Core Viewpoint - Pomerantz LLP is investigating potential securities fraud and unlawful business practices involving Fulgent Genetics, Inc. and its officers or directors [1] Group 1: Investigation Details - The investigation is prompted by claims from investors of Fulgent Genetics, Inc. [1] - Investors are encouraged to contact Pomerantz LLP for more information regarding the investigation [1] Group 2: Recent Developments - On February 28, 2025, Fulgent disclosed receiving a civil investigative demand from the U.S. Department of Justice concerning potential false claims under the Uninsured Program [3] - Following this disclosure, Fulgent's stock price decreased by $0.41 per share, or 2.61%, closing at $15.28 per share on March 3, 2025 [3] Group 3: Firm Background - Pomerantz LLP is recognized as a leading firm in corporate, securities, and antitrust class litigation, with a history of over 85 years in the field [4] - The firm has successfully recovered numerous multimillion-dollar damages awards for victims of securities fraud and corporate misconduct [4]

Company Overview - Fulgent Genetics, Inc. is a biotechnology company that specializes in diagnostic and genetic laboratory testing services and develops pharmaceutical treatments for various diseases and medical conditions [3] Allegations and Investigations - Edelson Lechtzin LLP is investigating potential violations of federal securities laws involving Fulgent, stemming from allegations of providing potentially misleading business information to investors [1] - On February 28, 2025, Fulgent disclosed in its annual report that it received a civil investigative demand from the U.S. Department of Justice related to potential false claims submitted under the federal COVID-19 testing program for uninsured individuals [4] Market Reaction - Following the disclosure of the civil investigative demand, Fulgent's stock price declined by $0.41 per share, or approximately 2.61%, closing at $15.28 per share on March 3, 2025 [5]

Core Viewpoint - Fulgent Genetics, Inc. is under investigation for potential violations of federal securities laws and unlawful business practices, following a civil investigative demand from the U.S. Department of Justice regarding false claims submitted under the Uninsured Program [1][2]. Group 1: Company Investigation - Bragar Eagel & Squire, P.C. is investigating potential claims against Fulgent on behalf of its stockholders [1]. - The investigation is focused on whether Fulgent has engaged in unlawful business practices or violated federal securities laws [1]. - Following the disclosure of the civil investigative demand, Fulgent's stock price decreased by $0.41 per share, or 2.61%, closing at $15.28 per share [2]. Group 2: Legal Context - The civil investigative demand was received by Fulgent from the U.S. Department of Justice, indicating serious scrutiny regarding the company's claims under the Uninsured Program [2]. - The law firm Bragar Eagel & Squire, P.C. specializes in representing investors in complex litigation, which includes securities and derivative cases [4].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud and unlawful business practices involving Fulgent Genetics, Inc. and its officers or directors [1]. Group 1: Investigation Details - The investigation is initiated on behalf of investors of Fulgent Genetics, Inc. [1]. - Investors are encouraged to contact Pomerantz LLP for more information regarding the investigation [1]. Group 2: Recent Developments - On February 28, 2025, Fulgent disclosed a civil investigative demand from the U.S. Department of Justice concerning potential false claims under the Uninsured Program [3]. - Following this disclosure, Fulgent's stock price decreased by $0.41 per share, representing a 2.61% decline, closing at $15.28 per share on March 3, 2025 [3].

Core Viewpoint - Pomerantz LLP is investigating potential securities fraud and unlawful business practices involving Fulgent Genetics, Inc. and its officers or directors [1][2] Group 1: Investigation Details - Pomerantz LLP is representing investors of Fulgent Genetics, Inc. in an investigation regarding claims of securities fraud [1] - The investigation follows a civil investigative demand received by Fulgent from the U.S. Department of Justice concerning potential false claims under the Uninsured Program [2] - Following the disclosure of the civil investigative demand, Fulgent's stock price decreased by $0.41 per share, or 2.61%, closing at $15.28 per share on March 3, 2025 [2] Group 2: Company Background - Pomerantz LLP is recognized as a leading firm in corporate, securities, and antitrust class litigation, with a history of over 85 years in the field [3] - The firm has a track record of recovering multimillion-dollar damages for victims of securities fraud and corporate misconduct [3]

Group 1 - Wolf Haldenstein Adler Freeman & Herz LLP is investigating claims on behalf of investors of Fulgent Genetics, Inc. (NASDAQ: FLGT) [1] - The investigation focuses on whether Fulgent Genetics and certain officers/directors engaged in securities fraud [4] - On February 28, 2025, Fulgent disclosed in its Form 10-K that it received a civil investigative demand from the Department of Justice (DOJ) regarding potential false claims submitted under the Uninsured Program [4] Group 2 - Wolf Haldenstein has over 125 years of legal expertise in securities litigation and a proven track record of protecting the rights of investors [4]

Financial Data and Key Metrics Changes - Revenue in Q1 2025 totaled $73.5 million, down from $76.2 million in Q4 2024, with negligible revenue from COVID-19 testing [21] - GAAP gross margin was 38.6%, while non-GAAP gross margin was 41%, showing year-over-year improvement due to operational efficiencies [21][22] - Total GAAP operating expenses were $48.1 million, slightly up from $48 million in Q4 2024, with non-GAAP operating expenses remaining flat at $37.4 million [22] - Adjusted EBITDA loss for Q1 was approximately $2.9 million, an improvement from a loss of $3.2 million in Q1 2024 [23] - The company ended Q1 with approximately $814.6 million in cash, cash equivalents, restricted cash, and marketable securities [23] Business Line Data and Key Metrics Changes - Precision diagnostics revenue increased by $6.7 million or 17.8% year-over-year, while anatomic pathology revenue rose by $2.2 million or 9.5% year-over-year [13] - Biopharma services revenue grew by $1.4 million or 51.3% year-over-year, although it experienced a sequential decline of 33.7% due to contract timing [14] - The growth in precision diagnostics was driven by reproductive health services and expanded carrier screening, with new client wins contributing significantly [14][15] Market Data and Key Metrics Changes - The company is seeing significant usage from new VA hospitals and positive momentum from partnerships, particularly with Foundation Medicine [14][15] - The biopharma services business is expected to experience variability quarter-to-quarter, but the company anticipates continued demand due to improved product offerings [19] Company Strategy and Development Direction - The company is focused on expanding its laboratory services and therapeutic development pipeline, with ongoing clinical trials for candidates FID-seven and FID-twenty two [10][11] - Investments in digital pathology and AI are expected to enhance operational efficiency and quality [18] - The company is evaluating potential M&A opportunities to enhance its distribution network and technology deployment [37] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the fundamentals in 2025, with expectations for core revenue to reach approximately $310 million, representing a 10% year-over-year growth [24] - Non-GAAP gross margins are expected to slightly exceed 40% for the full year, with anticipated cash burn for therapeutics development around $25 million [26] - The company aims to manage spending while focusing on capital allocation to support growth initiatives [27] Other Important Information - The company has repurchased approximately 646,000 shares at a cost of $10.9 million since the beginning of 2025, with a total of $110.4 million spent since the inception of the repurchase program [23][27] - The SEC investigation concluded with no enforcement action recommended, resulting in a reversal of a previously accrued liability of $1 million [22] Q&A Session Summary Question: Why not raise the full year guidance despite good momentum? - Management prefers to be more comfortable before adjusting guidance, aiming for considerable changes rather than minor adjustments [30][31] Question: How much of Q1 results came from new accounts in precision diagnostics? - The strong performance was driven by both existing clients and new client wins, with ongoing onboarding processes for larger clients [32][34] Question: Expectations for stock buybacks and M&A potential in 2025? - The company is actively deploying capital for stock buybacks and evaluating M&A options to enhance distribution and technology [36][37] Question: Expected penetration rate for FID-one hundred seven and its market potential? - The initial focus is on head and neck cancer, with potential for broader applications post-trial [39] Question: Thoughts on capital deployment for expanding sales and marketing? - Sales and marketing expenses are expected to increase as the company hires new personnel across various divisions [41][42]

Group 1: Earnings Performance - Fulgent Genetics reported quarterly earnings of $0.04 per share, exceeding the Zacks Consensus Estimate of a loss of $0.19 per share, representing an earnings surprise of 121.05% [1] - The company has surpassed consensus EPS estimates for four consecutive quarters [2] - The revenue for the quarter ended March 2025 was $73.46 million, surpassing the Zacks Consensus Estimate by 2.76%, compared to $64.49 million in the same quarter last year [2] Group 2: Stock Performance and Outlook - Fulgent Genetics shares have declined approximately 6.6% since the beginning of the year, while the S&P 500 has decreased by 4.7% [3] - The company's future stock performance will largely depend on management's commentary during the earnings call and the earnings outlook [4][6] - The current consensus EPS estimate for the upcoming quarter is -$0.19 on revenues of $76.69 million, and for the current fiscal year, it is -$0.66 on revenues of $310.49 million [7] Group 3: Industry Context - The Medical Info Systems industry, to which Fulgent Genetics belongs, is currently ranked in the top 24% of over 250 Zacks industries, indicating a favorable outlook compared to lower-ranked industries [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Financial Data and Key Metrics Changes - Revenue in Q1 2025 totaled $73.5 million, down from $76.2 million in Q4 2024, with negligible revenue from COVID-19 testing [19] - GAAP gross margin was 38.6%, while non-GAAP gross margin was 41%, showing year-over-year improvement due to operational efficiencies [19] - Total GAAP operating expenses were $48.1 million, slightly up from $48 million in Q4 2024, while non-GAAP operating expenses remained flat at $37.4 million [20] - Adjusted EBITDA loss for Q1 was approximately $2.9 million, an improvement from a loss of $3.2 million in Q1 2024 [21] Business Line Data and Key Metrics Changes - Precision Diagnostics revenue increased by $6.7 million or 17.8% year-over-year, driven by reproductive health services and expanded carrier screening [12] - Anatomic Pathology revenue rose by $2.2 million or 9.5% year-over-year, while Biopharma Services revenue surged by $1.4 million or 51.3% year-over-year [12] - Sequentially, Precision Diagnostics was up 1.2%, Anatomic Pathology down approximately 3.9%, and Biopharma down 33.7% due to contract timing [12][13] Market Data and Key Metrics Changes - The company is gaining market share in precision diagnostics, particularly in reproductive health and hereditary cancer testing [13][14] - The biopharma services business is experiencing continued strength from existing clients and a deepening pipeline of opportunities, despite variability in quarterly performance [17] Company Strategy and Development Direction - The company is focused on expanding its laboratory services and therapeutic development pipeline, with ongoing clinical trials for candidates FID-seven and FID-twenty two [9][10] - Investments in digital pathology and AI are expected to enhance operational efficiency and quality [16] - The company is evaluating potential M&A opportunities to enhance its distribution network and technology deployment [35] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the core business's growth and the potential for new client wins in precision diagnostics [11][32] - The company reiterated its 2025 guidance, expecting core revenue of approximately $310 million, representing a 10% year-over-year growth [22] - Management is monitoring the regulatory environment regarding lab-developed tests, following a recent court ruling that may impact future regulations [18] Other Important Information - The company has repurchased approximately 646,000 shares at a cost of $10.9 million since the beginning of 2025, with a total of $110.4 million spent since the inception of the repurchase program [21][24] - The cash position remains strong, with approximately $814.6 million in cash and marketable securities at the end of Q1 [21] Q&A Session Summary Question: Why not raise the full-year guidance despite good momentum? - Management prefers to wait for more comfort before adjusting guidance, aiming for considerable changes rather than minor adjustments [27][28] Question: How much of Q1 results came from new accounts in Precision Diagnostics? - The strong performance was driven by both existing clients and new client wins, with ongoing onboarding processes for larger clients [30][32] Question: Expectations for capital deployment and M&A potential? - The company is actively engaging in stock buybacks and evaluating M&A opportunities to enhance its distribution network [34][35] Question: Expected penetration rate for FID-one hundred seven? - The initial focus is on EGFR positive patients, with potential for broader applications as trials progress [37] Question: Thoughts on expanding sales and marketing? - Sales and marketing expenditures are expected to ramp up, with hiring across various divisions to support growth [38][40] Question: Insights on Precision Diagnostics momentum and contributions from different tests? - The growth is primarily driven by Beacon's expanded carrier screening, while Nova is not significantly contributing at this time [52][53]

This presentation contains forward-looking statements, which are statements other than those of historical facts and which represent the estimates and expectations of Fulgent Genetics, Inc. (the "Company" or "Fulgent") about future events based on current views and assumptions. Examples of forward-looking statements made in this presentation include, among others, those related to long-term upside or value, management of risk, anticipated growth and positioning, addressable market estimates, the Company's m ...