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CareDx Reports First Quarter 2021 Results

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Strong start to 2021, raising full year guidance

SOUTH SAN FRANCISCO, Calif., May 05, 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 first quarter ended March 31, 2021.

Recent Highlights:

  • Achieved total revenue of $67.4 million for the three months ended March 31, 2021, increasing 76% year-over-year

  • Total AlloSure and AlloMap patient results provided in the quarter were approximately 33,200, which includes approximately 5,900 AlloSure Heart patient results

  • As of March 31, 2021, over 60 U.S.-based transplant centers have adopted an AlloSure Kidney testing protocol, and we now connect more than 20,000 dialysis patients seeking to be referred for transplant with over 30 centers and greater than 500 dialysis centers through Tx Connect

  • Completed successful public offering raising approximately $188.7 million in net proceeds, increasing cash, cash equivalents and marketable securities to $374.3 million as of March 31, 2021

"Our record first quarter is a testament to the transplant focused, patient journey driven approach we have taken, as we deliver on our vision on being the leader in the transplant ecosystem," said Reg Seeto, President and Chief Executive Officer of CareDx. "2021 has started off strong because we continue to lead with innovation with our first and best in class offerings with AlloSure and AlloMap. Our strategy to bring multi-modality innovation and to connect the patient journey is working very well."

First Quarter 2021 Financial Results

Revenue for the three months ended March 31, 2021 was $67.4 million, an increase of 76% compared with $38.4 million in the first quarter of 2020. Testing services revenue for the first quarter was $59.3 million, compared with $31.4 million in the same period of 2020. Product revenue in the three months ended March 31, 2021 was $5.8 million, compared to $4.7 million in the same period of 2020. Digital and other revenue for the first quarter of 2021 was $2.3 million.

For the first quarter of 2021, net loss was $0.7 million compared to a net loss of $5.8 million in the same period of 2020. Basic and diluted net loss per share was $0.01 in the first quarter of 2021, compared to basic and diluted net loss per share of $0.14 in the first quarter of 2020.

Non-GAAP net income was $7.2 million in the first quarter of 2021 compared to a $0.2 million non-GAAP net income in the first quarter of 2020. Diluted non-GAAP net income per share was $0.14 in the first quarter of 2021, compared to a diluted non-GAAP net income per share of $0.00 in the first quarter of 2020.

Adjusted EBITDA for the first quarter of 2021 was a gain of $7.7 million, compared to an adjusted EBITDA gain of $0.2 million in the first quarter of 2020.

Cash, cash equivalents & marketable securities were $374.3 million as of March 31, 2021. In January, the Company repaid the entire amount of the CMS advance payment of $20.5 million received in April 2020. In January and February, the aggregate net proceeds of cash raised in a public offering were approximately $188.7 million.

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 $270 million to $280 million (previously $255 million to $265 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; 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

Greg Chodaczek
347-620-7010
investor@caredx.com

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

Three Months Ended March 31,

2021

2020

Revenue:

Testing services revenue

$

59,281

$

31,442

Product revenue

5,778

4,695

Digital and other revenue

2,341

2,243

Total revenue

67,400

38,380

Operating expenses:

Cost of testing services

16,483

7,928

Cost of product

3,647

3,199

Cost of digital and other

1,449

1,265

Research and development

16,004

10,013

Sales and marketing

15,452

11,723

General and administrative

15,223

10,003

Total operating expenses

68,258

44,131

Loss from operations

(858

)

(5,751

)

Other income (expense):

Interest income, net

126

96

Change in estimated fair value of common stock warrant liability

27

(405

)

Other expense, net

(245

)

(63

)

Total other (expense) income

(92

)

(372

)

Loss before income taxes

(950

)

(6,123

)

Income tax benefit

263

300

Net loss

$

(687

)

$

(5,823

)

Net loss per share:

Basic

$

(0.01

)

$

(0.14

)

Diluted

$

(0.01

)

$

(0.14

)

Weighted-average shares used to compute net loss per share:

Basic

51,181,160

42,823,427

Diluted

51,181,160

42,823,427



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

March 31, 2021

December 31, 2020

Assets

Current assets:

Cash and cash equivalents

$

309,324

$

134,669

Marketable securities

64,963

90,034

Accounts receivable

43,361

34,624

Inventory

13,721

10,012

Prepaid and other current assets

7,332

3,758

Total current assets

438,701

273,097

Property and equipment, net

11,398

10,704

Operating leases right-of-use assets

18,289

15,228

Intangible assets, net

45,457

44,355

Goodwill

26,109

23,857

Restricted cash

269

270

Other assets

1,000

1,000

Total assets

$

541,223

$

368,511

Liabilities and stockholders' equity

Current liabilities:

Accounts payable

$

11,597

$

9,653

Accrued compensation

10,495

18,466

Accrued and other liabilities

23,638

20,602

Refund liability - CMS advance payment

20,496

Total current liabilities

45,730

69,217

Deferred tax liability

945

1,299

Common stock warrant liability

420

447

Deferred payments for intangible assets

3,640

3,560

Operating lease liability, less current portion

18,462

16,069

Other liabilities

480

240

Total liabilities

69,677

90,832

Commitments and contingencies

Stockholders’ equity:

Common stock

51

49

Additional paid-in capital

828,308

632,253

Accumulated other comprehensive loss

(3,599

)

(2,096

)

Accumulated deficit

(353,214

)

(352,527

)

Total stockholders' equity

471,546

277,679

Total liabilities and stockholders' equity

$

541,223

$

368,511



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

Three Months Ended March 31,

2021

2020

Cost of testing services reconciliation:

GAAP cost of testing services

$

16,483

$

7,928

Stock-based compensation expense

(395

)

(247

)

Acquisition related-amortization of purchased intangibles

(329

)

(329

)

Non-GAAP cost of testing services

$

15,759

$

7,352

Cost of product reconciliation:

GAAP cost of product

$

3,647

$

3,199

Stock-based compensation expense

(76

)

(59

)

Acquisition related-amortization of purchased intangibles

(465

)

(377

)

Non-GAAP cost of product

$

3,106

$

2,763

Cost of digital and other reconciliation:

GAAP cost of digital and other

$

1,449

$

1,265

Stock-based compensation expense

(108

)

(59

)

Acquisition related-amortization of purchased intangibles

(108

)

(86

)

Non-GAAP cost of digital and other

$

1,233

$

1,120

Research and development expenses reconciliation:

GAAP research and development expenses

$

16,004

$

10,013

Stock-based compensation expense

(1,358

)

(810

)

Non-GAAP research and development expenses

$

14,646

$

9,203

Sales and marketing expenses reconciliation:

GAAP sales and marketing expenses

$

15,452

$

11,723

Stock-based compensation expense

(1,659

)

(971

)

Acquisition related-amortization of purchased intangibles

(381

)

(357

)

Impairment

Non-GAAP sales and marketing expenses

$

13,412

$

10,395

General and administrative expenses reconciliation:

GAAP general and administrative expenses

$

15,223

$

10,003

Stock-based compensation expense

(2,951

)

(2,113

)

Change in estimated fair value of contingent consideration

44

(190

)

Acquisition related fees and expenses

(171

)

Non-GAAP general and administrative expenses

$

12,145

$

7,700

Total other income (expense) reconciliation:

GAAP other expense, net

$

(92

)

$

(372

)

Change in estimated fair value of common stock warrant liability

(27

)

405

Accretion of liability

80

104

Non-GAAP other (expense) income, net

$

(39

)

$

137

Income tax benefit reconciliation:

GAAP income tax benefit

$

263

$

300

Tax effect related to amortization of purchased intangibles

(134

)

(120

)

Non-GAAP income tax benefit

$

129

$

180



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

Three Months Ended March 31,

2021

2020

Net loss

$

(687

)

$

(5,823

)

Stock-based compensation expense

6,547

4,259

Acquisition related-amortization of purchased intangibles

1,283

1,149

Acquisition related fees and expenses

171

Change in estimated fair value of contingent consideration

(44

)

190

Change in estimated fair value of common stock warrant liability

(27

)

405

Accretion of liability

80

104

Tax effect related to amortization of purchased intangibles

(134

)

(120

)

Non-GAAP net income

$

7,189

$

164

GAAP basic and diluted net loss per share

$

(0.01

)

$

(0.14

)

Non-GAAP basic net income per share

$

0.14

$

0.00

Non-GAAP diluted net income per share

$

0.14

$

0.00

Shares used in computing non-GAAP basic net income per share

51,181,160

42,823,427

Shares used in computing non-GAAP diluted net income per share

52,528,894

43,606,998



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

Three Months Ended March 31,

2021

2020

Non-GAAP net income

$

7,189

$

164

Interest income

(126

)

(96

)

Income tax benefit

(129

)

(180

)

Depreciation expense

587

367

Other expense (income), net

165

(41

)

Adjusted EBITDA

$

7,686

$

214