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 - GeneDx reported third quarter 2025 revenues of $116.7 million, a 52% increase year over year [13] - 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 [20] Business Line Data and Key Metrics Changes - Revenue from exome and genome testing reached $98.9 million, up 66% from the same quarter last year [13] - The company performed 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 average reimbursement rate for exome and genome testing was over $3,800 in Q3, up from approximately $3,700 in the previous quarter [16] Market Data and Key Metrics Changes - GeneDx is the largest provider of rare disease diagnoses globally, with over 10,000 rare diseases impacting one in 10 Americans [8] - The NICU market remains underpenetrated, with less than 5% of NICU patients receiving genetic testing [9] - The company is expanding its presence in international markets, leveraging the Fabric Genomics platform [11] Company Strategy and Development Direction - GeneDx aims to drive high profitable growth, offer best-in-class diagnostics, and build network effects to usher in the next era of precision medicine [6] - The company is focused on expanding its sales force, nearly doubling it over the coming quarters [9] - GeneDx is investing in customer experience and medical education to drive utilization and adoption of its testing services [9][19] Management's Comments on Operating Environment and Future Outlook - Management raised 2025 revenue guidance to $425 to $428 million, reflecting strong momentum [5] - The company expects continued volume growth in exome and genome testing, with a forecast of at least 30% volume growth for the full year 2025 [22] - Management expressed confidence in maintaining profitability while investing in long-term growth initiatives [20][50] Other Important Information - The company discontinued its hereditary cancer offerings, which generated $1.2 million in Q3 2025 [22] - GeneDx received FDA breakthrough device designation for its ExomeDx and GenomeDx tests, validating its technology [7] Q&A Session Summary Question: Has there been an uptick in volume for chromosomal microarray testing? - Management noted that most pediatricians are hearing about updated guidelines for the first time from GeneDx, indicating a need for education [31] Question: What is the outlook for average selling prices and margins? - Management indicated that ASPs may decrease slightly in Q4 due to new market entries but emphasized that this impact should be transitory [34][36] Question: What is the growth outlook for the NICU market? - Management highlighted that NICU volumes are growing nicely and are expected to ramp significantly in the coming quarters [42][45] Question: What is the strategy for expanding the sales force? - Management confirmed plans to double the sales force and emphasized the importance of hiring the best talent available [53][54] Question: What is the expected impact of the FDA breakthrough designation? - Management explained that the designation signals the uniqueness of their test and facilitates an expedited regulatory review process [67][68]

Financial Data and Key Metrics Changes - The company reported third quarter 2025 revenues of $116.7 million, a 52% increase year over year [13] - Revenue from exome and genome testing was $98.9 million, up 66% from the same quarter last year [13] - Adjusted total operating expenses were $71 million, representing 61% of revenue for the quarter [18][20] - Adjusted net income for the quarter was $14.7 million, with adjusted basic EPS of $0.51 [20] Business Line Data and Key Metrics Changes - The company conducted 25,702 exome and genome tests in the third quarter, with growth accelerating to 33% year over year [13] - The average reimbursement rate for exome and genome tests was over $3,800, up from approximately $3,700 last quarter [16] - The company discontinued its hereditary cancer offerings, which generated $1.2 million in the third quarter of 2025 [21] Market Data and Key Metrics Changes - 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] - The company expects to see significant growth in the NICU channel, which is one of the fastest-growing segments [43] Company Strategy and Development Direction - The company is raising its 2025 revenue guidance to $425 to $428 million, reflecting strong momentum [4] - The strategy focuses on high profitable growth, best-in-class diagnostics, and building network effects to enhance precision medicine [5] - The company aims to deepen market penetration while expanding into new markets, including general pediatricians and international markets [8] Management's Comments on Operating Environment and Future Outlook - Management emphasized the importance of education and workflow improvements for pediatricians to drive testing adoption [31] - The company is optimistic about the future, with expectations for continued volume growth and profitability [22] - Management highlighted the FDA's breakthrough device designation as a validation of their technology and a catalyst for market expansion [66] Other Important Information - The company is investing in customer experience and medical education to drive utilization and expand its authority in genomics [9] - The company has a strong cash position with $156 million in cash, cash equivalents, and marketable securities as of September 30, 2025 [20] Q&A Session Summary Question: Has there been an uptick in volume for chromosomal microarray testing? - Management noted that most growth is coming from core markets, with no significant uptake in orders from pediatricians yet, but positive engagement is expected [31][32] Question: What is the outlook for average selling prices and margins? - Management indicated that average selling prices may decrease slightly due to new market entries but emphasized that this impact should be temporary [34][37] Question: What is the status of the NICU market? - Management confirmed that NICU volumes are growing nicely and are expected to contribute significantly to overall growth [40][43] Question: Can you elaborate on operating expenses and their impact on growth? - Management stated that operating expenses are strategic investments aimed at driving long-term growth, with expectations for continued increases in the near term [48][49] Question: What is the strategy for expanding Medicaid coverage? - Management highlighted the recent expansion of Medi-Cal coverage for whole genome testing and plans to secure coverage in additional states [80]

Core Insights - GeneDx Holdings Corp. reported quarterly earnings of $0.49 per share, exceeding the Zacks Consensus Estimate of $0.28 per share, and showing a significant increase from $0.04 per share a year ago, resulting in an earnings surprise of +75.00% [1] - The company achieved revenues of $116.74 million for the quarter ended September 2025, surpassing the Zacks Consensus Estimate by 12.47% and increasing from $76.87 million year-over-year [2] - GeneDx Holdings has consistently outperformed consensus EPS and revenue estimates over the last four quarters [2] Earnings Outlook - The sustainability of the stock's price movement will depend on management's commentary during the earnings call and future earnings expectations [3] - The current consensus EPS estimate for the upcoming quarter is $0.51 on revenues of $116.5 million, and for the current fiscal year, it is $1.56 on revenues of $410.1 million [7] Industry Context - The Medical Services industry, to which GeneDx Holdings belongs, is currently ranked in the top 38% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5]

Financial Performance - GeneDx grew revenues to $116.7 million, a 52% increase year-over-year[4] - Exome and genome test revenue grew to $98.9 million, a 65% increase year-over-year[4] - The company delivered an adjusted gross margin of 74%, up from 64% in the third quarter of 2024[4] - Adjusted net income was $14.7 million in the third quarter of 2025[4] - Cash, cash equivalents, marketable securities, and restricted cash were $156.1 million as of September 30, 2025[13] Business Highlights - The company's exome and genome volume grew 33% year-over-year[10] - Exome and genome tests accounted for 43% of all tests reported[10] - GeneDx received FDA Breakthrough Device Designation for the GeneDx ExomeDx and GenomeDx[6] Strategic Initiatives and Market Expansion - GeneDx is participating in the NIH's BEACONS Initiative and Florida's Sunshine Genetics Network for genomic newborn screening[6] - The company is strategically investing to accelerate long-term growth drivers, with Q3 2025 adjusted total operating expenses of $71 million[14, 17] - Medicaid programs are expanding access to exome and genome sequencing, with 36 states covering exome or genome testing and 17 states covering rapid genome sequencing[63] Guidance - The company updated its full-year 2025 revenue guidance to $425 to $428 million[18] - The company expects growth in exome and genome revenue of 53% to 55%[18]

Revenue Growth - Total revenue for the three months ended September 30, 2025, was $116.743 million, a 52% increase from $76.874 million in the same period of 2024[15] - Diagnostic test revenue reached $113.523 million for the three months ended September 30, 2025, compared to $77.418 million in the prior year, reflecting a 46% year-over-year growth[15] - Pro forma revenues for the three months ended September 30, 2025, were $116.7 million, compared to $78.1 million for the same period in 2024, indicating a significant increase[52] - Total diagnostic test revenue for the nine months ended September 30, 2025, was $299.382 million, a significant increase from $207.961 million in the same period of 2024, representing a growth of approximately 44%[55] - Revenue from patients with third-party insurance reached $244.183 million for the nine months ended September 30, 2025, compared to $155.434 million in 2024, marking an increase of about 57%[55] - The GeneDx operating segment generated $303.596 million in revenue for the nine months ended September 30, 2025, compared to $207.007 million for the same period in 2024, a growth of 46.6%[128] Profitability and Loss - Gross profit for the nine months ended September 30, 2025, was $213.905 million, up from $128.192 million in the same period of 2024, indicating a significant increase in profitability[15] - The company reported a net loss of $7.635 million for the three months ended September 30, 2025, compared to a net loss of $8.312 million in the same period of 2024[15] - For the three months ended September 30, 2025, the net loss was $7,635 thousand, compared to a net loss of $3,355 thousand for the same period in 2024[18] - The net loss attributable to common stockholders for the three months ended September 30, 2025, was $7.635 million, compared to a loss of $8.312 million in the same period of 2024[121] - The basic and diluted loss per share for the three months ended September 30, 2025, was $(0.27), an improvement from $(0.31) in the same period of 2024[121] Expenses - Research and development expenses for the three months ended September 30, 2025, were $19.829 million, up from $11.665 million in the same period of 2024, representing a 70% increase[15] - Selling and marketing expenses increased to $23.510 million for the three months ended September 30, 2025, compared to $17.025 million in the prior year, a rise of 38%[15] - Stock-based compensation expense for the nine months ended September 30, 2025, was $22,382 thousand, significantly higher than $6,293 thousand for the same period in 2024[21] - Stock-based compensation expense for the three months ended September 30, 2025, totaled $10.586 million, a significant increase from $3.636 million in the same period of 2024[102] Assets and Liabilities - Total assets increased to $493.902 million as of September 30, 2025, up from $419.380 million at the end of 2024, showing a growth of approximately 17.7%[14] - Cash and cash equivalents rose to $95.968 million as of September 30, 2025, compared to $85.212 million at the end of 2024, reflecting a 12.6% increase[14] - The company’s accumulated deficit stood at $1.355829 billion as of September 30, 2025, slightly increasing from $1.352474 billion at the end of 2024[14] - The total stockholders' equity increased to $292,258 thousand as of September 30, 2025, up from $277,133 thousand at June 30, 2025[18] - Total liabilities increased from $20.498 million as of December 31, 2024, to $32.858 million as of September 30, 2025, representing a rise of 60.5%[124] Acquisitions and Strategic Direction - The company acquired Fabric Genomics on May 5, 2025, enhancing its capabilities in genomics[24] - The Company completed the acquisition of Fabric Genomics for approximately $33.5 million, enhancing its AI capabilities in Next Generation Sequencing analysis[44] - The Company incurred $1.4 million in transaction costs related to the acquisition during the nine months ended September 30, 2025[49] - The company plans to pursue a new strategic direction, which includes exiting certain business segments to improve gross margins[12] Financial Instruments and Market Conditions - The fair value of financial assets as of September 30, 2025, totaled $126.572 million, with money market funds accounting for $67.713 million and U.S. treasury bonds for $26.860 million[61] - The Company entered into a Credit Agreement on October 27, 2023, providing a senior secured delayed draw term loan facility of up to $75.0 million, with an initial tranche of $50.0 million funded[73][84] - The Perceptive Term Loan Facility has a maturity date of October 27, 2028, with an interest-only period and principal due at maturity, net proceeds from the initial tranche were approximately $48.8 million[85][86] - A 100-basis point change in interest rates is not expected to have a material effect on the fair market value of the Company’s cash, cash equivalents, and restricted cash[199] Stock and Equity - The Company issued common stock in an ATM offering, net of issuance costs, totaling $11,802 thousand for the three months ended September 30, 2025[18] - The total fair value of restricted stock units vested during the nine months ended September 30, 2025, was $8.5 million[113] - The number of Class A common stock reserved for future issuance under the 2021 Equity Incentive Plan increased by 1,400,827 shares in January 2025[104] - The Company issued 22,674 shares of Class A common stock under the 2021 Employee Stock Purchase Plan during the nine months ended September 30, 2025[116] - The total number of shares of Class A common stock reserved for future issuance under the 2021 Employee Stock Purchase Plan as of September 30, 2025, was 827,322 shares[116]

Financial Performance - Reported revenues for Q3 2025 were $116.7 million, representing a 52% year-over-year increase[8] - Exome and genome test revenue reached $98.9 million, a 65% increase year-over-year, with test volume growing to 25,702, up 33% year-over-year[7] - Total revenue for Q3 2025 was $116.743 million, up 52.0% from $76.874 million in Q3 2024[27] - Diagnostic test revenue for Q3 2025 reached $113.523 million, a 46.5% increase from $77.418 million in Q3 2024[27] - Adjusted net income for Q3 2025 was $14.7 million, compared to $2.0 million in Q3 2024, while GAAP net loss was $7.6 million[9] - The net loss for Q3 2025 was $7.635 million, a slight improvement from a net loss of $8.312 million in Q3 2024[27] - Basic and diluted loss per share for Q3 2025 was $0.27, compared to $0.31 in Q3 2024[27] - Net loss for the nine months ended September 30, 2025, was $3.355 million, a significant improvement from a net loss of $57.724 million in the same period of 2024[29] Margins and Expenses - Adjusted gross margin expanded to 74%, up from 64% in Q3 2024, while GAAP gross margin was 72%[5] - Gross profit for Q3 2025 was $84.527 million, resulting in a gross margin of 72.4%, compared to a gross margin of 62.2% in Q3 2024[27] - Research and development expenses increased to $19.829 million in Q3 2025, up from $11.665 million in Q3 2024, reflecting a 70.0% increase[27] - Stock-based compensation expense rose significantly to $22.382 million from $6.293 million in the prior year[29] - The company reported a depreciation and amortization expense of $18.343 million, up from $16.395 million in the previous year[29] Cash and Assets - Cash position as of September 30, 2025, was $156.1 million, with $8.8 million in free cash flow generated during Q3 2025[12] - Total current assets as of September 30, 2025, were $237.583 million, an increase from $197.968 million as of December 31, 2024[25] - Total assets increased to $493.902 million as of September 30, 2025, compared to $419.380 million as of December 31, 2024[25] - Cash, cash equivalents, and restricted cash at the end of the period totaled $96.958 million, up from $58.881 million at the end of the previous year[29] - Net cash provided by operating activities was $36.369 million, compared to a net cash used of $25.313 million in the prior year[29] Liabilities and Equity - Total liabilities as of September 30, 2025, were $201.644 million, up from $174.133 million as of December 31, 2024[25] - Stockholders' equity increased to $292.258 million as of September 30, 2025, compared to $245.247 million as of December 31, 2024[25] Business Developments - GeneDx is the sole commercial testing provider for new genomic newborn screening programs, including the NIH BEACONS initiative[7] - FDA granted Breakthrough Device Designation for GeneDx ExomeDx™ and GenomeDx™ tests, enhancing the company's leadership in genomic medicine[14] - Introduced GeneDx Infinity, the largest rare disease dataset, which supports the ExomeDx™ and GenomeDx™ tests[13] - Expanded coverage of whole genome sequencing with California Medicaid, increasing access to testing in the most populous state[13] Guidance and Future Outlook - Full year 2025 revenue guidance raised to between $425 million and $428 million, with expected growth in exome and genome revenue between 53% to 55%[11] - The company incurred $33.195 million for the acquisition of a business, net of cash acquired[29] - Proceeds from offerings, net of issuance costs, amounted to $25.568 million, an increase from $14.589 million in the prior year[29] - Cash paid for interest was $4.835 million, slightly down from $5.035 million in the previous year[29] - Cash paid for taxes increased to $1.039 million from $910,000 in the prior year[29] - The company experienced a change in accounts receivable of $(22.799) million, compared to $(5.850) million in the previous year[29]

Core Insights - GeneDx Holdings Corp. reported strong financial results for Q3 2025, highlighting significant growth in revenue and test volumes, alongside improved gross margins [2][4][7]. Financial Performance - Revenues reached $116.7 million, marking a 52% increase year-over-year [8]. - Exome and genome test revenue grew to $98.9 million, reflecting a 65% year-over-year increase [8]. - Adjusted gross margin expanded to 74%, up from 64% in Q3 2024, while GAAP gross margin was reported at 72% [4][8]. - Adjusted net income for Q3 2025 was $14.7 million, compared to $2.0 million in the same quarter of 2024 [5][8]. Operational Highlights - The volume of exome and genome tests increased to 25,702, a 33% year-over-year growth [8]. - Exome and genome tests accounted for 43% of all tests performed, up from 33% in Q3 2024 [8]. - Adjusted total operating expenses were $71.2 million, representing 61% of revenue, a slight decrease from 62% in Q3 2024 [8]. Strategic Developments - GeneDx received FDA Breakthrough Device Designation for its ExomeDx™ and GenomeDx™ tests, emphasizing its innovative leadership in genomic diagnostics [3][7]. - The company is leading in genomic newborn screening, being the sole commercial testing provider for new programs, including the NIH BEACONS initiative [7][13]. - GeneDx introduced GeneDx Infinity™, the largest rare disease dataset, enhancing its capabilities in rare disease insights [13][15]. Guidance and Future Outlook - GeneDx raised its full-year 2025 revenue guidance to between $425 million and $428 million, with expected growth in exome and genome revenue between 53% to 55% [7][9]. - The company anticipates continued volume growth of at least 30% for exome and genome tests [9].

Core Insights - GeneDx Holdings Corp. reported strong financial results for Q3 2025, highlighting significant growth in genomic testing and improved profitability metrics [2][7][8] - The company received FDA Breakthrough Device Designation for its ExomeDx™ and GenomeDx™ tests, emphasizing its leadership in genomic medicine [3][7][24] Financial Performance - Revenues reached $116.7 million, representing a 52% year-over-year increase [8] - Exome and genome test revenue grew to $98.9 million, a 65% increase year-over-year [8] - Adjusted gross margin expanded to 74%, up from 64% in Q3 2024, while GAAP gross margin was reported at 72% [4][8] - Adjusted net income for Q3 2025 was $14.7 million, compared to $2.0 million in Q3 2024, while GAAP net loss was $7.6 million [5][8] Operational Highlights - The volume of exome and genome tests increased by 33% year-over-year, totaling 25,702 tests [8] - Adjusted total operating expenses were $71.2 million, representing 61% of revenue, a slight decrease from 62% in Q3 2024 [8] - The company ended the quarter with a cash position of $156.1 million, including $8.8 million in free cash flow generated [8] Strategic Initiatives - GeneDx raised its full-year 2025 revenue guidance to between $425 million and $428 million, with expected growth in exome and genome revenue between 53% to 55% [7][9] - The company is leading genomic newborn screening initiatives, including participation in the NIH BEACONS initiative and a partnership with Florida's Sunshine Genetics Network [13] - GeneDx introduced GeneDx Infinity™, the largest rare disease dataset, enhancing its genomic testing capabilities [13][15] Market Position - GeneDx is positioned as a leader in genomic newborn screening, being the sole commercial testing provider for new programs [7][13] - The company is actively expanding its market presence and investing in sustainable growth with attractive margins [6][7]

Group 1 - GeneDx Holdings is highlighted as a leading stock in the IBD 50 Growth Stocks To Watch, showing a significant climb in a seven-week-long consolidation pattern ahead of its earnings report [1] - The company turned profitable in 2024, with analysts projecting substantial earnings growth for its third quarter [1] - GeneDx has recently been recognized as an IBD Breakout stock, indicating strong market performance [1] Group 2 - The stock is expected to achieve a remarkable 954% growth following its FDA Breakthrough Device Designation [2] - GeneDx has seen a 36% increase in stock price over the past two days, reflecting strong investor interest [4] - The company has cleared technical benchmarks, achieving a 90-plus Relative Strength (RS) Rating [4]