Recent Quotes View Full List My Watchlist Create Watchlist Indicators DJI Nasdaq Composite SPX Gold Crude Oil EL&P Market Index Markets Stocks ETFs Tools Overview News Currencies International Treasuries CareDx Announces Fourth Quarter and Full Year 2023 Financial Results By: CareDx, Inc. via Business Wire February 28, 2024 at 16:05 PM EST Delivered Total Revenue of $280.3 Million, Exceeding the High End of Updated Guidance for 2023 Grew Testing Services Results for the Second Quarter in a Row CareDx, Inc. (Nasdaq: CDNA) today reported financial results for the fourth quarter and full year ended December 31, 2023. Fourth Quarter and Full Year 2023 Highlights Reported full year revenue of $280.3 million, exceeding the high end of updated guidance for 2023. Reported full year Testing Services revenue of $209.7 million and delivered approximately 165,700 patient results in 2023. Grew Testing Services patient results for the second quarter in a row to approximately 39,900, an increase of 4% as compared to the third quarter of 2023. Reported full year revenue of $37.1 million for Patient and Digital Solutions and $33.5 million for Product, representing year-over-year growth of 29% and 15%, respectively. Ended 2023 with cash and cash equivalents, and marketable securities of approximately $235.4 million, with no debt. Achieved the fifth consecutive quarter of collections at over 100% of Testing Services revenue driven by revenue cycle management initiatives. Collected $17 million in cash over its revenue in 2023. Repurchased 2.9 million shares of common stock for $27.5 million under share buyback program in 2023. Received Medicare coverage for HeartCare and AlloSure Lung. CareDx is in the process of seeking judicial review of January 2024 jury decision and monetary damages related to alleged infringement of patent ‘544. “In 2023, we met our challenges head-on as we navigated the impact of Medicare coverage changes. We reset our operations, strategically reduced our cost structure, and created a growth pathway for the company in the second half of the year, as we continued to focus on care for transplant patients,” said Alex Johnson, President of Patient and Testing Services, and a member of the Office of the CEO at CareDx. “Looking forward to 2024, we are focused on delivering high-value clinical and digital solutions to improve allograft survival, while generating evidence for expanding payer coverage and accelerating our path back to profitability.” Q4 2023 Financial Results Revenue for the three months ended December 31, 2023, was $65.6 million, a decrease of 20% compared with $82.4 million for the fourth quarter of 2022. Testing Services revenue for the fourth quarter 2023 was $46.7 million, a decrease of 29% compared with $65.4 million in the same period in 2022. Testing Services revenue was negatively impacted due to the Medicare Billing Article changes. Total AlloSure and AlloMap patient results provided in the fourth quarter 2023 were approximately 39,900, a decrease of 16% as compared to the same quarter a year ago, and an increase of 4% compared to the third quarter of 2023. Patient and Digital Solutions revenue for the fourth quarter 2023 was $9.6 million, compared to $8.4 million in the same period in 2022, an increase of 14%. Product revenue for the fourth quarter 2023 was $9.2 million, compared to $8.6 million in the same period in 2022, an increase of 8%. For the fourth quarter of 2023, net loss was $118.1 million, including $96.3 million accrual associated with damages related to alleged infringement of patent ‘544, compared to a net loss of $18.3 million in the fourth quarter of 2022. Basic and diluted net loss per share in the fourth quarter of 2023 was $2.21, compared to basic and diluted net loss per share of $0.34 in the fourth quarter of 2022. Non-GAAP net loss was $9.3 million in the fourth quarter of 2023, compared to a non-GAAP net loss of $3.7 million in the fourth quarter of 2022. Basic and diluted non-GAAP net loss per share was $0.17 in the fourth quarter of 2023, compared to a basic and diluted non-GAAP net loss per share of $0.07 in the fourth quarter of 2022. Adjusted EBITDA for the fourth quarter of 2023 was a loss of $10.3 million, compared to an adjusted EBITDA loss of $3.7 million in the fourth quarter of 2022. Full Year 2023 Financial Results Total revenue for the full year ended December 31, 2023, was $280.3 million, a decrease of 13% compared with $321.8 million in 2022. Testing Services revenue for the full year 2023 was $209.7 million, compared with $263.7 million in 2022, a decrease of 20%. Patient and Digital Solutions revenue for the full year 2023 was $37.1 million, compared to $28.8 million in 2022, an increase of 29%. Product revenue for the full year 2023 was $33.5 million, compared to $29.3 million in 2022, an increase of 15%. Net loss for the full year 2023 was $190.3 million, including $96.3 million accrual associated with damages related to alleged infringement of patent ‘544, compared to a net loss of $76.6 million in 2022. Basic and diluted net loss per share for the full year 2023 was $3.54, compared to basic and diluted net loss per share of $1.44 in the full year 2022. Non-GAAP net loss was $34.5 million for the full year 2023, compared to a non-GAAP net loss of $20.9 million for the full year ended 2022. Basic and diluted non-GAAP net loss per share was $0.64 in the full year of 2023, compared to a basic and diluted non-GAAP net loss per share of $0.39 in the full year of 2022. Adjusted EBITDA for the full year of 2023 was a loss of $38.0 million, compared to an adjusted EBITDA loss of $17.5 million for the full year of 2022. Cash and cash equivalents and marketable securities were $235.4 million as of December 31, 2023. Reduced cash used in operations from $25.2 million in 2022 to $18.4 million in 2023. For additional information regarding non-GAAP financial measures discussed herein, please see “Use of Non-GAAP Financial Measures,” “Reconciliation of GAAP to Non-GAAP Financial Measures,” “Reconciliation of GAAP to Non-GAAP Gross Profit and Gross Margin,” and “Reconciliation of Non-GAAP to Adjusted EBITDA Financial Measures” below. 2024 Guidance For the full year 2024, CareDx expects revenue to be in the range of $260 million to $274 million. About CareDx – The Transplant Company CareDx, Inc., headquartered in Brisbane, California, is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients. For more information, please visit: www.CareDx.com. Forward-Looking Statements This press release includes forward-looking statements, including expectations regarding CareDx’s 2024 revenue, CareDx’s plans to seek judicial review of jury decision and historical monetary damages on patent ‘544, CareDx’s focus in 2024 and CareDx’s proposed path to profitability. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, all of which are difficult to predict and many of which are beyond our control, including general economic and market factors, and global economic and marketplace uncertainties related to the COVID-19 pandemic, among others discussed in CareDx’s filings with the Securities and Exchange Commission (the “SEC”), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed by CareDx with the SEC on February 28, 2024, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. Use of Non-GAAP Financial Measures CareDx has presented in this release certain financial information in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and also on a non-GAAP basis, including non-GAAP cost of testing services, non-GAAP cost of product, non-GAAP cost of patient and digital solutions, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses, non-GAAP other income, net, non-GAAP income tax expense, non-GAAP gross profit, non-GAAP gross margin (%), non-GAAP net loss, non-GAAP basic and diluted net loss per share, adjusted EBITDA, and non-GAAP operating expenses. We define non-GAAP net loss and per share results as the GAAP net loss and per share results excluding the impacts of stock-based compensation; changes in estimated fair value of contingent consideration; acquisition-related impairment charges and amortization of purchased intangible assets and related tax effects; costs involved with completing an acquisition; unrealized loss on investments; realized gain on investments; restructuring charges and certain other charges. We define adjusted EBITDA as non-GAAP net loss before net interest income, income tax expense, depreciation and other (income) expense, net. We are presenting these non-GAAP financial measures to assist investors in assessing our operating results through the eyes of management and because we believe that these measures provide an additional tool for investors to use in comparing our core business operating results over multiple periods. Management believes this non-GAAP information is useful for investors, when considered in conjunction with CareDx’s GAAP financial statements, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of CareDx’s operating results as reported under GAAP. These non-GAAP financial measures should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with GAAP. These non-GAAP financial measures are not necessarily comparable to similarly titled measures presented by other companies. A reconciliation between GAAP and non-GAAP financial information is provided immediately following the financial tables. CareDx, Inc. Consolidated Statements of Operations (Unaudited) (In thousands, except share and per share data) 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 CareDx, Inc. Consolidated Balance Sheets (In thousands) 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 CareDx, Inc. Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) (In thousands) 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 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 ) CareDx, Inc. GAAP and Non-GAAP Operating Expenses (Unaudited) (In thousands) 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 CareDx, Inc. Reconciliation of GAAP to Non-GAAP Gross Profit and Gross Margin (Unaudited) (In thousands, except percentages) 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 % CareDx, Inc. Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) (In thousands, except share and per share data) 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 CareDx, Inc. Reconciliation of Non-GAAP to Adjusted EBITDA Financial Measures (Unaudited) (In thousands) 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 ) View source version on businesswire.com: https://www.businesswire.com/news/home/20240228248706/en/Contacts CareDx, Inc. Media Relations Anna Czene 818-731-2203 aczene@caredx.com Investor Relations Greg Chodaczek investor@CareDx.com Data & News supplied by www.cloudquote.io Stock quotes supplied by Barchart Quotes delayed at least 20 minutes. By accessing this page, you agree to the following Privacy Policy and Terms and Conditions.
CareDx Announces Fourth Quarter and Full Year 2023 Financial Results By: CareDx, Inc. via Business Wire February 28, 2024 at 16:05 PM EST Delivered Total Revenue of $280.3 Million, Exceeding the High End of Updated Guidance for 2023 Grew Testing Services Results for the Second Quarter in a Row CareDx, Inc. (Nasdaq: CDNA) today reported financial results for the fourth quarter and full year ended December 31, 2023. Fourth Quarter and Full Year 2023 Highlights Reported full year revenue of $280.3 million, exceeding the high end of updated guidance for 2023. Reported full year Testing Services revenue of $209.7 million and delivered approximately 165,700 patient results in 2023. Grew Testing Services patient results for the second quarter in a row to approximately 39,900, an increase of 4% as compared to the third quarter of 2023. Reported full year revenue of $37.1 million for Patient and Digital Solutions and $33.5 million for Product, representing year-over-year growth of 29% and 15%, respectively. Ended 2023 with cash and cash equivalents, and marketable securities of approximately $235.4 million, with no debt. Achieved the fifth consecutive quarter of collections at over 100% of Testing Services revenue driven by revenue cycle management initiatives. Collected $17 million in cash over its revenue in 2023. Repurchased 2.9 million shares of common stock for $27.5 million under share buyback program in 2023. Received Medicare coverage for HeartCare and AlloSure Lung. CareDx is in the process of seeking judicial review of January 2024 jury decision and monetary damages related to alleged infringement of patent ‘544. “In 2023, we met our challenges head-on as we navigated the impact of Medicare coverage changes. We reset our operations, strategically reduced our cost structure, and created a growth pathway for the company in the second half of the year, as we continued to focus on care for transplant patients,” said Alex Johnson, President of Patient and Testing Services, and a member of the Office of the CEO at CareDx. “Looking forward to 2024, we are focused on delivering high-value clinical and digital solutions to improve allograft survival, while generating evidence for expanding payer coverage and accelerating our path back to profitability.” Q4 2023 Financial Results Revenue for the three months ended December 31, 2023, was $65.6 million, a decrease of 20% compared with $82.4 million for the fourth quarter of 2022. Testing Services revenue for the fourth quarter 2023 was $46.7 million, a decrease of 29% compared with $65.4 million in the same period in 2022. Testing Services revenue was negatively impacted due to the Medicare Billing Article changes. Total AlloSure and AlloMap patient results provided in the fourth quarter 2023 were approximately 39,900, a decrease of 16% as compared to the same quarter a year ago, and an increase of 4% compared to the third quarter of 2023. Patient and Digital Solutions revenue for the fourth quarter 2023 was $9.6 million, compared to $8.4 million in the same period in 2022, an increase of 14%. Product revenue for the fourth quarter 2023 was $9.2 million, compared to $8.6 million in the same period in 2022, an increase of 8%. For the fourth quarter of 2023, net loss was $118.1 million, including $96.3 million accrual associated with damages related to alleged infringement of patent ‘544, compared to a net loss of $18.3 million in the fourth quarter of 2022. Basic and diluted net loss per share in the fourth quarter of 2023 was $2.21, compared to basic and diluted net loss per share of $0.34 in the fourth quarter of 2022. Non-GAAP net loss was $9.3 million in the fourth quarter of 2023, compared to a non-GAAP net loss of $3.7 million in the fourth quarter of 2022. Basic and diluted non-GAAP net loss per share was $0.17 in the fourth quarter of 2023, compared to a basic and diluted non-GAAP net loss per share of $0.07 in the fourth quarter of 2022. Adjusted EBITDA for the fourth quarter of 2023 was a loss of $10.3 million, compared to an adjusted EBITDA loss of $3.7 million in the fourth quarter of 2022. Full Year 2023 Financial Results Total revenue for the full year ended December 31, 2023, was $280.3 million, a decrease of 13% compared with $321.8 million in 2022. Testing Services revenue for the full year 2023 was $209.7 million, compared with $263.7 million in 2022, a decrease of 20%. Patient and Digital Solutions revenue for the full year 2023 was $37.1 million, compared to $28.8 million in 2022, an increase of 29%. Product revenue for the full year 2023 was $33.5 million, compared to $29.3 million in 2022, an increase of 15%. Net loss for the full year 2023 was $190.3 million, including $96.3 million accrual associated with damages related to alleged infringement of patent ‘544, compared to a net loss of $76.6 million in 2022. Basic and diluted net loss per share for the full year 2023 was $3.54, compared to basic and diluted net loss per share of $1.44 in the full year 2022. Non-GAAP net loss was $34.5 million for the full year 2023, compared to a non-GAAP net loss of $20.9 million for the full year ended 2022. Basic and diluted non-GAAP net loss per share was $0.64 in the full year of 2023, compared to a basic and diluted non-GAAP net loss per share of $0.39 in the full year of 2022. Adjusted EBITDA for the full year of 2023 was a loss of $38.0 million, compared to an adjusted EBITDA loss of $17.5 million for the full year of 2022. Cash and cash equivalents and marketable securities were $235.4 million as of December 31, 2023. Reduced cash used in operations from $25.2 million in 2022 to $18.4 million in 2023. For additional information regarding non-GAAP financial measures discussed herein, please see “Use of Non-GAAP Financial Measures,” “Reconciliation of GAAP to Non-GAAP Financial Measures,” “Reconciliation of GAAP to Non-GAAP Gross Profit and Gross Margin,” and “Reconciliation of Non-GAAP to Adjusted EBITDA Financial Measures” below. 2024 Guidance For the full year 2024, CareDx expects revenue to be in the range of $260 million to $274 million. About CareDx – The Transplant Company CareDx, Inc., headquartered in Brisbane, California, is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients. For more information, please visit: www.CareDx.com. Forward-Looking Statements This press release includes forward-looking statements, including expectations regarding CareDx’s 2024 revenue, CareDx’s plans to seek judicial review of jury decision and historical monetary damages on patent ‘544, CareDx’s focus in 2024 and CareDx’s proposed path to profitability. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, all of which are difficult to predict and many of which are beyond our control, including general economic and market factors, and global economic and marketplace uncertainties related to the COVID-19 pandemic, among others discussed in CareDx’s filings with the Securities and Exchange Commission (the “SEC”), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed by CareDx with the SEC on February 28, 2024, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. Use of Non-GAAP Financial Measures CareDx has presented in this release certain financial information in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and also on a non-GAAP basis, including non-GAAP cost of testing services, non-GAAP cost of product, non-GAAP cost of patient and digital solutions, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses, non-GAAP other income, net, non-GAAP income tax expense, non-GAAP gross profit, non-GAAP gross margin (%), non-GAAP net loss, non-GAAP basic and diluted net loss per share, adjusted EBITDA, and non-GAAP operating expenses. We define non-GAAP net loss and per share results as the GAAP net loss and per share results excluding the impacts of stock-based compensation; changes in estimated fair value of contingent consideration; acquisition-related impairment charges and amortization of purchased intangible assets and related tax effects; costs involved with completing an acquisition; unrealized loss on investments; realized gain on investments; restructuring charges and certain other charges. We define adjusted EBITDA as non-GAAP net loss before net interest income, income tax expense, depreciation and other (income) expense, net. We are presenting these non-GAAP financial measures to assist investors in assessing our operating results through the eyes of management and because we believe that these measures provide an additional tool for investors to use in comparing our core business operating results over multiple periods. Management believes this non-GAAP information is useful for investors, when considered in conjunction with CareDx’s GAAP financial statements, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of CareDx’s operating results as reported under GAAP. These non-GAAP financial measures should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with GAAP. These non-GAAP financial measures are not necessarily comparable to similarly titled measures presented by other companies. A reconciliation between GAAP and non-GAAP financial information is provided immediately following the financial tables. CareDx, Inc. Consolidated Statements of Operations (Unaudited) (In thousands, except share and per share data) 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 CareDx, Inc. Consolidated Balance Sheets (In thousands) 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 CareDx, Inc. Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) (In thousands) 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 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 ) CareDx, Inc. GAAP and Non-GAAP Operating Expenses (Unaudited) (In thousands) 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 CareDx, Inc. Reconciliation of GAAP to Non-GAAP Gross Profit and Gross Margin (Unaudited) (In thousands, except percentages) 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 % CareDx, Inc. Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) (In thousands, except share and per share data) 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 CareDx, Inc. Reconciliation of Non-GAAP to Adjusted EBITDA Financial Measures (Unaudited) (In thousands) 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 ) View source version on businesswire.com: https://www.businesswire.com/news/home/20240228248706/en/Contacts CareDx, Inc. Media Relations Anna Czene 818-731-2203 aczene@caredx.com Investor Relations Greg Chodaczek investor@CareDx.com
Delivered Total Revenue of $280.3 Million, Exceeding the High End of Updated Guidance for 2023 Grew Testing Services Results for the Second Quarter in a Row
CareDx, Inc. (Nasdaq: CDNA) today reported financial results for the fourth quarter and full year ended December 31, 2023. Fourth Quarter and Full Year 2023 Highlights Reported full year revenue of $280.3 million, exceeding the high end of updated guidance for 2023. Reported full year Testing Services revenue of $209.7 million and delivered approximately 165,700 patient results in 2023. Grew Testing Services patient results for the second quarter in a row to approximately 39,900, an increase of 4% as compared to the third quarter of 2023. Reported full year revenue of $37.1 million for Patient and Digital Solutions and $33.5 million for Product, representing year-over-year growth of 29% and 15%, respectively. Ended 2023 with cash and cash equivalents, and marketable securities of approximately $235.4 million, with no debt. Achieved the fifth consecutive quarter of collections at over 100% of Testing Services revenue driven by revenue cycle management initiatives. Collected $17 million in cash over its revenue in 2023. Repurchased 2.9 million shares of common stock for $27.5 million under share buyback program in 2023. Received Medicare coverage for HeartCare and AlloSure Lung. CareDx is in the process of seeking judicial review of January 2024 jury decision and monetary damages related to alleged infringement of patent ‘544. “In 2023, we met our challenges head-on as we navigated the impact of Medicare coverage changes. We reset our operations, strategically reduced our cost structure, and created a growth pathway for the company in the second half of the year, as we continued to focus on care for transplant patients,” said Alex Johnson, President of Patient and Testing Services, and a member of the Office of the CEO at CareDx. “Looking forward to 2024, we are focused on delivering high-value clinical and digital solutions to improve allograft survival, while generating evidence for expanding payer coverage and accelerating our path back to profitability.” Q4 2023 Financial Results Revenue for the three months ended December 31, 2023, was $65.6 million, a decrease of 20% compared with $82.4 million for the fourth quarter of 2022. Testing Services revenue for the fourth quarter 2023 was $46.7 million, a decrease of 29% compared with $65.4 million in the same period in 2022. Testing Services revenue was negatively impacted due to the Medicare Billing Article changes. Total AlloSure and AlloMap patient results provided in the fourth quarter 2023 were approximately 39,900, a decrease of 16% as compared to the same quarter a year ago, and an increase of 4% compared to the third quarter of 2023. Patient and Digital Solutions revenue for the fourth quarter 2023 was $9.6 million, compared to $8.4 million in the same period in 2022, an increase of 14%. Product revenue for the fourth quarter 2023 was $9.2 million, compared to $8.6 million in the same period in 2022, an increase of 8%. For the fourth quarter of 2023, net loss was $118.1 million, including $96.3 million accrual associated with damages related to alleged infringement of patent ‘544, compared to a net loss of $18.3 million in the fourth quarter of 2022. Basic and diluted net loss per share in the fourth quarter of 2023 was $2.21, compared to basic and diluted net loss per share of $0.34 in the fourth quarter of 2022. Non-GAAP net loss was $9.3 million in the fourth quarter of 2023, compared to a non-GAAP net loss of $3.7 million in the fourth quarter of 2022. Basic and diluted non-GAAP net loss per share was $0.17 in the fourth quarter of 2023, compared to a basic and diluted non-GAAP net loss per share of $0.07 in the fourth quarter of 2022. Adjusted EBITDA for the fourth quarter of 2023 was a loss of $10.3 million, compared to an adjusted EBITDA loss of $3.7 million in the fourth quarter of 2022. Full Year 2023 Financial Results Total revenue for the full year ended December 31, 2023, was $280.3 million, a decrease of 13% compared with $321.8 million in 2022. Testing Services revenue for the full year 2023 was $209.7 million, compared with $263.7 million in 2022, a decrease of 20%. Patient and Digital Solutions revenue for the full year 2023 was $37.1 million, compared to $28.8 million in 2022, an increase of 29%. Product revenue for the full year 2023 was $33.5 million, compared to $29.3 million in 2022, an increase of 15%. Net loss for the full year 2023 was $190.3 million, including $96.3 million accrual associated with damages related to alleged infringement of patent ‘544, compared to a net loss of $76.6 million in 2022. Basic and diluted net loss per share for the full year 2023 was $3.54, compared to basic and diluted net loss per share of $1.44 in the full year 2022. Non-GAAP net loss was $34.5 million for the full year 2023, compared to a non-GAAP net loss of $20.9 million for the full year ended 2022. Basic and diluted non-GAAP net loss per share was $0.64 in the full year of 2023, compared to a basic and diluted non-GAAP net loss per share of $0.39 in the full year of 2022. Adjusted EBITDA for the full year of 2023 was a loss of $38.0 million, compared to an adjusted EBITDA loss of $17.5 million for the full year of 2022. Cash and cash equivalents and marketable securities were $235.4 million as of December 31, 2023. Reduced cash used in operations from $25.2 million in 2022 to $18.4 million in 2023. For additional information regarding non-GAAP financial measures discussed herein, please see “Use of Non-GAAP Financial Measures,” “Reconciliation of GAAP to Non-GAAP Financial Measures,” “Reconciliation of GAAP to Non-GAAP Gross Profit and Gross Margin,” and “Reconciliation of Non-GAAP to Adjusted EBITDA Financial Measures” below. 2024 Guidance For the full year 2024, CareDx expects revenue to be in the range of $260 million to $274 million. About CareDx – The Transplant Company CareDx, Inc., headquartered in Brisbane, California, is a leading precision medicine solutions company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients. For more information, please visit: www.CareDx.com. Forward-Looking Statements This press release includes forward-looking statements, including expectations regarding CareDx’s 2024 revenue, CareDx’s plans to seek judicial review of jury decision and historical monetary damages on patent ‘544, CareDx’s focus in 2024 and CareDx’s proposed path to profitability. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, all of which are difficult to predict and many of which are beyond our control, including general economic and market factors, and global economic and marketplace uncertainties related to the COVID-19 pandemic, among others discussed in CareDx’s filings with the Securities and Exchange Commission (the “SEC”), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed by CareDx with the SEC on February 28, 2024, and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. Use of Non-GAAP Financial Measures CareDx has presented in this release certain financial information in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and also on a non-GAAP basis, including non-GAAP cost of testing services, non-GAAP cost of product, non-GAAP cost of patient and digital solutions, non-GAAP research and development expenses, non-GAAP sales and marketing expenses, non-GAAP general and administrative expenses, non-GAAP other income, net, non-GAAP income tax expense, non-GAAP gross profit, non-GAAP gross margin (%), non-GAAP net loss, non-GAAP basic and diluted net loss per share, adjusted EBITDA, and non-GAAP operating expenses. We define non-GAAP net loss and per share results as the GAAP net loss and per share results excluding the impacts of stock-based compensation; changes in estimated fair value of contingent consideration; acquisition-related impairment charges and amortization of purchased intangible assets and related tax effects; costs involved with completing an acquisition; unrealized loss on investments; realized gain on investments; restructuring charges and certain other charges. We define adjusted EBITDA as non-GAAP net loss before net interest income, income tax expense, depreciation and other (income) expense, net. We are presenting these non-GAAP financial measures to assist investors in assessing our operating results through the eyes of management and because we believe that these measures provide an additional tool for investors to use in comparing our core business operating results over multiple periods. Management believes this non-GAAP information is useful for investors, when considered in conjunction with CareDx’s GAAP financial statements, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of CareDx’s operating results as reported under GAAP. These non-GAAP financial measures should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with GAAP. These non-GAAP financial measures are not necessarily comparable to similarly titled measures presented by other companies. A reconciliation between GAAP and non-GAAP financial information is provided immediately following the financial tables. CareDx, Inc. Consolidated Statements of Operations (Unaudited) (In thousands, except share and per share data) 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 CareDx, Inc. Consolidated Balance Sheets (In thousands) 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 CareDx, Inc. Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) (In thousands) 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 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 ) CareDx, Inc. GAAP and Non-GAAP Operating Expenses (Unaudited) (In thousands) 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 CareDx, Inc. Reconciliation of GAAP to Non-GAAP Gross Profit and Gross Margin (Unaudited) (In thousands, except percentages) 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 % CareDx, Inc. Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) (In thousands, except share and per share data) 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 CareDx, Inc. Reconciliation of Non-GAAP to Adjusted EBITDA Financial Measures (Unaudited) (In thousands) 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 ) View source version on businesswire.com: https://www.businesswire.com/news/home/20240228248706/en/
CareDx, Inc. Media Relations Anna Czene 818-731-2203 aczene@caredx.com Investor Relations Greg Chodaczek investor@CareDx.com