Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Sep. 30, 2014 | Oct. 31, 2014 | |
Document and Entity Information | ' | ' |
Entity Registrant Name | 'IRADIMED CORP | ' |
Entity Central Index Key | '0001325618 | ' |
Document Type | '10-Q | ' |
Document Period End Date | 30-Sep-14 | ' |
Amendment Flag | 'false | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Current Reporting Status | 'Yes | ' |
Entity Filer Category | 'Smaller Reporting Company | ' |
Entity Common Stock, Shares Outstanding | ' | 10,814,650 |
Document Fiscal Year Focus | '2014 | ' |
Document Fiscal Period Focus | 'Q3 | ' |
CONDENSED_BALANCE_SHEETS
CONDENSED BALANCE SHEETS (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Current assets: | ' | ' |
Cash and cash equivalents | $18,113,859 | $2,461,559 |
Accounts receivable, net of allowance for doubtful accounts of $37,368 as of September 30, 2014 and $136,971 as of December 31, 2013 | 1,174,103 | 1,982,083 |
Investments | ' | 246,203 |
Inventory, net | 1,639,977 | 1,340,331 |
Prepaid expenses and other current assets | 247,937 | 119,974 |
Prepaid income taxes | ' | 170,496 |
Deferred income taxes | 67,916 | 65,961 |
Total current assets | 21,243,792 | 6,386,607 |
Property and equipment, net | 755,267 | 327,343 |
Intangible assets, net | 259,473 | 267,024 |
Deferred income taxes | 131,130 | ' |
Other assets | 21,866 | 5,897 |
Total assets | 22,411,528 | 6,986,871 |
Current liabilities: | ' | ' |
Accounts payable | 640,235 | 427,474 |
Accrued payroll and benefits | 919,044 | 655,362 |
Other accrued taxes | 40,384 | 80,787 |
Warranty reserve | 15,671 | 12,002 |
Deferred revenue | 343,051 | 207,395 |
Officer note payable | ' | 6,333 |
Accrued income taxes | 141,818 | 62,971 |
Total current liabilities | 2,100,203 | 1,452,324 |
Deferred revenue | 160,387 | 57,676 |
Deferred income taxes | ' | 54,087 |
Total liabilities | 2,260,590 | 1,564,087 |
Stockholders' equity: | ' | ' |
Preferred stock, $0.0001 par value; 10,000,000 shares authorized; none issued and outstanding as of September 30, 2014 and 1,400,000 shares issued and outstanding as of December 31, 2013 | ' | 140 |
Common stock; $0.0001 par value; 90,000,000 shares authorized; 10,718,400 shares issued and outstanding as of September 30, 2014 and 7,000,000 shares issued and outstanding as of December 31, 2013 | 1,072 | 700 |
Additional paid-in capital | 15,295,438 | 2,346,137 |
Retained earnings | 4,854,428 | 3,074,883 |
Accumulated other comprehensive income | ' | 924 |
Total stockholders' equity | 20,150,938 | 5,422,784 |
Total liabilities and stockholders' equity | $22,411,528 | $6,986,871 |
CONDENSED_BALANCE_SHEETS_Paren
CONDENSED BALANCE SHEETS (Parenthetical) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
CONDENSED BALANCE SHEETS | ' | ' |
Accounts receivable, allowance for doubtful accounts | $37,368 | $136,971 |
Preferred stock, par value (in dollars per share) | $0.00 | $0.00 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 1,400,000 |
Preferred stock, shares outstanding | 0 | 1,400,000 |
Common stock, par value (in dollars per share) | $0.00 | $0.00 |
Common stock, shares authorized | 90,000,000 | 90,000,000 |
Common stock, shares issued | 10,718,400 | 7,000,000 |
Common stock, shares outstanding | 10,718,400 | 7,000,000 |
CONDENSED_STATEMENTS_OF_OPERAT
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME | ' | ' | ' | ' |
Revenue | $3,811,947 | $2,479,749 | $12,069,553 | $7,883,071 |
Cost of revenue | 959,593 | 669,765 | 2,485,704 | 1,904,597 |
Gross profit | 2,852,354 | 1,809,984 | 9,583,849 | 5,978,474 |
Operating expenses: | ' | ' | ' | ' |
General and administrative | 1,261,872 | 640,987 | 3,485,051 | 1,671,726 |
Sales and marketing | 880,711 | 513,734 | 2,505,019 | 1,578,119 |
Research and development | 303,463 | 299,422 | 753,267 | 664,257 |
Total operating expenses | 2,446,046 | 1,454,143 | 6,743,337 | 3,914,102 |
Income from operations | 406,308 | 355,841 | 2,840,512 | 2,064,372 |
Other income, net | -8,808 | 18,817 | 6,275 | 38,216 |
Income before provision for income taxes | 397,500 | 374,658 | 2,846,787 | 2,102,588 |
Provision for income taxes | 160,143 | 113,983 | 1,067,242 | 639,678 |
Net income | 237,357 | 260,675 | 1,779,545 | 1,462,910 |
Other comprehensive income (loss): | ' | ' | ' | ' |
Change in fair value of available-for-sale securities, net of tax expense (benefit) of $70 and $(432) for the three months ended September 30, 2014 and 2013, respectively, and $2,063 and $(2,681) for the nine months ended September 30, 2014 and 2013, respectively | 130 | -803 | 3,832 | -4,979 |
Realized gain on available-for-sale securities reclassified to net income, net of tax of $70 and $2,560 for the three and nine months ended September 30, 2014, respectively | -130 | ' | -4,756 | ' |
Comprehensive income | $237,357 | $259,872 | $1,778,621 | $1,457,931 |
Net income per share: | ' | ' | ' | ' |
Basic (in dollars per share) | $0.02 | $0.04 | $0.22 | $0.21 |
Diluted (in dollars per share) | $0.02 | $0.03 | $0.18 | $0.17 |
Weighted average shares outstanding: | ' | ' | ' | ' |
Basic (in shares) | 10,112,139 | 7,000,000 | 8,048,779 | 7,000,000 |
Diluted (in shares) | 11,269,358 | 8,665,599 | 9,688,602 | 8,562,704 |
CONDENSED_STATEMENTS_OF_OPERAT1
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (Parenthetical) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME | ' | ' | ' | ' |
Change in fair value of available for sale securities, tax expense (benefit) | $70 | ($432) | $2,063 | ($2,681) |
Realized gain on available-for-sale securities reclassified to net income, tax | $70 | ' | $2,560 | ' |
CONDENSED_STATEMENTS_OF_STOCKH
CONDENSED STATEMENTS OF STOCKHOLDERS' EQUITY (USD $) | Preferred Stock | Common Stock | Additional Paid-in Capital | Retained Earnings | Accumulated Other Comprehensive Income | Total |
Balances at Dec. 31, 2013 | $140 | $700 | $2,346,137 | $3,074,883 | $924 | $5,422,784 |
Increase (Decrease) in Stockholders' Equity | ' | ' | ' | ' | ' | ' |
Net income | ' | ' | ' | 1,779,545 | ' | 1,779,545 |
Other comprehensive loss | ' | ' | ' | ' | -924 | -924 |
Stock based compensation | ' | ' | 503,881 | ' | ' | 503,881 |
Issuance of common stock pursuant to initial public offering | ' | 232 | 14,489,768 | ' | ' | 14,490,000 |
Common stock issuance costs and underwriter fees | ' | ' | -2,044,348 | ' | ' | -2,044,348 |
Conversion of preferred stock | -140 | 140 | ' | ' | ' | ' |
Balances at Sep. 30, 2014 | ' | $1,072 | $15,295,438 | $4,854,428 | ' | $20,150,938 |
CONDENSED_STATEMENTS_OF_CASH_F
CONDENSED STATEMENTS OF CASH FLOWS (USD $) | 9 Months Ended | |
Sep. 30, 2014 | Sep. 30, 2013 | |
Operating activities: | ' | ' |
Net income | $1,779,545 | $1,462,910 |
Adjustments to reconcile net income to net cash provided by operating activities: | ' | ' |
Provision for excess and obsolete inventory | 36,709 | ' |
Depreciation and amortization | 99,638 | 97,945 |
Stock-based compensation | 503,881 | 203,939 |
Changes in operating assets and liabilities: | ' | ' |
Accounts receivable | 807,980 | -129,914 |
Inventory | -336,355 | -279,055 |
Prepaid expenses and other current assets | -126,434 | -61,276 |
Other assets | -17,498 | -4,504 |
Deferred income taxes | -189,235 | -44,940 |
Accounts payable | 212,761 | 34,349 |
Accrued payroll and benefits | 263,682 | -92,257 |
Other accrued taxes | -40,403 | 34,881 |
Warranty reserve | 3,669 | -134 |
Deferred revenue | 238,367 | 96,298 |
Accrued income taxes, net of prepaid income taxes | 249,343 | -611,450 |
Other | 1,461 | ' |
Net cash provided by operating activities | 3,487,111 | 706,792 |
Investing activities: | ' | ' |
Purchases of investments | -3,011 | -2,958 |
Proceeds from sale of investments | 255,109 | ' |
Purchases of property and equipment | -504,502 | -121,173 |
Capitalized intangible assets | -21,726 | -22,711 |
Net cash used in investing activities | -274,130 | -146,842 |
Financing activities: | ' | ' |
Repayment of officer note payable | -6,333 | -214,267 |
Proceeds from the issuance of common stock pursuant to initial public offering | 14,490,000 | ' |
Payment of initial public offering costs | -2,044,348 | ' |
Net cash provided by (used in) financing activities | 12,439,319 | -214,267 |
Net increase in cash and equivalents | 15,652,300 | 345,683 |
Cash and cash equivalents, beginning of period | 2,461,559 | 1,697,306 |
Cash and cash equivalents, end of period | 18,113,859 | 2,042,989 |
Supplemental disclosure of cash flow information: | ' | ' |
Cash paid for income taxes | $1,004,574 | $1,301,500 |
Basis_of_Presentation
Basis of Presentation | 9 Months Ended |
Sep. 30, 2014 | |
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 in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The accounting policies followed in the preparation of these interim condensed financial statements are consistent in all material respects with those presented in Note 1 of the Company’s financial statements for the year ended December 31, 2013 included in the Company’s Registration Statement on Form S-1, as amended (File No. 333-196875) (“Registration Statement”), which was declared effective by the Securities and Exchange Commission (“SEC”) on July 15, 2014. | |
Interim financial reports are prepared in accordance with the rules and regulations of the SEC; accordingly, they do not include all of the information and notes required by GAAP for annual financial statements. 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. These accompanying condensed financial statements should be read in conjunction with the Company’s Registration Statement. | |
Our significant accounting policies are disclosed in the Registration Statement and no significant accounting policies were changed. Certain prior year amounts have been reclassified to conform to current year presentation. Operating results for the three and nine months ended September 30, 2014 are not necessarily indicative of the results that may be expected for the year ending December 31, 2014. | |
FDA Warning Letter | |
On September 2, 2014 we announced we received a Warning Letter from the U.S. Food and Drug Administration (“FDA”) relating to an inspection of our facility that took place in April 2014. At the conclusion of the April inspection, FDA issued a Form 483 that identified eight observations. The majority of the observations related to procedures and documentation associated with the design, development and validation testing 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 procedures and processing related to handling certain reported complaints. We submitted responses 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 concerns. | |
FDA’s 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. We intend to respond to this Warning Letter finding. | |
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 Food, Drug and Cosmetic Act (the “FDCA”). 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 FDCA. 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. | |
We are working with the FDA to resolve this issue and resume commercial distribution of our products. 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. See Note 12. | |
Initial Public Offering | |
On July 21, 2014, the Company completed an initial public offering (“IPO”) of its common stock and sold 2,318,400 shares of common stock (including 302,400 shares sold upon the underwriters’ exercise of their over-allotment option to purchase additional shares) at a price of $6.25 per share. The IPO generated net proceeds of approximately $12.4 million, after deducting underwriting discounts and expenses of approximately $2.0 million. These expenses were recorded against the proceeds received from the IPO. Concurrent with the closing of the IPO, all outstanding preferred stock was automatically converted into common stock on a 1:1 basis. | |
Associated with our IPO, we issued the underwriters warrants to purchase up to a total of 201,600 shares of our common stock. The grant date aggregate fair value of the warrants was $611,000. The warrants are exercisable, in whole or in part, commencing July 21, 2015 through July 21, 2017. The warrants are exercisable at a per share price equal to $8.13 per share, or 130% of the public offering price per share of our common stock in the IPO. The exercise price and number of warrant shares may be adjusted upon (1) voluntarily at our discretion, or (2) if we undertake a stock split, stock dividend, recapitalization or reorganization of our common stock into a lesser / greater number of shares, the warrant exercise price will be proportionately reduced / increased and the number of warrant shares will be proportionately increased / decreased. The warrants may only be settled through the issuance of our common stock in exchange for cash. We have classified the warrants as equity and incremental direct costs associated with our IPO. Accordingly, the warrants do not impact our financial statements. | |
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. As of December 31, 2013, one customer accounted for 10.8% of gross accounts receivable. | |
Revenue for the three months ended September 30, 2013 included sales to two international customers that represented 20.9% of total revenue for the three months ended September 30, 2013. | |
Recent Accounting Pronouncements | |
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 contracts with customers. This update is effective for annual periods beginning after December 15, 2016, including interim periods within that reporting period, which will require us to adopt this update in the first quarter of 2017. Early adoption is not 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. | |
Basic_and_Diluted_Net_Income_p
Basic and Diluted Net Income per Share | 9 Months Ended | |||||||||||||
Sep. 30, 2014 | ||||||||||||||
Basic and Diluted Net Income per Share | ' | |||||||||||||
Basic and Diluted Net Income per Share | ' | |||||||||||||
2 — 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. As discussed further in Note 6, the effect of our 1.75:1 stock split and recapitalization is reflected in the number of outstanding shares and per share information in the table below. The underwriters’ warrants, preferred stock and stock options 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, | |||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||
(unaudited) | (unaudited) | |||||||||||||
Net income | $ | 237,357 | $ | 260,675 | $ | 1,779,545 | $ | 1,462,910 | ||||||
Weighted-average shares outstanding — Basic | 10,112,139 | 7,000,000 | 8,048,779 | 7,000,000 | ||||||||||
Effect of dilutive securities: | ||||||||||||||
Underwriters’ warrants | 847 | — | — | — | ||||||||||
Preferred stock | 228,261 | 1,400,000 | 1,005,128 | 1,400,000 | ||||||||||
Stock options | 928,111 | 265,599 | 634,695 | 162,704 | ||||||||||
Weighted-average shares outstanding — Diluted | 11,269,358 | 8,665,599 | 9,688,602 | 8,562,704 | ||||||||||
Basic net income per share | $ | 0.02 | $ | 0.04 | $ | 0.22 | $ | 0.21 | ||||||
Diluted net income per share | $ | 0.02 | $ | 0.03 | $ | 0.18 | $ | 0.17 | ||||||
Warrants and stock options to purchase shares of our common stock 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, | |||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||
(unaudited) | (unaudited) | |||||||||||||
Anti-dilutive stock options | 17,625 | 357,158 | 660,159 | 789,933 | ||||||||||
Inventory
Inventory | 9 Months Ended | |||||||
Sep. 30, 2014 | ||||||||
Inventory | ' | |||||||
Inventory | ' | |||||||
3 — Inventory | ||||||||
Inventory consists of: | ||||||||
September 30, | December 31, | |||||||
2014 | 2013 | |||||||
(unaudited) | ||||||||
Raw materials | $ | 1,427,014 | $ | 1,143,495 | ||||
Work in process | 91,448 | 14,337 | ||||||
Finished goods | 121,515 | 182,499 | ||||||
Total | $ | 1,639,977 | $ | 1,340,331 | ||||
The Company reviews its inventory on a periodic basis for excess, obsolete or impaired inventory and records a reserve for items identified. The Company recorded an allowance for excess and obsolete inventory of $36,709 as of September 30, 2014. | ||||||||
Property_and_Equipment
Property and Equipment | 9 Months Ended | |||||||
Sep. 30, 2014 | ||||||||
Property and Equipment | ' | |||||||
Property and Equipment | ' | |||||||
4 — Property and Equipment | ||||||||
Property and equipment consist of: | ||||||||
September 30, | December 31, | |||||||
2014 | 2013 | |||||||
(unaudited) | ||||||||
Computer software and hardware | $ | 242,086 | $ | 154,709 | ||||
Furniture and fixtures | 184,912 | 87,611 | ||||||
Leasehold improvements | 168,844 | 47,623 | ||||||
Machinery and equipment | 831,107 | 721,270 | ||||||
Tooling in-process | 69,086 | 46,562 | ||||||
1,496,035 | 1,057,775 | |||||||
Accumulated depreciation | (740,768 | ) | (730,432 | ) | ||||
Total | $ | 755,267 | $ | 327,343 | ||||
Depreciation and amortization expense of property and equipment was $35,316 and $23,274 for the three months ended September 30, 2014 and 2013, respectively, and $70,361 and $69,908 for the nine months ended September 30, 2014 and 2013, respectively. | ||||||||
Intangible_Assets
Intangible Assets | 9 Months Ended | |||||||
Sep. 30, 2014 | ||||||||
Intangible Assets | ' | |||||||
Intangible Assets | ' | |||||||
5 — Intangible Assets | ||||||||
The following table summarizes the components of intangible asset balances: | ||||||||
September 30, | December 31, | |||||||
2014 | 2013 | |||||||
(unaudited) | ||||||||
Patents — in use | $ | 238,548 | $ | 228,430 | ||||
Patents — in process | 30,773 | 19,165 | ||||||
Internally developed software | 148,967 | 148,967 | ||||||
418,288 | 396,562 | |||||||
Accumulated amortization | (158,815 | ) | (129,538 | ) | ||||
Total | $ | 259,473 | $ | 267,024 | ||||
Amortization expense of intangible assets was $9,861 and $9,480 for the three months ended September 30, 2014 and 2013, respectively, and $29,277 and $28,037 for the nine months ended September 30, 2014 and 2013, respectively. | ||||||||
Expected annual amortization expense for the next five years related to intangible assets is as follows: | ||||||||
Three months ending December 31, 2014 | $ | 9,861 | ||||||
2015 | 39,446 | |||||||
2016 | 22,143 | |||||||
2017 | 14,665 | |||||||
2018 | 14,665 | |||||||
2019 | 14,665 | |||||||
Capital_Stock
Capital Stock | 9 Months Ended | |||
Sep. 30, 2014 | ||||
Capital Stock | ' | |||
Capital Stock | ' | |||
6 — Capital Stock | ||||
Reincorporation | ||||
Effective April 14, 2014, we reincorporated as a Delaware corporation. As part of this reincorporation, we converted all previously outstanding shares of our Class A Common Stock and Class B Common Stock into a single class of common stock on a 1.75:1 conversion ratio and all previously outstanding shares of our Series A Preferred Stock were split on a 1.75:1 conversion ratio into new Series A Preferred Stock. This recapitalization was accounted for as a stock split as the intent was to provide for wider distribution of our common stock. Our Certificate of Incorporation provides that the Series A Preferred Stock will automatically be converted into shares of common stock immediately upon the earlier of the closing on the first sale of shares of our common stock in an initial firm commitment underwritten public offering pursuant to a registration statement under the Securities Act of 1933, as amended, where the aggregate public offering amount is not less than $10,000,000. In accordance with our Certificate of Incorporation, upon the sale of shares pursuant to this initial public offering, which was completed in July 2014, all of our Series A Preferred Stock was automatically converted into common stock on a 1:1 conversion ratio (see Note 1). The table below summarizes the effect of the stock split and conversion on our capital stock that was previously outstanding as of December 31, 2013: | ||||
Series A Preferred Stock outstanding — Pre recapitalization | 800,000 | |||
Stock split ratio | 1.75:1 | |||
Series A Preferred Stock outstanding — Post recapitalization | 1,400,000 | |||
Common stock outstanding — Pre recapitalization | ||||
Class A Common Stock | 400,000 | |||
Class B Common Stock | 3,600,000 | |||
Total | 4,000,000 | |||
Stock split ratio | 1.75:1 | |||
Common stock outstanding — Post recapitalization | 7,000,000 | |||
As of the effective date of the reincorporation, we are now authorized to issue 90,000,000 shares of Common Stock with a par value of $0.0001 per share and 10,000,000 shares of Preferred Stock with a par value of $0.0001. | ||||
The effect of this stock split has been retroactively applied to per-share computations, share and option amounts for all periods presented within these condensed financial statements and accompanying notes. | ||||
StockBased_Compensation
Stock-Based Compensation | 9 Months Ended | |||||||||||||
Sep. 30, 2014 | ||||||||||||||
Stock Based Compensation | ' | |||||||||||||
Stock Based Compensation | ' | |||||||||||||
7 — Stock-Based Compensation | ||||||||||||||
Stock-based compensation was recognized as follows in the statement of operations: | ||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||
September 30, | September 30, | |||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||
(unaudited) | (unaudited) | |||||||||||||
Cost of revenue | $ | 905 | $ | 3 | $ | 2,834 | $ | 10 | ||||||
General and administrative | 60,235 | 4,115 | 174,737 | 12,345 | ||||||||||
Sales and marketing | 102,606 | 63,775 | 299,594 | 191,322 | ||||||||||
Research and development | 7,853 | 87 | 26,716 | 262 | ||||||||||
Total | $ | 171,599 | $ | 67,980 | $ | 503,881 | $ | 203,939 | ||||||
As of September 30, 2014 we had $2,000,945 of total unrecognized stock-based compensation expense, which is expected to be recognized over a weighted-average period of 3.0 years. | ||||||||||||||
The following table presents a summary of our stock option activity as of and for the nine months ended September 30, 2014: | ||||||||||||||
Options | ||||||||||||||
Outstanding beginning of period | 1,759,692 | |||||||||||||
Options granted | 108,750 | |||||||||||||
Options exercised | — | |||||||||||||
Options canceled | — | |||||||||||||
Outstanding end of period | 1,868,442 | |||||||||||||
Investments
Investments | 9 Months Ended | |||||||||||||
Sep. 30, 2014 | ||||||||||||||
Investments | ' | |||||||||||||
Investments | ' | |||||||||||||
8 — Investments | ||||||||||||||
As of December 31, 2013, our available-for-sale securities consisted of two mutual funds and are summarized in the table below. | ||||||||||||||
Cost | Gross | Gross | Market | |||||||||||
Unrealized | Unrealized | Value | ||||||||||||
Gains | Losses | |||||||||||||
December 31, 2013 | $ | 244,782 | $ | 1,421 | $ | — | $ | 246,203 | ||||||
During the three months ended September 30, 2014, we liquidated our available-for-sale securities at an insignificant gain. | ||||||||||||||
Fair_Value_Measurements
Fair Value Measurements | 9 Months Ended | |||||||||||||
Sep. 30, 2014 | ||||||||||||||
Fair Value Measurements | ' | |||||||||||||
Fair Value Measurements | ' | |||||||||||||
9 — Fair Value Measurements | ||||||||||||||
The fair value of our assets and liabilities subject to recurring fair value measurements are as follows: | ||||||||||||||
Fair Value at December 31, 2013 | ||||||||||||||
Fair | Quoted Prices | Significant | Significant | |||||||||||
Value | in Active | Other | Unobservable | |||||||||||
Market for | Observable | Inputs | ||||||||||||
Identical Assets | Inputs | (Level 3) | ||||||||||||
(Level 1) | (Level 2) | |||||||||||||
Mutual funds | $ | 246,203 | $ | 246,203 | $ | — | $ | — | ||||||
The fair values of our mutual funds are based upon quoted market prices and valuations provided by the third-party custodian of our mutual funds. | ||||||||||||||
There were no transfers into or out of any Levels during the nine months ended September 30, 2014 or for the year ended December 31, 2013. | ||||||||||||||
Income_Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2014 | |
Income Taxes | ' |
Income Taxes | ' |
10 — Income Taxes | |
We recorded provisions for income taxes of $160,143 and $1,067,242 for the three and nine months ended September 30, 2014, respectively. Our effective tax rate was 40.3% and 37.5% for the three and nine months ended September 30, 2014, respectively. Our effective tax rates for the three and nine months ended September 30, 2014 differed from the U.S. Federal statutory rate primarily due to higher U.S. state tax expense, partially offset by the domestic production activities deduction. The U.S. state tax expense increased the effective tax rate by approximately 4.8% and the domestic production activities deduction decreased the effective tax rate by approximately 2.2%. | |
We recorded provision for income taxes of $113,983 and $639,678 for the three and nine months ended September 30, 2013, respectively. Our effective tax rate was 30.4% for both the three and nine months ended September 30, 2013. Our effective tax rate for the three and nine months ended September 30, 2013 differed from the U.S. Federal statutory rate primarily due to the domestic manufacturing deduction and the research and development tax credit enacted by the American Taxpayer Relief Act of 2012. Collectively, the domestic production activities deduction and research and development tax credit decreased the effective tax rate by approximately 6.5%. This benefit was partially offset by higher U.S. state taxes, which increased the effective tax rate by approximately 2.3%. | |
As of September 30, 2014 and December 31, 2013, 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 2008 and subsequent years. | |
Segment_Customer_and_Geographi
Segment, Customer and Geographic Information | 9 Months Ended | |||||||||||||
Sep. 30, 2014 | ||||||||||||||
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 IV infusion pump systems and products 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 | Nine Months Ended | |||||||||||||
September 30, | September 30, | |||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||
(unaudited) | (unaudited) | |||||||||||||
United States | $ | 3,529,024 | $ | 1,654,100 | $ | 10,195,841 | $ | 5,490,016 | ||||||
International | 282,923 | 825,649 | 1,873,712 | 2,393,055 | ||||||||||
$ | 3,811,947 | $ | 2,479,749 | $ | 12,069,553 | $ | 7,883,071 | |||||||
Property and equipment, net, information by geographic region is as follows: | ||||||||||||||
September 30, | December 31, | |||||||||||||
2014 | 2013 | |||||||||||||
(unaudited) | ||||||||||||||
United States | $ | 685,463 | $ | 256,386 | ||||||||||
International | 69,804 | 70,957 | ||||||||||||
$ | 755,267 | $ | 327,343 | |||||||||||
During the three months ended September 30, 2014 and 2013, respectively, revenue from devices was $3,125,189 and $2,012,978, while revenue from disposable IV sets and services were $686,758 and $466,771. During the nine months ended September 30, 2014 and 2013, respectively, revenue from devices was $10,174,816 and $6,386,505, while revenue from disposable IV sets and services were $1,894,737 and $1,496,566. | ||||||||||||||
Revenue for the three months ended September 30, 2013 included sales to two international customers that represented 20.9% of total revenue for the three months ended September 30, 2013. | ||||||||||||||
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 | 9 Months Ended | ||||
Sep. 30, 2014 | |||||
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, CEO and controlling stockholder, Roger Susi. Pursuant to the terms of our lease for this property, the monthly base rent is $32,583, 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 September 30, 2014 is as follows: | |||||
Three months ending December 31, 2014 | $ | 97,749 | |||
2015 | 390,996 | ||||
2016 | 390,996 | ||||
2017 | 390,996 | ||||
2018 | 390,996 | ||||
2019 | 162,915 | ||||
Total non-cancelable operating lease commitments | $ | 1,824,648 | |||
Rent expense under our operating leases was $108,047 and $28,171 for the three months ended September 30, 2014 and 2013, respectively. Rent expense under our operating leases was $170,968 and $85,886 for the nine months ended September 30, 2014 and 2013, respectively. | |||||
Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life. | |||||
Purchase commitments. We had various purchase orders for goods or services totaling approximately $2,038,196 at September 30, 2014 and $1,758,242 at December 31, 2013. No amounts related to these purchase orders have been recognized in our balance sheet. | |||||
Uncommitted revolving credit facility. We had an uncommitted revolving credit facility with Bank of America, National Association that provided for a maximum borrowing capacity of $100,000. This facility was terminated during the three months ended September 30, 2014 and we no longer have the ability to obtain advances from this revolving credit facility. Prior to the termination of this facility during the third quarter 2014 and throughout the year ended December 31, 2013, we did not request or obtain any advances from this revolving credit facility. | |||||
Legal matters. On September 10, 2014, a Civil Action was filed in the U.S. District Count for the Southern District of Florida (“Lam Civil Action”). The Lam Civil Action is a putative class action lawsuit brought against the Company and certain individuals who are officers and / or directors of the Company. The plaintiff is an alleged shareholder of the Company, and seeks relief on behalf of a class of persons who purchased the Company’s common stock during the period from July 15, 2014 through September 2, 2014. The complaint alleges that the defendants failed to disclose material information concerning the Company’s compliance with FDA regulations in violation of Section 10(b) of the Securities Exchange Act of 1934 and Rule 10b-5 thereunder, and that the putative class members suffered damages as a result. The complaint additionally alleges “control person” liability against the individual defendants under Section 20(a) of the Securities Exchange Act of 1934. The Lam Civil Action is presently in the very early stages of litigation. The Company disputes the plaintiff’s allegations and theories of liability, and intends to defend the case vigorously. We have not accrued for any loss related to this matter as we believe that any such loss is not probable or estimable. | |||||
In October 2012, Radimed Gesellschaft für Kommunikationsdienstleistungen und Medizintechnik mbH (“Radimed”) brought an action in Düsseldorf Regional Court against our German distributor alleging the name and sign “IRADIMED” was confusingly similar to their German trademark “Radimed.” A judgment was rendered against our German distributor preventing use of the name and sign “IRADIMED” in Germany. We have however continued to sell products in Germany without any discernible effect by using the name IRI Development. On July 31, 2013, Radimed filed a lawsuit against us and our CEO, Roger Susi, in Düsseldorf Regional Court, alleging that we infringed their German and Community trademarks “Radimed” and seeking to prevent our use of the name, sign and domain name “IRADIMED” in the European Union. In addition, Radimed is seeking unspecified damages. We have not accrued for any loss related to this matter as we believe that any such loss is not probable or estimable. | |||||
In addition to the foregoing, we may from time to time become party to various legal proceedings or claims that arise in the ordinary course of business. | |||||
Related_Party_Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2014 | |
Related Party Transactions | ' |
Related Party Transactions | ' |
13 — Related Party Transactions | |
In the early stages of the Company, our CEO provided funding for operations in the form of an unsecured interest-free note payable with no specified due date. As of December 31, 2013, $6,333 remained outstanding. In March 2014 we repaid with cash the outstanding balance of the note payable. | |
The wife of our CEO provides various foreign language translation, consulting and website management services for the Company. For the three and nine months ended September 30, 2014, we expensed and paid $12,200 and $18,114, respectively, for these services. | |
Basic_and_Diluted_Net_Income_p1
Basic and Diluted Net Income per Share (Tables) | 9 Months Ended | |||||||||||||
Sep. 30, 2014 | ||||||||||||||
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, | |||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||
(unaudited) | (unaudited) | |||||||||||||
Net income | $ | 237,357 | $ | 260,675 | $ | 1,779,545 | $ | 1,462,910 | ||||||
Weighted-average shares outstanding — Basic | 10,112,139 | 7,000,000 | 8,048,779 | 7,000,000 | ||||||||||
Effect of dilutive securities: | ||||||||||||||
Underwriters’ warrants | 847 | — | — | — | ||||||||||
Preferred stock | 228,261 | 1,400,000 | 1,005,128 | 1,400,000 | ||||||||||
Stock options | 928,111 | 265,599 | 634,695 | 162,704 | ||||||||||
Weighted-average shares outstanding — Diluted | 11,269,358 | 8,665,599 | 9,688,602 | 8,562,704 | ||||||||||
Basic net income per share | $ | 0.02 | $ | 0.04 | $ | 0.22 | $ | 0.21 | ||||||
Diluted net income per share | $ | 0.02 | $ | 0.03 | $ | 0.18 | $ | 0.17 | ||||||
Schedule of warrants and stock options to purchase shares of common stock excluded from the calculation of diluted net income per share | ' | |||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||
September 30, | September 30, | |||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||
(unaudited) | (unaudited) | |||||||||||||
Anti-dilutive stock options | 17,625 | 357,158 | 660,159 | 789,933 | ||||||||||
Inventory_Tables
Inventory (Tables) | 9 Months Ended | |||||||
Sep. 30, 2014 | ||||||||
Inventory | ' | |||||||
Schedule of inventory | ' | |||||||
September 30, | December 31, | |||||||
2014 | 2013 | |||||||
(unaudited) | ||||||||
Raw materials | $ | 1,427,014 | $ | 1,143,495 | ||||
Work in process | 91,448 | 14,337 | ||||||
Finished goods | 121,515 | 182,499 | ||||||
Total | $ | 1,639,977 | $ | 1,340,331 | ||||
Property_and_Equipment_Tables
Property and Equipment (Tables) | 9 Months Ended | |||||||
Sep. 30, 2014 | ||||||||
Property and Equipment | ' | |||||||
Schedule of property and equipment | ' | |||||||
September 30, | December 31, | |||||||
2014 | 2013 | |||||||
(unaudited) | ||||||||
Computer software and hardware | $ | 242,086 | $ | 154,709 | ||||
Furniture and fixtures | 184,912 | 87,611 | ||||||
Leasehold improvements | 168,844 | 47,623 | ||||||
Machinery and equipment | 831,107 | 721,270 | ||||||
Tooling in-process | 69,086 | 46,562 | ||||||
1,496,035 | 1,057,775 | |||||||
Accumulated depreciation | (740,768 | ) | (730,432 | ) | ||||
Total | $ | 755,267 | $ | 327,343 | ||||
Intangible_Assets_Tables
Intangible Assets (Tables) | 9 Months Ended | |||||||
Sep. 30, 2014 | ||||||||
Intangible Assets | ' | |||||||
Summary of the components of intangible asset balances | ' | |||||||
September 30, | December 31, | |||||||
2014 | 2013 | |||||||
(unaudited) | ||||||||
Patents — in use | $ | 238,548 | $ | 228,430 | ||||
Patents — in process | 30,773 | 19,165 | ||||||
Internally developed software | 148,967 | 148,967 | ||||||
418,288 | 396,562 | |||||||
Accumulated amortization | (158,815 | ) | (129,538 | ) | ||||
Total | $ | 259,473 | $ | 267,024 | ||||
Schedule of expected annual amortization expense related to intangible assets | ' | |||||||
Three months ending December 31, 2014 | $ | 9,861 | ||||||
2015 | 39,446 | |||||||
2016 | 22,143 | |||||||
2017 | 14,665 | |||||||
2018 | 14,665 | |||||||
2019 | 14,665 | |||||||
Capital_Stock_Tables
Capital Stock (Tables) | 9 Months Ended | |||
Sep. 30, 2014 | ||||
Capital Stock | ' | |||
Summarizes the effect of the stock split and conversion of capital stock previously outstanding | ' | |||
The table below summarizes the effect of the stock split and conversion on our capital stock that was previously outstanding as of December 31, 2013: | ||||
Series A Preferred Stock outstanding — Pre recapitalization | 800,000 | |||
Stock split ratio | 1.75:1 | |||
Series A Preferred Stock outstanding — Post recapitalization | 1,400,000 | |||
Common stock outstanding — Pre recapitalization | ||||
Class A Common Stock | 400,000 | |||
Class B Common Stock | 3,600,000 | |||
Total | 4,000,000 | |||
Stock split ratio | 1.75:1 | |||
Common stock outstanding — Post recapitalization | 7,000,000 | |||
StockBased_Compensation_Tables
Stock-Based Compensation (Tables) | 9 Months Ended | |||||||||||||
Sep. 30, 2014 | ||||||||||||||
Stock Based Compensation | ' | |||||||||||||
Schedule of stock-based compensation | ' | |||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||
September 30, | September 30, | |||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||
(unaudited) | (unaudited) | |||||||||||||
Cost of revenue | $ | 905 | $ | 3 | $ | 2,834 | $ | 10 | ||||||
General and administrative | 60,235 | 4,115 | 174,737 | 12,345 | ||||||||||
Sales and marketing | 102,606 | 63,775 | 299,594 | 191,322 | ||||||||||
Research and development | 7,853 | 87 | 26,716 | 262 | ||||||||||
Total | $ | 171,599 | $ | 67,980 | $ | 503,881 | $ | 203,939 | ||||||
Summary of stock option activity | ' | |||||||||||||
The following table presents a summary of our stock option activity as of and for the nine months ended September 30, 2014: | ||||||||||||||
Options | ||||||||||||||
Outstanding beginning of period | 1,759,692 | |||||||||||||
Options granted | 108,750 | |||||||||||||
Options exercised | — | |||||||||||||
Options canceled | — | |||||||||||||
Outstanding end of period | 1,868,442 | |||||||||||||
Investments_Tables
Investments (Tables) | 9 Months Ended | |||||||||||||
Sep. 30, 2014 | ||||||||||||||
Investments | ' | |||||||||||||
Summary of available for sale securities | ' | |||||||||||||
Cost | Gross | Gross | Market | |||||||||||
Unrealized | Unrealized | Value | ||||||||||||
Gains | Losses | |||||||||||||
December 31, 2013 | $ | 244,782 | $ | 1,421 | $ | — | $ | 246,203 | ||||||
Fair_Value_Measurements_Tables
Fair Value Measurements (Tables) | 9 Months Ended | |||||||||||||
Sep. 30, 2014 | ||||||||||||||
Fair Value Measurements | ' | |||||||||||||
Schedule of the fair value of assets and liabilities subject to recurring fair value measurements | ' | |||||||||||||
Fair Value at December 31, 2013 | ||||||||||||||
Fair | Quoted Prices | Significant | Significant | |||||||||||
Value | in Active | Other | Unobservable | |||||||||||
Market for | Observable | Inputs | ||||||||||||
Identical Assets | Inputs | (Level 3) | ||||||||||||
(Level 1) | (Level 2) | |||||||||||||
Mutual funds | $ | 246,203 | $ | 246,203 | $ | — | $ | — | ||||||
Segment_Customer_and_Geographi1
Segment, Customer and Geographic Information (Tables) | 9 Months Ended | |||||||||||||
Sep. 30, 2014 | ||||||||||||||
Segment, Customer and Geographic Information | ' | |||||||||||||
Schedule of revenue information by geographic region | ' | |||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||
September 30, | September 30, | |||||||||||||
2014 | 2013 | 2014 | 2013 | |||||||||||
(unaudited) | (unaudited) | |||||||||||||
United States | $ | 3,529,024 | $ | 1,654,100 | $ | 10,195,841 | $ | 5,490,016 | ||||||
International | 282,923 | 825,649 | 1,873,712 | 2,393,055 | ||||||||||
$ | 3,811,947 | $ | 2,479,749 | $ | 12,069,553 | $ | 7,883,071 | |||||||
Schedule of property and equipment, net information by geographic region | ' | |||||||||||||
September 30, | December 31, | |||||||||||||
2014 | 2013 | |||||||||||||
(unaudited) | ||||||||||||||
United States | $ | 685,463 | $ | 256,386 | ||||||||||
International | 69,804 | 70,957 | ||||||||||||
$ | 755,267 | $ | 327,343 | |||||||||||
Commitments_and_Contingencies_
Commitments and Contingencies (Tables) | 9 Months Ended | ||||
Sep. 30, 2014 | |||||
Commitments and Contingencies | ' | ||||
Summary of non-cancelable operating lease commitments | ' | ||||
Three months ending December 31, 2014 | $ | 97,749 | |||
2015 | 390,996 | ||||
2016 | 390,996 | ||||
2017 | 390,996 | ||||
2018 | 390,996 | ||||
2019 | 162,915 | ||||
Total non-cancelable operating lease commitments | $ | 1,824,648 | |||
Basis_of_Presentation_Details
Basis of Presentation (Details) (USD $) | 0 Months Ended | 9 Months Ended | 12 Months Ended | 3 Months Ended | |
Jul. 21, 2014 | Sep. 30, 2014 | Sep. 02, 2014 | Dec. 31, 2013 | Sep. 30, 2014 | |
item | Gross accounts receivable | Revenue | |||
Credit concentration risk | Customer concentration risk | ||||
Domestic customer | International customer | ||||
customer | customer | ||||
FDA Warning Letter | ' | ' | ' | ' | ' |
Number of observations | ' | ' | 8 | ' | ' |
Number of identified responses whose accuracy will be determined | ' | ' | 2 | ' | ' |
Initial Public Offering | ' | ' | ' | ' | ' |
Number of shares sold of common stock | 2,318,400 | ' | ' | ' | ' |
Number of shares sold to the underwriter for the exercise of over-allotment option | 302,400 | ' | ' | ' | ' |
Original issue price (in dollars per share) | $6.25 | ' | ' | ' | ' |
Net proceeds generated after deducting underwriting discounts and expenses | $12,400,000 | ' | ' | ' | ' |
Underwriting discounts and expenses | 2,000,000 | ' | ' | ' | ' |
Conversion ratio | 1 | 1.75 | ' | ' | ' |
Warrants up to the number of shares, underwriters can be purchase | 201,600 | ' | ' | ' | ' |
Fair value of warrants | $611,000 | ' | ' | ' | ' |
Exercise price of warrants (in dollars per share) | $8.13 | ' | ' | ' | ' |
Exercise price expressed as a percent of original issue price | 130.00% | ' | ' | ' | ' |
Certain Significant Risks and Uncertainties | ' | ' | ' | ' | ' |
Number of customers | ' | ' | ' | 1 | 2 |
Concentration risk (as a percent) | ' | ' | ' | 10.80% | 20.90% |
Basic_and_Diluted_Net_Income_p2
Basic and Diluted Net Income per Share (Details) (USD $) | 0 Months Ended | 3 Months Ended | 9 Months Ended | ||
Jul. 21, 2014 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Basic and Diluted Net Income per Share | ' | ' | ' | ' | ' |
Stock split ratio | 1 | ' | ' | 1.75 | ' |
Net income | ' | $237,357 | $260,675 | $1,779,545 | $1,462,910 |
Weighted-average shares outstanding - Basic (in shares) | ' | 10,112,139 | 7,000,000 | 8,048,779 | 7,000,000 |
Effect of dilutive securities: | ' | ' | ' | ' | ' |
Underwriters' warrants | ' | 847 | ' | ' | ' |
Preferred stock | ' | 228,261 | 1,400,000 | 1,005,128 | 1,400,000 |
Stock options | ' | 928,111 | 265,599 | 634,695 | 162,704 |
Weighted-average shares outstanding - Diluted (in shares) | ' | 11,269,358 | 8,665,599 | 9,688,602 | 8,562,704 |
Basic net income per share (in dollars per share) | ' | $0.02 | $0.04 | $0.22 | $0.21 |
Diluted net income per share (in dollars per share) | ' | $0.02 | $0.03 | $0.18 | $0.17 |
Anti-dilutive warrants and stock options (in shares) | ' | 17,625 | 357,158 | 660,159 | 789,933 |
Inventory_Details
Inventory (Details) (USD $) | 9 Months Ended | |
Sep. 30, 2014 | Dec. 31, 2013 | |
Inventory | ' | ' |
Raw materials | $1,427,014 | $1,143,495 |
Work in process | 91,448 | 14,337 |
Finished goods | 121,515 | 182,499 |
Total | 1,639,977 | 1,340,331 |
Allowance for excess and obsolete inventory | $36,709 | ' |
Property_and_Equipment_Details
Property and Equipment (Details) (USD $) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Dec. 31, 2013 | |
Property and equipment | ' | ' | ' | ' | ' |
Property and equipment, gross | $1,496,035 | ' | $1,496,035 | ' | $1,057,775 |
Accumulated depreciation | -740,768 | ' | -740,768 | ' | -730,432 |
Total | 755,267 | ' | 755,267 | ' | 327,343 |
Depreciation and amortization expense of property and equipment | 35,316 | 23,274 | 70,361 | 69,908 | ' |
Computer software and hardware | ' | ' | ' | ' | ' |
Property and equipment | ' | ' | ' | ' | ' |
Property and equipment, gross | 242,086 | ' | 242,086 | ' | 154,709 |
Furniture and fixtures | ' | ' | ' | ' | ' |
Property and equipment | ' | ' | ' | ' | ' |
Property and equipment, gross | 184,912 | ' | 184,912 | ' | 87,611 |
Leasehold improvements | ' | ' | ' | ' | ' |
Property and equipment | ' | ' | ' | ' | ' |
Property and equipment, gross | 168,844 | ' | 168,844 | ' | 47,623 |
Machinery and equipment | ' | ' | ' | ' | ' |
Property and equipment | ' | ' | ' | ' | ' |
Property and equipment, gross | 831,107 | ' | 831,107 | ' | 721,270 |
Tooling in-process | ' | ' | ' | ' | ' |
Property and equipment | ' | ' | ' | ' | ' |
Property and equipment, gross | $69,086 | ' | $69,086 | ' | $46,562 |
Intangible_Assets_Details
Intangible Assets (Details) (USD $) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Dec. 31, 2013 | |
Intangible assets | ' | ' | ' | ' | ' |
Intangible Assets, gross | $418,288 | ' | $418,288 | ' | $396,562 |
Accumulated amortization | -158,815 | ' | -158,815 | ' | -129,538 |
Total | 259,473 | ' | 259,473 | ' | 267,024 |
Amortization expense of intangible assets | 9,861 | 9,480 | 29,277 | 28,037 | ' |
Expected annual amortization expense | ' | ' | ' | ' | ' |
Three months ending December 31, 2014 | 9,861 | ' | 9,861 | ' | ' |
2015 | 39,446 | ' | 39,446 | ' | ' |
2016 | 22,143 | ' | 22,143 | ' | ' |
2017 | 14,665 | ' | 14,665 | ' | ' |
2018 | 14,665 | ' | 14,665 | ' | ' |
2019 | 14,665 | ' | 14,665 | ' | ' |
Patents - in use | ' | ' | ' | ' | ' |
Intangible assets | ' | ' | ' | ' | ' |
Intangible Assets, gross | 238,548 | ' | 238,548 | ' | 228,430 |
Patents - in process | ' | ' | ' | ' | ' |
Intangible assets | ' | ' | ' | ' | ' |
Intangible Assets, gross | 30,773 | ' | 30,773 | ' | 19,165 |
Internally developed software | ' | ' | ' | ' | ' |
Intangible assets | ' | ' | ' | ' | ' |
Intangible Assets, gross | $148,967 | ' | $148,967 | ' | $148,967 |
Capital_Stock_Details
Capital Stock (Details) (USD $) | 0 Months Ended | 9 Months Ended | 0 Months Ended | 12 Months Ended | 0 Months Ended | 0 Months Ended | 12 Months Ended | ||||||
Jul. 21, 2014 | Sep. 30, 2014 | Dec. 31, 2013 | Apr. 14, 2014 | Apr. 14, 2014 | Dec. 31, 2013 | Sep. 30, 2014 | Jul. 21, 2014 | Dec. 31, 2013 | Dec. 31, 2013 | Sep. 30, 2014 | Apr. 14, 2014 | Dec. 31, 2013 | |
Maximum | Common Stock | Common Stock | Common Stock | Common Stock | Class A Common Stock | Class B Common Stock | Preferred Stock | Series A Preferred Stock | Series A Preferred Stock | ||||
IPO | |||||||||||||
Capital Stock | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Conversion ratio | 1 | 1.75 | ' | ' | 1.75 | 1.75 | ' | 1 | ' | ' | ' | 1.75 | 1.75 |
Aggregate public offering amount | ' | ' | ' | $10,000,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Preferred stock outstanding - Pre recapitalization | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | 800,000 |
Preferred stock outstanding - Post recapitalization | ' | 0 | 1,400,000 | ' | ' | ' | ' | ' | ' | ' | ' | ' | 1,400,000 |
Common stock shares outstanding - Pre recapitalization | ' | ' | ' | ' | ' | 4,000,000 | ' | ' | 400,000 | 3,600,000 | ' | ' | ' |
Common stock shares outstanding - Post recapitalization | ' | 10,718,400 | 7,000,000 | ' | ' | 7,000,000 | ' | ' | ' | ' | ' | ' | ' |
Common stock, shares authorized | ' | 90,000,000 | 90,000,000 | ' | ' | ' | 90,000,000 | ' | ' | ' | ' | ' | ' |
Common stock, par value (in dollars per share) | ' | $0.00 | $0.00 | ' | ' | ' | $0.00 | ' | ' | ' | ' | ' | ' |
Preferred stock, shares authorized | ' | 10,000,000 | 10,000,000 | ' | ' | ' | ' | ' | ' | ' | 10,000,000 | ' | ' |
Preferred stock, par value (in dollars per share) | ' | $0.00 | $0.00 | ' | ' | ' | ' | ' | ' | ' | $0.00 | ' | ' |
StockBased_Compensation_Detail
Stock-Based Compensation (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Stock Based Compensation | ' | ' | ' | ' |
Stock based compensation | $171,599 | $67,980 | $503,881 | $203,939 |
Total unrecognized stock based compensation expense | 2,000,945 | ' | 2,000,945 | ' |
Weighted average period expected to be recognized | ' | ' | '3 years | ' |
Cost of revenue. | ' | ' | ' | ' |
Stock Based Compensation | ' | ' | ' | ' |
Stock based compensation | 905 | 3 | 2,834 | 10 |
General and administrative | ' | ' | ' | ' |
Stock Based Compensation | ' | ' | ' | ' |
Stock based compensation | 60,235 | 4,115 | 174,737 | 12,345 |
Sales and marketing | ' | ' | ' | ' |
Stock Based Compensation | ' | ' | ' | ' |
Stock based compensation | 102,606 | 63,775 | 299,594 | 191,322 |
Research and development | ' | ' | ' | ' |
Stock Based Compensation | ' | ' | ' | ' |
Stock based compensation | $7,853 | $87 | $26,716 | $262 |
StockBased_Compensation_Detail1
Stock-Based Compensation (Details 2) (Options) | 9 Months Ended |
Sep. 30, 2014 | |
Options | ' |
Options | ' |
Outstanding at the beginning of the period (in shares) | 1,759,692 |
Options granted (in shares) | 108,750 |
Options exercised (in shares) | 0 |
Options canceled (in shares) | 0 |
Outstanding at the end of the period (in shares) | 1,868,442 |
Investments_Details
Investments (Details) (USD $) | 12 Months Ended |
Dec. 31, 2013 | |
item | |
Investments | ' |
Number of mutual funds | 2 |
Cost | $244,782 |
Gross Unrealized Gains | 1,421 |
Gross Unrealized Losses | 0 |
Market Value | $246,203 |
Fair_Value_Measurements_Detail
Fair Value Measurements (Details) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
Fair Value Measurements | ' | ' |
Fair value assets, amount transferred between measurement levels | $0 | $0 |
Recurring | Fair Value | ' | ' |
Fair Value Measurements | ' | ' |
Mutual funds | ' | 246,203 |
Recurring | Quoted Prices in Active Market for Identical Assets (Level 1) | ' | ' |
Fair Value Measurements | ' | ' |
Mutual funds | ' | $246,203 |
Income_Taxes_Details
Income Taxes (Details) (USD $) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | |
Income Taxes | ' | ' | ' | ' |
Provisions for income taxes | $160,143 | $113,983 | $1,067,242 | $639,678 |
Effective tax rate (as a percent) | 40.30% | 30.40% | 37.50% | 30.40% |
Increase in the effective tax rate due to higher U.S. state tax expense (as a percent) | ' | ' | 4.80% | ' |
Decrease in effective tax rate due to domestic production activities deduction (as a percent) | ' | ' | 2.20% | ' |
Decrease in effective tax rate due to domestic production activities deduction and research and development tax credit (as a percent) | ' | ' | ' | 6.50% |
Increase in the effective tax rate due to negative impact of higher U.S. state tax expense (as a percent) | ' | ' | ' | 2.30% |
Segment_Customer_and_Geographi2
Segment, Customer and Geographic Information (Details) (USD $) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Dec. 31, 2013 | |
item | |||||
Segment, Customer and Geographic Information | ' | ' | ' | ' | ' |
Number of reportable segment | ' | ' | 1 | ' | ' |
Segment, Customer and Geographic Information | ' | ' | ' | ' | ' |
Revenue | $3,811,947 | $2,479,749 | $12,069,553 | $7,883,071 | ' |
Property and equipment, net | 755,267 | ' | 755,267 | ' | 327,343 |
Devices | ' | ' | ' | ' | ' |
Segment, Customer and Geographic Information | ' | ' | ' | ' | ' |
Revenue | 3,125,189 | 2,012,978 | 10,174,816 | 6,386,505 | ' |
Disposable IV sets and services | ' | ' | ' | ' | ' |
Segment, Customer and Geographic Information | ' | ' | ' | ' | ' |
Revenue | 686,758 | 466,771 | 1,894,737 | 1,496,566 | ' |
United States | ' | ' | ' | ' | ' |
Segment, Customer and Geographic Information | ' | ' | ' | ' | ' |
Revenue | 3,529,024 | 1,654,100 | 10,195,841 | 5,490,016 | ' |
Property and equipment, net | 685,463 | ' | 685,463 | ' | 256,386 |
International | ' | ' | ' | ' | ' |
Segment, Customer and Geographic Information | ' | ' | ' | ' | ' |
Revenue | 282,923 | 825,649 | 1,873,712 | 2,393,055 | ' |
Property and equipment, net | $69,804 | ' | $69,804 | ' | $70,957 |
International | MRI compatible IV infusion pumps | ' | ' | ' | ' | ' |
Segment, Customer and Geographic Information | ' | ' | ' | ' | ' |
Number of customers | ' | 2 | ' | ' | ' |
Revenue from sale of products (as a percent) | ' | 20.90% | ' | ' | ' |
Commitments_and_Contingencies_1
Commitments and Contingencies (Details) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 | Jan. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 |
Susi, LLC | Susi, LLC | Susi, LLC | Susi, LLC | Susi, LLC | |||
Winter Springs, Florida Facility | Winter Springs, Florida Facility | Winter Springs, Florida Facility | Winter Springs, Florida Facility | Winter Springs, Florida Facility | |||
Leases | ' | ' | ' | ' | ' | ' | ' |
Monthly base rent | ' | ' | $32,583 | ' | ' | ' | ' |
Number of successive renewal term of lease | ' | ' | '2 years | ' | ' | ' | ' |
Renewal term of lease beginning in 2019 | ' | ' | '5 years | ' | ' | ' | ' |
Renewal term of lease beginning in 2024 | ' | ' | '5 years | ' | ' | ' | ' |
Renewal term lease thereafter | ' | ' | '1 year | ' | ' | ' | ' |
Non-cancelable operating lease commitments | ' | ' | ' | ' | ' | ' | ' |
Three months ending December 31, 2014 | ' | ' | ' | 97,749 | ' | 97,749 | ' |
2015 | ' | ' | ' | 390,996 | ' | 390,996 | ' |
2016 | ' | ' | ' | 390,996 | ' | 390,996 | ' |
2017 | ' | ' | ' | 390,996 | ' | 390,996 | ' |
2018 | ' | ' | ' | 390,996 | ' | 390,996 | ' |
2019 | ' | ' | ' | 162,915 | ' | 162,915 | ' |
Total non-cancelable operating lease commitments | ' | ' | ' | 1,824,648 | ' | 1,824,648 | ' |
Rent expense | ' | ' | ' | 108,047 | 28,171 | 170,968 | 85,886 |
Purchase commitments | ' | ' | ' | ' | ' | ' | ' |
Purchase commitments | $2,038,196 | $1,758,242 | ' | ' | ' | ' | ' |
Commitments_and_Contingencies_2
Commitments and Contingencies (Details 2) (Uncommitted revolving credit facility, USD $) | Sep. 30, 2014 | Jun. 30, 2014 |
Uncommitted revolving credit facility | ' | ' |
Uncommitted Revolving Credit Facility | ' | ' |
Maximum borrowing capacity with the now terminated facility | $0 | $100,000 |
Related_Party_Transactions_Det
Related Party Transactions (Details) (USD $) | Dec. 31, 2013 | Dec. 31, 2013 | Sep. 30, 2014 | Sep. 30, 2014 |
CEO | Wife of CEO | Wife of CEO | ||
Amount outstanding on note payable | $6,333 | $6,333 | ' | ' |
Expenses for various services | ' | ' | $12,200 | $18,114 |