Accelerated whole exome and genome test volume growth by 56% year-over-year
Total revenue of $48M in Q2 is inclusive of 36% year-over-year growth of exome and genome test revenue
Expanded gross margins and operating expense rationalization resulting in continued cash burn reduction of 36% year-over-year
Broadened network of strategic partners, including breakthrough research collaboration with PacBio and University of Washington
GeneDx to host conference call today at 4:30 p.m. ET
STAMFORD, Conn., Aug. 08, 2023 (GLOBE NEWSWIRE) -- GeneDx Holdings Corp. (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic and clinical insights, today reported its financial results for the second quarter of 2023.
“Our goal at GeneDx is to end the diagnostic odyssey for patients and their families, and with the growth in exome volume and revenue this quarter, I’m pleased to say that we’re increasingly realizing that mission,” said Katherine Stueland, President and Chief Executive Officer of GeneDx. “We are accelerating physician conversion to whole exome and genome tests, which is not only better for patient care, but also better for the business. We expect this growth to continue through the second half of the year, which gives us confidence to meet our full year revenue guidance. In addition, we are continuing to rationalize our operating expenses and reduce our cash burn as we move forward to gain efficiency.”
Pro Forma Second Quarter Financial Results from Continuing Operations1
Pro forma results for GeneDx reported today include the combination of Legacy GeneDx and only the data and information business of Legacy Sema4, and assume Legacy GeneDx was owned for the entirety of 2022. Continuing operations exclude revenues and costs from the now discontinued Legacy Sema4 diagnostics testing business.
Total Company Second Quarter Financial Results1
Total Company results reported today for the second quarter of 2023 include the combination of continuing operations and the now discontinued Legacy Sema4 diagnostic testing business. All comparable 2022 information presented below excludes any Legacy GeneDx revenues and associated costs prior to the second quarter of 2022 acquisition of GeneDx which closed April 29, 2022.
Recent Business Highlights
Commercial Updates
Scientific Updates
Financial & Corporate Growth
GeneDx Pro Forma Full Year 2023 Guidance
GeneDx is reiterating certain previously issued full year 2023 guidance. The continuing operations of GeneDx, excluding revenues and direct costs from the now discontinued Legacy Sema4 diagnostic testing business, are expected to:
GeneDx is updating its previously issued cash use guidance and now expects to use $70 to $85 million of net cash for the second half of 2023, inclusive of servicing obligations of the previously exited business activities. The Company’s total cash burn in the fourth quarter of 2023 is expected to be nearly half of second quarter burn.
1 The pro forma unadjusted and adjusted results from continuing operations for the second quarter of 2023 and the comparable results for the second quarter of 2022 are presented on a pro forma basis assuming Legacy GeneDx and the Company were combined for the entirety of 2022 and exclude the revenues and costs from the now discontinued Legacy Sema4 diagnostic testing business, and include the combination of the Legacy GeneDx diagnostic business revenues and costs with the data and information revenues and associated costs derived from the Legacy Sema4 business. Actual results include the Legacy GeneDx business from the date of the Company’s acquisition of Legacy GeneDx on April 29, 2022, the purchase accounting associated with the acquisition of Legacy GeneDx, and also include the financial impacts of exited Legacy Sema4 business activities for the full quarter.
2 Adjusted gross margin and adjusted net loss are non-GAAP financial measures. See appendix for a reconciliation of GAAP to Non-GAAP figures presented.
Webcast and Conference Call Details
GeneDx will host a conference call today, August 8, 2023, 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 2023 reported revenue guidance, our expectations regarding our gross margin profile in 2023 and beyond, our use of cash and our cash burn in 2023 and our turning profitable in 2025, our expectations for our growth and future investment in our business, our expectations regarding our plans to pursue new strategic direction, improve our operational efficiency and reduce our cash burn and our ability to scale to profitability, the associated cost savings of our business exits and impact on our gross margins. 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, 2022, filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 16, 2023, 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
GeneDx (Nasdaq: WGS) delivers personalized and actionable health insights to inform diagnosis, direct treatment and improve drug discovery. The company is uniquely positioned to accelerate the use of genomic and large-scale clinical information to enable precision medicine as the standard of care. GeneDx is at the forefront of transforming healthcare through its industry-leading exome and genome testing and interpretation, fueled by one of the world’s largest rare disease data sets. For more information, please visit genedx.com and connect with us on LinkedIn, Facebook, Twitter and Instagram.
Investor Relations Contact:
Tricia Truehart
[email protected]
Media Contact:
Maurissa Messier
[email protected]
Pro forma select volume and revenue from Continuing Operations in the table below assume Legacy GeneDx was owned for the entirety of the applicable quarter(s) and are calculated based on the construct of our continuing operations inclusive of Legacy GeneDx combined with data revenues and associated costs from Legacy Sema4. Pro forma select metrics are presented for illustrative purposes only and are not necessarily indicative of the results that would have occurred had the GeneDx acquisition been completed on such dates or that may occur in the future.
Pro Forma Select Volume & Revenue from Continuing Operations
2Q22 | 3Q22 | 4Q22 | 1Q23 | 2Q23 | |
Volumes | |||||
Whole Exome, Whole Genome | 7,579 | 7,722 | 7,862 | 8,705 | 11,855 |
Exome based Panels | 3,141 | 2,983 | 3,013 | 3,136 | 3,472 |
Hereditary Cancer | 7,391 | 5,445 | 6,069 | 7,120 | 7,142 |
Other individual gene tests and multi-gene disease panels | 27,446 | 28,764 | 31,891 | 33,817 | 32,459 |
Total | 45,557 | 44,914 | 48,835 | 52,778 | 54,928 |
Revenue | |||||
Whole Exome, Whole Genome | $21.1 | $24.0 | $23.3 | $22.4 | $28.7 |
Exome based Panels | $2.4 | $2.3 | $2.0 | $2.0 | $2.0 |
Hereditary Cancer | $3.8 | $3.5 | $4.4 | $4.3 | $3.8 |
Other individual gene tests and multi-gene disease panels | $10.5 | $15.6 | $14.3 | $10.6 | $8.6 |
Data Information | $2.3 | $1.8 | $1.9 | $1.3 | $2.1 |
Total | $40.1 | $47.2 | $45.8 | $40.7 | $45.2 |
Unaudited Pro forma select financial information assume Legacy GeneDx was owned for the entirety of 2022 and is calculated based on the construct of our continuing operations inclusive of Legacy GeneDx combined with data revenues and associated costs from Legacy Sema4. Unaudited Pro forma select financial information is presented for illustrative purposes only and is not necessarily indicative of the results that would have occurred had the Legacy GeneDx acquisition been completed on such dates or that may occur in the future.
UNAUDITED PRO FORMA SELECT FINANCIAL INFORMATION | |||
FOR THE THREE MONTHS ENDED JUNE 30, 2023 | |||
(in thousands) | |||
GeneDx Continuing Operations | Legacy Sema4 Discontinued Business | Combined GeneDx and Sema4 | |
Revenue | $45,226 | $3,480 | $48,706 |
Adjusted Cost of Services | 28,452 | - | 28,452 |
Adjusted Gross Margin | $16,774 | $3,480 | $20,254 |
Adjusted Gross Margin % | 37.1% | -% | 41.6% |
UNAUDITED PRO FORMA SELECT FINANCIAL INFORMATION | |||
FOR THE THREE MONTHS ENDED MARCH 31, 2023 | |||
(in thousands) | |||
GeneDx Continuing Operations | Legacy Sema4 Discontinued Business | Combined GeneDx and Sema4 | |
Revenue | $40,693 | $2,446 | $43,139 |
Adjusted Cost of Services | 26,826 | 2,080 | 28,906 |
Adjusted Gross Margin | $13,867 | $366 | $14,233 |
Adjusted Gross Margin % | 34.1% | 14.9% | 33.0% |
Three months ended June 30, | |||
2023 | 2022 | ||
(in thousands) | |||
Revenue | |||
Diagnostic test revenue | $46,635 | $34,004 | |
Other Revenue | 2,071 | 2,165 | |
Total Revenue | 48,706 | 36,169 | |
Cost of Service | 29,949 | 65,767 | |
Gross (Loss) Profit | $18,757 | $(29,598) | |
Gross Margin | 39% | (82)% | |
Depreciation and amortization | 1,233 | 3,316 | |
Stock-based compensation | 251 | 1,810 | |
Restructuring costs | 13 | 205 | |
Adjusted Gross (Loss) Profit | $20,254 | $(24,267) | |
Adjusted Gross Margin | 42% | (67)% | |
Three months ended March 31, | |
2023 | |
(in thousands) | |
Revenue | |
Diagnostic test revenue | $41,850 |
Other Revenue | 1,289 |
Total Revenue | 43,139 |
Cost of Service | 27,903 |
Gross (Loss) Profit | $15,236 |
Gross Margin | 35.3% |
Depreciation and amortization | 589 |
Stock-based compensation | (1,666) |
Restructuring costs | 74 |
Adjusted Gross (Loss) Profit | $14,233 |
Adjusted Gross Margin | 33.0% |
Three months ended June 30, | |||
2023 | 2022 | ||
(in thousands) | |||
Net (loss) income | $(46,719) | $(85,742) | |
Interest expense, net | (1,074) | 408 | |
Income tax benefit | (196) | (49,077) | |
Depreciation and amortization | 10,332 | 8,964 | |
Stock-based compensation expense | 108 | 22,721 | |
Transaction and acquisition costs | — | 9,099 | |
Restructuring | 1,637 | 6,832 | |
Change in fair market value of financial liabilities | (3,547) | (28,182) | |
Gain on sale of assets | (2,954) | — | |
Third party payor reserve release | (3,238) | — | |
Provision for excess and obsolete inventory associated with Legacy Sema4 | 2,620 | — | |
Other income, net | (86) | (56) | |
Adjusted EBITDA | $(43,117) | $(115,033) | |
Net (loss) income | (46,719) | (85,742) | |
Stock-based compensation expense | 108 | 22,721 | |
Depreciation and amortization | 10,332 | 8,964 | |
Change in fair market value of warrant and earn-out contingent liabilities | (3,547) | (28,182) | |
Transaction and acquisition costs | — | 9,099 | |
Restructuring | 1,637 | 6,832 | |
Gain on sale of assets | (2,954) | — | |
Third party payor reserve release | (3,238) | — | |
Provision for excess and obsolete inventory associated with Legacy Sema4 | 2,620 | — | |
Other income, net | (86) | (56) | |
Adjusted Net loss | $(41,847) | $(66,364) | |
Three months ended March 31, | |
2023 | |
(in thousands) | |
Net (loss) income | $(60,989) |
Interest expense, net | 35 |
Income tax benefit | (147) |
Depreciation and amortization | 8,636 |
Stock-based compensation expense | 48 |
Impairment loss | 2,120 |
Transaction and acquisition costs | — |
Restructuring | 702 |
Change in fair market value of financial liabilities | 3,453 |
Gain on debt forgiveness | (2,750) |
Adjusted EBITDA | $(48,892) |
Net (loss) income | (60,989) |
Stock-based compensation expense | 48 |
Depreciation and amortization | 8,636 |
Impairment loss | 2,120 |
Change in fair market value of warrant and earn-out contingent liabilities | 3,453 |
Transaction and acquisition costs | — |
Restructuring | 702 |
Other, net | (2,750) |
Adjusted Net loss | $(48,780) |
Three months ended, | |||||||||||||||
Q2 2023 | Q1 2023 | Q2 2022 | Q4 2022 | ||||||||||||
(in thousands) | |||||||||||||||
Operating expenses | $70,379 | $75,600 | $133,051 | $308,557 | |||||||||||
Depreciation and amortization | (9,099 | ) | (8,046 | ) | (5,648 | ) | (14,046 | ) | |||||||
Stock-based compensation | 143 | (1,715 | ) | (20,911 | ) | (10 | ) | ||||||||
Restructuring costs | (1,624 | ) | (628 | ) | (15,726 | ) | (7,358 | ) | |||||||
Impairment loss | — | (2,120 | ) | — | (210,145 | ) | |||||||||
Other, net | 334 | — | — | — | |||||||||||
Adjusted operating expenses | $ | 60,133 | $ | 63,091 | $ | 90,766 | $ | 76,998 |
GeneDx Holdings Corp. | |||||||
Condensed Consolidated Balance Sheets | |||||||
(in thousands, except share and per share amounts) | |||||||
June 30, 2023 (unaudited) | December 31, 2022 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 156,655 | $ | 123,933 | |||
Restricted cash | — | 13,470 | |||||
Accounts receivable, net | 32,710 | 42,634 | |||||
Due from related parties | 1,196 | 708 | |||||
Inventory, net | 11,531 | 13,665 | |||||
Prepaid expenses and other current assets | 11,185 | 18,212 | |||||
Total current assets | 213,277 | 212,622 | |||||
Operating lease right-of-use assets | 33,684 | 32,758 | |||||
Property and equipment, net | 43,332 | 51,527 | |||||
Intangible assets, net | 179,638 | 186,650 | |||||
Long-term restricted cash | 900 | 900 | |||||
Other assets | 5,559 | 6,485 | |||||
Total assets | $ | 476,390 | $ | 490,942 | |||
Liabilities and Stockholders’ Equity | |||||||
Current liabilities: | |||||||
Accounts payable and accrued expenses | $ | 54,767 | $ | 84,878 | |||
Due to related parties | 4,338 | 3,593 | |||||
Short-term lease liabilities | 5,346 | 6,121 | |||||
Other current liabilities | 19,917 | 49,705 | |||||
Total current liabilities | 84,368 | 144,297 | |||||
Long-term debt, net of current portion | 6,250 | 6,250 | |||||
Long-term lease liabilities | 63,748 | 60,013 | |||||
Other liabilities | 22,411 | 22,000 | |||||
Deferred taxes | 2,250 | 2,659 | |||||
Warrant liability | 220 | 418 | |||||
Earn-out contingent liability | 1,030 | 1,600 | |||||
Total liabilities | 180,277 | 237,237 | |||||
Commitments and contingencies (Note 10) | |||||||
Stockholders’ equity: | |||||||
Preferred Stock, $0.0001 par value: 1,000,000 and 1,000,000 shares authorized at June 30, 2023 and December 31, 2022, respectively; 0 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively | — | — | |||||
Class A common stock, $0.0001 par value: 1,000,000,000 and 1,000,000,000 shares authorized at June 30, 2023 and December 31, 2022, respectively; 25,761,147 and 11,773,065 shares issued and outstanding at June 30, 2023 and December 31, 2022, respectively | 2 | 1 | |||||
Additional paid-in capital | 1,528,240 | $ | 1,378,125,000 | ||||
Accumulated deficit | (1,232,129 | ) | (1,124,421 | ) | |||
Total stockholders’ equity | 296,113 | 253,705 | |||||
Total liabilities and stockholders’ equity | $ | 476,390 | $ | 490,942 | |||
GeneDx Holdings Corp. | |||||||||||||||
Condensed Consolidated Statements of Operations and Comprehensive Loss | |||||||||||||||
(in thousands, except share and per share amounts) | |||||||||||||||
(unaudited) | |||||||||||||||
Three months ended June 30, | Six months ended June 30, | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Revenue: | |||||||||||||||
Diagnostic test revenue | $ | 46,635 | $ | 34,004 | $ | 88,485 | $ | 86,499 | |||||||
Other revenue | 2,071 | 2,165 | 3,360 | 3,611 | |||||||||||
Total revenue | 48,706 | 36,169 | 91,845 | 90,110 | |||||||||||
Cost of services | 29,949 | 65,767 | 57,852 | 114,083 | |||||||||||
Gross profit (loss) | 18,757 | (29,598 | ) | 33,993 | (23,973 | ) | |||||||||
Research and development | 17,138 | 27,168 | 31,730 | 48,483 | |||||||||||
Selling and marketing | 15,182 | 32,827 | 28,634 | 58,456 | |||||||||||
General and administrative | 37,341 | 71,325 | 81,030 | 118,027 | |||||||||||
Related party expenses | 1,052 | 1,731 | 2,799 | 3,015 | |||||||||||
Impairment loss | — | — | 2,120 | — | |||||||||||
Other, net | (334 | ) | — | (334 | ) | — | |||||||||
Loss from operations | (51,622 | ) | (162,649 | ) | (111,986 | ) | (251,954 | ) | |||||||
Other income (expense), net: | |||||||||||||||
Change in fair market value of warrant and earn-out contingent liabilities | 3,547 | 28,182 | 94 | 41,372 | |||||||||||
Interest income | 1,700 | 382 | 2,432 | 409 | |||||||||||
Interest expense | (626 | ) | (790 | ) | (1,393 | ) | (1,598 | ) | |||||||
Other income, net | 86 | 56 | 2,802 | 56 | |||||||||||
Total other (expense) income, net | 4,707 | 27,830 | 3,935 | 40,239 | |||||||||||
Loss before income taxes | $ | (46,915 | ) | $ | (134,819 | ) | $ | (108,051 | ) | $ | (211,715 | ) | |||
Income tax benefit | 196 | 49,077 | 343 | 49,077 | |||||||||||
Net loss and comprehensive loss | $ | (46,719 | ) | $ | (85,742 | ) | $ | (107,708 | ) | $ | (162,638 | ) | |||
Weighted average shares outstanding of Class A common stock | 25,418,358 | 10,234,910 | 22,754,948 | 8,827,829 | |||||||||||
Basic and diluted net loss per share, Class A common stock | $ | (1.84 | ) | $ | (8.38 | ) | $ | (4.73 | ) | $ | (18.42 | ) | |||
GeneDx Holdings Corp. | |||||||
Condensed Consolidated Statements of Cash Flows | |||||||
(in thousands) | |||||||
(unaudited) | |||||||
Six months ended June 30, | |||||||
2023 | 2022 | ||||||
Operating activities | |||||||
Net loss | $ | (107,708 | ) | $ | (162,638 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation and amortization expense | 18,968 | 14,767 | |||||
Impairment loss | 2,120 | — | |||||
Gain on sale of assets | (2,954 | ) | — | ||||
Stock-based compensation expense | 156 | 40,280 | |||||
Gain on debt forgiveness | (2,750 | ) | — | ||||
Change in fair value of warrant and earn-out contingent liabilities | (94 | ) | (41,372 | ) | |||
Deferred tax benefit | (343 | ) | (49,077 | ) | |||
Provision for excess and obsolete inventory | 2,620 | 347 | |||||
Third party payor reserve release | (4,308 | ) | — | ||||
Non-cash lease expense | 155 | 331 | |||||
Amortization of deferred debt issuance costs | 257 | 257 | |||||
Change in operating assets and liabilities: | |||||||
Accounts receivable | 10,174 | 2,357 | |||||
Inventory | (486 | ) | (2,282 | ) | |||
Prepaid expenses and other current assets | 5,476 | 2,910 | |||||
Due to/from related parties | 256 | (1,325 | ) | ||||
Other assets | 416 | (1,126 | ) | ||||
Accounts payable and accrued expenses | (25,399 | ) | 35,712 | ||||
Contract liabilities | — | (473 | ) | ||||
Other current liabilities | (5,617 | ) | (4,807 | ) | |||
Net cash used in operating activities | (109,061 | ) | (166,139 | ) | |||
Investing activities | |||||||
Consideration on escrow paid for GeneDx acquisition | (12,144 | ) | (127,004 | ) | |||
Purchases of property and equipment | (2,762 | ) | (2,748 | ) | |||
Proceeds from sale of assets | 3,634 | — | |||||
Development of internal-use software assets | (461 | ) | (4,458 | ) | |||
Net cash used in investing activities | (11,733 | ) | (134,210 | ) | |||
Financing activities | |||||||
Proceeds from PIPE issuance, net of issuance costs | — | 197,712 | |||||
Proceeds from offerings, net of issuance costs | 143,002 | — | |||||
Long-term debt principal payment | (2,000 | ) | — | ||||
Finance lease principal payments | (784 | ) | (1,634 | ) | |||
Finance lease payoff | (438 | ) | — | ||||
Exercise of stock options | 266 | 1,819 | |||||
Net cash provided by financing activities | 140,046 | 197,897 | |||||
Net increase (decrease) in cash, cash equivalents and restricted cash | 19,252 | (102,452 | ) | ||||
Cash, cash equivalents and restricted cash, at beginning of period | 138,303 | 401,469 | |||||
Cash, cash equivalents and restricted cash, at end of period | $ | 157,555 | $ | 299,017 |
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