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CareDx Reports Third Quarter 2023 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 third quarter ended September 30, 2023.

Third Quarter 2023 Highlights

  • Reported revenue of $67.2 million, an increase of 7% over the second quarter of 2023, excluding approximately $7.8 million related to Medicare claims billing that were held over from the first quarter of 2023 and recognized in second quarter 2023 revenue.
  • Grew Testing Services patient results to 38,400, an increase of 2% compared to the second quarter of 2023.
  • Achieved revenue of $9.9 million for Digital Solutions and $9.5 million for Products, representing year-over-year growth of 33% for both businesses.
  • Achieved the fourth consecutive quarter of collections at over 100% of revenue for Testing Services; collected over $22 million in incremental cash in the past four quarters.
  • Maintained a strong balance sheet, with $268.2 million in cash and cash equivalents, and marketable securities, with no debt.
  • Received Medicare coverage for HeartCare™ and AlloSure® Lung.
  • Raised revenue guidance to $274 to $278 million for the full year 2023.
  • SEC has concluded its inquiry and does not intend to recommend an enforcement action against the Company.

“CareDx continues to be well-placed in the transplant market. We are pleased to see a baseline being set in the Testing Services business in Q3 as patient testing volumes appear to have stabilized,” said Alex Johnson, President of Patient and Testing Services, and member of the Office of the CEO at CareDx. “We remain committed to bringing high impact innovation to the transplant clinic, while accelerating our path back to profitability.”

Third Quarter 2023 Financial Results

Revenue for the three months ended September 30, 2023, was $67.2 million, a decrease of 15% compared with $79.4 million in the third quarter of 2022, and an increase of 7% compared with $62.5 million in the second quarter of 2023, excluding approximately $7.8 million related to Medicare claims billing that were held over from the first quarter of 2023 and recognized in second quarter 2023 revenue. Testing services revenue for the quarter was $47.8 million, compared with $64.8 million in the same period in 2022.

Approximately 38,400 AlloSure® and AlloMap® patient results were provided in the quarter, representing a decrease of 18% as compared to the same quarter a year ago, and an increase of 2% compared to the second quarter of 2023.

For the third quarter of 2023, net loss was $23.5 million, compared to a net loss of $16.9 million in the same period of 2022. Basic and diluted net loss per share in the third quarter of 2023 was $0.43, compared to basic and diluted net loss per share of $0.32 in the third quarter of 2022.

Non-GAAP net loss was $9.6 million in the third quarter of 2023, compared to a non-GAAP net loss of $3.4 million in the third quarter of 2022. Basic and diluted non-GAAP net loss per share was $0.18 in the third quarter of 2023, compared to a basic and diluted non-GAAP net loss per share of $0.06 in the third quarter of 2022.

Adjusted EBITDA for the third quarter of 2023 was a loss of $10.9 million, compared to an adjusted EBITDA loss of $2.5 million in the third quarter of 2022.

Cash and cash equivalents and marketable securities were $268.2 million as of September 30, 2023.

2023 Guidance

For the full year 2023, CareDx expects revenue to be in the range of $274 to $278 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 statements regarding CareDx’s 2023 revenue expectations and the company’s path towards growth. All statements other than statements of historical fact contained in this press release, including statements regarding the future financial position of CareDx, including financial expectations, 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, 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 filed by CareDx with the SEC on February 27, 2023, the quarterly report on Form 10-Q for the quarter ended March 31, 2023 filed by CareDx with the SEC on May 10, 2023, the quarterly report on Form 10-Q for the quarter ended June 30, 2023 filed by CareDx with the SEC on August 8, 2023, and the quarterly report on Form 10-Q for the quarter ended September 30, 2023 to be filed by CareDx with the SEC on or about November 8, 2023 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, normalized revenue after adjustment of Impacted March Tests (As defined below¹), normalized revenue for testing services after adjustment of Impacted March Tests, normalized non-GAAP gross margin for testing services after adjustment of Impacted March Tests, and normalized EBITDA after adjustment of Impacted March Tests.

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; restructuring charges and certain other charges.

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

¹ Impacted March Tests represent $7.8 million related to Medicare claims billing that were held over from the first quarter of 2023 and recognized in second quarter 2023 revenue.

CareDx, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

(In thousands, except share and per share data)

 

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

2023

 

2022

 

2023

 

2022

Revenue:

 

 

 

 

 

 

 

Testing services revenue

$

47,784

 

 

$

64,751

 

 

$

162,982

 

 

$

198,330

 

Product revenue

 

9,536

 

 

 

7,194

 

 

 

24,273

 

 

 

20,696

 

Patient and digital solutions revenue

 

9,872

 

 

 

7,414

 

 

 

27,500

 

 

 

20,383

 

Total revenue

 

67,192

 

 

 

79,359

 

 

 

214,755

 

 

 

239,409

 

Operating expenses:

 

 

 

 

 

 

 

Cost of testing services

 

13,217

 

 

 

17,771

 

 

 

43,837

 

 

 

53,629

 

Cost of product

 

4,750

 

 

 

4,736

 

 

 

12,742

 

 

 

13,022

 

Cost of patient and digital solutions

 

6,566

 

 

 

5,794

 

 

 

19,807

 

 

 

16,071

 

Research and development

 

19,000

 

 

 

22,306

 

 

 

63,590

 

 

 

66,818

 

Sales and marketing

 

18,474

 

 

 

22,261

 

 

 

63,335

 

 

 

72,359

 

General and administrative

 

33,968

 

 

 

23,830

 

 

 

91,327

 

 

 

75,621

 

Restructuring costs

 

 

 

 

 

 

 

848

 

 

 

 

Total operating expenses

 

95,975

 

 

 

96,698

 

 

 

295,486

 

 

 

297,520

 

Loss from operations

 

(28,783

)

 

 

(17,339

)

 

 

(80,731

)

 

 

(58,111

)

Other income (expense):

 

 

 

 

 

 

 

Interest income, net

 

3,171

 

 

 

1,225

 

 

 

8,708

 

 

 

1,892

 

Change in estimated fair value of common stock warrant liability

 

 

 

 

14

 

 

 

10

 

 

 

89

 

Other income (expense), net

 

2,047

 

 

 

(572

)

 

 

(198

)

 

 

(1,948

)

Total other income

 

5,218

 

 

 

667

 

 

 

8,520

 

 

 

33

 

Loss before income taxes

 

(23,565

)

 

 

(16,672

)

 

 

(72,211

)

 

 

(58,078

)

Income tax benefit (expense)

 

80

 

 

 

(267

)

 

 

24

 

 

 

(206

)

Net loss

$

(23,485

)

 

$

(16,939

)

 

$

(72,187

)

 

$

(58,284

)

Net loss per share:

 

 

 

 

 

 

 

Basic

$

(0.43

)

 

$

(0.32

)

 

$

(1.34

)

 

$

(1.09

)

Diluted

$

(0.43

)

 

$

(0.32

)

 

$

(1.34

)

 

$

(1.09

)

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

 

 

 

 

 

 

 

Basic

 

54,178,759

 

 

 

53,489,418

 

 

 

53,891,374

 

 

 

53,253,210

 

Diluted

 

54,178,759

 

 

 

53,489,418

 

 

 

53,891,374

 

 

 

53,253,210

 

CareDx, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands)

 

 

September 30, 2023

 

December 31, 2022

Assets

 

 

 

Current assets:

 

 

 

Cash and cash equivalents

$

75,980

 

 

$

89,921

 

Marketable securities

 

192,204

 

 

 

203,168

 

Accounts receivable

 

51,694

 

 

 

66,312

 

Inventory

 

17,978

 

 

 

19,232

 

Prepaid and other current assets

 

7,310

 

 

 

9,216

 

Total current assets

 

345,166

 

 

 

387,849

 

Property and equipment, net

 

35,355

 

 

 

35,529

 

Operating leases right-of-use assets

 

30,973

 

 

 

34,689

 

Intangible assets, net

 

46,455

 

 

 

43,051

 

Goodwill

 

40,208

 

 

 

37,523

 

Restricted cash

 

582

 

 

 

522

 

Other assets

 

2,441

 

 

 

3,828

 

Total assets

$

501,180

 

 

$

542,991

 

Liabilities and stockholders’ equity

 

 

 

Current liabilities:

 

 

 

Accounts payable

$

8,972

 

 

$

9,942

 

Accrued compensation

 

16,664

 

 

 

16,902

 

Accrued and other liabilities

 

47,038

 

 

 

49,131

 

Total current liabilities

 

72,674

 

 

 

75,975

 

Deferred tax liability

 

140

 

 

 

 

Common stock warrant liability

 

 

 

 

32

 

Deferred payments for intangible assets

 

4,735

 

 

 

2,418

 

Operating lease liability, less current portion

 

29,252

 

 

 

33,406

 

Other liabilities

 

245

 

 

 

249

 

Total liabilities

 

107,046

 

 

 

112,080

 

Commitments and contingencies

 

 

 

Stockholders’ equity:

 

 

 

Common stock

 

52

 

 

 

52

 

Additional paid-in capital

 

936,954

 

 

 

898,806

 

Accumulated other comprehensive loss

 

(8,670

)

 

 

(7,503

)

Accumulated deficit

 

(534,202

)

 

 

(460,444

)

Total stockholders’ equity

 

394,134

 

 

 

430,911

 

Total liabilities and stockholders’ equity

$

501,180

 

 

$

542,991

 

CareDx, Inc.

Reconciliation of GAAP to Non-GAAP Financial Measures

(Unaudited)

(In thousands)

 

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

2023

 

2022

 

2023

 

2022

Cost of testing services reconciliation:

 

 

 

 

 

 

 

GAAP cost of testing services

$

13,217

 

 

$

17,771

 

 

$

43,837

 

 

$

53,629

 

Stock-based compensation expense

 

(496

)

 

 

(470

)

 

 

(1,467

)

 

 

(1,055

)

Acquisition related-amortization of purchased intangibles

 

(329

)

 

 

(329

)

 

 

(987

)

 

 

(987

)

Non-GAAP cost of testing services

$

12,392

 

 

$

16,972

 

 

$

41,383

 

 

$

51,587

 

Cost of product reconciliation:

 

 

 

 

 

 

 

GAAP cost of product

$

4,750

 

 

$

4,736

 

 

$

12,742

 

 

$

13,022

 

Stock-based compensation expense

 

(301

)

 

 

(321

)

 

 

(935

)

 

 

(851

)

Acquisition related-amortization of purchased intangibles

 

(408

)

 

 

(416

)

 

 

(1,242

)

 

 

(1,305

)

Non-GAAP cost of product

$

4,041

 

 

$

3,999

 

 

$

10,565

 

 

$

10,866

 

Cost of patient and digital solutions reconciliation:

 

 

 

 

 

 

 

GAAP cost of patient and digital solutions

$

6,566

 

 

$

5,794

 

 

$

19,821

 

 

$

16,071

 

Stock-based compensation expense

 

(297

)

 

 

(299

)

 

 

(1,066

)

 

 

(882

)

Acquisition related-amortization of purchased intangibles

 

(265

)

 

 

(236

)

 

 

(768

)

 

 

(709

)

Restructuring costs

 

 

 

 

 

 

 

(14

)

 

 

 

Non-GAAP cost of patient and digital solutions

$

6,004

 

 

$

5,259

 

 

$

17,973

 

 

$

14,480

 

Research and development expenses reconciliation:

 

 

 

 

 

 

 

GAAP research and development expenses

$

19,000

 

 

$

22,306

 

 

$

63,835

 

 

$

66,818

 

Stock-based compensation expense

 

(1,491

)

 

 

(2,058

)

 

 

(5,157

)

 

 

(6,571

)

Asset impairments and write-downs

 

 

 

 

(340

)

 

 

 

 

 

(340

)

Restructuring costs

 

 

 

 

 

 

 

(245

)

 

 

 

Non-GAAP research and development expenses

$

17,509

 

 

$

19,908

 

 

$

58,433

 

 

$

59,907

 

Sales and marketing expenses reconciliation:

 

 

 

 

 

 

 

GAAP sales and marketing expenses

$

18,474

 

 

$

22,261

 

 

$

63,883

 

 

$

72,359

 

Stock-based compensation expense

 

(3,041

)

 

 

(2,672

)

 

 

(9,557

)

 

 

(9,702

)

Acquisition related-amortization of purchased intangibles

 

(616

)

 

 

(553

)

 

 

(1,817

)

 

 

(1,702

)

Restructuring costs

 

 

 

 

 

 

 

(548

)

 

 

 

Non-GAAP sales and marketing expenses

$

14,817

 

 

$

19,036

 

 

$

51,961

 

 

$

60,955

 

General and administrative expenses reconciliation:

 

 

 

 

 

 

 

GAAP general and administrative expenses

$

33,968

 

 

$

23,830

 

 

$

91,368

 

 

$

75,621

 

Stock-based compensation expense

 

(7,045

)

 

 

(5,380

)

 

 

(20,943

)

 

 

(15,366

)

Change in estimated fair value of contingent consideration

 

(1,243

)

 

 

(266

)

 

 

(1,731

)

 

 

(830

)

Acquisition related fees and expenses

 

(253

)

 

 

(58

)

 

 

(537

)

 

 

(387

)

Restructuring costs

 

 

 

 

 

 

 

(41

)

 

 

 

Other charges

 

(6

)

 

 

 

 

 

(64

)

 

 

 

Non-GAAP general and administrative expenses

$

25,421

 

 

$

18,126

 

 

$

68,052

 

 

$

59,038

 

Total other income (expense) reconciliation:

 

 

 

 

 

 

 

GAAP other income, net

$

5,218

 

 

$

667

 

 

$

8,520

 

 

$

33

 

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

 

333

 

 

 

(271

)

 

 

1,190

 

 

 

215

 

Asset impairments and write-downs

 

 

 

 

500

 

 

 

1,000

 

 

 

500

 

Other (income) charges

 

(2,109

)

 

 

14

 

 

 

(2,081

)

 

 

32

 

Non-GAAP other income, net

$

3,442

 

 

$

910

 

 

$

8,629

 

 

$

780

 

Income tax benefit (expense) reconciliation:

 

 

 

 

 

 

 

GAAP income tax benefit (expense)

$

80

 

 

$

(267

)

 

$

24

 

 

$

(206

)

Tax effect related to amortization of purchased intangibles

 

(98

)

 

 

(101

)

 

 

(299

)

 

 

(321

)

Non-GAAP income tax expense

$

(18

)

 

$

(368

)

 

$

(275

)

 

$

(527

)

CareDx, Inc.

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

(Unaudited)

(In thousands, except percentages)

 

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

2023

 

2022

 

2023

 

2022

Total revenue

$

67,192

 

 

$

79,359

 

 

$

214,755

 

 

$

239,409

 

GAAP cost of sales

 

24,533

 

 

 

28,301

 

 

 

76,400

 

 

 

82,722

 

GAAP gross profit

 

42,659

 

 

 

51,058

 

 

 

138,355

 

 

 

156,687

 

Stock-based compensation expense

 

1,094

 

 

 

1,090

 

 

 

3,468

 

 

 

2,788

 

Restructuring costs

 

 

 

 

 

 

 

14

 

 

 

 

Acquisition related-amortization of purchased intangibles

 

1,002

 

 

 

981

 

 

 

2,997

 

 

 

3,001

 

Non-GAAP gross profit

$

44,755

 

 

$

53,129

 

 

$

144,834

 

 

$

162,476

 

Non-GAAP gross margin %

 

67

%

 

 

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 September 30,

 

Nine Months Ended September 30,

 

2023

 

2022

 

2023

 

2022

GAAP net loss

$

(23,485

)

 

$

(16,939

)

 

$

(72,187

)

 

$

(58,284

)

Stock-based compensation expense

 

12,671

 

 

 

11,200

 

 

 

39,125

 

 

 

34,427

 

Asset impairments and write-downs

 

 

 

 

840

 

 

 

1,000

 

 

 

840

 

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

 

333

 

 

 

(271

)

 

 

1,190

 

 

 

215

 

Acquisition related-amortization of purchased intangibles

 

1,618

 

 

 

1,534

 

 

 

4,814

 

 

 

4,702

 

Acquisition related fees and expenses

 

253

 

 

 

58

 

 

 

537

 

 

 

387

 

Change in estimated fair value of contingent consideration

 

1,243

 

 

 

266

 

 

 

1,731

 

 

 

830

 

Restructuring costs and charges

 

6

 

 

 

 

 

 

912

 

 

 

 

Tax effect related to amortization of purchased intangibles

 

(98

)

 

 

(101

)

 

 

(299

)

 

 

(321

)

Other (gains) charges

 

(2,109

)

 

 

15

 

 

 

(2,081

)

 

 

32

 

Non-GAAP net loss

$

(9,568

)

 

$

(3,398

)

 

$

(25,258

)

 

$

(17,172

)

 

 

 

 

 

 

 

 

GAAP basic and diluted net loss per share

$

(0.43

)

 

$

(0.32

)

 

$

(1.34

)

 

$

(1.09

)

 

 

 

 

 

 

 

 

Non-GAAP basic net loss per share

$

(0.18

)

 

$

(0.06

)

 

$

(0.47

)

 

$

(0.32

)

Non-GAAP diluted net loss per share

$

(0.18

)

 

$

(0.06

)

 

$

(0.47

)

 

$

(0.32

)

 

 

 

 

 

 

 

 

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

 

54,178,759

 

 

 

53,489,418

 

 

 

53,891,374

 

 

 

53,253,210

 

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

 

54,178,759

 

 

 

53,489,418

 

 

 

53,891,374

 

 

 

53,253,210

 

CareDx, Inc.

Reconciliation of Non-GAAP to Adjusted EBITDA

(Unaudited)

(In thousands)

 

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

2023

 

2022

 

2023

 

2022

Non-GAAP net loss

$

(9,568

)

 

$

(3,398

)

 

$

(25,258

)

 

$

(17,172

)

Interest income

 

(3,171

)

 

 

(1,225

)

 

 

(8,708

)

 

 

(1,892

)

Income tax (benefit) expense

 

(214

)

 

 

368

 

 

 

275

 

 

 

527

 

Depreciation expense

 

2,044

 

 

 

1,465

 

 

 

5,904

 

 

 

3,567

 

Other (income) expense, net

 

(40

)

 

 

314

 

 

 

79

 

 

 

1,112

 

Adjusted EBITDA

$

(10,949

)

 

$

(2,476

)

 

$

(27,708

)

 

$

(13,858

)

CareDx, Inc.

Reconciliation of GAAP Revenue to Normalized Revenue After Adjustment of Impacted March Tests

(Unaudited)

(In thousands)

 

 

Three Months Ended

 

June 30, 2023

 

September 30, 2023

GAAP revenue

$

70,301

 

 

$

67,192

AlloSure Kidney Medicare claims (Impacted March Tests)

 

(7,771

)

 

 

 

Normalized revenue after adjustment of Impacted March Tests

$

62,530

 

 

$

67,192

 

CareDx, Inc.

Reconciliation of GAAP Revenue for Testing Services to Normalized Revenue for Testing Services After Adjustment of Impacted March Tests and

Reconciliation of Non-GAAP Gross Margin (%) for Testing Services to Normalized Non-GAAP Gross Margin (%) for Testing Services After Adjustment of Impacted March Tests

(Unaudited)

(In thousands)

 

 

Three Months Ended

 

June 30, 2023

 

September 30, 2023

GAAP revenue

$

53,414

 

 

$

47,784

 

AlloSure Kidney Medicare claims (Impacted March Tests)

 

(7,771

)

 

 

 

Normalized revenue for testing services after adjustment of Impacted March Tests

$

45,643

 

 

$

47,784

 

 

 

 

 

Non-GAAP cost of testing services

$

14,503

 

 

$

12,392

 

 

 

 

 

Non-GAAP gross margin for testing services

 

73

%

 

 

74

%

AlloSure Kidney Medicare claims (Impacted March Tests)

 

5

%

 

 

%

Normalized non-GAAP gross margin for testing services (%) after adjustment of Impacted March Tests

 

68

%

 

 

74

%

CareDx, Inc.

Reconciliation of Adjusted EBITDA to Normalized EBITDA After Adjustment of Impacted March Tests

(Unaudited)

(In thousands)

 

 

Three Months Ended

 

June 30, 2023

 

September 30, 2023

Adjusted EBITDA

$

(10,350

)

 

$

(10,949

)

AlloSure Kidney Medicare claims (Impacted March Tests)

 

(7,771

)

 

 

 

Normalized EBITDA after adjustment of Impacted March Tests

$

(18,121

)

 

$

(10,949

)

 

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