CareDx Reports Second Quarter 2024 Results and Increases Revenue Guidance

CareDx, Inc. (Nasdaq: CDNA) – today announced financial results for the second quarter ended June 30, 2024.

Second Quarter 2024 Financial Highlights

  • Reported total revenue of $92.3 million, an increase of 31% year-over-year.
  • Grew Testing Services volume to 43,700 tests, an increase of 17% year-over-year.
  • Reported GAAP net loss of $1.4 million, non-GAAP net income of $13.6 million, and positive adjusted EBITDA of $12.9 million, a significant improvement from the second quarter 2023.
  • Generated $18.9 million cash from operations. Ended the quarter with cash, cash equivalents, and marketable securities of approximately $228.9 million, with no debt.
  • Raised 2024 guidance for annual revenue to $320 to $328 million and adjusted EBITDA to a gain of $9 to $15 million.

Business Highlights

  • In the first half of 2024, expanded coverage by 27 million lives nationwide.
  • Published SHORE study data demonstrating that HeartCare® outperforms dd-cfDNA alone in identifying allograft rejection.​
  • Nature Medicine publication validates CareDx AlloView™ AI-enabled risk prediction model and demonstrates AlloSure® Kidney detects subclinical rejection in stable patients​.

"We are pleased to announce another strong quarter, marked by growth across all our businesses. The hard work of our team and their dedication to serving transplant patients over the past year have been instrumental in our performance. As we approach the second half of the year, we remain focused on driving growth," said John W. Hanna, CareDx President and CEO.

Second Quarter 2024 Financial Results

Total revenue for the three months ended June 30, 2024, was $92.3 million, an increase of 31% compared to $70.3 million for the second quarter of 2023. Testing Services revenue for the second quarter 2024 was $70.9 million, an increase of 33% compared to $53.4 million for the second quarter of 2023. Testing Services revenue for the second quarter 2024 included $13.2 million for tests performed in prior periods. Patient and Digital Solutions revenue for the second quarter of 2024 was $10.7 million, an increase of 19% compared to $9.0 million for the second quarter 2023. Product revenue for the second quarter of 2024 was $10.6 million, an increase of 35% compared to $7.9 million for the second quarter 2023.

For the second quarter of 2024 net loss was $1.4 million compared to a net loss of $25.0 million in the second quarter of 2023. Basic and diluted net loss per share in the second quarter of 2024 was $0.03, compared to basic and diluted net loss per share of $0.46 in the second quarter of 2023.

Non-GAAP net income was $13.6 million in the second quarter of 2024, compared to a non-GAAP net loss of $9.9 million in the second quarter of 2023. Diluted non-GAAP net income per share was $0.25 in the second quarter of 2024, compared to a diluted non-GAAP net loss per share of $0.18 in the second quarter of 2023.

Adjusted EBITDA income for the second quarter of 2024 was $12.9 million, compared to an adjusted EBITDA loss of $10.4 million for the second quarter of 2023.

2024 Guidance

CareDx now expects full year 2024 revenue to be in the range of $320 million to $328 million, compared to the prior range of $274 million to $282 million. CareDx now expects full year 2024 non-GAAP gross margin to be in the range of 67% to 68%, compared to the prior range of 63% to 65%. CareDx now expects full year 2024 adjusted EBITDA gain to be in the range of $9 million to $15 million, compared to an adjusted EBITDA loss of $14 million to $24 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, non-GAAP gross margin and adjusted EBITDA, 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, 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, the quarterly report on Form 10-Q for the quarter ended March 31, 2024 filed by CareDx with the SEC on May 9, 2024, the quarterly report on Form 10-Q for the quarter ended June 30, 2024 filed by CareDx with the SEC on July 31, 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 income (loss), non-GAAP basic and diluted net income (loss) per share, adjusted EBITDA and non-GAAP operating expenses.

We define non-GAAP net income (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; restructuring charges and certain other charges.

We define adjusted EBITDA as non-GAAP net income (loss) before interest income, income tax expense (benefit), depreciation and other 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.

Condensed Consolidated Statements of Operations

(Unaudited)

(In thousands, except share and per share data)

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

Revenue:

 

 

 

 

 

 

 

Testing services revenue

$

70,918

 

 

$

53,414

 

 

$

124,755

 

 

$

115,198

 

Product revenue

 

10,610

 

 

 

7,876

 

 

 

19,204

 

 

 

14,737

 

Patient and digital solutions revenue

 

10,746

 

 

 

9,011

 

 

 

20,364

 

 

 

17,628

 

Total revenue

 

92,274

 

 

 

70,301

 

 

 

164,323

 

 

 

147,563

 

Operating expenses:

 

 

 

 

 

 

 

Cost of testing services

 

14,308

 

 

 

15,324

 

 

 

27,940

 

 

 

30,620

 

Cost of product

 

6,245

 

 

 

3,926

 

 

 

11,589

 

 

 

7,992

 

Cost of patient and digital solutions

 

7,393

 

 

 

6,637

 

 

 

14,351

 

 

 

13,241

 

Research and development

 

19,678

 

 

 

20,233

 

 

 

38,389

 

 

 

44,590

 

Sales and marketing

 

21,002

 

 

 

21,630

 

 

 

40,832

 

 

 

44,861

 

General and administrative

 

27,678

 

 

 

29,327

 

 

 

54,589

 

 

 

57,359

 

Restructuring costs

 

68

 

 

 

848

 

 

 

68

 

 

 

848

 

Total operating expenses

 

96,372

 

 

 

97,925

 

 

 

187,758

 

 

 

199,511

 

Loss from operations

 

(4,098

)

 

 

(27,624

)

 

 

(23,435

)

 

 

(51,948

)

Other income:

 

 

 

 

 

 

 

Interest income, net

 

2,826

 

 

 

2,871

 

 

 

5,711

 

 

 

5,537

 

Change in estimated fair value of common stock warrant liability

 

 

 

 

3

 

 

 

 

 

 

10

 

Other expense, net

 

(100

)

 

 

(271

)

 

 

(390

)

 

 

(2,245

)

Total other income

 

2,726

 

 

 

2,603

 

 

 

5,321

 

 

 

3,302

 

Loss before income taxes

 

(1,372

)

 

 

(25,021

)

 

 

(18,114

)

 

 

(48,646

)

Income tax (expense) benefit

 

(22

)

 

 

68

 

 

 

61

 

 

 

(56

)

Net loss

$

(1,394

)

 

$

(24,953

)

 

$

(18,053

)

 

$

(48,702

)

Net loss per share:

 

 

 

 

 

 

 

Basic

$

(0.03

)

 

$

(0.46

)

 

$

(0.35

)

 

$

(0.91

)

Diluted

$

(0.03

)

 

$

(0.46

)

 

$

(0.35

)

 

$

(0.91

)

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

 

 

 

 

 

 

 

Basic

 

52,195,620

 

 

 

53,846,260

 

 

 

51,943,989

 

 

 

53,745,299

 

Diluted

 

52,195,620

 

 

 

53,846,260

 

 

 

51,943,989

 

 

 

53,745,299

 

CareDx, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands)

 

 

June 30, 2024

 

December 31, 2023

Assets

 

 

 

Current assets:

 

 

 

Cash and cash equivalents

$

95,782

 

 

$

82,197

 

Marketable securities

 

133,089

 

 

 

153,221

 

Accounts receivable

 

66,161

 

 

 

51,061

 

Inventory

 

19,234

 

 

 

19,471

 

Prepaid and other current assets

 

6,343

 

 

 

7,763

 

Total current assets

 

320,609

 

 

 

313,713

 

Property and equipment, net

 

34,202

 

 

 

35,246

 

Operating leases right-of-use assets

 

27,188

 

 

 

29,891

 

Intangible assets, net

 

41,896

 

 

 

45,701

 

Goodwill

 

40,336

 

 

 

40,336

 

Restricted cash

 

588

 

 

 

586

 

Other assets

 

1,958

 

 

 

1,353

 

Total assets

$

466,777

 

 

$

466,826

 

Liabilities and stockholders’ equity

 

 

 

Current liabilities:

 

 

 

Accounts payable

$

5,874

 

 

$

12,872

 

Accrued compensation

 

25,004

 

 

 

19,703

 

Accrued and other liabilities

 

47,453

 

 

 

45,497

 

Total current liabilities

 

78,331

 

 

 

78,072

 

Deferred tax liability

 

50

 

 

 

136

 

Deferred payments for intangible assets

 

1,620

 

 

 

2,461

 

Operating lease liability, less current portion

 

25,386

 

 

 

28,278

 

Other liabilities

 

96,721

 

 

 

96,551

 

Total liabilities

 

202,108

 

 

 

205,498

 

Commitments and contingencies

 

 

 

Stockholders’ equity:

 

 

 

Common stock

 

50

 

 

 

49

 

Additional paid-in capital

 

969,427

 

 

 

946,511

 

Accumulated other comprehensive loss

 

(7,964

)

 

 

(6,963

)

Accumulated deficit

 

(696,844

)

 

 

(678,269

)

Total stockholders’ equity

 

264,669

 

 

 

261,328

 

Total liabilities and stockholders’ equity

$

466,777

 

 

$

466,826

 

CareDx, Inc.

Reconciliation of GAAP to Non-GAAP Financial Measures

(Unaudited)

(In thousands)

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

Cost of testing services reconciliation:

 

 

 

 

 

 

 

GAAP cost of testing services

$

14,308

 

 

$

15,324

 

 

$

27,940

 

 

$

30,620

 

Stock-based compensation expense

 

(357

)

 

 

(492

)

 

 

(814

)

 

 

(971

)

Acquisition related-amortization of purchased intangibles

 

(329

)

 

 

(329

)

 

 

(658

)

 

 

(658

)

Non-GAAP cost of testing services

$

13,622

 

 

$

14,503

 

 

$

26,468

 

 

$

28,991

 

Cost of product reconciliation:

 

 

 

 

 

 

 

GAAP cost of product

$

6,298

 

 

$

3,926

 

 

$

11,642

 

 

$

7,992

 

Stock-based compensation expense

 

(225

)

 

 

(274

)

 

 

(542

)

 

 

(634

)

Acquisition related-amortization of purchased intangibles

 

(411

)

 

 

(416

)

 

 

(831

)

 

 

(834

)

Restructuring costs

 

(53

)

 

 

 

 

 

(53

)

 

 

 

Non-GAAP cost of product

$

5,609

 

 

$

3,236

 

 

$

10,216

 

 

$

6,524

 

Cost of patient and digital solutions reconciliation:

 

 

 

 

 

 

 

GAAP cost of patient and digital solutions

$

7,393

 

 

$

6,651

 

 

$

14,351

 

 

$

13,255

 

Stock-based compensation expense

 

(350

)

 

 

(367

)

 

 

(722

)

 

 

(769

)

Acquisition related-amortization of purchased intangibles

 

(238

)

 

 

(255

)

 

 

(509

)

 

 

(503

)

Restructuring costs

 

 

 

 

(14

)

 

 

 

 

 

(14

)

Other income

 

 

 

 

 

 

 

5

 

 

 

 

Non-GAAP cost of patient and digital solutions

$

6,805

 

 

$

6,015

 

 

$

13,125

 

 

$

11,969

 

Research and development expenses reconciliation:

 

 

 

 

 

 

 

GAAP research and development expenses

$

19,693

 

 

$

20,478

 

 

$

38,404

 

 

$

44,835

 

Stock-based compensation expense

 

(1,628

)

 

 

(1,704

)

 

 

(3,388

)

 

 

(3,666

)

Restructuring costs

 

(15

)

 

 

(245

)

 

 

(15

)

 

 

(245

)

Other charges

 

 

 

 

 

 

 

(25

)

 

 

 

Non-GAAP research and development expenses

$

18,050

 

 

$

18,529

 

 

$

34,976

 

 

$

40,924

 

Sales and marketing expenses reconciliation:

 

 

 

 

 

 

 

GAAP sales and marketing expenses

$

21,002

 

 

$

22,178

 

 

$

40,832

 

 

$

45,409

 

Stock-based compensation expense

 

(2,927

)

 

 

(2,779

)

 

 

(5,971

)

 

 

(6,516

)

Acquisition related-amortization of purchased intangibles

 

(628

)

 

 

(606

)

 

 

(1,261

)

 

 

(1,201

)

Restructuring costs

 

 

 

 

(548

)

 

 

 

 

 

(548

)

Other charges

 

 

 

 

 

 

 

(8

)

 

 

 

Non-GAAP sales and marketing expenses

$

17,447

 

 

$

18,245

 

 

$

33,592

 

 

$

37,144

 

General and administrative expenses reconciliation:

 

 

 

 

 

 

 

GAAP general and administrative expenses

$

27,678

 

 

$

29,368

 

 

$

54,589

 

 

$

57,400

 

Stock-based compensation expense

 

(7,683

)

 

 

(7,084

)

 

 

(15,077

)

 

 

(13,898

)

Change in estimated fair value of contingent consideration

 

(210

)

 

 

(67

)

 

 

(529

)

 

 

(488

)

Acquisition related fees and expenses

 

(5

)

 

 

 

 

 

(40

)

 

 

(284

)

Restructuring costs and charges

 

 

 

 

(41

)

 

 

 

 

 

(99

)

Other (charges) income

 

(44

)

 

 

 

 

 

22

 

 

 

 

Non-GAAP general and administrative expenses

$

19,736

 

 

$

22,176

 

 

$

38,965

 

 

$

42,631

 

Total other income (expense) reconciliation:

 

 

 

 

 

 

 

GAAP other income, net

$

2,726

 

 

$

2,603

 

 

$

5,321

 

 

$

3,302

 

Unrealized (gain) loss on long-term marketable equity securities

 

 

 

 

(53

)

 

 

 

 

 

857

 

Asset impairments and write-downs

 

 

 

 

 

 

 

 

 

 

1,000

 

Other charges

 

 

 

 

7

 

 

 

 

 

 

28

 

Non-GAAP other income, net

$

2,726

 

 

$

2,557

 

 

$

5,321

 

 

$

5,187

 

Income tax (expense) benefit reconciliation:

 

 

 

 

 

 

 

GAAP income tax (expense) benefit

$

(22

)

 

$

68

 

 

$

61

 

 

$

(56

)

Tax effect related to amortization of purchased intangibles

 

(98

)

 

 

(100

)

 

 

(200

)

 

 

(201

)

Non-GAAP income tax expense

$

(120

)

 

$

(32

)

 

$

(139

)

 

$

(257

)

CareDx, Inc.

GAAP and Non-GAAP Operating Expenses

(Unaudited)

(In thousands)

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

GAAP operating expenses:

 

 

 

 

 

 

 

Research and development

$

19,693

 

$

20,478

 

$

38,404

 

$

44,835

Sales and marketing

 

21,002

 

 

 

22,178

 

 

 

40,832

 

 

 

45,409

 

General and administrative

 

27,678

 

 

 

29,368

 

 

 

54,589

 

 

 

57,400

 

Total GAAP operating expenses

$

68,373

 

 

$

72,024

 

 

$

133,825

 

 

$

147,644

 

 

 

 

 

 

 

 

 

Non-GAAP operating expenses:

 

 

 

 

 

 

 

Research and development

$

18,050

 

 

$

18,529

 

 

$

34,976

 

 

$

40,924

 

Sales and marketing

 

17,447

 

 

 

18,245

 

 

 

33,592

 

 

 

37,144

 

General and administrative

 

19,736

 

 

 

22,176

 

 

 

38,965

 

 

 

42,631

 

Total Non-GAAP operating expenses

$

55,233

 

 

$

58,950

 

 

$

107,533

 

 

$

120,699

 

CareDx, Inc.

Reconciliation of GAAP to Non-GAAP Gross Profit and Gross Margin

(Unaudited)

(In thousands, except percentages)

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

Total revenue

$

92,274

 

 

$

70,301

 

 

$

164,323

 

 

$

147,563

 

GAAP cost of sales

 

27,999

 

 

 

25,901

 

 

 

53,933

 

 

 

51,867

 

GAAP gross profit

 

64,275

 

 

 

44,400

 

 

 

110,390

 

 

 

95,696

 

Stock-based compensation expense

 

932

 

 

 

1,133

 

 

 

2,078

 

 

 

2,374

 

Other income

 

 

 

 

 

 

 

(5

)

 

 

 

Restructuring costs

 

53

 

 

 

14

 

 

 

53

 

 

 

14

 

Acquisition related-amortization of purchased intangibles

 

978

 

 

 

1,000

 

 

 

1,998

 

 

 

1,995

 

Non-GAAP gross profit

$

66,238

 

 

$

46,547

 

 

$

114,514

 

 

$

100,079

 

Non-GAAP gross margin %

 

72

%

 

 

66

%

 

 

70

%

 

 

68

%

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,

 

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

GAAP net loss

$

(1,394

)

 

$

(24,953

)

 

$

(18,053

)

 

$

(48,702

)

Stock-based compensation expense

 

13,170

 

 

 

12,700

 

 

 

26,514

 

 

 

26,454

 

Acquisition related-amortization of purchased intangibles

 

1,606

 

 

 

1,606

 

 

 

3,259

 

 

 

3,196

 

Change in estimated fair value of contingent consideration

 

210

 

 

 

67

 

 

 

529

 

 

 

488

 

Acquisition related fees and expenses

 

5

 

 

 

 

 

 

40

 

 

 

284

 

Other charges

 

44

 

 

 

7

 

 

 

6

 

 

 

28

 

Restructuring costs and charges

 

68

 

 

 

848

 

 

 

68

 

 

 

906

 

Tax effect related to amortization of purchased intangibles

 

(98

)

 

 

(100

)

 

 

(200

)

 

 

(201

)

Asset impairments and write-downs

 

 

 

 

 

 

 

 

 

 

1,000

 

Unrealized (gain) loss on long-term marketable equity securities

 

 

 

 

(53

)

 

 

 

 

 

857

 

Non-GAAP net income (loss)

$

13,611

 

 

$

(9,878

)

 

$

12,163

 

 

$

(15,690

)

 

 

 

 

 

 

 

 

GAAP basic and diluted net loss per share

$

(0.03

)

 

$

(0.46

)

 

$

(0.35

)

 

$

(0.91

)

 

 

 

 

 

 

 

 

Non-GAAP basic net income (loss) per share

$

0.26

 

 

$

(0.18

)

 

$

0.23

 

 

$

(0.29

)

Non-GAAP diluted net income (loss) per share

$

0.25

 

 

$

(0.18

)

 

$

0.23

 

 

$

(0.29

)

 

 

 

 

 

 

 

 

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

 

52,195,620

 

 

 

53,846,260

 

 

 

51,943,989

 

 

 

53,745,299

 

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

 

54,333,731

 

 

 

53,846,260

 

 

 

53,669,762

 

 

 

53,745,299

 

CareDx, Inc.

Reconciliation of Non-GAAP to Adjusted EBITDA

(Unaudited)

(In thousands)

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

Non-GAAP net income (loss)

$

13,611

 

 

$

(9,878

)

 

$

12,163

 

 

$

(15,690

)

Interest income

 

(2,826

)

 

 

(2,871

)

 

 

(5,711

)

 

 

(5,537

)

Income tax expense (benefit)

 

121

 

 

 

68

 

 

 

139

 

 

 

(56

)

Depreciation expense

 

1,937

 

 

 

2,052

 

 

 

4,105

 

 

 

3,860

 

Other expense, net

 

100

 

 

 

279

 

 

 

390

 

 

 

664

 

Adjusted EBITDA

$

12,943

 

 

$

(10,350

)

 

$

11,086

 

 

$

(16,759

)

 

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