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Veracyte Announces Fourth Quarter and Full-Year 2020 Financial Results

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Fourth Quarter Revenue Increased 16% to $34.5 Million; Volume Grew 14% to 13,130 Tests

Decipher Acquisition to Expand Global Leadership in Cancer Genomic Diagnostics While Accelerating Growth

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, 2020 and provided an update on recent business progress.

"Our revenue and genomic testing and product volume continued to rebound from the pandemic during the fourth quarter and we entered 2021 with strong momentum across our business," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "We are on track to launch multiple new products this year, including our noninvasive nasal swab test and Percepta Genomic Atlas in lung cancer.

"Additionally, we expect our pending acquisition of Decipher Biosciences, with its market-leading products in urologic cancers, will significantly accelerate our revenue growth by expanding our reach into seven of the ten most common cancers, further solidifying our global leadership in cancer genomic diagnostics. We look forward to welcoming Decipher’s employees when the transaction closes and to strengthening our executive leadership team with the addition of Dr. Tina Nova, Decipher’s president and CEO."

Fourth Quarter 2020 Financial Results

For the three months ended December 31, 2020, compared to the prior year:

  • Total Revenue was $34.5 million, an increase of 16%;

  • Gross Margin was 68%, an increase of 2 percentage points;

  • Operating Expenses, Excluding Cost of Revenue, were $31.4 million, an increase of 13%;

  • Net Loss and Comprehensive Loss was $8.0 million, compared to $7.5 million;

  • Basic and Diluted Net Loss Per Common Share was $0.14, versus $0.15;

  • Net Cash Provided by Operating Activities was $2.3 million, compared to $1.8 million; and

  • Cash and Cash Equivalents were $349.4 million at December 31, 2020.

For the year ended December 31, 2020, compared to the prior year:

  • Total Revenue was $117.5 million, a decrease of 2%;

  • Gross Margin was 65%, a decrease of 5 percentage points;

  • Operating Expenses, Excluding Cost of Revenue, were $111.4 million, an increase of 13%;

  • Net Loss and Comprehensive Loss was $34.9 million, compared to $12.6 million;

  • Basic and Diluted Net Loss Per Common Share was $0.66, versus $0.27; and

  • Net Cash Used in Operating Activities was $9.7 million, compared to $3.2 million.

2020 Full-Year and Recent Business Highlights

Commercial Growth

  • Grew revenue to $34.5 million in the fourth quarter, an increase of 16% compared to the same period in 2019.

  • Product revenue grew to $9.8 million for 2020, exceeding our expectations.

  • Achieved genomic testing and product volume of 13,130 tests in the fourth quarter, a 14% increase compared to the fourth quarter of 2019.

  • Received new Medicare reimbursement rate of $5,500 for the Envisia Genomic Classifier, which went into effect on October 1, 2020, following the test’s designation by the Centers for Medicare & Medicaid Services as an Advanced Diagnostic Laboratory Test (ADLT).

  • Received reimbursement approval from the German government for the Prosigna® Breast Cancer Gene Signature Assay, making the test accessible for all breast cancer patients in Germany with HR+/HER2- early-stage breast cancer.

Evidence Development

  • Published ten studies in leading peer-reviewed journals supporting our genomic tests in four disease areas (lung cancer, breast cancer, thyroid cancer and interstitial lung diseases, including idiopathic pulmonary fibrosis).

  • Launched the PROCURE study, led by an independent scientific committee of breast cancer experts and including input from 180 clinicians throughout Europe, to help achieve consensus on the evidence supporting the most frequently used breast cancer genomic tests, including Prosigna.

Pipeline Advancement/Collaborations

  • Unveiled new preliminary performance data at an R&D Day event for our noninvasive nasal swab test for early lung cancer detection and our Percepta Genomic Atlas for informing treatment decisions at the time of lung cancer diagnosis.

  • Expanded our strategic collaboration with the Lung Cancer Initiative at Johnson & Johnson to include a focus on the NOBLE trial. The 9,000-patient, prospective, multicenter clinical study is designed to distinguish genomic and other differences in lung cancer development, which may fuel Veracyte’s development of future tests.

Decipher Acquisition

  • Announced we have entered into an agreement to acquire Decipher Biosciences, a commercial-stage precision oncology company focused on urologic cancers, further solidifying Veracyte’s global leadership in the genomic cancer diagnostics market while accelerating revenue growth.

  • Under terms of the acquisition agreement and following Veracyte’s exercise of an option to substitute cash for the entire stock portion of the consideration, the company will pay Decipher security holders $600 million in cash, subject to customary purchase price adjustments.

  • The acquisition is expected to close on or before April 1, 2021, subject to regulatory approval and the satisfaction of other customary conditions.

Financing

  • Issued and sold 8,547,297 shares of common stock, including 1,114,864 shares sold upon full exercise of the underwriters’ option to purchase additional shares, at a price to the public of $74.00 per share. The net proceeds to Veracyte from the offering were approximately $593.8 million.

  • Veracyte intends to use a portion of the net proceeds from the offering, together with its existing cash and cash equivalents, to finance its acquisition of Decipher and intends to use the remaining net proceeds of the offering for working capital and other general corporate purposes, including to acquire or invest in complementary businesses, technologies or other assets.

2021 Outlook

Pending the completion of the acquisition of Decipher Biosciences, which is assumed to occur by April 1, 2021, Veracyte expects total combined revenue in 2021 to be approximately $190 million to $200 million, representing growth of approximately 65% over 2020 at the midpoint of the range.

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/p7geixt9. 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 can be accessed as follows:

U.S./Canada participant dial-in number (toll-free):

(855) 541-0980

International participant dial-in number:

(970) 315-0440

Conference I.D.:

7487201

About Veracyte

Veracyte (Nasdaq: VCYT) is a global genomic diagnostics company that improves patient care by providing answers to clinical questions, informing diagnosis and treatment decisions throughout the patient journey in cancer and other diseases. The company’s growing menu of genomic tests leverage advances in genomic science and technology, enabling patients to avoid risky, costly diagnostic procedures and quicken time to appropriate treatment. The company’s tests in thyroid cancer, lung cancer, breast cancer and idiopathic pulmonary fibrosis are available to patients and its lymphoma subtyping test is in development. With Veracyte’s exclusive global license to a best-in-class diagnostics instrument platform, the company is positioned to deliver its tests to patients worldwide. Veracyte is based in South San Francisco, California. For more information, please visit www.veracyte.com and follow the company on Twitter (@veracyte).

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, our statements related to our anticipated product launches for 2021; our financial and operating results for the year ending December 31, 2021; our plans, objectives, expectations (financial and otherwise) or intentions with respect to the anticipated acquisition of Decipher; the expected timing for completion of the transaction; and the expected benefits of the proposed transaction. Forward-looking statements can be identified by words such as: "appears," "anticipate," "intend," "plan," "expect," "believe," "should," "may," "will" 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: Veracyte’s ability to achieve and maintain Medicare coverage for its tests; the benefits of Veracyte’s tests, the applicability of clinical results to actual outcomes and the effects of the COVID-19 pandemic on Veracyte’s business and performance. Factors that may impact these forward-looking statements can be found in Veracyte’s filings with the Securities and Exchange Commission, including the risks set forth in its annual report on Form 10-K for the year ended December 31, 2020. A copy of these documents can be found at the Investors section of our website at www.veracyte.com. These forward-looking statements speak only as of the date hereof and Veracyte specifically disclaims 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, Afirma, Percepta, Envisia, Prosigna, "Know by Design" and the Veracyte, Afirma, Percepta, Envisia and Prosigna logos are registered trademarks in the U.S. and selected countries. We have common law rights and pending trademark applications for LymphMark and "More About You."

nCounter is the registered trademark of NanoString Technologies, Inc. in the United States and other countries and used by Veracyte under license.

VERACYTE, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

(In thousands of dollars, except share and per share amounts)

Three Months Ended December 31,

Twelve Months Ended December 31,

2020

2019

2020

2019

Revenue:

Testing revenue

$

31,497

$

28,557

$

101,970

$

107,355

Product revenue

2,696

923

9,845

923

Biopharmaceutical revenue

343

250

5,668

8,090

Collaboration revenue

4,000

Total Revenue

34,536

29,730

117,483

120,368

Operating expenses:

Cost of testing revenue

9,756

9,673

35,913

36,077

Cost of product revenue

1,382

446

4,921

446

Cost of biopharmaceutical revenue

49

621

Research and development

4,586

4,443

17,204

14,851

Selling and marketing

13,149

14,183

52,389

53,691

General and administrative

12,413

8,581

36,729

29,029

Intangible asset amortization

1,273

601

5,095

1,401

Total operating expenses

42,608

37,927

152,872

135,495

Loss from operations

(8,072

)

(8,197

)

(35,389

)

(15,127

)

Interest expense

(54

)

(81

)

(229

)

(677

)

Other income, net

82

820

709

3,205

Net loss and comprehensive loss

$

(8,044

)

$

(7,458

)

$

(34,909

)

$

(12,599

)

Net loss per common share, basic and diluted

$

(0.14

)

$

(0.15

)

$

(0.66

)

$

(0.27

)

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

58,023,753

49,095,703

53,239,231

46,138,177

VERACYTE, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

December 31,
2020

December 31,
2019

(Unaudited)

(See Note 1)

Assets

Current assets:

Cash and cash equivalents

$

349,364

$

159,317

Accounts receivable

18,461

19,329

Supplies

4,657

6,806

Prepaid expenses and other current assets

3,197

2,235

Total current assets

375,679

187,687

Property and equipment, net

8,990

8,933

Right-of-use assets - operating lease

7,843

8,808

Finite-lived intangible assets, net

59,924

65,019

Goodwill

2,725

2,725

Restricted cash

603

603

Other assets

1,399

1,437

Total assets

$

457,163

$

275,212

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable

$

3,116

$

2,328

Accrued liabilities

11,705

13,734

Current portion of deferred revenue

371

Current portion of operating lease liability

1,589

1,407

Total current liabilities

16,781

17,469

Long-term debt

810

694

Deferred revenue, net of current portion

829

Acquisition-related contingent consideration

7,594

6,088

Operating lease liability, net of current portion

9,917

11,506

Total liabilities

35,931

35,757

Total stockholders’ equity

421,232

239,455

Total liabilities and stockholders’ equity

$

457,163

$

275,212

(1) The condensed balance sheet at December 31, 2019 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 February 25, 2020.

VERACYTE, INC.

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS

(Unaudited)

(in thousands of dollars)

Twelve Months Ended December 31,

2020

2019

Operating activities

Net loss

$

(34,909

)

$

(12,599

)

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

Depreciation and amortization

7,944

4,117

Gain on disposal of property and equipment

(23

)

Stock-based compensation

12,995

9,807

Amortization of debt issuance costs

83

Interest on end-of-term debt obligation

216

229

Write-down of excess supplies

1,088

Noncash lease expense

964

1,034

Revaluation of acquisition-related contingent consideration

1,506

Impairment loss

1,000

Effect of foreign currency on operations

(34

)

Changes in operating assets and liabilities:

Accounts receivable

955

(6,161

)

Supplies

1,061

(3,404

)

Prepaid expenses and other current assets

(970

)

154

Other assets

37

(351

)

Operating lease liability

(1,407

)

(1,205

)

Accounts payable

711

(141

)

Accrued liabilities and deferred revenue

(868

)

5,228

Net cash used in operating activities

(9,711

)

(3,232

)

Investing activities

Purchases of property and equipment

(2,837

)

(2,756

)

Purchase of equity securities

(1,000

)

Cash paid for acquisition

(40,000

)

Proceeds from disposal of property and equipment

23

Net cash used in investing activities

(3,837

)

(42,733

)

Financing activities

Proceeds from the issuance of common stock in a public offering, net

193,831

137,848

Payment of long-term debt

(100

)

(24,900

)

Payment of finance lease liability

(308

)

Payment of taxes on vested restricted stock units

(3,845

)

(977

)

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

13,709

15,624

Net cash provided by financing activities

203,595

127,287

Net increase in cash, cash equivalents and restricted cash

190,047

81,322

Cash, cash equivalents and restricted cash at beginning of period

159,920

78,598

Cash, cash equivalents and restricted cash at end of period

$

349,967

$

159,920

Supplementary cash flow information of non-cash investing and financing activities:

Shares issued for purchase consideration for a business combination

$

$

10,000

Deferred purchase consideration for a business combination

$

$

6,088

Purchases of property and equipment included in accounts payable and accrued liabilities

$

294

$

226

Supplementary cash flow information:

Cash paid for interest on debt

$

13

$

332

Cash paid for tax

$

112

$

35

CASH, CASH EQUIVALENTS AND RESTRICTED CASH

(Unaudited)

(In thousands of dollars)

December 31, 2020

December 31, 2019

Cash and cash equivalents

$

349,364

$

159,317

Restricted cash

603

603

Total cash, cash equivalents and restricted cash

$

349,967

$

159,920

View source version on businesswire.com: https://www.businesswire.com/news/home/20210217005879/en/

Contacts

Investor and Media Contact:
Tracy Morris
Vice President of Corporate Communications
& Investor Relations
650-380-4413
tracy.morris@veracyte.com