SI-BONE Inc
For the period ended Dec 31, 2023. Filed Feb 27, 2024.
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FY2023 · Filed Feb 27, 2024
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Notes to Consolidated Financial Statements
- The Company and Nature of Business
SI-BONE, Inc. (the “Company”) was incorporated in the state of Delaware on March 18, 2008 and is headquartered in Santa Clara, California. The Company is a medical device company that has pioneered a proprietary minimally invasive surgical implant system to fuse the sacroiliac joint for treatment of musculoskeletal disorders of the sacropelvic anatomy. The Company introduced its first generation iFuse implant in 2009 in the United States, in 2010 in certain countries in the European Union, and in 2015 in certain countries in the rest of the world. The second generation iFuse implant, iFuse 3-D, was introduced in 2017 followed by iFuse-TORQ in 2021 and iFuse Bedrock Granite in 2022.
In May 2023, the Company received a total of $83.7 million of net proceeds after deducting the underwriting discounts and commissions from the offering of 3,775,000 shares of the Company’s common stock and the exercise of underwriter's option to purchase from the Company an additional 566,250 shares of the Company's common stock, at a public offering price of $22.00 per share. Of these shares,272,753 shares were offered by a selling stockholder, and the Company did not receive any proceeds from the sale by the selling stockholder.
Risks and Uncertainties
The Company is subject to uncertainties related to liquidity, the ability to meet covenants and access to funding for its capital needs as the financial service industry has experienced disruptions characterized by the bankruptcy, failure, collapse or sale of various financial institutions. The Company’s cash and cash equivalents are primarily invested in deposits and money market accounts with two major financial institutions in the U.S. Deposits in these banks may exceed the federally insured limits or any other insurance provided on such deposits, if any. The Company had accounts with Silicon Valley Bank (“SVB”). On March 10, 2023, California regulators shut down SVB and the FDIC was appointed as SVB’s receiver. On March 26, 2023, the FDIC announced that it had entered into a purchase and assumption agreement with First-Citizens Bank & Trust Company (“First-Citizens”) under which all deposits of the former Silicon Valley Bank were assumed by First-Citizens. First-Citizens acquired the rights as lender under the Company’s Loan and Security Agreement as amended. To date, the Company has not experienced any losses on its deposits of cash, cash equivalents and marketable securities and continues to have access to these funds. As such the Company's future results of operations and liquidity could be adversely impacted by a variety of factors including those discussed in the section entitled "Risk Factors" in this report. As of the date of issuance of these consolidated financial statements, the extent to which the current macroeconomic environment may materially impact the Company's financial condition, liquidity, or results of operations remains uncertain.
- Summary of Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The accompanying consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”). The consolidated financial statements include the Company's accounts, as well as those of the Company's wholly-owned international subsidiaries. All inter-company accounts and transactions have been eliminated.
Use of Estimates
The preparation of 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 assets and liabilities as of the date of the financial statements and the reported amounts of revenue and expenses during the reporting period. Significant accounting estimates and management judgments reflected in the consolidated financial statements primarily includes the fair value of performance-based restricted stock unit awards. Estimates are based on historical experience, where applicable and other assumptions believed to be reasonable by the management. Actual results could differ from those estimates.
Reclassification of prior year presentation
Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications are limited to the consolidated statements of cash flows and have no effect on the reported results of operations.
Segments
The Company's chief operating decision makers are the Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”). The CEO and the CFO review financial information presented on a consolidated basis, accompanied by information about revenue by geographic region, for purposes of evaluating financial performance. The Company has one business activity and there are no segment managers who are held accountable for operations, operating results or plans for levels or components below the consolidated unit level. Accordingly, the Company has determined that it has a single reportable and operating segment structure.
The Company derives substantially all of its revenue from sales to customers in the United States Revenue by geography is based on billing address of the customer. International revenue accounted for less than 10% of the total revenue during the periods presented. Long-lived assets held outside the United States are immaterial. Following table summarizes the Company's revenue by geography:
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| (in thousands) | ||
| United States | $130,621 | $98,751 |
| International | 8,265 | 7,658 |
| $138,886 | $106,409 | |
Foreign Currency
The Company’s foreign subsidiaries use local currency as their functional currency. Assets and liabilities are translated at exchange rates prevailing at the balance sheet dates. Revenue, costs and expenses are translated into U.S. dollars using average exchange rates for the period. Gains and losses from foreign currency translation are recorded as a component of accumulated other comprehensive income (loss). Gains and losses from foreign currency transactions are recognized as a component of other income (expense), net.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash and marketable securities. The Company’s cash and marketable securities are deposited with financial institutions in the United States and in Europe. The majority of the Company’s cash and marketable securities are deposited with a single financial institution in the United States Deposits in this institution exceed the amount of insurance provided on such deposits. The Company has not experienced any net losses on its deposits of cash and marketable securities.
The Company’s revenue and accounts receivable are spread across a large number of customers, primarily in the United States, and no customer accounts for more than 10% of total revenue or gross accounts receivable in any period presented.
Fair Value of Financial Instruments
Carrying amounts of certain of the Company’s financial instruments, including cash equivalents, accounts receivable, accounts payable, and accrued liabilities, approximate fair value due to their relatively short maturities and market interest rates, if applicable. The Company's marketable securities are classified as Level 1 or Level 2 of the fair value hierarchy as defined below. The carrying value of the Company’s long-term debt also approximates fair value based on management’s estimation that a current interest rate would not differ materially from the stated rate.
The Company discloses and recognizes the fair value of its assets and liabilities using a hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. 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 liability. As a basis for considering such assumptions, a three-tier value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows:
Level 1: Quoted prices (unadjusted) in active market that are accessible at measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.
Level 2: Observable prices that are based on inputs not quoted on active markets, but corroborated by market data.
Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.
Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and considers factors specific to the asset or liability.
Cash and Cash Equivalents
The Company considers all highly liquid investments with remaining maturities at the date of purchase of three months or less to be cash equivalents.
Marketable Securities
The Company's marketable securities primarily consist of investments in money market funds, U.S. treasury securities, U.S. agency bonds, corporate bonds and commercial paper. All of the Company's marketable securities are available-for-sale debt securities and are classified based on their maturities. Marketable securities with remaining maturities at the date of purchase of three months or less are classified as cash equivalents. Short term investments are securities that original or remaining maturity is greater than three months and not more than twelve months. Long-term investments are securities that original or remaining maturity is more than twelve months. All marketable securities are recorded at their estimated fair value. When the fair value of a security is below its amortized cost, the amortized cost will be reduced to its fair value if it is more likely than not that the Company will be required to sell the potentially impaired security before recovery of its amortized cost basis, or the Company has the intention to sell the security. If neither of these conditions are met, the Company determines whether the impairment is due to credit losses by comparing the present value of the expected cash flows of the security with its amortized cost basis. The amount of impairment recognized is limited to the excess of the amortized cost over the fair value of the security. An allowance for credit losses for the excess of amortized cost over the expected cash flows is recorded in other income, net in the consolidated statements of operations. Impairment losses that are not credit-related are included in accumulated other comprehensive income (loss) in stockholders’ equity.
Accounts Receivable and Allowance for Credit Losses
Trade accounts receivable are recorded at the invoiced amount, net of allowances for credit losses for any potential uncollectible amounts. The allowance for credit losses is based on our assessment of the collectability of accounts. Management regularly reviews the adequacy of the allowance for credit losses on a collective basis by considering the age of each outstanding invoice, each customer’s expected ability to pay and collection history, current market conditions, and reasonable and supportable forecasts of future economic conditions to determine whether the allowance is appropriate. Accounts receivable are written-off and charged against an allowance for credit losses when the Company has exhausted collection efforts without success.
The movement in the allowance for credit losses was as follows:
| Year ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| (in thousands) | ||
| Balance at beginning of year | $400 | $264 |
| Provision | 761 | 150 |
| Write-offs | (43) | (14) |
| Balance at end of year | $1,118 | $400 |
Inventory
Inventory is stated at lower of cost or net realizable value. The Company establishes the inventory basis by determining the cost based on standard costs approximating the purchase costs on a first-in, first-out basis. The excess and obsolete inventory is estimated based on future demand and market conditions. Inventory write-downs are charged to cost of goods sold.
Property and Equipment
Property and equipment are stated at cost less accumulated depreciation and amortization. All property and equipment is depreciated on a straight-line basis over the estimated useful lives of the assets, which are as follows:
| Computer and office equipment | 3 – 5 years |
|---|---|
| Instrument trays | 3 years |
| Machinery and equipment | 3 – 5 years |
| Furniture and fixtures | 7 years |
Construction in progress includes assets that have not yet been placed into service including the cost of individual components of an instrument tray. Once an instrument tray is placed into service, the Company transfers its carrying value into surgical equipment and instrument trays and begins depreciating the cost of the instrument tray over its useful life. Leasehold improvements are amortized over the lesser of their useful lives or the life of the lease. Upon the sale or retirement of these assets, the cost and related accumulated depreciation are removed from the consolidated balance sheet and the resulting gain or loss is recognized in the consolidated statement of operations. Maintenance and repairs are charged to operations as incurred.
Impairment of Long-Lived Assets
The Company reviews long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets (or asset group) may not be fully recoverable. Whenever events or changes in circumstances suggest that the carrying amount of long-lived assets may not be recoverable, the Company estimates the future cash flows expected to be generated by the assets (or asset group) from its use or eventual disposition. If the sum of the expected future cash flows is less than the carrying amount of those assets, the Company recognizes an impairment loss based on the excess of the carrying amount over the fair value of the assets. Significant management judgment is required in the grouping of long-lived assets and forecasts of future operating results that are used in the discounted cash flow method of valuation. For the years ended December 31, 2023 and 2022, the Company hasnot experienced impairment losses on its long-lived assets.
Leases
The Company determines if an arrangement is a lease at inception. The classification of leases is evaluated at commencement and, as necessary, at modification. Operating leases are included in operating lease right-of-use assets and operating lease liabilities on the consolidated balance sheets. The Company does not have any material finance leases in any of the periods presented.
Under Accounting Standards Update ("ASU") 2016-02, Leases Topic 842 ("Topic 842"), operating lease expense is recognized on a straight-line basis over the term of the lease. Variable lease payments are recognized as operating expenses in the period in which the obligation for those payments is incurred. Variable lease payments primarily include common area maintenance, utilities, real estate taxes and other operating costs that are passed on from the lessor in proportion to the space leased by the Company. The lease term represents the non-cancelable period of the lease. For certain leases, the Company has an option to extend the lease term. These renewal options are not considered in the remaining lease term unless it is reasonably certain that the Company will exercise such options.
The Company elected certain practical expedients under Topic 842 which are: (i) to not record leases with an initial term of twelve months or less on the balance sheet; (ii) to combine the lease and non-lease components in determining the lease liabilities and right-of-use assets, and (iii) to carry forward prior conclusions about lease identification and classification. The Company’s lease contracts do not provide an implicit borrowing rate; hence the Company determined the incremental borrowing rate based on information available at lease commencement to determine the present value of lease liability. The Company determines its incremental borrowing rate based on the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment. The Company uses its headquarters in the United States ("parent entity")’s incremental borrowing rates as the treasury operations are managed centrally by the parent entity.
Revenue Recognition
The Company’s revenue is derived from the sale of its products to medical groups and hospitals through its direct sales force and third-party sales agents and resellers throughout the United States and Europe. The Company receives payment for its implants consumed during the surgery and does not receive additional or separate consideration for the use of the instrument tray furnished by the Company for the physicians’s use. The Company identifies the instrument trays as a lease component and the implants as a non-lease component in its arrangements with its customers. The Company determines that the non-lease component is qualitatively predominant, and as such, elected the practical expedient to not separate the lease and non-lease components. Therefore, the overall arrangement is accounted for under Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers (“ASC 606”).
In accordance with ASC 606, the Company recognizes revenue when control is transferred to the customer, in an amount that reflects the consideration the Company expects to be entitled to in exchange for the goods or services. Under the revenue recognition standard, the Company applies the following five step approach: (1) identify the contract with a customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract, and (5) recognize revenue when a performance obligation is satisfied. As it relates to product sales where the Company's sales representative delivers the product at the point of implantation at the hospital or medical facilities, the Company continues to recognize the revenue upon completion of the procedure and authorization by the customer, net of rebates and price discounts. This represents the majority of the Company's consolidated revenue. The Company also generates a small portion of revenue from the sale of products through third-party sales agents and to certain hospital or medical facilities where the products are ordered in advance of a procedure. The performance obligation is the delivery of the products and therefore, revenue is recognized upon shipment to the customers, net of rebates and price discounts. The Company accounts for rebates and price discounts as a reduction to revenue, calculated based on the terms agreed to with the customer. Sales prices are specified in either the customer contract or agreed price list, which is executed prior to the transfer of control to the customer. For certain hospitals and medical facilities, the Company has agreements in place consists of either a master services agreement or an agreed price list, which defines the terms and conditions of the arrangement, including the pricing information, payment terms and pertinent aspects of the relationship between the parties. The Company also has agreements in place with its third-party sales agents, which include standard terms that do not allow for payment contingent on resale of the product, obtaining financing, or other terms that could impact the distributor’s payment obligation. The Company's standard payment terms are generally net 30 to 90 days.
Shipping and Handling Costs
Shipping and handling costs are treated as fulfillment costs, which are expensed as incurred and are included in cost of goods sold.
Costs to Obtain Customer Contracts
Sales commissions and related expenses are considered incremental and recoverable costs of acquiring customer contracts. The Company’s sales commissions paid to its sales representatives are generally based on the surgeries performed. The Company applied the practical expedient that permits an entity to expense the cost to obtain a contract as incurred when the expected amortization is one year or less. The period of benefit is concurrent with when the Company recognizes its revenue and as such, the Company recognizes sales commissions as expense when incurred.
Warranty
The Company has a warranty program that provides a purchaser a one-time replacement of any iFuse implant at no additional cost for a revision procedure within aone-year period following the original procedure and is accounted for as a warranty accrual. The Company also provides a purchaser with a one-time credit equal to the purchase price paid for use on future purchases for any revision procedure within theone-year period following an original procedure where an implant is not required. The warranty is not priced or sold separately and is intended to safeguard the customer against defects and it does not provide incremental service to the customer. As such, it is considered an assurance type warranty and is not accounted as a service type warranty, which could represent a separate performance obligation. The Company accounts for these one-time credits as sales reserves and is included in accrued liabilities and other in the consolidated balance sheets. Sales and warranty reserves from the warranty program were immaterial as of December 31, 2023 and 2022.
Research and Development
Research and development costs are charged to operations as incurred and consist of costs incurred by the Company for the development of the Company’s product which primarily include: (1) employee-related expenses, including salaries, benefits, travel and stock-based compensation expense; (2) external research and development expenses; and (3) other expenses, which include direct and allocated expenses for facilities and other costs.
Advertising Expenditures
The cost of advertising is expensed as incurred and is included under sales and marketing expense in the consolidated statements of operations. Advertising expenses were $1.1 million and $1.6 million for the years ended December 31, 2023 and 2022, respectively.
Loss Contingency
The Company is subject to various potential loss contingencies arising in the ordinary course of business. From time to time, the Company may be involved in certain proceedings, legal actions and claims. Such matters are subject to many uncertainties, and the outcomes of these matters are not within the Company's control and may not be known for prolonged periods of time. In some actions, the claimants may seek damages, as well as other relief, including injunctions which may prohibit the Company to engage in certain activities, which, if granted, could require significant expenditures and/or result in lost revenues. The Company records a liability in the consolidated financial statements when a loss is known or considered probable and the amount can be reasonably estimated. If the reasonable estimate of a known or probable loss is a range, and no amount within the range is a better estimate than any other, the minimum amount of the range is accrued. If a loss is reasonably possible but not known or probable, and can be reasonably estimated, the estimated loss or range of loss is disclosed. In most cases, significant judgment is required to estimate the amount and timing of a loss to be recorded.
The Company applies the fair value recognition provisions of stock-based compensation. Stock-based compensation expense is recognized over the requisite service period using the straight-line method and is based on the value of the portion of stock-based payment awards that is ultimately expected to vest. As such, the Company’s stock-based compensation is reduced for the estimated forfeitures at the date of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. The Company uses historical data to estimate pre-vesting forfeitures and record stock-based compensation expense only for those awards that are expected to vest. To the extent actual forfeitures differ from the estimates, the difference will be recorded as a cumulative adjustment in the period that the estimates are revised.
The Company estimates the grant date fair value of stock options using the Black-Scholes option valuation model. The model requires management to make a number of assumptions including expected volatility, expected term, risk-free interest rate and expected dividends. A number of these assumptions are subjective, and their determination generally require judgment.
Expected Term -The expected term represents the period that the share-based awards are expected to be outstanding. The Company uses the simplified method to determine the expected term as permitted by the guidance. The simplified method is calculated as the average of the time to vesting and the contractual life of the options.
Expected Volatility - The expected volatility is measured using the historical daily changes in the market price of the Company's common stock over a period consistent with the expected term.
Risk-Free Interest Rate -The risk-free interest rate is based on the U.S. Treasury zero coupon issued in effect at the time of grant for periods corresponding with the expected term of the option.
Dividend Yield -The Company has not paid any dividends and has no current plans to pay dividends on its common stock. As such, the Company uses expected dividend yield of zero.
The fair value of the restricted stock unit (“RSU”) grant is based on the market price of the Company’s common stock on the date of grant.
The Company grants restricted stock unit awards subject to market and service vesting conditions to certain executive officers. This type of grant consists of the right to receive shares of common stock, subject to achievement of time-based criteria and certain market-related performance goals over a specified period, as established by the Compensation Committee of the Company’s Board of Directors. For these awards that are subject to market-related performance, the fair value is determined based on the number of shares granted and a Monte Carlo valuation model, which incorporates the probability of the achievement of the market-related performance goals as part of the grant date fair value. If such performance goals are not ultimately met, the expense is not reversed. Stock-based compensation expense is recognized ratably over the requisite service period.
In the event the underlying terms of stock awards are modified on which stock-based compensation was granted, additional expense is recognized for any modification that increases the total fair value of the share-based payment arrangement at the modification date.
Income Taxes
The Company accounts for income taxes under the asset and liability method, whereby deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using the enacted tax rates in effect for the year in which the differences are expected to affect taxable income. A valuation allowance is established when necessary to reduce deferred tax assets to the amounts expected to be realized.
The Company recognizes uncertain tax positions when it meets a more-likely-than-not threshold. The Company recognizes potential accrued interest and penalties related to unrecognized tax benefits as income tax expense.
Net Loss per Share of Common Stock
Basic net loss per common share is calculated by dividing the net loss by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and potentially dilutive securities outstanding for the period. For purposes of the diluted net loss per share calculation, common stock options, restricted stock units, ESPP purchase rights and warrants are considered to be potentially dilutive securities. Because the Company has reported a net loss in all periods presented, common stock options, restricted stock units, ESPP purchase rights and warrants are anti-dilutive and therefore diluted net loss per common share is the same as basic net loss per common share for those periods.
Comprehensive Loss
Comprehensive loss represents changes in the stockholders’ equity except those resulting from distributions to stockholders. The Company’s unrealized foreign currency translation income (losses) and unrealized gains (losses) on marketable securities represent the two components of other comprehensive income that are excluded from the reported net loss for each of the reporting periods and has been presented in the consolidated statements of operations and comprehensive loss.
Warrants
The Company accounts for warrants for shares of common stock as equity in accordance with the accounting guidance for derivatives. The accounting guidance provides a scope exception from classifying and measuring as a financial liability a contract that would otherwise meet the definition of a derivative if the contract is both (i) indexed to the entity’s own stock and (ii) classified in the stockholders’ equity section of the consolidated balance sheet. The Company determined that the warrants for shares of common stock issued in connection with its prior debt arrangements are required to be classified in equity. Warrants classified as equity are recorded as additional paid-in capital on the consolidated balance sheet and no further adjustments to their valuation are made.
Recently Issued Accounting Standards Not Yet Adopted
In October 2023, the Financial Accounting Standards Board ("FASB") issued ASU 2023-06, Disclosure Agreements - Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative ("ASU 2023-06"). This amendment will impact various disclosure areas, including the statement of cash flows, accounting changes and error corrections, earnings per share, debt, equity, derivatives, and transfers of financial assets. The amendments in this ASU 2023-06 will be effective on the date the related disclosures are removed from Regulation S-X or Regulation S-K by the SEC, and will no longer be effective if the SEC has not removed the applicable disclosure requirement by June 30, 2027. Early adoption is prohibited. The Company is currently evaluating the impacts of the amendment on its disclosures.
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. ASU 2023-07 requires companies with a single reportable segment to provide all existing segment disclosures, as well as requires incremental segment information to be disclosed. The guidance is effective for fiscal years beginning after December 15, 2023 on a retrospective basis, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company is currently evaluating the guidance to determine the impact on its disclosures.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures ("ASU 2023-09"). ASU 2023-09 requires public business entities to disclose additional information in specified categories with respect to the reconciliation of the effective tax rate to the statutory rate (the rate reconciliation) for federal, state, and foreign income taxes. It also requires greater detail about individual reconciling items in the rate reconciliation to the extent the impact of those items exceeds a specified threshold. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, and for interim periods for fiscal years beginning after December 15, 2025. The Company is currently evaluating the impacts of ASU 2023-09 on its disclosures.
- Marketable Securities
All of the Company's marketable securities were available-for-sale debt securities and were classified based on their maturities. Marketable securities with remaining maturities at the date of purchase of three months or less are classified as cash equivalents. Short-term investments are securities that original maturity or remaining maturity is greater than three months and not more than twelve months. Long-term investments are securities for which the original maturity or remaining maturity is greater than twelve months.
The table below summarizes the marketable securities:
| December 31, 2023 | ||||
|---|---|---|---|---|
| Amortized Cost | Unrealized Gains | Unrealized Losses | Aggregate Fair Value | |
| (in thousands) | ||||
| Money market funds | $23,331 | $— | $— | $23,331 |
| Cash equivalents | 23,331 | — | — | 23,331 |
| U.S. treasury securities | 129,695 | 67 | — | 129,762 |
| U.S. agency bonds | 2,988 | — | (2) | 2,986 |
| Short-term investments | 132,683 | 67 | (2) | 132,748 |
| Total marketable securities | $156,014 | $67 | $(2) | $156,079 |
| December 31, 2022 | ||||
|---|---|---|---|---|
| Amortized Cost | Unrealized Gains | Unrealized Losses | Aggregate Fair Value | |
| (in thousands) | ||||
| Money market funds | $8,002 | $— | $— | $8,002 |
| Cash equivalents | 8,002 | — | — | 8,002 |
| U.S. treasury securities | 48,636 | 4 | (105) | 48,535 |
| U.S. agency bonds | 2,918 | 3 | — | 2,921 |
| Corporate bonds | 2,914 | — | (3) | 2,911 |
| Commercial paper | 22,206 | — | — | 22,206 |
| Short-term investments | 76,674 | 7 | (108) | 76,573 |
| Total marketable securities | $84,676 | $7 | $(108) | $84,575 |
The amortized cost of the Company's available-for-sale securities approximates their fair value. Unrealized losses are generally due to interest rate fluctuations, as opposed to credit quality. However, the Company reviews individual securities that are in an unrealized loss position in order to evaluate whether or not they have experienced or are expected to experience credit losses. As of December 31, 2023 and 2022, unrealized gains and losses from the investments were not material and were not the result of a decline in credit quality. As a result, the Company didnot recognize any credit losses related to its investments and that all unrealized gains and losses on available-for-sale securities are recorded in accumulated other comprehensive income (loss) on the consolidated balance sheets during the years ended December 31, 2023 and 2022.
The Company elected to present accrued interest receivable separately from short-term and long-term investments on its consolidated balance sheets. Accrued interest receivable was $0.2 millionas of December 31, 2023, and was recorded inprepaid expenses and other current assets. The Company also elected to exclude accrued interest receivable from the estimation of expected credit losses on its marketable securities and reverse accrued interest receivable through interest income (expense) when amounts are determined to be uncollectible. The Company didnot write off any accrued interest receivable during the years ended December 31, 2023 and 2022.
- Fair Value Measurement
Carrying amounts of certain of the Company’s financial instruments, including cash equivalents, accounts receivable, accounts payable and accrued liabilities, approximate fair value due to their relatively short maturities and market interest rates, if applicable. The carrying value of the Company’s long-term debt also approximates fair value based on management’s estimation that a current interest rate would not differ materially from the stated rate. There were no other financial assets and liabilities that requires fair value hierarchy measurements and disclosures for the periods presented.
The table below summarizes the fair value of the Company’s marketable securities measured at fair value on a recurring basis based on the three-tier fair value hierarchy:
| December 31, 2023 | ||||
|---|---|---|---|---|
| Level 1 | Level 2 | Level 3 | Total | |
| (in thousands) | ||||
| Marketable securities | ||||
| Money market funds | $23,331 | $— | $— | $23,331 |
| U.S. treasury securities | 129,762 | — | — | 129,762 |
| U.S. agency bonds | — | 2,986 | — | 2,986 |
| Total marketable securities | $153,093 | $2,986 | $— | $156,079 |
| December 31, 2022 | ||||
| Level 1 | Level 2 | Level 3 | Total | |
| (in thousands) | ||||
| Marketable securities | ||||
| Money market funds | $8,002 | $— | $— | $8,002 |
| U.S. treasury securities | 48,535 | — | — | 48,535 |
| U.S. agency bonds | — | 2,921 | — | 2,921 |
| Corporate bonds | — | 2,911 | — | 2,911 |
| Commercial paper | — | 22,206 | — | 22,206 |
| Total marketable securities | $56,537 | $28,038 | $— | $84,575 |
- Balance Sheet Components
Inventory
As of December 31, 2023, inventory consisted of finished goods of $18.8 million and work-in-progress and components of $1.4 million. As of December 31, 2022, inventory consisted of finished goods of $15.6 million and work-in-progress and components of $1.7 million.
Property and Equipment, net:
| December 31, 2023 | December 31, 2022 | |
|---|---|---|
| (in thousands) | ||
| Instrument trays | $18,205 | $13,092 |
| Machinery and equipment | 3,067 | 1,828 |
| Construction in progress | 3,856 | 7,854 |
| Computer and office equipment | 1,856 | 976 |
| Leasehold improvements | 3,873 | 1,631 |
| Furniture and fixtures | 389 | 390 |
| 31,246 | 25,771 | |
| Less: Accumulated depreciation and amortization | (15,246) | (10,207) |
| $16,000 | $15,564 | |
As of December 31, 2023, construction in progress pertains to cost of individual components of a custom instrument set used for surgical placement of the Company's products that have not yet been placed into service of $3.5 million and software costs of $0.4 million. Depreciation expense was $5.4 million and $3.4 million for the years ended December 31, 2023 and 2022, respectively.
Accrued Liabilities and Other:
| December 31, 2023 | December 31, 2022 | |
|---|---|---|
| (in thousands) | ||
| Accrued compensation and related expenses | $13,464 | $11,365 |
| Accrued royalty | 1,360 | 818 |
| Accrued professional services | 929 | 355 |
| Others | 1,699 | 973 |
| $17,452 | $13,511 | |
- Commitments and Contingencies
Operating Leases
The Company has a non-cancelable operating lease for an office building space, located in Santa Clara, California which expires in May 2025 and a building used for research and development and warehouse space in Santa Clara, California which expires in October 2026. The Company also has a non-cancelable operating lease for its office building spaces in Gallarate, Italy which expires in August 2027.
The Company also leases vehicles under operating lease arrangements for certain of its personnel in Europe which expire at various times throughout 2022 to 2026.
Supplemental information related to lease expense and valuation of the lease assets and lease liabilities are as follows:
| December 31, 2023 | December 31, 2022 | |
|---|---|---|
| (in thousands) | ||
| Operating lease expense | $1,552 | $1,599 |
| Variable lease expense | 465 | 461 |
| Total lease expense | $2,017 | $2,060 |
| Cash paid for amounts included in the measurement of operating lease liabilities | $1,632 | $1,600 |
| Leased assets obtained in exchange for new operating lease liabilities | $143 | $127 |
| Weighted average remaining lease term (in years) | 2.20 | 3.05 |
| Weighted average discount rate | 5.87% | 5.77% |
Future minimum lease payments under non-cancelable operating leases as of December 31, 2023 was as follows:
| Year Ending December 31, | (in thousands) |
|---|---|
| 2024 | $1,543 |
| 2025 | 1,019 |
| 2026 | 547 |
| 2027 | 9 |
| 2028 | — |
| Thereafter | — |
| Total operating lease payments | $3,118 |
| Less: imputed interest | (191) |
| Total operating lease liabilities | $2,927 |
As of December 31, 2023, the Company had no operating lease liabilities that had not commenced.
Purchase Commitments and Obligations
The Company has certain purchase commitments related to its inventory management with certain manufacturing suppliers wherein the Company is required to purchase the amounts forecasted in a blanket purchase order. The contractual obligations represent future cash commitments and liabilities under agreements with third parties and exclude orders for goods and services entered into in the normal course of business that are not enforceable or legally binding. These outstanding commitments amounted to $0.4 million and $0.8 million as of December 31, 2023 and 2022, respectively.
Indemnification
The Company enters into standard indemnification arrangements in the ordinary course of business. Pursuant to these arrangements, the Company indemnifies, holds harmless, and agrees to reimburse the indemnified parties for losses suffered or incurred by the indemnified party, in connection with any trade secret, copyright, patent or other intellectual property infringement claim by any third-party with respect to the Company’s technology. The term of these indemnification agreements is generally perpetual. The maximum potential amount of future payments the Company could be required to make under these agreements is not determinable because it involves claims that may be made against the Company in the future, but have not yet been made.
The Company has entered into indemnification agreements with its directors and officers that may require the Company to indemnify its directors and officers against liabilities that may arise by reason of their status or service as directors or officers, other than liabilities arising from willful misconduct of the individual.
The Company hasnot incurred costs to defend lawsuits or settle claims related to these indemnification agreements. No liability associated with such indemnifications has been recorded to date.
Legal Contingencies
From time to time, the Company may become involved in legal proceedings arising in the ordinary course of its business. The Company is not presently a party to any material legal proceedings that, if determined adversely to the Company, would have a material adverse effect on the Company.
- Borrowings
Term Loan
The following table summarizes the outstanding borrowings from the term loan as of the periods presented:
| December 31, 2023 | December 31, 2022 | |
|---|---|---|
| (in thousands) | ||
| Principal outstanding and final fee | $36,720 | $35,700 |
| Less: Unamortized debt issuance costs | (81) | (73) |
| Unaccreted value of final fee | (574) | (456) |
| Outstanding debt, net of debt issuance costs and unaccreted value of final fee | $36,065 | $35,171 |
| Classified as: | ||
| Long-term borrowings | $36,065 | $35,171 |
The outstanding debt is related to a term loan pursuant to the Loan and Security Agreement dated August 12, 2021 entered into by the Company with Silicon Valley Bank (“SVB”). Pursuant the agreement, SVB provided a term loan in the aggregate principal amount of $35.0 million to the Company (the “Original Term Loan”).
On January 6, 2023, the Company entered into a First Amendment to Loan and Security Agreement (the “Amendment”) with SVB, which amended the Company's Original Term Loan pursuant to which the Company had a new term loan facility in an aggregate principal amount of $35.0 million (the “Original Loan Agreement” and with the Amendment, collectively the “Amended Loan Agreement”). Upon entry into the Amended Loan Agreement, the Company borrowed $36.0 million pursuant to a term loan (the "Term Loan"), which was substantially used to repay in full the $35.0 million term loan facility outstanding under the Original Loan Agreement and secured a revolving credit facility in an aggregate principal amount of up to $15.0 million (the “Revolving Line”). On March 14, 2023 all of SVB’s assets and liabilities, including all of SVB’s rights as the lender pursuant to the Amended Loan Agreement, were assigned to Silicon Valley Bridge Bank. On March 27, 2023, all of Silicon Valley Bridge Bank’s assets and liabilities were assigned and assumed by First-Citizens Bank & Trust Company (“First-Citizens”). The Amended Loan Agreement also includes an uncommitted accordion term loan in an aggregate principal amount of up to $15.0 million, which accordion may be approved by First-Citizens solely in its discretion, upon the Company’s request. The Term Loan matures on December 1, 2027 (the “Term Loan Maturity Date”). Interest on the Term Loan will be payable monthly at a floating annual rate set at the greater of the prime rate as published in the Wall Street Journal plus 0.5% or 6.75%. Commencing on July 1, 2025, the Company will be required to make monthly principal Term Loan amortization payments. A final fee payment of 2% of the original principal amount of the Term Loan is due upon the earlier of the Term Loan Maturity Date, termination, acceleration by First-Citizens following an event of default, or prepayment of the Term Loan. The Company may elect to prepay the Term Loan in whole prior to the Term Loan Maturity Date subject to a prepayment fee equal to 2% of the principal amount of the Term Loan prepaid at such time. No prepayment fee would be due if the Term Loan is refinanced by First-Citizens. Pursuant to the terms of the Amended Loan Agreement, revolving loans may be borrowed, repaid and reborrowed until the maturity date, which will be July 6, 2025 (the “Revolving Line Maturity Date”). Borrowings under the Revolving Line are based on 80% of eligible domestic accounts receivable borrowing base. Interest on the outstanding balance of the Revolving Line will be payable monthly at a floating annual rate set at the greater of the prime rate as published in the Wall Street Journal or 6.25%. Interest on borrowings is due monthly and any principal balance is due on the Revolving Line Maturity Date, provided that when Revolving Line Advances are outstanding, in the event the Company does not maintain an adjusted quick ratio of at least 1.5 to 1.0, then falling below such threshold will allow First-Citizens to apply accounts receivable collections to outstanding Revolving Line borrowings. The Company will pay a total commitment fee of $187,500 on account of the Revolving Line payable in installments, but fully earned at close. The Company will also be required to pay a fee of $150,000 if it terminates the Amended Loan Agreement or Revolving Line prior to Revolving Line Maturity Date, or if First-Citizens terminates the Loan Agreement or the Revolving Line following an event of default. No termination fee would be due if the Revolving Line is replaced with a new facility with First-Citizens. No amounts were outstanding under the Revolving Line as of December 31, 2023.
The Company accounted for the Amended Loan Agreement as a debt modification. Accordingly, the remaining unamortized debt issuance costs related to the Original Loan Agreement together with any lender fees incurred in connection with the entry of the
Amended Loan Agreement are amortized to interest expense using the straight-line method over the new term of the loan through December 2027.
The effective interest rate related to the First-Citizens Term Loan for the the years ended December 31, 2023 was 9.0%. The effective interest rate related to the Original Term Loan was 7.8% for the year ended December 31, 2022.
The table below summarizes the future principal and final fee payments under the Term Loan as of December 31, 2023:
| Year ending December 31, | (in thousands) |
|---|---|
| 2024 | $— |
| 2025 | 8,400 |
| 2026 | 14,400 |
| 2027 | 13,920 |
| 2028 | — |
| Total principal and final fee payments | $36,720 |
The Term Loan includes affirmative and negative covenants applicable to the Company and certain of its foreign subsidiaries. The affirmative covenants include, among others, covenants requiring the Company to maintain its legal existence and governmental compliance, deliver certain financial reports, and maintain insurance coverage. The negative covenants include, among others, restrictions regarding transferring collateral, pledging the Company's intellectual property to other parties, engaging in mergers or acquisitions, paying dividends or making other distributions, incurring indebtedness, transacting with affiliates, and entering into certain investments, in each case subject to certain exceptions. As of December 31, 2023, the Company was in compliance with all debt covenants.
In January 2023, the Company's outstanding amount under the Original Term Loan was refinanced on a long-term basis and was accordingly classified as term note, non-current as of December 31, 2022.
- Warrants
During the three months ended June 30, 2023, a warrant holder exercised warrants, and the Company issued 22,603 net shares of common stock through a cashless exercise of the warrants in accordance with the conversion terms. The table below summarizes common stock warrants issued and outstanding at December 31, 2023 and 2022:
| Date · Outstanding Balance at December 31, 2022 · Price per Share · Warrants Issued · Warrant Exercised · Warrant Expired · Outstanding Balance at December 31, 2023 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Issuance | Expiration | |||||||||||
| 3/1/2017 | 3/1/2027 | 1,388 | $5.94 | — | — | — | 1,388 | |||||
| 7/22/2013 | 7/22/2023 | 32,983 | $9.10 | — | (32,983) | — | — | |||||
| 11/26/2014 | 11/26/2024 | 6,680 | $16.47 | — | — | — | 6,680 | |||||
| 10/20/2015 | 10/20/2025 | 41,650 | $16.47 | — | — | — | 41,650 | |||||
| 11/9/2015 | 11/9/2025 | 25,709 | $16.47 | — | — | — | 25,709 | |||||
| 12/22/2016 | 12/22/2026 | 9,712 | $10.03 | — | — | — | 9,712 | |||||
| 118,122 | — | (32,983) | — | 85,139 | ||||||||
- Common and Preferred Stock
The Company's certificate of incorporation as amended and restated in October 2018, authorizes the Company to issue 100,000,000 shares of common stock and 5,000,000 shares of preferred stock, each having a par value of $0.0001. Common stock issued and outstanding as of December 31, 2023 and 2022 were 40,693,299 shares and 34,731,577 shares, respectively. As of December 31, 2023 and 2022, there wasno preferred stock issued and outstanding.
The holders of common stock are entitled to receive dividends whenever funds are legally available, as, when, and if declared by the Board of Directors. There have beenno dividends declared to date.
- Stock-Based Compensation
2008 Stock Option Plan and 2018 Equity Incentive Plan
In April 2008, the Company adopted the 2008 Stock Option Plan (the “2008 SOP”), as amended, under which the Board of Directors may issue incentive and non-qualified stock options to employees, directors and consultants. In October 2018, the Company adopted the 2018 Equity Incentive Plan (the “2018 EIP”), which serves as the successor to the 2008 SOP, under which the Board of Directors may issue incentive and non-qualified stock options, RSUs and PSUs to employees, directors and consultants. No new options have been granted under the 2008 SOP since August 2018. Outstanding options under the 2008 SOP continue to be subject to the terms and conditions of that plan.
The number of shares of common stock reserved for issuance under the 2018 EIP will automatically increase on January 1 of each year, beginning January 1, 2019, and continuing through and including January 1, 2028, by 5% of the total number of shares of the Company's capital stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares determined by the Company's Board of Directors. As of December 31, 2023, a total of 4,454,432 shares of common stock are available for future grants under the 2018 EIP. On January 1, 2024, the total number of shares of common stock reserved for issuance under the 2018 EIP automatically increased by 2,034,664 shares.
The Board of Directors has the authority to determine to whom options will be granted, the number of shares, the term and the exercise price. If an individual owns stock representing more than 10% of the outstanding shares, the price of each share shall be at least 110% of the fair market value, as determined by the Board of Directors. The exercise price of an incentive stock option and a non-qualified stock option shall not be less than 100% and 85%, respectively, of the fair market value on the date of grant.
Options granted have a term of 10 years, except, options granted to individuals holding more than 10% of the outstanding shares have a term offive years. Options generally vest over afour-year period. RSUs granted under the 2018 EIP generally vest overtwo tofour years based upon continued services and are settled at vesting in shares of the Company's common stock.
Stock Options
The following table summarizes stock option activity for the years ended December 31, 2023 and 2022:
| Options Outstanding | ||||
|---|---|---|---|---|
| Number of Shares | Weighted-Average Exercise Price | Weighted-Average Contractual Remaining Life (Years) | Aggregate Intrinsic Value (in thousands) | |
| Outstanding as of December 31, 2021 | 2,009,513 | $8.73 | ||
| Exercised | (80,571) | $4.70 | ||
| Canceled and forfeited | (25,601) | $15.05 | ||
| Outstanding as of December 31, 2022 | 1,903,341 | $8.82 | ||
| Exercised | (698,627) | $6.28 | ||
| Canceled and forfeited | (16,006) | $21.22 | ||
| Outstanding as of December 31, 2023 | 1,188,708 | $10.14 | 3.51 | $13,197 |
| Options vested and exercisable as of December 31, 2023 | 1,188,708 | $10.14 | 3.51 | $13,197 |
| Options vested and expected to vest as of December 31, 2023 | 1,188,708 | $10.14 | 3.51 | $13,197 |
The aggregate intrinsic value of options exercised during the years ended December 31, 2023 and 2022 amounted to $11.7 million and $1.0 million, respectively, representing the difference between the fair value of the Company's common stock at the date of exercise and the exercise price paid. The aggregate intrinsic values of options outstanding, options vested and exercisable, and options vested and expected to vest as of December 31, 2023 represents the difference between the exercise price and the closing price of the Company’s common stock on the last trading day of the year.
Outstanding options and exercisable options information by range of exercise prices as of December 31, 2023 was as follows:
| Exercise Price · Options Outstanding · Options Vested and Exercisable | |||||||
|---|---|---|---|---|---|---|---|
| Number of Shares · Average Remaining Contractual Life (Years) · Weighted- Average Exercise Price · Number of Shares · Weighted- Average Exercise Price | |||||||
| $3.24 | - | $4.41 | 375,262 | 1.91 | $4.14 | 375,262 | $4.14 |
| $4.42 | - | $5.31 | 300,673 | 3.31 | $4.68 | 300,673 | $4.68 |
| $5.32 | - | $18.10 | 198,341 | 4.41 | $11.28 | 198,341 | $11.28 |
| $18.11 | - | $20.51 | 18,838 | 5.08 | $18.71 | 18,838 | $18.71 |
| $20.52 | - | $22.00 | 295,594 | 5.04 | $22.00 | 295,594 | $22.00 |
| 1,188,708 | 3.51 | $10.14 | 1,188,708 | $10.14 | |||
There wereno stock options granted during the years ended December 31, 2023 and 2022.
As of December 31, 2023, there isno unrecognized compensation cost related to stock options.
Restricted Stock Units
Restricted stock units (“RSUs”) are share awards that entitle the holder to receive freely tradable shares of the Company’s common stock upon vesting. RSUs generally vest overtwo tofour years based upon continued services and are settled at vesting in shares of the Company's common stock. The grant date fair value of the RSUs is equal to the closing price of the Company’s common stock on the grant date.
The Company has granted performance-based restricted stock unit awards subject to market and service vesting conditions to certain executive officers under SI-BONE's 2018 Equity Incentive Plan (“PSUs”). The shares subject to the PSUs vest over athree-year performance period. The actual number of PSUs that will vest in each measurement period will be determined by the Compensation Committee based on the Company’s total shareholder return (“TSR”) relative to the TSR of the Median Peer Companies (as defined in the award agreement). The grant date fair value of each stock award with a market condition was determined using the Monte Carlo valuation model. The table below summ arizes the assumptions used to estimate the grant date fair value of the PSUs granted:
| Year Ended December 31, | ||||||
|---|---|---|---|---|---|---|
| 2023 · 2022 | ||||||
| Expected volatility of common stock | 58.0% | to | 73.0% | 48.9% | to | 58.7% |
| Expected volatility of peer companies | 33.0% | to | 141.0% | 24.2% | to | 152.5% |
| Correlation coefficient of peer companies | (0.15) | to | 1.00 | (0.13) | to | 1.00 |
| Risk-free interest rate | 3.9% | to | 5.0% | 0.4% | to | 1.2% |
| Dividend yield | —% | to | 1.3% | —% | to | 1.0% |
The following table summarizes RSU and PSU activity for the years ended December 31, 2023 and 2022:
| RSUs | PSUs | |||
|---|---|---|---|---|
| Number of Shares | Weighted- Average Grant Date Fair Value | Number of Shares | Weighted- Average Grant Date Fair Value | |
| Outstanding as of December 31, 2021 | 1,566,522 | $25.17 | — | — |
| Granted | 1,264,835 | $20.66 | 155,596 | $19.50 |
| Vested | (806,204) | $24.03 | — | — |
| Canceled and forfeited | (230,225) | $23.46 | — | — |
| Outstanding as of December 31, 2022 | 1,794,928 | $22.72 | 155,596 | $19.50 |
| Granted | 1,235,471 | $16.92 | 255,458 | $12.33 |
| Vested | (967,145) | $21.01 | (25,932) | $19.50 |
| Canceled and forfeited | (163,464) | $21.41 | — | — |
| Outstanding as of December 31, 2023 | 1,899,790 | $19.93 | 385,122 | $14.74 |
As of December 31, 2023, the unrecognized compensation cost related to the RSUs was $30.2 million, which is expected to be recognized over a period of approximately 2.3 years. As of December 31, 2023, the unrecognized compensation cost related to the PSUs was $2.2 million, which is expected to be recognized over a period of approximately 1.8 years.
Employee Stock Purchase Plan
The Company’s 2018 Employee Stock Purchase Plan (the “ESPP”) allows eligible employees to purchase shares of the Company's common stock through payroll deductions at the price equal to 85% of the lesser of the fair market value of the stock as of the first date or the ending date of eachsix month offering period. The offering period generally commences in May and November. On March 26, 2020, the Company's Compensation Committee approved the amendment of the terms of future offerings under the ESPP which, among other things, increased the maximum number of shares that may be purchased on any single purchase date and provided for automatic enrollment in a new offering.
As of December 31, 2023, a total of 1,218,576 shares of common stock are available for future grants under the ESPP. On January 1, 2024, the total number of shares of common stock reserved for issuance under the ESPP Plan increased by 406,932 shares.
The fair value of the ESPP shares is estimated using the Black-Scholes option pricing model, which is being amortized over the requisite service period. The Company issued 178,918 shares and 170,717 shares under the ESPP during the years ended December 31, 2023 and 2022, respectively, representing $2.2 million and $1.8 million in employee contributions. For each of the years ended December 31, 2023 and 2022, total accumulated ESPP related employee payroll deductions amounted to $0.4 million and $0.3 million, respectively, which were included within accrued compensation and related expenses in the consolidated balance sheets. For the years ended December 31, 2023 and 2022, the Company recognized $1.0 million and $0.7 million, respectively, of stock-based compensation expense related to ESPP. As of December 31, 2023, the unrecognized compensation cost for the ESPP was $0.4 million.
The Company estimated the fair value of ESPP purchase rights during the offering period using a Black-Scholes option pricing model with the following assumptions:
| Year Ended December 31, | ||||||
|---|---|---|---|---|---|---|
| 2023 · 2022 | ||||||
| Expected term (years) | 0.5 | 0.5 | ||||
| Expected volatility | 41.9% | to | 54.4% | 49.5% | to | 62.1% |
| Risk-free interest rate | 5.26% | to | 5.38% | 0.07% | to | 1.54% |
| Dividend yield | —% | —% | ||||
The following table sets forth stock-based compensation expense recognized for the periods presented:
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| (in thousands) | ||
| Cost of goods sold | $672 | $484 |
| Sales and marketing | 10,931 | 11,006 |
| Research and development | 2,933 | 2,637 |
| General and administrative | 9,521 | 8,934 |
| $24,057 | $23,061 | |
- Employee Benefit Plan
The Company sponsors a 401(k) plan covering all employees. Contributions made by the Company are discretionary and are determined annually by the Board of Directors. Effective January 1, 2019, the Company made a discretionary matching contribution equal to dollar for dollar employee contribution, up to 3% eligible compensation of the employee, with a maximum annual contribution from the Company ofone thousand dollars per employee. Further, in order for an employee to receive the matching contribution, the employee must be at least 21 years old, work at least 1,000 hours per year, and must be employed by the Company at the beginning through the end of the year.
- Net Loss Per Share of Common Stock
The following table summarizes the computation of basic and diluted net loss per share:
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| (in thousands, except share and per share data) | ||
| Net loss | $(43,336) | $(61,256) |
| Weighted-average shares used to compute basic and diluted net loss per share | 38,427,419 | 34,201,824 |
| Net loss per share, basic and diluted | $(1.13) | $(1.79) |
Because the Company has reported a net loss in all periods presented, outstanding stock options, restricted stock units, ESPP purchase rights and common stock warrants are anti-dilutive and therefore diluted net loss per common share is the same as basic net loss per common share for the periods presented. The following anti-dilutive common stock equivalents were excluded from the computation of diluted net loss per share for the periods presented:
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Stock options | 1,188,708 | 1,903,341 |
| Restricted stock units | 2,284,912 | 1,950,524 |
| ESPP purchase rights | 102,172 | 134,226 |
| Common stock warrants | 85,139 | 118,122 |
| 3,660,931 | 4,106,213 | |
- Income Taxes
The components of the Company’s loss before income taxes are as follows:
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| (in thousands) | ||
| Domestic | $(43,491) | $(61,396) |
| Foreign | 155 | 140 |
| Loss before income taxes | $(43,336) | $(61,256) |
There wasno provision for income taxes recorded for the years ended December 31, 2023 and 2022. The Company continues to maintain a full valuation allowance against its net deferred tax assets due to the uncertainty surrounding realization of such assets. The Company periodically evaluates the realizability of its net deferred tax assets based on the expected realization and is dependent on the Company's ability to generate sufficient future taxable income during periods prior to the expiration of tax attributes to fully utilize these assets.
The components of deferred income taxes are as follows:
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| (in thousands) | ||
| Federal | $10,606 | $13,085 |
| State | 1,856 | 2,997 |
| Foreign | (28) | (92) |
| Total deferred income taxes | 12,434 | 15,990 |
| Change in deferred tax valuation allowance | (12,434) | (15,990) |
| Net deferred income tax | $— | $— |
Income tax expense differs from the amount computed by applying the statutory federal income tax rate due to the following:
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Tax at statutory federal rate | (21.0)% | (21.0)% |
| State tax, net of federal benefit | (4.3)% | (4.9)% |
| Tax credits | (1.3)% | (0.7)% |
| Change in deferred tax valuation allowance | 28.7% | 26.1% |
| Stock compensation | (2.8)% | 0.3% |
| Foreign rate differences | (2.1)% | 0.1% |
| Other | 2.8% | 0.1% |
| Total income tax expense | —% | —% |
The tax effects of temporary differences and carryforwards that give rise to significant portions of the deferred tax assets are presented below:
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| (in thousands) | ||
| Net operating loss carryforwards | $85,173 | $77,057 |
| Research and development credits | 5,342 | 4,464 |
| Accruals and reserves | 3,698 | 2,616 |
| Interest limitation | 4,378 | 4,447 |
| Depreciation and amortization | 474 | 263 |
| Stock compensation | 3,474 | 3,378 |
| Operating lease liabilities | 735 | 1,079 |
| Capitalized research and development | 4,614 | 2,486 |
| Total deferred tax assets | 107,888 | 95,790 |
| Operating lease right-of-use assets | (678) | (1,014) |
| Total deferred tax liabilities | (678) | (1,014) |
| Less: Valuation allowance | (107,210) | (94,776) |
| Total deferred tax asset, net of valuation allowance | $— | $— |
The following table summarizes changes in the valuation allowance for the years ended December 31, 2023 and 2022:
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| (in thousands) | ||
| Beginning balance | $94,776 | $78,786 |
| Net changes during the period | 12,434 | 15,990 |
| Ending balance | $107,210 | $94,776 |
As of December 31, 2023, the Company had net operating loss (“NOL”) carryforwards of approximately $331.6 million and $259.6 million available to reduce future taxable income, if any, for federal and state income tax purposes, respectively. If not utilized, the Company’s federal NOL carryforward begins to expire in 2030, and the state NOL carryforward beganto expire in 2023.
As of December 31, 2023, the Company had credit carryforwards of approximately $4.6 million and $3.8 million available to reduce future taxable income, if any, for both federal and state income tax purposes, respectively. The federal credits begin to expire in 2029, and the state credits have no expiration date.
The Company updated its Section 382 ownership change analysis through December 31, 2020 and determined that the last ownership change was in February 2020 due to the follow-offering. The analysis concluded that no additional NOL carryforwards will expire due to the Section 382 limitation from the ownership change for both federal and state tax purposes. The Company maintains the reduction of $1.4 million of its NOL carryforwards from the previous ownership change. The Company has reviewed changes in the outstanding number of shares and equity transactions for the period January 1, 2021 through December 31, 2023 to determine if an additional ownership change occurred for Section 382 purposes. The Company reasonably believes no additional ownership change occurred in the current year, however, noted there has been a material increase to the equity shift. The Company will continually assess the need to update its Section 382 ownership change analysis. An ownership change in the future could materially limit the Company’s ability to utilize its NOL carryforwards and other tax attributes.
Under an Organization for Economic Co-operation and Development Inclusive Framework, countries that agreed to enact a two-pillar solution aim to address the challenges arising from the digitalization of the world economy (Pillar Two). Pillar Two sets out a global minimum Effective Tax Rate (ETR) rules to ensure that large multinational businesses with consolidated revenue over €750 million are subject to a minimum ETR of 15% on income arising in low-tax jurisdictions. Rules under Pillar Two are expected to be enacted beginning January 1, 2024. The Company will continue to monitor the impact of Pillar Two; however, the Pillar Two is currently not applicable as the Company does not meet the threshold of having consolidated revenue over €750 million.
The Company accounts for the uncertainty in income taxes by utilizing a comprehensive model for the recognition, measurement, presentation and disclosure in financial statements of any uncertain tax positions that have been taken or are expected to be taken on an income tax return. The changes in the Company’s uncertain income tax positions for the years ended December 31, 2023 and 2022 consisted of the following:
| Year ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| (in thousands) | ||
| Balance at beginning of the year | $2,944 | $2,655 |
| Increases related to tax positions taken prior to current year | (726) | $(12) |
| Increases related to current year's tax positions | 411 | 301 |
| Balance at end of the year | $2,629 | $2,944 |
The Company has elected to recognize interest and penalties related to uncertain tax positions as a component of income tax expense. The Company hasno accrued interest related to unrecognized tax benefits as of December 31, 2023 and 2022. None of the Company’s unrecognized tax benefits that, if recognized, would affect its effective tax rates for the years ended December 31, 2023 and 2022. The Company does not anticipate the total amounts of unrecognized tax benefits will significantly increase or decrease in the next 12 months.
The Company currently has no federal, state or foreign tax examinations in progress nor has it had any federal or state examinations since inception. As a result of the Company’s net operating loss carry forwards, all of its tax years are subject to federal and state tax examinations.
- Related Party Transactions
On February 24, 2020, the Company entered into a joint development agreement (the “Development Agreement”) with SeaSpine Orthopedics Corporation (“SeaSpine”), which recently merged with Orthofix Medical, Inc. ("Orthofix"), to develop a next generation device for sacropelvic fixation. Mr. Keith Valentine, who serves as the President, Chief Executive Officer and a member of the board of directors of SeaSpine, also serves as a member of the Company's Board of Directors since August 2015. On April 27, 2021, Addendum No.1 to the Development Agreement was entered into by and between the Company and SeaSpine to extend certain obligations as described under the Development Agreement to a consultant of the Company. On October 4, 2023, Keith C. Valentine resigned as a member of the Board of Directors of Orthofix. As such, subsequent to October 4, 2023, SeaSpine is no longer a related party of the Company.
Pursuant to the development plan, SeaSpine shall use reasonable efforts to assist in the development of the potential product offering, including licensing certain existing intellectual property to be incorporated into such product. Under the terms of the Development Agreement, the Company agreed to make monthly payments to SeaSpine to reimburse for full time resources employed by SeaSpine responsible to conduct the development activities. For the year ended December 31, 2023, the Company didnot incur any reimbursement charges but purchased an immaterial amount of instrument components from Seaspine. For the year ended December 31, 2022, the Company expensed $38,725 of reimbursement charges from SeaSpine. The reimbursement charges were recorded within research and development expense in the consolidated statement of operations.
Certain intellectual property developed pursuant to the project plan will be owned by the Company, certain intellectual property developed pursuant to the project plan will be owned by SeaSpine, and other intellectual property developed pursuant to the project plan will be jointly owned by SeaSpine and the Company. The Company also agreed to provide SeaSpine a royalty-free, worldwide, perpetual, non-exclusive license of certain of the Company's intellectual property incorporated into the product to be developed. The Company also agreed to pay SeaSpine a product royalty, in an amount specified in the Development Agreement, for each resulting product sold for a period of 10 years beginning on the initial market launch. The term of the Development Agreement shall continue until the expiration of all royalty terms, unless earlier terminated by either party, as provided for by the Development Agreement. The Company recorded $0.3 million of royaltyfor the year ended December 31, 2023. The Company recorded an immaterial amount of royaltyfor the year ended December 31, 2022.
Theoutstanding liability to SeaSpine as of December 31, 2023 and December 31, 2022 was $0.1 million and was recorded within accounts payable and accrued liabilities and other in the consolidated balance sheet.
- Subsequent Events
On January 25, 2024, the Company entered into a Second Amendment to Loan and Security Agreement (the “Second Amendment”) with SVB which amends the Company's First Amendment. The Second Amendment revised certain provisions related to financial covenants and the periods in which the covenants apply.
On February 23, 2024 the Company entered into a Manufacture and Supply Agreement with RMS Company, for the manufacture and supply of our requirements for iFuse-3D, iFuse-TORQ and components of iFuse Bedrock Granite implants. Pricing is set forth in the agreement through the end of 2026. The agreement has athree year initial term with automaticone-year renewals.
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