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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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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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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.
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Emerging growth company
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
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Exhibit No.
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Description
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99.1
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL document).
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Dated:
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July 30, 2020
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VERACYTE, INC.
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By:
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/s/ Keith Kennedy
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Name:
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Keith Kennedy
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Title:
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Chief Operating Officer and Chief Financial Officer
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(Principal Financial Officer)
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Exhibit 99.1
Veracyte Announces Second Quarter 2020 Financial Results
Revenue of $20.7 Million and Genomic Testing Volume of 5,379
Company Advances Pipeline and Global Expansion Strategy
Conference Call and Webcast Today at 4:30 p.m. ET
SOUTH SAN FRANCISCO, Calif., July 30, 2020-- Veracyte, Inc. (Nasdaq: VCYT) today announced financial results for the second quarter ended June 30, 2020 and provided an update on recent business progress.
“We delivered solid second quarter results in the face of headwinds from the COVID-19 pandemic,” said Bonnie Anderson, Veracyte’s chairman and chief executive officer. “Our genomic testing volume doubled between April and June as hospitals started performing more non-emergency procedures and physician practices began to open. We have begun leveraging opportunities for new virtual sales and marketing models to increase efficiency and drive growth. We also remain on track to bring four new tests to market in 2021, further accelerating our growth. Additionally, we continued to grow our biopharmaceutical and diagnostic partnerships to fuel our global expansion with a comprehensive test menu that extends our total addressable market beyond the $40 billion for our current and pipeline products.”
Second Quarter 2020 Financial Results
For the second quarter of 2020:
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Total revenue was $20.7 million, comprising $16.9 million in testing and product revenue and $3.8 million in biopharmaceutical partnership and collaboration revenue; |
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Gross Margin was 63%; |
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Operating Expenses, Excluding Cost of Revenue, were $24.1 million; |
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Net Loss and Comprehensive Loss was $11.0 million; |
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Basic and Diluted Net Loss Per Common Share was $0.22; |
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Net Cash Used in Operating Activities was $8.4 million; and |
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Cash and Cash Equivalents were $147.5 million at June 30, 2020. |
For the six-month period ended June 30, 2020:
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Total revenue was $51.8 million, comprising $47.3 million in testing and product revenue and $4.5 million in biopharmaceutical partnership and collaboration revenue; |
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Gross Margin was 62%; |
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Operating Expenses, Excluding Cost of Revenue, were $55.2 million; |
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Net Loss and Comprehensive Loss was $22.7 million; |
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Basic and Diluted Net Loss Per Common Share was $0.45; and |
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Net Cash Used in Operating Activities was $13.7 million. |
Second Quarter 2020 and Recent Business Highlights
Core Diagnostics Business:
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Increased our reported genomic testing volume (Afirma, Percepta and Envisia), with June total volume doubling that of April. |
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Expanded virtual customer engagement program, conducting more than two dozen virtual educational events, email campaigns and other digital outreach to clinicians. |
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Strengthened our library of published clinical evidence supporting use of the Afirma Xpression Atlas (Cancer Cytopathology) and the Envisia Genomic Classifier (CHEST and AJRCCM). The AJRCCM study further demonstrates the Envisia classifier’s ability to improve diagnosis of idiopathic pulmonary fibrosis without the need for surgery. |
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LymphMark – Submitted De Novo classification request to the FDA for the lymphoma subtyping test, which is designed to help inform diagnosis and better treatment decisions. | |
| • | On track to launch four new products in 2021: Nasal swab test for early lung cancer detection; Percepta Atlas to inform treatment decisions in lung cancer; Envisia international launch on the nCounter; and LymphMark, if the FDA grants our De Novo classification request. | |
| • | Signed distributor contracts that will make Veracyte’s advanced genomic testing on the nCounter system available to laboratories throughout the Asia Pacific region, as well as in Australia and New Zealand. |
Strategic Collaborations:
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CareDx – Formed strategic collaboration through which CareDx has the exclusive right to develop solid organ transplant rejection tests on the nCounter Analysis System, fueling our global menu expansion. |
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Generated revenue from four biopharmaceutical and diagnostics partners: Eli Lilly/Loxo Oncology, Johnson & Johnson Innovation, Acerta Pharma and CareDx. |
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MAVIDx – Signed strategic agreement, taking an equity stake in MAVIDx, for the new company to develop COVID-19 and other infectious disease tests for ultra-high throughput testing on the nCounter system. A Harvard University report estimates the market will require 20 million tests per day in the United States alone. |
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/xs86q7qz. 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.
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The conference call can be accessed as follows: |
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U.S./Canada participant dial-in number (toll-free): |
(855) 541-0980 |
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International participant dial-in number: |
(970) 315-0440 |
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Conference I.D.: |
2496566 | |
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" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "expect," "believe," "should," "may," "will" and similar references to future periods. Examples of forward-looking statements include, among others, statements regarding Veracyte’s financial and operational results for the second quarter ended June 30, 2020, anticipated timing of the launch of new products in 2021, availability of Veracyte’s testing internationally, Veracyte’s total addressable market, the current and future impacts of COVID-19 on Veracyte’s business, actions Veracyte has taken in response to COVID-19, and Veracyte’s long-term outlook. Forward-looking statements are neither historical facts nor assurances of future performance, but are based only on our current beliefs, expectations and assumptions. These statements involve risks and uncertainties, which could cause actual results to differ materially from our predictions, and include, but are not limited to: the impact of COVID-19 on Veracyte’s business and operating results, specifically, and the healthcare system and economy more generally, Veracyte’s ability to achieve and maintain Medicare coverage for its tests; the benefits of Veracyte’s tests and the applicability of clinical results to actual outcomes; the laws and regulations applicable to Veracyte’s business, including potential regulation by the Food and Drug Administration or other regulatory bodies; Veracyte’s ability to successfully achieve and maintain adoption of and reimbursement for its products; the amount by which use of Veracyte’s products are able to reduce invasive procedures and misdiagnosis, and reduce healthcare costs; the occurrence and outcomes of clinical studies; and other risks set forth in Veracyte’s filings with the Securities and Exchange Commission, including the risks set forth in its quarterly report on Form 10-Q for the quarter ended June 30, 2020. 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, LymphMark, and the Veracyte logo are trademarks of Veracyte, Inc.
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VERACYTE, INC. |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
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(Unaudited) |
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(In thousands of dollars, except share and per share amounts) |
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Three Months Ended June 30, |
Six Months Ended June 30, |
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2020 |
2019 |
2020 |
2019 |
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Revenues: |
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Testing revenue |
$ | 15,212 | $ | 26,686 | $ | 42,203 | $ | 52,075 | ||||||||
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Product revenue |
1,713 | — | 5,122 | — | ||||||||||||
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Biopharmaceutical revenue |
3,779 | 1,450 | 4,501 | 5,590 | ||||||||||||
| Collaboration revenue | — | 2,000 | — | 2,000 | ||||||||||||
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Total revenue |
20,704 | 30,136 | 51,826 | 59,665 | ||||||||||||
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Operating expenses: |
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Cost of testing revenue |
6,471 | 8,777 | 17,039 | 17,290 | ||||||||||||
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Cost of product revenue |
932 | — | 2,491 | — | ||||||||||||
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Cost of biopharmaceutical revenue |
252 | — | 368 | — | ||||||||||||
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Research and development |
4,169 | 3,330 | 8,576 | 6,765 | ||||||||||||
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Selling and marketing |
10,701 | 13,943 | 28,285 | 26,420 | ||||||||||||
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General and administrative |
7,957 | 6,920 | 15,770 | 13,824 | ||||||||||||
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Intangible asset amortization |
1,273 | 266 | 2,548 | 533 | ||||||||||||
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Total operating expenses |
31,755 | 33,236 | 75,077 | 64,832 | ||||||||||||
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Loss from operations |
(11,051 | ) | (3,100 | ) | (23,251 | ) | (5,167 | ) | ||||||||
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Interest expense |
(65 | ) | (235 | ) | (120 | ) | (538 | ) | ||||||||
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Other income, net |
91 | 841 | 630 | 1,294 | ||||||||||||
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Net loss and comprehensive loss |
$ | (11,025 | ) | $ | (2,494 | ) | $ | (22,741 | ) | $ | (4,411 | ) | ||||
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Net loss per common share, basic and diluted |
$ | (0.22 | ) | $ | (0.05 | ) | $ | (0.45 | ) | $ | (0.10 | ) | ||||
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Shares used to compute net loss per common share, basic and diluted |
50,212,123 | 45,586,081 | 50,002,377 | 43,389,540 | ||||||||||||
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VERACYTE, INC. |
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CONDENSED CONSOLIDATED BALANCE SHEETS |
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(In thousands) |
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June 30, 2020 |
December 31, 2019 |
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| (Unaudited) | (See Note 1) | |||||||
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Assets |
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Current assets: |
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Cash and cash equivalents |
$ | 147,450 | $ | 159,317 | ||||
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Accounts receivable |
15,306 | 19,329 | ||||||
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Supplies |
7,041 | 6,806 | ||||||
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Prepaid expenses and other current assets |
2,891 | 2,235 | ||||||
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Total current assets |
172,688 | 187,687 | ||||||
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Property and equipment, net |
8,640 | 8,933 | ||||||
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Right-of-use assets - operating lease |
8,339 | 8,808 | ||||||
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Finite-lived intangible assets, net |
62,471 | 65,019 | ||||||
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Goodwill |
2,725 | 2,725 | ||||||
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Restricted cash |
603 | 603 | ||||||
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Other assets |
1,271 | 1,437 | ||||||
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Total assets |
$ | 256,737 | $ | 275,212 | ||||
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
$ | 2,224 | $ | 2,328 | ||||
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Accrued liabilities |
9,386 | 13,734 | ||||||
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Current portion of operating lease liability |
1,495 | 1,407 | ||||||
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Total current liabilities |
13,105 | 17,469 | ||||||
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Long-term debt |
801 | 694 | ||||||
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Acquisition related contingent consideration |
5,948 | 6,088 | ||||||
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Operating lease liability, net of current portion |
10,736 | 11,506 | ||||||
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Total liabilities |
30,590 | 35,757 | ||||||
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Total stockholders’ equity |
226,147 | 239,455 | ||||||
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Total liabilities and stockholders’ equity |
$ | 256,737 | $ | 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. |
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VERACYTE, INC. |
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CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS |
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(Unaudited) |
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(in thousands of dollars) |
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Six Months Ended June 30, |
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2020 |
2019 |
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Operating activities |
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Net loss |
$ | (22,741 | ) | $ | (4,411 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
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Depreciation and amortization |
3,929 | 1,869 | ||||||
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Gain on disposal of property and equipment |
— | (17 | ) | |||||
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Stock-based compensation |
6,265 | 4,325 | ||||||
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Amortization of debt issuance costs |
— | 83 | ||||||
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Interest on end-of-term debt obligations |
107 | 120 | ||||||
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Write-down of excess supplies |
1,088 | — | ||||||
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Noncash lease expense |
469 | 431 | ||||||
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Revaluation of acquisition related contingent consideration |
(140 | ) | — | |||||
| Changes in operating assets and liabilities: | ||||||||
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Accounts receivable |
4,023 | (6,458 | ) | |||||
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Supplies |
(1,323 | ) | (1,702 | ) | ||||
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Prepaid expenses and other current assets |
(664 | ) | (192 | ) | ||||
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Operating lease liability |
(682 | ) | (604 | ) | ||||
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Other assets |
166 | 25 | ||||||
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Accounts payable |
122 | 1,746 | ||||||
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Accrued liabilities |
(4,343 | ) | 1,319 | |||||
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Net cash used in operating activities |
(13,724 | ) | (3,466 | ) | ||||
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Investing activities |
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Purchases of property and equipment |
(1,314 | ) | (1,424 | ) | ||||
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Proceeds from disposal of property and equipment |
— | 17 | ||||||
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Net cash used in investing activities |
(1,314 | ) | (1,407 | ) | ||||
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Financing activities |
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Proceeds from the issuance of common stock in a public offering, net of issuance costs |
— | 137,848 | ||||||
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Payment of long-term debt |
— | (24,900 | ) | |||||
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Payment of financial lease liability |
— | (152 | ) | |||||
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Payment of taxes on vested restricted stock units |
(2,678 | ) | (676 | ) | ||||
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Proceeds from the exercise of common stock options and employee stock purchases |
5,849 | 7,405 | ||||||
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Net cash provided by financing activities |
3,171 | 119,525 | ||||||
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Net (decrease) increase in cash, cash equivalents and restricted cash |
(11,867 | ) | 114,652 | |||||
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Cash, cash equivalents and restricted cash at beginning of period |
159,920 | 78,598 | ||||||
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Cash, cash equivalents and restricted cash at end of period |
$ | 148,053 | $ | 193,250 | ||||
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Supplementary cash flow information of non-cash investing and financing activities: |
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Purchases of property and equipment included in accounts payable and accrued liability |
$ | — | $ | 72 | ||||
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Interest paid on debt |
$ | 3 | $ | 319 | ||||
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CASH, CASH EQUIVALENTS AND RESTRICTED CASH |
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(Unaudited) |
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(In thousands of dollars) |
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June 30, 2020 |
December 31, 2019 |
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Cash and cash equivalents |
$ | 147,450 | $ | 159,317 | ||||
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Restricted cash |
603 | 603 | ||||||
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Total cash, cash equivalents and restricted cash |
$ | 148,053 | $ | 159,920 | ||||
#-#-#
Investor and Media Contact:
Tracy Morris
Vice President of Corporate Communications
& Investor Relations
650-380-4413
tracy.morris@veracyte.com