CareDx Reports 77% Revenue Growth for Second Quarter of 2021 and Increases Full Year Revenue Guidance

Brisbane, California, UNITED STATES


SOUTH SAN FRANCISCO, Calif., July 29, 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 second quarter ended June 30, 2021.

Recent Highlights:

  • Achieved total revenue of $74.2 million for the three months ended June 30, 2021, increasing 77% year-over-year

  • Total AlloSure and AlloMap patient results provided in the quarter were approximately 37,400, which includes approximately 6,600 AlloSure Heart patient results

  • As of June 30, 2021, over 65 U.S.-based transplant centers have adopted an AlloSure Kidney testing protocol. In addition, TX Connect now manages more than 29,000 transplant referrals to over 50 transplant centers from more than 800 dialysis centers and community nephrology practices

  • Presented positive data from first 1,000 patients from KOAR Study demonstrating higher 1-year graft survival and reduction in biopsies through ARTS surveillance

"With another record quarter, we continue to lead the transformation of the transplant patient journey with our innovative and patient focused offerings," said Reg Seeto, President and Chief Executive Officer of CareDx. "We have become the transplant partner of choice by bringing industry leading service offerings with AlloSure and AlloMap to the clinic, as well as leading innovation with our multimodal platforms (HeartCare, KidneyCare), while we remain focused on the patient journey."

Second Quarter 2021 Financial Results

Revenue for the three months ended June 30, 2021 was $74.2 million, an increase of 77% compared with $41.8 million in the second quarter of 2020. Testing services revenue for the second quarter was $64.9 million, compared with $36.3 million in the same period of 2020. Product revenue in the three months ended June 30, 2021 was $6.9 million, compared to $3.3 million in the same period of 2020. Digital and other revenue for the second quarter of 2021 was $2.4 million.

For the second quarter of 2021, net loss was $1.9 million compared to a net loss of $6.6 million in the same period of 2020. Basic and diluted net loss per share was $0.04 in the second quarter of 2021, compared to basic and diluted net loss per share of $0.15 in the second quarter of 2020.

Non-GAAP net income was $5.9 million in the second quarter of 2021 compared to a $1.7 million non-GAAP net income in the second quarter of 2020. Diluted non-GAAP net income per share was $0.11 in the second quarter of 2021, compared to a diluted non-GAAP net income per share of $0.04 in the second quarter of 2020.

Adjusted EBITDA for the second quarter of 2021 was a gain of $6.8 million, compared to an adjusted EBITDA loss of $2.8 million in the second quarter of 2020.

Cash, cash equivalents & marketable securities were $369.9 million as of June 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 $280 million to $290 million (previously $270 million to $280 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 Cooney
(415) 287-2300 x3550
investor@caredx.com 


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

 Three Months Ended June 30, Six Months Ended June 30,
  2021 2020  2021 2020
      
Revenue:     
Testing services revenue$64,890 $36,293  $124,171 $67,735 
Product revenue 6,861  3,291   12,639  7,986 
Digital and other revenue 2,437  2,217   4,778  4,460 
Total revenue 74,188  41,801   141,588  80,181 
Operating expenses:     
Cost of testing services 17,235  10,803   33,718  18,731 
Cost of product 5,205  2,731   8,852  5,930 
Cost of digital and other 1,533  1,491   2,982  2,756 
Research and development 19,036  13,129   35,040  23,142 
Sales and marketing 19,599  12,134   35,051  23,857 
General and administrative 16,322  12,316   31,545  22,319 
Total operating expenses 78,930  52,604   147,188  96,735 
Loss from operations (4,742) (10,803)  (5,600) (16,554)
Other income (expense):     
Interest income, net 1  21   127  117 
Change in estimated fair value of common stock warrant liability (65) (664)  (38) (1,069)
CARES Act Provider Relief Fund -  4,813   -  4,813 
Other income (expense), net 2,779  (255)  2,534  (318)
Total other income 2,715  3,915   2,623  3,543 
Loss before income taxes (2,027) (6,888)  (2,977) (13,011)
Income tax benefit 100  330   363  630 
Net loss$(1,927)$(6,558) $(2,614)$(12,381)
Net loss per share:     
Basic$(0.04)$(0.15) $(0.05)$(0.28)
Diluted$(0.04)$(0.15) $(0.05)$(0.28)
      
Weighted average shares used to compute net loss per share:     
Basic 52,224,300  44,708,037   51,705,587  43,765,732 
Diluted 52,224,300  44,708,037   51,705,587  43,765,732 


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

 June 30, 2021 December 31, 2020
    
Assets   
Current assets:   
Cash and cash equivalents$335,625  $134,669 
Marketable securities 34,317   90,034 
Accounts receivable 48,066   34,624 
Inventory 15,060   10,012 
Prepaid and other current assets 7,928   3,758 
Total current assets 440,996   273,097 
Property and equipment, net 14,219   10,704 
Operating leases right-of-use assets 17,859   15,228 
Intangible assets, net 48,432   44,355 
Goodwill 26,051   23,857 
Restricted cash 268   270 
Other assets 9,590   1,000 
Total assets$557,415  $368,511 
Liabilities and stockholders' equity   
Current liabilities:   
Accounts payable$12,563  $9,653 
Accrued compensation 16,710   18,466 
Accrued and other liabilities 26,982   20,602 
Refund liability - CMS advanced payment -   20,496 
Total current liabilities 56,255   69,217 
Deferred tax liability 810   1,299 
Common stock warrant liability 283   447 
Deferred payments for intangible assets 1,968   3,560 
Operating lease liability, less current portion 17,783   16,069 
Other liabilities 473   240 
Total liabilities 77,572   90,832 
Commitments and contingencies   
Stockholders’ equity:   
Common stock 51   49 
Additional paid-in capital 838,089   632,253 
Accumulated other comprehensive loss (3,156)  (2,096)
Accumulated deficit (355,141)  (352,527)
Total stockholders' equity 479,843   277,679 
Total liabilities and stockholders' equity$557,415  $368,511 


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

 Three Months Ended June 30,  Six Months Ended June 30,
  2021 2020  2021 2020
Cost of testing services reconciliation:     
GAAP cost of testing services$17,235 $10,803  $33,718 $18,731 
Stock-based compensation expense (570) (423)  (965) (670)
Acquisition related-amortization of purchased intangibles (329) (329)  (658) (657)
Non-GAAP cost of testing services$16,336 $10,051  $32,095 $17,404 
Cost of product reconciliation:     
GAAP cost of product$5,205 $2,731  $8,852 $5,930 
Stock-based compensation expense (214) (133)  (289) (192)
Acquisition related-amortization of purchased intangibles (489) (388)  (954) (765)
Non-GAAP cost of product$4,502 $2,210  $7,609 $4,973 
Cost of digital and other reconciliation:     
GAAP cost of digital and other$1,533 $1,491  $2,982 $2,756 
Stock-based compensation expense (230) (155)  (338) (213)
Acquisition related-amortization of purchased intangibles (141) (87)  (249) (174)
Non-GAAP cost of digital and other$1,162 $1,249  $2,395 $2,369 
Research and development expenses reconciliation:     
GAAP research and development expenses$19,036 $13,129  $35,040 $23,142 
Stock-based compensation expense (1,940) (1,456)  (3,298) (2,267)
Non-GAAP research and development expenses$17,096 $11,673  $31,742 $20,875 
Sales and marketing expenses reconciliation:     
GAAP sales and marketing expenses$19,599 $12,134  $35,051 $23,857 
Stock-based compensation expense (2,632) (1,581)  (4,292) (2,550)
Acquisition related-amortization of purchased intangibles (461) (356)  (842) (713)
Non-GAAP sales and marketing expenses$16,506 $10,197  $29,917 $20,594 
General and administrative expenses reconciliation:     
GAAP general and administrative expenses$16,322 $12,316  $31,545 $22,319 
Stock-based compensation expense (3,811) (2,669)  (6,763) (4,784)
Change in estimated fair value of contingent consideration 147  (76)  191  (266)
Acquisition related fees and expenses (210) -   (381) - 
Non-GAAP general and administrative expenses$12,448 $9,571  $24,592 $17,269 
Total other income (expense) reconciliation:     
GAAP other income (expense), net$2,715 $3,915  $2,623 $3,543 
Unrealized gains on investments (3,090) -   (3,090) - 
Change in estimated fair value of common stock warrant liability 65  664   38  1,069 
Accretion of liability 64  88   144  192 
Non-GAAP other (expense) income, net$(246)$4,667  $(285)$4,804 
Income tax benefit reconciliation:     
GAAP income tax benefit$100 $330  $363 $630 
Tax effect related to amortization of purchased intangibles (117) (119)  (251) (239)
Non-GAAP income tax (expense) benefit$(17)$211  $112 $391 


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

 Three Months Ended June 30, Six Months Ended June 30,
  2021 2020  2021 2020
      
Net loss$(1,927)$(6,558) $(2,614)$(12,381)
Stock-based compensation expense 9,397  6,417   15,945  10,676 
Unrealized gain on long-term marketable securities (3,090) -   (3,090) - 
Acquisition related-amortization of purchased intangibles 1,420  1,160   2,703  2,309 
Acquisition related fees and expenses 210  -   381  - 
Change in estimated fair value of contingent consideration (147) 76   (191) 266 
Change in estimated fair value of common stock warrant liability 65  664   38  1,069 
Accretion of liability 64  88   144  192 
Tax effect related to amortization of purchased intangibles (117) (119)  (251) (239)
Non-GAAP net income$5,875 $1,728  $13,065 $1,892 
      
GAAP basic and diluted net loss per share$(0.04)$(0.15) $(0.05)$(0.28)
      
Non-GAAP basic net income per share$0.11 $0.04  $0.25 $0.04 
Non-GAAP diluted net income per share$0.11 $0.04  $0.24 $0.04 
      
Shares used in computing non-GAAP basic net income per share 52,224,300  44,708,037   51,705,587  43,765,732 
Shares used in computing non-GAAP diluted net income per share 54,722,122  45,882,569   54,311,138  44,604,886 


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

 Three Months Ended June 30, Six Months Ended June 30,
  2021 2020  2021 2020
      
Non-GAAP net income$5,875 $1,728  $13,065 $1,892 
Interest income (1) (21)  (127) (117)
Income tax expense (benefit) 17  (211)  (112) (391)
Depreciation expense 668  381   1,255  748 
CARES Act Provider Relief Fund -  (4,813)  -  (4,813)
Other expense, net 247  167   412  126 
Adjusted EBITDA$6,806 $(2,769) $14,493 $(2,555)