GeneDx (WGS) Q1 2025 Earnings Call April 30, 2025 08:30 AM ET Company Participants Sabrina Dunbar - Director of IR & CommunicationsKatherine Stueland - President & CEOKevin Feeley - Chief Financial OfficerTycho Peterson - Managing DirectorBrandon Couillard - Managing Director Conference Call Participants Bill Bonello - Senior Research AnalystDan Brennan - AnalystMark Massaro - Managing Director - Senior Equity Research AnalystMatthew Sykes - Analyst Operator Good day and thank you for standing by. Welcome t ...

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]

GeneDx (Nasdaq: WGS) 1Q 2025 Earnings Presentation April 30, 2025 Forward Looking Statements This presentation contains certain forward-looking statements within the meaning of the federal securities laws, including statements regarding our future performance and our market opportunity, including our expected full year 2025 reported revenue and volume guidance, adjusted gross margin and our adjusted net income in 2025. These forward-looking statements generally are identified by the words "believe," "projec ...

The FTC has powers to protect consumers from unfair, deceptive, or fraudulent business practices and investigate suspected violations. The bankruptcy announcement on March 23 prompted warnings for 23andMe customers to ask the company to delete their data to safeguard privacy. This article has been reviewed according to Science X's editorial process and policies . Editors have highlighted the following attributes while ensuring the content's credibility: The US Federal Trade Commission (FTC) on Monday warned ...

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].

Financial Data and Key Metrics Changes - Full-year core revenue totaled $281.2 million, a growth of 7% compared to $262.1 million in 2023, slightly exceeding guidance of $280 million [31] - Fourth-quarter revenue was $76.2 million, compared to $70.5 million in Q4 2023, with core business revenue at $76 million [32] - GAAP gross margin was 41.8%, while non-GAAP gross margin was 44.2%, showing improvement over the year [32] - GAAP loss for 2024 was $42.7 million, or a loss of $1.41 per share, while non-GAAP income was $15 million, or $0.49 per share [31] Business Line Data and Key Metrics Changes - Anatomic pathology grew sequentially by 9% due to a revised go-to-market plan, focusing on dermatopathology [17][56] - Precision diagnostics delivered fourth-quarter growth of 23% year over year, with significant contributions from the Beacon expanded carrier screening product [19] - Biopharma services experienced a 56% growth quarter over quarter, increasing from $3.9 million in Q3 to $6.1 million in Q4 [27] Market Data and Key Metrics Changes - The company expects total core revenue to be approximately $310 million for 2025, representing a 10% year-over-year growth [36] - Expected revenues for 2025 are estimated as follows: $187 million from Precision Diagnostics, $106 million from anatomic pathology, and $17 million from biopharma services [39] Company Strategy and Development Direction - The company is focused on expanding its laboratory capabilities and sales team to drive growth in its core business [28][39] - Significant advancements in therapeutic development include a clinical pipeline with two candidates, FID-007 and FID-022, targeting cancer treatments [9][11] - The company is evaluating opportunities for mergers and acquisitions, leveraging its strong cash position [29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth in laboratory services and therapeutic development, with a strong financial position to execute its strategy [15][41] - The anticipated cash burn for the therapeutic development business is approximately $25 million for 2025, which is considered efficient [40][100] - Management highlighted the importance of maintaining operational efficiency and quality in service delivery to capture market share [18][95] Other Important Information - The company has made significant investments in technology to improve operational efficiency and turnaround times in its anatomic pathology business [95] - A new partnership with Foundation Medicine is expected to enhance the company's offerings in germline oncology testing [24][70] Q&A Session Summary Question: Key milestones for FID-007 and clinical trial costs - The clinical trial for FID-007 is expected to cost around $10 million, with promising preliminary results [45][46] Question: Dynamics affecting Q4 growth - No one-time events were identified; growth was attributed to market share gains [47][50] Question: Revised plan for anatomic pathology growth - The revised plan focused on targeting the dermatopathology market, leading to a 9% sequential growth [55][56] Question: Updates on VA hospital contract and revenue expectations - Revenue from the VA contract is still being assessed, but initial progress is very positive [72] Question: Cash utilization for clinical trials - The expected cash burn for therapeutic development in 2025 is around $25 million, considered efficient for advancing critical drug candidates [99][100]