Fulgent Genetics Q3 2026 net loss widens to $13.2M
Full-year guidance keeps revenue at $330.0 million to $340.0 million and puts expected non-GAAP loss at approximately $46.0 million to $50.0 million.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
Fulgent Genetics, Inc. (FLGT) reported third-quarter 2026 revenue of $90.4 million, up approximately 8% year over year. Net loss attributable to Fulgent was $13.2 million, or $0.48 per share, versus $6.6 million, or $0.21 per share, a year earlier. Non-GAAP loss was $2.4 million, or $0.09 per share, versus non-GAAP income of $4.5 million; GAAP gross margin was 35.3%, versus 42.2%, and adjusted EBITDA was a $7.5 million loss, versus $0.7 million income.
Cash, cash equivalents, restricted cash and investments in marketable securities totaled $652.4 million at September 30, 2026. For full-year 2026, Fulgent maintains revenue guidance of $330.0 million to $340.0 million and now expects a non-GAAP loss of approximately $46.0 million to $50.0 million and cash, cash equivalents, restricted cash and investments in marketable securities of approximately $630.0 million. The outlook reflects 4.1 million shares repurchased and $64.1 million of repurchase spending through September 30; the cash estimate assumes $13 million in capital purchases, no further near-term repurchases and $21 million in therapeutic-development spending.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Moderate pointThird-quarter revenue rose approximately 8% year over year to $90.4 million.
Negative
- Moderate pointNet loss attributable to Fulgent was $13.2 million, versus $6.6 million a year earlier.
- Moderate pointGAAP gross margin was 35.3%, versus 42.2% a year earlier.
- Moderate pointAdjusted EBITDA was a $7.5 million loss, versus $0.7 million income a year earlier.
Filing Explained
The updated presentation adds interim Phase 2 FID-007 results: a
8-K Event Classification
Key Figures
Key Terms
Non-GAAP financial measures financial
Adjusted EBITDA financial
Non-GAAP gross margin financial
nanoencapsulated nano-drug delivery platform technical
Earnings Snapshot
For full-year 2026, revenue of $330.0 million to $340.0 million; non-GAAP loss of approximately $46.0 million to $50.0 million; and cash, cash equivalents, restricted cash and investments in marketable securities of approximately $630.0 million.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
How much revenue and what loss did FLGT report for Q3 2026?
What is FLGT's 2026 financial guidance?
What interim FID-007 results did Fulgent report?
AI-generated analysis. How Rhea-AI works. Not financial advice.
!
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact Name of Registrant as Specified in Charter)
(State or other jurisdiction of incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
(Address of Principal Executive Offices) |
(Zip Code) |
(
(Registrant’s telephone number, including area code)
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:
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)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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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 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
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. ☐
Item 2.02 Results of Operations and Financial Condition.
On November 5, 2026, Fulgent Genetics, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal quarter ended September 30, 2026. A copy of the Company’s press release containing this information is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
Item 7.01 Regulation FD Disclosure.
From time to time, the Company presents and/or distributes slides and presentations to the investment community to provide updates and summaries of its business. On November 5, 2026, the Company updated its investor presentation, which is available on the Investor Relations section of the Company’s website at http://ir.fulgentgenetics.com. This presentation is also furnished as Exhibit 99.2 to this Current Report on Form 8-K.
The information in Items 2.02 and 7.01, including Exhibits 99.1 and 99.2, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference into any registration statement or other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
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Description |
99.1 |
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Press Release of Fulgent Genetics, Inc., dated November 5, 2026 |
99.2 |
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Corporate Presentation of Fulgent Genetics, Inc. |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: November 5, 2026 |
FULGENT GENETICS, INC. |
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By: |
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/s/ Paul Kim |
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Name: |
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Paul Kim |
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Title: |
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Chief Financial Officer |
Exhibit 99.1
Fulgent Reports Third Quarter 2026 Financial Results
EL MONTE, CA, November 5, 2026 — Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent,” or the “Company”), a technology-based company with a well-established laboratory services business and a therapeutic development business, today announced financial results for its third quarter ended September 30, 2026.
Third Quarter 2026 Results:
Non-GAAP income (loss), non-GAAP income (loss) per share, adjusted EBITDA income (loss), non-GAAP gross profit and margin, and non-GAAP operating income (loss) and margin, are described below under “Note Regarding Non-GAAP Financial Measures” and are reconciled to the most directly comparable GAAP financial measure, GAAP income (loss), GAAP gross profit and margin, and GAAP operating income (loss) and margin, in the accompanying tables.
Ming Hsieh, Chairman of the Board of Directors and Chief Executive Officer, said, “We are encouraged by the momentum in our therapeutics pipeline, with both FID-007 and FID-022 using our nano-drug delivery platform. In our laboratory services business, we continue to integrate AI into our workflow as utilization scales and reliability substantially increases. We expect to continue to expand our AI portfolio to drive further improvements to efficiency and quality.”
Paul Kim, Chief Financial Officer, said, “We are pleased with our third quarter results, driven by the improvement in our collection rates. We made great progress to address the billing system issue and remain confident in our outlook for the remainder of the year.”
Outlook:
For the full year 2026, Fulgent expects:
For the full year 2026, Fulgent now expects:
*Cash expenditures may be higher or lower than currently estimated due to a variety of factors and circumstances, including as a result of the Company’s ongoing stock repurchase program, or other expenditures outside the ordinary course of business, including M&A. This number assumes capital purchases of $13 million, no further near-term repurchases under the stock repurchase program, and spend on the therapeutic development business of $21 million. The timing and amount of any future repurchases pursuant to the stock repurchase program will depend on a variety of factors, including the market price of Fulgent’s common stock, general market and economic conditions, and other factors Fulgent’s board of directors may deem relevant.
Conference Call Information
Fulgent will host a conference call for the investment community today at 4:30 PM ET (1:30 PM PT) to discuss its third quarter 2026 results. The call may be accessed through a live audio webcast in the Investor Relations section of the Company’s website, http://ir.fulgentgenetics.com. An audio replay will be available at the same location.
Note Regarding Non-GAAP Financial Measures
Certain information set forth in this press release and/or to be discussed on the Company’s earnings call, including non-GAAP income (loss), non-GAAP income (loss) per share, adjusted EBITDA income (loss), non-GAAP gross profit and margin, and non-GAAP operating income (loss) and margin, are non-GAAP financial measures. Fulgent believes this information is useful to investors because it provides a basis for measuring the performance of the Company’s business, excluding certain income or expense items that management believes are not directly attributable to the Company’s operating results. Fulgent defines non-GAAP income (loss) as net income (loss) calculated in accordance with accounting principles generally accepted in the United States of America, or GAAP, plus amortization of intangible assets, plus impairment loss, plus equity-based compensation expenses, plus acquisition-related costs, which include one-time banker fees, legal, valuation, due diligence, and closing costs, plus acquisition-related severance, plus or minus the non-GAAP tax effect, and plus or minus other charges or gains, as identified, that management believes are not representative of the Company’s operations. The non-GAAP tax effect was calculated by excluding from the GAAP provision the impact of the amortization of intangible assets, impairment loss, equity-based compensation expenses, acquisition-related costs, and acquisition-related severance. Fulgent defines adjusted EBITDA income (loss) as GAAP income (loss) plus or minus interest (expense) income, plus or minus provisions (benefits) for income taxes, plus depreciation and amortization, plus equity-based compensation expenses, plus insurance expense related to transferable tax credits, plus impairment loss, plus acquisition-related costs, plus acquisition-related severance, and plus or minus other charges or gains, as identified, that management believes are not representative of the Company’s operations. Fulgent defines non-GAAP gross profit as gross profit calculated in accordance with GAAP plus equity-based compensation included in cost of revenue as shown in the table below.
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Fulgent defines non-GAAP gross margin by taking non-GAAP gross profit and dividing it by GAAP revenue. Fulgent defines non-GAAP operating profit (loss) by taking GAAP operating profit (loss) and adding equity-based compensation expense, amortization of intangible assets, impairment of intangible assets, acquisition-related costs, and acquisition-related severance. Non-GAAP operating margin is calculated by taking non-GAAP operating profit (loss) and dividing it by GAAP revenue. Fulgent may continue to incur expenses similar to the items added to or subtracted from the GAAP financial measures, and, accordingly, the exclusion of these items in the presentation of these non-GAAP financial measures should not be construed as an implication that these items are unusual, infrequent or non-recurring. Management uses these non-GAAP financial measures along with the most directly comparable GAAP financial measure in evaluating the Company’s operating performance and for internal planning and budgeting. Non-GAAP financial measures should not be considered in isolation from, or as a substitute for, financial information presented in conformity with GAAP, and non-GAAP financial measures as reported by Fulgent may not be comparable to similarly titled metrics reported by other companies. The Company does not provide reconciliations of forward-looking non-GAAP measures to the most directly comparable GAAP measures because the information necessary to calculate such reconciliations is unavailable on a forward‑looking basis without unreasonable effort. This is due to the inherent difficulty of forecasting the timing and amounts of items that would be included in the GAAP measures, including, but not limited to, equity‑based compensation, tax effects, acquisition‑related items, and potential impairments, any of which could be material. The Company is also unable to predict the probable significance of such items.
About Fulgent
Fulgent is a technology-based company with a well-established laboratory services business and a therapeutic development business. Fulgent’s laboratory services business includes technical laboratory and testing services and professional interpretation of laboratory results by licensed physicians. Fulgent’s therapeutic development business is focused on developing product candidates for treating a broad range of cancers using a novel nanoencapsulation and targeted therapy platform designed to improve the therapeutic window and pharmacokinetic profile of new and existing cancer drugs. The Company aims to transform from a genomic diagnostic business into a fully integrated precision medicine company.
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 are often identified by words such as “anticipate”, “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “guidance,” “intend,” “may,” “plan,” “project,” “should,” “target,” “will,” and similar expressions. Examples of forward-looking statements in this press release include statements about, among other things: future performance; guidance, including guidance regarding expected quarterly and annual financial results, revenue, GAAP loss, non-GAAP loss and related per share figures, and cash, cash equivalents, restricted cash, and investments in marketable securities; potential improvements in margins; evaluations and judgments regarding the strength of the Company’s business; the potential benefits of the continued integration of AI into the Company’s laboratory business and expansion of the Company’s AI portfolio; any references (express or implied) to the potential benefits of the StrataDx and Bako Diagnostics acquisitions, including any potential or expected revenue and whether the revenue will offset loss of other revenues; the Company’s ability to remediate operational issues relating to the transition of its billing and revenue cycle management systems; the Company’s continued and future research and development efforts, including any implications that the results of earlier clinical trials will be representative of, or consistent with later
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clinical trials; and the Company’s identification and evaluation of opportunities and its ability to capitalize on opportunities, capture market share, or expand its presence in certain markets; and the Company’s ability to continue to grow its business.
Forward-looking statements are statements other than historical facts and relate to future events or circumstances or the Company’s future performance, and they are based on management’s current assumptions, expectations, and beliefs concerning future developments and their potential effect on the Company’s business. These forward-looking statements are subject to a number of risks and uncertainties, which may cause the forward-looking events and circumstances described in this press release to not occur, and actual results to differ materially and adversely from those described in or implied by the forward-looking statements. These risks and uncertainties include, among others, risks regarding: the market potential for, and the rate and degree of market adoption of, the Company’s tests; its ability to maintain turnaround times and otherwise keep pace with rapidly changing technology; the Company’s ability to maintain the low internal costs of its business model; the Company’s ability to maintain an acceptable margin; risks related to volatility in the Company’s results, which can fluctuate significantly from period to period; risks associated with the composition of the Company’s customer base, which can fluctuate from period to period and can be comprised of a small number of customers that account for a significant portion of the Company’s revenue; dependence on a limited number of customers, including risks that any such customer may further reduce, delay, or internalize testing volumes; risks related to the Company’s acquisitions, including Bako and StrataDx, such as integration challenges, costs, and the Company’s ability to realize expected benefits on anticipated timelines; the Company’s level of success in obtaining coverage and adequate reimbursement and collectability levels from third-party payors for its tests and testing services, including its ability to manage and to remediate billing software implementation issues and claims processing delays; the Company’s level of success in establishing and obtaining the intended benefits from partnerships, strategic investments, joint ventures, acquisitions, or other relationships; the success of the Company’s development efforts, including the Company’s ability to progress its candidates through clinical trials on the timelines expected; the outcome of the Company’s interactions with the FDA and other regulators, including whether FDA feedback on the Company’s proposed Phase 3 trial of FID-007 will require changes to the trial design that delay its commencement or increase its cost; the Company’s ability to successfully develop, validate, and deploy artificial intelligence applications in its laboratory operations, including the risk that such applications may not perform in clinical use as they have in internal testing, and evolving laws and regulations applicable to the use of artificial intelligence in diagnostic testing; the Company’s compliance with the various evolving and complex laws and regulations applicable to its business and its industry; the Company’s ability to obtain expected tax refunds on the timelines expected; and the Company’s ability to protect its proprietary technology and intellectual property. As a result of these risks and uncertainties, forward-looking statements should not be relied on or viewed as predictions of future events.
The forward-looking statements made in this press release speak only as of the date of this press release, and the Company assumes no obligation to update publicly any such forward-looking statements to reflect actual results or changes in expectations, except as otherwise required by law.
The Company’s reports filed with the U.S. Securities and Exchange Commission, or the SEC, including its annual report on Form 10-K for the fiscal year ended December 31, 2025, filed with the SEC on February 27, 2026, and the other reports it files from time to time, including subsequently filed annual, quarterly and current reports, are made available on the Company’s website and on the SEC’s website at www.sec.gov upon their filing with the SEC. These reports contain more information about the Company,
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its business and the risks affecting its business, as well as its results of operations for the periods covered by the financial results included in this press release.
Investor Relations Contact:
The Blueshirt Group
Lauren Sloane, lauren@blueshirtgroup.com
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FULGENT GENETICS, INC. |
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Condensed Consolidated Balance Sheet Data |
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September 30, 2026, and December 31, 2025 |
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(in thousands) |
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September 30, 2026 |
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December 31, 2025 |
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ASSETS: |
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Cash and cash equivalents |
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$ |
86,787 |
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$ |
50,193 |
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Investments in marketable securities |
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565,502 |
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655,153 |
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Accounts receivable, net |
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62,494 |
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84,762 |
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Property, plant, and equipment, net |
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110,738 |
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112,549 |
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Other assets |
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253,408 |
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310,868 |
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Total assets |
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$ |
1,078,929 |
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$ |
1,213,525 |
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LIABILITIES & EQUITY: |
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Accounts payable, accrued liabilities and other liabilities |
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$ |
94,221 |
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$ |
106,810 |
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Total stockholders’ equity |
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984,708 |
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1,106,715 |
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Total liabilities & equity |
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$ |
1,078,929 |
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$ |
1,213,525 |
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FULGENT GENETICS, INC. |
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Condensed Consolidated Statement of Operations Data |
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Three and Nine Months Ended September 30, 2026, and 2025 |
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(in thousands, except per share data) |
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(unaudited) |
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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Revenue |
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$ |
90,412 |
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$ |
84,069 |
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$ |
246,939 |
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$ |
239,335 |
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Cost of revenue (1) |
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58,465 |
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48,557 |
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167,823 |
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141,042 |
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Gross profit |
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31,947 |
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35,512 |
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79,116 |
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98,293 |
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Operating expenses |
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Research and development (1) |
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13,636 |
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13,860 |
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42,366 |
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39,735 |
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Selling and marketing (1) |
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15,606 |
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11,642 |
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43,055 |
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32,393 |
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General and administrative (1) |
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22,761 |
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23,335 |
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77,640 |
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75,018 |
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Amortization of intangible assets |
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2,491 |
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2,025 |
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7,125 |
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|
6,005 |
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Impairment of intangible assets |
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— |
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— |
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2,172 |
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— |
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Total operating expenses |
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54,494 |
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50,862 |
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172,358 |
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153,151 |
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Operating loss |
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(22,547 |
) |
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(15,350 |
) |
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(93,242 |
) |
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(54,858 |
) |
Interest income |
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8,554 |
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7,874 |
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23,609 |
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|
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23,983 |
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Interest expense |
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(7 |
) |
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(28 |
) |
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(83 |
) |
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(59 |
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Impairment of equity securities |
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— |
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— |
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— |
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(9,926 |
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Other (expense) income, net |
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(43 |
) |
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(5 |
) |
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5 |
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109 |
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Total other income, net |
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8,504 |
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7,841 |
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23,531 |
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14,107 |
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Loss before income taxes |
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(14,043 |
) |
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(7,509 |
) |
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(69,711 |
) |
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(40,751 |
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Benefit from income taxes |
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(704 |
) |
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(683 |
) |
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(1,379 |
) |
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(2,770 |
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Net loss from consolidated operations |
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(13,339 |
) |
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(6,826 |
) |
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(68,332 |
) |
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(37,981 |
) |
Net loss attributable to noncontrolling interests |
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187 |
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|
218 |
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|
824 |
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|
886 |
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Net loss attributable to Fulgent |
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$ |
(13,152 |
) |
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$ |
(6,608 |
) |
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$ |
(67,508 |
) |
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$ |
(37,095 |
) |
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Net loss per common share attributable to Fulgent: |
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||||
Basic |
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$ |
(0.48 |
) |
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$ |
(0.21 |
) |
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$ |
(2.34 |
) |
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$ |
(1.21 |
) |
Diluted |
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$ |
(0.48 |
) |
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$ |
(0.21 |
) |
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$ |
(2.34 |
) |
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$ |
(1.21 |
) |
Weighted-average common shares: |
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||||
Basic |
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27,662 |
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|
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30,749 |
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28,837 |
|
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30,708 |
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Diluted |
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27,662 |
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30,749 |
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28,837 |
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30,708 |
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(1) Equity-based compensation expense was allocated as follows: |
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Cost of revenue |
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$ |
885 |
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$ |
1,697 |
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$ |
3,431 |
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|
$ |
5,214 |
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Research and development |
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|
2,953 |
|
|
|
3,247 |
|
|
|
9,626 |
|
|
|
10,060 |
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Selling and marketing |
|
|
536 |
|
|
|
736 |
|
|
|
1,746 |
|
|
|
2,337 |
|
General and administrative |
|
|
3,746 |
|
|
|
4,037 |
|
|
|
11,831 |
|
|
|
12,695 |
|
Total equity-based compensation expense |
|
$ |
8,120 |
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|
$ |
9,717 |
|
|
$ |
26,634 |
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|
$ |
30,306 |
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FULGENT GENETICS, INC. |
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Non-GAAP Income (Loss) Reconciliation |
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Three and Nine Months Ended September 30, 2026, and 2025 |
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(in thousands, except per share data) |
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|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Net loss attributable to Fulgent |
|
$ |
(13,152 |
) |
|
$ |
(6,608 |
) |
|
$ |
(67,508 |
) |
|
$ |
(37,095 |
) |
Amortization of intangible assets |
|
|
2,491 |
|
|
|
2,025 |
|
|
|
7,125 |
|
|
|
6,005 |
|
Impairment loss (1) |
|
|
— |
|
|
|
— |
|
|
|
2,172 |
|
|
|
9,926 |
|
Equity-based compensation expense |
|
|
8,120 |
|
|
|
9,717 |
|
|
|
26,634 |
|
|
|
30,306 |
|
Acquisition-related costs (2) |
|
|
— |
|
|
|
90 |
|
|
|
2,649 |
|
|
|
387 |
|
Acquisition-related severance (3) |
|
|
— |
|
|
|
— |
|
|
|
647 |
|
|
|
— |
|
Non-GAAP tax effect |
|
|
134 |
|
|
|
(703 |
) |
|
|
(1,269 |
) |
|
|
(1,466 |
) |
Non-GAAP (loss) income attributable to Fulgent |
|
$ |
(2,407 |
) |
|
$ |
4,521 |
|
|
$ |
(29,550 |
) |
|
$ |
8,063 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per common share attributable to Fulgent: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic |
|
$ |
(0.48 |
) |
|
$ |
(0.21 |
) |
|
$ |
(2.34 |
) |
|
$ |
(1.21 |
) |
Diluted |
|
$ |
(0.48 |
) |
|
$ |
(0.21 |
) |
|
$ |
(2.34 |
) |
|
$ |
(1.21 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Non-GAAP (loss) income per common share attributable to Fulgent: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic |
|
$ |
(0.09 |
) |
|
$ |
0.15 |
|
|
$ |
(1.02 |
) |
|
$ |
0.26 |
|
Diluted |
|
$ |
(0.09 |
) |
|
$ |
0.14 |
|
|
$ |
(1.02 |
) |
|
$ |
0.26 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted average common shares: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic |
|
|
27,662 |
|
|
|
30,749 |
|
|
|
28,837 |
|
|
|
30,708 |
|
Diluted |
|
|
27,662 |
|
|
|
31,312 |
|
|
|
28,837 |
|
|
|
30,952 |
|
(1) Consists of non-cash charges related to (i) a 2026 impairment of an intangible asset previously acquired through a business combination and (ii) a 2025 impairment of a prior investment.
(2) Consists of acquisition-related costs related to the acquisitions of Bako and StrataDx for the nine months ended September 30, 2026.
(3) Consists of one-time severance payments to the former CEO & CFO of Bako and StrataDx for the nine months ended September 30, 2026.
|
|
|
FULGENT GENETICS, INC. |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Non-GAAP Adjusted EBITDA Reconciliation |
|
|||||||||||||||
Three and Nine Months Ended September 30, 2026, and 2025 |
|
|||||||||||||||
(in thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
|||||
Net loss attributable to Fulgent |
|
$ |
(13,152 |
) |
|
$ |
(6,608 |
) |
|
$ |
(67,508 |
) |
|
$ |
(37,095 |
) |
Interest income, net |
|
|
(8,547 |
) |
|
|
(7,846 |
) |
|
|
(23,526 |
) |
|
|
(23,924 |
) |
Benefit from income taxes |
|
|
(704 |
) |
|
|
(683 |
) |
|
|
(1,379 |
) |
|
|
(2,770 |
) |
Depreciation and amortization |
|
|
6,816 |
|
|
|
6,038 |
|
|
|
20,492 |
|
|
|
18,011 |
|
Equity-based compensation expense |
|
|
8,120 |
|
|
|
9,717 |
|
|
|
26,634 |
|
|
|
30,306 |
|
Insurance expense related to transferable tax credits |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
283 |
|
Impairment loss |
|
|
— |
|
|
|
— |
|
|
|
2,172 |
|
|
|
9,926 |
|
Acquisition-related costs |
|
|
— |
|
|
|
90 |
|
|
|
2,649 |
|
|
|
387 |
|
Acquisition-related severance |
|
|
— |
|
|
|
— |
|
|
|
647 |
|
|
|
— |
|
Adjusted EBITDA |
|
$ |
(7,467 |
) |
|
$ |
708 |
|
|
$ |
(39,819 |
) |
|
$ |
(4,876 |
) |
|
|
|
FULGENT GENETICS, INC. |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Non-GAAP Operating Margin |
|
|||||||||||||||
Three and Nine Months Ended September 30, 2026, and 2025 |
|
|||||||||||||||
(in thousands, except percentages) |
|
|
|
|
|
|
|
|
|
|
|
|
||||
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2026 |
|
|
2025 |
|
|
2026 |
|
|
2025 |
|
||||
Revenue |
|
$ |
90,412 |
|
|
$ |
84,069 |
|
|
$ |
246,939 |
|
|
$ |
239,335 |
|
Cost of revenue |
|
|
58,465 |
|
|
|
48,557 |
|
|
|
167,823 |
|
|
|
141,042 |
|
Gross profit |
|
|
31,947 |
|
|
|
35,512 |
|
|
|
79,116 |
|
|
|
98,293 |
|
Gross margin |
|
|
35.3 |
% |
|
|
42.2 |
% |
|
|
32.0 |
% |
|
|
41.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Equity-based compensation included in cost of revenue |
|
|
885 |
|
|
|
1,697 |
|
|
|
3,431 |
|
|
|
5,214 |
|
Non-GAAP gross profit |
|
|
32,832 |
|
|
|
37,209 |
|
|
|
82,547 |
|
|
|
103,507 |
|
Non-GAAP gross margin |
|
|
36.3 |
% |
|
|
44.3 |
% |
|
|
33.4 |
% |
|
|
43.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Operating expenses |
|
|
54,494 |
|
|
|
50,862 |
|
|
|
172,358 |
|
|
|
153,151 |
|
Operating loss |
|
|
(22,547 |
) |
|
|
(15,350 |
) |
|
|
(93,242 |
) |
|
|
(54,858 |
) |
Operating margin |
|
|
-24.9 |
% |
|
|
-18.3 |
% |
|
|
-37.8 |
% |
|
|
-22.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Equity-based compensation included in operating expenses |
|
|
7,235 |
|
|
|
8,020 |
|
|
|
23,203 |
|
|
|
25,092 |
|
Amortization of intangible assets |
|
|
2,491 |
|
|
|
2,025 |
|
|
|
7,125 |
|
|
|
6,005 |
|
Impairment of intangible assets |
|
|
— |
|
|
|
— |
|
|
|
2,172 |
|
|
|
— |
|
Acquisition-related costs |
|
|
— |
|
|
|
90 |
|
|
|
2,649 |
|
|
|
387 |
|
Acquisition-related severance |
|
|
— |
|
|
|
— |
|
|
|
647 |
|
|
|
— |
|
Non-GAAP operating expenses |
|
|
44,768 |
|
|
|
40,727 |
|
|
|
136,562 |
|
|
|
121,667 |
|
Non-GAAP operating loss |
|
$ |
(11,936 |
) |
|
$ |
(3,518 |
) |
|
$ |
(54,015 |
) |
|
$ |
(18,160 |
) |
Non-GAAP operating margin |
|
|
-13.2 |
% |
|
|
-4.2 |
% |
|
|
-21.9 |
% |
|
|
-7.6 |
% |
|
|
|
Founded in 2011 | Located in El Monte, CA | NASDAQ:FLGT Investor Presentation November 5, 2026
Disclaimer Forward-Looking Statements and Market Data This presentation contains forward-looking statements, which are statements other than those of historical facts and which represent the estimates and expectations of Fulgent Genetics, Inc. (the “Company” or “Fulgent”) about future events based on current views and assumptions. Examples of forward-looking statements made in this presentation include, among others, those related to long-term upside or value, management of risk, anticipated growth and positioning, addressable market estimates, the Company’s mission, vision and strategies, the success of its business model and strategy, anticipated future revenue and guidance, evaluations and judgments regarding the Company’s business, products, technologies, competitive landscape, scalability, plans regarding development and launch of potential future products, and any businesses the Company may seek to acquire or has acquired or has invested in or may seek to invest in, including statements regarding Fulgent Pharma Holdings, Inc. (“Fulgent Pharma”), Inform Diagnostics, CSI Laboratories, Bako and StrataDx acquisitions, and any potential synergies, or transformation of the Company’s business, long-term visions and strategies, the completion of the transition of the Company's billing and revenue cycle management system, the clinical development of Fulgent Pharma’s pipeline and related statements and assumptions regarding development timelines, any potentially accelerated pathway for regulatory approval, the potential safety and efficacy of the nanodrug delivery platform and any related therapeutic candidates, the potential market size for these candidates and platforms and the value of available data, including genomic data, the Company’s research and development efforts, including any implications that the results of earlier clinical trials will be representative or consistent with later clinical trials, the expected timing or timing of enrollment for these clinical trials or that interim or preliminary data will be representative of the final data or results of these trials, and guidance regarding the Company’s future performance and results of operations, including any cash or cash equivalent resource projections. The Company’s views and assumptions on which these forward-looking statements are based may prove to be incorrect. As a result, matters discussed in any forward-looking statements are subject to risks, uncertainties and changes in circumstances that may cause actual results to differ materially from those discussed or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those implied by forward-looking statements are disclosed under “Risk Factors” and “Management's Discussion and Analysis of Financial Condition and Results of Operations” in the Company’s reports filed with the Securities and Exchange Commission ("SEC"), including its annual report on Form 10-K filed on February 27, 2026, and other reports it files from time to time. Because of these factors, you should not rely upon forward-looking statements as predictions of future events. The forward-looking statements in this presentation are made only as of the date hereof, and, except as required by law, the Company assumes no obligation to update any forward-looking statements in the future. The Company’s reports filed with the SEC, including its annual report on Form 10-K for the year ended December 31, 2025, filed with the SEC on February 27, 2026, and the other reports it files from time to time, including subsequently filed annual, quarterly and current reports, are made available on the Company’s website upon their filing with the SEC. These reports contain more information about the Company, its business and the risks affecting its business, as well as its results of operations for the periods covered by the financial results included in this presentation. This presentation also includes market data and forecasts with respect to the industry in which the Company operates. In some cases, the Company relies upon and refers to market data and certain industry forecasts that have been obtained from third-party surveys, market research, consultant surveys, publicly available information and industry publications that the Company believes to be reliable. These data and estimates involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. Non-GAAP Financial Measures This presentation contains certain supplemental financial measures that are not calculated pursuant to U.S. generally accepted accounting principles (“GAAP”). These non-GAAP measures are in addition to, not a substitute for or superior to, measures of financial performance prepared in accordance with GAAP. A reconciliation of non-GAAP measures to GAAP measures is contained in this presentation. Fulgent believes this information is useful to investors because it provides a basis for measuring the performance of the Company’s business, excluding certain income or expense items that management believes are not directly attributable to the Company’s operating results. The Company does not provide reconciliations of forward-looking non-GAAP measures to GAAP measures, due to the inability to predict the amount and timing of impacts outside of the Company's control on certain items, particularly items related to equity-based compensation, acquisition-related items, tax effects and potential impairments, among other items, which could be material. Reconciling such items would require unreasonable efforts.
Leadership Team Seasoned legal and privacy professional with nearly two decades of legal experience Privacy Law Specialist; Certified Information Privacy Manager; Certified Information Privacy Professional and an Advisory Board Member with the International Association of Privacy Professionals J.D. from Duke University School of Law Brandon Perthuis Chief Commercial Officer Natalie Prescott General Counsel & Chief Privacy Officer Ming Hsieh Chief Executive Officer Dr. Harry Gao Lab Director and Chief Scientific Officer James Xie President and Chief Operating Officer Paul Kim Chief Financial Officer Extensive experience leading genetic testing commercialization programs since 2003 Previously VP of Sales and Marketing of the Medical Genetics Laboratory at Baylor College of Medicine Prior to Baylor, held senior roles at PerkinElmer, Inc. and Spectral Genomics, Inc. B.S. in Biomedical Science Responsible for managing all global operations, product vision and product engineering Served as an SVP of Cogent Systems, Inc. B.A. in Engineering, M.S. in Industrial Engineering and an M.S. in Computer Science Experienced financial leader and Certified Public Accountant Previously CFO of Cogent Systems, Inc. B.A. in Economics from University of California at Berkeley Previously Lab Director at City of Hope Clinical molecular genetics training fellowship and post-doctoral fellowship at Harvard Medical School M.S. in Immunology, and M.D. and Ph.D. in Microbiology, Immunology, and Medical Genetics Experienced operational leader, entrepreneur and philanthropist Previously CEO, President, and Chairman of Cogent Systems, Inc. Member of the National Academy of Engineering; Fellow of the National Academy of Inventors; Trustee of USC Dr. Ray Yin President, Pharma Founder & CEO, ANP Technologies, Inc. Former Team Leader of Nanobiotechnology for Chem/Bio Defense, U.S. Army Research Laboratory Holder of 46 drug delivery/detection patents Ph.D. in Chemistry, University of Southern California
About Fulgent We are a premier global, technology-based genomic testing company focused on transforming patient care in oncology, infectious and rare diseases, and reproductive health. Since integrating with our therapeutic development business, Fulgent is also developing drug candidates for treating a broad range of cancers using a novel nanoencapsulation and targeted therapy platform. By merging our fields of expertise, we aim to become a fully integrated precision medicine company. Mission Develop flexible and affordable diagnostics and therapeutics that improve the everyday lives of those around us. Core Values Innovation Customer Service and Commitment Quality and Efficiency Our People Strategy Leverage our proprietary technology platform for broad application Further clinical/regulatory program for Pharma Operational excellence Disciplined M&A
Investment Highlights Scaled diagnostics platform + clinical-stage oncology pipeline + strong balance sheet 1 Scaled, In-House Diagnostics Platform Proprietary NGS chemistry and software; 18,400+ single-gene tests and 900+ panels, with 100% of volume processed in-house 2 AI-Driven Approach to Genetic Testing An industry leader in automating diagnostic workflows to improve diagnostic accuracy across the integrated platform 3 Differentiated Clinical Pipeline FID-007 and FID-022 are derived from same proprietary Clean Chemo™ delivery platform patented and fully owned by Fulgent; potential near-term clinical catalysts 4 IP-Rich Technology Patented drug delivery platform and fully owned, proprietary lab IP from gene probes to Eziopath, Fulgent's in-house AI imaging system 5 Balance Sheet Flexibility Strong balance sheet to support investments in diagnostic platform and pharmaceutical pipeline, with $1.1B in total assets $330-340M FY 2026 revenue guidance ~$630M Expected cash & investments in marketable securities for FY 2026 $21M FY 2026 Expected Non-GAAP R&D and G&A spend on therapeutic development
Laboratory Services
3 Well-positioned to execute on a growth strategy that includes organic and inorganic initiatives, including: Transformational acquisitions Scaling partnerships Acquisitions with a strategy of short- and long-term ROI, tangible synergies, and efficient capital deployment 1 2 $90M Q3 Revenue 8% Q3 Year-over-Year Revenue Increase 18,400+ GENES | 900+ PANELS CUSTOMIZABLE OFFERINGS Positioned for Growth Proprietary technology platform allows for rapid scaling of a broad, flexible test menu Next-generation sequencing (NGS) platform complemented with growing portfolio of emerging testing technologies with a focus on oncology
Precision Diagnostics Laboratory Services Anatomic Pathology BioPharma Services Reproductive Health Oncology / Liquid Biopsy Rare Disease Neurogenetics Spatial Phenotyping Exome / Genome sequencing RNA sequencing Single Cell sequencing Dermatopathology Gastrointestinal (GI) Genitourinary (GU) GSP Platform & Capabilities Across 3 Categories 8
Target Market Opportunity Cancer Diagnostics Early Detection / Liquid Biopsy Reproductive Health BioPharma Services Genes & Panels Tumor Profiling Known Mutation Newborn Genetics Hereditary Cancer Carrier Screens Genomic Testing Sequencing Service Infectious Disease BiolSpatialogy 9
What Sets Fulgent Apart? Technology Platform A New Approach to NGS Proprietary probes and engineered chemistry Comparison and suppression algorithms Comprehensive analytics powered by AI and ML Extensive Test Menu Leads to a Broader Test Menu 18,400+ single-gene tests (1) 900+ panels Whole Genome and Exome Flexibility enables custom tests for any genes or conditions Preset panels have grown 350% since IPO in 2016 Superior Cost Structure A Better Cost Structure Lab efficiencies, automation, and scale have translated to a sustainable cost structure Partnerships create leverage with sales and marketing Process 100% of volume without the need for outsourcing Rapid Turnaround Time Represents genes covered by single-gene tests. 10
Patients and Providers Research Portal …Provides a Multitude of Advantages Broad test menu Ability to rapidly develop and launch new tests Customizable test offerings Lower costs per billable test High efficiency AI & Proprietary Technology Platform Differentiated Technology... Engineered genetic biochemistry, including reagents and probes Data suppression and comparison algorithms Adaptive learning software Automated reporting Web Services for: Clinical Workflow for: Cancer Carrier Exome Genome Methylation Mitochondrial Rent-a-lane Sequencing Services: WGS/WES RNA Oncology Single Cell Pipeline Services: Curation Tools Curation Content Curation Cloud: Report Editor Curation Warehouse Dry Lab Service Data Analysis Germline Somatic Custom Lab Workflow: Wet Lab Auto Lab Record Management: Patient Record BioBank FulgentDB Fulgent and Picture Websites Benefit Analysis Mito Other 11
Recent Traction with: Hereditary Cancer Cardiovascular Genetics Reproductive Health Neurodegenerative Genetics Newly launched ultra rapid whole genome sequencing Aggressively expanding sales and commercial organization Wide Array of Technologies Services Include: Flow cytometry Cytogenetic analysis Fluorescence in-situ hybridization (FISH) Immunohistochemistry Molecular genetics Consultations in hematopathology and surgical pathology NGS Broad Capabilities Broad Capabilities Breast pathology Gastrointestinal pathology Dermatopathology Urologic pathology Neuropathology Managed care contract network and physician relationships leveraged to provide diagnostic products and services complementary to Fulgent’s portfolio Expansive geographic presence with multiple CLIA-licensed laboratories across the United States Next Generation Sequencing Opportunities Specialized Oncology Testing Comprehensive Anatomic Pathology Services
Expanding the Integrated Diagnostics Platform Acquisition: Bako & StrataDx Adjusted Purchase Price: $56.4 Million Closed: March 17, 2026 AI Integration: Leverages Eziopath, Fulgent's proprietary AI, to automate pathology workflows and improve diagnostic accuracy. Drives commercial synergies: Nearly doubles pathology sales force headcount and introduces specialized dermatopathology expertise. Test Menu Expansion: Adds premier national pathology assets, including PCR tests that optimize costs and offer rapid results. Expands national client and laboratory footprint: Addition of CLIA and CAP certified and NY licensed laboratories in Georgia (Bako) and Massachusetts (StrataDx).
Scalable and Affordable Menu for Customers Large Panel Small Panel Focus Panel Single-Gene / Custom Comprehensive Panel Average Sales Price / Test Whole Genome Whole Exome Clinical Exome GREATER OFFERINGS THAN MANY LEADING COMPETITORS CNV+ MANY COMPETITORS DO NOT OFFER Flow Cytometry FISH Histopathology Cytogenetics Molecular
NGS Testing – Offerings Site-Specific Testing Known Mutation Focus (50 Genes) Comprehensive (154 Genes) Somatic Cancer Panels 20 Panels Repeat Expansion 18,400+ Genes Single Gene 800+ Panels Customizable Panels Disease Panels Exome and Whole Genome Genomic Tests
NGS Testing – Germline Oncology Test Menu Fulgent Focus Cancer Panels Fulgent Comprehensive Cancer Panels Customizable: Add additional cancer genes or panels at no charge Genes: 50 Methods: NGS & Del/Dup Coverage: 99% at 50x Del/Dup ≥ 1 Exon TAT: 2 – 3 Weeks Customizable: Add additional cancer genes or panels at no charge Methods: NGS & Del/Dup Genes: 154 Coverage: 99% at 50x Del/Dup ≥ 1 Exon TAT: 2 – 3 Weeks Focused Comprehensive
Oncology Testing Platforms Expansive heme and solid tumor menu STAT testing available - PML/RARA <1 day turnaround time CD138 cell enrichment for PCM 3-5 day turnaround time 225+ stains Platform agnostic Roche, Agilent, and Leica IHC Three levels of service – Tech, Global, Consultative PD-L1 - Various IVD platforms and indications <1-2 day turnaround time Hematology and solid tumor menu Extensive single gene menu NGS Solid tumor liquid biopsy NGS offering 5-7 day turnaround time Oncology and constitutional >20% abnormality detection rate Mitogen stimulation/dual culture DSP30 (detection of B-cell disorders) Interleukin 4 for plasma cell myeloma Phytohemagglutinin and Interleukin 2 (detection of T-cell disorders) Children’s Oncology Group approved 5-7 day turnaround time FISH Histology Cytogenetics Flow Cytometry Molecular 10-color platform Comprehensive panel design High-sensitivity for paroxysmal nocturnal hemoglobinuria Expert analysis and interpretation 12-24 hour turnaround time
NGS Testing – Ultra Rapid Whole Genome Covers > 20,000 genes Fast turnaround (38-48 hours for preliminary report) Change medical management for up to 87% of babies* Designed for critically ill infants in the NICU/PICU to rapidly diagnose genetic disorders Single nucleotide variants Repeat Expansions Exon deletions/duplications Mitochondrial alterations Genome-wide deletions/duplications Comprehensive detections: TRIO, DUO, or Proband +/- RNA-seq Regions of homozygosity * PMID 34089648 - Analysis limited to DNA analysis of SNVs and CNVs.
The Focus Carrier screen is a pan-ethnic screen that looks for pathogenic mutations known to cause autosomal recessive and X-linked disorders Gene Count: 30 The Ashkenazi Jewish carrier screens for pathogenic carrier variants known to cause recessive genetic disorders Gene Count: 61 The ACOG/ACMG panel screens for common genetic disorders seen in the general population Gene Count: 6 One of the largest panels available for those seeking the most comprehensive testing option Gene Count: 787 The Expanded Panel screens for more than 400 recessive and X-linked conditions that covers people of all ethnic backgrounds Gene Count: 427 NGS Testing – Panel Deep Dive NGS of entire genes, not just hotspots Deletion and duplication analysis Proprietary algorithms for pseudogenes TAT: 2 Weeks Beacon Carrier Screening Beacon ACOG / ACMG Guidelines Panel Beacon Ashkenazi Jewish Panel Beacon Focus Panel Beacon Expanded Panel Beacon787 Panel Comprehensive Beacon Carrier Screening Tests
Therapeutic Development
Source: ACS/SEER 2026 (sarcoma: 13,910 soft tissue + 4,110 bone). NSCLC and ampullary values are derived. Potential Market Opportunity for FID-007 & FID-022 INITIAL INDICATIONS SUBSEQUENT INDICATIONS Colorectal 158,850 Head & Neck 72,770 Breast 324,580 ~200,000 Pancreatic 67,530 Sarcoma 18,020 Ampullary ~1,800 Estimated new cancer cases in the US per year NSCLC
Innovative Clean ChemoTM Platform: Developing A New Potential Line of Defense Against Cancer Clean Chemo™ Nano-Drug Candidates FID-007 and FID-022 Immunotherapy Targeted Therapy IO & Clean ChemoTM Combination Therapy ✓ Solid tumors Clean ChemoTM Monotherapy ✓ RM/HNSCC ✓ HPV+ RM/HNSCC ✓ mCRC ✓ Solid tumors Targeted & Clean ChemoTM Combination Therapy ✓ mCRC ✓ Solid tumors
A first-in-human study of FID-007 monotherapy in advanced solid tumors (NCT03537690,N=50) demonstrated: a manageable safety profile without any grade ≥3 peripheral neuropathy An ORR of 45% in a subset of 11 heavily pre-treated patients with R/M HNSCC FID-007 and FID-022 Nanoparticles Background of FID-007 and FID-022 Nanoencapsulated nano-drug delivery platform formulation designed to promote tumor penetration and retention Observed PK was a rapid and more extensive distribution to tissue/tumor with lower exposures of unbound paclitaxel when compared to solvent-based paclitaxel Enhanced chemotherapy agent as backbone for mono- or combination therapy The nano-drug delivery platform technology is covered by over 20 issued patents and over 10 active patent applications worldwide as of December 31, 2025. A first-in-human study of FID-022 monotherapy in advanced solid tumors (NCT06694480): Dose escalation ongoing
Pipeline Overview Drug Candidate Therapy Indication Pre-Clinical Phase 1 Phase 2 Phase 3 Recent & Anticipated Milestones FID-007 ✓ Interim Ph2 data in June 2026 ✓ End of Ph2 meeting with FDA in 3Q 2026 Combo – Cet RM/HNSCC Mono HPV+ RM/HNSCC Combo – ADC mCRC Combo – IO Solid Tumors FID-022 ✓ Dosing completed for first 4 dose levels Determine maximum tolerated dose level in 2H 2027 Mono Solid Tumors Mono mCRC Combo – ADC mCRC Potential FDA approval strategy uses 505(b)(2) studies, which may shorten the clinical trial process and accelerate the timeline to commercialization. Developing a next-generation ADC technology platform that could deliver better efficacy across tumors with a broad range of target antigen expression levels, compared to current ADC benchmarks. *Shading is not intended to represent precise progress within a phase
FID-007: Tumor Response & Treatment Duration Best Overall Change in Tumor Size of Target Lesions from Baseline Responders Arm A (N=12) Arm B (N=14) Median DOR (95% CI, mo) 7.36 (1.87, NE) 5.98 (2.17, NE) Median TTR (Min, Max, mo) 1.77 (1.68, 7.29) 1.84 (1.64, 3.61) Arm A Arm B Duration of Response & Time to Response 25
FID-007: Best Overall Response Arm A (N=21) Arm B (N=21) Total (N=42) BOR n (%) CR 2 (9.5) 5 (23.8) 7 (16.7) PR 10 (47.6) 9 (42.9) 19 (45.2) SD 4 (19.0) 6 (28.6) 10 (23.8) PD 3 (14.3) 1 (4.8) 4 (9.5) NE 2 (9.5) 0 2 (4.8) ORR n (%) 12 (57.1) 14 (66.7) 26 (61.9) DCR n (%) 16 (76.2) 20 (95.2) 36 (85.7)
ITT population Arm A (N=22) Arm B (N=24) Total (N=46) Median PFS (95% CI, mo) 6.74 (4.17, 12.81) 5.75 (5.42, 9.20) 6.67 (5.42, 9.20) Overall Survival (ITT Population) 1-year OS 63.4% Progression-Free Survival (ITT Population) FID-007: Progression-Free and Overall Survival 27
* 1 Grade 5 TRAE in Arm B (pneumonia) FID-007: Summary of Adverse Events Adverse event category, n (%) Arm A (N=22) Arm B (N=24) Total (N=46) Any TEAEs 20 (90.9) 24 (100) 44 (95.7) Any TEAEs of ≥ CTCAE Grade 3 15 (68.2) 22 (91.7) 37 (80.4) Any TEAEs related to FID-007 20 (90.9) 24 (100) 44 (95.7) Any TEAEs related to cetuximab 18 (81.8) 21 (87.5) 39 (84.8) Any serious TEAEs 10 (45.5) 13 (54.2) 23 (50.0) Any TRAEs leading to dose modification of FID-007 11 (50.0) 19 (79.2) 30 (65.2) Any TRAEs leading to withdrawal of FID-007 0 2 (8.3) 2 (4.3) Any TRAEs leading to death* 0 1 (4.2) 1 (2.2)
In an ongoing Phase 2, open-label trial and as of June 2026, FID-007 demonstrated encouraging clinical activity when combined with cetuximab in patients with R/M HNSCC. FID-007: Interim Clinical Data EFFICACY ORR 61.9 % mDOR 7.4 mo 95% CI: 3.7–11.1 mPFS (ITT) 6.7 mo 95% CI: 5.4–9.2 1-Year OS 63.4 % mOS not yet mature SAFETY Manageable safety profile with no infusion-related reactions or grade ≥3 peripheral neuropathy PHASE 3 STUDY 125 mg/m2 dose is proposed for Phase 3 study. 29
FID-022-001 Clinical Update Dose level 1, 2, 3, & 4 are completed 1. Bayesian Optimal Interval Design, a type of model-assisted dose finding design used to determine the maximum tolerated dose. FID-022: FIH Study Design (BOIN1) L1: 20 mg/m L5: 100 mg/m L4: 80 mg/m L3: 60 mg/m L2: 40 mg/m L6:120 mg/m Dose escalation BOIN design N≥3 each dose level Total ≤ 24 Monotherapy: Infusion on Days 1 and 8 of every 21-day cycle Simulate possible dose de-escalation 2 2 2 2 2 2 Cycle 1 Cycle 2 D1 D8 D15 D22 D29 D36 D43 D50 D57 Cycle 3 Days:
Financials
Summary of Financial Performance $90M Revenue in Q3 2026 $14M Last Twelve Months (LTM) Operating Cash Flow as of Q3 2026 +5% year-over-year ($ in millions) 8% increase year-over-year Note: All figures are rounded.
($ in millions) ($ in millions) ($ in millions) Fulgent defines non-GAAP gross profit as gross profit calculated in accordance with GAAP plus equity-based compensation included in cost of revenue, and Fulgent defines non-GAAP gross margin by taking non-GAAP gross profit and dividing it by GAAP revenue. See appendices for Non-GAAP reconciliations of these figures. Note: All figures are rounded. Financial Performance: Revenue and Gross Margin
YTD 2026 Financial Performance Across Segments Non-GAAP metric excludes equity-based compensation, impairment loss, amortization of intangible assets, acquisition-related costs, acquisition-related severance, and impairment of intangible assets. See Appendices for Non-GAAP reconciliations of these figures. Note: All figures are rounded.
YTD Revenue by Category Therapeutic development for drug candidates still in pre-commercial stage. Note: All figures are rounded. Total Revenue1 $ in millions Precision Diagnostics Anatomic Pathology BioPharma Services $142.2 $79.4 $17.7 $239.3 $123.5 $103.5 $19.9 $246.9 -13% YoY +30% YoY +13% YoY YTD Q3 2025 YTD Q3 2026
2026 Financial Guidance Expected cash, cash equivalents, and investments in marketable securities of approximately $630 million as of December 31, 20262 This has accounted for the impact on weighted-average outstanding shares for shares repurchased up to date. Cash expenditures may be higher or lower than currently estimated due to a variety of factors and circumstances, including as a result of the Company’s ongoing stock repurchase program, or other expenditures outside the ordinary course of business, including M&A. This number further assumes capital purchases of $13.0 million, no further repurchases under the stock repurchase program, and spend on the therapeutic development business of $21.0 million. The timing and amount of any future repurchases pursuant to the stock repurchase program will depend on a variety of factors, including the market price of Fulgent’s common stock, general market and economic conditions and other factors Fulgent’s board of directors may deem relevant. Note: All figures are rounded. Key Metrics METRIC LOW HIGH Total Revenue $330M $340M YoY Growth +2.3% +5.4% Non-GAAP EPS1 $(1.65) $(1.75) Expected Revenue Breakdown ($M) CATEGORY LOW HIGH Precision Diagnostics $161 $165 Anatomic Pathology 146 150 BioPharma Services 23 25 Total Revenue $330 $340
Appendix
Balance Sheet
Non-GAAP Financial Adjustments Acquisition-related costs incurred in Q2 2025 were adjusted as the acquisition of ANP Technologies, Inc. was signed and closed during Q3 2025. Prior reporting included these costs in general and administrative operating expenses but did not remove them for Non-GAAP reporting.
Non-GAAP Financial Adjustments by Segment
Parenting Screens adults to determine their carrier status for recessive genetic disorders Newborn Screens newborns for genes associated with various severe genetic conditions Wellness Screens adults for genetic variants that indicate disease risk PD Aware Assesses genetic risk for Parkinson's Disease Consumer Initiated Tests – Picture Genetics Targeting the Large Consumer Market with Picture Genetics Launched in 2019 with significant growth amid COVID-19 A consumer-focused offering that merges clinical utility with accuracy of an accredited lab Extends Fulgent’s NGS capabilities to a broader market Validated by successfully scaling to hundreds of thousands of tests performed within months for COVID-19, after receiving an EUA Genetic tests utilizes complete sequencing (vs genotyping) by NGS analysis for better, more accurate results Patient-friendly with easy to use “order from home” model – no doctor office visits or insurance necessary, though many tests are eligible for reimbursement Select full service offering that includes analysis and genetic counseling support PGx Pharmacogenetic test that provides genetic insights on drug response
FID-007: Demographics and Baseline Disease Characteristics Platinum = carboplatin or cisplatin Arm A N=22 (%) Arm B N=24 (%) Age (years) Median (min, max) 64.5 (49, 81) 66.0 (45, 79) Gender Male 17 (77.3) 20 (83.3) Female 5 (22.7) 4 (16.7) Ethnicity Hispanic or Latino 1 (4.5) 8 (33.3) Non-Hispanic or Latino 21 (95.5) 16 (66.7) ECOG PS 0 4 (18.2) 10 (41.7) 1 18 (81.8) 14 (58.3) Primary Tumor Location Oral cavity 12 (54.5) 13 (54.2) Oropharynx 8 (36.4) 8 (33.3) Larynx 2 (0.9) 2 (8.3) Paranasal sinuses 0 1 (4.2) Prior ICI Yes 22 (100) 24 (100) Prior Platinum Tx Yes 15 (68.2) 15 (62.5) Prior Systemic Tx Locally advanced (LA) only 8 (36.4) 7 (29.2) Recurrent / Metastatic (R/M) only 7 (31.8) 10 (41.7) Both LA and R/M 7 (31.8) 7 (29.2) HPV (p16) Status Positive, Oropharynx 7 (31.8) 6 (25.0) All other 15 (68.2) 18 (75.0) Enrollment is completed as of Clinical Cut-Off Date April 16, 2026 46 patients were randomized and received ≥ 1 dose of FID-007 (ITT and safety populations) 42 patients were efficacy-evaluable 42
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