Financial Data and Key Metrics Changes - First quarter 2024 revenues from continuing operations grew to $61.5 million, an increase of 51% year-over-year and 6% sequentially [16] - Adjusted gross margin from continuing operations was 61%, up from 34% a year ago and 56% in the fourth quarter of 2023 [19] - Total adjusted operating expense was $45.4 million, a reduction of 26% year-over-year and 6% sequentially [25] - Total company adjusted net loss for the first quarter narrowed to $8.5 million, an improvement of 83% year-over-year and 52% sequentially [25] - Cash burn for the first quarter was $17.2 million, improving 71% year-over-year and 48% sequentially [27] Business Line Data and Key Metrics Changes - The company delivered more than $61 million in revenues, with 30% of tests being exome and genome, representing over 70% of total revenue [11][12] - The company performed over 16,500 whole exome and genome tests, generating $44 million in revenue from this portfolio, a 96% increase year-over-year [16] - Average reimbursement for the exome and genome portfolio was approximately $2,600, up from $2,500 in the previous quarter [21] Market Data and Key Metrics Changes - The company operates with 80% of all clinical exomes being run at GeneDx, targeting geneticists and pediatric specialists [13] - Medicaid policy is expanding, with two states adding coverage for rapid whole genome testing and New York State adding exome coverage effective April 1, 2024 [23] Company Strategy and Development Direction - The company is focused on driving exome utilization, improving average reimbursement rates, and reducing cash burn [11] - The strategy includes transitioning from single-gene testing to exome and genome testing, aiming to set a new standard in clinical care [31] - The company plans to introduce GeneDx to broader populations over time, focusing on hereditary diseases [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver profitable growth and raised annual revenue guidance to $235 million to $245 million [11][28] - The management highlighted the importance of the FDA's new LDT guidance and its potential impact on the market [84] - The company expects to turn profitable in 2025, with a commitment to improving operational efficiency [29] Other Important Information - The company has interpreted over 600,000 clinical exomes since 2012, with significant growth in the last three years [9] - The company has entered into a 5-year senior secured credit facility with Perceptive Advisors, providing up to $75 million in capacity [26] Q&A Session Summary Question: Comments on the FDA LDT guidance and its impact - Management is reviewing the 500+ page document and believes it presents a good opportunity, having prepared for this new era of FDA regulation [84] Question: Visibility in the business and improvements over the last quarters - Management noted that the team is well poised to understand effective call points and is confident in the strategy moving forward [39][40] Question: Clarification on profitability guidance for 2025 - Management reiterated the expectation of profitability in 2025, with a specific quarter expected to show that turn [49] Question: Sequential revenue growth expectations - Management indicated that consistent robust revenue growth is expected, particularly in exome testing, while cautioning about potential declines in non-exome testing lines [51] Question: Update on reimbursement and denial rates - Management confirmed that improvements in average reimbursement rates were due to reductions in denials, which remain a challenge with a denial rate just above 50% [52] Question: Success in converting accounts from Invitae - Management reported success in converting accounts, particularly in the pediatric neurology market, and expects continued conversion from panels to exomes [61] Question: Education and awareness regarding exome testing - Management emphasized the importance of data in educating clinicians and plans to focus on pediatric neurologists and specialists to drive exome utilization [66]

GeneDx Holdings Corp. (WGS) came out with a quarterly loss of $0.33 per share versus the Zacks Consensus Estimate of a loss of $0.68. This compares to loss of $2.82 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 51.47%. A quarter ago, it was expected that this company would post a loss of $0.60 per share when it actually produced a loss of $0.59, delivering a surprise of 1.67%.Over the last four quarters, the company has surp ...

[Part I. Financial Information](index=4&type=section&id=Part%20I.%20Financial%20Information) This section details the company's unaudited condensed consolidated financial statements and management's analysis of financial condition [Item 1. Condensed Consolidated Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20%28Unaudited%29) GeneDx Holdings Corp. reported significant Q1 2024 financial improvement with 45% revenue growth, reduced net loss, and improved cash flow [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2024, the company's balance sheet showed total assets of $394.5 million, a decrease from $418.8 million at year-end 2023 Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2024 (Unaudited) | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $83,673 | $99,681 | | Total current assets | $163,424 | $182,339 | | Total assets | $394,528 | $418,756 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $50,734 | $58,818 | | Total liabilities | $187,311 | $190,739 | | Total stockholders' equity | $207,217 | $228,017 | | Total liabilities and stockholders' equity | $394,528 | $418,756 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company achieved strong Q1 2024 revenue growth and significant reduction in operating and net losses Q1 2024 vs Q1 2023 Statement of Operations (in thousands, except per share data) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Total revenue | $62,422 | $43,139 | | Gross profit | $37,411 | $15,236 | | Loss from operations | ($13,660) | ($60,364) | | Net loss | ($20,239) | ($60,989) | | Basic and diluted net loss per share | ($0.78) | ($3.04) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities significantly decreased in Q1 2024, reflecting improved operational efficiency Cash Flow Summary (in thousands) | Activity | Three months ended March 31, 2024 | Three months ended March 31, 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($16,413) | ($55,560) | | Net cash provided by (used in) investing activities | $843 | ($462) | | Net cash (used in) provided by financing activities | ($438) | $132,658 | | **Net (decrease) increase in cash** | **($16,008)** | **$76,636** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail accounting policies, revenue concentration, warrant liability, and segment reporting, including the Legacy Sema4 shutdown - Two major payors, Payor A and Payor B, accounted for **19% and 30% of total revenues**, respectively, for the three months ended March 31, 2024, indicating a significant concentration of credit risk[31](index=31&type=chunk) - The company recorded a **$5.0 million loss** for the three months ended March 31, 2024, due to the change in fair value of the Perceptive Warrants, primarily driven by an increase in the company's stock price[53](index=53&type=chunk) - The company's operations are divided into two reportable segments: GeneDx (pediatric and rare disease diagnostics) and Legacy Sema4 diagnostics (reproductive/women's health and somatic oncology), with the latter being **completely shut down**[94](index=94&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2024 revenue growth driven by test volumes, improved gross profit, reduced operating expenses, and liquidity Q1 2024 vs Q1 2023 Results of Operations (in thousands) | Line Item | Q1 2024 | Q1 2023 | $ Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Total revenue | $62,422 | $43,139 | $19,283 | 45% | | Gross profit | $37,411 | $15,236 | $22,175 | 146% | | Research and development | $11,567 | $14,592 | ($3,025) | (21)% | | General and administrative | $22,445 | $43,689 | ($21,244) | (49)% | | Loss from operations | ($13,660) | ($60,364) | $46,704 | (77)% | | Net loss | ($20,239) | ($60,989) | $40,750 | (67)% | - The increase in diagnostic test revenue was primarily driven by a **$21.6 million (96%) increase** in whole exome and genome sequencing revenues, resulting from a **91% increase in test volumes**[129](index=129&type=chunk) - The company resulted **55,223 tests** in Q1 2024, an increase from 52,778 tests in Q1 2023[114](index=114&type=chunk) Reconciliation of Net Loss to Adjusted Net Loss (Non-GAAP, in thousands) | | Three months ended March 31, | | :--- | :--- | :--- | | | **2024** | **2023** | | Net loss | $(20,239) | $(60,989) | | Depreciation and amortization expense | 5,248 | 8,636 | | Stock-based compensation expense | (451) | 48 | | Impairment loss | — | 2,120 | | Restructuring costs | 843 | 702 | | Change in fair value of financial liabilities | 6,101 | 3,453 | | Gain on debt forgiveness | — | (2,750) | | **Adjusted net loss** | **$(8,498)** | **$(48,780)** | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk exposure is to interest rates, affecting its cash, marketable securities, and variable rate debt - The company is exposed to interest rate risk on its cash, cash equivalents, and marketable securities, which totaled **$113.9 million** at March 31, 2024[163](index=163&type=chunk) - The company is also exposed to interest rate risk on its variable rate debt associated with the Perceptive term loan facility, which can impact future interest payments[164](index=164&type=chunk) [Item 4. Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were ineffective due to an un-remediated material weakness in IT general controls as of March 31, 2024 - The CEO and CFO concluded that disclosure controls and procedures were **not effective** as of March 31, 2024[166](index=166&type=chunk) - The ineffectiveness is due to a **material weakness** in internal control over financial reporting related to IT general controls (ITGCs) over access and program change management, which has not been fully remediated[166](index=166&type=chunk)[169](index=169&type=chunk) - Despite the material weakness, management concluded that the condensed consolidated financial statements are **fairly stated** in all material respects in accordance with U.S. GAAP[167](index=167&type=chunk) [Part II. Other Information](index=32&type=section&id=Part%20II.%20Other%20Information) This section provides additional information including legal proceedings, risk factors, equity sales, and other disclosures [Item 1. Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company is subject to various legal actions, including shareholder class actions and a derivative suit, which it believes are without merit - A shareholder class action lawsuit filed in September 2022 alleges false and misleading statements between March and August 2022. A motion to dismiss is pending[79](index=79&type=chunk) - A stockholder lawsuit filed in February 2023 in Delaware alleges false and misleading statements in the proxy statement for the 2021 Business Combination[80](index=80&type=chunk) - A derivative suit was filed in November 2023 on behalf of the company against certain former and current officers and directors, based on similar allegations as the securities class action[81](index=81&type=chunk) [Item 1A. Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) The company updates risk factors regarding potential FDA regulation of LDTs and increasing compliance costs for privacy laws - The FDA has published a proposed rule to end its enforcement discretion for Laboratory Developed Tests (LDTs) in five stages over four years, which could subject the company's tests to extensive FDA requirements, including premarket review[178](index=178&type=chunk) - Compliance with HIPAA and other privacy laws, including recent updates from the Office for Civil Rights (OCR) regarding online tracking technologies, may increase costs and expose the company to significant fines and penalties for non-compliance or data breaches[180](index=180&type=chunk)[182](index=182&type=chunk)[183](index=183&type=chunk) [Item 2. Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities](index=33&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%2C%20Use%20of%20Proceeds%2C%20and%20Issuer%20Purchases%20of%20Equity%20Securities) During the period covered by this report, the company did not have any unregistered sales or issuer purchases of its equity securities - There were **no unregistered sales** of equity securities during the quarter[187](index=187&type=chunk) - There were **no issuer purchases** of equity securities during the quarter[188](index=188&type=chunk) [Item 5. Other Information](index=34&type=section&id=Item%205.%20Other%20Information) This section updates disclosures on government regulations, including PAMA, state privacy laws, and the 21st Century Cures Act - The company provides a supplemental disclosure updating its discussion of the Protecting Access to Medicare Act (PAMA), noting that the next private payor rate reporting period is in 2025 to establish rates for 2026-2028[190](index=190&type=chunk)[192](index=192&type=chunk) - An update on the California Consumer Privacy Act (CCPA) and other new state privacy laws is provided, noting the increasing compliance obligations for businesses[197](index=197&type=chunk)[200](index=200&type=chunk) - The company updated its disclosure on the 21st Century Cures Act's information blocking prohibition, noting a final rule from HHS Office of Inspector General regarding civil monetary penalties became effective in September 2023[201](index=201&type=chunk) [Item 6. Exhibits](index=36&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Quarterly Report on Form 10-Q, including certifications and XBRL data files - The report includes CEO and CFO certifications pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[203](index=203&type=chunk) - Inline XBRL Instance, Taxonomy, and other related documents are filed as exhibits[203](index=203&type=chunk)

Exhibit 99.1 GeneDx Reports First Quarter 2024 Financial Results and Business Highlights Reported first quarter 2024 revenue from continuing operations of $61.5M with 96% year-over-year growth of exome and genome test revenue 1 Expanded first quarter 2024 adjusted gross margins from continuing operations to 61% 2 Narrowed first quarter 2024 adjusted net loss to $8.5M and delivered 71% year-over-year cash burn reduction 2 Raised guidance to deliver between $235M and $245M in FY 2024 revenue and reiterate pat ...

Reported first quarter 2024 revenue from continuing operations1 of $61.5M with 96% year-over-year growth of exome and genome test revenue Expanded first quarter 2024 adjusted gross margins2 from continuing operations to 61% Narrowed first quarter 2024 adjusted net loss2 to $8.5M and delivered 71% year-over-year cash burn reduction Raised guidance to deliver between $235M and $245M in FY 2024 revenue and reiterate path to profitability in 2025 GeneDx to host conference call today at 4:30 p.m. ET STAMFORD, C ...

STAMFORD, Conn., April 23, 2024 (GLOBE NEWSWIRE) -- GeneDx (NASDAQ:WGS), a leader in delivering improved health outcomes through genomic insights, today announced a strategic partnership with Komodo Health, a premier healthcare technology company for the pharmaceutical industry. The new partnership will increase access to GeneDx's extensive de-identified rare disease data set, now available through Komodo Health's MapEnhance offering, including data from more than 500,000 exomes, enabling biopharma companie ...

STAMFORD, Conn., April 04, 2024 (GLOBE NEWSWIRE) -- GeneDx (NASDAQ:WGS), a leader in delivering improved health outcomes through genomic insights, today announced it will release financial results for the first quarter of 2024 after the market closes on Monday, April 29, 2024. Management will host a conference call that day to discuss first quarter 2024 financial and operating results at 4:30 p.m. Eastern Time.  Conference Call Details Investors interested in listening to the conference call are required to ...

A downtrend has been apparent in GeneDx Holdings Corp. (WGS) lately. While the stock has lost 20.5% over the past week, it could witness a trend reversal as a hammer chart pattern was formed in its last trading session. This could mean that the bulls have been able to counteract the bears to help the stock find support.The formation of a hammer pattern is considered a technical indication of nearing a bottom with likely subsiding of selling pressure. But this is not the only factor that makes a bullish case ...

STAMFORD, Conn., March 14, 2024 (GLOBE NEWSWIRE) -- GeneDx (NASDAQ:WGS), a leader in delivering improved health outcomes through genomic insights, today announced its scientific contributions at the 2024 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting. Across one platform presentation, an industry symposium and six poster presentations, including one selected as a "Rapid Fire Poster Session," an invitation-only presentation of the top 20 ACMG posters, GeneDx continu ...

STAMFORD, Conn., March 14, 2024 (GLOBE NEWSWIRE) -- GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced its scientific contributions at the 2024 American College of Medical Genetics and Genomics (ACMG) Annual Clinical Genetics Meeting. Across one platform presentation, an industry symposium and six poster presentations, including one selected as a “Rapid Fire Poster Session,” an invitation-only presentation of the top 20 ACMG posters, GeneDx contin ...