Fulgent Genetics, Inc.

Hello, and welcome to the Fulton Genetics Q4 and Fiscal Year 2022 Earnings Conference Call and Webcast. If anyone should require operator assistance, please press star zero on your telephone keypad. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Melanie Solomon, Investor Relations. Please go ahead.

Thanks, Kevin. Good afternoon and welcome to the Fulgen Genetics fourth quarter and full year 2022 financial results conference call. On the call are Ming Hsieh, Chief Executive Officer of Fulgen, Paul Kim, Chief Financial Officer of Fulgen, and Brandon Perthews, Chief Commercial Officer of Fulgen. The company's press release discussing the financial results is available on the Investor Relations section of the company's website, www.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 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. 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 in what is described and 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 these 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, 2021, 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 they 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 and full year of 2022 for more information, including the description of how the company calculates non-GAAP income and earnings per share and a reconciliation in these financial measures to income and earnings per share, the most directly comparable GAAP financial measures. With that, I'd now like to turn the call over to Ming.

Thank you very much, Mellie. Good afternoon. And thank you for joining our call today. I will start with some comments on the quarter and the year. Then Brandon will review our product and go-to-market updates from the first quarter. And Paul will conclude with the financials and our 2023 outlooks before taking your questions. Looking at the fourth quarter, we exceeded our revenue guidance, reflecting 97% growth in our core business compared to 2021. We have integrated our recent acquisitions and are seeing those benefits in our annual results. For 2022, our core businesses will cross all diagnosis segments, precision diagnosis, anatomic pathology, and the pharma services. With the momentum in oncology, and reproductive services. With the informed diagnosis businesses, both of our capabilities in anatomic pathology and adding secretion and remedy, we will see pressure on our bottom line in the near term, which Paul will address. However, in long term, we believe this acquisition will make a good strategy stand for us. We continue to be the leader in precision diagnosis due to our NGS platform capabilities. An example of our successful COVID-19 testing program. Between 2020 and 2022, led by our $40 million CDC NGS wiring tracking contract, Fulgine delivered 19.3 million RT-PCR COVID-19 tests generated over $1.7 billion in revenue for Fujifilm. With the pandemic largely behind us, we're not anticipating additional COVID revenue in 2023. We are proud of what we've skilled our business so quickly and contributed so minimally to the testing efforts to fight the pandemic. We're seeing a similar opportunity to scale our platform to drive the growing demand by our customers for our beacon carrying screening test. Today we announced the expansion, Beacon 787, which Brandon will talk more about it. And we are anticipating associated annual growth of more than 300% in beacon sales as we grow this portion of our business. We believe this activity will further secure our leadership position in NGS, and it is an important factor in our annual guidance provided today. For 2023, a revenue guidance of $240 million, assuming 32% growth in our core business. driven by continued growth across all the areas of our diagnostic disease, including expansion and un-oncological carry screening through Beacon 787 announced today. Through our internal efforts and those of our lab partners, we are leveraging our proprietary NGS platform to broad application Fueled by our ongoing R&D effort, we have a long runway of opportunity in the core business and have seen Bangalore as a continued and dependable source of revenue and growth for Fulgine in the years ahead. In the first quarter, we announced the acquisition of Fulgine Farmer. We believe this acquisition has the potential to gradually transform forging from a genetic diagnosis services business into fully integrated precision medicine company focused on oncology. We joined by our team of talent individuals integrating our company to address the continual care that we believe begins with diagnosis and the patient care and the monitoring. Folgen Pharma has developed a novel nanoencapsulation and target therapy platform technology designed to improve therapeutic window and the pharmacokinetics profile for both new and existing cancer drugs. Our lead drug candidate, FID-07, has achieved a proof of concept for the treatment for numerous cancers, including head and neck ampullary, pancreatic, lung, and the breast. We continue to encourage the early data from these programs and are working on clinical paths forward, including additional clinical trials toward approval where fully we have full control of our manufacture process and can be very efficient. Given the current We have fully invented the GMP nanomaterials production plant, operating with experts and scientists who are now integrated into our organization. We have submitted updated clinical phase one B data to ESCO for presentation at the 2023 annual meeting in June. We look forward to share additional programs on the pharma business as we move throughout the year. We ended 2022 with a strong cash position, affording us the flexibility to pursue additional strategic opportunities as derived. Earlier this year, we were pleased to expand our board of directors with an addition of Reggie Growth. Reggie possessed a device business skill set and the global perspective that we believe were invaluable to our board. We entered a new chapter in precision medicine with our current acquisitions. Her expertise as a leader and an officer in various senior roles and with clinical and regulatory functions, particularly from her 13 years at the Mass Clinic, will add important insights into our business as we advance our mission to build a holistic platform that provides comprehensive solutions and services across cancer care continuum. From early detection, diagnosis, monitoring, drug discovery, and development, over the years, we have expanded and strengthened our report, adding additional expertise in diagnosis, therapeutic drug development, and commercialization. Now I'd like to thank our employees and shareholders for your support. That was a transitional and transformative year for 4G. I look forward to the years ahead and the momentum we are creating within our combined business. I turn over the call over Brandon, our Chief Commercial Officer, to talk about our diagnosis business results during the fourth quarter. Brandon?