Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2022 | Oct. 31, 2022 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 001-36534 | |
Entity Registrant Name | IRADIMED CORPORATION | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 73-1408526 | |
Entity Address, Address Line One | 1025 Willa Springs Drive | |
Entity Address, City or Town | Winter Springs | |
Entity Address, State or Province | FL | |
Entity Address, Postal Zip Code | 32708 | |
City Area Code | 407 | |
Local Phone Number | 677-8022 | |
Title of 12(b) Security | Common stock, par value $0.0001 | |
Trading Symbol | IRMD | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 12,566,336 | |
Entity Central Index Key | 0001325618 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 55,592,152 | $ 61,999,550 |
Investments | 501,855 | |
Accounts receivable, net of allowance for doubtful accounts of $113,850 as of September 30, 2022, and $60,361 as of December 31, 2021 | 10,651,264 | 5,136,599 |
Inventory, net | 5,243,256 | 4,299,799 |
Prepaid expenses and other current assets | 386,634 | 1,000,716 |
Prepaid income taxes | 3,306,438 | |
Total current assets | 71,873,306 | 76,244,957 |
Property and equipment, net | 2,292,516 | 2,069,376 |
Intangible assets, net | 1,881,137 | 1,118,584 |
Operating lease right-of-use asset, net | 2,276,089 | 2,482,084 |
Deferred income taxes, net | 985,097 | 765,096 |
Other assets | 236,188 | 201,325 |
Total assets | 79,544,333 | 82,881,422 |
Current liabilities: | ||
Accounts payable | 964,360 | 782,903 |
Accrued payroll and benefits | 2,349,772 | 2,814,560 |
Other accrued taxes | 181,877 | 140,315 |
Warranty reserve | 95,287 | 108,880 |
Deferred revenue | 1,586,256 | 2,553,096 |
Current portion of operating lease liability | 289,147 | 276,568 |
Other current liabilities | 136,927 | 146,435 |
Total current liabilities | 5,603,626 | 6,822,757 |
Deferred revenue | 2,182,494 | 1,679,343 |
Operating lease liability, less current portion | 1,986,942 | 2,205,516 |
Total liabilities | 9,773,062 | 10,707,616 |
Stockholders' equity: | ||
Common stock; $0.0001 par value; 31,500,000 shares authorized; 12,565,290 shares issued and outstanding as of September 30, 2022, and 12,544,024 shares issued and outstanding as of December 31, 2021 | 1,256 | 1,254 |
Additional paid-in capital | 26,179,351 | 25,160,618 |
Retained earnings | 43,590,664 | 46,994,922 |
Accumulated other comprehensive income | 17,012 | |
Total stockholders' equity | 69,771,271 | 72,173,806 |
Total liabilities and stockholders' equity | $ 79,544,333 | $ 82,881,422 |
CONDENSED BALANCE SHEETS (Paren
CONDENSED BALANCE SHEETS (Parenthetical) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
CONDENSED BALANCE SHEETS | ||
Accounts receivable, net of allowance for doubtful accounts | $ 113,850 | $ 60,361 |
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 31,500,000 | 31,500,000 |
Common stock, shares issued | 12,565,290 | 12,544,024 |
Common stock, shares outstanding | 12,561,025 | 12,544,024 |
CONDENSED STATEMENTS OF OPERATI
CONDENSED STATEMENTS OF OPERATIONS - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
CONDENSED STATEMENTS OF OPERATIONS | ||||
Revenue | $ 13,407,272 | $ 10,907,302 | $ 38,439,551 | $ 29,941,721 |
Cost of revenue | 2,864,534 | 2,501,745 | 8,377,526 | 7,141,547 |
Gross profit | 10,542,738 | 8,405,557 | 30,062,025 | 22,800,174 |
Operating expenses: | ||||
General and administrative | 2,881,590 | 2,252,274 | 8,000,335 | 7,247,262 |
Sales and marketing | 3,037,209 | 2,585,702 | 9,014,553 | 7,434,603 |
Research and development | 491,643 | 480,696 | 1,673,337 | 1,410,192 |
Total operating expenses | 6,410,442 | 5,318,672 | 18,688,225 | 16,092,057 |
Income from operations | 4,132,296 | 3,086,885 | 11,373,800 | 6,708,117 |
Other income , net | 105,183 | 7,143 | 103,371 | 14,675 |
Income before provision for income taxes | 4,237,479 | 3,094,028 | 11,477,171 | 6,722,792 |
Provision for income tax expense | 810,375 | 517,767 | 2,322,301 | 1,289,988 |
Net income | $ 3,427,104 | $ 2,576,261 | $ 9,154,870 | $ 5,432,804 |
Net income per share: | ||||
Basic | $ 0.27 | $ 0.21 | $ 0.73 | $ 0.44 |
Diluted | $ 0.27 | $ 0.20 | $ 0.72 | $ 0.43 |
Weighted average shares outstanding: | ||||
Basic | 12,564,636 | 12,331,062 | 12,559,465 | 12,318,476 |
Diluted | 12,631,129 | 12,603,566 | 12,637,325 | 12,570,925 |
CONDENSED STATEMENTS OF COMPREH
CONDENSED STATEMENTS OF COMPREHENSIVE INCOME - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
CONDENSED STATEMENTS OF COMPREHENSIVE INCOME | ||||
Net income | $ 3,427,104 | $ 2,576,261 | $ 9,154,870 | $ 5,432,804 |
Other comprehensive (loss) income: | ||||
Change in fair value of available-for-sale securities, net of tax expense (benefit) of $0 and $(944) for the three months ended September 30, 2022 and 2021, respectively, and $9,098 and $(8,275) for the nine months ended September 30, 2022 and 2021, respectively | (2,948) | (10,953) | (6,027) | |
Realized gain on available-for-sale securities reclassified to net income, net of tax expense of $0 and $0 for the three months ended September 30, 2022, and 2021, respectively, and $1,966 and $3,176 for the nine months ended September 30, 2022, and 2021, respectively | (6,059) | (9,829) | ||
Other comprehensive (loss) | (2,948) | (17,012) | (15,856) | |
Comprehensive income | $ 3,427,104 | $ 2,573,313 | $ 9,137,858 | $ 5,416,948 |
CONDENSED STATEMENTS OF COMPR_2
CONDENSED STATEMENTS OF COMPREHENSIVE INCOME (Parenthetical) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
CONDENSED STATEMENTS OF COMPREHENSIVE INCOME | ||||
Change in fair value of available-for-sale securities, net of tax expense (benefit) | $ 0 | $ (944) | $ 9,098 | $ (8,275) |
Realized gain on available-for-sale securities reclassified to net income, net of tax expense | $ 0 | $ 0 | $ 1,966 | $ 3,176 |
CONDENSED STATEMENTS OF STOCKHO
CONDENSED STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) | Common Stock | Additional Paid-In Capital | Retained Earnings | Accumulated Other Comprehensive Income | Total |
Balances at Dec. 31, 2020 | $ 1,231 | $ 23,676,843 | $ 37,669,451 | $ 37,087 | $ 61,384,612 |
Balance (in shares) at Dec. 31, 2020 | 12,308,432 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net income | 1,386,849 | 1,386,849 | |||
Other comprehensive loss | (4,869) | (4,869) | |||
Stock-based compensation expense | 347,741 | 347,741 | |||
Net share settlement of restricted stock units | (38,707) | (38,707) | |||
Net share settlement of restricted stock units (in shares) | 3,502 | ||||
Exercise of stock options | 2,460 | 2,460 | |||
Exercise of stock options (in shares) | 250 | ||||
Balances at Mar. 31, 2021 | $ 1,231 | 23,988,337 | 39,056,300 | 32,218 | 63,078,086 |
Balance (in shares) at Mar. 31, 2021 | 12,312,184 | ||||
Balances at Dec. 31, 2020 | $ 1,231 | 23,676,843 | 37,669,451 | 37,087 | 61,384,612 |
Balance (in shares) at Dec. 31, 2020 | 12,308,432 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net income | 5,432,804 | ||||
Balances at Sep. 30, 2021 | $ 1,234 | 24,766,697 | 43,102,255 | 21,231 | 67,891,417 |
Balance (in shares) at Sep. 30, 2021 | 12,340,654 | ||||
Balances at Mar. 31, 2021 | $ 1,231 | 23,988,337 | 39,056,300 | 32,218 | 63,078,086 |
Balance (in shares) at Mar. 31, 2021 | 12,312,184 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net income | 1,469,694 | 1,469,694 | |||
Other comprehensive loss | (8,039) | (8,039) | |||
Stock-based compensation expense | 358,012 | 358,012 | |||
Net share settlement of restricted stock units | $ 1 | (15,875) | (15,874) | ||
Net share settlement of restricted stock units (in shares) | 2,727 | ||||
Exercise of stock options | 20,235 | 20,235 | |||
Exercise of stock options (in shares) | 2,125 | ||||
Balances at Jun. 30, 2021 | $ 1,232 | 24,350,709 | 40,525,994 | 24,179 | 64,902,114 |
Balance (in shares) at Jun. 30, 2021 | 12,317,036 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net income | 2,576,261 | 2,576,261 | |||
Other comprehensive loss | (2,948) | (2,948) | |||
Stock-based compensation expense | 361,836 | 361,836 | |||
Net share settlement of restricted stock units | (8,766) | (8,766) | |||
Net share settlement of restricted stock units (in shares) | 618 | ||||
Exercise of stock options | $ 2 | 62,918 | 62,920 | ||
Exercise of stock options (in shares) | 23,000 | ||||
Balances at Sep. 30, 2021 | $ 1,234 | 24,766,697 | 43,102,255 | 21,231 | 67,891,417 |
Balance (in shares) at Sep. 30, 2021 | 12,340,654 | ||||
Balances at Dec. 31, 2021 | $ 1,254 | 25,160,618 | 46,994,922 | 17,012 | 72,173,806 |
Balance (in shares) at Dec. 31, 2021 | 12,544,024 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net income | 2,486,713 | 2,486,713 | |||
Dividends paid | (12,559,127) | (12,559,127) | |||
Other comprehensive loss | (10,885) | (10,885) | |||
Stock-based compensation expense | 453,360 | 453,360 | |||
Net share settlement of restricted stock units | $ 1 | (67,381) | (67,380) | ||
Net share settlement of restricted stock units (in shares) | 3,879 | ||||
Exercise of stock options | $ 1 | 71,947 | 71,948 | ||
Exercise of stock options (in shares) | 12,566 | ||||
Balances at Mar. 31, 2022 | $ 1,256 | 25,618,544 | 36,922,508 | 6,127 | 62,548,435 |
Balance (in shares) at Mar. 31, 2022 | 12,560,469 | ||||
Balances at Dec. 31, 2021 | $ 1,254 | 25,160,618 | 46,994,922 | 17,012 | 72,173,806 |
Balance (in shares) at Dec. 31, 2021 | 12,544,024 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net income | 9,154,870 | ||||
Balances at Sep. 30, 2022 | $ 1,256 | 26,179,351 | 43,590,664 | 69,771,271 | |
Balance (in shares) at Sep. 30, 2022 | 12,565,290 | ||||
Balances at Mar. 31, 2022 | $ 1,256 | 25,618,544 | 36,922,508 | 6,127 | 62,548,435 |
Balance (in shares) at Mar. 31, 2022 | 12,560,469 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net income | 3,241,052 | 3,241,052 | |||
Other comprehensive loss | $ (6,127) | (6,127) | |||
Stock-based compensation expense | 121,003 | 121,003 | |||
Net share settlement of restricted stock units | (5,726) | (5,726) | |||
Net share settlement of restricted stock units (in shares) | 556 | ||||
Balances at Jun. 30, 2022 | $ 1,256 | 25,733,821 | 40,163,560 | 65,898,637 | |
Balance (in shares) at Jun. 30, 2022 | 12,561,025 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Net income | 3,427,104 | 3,427,104 | |||
Stock-based compensation expense | 393,187 | 393,187 | |||
Net share settlement of restricted stock units | (22,417) | (22,417) | |||
Net share settlement of restricted stock units (in shares) | 1,265 | ||||
Exercise of stock options | 74,760 | 74,760 | |||
Exercise of stock options (in shares) | 3,000 | ||||
Balances at Sep. 30, 2022 | $ 1,256 | $ 26,179,351 | $ 43,590,664 | $ 69,771,271 | |
Balance (in shares) at Sep. 30, 2022 | 12,565,290 |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS - USD ($) | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Operating activities: | ||
Net income | $ 9,154,870 | $ 5,432,804 |
Adjustments to reconcile net income to net cash provided by operating activities: | ||
Change in allowance for doubtful accounts | 56,118 | (567) |
Change in provision for excess and obsolete inventory | 29,227 | 51,731 |
Depreciation and amortization | 1,363,578 | 1,020,223 |
(Gain) loss on disposal of property and equipment | (3,000) | 1,066 |
Stock-based compensation | 967,551 | 1,067,589 |
Deferred income taxes, net | (227,133) | 414,095 |
Loss on maturities of investments | (8,025) | (13,005) |
Changes in operating assets and liabilities: | ||
Accounts receivable | (5,570,783) | 321,852 |
Inventory | (903,792) | (344,721) |
Prepaid expenses and other current assets | (306,031) | (663,408) |
Other assets | 6,660 | 23,447 |
Accounts payable | 37,338 | (17,076) |
Accrued payroll and benefits | (464,788) | 699,204 |
Other accrued taxes | 3,395 | (12,727) |
Warranty reserve | (13,593) | 20,953 |
Deferred revenue | (452,822) | 313,381 |
Other current liabilities | (9,508) | |
Prepaid income taxes | 3,344,605 | (422,728) |
Net cash provided by operating activities | 7,003,867 | 7,892,113 |
Investing activities: | ||
Proceeds from maturities of investments | 500,000 | 950,000 |
Purchases of property and equipment | (564,883) | (391,303) |
Capitalized intangible assets | (838,438) | (170,234) |
Net cash (used in) provided by investing activities | (903,321) | 388,463 |
Financing activities: | ||
Dividends paid | (12,559,127) | |
Proceeds from exercises of stock options | 146,707 | 85,615 |
Taxes paid related to the net share settlement of equity awards | (95,523) | (63,347) |
Net cash (used in) provided by financing activities | (12,507,943) | 22,268 |
Net (decrease) increase in cash and cash equivalents | (6,407,398) | 8,302,844 |
Cash and cash equivalents, beginning of period | 61,999,550 | 50,068,728 |
Cash and cash equivalents, end of period | 55,592,152 | 58,371,572 |
Supplemental disclosure of cash flow information: | ||
Cash paid for income taxes | 757,137 | 1,283,722 |
ROU asset recognized in exchange for new lease obligation | 0 | 27,713 |
Operating and short-term lease payments recorded within cash flow provided by operating activities | $ 364,825 | $ 364,545 |
Basis of Presentation
Basis of Presentation | 9 Months Ended |
Sep. 30, 2022 | |
Basis of Presentation | |
Basis of Presentation | 1 — Basis of Presentation The accompanying interim condensed financial statements of IRADIMED CORPORATION (“IRADIMED”, the “Company”, “we”, “our”) have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”). Certain information and footnote disclosures normally presented in annual financial statements prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) have been condensed or omitted pursuant to such rules and regulations. The interim financial information is unaudited, but reflects all normal adjustments that are, in the opinion of management, necessary for the fair presentation of our financial position, results of operations and cash flows for the interim periods presented. Operating results for the three and nine months ended September 30, 2022 are not necessarily indicative of the results that may be expected for the year ending December 31, 2022, and other interim periods, or future years or periods. The accompanying interim condensed financial statements should be read in conjunction with the financial statements and related footnotes to financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2021. The accounting policies followed in the preparation of these interim condensed financial statements, except as described in Note 1, are consistent in all material respects with those described in Note 1 of our Form 10-K. We operate in one reportable segment which is the development, manufacture and sale of Magnetic Resonance Imaging (“MRI”) compatible medical devices, related accessories, disposables and service for use primarily by hospitals and acute care facilities during MRI procedures. 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 regularly throughout the year. We have not incurred any losses related to these balances. Our medical devices require clearance from the FDA 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. COVID-19 Considerations The worldwide COVID-19 pandemic has negatively impacted, and may continue to negatively impact, the macroeconomic environment in the United States and globally. From the beginning of this global health crisis, our priority has been the safety and well-being of our employees and continuing to supply our customers with access to our therapeutic and diagnostic device solutions. Due to the evolving and uncertain nature of COVID-19, it is reasonably possible that it could materially impact our estimates, particularly those that require consideration of forecasted financial information, in the near to medium term. These estimates relate to certain accounts including, but not limited to, intangible assets, and other long-lived assets. The magnitude of the impact will depend on numerous evolving factors that we may not be able to accurately predict, including the duration and extent of the pandemic, the impact of federal, state, local and foreign governmental actions, consumer, supplier and hospital behavior in response to the pandemic and such governmental actions, and the economic and operating conditions that we may face in the aftermath of COVID-19. Environmental, Social, and Governance (“ESG”) Related Matters ESG related matters have received increased focus recently from investors, employees, ratings agencies, governmental agencies, and other stakeholders. Government agencies and listing exchanges have mandated or proposed, and others may in the future further mandate certain ESG requirements and disclosures. For example, the SEC has recently proposed additional disclosures regarding, among other items, the impact businesses have on the environment. The SEC proposed rule would require companies to make certain climate-related disclosures, including information about climate-related risks, greenhouse gas emissions and certain climate-related financial statement metrics. We may face increased scrutiny related to any third-party sustainability ratings we receive and our ESG activities, our related disclosures and/or our failure to achieve progress in these areas on a timely basis, or at all, could adversely affect our reputation, business, and results of operations. To the extent the SEC proposal becomes effective, we will be required to establish additional internal controls, engage additional consultants, and incur additional costs related to measuring and evaluating our environmental impact and preparing such disclosures. If we fail to implement sufficient internal controls or accurately capture and disclose relevant data concerning our ESG activities, our reputation, business, financial condition, and results of operations may be materially adversely affected. Recent Accounting Pronouncements 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 Codification Improvements to Topic 326, Financial Instruments - Credit Losses Codification Improvements to Topic 326, Financial Instruments - Credit Losses Financial Instruments - Credit Losses (Topic 326): Targeted Transition Relief |
Revenue Recognition
Revenue Recognition | 9 Months Ended |
Sep. 30, 2022 | |
Revenue Recognition | |
Revenue Recognition | 2 — Revenue Recognition 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: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 (unaudited) (unaudited) United States $ 10,810,370 $ 8,676,488 $ 31,606,401 $ 23,992,474 International 2,596,902 2,230,814 6,833,150 5,949,247 Total revenue $ 13,407,272 $ 10,907,302 $ 38,439,551 $ 29,941,721 Revenue information by type is as follows: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 (unaudited) (unaudited) Devices: MRI Compatible IV Infusion Pump Systems $ 3,866,535 $ 3,369,068 $ 11,001,490 $ 9,329,182 MRI Compatible Patient Vital Signs Monitoring Systems 5,519,045 3,779,442 15,635,415 9,760,991 Ferro Magnetic Detection Systems 62,982 — 62,982 — Total Devices revenue 9,448,562 7,148,510 26,699,887 19,090,173 Disposables, services and other 3,410,015 3,285,656 10,158,922 9,412,091 Amortization of extended warranty agreements 548,695 473,136 1,580,742 1,439,457 Total revenue $ 13,407,272 $ 10,907,302 $ 38,439,551 $ 29,941,721 Contract Liabilities Our contract liabilities consist of: September 30, December 31, 2022 2021 (unaudited) Advance payments from customers $ 184,653 $ 551,267 Shipments in-transit 10,867 70,295 Extended warranty agreements 3,573,230 3,610,877 Total $ 3,768,750 $ 4,232,439 Changes in the contract liabilities during the periods presented are as follows: Deferred Revenue Contract liabilities, December 31, 2021 $ 4,232,439 Increases due to cash received from customers 2,927,868 Decreases due to recognition of revenue (3,391,557) Contract liabilities, September 30, 2022 $ 3,768,750 Deferred Revenue Contract liabilities, December 31, 2020 $ 4,254,672 Increases due to cash received from customers 3,617,619 Decreases due to recognition of revenue (3,519,193) Contract liabilities, September 30, 2021 $ 4,353,098 Capitalized Contract Costs Our capitalized contract costs totaled $351,150 and $357,810 as of September 30, 2022 and December 31, 2021, respectively, and are classified as other assets on the balance sheet. |
Basic and Diluted Net Income pe
Basic and Diluted Net Income per Share | 9 Months Ended |
Sep. 30, 2022 | |
Basic and Diluted Net Income per Share | |
Basic and Diluted Net Income per Share | 3 — Basic and Diluted Net Income per Share Basic net income per share is based upon 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. 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: Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 (unaudited) (unaudited) Net income $ 3,427,104 $ 2,576,261 $ 9,154,870 $ 5,432,804 Weighted-average shares outstanding — Basic 12,564,636 12,331,062 12,559,465 12,318,476 Effect of dilutive securities: Stock options 18,196 187,737 21,198 191,439 Restricted stock units 48,297 84,767 56,662 61,010 Weighted-average shares outstanding — Diluted 12,631,129 12,603,566 12,637,325 12,570,925 Basic net income per share $ 0.27 $ 0.21 $ 0.73 $ 0.44 Diluted net income per share $ 0.27 $ 0.20 $ 0.72 $ 0.43 Stock options 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: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 (unaudited) (unaudited) Anti-dilutive stock options and restricted stock units 26,402 164 31,254 2,644 |
Inventory, net
Inventory, net | 9 Months Ended |
Sep. 30, 2022 | |
Inventories, net | |
Inventory, net | 4 — Inventory, net Inventory consists of: September 30, December 31, 2022 2021 (unaudited) Raw materials $ 4,715,981 $ 3,777,846 Work in process 337,217 191,722 Finished goods 402,835 513,782 Inventory before allowance for excess and obsolete 5,456,033 4,483,350 Allowance for excess and obsolete (212,777) (183,551) Total $ 5,243,256 $ 4,299,799 |
Property and Equipment, net
Property and Equipment, net | 9 Months Ended |
Sep. 30, 2022 | |
Property and Equipment, net | |
Property and Equipment, net | 5 — Property and Equipment, net Property and equipment consist of: September 30, December 31, 2022 2021 (unaudited) Computer software and hardware $ 1,062,468 $ 837,826 Furniture and fixtures 1,503,426 1,252,434 Leasehold improvements 257,786 237,086 Machinery and equipment 2,110,769 2,066,003 Tooling in-process 639,053 537,043 5,573,502 4,930,392 Accumulated depreciation (3,280,986) (2,861,016) Total $ 2,292,516 $ 2,069,376 Depreciation expense of property and equipment was $142,389 and $131,541 for the three months ended September 30, 2022 and 2021, respectively, and $419,970 and $396,278 for the nine months ended September 30, 2022 and 2021, respectively. Property and equipment, net, information by geographic region is as follows: September 30, December 31, 2022 2021 (unaudited) United States $ 2,142,195 $ 1,855,012 International 150,321 214,364 Total property and equipment, net $ 2,292,516 $ 2,069,376 Long-lived assets held outside of the United States consist principally of tooling and machinery and equipment, which are components of property and equipment, net. |
Intangible Assets, net
Intangible Assets, net | 9 Months Ended |
Sep. 30, 2022 | |
Intangible Assets, net | |
Intangible Assets, net | 6 — Intangible Assets, net The following table summarizes the components of intangible asset balances: September 30, December 31, 2022 2021 (unaudited) Patents — in use $ 392,037 $ 372,502 Patents — in process 96,575 111,593 Internally developed software — in use 872,218 872,218 Internally developed software — in process 1,302,362 468,441 Trademarks 27,697 27,697 2,690,889 1,852,451 Accumulated amortization (809,752) (733,867) Total $ 1,881,137 $ 1,118,584 Amortization expense of intangible assets was $25,236 and $25,256 for the three months ended September 30, 2022 and 2021, respectively, and $75,886 and $76,478 for the nine months ended September 30, 2022 and 2021, respectively. Expected annual amortization expense for the remaining portion of 2022 and the next five years related to intangible assets is as follows (excludes in process intangible assets): Three months ending December 31, 2022 $ 25,236 2023 $ 100,946 2024 $ 100,544 2025 $ 97,374 2026 $ 85,658 2027 $ 11,945 |
Investments
Investments | 9 Months Ended |
Sep. 30, 2022 | |
Investments | |
Investments | 7 — Investments Our investments consist of bonds that we have classified as available-for-sale and are summarized in the following tables: September 30, 2022 Gross Gross Unrealized Unrealized Fair Cost Gains Losses Value U.S. corporate bonds $ — $ — $ — $ — December 31, 2021 Gross Gross Unrealized Unrealized Fair Cost Gains Losses Value U.S. corporate bonds $ 491,975 $ 9,880 $ — $ 501,855 |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Measurements | |
Fair Value Measurements | 8 — Fair Value Measurements The fair values of cash equivalents, accounts receivables, net and accounts payable approximate their carrying amounts due to their short duration. The fair value of our assets and liabilities subject to recurring fair value measurements are as follows: Fair Value at September 30, 2022 Quoted Prices Significant in Active Other Significant Market for Observable Unobservable Fair Identical Assets Inputs Inputs Value (Level 1) (Level 2) (Level 3) U.S. treasury bills $ 39,690,640 $ — $ 39,690,640 $ — Fair Value at December 31, 2021 Quoted Prices Significant in Active Other Significant Market for Observable Unobservable Fair Identical Assets Inputs Inputs Value (Level 1) (Level 2) (Level 3) U.S. corporate bonds $ 501,855 $ — $ 501,855 $ — Our corporate bonds are valued by a third-party custodian at closing prices from secondary exchanges or pricing vendors on the valuation date. Our treasury bills are included as Cash and Cash Equivalents on the Balance Sheet since all highly liquid instruments purchased with an original maturity of three months or less are classified as cash equivalents. |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Income | 9 Months Ended |
Sep. 30, 2022 | |
Accumulated Other Comprehensive Income | |
Accumulated Other Comprehensive Income | 9 — Accumulated Other Comprehensive Income The components of accumulated other comprehensive income, net of tax, for the three months ended September 30, 2022 and 2021 are as follows: Unrealized (Losses) Gains on Available-For-Sale Securities Balance at June 30, 2022 $ — Loss on available-for-sale securities, net — Reclassification realized in net earnings — Balance at September 30, 2022 $ — Balance at June 30, 2021 $ 24,179 Gains on available-for-sale securities, net (2,948) Reclassification realized in net earnings — Balance at September 30, 2021 $ 21,231 The components of accumulated other comprehensive income, net of tax, for the nine months ended September 30, 2022 and 2021 are as follows: Unrealized (Losses) Gains on Available-For-Sale Securities Balance at December 31, 2021 $ 17,012 Loss on available-for-sale securities, net (10,953) Reclassification realized in net earnings (6,059) Balance at September 30, 2022 $ — Balance at December 31, 2020 $ 37,087 Loss on available-for-sale securities, net (6,027) Reclassification realized in net earnings (9,829) Balance at September 30, 2021 $ 21,231 |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Stock-Based Compensation | |
Stock-Based Compensation | 10 — Stock-Based Compensation Stock-based compensation was recognized as follows in the unaudited Condensed Statements of Operations: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 (unaudited) (unaudited) Cost of revenue $ 50,007 $ 68,227 $ 137,386 $ 177,375 General and administrative 186,293 152,261 393,668 513,319 Sales and marketing 116,255 96,210 315,929 269,505 Research and development 40,633 45,138 120,568 107,390 Total $ 393,188 $ 361,836 $ 967,551 $ 1,067,589 As of September 30, 2022, we had $2,749,903 of unrecognized compensation cost related to unvested restricted stock units, which is expected to be recognized over a weighted-average period of 2.65 years. As of September 30, 2022, we had $251,841 of unrecognized compensation cost related to unvested performance-based restricted stock units, which is expected to be recognized over a weighted-average period of 1.99 years. The following table presents a summary of our stock-based compensation activity for the nine months ended September 30, 2022 (shares): Performance Based Stock Restricted Restricted Options Stock Units Stock Units Outstanding beginning of period 39,576 131,182 18,301 Awards granted — 26,836 — Awards exercised/vested (15,566) (8,099) — Awards canceled/ forfeited — (27,691) (9,236) Outstanding end of period 24,010 122,228 9,065 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2022 | |
Income Taxes | |
Income Taxes | 11 — Income Taxes For the three and nine months ended September 30, 2022, we recorded a provision for income tax expense of $810,375 and $2,322,301, respectively. Our effective tax rate was 19.1 percent and 20.2 percent, respectively, and differed from the U.S. Federal statutory rate primarily due to U.S. state income tax expense, partially offset by benefits from foreign derived intangible income and research and development tax credits. For the three and nine months ended September 30, 2021, we recorded a provision for income tax expense of $517,767 and $1,289,988, respectively. Our effective tax rate was 16.7 percent and 19.2 percent, respectively, and differed from the U.S. Federal statutory rate primarily due to U.S. state income tax expense, partially offset by benefits from foreign derived intangible income and research and development tax credits. As of September 30, 2022 and December 31, 2021, we had not identified or accrued for any uncertain tax positions. We are currently unaware of any uncertain tax positions that could result in significant payments, accruals, or other material deviations in this estimate over the next 12 months. We believe that our tax positions comply in all material respects with applicable tax law. However, tax law is subject to interpretation, and interpretations by taxing authorities could be different from ours, which could result in the imposition of additional taxes and penalties. We file tax returns in the United States Federal jurisdiction and many U.S. state jurisdictions. Our returns are not 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 2019 and subsequent years. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2022 | |
Leases | |
Leases | 12 — Leases We have entered into operating lease contracts for our office and various office equipment. We have one material lease contract 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 nine months ended September 30, 2022 and 2021, the Company paid Susi, LLC $364,825 and $347,643 respectively. For the year ended December 31, 2021, the Company paid Susi, LLC $461,874 related to this lease. Under the terms of the lease, we are responsible for 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 for one additional successive term of five years beginning in 2024, and thereafter, will be renewed for successive terms of one year each. At the time we adopted ASU 2016-02, Leases five-year residual value guarantee Operating lease cost recognized in the unaudited Condensed Statements of Operations is as follows: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 (unaudited) (unaudited) Cost of revenue $ 58,086 $ 53,854 $ 165,794 $ 156,043 General and administrative 57,474 54,710 164,046 158,672 Sales and marketing 3,251 3,014 9,279 8,733 Research and development 9,006 8,350 25,706 24,195 Total $ 127,817 $ 119,928 $ 364,825 $ 347,643 Lease costs for short-term leases were immaterial for the three and nine months ended September 30, 2022, and 2021. Maturity of our operating lease liability as of September 30, 2022, is as follows: Three months ending December 31, 2022 $ 103,823 2023 415,294 2024 415,294 2025 415,294 2026 411,008 Thereafter 989,857 Total lease payments 2,750,570 Imputed interest (474,366) Present value of lease liability $ 2,276,204 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2022 | |
Commitments and Contingencies | |
Commitments and Contingencies | 13 — Commitments and Contingencies Purchase commitments. Legal matters. Land acquisition. 30 |
Basis of Presentation (Policies
Basis of Presentation (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Basis of Presentation | |
Certain Significant Risks and Uncertainties | 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 regularly throughout the year. We have not incurred any losses related to these balances. Our medical devices require clearance from the FDA 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. COVID-19 Considerations The worldwide COVID-19 pandemic has negatively impacted, and may continue to negatively impact, the macroeconomic environment in the United States and globally. From the beginning of this global health crisis, our priority has been the safety and well-being of our employees and continuing to supply our customers with access to our therapeutic and diagnostic device solutions. Due to the evolving and uncertain nature of COVID-19, it is reasonably possible that it could materially impact our estimates, particularly those that require consideration of forecasted financial information, in the near to medium term. These estimates relate to certain accounts including, but not limited to, intangible assets, and other long-lived assets. The magnitude of the impact will depend on numerous evolving factors that we may not be able to accurately predict, including the duration and extent of the pandemic, the impact of federal, state, local and foreign governmental actions, consumer, supplier and hospital behavior in response to the pandemic and such governmental actions, and the economic and operating conditions that we may face in the aftermath of COVID-19. Environmental, Social, and Governance (“ESG”) Related Matters ESG related matters have received increased focus recently from investors, employees, ratings agencies, governmental agencies, and other stakeholders. Government agencies and listing exchanges have mandated or proposed, and others may in the future further mandate certain ESG requirements and disclosures. For example, the SEC has recently proposed additional disclosures regarding, among other items, the impact businesses have on the environment. The SEC proposed rule would require companies to make certain climate-related disclosures, including information about climate-related risks, greenhouse gas emissions and certain climate-related financial statement metrics. We may face increased scrutiny related to any third-party sustainability ratings we receive and our ESG activities, our related disclosures and/or our failure to achieve progress in these areas on a timely basis, or at all, could adversely affect our reputation, business, and results of operations. To the extent the SEC proposal becomes effective, we will be required to establish additional internal controls, engage additional consultants, and incur additional costs related to measuring and evaluating our environmental impact and preparing such disclosures. If we fail to implement sufficient internal controls or accurately capture and disclose relevant data concerning our ESG activities, our reputation, business, financial condition, and results of operations may be materially adversely affected. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements 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 Codification Improvements to Topic 326, Financial Instruments - Credit Losses Codification Improvements to Topic 326, Financial Instruments - Credit Losses Financial Instruments - Credit Losses (Topic 326): Targeted Transition Relief |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Revenue Recognition | |
Schedule of disaggregation of revenue by geographic region and revenue type | Revenue information by geographic region is as follows: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 (unaudited) (unaudited) United States $ 10,810,370 $ 8,676,488 $ 31,606,401 $ 23,992,474 International 2,596,902 2,230,814 6,833,150 5,949,247 Total revenue $ 13,407,272 $ 10,907,302 $ 38,439,551 $ 29,941,721 Revenue information by type is as follows: Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 (unaudited) (unaudited) Devices: MRI Compatible IV Infusion Pump Systems $ 3,866,535 $ 3,369,068 $ 11,001,490 $ 9,329,182 MRI Compatible Patient Vital Signs Monitoring Systems 5,519,045 3,779,442 15,635,415 9,760,991 Ferro Magnetic Detection Systems 62,982 — 62,982 — Total Devices revenue 9,448,562 7,148,510 26,699,887 19,090,173 Disposables, services and other 3,410,015 3,285,656 10,158,922 9,412,091 Amortization of extended warranty agreements 548,695 473,136 1,580,742 1,439,457 Total revenue $ 13,407,272 $ 10,907,302 $ 38,439,551 $ 29,941,721 |
Schedule of contract liabilities and changes in the contract liabilities | Our contract liabilities consist of: September 30, December 31, 2022 2021 (unaudited) Advance payments from customers $ 184,653 $ 551,267 Shipments in-transit 10,867 70,295 Extended warranty agreements 3,573,230 3,610,877 Total $ 3,768,750 $ 4,232,439 Changes in the contract liabilities during the periods presented are as follows: Deferred Revenue Contract liabilities, December 31, 2021 $ 4,232,439 Increases due to cash received from customers 2,927,868 Decreases due to recognition of revenue (3,391,557) Contract liabilities, September 30, 2022 $ 3,768,750 Deferred Revenue Contract liabilities, December 31, 2020 $ 4,254,672 Increases due to cash received from customers 3,617,619 Decreases due to recognition of revenue (3,519,193) Contract liabilities, September 30, 2021 $ 4,353,098 |
Basic and Diluted Net Income _2
Basic and Diluted Net Income per Share (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Basic and Diluted Net Income per Share | |
Schedule of computation of basic and diluted net income per share | Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 (unaudited) (unaudited) Net income $ 3,427,104 $ 2,576,261 $ 9,154,870 $ 5,432,804 Weighted-average shares outstanding — Basic 12,564,636 12,331,062 12,559,465 12,318,476 Effect of dilutive securities: Stock options 18,196 187,737 21,198 191,439 Restricted stock units 48,297 84,767 56,662 61,010 Weighted-average shares outstanding — Diluted 12,631,129 12,603,566 12,637,325 12,570,925 Basic net income per share $ 0.27 $ 0.21 $ 0.73 $ 0.44 Diluted net income per share $ 0.27 $ 0.20 $ 0.72 $ 0.43 |
Schedule of stock options and restricted stock units excluded from the calculation of diluted net income per share | Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 (unaudited) (unaudited) Anti-dilutive stock options and restricted stock units 26,402 164 31,254 2,644 |
Inventory, net (Tables)
Inventory, net (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Inventories, net | |
Schedule of inventory | September 30, December 31, 2022 2021 (unaudited) Raw materials $ 4,715,981 $ 3,777,846 Work in process 337,217 191,722 Finished goods 402,835 513,782 Inventory before allowance for excess and obsolete 5,456,033 4,483,350 Allowance for excess and obsolete (212,777) (183,551) Total $ 5,243,256 $ 4,299,799 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Property and Equipment, net | |
Schedule of property and equipment | September 30, December 31, 2022 2021 (unaudited) Computer software and hardware $ 1,062,468 $ 837,826 Furniture and fixtures 1,503,426 1,252,434 Leasehold improvements 257,786 237,086 Machinery and equipment 2,110,769 2,066,003 Tooling in-process 639,053 537,043 5,573,502 4,930,392 Accumulated depreciation (3,280,986) (2,861,016) Total $ 2,292,516 $ 2,069,376 |
Schedule of property and equipment, net, information by geographic region | September 30, December 31, 2022 2021 (unaudited) United States $ 2,142,195 $ 1,855,012 International 150,321 214,364 Total property and equipment, net $ 2,292,516 $ 2,069,376 |
Intangible Assets, net (Tables)
Intangible Assets, net (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Intangible Assets, net | |
Summary of the components of intangible asset balances | September 30, December 31, 2022 2021 (unaudited) Patents — in use $ 392,037 $ 372,502 Patents — in process 96,575 111,593 Internally developed software — in use 872,218 872,218 Internally developed software — in process 1,302,362 468,441 Trademarks 27,697 27,697 2,690,889 1,852,451 Accumulated amortization (809,752) (733,867) Total $ 1,881,137 $ 1,118,584 |
Schedule of expected annual amortization expense related to intangible assets (excludes in process intangible assets) | Three months ending December 31, 2022 $ 25,236 2023 $ 100,946 2024 $ 100,544 2025 $ 97,374 2026 $ 85,658 2027 $ 11,945 |
Investments (Tables)
Investments (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Investments | |
Summary of available-for-sale securities | September 30, 2022 Gross Gross Unrealized Unrealized Fair Cost Gains Losses Value U.S. corporate bonds $ — $ — $ — $ — December 31, 2021 Gross Gross Unrealized Unrealized Fair Cost Gains Losses Value U.S. corporate bonds $ 491,975 $ 9,880 $ — $ 501,855 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Fair Value Measurements | |
Schedule of the fair value of assets and liabilities subject to recurring fair value measurements | Fair Value at September 30, 2022 Quoted Prices Significant in Active Other Significant Market for Observable Unobservable Fair Identical Assets Inputs Inputs Value (Level 1) (Level 2) (Level 3) U.S. treasury bills $ 39,690,640 $ — $ 39,690,640 $ — Fair Value at December 31, 2021 Quoted Prices Significant in Active Other Significant Market for Observable Unobservable Fair Identical Assets Inputs Inputs Value (Level 1) (Level 2) (Level 3) U.S. corporate bonds $ 501,855 $ — $ 501,855 $ — |
Accumulated Other Comprehensi_2
Accumulated Other Comprehensive Income (Loss) (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Accumulated Other Comprehensive Income | |
Schedule of components of accumulated other comprehensive loss, net of tax | The components of accumulated other comprehensive income, net of tax, for the three months ended September 30, 2022 and 2021 are as follows: Unrealized (Losses) Gains on Available-For-Sale Securities Balance at June 30, 2022 $ — Loss on available-for-sale securities, net — Reclassification realized in net earnings — Balance at September 30, 2022 $ — Balance at June 30, 2021 $ 24,179 Gains on available-for-sale securities, net (2,948) Reclassification realized in net earnings — Balance at September 30, 2021 $ 21,231 The components of accumulated other comprehensive income, net of tax, for the nine months ended September 30, 2022 and 2021 are as follows: Unrealized (Losses) Gains on Available-For-Sale Securities Balance at December 31, 2021 $ 17,012 Loss on available-for-sale securities, net (10,953) Reclassification realized in net earnings (6,059) Balance at September 30, 2022 $ — Balance at December 31, 2020 $ 37,087 Loss on available-for-sale securities, net (6,027) Reclassification realized in net earnings (9,829) Balance at September 30, 2021 $ 21,231 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Stock-Based Compensation | |
Schedule of stock-based compensation | Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 (unaudited) (unaudited) Cost of revenue $ 50,007 $ 68,227 $ 137,386 $ 177,375 General and administrative 186,293 152,261 393,668 513,319 Sales and marketing 116,255 96,210 315,929 269,505 Research and development 40,633 45,138 120,568 107,390 Total $ 393,188 $ 361,836 $ 967,551 $ 1,067,589 |
Schedule of stock-based compensation activity | The following table presents a summary of our stock-based compensation activity for the nine months ended September 30, 2022 (shares): Performance Based Stock Restricted Restricted Options Stock Units Stock Units Outstanding beginning of period 39,576 131,182 18,301 Awards granted — 26,836 — Awards exercised/vested (15,566) (8,099) — Awards canceled/ forfeited — (27,691) (9,236) Outstanding end of period 24,010 122,228 9,065 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Leases | |
Schedule of operating lease cost | Three Months Ended Nine Months Ended September 30, September 30, 2022 2021 2022 2021 (unaudited) (unaudited) Cost of revenue $ 58,086 $ 53,854 $ 165,794 $ 156,043 General and administrative 57,474 54,710 164,046 158,672 Sales and marketing 3,251 3,014 9,279 8,733 Research and development 9,006 8,350 25,706 24,195 Total $ 127,817 $ 119,928 $ 364,825 $ 347,643 |
Schedule of maturity of operating lease liability | Three months ending December 31, 2022 $ 103,823 2023 415,294 2024 415,294 2025 415,294 2026 411,008 Thereafter 989,857 Total lease payments 2,750,570 Imputed interest (474,366) Present value of lease liability $ 2,276,204 |
Basis of Presentation (Details)
Basis of Presentation (Details) | 9 Months Ended |
Sep. 30, 2022 segment | |
Basis of Presentation | |
Number of reportable segment | 1 |
Revenue Recognition - Informati
Revenue Recognition - Information by geographic region (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Contract Liabilities | ||||
Total revenue | $ 13,407,272 | $ 10,907,302 | $ 38,439,551 | $ 29,941,721 |
United States | ||||
Contract Liabilities | ||||
Total revenue | 10,810,370 | 8,676,488 | 31,606,401 | 23,992,474 |
International | ||||
Contract Liabilities | ||||
Total revenue | $ 2,596,902 | $ 2,230,814 | $ 6,833,150 | $ 5,949,247 |
Revenue Recognition - Informa_2
Revenue Recognition - Information by Type (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Disaggregation of Revenue | ||||
Total Devices revenue | $ 9,448,562 | $ 7,148,510 | $ 26,699,887 | $ 19,090,173 |
Disposables, services and other | 3,410,015 | 3,285,656 | 10,158,922 | 9,412,091 |
Amortization of extended warranty agreements | 548,695 | 473,136 | 1,580,742 | 1,439,457 |
Total revenue | 13,407,272 | 10,907,302 | 38,439,551 | 29,941,721 |
MRI Compatible IV Infusion Pump Systems | ||||
Disaggregation of Revenue | ||||
Total Devices revenue | 3,866,535 | 3,369,068 | 11,001,490 | 9,329,182 |
MRI Compatible Patient Vital Signs Monitoring Systems | ||||
Disaggregation of Revenue | ||||
Total Devices revenue | 5,519,045 | $ 3,779,442 | 15,635,415 | $ 9,760,991 |
Ferro Magnetic Detection Systems | ||||
Disaggregation of Revenue | ||||
Total Devices revenue | $ 62,982 | $ 62,982 |
Revenue Recognition - Contract
Revenue Recognition - Contract Liabilities (Details) - USD ($) | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Deferred Revenue | |||
Advance payments from customers | $ 184,653 | $ 551,267 | |
Shipments in-transit | 10,867 | 70,295 | |
Extended warranty agreements | 3,573,230 | 3,610,877 | |
Total | 3,768,750 | $ 4,353,098 | $ 4,232,439 |
Changes in contract liabilities | |||
Contract liabilities, beginning balance | 4,232,439 | 4,254,672 | |
Increases due to cash received from customers | 2,927,868 | 3,617,619 | |
Decreases due to recognition of revenue | (3,391,557) | (3,519,193) | |
Contract liabilities, ending balance | $ 3,768,750 | $ 4,353,098 |
Revenue Recognition - Capitaliz
Revenue Recognition - Capitalized Contract Costs (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Revenue Recognition | ||
Capitalized contract costs | $ 351,150 | $ 357,810 |
Basic and Diluted Net Income _3
Basic and Diluted Net Income per Share (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Basic and Diluted Net Income per Share | ||||||||
Net income | $ 3,427,104 | $ 3,241,052 | $ 2,486,713 | $ 2,576,261 | $ 1,469,694 | $ 1,386,849 | $ 9,154,870 | $ 5,432,804 |
Weighted-average shares outstanding - Basic (in shares) | 12,564,636 | 12,331,062 | 12,559,465 | 12,318,476 | ||||
Effect of dilutive securities: | ||||||||
Stock options | 18,196 | 187,737 | 21,198 | 191,439 | ||||
Restricted stock units | 48,297 | 84,767 | 56,662 | 61,010 | ||||
Weighted-average shares outstanding - Diluted (in shares) | 12,631,129 | 12,603,566 | 12,637,325 | 12,570,925 | ||||
Basic net income per share (in dollars per share) | $ 0.27 | $ 0.21 | $ 0.73 | $ 0.44 | ||||
Diluted net income per share (in dollars per share) | $ 0.27 | $ 0.20 | $ 0.72 | $ 0.43 | ||||
Anti-dilutive stock | ||||||||
Anti-dilutive stock options and restricted stock units | 26,402 | 164 | 31,254 | 2,644 |
Inventory, net (Details)
Inventory, net (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Inventories, net | ||
Raw materials | $ 4,715,981 | $ 3,777,846 |
Work in process | 337,217 | 191,722 |
Finished goods | 402,835 | 513,782 |
Inventory before allowance for excess and obsolete | 5,456,033 | 4,483,350 |
Allowance for excess and obsolete | (212,777) | (183,551) |
Total | $ 5,243,256 | $ 4,299,799 |
Property and Equipment, net (De
Property and Equipment, net (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Property and equipment | |||||
Property and equipment, gross | $ 5,573,502 | $ 5,573,502 | $ 4,930,392 | ||
Accumulated depreciation | (3,280,986) | (3,280,986) | (2,861,016) | ||
Total | 2,292,516 | 2,292,516 | 2,069,376 | ||
Depreciation expense of property and equipment | 142,389 | $ 131,541 | 419,970 | $ 396,278 | |
Computer software and hardware | |||||
Property and equipment | |||||
Property and equipment, gross | 1,062,468 | 1,062,468 | 837,826 | ||
Furniture and fixtures | |||||
Property and equipment | |||||
Property and equipment, gross | 1,503,426 | 1,503,426 | 1,252,434 | ||
Leasehold improvements | |||||
Property and equipment | |||||
Property and equipment, gross | 257,786 | 257,786 | 237,086 | ||
Machinery and equipment | |||||
Property and equipment | |||||
Property and equipment, gross | 2,110,769 | 2,110,769 | 2,066,003 | ||
Tooling in-process | |||||
Property and equipment | |||||
Property and equipment, gross | $ 639,053 | $ 639,053 | $ 537,043 |
Property and Equipment, net - G
Property and Equipment, net - Geographic information (Details) - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
Property and equipment | ||
Total property and equipment, net | $ 2,292,516 | $ 2,069,376 |
United States | ||
Property and equipment | ||
Total property and equipment, net | 2,142,195 | 1,855,012 |
International | ||
Property and equipment | ||
Total property and equipment, net | $ 150,321 | $ 214,364 |
Intangible Assets, net (Details
Intangible Assets, net (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Intangible assets | |||||
Intangible Assets, gross | $ 2,690,889 | $ 2,690,889 | $ 1,852,451 | ||
Accumulated amortization | (809,752) | (809,752) | (733,867) | ||
Total | 1,881,137 | 1,881,137 | 1,118,584 | ||
Amortization expense of intangible assets | 25,236 | $ 25,256 | 75,886 | $ 76,478 | |
Expected annual amortization expense | |||||
Three months ending December 31, 2022 | 25,236 | 25,236 | |||
2023 | 100,946 | 100,946 | |||
2024 | 100,544 | 100,544 | |||
2025 | 97,374 | 97,374 | |||
2026 | 85,658 | 85,658 | |||
2027 | 11,945 | 11,945 | |||
Patents - in use | |||||
Intangible assets | |||||
Intangible Assets, gross | 392,037 | 392,037 | 372,502 | ||
Patents - in process | |||||
Intangible assets | |||||
Intangible Assets, gross | 96,575 | 96,575 | 111,593 | ||
Internally developed software - in use | |||||
Intangible assets | |||||
Intangible Assets, gross | 872,218 | 872,218 | 872,218 | ||
Internally developed software - in process | |||||
Intangible assets | |||||
Intangible Assets, gross | 1,302,362 | 1,302,362 | 468,441 | ||
Trademarks | |||||
Intangible assets | |||||
Intangible Assets, gross | $ 27,697 | $ 27,697 | $ 27,697 |
Investments (Details)
Investments (Details) - U.S. corporate bonds | 12 Months Ended |
Dec. 31, 2021 USD ($) | |
Investments | |
Cost | $ 491,975 |
Gross Unrealized Gains | 9,880 |
Fair Value | $ 501,855 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - Recurring - USD ($) | Sep. 30, 2022 | Dec. 31, 2021 |
U.S. corporate bonds | ||
Fair Value Measurements | ||
Total | $ 501,855 | |
U.S. corporate bonds | Significant Other Observable Inputs (Level 2) | ||
Fair Value Measurements | ||
Total | $ 501,855 | |
U.S. treasury bills | ||
Fair Value Measurements | ||
Total | $ 39,690,640 | |
U.S. treasury bills | Significant Other Observable Inputs (Level 2) | ||
Fair Value Measurements | ||
Total | $ 39,690,640 |
Accumulated Other Comprehensi_3
Accumulated Other Comprehensive Income (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Component of accumulated other comprehensive loss | |||
Balance at the beginning | $ 24,179 | $ 17,012 | $ 37,087 |
Loss on available-for-sale securities, net | (2,948) | (10,953) | (6,027) |
Reclassification realized in net earnings | $ (6,059) | (9,829) | |
Balance at the end | $ 21,231 | $ 21,231 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Stock-Based Compensation | ||||
Total stock-based compensation expense | $ 393,188 | $ 361,836 | $ 967,551 | $ 1,067,589 |
Cost of revenue | ||||
Stock-Based Compensation | ||||
Total stock-based compensation expense | 50,007 | 68,227 | 137,386 | 177,375 |
General and administrative | ||||
Stock-Based Compensation | ||||
Total stock-based compensation expense | 186,293 | 152,261 | 393,668 | 513,319 |
Sales and marketing | ||||
Stock-Based Compensation | ||||
Total stock-based compensation expense | 116,255 | 96,210 | 315,929 | 269,505 |
Research and development | ||||
Stock-Based Compensation | ||||
Total stock-based compensation expense | $ 40,633 | $ 45,138 | $ 120,568 | $ 107,390 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Options and Restricted Stock Units Activity (Details) - USD ($) | 9 Months Ended |
Sep. 30, 2022 | |
Stock Options | |
Stock Options | |
Outstanding beginning of period (in shares) | 39,576 |
Awards exercised/vested (in shares) | (15,566) |
Outstanding end of period (in shares) | 24,010 |
Restricted Stock Units | |
Stock Options | |
Outstanding beginning of period (in shares) | 131,182 |
Awards granted (in shares) | 26,836 |
Awards exercised/vested (in shares) | (8,099) |
Awards canceled/ forfeited (in shares) | (27,691) |
Outstanding end of period (in shares) | 122,228 |
Weighted-average period of unrecognized compensation cost expected to be recognized | 2 years 7 months 24 days |
Unrecognized compensation cost for unvested award | $ 2,749,903 |
Performance Based Restricted Stock Units | |
Stock Options | |
Outstanding beginning of period (in shares) | 18,301 |
Awards canceled/ forfeited (in shares) | (9,236) |
Outstanding end of period (in shares) | 9,065 |
Weighted-average period of unrecognized compensation cost expected to be recognized | 1 year 11 months 26 days |
Unrecognized compensation cost for unvested award | $ 251,841 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Income Taxes | ||||
Provision for income tax expense (benefit) | $ 810,375 | $ 517,767 | $ 2,322,301 | $ 1,289,988 |
Effective tax rate (as a percent) | 19.10% | 16.70% | 20.20% | 19.20% |
Leases (Details)
Leases (Details) | 1 Months Ended | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
Jan. 31, 2014 USD ($) | Sep. 30, 2022 USD ($) item | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) item | Sep. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | |
Leases | ||||||
Number of material lease contract outstanding | item | 1 | 1 | ||||
Lease cost paid | $ 127,817 | $ 119,928 | $ 364,825 | $ 347,643 | ||
Lessee, operating lease, existence of option to extend | true | |||||
Lessee, operating lease, existence of residual value guarantee | false | |||||
Susi, LLC | ||||||
Leases | ||||||
Lease cost paid | $ 364,825 | $ 347,643 | $ 461,874 | |||
Susi, LLC | Winter Springs, Florida Facility | ||||||
Leases | ||||||
Monthly base rent | $ 34,133 | |||||
Renewal term of lease beginning in 2019 | 5 years | |||||
Number of successive renewal terms of lease | 1 | |||||
Renewal term of lease beginning in 2024 | 5 years | |||||
Renewal term lease thereafter | 1 year | |||||
Remaining lease term (in years) | 6 years 7 months 6 days | 6 years 7 months 6 days |
Leases - Operating Lease Cost (
Leases - Operating Lease Cost (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Leases | ||||
Operating lease cost | $ 127,817 | $ 119,928 | $ 364,825 | $ 347,643 |
Cost of revenue | ||||
Leases | ||||
Operating lease cost | 58,086 | 53,854 | 165,794 | 156,043 |
General and administrative | ||||
Leases | ||||
Operating lease cost | 57,474 | 54,710 | 164,046 | 158,672 |
Sales and marketing | ||||
Leases | ||||
Operating lease cost | 3,251 | 3,014 | 9,279 | 8,733 |
Research and development | ||||
Leases | ||||
Operating lease cost | $ 9,006 | $ 8,350 | $ 25,706 | $ 24,195 |
Leases - Maturity of Lease Liab
Leases - Maturity of Lease Liabilities (Details) | Sep. 30, 2022 USD ($) |
Operating leases | |
Six months ending December 31, 2022 | $ 103,823 |
2023 | 415,294 |
2024 | 415,294 |
2025 | 415,294 |
2026 | 411,008 |
Thereafter | 989,857 |
Total lease payments | 2,750,570 |
Imputed interest | (474,366) |
Present value of lease liability | $ 2,276,204 |
Commitments and Contingencies (
Commitments and Contingencies (Details) | 9 Months Ended | 12 Months Ended | |
Nov. 01, 2022 USD ($) a | Sep. 30, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Purchase commitments | |||
Purchase commitments | $ 7,903,021 | $ 5,604,456 | |
Accruals related to legal matters | $ 136,927 | $ 146,000 | |
Closing of Inspection period | 30 days | ||
Sale and purchase agreement | O Property LTD | |||
Purchase commitments | |||
Purchase of land | a | 27 | ||
Total purchase price of the property | $ 7,300,000 |