NovoCure Ltd
For the period ended Dec 31, 2023. Filed Feb 22, 2024.
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FY2023 · Filed Feb 22, 2024
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Notes to Consolidated Financial Statements
Note 1: Organization
NovoCure Limited (including its consolidated subsidiaries, the "Company") was incorporated in the Bailiwick of Jersey and is principally engaged in the development, manufacture and commercialization of Tumor Treating Fields ("TTFields") devices, including Optune Gio and Optune Lua (collectively, its "Products"), for the treatment of solid tumor cancers. The Company currently markets its Products in the United States ("U.S."), Germany, Japan and certain other countries. The Company also has a License and Collaboration Agreement (the "Zai Agreement") with Zai Lab (Shanghai) Co., Ltd. ("Zai") to market the Company's Products in China, Hong Kong, Macau and Taiwan ("Greater China"). See Note 12.
During the year ended December 31, 2019, the Company implemented changes to its corporate entity operating structure, including transferring certain intellectual property to its Swiss subsidiary, primarily to align corporate entities with the Company’s evolving operations and business model. As of January 1, 2022, the effective place of daily management and control of the Company moved to Switzerland and the Company has become a Swiss tax resident.
In November 2023, the Company announced a series of actions to strengthen and optimize its business operations to support near-term growth drivers and long-term value creation. The plan included a reduction in headcount of approximately 200 employees or 13% of the Company's then current workforce. The Company expects to incur total one-time costs related to the workforce reduction of approximately $7,000 across the fourth quarter of 2023 and the first quarter of 2024. Restructuring costs (including severance pay, garden leave payments, etc.) in the amount of $6,231 were included in the financial statements for the year ended December 31, 2023, of which $262 are attributable to Cost of Goods Sold, $2,070 to Research and Development, $2,404 to Sales and Marketing and $1,495 to General and Administrative expenses. Of these amounts, $2,753 have been paid in 2023. The $6,231 is offset by forfeited equity-based compensation expense and accrual reversals in the amount of $9,313 and $3,041, respectively, which relate to the terminated employees' exits from the Company’s equity and cash incentive plans.
Note 2: Basis of presentation and significant accounting policies
The consolidated financial statements are prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”).
a. Use of estimates:
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. The Company evaluates on an ongoing basis its assumptions, including those related to contingencies, deferred taxes, tax liabilities, useful-life of field equipment, right-of-use assets and lease liabilities, convertible notes, pension liabilities, revenue, accrued expenses and share-based compensation costs. The Company’s management believes that the estimates, judgment and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities at the dates of the consolidated financial statements, and the reported amounts of net revenue and expenses during the reporting period. Actual results could differ from those estimates.
b. Financial statements in U.S. dollars:
The accompanying financial statements have been prepared in U.S. dollars in thousands, except for share and per-share data.
The Company finances its operations in U.S. dollars and a substantial portion of its costs and revenues from its primary markets is incurred in U.S. dollars. As such, the Company’s management believes that the U.S. dollar is the currency of the primary economic environment in which NovoCure Limited and certain subsidiaries operate. The Company’s reporting currency is U.S. dollars.
Transactions and balances denominated in U.S. dollars are presented at their original amounts. Monetary accounts maintained in currencies other than the U.S. dollar are re-measured into dollars in accordance with Accounting Standards Codification (ASC) No. 830-10, "Foreign Currency Matters." All transaction gains and losses of the re- measurement of monetary balance sheet items are reflected in the consolidated statements of operations as financial income or expenses, as applicable.
For a subsidiary whose functional currency has been determined to be its local currency, assets and liabilities are translated at year-end exchange rates and statement of operations items are translated at average exchange rates prevailing during the year. Such translation adjustments are recorded as a separate component of accumulated other comprehensive income (loss) in shareholders' equity.
c. Principles of consolidation:
The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. Intercompany transactions and balances, including unrealized profits from intercompany sales, have been eliminated upon consolidation.
d. Cash equivalents:
Cash equivalents are short-term, highly liquid investments that are readily convertible into cash with a maturity of three months or less at the date acquired.
e. Short-term investments:
The Company accounts for investments in debt securities in accordance with ASC 320, "Investments—Debt and Equity Securities." Management determines the appropriate classification of its investments in marketable debt securities at the time of purchase and reevaluates such determinations at each balance sheet date.
Available-for-sale debt securities are carried at fair value, with the unrealized gains and losses, net of tax, reported in accumulated other comprehensive income (loss) in shareholders’ equity. Realized gains and losses on sale of investments are included in financial (expenses) income, net and are derived using the specific identification method for determining the cost of securities sold.
The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization together with interest on securities is included in financial (expenses) income, net.
Each reporting period, the Company evaluates whether declines in fair value below amortized cost are due to expected credit losses, as well as the Company’s ability and intent to hold the investment until a forecasted recovery occurs. Allowance for credit losses on available-for-sale debt securities are recognized in the Company’s consolidated statements of operation, and any remaining unrealized losses, net of taxes, are included in accumulated other comprehensive income (loss) in stockholders’ equity.
Held-to-maturity debt securities are stated at amortized cost of which is adjusted for amortization of premiums and accretion of discounts to maturity and any credit losses. Such amortization, interest or credit losses are included in the consolidated statement of operations as financial income or expenses, as appropriate.
As of December 31, 2023 and 2022, all securities are classified as held-to-maturity since the Company has the intent and ability to hold the securities to maturity and, accordingly, debt securities are stated at amortized cost.
For the years ended December 31, 2023, 2022 and 2021, no credit losses have been identified.
f. Restricted cash
The Company has restricted cash used as security for the use of Company credit cards and cash management, presented in short-term assets. Additionally, the Company has pledged bank deposits to cover bank guarantees related to facility rental agreements, fleet lease agreements and customs payments presented in other long-term assets (see Note 12).
g. Trade receivables:
The Company’s trade receivables balance contains billed and unbilled commercial activities. The Company records an allowance for credit losses, if identified. The Company periodically reviews its customers’ credit risk and payment history. To date, the Company has not experienced any material credit losses related to counter-party risk.
h. Inventories:
Inventories are stated at the lower of cost or net realizable value. Cost is determined using the weighted average method. The Company regularly evaluates its ability to realize the value of inventory. If the inventories are deemed damaged, if actual demand for the Company’s devices deteriorates, or if market conditions are less favorable than those projected, inventory write-offs may be required.
Inventory write-offs of $681, $917 and $1,045, respectively, were recorded for the years ended December 31, 2023, 2022 and 2021.
i. Property and equipment:
Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets at the following rates:
| % | |
|---|---|
| Computers and laboratory equipment | 15 - 33 |
| Office furniture | 6 - 33 |
| Production equipment | 20 |
| Leasehold improvements | Over the shorter of the term of the lease or its useful life |
Land and assets held within construction in progress are not depreciated. Construction in progress is related to the construction or development of property and equipment that is not yet ready for its intended use.
j. Field equipment:
Field equipment is stated at cost, net of accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful life of the field equipment, which was determined to be 18 to 60 months. Field equipment is equipment being utilized under service agreements, and accounted for in accordance with ASC 842 on a monthly basis as an operating lease (see Note 2(x)). The Company records a write-off provision for any excess, lost or damaged equipment when warranted based on an assessment of the equipment. Write-offs for equipment are included in cost of revenues (see Note 7).
k. Impairment of long-lived assets:
The Company’s long-lived assets are reviewed for impairment in accordance with ASC 360-10, "Property, Plant and Equipment," whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. Recoverability of an asset to be held and used is measured by a comparison of the carrying amount of an asset to the future undiscounted cash flows expected to be generated by the asset. If such asset is considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the asset exceeds its fair value. During the three years ended December 31, 2023, no impairment losses have been identified.
l. Other long-term assets:
Restricted deposits, long-term lease deposits associated with office rent and vehicles under operating leases, prepaid and vendors down payments are presented in other long-term assets.
m. Revenue recognition:
Our Products are comprised of two main components: (1) an electric field generator and (2) arrays and related accessories. We retain title to the electric field generator, and the patient is provided replacement arrays and technical support for the device during the term of treatment. The electric field generator and arrays are always supplied and function together and are not sold on a standalone basis.
The Company uses the portfolio approach to apply the standard to portfolios of contracts with similar characteristics.
To recognize revenue under ASC 606, the Company applies the following five steps:
Identify the contract with a patient. A contract with a patient exists when (i) the Company enters into an enforceable contract with a patient that defines each party’s rights regarding delivery of and payment for a Product, (ii) the contract has commercial substance and (iii) the Company determines that collection of substantially all consideration for such Product is probable based on the payer’s intent and ability to pay the promised consideration. The evidence of a contract generally consists of a prescription, a patient service agreement and the verification of the assigned payer for the contract and intention to collect.
Identify the performance obligations in the contract. Our contracts include the lease of the device, the supply obligation of disposable arrays and technical support for the term of treatment. To the extent a contract includes multiple promised products and/or services, the Company must apply judgment to determine whether those products and/or services are capable of being distinct in the context of the contract. If these criteria are not met the promised products and/or services are accounted for as a combined performance obligation. In the Company’s case, the device, support, and disposables are provided as one inseparable package of monthly treatment for a single monthly fee. For more information, see Note 2(x).
Determine the transaction price. The transaction price is determined based on the consideration to which the Company will be entitled in exchange for providing a Product to the patient. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price utilizing either the expected value method or the most likely amount method depending on the nature of the variable consideration. In determining the transaction price, the Company includes variable consideration if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. The Company reassesses variable consideration at each reporting period and, if necessary, these estimates are adjusted to reflect the anticipated amounts to be collected when those facts and circumstances become known.
The Company has agreements with many payers that define explicit discounts off the gross transaction price. In addition to the explicit discounts negotiated with each payer, the Company expects to receive, in aggregate for a given portfolio, less than the gross revenue net of explicit discounts. ASC 606 requires that the Company recognize this variable consideration as an implicit discount at the time the goods or services are provided. The implicit discount includes both an estimate of claims that will pay at an amount less than billed and an estimate of claims that will not pay within a given time horizon. The estimation of implicit discount adjustments to the transaction price are based on historical price concession experience within payors and expected future concession. If actual amounts of consideration ultimately received differ from the Company’s estimates, the Company adjusts these estimates, which would affect net revenue in the period such adjustments become known.
Allocate the transaction price to performance obligations in the contract. If a contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. As discussed above, there is a combined performance obligation under the Company’s contracts and, therefore, the monthly transaction price determined for the performance obligation will be recognized over time ratably over the monthly term of the treatment.
Recognize revenue when or as the Company satisfies a performance obligation. The Company satisfies performance obligations over time. Revenue is recognized at the time the related performance obligation is satisfied by transferring a promised service to a patient. The patient consumes the benefits of treatment on a daily basis over the monthly term. As this criterion is met, the revenues will be recognized over the monthly term. For more information, see Note 2(x).
The Company elected the short-term contract exemption for the remaining transaction price disclosures, as the Company's contracts have an original expected duration of less than one year.
Revenues are presented net of indirect taxes.
The Company has elected to apply the practical expedient for financing component for transactions in which the difference between the payment date and the revenue recognition timing is up to 12 months. Payment terms between the Company and its payors are typically up to twelve months, and vary by the type of payer, country of sale and the products or services offered.
Net revenues in the years ended December 31, 2023, 2022 and 2021 also include amounts recognized pursuant to the Zai Agreement. For additional information, see Note 13.
n. Charitable care:
The Company provides treatment at no charge to patients who meet certain criteria under its charitable care policy. Because the Company does not pursue collection of amounts determined to qualify as charity, they are not reported as revenue. The Company's costs of care provided under charitable care were $2,692, $3,009 and $4,204 for the years ended December 31, 2023, 2022 and 2021, respectively. These amounts were determined by applying charitable care as a percentage of gross billings to total cost of goods sold.
o. Shipping and handling costs:
The Company does not separately bill its customers for shipping and handling costs associated with shipping Products to its customers. These direct shipping and handling costs of $2,871, $3,211 and $2,958 for the years ended December 31, 2023, 2022 and 2021, respectively, are included in Sales and Marketing costs.
p. Accounting for share-based compensation:
The Company accounts for share-based compensation in accordance with ASC 718, "Compensation—Stock Compensation." ASC 718 requires companies to estimate the fair value of share-based compensation awards on the date of grant using an option-pricing model. The value of the award is recognized as an expense over the requisite service periods in the Company’s consolidated statements of operations. The Company's policy is to account for forfeitures as they occur.
The Company recognizes compensation costs for the value of awards granted using the accelerated method over the requisite service period of the award, which for restricted share units istwo orthree years and for option awards, which istwo orfour years.
The Company recognizes compensation costs for the value of performance stock units ("PSU") over the performance period when the vesting conditions become probable in accordance with ASC 718.
The Company applies the Black-Scholes model as it believes it is the most appropriate fair value method for all equity awards and for the Employee Share Purchase Plan (the "ESPP"). For market condition awards, the Company also applies the Monte-Carlo simulation model. The Black-Scholes model requires a number of assumptions, of which the most significant are the share price, expected volatility and the expected award term.
Beginning with the first quarter of 2022, the computation of expected volatility is based on the historical volatility the Company's shares, beginning with the first quarter of 2021 and prior to the first quarter of 2022, the computation of expected volatility is based on a combination of actual historical share price volatility of comparable publicly-traded companies and the historical volatility the Company's shares. Prior to the first quarter of 2021, due to the lack of sufficient historical information for the Company, the computation was based on actual historical volatility of comparable publicly-traded companies. Beginning with the first quarter of 2021, the expected term of options granted is calculated using the Company's historical and future exercise behavior. Prior to the first quarter of 2021, it was calculated using the average between the vesting period and the contractual term to the expected term of the options in effect at the time of grant. The Company has historically not paid dividends and has no foreseeable plans to pay dividends and, therefore, uses an expected dividend yield ofzero in the option pricing model. The risk-free interest rate is based on the yield of U.S. treasury bonds with equivalent terms.
q. Fair value of financial instruments:
The carrying amounts of cash and cash equivalents, short-term investments, restricted cash, receivables and prepaid expenses, trade receivables, trade payables and other accounts payable and accrued expenses approximate their fair value due to the short-term maturity of such instruments.
The Company accounts for certain assets and liabilities at fair value under ASC 820, "Fair Value Measurements and Disclosures." Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability.
The hierarchy below lists three levels of fair value based on the extent to which inputs used in measuring fair value are observable in the market. The Company categorizes each of its fair value measurements in one of these three levels based on the lowest level input that is significant to the fair value measurement in its entirety.
The three levels of inputs that may be used to measure fair value are as follows:
Level 1 - Observable inputs that reflect quoted prices (unadjusted) for identical assets or liabilities in active markets;
Level 2 - Includes other inputs that are directly or indirectly observable in the marketplace, other than quoted prices included in Level 1, such as quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets with insufficient volume or infrequent transactions, or other inputs that are observable (model-derived valuations in which significant inputs are observable), or can be derived principally from or corroborated by observable market data; and
Level 3 - Unobservable inputs which are supported by little or no market activity.
The availability of observable inputs can vary from instrument to instrument and is affected by a wide variety of factors, including, for example, the type of instrument, the liquidity of markets and other characteristics particular to the transaction. To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment and the instrument is categorized as Level 3.
r. Basic and diluted net loss per share:
Basic net income (loss) per share is computed based on the weighted average number of ordinary shares outstanding during each period. Diluted net income per share is computed based on the weighted average number of ordinary shares outstanding during the period, plus potential dilutive shares considered outstanding during the period, in accordance with ASC 260-10, as determined under the treasury stock method.
s. Income taxes:
The Company accounts for income taxes in accordance with ASC 740-10, "Income Taxes." ASC 740-10 prescribes the use of the liability method whereby deferred tax asset and liability account balances are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company provides a valuation allowance, to reduce deferred tax assets to their estimated realizable value, if needed.
The Company established reserves for uncertain tax positions based on the evaluation of whether or not the Company’s uncertain tax position is "more likely than not" to be sustained upon examination. The Company records interest and penalties pertaining to its uncertain tax positions in the financial statements as income tax expense.
t. Concentration of risks:
Our cash, cash equivalents, short-term investments and trade receivables are potentially subject to a concentration of risk. Cash, cash equivalents and short-term investments are invested at top tier financial institutions globally. As such, these investments may be in excess of insured limitations or not insured in certain jurisdictions. Generally, these investments may be redeemed upon demand and therefore, bear minimal risk.
Our trade receivables are due from numerous governments and federal and state agencies that are paid from their respective budgets, and from hundreds of health insurance companies. The Company does not believe that there are significant default risks associated with these governments, agencies and health insurance companies based upon the Company's historical experience with them.
The Company has no off-balance sheet concentrations of credit risk such as foreign exchange contracts, option contracts or other foreign hedging arrangements.
u. Retirement, pension and severance plans:
The Company has a 401(k) retirement savings plan for its U.S. employees. Each eligible employee may elect to contribute a portion of the employee’s compensation to the plan. Company contributions to the plan are at the sole discretion of the Company's Board of Directors. Currently, the Company provides a matching contribution of 50% of the employee's contributions, up to a maximum ofthree percent (3%) of the employee's annual salary. The Company began making matching contributions as of January 1, 2019. For the years ended December 31, 2023, 2022 and 2021, the Company had made matching contributions in the amount of $2,375 and $2,083 and $1,967, respectively, pursuant to the plan.
The Company sponsors a defined benefit plan (the "Swiss Plan") for all its employees in Switzerland for retirement benefits, as well as benefits on death or long-term disability, whereby the employee and the Company contribute a portion of the employee's compensation to the plan. The Swiss Plan is part of a collective pension foundation “AXA Foundation for Occupational Benefits”. This is a semi-autonomous pension foundation, meaning that the underlying investment risk and the longevity are born by the pension foundation itself. Disability and death risks are reinsured with AXA insurance. Notwithstanding, the Company and its employees bear the risk of having to pay recovery contributions in a financial distress situation. The Company accounts for this risk in accordance with ASC 715, "Compensation – Retirement Benefits" (see Note 9). The pension expense for the years ended December 31, 2023, 2022 and 2021 was $2,672, $2,104 and $1,494, respectively.
Israeli law generally requires payment of severance pay upon dismissal of an employee or upon termination of employment in certain other circumstances. The Company contributes to employee pension plans to fund its severance liabilities. According to Section 14 of Israel Severance Pay Law, the Company makes deposits on behalf of its employees with respect to the Company’s severance liability and therefore no obligation is provided for in the financial statements. Severance pay liabilities with respect to employees who are not subject to Section 14, are provided for in the financial statements based upon the number of years of service and the latest monthly salary and the related deposits are recorded as an asset based on the cash surrender value. Contributions pursuant to these obligations for the years ended December 31, 2023, 2022 and 2021 amounted to $1,735, $1,594 and $1,466, respectively.
v. Contingent liabilities:
The Company accounts for its contingent liabilities in accordance with ASC 450, "Contingencies." A provision is recorded when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated.
With respect to legal matters, provisions are reviewed and adjusted to reflect the impact of negotiations, estimated settlements, legal rulings, advice of legal counsel and other information and events pertaining to a particular matter.
w. Other comprehensive income (loss):
The Company accounts for comprehensive income (loss) in accordance with ASC 220, "Comprehensive Income." ASC 220 establishes standards for the reporting and display of comprehensive income (loss) and its components. Comprehensive income (loss) generally represents all changes in shareholders' equity during the period except those resulting from investments by, or distributions to, shareholders. The accumulated other comprehensive income (loss), net of taxes, relates to a pension liability, unrealized gain (loss) from debt securities and foreign currency translation adjustments.
x. Leases:
- Lessee accounting:
The Company determines if an arrangement is a lease and the classification of that lease at inception based on: (1) whether the contract involves the use of a distinct identified asset, (2) whether the Company obtains the right to substantially all the economic benefits from the use of the asset throughout the period, and (3) whether the Company has a right to direct the use of the asset. The Company elected to not recognize a lease liability or right-of-use ("ROU") asset for leases with a term of twelve months or less. The Company also elected the practical expedient to not separate lease and non-lease components for its leases.
ROU assets represent the right to use an underlying asset for the lease term and lease liabilities represent the obligation to make minimum lease payments arising from the lease. ROU assets are initially measured at amounts, which represents the discounted present value of the lease payments over the lease, plus any initial direct costs incurred. The ROU assets are reviewed for impairment. The lease liability is initially measured at lease commencement date based on the discounted present value of minimum lease payments over the lease term. The implicit rate within the operating leases are generally not determinable; therefore, the Company uses the Incremental Borrowing Rate ("IBR") based on the information available at commencement date in determining the present value of lease payments. The Company’s IBR is estimated to approximate the interest rate on similar terms and payments and in economic environments where the leased asset is located.
Certain leases include options to extend or terminate the lease. An option to extend the lease is considered in connection with determining the ROU asset and lease liability when it is reasonably certain that the Company will exercise that option. An option to terminate is considered unless it is reasonably certain that the Company will not exercise the option.
- Lessor accounting - Operating leases:
ASC 842 provides lessors with an optional practical expedient, by class of underlying asset, not to separate non-lease components from the associated lease component and, instead, to account for those components as a single component if the non-lease components otherwise would be accounted for under the revenue guidance (ASC 606) and both of the following criteria are met:
a. The timing and pattern of transfer of the lease component and the non-lease component(s) are the same; and
b. The lease component would be classified as an operating lease if it were accounted for separately.
The Company's product supply agreements include the right to use the device (lease component), the supply obligation of disposable arrays and technical support for the term of treatment (non-lease component).
If the lease component is the predominant component, the Company accounts for all revenues under such lease as a single component in accordance with the lease accounting standard. Conversely, if the non-lease component is the predominant component, all revenues under such lease are accounted for in accordance with the revenue recognition accounting standard. The Company's operating leases qualify for the single component accounting, and the non-lease component in each of the Company's leases is predominant. Therefore, The Company accounts for all revenues from its operating leases in accordance with the revenue recognition accounting standard.
y. Convertible note:
Prior to January 1, 2021, the Company accounted for its convertible senior notes in accordance with ASC 470-20 "Debt with Conversion and Other Options". Pursuant to ASC Subtopic 470-20, issuers of certain convertible debt instruments, such as the convertible senior notes, that have a net settlement feature and may be settled wholly or partially in cash upon conversion are required to separately account for the liability (debt) and equity (conversion option) components of the instrument. The Company allocated the proceeds from issuance between the liability component and the embedded conversion option, or equity component. The liability component at issuance is recognized at fair value, based on the fair value of a similar instrument of similar credit rating and maturity that does not have a conversion feature. The equity component is based on the excess of the principal amount of the convertible senior notes over the fair value of the liability component and is recorded in additional paid-in capital. The equity component, net of issuance costs is presented within additional paid-in-capital and is not remeasured as long as it continues to meet the conditions for equity classification. The Company allocated the total issuance costs incurred to the liability and equity components of the convertible senior notes based on the same proportions as the proceeds from the notes.
In August 2020, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2020-06, Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (ASU 2020-06), which simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts in an entity’s own equity. Among other changes, ASU 2020-06 removes from GAAP the liability and equity separation model for convertible instruments with a cash conversion feature, and as a result, after adoption, entities will no longer separately present in equity an embedded conversion feature for such debt. Similarly, the embedded conversion feature will no longer be amortized into income as interest expense over the life of the instrument. Instead, entities will account for a convertible debt instrument wholly as debt unless (1) a convertible instrument contains features that require bifurcation as a derivative under Accounting Standards Codification ("ASC Topic 815"), Derivatives and Hedging, or (2) a convertible debt instrument was issued at a substantial premium. Additionally, ASU 2020-06 requires the application of the if-converted method to calculate the impact of convertible instruments on diluted earnings per share (EPS), which is consistent with the Company’s accounting treatment under the current standard. ASU 2020-06 is effective for fiscal years beginning after December 15, 2021, with early adoption permitted for fiscal years beginning after December 15, 2020, and can be adopted on either a fully retrospective or modified retrospective basis. The Company early adopted ASU 2020-06, effective January 1, 2021 on a modified retrospective basis.
The impact of the Company’s adoption of ASU 2020-06 on the balance sheet as of January 1, 2021 was an increase in long term debt, net of $128,972, a decrease in additional paid-in capital of $132,474, and a decrease in accumulated deficit of $3,502. Interest expense recognized in future periods will be reduced as a result of accounting for the convertible debt instrument as a single liability measured at its amortized cost. For additional information see Note 10 of these audited consolidated financial statements.
z. Recently Issued Accounting Pronouncements:
In November 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280 on an interim and annual basis. ASU 2023-07 is effective for fiscal years beginning after December 15, 2023, and for interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-07.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of adopting ASU 2023-09.
Note 3: Cash and Cash equivalents and Short-term investments
Cash equivalents include items almost as liquid as cash with maturity periods of three months or less when purchased, and short-term investments include items with maturity dates between three months and one year when purchased. As of December 31, 2023 and 2022, the Company’s cash and cash equivalents and short-term investments were composed of:
| December 31, 2023 | ||||||||
|---|---|---|---|---|---|---|---|---|
| Fair value level | Adjusted cost basis | Unrealized gains | Unrealized losses | Fair market value | Recorded basis | Cash and cash equivalents | Short-term investments (2) | |
| Cash | $9,955 | $— | $— | $9,955 | $9,955 | $9,955 | $— | |
| Money market funds | Level 1 | 227,166 | — | — | 227,166 | 227,166 | 227,166 | — |
| Certificate of deposits and term deposits | Level 2 | 153,169 | — | — | 153,169 | 153,169 | 3,700 | 149,469 |
| HTM securities (1) | ||||||||
| U.S. Treasury bills | Level 1 | $78,844 | $55 | $(110) | $78,789 | $78,844 | $— | $78,844 |
| Government and governmental agencies | Level 2 | $24,940 | $13 | $— | $24,953 | $24,940 | $— | $24,940 |
| Corporate debt securities | Level 2 | $416,542 | $486 | $(149) | $416,879 | $416,542 | $— | $416,542 |
| $520,326 | $554 | $(259) | $520,621 | $520,326 | $— | $520,326 | ||
| Total | $910,616 | $554 | $(259) | $910,911 | $910,616 | $240,821 | $669,795 | |
| December 31, 2022 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Fair value level · Adjusted cost basis · Unrealized gains · Unrealized losses · Fair market value · Recorded basis · Cash and cash equivalents · Short-term investments | |||||||||
| Cash | $9,697 | $— | $— | $9,697 | $9,697 | $9,697 | $— | ||
| Money market funds | Level 1 | 105,629 | — | — | 105,629 | 105,629 | 105,629 | — | |
| Certificate of deposits, notes and term deposits | Level 2 | 316,946 | — | — | 316,946 | 316,946 | — | 316,946 | |
| HTM securities (1) | |||||||||
| U.S. Treasury bills | Level 1 | 188,030 | 8 | (540) | 187,498 | 188,030 | — | 188,030 | |
| Government and governmental agencies | Level 2 | 44,357 | 12 | (12) | 44,357 | 44,357 | 44,357 | ||
| Corporate debt securities | Level 2 | 304,766 | 1,066 | (587) | 305,245 | 304,766 | — | 304,766 | |
| Total | $537,153 | $1,086 | $(1,139) | $537,100 | $537,153 | $— | $537,153 | ||
| $969,425 | $1,086 | $(1,139) | $969,372 | $969,425 | $115,326 | $854,099 | |||
(1) Changes in fair value of held-to-maturity ("HTM") securities are presented for disclosure purposes as required by ASC 320 "Investments — Debt Securities" and are recorded as finance expenses only if the unrealized loss is identified as a credit loss.
(2) Pursuant to a bank guaranty, $16,650 of short-term investments are pledged. See Note 12.
In November 2022, the Company transferred all of its AFS portfolio to HTM as part of the Company's investment strategy. Such transfers are made at fair value at the date of transfer, The net unrealized loss on these securities at the date of transfer was $911. These securities continue to be reported in accumulated comprehensive income (loss) and are amortized over the remaining lives of the securities as an adjustment to the yield. As of December 31, 2023 and 2022, the balance was fully amortized and $445, respectively.
In accordance with ASC No. 820, the Company measures its money market funds at fair value. The fair value of the money market funds and HTM securities, which is presented for disclosure purposes, is classified within Level 1 or Level 2. This is because these assets are valued using quoted market prices or alternative pricing sources and models utilizing market observable inputs.
As of December 31, 2023 and 2022, all investments and equivalents mature in one year or less.
Unrealized losses from debt securities are primarily attributable to changes in interest rates. The Company does not believe any remaining unrealized losses represent impairments based on the evaluation of available evidence.
Note 4: Receivables and prepaid expenses
The following table sets forth the Company’s receivables and prepaid expenses:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Advances to and receivables from suppliers | $10,564 | $7,151 |
| Government authorities | 5,261 | 12,389 |
| Prepaid expenses | 6,784 | 6,195 |
| Others | 68 | 224 |
| $22,677 | $25,959 | |
Note 5: Inventories
Inventories are stated at the lower of cost or net realizable value. The weighted average methodology is applied to determine cost. The following table sets forth the Company’s inventories:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Raw materials | $10,265 | $4,314 |
| Work in process | 9,796 | 9,321 |
| Finished goods | 18,091 | 15,741 |
| $38,152 | $29,376 | |
Note 6: Property and equipment, net
The following table sets forth the Company’s property and equipment, net:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Cost: | ||
| Computers and laboratory equipment | $31,383 | $24,804 |
| Office furniture | 4,023 | 2,627 |
| Production equipment | 7,641 | 3,513 |
| Land and building | $24,696 | $15,988 |
| Leasehold improvements | 11,696 | 9,346 |
| Total cost | $79,439 | $56,278 |
| Accumulated depreciation and amortization | (27,960) | (23,600) |
| Depreciated cost | $51,479 | $32,678 |
The Company capitalized software costs according to FASB's ASC 350-40, "Accounting for the Costs of Computer Software Developed or Obtained for Internal Use." Cumulative capitalization as of December 31, 2023 and 2022 was $18,241 and $13,192, respectively. Amortization of capitalized software costs for the years ended December 31, 2023, 2022 and 2021 was $1,274, $1,056 and $1,084, respectively.
Depreciation expense was $3,939, $3,105 and $2,812 for the years ended December 31, 2023, 2022 and 2021, respectively.
Write downs of $10, $344 and $10 were identified for the years ended December 31, 2023, 2022 and 2021, respectively.
Note 7: Field equipment, net
The following table sets forth the Company’s field equipment, net:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Field equipment | $38,237 | $36,727 |
| Accumulated depreciation | (26,853) | (24,043) |
| Field equipment, net | $11,384 | $12,684 |
Depreciation expense was $5,756, $6,463 and $6,355 for the years ended December 31, 2023, 2022 and 2021, respectively. Write downs of $483, $611 and $639 were identified for the years ended December 31, 2023, 2022 and 2021, respectively.
Note 8: Other payables, lease liabilities and accrued expenses
The following table sets forth the Company’s other payables and accrued expenses:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Employees and payroll accruals | $51,044 | $40,778 |
| Deferred revenues | 16,224 | 18,028 |
| Government authorities | 9,134 | 8,660 |
| Other | 8,322 | 6,114 |
| $84,724 | $73,580 | |
Note 9: Employee benefit obligations
The Company's liability in respect of the Swiss Plan (see Note 2(u)) is the projected benefit obligation calculated using the projected unit credit method. The projected benefit obligation as of December 31, 2023 represents the actuarial present value of the estimated future payments required to settle the obligation that is attributable to employee service rendered before that date. Swiss Plan assets are recorded at fair value. Pension expense is presented in the payroll expenses in the various functions in which the employees are engaged. Actuarial gains and losses arising from differences between the actual and the expected return on the Swiss Plan assets are recognized in accumulated other comprehensive income (loss) and amortized over the requisite service period. The Swiss Plan is part of a collective pension foundation of pooled investments managed by a top tier insurance company. The Company and the employees pay retirement contributions, which are defined as a percentage of the employees’ covered salaries.The basis for the determination of the interest on employee’s savings account is the return on plan assets, considering legal minimum requirements. The targeted allocation for these funds is as follows:
| Asset Allocation by Category as of December 31, 2023: | Assetallocation (%) |
|---|---|
| Asset Category: | |
| Debt Securities | 33% |
| Real Estate | 25% |
| Equity Securities | 34% |
| Others | 8% |
| Total | 100% |
The following table sets forth the Swiss Plan’s funded status and amounts recognized in the consolidated financial statements for the year ended December 31, 2023 and 2022:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Change in Benefit Obligation | ||
| Projected benefit obligation at beginning of year | $29,435 | $29,975 |
| Interest cost | 850 | 62 |
| Company service cost | 2,992 | 2,725 |
| Employee contributions | 2,517 | 1,631 |
| Prior service cost | (768) | 484 |
| Benefits paid | 6,726 | 423 |
| Actuarial loss | 9,305 | (5,865) |
| Projected benefit obligation at end of year | $51,057 | $29,435 |
| Change in Plan Assets | ||
| Fair value of plan assets at beginning of year | $25,531 | $25,967 |
| Actual return on plan assets | 4,699 | (4,937) |
| Employer contributions | 3,776 | 2,446 |
| Employee contributions | 2,518 | 1,631 |
| Benefits paid | 6,726 | 424 |
| Fair value of plan assets at end of year | $43,250 | $25,531 |
| Funded Status at End of year | ||
| Excess of obligation over assets | $7,807 | $3,904 |
| Change in Accrued Benefit Liability | ||
| Accrued benefit liability at beginning of year | $(3,904) | $(4,008) |
| Company contributions made during year | 3,776 | 2,446 |
| Net periodic benefit cost for year | (3,058) | (2,078) |
| Net decrease (increase) in accumulated other comprehensive loss | (4,621) | (264) |
| Accrued benefit liability at end of year | $(7,807) | $(3,904) |
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Non-current plan assets | $43,250 | $25,531 |
| Non-current liability | 51,057 | 29,435 |
| Accrued benefit liability at end of year | $(7,807) | $(3,904) |
| Projected Benefit Payments | ||
| Projected year 1 | $1,138 | $539 |
| Projected year 2 | 1,102 | 744 |
| Projected year 3 | 1,546 | 983 |
| Projected year 4 | 1,577 | 1,065 |
| Projected year 5 | 958 | 578 |
| Projected years 6-10 | 20,127 | 16,940 |
The fair value of the plan assets is the estimated cash surrender value of the insurance contract at December 31, 2023. The level of inputs used to measure fair value was Level 2.
| Year endedDecember 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Net Periodic Benefit Cost | ||
| Service cost | $2,992 | $2,725 |
| Interest cost (income) | 850 | 62 |
| Expected return on plan assets | (1,210) | (701) |
| Amortization of actuarial (gain) loss | 94 | 117 |
| Amortization of prior service costs | (54) | (99) |
| Total net periodic benefit cost | $2,672 | $2,104 |
| Weighted average assumptions: | ||
| Discount rate as of December 31 | 1.40% | 2.30% |
| Expected long-term rate of return on assets | 3.00% | 3.50% |
| Rate of compensation increase | 1.50% | 1.50% |
| Mortality and disability assumptions (*) | BVG 2020 GT | BVG 2020 GT |
(*) Mortality data used for actuarial calculation.
Note 10: Long-term debt, net
The following table sets forth the Company’s long-term debt, net:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| 0% Convertible Senior Notes (a) | $568,822 | $565,509 |
| Credit facility (b) | — | — |
| $568,822 | $565,509 | |
a. Convertible Notes
On November 5, 2020, the Company issued $575,000 aggregate principal amount of 0% Convertible Senior Notes due 2025 (the “Notes”). The net proceeds from the offering were approximately $558,400.
The Notes are senior unsecured obligations of the Company. The Notes do not bear regular interest, and the principal amount of the Notes will not accrete. Special interest, if any, payable in accordance with the terms of the Notes will be payable in cash semi-annually in arrears on May 1 and November 1 of each year, beginning on May 1, 2021. The Notes mature on November 1, 2025, unless earlier repurchased, redeemed or converted.
The Notes are convertible into cash, the Company’s ordinary shares or a combination of cash and the Company’s ordinary shares at the Company’s election at an initial conversion rate of 5.9439 ordinary shares per $1,000 principal amount of the Notes, which is equivalent to an initial conversion price of approximately $168.24 per ordinary share.
In January 2021, the Company irrevocably elected to settle all conversions of Notes by a combination of cash and the Company's ordinary shares and that the cash portion per $1,000 principal amount of Notes for all conversion settlements shall be $1,000. Accordingly, from and after the date of the election, upon conversion of any Notes, holders of Notes will receive, with respect to each $1,000 principal amount of Notes converted, cash in an amount up to $1,000 and the balance of the conversion value, if any, in ordinary shares (the "Conversion Shares").
The Notes are not redeemable prior to November 6, 2023, except in the event of certain tax law changes. The Company may redeem for cash all or any portion of the Notes, at the Company’s option, on or after November 6, 2023 if the last reported sale price of the Company’s ordinary shares has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which the Company provides notice of redemption at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid special interest, if any, to, but excluding, the redemption date. No sinking fund is provided for the Notes.
Prior to the close of business on the business day immediately preceding August 1, 2025, the Notes are convertible at the option of the holders only upon the satisfaction of certain conditions and during certain periods as described below and if the Company exercises its right to redeem the Notes as permitted or required by the Indenture as described below. On or after August 1, 2025 until the close of the business on the business day immediately preceding the maturity date, holders may convert all or any portion of their Notes at the conversion rate at any time irrespective of the foregoing conditions.
If holders of at least $3,000 aggregate principal amount of the Notes provide the Company with reasonable evidence that the trading price per $1,000 principal amount of Notes (the “Note Trading Price”) on any trading day would be less than 98% of the product of the last reported sale price of the Ordinary Shares on such trading day and the conversion rate on such trading day (the “Trigger Note Price”), the Company shall follow the process for obtaining the Note Trading Price as provided in the Indenture on a daily basis until the Note Trading Price exceeds the Trigger Notice Price. During this time, if during anyfive consecutive trading day period (the “Measurement Period”) the Note Trading Price is less than 98% of the Trigger Notice Price, the Company must notify the holders and the trustee of such an event and the holders may convert their Notes into Ordinary Shares at any time during thefive business day period immediately after.
If the Company intends to (i) issue warrants/rights/options to existing shareholders with an exercise price less than theten-day trailing last trading price average or (ii) distribute to shareholders assets, securities or rights with a value per share greater than 10% of the last reported trading price, then the Company must give holders of the Notes thirty-five (35) trading days’ notice of such event, at which time a holder may convert their Notes during such 35 trading day period (or until the Company revokes its decision to issue/distribute the securities, whichever comes sooner).
In addition, upon the occurrence of a fundamental change (as defined in the indenture), holders may require the Company to repurchase for cash all or any portion of their Notes at a fundamental change repurchase price equal to 100% of the principal amount of the Notes to be repurchased, plus accrued and unpaid special interest, if any, to, but excluding, the fundamental change repurchase date. In addition, following certain corporate events that occur prior to the maturity date or if the Company delivers a notice of redemption, the Company will, in certain circumstances, increase the conversion rate for a holder who elects to convert its Notes in connection with such a corporate event or notice of redemption, as the case may be.
As of December 31, 2023, the conditions allowing holders of the Notes to convert were not met. The Notes are therefore not convertible as of December 31, 2023 and are classified as long-term liability.
The net carrying amount of the liability of the Convertible Notes (see note 2(y) for additional information) as of December 31, 2023 and 2022 are as follows:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Liability component, net: | ||
| Principal amount | $575,000 | $575,000 |
| Unamortized issuance costs | (6,178) | (9,491) |
| Net carrying amount of liability component (1) | $568,822 | $565,509 |
(1) An effective interest rate determines the fair value of the Notes, therefore they are categorized as Level 3 in accordance with ASC 820, "Fair Value Measurements and Disclosures." The estimated fair value of the Net carrying amount of liability component of the Notes as of December 31, 2023 and 2022 were $515,962 and $455,091, respectively.
The net carrying amount of the liability is represented by the principal amount of the Notes, less total issuance costs plus any amortization of issuance costs. The total issuance costs upon issuance of the Notes were $16,561 and are amortized to interest expense using the effective interest rate method over the contractual term of the Notes. Interest expense is recognized at an annual effective interest rate of 0.59% over the contractual term of the Notes. Amortization of debt issuance costs, included in finance expenses, for the years ended December 31, 2023, 2022 and 2021 was $3,313, $3,293, and $3,339, respectively.
b. 2020 Credit Facility
On November 6, 2020, the Company entered into athree-year $150.0 million senior secured revolving credit facility with a syndicate of relationship banks (the "2020 Credit Facility").
On February 17, 2023, the Company gave irrevocable notice to the administrative agent under the 2020 Credit Facility that the Company terminated all commitments, effective February 22, 2023. This effectively terminated the 2020 Credit Facility, as the Company's ability to borrow and the Company's obligations to comply with all covenants ended on such date. The liens and guaranties in favor of the lenders are released. There wereno early termination fees payable and as of February 22, 2023 the Company hadno outstanding balance borrowed under the 2020 Credit Facility. On November 6, 2023, the 2020 Credit Facility expired pursuant to its terms.
As of December 31, 2023, the Company hadno outstanding balance borrowed or any other liability outstanding under the 2020 Credit Facility.
Note 11: Other long-term liabilities
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Leasehold improvements financing and other | $— | $72 |
| Unrecognized tax benefits (Note 14(e)) | 18 | 76 |
| $18 | $148 | |
Note 12: Commitments and contingent liabilities
a. Operating leases
The facilities of the Company are leased under various operating lease agreements for periods ending no later than 2044. The Company also has the option to extend the term of certain facility lease agreements and these are included in the calculation of right-of-use assets. The Company also leases motor vehicles under various operating leases, which expire on various dates, the latest of which is in 2026.
Under ASC 842, all leases with durations greater than 12 months, including non-cancelable operating leases, are recognized on the balance sheet. The aggregated present value of lease payments is recorded as a long-term asset titled right-of-use assets. The corresponding lease liabilities are split between other payables and long-term lease liabilities, and as of December 31, 2023, are as follows:
| December 31, | |
|---|---|
| 2023 | |
| Future minimum lease payments: | |
| 2024 | $8,748 |
| 2025 | 8,126 |
| 2026 | 6,558 |
| 2027 | 5,315 |
| 2028 | 4,553 |
| Thereafter | 9,039 |
| Total future minimum lease payments | $42,339 |
|---|---|
| Less imputed interest | (6,695) |
| Net present value of future minimum lease payments | $35,644 |
| Current year end | |
| Short-term lease liabilities | $8,224 |
| Long-term lease liabilities | 27,420 |
| Net present value of future minimum lease payments | $35,644 |
| Weighted average of remaining operating lease term (years) | 6.68 |
| Weighted average of operating lease discount rate | 5.59% |
Lease and rental expense for the years ended December 31, 2023, 2022 and 2021 was $8,196, $7,108, and $7,349, respectively.
b. Bank guarantee and pledges
As of December 31, 2023 and 2022 the Company pledged bank deposits of $2,848 and $2,296, respectively, to cover bank guarantees in respect of its leases of operating facilities and obtained guarantees by the bank for the fulfillment of the Company’s lease commitments of $3,216 and $2,459, respectively. In addition, €15,000 ($16,650) of the Company's short term investments are pledged to a bank as guarantee for the Company's due execution of cash concentration agreements.
c. Zai License and Collaboration Agreement
On September 10, 2018, the Company entered into the Zai Agreement. Under the Zai Agreement, the Company granted Zai exclusive rights to commercialize the Company's Products in the field of oncology in China, Hong Kong, Macau and Taiwan ("Greater China"). The Zai Agreement also established a development partnership for the Company's Products in multiple solid tumor indications. In partial consideration for the license grant to Zai for Greater China, the Company was entitled to a non-refundable, up-front license fee in the amount of $15,000 (the "License Fee"). The Zai Agreement also provides for certain development, regulatory and commercial milestone payments totaling up to $78,000. Furthermore, pursuant to the Zai Agreement, Zai will pay the Company tiered royalties at percentage rates from 10 up to the mid-teens on the net sales of the licensed products in Greater China. Zai is purchasing licensed products for commercial use exclusively from the Company at the Company’s fully burdened manufacturing cost.
d. Legal Proceedings
In June 2023, a putative class action lawsuit was filed against the Company, its Executive Chairman and its Chief Executive Officer. The complaint, later amended to add our Chief Financial Officer as a defendant, purports to be brought on behalf of a class of persons and/or entities who purchased or otherwise acquired ordinary shares of the Company from January 5, 2023 through June 5, 2023, and alleges material misstatements and/or omissions in the Company’s public statements with respect to the results from its phase 3 LUNAR clinical trial. The Company believes that the action is without merit and plans to defend the lawsuit vigorously. As of December 31, 2023, the Company has not accrued any amounts in respect of this claim, as it believes liability is not probable and the amount of any potential liability cannot be reasonably estimated.
e. Purchase Obligations
As of December 31, 2023, the Company has $43,075 in purchase obligations with certain of its suppliers.
Note 13: Revenue recognition
a. Net revenues
The Company’s net revenues by geographic region, based on the patient’s location are summarized as follows:
| Year ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| United States | $349,743 | $406,894 | $353,110 |
| International markets: | |||
| Germany | 60,210 | 46,120 | 93,939 |
| Japan | 31,668 | 32,781 | 34,640 |
| Other international markets | 44,493 | 30,713 | 30,577 |
| International markets - Total | 136,371 | 109,614 | 159,156 |
| Greater China (1) | 23,224 | 21,332 | 22,765 |
| Total net revenues | $509,338 | $537,840 | $535,031 |
(1) For additional information, see c below.
The company's net revenues by performance period are as follows:
| Year ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Net revenues recognized in the reporting period from performance obligations satisfied in: | |||
| Reporting period | $492,089 | $480,266 | $508,337 |
| Previous periods | 17,249 | 57,574 | 26,694 |
| Total net revenues | $509,338 | $537,840 | $535,031 |
b. Contract balances
The following table provides information about trade receivables, unbilled receivables and contract liabilities from contracts with customers::
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Trade receivables | $56,970 | $84,069 |
| Unbilled receivables | $4,251 | $2,192 |
| Deferred revenues (short-term contract liabilities) | $(16,224) | $(18,028) |
| Deferred revenues (long-term contract liabilities) | $— | $(2,878) |
During the years ended December 31, 2023, 2022and 2021, the Company recognized $18,028, $17,762 and $17,765, respectively, which were included in the deferred revenues (short-term contract liability) balance at January 1, 2023 , 2022 and 2021.
c. Zai agreement:
The Company recognizes revenue pursuant to the License Agreement with Zai (see note 12) in accordance with ASC 606, "Revenue Recognition from Customers." The License Fee was deferred and recognized over the performance period commencing September 10, 2018 ("Zai Performance Period"). The potential development and regulatory milestones will be included in the transaction price when the Company concludes that achievement of the milestones is probable, and that recognition of revenue related to the milestones will not result in a significant reversal in amounts recognized in future periods, and as such have been excluded from the transaction price until such probability is achieved. Revenue from royalty payments are recognized in accordance with ASC 606 in the period accrued. Revenues from sales of product or rendering services are recognized upon shipping the products or rendering the services and satisfying the performance obligation.
During the year ended December 31, 2020, the Company triggered milestone payments of $10,000 in the aggregate, which, along with the License Fee, are deferred and recognized over the remainder of the Zai Performance Period on a straight-line basis. For the three years ended December 31, 2023, no additional milestones were included in the transaction price.
Note 14: Income taxes
a. Tax provision:
As of January 1, 2022, the effective place of daily management and control of the Company moved to Switzerland and the Company has become a Swiss tax resident. As a result, the income tax disclosures have been presented in accordance with the Company’s current country of tax residency.
Income (loss) before income taxes is as follows:
| Year ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Swiss | $(281,685) | $(269,621) | $(145,591) |
| Non-Swiss | 89,945 | 187,775 | 93,516 |
| Total income (loss) before income taxes | $(191,740) | $(81,846) | $(52,075) |
The provision (benefit) for income taxes from continuing operations is comprised of:
| Year ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Current: | |||
| Swiss | $2,163 | $469 | $281 |
| Non-Swiss | 13,140 | 10,219 | 5,995 |
| Total current | $15,303 | $10,688 | $6,276 |
| Deferred: | |||
| Swiss | $— | — | $— |
| Non-Swiss | — | — | — |
| Total deferred | — | — | — |
| Total income tax provision | $15,303 | $10,688 | $6,276 |
b. Theoretical tax
The Company's effective tax rate is affected by the tax rates in the various jurisdictions in which the Company operates. Under Swiss law, the Company is subject to income tax at the federal level at a statutory rate of 8.5% as well as at the cantonal and communal levels, resulting in an aggregate corporate tax rate of 11.9%.
For purposes of comparability, the Company used the Swiss federal statutory rate for the 2023, 2022 and 2021 tax years when presenting the Company's reconciliation of the income tax provision.
A reconciliation of the provision for income taxes compared with the amounts at the Swiss rate was:
| Year ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Income (loss) before income taxes | $(191,740) | $(81,846) | $(52,075) |
| Swiss federal statutory rate | 8.5% | 8.5% | 8.5% |
| Income tax at federal Swiss rate | $(16,298) | $(6,957) | $(4,426) |
| Change in valuation allowance | 13,427 | (14,238) | 11,643 |
| Foreign taxes rate differential | 10,620 | 25,716 | 1,601 |
| Return to provision true-ups | 10,854 | (1,020) | 2,416 |
| Research and development credits | (6,483) | (4,898) | (2,216) |
| Share based compensation | 2,332 | 5,318 | (4,636) |
| Withholding Taxes | 435 | 548 | 273 |
| Effect of tax law change | 6 | 5,681 | — |
| Other | 410 | 538 | 1,621 |
| Income tax | $15,303 | $10,688 | $6,276 |
| Effective tax rate | (8.0)% | (13.1)% | (12.1)% |
c. Deferred income tax
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets and liabilities are as follows:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Deferred tax assets: | ||
| Unamortized intangible assets | $153,450 | $153,450 |
| Net operating loss carryforwards | $99,743 | $65,472 |
| Impact of revenue recognition | $79,934 | $82,972 |
| Share based compensation | $32,639 | $30,009 |
| Lease liabilities | $8,128 | $5,846 |
| Capitalized research and development | $2,783 | $16,730 |
| Research and development credits | $1,615 | $8,992 |
| Other temporary differences | $7,809 | $7,089 |
| Total gross deferred tax assets | $386,101 | $370,560 |
| Less: valuation allowance | (375,375) | (361,358) |
| Total deferred tax assets | 10,726 | 9,202 |
| Deferred tax liabilities: | ||
| Right of use assets | 7,962 | 5,785 |
| Fixed assets | 1,914 | 1,730 |
| Other liabilities | 850 | 1,687 |
| Total gross deferred tax liabilities | $10,726 | $9,202 |
| Net deferred taxes assets (liability) | $— | $— |
d. Carryforward loss:
In Switzerland, the Company had $821,963 of net operating carryforwards (NOLs) available at the Federal level, of which $794,203 are also available at the cantonal and communal level. These NOLs expire from 2026 through
- Additionally, the Company had $29,357 of non-Swiss NOLs as of December 31, 2023, of which $1,968 carry forward indefinitely,and the remainder expire from 2024 through 2042.
e. Uncertain tax benefits:
A reconciliation of the beginning and ending balances of uncertain tax benefits is as follows:
| December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Balance at beginning of the year | $76 | $154 | $297 |
| Additions (reductions) for taxes positions related to prior years | (58) | (78) | (143) |
| Balance at the end of the year | $18 | $76 | $154 |
The Company recognizes interest and penalties related to unrecognized tax benefits in tax expense. During the years ended December 31, 2023, 2022 and 2021, the Company accrued $2, $2 and $5, respectively, for interest and penalties expenses related to uncertain tax positions.
The Company files income tax returns in the Switzerland and various foreign jurisdictions. Currently, the Company is under examination by the tax authorities in Israel for the tax years 2019 and 2020 and is not under examination by any other tax authority. Additional tax years within the period from 2019 to 2022 remain subject to examination by Swiss, U.S. and other tax authorities.
Note 15: Share capital
Share capital is composed as follows:
| Issued and outstandingNumber of sharesDecember 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Ordinary shares no par value | 107,075,754 | 105,049,411 |
Equity incentive plans:
Stock option plan
Until the IPO in October 2015, the Company maintained and granted option awards under the 2003 Share Option Plan (the "2003 Plan") and the 2013 Equity Incentive Share Option Plan (the "2013 Plan") for the Company’s officers, directors, employees and advisors. The 2003 Plan and the 2013 Plan terminated as of the IPO as to future awards, but they continue to govern option awards previously granted thereunder.
In September 2015, the Company adopted the 2015 Omnibus Incentive Plan (the "2015 Plan"). The Company’s shareholders approved the 2015 Plan in September 2015. Under the 2015 Plan, the Company can issue various types of equity compensation awards such as restricted shares, performance shares, restricted stock units ("RSUs"), performance share units ("PSUs"), long-term cash award and other share-based awards. Options granted under the 2015 Plan generally have a vesting period oftwo orfour years and expireten years after the date of grant. RSUs granted under the 2015 Plan vest in equal installments overtwo orthree years. PSUs granted under the 2015 Plan generally vest have a vesting period between three andsix years, as performance targets are attained. Options, RSUs and PSUs granted under the 2015 Plan that are canceled before expiration become available for future grants.
On December 31, 2023, in accordance with the terms of the 2015 Plan, the number of shares available for issuance under the 2015 Plan automatically increased by 4% of the Company’s outstanding ordinary shares as of December 30, 2023. As a result, the number of shares available for issuance under the 2015 Plan increased from 43,465,227 shares to 47,743,427 shares. As of December 31, 2023,22,896,258 ordinary shares are available for grant under the 2015 Plan.
Employee Stock Purchase Plan
In September 2015, the Company adopted an ESPP to encourage and enable eligible employees to acquire ownership of the Company’s ordinary shares purchased through accumulated payroll deductions on an after-tax basis. The ESPP is intended to be an "employee stock purchase plan" within the meaning of Section 423 of the Code and the provisions of the ESPP will be construed in a manner consistent with the requirements of such section. The Company began its offerings under the ESPP on August 1, 2016. The Company issued 202,492 ordinary shares for the plan period from January 1, 2023 through December 31, 2023.
The terms of the ESPP provide that on December 31 of each year, the number of shares available for purchase by eligible employees who participate in the ESPP automatically increases by 1% of the Company’s outstanding ordinary shares outstanding, unless the Company determines that such an increase is not necessary. The Company determined that an such increase was not necessary and no such increase took place. As of December 31, 2023,5,735,791 ordinary shares are available for offering under the ESPP.
The fair value of share-based awards was estimated using the Black-Scholes model for all equity grants and for market condition awards. The Company also applied the Monte-Carlo simulation model, with the following underlying assumptions:
| Year ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Stock Option Plans | |||
| Expected term (years) | 5.50-6.00 | 5.33-5.83 | 5.50-6.00 |
| Expected volatility | 63%-70% | 60%-62% | 60%-63% |
| Risk-free interest rate | 3.48%-4.79% | 1.58%-4.23% | 0.78%-1.27% |
| Dividend yield | 0.00% | 0.00% | 0.00% |
| ESPP | |||
| Expected term (years) | 0.50 | 0.50 | 0.50 |
| Expected volatility | 56%-122% | 51%-77% | 54%-81% |
| Risk-free interest rate | 4.76%-5.38% | 0.19%-2.52% | 0.05%-0.09% |
| Dividend yield | 0.00% | 0.00% | 0.00% |
A summary of the status of the Company’s options to purchase ordinary shares as of December 31, 2023 and changes during the year ended on that date is presented below:
| Year ended December 31, 2023 | |||
|---|---|---|---|
| Number ofoptions | Weightedaverageexerciseprice | Aggregateintrinsicvalue | |
| Outstanding at beginning of year | 8,786,364 | $37.27 | |
| Granted | 1,192,916 | 55.65 | |
| Exercised | (827,078) | 13.73 | |
| Forfeited and cancelled | (612,695) | 65.82 | |
| Outstanding at end of year | 8,539,507 | $40.07 | $10,631 |
| Exercisable options | 6,724,151 | $31.60 | $10,271 |
A summary of the status of the Company’s RSUs and PSUs as of December 31, 2023 and changes during the year ended on that date is presented below:
| Year ended December 31, 2023 | |||
|---|---|---|---|
| Number ofRSUs/PSUs | Weightedaveragegrant datefair valueprice | Aggregateintrinsicvalue | |
| Unvested at beginning of year | 5,377,459 | $66.87 | |
| Granted | 1,878,261 | 57.60 | |
| Vested | (996,773) | 84.24 | |
| Forfeited and cancelled | (445,881) | 72.12 | |
| Unvested at end of year (1) | 5,813,066 | $60.52 | $86,790 |
(1) Includes PSUs that have a mix of service, market and other milestone performance vesting conditions which are vested upon achievements of market and performance conditions which are not probable, as of December 31, 2023, in accordance with ASC 718 as follows:
| December 31, 2023 | |||
|---|---|---|---|
| Number ofPSUs · Fair value at grant date per PSU · Total fair value at grant date | |||
| 2,703,852 | $48.16 | $130,218 | |
| 220,533 | 76.97 | 16,974 | |
| 249,402 | 80.59 | 20,099 | |
| 15,210 | 87.66 | 1,333 | |
| 10,532 | $94.94 | $1,000 | |
| 161,912 | 114.26 | 18,500 | |
| 3,361,441 | $188,127 | ||
These PSUs will be expensed over the performance period when the vesting conditions become probable in accordance with ASC 718.
The total equity-based compensation expense related to all of the Company’s equity incentive plans recognized for the years ended December 31, 2023, 2022 and 2021, was comprised as follows:
| Year ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Cost of revenues | $6,587 | $4,690 | $3,471 |
| Research, development and clinical studies | 31,827 | 30,790 | 27,597 |
| Sales and marketing | 35,968 | 28,826 | 22,673 |
| General and administrative | 41,226 | 42,649 | 41,159 |
| Total share-based compensation expense | $115,608 | $106,955 | $94,900 |
As of December 31, 2023, unamortized share-based compensation costs amounted to $98,565 and are expected to be recognized over a weighted average period of approximately 1.64 years.
The weighted average grant date exercise price of the Company’s options granted during the years ended December 31, 2023, 2022 and 2021 were $55.65, $78.69 and $149.96 per share, respectively.
The weighted average grant date fair value of the Company’s options granted during the years ended December 31, 2023, 2022 and 2021 were $33.77, $44.70 and $81.93 per share, respectively.
The weighted average grant date fair values of the Company’s options forfeited and cancelled during the years ended December 31, 2023, 2022 and 2021 were $36.54, $86.79 and $62.77, respectively.
The fair values of the Company’s RSUs and PSUs vested during the years ended December 31, 2023, 2022 and 2021 were $83,968, $44,818 and $29,960, respectively.
The aggregate intrinsic values for the options exercised during the years ended December 31, 2023, 2022 and 2021 were $49,679, $26,436 and $143,695, respectively. The aggregate intrinsic value is calculated as the difference between the per share exercise price and the deemed fair value of the Company’s ordinary shares for each share subject to an option multiplied by the number of shares subject to options at the date of exercise. The Company deemed the fair value of the Company’s ordinary shares to be $14.93, $73.35 and $75.08 per share as of December 31, 2023, 2022, and 2021, respectively.
Options outstanding as of December 31, 2023 are as follows:
| Exercise price | Numberof optionsoutstanding | Weightedaverageremainingcontractualterm | Numberof optionsexercisable | Weightedaverageremainingcontractualterm |
|---|---|---|---|---|
| $ · (years) · (years) | ||||
| 0.00 - 10.00 | 495,359 | 2.94 | 495,359 | 2.94 |
| 10.01 - 20.00 | 2,613,654 | 3.58 | 2,392,761 | 3.00 |
| 20.01 - 30.00 | 1,584,459 | 3.41 | 1,584,459 | 3.41 |
| 30.01 - 40.00 | 365,769 | 6.27 | 237,310 | 4.48 |
| 40.01 - 60.00 | 1,091,894 | 5.47 | 1,035,401 | 5.25 |
| 60.01 - 100.00 | 2,019,484 | 7.84 | 776,561 | 6.75 |
| 100.01 - 160.00 | 359,626 | 7.20 | 193,920 | 7.16 |
| 160.01 - 220.00 | 9,262 | 7.42 | 8,380 | 7.43 |
| 8,539,507 | 5.0 | 6,724,151 | 4.1 | |
Note 16: Financial (expenses) income, net
The following table sets forth the Company’s total financial expenses, net:
| Year ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Financial expenses: | |||
| Interest expense | $(6) | $(41) | $(101) |
| Revolving credit facility fee | (58) | (558) | (588) |
| Amortization of discount and issuance costs | (3,313) | (3,293) | (3,339) |
| Foreign currency translation losses | (797) | (3,523) | (4,032) |
| Bank charges and others | (732) | (698) | (779) |
| $(4,906) | $(8,113) | $(8,839) | |
| Financial income: | |||
| Amortization of investments premium | $26,397 | $4,829 | $306 |
| Interest income | 19,639 | 10,961 | 791 |
| $46,036 | $15,790 | $1,097 | |
| Total financial (expenses) income, net | $41,130 | $7,677 | $(7,742) |
Note 17: Basic and diluted net income (loss) per share
Basic net income (loss) per share is computed based on the weighted average number of ordinary shares outstanding during each period. Diluted net income per share is computed based on the weighted average number of ordinary shares outstanding during the period, plus potential dilutive shares (deriving from options, RSUs, PSUs, convertible notes and the ESPP) considered outstanding during the period, in accordance with ASC 260-10, as determined under the treasury stock method.
The following table sets forth the computation of the Company’s basic and diluted net loss per ordinary share:
| Year ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Net income (loss) attributable to ordinary shares as reported | $(207,043) | $(92,534) | $(58,351) |
| Net income (loss) used in computing basic net income (loss) per share | $(207,043) | $(92,534) | $(58,351) |
| Adjustment needed in calculating diluted net income (loss) per share | — | — | — |
| Net income (loss) used in computing diluted net income (loss) per share | $(207,043) | $(92,534) | $(58,351) |
| Weighted average number of ordinary shares used in computing basic and diluted net income (loss) per share | 106,391,178 | 104,660,476 | 103,433,274 |
| Potentially dilutive shares that were excluded from the computation of basic and diluted net income (loss) per share: | |||
| Options | 6,950,781 | 6,387,275 | 7,201,495 |
| RSUs and PSUs | 1,423,377 | 822,421 | 1,017,799 |
| Conversion of convertible note | — | — | 262,903 |
| ESPP | 161,627 | 62,910 | 42,725 |
| Weighted anti-dilutive shares outstanding which were not included in the diluted calculation | 8,535,785 | 7,272,606 | 8,524,922 |
| Basic and diluted net income (loss) per ordinary share | $(1.95) | $(0.88) | $(0.56) |
Note 18: Supplemental information
The Company operates asone reporting segment. The following table presents long-lived assets by location:
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| United States | $41,634 | $30,012 |
| Israel | 8,317 | 7,180 |
| Switzerland | 7,733 | 5,084 |
| Others | 5,179 | 3,086 |
| Total long-lived assets | $62,863 | $45,362 |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.