Caredx, Inc.NASDAQ: CDNA

CareDx Announces Fourth Quarter and Full Year 2023 Financial Results

· Issued by CareDx, Inc. via Business Wire

Delivered Total Revenue of $280.3 Million, Exceeding the High End of Updated Guidance for 2023

Grew Testing Services Results for the Second Quarter in a Row

BRISBANE, Calif.--(BUSINESS WIRE)-- CareDx, Inc. (Nasdaq: CDNA) today reported financial results for the fourth quarter and full year ended December 31, 2023.

Fourth Quarter and Full Year 2023 Highlights

  • Reported full year revenue of $280.3 million, exceeding the high end of updated guidance for 2023.
  • Reported full year Testing Services revenue of $209.7 million and delivered approximately 165,700 patient results in 2023.
  • Grew Testing Services patient results for the second quarter in a row to approximately 39,900, an increase of 4% as compared to the third quarter of 2023.
  • Reported full year revenue of $37.1 million for Patient and Digital Solutions and $33.5 million for Product, representing year-over-year growth of 29% and 15%, respectively.
  • Ended 2023 with cash and cash equivalents, and marketable securities of approximately $235.4 million, with no debt.
  • Achieved the fifth consecutive quarter of collections at over 100% of Testing Services revenue driven by revenue cycle management initiatives. Collected $17 million in cash over its revenue in 2023.
  • Repurchased 2.9 million shares of common stock for $27.5 million under share buyback program in 2023.
  • Received Medicare coverage for HeartCare and AlloSure Lung.
  • CareDx is in the process of seeking judicial review of January 2024 jury decision and monetary damages related to alleged infringement of patent ‘544.

“In 2023, we met our challenges head-on as we navigated the impact of Medicare coverage changes. We reset our operations, strategically reduced our cost structure, and created a growth pathway for the company in the second half of the year, as we continued to focus on care for transplant patients,” said Alex Johnson, President of Patient and Testing Services, and a member of the Office of the CEO at CareDx. “Looking forward to 2024, we are focused on delivering high-value clinical and digital solutions to improve allograft survival, while generating evidence for expanding payer coverage and accelerating our path back to profitability.”

Q4 2023 Financial Results

Revenue for the three months ended December 31, 2023, was $65.6 million, a decrease of 20% compared with $82.4 million for the fourth quarter of 2022. Testing Services revenue for the fourth quarter 2023 was $46.7 million, a decrease of 29% compared with $65.4 million in the same period in 2022. Testing Services revenue was negatively impacted due to the Medicare Billing Article changes.

Total AlloSure and AlloMap patient results provided in the fourth quarter 2023 were approximately 39,900, a decrease of 16% as compared to the same quarter a year ago, and an increase of 4% compared to the third quarter of 2023. Patient and Digital Solutions revenue for the fourth quarter 2023 was $9.6 million, compared to $8.4 million in the same period in 2022, an increase of 14%. Product revenue for the fourth quarter 2023 was $9.2 million, compared to $8.6 million in the same period in 2022, an increase of 8%.

For the fourth quarter of 2023, net loss was $118.1 million, including $96.3 million accrual associated with damages related to alleged infringement of patent ‘544, compared to a net loss of $18.3 million in the fourth quarter of 2022. Basic and diluted net loss per share in the fourth quarter of 2023 was $2.21, compared to basic and diluted net loss per share of $0.34 in the fourth quarter of 2022.

Non-GAAP net loss was $9.3 million in the fourth quarter of 2023, compared to a non-GAAP net loss of $3.7 million in the fourth quarter of 2022. Basic and diluted non-GAAP net loss per share was $0.17 in the fourth quarter of 2023, compared to a basic and diluted non-GAAP net loss per share of $0.07 in the fourth quarter of 2022.

Adjusted EBITDA for the fourth quarter of 2023 was a loss of $10.3 million, compared to an adjusted EBITDA loss of $3.7 million in the fourth quarter of 2022.

Full Year 2023 Financial Results

Total revenue for the full year ended December 31, 2023, was $280.3 million, a decrease of 13% compared with $321.8 million in 2022. Testing Services revenue for the full year 2023 was $209.7 million, compared with $263.7 million in 2022, a decrease of 20%. Patient and Digital Solutions revenue for the full year 2023 was $37.1 million, compared to $28.8 million in 2022, an increase of 29%. Product revenue for the full year 2023 was $33.5 million, compared to $29.3 million in 2022, an increase of 15%.

Net loss for the full year 2023 was $190.3 million, including $96.3 million accrual associated with damages related to alleged infringement of patent ‘544, compared to a net loss of $76.6 million in 2022. Basic and diluted net loss per share for the full year 2023 was $3.54, compared to basic and diluted net loss per share of $1.44 in the full year 2022.

Non-GAAP net loss was $34.5 million for the full year 2023, compared to a non-GAAP net loss of $20.9 million for the full year ended 2022. Basic and diluted non-GAAP net loss per share was $0.64 in the full year of 2023, compared to a basic and diluted non-GAAP net loss per share of $0.39 in the full year of 2022.

Adjusted EBITDA for the full year of 2023 was a loss of $38.0 million, compared to an adjusted EBITDA loss of $17.5 million for the full year of 2022.

Cash and cash equivalents and marketable securities were $235.4 million as of December 31, 2023. Reduced cash used in operations from $25.2 million in 2022 to $18.4 million in 2023.

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,” “Reconciliation of GAAP to Non-GAAP Gross Profit and Gross Margin,” and “Reconciliation of Non-GAAP to Adjusted EBITDA Financial Measures” below.

2024 Guidance

For the full year 2024, CareDx expects revenue to be in the range of $260 million to $274 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, CareDx’s plans to seek judicial review of jury decision and historical monetary damages on patent ‘544, 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, and global economic and marketplace uncertainties related to the COVID-19 pandemic, 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, 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 loss, non-GAAP basic and diluted net loss per share, adjusted EBITDA, and non-GAAP operating expenses.

We define non-GAAP net 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; realized gain on investments; restructuring charges and certain other charges. We define adjusted EBITDA as non-GAAP net loss before net interest income, income tax expense, depreciation and other (income) 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.

Consolidated Statements of Operations

(Unaudited)

(In thousands, except share and per share data)

 

Three Months Ended December 31,

Twelve Months Ended December 31,

2023

2022

2023

2022

Revenue:

Testing services revenue

$

46,703

$

65,418

$

209,685

$

263,748

Product revenue

9,244

8,555

33,517

29,251

Patient and digital solutions

9,622

8,411

37,122

28,794

Total revenue

65,569

82,384

280,324

321,793

Operating expenses:

Cost of testing services

13,805

18,657

57,642

72,286

Cost of product

5,637

4,617

18,379

17,639

Cost of patient and digital solutions

6,171

6,216

25,978

22,287

Research and development

18,276

23,570

81,866

90,388

Sales and marketing

19,999

23,668

83,334

96,027

General and administrative

26,541

24,776

117,868

100,397

Restructuring costs

1,472

—

2,320

—

Litigation expense

96,300

—

96,300

—

Total operating expenses

188,201

101,504

483,687

399,024

Loss from operations

(122,632

)

(19,120

)

(203,363

)

(77,231

)

Other income (expense):

Interest income, net

3,159

1,870

11,867

3,762

Change in estimated fair value of common stock warrant liability

—

18

10

107

Other income (expense), net

1,541

(924

)

1,343

(2,872

)

Total other income

4,700

964

13,220

997

Loss before income taxes

(117,932

)

(18,156

)

(190,143

)

(76,234

)

Income tax expense

(165

)

(173

)

(141

)

(379

)

Net loss

$

(118,097

)

$

(18,329

)

$

(190,284

)

$

(76,613

)

Net loss per share:

Basic

$

(2.21

)

$

(0.34

)

$

(3.54

)

$

(1.44

)

Diluted

$

(2.21

)

$

(0.34

)

$

(3.54

)

$

(1.44

)

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

Basic

53,388,830

53,524,637

53,764,705

53,321,625

Diluted

53,388,830

53,524,637

53,764,705

53,321,625

CareDx, Inc.

Consolidated Balance Sheets

(In thousands)

 

As of December 31,

2023

2022

Assets

Current assets:

Cash and cash equivalents

$

82,197

$

89,921

Marketable securities

153,221

203,168

Accounts receivable

51,061

66,312

Inventory

19,471

19,232

Prepaid and other current assets

7,763

9,216

Total current assets

313,713

387,849

Property and equipment, net

35,246

35,529

Operating leases right-of-use assets

29,891

34,689

Intangible assets, net

45,701

43,051

Goodwill

40,336

37,523

Restricted cash

586

522

Other assets

1,353

3,828

Total assets

$

466,826

$

542,991

Liabilities and stockholders’ equity

Current liabilities:

Accounts payable

$

12,872

$

9,942

Accrued compensation

19,703

16,902

Accrued and other liabilities

45,497

49,131

Total current liabilities

78,072

75,975

Deferred tax liability

136

—

Common stock warrant liability

—

32

Deferred payments for intangible assets

2,461

2,418

Operating lease liability, less current portion

28,278

33,406

Other liabilities

96,551

249

Total liabilities

205,498

112,080

Commitments and contingencies

Stockholders’ equity:

Common stock

49

52

Additional paid-in capital

946,511

898,806

Accumulated other comprehensive loss

(6,963

)

(7,503

)

Accumulated deficit

(678,269

)

(460,444

)

Total stockholders’ equity

261,328

430,911

Total liabilities and stockholders’ equity

$

466,826

$

542,991

CareDx, Inc.

Reconciliation of GAAP to Non-GAAP Financial Measures

(Unaudited)

(In thousands)

 

Three Months Ended December 31,

Twelve Months Ended December 31,

2023

2022

2023

2022

Cost of testing services reconciliation:

GAAP cost of testing services

$

13,805

$

18,657

$

57,642

$

72,286

Stock-based compensation expense

(387

)

(474

)

(1,854

)

(1,529

)

Acquisition related-amortization of purchased intangibles

(329

)

(329

)

(1,316

)

(1,316

)

Non-GAAP cost of testing services

$

13,089

$

17,854

$

54,472

$

69,441

Cost of product reconciliation:

GAAP cost of product

$

5,750

$

4,617

$

18,492

$

17,639

Stock-based compensation expense

(230

)

(269

)

(1,165

)

(1,120

)

Acquisition related-amortization of purchased intangibles

(413

)

(411

)

(1,655

)

(1,716

)

Restructuring costs

(113

)

—

(113

)

—

Non-GAAP cost of product

$

4,994

$

3,937

$

15,559

$

14,803

Cost of patient and digital solutions reconciliation:

GAAP cost of patient and digital solutions

$

6,226

$

6,216

$

26,047

$

22,287

Stock-based compensation expense

(311

)

(449

)

(1,377

)

(1,331

)

Acquisition related-amortization of purchased intangibles

(271

)

(236

)

(1,039

)

(945

)

Restructuring costs

(55

)

—

(69

)

—

Non-GAAP cost of patient and digital solutions

$

5,589

$

5,531

$

23,562

$

20,011

Research and development expenses reconciliation:

GAAP research and development expenses

$

18,617

$

23,570

$

82,452

$

90,388

Stock-based compensation expense

(1,399

)

(820

)

(6,556

)

(7,391

)

Asset impairments and write-downs

—

—

—

(340

)

Restructuring costs

(341

)

—

(586

)

—

Non-GAAP research and development expenses

$

16,877

$

22,750

$

75,310

$

82,657

Sales and marketing expenses reconciliation:

GAAP sales and marketing expenses

$

20,254

$

23,668

$

84,137

$

96,027

Stock-based compensation expense

(2,913

)

(4,701

)

(12,470

)

(14,403

)

Acquisition related-amortization of purchased intangibles

(641

)

(550

)

(2,457

)

(2,252

)

Restructuring costs

(255

)

—

(803

)

—

Non-GAAP sales and marketing expenses

$

16,445

$

18,417

$

68,407

$

79,372

General and administrative expenses reconciliation:

GAAP general and administrative expenses

$

123,549

$

24,776

$

214,917

$

100,397

Stock-based compensation expense

(4,720

)

(5,413

)

(25,664

)

(20,779

)

Change in estimated fair value of contingent consideration

(946

)

103

(2,677

)

(727

)

Acquisition related fees and expenses

(51

)

(212

)

(589

)

(599

)

Restructuring costs

(708

)

—

(749

)

—

Litigation expense

(96,300

)

—

(96,300

)

—

Other charges

—

—

(64

)

—

Non-GAAP general and administrative expenses

$

20,824

$

19,254

$

88,874

$

78,292

Total other (expense) income reconciliation:

GAAP other expense, net

$

4,700

$

964

$

13,220

$

997

Unrealized loss on investments

—

965

1,190

1,181

Realized gain on investment

(1,468

)

—

(1,468

)

—

Investment impairment

—

—

1,000

500

Other charges (income)

—

11

(2,081

)

43

Non-GAAP other income, net

$

3,232

$

1,940

$

11,861

$

2,721

Income tax expense reconciliation:

GAAP income tax expense

$

(165

)

$

(173

)

$

(141

)

$

(379

)

Tax effect related to amortization of purchased intangibles

(99

)

(98

)

(398

)

(419

)

Non-GAAP income tax expense

$

(264

)

$

(271

)

$

(539

)

$

(798

)

CareDx, Inc.

GAAP and Non-GAAP Operating Expenses

(Unaudited)

(In thousands)

 

Three Months Ended December 31,

Twelve Months Ended December 31,

2023

2022

2023

2022

GAAP operating expenses:

Research and development

$

18,617

$

23,570

$

82,452

$

90,388

Sales and marketing

20,254

23,668

84,137

96,027

General and administrative

123,549

24,776

214,917

100,397

Total GAAP operating expenses

$

162,420

$

72,014

$

381,506

$

286,812

Non-GAAP operating expenses:

Research and development

$

16,877

$

22,750

$

75,310

$

82,657

Sales and marketing

16,445

18,417

68,407

79,372

General and administrative

20,824

19,254

88,874

78,292

Total Non-GAAP operating expenses

$

54,146

$

60,421

$

232,591

$

240,321

CareDx, Inc.

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

(Unaudited)

(In thousands, except percentages)

 

Three Months Ended December 31,

Twelve Months Ended December 31,

2023

2022

2023

2022

Total revenue

$

65,569

$

82,384

$

280,324

$

321,793

GAAP cost of sales

25,781

29,490

102,181

112,212

GAAP gross profit

39,788

52,894

178,143

209,581

Stock-based compensation expense

928

1,192

4,396

3,980

Restructuring costs

168

—

182

—

Acquisition related-amortization of purchased intangibles

1,013

976

4,010

3,977

Non-GAAP gross profit

$

41,897

$

55,062

$

186,731

$

217,538

Non-GAAP gross margin %

64

%

67

%

67

%

68

%

CareDx, Inc.

Reconciliation of GAAP to Non-GAAP Financial Measures

(Unaudited)

(In thousands, except share and per share data)

 

Three Months Ended December 31,

Twelve Months Ended December 31,

2023

2022

2023

2022

GAAP net loss

$

(118,097

)

$

(18,329

)

$

(190,284

)

$

(76,613

)

Stock-based compensation expense

9,960

12,126

49,086

46,553

Unrealized loss on investments

—

965

1,190

1,181

Realized gain on investments

(1,468

)

—

(1,468

)

—

Acquisition related-amortization of purchased intangibles

1,654

1,526

6,467

6,229

Acquisition related fees and expenses

51

212

589

599

Change in estimated fair value of contingent consideration

946

(103

)

2,677

727

Tax effect related to amortization of purchased intangibles

(99

)

(98

)

(398

)

(419

)

Asset impairments and write-downs

—

—

1,000

840

Litigation expense

96,300

—

96,300

—

Restructuring costs

1,472

—

2,320

—

Other charges

—

11

(2,017

)

43

Non-GAAP net loss

$

(9,281

)

$

(3,690

)

$

(34,538

)

$

(20,860

)

GAAP basic and diluted net loss per share

$

(2.21

)

$

(0.34

)

$

(3.54

)

$

(1.44

)

Non-GAAP basic net loss per share

$

(0.17

)

$

(0.07

)

$

(0.64

)

$

(0.39

)

Non-GAAP diluted net loss per share

$

(0.17

)

$

(0.07

)

$

(0.64

)

$

(0.39

)

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

53,388,830

53,524,637

53,764,705

53,321,625

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

53,388,830

53,524,637

53,764,705

53,321,625

CareDx, Inc.

Reconciliation of Non-GAAP to Adjusted EBITDA Financial Measures

(Unaudited)

(In thousands)

 

Three Months Ended December 31,

Twelve Months Ended December 31,

2023

2022

2023

2022

Non-GAAP net loss

$

(9,281

)

$

(3,690

)

$

(34,538

)

$

(20,860

)

Interest income

(3,159

)

(1,870

)

(11,867

)

(3,762

)

Income tax expense

264

272

539

798

Depreciation expense

1,978

1,682

7,882

5,248

Other (income) expense, net

(72

)

(70

)

7

1,041

Adjusted EBITDA

$

(10,270

)

$

(3,676

)

$

(37,977

)

$

(17,535

)

CareDx, Inc. Media Relations Anna Czene 818-731-2203 aczene@caredx.com

Investor Relations Greg Chodaczek investor@CareDx.com

Source: CareDx, Inc.