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CareDx Reports Fourth Quarter and Full Year 2022 Results

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 fourth quarter and full year ended December 31, 2022.

Recent Highlights

  • Achieved full year revenue of $321.8 million, an increase of 9% compared with full year 2021 revenue. Highest ever Q4 revenue of $82.4 million, representing year-over-year growth of 4%.
  • Full year 2022 AlloMap® and AlloSure® testing volumes grew year-over-year by 19% to approximately 182,000 tests. Provided approximately 47,700 AlloMap and AlloSure patient results in the fourth quarter, growing 14% year-over-year. Q4 test volume included 2,300 AlloSure Lung tests.
  • Achieved highest ever cash collections in Q4 at 110% of revenue for testing services, representing an approximately 10% year-over-year increase demonstrating strong operational progress on this key initiative.
  • New International Society of Heart and Lung Transplantation (ISHLT) guidelines were published, supporting the expanded use of CareDx’s HeartCare solutions, AlloMap and now AlloSure, in routine monitoring of heart transplant patients.
  • Commenced authorized share buyback program of up to $50 million and in Q4 repurchased common stock for approximately $0.6 million. Program demonstrates Board of Directors’ and management’s confidence in the business, cash position and long-term growth opportunities.
  • Maintained strong balance sheet with $293 million cash and cash equivalents, and marketable securities, with no debt.

“In 2023 we plan to build on the 3 C’s – catalysts in the pipeline, collections improvements and coverage expansion across the portfolio. We were thrilled to see the first of the C’s make significant progress in Q4, where we achieved our highest ever collections quarter, delivering collections at 110% of testing service revenues,” said Reg Seeto, CEO and President of CareDx. “As we continue to build through the 3 C’s, we remain focused on delivering on adjusted EBITDA profitability in the first half of 2023.”

Q4 2022 Financial Results:

Revenue for the three months ended December 31, 2022 was $82.4 million, an increase of 4% compared with $79.2 million in the fourth quarter of 2021. Testing services revenue for the quarter was $65.4 million, compared with $68.7 million in the same period in 2021. Total AlloSure® and AlloMap® patient results provided in the quarter were 47,700, including 2,300 AlloSure® Lung patient results. Product revenue in the three months ended December 31, 2022 was $8.6 million, compared to $7.7 million in the same period in 2021. Patient and digital solutions revenue in the fourth quarter of 2022 was $8.4 million, compared to $2.9 million in the same period in 2021.

For the fourth quarter of 2022, net loss was $18.3 million, compared to a net loss of $16.2 million in the same period in 2021. Basic and diluted net loss per share in the fourth quarter of 2022 was $0.34, compared to basic and diluted net loss per share of $0.31 in the fourth quarter of 2021.

Non-GAAP net loss was $3.7 million in the fourth quarter of 2022, compared to a non-GAAP net loss of $1.5 million in the fourth quarter of 2021. Basic and diluted non-GAAP net loss per share was $0.07 in the fourth quarter of 2022, compared to a basic and diluted non-GAAP net loss per share of $0.03 in the fourth quarter of 2021.

Adjusted EBITDA for the fourth quarter of 2022 was a loss of $3.7 million, compared to an adjusted EBITDA loss of $1.4 million in the fourth quarter of 2021.

Cash and cash equivalents, and marketable securities was $293 million as of December 31, 2022.

Full Year 2022 Financial Results

Revenue for the full year ended December 31, 2022, was $321.8 million, an increase of 9% compared with $296.4 million in 2021. Testing services revenue for the full year ended December 31, 2022 was $263.7 million, compared with $259.3 million in 2021. Product revenue for the full year ended December 31, 2022 was $29.3 million, compared to $26.8 million in 2021. Patient and digital solutions revenue for the full year 2022 was $28.8 million, compared to $10.3 million in 2021.

Net loss for the full year ended December 31, 2022 was $76.6 million, compared to a net loss of $30.7 million in 2021. Basic and diluted net loss per share for the full year ended December 31, 2022 was $1.44, compared to basic and diluted net loss per share of $0.59 in the full year ended December 31, 2021.

Non-GAAP net loss was $20.9 million for the full year ended December 31, 2022, compared to a non-GAAP net income of $15.5 million for the full year ended December 31, 2021. Basic and diluted non-GAAP net loss per share was $0.39 in the full year of 2022, compared to a basic and diluted non-GAAP net income per share of $0.30 and $0.29, respectively, in the full year of 2021.

Adjusted EBITDA for the full year of 2022 was a loss of $17.5 million, compared to an adjusted EBITDA gain of $17.8 million for the full year of 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 Non-GAAP to Adjusted EBITDA Financial Measures” below.

2023 Guidance

For the full year 2023, CareDx expects revenue to be in the range of $328 million to $338 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 with respect to expectations regarding CareDx’s upcoming milestones, vision and 2023 revenue guidance. All statements other than statements of historical fact contained in this press release, including statements regarding the future financial position of CareDx, including financial targets, business strategy, and plans and objectives for future operations, are forward-looking statements. 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, 2022 to be filed by CareDx with the SEC on or about February 27, 2023. 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 (expense), net, non-GAAP income tax (expense) benefit, non-GAAP gross profit, non-GAAP gross margin (%), non-GAAP net (loss) income, non-GAAP basic and diluted net (loss) income per share and adjusted EBITDA. We define non-GAAP net (loss) income 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; and certain other charges. We define adjusted EBITDA as non-GAAP net (loss) income before net interest income, income tax expense (benefit), 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,

 

2022

 

2021

 

2022

 

2021

Revenue:

 

 

 

 

 

 

 

Testing services revenue

$

65,418

 

 

$

68,650

 

 

$

263,748

 

 

$

259,285

 

Product revenue

 

8,555

 

 

 

7,672

 

 

 

29,251

 

 

 

26,832

 

Patient and digital solutions

 

8,411

 

 

 

2,898

 

 

 

28,794

 

 

 

10,280

 

Total revenue

 

82,384

 

 

 

79,220

 

 

 

321,793

 

 

 

296,397

 

Operating expenses:

 

 

 

 

 

 

 

Cost of testing services

 

18,657

 

 

 

19,495

 

 

 

72,286

 

 

 

71,251

 

Cost of product

 

4,617

 

 

 

5,159

 

 

 

17,639

 

 

 

18,930

 

Cost of patient and digital solutions

 

6,216

 

 

 

2,347

 

 

 

22,287

 

 

 

7,208

 

Research and development

 

23,570

 

 

 

22,046

 

 

 

90,388

 

 

 

76,525

 

Sales and marketing

 

23,668

 

 

 

20,824

 

 

 

96,027

 

 

 

77,245

 

General and administrative

 

24,776

 

 

 

24,748

 

 

 

100,397

 

 

 

74,964

 

Total operating expenses

 

101,504

 

 

 

94,619

 

 

 

399,024

 

 

 

326,123

 

Loss from operations

 

(19,120

)

 

 

(15,399

)

 

 

(77,231

)

 

 

(29,726

)

Other income (expense):

 

 

 

 

 

 

 

Interest income, net

 

1,870

 

 

 

13

 

 

 

3,762

 

 

 

160

 

Change in estimated fair value of common stock warrant liability

 

18

 

 

 

56

 

 

 

107

 

 

 

106

 

Other expense, net

 

(924

)

 

 

(1,722

)

 

 

(2,872

)

 

 

(2,628

)

Total other income (expense)

 

964

 

 

 

(1,653

)

 

 

997

 

 

 

(2,362

)

Loss before income taxes

 

(18,156

)

 

 

(17,052

)

 

 

(76,234

)

 

 

(32,088

)

Income tax (expense) benefit

 

(173

)

 

 

901

 

 

 

(379

)

 

 

1,426

 

Net loss

$

(18,329

)

 

$

(16,151

)

 

$

(76,613

)

 

$

(30,662

)

Net loss per share:

 

 

 

 

 

 

 

Basic

$

(0.34

)

 

$

(0.31

)

 

$

(1.44

)

 

$

(0.59

)

Diluted

$

(0.34

)

 

$

(0.31

)

 

$

(1.44

)

 

$

(0.59

)

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

 

 

 

 

 

 

 

Basic

 

53,524,637

 

 

 

52,854,216

 

 

 

53,321,625

 

 

 

52,241,076

 

Diluted

 

53,524,637

 

 

 

52,854,216

 

 

 

53,321,625

 

 

 

52,241,076

 

CareDx, Inc.

Consolidated Balance Sheets

(In thousands)

 

 

As of December 31,

 

2022

 

2021

Assets

 

 

 

Current assets:

 

 

 

Cash and cash equivalents

$

89,921

 

 

$

348,485

 

Marketable securities

 

203,168

 

 

 

 

Accounts receivable

 

66,312

 

 

 

59,761

 

Inventory

 

19,232

 

 

 

17,186

 

Prepaid and other current assets

 

9,216

 

 

 

7,928

 

Total current assets

 

387,849

 

 

 

433,360

 

Property and equipment, net

 

35,529

 

 

 

22,044

 

Operating leases right-of-use assets

 

34,689

 

 

 

17,993

 

Intangible assets, net

 

43,051

 

 

 

50,195

 

Goodwill

 

37,523

 

 

 

36,983

 

Restricted cash

 

522

 

 

 

211

 

Other assets

 

3,828

 

 

 

5,835

 

Total assets

$

542,991

 

 

$

566,621

 

Liabilities and stockholders’ equity

 

 

 

Current liabilities:

 

 

 

Accounts payable

$

9,942

 

 

$

13,337

 

Accrued compensation

 

16,902

 

 

 

26,042

 

Accrued and other liabilities

 

49,131

 

 

 

37,922

 

Total current liabilities

 

75,975

 

 

 

77,301

 

Deferred tax liability

 

 

 

 

415

 

Common stock warrant liability

 

32

 

 

 

139

 

Deferred payments for intangible assets

 

2,418

 

 

 

5,041

 

Operating lease liability, less current portion

 

33,406

 

 

 

17,394

 

Other liabilities

 

249

 

 

 

455

 

Total liabilities

 

112,080

 

 

 

100,745

 

Commitments and contingencies

 

 

 

Stockholders’ equity:

 

 

 

Common stock

 

52

 

 

 

52

 

Additional paid-in capital

 

898,806

 

 

 

853,683

 

Accumulated other comprehensive loss

 

(7,503

)

 

 

(4,670

)

Accumulated deficit

 

(460,444

)

 

 

(383,189

)

Total stockholders’ equity

 

430,911

 

 

 

465,876

 

Total liabilities and stockholders’ equity

$

542,991

 

 

$

566,621

 

CareDx, Inc.

Reconciliation of GAAP to Non-GAAP Financial Measures

(Unaudited) (In thousands)

 

 

Three Months Ended December 31,

 

Twelve Months Ended December 31,

 

2022

 

2021

 

2022

 

2021

Cost of testing services reconciliation:

 

 

 

 

 

 

 

GAAP cost of testing services

$

18,657

 

 

$

19,495

 

 

$

72,286

 

 

$

71,251

 

Stock-based compensation expense

 

(474

)

 

 

(643

)

 

 

(1,529

)

 

 

(2,358

)

Acquisition related-amortization of purchased intangibles

 

(329

)

 

 

(329

)

 

 

(1,316

)

 

 

(1,316

)

Non-GAAP cost of testing services

$

17,854

 

 

$

18,523

 

 

$

69,441

 

 

$

67,577

 

Cost of product reconciliation:

 

 

 

 

 

 

 

GAAP cost of product

$

4,617

 

 

$

5,159

 

 

$

17,639

 

 

$

18,930

 

Stock-based compensation expense

 

(269

)

 

 

(133

)

 

 

(1,120

)

 

 

(579

)

Acquisition related-amortization of purchased intangibles

 

(411

)

 

 

(471

)

 

 

(1,716

)

 

 

(1,905

)

Non-GAAP cost of product

$

3,937

 

 

$

4,555

 

 

$

14,803

 

 

$

16,446

 

Cost of patient and digital solutions reconciliation:

 

 

 

 

 

 

 

GAAP cost of patient and digital solutions

$

6,216

 

 

$

2,347

 

 

$

22,287

 

 

$

7,208

 

Stock-based compensation expense

 

(449

)

 

 

(173

)

 

 

(1,331

)

 

 

(728

)

Acquisition related-amortization of purchased intangibles

 

(236

)

 

 

(226

)

 

 

(945

)

 

 

(684

)

Non-GAAP cost of patient and digital solutions

$

5,531

 

 

$

1,948

 

 

$

20,011

 

 

$

5,796

 

Research and development expenses reconciliation:

 

 

 

 

 

 

 

GAAP research and development expenses

$

23,570

 

 

$

22,046

 

 

$

90,388

 

 

$

76,525

 

Stock-based compensation expense

 

(820

)

 

 

(1,842

)

 

 

(7,391

)

 

 

(7,126

)

Asset impairments and write-downs

 

 

 

 

(2,418

)

 

 

(340

)

 

 

(2,418

)

Non-GAAP research and development expenses

$

22,750

 

 

$

17,786

 

 

$

82,657

 

 

$

66,981

 

Sales and marketing expenses reconciliation:

 

 

 

 

 

 

 

GAAP sales and marketing expenses

$

23,668

 

 

$

20,824

 

 

$

96,027

 

 

$

77,245

 

Stock-based compensation expense

 

(4,701

)

 

 

(2,743

)

 

 

(14,403

)

 

 

(10,887

)

Acquisition related-amortization of purchased intangibles

 

(550

)

 

 

(547

)

 

 

(2,252

)

 

 

(1,891

)

Non-GAAP sales and marketing expenses

$

18,417

 

 

$

17,534

 

 

$

79,372

 

 

$

64,467

 

General and administrative expenses reconciliation:

 

 

 

 

 

 

 

GAAP general and administrative expenses

$

24,776

 

 

$

24,748

 

 

$

100,397

 

 

$

74,964

 

Stock-based compensation expense

 

(5,413

)

 

 

(3,964

)

 

 

(20,779

)

 

 

(14,403

)

Change in estimated fair value of contingent consideration

 

103

 

 

 

574

 

 

 

(727

)

 

 

609

 

Acquisition related fees and expenses

 

(212

)

 

 

(262

)

 

 

(599

)

 

 

(1,127

)

Non-GAAP general and administrative expenses

$

19,254

 

 

$

21,096

 

 

$

78,292

 

 

$

60,043

 

Total other income (expense) reconciliation:

 

 

 

 

 

 

 

GAAP other income (expense), net

$

964

 

 

$

(1,653

)

 

$

997

 

 

$

(2,362

)

Unrealized loss on investments

 

965

 

 

 

1,576

 

 

 

1,181

 

 

 

1,743

 

Investment impairment

 

 

 

 

 

 

 

500

 

 

 

 

Other charges

 

11

 

 

 

(1

)

 

 

43

 

 

 

148

 

Non-GAAP other income (expense), net

$

1,940

 

 

$

(78

)

 

$

2,721

 

 

$

(471

)

Income tax (expense) benefit reconciliation:

 

 

 

 

 

 

 

GAAP income tax (expense) benefit

$

(173

)

 

$

901

 

 

$

(379

)

 

$

1,426

 

Tax effect related to amortization of purchased intangibles

 

(98

)

 

 

(120

)

 

 

(419

)

 

 

(493

)

Non-GAAP income tax (expense) benefit

$

(271

)

 

$

781

 

 

$

(798

)

 

$

933

 

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,

 

2022

 

2021

 

2022

 

2021

Total revenue

$

82,384

 

 

$

79,220

 

 

$

321,793

 

 

$

296,397

 

GAAP cost of sales

 

29,490

 

 

 

27,001

 

 

 

112,212

 

 

 

97,389

 

GAAP gross profit

 

52,894

 

 

 

52,219

 

 

 

209,581

 

 

 

199,008

 

Stock-based compensation expense

 

1,192

 

 

 

949

 

 

 

3,980

 

 

 

3,665

 

Acquisition related-amortization of purchased intangibles

 

976

 

 

 

1,026

 

 

 

3,977

 

 

 

3,905

 

Non-GAAP gross profit

$

55,062

 

 

$

54,194

 

 

$

217,538

 

 

$

206,578

 

Non-GAAP gross margin %

 

67

%

 

 

68

%

 

 

68

%

 

 

70

%

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,

 

2022

 

2021

 

2022

 

2021

GAAP net loss

$

(18,329

)

 

$

(16,151

)

 

$

(76,613

)

 

$

(30,662

)

Stock-based compensation expense

 

12,126

 

 

 

9,498

 

 

 

46,553

 

 

 

36,081

 

Unrealized loss on investments

 

965

 

 

 

1,576

 

 

 

1,181

 

 

 

1,743

 

Acquisition related-amortization of purchased intangibles

 

1,526

 

 

 

1,573

 

 

 

6,229

 

 

 

5,796

 

Acquisition related fees and expenses

 

212

 

 

 

262

 

 

 

599

 

 

 

1,127

 

Change in estimated fair value of contingent consideration

 

(103

)

 

 

(574

)

 

 

727

 

 

 

(609

)

Tax effect related to amortization of purchased intangibles

 

(98

)

 

 

(120

)

 

 

(419

)

 

 

(493

)

Asset impairments and write-downs

 

 

 

 

2,418

 

 

 

840

 

 

 

2,418

 

Other Charges

 

11

 

 

 

(1

)

 

 

43

 

 

 

148

 

Non-GAAP net (loss) income

$

(3,690

)

 

$

(1,519

)

 

$

(20,860

)

 

$

15,549

 

 

 

 

 

 

 

 

 

GAAP basic and diluted net loss per share

$

(0.34

)

 

$

(0.31

)

 

$

(1.44

)

 

$

(0.59

)

 

 

 

 

 

 

 

 

Non-GAAP basic net (loss) income per share

$

(0.07

)

 

$

(0.03

)

 

$

(0.39

)

 

$

0.30

 

Non-GAAP diluted net (loss) income per share

$

(0.07

)

 

$

(0.03

)

 

$

(0.39

)

 

$

0.29

 

 

 

 

 

 

 

 

 

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

 

53,524,637

 

 

 

52,854,216

 

 

 

53,321,625

 

 

 

52,241,076

 

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

 

53,524,637

 

 

 

52,854,216

 

 

 

53,321,625

 

 

 

54,410,979

 

CareDx, Inc.

Reconciliation of Non-GAAP to Adjusted EBITDA Financial Measures

(Unaudited)

(In thousands)

 

 

Three Months Ended December 31,

 

Twelve Months Ended December 31,

 

2022

 

2021

 

2022

 

2021

Non-GAAP net (loss) income

$

(3,690

)

 

$

(1,519

)

 

$

(20,860

)

 

$

15,549

 

Interest income

 

(1,870

)

 

 

(13

)

 

 

(3,762

)

 

 

(160

)

Income tax expense (benefit)

 

272

 

 

 

(781

)

 

 

798

 

 

 

(933

)

Depreciation expense

 

1,682

 

 

 

860

 

 

 

5,248

 

 

 

2,739

 

Other (income) expense, net

 

(70

)

 

 

95

 

 

 

1,041

 

 

 

632

 

Adjusted EBITDA

$

(3,676

)

 

$

(1,358

)

 

$

(17,535

)

 

$

17,827

 

 

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