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.

Core Viewpoint - Scott+Scott Attorneys at Law LLP is investigating GeneDx Holdings Corp. for potentially issuing misleading statements and failing to disclose material information, which may violate federal securities laws [1] Company Performance - GeneDx specializes in genetic testing for rare diseases, particularly whole exome and genome tests, and has seen a significant increase in test volume and revenue over the past two years, with quarterly E&G test volume more than doubling and revenue tripling [2] - In the first quarter of 2025, GeneDx reported flat E&G test volume and revenue for the first time in eight quarters, leading to a substantial decline in stock price [4] Allegations and Market Reaction - A report by Grizzly Research alleged that GeneDx engaged in "code stacking," inflating revenue by 25% through improper billing practices, which resulted in a nearly 7% drop in stock price on the day the report was released [3] - Following the release of the flat financial results, GeneDx's stock price fell by nearly 43% [4]

Financial Performance - Fulgent Genetics' Q2 2025 core revenue reached $82 million, a 16% year-over-year increase [12, 13] - The company's last twelve months (LTM) core revenue as of Q2 2025 was $3029 million, a 14% year-over-year increase [81] - Q2 2025 gross profit was $34435 thousand, with a gross margin of 421% [85, 88] - Non-GAAP gross profit for Q2 2025 was $36036 thousand, resulting in a non-GAAP gross margin of 441% [87, 90] - The company anticipates approximately $770 million in cash, cash equivalents, and investments in marketable securities as of December 31, 2025 [92] Financial Guidance - Fulgent Genetics projects a full-year 2025 core revenue of $320 million, representing a 14% year-over-year growth [92] - The company expects a GAAP EPS of ($210) and a non-GAAP EPS of ($035) for the full year 2025 [92] - The revenue breakdown for 2025 is projected as follows: Precision Diagnostics at $194 million, Anatomic Pathology at $108 million, and BioPharma Services at $18 million [92] Therapeutic Development - FID-007, a wholly-owned drug candidate, is initially focused on Head & Neck (H&N) and Pancreatic/Ampullary cancers [76] - Preliminary findings from the FID-007 Phase 1/1b clinical trial showed a 45% ORR and 72% DCR in heavily treated HNSCC patients [61] - The Phase 2 trial for FID-007 plus Cetuximab in H&N cancer has multiple clinical sites activated with 32 patients dosed as of August 1, 2025 [62] - The market opportunity for Head & Neck cancer is estimated at $186 billion in 2025, growing to $21 billion by 2035 [19, 72]

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]

Core Viewpoint - 23andMe Holding Co. has received approval from the U.S. Bankruptcy Court for the sale of its assets and ongoing business operations to TTAM Research Institute for $305 million, marking a significant step in the company's transition to a nonprofit model [1][2]. Group 1: Transaction Details - The sale includes substantially all of 23andMe's assets, such as the Personal Genome Service (PGS) and Research Services business lines, as well as the Lemonaid Health business [2]. - The transaction is expected to close in the coming weeks, pending customary closing conditions [1]. Group 2: Company Mission and Future - The acquisition by TTAM is aimed at continuing 23andMe's mission of helping individuals access and understand their genetic information for health benefits [2][3]. - TTAM, as a nonprofit, will focus on improving public knowledge of DNA and enhancing healthcare access globally [3]. Group 3: Customer Data and Privacy - TTAM is committed to providing customers with choice and transparency regarding their genetic data, including options to change their participation in research [3]. - The organization will adhere to 23andMe's existing privacy policies and implement additional consumer protections for customer data [3].