Fulgent Genetics, Inc.

Greetings, and welcome to the Folger Genetics Q3 2024 conference call and 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 formal presentation. 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 turn the call over to your host, Melanie Solomon, Investor Relations. Please go ahead.

Good morning, and welcome to the Fulgen Third Quarter 2024 Financial Results Conference Call. On the call today are Ming Hsieh, 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, 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'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 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 and the forward-looking statements contained in the company's filing with the Securities and Exchange Commission, including the previously filed 10-K for the year ended December 31, 2023, 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 in accordance with GAAP. Please see the company's press release discussing its financial results for the third quarter of 2024 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 third quarter and our two business lines. Then Brandon will review our product and go-to-market updates. For our luxury services business, in the third quarter, and Paul will conclude with the financial and the outlook before we take any questions. We are pleased with our results in the third quarter, with $71.7 million of total revenue. Third quarter revenue of $71.7 million was driven by our momentum in precision diagnostics, particularly with product and oncology. We were pleased with our work from the second to third quarter of 2014 in all three areas of our laboratory service business. And we see good momentum ahead as we continue to invest in reproductive health, testing and seeing benefits of those investments. In our therapeutic This year, we initiated a Phase II clinical trial of FID-007 in combination with the psychopathy test in patients with HNFCC and EROS that began in the second quarter. So far, we have eight patients in this trial, and we've seen pretty good results from this initial patient. We expect to enroll approximately 40 patients at the worst site and to complete enrollment in early 2026. We continue to estimate the total patient throughput trial cost of the Phase II trial to be approximately $10 million. We continue to act once our second drug candidate, FID-022, a nano-decapsulator SN38, in preclinical study towards an invest digital new drug application at the end of this year. All have observed FIDO2 has shown have a superior efficacy over Irene teaching in various demographic models including COVID, ALDA, psoriasis, pancreatic cancers, in our preclinical studies. No significant unexpected toxicity were observed in both RAS and the monkey GLP toxicity studies. In addition, we also made a significant advancement in development of antibody drug conjugates using our novel patient linker and the payload platform technology. In pre-cognitive studies, we observed that our ADC would have a better efficacy over different tumors with a broad range of target antigen expression levels compared with some of the best ADC benchmarks on the market in pre-clinical settings. In the meantime, ADC-online could now work target using our novel platform technology are also being prepared with the goal of generating leading candidates for clinical studies. As you remember, all our drug candidates were funded with our novel nanoencapsulation technology, which included over 30 issues of active patterns and active pattern applications. the therapeutic platform designed to improve therapeutic windows for pharmacogenetics and the existing cancer drugs. Overall, we believe we have a good strategy with both our core laboratory services business and our therapeutic development business. We see momentum in our core business, which we believe will continue to grow, potentially strengthening our business model and fueling our therapeutic initiatives. We continue to maintain a strong balance, which will execute our strategy. I would like to thank our employees, partners, and stakeholders for your hard work and loyalty in a very good third quarter for our business. We hope to have a strong close to the year. Now, I turn the call over to Brandon Perkins, our Chief Commercial Officer, to talk more about our laboratory services business results in the third quarter. Brandon?