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Fulgent Genetics, Inc.
8/1/2025
Greetings and welcome to the Fulgiginetics Q2 2025 conference call-in webcast. At this time, all participants are in listen-only mode. If anyone should require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the phone presentation, and you may be placed into question queue at any time by pressing star one on your telephone keypad. As a reminder, this conference is being recorded. It's now my pleasure to introduce your host, Lauren Sloan, Investor Relations. Please go ahead.
Thank you, and good morning, and welcome to the Fulgiginetics Q2 2025 Financial Results conference call. On the call today are Ming She, Chief Executive Officer, Paul Kim, Chief Financial Officer, and Brandon Perthews, Chief Commercial Officer. The company's press release discussing the financial results is available on the Investor Relations section of the company's website, .Fulgiginetics.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 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 or 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 discussion 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 of 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 GAP. Management has presented these non-GAP 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 GAP. Please see the company's press release discussing the financial results for second quarter 2025 for more information, including the description of how the company calculates non-GAP income, loss, non-GAP earnings, loss per share, non-GAP gross profit, non-GAP gross margin, non-GAP profit and loss, and margin and adjusted EBITDA, and a reconciliation of these financial measures to income or loss, earnings and loss per share, and operating margin, the most directly comparable GAP financial measures. With that, I now turn the call over to Ming. Please go ahead.
Thank you, Lauren. Good morning, and thank you for joining our call today. I will start with some comments on the second quarter of 2025 and our two business lines. Then Brandon will review our product and go to the market updates for our laboratory services business, and Paul will conclude with the financials and outlook before we take your questions. We are pleased with our second quarter results. We have shown both sequential and -over-year growth in laboratory services. We are pleased with the momentum we are seeing as we move through 2025. Our therapeutic development pipeline is on track. Our first clinical canopy, FID07, is progressing through a phase two clinical trial in combination with the setaximine. In patients with recurring or metastasis, type MEG, sequelae cell carcinoma, with 32 patients enrolled and dosed, we expect to complete patient enrollment by the end of this year with a data readout in 2026. We project the clinical trial of phase two to be approximately $30 million over a multi-year period. Our second clinical canopy, FID022, the beginning of phase one trial and the first group of patients has been enrolled. FID022 is a nanomecathelic enzyme 38 for treatment of solid tumor, including potentially colon, pancreatic, ovarian, and bile duct cancers. We continue to expect clinical trial costs of phase one trial of FID022 to be approximately $8 million. I am encouraged by the continued progress with our clinical pipeline and the potential for both FID07 and FID022. These drug candidates address heavily pretreated patients with very few options left. I hope we will be able to provide alternatives to further their lives. Our anticipated cost for these programs is very reasonable and we believe our investment will be rewarded. Overall, I am pleased with our progress in the first half of the year in both our business areas. We will continue to be in a strong financial position to execute our strategy. I would like to thank our employees, partners, and stakeholders for your hard work and loyalty in every quarter for our business. We look forward to further progress in the second half of 2025. I now turn over to Brandon Pertius, our Chief Commercial Officer, to talk more about the laboratory services business. Brandon?
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