Revenue Performance - Revenue decreased by $12.9 million, or 15%, from $84.7 million in the three months ended September 30, 2023, to $71.7 million in the same period of 2024[118]. - Revenue from laboratory services decreased by $11.5 million, or 5%, from $218.7 million in the nine months ended September 30, 2023, to $207.3 million in the same period of 2024[118]. - The decrease in revenue was attributed to a $21.0 million decline in COVID-19 testing services and a $10.5 million decrease in BioPharma services[118]. - Precision diagnostics revenue increased by $27.6 million, driven by growth in reproductive health services and specialized oncology tests[119]. - Revenue from non-U.S. sources increased by $0.3 million, or 6%, from $5.7 million in Q3 2023 to $6.0 million in Q3 2024, and increased by $3.6 million, or 25%, from $14.6 million in the nine months ended September 30, 2023, to $18.2 million in the nine months ended September 30, 2024[123]. Operating Performance - Operating loss for the three months ended September 30, 2024, was $(17.1) million compared to a profit of $0.2 million in the same period of 2023, representing a change of $(17.3) million[117]. - Total operating expenses rose by $4.2 million, or 11%, from $39.6 million in the three months ended September 30, 2023, to $43.9 million in the same period of 2024[117]. - The net loss attributable to Fulgent was $(14.6) million for the three months ended September 30, 2024, compared to a net loss of $(13.1) million in the same period of 2023, reflecting a change of $(1.5) million[117]. Research and Development - Research and development expenses increased by $1.8 million, or 18%, from $10.0 million in the three months ended September 30, 2023, to $11.8 million in the same period of 2024[117]. - Research and development expenses for therapeutic development increased by $2.2 million, or 87%, from $2.6 million in Q3 2023 to $4.8 million in Q3 2024, and increased by $7.3 million, or 95%, from $7.7 million in the nine months ended September 30, 2023, to $15.1 million in the nine months ended September 30, 2024[129]. - The company anticipates continued increases in research and development expenditures as it begins enrollment for the phase 2 study of FID-007 in Q2 2024, expecting to enroll approximately 40 patients by late 2025[129]. Cash Flow and Financial Position - Cash, cash equivalents, restricted cash, and marketable securities totaled $815.4 million as of September 30, 2024, down from $847.7 million as of December 31, 2023[140]. - Cash used in operating activities for the nine months ended September 30, 2024, was $4.0 million, a decrease from $12.1 million provided in the same period in 2023[146]. - Cash used in investing activities for the nine months ended September 30, 2024, was $30.9 million, primarily due to $374.2 million for purchases of marketable securities and $36.5 million for fixed assets[148]. - Cash used in financing activities for the nine months ended September 30, 2024, was $4.5 million, primarily related to $2.7 million for common stock withholding for employee tax obligations[150]. - The company does not expect to use any credit facilities for the foreseeable future due to a strong cash position as of September 30, 2024[151]. Expenses Overview - Consolidated cost of revenue decreased by $7.6 million, or 5%, from $139.5 million in the nine months ended September 30, 2023, to $131.9 million in the nine months ended September 30, 2024[125]. - Gross profit decreased by $13.1 million, or 33%, from $39.8 million in Q3 2023 to $26.8 million in Q3 2024, and decreased by $3.9 million, or 5%, from $79.2 million in the nine months ended September 30, 2023, to $75.4 million in the nine months ended September 30, 2024[127]. - Consolidated selling and marketing expenses decreased by $1.0 million, or 10%, from $10.2 million in Q3 2023 to $9.1 million in Q3 2024[130]. - Consolidated general and administrative expenses increased by $3.5 million, or 20%, from $17.5 million in Q3 2023 to $21.0 million in Q3 2024[133]. Tax and Other Income - The effective tax rates were 21% and 14% for the three and nine months ended September 30, 2024, respectively, compared to 296% and (42)% for the same periods in 2023[138]. - Other income, net, included interest income of $8.1 million and $23.2 million in Q3 2024, compared to $6.5 million and $15.8 million in Q3 2023, respectively[137]. Stock Repurchase Program - As of September 30, 2024, approximately $150.5 million remained available for future repurchases of common stock under the stock repurchase program[153]. - The stock repurchase program authorized in March 2022 amounts to $250.0 million with no expiration date[152].

Financial Performance - Total revenue for Q3 2024 was $71.7 million, with core revenue growing 9% year-over-year[1][2] - Revenue for the three months ended September 30, 2024, was $71,743,000, a decrease from $84,687,000 in the same period of 2023, representing a decline of approximately 15.2%[19] - Gross profit for the nine months ended September 30, 2024, was $75,366,000, down from $79,227,000 in 2023, reflecting a decrease of about 4.9%[19] - Operating loss for the three months ended September 30, 2024, was $(4,166,000), compared to an operating income of $214,000 in the same period of 2023[19] - Net loss attributable to Fulgent for the nine months ended September 30, 2024, was $(36,820,000), a slight improvement from $(39,676,000) in 2023, indicating a reduction of about 7.0%[18] - Non-GAAP operating loss for the nine months ended September 30, 2024, was $(17,737,000), compared to $(7,031,000) in 2023, indicating a worsening of about 152.5%[19] Expenses and Investments - Research and development expenses for the nine months ended September 30, 2024, increased to $36,703,000 from $29,488,000 in 2023, marking a rise of approximately 24.7%[19] - Total operating expenses for the three months ended September 30, 2024, were $43,850,000, up from $39,630,000 in the same period of 2023, representing an increase of approximately 10.0%[19] - Interest income for the nine months ended September 30, 2024, was $23,181,000, compared to $15,802,000 in 2023, reflecting an increase of about 46.5%[18] Assets and Equity - Cash, cash equivalents, and investments in marketable securities totaled $815.4 million as of September 30, 2024[2] - Total assets as of September 30, 2024, were $1,233.8 million, slightly down from $1,235.3 million at the end of 2023[15] - Total stockholders' equity increased to $1,134.9 million as of September 30, 2024, compared to $1,133.3 million at the end of 2023[15] Future Projections - The company expects full year 2024 core revenue to be approximately $280 million[5] - GAAP loss per share is projected to improve from approximately ($1.95) to ($1.70) for the full year 2024[5] Business Development - Laboratory Services showed sequential growth in all three areas of the business during the quarter[4] - The company is progressing its therapeutic candidate FID-022 through preclinical studies towards an Investigational New Drug application[4] - The company continues to focus on transforming into a fully integrated precision medicine company[9]

Company Overview - Fulgent Genetics, Inc. (FLGT) shares increased by 5.8% to close at $21.45, supported by higher trading volume compared to normal sessions, following a 4.1% decline over the past four weeks [1][2] Financial Performance Expectations - The company is anticipated to report a quarterly loss of $0.19 per share, reflecting a year-over-year change of +51.3%, with expected revenues of $71.42 million, down 15.7% from the previous year [3] - The Zacks Consensus Estimate for the third quarter earnings indicates a growth of 51.2%, with results scheduled for release on November 8, 2024 [2][3] Earnings Estimate Trends - The consensus EPS estimate for Fulgent Genetics has remained unchanged over the last 30 days, suggesting that stock price movements may not sustain without trends in earnings estimate revisions [4] - The stock currently holds a Zacks Rank of 3 (Hold), indicating a neutral outlook [4] Industry Context - Fulgent Genetics is part of the Zacks Medical Info Systems industry, where another company, SOPHiA GENETICS SA (SOPH), saw a 6.2% increase in its stock price, closing at $3.58, despite a -4.5% return over the past month [4]

Fulgent Genetics, Inc. (NASDAQ: FLGT ) is a laboratory services and therapeutic development company headquartered in El Monte, California. The laboratory services segment, which currently accounts for all of the company's revenue, strives to offer affordable diagnostic and genetic testing services I am a value investor with a concentrated portfolio, focusing on rare and exceptional buying opportunities. As a keen reader of Value Investing literature, I am well versed in the teachings of 'super investors' su ...

Group 1 - Fulgent Genetics, Inc. reported quarterly earnings of $0.15 per share, exceeding the Zacks Consensus Estimate of a loss of $0.31 per share, and compared to a loss of $0.08 per share a year ago, representing an earnings surprise of 148.39% [1] - The company posted revenues of $71.03 million for the quarter ended June 2024, surpassing the Zacks Consensus Estimate by 3.37%, and this is an increase from year-ago revenues of $67.85 million [2] - Fulgent Genetics has surpassed consensus EPS estimates three times over the last four quarters, indicating a positive trend in earnings performance [2] Group 2 - The stock has underperformed the market, losing about 18.5% since the beginning of the year, while the S&P 500 has gained 14.2% [3] - The current consensus EPS estimate for the coming quarter is -$0.24 on revenues of $71.57 million, and for the current fiscal year, it is -$1.03 on revenues of $279.75 million [7] - The Zacks Industry Rank for Medical Info Systems is currently in the bottom 43% of over 250 Zacks industries, suggesting that the industry outlook may negatively impact stock performance [8]

Financial Data and Key Metrics - Total GAAP operating expenses were $43.9 million for Q1 2024, down from $176.4 million in Q4 2023, primarily due to a one-time non-cash goodwill impairment charge in Q4 2023 [3] - Non-GAAP operating expenses totaled $32.4 million in Q1 2024, down from $45.1 million in Q4 2023 [3] - Non-GAAP operating margin increased by approximately 12 percentage points sequentially to minus 12.9%, driven by lower bad debt reserve and legal fees [3] - Adjusted EBITDA loss for Q1 2024 was $3.2 million, compared to a loss of $7.2 million in Q1 2023 [27] - The company ended Q1 2024 with approximately $846.2 million in cash, cash equivalents, and marketable securities [27] Business Line Data and Key Metrics - Core revenue for Q1 2024 was $63.2 million, up $500,000 year-over-year but down $3.3 million sequentially [24] - Precision diagnostics revenue increased by $9.5 million (34%) year-over-year and $2 million (6%) sequentially, driven by reproductive health and oncology [24] - Anatomic pathology revenue declined sequentially, attributed to timing issues in biopharma service contracts [24] - The company expects 10% sequential core revenue growth in Q2 2024, driven by momentum in precision diagnostics [24] - Gross margin excluding COVID-19 revenue and stock-based compensation increased from 28% in Q1 2023 to 36% in Q1 2024, with expectations to reach 40% or higher by Q2 2024 [16][43] Market Data and Key Metrics - The company is focusing on the OB-GYN market with the launch of its new NIPT test, KNOVA, which combines aneuploidy screening, deletion duplication screening, and de novo point mutations into one test [1] - The biopharma services revenue stream is tracking on plan for 2024, with efforts to expand existing relationships and forge new ones [2] - The company is expanding its biopharma sales team and building a robust product offering to address a large market for biopharma studies [2] Company Strategy and Industry Competition - The company is shifting focus to the OB-GYN market, hiring a new sales team with OB-GYN experience and launching the KNOVA NIPT test [1] - The therapeutic development business is progressing well, with the lead drug candidate FID-007 showing promising results in clinical trials for various cancers [23] - The company is developing next-generation antibody drug conjugates (ADCs) to address challenges in cancer treatment, with a focus on improving therapeutic windows and pharmacokinetics [38] - The company is investing in digital technology and AI to improve operational efficiency in anatomic pathology services [41] Management Commentary on Operating Environment and Future Outlook - Management is confident in the momentum of the business, particularly in precision diagnostics and reproductive health, and expects continued growth in these areas [24][40] - The company anticipates gross margins to improve to 40% or higher by Q2 2024, with further increases expected in Q3 and Q4 2024 [16][43] - Management reiterated the full-year 2024 core revenue guidance of $280 million, representing 7% year-over-year growth [56] - The company expects to end 2024 with approximately $800 million in cash, cash equivalents, and marketable securities, excluding stock repurchases or other expenditures [28] Other Important Information - The company is consolidating its Texas and New York operations into a new building outside Irving, Texas, to improve operational efficiency [41] - The company is investing in digital slide imaging and AI to enhance the quality and efficiency of its anatomic pathology services [41] - The company is expanding its oncology laboratories, with one in Alpharetta, Georgia, and another in Phoenix, Arizona, catering to pathologists and oncologists respectively [25] Q&A Session Summary Question: What gives confidence in the revenue ramp to hit the $280 million sales target for 2024? - The company is seeing momentum in precision diagnostics, gaining market share in reproductive health and oncology, and stabilizing the anatomic pathology business [30][59] Question: What are the implications of the finalized lab-developed test regulations for Fulgent? - The company believes the new regulations bode well for Fulgent, as existing products may be exempt from a full PMA process, and the company has the necessary quality systems in place to adhere to FDA guidelines [7][60] Question: Will the new NIPT offering require FDA 510(k) clearance? - The company believes its new NIPT test, KNOVA, will not require a full PMA process but will still adhere to FDA quality standards [11][12] Question: What is the investment plan for the OB-GYN market launch? - The company plans to ramp up to 20 new sales headcount by the end of 2024, focusing on a national rollout of the KNOVA NIPT test [49][66] Question: What is the outlook for the anatomic pathology business? - The company has revamped its go-to-market strategy and sales organization for anatomic pathology, with expectations of stabilization and growth in 2024 [53][70]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-37894 FULGENT GENETICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation ...

First Quarter 2024 Results: Note: 1) Core Revenue is revenue calculated in accordance with GAAP minus revenue from COVID-19 testing products and services including COVID-19 NGS testing revenue, each as calculated in accordance with GAAP. Non-GAAP income (loss), non-GAAP income (loss) per share, adjusted EBITDA income (loss), non-GAAP gross profit and margin, and non-GAAP operating income (loss) and margin, are described below under "Note Regarding Non-GAAP Financial Measures" and are reconciled to the most ...

Financial Data and Key Metrics Changes - Total revenue for Q4 2023 was $70 million, compared to $68 million in Q4 2022, with $4 million from COVID-19 testing [33] - Core revenue, excluding COVID-19 testing, was $66 million, exceeding guidance of $64 million and representing a 21% year-over-year growth [33][28] - Adjusted EBITDA loss for Q4 was $6.8 million, an improvement from a loss of $15.1 million in Q4 2022 [10] - The company ended Q4 with approximately $848 million in cash, cash equivalents, and marketable securities [81] Business Line Data and Key Metrics Changes - Precision diagnostics revenue for 2023 was $132 million, with a projected growth to over $173 million in 2024, indicating over 31% organic growth [97] - Anatomic pathology revenue for 2023 was $104.7 million, with a projected decline in 2024 due to pricing pressure and lower contract rates [36][20] - Bio pharma services revenue for 2023 was $25.4 million, with a significant decline anticipated in 2024 due to project terminations [36][20] Market Data and Key Metrics Changes - The company gained significant market share in carrier screening due to a major competitor exiting the market [106] - The sales pipeline for carrier screening is filling up with new opportunities, indicating a positive market response [106] Company Strategy and Development Direction - The company is focused on expanding its precision diagnostics and improving its anatomic pathology and bio pharma services through technology investments and sales team enhancements [21][98] - A new facility in Dallas is being developed to enhance operational capabilities, with an expected cash outlay of over $15 million [37] - The company aims to leverage its technology platform to drive growth in precision diagnostics while addressing challenges in anatomic pathology [95][98] Management Comments on Operating Environment and Future Outlook - Management expressed optimism about the core business's strength and growth momentum, particularly in precision diagnostics [13] - The company anticipates a core revenue growth of approximately 7% year-over-year for 2024, with a focus on managing expenses and improving margins [35][12] - Management acknowledged challenges in the bio pharma services segment but emphasized the strength of their capabilities [32] Other Important Information - A one-time non-cash goodwill impairment charge of $120 million was recorded due to a decline in market capitalization, but it does not affect cash position or future operations [80] - The company has restructured its reporting segments to better reflect its operations, now categorizing its business into laboratory services and therapeutic development [73] Q&A Session Summary Question: Expectations for expanded carrier screening - Management noted that expanded carrier screening is becoming standard care, and positive guideline changes could enhance reimbursement opportunities [15] Question: Strategy around COVID testing - Management confirmed that they have effectively exited the COVID testing business, with current revenue primarily from collections on past tests [17] Question: Revenue breakdown for 2023 and growth expectations - Management provided detailed revenue figures for 2023 and projected declines in anatomic pathology and bio pharma services, with growth expected in precision diagnostics [20][46] Question: Update on the national rollout for Fulgent oncology - Management reported significant momentum in the oncology division, with robust reimbursement secured for assays [62] Question: Capital deployment strategy - Management indicated a focus on potential acquisitions and investments in technology to enhance efficiency and expand distribution channels [91]

Our consolidated cost of revenue decreased by $67.3 million, or 27%, from $252.1 million in 2022 to $184.8 million in 2023. The decrease was primarily due to decreases of $32.1 million in consulting and outside labor costs for production, $25.9 million in reagent and supply expenses, $12.3 million in depreciation expenses, $5.3 million in shipping expenses, and $1.2 million in travel and meals expense and $2.9 million in facility expense, all related to decreased COVID-19 testing, and partially offset by an ...