PROCEPT BioRobotics Corp
For the period ended Dec 31, 2023. Filed Feb 28, 2024.
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FY2023 · Filed Feb 28, 2024
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Notes to Consolidated Financial Statements F-
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
- Organization
Description of Business
PROCEPT BioRobotics Corporation (the “Company”) was incorporated in the state of California in 2007 and its headquarters are located in San Jose, California. In April 2021, the Company re-incorporated in the state of Delaware. The Company received U.S. Food and Drug Administration clearance in December 2017 to market its AquaBeam® Robotic System, an automated surgical robot providing tissue removal for the treatment of benign prostatic hyperplasia, a prostate gland enlargement condition.
Liquidity
As of December 31, 2023, the Company had cash and cash equivalents of $257.2 million and an accumulated deficit of $454.6 million. Since its inception, the Company has financed its operations with a combination of debt and equity financing arrangements. In August 2023, the Company completed our follow-on offering, which raised $161.7 million, net of issuance costs. The Company expects its cash and cash equivalents, and revenue will be sufficient to fund its operations through at least the next twelve months from the issuance date of these consolidated financial statements. The Company has not achieved positive cash flow from operations to date and expects to continue incurring losses for the foreseeable future as it focuses on growing its business.
- Summary of Significant Accounting Policies
Basis of Preparation
The consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) and pursuant to the rules and regulations of the United States Securities and Exchange Commission (“SEC”). These consolidated financial statements include the accounts of the Company and its consolidated subsidiaries. All intercompany balances and transactions have been eliminated upon consolidation.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts and disclosures reported in the consolidated financial statements. Management uses significant judgment when making estimates related to its stock-based compensation expense, right-of-use lease asset, lease liability, the valuations of the loan facility derivative liability, as well as certain accrued liabilities. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results could differ from those estimates.
Reverse Stock Split
In September 2021, the Board of Directors and stockholders approved, and the Company filed, an amended and restated certificate of incorporation effecting a 1-for-4.75 reverse stock split of common stock and all redeemable convertible preferred stock. The par value of the common and redeemable convertible preferred stock was not adjusted as a result of the reverse stock split. All authorized, issued and outstanding common stock, redeemable convertible preferred stock, warrants for preferred stock, stock options and per share amounts contained in the financial statements have been retroactively adjusted to reflect this reverse stock split for all periods presented.
Initial Public Offering
In September 2021, the Company completed its IPO by issuing 6,556,000 shares of common stock, and the exercise of the underwriters option for 983,400 shares, at an offering price of $25.00 per share, for total net proceeds of approximately $172.4 million, after deducting underwriting discounts and commissions of $13.2 million and offering expenses of $2.9 million. Offering costs are capitalized, and consist of fees and expenses incurred in connection with the sale of common stock in its IPO, including legal, accounting, printing and other IPO-related costs. Upon completion of its IPO, these deferred offering costs were reclassified to stockholders’ equity and recorded against the proceeds from the offering. In addition, all 29,912,264 shares of its then-outstanding redeemable convertible preferred stock automatically converted into 29,912,264 shares of common stock and it reclassified $329.5 million of redeemable convertible preferred stock to additional paid-in capital on its consolidated balance sheet.
Par Value and Shares Authorized Change
In June 2021, the Board of Directors and stockholders approved, and the Company filed, an amended and restated certificate of incorporation effecting a change in par value from $0.001 to $0.00001 per share of common stock and all redeemable convertible preferred stock.
Cash, Cash Equivalents and Restricted Cash
Cash and cash equivalents consist of cash in banks highly liquid securities determined to be cash equivalents, which are readily convertible into cash and mature within 90 days or less from the original date of purchase. Cash and cash equivalents include money market funds and U.S. treasury bills.
Cash equivalents are considered available-for-sale marketable securities and are recorded at fair value, based on quoted market prices. Unrealized gains and losses are recorded in other comprehensive gain (loss) and included as a separate component of stockholders’ equity.
Restricted cash is related to the Company’s letter of credit for the lease of its San Jose, CA location.
Fair Value of Financial Instruments
The Company measures certain financial assets and liabilities at fair value on a recurring basis, including cash and cash equivalents, and accounts receivable, accounts payable and accrued liabilities, which approximate fair value due to their relatively short maturities as well as the loan facility derivative liability. 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. A three-tier fair value hierarchy is established as a basis for considering such assumptions and for inputs used in the valuation methodologies in measuring fair value:
Level 1-Observable inputs such as quoted prices (unadjusted) for identical assets or liabilities in active markets.
Level 2-Other inputs that are based upon quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant inputs are observable in the market or can be derived from observable market data.
Level 3-Unobservable inputs that are supported by little or no market activities, which would require the Company to develop its own assumptions.
The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.
Concentration of Credit Risk
Financial instruments, which potentially subject the Company to concentrations of credit risk, consist principally of cash and cash equivalents and, to a lesser extent, accounts receivable. The Company believes that credit risk in its accounts receivable is mitigated by its credit evaluation process, relatively short collection terms and diversity of its customer base. The Company generally does not require collateral and losses on accounts receivable have historically been within management’s expectations.
No customers accounted for more than 10% of revenue during the year ended December 31, 2023, 2022 and 2021. No customers accounted for more than 10% of accounts receivable at December 31, 2023 and 2022.
The Company’s investment policy limits investments to certain types of debt securities issued by the U.S. government, its agencies, and institutions with investment-grade credit ratings, as well as corporate debt or commercial paper issued by the highest quality financial and non-financial companies, and places restrictions on maturities and concentration by type and issuer. The Company is exposed to credit risk in the event of a default by the financial institutions holding its cash and cash equivalents and issuers of investments to the extent recorded on the balance sheets. The Company has limited its credit risk associated with cash and cash equivalents by placing its investments with banks it believes are highly creditworthy and with highly rated investments.
Allowance for Doubtful Accounts
The Company’s expected loss allowance methodology is developed using its historical collection experience, current and future economic market conditions and a review of the current aging status and financial condition of its customers. Specific allowance amounts are established to record the appropriate allowance for customers that have a known risk of default. Balances are written off when they are ultimately determined to be uncollectible. The Company has not experienced any significant collection issues and the allowance for doubtful accounts has not been material.
Inventory
Inventories are valued at the lower of cost, computed on a first-in, first-out basis, or net realizable value. The allocation of production overhead to inventory costs is based on normal production capacity. Abnormal amounts of idle facility expense, freight, handling costs, and consumption are expensed as incurred, and not included in overhead. The Company maintains provisions for excess and obsolete inventory based on management’s estimates of forecasted demand and, where applicable, product expiration.
Property and Equipment and Intangible Assets
Property and equipment and intangible assets are stated at cost, less accumulated depreciation and amortization. Depreciation and amortization for property and equipment are determined using the straight-line method over the estimated useful lives of the respective assets, generally three tofive years. The Company reclassifies inventory used at customer sites for evaluation purposes to property and equipment due to a limited history of sales of evaluation units. Amortization of intangible assets are determined using the straight-line method over the estimated useful lives, generally through the patent expiration date. Leasehold improvements are amortized on a straight-line basis over the shorter of their estimated useful lives or the term of the lease. Maintenance and repairs are charged to operating expenses as incurred.
Impairment of Long-Lived Assets
Long-lived assets consist primarily of property and equipment and intangible assets, net, and are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If circumstances require that a long-lived asset be tested for possible impairment, the Company compares the undiscounted cash flows expected to be generated by the asset group to the carrying amount of the asset group. If the carrying amount of the long-lived asset is not recoverable on an undiscounted cash flow basis, an impairment is recognized to the extent that the carrying amount exceeds its fair value. The Company determines fair value using the income approach based on the present value of expected future cash flows or other appropriate measures of estimated fair value. The Company’s cash flow assumptions consider historical and forecasted revenue and operating costs and other relevant factors. No impairment losses were incurred in the periods presented.
Deferred Revenue
The timing of revenue recognition may differ from the timing of invoicing to customers. The Company records deferred revenue when revenue will be recognized subsequent to invoicing. Service agreements are generally invoiced annually at the beginning of each coverage period and recorded as deferred revenue and recognized as revenue ratably over the coverage period. Deferred revenue that will be recognized during the 12 months following the balance sheet date is recorded as the current portion of deferred revenue, and the remaining portion, if any, would be recorded as non-current.
Loan Facility Derivative Liability
In connection with the Company’s previous loan facility (Note 6), the Company is obligated to pay a fee upon the earlier occurrence of a defined liquidity event, including but not limited to, a merger or sale of our assets or voting stock, or achieving a $200.0 million trailing 12 months revenue target, in each case, by September 2029. The fee is calculated at the time of the liquidity event occurrence to be $1.0 million if only the first installment has been drawn, $2.0 million if the first two installments have been drawn, $2.4 million if the first three installments have been drawn, or $3.0 million if all four installments have been drawn, in each case, upon the occurrence of the liquidity event. At the time of extinguishment, the Company has drawn on the first two installments. The Company has determined this fee is a freestanding derivative instrument. The $1.9 million fair value of this loan facility derivative was initially recorded as a debt discount and a current liability on the date of issuance in connection with obtaining additional financing as applicable and will be revalued every reporting period until the earlier occurrence of a defined liquidity event or achieving a revenue target by September 2029 or termination of such fee arrangement.
Leases
For agreements with a term of more than 12 months, the Company determines if the agreement contains a lease at inception. Operating lease liabilities represent an obligation to make lease payments arising from the lease agreement. Operating lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the remaining lease term. In determining the present value of lease payments, the Company estimates its incremental borrowing rate as the rate of interest that the Company would have to pay to borrow on a collateralized basis over a similar term, of an amount equal to the lease payments in a similar economic environment. Operating lease liabilities are included in the Company’s consolidated balance sheet. Right-of-use assets represent our right to use an underlying asset for the lease term and are classified as non-current assets. Lease expense is recognized on a straight-line basis over the expected lease term in the Company’s consolidated statements of operations and comprehensive loss.
The Company has not elected to separate lease and non-lease components for any leases within its existing classes of assets and, as a result, records a right-of-use asset and lease liability based on the present value of the future minimum lease payments over the term at commencement date. Variable lease payments are expensed as incurred. The Company has also elected to not apply the recognition requirement to any leases within its existing classes of assets with a term of 12 months or less and does not include an option to purchase the underlying asset that the Company is reasonably certain to exercise.
The Company has lessor arrangements with customers for a fixed monthly fee with no non-lease components, typically for 3-12 months. These arrangements are accounted for as an operating lease in accordance with ASC 842. These arrangements and related revenue are immaterial to the periods presented.
Revenue Recognition
Revenue is derived primarily from the sales of the AquaBeam® Robotic Systems, and handpieces that are for one-time use during each surgery using the AquaBeam Robotic System. The AquaBeam Robotic System contains both software and non-software components that are delivered together as a single product and generally contain aone-year warranty.
To determine revenue recognition for arrangements that the Company determines are within the scope of ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”), the Company performs the following five steps: (i) identify the contract with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when, or as, the Company satisfies the performance obligations. The Company only applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determined those that are performance obligations and assess whether each promised good or service is distinct based on the contract.
The contracts are typically in the form of a master agreement and a purchase order from the customer. The Company’s AquaBeam Robotic System sales generally contain multiple products and services and can include a combination of the following performance obligations: robotic system, handpieces and consumables, and service.
The Company determines the transaction price it expects to be entitled to in exchange for transferring the promised product to the customer, which is based on the invoiced price for the products. All prices are at fixed amounts per the sales agreement with the customer.The Company generally issues no discounts or other price concessions or a right of return, once the agreement is signed. The Company has granted rebates on a limited basis, and those rebates have been historically immaterial.
For multiple-element arrangements, revenue is allocated to each performance obligation based on its relative standalone selling price. Standalone selling prices are based on observable prices at which the Company separately sells the products or services. If a standalone selling price is not directly observable, then the Company estimates the standalone selling price considering market conditions and entity-specific factors including, but not limited to, features and functionality of the products and services, geographies, and type of customer. The Company regularly reviews standalone selling prices and update these estimates as necessary.
The Company recognizes revenue as the performance obligations are satisfied by transferring control of the product or service to a customer. The Company generally recognizes revenue for the performance obligations at the following points in time:
AquaBeam Robotic Systems - For systems (including system components and system accessories) sold directly to end customers, revenue is recognized when the Company transfers control to the customer, which is generally at the time of delivery. For systems sold through distributors, revenue is recognized generally at the time of delivery to the distributor. The Company’s system arrangements generally do not provide a right of return. The systems are generally covered by aone-year service agreement included in the warranty. The service agreements have a stand alone selling price and are typically recognized as deferred revenue and amortized over theone-year service period.
Hand pieces and other consumables - Revenue from sales of handpieces and other consumables is recognized when control is transferred to the customers, which generally occurs at the time of shipment but also occurs at the time of delivery.
Service - Service revenue, inclusive of the amounts associated with the AquaBeam Robotic System warranties, is recognized over the term of the service period, as the customer benefits from the services throughout the service period.
The Company has determined that certain promises in the multiple-element arrangements, such as installation, training and certain ancillary products, are immaterial, and do not represent separate performance obligations for which transaction price is allocated.
The timing of revenue recognition may differ from the timing of invoicing to customers. The Company records deferred revenue when revenue is recognized subsequent to invoicing, such as service contracts, which are recognized ratably as revenue over the performance period.
The Company’s typical payment terms are between approximately 30 to 90 days. The Company expenses shipping and handling costs as incurred and includes them in the cost of sales. In those cases where shipping and handling costs are billed to customers, the Company classifies the amounts billed as a component of revenue. Taxes collected from customers and remitted to governmental authorities are excluded from revenue. The Company expenses any incremental costs of obtaining a contract, including but not limited to, sales commissions, as and when incurred as the expected amortization period of the incremental costs would have been less than one year and are reported in selling, general and administrative expense in the statements of operations and comprehensive loss.
The Company utilizes the practical expedient under ASC 606 and does not disclose unsatisfied performance obligations for service contracts as these contracts generally have an original duration of less than one year. For those contracts with an original duration exceeding one year, the aggregate amount of transaction price allocated to the performance obligations unsatisfied at December 31, 2023 was not material.
Cost of Sales
Cost of sales consists primarily of manufacturing overhead costs, material costs and direct labor, including stock-based compensation. A significant portion of the Company’s cost of sales currently consists of manufacturing overhead costs. These overhead costs include the cost of quality assurance, material procurement, inventory control, facilities, equipment and operations supervision and management. Cost of sales also includes depreciation expense for production equipment, warranty, and field service costs, and purchased intangibles and certain direct costs such as shipping costs.
Research and development costs are expensed as incurred. Research and development costs consist primarily of engineering, product development, and regulatory affairs, consulting services, materials, depreciation and other costs associated with products and technologies being developed, including employee and non-employee compensation, stock-based compensation, supplies, quality assurance expenses, related travel expenses and facilities expenses.
Stock-Based Compensation
The Company accounts for stock options granted to employees and directors under the fair value recognition provision of ASC 718, Compensation -Stock Compensation. Stock-based compensation expense is recognized over the requisite service period in the statements of operations and comprehensive loss. The Company uses the straight-line method for expense attribution.
The Company estimates the fair value of stock options on the date of grant using the Black-Scholes option-pricing model. The Black-Scholes model determines the fair value of stock-based payment awards based on the fair market value of the Company’s common stock on the date of grant and is affected by assumptions regarding a number of highly complex and subjective variables. These variables include, but are not limited to, the fair market value of the Company’s common stock, volatility over the expected term of the awards and actual and projected employee stock option exercise behaviors. The Company has opted to use the “simplified method” for estimating the expected term of options, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the option. Due to the Company’s limited operating history and limited company specific historical and implied volatility data, the Company has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. When selecting these public companies on which it has based its expected stock price volatility, the Company generally selected companies with comparable characteristics to it, including enterprise value, stages of clinical development, risk profiles, position within the industry and with historical share price information sufficient to meet the expected life of the stock-based awards. The historical volatility data was computed using the daily closing prices for the selected companies’ shares during the equivalent period of the calculated expected term of the share-based payments. The Company will continue to analyze the historical stock price volatility and expected term assumptions as more historical data for the Company’s common stock becomes available. The risk-free rate assumption is based on the U.S. Treasury instruments with maturities similar to the expected term of the Company’s stock options. The expected dividend assumption is based on the Company’s history of not paying dividends and its expectation that it will not declare dividends for the foreseeable future. The Company has elected to account for forfeitures when they occur.
The Company accounts for the fair value of restricted stock units (“RSUs”) using the closing market price of the Company’s common stock on the date of the grant. Stock-based compensation cost for RSUs is measured at the grant date based on the estimated fair value of the award and is recognized as expense over the requisite service period (generally the vesting period), net of forfeitures.
Advertising Expenses
The Company expenses the costs of advertising, including promotional expenses, as incurred. Advertising expenses for the years ended December 31, 2023, 2022, and 2021 were $0.3 million, $0.1 million, and $0.1 million respectively.
Income Taxes
The Company accounts for income taxes under the asset and liability method. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates that will be in effect when the differences are expected to reverse. Valuation allowances against deferred tax assets are established when necessary to reduce deferred tax assets to the amounts expected to be realized. Currently, the Company has recorded a full valuation allowance against its deferred tax assets and there is no provision for income taxes, as the Company has incurred operating losses to-date. The Company’s policy is to record interest and penalties related to uncertain tax positions as a component of income tax expense in the statement of operations. To date, there have been no interest or penalties charged in relation to the unrecognized tax benefits.
Net Loss Per Share
Basic net loss per share is computed by dividing the net loss by the weighted-average number of shares of common stock outstanding during the period. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of shares of common stock and common stock equivalent shares from dilutive stock options and common stock warrants outstanding during the period. Because the Company has reported a net loss for all periods presented, diluted net loss per share is the same as basic net loss per share for those periods as all potentially dilutive securities were antidilutive in those periods.
The Company allocates no loss to participating securities because they have no contractual obligation to share in the losses of the Company. The shares of the Company’s redeemable convertible preferred stock participated in any dividends declared by the Company and were therefore considered to be participating securities.
Comprehensive Gain (Loss)
Comprehensive gain (loss) consists of net gains (losses) and changes in unrealized gains and losses on cash equivalents. Accumulated other comprehensive loss is presented in the accompanying balance sheets, when applicable.
Segment Information
The Company operates as a single operating segment. The Company’s chief operating decision maker, its Chief Executive Officer, reviews financial information on an aggregate basis for the purposes of allocating resources and evaluating financial performance.
Recently Adopted Accounting Pronouncements
None.
Recent Accounting Pronouncements
In December 2023, the Financial Accounting Standards Board or FASB, issued Accounting Standards Update (“ASU”) 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which includes amendments that further enhance income tax disclosures, primarily through standardization and disaggregation of rate reconciliation categories and income taxes paid by jurisdiction. The amendments are effective for all public entities for fiscal years beginning after December 15, 2024. Early adoption is permitted and should be applied either prospectively or retrospectively. The Company plans to adopt the ASU and related updates on January 1, 2025. The Company is evaluating the impact of this ASU will have on its financial statement disclosures.
- Fair Value Measurements
The following is a summary of assets and liabilities measured at fair value on a recurring basis (in thousands):
| December 31, | ||||||||
|---|---|---|---|---|---|---|---|---|
| 2023 | 2022 | |||||||
| Level 1 | Level 2 | Level 3 | Total | Level 1 | Level 2 | Level 3 | Total | |
| Cash and cash equivalents: | ||||||||
| Cash | $6,609 | $— | $— | $6,609 | $8,870 | $— | $— | $8,870 |
| Cash equivalents | 250,613 | — | — | 250,613 | 212,989 | — | — | 212,989 |
| Total cash and cash equivalents | $257,222 | $— | $— | $257,222 | $221,859 | $— | $— | $221,859 |
| Loan facility derivative liability | $— | $— | $1,886 | $1,886 | $— | $— | $1,779 | $1,779 |
The carrying amounts of the Company’s cash and cash equivalents, accounts receivable and accounts payable approximate their fair values due to their short maturities. The Company’s long-term debt is recorded at its net carrying value, which approximates fair value.
There were no transfers in and out of Level 3 during the years ended December 31, 2023 and 2022.
Loan facility derivative liability
The following table sets forth a summary of the changes in the estimated fair value of the Company’s loan facility derivative liability, classified as Level 3 (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Beginning of the period | $1,779 | $1,496 |
| Change in fair value | 107 | 283 |
| End of the period | $1,886 | $1,779 |
The fair value of the loan facility derivative liability was determined using a discounted cash flow calculation discounted at 6%.
- Composition of Certain Consolidated Financial Statement Items
Inventory (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Raw materials | $16,737 | $12,417 |
| Work-in-process | 1,142 | 1,738 |
| Finished goods | 21,877 | 14,388 |
| Total inventory | $39,756 | $28,543 |
Property and Equipment, Net (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Laboratory, manufacturing and computer equipment, and furniture and fixtures | $15,610 | $3,260 |
| Rental equipment | 897 | 1,313 |
| Leasehold improvements | 12,362 | 4,941 |
| Evaluation units | — | 2,475 |
| Construction in progress | 3,548 | 5,671 |
| Total property and equipment | 32,417 | 17,660 |
| Less: accumulated depreciation and amortization | (3,669) | (9,004) |
| Total property and equipment, net | $28,748 | $8,656 |
Other Current Liabilities (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Accrued purchases | 106 | 2,006 |
| Professional services | 1,558 | 1,739 |
| Sales tax | 1,725 | 829 |
| Interest | 333 | 532 |
| Travel expenses | 519 | 429 |
| Asset retirement obligation | 232 | 200 |
| Clinical trial expenses | 392 | 175 |
| Other | 1,453 | 1,558 |
| Total other current liabilities | $6,318 | $7,468 |
As of December 31, 2022, other non-current liabilities consisted of an asset retirement obligation for the facility lease which was terminated as of December 31, 2023.
Interest and Other Income (Expense), net (in thousands):
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Interest income | $7,551 | $2,497 | $76 |
| Decrease in fair value of preferred stock warrants | — | — | 64 |
| Change in fair value of loan facility derivative liability | (107) | (283) | 135 |
| Other | (176) | (203) | (154) |
| Total interest and other income, net | $7,268 | $2,011 | $121 |
- Intangible Assets
In March 2019, the Company entered into a license agreement with HydroCision, Inc. This agreement grants the Company an exclusive, perpetual, irrevocable, worldwide, fully paid-up license to develop, manufacture and commercialize products in the field of urology using the patented technology and know-how controlled by HydroCision as of the effective date and as well as new patented technology developed by HydroCision that cover certain activities and improvements that relate to the use of fluid jet technology in connection with the licensed products during the period commencing on the effective date and ending on the earlier of the date that the Company ceases to use HydroCision’s existing contract manufacturers and the third anniversary of the effective date. Also included is the right to utilize HydroCision’s contract manufacturers, if desired. The consideration paid was a one-time upfront payment of $2.5 million, as well as allowing HydroCision (a reciprocal license) to use any new patented technology and know-how developed by the Company relating to the HydroCision patented technology and know-how in the field of urology for HydroCision use outside the field of urology. HydroCision will pay for any patent maintenance fees on HydroCision’s licensed patents. As of December 31, 2023 and 2022, accumulated amortization was $1.3 million and $1.0 million, respectively, and the net carrying amount is expected to be amortized at a rate of $0.3 million per year until fully amortized.
Amortization expense for intangible assets for the years ended December 31, 2023, 2022, and 2021 was $0.3 million respectively.
- Long-Term Debt
In October 2022, the Company entered into a loan and security agreement (“The Agreement”) with Canadian Imperial Bank of Commerce, or CIBC. The Agreement provides for a senior secured term loan facility in the aggregate principal amount of $52.0 million (the "Term Loan Facility") which was borrowed in full.
The Term Loan Facility was used to repay and terminate the Company's previous loan facility, transaction fees, and related expenses.
The Term Loan Facility is scheduled to mature on the fifth anniversary of the Closing Date (the "Maturity Date"). The Agreement provides for interest-only payments on the Term Loan Facility for the first thirty-six months following the Closing Date (the "Initial Interest-Only Period"). The Initial Interest-Only Period will be extended to an additional twelve months if the Company achieves either (i) $200.0 million or greater in revenue in any twelve-month period or (ii) $0 or greater in EBITDA in any six-month period. Thereafter, amortization payments on the Term Loan Facility will be payable monthly until the Maturity Date in monthly installments equal to 20% of the then outstanding principal amount of the Term Loan Facility divided by 12 plus any accrued and unpaid interest. The Company has the option to prepay the Term Loan Facility without any prepayment charge or fee.
The loan borrowed under the Term Loan Facility bears interest at an annual rate equal to the secured overnight financing rate ("SOFR") (calculated based on an adjustment of.10%,.15% and.25%, respectively, for one-month, three-month or six-month term SOFR as of a specified date, subject to a floor of 1.5%) plus an applicable margin of 2.25%.
The obligations under the Loan Agreement are secured by substantially all of the Company's assets, including its intellectual property and by a pledge all of the Company's equity interests in its U.S. subsidiaries and 65% of the Company's equity interests in its non-U.S. subsidiaries that are directly owned by the Company. In June 2023, the Term Loan Facility was amended to lower the amount the Company is obligated to maintain in deposit accounts held at the lender to the lesser of (i) $90.0 million or (ii) all of its non-operating cash and allow the Company to maintain cash or cash equivalents in excess of that amount with other financial institutions.
The Company recorded a loss on loan extinguishment in the amount of $3.3 million in its consolidated statements of operations and comprehensive loss at December 31, 2022. The loss was attributed to the acquisition price of the CIBC debt exceeded the carrying amount of the Company’s previous loan facility.
- Stock-Based Compensation
2021 Equity Incentive Award Plan
In September 2021, the Company adopted the 2021 Equity Incentive Award Plan (the “2021 Plan”), which allows for the granting of stock options and stock purchase rights to the employees, members of the board of directors, and consultants of the Company. A total of 7,729,013 shares of common stock were reserved for issuance under the 2021 Plan. Options granted under the 2021 Plan may be either incentive stock options (“ISOs”) or nonqualified stock options (“NSOs”). ISOs may be granted only to the Company’s employees, including officers and directors who are also employees. NSOs may be granted to employees and consultants.
Options under the 2021 Plan may be granted for periods of up to 10 years and at prices no less than 100% of the estimated fair value of the shares on the date of grant as determined by the board of directors, provided, however, that the exercise price of an ISO and NSO granted to a 10% shareholder shall not be less than 110% of the estimated fair value of the shares on the date of grant.
Granted options for newly hired employees usually vest over four years monthly with aone-year cliff vesting, and follow-on options vest monthly over four years with no cliff vesting. Options granted to consultants have various vesting schedules depending on the underlying consulting arrangement and anticipated period of service. Granted restricted stock units usually vest over four years annually. As of December 31, 2023, there were 5.2 million shares available for grant and 2.3 million awards outstanding under the 2021 Plan.
2008 Stock Plan
The Company ceased making awards under the 2008 Stock Plan upon the effective date of the Company’s IPO. In 2008, the Company adopted the 2008 Stock Plan (the “2008 Plan”), which allows for the granting of stock options and stock purchase rights to the employees, members of the board of directors, and consultants of the Company. Options granted under the 2008 Plan may be either incentive stock options (“ISOs”) or nonqualified stock options (“NSOs”). ISOs may be granted only to the Company’s employees, including officers and directors who are also employees. NSOs may be granted to employees and consultants. Options granted under the 2008 Plan will start expiring in August 2021. Options outstanding under the 2008 Plan will expire upon forfeiture. As of December 31, 2023,4.5 million options were outstanding under the 2008 Plan.
2021 Employee Stock Purchase Plan
In September 2021, the Company adopted the 2021 Employee Stock Purchase Plan (the “2021 ESPP”). The 2021 ESPP became effective on the effective date of the IPO. A total of 412,988 shares were initially reserved for issuance under the 2021 ESPP. Additionally, the number of shares of common stock reserved for issuance under the 2021 ESPP will increase automatically each year, beginning on January 1, 2022, and continuing through and including January 1, 2031, by the lesser of (1)1% of the total number of shares of common stock outstanding on December 31 of the preceding calendar year; or (2) such lesser number as determined by the Company’s board of directors. The number of shares that may be issued under the 2021 ESPP shall not exceed a total of 10,526,315 shares. As of December 31, 2023, approximately 245,000 shares have been issued under the 2021 ESPP. As of December 31, 2023, there were 1.1 million shares available for grant under the 2021 ESPP.
Total stock-based compensation recognized, before taxes, are as follows (in thousands):
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Cost of sales | $2,493 | $1,053 | $253 |
| Research and development | 4,798 | 2,230 | 783 |
| Sales, general and administrative | 14,401 | 7,387 | 2,760 |
| Stock-based compensation capitalized in inventory | $(2,558) | $(333) | — |
| Total stock-based compensation | $19,134 | $10,337 | $3,796 |
Stock Options
A summary of the Company’s stock option activity and related information are as follows (options in thousands):
| Year Ended | ||
|---|---|---|
| Options | Weighted Average Exercise Price | |
| Outstanding, beginning of period | 5,353 | $6.93 |
| Granted | 398 | 36.83 |
| Exercised | (520) | 4.77 |
| Forfeited | (16) | 11.62 |
| Outstanding, end of period | 5,215 | 9.42 |
| Vested and expected to vest | 5,215 | 9.42 |
| Exercisable | 4,042 | 6.80 |
The weighted-average grant date fair value of options granted during the years of December 31, 2023 and 2022 was $21.02 and $19.15, respectively. As of December 31, 2023, the aggregate pre-tax intrinsic value of options outstanding and exercisable was $144.0 million and options outstanding were $169.5 million. The aggregate pre-tax intrinsic value of options exercised was $15.4 million and $29.8 million during the years ended December 31, 2023 and 2022, respectively. The aggregate pre-tax intrinsic value was calculated as the difference between the exercise prices of the underlying options and the estimated fair value of the common stock on the date of exercise. The total fair value of options vested was $5.8 million and $4.8 million during the years ended December 31, 2023 and 2022, respectively.
As of December 31, 2023, total unrecognized stock-based compensation related to unvested stock options was $10.9 million, which the Company expects to recognize over a remaining weighted-average period of 2.4 years.
The fair value of the options granted to employees or directors was estimated as of the grant date using the Black-Scholes model assuming the weighted-average assumptions listed in the following table:
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Expected life (years) | 6.0 | 5.9 | 6.0 |
| Expected volatility | 57% | 55% | 50% |
| Risk-free interest rate | 4.0% | 2.5% | 1.0% |
| Expected dividend rate | —% | —% | —% |
| Weighted-average fair value | $21.02 | $19.15 | $4.36 |
Restricted Stock Units
A summary of the Company’s restricted stock unit or RSU activity and related information are as follows (RSUs in thousands):
| Year Ended | ||
|---|---|---|
| Restricted Stock Units | Weighted-AverageFair Value | |
| Outstanding, beginning of period | 742 | $36.35 |
| Granted | 1,144 | 36.16 |
| Canceled/forfeited | (119) | 35.31 |
| Released | (202) | 36.50 |
| Outstanding, end of period | 1,565 | 36.27 |
The weighted-average grant date fair value of RSUs granted during the years of December 31, 2023 and 2022 was $36.16 and $36.23, respectively.
As of December 31, 2023, the aggregate pre-tax intrinsic value of RSUs outstanding was $65.6 million, calculated based on the closing price of the Company’s common stock at the end of the period.
As of December 31, 2023, total unrecognized stock-based compensation related to unvested RSUs was $46.0 million, which the Company expects to recognize over a remaining weighted-average period of 3.0 years.
Employee Stock Purchase Plan
As of December 31, 2023, there was approximately $0.8 million of unrecognized cost related to employee stock purchases under the 2021 ESPP. This cost is expected to be recognized over a weighted average period of 0.4 years. As of December 31, 2023, a total of 1.1 million shares were available for issuance under the 2021 ESPP.
The fair value of the options granted under the 2021 ESPP to employees was estimated as of the grant date using the Black-Scholes model assuming the weighted-average assumptions listed in the following table:
| Year Ended December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Expected life (years) | 0.7 | 0.7 |
| Expected volatility | 53% | 56% |
| Risk-free interest rate | 5.1% | 4.2% |
| Expected dividend rate | —% | —% |
| Weighted-average fair value | $11.20 | $15.11 |
There wereno shares issued under the ESPP for the year ended December 31, 2021.
- Income Taxes
The Company didnot record an income tax provision for the periods presented.
Reconciliation between the tax provision computed at the federal statutory income tax rate and the Company's actual effective income tax rate are as follows:
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Federal statutory tax rate | 21% | 21% | 21% |
| R&D tax credit | 1 | 2 | 2 |
| Stock-based compensation and other permanent differences | (1) | 2 | — |
| Change in valuation allowance | (21) | (25) | (23) |
| Total | —% | —% | —% |
The Company’s income taxes are accounted for in accordance with authoritative guidance, which requires the use of the asset and liability method. Under this method, deferred income tax assets and liabilities are determined based upon the difference between the consolidated financial statement carrying amounts and the tax basis of assets and liabilities and are measured using the enacted tax rate expected to apply to taxable income in the years in which the differences are expected to be reversed.
Significant components of net deferred tax assets are as follows (in thousands):
| December 31, | ||
|---|---|---|
| 2023 | 2022 | |
| Deferred tax assets: | ||
| Net operating losses | $80,273 | $65,197 |
| Property and equipment | 203 | 847 |
| R&D tax credit | 9,224 | 7,346 |
| Stock-based compensation | 3,829 | 2,082 |
| Capitalized R&D expenses | 20,644 | 12,971 |
| Inventory | 2,708 | 2,279 |
| Lease liability | 6,824 | 6,404 |
| Accruals and reserves | 2,713 | 2,758 |
| Total deferred tax assets | 126,418 | 99,884 |
| Valuation allowance | (121,461) | (94,056) |
| Net deferred tax assets | 4,957 | 5,828 |
| Deferred tax liabilities: | ||
| Right-of-use assets | (4,957) | (5,828) |
| Total deferred tax liabilities | (4,957) | (5,828) |
| Net deferred tax assets | $— | $— |
The Company has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets. Based on the Company's history of operating losses, the Company has concluded that it is more likely than not that the benefit of its deferred tax assets will not be realized. The valuation allowance increased by $27.4 million during the year ended December 31, 2023.
As of December 31, 2023 and 2022, the Company has U.S. federal net operating loss (“NOL”) carryforwards of approximately $326.3 million and $264.6 million, respectively, expiring beginning 2028. As of December 31, 2023 and 2022, the Company has U.S. state and local NOL carryforwards of approximately $194.0 million and $155.7 million, respectively, expiring beginning 2028.
As of December 31, 2023 and 2022, the Company has federal research and development credit carryforwards of approximately $7.5 million and $6.0 million, respectively, available to reduce future taxable income, if any. As of December 31, 2023 and 2022, the Company has California research and development credit carryforwards of approximately $6.0 million and $4.8 million, respectively, available to reduce future taxable income, if any.
The federal research and development credit carryforwards expire beginning 2028 and California research and development credit carryforwards are indefinite.
Internal Revenue Code section 382 places a limitation (the “Section 382 Limitation”) on the amount of taxable income that can be offset by net operating carryforwards after a change in control of a loss corporation. Generally, after a change in control, a loss corporation cannot deduct operating loss carryovers in excess of the Section 382 limitation. The Company has not performed an analysis to determine if a limitation applies and whether the limitation would cause the net operating losses to expire un-utilized.
The Company files federal, state, and foreign income tax returns. The tax periods 2008 through 2023 remain open in most jurisdictions. In addition, any tax losses that were generated in prior years and carried forward may also be subject to examination by respective authorities. The Company is not currently under examination by federal, state or foreign income tax authorities.
One of the provisions under the Tax Cuts and Jobs Act that became effective in tax years beginning after December 31, 2021 required the capitalization and amortization of research and experimental expenditures. The change in this US tax law did not have an impact on the Company's consolidated financial statements. The Company will continue to evaluate the impact of this tax law change on future periods.
On August 16, 2022, President Biden signed the Inflation Reduction Act of 2022 ( the Inflation Act) into law. The Inflation Act contains certain tax measures, including a corporate alternative minimum tax of 15% on some large corporations and an excise tax of 1% on corporate stock buy-backs. The various provisions of the Inflation Act did not have an impact on the Company’s consolidated financial statements and related notes.
A reconciliation of the change in the unrecognized tax benefit during the year is as follows (in thousands):
| December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Beginning of year | $2,700 | $1,917 | $1,407 |
| Additions for tax positions related to: | |||
| Current year | 842 | 783 | 510 |
| Prior years | (150) | — | — |
| End of year | $3,392 | $2,700 | $1,917 |
As of December 31, 2023, the Company had a total of $3.4 million of gross unrecognized tax benefits, none of which would affect the effective tax rate upon realization. The Company currently has a full valuation allowance against its U.S. net deferred tax assets which would impact the timing of the effective tax rate benefit should any of these uncertain tax positions be favorably settled in the future.
The Company does not expect the unrecognized tax benefits to change significantly over the next 12 months. The Company will recognize interest and penalties accrued on any unrecognized tax benefits as a component of income tax expense. As of December 31, 2023, the Company hasnot accrued interest or penalties related to uncertain tax positions.
- Net Loss Per Share
Net loss per share was determined as follows (in thousands, except per share amounts):
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Net loss | $(105,897) | $(87,154) | $(59,853) |
| Weighted-average common stock outstanding | 47,255 | 44,400 | 16,480 |
| Net loss per share, basic and diluted | $(2.24) | $(1.96) | $(3.63) |
The following potentially dilutive securities outstanding have been excluded from the computations of weighted-average shares outstanding because such securities have an antidilutive impact due to losses reported (in common stock equivalent shares, in thousands):
| December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Common stock options | 5,215 | 5,353 | 6,365 |
| Restricted stock units | 1,565 | 742 | 35 |
| Employee stock purchase plan | 80 | 110 | 193 |
| Total | 6,860 | 6,205 | 6,593 |
- Geographical Information
The following table presents revenue disaggregated by type and geography (in thousands):
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| U.S. | |||
| System sales and rentals | $53,626 | $36,527 | $19,375 |
| Handpieces and other consumables | 64,051 | 28,543 | 8,893 |
| Service | 6,620 | 2,698 | 680 |
| Total U.S. revenue | 124,297 | 67,768 | 28,948 |
| Outside of U.S. | |||
| System sales and rentals | 5,294 | 3,201 | 2,493 |
| Handpieces and other consumables | 5,471 | 3,273 | 2,634 |
| Service | 1,129 | 772 | 398 |
| Total outside of U.S. revenue | 11,894 | 7,246 | 5,525 |
| Total revenue | $136,191 | $75,014 | $34,473 |
For the year ended December 31, 2023 and 2022, substantially all of the Company’s long-lived assets are held in the United States.
- Commitments and Contingencies
Guarantees and Indemnifications
In the normal course of business, the Company enters into agreements that contain a variety of representations and provide for general indemnification. The Company’s exposure under these agreements is unknown because it involves claims that may be made against the Company in the future. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations. As of December 31, 2023, the Company does not have any material indemnification claims that were probable or reasonably possible and consequently has not recorded related liabilities.
Facility Leases
The Company previously leased a facility located in Redwood City, California. In September 2023, the Company exited the facility. In October 2023, the lease expired and was not renewed.
In December 2021, the Company entered into a lease fortwo existing buildings, comprising approximately 158,221 square feet of space, located in San Jose, California. The lease commenced in July 2022, and will continue for 122 months following thereafter, withtwo five year options to extend the term of the lease.
The Company began operations in at this facility in September 2023. The lease provides for annual base rent of $4.3 million for the first year, which increases on a yearly basis up to $5.5 million for the tenth year, for an aggregate of $49.2 million. Under the terms of the lease, the Company expects to receive an allowance of up to $7.9 million from the landlord to be applied to the Company’s construction of tenant improvements following the landlord’s delivery of thetwo buildings to the Company. During the year ended December 31, 2022, the Company recorded both an right-of-use asset and liability of $22.7 million related to the lease. The lease agreement provides for an escalation of rent payments each year and the Company records rent expense on a straight-line basis over the term of the lease. Rent is payable monthly.
The following table presents supplemental lease information:
| Year Ended December 31, | |||
|---|---|---|---|
| 2023 | 2022 | 2021 | |
| Weighted-average lease term | 9.2 years | 9.4 years | 1.8 years |
| Weighted-average discount rate | 8.5% | 8.7% | 10.8% |
Rent expense recognized under the leases, including additional rent charges for utilities, parking, maintenance and real estate taxes, was $8.4 million, $5.1 million and $2.7 million for the years ended December 31, 2023, 2022, and 2021, respectively.
Future minimum annual operating lease and debt repayments are as follows (in thousands):
| As of December 31, 2023 | Minimum Lease Payments | Debt Repayments | Total |
|---|---|---|---|
| 2024 | $4,184 | $— | $4,184 |
| 2025 | 4,297 | 4,333 | 8,630 |
| 2026 | 4,426 | 26,000 | 30,426 |
| 2027 | 4,808 | 21,667 | 26,475 |
| 2028 | 4,952 | — | 4,952 |
| Thereafter | 22,297 | — | 22,297 |
| Total minimum payments | 44,964 | 52,000 | 96,964 |
| Less: amount representing interest/unamortized debt discount/tenant improvement allowance | (17,099) | (661) | (17,760) |
| Present value of future payments | 27,865 | 51,339 | 79,204 |
As of December 31, 2023 and 2022, the Company’s security deposit is in the form of, and recorded as, restricted cash.
- Defined Contribution Plan
The Company has a defined contribution retirement savings plan under Section 401(k) of the Internal Revenue Code. This plan allows eligible employees to defer a portion of their annual compensation on a pre-tax basis. Employer contributions were $1.5 million, $0, and $0 for the year ended December 31, 2023, 2022, and 2021, respectively.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.