GeneDx (WGS) - 2025 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company reported third quarter 2025 revenues of $116.7 million, a 52% increase year-over-year [14] - Adjusted gross margin expanded to 74%, driven by favorable mix shift, improved reimbursement, and lower COGS [17] - Adjusted net income for the quarter was $14.7 million, with adjusted basic EPS of $0.51 [21] Business Line Data and Key Metrics Changes - Revenue from exome and genome testing was $98.9 million, up 66% from the same quarter last year [14] - The company conducted 25,702 exome and genome tests in the third quarter, with growth accelerating from 24% year-over-year in Q1 to 33% in Q3 [14] - The hereditary cancer offerings were discontinued, generating $1.2 million in Q3 2025, down from $3.3 million in the same quarter last year [22] Market Data and Key Metrics Changes - The average reimbursement rate for exome and genome testing was over $3,800 in Q3, up from approximately $3,700 in the previous quarter [16] - The NICU market remains underpenetrated, with less than 5% of NICU patients receiving genetic testing [10] - The company is on track to activate at least 12 Epic Aura integrations by the end of the year [10] Company Strategy and Development Direction - The company aims to drive high profitable growth, offer best-in-class diagnostics, and build a network for precision medicine [6] - GeneDx Infinity, the largest rare disease dataset, is leveraged to generate genomic insights and enable fast diagnoses [7] - The company plans to nearly double its sales force over the coming quarters to enhance market penetration [9] Management's Comments on Operating Environment and Future Outlook - Management raised 2025 revenue guidance to $425 million-$428 million, reflecting strong momentum [5] - The company is focused on transforming healthcare from reactive to proactive, particularly in newborn screening [11] - Management expressed confidence in maintaining profitability while investing in long-term growth [19] Other Important Information - The FDA granted breakthrough device designation to ExomeDx and GenomeDx tests, validating the company's technology [7] - The company is expanding its international market presence and has begun hiring for key positions [12][8] - The company generated $9 million in free cash flow during the third quarter [21] Q&A Session Summary Question: Has there been an uptick in volume due to the AAP guidelines? - Management noted that most pediatricians are hearing about the guidelines from GeneDx and emphasized the need for education [31] Question: What is the outlook for average selling prices and margins? - Management indicated that ASPs may decrease slightly due to new market entries but remains optimistic about long-term margins [34][37] Question: What is the status of the NICU market? - Management confirmed that NICU volumes are growing and that they are on track to activate more systems [40][44] Question: Can you elaborate on OpEx spending and its impact? - Management stated that OpEx is expected to increase as they build out the sales team and invest in growth initiatives [47][49] Question: What is the plan for the sales force expansion? - Management plans to double the sales force and is currently hiring Regional Sales Directors to lead the effort [52][53] Question: What is the expected impact of the FDA breakthrough designation? - Management believes the designation will enhance market access and validate their technology among clinicians [63][68]