RxSight Inc
For the period ended Sep 30, 2024. Filed Nov 7, 2024.
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Sep 30, 2024 · Filed Nov 7, 2024
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Notes to Unaudited Condensed Consolidated Financial Statements
Note 1 - Organization and Basis of Presentation
Description of Business
RxSight®, Inc. (the “Company”) is a Delaware corporation headquartered in Aliso Viejo, California withone wholly owned subsidiary located in Amsterdam, Netherlands (“RxSight, B.V.”). RxSight, B.V. has a registered branch in the United Kingdom and a wholly owned subsidiary located in Germany (“RxSight GmbH”). The Company is engaged in the research and development, manufacture and sale of light adjustable intraocular lenses used in cataract surgery along with capital equipment used with the lenses.
The Company’s products, which include the light adjustable lens® (“LAL™” and “LAL+™”, and collectively the “LAL”) and a specially designed machine for delivering light to the eye, the Light Delivery Device (“LDD™”), are approved by the United States (“U.S.”) Food and Drug Administration (“FDA”) primarily for sale in the U.S. and have regulatory approval in the U.S., Europe, Canada and Mexico. The Company began marketing its products in 2019. The LAL is a premium intraocular lens (“IOL”) which is partially reimbursable under Medicare. The Company competes with other IOLs in the premium market.
The accompanying unaudited condensed consolidated financial statements include the accounts of RxSight, Inc. and its wholly owned subsidiaries, RxSight, B.V. and RxSight GmbH. All significant inter-company balances and transactions have been eliminated in consolidation.
Basis of Presentation and Principles of Consolidation
The Company’s condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial information and pursuant to Form 10-Q and Article 10 of Regulation S-X of the Securities and Exchange Commission (“SEC”). Accordingly, the accompanying unaudited condensed consolidated financial statements do not include all of the information and notes required by GAAP for complete financial statements. The unaudited interim financial statements reflect all adjustments which, in the opinion of management, are necessary for a fair statement of the results for the periods presented. All such adjustments are of a normal and recurring nature. The December 31, 2023 balance sheet data was derived from audited financial statements; however, the accompanying notes to the condensed consolidated financial statements do not include all of the annual disclosures required under GAAP and should be read in conjunction with the audited consolidated financial statements included in the Company’s 2023 Annual Report on Form 10-K filed with the SEC on February 28, 2024. The operating results presented in these unaudited condensed consolidated financial statements are not necessarily indicative of the results that may be expected for any future periods.
Operating Segments
The Company determined its operating segment on the same basis that it uses to evaluate its performance internally. The Company’s chief operating decision-maker (“CODM”), its Chief Executive Officer, reviews its consolidated operating results for the purpose of allocating resources and evaluating financial performance. The Company determined that it operates and manages its business (including its non-U.S. subsidiaries) inone reportable segment: the research and development, manufacture and sale of light adjustable lenses and related capital equipment.
Liquidity
Shelf Registration Statement
On May 8, 2024, the Company filed an automatic shelf registration statement on Form S-3 (“shelf registration statement”). The shelf registration statement is effective for three years and permits the Company to sell, from time to time, common stock, preferred stock, debt securities, warrants, and/or units. The shelf registration statement is intended to provide the Company with flexibility to access additional capital. At the time of filing the shelf registration statement, the Company also filed a prospectus supplement to sell up to an aggregate value of $115.0 million dollars of common stock through a public offering (“Public Offering”).
Public Offering
On May 8, 2024, the Company entered into an underwriting agreement with BofA Securities, Inc., in which the Company agreed to issue and sell 1,785,714 shares of the Company's common stock in a public offering, pursuant to the shelf registration statement. The shares of common stock were sold at a price to the public of $56.00 per share. Under the terms of the underwriting agreement, the Company also granted the underwriters an option exercisable for 30 days from the date of the underwriting agreement to purchase up to an additional 267,857 shares of common stock on the same terms and conditions. The underwriters' option was exercised in full on May 10, 2024 and the Public Offering (inclusive of the underwriters' option shares) closed on May 13, 2024. The Company received net proceeds of $107.5 million from the Public Offering, after deducting underwriters' discounts and commissions of $6.9 million and other offering expenses of $0.6 million.
As of September 30, 2024 and December 31, 2023 the Company had cash, cash equivalents and short-term investments of$237.1 million and$127.2 million, respectively.
The Company began generating revenue from its principal operations in 2019. The Company has a limited operating history, and the revenue and income potential of the Company’s business and market are unproven. The Company has experienced recurring net losses and negative cash flows from operating activities since its inception. For the three months ended September 30, 2024 and 2023, the Company incurred losses from operations of$9.2 million and$12.5 million, respectively. For the nine months ended September 30, 2024 and 2023, the Company incurred losses from operations of$28.2 million and$39.2 million, respectively. Based on the Company’s anticipated sales growth in relation to the anticipated costs associated with, among other things, its continuing research and development activities and the expansion of its sales and marketing activities, the Company expects to continue to incur net operating losses into the foreseeable future. Successful transition to attaining profitable operations is dependent upon gaining market acceptance of the Company’s products and achieving a level of revenues adequate to support the Company’s cost structure.
The accompanying condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern. The Company believes that existing cash resources will be sufficient to meet projected operating requirements for at least 12 months from the date of issuance of the accompanying condensed consolidated financial statements, however for the near future, the Company expects to continue to incur operating losses and negative cash flows. The Company plans to continue to fund its losses from operations using its cash, cash equivalents and short-term investments as of September 30, 2024 and meet its future capital funding needs through equity or debt financings, other third-party funding, collaborations, strategic alliances and licensing arrangements or a combination of these. If the Company raises additional funds by issuing equity securities, its stockholders may experience dilution. Any future debt financing into which the Company enters may impose additional covenants that restrict operations, including limitations on its ability to incur liens or additional debt, pay dividends, repurchase common stock, make certain investments or engage in certain merger, consolidation or asset sale transactions. Any debt financing or additional equity raise may contain terms that are not favorable to the Company or its stockholders. If the Company is required to enter into collaborations and other arrangements to address its liquidity needs, it may have to give up certain rights that limit its ability to develop and commercialize product candidates or may have other terms that are not favorable to the Company or its stockholders, which could materially and adversely affect its business and financial prospects. There can be no assurance that the Company will be able to obtain additional financing on acceptable terms, or at all. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible and/or suspend or curtail planned programs. Any of these actions could materially harm the Company’s business, results of operations and future prospects.
Note 2 - Summary of Accounting Policies
Use of Estimates
Thepreparation of consolidated financial statements in conformity with GAAP requires management to make informed estimates, judgments and assumptions that affect the reported amounts in the condensed consolidated financial statements and disclosures in the accompanying notes as of the date of the accompanying condensed consolidated financial statements. On an on-going basis, management evaluates the most critical estimates and assumptions for continued reasonableness. Actual results may differ materially from the estimates used in the preparationof the accompanying condensed consolidated financial statements under different assumptions or conditions.
Significant Accounting Policies
There have been no significant changes to the accounting policies during the three months ended September 30, 2024, as compared to the significant accounting policies described in Note 2 of the “Notes to Consolidated Financial Statements” in the Company’s audited consolidated financial statements included in its Annual Report on Form 10-K filed with the SEC on February 28, 2024.
Cash Equivalents
Cash equivalents consist of investments in money market accounts. The Company considers all highly liquid investments with original maturities of three months or less at the date of purchase that can be liquidated without prior notice or penalty to be cash equivalents.
Short-term Investments
Short-term investments are classified based on the maturity date of the related securities. Based on the nature of the assets, the Company’s short-term investments, which are government securities, are classified as available-for-sale and are recorded at their estimated fair value as determined by prices for identical or similar securities at the balance sheet date. The Company’s short-term investments consist of Level 2 financial instruments in the fair value hierarchy. Unrealized gains and losses are recorded as a component of Other Comprehensive Loss within Stockholders’ Equity on the condensed consolidated balance sheets. Realized gains and losses are included as other income (expense) in the accompanying Condensed Consolidated Statements of Operations and Comprehensive Loss. The cost basis for realized gains and losses on available-for-sale securities is determined on a specific identification basis. Management determines the appropriate classification of its investments at the time of purchase and reevaluates such determination at each balance sheet date. The Company periodically reviews its investments for unrealized losses other than credit losses and whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. In determining whether the carrying value is recoverable, management considers the following factors:
whether the investment has been in a continuous loss position for over 12 months;
the duration to maturity of investments;
intention and ability to hold the investment to maturity and if it is not more likely than not that the Company will be required to sell the investment before recovery of the amortized cost basis;
the credit rating, financial condition and near-term prospects of the issuer; and
the type of investments made.
The Company had $533,000 and $10,000 of net unrealized gains related to short-term investments as of September 30, 2024 and December 31, 2023, respectively.
Concentration of Credit Risk and Other Risks and Uncertainties
Financial instruments which potentially subject the Company to concentration of credit risk consist primarily of cash, cash equivalents, short-term investments and accounts receivable. The Company’s policy is to invest cash in institutional money market funds and marketable securities of the U.S. government to limit the amount of credit exposure. The Company currently maintains a portfolio of cash equivalents and short-term investments in money market funds and U.S. treasury bills. A portion of the Company's operating cash is held in accounts in excess of the Federal Deposit Insurance Corporation (“FDIC”) insurance limits; however, the Company has established guidelines regarding diversification of its investments and their maturities, which are designed to maintain principal and maximize liquidity. The Company has not experienced material losses on cash equivalents and short-term investments.
The Company’s products require approval from the FDA and foreign regulatory agencies before commercial sales can commence. There can be no assurance that the Company’s products will receive any of these required approvals. The denial or delay of such approvals may have a material adverse impact on the Company’s business and may impact business in the future. In addition, after approval by the FDA, there is still an ongoing risk of adverse events that did not appear during the device approval process.
The Company is subject to risks common to companies in the medical device industry, including, but not limited to, new technological innovations, clinical development risk, establishment of appropriate commercial partnerships, protection of proprietary technology, compliance with government and environmental regulations, uncertainty of market acceptance of the Company's products, product liability and the need to obtain additional financing.
The Company is subject to the risks related to global lead times, particularly in Europe and Asia, leading to a supply interruption from the Company's suppliers. In addition, the Company is currently experiencing inflation and longer lead times and limited availability in its supply chain for certain components and has continued exposure to price and supply risk related to anticipated purchases of certain commodities, materials and products used in its business.
Accounts Receivable, net
The Company has a diverse customer base and as of September 30, 2024 and December 31, 2023 the Company did not have any customers who individually accounted for greater than 10% of accounts receivable. The Company maintains an allowance for credit losses resulting from the inability of its customers, including ambulatory surgery centers, to make required payments. After evaluation of the collectability of accounts receivable, the Company didnot record any significant allowance for credit losses as of September 30, 2024 or December 31, 2023.
Fair Value of Financial Instruments
The Company uses fair value measurements to record fair value adjustments to certain assets and liabilities and to determine fair value disclosures. Fair value is measured as the price that would be received from the sale of an asset or paid to transfer a liability in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques that are consistent with the market, income or cost approach are used to measure fair value. The fair value hierarchy prioritizes the inputs to valuation techniques used to measure fair value into three levels:
Level 1—Observable inputs such as unadjusted quoted prices in active markets that are accessible at the measurement date for identical unrestricted assets or liabilities.
Level 2—Inputs (other than quoted prices included in Level 1) that are either directly or indirectly observable for the asset or liability, for substantially the full term of the asset or liability, through correlation with market data. These include quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and inputs to valuation models or other pricing methodologies that do not require significant judgment because the inputs used in the model, such as interest rates and volatility, can be corroborated by readily observable market data.
Level 3—One or more significant inputs that are unobservable and supported by little or no market activity and reflect the use of significant management judgment and assumptions. Level 3 assets and liabilities include those whose fair value measurements are determined using pricing models, discounted cash flow methodologies or similar valuation techniques and significant management judgment or estimation. These include the Black-Scholes option-pricing model which uses inputs such as expected volatility, risk-free interest rate and expected term to determine fair market valuation.
Assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurements. The Company reviews the fair value hierarchy classification at each reporting date. Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain assets or liabilities within the fair value hierarchy. The Company did not have any transfers of assets and liabilities between the levels of the fair value measurement hierarchy during the years presented.
The Company’s financial instruments consist principally of cash, cash equivalents, short-term investments, accounts receivable, accounts payable and operating lease liabilities. Cash, cash equivalents, accounts receivable and accounts payable are carried at their estimated fair value because of the short-term nature of these assets and liabilities. The Company’s short-term investments in government securities are carried at fair value, determined based on publicly available quoted market prices for identical securities at the measurement date. The Company believes the fair values of its operating lease liabilities at September 30, 2024 and December 31, 2023, approximated their carrying values, based on the borrowing rates that were available for loans with similar terms as of such date.
Inventories
Inventories consist of raw materials, work-in-process and finished goods. Raw materials are comprised of chemicals and parts used in the production of the Company's lenses, cartridges, and LDDs. Finished goods are comprised of lenses, cartridges, accessories and LDDs. Inventories are valued at the lower of cost or net realizable value. Cost is computed using standard cost, which approximates actual cost on a first-in, first-out basis. The carrying value of inventories is reviewed for potential impairment whenever indicators suggest that the cost of inventories exceeds the carrying value and management adjusts the inventories to its net realizable value. The cost of finished goods and work-in-process is comprised of raw materials, direct labor, other direct costs and related production overhead to the extent that these costs do not exceed the net realizable value of the goods produced. The Company periodically reviews inventories for potential impairment, estimated losses from obsolescence, material expirations or unmarketable inventories or excess inventories and writes down the cost of inventories to net realizable value at the time such determinations are made. Net realizable value is determined using the estimated selling price, in the ordinary course of business, less estimated costs to complete and dispose.
Leases
Lease right-of-use assets represent the Company’s right to use an underlying asset for the lease term, and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease right-of-use assets and liabilities are recognized when the Company takes possession of the leased property based on the present value of lease payments over the lease term. The Company estimates the incremental borrowing rate based upon the cost of its own debt financing, current market interest rates and quoted offerings or the rate implicit in the lease. Operating lease right-of-use assets also include any lease payments made at or before lease commencement and exclude any lease incentives received. The lease terms used to calculate the right-of-use asset and related lease liability include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Rent expense on noncancelable leases containing known future scheduled rent increases is recorded on a straight-line basis over the term of the respective leases beginning on the lease commencement date. The difference between rent expense and rent paid is accounted for as a component of operating lease right-of-use assets on the accompanying condensed consolidated balance sheets. Landlord improvement allowances and other such lease incentives are recorded as property and equipment and as reduction of the right-of-use leased assets and are amortized on a straight-line basis as a reduction to operating lease costs. Leases with an initial term of 12 months or less are expensed as incurred and are not recorded as right-of-use assets on the condensed consolidated balance sheets.
Net Loss per Share
Basic net loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average shares of common stock outstanding for the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average shares of common stock and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. Diluted net loss per share is calculated by dividing net loss by the weighted-average number of shares of common stock and potential dilutive securities outstanding during the period.
The following outstanding potentially dilutive securities were excluded from the calculation of diluted net loss per share attributable to common stockholders because their impact under the treasury stock method was anti-dilutive for the periods presented:
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Stock options issued and outstanding under the Calhoun Vision, Inc. 2006 Stock Plan, Calhoun Vision, Inc. 2015 Equity Incentive Plan and the 2021 Equity Incentive Plan | 5,294,813 | 6,963,498 | 5,658,989 | 5,816,203 |
| Restricted stock units issued under the 2021 Equity Incentive Plan | 644,073 | 730,419 | 649,842 | 696,696 |
| Stock issuable in offering period under the 2021 Employee Stock Purchase Plan | 20,670 | 35,878 | 63,756 | 42,020 |
Revenue Recognition
The Company’s revenue is generated from the sale of LALs used in cataract surgery along with a specifically designed machine for delivering light to the eye, the LDD, to adjust the lens post-surgery, as needed. Revenue is recognized from sales of products in the U.S., Canada and Europe. Customers are primarily comprised of ambulatory surgery centers, hospitals, and physician private practices.
The Company recognizes revenues when promised goods or services are transferred to customers at a transaction price that reflects the consideration to which the Company expects to be entitled in exchange for those goods and services. Specifically, the Company applies the following five steps to recognize revenue: (i) identify the contract(s) 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 a performance obligation. The Company applies the five-step model to contracts when it is probable that it will collect the consideration to which it is entitled in exchange for the goods or services it transfers to the customer. At contract inception, the Company assesses the goods promised within each customer contract to determine the individual deliverables in its product offerings as separate performance obligations and assesses whether each promised good or service is distinct. The transaction price is determined based on the consideration expected to be received, based either on the stated value in contractual arrangements or the estimated cash to be collected in non-contracted arrangements. The Company recognizes revenue as the amount of the transaction price that is allocated to the respective performance obligation when, or as, the performance obligation is satisfied, considering whether or not this occurs at a point in time or over time. The Company elected to account for shipping costs as fulfillment costs rather than a promised service and excludes from revenue any taxes collected from customers that are remitted to government authorities.
The Company’s LDD contracts contain multiple performance obligations bundled for one transaction price, with all obligations generally satisfied within one year. For these bundled arrangements, the Company accounts for individual products and services as separate performance obligations if they are distinct, that is, if a product or service is separately identifiable from other items in the bundled package, and if a customer can benefit from it on its own or with other resources that are readily available to the customer. The Company’s LDD contracts include a combination of the following performance obligations: (i) LDD capital asset and related components, (ii) training and (iii) device service (initial year). Each of these three performance obligations are considered distinct. The LDD capital asset is distinct because the customer can benefit from it together with other resources that are readily available to the customer. Training on the use of the machine is offered as a distinct activity after installation of the LDD to enhance the customer’s ability to utilize the machine by having an industry professional provide best practices and customize training to the specific needs of the customer. Each LDD comes with a twelve-month manufacturer’s warranty (service-type) that includes preventative maintenance, unscheduled service (labor and parts) and software updates. After the first year, service contracts can be purchased separately on a standalone basis. The Company recognizes revenue as performance obligations are satisfied by transferring control of the product or service to a customer. Specifically, revenue for the LDD capital asset is recognized at a point in time at installation. Revenue for training is also recorded at a point in time, generally 60 days after installation. Revenue for the device service is recognized ratably over time after installation, generally 12 months. The Company has determined that the transaction price is the invoice price, net of adjustments, if any. The allocation to the separate performance obligations is based upon the relative standalone selling price. Standalone selling prices are based on observable prices at which the Company separately sells the products or services. The Company estimates the standalone selling price using the market assessment approach considering market conditions and entity-specific factors including, but not limited to, features and functionality of the products and services, geographies, type of customer and market conditions. The Company regularly reviews and updates standalone selling prices as necessary.
LALs are generally held at customer sites on consignment. The single performance obligation is satisfied, and revenue from sales is recognized for LALs upon customer notification that the LALs have been implanted in a patient. For the three and nine months ended September 30, 2024 and 2023, credits related to returns and rebates on list prices were not significant.
The Company has adopted the practical expedient permitting the direct expensing of costs incurred to obtain contracts where the amortization of such costs would occur over one year or less, and it applied to substantially all the Company’s contracts. Revenue for service agreements is recognized ratably over the term of each contract.
For thethree and nine months ended September 30, 2024 and 2023, revenue from contracts with customers consisted of the following (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| LDD (including training) | $10,128 | $7,932 | $29,030 | $22,127 |
| LAL | 24,231 | 13,502 | 67,975 | 36,308 |
| Service warranty, service contracts, and accessories | 955 | 765 | 2,708 | 2,062 |
| $35,314 | $22,199 | $99,713 | $60,497 | |
For the three and nine months ended September 30, 2024 and 2023, the Company did not have any customers who individually accounted for greater than 10% of revenue.
The following table represents the contract liabilities from sales activity for thenine months ended September 30, 2024 and 2023, respectively (in thousands):
| Nine Months Ended September 30, | ||
|---|---|---|
| 2024 | 2023 | |
| Balance at beginning of period | $1,888 | $1,187 |
| Additions during the period | 3,301 | 2,427 |
| Revenue recognized during the period | (2,626) | (1,936) |
| Balance at end of period | $2,563 | $1,678 |
Stock-Based Compensation
The Company has three equity incentive compensation plans: the Calhoun Vision, Inc. 2006 Stock Plan (“2006 Plan”); the Calhoun Vision, Inc. 2015 Equity Incentive Plan (“2015 Plan”); and the 2021 Equity Incentive Plan (“2021 Plan”), which are collectively referred to as the “Equity Plans.” The Company also has an employee stock purchase plan, the 2021 Employee Stock Purchase Plan (“2021 ESPP”).
The Company recognizes compensation expense for equity-based awards on the date of grant to employees, board of directors and consultants based on the estimated grant date fair value of the award's equity-based payments including stock options, restricted stock units and employee stock plan purchases. The fair value of the option awards are estimated using the Black-Scholes option-pricing model and recognized as an expense in the condensed consolidated statements of operations and comprehensive loss over the requisite service period, which is generally four years. The Company amortizes the stock-based compensation for equity awards with service conditions on a straight-line basis over the vesting period of the awards. Forfeitures of unvested stock option awards are recognized as reductions of expense as they occur.
The Black-Scholes option-pricing model requires the use of assumptions about a number of variables, such as the fair market value of the Company’s common stock, expected volatility, expected term, risk-free interest rate, and dividend yield as discussed below:
Fair market value—The fair value of common stock is determined by using the closing price per share of common stock as reported on the Nasdaq Global Market.
Expected volatility—Effective January 1, 2024, the Company based the expected volatility on the historic volatility of its common stock. During the year ended December 31, 2023, the expected volatility was estimated based on the average historical volatilities for comparable publicly traded medical device companies over a period equal to the expected term of the stock option grants. Comparable companies were chosen based on their similar size, stage in the life cycle and area of specialty.
Expected term—The Company’s expected term represents the period that the Company’s stock-based awards are expected to be outstanding. The Company used the simplified method (based on the mid-point between the vesting date and the end of the contractual term) to determine the expected term.
Risk-free interest rate—The risk-free interest rate used is based on the published U.S. Department of Treasury interest rates in effect at the time of stock option grant for zero coupon U.S. Treasury notes with maturities approximating each grant’s expected term.
Dividend yield—The Company has never paid dividends on its common stock and has no plans to pay dividends on its common stock. Therefore, the Company used an expected dividend yield of zero.
Recent Accounting Pronouncements
Changes to GAAP are established by the Financial Accounting Standards Board (“FASB”) in the form of accounting standards updates (“ASU”). There have been no recent accounting pronouncements, changes in accounting pronouncements or recently adopted accounting guidance during the three months ended September 30, 2024 that are of significance or potential significance to the Company.
Note 3 – Short-Term Investments
Short-term investments, principally U.S. Treasury bills, are available-for-sale and consisted of the following (in thousands):
| Amortized Cost | Unrealized Gain, Net | Estimated Fair Value | |
|---|---|---|---|
| U.S. Treasury securities | $219,867 | $533 | $220,400 |
| Amortized Cost | Unrealized Gain, Net | Estimated Fair Value | |
|---|---|---|---|
| U.S. Treasury securities | $117,480 | $10 | $117,490 |
All available-for-sale securities held as of September 30, 2024 and December 31, 2023 had a maturity of less thanone year. The Company has classified all marketable securities, regardless of maturity, as short-term investments based upon the Company’s ability and intent to use any and all of those marketable securities to satisfy the Company’s liquidity requirements.
Note 4 – Inventories
Inventories consisted of the following (in thousands):
| September 30, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| Finished goods | $12,887 | $8,092 |
| Raw materials | 5,837 | 5,680 |
| Work-in-process | 3,567 | 4,145 |
| 22,291 | 17,917 | |
| Less: reserve for excess and obsolete inventory | (618) | (496) |
| $21,673 | $17,421 |
At September 30, 2024 and December 31, 2023, finished goods included$5.2 million and$4.4 million of inventory held on consignment at customer sites, respectively.
Note 5 – Fair Value Measurements
The table and disclosures for the periods presented below (in thousands) present the Company’s assets and liabilities measured at fair value on a recurring basis and indicate the fair value hierarchy of the valuation techniques utilized by the Company to determine such fair value. The Company did not have any assets or liabilities measured at fair value on a recurring basis within Level 3 fair value measurements.
| Level I | Level II | Total | |
|---|---|---|---|
| Assets: | |||
| Money market securities | $6,967 | — | $6,967 |
| U.S. Treasury securities | — | 220,400 | 220,400 |
| Total assets at fair value | $6,967 | $220,400 | $227,367 |
| Level I | Level II | Total | |
|---|---|---|---|
| Assets: | |||
| Money market securities | $4,475 | — | $4,475 |
| U.S. Treasury securities | — | 117,490 | 117,490 |
| Total assets at fair value | $4,475 | $117,490 | $121,965 |
Note 6 – Stock-Based Compensation Expense
The Company has three equity incentive compensation plans: the 2006 Plan, the 2015 Plan and the 2021 Plan.
2006 Plan
The 2006 Plan was originally adopted by the Board and approved by the Company’s stockholders in 2006. The 2006 Plan was terminated in 2015 in connection with the adoption of the 2015 Plan and as a result no new awards may be issued under the 2006 Plan. However, the 2006 Plan will continue to govern the terms and conditions of the outstanding awards previously granted under the 2006 Plan.
2015 Plan
The 2015 Plan was originally adopted by the Board and approved by the Company’s stockholders in 2015. In July 2021, the 2015 Plan terminated immediately prior to effectiveness of the 2021 Plan with respect to the grant of future awards. However, the 2015 Plan will continue to govern the terms and conditions of the outstanding awards previously granted under the 2015 Plan.
2021 Plan
On July 28, 2021, the 2021 Plan was adopted and approved by the Board and stockholders. The 2021 Plan provides for the grant of incentive stock options to employees and any subsidiary corporations’ employees, and for thegrant of nonstatutory stock options, stock appreciation rights, restricted stock, restricted stock units (“RSUs”), and performance awards to employees, directors, and consultants and subsidiary corporations’ employees and consultants. The number of shares of the Company’s common stock originally available for issuance under the 2021 Plan was equal to 2,420,135 shares of common stock plus any shares subject to awards granted under the 2015 Plan and the 2006 Plan that, after the effectiveness of the 2021 Plan, expire or otherwise terminate without having been exercised in full, are tendered to or withheld by the Company for payment of an exercise price or for tax withholding obligations, or are forfeited to or repurchased by the Company due to failure to vest, with the maximum number of shares to be added to the 2021 Plan from the 2015 Plan and 2006 Plan equal to 4,569,530 shares of common stock.
Evergreen provision
The number of common shares reserved for issuance under the 2021 Plan will be increased automatically on the first day of each fiscal year beginning with the 2022 fiscal year and ending on the ten year anniversary of the date the Board approved the 2021 Plan, by a number equal to the least of: (i)7,260,406 shares of our common stock; (ii)4% of the outstanding shares of our common stock on the last day of the immediately preceding fiscal year; or (iii) such lesser number of shares of our common stock as the administrator may determine. The 2021 Plan is administered by the Board. On January 1, 2024 and 2023, the number of shares available under the 2021 Plan increased by 1,445,580 and 1,130,735 shares of common stock, respectively, pursuant to this feature. As of September 30, 2024, the number of shares of the Company’s common stock available for future issuance under the 2021 Plan was equal to 599,452 shares of common stock.
2021 ESPP
On July 28, 2021, the Board and stockholders adopted and approved the 2021 ESPP. As of September 30, 2024, the number of shares of the Company’s common stock available for future issuance under the 2021 ESPP was equal to 538,942 shares of common stock.
The 2021 ESPP provides eligible employees of the Company and its subsidiaries with the opportunity to purchase shares of the Company’s common stock at a purchase price equal to 85% of the common stock’s fair market value on the first trading day or last trading day of each purchase period, whichever is lower. The 2021 ESPP provides for two six-month purchase periods every twelve months: May 1 through October 31 and November 1 through April 30. The initial purchase period began on November 1, 2021.
Evergreen provision
The number of common shares reserved for issuance under the 2021 ESPP will be increased automatically on the first day of each fiscal year beginning with the 2022 fiscal year, by a number equal to the least of: (i)1,452,081 shares; (ii)1% of the outstanding shares of our common stock on the last day of the immediately preceding fiscal year; or (iii) such other amount as the administrator may determine. The 2021 ESPP is administered by the Board. No additional shares were reserved for issuance on January 1, 2024 and 2023 pursuant to this feature.
Stock-Based Compensation Expense
The purpose of the 2021 Plan and 2021 ESPP is to provide a means by which eligible recipients of stock awards may be given an opportunity to benefit from increases in the value of the common stock in order to retain or procure the services of the employees, members of the Board and consultants and provide them with an incentive to promote the Company’s success and accomplish corporate goals.
Stock option awards are granted with an exercise price of no less than 100% of estimated fair market value on the date of grant. Time based awards generally vest over four years as follows, subject to the optionee’s continuing service: (i) one fourth of the total number of shares vest and become exercisable on the one-year anniversary and then 1/48th of the total number of shares subject to the option vest and become exercisable on each monthly anniversary thereafter for the remaining three years, or (ii) 1/48th of the total number of shares subject to the option vest and become exercisable each month over four years.
A summary of the stock option activities related to the Equity Plans for thenine months ended September 30, 2024 is presented below:
| Number of Options | WeightedAverageExercisePrice | Weighted AvgRemainingContractual Life(Years) | |
|---|---|---|---|
| Options outstanding as of December 31, 2023 | 6,777,404 | $13.02 | 6.51 |
| Granted | 1,147,452 | 53.00 | |
| Exercised | (1,809,836) | 9.44 | |
| Forfeited | (82,972) | 17.34 | |
| Expired | (10,251) | 4.65 | |
| Options outstanding as of September 30, 2024 | 6,021,797 | 21.66 | 7.13 |
| Exercisable as of September 30, 2024 | 3,390,946 | $15.10 | 5.98 |
As of September 30, 2024 and December 31, 2023 the intrinsic value of options vested was $117.0 million and $121.3 million, respectively, and of all options outstanding was $172.4 million and $185.0 million, respectively. During thenine months ended September 30, 2024 and 2023, the total cash received from the exercise of stock options was $17.1 million and $5.4 million, respectively. The total fair value less strike price of these options was $75.1 million and $8.4 million, respectively.
A summary of non-vested restricted stock unit activities for thenine months ended September 30, 2024 is as follows:
| Weighted | ||
|---|---|---|
| Average | ||
| Number of | Grant Date | |
| Shares | Fair Value | |
| Unvested at December 31, 2023 | 650,357 | $15.80 |
| Granted | 263,481 | 53.28 |
| Vested | (298,094) | 19.56 |
| Forfeited | (27,158) | 17.47 |
| Unvested at September 30, 2024 | 588,586 | $30.60 |
Stock-based compensation expense was classified in the accompanying condensed consolidated statements of operations and comprehensive income (loss) as follows (in thousands):
| Three Months Ended September 30, | Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Research and development | $1,559 | $1,035 | $4,060 | $2,857 |
| Selling, general and administrative | 4,446 | 2,731 | 11,856 | 7,642 |
| Cost of sales | 547 | 305 | 1,437 | 822 |
| $6,552 | $4,071 | $17,353 | $11,321 | |
As of September 30, 2024 and December 31, 2023, there were 2,630,851 and 2,539,445 unvested options, respectively. As of September 30, 2024 and December 31, 2023, total unrecognized expense related to unvested stock options was approximately $49.7 million and $22.7 million, respectively. Both amounts are expected to be recognized over a weighted average period of approximately 2.5 and 2.4 years, respectively.
As of September 30, 2024, and December 31, 2023, total unrecognized expense related to non-vested restricted stock units was approximately $17.0 million and $8.3 million, respectively. The unrecognized compensation cost is expected to be recognized over a weighted average period of 2.4 years and 2.3 years, respectively.
The following table presents the range and weighted-average assumptions, used in the Black-Scholes option pricing model to determine the fair value of stock options:
| Nine Months Ended September 30, | ||||
|---|---|---|---|---|
| 2024 | 2023 | |||
| Range | Weighted Average | Range | Weighted Average | |
| Expected volatility | 67.8% to 72.3% | 70.4% | 64.9% to 67.7% | 65.3% |
| Risk-free interest rate | 3.5% to 4.7% | 4.1% | 3.4% to 4.6% | 4.1% |
| Expected life (in years) | 6.0 to 6.1 years | 6.0 years | 5.5 to 6.1 years | 6.1 years |
| Expected dividend yield | 0.0% | 0.0% | 0.0% | 0.0% |
| Grant date fair value | $36.89 to $60.65 | $53.45 | $12.91 to $32.45 | $16.89 |
Common Stock
Each share of common stock is entitled to one vote. Common stock reserved for future issuance consisted of the following:
| September 30, 2024 | December 31, 2023 | |
|---|---|---|
| Stock options issued and outstanding under the Equity Plans | 6,021,797 | 6,777,404 |
| Shares available for future issuance under the 2021 Plan | 599,452 | 358,610 |
| Restricted stock units issued under the 2021 Plan | 588,586 | 650,357 |
| Shares available for future issuance under 2021 ESPP | 538,942 | 577,847 |
| Total shares of common stock reserved | 7,748,777 | 8,364,218 |
Note 7 – Leases
The Company has operating and finance leases for facilities and certain equipment. Leases with an initial term of 12 months or less are not recorded on the condensed consolidated balance sheets. Lease expense for operating leases is recognized on a straight-line basis over the lease term. The Company does not combine lease and non-lease components in the recognition of lease expense.
As of September 30, 2024 the Company held four leases for office, manufacturing and warehouse facilities in Aliso Viejo, California. The four leases are for approximately 137,000 square feet in the aggregate. For one such operating lease, the lessor provided $900,000 in tenant allowances.
On April 4, 2022, the Company entered into athirty-four-month sublease agreement for a portion of the 5 Columbia Building, in Aliso Viejo, CA. The sublease commencement date was June 13, 2022 and was to expire on March 31, 2025. The base rent receivable was $11,410 per month. On January 4, 2023 the Company entered into a second amendment to the sublease agreement adjusting the base rent receivable to $5,319 per month. On August 1, 2024 the sublease was cancelled.
New lease and lease amendments
100 Columbia lease to include 120 Columbia Suites 300, 400 and 500
On November 6, 2024, the Company entered into a Seventh Amendment (Extension to the Lease) to that certain Commercial Lease Agreement, dated August 31, 2015, as amended June 3, 2024, as amended April 18, 2024, as amended November 23, 2015, December 22, 2015, January 18, 2016, and November 12, 2016, with Accuride International Inc., to expand the 100 Columbia lease to include the property located at 120 Columbia Suites 300, 400 and 500 for a total of approximately 13,183 additional leasable square feet in Aliso Viejo, California (the “November 2024 120 Columbia Amendment”). Pursuant to the November 2024 120 Columbia Amendment, the term of the lease is 74 months, beginning on December 1, 2024 and ending on January 31, 2031. The parties agreed to the base rent rate payable over the 74 month term as set forth in the November 2024 120 Columbia Amendment. The base rent is initially $22,016 per month and includes fixed rent escalations beginning on December 1, 2025. The Company has two options to extend the term of the lease at the end of the current term, with each option to extend being for a 5 year term. The lessor provided $150,000 in tenant allowances. Under the lease agreement, the Company is required to pay approximately $1.8 million in future minimum lease payments of which $22,000 thousand will be paid in 2024, $0.3 million will be paid in each year during 2025, 2026, 2027 and 2028, and $0.6 million will be paid thereafter.
100 Columbia
On April 18, 2024, the Company entered into a Fifth Amendment to that certain Commercial Lease Agreement, dated August 31, 2015, as amended November 23, 2015, December 22, 2015, January 18, 2016, and November 12, 2016, with Accuride International Inc., for an approximately 42,106 square foot industrial facility located at 100 Columbia in Aliso Viejo, California (the “April 2024 100 Columbia Amendment”). Pursuant to the April 2024 100 Columbia Amendment, the term of the lease was extended 76 months, beginning on October 1, 2024 and ending on January 31, 2031. The parties agreed to the base rent rate payable over the 76 month term as set forth in the April 2024 100 Columbia Amendment. The base rent is initially $64,843 per month and includes fixed rent escalations beginning on October 1, 2025. The Company has two options to extend the term of the lease at the end of the current term, with each option to extend being for a 5 year term. The lessor provided $50,000 in tenant allowances.
On June 3, 2024, the Company entered into a Sixth Amendment to that certain Commercial Lease Agreement, dated August 31, 2015, as amended April 18, 2024 as amended November 23, 2015, December 22, 2015, January 18, 2016, and November 12, 2016, with Accuride International Inc., for the property located at 100 Columbia in Aliso Viejo, California (the “June 2024 100 Columbia Amendment”). The June 2024 100 Columbia Amendment updated certain notification requirements.
125 Columbia
On April 18, 2024, the Company entered into a Standard Industrial/Commercial Single-Tenant Lease – Net (the “125 Columbia Lease”) with BML Management, LLC, for an approximately 26,825 square foot industrial and research and development facility in Aliso Viejo, California. The 125 Columbia Lease commences on June 1, 2024 and will end on January 31, 2031. The Company has two options to extend the term of the 125 Columbia Lease, with each option to extend being for a term of 60 months, commencing when the prior term expires. The base rent is initially $41,579 per month, payable on the first day of each month commencing on June 1, 2024, subject to adjustment as set forth in the 125 Columbia Lease.
5 Columbia
On April 18, 2024 and June 3, 2024, the Company entered into Lease Amendment #2 and Lease Amendment #3, respectively to that certain Lease Agreement dated January 10, 2018, as amended on April 5, 2022, with Clifford D. Downs, for an approximately 19,680 square foot industrial facility located at 5 Columbia in Aliso Viejo, California (collectively the “5 Columbia Amendments”). Pursuant to the 5 Columbia Amendments, the term of the lease was extended 70 months, beginning on April 1, 2025 and ending on January 31, 2031. The parties agreed to the base rent rate payable over the 70 month term as set forth in the 5 Columbia Amendments. The base rent is initially $30,701 per month and includes fixed rent escalations beginning on April 1, 2027. The Company has two options to extend the term of the lease, with each option to extend being for a term of 60 months, commencing when the prior term expires.
The following table presents the lease balances within the Condensed Consolidated Balance Sheets as of September 30, 2024 and December 31, 2023 (in thousands):
| September 30, · December 31, | |||
|---|---|---|---|
| Leases | Classification | 2024 | 2023 |
| Assets | |||
| Operating | Operating leases right-of-use assets | $10,536 | $2,444 |
| Finance | Property and equipment, net | 134 | 156 |
| Total lease assets | 10,670 | 2,600 | |
| Liabilities | |||
| Current | |||
| Operating | Lease liabilities | 707 | 1,764 |
| Finance | Lease liabilities | 27 | 37 |
| Noncurrent | |||
| Operating | Long-term lease liabilities | 10,456 | 1,093 |
| Finance | Long-term lease liabilities | 114 | 118 |
| Total lease liabilities | $11,304 | $3,012 | |
For thethree and nine months ended September 30, 2024 and 2023, the components of operating and finance lease expenses were as follows (in thousands):
| Three Months Ended September 30, · Nine Months Ended September 30, | |||||
|---|---|---|---|---|---|
| Lease Cost | Classification | 2024 | 2023 | 2024 | 2023 |
| Operating lease cost | Cost of sales | $3 | $3 | $9 | $10 |
| Research and development | 24 | 20 | 72 | 81 | |
| Selling, general and administrative | 673 | 440 | 1,700 | 1,326 | |
| Finance lease cost | Research and development | — | 29 | 17 | 92 |
| Selling, general and administrative | 8 | 9 | 23 | 27 | |
| Finance lease cost | Interest expense | 5 | 2 | 16 | 8 |
Maturities of the Company’s operating and finance lease liabilities as of September 30, 2024 were as follows (in thousands):
| Operating · Finance | ||
|---|---|---|
| Year Ended December 31, | Leases | Leases |
| 2024 (remainder) | $500 | $11 |
| 2025 | 2,434 | 46 |
| 2026 | 2,637 | 46 |
| 2027 | 2,782 | 46 |
| 2028 | 2,871 | 39 |
| 2029 | 2,954 | — |
| Thereafter | 3,307 | — |
| Total lease payments | 17,485 | 188 |
| Less: imputed interest | (6,322) | (47) |
| Total lease liabilities | $11,163 | $141 |
The weighted average remaining lease term and weighted average discount rate used to determine lease liabilities related to the Company’s operating and finance leases as of September 30, 2024 and December 31, 2023 were:
| September 30, | December 31, | |
|---|---|---|
| Lease Term and Discount Rate | 2024 | 2023 |
| Weighted average remaining lease term (years) | ||
| Operating leases | 6.33 | 1.69 |
| Finance leases | 4.10 | 4.37 |
| Weighted average discount rate | ||
| Operating leases | 14.4% | 10.4% |
| Finance leases | 14.4% | 14.0% |
Note 8 – Commitments and Contingencies
Letter of credit
The Company's standby letter of credit was not required to be renewed and expired on September 30, 2024.
Legal Matters
From time-to-time, the Company may be involved in certain legal proceedings or regulatory matters arising in the ordinary course of business, including without limitation, actions with respect to intellectual property, employment, regulatory, product liability and contractual matters. In connection with these proceedings or matters, the Company regularly assesses the probability and amount (or range) of possible issues based on the developments in these proceedings or matters. A liability is recorded in the consolidated financial statements if it is determined that it is probable that a loss has been incurred, and that the amount (or range) of the loss can be reasonably estimated. Because of the uncertainties related to any pending proceedings or matters, the Company is currently unable to predict their ultimate outcome and, with respect to any legal proceeding or regulatory matter where no liability has been accrued, to make a reasonable estimate of the possible loss (or range of loss) that could result from an adverse outcome. At September 30, 2024 and December 31, 2023, there wereno legal proceedings, regulatory matters, or other disputes or claims for which a material loss was considered probable or for which the amount (or range) of loss was reasonably estimable. However, regardless of the outcome, legal proceedings, regulatory matters, and other disputes and claims can have an adverse impact on the Company because of legal costs, diversion of management time and resources, and other factors.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.