EX-99.1 2 q32024pressrelease.htm EX-99.1 Document
附錄99.1
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GeneDx公佈2024年第三季度財務業績和業務亮點。
達成了盈利里程碑，第三季度調整後的凈利潤1 為120萬美元
2024年第三季度營業收入報告2 為7660萬美元，外显子和基因组测试收入同比增长77%
2024年第三季調整後毛利擴大。2 至64%
調高指引，預計在2024財政年度營業收入介於2,8400萬和2,9000萬之間
GeneDx將在今天早上8:30美東時間舉行投資者電話會議。

2024年10月29日，康涅狄格州史坦佛 - genedx holdings corp.(納斯達克：WGS)，作為透過基因組洞察提供提升健康成果的領導者，今天公佈了其2024年第三季度的財務報告。
GeneDx的首席執行官Katherine Stueland表示：“在第三季度，我們的全外显子和基因组收入增长了77％，已經實現盈利，這是我們公司歷史上的一個重要里程碑。我們在基因组學方面的進步正在重新定義護理標準，為臨床效用和經濟效率設定新的行業標準，縮短了成千上萬家庭確診的時間。隨著越來越多家庭有資格使用我們的服務，我們的成長前景健康且持續。我們繼續為兒科門診和新生兒重症監護室帶來改變生活的影響，現在我們正在建立可操作、負責任且可擴展的基因組新生兒篩查基礎。”
“再次，我們本季的業績超出了我們的頂線和底線預期。第三季度標誌著我們連續第10個季度的現金流改善，我們超前了我們之前的調整後凈利潤目標，” GeneDx的CFO Kevin Feeley表示。“憑藉我們在行業板塊中領先的科技和龐大的市場機遇，GeneDx將繼續將財務紀律與戰略投資相結合，加快業務發展，為更多有需要的家庭提供答案。”

2024年第三季度財務業績報告（未經審核）1,2
收入
•持續營運收入增長至7660萬美元，年增52％，環比增長11％。
◦公司總收入為7690萬美元。
•外顯子組和基因組測試的營業收入增長至6000萬，較去年增長77%，較前一季增長18%。
外显子和基因组成交量
•外显子和基因组检测结果的成交量增长至19,262，同比增长46％，按季环比增长7％。
•外显子组和基因组所占所有测试结果的比例为33%，较2023年第三季度的23%提高，较2024年第二季度的31%增加。
毛利率
•持續經營的調整後毛利率擴大至64%，較2023年第三季度的48%增長，較2024年第二季度的62%增長。
◦公司總毛利率為62%。
營運費用
•調整後的總營業費用為4660萬美元，同比減少2%，環比增加4%。
◦總計GAAP營業費用為$5480萬。


凈利潤（虧損）
•調整後的凈利潤改善至120萬美元，同比增長106%，環比增長143%。
◦根據一般公認會計原則（GAAP），淨虧損為830萬美元。
現金燃燒和現金位置
•2024年第三季度的現金淨使用總額為500萬美元，較去年同期改善了88%，較上季度改善了17%。
•截至2024年9月30日，現金、現金等價物、市場證券及受限現金總額為11740萬美元，其中包括從2024年第三季度的「市場現售」發行418,653股A類普通股所獲得的1460萬美元的收益（扣除費用後）。

GeneDx 2024 全年指引
GeneDx已更新2024年全年指引。管理層預期GeneDx將會：
•推動2024年全年營收2 介於284萬至29000萬（之前的指引是介於255萬至26500萬）;
•擴大至全年2024年調整後的毛利率2 至少提高到62％（先前指引為至少60％）；
•2024年全年凈現金使用範圍介乎6000萬至6500萬美元（先前指引為6500萬至7000萬美元）
1.調整後毛利率、調整後總營業費用和調整後凈利潤（虧損）均為非美國通用會計準則財務指標。請參閱附錄，以了解美國通用會計準則與非美國通用會計準則數字之對應。
2.持續運營的營業收入和毛利率結果，我們相信這些結果代表了我們正在進行的業務策略，並不包括退出的Legacy Sema4診斷測試業務在當前及所有比較期間的任何營業收入和營業成本。公司的總體結果相應標註，並包括GeneDx的持續運營以及退出的Legacy Sema4業務活動在當前及所有比較期間的財務影響。

2024年第三季業務亮點
推動可持續增長，擴大更多患者群體的接觸
•達成超過700,000個臨床外顯子體和基因組的序列，僅在過去六個月內就完成了超過100,000個。
•州政府醫療補助計劃加快採用全外顯子組測序（WES）和全基因組測序（WGS）的覆蓋範圍，使覆蓋兒科門診診斷的州數達到30個。
◦印第安納州 - WES 和 WGS（2024年7月）
◦康涅狄格 - WGS（2024年7月）
◦德克薩斯州 - WGS (2024年9月)
◦佛羅里達 - WGS（2024年10月）
•醫療保險與醫療補助服務中心對各州醫療補助機構發布了「歷史性的指導」，強調他們有責任根據早期和定期篩查、診斷和治療（EPSDT）福利提供所有醫療必要服務。
◦根據EPSDt，所有21歲以下的醫療補助註冊兒童都有權獲得符合他們獨特醫療需求的服務。這些服務包括基因組和外顯子組測序等診斷——這些是我們用來解鎖這些兒童所需適切護理、治療和關鍵壓力位的最強大工具之一。
•擴展了癲癇合作夥伴計劃，這是一個首創的病人獲取計劃，旨在提高兒童癲癇患者對外顱組學和基因組學測序的獲取，並新增了一個生物製藥合作夥伴。
•與英國威康桑格研究所的研究人員合作，發布了迄今最大的多樣性研究數據，其中包括來自3萬多名患者的數據，研究隱性基因變化如何促進兒童發育障礙。
◦2024年9月23日，該研究的結果發表在《自然遺傳學》上，顯示大多數新的隱性發育障礙診斷都位於已知基因內。
◦該出版物進一步證明了我們對於基因組學中多樣性重要角色的承諾，以及我們相信服務於更具多樣性的患者群體能為來自所有背景的患者提供更明確的診斷。


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
3Q242Q241Q244Q233Q23
Volumes
Whole exome, whole genome19,26218,01716,59215,66313,216
Hereditary cancer4,6725,4826,8688,2408,556
Other panels35,09534,20431,76333,69235,861
Total59,02957,70355,22357,59557,633
Revenue ($ millions)
Whole exome, whole genome$60.0 $50.7 $44.0 $39.2 $34.0 
Hereditary cancer3.3 3.8 5.5 5.5 4.5 
Other panels13.8 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, 2024Three months ended June 30, 2024
GeneDxLegacy Sema4TotalGeneDxLegacy Sema4Total
Revenue$76,622$252$76,874$68,924$1,590$70,514
Adjusted cost of services27,370—27,37026,52314526,668
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
GeneDxLegacy Sema4Total
Revenue$50,350$2,953$53,303
Adjusted cost of services26,07922526,304
Adjusted gross profit$24,271$2,728$26,999
Adjusted gross margin %48.2%92.4%50.7%


Three months ended September 30, 2024
ReportedDepreciation and amortizationStock-based compensation expenseRestructuring costsChange in FV of financial liabilitiesCharges related to business exitOtherAdjusted
Diagnostic test revenue$77,418 $— $— $— $— $— $— $77,418 
Other revenue(544)— — — — — — (544)
Total revenue76,874 — — — — — — 76,874 
Cost of services29,045 (1,495)(174)(6)— — — 27,370 
Gross profit47,829 1,495 174 6 — — — 49,504 
Gross margin62.2 %64.4 %
Research and development11,665 (222)(537)— — — — 10,906 
Selling and marketing17,025 (1,225)(394)(55)— — — 15,351 
General and administrative26,145 (2,987)(2,531)(308)— — — 20,319 
Impairment loss— — — — — — — — 
Other, net774 — — — — — — 774 
Loss from operations(7,780)5,929 3,636 369 — — — 2,154 
Interest income (expense), net(843)— — — — — — (843)
Other income (expense), net264 — — — 880 — (1,327)(183)
Income tax benefit47 — — — — — — 47 
Net income (loss)$(8,312)$5,929 $3,636 $369 $880 $— $(1,327)$1,175 
Three months ended September 30, 2023
ReportedDepreciation and amortizationStock-based compensation expenseRestructuring costsChange in FV of financial liabilitiesCharges related to business exitOtherAdjusted
Diagnostic test revenue$51,955 $— $— $— $— $— $— $51,955 
Other revenue1,348 — — — — — — 1,348 
Total revenue53,303 — — — — — — 53,303 
Cost of services28,044 (1,613)(75)(52)— — — 26,304 
Gross profit25,259 1,613 75 52 — — — 26,999 
Gross margin47.4 %50.7 %
Research and development14,288 (283)533 (970)— — — 13,568 
Selling and marketing16,763 (1,225)115 (415)— — — 15,238 
General and administrative26,099 (5,551)(1,004)(754)— — — 18,790 
Impairment loss8,282 — — — — (8,282)— — 
Other, net2,794 — — — — (1,014)— 1,780 
Loss from operations(42,967)8,672 431 2,191 — 9,296 — (22,377)
Interest income (expense), net1,053 — — — — — — 1,053 
Other income (expense), net(544)— — — (590)— 1,134 — 
Income tax benefit172 — — — — — — 172 
Net loss$(42,286)$8,672 $431 $2,191 $(590)$9,296 $1,134 $(21,152)
Three months ended June 30, 2024
ReportedDepreciation and amortizationStock-based compensation expenseRestructuring costsChange in FV of financial liabilitiesCharges related to business exitOtherAdjusted
Diagnostic test revenue$69,439 $— $— $— $— $— $— $69,439 
Other revenue1,075 — — — — — — 1,075 
Total revenue70,514 — — — — — — 70,514 
Cost of services27,562 (808)(86)— — — — 26,668 
Gross profit42,952 808 86 — — — — 43,846 
Gross margin60.9 %62.2 %
Research and development10,902 (211)(347)(35)— — — 10,309 
Selling and marketing16,585 (1,225)(368)(63)— — — 14,929 
General and administrative25,170 (2,974)(2,307)(150)— — — 19,739 
Impairment loss— — — — — — — — 
Other, net874 — — — — — — 874 
Loss from operations(10,579)5,218 3,108 248 — — — (2,005)
Interest income (expense), net(894)— — — — — — (894)
Other income (expense), net(17,890)— — — 4,409 — 13,450 (31)
Income tax benefit190 — — — — — — 190 
Net loss$(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 securities58,566 30,467 
Accounts receivable38,220 32,371 
Due from related parties260 445 
Inventory, net10,770 8,777 
Prepaid expenses and other current assets20,300 10,598 
Total current assets186,010 182,339 
Operating lease right-of-use assets24,936 26,900 
Property and equipment, net31,452 32,479 
Intangible assets, net162,106 172,625 
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 parties727 1,379 
Short-term lease liabilities3,698 3,647 
Other current liabilities16,501 16,336 
Total current liabilities77,342 58,818 
Long-term debt, net of current portion52,034 52,688 
Long-term lease liabilities60,369 62,938 
Other liabilities13,540 14,735 
Deferred taxes1,054 1,560 
Total liabilities204,339 190,739 
Stockholders’ Equity:
Preferred stock— — 
Class A common stock2 2 
Additional paid-in capital1,561,493 1,527,778 
Accumulated deficit(1,357,912)(1,300,188)
Accumulated other comprehensive income918 425 
Total stockholders’ equity204,501 228,017 
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,
2024202320242023
Revenue
Diagnostic test revenue$77,418 $51,955 $207,961 $140,440 
Other revenue(544)1,348 1,849 4,708 
Total revenue76,874 53,303 209,810 145,148 
Cost of services    29,045 28,044 81,618 85,896 
Gross profit47,829 25,259 128,192 59,252 
Research and development11,665 14,288 34,134 46,018 
Selling and marketing17,025 16,763 49,695 45,397 
General and administrative26,145 26,099 73,760 107,129 
Impairment loss— 8,282 — 10,402 
Other operating expenses, net774 2,794 2,622 5,259 
Loss from operations(7,780)(42,967)(32,019)(154,953)
Non-operating income (expenses), net
Change in fair value of warrants and earn-out contingent liabilities (880)590 (11,390)684 
Interest (expense) income, net(843)1,053 (2,334)2,092 
Other income (expense), net1,144 (1,134)(12,300)1,668 
Total non-operating income (expense), net(579)509 (26,024)4,444 
Loss before income taxes(8,359)(42,458)$(58,043)$(150,509)
Income tax benefit47 172 319 515 
Net loss$(8,312)$(42,286)$(57,724)$(149,994)
Weighted average shares outstanding of Class A common stock27,095,98625,788,74726,593,87723,777,327
Basic and diluted net loss per share, Class A common stock$(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,
20242023
Operating activities
Net loss$(57,724)$(149,994)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization expense16,395 27,640 
Stock-based compensation expense6,293 586 
Change in fair value of warrants and contingent liabilities11,390 (684)
Deferred tax benefit(319)(515)
Provision for excess and obsolete inventory137 3,634 
Legal reserves12,123 — 
Change in third party payor reserves737 (6,848)
Gain on sale of assets— (2,954)
Gain on debt forgiveness— (2,750)
Impairment loss— 10,402 
Other2,639 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 securities598 — 
Proceeds from maturities of marketable securities24,955 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 costs14,589 143,002 
Exercise of stock options247 266 
Long-term debt principal payments(198)(2,000)
Finance lease payoff and principal payments(1,499)(2,133)
Net cash provided by financing activities13,139 139,135 
Net decrease in cash, cash equivalents and restricted cash (41,787)(50,016)
Cash, cash equivalents and restricted cash, at beginning of period100,668 138,303 
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.