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GeneDx Reports First Quarter 2024 Financial Results and Business Highlights

Reported first quarter 2024 revenue from continuing operations1 of $61.5M with 96% year-over-year growth of exome and genome test revenue Expanded first quarter 2024 adjusted gross margins2 from continuing operations to 61% Narrowed first quarter 2024 adjusted net loss2 to $8.5M and delivered 71% year-over-year cash burn reduction Raised guidance to deliver between $235M and $245M in FY 2024 revenue and reiterate path to profitability in 2025 GeneDx to host conference call today at 4:30 p.m. ET STAMFORD, Conn., April 29, 2024 (GLOBE NEWSWIRE) -- GeneDx Holdings Corp. (NASDAQ:WGS), a leader in delivering improved health outcomes through genomic insights, today reported its financial results for the first quarter of 2024. "Our strong first quarter results reflect our continued dedication to our three key organizational focuses: growing exome and genome revenue, increasing our average reimbursement rates while expanding access to testing, and meaningfully reducing our cash burn," said Katherine Stueland, Chief Executive Officer of GeneDx. "Our team's successful execution in the first quarter gives us the confidence to raise full year 2024 revenue guidance to between $235-$245 million and reiterate our expectation to reach profitability in 2025." First Quarter 2024 Financial Results (Unaudited)1,2 Revenues Revenues from continuing operations grew to $61.5 million, an increase of 51% year-over-year and 6% sequentially. Total company revenues were $62.4 million. Exome and genome test revenue grew to $44.0 million, an increase of 96% year-over-year and 12% sequentially. Exome and genome volume Exome and genome test results volume grew to 16,592, an increase of 91% year-over-year and 6% sequentially. Exome and genome represented 30% of all test results, up from 16% in the first quarter of 2023 and up from 27% in the fourth quarter of 2023. Gross margin Adjusted gross margin from continuing operations expanded to 61%, up from 34% in the first quarter of 2023 and up from 56% in the fourth quarter of 2023. Total company gross margin was 60%. Exome and genome adjusted gross margin operated in excess of 65%. Operating expenses Adjusted total operating expenses reduced to $45.4 million, a decrease of 26% year-over-year and 6% sequentially. Total GAAP operating expenses were $50.1 million. Net loss Adjusted net loss narrowed to $8.5 million, an improvement of 83% year-over-year and 52% sequentially. GAAP net loss was $20.2 million. Cash burn and cash position Total net use of cash was $17.2 million in the first quarter of 2024, an improvement of 71% year-over-year and 48% sequentially. Cash, cash equivalents, marketable securities and restricted cash was $113.9 million as of March 31, 2024. Revenue and gross margin results from continuing operations, which we believe are representative of our ongoing business strategy exclude any revenue and cost of goods sold of the exited Legacy Sema4 diagnostic testing business for the current and all comparative periods. Total company results include GeneDx's continuing operations and the financial impacts of exited Legacy Sema4 business activities for the current and all comparative periods. Adjusted gross margin, adjusted total operating expenses and adjusted net loss are non-GAAP financial measures. See appendix for a reconciliation of GAAP to Non-GAAP figures presented. Updated GeneDx Full Year 2024 Guidance GeneDx has updated its full year 2024 guidance. Management expects GeneDx to: Drive full year 2024 revenues between $235 and $245 million (previous guidance was $220 to $230 million); Expand full year 2024 adjusted gross margin profile to at least 60% (previous guidance was at least 50%); Use $70 to $80 million of net cash for full year 2024 (previous guidance was $75 to $80 million); Turn profitable in 2025 (no change). First Quarter 2024 Business Highlights Driving sustainable growth and market leadership Reached new milestone of sequencing 600k clinical exomes and genomes since inception, with over half sequenced since July 2021 and 100k sequenced since the fall. This continued acceleration of exome and genome sequencing and interpretation further solidifies GeneDx's industry leadership, enhances the robustness of its proprietary dataset, and enables more definitive diagnoses for more patients. Presented new data at the American College of Medical Genetics and Genomics Annual Meeting further demonstrating the clinical superiority of exome compared to chromosomal microarray ("CMA"), supporting our efforts to eliminate the need for CMA to be ordered when exome is ordered first. State Medicaid programs continue to expand coverage of rapid genetic testing in the neonatal intensive care unit ("NICU"), bringing total states covering rapid whole genome in the acute care setting to 11, including new coverage announced in: Georgia (January 2024) South Dakota (March 2024) New York added outpatient whole exome sequencing ("WES") coverage to their Medicaid plan, effective April 1, 2024, bringing total states covering WES to 28. Grew biopharma partner programs to 21, predominantly with biotech companies who are relying on us to find patients with a specific variant for clinical trial purposes. Launched a strategic partnership with Komodo Health, a premier healthcare technology company for the pharmaceutical industry, enabling improved access to genetic insights that can help inform drug pipelines and accelerate clinical trial enrollment for biopharma partners. Webcast and Conference Call Details GeneDx will host a conference call today, April 29, 2024, at 4:30 p.m. Eastern Time. Investors interested in listening to the conference call are required to register online. A live and archived webcast of the event will be available on the "Events" section of the GeneDx investor relations website at https://ir.genedx.com/. Forward-Looking Statements This press release 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 2024 reported revenue guidance, our expectations regarding our adjusted gross margin profile in 2024, our use of net cash in 2024 and our turning profitable in 2025. These forward-looking statements generally are identified by the words "believe," "project," "expect," "anticipate," "estimate," "intend," "strategy," "future," "opportunity," "plan," "may," "should," "will," "would," "will be," "will continue," "will likely result," and similar expressions. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, including but not limited to: (i) our ability to implement business plans, goals and forecasts, and identify and realize additional opportunities, (ii) the risk of downturns and a changing regulatory landscape in the highly competitive healthcare industry, (iii) the size and growth of the market in which we operate, (iv) our ability to pursue our new strategic direction, and (vi) our ability to enhance our artificial intelligence tools that we use in our clinical interpretation platform. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission (the "SEC") on February 23, 2024 and other documents filed by us from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and we assume no obligation and do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. We do not give any assurance that we will achieve our expectations. About GeneDx At GeneDx (NASDAQ:WGS), we believe that everyone deserves personalized, targeted medical care—and that it all begins with a genetic diagnosis. Fueled by one of the world's largest rare disease data sets, our industry-leading exome and genome tests translate complex genomic data into clinical answers that unlock personalized health plans, accelerate drug discovery, and improve health system efficiencies. It all starts with a single test. For more information, please visit genedx.com and connect with us on LinkedIn, X, Facebook, and Instagram. Investor Relations Media Volume and revenue in the table below include the combination of the Legacy GeneDx diagnostic business with the data and information business of Legacy Sema4. Volume & Revenue   1Q24   4Q23   3Q23   2Q23   1Q23 Volumes                   Whole exome, whole genome   16,592       15,663       13,216       11,855       8,705   Hereditary cancer   6,868       8,240       8,556       7,142       7,120   Other panels   31,763       33,692       35,861       35,931       36,953   Total   55,223       57,595       57,633       54,928       52,778                       Revenue ($ millions)                   Whole exome, whole genome $ 44.0     $ 39.2     $ 34.0     $ 28.7     $ 22.4   Hereditary cancer   5.5       5.5       4.5       3.8       4.3   Other panels   10.7       11.2       10.6       10.6       12.7   Data information   1.3       2.2       1.3       2.1       1.3   Total $ 61.5     $ 58.1     $ 50.4     $ 45.2     $ 40.7                                           Unaudited Select Financial Information (in thousands)   Three months ended March 31, 2024   Three months ended December 31, 2023   GeneDx   Legacy Sema4   Total   GeneDx   Legacy Sema4   Total Revenue $ 61,461     $ 961     $ 62,422     $ 58,107     $ (689 )   $ 57,418   Adjusted cost of services   24,099       —       24,099       25,626       —       25,626   Adjusted gross profit (loss) $ 37,362     $ 961     $ 38,323     $ 32,481     $ (689 )   $ 31,792   Adjusted gross margin %   60.8 %     (100.0 )%     61.4 %     55.9 %     100.0 %     55.4 %                                                   Three months ended March 31, 2023   GeneDx   Legacy Sema4   Total Revenue $ 40,693     $ 2,446     $ 43,139   Adjusted cost of services   26,826       2,080       28,906   Adjusted gross profit (loss) $ 13,867     $ 366     $ 14,233   Adjusted gross margin %   34.1 %     15.0 %     33.0 %                           Three months ended March 31, 2024   Reported   Depreciation and amortization   Stock-based compensation expense   Restructuring costs   Change in FV of financial liabilities   Charges related to business exit   Other   Adjusted Diagnostic test revenue $ 61,104     $ —     $ —     $ —     $ —     $ —     $ —     $ 61,104   Other revenue   1,318       —       —       —       —       —       —       1,318   Total revenue   62,422       —       —       —       —       —       —       62,422   Cost of services   25,011       (816 )     (48 )     (48 )     —       —       —       24,099   Gross profit (loss)   37,411       816       48       48       —       —       —       38,323   Gross margin   59.9 %                             61.4 % Research and development   11,567       (196 )     187       (103 )     —       —       —       11,455   Selling and marketing   16,085       (1,225 )     20       (400 )     —       —       —       14,480   General and administrative   22,445       (3,011 )     292       (292 )     —       —       —       19,434   Impairment loss   —       —       —       —       —       —       —       —   Other, net   974