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CareDx Reports Fourth Quarter and Full Year 2022 Results

February 27, 2023 4:01 PM

BRISBANE, Calif.--(BUSINESS WIRE)-- 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

“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

CareDx, Inc.

Media Relations

Anna Czene

818-731-2203

[email protected]

Investor Relations

Greg Chodaczek

[email protected]

Source: CareDx, Inc.

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