UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 8, 2014
VERACYTE, INC.
(Exact name of registrant as specified in its charter)
Delaware |
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001-36156 |
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20-5455398 |
(State or other jurisdiction |
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(Commission |
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(IRS Employer |
of incorporation) |
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File Number) |
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Identification No.) |
7000 Shoreline Court, Suite 250, South San Francisco, California |
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94080 |
(Address of principal executive offices) |
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(Zip Code) |
Registrants telephone number, including area code: (650) 243-6300
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:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02 Results of Operations and Financial Condition.
On May 8, 2014, Veracyte, Inc. issued a press release announcing its financial results for the fiscal quarter ended March 31, 2014. 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. |
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Description |
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99.1 |
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Press Release issued by Veracyte, Inc. dated May 8, 2014. |
SIGNATURES
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.
Dated: May 8, 2014 |
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Veracyte, Inc. | |
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By |
/s/ Shelly D. Guyer |
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Name: |
Shelly D. Guyer |
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Title: |
Chief Financial Officer |
Exhibit 99.1
FOR IMMEDIATE RELEASE
Veracyte, Inc. Announces First Quarter 2014 Financial Results
1Q Revenue Increased 71%, Compared to Prior Year
First Blue Cross Plan Issues Coverage for Afirma® Gene Expression Classifier (GEC);
Total Covered Lives Exceeds 125 Million
Conference Call and Webcast Today at 5 p.m. ET
South San Francisco, Calif. May 8, 2014 Veracyte, Inc. (Nasdaq: VCYT) today reported financial results for the first quarter ended March 31, 2014, and provided an update on recent business progress. For the first quarter of 2014, revenue was $7.5 million, an increase of 71%, compared to $4.4 million for the first quarter of 2013.
We continued to accelerate our business in the first quarter of 2014, said Bonnie H. Anderson, Veracytes president and chief executive officer. This included strong payer progress, notably the first positive coverage policy for Afirma from a Blue Cross plan. We believe our growing success with payers and increasing adoption by physicians reflect Afirmas compelling value proposition in thyroid cancer diagnosis by reducing unnecessary thyroid surgeries and corresponding medical system costs. We look forward to continuing to build upon our strong commercial momentum for Afirma and remain on track with development of our next product, which will target interstitial lung diseases.
First Quarter 2014 Financial Results
· The company received 14,373 FNA samples during the first quarter of 2014, compared to 10,757 FNA samples during the same period in 2013, an increase of 34%.
· Afirma GEC tests have increased to 22% of FNA samples received, reflecting our success in penetrating institutional clients with an Afirma enabled business model, through which we receive FNA samples for GEC testing only.
· Operating expenses for the first quarter of 2014 were $14.1 million, compared with operating expenses of $10.3 million for the comparable period in 2013, with the increase due primarily to the costs of being a public company. These operating expenses also included cost of revenue of $3.6 million for the first quarter of 2014 versus $2.8 million for the comparable period in 2013.
· Net loss for the first quarter of 2014 was $6.7 million, or $0.32 per common share, compared with a net loss of $6.9 million, or $9.04 per common share, for the same period in 2013.
· Cash and cash equivalents as of March 31, 2014, totaled $64.2 million.
Recent Business Highlights
· Exceeded 125 million covered lives for the Afirma GEC, including a positive coverage policy from Premera Blue Cross, the first Blue Cross payer to cover the genomic test.
· Entered first international market through a partnership with Fleury Health and Medicine in Brazil.
· Invited to present four studies at the AACE conference in May, highlighting data that support the launch of our Afirma Malignancy Classifiers and enhance our overall Afirma solution.
· Accepted for an oral presentation at the American Thoracic Society meeting in May to present proof-of-concept data for the development of a diagnostic test in our next targeted clinical indication pulmonology.
Conference Call/Webcast Details
Veracyte will host a conference call and webcast today at 5 p.m. Eastern Time to discuss the companys financial results and provide a general business update. The webcast and subsequent replay may be accessed by visiting Veracytes website at http://investor.veracyte.com. Please connect to the companys website at least 15 minutes prior to the webcast to ensure adequate time for any necessary software download. Alternatively, please call (855) 541-0980 (U.S.) or (970) 315-0440 (international) to listen to the conference call. The conference ID number for the call is 33493732. Please dial in approximately 10 minutes prior to the call. The webcast will be available on the companys website approximately two hours following completion of the call for 14 days.
About Veracyte, Inc.
Veracyte (Nasdaq: VCYT) is pioneering the field of molecular cytology, focusing on genomic solutions that resolve diagnostic ambiguity and enable physicians to make more informed treatment decisions at an early stage in patient care. By improving preoperative diagnostic accuracy, the company aims to help patients avoid unnecessary invasive procedures while reducing healthcare costs. Veracytes first commercial solution, the Afirma® Thyroid FNA Analysis, utilizes the proprietary Gene Expression Classifier (GEC) to resolve ambiguity in thyroid nodule diagnosis. Each year, of the more than 525,000 thyroid nodule FNAs performed in the U.S., approximately 115,000 patients undergo diagnostic thyroid surgery, with 70% to 80% of nodules proving benign and thus the surgery unnecessary. Since the commercial launch of Afirma in January 2011, Veracyte has received nearly 100,000 FNA samples for evaluation using Afirma and has performed nearly 20,000 GECs to resolve indeterminate cytopathology results, as of March 31, 2014. Backed by multiple, peer-reviewed, published studies and included in leading medical guidelines, Afirma is covered by Medicare and major commercial payers, which collectively represent more than 125 million covered lives. Afirma is marketed and sold through a global co-promotion agreement with Genzyme Corporation, a subsidiary of Sanofi. Veracyte intends to expand its molecular cytology franchise to other clinical areas and is in late biomarker discovery for its first product in pulmonology. For more information, please visit www.veracyte.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to future revenue levels and FNA volumes, the companys expectations regarding its continuing growth and the drivers of growth, the companys beliefs regarding the benefits of its tests to physicians, patients and payers, the companys belief that it is on track with development of a product for interstitial lung diseases, and the companys intent to expand its molecular cytology business into other clinical areas. Forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: our limited operating history and history of losses; our ability to increase usage of and reimbursement for Afirma and any future products we may develop; our dependence on a few payers for a significant portion of our revenue; the complexity, time and expense associated with billing and collecting from payers for our test; laws and regulations applicable to our business, including potential regulation by the Food and Drug Administration or other regulatory bodies; our dependence on strategic relationships; our ability to develop and commercialize new products and the timing of commercialization; the occurrence and outcome of clinical studies; the timing and publication of study results; the applicability of clinical results to actual outcomes; our inclusion in clinical practice guidelines; our ability to compete; our ability to expand into international markets; our ability to obtain capital when needed; and other risks set forth in the companys filings with the Securities and Exchange Commission, including the risks set forth in the companys Annual Report on Form 10-K for the year ended December 31, 2013. These forward-looking statements speak only as of the date hereof and Veracyte specifically disclaims any obligation to update these forward-looking statements.
Veracyte, Afirma, the Veracyte logo, and the Afirma logo are trademarks of Veracyte, Inc. This press release also contains trademarks and trade names that are the property of their respective owners.
VERACYTE, INC.
Condensed Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except share and per share amounts)
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Three Months Ended |
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2014 |
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2013 |
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Revenue |
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$ |
7,476 |
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$ |
4,384 |
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Operating expenses: |
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Cost of revenue |
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3,607 |
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2,773 |
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Research and development |
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2,126 |
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2,010 |
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Selling and marketing |
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4,336 |
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2,703 |
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General and administrative |
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3,982 |
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2,791 |
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Total operating expenses |
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14,051 |
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10,277 |
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Loss from operations |
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(6,575 |
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(5,893 |
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Interest expense |
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(111 |
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Other income (expense), net |
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12 |
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(1,002 |
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Net loss and comprehensive loss |
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$ |
(6,674 |
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$ |
(6,895 |
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Net loss per common share, basic and diluted |
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$ |
(0.32 |
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$ |
(9.04 |
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Shares used to compute net loss per common share, basic and diluted |
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21,148,342 |
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763,021 |
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VERACYTE, INC.
CONDENSED BALANCE SHEETS
(In thousands, except share and per share amounts)
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March 31, |
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December 31, |
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(Unaudited) |
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(1) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
64,237 |
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$ |
71,220 |
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Accounts receivable |
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1,191 |
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1,143 |
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Supplies inventory |
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2,721 |
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2,567 |
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Prepaid expenses and other current assets |
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1,014 |
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1,477 |
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Total current assets |
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69,163 |
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76,407 |
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Property and equipment, net |
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3,028 |
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2,952 |
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Restricted cash |
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118 |
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118 |
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Other assets |
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145 |
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153 |
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Total assets |
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$ |
72,454 |
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$ |
79,630 |
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Liabilities and Stockholders Equity |
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Current liabilities: |
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Accounts payable |
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$ |
7,214 |
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$ |
5,294 |
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Accrued liabilities |
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5,267 |
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7,594 |
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Deferred Genzyme co-promotion fee |
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2,500 |
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2,500 |
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Current portion of long-term debt |
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467 |
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Total current liabilities |
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15,448 |
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15,388 |
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Long-term debt, net of current portion |
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4,467 |
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4,899 |
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Deferred rent, net of current portion |
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260 |
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286 |
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Deferred Genzyme co-promotion fee, net of current portion |
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1,989 |
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2,614 |
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Total liabilities |
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22,164 |
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23,187 |
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Total stockholders equity |
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50,290 |
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56,443 |
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Total liabilities and stockholders equity |
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$ |
72,454 |
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$ |
79,630 |
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(1) The condensed balance sheet at December 31, 2013 has been derived from the audited financial statements at that date included in the Companys Form 10-K filed with the Securities and Exchange Commission dated March 20, 2014.
Source: Veracyte
# # #
Media:
Tracy Morris
650-380-4413
Tracy.Morris@Veracyte.com
Investors:
Angeli Kolhatkar
Burns McClellan, Inc.
212-213-0006
akolhatkar@burnsmc.com