Fulgent Genetics Inc
For the period ended Dec 31, 2024. Filed Feb 28, 2025.
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FY2024 · Filed Feb 28, 2025
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Notes to Consolidated Financial Statements
Note 1. Overview and Basis of Presentation
The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States, or U.S. GAAP. These financial statements include the assets, liabilities, revenues and expenses of all subsidiaries and entities in which the Company has a controlling financial interest or is deemed to be the primary beneficiary. In determining whether the Company is the primary beneficiary of an entity, the Company applies a qualitative approach that determines whether it has both (i) the power to direct the economically significant activities of the entity and (ii) the obligation to absorb losses of, or the right to receive benefits from, the entity that could potentially be significant to that entity. The Company uses the equity method to account for its investments in entities that it does not control, but in which it has the ability to exercise significant influence over operating and financial policies. All intercompany accounts and transactions are eliminated from the accompanying consolidated financial statements.
Nature of the Business
Fulgent Genetics, Inc., together with its subsidiaries and affiliated professional corporations, or PCs (collectively referred to as the Company, unless otherwise noted or the context otherwise requires), is a technology-based company with a well-established laboratory services business and a therapeutic development business. Its laboratory services business includes technical laboratory and testing services and professional interpretation of laboratory results by licensed physicians. Its therapeutic development business is focused on developing drug candidates for treating a broad range of cancers using a novel nanoencapsulation and targeted therapy platform designed to improve the therapeutic window and pharmacokinetic profile of new and existing cancer drugs. The Company aims to transform from a genomic diagnostic business into a fully integrated precision medicine company.
Note 2. Summary of Significant Accounting Policies
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make certain estimates, judgments and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements, as well as the reported amounts of revenue and expenses during the reporting periods. These estimates, judgments, and assumptions are based on historical data and experience available at the date of the accompanying consolidated financial statements, as well as various other factors management believes to be reasonable under the circumstances. The Company’s estimates and assumptions may evolve as conditions change. Actual results could differ significantly from these estimates.
On an on-going basis, management evaluates its estimates, primarily those related to: (i) revenue recognition criteria, (ii) accounts receivable and allowances for credit losses, (iii) the useful lives of fixed assets and intangible assets, (iv) estimates of tax liabilities, (v) valuation of goodwill and indefinite-lived intangible assets at time of acquisition and on a recurring basis, and (vi) valuation of investments.
Principles of Consolidation
The accompanying consolidated financial statements include the accounts of the Company. All intercompany transactions and balances have been eliminated in consolidation.
Cash and Cash Equivalents
The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents. Cash and cash equivalents include cash held in banks and money market accounts. Cash equivalents are stated at fair value.
Restricted Cash
Restricted cash consists of legally restricted deposits held in conjunction with a lease contract the Company entered into with a third-party landlord. A bank guarantee equivalent to six months of gross rent plus tax with an expiry date three months post the lease expiry is required under the lease contract, and the lease contract will expire in March 2034. Restricted deposit is recorded in other long-term assets in the Company’s Consolidated Balance Sheets as the balance is not expected to be released to cash within the next
12 months. As of December 31, 2024, the Company had restricted cash of$0.1 million. The Company didnot have restricted cash as of December 31, 2023.
Marketable Securities
All marketable debt securities, which consist of U.S. government and agency debt securities, U.S. treasury bills, corporate debt securities, municipal bonds, and Yankee debt securities issued by foreign governments or entities and denominated in U.S. dollars have been classified as “available-for-sale,” and are carried at fair value. Net unrealized gains and losses, net of any related tax effects, are excluded from earnings and are included in other comprehensive income (loss) and reported as a separate component of stockholders’ equity until realized. Realized gains and losses on marketable debt securities are included in interest income, in the accompanying Consolidated Statements of Operations. The cost of any marketable debt securities sold is based on the specific-identification method. The amortized cost of marketable debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Interest on marketable debt securities is included in interest income. In accordance with the Company’s investment policy, management invests to diversify credit risk and only invests in securities with high credit quality, including U.S. government securities.
The Company’s investments in marketable equity securities are measured at fair value with the related gains and losses, realized and unrealized, recognized in interest income, in the accompanying Consolidated Statements of Operations. The cost of any marketable equity securities sold is based on the specific-identification method.
For available-for-sale debt securities, in an unrealized loss, the Company determines whether a credit loss exists. The credit loss is estimated by considering available information relevant to the collectability of the security and information about past events, current conditions, and reasonable and supportable forecasts. The Company compares the present value of cash flows expected to be collected from the security with the amortized cost basis of the security. If the present value of cash flows to be collected is less than the amortized basis of the security, a credit loss exists, and an allowance for credit losses is recorded for the credit loss, limited by the amount of unrealized loss. Changes in the allowance are recorded in the period of changes as credit loss expense. If the Company has an intent to sell, or if it is more likely than not that the Company will be required to sell a debt security in an unrealized loss position before recovery of its amortized cost basis, the Company will write down the security to its fair value and record the corresponding charge as a component of other income, net.
Trade Accounts Receivable and Allowance for Credit Losses
Trade accounts receivable are stated at the amount the Company expects to collect. The Company maintains an allowance for credit losses for expected uncollectible trade accounts receivable, which is recorded as an offset to trade accounts receivable, and changes in allowance for credit losses are classified as a general and administrative expense in the accompanying Consolidated Statements of Operations. The Company assesses collectability by reviewing trade accounts receivable on a collective basis where similar risk characteristics exist and on an individual basis when it identifies specific customers that have deterioration in credit quality such that they may no longer share similar risk characteristics with the other receivables. In determining the amount of the allowance for credit losses, the Company uses a loss rate model or probability-of-default and loss given default model. Following the loss rate method, expected credit losses are determined based on an estimated historical loss rate. The probability of default method allows the ability to define a point of default and measure credit losses for receivables that have reached the point of default for purposes of calculating the allowance for credit losses. Loss given default represents the likelihood that a receivable that has reached the point of default will not be collected in full. The Company updates its loss rate and factors annually to incorporate the most recent historical data and adjusts the quantitative portion of the reserve through its qualitative reserve overlay. The Company looks at qualitative factors such as general economic conditions in determining expected credit losses.
A roll-forward of the activity in the Company’s allowance for credit losses is as follows:
| 2024 | 2023 | 2022 | |
|---|---|---|---|
| (in thousands) | |||
| Allowance for credit losses at beginning of year | $25,226 | $41,205 | $11,217 |
| Current period (gain) provision | (1,730) | (880) | 32,596 |
| Write-downs | (11,155) | (15,099) | (2,608) |
| Recoveries of amounts previously charged off | 8,117 | — | — |
| Allowance for credit losses at end of year | $20,458 | $25,226 | $41,205 |
Preferred Stock Investment
The redeemable preferred stock investment of $20.4 million as of December 31, 2023, represents the fair value of the 7.3 million shares of preferred stock of a privately-held, Cayman Islands company, Laboratory for Advanced Medicine, Inc., or LAMH, doing business as “Helio Health” that the Company purchased in July 2021. Helio Health is an AI-biotechnology company developing blood-based early cancer detection tests, and the Company expected to gain access to an emerging liquid biopsy testing technology, through this strategic partnership. As the preferred stock had the option to be redeemed, the investment was initially recorded as available-for-sale debt securities with changes in fair value recorded in other comprehensive income (loss).
On June 19, 2024, the Board of Directors of LAMH approved to spin out certain U.S.-based laboratory and development operations into a separate, privately-held Delaware corporation, Helio Genomics, Inc., or Helio Genomics. The Company received 7.3 million shares of preferred stock of Helio Genomics in connection with this spin-out.
Post spin-out, Helio Genomics amended and restated its certificate of incorporation on July 25, 2024, which resulted in a change in stockholder’s rights where the Company no longer holds the right to redeem its preferred stock of Helio Genomics. As a result, the Company reclassified $0.4 million unrealized gain out of accumulated other comprehensive income (loss) to net income (loss) in the consolidated financial statements. The Company elected to record its preferred stock investment in Helio Genomics under the measurement alternative in accordance with ASC 321, defined as cost less impairment, adjusted for subsequent observable price changes and are periodically assessed for impairment when events or circumstances indicate that a decline in value may have occurred. As of July 25, 2024, the preferred stock investment carrying value of $9.9 million was recorded as other long-term assets in the Consolidated Balance Sheets. No impairment loss was recorded as of December 31, 2024.
Post spin-out, the Company retained the original right to redeem its LAMH preferred stock. As the preferred stock had the option to be redeemed, the investment was recorded as available-for-sale debt securities with changes in fair value recorded in other comprehensive income (loss). The Company considered a number of factors including, but not limited to: (i) the extent to which the fair value of the investment is less than its amortized cost; (ii) the financial condition and near-term prospects of the investee, and (iii) general market conditions. As a result, the Company recognized a $10.1 million credit loss during the year ended December 31, 2024, recorded as impairment of available-for-sale debt securities in the Consolidated Statements of Operations.
The roll-forward for the allowance for credit losses related to theavailable-for-sale debt securities is as follows:
| 2024 | 2023 | 2022 | |
|---|---|---|---|
| (in thousands) | |||
| Allowance for credit losses at beginning of year | $— | $— | $— |
| Current period provision | 10,073 | — | — |
| Write-downs | (10,073) | — | — |
| Allowance for credit losses at end of year | $— | $— | $— |
Business Combinations
The Company uses the acquisition method of accounting and allocates the fair value of purchase consideration to the assets acquired and liabilities assumed from an acquiree based on their respective fair values as of the acquisition date. The excess of the fair value of purchase consideration over the fair value of these assets acquired and liabilities assumed is recorded as goodwill. When determining the fair values of assets acquired and liabilities assumed, management makes significant estimates and assumptions, especially with respect to intangible assets. Critical estimates in valuing intangible assets include, but are not limited to, expected future cash flows, which includes consideration of future growth and margins, future changes in technology, expected cost and time to develop in-process research and development, brand awareness and discount rates. Fair value estimates are based on the assumptions that management believes a market participant would use in pricing the asset or liability.
Fixed Assets
Fixed assets are recorded at cost, net of accumulated depreciation and amortization. Depreciation is recorded using the straight-line method over the estimated useful lives of the assets. Leasehold improvements are capitalized and amortized over the shorter of their expected lives or the applicable lease term, including renewal options, if available. Major replacements and improvements are capitalized, while general repairs and maintenance are expensed as incurred. See Note 5, Fixed Assets, for useful lives for each major class of fixed assets.
Finite-Lived Intangible assets
Intangible assets, unless determined to be indefinite-lived, are amortized over their estimated useful lives. The Company amortizes intangible assets on a straight-line basis with definite lives generally over periods ranging from three to 14 years. See Note 17, Goodwill and Intangible Assets, for details of intangible assets.
Impairment of Long-Lived Assets
The Company evaluates the carrying amount of its long-lived assets whenever events or changes in circumstances indicate that the assets may not be recoverable. An impairment loss would be recognized when estimated future cash flows expected to result from the use of an asset and its eventual disposition is less than the carrying amount of the asset.
Goodwill and Indefinite-lived Intangibles
In-process research & development, or IPR&D, costs are considered to be indefinite-lived until the completion or abandonment of the associated research and development efforts. If and when development is complete, the associated assets would be deemed finite-lived and would then be amortized based on their respective estimated useful lives at that point in time.
The Company assesses goodwill and indefinite-lived intangibles for impairment on an annual basis and between annual tests if an event occurs or circumstances change that would more likely than not reduce the fair value of a reporting unit below its carrying amount. The Company may choose to bypass a qualitative assessment of impairment for any reporting unit and proceed directly to performing a quantitative assessment. An impairment loss would be recognized for the amount by which the reporting unit's carrying amount exceeds its fair value.
The Company’s quantitative assessment includes estimating the fair value of each reporting unit and comparing it to its carrying value. The Company estimates the fair value of reporting units using both income-based and market-based valuation methods and typically engages a third-party appraisal firm to assist with the valuation. The estimated fair value for each reporting unit is determined based upon the range of estimated values developed from the income and market-based methods. If the estimated fair value of a reporting unit exceeds its carrying value, the goodwill is not impaired, and no further review is required.
The income-based fair value methodology is based on a reporting unit’s forecasted future cash flows that are discounted to the present value using the reporting unit’s weighted-average cost of capital, or WACC. Under the income-based approach, it requires management’s assumptions and judgments regarding economic conditions in the markets in which the company operates and conditions in the capital markets, many of which are outside of management’s control. The market-based fair value methodology looks at the guideline public company valuation method to determine the prices of comparable public companies and looks at merger and acquisition methods, similar businesses that were sold recently, to estimate the value of the reporting units. Under the market-based approach, judgment is required in evaluating market multiples and recent transactions.
The Company performed an annual goodwill and intangible asset impairment test on December 31, 2024, and elected to bypass the optional qualitative test and perform the quantitative assessments for its therapeutic development reporting units, which includes an indefinite-lived intangible asset.
Reagents and Supplies
The Company maintains reagents and other consumables primarily used in testing which are valued at the lower of cost or net realizable value. Cost is determined using actual costs on a first-in, first-out basis. The reagents and other consumables were included in other current assets in the accompanying Consolidated Balance Sheets.
Fair Value of Financial Instruments
The Company’s financial instruments consist principally of cash and cash equivalents, marketable securities, trade accounts receivable, restricted cash, a redeemable preferred stock investment, preferred stock investments, accounts payable, and accrued liabilities. The carrying amounts of certain of these financial instruments, including cash and cash equivalents, accounts receivable, accounts payable, and accrued liabilities approximate fair value due to their short maturities. Fair value of marketable securities, the redeemable preferred stock investment, and the preferred stock investments is disclosed in Note 4, Fair Value Measurements, to the accompanying consolidated financial statements.
Concentrations of Credit Risk, Customers and Suppliers
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents, trade accounts receivable, and marketable securities. As of December 31, 2024, substantially all of the Company’s cash and cash equivalents were deposited in accounts at financial institutions, and amounts may exceed federally insured limits. Management believes that the Company is not exposed to significant credit risk due to the financial strength of the depository institutions in which its cash and cash equivalents are held.
In certain periods, a small number of customers has accounted for a significant portion of the Company’s revenue. For the laboratory services segment, aggregating customers under common control, one customer comprised of$62.6 million or 22% of total revenue in the year ended December 31, 2024, and the same customer comprised of$35.7 million or 12% of total revenue in the year ended December 31, 2023. A different customer comprised of$115.6 million or 19% of total revenue in the year ended December 31, 2022. One customer comprised 15% of total accounts receivable, net, as of December 31, 2024, and the same customer comprised 13% of total accounts receivable, net, as of December 31, 2023. For the therapeutic development segment, the Company doesn't have customers or revenue as it does not have any commercialized or approved drug candidates.
The Company’s therapeutic development business relies on ANP Technologies, Inc. for certain laboratory services, equipment, tools, and drug intermediates in connection with research and development efforts. The Company also relies on a limited number of suppliers for certain laboratory substances used in the chemical reactions incorporated into its processes, referred to as reagents, as well as for the sequencers and various other equipment and materials it uses in its laboratory operations. In particular, the Company relies on a sole supplier for the next generation sequencers and associated reagents it uses to perform its genetic tests and as the sole provider of maintenance and repair services for these sequencers. The Company’s laboratory operations would be interrupted if it encountered delays or difficulties securing these reagents, sequencers, other equipment or materials or maintenance and repair services, which could occur for a variety of reasons, including if the Company needs a replacement or temporary substitute for any of its limited or sole suppliers and is not able to locate and make arrangements with an acceptable replacement or temporary substitute. The Company’sdevelopment efforts could also be delayed or interrupted if it is unable to procure items needed for its therapeutic development activities. The Company believes there are currently only a few other manufacturers that are capable of supplying and servicing some of the equipment and other materials necessary for its laboratory operations, including sequencers and various associated reagents.
Leases
The Company determines if an arrangement is a lease at inception by evaluating whether the arrangement conveys the right to use an identified asset and whether the Company obtains substantially all of the economic benefits from and has the ability to direct the use of the asset. Operating and finance lease right-of-use assets, or ROU assets, short-term lease liabilities, and long-term lease liabilities are included in other long-term assets, accrued liabilities, and other long-term liabilities, respectively, in the accompanying Consolidated Balance Sheets.
Lease ROU assets represent the Company’s right to use an underlying asset for the lease term. Lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Lease ROU assets and liabilities are recognized at the commencement date based on the present value of lease payments over the lease term, including options to extend the lease when it is reasonably certain that the Company will exercise that option. The Company uses its incremental borrowing rate based on the information available at the commencement date, including inquiries with its bank, in determining the present value of lease payments when its leases do not provide an implicit or explicit rate. Lease ROU assets consist of initial measurement of lease liabilities, any lease payments made to lessor on or before the lease commencement date, minus any lease incentive received, and any initial direct costs incurred by the Company. Operating lease expense for lease payments is recognized on a straight-line basis over the lease term. For finance lease, ROU assets are amortized on a straight-line basis from the commencement date to the earlier of the end of useful life of the ROU assets or the end of the lease term. Amortization of ROU assets and interest on the lease liability for finance leases are included as charges to the accompanying Consolidated Statements of Operations.
Lease ROU assets and liabilities arising from business combinations are recognized and measured at the acquisition dates as if an acquired lease were a new lease at the date of acquisition using the Company’s incremental borrowing rate unless the discount rate is implicit in the lease. The Company elects to not to recognize assets or liabilities as of the acquisition dates for leases that, on the acquisition dates, have a remaining lease term of 12 months or less. The Company also retains the acquirees’ classification of the leases if there are no modifications as part of the business combinations.
The Company leased out space in buildings it owns to third-party tenants under noncancelable operating leases. The Company recognized lease payments as income over the lease terms on a straight-line basis and recognized variable lease payments as income in theperiod in which the changes in facts and circumstances on which the variable lease payments were based occurred. The net rental income was included in the other income, net, in the accompanying Consolidated Statements of Operations.
Software for Internal Use
The Company capitalizes certain costs incurred to purchase computer software for internal use. These costs include purchased software packages for Company use. Capitalized computer software costs are amortized over the estimated useful life of the computer software, which is generallyone to 10 years. Internally developed software costs are capitalized after management has committed to funding the project, it is probable that the project will be completed and the software will be used for its intended function. Costs that do not meet that criteria and costs incurred on projects in the preliminary and post-implementation phases are expensed as incurred.
Reportable Segment and Geographic Information
Reporting segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company’s chief operating decision maker is its Chief Executive Officer. The Company reports its business intwo segments, a laboratory services business and a therapeutic development business. For further financial information about these segments, including information for each of the last three fiscal years regarding revenue, operating income (loss), and other important information, see Note 7, Reportable Segment and Geographic Information.
Revenue Recognition
The Company generates revenue from sales of its testing services. The Company currently receives payments from primarily three different customer types: insurance payors, institutional customers, including hospitals, medical institutions, other laboratories, governmental bodies, municipalities, and large corporations, and patients who pay directly.
The Company recognizes revenue in an amount that reflects the consideration to which it expects to be entitled in exchange for the transfer of promised goods or services to its customers. To determine revenue recognition for contracts with customers, the Company performs the following steps described in ASC 606: (1) identifies the contract with the customer, or Step 1, (2) identifies the performance obligations in the contract, or Step 2, (3) determines the transaction price, or Step 3, (4) allocates the transaction price to the performance obligations in the contract, or Step 4, and (5) recognizes revenue when (or as) the entity satisfies a performance obligation, or Step 5.
The Company’s test results are primarily delivered electronically. The Company bills certain customers for shipping and handling fees incurred by the Company, and shipping and handling fees billed to customers are included in revenue, and such shipping and handling fees incurred are included in cost of revenue in the accompanying Consolidated Statements of Operations.
Performance Obligations
Institutional and Patient Direct Pay
The Company’s institutional contracts for its testing services typically have a single performance obligation to deliver testing services to the ordering facility or patient. In arrangements with institutions, including hospitals, medical institutions, other laboratories, governmental bodies, municipalities, and large corporations, and patients who pay directly, the transaction price is stated within the contract and is therefore fixed consideration. For most of the Company’s testing, the Company identified the institutions, including hospitals, medical institutions, other laboratories, governmental bodies, municipalities, and large corporations, and patients as the customer in Step 1 and have determined a contract exists with those customers in Step 1. As these contracts typically have a single performance obligation, no allocation of the transaction price is required in Step 4. Control over testing services is transferred to the Company’s ordering facility at a point in time. Specifically, the Company determined the customer obtains control of the promised service upon delivery of test results.
The Company enters into contracts with research institutions to perform testing and research services. Revenue is recognized as each individual test is completed, as the Company has a right to payment upon completion of each test. While the contract represents a single performance obligation to provide testing and research services, the revenue is recognized as the individual tests are completed and the results are delivered to the customer. Each completed test is considered a measurable event that indicates the transfer of control to the customer, at which point revenue is recognized. The Company regularly reviews its contracts and recognizes revenue in accordance with the completion of each test, based on the right to payment and the transfer of control.
Insurance
The Company’s insurance contracts for testing services typically have a single performance obligation to deliver testing services to the ordering facility or patient. For most of the Company’s insurance revenue, the Company identified the patient as the customer in Step 1 and determined a contract exists with the patient in Step 1. In arrangements with insurance patients, the transaction price is typically stated within the contract, however, the Company may accept payments from insurance payors that are less than the contractually stated price, therefore estimation of the transaction price is considered variable consideration. In developing the estimate of variable consideration, the Company utilizes the expected value method under a portfolio approach. As these contracts typically have a single performance obligation, no allocation of the transaction price is required in Step 4. Control over testing services is transferred to the Company’s ordering parties at a point in time. Specifically, the Company determined the customer obtains control of the promised service upon delivery of the test results.
Certain incremental costs pertaining to both insurance and institutional, such as commissions, are incurred in obtaining contracts. Contract costs are capitalized if the Company expects to recover them, and amortization of contract costs is classified in the general and administrative expense in the Consolidated Statements of Operations. Historically contract costs have not been significant to the financial statements.
Significant Judgments and Contract Estimates
Accounting for insurance contracts includes estimation of the transaction price, defined as the amount the Company expects to be entitled to receive in exchange for providing the services under the contract. Due to the Company’s out-of-network status with various insurance payors, estimation of the transaction price represents variable consideration.
In the absence of Medicare coverage, contractually established reimbursement rates or other coverage, we have concluded that our contracts include variable consideration because the amounts paid by Medicare or commercial health insurance carriers may be paid at less than our standard rates or not paid at all, with such differences considered implicit price concessions. Variable consideration attributable to these price concessions measured at the expected value using the “most likely amount” method under ASC 606. The amounts are determined by the historical average collection rates by test type taking into consideration the range of possible outcomes, the predictive value of our past experiences, the time period of when uncertainties expect to be resolved and the amount of consideration that is susceptible to factors outside of our influence, such as the judgment and actions of insurance payors. Such variable consideration is included in the transaction price only to the extent it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainties with respect to the amount are resolved. Variable consideration may be constrained and excluded from the transaction price in situations where there is no contractually agreed upon reimbursement coverage or in the absence of a predictable pattern and history of collectability with a payor.
The Company re-assesses its estimated transaction price at the end of each reporting period, including an assessment of whether the estimate variable consideration is constrained to the extent that is probable that a significant reversal of cumulative revenue will not occur once any uncertainty is resolved. The Company records any necessary adjustments in the current period’s revenue.$1.8 million and$23.0 million variable consideration was recognized as additional revenue in the years ended December 31, 2024 and 2023, respectively, that related to collections for COVID-19 tests completed in the prior period.
Contract Liabilities
Contract liabilities are recorded when the Company receives payment or bills prior to completing its obligation to transfer goods or services to a customer, and the Company subsequently recognizes contract liabilities as revenue in the period in which the applicable revenue recognition criteria, as described above, are met.
Customer Deposit
Customer depositin the accompanying Consolidated Balance Sheets consists of payments received from customers in excess of their outstanding trade accounts receivable balances. These deposits will be offset against future testing receivables or refunded to the customers.
Overhead Expenses
The Company allocates overhead expenses, such as facility, rent, and utilities, to cost of revenue and operating expense categories based on square footage. As a result, an overhead expense allocation is reflected in cost of revenue and each operating expense category.
Cost of revenue reflects the aggregate costs incurred in delivering test results and consists of: personnel costs, including salaries, employee benefit costs, bonuses, and equity-based compensation expenses; costs of laboratory supplies; depreciation of laboratory equipment; amortization of leasehold and building improvements and allocated overhead. Costs associated with performing tests are recorded as tests are processed.
Research and Development Expenses
Research and development expenses represent costs incurred to develop the Company’s technology and future tests. These costs consist of: personnel costs, including salaries, employee benefit costs, bonuses, and equity-based compensation expenses; laboratory supplies; consulting costs and allocated overhead. The Company expenses all research and development costs in the periods in which they are incurred.
Selling and Marketing Expenses
Selling and marketing expenses consist of: personnel costs, including salaries, employee benefit costs, bonuses, and equity-based compensation expenses; customer service expenses; direct marketing expenses; educational and promotional expenses; market research and analysis and allocated overhead. The Company expenses all selling and marketing costs as incurred.
General and Administrative Expenses
General and administrative expenses include executive, finance and accounting, legal, and human resources functions. These expenses consist of: personnel costs, including salaries, employee benefit costs, bonuses, and equity-based compensation expenses; audit and legal expenses; consulting costs and allocated overhead. The Company expenses all general and administrative expenses as incurred.
Restructuring Costs
Restructuring costs represent one-time employee termination benefits provided to employees associated with an acquired entity that were involuntarily terminated. A plan of termination was approved and authorized by management in the second quarter of 2022. The plan identified specific employees to be terminated and established terms of benefits those employees would receive upon termination. No additional costs are expected to be incurred under the plan of termination post 2022, and the full amount was paid off by August 2023.
Income Taxes
Income taxes are accounted for under the asset and liability method. The Company provides for federal, state and foreign income taxes currently payable, as well as for taxes deferred due to timing differences between reporting income and expenses for financial statement purposes versus tax purposes. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted income tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect of a change in income tax rates is recognized as income or expense in the period that includes the enactment date.
The Company recognizes the effect of income tax positions only if those positions are more likely than not to be sustained. Recognized income tax positions are measured at the largest amount with a greater than 50% likelihood of being realized. Changes in recognition or measurement are reflected in the period in which the change in judgment occurs. For income tax positions where it is not more likely than not that a tax benefit will be sustained, the Company does not recognize a tax benefit in its consolidated financial statements. The Company records interest and penalties related to uncertain tax positions, if applicable, as a component of income tax expense.
The Company releases income tax effects from other comprehensive income (loss) under the portfolio method. In 2024, the Company reclassified certain investments out of the available-for-sale debt security category. This reclassification resulted in the removal of unrealized gains or losses previously recorded in other comprehensive income (loss). The tax effects of these adjustments have been recognized, as a benefit of $2.1 million, in net loss to avoid stranded tax effects in other comprehensive income (loss).
Equity-Based Compensation
The Company grants various types of equity-based awards to its employees, consultants, and non-employee directors. Equity-based compensation costs are reflected in the accompanying Consolidated Statements of Operations based upon each award recipient’s role with the Company. The Company primarily grants to its employees restricted stock unit awards, or RSU awards, that generally vest over a specified period of time upon the satisfaction of service-based conditions or performance conditions. Compensation expense for employee RSU awards with a service-based vesting condition is recognized ratably over the vesting period of the award. Compensation expense for employee RSU awards with a performance condition is based on the probable outcome of that performance condition. The Company measures compensation expense for equity-based awards granted to employees based on the fair value of the award on the grant date of the award.
Foreign Currency Translation and Foreign Currency Transactions
The Company translates the assets and liabilities of its non-U.S. dollar functional currency subsidiaries into U.S. dollars using exchange rates in effect at the end of each period. Expenses for these subsidiaries are translated using rates that approximate those in effect during the period. Gains and losses from these translations are recognized in foreign currency translation gain (loss) included in the accompanying Consolidated Statements of Comprehensive Income (Loss). The Company and its subsidiaries that use the U.S. dollar as their functional currency remeasure monetary assets and liabilities at exchange rates in effect at the end of each period, and inventories, property and nonmonetary assets and liabilities at historical rates. Gains and losses from these measurements are included in other income, net, in the accompanying Consolidated Statements of Operations. Losses from foreign currency exchange were not significant in 2024, 2023, and 2022.
Comprehensive (Loss) Income
Comprehensive (loss) income is comprised of net (loss) income and other comprehensive (loss) income. Other comprehensive (loss) income consists of net unrealized gain or loss on available-for-sale debt securities, net of tax, and foreign currency translation adjustments from its subsidiaries not using the U.S. dollar as their functional currency. Reclassification from other comprehensive (loss) income to net loss, which includes reclassification of stranded tax effects, was$3.6 million in 2024. Reclassifications from other comprehensive income (loss) to net earnings were not significant in 2023 or 2022. The tax effects related to net unrealized gain or loss on available-for-sale debt securities were zero in 2024 and 2023, due to the valuation allowance in the current period that precludes the Company from recognizing the deferred tax benefit, and$7.2 million in 2022.
Basic and Diluted Net Income or Loss per Share
Basic net income or loss per common share is computed by dividing the net income or loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted net income or loss per common share is computed by dividing the net income or loss attributable to common stockholders by the weighted-average number of common shares and dilutive common share equivalents outstanding during the period.
Disaggregation of Revenue
The Company classifies its customers into three payor types: (i) Institutional, including hospitals, medical institutions, other laboratories, governmental bodies, municipalities, and large corporations, (ii) Insurance, including claim reimbursement from HRSA for uninsured individuals, or (iii) Patients who pay directly, as the Company believes this best depicts how the nature, amount, timing, and uncertainty of its revenue and cash flows are affected by economic factors. The following table summarizes revenue from contracts with customers by payor type for the years ended December 31, 2024, 2023, and 2022.
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| (in thousands) | |||
| Revenue by payor | |||
| Institutional | $154,733 | $134,191 | $239,961 |
| Insurance | 123,924 | 151,946 | 377,873 |
| Patient | 4,813 | 3,076 | 1,134 |
| Total revenue | $283,470 | $289,213 | $618,968 |
The insurance revenue category above includes zero for the years ended December 31, 2024 and 2023, and$83.1 million for the year ended December 31, 2022 for services related to claims covered by the HRSA COVID-19 Uninsured Program.
During the years ended December 31, 2024 and 2023, the Company experienced a change in estimate related to variable consideration.$1.8 million and$23.0 million variable consideration were recognized in the years ended December 31, 2024 and 2023, respectively, related to COVID-19 test services completed in the prior periods due to collection efforts, which was included as revenue from insurance in the table above. The Company estimates variable consideration using the expected value method. Any changes in variable consideration estimates that affect transactions are accounted for on a cumulative catch-up basis.
Contract Balances
Receivables from contracts with customers - Receivables from contracts with customers are included within trade accounts receivable on the Consolidated Balance Sheets. Receivables from Insurance and Institutional customers represented 44% and 56%, respectively, as of December 31, 2024 and 39% and 61%, respectively, as of December 31, 2023.
Contracts assets and liabilities - Contract assets from contracts with customers associated with contract execution and certain costs to fulfill a contract are included in other current assets in the accompanying Consolidated Balance Sheets. Contract liabilities are recorded when the Company receives payment prior to completing its obligation to transfer goods or services to a customer. Contract liabilities are included in the Consolidated Balance Sheets. Revenues of$2.5 million,$2.2 million and$14.4 million for the years ended December 31, 2024, 2023, and 2022, respectively, related to contract liabilities at the beginning of the respective periods were recognized.
Transaction Price Allocated to Future Performance Obligations
ASC 606 issued by the Financial Accounting Standards Board, or FASB, requires that the Company disclose the aggregate amount of transaction price that is allocated to performance obligations that have not yet been satisfied as of December 31, 2024. ASC 606 provides certain practical expedients that limit the requirement to disclose the aggregate amount of transaction price allocated to unsatisfied performance obligations.
The Company applied the practical expedient tonot disclose the amount of transaction price allocated to unsatisfied performance obligations when the performance obligation is part of a contract that has an original expected duration of one year or less. The Company does not have material future obligations associated with its testing services that extend beyond one year.
Prior Period Reclassifications
Certain amounts reported in the prior periods have been reclassified to conform with the current period presentation. In the Consolidated Statements of Cash Flow, the Company has separated prepaid income taxes from its previous inclusion in other current and long-term assets and separated customer deposits, and contract liabilities from its previous inclusion in accrued liabilities and other liabilities. In the Consolidated Statements of Operations, the Company has also separated interest income, and interest expenses from its previous inclusion in other income, net.
Recent Accounting Pronouncements
The Company evaluates all Accounting Standards Updates, or ASUs, issued by the Financial Accounting Standards Board, or FASB, for consideration of their applicability. ASUs not included in the Company’s disclosures were assessed and determined to be either not applicable or are not expected to have a material impact on the Company’s consolidated financial statements or disclosures.
Adopted
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segments. This update improves reportable segment disclosure requirements and requires enhanced disclosures related to significant segment expenses regularly provided to the CODM, the amount for other segment items with descriptions of the composition, segment profit or loss, and clarification on if the CODM uses more than one measurement of a segment’s profit or loss in assessing segment performance and deciding how to allocate resources. We adopted the guidance effective January 1, 2024 for annual reporting, and January 1, 2025 for interim reporting. Adoption of the guidance has affected the disclosures related to reportable segments, and have been applied retrospectively to all prior periods presented in the financial statements. For further information, refer to Note 7. Reportable Segment and Geographic Information for the presentation of the additional required disclosures.
Issued
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvement to Income Tax Disclosures. This update requires more detailed information on certain income tax disclosures including the income tax rate reconciliation and income taxes paid. Amendments in this update are effective for annual periods beginning December 15, 2024 for public entities, and early adoption is permitted. This update will result in enhanced income tax disclosures, and the Company does not expect any impact to income tax expense.
In November 2024, the FASB issued ASU 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. This update requires disclosure in the notes to financial statements, of specified information about certain costs and expenses. Amendments in this update are effective for annual periods beginning after December 15, 2026, and interim reporting periods beginning after December 15, 2027. Early adoption is permitted. The Company is currently evaluating the impacts of this amendment on the consolidated financial statements and related disclosure.
The Company does not expect that any other recently issued accounting guidance will have a significant effect on its consolidated financial statements.
Note 3. Equity and Debt Securities
The Company’s equity and debt securities consisted of the following:
| AmortizedCost Basis | UnrealizedGains | UnrealizedLosses | AggregateFair Value | |
|---|---|---|---|---|
| (in thousands) | ||||
| Equity securities | ||||
| Long-term | ||||
| Preferred stock of privately-held companies | $24,927 | $— | $— | $24,927 |
| Total equity securities | 24,927 | — | — | 24,927 |
| Available-for-sale debt securities | ||||
| Short-term | ||||
| U.S. government debt securities | 75,054 | 136 | (25) | 75,165 |
| U.S. agency debt securities | 65,490 | 72 | (23) | 65,539 |
| U.S. treasury bills | 44,366 | 19 | (2) | 44,383 |
| Corporate debt securities | 19,177 | 12 | (50) | 19,139 |
| Municipal bonds | 3,719 | 1 | (7) | 3,713 |
| Money market accounts | 19,720 | — | — | 19,720 |
| Less: Cash equivalents | (24,696) | (1) | — | (24,697) |
| Total debt securities due within 1 year | 202,830 | 239 | (107) | 202,962 |
| After 1 year through 5 years | ||||
| U.S. government debt securities | 379,060 | 565 | (2,283) | 377,342 |
| U.S. agency debt securities | 144,398 | 57 | (1,507) | 142,948 |
| Corporate debt securities | 47,801 | 114 | (150) | 47,765 |
| Municipal bonds | 1,820 | 2 | (4) | 1,818 |
| Yankee debt securities | 501 | — | (23) | 478 |
| Total debt securities due after 1 year through 5 years | 573,580 | 738 | (3,967) | 570,351 |
| Total available-for-sale debt securities | 776,410 | 977 | (4,074) | 773,313 |
| Total equity and debt securities | $801,337 | $977 | $(4,074) | $798,240 |
| AmortizedCost Basis | UnrealizedGains | UnrealizedLosses | AggregateFair Value | |
|---|---|---|---|---|
| (in thousands) | ||||
| Equity securities | ||||
| Long-term | ||||
| Preferred stock of privately-held company | $15,000 | $— | $— | $15,000 |
| Total equity securities | 15,000 | — | — | 15,000 |
| Available-for-sale debt securities | ||||
| Short-term | ||||
| U.S. government debt securities | 119,739 | 8 | (1,765) | 117,982 |
| U.S. agency debt securities | 72,310 | — | (1,414) | 70,896 |
| U.S. treasury bills | 69,214 | 36 | — | 69,250 |
| Corporate debt securities | 63,810 | — | (792) | 63,018 |
| Money market accounts | 38,291 | — | — | 38,291 |
| Municipal bonds | 5,557 | 1 | (23) | 5,535 |
| Less: Cash equivalents | (38,291) | — | — | (38,291) |
| Total debt securities due within 1 year | 330,630 | 45 | (3,994) | 326,681 |
| After 1 year through 5 years | ||||
| U.S. government debt securities | 247,104 | 1,262 | (578) | 247,788 |
| U.S. agency debt securities | 156,150 | 161 | (490) | 155,821 |
| Corporate debt securities | 12,885 | — | (765) | 12,120 |
| Municipal bonds | 6,337 | 2 | (48) | 6,291 |
| Yankee debt securities | 752 | — | (60) | 692 |
| Redeemable preferred stock investment | 20,000 | 438 | — | 20,438 |
| Total debt securities due after 1 year through 5 years | 443,228 | 1,863 | (1,941) | 443,150 |
| After 5 years through 10 years | ||||
| Municipal bonds | 868 | 1 | (10) | 859 |
| Total debt securities due after 5 years through 10 years | 868 | 1 | (10) | 859 |
| Total available-for-sale debt securities | 774,726 | 1,909 | (5,945) | 770,690 |
| Total equity and debt securities | $789,726 | $1,909 | $(5,945) | $785,690 |
Gross unrealized losses on the Company’s equity and debt securities were$4.1 million and$5.9 million as of December 31, 2024 and 2023, respectively. Proceeds from sale of available-for-sale securities were$104.3 million,$44.1 million, and$140.2 million in 2024, 2023, and 2022, respectively. Gross realized losses on the Company’s available-for-sale securities were$1.1 million,$0.6 million, and$1.4 million in 2024, 2023, and 2022, respectively, and the gross realized income was insignificant in 2024, 2023, and 2022. The cost of any marketable securities sold is based on the specific-identification method. The Company did not recognize any credit losses for its marketable available-for sale debt securities in 2024, 2023, and 2022.
See Note 2, Summary of Significant Accounting Policies, for the reclassification of available-for-sale securities to equity securities and a credit loss of $10.1 million recorded in 2024 related to Helio Health.
Note 4. Fair Value Measurements
The authoritative guidance on fair value measurements establishes a framework with respect to measuring assets and liabilities at fair value on a recurring basis and non-recurring basis. Under the framework, fair value is defined as the exit price, or the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants, as of the measurement date. The framework also establishes a three-tier hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs market participants would use in valuing the asset or liability and are developed based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the factors market participants would use in valuing the asset or liability and are developed based on the best information available in the circumstances. The hierarchy consists of the following three levels:
| Level 1: | Inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity can access at the measurement date. |
|---|---|
| Level 2: | Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. |
| Level 3: | Inputs are unobservable for the asset or liability. |
The following tables present information about the Company’s financial assets measured at fair value on a recurring basis, based on the three-tier fair value hierarchy:
| Total | Level 1 | Level 2 | Level 3 | |
|---|---|---|---|---|
| (in thousands) | ||||
| Equity securities, debt securities and cash equivalents | ||||
| U.S. government debt securities | $452,507 | $— | $452,507 | $— |
| U.S. agency debt securities | 208,487 | — | 208,487 | — |
| Corporate debt securities | 66,904 | — | 66,904 | — |
| U.S. treasury bills | 44,383 | 44,383 | — | — |
| Preferred stock of privately-held companies | 24,927 | — | — | 24,927 |
| Money market accounts | 19,720 | 19,720 | — | — |
| Municipal bonds | 5,531 | — | 5,531 | — |
| Yankee debt securities | 478 | — | 478 | — |
| Total equity securities, debt securities and cash equivalents | $822,937 | $64,103 | $733,907 | $24,927 |
| Total | Level 1 | Level 2 | Level 3 | |
|---|---|---|---|---|
| (in thousands) | ||||
| Equity securities, debt securities and cash equivalents | ||||
| U.S. government debt securities | $365,770 | $— | $365,770 | $— |
| U.S. agency debt securities | 226,717 | — | 226,717 | — |
| Corporate debt securities | 75,138 | — | 75,138 | — |
| U.S. treasury bills | 69,250 | 69,250 | — | — |
| Money market accounts | 38,291 | 38,291 | — | — |
| Redeemable preferred stock investment | 20,438 | — | — | 20,438 |
| Preferred stock of privately-held company | 15,000 | — | — | 15,000 |
| Municipal bonds | 12,685 | — | 12,685 | — |
| Yankee debt securities | 692 | — | 692 | — |
| Total equity securities, debt securities and cash equivalents | $823,981 | $107,541 | $681,002 | $35,438 |
The Company’s Level 1 assets include U.S. treasury bills and money market instruments and are valued based upon observable market prices. Level 2 assets consist of U.S. government and U.S. agency debt securities, municipal bonds, corporate debt securities and Yankee debt securities. Level 2 securities are valued based upon observable inputs that include reported trades, broker/dealer quotes, bids and offers. As of December 31, 2024 and 2023, the Company had preferred stock of two privately held companies, which were included in other long-term assets in the accompanying Consolidated Balance Sheets that were measured using unobservable
(Level 3) inputs. For the value of the investments in private equity securities, the Company elected to measure them at cost minus impairment, as the preferred stock of the privately-held companies did not have a readily determinable fair value, and no impairment loss was recorded as of December 31, 2024. As of December 31, 2023, the Company also had redeemable preferred stock, and the fair value of redeemable preferred stock was based on valuation performed by a third-party valuation company utilizing the guideline public company method under market approach and the discounted cash flow method under income approach. The redeemable preferred stock has been fully impaired as of December 31, 2024, see Note 2, Summary of Significant Accounting Policies, for more details.
There wereno transfers between fair value measurement levels in 2024, 2023, and 2022.
Note 5. Fixed Assets
Major classes of fixed assets consisted of the following:
| Useful Lives | December 31, 2024 | December 31, 2023 | |
|---|---|---|---|
| (in thousands) | |||
| Medical lab equipment | 1 to 13 Years | $57,541 | $56,025 |
| Building improvements | 6 months to 39 Years | 27,924 | 7,748 |
| Building | 25 to 39 Years | 21,689 | 9,781 |
| Computer hardware | 1 to 5 Years | 7,328 | 6,805 |
| Computer software | 1 to 10 Years | 7,214 | 7,982 |
| Aircraft | 7 Years | 6,400 | 6,400 |
| Furniture and fixtures | 1 to 11 Years | 4,109 | 3,860 |
| Leasehold improvements | Shorter of lease term or estimated useful life | 3,323 | 11,222 |
| Land improvements | 15 Years | 904 | 904 |
| Automobile | 3 to 8 Years | 581 | 445 |
| General equipment | 5 Years | 108 | 115 |
| Land | 17,347 | 8,800 | |
| Assets not yet placed in service | 2,792 | 15,010 | |
| Total | 157,260 | 135,097 | |
| Less: Accumulated depreciation | (51,711) | (51,633) | |
| Fixed assets, net | $105,549 | $83,464 | |
Depreciation expense on fixed assets totaled$16.4 million,$17.5 million and$25.5 million for the years ended December 31, 2024, 2023, and 2022, respectively.
Note 6. Other Significant Balance Sheet Accounts
Other current assets consisted of the following:
| December 31, 2024 | December 31, 2023 | |
|---|---|---|
| (in thousands) | ||
| Reagents and supplies | $8,384 | $5,827 |
| Prepaid expenses | 6,629 | 7,744 |
| Marketable securities interest receivable | 6,241 | 4,994 |
| Prepaid income taxes | 3,422 | 12,675 |
| Other receivable | 1,768 | 1,319 |
| Total | $26,444 | $32,559 |
Accrued liabilities consisted of the following:
| December 31, 2024 | December 31, 2023 | |
|---|---|---|
| (in thousands) | ||
| Payroll liabilities | $8,210 | $5,741 |
| Accrued bonus and commission | 5,803 | 6,255 |
| Vacation accrual | 4,088 | 3,543 |
| Operating lease liabilities - short term | 1,443 | 3,957 |
| Accrued legal liabilities | 1,101 | 7,026 |
| Other accrued liabilities | 3,634 | 4,215 |
| Total | $24,279 | $30,737 |
Accrued legal liabilities as of December 31, 2024 included $1.0 million in connection with the SEC investigation as further described in Note 8, Debt, Commitments, and Contingencies. Accrued legal liabilities as of December 31, 2023 included a previously estimated $6.9 million in connection with the Company’s voluntary disclosure process, which was settled at approximately $3.0 million and paid in 2024. Other accrued liabilities included short-term finance lease liabilities, health insurance liabilities, and third-party billing services.
Other long-term liabilities consisted of the following:
| December 31, 2024 | December 31, 2023 | |
|---|---|---|
| (in thousands) | ||
| Operating lease liabilities, long term | $4,120 | $7,147 |
| Notes payable, long term | 2,493 | 2,964 |
| Other long-term liabilities | 360 | 4,973 |
| Total | $6,973 | $15,084 |
Note 7. Reportable Segment and Geographic Information
The Company hastwo distinct reportable segments. The laboratory services operating segment offers technical laboratory and testing services and professional interpretation of laboratory results by licensed physicians who specialize in pathology and oncology. The therapeutic development operating segment is a pharmaceutical research and development entity.
The Company’s Chief Executive Officer serves as its Chief Operating Decision Maker, or CODM. The CODM oversees the Company’s operations and evaluates financial data for itstwo operating segments separately to make resource allocation decisions. The financial information regularly provided to the CODM includes various performance metrics by reporting segment, such as gross profit, operating income or loss, income or loss before income taxes, net income or loss from consolidated operations, and net income or loss attributable to Fulgent, all presented in accordance with U.S. GAAP. Additionally, the CODM receives these metrics on a non-GAAP basis, which excludes the impact of equity-based compensation expenses, goodwill impairment losses, amortization of intangible assets, and restructuring costs, if applicable. Although multiple financial metrics are provided, the CODM primarily relies on adjusted operating income or loss to evaluate segment performance and allocate resources. The balance sheet is presented on a consolidated basis, as the CODM does not use asset or liability information, including fixed assets, to assess segment performance. As a result, segment asset and liability details are not disclosed.
There is no inter-segment allocation of interest expense and income taxes. There is no inter-segment revenue and operating income or loss. The Company did not allocate income tax by segment. Information regarding the Company’s operations and assets for its reporting segments as well as geographic information are as follows, all dollars are in thousands:
| Laboratory Services | Therapeutic Development | Total | |
|---|---|---|---|
| Revenue | $283,470 | $— | $283,470 |
| Less: | |||
| Adjusted cost of revenue | 168,456 | — | 168,456 |
| Adjusted research and development | 18,213 | 15,632 | 33,845 |
| Adjusted selling and marketing | 32,339 | — | 32,339 |
| Adjusted general and administrative | 69,374 | 928 | 70,302 |
| Total adjusted operating loss | $(4,912) | $(16,560) | $(21,472) |
| Laboratory Services | Therapeutic Development | Total | |
|---|---|---|---|
| Revenue | $289,213 | $— | $289,213 |
| Less: | |||
| Adjusted cost of revenue | 175,008 | — | 175,008 |
| Adjusted research and development | 19,577 | 6,990 | 26,567 |
| Adjusted selling and marketing | 36,503 | — | 36,503 |
| Adjusted general and administrative | 74,982 | 681 | 75,663 |
| Total adjusted operating loss | $(16,857) | $(7,671) | $(24,528) |
| Laboratory Services | Therapeutic Development | Total | |
|---|---|---|---|
| Revenue | $618,968 | $— | $618,968 |
| Less: | |||
| Adjusted cost of revenue | 243,363 | — | 243,363 |
| Adjusted research and development | 17,715 | 746 | 18,461 |
| Adjusted selling and marketing | 34,545 | — | 34,545 |
| Adjusted general and administrative | 101,890 | 70 | 101,960 |
| Total adjusted operating income (loss) | $221,455 | $(816) | $220,639 |
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| Reconciliation of “adjusted operating (loss) income” to “(loss) income before income taxes” | |||
| Adjusted operating (loss) income | $(21,472) | $(24,528) | $220,639 |
| Less (add): | |||
| Equity-based compensation | 44,481 | 42,922 | 32,640 |
| Amortization of intangible assets | 7,965 | 7,845 | 6,497 |
| Goodwill impairment loss | — | 120,234 | — |
| Restructuring costs | — | — | 2,975 |
| Interest income | (31,304) | (21,612) | (5,624) |
| Interest expense | (170) | 488 | 1,013 |
| Impairment of available-for-sale debt securities | 10,073 | — | — |
| Other income, net | (561) | (320) | (887) |
| Total (loss) income before income taxes | $(51,956) | $(174,085) | $184,025 |
Significant items by segment excluded from the adjusted operating (loss) income:
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| Equity-based compensation | |||
| Laboratory services | $36,951 | $35,649 | $32,640 |
| Therapeutic development | 7,530 | 7,273 | — |
| Total | $44,481 | $42,922 | $32,640 |
Revenue by segment:
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| Revenue | |||
| Laboratory services: | |||
| Precision diagnostics | $167,745 | $131,990 | $93,685 |
| Anatomic pathology | 97,080 | 104,655 | 74,799 |
| BioPharma services | 16,338 | 25,416 | 12,977 |
| COVID-19 | 2,307 | 27,152 | 437,507 |
| Total laboratory services | 283,470 | 289,213 | 618,968 |
| Therapeutic development | — | — | — |
| Total | $283,470 | $289,213 | $618,968 |
Depreciation and amortization by segment:
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| Depreciation and amortization | |||
| Laboratory services | $24,240 | $25,453 | $32,557 |
| Therapeutic development | 688 | 690 | 105 |
| Total | $24,928 | $26,143 | $32,662 |
Interest income and expense by segment:
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| Interest income and expense | |||
| Laboratory services | |||
| Interest income | $31,304 | $21,612 | $5,624 |
| Interest expense | 170 | (488) | (1,013) |
| Therapeutic development | |||
| Interest income | — | — | — |
| Interest expense | — | — | — |
| Total | $31,474 | $21,124 | $4,611 |
Total assets by segment:
| December 31, 2024 | December 31, 2023 | December 31, 2022 | |
|---|---|---|---|
| Assets | |||
| Laboratory services | $1,131,117 | $1,146,192 | $1,292,821 |
| Therapeutic development | 88,847 | 89,136 | 93,232 |
| Total | $1,219,964 | $1,235,328 | $1,386,053 |
Geographic distribution of revenue:
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| Revenue | |||
| United States | $259,132 | $268,977 | $603,148 |
| Foreign | |||
| China | 12,638 | 11,446 | 8,939 |
| Other countries | 11,700 | 8,790 | 6,881 |
| Total foreign | 24,338 | 20,236 | 15,820 |
| Total | $283,470 | $289,213 | $618,968 |
Geographic distribution of property, plant and equipment, net:
| December 31, 2024 | December 31, 2023 | December 31, 2022 | |
|---|---|---|---|
| Fixed assets | |||
| United States | $98,992 | $77,938 | $72,617 |
| Foreign | |||
| China | 4,616 | 5,526 | 8,736 |
| Other countries | 1,941 | — | — |
| Total foreign | 6,557 | 5,526 | 8,736 |
| Total | $105,549 | $83,464 | $81,353 |
Note 8. Debt, Commitments and Contingencies
Debt
Notes payable as of December 31, 2024, consisted of$2.9 million of notes payable related to an installment sale contract the Company entered in February 2022 for a building. The notes payable related to the installment sale are due in February 2030, and the interest rate is 1.08%. The current portion and noncurrent portion are$0.4 million and$2.5 million, respectively, and the noncurrent portion is included in the other long-term liabilities in the accompanying Consolidated Balance Sheets. The Company also had notes payable to Xilong Scientific Co., which were paid off in 2024, and had an interest rate of 4.97%. The interest expenses in 2024 and 2023 were not significant, and was$0.3 million in 2022.
Operating and Finance Leases
See Note 9, Leases, for further information.
Purchase Obligations
The Company entered certain purchase commitments with its vendors, which primarily consist of services, reagent and supplies, computer software, and medical lab equipment. As of December 31, 2024, the Company had purchase obligations of$40.6 million, of which$31.6 million is payable within 12 months, and the remainder,$9.0 million, is payable within the next five years.
Contingencies
From time to time, the Company may be subject to legal proceedings and claims arising in the ordinary course of business.
As previously disclosed in the Company’s periodic reports filed pursuant to the Securities Exchange Act of 1934, as amended, or the Exchange Act, the Company has received a Civil Investigative Demand, or CID, issued by the U.S. Department of Justice, or the DOJ, pursuant to the False Claims Act related to its investigation of allegations of medically unnecessary laboratory testing, improper billing for laboratory testing, and remuneration received or provided in violation of the Anti-Kickback Statute and the Stark Law. Among other things, this CID requests information and records relating to certain of the Company’s customers named in this CID.
Similar to other laboratories in the industry, the Company is currently being audited by the U.S. Health Resources and Services Administration, or HRSA, with respect to its reimbursement for COVID-19 tests furnished to patients believed to be uninsured. The Company recorded approximately $548.9 million of reimbursements from HRSA under the Uninsured Program during the years ended December 31, 2022, 2021, and 2020. There is uncertainty with respect to the methodology HRSA will use in its audit and whether and how HRSA will extrapolate audit results. The Company is working with HRSA’s auditors to resolve any issues related to its audit, including any reimbursed amounts that may need to be returned to HRSA. The Company has also received a CID issued by the DOJ pursuant to the False Claims Act related to the DOJ’s investigation as to whether the Company submitted or caused to be submitted false claims to the Uninsured Program.
The Company is fully cooperating with the DOJ in connection with the CIDs that it has received, and in connection with the HRSA audit. The Company cannot currently predict when these CIDs and HRSA audit matters will be resolved, the reasonable or likely outcome of these matters, or their potential impact, which may materially and adversely affect the Company’s business, prospects, and financial condition. These matters are not formal claims, and discussions and investigations remain ongoing. As such, the Company cannot reasonably estimate the loss or range of loss, if any, that may result from any material government investigations, audits, and reviews in which it is currently involved, given the inherent difficulty in predicting regulatory action, fines and penalties, if any, and the various remedies and levels of judicial review available to the Company in the event of an adverse finding. As a result, the Company has not recorded any liability related to these CIDs or audit matters.
In addition, and as previously disclosed, the SEC is conducting a non-public formal investigation, which relates to (i) the matters raised in the requests for the CID regarding allegations of medically unnecessary laboratory testing, improper billing for laboratory testing, and remuneration received or provided in violation of the Anti-Kickback Statute and the Stark Law and (ii) the Company’s Exchange Act reports filed for 2018 through 2020. On May 6, 2024, the SEC staff advised the Company that the SEC staff made a preliminary determination to recommend that the SEC file an enforcement action against the Company based on a corporate negligence theory, which, if authorized, would allege violations of Sections 17(a)(2) and 17(a)(3) of the Securities Act of 1933, as amended, Sections 13(a), 13(b)(2)(A) and 13(b)(2)(B) of the Exchange Act, and Rules 13a-1, 13a-13, and 12b-20 thereunder. The Company has fully cooperated with the SEC and its requests, and the SEC are continuing to communicate regarding this matter. While the Company does not believe that any enforcement recommendation is warranted and denies all liability, the Company has recorded a $1.0 million potential liability with respect to this matter. While the Company believes this amount is a reasonable and probable estimate, the actual amount of liability, if any, may be materially higher than this estimate, as discussions are ongoing, and there is no formal settlement or final resolution of this matter at this time.
In relation to a recent advisory opinion issued by the Office of Inspector General of the Department of Health and Human Services, or the OIG, the Company’s subsidiary, Symphony Buyer, Inc., or Inform Diagnostics, initiated a voluntary disclosure process with the appropriate government contact. The Company had previously estimated and recorded $6.9 million as a liability in its financial statements in connection with this voluntary disclosure. In December 2024, the Company entered into a settlement agreement with the DOJ pursuant to which it agreed to pay and paid $3.0 million in resolution of the matters directly related to this voluntary disclosure.
Note 9. Leases
Lessee
The Company is party as a lessee to various non-cancelable operating leases with varying terms through March 2034 primarily for laboratory and office space and equipment. The Company has options to renew some of these leases after their expirations. On a lease-by-lease basis, the Company considers such options, which may be elected at the Company’s sole discretion, in determining the lease term. The Company also has various finance leases for lab equipment with varying terms through December 2026, of which, some were acquired in business combinations. The Company does not have any leases with variable lease payments. The Company’s operating lease agreements do not contain any residual value guarantees, material restrictive covenants, bargain purchase options or asset retirement obligations.
The Company’s headquarters are located in El Monte, California, which is comprised of various corporate offices and a laboratory certified under the Clinical Laboratory Improvement Amendments of 1988, or CLIA, accredited by the College of American Pathologists, or CAP, and licensed by the State of California Department of Public Health. Other CLIA-certified laboratories are located in Coppell, Texas; Needham, Massachusetts; Phoenix, Arizona; Alpharetta, Georgia. The Company is also in the process of obtaining NATA accreditation in Dulwich, Australia.
The operating and finance lease right-of-use asset, short-term lease liabilities, and long-term lease liabilities as of December 31, 2024 and 2023 were as follows:
| December 31, 2024 | December 31, 2023 | |
|---|---|---|
| (in thousands) | ||
| Operating lease ROU asset, net | $5,395 | $10,838 |
| Operating lease liabilities, short term | $1,443 | $3,957 |
| Operating lease liabilities, long term | $4,120 | $7,147 |
| Finance lease ROU asset, net | $771 | $1,316 |
| Finance lease liabilities, short term | $398 | $544 |
| Finance lease liabilities, long term | $360 | $760 |
The following was operating and finance lease expense:
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| (in thousands) | |||
| Operating lease cost | $4,176 | $6,875 | $5,429 |
| Finance lease cost: | |||
| Amortization of ROU assets | 539 | 758 | 683 |
| Interest on lease liabilities | 39 | 80 | 95 |
| Short-term lease cost | 1,346 | 1,758 | 1,528 |
| Total lease cost | $6,100 | $9,471 | $7,735 |
Supplemental information related to leases was the following:
| Weighted-average remaining lease term, operating leases | 5.95 years |
|---|---|
| Weighted-average discount rate, operating leases | 5.27% |
| Weighted-average remaining lease term, finance lease | 1.90 years |
| Weighted-average discount rate, finance lease | 3.39% |
The following is a maturity analysis of operating and finance lease liabilities using undiscounted cash flows on an annual basis with renewal periods included:
| Operating Leases · Finance Lease | ||
|---|---|---|
| (in thousands) | ||
| Year ending December 31, | ||
| 2025 | $1,707 | $417 |
| 2026 | 1,117 | 366 |
| 2027 | 1,011 | — |
| 2028 | 484 | — |
| 2029 | 500 | — |
| Thereafter | 1,832 | — |
| Total lease payments | 6,651 | 783 |
| Less imputed interest | (1,088) | (25) |
| Total | $5,563 | $758 |
Lessor
The Company previously leased out space in buildings it owns to third-party tenants under noncancelable operating leases. As of December 31, 2024, there were no noncancelable operating leases remaining. Lease income primarily represents fixed lease payments from tenants recognized on a straight-line basis over the application lease term. Variable lease income represents tenant payments for real estate taxes, insurance and maintenance.
The lease income was included in other income, net, in the accompanying Consolidated Statements of Operations. An insignificant amount was recognized in the year ended December 31, 2024. For years ended December 31, 2023 and 2022, $0.2 million and $0.3 million were recognized, respectively. There areno future fixed lease payments from tenants expected, as there were no remaining noncancelable operating leases as of December 31, 2024.
Note 10. Equity-Based Compensation
The Company has included equity-based compensation expense as part of cost of revenue and operating expenses in the accompanying Consolidated Statements of Operations as follows:
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| (in thousands) | |||
| Cost of revenue | $7,799 | $9,749 | $8,704 |
| Research and development | 14,971 | 14,873 | 10,449 |
| Selling and marketing | 3,907 | 4,964 | 4,373 |
| General and administrative | 17,804 | 13,336 | 9,114 |
| Total | $44,481 | $42,922 | $32,640 |
The actual tax (expense) benefit realized from tax deductions related to awards vested or exercised were($3.4) million,($2.7) million and$2.1 million for the years ended December 31, 2024, 2023, and 2022, respectively.
Award Activity
Option Awards
The following table summarizes activity for options to acquire shares of the Company’s common stock in the years ended December 31, 2024, 2023, and 2022:
| Numberof SharesSubject toOptions (in thousands) | Weighted-AverageExercise Price | Weighted-AverageGrant Date Fair Value | Weighted-AverageRemainingContractual Life(in years) | AggregateIntrinsicValue(in thousands) (1) | |
|---|---|---|---|---|---|
| Balance at December 31, 2021 | 216 | $3.42 | 4.6 | $20,965 | |
| Granted | 10 | $59.54 | $44.56 | ||
| Exercised | (5) | $7.16 | $7.41 | ||
| Canceled | (9) | $43.30 | $33.53 | ||
| Balance at December 31, 2022 | 212 | $4.21 | 3.7 | $5,420 | |
| Granted | 20 | $33.14 | $24.85 | ||
| Exercised | (9) | $0.38 | $10.76 | ||
| Canceled | — | $— | $— | ||
| Balance at December 31, 2023 | 223 | $6.96 | 3.3 | $4,906 | |
| Granted | 5 | $22.50 | $16.42 | ||
| Exercised | (133) | $0.38 | $2.58 | ||
| Canceled | — | $— | $— | ||
| Balance at December 31, 2024 | 95 | $17.07 | 4.7 | $134 | |
| Exercisable as of December 31, 2024 | 74 | $11.51 | 3.7 | ||
(1)
Aggregate intrinsic value is calculated as the difference between (i) the exercise price of options and (ii) the market value of the Company’s common stock as of the applicable date.
The total fair value of options that vested during the years ended December 31, 2024, 2023, and 2022 was$0.3 million,$0.2 million and$0.1 million, respectively. As of December 31, 2024, the remaining unrecognized compensation expense related to all outstanding option awards was$0.5 million and is expected to be recognized over a weighted-average period of 2.2 years.
RSU Awards
RSUs are awards that entitle the holder to receive shares of the Company’s common stock upon satisfaction of vesting conditions. Each RSU represents the contingent right to receive one share of the Company’s common stock upon vesting and settlement.
The following table summarizes activity for RSUs relating to shares of the Company’s common stock in the years ended December 31, 2024, 2023, and 2022:
| Number ofShares(in thousands) | Weighted-AverageGrant DateFair Value | |
|---|---|---|
| Balance at December 31, 2021 | 1,619 | $40.74 |
| Granted | 1,895 | $49.98 |
| Vested and settled | (699) | $34.01 |
| Forfeited | (184) | $61.11 |
| Balance at December 31, 2022 | 2,631 | $47.76 |
| Granted | 853 | $34.38 |
| Vested and settled | (1,066) | $43.84 |
| Forfeited | (208) | $54.72 |
| Balance at December 31, 2023 | 2,210 | $43.84 |
| Granted | 1,142 | $23.47 |
| Vested and settled | (1,004) | $43.66 |
| Forfeited | (142) | $37.39 |
| Balance at December 31, 2024 | 2,206 | $33.85 |
The RSU awards granted in the years ended December 31, 2024, 2023, and 2022 will result in aggregate equity-based compensation expense of$26.9 million,$29.3 million and$94.8 million, respectively, to be recognized over the vesting periods from the grant date of each award granted in the period. As of December 31, 2024, the remaining unrecognized compensation expense related to all outstanding RSU awards was$64.4 million and is expected to be recognized over a weighted-average period of 2.2 years.
Fair Value Assumptions for Option Awards
The Company uses the Black-Scholes option-pricing model to measure the fair value of option awards. The Black-Scholes option-pricing model requires the input of various assumptions, each of which is subjective and requires significant judgment. These assumptions include the following:
Expected Term. The expected term represents the period that the Company’s equity-based awards are expected to be outstanding. The Company determines the expected term assumption based on the vesting terms, exercise terms and contractual terms of the options.
Risk-Free Interest Rate. The Company determines the risk-free interest rate by using the equivalent to the expected term based on the U.S. Treasury yield curve in effect as of the date of grant.
Dividend Yield. The assumed dividend yield is based on the Company’s expectation that it will not pay dividends in the foreseeable future, which is consistent with its history of not paying dividends.
Expected Volatility. The Company calculates expected volatility based on historical volatility data of its stock that is publicly traded.
Forfeiture Rate. The Company accounts for forfeitures as they occur.
Awards to Employees
The table below sets forth the weighted-average assumptions used in the Black-Scholes option-pricing model to estimate the fair value of options to acquire shares of the Company’s common stock granted to employees during the years ended December 31, 2024, 2023, and 2022.
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| Expected term (in years) | 6.1 | 6.1 | 6.1 |
| Risk-free interest rates | 4.3% | 3.8% | 2.6% |
| Dividend yield | — | — | — |
| Expected volatility | 82.2% | 87.3% | 88.7% |
Determination of Fair Value on Grant Dates
The fair value of the shares of the Company’s common stock underlying option and RSU awards is determined by the Company’s board of directors or the compensation committee thereof based on the closing sales price of the Company’s common stock on the date of grant as reported by the Nasdaq Global Market.
Note 11. Income Taxes
(Benefit from) provision for income taxes consists of United States federal and state income taxes. A deferred tax liability is recognized for all taxable temporary differences, and a deferred tax asset is recognized for all deductible temporary differences, operating losses and tax credit carryforwards. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized.
The following table summarizes income (loss) before income taxes:
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| (in thousands) | |||
| U.S. (loss) income before income taxes | $(46,813) | $(147,464) | $189,406 |
| Foreign loss before income taxes | (5,143) | (26,621) | (5,381) |
| (Loss) income before income taxes | $(51,956) | $(174,085) | $184,025 |
(Benefit from) provision for income taxes consisted of the following:
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| (in thousands) | |||
| Current | |||
| Federal | $(2,441) | $(5,590) | $31,140 |
| State | (2,107) | (4,722) | 19,242 |
| Foreign | 148 | — | — |
| Total Current | (4,400) | (10,312) | 50,382 |
| Deferred | |||
| Federal | (10,313) | (12,771) | (3,763) |
| State | (734) | 4,100 | (4,517) |
| Foreign | 602 | (188) | 224 |
| Change in valuation allowance | 6,709 | 20,325 | (224) |
| Total Deferred | (3,736) | 11,466 | (8,280) |
| Total (benefit from) provision for income taxes | $(8,136) | $1,154 | $42,102 |
Reconciliation of the difference between the federal statutory income tax rate and the effective income tax rate is as follows:
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| Tax provision at federal statutory rate | 21.00% | 21.00% | 21.00% |
| State taxes | -1.70% | 0.22% | 9.03% |
| Equity-based compensation | -6.79% | -1.65% | -1.12% |
| Nondeductible compensation - 162(m) | -2.10% | -0.55% | 0.00% |
| Goodwill impairment | 0.00% | -10.62% | 0.00% |
| Amended state tax refunds | 8.29% | 0.00% | 0.00% |
| Federal return to provision | -2.07% | -0.21% | -3.92% |
| State return to provision | -0.78% | 3.41% | -2.02% |
| Other permanent differences | 1.83% | -1.15% | 1.33% |
| Uncertain tax positions | -1.14% | 0.18% | 0.92% |
| Research & development credit | 6.95% | 3.19% | -2.98% |
| IRA tax credit | 4.82% | 0.00% | 0.00% |
| Foreign tax rate differential | -1.68% | -2.42% | 0.00% |
| Stranded tax effect | 4.25% | 0.00% | 0.00% |
| Foreign NOL carryforward | -1.19% | 0.11% | -0.12% |
| Other | -0.29% | 0.00% | 0.46% |
| Change in valuation allowance | -13.29% | -12.20% | 0.12% |
| Effective tax rate | 16.11% | -0.69% | 22.70% |
The following table summarizes the elements of the deferred tax assets (liabilities). Net deferred tax assets are included in other long-term assets in the Consolidated Balance Sheets.
| As of December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| (in thousands) | ||
| Deferred tax assets | ||
| Accrued vacation and other accrued expenses | $1,775 | $807 |
| Provision for credit losses | 2,990 | 818 |
| Net operating losses | 11,875 | 17,496 |
| Equity-based compensation | 2,022 | 906 |
| State income taxes | 284 | 211 |
| Excess tax basis in FF Gene Biotech net assets | 1,527 | 2,256 |
| Lease liability | 789 | 2,345 |
| Unrealized gain/loss on available-for-sale debt securities | 757 | 406 |
| Research and development credits | 2,762 | 1,258 |
| Section 174 research & experimental expenditures | 25,626 | 18,606 |
| Equity loss in investment | 2,965 | 503 |
| Other | 74 | 107 |
| Gross deferred tax assets | 53,446 | 45,719 |
| Less: Valuation allowance | (22,702) | (15,900) |
| Net deferred tax assets | 30,744 | 29,819 |
| Deferred tax liabilities | ||
| Intangible assets | 29,540 | 30,558 |
| Depreciation | 6,198 | 3,901 |
| Right of use asset | 767 | 2,299 |
| Other | 609 | 1,023 |
| Total deferred tax liabilities | 37,114 | 37,781 |
| Net deferred tax liabilities | $(6,370) | $(7,962) |
As of December 31, 2024, the Company has$31.5 million estimated federal net operating loss, or NOL, carryforwards and estimated state NOL carryforwards of$82.6 million. The Company’s state NOLs are scheduled to begin expiring in 2025. The
Company also has foreign NOL carryforwards of$11.0 million which are scheduled to expire from 2025 through 2029. Utilization of our net operating loss carryforwards may be subject to annual limitations due to ownership changes as imposed by the Internal Revenue Code and similar state provisions.
ASC 740-10-30-5 requires that deferred income tax assets be reduced by a valuation allowance if it is more likely than not that some or all of the deferred income tax assets will not be realized. The Company has evaluated the realizability of its deferred tax assets and has concluded that it is more likely than not that the Company may not realize the benefit of certain deferred tax assets and, accordingly, has established a full valuation allowance of$22.7 million on its deferred tax assets as of December 31, 2024. The Company maintained a full valuation allowance of$15.9 million on its deferred tax assets as of December 31, 2023. The increase in the valuation allowance of$6.8 million for the year ended December 31, 2024 was primarily due to the increase in capitalized Section 174 expenditures.
The Organization for Economic Cooperation and Development (OECD) has enacted model rules for a new global minimum tax framework (“BEPS Pillar II”). Various jurisdictions have enacted, or are in the process of enacting, legislation on these rules. We are closely monitoring developments and are currently evaluating the potential impact in each jurisdiction in which we operate.
Uncertain Tax Positions
The Company is subject to income taxation by the United States government and certain states in which the Company’s activities give rise to an income tax filing requirement. The Company does not have any significant income tax filing requirements in any foreign jurisdiction. The Company’s tax returns are subject to statutes of limitations that vary by jurisdiction. As of December 31, 2024, the Company remains subject to income tax examinations in the United States, and various states for tax years 2020 through 2024. However, due to the Company’s NOL carryforwards in various jurisdictions, tax authorities have the ability to adjust carryforwards related to closed years until the statute expires on the year(s) in which the NOL carryforwards are utilized.
The Company is under examination by certain tax authorities for the 2020 and 2021 tax years. While the timing of the conclusion of the examination is uncertain, the Company believes that adequate amounts have been reserved for adjustments that may result.
A reconciliation of the Company’s gross unrecognized tax benefits is as follows:
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| (in thousands) | |||
| Balance at beginning of year | $5,833 | $9,742 | $710 |
| Increases to prior year positions | (2,692) | (3,845) | 2,843 |
| Increases for current year positions | 1,035 | (64) | 6,189 |
| Balance at end of year | $4,176 | $5,833 | $9,742 |
As of December 31, 2024, the Company has$4.2 million of gross unrecognized tax benefits, of which,$2.5 million of unrecognized tax benefits would affect the effective tax rate if recognized. The Company has accrued$0.4 million and$0.1 million for interest at December 31, 2024 and 2023, respectively. Although it is possible that the amount of unrecognized benefits with respect to our uncertain tax positions will increase or decrease in the next 12 months, the Company does not expect material changes.
While the Company believes it has adequately provided for all tax positions, amounts asserted by taxing authorities could differ from the Company’s accrued positions. Accordingly, additional provisions on federal, state and foreign tax-related matters could be recorded in future periods as revised estimates are settled or otherwise resolved.
The Company received $40.0 million, $12.5 million, and $0.3 million in income tax refunds in 2024, 2023, and 2022, respectively. The income tax refunds received, which were due to overpayment in prior years, were not netted in the income tax paid amounts included in the supplemental disclosure in the accompanying Consolidated Statements of Cash Flows.
In 2024, the Company purchased $27.1 million worth of Investment Tax Credits, or ITCs, under the transferability provisions of the Inflation Reduction Act of 2022 for $24.6 million in cash. The $2.5 million difference between the purchase price and the face value of the credits has been recorded as an increase to the Company’s income tax benefit for the period. The $24.6 million cash payment was included in the income tax paid amounts included in the supplemental disclosure in the accompanying Consolidated Statements of Cash Flows. The Company has utilized $0.4 millionof the acquired credits on its 2023 tax return and carried back the remainderof $26.7 million to its 2020 tax year and filed a request for a refund. The Company has received the full amount of $26.7 million of ITCs that were carried back to the 2020 tax year in cash in 2024.
Note 12. Income (Loss) per Share
The following is a reconciliation of the basic and diluted income (loss) per share computations:
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| (in thousands) | |||
| Net (loss) income attributable to Fulgent | $(42,708) | $(167,825) | $143,403 |
| Weighted-average common shares - outstanding, basic | 30,235 | 29,784 | 30,097 |
| Weighted-average effect of dilutive securities: | |||
| Stock options | — | — | 199 |
| Restricted stock units | — | — | 613 |
| Contingently issuable shares | — | — | 55 |
| Weighted-average common shares - outstanding, diluted | 30,235 | 29,784 | 30,964 |
| (Loss) income per share: | |||
| Basic | $(1.41) | $(5.63) | $4.76 |
| Diluted | $(1.41) | $(5.63) | $4.63 |
Thefollowing securities have been excluded from the calculation of diluted income (loss) per share because their effect would have been anti-dilutive:
| Year Ended December 31, | |||
|---|---|---|---|
| 2024 | 2023 | 2022 | |
| (in thousands) | |||
| Stock options | 95 | 224 | 10 |
| Restricted stock units | 2,206 | 2,210 | 728 |
| Contingently issuable shares | — | 186 | — |
The anti-dilutive shares described above were calculated using the treasury stock method. In the years ended December 31, 2024 and 2023, the Company had outstanding stock options and restricted stock units that were excluded from the weighted-average share calculation for continuing operations due to the Company’s net loss positions. In the year ended December 31, 2023, the Company also had contingently issuable shares for shares held back in connection with the business combination of Fulgent Pharma, or Pharma Hold Back Shares. In May 2024, the Company released the remaining Pharma Hold Back Shares such that no shares remain contingently issuable in connection with the business combination of Fulgent Pharma.
Note 13. Retirement Plans
The Company offers a 401(k) retirement savings plan, or the 401 (k) Plan, for its employees, including its executive officers, who satisfy certain eligibility requirements. The Internal Revenue Code of 1986, as amended, allows eligible employees to defer a portion of their compensation, within prescribed limits, on a pre-tax basis through contributions to the 401(k) Plan. The Company matches contributions to the 401(k) Plan based on the amount of salary deferral contributions the participant makes to the 401(k) Plan. The Company will match up to 4% of an employee’s compensation that the employee contributes to their 401(k) Plan account. Total Company matching contributions to the 401(k) Plan were$3.8 million,$3.2 million and$2.5 million in the years ended December 31, 2024, 2023, and 2022, respectively.
Note 14. Related Party
Linda Marsh, who is a member of the Company’s board of directors, is currently the Senior Executive Vice President of AHMC Healthcare Inc., or AHMC. The Company performs genetic testing and other testing services, on an arms-length basis, for AHMC, and the Company recognizedan insignificant amount,$0.1 million and$1.5 million in revenue in the years ended December 31, 2024, 2023, and 2022, respectively. As of December 31, 2024 and 2023, insignificant amounts were owed to the Company by AHMC, which is included in trade accounts receivable, net, in the accompanying Consolidated Balance Sheets, in connection with this relationship.
Ming Hsieh, is the owner of PTJ Associates Inc., or PTJ. PTJ provides flight services to the Company on an arms-length basis. In the years ended December 31, 2024, 2023, and 2022 the Company incurred zero, zero and$0.2 million, respectively, in expenses for flights between California and Texas to transport employees and supplies. As of December 31, 2024 and 2023, no amount was owed to PTJ by the Company.
Ming Hsieh is also on the board of directors and an approximately 20% owner of ANP Technologies, Inc., or ANP, from which the Company entered into certain drug-related licensing and development service agreements. The President and Chief Scientific Officerof Fulgent Pharma, Ray Yin, is the Founder, President, and Chief Technology Officer of ANP. The Company incurred$2.1 million,$2.4 million and$1.2 million, in expenses in the years ended December 31, 2024, 2023, and 2022, respectively, related to the licensing and development services and purchase of equipment. As of December 31, 2024 and 2023,$0.2 million andzero, respectively, were owed to ANP by the Company in connection with these relationships. The Company also entered into an employee service agreement with ANP in April 2023,$0.1 million was recognized in revenue in each of the years ended December 31, 2024 and 2023, and insignificant amounts were owed by ANP in connection with the employee service agreement as of December 31, 2024 and 2023, respectively.
Note 15. Business Combinations
Inform Diagnostics
On April 26, 2022, the Company completed the acquisition of 100% of the outstanding equity of Inform Diagnostics, a leading national independent pathology laboratory based in Irving, Texas. Under the terms of the Agreement and Plan of Merger, dated April 16, 2022, or the Inform Merger Agreement, the total purchase price payable to the securityholders of Inform Diagnostics was approximately $170 million, as adjusted for closing cash, closing indebtedness, closing working capital, closing transaction expenses and other transaction matters. With the addition of Inform Diagnostics, the Company will further expand the Company’s genomic testing footprint and extend its test menu into breast pathology, gastrointestinal pathology, dermatopathology, urologic pathology, neuropathology, and hematopathology.
The financial results of Inform Diagnostics are included in the consolidated financial statements from the date of acquisition. The Company allocated the purchase price to tangible and identified intangible assets acquired and liabilities assumed based on estimated fair values. The following tables summarizes the consideration paid and the updated amounts of the assets acquired and liabilities assumed recognized at the acquisition date:
| Amounts | |
|---|---|
| (in thousands) | |
| Consideration | |
| Cash, net of cash received | $137,755 |
| Recognized amounts of identifiable assets acquired and liabilities assumed | |
| Net working capital | $(15,024) |
| Fixed assets | 20,242 |
| ROU assets - operating | 12,653 |
| ROU assets - finance | 1,183 |
| Deferred tax assets | 3,410 |
| Other long-term assets | 4,711 |
| Identifiable intangible assets | 57,060 |
| Operating lease liabilities | (12,653) |
| Finance lease liabilities | (1,183) |
| Income tax payable | (40) |
| Other long-term liabilities | (4,449) |
| Recognized amounts of identifiable assets acquired and liabilities assumed, net | 65,910 |
| Goodwill | 71,845 |
| Total | $137,755 |
The goodwill of $71.8 million arising from the acquisition is attributed to the expected synergies, assembled workforce, other benefits that will be potentially generated from the combination and deferred tax. The goodwill recognized is not deductible for tax purposes. The goodwill was subsequently fully impaired in December 2023. Refer to Note 17. Goodwill and Intangible Assets for more information.
The identifiable intangible assets acquired consisted of $54.0 million customer relationships with an estimated amortization life of 14 years, $2.7 million trade name with an estimated amortization life ofseven years, and $0.4 million in-place lease intangible asset to be amortized over the remaining lease term offive years.
The fair value of the customer relationship was estimated using the Multiperiod Excess Earnings Method, or MPEEM, of the income approach. Under the MPEEM, an intangible asset’s fair value is equal to the present value of the incremental after-tax cash flows attributable only to the subject intangible asset after deducting contributory asset charges. The incremental after-tax cash flows attributable to the customer relationships are then discounted to their present value at a risk-adjusted rate of return. The fair value of the trade name was estimated using the relief from royalty, or RFR, method. The RFR method estimates the portion of the Company’s earnings attributable to an intangible asset based on the royalty rate the Company would have paid for the use of the asset if it did not own it. The fair value of in-place lease intangible asset was estimated using the discounted cash flow under the income approach. The useful lives of the intangible assets for amortization purposes were determined by considering the period of expected cash flows used to measure the fair values of the intangible assets adjusted as appropriate for entity-specific factors including legal, regulatory, contractual, competitive, economic and other factors that may limit the useful life. The customer relationships and trade name are amortized on a straight-line basis over their estimated useful lives.
Revenue and operating loss from the Inform Diagnostics acquisition since the acquisition date were $83.6 million and $17.0 million, respectively, for year ended December 31, 2022, which are included in the accompanying Consolidated Statements of Operating.
The transaction costs associated with the acquisition of Inform Diagnostics consisted primarily of legal, regulatory and financial advisory fees of approximately $6.6 million for the year ended December 31, 2022. These transaction costs were expensed as incurred as general and administrative expense in the respective period.
Unaudited Pro Forma Financial Information
The following unaudited pro forma financial information summarizes the combined results of operations of Fulgent and Inform Diagnostics as if the companies had been combined as of the beginning of 2021. The pro forma financial information has been adjusted for the following:
Acquisition-related costs - Acquisition-related costs incurred by both Fulgent and Inform Diagnostics were excluded from the net income attributable to Fulgent, and total costs were $9.6 million for the year ended December 31, 2022.
Other adjustments to the net income attributable to Fulgent were $0.8 million for the year ended December 31, 2022. Other adjustments to revenue were $1.0 million for or the year ended December 31, 2022.
| Revenue | $659,386 |
|---|---|
| Net income attributable to Fulgent | $140,288 |
| Basic earnings per common share attributable to Fulgent | $4.66 |
| Diluted earnings per common share attributable to Fulgent | $4.53 |
Fulgent Pharma Holdings, Inc
On November 7, 2022, the Company completed the acquisition of 100% of the outstanding equity of Fulgent Pharma, a clinical-stage, therapeutic development company focused on perfecting drug candidates for treating a broad range of cancers. Under the terms of the Agreement and Plan of Merger, dated November 7, 2022, or the Pharma Merger Agreement, the total merger consideration was paid in a combination of cash, the Company’s common stock, or the Stock Consideration, and assumed RSUs subject to customary adjustments for closing cash, closing indebtedness, transaction expenses and other transaction matters. A portion of the Stock Consideration was held back for a duration of time after the closing of the transaction to satisfy certain indemnification obligations of the Pharma Stockholders as described in the Pharma Merger Agreement. The RSUs are subject to vesting over the four-year period immediately following the date of their original grant, subject to the holder’s continuing service. The integrated companies plan to offera vertically integrated solution to combat cancer with the potential to unlock significant long-term upsides for both the therapeutic and diagnostic businesses, while effectively managing risk.
The financial results of Fulgent Pharma are included in the consolidated financial statements from the date of acquisition. The Company allocated the purchase price to tangible and identified intangible assets acquired and liabilities assumed based on estimated fair values. The following tables summarizes the consideration paid and the updated amounts of the assets acquired and liabilities assumed recognized at the acquisition date:
The goodwill of $22.1 million arising from the acquisition is attributed to Fulgent Pharma’s rights to intellectual property, expected synergies, assembled workforce, and other benefits that will potentially be generated from the combination and deferred tax. The goodwill recognized is not deductible for tax purposes.
The identified intangible assets acquired consisted of $64.6 million in IPR&D. Fulgent Pharma has developed a novel nanoencapsulation and targeted therapy platform, which is designed to improve the therapeutic window and pharmacokinetic profile of new and existing cancer drugs. The lead drug candidate, FID-007, is currently being investigated in the United States to treat patients diagnosed with various cancers including H&N, ampullary, and pancreatic cancer. The Company has released preliminary data and completed enrollment for a Phase 1/1b dose escalation/expansion clinical trial for evaluation of FID-007 in treating patients diagnosed with advanced solid tumors. In this trial and to date, the Company has observed FID-007 to have a manageable safety profile and observed preliminary evidence of anti-tumor activity in heavily pre-treated patients across various tumor types. The fair value of the IPR&D was estimated using MPEEM. The method involves forecasting after-tax operating income from existing clients, subtracting the portions attributable to a contributory asset, and discounting the remaining earnings to present value. The useful life of IPR&D is indefinite.
Revenue and operating loss from the Fulgent Pharma acquisition since the acquisition date arezero and $0.8 million, respectively, which are included in the accompanying Consolidated Statements of Operations, for the year ended December 31, 2022.
The transaction costs associated with the acquisition of Fulgent Pharma consisted primarily of legal, regulatory and financial advisory fees of approximately $1.4 million for the year ended December 31, 2022. These transaction costs were expensed as incurred as general and administrative expense in the respective period.
The $5.0 million restricted cash received represents cash consideration payable pursuant to the share transfer agreement Fulgent Pharma entered prior to Fulgent Pharma acquisition date. The cash consideration was not paid as of Fulgent Pharma acquisition date and was included in noncurrent or non-operating liabilities in above table, and the cash consideration was subsequently paid in 2023.
Note 16. Stock Repurchase Program
In March 2022, the Company’s Board authorized a $250.0 million stock repurchase program. Under the stock repurchase program, the Company may repurchase shares from time to time in the open market or in privately negotiated transactions. The stock repurchase program has no expiration from the date of authorization. During the year ended December 31, 2024, the Company repurchased 10,000 shares of its common stock at an aggregate cost of$0.2 million under the stock repurchase program. During the year ended December 31, 2023, the Company repurchased 1.0 million shares of its common stock at an aggregate cost of$25.1 million under the stock repurchase program. During the year ended December 31, 2022, the Company repurchased 1.8 million shares of its common stock at an aggregate cost of$74.3 million under the stock repurchase program. As of December 31, 2024, a total of approximately$150.5 million remained available for future repurchases of its common stock under the stock repurchase program.
Note 17. Goodwill and Intangible Assets
Changes in the carrying amount of goodwill, net of impairment, by reporting unit for the years ended December 31, 2024 and 2023 are as follows:
| Laboratory Services | Therapeutic Development | |||
|---|---|---|---|---|
| December 31, 2024 | December 31, 2023 | December 31, 2024 | December 31, 2023 | |
| (in thousands) | ||||
| Balance at beginning of year | $— | $120,972 | $22,055 | $22,055 |
| Impairment | — | (120,234) | — | — |
| Foreign currency impact | — | (738) | — | — |
| Balance at the end of year | $— | $— | $22,055 | $22,055 |
The Company has identified its laboratory services business and its therapeutic development business as itstwo operating segments, and the Company determined that the operating segments represented thetwo reporting units. The Company tests for goodwill impairment at the reporting unit level on December 31st of each year and more frequently if events or circumstances indicate a potential impairment.
Laboratory Services
In 2023, the Company witnessed a continued decline in its share price and market capitalization which prompted a quantitative impairment analysis as of December 31, 2023, which led to the full impairment of the laboratory services goodwill.
Therapeutic Development
As of December 31, 2024, the Company performed an updated valuation for the fair values of its therapeutic development reporting unit and IPR&D due to significant developments in its clinical pipeline. FID-007 was previously in clinical Phase 1/1b as of the prior reporting period. The Company has released preliminary results for a Phase 1/1b clinical trial of FID-007 in patients diagnosed with advanced solid tumors and has begun enrollment of a Phase 2 clinical trial evaluating FID-007 in patients diagnosed with recurrent or metastatic H&N squamous cell carcinoma. The Company has also received clearance from the FDA to commence a Phase 1/1b clinical trial evaluating FID-022, a candidate using the same nano-drug delivery platform, in patients diagnosed with certain cancers. These advancements led to a revised assessment of the probability of success for each molecule, and resulted in an increase to estimated revenue projections.
The fair value of the Company’s therapeutic development reporting unitwas calculated using the income approach weighted at 100% with a WACC of 36%. Thefair value of the IPR&D was appraised using the income approach known as multi-period excess earnings method with a WACC of 36%.
Due to these changes, the fair values of the Company’s therapeutic development reporting unit and IPR&D increased significantly, and are now substantially higher than the carrying value recorded. The fair value of this reporting unit was $201.4 million and exceeded the carrying value of $54.8 million by approximately 268%, and the fair value of IPR&D was $202.7 million and exceeded the carrying value of $64.6 million by approximately 214%.
There can be no assurance that the estimates and assumptions management made for the purposes of the goodwill or IPR&D impairment analysis will prove to be accurate predictions of future performance. It is possible that the conclusions regarding impairment or recoverability of goodwill or intangible assets could change in future periods. Management will continue to monitor the therapeutic development reporting unit. For all IPR&D projects, there are major risks and uncertainties associated with the timely and successful completion of development and commercialization of these drug candidates, including the ability to confirm their efficacy based on data from clinical trials, the ability to obtain necessary regulatory approvals, and the ability to successfully complete these tasks within budgeted costs. The Company is not able to market a human therapeutic without obtaining regulatory approvals, and such approvals require completing clinical trials that demonstrate a drug candidate is safe and effective. In addition, the availability and extent of coverage and reimbursement from insurance payors, including government healthcare programs and private insurance plans, impact the revenues a product can generate. Consequently, the eventual realized value, if any, of these acquired IPR&D projects may vary from their estimated fair values.
Summaries of intangible assets balances as of December 31, 2024 and 2023 were as follows:
| Weighted-Average Amortization Period | December 31, 2024 | December 31, 2023 | |
|---|---|---|---|
| (in thousands) | |||
| Laboratory Services | |||
| Customer Relationships | 13 Years | $83,088 | $83,119 |
| Less: accumulated amortization | (19,079) | (12,586) | |
| Customer relationships, net | 64,009 | 70,533 | |
| Royalty-free technology | 10 Years | 5,069 | 5,211 |
| Less: accumulated amortization | (1,859) | (1,390) | |
| Royalty-free technology, net | 3,210 | 3,821 | |
| Trade name | 8 Years | 3,790 | 3,790 |
| Less: accumulated amortization | (1,401) | (906) | |
| Trade name, net | 2,389 | 2,884 | |
| Laboratory information system platform | 5 Years | 1,860 | 1,860 |
| Less: accumulated amortization | (1,271) | (899) | |
| Laboratory information system platform, net | 589 | 961 | |
| In-place lease intangible assets | 5 Years | 360 | 360 |
| Less: accumulated amortization | (186) | (116) | |
| In-place lease intangible assets, net | 174 | 244 | |
| Purchased patent | 10 Years | 27 | 28 |
| Less: accumulated amortization | (10) | (8) | |
| Purchased patent, net | 17 | 20 | |
| Total | 70,388 | 78,463 | |
| Therapeutic Development | |||
| In-process research & development | n/a | 64,590 | 64,590 |
| Total | 64,590 | 64,590 | |
| Total intangible assets, net | $134,978 | $143,053 | |
Acquisition-related intangibles included in the above tables are generally finite-lived and are carried at cost less accumulated amortization, except for IPR&D, which is related to the acquisition of Fulgent Pharma in 2022 and has an indefinite life until research and development efforts are completed or abandoned. All other finite-lived acquisition-related intangibles related to the business combinations are amortized on a straight-line basis over their estimated lives, which approximates the pattern in which the economic benefits of the intangible assets are expected to be realized.
Amortization of intangible assets was$8.0 million,$7.8 million and$6.5 million in 2024, 2023, and 2022, respectively.
Based on the carrying value of intangible assets recorded as of December 31, 2024, and assuming no subsequent impairment of the underlying assets, the annual amortization expense for intangible assets is expected to be as follows:
| Amounts | |
|---|---|
| (in thousands) | |
| Year ending December 31, | |
| 2025 | $7,955 |
| 2026 | 7,654 |
| 2027 | 7,196 |
| 2028 | 7,161 |
| 2029 | 6,904 |
| Thereafter | 33,518 |
| Total | $70,388 |
Note 18. Subsequent Event
Stock Repurchase Program
From January 1, 2025 through February 28, 2025, the Company repurchased 0.2 million shares of its common stock for an aggregate cost of$3.1 million at an average price of$16.61 per share under the stock repurchase program approved in March 2022. See Note 16, Stock Repurchase Program. As of February 28, 2025, a total of$147.4 million remained available for future repurchases of its common stock under the stock repurchase program.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.