accordance with ASC 815, Derivatives and Hedging . The Company utilized the Black-Scholes option-pricing model to calculate the fair value of warrants at issuance and recorded an estimated fair value of $12.7 million as additional paid-in capital in the condensed consolidated balance sheet. The Company also determined the Private Placement Purchase Rights were free standing financial instruments and liability classified in accordance with ASC 480 due to the stockholder approval provision noted above. As described in Note 7- Fair Value Financial Instruments , the Company utilized a combination of a lattice model and a Black-Scholes option-pricing model to calculate the fair value of the Private Placement Purchase Rights at issuance and on the Private Placement Approval Date. The Company recorded the following in the condensed consolidated financial statements during the second quarter of 2019: (i) $3.2 million purchase rights liability at issuance for the purchase rights provided to PDL; (ii) $0.7 million loss on issuance of purchase rights at issuance in the condensed consolidated statement of operations for the purchase rights provided to Invesco and WIM; (iii) $19.6 million change in fair value of purchase rights in the condensed consolidated statement of operations as a result of mark-to-market on the Private Placement Approval Date; and (iv) $22.8 million reclassification from purchase rights liability to additional paid-in capital in the condensed consolidated balance sheet on the Private Placement Approval Date. Upon completion of the Private Placement First Closing and Private Placement Second Closing, the Company received proceeds of approximately $28.2 million and $47.2 million, net of $1.8 million and $2.8 million in advisory fees to financial advisors, respectively, and used these proceeds for clinical research and development purposes, including resubmission of the New Drug Application for Phexxi to the FDA, commercialization activities, and for general corporate purposes. Additionally, upon completion of the Private Placement Second Closing, the previously issued WIM Warrants and Reload Warrants (as defined below) to purchase up to 475,000 shares and 1,188,029 shares of common stock, respectively, were canceled. See Note 11- Stockholders' Equity |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2020 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders' Equity Warrants On February 5, 2019, the Company entered into letter agreements (the Repricing Letter Agreements) with WIM and certain other holders of outstanding warrants to purchase common stock of the Company by exercising certain outstanding warrants. Upon execution of the Repricing Letter Agreements, investment funds affiliated with WIM exercised certain warrants received upon the completion of the Merger (WIM Warrants) to purchase an aggregate of 1,525,000 shares of common stock, and WIM and other holders of common warrants issued in the public offering in May 2018 (Public Offering Warrants) exercised their common warrants to purchase an aggregate of 851,062 shares of common stock at a reduced exercise price of $2.64 per share. The Company received gross proceeds of approximately $6.3 million from these exercises. The Company determined that the incremental fair value as a result of the modification to these warrants from the change of the exercise price was approximately $1.4 million and $0.5 million for the WIM Warrants and Public Offering Warrants, respectively, which were recorded as a change in fair value of warrants in the condensed consolidated statement of operations for the nine months ended September 30, 2019. In addition, on February 8, 2019 and per the terms of the Repricing Letter Agreements, the Company issued warrants to purchase up to 1,188,029 shares of the Company’s common stock (Reload Warrants) to the holders' party to the Repricing Letter Agreements at an exercise price of $5.20 per share. The Company determined the Reload Warrants are free standing financial instruments and equity classified in accordance with ASC 480. Since the Reload Warrants were issued in addition to the reduced exercise price to induce the holders of WIM Warrants and common warrants to exercise their warrants, the Company determined the fair value of the Reload Warrants was also the incremental fair value as a result of the modification to the WIM warrants and common warrants exercised. To determine the fair value of the Reload Warrants, the Company utilized the Black-Scholes option-pricing model, which resulted in an estimated fair value of the Reload Warrants of $2.5 million, which was recorded as additional paid-in capital in the condensed consolidated balance sheet and change in fair value of warrants in the condensed consolidated statement of operations for the nine months ended September 30, 2019. On June 10, 2019, upon the Second Closing of the Private Placement as discussed in Note 10- 2019 Private Placement , the remaining WIM Warrants to purchase up to 475,000 shares of common stock and all Reload Warrants were cancelled. Warrants to purchase an aggregate of 4,444,446 shares of common stock were issued in connection with the Private Placement at an exercise price of $6.38 per share in April and June 2019. In April and June 2020, pursuant to the Securities Purchase Agreement as discussed in Note 5- Convertible Notes , the Company issued warrants to purchase up to 5,122,950 shares of common stock in a private placement at an exercise price of $2.44 per share. As of September 30, 2020, warrants to purchase up to 10,426,107 shares of the Company’s common stock remain outstanding at a weighted average exercise price of $4.54 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 Total 10,426,107 Common Stock Effective January 17, 2018 and in connection with the Merger, 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 Offering On June 5, 2020, the Company completed an underwritten public offering (the 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 Public Offering Price). The Company received proceeds from the 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 Public Offering Price, less applicable underwriting discounts. The common stock issued in the 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 June 10, 2020, the Company issued an additional 3,200,000 shares of common stock upon exercise of the underwriters’ overallotment option and received proceeds from the exercise of $10.5 million, net of underwriting discounts. At the Market (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 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 from time to time through Piper Sandler acting as sales agent. On June 2, 2020, in connection with the Public Offering discussed in Note 11- Stockholders’ Equity , the Equity Distribution Agreement was terminated. During the nine months ended September 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. Short-swing Profit Disgorgement During the three months ended September 30, 2020, there was no short-swing profit disgorgement. During the nine months ended September 30, 2020, the Company received an aggregate of $0.2 million in cash from short-swing profit disgorgement, which is included as an increase to additional paid-in capital in the condensed consolidated statement of stockholders’ equity and as a financing activity in the condensed consolidated statement of cash flows. Common Stock Reserved for Future Issuance Common stock reserved for future issuance is as follows in common equivalent shares as of September 30, 2020: Common stock issuable upon the exercise of stock options outstanding 8,972,112 Common stock issuable upon the exercise of common stock warrants 10,426,107 Common stock available for future issuance under the 2019 ESPP 1,354,968 Common stock available for future issuance under the Amended and Restated 2014 Plan 1,752,262 Common stock available for future issuance under the Amended Inducement Plan 484,175 Total common stock reserved for future issuance 22,989,624 Stockholder Rights Agreement On March 24, 2020, the Company entered into a rights agreement (the Rights Agreement) with Philadelphia Stock Transfer, Inc., as rights agent. In connection with the adoption of the Rights Agreement and pursuant to its terms, the Company’s board of directors authorized and declared a dividend of one right (each, a Right) for each outstanding share of the Company’s common stock to stockholders of record at the close of business on April 8, 2020 (the Record Date), and authorized the issuance of one Right for each share of common stock issued by the Company (except as otherwise provided in the Rights Agreement) between the Record Date and the Distribution Date (as defined below). Each Right entitles stockholders to purchase from the Company, when exercisable and subject to adjustment, one one-thousandth of a share (a Unit) of Series A Preferred Stock (the Preferred Stock) at a purchase price of $17.50 per Unit (the Purchase Price). The Rights generally become exercisable (the Distribution Date) upon the earlier of (i) 10 business days |
Stock-based Compensation
Stock-based Compensation | 9 Months Ended |
Sep. 30, 2020 | |
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 and non-employee directors included in the condensed consolidated statements of operations as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Research and development $ 291 $ 202 $ 1,689 $ 859 Selling and marketing 347 564 2,006 1,101 General and administrative 999 1,497 7,377 4,780 Total $ 1,637 $ 2,263 $ 11,072 $ 6,740 In September 2012, Private Evofem adopted the 2012 Equity Incentive Plan (the 2012 Plan) that 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, Neothetics’ 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 1,925,515 shares (Evergreen Shares) added to the total number of authorized shares on January 1, 2020. As of September 30, 2020, there were 1,752,262 shares available to grant under the Amended and Restated 2014 Plan. 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. As of September 30, 2020, there were 484,175 shares available to grant under the Inducement Plan. Stock Options There were 631,200 and 290,000 shares of stock options granted during the three months ended September 30, 2020 and 2019, respectiv ely, and 2,873,685 a nd 733,000 shares of stock options granted during the nine months ended September 30, 2020 and 2019, respectively. Of the total stock options granted during the nine months ended September 30, 2020, 1,027,400 were granted out of the share reserve increase approved by the board of directors under the Amended and Restated 2014 Plan on February 25, 2020 and were subject to the Company obtaining the requisite stockholder approval. This stockholder approval was obtained on May 12, 2020. As of September 30, 2020, unrecognized stock-based compensation expense for employees and non-employee stock options was approximately $10.9 million, which the Company expects to recognize over a weighted-average remaining period of 2.4 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 September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Expected volatility 90.7 % 76.0 % 82.4 % 76.1 % Risk-free interest rate 0.4 % 1.5 % 0.6 % 1.9 % Expected dividend yield — % — % — % — % Expected term (years) 6.1 6.0 6.0 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 zero and 150,000 shares of RSAs granted under the Amended and Restated 2014 Plan during the three months ended September 30, 2020 and 2019, respectively, and 1,265,000 and 625,500 shares of RSAs granted during the nine months ended September 30, 2020 and 2019 respectively, to its executive management team and certain non-executive employees. The vesting conditions for 1,245,000 shares of RSAs granted during the first quarter of 2020 and 460,500 shares of RSAs granted during the first quarter of 2019 are connected to the Company’s achievement of certain performance milestones in the corresponding fiscal year (Performance-based RSAs). For the Performance-based RSAs, (i) the fair value of the award was determined on the grant date, (ii) the Company assessed the probability of achieving each individual milestone associated with the award using reasonable assumptions based on the Company's operation performance towards each milestone and (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. The non-performance based RSAs and RSUs were valued at the fair value on the grant date and the associated expenses will be recognized over the vesting period. The Company recognized $0.1 million and $6.5 million stock-based compensation expense during the three and nine months ended September 30, 2020, respectively, for RSAs and RSUs. As of September 30, 2020, unrecognized stock-based compensation expense related to the unvested RSAs and RSUs was approximately $0.3 million, which the Company expects to recognize over a weighted-average remaining period of 1.3 years. On April 1, 2020, under the Amended and Restated 2014 Plan, the Company issued 150,000 RSUs to the former chairman of the Company’s board of directors in consideration for certain consulting services to be provided to the Company in connection with the 2019 Consulting Agreement, which were immediately forfeited upon the passing of Mr. Lynch. Employee Stock Purchase Plan In November 2014, Neothetics adopted the 2014 Employee Stock Purchase Plan (the 2014 ESPP), which initially authorized the issuance of 28,333 shares of common stock pursuant to purchase rights granted to employees, and an additional 258,672 evergreen shares were added to the total shares authorized on January 1, 2019. Following completion of the Merger, there was no enrollment in the 2014 ESPP. During the three and nine months ended September 30, 2019, there were no shares of common stock purchased under the 2014 ESPP. On May 7, 2019, the board of directors terminated the 2014 ESPP and approved a new 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. As of September 30, 2020, there were 1,354,968 shares of common stock reserved and available for issuance pursuant to the 2019 ESPP. 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 Code). 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, 2020 and will end on December 14, 2020. During the three and nine months ended September 30, 2020, there were zero and 67,454 shares of common stock purchased under the 2019 ESPP. During the three and nine months ended September 30, 2019, there were no shares of common stock purchased under the 2019 ESPP. 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 Nine Months Ended September 30, 2020 2019 Expected volatility 108.9 % 72.5 % Risk-free interest rate 0.2 % 2.2 % Expected dividend yield — % — % Expected term (years) 0.5 0.5 |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events Subsequent events were evaluated through the filing date of this Quarterly Report, November 9, 2020. On October 14, 2020, the Company sold and issued unsecured convertible promissory notes in an aggregate principal amount of $25 million (the Notes) to Adjuvant Global Health Technology Fund, L.P., and Adjuvant Global Health Technology Fund DE, L.P. (the 2020 Purchasers) pursuant to a Securities Purchase Agreement (the Purchase Agreement) by and between the Company and the 2020 Purchasers. Proceeds from the sale of the notes will be used to support EVOGUARD and to expand global market access for Phexxi. The Notes have a five of the Notes. The Notes are subordinate and junior in right of payment to the Baker Notes described in Note 5- Convertible Notes . The Notes are convertible, subject to certain beneficial ownership blockers, into shares of the Company’s common stock, at any time at the option of the 2020 Purchasers at a conversion price of $3.65 per share (the Conversion Price). 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. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation | 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. |
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, 2019 included in its Annual Report on Form 10-K as filed with the SEC on March 12, 2020 (the 2019 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 nine months ended September 30, 2020 are not necessarily indicative of the results expected for the full year. The condensed consolidated balance sheet as of December 31, 2019 was derived from the 2019 Audited Financial Statements. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and the notes thereto. S ignificant estimates affecting amounts reported or disclosed in the 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 (ROU) assets and lease liabilities, the assumptions used in estimating the fair value of 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. These assumptions are more fully described in Note 3- Revenue R eco gnition , Note 5- Convertible Notes , Note 7- Fair Value of Financial Instruments , Note 8- Commitments and Contingencies , and Note 12- 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 | 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 (CEO) 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 the 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, money market funds, and investments in fixed income debt securities with original maturities of less than three months. 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 . |
Trade Accounts Receivable | Trade Accounts Receivable and Allowance Trade accounts receivable are amounts owed to the Company by its customers for product that has been delivered. The trade accounts receivable are recorded at the invoice amount, less prompt pay and other discounts, chargebacks, and an allowance for credit losses, if any. The allowance for credit losses is the Company’s estimate of losses over the life of the receivables. The Company evaluates forward looking economic factors and uses professional judgment to determine the allowance for credit losses, as Phexxi was commercially launched in September 2020 and historical data is not yet available. The credit loss reserves are reviewed and adjusted periodically. |
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 Adopted Accounting Pronouncements and Recently Issued Accounting Pronouncements - Not Yet Adopted | Recently Adopted Accounting Pronouncements In June 2016, the Financial Accounting Standards Board (FASB) issued ASU No. 2016-13, Financial Instruments - Credit Losses , removing, modifying and adding certain disclosure requirements of ASC 326, Measurement of Credit Losses on Financial Instruments (ASU No. 2016-13), which requires credit losses relating to held-to maturity debt securities should be recorded through an allowance for credit losses. ASU No. 2016-13 was effective for the Company on January 1, 2020. The adoption of this new standard did not have a material impact on the Company's condensed consolidated financial statements. In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (ASU No. 2018-13), which removes, modifies and adds certain disclosure requirements on fair value measurements in ASC 820, Fair Value Measurements and Disclosures . ASU No. 2018-13 was effective for the Company on January 1, 2020. The adoption of this new standard did not have a material impact on the Company's condensed consolidated financial statements. In August 2018, the FASB issued ASU No. 2018-15, Intangibles—Goodwill and Other removing, modifying and adding certain disclosure requirements of ASC 350, Internal-Use Software (ASU No. 2018-15), which requires capitalizing implementation costs incurred to develop or obtain internal-use software in a cloud computing arrangement that is a service contract. ASU No. 2018-15 was effective for the Company on January 1, 2020. The adoption of this new standard did not have a material impact on the Company's condensed consolidated financial statements. Recently Issued Accounting Pronouncements — Not Yet Adopted In August 2020, the FASB 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 the expected impact of ASU 2020-06 on the condensed consolidated financial statements. |
Revenue Recognition | The Company recognizes revenue from the sale of its product, 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 and a specialty retail 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 . |
Inventory | Inventories, consisting of purchased materials, direct labor and manufacturing overheads, are stated at the lower of cost, or net realizable value. Cost is determined on a first-in, first-out basis. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. At each balance sheet date, the Company evaluates ending inventories for excess quantities, obsolescence, or shelf-life expiration. The evaluation includes an analysis of the Company’s current and future strategic plans, anticipated future sales, the price projections of future demand, and the remaining shelf life of goods on han d. To the extent that management determines there are excess or obsolete inventory or quantities with a shelf life that is too near its expiration for the Company to reasonably expect that it can sell those products prior to their expiration, the Company adjusts the carrying value to estimated net realizable value in accordance with the first-in, first-out inventory costing method. The Company began to capitalize the inventory costs associated with Phexxi in April 2020 when it was determined that the inventory had a probable future economic benefit. These 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: September 30, 2020 Raw materials $ 317 Work in process (1) 2,441 Finished goods 406 Total $ 3,164 _____________________ (1) The work in process balance represents all production costs incurred for partially completed goods. |
Convertible Notes | The Company elected the FVO under ASC 825, Financial Instruments |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
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): Nine Months Ended September 30, 2020 2019 Cash and cash equivalents $ 86,697 $ 32,120 Restricted cash 337 386 Restricted cash included in other noncurrent assets 800 — Total cash, cash equivalents and restricted cash presented in the condensed consolidated statements of cash flows $ 87,834 $ 32,506 |
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 Nine Months Ended September 30, 2020 2019 Unvested restricted stock awards subject to repurchase 70,000 421,300 Unvested restricted stock units — 113,000 Common stock to be purchased under the 2019 ESPP 64,442 55,132 Options to purchase common stock 8,972,112 6,424,179 Warrants to purchase common stock 10,426,107 6,168,815 Total 19,532,661 13,182,426 |
Revenue from Contract with Cust
Revenue from Contract with Customer (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Revenue from Contract with Customer [Abstract] | |
Schedule Of Product Revenue Variable Consideration Asset | The following table summarizes the balances and activity of product revenue variable consideration recorded as contra trade accounts receivable (in thousands): Total Balance at December 31, 2019 $ — Provision for the current period sales 123 Credit or payments made within the period (25) Balance at September 30, 2020 $ 98 |
Schedule Of Product Revenue Variable Consideration Liability | The following table summarizes the balances and activity of product revenue variable consideration recorded as other current liabilities (in thousands): Total Balance at December 31, 2019 $ — Provision for the current period sales 1,015 Credit or payments made within the period (94) Balance at September 30, 2020 $ 921 |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories | Inventories consist of the following (in thousands) for the period indicated: September 30, 2020 Raw materials $ 317 Work in process (1) 2,441 Finished goods 406 Total $ 3,164 _____________________ (1) The work in process balance represents all production costs incurred for partially completed goods. |
Balance Sheet Details (Tables)
Balance Sheet Details (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Short-term Investments | The following table illustrates the held-to-maturity securities’ amortized costs at purchase and the fair value for the period presented (in thousands). All of the short-term investments at December 31, 2019 have matured as of September 30, 2020. December 31, 2019 Amortized Cost Basis Unrealized Gains Fair Value Fixed income debt securities $ 8,233 $ 42 $ 8,275 Total held-to-maturity securities $ 8,233 $ 42 $ 8,275 |
Prepaid and Other Current Assets | Prepaid and other current assets consist of the following (in thousands): September 30, 2020 December 31, 2019 Selling and marketing related costs $ 7,654 $ 491 Insurance 1,324 481 Prepaid overhead 754 — Other receivables 213 436 Flex note receivable (1) 250 250 Short-term deposit 52 150 Other 391 505 Total $ 10,638 $ 2,313 _______________________ (1) In June 2016, Private Evofem’s board of directors committed to a plan to sell its Softcup line of business (Softcup) and re-direct its available cash resources to further develop Phexxi. In July 2016, the Company entered into an Asset Purchase |
Property and Equipment, Net | Property and equipment, net, consists of the following (in thousands): Useful Life September 30, 2020 December 31, 2019 Research equipment 5 years $ 615 $ 608 Computer equipment and software 3 years 280 13 Office furniture 5 years 205 205 Leasehold improvements 5 years or less 340 340 Construction in-process — 1,566 77 3,006 1,243 Less: accumulated depreciation (1,030) (849) Total, net $ 1,976 $ 394 |
Other Noncurrent Assets | Other noncurrent assets consist of the following (in thousands): September 30, 2020 December 31, 2019 Restricted cash included in noncurrent assets $ 800 $ 750 Prepaid directors & officers' insurance 240 320 Flex note receivable, net of current portion — 250 Other 34 — Total $ 1,074 $ 1,320 |
Accrued Expenses | Accrued expenses consist of the following (in thousands): September 30, 2020 December 31, 2019 Clinical studies $ 289 $ 585 Marketing and public relations 1,375 — Legal and other professional fees 1,276 1,652 Manufacturing related costs 1,413 — Other 254 547 Total $ 4,607 $ 2,784 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
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, investments in marketable fixed income debt securities classified as held-to-maturity and the Flex Note receivable, and the fair value of the Company’s convertible notes measured on a recurring basis are summarized in the following tables, as applicable (in thousands). September 30, 2020 Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs Money market funds (1) $ 81,585 $ 81,585 $ — $ — Fixed income debt securities classified as cash and cash equivalents 4,998 4,998 — — Flex note receivable 250 — 250 — Total assets $ 86,833 $ 86,583 $ 250 $ — Convertible notes payable (2) $ 47,063 $ — $ — $ 47,063 Total liabilities $ 47,063 $ — $ — $ 47,063 _____________________ (2) The convertible notes payable as of September 30, 2020 on the accompanying condensed consolidated balance sheet also includes approximately $1.0 million accrued interest on the Baker Notes. December 31, 2019 Quoted Prices in Active Markets for Identical Assets Significant Other Observable Inputs Significant Unobservable Inputs Money market funds (1) $ 7,064 $ 7,064 $ — $ — Fixed income debt securities classified as cash and cash equivalents 6,749 — 6,749 — Fixed income debt securities classified as short-term investments 8,275 — 8,275 — Flex note receivable 500 — 500 — Total assets $ 22,588 $ 7,064 $ 15,524 $ — _______________________ (1) Included as a component of cash and cash equivalents on the accompanying condensed consolidated balance sheet. |
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 nine months ended September 30, 2020 and 2019. Baker First Closing Notes Baker Second Closing Notes Total Balance at June 30, 2020 $ 26,375 $ 17,583 $ 43,958 Change in fair value 1,863 1,242 3,105 Balance at September 30, 2020 (2) $ 28,238 $ 18,825 $ 47,063 Baker First Closing Notes Baker Second Closing Notes Total Balance at December 31, 2019 $ — $ — $ — Initial liability at issuance 37,405 20,715 58,120 Change in fair value (9,167) (1,890) (11,057) Balance at September 30, 2020 (2) $ 28,238 $ 18,825 $ 47,063 _____________________ (2) The convertible notes payable as of September 30, 2020 on the accompanying condensed consolidated balance sheet also includes approximately $1.0 million accrued interest on the Baker Notes. Baker First Closing Warrants Baker Purchase Rights Baker Second Closing Warrants Total Balance at December 31, 2019 $ — $ — $ — $ — Initial liability at issuance 14,007 27,636 5,098 46,741 Change in fair value (7,408) (11,823) (682) (19,913) 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 September 30, 2020 (3) $ — $ — $ — $ — Private Placement Warrants Private Placement Balance at December 31, 2018 $ — $ — Initial liability at issuance 3,611 3,183 Change in fair value 3,315 19,617 Reclassification from liability to equity (6,926) (22,800) Balance at September 30, 2019 (3) $ — $ — _____________________ |
Fair Value Measurement Inputs | The fair value of the Baker Warrants issued during the second quarter of 2020 as described in Note 5- Convertible Notes , and the fair value of the Private Placement First Closing Warrants issued during the second quarter of 2019 as described in Note 10- 2019 Private Placement , 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 periods indicated. Nine Months Ended September 30, 2020 2019 Expected volatility 93.7 % 75.0 % Risk-free interest rate 0.4 % 2.2 % Expected dividend yield — % — % Expected term (years) 4.9 6.9 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Supplemental Financial Information, Lease Assets and Liabilities and Lease Term and Discount Rate | Supplemental Financial Statement Information Lease Assets and Liabilities (in thousands) September 30, 2020 December 31, 2019 Operating right-of-use assets $ 7,198 $ 160 Operating lease liabilities- current $ 1,728 $ 197 Operating lease liabilities- noncurrent $ 6,425 $ — Lease Term and Discount Rate September 30, 2020 December 31, 2019 Weighted Average Remaining Lease Term (in years) 4.61 0.25 Weighted Average Discount Rate 12 % 12 % |
Supplemental Financial Information, Lease Cost and Other information | Three Months Ended September 30, Nine Months Ended September 30, Lease Cost (in thousands) Classification 2020 2019 2020 2019 Operating lease expense Research and development $ 118 $ 76 $ 273 $ 241 Operating lease expense Selling and marketing 167 38 298 79 Operating lease expense General and administrative 181 72 427 243 Total $ 466 $ 186 $ 998 $ 563 Nine Months Ended September 30, Other information (in thousands) 2020 2019 Cash paid for amounts included in the measurement of lease liabilities: Operating cash outflows in operating leases $ 552 $ 640 |
Maturities of Lease Liabilities | Maturity of Operating Lease Liabilities (in thousands) September 30, 2020 December 31, 2019 Remainder of 2020 $ 124 $ 201 Year ending December 31, 2021 2,450 — Year ending December 31, 2022 2,515 — Year ending December 31, 2023 2,171 — Year ending December 31, 2024 2,192 — Year ending December 31, 2025 1,502 — Total lease payments 10,954 201 Less: imputed interest (2,801) (4) Total $ 8,153 $ 197 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Equity [Abstract] | |
Summary of Warrants | As of September 30, 2020, warrants to purchase up to 10,426,107 shares of the Company’s common stock remain outstanding at a weighted average exercise price of $4.54 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 Total 10,426,107 |
Summary of Common Stock Reserved for Future Issuance | Common stock reserved for future issuance is as follows in common equivalent shares as of September 30, 2020: Common stock issuable upon the exercise of stock options outstanding 8,972,112 Common stock issuable upon the exercise of common stock warrants 10,426,107 Common stock available for future issuance under the 2019 ESPP 1,354,968 Common stock available for future issuance under the Amended and Restated 2014 Plan 1,752,262 Common stock available for future issuance under the Amended Inducement Plan 484,175 Total common stock reserved for future issuance 22,989,624 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Share-based Payment Arrangement [Abstract] | |
Summary of Stock-based Compensation Expense Related to Stock Options, Restricted Stock Awards (RSAs) and RSUs Granted to Employees and Non-employee Directors | The following table summarizes stock-based compensation expense related to stock options, restricted stock awards (RSAs) and RSUs granted to employees and non-employee directors included in the condensed consolidated statements of operations as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Research and development $ 291 $ 202 $ 1,689 $ 859 Selling and marketing 347 564 2,006 1,101 General and administrative 999 1,497 7,377 4,780 Total $ 1,637 $ 2,263 $ 11,072 $ 6,740 |
Weighted Average Assumptions Used in Calculation of Fair Value of Shares and Stock Options Granted to Employees and Non-employees | 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 September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Expected volatility 90.7 % 76.0 % 82.4 % 76.1 % Risk-free interest rate 0.4 % 1.5 % 0.6 % 1.9 % Expected dividend yield — % — % — % — % Expected term (years) 6.1 6.0 6.0 5.9 Three and Nine Months Ended September 30, 2020 2019 Expected volatility 108.9 % 72.5 % Risk-free interest rate 0.2 % 2.2 % 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 | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Entity Information [Line Items] | |||||
Selling and marketing expense adjustment | $ 14,700 | $ 3,791 | $ 32,553 | $ 6,222 | |
Proceeds from issuance of common stock | 103,738 | 0 | |||
Proceeds from issuance of common stock, net of commissions - ATM transactions | 3,781 | 0 | |||
Cash, cash equivalents, and short-term investments | 86,700 | 86,700 | |||
Working capital | 36,400 | 36,400 | |||
Accumulated deficit | $ (614,890) | (614,890) | $ (513,179) | ||
Public Offering | |||||
Entity Information [Line Items] | |||||
Proceeds from issuance of common stock, net of commissions - ATM transactions | 3,800 | ||||
Revision of Prior Period, Reclassification, Adjustment | |||||
Entity Information [Line Items] | |||||
Selling, general and administrative expense | 3,800 | 6,200 | |||
Selling and marketing expense adjustment | $ 3,800 | $ 6,200 | |||
Senior Convertible Notes Payable | |||||
Entity Information [Line Items] | |||||
Proceeds from issuance of long-term convertible notes | $ 25,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) | 9 Months Ended |
Sep. 30, 2020Segment | |
Accounting Policies [Abstract] | |
Number of operating segments | 1 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Dec. 31, 2018 |
Cash and Cash Equivalents [Line Items] | ||||
Cash and cash equivalents | $ 86,697 | $ 15,571 | $ 32,120 | |
Restricted cash | 337 | 304 | 386 | |
Restricted cash included in other noncurrent assets | 800 | 750 | ||
Total cash, cash equivalents and restricted cash presented in the condensed consolidated statements of cash flows | 87,834 | $ 16,625 | 32,506 | $ 1,761 |
Other Noncurrent Assets | ||||
Cash and Cash Equivalents [Line Items] | ||||
Restricted cash included in other noncurrent assets | $ 800 | $ 0 |
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 | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total (in shares) | 19,532,661 | 13,182,426 | 19,532,661 | 13,182,426 |
Unvested restricted stock awards subject to repurchase | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total (in shares) | 70,000 | 421,300 | 70,000 | 421,300 |
Unvested restricted stock units | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total (in shares) | 0 | 113,000 | 0 | 113,000 |
Common stock to be purchased under the 2019 ESPP | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total (in shares) | 64,442 | 55,132 | 64,442 | 55,132 |
Options to purchase common stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total (in shares) | 8,972,112 | 6,424,179 | 8,972,112 | 6,424,179 |
Warrants to purchase common stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Total (in shares) | 10,426,107 | 6,168,815 | 10,426,107 | 6,168,815 |
Revenue Recognition - Schedule
Revenue Recognition - Schedule of Product Revenue Variable Consideration Asset (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2020USD ($) | |
Product Revenue, Variable Consideration Asset [Roll Forward] | |
Balance at December 31, 2019 | $ 0 |
Provision for the current period sales | 123 |
Credit or payments made within the period | (25) |
Balance at September 30, 2020 | $ 98 |
Revenue Recognition - Schedul_2
Revenue Recognition - Schedule of Product Revenue Variable Consideration Liability (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2020USD ($) | |
Product Revenue, Variable Consideration Rollforward [Roll Forward] | |
Balance at December 31, 2019 | $ 0 |
Provision for the current period sales | 1,015 |
Credit or payments made within the period | (94) |
Balance at September 30, 2020 | $ 921 |
Inventories - Schedule of Inven
Inventories - Schedule of Inventories (Details) $ in Thousands | Sep. 30, 2020USD ($) |
Inventory Disclosure [Abstract] | |
Raw materials | $ 317 |
Work in process | 2,441 |
Finished goods | 406 |
Total | $ 3,164 |
Convertible Notes (Details)
Convertible Notes (Details) - USD ($) | Jun. 18, 2020 | Jun. 05, 2020 | Apr. 24, 2020 | Mar. 24, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Apr. 23, 2020 |
Debt Instrument [Line Items] | ||||||||||
Securities sold under purchase agreement | $ 15,000,000 | |||||||||
Stock option warrants to purchase common stock (in shares) | 0.001 | |||||||||
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) | $ 2.44 | $ 0.0175 | $ 4.54 | $ 4.54 | ||||||
Term | 5 years | 10 days | ||||||||
Interest expense | $ 992,000 | $ 0 | ||||||||
Convertible notes | $ 58,100,000 | |||||||||
Warrants and purchase rights issued | 46,700,000 | |||||||||
Loss on issuance of financial instruments | $ 0 | 64,000,000 | $ 0 | 64,049,000 | 674,000 | |||||
Change in fair value of financial instruments | 3,105,000 | (34,100,000) | $ 0 | (30,971,000) | $ 27,372,000 | |||||
Reclassification of purchase rights liability | $ 15,800,000 | |||||||||
Reclassification from financial instruments liability to equity | $ 11,000,000 | $ 11,015,000 | ||||||||
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% | |||||||||
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 | |||||||||
Baker First Closing Warrants | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Stock option warrants to purchase common stock (in shares) | 3,073,770 | |||||||||
Baker Second Closing Warrants | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Stock option warrants to purchase common stock (in shares) | 2,049,180 | |||||||||
Period Two | Senior Convertible Notes Payable | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Redemption price, percentage | 100.00% | |||||||||
Period One | Senior Convertible Notes Payable | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Redemption price, percentage | 110.00% | |||||||||
Period Three | Senior Convertible Notes Payable | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Redemption price, percentage | 110.00% | |||||||||
Senior Convertible Notes Payable | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Interest expense | $ 700,000 | $ 1,000,000 |
Balance Sheet Details - Short-t
Balance Sheet Details - Short-term Investments (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Schedule of Held-to-maturity Securities [Line Items] | ||
Amortized Cost Basis | $ 0 | $ 8,233 |
Unrealized Gains | 42 | |
Fair Value | 8,275 | |
Fixed income debt securities | ||
Schedule of Held-to-maturity Securities [Line Items] | ||
Amortized Cost Basis | 8,233 | |
Unrealized Gains | 42 | |
Fair Value | $ 8,275 |
Balance Sheet Details - Prepaid
Balance Sheet Details - Prepaid and Other Current Assets (Details) - USD ($) $ in Thousands | Jul. 31, 2016 | Sep. 30, 2020 | Dec. 31, 2019 |
Prepaid Expenses And Other Current Assets [Line Items] | |||
Prepaid and other current assets | $ 10,638 | $ 2,313 | |
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 | 7,654 | 491 | |
Insurance | |||
Prepaid Expenses And Other Current Assets [Line Items] | |||
Prepaid and other current assets | 1,324 | 481 | |
Prepaid overhead | |||
Prepaid Expenses And Other Current Assets [Line Items] | |||
Prepaid and other current assets | 754 | 0 | |
Other receivables | |||
Prepaid Expenses And Other Current Assets [Line Items] | |||
Prepaid and other current assets | 213 | 436 | |
Flex note receivable | |||
Prepaid Expenses And Other Current Assets [Line Items] | |||
Prepaid and other current assets | 250 | 250 | |
Short-term deposit | |||
Prepaid Expenses And Other Current Assets [Line Items] | |||
Prepaid and other current assets | 52 | 150 | |
Other | |||
Prepaid Expenses And Other Current Assets [Line Items] | |||
Prepaid and other current assets | $ 391 | $ 505 |
Balance Sheet Details - Propert
Balance Sheet Details - Property and Equipment, Net (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, gross | $ 3,006 | $ 3,006 | $ 1,243 | ||
Less: accumulated depreciation | (1,030) | (1,030) | (849) | ||
Total, net | 1,976 | 1,976 | 394 | ||
Depreciation expense | 100 | $ 100 | $ 200 | $ 200 | |
Research equipment | |||||
Property, Plant and Equipment [Line Items] | |||||
Useful Life | 5 years | ||||
Property and equipment, gross | 615 | $ 615 | 608 | ||
Computer equipment and software | |||||
Property, Plant and Equipment [Line Items] | |||||
Useful Life | 3 years | ||||
Property and equipment, gross | 280 | $ 280 | 13 | ||
Office furniture | |||||
Property, Plant and Equipment [Line Items] | |||||
Useful Life | 5 years | ||||
Property and equipment, gross | 205 | $ 205 | 205 | ||
Leasehold improvements | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, gross | 340 | 340 | 340 | ||
Construction in-process | |||||
Property, Plant and Equipment [Line Items] | |||||
Property and equipment, gross | $ 1,566 | $ 1,566 | $ 77 | ||
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 | Sep. 30, 2020 | Dec. 31, 2019 |
Restricted cash included in noncurrent assets | $ 800 | $ 750 |
Other noncurrent assets | 1,074 | 1,320 |
Other | 34 | |
Flex note receivable | ||
Other noncurrent assets | 0 | 250 |
Other | 0 | |
Prepaid directors & officers' insurance | ||
Other noncurrent assets | $ 240 | $ 320 |
Balance Sheet Details - Accrued
Balance Sheet Details - Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Clinical studies | $ 289 | $ 585 |
Marketing and public relations | 1,375 | 0 |
Legal and other professional fees | 1,276 | 1,652 |
Manufacturing related costs | 1,413 | 0 |
Other | 254 | 547 |
Total | $ 4,607 | $ 2,784 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments - Fair Values of Assets Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total assets | $ 86,833 | $ 22,588 |
Convertible notes payable (2) | 47,063 | |
Total liabilities | 47,063 | |
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 | 86,583 | 7,064 |
Convertible notes payable (2) | 0 | |
Total liabilities | 0 | |
Significant Other Observable Inputs (Level 2) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total assets | 250 | 15,524 |
Convertible notes payable (2) | 0 | |
Total liabilities | 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 (2) | 47,063 | |
Total liabilities | 47,063 | |
Money market funds | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total assets | 81,585 | 7,064 |
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 | 81,585 | 7,064 |
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 |
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 | 4,998 | |
Fixed income debt securities classified as cash and cash equivalents | 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 | 4,998 | |
Fixed income debt securities classified as cash and cash equivalents | Significant Other Observable Inputs (Level 2) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total assets | 0 | |
Fixed income debt securities classified as cash and cash equivalents | Significant Unobservable Inputs (Level 3) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total assets | 0 | |
Flex note receivable | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total assets | 250 | 500 |
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 | 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 | 500 |
Flex note receivable | Significant Unobservable Inputs (Level 3) | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Total assets | $ 0 | 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 | 6,749 | |
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 | 0 | |
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 | 6,749 | |
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 | |
Short-term Investments | 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 | 8,275 | |
Short-term Investments | 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 | 0 | |
Short-term Investments | 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 | 8,275 | |
Short-term Investments | 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) - Significant Unobservable Inputs (Level 3) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2020 | Sep. 30, 2019 | |
Debt | |||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Beginning balance | $ 43,958 | $ 0 | |
Initial liability at issuance | 58,120 | ||
Change in fair value | 3,105 | (11,057) | |
Ending balance | 47,063 | 47,063 | |
Warrant Liability | |||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Beginning balance | $ 0 | ||
Initial liability at issuance | 3,611 | ||
Change in fair value | 3,315 | ||
Reclassification from liability to equity | (6,926) | ||
Ending balance | 0 | ||
Warrants and Purchase Rights Liability | |||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Beginning balance | 0 | ||
Initial liability at issuance | 46,741 | ||
Change in fair value | (19,913) | ||
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 | 0 | 0 | |
Baker First Closing Warrants | Warrant Liability | |||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Beginning balance | 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 | 0 | |
Baker Purchase Rights | Purchase Rights Liability | |||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Beginning balance | 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 | 0 | |
Baker Second Closing Warrants | Warrant Liability | |||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Beginning balance | 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 | 0 | |
Private Placement Purchase Rights | Purchase Rights Liability | |||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Beginning balance | 0 | ||
Initial liability at issuance | 3,183 | ||
Change in fair value | 19,617 | ||
Reclassification from liability to equity | (22,800) | ||
Ending balance | $ 0 | ||
Baker First Closing Notes | Debt | |||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Beginning balance | 26,375 | 0 | |
Initial liability at issuance | 37,405 | ||
Change in fair value | 1,863 | (9,167) | |
Ending balance | 28,238 | 28,238 | |
Baker Second Closing Notes | Debt | |||
Fair Value, Net Derivative Asset (Liability) Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |||
Beginning balance | 17,583 | 0 | |
Initial liability at issuance | 20,715 | ||
Change in fair value | 1,242 | (1,890) | |
Ending balance | $ 18,825 | $ 18,825 |
Fair Value of Financial Instr_5
Fair Value of Financial Instruments - Fair Value Measurement Inputs (Details) | Sep. 30, 2020 | Sep. 30, 2019 |
Expected volatility | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Fair value, measurement input | 0.937 | 0.750 |
Risk-free interest rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Fair value, measurement input | 0.004 | 0.022 |
Expected dividend yield | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Fair value, measurement input | 0 | 0 |
Expected term (years) | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Fair value, measurement input | 4.9 | 6.9 |
Fair Value of Financial Instr_6
Fair Value of Financial Instruments - Additional Information (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2020 | Sep. 30, 2020 | Sep. 30, 2019 | Jun. 05, 2020 | Apr. 24, 2020 | Mar. 24, 2020 | |
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||
Interest expense | $ 992,000 | $ 0 | ||||
Purchase agreement, amount of securities purchasable under agreement (up to) | $ 10,000,000 | |||||
Stock option warrants to purchase common stock (in shares) | 0.001 | |||||
Baker Second Closing Notes | ||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||
Stock option warrants to purchase common stock (in shares) | 2,049,180 | |||||
Senior Convertible Notes Payable | ||||||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||||||
Interest expense | $ 700,000 | $ 1,000,000 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) | Jan. 01, 2021USD ($) | Oct. 31, 2015USD ($) | Sep. 30, 2020USD ($)vehicleclaim | Sep. 30, 2019USD ($) | Mar. 31, 2020USD ($) | Sep. 30, 2020USD ($)vehicleclaim | Oct. 01, 2019USD ($) | Nov. 30, 2019USD ($) | Apr. 14, 2020USD ($)ft² | Dec. 31, 2019USD ($)claim | Oct. 09, 2019USD ($)ft² | Mar. 31, 2019USD ($) | Jan. 30, 2015renewal_term |
Loss Contingencies [Line Items] | |||||||||||||
Number of vehicles delivered | vehicle | 54 | 70 | |||||||||||
Restricted cash | $ 337,000 | $ 386,000 | $ 337,000 | $ 304,000 | |||||||||
Office area (in square feet) | ft² | 8,816 | 24,474 | |||||||||||
Renewal period | 5 years | 5 years | |||||||||||
Number of renewal options | renewal_term | 2 | ||||||||||||
Periodic release of security deposit | $ 66,000 | $ 5,000 | |||||||||||
Claims | claim | 0 | 0 | 0 | ||||||||||
Accrued sublicense fees | $ 1,300,000 | ||||||||||||
Forecast | Rush University | Royalty Agreement Terms | |||||||||||||
Loss Contingencies [Line Items] | |||||||||||||
Minimum annual royalty amount | $ 100,000 | ||||||||||||
Forecast | Maximum | Rush University | |||||||||||||
Loss Contingencies [Line Items] | |||||||||||||
Maximum for earned royalties | $ 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 | ||||||||||||
WCG Cares Sublicense Agreement | |||||||||||||
Loss Contingencies [Line Items] | |||||||||||||
Settlement payment for sublicense agreement | 1,000,000 | ||||||||||||
Other income | $ 300,000 | ||||||||||||
Woman Care Global International | Sublicense Agreement | |||||||||||||
Loss Contingencies [Line Items] | |||||||||||||
Upfront license payment | $ 10,000,000 | ||||||||||||
Maximum milestone license payment | $ 32,000,000 | ||||||||||||
Annual sublicense fees | $ 5,000,000 | ||||||||||||
Vehicles | Securities Deposit | |||||||||||||
Loss Contingencies [Line Items] | |||||||||||||
Restricted cash | $ 100,000 | $ 100,000 | $ 0 | ||||||||||
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 |
Commitments and Contingencies_2
Commitments and Contingencies - Supplemental Financial Statement Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2019 | |
Lessee, Lease, Description [Line Items] | |||||
Operating right-of-use assets | $ 7,198 | $ 7,198 | $ 160 | ||
Operating lease liabilities – current | 1,728 | 1,728 | 197 | ||
Operating lease liabilities- noncurrent | 6,425 | 6,425 | $ 0 | ||
Operating lease expense | $ 466 | $ 186 | $ 998 | $ 563 | |
Weighted Average Remaining Lease Term (in years) | 4 years 7 months 9 days | 4 years 7 months 9 days | 3 months | ||
Weighted Average Discount Rate (percent) | 12.00% | 12.00% | 12.00% | ||
Research and development | |||||
Lessee, Lease, Description [Line Items] | |||||
Operating lease expense | $ 118 | 76 | $ 273 | 241 | |
Selling and marketing | |||||
Lessee, Lease, Description [Line Items] | |||||
Operating lease expense | 167 | 38 | 298 | 79 | |
General and administrative | |||||
Lessee, Lease, Description [Line Items] | |||||
Operating lease expense | $ 181 | $ 72 | $ 427 | $ 243 |
Commitments and Contingencies_3
Commitments and Contingencies - Future Operating Lease Maturities (Details) - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Maturity of Operating Lease Liabilities | ||
Remainder of 2020 | $ 124 | $ 201 |
Year ending December 31, 2021 | 2,450 | 0 |
Year ending December 31, 2022 | 2,515 | 0 |
Year ending December 31, 2023 | 2,171 | 0 |
Year ending December 31, 2024 | 2,192 | 0 |
Year ending December 31, 2025 | 1,502 | 0 |
Total lease payments | 10,954 | 201 |
Less: imputed interest | (2,801) | (4) |
Total | $ 8,153 | $ 197 |
Commitments and Contingencies_4
Commitments and Contingencies - Supplemental Cash Flow Information (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Commitments and Contingencies Disclosure [Abstract] | ||
Operating cash outflows in operating leases | $ 552 | $ 640 |
Related-Party Transactions - Ad
Related-Party Transactions - Additional Information (Details) $ in Thousands | Apr. 01, 2020shares | Apr. 01, 2019USD ($)shares | Apr. 01, 2017USD ($)shares | Jan. 31, 2019 | Oct. 31, 2015Agreement | Feb. 28, 2013 | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Dec. 31, 2015USD ($) | Mar. 24, 2020shares |
Related Party Transaction [Line Items] | ||||||||||||
Stock option warrants to purchase common stock (in shares) | shares | 0.001 | |||||||||||
Potential bonus as a percent of consulting fees earned (percent) | 100.00% | |||||||||||
Number of sublicenses | Agreement | 2 | |||||||||||
Cost of goods sold | $ 317 | $ 0 | $ 317 | $ 0 | ||||||||
Thomas Lynch | Consulting Agreement 2017 | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Vesting period | 2 years | |||||||||||
Compensation relates management service | $ 400 | |||||||||||
Stock option warrants to purchase common stock (in shares) | shares | 6,416 | |||||||||||
Thomas Lynch | Consulting Agreement 2017 | Board service | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Compensation relates management service | $ 100 | |||||||||||
Thomas Lynch | Consulting Agreement 2019 | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Vesting period | 2 years | |||||||||||
Compensation relates management service | $ 400 | |||||||||||
Thomas Lynch | Consulting Agreement 2019 | Board service | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Compensation relates management service | $ 100 | |||||||||||
Thomas Lynch | Consulting Agreements | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Compensation paid | $ 0 | $ 100 | $ 100 | $ 500 | ||||||||
Woman Care Global International | Grant Agreement | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Grant agreement term | 3 years | |||||||||||
WCG Cares | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Board term | 3 years | |||||||||||
Amended and Restated 2014 Plan | Chairman | Unvested restricted stock units | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Vesting period | 1 year | |||||||||||
Issued RSU for the right to shares common stock (in shares) | shares | 150,000 | 150,000 | ||||||||||
Licenses | Woman Care Global International | ||||||||||||
Related Party Transaction [Line Items] | ||||||||||||
Cost of goods sold | $ 5,000 |
2019 Private Placement - Additi
2019 Private Placement - Additional Information (Details) - USD ($) | Jun. 10, 2019 | Jun. 05, 2019 | Apr. 11, 2019 | Apr. 10, 2019 | Jun. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Jun. 05, 2020 | Mar. 24, 2020 | Dec. 31, 2019 | Feb. 08, 2019 | Jan. 17, 2018 |
Class of Warrant or Right [Line Items] | ||||||||||||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||||||||
Stock option warrant to purchase, exercise price per share (in dollars per share) | $ 4.54 | $ 2.44 | $ 0.0175 | |||||||||
Common stock issued upon the exercise of common stock warrants (in shares) | 0.001 | |||||||||||
Warrant liability | $ 3,600,000 | |||||||||||
Change in fair value of warrants | $ 3,300,000 | |||||||||||
Reclassification from warrant liability to additional paid-in capital | 6,900,000 | |||||||||||
Purchase right liability | 3,200,000 | |||||||||||
Loss on issuance of Purchase Rights | 700,000 | |||||||||||
Change in fair value of Purchase Rights | 19,600,000 | |||||||||||
Reclassification from purchase rights liability to additional paid-in capital | $ 22,800,000 | |||||||||||
Advisory fees to financial advisors | $ 867,000 | $ 1,180,000 | ||||||||||
Securities Purchase Agreement | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Transaction value | $ 80,000,000 | |||||||||||
Common stock, par value (in dollars per share) | $ 0.0001 | |||||||||||
Private Placement - First Closing | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Advisory fees to financial advisors | 1,800,000 | |||||||||||
Private Placement - Second Closing | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Consideration received | $ 50,000,000 | |||||||||||
Number of voting shares issued in connection with the issuance of warrants (in shares) | 1 | |||||||||||
Warrants fair value | $ 12,700,000 | |||||||||||
Advisory fees to financial advisors | 2,800,000 | |||||||||||
Minimum | First and Second Closing | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Consideration received | $ 28,200,000 | |||||||||||
Maximum | First and Second Closing | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Consideration received | $ 47,200,000 | |||||||||||
Common Stock | Private Placement - First Closing | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Price per share (in dollars per share) | 4.50 | |||||||||||
Stock option warrant to purchase, exercise price per share (in dollars per share) | $ 6.38 | |||||||||||
Warrants issued in connection with Agreement (in shares) | 6,666,667 | |||||||||||
Common stock issued upon the exercise of common stock warrants (in shares) | 1,666,667 | |||||||||||
Consideration received | $ 30,000,000 | |||||||||||
Term of warrants | 7 years | |||||||||||
Exercisable term | 6 months | |||||||||||
WIM Warrants | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Change in fair value of warrants | $ 1,400,000 | |||||||||||
WIM Warrants | Private Placement - Second Closing | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Warrants cancelable after Second Closing (in shares) | 475,000 | |||||||||||
Reload Warrants | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Stock option warrant to purchase, exercise price per share (in dollars per share) | $ 5.20 | |||||||||||
Common stock issued upon the exercise of common stock warrants (in shares) | 1,188,029 | |||||||||||
Warrants fair value | $ 2,500,000 | |||||||||||
Reload Warrants | Private Placement - Second Closing | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Warrants cancelable after Second Closing (in shares) | 1,188,029 | |||||||||||
PDL | Common Stock | Private Placement - Second Closing | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Warrants issued in connection with Agreement (in shares) | 6,666,667 | |||||||||||
PDL | Baker Second Closing Warrants | Private Placement - Second Closing | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Warrants issued in connection with Agreement (in shares) | 1,666,667 | |||||||||||
Invesco | Common Stock | Private Placement - Second Closing | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Warrants issued in connection with Agreement (in shares) | 2,222,222 | |||||||||||
Invesco | Baker Second Closing Warrants | Private Placement - Second Closing | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Warrants issued in connection with Agreement (in shares) | 555,556 | |||||||||||
WIM | Common Stock | Private Placement - Second Closing | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Warrants issued in connection with Agreement (in shares) | 2,222,223 | |||||||||||
WIM | Baker Second Closing Warrants | Private Placement - Second Closing | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Warrants issued in connection with Agreement (in shares) | 555,556 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) | Jun. 10, 2020USD ($)shares | Jun. 05, 2020USD ($)$ / sharesshares | Apr. 24, 2020 | Mar. 24, 2020$ / sharesshares | Jun. 10, 2019shares | Jun. 05, 2019USD ($) | Feb. 05, 2019USD ($)$ / sharesshares | Sep. 30, 2020USD ($)$ / sharesshares | Jun. 30, 2020USD ($) | Jun. 30, 2019USD ($)$ / sharesshares | Sep. 30, 2020USD ($)$ / sharesshares | Sep. 30, 2019USD ($) | Dec. 31, 2019USD ($)$ / sharesshares | Nov. 30, 2019USD ($) | Feb. 08, 2019$ / sharesshares | Jan. 17, 2018$ / sharesshares |
Class Of Stock [Line Items] | ||||||||||||||||
Common stock issued upon the exercise of common stock warrants (in shares) | 0.001 | |||||||||||||||
Stock option warrant to purchase, exercise price per share (in dollars per share) | $ / shares | $ 2.44 | $ 0.0175 | $ 4.54 | $ 4.54 | ||||||||||||
Proceeds from issuance of common stock - exercise of warrants | $ | $ 2,000 | $ 6,273,000 | ||||||||||||||
Change in fair value of warrants | $ | $ 3,300,000 | |||||||||||||||
Warrants outstanding (in shares) | 10,426,107 | 10,426,107 | ||||||||||||||
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) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | $ 0.0001 | ||||||||||||
Short-swing profit disgorgement | $ | $ 0 | $ 187,000 | $ 200,000 | |||||||||||||
Stock dividend, rights (in shares) | 1 | |||||||||||||||
Rights issued per share of common stock held (in shares) | $ / shares | $ 1 | |||||||||||||||
Vesting term for beneficial ownership threshold | 10 days | |||||||||||||||
Beneficial ownership threshold (percent) | 0.32 | |||||||||||||||
Vesting term | 5 years | 10 days | ||||||||||||||
Public Offering | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Number of shares issued (in shares) | 28,500,000 | |||||||||||||||
Price per share (in dollars per share) | $ / shares | $ 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] | ||||||||||||||||
Number of shares issued (in shares) | 3,200,000 | |||||||||||||||
Consideration received | $ | $ 10,500,000 | |||||||||||||||
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) | $ / shares | $ 0.0001 | |||||||||||||||
WIM Warrants | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Issuance of common stock upon cashless exercise of warrants (in shares) | 1,525,000 | |||||||||||||||
Change in fair value of warrants | $ | $ 1,400,000 | |||||||||||||||
Warrants canceled (in shares) | 475,000 | |||||||||||||||
Reload Warrants | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Common stock issued upon the exercise of common stock warrants (in shares) | 1,188,029 | |||||||||||||||
Stock option warrant to purchase, exercise price per share (in dollars per share) | $ / shares | $ 5.20 | |||||||||||||||
Warrants fair value | $ | $ 2,500,000 | |||||||||||||||
Warrants | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Proceeds from issuance of common stock - exercise of warrants | $ | $ 6,300,000 | |||||||||||||||
Security Purchase Agreement Warrants | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Common stock issued upon the exercise of common stock warrants (in shares) | 5,122,950 | 4,444,446 | 5,122,950 | |||||||||||||
Stock option warrant to purchase, exercise price per share (in dollars per share) | $ / shares | $ 2.44 | $ 6.38 | $ 2.44 | |||||||||||||
Certain Holders | Reload Warrants | ||||||||||||||||
Class Of Stock [Line Items] | ||||||||||||||||
Common stock issued upon the exercise of common stock warrants (in shares) | 851,062 | |||||||||||||||
Stock option warrant to purchase, exercise price per share (in dollars per share) | $ / shares | $ 2.64 | |||||||||||||||
Change in fair value of warrants | $ | $ 500,000 | |||||||||||||||
Piper Sandler Co. | At The Market (ATM) | ||||||||||||||||
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 | $ | $ 3,800,000 | |||||||||||||||
Other receivables | $ | $ 300,000 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Warrants (Details) - $ / shares | Sep. 30, 2020 | Jun. 09, 2020 | Jun. 05, 2020 | Apr. 24, 2020 | Mar. 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) | 10,426,107 | |||||||||||
Exercise Price (in dollars per share) | $ 4.54 | $ 2.44 | $ 0.0175 | |||||||||
Common Warrants | ||||||||||||
Class of Warrant or Right [Line Items] | ||||||||||||
Underlying Common Stock to be Purchased (in shares) | 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) | $ 2.44 | $ 2.44 | $ 6.38 | $ 6.38 | $ 7.50 | $ 7.50 | $ 3.69 | $ 51.24 | $ 51.24 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Common Stock Reserved for Future Issuance (Details) | Sep. 30, 2020shares |
Class Of Stock [Line Items] | |
Common stock issuable upon the exercise of common stock warrants (in shares) | 10,426,107 |
Total common stock reserved for future issuance (in shares) | 22,989,624 |
Options to Purchase Common Stock | |
Class Of Stock [Line Items] | |
Common stock issuable upon the exercise of stock options outstanding (in shares) | 8,972,112 |
Employee Stock Purchase Plan 2019 | |
Class Of Stock [Line Items] | |
Common stock available for future issuance under 2019 ESPP (in shares) | 1,354,968 |
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) | 1,752,262 |
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) | 484,175 |
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 | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total | $ 1,637 | $ 2,263 | $ 11,072 | $ 6,740 |
Research and development | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total | 291 | 202 | 1,689 | 859 |
Selling and marketing | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total | 347 | 564 | 2,006 | 1,101 |
General and administrative | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Total | $ 999 | $ 1,497 | $ 7,377 | $ 4,780 |
Stock-based Compensation - Addi
Stock-based Compensation - Additional Information (Details) - USD ($) | Apr. 01, 2020 | Apr. 01, 2019 | Sep. 30, 2012 | Sep. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | Feb. 25, 2020 | Jan. 01, 2020 | May 07, 2019 | Feb. 26, 2019 | Jan. 01, 2019 | Jul. 24, 2018 | Nov. 30, 2014 | Sep. 15, 2014 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||
Options granted (in shares) | 631,200 | 290,000 | 2,873,685 | 733,000 | |||||||||||||
Share-based compensation expense | $ 1,637,000 | $ 2,263,000 | $ 11,072,000 | $ 6,740,000 | |||||||||||||
Stock options | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||
Unrecognized stock-based compensation expense | 10,900,000 | $ 10,900,000 | |||||||||||||||
Recognition period for unrecognized share-based compensation expense | 2 years 4 months 24 days | ||||||||||||||||
Vested Restricted Stock Awards (RSA) | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||
Share-based compensation expense | $ 100,000 | $ 6,500,000 | |||||||||||||||
2012 Equity Incentive Plan | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||
Expiration period | 10 years | ||||||||||||||||
Amended and Restated 2014 Plan | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||
Number of shares authorized (in shares) | 11,725,515 | 7,800,000 | 749,305 | ||||||||||||||
Incremental number of shares authorized (in shares) | 2,000,000 | 1,925,515 | |||||||||||||||
Automatic shares authorized under plan increase, percentage of common stock issued and outstanding (percent) | 4.00% | ||||||||||||||||
Shares remain available for future grant (in shares) | 1,752,262 | 1,752,262 | |||||||||||||||
Number of shares granted out of the reserve increase (in shares) | 1,027,400 | ||||||||||||||||
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 | $ 300,000 | $ 300,000 | |||||||||||||||
Recognition period for unrecognized share-based compensation expense | 1 year 3 months 18 days | ||||||||||||||||
Inducement Plan | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||
Number of shares authorized (in shares) | 1,250,000 | 250,000 | |||||||||||||||
Shares remain available for future grant (in shares) | 484,175 | 484,175 | |||||||||||||||
Employee Stock Purchase Plan 2014 | ESPP | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||
Number of shares authorized (in shares) | 28,333 | ||||||||||||||||
Incremental number of shares authorized (in shares) | 258,672 | ||||||||||||||||
Employee Stock Purchase Plan 2019 | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||
Shares of common stock purchased under the ESPP (in shares) | 0 | 0 | 0 | ||||||||||||||
Common stock available for future issuance under 2019 ESPP (in shares) | 1,354,968 | 1,354,968 | |||||||||||||||
Employee Stock Purchase Plan 2019 | ESPP | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||
Incremental number of shares authorized (in shares) | 1,000,000 | 1,000,000 | |||||||||||||||
Automatic shares authorized under plan increase, percentage of common stock issued and outstanding (percent) | 2.00% | ||||||||||||||||
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 | |||||||||||||||
Vesting period one | 2012 Equity Incentive Plan | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||
Vesting period | 4 years | ||||||||||||||||
Percent exercisable | 25.00% | ||||||||||||||||
Vesting period two | 2012 Equity Incentive Plan | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||
Vesting period | 3 years | ||||||||||||||||
Percent exercisable | 25.00% | ||||||||||||||||
Executive Management Team and Certain Non-Executive Employees | Amended and Restated 2014 Plan | Restricted Stock Awards (RSA) | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||
Issued for the right to shares common stock (in shares) | 150,000 | 1,265,000 | 625,500 | ||||||||||||||
Executive Management Team and Certain Non-Executive Employees | Vesting period one | Amended and Restated 2014 Plan | Restricted Stock Awards (RSA) | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||
Issued for the right to shares common stock (in shares) | 1,245,000 | 460,500 | |||||||||||||||
Chairman | Amended and Restated 2014 Plan | Restricted Stock Units (RSUs) | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||
Vesting period | 1 year | ||||||||||||||||
Issued for the right to shares common stock (in shares) | 150,000 | 150,000 | |||||||||||||||
Minimum | Employee Stock Purchase Plan 2019 | ESPP | |||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||
Contribution limitations, percentage of employees salaries (percent) | 1.00% | ||||||||||||||||
Maximum | Employee Stock Purchase Plan 2019 | ESPP | |||||||||||||||||
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 | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Stock options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected volatility (percent) | 90.70% | 76.00% | 82.40% | 76.10% |
Risk-free interest rate (percent) | 0.40% | 1.50% | 0.60% | 1.90% |
Expected dividend yield (percent) | 0.00% | 0.00% | 0.00% | 0.00% |
Expected term (years) | 6 years 1 month 6 days | 6 years | 6 years | 5 years 10 months 24 days |
ESPP | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected volatility (percent) | 108.90% | 72.50% | 108.90% | 72.50% |
Risk-free interest rate (percent) | 0.20% | 2.20% | 0.20% | 2.20% |
Expected dividend yield (percent) | 0.00% | 0.00% | 0.00% | 0.00% |
Expected term (years) | 6 months | 6 months | 6 months | 6 months |
Subsequent Events (Details)
Subsequent Events (Details) - Senior Convertible Notes Payable - USD ($) | Oct. 14, 2020 | Apr. 24, 2020 | Apr. 23, 2020 |
Subsequent Event [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% | ||
Subsequent Event | |||
Subsequent Event [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% | ||
Conversion price (in dollars per share) | $ 3.65 | ||
Weighted average period | 30 days | ||
Weighted average price per share (in dollars per share) | $ 10 | ||
Debt covenant, cumulative net sales requirement | $ 100,000,000 |