QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification Number) |
Title of Each Class | Trading Symbol | Name of Each Exchange on Which Registered | ||||||
☒ | Accelerated filer | ☐ | ||||||||||||
Non-accelerated filer | ☐ | Smaller reporting company | ||||||||||||
Emerging growth company |
Page No. | |||||
Condensed Consolidated Balance Sheets as of September 30, 2021 and December 31, 2020 | |||||
Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2021 and 2020 | |||||
Condensed Consolidated Statements of Comprehensive Loss for the Three and Nine Months Ended September 30, 2021 and 2020 | |||||
Condensed Consolidated Statements of Stockholders’ Equity for the Three and Nine Months Ended September 30, 2021 and 2020 | |||||
Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2021 and 2020 | |||||
September 30, 2021 | December 31, 2020 | ||||||||||
Assets | |||||||||||
Current assets: | |||||||||||
Cash and cash equivalents | $ | $ | |||||||||
Marketable securities | |||||||||||
Accounts receivable | |||||||||||
Inventory | |||||||||||
Prepaid and other current assets | |||||||||||
Total current assets | |||||||||||
Property and equipment, net | |||||||||||
Operating leases right-of-use assets | |||||||||||
Intangible assets, net | |||||||||||
Goodwill | |||||||||||
Restricted cash | |||||||||||
Other assets | |||||||||||
Total assets | $ | $ | |||||||||
Liabilities and stockholders’ equity | |||||||||||
Current liabilities: | |||||||||||
Accounts payable | $ | $ | |||||||||
Accrued compensation | |||||||||||
Accrued and other liabilities | |||||||||||
Refund liability - CMS advance payment (Note 1) | |||||||||||
Total current liabilities | |||||||||||
Deferred tax liability | |||||||||||
Common stock warrant liability | |||||||||||
Deferred payments for intangible assets | |||||||||||
Operating lease liability, less current portion | |||||||||||
Other liabilities | |||||||||||
Total liabilities | |||||||||||
Commitments and contingencies (Note 9) | |||||||||||
Stockholders’ equity: | |||||||||||
Preferred stock: $ | |||||||||||
Common stock: $ | |||||||||||
Additional paid-in capital | |||||||||||
Accumulated other comprehensive loss | ( | ( | |||||||||
Accumulated deficit | ( | ( | |||||||||
Total stockholders’ equity | |||||||||||
Total liabilities and stockholders’ equity | $ | $ |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||||||||||
Revenue: | |||||||||||||||||||||||
Testing services revenue | $ | $ | $ | $ | |||||||||||||||||||
Product revenue | |||||||||||||||||||||||
Digital and other revenue | |||||||||||||||||||||||
Total revenue | |||||||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||
Cost of testing services | |||||||||||||||||||||||
Cost of product | |||||||||||||||||||||||
Cost of digital and other | |||||||||||||||||||||||
Research and development | |||||||||||||||||||||||
Sales and marketing | |||||||||||||||||||||||
General and administrative | |||||||||||||||||||||||
Total operating expenses | |||||||||||||||||||||||
Loss from operations | ( | ( | ( | ( | |||||||||||||||||||
Other income (expense): | |||||||||||||||||||||||
Interest income, net | |||||||||||||||||||||||
Change in estimated fair value of common stock warrant liability | ( | ||||||||||||||||||||||
CARES Act Provider Relief Fund | |||||||||||||||||||||||
Other expense, net | ( | ( | ( | ( | |||||||||||||||||||
Total other (expense) income | ( | ( | ( | ||||||||||||||||||||
Loss before income taxes | ( | ( | ( | ( | |||||||||||||||||||
Income tax benefit | |||||||||||||||||||||||
Net loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||
Net loss per share (Note 3): | |||||||||||||||||||||||
Basic | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||
Diluted | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||
Weighted-average shares used to compute net loss per share: | |||||||||||||||||||||||
Basic | |||||||||||||||||||||||
Diluted |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||||||||||
Net loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||
Other comprehensive income (loss): | |||||||||||||||||||||||
Foreign currency translation adjustments, net of tax | ( | ( | |||||||||||||||||||||
Net comprehensive loss | $ | ( | $ | ( | $ | ( | $ | ( |
Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total Stockholders’ Equity | |||||||||||||||||||||||||||||||
Shares | Amount | ||||||||||||||||||||||||||||||||||
Balance at December 31, 2020 | $ | $ | $ | ( | $ | ( | $ | ||||||||||||||||||||||||||||
Issuance of common shares through public equity offering, net of commissions and offering costs of $ | — | — | |||||||||||||||||||||||||||||||||
Issuance of common stock under ESPP | — | — | — | ||||||||||||||||||||||||||||||||
RSU settlements, net of shares withheld | — | ( | — | — | ( | ||||||||||||||||||||||||||||||
Issuance of common stock for services | — | — | — | ||||||||||||||||||||||||||||||||
Issuance of common stock for cash upon exercise of stock options | — | — | — | ||||||||||||||||||||||||||||||||
Employee stock-based compensation expense | — | — | — | — | |||||||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | ( | — | ( | |||||||||||||||||||||||||||||
Net loss | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||
Balance at March 31, 2021 | ( | ( | |||||||||||||||||||||||||||||||||
RSU settlements, net of shares withheld | — | ( | — | — | ( | ||||||||||||||||||||||||||||||
Issuance of common stock for services | — | — | — | ||||||||||||||||||||||||||||||||
Issuance of common stock for cash upon exercise of stock options | — | — | — | ||||||||||||||||||||||||||||||||
Issuance of common stock for cash upon exercise of warrants | — | — | — | ||||||||||||||||||||||||||||||||
Employee stock-based compensation expense | — | — | — | — | |||||||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | |||||||||||||||||||||||||||||||
Net loss | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||
Balance at June 30, 2021 | ( | ( | |||||||||||||||||||||||||||||||||
Issuance of common stock under ESPP | — | — | — | ||||||||||||||||||||||||||||||||
RSU settlements, net of shares withheld | — | ( | — | — | ( | ||||||||||||||||||||||||||||||
Issuance of common stock for services | — | — | — | ||||||||||||||||||||||||||||||||
Issuance of common stock for cash upon exercise of stock options | — | — | |||||||||||||||||||||||||||||||||
Employee stock-based compensation expense | — | — | — | ||||||||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | ( | — | ( | |||||||||||||||||||||||||||||
Net loss | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||
Balance at September 30, 2021 | $ | $ | $ | ( | $ | ( | $ |
Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total Stockholders’ Equity | |||||||||||||||||||||||||||||||
Shares | Amount | ||||||||||||||||||||||||||||||||||
Balance at December 31, 2019 | $ | $ | $ | ( | $ | ( | $ | ||||||||||||||||||||||||||||
Issuance of common stock under ESPP | — | — | — | ||||||||||||||||||||||||||||||||
RSU settlements, net of shares withheld | — | ( | — | — | ( | ||||||||||||||||||||||||||||||
Issuance of common stock for services | — | — | — | ||||||||||||||||||||||||||||||||
Issuance of common stock for cash upon exercise of stock options | — | — | — | ||||||||||||||||||||||||||||||||
Issuance of common stock for cash upon exercise of warrants | — | — | — | ||||||||||||||||||||||||||||||||
Employee stock-based compensation expense | — | — | — | — | |||||||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | ( | — | ( | |||||||||||||||||||||||||||||
Net loss | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||
Balance at March 31, 2020 | $ | $ | $ | ( | $ | ( | $ | ||||||||||||||||||||||||||||
Issuance of common shares through public equity offering, net of commissions and offering costs of $ | — | — | |||||||||||||||||||||||||||||||||
Issuance of shares in connection with at-the-market equity offering, net of commissions and offering costs of $ | — | — | |||||||||||||||||||||||||||||||||
RSU settlements, net of shares withheld | — | ( | — | — | ( | ||||||||||||||||||||||||||||||
Issuance of common stock for services | — | — | — | ||||||||||||||||||||||||||||||||
Issuance of common stock for cash upon exercise of stock options | — | — | — | ||||||||||||||||||||||||||||||||
Employee stock-based compensation expense | — | — | — | — | |||||||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | |||||||||||||||||||||||||||||||
Net loss | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||
Balance at June 30, 2020 | $ | $ | $ | ( | $ | ( | $ | ||||||||||||||||||||||||||||
Issuance of common stock under ESPP | — | — | — | ||||||||||||||||||||||||||||||||
RSU settlements, net of shares withheld | — | ( | — | — | ( | ||||||||||||||||||||||||||||||
Issuance of common stock for services | — | — | — | ||||||||||||||||||||||||||||||||
Issuance of common stock for cash upon exercise of stock options | — | — | — | ||||||||||||||||||||||||||||||||
Issuance of common stock upon exercise of warrants | — | — | — | ||||||||||||||||||||||||||||||||
Employee stock-based compensation expense | — | — | — | ||||||||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | |||||||||||||||||||||||||||||||
Net loss | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||
Balance at September 30, 2020 | $ | $ | $ | ( | $ | ( | $ |
Nine Months Ended September 30, | |||||||||||
2021 | 2020 | ||||||||||
Operating activities: | |||||||||||
Net loss | $ | ( | $ | ( | |||||||
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | |||||||||||
Stock-based compensation | |||||||||||
Revaluation of common stock warrant liability to estimated fair value | ( | ||||||||||
Depreciation and amortization | |||||||||||
Amortization of right-of-use assets | |||||||||||
Unrealized loss on long-term marketable equity securities | |||||||||||
Revaluation of contingent consideration to estimated fair value | ( | ||||||||||
Amortization of premium on short-term marketable securities, net | |||||||||||
Changes in operating assets and liabilities: | |||||||||||
Accounts receivable | ( | ( | |||||||||
Inventory | ( | ( | |||||||||
Prepaid and other assets | ( | ( | |||||||||
Operating leases liabilities, net | ( | ( | |||||||||
Accounts payable | |||||||||||
Accrued compensation | |||||||||||
Accrued and other liabilities | |||||||||||
Refund liability - CMS advance payment | ( | ||||||||||
Change in deferred taxes | ( | ( | |||||||||
Net cash (used in) provided by operating activities | ( | ||||||||||
Investing activities: | |||||||||||
Acquisition of business, net of cash acquired | ( | ||||||||||
Acquisition of intangible assets | ( | ( | |||||||||
Purchases of long-term marketable securities | ( | ||||||||||
Maturities of short-term marketable securities | |||||||||||
Additions of capital expenditures, net | ( | ( | |||||||||
Net cash provided by (used in) investing activities | ( | ||||||||||
Financing activities: | |||||||||||
Proceeds from issuance of common shares in public equity offering, net of issuance costs paid | |||||||||||
Proceeds from issuance of common shares in "at-the-market" equity offering, net of issuance costs paid | |||||||||||
Proceeds from issuance of common stock under employee stock purchase plan | |||||||||||
Taxes paid related to net share settlement of restricted stock units | ( | ( | |||||||||
Proceeds from exercise of warrants | |||||||||||
Proceeds from exercise of stock options | |||||||||||
Principal payments on finance lease obligations | ( | ( | |||||||||
Net cash provided by financing activities | |||||||||||
Effect of exchange rate changes on cash and cash equivalents | ( | ||||||||||
Net increase in cash, cash equivalents and restricted cash | |||||||||||
Cash, cash equivalents, and restricted cash at beginning of period | |||||||||||
Cash, cash equivalents, and restricted cash at end of period | $ | $ |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||||||||||
Numerator: | |||||||||||||||||||||||
Net loss used to compute basic and diluted net loss per share | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||
Denominator: | |||||||||||||||||||||||
Weighted-average shares used to compute basic and diluted net loss per share | |||||||||||||||||||||||
Net loss per share: | |||||||||||||||||||||||
Basic and diluted | $ | ( | $ | ( | $ | ( | $ | ( |
Three and Nine Months Ended September 30, | |||||||||||
2021 | 2020 | ||||||||||
Shares of common stock subject to outstanding options | |||||||||||
Shares of common stock subject to outstanding common stock warrants | |||||||||||
Restricted stock units | |||||||||||
Total common stock equivalents |
September 30, 2021 | |||||||||||||||||||||||
Fair Value Measured Using | |||||||||||||||||||||||
(Level 1) | (Level 2) | (Level 3) | Total Balance | ||||||||||||||||||||
Assets | |||||||||||||||||||||||
Cash equivalents: | |||||||||||||||||||||||
Money market funds | $ | $ | $ | $ | |||||||||||||||||||
Long-term marketable securities: | |||||||||||||||||||||||
Corporate equity securities | |||||||||||||||||||||||
Corporate debt securities | |||||||||||||||||||||||
Total | $ | $ | $ | $ | |||||||||||||||||||
Liabilities | |||||||||||||||||||||||
Common stock warrant liability | $ | $ | $ | $ |
December 31, 2020 | |||||||||||||||||||||||
Fair Value Measured Using | |||||||||||||||||||||||
(Level 1) | (Level 2) | (Level 3) | Total Balance | ||||||||||||||||||||
Assets | |||||||||||||||||||||||
Cash equivalents: | |||||||||||||||||||||||
Money market funds | $ | $ | $ | $ | |||||||||||||||||||
Liabilities | |||||||||||||||||||||||
Common stock warrant liability | $ | $ | $ | $ |
(Level 3) | |||||
Common Stock Warrant Liability | |||||
Balance as of December 31, 2020 | $ | ||||
Exercise of warrants | ( | ||||
Change in estimated fair value | ( | ||||
Balance as of September 30, 2021 | $ |
September 30, 2021 | December 31, 2020 | ||||||||||
Private Placement Common Stock Warrant Liability | |||||||||||
Stock Price | $ | $ | |||||||||
Exercise Price | $ | $ | |||||||||
Remaining term (in years) | |||||||||||
Volatility | % | % | |||||||||
Risk-free interest rate | % | % |
September 30, 2021 | December 31, 2020 | September 30, 2020 | December 31, 2019 | ||||||||||||||||||||
Cash and cash equivalents | $ | $ | $ | $ | |||||||||||||||||||
Restricted cash | |||||||||||||||||||||||
Total cash, cash equivalents, and restricted cash at the end of the period | $ | $ | $ | $ |
September 30, 2021 | |||||||||||||||||
Amortized Cost | Unrealized Holding Gains (Losses) | Fair Value | |||||||||||||||
Short-term marketable securities: | |||||||||||||||||
Corporate debt securities | $ | $ | ( | $ | |||||||||||||
Total short-term marketable securities | ( | ||||||||||||||||
Long-term marketable securities: | |||||||||||||||||
Corporate equity securities | ( | ||||||||||||||||
Corporate debt securities | |||||||||||||||||
Total long-term marketable securities | ( | ||||||||||||||||
Total | $ | $ | ( | $ |
December 31, 2020 | |||||||||||||||||
Amortized Cost | Unrealized Holding Losses | Fair Value | |||||||||||||||
Short-term marketable securities: | |||||||||||||||||
Corporate debt securities | $ | $ | ( | $ | |||||||||||||
Total short-term marketable securities | $ | $ | ( | $ |
September 30, 2021 | December 31, 2020 | ||||||||||
Within one year | $ | $ | |||||||||
After one year through five years | |||||||||||
Total | $ | $ | |||||||||
September 30, 2021 | |||||||||||||||||||||||||||||
Gross Carrying Amount | Accumulated Amortization | Foreign Currency Translation | Net Carrying Amount | Weighted Average Remaining Useful Life (In Years) | |||||||||||||||||||||||||
Intangible assets with finite lives: | |||||||||||||||||||||||||||||
Acquired and developed technology | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||
Customer relationships | ( | ( | |||||||||||||||||||||||||||
Commercialization rights | ( | ||||||||||||||||||||||||||||
Trademarks and tradenames | ( | ( | |||||||||||||||||||||||||||
Other | ( | ||||||||||||||||||||||||||||
Total intangible assets with finite lives | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||
Acquired in-process technology | — | — | |||||||||||||||||||||||||||
Total intangible assets | $ | $ | ( | $ | ( | $ |
December 31, 2020 | |||||||||||||||||||||||||||||
Gross Carrying Amount | Accumulated Amortization | Foreign Currency Translation | Net Carrying Amount | Weighted Average Remaining Useful Life (In Years) | |||||||||||||||||||||||||
Intangible assets with finite lives: | |||||||||||||||||||||||||||||
Acquired and developed technology | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||
Customer relationships | ( | ( | |||||||||||||||||||||||||||
Commercialization rights | ( | ||||||||||||||||||||||||||||
Trademarks and tradenames | ( | ( | |||||||||||||||||||||||||||
Total intangible assets with finite lives | $ | $ | ( | $ | ( | $ | |||||||||||||||||||||||
Acquired in-process technology | — | — | |||||||||||||||||||||||||||
Total intangible assets | $ | $ | ( | $ | ( | $ |
Years Ending December 31, | Cost of Testing Services | Cost of Product | Cost of Digital and Other | Sales and Marketing | Total | |||||||||||||||||||||||||||
Remainder of 2021 | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||
2022 | ||||||||||||||||||||||||||||||||
2023 | ||||||||||||||||||||||||||||||||
2024 | ||||||||||||||||||||||||||||||||
2025 | ||||||||||||||||||||||||||||||||
Thereafter | ||||||||||||||||||||||||||||||||
Total future amortization expense | $ | $ | $ | $ | $ |
September 30, 2021 | December 31, 2020 | ||||||||||
Finished goods | $ | $ | |||||||||
Work in progress | |||||||||||
Raw materials | |||||||||||
Total inventory | $ | $ |
September 30, 2021 | December 31, 2020 | ||||||||||
Clinical studies | $ | $ | |||||||||
Short-term lease liability | |||||||||||
Deferred revenue | |||||||||||
Professional fees | |||||||||||
Deferred payments for intangible assets | |||||||||||
Capital expenditures | |||||||||||
Accrued royalty | |||||||||||
Test sample processing fees | |||||||||||
Contingent consideration | |||||||||||
Other accrued expenses | |||||||||||
Total accrued and other liabilities | $ | $ |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||||||||||
Operating lease cost | $ | $ | $ | $ | |||||||||||||||||||
Finance lease cost | |||||||||||||||||||||||
Total lease cost | $ | $ | $ | $ |
September 30, 2021 | |||||
Other information: | |||||
Weighted-average remaining lease term - Operating leases (in years) | |||||
Weighted-average remaining lease term - Finance leases (in years) | |||||
Weighted-average discount rate - Operating leases (%) | % | ||||
Weighted-average discount rate - Finance leases (%) | % |
Year Ending December 31, | Operating Leases | ||||
Remainder of 2021 | $ | ||||
2022 | |||||
2023 | |||||
2024 | |||||
2025 | |||||
Thereafter | |||||
Total lease payments | |||||
Less imputed interest | |||||
Present value of future minimum lease payments | |||||
Less operating lease liability, current portion | |||||
Operating lease liability, long-term portion | $ |
Classified as | Original Term | Exercise Price | Number of Shares Underlying Warrants | ||||||||||||||||||||
Original issue date: | |||||||||||||||||||||||
April 2016 | Liability | $ | |||||||||||||||||||||
Shares Available for Grant | Stock Options Outstanding | Weighted- Average Exercise Price | Number of RSU Shares | Weighted- Average Grant Date Fair Value | |||||||||||||||||||||||||
Balance—December 31, 2020 | $ | $ | |||||||||||||||||||||||||||
Additional shares authorized | — | — | — | — | |||||||||||||||||||||||||
Common stock awards for services | ( | — | — | — | — | ||||||||||||||||||||||||
RSUs granted | ( | — | — | ||||||||||||||||||||||||||
RSUs vested | — | — | — | ( | |||||||||||||||||||||||||
Options granted | ( | — | — | ||||||||||||||||||||||||||
Options exercised | — | ( | — | — | |||||||||||||||||||||||||
Repurchase of common stock under employee incentive plans | — | — | — | — | |||||||||||||||||||||||||
RSUs forfeited | — | — | ( | ||||||||||||||||||||||||||
Options forfeited | ( | — | — | ||||||||||||||||||||||||||
Options expired | ( | — | — | ||||||||||||||||||||||||||
Balance—September 30, 2021 | $ | $ |
Number of Shares Issued (In thousands) | Weighted-Average Exercise Price | Weighted-Average Remaining Contractual Life (Years) | Aggregate Intrinsic Value (In thousands) | ||||||||||||||||||||
Vested | $ | $ | |||||||||||||||||||||
Expected to vest | |||||||||||||||||||||||
Total | $ |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||||||||||||
Employee stock options | ||||||||||||||||||||||||||
Expected term (in years) | ||||||||||||||||||||||||||
Expected volatility | ||||||||||||||||||||||||||
Risk-free interest rate | ||||||||||||||||||||||||||
Expected dividend yield | ||||||||||||||||||||||||||
Employee stock purchase plan | ||||||||||||||||||||||||||
Expected term (in years) | ||||||||||||||||||||||||||
Expected volatility | ||||||||||||||||||||||||||
Risk-free interest rate | ||||||||||||||||||||||||||
Expected dividend yield |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||||||||||
Cost of testing services | $ | $ | $ | $ | |||||||||||||||||||
Cost of product | |||||||||||||||||||||||
Cost of digital and other | |||||||||||||||||||||||
Research and development | |||||||||||||||||||||||
Sales and marketing | |||||||||||||||||||||||
General and administrative | |||||||||||||||||||||||
Total | $ | $ | $ | $ |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
2021 | 2020 | 2021 | 2020 | ||||||||||||||||||||
Testing services revenue | |||||||||||||||||||||||
United States | $ | $ | $ | $ | |||||||||||||||||||
Rest of World | |||||||||||||||||||||||
$ | $ | $ | $ | ||||||||||||||||||||
Product revenue | |||||||||||||||||||||||
United States | $ | $ | $ | $ | |||||||||||||||||||
Europe | |||||||||||||||||||||||
Rest of World | |||||||||||||||||||||||
$ | $ | $ | $ | ||||||||||||||||||||
Digital and other revenue | |||||||||||||||||||||||
United States | $ | $ | $ | $ | |||||||||||||||||||
Europe | |||||||||||||||||||||||
Rest of World | |||||||||||||||||||||||
$ | $ | $ | $ | ||||||||||||||||||||
Total United States | $ | $ | $ | $ | |||||||||||||||||||
Total Europe | $ | $ | $ | $ | |||||||||||||||||||
Total Rest of World | $ | $ | $ | $ | |||||||||||||||||||
Total | $ | $ | $ | $ |
September 30, 2021 | December 31, 2020 | ||||||||||
Long-lived assets: | |||||||||||
United States | $ | $ | |||||||||
Europe | |||||||||||
Rest of World | |||||||||||
Total | $ | $ |
Three Months Ended September 30, | |||||||||||||||||
2021 | 2020 | Change | |||||||||||||||
Revenue: | |||||||||||||||||
Testing services revenue | $ | 66,464 | $ | 45,529 | $ | 20,935 | |||||||||||
Product revenue | 6,521 | 5,383 | 1,138 | ||||||||||||||
Digital and other revenue | 2,604 | 2,457 | 147 | ||||||||||||||
Total revenue | 75,589 | 53,369 | 22,220 | ||||||||||||||
Operating expenses: | |||||||||||||||||
Cost of testing services | 18,038 | 11,900 | 6,138 | ||||||||||||||
Cost of product | 4,919 | 3,705 | 1,214 | ||||||||||||||
Cost of digital and other | 1,879 | 1,210 | 669 | ||||||||||||||
Research and development | 19,439 | 12,474 | 6,965 | ||||||||||||||
Sales and marketing | 21,370 | 13,870 | 7,500 | ||||||||||||||
General and administrative | 18,671 | 13,117 | 5,554 | ||||||||||||||
Total operating expenses | 84,316 | 56,276 | 28,040 | ||||||||||||||
Loss from operations | (8,727) | (2,907) | (5,820) | ||||||||||||||
Other income (expense): | |||||||||||||||||
Interest income, net | 20 | 29 | (9) | ||||||||||||||
Change in estimated fair value of common stock warrant liability | 88 | 79 | 9 | ||||||||||||||
Other expense, net | (3,440) | (254) | (3,186) | ||||||||||||||
Total other expense | (3,332) | (146) | (3,186) | ||||||||||||||
Loss before income taxes | (12,059) | (3,053) | (9,006) | ||||||||||||||
Income tax benefit | 162 | 235 | (73) | ||||||||||||||
Net loss | $ | (11,897) | $ | (2,818) | $ | (9,079) |
Nine Months Ended September 30, | |||||||||||||||||
2021 | 2020 | Change | |||||||||||||||
Revenue: | |||||||||||||||||
Testing services revenue | $ | 190,635 | $ | 113,264 | $ | 77,371 | |||||||||||
Product revenue | 19,160 | 13,369 | 5,791 | ||||||||||||||
Digital and other revenue | 7,382 | 6,917 | 465 | ||||||||||||||
Total revenue | 217,177 | 133,550 | 83,627 | ||||||||||||||
Operating expenses: | |||||||||||||||||
Cost of testing services | 51,756 | 30,631 | 21,125 | ||||||||||||||
Cost of product | 13,771 | 9,635 | 4,136 | ||||||||||||||
Cost of digital and other | 4,861 | 3,966 | 895 | ||||||||||||||
Research and development | 54,479 | 35,616 | 18,863 | ||||||||||||||
Sales and marketing | 56,421 | 37,727 | 18,694 | ||||||||||||||
General and administrative | 50,216 | 35,436 | 14,780 | ||||||||||||||
Total operating expenses | 231,504 | 153,011 | 78,493 | ||||||||||||||
Loss from operations | (14,327) | (19,461) | 5,134 | ||||||||||||||
Other income (expense): | |||||||||||||||||
Interest income, net | 147 | 146 | 1 | ||||||||||||||
Change in estimated fair value of common stock warrant liability | 50 | (990) | 1,040 | ||||||||||||||
CARES Act Provider Relief Fund | — | 4,813 | (4,813) | ||||||||||||||
Other expense, net | (906) | (572) | (334) | ||||||||||||||
Total other (expense) income | (709) | 3,397 | (4,106) | ||||||||||||||
Loss before income taxes | (15,036) | (16,064) | 1,028 | ||||||||||||||
Income tax benefit | 525 | 865 | (340) | ||||||||||||||
Net loss | $ | (14,511) | $ | (15,199) | $ | 688 |
Nine Months Ended September 30, | |||||||||||
2021 | 2020 | ||||||||||
(in thousands) | |||||||||||
Net cash provided by (used in): | |||||||||||
Operating activities | $ | (23,460) | $ | 26,250 | |||||||
Investing activities | 55,494 | (9,920) | |||||||||
Financing activities | 186,476 | 159,185 | |||||||||
Effect of exchange rate changes on cash, cash equivalents and restricted cash | (157) | 64 | |||||||||
Net increase in cash, cash equivalents and restricted cash | $ | 218,353 | $ | 175,579 |
(a) Total Number of Shares (or Units) Purchased | (b) Average Price Paid per Share (or Unit) | ||||||||||
July 1, 2021 - July 31, 2021 | 18,540 | (1) | $ | 32.38 | |||||||
August 1, 2021 -August 31, 2021 | 16,177 | (1) | 30.45 | ||||||||
September 1, 2021 - September 30, 2021 | 4,971 | (1) | 6.24 | ||||||||
Total | 39,688 | — |
Exhibit Number | ||||||||
3.1(1) | ||||||||
3.2(2) | ||||||||
3.3(3) | ||||||||
4.1(4) | ||||||||
4.2(5)# | ||||||||
4.3(6)# | ||||||||
4.4(7)# | ||||||||
4.5(8)# | ||||||||
4.6(9) | ||||||||
4.7(10)# | ||||||||
10.1(11)# | ||||||||
31.1* | ||||||||
31.2* | ||||||||
32.1** | ||||||||
101.INS* | XBRL Instance Document | |||||||
101.SCH* | XBRL Taxonomy Extension Schema Document | |||||||
101.CAL* | XBRL Taxonomy Extension Calculation Linkbase Document | |||||||
101.DEF* | XBRL Taxonomy Extension Definition Linkbase Document | |||||||
101.LAB* | XBRL Taxonomy Extension Label Linkbase Document | |||||||
101.PRE* | XBRL Taxonomy Extension Presentation Linkbase Document | |||||||
104 | Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101) | |||||||
(1) | Incorporated by reference to Exhibit 3.1 to the Registrant’s Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on August 28, 2014. | |||||||
(2) | Incorporated by reference to Exhibit 3.1 to the Registrant’s Form 8-K filed with the SEC on June 21, 2021. | |||||||
(3) | Incorporated by reference to Exhibit 3.2 to the Registrant’s Form 8-K filed with the SEC on June 21, 2021. | |||||||
(4) | Incorporated by reference to Exhibit 4.1 to the Registrant’s Form 10-K filed with the SEC on March 31, 2015. | |||||||
(5) | Incorporated by reference to Exhibit 4.2 to the Registrant’s Form 10-Q filed with the SEC on July 29, 2021. | |||||||
(6) | Incorporated by reference to Exhibit 99(d)(3) to the Registrant's Form SC TO-I filed with the SEC on October 12, 2017. | |||||||
(7) | Incorporated by reference to Exhibit 4.5 to the Registrant’s Form S-8 filed with the SEC on July 18, 2014. | |||||||
(8) | Incorporated by reference to Exhibit 4.5 to the Registrant’s Form 10-Q filed with the SEC on July 29, 2021. | |||||||
(9) | Incorporated by reference to Exhibit 10.3 to the Registrant’s Form 8-K filed with the SEC on April 14, 2016. | |||||||
(10) | Incorporated by reference to Exhibit 4.7 to the Registrant’s Form 10-Q filed with the SEC on July 29, 2021. | |||||||
(11) | Incorporated by reference to Exhibit 10.1 to the Registrant's Form 8-K filed with the SEC on July 20, 2021. | |||||||
# | Indicates management contract or compensatory plan or arrangement. | |||||||
* | Filed herewith. | |||||||
** | Furnished herewith. |
CAREDX, INC. | ||||||||
(Registrant) | ||||||||
Date: October 28, 2021 | By: | /s/ REGINALD SEETO, MBBS | ||||||
Reginald Seeto, MBBS | ||||||||
President and Chief Executive Officer | ||||||||
(Principal Executive Officer) | ||||||||
By: | /s/ ANKUR DHINGRA | |||||||
Ankur Dhingra | ||||||||
Chief Financial Officer | ||||||||
(Principal Accounting and Financial Officer) |
Date: October 28, 2021 | By: | /s/ Reginald Seeto, MBBS | |||||||||
Reginald Seeto, MBBS | |||||||||||
Chief Executive Officer | |||||||||||
(Principal Executive Officer) |
Date: October 28, 2021 | By: | /s/ Ankur Dhingra | |||||||||
Ankur Dhingra | |||||||||||
Chief Financial Officer | |||||||||||
(Principal Accounting and Financial Officer) |
By: | /s/ Reginald Seeto, MBBS | By: | /s/ Ankur Dhingra | |||||||||||||||||
Reginald Seeto, MBBS | Ankur Dhingra | |||||||||||||||||||
President and Chief Executive Officer | Chief Financial Officer | |||||||||||||||||||
(Principal Executive Officer) | (Principal Accounting and Financial Officer) | |||||||||||||||||||
Date: October 28, 2021 | Date: October 28, 2021 |
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares |
Sep. 30, 2021 |
Dec. 31, 2020 |
---|---|---|
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 52,776,733 | 49,441,166 |
Common stock, shares outstanding (in shares) | 52,776,733 | 49,441,166 |
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2021 |
Sep. 30, 2020 |
Sep. 30, 2021 |
Sep. 30, 2020 |
|
Revenue: | ||||
Total revenue | $ 75,589 | $ 53,369 | $ 217,177 | $ 133,550 |
Operating expenses: | ||||
Research and development | 19,439 | 12,474 | 54,479 | 35,616 |
Sales and marketing | 21,370 | 13,870 | 56,421 | 37,727 |
General and administrative | 18,671 | 13,117 | 50,216 | 35,436 |
Total operating expenses | 84,316 | 56,276 | 231,504 | 153,011 |
Loss from operations | (8,727) | (2,907) | (14,327) | (19,461) |
Other income (expense): | ||||
Interest income, net | 20 | 29 | 147 | 146 |
Change in estimated fair value of common stock warrant liability | 88 | 79 | 50 | (990) |
CARES Act Provider Relief Fund | 0 | 0 | 0 | 4,813 |
Other expense, net | (3,440) | (254) | (906) | (572) |
Total other (expense) income | (3,332) | (146) | (709) | 3,397 |
Loss before income taxes | (12,059) | (3,053) | (15,036) | (16,064) |
Income tax benefit | 162 | 235 | 525 | 865 |
Net loss | $ (11,897) | $ (2,818) | $ (14,511) | $ (15,199) |
Net loss per share (Note 3): | ||||
Basic (in dollars per share) | $ (0.23) | $ (0.06) | $ (0.28) | $ (0.33) |
Diluted (in dollars per share) | $ (0.23) | $ (0.06) | $ (0.28) | $ (0.33) |
Weighted-average shares used to compute net loss per share: | ||||
Basic (in shares) | 52,681,451 | 49,010,680 | 52,034,450 | 45,526,810 |
Diluted (in shares) | 52,681,451 | 49,010,680 | 52,034,450 | 45,526,810 |
Testing services | ||||
Revenue: | ||||
Total revenue | $ 66,464 | $ 45,529 | $ 190,635 | $ 113,264 |
Operating expenses: | ||||
Cost of goods and services | 18,038 | 11,900 | 51,756 | 30,631 |
Product | ||||
Revenue: | ||||
Total revenue | 6,521 | 5,383 | 19,160 | 13,369 |
Operating expenses: | ||||
Cost of goods and services | 4,919 | 3,705 | 13,771 | 9,635 |
Digital And Other | ||||
Revenue: | ||||
Total revenue | 2,604 | 2,457 | 7,382 | 6,917 |
Operating expenses: | ||||
Cost of goods and services | $ 1,879 | $ 1,210 | $ 4,861 | $ 3,966 |
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2021 |
Sep. 30, 2020 |
Sep. 30, 2021 |
Sep. 30, 2020 |
|
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (11,897) | $ (2,818) | $ (14,511) | $ (15,199) |
Other comprehensive income (loss): | ||||
Foreign currency translation adjustments, net of tax | (937) | 962 | (1,997) | 853 |
Net comprehensive loss | $ (12,834) | $ (1,856) | $ (16,508) | $ (14,346) |
Condensed Consolidated Statements of Stockholders' Equity (Parenthetical) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Mar. 31, 2021 |
Jun. 30, 2020 |
|
Public Offering | ||
Common stock, commissions and offering costs | $ 12,495 | $ 9,166 |
At The Market Equity Offering | ||
Common stock, commissions and offering costs | $ 785 |
Organization and Description of Business |
9 Months Ended |
---|---|
Sep. 30, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business | ORGANIZATION AND DESCRIPTION OF BUSINESS CareDx, Inc. (“CareDx” or the “Company”), together with its subsidiaries, is a leading precision medicine company focused on the discovery, development and commercialization of clinically differentiated, high-value diagnostic solutions for transplant patients and caregivers. The Company’s headquarters are in South San Francisco, California. The primary operations are in Brisbane, California; Omaha, Nebraska; Fremantle, Australia; and Stockholm, Sweden. The Company’s commercially available testing services consist of AlloSure® Kidney, which is a donor-derived cell-free DNA (“dd-cfDNA”) solution for kidney transplant patients, AlloMap® Heart, which is a gene expression solution for heart transplant patients, and AlloSure® Heart, a dd-cfDNA solution for heart transplant patients. The Company has initiated several clinical studies to generate data on its existing and planned future testing services. In April 2020, the Company announced its first biopharma research partnership for AlloCell, a surveillance solution that monitors the level of engraftment and persistence of allogeneic cells for patients who have received cell therapy transplants. The Company also offers high-quality products that increase the chance of successful transplants by facilitating a better match between a donor and a recipient of stem cells and organs. In 2019, the Company began providing digital solutions to transplant centers following the acquisitions of Ottr Complete Transplant Management (“Ottr, Inc.”) and XynManagement, Inc. (“XynManagement”), as well as the acquisition of TransChart LLC (“TransChart”) in 2021. Testing Services AlloSure Kidney has been a covered service for Medicare beneficiaries since October 2017. The Medicare reimbursement rate for AlloSure Kidney is currently $2,841. AlloSure Kidney has received positive coverage decisions from several private payers, including Blue Cross Blue Shield (“BCBS”) of South Carolina, BCBS of Kansas City and Capital Health, and is reimbursed by other private payers on a case-by-case basis. AlloMap Heart has been a covered service for Medicare beneficiaries since January 2006. The Medicare reimbursement rate for AlloMap Heart is currently $3,240. AlloMap Heart has also received positive coverage decisions for reimbursement from many of the largest U.S. private payers, including Aetna, Cigna, Health Care Services Corporation, Humana, Kaiser Foundation Health Plan, Inc. and UnitedHealthcare. In October 2020, AlloSure Heart received a final Palmetto MolDx Medicare coverage decision for AlloSure Heart. In November 2020, Noridian Healthcare Solutions, the Company's Medicare Administrative Contractor, issued a parallel coverage policy granting coverage when used in conjunction with AlloMap Heart, which became effective in December 2020. The Medicare reimbursement rate for AlloSure Heart is currently $2,753. In May 2021, the Company purchased a minority investment of common stock in the biotechnology company Miromatrix Medical, Inc. (“Miromatrix”), for $5.0 million, and the investment is marked to market. Miromatrix works to eliminate the need for an organ transplant waiting list through the development of implantable engineered biological organs. Clinical Studies In January 2018, the Company initiated the Kidney Allograft Outcomes AlloSure Kidney Registry study (“K-OAR”), to develop additional data on the clinical utility of AlloSure Kidney for surveillance of kidney transplant recipients. K-OAR is a multicenter, non-blinded, prospective observational cohort study which has enrolled more than 1,700 renal transplant patients who will receive AlloSure Kidney long-term surveillance. In September 2018, the Company initiated the Surveillance HeartCare™ Outcomes Registry (“SHORE”). SHORE is a prospective, multi-center, observational registry of patients receiving HeartCare for surveillance. HeartCare combines the gene expression profiling technology of AlloMap Heart with the dd-cfDNA analysis of AlloSure® Heart in one surveillance solution. In February 2019, AlloSure® Lung became available for lung transplant patients through a compassionate use program while the test is undergoing further studies. In June 2020, the Company submitted an AlloSure Lung application to the Palmetto MolDx Technical Assessment program seeking coverage and reimbursement for Medicare beneficiaries. In September 2019, the Company announced the commencement of the Outcomes of KidneyCare on Renal Allografts (“OKRA”) study, which is an extension of K-OAR. OKRA is a prospective, multi-center, observational, registry of patients receiving KidneyCare for surveillance. KidneyCare combines the dd-cfDNA analysis of AlloSure Kidney with the gene expression profiling technology of AlloMap Kidney and the predictive artificial intelligence technology of KidneyCare iBox for a multimodality surveillance solution. The Company has not yet made any applications to private payers for reimbursement coverage of AlloMap Kidney or KidneyCare. Products The Company’s suite of AlloSeq products are commercial next generation sequencing (“NGS”)-based kitted solutions that the Company has developed as a result of its license agreement with Illumina, Inc. (“Illumina”). These products include: AlloSeq™ Tx, a high-resolution Human Leukocyte Antigen (“HLA”) typing solution, AlloSeq™ cfDNA, a surveillance solution designed to measure dd-cfDNA in blood to detect active rejection in transplant recipients, and AlloSeq™ HCT, a solution for chimerism testing for stem cell transplant recipients. The Company's other HLA typing products include: TruSight HLA, a NGS-based high resolution typing solution; Olerup SSP®, based on the sequence specific primer (“SSP”) technology; and QTYPE®, which uses real-time polymerase chain reaction (“PCR”) methodology, to perform HLA typing at a low to intermediate resolution for samples that require a fast turnaround time. In March 2021, the Company acquired BFS Molecular S.R.L. (“BFS Molecular”), a software company focused on NGS-based patient testing solutions. BFS Molecular brings extensive software and algorithm development capabilities for NGS transplant surveillance products. Digital and Other Following the acquisitions of both Ottr, Inc. and XynManagement, the Company is a leading provider of transplant patient tracking software (“Ottr software”), as well as of transplant quality tracking and waitlist management solutions. Ottr software provides comprehensive solutions for transplant patient management and enables integration with electronic medical record (“EMR”) systems providing patient surveillance management tools and outcomes data to transplant centers. XynManagement provides two unique solutions, XynQAPI software (“XynQAPI”) and XynCare. XynQAPI simplifies transplant quality tracking and Scientific Registry of Transplant Recipients reporting. XynCare includes a team of transplant assistants who maintain regular contact with patients on the waitlist to help prepare for their transplant and maintain eligibility. In September 2020, the Company launched AlloCare, a mobile app that provides a patient-centric resource for transplant recipients to manage medication adherence, coordinate with Patient Care Managers for AlloSure scheduling and measure health metrics. In January 2021, the Company acquired TransChart LLC for cash. TransChart provides EMR software to hospitals throughout the U.S. to care for patients who have or may need an organ transplant. As part of its acquisition of TransChart in January 2021, the Company acquired TxAccess, a cloud-based service that allows nephrologists and dialysis centers to electronically submit referrals to transplant programs, closely follow and assist patients through the transplant waitlist process, and ultimately, through transplantation. In June 2021, the Company acquired the Transplant Hero patient application. The application helps patients manage their medications through alarms and interactive logging of medication events. Also in June 2021, the Company entered into a strategic agreement with OrganX to develop clinical decision support tools across the transplant patient journey. Together, the Company and OrganX will develop advanced analytics that integrate AlloSure, the first transplant specific dd-cfDNA assay, with large transplant databases to provide clinical data solutions. This partnership delivers the next level of innovation beyond multi-modality by incorporating a variety of clinical inputs to create a universal composite scoring system. The Company has agreed to potential future milestone payments. COVID-19 Pandemic On January 30, 2020, the World Health Organization (the “WHO”) announced a global health emergency because of a new strain of coronavirus (“COVID-19”) originating in Wuhan, China and the risks to the international community as the virus spread globally beyond its point of origin. In March 2020, the WHO classified the COVID-19 outbreak as a pandemic, based on the rapid increase in exposure globally. The full impact of the COVID-19 pandemic, including the impact associated with preventative and precautionary measures that the Company, other businesses and governments are taking, continues to evolve as of the date of this report. As such, it is uncertain as to the full magnitude that the pandemic will have on the Company, but the pandemic may materially affect the Company's financial condition, liquidity and future results of operations. In the final weeks of March and during April 2020, with hospitals increasingly caring for COVID-19 patients, hospital administrators chose to limit or even defer, non-emergency procedures. Immunosuppressed transplant patients either self-prescribed or were asked to avoid transplant centers and caregiver visits to reduce the risk of contracting COVID-19. As a result, with transplant surveillance visits down, the Company experienced a slowdown in testing services volumes in the final weeks of March and during April 2020. As a response to the COVID-19 pandemic, and to enable immune-compromised transplant patients to continue to have their blood drawn, in late March 2020, the Company launched RemoTraC, a remote home-based blood draw solution using mobile phlebotomy for AlloSure and AlloMap surveillance tests, as well as for other standard monitoring tests. To date, more than 200 transplant centers can offer RemoTraC to their patients and over 9,000 kidney, heart and lung transplant patients have enrolled. Based on existing and new relationships with partners, the Company has established a nationwide network of more than 10,000 mobile phlebotomists. Following the introduction of RemoTraC and with the easing of stay-at-home restrictions and the opening up of many hospitals to non-COVID-19 patients, the Company’s testing services volumes returned to levels consistent with those experienced immediately prior to the COVID-19 pandemic. In spite of the resurgence of COVID-19 infection rates, which resulted in increased stay-at-home and renewed travel restrictions, the Company did not experience a decrease in testing services volumes. The Company’s product business experienced a reduction in forecasted sales volume throughout the second and third quarters of 2020, as it was unable to undertake onsite discussions and demonstrations of its recently launched NGS products, including AlloSeq Tx 17, which was awarded CE mark authorization in May 2020. The Company's product business maintained normal sales volumes during the fourth quarter of 2020 and increased sales volumes throughout 2021. The Company is maintaining its testing, manufacturing, and distribution facilities while implementing specific protocols to reduce contact among employees. In areas where COVID-19 impacts healthcare operations, the Company’s field-based sales and clinical support teams are supporting providers through virtual platforms. Although the executive orders that placed certain restrictions on operations in San Mateo County and the State of California, where the Company's laboratory and headquarters are located, were lifted effective June 15, 2021, new orders or restrictions may be adopted in the future depending upon the COVID-19 transmission rates in the Company's county and state, as well as other factors. In addition, the Company has created a COVID-19 task force that is responsible for crisis decision making, employee communications, enforcing pre-arrival temperature checking, daily health check-ins and enhanced safety training/protocols in its offices for employees that do not work from home. Liquidity and Capital Resources The Company has incurred significant losses and negative cash flows from operations since its inception and had an accumulated deficit of $367.0 million at September 30, 2021. As of September 30, 2021, the Company had cash, cash equivalents and marketable securities of $363.3 million. CMS Accelerated and Advance Payment Program for Medicare Providers On March 27, 2020 the U.S. government enacted the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). Pursuant to the CARES Act, the Centers for Medicare & Medicaid Services (“CMS”) expanded its Accelerated and Advance Payment Program in order to increase cash flow to providers of services and suppliers impacted by the COVID-19 pandemic. CMS is authorized to provide accelerated or advance payments during the period of the public health emergency to any Medicare provider who submitted a request to the appropriate Medicare Administrative Contractor and met the required qualifications. During April 2020, the Company received an advance payment from CMS of approximately $20.5 million, and recorded the payment as Deferred revenue - CMS advance payment on the Company's condensed consolidated balance sheet. During December 2020, the Company reassessed the Deferred revenue - CMS advance payment and repaid the entire amount in January 2021. The Company recorded the amount as Refund liability - CMS advance payment on the condensed consolidated balance sheet as of December 31, 2020. Refer to Note 8, Balance Sheet Components, for further explanation. CARES Act Provider Relief Fund for Medicare Providers Pursuant to the CARES Act, the U.S. Department of Health & Human Services (“HHS”) distributed an initial tranche of $30.0 billion in funds to healthcare providers that received Medicare fee-for-service (“FFS”) reimbursements in 2019. These payments to healthcare providers are not loans and will not be required to be repaid. As a condition to receiving these payments, providers must agree to certain terms and conditions and submit sufficient documentation demonstrating that the funds are being used for healthcare-related expenses or lost revenue attributable to the COVID-19 pandemic. Due to the recent enactment of legislation and absence of definitive guidance, there is a high degree of uncertainty around the CARES Act’s implementation and the Company continues to assess the impact on its business. Furthermore, HHS has indicated that it, along with the Office of Inspector General, will be closely monitoring and auditing providers to ensure that recipients comply with the terms and conditions of relief programs and to prevent fraud and abuse. All providers will be subject to civil and criminal penalties for any deliberate omissions, misrepresentations or falsifications of any information given to HHS. Providers will be distributed a portion of the initial $30.0 billion of funds based on their share of total Medicare FFS reimbursements made by the U.S. in 2019. During April 2020, the Company received a payment of approximately $4.8 million representing its portion of the initial tranche of funds, recorded in other income (expense), net on the condensed consolidated statements of operations. The Company is complying with the key terms and provisions of the CARES Act Provider Relief Fund, which includes, among other things, the requirement that the Company maintain appropriate records and cost documentation. During the quarter ended September 30, 2021, the Company was notified by HHS that the Provider Relief Fund Reporting Portal was open for reporting on the use of Provider Relief Fund payments, and the Company completed and submitted a report indicating the use of the funds the Company received pursuant to the CARES Act. June 2020 Underwritten Public Offering of Common Stock On June 15, 2020, the Company sold 4,492,187 shares of common stock (which included shares sold pursuant to the underwriters’ full exercise of an overallotment option granted to the underwriters in connection with the offering) through an underwritten public offering at a price of $32.00 per share for aggregate net proceeds of approximately $134.6 million. January 2021 Underwritten Public Offering of Common Stock On January 25, 2021, the Company sold 1,923,077 shares of its common stock through an underwritten public offering at a public offering price of $91.00 per share. The net proceeds to the Company from the offering were approximately $164.0 million, after deducting underwriting discounts and commissions and offering expenses. On February 11, 2021, the Company sold 288,461 shares of its common stock pursuant to the full exercise of the overallotment option granted to the underwriters in connection with the offering. The net proceeds to the Company from the full exercise of the underwriters' overallotment option were approximately $24.7 million.
|
Summary of Significant Accounting Policies |
9 Months Ended |
---|---|
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES The significant accounting policies and estimates used in preparation of the unaudited condensed consolidated financial statements are described in the Company’s audited consolidated financial statements as of and for the year ended December 31, 2020, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. Material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 are reflected below. Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”), and follow the requirements of the Securities and Exchange Commission (the “SEC”) for interim reporting. As permitted under those rules, certain notes and other financial information that are normally required by U.S. GAAP can be condensed or omitted. These unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments that are necessary for a fair statement of the Company’s financial information. The condensed consolidated balance sheet as of December 31, 2020 has been derived from audited consolidated financial statements as of that date but does not include all of the financial information required by U.S. GAAP for complete financial statements. Operating results for the three and nine months ended September 30, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021. Use of Estimates The preparation of unaudited condensed 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 disclosure of contingent assets and liabilities and the reported amounts of revenues and expenses in the unaudited condensed consolidated financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to transaction price estimates used for testing services revenue; standalone fair value of digital revenue performance obligations; accrued expenses for clinical studies; inventory valuation; the fair value of issued common stock warrants and embedded derivatives; the fair value of assets and liabilities acquired in a business combination or an assets acquisition (including identifiable intangible assets acquired); the fair value of contingent consideration recorded in connection with a business combination; the grant date fair value assumptions used to estimate stock-based compensation expense; income taxes; impairment of long-lived assets and indefinite-lived assets (including goodwill); and legal contingencies. Actual results could differ from those estimates. Concentrations of Credit Risk and Other Risks and Uncertainties For the three months ended September 30, 2021 and 2020, approximately 61% and 58%, respectively, of total revenue was derived from Medicare. For the nine months ended September 30, 2021 and 2020, approximately 60% and 56%, respectively, of total revenue was derived from Medicare. As of September 30, 2021 and December 31, 2020, approximately 29% and 28%, respectively, of accounts receivable was due from Medicare. No other payer or customer represented more than 10% of accounts receivable on either September 30, 2021 or December 31, 2020. Marketable Securities The Company considers all highly liquid investments in securities with a maturity of greater than three months at the time of purchase to be marketable securities. As of September 30, 2021, the Company’s short-term marketable securities consisted of corporate debt securities with maturities of greater than three months but less than twelve months at the time of purchase. These short-term marketable securities are classified as current assets on the condensed consolidated balance sheet. The Company classifies its short-term marketable securities as held-to-maturity at the time of purchase and reevaluates such designation at each balance sheet date. The Company has the positive intent and ability to hold these marketable securities to maturity. Short-term marketable securities are carried at amortized cost and are adjusted for amortization of premiums and accretion of discounts to maturity, which is included in interest income (expense), net on the condensed consolidated statements of operations. Realized gains and losses and declines in value judged to be other-than-temporary, if any, on short-term marketable securities are included in interest income (expense), net. The cost of securities sold will be determined using specific identification. The Company considers investments in securities with remaining maturities of over one year as long-term investments. As of September 30, 2021, the Company's long-term marketable securities consisted of corporate equity securities and corporate debt securities. These long-term marketable securities are classified as other assets on the condensed consolidated balance sheet. The Company classifies its long-term marketable debt securities as available-for-sale and reevaluates such designation at each balance sheet date. The Company records its long-term marketable equity securities at fair market value. Unrealized gains and losses from the remeasurement of the long-term marketable equity securities to fair value are included in other expense, net, in the condensed consolidated statements of operations. Realized gains and losses and declines in value judged to be other-than-temporary, if any, on long-term marketable securities are included in interest income, net. Leases Effective January 1, 2019, the Company adopted Accounting Standard Codification (“ASC”) Topic 842, Leases using the optional transition method and applied the standard only to leases that existed at that date. The Company determines if an arrangement is or contains a lease at contract inception. A right-of-use (“ROU”) asset, representing the underlying asset during the lease term, and a lease liability, representing the payment obligation arising from the lease, are recognized on the condensed consolidated balance sheet at lease commencement based on the present value of the payment obligation. For operating leases, expense is recognized on a straight-line basis over the lease term. For finance leases, interest expense on the lease liability is recognized using the effective interest method and amortization of the ROU asset is recognized on a straight-line basis over the shorter of the estimated useful life of the asset or the lease term. Short-term leases with an initial term of 12 months or less are not recorded on the balance sheet. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its incremental borrowing rate. The incremental borrowing rate is determined by using the rate of interest that the Company would pay to borrow on a collateralized basis an amount equal to the lease payments for a similar term and in a similar economic environment. As of September 30, 2021, the Company’s leases had remaining terms of 0.67 years to 7.42 years, some of which include options to extend the lease term. Recent Accounting Pronouncements In October 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2020-10, Codification Improvements, which contains amendments that improve the consistency of the ASC by including all disclosure guidance in the appropriate Disclosure Section (Section 50). The FASB provided transition guidance for all the amendments in this ASU. The amendments in Sections B and C (Section A has been removed) of this ASU are effective for annual periods beginning after December 15, 2020 for public business entities. Early application of the amendments in this ASU is permitted for public business entities for any annual or interim period for which financial statements have not been issued. The amendments in this ASU should be applied retrospectively. The Company adopted the standard on January 1, 2021. The adoption of the new standard did not have an impact on the Company's condensed consolidated financial statements and disclosures. In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (a consensus of the FASB Emerging Issues Task Force), which contains amendments that clarify and reduce diversity in an issuer's accounting for modifications or exchanges of freestanding equity-classified written call options that remain equity classified after modification or exchange. The amendments set forth in this ASU are effective for all entities for annual periods beginning after December 15, 2021. Early application of the amendments in this ASU is permitted for all entities. The amendments in this ASU should be applied prospectively. The Company plans to adopt the standard on January 1, 2022. The Company is in the process of assessing the impact that this new standard will have on its consolidated financial statements and disclosures.
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Net Loss Per Share |
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Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net Loss Per Share | NET LOSS PER SHARE Basic and diluted net loss per share have been computed by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration of common share equivalents as their effect would have been antidilutive. The following tables set forth the computation of the Company’s basic and diluted net loss per share (in thousands, except shares and per share data):
The following potentially dilutive securities have been excluded from diluted net loss per share as of September 30, 2021 and 2020 because their effect would be antidilutive:
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Fair Value Measurements |
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Measurements | FAIR VALUE MEASUREMENTS The Company records its financial assets and liabilities at fair value. The carrying amounts of certain financial instruments of the Company, including cash and cash equivalents, prepaid expenses and other current assets, accounts payable and accrued liabilities, approximate fair value due to their relatively short maturities. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows: •Level 1: Inputs that include quoted prices in active markets for identical assets and liabilities. •Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. •Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. The following table sets forth the Company’s financial assets and liabilities, measured at fair value on a recurring basis, as of September 30, 2021 and December 31, 2020 (in thousands):
The following table presents the issuances, exercises, changes in fair value and reclassifications of the Company’s Level 3 financial instruments that are measured at fair value on a recurring basis (in thousands):
As of September 30, 2021, the Company had one investment in convertible preferred shares carried at cost. In the event the Company had to calculate the fair value of this investment, it would be based on Level 3 inputs. This investment is not considered material to the Company's condensed consolidated financial statements. In determining fair value, the Company uses various valuation approaches within the fair value measurement framework. The valuation methodologies used for the Company’s instruments measured at fair value and their classification in the valuation hierarchy are summarized below: •Money market funds – Investments in money market funds are classified within Level 1. Money market funds are valued at the closing price reported by the fund sponsor from an actively traded exchange. At September 30, 2021 and December 31, 2020, money market funds were included as cash and cash equivalents in the condensed consolidated balance sheets. •Short-term marketable securities – Investments in short-term marketable securities are classified within Level 2. The securities are valued using third-party pricing sources. The pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly. •Long-term marketable equity and debt securities – Investments in long-term marketable equity securities are classified within Level 1. The securities are recorded at fair value based on readily available quoted market prices in active markets. Investments in long-term marketable debt securities are classified within Level 2. The securities are recorded at fair value based on observable inputs for quoted prices for identical or similar assets in markets that are not active. Long-term marketable securities are located within other assets on the condensed consolidated balance sheets. •Common stock warrant liability – Common stock warrant liability is classified within Level 3. The Company utilizes a binomial-lattice pricing model (the “Monte Carlo Simulation Model”) that involves a market condition simulation to estimate the fair value of the warrants. The application of the Monte Carlo Simulation Model requires the use of a number of complex assumptions, including the Company’s stock price, expected life of the warrants, stock price volatility determined from the Company’s historical stock prices and stock prices of peer companies in the diagnostics industry, and risk-free rates based on the implied yield currently available in the U.S. Treasury zero-coupon issues with a remaining term equal to the expected life of the warrants. Increases (decreases) in the assumptions discussed above result in a directionally similar impact to the fair value of the common stock warrant liability. Common Stock Warrant Liability Valuation Assumptions:
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Cash and Marketable Securities |
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Cash and Cash Equivalents [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Cash and Marketable Securities | CASH AND MARKETABLE SECURITIES Cash, Cash Equivalents and Restricted Cash A reconciliation of cash, cash equivalents, and restricted cash reported within the condensed consolidated balance sheets to the amount reported within the condensed consolidated statements of cash flows is shown in the table below (in thousands):
Marketable Securities All short-term marketable securities were considered held-to-maturity at September 30, 2021 and December 31, 2020. As of September 30, 2021 and December 31, 2020, some of the Company’s short-term marketable securities were in an unrealized loss position. The Company determined that it had the positive intent and ability to hold until maturity all short-term marketable securities that have been in a continuous loss position, thus there was no recognition of any other-than-temporary impairment as of September 30, 2021 and December 31, 2020. All short-term marketable securities with unrealized losses as of each balance sheet date have been in a loss position for less than twelve months. Contractual maturities of the short-term marketable securities are within one year or less as of September 30, 2021. The long-term marketable equity securities were recorded at fair market value. The long-term marketable debt securities were considered available-for-sale at September 30, 2021. The contractual maturity of the long-term marketable debt securities are less than three years. The amortized cost, gross unrealized holding losses, and fair value of the Company’s marketable securities by major security type at each balance sheet date are summarized in the tables below (in thousands):
Contractual maturities of the marketable securities at each balance sheet date are as follows (in thousands):
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Business Combinations |
9 Months Ended |
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Sep. 30, 2021 | |
Business Combination and Asset Acquisition [Abstract] | |
Business Combinations | BUSINESS COMBINATIONS TransChart LLC In January 2021, the Company acquired TransChart for cash. TransChart provides EMR software to hospitals throughout the U.S. to care for patients who have or may need an organ transplant. As a result of the acquisition, the Company recognized goodwill of $2.2 million and intangible assets of $2.0 million. The pro forma impact of the TransChart acquisition is not material, and the results of operations of the acquisition have been included in the Company's condensed consolidated statements of operations from the respective acquisition date.
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Goodwill and Intangible Assets |
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Goodwill and Intangible Assets Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Goodwill and Intangible Assets | GOODWILL AND INTANGIBLE ASSETS Goodwill Goodwill is recorded when the purchase price of an acquisition exceeds the fair value of the net tangible and identified intangible assets acquired. Goodwill is tested annually for impairment at the reporting unit level during the fourth quarter or earlier upon the occurrence of certain events or substantive changes in circumstances. There were no indicators of impairment in the three and nine months ended September 30, 2021. The balance of the Company's goodwill as of September 30, 2021 and December 31, 2020 was $26.1 million and $23.9 million, respectively. Intangible Assets The following table presents details of the Company’s intangible assets as of September 30, 2021 ($ in thousands):
The following table presents details of the Company’s intangible assets as of December 31, 2020 ($ in thousands):
Acquisition of Intangible Assets In June 2021, the Company acquired commercialization rights in an exclusive partnership for comprehensive data analytics in relation to NGS-based metagenomics testing for infectious diseases. This is included within Commercialization rights as of September 30, 2021. In June 2021, the Company acquired the Transplant Hero patient application. The patient application is included in Acquired and developed technology as of September 30, 2021. Also in June 2021, the Company entered into a strategic agreement with OrganX to develop clinical decision support tools across the transplant patient journey. As of September 30, 2021, the Company included $2.0 million in Acquired in-process technology for milestones related to the strategic agreement. As of September 30, 2021, the Company included acquisitions of $7.5 million, which included $3.6 million of Acquired and developed technology, $2.5 million of Commercialization rights, $1.1 million of Customer relationships and $0.3 million of Other intangible assets. Amortization of Intangible Assets Amortization expense was $1.5 million and $1.2 million for the three months ended September 30, 2021 and 2020, respectively. For the three months ended September 30, 2021, expenses of $0.3 million, $0.4 million, $0.3 million and $0.5 million were amortized to cost of testing services, cost of product, cost of digital and other and sales and marketing, respectively. For the three months ended September 30, 2020, expenses of $0.3 million, $0.4 million, $0.1 million and $0.4 million were amortized to cost of testing services, cost of product, cost of digital and other and sales and marketing, respectively. Amortization expense was $4.2 million and $3.5 million for the nine months ended September 30, 2021 and 2020, respectively. For the nine months ended September 30, 2021, expenses of $1.0 million, $1.4 million, $0.5 million and $1.3 million were amortized to cost of testing, cost of product, cost of digital and other and sales and marketing, respectively. For the nine months ended September 30, 2020, expenses of $1.0 million, $1.2 million, $0.2 million and $1.1 million were amortized to cost of testing, cost of product, cost of digital and other and sales and marketing, respectively. The following table summarizes the Company’s estimated future amortization expense of intangible assets with finite lives as of September 30, 2021 (in thousands):
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Balance Sheet Components |
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Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance Sheet Components | BALANCE SHEET COMPONENTS Inventory Inventory consisted of the following (in thousands):
Accrued and Other Liabilities Accrued and other liabilities consisted of the following (in thousands):
CMS Accelerated and Advance Payment Program for Medicare Providers On March 27, 2020, the U.S. government enacted the CARES Act. Pursuant to the CARES Act, CMS expanded its Accelerated and Advance Payment Program in order to increase cash flow to providers of services and suppliers impacted by the COVID-19 pandemic. CMS was authorized to provide accelerated or advance payments during the period of the public health emergency to any Medicare provider who submitted a request to the appropriate Medicare Administrative Contractor and met the required qualifications. During April 2020, the Company received an advance payment from CMS of approximately $20.5 million and recorded the payment as Deferred revenue - CMS advance payment on the Company's condensed consolidated balance sheet. During December 2020, the Company reassessed the Deferred revenue - CMS advance payment and repaid the entire amount in January 2021. The Company recorded the amount as Refund liability - CMS advance payment on the condensed consolidated balance sheet as of December 31, 2020.
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Commitments and Contingencies |
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Commitments and Contingencies Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies | COMMITMENTS AND CONTINGENCIES Leases The Company leases its operating and office facilities for various terms under long-term, non-cancelable operating lease agreements in South San Francisco, California; Brisbane, California; West Chester, Pennsylvania; Fremantle, Australia; and Stockholm, Sweden. The Company also leases equipment under finance lease agreements. On January 2, 2020, the Company executed the second amendment to the operating lease agreement for the building located at Brisbane, California. The building is mainly utilized for laboratory operations and research and development. The lease was extended for a period of eight years and two months starting on January 1, 2021. The Company had determined that the amendment constituted a lease modification effective January 1, 2020. At the inception of the lease modification, the ROU asset increased by $13.0 million. The Company's facility leases expire at various dates through 2029. In the normal course of business, it is expected that these leases will be renewed or replaced by leases on other properties. As of September 30, 2021, the carrying value of the ROU asset was $18.3 million. The related current and non-current liabilities as of September 30, 2021 were $3.8 million and $17.9 million, respectively. The current and non-current lease liabilities are included in accrued and other current liabilities and operating lease liability, less current portion, respectively, in the condensed consolidated balance sheets. The following table summarizes the lease cost for the three and nine months ended September 30, 2021 and 2020 (in thousands):
Finance lease cost includes interest from the lease liability and amortization of the ROU asset.
Maturities of operating lease liabilities as of September 30, 2021 are as follows (in thousands):
Royalty Commitments The Board of Trustees of the Leland Stanford Junior University (“Stanford”) In June 2014, the Company entered into a license agreement with Stanford (the “Stanford License”), which granted the Company an exclusive license to a patent relating to the diagnosis of rejection in organ transplant recipients using dd-cfDNA. Under the terms of the Stanford License, the Company is required to pay an annual license maintenance fee, six milestone payments and royalties in the low single digits of net sales of products incorporating the licensed technology. Illumina On May 4, 2018, the Company entered into a license agreement with Illumina (the “Illumina Agreement”). The Illumina Agreement requires the Company to pay royalties in the mid-single to low-double digits on sales of products covered by the Illumina Agreement. Cibiltech Commitments Pursuant to that certain license and commercialization agreement that the Company entered into with Cibiltech SAS (“Cibiltech”) effective April 30, 2019, the Company will share an agreed-upon percentage of revenue with Cibiltech, if and when revenues are generated from KidneyCare iBox. Other Commitments Pursuant to the Illumina Agreement, the Company has agreed to minimum purchase commitments of finished products and raw materials from Illumina through 2023. Litigation and Indemnification Obligations In response to the Company's false advertising suit filed against Natera Inc. (“Natera”), on April 10, 2019, Natera filed a counterclaim against the Company on February 18, 2020, in the U.S. District Court for the District of Delaware (the “Court”) alleging the Company made false and misleading claims about the performance capabilities of AlloSure. The suit seeks injunctive relief and unspecified monetary relief. On September 30, 2020, Natera requested leave of Court to amend its counterclaims to include additional allegations regarding purportedly false claims the Company made with respect to AlloSure, and the Court granted Natera’s request. The trial date is not currently set. In addition, in response to the Company's patent infringement suit filed against Natera on March 26, 2019, Natera filed suit against the Company on January 13, 2020 in the Court alleging, among other things, that AlloSure infringes Natera’s U.S. Patent 10,526,658. On March 25, 2020, Natera filed an amendment to the suit alleging, among other things, that AlloSure also infringes Natera’s U.S. Patent 10,597,724. The suit seeks a judgment that the Company has infringed Natera’s patents, an order preliminarily and permanently enjoining the Company from any further infringement of such patents and unspecified damages. The Company intends to defend both of these matters vigorously, and believes that the Company has good and substantial defenses to the claims alleged in the suits, but there is no guarantee that the Company will prevail. The Company has not recorded any liabilities for these suits. United States Department of Justice and United States Securities and Exchange Commission Investigations The Company recently received a civil investigative demand (CID) from the United States Department of Justice (DOJ) requesting that the Company produce certain documents in connection with a False Claims Act investigation being conducted by the DOJ regarding certain business practices related to our kidney testing and phlebotomy services, and a subpoena from the United States Securities and Exchange Commission (SEC) in relation to an investigation by the SEC in respect of matters similar to those identified in the CID, as well as certain of our accounting and public reporting practices. The Company also received an information request from a state regulatory agency and may receive additional requests for information from the DOJ, SEC, or other regulatory and governmental agencies regarding similar or related subject matters. The Company does not believe that the CID, the SEC subpoena or the state regulatory agency information request raise any issues regarding the safety or efficacy of any of the Company's products or services and are cooperating fully with the investigations. Although the Company remains committed to compliance with all applicable laws and regulations, it cannot predict the outcome of the DOJ or SEC investigations, the state law information request, or any other requests or investigations that may arise in the future regarding these or other subject matters. From time to time, the Company may become involved in litigation and other legal actions. The Company estimates the range of liability related to any pending litigation where the amount and range of loss can be estimated. The Company records its best estimate of a loss when the loss is considered probable. Where a liability is probable and there is a range of estimated loss with no best estimate in the range, the Company records a charge equal to at least the minimum estimated liability for a loss contingency when both of the following conditions are met: (i) information available prior to issuance of the condensed consolidated financial statements indicates that it is probable that a liability had been incurred at the date of the condensed consolidated financial statements and (ii) the range of loss can be reasonably estimated.
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401(K) Plan |
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Retirement Benefits [Abstract] | |
401(K) Plan | 401(K) PLANThe Company sponsors a | defined contribution plan covering all U.S. employees under the Internal Revenue Code of 1986, as amended. Employee contributions are voluntary and are determined on an individual basis subject to the maximum allowable under federal tax regulations. The Company incurred expenses related to contributions to the plan of $0.4 million and $0.1 million for the three months ended September 30, 2021 and 2020, respectively. The Company incurred expenses related to contributions to the plan of $1.2 million and $0.6 million for the nine months ended September 30, 2021 and 2020, respectively.
Warrants |
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Warrants and Rights Note Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Warrants | WARRANTS The Company issues common stock warrants in connection with debt or equity financings to lenders, placement agents and investors. Issued warrants are considered standalone financial instruments and the terms of each warrant are analyzed for equity or liability classification in accordance with U.S. GAAP. Warrants that are classified as liabilities usually have various features that would require net-cash settlement by the Company. Warrants that are not liabilities, derivatives and/or meet the exception criteria are classified as equity. Warrants liabilities are remeasured at fair value at each period end with changes in fair value recorded in the condensed consolidated statements of operations until expired or exercised. Warrants that are classified as equity are valued at their relative fair value on the date of issuance, recorded in additional paid in capital and not remeasured. In the three months ended September 30, 2021, no warrants to purchase shares of common stock were exercised. In the nine months ended September 30, 2021, warrants to purchase approximately 3,000 shares of common stock were exercised for cash proceeds of $4 thousand. In the three months ended September 30, 2020, warrants to purchase approximately 35,000 shares of common stock were exercised for cash proceeds of less than $0.1 million. In the nine months ended September 30, 2020, warrants to purchase approximately 307,000 shares of common stock were exercised for cash proceeds of $0.3 million. During the three months ended September 30, 2020, no warrants to purchase shares of common stock were exercised on a cashless basis. During the nine months ended September 30, 2020, a warrant to purchase approximately 34,000 shares of common stock was exercised on a cashless basis and approximately 24,000 shares were issued pursuant to the exercise. As of September 30, 2021, outstanding warrants to purchase common stock were:
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Stock Incentive Plans |
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Share-based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock Incentive Plans | STOCK INCENTIVE PLANS Stock Options and Restricted Stock Units (“RSU”) The following table summarizes option and RSU activity under the Company’s 2014 Equity Incentive Plan, 2016 Inducement Equity Incentive Plan, and 2019 Inducement Equity Incentive Plan, and related information:
The total intrinsic value of options exercised was $4.2 million and $39.2 million for the three and nine months ended September 30, 2021, respectively. The total intrinsic value of options exercised was $4.0 million and $8.0 million for the three and nine months ended September 30, 2020, respectively. As of September 30, 2021, the total intrinsic value of outstanding RSUs was approximately $114.7 million and there were $74.4 million of unrecognized compensation costs related to RSUs, which are expected to be recognized over a weighted-average period of 3.09 years. Options outstanding that have vested and are expected to vest at September 30, 2021 are as follows:
The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying stock options and the fair value of the Company’s common stock at September 30, 2021 for stock options that were in-the-money. The total fair value of options that vested during the three and nine months ended September 30, 2021 was $3.6 million and $9.3 million, respectively. As of September 30, 2021, there were approximately $21.9 million of unrecognized compensation costs related to stock options, which are expected to be recognized over a weighted-average period of 2.59 years. 2014 Employee Stock Purchase Plan The Company has an Employee Stock Purchase Plan (the “ESPP”), under which employees can purchase shares of its common stock based on a percentage of their compensation, but not greater than 15% of their respective earnings; provided, however, an eligible employee’s right to purchase shares of the Company’s common stock may not accrue at a rate which exceeds $25,000 of the fair market value of such shares for each calendar year in which such rights are outstanding. The ESPP has consecutive offering periods of approximately six months in length. The purchase price per share must be equal to the lower of 85% of the fair value of the common stock on the first day of the offering period or on the exercise date. During the offering period in 2021 that ended on June 30, 2021, 21,412 shares were purchased for aggregate proceeds of $1.3 million from the issuance of shares, which occurred on July 2, 2021. During the offering period in 2020 that ended on December 31, 2020, 24,052 shares were purchased for aggregate proceeds of $0.8 million from the issuance of shares, which occurred on January 4, 2021. Valuation Assumptions The estimated fair values of employee stock options and ESPP shares were estimated using the Black-Scholes option pricing model based on the following weighted average assumptions:
Risk-free Interest Rate: The Company based the risk-free interest rate over the expected term of the award based on the constant maturity rate of U.S. Treasury securities with similar maturities as of the date of grant. Volatility: The Company used an average historical stock price volatility of its own stock and those comparable public companies that were deemed to be representative of future stock price trends. Expected Term: The expected term represents the period for which the Company’s stock-based compensation awards are expected to be outstanding and is based on analyzing the vesting and contractual terms of the awards and the holders’ historical exercise patterns and termination behavior. Expected Dividends: The Company has not paid and does not anticipate paying any dividends in the near future. Stock-Based Compensation Expense The following table summarizes stock-based compensation expense relating to employee and non-employee stock-based awards for the three and nine months ended September 30, 2021 and 2020, included in the condensed consolidated statements of operations as follows (in thousands):
No tax benefit was recognized related to stock-based compensation expense since the Company has never reported taxable income and has established a full valuation allowance to offset all of the potential tax benefits associated with its deferred tax assets. In addition, no amounts of stock-based compensation expense were capitalized for the periods presented.
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Income Taxes |
9 Months Ended |
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Sep. 30, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | INCOME TAXES The Company’s effective tax rate may vary from the U.S. federal statutory tax rate due to the change in the mix of earnings in tax jurisdictions with different statutory rates, benefits related to tax credits and the tax impact of non-deductible expenses and other permanent differences between income before income taxes and taxable income. For the three and nine months ended September 30, 2021, the Company recorded an income tax benefit of $0.2 million and $0.5 million, respectively, compared to $0.2 million and $0.9 million for the three and nine months ended September 30, 2020, respectively. The income tax benefit of $0.2 million and $0.5 million for the three and nine months ended September 30, 2021, respectively, is primarily attributable to the recognition of deferred tax assets from foreign losses. The Company assesses the realizability of its net deferred tax assets by evaluating all available evidence, both positive and negative, including (i) cumulative results of operations in recent years, (ii) sources of recent losses, (iii) estimates of future taxable income, and (iv) the length of net operating loss carryforward periods. The Company believes that based on the history of its U.S. losses and other factors, the weight of available evidence indicates that it is more likely than not that it will not be able to realize its U.S. net deferred tax assets. The Company has also placed a valuation allowance on the deferred tax assets of its Australian operations. Accordingly, the U.S. and Australia net deferred tax assets have been offset by a full valuation allowance. Starting in 2018, companies may be subject to global intangible low tax income (“GILTI”), which is a tax on foreign income in excess of a deemed return on tangible assets of foreign corporations as well as the new base erosion anti-abuse tax (“BEAT”) under the Tax Cuts and Jobs Act of 2017. GILTI will be effectively taxed at a tax rate of 10.5%. Due to the complexity of the GILTI tax rules, companies are allowed to make an accounting policy choice of either (1) treating taxes due on future U.S. inclusions in taxable income related to GILTI as a current-period expense when incurred or (2) factoring such amounts into a company’s measurement of its deferred taxes. The Company has not made an election with respect to GILTI and does not believe that GILTI will have a material impact on the Company’s 2021 taxes. The Company will continue to review the GILTI and BEAT rules to determine their applicability to the Company and the impact that the rules may have on the Company's results of operations and financial condition.
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Segment Reporting |
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Segment Reporting | SEGMENT REPORTING Operating segments are defined as components of an enterprise for which separate financial information is available that is evaluated regularly by the Company’s Chief Operating Decision Maker (“CODM”), or decision making group, whose function is to allocate resources to and assess the performance of the operating segments. The Company has identified its Chief Executive Officer as the CODM. In determining its reportable segments, the Company considered the markets and types of customers served and the products or services provided in those markets. The Company operates in a single reportable segment. Revenues by geographic regions are based upon the customers’ ship-to address for product revenue and the region of testing for testing services revenue. The following table summarizes reportable revenues by geographic regions (in thousands):
The following table summarizes long-lived assets, consisting of property and equipment, net, by geographic regions (in thousands):
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Summary of Significant Accounting Policies (Policies) |
9 Months Ended |
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Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Liquidity and Capital Resources | Liquidity and Capital Resources The Company has incurred significant losses and negative cash flows from operations since its inception and had an accumulated deficit of $367.0 million at September 30, 2021. As of September 30, 2021, the Company had cash, cash equivalents and marketable securities of $363.3 million. CMS Accelerated and Advance Payment Program for Medicare Providers On March 27, 2020 the U.S. government enacted the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”). Pursuant to the CARES Act, the Centers for Medicare & Medicaid Services (“CMS”) expanded its Accelerated and Advance Payment Program in order to increase cash flow to providers of services and suppliers impacted by the COVID-19 pandemic. CMS is authorized to provide accelerated or advance payments during the period of the public health emergency to any Medicare provider who submitted a request to the appropriate Medicare Administrative Contractor and met the required qualifications. During April 2020, the Company received an advance payment from CMS of approximately $20.5 million, and recorded the payment as Deferred revenue - CMS advance payment on the Company's condensed consolidated balance sheet. During December 2020, the Company reassessed the Deferred revenue - CMS advance payment and repaid the entire amount in January 2021. The Company recorded the amount as Refund liability - CMS advance payment on the condensed consolidated balance sheet as of December 31, 2020. Refer to Note 8, Balance Sheet Components, for further explanation. CARES Act Provider Relief Fund for Medicare Providers Pursuant to the CARES Act, the U.S. Department of Health & Human Services (“HHS”) distributed an initial tranche of $30.0 billion in funds to healthcare providers that received Medicare fee-for-service (“FFS”) reimbursements in 2019. These payments to healthcare providers are not loans and will not be required to be repaid. As a condition to receiving these payments, providers must agree to certain terms and conditions and submit sufficient documentation demonstrating that the funds are being used for healthcare-related expenses or lost revenue attributable to the COVID-19 pandemic. Due to the recent enactment of legislation and absence of definitive guidance, there is a high degree of uncertainty around the CARES Act’s implementation and the Company continues to assess the impact on its business. Furthermore, HHS has indicated that it, along with the Office of Inspector General, will be closely monitoring and auditing providers to ensure that recipients comply with the terms and conditions of relief programs and to prevent fraud and abuse. All providers will be subject to civil and criminal penalties for any deliberate omissions, misrepresentations or falsifications of any information given to HHS. Providers will be distributed a portion of the initial $30.0 billion of funds based on their share of total Medicare FFS reimbursements made by the U.S. in 2019. During April 2020, the Company received a payment of approximately $4.8 million representing its portion of the initial tranche of funds, recorded in other income (expense), net on the condensed consolidated statements of operations. The Company is complying with the key terms and provisions of the CARES Act Provider Relief Fund, which includes, among other things, the requirement that the Company maintain appropriate records and cost documentation. During the quarter ended September 30, 2021, the Company was notified by HHS that the Provider Relief Fund Reporting Portal was open for reporting on the use of Provider Relief Fund payments, and the Company completed and submitted a report indicating the use of the funds the Company received pursuant to the CARES Act.
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Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”), and follow the requirements of the Securities and Exchange Commission (the “SEC”) for interim reporting. As permitted under those rules, certain notes and other financial information that are normally required by U.S. GAAP can be condensed or omitted. These unaudited condensed consolidated financial statements have been prepared on the same basis as the Company’s annual consolidated financial statements and, in the opinion of management, reflect all adjustments, consisting only of normal recurring adjustments that are necessary for a fair statement of the Company’s financial information. The condensed consolidated balance sheet as of December 31, 2020 has been derived from audited consolidated financial statements as of that date but does not include all of the financial information required by U.S. GAAP for complete financial statements. Operating results for the three and nine months ended September 30, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021.
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Use of Estimates | Use of Estimates The preparation of unaudited condensed 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 disclosure of contingent assets and liabilities and the reported amounts of revenues and expenses in the unaudited condensed consolidated financial statements and accompanying notes. On an ongoing basis, management evaluates its estimates, including those related to transaction price estimates used for testing services revenue; standalone fair value of digital revenue performance obligations; accrued expenses for clinical studies; inventory valuation; the fair value of issued common stock warrants and embedded derivatives; the fair value of assets and liabilities acquired in a business combination or an assets acquisition (including identifiable intangible assets acquired); the fair value of contingent consideration recorded in connection with a business combination; the grant date fair value assumptions used to estimate stock-based compensation expense; income taxes; impairment of long-lived assets and indefinite-lived assets (including goodwill); and legal contingencies. Actual results could differ from those estimates.
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Concentrations of Credit Risk and Other Risks and Uncertainties | Concentrations of Credit Risk and Other Risks and Uncertainties For the three months ended September 30, 2021 and 2020, approximately 61% and 58%, respectively, of total revenue was derived from Medicare. For the nine months ended September 30, 2021 and 2020, approximately 60% and 56%, respectively, of total revenue was derived from Medicare. As of September 30, 2021 and December 31, 2020, approximately 29% and 28%, respectively, of accounts receivable was due from Medicare. No other payer or customer represented more than 10% of accounts receivable on either September 30, 2021 or December 31, 2020.
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Marketable Securities | Marketable Securities The Company considers all highly liquid investments in securities with a maturity of greater than three months at the time of purchase to be marketable securities. As of September 30, 2021, the Company’s short-term marketable securities consisted of corporate debt securities with maturities of greater than three months but less than twelve months at the time of purchase. These short-term marketable securities are classified as current assets on the condensed consolidated balance sheet. The Company classifies its short-term marketable securities as held-to-maturity at the time of purchase and reevaluates such designation at each balance sheet date. The Company has the positive intent and ability to hold these marketable securities to maturity. Short-term marketable securities are carried at amortized cost and are adjusted for amortization of premiums and accretion of discounts to maturity, which is included in interest income (expense), net on the condensed consolidated statements of operations. Realized gains and losses and declines in value judged to be other-than-temporary, if any, on short-term marketable securities are included in interest income (expense), net. The cost of securities sold will be determined using specific identification. The Company considers investments in securities with remaining maturities of over one year as long-term investments. As of September 30, 2021, the Company's long-term marketable securities consisted of corporate equity securities and corporate debt securities. These long-term marketable securities are classified as other assets on the condensed consolidated balance sheet. The Company classifies its long-term marketable debt securities as available-for-sale and reevaluates such designation at each balance sheet date. The Company records its long-term marketable equity securities at fair market value. Unrealized gains and losses from the remeasurement of the long-term marketable equity securities to fair value are included in other expense, net, in the condensed consolidated statements of operations. Realized gains and losses and declines in value judged to be other-than-temporary, if any, on long-term marketable securities are included in interest income, net.
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Leases | Leases Effective January 1, 2019, the Company adopted Accounting Standard Codification (“ASC”) Topic 842, Leases using the optional transition method and applied the standard only to leases that existed at that date. The Company determines if an arrangement is or contains a lease at contract inception. A right-of-use (“ROU”) asset, representing the underlying asset during the lease term, and a lease liability, representing the payment obligation arising from the lease, are recognized on the condensed consolidated balance sheet at lease commencement based on the present value of the payment obligation. For operating leases, expense is recognized on a straight-line basis over the lease term. For finance leases, interest expense on the lease liability is recognized using the effective interest method and amortization of the ROU asset is recognized on a straight-line basis over the shorter of the estimated useful life of the asset or the lease term. Short-term leases with an initial term of 12 months or less are not recorded on the balance sheet. The present value of lease payments is determined by using the interest rate implicit in the lease, if that rate is readily determinable; otherwise, the Company uses its incremental borrowing rate. The incremental borrowing rate is determined by using the rate of interest that the Company would pay to borrow on a collateralized basis an amount equal to the lease payments for a similar term and in a similar economic environment. As of September 30, 2021, the Company’s leases had remaining terms of 0.67 years to 7.42 years, some of which include options to extend the lease term.
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Recent Accounting Pronouncements | Recent Accounting Pronouncements In October 2020, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2020-10, Codification Improvements, which contains amendments that improve the consistency of the ASC by including all disclosure guidance in the appropriate Disclosure Section (Section 50). The FASB provided transition guidance for all the amendments in this ASU. The amendments in Sections B and C (Section A has been removed) of this ASU are effective for annual periods beginning after December 15, 2020 for public business entities. Early application of the amendments in this ASU is permitted for public business entities for any annual or interim period for which financial statements have not been issued. The amendments in this ASU should be applied retrospectively. The Company adopted the standard on January 1, 2021. The adoption of the new standard did not have an impact on the Company's condensed consolidated financial statements and disclosures. In May 2021, the FASB issued ASU No. 2021-04, Earnings Per Share (Topic 260), Debt-Modifications and Extinguishments (Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (a consensus of the FASB Emerging Issues Task Force), which contains amendments that clarify and reduce diversity in an issuer's accounting for modifications or exchanges of freestanding equity-classified written call options that remain equity classified after modification or exchange. The amendments set forth in this ASU are effective for all entities for annual periods beginning after December 15, 2021. Early application of the amendments in this ASU is permitted for all entities. The amendments in this ASU should be applied prospectively. The Company plans to adopt the standard on January 1, 2022. The Company is in the process of assessing the impact that this new standard will have on its consolidated financial statements and disclosures.
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Net Loss Per Share (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Computation of Basic and Diluted Net Loss Per Share | The following tables set forth the computation of the Company’s basic and diluted net loss per share (in thousands, except shares and per share data):
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Potentially Dilutive Securities Excluded from Diluted Net Loss Per Share | The following potentially dilutive securities have been excluded from diluted net loss per share as of September 30, 2021 and 2020 because their effect would be antidilutive:
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Fair Value Measurements (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value of Financial Assets and Liabilities Measured on Recurring Basis | The following table sets forth the Company’s financial assets and liabilities, measured at fair value on a recurring basis, as of September 30, 2021 and December 31, 2020 (in thousands):
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Summary of Issuances, Exercises, Changes in Fair Value and Reclassifications of Level 3 Financial Instruments | The following table presents the issuances, exercises, changes in fair value and reclassifications of the Company’s Level 3 financial instruments that are measured at fair value on a recurring basis (in thousands):
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Summary of Common Stock Warrant Liability Valuation Assumptions | Common Stock Warrant Liability Valuation Assumptions:
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Cash and Marketable Securities (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Cash and Cash Equivalents [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Cash and Cash Equivalents | A reconciliation of cash, cash equivalents, and restricted cash reported within the condensed consolidated balance sheets to the amount reported within the condensed consolidated statements of cash flows is shown in the table below (in thousands):
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Marketable Securities | The amortized cost, gross unrealized holding losses, and fair value of the Company’s marketable securities by major security type at each balance sheet date are summarized in the tables below (in thousands):
Contractual maturities of the marketable securities at each balance sheet date are as follows (in thousands):
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Goodwill and Intangible Assets (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Goodwill and Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Intangible Assets | The following table presents details of the Company’s intangible assets as of September 30, 2021 ($ in thousands):
The following table presents details of the Company’s intangible assets as of December 31, 2020 ($ in thousands):
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Summary of Estimated Future Amortization Expense of Intangible Assets | The following table summarizes the Company’s estimated future amortization expense of intangible assets with finite lives as of September 30, 2021 (in thousands):
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Balance Sheet Components (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Inventory | Inventory consisted of the following (in thousands):
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Components of Accrued and Other Liabilities | Accrued and other liabilities consisted of the following (in thousands):
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Commitments and Contingencies (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Lease Cost | The following table summarizes the lease cost for the three and nine months ended September 30, 2021 and 2020 (in thousands):
Finance lease cost includes interest from the lease liability and amortization of the ROU asset.
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Future Minimum Lease Commitments under Operating and Finance Leases | Maturities of operating lease liabilities as of September 30, 2021 are as follows (in thousands):
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Warrants (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Warrants and Rights Note Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Components of Warrants Outstanding | As of September 30, 2021, outstanding warrants to purchase common stock were:
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Stock Incentive Plans (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Option, Unvested RSU Activity under 2014 Equity Incentive Plan and 2016 Inducement Equity Incentive Plan and Related Information | The following table summarizes option and RSU activity under the Company’s 2014 Equity Incentive Plan, 2016 Inducement Equity Incentive Plan, and 2019 Inducement Equity Incentive Plan, and related information:
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Summary of Options Outstanding and Exercisable Vested or Expected to Vest | Options outstanding that have vested and are expected to vest at September 30, 2021 are as follows:
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Weighted-Average Assumptions Used to Estimate Fair Values of Share-Based Awards | The estimated fair values of employee stock options and ESPP shares were estimated using the Black-Scholes option pricing model based on the following weighted average assumptions:
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Summary of Expense Relating to Employee and Nonemployee Stock-Based Payment Awards from Stock Options and RSUs | The following table summarizes stock-based compensation expense relating to employee and non-employee stock-based awards for the three and nine months ended September 30, 2021 and 2020, included in the condensed consolidated statements of operations as follows (in thousands):
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Segment Reporting (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Segment Reporting [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reportable Revenues by Geographic Regions | Revenues by geographic regions are based upon the customers’ ship-to address for product revenue and the region of testing for testing services revenue. The following table summarizes reportable revenues by geographic regions (in thousands):
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Long-Lived Assets Consisting of Property and Equipment, Net by Geographic Regions | The following table summarizes long-lived assets, consisting of property and equipment, net, by geographic regions (in thousands):
|
Summary of Significant Accounting Policies - Concentration of Credit Risk (Detail) - Medicare |
3 Months Ended | 9 Months Ended | 12 Months Ended | ||
---|---|---|---|---|---|
Sep. 30, 2021 |
Sep. 30, 2020 |
Sep. 30, 2021 |
Sep. 30, 2020 |
Dec. 31, 2020 |
|
Revenues | Customer Concentration Risk | |||||
Concentration Risk [Line Items] | |||||
Concentration risk percentage | 61.00% | 58.00% | 60.00% | 56.00% | |
Accounts Receivable | Credit Concentration Risk | |||||
Concentration Risk [Line Items] | |||||
Concentration risk percentage | 29.00% | 28.00% |
Summary of Significant Accounting Policies - Leases (Detail) |
9 Months Ended |
---|---|
Sep. 30, 2021 | |
Minimum | |
Summary Of Significant Accounting Policies [Line Items] | |
Remaining lease terms | 8 months 1 day |
Maximum | |
Summary Of Significant Accounting Policies [Line Items] | |
Remaining lease terms | 7 years 5 months 1 day |
Net Loss Per Share - Computation of Basic and Diluted Net Loss Per Share (Detail) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | 9 Months Ended | ||||||
---|---|---|---|---|---|---|---|---|
Sep. 30, 2021 |
Jun. 30, 2021 |
Mar. 31, 2021 |
Sep. 30, 2020 |
Jun. 30, 2020 |
Mar. 31, 2020 |
Sep. 30, 2021 |
Sep. 30, 2020 |
|
Numerator: | ||||||||
Net loss used to compute basic and diluted net loss per share | $ (11,897) | $ (1,927) | $ (687) | $ (2,818) | $ (6,558) | $ (5,823) | $ (14,511) | $ (15,199) |
Denominator: | ||||||||
Weighted-average shares used to compute basic net loss per share (in shares) | 52,681,451 | 49,010,680 | 52,034,450 | 45,526,810 | ||||
Weighted-average shares used to compute diluted net loss per share (in shares) | 52,681,451 | 49,010,680 | 52,034,450 | 45,526,810 | ||||
Net loss per share: | ||||||||
Basic (in dollars per share) | $ (0.23) | $ (0.06) | $ (0.28) | $ (0.33) | ||||
Diluted (in dollars per share) | $ (0.23) | $ (0.06) | $ (0.28) | $ (0.33) |
Fair Value Measurements - Summary of Issuances, Exercises, Changes in Fair Value and Reclassifications of Level 3 Financial Instruments (Detail) - Common Stock Warrants Liability - (Level 3) - Common Stock Warrant Liability $ in Thousands |
9 Months Ended |
---|---|
Sep. 30, 2021
USD ($)
| |
Fair Value, Assets Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Beginning balance | $ 447 |
Exercise of warrants | (202) |
Change in estimated fair value | (50) |
Ending balance | $ 195 |
Fair Value Measurements - Summary of Common Stock Warrant Liability Valuation Assumptions (Detail) - Private Placement Common Stock Warrant Liability |
9 Months Ended | 12 Months Ended |
---|---|---|
Sep. 30, 2021
$ / shares
|
Dec. 31, 2020
$ / shares
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Stock price (in dollars per share) | $ 63.37 | $ 72.45 |
Exercise Price | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Exercise price (in dollars per share) | $ 1.12 | $ 1.12 |
Remaining term (in years) | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Remaining term (in years) | 1 year 6 months 14 days | 2 years 3 months 10 days |
Volatility | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability measurement input | 0.6600 | 0.7300 |
Risk-free interest rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability measurement input | 0.0019 | 0.0014 |
Cash and Marketable Securities - Reconciliation of Cash and Cash Equivalents (Details) - USD ($) $ in Thousands |
Sep. 30, 2021 |
Dec. 31, 2020 |
Sep. 30, 2020 |
Dec. 31, 2019 |
---|---|---|---|---|
Cash and Cash Equivalents [Abstract] | ||||
Cash and cash equivalents | $ 353,082 | $ 134,669 | $ 213,798 | $ 38,223 |
Restricted cash | 210 | 270 | 260 | 256 |
Total cash, cash equivalents, and restricted cash at the end of the period | $ 353,292 | $ 134,939 | $ 214,058 | $ 38,479 |
Cash and Marketable Securities - Components of Marketable Securities (Details) - USD ($) $ in Thousands |
Sep. 30, 2021 |
May 31, 2021 |
Dec. 31, 2020 |
---|---|---|---|
Short-term marketable securities | |||
Amortized Cost | $ 10,199 | $ 90,034 | |
Unrealized Holding Gains (Losses) | (2) | (136) | |
Fair Value | 10,197 | 89,898 | |
Long-term marketable securities | |||
Amortized Cost | 5,500 | ||
Unrealized Holding Gains (Losses) | (167) | ||
Fair Value | 5,333 | ||
Amortized Cost | 15,699 | ||
Unrealized Holding Gains (Losses) | (169) | ||
Fair Value | 15,530 | ||
Corporate debt securities | |||
Short-term marketable securities | |||
Amortized Cost | 10,199 | 90,034 | |
Unrealized Holding Gains (Losses) | (2) | (136) | |
Fair Value | 10,197 | $ 89,898 | |
Long-term marketable securities | |||
Debt securities, amortized cost | 500 | ||
Debt securities, unrealized holding gains (losses) | 0 | ||
Fair value | 500 | ||
Corporate equity securities | |||
Long-term marketable securities | |||
Equity securities, amortized cost | 5,000 | $ 5,000 | |
Equity securities, unrealized holding gains (losses) | (167) | ||
Corporate equity securities | $ 4,833 |
Cash and Marketable Securities - Schedule of Maturity (Details) - USD ($) $ in Thousands |
Sep. 30, 2021 |
Dec. 31, 2020 |
---|---|---|
Cash and Cash Equivalents [Abstract] | ||
Within one year | $ 10,199 | $ 90,034 |
After one year through five years | 500 | 0 |
Amortized Cost | $ 10,699 | $ 90,034 |
Business Combinations - Additional Information (Detail) - USD ($) $ in Thousands |
Sep. 30, 2021 |
Jan. 31, 2021 |
Dec. 31, 2020 |
---|---|---|---|
Business Acquisition [Line Items] | |||
Goodwill | $ 26,051 | $ 23,857 | |
TransChart LLC | |||
Business Acquisition [Line Items] | |||
Goodwill | $ 2,200 | ||
Intangible assets | $ 2,000 |
Balance Sheet Components - Summary of Inventory (Detail) - USD ($) $ in Thousands |
Sep. 30, 2021 |
Dec. 31, 2020 |
---|---|---|
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Finished goods | $ 2,871 | $ 1,702 |
Work in progress | 2,806 | 2,936 |
Raw materials | 13,123 | 5,374 |
Total inventory | $ 18,800 | $ 10,012 |
Balance Sheet Components - Components of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands |
Sep. 30, 2021 |
Dec. 31, 2020 |
---|---|---|
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Clinical studies | $ 9,632 | $ 6,733 |
Short-term lease liability | 3,822 | 2,033 |
Deferred revenue | 3,409 | 3,530 |
Professional fees | 2,980 | 1,529 |
Deferred payments for intangible assets | 2,000 | 2,000 |
Capital expenditures | 1,648 | 0 |
Accrued royalty | 1,598 | 1,072 |
Test sample processing fees | 1,295 | 416 |
Contingent consideration | 642 | 738 |
Other accrued expenses | 3,573 | 2,551 |
Total accrued and other liabilities | $ 30,599 | $ 20,602 |
Balance Sheet Components - Additional Information (Details) $ in Millions |
1 Months Ended |
---|---|
Apr. 30, 2020
USD ($)
| |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Accelerated and advanced payment | $ 20.5 |
Commitments and Contingencies - Additional Information (Detail) $ in Thousands |
1 Months Ended | ||||
---|---|---|---|---|---|
Jun. 30, 2014
milestone_payment
|
Sep. 30, 2021
USD ($)
|
Jan. 01, 2021 |
Dec. 31, 2020
USD ($)
|
Jan. 01, 2020
USD ($)
|
|
Commitments and Contingencies Disclosure [Abstract] | |||||
Lease extension term period | 8 years 2 months | ||||
Operating lease, right-of-use asset increase amount | $ 13,000 | ||||
Operating leases right-of-use assets | $ 18,316 | $ 15,228 | |||
Less operating lease liability, current portion | 3,822 | 2,033 | |||
Operating lease liability, less current portion | $ 17,876 | $ 16,069 | |||
Number of milestone payments | milestone_payment | 6 |
Commitments and Contingencies - Summary of Lease Cost (Detail) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2021 |
Sep. 30, 2020 |
Sep. 30, 2021 |
Sep. 30, 2020 |
|
Commitments and Contingencies Disclosure [Abstract] | ||||
Operating lease cost | $ 1,345 | $ 1,120 | $ 3,757 | $ 3,353 |
Finance lease cost | 0 | 51 | 53 | 155 |
Total lease cost | $ 1,345 | $ 1,171 | $ 3,810 | $ 3,508 |
Commitments and Contingencies - Summary of Other Information Related to Lease (Detail) |
Sep. 30, 2021 |
---|---|
Other information: | |
Weighted-average remaining lease term - Operating leases (in years) | 6 years 2 months 4 days |
Weighted-average remaining lease term - Finance leases (in years) | 0 years |
Weighted-average discount rate - Operating leases | 10.10% |
Weighted-average discount rate - Finance leases | 0.00% |
Commitments and Contingencies - Future Minimum Lease Commitments under Operating and Finance Leases (Detail) - USD ($) $ in Thousands |
Sep. 30, 2021 |
Dec. 31, 2020 |
---|---|---|
Operating Leases | ||
Remainder of 2021 | $ 1,387 | |
2022 | 5,539 | |
2023 | 4,209 | |
2024 | 4,216 | |
2025 | 3,980 | |
Thereafter | 10,256 | |
Total lease payments | 29,587 | |
Less imputed interest | 7,889 | |
Present value of future minimum lease payments | 21,698 | |
Less operating lease liability, current portion | 3,822 | $ 2,033 |
Operating lease liability, long-term portion | $ 17,876 | $ 16,069 |
401(K) Plan - Additional Information (Detail) - USD ($) $ in Millions |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2021 |
Sep. 30, 2020 |
Sep. 30, 2021 |
Sep. 30, 2020 |
|
Retirement Benefits [Abstract] | ||||
401(k) | Postemployment Retirement Benefits [Member] | |||
Expense incurred related to plan | $ 0.4 | $ 0.1 | $ 1.2 | $ 0.6 |
Warrants - Additional Information (Detail) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | |
---|---|---|---|
Sep. 30, 2020 |
Sep. 30, 2021 |
Sep. 30, 2020 |
|
Warrants and Rights Note Disclosure [Abstract] | |||
Number of warrants exercised | 0 | ||
Purchase of common stock warrants exercised (in shares) | 35,000 | 3,000 | 307,000 |
Number of warrants exercised on cashless basis (in shares) | 0 | 34,000,000 | |
Proceeds from warrant exercises | $ 100 | $ 4 | $ 343 |
Shares issued (in shares) | 24,000,000 |
Warrants - Outstanding Warrants To Purchase Common Stock Warrants (Detail) - Common Stock |
9 Months Ended |
---|---|
Sep. 30, 2021
$ / shares
shares
| |
Class of Warrant or Right [Line Items] | |
Number of shares underlying warrants (in shares) | 3,132 |
Original issue date of April 2016 | |
Class of Warrant or Right [Line Items] | |
Exercise price (in dollars per share) | $ / shares | $ 1.12 |
Number of shares underlying warrants (in shares) | 3,132 |
Original issue date of April 2016 | Original Term | |
Class of Warrant or Right [Line Items] | |
Original Term | 7 years |
Stock Incentive Plans - Summary of Options Outstanding Vested and Expected to Vest (Detail) $ / shares in Units, shares in Thousands, $ in Thousands |
9 Months Ended |
---|---|
Sep. 30, 2021
USD ($)
$ / shares
shares
| |
Share-based Payment Arrangement [Abstract] | |
Number of vested shares (in shares) | shares | 930 |
Number of shares expected to vest (in shares) | shares | 954 |
Number of shares total (in shares) | shares | 1,884 |
Weighted-average exercise price vested (in dollars per share) | $ / shares | $ 19.07 |
Weighted-average exercise price expected to vest (in dollars per share) | $ / shares | $ 36.87 |
Weighted-average remaining contractual life vested (in years) | 6 years 8 months 8 days |
Weighted-average remaining contractual life expected to vest (in years) | 8 years 4 months 2 days |
Aggregate intrinsic value vested | $ | $ 41,278 |
Aggregate intrinsic value expected to vest | $ | 28,184 |
Aggregate intrinsic value total | $ | $ 69,462 |
Stock Incentive Plans - Weighted-Average Assumptions Used to Estimated Fair Values of Share-Based Awards (Detail) |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2021 |
Sep. 30, 2020 |
Sep. 30, 2021 |
Sep. 30, 2020 |
|
Employee stock purchase plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term (in years) | 6 months | 6 months | 6 months | 6 months |
Expected volatility | 68.73% | 93.17% | 58.31% | 75.36% |
Risk-free interest rate | 0.05% | 0.17% | 0.08% | 0.98% |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Employee stock options | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Expected term (in years) | 6 years | 6 years | 5 years 10 months 24 days | 6 years |
Expected volatility | 78.27% | 77.24% | 77.84% | 76.12% |
Risk-free interest rate | 0.85% | 0.36% | 0.77% | 0.69% |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2021 |
Sep. 30, 2020 |
Sep. 30, 2021 |
Sep. 30, 2020 |
|
Income Tax Disclosure [Abstract] | ||||
Income tax benefit | $ 162 | $ 235 | $ 525 | $ 865 |
Segment Reporting - Long-Lived Assets Consisting of Property and Equipment, Net by Geographic Regions (Detail) - USD ($) $ in Thousands |
Sep. 30, 2021 |
Dec. 31, 2020 |
---|---|---|
Segment Reporting Information [Line Items] | ||
Long-lived assets | $ 18,719 | $ 10,704 |
United States | ||
Segment Reporting Information [Line Items] | ||
Long-lived assets | 17,925 | 9,888 |
Europe | ||
Segment Reporting Information [Line Items] | ||
Long-lived assets | 525 | 351 |
Rest of World | ||
Segment Reporting Information [Line Items] | ||
Long-lived assets | $ 269 | $ 465 |
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