Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2017 | Apr. 30, 2017 | |
Document and Entity Information | ||
Entity Registrant Name | IRADIMED CORP | |
Entity Central Index Key | 1,325,618 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2017 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 10,749,895 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q1 |
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS - USD ($) | Mar. 31, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 17,456,641 | $ 17,713,871 |
Accounts receivable, net of allowance for doubtful accounts of $35,775 as of March 31, 2017 and $44,308 as of December 31, 2016 | 3,737,117 | 3,775,699 |
Investments | 7,788,741 | 7,965,521 |
Inventory, net | 4,273,721 | 3,886,590 |
Prepaid expenses and other current assets | 359,691 | 362,900 |
Prepaid income taxes | 134,624 | 151,820 |
Total current assets | 33,750,535 | 33,856,401 |
Property and equipment, net | 1,633,080 | 1,456,149 |
Intangible assets, net | 898,223 | 918,712 |
Deferred income taxes | 964,129 | 789,402 |
Other assets | 171,346 | 173,820 |
Total assets | 37,417,313 | 37,194,484 |
Current liabilities: | ||
Accounts payable | 859,114 | 1,120,830 |
Accrued payroll and benefits | 1,004,771 | 1,035,266 |
Other accrued taxes | 119,595 | 119,094 |
Warranty reserve | 64,074 | 40,905 |
Deferred revenue | 1,075,608 | 1,033,146 |
Other current liability | 120,634 | 120,634 |
Accrued income taxes | 375,953 | 192,006 |
Total current liabilities | 3,619,749 | 3,661,881 |
Deferred revenue | 1,771,042 | 1,643,478 |
Total liabilities | 5,390,791 | 5,305,359 |
Stockholders' equity: | ||
Common stock; $0.0001 par value; 31,500,000 shares authorized; 10,749,895 shares issued and outstanding as of March 31, 2017 and 10,722,675 shares issued and outstanding as of December 31, 2016 | 1,075 | 1,072 |
Additional paid-in capital | 12,434,675 | 12,055,188 |
Retained earnings | 19,622,441 | 19,869,714 |
Accumulated other comprehensive loss | (31,669) | (36,849) |
Total stockholders' equity | 32,026,522 | 31,889,125 |
Total liabilities and stockholders' equity | $ 37,417,313 | $ 37,194,484 |
CONDENSED BALANCE SHEETS (Paren
CONDENSED BALANCE SHEETS (Parenthetical) - USD ($) | Mar. 31, 2017 | Dec. 31, 2016 |
CONDENSED BALANCE SHEETS | ||
Accounts receivable, allowance for doubtful accounts | $ 35,775 | $ 44,308 |
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 | 10,749,895 | 10,722,675 |
Common stock, shares outstanding | 10,749,895 | 10,722,675 |
CONDENSED STATEMENTS OF OPERATI
CONDENSED STATEMENTS OF OPERATIONS - USD ($) | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
CONDENSED STATEMENTS OF OPERATIONS | ||
Revenue | $ 5,162,560 | $ 8,964,153 |
Cost of revenue | 1,387,618 | 1,705,797 |
Gross profit | 3,774,942 | 7,258,356 |
Operating expenses: | ||
General and administrative | 2,107,257 | 2,259,722 |
Sales and marketing | 1,364,776 | 1,283,048 |
Research and development | 541,290 | 234,336 |
Total operating expenses | 4,013,323 | 3,777,106 |
(Loss) income from operations | (238,381) | 3,481,250 |
Other income, net | 29,524 | 31,778 |
(Loss) income before provision for income taxes | (208,857) | 3,513,028 |
Provision for income tax expense | 24,483 | 1,231,017 |
Net (loss) income | $ (233,340) | $ 2,282,011 |
Net (loss) income per share: | ||
Basic (in dollars per share) | $ (0.02) | $ 0.21 |
Diluted (in dollars per share) | $ (0.02) | $ 0.19 |
Weighted average shares outstanding: | ||
Basic (in shares) | 10,740,979 | 11,095,950 |
Diluted (in shares) | 10,740,979 | 12,326,108 |
CONDENSED STATEMENTS OF COMPREH
CONDENSED STATEMENTS OF COMPREHENSIVE INCOME - USD ($) | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
CONDENSED STATEMENTS OF COMPREHENSIVE INCOME | ||
Net (loss) income | $ (233,340) | $ 2,282,011 |
Other comprehensive income: | ||
Change in fair value of available-for-sale securities, net of income tax expense of $110 and $6,058, respectively | 2,124 | 9,838 |
Realized loss on available-for-sale securities reclassified to net income, net of income tax benefit of $2,043 and $2,620, respectively | 3,056 | 4,256 |
Other comprehensive income | 5,180 | 14,094 |
Comprehensive (loss) income | $ (228,160) | $ 2,296,105 |
CONDENSED STATEMENTS OF COMPRE6
CONDENSED STATEMENTS OF COMPREHENSIVE INCOME (Parenthetical) - USD ($) | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
CONDENSED STATEMENTS OF COMPREHENSIVE INCOME | ||
Change in fair value of available-for-sale securities, tax expense | $ 110 | $ 6,058 |
Reclassification to net income, tax benefit | $ 2,043 | $ 2,620 |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS - USD ($) | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Operating activities: | ||
Net (loss) income | $ (233,340) | $ 2,282,011 |
Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities: | ||
Bad debt expense | (8,533) | 15,686 |
Provision for excess and obsolete inventory | (7,171) | 74,946 |
Depreciation and amortization | 84,069 | 60,914 |
Excess tax benefit on the exercise of stock options | (56,579) | |
Stock-based compensation | 376,424 | 391,183 |
Loss on maturities of investments | 5,099 | 7,026 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 47,115 | (796,987) |
Inventory | (321,552) | (478,033) |
Prepaid expenses and other current assets | 2,018 | (23,346) |
Other assets | 3,665 | (4,384) |
Deferred income taxes | (176,659) | (179,790) |
Accounts payable | (320,124) | 219,531 |
Accrued payroll and benefits | (30,495) | (413,037) |
Other accrued taxes | 501 | (8,924) |
Warranty reserve | 23,169 | 457 |
Deferred revenue | 170,026 | 94,673 |
Accrued income taxes, net of prepaid income taxes | 201,143 | 1,246,506 |
Net cash (used in) provided by operating activities | (184,645) | 2,431,853 |
Investing activities: | ||
Purchases of investments | (1,321,257) | (728,336) |
Proceeds from maturity of investments | 1,500,050 | 300,000 |
Purchases of property and equipment | (240,400) | (199,338) |
Capitalized intangible assets | (111) | (289,591) |
Net cash used in investing activities | (61,718) | (917,265) |
Financing activities: | ||
Proceeds from stock option exercises | 33,086 | 73,590 |
Taxes paid related to the net share settlement of equity awards | (43,953) | |
Income tax benefits credited to equity | 56,579 | |
Purchases of treasury stock | (5,505,439) | |
Net cash used in financing activities | (10,867) | (5,375,270) |
Net decrease in cash and cash equivalents | (257,230) | (3,860,682) |
Cash and cash equivalents, beginning of period | 17,713,871 | 19,368,114 |
Cash and cash equivalents, end of period | $ 17,456,641 | 15,507,432 |
Supplemental disclosure of cash flow information: | ||
Cash paid for income taxes | $ 164,300 |
Basis of Presentation
Basis of Presentation | 3 Months Ended |
Mar. 31, 2017 | |
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 (“SEC”). Certain information and footnote disclosures normally presented in annual financial statements prepared in accordance with U.S. generally accepted accounting principles 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 months ended March 31, 2017 are not necessarily indicative of the results that may be expected for the year ending December 31, 2017. These accompanying interim condensed financial statements should be read 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, 2016. The accounting policies followed in the preparation of these interim condensed financial statements are consistent in all material respects with those described in Note 1 of our 10-K. Certain prior year amounts have been reclassified to conform to current year presentation. FDA Warning Letter The FDA conducted a routine inspection of our prior facility between April 7 and April 16, 2014. This was the first FDA inspection of our facility since the voluntary product recall in August 2012 of certain infusion sets and the voluntary recall in July 2013 of our DERS software. The FDA issued a Form 483 on April 16, 2014 that identified eight observations. The majority of the observations related to procedural and documentation issues associated with the design, development, validation testing and documentation of software used in certain of our products. Other observations were related to the design validation of pump labeling, design analysis of tube stretching, procedures for post-market design review, and control and procedures related to handling certain reported complaints. We submitted a response to the Form 483 in May 2014 and June 2014 in which we described our proposed corrective and preventative actions to address each of the FDA’s observations. On September 2, 2014, we received a warning letter from the FDA relating to this inspection (the “Warning Letter”). The Warning Letter stated that the FDA accepted as adequate several of our responses to Form 483 observations, identified two responses whose accuracy will be determined in the next scheduled inspection of our facility and identified issues for which our response was determined to be inadequate. The issues identified as inadequate concern our procedures for validating device design primarily related to software quality assurance. Also, the Warning Letter raised a new issue. The Warning Letter stated that modifications made to software on our previously cleared infusion pumps, the MRidium 3860 and MRidium 3850, were “significant” and required submission of new premarket notifications under Section 510(k) (a “510(k) submission”) of the FDC Act. These modifications were made over time. We believe they were insignificant and did not require premarket notification submissions. However, the FDA indicated that the modifications of the software for the MRidium 3860 and the software for the MRidium 3850 were “significant” modifications because they could significantly affect the safety or effectiveness of these devices. As a result, the Warning Letter states that the products being sold by us are “adulterated” and “misbranded” under the FDC Act. The Warning Letter also indicates that the MRidium 3860+ infusion pump requires separate FDA clearance from the MRidium 3860 and MRidium 3850. The Warning Letter requested that we immediately cease activities that result in the misbranding or adulteration of the MRidium 3860 MRI infusion pump, MRidium 3850 MRI infusion pump, and the MRidium 3860+ MRI infusion pump, including the commercial distribution of the devices. We immediately complied with the Warning Letter and ceased sale and distribution of the identified products in the United States. On September 4, 2014, we submitted to the FDA our initial response to the Warning Letter and on September 17, 2014 we sent an additional response that included supplemental information related to the Form 483 inspection observations for which the FDA considered our initial responses inadequate. On November 25, 2014, we announced that we filed the 510(k) submission related to our MRidium 3860+ MRI IV infusion pumps and on December 12, 2014 we were notified that our 510(k) submission had been formally accepted for review by the FDA. On December 22, 2014, under FDA enforcement discretion, we announced that we resumed domestic distribution of our MRI compatible MRidium 3860+ MRI IV infusion pump systems, without the DERS option. On January 28, 2015, under FDA enforcement discretion, we announced that we resumed domestic distribution of our DERS option. On December 9, 2015, we met with the FDA to review responses to the agency’s additional information letter. On December 15, 2016, we received FDA 510(k) clearance for our MRidium 3860+ MRI IV infusion pump system, including the DERS software feature. We continue to pursue closure of the Warning Letter, however, as of March 31, 2017, the Warning Letter remains open. Certain Significant Risks and Uncertainties We market our products to end users in the United States and to 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. Recent Accounting Pronouncements Accounting Pronouncements Implemented in 2017 In July 2015, the FASB issued ASU 2015-11, Simplifying the Measurement of Inventory (Topic 330). The amendments in this update require that inventory within the scope of this ASU be measured at the lower of cost and net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predicable costs of completion, disposal and transportation. The amendments in this ASU do not apply to inventory that is measured using last-in, first-out (LIFO) or the retail inventory method. The amendments apply to all other inventory, which includes inventory that is measured at first-in, first-out (FIFO) or average cost. The update is effective for annual periods beginning after December 15, 2016, including interim periods within that reporting period. We adopted this guidance effective January 1, 2017 on a prospective basis. The adoption of this guidance did not impact our financial condition, results of operations or cash flows. In November 2015, the FASB issued ASU 2015-17, Balance Sheet Classification of Deferred Taxes (Topic 740). The amendments in this update require that deferred tax liabilities and assets be classified as noncurrent in a classified statement of financial position. The amendments in the update apply to all entities that present a classified statement of financial position. The current requirement that deferred tax liabilities and assets of a tax-paying component of an entity be offset and presented as a single amount is not affected by the amendments in this update. The update is effective for annual periods beginning after December 15, 2016, including interim periods within that reporting period. We adopted this guidance effective January 1, 2017 on a retrospective basis. As a result of the adoption, $311,871 of deferred tax assets were reclassified from current to noncurrent assets, as of December 31, 2016. In March 2016, the FASB issued ASU 2016-09, Compensation — Stock Compensation (Topic 718). This update identifies areas for simplification involving several aspects of accounting for share-based payment transactions, including the recognition of excess tax benefits and deficiencies, the classification of excess tax benefits on the statement of cash flows, classification of awards as either equity or liabilities and an option to recognize gross stock compensation expense with actual forfeitures recognized as they occur. This update is effective for annual and interim periods beginning after December 15, 2016. We adopted this guidance effective January 1, 2017. Beginning January 1, 2017, excess tax benefits and deficiencies are reflected in the Statement of Operations as a component of the provision for income tax expense, whereas they were previously recognized as additional paid-in capital on the Balance Sheet. Adoption of this guidance resulted in the recognition of $74,625 of net tax deficiencies in our provision for income tax expense, with the effect of increasing our income tax expense for the three months ended March 31, 2017. Additionally, beginning with the three months ended March 31, 2017, and on a prospective basis, the guidance now requires excess tax benefits and deficiencies be presented in the Statement of Cash Flows as an operating activity rather than as a financing activity, while the payment of withholding taxes on the net share settlement of equity awards be presented as a financing activity. The implementation of this guidance did not have a material impact on the Statement of Cash Flows for the three months ended March 31, 2017. Prior period amounts were not retrospectively adjusted. Effective January 1, 2017, we elected to recognize forfeitures as they occur rather than continue to estimate forfeitures expected to occur. This change in accounting policy resulted in an immaterial cumulative-effect adjustment to retained earnings for the three months ended March 31, 2017. The remaining updates required by this standard did not have a material impact to our interim unaudited condensed financial statements. Recently Issued Accounting Pronouncements to be Implemented In May 2014, the FASB issued Accounting Standards Update (“ASU”) 2014-09, Revenue Contracts with Customers (Topic 606). This update provides guidance on the recognition of revenue based upon the entity’s contracts with customers to transfer goods or services at an amount that reflects the consideration the entity expects to receive in exchange for those goods or services. This update also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts. This update is effective for annual periods beginning after December 15, 2017, including interim periods within that reporting period, which will require us to adopt this update in the first quarter of 2018. Early adoption is now permitted. We are evaluating this guidance and have not yet determined the effect it will have on our financial statements and related disclosures, if any. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). This update requires lessees to recognize, on the balance sheet, assets and liabilities for the rights and obligations created by all leases not considered short-term leases. For short-term leases, lessees may elect an accounting policy by class of underlying assets under which right-of-use assets and lease liabilities are not recognized and lease payments are generally recognized as expense over the lease term on a straight-line basis. The accounting by lessors will remain largely unchanged from current U.S. GAAP. This update is effective for annual periods beginning after December 15, 2018, including interim periods within that reporting period, which will require us to adopt this update in the first quarter of 2019. Early adoption is permitted. We are in the process of determining the method and date of adoption and assessing the impact of the update on our financial condition and results of operations. |
Basic and Diluted Net (Loss) In
Basic and Diluted Net (Loss) Income per Share | 3 Months Ended |
Mar. 31, 2017 | |
Basic and Diluted Net (Loss) Income per Share | |
Basic and Diluted Net (Loss) Income per Share | 2 — Basic and Diluted Net (Loss) Income per Share Basic net (loss) 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. The underwriters’ warrants, stock options and 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 March 31, 2017 2016 (unaudited) Net (loss) income $ ) $ Weighted-average shares outstanding — Basic Effect of dilutive securities: Underwriters’ warrants — Stock options — Restricted stock units — Weighted-average shares outstanding — Diluted Basic net (loss) income per share $ ) $ Diluted net (loss) income per share $ ) $ Warrants and 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: As of March 31, 2017 2016 (unaudited) Anti-dilutive warrants, stock options and restricted stock units |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2017 | |
Inventory | |
Inventory | 3 — Inventory Inventory consists of: March 31, December 31, (unaudited) Raw materials $ $ Work in process Finished goods Inventory before allowance for excess and obsolete Allowance for excess and obsolete ) ) Total $ $ |
Property and Equipment
Property and Equipment | 3 Months Ended |
Mar. 31, 2017 | |
Property and Equipment | |
Property and Equipment | 4 — Property and Equipment Property and equipment consist of: March 31, December 31, (unaudited) Computer software and hardware $ $ Furniture and fixtures Leasehold improvements Machinery and equipment Tooling in-process Accumulated depreciation ) ) Total $ $ Depreciation and amortization expense of property and equipment was $63,469 and $53,566 for the three months ended March 31, 2017 and 2016, respectively. |
Intangible Assets
Intangible Assets | 3 Months Ended |
Mar. 31, 2017 | |
Intangible Assets | |
Intangible Assets | 5 — Intangible Assets The following table summarizes the components of intangible asset balances: March 31, December 31, (unaudited) Patents — in use $ $ Patents — in process Internally developed software — in use Internally developed software — in process — Trademarks Accumulated amortization ) ) Total $ $ Amortization expense of intangible assets was $20,600 and $7,348 for the three months ended March 31, 2017 and 2016, respectively. Expected annual amortization expense for the remaining portion of 2017 and the next five years related to intangible assets is as follows: Nine months ending December 31, 2017 $ 2018 2019 2020 2021 2022 |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2017 | |
Stock-Based Compensation | |
Stock-Based Compensation | 6 — Stock-Based Compensation Stock-based compensation was recognized as follows in the Condensed Statements of Operations: Three Months Ended 2017 2016 (unaudited) Cost of revenue $ $ General and administrative Sales and marketing Research and development Total $ $ As of March 31, 2017 we had $1,288,422 of unrecognized compensation cost related to unvested stock options, which is expected to be recognized over a weighted-average period of 1.6 years. As of March 31, 2017, we had $2,011,755 of unrecognized compensation cost related to unvested Restricted Stock Units (RSUs), which is expected to be recognized over a weighted-average period of 2.8 years. The following table presents a summary of our stock-based compensation activity for the three months ended March 31, 2017: Stock Restricted Outstanding beginning of period Awards granted — Awards exercised/vested ) (17, 396 ) Awards canceled ) ) Outstanding end of period |
Investments
Investments | 3 Months Ended |
Mar. 31, 2017 | |
Investments | |
Investments | 7 — Investments Our investments consisted of corporate bonds that we have classified as available-for-sale and are summarized in the following tables: March 31, 2017 Cost Gross Gross Fair Corporate bonds: U.S. corporations $ $ $ $ International corporations Total $ $ $ $ December 31, 2016 Cost Gross Gross Fair Corporate bonds: U.S. corporations $ $ $ $ International corporations Total $ $ $ $ Unrealized losses from the above investments for all periods presented are attributable to changes in interest rates. We do not believe any of these unrealized losses represent other-than-temporary impairments based on our evaluation of available evidence as of March 31, 2017. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2017 | |
Fair Value Measurements | |
Fair Value Measurements | 8 — Fair Value Measurements The fair value of our assets and liabilities subject to recurring fair value measurements are as follows: Fair Value at March 31, 2017 Fair Quoted Prices Significant Significant Corporate bonds: U.S. corporations $ $ — $ $ — International corporations — — Total $ $ — $ $ — Fair Value at December 31, 2016 Fair Quoted Prices Significant Significant Corporate bonds: U.S. corporations $ $ — $ $ — International corporations — — Total $ $ — $ $ — Our corporate bonds are valued by a third-party custodian at closing prices from national exchanges or pricing vendors on the valuation date. There were no transfers into or out of any Levels during the three months ended March 31, 2017 or the year ended December 31, 2016. |
Accumulated Other Comprehensive
Accumulated Other Comprehensive Loss | 3 Months Ended |
Mar. 31, 2017 | |
Accumulated Other Comprehensive Loss | |
Accumulated Other Comprehensive Loss | 9 — Accumulated Other Comprehensive Loss The components of accumulated other comprehensive loss, net of tax, for the three months ended March 31, 2017 and 2016 are as follows: Unrealized (Losses) Balances at December 31, 2016 $ ) Gains, net Reclassification realized in net earnings Balances at March 31, 2017 $ ) Balances at December 31, 2015 $ ) Gains, net Reclassification realized in net earnings Balances at March 31, 2016 $ ) |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2017 | |
Income Taxes | |
Income Taxes | 10 — Income Taxes We recorded provisions for income tax expense of $24,483 and $1,231,017 for the three months ended March 31, 2017 and 2016, respectively. Our effective tax rate was (11.7)% and 35.0% for the three months ended March 31, 2017 and 2016, respectively. A reconciliation of the statutory U.S. federal tax rate to our effective rate is as follows: Three Months Ended March 31, 2017 2016 Statutory U.S. federal tax rate % % State taxes, net of federal benefit Stock-based compensation expense Domestic production activities deduction ) ) Research and development credits ) ) Permanent items — Tax deficiencies, net of tax benefits related to stock-based compensation ) — Total )% % As of March 31, 2017 and December 31, 2016, we have 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 file tax returns in the United States Federal jurisdiction and many state jurisdictions. Our returns are not currently under examination by the Internal Revenue Service or other taxing authorities. The Company is subject to income tax examinations for our United States Federal and State income taxes for 2013 and subsequent years. |
Segment, Customer and Geographi
Segment, Customer and Geographic Information | 3 Months Ended |
Mar. 31, 2017 | |
Segment, Customer and Geographic Information | |
Segment, Customer and Geographic Information | 11 — Segment, Customer and Geographic Information We operate in one reportable segment which is the development, manufacture and sale of MRI compatible medical devices, related accessories and services for use by hospitals and acute care facilities during MRI procedures. In the U.S., we sell our products through our direct sales force and outside of the U.S. we sell our products through distributors who resell our products to end users. Revenue information by geographic region is as follows: Three Months Ended 2017 2016 (unaudited) United States $ $ International Total revenue $ $ Revenue information by type is as follows: Three Months Ended 2017 2016 (unaudited) Devices: MRI Compatible IV Infusion Pump Systems $ $ MRI Compatible Patient Vital Signs Monitoring Systems — Total Devices Revenue Disposable IV Sets and Services Total revenue $ $ Property and equipment, net, information by geographic region is as follows: March 31, December 31, (unaudited) United States $ $ International Total property and equipment, net $ $ Long-lived assets held outside of the United States consist principally of tooling, which is a component of property and equipment, net. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2017 | |
Commitments and Contingencies | |
Commitments and Contingencies | 12 — Commitments and Contingencies Leases. In January 2014, we entered into a non-cancelable operating lease, commencing July 1, 2014, for a new manufacturing and headquarters facility in Winter Springs, Florida owned by Susi, LLC, an entity controlled by our President and CEO, Roger Susi. Pursuant to the terms of our lease for this property, the monthly base rent is $32,649, adjusted annually for changes in the consumer price index. Under the terms of the lease, we are responsible for property taxes, insurance and maintenance expenses. The term of the lease expires on May 31, 2019. Unless advance written notice of termination is timely provided, the lease will automatically renew for two successive terms of five years each beginning in 2019 and again in 2024, and thereafter, will be renewed for successive terms of one year each. A summary of our non-cancelable operating lease commitments of March 31, 2017 is as follows: Nine months ending December 31, 2017 $ 2018 2019 2020 — 2021 — Total non-cancelable operating lease commitments $ Rent expense under our operating leases was $101,505 and $101,258 for the three months ended March 31, 2017 and 2016, respectively. Leasehold improvements are amortized over the shorter of the initial lease term or the estimated useful life. Purchase commitments. We had various purchase orders for goods or services totaling approximately $2,246,282 at March 31, 2017 and $3,683,481 at December 31, 2016. No amounts related to these purchase orders have been recognized in our balance sheet. Legal matters. We may from time to time become party to various legal proceedings or claims that arise in the ordinary course of business. |
Common Stock
Common Stock | 3 Months Ended |
Mar. 31, 2017 | |
Common Stock | |
Common Stock | 13 — Common Stock The table below summarizes our common stock activity (shares): Balance, December 31, 2016 Option exercises Vesting of restricted stock units, net of shares withheld for taxes Balance, March 31, 2017 |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2017 | |
Subsequent Events | |
Subsequent Events | 14 — Subsequent Events On April 27, 2017, our Board of Directors approved a stock repurchase program, authorizing the repurchase of up to $8.0 million of our common stock through April 28, 2018. We intend to use our cash, investments and cash generated from operations to fund the share repurchases. The timing and amount of the repurchases will be subject to applicable legal requirements including federal and state securities laws. Purchases will be made in open market transactions effected through a broker-dealer at prevailing market prices, in block trades, or in privately negotiated transactions. Any repurchased shares will be available for general corporate purchases. |
Basis of Presentation (Policies
Basis of Presentation (Policies) | 3 Months Ended |
Mar. 31, 2017 | |
Basis of Presentation | |
FDA Warning Letter | FDA Warning Letter The FDA conducted a routine inspection of our prior facility between April 7 and April 16, 2014. This was the first FDA inspection of our facility since the voluntary product recall in August 2012 of certain infusion sets and the voluntary recall in July 2013 of our DERS software. The FDA issued a Form 483 on April 16, 2014 that identified eight observations. The majority of the observations related to procedural and documentation issues associated with the design, development, validation testing and documentation of software used in certain of our products. Other observations were related to the design validation of pump labeling, design analysis of tube stretching, procedures for post-market design review, and control and procedures related to handling certain reported complaints. We submitted a response to the Form 483 in May 2014 and June 2014 in which we described our proposed corrective and preventative actions to address each of the FDA’s observations. On September 2, 2014, we received a warning letter from the FDA relating to this inspection (the “Warning Letter”). The Warning Letter stated that the FDA accepted as adequate several of our responses to Form 483 observations, identified two responses whose accuracy will be determined in the next scheduled inspection of our facility and identified issues for which our response was determined to be inadequate. The issues identified as inadequate concern our procedures for validating device design primarily related to software quality assurance. Also, the Warning Letter raised a new issue. The Warning Letter stated that modifications made to software on our previously cleared infusion pumps, the MRidium 3860 and MRidium 3850, were “significant” and required submission of new premarket notifications under Section 510(k) (a “510(k) submission”) of the FDC Act. These modifications were made over time. We believe they were insignificant and did not require premarket notification submissions. However, the FDA indicated that the modifications of the software for the MRidium 3860 and the software for the MRidium 3850 were “significant” modifications because they could significantly affect the safety or effectiveness of these devices. As a result, the Warning Letter states that the products being sold by us are “adulterated” and “misbranded” under the FDC Act. The Warning Letter also indicates that the MRidium 3860+ infusion pump requires separate FDA clearance from the MRidium 3860 and MRidium 3850. The Warning Letter requested that we immediately cease activities that result in the misbranding or adulteration of the MRidium 3860 MRI infusion pump, MRidium 3850 MRI infusion pump, and the MRidium 3860+ MRI infusion pump, including the commercial distribution of the devices. We immediately complied with the Warning Letter and ceased sale and distribution of the identified products in the United States. On September 4, 2014, we submitted to the FDA our initial response to the Warning Letter and on September 17, 2014 we sent an additional response that included supplemental information related to the Form 483 inspection observations for which the FDA considered our initial responses inadequate. On November 25, 2014, we announced that we filed the 510(k) submission related to our MRidium 3860+ MRI IV infusion pumps and on December 12, 2014 we were notified that our 510(k) submission had been formally accepted for review by the FDA. On December 22, 2014, under FDA enforcement discretion, we announced that we resumed domestic distribution of our MRI compatible MRidium 3860+ MRI IV infusion pump systems, without the DERS option. On January 28, 2015, under FDA enforcement discretion, we announced that we resumed domestic distribution of our DERS option. On December 9, 2015, we met with the FDA to review responses to the agency’s additional information letter. On December 15, 2016, we received FDA 510(k) clearance for our MRidium 3860+ MRI IV infusion pump system, including the DERS software feature. We continue to pursue closure of the Warning Letter, however, as of March 31, 2017, the Warning Letter remains open. |
Certain Significant Risks and Uncertainties | Certain Significant Risks and Uncertainties We market our products to end users in the United States and to 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. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements Accounting Pronouncements Implemented in 2017 In July 2015, the FASB issued ASU 2015-11, Simplifying the Measurement of Inventory (Topic 330). The amendments in this update require that inventory within the scope of this ASU be measured at the lower of cost and net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predicable costs of completion, disposal and transportation. The amendments in this ASU do not apply to inventory that is measured using last-in, first-out (LIFO) or the retail inventory method. The amendments apply to all other inventory, which includes inventory that is measured at first-in, first-out (FIFO) or average cost. The update is effective for annual periods beginning after December 15, 2016, including interim periods within that reporting period. We adopted this guidance effective January 1, 2017 on a prospective basis. The adoption of this guidance did not impact our financial condition, results of operations or cash flows. In November 2015, the FASB issued ASU 2015-17, Balance Sheet Classification of Deferred Taxes (Topic 740). The amendments in this update require that deferred tax liabilities and assets be classified as noncurrent in a classified statement of financial position. The amendments in the update apply to all entities that present a classified statement of financial position. The current requirement that deferred tax liabilities and assets of a tax-paying component of an entity be offset and presented as a single amount is not affected by the amendments in this update. The update is effective for annual periods beginning after December 15, 2016, including interim periods within that reporting period. We adopted this guidance effective January 1, 2017 on a retrospective basis. As a result of the adoption, $311,871 of deferred tax assets were reclassified from current to noncurrent assets, as of December 31, 2016. In March 2016, the FASB issued ASU 2016-09, Compensation — Stock Compensation (Topic 718). This update identifies areas for simplification involving several aspects of accounting for share-based payment transactions, including the recognition of excess tax benefits and deficiencies, the classification of excess tax benefits on the statement of cash flows, classification of awards as either equity or liabilities and an option to recognize gross stock compensation expense with actual forfeitures recognized as they occur. This update is effective for annual and interim periods beginning after December 15, 2016. We adopted this guidance effective January 1, 2017. Beginning January 1, 2017, excess tax benefits and deficiencies are reflected in the Statement of Operations as a component of the provision for income tax expense, whereas they were previously recognized as additional paid-in capital on the Balance Sheet. Adoption of this guidance resulted in the recognition of $74,625 of net tax deficiencies in our provision for income tax expense, with the effect of increasing our income tax expense for the three months ended March 31, 2017. Additionally, beginning with the three months ended March 31, 2017, and on a prospective basis, the guidance now requires excess tax benefits and deficiencies be presented in the Statement of Cash Flows as an operating activity rather than as a financing activity, while the payment of withholding taxes on the net share settlement of equity awards be presented as a financing activity. The implementation of this guidance did not have a material impact on the Statement of Cash Flows for the three months ended March 31, 2017. Prior period amounts were not retrospectively adjusted. Effective January 1, 2017, we elected to recognize forfeitures as they occur rather than continue to estimate forfeitures expected to occur. This change in accounting policy resulted in an immaterial cumulative-effect adjustment to retained earnings for the three months ended March 31, 2017. The remaining updates required by this standard did not have a material impact to our interim unaudited condensed financial statements. Recently Issued Accounting Pronouncements to be Implemented In May 2014, the FASB issued Accounting Standards Update (“ASU”) 2014-09, Revenue Contracts with Customers (Topic 606). This update provides guidance on the recognition of revenue based upon the entity’s contracts with customers to transfer goods or services at an amount that reflects the consideration the entity expects to receive in exchange for those goods or services. This update also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts. This update is effective for annual periods beginning after December 15, 2017, including interim periods within that reporting period, which will require us to adopt this update in the first quarter of 2018. Early adoption is now permitted. We are evaluating this guidance and have not yet determined the effect it will have on our financial statements and related disclosures, if any. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). This update requires lessees to recognize, on the balance sheet, assets and liabilities for the rights and obligations created by all leases not considered short-term leases. For short-term leases, lessees may elect an accounting policy by class of underlying assets under which right-of-use assets and lease liabilities are not recognized and lease payments are generally recognized as expense over the lease term on a straight-line basis. The accounting by lessors will remain largely unchanged from current U.S. GAAP. This update is effective for annual periods beginning after December 15, 2018, including interim periods within that reporting period, which will require us to adopt this update in the first quarter of 2019. Early adoption is permitted. We are in the process of determining the method and date of adoption and assessing the impact of the update on our financial condition and results of operations. |
Basic and Diluted Net (Loss) 23
Basic and Diluted Net (Loss) Income per Share (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Basic and Diluted Net (Loss) Income per Share | |
Schedule of computation of basic and diluted net income per share | Three Months Ended March 31, 2017 2016 (unaudited) Net (loss) income $ ) $ Weighted-average shares outstanding — Basic Effect of dilutive securities: Underwriters’ warrants — Stock options — Restricted stock units — Weighted-average shares outstanding — Diluted Basic net (loss) income per share $ ) $ Diluted net (loss) income per share $ ) $ |
Schedule of warrants and stock options to purchase shares of common stock and restricted stock units excluded from the calculation of diluted net income per share | As of March 31, 2017 2016 (unaudited) Anti-dilutive warrants, stock options and restricted stock units |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Inventory | |
Schedule of inventory | March 31, December 31, (unaudited) Raw materials $ $ Work in process Finished goods Inventory before allowance for excess and obsolete Allowance for excess and obsolete ) ) Total $ $ |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Property and Equipment | |
Schedule of property and equipment | March 31, December 31, (unaudited) Computer software and hardware $ $ Furniture and fixtures Leasehold improvements Machinery and equipment Tooling in-process Accumulated depreciation ) ) Total $ $ |
Intangible Assets (Tables)
Intangible Assets (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Intangible Assets | |
Summary of the components of intangible asset balances | March 31, December 31, (unaudited) Patents — in use $ $ Patents — in process Internally developed software — in use Internally developed software — in process — Trademarks Accumulated amortization ) ) Total $ $ |
Schedule of expected annual amortization expense related to intangible assets | Nine months ending December 31, 2017 $ 2018 2019 2020 2021 2022 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Stock-Based Compensation | |
Schedule of stock-based compensation | Three Months Ended 2017 2016 (unaudited) Cost of revenue $ $ General and administrative Sales and marketing Research and development Total $ $ |
Summary of stock options and restricted stock units activity | The following table presents a summary of our stock-based compensation activity for the three months ended March 31, 2017: Stock Restricted Outstanding beginning of period Awards granted — Awards exercised/vested ) (17, 396 ) Awards canceled ) ) Outstanding end of period |
Investments (Tables)
Investments (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Investments | |
Summary of available for sale securities | March 31, 2017 Cost Gross Gross Fair Corporate bonds: U.S. corporations $ $ $ $ International corporations Total $ $ $ $ December 31, 2016 Cost Gross Gross Fair Corporate bonds: U.S. corporations $ $ $ $ International corporations Total $ $ $ $ |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Fair Value Measurements | |
Schedule of the fair value of assets and liabilities subject to recurring fair value measurements | Fair Value at March 31, 2017 Fair Quoted Prices Significant Significant Corporate bonds: U.S. corporations $ $ — $ $ — International corporations — — Total $ $ — $ $ — Fair Value at December 31, 2016 Fair Quoted Prices Significant Significant Corporate bonds: U.S. corporations $ $ — $ $ — International corporations — — Total $ $ — $ $ — |
Accumulated Other Comprehensi30
Accumulated Other Comprehensive Loss (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Accumulated Other Comprehensive Loss | |
Schedule of components of accumulated other comprehensive loss, net of tax | Unrealized (Losses) Balances at December 31, 2016 $ ) Gains, net Reclassification realized in net earnings Balances at March 31, 2017 $ ) Balances at December 31, 2015 $ ) Gains, net Reclassification realized in net earnings Balances at March 31, 2016 $ ) |
Income Taxes (Tables)
Income Taxes (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Income Taxes | |
Schedule of reconciliation of statutory U.S. federal tax rate to effective rate | Three Months Ended March 31, 2017 2016 Statutory U.S. federal tax rate % % State taxes, net of federal benefit Stock-based compensation expense Domestic production activities deduction ) ) Research and development credits ) ) Permanent items — Tax deficiencies, net of tax benefits related to stock-based compensation ) — Total )% % |
Segment, Customer and Geograp32
Segment, Customer and Geographic Information (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Segment, Customer and Geographic Information | |
Schedule of revenue information by geographic region | Three Months Ended 2017 2016 (unaudited) United States $ $ International Total revenue $ $ |
Schedule of revenue information by external customers by product | Three Months Ended 2017 2016 (unaudited) Devices: MRI Compatible IV Infusion Pump Systems $ $ MRI Compatible Patient Vital Signs Monitoring Systems — Total Devices Revenue Disposable IV Sets and Services Total revenue $ $ |
Schedule of property and equipment, net information by geographic region | March 31, December 31, (unaudited) United States $ $ International Total property and equipment, net $ $ |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Commitments and Contingencies | |
Schedule of future minimum lease payments under noncancelable operating leases | A summary of our non-cancelable operating lease commitments of March 31, 2017 is as follows: Nine months ending December 31, 2017 $ 2018 2019 2020 — 2021 — Total non-cancelable operating lease commitments $ |
Common Stock (Tables)
Common Stock (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Common Stock | |
Summary of common stock activity | The table below summarizes our common stock activity (shares): Balance, December 31, 2016 Option exercises Vesting of restricted stock units, net of shares withheld for taxes Balance, March 31, 2017 |
Basis of Presentation (Details)
Basis of Presentation (Details) - item | Sep. 02, 2014 | Apr. 16, 2014 |
FDA Matters | ||
Number of observations | 8 | |
Number of identified responses whose accuracy will be determined | 2 |
Basis of Presentation - Recent
Basis of Presentation - Recent Accounting Pronouncements (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2017 | Mar. 31, 2016 | Dec. 31, 2016 | |
Deferred income taxes, noncurrent | $ 964,129 | $ 789,402 | |
Provision for income tax expense | 24,483 | $ 1,231,017 | |
ASU 2015-17 | |||
Deferred income taxes, current | (311,871) | ||
Deferred income taxes, noncurrent | $ 311,871 | ||
ASU 2016-09 | |||
Provision for income tax expense | $ 74,625 |
Basic and Diluted Net (Loss) 37
Basic and Diluted Net (Loss) Income per Share (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Basic and Diluted Net (Loss) Income per Share | ||
Net (loss) income | $ (233,340) | $ 2,282,011 |
Weighted-average shares outstanding - Basic (in shares) | 10,740,979 | 11,095,950 |
Effect of dilutive securities: | ||
Underwriters' warrants | 107,333 | |
Stock options | 1,122,821 | |
Restricted stock units | 4 | |
Weighted-average shares outstanding - Diluted (in shares) | 10,740,979 | 12,326,108 |
Basic net (loss) income per share (in dollars per share) | $ (0.02) | $ 0.21 |
Diluted net (loss) income per share (in dollars per share) | $ (0.02) | $ 0.19 |
Anti-dilutive stock | ||
Anti-dilutive warrants, stock options and restricted stock units (in shares) | 1,423,854 | 86,467 |
Inventory (Details)
Inventory (Details) - USD ($) | Mar. 31, 2017 | Dec. 31, 2016 |
Inventory | ||
Raw materials | $ 3,779,341 | $ 3,241,642 |
Work in process | 183,812 | 135,626 |
Finished goods | 510,741 | 716,666 |
Inventory before allowance for excess and obsolete | 4,473,894 | 4,093,934 |
Allowance for excess and obsolete | (200,173) | (207,344) |
Total | $ 4,273,721 | $ 3,886,590 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2017 | Mar. 31, 2016 | Dec. 31, 2016 | |
Property and equipment | |||
Property and equipment, gross | $ 2,895,533 | $ 2,655,133 | |
Accumulated depreciation | (1,262,453) | (1,198,984) | |
Total | 1,633,080 | 1,456,149 | |
Depreciation and amortization expense of property and equipment | 63,469 | $ 53,566 | |
Computer software and hardware | |||
Property and equipment | |||
Property and equipment, gross | 464,786 | 462,352 | |
Furniture and fixtures | |||
Property and equipment | |||
Property and equipment, gross | 374,495 | 358,587 | |
Leasehold improvements | |||
Property and equipment | |||
Property and equipment, gross | 191,139 | 191,139 | |
Machinery and equipment | |||
Property and equipment | |||
Property and equipment, gross | 1,084,058 | 1,064,957 | |
Tooling in-process | |||
Property and equipment | |||
Property and equipment, gross | $ 781,055 | $ 578,098 |
Intangible Assets (Details)
Intangible Assets (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2017 | Mar. 31, 2016 | Dec. 31, 2016 | |
Intangible assets | |||
Intangible Assets, gross | $ 1,126,151 | $ 1,126,040 | |
Accumulated amortization | (227,928) | (207,328) | |
Total | 898,223 | 918,712 | |
Amortization expense of intangible assets | 20,600 | $ 7,348 | |
Expected annual amortization expense | |||
Nine months ending December 31, 2017 | 61,798 | ||
2,018 | 82,398 | ||
2,019 | 82,398 | ||
2,020 | 82,398 | ||
2,021 | 82,398 | ||
2,022 | 82,398 | ||
Patents - in use | |||
Intangible assets | |||
Intangible Assets, gross | 168,383 | 168,383 | |
Patents - in process | |||
Intangible assets | |||
Intangible Assets, gross | 67,182 | 67,071 | |
Internally developed software - in use | |||
Intangible assets | |||
Intangible Assets, gross | 867,569 | 148,967 | |
Internally developed software - in process | |||
Intangible assets | |||
Intangible Assets, gross | 718,602 | ||
Trademarks | |||
Intangible assets | |||
Intangible Assets, gross | $ 23,017 | $ 23,017 |
Stock-Based Compensation (Detai
Stock-Based Compensation (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Stock-Based Compensation | ||
Total stock-based compensation expense | $ 376,424 | $ 391,183 |
Cost of revenue | ||
Stock-Based Compensation | ||
Total stock-based compensation expense | 50,561 | 35,069 |
General and administrative | ||
Stock-Based Compensation | ||
Total stock-based compensation expense | 195,845 | 202,247 |
Sales and marketing | ||
Stock-Based Compensation | ||
Total stock-based compensation expense | 111,961 | 140,265 |
Research and development | ||
Stock-Based Compensation | ||
Total stock-based compensation expense | 18,057 | $ 13,602 |
Stock Options | ||
Stock-Based Compensation | ||
Total unrecognized compensation expense | $ 1,288,422 | |
Weighted average period expected to be recognized | 1 year 7 months 6 days | |
Restricted Stock Units | ||
Stock-Based Compensation | ||
Total unrecognized compensation expense | $ 2,011,755 | |
Weighted average period expected to be recognized | 2 years 9 months 18 days |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock options and restricted stock units activity (Details) | 3 Months Ended |
Mar. 31, 2017shares | |
Stock Options | |
Options | |
Outstanding beginning of period (in shares) | 1,482,204 |
Options exercised/vested (in shares) | (13,437) |
Options cancelled (in shares) | (3,500) |
Outstanding end of period (in shares) | 1,465,267 |
Restricted Stock Units | |
Restricted Stock Units | |
Unvested at beginning of year (in shares) | 159,646 |
Granted (in shares) | 1,324 |
Exercised/Vested (in shares) | (17,396) |
Cancelled (in shares) | (1,906) |
Unvested at end of year (in shares) | 141,668 |
Investments (Details)
Investments (Details) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2017 | Dec. 31, 2016 | |
Investments | ||
Cost | $ 7,841,660 | $ 8,025,940 |
Gross Unrealized Gains | 2,390 | 2,626 |
Gross Unrealized Losses | 55,309 | 63,045 |
Fair Value | 7,788,741 | 7,965,521 |
U.S. corporations | ||
Investments | ||
Cost | 6,630,015 | 6,814,295 |
Gross Unrealized Gains | 742 | 385 |
Gross Unrealized Losses | 43,091 | 52,072 |
Fair Value | 6,587,666 | 6,762,608 |
International corporations | ||
Investments | ||
Cost | 1,211,645 | 1,211,645 |
Gross Unrealized Gains | 1,648 | 2,241 |
Gross Unrealized Losses | 12,218 | 10,973 |
Fair Value | $ 1,201,075 | $ 1,202,913 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) | Mar. 31, 2017 | Dec. 31, 2016 |
Fair Value Measurements | ||
Fair value assets, amount transferred between measurement levels | $ 0 | $ 0 |
Fair value liabilities, amount transferred between measurement levels | 0 | 0 |
Recurring | ||
Fair Value Measurements | ||
Total | 7,788,741 | 7,965,521 |
Recurring | U.S. corporations | ||
Fair Value Measurements | ||
Total | 6,587,666 | 6,762,608 |
Recurring | International corporations | ||
Fair Value Measurements | ||
Total | 1,201,075 | 1,202,913 |
Recurring | Significant Other Observable Inputs (Level 2) | ||
Fair Value Measurements | ||
Total | 7,788,741 | 7,965,521 |
Recurring | Significant Other Observable Inputs (Level 2) | U.S. corporations | ||
Fair Value Measurements | ||
Total | 6,587,666 | 6,762,608 |
Recurring | Significant Other Observable Inputs (Level 2) | International corporations | ||
Fair Value Measurements | ||
Total | $ 1,201,075 | $ 1,202,913 |
Accumulated Other Comprehensi45
Accumulated Other Comprehensive Loss (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Component of accumulated other comprehensive loss | ||
Balance at the beginning | $ (36,849) | $ (55,285) |
Gains, net | 2,124 | 9,838 |
Reclassification realized in net earnings | 3,056 | 4,256 |
Balance at the end | $ (31,669) | $ (41,191) |
Income Taxes - (Details)
Income Taxes - (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Reconciliation of the statutory U.S. federal tax rate to effective rate | ||
Provisions for income taxes | $ 24,483 | $ 1,231,017 |
Statutory U.S. federal tax rate | 34.00% | 34.00% |
State taxes, net of federal benefit | 5.80% | 4.00% |
Stock compensation expense | 8.40% | 1.00% |
Domestic production activities deduction | (15.20%) | (2.70%) |
Research and development credits | (14.70%) | (1.30%) |
Permanent items | 5.70% | |
Tax deficiencies, net of tax benefits related to stock-based compensation | (35.70%) | |
Total | (11.70%) | 35.00% |
Segment, Customer and Geograp47
Segment, Customer and Geographic Information (Details) | 3 Months Ended | ||
Mar. 31, 2017USD ($)segment | Mar. 31, 2016USD ($)segment | Dec. 31, 2016USD ($) | |
Segment, Customer and Geographic Information | |||
Number of reportable segment | segment | 1 | 1 | |
Revenue | $ 5,162,560 | $ 8,964,153 | |
Property and equipment, net | 1,633,080 | $ 1,456,149 | |
Devices | |||
Segment, Customer and Geographic Information | |||
Revenue | 3,392,313 | 7,295,442 | |
MRI Compatible IV Infusion Pump Systems | |||
Segment, Customer and Geographic Information | |||
Revenue | 3,002,611 | 7,295,442 | |
MRI Compatible Patient Vital Signs Monitoring Systems | |||
Segment, Customer and Geographic Information | |||
Revenue | 389,702 | ||
Disposable IV Sets and Services | |||
Segment, Customer and Geographic Information | |||
Revenue | 1,770,247 | 1,668,711 | |
United States | |||
Segment, Customer and Geographic Information | |||
Revenue | 4,316,894 | 7,874,516 | |
Property and equipment, net | 1,167,454 | 1,112,382 | |
International | |||
Segment, Customer and Geographic Information | |||
Revenue | 845,666 | $ 1,089,637 | |
Property and equipment, net | $ 465,626 | $ 343,767 |
Commitments and Contingencies48
Commitments and Contingencies (Details) | 1 Months Ended | 3 Months Ended | ||
Jan. 30, 2014USD ($)item | Mar. 31, 2017USD ($) | Mar. 31, 2016USD ($) | Dec. 31, 2016USD ($) | |
Purchase commitments | ||||
Purchase commitments | $ 2,246,282 | $ 3,683,481 | ||
Susi, LLC | Winter Springs, Florida Facility | ||||
Leases | ||||
Monthly base rent | $ 32,649 | |||
Number of successive renewal terms of lease | item | 2 | |||
Renewal term of lease beginning in 2019 | 5 years | |||
Renewal term of lease beginning in 2024 | 5 years | |||
Renewal term lease thereafter | 1 year | |||
Rent expense | 101,505 | $ 101,258 | ||
Future minimum lease payments under noncancelable operating leases | ||||
Nine months ending December 31, 2017 | 294,961 | |||
2,018 | 393,417 | |||
2,019 | 163,242 | |||
Total minimum lease payments | $ 851,620 |
Common Stock - Common stock act
Common Stock - Common stock activity (Details) | 3 Months Ended |
Mar. 31, 2017shares | |
Common stock activity | |
Balances at the beginning | 10,722,675 |
Balances at the end | 10,749,895 |
Common Stock | |
Common stock activity | |
Balances at the beginning | 10,722,675 |
Option exercises | 13,437 |
Vesting of restricted stock units, net of shares withheld of taxes | 13,783 |
Balances at the end | 10,749,895 |
Subsequent Events (Details)
Subsequent Events (Details) $ in Millions | Apr. 27, 2017USD ($) |
Subsequent Event | Common Stock | |
Subsequent Events | |
Repurchase of the stock | $ 8 |