5/1/2026

speaker
Operator
Conference Operator

Greetings. Welcome to Fulgent Genetics first quarter 2026 conference call and webcast. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to Lauren Sloan, Investor Relations. Thank you. You may begin.

speaker
Lauren Sloan
Investor Relations

Good morning and welcome to Fulgent's first quarter 2026 financial results conference call. On the call are Ming Hsieh, Chief Executive Officer, Paul Kim, Chief Financial Officer, and Brandon Perthes, Chief Commercial Officer. The company's press release discussing the financial results is available on the investor relations section of the company's website, ir.fulgentgenetics.com. A replay of this call will be available shortly after the call concludes on the investor relations section of the company's website. Management's prepared remarks and answers to your question on today's call will contain forward-looking statements. These forward-looking statements represent management's estimates based on current views, expectations, and assumptions, which 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 from those described in the forward-looking statements. The company assumes no obligation to update any of the forward-looking statements it may make today to reflect actual results or changes in expectations. Listeners should not rely on any forward-looking statements as predictions of future events and should listen to management's remarks today with the understanding that actual events, including the company's actual future results, may be material different than what is described in or implied by these forward-looking statements. Please review the more detailed discussion related to these forward-looking statements, including the discussions of some of the risk factors that may cause results to differ from those described in the forward-looking statements contained in the company's filings and with the Securities and Exchange Commission, including the previously filed 10-K for the year ended December 31, 2025, and subsequently filed reports which are available on the company's investor relations website. Management's prepared remarks, including discussion of non-GAAP profit, loss, operating expense, margin, earnings, and earnings per share, and adjusted EBITDA, contain financial measures not prepared in accordance with accounting principles generally accepted in the United States, or GAAP. Management has presented these non-GAAP financial measures because it believes they may be useful to investors for various reasons. but these measures should not be viewed as a substitute for or superior to the company's financial results prepared in accordance with GAAP. Please see the company's press release discussing its financial results for the first quarter 2026 for more information, including the description of how the company calculates non-GAAP income and loss, non-GAAP earnings and loss per share, non-GAAP gross profit, non-GAAP gross margin, non-GAAP operating profit and loss, and margin in adjusted EBITDA. and a reconciliation of these financial measures to income and loss, earnings and loss per share, and operating margin, the most directly comparable GAAP financial measures. 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, including equity-based compensation, tax effects, acquisition-related items, and potential impairment, any of which may be material, is unavailable on a forward-looking basis without unreasonable effort, and the probable significance of those items cannot be predicted. With that, I'd now like to turn the call over to Ming. Please go ahead.

speaker
Ming Hsieh
Chief Executive Officer

Thank you, Lauren. I will start with some comments on our two business lines. Then Brendan will review our product and go-to-market updates for our left-free service business. And Paul will conclude with the financials and outlook before we take your questions. I am pleased with our first quarter results in our laboratory service business and the momentum in our therapeutic development business. In Q1, we also successfully completed acquisition of Barcode Diagnostics and Strata DX, which contributed our strong first quarter results. as we had anticipated. In the laboratory service business, we are seeing that the investment in AI and digital pathology solutions are continuing to work at an accelerated pace, offering new and expanded opportunities for growth and improved operating leverage in the future. And as of today, with our in-house developer platform, EzeoPath, We are approximately 100% official across all our cases. We also accelerated progress on our therapeutic development pipeline in the fourth quarter and expect to continue progress this year. Starting with our first clinical candidate, FID07, advanced through phase two with 46 patients enrolled. Last week, we announced that our abstract on the phase two trial of FID-07 was selected by ASCO as a rapid oral presentation with head and neck cancer track session. The phase two trial enrollment of FID-07 closed on time on December 29th, 2025. We are encouraged by the early efficacy and safety data FID-07 combined with cetacumab demonstrate meaningful anti-cancer activities and the favorable tolerability profile that at both levels for the second line treatment of recurrent metastatic head and neck sarcoma cell carcinoma. We anticipate having end of phase two meeting with FDA for the second half of this year. I hope to enter into a phase three registration trial for the treatment of recurrent or metastatic head and neck, sequela cell carcinoma patients in the first half of 2027. We are encouraged by our clinical trial progress achieved so far and believe entering into the phase three registration trial will further increase the probability of the success of the commercialization FID-07 for the treatment of recurrence or metastatic head and neck sequela cell carcinoma patients who currently have very few effective treatment options. Our second clinical candidate, FID-022, is progressing to phase one dose escalation with the third dose level successfully completed. And the fourth dose escalation is ongoing. We expect to finish the study and determine the maximum tolerance dose level later this year. FID-022, it is nanoencapsulated for the treatment of solid tumors, including , colon, pancreatic, ovarian, and the bile duct cancers. Overall, I'm pleased with the progress we have made in the first quarter. Our pharma R&D efforts are progressing faster, better, and more cost-effectively than planned. We look forward to present our detailed findings from our phase two study on FID07 at this year's ASCO meeting. We believe that We execute our strategic initiatives and are in a strong financial position to execute our strategies. We are pleased to reiterate our popular revenue guidance for 2026. We are adjusting our non-GAAP EPS and cash balance guidance to reflect the cash returned to shareholders. with our stock repurchase program and the resulting reduction in the number of our previously forecast outstanding shares. I would like to thank our employees, partners, and stockholders for your hard work, loyalty, and a strong quarter. We look forward to further progress in 2026. I will now turn the call over to Brandon Purdy, our Chief Commercial Officer, to talk more about our laboratory service business. Brandon?

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