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Veracyte Announces Fourth Quarter and Full-Year 2023 Financial Results

VCYT

Grew Fourth Quarter Revenue to $98.2 million

Increased 2023 Total Revenue 22% to $361.1 million

Conference Call and Webcast Today at 4:30 p.m. ET

Veracyte, Inc. (Nasdaq: VCYT) today announced financial results for the fourth quarter and full year ended December 31, 2023.

“We closed 2023 with another quarter of excellent results, driven by our Afirma and Decipher businesses,” said Marc Stapley, Veracyte’s chief executive officer. “Looking to 2024 and beyond, we will leverage our Veracyte Diagnostics Platform to continue to drive near- and long-term revenue. With multiple growth catalysts over the coming years and with our strong financial discipline, we expect to achieve positive cash flow for the third consecutive year and going forward.”

Key Business Highlights

  • Grew total test volume to 33,836 in the fourth quarter and 126,977 for the full year 2023, an increase of 21% and 24%, respectively, compared to the prior year periods.
  • Enhanced our Endocrinology offering in 2023 with the launch of TERT promoter mutation testing for Afirma, the introduction of our Afirma GRID research tool, and enhancements to our online physician ordering portal.
  • Continued to strengthen the body of evidence for Decipher Prostate in 2023, adding 8 publications and 16 abstracts to the clinical-evidence library, reinforcing Decipher’s status as the only molecular test to receive Level 1 evidence designation in the National Comprehensive Cancer Network’s (NCCN) prostate cancer guidelines.
  • Acquired C2i Genomics Inc., adding whole-genome minimal residual disease (MRD) capabilities to our novel Veracyte Diagnostics Platform and expanding our ability to serve patients across the cancer care continuum.
  • Signed an agreement with Illumina to develop some of our tests as in vitro diagnostics (IVDs) for use on their NextSeq 550Dx next-generation sequencing (NGS) instrument, as part of our multi-platform strategy to accelerate global expansion of our tests as IVDs.
  • Published the clinical validation study for our Percepta Nasal Swab test in CHEST.
  • For the full year, generated $44 million of cash from operations and ended the year with $216 million of cash and cash equivalents.

Fourth Quarter 2023 Financial Results

Total revenue for the fourth quarter of 2023 was $98.2 million, an increase of 22% compared to $80.3 million reported in the fourth quarter of 2022. Testing revenue was $90.4 million, an increase of 29% compared to $70.3 million in the fourth quarter of 2022, driven primarily by the strong performance of our Decipher Prostate and Afirma tests. Product revenue was $3.7 million, an increase of 13% compared to $3.2 million in the fourth quarter of 2022. Biopharmaceutical and other revenue was $4.1 million, a decrease of 39% compared to $6.8 million in the fourth quarter of 2022.

Total gross margin for the fourth quarter of 2023, including the amortization of acquired intangible assets, was 66%, compared to 61% in the fourth quarter of 2022. Non-GAAP gross margin, excluding the amortization of acquired intangible assets and other acquisition related expenses was 70%, compared to 67% in the fourth quarter of 2022.

Operating expenses, excluding cost of revenue, were $100.3 million, which included an impairment charge of $32.0 million associated with the impairment of HalioDx developed biopharmaceutical services technology, customer relationships and customer backlog finite-lived intangible assets, compared to $54.1 million in the fourth quarter of 2022. Non-GAAP operating expenses, which excludes cost of revenue, amortization of acquired intangible assets, impairment charges, other acquisition related expenses, and other restructuring costs, grew 28% to $65.6 million, including a technology access fee of $3.5 million to develop our IVD kitted tests on an NGS platform, compared to $51.1 million in the fourth quarter of 2022.

Net loss for the fourth quarter of 2023 was $28.3 million, and basic and diluted net loss per common share was $0.39, which includes the aforementioned $32.0 million impairment charge. Net cash provided by operating activities in the fourth quarter of 2023 was $15.6 million, an improvement of $5.8 million compared to the same period in 2022.

A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading “Note Regarding Use of Non-GAAP Financial Measures.”

Full Year 2023 Financial Results

Total revenue for 2023 was $361.1 million, an increase of 22% compared to $296.5 million in 2022. Testing revenue was $326.5 million, an increase of 30% compared to $250.5 million in 2022, driven primarily by the strong performance of our Decipher and Afirma tests. Product revenue was $15.6 million, an increase of 23% compared to $12.6 million in 2022. Biopharmaceutical and other revenue was $18.9 million, a decrease of 43% compared to $33.4 million in 2022, driven by the reduction of customer projects given overall spending constraints across the industry.

Total gross margin for the full year 2023, including the amortization of acquired intangible assets, was 64%, compared to 59% in 2022. Non-GAAP gross margin, excluding the amortization of acquired intangible assets and other acquisition related expenses was 69%, compared to 66% in 2022.

Operating expenses, excluding cost of revenue, were $315.5 million, an increase of 46% compared to $216.8 million in 2022. Non-GAAP operating expenses, which excludes cost of revenue, amortization of acquired intangible assets, impairment charges, other acquisition related expenses and other restructuring costs, grew 20% to $240.7 million compared to $200.3 million in 2022.

Net loss for the full year 2023 was $74.4 million and basic and diluted net loss per common share was $1.02, which includes impairment charges of $68.3 million in the year. Net cash provided by operating activities in 2023 was $44.2 million, an increase of $36.7 million compared to 2022.

A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading "Note Regarding Use of Non-GAAP Financial Measures."

2024 Financial Outlook

The company is maintaining full-year 2024 total revenue guidance of $394 million to $402 million and, consistent with prior guidance, expects cash, cash equivalents and short-term investments at the end of the year to be $230 million to $234 million.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company's financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: https://edge.media-server.com/mmc/p/tkiac6t9. The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at https://investor.veracyte.com/events-presentations.

The conference call dial-in can be accessed by registering at the following link: https://register.vevent.com/register/BI38de228ea0a04e0ab786cfe56be5ca1b

About Veracyte

Veracyte (Nasdaq: VCYT) is a global diagnostics company whose vision is to transform cancer care for patients all over the world. We empower clinicians with the high-value insights they need to guide and assure patients at pivotal moments in the race to diagnose and treat cancer. Our Veracyte Diagnostics Platform delivers high-performing cancer tests that are fueled by broad genomic and clinical data, deep bioinformatic and AI capabilities, and a powerful evidence-generation engine, which ultimately drives durable reimbursement and guideline inclusion for our tests, along with new insights to support continued innovation and pipeline development. For more information, please visit www.veracyte.com or follow us on LinkedIn or X (Twitter).

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to our statements related to our plans, objectives, and expectations (financial and otherwise), including with respect to 2024 financial and operating results; statements regarding the expected benefits of the acquisition of C2i Genomics; and our intentions with respect to our tests and products, for use in diagnosing and treating diseases, in and outside of the United States. Forward-looking statements can be identified by words such as: “appears,” “anticipate,” “intend,” “plan,” “expect,” “believe,” “should,” “may,” “will,” “enable,” “positioned,” “offers,” “designed” and similar references to future periods. Actual results may differ materially from those projected or suggested in any forward-looking statements. These statements involve risks and uncertainties, which could cause actual results to differ materially from our predictions, and include, but are not limited to: our ability to launch, commercialize and receive reimbursement for our products; our ability to execute on our business strategies relating to the C2i Genomics acquisition, integration the business and realize expected benefits and synergies; our ability to demonstrate the validity and utility of our genomic tests and biopharma and other offerings; our ability to continue executing on our business plan; our ability to continue to scale our global operations and enhance our internal control environment; the impact of the war in Ukraine and other regional conflicts on European economies and energy supply, as well as our facilities in France; the impact of foreign currency fluctuations, increasing interest rates, inflation, potential government shutdowns and turmoil in the global banking and finance system; and the performance and utility of our tests in the clinical environment. Additional factors that may impact these forward-looking statements can be found under the caption “Risk Factors” in our Annual Report on Form 10-K filed on March 1, 2023, and our Quarterly Report on Form 10-Q filed for the three months ended September 30, 2023, filed on November 8, 2023, as well as in other documents that we may file from time to time with the Securities and Exchange Commission. Copies of these documents, when available, may be found in the Investors section of our website at investor.veracyte.com. These forward-looking statements speak only as of the date hereof and, except as required by law, we specifically disclaim any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise.

Veracyte, the Veracyte logo, Decipher, C2i Genomics, and Afirma are registered trademarks of Veracyte, Inc., and its subsidiaries in the U.S. and selected countries.

Note Regarding Use of Non-GAAP Financial Measures

In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), this press release and the accompanying tables contain, and reference certain non‐GAAP results including non-GAAP gross margin, non-GAAP operating expenses, and non-GAAP loss from operations. These measures are not meant to be considered superior to or a substitute for financial measures calculated in accordance with GAAP, and investors are cautioned that there are material limitations associated with the use of non-GAAP financial measures as an analytical tool.

We use non-GAAP measures to internally evaluate and analyze financial results. We believe these non-GAAP financial measures provide investors with useful supplemental information about the financial performance of our business, enable comparison of financial results between periods where certain items may vary independent of business performance, and enable comparison of our financial results with other public companies, many of which present similar non-GAAP financial measures. However, the non-GAAP measures we present may be different from those used by other companies.

We exclude amortization of acquired intangible assets, acquisition-related expenses relating to our acquisitions of Decipher Biosciences, HalioDx and C2i Genomics, impairment charges associated with the nCounter license and other biopharmaceutical services related HalioDx intangible assets and certain costs related to restructuring from certain of our non-GAAP measures. Management has excluded the effects of these items in non-GAAP measures to help investors gain a better understanding of the core operating results and future prospects of the company, consistent with how management measures and forecasts the company's performance, especially when comparing such results to previous periods or forecasts. The company encourages investors to carefully consider its results under GAAP, as well as its supplemental non‐GAAP information and the reconciliation between these presentations, to more fully understand its business.

Reconciliations between our GAAP results and non‐GAAP financial measures are presented in the tables of this release.

VERACYTE, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

(In thousands, except share and per share amounts)

Three Months Ended December 31

Twelve Months Ended December 31

2023

2022

2023

2022

Revenues:

Testing revenue

$

90,385

$

70,269

$

326,542

$

250,544

Product revenue

3,665

3,231

15,588

12,632

Biopharmaceutical and other revenue

4,149

6,797

18,921

33,360

Total revenue

98,199

80,297

361,051

296,536

Operating expenses (1):

Cost of testing revenue

24,105

19,394

88,913

75,317

Cost of product revenue

1,753

2,618

8,666

7,820

Cost of biopharmaceutical and other revenue

3,518

4,819

15,324

18,445

Research and development

18,673

11,287

57,305

40,603

Selling and marketing

25,260

24,127

101,490

97,560

General and administrative

23,795

18,208

86,229

73,200

Impairment of long-lived assets

32,039

68,349

3,318

Intangible asset amortization

4,563

5,264

20,570

21,354

Total operating expenses

133,706

85,717

446,846

337,617

Loss from operations

(35,507

)

(5,420

)

(85,795

)

(41,081

)

Other income, net

5,035

1,979

9,183

4,654

Loss before income taxes

(30,472

)

(3,441

)

(76,612

)

(36,427

)

Income tax (benefit) provision

(2,179

)

403

(2,208

)

133

Net loss

$

(28,293

)

$

(3,844

)

$

(74,404

)

$

(36,560

)

Net loss per common share, basic and diluted

$

(0.39

)

$

(0.05

)

$

(1.02

)

$

(0.51

)

Shares used to compute net loss per common share, basic and diluted

73,107,059

71,825,754

72,644,487

71,549,204

1. Cost of revenue, research and development, sales and marketing and general and administrative expenses include the following stock-based compensation related expenses:

Three Months Ended December 31

Twelve Months Ended December 31

2023

2022

2023

2022

Cost of revenue

$

472

$

408

$

1,858

$

1,355

Research and development

1,495

1,332

5,326

6,132

Selling and marketing

2,498

1,297

9,624

6,018

General and administrative

3,142

3,997

16,681

13,951

Total stock-based compensation expense

$

7,607

$

7,034

$

33,489

$

27,456

VERACYTE, INC.

CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE LOSS

(Unaudited)

(In thousands)

Three Months Ended December 31

Twelve Months Ended December 31

2023

2022

2023

2022

Net loss

$

(28,293

)

$

(3,844

)

$

(74,404

)

$

(36,560

)

Other comprehensive income (loss):

Change in currency translation adjustments

3,765

22,720

7,328

(16,263

)

Net comprehensive loss

$

(24,528

)

$

18,876

$

(67,076

)

$

(52,823

)

VERACYTE, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

December 31,

December 31,

2023

2022

(Unaudited)

(See Note 1)

Assets

Current assets:

Cash and cash equivalents

$

216,454

$

154,247

Short-term investments

24,605

Accounts receivable

40,378

44,021

Supplies and inventory

16,128

14,294

Prepaid expenses and other current assets

12,661

11,469

Total current assets

285,621

248,636

Property, plant and equipment, net

20,584

17,702

Right-of-use assets, operating leases

10,277

13,160

Intangible assets, net

88,593

174,866

Goodwill

702,984

695,891

Restricted cash

876

749

Other assets

5,971

5,418

Total assets

$

1,114,906

$

1,156,422

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable

$

12,943

$

11,911

Accrued liabilities

38,427

37,774

Current portion of deferred revenue

2,008

2,613

Current portion of acquisition-related contingent consideration

2,657

6,060

Current portion of operating lease liabilities

5,105

4,070

Current portion of other liabilities

101

186

Total current liabilities

61,241

62,614

Deferred tax liabilities

734

4,531

Acquisition-related contingent consideration, net of current portion

518

2,498

Operating lease liabilities, net of current portion

7,525

10,648

Other liabilities

786

931

Total liabilities

70,804

81,222

Total stockholders’ equity

1,044,102

1,075,200

Total liabilities and stockholders’ equity

$

1,114,906

$

1,156,422

1. The condensed consolidated balance sheet at December 31, 2022 has been derived from the audited financial statements at that date included in the Company's Form 10-K filed with the Securities and Exchange Commission dated March 1, 2023.

VERACYTE, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(In thousands)

Twelve Months Ended December 31

2023

2022

Operating activities

Net loss

$

(74,404

)

$

(36,560

)

Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation and amortization

27,188

25,928

Loss on disposal of property and equipment

271

206

Stock-based compensation

33,141

26,734

Deferred income taxes

(3,839

)

133

Interest on end-of-term debt obligation

161

Noncash lease expense

4,158

3,320

Revaluation of acquisition-related contingent consideration

(5,383

)

154

Impairment loss

68,349

3,318

Effect of foreign currency on operations

(1,096

)

522

Changes in operating assets and liabilities:

Accounts receivable

3,887

(4,495

)

Supplies and inventory

(1,694

)

(3,011

)

Prepaid expenses and other current assets

(458

)

1,390

Other assets

(758

)

(3,049

)

Operating lease liability

(4,330

)

(3,448

)

Accounts payable

(134

)

152

Accrued liabilities and deferred revenue

(676

)

(3,920

)

Net cash provided by operating activities

44,222

7,535

Investing activities

Purchase of short-term investments

(19,700

)

(33,519

)

Proceeds from sale of short-term investments

39,773

Proceeds from maturity of short-term investments

5,000

12,681

Purchases of property, plant and equipment

(9,961

)

(8,549

)

Net cash provided by (used in) investing activities

15,112

(29,387

)

Financing activities

Payment of long-term debt

(1,281

)

Payment of taxes on vested restricted stock units

(6,741

)

(3,167

)

Proceeds from the exercise of common stock options and employee stock purchases

9,578

7,942

Net cash provided by financing activities

2,837

3,494

Increase (decrease) in cash, cash equivalents and restricted cash

62,171

(18,358

)

Effect of foreign currency on cash, cash equivalents and restricted cash

163

(592

)

Net increase (decrease) in cash, cash equivalents and restricted cash

62,334

(18,950

)

Cash, cash equivalents and restricted cash at beginning of year

154,996

173,946

Cash, cash equivalents and restricted cash at end of period

$

217,330

$

154,996

CASH, CASH EQUIVALENTS AND RESTRICTED CASH

(Unaudited)

(In thousands)

December 31,

December 31,

2023

2022

Cash and cash equivalents

$

216,454

$

154,247

Restricted cash

876

749

Total cash, cash equivalents and restricted cash

$

217,330

$

154,996

Reconciliation of U.S. GAAP to Non-GAAP Financial Measures

(Unaudited)

(In thousands)

Identified Expenses

GAAP

Acquisition Related Expenses (1)

Intangible Assets Amortization Expense

Other (4)

Total Non-GAAP Measure

Three Months Ended December 31, 2023

Total revenue

$

98,199

$

$

$

$

98,199

Cost of testing revenue

24,105

24,105

Cost of product revenue

1,753

1,753

Cost of biopharmaceutical and other revenue

3,518

3,518

Intangible asset amortization (2)

4,035

4,035

Gross margin $

64,788

4,035

68,823

Gross margin %

66

%

70

%

Research and development

18,673

18,673

Selling and marketing

25,260

294

24,966

General and administrative

23,795

1,867

21,928

Impairment of long-lived assets

32,039

32,039

Intangible asset amortization

528

528

Total operating expenses excluding cost of revenue (3)

100,295

2,161

528

32,039

65,567

Income (loss) from operations

$

(35,507

)

$

2,161

$

4,563

$

32,039

$

3,256

Three Months Ended December 31, 2022

Total revenue

$

80,297

$

$

$

$

80,297

Cost of testing revenue

19,394

50

19,344

Cost of product revenue

2,618

2,618

Cost of biopharmaceutical and other revenue

4,819

64

4,755

Intangible asset amortization (2)

4,747

4,747

Gross margin $

48,719

114

4,747

53,580

Gross margin %

61

%

67

%

Research and development

11,287

232

11,055

Selling and marketing

24,127

917

23,210

General and administrative

18,208

1,368

16,840

Impairment of long-lived assets

Intangible asset amortization

517

517

Total operating expenses excluding cost of revenue (3)

54,139

2,517

517

51,105

Income (loss) from operations

$

(5,420

)

$

2,631

$

5,264

$

$

2,475

1. Includes transaction related expenses as well as post-combination compensation expenses. For each of the three months ended December 31, 2022, and December 31, 2023, adjustments consist primarily of remeasurement of contingent consideration related to our adoption of a multi-platform IVD strategy and post-combination compensation expenses associated with the acquisition of HalioDx. For the three months ended December 31, 2023 adjustments include the transaction related expenses associated with the acquisition of C2i Genomics.

2. Includes only amortization of intangible assets identified as developed technology assets through purchase accounting transactions, which otherwise would have been allocated to cost of revenue.

3. Includes only amortization of intangible assets, which otherwise would have been allocated to research and development, selling and marketing or general and administrative expense and excludes the cost of revenue ($29.4 million and $26.8 million) and the amortization of intangible assets which would have been allocated to the cost of revenue ($4.0 million and $4.7 million) for the three months ended December 31, 2023 and for the three months ended December 31, 2022 respectively.

4. For the three months ended December 31, 2023, includes $32.0 million expense related to the impairment charge associated with HalioDx developed technology, customer relationships and customer backlog finite-lived intangible assets.

Reconciliation of U.S. GAAP to Non-GAAP Financial Measures

(Unaudited)

(In thousands)

Identified Expenses

GAAP

Acquisition Related Expenses (1)

Intangible Assets Amortization Expense

Other (4)

Total Non-GAAP Measure

Twelve Months Ended December 31, 2023

Total revenue

$

361,051

$

$

$

$

361,051

Cost of testing revenue

88,913

83

88,830

Cost of product revenue

8,666

8,666

Cost of biopharmaceutical and other revenue

15,324

94

15,230

Intangible asset amortization (2)

18,464

18,464

Gross margin $

229,684

177

18,464

248,325

Gross margin %

64

%

69

%

Research and development

57,305

58

57,247

Selling and marketing

101,490

2,610

98,880

General and administrative

86,229

329

1,371

84,529

Impairment of long-lived assets

68,349

68,349

Intangible asset amortization

2,106

2,106

Total operating expenses excluding cost of revenue (3)

315,479

2,997

2,106

69,720

240,656

Income (loss) from operations

$

(85,795

)

$

3,174

$

20,570

$

69,720

$

7,669

Twelve Months Ended December 31, 2022

Total revenue

$

296,536

$

$

$

$

296,536

Cost of testing revenue

75,317

203

18

75,096

Cost of product revenue

7,820

3

7,817

Cost of biopharmaceutical and other revenue

18,445

325

18,120

Intangible asset amortization (2)

19,273

19,273

Gross margin $

175,681

528

19,273

21

195,503

Gross margin %

59

%

66

%

Research and development

40,603

1,418

39,185

Selling and marketing

97,560

3,914

493

93,153

General and administrative

73,200

5,245

67,955

Impairment of long-lived assets

3,318

3,318

Intangible asset amortization

2,081

2,081

Total operating expenses excluding cost of revenue (3)

216,762

10,577

2,081

3,811

200,293

Loss from operations

$

(41,081

)

$

11,105

$

21,354

$

3,832

$

(4,790

)

1. Includes transaction related expenses as well as post-combination compensation expenses, adjustments consist primarily remeasurement of contingent consideration related to our adoption of a multi-platform IVD strategy, post-combination compensation expenses associated with the acquisition of HalioDx and transaction related expenses associated with the acquisition of C2i Genomics.

2. Includes only amortization of intangible assets identified as developed technology assets through purchase accounting transactions, which otherwise would have been allocated to cost of revenue.

3. Includes only amortization of intangible assets, which otherwise would have been allocated to research and development, selling and marketing or general and administrative expense and excludes the cost of revenue ($112.9 and $101.6 million) and the amortization of intangible assets which would have been allocated to the cost of revenue ($18.5 and $19.3 million) for the full year 2023 and 2022 respectively.

4. 2022 includes $3.3 million expense related to the impairment charge associated with certain developed technology intangible assets; 2023 includes $34.9 million expense related to the impairment charge associated with the nCounter license intangible assets, $32.0 million related to the impairment charge associated with HalioDx developed technology, customer relationships and customer backlog finite-lived intangible assets, $1.4 million related to the departure of the former executive chair and $1.4 million related to restructuring costs.