Company: VCYT
Filing Date: 2025-02-28
Form Type: 10-K
Source: 0001384101-25-000014
Chunk: 111

Company: VERACYTE, INC.
Filing Date: 2025-02-28
Form: 10-K
Item: Item 1A
Chunk 111
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 amount of cash we generate, which may cause our stock price to fluctuate or decline.

Our quarterly financial and operating results depend on sales of our products in the markets we operate and are sensitive to a number of factors, including reimbursement, patient and clinician demand, market conditions in the United States and globally, and the prevalence of the indications we seek to address. In addition, we cannot be sure that we will be able to successfully complete development of or commercialize any of our planned future products, or that they will prove to be capable of reliably being used. Before we can successfully develop and commercialize any of our currently planned or other new diagnostic solutions, we will need to:

•conduct substantial research and development;

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•obtain the necessary testing samples and related data;

•conduct analytical and clinical validation studies, as well as clinical utility studies;

•expend significant funds;

•expand and scale-up our laboratory processes;

•expand and train our sales force;

•gain acceptance from a large number of ordering clinicians;

•gain acceptance from ordering laboratories; and

•seek and obtain regulatory clearances, approvals or certifications of our new solutions, as required by applicable regulatory bodies.

This process involves a high degree of risk and may take up to several years or more. Our test development and commercialization efforts may be delayed or fail for many reasons, including:

•failure of the test at the research or development stage;

•difficulty in accessing suitable testing samples, especially testing samples with known clinical results;

•lack of analytical and clinical validation data to support the effectiveness of the test, or lack of clinical utility data to support the value of the test;

•delays resulting from the failure of third-party suppliers or contractors to meet their obligations in a timely and cost-effective manner;

•failure to obtain or maintain necessary clearances, approvals or certifications to market the test;

•manufacturing constraints due to limited energy supply in Europe or other supply constraints; or

•lack of commercial acceptance by patients, clinicians or third-party payers.

Few research and development projects result in commercial products, and success in early clinical studies often is not replicated in later studies. At any point, we may abandon development of new diagnostic tests, or we may be required to expend considerable resources repeating clinical studies, which would adversely impact the timing for generating potential revenue from those new diagnostic tests. In addition, as we develop tests, we will have to make additional investments in our laboratory operations as well as sales and marketing operations, which may be prematurely or unnecessarily incurred if the