false 0001384101 0001384101 2020-11-02 2020-11-02

Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 2, 2020
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation)
Commission File Number
(IRS Employer Identification No.)
6000 Shoreline Court, Suite 300, South San Francisco, California
(Address of principal executive offices)
(Zip Code)
Registrant’s telephone number, including area code: (650) 243-6300
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Securities registered pursuant to Section 12(b) of the Act:
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Common Stock, par value, $0.001 per share
The Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
Emerging growth company
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Item 2.02 Results of Operations and Financial Condition.
On November 2, 2020, Veracyte, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2020. The full text of the press release is furnished as Exhibit 99.1 to this report.
The information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”), or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
d) Exhibits
Exhibit No.
Cover Page Interactive Data File (embedded within the Inline XBRL document).

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
November 2, 2020
/s/ Keith Kennedy
Keith Kennedy
Chief Operating Officer and Chief Financial Officer
(Principal Financial Officer)

Exhibit 99.1

For Immediate Release


Veracyte Announces Third Quarter 2020 Financial Results


Revenue of $31.1 Million; Product and Testing Revenue Increased 79% Over Second Quarter of 2020


Achieved Key Reimbursement Milestones


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



SOUTH SAN FRANCISCO, Calif., November 2, 2020-- Veracyte, Inc. (Nasdaq: VCYT) today announced financial results for the third quarter ended September 30, 2020 and provided an update on recent business progress. For the third quarter of 2020, revenue was $31.1 million, compared to $20.7 million in the second quarter of 2020 and $31.0 million in the third quarter of 2019. Product and testing revenue was $30.3 million, an increase of 79% over the second quarter of 2020 and 13% over the third quarter of 2019.



“We are pleased with the strong rebound in our business during the third quarter, with revenue returning to pre-pandemic levels, led by our Afirma franchise,” said Bonnie Anderson, Veracyte’s chairman and chief executive officer. “We also achieved important reimbursement and clinical-evidence milestones for our tests, which we believe will help further drive adoption and revenue growth. We also remain on track to launch four new clinical products in 2021. Moreover, we believe we are well-positioned in the near- and long-term with our tests that help patients avoid unnecessary invasive diagnostic procedures and accelerate access to appropriate treatment.”


Third Quarter 2020 Financial Results


For the third quarter of 2020:



Total Revenue was $31.1 million, comprising $30.3 million in testing and product revenue and $0.8 million in biopharmaceutical partnership revenue;  

Gross Margin was 67%;


Operating Expenses, Excluding Cost of Revenue, were $24.8 million;


Net Loss and Comprehensive Loss was $4.1 million;


Basic and Diluted Net Loss Per Common Share was $0.08;


Net Cash Used in Operating Activities was $1.8 million; and


Cash and Cash Equivalents were $345.1 million at September 30, 2020.





For the nine-month period ended September 30, 2020:



Total Revenue was $82.9 million, comprising $77.6 million in testing and product revenue and $5.3 million in biopharmaceutical partnership revenue;

Gross Margin was 64%;


Operating Expenses, Excluding Cost of Revenue, were $80.0 million;


Net Loss and Comprehensive Loss was $26.9 million;


Basic and Diluted Net Loss Per Common Share was $0.52; and


Net Cash Used in Operating Activities was $12.0 million.



Third Quarter 2020 and Recent Business Highlights


Commercial Growth and Reimbursement Expansion:



Grew reported genomic testing volume (Afirma, Percepta and Envisia) to 10,242, an increase of 90% over the second quarter of 2020 and 3% over the third quarter of 2019. 

Generated $7.0 million in year-to-date 2020 revenue from our Prosigna breast cancer test, achieving our pre-pandemic, full-year 2020 revenue goal. 

Received Advanced Diagnostic Laboratory Test (ADLT) status and new Medicare pricing for the Envisia classifier, beginning October 1, 2020, positioning the test for expanded revenue growth.  

Received new CPT codes and preliminary national Medicare pricing for the Afirma Medullary Thyroid Carcinoma (MTC) classifier and the Xpression Atlas, providing a pathway for increased reimbursement. 
  Obtained coverage for the Prosigna breast cancer test from the Federal Joint Committee (G-BA) in Germany, our third largest European market. 


Evidence Development:






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



Data from the TransATAC study were published in the Journal of Clinical Oncology elucidating the foundational molecular biology on which the Prosigna test is based and its higher likelihood of predicting long-term risk of recurrence among certain groups of women with early-stage breast cancer, compared to other breast cancer genomic tests.  





An independent study published in Cytopathology by UCLA researchers showed that use of the Afirma GSC further reduced unnecessary surgeries in thyroid cancer diagnosis compared to the original Afirma test. 





Presented three e-Posters at the American Thoracic Society 2020 Virtual Meeting featuring real-world data that reinforce previous findings suggesting that the Percepta and Envisia classifiers improve the diagnosis of lung cancer and interstitial lung diseases (ILDs).



Published data in the journal CHEST suggesting that the Percepta classifier reduces unnecessary invasive procedures following inconclusive bronchoscopy results for patients with lung nodules and that these results are durable for over one year of follow-up. 



Presented an oral and e-Poster presentation at CHEST Annual Meeting 2020 supporting advancement of our lung cancer nasal swab classifier, along with the potential to integrate radiologic data to further augment genomics in the diagnosis of ILDs, including idiopathic pulmonary fibrosis.  





Issued and sold 6,900,000 shares of common stock in August 2020 in a registered public offering, including the underwriters’ exercise in full of their option to purchase an additional 900,000 shares, at a price to the public of $30.00 per share. Net proceeds from the offering were approximately $194 million.


2020 Financial Guidance

While Veracyte experienced improved business trends in the third quarter, due to the continued uncertainties with respect to the COVID-19 pandemic, the company will not be providing guidance at this time.


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: 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




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.:



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 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 plans, objectives, expectations (financial and otherwise) or intentions with respect to our Prosigna, Afirma, Percepta, Envisia, and nasal swab tests and products for use in diagnosing and treating diseases. 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 Item 1A – “Risk Factors” in our Annual Report on Form 10-K filed with the SEC on February 25, 2020 and in our Quarterly Report on Form 10-Q to be filed with the SEC on November 2, 2020. A copy of these documents can be found at the Investors section of our website at 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.”







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



Three Months Ended September 30,


Nine Months Ended September 30,












Testing revenue

  $ 28,270     $ 26,723     $ 70,473     $ 78,798  

Product revenue

    2,027             7,149        

Biopharmaceutical revenue

    824       2,250       5,325       7,840  
Collaboration revenue           2,000             4,000  

Total Revenue

    31,121       30,973       82,947       90,638  

Operating expenses:


Cost of testing revenue

    9,118       9,114       26,157       26,404  

Cost of product revenue

    1,048             3,539        

Cost of biopharmaceutical revenue

    204             572        

Research and development

    4,042       3,643       12,618       10,408  

Selling and marketing

    10,955       13,088       39,240       39,508  

General and administrative

    8,546       6,624       24,316       20,448  

Intangible asset amortization

    1,274       267       3,822       800  

Total operating expenses

    35,187       32,736       110,264       97,568  

Loss from operations

    (4,066 )     (1,763 )     (27,317 )     (6,930 )

Interest expense

    (55 )     (58 )     (175 )     (596 )

Other income (loss), net

    (3 )     1,091       627       2,385  

Net loss and comprehensive loss

  $ (4,124 )   $ (730 )   $ (26,865 )   $ (5,141 )

Net loss per common share, basic and diluted

  $ (0.08 )   $ (0.02 )   $ (0.52 )   $ (0.11 )

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

    54,858,052       48,588,296       51,632,750       45,141,502  






(In thousands)



September 30, 2020


December 31, 2019

    (Unaudited)     (See Note 1)  



Current assets:


Cash and cash equivalents

  $ 345,080     $ 159,317  

Accounts receivable

    17,629       19,329  


    4,456       6,806  

Prepaid expenses and other current assets

    3,150       2,235  

Total current assets

    370,315       187,687  

Property and equipment, net

    8,914       8,933  

Right-of-use assets - operating lease

    8,094       8,808  

Finite-lived intangible assets, net

    61,197       65,019  


    2,725       2,725  

Restricted cash

    603       603  

Other assets

    2,303       1,437  

Total assets

  $ 454,151     $ 275,212  

Liabilities and Stockholders’ Equity


Current liabilities:


Accounts payable

  $ 1,932     $ 2,328  

Accrued liabilities

    10,445       13,734  

Current portion of operating lease liability

    1,542       1,407  

Total current liabilities

    13,919       17,469  

Long-term debt

    756       694  

Acquisition-related contingent consideration

    6,420       6,088  

Operating lease liability, net of current portion

    10,331       11,506  

Total liabilities

    31,426       35,757  

Total stockholders’ equity

    422,725       239,455  

Total liabilities and stockholders’ equity

  $ 454,151     $ 275,212  



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.







(in thousands of dollars)



Nine Months Ended September 30,






Operating activities


Net loss

  $ (26,865 )   $ (5,141 )
Adjustments to reconcile net loss to net cash used in operating activities:                

Depreciation and amortization

    5,919       2,836  

Gain on disposal of property and equipment

          (23 )

Stock-based compensation

    9,354       6,965  

Amortization of debt issuance costs


Interest on end-of-term debt obligation

    162       174  

Write-down of excess supplies


Noncash lease expense

    714       810  

Revaluation of acquisition-related contingent consideration

Effect of foreign currency on operations     (17 )      
Changes in operating assets and liabilities:                

Accounts receivable

    1,742       (10,445 )


    1,262       (3,206 )

Prepaid expenses and other current assets

    (923 )     185  

Other assets

    134       (142 )

Operating lease liability

    (1,040 )     (881 )

Accounts payable

    (534 )     2,505  

Accrued liabilities

    (3,300 )     1,258  

Net cash used in operating activities

    (11,972 )     (5,022 )

Investing activities


Purchases of property and equipment

    (1,949 )     (1,656 )
Purchase of equity securities     (1,000 )      

Proceeds from disposal of property and equipment


Net cash used in investing activities

    (2,949 )     (1,633 )

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

          (229 )

Payment of taxes on vested restricted stock units

    (3,161 )     (810 )

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

    10,114       12,413  

Net cash provided by financing activities

    200,684       124,322  

Net increase in cash, cash equivalents and restricted cash

    185,763       117,667  

Cash, cash equivalents and restricted cash at beginning of period

    159,920       78,598  

Cash, cash equivalents and restricted cash at end of period

  $ 345,683     $ 196,265  

Supplementary cash flow information:


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

  $ 355     $ 821  

Interest paid on debt

  $ 3     $ 330  






(In thousands of dollars)



September 30, 2020


December 31, 2019


Cash and cash equivalents

  $ 345,080     $ 159,317  

Restricted cash

    603       603  

Total cash, cash equivalents and restricted cash

  $ 345,683     $ 159,920  




Investor and Media Contact:


Tracy Morris

Vice President of Corporate Communications

 & Investor Relations