CareDx Reports Third Quarter 2021 Results; Increases Full Year Revenue Guidance
10/28/2021 - 04:01 PM
SOUTH SAN FRANCISCO, Calif., Oct. 28, 2021 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq: CDNA), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today reported financial results for the third quarter ended September 30, 2021.
Recent Highlights:
Achieved record revenue of $75.6 million for the three months ended September 30, 2021, increasing 42% year-over-year Grew testing services volume 86% year-over-year, with approximately 40,000 AlloSure and AlloMap patient results provided in the quarter - highlighted by an approximately 90% attach rate for HeartCare Announced publication of KidneyCare validation study in Kidney360 – Multicenter study validating AlloMap and demonstrating the complementary value with AlloSure for detecting rejection Received first commercial AlloSure Lung coverage, followed by commercial launch of AlloSure Lung, the first dd-cfDNA test available for lung transplant patients, in October “I'm pleased with our strong performance in the third quarter, driven by 86% volume growth in testing services,” said Reg Seeto, President and Chief Executive Officer of CareDx. “We made significant progress toward our goal of OrganCare multi-modality, while continuing our pan-organ leadership in being the first with dd-cfDNA in Heart, Kidney and now Lung. We remain 100% committed to patients, and to transforming the transplant patient journey through innovation.”
Third Quarter 2021 Financial Results
Revenue for the three months ended September 30, 2021 was $75.6 million , an increase of 42% compared with $53.4 million in the third quarter of 2020. Testing services revenue for the third quarter was $66.5 million , compared with $45.5 million in the same period of 2020. Product revenue in the three months ended September 30, 2021 was $6.5 million , compared to $5.4 million in the same period of 2020. Digital and other revenue for the third quarter of 2021 was $2.6 million .
For the third quarter of 2021, net loss was $11.9 million compared to a net loss of $2.8 million in the same period of 2020. Basic and diluted net loss per share was $0.23 in the third quarter of 2021, compared to basic and diluted net loss per share of $0.06 in the third quarter of 2020.
Non-GAAP net income was $4.0 million in the third quarter of 2021 compared to a $5.1 million non-GAAP net income in the third quarter of 2020. Diluted non-GAAP net income per share was $0.07 in the third quarter of 2021, compared to a diluted non-GAAP net income per share of $0.10 in the third quarter of 2020.
Adjusted EBITDA for the third quarter of 2021 was a gain of $4.7 million , compared to an adjusted EBITDA of $5.6 million in the third quarter of 2020.
Cash, cash equivalents & marketable securities were $363.3 million as of September 30, 2021.
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” and “Reconciliation of GAAP to Non-GAAP Adjusted EBITDA Financial Measures” below.
2021 Guidance
For the full year 2021, CareDx now expects revenue to be in the range of $290 million to $293 million (previously $280 million to $290 million ).
About CareDx
CareDx, Inc., headquartered in South San Francisco, 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 the Company's fiscal 2021 revenue, achievement of our financial and operational goals and our prospects. 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, including general economic and market factors, among others discussed in CareDx’s filings with the SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed by CareDx with the SEC on February 24, 2021, and the periodic reports that CareDx has subsequently 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. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.
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 net income, non-GAAP basic and diluted net income per share and adjusted EBITDA. We define non-GAAP net income and per share results as the GAAP net income and per share results excluding the impacts of stock-based compensation; net unrealized gains and losses related to equity securities, changes in estimated fair value of warrants, derivative liabilities and contingent consideration; acquisition related impairment charges and amortization of intangible assets, purchase accounting adjustments and related tax effects; costs involved with completing an acquisition; amortization of debt discount; and certain other financing charges. We define adjusted EBITDA as non-GAAP net income/(loss) before net interest income/(expense), income tax benefit, depreciation and amortization, and other income and expense. 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.
Investor Relations Contact
Ian Cooneyinvestor@caredx.com
CareDx, Inc. Condensed Consolidated Statements of Operations (Unaudited) (In thousands, except share and per share data)
Three Months Ended Nine Months Ended 2021 2020 2021 2020 Revenue: Testing services revenue $ 66,464 $ 45,529 $ 190,635 $ 113,264 Product revenue 6,521 5,383 19,160 13,369 Digital and other revenue 2,604 2,457 7,382 6,917 Total revenue 75,589 53,369 217,177 133,550 Operating expenses: Cost of testing services 18,038 11,900 51,756 30,631 Cost of product 4,919 3,705 13,771 9,635 Cost of digital and other 1,879 1,210 4,861 3,966 Research and development 19,439 12,474 54,479 35,616 Sales and marketing 21,370 13,870 56,421 37,727 General and administrative 18,671 13,117 50,216 35,436 Total operating expenses 84,316 56,276 231,504 153,011 Loss from operations (8,727 ) (2,907 ) (14,327 ) (19,461 ) Other income (expense): Interest income, net 20 29 147 146 Change in estimated fair value of common stock warrant liability 88 79 50 (990 ) CARES Act Provider Relief Fund — — — 4,813 Other expense, net (3,440 ) (254 ) (906 ) (572 ) Total other (expense) income (3,332 ) (146 ) (709 ) 3,397 Loss before income taxes (12,059 ) (3,053 ) (15,036 ) (16,064 ) Income tax benefit 162 235 525 865 Net loss $ (11,897 ) $ (2,818 ) $ (14,511 ) $ (15,199 ) Net loss per share: Basic $ (0.23 ) $ (0.06 ) $ (0.28 ) $ (0.33 ) Diluted $ (0.23 ) $ (0.06 ) $ (0.28 ) $ (0.33 ) Weighted-average shares used to compute net loss per share: Basic 52,681,451 49,010,680 52,034,450 45,526,810 Diluted 52,681,451 49,010,680 52,034,450 45,526,810
CareDx, Inc. Condensed Consolidated Balance Sheets (Unaudited) (In thousands)
September 30, December 31, Assets Current assets: Cash and cash equivalents $ 353,082 $ 134,669 Marketable securities 10,199 90,034 Accounts receivable 56,181 34,624 Inventory 18,800 10,012 Prepaid and other current assets 6,413 3,758 Total current assets 444,675 273,097 Property and equipment, net 18,719 10,704 Operating leases right-of-use assets 18,316 15,228 Intangible assets, net 48,367 44,355 Goodwill 26,051 23,857 Restricted cash 210 270 Other assets 6,834 1,000 Total assets $ 563,172 $ 368,511 Liabilities and stockholders’ equity Current liabilities: Accounts payable $ 14,894 $ 9,653 Accrued compensation 24,243 18,466 Accrued and other liabilities 30,599 20,602 Refund liability - CMS advance payment — 20,496 Total current liabilities 69,736 69,217 Deferred tax liability 678 1,299 Common stock warrant liability 195 447 Deferred payments for intangible assets 2,084 3,560 Operating lease liability, less current portion 17,876 16,069 Other liabilities 456 240 Total liabilities 91,025 90,832 Commitments and contingencies Stockholders’ equity: Common stock 52 49 Additional paid-in capital 843,226 632,253 Accumulated other comprehensive loss (4,093 ) (2,096 ) Accumulated deficit (367,038 ) (352,527 ) Total stockholders’ equity 472,147 277,679 Total liabilities and stockholders’ equity $ 563,172 $ 368,511
CareDx, Inc. Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) (In thousands)
Three Months Ended Nine Months Ended 2021 2020 2021 2020 Cost of testing services reconciliation: GAAP cost of testing services $ 18,038 $ 11,900 $ 51,756 $ 30,631 Stock-based compensation expense (750 ) (431 ) (1,715 ) (1,101 ) Acquisition related-amortization of purchased intangibles (329 ) (329 ) (987 ) (987 ) Non-GAAP cost of testing services $ 16,959 $ 11,140 $ 49,054 $ 28,543 Cost of product reconciliation: GAAP cost of product $ 4,919 $ 3,705 $ 13,771 $ 9,635 Stock-based compensation expense (156 ) (97 ) (446 ) (289 ) Acquisition related-amortization of purchased intangibles (480 ) (445 ) (1,434 ) (1,210 ) Non-GAAP cost of product $ 4,283 $ 3,163 $ 11,891 $ 8,136 Cost of digital and other reconciliation: GAAP cost of digital and other $ 1,879 $ 1,210 $ 4,861 $ 3,966 Stock-based compensation expense (217 ) (124 ) (555 ) (338 ) Acquisition related-amortization of purchased intangibles (209 ) (86 ) (458 ) (259 ) Non-GAAP cost of digital and other $ 1,453 $ 1,000 $ 3,848 $ 3,369 Research and development expenses reconciliation: GAAP research and development expenses $ 19,439 $ 12,474 $ 54,479 $ 35,616 Stock-based compensation expense (1,986 ) (1,224 ) (5,284 ) (3,490 ) Non-GAAP research and development expenses $ 17,453 $ 11,250 $ 49,195 $ 32,126 Sales and marketing expenses reconciliation: GAAP sales and marketing expenses $ 21,370 $ 13,870 $ 56,421 $ 37,727 Stock-based compensation expense (3,853 ) (1,623 ) (8,144 ) (4,175 ) Acquisition related-amortization of purchased intangibles (502 ) (376 ) (1,344 ) (1,089 ) Non-GAAP sales and marketing expenses $ 17,015 $ 11,871 $ 46,933 $ 32,463 General and administrative expenses reconciliation: GAAP general and administrative expenses $ 18,671 $ 13,117 $ 50,216 $ 35,436 Stock-based compensation expense (3,677 ) (3,249 ) (10,439 ) (8,031 ) Change in estimated fair value of contingent consideration (156 ) (35 ) 35 (301 ) Acquisition related fees and expenses (485 ) — (866 ) — Non-GAAP general and administrative expenses $ 14,353 $ 9,833 $ 38,946 $ 27,104 Total other income (expense) reconciliation: GAAP other income (expense), net $ (3,332 ) $ (146 ) $ (709 ) $ 3,397 Unrealized loss on long-term marketable equity securities 3,257 — 167 — Change in estimated fair value of common stock warrant liability (88 ) (79 ) (50 ) 990 Accretion of liability 55 80 199 272 Non-GAAP other (expense) income, net $ (108 ) $ (145 ) $ (393 ) $ 4,659 Income tax benefit reconciliation: GAAP income tax benefit $ 162 $ 235 $ 525 $ 865 Tax effect related to amortization of purchased intangibles (122 ) (130 ) (373 ) (369 ) Non-GAAP income tax benefit $ 40 $ 105 $ 152 $ 496
CareDx, Inc. Reconciliation of GAAP to Non-GAAP Financial Measures (Unaudited) (In thousands, except share and per share data)
Three Months Ended Nine Months Ended 2021 2020 2021 2020 Net loss $ (11,897 ) $ (2,818 ) $ (14,511 ) $ (15,199 ) Stock-based compensation expense 10,639 6,748 26,583 17,424 Unrealized loss on long-term marketable equity securities 3,257 — 167 — Acquisition related-amortization of purchased intangibles 1,520 1,236 4,223 3,545 Acquisition related fees and expenses 485 — 866 — Change in estimated fair value of contingent consideration 156 35 (35 ) 301 Change in estimated fair value of common stock warrant liability (88 ) (79 ) (50 ) 990 Accretion of liability 55 80 199 272 Tax effect related to amortization of purchased intangibles (122 ) (130 ) (373 ) (369 ) Non-GAAP net income $ 4,005 $ 5,072 $ 17,069 $ 6,964 GAAP basic and diluted net loss per share $ (0.23 ) $ (0.06 ) $ (0.28 ) $ (0.33 ) Non-GAAP basic net income per share $ 0.08 $ 0.10 $ 0.33 $ 0.15 Non-GAAP diluted net income per share $ 0.07 $ 0.10 $ 0.31 $ 0.15 Shares used in computing non-GAAP basic net income per share 52,681,451 49,010,680 52,034,450 45,526,810 Shares used in computing non-GAAP diluted net income per share 54,584,822 50,446,939 54,454,433 46,571,527
CareDx, Inc. Reconciliation of Non-GAAP to Adjusted EBITDA Financial Measures (Unaudited) (In thousands)
Three Months Ended Nine Months Ended 2021 2020 2021 2020 Non-GAAP net income $ 4,005 $ 5,072 $ 17,069 $ 6,964 Interest income (20 ) (29 ) (147 ) (146 ) Income tax benefit (40 ) (105 ) (152 ) (496 ) Depreciation expense 624 486 1,879 1,235 CARES Act Provider Relief Fund — — — (4,813 ) Other expense, net 128 174 540 300 Adjusted EBITDA $ 4,697 $ 5,598 $ 19,189 $ 3,044
