Financial Data and Key Metrics Changes - The company has been focused on driving utilization, ensuring strong reimbursement coverage, and reducing turnaround times and costs to open up access [4] - The gross margin for chromosomal microarray tests has improved to 40% - 50% from a negative margin a few years ago [15] Business Line Data and Key Metrics Changes - The company has diagnosed more children with rare diseases than anyone else globally, with a data asset of over 3 million patients and more than 850,000 exomes and genomes [3][4] - The company is expanding its focus from expert geneticists to pediatric specialists, aiming to reduce the average age of diagnosis from five years to three years [12] Market Data and Key Metrics Changes - There are approximately 600,000 children diagnosed with developmental or intellectual delays, with 60,000 general pediatricians involved in diagnosing these conditions [13][14] - The company is targeting 12 Epic integrated systems by the end of the year, with a goal to connect to over 800 level three and four NICUs [22][25] Company Strategy and Development Direction - The company aims to become a household name in genetic testing, focusing on early diagnosis of rare diseases to alleviate the burden on families [2][17] - The acquisition of Fabric Genomics is intended to enhance the company's interpretation-as-a-service capabilities and expand into international markets without the need for extensive lab setups [36][38] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the new guidelines from the American Academy of Pediatrics, which could significantly shift the standard of care for children and increase testing utilization [12][17] - The company anticipates an 18 to 24-month timeline for significant changes in general pediatrician behavior regarding testing orders [19] Other Important Information - The company has made over 500 gene disease discoveries, contributing to a virtuous cycle of product improvement [9] - The company is focusing on expanding its biopharma business, which has shown potential for significant growth by matching patients to clinical trials [40][41] Q&A Session Summary Question: What is the anticipated mix between two-day and five-day tests? - The company charges more for ultra-rapid testing ($5,000 to $7,000) compared to the five-day turnaround tests, which are priced lower [29] Question: What is the size of the volume base that could be converted quickly? - The company is focusing on general pediatricians who are actively diagnosing children with developmental delays, aiming to convert existing orders through education and improved customer experience [13][15] Question: What does the Fabric Genomics acquisition add to the business? - The acquisition allows the company to leverage its data asset for interpretation-as-a-service globally, enhancing diagnostic accuracy and efficiency [36][38] Question: How is the company approaching the NICU opportunity? - The company is targeting NICUs to increase genetic testing utilization, with a current testing rate of less than 5% among NICU patients [24][25] Question: What are the company's expectations for the pediatric market? - The company expects early adopters among general pediatricians to begin ordering tests within the next 18 to 24 months, although significant impacts on revenue are not anticipated until later [21][19]

GeneDx FY Conference Summary Company Overview - **Company**: GeneDx - **Industry**: Genomics Testing - **Focus**: Whole exome and whole genome sequencing, particularly for rare and pediatric diseases [1][2] Core Mission and Vision - **Mission**: To diagnose genetic diseases as early as possible to provide therapeutic options and improve patient outcomes [3] - **Current Focus**: Pediatric segment, with a strong emphasis on rare diseases [4] - **Future Goals**: Expand into proactive and predictive medicine [5] Financial Performance - **Q2 Revenue**: Over $100 million, indicating strong demand for services [6] - **Growth Drivers**: - 75% of growth from existing customers, indicating high service value [7] - 25% from new customers [7] - **Market Share**: 80% in clinical and medical geneticists [8] Market Adoption and Opportunities - **General Pediatricians**: Targeting this group as a key opportunity for future growth, especially following updated AAP guidelines [11] - **Current Penetration**: 14% among pediatric neurologists, indicating significant room for growth [12] Competitive Landscape - **Market Position**: Maintains leading position due to a robust data asset and high accuracy [13] - **Data Asset**: Over 850,000 exomes and genomes run, enriched for rare diseases [15] - **Diversity**: Data asset is representative of the US population, unlike many competitors [16] Technological Integration - **AI Utilization**: Implementing AI for workflow optimization and enhancing diagnostic accuracy [19] - **Epic Integration**: Aiming to embed services within health systems to broaden reach [21] Reimbursement Landscape - **Coverage**: 80% of American lives covered, with 35 states covering exome testing in outpatient settings [22][23] - **Denial Rates**: Over half of tests currently paid, with efforts to reduce denials through improved revenue cycle management [26][27] - **Economic Argument**: Highlighting the cost savings of early diagnosis to healthcare systems [24][25] NICU Market Expansion - **SEEK First Study**: Demonstrated that 60% of NICU patients could benefit from rapid sequencing [31] - **Market Size**: Estimated at 250,000 tests per year in NICUs [35] Long-term Growth Drivers - **International Expansion**: Utilizing the Fabric business for global growth [45] - **Adult Population**: Plans to address genetic conditions affecting adults, such as Parkinson's and Alzheimer's [46] - **Data Asset Utilization**: Leveraging the data asset for ongoing competitive advantage [46] Key Challenges - **Education and Adoption**: Need for ongoing education to drive adoption among pediatricians [39][40] - **Customer Experience**: Simplifying the testing process and reporting for non-genetics experts [41] Conclusion GeneDx is positioned strongly within the genomics testing industry, with a clear focus on pediatric rare diseases and a robust data asset that supports its competitive edge. The company is actively working to expand its market share, improve reimbursement rates, and enhance its technological capabilities while addressing the challenges of education and customer experience.

NEW YORK, Aug. 06, 2025 (GLOBE NEWSWIRE) -- Scott+Scott Attorneys at Law LLP (“Scott+Scott”), a shareholder litigation firm, alerts investors that it is investigating whether GeneDx Holdings Corp. (“GeneDx” or the “Company”) (NASDAQ: WGS) or certain of its officers and directors issued misleading and false statements and/or failed to disclose information material to investors in violation of federal securities laws. CLICK HERE TO RECEIVE ADDITIONAL INFORMATION ABOUT THIS POTENTIAL CLASS ACTION GeneDx perfor ...

Investor Presentation 255 126 22 August 1, 2025 Founded in 2011 | Located in El Monte, CA | NASDAQ:FLGT Disclaimer Forward-Looking Statements and Market Data 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, a ...

Core Insights - GeneDx Holdings experienced a significant stock increase of over 8% following a strong second-quarter earnings report, contrasting with a 0.3% decline in the S&P 500 index [1] Financial Performance - The company reported nearly $103 million in revenue for the second quarter, marking a 49% year-over-year growth, driven by a 69% increase in exome and genome testing services, totaling 23,102 tests [2] - GeneDx achieved a non-GAAP net income of just under $15 million, a turnaround from a loss of over $2 million in the same quarter of the previous year, equating to earnings of $0.50 per share [4] - Both revenue and adjusted net income figures exceeded analyst expectations, with consensus estimates at approximately $85 million in revenue and an adjusted net income of $0.12 per share [5] Future Guidance - The company raised its revenue guidance for 2025 to a range of $400 million to $415 million, up from a previous estimate of $360 million to $375 million, largely due to anticipated growth in exome and genome revenue, now projected to increase by 48% to 52% over 2024 figures, compared to an earlier estimate of 30% [6] - GeneDx maintained its guidance for adjusted net income growth, indicating it will remain a positive figure for each quarter and for the year overall, though specifics were not provided [7]

Financial Data and Key Metrics Changes - The company reported revenues of $102.7 million for Q2 2025, a 49% increase year-over-year [20] - Exome and Genome revenue reached a record high of $85.9 million, up 69% from the same quarter last year [20] - The average reimbursement rate for Exome and Genome tests was over $3,700, an increase from approximately $3,400 in the previous quarter [20] - Adjusted gross margin expanded to a record high of 71%, driven by favorable mix shift, improved reimbursement, and lower COGS [24] - Adjusted net income for Q2 was $15 million, marking the fourth consecutive quarter of profitability [26] Business Line Data and Key Metrics Changes - The majority of Q2 volume growth came from existing clinicians, with 23,102 Exome and Genome tests reported, a 28% increase compared to the same quarter last year [22] - New indications like cerebral palsy and pediatric immunologists contributed to early signs of increased adoption [12][43] - The NICU market represents a significant opportunity, with fewer than 5% of babies currently receiving genetic tests [13] Market Data and Key Metrics Changes - The company has captured nearly a third of its target clinicians in the pediatric neurology segment [11] - Pediatric neurologists accounted for most of the volume growth in Q2, with 25% coming from new clinicians [43] - The general pediatrician market remains largely untapped, with 60,000 pediatricians in the U.S., of which about 25,000 diagnose children with developmental or intellectual delays [15] Company Strategy and Development Direction - The company aims to shift healthcare from reactive to proactive, focusing on early genetic diagnosis to improve health outcomes [6][8] - Plans to engage pediatricians through educational initiatives and presence at the AAP meeting to promote the use of exome and genome sequencing [16][38] - The integration of Fabric Genomics is expected to enhance the company's capabilities and competitive edge in genomic testing [10][76] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving at least 30% year-over-year volume growth for the full year 2025 [22][27] - The company anticipates that the NICU and general pediatric markets will drive growth in the second half of the year [12][44] - Management highlighted the importance of reducing denial rates and improving collection processes as key drivers of financial performance [21][72] Other Important Information - The company raised its full-year revenue guidance to between $400 million and $415 million for 2025 [27] - The acquisition of Fabric Genomics included a payment of $33.2 million at closing [26] Q&A Session Summary Question: ASPs trounced estimates, what were the drivers? - Management noted improvements in revenue cycle processes and increased Medicaid coverage across states as key drivers for higher ASPs [33][34] Question: How to balance investment in the pediatric market? - The company will focus on pediatric neurology while gradually building the general pediatrician market, emphasizing education and marketing efforts [37][38] Question: What is the impact of NICU and new indications on volume growth? - Management expects significant contributions from NICU testing and new indications in Q3 and Q4, with a focus on activating new accounts [44][46] Question: What is the current denial rate? - The paid rate has improved to the mid-50s, with ongoing efforts to reduce denials further [72] Question: How is the integration of Fabric Genomics progressing? - The integration is on track, with positive collaboration between teams and plans to expand into international markets [76][78]

Financial Data and Key Metrics Changes - The company reported revenues of $102.7 million for Q2 2025, a 49% increase year over year [19] - Exome and Genome revenue reached a record high of $85.9 million, up 69% from the same quarter last year [19] - The average reimbursement rate for Exome and Genome tests was over $3,700, an increase from approximately $3,400 in the previous quarter [19] - Adjusted gross margin expanded to a record high of 71%, driven by favorable mix shift, improved reimbursement, and lower COGS [22] - Adjusted net income for Q2 was $15 million, marking the fourth consecutive quarter of profitability [25] - Cash, cash equivalents, and marketable securities totaled $135.5 million as of June 30, 2025 [25] Business Line Data and Key Metrics Changes - The company conducted 23,102 Exome and Genome tests in Q2 2025, a 28% increase compared to the same quarter last year [21] - Most volume growth came from existing doctors, with 25% of volume growth attributed to new clinicians [44] - The introduction of new indications like cerebral palsy is expected to drive increased same-store sales [21][44] Market Data and Key Metrics Changes - Pediatric neurologists constituted a majority of new exome and genome ordering providers, capturing nearly a third of the target clinicians in this segment [10] - The NICU market represents a billion-dollar opportunity, with fewer than 5% of babies currently receiving genetic tests [12] - The company has established a presence in 42 out of the 50 top NICUs, with expectations for significant scaling in NICU testing [12] Company Strategy and Development Direction - The company aims to shift healthcare from reactive to proactive, focusing on early genetic diagnosis to improve health outcomes [6][7] - Plans to engage pediatricians and expand into the general pediatrics market, targeting 60,000 pediatricians in the U.S. [14][15] - The acquisition of Fabric Genomics is expected to enhance the company's capabilities and competitive edge in genomic testing [9][78] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving at least 30% year-over-year volume growth for the full year 2025 [21][26] - The company anticipates that the broader adoption of genomic testing will take 18 to 24 months following new guidelines from the American Academy of Pediatrics [16][96] - Management highlighted the importance of simplifying the ordering process for pediatricians to facilitate adoption [92] Other Important Information - The company is focused on building partnerships with pharmaceutical companies to leverage genomic data for drug development [17] - The integration of AI into the proprietary interpretation platform is expected to enhance accuracy and scalability [9] Q&A Session Summary Question: ASPs trounced estimates; what drove this? - Management attributed the increase to major overhauls in the revenue cycle and improved adherence to documentation requirements [32][34] Question: How to balance investment in pediatric market with current business? - The company will continue to focus on pediatric neurology while gradually building the general pediatric market [37][38] Question: How is the NICU market progressing? - The company has three health systems live with Epic and expects to onboard at least 12 more in the second half of the year [46] Question: What is the current denial rate? - The paid rate is now in the mid-50s, reflecting improvements in the revenue cycle [72] Question: How is the Fabric Genomics integration progressing? - The integration is on track, with a focus on leveraging AI and expanding into international markets [78] Question: What is the timeline for commercial payers to adopt new guidelines? - The company expects an 18 to 24-month timeline for operationalizing new guidelines with payers [96]

GeneDx (Nasdaq: WGS) 2Q 2025 Earnings Presentation July 29, 2025 On average: 16 tests and 5 years before an accurate diagnosis Forward Looking Statements This presentation contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding our future performance, future operations, plans, objectives of management, and our market opportunity, including our expected full year 2025 reported revenue, volume, adjusted gross margin and adjusted net income. ...

Company Overview - GeneDx Holdings is a healthcare technology company that integrates AI and machine learning with clinical and genomic data, focusing on precision medicine and individualized patient care [7] - The company has a market capitalization of $2.29 billion and reported a revenue of $330 million with a net income of -$38.6 million for the trailing twelve months [6] Recent Financial Performance - GeneDx Holdings shares have appreciated by 141.5% over the past year as of July 11, 2025 [5] - The company reported a 42% year-over-year increase in revenue for the first quarter, driven by high volumes of exome and genome tests [9] - Revenue from exome and genome tests accounted for 82% of GeneDx's total Q1 revenue, with the net loss for the quarter shrinking to $6.5 million from $20 million in the prior-year period [10] Insider Activity - On July 11, 2025, Kevin Feeley, CFO of GeneDx Holdings, sold 5,278 shares, reducing his holdings to 3,392 shares, which represents approximately 0.01% of total shares outstanding [1][4] - This sale is consistent with Feeley's recent trading patterns, as it is near the median trade size for him over the last several quarters [3] Growth Catalysts - GeneDx has strong growth prospects, particularly following its acquisition of Fabric Genomics, which enhances its AI-driven test interpretations and expands its genomics testing portfolio [12] - The company is targeting a larger patient population by expanding testing to outpatient pediatrics, NICU patients, and newborns [11] - Management has raised its full-year revenue guidance to a range of $360 million to $375 million, up from the previous forecast of $350 million to $360 million [10]

Core Points - TTAM Research Institute has acquired the Personal Genome Service and Research Services business lines of 23andMe Holding Co. under Section 363 of the U.S. Bankruptcy Code [1] - 23andMe will continue to operate under TTAM, providing personalized DNA testing and research services while ensuring customer choice and data transparency [2] Company Information - 23andMe is a genetics-led consumer healthcare company focused on empowering a healthier future [6] - TTAM Research Institute is a nonprofit medical research organization dedicated to advancing understanding of DNA and enabling individuals to contribute their genetic information to scientific research [7]