SOUTH SAN FRANCISCO, Calif., May 05, 2022 (GLOBE NEWSWIRE) -- CareDx, Inc. (Nasdaq: CDNA) — The Transplant 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 first quarter ended March 31, 2022.

Recent Highlights:

  • Achieved total revenue of $79.4 million for the three months ended March 31, 2022, increasing 18% year-over-year
  • Provided approximately 42,600 AlloSure and AlloMap patient results in the quarter, with March being our highest ever month of testing volume for Heart and Kidney Testing Services
  • Showcased scientific leadership with over 25 oral presentations and abstracts at the International Society of Heart and Lung Transplantation including real-world, multi-center, prospective, long-term SHORE data
  • Incorporated Tx Access into the AlloCare app to help pre-transplant patients navigate the waitlist process as we digitally connect patients across the patient journey
  • Helped ensure that the transplant community receives accurate information about our tests after a jury found that Natera made false superiority claims in its advertising, and awarded CareDx monetary damages totaling $44.9M
  • Announced the availability of XenoSure™ and XenoMap™, the world’s first surveillance solutions for investigational use in xenotransplantation research and post-xenotransplant clinical monitoring

“Our business saw strong momentum coming out of the quarter with March being our highest ever month in Testing Services volume.,” said Reg Seeto, President and Chief Executive Officer of CareDx. “We are proud to lead with innovation, and as a company 100% dedicated to transplant, to be champions of patient care and science and to fight for truth for the transplant community.”

First Quarter 2022 Financial Results

Revenue for the three months ended March 31, 2022 was $79.4 million, an increase of 18% compared with $67.4 million in the first quarter of 2021. Testing services revenue for the first quarter was $66.4 million, compared with $59.3 million in the same period of 2021. Product revenue in the three months ended March 31, 2022 was $6.8 million, compared to $5.8 million in the same period of 2021. Patient and digital solutions revenue for the first quarter of 2022 was $6.2 million, compared to $2.3 million in the same period of 2021.

For the first quarter of 2022, net loss was $19.6 million compared to a net loss of $0.7 million in the same period of 2021. Basic and diluted net loss per share was $0.37 in the first quarter of 2022, compared to basic and diluted net loss per share of $0.01 in the first quarter of 2021.

Non-GAAP net loss was $6.8 million in the first quarter of 2022 compared to a $7.2 million non-GAAP net income in the first quarter of 2021. Diluted non-GAAP net loss per share was $0.13 in the first quarter of 2022, compared to a diluted non-GAAP net income per share of $0.14 in the first quarter of 2021.

Adjusted EBITDA for the first quarter of 2022 was a loss of $5.6 million, compared to an adjusted EBITDA gain of $7.7 million in the first quarter of 2021.

Cash, cash equivalents and marketable securities were $319.2 million as of March 31, 2022.

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.

2022 Guidance

For the full year 2022, CareDx reiterates its revenue expectations in the range of $330 million to $350 million.

About CareDx – The Transplant Company

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, patient and digital 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 2022 revenue. 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, 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 SEC, including the Annual Report on Form 10-K for the fiscal year ended December 31, 2021 filed by CareDx with the SEC on February 24, 2022, 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/(loss), non-GAAP basic and diluted net income/(loss) per share and adjusted EBITDA. We define non-GAAP net income/(loss) and per share results as the GAAP net income (loss) and per share results excluding the impacts of stock-based compensation; changes in fair value of equity investments, 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.

Contacts

CareDx, Inc.
Sasha King
Chief Marketing Officer
415-287-2393
sking@CareDx.com 

Investor Relations
Ian Cooney
415-722-4563
investor@CareDx.com 


CareDx, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except share and per share data)

 Three Months Ended March 31,
 2022 2021
Revenue:   
Testing services revenue$66,444  $59,281 
Product revenue 6,788   5,778 
Patient and digital solutions revenue 6,184   2,341 
Total revenue 79,416   67,400 
Operating expenses:   
Cost of testing services 17,628   16,483 
Cost of product 4,399   3,647 
Cost of patient and digital solutions 4,855   1,449 
Research and development 21,880   16,004 
Sales and marketing 23,148   15,452 
General and administrative 26,559   15,223 
Total operating expenses 98,469   68,258 
Loss from operations (19,053)  (858)
Other income (expense):   
Interest income, net 189   126 
Change in estimated fair value of common stock warrant liability 27   27 
Other expense, net (823)  (245)
Total other expense (607)  (92)
Loss before income taxes (19,660)  (950)
Income tax benefit 12   263 
Net loss$(19,648) $(687)
Net loss per share:   
Basic$(0.37) $(0.01)
Diluted$(0.37) $(0.01)
Weighted-average shares used to compute net loss per share:   
Basic 53,015,459   51,181,160 
Diluted 53,015,459   51,181,160 


CareDx, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands)

 March 31, 2022 December 31, 2021
Assets   
Current assets:   
Cash and cash equivalents$171,892  $348,485 
Marketable securities 147,330   — 
Accounts receivable 65,320   59,761 
Inventory 18,212   17,186 
Prepaid and other current assets 8,733   7,928 
Total current assets 411,487   433,360 
Property and equipment, net 27,564   22,044 
Operating leases right-of-use assets 17,122   17,993 
Intangible assets, net 48,149   50,195 
Goodwill 36,983   36,983 
Restricted cash 214   211 
Other assets 5,192   5,835 
Total assets$546,711  $566,621 
Liabilities and stockholders’ equity   
Current liabilities:   
Accounts payable$10,605  $13,337 
Accrued compensation 11,418   26,042 
Accrued and other liabilities 44,897   37,922 
Total current liabilities 66,920   77,301 
Deferred tax liability 194   415 
Common stock warrant liability 112   139 
Deferred payments for intangible assets 4,959   5,041 
Operating lease liability, less current portion 16,729   17,394 
Other liabilities 253   455 
Total liabilities 89,167   100,745 
Commitments and contingencies   
Stockholders’ equity:   
Common stock 52   52 
Additional paid-in capital 865,419   853,683 
Accumulated other comprehensive loss (5,090)  (4,670)
Accumulated deficit (402,837)  (383,189)
Total stockholders’ equity 457,544   465,876 
Total liabilities and stockholders’ equity$546,711  $566,621 


CareDx, Inc.
Reconciliation of GAAP to Non-GAAP Financial Measures
(Unaudited)
(In thousands)

 Three Months Ended March 31,
 2022 2021
Cost of testing services reconciliation:   
GAAP cost of testing services$17,628  $16,483 
Stock-based compensation expense (19)  (395)
Acquisition related-amortization of purchased intangibles (329)  (329)
Non-GAAP cost of testing services$17,280  $15,759 
Cost of product reconciliation:   
GAAP cost of product$4,399  $3,647 
Stock-based compensation expense (128)  (76)
Acquisition related-amortization of purchased intangibles (453)  (465)
Non-GAAP cost of product$3,818  $3,106 
Cost of patient and digital solutions reconciliation:   
GAAP cost of patient and digital solutions$4,855  $1,449 
Stock-based compensation expense (192)  (108)
Acquisition related-amortization of purchased intangibles (236)  (108)
Non-GAAP cost of patient and digital solutions$4,427  $1,233 
Research and development expenses reconciliation:   
GAAP research and development expenses$21,880  $16,004 
Stock-based compensation expense (2,190)  (1,358)
Non-GAAP research and development expenses$19,690  $14,646 
Sales and marketing expenses reconciliation:   
GAAP sales and marketing expenses$23,148  $15,452 
Stock-based compensation expense (3,123)  (1,659)
Acquisition related-amortization of purchased intangibles (605)  (381)
Non-GAAP sales and marketing expenses$19,420  $13,412 
General and administrative expenses reconciliation:   
GAAP general and administrative expenses$26,559  $15,223 
Stock-based compensation expense (4,982)  (2,951)
Change in estimated fair value of contingent consideration (64)  44 
Acquisition related fees and expenses (143)  (171)
Non-GAAP general and administrative expenses$21,370  $12,145 
Total other income (expense) reconciliation:   
GAAP other expense, net$(607) $(92)
Unrealized loss on long-term marketable equity securities 507   — 
Change in estimated fair value of common stock warrant liability (27)  (27)
Accretion of liability 55   80 
Non-GAAP other expense, net$(72) $(39)
Income tax benefit reconciliation:   
GAAP income tax benefit$12  $263 
Tax effect related to amortization of purchased intangibles (113)  (134)
Non-GAAP income tax (loss) benefit$(101) $129 


CareDx, Inc.
Reconciliation of GAAP to Non-GAAP Financial Measures
(Unaudited)
(In thousands, except share and per share data)

 Three Months Ended March 31,
  2022   2021 
GAAP net loss$(19,648) $(687)
Stock-based compensation expense 10,634   6,547 
Unrealized loss on long-term marketable equity securities 507   — 
Acquisition related-amortization of purchased intangibles 1,623   1,283 
Acquisition related fees and expenses 143   171 
Change in estimated fair value of contingent consideration 64   (44)
Change in estimated fair value of common stock warrant liability (27)  (27)
Accretion of liability 55   80 
Tax effect related to amortization of purchased intangibles (113)  (134)
Non-GAAP net (loss) income$(6,762) $7,189 
    
GAAP basic and diluted net loss per share$(0.37) $(0.01)
    
Non-GAAP basic net (loss) income per share$(0.13) $0.14 
Non-GAAP diluted net (loss) income per share$(0.13) $0.14 
    
Shares used in computing non-GAAP basic net loss/income per share 53,015,459   51,181,160 
Shares used in computing non-GAAP diluted net loss/income per share 53,015,459   52,528,894 


CareDx, Inc.
Reconciliation of Non-GAAP to Adjusted EBITDA Financial Measures
(Unaudited)
(In thousands)

 Three Months Ended March 31,
 2022 2021
Non-GAAP net (loss) income$(6,762) $7,189 
Interest income (189)  (126)
Income tax benefit 101   (129)
Depreciation expense 940   587 
Other expense, net 261   165 
Adjusted EBITDA$(5,649) $7,686