VERACYTE INC
For the period ended Mar 31, 2025. Filed May 8, 2025.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 8, 2025
VCYT$24.16+0.7%Stored close · as of Nov 6, 2026
What changed in Risk Factors?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-07.
0001384101-24-000162
Item 1A. Risk FactorsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-08.
0001384101-25-000060
Item 1A. Risk FactorsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 397 previous paragraphs and 3 current paragraphs.
2 unchanged; 0 reworded; 1 added; 395 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
The current filing states there were no material changes to risk factors.
This is the filer’s own statement, not a conclusion from the comparison. Read its qualifications and the report it references.
Current filing’s statement
In addition to the information set forth in this report, you should consider carefully the factors and other cautionary statements discussed in the section titled “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K. There have been no material changes in our risk factors from those described in our Annual Report.
Added paragraphs (1)
Current report
In addition to the information set forth in this report, you should consider carefully the factors and other cautionary statements discussed in the section titled “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K. There have been no material changes in our risk factors from those described in our Annual Report.
Removed paragraphs (395)
Previous report
Investing in our common stock involves a high degree of risk. You should carefully review the “Risk Factors” section before you invest in shares of our common stock. Listed below are some of the more significant risks relating to an investment in our common stock.
Previous report
•We have a history of losses, we could incur net losses in the future, and we may not sustain our level of profitability in the future.
Previous report
•Our financial results currently depend mainly on sales of our Decipher Prostate and Afirma tests, and we will need to generate sufficient revenue from these and our other diagnostic tests to grow our business.
Previous report
•If we are unable to grow sales of our portfolio of tests or products, or we are unable to launch or commercialize our new tests or products, our business may suffer.
Previous report
•We depend on a few payers for a significant portion of our revenue; if one or more significant payers stops providing reimbursement or decreases the amount of reimbursement for our tests our revenue could decline.
Previous report
•If payers do not provide reimbursement, rescind or modify their reimbursement policies, delay payments for our tests, recoup past payments, or if we are unable to successfully negotiate additional reimbursement contracts, our commercial success could be compromised.
Previous report
•We may experience limits on our revenue if physicians decide not to order our tests or if patients decide not to use our tests as a result of increased costs, fees or changing insurer policies.
Previous report
•If we fail to comply with federal, state and foreign licensing requirements, we could lose the ability to perform our tests or experience disruptions to our business.
Previous report
•Our quarterly operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts for various reasons, including in response to the way we recognize revenue, our level of profitability and/or the amount of cash we generate, which may cause our stock price to fluctuate or decline.
Previous report
•If our general strategy of seeking growth through acquisitions and collaborations is not successful, or if we do not successfully integrate companies or assets that we acquire into our business, our prospects and financial condition will suffer.
Previous report
•Our future success and international growth depend, in part, on our ability to adapt, manufacture and distribute our tests as IVD tests.
Previous report
•We rely on sole suppliers for some of the reagents, equipment, and other materials used to perform or develop our tests, as well as certain sole source providers for kit components, instruments and associated services. We may not be able to find replacements or transition to alternative suppliers or service providers, which may materially impact our ability to generate revenue.
Previous report
•We may be unable to manage our future growth effectively, which could make it difficult to execute our business strategy.
Previous report
•If we are unable to support demand for our tests, products or services, our business could suffer.
Previous report
•Changes in healthcare policy, including legislation reforming the U.S. healthcare system, recent U.S. Supreme Court judicial decisions and potential changes in the regulatory environment, may have a material adverse effect on our financial condition and operations.
Previous report
•Because of Medicare billing rules, we may not receive reimbursement for all tests provided to Medicare patients.
Previous report
•FDA or foreign authorities regulation of those of our tests that they do not currently regulate could result in Veracyte incurring substantial costs and delays associated with trying to obtain premarket clearance, approval or certification.
Previous report
•Obtaining marketing authorization or certification by the FDA and foreign regulatory authorities or notified regulatory bodies for our diagnostic tests will take significant time and require significant research, development and clinical study expenditures and ultimately may not succeed.
Previous report
•If we are unable to compete successfully, we may be unable to increase or sustain our revenue and profitability.
Previous report
•We depend on our senior management team, and the loss of one or more of our executive officers, or the inability to attract and retain highly-skilled employees or other key personnel, could adversely affect our business.
Previous report
•Billing for our diagnostic tests is complex, and we must dedicate substantial time and resources to the billing process in order to collect cash and be paid.
Previous report
•If our internal sales force is less successful than anticipated, our business expansion plans could suffer and our ability to generate revenue could be diminished.
Previous report
•Developing new products involves a lengthy and complex process, and if we do not achieve our projected development and commercialization goals in the timeframes we announce and expect, our business will suffer and our stock price may decline.
Previous report
•We must successfully integrate acquired businesses to realize the financial goals that we currently anticipate.
Previous report
•Aspects of our international business expose us to business, personnel, regulatory, political, operational, financial, and economic risks associated with doing business outside of the United States.
Previous report
•Our operating results may be adversely affected by unfavorable macroeconomic and market conditions.
Previous report
•Security breaches, loss of data and other disruptions to our or our third-party service providers' data systems could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.
Previous report
•If we are unable to protect or successfully defend our intellectual property effectively, our business may be harmed.
Previous report
•We may be involved in litigation related to intellectual property, which may be time-intensive and costly and may adversely affect our business, operating results or financial condition.
Previous report
•If we are unable to implement and maintain effective internal control over financial reporting, investors may lose confidence in the accuracy and completeness of our reported financial information and the market price of our common stock may be negatively affected.
Previous report
•Our stock price may be volatile, and you may not be able to sell shares of our common stock at or above the price you paid.
Previous report
We have a history of losses, we could incur net losses in the future and we may not sustain our level of profitability in the future.
Previous report
For the nine months ended September 30, 2024 and 2023, we had net income of $19 million and net loss of $46 million, respectively. As of September 30, 2024, we had an accumulated deficit of $449 million. Although we recorded net income in the nine months ended September 30, 2024, we could incur losses in the future. Ongoing widespread inflationary pressures in the United States and across global economies have resulted in higher costs for our raw materials, non-material costs, labor and other business costs, and significant increases in the future could adversely affect our results of operations. We may not achieve profitability in a reporting period or, if we do so, we may not sustain such levels of profitability, and our failure to do so in the future could cause the market price of our common stock to decline.
Previous report
In addition, our ability to sustain profitability depends on a number of factors, including but not limited to:
Previous report
•Generating sufficient revenue from our existing diagnostic tests;
Previous report
•Developing and publishing evidence that our tests are informing clinical decisions and receiving positive coverage decisions by payers;
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