Leading exome and genome products Translating complex genomic data into definitive diagnoses for patients Common diseases are in fact a constellation of genetic diagnoses 18Butler L. et al. Exome-based testing for patients with seizures: Advantages over panel-based testing. Poster presented at American Epilepsy SocietyAnnual Meeting; December 2, 2023; Orlando, FL. Data is at the center of our business Our huge dataset and intelligent interpretation platform set us apart and fuel innovation suboptimal care | ...

Reported fourth quarter 2023 revenue from continuing operations1 of $58.1M with more than 68% year-over-year growth of exome and genome test revenue Expanded fourth quarter 2023 adjusted gross margins2 from continuing operations to 56% Narrowed fourth quarter 2023 adjusted net loss2 to $17.8M and delivered 51% year-over-year cash burn reduction Issued guidance to deliver between $220M and $230M in FY 2024 revenue and reiterate path to profitability in 2025 GeneDx to host conference call today at 4:30 p.m. ...

STAMFORD, Conn., Jan. 24, 2024 (GLOBE NEWSWIRE) -- GeneDx, a leader in delivering improved health outcomes through genomic and clinical insights, today announced that, effective as of January 23, 2024, the compensation committee of GeneDx's board of directors granted newly hired employees 106,030 restricted stock units ("RSUs") as inducements material to each employee entering into employment with GeneDx. The RSUs were granted under GeneDx's 2023 Equity Inducement Plan and in accordance with Nasdaq Listing ...

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Financial Data and Key Metrics - Total revenues for Q3 2023 were $53.3 million, with revenues from continuing operations at $50.4 million, up from $47.2 million in Q3 2022 and $45.2 million in Q2 2023 [8] - Excluding a one-time appeal benefit in Q3 2022, revenues increased 14% YoY [8] - Whole exome and genome volume reached over 13,000 tests in Q3, a 71% YoY increase and 11% QoQ growth [8] - Revenue from exome and genome testing was $34 million, up 42% YoY and 18% QoQ [8] - Adjusted gross margin from continuing operations was 48% in Q3, up from 37% in Q2 [42] - Cash burn for continuing operations was approximately $25 million in Q3, with a 52% YoY reduction in cash burn [12][17] Business Line Data and Key Metrics - Exome and genome testing accounted for 63% of total revenue in September, with exome growth at 70% in Q3 [6][40] - The company is focusing on increasing exome and genome volumes, reducing claim denial rates, and driving down cash burn [6] - The company plans to retire about 350 tests in early 2024 to focus on differentiating tests that are best for patient care and positively impact the P&L [21] Market Data and Key Metrics - The company saw a 12% increase in clinicians ordering exomes in the outpatient setting, with neurology showing the fastest growth at 18% QoQ [40] - The rapid genome product in the inpatient setting is growing quickly, though it remains a small portion of the business [74] Company Strategy and Industry Competition - The company is transitioning the market from single-gene tests, multi-gene panels, and microarrays to exomes and genomes [6] - Automation and AI are being leveraged across review analysis, report writing, and genetic accounting steps to reduce costs [2] - The company has entered into a $75 million debt facility with Perceptive Advisors to strengthen its balance sheet and provide flexibility in 2025 [7][80] Management Commentary on Operating Environment and Future Outlook - The company expects to achieve profitability by the end of 2025, driven by rationalizing operating expenses, expanding gross margins, and revenue growth [9][44] - The company is confident in its ability to drive exome growth and improve reimbursement rates, with a focus on reducing claim denials [75] - The company is navigating a challenging market but remains committed to driving shareholder value through cost-effective growth [7] Other Important Information - The company has completed the consolidation of library preparation platforms to a lower-cost solution offered by Tuas Biosciences [2] - The company has implemented a cost reduction plan of approximately $40 million, including vendor spend and workforce reductions [13] - The company has brought in new leaders across commercial, operations, finance, and product and technology to drive efficiency and growth [15] Q&A Session Summary Question: What is driving the implied Q4 revenue guide reduction? - About half of the reduction is due to employee reductions, primarily in R&D, product and technology, and support functions [4] - The company is focusing on projects with shorter-term payoffs and has trimmed longer-term R&D pursuits [4] Question: How is the company addressing cost reductions and where will these be reflected in the P&L? - The $40 million cost reduction plan includes vendor spend and workforce reductions, with a focus on supporting exome and genome growth [13][22] - The reductions are primarily in R&D and support functions, with no impact on the sales force or MSL teams [23][51] Question: What is the outlook for ASPs and pricing in 2024? - The company expects ASPs to stabilize, with slight improvements in Q4 and incremental ASP improvements in exome over the next several quarters [20] - The company is focused on reducing denial rates to improve ASPs and revenue [75] Question: What is the progress on reducing claim denials? - The company has seen a slight reduction in the denial rate, which is currently in the low 60s, with efforts ongoing to further reduce denials [75] - The company is focusing on avoiding denied claims rather than relying on the lengthy appeals process [75] Question: What is the breakdown between inpatient and outpatient exome testing? - The vast majority (97-98%) of exome testing is in the outpatient setting, with rapid genome testing in the inpatient setting growing but still a small portion of the business [74] Question: How is the company thinking about capital allocation with the new debt agreement? - The new debt agreement is coupled with cost reduction actions to drive exome growth, improve reimbursement, and reduce costs, with capital allocated to support these priorities [64] Question: What is the outlook for gross margins? - The company expects gross margins to continue to improve as exome testing makes up a larger portion of revenue, with exome margins currently over 60% [16][90] - The company sees the Q3 gross margin of 48% as a base to build from, with no meaningful one-time items impacting the number [56]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Securities registered pursuant to Section 12(b) of the Act: For the quarterly period ended September 30, 2023 Commission file number 001-39482 GeneDx Holdings Corp. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) Delaware 85-1966622 ...

GeneDx Holdings Corp. (NASDAQ:WGS) Q2 2023 Results Conference Call August 8, 2023 4:30 PM ET Company Participants Tricia Truehart - Head, IR Katherine Stueland - President and CEO Kevin Feeley - CFO Conference Call Participants Mark Massaro - BTIG Matt Kim - Jefferies Prashant Kota - Goldman Sachs Dan Brennan - Cowen Operator Good day, and thank you for standing by. Welcome to the GeneDx Second Quarter 2023 Earnings Conference Call. [Operator Instructions] Be advised that today's conference is being recorde ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission file number 001-39482 GeneDx Holdings Corp. (Exact name of registrant as specified in its charter) Delaware 85-1966622 (Sta ...

Financial Data and Key Metrics - Q1 2023 revenue was $40.7 million, up from $38 million in Q1 2022, driven by a 22% growth in whole exome sequencing revenue [30] - Total test volumes increased by 8% sequentially and 29% year-over-year [30] - Adjusted gross margin for whole exome sequencing was approximately 60%, contributing to 17% of total volume in Q1 2023 [32] - Cash burn improved by 31% year-over-year to approximately $59 million in Q1 2023, with expectations of further reductions in subsequent quarters [35] - Total company adjusted net loss in Q1 2023 was $48.8 million, a 34% improvement compared to Q4 2022 [63] Business Line Data and Key Metrics - Whole exome and genome testing delivered $22.4 million in revenue, representing a 22% increase year-over-year in Q1 2023 [51] - Orders among neurologists and pediatric specialists were significantly higher compared to the previous year [24] - The company expanded sales territories from 58 to 66 across the United States and added cross-functional support teams to drive growth [24] - Non-exome tests, which serve as stepping stones to exome sequencing, saw increased volumes but carry lower average reimbursement rates and gross margins [60] Market Data and Key Metrics - The company expects to see margin expansion throughout 2023, with gross margins reaching the mid-40s by year-end [42] - Whole exome and genome testing is expected to become increasingly standard of care, particularly for cardiovascular and neurodegenerative diseases, allowing expansion into the adult population [50] - North Carolina Medicaid added coverage for exome sequencing, becoming the 28th state to do so, reflecting favorable payer trends [56] Company Strategy and Industry Competition - The company is focused on converting physicians to exome testing, leveraging non-exome tests as stepping stones [52] - Marketing efforts include conferences, publications, and brand awareness campaigns to educate clinicians and drive adoption [53] - Automation and AI are being implemented to improve turnaround times, reduce COGS, and expand gross margins [55] - Partnerships with biopharma companies are being pursued to leverage clinical and genomic data assets for drug discovery and development [28] Management Commentary on Operating Environment and Future Outlook - Management expects sequential improvements in cash burn, with Q4 2023 burn projected to be around $20 million [4] - The company reaffirmed its 2023 revenue guidance of $205 million to $220 million and expects to reach profitability by 2025 [37] - Management highlighted the growing market for genetic testing, with increased adoption by patients and physicians [14] - The company is optimistic about the favorable clinical and health-economic benefits of exome and genome sequencing, supported by medical societies and payers [27] Other Important Information - The company completed a reverse stock split at a 1 to 33 ratio, with all share-related figures retroactively adjusted [66] - In April 2023, the company issued an additional 1,378,328 shares as milestone payments related to the GeneDx acquisition [38] - The company signed data agreements with five companies focused on rare diseases or neurological disorders, leveraging its Centrella platform [57] Q&A Session Summary Question: Reconciliation of volume growth with revenue decline in single and multi-gene tests - The decline in revenue despite volume growth is attributed to lower realized ASPs, which are expected to improve as the year progresses [1][41] - Non-exome tests are seen as stepping stones to exome testing, with the sales team incentivized to drive this conversion [1][73] Question: Gross margin drivers and expectations for 2023 - Gross margins are expected to improve sequentially, driven by mix shift towards higher-margin tests, better reimbursement, and lab efficiencies [70][75] - The company aims to achieve mid-40s gross margins by year-end, up from 41% in Q4 2022 [42] Question: Cash burn and restructuring costs - A substantial portion of Q1 2023 cash burn was tied to restructuring, with remaining payments expected to wind down by Q2 2024 [4][76] - The company is focused on reducing G&A expenses and improving operational efficiency to further lower cash burn [4][76]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission file number 001-39482 GeneDx Holdings Corp. (Exact name of registrant as specified in its charter) (State or other jurisdi ...