This presentation contains forward-looking statements, which are statements other than those of historical facts and which represent the estimates and expectations of Fulgent Genetics, Inc. (the "Company" or "Fulgent") about future events based on current views and assumptions. Examples of forward-looking statements made in this presentation include, among others, those related to long-term upside or value, management of risk, anticipated growth and positioning, addressable market estimates, the Company's m ...

Financial Data and Key Metrics Changes - The company reported revenues of $87.1 million for Q1 2025, marking a 62% year-over-year growth in Exome and Genome revenues, which contributed $71.4 million this quarter [17][21] - Adjusted gross profit from continuing operations was $59.7 million, up 56% year-over-year, resulting in an adjusted gross margin of 69%, an increase from 61% a year ago [21][24] - Adjusted net income for Q1 2025 was $7.7 million, representing the third consecutive quarter of profitability [22][24] Business Line Data and Key Metrics Changes - Exome and Genome tests accounted for 40% of all tests in Q1, with volumes from these products up 24% year-over-year [17][21] - The company launched an ultra-rapid genome sequencing product in April, which delivers results in as soon as 48 hours, enhancing its service offerings [10][19] Market Data and Key Metrics Changes - The company expanded its market penetration among pediatric neurologists to 14% [10] - The average reimbursement rate for Exome and Genome tests increased to approximately $3,400, up from $2,600 in the same quarter last year [20] Company Strategy and Development Direction - The company is focused on integrating exome and genome testing as a standard of care, aiming to shift from reactive to proactive healthcare [8][12] - Plans to acquire Fabric Genomics, which will enhance AI-powered genomic interpretation and create a recurring software-based revenue stream [13][21] - The company is also targeting new clinical indications, including immune deficiency disorders and cerebral palsy, to drive growth [19][63] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strategic fit of the Fabric acquisition and its potential to unlock scalable platform economics [13][21] - The company anticipates a NICU volume ramp in the second half of the year, supported by foundational infrastructure laid in previous quarters [11][19] - Management reaffirmed guidance for 2025, expecting total revenues between $360 million and $375 million, with at least 30% growth in Exome and Genome volumes [24][25] Other Important Information - The company highlighted the importance of newborn screening and its potential contribution to revenue streams, likely in the 2027 timeframe [45][46] - The company is integrating AI across its business to enhance efficiency and accuracy in genomic interpretation [13][21] Q&A Session Summary Question: What are the reasons for the sequential decline in volumes in Q1? - Management acknowledged a historical pattern of volume decline from Q4 to Q1, exacerbated by weather disruptions and fewer sales days in Q1 [30][31] Question: What caused the increase in G&A expenses? - A significant portion of the increase was attributed to costs related to the Epic integration and general support costs, with expectations to drive down operating expenses as a percentage of revenue over time [33][34] Question: What visibility supports the expected acceleration in NICU volumes in the second half of the year? - Management indicated strong initial integration with Epic and a backlog of clients ready to come online, supporting the anticipated volume growth [37][38] Question: How is pricing expected to play out in Q2 and beyond? - Management noted that the average reimbursement rate is expected to remain stable, with ongoing efforts to reduce denials and improve the revenue cycle [39][42] Question: What is the expected impact of the weather disruptions on Q2 volumes? - Management expects to recoup some of the missed appointments in Q2, although the scarcity of specialists may delay recovery [88][90] Question: What are the expectations for new indications this year? - Management confirmed that new indications are expected to contribute to growth, with ongoing efforts to change standard care practices among physicians [63][66]

Financial Data and Key Metrics Changes - The company reported revenues of $87.1 million for Q1 2025, marking a 62% year-over-year growth in Exome and Genome revenues, which contributed $71.4 million this quarter [16][22] - Adjusted gross profit from continuing operations was $59.7 million, up 56% year-over-year, resulting in an adjusted gross margin of 69%, an increase from 61% a year ago [21][22] - Adjusted net income for Q1 2025 was $7.7 million, representing the third consecutive quarter of profitability [22] Business Line Data and Key Metrics Changes - Exome and Genome tests accounted for 40% of all tests in Q1, with volumes from these flagship products up 24% year-over-year [16] - The company launched its ultra-rapid genome sequencing product, which delivers results in as soon as 48 hours, enhancing its service offerings [10][19] Market Data and Key Metrics Changes - The company grew its market penetration of pediatric neurologists to 14% [9] - Average reimbursement rate for Exome and Genome tests increased to approximately $3,400, up from $2,600 in the same quarter last year [20] Company Strategy and Development Direction - The company is focused on integrating exome and genome testing as a standard of care, aiming to shift from reactive to proactive healthcare [7][8] - Plans to acquire Fabric Genomics, which will enhance AI-powered genomic interpretation and create a recurring software-based revenue stream [12][13] - The company is expanding into new clinical indications and markets, including NICU and adult testing, to capture growth opportunities [10][19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strategic fit of the Fabric acquisition and its potential to unlock scalable platform economics [13] - The company anticipates continued growth in its core exome and genome testing business, with a guidance increase for total revenues to between $360 million and $375 million for the full year 2025 [23][25] Other Important Information - The company highlighted the importance of newborn screening and its potential revenue contribution, expected to materialize around 2027 [46] - Management noted that only 5% of rare diseases currently have approved therapies, emphasizing the critical role of genomic data in drug discovery [14] Q&A Session Summary Question: What are the reasons for the sequential decline in volumes in Q1? - Management acknowledged a historical pattern of volume decline from Q4 to Q1, exacerbated by weather disruptions and fewer sales days in Q1 [30][31] Question: What contributed to the increase in G&A expenses? - A significant portion of the increase was attributed to costs related to the Epic integration and general support costs, with expectations of driving down OpEx as a percentage of revenue over time [34][35] Question: What visibility supports the expected acceleration in NICU volumes in the second half of the year? - Management indicated that initial integration with Epic is on track and that there is a solid pipeline of clients ready to come online [38] Question: How is pricing expected to play out in Q2 and beyond? - Management noted that the average reimbursement rate is expected to remain stable, with ongoing efforts to reduce denials and improve the revenue cycle [40][43] Question: What is the expected impact of the weather disruptions on Q2 volumes? - Management expects to recoup some of the missed appointments in Q2, although long wait times for specialist appointments may affect recovery [90] Question: What are the expectations for new indications this year? - Management confirmed that new indications, including immune deficiencies and cerebral palsy, are expected to contribute to growth, although it is too early to quantify their impact [63][65]

Financial Performance - GeneDx grew revenues to $87.1 million, a 42% increase year-over-year[4] - Exome and genome test revenue grew to $71.4 million, a 62% increase year-over-year, representing 40% of all test results[4,9] - The company delivered an adjusted gross margin of 69%, up from 61% in the first quarter of 2024[4] - Adjusted net income for the first quarter of 2025 was $7.7 million[4,13] - Cash, cash equivalents, marketable securities, and restricted cash totaled $160.2 million as of March 31, 2025[13] Guidance and Acquisition - Full year 2025 revenue is projected to be between $360 million and $375 million, including $3 million to $5 million from the Fabric Genomics acquisition[5] - Exome/genome volume and revenue growth is expected to be at least 30%[5] - Adjusted gross margins are projected to be between 66% and 68%[5] - GeneDx announced plans to acquire Fabric Genomics, with the deal expected to close in Q2 2025, for an upfront purchase price of $33 million, potentially reaching $51 million in total consideration[4,30] Market and Strategy - GeneDx has contracted with 80% of covered lives, including all large national commercial payers[58,65,82] - The company estimates a $45 billion total market opportunity for exome/genome use cases, with $25 billion in pediatrics and rare diseases and $20 billion in adult applications[56] - GeneDx has screened 17,000 healthy infants with genome sequencing in the GUARDIAN study, with a goal of >100,000[80]

Core Insights - The genetic screening testing market for preventive health is experiencing rapid growth due to technological advancements, increased consumer interest in personalized medicine, and a rise in preventive healthcare strategies [2][3][5]. Market Overview - The market is driven by improvements in genetic testing technologies, such as next-generation sequencing (NGS), which have made tests more accessible, cost-effective, and accurate [3][5]. - Growing consumer awareness of early detection benefits, rising healthcare costs, and a focus on prevention are fueling demand [3][6]. Market Dynamics - The increasing availability of direct-to-consumer genetic tests empowers individuals to manage their health and gain insights into genetic predispositions [4][5]. - Stakeholders include genetic testing companies, healthcare providers, hospitals, diagnostic laboratories, and wellness organizations [4]. Regional Analysis - North America holds the largest market share, driven by technological advancements and high consumer awareness, with the U.S. being a key player [8]. - Europe is characterized by high demand for genetic tests related to cancer and cardiovascular diseases, with significant investments in preventive healthcare [9]. - The Asia-Pacific region is experiencing significant growth due to rising healthcare awareness and investment in healthcare infrastructure, with China and India emerging as key markets [10]. - The Middle East and Africa show emerging opportunities for genetic screening, particularly in the UAE, Saudi Arabia, and South Africa [11]. Competitive Landscape - Key players in the market include Exact Science, Labcorp Genetics Inc., Blueprint Genetics, Ambry Genetics, and others [7]. - The competitive landscape is marked by strategies such as funding activities, mergers and acquisitions, regulatory approvals, and partnerships [18].

Core Points - The US Federal Trade Commission (FTC) has warned 23andMe to protect users' personal information amid its bankruptcy proceedings [1][3] - 23andMe, which offers genetic testing services, filed for bankruptcy and is seeking a buyer after experiencing a significant data breach [2][5] - The FTC emphasized that any sale or transfer of personal information during bankruptcy must adhere to the company's privacy commitments [3][4] Company Overview - 23andMe, a Silicon Valley-based company, went public in 2021 and claims to have 15 million customers [5] - The company has faced declining sales as interest in genetic testing waned and suffered a data breach affecting 6.9 million accounts [5][7] - In response to financial difficulties, 23andMe laid off 40% of its workforce, approximately 200 employees, and suspended research programs [5] Data Breach Details - The data breach compromised sensitive information, including names, sex, birth year, location, photos, health information, and genetic ancestry results [7] - 23andMe has agreed to pay around $37.5 million to settle claims related to the 2023 data breach [5]

Core Viewpoint - 23andMe has filed for Chapter 11 bankruptcy but intends to continue operations while restructuring its finances and has secured $35 million in financing for this process [3][4]. Company Overview - Founded in 2006, 23andMe has sold over 12 million DNA testing kits and has notable users such as Oprah Winfrey and Warren Buffett [3]. - The company has faced financial difficulties since 2021, including a significant workforce reduction of 40% in 2024 and the resignation of all independent directors [6]. Data Privacy Concerns - The bankruptcy filing has raised concerns about the handling of customer data, particularly genetic information, during the restructuring process [4][7]. - 23andMe's privacy policies indicate that personal information may be accessed, sold, or transferred during bankruptcy proceedings [8]. - A data breach in 2023 exposed personal information of 6.9 million users, although no genetic data was compromised [5]. Legal and Regulatory Context - Genetic information is treated similarly to personal information under privacy laws, with varying protections depending on the jurisdiction [10][11][12]. - In the U.S., there is a lack of a unified legal framework for consumer privacy, complicating the situation for 23andMe customers [12][13]. Future Outlook - 23andMe may successfully emerge from its restructuring, similar to other companies that have filed for Chapter 11 bankruptcy [9]. - The company could potentially expand licensing agreements with pharmaceutical firms to utilize customer data for research purposes [9]. Consumer Guidance - Customers are advised to consider deleting their accounts and withdrawing consent for the use of their data due to uncertainties surrounding the company's future [15][16]. - Legal experts emphasize the need for clearer regulations to protect consumer privacy, especially concerning genetic data [17].

Core Viewpoint - The announcement of 23andMe filing for bankruptcy and selling its genetic genealogy database has raised privacy concerns among its customers, prompting legal alerts regarding data deletion [1][2]. Company Overview - 23andMe, founded in 2006 by Anne Wojcicki, was the first to market direct-to-consumer genetic testing in North America, aiming to provide consumers with health information directly [6]. - The company initially thrived by capitalizing on the growing interest in genealogy and health data, but faced significant challenges, including a major data breach in 2023 that compromised the personal information of approximately 5.5 million users [12][13]. Industry Context - The consumer genetic testing industry has seen a decline in sales due to privacy concerns and market saturation, with a notable drop in demand for genetic genealogy kits over the past five years [9]. - Law enforcement's use of genetic genealogy databases has heightened consumer awareness of potential third-party data usage, leading to increased scrutiny and calls for regulatory measures [10][11]. Financial and Corporate Developments - 23andMe has expanded its operations by acquiring health services and pharmaceutical companies, but its financial stability has been jeopardized by recent events, including the bankruptcy filing [12]. - Potential buyers for 23andMe's database include large pharmaceutical companies, international buyers, and tech firms like Google and Ancestry.com, which could significantly reshape the landscape of genetic data ownership [15][16]. Privacy and Regulatory Issues - The sale of genetic databases raises concerns about changing privacy provisions, with customers uncertain about the long-term protection of their data [18]. - The rapid growth of the direct-to-consumer genetics industry has outpaced regulatory frameworks, leaving consumers vulnerable and anxious about their personal data [19].

Core Insights - DeleteMe is providing essential support to individuals concerned about their personal data on 23andMe's platform amid the company's bankruptcy filing [1][2] - The lack of transparency regarding 23andMe's DNA data-privacy controls has escalated into a significant issue, prompting users to seek data removal services [2][3] - DeleteMe's service allows users to proactively delete their sensitive genetic data, ensuring data privacy in light of 23andMe's financial instability [3][4] Company Overview - DeleteMe is a leading data privacy service focused on helping individuals manage and protect their personal information online [5] - The company specializes in the removal of personal data from online platforms, aiming to help users regain control over their digital footprint [5] Service Process - The data removal process includes three main steps: Data Assessment, Data Removal, and Ongoing Monitoring [7] - DeleteMe evaluates the personal data stored with 23andMe, works to remove all sensitive information, and provides continued privacy monitoring to ensure data remains deleted [7]

Core Points - 23andMe is seeking a new owner as part of its Chapter 11 bankruptcy protection proceedings to maximize business value and address operational and financial challenges [1][4] - The company emphasizes the importance of customer data protection in any potential sale, stating that it remains committed to user privacy [2][10] - Following court approval, 23andMe will work with an independent investment banker to solicit offers from interested buyers over a 45-day period, with an auction planned if multiple offers are received [4][7] Financial and Legal Context - The company filed for Chapter 11 in the U.S. Bankruptcy Court for the Eastern District of Missouri, indicating significant operational and financial difficulties [1] - Litigation related to a 2023 data breach, which exposed the genetic data of nearly 7 million customers, has increased liabilities and contributed to the bankruptcy filing [5][6] - 23andMe agreed to pay $30 million and provide three years of security monitoring to settle a lawsuit regarding the data breach [6] Management and Strategic Moves - CEO Anne Wojcicki has resigned to position herself as an independent bidder for the company [7][8] - The company has reached out to numerous potential buyers, indicating a proactive approach to finding a new owner [7]