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Fulgent Genetics Inc

For the period ended Dec 31, 2023. Filed Feb 28, 2024.

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About this filing

A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.

FY2023 · Filed Feb 28, 2024

FLGT$23.74+27.2%Stored close · as of Nov 6, 2026
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Contents

Cautionary Note Regarding Forward-Looking Statements

This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Forward-looking statements are statements other than historical facts and relate to future events or circumstances or our future performance, and they are based on our current assumptions, expectations and beliefs concerning future developments and their potential effect on our business. The words “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect,” “possible,” “likely,” “probable,” and similar expressions that convey uncertainty of future events or outcomes identify forward-looking statements.

The forward-looking statements in this report include statements about, among other things:

developments, projections, and trends relating to us, our competitors, and our industry;

our plans for our business;

our ability to integrate any acquired businesses and technologies and to realize the value of any acquired entities, joint ventures, or investments;

our operating performance, including our ability to stabilize the historical fluctuations in our performance and to achieve, maintain, or grow profitability;

the rate and degree of market acceptance and adoption of our tests and testing services and other anticipated trends in our industry;

our competitive advantages and our ability to remain competitive, particularly if the testing markets continue to expand, and competition becomes more acute;

our ability to continue to expand our test menu and introduce other improvements to our tests;

our continued ability to offer affordable pricing for our tests, to maintain the low internal costs of our business model, and to record acceptable margins on our sales;

the timing and our ability to develop our drug candidates, to satisfy the U.S. Food and Drug Administration’s, or FDA’s, regulatory requirements, and to commercialize our drug candidates;

the anticipated progress of our drug candidate development programs, including whether our ongoing and potential future clinical trials will achieve clinically relevant results;

our ability to generate data and conduct analyses to support the regulatory approval of our drug candidates and our plans to pursue discussions with regulatory authorities, and the anticipated timing, scope and outcome of related regulatory actions or guidance;

the success of our competitors’ research and development efforts for drug candidates seeking to treat similar or the same indication as our drug candidates;

our ability to strengthen our existing base of customers by maintaining or increasing demand from these customers;

our ability to grow and diversify our customer base;

our reliance on a limited number of suppliers and their ability to adapt to possible disruptions in their operations;

our use of our laboratory facilities and our ability to adapt in the event we need to relocate or in the event any of our facilities are damaged or rendered inoperable;

our plans for future sales and marketing efforts;

advancements in technology by us and our competitors;

our use of technology and ability to prevent security breaches; unauthorized use or disclosure of health information, personal information, or sensitive personal information; loss of data; and other disruptions;

our ability to effectively manage any growth we may experience, including expanding our infrastructure, developing increased efficiencies in our operations, and hiring additional skilled personnel in order to support any such growth;

developments with respect to U.S. and foreign laws and regulations applicable to our business, and our ability to comply with these regulations, and the results or potential liability associated with disclosure pursuant to any voluntary disclosure process by and between us and applicable regulatory agencies and bodies;

our ability to effectively respond to the results of payor audits and government audits, such as our currently pending HRSA audit;

our ability to prevent errors in interpreting the results of our tests so as to avoid product liability and professional liability claims;

our ability to obtain and maintain coverage and adequate reimbursement for our tests and to manage the complexity of billing and collecting such reimbursement;

the state of the U.S. and foreign healthcare markets, including the role of governments in the healthcare industry, generally, pressures or incentives to reduce healthcare costs while expanding individual benefits, and the impact of general uncertainty in the U.S. healthcare regulatory environment;

our ability to attract, retain, and motivate key scientific and management personnel;

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our ability to obtain and maintain protection of our trade secrets, licensed intellectual property, patent rights, and other intellectual property rights and to not infringe the rights of others;

our expectations regarding inflation and our future expense levels and our ability to appropriately forecast and plan our expenses;

our expectations regarding our future capital requirements and our ability to obtain additional capital if and when needed; and

the impact of the above factors and other future events on the market price of our common stock.

These forward-looking statements are subject to a number of risks and uncertainties, including, among others, those described under Item 1A, “Risk Factors” and elsewhere in this report. Moreover, we operate in a competitive and rapidly evolving industry, and new risks emerge from time to time. It is not possible for us to predict all of the risks we may face, nor can we assess the impact of all factors on our business or the extent to which any factor or combination of factors could cause actual results to differ from our expectations. In light of these risks and uncertainties, the forward-looking events and circumstances described in this report may not occur, and actual results could differ materially and adversely from those described in or implied by any forward-looking statements we make. Although we have based our forward-looking statements on assumptions and expectations that we believe are reasonable, we cannot guarantee future results, levels of activity, performance or achievements, or other future events. As a result, forward-looking statements should not be relied on or viewed as predictions of future events, and this report should be read with the understanding that our actual future results, levels of activity, performance and achievements, or other future events may be materially different than what we currently expect.

The forward-looking statements in this report speak only as of the date of this document, and except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this report to conform these statements to actual results or to changes in our expectations.

We qualify all of our forward-looking statements by this cautionary note.

We own registered or unregistered trademark rights to Fulgent®, Picture Genetics®, BEACON®, INFORMDX®, LUMERA®, and our company name and logo. Any other service marks, trademarks and trade names appearing in this report are the property of their respective owners. We do not use the ® or ™ symbol in each instance in which one of our trademarks appears in this report, but this should not be construed as any indication that we will not assert our rights thereto to the fullest extent under applicable law.

Fulgent Genetics, Inc., together with its subsidiaries and affiliated professional corporations with which the Company has a management services arrangement, are collectively referred to in this Annual Report on Form 10-K as the “Company,” “Fulgent,” “we,” “us,” and “our.”

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