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 June 30, 2022 and December 31, 2021 | |||||
Condensed Consolidated Statements of Operations for the Three and Six Months Ended June 30, 2022 and 2021 | |||||
Condensed Consolidated Statements of Comprehensive Loss for the Three and Six Months Ended June 30, 2022 and 2021 | |||||
Condensed Consolidated Statements of Stockholders’ Equity for the Three and Six Months Ended June 30, 2022 and 2021 | |||||
Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2022 and 2021 | |||||
June 30, 2022 | December 31, 2021 | ||||||||||
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 | |||||||||||
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 June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
Revenue: | |||||||||||||||||||||||
Testing services revenue | $ | $ | $ | $ | |||||||||||||||||||
Product revenue | |||||||||||||||||||||||
Patient and digital solutions revenue | |||||||||||||||||||||||
Total revenue | |||||||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||
Cost of testing services | |||||||||||||||||||||||
Cost of product | |||||||||||||||||||||||
Cost of patient and digital solutions | |||||||||||||||||||||||
Research and development | |||||||||||||||||||||||
Sales and marketing | |||||||||||||||||||||||
General and administrative | |||||||||||||||||||||||
Total operating expenses | |||||||||||||||||||||||
Loss from operations | ( | ( | ( | ( | |||||||||||||||||||
Other (expense) income: | |||||||||||||||||||||||
Interest income, net | |||||||||||||||||||||||
Change in estimated fair value of common stock warrant liability | ( | ( | |||||||||||||||||||||
Other (expense) income, 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 June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
Net loss | $ | ( | $ | ( | $ | ( | $ | ( | |||||||||||||||
Other comprehensive 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, 2021 | $ | $ | $ | ( | $ | ( | $ | ||||||||||||||||||||||||||||
Issuance of common stock under employee stock purchase plan | — | — | — | ||||||||||||||||||||||||||||||||
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, 2022 | ( | ( | |||||||||||||||||||||||||||||||||
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, 2022 | $ | $ | $ | ( | $ | ( | $ | ||||||||||||||||||||||||||||
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 employee stock purchase plan | — | — | — | ||||||||||||||||||||||||||||||||
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 upon cash exercise of warrants | — | — | — | ||||||||||||||||||||||||||||||||
Employee stock-based compensation expense | — | — | — | — | |||||||||||||||||||||||||||||||
Foreign currency translation adjustment | — | — | — | — | |||||||||||||||||||||||||||||||
Net loss | — | — | — | — | ( | ( | |||||||||||||||||||||||||||||
Balance at June 30, 2021 | $ | $ | $ | ( | $ | ( | $ | ||||||||||||||||||||||||||||
Six Months Ended June 30, | |||||||||||
2022 | 2021 | ||||||||||
Operating activities: | |||||||||||
Net loss | $ | ( | $ | ( | |||||||
Adjustments to reconcile net loss to net cash 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 (gain) 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 operating activities | ( | ( | |||||||||
Investing activities: | |||||||||||
Acquisition of business, net of cash acquired | ( | ( | |||||||||
Acquisition of intangible assets | ( | ( | |||||||||
Purchases of short-term marketable securities | ( | ( | |||||||||
Maturities of short-term marketable securities | |||||||||||
Additions of capital expenditures, net | ( | ( | |||||||||
Net cash (used in) provided by investing activities | ( | ||||||||||
Financing activities: | |||||||||||
Proceeds from issuance of common shares in public 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 | ( | ||||||||||
Payment of contingent consideration | ( | ||||||||||
Net cash (used in) provided by financing activities | ( | ||||||||||
Effect of exchange rate changes on cash, cash equivalents and restricted cash | ( | ||||||||||
Net (decrease) 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 June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
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 Six Months Ended | |||||||||||
2022 | 2021 | ||||||||||
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 |
June 30, 2022 | |||||||||||||||||||||||
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 | |||||||||||||||||||||||
Short-term liabilities: | |||||||||||||||||||||||
Contingent consideration | $ | $ | $ | $ | |||||||||||||||||||
Long-term liabilities: | |||||||||||||||||||||||
Contingent consideration | |||||||||||||||||||||||
Common stock warrant liability | |||||||||||||||||||||||
Total | $ | $ | $ | $ |
December 31, 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 | |||||||||||||||||||||||
Short-term liabilities: | |||||||||||||||||||||||
Contingent consideration | $ | $ | $ | $ | |||||||||||||||||||
Long-term liabilities: | |||||||||||||||||||||||
Contingent consideration | |||||||||||||||||||||||
Common stock warrant liability | |||||||||||||||||||||||
Total | $ | $ | $ | $ |
(Level 3) | |||||
Common Stock Warrant Liability and Contingent Consideration | |||||
Balance as of December 31, 2021 | $ | ||||
Change in estimated fair value of common stock warrant liability | ( | ||||
Change in estimated fair value of contingent consideration | |||||
Payments related to contingent consideration | ( | ||||
Balance as of June 30, 2022 | $ |
June 30, 2022 | December 31, 2021 | ||||||||||
Private Placement Common Stock Warrant Liability | |||||||||||
Stock Price | $ | $ | |||||||||
Exercise Price | $ | $ | |||||||||
Remaining term (in years) | |||||||||||
Volatility | N/A | % | |||||||||
Risk-free interest rate | N/A | % |
June 30, 2022 | June 30, 2021 | ||||||||||
Cash and cash equivalents | $ | $ | |||||||||
Restricted cash | |||||||||||
Total cash, cash equivalents, and restricted cash at the end of the period | $ | $ |
June 30, 2022 | |||||||||||||||||
Amortized Cost | Unrealized Holding 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, 2021 | |||||||||||||||||
Amortized Cost | Unrealized Holding Losses | Fair Value | |||||||||||||||
Long-term marketable securities: | |||||||||||||||||
Corporate equity securities | $ | $ | ( | $ | |||||||||||||
Corporate debt securities | |||||||||||||||||
Total long-term marketable securities | $ | $ | ( | $ |
June 30, 2022 | December 31, 2021 | ||||||||||
Within one year | $ | $ | |||||||||
After one year through five years | |||||||||||
Total | $ | $ | |||||||||
Estimated Fair Value | Estimated Useful Life (Years) | ||||||||||
Trademark | $ |
Estimated Fair Value | Estimated Useful Lives (Years) | ||||||||||
Customer relationships | $ | ||||||||||
Developed technology | |||||||||||
Trademarks | |||||||||||
Total | $ |
Total | |||||
Consideration | |||||
Cash | $ | ||||
Total consideration | $ | ||||
Recognized amounts of identifiable assets acquired and liabilities assumed | |||||
Current assets | $ | ||||
Fixed assets | |||||
Identifiable intangible assets | |||||
Other assets | |||||
Current liabilities | ( | ||||
Noncurrent liabilities | ( | ||||
Total identifiable net assets acquired | |||||
Goodwill | |||||
Total consideration | $ |
June 30, 2022 | |||||||||||||||||||||||||||||
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 | $ | $ | ( | $ | ( | $ |
December 31, 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 | $ | $ | ( | $ | ( | $ |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
Cost of testing services | $ | $ | $ | $ | |||||||||||||||||||
Cost of product | |||||||||||||||||||||||
Cost of patient and digital solutions | |||||||||||||||||||||||
Sales & marketing | |||||||||||||||||||||||
Total | $ | $ | $ | $ |
Years Ending December 31, | Cost of Testing Services | Cost of Product | Cost of Patient and Digital Solutions | Sales and Marketing | Total | |||||||||||||||||||||||||||
Remainder of 2022 | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||
2023 | ||||||||||||||||||||||||||||||||
2024 | ||||||||||||||||||||||||||||||||
2025 | ||||||||||||||||||||||||||||||||
2026 | ||||||||||||||||||||||||||||||||
Thereafter | ||||||||||||||||||||||||||||||||
Total future amortization expense | $ | $ | $ | $ | $ |
June 30, 2022 | December 31, 2021 | ||||||||||
Finished goods | $ | $ | |||||||||
Work in progress | |||||||||||
Raw materials | |||||||||||
Total inventory | $ | $ |
June 30, 2022 | December 31, 2021 | ||||||||||
Clinical studies | $ | $ | |||||||||
Professional fees | |||||||||||
Deferred revenue | |||||||||||
Short-term lease liability | |||||||||||
Deferred payments for intangible assets | |||||||||||
Contingent consideration | |||||||||||
Capital expenditures | |||||||||||
Laboratory processing fees & materials | |||||||||||
Accrued royalty | |||||||||||
Accrued shipping expenses | |||||||||||
Other accrued expenses | |||||||||||
Total accrued and other liabilities | $ | $ |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
Operating lease cost | $ | $ | $ | $ | |||||||||||||||||||
Finance lease cost | |||||||||||||||||||||||
Total lease cost | $ | $ | $ | $ |
June 30, 2022 | |||||
Other information: | |||||
Weighted-average remaining lease term - Operating leases (in years) | |||||
Weighted-average discount rate - Operating leases (%) | % | ||||
Years Ending December 31, | Operating Leases | ||||
Remainder of 2022 | $ | ||||
2023 | |||||
2024 | |||||
2025 | |||||
2026 | |||||
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, 2021 | $ | $ | |||||||||||||||||||||||||||
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—June 30, 2022 | $ | $ |
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 June 30, | Six Months Ended June 30, | |||||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||
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 June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
Cost of testing services | $ | $ | $ | $ | |||||||||||||||||||
Cost of product | |||||||||||||||||||||||
Cost of patient and digital solutions | |||||||||||||||||||||||
Research and development | |||||||||||||||||||||||
Sales and marketing | |||||||||||||||||||||||
General and administrative | |||||||||||||||||||||||
Total | $ | $ | $ | $ |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
Testing services revenue | |||||||||||||||||||||||
United States | $ | $ | $ | $ | |||||||||||||||||||
Rest of World | |||||||||||||||||||||||
$ | $ | $ | $ | ||||||||||||||||||||
Product revenue | |||||||||||||||||||||||
United States | $ | $ | $ | $ | |||||||||||||||||||
Europe | |||||||||||||||||||||||
Rest of World | |||||||||||||||||||||||
$ | $ | $ | $ | ||||||||||||||||||||
Patient and digital solutions revenue | |||||||||||||||||||||||
United States | $ | $ | $ | $ | |||||||||||||||||||
Europe | |||||||||||||||||||||||
Rest of World | |||||||||||||||||||||||
$ | $ | $ | $ | ||||||||||||||||||||
Total United States | $ | $ | $ | $ | |||||||||||||||||||
Total Europe | $ | $ | $ | $ | |||||||||||||||||||
Total Rest of World | $ | $ | $ | $ | |||||||||||||||||||
Total | $ | $ | $ | $ |
June 30, 2022 | December 31, 2021 | ||||||||||
Long-lived assets: | |||||||||||
United States | $ | $ | |||||||||
Europe | |||||||||||
Rest of World | |||||||||||
Total | $ | $ |
Three Months Ended June 30, | |||||||||||||||||
2022 | 2021 | Change | |||||||||||||||
Revenue: | |||||||||||||||||
Testing services revenue | $ | 67,135 | $ | 64,890 | $ | 2,245 | |||||||||||
Product revenue | 6,714 | 6,861 | (147) | ||||||||||||||
Patient and digital solutions revenue | 6,785 | 2,437 | 4,348 | ||||||||||||||
Total revenue | 80,634 | 74,188 | 6,446 | ||||||||||||||
Operating expenses: | |||||||||||||||||
Cost of testing services | 18,230 | 17,235 | 995 | ||||||||||||||
Cost of product | 3,887 | 5,205 | (1,318) | ||||||||||||||
Cost of patient and digital solutions | 5,422 | 1,533 | 3,889 | ||||||||||||||
Research and development | 22,632 | 19,036 | 3,596 | ||||||||||||||
Sales and marketing | 26,950 | 19,599 | 7,351 | ||||||||||||||
General and administrative | 25,232 | 16,322 | 8,910 | ||||||||||||||
Total operating expenses | 102,353 | 78,930 | 23,423 | ||||||||||||||
Loss from operations | (21,719) | (4,742) | (16,977) | ||||||||||||||
Other (expense) income: | |||||||||||||||||
Interest income, net | 478 | 1 | 477 | ||||||||||||||
Change in estimated fair value of common stock warrant liability | 48 | (65) | 113 | ||||||||||||||
Other (expense) income, net | (553) | 2,779 | (3,332) | ||||||||||||||
Total other (expense) income | (27) | 2,715 | (2,742) | ||||||||||||||
Loss before income taxes | (21,746) | (2,027) | (19,719) | ||||||||||||||
Income tax benefit | 49 | 100 | (51) | ||||||||||||||
Net loss | $ | (21,697) | $ | (1,927) | $ | (19,770) |
Six Months Ended June 30, | |||||||||||||||||
2022 | 2021 | Change | |||||||||||||||
Revenue: | |||||||||||||||||
Testing services revenue | $ | 133,579 | $ | 124,171 | $ | 9,408 | |||||||||||
Product revenue | 13,502 | 12,639 | 863 | ||||||||||||||
Patient and digital solutions revenue | 12,969 | 4,778 | 8,191 | ||||||||||||||
Total revenue | 160,050 | 141,588 | 18,462 | ||||||||||||||
Operating expenses: | |||||||||||||||||
Cost of testing services | 35,858 | 33,718 | 2,140 | ||||||||||||||
Cost of product | 8,286 | 8,852 | (566) | ||||||||||||||
Cost of patient and digital solutions | 10,277 | 2,982 | 7,295 | ||||||||||||||
Research and development | 44,512 | 35,040 | 9,472 | ||||||||||||||
Sales and marketing | 50,098 | 35,051 | 15,047 | ||||||||||||||
General and administrative | 51,791 | 31,545 | 20,246 | ||||||||||||||
Total operating expenses | 200,822 | 147,188 | 53,634 | ||||||||||||||
Loss from operations | (40,772) | (5,600) | (35,172) | ||||||||||||||
Other (expense) income: | |||||||||||||||||
Interest income, net | 667 | 127 | 540 | ||||||||||||||
Change in estimated fair value of common stock warrant liability | 75 | (38) | 113 | ||||||||||||||
Other (expense) income, net | (1,376) | 2,534 | (3,910) | ||||||||||||||
Total other (expense) income | (634) | 2,623 | (3,257) | ||||||||||||||
Loss before income taxes | (41,406) | (2,977) | (38,429) | ||||||||||||||
Income tax benefit | 61 | 363 | (302) | ||||||||||||||
Net loss | $ | (41,345) | $ | (2,614) | $ | (38,731) |
Six Months Ended June 30, | |||||||||||
2022 | 2021 | ||||||||||
(in thousands) | |||||||||||
Net cash (used in) provided by: | |||||||||||
Operating activities | $ | (25,345) | $ | (23,842) | |||||||
Investing activities | (155,242) | 35,292 | |||||||||
Financing activities | (1,132) | 189,609 | |||||||||
Effect of exchange rate changes on cash, cash equivalents and restricted cash | 59 | (105) | |||||||||
Net (decrease) increase in cash, cash equivalents and restricted cash | $ | (181,660) | $ | 200,954 |
(a) Total Number of Shares (or Units) Purchased | (b) Average Price Paid per Share (or Unit) | ||||||||||
April 1, 2022 - April 30, 2022 | 67,279 | (1) | $ | 14.43 | |||||||
May 1, 2022 - May 31, 2022 | 6,576 | (1) | 8.39 | ||||||||
June 1, 2022 - June 30, 2022 | 17,304 | (1) | 4.15 | ||||||||
Total | 91,159 | — |
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*† | ||||||||
10.2#* | ||||||||
10.3#* | ||||||||
10.4+* | ||||||||
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. |
# | Indicates management contract or compensatory plan or arrangement. | |||||||
* | Filed herewith. | |||||||
** | Furnished herewith. | |||||||
† | Certain identified information has been omitted pursuant to Item 601(b)(10) of Regulation S-K because such information is both (i) not material and (ii) information that the Registrant treats as private or confidential. The Registrant hereby undertakes to furnish supplemental copies of the unredacted exhibit upon request by the SEC. | |||||||
+ | Non-material schedules and exhibits have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Registrant hereby undertakes to furnish supplementally copies of any of the omitted schedules and exhibits upon request by the SEC. |
CAREDX, INC. | ||||||||
(Registrant) | ||||||||
Date: August 4, 2022 | By: | /s/ REGINALD SEETO, MBBS | ||||||
Reginald Seeto, MBBS | ||||||||
President and Chief Executive Officer | ||||||||
(Principal Executive Officer) | ||||||||
By: | /s/ ABHISHEK JAIN | |||||||
Abhishek Jain | ||||||||
Interim Chief Financial Officer | ||||||||
(Principal Accounting and Financial Officer) |
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(a)Initiation of any clinical trial | $[***] | ||||
(a)First commercial sale | $[***] | ||||
(a)FDA or ex-US equiv. approval | $[***] | ||||
(a)Sales > $[***] | $[***] | ||||
(a)Patent Issuance | $[***] | ||||
(a)Net Sales of Licensed Product exceeds $[***] | $[***] |
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Report Covering Period | |||||
Yearly Maintenance Fee | $ | ||||
Number of Sublicenses Executed | |||||
Gross Revenue | $ | ||||
Net Sales | $ | ||||
Royalty Calculation | |||||
Royalty Subtotal | $ | ||||
Credit | $ | ||||
Royalty Due | $ |
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Country | Title | Serial Number | File Date | Publication Number | ||||||||||
Australia | NON-INVASIVE DIAGNOSIS OF GRAFT REJECTION IN ORGAN TRANSPLANT PATIENTS | 2010315084 | 05-Nov-2010 | 2010315084 | ||||||||||
Canada | NON-INVASIVE DIAGNOSIS OF GRAFT REJECTION IN ORGAN TRANSPLANT PATIENTS | 2,779,750 | 05-Nov-2010 | 2779750 | ||||||||||
China (People’s Republic) | NON-INVASIVE DIAGNOSIS OF GRAFT REJECTION IN ORGAN TRANSPLANT PATIENTS | 201080060469.4 | 05-Nov-2010 | 102712954 | ||||||||||
European Patent Convention | NON-INVASIVE DIAGNOSIS OF GRAFT REJECTION IN ORGAN TRANSPLANT PATIENTS | 10829142.8 | 05-Nov-2010 | 2496720 | ||||||||||
Hong Kong | NON-INVASIVE DIAGNOSIS OF GRAFT REJECTION IN ORGAN TRANSPLANT PATIENTS | 13102099.1 | 05-Nov-2010 | 1175268 | ||||||||||
Japan | NON-INVASIVE DIAGNOSIS OF GRAFT REJECTION IN ORGAN TRANSPLANT PATIENTS | 2012-538027 | 05-Nov-2010 | 2013509883 | ||||||||||
Patent Cooperation Treaty | NON-INVASIVE DIAGNOSIS OF GRAFT REJECTION IN ORGAN TRANSPLANT PATIENTS | US2010/055604 | 05-Nov-2010 | 2011057061 | ||||||||||
United Kingdom | NON-INVASIVE DIAGNOSIS OF GRAFT REJECTION IN ORGAN TRANSPLANT PATIENTS | 1209978.4 | 05-Nov-2010 | 2488289 | ||||||||||
United States of America | NON-INVASIVE DIAGNOSIS OF GRAFT REJECTION IN ORGAN TRANSPLANT PATIENTS | 61/280,674 | 06-Nov-2009 | N/A | ||||||||||
United States of America | NON-INVASIVE DIAGNOSIS OF GRAFT REJECTION IN ORGAN TRANSPLANT PATIENTS | 13/508,318 | 19-Jul-2012 | 20120295810 |
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LEGAL_US_W # 112905540.1 |
LEGAL_US_W # 112905540.1 |
LEGAL_US_W # 112905540.1 |
LEGAL_US_W # 112905540.1 |
LEGAL_US_W # 112905540.1 |
LEGAL_US_W # 112905540.1 |
LEGAL_US_W # 112905540.1 |
LEGAL_US_W # 112905675.1 |
TERMS OF LEASE | DESCRIPTION | ||||||||||||||||
Date: | June 14, 2022. | ||||||||||||||||
Premises (Article 1). | |||||||||||||||||
2.1.Building: | That certain 8-story building located at 8000 Marina Boulevard, Brisbane, California 94005. | ||||||||||||||||
2.1.Premises: | Approximately 26,506 rentable square feet of space consisting of the entire fourth (4th) floor of the Building commonly known as Suite 400, as further set forth in Exhibit A to the Lease. | ||||||||||||||||
Lease Term (Article 2). | |||||||||||||||||
3.1Length of Term: | Six (6) years. | ||||||||||||||||
3.1Lease Commencement Date: | July 1, 2022. | ||||||||||||||||
3.1Lease Expiration Date: | June 30, 2028. | ||||||||||||||||
Base Rent (Article 3): | |||||||||||||||||
Lease Year | Annual Base Rent | Monthly Installment of Base Rent | Approximate Monthly Base Rent per Rentable Square Foot | ||||||||||||||
1* | $1,526,745.60 | $127,228.80 | $4.80 | ||||||||||||||
2 | $1,572,547.97 | $131,045.66 | $4.94 | ||||||||||||||
3 | $1,619,724.41 | $134,977.03 | $5.09 | ||||||||||||||
4 | $1,668,316.14 | $139,026.34 | $5.25 | ||||||||||||||
5 | $1,718,365.62 | $143,197.14 | $5.40 | ||||||||||||||
6 | $1,769,916.59 | $147,493.05 | $5.56 |
*Note: Tenant shall have no obligation to pay any Base Rent for the Premises attributable to the first four (4) full calendar months of the Lease Term (the “Base Rent Abatement Period”). | |||||||||||||||||
Tenant Improvement Allowance (Exhibit B): | An amount equal to $30.00 per rentable square foot of the Premises (i.e., $795,180.00 based upon 26,506 rentable square feet in the Premises). | ||||||||||||||||
Base Year (Article 4): | Calendar Year 2022. | ||||||||||||||||
Tenant’s Share (Article 4): | 13.13%. | ||||||||||||||||
Permitted Use (Article 5): | The Premises shall be used only for general office uses, including, but not limited to, administrative offices and other lawful uses reasonably related to or incidental to such specified uses, all (i) consistent with office projects in Brisbane, California, and (ii) in compliance with, and subject to, applicable laws and the terms of this Lease. | ||||||||||||||||
Security Deposit (Article 21): | $294,986.10. | ||||||||||||||||
Parking (Article 28): | 3 unreserved parking spaces for every 1,000 rentable square feet of the Premises, subject to the terms of Article 28 of the Lease, at no charge for the duration of the Lease Term, as the same may be extended. | ||||||||||||||||
Address of Tenant (Section 29.18): | CareDx, Inc. 11808 Miracle Hills Drive, Ste. 200 Omaha, Nebraska, 68154 and CareDX, Inc. 150 North Hill Drive, Suite 31 Brisbane, CA 94005 and CareDX, Inc. 3260 Bayshore Blvd. Brisbane, CA 94005 Attn: Legal |
-2- | [The Towers at Sierra Point] [CareDx, Inc.] |
Address of Landlord (Section 29.18): | See Section 29.18 of the Lease. | ||||||||||||||||
Broker(s) (Section 29.24): | CBRE, Inc. and Cushman & Wakefield |
-3- | [The Towers at Sierra Point] [CareDx, Inc.] |
-4- | [The Towers at Sierra Point] [CareDx, Inc.] |
-5- | [The Towers at Sierra Point] [CareDx, Inc.] |
-6- | [The Towers at Sierra Point] [CareDx, Inc.] |
-7- | [The Towers at Sierra Point] [CareDx, Inc.] |
-8- | [The Towers at Sierra Point] [CareDx, Inc.] |
-9- | [The Towers at Sierra Point] [CareDx, Inc.] |
-10- | [The Towers at Sierra Point] [CareDx, Inc.] |
-11- | [The Towers at Sierra Point] [CareDx, Inc.] |
-12- | [The Towers at Sierra Point] [CareDx, Inc.] |
-13- | [The Towers at Sierra Point] [CareDx, Inc.] |
-14- | [The Towers at Sierra Point] [CareDx, Inc.] |
-15- | [The Towers at Sierra Point] [CareDx, Inc.] |
-16- | [The Towers at Sierra Point] [CareDx, Inc.] |
-17- | [The Towers at Sierra Point] [CareDx, Inc.] |
-18- | [The Towers at Sierra Point] [CareDx, Inc.] |
-19- | [The Towers at Sierra Point] [CareDx, Inc.] |
-20- | [The Towers at Sierra Point] [CareDx, Inc.] |
Bodily Injury and Property Damage Liability | $5,000,000 each occurrence $5,000,000 annual aggregate | ||||
Personal Injury Liability | $3,000,000 each occurrence $3,000,000 annual aggregate |
-21- | [The Towers at Sierra Point] [CareDx, Inc.] |
-22- | [The Towers at Sierra Point] [CareDx, Inc.] |
-23- | [The Towers at Sierra Point] [CareDx, Inc.] |
-24- | [The Towers at Sierra Point] [CareDx, Inc.] |
-25- | [The Towers at Sierra Point] [CareDx, Inc.] |
-26- | [The Towers at Sierra Point] [CareDx, Inc.] |
-27- | [The Towers at Sierra Point] [CareDx, Inc.] |
-28- | [The Towers at Sierra Point] [CareDx, Inc.] |
-29- | [The Towers at Sierra Point] [CareDx, Inc.] |
-30- | [The Towers at Sierra Point] [CareDx, Inc.] |
-31- | [The Towers at Sierra Point] [CareDx, Inc.] |
-32- | [The Towers at Sierra Point] [CareDx, Inc.] |
-33- | [The Towers at Sierra Point] [CareDx, Inc.] |
-34- | [The Towers at Sierra Point] [CareDx, Inc.] |
-35- | [The Towers at Sierra Point] [CareDx, Inc.] |
-36- | [The Towers at Sierra Point] [CareDx, Inc.] |
-37- | [The Towers at Sierra Point] [CareDx, Inc.] |
-38- | [The Towers at Sierra Point] [CareDx, Inc.] |
-39- | [The Towers at Sierra Point] [CareDx, Inc.] |
-40- | [The Towers at Sierra Point] [CareDx, Inc.] |
LANDLORD: HCP LIFE SCIENCES REIT, INC., a Maryland corporation By: /s/ Scott Bohn Scott Bohn Print Name Its: Executive Vice President | TENANT: CAREDX, INC., a Delaware corporation By: /s/ Reginald Seeto, MBBS Reginald Seeto, MBBS Print Name Its: President and Chief Executive Officer By: ___________________________________ _______________________________________ Print Name Its: _____________________________________ |
-41- | [The Towers at Sierra Point] [CareDx, Inc.] |
[The Towers at Sierra Point] [CareDx, Inc.] |
(i) | [The Towers at Sierra Point] [CareDx, Inc.] |
(ii) | [The Towers at Sierra Point] [CareDx, Inc.] |
(iii) | [The Towers at Sierra Point] [CareDx, Inc.] |
Date: August 4, 2022 | By: | /s/ Reginald Seeto, MBBS | |||||||||
Reginald Seeto, MBBS | |||||||||||
Chief Executive Officer | |||||||||||
(Principal Executive Officer) |
Date: August 4, 2022 | By: | /s/ Abhishek Jain | |||||||||
Abhishek Jain | |||||||||||
Interim Chief Financial Officer | |||||||||||
(Principal Accounting and Financial Officer) |
By: | /s/ Reginald Seeto, MBBS | By: | /s/ Abhishek Jain | |||||||||||||||||
Reginald Seeto, MBBS | Abhishek Jain | |||||||||||||||||||
President and Chief Executive Officer | Interim Chief Financial Officer | |||||||||||||||||||
(Principal Executive Officer) | (Principal Accounting and Financial Officer) | |||||||||||||||||||
Date: August 4, 2022 | Date: August 4, 2022 |
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares |
Jun. 30, 2022 |
Dec. 31, 2021 |
---|---|---|
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) | 53,323,712 | 52,923,360 |
Common stock, shares outstanding (in shares) | 53,323,712 | 52,923,360 |
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2022 |
Jun. 30, 2021 |
Jun. 30, 2022 |
Jun. 30, 2021 |
|
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (21,697) | $ (1,927) | $ (41,345) | $ (2,614) |
Other comprehensive loss: | ||||
Foreign currency translation adjustments, net of tax | (2,092) | 443 | (2,512) | (1,060) |
Net comprehensive loss | $ (23,789) | $ (1,484) | $ (43,857) | $ (3,674) |
Condensed Consolidated Statements of Stockholders' Equity (Parenthetical) $ in Thousands |
3 Months Ended |
---|---|
Mar. 31, 2021
USD ($)
| |
Public Offering | |
Common stock, commissions and offering costs | $ 12,495 |
Organization and Description of Business |
6 Months Ended |
---|---|
Jun. 30, 2022 | |
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 Brisbane, 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, a donor-derived cell-free DNA (“dd-cfDNA”) solution for kidney transplant patients, AlloMap® Heart, a gene expression solution for heart transplant patients, AlloSure® Heart, a dd-cfDNA solution for heart transplant patients, and AlloSure® Lung, a dd-cfDNA solution for lung 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”) and XynManagement, Inc. (“XynManagement”), as well as the acquisitions of TransChart LLC (“TransChart”), MedActionPlan.com, LLC (“MedActionPlan”) and The Transplant Pharmacy, LLC (“TTP”) 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 commercial payers, 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. 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 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. 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. In March 2021, the Company acquired certain assets of 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. Patient and Digital Solutions Following the acquisitions of both Ottr and XynManagement, the Company is a leading provider of transplant patient management 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 ("SRTR") 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. 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 the Company's 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. In June 2021, the Company entered into a strategic agreement, which was amended in April 2022, 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. In November 2021, the Company acquired MedActionPlan, a New Jersey-based provider of medication safety, medication adherence and patient education. MedActionPlan is a leader in patient medication management for transplant patients and beyond. In December 2021, the Company acquired TTP, a transplant focused pharmacy located in Mississippi. TTP provides individualized transplant pharmacy services for patients at multiple transplant centers located throughout the U.S. COVID-19 Pandemic The full impact of the continued COVID-19 pandemic, including the impact associated with preventative and precautionary measures that the Company, other businesses and governments have taken and may take, 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. There continues to be uncertainty around the COVID-19 pandemic as the Omicron variant, including its sub-variants, has caused an increase in COVID-19 cases globally, impacted the availability of medical personnel in transplant centers and the volume of transplant procedures. A sustained reduction in transplant volume can negatively impact the testing volumes, as the Company saw in the early part of the first quarter of 2022. 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 regained normalized sales volumes during the fourth quarter of 2020. 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 could 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 created, and continues to have, a COVID-19 task force that is responsible for crisis decision making, employee communications, and enforcing all safety, monitoring and testing protocols in line with local regulations. 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 $424.5 million at June 30, 2022. As of June 30, 2022, the Company had cash, cash equivalents and marketable securities of $306.2 million and no debt outstanding. 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. 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.
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Summary of Significant Accounting Policies |
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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, 2021, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, filed with the Securities and Exchange Commission (the "SEC") on February 24, 2022. 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, 2021 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 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, 2021 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 six months ended June 30, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022. 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 patient and digital solutions revenue performance obligations; accrued expenses for clinical studies; inventory valuation; 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 or an asset acquisition; 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 June 30, 2022 and 2021, approximately 54% and 61%, respectively, of total revenue was derived from Medicare. For the six months ended June 30, 2022 and 2021, approximately 54% and 61%, respectively, of total revenue was derived from Medicare. As of June 30, 2022 and December 31, 2021, approximately 28% and 27%, respectively, of accounts receivable was due from Medicare. No other payer or customer represented more than 10% of accounts receivable at either June 30, 2022 or December 31, 2021. 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 June 30, 2022, 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, which were 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, 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, 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 June 30, 2022, 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. Unrealized gains and losses from the reevaluation of the long-term marketable debt securities, if any, are included in other comprehensive gain (loss) in the condensed consolidated statement of comprehensive income (loss). 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. 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 income (expense), net, in the condensed consolidated statements of operations. Leases The Company adopted Accounting Standard Codification (“ASC”) Topic 842, Leases, and 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 June 30, 2022, the Company’s leases had remaining terms of 0.04 years to 6.67 years, some of which include options to extend the lease term. Recent Accounting Pronouncements In November 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance, which contains amendments that require annual disclosures about transactions with a government that are accounted for by applying a grant or contribution accounting model. The disclosures include (1) the types of assistance, (2) an entity’s accounting for the assistance, and (3) the effect of the assistance on an entity’s financial statements. 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. The amendments in this ASU should be applied either (1) prospectively to all transactions within the scope of the amendments that are reflected in financial statements at the date of initial application and new transactions that are entered into after the date of initial application or (2) retrospectively to those transactions. The Company adopted the standard prospectively on January 1, 2022. The adoption of this new standard had no impact on the Company's consolidated financial statements and disclosures. In October 2021, the FASB issued ASU No. 2021-08, Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers, which requires that an entity recognize and measure contract assets and contract liabilities acquired in a business combination in accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). At the acquisition date, an acquirer should account for the related revenue contracts in accordance with ASC 606 as if it had originated the contracts. The amendments set forth in this ASU are effective for fiscal years beginning after December 15, 2022. Early adoption of the amendments is permitted. The amendments in this ASU should be applied prospectively to business combinations occurring on or after the effective date of the amendments. The Company early adopted the standard prospectively on January 1, 2022. The adoption of this new standard had no impact on the Company's 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 prospectively adopted the standard on January 1, 2022. The adoption of this new standard had no impact on the Company's consolidated financial statements and disclosures. In October 2020, the FASB issued 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 consolidated financial statements and disclosures.
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Net Loss Per Share |
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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 June 30, 2022 and 2021 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 tables set forth the Company’s financial assets and liabilities, measured at fair value on a recurring basis, as of June 30, 2022 and December 31, 2021 (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 June 30, 2022, 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 June 30, 2022 and December 31, 2021, 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. •Contingent consideration – Contingent consideration is classified within Level 3. Contingent consideration relates to asset acquisitions and business combinations. The Company recorded the estimate of the fair value of the contingent consideration based on its evaluation of the probability of the achievement of the contractual conditions that would result in the payment of the contingent consideration. Contingent consideration was estimated using the fair value of the milestones to be paid if the contingency is met multiplied by management’s estimate of the probability of success at a discounted rate of 12% at June 30, 2022 and December 31, 2021. The significant input in the Level 3 measurement that is not supported by market activity is the Company’s probability assessment of the achievement of the milestones. The value of the liability is subsequently remeasured to fair value at each reporting date, and the change in estimated fair value is recorded as a component of operating expenses until the milestones are paid, expire or are no longer achievable. Increases or decreases in the estimation of the probability percentage result in a directionally similar impact to the fair value measurement of the contingent consideration liability. The carrying amount of the contingent consideration liability represents its fair value. •Common stock warrant liability – Common stock warrant liability is classified within Level 3. The Company utilizes intrinsic value to estimate the fair value of the warrants. The intrinsic value is computed as the difference between the fair value of the Company’s common stock on the valuation date and the exercise price of the warrants. Increases (decreases) in the Company's stock price discussed above result in a directionally similar impact to the fair value of the common stock warrant liability. Prior to fiscal year 2022, the Company utilized a binomial lattice pricing model (the "Monte Carlo Simulation Model") which 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 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. The change in valuation method does not have material financial impact. Common Stock Warrant Liability Valuation Assumptions Utilized at June 30, 2022 and December 31, 2021:
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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 June 30, 2022. At June 30, 2022, 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 June 30, 2022. All short-term marketable securities with unrealized losses as of the balance sheet date have been in a loss position for less than twelve months. Contractual maturities of the short-term marketable securities were within one year or less at June 30, 2022. The long-term marketable equity securities were recorded at fair market value at June 30, 2022 and December 31, 2021. The long-term marketable debt securities were considered available-for-sale at June 30, 2022 and December 31, 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 |
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Business Combination and Asset Acquisition [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Business Combinations | BUSINESS COMBINATIONS The Transplant Pharmacy In December 2021, the Company acquired TTP, a transplant focused pharmacy located in Mississippi. The Company acquired TTP with a combination of cash consideration paid upfront and contingent consideration with a fair value of $1.3 million. TTP provides individualized transplant pharmacy services for patients at multiple transplant centers located throughout the U.S. The Company accounted for the transaction as a business combination using the acquisition method of accounting. Acquisition-related costs of $0.3 million were expensed as incurred, and classified as part of general and administrative expenses in the condensed consolidated statements of operations. Goodwill of $5.5 million arising from the acquisition primarily consists of additional growth opportunities within the pharmacy sector. The integration of TTP into the Company’s portfolio is expected to continue to increase the transplant ecosystem for patients and make medication more accessible. The Company estimated net deferred tax liabilities of approximately $0.6 million arising from temporary differences related to the assets acquired and liabilities assumed. None of the goodwill is expected to be deductible for income tax purposes. All of the goodwill has been assigned to the Company’s existing operating segment. The following table summarizes the fair value of the intangible asset acquired as of the acquisition date ($ in thousands):
The trademark acquired consists primarily of the TTP brand and markings. The fair value of the trademark was determined using the relief-from-royalty method under the income approach. This method considers the value of the asset to be the value of the royalty payments from which the Company is relieved due to its ownership of the asset. The royalty rate of 2% was used to estimate the fair value of the trademark. A discount rate of 13.5% was utilized in estimating the fair value of the trademark. The pro forma impact of the TTP 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. MedActionPlan In November 2021, the Company acquired MedActionPlan, a New Jersey-based provider of medication safety, medication adherence and patient education. The Company acquired MedActionPlan with a combination of cash consideration paid upfront and contingent consideration with a fair value of $3.5 million. MedActionPlan is a leader in patient medication management for transplant patients and beyond. The Company accounted for the transaction as a business combination using the acquisition method of accounting. Acquisition-related costs of $0.6 million associated with the acquisition were expensed as incurred, and classified as part of general and administrative expenses in the condensed consolidated statement of operations. Goodwill of $4.9 million arising from the acquisition primarily consists of synergies from integrating the MedActionPlan technology with the current testing and digital solutions offered by the Company. The integration of MedActionPlan into centers with the Company's other software platforms will continue to increase the standard of care for transplant patient safety, increase efficiency and facilitate medication compliance. None of the goodwill is expected to be deductible for income tax purposes. All of the goodwill has been assigned to the Company’s existing operating segment. The following table summarizes the fair values of the intangible assets acquired as of the acquisition date ($ in thousands):
Customer relationships acquired by the Company represent the fair value of future projected revenue that is expected to be derived from sales of MedActionPlan’s products to existing customers. The customer relationships’ fair value has been estimated utilizing a multi-period excess earnings method under the income approach, which reflects the present value of the projected cash flows that are expected to be generated by the customer relationships, less charges representing the contribution of other assets to those cash flows that use projected cash flows with and without the intangible asset in place. The economic useful life was determined based on the distribution of the present value of the cash flows attributable to the intangible asset. The acquired developed technology represents the fair value of MedActionPlan’s proprietary software. The trademark acquired consists primarily of the MedActionPlan brand and markings. The fair value of both the developed technology and the trademark were determined using the relief-from-royalty method under the income approach. This method considers the value of the asset to be the value of the royalty payments from which the Company is relieved due to its ownership of the asset. The royalty rates of 15% and 1% were used to estimate the fair value of the developed technology and the trademark, respectively. A discount rate of 40.0% was utilized in estimating the fair value of these three intangible assets. The pro forma impact of the MedActionPlan 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. 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. Combined Consideration Paid The following table summarizes the consideration paid for TTP, MedActionPlan and TransChart, and the provisional amounts of the assets acquired and liabilities assumed recognized at their estimated fair value at the acquisition date (in thousands):
The allocation of the purchase price to assets acquired and liabilities assumed was based on the Company’s best estimate of the fair value of such assets and liabilities as of the 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 six months ended June 30, 2022. The balance of the Company's goodwill was $37.1 million and $37.0 million as of June 30, 2022 and December 31, 2021, respectively. Intangible Assets The following table presents details of the Company’s intangible assets as of June 30, 2022 ($ in thousands):
The following table presents details of the Company’s intangible assets as of December 31, 2021 ($ in thousands):
Acquisition of Intangible Assets In June 2021and June 2022, 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 June 30, 2022. In June 2021, the Company acquired the Transplant Hero patient application. The patient application is included in Acquired and developed technology as of June 30, 2022. In the fourth quarter of 2021, acquisition of intangible assets increased $13.4 million primarily from business combinations. These acquisitions included $4.7 million of Acquired and developed technology, $2.5 million of Commercialization rights, $3.7 million of Customer relationships, $2.2 million of Trademarks and tradenames and $0.3 million of Other intangible assets. Amortization of Intangible Assets Intangible assets are carried at cost less accumulated amortization. Amortization expenses are recorded to cost of testing services, cost of product, cost of patient and digital solutions, and sales and marketing expenses in the condensed consolidated statements of operations. The following table summarizes the Company's amortization expense of intangible assets (in thousands):
The following table summarizes the Company’s estimated future amortization expense of intangible assets with finite lives as of June 30, 2022 (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 ProvidersOn 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.
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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 Brisbane, California; Columbus, Ohio; West Chester, Pennsylvania; Flowood, Mississippi; Gaithersburg, Maryland; Fremantle, Australia; and Stockholm, Sweden. 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 June 30, 2022, the carrying value of the ROU asset was $15.8 million. The related current and non-current liabilities as of June 30, 2022 were $3.0 million and $16.1 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 six months ended June 30, 2022 and 2021 (in thousands):
Finance lease cost includes interest from the lease liability and amortization of the ROU asset.
Maturities of operating lease liabilities as of June 30, 2022 are as follows (in thousands):
In June 2022, the Company signed a termination agreement (the "Termination Agreement") for its headquarters office lease in South San Francisco, California (the "South San Francisco Lease"). Pursuant to the Termination Agreement, the termination date for the South San Francisco Lease was modified from December 31, 2022 to July 15, 2022. As a result of such modification, the Company remeasured its lease liability using the current incremental borrowing rate and made an adjustment by reducing the ROU asset and lease liability by $0.5 million. In July 2022, the Company moved and relocated its headquarters from South San Francisco, California to Brisbane, California. Also, in June 2022, the Company renewed the lease agreement for its offices in Fremantle, Australia, and extended the lease term for two years through May 2024. 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, Inc. (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 iBox. Other Commitments Pursuant to the Illumina Agreement, the Company has agreed to minimum purchase commitments of finished products and raw materials from Illumina, Inc. 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 commenced on March 7, 2022 and concluded on March 14, 2022, with the jury awarding the Company $44.9 million in damages, comprised of $21.2 million in compensatory damages and $23.7 million in punitive damages. Post-trial motion practice remains pending. The Company will not record the award until cash is received or the matter is otherwise resolved. On July 19, 2022, the Federal Circuit court of appeals affirmed the district court’s judgment dismissing the Company’s patent infringement suit against Natera. 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. This case was consolidated with the Company’s patent infringement suit on February 4, 2020. 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. On May 13, 2022, Natera filed two new complaints alleging that AlloSure infringes Natera’s U.S. Patents 10,655,180 and 11,111,544. These two cases were consolidated with the patent infringement case on June 15, 2022. On May 17, 2022, Natera agreed to dismiss the case alleging infringement of Natera’s U.S. Patent 10,526,658. On July 6, 2022, the Company moved to dismiss the rest of Natera’s claims. The motion remains pending. 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 As previously disclosed, in 2021, the Company 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 the Company's 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 the Company's 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 regulatory agency 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. Olymbios Matter On April 15, 2022, a complaint was filed by Michael Olymbios against the Company in the Superior Court of the State of California for the County of San Mateo (the “San Mateo County Court”). The complaint alleges that the Company failed to pay certain fees and costs required to continue an arbitration proceeding against Dr. Olymbios, and that the Company has defamed Dr. Olymbios. Dr. Olymbios also seeks to void restrictive covenants previously agreed to by him in favor of the Company and to recover damages purportedly incurred by Dr. Olymbios. The Company filed a motion to compel arbitration and dismiss the case. On April 25, 2022, the San Mateo County Court granted the Company’s ex parte application to stay the case and advance the hearing date to June 10, 2022 for the motion to compel arbitration and dismiss. At the June 10, 2022 hearing, the San Mateo County Court found that the decision should be made by the arbitrator, and stayed the case. The arbitration hearing is currently set for October 27, 2022. The Company intends to defend itself vigorously. The Company believes it has good and substantial defenses to the claims alleged in the suit, but there is no guarantee that the Company will prevail if the case continues. The Company has not recorded any liabilities for this suit. Securities Class Action On May 23, 2022, Plumbers & Pipefitters Local Union #295 Pension Fund filed a federal securities class action in the U.S. District Court for the Northern District of California against the Company, Reginald Seeto, its President, Chief Executive Officer and member of the Company’s Board of Directors, Ankur Dhingra, its former Chief Financial Officer, Marcel Konrad, its former interim Chief Financial Officer and former Senior Vice President of Finance & Accounting, and Peter Maag, its former President, former Chief Executive Officer, former Chairman of the Board and current member of the Company’s Board of Directors. The action alleges that the Company and the individual defendants made materially false and/or misleading statements and/or omissions and that such statements violated Section 10(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Rule 10b-5 promulgated thereunder. The action also alleges that the individual defendants are liable pursuant to Section 20(a) of the Exchange Act as controlling persons of the Company. The suit seeks to recover damages caused by the alleged violations of federal securities laws, along with the plaintiffs’ costs incurred in the lawsuit, including their reasonable attorneys’ and experts’ witness fees and other costs. The Company intends to defend itself vigorously, and believes that the Company has good and substantial defenses to the claims alleged in the suit, but there is no guarantee that the Company will prevail. The Company has not recorded any liabilities for this suit.
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401(K) Plan |
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Jun. 30, 2022 | |
Retirement Benefits [Abstract] | |
401(K) Plan | 401(K) PLANThe Company sponsors a | defined contribution plan (the "401(k) Plan") covering all U.S. employees under the Internal Revenue Code of 1986, as amended. Employee contributions to the 401(k) Plan 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 401(k) Plan of $0.5 million and $0.3 million for the three months ended June 30, 2022 and 2021, respectively. The Company incurred expenses related to contributions to the plan of $1.2 million and $0.8 million for the six months ended June 30, 2022 and 2021, 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 and six months ended June 30, 2022, no warrants to purchase shares of common stock were exercised. In the three and six months ended June 30, 2021, warrants to purchase approximately 3,000 shares of common stock were exercised for cash proceeds of $4 thousand. As of June 30, 2022, outstanding warrants to purchase common stock were:
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Stock Incentive Plans |
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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 $0.3 million and $1.3 million for the three and six months ended June 30, 2022, respectively. The total intrinsic value of options exercised was $25.9 million and $35.0 million for the three and six months ended June 30, 2021, respectively. As of June 30, 2022, the total intrinsic value of outstanding RSUs was approximately $55.7 million and there were $91.7 million of unrecognized compensation costs related to RSUs, which are expected to be recognized over a weighted-average period of 2.95 years. Options outstanding that have vested and are expected to vest at June 30, 2022 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 June 30, 2022 for stock options that were in-the-money. The total fair value of options that vested during the three and six months ended June 30, 2022 was $2.4 million and $6.3 million, respectively. As of June 30, 2022, there were approximately $28.8 million of unrecognized compensation costs related to stock options, which are expected to be recognized over a weighted-average period of 2.96 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 2022 that ended on June 30, 2022, 67,570 shares were purchased pursuant to the ESPP for aggregate proceeds of $1.2 million from the issuance of such shares, which occurred on July 1, 2022. During the offering period in 2021 that ended on December 31, 2021, 25,852 shares were purchased pursuant to the ESPP for aggregate proceeds of $1.0 million from the issuance of such shares, which occurred on January 6, 2022. 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. 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 six months ended June 30, 2022 and 2021, 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 |
6 Months Ended |
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Jun. 30, 2022 | |
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 six months ended June 30, 2022, the Company recorded an income tax benefit of $49 thousand and $61 thousand, respectively. For the three and six months ended June 30, 2021, the Company recorded an income tax benefit of $0.1 million and $0.4 million, respectively. The income tax benefit of $49 thousand and $61 thousand for the three and six months ended June 30, 2022 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 net deferred tax assets of its Australian operations. Accordingly, the U.S. and Australian net deferred tax assets have been offset by a full valuation allowance.
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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, the region of testing for testing services revenue, and the region of services provided for patient and digital solutions revenue. The following table summarizes reportable revenues by geographic regions (in thousands):
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Summary of Significant Accounting Policies (Policies) |
6 Months Ended |
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Jun. 30, 2022 | |
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 $424.5 million at June 30, 2022. As of June 30, 2022, the Company had cash, cash equivalents and marketable securities of $306.2 million and no debt outstanding. 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.
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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 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, 2021 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 six months ended June 30, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022.
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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 patient and digital solutions revenue performance obligations; accrued expenses for clinical studies; inventory valuation; 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 or an asset acquisition; 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 June 30, 2022 and 2021, approximately 54% and 61%, respectively, of total revenue was derived from Medicare. For the six months ended June 30, 2022 and 2021, approximately 54% and 61%, respectively, of total revenue was derived from Medicare. As of June 30, 2022 and December 31, 2021, approximately 28% and 27%, respectively, of accounts receivable was due from Medicare. No other payer or customer represented more than 10% of accounts receivable at either June 30, 2022 or December 31, 2021.
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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 June 30, 2022, 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, which were 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, 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, 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 June 30, 2022, 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. Unrealized gains and losses from the reevaluation of the long-term marketable debt securities, if any, are included in other comprehensive gain (loss) in the condensed consolidated statement of comprehensive income (loss). 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. 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 income (expense), net, in the condensed consolidated statements of operations.
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Leases | Leases The Company adopted Accounting Standard Codification (“ASC”) Topic 842, Leases, and 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 June 30, 2022, the Company’s leases had remaining terms of 0.04 years to 6.67 years, some of which include options to extend the lease term.
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Recent Accounting Pronouncements | Recent Accounting Pronouncements In November 2021, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance, which contains amendments that require annual disclosures about transactions with a government that are accounted for by applying a grant or contribution accounting model. The disclosures include (1) the types of assistance, (2) an entity’s accounting for the assistance, and (3) the effect of the assistance on an entity’s financial statements. 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. The amendments in this ASU should be applied either (1) prospectively to all transactions within the scope of the amendments that are reflected in financial statements at the date of initial application and new transactions that are entered into after the date of initial application or (2) retrospectively to those transactions. The Company adopted the standard prospectively on January 1, 2022. The adoption of this new standard had no impact on the Company's consolidated financial statements and disclosures. In October 2021, the FASB issued ASU No. 2021-08, Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers, which requires that an entity recognize and measure contract assets and contract liabilities acquired in a business combination in accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). At the acquisition date, an acquirer should account for the related revenue contracts in accordance with ASC 606 as if it had originated the contracts. The amendments set forth in this ASU are effective for fiscal years beginning after December 15, 2022. Early adoption of the amendments is permitted. The amendments in this ASU should be applied prospectively to business combinations occurring on or after the effective date of the amendments. The Company early adopted the standard prospectively on January 1, 2022. The adoption of this new standard had no impact on the Company's 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 prospectively adopted the standard on January 1, 2022. The adoption of this new standard had no impact on the Company's consolidated financial statements and disclosures. In October 2020, the FASB issued 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 consolidated financial statements and disclosures.
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Net Loss Per Share (Tables) |
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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 June 30, 2022 and 2021 because their effect would be antidilutive:
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Fair Value Measurements (Tables) |
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Fair Value Disclosures [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Fair Value of Financial Assets and Liabilities Measured on Recurring Basis | The following tables set forth the Company’s financial assets and liabilities, measured at fair value on a recurring basis, as of June 30, 2022 and December 31, 2021 (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 and Derivative Liability Valuation Assumptions | Common Stock Warrant Liability Valuation Assumptions Utilized at June 30, 2022 and December 31, 2021:
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Cash and Marketable Securities (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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Business Combinations (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Business Combination and Asset Acquisition [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Identified Intangible Assets Acquired at Acquisition Date | The following table summarizes the fair value of the intangible asset acquired as of the acquisition date ($ in thousands):
The following table summarizes the fair values of the intangible assets acquired as of the acquisition date ($ in thousands):
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Summary of Fair Values of Assets Acquired and Liabilities Assumed as of Acquisition Date | The following table summarizes the consideration paid for TTP, MedActionPlan and TransChart, and the provisional amounts of the assets acquired and liabilities assumed recognized at their estimated fair value at the acquisition date (in thousands):
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Goodwill and Intangible Assets (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Goodwill and Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Intangible Assets | The following table presents details of the Company’s intangible assets as of June 30, 2022 ($ in thousands):
The following table presents details of the Company’s intangible assets as of December 31, 2021 ($ in thousands):
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Summary of Estimated Future Amortization Expense of Intangible Assets | The following table summarizes the Company's amortization expense of intangible assets (in thousands):
The following table summarizes the Company’s estimated future amortization expense of intangible assets with finite lives as of June 30, 2022 (in thousands):
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Balance Sheet Components (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Commitments and Contingencies Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Lease Cost | The following table summarizes the lease cost for the three and six months ended June 30, 2022 and 2021 (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 June 30, 2022 are as follows (in thousands):
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Warrants (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Warrants and Rights Note Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Components of Warrants Outstanding | As of June 30, 2022, outstanding warrants to purchase common stock were:
|
Stock Incentive Plans (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Share-Based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Options, RSUs Activity under 2014 Equity Incentive Plan and 2016 Inducement 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 June 30, 2022 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 six months ended June 30, 2022 and 2021, included in the condensed consolidated statements of operations as follows (in thousands):
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Segment Reporting (Tables) |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Segment Reporting [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reportable Revenues by Geographic Regions | 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 (Details) - Medicare |
3 Months Ended | 6 Months Ended | 12 Months Ended | ||
---|---|---|---|---|---|
Jun. 30, 2022 |
Jun. 30, 2021 |
Jun. 30, 2022 |
Jun. 30, 2021 |
Dec. 31, 2021 |
|
Revenue Benchmark | Customer Concentration Risk | |||||
Concentration Risk [Line Items] | |||||
Concentration risk percentage | 54.00% | 61.00% | 54.00% | 61.00% | |
Accounts Receivable | Credit Concentration Risk | |||||
Concentration Risk [Line Items] | |||||
Concentration risk percentage | 28.00% | 27.00% |
Summary of Significant Accounting Policies - Leases (Details) |
6 Months Ended |
---|---|
Jun. 30, 2022 | |
Minimum | |
Summary Of Significant Accounting Policies [Line Items] | |
Remaining lease terms | 14 days |
Maximum | |
Summary Of Significant Accounting Policies [Line Items] | |
Remaining lease terms | 6 years 8 months 1 day |
Net Loss Per Share - Computation of Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2022 |
Jun. 30, 2021 |
Jun. 30, 2022 |
Jun. 30, 2021 |
|
Numerator: | ||||
Net loss used to compute basic net loss per share | $ (21,697) | $ (1,927) | $ (41,345) | $ (2,614) |
Net loss used to compute diluted net loss per share | $ (21,697) | $ (1,927) | $ (41,345) | $ (2,614) |
Denominator: | ||||
Weighted-average shares used to compute basic net loss per share (in shares) | 53,249,545 | 52,224,300 | 53,133,149 | 51,705,587 |
Weighted-average shares used to compute diluted net loss per share (in shares) | 53,249,545 | 52,224,300 | 53,133,149 | 51,705,587 |
Net loss per share: | ||||
Basic (in dollars per share) | $ (0.41) | $ (0.04) | $ (0.78) | $ (0.05) |
Diluted (in dollars per share) | $ (0.41) | $ (0.04) | $ (0.78) | $ (0.05) |
Fair Value Measurements - Summary of Issuances, Exercises, Changes in Fair Value and Reclassifications of Level 3 Financial Instruments (Details) $ in Thousands |
6 Months Ended |
---|---|
Jun. 30, 2022
USD ($)
| |
Common Stock Warrant Liability and Contingent Consideration | |
Beginning balance | $ 5,480 |
Ending balance | 5,719 |
Common Stock Warrant Liability | |
Common Stock Warrant Liability and Contingent Consideration | |
Change in estimated fair value of common stock warrant liability | (75) |
Contingent Consideration | |
Common Stock Warrant Liability and Contingent Consideration | |
Change in estimated fair value of common stock warrant liability | 564 |
Payments related to contingent consideration | $ (250) |
Fair Value Measurements - Narratives (Details) |
6 Months Ended | 12 Months Ended |
---|---|---|
Jun. 30, 2022
investment
|
Dec. 31, 2021 |
|
Fair Value Disclosures [Abstract] | ||
Number of investments | 1 | |
Contingent consideration, measurement input, discount rate | 0.12 | 0.12 |
Fair Value Measurements - Summary of Common Stock Warrant Liability Valuation Assumptions (Details) - Private Placement Common Stock Warrant Liability |
6 Months Ended | 12 Months Ended |
---|---|---|
Jun. 30, 2022
$ / shares
|
Dec. 31, 2021
$ / shares
|
|
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Stock price (in dollars per share) | $ 21.48 | $ 45.48 |
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) | 9 months 14 days | 1 year 3 months 10 days |
Volatility | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability measurement input (percent) | 0.6600 | |
Risk-free interest rate | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Derivative liability measurement input (percent) | 0.0049 |
Cash and Marketable Securities - Reconciliation of Cash and Cash Equivalents (Details) - USD ($) $ in Thousands |
Jun. 30, 2022 |
Dec. 31, 2021 |
Jun. 30, 2021 |
Dec. 31, 2020 |
---|---|---|---|---|
Cash and Cash Equivalents [Abstract] | ||||
Cash and cash equivalents | $ 166,832 | $ 348,485 | $ 335,625 | |
Restricted cash | 204 | 211 | 268 | |
Total cash, cash equivalents, and restricted cash at the end of the period | $ 167,036 | $ 348,696 | $ 335,893 | $ 134,939 |
Cash and Marketable Securities - Schedule of Maturity (Details) - USD ($) $ in Thousands |
Jun. 30, 2022 |
Dec. 31, 2021 |
---|---|---|
Cash and Cash Equivalents [Abstract] | ||
Within one year | $ 139,388 | $ 0 |
After one year through five years | 500 | 500 |
Debt securities, amortized cost | $ 139,888 | $ 500 |
Business Combinations - Summary of Consideration Paid and Provisional Amounts of Assets Acquired and Liabilities Assumed Recognized at Their Estimated Fair Value (Details) - USD ($) $ in Thousands |
12 Months Ended | |
---|---|---|
Dec. 31, 2021 |
Jun. 30, 2022 |
|
Business Acquisition [Line Items] | ||
Goodwill | $ 36,983 | $ 37,084 |
TransChart, TTP, and MedActionPlan | ||
Business Acquisition [Line Items] | ||
Cash | 17,166 | |
Total consideration | 17,166 | |
Current assets | 3,444 | |
Fixed assets | 23 | |
Identifiable intangible assets | 7,860 | |
Other assets | 2 | |
Current liabilities | (3,915) | |
Noncurrent liabilities | (2,883) | |
Total identifiable net assets acquired | 4,531 | |
Goodwill | 12,635 | |
Total consideration | $ 17,166 |
Goodwill and Intangible Assets - Additional Information (Details) - USD ($) $ in Thousands |
3 Months Ended | |
---|---|---|
Dec. 31, 2021 |
Jun. 30, 2022 |
|
Goodwill And Intangible Assets [Line Items] | ||
Goodwill | $ 36,983 | $ 37,084 |
Assets acquired | 13,400 | |
Acquired and developed technology | ||
Goodwill And Intangible Assets [Line Items] | ||
Assets acquired | 4,700 | |
Commercialization rights | ||
Goodwill And Intangible Assets [Line Items] | ||
Assets acquired | 2,500 | |
Customer relationships | ||
Goodwill And Intangible Assets [Line Items] | ||
Assets acquired | 3,700 | |
Trademarks and tradenames | ||
Goodwill And Intangible Assets [Line Items] | ||
Assets acquired | 2,200 | |
Other | ||
Goodwill And Intangible Assets [Line Items] | ||
Assets acquired | $ 300 |
Goodwill and Intangible Assets - Schedule of Amortization Expense of Intangible Assets (Details) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2022 |
Jun. 30, 2021 |
Jun. 30, 2022 |
Jun. 30, 2021 |
|
Goodwill And Intangible Assets [Line Items] | ||||
Amortization expense of intangible assets | $ 1,545 | $ 1,429 | $ 3,168 | $ 2,703 |
Cost of Testing Services | ||||
Goodwill And Intangible Assets [Line Items] | ||||
Amortization expense of intangible assets | 329 | 350 | 658 | 658 |
Cost of Product | ||||
Goodwill And Intangible Assets [Line Items] | ||||
Amortization expense of intangible assets | 437 | 489 | 890 | 954 |
Cost of Patient and Digital Solutions | ||||
Goodwill And Intangible Assets [Line Items] | ||||
Amortization expense of intangible assets | 236 | 141 | 472 | 249 |
Sales and Marketing Expense | ||||
Goodwill And Intangible Assets [Line Items] | ||||
Amortization expense of intangible assets | $ 543 | $ 449 | $ 1,148 | $ 842 |
Balance Sheet Components - Summary of Inventory (Details) - USD ($) $ in Thousands |
Jun. 30, 2022 |
Dec. 31, 2021 |
---|---|---|
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Finished goods | $ 3,602 | $ 3,911 |
Work in progress | 3,944 | 2,828 |
Raw materials | 11,315 | 10,447 |
Total inventory | $ 18,861 | $ 17,186 |
Balance Sheet Components - Components of Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands |
Jun. 30, 2022 |
Dec. 31, 2021 |
---|---|---|
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Clinical studies | $ 13,325 | $ 10,653 |
Professional fees | 8,257 | 5,780 |
Deferred revenue | 4,295 | 4,208 |
Short-term lease liability | 2,989 | 3,958 |
Deferred payments for intangible assets | 2,906 | 2,000 |
Contingent consideration | 2,778 | 2,114 |
Capital expenditures | 2,537 | 2,612 |
Laboratory processing fees & materials | 2,400 | 1,888 |
Accrued royalty | 1,560 | 1,664 |
Accrued shipping expenses | 704 | 670 |
Other accrued expenses | 5,182 | 2,375 |
Total accrued and other liabilities | $ 46,933 | $ 37,922 |
Balance Sheet Components - Additional Information (Details) $ in Millions |
1 Months Ended |
---|---|
Apr. 30, 2020
USD ($)
| |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Proceeds from advance payment | $ 20.5 |
Commitments and Contingencies - Additional Information (Details) $ in Thousands |
1 Months Ended | ||||
---|---|---|---|---|---|
May 13, 2022
complaint
|
Mar. 14, 2022
USD ($)
|
Jun. 30, 2022
USD ($)
|
Jun. 30, 2014
milestone_payment
|
Dec. 31, 2021
USD ($)
|
|
Loss Contingencies [Line Items] | |||||
Operating lease right-of-use asset | $ 15,841 | $ 17,993 | |||
Short-term lease liability | 2,989 | 3,958 | |||
Operating lease liability, less current portion | 16,065 | $ 17,394 | |||
Number of milestone payments | milestone_payment | 6 | ||||
Derecognition of ROU and lease liability | $ 500 | ||||
Operating lease, extension period | 2 years | ||||
CAREDX, INC. vs Natera Inc. | |||||
Loss Contingencies [Line Items] | |||||
Damages awarded | $ 44,900 | ||||
Number of complaints | complaint | 2 | ||||
CAREDX, INC. vs Natera Inc. | Compensatory Damages | |||||
Loss Contingencies [Line Items] | |||||
Damages awarded | 21,200 | ||||
CAREDX, INC. vs Natera Inc. | Punitive Damages | |||||
Loss Contingencies [Line Items] | |||||
Damages awarded | $ 23,700 |
Commitments and Contingencies - Summary of Lease Cost (Details) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2022 |
Jun. 30, 2021 |
Jun. 30, 2022 |
Jun. 30, 2021 |
|
Commitments and Contingencies Disclosure [Abstract] | ||||
Operating lease cost | $ 1,372 | $ 1,207 | $ 2,785 | $ 2,412 |
Finance lease cost | 0 | 23 | 0 | 53 |
Total lease cost | $ 1,372 | $ 1,230 | $ 2,785 | $ 2,465 |
Commitments and Contingencies - Summary of Other Information Related to Lease (Details) |
Jun. 30, 2022 |
---|---|
Other information: | |
Weighted-average remaining lease term - Operating leases (in years) | 5 years 9 months 3 days |
Weighted-average discount rate - Operating leases (%) | 9.90% |
Commitments and Contingencies - Future Minimum Lease Commitments under Operating and Finance Leases (Details) - USD ($) $ in Thousands |
Jun. 30, 2022 |
Dec. 31, 2021 |
---|---|---|
Operating Leases | ||
Remainder of 2022 | $ 2,305 | |
2023 | 4,495 | |
2024 | 4,318 | |
2025 | 3,955 | |
2026 | 3,196 | |
Thereafter | 7,140 | |
Total lease payments | 25,409 | |
Less imputed interest | 6,355 | |
Present value of future minimum lease payments | 19,054 | |
Less operating lease liability, current portion | 2,989 | $ 3,958 |
Operating lease liability, long-term portion | $ 16,065 | $ 17,394 |
401(K) Plan - Additional Information (Detail) - USD ($) $ in Millions |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2022 |
Jun. 30, 2021 |
Jun. 30, 2022 |
Jun. 30, 2021 |
|
Retirement Benefits [Abstract] | ||||
Defined Benefit Plan, Type | Postemployment Retirement Benefits [Member] | |||
Expense incurred related to plan | $ 0.5 | $ 0.3 | $ 1.2 | $ 0.8 |
Warrants - Additional Information (Detail) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2022 |
Jun. 30, 2021 |
Jun. 30, 2022 |
Jun. 30, 2021 |
|
Warrants and Rights Note Disclosure [Abstract] | ||||
Number of warrants exercised (in shares) | 0 | 3,000 | 0 | 3,000 |
Proceeds from exercise of warrants | $ 4 | $ 0 | $ 4 |
Warrants - Outstanding Warrants To Purchase Common Stock Warrants (Detail) - Common Stock |
6 Months Ended |
---|---|
Jun. 30, 2022
$ / shares
shares
| |
Class of Warrant or Right [Line Items] | |
Exercise price (in dollars per share) | $ / shares | $ 1.12 |
Number of shares underlying warrants (in shares) | shares | 3,132 |
Original Term | |
Class of Warrant or Right [Line Items] | |
Original Term (in years) | 7 years |
Stock Incentive Plans - Summary of Options Outstanding Vested and Expected to Vest (Detail) $ / shares in Units, shares in Thousands, $ in Thousands |
6 Months Ended |
---|---|
Jun. 30, 2022
USD ($)
$ / shares
shares
| |
Share-Based Payment Arrangement [Abstract] | |
Vested (in shares) | shares | 1,134 |
Expected to vest (in shares) | shares | 1,260 |
Total (in shares) | shares | 2,394 |
Vested (in dollars per share) | $ / shares | $ 23.80 |
Expected to vest (in dollars per share) | $ / shares | $ 36.21 |
Vested, weighted average remaining life | 6 years 4 months 6 days |
Expected to vest, weighted average remaining contractual life | 9 years 7 days |
Vested, aggregate intrinsic value | $ | $ 5,857 |
Expected to vest, aggregate intrinsic value | $ | 637 |
Aggregate Intrinsic Value, Total | $ | $ 6,494 |
Stock Incentive Plans - Weighted-Average Assumptions Used to Estimated Fair Values of Share-Based Awards (Detail) |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2022 |
Jun. 30, 2021 |
Jun. 30, 2022 |
Jun. 30, 2021 |
|
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 | 67.79% | 53.10% | 67.79% | 53.10% |
Risk-free interest rate | 2.51% | 0.09% | 2.51% | 0.09% |
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) | 5 years 10 months 24 days | 5 years 7 months 6 days | 5 years 10 months 24 days | 5 years 10 months 24 days |
Expected volatility | 76.94% | 78.07% | 76.94% | 77.78% |
Risk-free interest rate | 2.88% | 1.03% | 2.41% | 0.76% |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands |
3 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jun. 30, 2022 |
Jun. 30, 2021 |
Jun. 30, 2022 |
Jun. 30, 2021 |
|
Income Tax Disclosure [Abstract] | ||||
Income tax benefit | $ 49 | $ 100 | $ 61 | $ 363 |
Segment Reporting - Long-Lived Assets Consisting of Property and Equipment, Net by Geographic Regions (Detail) - USD ($) $ in Thousands |
Jun. 30, 2022 |
Dec. 31, 2021 |
---|---|---|
Segment Reporting Information [Line Items] | ||
Long-lived assets | $ 32,904 | $ 22,044 |
United States | ||
Segment Reporting Information [Line Items] | ||
Long-lived assets | 32,321 | 21,444 |
Europe | ||
Segment Reporting Information [Line Items] | ||
Long-lived assets | 441 | 403 |
Rest of World | ||
Segment Reporting Information [Line Items] | ||
Long-lived assets | $ 142 | $ 197 |
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