Stereotaxis, Inc.
For the period ended Dec 31, 2024. Filed Mar 14, 2025.
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FY2024 · Filed Mar 14, 2025
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Notes to the Consolidated Financial Statements
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
Notes to Consolidated Financial Statements
In this report, “Stereotaxis”, the “Company”, “Registrant”, “we”, “us”, and “our” refer to Stereotaxis, Inc. and its wholly owned subsidiaries. GenesisX RMN, Genesis RMN®, Niobe®, Navigant®, Synchrony, SynX, Odyssey®, Odyssey Cinema™, MAGiC ™, EMAGIN, Map-iT™, QuikCAS™, Cardiodrive®, Vdrive®, Vdrive Duo™, V-CAS™, V-Loop™, V-Sono™, and NuVizion are trademarks of Stereotaxis, Inc. All other trademarks that appear in this report are the property of their respective owners.
1. Description of Business
Stereotaxis designs, manufactures and markets robotic systems, instruments and information systems for the interventional laboratory. Our proprietary robotic technology, Robotic Magnetic Navigation, fundamentally transforms endovascular interventions using precise computer-controlled magnetic fields to directly control the tip of flexible interventional catheters or devices. Direct control of the tip of an interventional device, in contrast to all manual hand-held devices that are controlled from their handle, can improve the precision, stability, reach and safety of these devices during procedures.
Our primary clinical focus has been electrophysiology, specifically cardiac ablation procedures for the treatment of arrhythmias. Cardiac ablation has become a well-accepted therapy for arrhythmias and a multi-billion-dollar medical device market with expectations for substantial long-term growth. We have shared our aspiration and a product strategy to expand the clinical focus of our technology to several additional endovascular indications including coronary, neuro, and peripheral interventions.
There is substantial real-world evidence and clinical literature for Robotic Magnetic Navigation in electrophysiology. Hundreds of electrophysiologists at over one hundred hospitals globally have treated over 150,000 arrhythmia patients with our robotic technology. Clinical use of our technology has been documented in over 500 clinical publications. Robotic Magnetic Navigation is designed to enable physicians to complete more complex interventional procedures with greater success and safety by providing image-guided delivery of catheters through the blood vessels and chambers of the heart to treatment sites. This is achieved using externally applied computer-controlled magnetic fields that govern the motion of the working tip of the catheter, resulting in improved navigation. The more flexible atraumatic design of catheters driven using magnetic fields may reduce the risk of patient harm and other adverse events. Performing the procedure from a control cockpit enables physicians to complete procedures in a safe location protected from x-ray exposure, with greater ergonomics, and improved efficiency. We believe these benefits can be applicable in other endovascular indications where navigation through complex vasculature is often challenging or unsuccessful and generates significant x-ray exposure.
Our primary products include theGenesis RMNSystem, theGenesisX RMN System, theOdysseySolution, and other related devices. Through our strategic relationships with fluoroscopy system manufacturers, providers of catheters and electrophysiology mapping systems, and other parties, we offer our customers x-ray systems and other accessory devices.
TheGenesis RMN System is designed to enable physicians to complete more complex interventional procedures by providing image-guided delivery of catheters through the blood vessels and chambers of the heart to treatment sites. This is achieved using externally applied magnetic fields that govern the motion of the working tip of the catheter, resulting in improved navigation, efficient procedures, and reduced x-ray exposure. The*GenesisX RMN System,*the latest generation of the Genesis RMN System, is designed to significantly enhance the accessibility of Robotic Magnetic Navigation by eliminating the lengthy construction cycle necessary to install prior generation RMN systems.
TheOdyssey Solution consolidates lab information onto one large integrated display, enabling physicians to view and control all the key information in the operating room. This is designed to improve lab layout and procedure efficiency. The system also features a remote viewing and recording capability calledOdyssey Cinema, which is an innovative solution that delivers synchronized content for optimized workflow, advanced care, and improved productivity. This tool includes an archiving capability that allows clinicians to store and replay entire procedures or segments of procedures. This information can be accessed from locations throughout the hospital local area network and over the global Odyssey Network providing physicians with a tool for clinical collaboration, remote consultation, and training. We are actively developing the next generation imaging and collaboration solutions withSynchrony andSynX.
We pursue arrangements with fluoroscopy system manufacturers to provide such systems in a bundled purchase offer for hospitals establishing robotic interventional operating rooms. An integrated x-ray system is critical for customer adoption of RMN systems, and when offered as a bundled purchase offer with the RMN System, may reduce the cost of acquisition, the ongoing cost of ownership, and the complexity of installation of a robotic electrophysiology practice.
We promote our full suite of products necessary for a typical hospital implementation, subject to regulatory approvals or clearances. This implementation requires a hospital to agree to an upfront capital payment and recurring payments. The upfront capital payment typically includes equipment and installation charges. The recurring payments typically include disposable costs for each procedure, equipment service costs beyond the warranty period, and ongoing software updates. In hospitals where our full suite of products has not been implemented, equipment upgrade or expansion can be implemented upon purchasing of the necessary upgrade or expansion.
We have received regulatory clearances and approvals necessary for us to market theGenesis RMN System in the U.S., Europe, and China, and we are in the process of obtaining necessary registrations for extending our markets in other countries. TheGenesisX RMN System,the latest generation of the Genesis RMN System has received regulatory clearances and approvals in Europe, and we are in the process of obtaining necessary registrations in the US and other countries, TheNiobe System, our prior generation robotic magnetic navigation system, theOdyssey Solution,Cardiodrive, e-Contact, and various disposable interventional devices, including the Map-iT family of devices, have received regulatory clearances and approvals in the U.S., Europe, Canada, China, Japan and various other countries. We have regulatory clearances and approvals that allow us to market theVdrive andVdrive Duo Systems with theV-CASdevice in the U.S., Canada, and Europe. We have obtained the CE marking for us to market the Stereotaxis MAGiC catheter, a robotically-navigated magnetic ablation catheter, designed to perform minimally invasive cardiac ablation procedures, in Europe, and are pursuing regulatory approvals for the MAGiC catheter in the U.S. and other global geographies. Approval processes can be lengthy and uncertain, submissions may require revised or additional non-clinical and clinical data, and regulatory applications could be denied.
We have strategic relationships with technology leaders and innovators in the global interventional market. Through these strategic relationships we provide compatibility with our robotic magnetic navigation system, integrated x-ray systems, digital imaging and 3D catheter location sensing technology, and compatible disposable interventional devices. The maintenance of these strategic relationships, or the establishment of equivalent alternatives, is critical to our commercialization efforts. There are no guarantees that any existing strategic relationships will continue, and efforts are ongoing to ensure the availability of compatible systems and devices and/or equivalent alternatives. We cannot provide assurance as to the timeline of the ongoing availability of such compatible systems or our ability to obtain equivalent alternatives on competitive terms or at all.
On July 31, 2024, the Company completed its acquisition of all the shares of capital stock of Access Point Technologies EP, Inc., a Minnesota corporation (“APT”), from APT Holding Company, Inc., a Minnesota corporation. APT, based in Rogers, Minnesota, designs, manufactures, and commercializes a portfolio of differentiated high-quality diagnostic catheters, branded as Map-iT catheters, used during cardiac ablation procedures that are commercially available across key global geographies.
The integration with APT provides in-house catheter development, manufacturing expertise and specialized knowledge that will further Stereotaxis’ innovation efforts in developing a broad family of interventional devices navigated by our robots within electrophysiology and across a range of endovascular procedures.
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany balances and transactions are eliminated in consolidation.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to concentration of credit risk consist of cash, cash equivalents and marketable securities. Our investments may include, at any time, a diversified portfolio of cash equivalents and short-term and long-term investments in a variety of high-quality securities, including money market funds, U.S. treasury and U.S. government agency securities, corporate notes and bonds, commercial paper, non-U.S. government agency securities, and municipal notes. The Company’s exposure to any individual corporate entity is limited by policy. Deposits may exceed federally insured limits, and the Company is exposed to credit risk on deposits in the event of default by the financial institutions to the extent account balances exceed the amount insured by the Federal Deposit Insurance Corporation (FDIC). The Company closely monitors events involving limited liquidity, defaults, non-performance or other adverse developments that affect financial institutions or other companies in the financial services industry or the financial services industry generally, including Silicon Valley Bank. On March 10, 2023, Silicon Valley Bank (“SVB”), where the Company maintained accounts with a cash balance of less than 6% of the Company’s total cash, cash equivalents and marketable securities, was closed by the California Department of Financial Protection and Innovation and the FDIC was appointed as receiver. On March 12, 2023, the U.S. Department of the Treasury, Federal Reserve Board, and FDIC released a joint statement announcing that the FDIC would complete its resolution of SVB in a manner that fully protected all depositors at SVB and that depositors would have access to all of their money starting March 13, 2023. On March 26, 2023, it was announced that First-Citizens Bank & Trust Company would assume all of SVB’s deposits and loans as of March 27, 2023. During the periods presented, the Company has not experienced any losses on its deposits of cash, cash equivalents or marketable securities.
Cash and Cash Equivalents
Cash and cash equivalents include cash on hand, money market instruments, and other highly liquid investments with original maturities of three months or less from the date of purchase.
Restricted Cash
Restricted cash primarily consists of cash that the Company is obligated to maintain in accordance with contractual obligations.
Investments
Our investments may include, at any time, a diversified portfolio of cash equivalents and short-and long-term investments in a variety of high-quality securities, including money market funds, U.S. treasury and U.S. government agency securities, corporate notes and bonds, commercial paper, non-U.S. government agency securities, and municipal notes. As of December 31, 2024 and 2023, the Company hadno short-term investments.
Amortized cost of U.S. treasury securities and marketable debt securities are based on the Company’s purchase price adjusted for accrual of discount, or amortization of premium, and recognition of impairment charges, if any. The amortized cost of securities the Company purchases at a discount or premium will equal the face or par value at maturity or the call date, if applicable. Stated interest on investments is reported as income when earned and is adjusted for amortization or accretion of any premium or discount. Accrued interest receivable on investments, included in other current assets was less than $0.1 million as of December 31, 2024, and 2023.
Fair Value Measurements
Financial instruments consist of cash and cash equivalents, restricted cash, investments, accounts receivable, and accounts payable.
The Company measures certain financial assets and liabilities at fair value on a recurring basis. General accounting principles for fair value measurement establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets and liabilities (“Level 1”) and the lowest priority to unobservable inputs (“Level 3”). The three levels of the fair value hierarchy are described below:
| Level 1: | Values are based on unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities. |
|---|---|
| Level 2: | Values are based on quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, or other model-based valuation techniques for which all significant assumptions are observable in the market. |
| Level 3: | Values are generated from model-based techniques that use significant assumptions not observable in the market. |
As of December 31, 2024, and December 31, 2023 financial assets classified as Level 2 consisted of money market funds. The Company reviews trading activity and pricing for these investments as of the measurement date. When sufficient quoted pricing for identical securities is not available, the Company uses market pricing and other observable market inputs for similar securities. These inputs either represent quoted prices for similar assets in active markets or have been derived from observable market data. This approach results in the Level 2 classification of these securities within the fair value hierarchy.
As of December 31, 2024, financial liabilities classified as Level 3 consisted of the contingent consideration due to the APT acquisition. The Company reviews the change in the fair value of contingent consideration, which is performed by a third-party valuation firm. See Note 3 for further information regarding the valuation methods used by the third-party valuation firm. The approach results in the Level 3 classification of the contingent consideration within the fair value hierarchy.
Accounts Receivable, Contract Assets, and Allowance for Credit Losses
Accounts receivable primarily include amounts due from hospitals and distributors for acquisition of magnetic systems, associated disposable device sales and service contracts, net of allowances for expected credit losses. Credit is granted on a limited basis, with balances due generally within 30 days of billing. Contract assets primarily represent the difference between the revenue that was earned but not billed on service contracts and revenue from system contracts that was recognized based on the relative selling price of the related performance obligations and the contractual billing terms in the arrangements. Effective January 1, 2023, the Company reports accounts receivable and contract assets net of an allowance for expected credit losses in accordance with Accounting Standards Codification Topic 326, Financial Instruments – Credit Losses (“ASC 326”). The provision for credit loss is based upon management’s assessment of historical and expected net collections considering business and economic conditions and other collection indicators. We assess collectability by reviewing the accounts receivable aging schedule on an aggregated basis where similar characteristics exist and on an individual basis when we identify specific customers with known disputes or collectability issues. Amounts deemed uncollectible are recorded as an allowance for expected credit losses.
Inventory
The Company values its inventory at the lower of; (1) cost, as determined using the first-in, first-out (FIFO) method, or (2) net realizable value. The Company periodically reviews its physical inventory and provides a reserve upon identification of potential excess or obsolete items. Excess manufacturing overhead costs attributable to idle facility expenses or abnormally low production volumes are excluded from inventory and recorded as an expense in the period incurred.
Property and Equipment
Property and equipment consist primarily of leasehold improvements, construction in process, computer, office, research and demonstration equipment, and equipment held for lease and are stated at cost. Depreciation is calculated using the straight-line method over the estimated useful lives or life of the base lease term, ranging from three toten years.
Long-Lived Assets
If facts and circumstances suggest that a long-lived asset may be impaired, the carrying value is reviewed. If this review indicates that the carrying value of the asset will not be recovered, as determined based on projected undiscounted cash flows related to the asset over its remaining life, the carrying value of the asset is reduced to its estimated fair value, which in most cases is estimated based upon Level 3 inputs.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of theconsolidated financial statements and the reported amounts of income and loss during the reporting period. Actual results could differ from those estimates.
Revenue and Costs of Revenue
Revenue Recognition
The Company accounts for revenue in accordance with Accounting Standards Codification Topic 606 (“ASC 606”),Revenue from Contracts with Customers.
We generate revenue from initial capital sales of systems as well as recurring revenue from the sale of our proprietary disposable devices, from royalties paid to the Company on the sale of various devices as provided by co-development and co-placement arrangements, and from revenue including ongoing software updates and service contracts.
We account for a contract with a customer when there is a legally enforceable contract between the Company and the customer, the rights of the parties are identified, the contract has commercial substance, and collectability of the contract consideration is probable. We record our revenue based on consideration specified in the contract with each customer, net of any taxes collected from customers that are remitted to government authorities.
For contracts containing multiple products and services the Company accounts for individual products and services as separate performance obligations if they are distinct, which 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 recognizes revenues as the performance obligations are satisfied by transferring control of the product or service to a customer.
For arrangements with multiple performance obligations, 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 and market conditions. The Company regularly reviews standalone selling prices and updates these estimates if necessary.
Our revenue recognition policy affects the following revenue streams in our business as follows:
Systems:
Contracts related to the sale of systems typically contain separate obligations for the delivery of system(s), installation, service-type warranty, and an implied obligation to provide software enhancements if and when available for one year following installation. Revenue is recognized when the Company transfers control to the customer, which is generally at the point when acceptance occurs that indicates customer acknowledgment of delivery or installation, depending on the terms of the arrangement. Revenue from service-type warranties and the implied obligation to deliver software enhancements if and when available is included in Other Recurring Revenue and is recognized ratably typically over the first year following installation of the system as the customer receives the service-type warranty and right to software updates throughout the period. The Company’s system contracts generally do not provide a right of return. Systems may be covered by a one-year assurance-type warranty in lieu of a service-type warranty. Assurance-type warranty costs were less than $0.1 million and $0.5 million for the years ended December 31, 2024 and 2023, respectively. Revenue from system delivery and installation represented 32% and 33% of revenue for the years ended December 31, 2024 and 2023, respectively.
Disposables:
Revenue from sales of disposable products is recognized when control is transferred to the customers, which generally occurs at the time of shipment, but can also occur at the time of delivery depending on the customer arrangement. Disposable products are covered by an assurance-type warranty that provides for the return of defective products. Warranty costs were not material for the periods presented. Disposable revenue represented 30% and 24% of revenue for the years ended December 31, 2024 and 2023, respectively.
Royalty:
The Company receives royalties on the sale of various devices as provided by co-development and co-placement arrangements with various manufacturers. Royalty revenue represented less than 1% of revenue for the years ended December 31, 2024 and 2023.
Other Recurring Revenue:
Other recurring revenue includes revenue from product maintenance plans, service-type warranties, other post warranty maintenance, and the implied obligation to provide software enhancements if and when available for a specified period, typically one year following installation of our systems. Revenue from services and software enhancements is deferred and amortized over the service or update period, which is typically one year. Revenue related to services performed on a time-and-materials basis is recognized when performed. Other recurring revenue represented 38% and 43% of revenue for the years ended December 31, 2024 and 2023, respectively.
The following table summarizes the Company’s revenue for systems and disposables, service and accessories for the years ended December 31, 2024 and 2023 (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Systems | $8,632 | $8,739 |
| Disposables, service and accessories | 18,286 | 18,032 |
| Total revenue | $26,918 | $26,771 |
Transaction price allocated to remaining performance obligations relates to amounts allocated to products and services for which the revenue has not yet been recognized. A significant portion of this amount relates to the Company’s systems contracts and obligations that will be recognized as revenue in future periods. These obligations are generally satisfied within two years after contract inception but may occasionally extend longer. Transaction price representing revenue to be earned on remaining performance obligations on system contracts was approximately $15.2 million as of December 31, 2024. Performance obligations arising from contracts for disposables and service are generally expected to be satisfied within one year after entering into the contract.
The following information summarizes the Company’s contract assets and liabilities (in thousands):
| December 31, 2024 | December 31, 2023 | |
|---|---|---|
| Contract Assets - unbilled receivables | $90 | $72 |
| Customer deposits | $2,687 | $2,105 |
| Product shipped, revenue deferred | 1,708 | 1,413 |
| Deferred service and license fees | 4,473 | 4,776 |
| Total deferred revenue | $8,868 | $8,294 |
| Less: Long-term deferred revenue | (2,064) | (1,637) |
| Total current deferred revenue | $6,804 | $6,657 |
The Company invoices its customers based on the billing schedules in its sales arrangements. Contract assets primarily represent the difference between the revenue that was earned but not billed on service contracts and revenue from system contracts that was recognized based on the relative selling price of the related performance obligations and the contractual billing terms in the arrangements. Customer deposits primarily relate to future system sales but can also include deposits on disposable sales. Deferred revenue is primarily related to service contracts, for which the service fees are billed up-front, generally quarterly or annually, and for amounts billed in advance for system contracts for which some performance obligations remain outstanding. For service contracts, the associated deferred revenue is generally recognized ratably over the service period. For system contracts, the associated deferred revenue is recognized when the remaining performance obligations are satisfied. The Company did not have any impairment losses on its contract assets for the periods presented.
Revenue recognized for the years ended December 31, 2024 and 2023, that was included in the deferred revenue balance at the beginning of each reporting period was $5.5 million and $6.1 million, respectively.
Assets Recognized from the Costs to Obtain a Contract with a Customer
The Company has determined that sales incentive programs for the Company’s sales team meet the requirements to be capitalized as the Company expects to generate future economic benefits from the related revenue generating contracts after the initial capital sales transaction. The costs capitalized as contract acquisition costs included in prepaid expenses and other assets in the Company’s balance sheets were $0.1 million as of December 31, 2024 and 2023. The Company did not incur any impairment losses during any of the periods presented.
Cost of Contracts
Costs of systems revenue include direct product costs, installation labor and other costs, estimated warranty costs, initial training costs and product maintenance costs. These costs are recorded at the time of sale. Costs of disposable revenue include direct product costs and estimated warranty costs and are recorded at the time of sale. Cost of revenue from services and license fees are recorded when incurred.
Goodwill and Intangible Assets
Goodwill represents the excess of the purchase price over the fair value of the net assets acquired in business combinations and is allocated to the appropriate reporting unit when acquired. Other acquired intangible assets are stated at the fair value acquired. Goodwill is not amortized; rather, it is evaluated for impairment annually and whenever events or changes in circumstances indicate that the value of the asset may be impaired. Definite-lived intangible assets are considered long-lived assets and are amortized on a straight-line basis over the periods that expected economic benefits will be provided. See Note 3,Acquisitions for further discussion of the goodwill and intangible assets recorded as of the acquisition date and as of December 31, 2024.
Contingent Liabilities- Earnout Consideration
The Company has determined that the contingent consideration due under the terms of its July 31, 2024, acquisition agreement with APT Holding Company, Inc. represents a contingent liability in accordance with the provisions of Accounting Standard 805, Business Combinations. The Company has established short-term and long-term contingent liabilities for the net present fair value of contingent payments which are both probable of occurrence and reasonably estimable. The initial fair value of the contingent consideration both at the acquisition date and December 31, 2024 was determined by a third-party valuation firm using both a Monte Carlo simulation and probability-based approaches. The contingent consideration is remeasured to fair value at each reporting date until the contingency is resolved. Changes in fair value are recognized in the Company’s earnings as a charge to General and Administrative expenses. See Note 3,Acquisitions for further discussion of the contingent consideration recorded as of the acquisition date and as of December 31, 2024.
Leasing Arrangements
A lease is defined as a contract, or part of a contract, that conveys the right to control the use of identified property, plant or equipment for a period in exchange for consideration. The Company accounts for leases in accordance with Accounting Standards Update No. 2016-02 “Leases” (Topic 842) and all subsequent ASUs that modified Topic 842 (“ASC 842”). The Company determines if an arrangement contains a lease at inception.
The Company leases its facilities under operating leases. In accordance with ASC 842, operating lease agreements are recognized on the balance sheet as a right-of-use (“ROU”) asset and a corresponding lease liability. These leases generally do not have significant rent escalation holidays, concessions, leasehold improvement incentives, or other build-out clauses. Further, the leases do not contain contingent rent provisions. Many of our leases include both lease (i.e., fixed payments including rent, taxes, and insurance costs) and non-lease components (i.e., common-area or other maintenance costs) which are accounted for as a single lease component as we have elected the practical expedient to group lease and non-lease components for all leases.
The Company’s lease agreements often include one or more options to renew at the Company’s discretion. If at lease inception, the Company considers the exercising of a renewal option to be reasonably certain, the Company will include the extended term in the calculation of the ROU asset and lease liability. The Company elected not to include short-term leases (i.e., leases with initial terms of twelve months or less) on the balance sheet.
The calculated amounts of the ROU assets and lease liabilities are impacted by the length of the lease term and the discount rate used to calculate the present value of the minimum lease payments. ASC 842 requires the use of the discount rate implicit in the lease whenever this rate is readily determinable. As this rate is rarely determinable, the Company utilizes its incremental borrowing rate at lease inception.
Research and Development Costs
Internal research and development costs are expensed in the period incurred. Amounts receivable from strategic relationships under research reimbursement agreements are recorded as a contra-research and development expense in the period reimbursable costs are incurred. There were no material receivables as of December 31, 2024 or 2023, under these types of agreements. Advance receipts or other unearned reimbursements are included in accrued liabilities on the accompanying balance sheet until earned.
Stock-Based Compensation
The Company accounts for its grants of stock options, non-qualified stock options, stock appreciation rights, restricted shares, and restricted stock units and for its employee stock purchase plan in accordance with the provisions of general accounting principles for share-based payments. These accounting principles require the determination of the fair value of the stock-based compensation at the grant date and the recognition of the related expense over the period in which the stock-based compensation vests.
For time-based awards, the Company utilizes the Black-Scholes valuation model to determine the fair value of stock options and stock appreciation rights at the date of grant. The weighted average assumptions and fair value for options granted during the year ended December 31, 2024, were 1) expected dividend rate of 0%; 2) expected volatility of 75% based on the Company’s historical volatility; 3) risk-free interest rate based on the Treasury yield on the date of grant; and 4) expected term of 6.25 years. The resulting compensation expense is recognized over the requisite service period, which is generally four years, net of actual forfeitures. Restricted shares and units granted to employees and non-employee directors are valued at the fair market value at the date of grant. The Company amortizes the fair market value to expense over the service period. If the shares are subject to performance objectives, the resulting compensation expense is amortized over the anticipated vesting period and is subject to adjustment based on the actual achievement of objectives.
For market-based awards, stock-based compensation expense is recognized over the minimum service period regardless of whether or not the market target is probable of being achieved. The fair value of such awards is estimated on the grant date using Monte Carlo simulations.
Shares purchased by employees under the 2022 Employee Stock Purchase Plan are considered to be non-compensatory.
Net Loss per Common Share
Basic earnings (loss) per common share is computed by dividing the net earnings (loss) for the period by the weighted average number of common shares outstanding during the period. In periods where there is net income, we apply the two-class method to calculate basic and diluted net income (loss) per share of common stock, as our convertible preferred stock is a participating security. The two-class method is an earnings allocation formula that treats a participating security as having rights to earnings that otherwise would have been available to common stockholders. In periods where there is a net loss, the two-class method of computing earnings per share does not apply as our convertible preferred stock does not contractually participate in our losses. We compute diluted net income (loss) per common share using net income (loss) as the “control number” in determining whether potential common shares are dilutive, after giving consideration to all potentially dilutive common shares, including stock options, unvested restricted stock units outstanding during the period and potential issuance of stock upon the conversion of our convertible preferred stock issued and outstanding during the period, except where the effect of such securities would be antidilutive.
The Company did not include any portion of unearned restricted shares, outstanding options, stock appreciation rights, or convertible preferred stock in the calculation of diluted loss per common share because all such securities are anti-dilutive for all periods presented. The application of the two-class method of computing earnings per share under general accounting principles for participating securities is not applicable during these periods because those securities do not contractually participate in its losses.
As of December 31, 2024, the Company had 3,858,360 shares of common stock issuable upon the exercise of outstanding options and stock appreciation rights at a weighted average exercise price of $3.79 per share,49,371,307 shares of our common stock issuable upon conversion of our Series A Convertible Preferred Stock, and 1,546,532 shares of unvested restricted share units. The Company hadno unearned restricted shares outstanding for the period ended December 31, 2024.
In accordance with general accounting principles for income taxes*,* a deferred income tax asset or liability is determined based on the difference between the financial statement and tax basis of assets and liabilities as measured by the enacted tax rates that will be in effect when these differences reverse. The Company provides a valuation allowance against net deferred income tax assets unless, based upon available evidence, it is more likely than not that the deferred income tax assets will be realized.
Product Warranty Provisions
The Company’s standard policy is to warrant all products against defects in material or workmanship for one year following sale or installation. Contracts related to the sale of systems typically contain a service-type warranty which is accounted for as a separate performance obligation in ASC 606,Revenue from Contracts with Customers. For assurance-type warranties, the Company’s estimate of costs to service the warranty obligations is based on historical experience and current product performance trends. A regular review of warranty obligations is performed to determine the adequacy of the reserve and adjustments are made to the estimated warranty liability (included in other accrued liabilities) as appropriate.
Patent Costs
Costs related to filing and pursuing patent applications are expensed as incurred, as recoverability of such expenditures is uncertain.
Concentrations of Risk
No single customer accounted for more than 10% of total revenue for the years ended December 31, 2024 and 2023. No single country, other than the U.S., accounted for more than 10% of total revenue for the years ended December 31, 2024 and 2023.
Recently Issued Accounting Pronouncements
In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-13, “Financial Instruments-Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments” and also issued subsequent amendments to the initial guidance under ASU 2018-19, ASU 2019-04 and ASU 2019-05. The standard modifies the measurement approach for credit losses on financial instruments, including trade receivables, from an incurred loss method to a current expected credit loss method, otherwise known as “CECL.” The standard requires the measurement of expected credit losses to be based on relevant information, including historical experience, current conditions and a forecast that is supportable. The Company adopted the standard in the first quarter of 2023. The adoption of ASC 326 had no material impact on the Company’s financial results for any prior periods, therefore no cumulative adjustment to beginning retained earnings was recorded.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), which requires enhanced income tax disclosures, primarily related to the effective tax rate reconciliation and income taxes paid. The Company does not expect a significant impact to its income tax disclosures upon adoption of the Update which will be effective in the Company’s year ending December 31, 2025.
3. Acquisitions
Acquisition of Access Point Technologies EP, Inc. (“APT”):
On July 31, 2024, the Company acquired all the shares of capital stock of Access Point Technologies EP, Inc. (“APT”), a Minnesota corporation, from APT Holding Company, Inc., a Minnesota corporation. APT designs, manufactures, and commercializes a portfolio of differentiated high-quality diagnostic catheters used during cardiac ablation procedures that are commercially available across key global geographies.
The acquisition of APT was accounted for as a business combination using the acquisition method of accounting. The consideration included an upfront payment and additional contingent payments based upon the achievement of key regulatory and commercial milestones. At closing, the Company issued 1,486,620 shares of its common stock (the “Upfront Stock Consideration”) with a value of $3.0 million. The Share Purchase Agreement obligated us to file a resale registration statement relating to the Upfront Stock Consideration and additional Earnout Shares. The registration statement covered the 1,486,620 Closing Shares and an estimated 4,613,380 additional Earnout Shares. However, the exact number of shares that may be issued under the Share Purchase Agreement for such milestones will be calculated based on the average of the closing per share price of Stereotaxis common stock immediately prior to the dates such revenue performance and/or regulatory milestones are achieved, up to $24.0 million in total value through September 30, 2029, not to exceed 19.9% of the total number of shares of the Company’s common stock issued and outstanding immediately prior to July 31, 2024 (the “Share Cap Limitation”). In addition, the vesting of the right to receive the Earnout Shares would be accelerated in the event of a change of control of Stereotaxis, based on a probability-weighted average estimate of the potential to achieve any remaining milestones, discounted to its net present value taking into account expected time when earnouts related to the milestones would become payable through September 30, 2029. The estimated fair value of the contingent consideration related to the additional earnout shares at the acquisition date was $9,966. The total contingent consideration, including the upfront, payment is estimated to be $12,966.
The following table summarizes the estimated fair value of the assets acquired and liabilities assumed for APT as of the acquisition date (in thousands):
| (in thousands) | July 31, 2024 |
|---|---|
| Assets acquired: | |
| Current assets | |
| Cash | $108 |
| Accounts receivable, net of allowance of $19 | 693 |
| Inventories, net | 1,607 |
| Prepaid expenses and other current assets | 1 |
| Total current assets | 2,409 |
| Property and equipment | 825 |
| Goodwill | 3,764 |
| Intangible assets | 7,740 |
| Total assets acquired | $14,738 |
| Liabilities assumed: | |
| Current liabilities | |
| Accounts payable | $1,723 |
| Accrued liabilities | 49 |
| Total liabilities assumed | $1,772 |
| Net assets acquired | $12,966 |
The above purchase price allocation is preliminary and subject to revision as additional information about the fair value of individual assets and liabilities becomes available. The Company is currently awaiting additional information to finalize the fair values of potential acquired deferred tax balances. A change in the estimated fair value of the net assets acquired will change the amount of the purchase price allocated to goodwill.
For purposes of the above allocation, we based our estimate of the fair values for contingent consideration, intangible assets, and property and equipment on valuation studies performed by third-party valuation firms. We used various valuation methods, including discounted cash flows, distributor method, excess earnings, and relief from royalty method to estimate the fair value of the identified intangible assets. The fair value of the contingent consideration was determined using a Monte Carlo simulation and probability based approaches. The Cost approach was utilized to determine the fair value of property and equipment. Goodwill and other intangible assets reflected above were determined to meet the criteria for recognition apart from tangible assets acquired and liabilities assumed. The goodwill is primarily attributable to APT’s in-house research and development team versus using third party developers and the expansion of manufacturing capacity. The tax basis in the acquired goodwill is zero.
The Company’s consolidated statement of earnings for the year ended December 31, 2024, includes APT post-acquisition revenue of $1,942. Net loss for the year ended December 31, 2024 was $2,858. Net loss for the year ended December 31, 2024, includes $1,798 of expense due to the revaluation of the contingent consideration as of the reporting date. This expense is recognized within General and Administrative expenses for the year ended December 31, 2024.
| (in thousands) | |
|---|---|
| Year Ended December 31, | |
| Revenue | $1,942 |
| Net loss | (2,858) |
The following represents the pro forma consolidated revenue as if APT had been included in the consolidated results of the Company. Revenue was $29,859 for the year ended December 31, 2024, and $33,052 for the year ended December 31, 2023.
The Company incurred acquisition costs of $451 that were recognized within General and Administrative expenses for the year ended December 31, 2024.
The intangible assets related to the acquisition consisted of the following:
| (in thousands) | Fair Value | Amortization Period |
|---|---|---|
| Intangible assets subject to amortization: | (in thousands) | (in years) |
| Developed technology | $6,250 | 7.0 - 8.0 |
| Customer relationships | 310 | 10.0 |
| Trademark | 410 | 5.0 |
| Total intangible assets subject to amortization | $6,970 | |
| Intangible assets not subject to amortization | ||
| In process research and development | 770 | N/A |
| Goodwill | $3,764 | N/A |
| Total intangible assets not subject to amortization | 4,534 | |
| Total intangible assets | $11,504 | |
| Weighted average amortization period | 7.7 | |
4. Financial Instruments
The following table summarizes the Company’s cash and cash equivalents, amortized cost, gross unrealized gains, gross unrealized losses, and fair value by significant category reported as cash and cash equivalents and restricted cash as of December 31, 2024 and 2023:
| Reported as: | |||||||
|---|---|---|---|---|---|---|---|
| (in thousands) · Cash and Cash Equivalents · Restricted Cash- current · Short-term Investments · Restricted Cash | |||||||
| Cash | $969 | $ | - | $ | - | $ | - |
| Money market funds | 11,248 | 219 | - | - | |||
| Subtotal | 11,248 | 219 | - | - | |||
| Total assets measured at fair value | $12,217 | $219 | $ | - | $ | - | |
| Reported as: | |||||||
|---|---|---|---|---|---|---|---|
| (in thousands) · Cash and Cash Equivalents · Restricted Cash- current · Short-term Investments · Restricted Cash | |||||||
| Cash | $2,122 | $ | - | $ | - | $ | - |
| Money market funds | 17,696 | 525 | - | 219 | |||
| Subtotal | 17,696 | 525 | - | 219 | |||
| Total assets measured at fair value | $19,818 | $525 | $ | - | $219 | ||
Interest income recorded for these cash and investments was $0.7 million and $1.1 million during the years ended December 31, 2024, and December 31, 2023, respectively.
As of December 31, 2024 and 2023, the Company did not have any financial assets classified as Level 1.
5. Inventory
Inventory consists of the following (in thousands):
| December 31, 2024 | December 31, 2023 | |
|---|---|---|
| Raw materials | $5,223 | $5,918 |
| Work in process | 1,103 | 1,034 |
| Finished goods | 4,382 | 3,413 |
| Reserve for excess and obsolescence | (2,377) | (1,939) |
| Total inventory | $8,331 | $8,426 |
At the closing of the acquisition, GAAP accounting required us to record all acquired inventory at its market value.
The Company had approximately $2.4 million in reserve for excess and obsolescence. The reserve includes the fair value of slow-moving acquired inventory and the value of Niobe Systems and related raw materials and spare parts.
6. Prepaid Expenses and Other Current Assets
Prepaid expenses and other assets consist of the following (in thousands):
| December 31, 2024 | December 31, 2023 | |
|---|---|---|
| Prepaid expenses | $405 | $181 |
| Prepaid commissions | 78 | 110 |
| Deposits | 411 | 424 |
| Deferred cost of revenue | 1,025 | - |
| Other assets | 36 | 98 |
| Total prepaid expenses and other assets | 1,955 | 813 |
| Less: Noncurrent prepaid expenses and other assets | (107) | (137) |
| Total current prepaid expenses and other assets | $1,848 | $676 |
Deferred cost of revenue represents the cost of systems for which the system has been delivered to the customer but for which revenue has not been recognized.
7. Property and Equipment
Property and equipment consist of the following (in thousands):
| December 31, 2024 | December 31, 2023 | |
|---|---|---|
| Equipment | $5,098 | $4,269 |
| Leasehold improvements | 2,916 | 2,911 |
| Gross property and equipment | 8,014 | 7,180 |
| Less: Accumulated depreciation | (4,441) | (3,876) |
| Net property and equipment | $3,573 | $3,304 |
The Company retired less than $0.1 million and approximately $0.2 million of fully depreciated assets during the years ended December 31, 2024 and 2023, respectively. The Company had approximately $0.9 million and $0.1 million of property and equipment additions during the years ended December 31, 2024 and 2023, respectively, associated with the APT acquisition as of December 31, 2024 and the buildout of the new leased space in St. Louis, Missouri as of December 31, 2023.
8. Intangible Assets
Intangible Assets consist of the following (in thousands):
| December 31, 2024 | December 31, 2023 | |
|---|---|---|
| Goodwill | 3,764 | |
| Developed technology | 6,250 | - |
| In process research and development | 770 | - |
| Customer relationships | 310 | - |
| Trademark | 410 | - |
| Total intangibles | 11,504 | - |
| Less: Accumulated amortization | (382) | - |
| Net intangibles | $11,122 | - |
We recognized amortization expense of $0.4 million in 2024. We expect to recognize annual amortization expense of $0.9 million in 2025, $0.9 million in 2026, $0.9 million in 2027, $0.9 million in 2028, and $0.9 million in 2029 related to our intangible assets balance as of December 31, 2024.
9. Leases
On March 1, 2021, the Company entered into an office lease agreement (the “Globe Lease”) with Globe Building Company, under which the Company leases executive office space and manufacturing facilities of approximately 43,100 square feet of rentable space located at 710 N. Tucker Boulevard, St. Louis, Missouri (the “Premises”) that serves as the Company’s new principal executive and administrative offices and manufacturing facility. Lease payments commenced on January 1, 2022, and the lease has a term often years, withtwo renewal options offive years each. The minimum annual rent under the terms of the Globe Lease ranges from approximately $0.8 million in 2022 to $1.0 million in 2031.
On July 31, 2024, the Company entered into a lease agreement (the “Talulla Lease”) with Talulla Group LLC, under which the Company will lease office space and manufacturing facilities of approximately 11,300 square feet of rentable space located at 12560 Fletcher Lane, Rogers, Minnesota that will continue to serve as the APT’s office and manufacturing facility. Lease payments commenced on August 1, 2024, and the lease has a term offour years, withtwo renewal options offour years each. The minimum annual rent under the terms of the Talulla Lease is approximately $0.2 million per year. In accordance with ASC 842, the Company recorded a ROU asset and lease liability in third quarter of 2024. The initial recognition of the ROU asset and lease liability was $1.0 million.
The Company also has leased office space in Amsterdam, The Netherlands through June 30, 2025. In addition, we lease an office space in Beijing, China under a lease agreement through November 29, 2026.
As of December 31, 2024, the weighted average discount rate for operating leases was 9% and the weighted average remaining lease term for operating lease term is 7.09 years.
The following table represents lease costs and other lease information (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Operating lease cost | $980 | $908 |
| Short-term lease cost | 10 | 17 |
| Total net lease cost | $990 | $925 |
| Cash paid within operating cash flows | $1,096 | $1,000 |
Variable lease costs consist primarily of taxes, insurance, and common area or other maintenance costs for our leased facilities and equipment which are paid based on actual costs incurred.
Future minimum payments for operating leases with initial or remaining terms of one year or more as of December 31, 2024, were as follows (in thousands):
| 2025 | $1,079 |
| 2026 | 1,097 |
| 2027 | 1,122 |
| 2028 | 1,147 |
| 2029 | 1,173 |
| 2030 and thereafter | 2,533 |
| Total lease payments | 8,151 |
| Less: Interest | (2,145) |
| Present value of lease liabilities | $6,006 |
10. Accrued Liabilities
Accrued liabilities consist of the following (in thousands):
| December 31, 2024 | December 31, 2023 | |
|---|---|---|
| Accrued salaries, bonus, and benefits | $1,569 | $1,222 |
| Accrued licenses and maintenance fees | - | 484 |
| Accrued warranties | 50 | 107 |
| Accrued professional services | 170 | 138 |
| Accrued investigational sites | 45 | - |
| Deferred contract obligation | 1,045 | 1,045 |
| Other | 107 | 19 |
| Total accrued liabilities | 2,986 | 3,015 |
| Less: Long term accrued liabilities | (64) | (43) |
| Total current accrued liabilities | $2,922 | $2,972 |
11. Convertible Preferred Stock and Stockholders’ Equity
The holders of common stock are entitled to one vote for each share held and to receive dividends whenever funds are legally available and when declared by the Board of Directors subject to the rights of holders of all classes of stock having priority rights as dividends. No dividends have been declared or paid as of December 31, 2024.
Series B Convertible Preferred Stock
On August 7, 2019, the Company entered into a Securities Purchase Agreement with certain institutional and other accredited investors, whereby it, as part of a private placement, agreed to issue and sell to the investors 5,610,121 shares of the Company’s Series B Convertible Preferred Stock (the “Series B Preferred Stock”), $0.001 par value per share which were convertible into shares of the Company’s common stock, at a price of $2.05 per share. In April 2023, all of the outstanding shares of Series B Convertible Preferred Stock were converted into shares of common stock on a one-for-one basis by the holder. The Series B Preferred Stock, which was a common stock equivalent but non-voting and with a blocker on conversion if the holder exceeded a specified threshold of voting security ownership, was convertible into common stock on a one-for-one basis, subject to adjustment for events such as stock splits, combinations and the like as provided in the Purchase Agreement. The Series B Preferred Stock was reported in the stockholders’ equity section of the Company’s balance sheet.
Series A Convertible Preferred Stock and Warrants
In September 2016, the Company issued (i)24,000 shares of Series A Convertible Preferred Stock, par value $0.001 per share, with a stated value of $1,000 per share (the “Series A Preferred Stock”), which are convertible into shares of the Company’s common stock at an initial conversion rate of $0.65 per share, subject to adjustment for events such as stock splits, combinations and the like as provided in the certificate of designations covering such Series A Preferred Stock, and (ii) warrants (the “SPA Warrants”) to purchase an aggregate of 36,923,078 shares of common stock. The shares of Series A Preferred Stock are entitled to vote on an as-converted basis with the common stock, subject to specified beneficial ownership issuance limitations. The Series A Preferred Stock bear dividends at a rate of six percent (6%) per annum, which are cumulative and accrue daily from the date of issuance on the $1,000 stated value. Such dividends will not be paid in cash except in connection with any liquidation, dissolution or winding up of the Company or any redemption of the Series A Preferred Stock. Each holder of convertible preferred shares has the right to require us to redeem such holder’s shares of Series A Preferred Stock upon the occurrence of specified events, which include certain business combinations, the sale of all or substantially all of the Company’s assets, or the sale of more than 50% of the outstanding shares of the Company’s common stock. In addition, the Company has the right to redeem the Series A Preferred Stock in the event of a defined change of control. The Series A Preferred Stock ranks senior to our common stock as to distributions and payments upon the liquidation, dissolution, and winding up of the Company. Since the Series A Preferred Stock are subject to conditions for redemption that are outside the Company’s control, the Series A Preferred Stock are presently reported in the mezzanine section of the balance sheet.
The SPA Warrants were modified on February 28, 2018 to allow for a reduction in the exercise price from $0.70 per share to $0.28 per share for a period between March 1, 2018 and March 5, 2018 and to modify certain beneficial ownership limitations and to eliminate certain redemption rights, resulting in, among other things, the exercise of a substantial number of the SPA Warrants for cash. The remaining unexercised 15,385 Warrants expired on September 29, 2021.
2021 CEO Performance Award Unit Grant
On February 23, 2021, the Company`s Board of Directors, upon recommendation of the Compensation Committee, approved the grant of the CEO Performance Award to the Company’s Chief Executive Officer. The CEO Performance award is a 10-year performance award of up to 13,000,000 shares, tied to the achievement of market capitalization milestones and subject to minimum service requirements.
As detailed in the table below, the CEO Performance Award consists of ten vesting tranches. The first market capitalization milestone is $1.0 billion, and each of the remaining nine market capitalization milestones are in additional $500 million increments, up to $5.5 billion.
| Tranche # | No. of Shares Subject to PSU | Market Capitalization Milestones |
|---|---|---|
| 1 | 1,000,000 | $1,000,000,000 |
| 2 | 1,500,000 | $1,500,000,000 |
| 3 | 1,500,000 | $2,000,000,000 |
| 4 | 2,000,000 | $2,500,000,000 |
| 5 | 1,000,000 | $3,000,000,000 |
| 6 | 1,000,000 | $3,500,000,000 |
| 7 | 1,000,000 | $4,000,000,000 |
| 8 | 2,000,000 | $4,500,000,000 |
| 9 | 1,000,000 | $5,000,000,000 |
| 10 | 1,000,000 | $5,500,000,000 |
| Total: | 13,000,000 |
Each tranche represents a portion of the PSUs covering the number of shares outlined in the table above. Each tranche vests upon (i) satisfaction of the market capitalization milestones and (ii) continued employment as CEO of the Company from the grant date through December 31, 2030. Absent an earlier termination, the PSUs will expire on December 31, 2030. If our CEO ceases employment as CEO of the Company for any reason including death, disability, termination for cause or without cause (as defined in the award agreement), or if he voluntary terminates after service as CEO for at least five years, the remaining service period will be waived and he will retain any PSUs that have vested through the date of termination.
The Company received Shareholder approval at its annual meeting on May 20, 2021, for shares to be issued under the award.
The market capitalization requirement is considered a market condition under FASB Accounting Standards Codification Topic 718 “Compensation – Stock Compensation” and is estimated on the grant date using Monte Carlo simulations. Recognition of stock-based compensation expense of all the tranches commenced on February 23, 2021, the date of grant, as the probability of meeting the ten market capitalization milestones is not considered in determining the timing of expense recognition. The expense will be recognized on an accelerated basis through 2030. Key assumptions for estimating the performance-based awards fair value at the date of grant included share price on grant date, volatility of the Company’s common stock price, risk free interest rate, and grant term.
Total stock-based compensation recorded as operating expense for the CEO Performance Award was $7.2 million and $7.1 million for the years ended December 31, 2024 and 2023, respectively. The Company had approximately $29.8 million and $37.0 million of total unrecognized stock-based compensation expense remaining as of December 31, 2024 and 2023, respectively, under the CEO Performance Award assuming the grantee’s continued employment as CEO of the Company, or in a similar capacity, through 2030. As of December 31, 2024, none of the performance milestones established by the 2021 CEO Incentive Program have been achieved and no awards have been earned.
Stock Award Plans
The Company has various stock plans that permit the Company to provide incentives to employees, directors, and third-party consultants of the Company in the form of equity compensation. In February 2022, the Compensation Committee of the Board of Directors adopted the 2022 Stock Incentive Plan (the “Plan”) which was subsequently approved by the Company’s shareholders. This plan replaced the 2012 Stock Incentive Plan which expired on May 19, 2022.
As of December 31, 2024, the Company had 5,317,547 remaining shares of the Company’s common stock to provide for current and future grants under its various equity plans.
The 2022 Stock Incentive Plan allows for the grant of incentive stock options, non-qualified stock options, stock appreciation rights, restricted shares and restricted share units to employees, directors, and third-party consultants. Options granted under the 2022 Stock Incentive Plan expire no later thanten years from the date of grant. The exercise price of each incentive stock option shall not be less than 100% of the fair value of the stock subject to the option on the date the option is granted. The vesting provisions of individual options may vary, but incentive stock options generally vest 25% on the first anniversary of each grant and 1/48 per month over the next three years. Stock appreciation rights are rights to acquire a calculated number of shares of the Company’s common stock upon exercise of the rights. The number of shares to be issued is calculated as the difference between the exercise price of the right and the aggregate market value of the underlying shares on the exercise date divided by the market value as of the exercise date. Stock appreciation rights granted under the 2022 Stock Incentive Plan generally vest 25% on the first anniversary of such grant and 1/48 per month over the next three years and expire no later thanten years from the date of grant. The Company generally issues new shares upon the exercise of stock options and stock appreciation rights.
The fair value of the grants for restricted shares and units is determined based on the closing price of our stock on the date of grant. Restricted stock unit grants are time-based and generally vest over a period offour years except for grants to directors which are generally earned over a period of six months.
As of December 31, 2024, the total compensation cost related to options, stock appreciation rights, and non-vested stock granted to employees and non-employees under the Company’s stock award plans but not yet recognized was approximately $2.6 million, excluding compensation not yet recognized related to the CEO Performance Award discussed above. This cost will be amortized over a period of up tofour years over the underlying estimated service periods and will be adjusted for subsequent changes in actual forfeitures and anticipated vesting periods.
A summary of the option and stock appreciation rights activity for the year ended December 31, 2024, is as follows:
| Number of Options/SARs | Range of Exercise Price | Weighted Average Exercise Price per Share | |
|---|---|---|---|
| Outstanding, December 31, 2023 | 3,650,115 | $0.74 - $9.87 | $3.93 |
| Granted | 790,000 | $1.90 - $3.01 | $2.90 |
| Exercised | (151,503) | $0.74 - $2.57 | $1.41 |
| Forfeited | (430,252) | $0.74 - $9.87 | $4.17 |
| Outstanding, December 31, 2024 | 3,858,360 | $0.74 - $9.20 | $3.79 |
As of December 31, 2024, the weighted average remaining contractual life of the options and stock appreciation rights outstanding was 6.63 years. Of the 3,858,360 options and stock appreciation rights that were outstanding as of December 31, 2024,2,580,740 were vested and exercisable with a weighted average exercise price of $4.09 per share and a weighted average remaining term of 5.6 years.
A summary of the options and stock appreciation rights outstanding by range of exercise price is as follows:
| Number of · Weighted | |||||
|---|---|---|---|---|---|
| Weighted · Weighted · Options · Average Exercise | |||||
| Options · Average · Average · Currently · Price Per Vested | |||||
| Range of Exercise Prices | Outstanding | Remaining Life | Exercise Price | Exercisable | Share |
| $0.00 - $1.00 | 235,426 | 3.16 | $0.74 | 235,426 | $0.74 |
| $1.01 - $2.00 | 119,766 | 8.78 | $1.77 | 26,748 | $1.53 |
| $2.01 - $4.00 | 1,717,634 | 7.42 | $2.59 | 741,786 | $2.25 |
| $4.01 - $10.00 | 1,785,534 | 6.18 | $5.47 | 1,576,780 | $5.50 |
| 3,858,360 | 6.63 | $3.79 | 2,580,740 | $4.09 | |
The intrinsic value of options and stock appreciation rights is calculated as the difference between the exercise price of the underlying awards and the quoted price of the Company’s common stock for the options and stock appreciation rights that were in-the-money as of December 31, 2024. The intrinsic value of the options and stock appreciation rights outstanding as of December 31, 2024, was approximately $0.5 million based on a closing share price of $2.28 on December 31, 2024. There were 725,326 fully vested options or stock appreciation rights outstanding as of December 31, 2024, with an exercise price lower than the closing stock price on December 31, 2024. During the year ended December 31, 2024, the aggregate intrinsic value of options and stock appreciation rights exercised under the Company’s stock option plans was $0.1 million.
The intrinsic value of the options and stock appreciation rights outstanding as of December 31, 2023, was approximately $0.3 million based on a closing share price of $1.75 on December 31, 2023. There were 337,408 fully vested options or stock appreciation rights outstanding as of December 31, 2023, with an exercise price lower than the closing stock price on December 31, 2023. During the year ended December 31, 2023, the aggregate intrinsic value of options and stock appreciation rights exercised under the Company’s stock option plans was less than $0.1 million.
The weighted average grant date fair value of options granted during the years ended December 31, 2024 and 2023, was $2.90 per share and $2.53 per share, respectively.
A summary of the restricted stock unit activity for the year ended December 31, 2024, is as follows:
| Number of Restricted Stock Units | Weighted Average Grant Date Fair Value per Unit | |
|---|---|---|
| Outstanding, December 31, 2023 | 1,502,131 | $3.94 |
| Granted | 696,945 | $1.69 |
| Vested | (652,544) | $2.91 |
| Outstanding, December 31, 2024 | 1,546,532 | $3.36 |
The intrinsic value of restricted stock units outstanding as of December 31, 2024, was $3.5 million based on a closing share price of $2.28 as of December 31, 2024. The intrinsic value of restricted stock units outstanding as of December 31, 2023, was $2.6 million based on a closing share price of $1.75 as of December 31, 2023. During the year ended December 31, 2024, the aggregate intrinsic value of restricted stock units vested was $1.3 million determined at the date of vesting.
2022 Employee Stock Purchase Plan
In 2022, the Company adopted its 2022 Employee Stock Purchase Plan (“ESPP”). Eligible employees can participate in a new purchase period every 3 months. Under the terms of the plan, employees can purchase up to 15% of their compensation of the Company’s common stock, subject to an annual maximum of $25,000, at 95% of the fair market value of the stock at the end of the purchase period, subject to certain plan limitations. As of December 31, 2024, there were 304,682 remaining shares available for issuance under the Employee Stock Purchase Plan.
The Company has reserved shares of common stock for conversion of convertible preferred stock, estimated additional earnout shares to APT, and the issuance of options granted under the Company’s stock option plan and its stock purchase plan as follows:
| December 31, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| Series A Convertible Preferred Stock | 52,502,740 | 54,704,831 |
| Performance Share Unit Plan | 13,000,000 | 13,000,000 |
| Stock award plans | 5,317,547 | 2,690,393 |
| APT additional earnout shares | 4,613,380 | - |
| Employee Stock Purchase Plan | 304,682 | 107,688 |
| Reserved shares of common stock | 75,738,349 | 70,502,912 |
12. Income Taxes
The provision for income taxes consists of the following (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Deferred: | ||
| Federal | $(2,577) | $(2,108) |
| State and local | 378 | (773) |
| Total deferred income tax expense (benefit) | (2,199) | (2,881) |
| Valuation allowance | 2,199 | 2,881 |
| Income tax benefit | $— | $— |
The provision for income taxes varies from the amount determined by applying the U.S. federal statutory rate to income before income taxes as a result of the following:
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| U.S. statutory income tax rate | 21.0% | 21.0% |
| State and local taxes, net of federal tax benefit | 0.8% | 1.7% |
| Stock compensation permanent differences between book and tax | (8.0)% | (7.2)% |
| Contingent consideration permanent difference | (1.6)% | —% |
| Other permanent differences between book and tax | (0.7)% | (2.4)% |
| State rate adjustments | (2.4)% | 2.1% |
| Other adjustments | 0.0% | (1.3)% |
| Valuation allowance | (9.1)% | (13.9)% |
| Effective income tax rate | —% | —% |
The stock compensation permanent difference relates to the February 3, 2021, Board approved grant of Performance Share Unit Award pursuant to the CEO Performance Share Unit Award Agreement (the “PSU Agreement”) to David L. Fischel, the Company’s Chief Executive Officer. Total stock-based compensation attributed to the PSU Agreement was $7.2 million and $7.1 million for the years ended December 31, 2024 and 2023, respectively, of which only a portion was allowed as a tax deduction in those years due to Internal Revenue Code Section 162(m) limitations. Included in other permanent differences between book and tax in the table above are differences such as incentive stock option expenses, nondeductible meals and entertainment, and transactions costs. The state rate adjustments are a result of changes in apportionment and various state rate law changes.
The components of net deferred tax assets and liabilities are as follows (in thousands):
| Year Ended December 31, | ||||
|---|---|---|---|---|
| 2024 · 2023 | ||||
| Current accruals | $1,001 | $1,041 | ||
| Operating lease liabilities | 1,372 | 1,330 | ||
| Deferred revenue | 30 | 68 | ||
| Depreciation and amortization | 4,058 | 3,172 | ||
| Deferred compensation | 1,402 | 1,570 | ||
| Net operating loss carryovers | 33,198 | 29,118 | ||
| Tax credit carryovers | 462 | - | ||
| Deferred tax assets | 41,523 | 36,299 | ||
| Valuation allowance | (38,851) | (35,066) | ||
| Net deferred tax assets before deferred tax liabilities | 2,672 | 1,233 | ||
| Operating lease right-of-use assets | (1,252) | (1,207) | ||
| Amortization of intangibles | (1,333) | - | ||
| Inventory | (69) | - | ||
| Capitalized compensation costs | (18) | (26) | ||
| Net deferred tax assets | $ | - | $ | - |
Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an “ownership change,” the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes, such as research tax credits, to offset its post-change income may be limited. In general, an “ownership change” will occur if there is a cumulative change in our ownership by “5-percent shareholders” that exceeds 50 percentage points over a rolling three-year period. Similar rules may apply under state tax laws. Following significant ownership changes during 2013, the Company initiated a review of the availability of its U.S. net operating loss carryforwards. As a result of this review, it was determined that a large portion of the Company’s net operating loss carryovers would expire unused due to the limitation under IRC Section 382. The Company reduced the net operating loss carryover and corresponding valuation allowance as a result of these limitations as reflected in the net operating loss carryovers in the table above. The remaining net operating loss carryforwards following the ownership change have been assigned a full valuation allowance against all deferred tax assets.
In assessing the realizability of deferred tax assets, the Company considers whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. The Company considers projected future taxable income and tax planning strategies in making this assessment. Based upon the level of historical taxable losses, and projections for future periods over which the deferred tax assets are deductible, the Company determined that a 100% valuation allowance of deferred tax assets was appropriate.
As of December 31, 2024, we had gross federal net operating loss carryforwards arising from our operations of approximately $134.9 million. The federal net operating loss carryforwards reflect accumulated book losses reduced for the 2013 IRC Section 382 ownership change limitation of $188.0 million, book/tax differences and expiration of carryforwards. The federal net operating loss carryforwards generated prior to the 2018 tax year of approximately $98.8 million will expire between 2030 and 2037. The federal net operating losses generated in 2018 and thereafter will be carried forward indefinitely as a result of changes in the tax law following the Tax Cuts and Jobs Act (“TCJA”). As of December 31, 2024, we had gross state net operating loss carryforward of approximately $38.1 million which will expire at various dates between 2025 and 2043 if not utilized.
In addition to the net operating loss carryovers related to our operations, in connection with our acquisition of APT as discussed in Note 3, we acquired federal and state net operating loss and tax credit carryovers of APT. Our ability to utilize those carryovers and credits will be limited under IRC Section 382. The Section 382 limited net operating loss carryovers total approximately $9.1 million, of which $0.6 million was incurred prior to the 2018 effective date of the TCJA and will expire between 2035 and 2037 with the remainder available for indefinite carryforward. The applicable state net operating loss carryforwards related to APT are approximately $9.6 million with $9.1 million expiring at various dates between 2030-2038 with the remaining carried forward indefinitely. The acquired tax credit carryovers total $0.2 million for federal income tax purposes, which expire between 2036 and 2043, and state credit carryovers of $0.3 million, which expire between 2031 and 2038. Consistent with our conclusion with respect to the need for valuation allowances associated with our other deferred tax assets, the net deferred tax assets related to APT of $1.6 million at the acquisition date as well as those at December 31, 2024 were fully included in our valuation allowance.
The Company files income tax returns in the U.S. federal jurisdiction and various state and local jurisdictions. As the Company has a federal net operating loss carryforward from the year ended December 31, 2003 forward, all tax years from 2003 forward are subject to examination. As states have varying carryforward periods, and the Company has recently entered into additional states, the states are generally subject to examination for the previous 10 years or less.
At December 31, 2024 and 2023, the Company had less than $0.1 million in reserves for uncertain tax positions. The Company recognizes interest accrued, if any, net of tax and penalties, related to unrecognized tax benefits as components of the income tax provision, as applicable. As of December 31, 2024 and 2023, accrued interest and penalties were less than $0.1 million.
13. Net Loss per Share
The following is a reconciliation of the numerator (net loss) and the denominator (number of shares) used in the basic and diluted earnings per share calculations (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Net loss | $(24,045) | $(20,713) |
| Cumulative dividend on convertible preferred stock | (1,308) | (1,343) |
| Net loss attributable to common stockholders | $(25,353) | $(22,056) |
| Weighted average number of common shares and equivalents: | 85,183,306 | 80,702,358 |
| Basic EPS | $(0.30) | $(0.27) |
| Diluted EPS | $(0.30) | $(0.27) |
The following table sets forth the number of common shares that were excluded from the computation of diluted earnings per share because their inclusion would have been anti-dilutive as follows:
| December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Shares issuable upon vesting/exercise of: | ||
| Options to purchase common stock | 3,858,360 | 3,650,115 |
| Series A Convertible Preferred Stock and Accumulated Dividends | 49,371,307 | 49,375,135 |
| Restricted stock units | 1,546,532 | 1,502,131 |
| 54,776,199 | 54,527,381 | |
14. Employee Benefit Plan
The Company offers employees the opportunity to participate in a 401(k) plan and matches employee contributions up to 3% of each participating employee’s compensation. The Company recognized expense of approximately $0.3 million for the years ended December 31, 2024 and 2023.
15. Product Warranty Provisions
The Company’s standard policy is to warrant all capital systems against defects in material or workmanship for one year following installation with an assurance or a service-type warranty. The Company’s estimate of costs to service the warranty obligations is based on historical experience and current product performance trends. A regular review of warranty obligations is performed to determine the adequacy of the reserve and adjustments are made to the estimated warranty liability as appropriate.
Accrued assurance-type warranty, which is included in other accrued liabilities, consists of the following (in thousands):
| December 31, 2024 | December 31, 2023 | |
|---|---|---|
| Warranty accrual, beginning of the fiscal period | $107 | $163 |
| Accrual adjustment for product warranty | 6 | 547 |
| Payments made | (63) | (603) |
| Warranty accrual, end of the fiscal period | $50 | $107 |
16. Commitments and Contingencies
The Company at times becomes a party to claims in the ordinary course of business. Management believes that the ultimate resolution of pending or threatened proceedings will not have a material effect on the financial position, results of operations or liquidity of the Company. In 2024, security agreements were executed under the provisions of the Uniform Commercial Code (“UCC”), and UCC financing statements have been filed by a vendor on underlying inventory for approximately $0.6 million. We believe the financing statements have been filed without merit, and we are fully contesting the propriety of such actions.
In April 2021, the Company entered into a letter of credit pursuant to the Lease agreement totaling approximately $1.8 million to be delivered in four equal instalments of which the first was delivered in April 2021, the second was delivered in July 2021, the third was delivered in October 2021, and the fourth was delivered in January 2022. The amount available under this letter of credit automatically reduces by one fortieth at the end of each month during the lease term.
17. Segment Information
The Company considers reporting segments in accordance with general accounting principles for disclosures about segments of an enterprise and related information. The Company’s system and disposable devices are developed and marketed to a broad base of hospitals in the United States and internationally. The Company considers all such sales to be part of a single operating segment. Geographic revenues for the years ended December 31, 2024 and 2023 were as follows (in thousands):
| Year Ended December 31, | ||
|---|---|---|
| 2024 | 2023 | |
| United States | $13,427 | $18,199 |
| International | 13,491 | 8,572 |
| Total | $26,918 | $26,771 |
All of the Company’s long-lived assets are located in the United States. Revenues are attributed to countries based on the location of the customer.
18. Subsequent Events
None.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.