Fulgent Genetics, Inc.

Greetings. Welcome to Fulgent Genetics fourth quarter 2025 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 during the conference, 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.

Good morning and welcome to the Fulgent fourth quarter and fiscal year 2025 financial results conference call. On the call are Ming Hsieh, Chief Executive Officer, Paul Kim, Chief Financial Officer, and Brandon Perthuis, 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 questions 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 statement. The company assumes no obligation to update any of the forward-looking statements it makes 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 included in the company's actual future results may be materially different than what is described in or implied by these forward-looking statements. Please review the more detailed discussions 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 with the Securities and Exchange Commission, including the previously filed 10-K for the year ended December 31, 2024. and subsequently filed reports, which are available on the company's investor relations website. Management's prepared remarks, including discussions of profit, loss, margin, earnings, and earnings per share, 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 fourth quarter 2025 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 and 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 is unavailable on a forward-looking basis without unreasonable effort. With that, I'd now like to turn the call over to Ming. Please go ahead.

Thank you, Lauren. I'm pleased with the progress we have made this year as we execute our strategic objectives in both our laboratory services and the therapeutic development business. In 2025, the laboratory services business sustained momentum as we delivered growth and executed our strategic and the product innovation roadmap. We have implemented the best-in-class technology across our platform, and the investment we have made in digital pathology and AI are paying off. We are seeing the advantage of moving to digital and using AI-enabled workflow with increased quality, turnaround time, and throughput. We have launched our own proprietary imaging management system, EZO Plus, which integrates the best in-class AI tools developed in-house, giving us even greater control in the technology services. We also accelerated our product innovation in 2025 with the launch of RNA integrated whole genome sequencing and ultra-rapid whole genome sequencing. The investment in AI and digital pathology solutions, coupled with our innovations across our laboratory service platform, we deliver for revenue and the margin improvement in 2025. We see the first half of 2026 in a transition period as our business adjusted to the impact from our largest customer moving significant volume in-house. We believe our technology platform will continue to get stronger and the strategic investment and the innovations we have made will continue to work at an accelerated pace, offering new and expanded opportunity for growth and improve the operating leverage in future. We also accelerate the progress of our therapeutic development pipeline in 2025 and expect continued progress this year. Starting with our first clinical candidate, FID07, advanced through the phase two with 46 patients enrolled. The trial enrollment closed on time on December 29, 2025. We are encouraged by the early efficacy and the safety data. FID-07 combined with cetazimab demonstrate the meaningful anti-cancer efficacy and the favorable, tolerable profile at both dose levels for the second-line treatment of recurrent metastasis, head, neck, and squamous cell carcinoma. Phase III, protocol development. is long ongoing with the trial initiative planned as early as the first half of 2027. This year, we are trying to submit a request to FDA in the second quarter of 2026 and the hope to have a phase two meeting with FDA in the third quarter of 2026. We anticipate presenting our interim findings at the ESCO in June, 2026, and expect a full data readout by the second half of 2027. We are encouraged by our clinical trial progress achievement so far, and we believe entering into the phase three registration trial will further increase the probability of the success of commercialization FID-07 for the treatment of recurrence metastatic head and neck zirconia cell carcinoma patient currently having very few effective treatment options. Our second clinical candidate, FID022, is progressing for the phase one dose escalation with the first dose level successfully completed at the end of December 2025. And the second dose level successfully completed on January 28, 2026. The third dose level begins on February 2, 2026. We expect to finish the study and determine the maximum tolerable dose level later this year. FID-022 is a nanoencapsulated SN38A for the treatment of solid tumors, including potentially colon, pancreatic, oren, and the bile duct cancers. Overall, I'm pleased with the progress we have made this year. Our pharma R&D efforts are progressing faster, better, and more cost-effective than planned. Additionally, our laboratory services business is greatly beneficial from our investment of AI technology, which marks our service more efficient and precise. And although our revenue of 2025 slightly short of our updated expectation, we are exceeded our non-GAAP EPS guidance and proud of the progress we have made and believe our business is intact. As we look to 2026, we believe that the first half of the year will be impacted by our largest customer moving a significant volume of his work in-house. But also the strategic initiative we have made may help offset this impact over the long term. I would like to thank our employees, partners, and the stakeholders for your hard work and the loyalty. in a great quarter of our business. We look forward to further progress in 2026. I will now turn the call over to Brandon Perthes, our Chief Commercial Officer, to talk more about our laboratory services business. Brandon?