-- Reported third quarter 2025 revenues of $116.7 million with 65%
year-over-year growth in exome and genome test revenue
-- Accelerated exome and genome volume growth to 33% year-over-year
-- Expanded adjusted gross margin to 74% and generated adjusted net
income1 of $14.7 million for the third quarter 2025
-- Raised guidance to deliver between $425 and $428 million in revenue
with between 53% to 55% full year growth in exome and genome revenue
-- Granted FDA Breakthrough Device Designation for GeneDx ExomeDx$(TM)$ and
GenomeDx(TM)
-- Leading the nation in genomic newborn screening (gNBS) as the sole
commercial testing provider for new gNBS programs, including the NIH
BEACONS initiative and Sunshine Genetics Network
-- Hosting conference call today at 8:30 a.m. ET
GAITHERSBURG, Md.--(BUSINESS WIRE)--October 28, 2025--
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 2025.
"GeneDx's accelerated growth reflects more than business momentum - it's proof of the profound impact we're making for families navigating rare disease and the broader transformation underway across healthcare," said Katherine Stueland, President and CEO of GeneDx. "The FDA's Breakthrough Device Designation for our ExomeDx(TM) and GenomeDx(TM) tests underscores our innovative leadership in delivering faster, more accurate diagnoses when every day matters. Powered by GeneDx Infinity(TM), we're helping usher in a new era of proactive, personalized care that begins at birth - advancing precision medicine to improve outcomes and change lives."
Third Quarter 2025 Financial Results (Unaudited)(1,2)
Revenues
-- Revenues grew to $116.7 million, an increase of 52% year-over-year.
-- Exome and genome test revenue grew to $98.9 million, an increase of 65%
year-over-year.
Exome and genome volume
-- Exome and genome test results volume grew to 25,702, an increase of 33%
year-over-year.
-- Exome and genome represented 43% of all tests, up from 33% in the third
quarter of 2024.
Gross margin
-- Adjusted gross margin expanded to 74%, up from 64% in the third quarter
of 2024.
-- GAAP gross margin was 72%.
Operating expenses
-- Adjusted total operating expenses were $71.2 million, representing 61%
of revenue in the third quarter of 2025, compared to 62% of revenue in
the third quarter of 2024.
-- GAAP operating expenses were $87.8 million.
Net Income
-- Adjusted net income was $14.7 million compared to $2.0 million in the
third quarter of 2024.
-- GAAP net loss was $7.6 million.
Cash position
-- Cash, cash equivalents, marketable securities and restricted cash was
$156.1 million as of September 30, 2025.
-- Cash flow for the third quarter 2025 primarily included:
-- $8.8 million in free cash flow generated; and
-- $11.8 million in proceeds, net of fees, from the issuance of
101,367 shares of Class A common stock in connection with sales
pursuant to our "at-the-market" offering.
"The third quarter delivered volume acceleration coupled with gross margin expansion, and we've established a powerful scale advantage that sets the stage for profitable growth," said Kevin Feeley, CFO of GeneDx. "As we capitalize on a rapidly expanding market, we're investing to unlock sustainable, high growth with attractive margins."
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 adjusted gross margin growth rates in the comparative 2024
period exclude revenue and costs of sales from the exited Legacy Sema4
diagnostic testing business.
GeneDx Full Year 2025 Guidance
GeneDx has raised certain elements of its full year 2025 guidance and expects to deliver:
Metric Previous Guidance Updated Guidance
----------------------- ------------------------
Revenue $400 to $415 million $425 to $428 million
Growth in exome and
genome revenue 48% to 52% 53% to 55%
Growth in exome and
genome volume At least 30% At least 30%
Adjusted gross margin 68% to 71% 70% to 71%
Adjusted net income Positive each quarter Positive each quarter
and for full year and for full year
Third Quarter 2025 and Recent Business Highlights
Strategic Expansion and Market Leadership
-- Introduced GeneDx Infinity(TM), the largest rare disease dataset, which
serves as the foundation for rare disease insights and powers GeneDx's
ExomeDx(TM) and GenomeDx(TM).
-- Exhibited at the American Academy of Pediatrics $(AAP)$ Annual Meeting,
educating pediatricians about the updated AAP guidance recommending exome
and genome sequencing as first-tier tests for children with global
developmental delay or intellectual disability.
-- Expanded coverage of whole genome sequencing with California Medicaid
(Medi-Cal), opening access to testing in the nation's most populous state
and bringing the number of states covering exome or genome testing in the
outpatient setting to 36.
-- Announced the Autism Partnership Program in partnership with Jaguar
Gene Therapy, expanding access to exome and genome testing for patients
suspected of having SHANK3-related autism spectrum disorder (ASD) and
Phelan-McDermid syndrome - the leading single-gene cause of ASD.
-- Appointed Lisa Gurry as Chief Business Officer and Dr. Mimi Lee as
Chief Precision Medicine Officer to accelerate precision medicine across
policymakers, health systems, biopharmaceutical companies, advocacy
groups, and payers to help more families with the power of data, AI, and
clinical expertise.
-- Appointed Dr. Thomas Fuchs, MD, PhD, to the board of directors,
contributing his background at the intersection of AI and human health to
support GeneDx's business and mission.
Innovation & Clinical Leadership
-- Granted FDA Breakthrough Device Designation for GeneDx ExomeDx(TM) and
GenomeDx(TM) associated with causes of life-threatening diseases or
genetic disorders to aid in diagnosis of symptomatic patients,
underscoring GeneDx's leadership in genomic medicine and critical role in
delivering fast, accurate answers for patients with rare diseases.
-- Expanded leadership in genomic newborn screening through participation
in key programs, including:
-- Announced participation in the nation's first multi-state
genomic newborn screening initiative, BEACONS (Building Evidence
and Collaboration for GenOmics in Nationwide Newborn Screening),
which was launched with a $14.4 million NIH award to enroll up to
30,000 newborns in as many as 10 states over the next three
years.
-- Announced a partnership with Florida's Sunshine Genetics Network
to launch the nation's first state-backed genomic newborn
screening program and offer whole genome sequencing for newborns
at select academic medical centers and hospitals, providing
families and clinicians the opportunity for early detection and
diagnosis of rare diseases.
-- Added to the company's 1,000+ publications and growing by showcasing
pioneering research at the American Society of Human Genetics (ASHG)
Annual Meeting including:
-- AI and machine learning approaches in rare disease diagnosis: In
a study of over 250,000 exome and genome trios, GeneDx's machine
learning approach addresses challenges of identifying de novo
variants with high accuracy and throughput, enabling greater
efficiency and scalability.
-- The genetic causes of autism: In a study of over 62,000
individuals affected with autism, researchers highlight a core set
of over 250 genes associated with autism and found moderate
genetic correlations between autism and schizophrenia, epilepsy,
and bipolar disorder.
-- Genomic newborn screening (gNBS): Updated results from the
GUARDIAN study reports data from 15,000 newborns and demonstrates
high enrollment rates, positive parental experiences, and
meaningful follow-up outcomes -- reinforcing the value of gNBS in
accelerating time to diagnosis.
-- Clinical validation for long read sequencing: Long-read
sequencing approaches demonstrate strong potential to improve
clinical diagnostics, accurately detecting repeat expansions and
resolving difficult-to-sequence regions.
-- Showcased leadership in genomic newborn screening at the International
Consortium of Newborn Sequencing (ICoNS), with data presented on GeneDx's
more than 22,000 newborns sequenced.
Webcast and Conference Call Details
GeneDx will host a conference call today, October 28, 2025, 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 "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the U.S. Private Securities Litigation Reform Act of 1995, including statements regarding our future performance and our market opportunity, including our expected full year 2025 reported revenue, growth in exome and genome revenue and volume, adjusted gross margin and adjusted net income guidance. 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, and (iv) our ability to pursue our new strategic direction. The foregoing list of factors is not exhaustive. A further list and description of risks, uncertainties and other matters can be found in the "Risk Factors" section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and our Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2025, June 30, 2025 and September 30, 2025, 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) is the global leader in rare disease diagnosis, transforming the way medicine is practiced by making genomics the starting point for health, not the last resort. We bring together unmatched clinical expertise, advanced technology, and the power of GeneDx Infinity(TM) -- the largest rare disease dataset -- built over 25 years from millions of genomic tests and deep clinical insights. This unparalleled foundation powers our ExomeDx(TM) and GenomeDx(TM) tests, giving clinicians the highest likelihood of delivering a timely, accurate diagnosis. GeneDx is shaping the future of healthcare by moving the standard of care from sick care to proactive healthcare. While our roots are in rare disease diagnosis, our commitment extends beyond -- growing with the families we serve -- as a trusted partner at every stage of life. For more information, visit genedx.com and connect with us on LinkedIn, Facebook, and Instagram.
Volume & Revenue (1,2)
3Q25 2Q25 1Q25 4Q24 3Q24
------- ------- ------- ------- ----------
Volumes
Whole exome,
whole genome 25,702 23,246 20,562 20,676 19,262
Hereditary
cancer 1,511 2,677 2,725 3,486 4,672
Other panels 33,003 31,833 28,228 30,115 35,095
------ ------ ------ ------ ------
Total 60,216 57,756 51,515 54,277 59,029
====== ====== ====== ====== ======
Revenue ($
millions)
Whole exome,
whole genome $ 98.9 $ 86.0 $ 71.4 $ 78.8 $ 60.0
Hereditary
cancer 1.2 1.8 2.2 2.8 3.3
Other panels 13.4 12.3 12.1 12.3 13.8
Data
information 1.5 2.0 1.4 1.4 (0.5)
Software and
interpretation
services 1.7 0.6 -- -- --
------ ------ ------ ------ ------
Total $ 116.7 $ 102.7 $ 87.1 $ 95.3 $ 76.6
====== ====== ====== ====== ======
1. Excludes volume and revenue from the exited Legacy Sema4
diagnostic testing business for the third and fourth quarters of
2024.
2. Diagnostic testing volume and revenue amounts for the second
quarter of 2025 revised to conform with current period
presentation combining GeneDx and Fabric Genomics.
Unaudited Select Financial Information (in thousands)
Three months ended September Three months ended September
30, 2025 30, 2024
----------------------------- -----------------------------
GeneDx Other(1) Total GeneDx Other(1) Total
-------- -------- --------- ------- -------- ----------
Revenue $114,697 $2,046 $116,743 $76,622 $252 $76,874
Adjusted
cost of
services 30,246 377 30,623 27,370 -- 27,370
-------- -------- --------- ------- -------- ----------
Adjusted
gross
profit $84,451 $1,669 $86,120 $49,252 $252 $49,504
Adjusted
gross
margin
% 73.6% 81.6% 73.8% 64.3% 100.0% 64.4%
1. Other includes revenue and cost of services from the Fabric Genomics
operating segment for the three months ended September 30, 2025. For the
three months ended September 30, 2024, Other includes revenue from the
Legacy Sema4 diagnostic testing business.
Three months ended September 30, 2025
-----------------------------------------------------------------------------------------------------------
Stock-based Change in FV
Depreciation and compensation Restructuring of financial
Reported amortization expense costs liabilities Other(2) Adjusted
------------ ---------------- ---------------- ----------------- ------------ ---------- ------------
Diagnostic test
revenue $113,523 $ -- $ -- $ -- $ -- $ -- $113,523
Other revenue 3,220 -- -- -- -- -- 3,220
------- ------- --- ------ ---- ----- ------ ----------- ----- -------
Total revenue 116,743 -- -- -- -- -- 116,743
Cost of
services 32,216 (1,374) (219) -- -- -- 30,623
------- ------- ------ --- ----- ------ ----------- ----- -------
Gross profit 84,527 1,374 219 -- -- -- 86,120
Gross margin 72.4% 73.8%
Research and
development 19,829 (242) (1,749) 196 -- -- 18,034
Selling and
marketing 23,510 (1,334) (1,674) (136) -- -- 20,366
General and
administrative 44,439 (3,524) (6,944) (188) -- (974) 32,809
(Loss) income
from
operations (3,251) 6,474 10,586 128 -- 974 14,911
Interest
expense, net (562) -- -- -- -- 562 --
Other income
(expense),
net (3,575) -- -- -- 3,401 (2) (176)
Income tax
expense (247) -- -- -- -- 247 --
------- ------- --- ------ ---- ----- ------ ----------- ----- -------
Net (loss)
income $ (7,635) $ 6,474 $ 10,586 $ 128 $ 3,401 $ 1,781 $ 14,735
======= ======= === ====== ==== ===== ====== =========== ===== =======
Basic (loss)
earnings per
share(1) $ (0.27) $ 0.51
Diluted (loss)
earnings per
share(1) $ (0.27) $ 0.49
Three months ended September 30, 2024
-------------------------------------------------------------------------------------------------------
Stock-based Change in FV
Depreciation and compensation Restructuring of financial
Reported amortization expense costs liabilities Other(2) 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 26,919 (2,987) (2,531) (308) -- -- 21,093
(Loss) income
from
operations (7,780) 5,929 3,636 369 -- -- 2,154
Interest
expense, net (843) -- -- -- -- 843 --
Other income
(expense),
net 264 -- -- -- 880 (1,327) (183)
Income tax
benefit 47 -- -- -- -- (47) --
------ ------- --- ------ ---- ----- ------ ----------- ------ ------
Net (loss)
income $(8,312) $ 5,929 $ 3,636 $ 369 $ 880 $ (531) $ 1,971
====== ======= === ====== ==== ===== ====== =========== ====== ======
Basic (loss)
earnings per
share(1) $ (0.31) $ 0.07
Diluted (loss)
earnings per
share(1) $ (0.31) $ 0.07
1. Basic and diluted (loss) earnings per share are calculated based on 28,797,730 and 30,152,510 weighted average shares
outstanding for the three months ended September 30, 2025, respectively, and 27,095,986 and 28,836,909 weighted average
shares outstanding for the three months ended September 30, 2024, respectively.
2. Other represents interest expense, net, and income tax (expense) benefit for all periods presented. For the three
months ended September 30, 2025, Other includes costs related to legal reserves. For the three months ended September 30,
2024, Other includes reserves, net of insurance related to a legal settlement.
GeneDx Holdings Corp.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
September 30, 2025 (Unaudited) December 31, 2024
------------------------------ ---------------------
Assets:
Current assets:
Cash and cash
equivalents $ 95,968 $ 85,212
Marketable
securities 59,111 55,973
Accounts
receivable 60,938 37,629
Inventory, net 10,569 10,650
Prepaid expenses
and other
current assets 10,997 8,504
----- ------------------- --------------
Total current
assets 237,583 197,968
Operating lease
right-of-use
assets 24,200 25,613
Property and
equipment, net 42,422 32,893
Goodwill 12,798 --
Intangible assets,
net 172,585 158,600
Other assets(1) 4,314 4,306
----- ------------------- --------------
Total assets $ 493,902 $ 419,380
===== =================== ==============
Liabilities and
Stockholders'
Equity:
Current liabilities:
Accounts payable
and accrued
expenses $ 50,334 $ 30,983
Short-term lease
liabilities 4,429 3,336
Other current
liabilities 32,858 20,498
----- ------------------- --------------
Total current
liabilities 87,621 54,817
Long-term debt, net
of current portion 51,579 51,913
Long-term lease
liabilities 57,153 60,919
Other liabilities 4,258 5,519
Deferred taxes 1,033 965
----- ------------------- --------------
Total
liabilities 201,644 174,133
----- ------------------- --------------
Stockholders'
Equity:
Preferred stock -- --
Class A common
stock 2 2
Additional paid-in
capital 1,647,083 1,596,889
Accumulated deficit (1,355,829) (1,352,474)
Accumulated other
comprehensive
income 1,002 830
----- ------------------- --------------
Total
stockholders'
equity 292,258 245,247
----- ------------------- --------------
Total
liabilities
and
stockholders'
equity $ 493,902 $ 419,380
===== =================== ==============
1. Other assets includes $1.0 million of restricted cash as of both
September 30, 2025 and December 31, 2024.
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,
-------------------------- -------------------------------
2025 2024 2025 2024
------------ ------------ --------------- --------------
Revenue
Diagnostic test
revenue $ 113,523 $ 77,418 $ 299,382 $ 207,961
Other revenue 3,220 (544) 7,168 1,849
---------- ---------- ---------- ----------
Total revenue 116,743 76,874 306,550 209,810
---------- ---------- ---------- ----------
Cost of services 32,216 29,045 92,645 81,618
---------- ---------- ---------- ----------
Gross profit 84,527 47,829 213,905 128,192
---------- ---------- ---------- ----------
Research and
development 19,829 11,665 47,485 34,134
Selling and
marketing 23,510 17,025 61,274 49,695
General and
administrative 44,439 26,919 103,988 76,382
---------- ---------- ---------- ----------
Loss (income)
from
operations (3,251) (7,780) 1,158 (32,019)
---------- ---------- ---------- ----------
Non-operating
(expenses) income,
net
Change in fair value
of financial
liabilities (3,401) (880) (2,320) (11,390)
Interest expense,
net (562) (843) (2,019) (2,334)
Other (expense)
income, net (174) 1,144 274 (12,300)
---------- ---------- ---------- ----------
Total
non-operating
expense, net (4,137) (579) (4,065) (26,024)
---------- ---------- ---------- ----------
Loss before income
taxes (7,388) (8,359) $ (2,907) $ (58,043)
Income tax (expense)
benefit (247) 47 (448) 319
---------- ---------- ---------- ----------
Net loss $ (7,635) $ (8,312) $ (3,355) $ (57,724)
========== ========== ========== ==========
Weighted-average
shares outstanding
of Class A common
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