IRADIMED CORP
For the period ended Dec 31, 2023. Filed Mar 1, 2024.
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FY2023 · Filed Mar 1, 2024
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Notes to Financial Statements
1 — Organization and Significant Accounting Policies
Organization
IRADIMED CORPORATION (“IRADIMED”, the “Company”, “we”, “our”) was incorporated in Oklahoma in July 1992 and reincorporated in Delaware in April 2014. We develop, manufacture, market and distribute a Magnetic Resonance Imaging (“MRI”) compatible intravenous (“IV”) infusion pump system and MRI compatible patient vital signs monitoring systems and related accessories, disposables and services.
We are a leader in the development of innovative MRI compatible medical devices. We are the only known provider of a non-magnetic IV infusion pump system that is specifically designed to be safe for use during MRI procedures. We were the first to develop an infusion delivery system that largely eliminates many of the dangers and problems present during MRI procedures. Standard infusion pumps contain magnetic and electronic components which can create radio frequency interference and are dangerous to operate in the presence of the powerful magnet that drives an MRI system. Our patented MRidium® MRI compatible IV infusion pump system has been designed with a non-magnetic ultrasonic motor, uniquely designed non-ferrous parts and other special features to safely and predictably deliver anesthesia and other IV fluids during various MRI procedures. Our pump solution provides a seamless approach that enables accurate, safe and dependable fluid delivery before, during and after an MRI scan, which is important to critically ill patients who cannot be removed from their vital medications, and children and infants who must generally be sedated to remain immobile during an MRI scan.
Each IV infusion pump system consists of an MRidium® MRI compatible IV infusion pump, non-magnetic mobile stand, proprietary disposable IV tubing sets and many of these systems contain additional optional upgrade accessories.
Our 3880 MRI compatible patient vital signs monitoring system has been designed with non-magnetic components and other special features to safely and accurately monitor a patient’s vital signs during various MRI procedures. The IRADIMED 3880 system operates dependably in magnetic fields up to 30,000 gauss, which means it can operate virtually anywhere in the MRI scanner room. The IRADIMED 3880 has a compact, lightweight design allowing it to travel with the patient from their critical care unit, to the MRI and back, resulting in increased patient safety through uninterrupted vital signs monitoring and decreasing the amount of time critically ill patients are away from critical care units. The features of the IRADIMED 3880 include: wireless ECG with dynamic gradient filtering; wireless SpO2 using Masimo® algorithms; non-magnetic respiratory CO2; invasive and non-invasive blood pressure; patient temperature, and optional advanced multi-gas anesthetic agent unit featuring continuous Minimum Alveolar Concentration measurements. The IRADIMED 3880 MRI compatible patient vital signs monitoring system has an easy-to-use design and allows for the effective communication of patient vital signs information to clinicians.
Our headquarters is located in Winter Springs, Florida.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities in the financial statements and the reported amount of revenue and expenses during the reporting period. Such estimates include allowances for potentially uncollectible accounts receivable, valuation of inventory, intangible assets, stock-based compensation, deferred income taxes, reserves for warranty obligations, and the provision for income taxes. Actual results could differ from those estimates.
Revenue Recognition
We generate revenue from the sale of MRI compatible medical devices and accessories, extended warranty agreements, services related to maintaining our products and the sale of disposable products used with our devices. The principal customers for our MRI compatible products include hospitals and acute care facilities, both in the U.S. and internationally. In the U.S. we sell our products through our direct sales force and outside of the U.S. we sell our products through third-party distributors who resell our products to end users.
For many domestic sales, we enter into agreements with integrated delivery health systems and healthcare supply contracting companies, commonly referred to as Group Purchasing Organizations (“GPOs”).
GPO agreements enable us to sell and distribute our products to their member hospitals. Our agreements with GPOs typically include negotiated pricing for all group members established at the time of GPO contract execution. Under these agreements, we are required to pay the GPOs a fee ofthree percent of the sales of our products to members of the GPO. We do not sell to GPOs. Hospitals, group practices and other acute care facilities that are members of a GPO, purchase products directly from us under the terms of our GPO agreements.
We recognize revenue when all of the following criteria are met: we have a contract with a customer that creates enforceable rights and obligations; promised products or services are identified; the transaction price, or the amount we expect to receive, is determinable and we have transferred control of the promised products or services to the customer. We consider transfer of control evidenced upon the passage of title and risks and rewards of ownership to the customer, which is typically at a point in time, except for our extended warranty agreements. We allocate the transaction price using the relative standalone selling price method.
Customer sale prices for our medical devices and related disposables and services are contractually fixed over the contract term. We recognize a receivable at the point in time we have an unconditional right to payment. Payment terms are typically within 45 days after transferring control to U.S. customers. Most international distributors are required to pay a portion of the transaction price in advance and the remaining amount within 30 days of receiving the related products. Accordingly, we have elected to use the practical expedient that allows us to ignore the possible existence of a significant financing component within the contract.
We have elected to account for shipping and handling charges billed to customers as revenue and shipping and handling related expenses as cost of revenue.
In certain U.S. states we are required to collect sales taxes from our customers. We have elected to exclude the amounts collected for these taxes from revenue and record them as a liability until remitted to the taxing authority.
Contract Liabilities
We record contract liabilities, or deferred revenue, when we have an obligation to provide a product or service to the customer and payment is received in advance of our performance. When we sell a product or service with a future performance obligation, we defer revenue allocated to the unfulfilled performance obligation and recognize this revenue when, or as, the performance obligation is satisfied.
Our deferred revenue consists of advance payments received from customers prior to the transfer of products or services, shipments that are in-transit at the end of a period and sales of extended warranty agreements. Advance payments received from customers and shipments in-transit are recognized in revenue at the time control of the related products has been transferred to the customer or services have been delivered. Amounts related to extended warranty agreements are deferred and recognized in revenue ratably over the agreement period, which is typicallyone tofour years after control of the related products is transferred to the customer, as we believe this recognition pattern best depicts the transfer of services being provided.
Deferred revenue is classified as current or long-term deferred revenue in our Balance Sheets, depending on the expected timing of satisfying the related performance obligations.
Capitalized Contract Costs
We capitalize commissions paid to our sales managers related to contracts with customers when the associated revenue is expected to be earned over a period of time. Deferred commissions are primarily related to the sale of extended warranty agreements. Capitalized commissions are included in Prepaid Expenses and Other Current Assets in our Balance Sheets when the associated expense is expected to be recognized in one year or less, or in Other Assets when the associated expense is expected to be recognized in greater than one year. The associated expense is included in Sales and Marketing expenses in our Statements of Operations.
Variable Consideration
Our sales are typically subject to 30 to 60-day customer-specified acceptance provisions primarily for purposes of ensuring products were not damaged during the shipping process. Historically, we have experienced immaterial product returns and, when experienced, we typically exchange the affected products with new products. Accordingly, variable consideration from contracts with customers is immaterial to our financial statements.
Cash Equivalents
All highly liquid instruments purchased with an original maturity of three months or less are classified as cash equivalents.
Accounts Receivable and Allowance for Doubtful Accounts
Accounts receivable is recorded at the transaction price of the related products and services. We regularly assess the sufficiency of the allowance for estimated uncollectible accounts receivable. Estimates are based on historical collection experience and other customer-specific information, such as bankruptcy filings or known liquidity problems of our customers. When it is determined that an account receivable is uncollectible, it is written off and relieved from the allowance. Any future determination that the allowance for estimated uncollectible accounts receivable is not properly stated could result in changes in operating expense and results of operations. As of December 31, 2023 and 2022, our allowance for doubtful accounts was $368,835 and $160,498, respectively.
Investments
Investments, held in the past, consisted of corporate debt securities and were considered available-for-sale. The specific identification method was used to determine the cost basis of investments sold. Our investments were recorded in our Balance Sheets at fair value. We classified our investments as current based on the nature of the investments and their availability for use in current operations. Unrealized gains and losses on our investments were included in accumulated other comprehensive income (loss), net of tax. Realized gains or losses and impairment losses that were determined to be other-than-temporary were recorded in other income, net, in our Statements of Operations. As of December 31, 2023, we do not own any corporate debt securities, but should direct debt securities be utilized in the future, we would treat them as described above.
Fair Value Measurements
Fair value is the price that would be received to sell an asset or paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants on the measurement date. A three-level valuation hierarchy requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.
The valuation hierarchy is based upon the transparency of inputs to the valuation of an asset or liability on the measurement date. The three levels of inputs are:
| ● | Level 1 — quoted prices (unadjusted) in active markets for an identical asset or liability. |
| ● | Level 2 — quoted prices for a similar asset or liability in an active market or model-derived valuations in which all significant inputs are observable for substantially the full term of the asset or liability. |
| ● | Level 3 — unobservable and significant to the fair value measurement of the asset or liability. |
Financial instruments include cash and cash equivalents, investments, accounts receivable, accounts payable and accrued expenses. Cash and cash equivalents and investments are reported at their respective fair values on the balance sheet dates. The recorded carrying amount of accounts receivable, accounts payable and accrued expenses approximates their fair values due to their short-term nature.
Inventory
Inventory is stated at the lower of standard cost, which approximates actual cost on a first-in, first-out basis, or net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. We may be exposed to a number of factors that could result in portions of our inventory becoming either obsolete or in excess of anticipated usage. These factors include, but are not limited to, technological changes, competitive pressures in products and prices, and the introduction of new product lines. We regularly evaluate our ability to realize the value of inventory based on a combination of factors, including historical usage rates, forecasted sales, product life cycles, and market acceptance of new products. When inventory that is obsolete or in excess of anticipated usage is identified, it is written down to net realizable value or an inventory valuation allowance is established.
Property and Equipment
Property and equipment are stated at cost less accumulated depreciation. Depreciation expense is computed using the straight-line method over estimated useful lives of the respective assets, which are generally three tofive years for computer software and hardware andfive toseven years for furniture, fixtures, machinery andequipment. Leasehold improvements are depreciated over the shorter of the lease term or the estimated useful life of the improvements.
Repair and maintenance costs that do not extend the useful life of our property and equipment are expensed as incurred.
Intangible Assets
Intangible assets include application and legal costs incurred to obtain patents. We capitalize these costs when we determine that probable future economic benefits exist. In making this determination, we consider the projected future operating results associated with the patents, industry and economic trends, and the entry of new products in the market. Costs incurred prior to this determination are expensed in the period they are incurred. We amortize capitalized patent costs using the straight-line method over their useful lives, which is typically 20 years. Periodic costs incurred to maintain existing patents are expensed as incurred.
Research & Development and Capitalized Software Development Costs
Research and development costs are expensed as incurred. Some of our products include embedded software which is essential to the products’ functionality. Costs incurred in the research and development of new software components and enhancements to existing software components are expensed as incurred until technological feasibility has been established. We capitalize software development costs when the product reaches technological feasibility and cease capitalization when the product is ready for commercial sale. Capitalized software development costs are included in intangible assets and are amortized on a straight-line basis over the estimated useful life of the product and included in cost of revenue. Amortization begins when the product is available for general sales to customers.
Long-lived Assets
Long-lived assets, including right-of-use assets, are tested for impairment whenever changes in circumstances indicate the carrying value of these assets may be impaired. Impairment indicators include, but are not limited to, technological obsolescence, unfavorable court rulings, significant negative industry and economic trends, and significant underperformance relative to historical and projected future operating results. Impairment is considered to have occurred when the estimated undiscounted future cash flows related to the asset groups are less than its carrying value. Estimates of future cash flows involve consideration of many factors including the marketability of new products, product acceptance and lifecycle, competition, appropriate discount rates and operating margins. An impairment is recognized as the amount by which the carrying value is greater than the fair value of the asset or asset group.
Warranty
The Company provides for the estimated cost of product warranties at the time revenue is recognized. While we engage in product quality programs and processes, including actively monitoring and evaluating the quality of our suppliers, the estimated warranty obligation is affected by ongoing product failure rates, material usage costs and direct labor incurred in correcting a product failure. Actual product failure rates, material usage costs and the amount of labor required to repair products that differ from estimates result in revisions to the estimated liability. We warrant for a limited period of time that our products will be free from defects in materials and workmanship. We estimate warranty allowances based on historical warranty experience. The estimates we use in projecting future product warranty costs may prove to be incorrect. Any future determination that our provision for product warranty is understated could result in increases to our cost of revenue and a reduction in our operating profits and results of operations. Historically, warranty expenses have not been material to our financial statements.
Stock-Based Compensation
Historically, we have granted three types of employee equity awards, stock options, restricted stock units and performance-based restricted stock units.
We recognize stock-based compensation expense associated with employee equity awards on a straight-line basis over the requisite service period for stock options and restricted stock units, which is generally four years for employees andtwo years for the board of directors. Expense related to our performance-based restricted stock units is recognized straight-line over the requisite performance period, which is three years.
The grant date fair value of our restricted stock units is based on the closing price of our common stock on the date of grant.
In December 2023 and 2022, the Company granted Performance-Based Restricted Stock Units (“PSUs”) to certain employees under the Company’s Long-Term Incentive Pan (“LTIP”), which was adopted under the Company’s Amended and Restated 2014 Equity Incentive Plan. Payouts of the PSUs will be based on the Company’s total shareholder return compared to a peer group or index total shareholder return. For purposes of the LTIP, total shareholder return is calculated as the share price at the end of the performance period, which is three years, including the reinvestment of any dividends during the performance period, as compared to the share price at the beginning of the performance period. The payout range for participants will be between 0 percent and 200 percent, depending on the Company’s relative total return performance.
The grant date fair value of our PSUs is based on a Monte Carlo simulation, the closing price of our common stock, and other pertinent factors on the grant date. Compensation expense for the PSUs is recognized on a straight-line basis over the requisite performance period, which is three years from the grant date.
We elect to recognize forfeitures as they occur.
We issue new shares of common stock upon exercise of stock options or vesting of restricted stock units and PSUs.
Income Taxes
We account for income taxes under the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. The effect of a change in tax rates on deferred tax assets and liabilities is recognized in income in the period that includes the enactment date.
We record net deferred tax assets to the extent we believe these assets will more likely than not be realized. In making such determination, we consider all available positive and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax planning strategies and recent financial operations. A valuation allowance is recorded to offset net deferred tax assets if, based upon the available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.
We recognize the tax benefit of uncertain tax positions, if any, in the financial statements based on the technical merits of the position. When the tax position is deemed more likely than not of being sustained, we recognize the largest amount of tax benefit that is greater than 50 percent likely of being ultimately realized upon settlement.
Foreign Currency
Gains and losses from transactions denominated in currencies other than our functional currency are included in other income, net. Foreign currency gains and losses result primarily from fluctuations in the exchange rate between the U.S. Dollar and the Japanese Yen.
Comprehensive Income
Comprehensive income includes net income and other comprehensive income items that are excluded from net income under U.S. GAAP. Comprehensive income included unrealized gains and losses on our investments classified as available for sale while those investments were held.
Basic and Diluted Net Income per Share
Basic net income per share is based on the weighted-average number of common shares outstanding during the period. Diluted net income per share reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock. The stock options, restricted stock units, and performance-based restricted stock units granted by us represent the only dilutive effect reflected in diluted weighted average shares outstanding.
The following table presents the computation of basic and diluted net income per share:
| · · · · · · · | ||||||
|---|---|---|---|---|---|---|
| · · For the Year Ended December 31, · | ||||||
| · · 2023 · 2022 · | ||||||
| · · · · · · · | ||||||
| Net income | | $17,192,776 | | $12,828,487 | | |
| Weighted-average shares outstanding — Basic | | 12,602,948 | | 12,562,856 | | |
| Effect of dilutive securities: | | | | |||
| Stock options | | 17,654 | | 20,106 | | |
| Restricted stock units | | | 63,340 | | 43,037 | |
| Performance-based restricted stock units | | 38,588 | | 9,972 | | |
| Weighted-average shares outstanding — Diluted | | 12,722,530 | | 12,635,971 | | |
| Basic net income per share | | $1.36 | | $1.02 | | |
| Diluted net income per share | | $1.35 | | $1.02 | | |
Stock options to purchase shares of our common stock and restricted stock units excluded from the calculation of diluted net income per share because the effect would have been anti-dilutive are as follows:
| · · · · · | |||
|---|---|---|---|
| · Year Ended · | |||
| | | December 31, | |
| · · 2023 · · 2022 · | |||
| | | | |
| Anti-dilutive stock options and restricted stock units | 419 | 22,744 | |
Certain Significant Risks and Uncertainties
We market our products to end users in the United States and to third-party distributors internationally. Sales to end users in the United States are generally made on open credit terms. Management maintains an allowance for potential credit losses.
We have deposited our cash and cash equivalents with various financial institutions. Our cash and cash equivalents balances exceed federally insured limits periodically throughout the year. We have not incurred any losses related to these balances.
Our medical devices require clearance from the Food and Drug Administration and international regulatory agencies prior to commercialized sales. Our future products may not receive required approvals. If we were denied such approvals, or if such approvals were revoked or delayed or if we were unable to timely renew certain approvals for existing products, it would have a materially adverse impact on our business, results of operations and financial condition.
Certain key components of our products essential to their functionality are sole-sourced. Any disruption in the availability of these components would have a materially adverse impact on our business, results of operations and financial condition.
Pandemic Considerations
We continue to monitor developments associated with the recent evolving pandemic and its effects on our employees, customers, supply chain and distribution channels. The ongoing impact of the recent and potential future pandemics depends on several factors including the severity and duration of the pandemic and the extent and severity of the impact on our customers, which is uncertain and unpredictable. Our future results of operations and cash flows may suffer adverse effects from disruptions in our supply chain and manufacturing operations, delays in payments on outstanding accounts receivable, uncertain demand for our products, and effects of any actions we may take to address financial and operational challenges our customers may face. Our future results may potentially be heavily determined by global vaccination rates, duration of the pandemic, its geographic spread, further business disruptions and the overall impact on the global economy.
We are actively managing our response to the recent pandemic and continue to work with our customers, distributors, vendors, and suppliers and assessing the potential effects to our financial position, results of operations and cash flows. As of the date of the issuance of these financial statements, the extent to which a pandemic may materially impact our financial condition, liquidity, or results of operations in future periods remains uncertain.
Recent Accounting Pronouncements
Accounting Pronouncements Implemented in 2023
Beginning in 2022, the Tax Cuts and Jobs Act of 2017 (“TCJA”) eliminated the option to deduct research and experimental expenditures in the current year and requires taxpayers to amortize them over five or fifteen years pursuant to IRC Section 174. This change is applied from 2022 onward prospectively and impacts the timing of the related cash tax payments as the deductions are disallowed for tax in the year incurred but allowed for tax purposes to be amortized
and deducted over 5 years. The mandatory capitalization requirement increased our deferred tax assets andcash tax liabilities by approximately $0.5 million as of and for the year ended December 31, 2023. In the future, Congress may consider legislation that would defer the amortization requirement to later years, possibly with a retroactive effect. In the meantime, we expect to continue to make additional Federal tax payments based on current Section 174 tax law. The impact of Section 174 on our cash from operations depends on the amount of research and experimental expenditures incurred by the company and whether the IRS issues guidance on the provision which differs from current interpretation, among other things.
Recently Issued Accounting Pronouncements to be Implemented
In June 2016, the FASB issued ASU 2016-13,* Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments*, which requires the Company to measure and recognize expected credit losses for financial assets held and not accounted for at fair value through net income. In November 2018, April 2019 and May 2019, the FASB issued ASU 2018-19,Codification Improvements to Topic 326, Financial Instruments - Credit Losses, ASU 2019-04,Codification Improvements to Topic 326, Financial Instruments - Credit Losses and ASU 2019-05,Financial Instruments - Credit Losses (Topic 326): Targeted Transition Relief, which provided additional implementation guidance on ASU 2016-03. The previously mentioned ASUs are effective for fiscal years beginning after December 15, 2022, with early adoption permitted. The adoption of these ASUs did not have a material impact on our financial condition, results of operations or cash flows.
2 — Revenue
Disaggregation of Revenue
We disaggregate revenue from contracts with customers by geographic region and revenue type as we believe it best depicts the nature, amount, timing and uncertainty of our revenue and cash flow.
Revenue information by geographic region is as follows:
| · · · · · · | ||||
|---|---|---|---|---|
| | Year Ended | |||
| · · December 31, | ||||
| · · 2023 · 2022 | ||||
| · · | ||||
| United States | | $52,525,449 | | $43,898,735 |
| International | | 13,036,847 | | 9,404,410 |
| Total revenue | | $65,562,296 | | $53,303,145 |
Revenue information by type is as follows:
| · · · · · · | ||||
|---|---|---|---|---|
| | Year Ended | |||
| · · December 31, | ||||
| · · 2023 · 2022 | ||||
| · · | ||||
| Devices: · · | ||||
| MRI Compatible IV Infusion Pump Systems | | $19,611,128 | | $14,526,017 |
| MRI Compatible Patient Vital Signs Monitoring Systems | | 25,414,537 | | 21,721,720 |
| Ferro Magnetic Detection Systems | | 944,793 | | 257,112 |
| Total Devices revenue | | 45,970,458 | | 36,504,849 |
| Disposables, services and other | | 17,578,366 | | 14,622,327 |
| Amortization of extended warranty agreements | | 2,013,472 | | 2,175,969 |
| Total revenue | | $65,562,296 | | $53,303,145 |
Contract Liabilities
Our contract liabilities consist of:
| · · · · · | |||
|---|---|---|---|
| · December 31, · December 31, | |||
| | 2023 | | 2022 |
| · · · · | |||
| Advance payments from customers | $508,956 | | $896,617 |
| Shipments in-transit | 15,438 | | 14,696 |
| Extended warranty agreements | 4,835,966 | | 3,837,006 |
| Total | $5,360,360 | | $4,748,319 |
Changes in the contract liabilities during the period are as follows:
| · · | |
|---|---|
| | Deferred |
| | Revenue |
| · · | |
| Contract liabilities, December 31, 2021 | $4,232,439 |
| Increases due to cash received from customers | 5,094,184 |
| Decreases due to recognition of revenue | (4,578,304) |
| Contract liabilities, December 31, 2022 | $4,748,319 |
| Increases due to cash received from customers | 5,089,484 |
| Decreases due to recognition of revenue | (4,477,443) |
| Contract liabilities, December 31, 2023 | $5,360,360 |
Capitalized Contract Costs
Our capitalized contract costs totaled $162,134 and $340,044 as of December 31, 2023 and 2022, respectively.
3 — Inventory, net
Inventory consists of:
| · · · · · | |||
|---|---|---|---|
| | As of December 31, | ||
| | 2023 | | 2022 |
| · · · · | |||
| Raw materials | $10,833,004 | | $4,827,113 |
| Work in process | 501,191 | | 369,761 |
| Finished goods | 1,907,729 | | 411,647 |
| Inventory before allowance for excess and obsolete | 13,241,924 | | 5,608,521 |
| Allowance for excess and obsolete | (420,730) | | (239,288) |
| Total | $12,821,194 | | $5,369,233 |
4 — Property and Equipment, net
Property and equipment consist of:
| | | | | | |
|---|---|---|---|---|---|
| · December 31, · December 31, | |||||
| · 2023 · · 2022 | |||||
| · · · · | |||||
| Land | $6,253,790 | | $— | ||
| Computer software and hardware | | 1,380,289 | | | 1,121,455 |
| Furniture and fixtures | 1,757,129 | | 1,573,587 | ||
| Leasehold improvements | 270,486 | | 259,146 | ||
| Machinery and equipment | 2,438,922 | | 2,210,181 | ||
| Fixed assets in-process | 1,257,844 | | 665,773 | ||
| | 13,358,460 | | 5,830,142 | ||
| Accumulated depreciation | (4,069,835) | | (3,430,330) | ||
| Total | $9,288,625 | | $2,399,812 | ||
Depreciation expense of property and equipment was $648,133 and $569,551 for the year ended December 31, 2023 and 2022, respectively.
Property and equipment, net by geographic region is as follows:
| · · · · · | |||
|---|---|---|---|
| · December 31, · December 31, | |||
| | 2023 | | 2022 |
| · · · · | |||
| United States | $8,950,580 | | $2,248,308 |
| International | 338,045 | | 151,504 |
| Total property and equipment, net | $9,288,625 | | $2,399,812 |
Long-lived assets held outside of the United States consist principally of tooling, which is a component of machinery and equipment, net.
5 — Intangible Assets, net
The following table summarizes the components of intangible asset balances:
| · · · · · | |||
|---|---|---|---|
| · December 31, · December 31, | |||
| | 2023 | | 2022 |
| · · · · | |||
| Patents — in use | $321,874 | | $321,873 |
| Patents — fully amortized | 70,164 | | 70,164 |
| Patents — in process | 128,221 | | 123,153 |
| Internally developed software — in use | 1,773,720 | | 872,218 |
| Internally developed software — in process | 1,149,409 | | 1,489,322 |
| Trademarks | 27,697 | | 27,697 |
| | 3,471,085 | | 2,904,427 |
| Accumulated amortization | (952,032) | | (834,988) |
| Total | $2,519,053 | | $2,069,439 |
Amortization expense of intangible assets was $117,047 and $101,122 for the year ended December 31, 2023, and 2022, respectively.
Expected annual amortization expense for the next five years related to intangible assets is as follows (excludes in-process intangible assets):
| · · | |
|---|---|
| 2024 | $229,330 |
| 2025 | $226,190 |
| 2026 | $214,444 |
| 2027 | $140,731 |
| 2028 | $138,129 |
6 — Accumulated Other Comprehensive Income
The only component of accumulated other comprehensive income related to unrealized gains and (losses) on our investments was as follows:
| · · | |
|---|---|
| | Unrealized (Losses) |
| | Gains on |
| | Available-For-Sale |
| | Securities |
| Balance at December 31, 2021 | $17,012 |
| (Gain) Loss on available-for-sale securities, net | (10,953) |
| Reclassification realized in net earnings | (6,059) |
| Balance at December 31, 2022 | $— |
| (Gain) Loss on available-for-sale securities, net | — |
| Reclassification realized in net earnings | — |
| Balance at December 31, 2023 | $— |
7 — Stock-Based Compensation
In April 2014, our Board of Directors adopted and our shareholders approved the 2014 Equity Incentive Plan (“2014 Plan”). Upon adoption and approval of the 2014 Plan, the previous equity incentive plan was terminated and the remaining shares available for future awards were canceled. The 2014 Plan initially reserved 1,000,000 shares of our common stock for awards of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock, restricted stock units, performance awards and other stock-based and cash awards. On June 12, 2020, the shareholders approved an amendment to the 2014 Plan, which reserved an additional 1,000,000 shares of our common stock for the various equity awards mentioned above. As of December 31, 2023, there were 969,303 shares available for future awards under the 2014 Plan. The 2014 Plan expires in April 2024 and the remaining shares available for future awards will be cancelled.
On June 15, 2023, our Board of Directors adopted, and our shareholders approved the 2023 Equity Incentive Plan (“2023 Plan”). The 2023 Plan reserves 1,500,000 shares of our common stock for awards of incentive stock options, non-qualified stock options, stock appreciation rights, restricted stock, restricted stock units, performance awards and other stock-based awards. The 2023 Plan will expire on June 15, 2033, when any remaining shares available for future awards will be cancelled.
Stock-based compensation was recognized as follows in the Statements of Operations:
| · · · · · · · | |||||
|---|---|---|---|---|---|
| · Year Ended · | |||||
| · · December 31, · | |||||
| · 2023 · 2022 · | |||||
| · · · | |||||
| Cost of revenue | | $247,848 | | $195,574 | |
| General and administrative | | 1,183,644 | | 604,626 | |
| Sales and marketing | | 562,940 | | 438,864 | |
| Research and development | | 192,477 | | 155,042 | |
| Total | | $2,186,909 | | $1,394,106 | |
Stock Options
The following table presents a summary of our stock option activity as of and for the year ended December 31, 2023:
| | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|
| · · · · Weighted-Average · | ||||||||||
| · · · · Weighted-Average · · Remaining · · Aggregate | ||||||||||
| · · · · Exercise Price · · Contractual · · Intrinsic | ||||||||||
| · Options · Per Share · Life (Yrs.) · Value | ||||||||||
| Outstanding beginning of period | 24,010 | $8.59 | — | $— | ||||||
| | | | | | | | | | | |
| Options granted | — | | | — | — | | | — | ||
| Options exercised | (21,000) | | | 8.42 | — | | | — | ||
| Options cancelled | — | | | — | — | | | — | ||
| Options expired | — | | | — | — | | | — | ||
| Outstanding end of period | 3,010 | $9.84 | 0.96 | $113,266 | ||||||
| Exercisable | 3,010 | $9.84 | 0.96 | $113,266 | ||||||
The total intrinsic value of options exercised during the year ended December 31, 2023 and 2022 was $698,855 and $598,967 respectively.
No options were granted during the years ended December 31, 2023 and December 31, 2022.
Restricted Stock Units
The following table presents a summary of our restricted stock unit activity as of and for the year ended December 31, 2023:
| · · · · · | ||
|---|---|---|
| | Restricted | Weighted-Average |
| · · Stock · · Grant Date | ||
| | Units | Fair Value |
| Unvested at December 31, 2022 | 151,337 | $30.57 |
| Granted | 46,080 | $41.16 |
| Vested | (54,282) | $29.34 |
| Cancelled/Forfeited | (1,808) | $30.01 |
| Unvested at December 31, 2023 | 141,327 | $34.50 |
As of December 31, 2023, we had $4,170,643 of unrecognized compensation cost related to the unvested restricted stock units, which is expected to be recognized over a weighted-average period of 2.57 years.
Performance-Based Restricted Stock Units
The following table presents a summary of our Performance-Based Restricted Stock Unit (“PSU”) activity as of and for the year ended December 31, 2023:
| · · · · · | ||
|---|---|---|
| · · Performance-Based · · Weighted-Average | ||
| · · Restricted · · Grant Date | ||
| | Stock Units | Fair Value |
| Unvested at December 31, 2022 | 27,884 | $40.03 |
| Granted | 13,160 | $59.28 |
| Vested | (4,252) | $29.53 |
| Cancelled/Forfeited | — | $0 |
| Unvested at December 31, 2023 | 36,792 | $48.13 |
During the year ended December 31, 2023, the Company awarded 13,160 PSUs. The awards will vest three years from the award date based on the achievement of certain performance criteria approved by the Compensation Committee.
During the year ended December 31, 2022, the Company awarded 18,819 PSUs. The awards will vest three years from the award date based on the achievement of certain performance criteria approved by the Compensation Committee.
Based on the level of achievement of the performance criteria at the end of thethree years for each of the PSUs awarded, the number of shares earned can range from 0 percent to 200 percent of the remaining shares outstanding; therefore, the maximum number of shares that can be issued under these awards is twice the original remaining outstanding awards of 36,792 PSUs, or 73,584 shares. Currently, for accounting purposes, we assume the full 73,584 are probable.
For the year ended December 31, 2023, the Company recognized $17,779 in stock compensation expense related to the 13,160 PSUs granted in December 2023 compared to $12,249 in stock compensation expense for the same period recognized in 2022 related to the 18,819 PSUs granted in December 2022.
For the year ended December 31, 2023, the grant date fair value of the PSUs was $59.28 per unit, which was calculated using a Monte-Carlo simulation model with an expected term ofthree years and a risk-free interest rate of 4.36%. The Monte-Carlo simulation incorporated the volatility and dividend yield for the Company and the Nasdaq US Small Cap Medical Equipment Index. Index volatility was 37.1% and dividend yield was 1.0%. The volatility and dividend yield used for the Company was 49.7% and 1.0%, respectively.
As of December 31, 2023, we had $1,308,461 of unrecognized compensation cost related to the unvested PSUs, which is expected to be recognized over a weighted-average period of 2.45 years.
8 — Other Income, Net
Other income, net consists of:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · For the Years Ended December 31, | ||||||
| · 2023 · 2022 | ||||||
| Interest income | $1,864,113 | $581,852 | ||||
| Realized gains on maturities of investments | | | — | | | 8,025 |
| Foreign currency exchange losses | | | (148,842) | | | (36,773) |
| Disposal of Assets | | | (12,473) | | | 0 |
| Total other income, net | $1,702,798 | $553,104 | ||||
9 — Income Taxes
The components of the provision for income taxes are as follows:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · For the Years Ended December 31, | ||||||
| | 2023 | 2022 | ||||
| Current taxes: | | | | | | |
| U.S. federal | $4,691,517 | $2,936,394 | ||||
| State | | | 1,273,073 | | | 349,669 |
| Foreign | | | 2,835 | | | 1,789 |
| Total current tax expense | | | 5,967,425 | | | 3,287,852 |
| Deferred taxes: | | | | | | |
| U.S. federal | | | (1,195,888) | | | (105,068) |
| State | | | (226,057) | | | 169,478 |
| Total deferred tax expense | | | (1,421,945) | | | 64,410 |
| Provision for income tax expense | $4,545,480 | $3,352,262 | ||||
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. The significant components of the deferred tax assets and liabilities were as follows:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · As of December 31, | ||||||
| | 2023 | 2022 | ||||
| Deferred income tax assets (liabilities): | | | | | | |
| Stock compensation | $163,084 | $227,682 | ||||
| Deferred revenue | | | 756,267 | | | 533,600 |
| Reserves and allowances | | | 607,273 | | | 258,016 |
| Depreciation and amortization | | | (495,359) | | | (400,869) |
| Accrued expenses | | | — | | | (16,565) |
| Capitalized Research and Development | | | 1,091,003 | | | — |
| Other, net | | | 548 | | | 99,005 |
| Total deferred income taxes, net | $2,122,816 | $700,869 | ||||
A reconciliation of the statutory U.S. federal tax rate to our effective rate is as follows:
| · · · · · | |||
|---|---|---|---|
| · · For the Years Ended December 31, | |||
| · 2023 · 2022 | |||
| Statutory U.S. federal tax rate | 21.0% | 21.0% | |
| CARES Act NOL carryback | — | (0.1) | |
| Stock compensation expense and tax windfalls upon exercises and vesting | (0.9) | (0.7) | |
| State taxes, net of federal benefit | 4.8 | 3.2 | |
| Permanent items | 0.4 | 0.4 | |
| Provision to return adjustments, net | (1.7) | (0.3) | |
| Foreign derived intangible income | (1.8) | (1.3) | |
| Research and development credits | (1.2) | (1.1) | |
| Other | 0.2 | (0.4) | |
| Effective rate | 20.8% | 20.7% | |
As of December 31, 2023 and December 31, 2022, we did not identify or accrue for any uncertain tax positions. We are currently not aware of any uncertain tax positions that could result in significant payments, accruals or other material deviations in this estimate over the next 12 months.
The Company does not have any outstanding U.S. federal income tax or material state and local tax matters for years through 2023. There are no federal income tax returns currently under examination by the Internal Revenue Service. The Company remains subject to income tax examinations for our United States Federal and certain U.S. state income taxes for 2020 and subsequent years and various other U.S. state income taxes for 2019 and subsequent years.
A valuation allowance is provided when it is more likely than not that some portion of the deferred tax asset will not be realized. Management has evaluated the need for a valuation allowance for deferred tax assets, considering the reversal of temporary differences, and believes it is more likely than not that the Company will realize the net deferred income tax assets as of December 31, 2023.
10 — Leases
We have entered into operating lease contracts for our plant and office space and various office equipment. We have three material lease contracts outstanding.
In January 2014, we entered into a non-cancelable operating lease, commencing July 1, 2014, for our manufacturing and headquarters facility in Winter Springs, Florida owned by Susi, LLC, an entity controlled by our President, Chief Executive Officer, and Chairman of the Board, Roger Susi. Pursuant to the terms of our lease for this property, the monthly base rent is $34,133, adjusted annually for changes in the consumer price index. For the year ended December 31, 2023 and 2022, the Company paid Susi, LLC $626,239 and $492,643 respectively related to this lease. Under the terms of the lease, we are responsible for property taxes, insurance and maintenance expenses. Prior to May 31, 2019, the expiration date of the initial lease term, and pursuant to the terms of the lease contract, we renewed the lease for an additional five years, resulting in a new lease expiration date of May 31, 2024. Unless advance written notice of termination is timely provided, the lease will automatically renew forone additional successive term offive years beginning in 2024, and thereafter, will be renewed for successive terms ofone year each. At the time we adopted ASU 2016-02, Leases (Topic 842), we concluded that we will exercise the remaining five-year option, resulting in a remaining lease term of 6.2 years as of December 31, 2023. This lease agreement does not contain anyresidual value guarantee or material restrictive covenants.
In February 2023, we entered intotwo, two-year, non-cancelable operating leases for approximately 5,400 square feet of additional office space in Winter Springs, Florida. Pursuant to the lease terms the total monthly base rent is $10,055. For the twelve months ended December 31, 2023, and 2022, the Company paid $110,605 and $0 respectively. Under the terms of the lease, we are responsible for insurance and maintenance expenses. Pursuant to the contract terms, the leases will expire February 2025 and do not contain any residual value guarantee or material restrictive covenants.
Operating lease cost recognized in the Statements of Operations is as follows:
| · · · · · · · · | ||||||
|---|---|---|---|---|---|---|
| · · For the Year Ended | ||||||
| · · · · December 31, | ||||||
| · · · 2023 · · 2022 | ||||||
| Cost of revenue | | | $233,101 | $223,880 | ||
| General and administrative | | | | 392,901 | | 263,346 |
| Sales and marketing | | | | 13,045 | | 12,529 |
| Research and development | | | | 36,143 | | 34,713 |
| Total | | | | $675,190 | | $534,468 |
Lease costs for short-term leases were immaterial for the years ended December 31, 2023 and 2022.
Maturity of Operating lease liability as of December 31, 2023, is as follows:
| · · · | ||
|---|---|---|
| Three months ending December 31, 2023 | $— | |
| 2024 | | 535,954 |
| 2025 | | 415,294 |
| 2026 | | 409,596 |
| 2027 | | 409,596 |
| Thereafter | | 596,127 |
| Total lease payments | | 2,366,567 |
| Imputed interest | | (323,524) |
| Present value of lease liability | | $2,043,043 |
We used a discount rate of 6.0% to determine the present value of the operating lease liability on January 1, 2019. We will reassess the lease accounting terms and assumptions once the details regarding completion of new manufacturing facility and planned departure of the current facility is finalized.
11 — Employee Benefit Plan
We sponsor a 401(k) tax-deferred savings plan under which eligible employees may elect to have a portion of their salary deferred and contributed to the plan. Employer matching contributions are determined by management and are discretionary. Employer matching contributions were $540,503 and $479,155 for the year ended December 31, 2023, and 2022, respectively. Employer contributions vest immediately.
12 — Commitments and Contingencies
Purchase commitments. We had various purchase orders for goods or services totaling approximately $8,217,571 and $8,021,403 as of December 31, 2023 and 2022, respectively. No amounts related to these purchase orders have been recognized in our balance sheet.
Indemnifications. Under our amended and restated bylaws, we have agreed to indemnify our officers and directors for certain events or occurrences arising as a result of the officer or director serving in such capacity. We have a director and officer liability insurance policy that limits our exposure under these indemnifications and enables us to recover a portion of any future loss arising out of them.
In addition, in the normal course of business, we enter into contracts that contain indemnification clauses whereby the Company indemnifies our customers against damages associated with product failures. We have determined that these agreements fall within the scope of ASC 460,Guarantees. We have obtained liability insurance providing coverage that limits our exposure for these indemnified matters. We have not incurred costs to defend lawsuits or settle claims related to these indemnities. We believe the estimated fair value of these indemnities is immaterial and have not recorded a liability for these agreements as of December 31, 2023.
Legal matters. We may from time to time become a party to various legal proceedings or claims that arise in the ordinary course of business.
13 — Capital Stock
The rights and privileges of our Series A Preferred Stock and Common Stock are as follows:
Series A Preferred Stock
We are authorized to issue 3,500,000 shares of preferred stock, of which 800,000 of these shares shall be designated as Series A Preferred Stock (“Preferred Stock”) with a par value of $0.0001 per share. As of December 31, 2023, there wasno preferred stock issued oroutstanding.
Voting and Dividends. The holder of each share of Preferred Stock has the right toone vote for each share of Common Stock into which such Preferred Stock could then be converted. The holders of the Preferred Stock are entitled to receive dividends from legally available assets prior to any declaration or payment of dividends to the holders of Common Stock. Dividends on each share of Preferred Stock are initially at $0.06429 per year payable when and as declared by the Board and are non-cumulative. After payment of such dividends, any additional dividends or distributions are distributed among all holders of Common Stock and Preferred Stock in proportion to the number of shares of Common Stock that would be held by each holder if all shares of Preferred Stock were converted to Common Stock at the then effective conversion rate. To date, no dividends have been declared.
Liquidation. In the event of any liquidation, dissolution or winding up of our Company, either voluntary or involuntary, the holders of the Preferred Stock are entitled to receive, prior and in preference to any distribution of the proceeds resulting from such liquidation event to holders of the Common Stock, an amount equal to $1.07143 plus declared but unpaid dividends. If, upon occurrence of such liquidation event, the proceeds are insufficient to permit the payment of the aforementioned amount in full, then the entire proceeds shall be distributed ratably among all holders of the Preferred Stock in proportion to the full amount each holder would otherwise receive.
*Conversion.*Each share of Preferred Stock is convertible at any time, at the option of the holder, into such number of fully paid non-assessable shares of Common Stock as is determined by dividing the original issue price of each share of Preferred Stock by the applicable conversion price. The initial conversion price per share is $1.07143. Adjustments to the initial conversion price may result from a recapitalization event or changes in the number of common shares outstanding. Each share of Preferred Stock automatically converts into shares of fully paid non-assessable shares of Common Stock, at the then applicable conversion rate, upon the date specified by written consent or agreement of the holders of a majority of the then outstanding shares of Preferred Stock, voting as a single class on an as-converted basis.
Redemption. Upon a majority vote of the then outstanding shares of Preferred Stock, we may, at our discretion, redeem or purchase shares of Preferred Stock. We also have a first right of refusal to repurchase shares of the Preferred Stock arising from a holder’s proposal to sell such Preferred Stock.
Common Stock
We are authorized to issue 31,500,000 shares of Common Stock with a par value of $0.0001 per share.
Voting and Dividends. Each outstanding share of Common Stock shall entitle the holder thereof toone vote on each matter properly submitted to the stockholders of the Company for their vote except for matters related to potential amendments to our Certificate of Incorporation or matters that solely relate to the terms of one or more outstanding series of our Preferred Stock. Holders of our Common Stock are entitled to receive, when, as and if declared by the Board, dividends pro rata based on the number of shares of Common Stock held. These dividend rights are junior to those of the holders of Preferred Stock.
Liquidation. Liquidation preference to the holders of Common Stock is junior to that of the holders of Preferred Stock.
Redemption. The Common Stock is not redeemable.
14 — Subsequent Events
On December 12, 2023, the Board of Directors declared a special cash dividend of$0.48 per share and the initiation of a regular quarterly dividend of$0.15 per share on the Company's outstanding common stock. The payment of both declarations was made on January 12, 2024, when we paid$7,975,997 to shareholders of record at the close of business on December 18, 2023.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.