Fulgent Genetics(FLGT)

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Fulgent Genetics(FLGT) - 2021 Q3 - Quarterly Report
2021-11-08 16:00
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 September 30, 2021 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) Delaware 81-2621304 (State or other juris ...
Fulgent Genetics(FLGT) - 2021 Q2 - Earnings Call Presentation
2021-08-10 08:31
Exhibit 99.2 iulgent Founded in 2011 | Located in Los Angeles, CA | NASDAQ FLGT Disclaimer 2 Forward-Looking Statements and Market Data 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") about future events based on current views and assumptions. Examples of forward-looking statements made in this presentation include, among others, those related its anti ...
Fulgent Genetics(FLGT) - 2021 Q2 - Earnings Call Transcript
2021-08-10 01:12
Fulgent Genetics, Inc. (NASDAQ:FLGT) Q2 2021 Earnings Conference Call August 9, 2021 4:30 PM ET Company Participants Nicole Borsje - Investor Relations Ming Hsieh - Chief Executive Officer Larry Weiss - Chief Medical Officer Brandon Perthuis - Chief Commercial Officer Paul Kim - Chief Financial Officer Conference Call Participants Kevin DeGeeter - Oppenheimer Steven Mah - Piper Sandler Katie Tryhane - Crédit Suisse Operator Good day, and welcome to the Fulgent Genetics 2Q 2021 Earnings Conference Call. At t ...
Fulgent Genetics(FLGT) - 2021 Q2 - Quarterly Report
2021-08-09 16:00
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 June 30, 2021 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) Delaware 81-2621304 (State or other jurisdicti ...
Fulgent Genetics(FLGT) - 2021 Q1 - Earnings Call Transcript
2021-05-07 02:24
Fulgent Genetics, Inc. (NASDAQ:FLGT) Q1 2021 Earnings Conference Call May 6, 2021 4:30 PM ET Company Participants Nicole Borsje - The Blueshirt Group Ming Hsieh - Chairman, CEO & President Brandon Perthuis - Chief Commercial Officer Paul Kim - CFO Conference Call Participants Poon Mah - Piper Sandler & Co. Susan Chor - Oppenheimer Katie Tryhane - Crédit Suisse Operator Good day, and welcome to the First Quarter 2021 Fulgent Genetics Earnings Call. At this time, I would like to turn the conference over to Ni ...
Fulgent Genetics(FLGT) - 2021 Q1 - Quarterly Report
2021-05-06 16:00
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, 2021 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) Delaware 81-2621304 (State or other jurisdict ...
Fulgent Genetics(FLGT) - 2020 Q4 - Annual Report
2021-03-07 16:00
PART I [Business](index=5&type=section&id=Item%201.%20Business) Fulgent Genetics offers comprehensive genetic and large-scale COVID-19 testing services, leveraging a proprietary platform for significant 2020 growth [Overview](index=5&type=section&id=Overview) The company provides comprehensive genetic and large-scale COVID-19 testing services, achieving dramatic growth in 2020 with 4.4 million billable tests - The company offers a broad genetic test menu with over **18,000 single-gene tests** and more than **900 panels**, covering over **5,700 genetic conditions**[14](index=14&type=chunk) - Since March 2020, Fulgent has offered COVID-19 testing services, processing orders for governmental bodies, municipalities, and large corporations, including operating testing sites for the County of Los Angeles and the New York City public school system[16](index=16&type=chunk) Billable Test Volume Growth | Year | Billable Tests Delivered | | :--- | :--- | | 2020 | 4.4 million | | 2019 | 59,000 | [Our Technology Platform and Solution](index=6&type=section&id=Our%20Technology%20Platform%20and%20Solution) Fulgent's proprietary technology platform integrates gene probes, algorithms, and LIMS, driving operational efficiencies and a low internal cost per test - The company's proprietary technology platform integrates proprietary gene probes, advanced data comparison and suppression algorithms, adaptive learning software, and integrated laboratory information management systems (LIMS)[25](index=25&type=chunk)[26](index=26&type=chunk)[28](index=28&type=chunk) 2020 Key Operating Metrics | Metric | Value | | :--- | :--- | | Average Internal Cost per Billable Test | ~$20 | | Average Price per Billable Test | ~$96 | [Our Genetic Tests and COVID-19 Tests](index=8&type=section&id=Our%20Genetic%20Tests%20and%20COVID-19%20Tests) The company offers diverse genetic tests, including single-gene and whole exome sequencing, alongside COVID-19 tests with FDA Emergency Use Authorization and at-home collection kits - Test offerings include single-gene tests, over **900 pre-established panels**, whole exome/genome sequencing, and specialized tests like Solid Tumor Molecular Profiling and Rapid Whole Genome for NICU/PICU patients[36](index=36&type=chunk)[37](index=37&type=chunk) - The company launched **'Picture Genetics' in 2019**, a patient-initiated genetic testing service advertised directly to consumers[36](index=36&type=chunk) - Fulgent received an **FDA Emergency Use Authorization (EUA)** for its RT-PCR-based COVID-19 test, which includes an at-home specimen collection service through Picture Genetics, with labs capable of thousands of samples per day and a **24-48 hour turnaround time**[39](index=39&type=chunk) [Our Customers](index=9&type=section&id=Our%20Customers) Fulgent's customer base expanded to include governmental bodies for COVID-19 testing, with the County of Los Angeles and San Bernardino County representing **28% and 10% of 2020 revenue**, respectively Customer Concentration (2020 Revenue) | Customer | Percentage of Total Revenue | | :--- | :--- | | County of Los Angeles | 28% | | San Bernardino County | 10% | - The company classifies customers into three payor types: Insurance, Institutional (hospitals, labs, government bodies, corporations), and Patients (direct pay)[43](index=43&type=chunk) [Competition](index=11&type=section&id=Competition) Fulgent competes with numerous molecular genetic testing and COVID-19 diagnostic providers, leveraging its broad content and pricing, despite facing larger, more established competitors - Principal competitors include Ambry Genetics, Baylor Genetics, GeneDx, Laboratory Corporation of America Holdings, Myriad Genetics, Inc., and Quest Diagnostics Incorporated[57](index=57&type=chunk) - Key competitive factors in the market include breadth of genetic content, test customization, price, quality of results, turnaround time, and reimbursement arrangements[59](index=59&type=chunk) [Regulation](index=12&type=section&id=Regulation) Operating in a heavily regulated environment, the company's CLIA-certified labs offer LDTs, facing potential FDA oversight, complex reimbursement rules, and stringent privacy and fraud laws - The company's laboratories in California and Texas are certified under the Clinical Laboratory Improvement Amendments (CLIA) and accredited by the College of American Pathologists (CAP)[69](index=69&type=chunk) - Fulgent's genetic tests are considered Laboratory Developed Tests (LDTs), historically not subject to FDA premarket review, but future regulation like the proposed VALID Act could change this[83](index=83&type=chunk)[85](index=85&type=chunk) - The company is subject to various fraud and abuse laws, including the federal Anti-Kickback Statute, the Stark Law, and the False Claims Act, which carry severe penalties for non-compliance[113](index=113&type=chunk)[118](index=118&type=chunk)[121](index=121&type=chunk) - Compliance with data privacy laws such as HIPAA, HITECH, the California Consumer Privacy Act (CCPA), and the EU's General Data Protection Regulation (GDPR) is critical to operations[98](index=98&type=chunk)[104](index=104&type=chunk)[107](index=107&type=chunk) [Risk Factors](index=23&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks from operational fluctuations, reliance on COVID-19 testing, intense competition, customer concentration, sole suppliers, evolving regulations, and stock price volatility [Business and Strategy Risks](index=24&type=section&id=Business%20and%20Strategy%20Risks) Key business risks include fluctuating operating results, reliance on temporary COVID-19 testing, a history of losses, intense competition, customer concentration, and sole supplier dependency - The expansion of the COVID-19 testing business has led to rapid growth but presents management challenges and is expected to decrease as vaccines become widely deployed[152](index=152&type=chunk)[156](index=156&type=chunk) - The company has a history of losses and may not be able to sustain the profitability achieved in 2020[157](index=157&type=chunk) - Revenue is concentrated, with two customers (County of Los Angeles and San Bernardino County) accounting for **28% and 10% of total revenue in 2020**, respectively[163](index=163&type=chunk) - The company relies on **Illumina as the sole supplier** for its next-generation sequencers and associated reagents, creating a significant supply chain risk[210](index=210&type=chunk) [Regulatory Risks](index=39&type=section&id=Regulatory%20Risks) Regulatory risks include potential FDA oversight of LDTs, the need to maintain CLIA and state licenses, and compliance with complex healthcare laws like PAMA, HIPAA, and anti-fraud statutes - Potential changes in FDA enforcement discretion for Laboratory Developed Tests (LDTs), including possible legislation like the VALID Act, could subject the company's tests to premarket clearance or approval, increasing costs and delaying market access[252](index=252&type=chunk)[257](index=257&type=chunk) - Failure to comply with federal (CLIA) and state laboratory licensing requirements could result in the loss of ability to perform tests and significant business disruption[264](index=264&type=chunk)[270](index=270&type=chunk) - The marketing of COVID-19 tests under an Emergency Use Authorization (EUA) is subject to specific limitations, and the EUA can be terminated or revoked by the government[298](index=298&type=chunk)[300](index=300&type=chunk) - Changes in healthcare policy, such as the Affordable Care Act (ACA) and the Protecting Access to Medicare Act (PAMA), could negatively impact reimbursement rates and financial results[286](index=286&type=chunk)[288](index=288&type=chunk) [Intellectual Property Risks](index=47&type=section&id=Intellectual%20Property%20Risks) Intellectual property risks stem from reliance on trade secrets over patents, which may offer inadequate protection, and the potential for costly third-party infringement litigation - The company primarily relies on trade secret protection rather than patents, which may not be effective if confidential information is disclosed or independently developed by competitors[316](index=316&type=chunk)[317](index=317&type=chunk) - The company faces the risk of litigation from third parties claiming infringement of their intellectual property, which could result in substantial damages and prevent the sale of its tests[320](index=320&type=chunk)[321](index=321&type=chunk) [Common Stock Risks](index=50&type=section&id=Common%20Stock%20Risks) Common stock risks include high price volatility, limited liquidity due to concentrated ownership (CEO owning **28%**), and no anticipated dividends, with returns dependent on stock price appreciation - The trading price of the company's common stock has been and may continue to be highly volatile[334](index=334&type=chunk) - As of December 31, 2020, executive officers, directors, and 5%+ beneficial owners collectively owned approximately **32%** of the company's voting equity, with the founder and CEO alone owning **28%**, allowing for significant control over stockholder matters[338](index=338&type=chunk) - The company does not intend to pay dividends in the foreseeable future, limiting investor returns to potential stock price appreciation[343](index=343&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=54&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Fulgent Genetics' common stock trades on Nasdaq under 'FLGT' since 2016, with no anticipated dividends, and proceeds from equity offerings funding operations and a joint venture - The company's common stock has been listed on the Nasdaq Global Market under the symbol **"FLGT" since September 29, 2016**[366](index=366&type=chunk) - The company does not anticipate paying any cash dividends in the foreseeable future, planning to retain future earnings to finance business growth[370](index=370&type=chunk) - The company has raised significant capital through multiple equity offerings, including its **2016 IPO** and several equity distribution agreements and underwritten offerings in **2019 and 2020**[372](index=372&type=chunk)[374](index=374&type=chunk)[375](index=375&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=56&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Fulgent's 2020 financial performance was transformed by COVID-19 testing, with revenue surging to **$421.7 million**, net income of **$214.3 million**, and significantly strengthened liquidity from operations and equity offerings [Results of Operations](index=62&type=section&id=Results%20of%20Operations) In 2020, revenue surged **1196% to $421.7 million** due to COVID-19 testing, driving gross profit up **1702% to $331.9 million** and resulting in a net income of **$214.3 million** Financial Performance Comparison (2020 vs. 2019) | Metric | 2020 | 2019 | % Change | | :--- | :--- | :--- | :--- | | Revenue | $421.7M | $32.5M | 1196% | | Gross Profit | $331.9M | $18.4M | 1702% | | Operating Income (Loss) | $290.2M | ($0.4M) | 67894% | | Net Income (Loss) | $214.3M | ($0.4M) | 52244% | | Billable Tests Delivered | 4.4M | 59K | 7373% | | Avg. Price per Test | $96 | $555 | (83)% | | Cost per Test | $20 | $241 | (92)% | - The dramatic increase in revenue was primarily due to the volume of COVID-19 tests, which have a lower price point than the company's traditional genetic tests, leading to a substantial decline in the average selling price per test[440](index=440&type=chunk)[441](index=441&type=chunk) - Cost of revenue increased primarily due to higher reagent and supply expenses (**$49.9 million**), consulting/labor (**$10.6 million**), and personnel costs (**$8.1 million**) needed to support the massive increase in test volume[445](index=445&type=chunk) [Liquidity and Capital Resources](index=64&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2020, the company reported a strong liquidity position with **$87.4 million** in cash and **$344.4 million** in marketable securities, driven by operations and equity offerings Cash and Marketable Securities (Year-End, million) | Item | Dec 31, 2020 | Dec 31, 2019 | | :--- | :--- | :--- | | Cash and Cash Equivalents | $87.4 | $12.0 | | Marketable Securities | $344.4 | $58.3 | Summary of Cash Flows (Year Ended Dec 31, million) | Activity | 2020 | 2019 | | :--- | :--- | :--- | | Net Cash from Operations | $140.6 | $5.5 | | Net Cash used in Investing | ($326.4) | ($29.0) | | Net Cash from Financing | $261.3 | $28.8 | - The company raised a total of **$261.3 million** from financing activities in 2020, primarily through sales of common stock via various equity distribution agreements[476](index=476&type=chunk) [Controls and Procedures](index=69&type=section&id=Item%209A.%20Controls%20and%20Procedures) As of December 31, 2020, management concluded that the company's disclosure controls and internal control over financial reporting were effective, with no material changes reported - Management concluded that the company's disclosure controls and procedures were **effective as of December 31, 2020**[498](index=498&type=chunk) - Management concluded that the company's internal control over financial reporting was **effective as of December 31, 2020**, based on the COSO 2013 framework[499](index=499&type=chunk) PART III [Directors, Executive Officers, Corporate Governance, Executive Compensation, and Other Matters](index=70&type=section&id=Items%2010-14) Information for Items 10-14, covering directors, executive officers, corporate governance, compensation, security ownership, and related transactions, is incorporated by reference from the 2021 proxy statement - Information regarding Directors, Executive Officers, Corporate Governance (Item 10), Executive Compensation (Item 11), Security Ownership (Item 12), Certain Relationships and Related Transactions (Item 13), and Principal Accounting Fees and Services (Item 14) is incorporated by reference from the registrant's definitive proxy statement for its 2021 annual meeting of stockholders[506](index=506&type=chunk)[507](index=507&type=chunk)[508](index=508&type=chunk)[509](index=509&type=chunk)[510](index=510&type=chunk) PART IV [Exhibits, Financial Statement Schedules](index=71&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) The consolidated financial statements are filed with this report, with other schedules omitted, and an index of all 10-K exhibits is included - The consolidated financial statements are filed with this report, and all other financial statement schedules have been omitted[514](index=514&type=chunk) [Financial Statements](index=77&type=section&id=Financial%20Statements) Audited consolidated financial statements for 2020 and 2019 show dramatic financial improvement, with total assets reaching **$700.5 million**, net income of **$214.3 million**, and diluted EPS of **$8.91** in 2020 Consolidated Balance Sheet Data (in thousands) | Account | Dec 31, 2020 | Dec 31, 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $87,426 | $11,965 | | Marketable securities | $344,443 | $58,251 | | Trade accounts receivable, net | $183,857 | $6,555 | | **Total Assets** | **$700,461** | **$88,756** | | **Liabilities** | | | | Accounts payable | $26,488 | $1,581 | | Income tax payable | $53,319 | $24 | | **Total Liabilities** | **$131,074** | **$5,979** | | **Stockholders' Equity** | **$569,387** | **$82,777** | Consolidated Statement of Operations Data (in thousands) | Account | 2020 | 2019 | | :--- | :--- | :--- | | Revenue | $421,712 | $32,528 | | Gross Profit | $331,905 | $18,421 | | Operating Income (Loss) | $290,158 | ($428) | | Net Income (Loss) | $214,310 | ($411) | | Diluted EPS | $8.91 | ($0.02) | - The company's revenue is disaggregated by payor type, with Insurance (**$257.6 million**) and Institutional (**$163.1 million**) customers being the primary sources of revenue in 2020[620](index=620&type=chunk)
Fulgent Genetics(FLGT) - 2020 Q4 - Earnings Call Transcript
2021-03-05 00:48
Financial Data and Key Metrics Changes - The company reported fourth quarter revenue of $295 million, which is almost three times the revenue generated in the third quarter and more than 35 times the fourth quarter revenue of the previous year [11][47] - Non-GAAP income exceeded $6 per share in the fourth quarter and more than $9 per share for the full year, with $105.5 million in free cash flow [12][54] - Full year 2020 revenues totaled $422 million, up almost 1,200% year-over-year, with operating income of $290 million compared to an operating loss of $428,000 the previous year [54][55] Business Line Data and Key Metrics Changes - The company performed over 3 million tests in the fourth quarter and over 4.4 million tests for the year, compared to about 60,000 tests in all of 2019 [11][48] - The non-COVID-19 business grew approximately 43% year-over-year in the fourth quarter, with core business revenues reaching almost $37 million [24][48] - Next Generation Sequencing (NGS) tests volume increased from 59,000 in 2019 to 72,000 in 2020, with expectations for NGS revenue to grow above 92% year-over-year to $70 million in 2021 [18][60] Market Data and Key Metrics Changes - The company was recognized as the number one provider of COVID-19 tests in California, processing the highest volume of tests with over 90% of results returned within 24 hours [14] - The customer base diversified significantly, with direct agreements established with 11 counties and various large corporations, sports teams, and nursing homes [28][30] - The company expects to generate approximately $800 million in revenues for 2021, representing a growth of 90% year-over-year [58] Company Strategy and Development Direction - The company plans to invest in sales and marketing initiatives and explore international expansion, viewing M&A as a potential avenue for growth [20][63] - The company aims to leverage its technology platform to address larger markets and enhance its competitive position [19][22] - The introduction of new software products, such as the vaccine management platform and community testing software, is part of the strategy to expand service offerings [43][44] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's market share and positioning for 2021, despite potential fluctuations in COVID testing demand [67][68] - The company anticipates a more diverse mix of revenue drivers in 2021, with significant growth expected from both COVID-19 and non-COVID-19 testing [55][56] - Management highlighted the importance of maintaining high-quality service and turnaround times to differentiate from competitors [95][96] Other Important Information - The company donated $1 million to the National Academy of Engineering to support COVID-19 engineering solutions and made an initial donation of $250,000 to USC for cancer research initiatives [21][22] - The company ended the fourth quarter with $432 million in cash and cash equivalents, with a strong capital structure and minimal dilution to shareholders [53][63] Q&A Session Summary Question: What is the trend of revenue concentration in California for 2021? - Management acknowledged that a significant portion of revenue comes from California but emphasized ongoing diversification efforts within the state and other regions [65][66] Question: Can you provide details on the Department of Homeland Security contract? - The company is one of four labs in a $2 billion contract, with the ability to handle a meaningful portion of the testing demand driven by government task orders [70][72] Question: How does the company view the market for COVID variant characterization? - Management expressed optimism about the market for NGS testing related to COVID variants, highlighting the company's capabilities and existing contracts [75][76] Question: What is the expected revenue mix for 2022? - Management indicated that both NGS and non-NGS testing will contribute to revenue, with a focus on expanding NGS capabilities [90][91]
Fulgent Genetics(FLGT) - 2020 Q3 - Earnings Call Transcript
2020-11-10 04:01
Fulgent Genetics, Inc. (NASDAQ:FLGT) Q3 2020 Results Earnings Conference Call November 9, 2020 4:30 PM ET Company Participants Nicole Borsje - Head, Investor Relations Ming Hsieh - Chief Executive Officer Paul Kim - Chief Financial Officer Brandon Perthuis - Chief Commercial Officer Conference Call Participants Rachel Vatnsdal - Piper Sandler Erin Wright - Credit Suisse Kevin DeGeeter - Oppenheimer Operator Ladies and gentlemen, thank you for standing by. And welcome to the Q3 2020 Fulgent Genetics Earnings ...
Fulgent Genetics(FLGT) - 2020 Q3 - Quarterly Report
2020-11-09 21:24
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 September 30, 2020 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) Delaware 81-2621304 ( State or other juri ...