Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2021 | Nov. 05, 2021 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Sep. 30, 2021 | |
Entity File Number | 001-37717 | |
Entity Registrant Name | SENSEONICS HOLDINGS, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 47-1210911 | |
Entity Address, Address Line One | 20451 Seneca Meadows Parkway | |
Entity Address, City or Town | Germantown | |
Entity Address, State or Province | MD | |
Entity Address, Postal Zip Code | 20876-7005 | |
City Area Code | 301 | |
Local Phone Number | 515-7260 | |
Title of 12(b) Security | Common Stock, $0.001 par value | |
Trading Symbol | SENS | |
Security Exchange Name | NYSEAMER | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 445,982,671 | |
Entity Central Index Key | 0001616543 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 46,211 | $ 18,005 |
Restricted cash | 200 | |
Short term investments, net | 96,566 | |
Accounts receivable, net | 124 | 565 |
Accounts receivable - related parties | 3,549 | 2,421 |
Inventory, net | 7,878 | 5,281 |
Prepaid expenses and other current assets | 3,732 | 3,774 |
Total current assets | 158,060 | 30,246 |
Option | 236 | 1,886 |
Deposits and other assets | 1,668 | 2,229 |
Long term investments, net | 58,355 | |
Property and equipment, net | 1,305 | 1,557 |
Total assets | 219,624 | 35,918 |
Current liabilities: | ||
Accounts payable | 793 | 1,762 |
Accrued expenses and other current liabilities | 13,985 | 11,674 |
Term Loans, net | 5,113 | 3,202 |
Total current liabilities | 19,891 | 16,638 |
Long-term debt and notes payables, net | 57,161 | 57,216 |
Derivative liabilities | 317,304 | 62,119 |
Option | 91,097 | 39,734 |
Other liabilities | 817 | 1,483 |
Total liabilities | 486,270 | 177,190 |
Preferred stock and additional paid-in-capital, subject to possible redemption: $0.001 par value per share; 0 shares issued and outstanding as of September 30, 2021 and 3,000 shares issued and outstanding as of December 31, 2020 | 2,811 | |
Total temporary equity | 2,811 | |
Commitments and contingencies | ||
Stockholders' deficit: | ||
Common stock, $0.001 par value per share; 900,000,000 shares authorized; 445,615,196 and 265,582,688 shares issued and outstanding as of September 30, 2021 and December 31, 2020 | 446 | 266 |
Additional paid-in capital | 768,324 | 504,162 |
Accumulated other comprehensive income, net of tax | 2 | |
Accumulated deficit | (1,035,418) | (648,511) |
Total stockholders' deficit | (266,646) | (144,083) |
Total liabilities and stockholders' deficit | $ 219,624 | $ 35,918 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parentheticals) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
Class of stock information | ||
Temporary equity, par or stated value per share | $ 0.001 | $ 0.001 |
Temporary equity, shares issued | 0 | 3,000 |
Temporary equity, shares outstanding | 0 | 3,000 |
Common stock, par value per share (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 900,000,000 | 900,000,000 |
Common stock, shares issued | 445,615,196 | 265,582,688 |
Common stock, shares outstanding | 445,615,196 | 265,582,688 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) | ||||
Revenue, net | $ 276 | $ 514 | $ 1,196 | $ 761 |
Revenue, net - related parties | 3,256 | 253 | 8,471 | 303 |
Total revenue | 3,532 | 767 | 9,667 | 1,064 |
Cost of sales | 4,778 | (68) | 9,995 | 21,006 |
Gross profit (loss) | (1,246) | 835 | (328) | (19,942) |
Expenses: | ||||
Sales and marketing expenses | 2,468 | 3,234 | 5,725 | 17,521 |
Research and development expenses | 7,200 | 4,568 | 19,562 | 15,726 |
General and administrative expenses | 5,117 | 5,501 | 17,622 | 15,635 |
Operating loss | (16,031) | (12,468) | (43,237) | (68,824) |
Other income (expense), net: | ||||
Interest income | 486 | 1 | 743 | 173 |
Gain (Loss) on fair value adjustment of option | 13,556 | (74,848) | ||
Gain (Loss) on extinguishment of debt and option | (9,527) | 330 | (20,458) | |
Loss on issuance of debt & other issuance costs | (931) | (1,216) | ||
Interest expense | (4,245) | (3,632) | (12,337) | (11,560) |
Gain (Loss) on change in fair value of derivatives | 50,075 | 3,520 | (255,185) | 29,069 |
Impairment cost | (488) | (1,650) | ||
Other expense | (439) | (391) | (723) | (720) |
Total other income (expense), net | 58,945 | (10,960) | (343,670) | (4,712) |
Net Income (Loss) | 42,914 | (23,428) | (386,907) | (73,536) |
Other comprehensive income, net of tax | ||||
Unrealized gain on marketable securities | 18 | 2 | ||
Total other comprehensive income, net of tax | 18 | 2 | ||
Total comprehensive income (loss), net of tax | $ 42,932 | $ (23,428) | $ (386,905) | $ (73,536) |
Basic net income (loss) per common share | $ 0.10 | $ (0.10) | $ (0.93) | $ (0.33) |
Basic weighted-average shares outstanding | 445,378,308 | 236,519,812 | 414,128,283 | 220,250,060 |
Diluted net income (loss) per common share | $ 0.08 | $ (0.10) | $ (0.93) | $ (0.33) |
Diluted weighted-average shares outstanding | 581,760,516 | 236,519,812 | 414,128,283 | 220,250,060 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit) - USD ($) shares in Thousands, $ in Thousands | Common Stock | Additional Paid-In Capital | AOCI Attributable to Parent [Member] | Accumulated Deficit | Series A Preferred Stock | Total |
Balance at Dec. 31, 2019 | $ 203 | $ 464,491 | $ (473,343) | $ (8,649) | ||
Balance (in shares) at Dec. 31, 2019 | 203,453 | |||||
Changes in Stockholders' Equity (Deficit) | ||||||
Issuance of common stock, net | (86) | (86) | ||||
Issuance of common stock (in shares) | 175 | |||||
Exercise of stock options and ESPP purchases | $ 2 | 573 | 575 | |||
Exercise of stock options and ESPP purchases (in shares) | 2,220 | |||||
Exchange and conversion of convertible notes, net | $ 39 | 20,082 | 20,121 | |||
Exchange and conversion of convertible notes, net (in shares) | 38,391 | |||||
Stock-based compensation expense and vesting of RSUs | 5,581 | 5,581 | ||||
Issuance of warrants related to debt, net | 1,212 | 1,212 | ||||
Net income (loss) | (73,536) | (73,536) | ||||
Balance at Sep. 30, 2020 | $ 244 | 491,853 | (546,879) | (54,782) | ||
Balance (in shares) at Sep. 30, 2020 | 244,239 | |||||
Balance at Dec. 31, 2019 | $ 203 | 464,491 | (473,343) | (8,649) | ||
Balance (in shares) at Dec. 31, 2019 | 203,453 | |||||
Changes in Stockholders' Equity (Deficit) | ||||||
Net income (loss) | (175,200) | |||||
Balance at Dec. 31, 2020 | $ 266 | 504,162 | (648,511) | (144,083) | ||
Balance (in shares) at Dec. 31, 2020 | 265,582 | |||||
Temporary Equity, Ending Balance at Dec. 31, 2020 | $ 2,811 | |||||
Balance at Jun. 30, 2020 | $ 231 | 483,615 | (523,451) | (39,605) | ||
Balance (in shares) at Jun. 30, 2020 | 230,553 | |||||
Changes in Stockholders' Equity (Deficit) | ||||||
Exercise of stock options and ESPP purchases | $ 1 | 76 | 77 | |||
Exercise of stock options and ESPP purchases (in shares) | 1,188 | |||||
Exchange and conversion of convertible notes, net | $ 12 | 5,859 | 5,871 | |||
Exchange and conversion of convertible notes, net (in shares) | 12,498 | |||||
Stock-based compensation expense and vesting of RSUs | 2,303 | 2,303 | ||||
Net income (loss) | (23,428) | (23,428) | ||||
Balance at Sep. 30, 2020 | $ 244 | 491,853 | (546,879) | (54,782) | ||
Balance (in shares) at Sep. 30, 2020 | 244,239 | |||||
Balance at Dec. 31, 2020 | $ 266 | 504,162 | (648,511) | (144,083) | ||
Balance (in shares) at Dec. 31, 2020 | 265,582 | |||||
Changes in Stockholders' Equity (Deficit) | ||||||
Conversion of preferred stock | $ 54 | 45,512 | 45,566 | |||
Conversion of preferred stock (in shares) | 54,166 | |||||
Issuance of common stock, net | $ 113 | 200,327 | 200,440 | |||
Issuance of common stock (in shares) | 112,571 | |||||
Exercise of stock options and warrants | $ 5 | 4,622 | 4,627 | |||
Exercise of stock options and warrants (in shares) | 5,501 | |||||
Exchange and conversion of convertible notes, net | $ 5 | 6,496 | 6,501 | |||
Exchange and conversion of convertible notes, net (in shares) | 4,925 | |||||
Issued common stock for vested RSUs and ESPP purchase | $ 3 | 71 | 74 | |||
Issued common stock for vested RSUs and ESPP purchase (in shares) | 2,870 | |||||
Stock-based compensation expense | 7,134 | 7,134 | ||||
Net income (loss) | (386,907) | (386,907) | ||||
Other comprehensive income, net of tax | $ 2 | 2 | ||||
Balance at Sep. 30, 2021 | $ 446 | 768,324 | 2 | (1,035,418) | (266,646) | |
Balance (in shares) at Sep. 30, 2021 | 445,615 | |||||
Increase (Decrease) in Temporary Equity | ||||||
Issuance of convertible preferred stock, net | 42,756 | |||||
Conversion of preferred stock | $ (45,567) | |||||
Balance at Jun. 30, 2021 | $ 445 | 765,262 | (16) | (1,078,332) | (312,641) | |
Balance (in shares) at Jun. 30, 2021 | 445,125 | |||||
Changes in Stockholders' Equity (Deficit) | ||||||
Exercise of stock options and warrants | $ 1 | 737 | 738 | |||
Exercise of stock options and warrants (in shares) | 474 | |||||
Issued common stock for vested RSUs and ESPP purchase | 24 | 24 | ||||
Issued common stock for vested RSUs and ESPP purchase (in shares) | 16 | |||||
Stock-based compensation expense | 2,301 | 2,301 | ||||
Net income (loss) | 42,914 | 42,914 | ||||
Other comprehensive income, net of tax | 18 | 18 | ||||
Balance at Sep. 30, 2021 | $ 446 | $ 768,324 | $ 2 | $ (1,035,418) | $ (266,646) | |
Balance (in shares) at Sep. 30, 2021 | 445,615 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Cash flows from operating activities | ||
Net loss | $ (386,907) | $ (73,536) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization expense | 918 | 853 |
Non-cash interest expense (debt discount and deferred costs) | 5,825 | 7,200 |
Change in fair value of derivatives | 255,185 | (29,069) |
Loss on fair value adjustment of option | 74,848 | |
(Gain) Loss on extinguishment of debt and option | (330) | 20,458 |
Impairment cost | 1,650 | |
Stock-based compensation expense | 7,134 | 5,581 |
Loss on disposal of assets | 181 | |
Changes in assets and liabilities: | ||
Accounts receivable | (686) | 9,880 |
Prepaid expenses and other current assets | 41 | (77) |
Inventory | (2,597) | 12,645 |
Deposits and other assets | (30) | 117 |
Accounts payable | (971) | (3,336) |
Accrued expenses and other liabilities | 1,319 | (8,608) |
Accrued interest | 326 | (877) |
Operating lease liabilities | (586) | |
Net cash used in operating activities | (44,275) | (59,174) |
Cash flows from investing activities | ||
Capital expenditures | (75) | (181) |
Purchase of marketable securities | (154,918) | |
Net cash used in investing activities | (154,993) | (181) |
Cash flows from financing activities | ||
Issuance of common stock, net | 200,440 | (87) |
Proceeds from exercise of stock options, stock warrants and ESPP purchases | 4,701 | 576 |
Proceeds from debt issuance, net | 55,971 | |
Proceeds from issuance of Masters preferred stock, net | 22,783 | |
Repayment of term loans | (650) | (66,050) |
Cost of issuance of Second Lien Notes | (601) | |
Net cash provided by (used in) financing activities | 227,274 | (10,191) |
Net increase (decrease) in cash, cash equivalents and restricted cash | 28,006 | (69,546) |
Cash, cash equivalents and restricted cash, at beginning of period | 18,205 | 95,938 |
Cash, cash equivalents and restricted cash, at ending of period | 46,211 | 26,392 |
Supplemental disclosure of cash flow information | ||
Cash paid during the period for interest | $ 6,149 | 5,600 |
Supplemental disclosure of non-cash investing and financing activities | ||
Issuance of common stock converted from notes payables | 300 | |
Exchange of 2025 Notes for Second Lien Notes | (24,000) | |
Issuance of Second Lien Notes | $ 15,675 |
Organization and Nature of Oper
Organization and Nature of Operations | 9 Months Ended |
Sep. 30, 2021 | |
Organization and Nature of Operations | |
Organization and Nature of Operations | 1. Organization and Nature of Operations Senseonics Holdings, Inc., a Delaware corporation, is a medical technology company focused on the development and commercialization of long-term, implantable continuous glucose monitoring (“CGM”) systems to improve the lives of people with diabetes by enhancing their ability to manage their disease with relative ease and accuracy. Senseonics, Incorporated is a wholly owned subsidiary of Senseonics Holdings and was originally incorporated on October 30, 1996 and commenced operations on January 15, 1997. Senseonics Holdings and Senseonics, Incorporated are hereinafter collectively referred to as the “Company” unless otherwise indicated or the context otherwise requires. |
Liquidity and Capital Resources
Liquidity and Capital Resources | 9 Months Ended |
Sep. 30, 2021 | |
Liquidity and Capital Resources | |
Liquidity and Capital Resources | 2. Liquidity and Capital Resources From its founding in 1996 until 2010, the Company has devoted substantially all of its resources to researching various sensor technologies and platforms. Beginning in 2010, the Company narrowed its focus to developing and refining a commercially viable glucose monitoring system. However, to date, the Company has not generated any significant revenue from product sales. The Company has incurred substantial losses and cumulative negative cash flows from operations since its inception in October 1996. The Company has never been profitable from operations, and its net losses were $175.2 million, $115.5 million, and $94.0 million for the years ended December 31, 2020, 2019 and 2018, respectively. As of September 30, 2021, the Company had an accumulated deficit of $1.0 billion. To date, the Company has funded its operations principally through the issuance of preferred stock, common stock, convertible note issuance and debt. As of September 30, 2021, the Company had cash, cash equivalents and marketable securities of $201.1 million. In November 2019, the Company entered into an Open Market Sale Agreement with Jefferies LLC, under which the Company could offer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $50.0 million through Jeffries as its sales agent in an “at the market” offering. In June 2021, the Company received $48.4 million in net proceeds from the sale of 12,830,333 shares of its common stock utilizing the full capacity under the 2019 Sales Agreement. For the nine months ended September 30, 2020, the Company had received $0.1 million in net proceeds from the sale of 175,289 shares of its common stock under the 2019 Sales Agreement. On January 21, 2021, the Company entered into an underwriting agreement, which was subsequently amended and restated on the same day (the “Underwriting Agreement”) with H.C. Wainwright & Co., LLC, as representative of the underwriters (the “Underwriters”), to issue and sell 51,948,052 shares of common stock, in an underwritten public offering pursuant to effective registration statements on Form S-3, including a related prospectus and prospectus supplement, in each case filed with the Securities and Exchange Commission (the “Offering”). The price to the public in the Offering was $1.925 per share of common stock. The Underwriters agreed to purchase the shares from the Company pursuant to the Underwriting Agreement at a price of $1.799875 per share and the Company also agreed to reimburse them for customary fees and expenses. The initial closing of the Offering occurred on January 26, 2021. Subsequent to the initial closing, the Underwriters exercised their option to purchase an additional 7,792,207 shares of common stock. Total net proceeds from the Offering were $106.1 million after deducting underwriting discounts and commissions and estimated offering expenses. On January 17, 2021, the Company entered into a Securities Purchase Agreement (the “Purchase Agreement”) with certain institutional purchasers (the “Purchasers”), pursuant to which the Company sold to the Purchasers, in a registered direct offering (the “Registered Direct Offering”), an aggregate of 40,000,000 shares (the “Shares”) of common stock, $0.001 par value per share. The Shares were sold at a purchase price of $1.25 per share for aggregate gross proceeds to the Company of $50.0 million, before deducting fees to the placement agent and other estimated offering expenses payable by the Company. The Shares were offered and sold by the Company pursuant to an effective shelf registration statement on Form S-3, which was originally filed with the Securities and Exchange Commission on November 27, 2019. The net proceeds to the Company from the Registered Direct Offering, after deducting fees and expenses and the estimated offering expenses payable by the Company, are approximately $46.1 million. On November 9, 2020, the Company entered into an equity line agreement (the “Equity Line Agreement”) with Energy Capital, LLC, a Florida limited liability company (“Energy Capital”), which provides that, upon the terms and subject to the conditions and limitations set forth therein, Energy Capital is committed to purchase up to an aggregate of $12.0 million of shares of the Company’s newly designated series B convertible preferred stock (the “Series B Preferred Stock”) at the Company’s request from time to time during the 24-month term of the Equity Line Agreement. Under the Equity Line Agreement, beginning January 21, 2021, subject to the satisfaction of certain conditions, including the Company has less than $8 million of cash, cash equivalents and other available credit (aside from availability under the Equity Line Agreement), the Company has the right, at its sole discretion, to present Energy Capital with a purchase notice (each, a “Regular Purchase Notice”) directing Energy Capital (as principal) to purchase shares of Series B Preferred Stock at a price of $1,000 per share (not to exceed $4.0 million worth of shares) once per month, up to an aggregate of $12.0 million of our Series B Preferred Stock at a per share price (the “Purchase Price”) equal to $1,000 per share of Series B Preferred Stock, with each share of Series B Preferred Stock initially convertible into common stock, beginning six months after the date of its issuance, at a conversion price of $0.3951 per share, subject to customary anti-dilution adjustments, including in the event of any stock split. The Equity Line Agreement provides that the Company shall not affect any Regular Purchase under the Equity Line Agreement on any date where the closing price of the Company’s common stock on the NYSE American is less than $0.25 without the approval of Energy Capital. In addition, beginning on January 1, 2022, subject to the satisfaction of certain conditions, if the full $12.0 million of Series B Preferred Stock has not been sold pursuant to Regular Purchases, Energy Capital may, at its sole discretion, by its delivery to the Company of a Purchase Notice, from time to time, purchase up to the amount then remaining available under the Equity Line Agreement at the Purchase Price. On August 9, 2020, the Company entered into a financing agreement with the parent company of Ascensia Diabetes Care Holdings AG (“Ascensia”), PHC Holdings Corporation (“PHC”), pursuant to which the Company issued $35.0 million in aggregate principal amount of Senior Secured Convertible Notes due on October 31, 2024 (the “PHC Notes”), to PHC. The Company also issued 2,941,176 shares of common stock to PHC as a financing fee. The Company also has the option to sell and issue PHC up to $15.0 million of convertible preferred stock on or before December 31, 2022, contingent upon obtaining approval for the 180-day Eversense product for marketing in the United States before such date. Additionally, on August 9, 2020, the Company entered into a Stock Purchase Agreement with Masters Special Solutions, LLC and certain affiliates thereof (“Masters”), pursuant to which the Company issued and sold to Masters 3,000 shares of convertible preferred stock, designated as “Series A Preferred Stock” (the “Series A Preferred Stock”), at a price of $1,000.00 per share in an initial closing. Masters also had the option to purchase up to an additional 27,000 shares of Series A Preferred Stock at a price of $1,000.00 per share in subsequent closings, subject to the terms and conditions of the Stock Purchase Agreement, as amended, through January 11, 2021. In January 2021, Masters and its assignees purchased in aggregate an additional 22,783 shares of Series A Preferred Stock, resulting in additional gross proceeds to the Company of $22.8 million. Each share of Series A Preferred Stock was initially convertible into a number of shares of common stock equal to $1,000.00 divided by the conversion price of $0.476 per share, subject to customary anti-dilution adjustments, including in the event of any stock split. All shares of Series A Preferred Stock have been converted to common stock as of September 30, 2021. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2021 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 3. Summary of Significant Accounting Policies Basis of Presentation The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. Although the Company considers the disclosures in these unaudited consolidated financial statements to be adequate to make the information presented not misleading, certain information or footnote information normally included in consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted as permitted under the rules and regulations of the United States Securities and Exchange Commission (“SEC”). In the opinion of management, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair statement of financial position at September 30, 2021, and December 31, 2020, results of operations, comprehensive income (loss), and changes in stockholder’s equity (deficit) for the three and nine months ended September 30, 2021, and 2020 and cash flows for the nine months ended September 30, 2021, and 2020 have been included. The unaudited condensed consolidated financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the SEC on March 5, 2021. The interim results for September 30, 2021, are not necessarily indicative of the results to be expected for the year ending December 31, 2021, or for any future interim periods. The consolidated financial statements reflect the accounts of Senseonics Holdings, Inc. and its wholly owned operating subsidiary Senseonics Incorporated. Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenue and expenses during the reporting period. In the accompanying unaudited consolidated financial statements, estimates are used for, but not limited to, stock-based compensation, recoverability of long-lived assets, deferred taxes and valuation allowances, derivative assets and liabilities, obsolete inventory, warranty obligations, variable consideration related to revenue, depreciable lives of property and equipment, and accruals for clinical study costs, which are accrued based on estimates of work performed under contract. The Company considered COVID-19 related impacts to its estimates, as appropriate, within its unaudited condensed consolidated financial statements and there may be changes to those estimates in future periods due to the uncertainties surrounding the severity and duration of the COVID-19 pandemic. Actual results could differ from those estimates; however, management does not believe that such differences would be material. Segment Information The Company views its operations and manages its business in one segment, glucose monitoring products. Comprehensive Loss Comprehensive income (loss) comprises net income (loss) and other changes in equity that are excluded from net income (loss). For the three and nine months ended September 30, 2021, the Company’s comprehensive income (loss) included less than $0.1 million of other comprehensive income related to the unrealized gain on marketable securities. For the three and nine months ended September 30, 2020, the Company’s net loss equaled its comprehensive loss and, accordingly, no additional disclosure is presented. Cash and Cash Equivalents The Company considers highly liquid investments with original maturities of three months or less from the date of purchase to be cash equivalents. These investments are carried at cost, which approximates fair value. Cash and cash equivalents consisted of the following as of the periods listed below (in thousands): September 30, December 31, 2021 2020 Cash ⁽ ¹ ⁾ $ 2,393 $ 18,002 Money market funds 43,818 3 Cash and cash equivalents $ 46,211 $ 18,005 (1) Includes overnight repurchase agreements Restricted Cash The Company’s restricted cash previously included pledged cash as collateral related to its credit card program with Silicon Valley Bank (“SVB”). The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same such amounts shown in the statement of cash flows (in thousands): September 30, December 31, 2021 2020 Cash and cash equivalents $ 46,211 $ 18,005 Restricted cash — 200 Cash, cash equivalents and restricted cash $ 46,211 $ 18,205 Long-lived Assets Management reviews long-lived assets, including property and equipment and right-of-use assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of the long-lived asset is measured by a comparison of the carrying amount of the asset to future undiscounted net cash flows expected to be generated by the asset. If the undiscounted cash flows are less than the carrying amount, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the estimated fair value of the assets. Management identified an indicator of impairment for a right of use asset and recorded an immaterial expense for the nine months ended September 30, 2021. There was no impairment recorded for the three months ended September 30, 2021. Warranty Obligation The Company provides a warranty of one year on its smart transmitters. Additionally, the Company may also replace Eversense system components that do not function in accordance with the product specifications. Estimated replacement costs are recorded at the time of shipment as a charge to cost of sales in the consolidated statement of operations and are developed by analyzing product performance data and historical replacement experience, including comparing actual replacements to revenue. At September 30, 2021, and December 31, 2020, the warranty reserve for both periods was $0.6 million. The following table provides a reconciliation of the change in estimated warranty liabilities for the nine months ended September 30, 2021 and for the twelve months ended December 31, 2020 (in thousands): September 30, December 31, 2021 2020 Balance at beginning of the period $ 646 $ 2,197 Provision for warranties during the period 760 (266) Settlements made during the period (844) (1,285) Balance at end of the period $ 562 $ 646 Revenue The Company recognizes revenue in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The Company generates revenue from sales of its Eversense CGM system and related components at a fixed price to third-party distributors in the European Union and to strategic fulfillment partners in the United States, and a combination of fixed and variable prices to its strategic partner, Ascensia (collectively, “Customers”), who then resell the products to health care providers and patients. The Company is paid for its sales directly to the Customers, regardless of whether or not the Customers resell the products to health care providers and patients. Customer contracts do not include the right to return unless there is a product issue, in which case the Company may provide replacement product. Product conformity guarantees do not create additional performance obligations and are accounted for as warranty obligations in accordance with guarantee and loss contingency accounting guidance. Revenue is recognized, at a point in time, when the Customers obtain control of the product based upon the delivery terms as defined in the contract, at an amount that reflects the consideration which is expected to be received in exchange for the product. Contracts with the Customers include performance obligations for supply of goods and the performance obligation is typically satisfied upon transfer of control of the product. Distribution contracts may also contain requirements for training and customer service support; however, these are not assessed as performance obligations given the activities are considered immaterial in the context of the contract. The payment terms and conditions of the Customers vary, but the Company is typically paid within 60 days of invoicing subsequent to the Customers obtaining control of the Company’s product. The Company’s contracts contain variable consideration such as prompt-pay discounts, tier-volume price discounts and for the Ascensia commercial agreement, revenue share. Variable consideration, such as discounts and prompt-pay incentives, are treated as a reduction in revenue and variable consideration, such as revenue share is treated as an addition in revenue when the product sale is recognized. The amount of variable consideration that is included in the transaction price may be constrained and is included in revenue only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period, when the uncertainty associated with the variable consideration is subsequently resolved. Estimating variable consideration and the related constraint requires the use of significant management judgement. Depending on the variable consideration, the Company estimates the expected value based on the terms of the agreements, historical data, geographic mix, reimbursement rates, and market conditions. The Company’s estimates used in determining the variable consideration on a sale transaction may be adjusted each reporting period depending on actual results, provided a change does not reflect a modification to the original contract. Contract assets consist of trade receivables and unbilled receivables from customers and are recorded at net realizable value. Unbilled receivables relate to the revenue share variable consideration from the Ascensia commercial agreement. Concentration of Revenue and Customers For the three months ended September 30, 2021, the Company derived 92% of its total revenue from one customer, Ascensia. For the three months ended September 30, 2020, the Company derived 33% of its total revenue from one customer, Roche Diabetes Care GmbH. For the nine months ended September 30, 2021, the Company derived 88% of its total revenue from one customer, Ascensia. For the nine months ended September 30, 2020, the Company derived 29% of its total revenue from one customer, Roche Diabetes Care GmbH. Revenues for these corresponding periods represent purchases for sensors, transmitters and miscellaneous Eversense system components. Revenue by Geographic Region The following table sets forth net revenue derived from the Company’s two primary geographical markets, the United States and outside of the United States, based on the geographic location to which the Company delivers the product, for the three and nine months ended September 30, 2021 and 2020: Three Months Ended Nine Months Ended September 30, 2021 September 30, 2021 % % (Dollars in thousands) Amount of Total Amount of Total Revenue, net: Outside of the United States $ 2,928 82.9 % $ 7,771 80.4 % United States 604 17.1 1,896 19.6 Total $ 3,532 100.0 % $ 9,667 100.0 % Three Months Ended Nine Months Ended September 30, 2020 September 30, 2020 % % (Dollars in thousands) Amount of Total Amount of Total Revenue, net: Outside of the United States $ 258 33.6 % $ 325 30.5 % United States 509 66.4 739 69.5 Total $ 767 100.0 % $ 1,064 100.0 % Marketable Securities Marketable securities consist of commercial paper, corporate debt securities, asset backed securities and government and agency securities. The Company’s investments are classified as available for sale. Such securities are carried at fair value, with any unrealized holding gains or losses reported, net of any tax effects reported, as accumulated other comprehensive income. Realized gains and losses and declines in value judged to be other-than-temporary, if any, are included in consolidated results of operations. A decline in the market value of any available for sale security below cost that is deemed to be other-than-temporary results in a reduction in fair value, which is charged to earnings in that period, and a new cost basis for the security is established. Dividend and interest income is recognized when earned. The cost of securities sold is calculated using the specific identification method. The Company classifies all available-for-sale marketable securities with maturities greater than one year from the balance sheet date as non-current assets. Accounts Receivable Accounts receivable consist of amounts due from the Company’s Customers and are recorded at net realizable value, which may include reductions for allowances for doubtful accounts at the time potential collection risk is identified or for promotional or prompt-pay discounts offered. The Company does not have a history of collectability concerns and no allowance for uncollectible accounts was recorded as of September 30, 2021, however, an immaterial allowance for uncollectible accounts was recorded as of December 31, 2020. Accounts receivable as of September 30, 2021 included unbilled accounts receivable of $2.0 million. The Company expects to invoice and collect all unbilled accounts receivable within 12 months. Net Income (Loss) per Share Basic net income per share attributable to common stockholders is calculated by dividing the net income attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net income per share is computed using the weighted average number of common shares outstanding during the period and, when dilutive, potential common share equivalents. Basic net loss per share is computed by dividing net loss available to common stockholders by the weighted average number of shares of common stock outstanding during the period. Potentially dilutive common shares consist of shares issuable from restricted stock units, warrants, and our convertible notes. Potentially dilutive common shares issuable upon vesting of restricted stock units and exercise of stock options and warrants are determined using the average share price for each period under the treasury stock method. Potentially dilutive common shares issuable upon conversion of our convertible notes are determined using the if converted method. In periods of net loss, all potentially dilutive common shares are excluded from the computation of the diluted net loss per share for those periods, as the effect would be anti-dilutive. The following table sets forth the computation of basic and diluted net income per share for the periods shown: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Net income (loss) 42,914 (23,428) (386,907) (73,536) Impact of conversion of dilutive securities 1,385 - - - Dilutive Net income (loss) 44,299 (23,428) (386,907) (73,536) Net income (loss) per share Basic 0.10 (0.10) (0.93) (0.33) Diluted 0.08 (0.10) (0.93) (0.33) Basic weighted average shares outstanding 445,378,308 236,519,812 414,128,283 220,250,060 Dilutive potential common stock outstanding Stock-based awards 15,520,414 - - - 2023 Notes 4,617,646 - - - 2025 Notes 39,689,142 - - - PHC Notes 65,348,857 - - - Warrants 11,206,148 - - - Diluted weighted average shares outstanding 581,760,516 236,519,812 414,128,283 220,250,060 For the nine months ended September 30, 2021, as well as for the three and nine months ended September 30, 2020, the Company operated at a loss. Accordingly, all potentially dilutive shares were considered antidilutive, and basic and diluted EPS are the same. Outstanding anti-dilutive securities not included in the diluted net income per share attributable to common stockholders calculations were as follows: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Stock-based awards 1,949,958 27,972,959 28,502,846 27,972,959 2023 Notes — 6,672,500 4,617,646 6,672,500 2025 Notes — 44,429,624 39,689,142 44,429,624 PHC Notes — 65,359,000 65,757,177 65,359,000 Second Lien Notes — 18,085,140 — 18,085,140 Warrants 116,581 9,696,581 13,177,822 9,696,581 Total anti-dilutive shares outstanding 2,066,539 172,215,804 151,744,633 172,215,804 Exit or Disposal Costs Costs associated with exit or disposal activities, such as restructuring, sale or termination of a line of business, the closure of business activities in a particular location, the relocation of business activities, changes in management structure and a fundamental reorganization that affects the nature and focus of operations, are recognized and measured initially at their fair values during the period in which an obligation meets the definition of a liability. There were no exit or disposal activities for the three and nine months ended September 30, 2021. The Company’s workforce reduction on March 26, 2020 did not permit continuation of service past March 31, 2020 and associated one-time employee termination benefit costs in the amount of $1.4 million were paid and recorded in the Company’s accompanying unaudited consolidated financial statements for the nine months ended September 30, 2020. Recent Accounting Pronouncements Recently Adopted In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes Not Yet Adopted In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses: Measurement of Credit Losses on Financial Instruments In August 2020, the FASB issued ASU 2020-06, Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contract in Entity’s Own Equity (Subtopic 815-40). |
Marketable Securities
Marketable Securities | 9 Months Ended |
Sep. 30, 2021 | |
Marketable Securities | |
Marketable Securities | 4. Marketable Securities Marketable securities available for sale, were as follows (in thousands): September 30, 2021 Gross Gross Estimated Amortized Unrealized Unrealized Market Cost Gains Losses Value Commercial Paper $ 62,336 — — $ 62,336 Corporate debt securities $ 40,084 5 (4) $ 40,085 Asset backed securities $ 27,869 5 (4) $ 27,870 Government and agency securities $ 24,630 5 (5) $ 24,630 Total $ 154,919 $ 15 $ (13) $ 154,921 The following are the scheduled maturities as of September 30, 2021 (in thousands): 2021 (remaining three months) $ 4,999 2022 149,922 2023 — 2024 — Thereafter — Total $ 154,921 |
Inventory, net
Inventory, net | 9 Months Ended |
Sep. 30, 2021 | |
Inventory, net | |
Inventory, net | 5. Inventory, net Inventory, net of reserves, consisted of the following (in thousands): September 30, December 31, 2021 2020 Finished goods $ 1,927 $ 203 Work-in-process 4,513 2,626 Raw materials 1,438 2,452 Total $ 7,878 $ 5,281 The Company charged $1.8 million to cost of sales for the nine months ended September 30, 2021 and $15.1 million to cost of sales for the nine months ended September 30, 2020, to reduce the value of inventory for items that are potentially obsolete due to expiry, in excess of product demand, or to adjust costs to their net realizable value . |
Prepaid Expenses and Other Curr
Prepaid Expenses and Other Current Assets | 9 Months Ended |
Sep. 30, 2021 | |
Prepaid Expenses and Other Current Assets | |
Prepaid Expenses and Other Current Assets | 6. Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): September 30, December 31, 2021 2020 Contract manufacturing⁽¹⁾ $ 2,431 $ 3,324 Interest receivable 378 — Insurance 266 50 IT and software 266 150 Research and development 115 — Rent 105 102 Other 171 148 Total prepaid expenses and other current assets $ 3,732 $ 3,774 (1) Includes deposits to contract manufacturers for manufacturing process . |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 9 Months Ended |
Sep. 30, 2021 | |
Accrued Expenses and Other Current Liabilities | |
Accrued Expenses and Other Current Liabilities | 7. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): September 30, December 31, 2021 2020 Compensation and benefits $ 3,010 $ 4,344 Interest on notes payable 2,098 1,773 Professional and administration services 1,945 880 Product warranty and replacement obligations 1,783 646 Contract manufacturing 1,629 1,421 Research and development 1,454 842 Sales and marketing services 1,149 615 Operating lease 875 794 Other 42 151 Patient access programs — 208 Total accrued expenses and other current liabilities $ 13,985 $ 11,674 |
Notes Payable, Preferred Stock
Notes Payable, Preferred Stock and Stock Purchase Warrants | 9 Months Ended |
Sep. 30, 2021 | |
Notes Payable, Preferred Stock and Stock Purchase Warrants | |
Notes Payable, Preferred Stock and Stock Purchase Warrants | 8. Notes Payable, Preferred Stock and Stock Purchase Warrants Term Loans PPP Loan On April 22, 2020, the Company received $5.8 million in loan funding from the PPP pursuant to the CARES Act, as amended by the Flexibility Act, and administered by the Small Business Administration (“SBA”). The unsecured loan (the “PPP Loan”) is evidenced by the PPP Note dated April 21, 2020 (the “PPP Note”) in the principal amount of $5.8 million with SVB. Under the terms of the PPP Note and the PPP Loan, interest accrues on the outstanding principal at a rate of 1.0% per annum. The term of the PPP Note is two years , though it may be payable sooner in connection with an event of default under the PPP Note. The Company began to make equal monthly payments of principal and interest, beginning in the third quarter of 2021. The PPP Note may be prepaid in part or in full, at any time, without penalty. The PPP Note provides for certain customary events of default, including (i) failing to make a payment when due under the PPP Note, (ii) failure to do anything required by the PPP Note or any other loan document, (iii) defaults of any other loan with SVB, (iv) failure to disclose any material fact or make a materially false or misleading representation to SVB or SBA, (v) default on any loan or agreement with another creditor, if SVB believes the default may materially affect the Company’s ability to pay the PPP Note, (vi) failure to pay any taxes when due, (vii) becoming the subject of a proceeding under any bankruptcy or insolvency law, having a receiver or liquidator appointed for any part of the Company’s business or property, or making an assignment for the benefit of creditors, (viii) having any adverse change in financial condition or business operation that the SVB believes may materially affect the Company’s ability to pay the PPP Note, (ix) if the Company reorganizes, merges, consolidates, or otherwise changes ownership or business structure without the SVB’s prior written consent, or (x) becoming the subject of a civil or criminal action that SVB believes may materially affect the Company’s ability to pay the PPP Note. Upon the occurrence of an event of default, SVB has customary remedies and may, among other things, require immediate payment of all amounts owed under the PPP Note, collect all amounts owing from the Company, and file suit and obtain judgment against the Company. Convertible Preferred Stock and Warrants On November 9, 2020, the Company entered into the (the “Equity Line Agreement”) with Energy Capital, LLC, which provides that, upon the terms and subject to the conditions and limitations set forth therein, Energy Capital is committed to purchase up to an aggregate of $12.0 million of shares of the Company’s newly designated series B convertible preferred stock (the “Series B Preferred Stock”) at the Company’s request from time to time during the 24-month term of the Equity Line Agreement. Under the Equity Line Agreement, beginning January 21, 2021, subject to the satisfaction of certain conditions, including the Company having less than $8 million of cash, cash equivalents and other available credit (aside from availability under the Equity Line Agreement), the Company has the right, at sole discretion, to present Energy Capital with a purchase notice (each, a “Regular Purchase Notice”) directing Energy Capital (as principal) to purchase shares of Series B Preferred Stock at a price of $1,000.00 per share (not to exceed $4.0 million worth of shares) once per month, up to an aggregate of $12.0 million of our Series B Preferred Stock at a per share price (the “Purchase Price”) equal to $1,000.00 per share of Series B Preferred Stock, with each share of Series B Preferred Stock initially convertible into common stock, beginning six months after the date of its issuance, at a conversion price of $0.3951 per share, subject to customary anti-dilution adjustments, including in the event of any stock split. The Equity Line Agreement provides that the Company shall not affect any Regular Purchase under the Equity Line Agreement on any date where the closing price of our common stock on the NYSE American is less than $0.25 without the approval of Energy Capital. In addition, beginning on January 1, 2022, subject to the satisfaction of certain conditions, if the full $12.0 million of Series B Preferred Stock has not been sold pursuant to Regular Purchases, Energy Capital may, at its sole discretion, by its delivery to the Company of a Purchase Notice, from time to time, purchase up to the amount then remaining available under the Equity Line Agreement at the Purchase Price. The Company accounted for the Equity Line Agreement as a put/call option (the “Energy Capital Option”). This put/call option is classified as a liability in accordance with ASC 480 on the Company’s balance sheet and was recorded at the estimated fair value of $4.2 million upon issuance. The put/call option is required to be remeasured to fair value at each reporting period with the change recorded in change in fair value of derivatives that is a component of other income (expense). In connection with the issuance of the Equity Line Agreement, the Company incurred $7.6 million in debt issuance costs. The fair value as of September 30, 2021 was $91.1 million. Concurrently with entry into the Equity Line Agreement, the Company issued a warrant to Energy Capital, exercisable beginning May 9, 2021, to purchase up to 10,000,000 shares of common stock at an exercise price of $0.3951 per share (the “Warrant”). The Warrant expires, if unexercised, on November 9, 2030. On August 9, 2020, the Company entered into a Stock Purchase Agreement with Masters, pursuant to which the Company issued and sold to Masters 3,000 shares of Series A Preferred Stock, at a price of $1,000.00 per share in an initial closing. Masters also had the option to purchase up to an additional 27,000 shares of Series A Preferred Stock at a price of $1,000.00 per share in subsequent closings, subject to the terms and conditions of the Stock Purchase Agreement, as amended, through January 11, 2021. In January 2021, Masters and its assignees purchased in aggregate an additional 22,783 shares of Series A Preferred Stock, resulting in additional gross proceeds of $22.8 million. Each share of Series A Preferred Stock was initially convertible into a number of shares of common stock equal to $1,000.00 divided by the conversion price of $0.476 per share, subject to customary anti-dilution adjustments, including in the event of any stock split. As of September 30, 2021, all 25,783 shares of Series A Preferred Stock have been converted to common stock. Masters’ option to purchase the remaining unissued shares of Series A Preferred Stock expired on January 11, 2021, resulting in a gain on extinguishment of $3.5 million. Convertible Notes Highbridge Loan Agreement On April 21, 2020, the Company entered into the Highbridge Loan Agreement with certain funds managed by Highbridge Capital Management, LLC (“Highbridge”), as the lenders (together with the other lenders from time to time party thereto, the “Lenders”) and Wilmington Savings Fund Society, SCB, as collateral agent. Pursuant to the Highbridge Loan Agreement, the Company borrowed an aggregate principal amount of $15.0 million in aggregate principal through the issuance and sale of First Lien Notes (the “First Lien Notes”) on April 24, 2020. In connection with the Highbridge Loan Agreement and receipt of the first tranche of borrowing, the Company issued 1,500,000 shares of its common stock to the Lenders as a commitment fee. On August 14, 2020, the Company prepaid the First Lien Notes in full, including the discounted prepayment premium, in the amount of approximately $17.6 million and recognized a loss on extinguishment in the amount of $0.7 million. Exchange Agreement with Highbridge On April 21, 2020, the Company entered into a Note Purchase and Exchange Agreement with certain funds managed by Highbridge providing for the exchange of $24.0 million aggregate principal amount of the Company’s outstanding 2025 Notes for (i) $15.7 million aggregate principal amount of newly issued Second Lien Notes , (ii) 11,026,086 shares of common stock, (iii) warrants to purchase up to 4,500,000 shares of common stock at an exercise price of $0.66 per share, and (iv) $0.3 million in accrued and unpaid interest on the 2025 Notes being exchanged (the “Exchange”). The Exchange closed on April 24, 2020. During 2020, Highbridge voluntarily converted all $15.7 million of outstanding principal amount of the Second Lien Notes for 42,776,936 shares of the Company’s common stock. PHC Notes On August 9, 2020, the Company entered into a Note Purchase Agreement (the “Note Purchase Agreement”) with PHC, as the purchaser (together with the other purchasers from time to time party thereto, the “Note Purchasers”) and Alter Domus (US) LLC, as collateral agent. Pursuant to the Note Purchase Agreement, the Company borrowed $35.0 million in aggregate principal through the issuance and sale of the PHC Notes on August 14, 2020 (the “Closing Date”). The Company also issued 2,941,176 shares of its common stock, $0.001 par value per share to PHC as a financing fee (the “Financing Fee Shares”) on the Closing Date. The Financing Fee Shares are accounted for as debt discount in the amount of $1.5 million. The PHC Notes are senior secured obligations of the Company and will be guaranteed on a senior secured basis by the Company’s wholly owned subsidiary, Senseonics, Incorporated. Interest at the annual rate of 9.5% will be payable semi-annually in cash or, at the Company’s option, payment in kind. The interest rate will decrease to 8.0% if the Company obtains approval for 180-day Eversense for marketing in the United States, subject to certain conditions. The maturity date for the PHC Notes is October 31, 2024 (the “Maturity Date”). The obligations under the PHC Notes are secured by substantially all of the Company’s and its subsidiary’s assets. The Note Purchasers are entitled to convert the PHC Notes to common stock at a conversion rate of 1,867.4136 shares per $1,000 principal amount of the PHC Notes (including any interest added thereto as payment in kind), equivalent to a conversion price of approximately $0.54 per share, subject to specified anti-dilution adjustments, including adjustments for the Company’s issuance of equity securities on or prior to April 30, 2022 below the conversion price. In addition, following a notice of redemption or certain corporate events that occur prior to the maturity date, the Company will, in certain circumstances, increase the conversion rate for a holder who elects to convert its PHC Notes in connection with such notice of redemption or corporate event. In certain circumstances, the Company will be required to pay cash in lieu of delivering make whole shares unless the Company obtains stockholder approval to issue such shares. Subject to specified conditions, on or after October 31, 2022, the PHC Notes are redeemable by the Company if the closing sale price of the common stock exceeds 275% of the conversion price for a specified period of time and subject to certain conditions upon 10 days prior written notice at a cash redemption price equal to the then outstanding principal amount, plus any accrued but unpaid interest. On or after October 31, 2023, the PHC Notes are redeemable by the Company upon 10 days prior written notice at a cash redemption price equal to the then outstanding principal amount, plus any accrued but unpaid interest, plus a call premium of 130% if redeemed at least six months prior to the Maturity Date or a call premium of 125% if redeemed within six months of the Maturity Date. The Note Purchase Agreement contains customary terms and covenants, including financial covenants, such as operating within an approved budget and achieving minimum revenue and liquidity targets, and negative covenants, such as limitations on indebtedness, liens, mergers, asset transfers, certain investing activities and other matters customarily restricted in such agreements. Most of these restrictions are subject to certain minimum thresholds and exceptions. The Note Purchase Agreement also contains customary events of default, after which the PHC Notes become due and payable immediately, including defaults related to payment compliance, material inaccuracy of representations and warranties, covenant compliance, material adverse changes, bankruptcy and insolvency proceedings, cross defaults to certain other agreements, judgments against the Company, change of control or delisting events, termination of any guaranty, governmental approvals, and lien priority. The Company also has the option to sell and issue PHC up to $15.0 million of convertible preferred stock on or before December 31, 2022 (the “PHC Option”), contingent upon obtaining approval for the 180-day Eversense product for marketing in the United States before such date. This purchased put option represents a freestanding financial instrument and is recognized as an asset in the Company’s consolidated balance sheets at fair value on the date of issuance and subject to impairment testing in each reporting period prior to the options exercise or expiration. The Company acknowledges that while the purchased put option is subject to impairment testing, there is no explicit guidance regarding how impairment should be assessed and measured for the PHC purchased put option. As such, the measurement alternative in ASC 321 for equity securities without readily determinable fair values can be applied by analogy to assess and measure impairment of the purchased put option. The Company developed an estimated fair value at September 30, 2021 to be $0.2 million, and an impairment loss of $0.5 million for the three months ended September 30, 2021, was recognized in net income as the difference between the fair value of the investment and its carrying amount. The Note Purchase Agreement also contained several provisions requiring bifurcation as a separate derivative liability including an embedded conversion feature, mandatory prepayment upon event of default that constitutes a breach of the minimum revenue financial covenant, optional redemption upon an event of default, change in interest rate after PMA approval and default interest upon an event of default. The Company recorded the fair value of the embedded features in the amount of $25.8 million as a derivative liability in the Company’s consolidated balance sheets in accordance with ASC Topic 815, Derivatives and Hedging. The derivative is adjusted to fair value at each reporting period, with the change in the fair value recorded in change in fair value of derivatives that is a component of other income (expense) in the Company’s consolidated statement of operations and comprehensive loss. In connection with the issuance of the Note Purchase Agreement, the Company incurred $2.9 million in debt issuance costs and debt discounts. The associated debt issuance costs were recorded as a contra liability in the amount of $1.4 million and are deferred and amortized as additional interest expense over the term of the notes. 2025 Notes In July 2019, the Company issued $82.0 million in aggregate principal amount of senior convertible notes that will mature on January 15, 2025 (the “2025 Notes”), unless earlier repurchased or converted. The 2025 Notes are convertible, at the option of the holders, into shares of the Company’s common stock, at an initial conversion rate of 757.5758 shares per $1,000 principal amount of the 2025 Notes (equivalent to an initial conversion price of approximately $1.32 per share). The 2025 Notes also contained an embedded conversion option requiring bifurcation as a separate derivative liability, along with the fundamental change make-whole provision and the cash settled fundamental make-whole shares provision. The derivative is adjusted to fair value at each reporting period, with the change in the fair value recorded to other income (expense) in the Company’s consolidated statement of operations and comprehensive loss. In connection with the Exchange on April 24, 2020, $24.0 million aggregate principal of the Company’s outstanding 2025 Notes held by Highbridge were exchanged for $15.7 million of Second Lien Notes, (i) 11,026,086 shares of common stock, (ii) warrants to purchase up to 4,500,000 shares of common stock at an exercise price of $0.66 per share, and (iii) $0.3 million in accrued and unpaid interest on the 2025 Notes being exchanged. This transaction modified the original 2025 Notes outstanding with Highbridge and resulted in $13.2 million of deferred issuance fees and debt discounts associated with the exchanged 2025 Notes being transferred as a discount to the Second Lien Notes. For the nine months ended September 30, 2021, there were conversions of $6.5 million of outstanding principal amount of the 2025 notes for 4,924,998 shares of common stock. 2023 Notes In the first quarter of 2018, the Company issued $53.0 million in aggregate principal amount of senior convertible notes due February 1, 2023 (the “2023 Notes”). In July 2019, the Company used the net proceeds from the issuance of the 2025 Notes to repurchase $37.0 million aggregate principal amount of the outstanding 2023 Notes. Each $1,000 of principal of the 2023 Notes is initially convertible into 294.1176 shares of the Company’s common stock, which is equivalent to an initial conversion price of approximately $3.40 per share, subject to adjustment upon the occurrence of specified events. The Company bifurcated the embedded conversion option, along with the interest make-whole provision and make-whole fundamental change provision as a derivative liability. The derivative is adjusted to fair value at each reporting period, with the change in the fair value recorded in change in fair value of derivatives that is a component of other income (expense) in the Company’s consolidated statement of operations and comprehensive loss. The following carrying amounts were outstanding under the Company’s notes payable as of September 30, 2021 and December 31, 2020 (in thousands): September 30, 2021 Principal ($) Debt Discount ($) Issuance Costs ($) Carrying Amount ($) 2023 Notes 15,700 (1,824) - 13,876 2025 Notes 51,199 (21,742) (364) 29,093 PHC Notes 35,000 (19,610) (1,198) 14,192 PPP Loan 5,113 - - 5,113 December 31, 2020 Principal ($) Debt Discount ($) Issuance Costs ($) Carrying Amount ($) 2023 Notes 15,700 (2,755) - 12,945 2025 Notes 57,700 (28,276) (431) 28,993 PHC Notes 36,312 (22,237) (1,359) 12,716 PPP Loan 5,763 - - 5,763 Interest expense related to the notes payable for the three and nine months ended September 30, 2021 was as follows (dollars in thousands): Three months ended September 30, 2021 Effective Interest Rate Interest ($) Debt Discount and Fees ($) Issuance Costs ($) Loss on Extinguishment ($) Total Interest Expense ($) 2023 Notes 5.25% 206 318 - - 524 2025 Notes 5.25% 672 1,152 19 - 1,843 PHC Notes 9.50% 831 950 58 - 1,839 PPP Loan 1.00% 15 - - - 15 Total 1,724 2,420 77 - 4,221 Nine months ended September 30, 2021 Effective Interest Rate Interest ($) Debt Discount and Fees ($) Issuance Costs ($) Loss on Extinguishment ($) Total Interest Expense ($) 2023 Notes 5.25% 618 931 - - 1,549 2025 Notes 5.25% 2,044 3,362 56 3,183 8,645 PHC Notes 9.50% 2,456 2,627 161 - 5,244 PPP Loan 1.00% 44 - - - 44 Total 5,162 6,920 217 3,183 15,482 The following are the scheduled maturities of the Company’s notes payable as of September 30, 2021 (in thousands): 2021 (remaining three months) $ 2,191 2022 2,922 2023 15,700 2024 35,000 Thereafter 51,199 Total $ 107,012 |
Stockholders' Deficit
Stockholders' Deficit | 9 Months Ended |
Sep. 30, 2021 | |
Stockholders' Deficit | |
Stockholders' Deficit | 9. Stockholders’ Deficit In November 2019, the Company entered into an Open Market Sale Agreement with Jefferies LLC which allows the Company to issue and sell up to $50.0 million in gross proceeds of its common stock. During the nine months ended September 30, 2021 the Company sold 12,830,333 shares of common stock under the Open Market Sale Agreement, resulting in gross proceeds of $48.4 million. During the nine months ended September 30, 2020, the Company sold 175,289 shares of common stock under the Open Market Sale Agreement, resulting in gross proceeds of $0.1 million. During the nine months ended September 30, 2021, in addition to the shares sold under the Open Market Sale Agreement above, the Company sold 99,740,259 shares of common stock, of which 59,740,259 shares of common stock were sold in the Offering and 40,000,000 shares of common stock were sold in the Registered Direct Offering. During the nine months ended September 30, 2020, the Company did not sell any shares of common stock, other than the shares sold under the Open Market Sale Agreement. For additional information on the Offering and the Registered Direct Offering, see Note 2—Liquidity and Capital Resources. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2021 | |
Stock-Based Compensation | |
Stock-Based Compensation | 10. Stock-Based Compensation 2015 Plan In December 2015, the Company adopted the 2015 Equity Incentive Plan (the “2015 Plan”), under which incentive stock options, non-qualified stock options and restricted stock units may be granted to the Company’s employees and certain other persons, such as officers and directors, in accordance with the 2015 Plan provisions. In February 2016, the Company’s Board of Directors adopted, and the Company’s stockholders approved, an Amended and Restated 2015 Equity Incentive Plan (the “amended and restated 2015 Plan”), which became effective on March 17, 2016. The Company’s board of directors may terminate the amended and restated 2015 Plan at any time. Options granted under the amended and restated 2015 Plan expire ten years after the date of grant. Pursuant to the amended and restated 2015 Plan, the number of shares of the Company’s common stock reserved for issuance automatically increases on January 1 of each year, ending on January 1, 2026, by 3.5% of the total number of shares of its common stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares as may be determined by its board of directors. As of September 30, 2021, 9,276,073 shares remained available for grant under the amended and restated 2015 Plan. Inducement Plan On May 30, 2019, the Company adopted the Senseonics Holdings, Inc. Inducement Plan (the “Inducement Plan”), pursuant to which the Company reserved 1,800,000 shares of the Company’s common stock for issuance. The only persons eligible to receive grants of awards under the Inducement Plan are individuals who satisfy the standards for inducement grants in accordance with NYSE American Company Guide Section 711(a), including individuals who were not previously an employee or director of the Company, or following a bona fide period of non-employment, as an inducement material to such persons entering into employment with the Company. An “Award” is any right to receive the Company’s common stock pursuant to the Inducement Plan, consisting of non-statutory options, restricted stock unit awards and other equity incentive awards. As of September 30, 2021, 735,375 shares remained available for grant under the Inducement Plan. 2016 Employee Stock Purchase Plan In February 2016, the Company adopted the 2016 Employee Stock Purchase Plan, (the “2016 ESPP”). The 2016 ESPP became effective on March 17, 2016. The maximum number of shares of common stock that may be issued under the 2016 ESPP was initially 800,000 shares and automatically increases on January 1 of each year, ending on and including January 1, 2026, by 1.0% of the total number of shares of common stock outstanding on December 31 of the preceding calendar year; provided, however, the Board of Directors may act prior to the first day of any calendar year to provide that there will be no January 1 increase in the share reserve for such calendar year or that the increase in the share reserve for such calendar year will be a lesser number of shares of common stock. At September 30, 2021 there were 8,670,753 shares of common stock available for issuance under the 2016 ESPP. The 2016 ESPP permits participants to purchase shares of the Company’s common stock through payroll deductions of up to 15% of their earnings. Unless otherwise determined by the administrator, the purchase price of the shares will be 85% of the lower of the fair market value of common stock on the first day of an offering or on the date of purchase. Participants may end their participation at any time and deductions not yet used in a purchase are refundable upon employment termination. The Company initiated its first 2016 ESPP offering period on August 1, 2019 and new offering periods occur every six months thereafter, each consisting of two purchase periods of six months in duration ending on or about January 31st and July 31st of each year. A participant may only be in one offering at a time. On February 1, 2020, there were 566,573 shares purchased in connection with the initial offering period. The 2016 ESPP contains an offering reset provision whereby if the fair market value of a share on offering date of an ongoing offering is less than or equal to the fair market value of a share on a new offering date, the ongoing offering will terminate immediately after the purchase date and rolls over to the new offering. The 2016 ESPP is considered compensatory for financial reporting purposes. 1997 Plan On May 8, 1997, the Company adopted the 1997 Stock Option Plan (the “1997 Plan”), under which incentive stock options, non-qualified stock options, and restricted stock awards may be granted to the Company’s employees and certain other persons in accordance with the 1997 Plan provisions. Approximately 2,115,534 shares of the Company’s common stock underlying options have vested under the 1997 Plan. Upon the effectiveness of the 2015 Plan, the Company no longer grants any awards under the 1997 Plan. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Measurements | |
Fair Value Measurements | 11. Fair Value Measurements The following table represents the fair value hierarchy of the Company’s financial assets and liabilities measured at fair value on a recurring basis at September 30, 2021 and December 31, 2020 (in thousands): September 30, 2021 Total Level 1 Level 2 Level 3 Assets Money market funds⁽¹⁾ $ 43,818 $ 43,818 $ — $ — Corporate debt securities 40,085 — 40,085 — Commercial paper 62,336 — 62,336 — Government and agency securities 20,050 20,050 — — PHC Option 236 — — 236 Liabilities Energy Capital Option $ 91,097 $ — $ — $ 91,097 Embedded features of the 2023 Notes 9,492 — — 9,492 Embedded features of the PHC Notes 195,727 — — 195,727 Embedded features of the 2025 Notes 112,085 — 112,085 — December 31, 2020 Total Level 1 Level 2 Level 3 Assets Money market funds⁽¹⁾ $ 3 $ 3 $ — $ — PHC Option 1,886 — — 1,886 Liabilities Energy Capital Option $ 16,255 $ — $ — $ 16,255 Masters Option 23,479 — — 23,479 Embedded features of the 2023 Notes 622 — — 622 Embedded features of the PHC Notes 45,647 — — 45,647 Embedded features of the 2025 Notes 15,850 — 15,850 — (1) Classified as cash and cash equivalents due to their short-term maturity The following table provides a reconciliation of the beginning and ending net balances of items measured at fair value on a recurring basis that used significant unobservable inputs (Level 3) (in thousands): Level 3 Instruments December 31, 2020 $ 84,117 Conversion of financial instruments (19,973) Loss on fair value adjustment of option 74,848 Loss on change in fair value of derivatives 158,951 Gain on extinguishment of option (3,513) Financial asset impairment cost 1,650 September 30, 2021 $ 296,080 The recurring Level 3 fair value measurements of the embedded features of the notes payable include the following significant unobservable inputs at September 30, 2021: 2023 Notes PHC Notes Unobservable Inputs Assumptions Assumptions Risky (bond) rate 30.0 % 15.0 % Stock price volatility 95.0 % 95.0 % Probabilities of conversion provisions 5.0 - 90.0 % 5.0 - 75.0 % Time period until maturity (yrs) 0.50 - 1.34 0.50 - 3.08 Dividend yield — % — % |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2021 | |
Income Taxes | |
Income Taxes | 12. Income Taxes The Company has no t recorded any tax provision or benefit for the nine months ended September 30, 2021 or September 30, 2020. The Company has provided a valuation allowance for the full amount of its net deferred tax assets since realization of any future benefit from deductible temporary differences, NOL carryforwards and research and development credits is not more-likely-than-not to be realized at September 30, 2021 and December 31, 2020. On March 27, 2020, Congress enacted the CARES Act, as amended by the Flexibility Act, to provide certain relief as a result of the COVID-19 pandemic. The enactment of the CARES Act did not result in any material adjustments to the Company’s income tax provision or net deferred tax assets for the nine months ended September 30, 2021. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2021 | |
Related Party Transactions | |
Related Party Transactions | 13. Related Party Transactions Ascensia, through the ownership interests of its parent company, PHC, has a noncontrolling ownership interest in the Company. Ascensia also has representation on the Company’s board of directors. and the amount due from Ascensia as of September 30, 2021 was $3.5 million. At September 30, 2021, the Company had estimated replacement obligations under warranties in the amount of $1.7 million. |
Reclassification of Prior Year
Reclassification of Prior Year Presentation | 9 Months Ended |
Sep. 30, 2021 | |
Reclassification of Prior Year Presentation | |
Reclassification of Prior Year Presentation | 14. Reclassification of Prior Year Presentation Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect on the reported results of operations. An adjustment has been made to the Consolidated Statements of Cash Flows for the nine months ended September 30, 2020 |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2021 | |
Subsequent Events | |
Subsequent Events | 15. Subsequent Events In November 2021, the Company entered into an Open Market Sale Agreement (the “2021 Sales Agreement”) with Jefferies LLC (“Jeffries”), under which the Company could offer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $150.0 million through Jeffries as its sales agent in an “at the market” offering. Jeffries will receive a commission up to 3.0% of the gross proceeds of any common stock sold through Jeffries under the 2021 Sales Agreement. As of the date of this Quarterly Report on Form 10-Q, there have been no offer and sales of the Company’s common stock under the 2021 Sales Agreement. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. Although the Company considers the disclosures in these unaudited consolidated financial statements to be adequate to make the information presented not misleading, certain information or footnote information normally included in consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted as permitted under the rules and regulations of the United States Securities and Exchange Commission (“SEC”). In the opinion of management, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair statement of financial position at September 30, 2021, and December 31, 2020, results of operations, comprehensive income (loss), and changes in stockholder’s equity (deficit) for the three and nine months ended September 30, 2021, and 2020 and cash flows for the nine months ended September 30, 2021, and 2020 have been included. The unaudited condensed consolidated financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the SEC on March 5, 2021. The interim results for September 30, 2021, are not necessarily indicative of the results to be expected for the year ending December 31, 2021, or for any future interim periods. The consolidated financial statements reflect the accounts of Senseonics Holdings, Inc. and its wholly owned operating subsidiary Senseonics Incorporated. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenue and expenses during the reporting period. In the accompanying unaudited consolidated financial statements, estimates are used for, but not limited to, stock-based compensation, recoverability of long-lived assets, deferred taxes and valuation allowances, derivative assets and liabilities, obsolete inventory, warranty obligations, variable consideration related to revenue, depreciable lives of property and equipment, and accruals for clinical study costs, which are accrued based on estimates of work performed under contract. The Company considered COVID-19 related impacts to its estimates, as appropriate, within its unaudited condensed consolidated financial statements and there may be changes to those estimates in future periods due to the uncertainties surrounding the severity and duration of the COVID-19 pandemic. Actual results could differ from those estimates; however, management does not believe that such differences would be material. |
Segment Information | Segment Information The Company views its operations and manages its business in one segment, glucose monitoring products. |
Comprehensive Loss | Comprehensive Loss Comprehensive income (loss) comprises net income (loss) and other changes in equity that are excluded from net income (loss). For the three and nine months ended September 30, 2021, the Company’s comprehensive income (loss) included less than $0.1 million of other comprehensive income related to the unrealized gain on marketable securities. For the three and nine months ended September 30, 2020, the Company’s net loss equaled its comprehensive loss and, accordingly, no additional disclosure is presented. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers highly liquid investments with original maturities of three months or less from the date of purchase to be cash equivalents. These investments are carried at cost, which approximates fair value. Cash and cash equivalents consisted of the following as of the periods listed below (in thousands): September 30, December 31, 2021 2020 Cash ⁽ ¹ ⁾ $ 2,393 $ 18,002 Money market funds 43,818 3 Cash and cash equivalents $ 46,211 $ 18,005 (1) Includes overnight repurchase agreements |
Restricted Cash | Restricted Cash The Company’s restricted cash previously included pledged cash as collateral related to its credit card program with Silicon Valley Bank (“SVB”). The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets that sum to the total of the same such amounts shown in the statement of cash flows (in thousands): September 30, December 31, 2021 2020 Cash and cash equivalents $ 46,211 $ 18,005 Restricted cash — 200 Cash, cash equivalents and restricted cash $ 46,211 $ 18,205 |
Long-lived Assets | Long-lived Assets Management reviews long-lived assets, including property and equipment and right-of-use assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of the long-lived asset is measured by a comparison of the carrying amount of the asset to future undiscounted net cash flows expected to be generated by the asset. If the undiscounted cash flows are less than the carrying amount, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the estimated fair value of the assets. Management identified an indicator of impairment for a right of use asset and recorded an immaterial expense for the nine months ended September 30, 2021. There was no impairment recorded for the three months ended September 30, 2021. |
Warranty Obligation | Warranty Obligation The Company provides a warranty of one year on its smart transmitters. Additionally, the Company may also replace Eversense system components that do not function in accordance with the product specifications. Estimated replacement costs are recorded at the time of shipment as a charge to cost of sales in the consolidated statement of operations and are developed by analyzing product performance data and historical replacement experience, including comparing actual replacements to revenue. At September 30, 2021, and December 31, 2020, the warranty reserve for both periods was $0.6 million. The following table provides a reconciliation of the change in estimated warranty liabilities for the nine months ended September 30, 2021 and for the twelve months ended December 31, 2020 (in thousands): September 30, December 31, 2021 2020 Balance at beginning of the period $ 646 $ 2,197 Provision for warranties during the period 760 (266) Settlements made during the period (844) (1,285) Balance at end of the period $ 562 $ 646 |
Revenue | Revenue The Company recognizes revenue in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition, the entity performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The Company generates revenue from sales of its Eversense CGM system and related components at a fixed price to third-party distributors in the European Union and to strategic fulfillment partners in the United States, and a combination of fixed and variable prices to its strategic partner, Ascensia (collectively, “Customers”), who then resell the products to health care providers and patients. The Company is paid for its sales directly to the Customers, regardless of whether or not the Customers resell the products to health care providers and patients. Customer contracts do not include the right to return unless there is a product issue, in which case the Company may provide replacement product. Product conformity guarantees do not create additional performance obligations and are accounted for as warranty obligations in accordance with guarantee and loss contingency accounting guidance. Revenue is recognized, at a point in time, when the Customers obtain control of the product based upon the delivery terms as defined in the contract, at an amount that reflects the consideration which is expected to be received in exchange for the product. Contracts with the Customers include performance obligations for supply of goods and the performance obligation is typically satisfied upon transfer of control of the product. Distribution contracts may also contain requirements for training and customer service support; however, these are not assessed as performance obligations given the activities are considered immaterial in the context of the contract. The payment terms and conditions of the Customers vary, but the Company is typically paid within 60 days of invoicing subsequent to the Customers obtaining control of the Company’s product. The Company’s contracts contain variable consideration such as prompt-pay discounts, tier-volume price discounts and for the Ascensia commercial agreement, revenue share. Variable consideration, such as discounts and prompt-pay incentives, are treated as a reduction in revenue and variable consideration, such as revenue share is treated as an addition in revenue when the product sale is recognized. The amount of variable consideration that is included in the transaction price may be constrained and is included in revenue only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period, when the uncertainty associated with the variable consideration is subsequently resolved. Estimating variable consideration and the related constraint requires the use of significant management judgement. Depending on the variable consideration, the Company estimates the expected value based on the terms of the agreements, historical data, geographic mix, reimbursement rates, and market conditions. The Company’s estimates used in determining the variable consideration on a sale transaction may be adjusted each reporting period depending on actual results, provided a change does not reflect a modification to the original contract. Contract assets consist of trade receivables and unbilled receivables from customers and are recorded at net realizable value. Unbilled receivables relate to the revenue share variable consideration from the Ascensia commercial agreement. Concentration of Revenue and Customers For the three months ended September 30, 2021, the Company derived 92% of its total revenue from one customer, Ascensia. For the three months ended September 30, 2020, the Company derived 33% of its total revenue from one customer, Roche Diabetes Care GmbH. For the nine months ended September 30, 2021, the Company derived 88% of its total revenue from one customer, Ascensia. For the nine months ended September 30, 2020, the Company derived 29% of its total revenue from one customer, Roche Diabetes Care GmbH. Revenues for these corresponding periods represent purchases for sensors, transmitters and miscellaneous Eversense system components. Revenue by Geographic Region The following table sets forth net revenue derived from the Company’s two primary geographical markets, the United States and outside of the United States, based on the geographic location to which the Company delivers the product, for the three and nine months ended September 30, 2021 and 2020: Three Months Ended Nine Months Ended September 30, 2021 September 30, 2021 % % (Dollars in thousands) Amount of Total Amount of Total Revenue, net: Outside of the United States $ 2,928 82.9 % $ 7,771 80.4 % United States 604 17.1 1,896 19.6 Total $ 3,532 100.0 % $ 9,667 100.0 % Three Months Ended Nine Months Ended September 30, 2020 September 30, 2020 % % (Dollars in thousands) Amount of Total Amount of Total Revenue, net: Outside of the United States $ 258 33.6 % $ 325 30.5 % United States 509 66.4 739 69.5 Total $ 767 100.0 % $ 1,064 100.0 % |
Marketable Securities | Marketable Securities Marketable securities consist of commercial paper, corporate debt securities, asset backed securities and government and agency securities. The Company’s investments are classified as available for sale. Such securities are carried at fair value, with any unrealized holding gains or losses reported, net of any tax effects reported, as accumulated other comprehensive income. Realized gains and losses and declines in value judged to be other-than-temporary, if any, are included in consolidated results of operations. A decline in the market value of any available for sale security below cost that is deemed to be other-than-temporary results in a reduction in fair value, which is charged to earnings in that period, and a new cost basis for the security is established. Dividend and interest income is recognized when earned. The cost of securities sold is calculated using the specific identification method. The Company classifies all available-for-sale marketable securities with maturities greater than one year from the balance sheet date as non-current assets. |
Accounts Receivable | Accounts Receivable Accounts receivable consist of amounts due from the Company’s Customers and are recorded at net realizable value, which may include reductions for allowances for doubtful accounts at the time potential collection risk is identified or for promotional or prompt-pay discounts offered. The Company does not have a history of collectability concerns and no allowance for uncollectible accounts was recorded as of September 30, 2021, however, an immaterial allowance for uncollectible accounts was recorded as of December 31, 2020. Accounts receivable as of September 30, 2021 included unbilled accounts receivable of $2.0 million. The Company expects to invoice and collect all unbilled accounts receivable within 12 months. |
Net Income (Loss) per Share | Net Income (Loss) per Share Basic net income per share attributable to common stockholders is calculated by dividing the net income attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net income per share is computed using the weighted average number of common shares outstanding during the period and, when dilutive, potential common share equivalents. Basic net loss per share is computed by dividing net loss available to common stockholders by the weighted average number of shares of common stock outstanding during the period. Potentially dilutive common shares consist of shares issuable from restricted stock units, warrants, and our convertible notes. Potentially dilutive common shares issuable upon vesting of restricted stock units and exercise of stock options and warrants are determined using the average share price for each period under the treasury stock method. Potentially dilutive common shares issuable upon conversion of our convertible notes are determined using the if converted method. In periods of net loss, all potentially dilutive common shares are excluded from the computation of the diluted net loss per share for those periods, as the effect would be anti-dilutive. The following table sets forth the computation of basic and diluted net income per share for the periods shown: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Net income (loss) 42,914 (23,428) (386,907) (73,536) Impact of conversion of dilutive securities 1,385 - - - Dilutive Net income (loss) 44,299 (23,428) (386,907) (73,536) Net income (loss) per share Basic 0.10 (0.10) (0.93) (0.33) Diluted 0.08 (0.10) (0.93) (0.33) Basic weighted average shares outstanding 445,378,308 236,519,812 414,128,283 220,250,060 Dilutive potential common stock outstanding Stock-based awards 15,520,414 - - - 2023 Notes 4,617,646 - - - 2025 Notes 39,689,142 - - - PHC Notes 65,348,857 - - - Warrants 11,206,148 - - - Diluted weighted average shares outstanding 581,760,516 236,519,812 414,128,283 220,250,060 For the nine months ended September 30, 2021, as well as for the three and nine months ended September 30, 2020, the Company operated at a loss. Accordingly, all potentially dilutive shares were considered antidilutive, and basic and diluted EPS are the same. Outstanding anti-dilutive securities not included in the diluted net income per share attributable to common stockholders calculations were as follows: Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Stock-based awards 1,949,958 27,972,959 28,502,846 27,972,959 2023 Notes — 6,672,500 4,617,646 6,672,500 2025 Notes — 44,429,624 39,689,142 44,429,624 PHC Notes — 65,359,000 65,757,177 65,359,000 Second Lien Notes — 18,085,140 — 18,085,140 Warrants 116,581 9,696,581 13,177,822 9,696,581 Total anti-dilutive shares outstanding 2,066,539 172,215,804 151,744,633 172,215,804 |
Exit or Disposal Costs | Exit or Disposal Costs Costs associated with exit or disposal activities, such as restructuring, sale or termination of a line of business, the closure of business activities in a particular location, the relocation of business activities, changes in management structure and a fundamental reorganization that affects the nature and focus of operations, are recognized and measured initially at their fair values during the period in which an obligation meets the definition of a liability. There were no exit or disposal activities for the three and nine months ended September 30, 2021. The Company’s workforce reduction on March 26, 2020 did not permit continuation of service past March 31, 2020 and associated one-time employee termination benefit costs in the amount of $1.4 million were paid and recorded in the Company’s accompanying unaudited consolidated financial statements for the nine months ended September 30, 2020. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Recently Adopted In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes Not Yet Adopted In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses: Measurement of Credit Losses on Financial Instruments In August 2020, the FASB issued ASU 2020-06, Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contract in Entity’s Own Equity (Subtopic 815-40). |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Summary of Significant Accounting Policies | |
Schedule of cash and cash equivalents | September 30, December 31, 2021 2020 Cash ⁽ ¹ ⁾ $ 2,393 $ 18,002 Money market funds 43,818 3 Cash and cash equivalents $ 46,211 $ 18,005 (1) Includes overnight repurchase agreements |
Schedule of restricted cash | September 30, December 31, 2021 2020 Cash and cash equivalents $ 46,211 $ 18,005 Restricted cash — 200 Cash, cash equivalents and restricted cash $ 46,211 $ 18,205 |
Schedule of estimated warranty liabilities | September 30, December 31, 2021 2020 Balance at beginning of the period $ 646 $ 2,197 Provision for warranties during the period 760 (266) Settlements made during the period (844) (1,285) Balance at end of the period $ 562 $ 646 |
Schedule of revenue by geographic region | Three Months Ended Nine Months Ended September 30, 2021 September 30, 2021 % % (Dollars in thousands) Amount of Total Amount of Total Revenue, net: Outside of the United States $ 2,928 82.9 % $ 7,771 80.4 % United States 604 17.1 1,896 19.6 Total $ 3,532 100.0 % $ 9,667 100.0 % Three Months Ended Nine Months Ended September 30, 2020 September 30, 2020 % % (Dollars in thousands) Amount of Total Amount of Total Revenue, net: Outside of the United States $ 258 33.6 % $ 325 30.5 % United States 509 66.4 739 69.5 Total $ 767 100.0 % $ 1,064 100.0 % |
Schedule of computation of basic and diluted net income per share | Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Net income (loss) 42,914 (23,428) (386,907) (73,536) Impact of conversion of dilutive securities 1,385 - - - Dilutive Net income (loss) 44,299 (23,428) (386,907) (73,536) Net income (loss) per share Basic 0.10 (0.10) (0.93) (0.33) Diluted 0.08 (0.10) (0.93) (0.33) Basic weighted average shares outstanding 445,378,308 236,519,812 414,128,283 220,250,060 Dilutive potential common stock outstanding Stock-based awards 15,520,414 - - - 2023 Notes 4,617,646 - - - 2025 Notes 39,689,142 - - - PHC Notes 65,348,857 - - - Warrants 11,206,148 - - - Diluted weighted average shares outstanding 581,760,516 236,519,812 414,128,283 220,250,060 |
Schedule of anti-dilutive shares which have been excluded from the computation of diluted net loss per share | Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Stock-based awards 1,949,958 27,972,959 28,502,846 27,972,959 2023 Notes — 6,672,500 4,617,646 6,672,500 2025 Notes — 44,429,624 39,689,142 44,429,624 PHC Notes — 65,359,000 65,757,177 65,359,000 Second Lien Notes — 18,085,140 — 18,085,140 Warrants 116,581 9,696,581 13,177,822 9,696,581 Total anti-dilutive shares outstanding 2,066,539 172,215,804 151,744,633 172,215,804 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Marketable Securities | |
Schedule of marketable securities available for sale | Marketable securities available for sale, were as follows (in thousands): September 30, 2021 Gross Gross Estimated Amortized Unrealized Unrealized Market Cost Gains Losses Value Commercial Paper $ 62,336 — — $ 62,336 Corporate debt securities $ 40,084 5 (4) $ 40,085 Asset backed securities $ 27,869 5 (4) $ 27,870 Government and agency securities $ 24,630 5 (5) $ 24,630 Total $ 154,919 $ 15 $ (13) $ 154,921 |
Schedule of maturities of marketable securities | The following are the scheduled maturities as of September 30, 2021 (in thousands): 2021 (remaining three months) $ 4,999 2022 149,922 2023 — 2024 — Thereafter — Total $ 154,921 |
Inventory, net (Tables)
Inventory, net (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Inventory, net | |
Schedule of Inventory, net | Inventory, net of reserves, consisted of the following (in thousands): September 30, December 31, 2021 2020 Finished goods $ 1,927 $ 203 Work-in-process 4,513 2,626 Raw materials 1,438 2,452 Total $ 7,878 $ 5,281 |
Prepaid Expenses and Other Cu_2
Prepaid Expenses and Other Current Assets (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Prepaid Expenses and Other Current Assets | |
Schedule of prepaid expenses and other current assets | Prepaid expenses and other current assets consisted of the following (in thousands): September 30, December 31, 2021 2020 Contract manufacturing⁽¹⁾ $ 2,431 $ 3,324 Interest receivable 378 — Insurance 266 50 IT and software 266 150 Research and development 115 — Rent 105 102 Other 171 148 Total prepaid expenses and other current assets $ 3,732 $ 3,774 (1) Includes deposits to contract manufacturers for manufacturing process . |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Accrued Expenses and Other Current Liabilities | |
Schedule of accrued expenses and other current liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): September 30, December 31, 2021 2020 Compensation and benefits $ 3,010 $ 4,344 Interest on notes payable 2,098 1,773 Professional and administration services 1,945 880 Product warranty and replacement obligations 1,783 646 Contract manufacturing 1,629 1,421 Research and development 1,454 842 Sales and marketing services 1,149 615 Operating lease 875 794 Other 42 151 Patient access programs — 208 Total accrued expenses and other current liabilities $ 13,985 $ 11,674 |
Notes Payable, Preferred Stoc_2
Notes Payable, Preferred Stock and Stock Purchase Warrants (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Notes Payable, Preferred Stock and Stock Purchase Warrants | |
Schedule of carrying amounts outstanding under the Company's notes payable | The following carrying amounts were outstanding under the Company’s notes payable as of September 30, 2021 and December 31, 2020 (in thousands): September 30, 2021 Principal ($) Debt Discount ($) Issuance Costs ($) Carrying Amount ($) 2023 Notes 15,700 (1,824) - 13,876 2025 Notes 51,199 (21,742) (364) 29,093 PHC Notes 35,000 (19,610) (1,198) 14,192 PPP Loan 5,113 - - 5,113 December 31, 2020 Principal ($) Debt Discount ($) Issuance Costs ($) Carrying Amount ($) 2023 Notes 15,700 (2,755) - 12,945 2025 Notes 57,700 (28,276) (431) 28,993 PHC Notes 36,312 (22,237) (1,359) 12,716 PPP Loan 5,763 - - 5,763 |
Schedule of interest expense related to the notes payable | Interest expense related to the notes payable for the three and nine months ended September 30, 2021 was as follows (dollars in thousands): Three months ended September 30, 2021 Effective Interest Rate Interest ($) Debt Discount and Fees ($) Issuance Costs ($) Loss on Extinguishment ($) Total Interest Expense ($) 2023 Notes 5.25% 206 318 - - 524 2025 Notes 5.25% 672 1,152 19 - 1,843 PHC Notes 9.50% 831 950 58 - 1,839 PPP Loan 1.00% 15 - - - 15 Total 1,724 2,420 77 - 4,221 Nine months ended September 30, 2021 Effective Interest Rate Interest ($) Debt Discount and Fees ($) Issuance Costs ($) Loss on Extinguishment ($) Total Interest Expense ($) 2023 Notes 5.25% 618 931 - - 1,549 2025 Notes 5.25% 2,044 3,362 56 3,183 8,645 PHC Notes 9.50% 2,456 2,627 161 - 5,244 PPP Loan 1.00% 44 - - - 44 Total 5,162 6,920 217 3,183 15,482 |
Schedule of future maturities | The following are the scheduled maturities of the Company’s notes payable as of September 30, 2021 (in thousands): 2021 (remaining three months) $ 2,191 2022 2,922 2023 15,700 2024 35,000 Thereafter 51,199 Total $ 107,012 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Measurements | |
Schedule of fair value hierarchy of the Company's financial assets and liabilities measured at fair value on a recurring basis | The following table represents the fair value hierarchy of the Company’s financial assets and liabilities measured at fair value on a recurring basis at September 30, 2021 and December 31, 2020 (in thousands): September 30, 2021 Total Level 1 Level 2 Level 3 Assets Money market funds⁽¹⁾ $ 43,818 $ 43,818 $ — $ — Corporate debt securities 40,085 — 40,085 — Commercial paper 62,336 — 62,336 — Government and agency securities 20,050 20,050 — — PHC Option 236 — — 236 Liabilities Energy Capital Option $ 91,097 $ — $ — $ 91,097 Embedded features of the 2023 Notes 9,492 — — 9,492 Embedded features of the PHC Notes 195,727 — — 195,727 Embedded features of the 2025 Notes 112,085 — 112,085 — December 31, 2020 Total Level 1 Level 2 Level 3 Assets Money market funds⁽¹⁾ $ 3 $ 3 $ — $ — PHC Option 1,886 — — 1,886 Liabilities Energy Capital Option $ 16,255 $ — $ — $ 16,255 Masters Option 23,479 — — 23,479 Embedded features of the 2023 Notes 622 — — 622 Embedded features of the PHC Notes 45,647 — — 45,647 Embedded features of the 2025 Notes 15,850 — 15,850 — (1) Classified as cash and cash equivalents due to their short-term maturity |
Schedule of changes in the fair value of Level 3 derivative liability measured at fair value | The following table provides a reconciliation of the beginning and ending net balances of items measured at fair value on a recurring basis that used significant unobservable inputs (Level 3) (in thousands): Level 3 Instruments December 31, 2020 $ 84,117 Conversion of financial instruments (19,973) Loss on fair value adjustment of option 74,848 Loss on change in fair value of derivatives 158,951 Gain on extinguishment of option (3,513) Financial asset impairment cost 1,650 September 30, 2021 $ 296,080 |
Schedule of assumptions used to determine fair value | The recurring Level 3 fair value measurements of the embedded features of the notes payable include the following significant unobservable inputs at September 30, 2021: 2023 Notes PHC Notes Unobservable Inputs Assumptions Assumptions Risky (bond) rate 30.0 % 15.0 % Stock price volatility 95.0 % 95.0 % Probabilities of conversion provisions 5.0 - 90.0 % 5.0 - 75.0 % Time period until maturity (yrs) 0.50 - 1.34 0.50 - 3.08 Dividend yield — % — % |
Liquidity and Capital Resourc_2
Liquidity and Capital Resources (Details) - USD ($) $ / shares in Units, $ in Thousands | Jan. 31, 2021 | Jan. 27, 2021 | Jan. 26, 2021 | Jan. 21, 2021 | Jan. 17, 2021 | Nov. 09, 2020 | Aug. 09, 2020 | Apr. 24, 2020 | Jun. 30, 2021 | Nov. 30, 2019 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | Aug. 14, 2020 |
Net Income (Loss) | $ 42,914 | $ (23,428) | $ (386,907) | $ (73,536) | $ (175,200) | $ (115,500) | $ (94,000) | ||||||||||||
Accumulated deficit | (1,035,418) | (1,035,418) | $ (648,511) | ||||||||||||||||
Issuance of common stock, net | 200,440 | $ (86) | |||||||||||||||||
Cash, cash equivalents and marketable securities | $ 201,100 | $ 201,100 | |||||||||||||||||
Common stock, par value per share (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 | ||||||||||||||||
Highbridge Loan Agreement | |||||||||||||||||||
Aggregate principal amount | $ 15,000 | ||||||||||||||||||
Shares issued | 1,500,000 | ||||||||||||||||||
PHC Notes | |||||||||||||||||||
Aggregate principal amount | $ 35,000 | $ 35,000 | $ 35,000 | $ 36,312 | |||||||||||||||
Financing fee shares issued | 2,941,176 | ||||||||||||||||||
Conversion price | $ 0.54 | ||||||||||||||||||
Common stock, par value per share (in dollars per share) | $ 0.001 | ||||||||||||||||||
Ascensia | PHC Notes | |||||||||||||||||||
Aggregate principal amount | $ 35,000 | ||||||||||||||||||
Energy Capital, LLC | |||||||||||||||||||
Cash and cash equivalents and other available credit | $ 8,000 | ||||||||||||||||||
Energy Capital, LLC | Maximum | |||||||||||||||||||
Aggregate principal amount of convertible preferred equity | $ 4,000 | ||||||||||||||||||
Energy Capital, LLC | Forecast | Maximum | |||||||||||||||||||
Aggregate principal amount of convertible preferred equity | $ 12,000 | ||||||||||||||||||
Share price | $ 0.25 | ||||||||||||||||||
Convertible Preferred Equity | |||||||||||||||||||
Amount of possible additional debt principal amount | $ 15,000 | ||||||||||||||||||
Convertible Preferred Equity | Masters Capital | |||||||||||||||||||
Shares issued | 3,000 | ||||||||||||||||||
Convertible Preferred Equity | Energy Capital, LLC | |||||||||||||||||||
Aggregate principal amount of convertible preferred equity | $ 12,000 | ||||||||||||||||||
Price per share (in dollars per share) | $ 1,000 | ||||||||||||||||||
Collaboration and commercialization agreement term | 24 months | ||||||||||||||||||
Convertible Preferred Equity | Energy Capital, LLC | Forecast | |||||||||||||||||||
Share price | $ 1,000 | ||||||||||||||||||
Threshold redemption period of temporary equity | 6 months | ||||||||||||||||||
Conversion price | $ 0.3951 | ||||||||||||||||||
Series A Preferred Stock | |||||||||||||||||||
Aggregate principal amount of convertible preferred equity | $ 42,756 | ||||||||||||||||||
Series A Preferred Stock | Masters Capital | |||||||||||||||||||
Shares issued | 22,783 | ||||||||||||||||||
Price per share (in dollars per share) | $ 1,000 | $ 1,000 | $ 1,000 | ||||||||||||||||
Conversion price | $ 0.476 | ||||||||||||||||||
Proceeds from issuance of stock | $ 22,800 | ||||||||||||||||||
Series A Preferred Stock | Masters Capital | Maximum | |||||||||||||||||||
Shares issued | 27,000 | ||||||||||||||||||
Purchasers | |||||||||||||||||||
Shares issued | 40,000,000 | ||||||||||||||||||
Price per share (in dollars per share) | $ 1.25 | ||||||||||||||||||
Common stock, par value per share (in dollars per share) | $ 0.001 | ||||||||||||||||||
Net proceeds | $ 46,100 | ||||||||||||||||||
Proceeds from issuance of stock | $ 50,000 | ||||||||||||||||||
Overallotment | Public Offering | |||||||||||||||||||
Shares issued | 7,792,207 | 51,948,052 | |||||||||||||||||
Price per share (in dollars per share) | $ 1.925 | ||||||||||||||||||
Underwriters Share Price | $ 1.799875 | ||||||||||||||||||
Net proceeds | $ 106,100 | ||||||||||||||||||
Open Market Sale Agreement | |||||||||||||||||||
Shares issued | 12,830,333 | 12,830,333 | 175,289 | ||||||||||||||||
Proceeds from issuance of stock | $ 48,400 | $ 48,400 | $ 100 | ||||||||||||||||
Open Market Sale Agreement | Maximum | |||||||||||||||||||
Issuance of common stock, net | $ 50,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Segment Information (Details) | 9 Months Ended |
Sep. 30, 2021segment | |
Segment Information | |
Number of operating segments | 1 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Cash and Cash Equivalents (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2021 | Dec. 31, 2020 | |
Cash and Cash Equivalents, at Carrying Value [Abstract] | |||
Cash | $ 2,393 | $ 2,393 | $ 18,002 |
Money market funds | 43,818 | 43,818 | 3 |
Cash and cash equivalents | 46,211 | 46,211 | $ 18,005 |
Unrealized gain on marketable securities | 18 | 2 | |
Maximum | |||
Cash and Cash Equivalents, at Carrying Value [Abstract] | |||
Unrealized gain on marketable securities | $ 100 | $ 100 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Restricted Cash (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | Sep. 30, 2020 | Dec. 31, 2019 |
Cash and Cash Equivalents, at Carrying Value [Abstract] | ||||
Cash and cash equivalents | $ 46,211 | $ 18,005 | ||
Restricted cash | 200 | |||
Cash, cash equivalents, and restricted cash | $ 46,211 | $ 18,205 | $ 26,392 | $ 95,938 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Long-lived assets (Details) $ in Thousands | 3 Months Ended |
Sep. 30, 2021USD ($) | |
Property and Equipment, net | |
Impairment | $ 0 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Warranty Reserve (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Reconciliation of the change in estimated warranty liabilities | ||
Warranty term | 1 year | |
Balance at beginning of the period | $ 646 | $ 2,197 |
Provision for warranties during the period | (266) | |
Provision for warranties during the period | 760 | |
Settlements made during the period | (844) | (1,285) |
Balance at end of the period | $ 562 | $ 646 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Concentration of Revenue and Customers (Details) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021USD ($)itemcustomer | Sep. 30, 2020USD ($)customer | Sep. 30, 2021USD ($)itemcustomer | Sep. 30, 2020USD ($)customer | |
Estimated total revenue from major customers | ||||
Number of geographical markets | item | 2 | 2 | ||
Revenues | $ 3,532 | $ 767 | $ 9,667 | $ 1,064 |
Payment period | 60 days | |||
Revenue | Ascensia | ||||
Estimated total revenue from major customers | ||||
Number of customers | customer | 1 | 1 | ||
Revenue | Roche | ||||
Estimated total revenue from major customers | ||||
Number of customers | customer | 1 | 1 | ||
Revenue | Customer Concentration Risk | Ascensia | ||||
Estimated total revenue from major customers | ||||
Percentage of total revenue | 92.00% | 88.00% | ||
Revenue | Customer Concentration Risk | Roche | ||||
Estimated total revenue from major customers | ||||
Percentage of total revenue | 33.00% | 29.00% | ||
Revenue | Geographic Concentration Risk | ||||
Estimated total revenue from major customers | ||||
Percentage of total revenue | 100.00% | 100.00% | 100.00% | 100.00% |
Revenues | $ 3,532 | $ 767 | $ 9,667 | $ 1,064 |
Outside of the United States | Revenue | Geographic Concentration Risk | ||||
Estimated total revenue from major customers | ||||
Percentage of total revenue | 82.90% | 33.60% | 80.40% | 30.50% |
Revenues | $ 2,928 | $ 258 | $ 7,771 | $ 325 |
United States | Revenue | Geographic Concentration Risk | ||||
Estimated total revenue from major customers | ||||
Percentage of total revenue | 17.10% | 66.40% | 19.60% | 69.50% |
Revenues | $ 604 | $ 509 | $ 1,896 | $ 739 |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Accounts Receivable (Details) $ in Millions | Sep. 30, 2021USD ($) |
Accounts Receivable | |
Allowance for uncollectible accounts | $ 0 |
Unbilled accounts receivable | $ 2 |
Summary of Significant Accou_11
Summary of Significant Accounting Policies - Net Income (Loss) per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||||||
Net income (loss) | $ 42,914 | $ (23,428) | $ (386,907) | $ (73,536) | $ (175,200) | $ (115,500) | $ (94,000) |
Impact of conversion of dilutive securities | 1,385 | ||||||
Dilutive Net income (loss) | $ 44,299 | $ (23,428) | $ (386,907) | $ (73,536) | |||
Net income (loss) per share | |||||||
Basic | $ 0.10 | $ (0.10) | $ (0.93) | $ (0.33) | |||
Diluted | $ 0.08 | $ (0.10) | $ (0.93) | $ (0.33) | |||
Basic weighted average shares outstanding | 445,378,308 | 236,519,812 | 414,128,283 | 220,250,060 | |||
Dilutive potential common stock outstanding | |||||||
Warrants | 11,206,148 | ||||||
Diluted weighted average shares outstanding | 581,760,516 | 236,519,812 | 414,128,283 | 220,250,060 | |||
Net Loss per Share | |||||||
Total anti-dilutive shares outstanding | 2,066,539 | 172,215,804 | 151,744,633 | 172,215,804 | |||
Stock-based awards | |||||||
Dilutive potential common stock outstanding | |||||||
Stock-based awards | 15,520,414 | ||||||
Net Loss per Share | |||||||
Total anti-dilutive shares outstanding | 1,949,958 | 27,972,959 | 28,502,846 | 27,972,959 | |||
2023 Notes | |||||||
Dilutive potential common stock outstanding | |||||||
Convertible Notes | 4,617,646 | ||||||
Net Loss per Share | |||||||
Total anti-dilutive shares outstanding | 6,672,500 | 4,617,646 | 6,672,500 | ||||
2025 Notes | |||||||
Dilutive potential common stock outstanding | |||||||
Convertible Notes | 39,689,142 | ||||||
Net Loss per Share | |||||||
Total anti-dilutive shares outstanding | 44,429,624 | 39,689,142 | 44,429,624 | ||||
PHC Notes | |||||||
Dilutive potential common stock outstanding | |||||||
Convertible Notes | 65,348,857 | ||||||
Net Loss per Share | |||||||
Total anti-dilutive shares outstanding | 65,359,000 | 65,757,177 | 65,359,000 | ||||
Second Lien Notes | |||||||
Net Loss per Share | |||||||
Total anti-dilutive shares outstanding | 18,085,140 | 18,085,140 | |||||
Warrants | |||||||
Net Loss per Share | |||||||
Total anti-dilutive shares outstanding | 116,581 | 9,696,581 | 13,177,822 | 9,696,581 |
Summary of Significant Accou_12
Summary of Significant Accounting Policies - Exit or Disposal Costs (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2020USD ($) | |
Summary of Significant Accounting Policies | |
Benefit costs | $ 1.4 |
Marketable Securities - AFS Deb
Marketable Securities - AFS Debt Securities (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Marketable securities available for sale, consisting of debt securities: | |
Amortized Cost | $ 154,919 |
Gross Unrealized Gains | 15 |
Gross Unrealized Losses | (13) |
Estimated Market Value | 154,921 |
Commercial paper | |
Marketable securities available for sale, consisting of debt securities: | |
Amortized Cost | 62,336 |
Estimated Market Value | 62,336 |
Corporate debt securities | |
Marketable securities available for sale, consisting of debt securities: | |
Amortized Cost | 40,084 |
Gross Unrealized Gains | 5 |
Gross Unrealized Losses | (4) |
Estimated Market Value | 40,085 |
Asset backed Securities | |
Marketable securities available for sale, consisting of debt securities: | |
Amortized Cost | 27,869 |
Gross Unrealized Gains | 5 |
Gross Unrealized Losses | (4) |
Estimated Market Value | 27,870 |
Government and agency securities | |
Marketable securities available for sale, consisting of debt securities: | |
Amortized Cost | 24,630 |
Gross Unrealized Gains | 5 |
Gross Unrealized Losses | (5) |
Estimated Market Value | $ 24,630 |
Marketable Securities - AFS D_2
Marketable Securities - AFS Debt Securities - Maturities (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Debt Securities, Available-for-sale, Fair Value, Fiscal Year Maturity [Abstract] | |
2021 (remaining three months) | $ 4,999 |
2022 | 149,922 |
Total | $ 154,921 |
Inventory, net (Details)
Inventory, net (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Finished goods | $ 1,927 | $ 1,927 | $ 203 | |
Work-in-process | 4,513 | 4,513 | 2,626 | |
Raw materials | 1,438 | 1,438 | 2,452 | |
Total | 7,878 | 7,878 | $ 5,281 | |
Inventory Valuation and Obsolescence | ||||
Inventory adjustments included in cost of sales | ||||
Cost | $ 1,800 | $ 1,800 | $ 15,100 |
Prepaid Expenses and Other Cu_3
Prepaid Expenses and Other Current Assets (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Prepaid Expenses and Other Current Assets | ||
Contract manufacturing | $ 2,431 | $ 3,324 |
Interest receivable | 378 | |
Insurance | 266 | 50 |
IT and software | 266 | 150 |
Research and development | 115 | |
Rent | 105 | 102 |
Other | 171 | 148 |
Total prepaid expenses and other current assets | $ 3,732 | $ 3,774 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Accrued Expenses and Other Current Liabilities | ||
Compensation and benefits | $ 3,010 | $ 4,344 |
Interest on notes payable | 2,098 | 1,773 |
Professional and administration services | 1,945 | 880 |
Product warranty and replacement obligations | 1,783 | 646 |
Contract manufacturing | 1,629 | 1,421 |
Research and development | 1,454 | 842 |
Sales and marketing services | 1,149 | 615 |
Operating lease | 875 | 794 |
Other | 42 | 151 |
Patient access programs | 208 | |
Total accrued expenses and other current liabilities | $ 13,985 | $ 11,674 |
Notes Payable, Preferred Stoc_3
Notes Payable, Preferred Stock and Stock Purchase Warrants (Details) $ / shares in Units, $ in Thousands | Jan. 31, 2021USD ($)$ / sharesshares | Jan. 21, 2021USD ($)$ / shares | Nov. 09, 2020USD ($)$ / shares | Aug. 09, 2020USD ($)$ / sharesshares | Apr. 24, 2020USD ($)$ / sharesshares | Apr. 22, 2020USD ($) | Sep. 30, 2021USD ($)$ / shares | Sep. 30, 2021USD ($)$ / sharesshares | Sep. 30, 2020USD ($) | Dec. 31, 2020USD ($)$ / sharesshares | May 09, 2021$ / sharesshares | Aug. 14, 2020$ / sharesshares |
Debt Instrument [Line Items] | ||||||||||||
Loss on extinguishment | $ (3,183) | |||||||||||
Notes payable | ||||||||||||
Derivative assets | $ 236 | 236 | $ 1,886 | |||||||||
Carrying Amount | 57,161 | 57,161 | 57,216 | |||||||||
Derivative liabilities | $ 317,304 | $ 317,304 | $ 62,119 | |||||||||
Common stock, par value per share (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | $ 0.001 | |||||||||
Amount used to retire existing loans | $ 650 | $ 66,050 | ||||||||||
Highbridge Loan Agreement | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Final payment fee, notes | $ 17,600 | |||||||||||
Loss on extinguishment | (700) | |||||||||||
Notes payable | ||||||||||||
Principal amount | $ 15,000 | |||||||||||
Shares issued | shares | 1,500,000 | |||||||||||
Exchange Agreement with Highbridge | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Warrants to purchase shares | shares | 4,500,000 | |||||||||||
Exercise price of warrant (in dollars per share) | $ / shares | $ 0.66 | |||||||||||
Notes payable | ||||||||||||
Shares issued | shares | 11,026,086 | |||||||||||
Accrued and unpaid interest | $ 300 | |||||||||||
PHC Notes | ||||||||||||
Notes payable | ||||||||||||
Principal amount | $ 35,000 | $ 35,000 | $ 35,000 | $ 36,312 | ||||||||
Interest rate (as a percent) | 9.50% | 8.00% | 8.00% | |||||||||
Carrying Amount | $ 14,192 | $ 14,192 | 12,716 | |||||||||
Debt issuance costs and discounts | $ 1,400 | |||||||||||
Fair value of the embedded conversion option | $ 25,800 | |||||||||||
Effective Interest Rate | 9.50% | 9.50% | ||||||||||
Financing fee shares issued | shares | 2,941,176 | |||||||||||
Common stock, par value per share (in dollars per share) | $ / shares | $ 0.001 | |||||||||||
Debt discount of financing fee shares | $ 1,500 | |||||||||||
Conversion rate | 1,867.4136 | |||||||||||
Conversion price | $ / shares | $ 0.54 | |||||||||||
Conversion of Stock, Amount Issued | $ 15,000 | |||||||||||
Issuance costs incurred | 2,900 | $ 1,198 | $ 1,198 | 1,359 | ||||||||
Amount of principal which is converted to shares | $ 1 | |||||||||||
PHC Notes | Debt Redemption on or After October 31, 2022 | ||||||||||||
Notes payable | ||||||||||||
Threshold percentage of stock trigger | 275.00% | |||||||||||
Notice period | 10 days | |||||||||||
PHC Notes | Debt Redemption on or After October 31, 2023 | ||||||||||||
Notes payable | ||||||||||||
Notice period | 10 days | |||||||||||
PHC Notes | Debt Redemption Six Months Prior to Maturity Date | ||||||||||||
Notes payable | ||||||||||||
Call premium percentage | 130.00% | |||||||||||
PHC Notes | Debt Redemption Within Six Months of Maturity Date | ||||||||||||
Notes payable | ||||||||||||
Call premium percentage | 125.00% | |||||||||||
2025 Notes | Exchange Agreement with Highbridge | ||||||||||||
Notes payable | ||||||||||||
Principal amount | 24,000 | |||||||||||
Deferred issuance costs and debt discounts | 13,200 | |||||||||||
PPP Loan | ||||||||||||
Notes payable | ||||||||||||
Amount received from loan funding | $ 5,800 | |||||||||||
Principal amount | 5,113 | 5,113 | 5,763 | |||||||||
Interest rate (as a percent) | 1.00% | |||||||||||
Note term | 2 years | |||||||||||
Carrying Amount | $ 5,113 | $ 5,113 | 5,763 | |||||||||
Effective Interest Rate | 1.00% | 1.00% | ||||||||||
PPP Loan | Silicon Valley Bank | ||||||||||||
Notes payable | ||||||||||||
Principal amount | $ 5,800 | |||||||||||
Second Lien Notes | Exchange Agreement with Highbridge | ||||||||||||
Notes payable | ||||||||||||
Principal amount | $ 15,700 | |||||||||||
Original debt conversion amount | $ 15,700 | |||||||||||
Debt converted, Shares issued | shares | 42,776,936 | |||||||||||
PHC Option | Put option | ||||||||||||
Notes payable | ||||||||||||
Derivative assets | $ 200 | $ 200 | ||||||||||
Loss on fair value adjustment of derivatives | (500) | |||||||||||
Energy Capital Facility | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Exercise price of warrant (in dollars per share) | $ / shares | $ 0.3951 | |||||||||||
Notes payable | ||||||||||||
Deferred issuance costs and debt discounts | $ 7,600 | |||||||||||
Period to purchase stock | 24 months | |||||||||||
Cash Cash Equivalents and Other Available Credit Threshold | $ 8,000 | |||||||||||
Derivative liabilities | $ 4,200 | $ 91,100 | $ 91,100 | |||||||||
Energy Capital Facility | Maximum | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Warrants to purchase shares | shares | 10,000,000 | |||||||||||
Series B Preferred Stock | Energy Capital Facility | ||||||||||||
Notes payable | ||||||||||||
Preferred stock value | $ 12,000 | |||||||||||
Share price for debt conversion | $ / shares | $ 1,000 | |||||||||||
Period to purchase stock | 6 months | |||||||||||
Daily limit | $ 4,000 | |||||||||||
Conversion price | $ / shares | $ 0.3951 | |||||||||||
Series B Preferred Stock | Energy Capital Facility | Minimum | ||||||||||||
Notes payable | ||||||||||||
Share price for debt conversion | $ / shares | $ 0.25 | |||||||||||
Series B Preferred Stock | Energy Capital Facility | Maximum | ||||||||||||
Notes payable | ||||||||||||
Preferred stock value | $ 12,000 | |||||||||||
Series A Preferred Stock | ||||||||||||
Notes payable | ||||||||||||
Debt converted, Shares issued | shares | 25,783 | |||||||||||
Gain on extinguishment | $ 3,500 | |||||||||||
Series A Preferred Stock | Masters Capital | ||||||||||||
Notes payable | ||||||||||||
Shares issued | shares | 22,783 | |||||||||||
Conversion price | $ / shares | $ 0.476 | |||||||||||
Amount of principal which is converted to shares | $ 1 | |||||||||||
Number of shares issued and sold | shares | 27,000 | 3,000 | ||||||||||
Price per share (in dollars per share) | $ / shares | $ 1,000 | $ 1,000 | $ 1,000 | |||||||||
Additional shares issued | shares | 22,783 | |||||||||||
Gross proceeds from stock | $ 22,800 | |||||||||||
Series A Preferred Stock | Masters Capital | Maximum | ||||||||||||
Notes payable | ||||||||||||
Shares issued | shares | 27,000 |
Notes Payable, Preferred Stoc_4
Notes Payable, Preferred Stock and Stock Purchase Warrants - Term Notes Payable (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |
Jul. 31, 2019USD ($)$ / shares | Mar. 31, 2018USD ($)$ / shares | Sep. 30, 2021USD ($)shares | Dec. 31, 2020USD ($) | |
Long term debt | ||||
Loss on extinguishment of debt and issuance of debt | $ (3,183) | |||
2023 Notes | ||||
Long term debt | ||||
Principal amount | $ 53,000 | 15,700 | $ 15,700 | |
Conversion rate (per $1,000 of principal) | 294.1176 | |||
Conversion price (in dollars per share) | $ / shares | $ 3.40 | |||
Repurchase amount | $ 37,000 | |||
Amount of principal which is converted to shares | $ 1 | |||
2025 Notes | ||||
Long term debt | ||||
Principal amount | $ 82,000 | 51,199 | $ 57,700 | |
Conversion rate (per $1,000 of principal) | 757.5758 | |||
Conversion price (in dollars per share) | $ / shares | $ 1.32 | |||
Amount of principal which is converted to shares | $ 1 | |||
Original debt conversion amount | $ 6,500 | |||
Debt converted, Shares issued | shares | 4,924,998 | |||
Loss on extinguishment of debt and issuance of debt | $ (3,183) |
Notes Payable, Preferred Stoc_5
Notes Payable, Preferred Stock and Stock Purchase Warrants - Carrying amount of notes payable (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 | Aug. 09, 2020 | Jul. 31, 2019 | Mar. 31, 2018 |
Debt Instrument [Line Items] | |||||
Carrying Amount | $ 57,161 | $ 57,216 | |||
2023 Notes | |||||
Debt Instrument [Line Items] | |||||
Aggregate principal amount | 15,700 | 15,700 | $ 53,000 | ||
Debt Discount | (1,824) | (2,755) | |||
Carrying Amount | 13,876 | 12,945 | |||
2025 Notes | |||||
Debt Instrument [Line Items] | |||||
Aggregate principal amount | 51,199 | 57,700 | $ 82,000 | ||
Debt Discount | (21,742) | (28,276) | |||
Issuance costs | (364) | (431) | |||
Carrying Amount | 29,093 | 28,993 | |||
PHC Notes | |||||
Debt Instrument [Line Items] | |||||
Aggregate principal amount | 35,000 | 36,312 | $ 35,000 | ||
Debt Discount | (19,610) | (22,237) | |||
Issuance costs | (1,198) | (1,359) | $ (2,900) | ||
Carrying Amount | 14,192 | 12,716 | |||
PPP Loan | |||||
Debt Instrument [Line Items] | |||||
Aggregate principal amount | 5,113 | 5,763 | |||
Carrying Amount | $ 5,113 | $ 5,763 |
Notes Payable, Preferred Stoc_6
Notes Payable, Preferred Stock and Stock Purchase Warrants - Interest expense (Details) $ in Thousands | 3 Months Ended | 9 Months Ended |
Sep. 30, 2021USD ($) | Sep. 30, 2021USD ($) | |
Long term debt | ||
Interest | $ 1,724 | $ 5,162 |
Debt Discount & Fees | 2,420 | 6,920 |
Issuance Costs | 77 | 217 |
Loss on extinguishment of debt | 3,183 | |
Total Interest Expense | $ 4,221 | $ 15,482 |
2023 Notes | ||
Long term debt | ||
Effective Interest Rate | 5.25% | 5.25% |
Interest | $ 206 | $ 618 |
Debt Discount & Fees | 318 | 931 |
Total Interest Expense | $ 524 | $ 1,549 |
2025 Notes | ||
Long term debt | ||
Effective Interest Rate | 5.25% | 5.25% |
Interest | $ 672 | $ 2,044 |
Debt Discount & Fees | 1,152 | 3,362 |
Issuance Costs | 19 | 56 |
Loss on extinguishment of debt | 3,183 | |
Total Interest Expense | $ 1,843 | $ 8,645 |
PHC Notes | ||
Long term debt | ||
Effective Interest Rate | 9.50% | 9.50% |
Interest | $ 831 | $ 2,456 |
Debt Discount & Fees | 950 | 2,627 |
Issuance Costs | 58 | 161 |
Total Interest Expense | $ 1,839 | $ 5,244 |
PPP Loan | ||
Long term debt | ||
Effective Interest Rate | 1.00% | 1.00% |
Interest | $ 15 | $ 44 |
Total Interest Expense | $ 15 | $ 44 |
Notes Payable, Preferred Stoc_7
Notes Payable, Preferred Stock and Stock Purchase Warrants - Scheduled Maturities (Details) $ in Thousands | Sep. 30, 2021USD ($) |
Scheduled maturities | |
2021 (remaining three months) | $ 2,191 |
2022 | 2,922 |
2023 | 15,700 |
2024 | 35,000 |
Thereafter | 51,199 |
Total | $ 107,012 |
Stockholders' Deficit (Details)
Stockholders' Deficit (Details) - USD ($) $ in Thousands | 1 Months Ended | 9 Months Ended | ||
Jun. 30, 2021 | Nov. 30, 2019 | Sep. 30, 2021 | Sep. 30, 2020 | |
Class of Stock [Line Items] | ||||
Net Proceeds | $ 200,440 | $ (86) | ||
Open Market Sale Agreement | ||||
Class of Stock [Line Items] | ||||
Shares issued | 12,830,333 | 12,830,333 | 175,289 | |
Proceeds from issuance of common stock, net | $ 48,400 | $ 48,400 | $ 100 | |
Number of additional shares issued | 99,740,259 | |||
Open Market Sale Agreement | Maximum | ||||
Class of Stock [Line Items] | ||||
Net Proceeds | $ 50,000 | |||
Offering | ||||
Class of Stock [Line Items] | ||||
Shares issued | 59,740,259 | |||
Registered Direct Offering | ||||
Class of Stock [Line Items] | ||||
Shares issued | 40,000,000 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) | Feb. 01, 2020shares | Feb. 29, 2016shares | Dec. 31, 2015 | Sep. 30, 2021itemshares | May 30, 2019shares |
2015 Equity Incentive Plan | |||||
Stock-based compensation | |||||
Expiration period | 10 years | ||||
Automatic annual increase in shares authorized, percent of common stock outstanding | 3.50% | ||||
Shares available for grant | 9,276,073 | ||||
1997 Stock Option Plan | |||||
Stock-based compensation | |||||
Options vested and expected to vest | 2,115,534 | ||||
Inducement Plan | |||||
Stock-based compensation | |||||
Shares available for grant | 735,375 | ||||
Total shares that may be issued | 1,800,000 | ||||
2016 Employee Stock Purchase Plan | |||||
Stock-based compensation | |||||
Shares available for grant | 800,000 | 8,670,753 | |||
Share increase (as a percent) | 1.00% | ||||
Payroll deductions for ESPP participants (as a percent) | 15.00% | ||||
Percentage on share price issued | 85.00% | ||||
Offering period duration | 6 months | ||||
Purchase periods | item | 2 | ||||
Stock issued | 566,573 |
Fair Value Measurements - Recur
Fair Value Measurements - Recurring (Details) - USD ($) $ in Thousands | 9 Months Ended | ||
Sep. 30, 2021 | Dec. 31, 2020 | Nov. 09, 2020 | |
Fair Value Measurements | |||
Cash and cash equivalents | $ 46,211 | $ 18,005 | |
Marketable securities | 154,921 | ||
Derivative assets | 236 | 1,886 | |
Derivative liabilities | 317,304 | 62,119 | |
Energy Capital Facility | |||
Fair Value Measurements | |||
Derivative liabilities | 91,100 | $ 4,200 | |
Recurring | Embedded conversion option | 2023 Notes | |||
Fair Value Measurements | |||
Derivative liabilities | 9,492 | 622 | |
Recurring | Embedded conversion option | 2025 Notes | |||
Fair Value Measurements | |||
Derivative liabilities | 112,085 | 15,850 | |
Recurring | Embedded conversion option | PHC Notes | |||
Fair Value Measurements | |||
Derivative liabilities | 195,727 | 45,647 | |
Recurring | Call Option | Masters Capital | |||
Fair Value Measurements | |||
Derivative liabilities | 23,479 | ||
Recurring | Money market funds | |||
Fair Value Measurements | |||
Cash and cash equivalents | 43,818 | 3 | |
Recurring | Corporate debt securities | |||
Fair Value Measurements | |||
Marketable securities | 40,085 | ||
Recurring | Commercial paper | |||
Fair Value Measurements | |||
Marketable securities | 62,336 | ||
Recurring | Government and agency securities | |||
Fair Value Measurements | |||
Marketable securities | 20,050 | ||
Recurring | PHC Option | |||
Fair Value Measurements | |||
Derivative assets | 236 | 1,886 | |
Recurring | Put Or Call Option | Energy Capital Facility | |||
Fair Value Measurements | |||
Derivative liabilities | 91,097 | 16,255 | |
Recurring | Level 1 | Money market funds | |||
Fair Value Measurements | |||
Cash and cash equivalents | 43,818 | 3 | |
Recurring | Level 1 | Government and agency securities | |||
Fair Value Measurements | |||
Marketable securities | 20,050 | ||
Recurring | Level 2 | Embedded conversion option | 2025 Notes | |||
Fair Value Measurements | |||
Derivative liabilities | 112,085 | 15,850 | |
Recurring | Level 2 | Corporate debt securities | |||
Fair Value Measurements | |||
Marketable securities | 40,085 | ||
Recurring | Level 2 | Commercial paper | |||
Fair Value Measurements | |||
Marketable securities | 62,336 | ||
Recurring | Level 3 | |||
Reconciliation of items measured at fair value on a recurring basis that used significant unobservable inputs (Level 3) | |||
Balance at the beginning of the period | 84,117 | ||
Conversion of financial instruments | (19,973) | ||
Loss on fair value adjustment of option | 74,848 | ||
Loss on change in fair value of derivatives | 158,951 | ||
Gain on extinguishment of option | (3,513) | ||
Financial asset impairment cost | 1,650 | ||
Balance at the end of the period | 296,080 | ||
Recurring | Level 3 | Embedded conversion option | 2023 Notes | |||
Fair Value Measurements | |||
Derivative liabilities | 9,492 | 622 | |
Recurring | Level 3 | Embedded conversion option | PHC Notes | |||
Fair Value Measurements | |||
Derivative liabilities | 195,727 | 45,647 | |
Recurring | Level 3 | Call Option | Masters Capital | |||
Fair Value Measurements | |||
Derivative liabilities | 23,479 | ||
Recurring | Level 3 | PHC Option | |||
Fair Value Measurements | |||
Derivative assets | 236 | 1,886 | |
Recurring | Level 3 | Put Or Call Option | Energy Capital Facility | |||
Fair Value Measurements | |||
Derivative liabilities | $ 91,097 | $ 16,255 |
Fair Value Measurements - Valua
Fair Value Measurements - Valuation Assumptions (Details) - Recurring - Level 3 | Sep. 30, 2021 |
2023 Notes | Risky (bond) rate | |
Fair value valuation assumptions | |
Embedded Derivative Liability, Measurement Input | 0.300 |
2023 Notes | Stock price volatility | |
Fair value valuation assumptions | |
Embedded Derivative Liability, Measurement Input | 0.950 |
2023 Notes | Probabilities of conversion provisions | Minimum | |
Fair value valuation assumptions | |
Embedded Derivative Liability, Measurement Input | 0.050 |
2023 Notes | Probabilities of conversion provisions | Maximum | |
Fair value valuation assumptions | |
Embedded Derivative Liability, Measurement Input | 0.900 |
2023 Notes | Time period until maturity | Minimum | |
Fair value valuation assumptions | |
Embedded Derivative Liability, Measurement Input | 0.50 |
2023 Notes | Time period until maturity | Maximum | |
Fair value valuation assumptions | |
Embedded Derivative Liability, Measurement Input | 1.34 |
PHC Notes | Risky (bond) rate | |
Fair value valuation assumptions | |
Embedded Derivative Liability, Measurement Input | 0.150 |
PHC Notes | Stock price volatility | |
Fair value valuation assumptions | |
Embedded Derivative Liability, Measurement Input | 0.950 |
PHC Notes | Probabilities of conversion provisions | Minimum | |
Fair value valuation assumptions | |
Embedded Derivative Liability, Measurement Input | 0.050 |
PHC Notes | Probabilities of conversion provisions | Maximum | |
Fair value valuation assumptions | |
Embedded Derivative Liability, Measurement Input | 0.750 |
PHC Notes | Time period until maturity | Minimum | |
Fair value valuation assumptions | |
Embedded Derivative Liability, Measurement Input | 0.50 |
PHC Notes | Time period until maturity | Maximum | |
Fair value valuation assumptions | |
Embedded Derivative Liability, Measurement Input | 3.08 |
Income Taxes - Tax Provision (D
Income Taxes - Tax Provision (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Income Taxes | ||
Income tax provision | $ 0 | $ 0 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Dec. 31, 2020 | |
Related party transactions | |||||
Revenue | $ 3,256 | $ 253 | $ 8,471 | $ 303 | |
Due from related party | 3,549 | 3,549 | $ 2,421 | ||
Ascensia | |||||
Related party transactions | |||||
Revenue | 8,500 | ||||
Due from related party | 3,500 | 3,500 | |||
Replacement obligations | $ 1,700 | $ 1,700 |
Reclassification of Prior Yea_2
Reclassification of Prior Year Presentation (Details) - USD ($) | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Reclassification [Line Items] | ||
Inventory | $ 2,597,000 | $ (12,645,000) |
Revision of Prior Period, Reclassification, Adjustment | ||
Reclassification [Line Items] | ||
Provision for inventory obsolescence and net realizable value | (9,441,000) | |
Inventory | $ (9,441,000) |
Subsequent Events - (Details)
Subsequent Events - (Details) - Open Market Sale Agreement - Subsequent Event $ in Millions | 1 Months Ended |
Nov. 30, 2021USD ($) | |
Subsequent Event [Line Items] | |
Maximum offering price under sales agreement | $ 150 |
Commission rate (as a percentage) | 3.00% |