UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934
Date of Report (date of earliest event reported): October 29, 2024
Commission file number 001-39482
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | ||||
| (Address of Principal Executive Offices) (Zip Code) | |||||
Registrant's telephone number, including area code: (888 ) 729-1206
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol | Name of each exchange on which registered | ||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02 Results of Operations and Financial Condition.
On October 29, 2024, GeneDx Holdings Corp. (the “Company”) issued a press release (the “Press Release”) and will hold a conference call announcing the Company's financial results for the quarter ended September 30, 2024. Copies of the Press Release and Earnings Presentation are furnished as Exhibits 99.1 and 99.2, respectively, to this Current Report on Form 8-K.
The information furnished with this Item 2.02, including Exhibits 99.1 and 99.2 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No | Description | ||||
99.1 | |||||
99.2 | |||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| GENEDX HOLDINGS CORP. | |||||||||||
| Date: | October 29, 2024 | By: | /s/ Katherine Stueland | ||||||||
| Name: | Katherine Stueland | ||||||||||
| Title: | Chief Executive Officer | ||||||||||
Exhibit 99.1
GeneDx Reports Third Quarter 2024 Financial Results and Business Highlights
Achieved profitability milestone with third quarter adjusted net income1 of $1.2M
Reported third quarter 2024 revenues2 of $76.6M with 77% year-over-year growth of exome and genome test revenue
Expanded third quarter 2024 adjusted gross margins2 to 64%
Raising guidance to deliver between $284M and $290M in FY 2024 revenue
GeneDx to host conference call today at 8:30 a.m. ET
STAMFORD, Conn., October 29, 2024 — GeneDx Holdings Corp. (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today reported its financial results for the third quarter of 2024.
“We delivered 77% growth on exome and genome revenues in Q3 and have reached the point of profitability, a significant milestone in our company’s history,” said Katherine Stueland, CEO of GeneDx. “Our advancements in genomics are redefining the standard of care, setting new industry standards for clinical utility and economic efficiency, and shortening the time to a diagnosis for thousands of families. With an ever-growing number of families eligible for our services, our growth outlook is healthy and sustainable. We continue to bring life-changing impact to the pediatric outpatient and NICU settings, and we are now establishing the foundation for clinically-actionable, responsible, and scalable genomic newborn screening.”
“Once again, our quarterly performance exceeded our top and bottom-line expectations. The third quarter marked our 10th consecutive quarter of cash flow improvement and we achieved positive adjusted net income ahead of our prior target,” said Kevin Feeley, CFO of GeneDx. “With our industry-leading technology and a massive market opportunity ahead, GeneDx will continue to couple financial discipline with strategic investment to accelerate the business and provide answers for even more families in need.”
Third Quarter 2024 Financial Results (Unaudited)1,2
Revenues
•Revenues from continuing operations grew to $76.6 million, an increase of 52% year-over-year and 11% sequentially.
◦Total company revenues were $76.9 million.
•Exome and genome test revenue grew to $60.0 million, an increase of 77% year-over-year and 18% sequentially.
Exome and genome volume
•Exome and genome test results volume grew to 19,262, an increase of 46% year-over-year and 7% sequentially.
•Exome and genome represented 33% of all test results, up from 23% in the third quarter of 2023 and up from 31% in the second quarter of 2024.
Gross margin
•Adjusted gross margin from continuing operations expanded to 64%, up from 48% in the third quarter of 2023 and up from 62% in the second quarter of 2024.
◦Total company gross margin was 62%.
Operating expenses
•Adjusted total operating expenses were $46.6 million, a decrease of 2% year-over-year and an increase of 4% sequentially.
◦Total GAAP operating expenses were $54.8 million.
Net Income (Loss)
•Adjusted net income improved to $1.2 million, an improvement of 106% year-over-year and 143% sequentially.
◦GAAP net loss was $8.3 million.
Cash burn and cash position
•Total net use of cash was $5.0 million in the third quarter of 2024, an improvement of 88% year-over-year and 17% sequentially.
•Cash, cash equivalents, marketable securities and restricted cash was $117.4 million as of September 30, 2024, inclusive of proceeds of $14.6 million, net of fees, from the issuance of 418,653 shares of Class A common stock in connection with sales pursuant to our “at-the-market” offering during the third quarter of 2024.
GeneDx Full Year 2024 Guidance
GeneDx has updated full year 2024 guidance. Management expects GeneDx to:
•Drive full year 2024 revenues2 between $284 and $290 million (previous guidance was between $255 and $265 million);
•Expand full year 2024 adjusted gross margin2 profile to at least 62% (previous guidance was at least 60%);
•Use between $60 to $65 million of net cash for full year 2024 (previous guidance was between $65 to $70 million)
1.Adjusted gross margin, adjusted total operating expenses and adjusted net income (loss) are non-GAAP financial measures. See appendix for a reconciliation of GAAP to Non-GAAP figures presented.
2.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 are labeled accordingly and include GeneDx’s continuing operations and the financial impacts of exited Legacy Sema4 business activities for the current and all comparative periods.
Third Quarter 2024 Business Highlights
Driving sustainable growth and expanding access for more patient populations
•Achieved over 700,000 clinical exomes and genomes sequenced, with over 100,000 completed in the last six months alone
•Accelerated adoption of whole exome sequencing (WES) and whole genome sequencing (WGS) coverage by state Medicaid programs, bringing total states covering exome or genome sequencing in the pediatric outpatient setting to 30
◦Indiana - WES and WGS (July 2024)
◦Connecticut - WGS (July 2024)
◦Texas - WGS (September 2024)
◦Florida - WGS (October 2024)
•The Centers for Medicare & Medicaid Services issued “historic guidance” to state Medicaid agencies, underscoring their obligation to provide all medically necessary services under the Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) benefit
◦Under EPSDT, every Medicaid-enrolled child under 21 is entitled to services that meet their unique medical needs. This includes diagnostics like exome and genome sequencing - some of the most powerful tools we have to unlock appropriate care, treatments, and crucial support systems for these children.
•Expanded the Epilepsy Partnership Program, a first-of-its-kind patient access program that is increasing access to exome and genome sequencing for pediatric epilepsy patients, by including an additional biopharma partner
•Collaborated with researchers from Wellcome Sanger Institute to release data from the largest and most diverse study to date, with data from more than 30,000 patients, on how recessive genetic changes contribute to developmental disorders in children
◦On September 23, 2024, findings from the study were published in Nature Genetics, showcasing that most new recessive developmental disorder diagnoses lie within known genes.
◦The publication is further evidence of our commitment to the important role of diversity in genomics and belief that serving a more diverse patient population drives more definitive diagnoses for patients of all backgrounds.
Demonstrating genome leadership in the neonatal inventive care unit (NICU)
•Launched improvements to our rapid whole genome sequencing product, including cheek swabs for more accessible sample collection, and shortened turnaround times to as soon as five days
•Progressed initiative to launch Epic Aura in the first half of 2025, which will seamlessly integrate GeneDx exome and genome testing into the ordering and resulting workflows of many of the largest health systems across the country
Leaders in genomic newborn screening (gNBS)
•Conducted more gNBS than any other lab in the United States and successfully executed multi-site implementation strategies across diverse patient populations, positioning GeneDx as the clear leader set to revolutionize the standard approach to NBS
◦On October 8, 2024, data was presented at the International Conference on Newborn Sequencing (ICoNS) showcasing that GeneDx has now provided genomic newborn screenings for more than 14,000 infants through its participation in the groundbreaking GUARDIAN and Early Check research studies. Today, that number exceeds 15,000.
•Revealed limitations of traditional newborn screening methods and showcased the promise of advanced genomic technology to deliver equitable health care for all children
◦On October 24, 2024, findings from the GUARDIAN study were published in JAMA (Journal of the American Medical Association), a leading peer-reviewed medical journal.
◦GUARDIAN goes beyond the typical newborn screening panel of about 60 conditions to now over 450-early onset genetic conditions with established effective interventions.
◦Over the initial 11-month period, 4,000 newborns were enrolled and 3.7% of newborns had positive screenings.
◦By referencing our internal database, one of the largest of its kind enriched for rare disease, we find that the average age of diagnosis for children with these same conditions ranges from 7-11 years.
◦Of the newborns with true positive findings, 92% had a confirmed diagnosis for a condition not included in traditional NBS.
◦The study highlights the wide acceptance of more advanced and modernized NBS, with 72% of families approached for the study consenting to participate.
Webcast and Conference Call Details
GeneDx will host a conference call today, October 29, 2024, at 8:30 a.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, and our use of net cash in 2024. 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.
Investor Relations Contact:
Investors@GeneDx.com
Media Contact:
Press@GeneDx.com
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
| 3Q24 | 2Q24 | 1Q24 | 4Q23 | 3Q23 | |||||||||||||||||||||||||
| Volumes | |||||||||||||||||||||||||||||
| Whole exome, whole genome | 19,262 | 18,017 | 16,592 | 15,663 | 13,216 | ||||||||||||||||||||||||
| Hereditary cancer | 4,672 | 5,482 | 6,868 | 8,240 | 8,556 | ||||||||||||||||||||||||
| Other panels | 35,095 | 34,204 | 31,763 | 33,692 | 35,861 | ||||||||||||||||||||||||
| Total | 59,029 | 57,703 | 55,223 | 57,595 | 57,633 | ||||||||||||||||||||||||
| Revenue ($ millions) | |||||||||||||||||||||||||||||
| Whole exome, whole genome | $ | 60.0 | $ | 50.7 | $ | 44.0 | $ | 39.2 | $ | 34.0 | |||||||||||||||||||
| Hereditary cancer | 3.3 | 3.8 | 5.5 | 5.5 | 4.5 | ||||||||||||||||||||||||
| Other panels | 13.8 | 13.3 | 10.7 | 11.2 | 10.6 | ||||||||||||||||||||||||
| Data information | (0.5) | 1.1 | 1.3 | 2.2 | 1.3 | ||||||||||||||||||||||||
| Total | $ | 76.6 | $ | 68.9 | $ | 61.5 | $ | 58.1 | $ | 50.4 | |||||||||||||||||||
Unaudited Select Financial Information (in thousands)
| Three months ended September 30, 2024 | Three months ended June 30, 2024 | ||||||||||||||||||||||||||||||||||
| GeneDx | Legacy Sema4 | Total | GeneDx | Legacy Sema4 | Total | ||||||||||||||||||||||||||||||
| Revenue | $76,622 | $252 | $76,874 | $68,924 | $1,590 | $70,514 | |||||||||||||||||||||||||||||
| Adjusted cost of services | 27,370 | — | 27,370 | 26,523 | 145 | 26,668 | |||||||||||||||||||||||||||||
| Adjusted gross profit | $49,252 | $252 | $49,504 | $42,401 | $1,445 | $43,846 | |||||||||||||||||||||||||||||
| Adjusted gross margin % | 64.3% | 100.0% | 64.4% | 61.5% | 90.9% | 62.2% | |||||||||||||||||||||||||||||
| Three months ended September 30, 2023 | |||||||||||||||||
| GeneDx | Legacy Sema4 | Total | |||||||||||||||
| Revenue | $50,350 | $2,953 | $53,303 | ||||||||||||||
| Adjusted cost of services | 26,079 | 225 | 26,304 | ||||||||||||||
| Adjusted gross profit | $24,271 | $2,728 | $26,999 | ||||||||||||||
| Adjusted gross margin % | 48.2% | 92.4% | 50.7% | ||||||||||||||
| Three months ended September 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 | $ | 77,418 | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | 77,418 | |||||||||||||||||||||||||||||||
| Other revenue | (544) | — | — | — | — | — | — | (544) | |||||||||||||||||||||||||||||||||||||||
| Total revenue | 76,874 | — | — | — | — | — | — | 76,874 | |||||||||||||||||||||||||||||||||||||||
| Cost of services | 29,045 | (1,495) | (174) | (6) | — | — | — | 27,370 | |||||||||||||||||||||||||||||||||||||||
| Gross profit | 47,829 | 1,495 | 174 | 6 | — | — | — | 49,504 | |||||||||||||||||||||||||||||||||||||||
| Gross margin | 62.2 | % | 64.4 | % | |||||||||||||||||||||||||||||||||||||||||||
| Research and development | 11,665 | (222) | (537) | — | — | — | — | 10,906 | |||||||||||||||||||||||||||||||||||||||
| Selling and marketing | 17,025 | (1,225) | (394) | (55) | — | — | — | 15,351 | |||||||||||||||||||||||||||||||||||||||
| General and administrative | 26,145 | (2,987) | (2,531) | (308) | — | — | — | 20,319 | |||||||||||||||||||||||||||||||||||||||
| Impairment loss | — | — | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
| Other, net | 774 | — | — | — | — | — | — | 774 | |||||||||||||||||||||||||||||||||||||||
| Loss from operations | (7,780) | 5,929 | 3,636 | 369 | — | — | — | 2,154 | |||||||||||||||||||||||||||||||||||||||
| Interest income (expense), net | (843) | — | — | — | — | — | — | (843) | |||||||||||||||||||||||||||||||||||||||
| Other income (expense), net | 264 | — | — | — | 880 | — | (1,327) | (183) | |||||||||||||||||||||||||||||||||||||||
| Income tax benefit | 47 | — | — | — | — | — | — | 47 | |||||||||||||||||||||||||||||||||||||||
| Net income (loss) | $ | (8,312) | $ | 5,929 | $ | 3,636 | $ | 369 | $ | 880 | $ | — | $ | (1,327) | $ | 1,175 | |||||||||||||||||||||||||||||||
| Three months ended September 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 | $ | 51,955 | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | 51,955 | |||||||||||||||||||||||||||||||
| Other revenue | 1,348 | — | — | — | — | — | — | 1,348 | |||||||||||||||||||||||||||||||||||||||
| Total revenue | 53,303 | — | — | — | — | — | — | 53,303 | |||||||||||||||||||||||||||||||||||||||
| Cost of services | 28,044 | (1,613) | (75) | (52) | — | — | — | 26,304 | |||||||||||||||||||||||||||||||||||||||
| Gross profit | 25,259 | 1,613 | 75 | 52 | — | — | — | 26,999 | |||||||||||||||||||||||||||||||||||||||
| Gross margin | 47.4 | % | 50.7 | % | |||||||||||||||||||||||||||||||||||||||||||
| Research and development | 14,288 | (283) | 533 | (970) | — | — | — | 13,568 | |||||||||||||||||||||||||||||||||||||||
| Selling and marketing | 16,763 | (1,225) | 115 | (415) | — | — | — | 15,238 | |||||||||||||||||||||||||||||||||||||||
| General and administrative | 26,099 | (5,551) | (1,004) | (754) | — | — | — | 18,790 | |||||||||||||||||||||||||||||||||||||||
| Impairment loss | 8,282 | — | — | — | — | (8,282) | — | — | |||||||||||||||||||||||||||||||||||||||
| Other, net | 2,794 | — | — | — | — | (1,014) | — | 1,780 | |||||||||||||||||||||||||||||||||||||||
| Loss from operations | (42,967) | 8,672 | 431 | 2,191 | — | 9,296 | — | (22,377) | |||||||||||||||||||||||||||||||||||||||
| Interest income (expense), net | 1,053 | — | — | — | — | — | — | 1,053 | |||||||||||||||||||||||||||||||||||||||
| Other income (expense), net | (544) | — | — | — | (590) | — | 1,134 | — | |||||||||||||||||||||||||||||||||||||||
| Income tax benefit | 172 | — | — | — | — | — | — | 172 | |||||||||||||||||||||||||||||||||||||||
| Net loss | $ | (42,286) | $ | 8,672 | $ | 431 | $ | 2,191 | $ | (590) | $ | 9,296 | $ | 1,134 | $ | (21,152) | |||||||||||||||||||||||||||||||
| 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 | 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) | |||||||||||||||||||||||||||||||
GeneDx Holdings Corp.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
| September 30, 2024 (Unaudited) | December 31, 2023 | ||||||||||
| Assets: | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 57,894 | $ | 99,681 | |||||||
| Marketable securities | 58,566 | 30,467 | |||||||||
| Accounts receivable | 38,220 | 32,371 | |||||||||
| Due from related parties | 260 | 445 | |||||||||
| Inventory, net | 10,770 | 8,777 | |||||||||
| Prepaid expenses and other current assets | 20,300 | 10,598 | |||||||||
| Total current assets | 186,010 | 182,339 | |||||||||
| Operating lease right-of-use assets | 24,936 | 26,900 | |||||||||
| Property and equipment, net | 31,452 | 32,479 | |||||||||
| Intangible assets, net | 162,106 | 172,625 | |||||||||
Other assets (1) | 4,336 | 4,413 | |||||||||
| Total assets | $ | 408,840 | $ | 418,756 | |||||||
| Liabilities and Stockholders’ Equity: | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable and accrued expenses | $ | 56,416 | $ | 37,456 | |||||||
| Due to related parties | 727 | 1,379 | |||||||||
| Short-term lease liabilities | 3,698 | 3,647 | |||||||||
| Other current liabilities | 16,501 | 16,336 | |||||||||
| Total current liabilities | 77,342 | 58,818 | |||||||||
| Long-term debt, net of current portion | 52,034 | 52,688 | |||||||||
| Long-term lease liabilities | 60,369 | 62,938 | |||||||||
| Other liabilities | 13,540 | 14,735 | |||||||||
| Deferred taxes | 1,054 | 1,560 | |||||||||
| Total liabilities | 204,339 | 190,739 | |||||||||
| Stockholders’ Equity: | |||||||||||
| Preferred stock | — | — | |||||||||
| Class A common stock | 2 | 2 | |||||||||
| Additional paid-in capital | 1,561,493 | 1,527,778 | |||||||||
| Accumulated deficit | (1,357,912) | (1,300,188) | |||||||||
| Accumulated other comprehensive income | 918 | 425 | |||||||||
| Total stockholders’ equity | 204,501 | 228,017 | |||||||||
| Total liabilities and stockholders’ equity | $ | 408,840 | $ | 418,756 | |||||||
(1)Other assets includes $987 thousand of restricted cash as of both September 30, 2024 and December 31, 2023.
GeneDx Holdings Corp.
Condensed Consolidated Statements of Operations (Unaudited)
(in thousands, except share and per share amounts)
| Three months ended September 30, | Nine months ended September 30, | ||||||||||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||||||||||
| Revenue | |||||||||||||||||||||||
| Diagnostic test revenue | $ | 77,418 | $ | 51,955 | $ | 207,961 | $ | 140,440 | |||||||||||||||
| Other revenue | (544) | 1,348 | 1,849 | 4,708 | |||||||||||||||||||
| Total revenue | 76,874 | 53,303 | 209,810 | 145,148 | |||||||||||||||||||
| Cost of services | 29,045 | 28,044 | 81,618 | 85,896 | |||||||||||||||||||
| Gross profit | 47,829 | 25,259 | 128,192 | 59,252 | |||||||||||||||||||
| Research and development | 11,665 | 14,288 | 34,134 | 46,018 | |||||||||||||||||||
| Selling and marketing | 17,025 | 16,763 | 49,695 | 45,397 | |||||||||||||||||||
| General and administrative | 26,145 | 26,099 | 73,760 | 107,129 | |||||||||||||||||||
| Impairment loss | — | 8,282 | — | 10,402 | |||||||||||||||||||
| Other operating expenses, net | 774 | 2,794 | 2,622 | 5,259 | |||||||||||||||||||
| Loss from operations | (7,780) | (42,967) | (32,019) | (154,953) | |||||||||||||||||||
| Non-operating income (expenses), net | |||||||||||||||||||||||
| Change in fair value of warrants and earn-out contingent liabilities | (880) | 590 | (11,390) | 684 | |||||||||||||||||||
| Interest (expense) income, net | (843) | 1,053 | (2,334) | 2,092 | |||||||||||||||||||
| Other income (expense), net | 1,144 | (1,134) | (12,300) | 1,668 | |||||||||||||||||||
| Total non-operating income (expense), net | (579) | 509 | (26,024) | 4,444 | |||||||||||||||||||
| Loss before income taxes | (8,359) | (42,458) | $ | (58,043) | $ | (150,509) | |||||||||||||||||
| Income tax benefit | 47 | 172 | 319 | 515 | |||||||||||||||||||
| Net loss | $ | (8,312) | $ | (42,286) | $ | (57,724) | $ | (149,994) | |||||||||||||||
| Weighted average shares outstanding of Class A common stock | 27,095,986 | 25,788,747 | 26,593,877 | 23,777,327 | |||||||||||||||||||
| Basic and diluted net loss per share, Class A common stock | $ | (0.31) | $ | (1.64) | $ | (2.17) | $ | (6.31) | |||||||||||||||
GeneDx Holdings Corp.
Condensed Consolidated Statements of Cash Flows (Unaudited)
(in thousands)
| Nine months ended September 30, | |||||||||||
| 2024 | 2023 | ||||||||||
| Operating activities | |||||||||||
| Net loss | $ | (57,724) | $ | (149,994) | |||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
| Depreciation and amortization expense | 16,395 | 27,640 | |||||||||
| Stock-based compensation expense | 6,293 | 586 | |||||||||
| Change in fair value of warrants and contingent liabilities | 11,390 | (684) | |||||||||
| Deferred tax benefit | (319) | (515) | |||||||||
| Provision for excess and obsolete inventory | 137 | 3,634 | |||||||||
| Legal reserves | 12,123 | — | |||||||||
| Change in third party payor reserves | 737 | (6,848) | |||||||||
| Gain on sale of assets | — | (2,954) | |||||||||
| Gain on debt forgiveness | — | (2,750) | |||||||||
| Impairment loss | — | 10,402 | |||||||||
| Other | 2,639 | 1,071 | |||||||||
| Change in operating assets and liabilities: | |||||||||||
| Accounts receivable | (5,850) | 10,726 | |||||||||
| Inventory | (2,131) | 682 | |||||||||
| Accounts payable and accrued expenses | (7,807) | (39,913) | |||||||||
| Other assets and liabilities | (1,196) | (1,372) | |||||||||
| Net cash used in operating activities | (25,313) | (150,289) | |||||||||
| Investing activities | |||||||||||
| Consideration on escrow paid for Legacy GeneDx acquisition | — | (12,144) | |||||||||
| Purchases of property and equipment | (2,441) | (2,874) | |||||||||
| Proceeds from sales of assets | — | 3,887 | |||||||||
| Purchases of marketable securities | (52,725) | (43,935) | |||||||||
| Proceeds from sales of marketable securities | 598 | — | |||||||||
| Proceeds from maturities of marketable securities | 24,955 | 16,665 | |||||||||
| Development of internal-use software assets | — | (461) | |||||||||
| Net cash used in investing activities | (29,613) | (38,862) | |||||||||
| Financing activities | |||||||||||
| Proceeds from offerings, net of issuance costs | 14,589 | 143,002 | |||||||||
| Exercise of stock options | 247 | 266 | |||||||||
| Long-term debt principal payments | (198) | (2,000) | |||||||||
| Finance lease payoff and principal payments | (1,499) | (2,133) | |||||||||
| Net cash provided by financing activities | 13,139 | 139,135 | |||||||||
| Net decrease in cash, cash equivalents and restricted cash | (41,787) | (50,016) | |||||||||
| 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) | $ | 58,881 | $ | 88,287 | |||||||
| Supplemental disclosures of cash flow information | |||||||||||
| Cash paid for interest | $ | 6,068 | $ | 1,116 | |||||||
| Cash paid for taxes | $ | 910 | $ | 1,178 | |||||||
| 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 | $ | 2,612 | $ | 1,220 | |||||||
| Assets acquired under capital leases obligations | $ | 689 | $ | — | |||||||
(1)Cash, cash equivalents and restricted cash at September 30, 2024 excludes marketable securities of $58.6 million.
One test. Big picture. Brighter futures. October 29, 2024 GeneDx (Nasdaq: WGS) 3Q 2024 Earnings Presentation Exhibit 99.2
2 Disclaimer This presentation contains forward-looking statements under the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that do not relate to historical facts and events and such statements and opinions pertaining to the future that, for example, contain wording such as “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward- looking statements contained in this presentation may include, but are not limited to, statements about: our future performance and our market opportunity, our expectations regarding full year 2024 revenue, adjusted gross margin profile and cash burn in 2024. We cannot assure that the forward-looking statements in this presentation will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The forward-looking statements and opinions contained in this presentation are based on our management’s beliefs and assumptions and are based upon information currently available to our management as of the date of this presentation and, while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. Many factors could cause actual future events to differ materially from the forward-looking statements in this presentation, including but not limited to: (i) the 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 information, opinions and forward-looking statements contained in this announcement speak only as of its date and are subject to change without notice. This presentation contains estimates, projections and other information concerning our industry, our business, and the markets for our products and services. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties, and actual events or circumstances may differ materially from events and circumstances that are assumed in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from our own internal estimates and research as well as from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources. While we believe our internal company research as to such matters is reliable and the market definitions are appropriate, neither such research nor these definitions have been verified by any independent source. We discuss these and other risks and uncertainties in greater detail in the sections entitled “Risk Factors” and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our periodic reports and other filings we make with the SEC from time to time. Given these uncertainties, you should not place undue reliance on the forward-looking statements. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason after the date of this presentation to conform these statements to actual results or to changes in our expectations. We file reports, proxy statements, and other information with the SEC. Such reports, proxy statements, and other information concerning us are available www.sec.gov. Requests for copies of such documents should be directed to our Investor Relations department at GeneDx Holdings Corp. 333 Ludlow Street, North Tower 6th Floor, Stamford, Connecticut, 06902. Our telephone number is 888-729-1206.
WGS Q3 2024 Results Third quarter 2024 revenue from continuing operations1 of $76.6M with 77% year-over- year revenue growth for exome and genome test revenue Achieved profitability milestone with third quarter adjusted net income1,2 of $1.2M Expanded third quarter 2024 adjusted gross margin1,2 to 64% Third quarter 2024 total cash burn of $5M; ending September 30, 2024 with cash, cash equivalents, marketable securities and restricted cash of $117.4M 1. Results from continuing operations, which representatives 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. 2. Adjusted gross margin and adjusted net income are non-GAAP financial measure. For a reconciliation of GAAP and non-GAAP results, please refer to the reconciliation contained at the end of this earnings presentation. 3
4 77% Revenue – strong growth driven by high value whole exome and genome Revenue1 Q3 2024 Revenue from continuing operations $76.6M Growth year-over-year 52% Growth sequentially 11% Exome and genome test revenue $60.0M Growth year-over-year 77% Growth sequentially 18% Increase in 3Q24 exome/genome test result volume year-over-year; +7% sequentially 1. Total company revenues were $76.9M for the third quarter 2024. Results from continuing operations exclude the results of the exited Legacy Sema4 diagnostic testing business. Total company results include GeneDx's continuing operations and the financial impacts of exited Legacy Sema4 business activities. 46% Increase in 3Q24 exome/genome revenue year-over-year; +18% sequentially
5 Gross profit – expansion driven by mix shift, cost per test reductions and improved reimbursement Exome/genome can be the best test for patients. They are also best for our business. 33% Exome/genome test result volume Adjusted gross margins1 from continuing operations in 3Q24, up from 48% in 3Q23 and 62% in 2Q24 64% 1. Total company gross profit was $47.8M for the third quarter of 2024, and total company gross margin was 62%. Adjusted gross profit from continuing operations and adjusted gross margin for continuing operations exclude the results of the exited Legacy Sema4 diagnostic testing business as well as depreciation, amortization and stock-based compensation. Total company gross profit and company gross margin include GeneDx’s continuing operations and the financial impacts of exited Legacy Sema4 business activities. 2. Adjusted gross profit and adjusted gross margin are non-GAAP financial measures. For a reconciliation of GAAP and non-GAAP results, please refer to the reconciliation contained at the end of this earnings presentation. Gross Profit1 3Q24 QoQ Sequential YoY Adj. Gross Profit2 $49.3M 16% 103% Adj. Gross Margin %2 64% +276bps +1,607bps
6 Cash – balance sheet bolstered to execute growth strategy 1 $117M Cash, cash equivalents, marketable securities and restricted cash on hand at September 30, 2024 10 Consecutive quarters of cash burn reduction since acquiring GeneDx Net use of cash for the total company in Q3 Improvement in total company net cash burn rate year-over-year; improved 17% sequentially $5M 88%
2024 Guidance Update Drive full year 2024 revenues1 between $284 to $290 million (previous guidance was between $255 to $265 million) Expand full year 2024 adjusted gross margin2 profile to at least 62% (previous guidance was at least 60%) Use between $60 to $65 million of net cash for full year 2024 (previous guidance was between $65 to $70 million) 7 1. Revenue from continuing operations, which representatives our ongoing business strategy, exclude any revenue 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. 2. Adjusted gross profit is a non-GAAP financial measures. For a reconciliation of GAAP and non-GAAP results, please refer to the reconciliation contained at the end of this earnings presentation.
8 Appendix
GeneDx is a leader in improving health outcomes through genomic insights.
10 We address the costly and prolonged path to diagnosis Years of avoidable expenses and still no diagnosis A diagnosis after a long and expensive journey A fast and cost-effective diagnosis 1. Pre-exome standard of care 2. Exome as last resort 3. Exome-first model The diagnostic odyssey: Endless specialist visits, ongoing mismanagement of undiagnosed disease, and expensive, ineffective and often invasive diagnostic testing Undiagnosed, sick child Outcomes Exome Exome
Exome sequencing can break the cycle of misdiagnosis and uncertainty $6,800 savings per diagnosis2† $30,000 per case average savings1* Rapid results ✓ Patient retention ✓ Patients connected ✓ Healthier patients ✓ Tests ordered Starting with the most vulnerable patients References: 1. ScienceDaily. (2017, October 19). Rapid whole-genome sequencing of neonatal ICU patients is useful and cost-effective. ScienceDaily. 2. Tan TY, Dillon OJ, Stark Z, et al. Diagnostic Impact and Cost-effectiveness of Whole-Exome Sequencing for Ambulant Children With Suspected Monogenic Conditions. JAMA Pediatrics. 2017;171(9):855. doi:10.1001/jamapediatrics.2017.1755 *In the NICU from reduced length of stay, unnecessary care (inpatient). †When tested at first tertiary presentation for Pediatric Delay Disorder (outpatient). 11 Patient Expedited Diagnoses Improved Outcomes Reduced Costs
12 Exome sequencing is a cost-effective solution to avoid the diagnostic odyssey A look at the average diagnostic odyssey 1. Genetic Alliance UK. The Rare Reality 2016. Retrieved from: https://geneticalliance.org.uk/wp-content/uploads/2024/02/the-rare-reality-an-insight-into-the-patient-and-family-experience-of-rare-disease.pdf. on June 4, 2024 2. Global Genes. RARE Disease Facts. Retrieved from: www.globalgenes.org/rare-disease-facts/ on June 4, 2024 3. Soden SE, Saunders CJ, et al. Effectiveness of exome and genome sequencing guided by acuity of illness for diagnosis of neurodevelopmental disorders. Sci Transl Med. 2014 Dec 3;6(265):265ra168. doi: 10.1126/scitranslmed.3010076. 4. Fung JLF, Yu MHC, et al. A three-year follow-up study evaluating clinical uti lity of exome sequencing and diagnostic potential of reanalysis. NPJ Genom Med. 2020 Sep 10;5(1):37. doi: 10.1038/s41525-020-00144-x. PMID: 32963807 misdiagnoses1 uninformative tests3 years to an accurate diagnosis26+ in additional healthcare costs3>$10k have a change in management with a genetic diagnosis4>70% 53
13 GeneDx offers leading exome and genome products • Genome sequencing – Analyzes the entirety of an individual’s DNA, which is known as the genome. The genome includes ~20,000 genes. • Exome sequencing – Analyzes the protein coding regions of the ~20,000 genes in an individual’s genome, which is known as the exome. The exome is thought to contain a majority of disease-causing genetic variants. Translating complex genomic data into definitive diagnoses for patients
Changing the perception of exome and genome sequencing GeneDx has spent over a decade solving for limitations of the past and differentiating our products Then GeneDx Now “I can get results in days to weeks”“These tests take months to get results” “These tests are wildly expensive” “Tests are affordable and widely covered” “Results are confusing and filled with useless information” “My patient can get a definitive diagnosis” Turnaround time Cost Interpretation 14
15 Patients we serve today are difficult to diagnose and have complex needs o Congenital abnormalities (birth defects) o Significant Intellectual disability o Global developmental delay o Seizures/epilepsy o Failure to thrive or other growth concerns o Autism spectrum disorder o Complex neurodevelopmental disorder o Severe neuropsychiatric condition o Cerebral palsy o Dysmorphic features o Significant hearing or visual impairment o Period of unexplained developmental regression o Biochemical findings suggesting inborn error of metabolism o Family history strongly suggestive of a genetic etiology Patients typically have 2+ of the indications below
16 1. Savatt JM et al. Front Pediatr. 2021;9:526779. 2. Srivastava S et al. Genet Med. 2019;21(11):2413–2421. 3. Pekeles H et al. Pediatr Neurol. 2019;92:32-36. 4. Stefanski A et al. Epilepsia. 2021;62(1):143-151. 5. Mellone S et al. Front Genet. 2022;13:875182. 6. Spataro N et al. Genes (Basel). 2023;14(3):708. 7. Sheidley BR et al. Epilepsia. 2022;63(2):375-387. 8. Ní Ghrálaigh F et al. J Autism Dev Disord. 2023;53(1):484-488. 9. Arteche-López A et al. Genes. 2021(12):560. Exome sequencing offers greater diagnostic yields vs. other technologies
GeneDx is positioned to enable a data-informed future for healthcare.
Adults: $16B Expanding into adult markets to replace multi-gene panel and individual gene tests New market expansion enables us to serve more patients Rapidly growing patient opportunity and substantial cost savings via early screening Rare Disease & Pediatrics: $3B *Company Estimates supported by DefinitiveHC diagnosis data. Conservatively, our total addressable market is ~$30 billion.* Newborn Screening: $10B Currently participating in studies to evaluate exome and genome sequencing at birth 18 GeneDx is starting with a focus on rare disease and pediatrics and then expanding into larger markets
We're focused on the Rare Disease & Pediatrics market today Rapidly growing patient opportunity and substantial cost savings via early screening Rare Disease & Pediatrics: $3B 19 Inpatient ~1/3 of TAM Outpatient ~2/3 of TAM Target Clinicians: o Geneticists o Pediatric Neurologists o Developmental Pediatricians o Pediatricians (long-term) Products: o Primarily exome and growing genome Primary Clinical Indications: o Epilepsy o Intellectual disability o Developmental delay Target Clinicians: o Geneticists o Neonatologists Products: o Primarily rapid whole genome sequencing Primary Clinical Indications: o Unexplained critical illness o Congenital anomalies Inpatient Outpatient *Company estimates supported by Definitive HC diagnosis data.
Confidential & Proprietary. Do Not Distribute. 20 Payor coverage for exome and genome sequencing is expanding Data through October 2024. 〉 GeneDx is contracted with over 80% of covered lives, including all large national commercial payers 〉Medicaid and commercial insurance coverage continues to grow for exome and genome o 30 states cover exome or genome sequencing • In Q3, Indiana, Texas, Connecticut, and Florida added or enhanced coverage for exome and/or genome sequencing o 14 states cover rapid genome sequencing o Biomarker bills are driving momentum in Medicaid coverage for exome and genome testing Medicaid Programs Covering Genetic Testing by Year 2015: First state Medicaid covers Exome 2021: First state Medicaid covers Rapid Testing 30 25 20 15 10 5 0 0 3 1 30 2015 2021 2024 Year Rapid Testing Exome or Genome Sequencing 22 14
21 Medicaid programs across the country are expanding access Whole Exome or Whole Genome Sequencing Rapid Genome Sequencing Both No Coverage Current Medicaid Coverage Landscape Data through October 2024. New or Enhanced Coverage
Medical practice guidelines recommend exome and genome sequencing for patients ACMG Practice Guideline1: “Strong recommendation based on the available evidence to support the use of ES/GS as either a first- (or second-) line test in patients …. ES/ GS demonstrates clinical utility for the patients and their families with limited evidence for negative outcomes and the ever-increasing emerging evidence of therapeutic benefit.” NSGC Guideline2: “Recommending Exome Sequencing as a First-Tier Genetic Test for Unexplained Epilepsies” 22 American Epilepsy Society: “Exome or genome sequencing are favored for most scenarios, as they are more likely to provide a diagnosis.” 1. Manickam K, McClain MR, Demmer LA, et al. Exome and genome sequencing for pediatric patients with congenital anomalies or intellectual disability: an evidence-based clinical guideline of the American College of Medical Genetics and Genomics (ACMG). Genet Med. 2021 Nov;23(11):2029-2037. doi: 10.1038/s41436-021-01242-6. Epub 2021 Jul 1. 2. Smith L, Malinowski J, Ceulemans S, et al. Genetic testing and counseling for the unexplained epilepsies: An evidence-based practice guideline of the National Society of Genetic Counselors. J Genet Couns. 2022 Oct 24. doi.org/10.1002/jgc4.1646
23 Pay-it-forward data strategy For every patient that we test, our underlying interpretation platform gets smarter, and we can offer more answers to more patients. The impact scales as we capture more and more of the market. Additional patients tested mproved interpretation platform ore underlying data ore answ ers for patients providers igher diagnostic y ield f ewer S Additional patients tested mproved interpretation platform ore underlying data ore answ ers for patients providers igher diagnostic yield fewer S
24 >700K sequenced exomes Data is at the center of our business Our huge dataset and intelligent interpretation platform set us apart and fuel innovation Simplifies complex genomic data Reduces variants of unknown significance Increases diagnostic yield Significant clinical and genomic data Fuels improved testing accuracy Advances science and powering future discoveries Advanced interpretation platform
25 Butler L. et al. Exome-based testing for patients with seizures: Advantages over panel-based testing. Poster presented at American Epilepsy Society Annual Meeting; December 2, 2023; Orlando, FL. Only 43% are tested on many commercial epilepsy panels Common diseases are in fact a constellation of genetic diagnoses One example is epilepsy. At least 768 different genes are related to seizures.
26 Butler L. et al. Exome-based testing for patients with seizures: Advantages over panel-based testing. Poster presented at American Epilepsy Society Annual Meeting; December 2, 2023; Orlando, FL. Exome sequencing checks all 768 genes Only 43% are tested on many commercial epilepsy panels Common diseases are in fact a constellation of genetic diagnoses One example is epilepsy. At least 768 different genes are related to seizures.
Confidential & Proprietary. Do Not Distribute. 27 We are translating our leadership in exome and investing in a genome future We've improved solutions for our providers to deliver the best patient care Integrating with Epic Aura (2025) Expanding access by integrating into existing health system and provider workflows Improving WGS products Adding repeat expansions to increase diagnostic yield and decrease the need for follow-up testing Reducing rWGS turnaround time Written results in as soon as 5 days Expanding sample collection options Improving WGS accessibility with cheek swabs Epic and Aura are trademarks of Epic Systems Corporation
28 1 in 3 babies in the NICU is likely to have a genetic condition that could be diagnosed with rWGS1 Cost associated with NICU/PICU care for these babies with genetic disease is over 50% of the US pediatric inpatient health spend2,3 63% of infants had abnormal rapid WGS results, and 88% of these cases resulted in a change in management We are demonstrating the clinical and economic utility of rWGS through the SeqFirst study. In phase one of the SeqFirst study: 90% of diagnoses made by WGS would not have been predicted by clinical features 1. NICUSeq Study Group, Krantz ID, Medne L, et al. Effect of whole-genome sequencing on the clinical management of acutely ill infants with suspected genetic disease: a randomized clinical tr ial. JAMA Pediatr. 2021 Dec 1;175(12):1218-1226. doi: 10.1001/jamapediatrics.2021.3496 2. Dukhovny D and Zupanci JAF. Economic Evaluation With Clinica l Trials in Neonato logy. Neoreviews (2011) 12 (2): e69–e75 https://doi.org/10.1542/neo.12-2-e69 3. Gonzaludo N, Belmont JW, Gainullin VG, et a l. Estimating the burden and economic impact of pediatric genetic disease. Genet Med. 2019 Aug;21(8):1781-1789. doi: 10.1038/s41436-018-0398-5
Today, we shorten the diagnostic journey. Tomorrow, we hope to prevent it.
30 The GUARDIAN study is proving we can – and should – implement genomic newborn screening at scale Analysis of 4,000 healthy infants (ongoing study, >13,000 screened to date) Nearly 4% positive rate, and 92% of positives would not have been detected with traditional NBS Average age of diagnosis for these conditions is 7-11 years old GUARDIAN is using GeneDx genome sequencing to screen 100,000 newborns for 400+ actionable genetic conditions not currently included in traditional newborn screening Published in JAMA, the Journal of the American Medical Association, in October 2024, the first phase of the GUARDIAN study:
31 Accelerate drug discovery process Guide research & development Optimize clinical trials Improve understanding of disease Increase genetic diagnoses Expand drug market access GeneDx’s data-driven solutions help to advance new therapies across the drug development pipeline – quickly and more cost-effectively Utilize data to explore genetic associations, validate hypotheses, and advance scientific knowledge Quickly discover new biomarkers and drug targets for therapeutic development and understand real-world characteristics of patient populations with improved probability of success Leverage patient medical records to expedite natural history studies to submit to regulatory agencies quicker with increased likelihood of approval Quickly identify and recruit patients, stratify study populations and optimize trial design leading to shorter and less expensive trials Help to shorten the diagnostic odyssey for rare disease patients by facilitating access to genetic testing Better understand real-world treatment patterns and efficacy outcomes, connect with patients for post- market surveillance to analyze drug safety data
32 One test. Big picture. Brighter futures.
33 Reconciliation of Non-GAAP Financial Measures Adjusted Gross Profit and Adjusted Gross Margin Three months ended September 30, Three months ended June 30, 2024 2023 2024 GeneDx Legacy Sema4 Total GeneDx Legacy Sema4 Total GeneDx Legacy Sema4 Total Revenue $ 76,622 $ 252 $ 76,874 $ 50,350 $ 2,953 $ 53,303 $ 68,924 $ 1,590 $ 70,514 Cost of services 29,045 – 29,045 27,819 225 28,044 27,417 145 27,562 Gross profit $ 47,577 $ 252 $ 47,829 $ 22,531 $ 2,728 $ 25,259 $ 41,507 $ 1,445 $ 42,952 Gross margin 62% 100% 62% 45% 92% 47% 60% 91% 61% Reconciliations: Depreciation and amortization 1,495 – 1,495 1,613 – 1,613 808 – 808 Stock-based compensation 174 – 174 75 – 75 86 – 86 Restructuring charges 6 – 6 52 – 52 – – – Adjusted gross profit $ 49,252 $ 252 $ 49,504 $ 24,271 $ 2,728 $ 26,999 $ 42,401 $ 1,445 $ 43,846 Adjusted gross margin 64% 100% 64% 48% 92% 51% 62% 91% 62%
34 Reconciliation of Non-GAAP Financial Measures Adjusted Net Income Three months ended September 30, 2024 Net loss $ (8,312) Reconciliations: Depreciation and amortization expense 5,929 Stock-based compensation expense 3,636 Restructuring costs 369 Change in fair value of financial liabilities 880 Other (1,327) Adjusted net income $ 1,175