7/30/2026

speaker
Operator
Conference Operator

Greetings and welcome to the Folger Genetics second quarter 2026 conference call and webcast. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. You may be placed into question queue at any time by pressing star 1 on your telephone keypad. As a reminder, this conference is being recorded. If anyone should require operator assistance, please press star 0. It's now my pleasure to turn the call over to Lauren Sloan, Investor Relations. Lauren, please go ahead.

speaker
Lauren Sloan
Investor Relations

Good afternoon and welcome to Fulgent's second quarter 2026 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 may make today to reflect actual results or changes in expectations. Listeners should not rely on any forward-looking statements as predictions of the future and should listen to management's remarks today with the understanding that actual events, including the company's actual future results, may be material or 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 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 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 discussions 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 second quarter of 2026 for more information, including the description of 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 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 impairments, any 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 Brandon will review our product and go-to-market update for our laboratory service business. and Paul will conclude with the financial and other before we take your questions. I'm pleased with the momentum in our therapeutic development business as we're progressing on our clinical pipeline. In June, we presented the finding from the phase two trials data for FID-07. which demonstrate encouraging activity in recurrent or metastatic head and neck sarcoma cell carcinoma. Fulgine has taken a differentiated approach with FID-07. It's a novel nanoencalcified paclitexel can be developed with Fulgine's Clean Chemo platform. The platform is designed to reduce toxicity typically associated with conventional chemotherapy while maintaining or improving efficacy. A profile Fosgen believes is preferable in combination oncology arrangements. With phase two complete and the encouraging data now presented publicly at the ESCO, We are focused on the next milestone. We have confirmed the end of phase two meeting with the FDA, which is scheduled later this summer. We believe the phase two we have generally provide a strong foundation going into the FDA's discussion. Our phase three study is in preparation, and we hope to enter into a phase three registration trial for the treatment of recurrent or metastatic head and neck cecumar cell carcinoma patients in the first half of 2027. We are encouraged by our clinical trial progress achieved so far, and I believe entering into the phase three registration trial will further increase the probability of the success of the commercialization FIVD-07 for treatment of recurrent metastatic head and neck sequela cell carcinoma patients who currently have very few effective treatment options. We also want to reiterate our position on partnerships. We have financial strength to advance through the face-to-face with our own, but we are open to collaboration discussions. We intend to approach those conversations with a focus on partners who bring both resources and long-term strategic alignment. Our second clinical candidate, FID022, is progressing to the phase one dose escalation with the fourth dose level successfully completed. We expect to determine the maximum tolerated dose level later this year. FIV-022 is a nanoencapsulated SN38 for the treatment of solid tumors, including potentially colon, pancreatic, ovarian, and bile duct cancers. Please note that both IVD-07 and 022 are derived from the same proprietary clean chemo delivery platform Patent and fully owned by Sogen. Similar to FID-07, FID-022 can also be used in ORIs on cost drug combinations. In the laboratory service business, we continue to see our AI and digital pathology solution work at an accelerated pace and continue to expand our AI portfolio. drive the innovation across our business and seeing sustained demand and consistent testing warning. We are also managing the transition of our billing and revenue cycle management system. This transition has caused delays in billing and the process of claims and impact our ability to collect at our historical rates. and the reduced amount of revenue we are able to recognize from the test we have performed. Addressing revenue cycle many things is our top operational priority and we are making progress. I would like to thank our employees, partners and stakeholders for your hard work and the loyalty. I'm now return the call over to Brandon Perthuis. Our chief commercial officer to talk more about our laboratory service business. Brandon.

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