VERACYTE INC
For the period ended Jun 30, 2024. Filed Aug 7, 2024.
View on SEC.govAbout this filing
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.
Jun 30, 2024 · Filed Aug 7, 2024
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
Table of Contents
INDEX
| PageNo. | |
|---|---|
| PART I. — FINANCIAL INFORMATION | |
| Item 1. Condensed Consolidated Financial Statements (Unaudited) | 1 |
| Condensed Consolidated Balance Sheets as of June 30, 2024 and December 31, 2023 | 1 |
| Condensed Consolidated Statements of Operations for the Three and Six Month Periods Ended June 30, 2024 and 2023 | 2 |
| Condensed Consolidated Statements of Comprehensive Income (Loss) for the Three and Six Month Periods Ended June 30, 2024 and 2023 | 3 |
| Condensed Consolidated Statements of Stockholders' Equity for the Three and Six Month Periods Ended June 30, 2024 and 2023 | 4 |
| Condensed Consolidated Statements of Cash Flows for the Six Month Periods Ended June 30, 2023 and 2023 | 6 |
| Notes to Condensed Consolidated Financial Statements | 7 |
| Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations | 20 |
| Item 3. Quantitative and Qualitative Disclosures About Market Risk | 32 |
| Item 4. Controls and Procedures | 33 |
| PART II. — OTHER INFORMATION | |
| Item 1A. Risk Factors | 34 |
| Item 2. Unregistered Sales of Equity Securities and Use of Proceeds | 71 |
| Item 3. Defaults Upon Senior Securities | 71 |
| Item 4. Mine Safety Disclosures | 71 |
| Item 5. Other Information | 71 |
| Item 6. Exhibits | 71 |
| SIGNATURES | 73 |
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this Quarterly Report on Form 10-Q other than statements of historical fact, including statements concerning our business strategy and plans, future operating results and financial position, as well as our objectives and expectations for our future operations, are forward-looking statements.
In some cases, you can identify forward-looking statements by such terminology as “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect” and similar expressions that convey uncertainty of future events or outcomes, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements about:
the factors that may impact our financial results;
our expectations regarding total revenue and total test volume;
our expectations with respect to our future research and development, general and administrative and selling and marketing expenses and our anticipated uses of our funds;
our expectations with respect to the impact of inflation, volatile interest rates and foreign exchange fluctuations, the war in Ukraine and the ongoing conflict in the Middle East, any impacts of the upcoming U.S. election, energy and supply chain disruptions, and the resulting market volatility on our business;
our beliefs with respect to importance of maintaining libraries of clinical evidence;
our expectations regarding the Percepta Nasal Swab classifier for early lung cancer classification;
our expectations regarding the addition of minimal residual detection capabilities to our diagnostic platform;
our expectations regarding the timing and success of our transition to offering more of our tests as in vitro diagnostic tests on multiple platforms worldwide;
our ability to continue to receive quality reagents and other raw materials from certain single source suppliers, and to manufacture our in vitro diagnostics, or IVD, products;
our ability to successfully integrate C2i Genomics, Inc., or C2i, HalioDx and Decipher Biosciences into our business and our ability to run our tests on the nCounter Analysis System, as well as other platforms worldwide;
our expectations regarding our partnerships and agreements;
our expectations regarding capital expenditures, our anticipated cash needs and our estimates regarding our capital requirements and profitability;
our business strategy and our ability to execute on our strategy;
our ability to obtain and maintain Medicare, other government payer, and other commercial third party payer reimbursement at acceptable levels and our expectations regarding the timing of reimbursement;
our expectations with regard to the estimated number of patients eligible for our tests and the attributes and potential benefits of our tests and any future tests we may develop to patients, physicians, and payers;
our expectations on our ability to drive demand for and reimbursement of our tests; our sales, marketing and distribution capabilities and strategy;
our intellectual property position;
the impact of government laws and regulations, policies, guidance agency interpretations and judicial decisions; and
our beliefs in our competitive position.
We caution you that the foregoing list does not contain all of the forward-looking statements made in this report. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our business, financial condition, results of operations, prospects, and financial needs. These forward-looking statements speak only as of the date of this Quarterly Report on Form 10-Q and are subject to a number of risks, uncertainties and assumptions described in the section titled “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified, you should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. We disclaim any intention or obligation to publicly update or revise any forward-looking statements for any reason or to conform such statements to actual results or revised expectations, except as required by law.
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