VERACYTE INC
For the period ended Dec 31, 2023. Filed Feb 29, 2024.
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FY2023 · Filed Feb 29, 2024
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Notes to Consolidated Financial Statements
- Organization and Description of Business
Veracyte, Inc., or Veracyte, or the Company, is a global diagnostics company that provides clinicians with tests to diagnose cancer. Veracyte's tests are used by clinicians for diagnostic, prognostic and treatment decisions.
Veracyte was incorporated in the state of Delaware on August 15, 2006, as Calderome, Inc. Calderome operated as an incubator until early 2008. On March 4, 2008, the Company changed its name to Veracyte, Inc. The Company’s headquarters are in South San Francisco, California, and it also has operations in San Diego, California; Austin, Texas; and Marseille, France. In March 2021, the Company acquired Decipher Biosciences and, in August 2021, the Company acquired HalioDx SAS and HalioDx Inc., historically a wholly owned subsidiary of HalioDx SAS.
The Company currently offers tests in thyroid cancer (Afirma); prostate cancer (Decipher Prostate); breast cancer (Prosigna); bladder cancer (Decipher Bladder); and interstitial lung diseases (Envisia). The Company’s Percepta Nasal Swab test is being run in its CLIA lab in support of clinical studies and its test for lymphoma is in development as a companion diagnostic.
The Company serves global markets with two complementary models. In the United States, it offers laboratory developed tests, or LDTs, through its centralized, Clinical Laboratory Improvement Amendments of 1988, or CLIA, certified laboratories in South San Francisco and San Diego, California, supported by its cytopathology expertise in Austin, Texas. Additionally, primarily outside of the United States, the Company provides its Prosigna test to patients through distribution to laboratories and hospitals that can perform the tests locally as an IVD test that runs on the nCounter Analysis System.
In February 2024, the Company acquired C2i Genomics, Inc., or C2i, a minimal residual disease, or MRD, detection company. Refer to Note 13 Subsequent Event for additional information.
- Summary of Significant Accounting Policies
Basis of Presentation
The Company's consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States, or U.S. GAAP. The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.
Reclassifications
Certain prior period balances have been reclassified to conform to current period presentation of the Company’s consolidated financial statements and accompanying notes. Such reclassifications have no effect on previously reported results of operations, accumulated deficit, subtotals of operating, investing or financing cash flows or consolidated balance sheet totals; however, for the year ended December 31, 2022, the Company reclassified $3.3 million of impairment of long-lived assets from the general and administrative expense caption in the consolidated statements of operations.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent liabilities as of the date of the consolidated financial statements and the reported amounts of revenue and expenses during the reporting period. Significant items subject to such estimates include: revenue recognition; the useful lives of property, plant and equipment; the recoverability of long-lived assets; the incremental borrowing rates for leases; accounting for acquisitions; the estimation of the fair value of intangible assets and contingent consideration; stock based compensation; income tax uncertainties, including a valuation allowance for deferred tax assets; credit related losses on investments; and allowance for credit losses and contingencies. The Company bases these estimates on historical and anticipated results, trends, and various other assumptions that the Company believes are reasonable under the circumstances, including assumptions as to future events. These estimates form the basis for making judgments about the carrying values of assets and liabilities and recorded revenue and expenses that are not readily apparent from other sources. Actual results could differ from those estimates and assumptions.
Liquidity
The Company has incurred net losses since its inception and as of December 31, 2023, the Company had an accumulated deficit of $468.1 million. The Company believes its cash and cash equivalents of $216.5 million as of December 31, 2023, and its revenue from sales in 2024 will be sufficient to meet its anticipated cash requirements through at least February 2025.
Concentrations of Credit Risk and Other Risks and Uncertainties
The majority of the Company’s cash and cash equivalents are deposited with two major financial institutions in the United States. Deposits in these institutions may exceed the amount of insurance provided on such deposits. The Company has not realized any losses on its deposits of cash and cash equivalents other than exchange rate losses related to foreign currency denominated accounts.
Several of the components of the Company's sample collection kits and test reagents, and the nCounter Analysis system and related diagnostic kits, are obtained from single-source suppliers. If these single-source suppliers fail to satisfy the Company's requirements on a timely basis, or are unable to provide the Company with reagents that perform to specifications, the Company could suffer delays in being able to deliver its diagnostic solutions, suffer a possible loss of revenue, or incur higher costs, any of which could adversely affect its operating results.
Through December 31, 2023, the Company has derived most of its revenue from the sale of Decipher and Afirma testing. To date, Decipher and Afirma testing have been delivered primarily to physicians in the United States.
The Company is also subject to credit risk from its accounts receivable related to its sales. Credit risk for accounts receivable from testing revenue is incorporated in testing revenue accrual rates as the Company assesses historical collection rates and current developments to determine accrual rates and amounts the Company will ultimately collect. The Company generally does not perform evaluations of customers’ financial condition for testing revenue and generally does not require collateral. The Company assesses credit risk and the amount of accounts receivable the Company will ultimately collect for product, biopharmaceutical and other revenue based on collection history, current developments and credit worthiness of the customer. The estimate of credit losses is not material at December 31, 2023.
The Company's total third-party payers and other customers in excess of 10% of total revenue and their related revenue as a percentage of total revenue were as follows:
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Medicare | 31% | 31% | 30% |
| UnitedHealthcare | 10% | 10% | 10% |
| 41% | 41% | 40% | |
The Company's significant third-party payers in excess of 10% of total accounts receivable and their related accounts receivable balance as a percentage of total accounts receivable were as follows:
| As of December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Medicare | 20% | 14% |
| UnitedHealthcare | 9% | 10% |
Cash Equivalents
The Company considers demand deposits in a bank, money market funds and highly liquid investments with an original maturity of 90 days or less to be cash equivalents.
Short-Term Investments
The Company's short-term investments consist of United States treasury securities and time deposits with a bank with maturities at the time of purchase that were between 90 days and one year. The Company classifies these investments as held-to-maturity debt securities, which are reported at amortized cost. Discounts or premiums from the purchase of the securities are recognized as a component of interest income in other income (loss), net in the consolidated statements of operations. Investments are initially recorded net of an allowance for expected credit losses, if any, which are remeasured each period and any impairments are recognized as an expense. Unrealized gains and losses are not recognized in income. As of both December 31, 2023 and December 31, 2022, no allowances for expected credit losses had been recorded and there have been no impairment or credit losses on the Company's short term investments.
Restricted Cash
The Company had deposits of $0.9 million and $0.7 million included in long-term assets as of December 31, 2023 and December 31, 2022, respectively, restricted from withdrawal and held by banks in the form of collateral for irrevocable standby letters of credit held as security for the Company's leases.
Acquisitions
The Company first determines whether a set of assets acquired and liabilities assumed constitute a business and should be accounted for as a business combination. If the assets acquired are not a business, the Company accounts for the transaction as an asset acquisition. Business combinations are accounted for by using the acquisition method of accounting. Under the acquisition method, assets acquired, and liabilities assumed are recorded at their respective fair values as of the acquisition date in the Company's consolidated financial statements. The estimated fair value of intangible assets acquired are based on discounted cash flows utilizing certain assumptions including revenues (such as projected testing volumes, growth rates), discount rates and expected economic life/obsolescence factors of the respective assets. The excess of the fair value of consideration transferred over the fair value of the net assets acquired is recorded as goodwill. Contingent consideration obligations incurred in connection with a business combination are recorded at fair value on the acquisition date and remeasured at each subsequent reporting period until the related contingencies are resolved, with the resulting changes in fair value recorded in general and administrative expense in the consolidated statements of operations.
Supplies consists of materials and reagents consumed in the performance of testing services. Inventory consists of raw materials consumed in the contract manufacturing process as well as finished and semi-finished components used in the assembly of diagnostic kits related to product sales. Inventory is stated at the lower of cost or net realizable value on a weighted average basis. The Company periodically analyzes supply and inventory levels and expiration dates, and writes down supply or inventory that has become obsolete, that has a cost basis in excess of its net realizable value, or in excess of expected sales requirements as cost of revenue. The Company records an allowance for excess or obsolete supplies and inventory using an estimate based on historical trends and evaluation of near-term expirations.
Property and Equipment
Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, generally between three andfive years. Leasehold improvements are amortized using the straight-line method over the shorter of the estimated useful life of the asset or the term of the lease. Maintenance and repairs are charged to expense as incurred, and improvements and betterments are capitalized. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the balance sheet and any resulting gain or loss is reflected in the statements of operations in the period realized.
Leases
The Company determines if an arrangement is, or contains, a lease at inception. Operating leases are included in right-of-use assets - operating leases and operating lease liabilities in the consolidated balance sheets, representing the right to use an underlying asset for the lease term and the obligation to make lease payments arising from the lease. Right-of-use, or ROU, assets and lease liabilities are recognized at commencement based on the present value of lease payments over the lease term. The Company uses its incremental borrowing rate based on the estimated rate of interest for collateralized borrowing over a similar term of the lease payments. The ROU assets also includes any lease payments made and is adjusted for lease incentives. Lease terms may include options to extend or terminate the lease which are recognized when it is reasonably certain that the Company will exercise that option. Lease expense is recognized on a straight-line basis over the lease terms. Lease and non-lease components are accounted for as a single lease component. Financing leases are immaterial and are included in property and equipment, net and other liabilities in the consolidated balance sheets. Leases with terms of 12 months or less are not recorded on our balance sheet.
Finite-lived Intangible Assets
Finite-lived intangible assets consist of intangible assets acquired as part of business combinations. The Company amortizes finite-lived intangible assets using the straight-line method over their estimated useful lives of 4 to 15 years, based on management's estimate of the period over which their economic benefits will be realized, product life and patent life. The Company tests these finite-lived intangible assets for impairment when events or circumstances indicate a reduction in the fair value below their carrying amounts. The Company recorded impairment charges of $66.9 million and $3.3 million for the years ended December 31, 2023 and 2022 andno impairment charge for the year ended December 31, 2021. See Note 5 Balance Sheet Components for more information on impairment testing.
Indefinite-lived Intangible Assets
Indefinite-lived intangible assets consist of in-process research and development, or IPR&D, acquired as part of business combinations. The IPR&D is not amortized until it becomes commercially viable and placed in service. At the time when the intangible assets are placed in service the Company will determine a useful life. The Company also tests these indefinite-lived intangible assets for impairment when events or circumstances indicate a reduction in the fair value below their carrying amounts. There wasno impairment of indefinite-lived intangible assets for the years ended December 31, 2023, 2022 or 2021.
Goodwill, is reviewed for impairment on an annual basis or more frequently if events or circumstances indicate that it may be impaired. The Company's goodwill evaluation is based on both qualitative and quantitative assessments regarding the fair value of goodwill relative to its carrying value. The Company has determined that it operates in a single segment and has a single reporting unit associated with the development and commercialization of diagnostic products. In the event the Company determines that it is more likely than not the carrying value of the reporting unit is higher than its fair value, quantitative testing is performed comparing recorded values to estimated fair values. If impairment is present, the impairment loss is measured as the excess of the recorded goodwill over its implied fair value. There wasno impairment of goodwill for the years ended December 31, 2023, 2022 or 2021.
Fair Value of Financial Instruments
The carrying amounts of certain financial instruments including cash and cash equivalents, accounts receivable, prepaid expenses and other current assets, accounts payable and accrued liabilities approximate fair value due to their relatively short maturities.
See Note 6. Fair Value Measurements for further information on the fair value of the Company’s financial instruments.
Revenue Recognition
The Company recognizes revenue in accordance with the provisions of ASC 606, Revenue from Contracts with Customers, or ASC 606. This process involves identifying the contract with a customer, determining the performance obligations in the contract, determining the contract price, allocating the contract price to the distinct performance obligations in the contract, and recognizing revenue when the performance obligations have been satisfied. A performance obligation is considered distinct from other obligations in a contract when it provides a benefit to the customer either on its own or together with other resources that are readily available to the customer and is separately identified in the contract. Performance obligations are considered satisfied once the Company has completed a service or transferred control of a product to the customer.
In arrangements involving more than one service or good, each required service or good is evaluated to determine whether it qualifies as a distinct performance obligation based on whether (i) the customer can benefit from the service or good either on its own or together with other resources that are readily available and (ii) the service or good is separately identifiable from other promises in the contract. The consideration under the arrangement is then allocated to each separate distinct performance obligation based on its respective relative stand-alone selling price. The estimated selling price of each deliverable reflects the Company's best estimate of what the selling price would be if the deliverable was regularly sold by the Company on a stand-alone basis or using an adjusted market assessment approach if selling price on a stand-alone basis is not available. The consideration allocated to each distinct performance obligation is recognized as revenue when control is transferred which may be at a point in time or over time.
The Company recognizes revenue from the sale of tests performed for customers, including patients and institutions, at the time test results are reported to physicians. Most tests requested by customers are sold without a written agreement; however, the Company determines that an implied contract exists with its customers for whom a physician will order the test. The Company identifies each sale of our test to a customer as a single performance obligation. A stated contract price does not exist and the transaction price for each implied contract with a customer represents variable consideration. The Company estimates the variable consideration under the portfolio approach and considers the historical reimbursement data from third-party commercial and governmental payers and patients, as well as known or anticipated reimbursement trends not reflected in the historical data. The Company monitors the estimated amount to be collected in the portfolio at each reporting period based on actual cash collections in order to assess whether a revision to the estimate is required. Both the estimate and any subsequent revision contain uncertainty and require the use of significant judgment in the estimation of the variable consideration and application of the constraint for such variable consideration. The Company analyzes its actual cash collections over the expected reimbursement period and compares it with the estimated variable consideration for each payer group and any difference is recognized as an adjustment to estimated revenue after the expected reimbursement period, subject to assessment of the risk of future revenue reversal. For the years ended December 31, 2023, 2022 and 2021, the Company recorded $7.8 million, $3.1 million, and $1.1 million as revenue, respectively, resulting from cash collections exceeding the estimated variable consideration related to tests reported in previous years, including revenue received from successful appeals of reimbursement denials, net of recoupments.
The Company's products consist of the Prosigna breast cancer assay, the nCounter Analysis System, related diagnostic kits and services. Product revenue from diagnostic kits is generally recognized upon shipment. Product revenue from instruments is generally recognized when the instrument is ready for use by the end customer. Shipping and handling costs incurred for product shipments are included in product revenue. Revenue is presented net of the taxes that are collected from customers and remitted to governmental authorities.
The Company enters into arrangements to license or provide access to its assets or services, including clinical services, research and development, contract manufacturing and development, as well as other services, which are classified under biopharmaceutical and other revenue. In prior years the Company also entered into arrangements for testing services. Such arrangements may require the Company to deliver various rights, manufactured diagnostic test kits, services and/or samples, including intellectual property rights/licenses and biopharmaceutical research and development services. The Company receives consideration in the form of upfront license fees; payments on delivery of data, test results or manufactured products; costs of service plus margin; and development and commercial performance milestone payments.
The Company develops estimates and assumptions that require judgment to determine the underlying stand-alone selling price for each performance obligation which determines how the transaction price is allocated among the performance obligations. The estimation of the stand-alone selling price may include independent evidence of market price, forecasted revenue or costs, development timelines, discount rates, and probabilities of technical and regulatory success. The Company evaluates each performance obligation to determine if the obligation can be satisfied at a point in time or over time, and it measures the services delivered to the collaborative partner which are periodically reviewed based on the progress of the related program. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time. The effect of any change made to an estimated input component and, therefore revenue or expense recognized, would be recorded as a change in estimate. In addition, variable consideration must be evaluated to determine if it is constrained and, therefore, excluded from the transaction price.
At the inception of each arrangement that includes milestone payments (variable consideration), the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price. Milestone payments that are not within either party’s control, such as non-operational developmental and regulatory approvals, are generally not considered probable of being achieved until those approvals are received. At the end of each reporting period, the Company re-evaluates the probability of achievement of milestones that are within either party’s control, such as operational developmental milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and earnings in the period of adjustment. Revisions to the Company’s estimate of the transaction price may also result in negative revenue and earnings in the period of adjustment. One collaboration arrangement with milestone payments falls under the scope of ASC Topic 808, Collaborative Arrangements, or ASC 808. These milestone payments are recognized in the same manner as milestone payments from customers and are classified under biopharmaceutical and other revenue.
Accounts receivable from biopharmaceutical and other revenue was $6.0 million and $9.3 million at December 31, 2023 and 2022, respectively. There was $2.0 million and $2.6 million of deferred revenue related to these agreements at December 31, 2023 and 2022, respectively.
Revenue included in biopharmaceutical and other revenue for the years ended December 31, 2023, 2022 and 2021 was as follows (in thousands of dollars):
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Biopharmaceutical revenue | $13,874 | $26,341 | $12,613 |
| Contract manufacturing and testing | 5,047 | 7,019 | 3,255 |
| Collaboration milestones | — | — | 4,000 |
| Total | $18,921 | $33,360 | $19,868 |
Cost of Testing Revenue
The components of the Company's cost of testing services are laboratory expenses, sample collection expenses, compensation expense, license fees and royalties, depreciation, other expenses such as equipment and laboratory supplies, and allocations of facility and information technology expenses. Costs associated with performing tests are expensed as the test is processed regardless of whether and when revenue is recognized with respect to that test.
Cost of Product Revenue
Cost of product revenue consists primarily of costs of purchasing instruments and diagnostic kits from third-party contract manufacturers, installation, service and packaging and delivery costs, and the Company's internal labor expenses. In addition, cost of product includes royalty costs for licensed technologies included in the Company's products. Cost of product revenue for instruments and diagnostic kits is recognized in the period the related revenue is recognized. Shipping and handling costs incurred for product shipments are included in cost of product in the consolidated statements of operations.
Cost of Biopharmaceutical and Other Revenue
Cost of biopharmaceutical and other revenue consists of costs of performing activities under arrangements that require the Company to license or provide access to its assets or services, including clinical services, research and development, contract manufacturing and previously included contract testing services on behalf of a customer.
Research and Development
Research and development expenses include expenses incurred to collect clinical samples and conduct clinical studies to develop and support its products and pipeline, as well as develop future technology. These expenses consist of compensation expenses, direct research and development expenses such as laboratory supplies and costs associated with setting up and conducting clinical studies at domestic and international sites, professional fees, depreciation and amortization, other miscellaneous expenses and allocation of facility and information technology expenses. The Company expenses all research and development costs in the periods in which they are incurred.
Income Taxes
The Company accounts for income taxes under the liability method. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to affect taxable income. Valuation allowances are established when necessary to reduce deferred tax assets to the amounts expected to be realized.
The Company assesses all material positions taken in any income tax return, including all significant uncertain positions, in all tax years that are still subject to assessment or challenge by relevant taxing authorities. The Company's assessment of an uncertain tax position begins with the initial determination of the position's sustainability and is measured at the largest amount of benefit that is more-likely-than-not of being realized upon ultimate settlement. As of each balance sheet date, unresolved uncertain tax positions must be reassessed, and the Company will determine whether (i) the factors underlying the sustainability assertion have changed and (ii) the amount of the recognized tax benefit is still appropriate. The recognition and measurement of tax benefits requires significant judgment. Judgments concerning the recognition and measurement of a tax benefit may change as new information becomes available.
Stock-based compensation expense for stock options issued to employees and non-employees is measured based on the grant-date fair value of the award. The fair value of each stock option is estimated on the date of grant using the Black-Scholes option-pricing model. Stock-based compensation expense for restricted stock units, or RSUs, is measured based on the fair value of the award, which is determined based upon the closing price of the Company’s common stock on the date of the grant. The Company grants performance-based stock units, or PSUs, to certain employees which vest upon the achievement of certain performance conditions, subject to the employees’ continued service with the Company. The probability of vesting is assessed at each reporting period and compensation cost is adjusted based on this probability assessment.
The Company recognizes compensation costs on a straight-line basis for all employee stock-based compensation awards that are expected to vest over the requisite service period of the awards, which is generally the awards' vesting period. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.
Net Loss per Common Share
Basic net loss per common share is calculated by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration of common stock equivalents. Diluted net loss per common share is computed by dividing net loss attributable to common stockholders by the weighted-average number of common share equivalents outstanding for the period determined using the treasury stock method. Potentially dilutive securities consisting of options to purchase common stock, RSUs, PSUs and shares subject to purchase under the Company's employee stock purchase plan are considered to be common stock equivalents and were excluded from the calculation of diluted net loss per common share because their effect would be anti-dilutive for all periods presented.
French Research Tax Credits
The French research tax credits (crédit d’impôt recherche, or CIR) are generated by the Company’s wholly owned subsidiary, Veracyte SAS, in connection with its research efforts performed in Marseille, France. The Company recognizes other income from the CIR over time based on when the research and development expenses are incurred. As of December 31, 2023, $4.7 million of CIR are recorded in prepaids and other current assets on the consolidated balance sheets and $4.6 million is included in other assets.
Foreign Currency Translation
The functional currency of the Company’s foreign subsidiary, Veracyte SAS, is the Euro. Assets and liabilities denominated in foreign currencies are translated to U.S. dollars using the exchange rates at the balance sheet date. Foreign currency translation adjustments are recorded as a component of accumulated other comprehensive income (loss) within stockholders’ equity. Revenues and expenses from the Company’s foreign subsidiaries are translated using the monthly average exchange rates in effect during the period in which the transactions occur. Foreign currency transaction gains and losses are recorded in other income, net, on the consolidated statements of operations.
Comprehensive Loss
Comprehensive loss is the change in stockholders’ equity from transactions and other events and circumstances other than those resulting from investments by stockholders and distributions to stockholders. The Company's comprehensive loss includes our net loss and gains and losses from the foreign currency translation of the assets and liabilities of our foreign subsidiaries.
Segment Reporting
The chief operating decision maker for the Company is the Chief Executive Officer, who reviews financial information presented on a consolidated basis for purposes of allocating resources and assessing financial performance. The Company has a single reporting unit associated with the development and commercialization of diagnostic products and biopharmaceutical services.
Revenue by geographic region based on the customer billing address was as follows (in thousands):
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| United States | $334,525 | $262,923 | $200,982 |
| International | 26,526 | 33,613 | 18,532 |
| Total revenue | $361,051 | $296,536 | $219,514 |
Substantially all of the Company’s long-lived assets were located in the United States as of December 31, 2023 and 2022.
Recent Accounting Pronouncements
Recently adopted accounting pronouncements
In October 2021, the FASB issued ASU 2021-08, Business Combinations (Topic 805): Accounting for Contract Assets and Contract Liabilities from Contracts with Customers, which requires entities to recognize and measure contract assets and contract liabilities acquired in a business combination in accordance with ASC 2014-09, Revenue from Contracts with Customers (Topic 606). The update will generally result in an entity recognizing contract assets and contract liabilities at amounts consistent with those recorded by the acquiree immediately before the acquisition date rather than at fair value. The new standard is effective on a prospective basis for fiscal years beginning after December 15, 2022, with early adoption permitted. The Company adopted this guidance in 2023 and such adoption had no material impact on its consolidated financial statements and related disclosures.
Recently issued accounting pronouncements not yet adopted
In December 2023, the FASB issued ASU No. 2023-09, Improvements to Income Tax Disclosures (Topic 740). This update requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as additional information on income taxes paid. This ASU is effective on a prospective basis for annual periods beginning after December 15, 2024. Early adoption is also permitted for annual financial statements that have not yet been issued or made available for issuance. This ASU will result in the required additional disclosures being included in the Company's consolidated financial statements, once adopted.
- Net Loss Per Share
The following outstanding common stock equivalents have been excluded from diluted net loss per common share for the years ended December 31, 2023, 2022 and 2021 because their inclusion would be anti-dilutive:
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Shares of common stock subject to outstanding options | 3,820,878 | 3,923,882 | 3,754,807 |
| Employee stock purchase plan | 34,874 | 42,733 | 21,158 |
| Restricted stock units | 2,714,324 | 2,003,509 | 1,106,938 |
| Total common stock equivalents | 6,570,076 | 5,970,124 | 4,882,903 |
- Business Combinations
HalioDx
On August 2, 2021, the Company acquired 100% of the equity interests of HalioDx, or the HalioDx Acquisition. The HalioDx Acquisition gave the Company the capabilities and expertise to manufacture its own IVD test kits for use on the nCounter Analysis System. The acquisition also deepened the Company's scientific expertise and capabilities in the rapidly growing area of immuno-oncology, further strengthening its offerings for biopharmaceutical and other partners. The consideration to acquire HalioDx was $319.6 million, comprised of $147.1 million in the form of 3.3 million shares of the Company’s common stock based on the Company's share price on the closing date, $4.2 million in liabilities, and the remainder in cash. The measurement period concluded in August 2022 and certain adjustments had been recorded as net increases to goodwill totaling $0.2 million and did not impact the consolidated statements of operations.
Decipher Biosciences
On March 12, 2021, the Company acquired 100% of the equity interests of Decipher Biosciences, a privately-held company developing diagnostic tests in urologic cancers, for approximately $594.7 million, or the Decipher Acquisition. The Decipher Acquisition advanced the Company's objective to improve the lives of patients through innovations in genomic technology tailored for diagnostic, prognostic, and treatment decisions related to urologic cancers. The measurement period concluded in March 2022, andno adjustments were recorded during the year ended December 31, 2023
Related Party Transactions
Dr. Robert S. Epstein, M.D., M.S., a member of the Company’s board of directors, and Dr. Tina S. Nova, Ph.D., formerly a member of the Company’s board of directors, served on the board of directors of Decipher Biosciences prior to the acquisition, with Dr. Nova additionally serving as President and Chief Executive Officer of Decipher Biosciences. Pursuant to Veracyte's related party transactions policy, Dr. Nova and Dr. Epstein recused themselves from all discussions of its board of directors related to the Decipher Acquisition, and the Decipher Acquisition was approved by each of the non-interested members of the board of directors. In connection with the Decipher Acquisition, certain Decipher Biosciences equity awards held by Dr. Nova and Dr. Epstein were fully-accelerated and certain incentive bonus payments were made to Dr. Nova pursuant to a management incentive plan established by the Decipher Biosciences board of directors, resulting in payments of approximately $26.5 million and $1.4 million to each of them, respectively. Dr. Nova resigned from Veracyte’s board of directors and now serves as Veracyte's General Manager, Urology. Dr. Epstein continues to serve on Veracyte’s board of directors.
- Balance Sheet Components
As of December 31, 2023 and 2022, supplies and inventory consisted of $12.2 million and $10.2 million, respectively, of lab supplies and reagents consumed in the performance of testing services, and $4.0 million and $4.1 million, respectively, of inventory related to raw materials consumed in contract manufacturing process, as well as finished and semi-finished components used in the assembly of diagnostic kits related to product sales.
Property and Equipment, Net
Property and equipment consisted of the following (in thousands of dollars):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Leasehold improvements | $10,306 | $9,740 |
| Laboratory equipment | 26,816 | 21,159 |
| Computer equipment | 3,451 | 2,245 |
| Software, including software developed for internal use | 6,865 | 6,647 |
| Furniture and fixtures | 3,541 | 3,306 |
| Construction-in-process | 2,465 | 587 |
| Total property and equipment, at cost | 53,444 | 43,684 |
| Accumulated depreciation | (32,860) | (25,982) |
| Total property and equipment, net | $20,584 | $17,702 |
Depreciation expense was $6.6 million, $4.6 million and $3.6 million for the years ended December 31, 2023, 2022 and 2021, respectively.
Intangible Assets, Net
Intangible assets include finite-lived product technology, customer relationships, licenses and trade names and indefinite-lived in-process research and development. Intangible assets consisted of the following (in thousands of dollars):
| December 31, 2023 · December 31, 2022 · Weighted Average Remaining Amortization Period (Years) | |||||||
|---|---|---|---|---|---|---|---|
| Gross Carrying Amount · Accumulated Amortization · Net Carrying Amount · Gross Carrying Amount · Accumulated Amortization · Net Carrying Amount | |||||||
| Percepta product technology | $16,000 | $(9,333) | $6,667 | $16,000 | $(8,267) | $7,733 | 6 |
| Prosigna product technology | 4,120 | (1,122) | 2,998 | 4,120 | (847) | 3,273 | 11 |
| Prosigna customer relationships | 2,430 | (1,985) | 445 | 2,430 | (1,499) | 931 | 1 |
| nCounter Dx license | — | — | — | 46,880 | (9,636) | 37,244 | |
| LymphMark product technology | 990 | (577) | 413 | 990 | (436) | 554 | 3 |
| Decipher product technology | 90,000 | (25,234) | 64,766 | 90,000 | (16,234) | 73,766 | 7 |
| Decipher trade names | 4,000 | (2,243) | 1,757 | 4,000 | (1,443) | 2,557 | 2 |
| HalioDx developed technology | 1,435 | (346) | 1,089 | 39,724 | (5,899) | 33,825 | 8 |
| HalioDx customer relationships | 2,760 | (1,331) | 1,429 | 4,602 | (1,144) | 3,458 | 3 |
| HalioDx customer backlog | 4,258 | (2,529) | 1,729 | 6,528 | (2,303) | 4,225 | 2 |
| Total finite lived intangibles | 125,993 | (44,700) | 81,293 | 215,274 | (47,708) | 167,566 | 6.9 |
| In-process research and development | 7,300 | — | 7,300 | 7,300 | — | 7,300 | |
| Total intangible assets | $133,293 | $(44,700) | $88,593 | $222,574 | $(47,708) | $174,866 | |
During 2023, the Company concluded it had a triggering event requiring assessment of impairment for certain of its long-lived assets in conjunction with management’s decision to adopt a multi-platform IVD strategy. Management believes that a multi-platform strategy will enable the Company to more rapidly reach more patients globally with its tests. As a result, the Company reviewed the long-lived assets for impairment and recorded a $34.9 million impairment charge associated with its nCounter Dx license finite-lived intangible asset. In addition, during 2023, the Company concluded that, due to a significant change in the business environment, it had a triggering event requiring assessment of impairment for certain of its long-lived assets related to biopharma assets. As a result, the Company recorded a $32.0 million impairment charge associated with its HalioDx biopharmaceutical services developed technology, customer relationships and customer backlog finite-lived intangible assets. Both impairments are recorded within impairment of long-lived assets on the consolidated statement of operations.
During the three months ended June 30, 2022, the Company concluded it had a triggering event requiring assessment of impairment for certain of its long-lived assets in conjunction with management’s decision to cease commercialization efforts related to the Company’s stand-alone Immunoscore Colon Dx commercial offering. As a result, the Company reviewed the long-lived assets for impairment and recorded a $3.3 million impairment charge associated with its HalioDx Immunoscore Colon Dx developed technology finite-lived intangible asset within impairment of long-lived assets on the consolidated statement of operations.
The Company assessed the impairment of the intangible assets using an income approach which involved significant unobservable inputs, which are Level III inputs, including revenue projections and cash flow projections. This method is consistent with the methods the Company employed in prior periods to value other long-lived assets.
Amortization of the finite-lived intangible assets is recognized on a straight-line basis. Amortization of $20.6 million, $21.4 million and $16.0 million was recognized for the years ended December 31, 2023, 2022, and 2021, respectively.
The estimated future aggregate amortization expense as of December 31, 2023 is as follows (in thousands of dollars):
| Year Ending December 31, | Amounts |
|---|---|
| 2024 | $13,472 |
| 2025 | 12,658 |
| 2026 | 11,096 |
| 2027 | 10,485 |
| 2028 | 10,485 |
| Thereafter | 23,097 |
| Total | $81,293 |
Goodwill was $703.0 million and $695.9 million as of December 31, 2023 and 2022, respectively. The changes in the carrying amounts of goodwill during the year ended December 31, 2023 were due to foreign currency translation. The Company hasnot recorded any impairment related to goodwill.
Accrued Liabilities
Accrued liabilities consisted of the following (in thousands of dollars):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Accrued compensation expense | $26,430 | $30,637 |
| Accrued other | 11,997 | 7,137 |
| Total accrued liabilities | $38,427 | $37,774 |
- Fair Value Measurements
The Company records certain of its financial assets and liabilities at fair value. The accounting guidance for fair value provides a framework for measuring fair value and clarifies the definition of fair value. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows:
Level I: Inputs which include quoted prices in active markets for identical assets and liabilities;
Level II: Inputs other than Level I that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and
Level III: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
The carrying amounts of certain financial instruments of the Company, including cash and cash equivalents, prepaid expenses and other current assets, accounts payable and accrued liabilities, approximate fair value due to their relatively short maturities. The fair value of the Company’s financial assets includes money market funds and deposits for leases of the Company's facilities. Money market funds, included in cash and cash equivalents in the accompanying consolidated balance sheets, was $1.4 million and $131.2 million as of December 31, 2023 and 2022, respectively, and are Level I assets as described above. The deposits for the leases, included in restricted cash, was $0.9 million and $0.7 million as of December 31, 2023 and 2022 respectively, and are Level I assets as described above. There were no transfers between Levels 1, 2 or 3 for the years ended December 31, 2023, 2022, and 2021.
As part of the Company’s agreement to acquire the exclusive global diagnostic license to the nCounter Analysis System, the Company may pay up to an additional $10.0 million in cash, contingent upon first achievement or occurrence, by or on behalf of the Company, of the commercial launch of the first, second and third diagnostic tests for use on the nCounter multiplex analysis system. This contingency was valued at $6.1 million as of the acquisition date and is remeasured to fair value at each reporting date until the contingent consideration is settled, with the corresponding changes included in general and administrative expense in the Company's consolidated statements of operations. During the three months ended September 30, 2023, the Company decided to adopt a multi-platform IVD strategy that will enable it to more rapidly reach more patients globally with its tests and therefore move away from commercializing several IVD tests on the nCounter Analysis System. As a result, as of December 31, 2023, this contingency was remeasured to $3.2 million and a reversal of expense of $5.4 million was recorded for the year ended December 31, 2023. As of December 31, 2022, this contingency was remeasured to $8.6 million. For the years ended December 31, 2022, and 2021 expenses of $0.2 million and $0.8 million, respectively, were recorded. As of December 31, 2023, the achievement of one of the milestones is forecasted to occur within the next 12 months. As a result, $2.7 million of the contingent consideration is included in short term liabilities at December 31, 2023. The fair value of the contingent consideration includes inputs that are not observable in the market and thus represents a Level III financial liability. The estimation of the fair value of the contingent consideration is based on the present value of the expected payments calculated by assessing the likelihood of when the related milestones would be achieved and estimating the Company's borrowing rate. These estimates form the basis for making judgments about the carrying value of the contingent consideration that are not readily apparent from other sources. Changes to the forecasts for the achievement of the milestones and the borrowing rate can significantly affect the estimated fair value of the contingent consideration. As of December 31, 2023 and 2022, the Company calculated the estimated fair value of the milestones using the following significant unobservable inputs:
| Value or Range (Weighted-Average) | ||
|---|---|---|
| Unobservable input | December 31, 2023 | December 31, 2022 |
| Discount rate | 6.8% | 8.3% |
| Probability of achievement | 10% - 80% (69%) | 80% - 100% (94%) |
Short-Term Investments Held-to-Maturity
The Company's short-term investments consist of United States treasury securities with maturities, at the time of purchase, that were between 90 days and one year. The Company classifies these investments as held-to-maturity debt securities, which are reported at amortized cost, and are Level I assets as described above. As of December 31, 2023, the Company heldno short-term investments. As of December 31, 2022, short-term investments comprised United States treasury bills recorded at amortized cost of $24.6 million, with fair values of approximately $24.6 million. As of December 31, 2022, gross unrealized gains on short-term investments were insignificant. As part of its banking partner diversification efforts, the Company sold $40.0 million United States treasury bills with an amortized cost of $39.8 million, netting proceeds of $39.8 million and realized a gross gain of $13 thousand during the year ended December 31, 2023. No realized gains or losses on short-term investments were recognized in 2022.
- Commitments and Contingencies
Operating Leases
The Company leases office and laboratory facilities in South San Francisco and San Diego, California; Austin, Texas; Marseille, France; and Richmond, Virginia, and leases certain equipment under various non-cancelable lease agreements. The lease terms extend to October 2030 and contain extension of lease term and expansion options. The leases have a weighted average remaining lease term of 2.7 years as of December 31, 2023. The Company had deposits of $0.9 million and $0.7 million included in long-term assets as of December 31, 2023 and 2022, respectively, restricted from withdrawal and held by banks in the form of collateral for irrevocable standby letters of credit held as security for the leases
The Company determined its operating lease liabilities using payments through their current expiration dates and a weighted average discount rate of 8.0% based on the rate that the Company would have to pay to borrow, on a collateralized basis, an amount equal to the lease payments in a similar economic environment. Operating lease liabilities along with the associated ROU assets are disclosed in the accompanying consolidated balance sheets. After the adoption of ASC 842, Leases, the Company classified its deferred rent for tenant improvements with its operating lease ROU assets on the consolidated balance sheets.
Future minimum lease payments under non-cancelable operating leases as of December 31, 2023 are as follows (in thousands of dollars):
| Year Ending December 31, | Amounts |
|---|---|
| 2024 | $5,647 |
| 2025 | 5,729 |
| 2026 | 1,412 |
| 2027 | 593 |
| 2028 | 558 |
| Thereafter | 27 |
| Total future minimum lease payments | 13,966 |
| Less: amount representing interest | 1,336 |
| Present value of future lease payments | 12,630 |
| Less: short-term lease liabilities | 5,105 |
| Long-term lease liabilities | $7,525 |
The Company recognizes operating lease expense on a straight-line basis over the non-cancelable lease period. The following table summarizes operating lease expense and cash paid for amounts included in the measurement of lease liabilities (in thousands of dollars):
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Operating lease expense | $5,265 | $4,392 | $3,503 |
| Cash paid for amounts included in the measurement of lease liabilities | $5,365 | $4,527 | $3,650 |
The company has leased laboratory equipment under various financing leases. As of December 31, 2023 and 2022, the total ROU assets and total financing lease liabilities for these financing leases were $0.1 million and $0.1 million and $0.4 million and $0.4 million, respectively, and are included inproperty and equipment, net andother liabilities in the accompanying consolidated balance sheets.
The Company’s wholly-owned foreign subsidiary has entered into an arrangement under which it expects to sign a lease agreement for facilities which will be constructed in Marseille, France. The lease will commence upon completion of the construction of the office building at which time the Company will record a lease liability and a corresponding ROU asset. The initial term of the lease will betwelve years with annual rent of approximately $1.3 million, which is subject to change based on final construction and excludes common area maintenance costs.
Supplies Purchase Commitments
The Company had non-cancelable purchase commitments with suppliers to purchase a minimum quantity of supplies for approximately $19.4 million at December 31, 2023.
Contingencies
From time to time, the Company may be involved in legal proceedings arising in the ordinary course of business. The Company believes there is no litigation pending that could have, either individually or in the aggregate, a material impact on the Company's consolidated financial statements.
- Stockholders' Equity
Common Stock
The Company's Restated Certificate of Incorporation authorizes the Company to issue 125,000,000 shares of common stock with a par value of $0.001 per share. The holder of each share of common stock shall haveone vote for each share of stock. The common stockholders are also entitled to receive dividends whenever funds and assets are legally available and when declared by the board of directors, subject to the prior rights of holders of all series of convertible preferred stock outstanding. No dividends have been declared as of December 31, 2023.
As of December 31, 2023 and 2022, the Company had reserved shares of common stock for issuance as follows:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Stock options and restricted stock units issued and outstanding | 6,318,389 | 5,881,906 |
| Stock options and restricted stock units available for grant under stock option plans | 5,194,399 | 5,591,977 |
| Common stock available for the Employee Stock Purchase Plan | 1,189,513 | 1,335,353 |
| Total | 12,702,301 | 12,809,236 |
- Stock Incentive Plans
Stock Plans
On June 8, 2023, the Company’s stockholders approved the Company’s 2023 Equity Incentive Plan, or the 2023 Plan. The 2023 Plan, which became effective on June 8, 2023, serves as the successor to the Company’s 2013 Stock Incentive Plan, or the Prior Plan, and will terminate 10 years after the date approved by the Company’s board of directors. The 2023 Plan initially reserves for issuance 5,306,156 shares, which equals the number of reserved shares available for grant under the Prior Plan as of June 8, 2023. In addition, the number of (a) shares of common stock that are subject to awards granted under the Prior Plan that cease to be subject to such awards by forfeiture or otherwise after the effective date, (b) shares of common stock issued under the Prior Plan, including shares of common stock issued pursuant to the exercise of stock options, that are forfeited after the effective date, (c) shares of common stock issued under the Prior Plan that are repurchased by the Company at the original issue price after the effective date, (d) shares of common stock that are subject to awards granted under the Prior Plan that are settled in cash after the effective date, and (e) shares of common stock that are subject to awards under the Prior Plan that are used to pay the exercise price of an award or withheld to satisfy the tax withholding obligations related to an award after the effective date, is also reserved and eligible for issuance by the Company upon the exercise or settlement of awards to be granted under the 2023 Plan. The 2023 Plan permits the granting of stock options, restricted stock units, or RSUs, restricted stock awards, stock bonus awards, stock appreciation rights and performance awards to employees, consultants, and outside directors of the Company. Options granted may be either ISOs or NSOs. As of December 31, 2023,5,194,399 shares were available for future issuance under the 2023 Plan.
Stock options are governed by stock option agreements between the Company and recipients of stock options. Incentive stock options (ISOs), within the meaning of Section 422 of the Internal Revenue Code of 1986, as amended, and nonqualified stock options (NSOs), may be granted under the 2023 Plan at an exercise price of not less than 100% of the fair market value of the common stock on the date of grant, determined by the Compensation Committee of the board of directors. Options become exercisable and expire as determined by the Compensation Committee, provided that the term of ISOs may not exceedten years from the date of grant. Stock option agreements may provide for time-based and/or performance-based vesting as well as for accelerated exercisability in the event of an optionee's death, disability, or retirement or other events.
RSUs are governed by restricted stock unit agreements between the Company and recipients of RSUs. RSUs may be granted under the 2023 Plan and the number of stock units awarded are determined by the Compensation Committee of the board of directors. RSUs vest and expire as determined by the Compensation Committee. RSU agreements may provide for time-based and/or performance-based vesting as well as for accelerated vesting in the event of a RSU holder's death, disability, or retirement or other events.
Pursuant to the 2023 Plan, no non-employee director may receive awards under the 2023 Plan that, when combined with cash compensation received for service as a non-employee director, exceeds $750,000 in value in any calendar year ($1,500,000 in the calendar year in which such non-employee director first joins the board of directors). Awards under the 2023 Plan may be granted to non-employee directors, may be automatically made pursuant to a policy adopted by the Board of Directors, or made from time to time as determined in the discretion of the Board of Directors. In the event of a change in control transaction, the vesting of all awards granted to our non-employee directors will accelerate and such awards will become exercisable (as applicable) in full upon the consummation of such event at such times and on such conditions as the Compensation Committee determines.
The following table summarizes activity under the Company's stock incentive plans (aggregate intrinsic value in thousands):
| Stock OptionsOutstanding and Unvested Restricted Stock Units | WeightedAverageExercise Price of Stock Options | Weighted AverageRemainingContractual Life of Stock Options(Years) | AggregateIntrinsicValue of Stock Options | |
|---|---|---|---|---|
| Balance—December 31, 2022 | 5,881,906 | $21.10 | 6.30 | $23,450 |
| Granted - stock options | 660,592 | 23.60 | ||
| Granted - restricted stock units | 1,767,312 | |||
| Canceled | (570,203) | 8.34 | ||
| Exercised | (613,892) | 10.47 | ||
| Restricted stock units vested | (807,326) | |||
| Balance—December 31, 2023 | 6,318,389 | $22.95 | 6.58 | $24,466 |
| Options vested and exercisable—December 31, 2023 | 2,297,596 | $20.62 | 5.38 | $20,812 |
| Options vested and expected to vest—December 31, 2023 | 3,437,508 | $22.80 | 6.46 | $23,860 |
The aggregate intrinsic value was calculated as the difference between the exercise price of the options to purchase common stock and the fair market value of the Company's common stock, which was $27.51 and $23.73 per share as of December 31, 2023 and 2022, respectively.
The weighted average fair value of options to purchase common stock granted was $14.90, $14.61 and $23.45 for the years ended December 31, 2023, 2022 and 2021, respectively.
The aggregate estimated grant date fair value of employee options to purchase common stock vested during the years ended December 31, 2023, 2022 and 2021 was $8.1 million, $6.8 million and $7.8 million, respectively.
The intrinsic value of stock options exercised was $9.0 million, $6.3 million and $24.0 million for the years ended December 31, 2023, 2022 and 2021, respectively.
The weighted average fair value of RSUs granted was $23.92 and $24.37 for the years ended December 31, 2023, and 2022, respectively. The intrinsic value of RSUs vested was $20.9 million and $9.6 million for the years ended December 31, 2023 and 2022, respectively.
Included in RSUs granted for 2023, 2022 and 2021 are PSUs with a grant date fair value for remaining participants of $5.0 million, $2.0 million and $1.2 million, respectively, or the 2023 PSUs, 2022 PSUs and 2021 PSUs. These PSUs vest based on the achievement of certain performance conditions, subject to the employees’ continued service with the Company.
The service period for the 2021 PSUs began in 2022 and ended in February 2024. As of December 31, 2023, the Company assessed the probability of the achievement of the performance conditions related to the 2021 PSUs was less than likely, andno expense was recognized.
The service period for the 2022 PSUs began in 2023 ends in February 2025. The 2022 PSUs vest intwo tranches, one-third of the award in 2024 and two-thirds of the award in 2025. The awards may vest in a range of 75% to 125% of the target number of shares based on the level of achievement of the performance conditions. As of December 31, 2023, the Company assessed the probability of the achievement of the performance conditions related to the first tranche of the 2022 PSUs was likely, and recorded $0.7 million of expense in 2023. Any additional expense related to the 2022 PSUs will continue through 2024 based on the Company's assessment of the probability of the achievement of the 2022 PSUs performance conditions.
The service period for the 2023 PSUs begins in 2024 and ends in February 2026. The 2023 PSUs vest intwo tranches,40% of the award in 2025 and 60% of the award in 2026. The awards may vest in a range of 75% to 150% of the target number of shares based on the level of achievement of the performance conditions. Any expense related to the 2023 PSUs will begin in 2024 and will be based on the Company's assessment of the probability of the achievement of the 2023 PSUs performance conditions.
Employee Stock Purchase Plan
The Company's stockholders approved the Company's ESPP in May 2015 and approved an amendment and restatement of the Company’s ESPP in June 2020. The ESPP provides eligible employees with an opportunity to purchase common stock from the Company and to pay for their purchases through payroll deductions. The ESPP will be implemented through a series of offerings of purchase rights to eligible employees. Under the ESPP, the Compensation Committee of the Company's board of directors may specify offerings with a duration of not more than 12 months and may specify shorter purchase periods within each offering. During each purchase period, payroll deductions will accumulate, without interest. On the last day of the purchase period, accumulated payroll deductions will be used to purchase common stock for employees participating in the offering.
Pursuant to the ESPP, the purchase price will be 85% of the fair market value per share of the Company's common stock on either the offering date or on the purchase date, whichever is less.
The Company's board of directors has determined that the offering periods will begin each calendar year on August 1 and February 1, will be twelve (12) months in duration and include two (2) purchase periods, each purchase period lasting six (6) months. The Company's board of directors has determined that the purchase price will be 85% of the fair market value per share of the Company's common stock on either the offering date, which is the first trading day of the offering period, or the purchase date, which is the last trading day of the purchase period, whichever is less. The length of the offering period, the purchase period and the purchase price may not be changed without the approval of the independent members of the Compensation Committee of the Company's board of directors. If the fair market value of a share of the Company's common stock on any purchase date within a particular offering period is less than the fair market value on the start date of that offering period, then the offering period will automatically terminate and the employees in that offering period will automatically be transferred and enrolled in a new offering period which will begin on the next day following such purchase date.
No employee is permitted to accrue, under the ESPP, a right to purchase stock of the Company having a value in excess of $25,000 of the fair market value of such stock (determined at the time the right is granted) for each calendar year. As of December 31, 2023,1,189,513 shares of common stock were reserved for issuance under the ESPP.
The following table summarizes stock-based compensation expense related to stock options, RSUs and the ESPP for the years ended December 31, 2023, 2022 and 2021, and are included in the consolidated statements of operations as follows (in thousands of dollars):
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Cost of revenue | $1,779 | $1,053 | $640 |
| Research and development | 5,277 | 6,004 | 4,636 |
| Selling and marketing | 9,588 | 5,936 | 4,390 |
| General and administrative | 16,497 | 13,741 | 12,853 |
| Total stock-based compensation expense | $33,141 | $26,734 | $22,519 |
As of December 31, 2023, the Company had $61.7 million of unrecognized compensation expense related to unvested stock options and RSUs, which is expected to be recognized over an estimated weighted-average period of 2.5 years.
The estimated grant-date fair value of stock options was calculated using the Black-Scholes option-pricing model, based on the following assumptions.
Expected Term: The expected term represents the period that the options granted are expected to be outstanding, and is determined using the Company's historical data.
Expected Volatility: The Company uses the historical volatility of its common stock.
Risk-Free Interest Rate: The Company based the risk-free interest rate over the expected term of the options based on the constant maturity rate of U.S. Treasury securities with similar maturities as of the date of the grant.
Expected Dividend Yield: The Company has not paid and does not anticipate paying any dividends in the near future. Therefore, the expected dividend yield waszero.
The estimated grant-date fair value of employee stock options using the Black-Scholes option-pricing model was based on the following assumptions:
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Weighted-average volatility | 68.82 - 69.78% | 62.64 - 67.66% | 56.83 - 60.48% |
| Weighted-average expected term (years) | 5.44 - 5.66 | 5.26 - 5.27 | 5.05 - 5.25 |
| Risk-free interest rate | 3.51 - 4.72% | 1.72 - 4.21% | 0.40 - 1.21% |
| Expected dividend yield | — | — | — |
The estimated grant date fair value of the ESPP shares was calculated using the Black-Scholes option-pricing model, based on the following assumptions:
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Weighted-average volatility | 54.86 - 83.69% | 75.04 - 88.59% | 62.03 - 80.70% |
| Weighted-average expected term (years) | 0.50 - 1.00 | 0.50 - 1.00 | 0.50 - 1.00 |
| Risk-free interest rate | 4.61 - 5.46% | 0.47 - 2.96% | 0.06 - 0.08% |
| Expected dividend yield | — | — | — |
- Income Taxes
The Company generated a pre-tax loss of $76.6 million, $36.4 million and $81.6 million in the United States for the years ended December 31, 2023, 2022 and 2021, respectively. Starting in 2020, the Company began generating pre-tax loss outside the United States. Pre-tax loss has been recorded in the following jurisdictions for the years ended December 31, 2023, 2022 and 2021 (in thousands of dollars):
| Year Ended December, 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| United States | $(15,853) | $(16,816) | $(68,707) |
| Foreign | (60,759) | (19,611) | (12,942) |
| Total | $(76,612) | $(36,427) | $(81,649) |
The Company recorded an income tax benefit in 2023 of $2.2 million primarily due to reductions in deferred tax liabilities from acquired entities partially offset by foreign and state income taxes. The Company recorded an income tax provision in 2022 of $0.1 million primarily due to foreign and state income taxes offset partially by reductions in deferred tax liabilities from acquired entities. The Company recorded an income tax benefit in 2021 of $6.1 million primarily due to the release of certain valuation allowances on the Company's deferred tax assets upon recording of the deferred tax liabilities upon acquisition of Decipher Biosciences and a provision benefit recorded on the 2021 year loss of HalioDx French entity. The components of the (benefit) provision for income taxes are as follows for the years ended December 31, 2023, 2022 and 2021 (in thousands of dollars):
| Year Ended December, 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Current: | |||
| Federal | $— | $— | $— |
| State | 1,520 | 426 | 63 |
| Foreign | 193 | 134 | 54 |
| Total current | 1,713 | 560 | 117 |
| Deferred: | |||
| Federal | — | — | (3,526) |
| State | (90) | 118 | (508) |
| Foreign | (3,831) | (545) | (2,169) |
| Total deferred | (3,921) | (427) | (6,203) |
| Total income tax provision (benefit) | $(2,208) | $133 | $(6,086) |
The Company follows FASB ASC No. 740, Income Taxes for the Computation and Presentation of its Tax Provision. The following table presents a reconciliation of the income tax expense computed at the statutory federal rate and the Company's income tax expense for the periods presented (in thousands of dollars):
| Year Ended December, 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| U.S. federal taxes at statutory rate | $(16,088) | $(7,573) | $(17,146) |
| State tax (net of federal benefit) | (491) | 720 | (1,609) |
| Foreign rate differential | 9,049 | 3,726 | 674 |
| Non-deductible officers' compensation | 639 | 729 | 3,055 |
| Transaction costs | 477 | — | 2,255 |
| Permanent differences | 419 | 79 | 59 |
| Stock based compensation - excess benefit | 739 | 1,874 | (5,687) |
| Tax credits | (1,551) | (936) | (714) |
| Other | (176) | — | — |
| Change in valuation allowance | 4,775 | 1,514 | 13,027 |
| Total | $(2,208) | $133 | $(6,086) |
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company's deferred tax assets and liabilities are as follows (in thousands of dollars):
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Deferred tax assets: | |||
| Net operating loss carryforwards | $110,975 | $126,225 | $133,492 |
| Research and development credits | 10,728 | 8,907 | 7,926 |
| Section 174 capitalization | 17,388 | 6,719 | — |
| Stock-based compensation | 4,503 | 4,080 | 3,760 |
| NanoString intangibles and goodwill | 8,778 | 1,447 | 1,244 |
| Operating lease liability | 3,335 | 3,622 | 4,327 |
| Accruals and other | 7,128 | 6,596 | 7,099 |
| Gross deferred tax assets | 162,835 | 157,596 | 157,848 |
| Valuation allowance | (139,920) | (125,378) | (120,586) |
| Net deferred tax assets | 22,915 | 32,218 | 37,262 |
| Deferred tax liabilities: | |||
| Property and equipment | (83) | (235) | (219) |
| Other acquired intangibles | (17,358) | (29,457) | (34,823) |
| In-process research and development | (3,461) | (3,702) | (3,892) |
| ROU assets | (2,747) | (3,355) | (3,920) |
| Gross deferred tax liabilities | (23,649) | (36,749) | (42,854) |
| Net deferred tax liabilities | (23,649) | (36,749) | (42,854) |
| Net deferred taxes | $(734) | $(4,531) | $(5,592) |
The Company records net deferred tax assets to the extent it is more likely than not that the assets will be realized. In making such determination, the Company considered all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax planning strategies and recent financial operations. The Company has established a valuation allowance against its net deferred tax assets due to the uncertainty surrounding realization of such assets. The valuation allowance increased $14.5 million, $4.8 million and $41.9 million during the years ended December 31, 2023, 2022 and 2021, respectively.
As of December 31, 2023, the Company had net operating loss carryforwards of approximately $320.7 million, $77.4 million and $113.6 million available to reduce future taxable income, if any, for federal, California and other state income tax purposes, respectively. The U.S. federal net operating loss carryforwards will begin to expire in 2035 while for state purposes, the net operating losses begin to expire in 2024.
As of December 31, 2023, the Company had foreign net operating loss carryforwards of approximately $71.0 million and $53.1 million available to reduce future taxable income, if any, for Canadian and French income tax purposes, respectively. The Canada net operating loss carryforwards will begin to expire in 2034, while for French purposes, the net operating losses will carryforward indefinitely.
As of December 31, 2023, the Company had net research and development credit carryforwards of approximately $8.3 million and $7.1 million available to reduce future taxable income, if any, for federal and state income tax purposes, respectively. The federal credit carryforwards begin to expire in 2028. California credits have no expiration date. Other state credit carryforwards begin to expire in 2024.
The Company also had scientific net research and development credit carryforwards of approximately $1.8 million available to reduce future taxable income, if any, for Canadian income tax purposes. The credit carryforwards begin to expire in 2025.
The Internal Revenue Code of 1986, as amended, imposes restrictions on the utilization of net operating losses and tax credits in the event of an "ownership change" of a corporation. Accordingly, a company's ability to use net operating losses and tax credits may be limited as prescribed under Internal Revenue Code Section 382 and 383, or IRC Section 382. Events which may cause limitations in the amount of the net operating losses or tax credits that the Company may use in any one year include, but are not limited to, a cumulative ownership change of more than 50% over a three-year period. Utilization of the federal and state net operating losses may be subject to substantial annual limitation due to the ownership change limitations provided by the IRC Section 382 rules and similar state provisions. In the event the Company has any changes in ownership, net operating losses and research and development credit carryovers could be limited and may expire unutilized.
Uncertain Tax Positions
As of December 31, 2023, the Company had unrecognized tax benefits of $5.7 million, none of which currently would affect the Company's effective tax rate if recognized due to the Company's deferred tax assets being fully offset by a valuation allowance. The Company does not anticipate that the amount of unrecognized tax benefits relating to tax positions existing at December 31, 2023 will significantly increase or decrease within the next 12 months.
A reconciliation of the beginning and ending amount of unrecognized tax benefits is as follows (in thousands of dollars):
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Unrecognized tax benefits, beginning of period | $4,888 | $4,452 | $3,563 |
| Gross increases—tax position in prior period | 37 | — | 515 |
| Gross decreases—tax position in prior period | (11) | (31) | — |
| Gross increases—current period tax position | 773 | 467 | 374 |
| Lapse of statute of limitations | — | — | — |
| Unrecognized tax benefits, end of period | $5,687 | $4,888 | $4,452 |
It is the Company's policy to include penalties and interest expense related to income taxes as a component of other income (expense), net, and interest expense, respectively, as necessary. There wasno interest expense or penalties related to unrecognized tax benefits recorded through December 31, 2023.
The Company's major tax jurisdictions are the United States, France, Canada, and California. All of the Company's tax years will remain open for examination by the Federal and state tax authorities forthree andfour years, respectively, from the date of utilization of the net operating loss or research and development credit. The Company does not have any tax audits pending in the United States. There is an audit of Veracyte SAS ongoing in France.
The Inflation Reduction Act of 2022 was signed into law August 16, 2022, and includes significant legislation addressing taxes, inflation, climate change and renewable energy incentives, and healthcare. Key tax provisions include a 15% corporate minimum tax, clean energy incentives, and a 1% excise tax on stock buybacks. The provisions of such legislation did not have any impact on the effective tax rate of the Company during 2023, and the Company will continue to evaluate the tax effects should any provisions become applicable to the Company.
Change to Internal Revenue Code Section 174 under the 2017 Tax Cuts and Jobs Act went into effect during 2022. The revised code no longer permits a deduction for research and development expenditures in the tax year that such costs incurred. Instead, such costs must be capitalized and amortized over five or 15 years for U.S. and foreign costs, respectively. The Company capitalized such costs in its 2022 and 2023 income tax provisions, resulting in an increase in deferred tax assets.
- Employee Benefit Plans
401(k) plan
The Company sponsors a 401(k) defined contribution plan covering all employees. Under the plan, participants are entitled to make pre-tax contributions up to the annual maximums established by the Internal Revenue Service. The Company, at its discretion, may make matching contributions to the 401(k) plan. Employer contributions to the plan were $1.5 million, $1.4 million and $1.3 million for the years ended December 31, 2023, 2022, and 2021, respectively.
Pension plan
The Company also maintains a defined benefit plan for certain non-U.S. employees of its Veracyte SAS subsidiary. The pension liability is included in other long-term liabilities on the Company's consolidated balance sheets and totaled $0.8 million and $0.7 million as of December 31, 2023 and 2022, respectively.
- Components of Other Income, net
Other income, net consists of the following (in thousands of dollars):
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| French research tax credits | $571 | $2,423 | $1,535 |
| Interest and dividend income | 7,344 | 1,972 | 135 |
| Interest expense | (15) | (198) | (241) |
| Gain (loss) on currency revaluation | 723 | 197 | (1,081) |
| Other | 560 | 260 | (94) |
| Total | $9,183 | $4,654 | $254 |
- Subsequent Event
On February 5, 2024 the Company completed its previously announced acquisition of 100% of the outstanding equity of C2i for a purchase price of $70.0 million to C2i securityholders, subject to customary purchase price adjustments. C2i was a privately-held company providing MRD detection. The consideration to acquire C2i comprised $8.0 million deposited into escrow to secure certain indemnification obligations of the C2i securityholders, $0.2 million deposited with the securityholders’ agent for payment or reimbursement of certain expenses potentially to be incurred by the securityholders’ agent in connection with the acquisition and the as-adjusted remainder paid to the C2i securityholders in an aggregate amount of up to 2,698,349 shares of the Company's common stock. In addition, the Company may pay up to $25.0 million to C2i securityholders based on the achievement of future performance milestones over the nexttwo years, or the Milestone Payments. Subject to certain limitations, the Milestone Payments shall be payable in cash or shares of the Company's common stock at the Company's election.
In accordance with ASC Topic 805, Business Combinations, or Topic 805, the C2i acquisition will be accounted for as a business combination. Due to the close proximity of the acquisition date and the filing of the Company`s Annual Report on Form 10-K for the year ended December 31, 2023, the Company is unable to disclose the information required by Topic 805. The results of operations of C2i will be consolidated with those of the Company from the acquisition date, beginning in the first quarter of 2024.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.