STAMFORD, Conn.--(BUSINESS WIRE)--GeneDx Holdings Corp. (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today reported its financial results for the second quarter of 2024.
"Our continued organizational focus on execution fueled our strong second quarter results, giving us confidence to raise full year 2024 revenue guidance to between $255-$265 million and reiterate our expectation to reach profitability in the next several quarters," said Katherine Stueland, President and Chief Executive Officer at GeneDx. "The strength in our performance across all measures of the business has enabled us to begin investments in future growth opportunities for our business with a focus on extending our leadership in whole exome sequencing to whole genome sequencing to ensure we continue to lead the charge in quickly providing the most accurate and actionable genetic information to diagnose disease for as many patients and families as possible."
Second Quarter 2024 Financial Results (Unaudited)1,2
Revenues
- Revenues from continuing operations grew to $68.9 million, an increase of 52% year-over-year and 12% sequentially.
- Total company revenues were $70.5 million.
- Exome and genome test revenue grew to $50.7 million, an increase of 77% year-over-year and 15% sequentially.
Exome and genome volume
- Exome and genome test results volume grew to 18,017, an increase of 52% year-over-year and 9% sequentially.
- Exome and genome represented 31% of all test results, up from 22% in the second quarter of 2023 and up from 30% in the first quarter of 2024.
Gross margin
- Adjusted gross margin from continuing operations expanded to 62%, up from 37% in the second quarter of 2023 and up from 61% in the first quarter of 2024.
- Total company gross margin was 61%.
Operating expenses
- Adjusted total operating expenses reduced to $45.0 million, a decrease of 24% year-over-year and 1% sequentially.
- Total GAAP operating expenses were $52.7 million.
Net loss
- Adjusted net loss narrowed to $2.7 million, an improvement of 93% year-over-year and 68% sequentially.
- GAAP net loss was $29.2 million, inclusive of a one-time, net litigation charge of $13 million.
Cash burn and cash position
- Total net use of cash was $6.1 million in the second quarter of 2024, an improvement of 89% year-over-year and 65% sequentially.
- Cash, cash equivalents, marketable securities and restricted cash was $107.8 million as of June 30, 2024.
| 1. | 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. | ||
| 2. | 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. |
GeneDx Full Year 2024 Guidance
GeneDx has updated full year 2024 guidance. Management expects GeneDx to:
- Drive full year 2024 revenues1 between $255 and $265 million (previous guidance was between $235 and $245 million);
- Expand full year 2024 adjusted gross margin profile to at least 60% (no change);
- Use between $65 to $70 million of net cash for full year 2024 (previous guidance was between $70 to $80 million);
- Turn to profitability in 2025 (no change).
| 1. | Total company results include the combination of the GeneDx diagnostic business revenues and the data and information revenues from the Legacy Sema4 business. |
Second Quarter 2024 Business Highlights
Driving sustainable growth, expanding access and improving the standard of care
- Announced collaboration with Epic Aura1 to expand access to rapid whole genome sequencing ("rWGS") services to inform diagnosis for affected pediatric and neonatal patients, enhancing GeneDx's commercial footprint within leading health systems.
- Launched first-of-its-kind Patient Access Program in collaboration with leading biopharma partners to expand access to exome testing for pediatric epilepsy patients.
- Grew biopharma partner programs to 32, predominantly with biotech companies who are relying on us to find patients with a specific variant for clinical trial purposes.
- North Carolina Medicaid has expanded its existing coverage of outpatient whole exome sequencing ("WES") to include the analysis of family comparator samples, which increases the rate of diagnosis of WES, effective June 1, 2024.
- State Medicaid programs continue to expand coverage of rapid genome sequencing in the neonatal intensive care unit ("NICU"), bringing total states covering rapid whole genome in the acute care setting to 14, including new coverage announced in:
- North Carolina (June 2024)
- Tennessee (July 2024)
- Connecticut (July 2024)
- Announced reinvestment in rapid and standard whole genome sequencing products, enabling:
- Faster turnaround time for rWGS with a written report in as fast as 5 days
- Buccal samples (cheek swab) allowing for easier and more accessible non-invasive sample collection method for even the youngest patients
- Expanding the number of repeat expansions covered by whole genome sequencing to increase diagnostic yield and improve the provider and patient experience by decreasing the need for follow-up testing
| 1. | Epic and Aura are trademarks of Epic Systems Corporation. |
Webcast and Conference Call Details
GeneDx will host a conference call today, July 30, 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 (v) 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.
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
2Q24 | 1Q24 | 4Q23 | 3Q23 | 2Q23 | ||||||||||
Volumes | ||||||||||||||
Whole exome, whole genome | 18,017 | 16,592 | 15,663 | 13,216 | 11,855 | |||||||||
Hereditary cancer | 5,482 | 6,868 | 8,240 | 8,556 | 7,142 | |||||||||
Other panels | 34,204 | 31,763 | 33,692 | 35,861 | 35,931 | |||||||||
Total | 57,703 | 55,223 | 57,595 | 57,633 | 54,928 | |||||||||
Revenue ($ millions) | ||||||||||||||
Whole exome, whole genome | $ | 50.7 | $ | 44.0 | $ | 39.2 | $ | 34.0 | $ | 28.7 | ||||
Hereditary cancer | 3.8 | 5.5 | 5.5 | 4.5 | 3.8 | |||||||||
Other panels | 13.3 | 10.7 | 11.2 | 10.6 | 10.6 | |||||||||
Data information | 1.1 | 1.3 | 2.2 | 1.3 | 2.1 | |||||||||
Total | $ | 68.9 | $ | 61.5 | $ | 58.1 | $ | 50.4 | $ | 45.2 | ||||
Unaudited Select Financial Information (in thousands)
| Three months ended June 30, 2024 | Three months ended March 31, 2024 | |||||||||
GeneDx | Legacy Sema4 | Total | GeneDx | Legacy Sema4 | Total | ||||||
Revenue | $68,924 | $1,590 | $70,514 | $61,461 | $961 | $62,422 | |||||
Adjusted cost of services | 26,523 | 145 | 26,668 | 24,099 | - | 24,099 | |||||
Adjusted gross profit (loss) | $42,401 | $1,445 | $43,846 | $37,362 | $961 | $38,323 | |||||
Adjusted gross margin % | 61.5% | 90.9% | 62.2% | 60.8% | 100.0% | 61.4% | |||||
Three months ended June 30, 2023 | |||||
GeneDx | Legacy Sema4 | Total | |||
Revenue | $45,226 | $3,480 | $48,706 | ||
Adjusted cost of services | 28,452 | - | 28,452 | ||
Adjusted gross profit (loss) | $16,774 | $3,480 | $20,254 | ||
Adjusted gross margin % | 37.1% | 100.0% | 41.6% | ||
Three months ended June 30, 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 | $ |
69,439 | $ | - | $ | - | $ | - | $ | - | $ | - | $ | - | $ | 69,439 | ||||||||||||
Other revenue | 1,075 | - | - | - | - | - | - | 1,075 | ||||||||||||||||||||
Total revenue | 70,514 | - | - | - | - | - | - | 70,514 | ||||||||||||||||||||
Cost of services | 27,562 | (808 | ) | (86 | ) | - | - | - | - | 26,668 | ||||||||||||||||||
Gross profit (loss) | 42,952 | 808 | 86 | - | - | - | - | 43,846 | ||||||||||||||||||||
Gross margin | 60.9 | % | 62.2 | % | ||||||||||||||||||||||||
Research and development | 10,902 | (211 | ) | (347 | ) | (35 | ) | - | - | - | 10,309 | |||||||||||||||||
Selling and marketing | 16,585 | (1,225 | ) | (368 | ) | (63 | ) | - | - | - | 14,929 | |||||||||||||||||
General and administrative | 25,170 | (2,974 | ) | (2,307 | ) | (150 | ) | - | - | - | 19,739 | |||||||||||||||||
Impairment loss | - | - | - | - | - | - | - | - | ||||||||||||||||||||
Other, net | 874 | - | - | - | - | - | - | 874 | ||||||||||||||||||||
Loss from operations | (10,579 | ) | 5,218 | 3,108 | 248 | - | - | - | (2,005 | ) | ||||||||||||||||||
Interest income (expense), net | (894 | ) | - | - | - | - | - | - | (894 | ) | ||||||||||||||||||
Other income (expense), net | (17,890 | ) | - | - | - | 4,409 | - | 13,450 | (31 | ) | ||||||||||||||||||
Income tax benefit | 190 | - | - | - | - | - | - | 190 | ||||||||||||||||||||
Net loss | $ | (29,173 | ) | $ | 5,218 | $ | 3,108 | $ | 248 | $ | 4,409 | $ | - | $ | 13,450 | $ | (2,740 | ) | ||||||||||
Three months ended June 30, 2023 | |||||||||||||||||||||||||||||||
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 | $ | 46,635 | $ | - | $ | - | $ | - | $ | - | $ | - | $ | - | $ | 46,635 | |||||||||||||||
Other revenue | 2,071 | - | - | - | - | - | - | 2,071 | |||||||||||||||||||||||
Total revenue | 48,706 | - | - | - | - | - | - | 48,706 | |||||||||||||||||||||||
Cost of services | 29,949 | (1,233 | ) | (251 | ) | (13 | ) | - | - | - | 28,452 | ||||||||||||||||||||
Gross profit (loss) | 18,757 | 1,233 | 251 | 13 | - | - | - | 20,254 | |||||||||||||||||||||||
Gross margin | 38.5 | % | 41.6 | % | |||||||||||||||||||||||||||
Research and development | 17,138 | (4,656 | ) | 675 | (815 | ) | - | - | - | 12,342 | |||||||||||||||||||||
Selling and marketing | 15,182 | (1,225 | ) | 143 | (326 | ) | - | - | - | 13,774 | |||||||||||||||||||||
General and administrative | 37,341 | (3,218 | ) | (675 | ) | (483 | ) | - | - | - | 32,965 | ||||||||||||||||||||
Impairment loss | - | - | - | - | - | - | - | - | |||||||||||||||||||||||
Other, net | 718 | - | - | - | - | 334 | 3,238 | 4,290 | |||||||||||||||||||||||
Loss from operations | (51,622 | ) | 10,332 | 108 | 1,637 | - | (334 | ) | (3,238 | ) | (43,117 | ) | |||||||||||||||||||
Interest income (expense), net | 1,074 | - | - | - | - | - | - | 1,074 | |||||||||||||||||||||||
Other income (expense), net | 3,633 | - | - | - | (3,547 | ) | - | (86 | ) | - | |||||||||||||||||||||
Income tax benefit | 196 | - | - | - | - | - | - | 196 | |||||||||||||||||||||||
Net loss | $ | (46,719 | ) | $ | 10,332 | $ | 108 | $ | 1,637 | $ | (3,547 | ) | $ | (334 | ) | $ | (3,324 | ) | $ | (41,847 | ) | ||||||||||
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 | - | - | - | - | - | - | 974 | ||||||||||||||||||||
Loss from operations | (13,660 | ) | 5,248 | (451 | ) | 843 | - | - | - | (8,020 | ) | |||||||||||||||||
Interest income (expense), net | (597 | ) | - | - | - | - | - | - | (597 | ) | ||||||||||||||||||
Other income (expense), net | (6,064 | ) | - | - | - | 6,101 | - | - | 37 | |||||||||||||||||||
Income tax benefit | 82 | - | - | - | - | - | - | 82 | ||||||||||||||||||||
Net loss | $ | (20,239 | ) | $ | 5,248 | $ | (451 | ) | $ | 843 | $ | 6,101 | $ | - | $ | - | $ | (8,498 | ) | |||||||||
GeneDx Holdings Corp. Condensed Consolidated Balance Sheets (in thousands, except share and per share amounts) | |||||||
June 30, 2024 (Unaudited) | December 31, 2023 | ||||||
Assets: | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 56,076 | $ | 99,681 | |||
Marketable securities | 50,784 | 30,467 | |||||
Accounts receivable | 25,500 | 32,371 | |||||
Due from related parties | 693 | 445 | |||||
Inventory, net | 10,322 | 8,777 | |||||
Prepaid expenses and other current assets | 18,792 | 10,598 | |||||
Total current assets | 162,167 | 182,339 | |||||
Operating lease right-of-use assets | 25,624 | 26,900 | |||||
Property and equipment, net | 31,339 | 32,479 | |||||
Intangible assets, net | 165,613 | 172,625 | |||||
Other assets (1) | 4,357 | 4,413 | |||||
Total assets | $ | 389,100 | $ | 418,756 | |||
Liabilities and Stockholders' Equity: | |||||||
Current liabilities: | |||||||
Accounts payable and accrued expenses | $ | 51,959 | $ | 37,456 | |||
Due to related parties | 1,213 | 1,379 | |||||
Short-term lease liabilities | 4,001 | 3,647 | |||||
Other current liabilities | 11,097 | 16,336 | |||||
Total current liabilities | 68,270 | 58,818 | |||||
Long-term debt, net of current portion | 52,160 | 52,688 | |||||
Long-term lease liabilities | 60,800 | 62,938 | |||||
Other liabilities | 12,660 | 14,735 | |||||
Deferred taxes | 1,167 | 1,560 | |||||
Total liabilities | 195,057 | 190,739 | |||||
Stockholders' Equity: | |||||||
Preferred stock | - | - | |||||
Class A common stock | 2 | 2 | |||||
Additional paid-in capital | 1,543,182 | 1,527,778 | |||||
Accumulated deficit | (1,349,600 | ) | (1,300,188 | ) | |||
Accumulated other comprehensive income | 459 | 425 | |||||
Total stockholders' equity | 194,043 | 228,017 | |||||
Total liabilities and stockholders' equity | $ | 389,100 | $ | 418,756 | |||
| (1) | Other assets includes $987 thousand of restricted cash as of both June 30, 2024 and December 31, 2023. |
GeneDx Holdings Corp. Condensed Consolidated Statements of Operations (Unaudited) (in thousands, except share and per share amounts) | |||||||||||||||
June 30, | Six months ended June 30, | ||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||
Revenue | |||||||||||||||
Diagnostic test revenue | $ | 69,439 | $ | 46,635 | $ | 130,543 | $ | 88,485 | |||||||
Other revenue | 1,075 | 2,071 | 2,393 | 3,360 | |||||||||||
Total revenue | 70,514 | 48,706 | 132,936 | 91,845 | |||||||||||
Cost of services | 27,562 | 29,949 | 52,573 | 57,852 | |||||||||||
Gross profit | 42,952 | 18,757 | 80,363 | 33,993 | |||||||||||
Research and development | 10,902 | 17,138 | 22,469 | 31,730 | |||||||||||
Selling and marketing | 16,585 | 15,182 | 32,670 | 28,634 | |||||||||||
General and administrative | 25,170 | 37,341 | 47,615 | 81,030 | |||||||||||
Impairment loss | - | - | - | 2,120 | |||||||||||
Other operating expenses, net | 874 | 718 | 1,848 | 2,465 | |||||||||||
Loss from operations | (10,579 | ) | (51,622 | ) | (24,239 | ) | (111,986 | ) | |||||||
Non-operating income (expenses), net | |||||||||||||||
Change in fair value of warrants and earn-out contingent liabilities | (4,409 | ) | 3,547 | (10,510 | ) | 94 | |||||||||
Interest expense, net | (894 | ) | 1,074 | (1,491 | ) | 1,039 | |||||||||
Other expense, net | (13,481 | ) | 86 | (13,444 | ) | 2,802 | |||||||||
Total non-operating income, net | (18,784 | ) | 4,707 | (25,445 | ) | 3,935 | |||||||||
Loss before income taxes | (29,363 | ) | (46,915 | ) | $ | (49,684 | ) | $ | (108,051 | ) | |||||
Income tax benefit | 190 | 196 | 272 | 343 | |||||||||||
Net loss | $ | (29,173 | ) | $ | (46,719 | ) | $ | (49,412 | ) | $ | (107,708 | ) | |||
Weighted average shares outstanding of Class A common stock | 26,617,955 | 25,418,358 | 26,340,063 | 22,754,948 | |||||||||||
Basic and diluted net loss per share, Class A common stock | $ | (1.10 | ) | $ | (1.84 | ) | $ | (1.88 | ) | $ | (4.73 | ) | |||
GeneDx Holdings Corp. Condensed Consolidated Statements of Cash Flows (Unaudited) (in thousands) | |||||||
Six months ended June 30, | |||||||
2024 | 2023 | ||||||
Operating activities | |||||||
Net loss | $ | (49,412 | ) | $ | (107,708 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation and amortization expense | 10,466 | 18,968 | |||||
Stock-based compensation expense | 2,657 | 156 | |||||
Change in fair value of warrants and contingent liabilities | 10,510 | (94 | ) | ||||
Deferred tax benefit | (272 | ) | (343 | ) | |||
Provision for excess and obsolete inventory | 109 | 2,620 | |||||
Legal reserves | 13,450 | - | |||||
Change in third party payor reserves | 1,066 | (4,308 | ) | ||||
Gain on sale of assets | - | (2,954 | ) | ||||
Gain on debt forgiveness | - | (2,750 | ) | ||||
Impairment loss | - | 2,120 | |||||
Other | 1,738 | 412 | |||||
Change in operating assets and liabilities: | |||||||
Accounts receivable | 6,871 | 10,174 | |||||
Inventory | (1,654 | ) | (486 | ) | |||
Accounts payable and accrued expenses | (10,359 | ) | (25,399 | ) | |||
Other assets and liabilities | (6,088 | ) | 531 | ||||
Net cash used in operating activities | (20,918 | ) | (109,061 | ) | |||
Investing activities | |||||||
Consideration on escrow paid for GeneDx acquisition | - | (12,144 | ) | ||||
Purchases of property and equipment | (1,795 | ) | (2,762 | ) | |||
Proceeds from sales of assets | - | 3,634 | |||||
Purchases of marketable securities | (29,381 | ) | - | ||||
Proceeds from sales of marketable securities | 598 | - | |||||
Proceeds from maturities of marketable securities | 8,720 | - | |||||
Development of internal-use software assets | - | (461 | ) | ||||
Net cash used in investing activities | (21,858 | ) | (11,733 | ) | |||
Financing activities | |||||||
Proceeds from offerings, net of issuance costs | - | 143,002 | |||||
Exercise of stock options | 161 | 266 | |||||
Long-term debt principal payments | - | (2,000 | ) | ||||
Finance lease payoff and principal payments | (990 | ) | (1,222 | ) | |||
Net cash (used in) provided by financing activities | (829 | ) | 140,046 | ||||
Net (decrease) increase in cash, cash equivalents and restricted cash | (43,605 | ) | 19,252 | ||||
Cash, cash equivalents and restricted cash, at beginning of period | 100,668 | 138,303 | |||||
Cash, cash equivalents and restricted cash, at end of period (1) | $ | 57,063 | $ | 157,555 | |||
Supplemental disclosures of cash flow information | |||||||
Cash paid for interest | $ | 4,033 | $ | 946 | |||
Cash paid for taxes | $ | 557 | $ | 1,003 | |||
Stock consideration paid for purchase of business | $ | - | $ | 6,692 | |||
Stock consideration paid pursuant to exercise of Perceptive warrant | $ | 12,586 | $ | - | |||
Purchases of property and equipment in accounts payable and accrued expenses | $ | 501 | $ | 109 | |||
Assets acquired under capital leases obligations | $ | 689 | $ | - | |||
| (1) | Cash, cash equivalents and restricted cash at June 30, 2024 excludes marketable securities of $50.8 million. |
Contacts
Investor Relations Contact:
Investors@GeneDx.com
Media Contact:
Press@GeneDx.com
