Delaware | 001-36536 | 94-3316839 | ||||||||||||
(State or Other Jurisdiction
of Incorporation)
|
(Commission
File Number)
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(IRS Employer
Identification No.)
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☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
(Title of each class) | (Trading Symbol) | (Name of exchange on which registered) | ||||||||||||
Common Stock, $0.001 Par Value | CDNA | The Nasdaq Stock Market LLC |
Exhibit No. | Description | |||||||
99.1 | ||||||||
104 | Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL). |
Date: February 28, 2024 |
CAREDX, INC.
|
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By: | /s/ Abhishek Jain | |||||||||||||||||||
Abhishek Jain | ||||||||||||||||||||
Chief Financial Officer |
Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
Revenue: | |||||||||||||||||||||||
Testing services revenue | $ | 46,703 | $ | 65,418 | $ | 209,685 | $ | 263,748 | |||||||||||||||
Product revenue | 9,244 | 8,555 | 33,517 | 29,251 | |||||||||||||||||||
Patient and digital solutions | 9,622 | 8,411 | 37,122 | 28,794 | |||||||||||||||||||
Total revenue | 65,569 | 82,384 | 280,324 | 321,793 | |||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||
Cost of testing services | 13,805 | 18,657 | 57,642 | 72,286 | |||||||||||||||||||
Cost of product | 5,637 | 4,617 | 18,379 | 17,639 | |||||||||||||||||||
Cost of patient and digital solutions | 6,171 | 6,216 | 25,978 | 22,287 | |||||||||||||||||||
Research and development | 18,276 | 23,570 | 81,866 | 90,388 | |||||||||||||||||||
Sales and marketing | 19,999 | 23,668 | 83,334 | 96,027 | |||||||||||||||||||
General and administrative | 26,541 | 24,776 | 117,868 | 100,397 | |||||||||||||||||||
Restructuring costs | 1,472 | — | 2,320 | — | |||||||||||||||||||
Litigation expense | 96,300 | — | 96,300 | — | |||||||||||||||||||
Total operating expenses | 188,201 | 101,504 | 483,687 | 399,024 | |||||||||||||||||||
Loss from operations | (122,632) | (19,120) | (203,363) | (77,231) | |||||||||||||||||||
Other income (expense): | |||||||||||||||||||||||
Interest income, net | 3,159 | 1,870 | 11,867 | 3,762 | |||||||||||||||||||
Change in estimated fair value of common stock warrant liability | — | 18 | 10 | 107 | |||||||||||||||||||
Other income (expense), net | 1,541 | (924) | 1,343 | (2,872) | |||||||||||||||||||
Total other income |
4,700 | 964 | 13,220 | 997 | |||||||||||||||||||
Loss before income taxes | (117,932) | (18,156) | (190,143) | (76,234) | |||||||||||||||||||
Income tax expense | (165) | (173) | (141) | (379) | |||||||||||||||||||
Net loss | $ | (118,097) | $ | (18,329) | $ | (190,284) | $ | (76,613) | |||||||||||||||
Net loss per share: | |||||||||||||||||||||||
Basic | $ | (2.21) | $ | (0.34) | $ | (3.54) | $ | (1.44) | |||||||||||||||
Diluted | $ | (2.21) | $ | (0.34) | $ | (3.54) | $ | (1.44) | |||||||||||||||
Weighted-average shares used to compute net loss per share: |
|||||||||||||||||||||||
Basic | 53,388,830 | 53,524,637 | 53,764,705 | 53,321,625 | |||||||||||||||||||
Diluted | 53,388,830 | 53,524,637 | 53,764,705 | 53,321,625 |
As of December 31, | |||||||||||
2023 | 2022 | ||||||||||
Assets | |||||||||||
Current assets: | |||||||||||
Cash and cash equivalents | $ | 82,197 | $ | 89,921 | |||||||
Marketable securities | 153,221 | 203,168 | |||||||||
Accounts receivable | 51,061 | 66,312 | |||||||||
Inventory | 19,471 | 19,232 | |||||||||
Prepaid and other current assets | 7,763 | 9,216 | |||||||||
Total current assets | 313,713 | 387,849 | |||||||||
Property and equipment, net | 35,246 | 35,529 | |||||||||
Operating leases right-of-use assets | 29,891 | 34,689 | |||||||||
Intangible assets, net | 45,701 | 43,051 | |||||||||
Goodwill | 40,336 | 37,523 | |||||||||
Restricted cash | 586 | 522 | |||||||||
Other assets | 1,353 | 3,828 | |||||||||
Total assets | $ | 466,826 | $ | 542,991 | |||||||
Liabilities and stockholders’ equity | |||||||||||
Current liabilities: | |||||||||||
Accounts payable | $ | 12,872 | $ | 9,942 | |||||||
Accrued compensation | 19,703 | 16,902 | |||||||||
Accrued and other liabilities | 45,497 | 49,131 | |||||||||
Total current liabilities | 78,072 | 75,975 | |||||||||
Deferred tax liability | 136 | — | |||||||||
Common stock warrant liability | — | 32 | |||||||||
Deferred payments for intangible assets | 2,461 | 2,418 | |||||||||
Operating lease liability, less current portion | 28,278 | 33,406 | |||||||||
Other liabilities | 96,551 | 249 | |||||||||
Total liabilities | 205,498 | 112,080 | |||||||||
Commitments and contingencies | |||||||||||
Stockholders’ equity: | |||||||||||
Common stock |
49 | 52 | |||||||||
Additional paid-in capital | 946,511 | 898,806 | |||||||||
Accumulated other comprehensive loss | (6,963) | (7,503) | |||||||||
Accumulated deficit | (678,269) | (460,444) | |||||||||
Total stockholders’ equity | 261,328 | 430,911 | |||||||||
Total liabilities and stockholders’ equity | $ | 466,826 | $ | 542,991 |
Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
Cost of testing services reconciliation: | |||||||||||||||||||||||
GAAP cost of testing services | $ | 13,805 | $ | 18,657 | $ | 57,642 | $ | 72,286 | |||||||||||||||
Stock-based compensation expense | (387) | (474) | (1,854) | (1,529) | |||||||||||||||||||
Acquisition related-amortization of purchased intangibles | (329) | (329) | (1,316) | (1,316) | |||||||||||||||||||
Non-GAAP cost of testing services | $ | 13,089 | $ | 17,854 | $ | 54,472 | $ | 69,441 | |||||||||||||||
Cost of product reconciliation: | |||||||||||||||||||||||
GAAP cost of product | $ | 5,750 | $ | 4,617 | $ | 18,492 | $ | 17,639 | |||||||||||||||
Stock-based compensation expense | (230) | (269) | (1,165) | (1,120) | |||||||||||||||||||
Acquisition related-amortization of purchased intangibles | (413) | (411) | (1,655) | (1,716) | |||||||||||||||||||
Restructuring costs | (113) | — | (113) | — | |||||||||||||||||||
Non-GAAP cost of product | $ | 4,994 | $ | 3,937 | $ | 15,559 | $ | 14,803 | |||||||||||||||
Cost of patient and digital solutions reconciliation: | |||||||||||||||||||||||
GAAP cost of patient and digital solutions | $ | 6,226 | $ | 6,216 | $ | 26,047 | $ | 22,287 | |||||||||||||||
Stock-based compensation expense | (311) | (449) | (1,377) | (1,331) | |||||||||||||||||||
Acquisition related-amortization of purchased intangibles | (271) | (236) | (1,039) | (945) | |||||||||||||||||||
Restructuring costs | (55) | — | (69) | — | |||||||||||||||||||
Non-GAAP cost of patient and digital solutions | $ | 5,589 | $ | 5,531 | $ | 23,562 | $ | 20,011 | |||||||||||||||
Research and development expenses reconciliation: | |||||||||||||||||||||||
GAAP research and development expenses | $ | 18,617 | $ | 23,570 | $ | 82,452 | $ | 90,388 | |||||||||||||||
Stock-based compensation expense | (1,399) | (820) | (6,556) | (7,391) | |||||||||||||||||||
Asset impairments and write-downs | — | — | — | (340) | |||||||||||||||||||
Restructuring costs | (341) | — | (586) | — | |||||||||||||||||||
Non-GAAP research and development expenses | $ | 16,877 | $ | 22,750 | $ | 75,310 | $ | 82,657 | |||||||||||||||
Sales and marketing expenses reconciliation: | |||||||||||||||||||||||
GAAP sales and marketing expenses | $ | 20,254 | $ | 23,668 | $ | 84,137 | $ | 96,027 | |||||||||||||||
Stock-based compensation expense | (2,913) | (4,701) | (12,470) | (14,403) | |||||||||||||||||||
Acquisition related-amortization of purchased intangibles | (641) | (550) | (2,457) | (2,252) | |||||||||||||||||||
Restructuring costs | (255) | — | (803) | — | |||||||||||||||||||
Non-GAAP sales and marketing expenses | $ | 16,445 | $ | 18,417 | $ | 68,407 | $ | 79,372 | |||||||||||||||
General and administrative expenses reconciliation: | |||||||||||||||||||||||
GAAP general and administrative expenses | $ | 123,549 | $ | 24,776 | $ | 214,917 | $ | 100,397 | |||||||||||||||
Stock-based compensation expense | (4,720) | (5,413) | (25,664) | (20,779) | |||||||||||||||||||
Change in estimated fair value of contingent consideration | (946) | 103 | (2,677) | (727) | |||||||||||||||||||
Acquisition related fees and expenses | (51) | (212) | (589) | (599) | |||||||||||||||||||
Restructuring costs | (708) | — | (749) | — | |||||||||||||||||||
Litigation expense | (96,300) | — | (96,300) | — | |||||||||||||||||||
Other charges | — | — | (64) | — | |||||||||||||||||||
Non-GAAP general and administrative expenses | $ | 20,824 | $ | 19,254 | $ | 88,874 | $ | 78,292 | |||||||||||||||
Total other (expense) income reconciliation: | |||||||||||||||||||||||
GAAP other income (expense), net |
$ | 4,700 | $ | 964 | $ | 13,220 | $ | 997 | |||||||||||||||
Unrealized loss on investments | — | 965 | 1,190 | 1,181 | |||||||||||||||||||
Realized gain on investment | (1,468) | — | (1,468) | — | |||||||||||||||||||
Investment impairment | — | — | 1,000 | 500 | |||||||||||||||||||
Other charges (income) |
— | 11 | (2,081) | 43 | |||||||||||||||||||
Non-GAAP other income, net | $ | 3,232 | $ | 1,940 | $ | 11,861 | $ | 2,721 | |||||||||||||||
Income tax expense reconciliation: | |||||||||||||||||||||||
GAAP income tax expense | $ | (165) | $ | (173) | $ | (141) | $ | (379) | |||||||||||||||
Tax effect related to amortization of purchased intangibles | (99) | (98) | (398) | (419) | |||||||||||||||||||
Non-GAAP income tax expense | $ | (264) | $ | (271) | $ | (539) | $ | (798) |
Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
GAAP operating expenses: | |||||||||||||||||||||||
Research and development | $ | 18,617 | $ | 23,570 | $ | 82,452 | $ | 90,388 | |||||||||||||||
Sales and marketing | 20,254 | 23,668 | 84,137 | 96,027 | |||||||||||||||||||
General and administrative | 123,549 | 24,776 | 214,917 | 100,397 | |||||||||||||||||||
Total GAAP operating expenses | $ | 162,420 | $ | 72,014 | $ | 381,506 | $ | 286,812 | |||||||||||||||
Non-GAAP operating expenses: | |||||||||||||||||||||||
Research and development | $ | 16,877 | $ | 22,750 | $ | 75,310 | $ | 82,657 | |||||||||||||||
Sales and marketing | 16,445 | 18,417 | 68,407 | 79,372 | |||||||||||||||||||
General and administrative | 20,824 | 19,254 | 88,874 | 78,292 | |||||||||||||||||||
Total Non-GAAP operating expenses | $ | 54,146 | $ | 60,421 | $ | 232,591 | $ | 240,321 |
Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
Total revenue | $ | 65,569 | $ | 82,384 | $ | 280,324 | $ | 321,793 | |||||||||||||||
GAAP cost of sales | 25,781 | 29,490 | 102,181 | 112,212 | |||||||||||||||||||
GAAP gross profit | 39,788 | 52,894 | 178,143 | 209,581 | |||||||||||||||||||
Stock-based compensation expense | 928 | 1,192 | 4,396 | 3,980 | |||||||||||||||||||
Restructuring costs | 168 | — | 182 | — | |||||||||||||||||||
Acquisition related-amortization of purchased intangibles | 1,013 | 976 | 4,010 | 3,977 | |||||||||||||||||||
Non-GAAP gross profit | $ | 41,897 | $ | 55,062 | $ | 186,731 | $ | 217,538 | |||||||||||||||
Non-GAAP gross margin % | 64 | % | 67 | % | 67 | % | 68 | % |
Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
GAAP net loss | $ | (118,097) | $ | (18,329) | $ | (190,284) | $ | (76,613) | |||||||||||||||
Stock-based compensation expense | 9,960 | 12,126 | 49,086 | 46,553 | |||||||||||||||||||
Unrealized loss on investments | — | 965 | 1,190 | 1,181 | |||||||||||||||||||
Realized gain on investments | (1,468) | — | (1,468) | — | |||||||||||||||||||
Acquisition related-amortization of purchased intangibles | 1,654 | 1,526 | 6,467 | 6,229 | |||||||||||||||||||
Acquisition related fees and expenses | 51 | 212 | 589 | 599 | |||||||||||||||||||
Change in estimated fair value of contingent consideration | 946 | (103) | 2,677 | 727 | |||||||||||||||||||
Tax effect related to amortization of purchased intangibles | (99) | (98) | (398) | (419) | |||||||||||||||||||
Asset impairments and write-downs | — | — | 1,000 | 840 | |||||||||||||||||||
Litigation expense | 96,300 | — | 96,300 | — | |||||||||||||||||||
Restructuring costs | 1,472 | — | 2,320 | — | |||||||||||||||||||
Other charges | — | 11 | (2,017) | 43 | |||||||||||||||||||
Non-GAAP net loss | $ | (9,281) | $ | (3,690) | $ | (34,538) | $ | (20,860) | |||||||||||||||
GAAP basic and diluted net loss per share | $ | (2.21) | $ | (0.34) | $ | (3.54) | $ | (1.44) | |||||||||||||||
Non-GAAP basic net loss per share | $ | (0.17) | $ | (0.07) | $ | (0.64) | $ | (0.39) | |||||||||||||||
Non-GAAP diluted net loss per share | $ | (0.17) | $ | (0.07) | $ | (0.64) | $ | (0.39) | |||||||||||||||
Shares used in computing non-GAAP basic net loss per share |
53,388,830 | 53,524,637 | 53,764,705 | 53,321,625 | |||||||||||||||||||
Shares used in computing non-GAAP diluted net loss per share |
53,388,830 | 53,524,637 | 53,764,705 | 53,321,625 |
Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||||||||||
Non-GAAP net loss | $ | (9,281) | $ | (3,690) | $ | (34,538) | $ | (20,860) | |||||||||||||||
Interest income | (3,159) | (1,870) | (11,867) | (3,762) | |||||||||||||||||||
Income tax expense | 264 | 272 | 539 | 798 | |||||||||||||||||||
Depreciation expense | 1,978 | 1,682 | 7,882 | 5,248 | |||||||||||||||||||
Other (income) expense, net |
(72) | (70) | 7 | 1,041 | |||||||||||||||||||
Adjusted EBITDA | $ | (10,270) | $ | (3,676) | $ | (37,977) | $ | (17,535) |