Raises 2024 Revenue Guidance to $274 to $282 Million

CareDx, Inc. (Nasdaq: CDNA) – today reported financial results for the first quarter ended March 31, 2024.

First Quarter 2024 Highlights

  • Reported first quarter revenue of $72.0 million.
  • Revenue for Testing Services of $53.8 million, an increase of 15% as compared to the fourth quarter 2023.
  • Grew testing services patients results for the third consecutive quarter to approximately 42,000, an increase of 6% as compared to the fourth quarter 2023.
  • Over 30 oral presentations, posters and two symposia highlighting CareDx’s scientific advancements in heart and lung transplantation presented at the International Society for Heart and Lung Transplantation (ISHLT).
  • SHORE data presented at ISHLT demonstrated that HeartCare® multimodal testing outperforms donor-derived cell-free DNA (dd-cfDNA) testing alone in identifying allograft rejection.
  • Expanded payer coverage by 14 million lives nationwide.
  • Reported first quarter revenue of $9.6 million for Patient and Digital Solutions and $8.6 million for Products, representing year-over-year growth of 12% and 25%, respectively.
  • Ended the quarter with cash, cash equivalents, and marketable securities of approximately $216 million, with no debt.

“We set a new baseline in our Testing Services business in the second half of 2023 and are back to delivering sequential growth. I am pleased with the team’s strong performance across all businesses this quarter,” said John W. Hanna, CareDx President and CEO. “CareDx is the leader in transplant patient care and our dedication to serving patients will continue to be our catalyst for growth.”

First Quarter 2024 Financial Results

Revenue for the three months ended March 31, 2024, was $72.0 million, a decrease of 7% compared with $77.3 million for the first quarter of 2023, and an increase of 10% compared with $65.6 million in the fourth quarter of 2023. Testing Services revenue for the first quarter 2024 was $53.8 million, a decrease of 13% compared with $61.8 million in the same period in 2023, and an increase of 15% compared with $46.7 million in the fourth quarter of 2023. Testing Services revenue benefited from continued revenue cycle management initiatives including unpaid claims from test results delivered in prior quarters. These efforts added approximately $3.7 million in revenue in the first quarter.

Total AlloSure® and AlloMap® patient results provided in the first quarter 2024 were approximately 42,000, a decrease of 16% as compared to the same quarter a year ago, and an increase of 6% compared to the fourth quarter of 2023. Patient and Digital Solutions revenue for the first quarter 2024 was $9.6 million, compared to $8.6 million in the same period in 2023, an increase of 12%. Product revenue for the first quarter 2024 was $8.6 million, compared to $6.9 million in the same period in 2023, an increase of 25%.

For the first quarter of 2024 net loss was $16.7 million, compared to a net loss of $23.7 million in the first quarter of 2023. Basic and diluted net loss per share in the first quarter of 2024 was $0.32, compared to basic and diluted net loss per share of $0.44 in the first quarter of 2023.

Non-GAAP net loss was $1.4 million in the first quarter of 2024, compared to a non-GAAP net loss of $5.8 million in the first quarter of 2023. Basic and diluted non-GAAP net loss per share was $0.03 in the first quarter of 2024, compared to a basic and diluted non-GAAP net loss per share of $0.11 in the first quarter of 2023.

Adjusted EBITDA for the first quarter of 2024 was a loss of $1.9 million, compared to an adjusted EBITDA loss of $6.4 million in the first quarter of 2023, and $10.3 million adjusted EBITDA loss in the fourth quarter of 2023.

CareDx delivered strong financial and operational performance in the first quarter and is raising guidance for the full year 2024 revenue which is expected to be in the range of $274 million to $282 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 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 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; 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.

CareDx, Inc.

Condensed Consolidated Statements of Operations

(Unaudited)

(In thousands, except share and per share data)

 

 

Three Months Ended March 31,

 

2024

 

2023

Revenue:

 

 

 

Testing services revenue

$

53,837

 

 

$

61,784

 

Product revenue

 

8,594

 

 

 

6,861

 

Patient and digital solutions revenue

 

9,618

 

 

 

8,617

 

Total revenue

 

72,049

 

 

 

77,262

 

Operating expenses:

 

 

 

Cost of testing services

 

13,632

 

 

 

15,296

 

Cost of product

 

5,344

 

 

 

4,066

 

Cost of patient and digital solutions

 

6,958

 

 

 

6,604

 

Research and development

 

18,711

 

 

 

24,357

 

Sales and marketing

 

19,830

 

 

 

23,231

 

General and administrative

 

26,911

 

 

 

28,032

 

Total operating expenses

 

91,386

 

 

 

101,586

 

Loss from operations

 

(19,337

)

 

 

(24,324

)

Other income:

 

 

 

Interest income, net

 

2,885

 

 

 

2,666

 

Change in estimated fair value of common stock warrant liability

 

 

 

 

7

 

Other expense, net

 

(290

)

 

 

(1,974

)

Total other income

 

2,595

 

 

 

699

 

Loss before income taxes

 

(16,742

)

 

 

(23,625

)

Income tax benefit (expense)

 

83

 

 

 

(124

)

Net loss

$

(16,659

)

 

$

(23,749

)

Net loss per share:

 

 

 

Basic

$

(0.32

)

 

$

(0.44

)

Diluted

$

(0.32

)

 

$

(0.44

)

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

 

 

 

Basic

 

51,692,358

 

 

 

53,643,216

 

Diluted

 

51,692,358

 

 

 

53,643,216

 

CareDx, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands)

 

 

March 31, 2024

 

December 31, 2023

Assets

 

 

 

Current assets:

 

 

 

Cash and cash equivalents

$

93,299

 

 

$

82,197

 

Marketable securities

 

122,622

 

 

 

153,221

 

Accounts receivable

 

60,149

 

 

 

51,061

 

Inventory

 

20,130

 

 

 

19,471

 

Prepaid and other current assets

 

6,895

 

 

 

7,763

 

Total current assets

 

303,095

 

 

 

313,713

 

Property and equipment, net

 

34,411

 

 

 

35,246

 

Operating leases right-of-use assets

 

28,591

 

 

 

29,891

 

Intangible assets, net

 

43,330

 

 

 

45,701

 

Goodwill

 

40,336

 

 

 

40,336

 

Restricted cash

 

583

 

 

 

586

 

Other assets

 

2,060

 

 

 

1,353

 

Total assets

$

452,406

 

 

$

466,826

 

Liabilities and stockholders’ equity

 

 

 

Current liabilities:

 

 

 

Accounts payable

$

9,976

 

 

$

12,872

 

Accrued compensation

 

14,565

 

 

 

19,703

 

Accrued and other liabilities

 

45,670

 

 

 

45,497

 

Total current liabilities

 

70,211

 

 

 

78,072

 

Deferred tax liability

 

43

 

 

 

136

 

Deferred payments for intangible assets

 

1,348

 

 

 

2,461

 

Operating lease liability, less current portion

 

26,893

 

 

 

28,278

 

Other liabilities

 

97,686

 

 

 

96,551

 

Total liabilities

 

196,181

 

 

 

205,498

 

Commitments and contingencies

 

 

 

Stockholders’ equity:

 

 

 

Common stock

 

49

 

 

 

49

 

Additional paid-in capital

 

959,734

 

 

 

946,511

 

Accumulated other comprehensive loss

 

(8,108

)

 

 

(6,963

)

Accumulated deficit

 

(695,450

)

 

 

(678,269

)

Total stockholders’ equity

 

256,225

 

 

 

261,328

 

Total liabilities and stockholders’ equity

$

452,406

 

 

$

466,826

 

CareDx, Inc.

Reconciliation of GAAP to Non-GAAP Financial Measures

(Unaudited)

(In thousands)

 

 

Three Months Ended March 31,

 

2024

 

2023

Cost of testing services reconciliation:

 

 

 

GAAP cost of testing services

$

13,632

 

 

$

15,296

 

Stock-based compensation expense

 

(457

)

 

 

(479

)

Acquisition related-amortization of purchased intangibles

 

(329

)

 

 

(329

)

Non-GAAP cost of testing services

$

12,846

 

 

$

14,488

 

Cost of product reconciliation:

 

 

 

GAAP cost of product

$

5,344

 

 

$

4,066

 

Stock-based compensation expense

 

(317

)

 

 

(360

)

Acquisition related-amortization of purchased intangibles

 

(420

)

 

 

(418

)

Non-GAAP cost of product

$

4,607

 

 

$

3,288

 

Cost of patient and digital solutions reconciliation:

 

 

 

GAAP cost of patient and digital solutions

$

6,958

 

 

$

6,604

 

Stock-based compensation expense

 

(372

)

 

 

(402

)

Acquisition related-amortization of purchased intangibles

 

(271

)

 

 

(248

)

Other income

 

5

 

 

 

 

Non-GAAP cost of patient and digital solutions

$

6,320

 

 

$

5,954

 

Research and development expenses reconciliation:

 

 

 

GAAP research and development expenses

$

18,711

 

 

$

24,357

 

Stock-based compensation expense

 

(1,760

)

 

 

(1,962

)

Other charges

 

(25

)

 

 

 

Non-GAAP research and development expenses

$

16,926

 

 

$

22,395

 

Sales and marketing expenses reconciliation:

 

 

 

GAAP sales and marketing expenses

$

19,830

 

 

$

23,231

 

Stock-based compensation expense

 

(3,044

)

 

 

(3,737

)

Acquisition related-amortization of purchased intangibles

 

(633

)

 

 

(595

)

Other charges

 

(8

)

 

 

 

Non-GAAP sales and marketing expenses

$

16,145

 

 

$

18,899

 

General and administrative expenses reconciliation:

 

 

 

GAAP general and administrative expenses

$

26,911

 

 

$

28,032

 

Stock-based compensation expense

 

(7,394

)

 

 

(6,814

)

Change in estimated fair value of contingent consideration

 

(319

)

 

 

(421

)

Acquisition related fees and expenses

 

(35

)

 

 

(284

)

Restructuring charges

 

 

 

 

(58

)

Other income

 

66

 

 

 

 

Non-GAAP general and administrative expenses

$

19,229

 

 

$

20,455

 

Total other income (expense) reconciliation:

 

 

 

GAAP other income, net

$

2,595

 

 

$

699

 

Unrealized loss on long-term marketable equity securities

 

 

 

 

905

 

Asset impairments and write-downs

 

 

 

 

1,000

 

Other charges

 

 

 

 

20

 

Non-GAAP other income, net

$

2,595

 

 

$

2,624

 

Income tax benefit (expense) reconciliation:

 

 

 

GAAP income tax benefit (expense)

$

83

 

 

$

(124

)

Tax effect related to amortization of purchased intangibles

 

(102

)

 

 

(101

)

Non-GAAP income tax expense

$

(19

)

 

$

(225

)

CareDx, Inc.

GAAP and Non-GAAP Operating Expenses

(Unaudited)

(In thousands)

 

 

Three Months Ended March 31,

 

2024

 

2023

GAAP operating expenses:

 

 

 

Research and development

$

18,711

 

$

24,357

Sales and marketing

 

19,830

 

 

23,231

General and administrative

 

26,911

 

 

28,032

Total GAAP operating expenses

$

65,452

 

$

75,620

 

 

 

 

Non-GAAP operating expenses:

 

 

 

Research and development

$

16,926

 

$

22,395

Sales and marketing

 

16,145

 

 

18,899

General and administrative

 

19,229

 

 

20,455

Total Non-GAAP operating expenses

$

52,300

 

$

61,749

CareDx, Inc.

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

(Unaudited)

(In thousands, except percentages)

 

 

Three Months Ended March 31,

 

2024

 

2023

Total revenue

$

72,049

 

 

$

77,262

 

GAAP cost of sales

 

25,934

 

 

 

25,966

 

GAAP gross profit

 

46,115

 

 

 

51,296

 

Stock-based compensation expense

 

1,146

 

 

 

1,241

 

Other income

 

(5

)

 

 

 

Acquisition related-amortization of purchased intangibles

 

1,020

 

 

 

995

 

Non-GAAP gross profit

$

48,276

 

 

$

53,532

 

Non-GAAP gross margin %

 

67

%

 

 

69

%

CareDx, Inc.

Reconciliation of GAAP to Non-GAAP Financial Measures

(Unaudited)

(In thousands, except share and per share data)

 

 

Three Months Ended March 31,

 

2024

 

2023

GAAP net loss

$

(16,659

)

 

$

(23,749

)

Stock-based compensation expense

 

13,344

 

 

 

13,754

 

Acquisition related-amortization of purchased intangibles

 

1,653

 

 

 

1,590

 

Acquisition related fees and expenses

 

35

 

 

 

284

 

Change in estimated fair value of contingent consideration

 

319

 

 

 

421

 

Other income and charges

 

(38

)

 

 

20

 

Tax effect related to amortization of purchased intangibles

 

(102

)

 

 

(101

)

Asset impairments and write-downs

 

 

 

 

1,000

 

Unrealized loss on long-term marketable equity securities

 

 

 

 

905

 

Restructuring charges

 

 

 

 

58

 

Non-GAAP net loss

$

(1,448

)

 

$

(5,818

)

 

 

 

 

GAAP basic and diluted net loss per share

$

(0.32

)

 

$

(0.44

)

 

 

 

 

Non-GAAP basic net loss per share

$

(0.03

)

 

$

(0.11

)

Non-GAAP diluted net loss per share

$

(0.03

)

 

$

(0.11

)

 

 

 

 

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

 

51,692,358

 

 

 

53,643,216

 

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

 

51,692,358

 

 

 

53,643,216

 

CareDx, Inc.

Reconciliation of Non-GAAP to Adjusted EBITDA

(Unaudited)

(In thousands)

 

 

Three Months Ended March 31,

 

2024

 

2023

Non-GAAP net loss

$

(1,448

)

 

$

(5,818

)

Interest income

 

(2,885

)

 

 

(2,666

)

Income tax expense

 

19

 

 

 

225

 

Depreciation expense

 

2,168

 

 

 

1,808

 

Other expense, net

 

290

 

 

 

36

 

Adjusted EBITDA

 

(1,856

)

 

 

(6,415

)

Unrecognized AlloSure Kidney Medicare claims

 

 

 

 

8,912

 

Adjusted EBITDA assuming recognition of paused claims

$

(1,856

)

 

$

2,497

 

 

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

Investor Relations Greg Chodaczek investor@caredx.com

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