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]

Financial Data and Key Metrics Changes - The company reported $47 million in revenue for Q1 2025, exceeding expectations and showing a growth of over $4 million from Q4 2024 [6][27] - GAAP net loss before noncontrolling interests was $53 million for Q1 2025, compared to a loss of $23 million in Q1 2024 [27] - Adjusted EBITDA was negative $11 million for Q1 2025, down from a positive $8 million in Q1 2024 [28] - Basic and diluted EPS for Q1 was a loss of $0.21 per share, compared to a loss of $0.09 per share in Q1 2024 [30] Business Line Data and Key Metrics Changes - The Nucleic Acid Production (NAP) segment generated $29 million in revenue for Q1 2025, an increase of $1 million from Q4 2024 [6] - The Biologics Safety Testing (BST) segment reported $18 million in revenue for Q1 2025, up $3 million from Q4 2024 and flat compared to Q1 2024 [6][35] - The adjusted EBITDA margin for the BST segment was 70%, indicating strong performance [35] Market Data and Key Metrics Changes - Revenue by customer type in Q1 was 29% from biopharma, 28% from life science and diagnostics, 6% from academia, 7% from CDMO, and 30% through distributors [7] - Revenue by geography was 62% from North America, 15% from EMEA, 15% from Asia Pacific, and 8% from China [7] Company Strategy and Development Direction - The company is focused on a return to growth strategy and building a diversified franchise as a life science tool provider and clinical partner [10] - The strategy includes vertical integration in the NAP segment to enhance quality, speed, and cost efficiency [8] - The company aims to expand its product and service portfolio to drive long-term sustainable growth [10] Management's Comments on Operating Environment and Future Outlook - Management acknowledged the challenges of transitioning from a COVID-driven revenue model to a more diversified business [39] - The company is closely monitoring trade dynamics and working to mitigate potential impacts from tariffs [39] - The cash position of $285 million is seen as sufficient to manage the reset period while focusing on long-term growth [40] Other Important Information - The company plans to publish its 2024 sustainability report, highlighting its commitment to sustainability and long-term strategic objectives [25] - The integration of recent acquisitions is progressing well, enhancing operational capabilities and supply chain control [32] Q&A Session Summary Question: Focus areas for new trials and reasons for discontinuation - Management noted that while preclinical programs were flat, clinical programs showed growth, indicating a focus on later-stage projects due to funding conservatism [44][46] Question: Drivers of incremental demand in the next 12-18 months - Incremental demand is expected from clinical progression, new business wins, and the transition from bulk reagent supply to comprehensive service offerings [48] Question: Opportunities for market share due to U.S. manufacturing - The company sees potential for market share growth as interest in U.S.-based manufacturing increases, particularly in the mRNA space [51][54] Question: Impact of U.S. policy changes on customer buying patterns - Customers are experiencing mixed impacts from government funding changes, with some securing long-term funding while others delay decisions [60] Question: Government work and exposure - The company has no direct government work currently, with past contracts fulfilled, but remains open to future opportunities [66] Question: Seasonality in BST revenue - Q1 is typically a high point for BST revenue, influenced by manufacturing cycles and strong performance in China [70][72]