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Fulgent Genetics, Inc.
5/2/2025
reminder, this conference is being recorded. It's now my pleasure to turn the call over to Melanie Solomon, Investor Relations. Please go ahead.
Thank you, Kevin. Good morning, and welcome to the Fulgen First Quarter 2025 Financial Results Conference Call. On the call are Ming Shai, 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, ir.fulgengenetics.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 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 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 31st, 2024, and subsequently filed reports which are available on the company's investor relations website. Management's prepared remarks, including discussions of 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 first quarter 2025 for more information, including the description of how the company calculates non-GAAP income or loss, earnings or loss per share, non-GAAP gross profit, non-GAAP gross margin, non-GAAP operating profit or loss, and margin and adjusted EBITDA, and a reconciliation of these financial measures to income or loss, earnings or loss per share, and operating margin, the most directly comparable GAAP financial measures. With that, I'd now like to turn the call over to Ming.
Thank you, Melanie. Good morning, and thank you for joining our call today. I will start with some comments on the first quarter of 2025 and our two business lines. Then Brandon will review our product and go-to-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 first quarter results, having shown year-over-year growth in laboratory service, and we are looking, seeing great, good fundamentals in 2025. Our therapeutic development pipeline is on track. For our first clinical candidate, FID-07, Our Phase II clinical trial in combination with ceftoxanine in patients with recurrent or metastatic head, neck, sycomas, cell carcinoma is progressing well. With 17 patients receiving treatment and 23 enrolled, we'll continue to enroll patients throughout this year. We'll continue to project the clinical trial cost of Phase II to be approximately $10 million over multiple year period. Our second clinical candidate, FID-022, is set to begin phase one trials over next few weeks. FID-022 is nanoencapsulated SN38 for treatment for solid tumors, including potentially colon, pancreatic, ovarian, and the bile duct cancers. We continue to expect the clinical trial cost of Phase I-1B trial for FID-022 to be approximately $8 million. I am encouraged by the continued progress with our clinical pipeline and the potential for both FID-07 and FID-022. We are targeting heavily pre-treated patients with few options left. I hope we'll be able to provide additional treatment options to further their lives. We are anticipating the cost of this program is very reasonable and we believe our investment will be rewarded. As a reminder, our drug candidates were familiar with our novel nanoencapsulation technology. which include many issued or active patent or active patent applications. And with a therapy platform designed to improve therapeutic windows and the pharmacokinetics profile for both new and existing cancer drugs. Overall, I'm pleased with our strong start to the year in our core laboratory services business. and the progress we're making with our therapeutic development pipeline. We continue to be in strong financial position to execute our strategy. I would like to thank our employees, partners, and stakeholders for your hard work and loyalty in a great quarter for our business. We look forward to further progress in 2025. I will now turn over the call to Brandon Perdue, our Chief Commercial Officer to talk more about our laboratory services business, right, Nick?
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