UNITED STATES 

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the Quarterly Period Ended March 31, 2019

 

OR

 

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from ____________ to ____________

 

Commission File Number: 001-37714

 

Sensus Healthcare, Inc. 

(Exact name of registrant as specified in its charter)

 

Delaware 27-1647271
(State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.)
   
851 Broken Sound Pkwy., NW #215, Boca Raton, Florida 33487
(Address of principal executive office) Zip Code)

 

(561) 922-5808

(Registrant’s telephone number, including area code)

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒  No ☐

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒  No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an “emerging growth company”. See definitions of “large accelerated filer”, “accelerated filer”, and “smaller reporting company” and an “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☐ Smaller reporting company ☒
       
   

(Do not check if smaller

reporting company)

Emerging growth company ☒

  

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class Trading Symbol(s) Name of each exchange on which registered
Common Stock, par value $0.01 per share SRTS Nasdaq Stock Market, LLC
Warrants to Purchase Common Stock (exp. June 8, 2019) SRTSW Nasdaq Stock Market, LLC

 

As of April 30, 2019, 16,518,242 shares of the Registrant’s Common Stock, $0.01 par value, were outstanding.

 

 

 

 

SENSUS HEALTHCARE, INC.

QUARTERLY REPORT ON FORM 10-Q

TABLE OF CONTENTS

 

    Page
PART I – Financial Information  
     
Item 1. Condensed Consolidated Financial Statements (Unaudited)  
  Balance Sheets as of March 31, 2019 and December 31, 2018 5
  Statements of Operations for the Three Months Ended March 31, 2019 and 2018 6
  Statements of Stockholders’ Equity for the Three Months Ended March 31, 2019 and 2018 7
  Statements of Cash Flows for the Three Months Ended March 31, 2019 and 2018 8
  Notes to the Condensed Consolidated Financial Statements 9
     
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 18
     
Item 3. Quantitative and Qualitative Disclosures about Market Risk 22
     
Item 4. Controls and Procedures 22
     
PART II – Other Information  
     
Item 1. Legal Proceedings 22
     
Item 1A. Risk Factors 22
     
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 23
     
Item 3. Defaults Upon Senior Securities 23
     
Item 4. Mine Safety Disclosure 23
     
Item 5. Other Information 23
     
Item 6. Exhibits 23
     
Signatures 24

 

2 

 

 

INTRODUCTORY NOTE

 

Caution Concerning Forward-Looking Statements

 

This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements about our beliefs, plans, objectives, goals, expectations, estimates and intentions that are subject to significant risks and uncertainties and are subject to change based on various factors, many of which are beyond our control. The words “may,” “could,” “should,” “would,” “will,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended to identify forward-looking statements.

 

All forward-looking statements, by their nature, are subject to risks and uncertainties. Our actual future results may differ materially from those set forth in our forward-looking statements.

 

Our ability to achieve our financial objectives could be adversely affected by the factors discussed in detail in Part I, Item 2. “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and Part II, Item 1A. “Risk Factors” in this Quarterly Report on Form 10-Q and in our Annual Report on Form 10-K, as well as:

  

  our ability to achieve and sustain profitability;
  market acceptance of our products;
  our ability to successfully commercialize our products;
  our ability to compete effectively in selling our products and services, including responding to technological change and cost containment efforts of our customers;
  the regulatory requirements applicable to us and our competitors, including any adverse regulatory action taken against us;
  our need and ability to obtain additional financing in the future, as well as complying with the restrictions our existing revolving credit facility imposes;
  our ability to expand, manage and maintain our direct sales and marketing organizations;
  our actual financial results may vary significantly from forecasts and from period to period;
  our ability to successfully develop new products, improve or enhance existing products or acquire
  complementary products, technologies, services or businesses;
  our ability to obtain and maintain intellectual property of sufficient scope to adequately protect our products, including the SRT-100, and our ability to avoid infringing or otherwise violating the intellectual property rights of third parties;
  market risks regarding consolidation in the healthcare industry;
  the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing from
    third party payors for procedures using our products declines;
  the level and availability of government and third-party payor reimbursement for clinical procedures using our products;
  our ability to effectively manage our anticipated growth, including hiring and retaining qualified personnel;
  our ability to manufacture our products to meet demand;
  our reliance on third party manufacturers and sole- or single-source suppliers;
  our ability to reduce the per unit manufacturing cost of our products;
  our ability to efficiently manage our manufacturing processes;
    the regulatory and legal risks, and certain operating risks, that our international operations subject us to;
    off label use of our products;
  information technology risks including the risk from cyberattack;
  the fact that product quality issues or product defects may harm our business;
    the accuracy of our financial statements and accounting estimates, including allowances for accounts receivable and inventory obsolescence;
  any product liability claims;
  limited trading in our shares and the concentration of ownership of our shares;
  cyberattacks and other data breaches and the adverse effect on our reputation;
  new legislation, administrative rules, or executive orders, including those that impact taxes and international trade regulation;

 

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  the provisions in our certificate of incorporation, bylaws, or Delaware law that discourage takeovers or that limit certain disputes to be brought exclusively in the Delaware Court of Chancery; the concentration of sales in our customers in the U.S. and China; and
  our ability to manage the risk of the foregoing.

 

However, other factors besides those listed in Item 1A Risk Factors in our Annual Report on Form 10-K or discussed in this Form 10-Q also could adversely affect our results, and you should not consider any such list of factors to be a complete set of all potential risks or uncertainties. Any forward-looking statements made by us or on our behalf speak only as of the date they are made. We do not undertake to update any forward-looking statement, except as required by applicable law.

 

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PART I. FINANCIAL INFORMATION

 

Item 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

SENSUS HEALTHCARE, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS

 

   As of
March 31,
   As of
December 31,
 
   2019   2018 
    (unaudited)      
Assets          
Current Assets          
Cash and cash equivalents  $6,251,884   $12,484,256 
Accounts receivable, net   16,881,672    13,145,934 
Inventories   1,551,419    1,628,817 
Investment in debt securities   4,699,954    2,892,190 
Prepaid and other current assets   2,252,755    1,750,994 
Total Current Assets   31,637,684    31,902,191 
Property and Equipment, Net   899,792    891,029 
Patent Rights, Net   409,640    433,737 
Deposits   24,272    24,272 
Operating Lease Right-of-Use Assets, Net   749,114     
Total Assets  $33,720,502   $33,251,229 
Liabilities and Stockholders’ Equity          
Current Liabilities          
Accounts payable and accrued expenses  $4,075,214   $5,166,239 
Deferred revenue, current portion   744,996    722,025 
Operating lease liabilities, current portion   240,972     
Product warranties   137,942    136,217 
Total Current Liabilities   5,199,124    6,024,481 
Operating Lease Liabilities   510,784     
Deferred Revenue, Net of Current Portion   815,164    766,732 
Total Liabilities   6,525,072    6,791,213 
Commitments and Contingencies          
Stockholders’ Equity          
Preferred stock, 5,000,000 shares authorized and none issued and outstanding        
Common stock, $0.01 par value – 50,000,000 authorized; 16,546,196 issued and 16,512,742 outstanding at March 31, 2019; 16,145,915 issued and 16,112,461 outstanding at December 31, 2018   165,461    161,459 
Additional paid-in capital   42,810,335    39,957,905 
Treasury stock, 33,454 shares at cost, at March 31, 2019 and December 31, 2018, respectively   (133,816)   (133,816)
Accumulated deficit   (15,646,550)   (13,525,532)
Total Stockholders’ Equity   27,195,430    26,460,016 
Total Liabilities and Stockholders’ Equity  $33,720,502   $33,251,229 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

5 

 

 

SENSUS HEALTHCARE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

 

   For the Three Months Ended 
March 31,
 
   2019   2018 
         
Revenues  $5,436,599   $5,955,462 
Cost of Sales   2,120,621    2,015,200 
Gross Profit   3,315,978    3,940,262 
Operating Expenses          
Selling and marketing   2,530,346    2,214,911 
General and administrative   1,013,162    1,342,253 
Research and development   1,965,507    1,497,618 
Total Operating Expenses   5,509,015    5,054,782 
Loss From Operations   (2,193,037)   (1,114,520)
Other Income (Expense)          
Interest income   72,020    22,022 
Interest expense       (33,415)
Other Income (Expense), net   72,020    (11,393)
Net Loss  $(2,121,018)  $(1,125,913)
Net Loss per share – basic and diluted  $(0.13)  $(0.08)
Weighted average number of shares used in computing net loss per share – basic and diluted   16,119,726    13,331,553 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

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SENSUS HEALTHCARE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

FOR THE THREE MONTHS ENDED MARCH 31, 2018 AND 2019

 

       Additional             
   Common Stock   Paid-In   Treasury Stock   Accumulated     
   Shares   Amount   Capital   Shares   Amount   Deficit   Total 
December 31, 2017   13,522,168   $135,221   $23,181,641    (33,454)  $(133,816)  $(11,502,771)  $11,680,275 
Stock based compensation   50,000    500    541,108                541,608 
Exercise of warrants   29,288    293    90,574                90,867 
Net loss                       (1,125,913)   (1,125,913)
March 31, 2018   13,601,456    136,014   $23,813,323    (33,454)  $(133,816)  $(12,628,684)  $11,186,837 
(unaudited)                                   
                                    
December 31, 2018   16,145,915   $161,459   $39,957,905    (33,454)  $(133,816)  $(13,525,532)  $26,460,016 
Stock based compensation           154,535                154,535 
Exercise of warrants   400,281    4,002    2,697,895                2,701,897 
Net loss                       (2,121,018)   (2,121,018)
March 31, 2019   16,546,196   $165,461   $42,810,335    (33,454)  $(133,816)  $(15,646,550)  $27,195,430 
(unaudited)                                   

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

7 

 

 

SENSUS HEALTHCARE, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

 

   For the Three Months Ended 
March 31,
 
   2019   2018 
Cash Flows From Operating Activities          
Net loss  $(2,121,018)  $(1,125,913)
Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:          
Bad debt expense (recovery)       2,345 
Depreciation and amortization   128,435    100,534 
Provision for product warranties   59,638    36,790 
Stock based compensation   154,535    541,608 
Decrease (increase) in:          
Accounts receivable   (3,735,738)   (3,107,036)
Inventories   (26,299)   (62,071)
Prepaid and other current assets   (445,874)   86,775 
Increase (decrease) in:          
Accounts payable and accrued expenses   (1,144,269)   87,870 
Deferred revenue   71,402    5,005 
Product warranties   (57,913)   (43,467)
Total Adjustments   (4,996,083)   (2,351,647)
Net Cash Used In Operating Activities   (7,117,101)   (3,477,560)
Cash Flows from Investing Activities          
Acquisition of property and equipment   (9,404)   (287,594)
Investment in debt securities - held to maturity   (3,007,764)    
Investments matured   1,200,000    1,104,635 
Net Cash Provided By (Used) In Investing Activities   (1,817,168)   817,041 
Cash Flows from Financing Activities          
Revolving credit facility, net       2,000,663 
Exercise of warrants   2,701,897    90,867 
Net Cash Provided By Financing Activities   2,701,897    2,091,530 
Net Decrease in Cash and Cash Equivalents   (6,232,372)   (568,991)
Cash and Cash Equivalents – Beginning   12,484,256    10,085,468 
Cash and Cash Equivalents – Ending  $6,251,884   $9,516,479 
Supplemental Disclosure of Cash Flow Information          
Interest Paid  $   $33,415 
Non-Cash Investing and Financing Activities          
Transfer of inventory to property and equipment  $103,697     
Lease liabilities arising from obtaining right-of-use-assets  $805,000   $ 

 

See accompanying notes to the unaudited condensed consolidated financial statements.

 

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SENSUS HEALTHCARE, INC.
NOTES TO THE FINANCIAL STATEMENTS

 

(unaudited)

 

Note 1 — Organization and Summary of Significant Accounting Policies

 

Description of the Business

 

Sensus Healthcare, Inc. (the “Company”) is a manufacturer of radiation therapy devices and has established a distribution and marketing network to sell the devices to healthcare providers globally. The Company was organized on May 7, 2010 as a limited liability corporation. On January 1, 2016, the Company completed a corporate conversion pursuant to which Sensus Healthcare, Inc. succeeded to the business of Sensus Healthcare, LLC. In February 2018, the Company opened a subsidiary in Israel. The Company operates as one segment from its corporate headquarters located in Boca Raton, Florida.

 

Basis of Presentation

 

The accompanying unaudited condensed financial statements in this Quarterly Report on Form 10-Q have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, and the rules and regulations of the U.S. Securities and Exchange Commission, or SEC. Accordingly, they do not include certain footnotes and financial presentations normally required under accounting principles generally accepted in the United States of America for complete financial statements. The interim financial information is unaudited, but reflects all normal adjustments and accruals which are, in the opinion of management, considered necessary to provide a fair presentation for the interim periods presented. The accompanying condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto for the year ended December 31, 2018 included in the Company’s Form 10-K, filed with the SEC. The results for the three months ended March 31, 2019 are not necessarily indicative of results to be expected for the year ending December 31, 2019, any other interim periods, or any future year or period.

 

Principles of consolidation

 

The accompanying condensed consolidated financial statements include the financial statements of the Company and its wholly-owned subsidiary in Israel. All inter-company balances and transactions have been eliminated.

 

Use of Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates to which it is reasonably possible that a change could occur in the near term include, inventory reserves, receivable allowances, recoverability of long-lived assets and estimation of the Company’s product warranties. Actual results could differ from those estimates.

 

Revenue Recognition

 

On January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modified retrospective method for all contracts as of the date of adoption. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there were no necessary adjustments required to retained earnings upon adoption.

 

Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to a customer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services, which is generally upon shipment of the goods and performance of the service. The amount of revenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, a contract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performance obligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performance obligation.

 

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The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of the devices and the service contract are usually signed at the same time and in some instances a service contract is signed on a stand-alone basis. Revenue for service contracts is recognized over the service contract period on a straight-line basis. The Company determined that in practice no significant discount is given on the service contract when it is offered with the device purchase as compared to when it is sold on a stand-alone basis, by comparing the median selling price of the service contract as stand-alone and the median selling price of the service contract when sold together with the device. The service level provided is identical when the service contract is purchased stand-alone or together with the device. There is no termination provision in the service contract nor any penalties in practice for cancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for a significant discount when purchased with the device. The service portion of a sales contract or a stand-alone service contract is accounted for over the period of time of the service contract only when the customer exercises the option by paying for the service contract.

 

Disaggregated revenue for the three months ended March 31, 2019 and 2018 was as follows:

 

   For the Three Months Ended 
March 31,
 
   2019   2018 
Product Revenue  $4,930,924   $5,532,647 
Service Revenue   505,675    422,815 
Total Revenue  $5,436,599   $5,955,462 

 

The Company operates in a highly regulated environment in which state regulatory approval is sometimes required prior to the customer being able to use the product, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval is obtained.

 

Deferred revenue as of March 31, 2019 was as follows:

 

   Service   Product   Total Deferred Revenue 
Balance, beginning of period  $1,455,757   $33,000   $1,488,757 
Revenue recognized   (368,956)   (33,000)   (401,956)
Amounts invoiced   473,359        473,359 
Balance, end of period  $1,560,160   $   $1,560,160 

 

The Company does not disclose information about remaining performance obligations of deposits for products that have original expected durations of one year or less. Estimated service revenue to be recognized in the future related to the performance obligations that are unsatisfied (or partially unsatisfied) as of March 31, 2019 is as follows:

 

Year  Service Revenue 
2019 (April 1 – December 31, 2019)  $579,785 
2020   539,914 
2021   405,892 
2022   34,569 
Total  $1,560,160 

 

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The Company provides warranties in conjunction with the sale of its products. These warranties entitle the customer to repair, replacement, or modification of the defective product subject to the terms of the respective warranty. The Company records an estimate of future warranty claims at the time the Company recognizes revenue from the sale of the product based upon management’s estimate of the future claims rate.

 

Shipping and handling costs are expensed as incurred and are included in cost of sales.

 

Segment and Geographical Information

 

The Company’s revenue is generated primarily from customers in the United States, which represented approximately 81% and 100% for the three months ended March 31, 2019 and 2018, respectively. A single customer in the US accounted for approximately 53% and 75% of revenues for the three months ended March 31, 2019 and 2018, respectively, and approximately 87% of the accounts receivable as of March 31, 2019 and December 31, 2018, respectively.

 

Cash and Cash Equivalents

 

The Company maintains its cash and cash equivalents with financial institutions which balances exceed the federally insured limits. Federally insured limits are $250,000 for deposits. As of March 31, 2019 and December 31, 2018, the Company had approximately $5,679,000 and $11,726,000, respectively in excess of federally insured limits.

 

For purposes of the statement of cash flows, the Company considers all highly liquid financial instruments with a maturity of three months or less when purchased to be a cash equivalent.

 

Investments

 

Short-term investments consist of investments which the Company expects to convert into cash within one year and long-term investments after one year. The Company classifies its investments in debt securities at the time of purchase as held-to-maturity and reevaluates such classification on a quarterly basis. Held-to-maturity investments consist of securities that the Company has the intent and ability to retain until maturity. These securities are carried at amortized cost plus accrued interest and consist of the following:

 

   Amortized
Cost
   Gross
Unrealized
Gain
   Gross
Unrealized
Loss
   Fair
Value
 
Short-Term:                    
Corporate bonds  $2,892,190   $   $623   $2,891,567 
Total Short Term:   2,892,190        623    2,891,567 
                     
Total Investments December 31, 2018  $2,892,190   $   $623   $2,891,567 
                     
Short-Term:                    
Corporate bonds  $4,699,954   $1,226   $   $4,701,180 
Total Short Term:   4,699,954    1,226        4,701,180 
                     
Total Investments March 31, 2019  $4,699,954   $1,226   $   $4,701,180 

 

Accounts Receivable

 

The Company does business and extends credit based on an evaluation of each customer’s financial condition, generally without requiring collateral. Exposure to losses on receivables is expected to vary by customer due to the financial condition of each customer. The Company monitors exposure to credit losses and maintains allowances for anticipated losses considered necessary under the circumstances. The allowance for doubtful accounts was $0 as of March 31, 2019 and December 31, 2018. Bad debt expense for the three months ended March 31, 2019 and 2018 was approximately $0 and $2,000, respectively.

 

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Inventories

 

Inventories consist of finished product and components and are stated at the lower of cost or net realizable value, determined using the first-in-first-out method.

 

Earnings Per Share

 

Basic net income (loss) per share is calculated by dividing the net income (loss) by the weighted-average number of common shares outstanding for the period. The diluted net income per share is computed by giving effect to all potential dilutive common share equivalents outstanding for the period, using the treasury stock method for options and warrants, as well as unvested restricted shares. In periods when the Company has incurred a net loss, options, warrants and unvested shares are considered common share equivalents but have been excluded from the calculation of diluted net loss per share as their effect is antidilutive. Shares were excluded as follows:

 

   For the Three Months Ended 
March 31,
 
   2019   2018 
Warrants   256,035     
Stock options   64,463    3,660 
Shares   70,951     

 

Advertising Costs

 

Advertising and promotion expenses are charged to expense as incurred. Advertising and promotion expense included in selling expense in the accompanying statements of operations amounted to approximately $539,000 and $522,000 for the three months ended March 31, 2019 and 2018, respectively.

 

Leases

 

The Company evaluates arrangements at inception to determine if an arrangement is or contains a lease. Operating lease assets represent the Company’s right to use an underlying asset for the lease term and operating lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease assets and liabilities are recognized at the commencement date of the lease based upon the present value of lease payments over the lease term. When determining the lease term, the Company includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. The Company uses an incremental borrowing rate that the Company would expect to incur for a fully collateralized loan over a similar term under similar economic conditions to determine the present value of the lease payments.

 

The lease payments used to determine the Company’s operating lease assets may include lease incentives and stated rent increases and are recognized in the Company’s operating lease assets in the Company’s condensed consolidated balance sheets. Operating lease assets are amortized to rent expense over the lease term and included in operating expenses in the condensed consolidated statements of operations.

 

Recently issued and Adopted accounting Standards

 

In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842).” The guidance in ASU 2016-02 supersedes the lease recognition requirements in ASC Topic 840, Leases (FAS 13). The new standard establishes a right-of-use (“ROU”) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The new standard is effective for fiscal years beginning after December 1, 2018, including interim periods within those fiscal years, with early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. Early adoption of the amendments in the update is permitted. The Company adopted this standard in the first quarter of 2019 using the modified retrospective approach. The adoption of this standard resulted in the recognition of operating lease right-of-use assets and associated lease liabilities on our balance sheet of approximately $805,000 and $805,000, respectively, as of January 1, 2019. Additional required disclosures have been included within Note 6 - Leases. Such adoption did not have a material impact on our liquidity, results of operations or our compliance with the revolving credit facility covenants.

 

12

 

 

Note 2 — Property and Equipment

 

   As of March 31, 2019   As of December 31, 2018   Estimated Useful Lives  
   (unaudited)           
Operations equipment  $854,302   $852,273   3 years  
Tradeshow and demo equipment   890,929    784,244   3 years  
Computer equipment   117,666    112,521   3 years  
    1,862,897    1,749,038      
Less accumulated depreciation   (963,105)   (858,009)     
Property and Equipment, Net  $899,792   $891,029      

 

Depreciation expense was approximately $104,000 and $76,000, for the three months ended March 31, 2019 and 2018, respectively.

 

Note 3 — Patent Rights 

 

   As of March 31,   As of December 31, 
   2019   2018 
   (unaudited)      
Gross carrying amount  $1,253,018   $1,253,018 
Less accumulated amortization   (843,378)   (819,281)
Patent Rights, Net  $409,640   $433,737 

 

Amortization expense was approximately $24,000 for the three months ended March 31, 2019 and 2018. As of March 31, 2019, future remaining amortization expense is as follows:

 

Year    
2019 (April 1 – December 31, 2019)  $72,290 
2020   96,386 
2021   96,386 
2022   96,386 
2023   48,192 
Total  $409,640 

 

Note 4 — Revolving Credit Facility

 

On October 31, 2017, the Company amended its revolving credit facility to extend the maturity to October 31, 2019 and to amend the financial covenants. The availability under the amended facility will equal the lesser of the $5 million commitment amount or the borrowing base plus the $2.5 million non-formula sublimit. The borrowing base consists of 80% of eligible accounts receivable, as defined in the agreement.

 

Interest, at Prime plus 0.75% (6.25% at March 31, 2019) and Prime plus 1.50% on non-formula borrowings (7.00% at March 31, 2019), is payable monthly, and the outstanding principal and interest are due on the maturity date. The facility is secured by all of the Company’s assets and limits the amount of additional indebtedness, restricts the sale, disposition or transfer of assets of the Company and requires the maintenance of a certain monthly adjusted quick ratio restrictive covenant, as defined in the agreement. The Company was in compliance with its financial covenants as of March 31, 2019 and December 31, 2018. There were no borrowings outstanding under the revolving credit facility at March 31, 2019 and December 31, 2018. The Company pays commitment fees of 0.25% per annum on the average unused portion of the line of credit.

 

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Note 5 — Product Warranties

 

Changes in product warranty liability were as follows for the nine months ended March 31, 2019:

 

Balance, beginning of period  $136,217 
Warranties accrued during the period   59,638 
Payments on warranty claims   (57,913)
Balance, end of period  $137,942 

 

Note 6 — Leases

 

Operating Lease Agreements

 

In July 2016, the Company renewed its lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded the office space being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, the Company signed amendments to expand further the leased office space. The Company’s Israeli subsidiary entered into a two-year lease for office space starting in September 2018. The leases include an option to extend with prior notice and with terms to be negotiated. The Company currently does not have any lease with a term under 12 months.

 

On March 19, 2019, the Company’s Israeli subsidiary signed a 10-year lease for a manufacturing facility, effective April 1, for approximately 5,800 square feet. The landlord has provided a four-month grace period rent free from April to July 2019, after which the 10 year lease will begin. The monthly rental payment starts at approximately $5,300 and will be subject to periodic escalations at amounts specified in the lease plus the consumer price index. In addition, the Company is responsible for maintenance fees covering its portion of the expenses of common areas. After 2, 4, 6 and 8 years, and with 180 days prior notice, the Company has the right to terminate the lease at its sole discretion with no penalty.

 

The following table presents information about the amount, timing and uncertainty of cash flows arising from the Company’s operating leases as of March 31, 2019.

 

Maturity of Operating Lease Liabilities  Amount 
2019 (April 1 – December 31, 2019)  $187,420 
2020   245,237 
2021   230,674 
2022   176,866 
Total undiscounted operating leases payments  $840,197 
Less: Imputed interest   (88,441)
Present Value of Operating Lease Liabilities  $751,756 
      
Other Information     
Weighted-average remaining lease term   3.3 years 
Weighted-average discount rate   5.0%

 

An initial ROU asset of approximately $805,000 was recognized as a non-cash assets addition with the adoption of the new lease accounting standard. The ROU asset was reduced by approximately $56,000 during the three months ended March 31, 2019. Cash paid for amounts included in the present value of operating lease liabilities was approximately $62,000 for the three months ended March 31, 2019 and is included in operating cash flows. Operating lease cost was approximately $65,000 for the three months ended March 31, 2019.

 

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Note 7 — Commitments and Contingencies

 

Manufacturing Agreement

 

In July 2010, the Company entered into a three-year contract manufacturing agreement with an unrelated third party for the production and manufacture of the SRT-100, the Company’s main product in accordance with the Company’s product specifications. The agreement renews for successive one-year periods unless either party notifies the other party in writing, at least 60 days prior to the anniversary date of this agreement that it will not renew the agreement. The Company or the manufacturer has the option to terminate the agreement upon 90 days written notice. Any change in the relationship with the manufacturer could have an adverse effect on the Company’s business.

 

Purchases from this manufacturer totaled approximately $1,911,000 and $1,137,000 for the three months ended March 31, 2019 and 2018, respectively. As of March 31, 2019, and December 31, 2018 approximately $663,000 and $1,041,000, respectively, was due to this manufacturer, which is presented in accounts payable and accrued expenses in the accompanying balance sheets.

 

Legal contingencies

 

The Company is party to certain legal proceedings in the ordinary course of business. The Company assesses, in conjunction with its legal counsel, the need to record a liability for litigation and related contingencies.

 

In November 2015, the Company learned that the Department of Justice (the “Department”) had commenced an investigation of the billing to Medicare by a physician who had treated patients with the Company’s SRT-100. The Company received a Civil Investigative Demand from the Department seeking documents and written responses in connection with that investigation. The Company has fully cooperated with the investigation. The Department has advised the Company that it was considering expanding the investigation to determine whether the Company had any involvement in the physician’s use of certain reimbursement codes. The Company disputes that it has engaged in any wrongdoing with respect to such reimbursement claims; among other things, the Company does not submit claims for reimbursement or provide coding or billing advice to physicians. To the Company’s knowledge, the Department has made no determination as to whether the Company engaged in any wrongdoing, or whether to pursue any legal action against the Company. Should the Department decide to pursue legal action, the Company believes it has strong and meritorious defenses and will vigorously defend itself. At this time, the Company is unable to estimate the cost associated with this matter.

 

Note 8 — Employee Benefit Plans

 

We sponsor a 401(k) defined contribution retirement plan that allows eligible employees to contribute a portion of their compensation through payroll deductions in accordance with specified plan guidelines. We make contributions to the plans that include matching a percentage of the employees’ contributions up to certain limits. Expenses related to this plan totaled approximately $28,000 and $24,000 for the three months ended March 31, 2019 and 2018, respectively.

 

Note 9 — Stockholders’ Equity

 

The Company has authorized 50,000,000 shares of common stock, of which 16,546,196 were issued and 16,512,742 outstanding at March 31, 2019; 16,145,915 shares were issued and 16,112,461 were outstanding as of December 31, 2018.

 

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Warrants

 

In April 2013, the closing date of the Company’s second common offering, the Company’s placement agent received investor rights to 5 year warrants to purchase 86,376 common shares of the Company at an exercise price of $4.55 per unit, which was equal to 110% of the offering price. During the first quarter of 2018, 73,309 of the warrants were exercised, and 13,067 warrants expired.

 

In June 2016, from the Company’s IPO, the investors received three-year warrants to purchase 2,300,000 shares of common stock at an exercise price of $6.75 per share; the warrants are exercisable through June 2, 2019. Following the first anniversary of the date of issuance, if certain conditions are met, the Company may redeem any and all of the outstanding warrants at a price equal to $0.01 per warrant. During the first quarter of 2019, warrants for 400,281 shares were exercised.

 

In addition, the underwriter’s representatives for the IPO received four-year warrants to purchase up to 138,000 units, consisting of one share of common stock and one warrant to purchase one share of common stock. The warrants for the units are exercisable between June 2, 2017 and June 2, 2021 at an exercise price of $6.75 per unit.

 

The following table summarizes the Company’s warrant activity:

 

   Common Unit Warrants 
   Number of
Warrants
   Weighted
Average
Exercise
Price
   Weighted
Average
Remaining
Contractual
Term (In Years)
 
Outstanding – December 31, 2018   2,438,000   $6.75    0.55 
Granted            
Exercised   (400,281)   6.75     
Expired            
Outstanding – March 31, 2019   2,037,719   $6.75    0.32 
Exercisable – March 31, 2019   2,037,719   $6.75    0.32 

 

The intrinsic value of the common stock warrants was approximately $550,000 and $1,609,000 as of March 31, 2019, and December 31, 2018, respectively.

 

2016 and 2017 Equity Incentive Plans

 

The Company has limited the aggregate number of shares of common stock to be awarded under the 2016 Equity Incentive Plan to 397,473 shares and no more than 397,473 shares of common stock in the aggregate may be granted in connection with incentive stock options. The Company has limited the aggregate number of shares of common stock to be awarded under the 2017 Equity Incentive Plan to 500,000 shares and no more than 500,000 shares of common stock in the aggregate may be granted in connection with incentive stock options. In addition, unless the Compensation Committee specifically determines otherwise, the maximum number of shares available under the 2016 and 2017 Plans and the awards granted under those plans will be subject to appropriate adjustment in the case of any stock dividends, stock splits, recapitalizations, reorganizations, mergers, consolidations, exchanges or other changes in capitalization affecting our common stock.

 

On June 2, 2016, 307,666 shares of restricted stock were issued to employees and were recorded at the fair value of $5.25 as per the initial offering price. In addition, on January 20, 2017, 10,000 shares of restricted stock were issued to one employee and were recorded at the fair value of $4.99 per share and on October 1, 2018, 30,000 shares of restricted stock were issued to employees and were recorded at the fair value of $8.58 per share. The restricted shares vest 25% per year over a four-year vesting period and are being recognized as expense on a straight-line basis over the vesting period of the awards.

 

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On January 25, 2018, 80,000 fully vested shares were granted to the nonemployee directors, and 229,334 stock options with a four-year vesting period were granted to certain employees. The shares were recorded at the fair value of $5.55 per share for a total of $444,000 and the stock options were valued using a Black Scholes model at $3.52 per option using the assumptions noted in the following table:

 

     
Expected volatility   67.8%
Risk-free interest rate   2.5%
Expected life   6.25 years 
Dividend yield   0.0%

 

Expected Volatility. Expected volatility is a measure of the amount by which the Company’s stock price is expected to fluctuate. Expected volatility is based on the historical daily volatility of the price of our common shares. The Company estimated the expected volatility of the stock options at grant date.

 

Risk-Free Interest Rate. The risk-free interest rate is based on the implied yield on U.S. Treasury zero-coupon issues with remaining terms equivalent to the expected term of our stock-based awards.

 

Expected Term or Life. The expected term or life of stock options granted issued represents the expected weighted average period of time from the date of grant to the estimated date that the stock option would be fully exercised. The weighted average expected option term was determined using the “simplified method” for plain vanilla options as allowed by the accounting guidance. The “simplified method” calculates the expected term as the average of the vesting term and original contractual term of the options.

 

The stock options had an intrinsic value of approximately $337,000 and $427,000 as of March 31, 2019 and December 31, 2018, respectively.

 

The Company recognizes forfeitures as they occur rather than estimating a forfeiture rate. The reduction of stock compensation expense related to the forfeitures was approximately $0 and $39,000 for the three months ended March 31, 2019 and 2018, respectively.

 

Unrecognized stock compensation expense was approximately $1,233,000 as of March 31, 2019, which will be recognized over the remaining vesting period.

 

A summary of the restricted stock activity is presented as follows:

 

   Shares   Weighted 
Average
Grant Date Fair
Value
 
Unvested balance at December 31, 2018   165,834   $5.84 
Granted        
Vested   (2,500)   4.99 
Forfeited        
Unvested balance at March 31, 2019   163,334   $5.85 

 

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The following table summarizes the Company’s stock option activity:

 

   Number of
Options
   Weighted
Average
Exercise
Price
   Weighted
Average
Remaining
Contractual
Term 
(In Years)
 
Outstanding – December 31, 2018   229,334   $5.55    9.08 
Granted            
Exercised            
Expired            
Outstanding – March 31, 2019   229,334   $5.55    8.83 
Exercisable – March 31, 2019   57,334   $5.55    8.83 

 

Treasury Stock

 

The Company accounts for purchases of treasury stock under the cost method with the cost of such share purchases reflected in treasury stock in the accompanying condensed balance sheet. As of March 31, 2019 and December 31, 2018, the Company had 33,454 treasury shares.

 

Note 10 — Income Taxes

 

Book income before taxes was negative for the three months ended March 31, 2019. Tax expense for the three months ended March 31, 2019 and 2018 was $0.

 

There are no uncertain tax positions that would require recognition in the financial statements. If the Company incurs an income tax liability in the future, interest on any income tax liability would be reported as interest expense and penalties on any income tax liability would be reported as income taxes. The Company’s conclusions regarding uncertain tax positions may be subject to review and adjustment at a later date based upon ongoing analyses of tax laws, regulations and interpretations thereof as well as other factors.

 

The Company accounts for income taxes in accordance with ASC 740, Income Taxes, which prescribes a recognition threshold and measurement process for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. ASC 740 also provides guidance on de-recognition, classification, interest and penalties, accounting in interim period, disclosure and transition.

 

As of March 31, 2019, the Company has U.S. federal and certain state tax returns subject to examination, beginning with those filed for the year 2015.

 

Note 11 — Subsequent Events

 

The Company evaluates subsequent events and transactions that occur after the balance sheet date up to the date that the financial statements were issued for potential recognition or disclosure. The Company did not identify any subsequent events that would have required adjustment or disclosure in the financial statements.

 

Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

You should read the following discussion and analysis in conjunction with the information set forth within the financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q, and with our Management’s Discussion and Analysis of Financial Condition and Results of Operations in our Annual Report on Form 10-K for the year ended December 31, 2018 (“Annual Report”). The statements in this discussion regarding our expectations of our future performance, liquidity and capital resources, our plans, estimates, beliefs and expectations that involve risks and uncertainties, and other non-historical statements in this discussion, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The words “may,” “could,” “should,” “would,” “believe,” “anticipate,” “estimate,” “expect,” “intend,” “plan,” “target,” “goal,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to numerous risks and uncertainties, including, but not limited to, the risks and uncertainties described under “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q. Our actual results may differ materially from those contained in or implied by any forward-looking statements. Please see the Introductory Note and Item 1A. Risk Factors of our Annual Report, as updated in our subsequent quarterly reports filed on Form 10-Q, and in our other filings made from time to time with the SEC after the date of this report.

 

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Overview

 

We are a medical device company that is committed to providing highly effective, non-invasive and cost-effective treatments for both oncological and non-oncological skin conditions. We use a proprietary low-energy X-ray technology known as superficial radiation therapy (“SRT”), which is a result of over a decade of dedicated research and development. We have successfully incorporated SRT into our portfolio of treatment devices: the SRT-100TM, SRT-100+TM and SRT-100 VisionTM. In February 2019, we received FDA clearance of our Sculptura™, a robotic radiation oncology system that provides targeted intraoperative triple-modulated radiotherapy (IORT) and Brachytherapy utilizing our proprietary, state-of-the-art 3D Beam Sculpting™ to treat patients undergoing cancer treatment during surgery, or at the tumor site, with a single dose.

 

Components of our results of operations

 

We manage our business globally within one reportable segment, which is consistent with how our management reviews our business, prioritizes investment and resource allocation decisions and assesses operating performance.

 

Results of Operations

 

   For the Three Months Ended 
March 31,
 
   2019   2018 
         
Revenues  $5,436,599   $5,955,462 
Cost of Sales   2,120,621    2,015,200 
Gross Profit   3,315,978    3,940,262 
Operating Expenses          
Selling and marketing   2,530,346    2,214,911 
General and administrative   1,013,162    1,342,253 
Research and development   1,965,507    1,497,618 
Total Operating Expenses   5,509,015    5,054,782 
Loss From Operations   (2,193,037)   (1,114,520)
Other Income (Expense)          
Interest income   72,020    22,022 
Interest expense       (33,415)
Other Income (Expense), net   72,020    (11,393)
Net Loss  $(2,121,018)  $(1,125,913)

 

Three months ended March 31, 2019 compared to the three months ended March 31, 2018

 

Revenue. Revenue was $5,436,599 for the three months ended March 31, 2019 compared to $5,955,462 for the three months ended March 31, 2018, a decrease of $518,863, or 8.7%. The decline in revenue was primarily attributable to a decrease in sales of the higher priced SRT-100 Vision product in the current quarter.

 

Cost of sales. Cost of sales was $2,120,621 for the three months ended March 31, 2019 compared to $2,015,200 for the three months ended March 31, 2018, an increase of $105,421, or 5.2%. The increase in cost was due to changes in the mix of products sold.

 

Gross profit. Gross profit was $3,315,978 for the three months ended March 31, 2019 compared to $3,940,262 for the three months ended March 31, 2018, a decrease of $624,284, or 15.8%. Our overall gross profit percentage was 61.0% in the three months ended March 31, 2019 compared to 66.2% in the corresponding period in 2018. The decrease in gross margin percentage was primarily due to changes in the mix of products sold.

 

Selling and marketing. Selling and marketing expense was $2,530,346 for the three months ended March 31, 2019 compared to $2,214,911 for the three months ended March 31, 2018, an increase of $315,435, or 14.2%. The increase was primarily attributable to an increase in headcount.

 

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General and administrative. General and administrative expense was $1,013,162 for the three months ended March 31, 2019 compared to $1,342,253 for the three months ended March 31, 2018, a decrease of $329,091, or 24.5%. The net decrease in general and administrative was primarily due to stock compensation expense for shares granted in the first quarter of 2018, partially offset by other increases.

 

Research and development. Research and development expense was $1,965,507 for the three months ended March 31, 2019 compared to $1,497,618 for the three months ended March 31, 2018, an increase of $467,889, or 31.2%. The increase in research and development spending was primarily attributable to the FDA clearance of SculpturaTM as well as ramp to production.

 

Other income (expense). We incur interest expense in connection with our secured credit facility with Silicon Valley Bank and interest income from our cash and investments. Interest expense decreased in 2019 with the decrease in borrowings on the line of credit.

 

Financial Condition

 

Our cash, cash equivalent and investment balance decreased from $15.4 million at December 31, 2018 to $11.0 million at March 31, 2019, primarily as a result of an operating loss of $2.1 million during the three months ended in March 31, 2019 as well as the $3.7 million increase in accounts receivable as a result of higher sales and longer payment terms to certain customers.

 

There were no borrowings under the revolving line of credit at March 31, 2019 or December 31, 2018.

 

Liquidity and Capital Resources

 

Overview

 

Our liquidity position and capital requirements may be impacted by a number of factors, including the following:

 

  our ability to generate and increase revenue;
  fluctuations in gross margins, operating expenses and net results; and
  fluctuations in working capital.

 

Our primary short-term capital needs, which are subject to change, include expenditures related to:

 

  expansion of our sales, marketing and distribution activities; and
  expansion of our research and development activities.

 

We regularly evaluate our cash requirements for current operations, commitments, capital requirements and business development transactions, and we may elect to raise additional funds for these purposes in the future.

 

Cash flows

 

The following table provides a summary of our cash flows for the periods indicated:

 

   For the Three Months Ended March 31, 
   (unaudited) 
   2019   2018 
Net Cash Provided by (Used In):          
Operating Activities  $(7,117,101)  $(3,477,560)
Investing Activities   (1,817,168)   817,041 
Financing Activities   2,701,897    2,091,530 
Total  $(6,232,372)  $(568,989)

 

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Cash flows from operating activities

 

Net cash used in operating activities was $7,117,101 for the three months ended March 31, 2019, consisting of a net loss of $2,121,018 and an increase in net operating assets of $5,338,691, partially offset by non-cash charges of $342,608. The increase in net operating assets was primarily due to the increase in accounts receivable from longer payment terms to a key customer, and the increase in prepaid and other current assets, offset by a decrease in accounts payables and accrued expenses. Non-cash charges consisted of stock compensation expense, depreciation and amortizations and warranty provision. Net cash used in operating activities was $3,477,560 for the three months ended March 31, 2018, primarily due to the operating loss and the increase in accounts receivable.

 

Cash flows from investing activities

 

Net cash used by investing activities was $1,817,168 mostly due to net investments in debt securities held-to-maturity for $1,807,764 during the three months ended March 31, 2019. Net cash provided by investing activities was $817,041 for the three months ended March 31, 2018 due to the maturity of debt securities held-to-maturity of $1,104,635, offset by $287,594 for acquisition of property and equipment.

 

Cash flows from financing activities

 

Net cash provided by financing activities was $2,701,897 during the three months ended March 31, 2019 from the exercise of 400,281 investor warrants. Net cash provided by financing activities was $2,091,530 during the three months ended March 31, 2018, mainly from $2,000,663 in borrowing from our revolving credit facility.

 

Capital resources

 

On November 6, 2017, we filed a universal shelf registration statement to offer up to $20 million of our securities. In September 2018, we issued and sold 2,536,764 shares of our common stock in a follow-on public offering at a price of $6.80 per share, for an aggregate offering price of $17.25 million. We were previously limited in the amount of securities we were able to offer under a shelf registration statement pursuant to the SEC’s “baby shelf” rules. These rules previously restricted our issuance of securities under a shelf registration statement to one-third of our public float within a 12-month period. Because our public float exceeded $75 million within 60 days prior to the filing of our 2018 annual report on Form 10-K, we are not presently subject to this limitation with regard to our existing shelf registration statement. However, we must re-determine the applicability of the limitation at the time of filing another shelf registration statement and at the time of filing an annual report on Form 10-K (with respect to any shelf registration on file with the SEC at the time of filing). Depending on our public float in the future, we may become subject to this limitation again.

 

Indebtedness

 

Please see Note 4 to the financial statements.

 

Off-Balance Sheet Arrangements

 

We did not have during the periods presented, and do not currently have, any off-balance sheet arrangements.

 

Critical Accounting Policies and Estimates

 

Our discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with generally accepted accounting principles in the U.S., or GAAP. We have identified certain accounting policies as critical to understanding our financial condition and results of our operations. For a detailed discussion on the application of these and other accounting policies, see the notes to our financial statements and our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, for the year ended December 31, 2018.

 

21

 

 

JOBS Act

 

We qualify as an “emerging growth company” pursuant to the provisions of the JOBS Act. For as long as we are an “emerging growth company,” we may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not “emerging growth companies,” including, but not limited to, not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, reduced disclosure obligations relating to the presentation of financial statements in Management’s Discussion and Analysis of Financial Condition and Results of Operations, exemptions from the requirements of holding advisory “say-on-pay” votes on executive compensation and shareholder advisory votes on golden parachute compensation. We have availed ourselves of the reduced reporting obligations in this Quarterly Report on Form 10-Q, and expect to continue to avail ourselves of the reduced reporting obligations available to emerging growth companies in future filings.

 

In addition, an emerging growth company can delay its adoption of certain accounting standards until those standards would otherwise apply to private companies. However, we have chosen to “opt out” of such extended transition period, and as a result, we plan to comply with any new or revised accounting standards on the relevant dates on which non-emerging growth companies must adopt such standards. Section 107 of the JOBS Act provides that our decision to opt out of the extended transition period for complying with new or revised accounting standards is irrevocable.

 

Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Not applicable.

 

Item 4. CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Control and Procedures

 

As of March 31, 2019, the end of the period covered by this Form 10-Q, our management, including our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934). Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer each concluded that, as of March 31, 2019, the end of the period covered by this Form 10-Q, we maintained effective disclosure controls and procedures.

 

Changes in Internal Control over Financial Reporting

 

There have been no significant changes in our internal control over financial reporting during our most recently completed fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

PART II. OTHER INFORMATION

 

Item 1. Legal Proceedings

 

The Company is party to certain legal proceedings in the ordinary course of business. The Company assesses, in conjunction with its legal counsel, the need to record a liability for litigation and related contingencies. See Note 7, Commitments and Contingencies.

 

Item 1A. Risk Factors

 

An investment in our securities involves risks. You should carefully consider the risk factors as previously disclosed in our Form 10-K filed with the SEC for the year ended December 31, 2018, as updated in our subsequent quarterly reports, together with the other information in this Quarterly Report on Form 10-Q, including the financial statements and related notes, before deciding whether to purchase, hold, or sell our securities. The occurrence of any of these risks could harm our business, financial condition, or results of operations or cause our actual results to differ materially from those contained in forward-looking statements we have made in this report and those we may make from time to time. You should consider all of the risk factors described when evaluating our business. There have been no material changes to the risk factors as previously disclosed in our Form 10-K filed with the SEC for the year ended December 31, 2018, the discussion of which is specifically incorporated by reference into this Quarterly Report on Form 10-Q.

 

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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

(a) Sales of Unregistered Securities

 

There were no unregistered sales of securities during the three months ended March 31, 2019.

 

(b) Use of Proceeds from the Sale of Registered Securities

 

None.

 

(c) Purchases of Equity Securities by the Registrant and Affiliated Purchases.

 

None.

 

Item 3. Defaults Upon Senior Securities

 

None.

 

Item 4. Mine Safety Disclosure

 

Not applicable.

 

Item 5. Other Information

 

None.

 

Item 6. Exhibits

 

Exhibit No. Description
   
31.1 Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934.
   
31.2 Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934.
   
32.1 Certification of Joseph C. Sardano, Chairman and Chief Executive Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.
   
32.2 Certification of Arthur Levine, Chief Financial Officer of Sensus Healthcare, Inc., Pursuant to 18 U.S.C. Section 1350.

 

101.INS XBRL Instance Document
   
101.SCH XBRL Taxonomy Extension Schema Document
   
101.CAL XBRL Taxonomy Extension Calculation Linkbase Document
   
101.LAB XBRL Taxonomy Extension Label Linkbase Document
   
101.PRE XBRL Taxonomy Extension Presentation Linkbase Document
   
101.DEF XBRL Taxonomy Extension Definition Linkbase Document

 

23

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

  SENSUS HEALTHCARE, INC.
   
Date: May 14, 2019 /s/ Joseph C. Sardano
  Joseph C. Sardano
  Chief Executive Officer
  (Principal Executive Officer)
   
Date: May 14, 2019 /s/ Arthur Levine
  Arthur Levine
  Chief Financial Officer
  (Principal Financial Officer and Principal Accounting Officer)

 

24

 

Exhibit 31.1

 

Certification of CEO Pursuant to Securities Exchange Act

 

Rule 13a-14(a)/15d-14(a) as Adopted Pursuant to

 

Section 302 of the Sarbanes-Oxley Act of 2002

 

I, Joseph C. Sardano, certify that:

 

1.I have reviewed this quarterly report on Form 10-Q of Sensus Healthcare, Inc.;

 

2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:

 

aDesigned such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b.Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 14, 2019 /s/ Joseph C. Sardano
  Joseph C. Sardano
  Chairman and Chief Executive Officer

 

25

 

Exhibit 31.2

 

Certification of CFO Pursuant to Securities Exchange Act

 

Rule 13a-14(a)/15d-14(a) as Adopted Pursuant to

 

Section 302 of the Sarbanes-Oxley Act of 2002

 

I, Arthur Levine, certify that:

 

1.I have reviewed this quarterly report on Form 10-Q of Sensus Healthcare, Inc.;

 

2.Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have:

 

aDesigned such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

b.Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

c.Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

d.Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

a.All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

b.Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 14, 2019

/s/ Arthur Levine
  Arthur Levine
  Chief Financial Officer

 

26

 

Exhibit 32.1

 

Certification of CEO Pursuant to 18 U.S.C. Section 1350

 

Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned certificates that:

 

(1) this Quarterly Report for Sensus Healthcare, Inc. (the “Company”) on Form 10-Q for the period ended March 31, 2019, as filed with the Securities and Exchange Commission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and

 

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for the periods covered therein.

 

A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature that appears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

 

/s/ Joseph C. Sardano  
Joseph C. Sardano  
Chairman and Chief Executive Officer  
   
May 14, 2019  

 

27

 

Exhibit 32.2

 

Certification of CFO Pursuant to 18 U.S.C. Section 1350

 

Pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, the undersigned certificates that:

 

(1) this Quarterly Report for Sensus Healthcare, Inc. (the “Company”) on Form 10-Q for the period ended March 31, 2019, as filed with the Securities and Exchange Commission on the date hereof (this “Report”), fully complies with the requirements of Section 13(a) of the Securities Exchange Act of 1934, as amended; and

 

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for the periods covered therein.

 

A signed original of this written statement required by Section 906, or other document authenticating, acknowledging or otherwise adopting the signature that appears in typed form within the electronic version of this written statement, has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

 

/s/ Arthur Levine  
Arthur Levine  
Chief Financial Officer  
   
May 14, 2019  

 

28

v3.19.1
Document and Entity Information - shares
3 Months Ended
Mar. 31, 2019
Apr. 30, 2019
Document And Entity Information    
Entity Registrant Name Sensus Healthcare, Inc.  
Entity Central Index Key 0001494891  
Document Type 10-Q  
Trading Symbol SRTS  
Document Period End Date Mar. 31, 2019  
Amendment Flag false  
Current Fiscal Year End Date --12-31  
Entity's Reporting Status Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company true  
Entity Ex Transition Period true  
Entity Common Stock, Shares Outstanding   16,518,242
Document Fiscal Period Focus Q1  
Document Fiscal Year Focus 2019  
v3.19.1
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($)
Mar. 31, 2019
Dec. 31, 2018
Current Assets    
Cash and cash equivalents $ 6,251,884 $ 12,484,256
Accounts receivable, net 16,881,672 13,145,934
Inventories 1,551,419 1,628,817
Investment in debt securities 4,699,954 2,892,190
Prepaid and other current assets 2,252,755 1,750,994
Total Current Assets 31,637,684 31,902,191
Property and Equipment, Net 899,792 891,029
Patent Rights, Net 409,640 433,737
Deposits 24,272 24,272
Operating Lease Right-of-Use Assets, Net 749,114 0
Total Assets 33,720,502 33,251,229
Current Liabilities    
Accounts payable and accrued expenses 4,075,214 5,166,239
Deferred revenue, current portion 744,996 722,025
Operating lease liabilities, current portion 240,972
Product warranties 137,942 136,217
Total Current Liabilities 5,199,124 6,024,481
Operating Lease Liabilities 510,784
Deferred Revenue, Net of Current Portion 815,164 766,732
Total Liabilities 6,525,072 6,791,213
Stockholders' Equity    
Preferred stock, 5,000,000 shares authorized and none issued and outstanding
Common stock, $0.01 par value - 50,000,000 authorized; 16,546,196 issued and 16,512,742 outstanding at March 31, 2019; 16,145,915 issued and 16,112,461 outstanding at December 31, 2018 165,461 161,459
Additional paid-in capital 42,810,335 39,957,905
Treasury stock, 33,454 shares at cost, at March 31, 2019 and December 31, 2018, respectively (133,816) (133,816)
Accumulated deficit (15,646,550) (13,525,532)
Total Stockholders' Equity 27,195,430 26,460,016
Total Liabilities and Stockholders' Equity $ 33,720,502 $ 33,251,229
v3.19.1
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares
Mar. 31, 2019
Dec. 31, 2018
Statement of Financial Position [Abstract]    
Preferred stock, authorized 5,000,000 5,000,000
Preferred stock, issued 0 0
Preferred stock, outstanding 0 0
Common stock, par value (in dollars per share) $ 0.01 $ 0.01
Common stock, authorized 50,000,000 50,000,000
Common stock, issued 16,546,196 16,512,742
Common Stock, outstanding 16,145,915 16,112,461
Treasury stock, shares 33,454 33,454
v3.19.1
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($)
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Income Statement [Abstract]    
Revenues $ 5,436,599 $ 5,955,462
Cost of Sales 2,120,621 2,015,200
Gross Profit 3,315,978 3,940,262
Operating Expenses    
Selling and marketing 2,530,346 2,214,911
General and administrative 1,013,162 1,342,253
Research and development 1,965,507 1,497,618
Total Operating Expenses 5,509,015 5,054,782
Loss From Operations (2,193,037) (1,114,520)
Other Income (Expense)    
Interest income 72,020 22,022
Interest expense (33,415)
Other Income (Expense), net 72,020 (11,393)
Net Loss $ (2,121,018) $ (1,125,913)
Net Loss per share - basic and diluted (in dollars per share) $ (0.13) $ (0.08)
Weighted average number of shares used in computing net loss per share - basic and diluted (in shares) 16,119,726 13,331,553
v3.19.1
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited) - USD ($)
Common Stock
Additional Paid-In Capital
Treasury Stock
Accumulated Deficit
Total
Balance beginning at Dec. 31, 2017 $ 135,221 $ (33,454) $ (133,816) $ (11,502,771) $ 11,680,275
Balance beginning (in shares) at Dec. 31, 2017 13,522,168 23,181,641      
Stock based compensation $ 500 541,608
Exercise of warrants 293 90,867
Net loss (1,125,913) (1,125,913)
Balance end at Mar. 31, 2018 $ 136,014 $ (33,454) (133,816) (12,628,684) 11,186,837
Balance end (in shares) at Mar. 31, 2018 13,601,456 23,813,323      
Balance beginning at Dec. 31, 2018 $ 161,459 $ (33,454) (133,816) (13,525,532) 26,460,016
Balance beginning (in shares) at Dec. 31, 2018 16,145,915 39,957,905      
Stock based compensation 154,535
Stock based compensation (in shares) 154,535      
Exercise of warrants $ 4,002 2,701,897
Net loss (2,121,018) (2,121,018)
Balance end at Mar. 31, 2019 $ 165,461 $ (33,454) $ (133,816) $ (15,646,550) $ 27,195,430
Balance end (in shares) at Mar. 31, 2019 16,546,196 42,810,335      
v3.19.1
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($)
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Cash Flows From Operating Activities    
Net loss $ (2,121,018) $ (1,125,913)
Adjustments to reconcile net loss to net cash and cash equivalents used in operating activities:    
Bad debt expense (recovery) 2,345
Depreciation and amortization 128,435 100,534
Provision for product warranties 59,638 36,790
Stock based compensation 154,535 541,608
Decrease (increase) in:    
Accounts receivable (3,735,738) (3,107,036)
Inventories (26,299) (62,071)
Prepaid and other current assets (445,874) 86,775
Increase (decrease) in:    
Accounts payable and accrued expenses (1,144,269) 87,870
Deferred revenue 71,402 5,005
Product warranties (57,913) (43,467)
Total Adjustments (4,996,083) (2,351,647)
Net Cash Used In Operating Activities (7,117,101) (3,477,560)
Cash Flows from Investing Activities    
Acquisition of property and equipment (9,404) (287,594)
Investment in debt securities - held to maturity (3,007,764)
Investments matured 1,200,000 1,104,635
Net Cash Provided By (Used In) Investing Activities (1,817,168) 817,041
Cash Flows from Financing Activities    
Revolving credit facility, net 2,000,663
Exercise of warrants 2,701,897 90,867
Net Cash Provided By Financing Activities 2,701,897 2,091,530
Net Decrease in Cash and Cash Equivalents (6,232,372) (568,991)
Cash and Cash Equivalents - Beginning 12,484,256 10,085,468
Cash and Cash Equivalents - Ending 6,251,884 9,516,479
Supplemental Disclosure of Cash Flow Information    
Interest Paid 33,415
Non Cash Investing and Financing Activities    
Transfer of inventory to property and equipment 103,697
Lease liabilities arising from obtaining right-of-use-assets $ 805,000
v3.19.1
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
3 Months Ended
Mar. 31, 2019
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Note 1 — Organization and Summary of Significant Accounting Policies

 

Description of the Business

 

Sensus Healthcare, Inc. (the “Company”) is a manufacturer of radiation therapy devices and has established a distribution and marketing network to sell the devices to healthcare providers globally. The Company was organized on May 7, 2010 as a limited liability corporation. On January 1, 2016, the Company completed a corporate conversion pursuant to which Sensus Healthcare, Inc. succeeded to the business of Sensus Healthcare, LLC. In February 2018, the Company opened a subsidiary in Israel. The Company operates as one segment from its corporate headquarters located in Boca Raton, Florida.

 

Basis of Presentation

 

The accompanying unaudited condensed financial statements in this Quarterly Report on Form 10-Q have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, and the rules and regulations of the U.S. Securities and Exchange Commission, or SEC. Accordingly, they do not include certain footnotes and financial presentations normally required under accounting principles generally accepted in the United States of America for complete financial statements. The interim financial information is unaudited, but reflects all normal adjustments and accruals which are, in the opinion of management, considered necessary to provide a fair presentation for the interim periods presented. The accompanying condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto for the year ended December 31, 2018 included in the Company’s Form 10-K, filed with the SEC. The results for the three months ended March 31, 2019 are not necessarily indicative of results to be expected for the year ending December 31, 2019, any other interim periods, or any future year or period.

 

Principles of consolidation

 

The accompanying condensed consolidated financial statements include the financial statements of the Company and its wholly-owned subsidiary in Israel. All inter-company balances and transactions have been eliminated.

 

Use of Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates to which it is reasonably possible that a change could occur in the near term include, inventory reserves, receivable allowances, recoverability of long-lived assets and estimation of the Company’s product warranties. Actual results could differ from those estimates.

 

Revenue Recognition

 

On January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modified retrospective method for all contracts as of the date of adoption. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there were no necessary adjustments required to retained earnings upon adoption.

 

Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to a customer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services, which is generally upon shipment of the goods and performance of the service. The amount of revenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, a contract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performance obligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performance obligation.

 

The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of the devices and the service contract are usually signed at the same time and in some instances a service contract is signed on a stand-alone basis. Revenue for service contracts is recognized over the service contract period on a straight-line basis. The Company determined that in practice no significant discount is given on the service contract when it is offered with the device purchase as compared to when it is sold on a stand-alone basis, by comparing the median selling price of the service contract as stand-alone and the median selling price of the service contract when sold together with the device. The service level provided is identical when the service contract is purchased stand-alone or together with the device. There is no termination provision in the service contract nor any penalties in practice for cancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for a significant discount when purchased with the device. The service portion of a sales contract or a stand-alone service contract is accounted for over the period of time of the service contract only when the customer exercises the option by paying for the service contract.

 

Disaggregated revenue for the three months ended March 31, 2019 and 2018 was as follows:

 

    For the Three Months Ended 
March 31,
 
    2019     2018  
Product Revenue   $ 4,930,924     $ 5,532,647  
Service Revenue     505,675       422,815  
Total Revenue   $ 5,436,599     $ 5,955,462  

 

The Company operates in a highly regulated environment in which state regulatory approval is sometimes required prior to the customer being able to use the product, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval is obtained.

 

Deferred revenue as of March 31, 2019 was as follows:

 

    Service     Product     Total Deferred Revenue  
Balance, beginning of period   $ 1,455,757     $ 33,000     $ 1,488,757  
Revenue recognized     (368,956 )     (33,000 )     (401,956 )
Amounts invoiced     473,359             473,359  
Balance, end of period   $ 1,560,160     $     $ 1,560,160  

 

The Company does not disclose information about remaining performance obligations of deposits for products that have original expected durations of one year or less. Estimated service revenue to be recognized in the future related to the performance obligations that are unsatisfied (or partially unsatisfied) as of March 31, 2019 is as follows:

 

Year   Service Revenue  
2019 (April 1 – December 31, 2019)   $ 579,785  
2020     539,914  
2021     405,892  
2022     34,569  
Total   $ 1,560,160  

 

 

The Company provides warranties in conjunction with the sale of its products. These warranties entitle the customer to repair, replacement, or modification of the defective product subject to the terms of the respective warranty. The Company records an estimate of future warranty claims at the time the Company recognizes revenue from the sale of the product based upon management’s estimate of the future claims rate.

 

Shipping and handling costs are expensed as incurred and are included in cost of sales.

 

Segment and Geographical Information

 

The Company’s revenue is generated primarily from customers in the United States, which represented approximately 81% and 100% for the three months ended March 31, 2019 and 2018, respectively. A single customer in the US accounted for approximately 53% and 75% of revenues for the three months ended March 31, 2019 and 2018, respectively, and approximately 87% of the accounts receivable as of March 31, 2019 and December 31, 2018, respectively.

 

Cash and Cash Equivalents

 

The Company maintains its cash and cash equivalents with financial institutions which balances exceed the federally insured limits. Federally insured limits are $250,000 for deposits. As of March 31, 2019 and December 31, 2018, the Company had approximately $5,679,000 and $11,726,000, respectively in excess of federally insured limits.

 

For purposes of the statement of cash flows, the Company considers all highly liquid financial instruments with a maturity of three months or less when purchased to be a cash equivalent.

 

Investments

 

Short-term investments consist of investments which the Company expects to convert into cash within one year and long-term investments after one year. The Company classifies its investments in debt securities at the time of purchase as held-to-maturity and reevaluates such classification on a quarterly basis. Held-to-maturity investments consist of securities that the Company has the intent and ability to retain until maturity. These securities are carried at amortized cost plus accrued interest and consist of the following:

 

    Amortized
Cost
    Gross
Unrealized
Gain
    Gross
Unrealized
Loss
    Fair
Value
 
Short-Term:                                
Corporate bonds   $ 2,892,190     $     $ 623     $ 2,891,567  
Total Short Term:     2,892,190             623       2,891,567  
                                 
Total Investments December 31, 2018   $ 2,892,190     $     $ 623     $ 2,891,567  
                                 
Short-Term:                                
Corporate bonds   $ 4,699,954     $ 1,226     $     $ 4,701,180  
Total Short Term:     4,699,954       1,226             4,701,180  
                                 
Total Investments March 31, 2019   $ 4,699,954     $ 1,226     $     $ 4,701,180  

 

Accounts Receivable

 

The Company does business and extends credit based on an evaluation of each customer’s financial condition, generally without requiring collateral. Exposure to losses on receivables is expected to vary by customer due to the financial condition of each customer. The Company monitors exposure to credit losses and maintains allowances for anticipated losses considered necessary under the circumstances. The allowance for doubtful accounts was $0 as of March 31, 2019 and December 31, 2018. Bad debt expense for the three months ended March 31, 2019 and 2018 was approximately $0 and $2,000, respectively.

 

Inventories

 

Inventories consist of finished product and components and are stated at the lower of cost or net realizable value, determined using the first-in-first-out method.

 

Earnings Per Share

 

Basic net income (loss) per share is calculated by dividing the net income (loss) by the weighted-average number of common shares outstanding for the period. The diluted net income per share is computed by giving effect to all potential dilutive common share equivalents outstanding for the period, using the treasury stock method for options and warrants, as well as unvested restricted shares. In periods when the Company has incurred a net loss, options, warrants and unvested shares are considered common share equivalents but have been excluded from the calculation of diluted net loss per share as their effect is antidilutive. Shares were excluded as follows:

 

    For the Three Months Ended 
March 31,
 
    2019     2018  
Warrants     256,035        
Stock options     64,463       3,660  
Shares     70,951        

 

Advertising Costs

 

Advertising and promotion expenses are charged to expense as incurred. Advertising and promotion expense included in selling expense in the accompanying statements of operations amounted to approximately $539,000 and $522,000 for the three months ended March 31, 2019 and 2018, respectively.

 

Leases

 

The Company evaluates arrangements at inception to determine if an arrangement is or contains a lease. Operating lease assets represent the Company’s right to use an underlying asset for the lease term and operating lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease assets and liabilities are recognized at the commencement date of the lease based upon the present value of lease payments over the lease term. When determining the lease term, the Company includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. The Company uses an incremental borrowing rate that the Company would expect to incur for a fully collateralized loan over a similar term under similar economic conditions to determine the present value of the lease payments.

 

The lease payments used to determine the Company’s operating lease assets may include lease incentives and stated rent increases and are recognized in the Company’s operating lease assets in the Company’s condensed consolidated balance sheets. Operating lease assets are amortized to rent expense over the lease term and included in operating expenses in the condensed consolidated statements of operations.

 

Recently issued and Adopted accounting Standards

 

In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842).” The guidance in ASU 2016-02 supersedes the lease recognition requirements in ASC Topic 840, Leases (FAS 13). The new standard establishes a right-of-use (“ROU”) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The new standard is effective for fiscal years beginning after December 1, 2018, including interim periods within those fiscal years, with early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. Early adoption of the amendments in the update is permitted. The Company adopted this standard in the first quarter of 2019 using the modified retrospective approach. The adoption of this standard resulted in the recognition of operating lease right-of-use assets and associated lease liabilities on our balance sheet of approximately $805,000 and $805,000, respectively, as of January 1, 2019. Additional required disclosures have been included within Note 6 - Leases. Such adoption did not have a material impact on our liquidity, results of operations or our compliance with the revolving credit facility covenants.

v3.19.1
PROPERTY AND EQUIPMENT
3 Months Ended
Mar. 31, 2019
Property, Plant and Equipment [Abstract]  
PROPERTY AND EQUIPMENT

Note 2 — Property and Equipment

 

    As of March 31, 2019     As of December 31, 2018     Estimated Useful Lives  
    (unaudited)                
Operations equipment   $ 854,302     $ 852,273     3 years  
Tradeshow and demo equipment     890,929       784,244     3 years  
Computer equipment     117,666       112,521     3 years  
      1,862,897       1,749,038        
Less accumulated depreciation     (963,105 )     (858,009 )      
Property and Equipment, Net   $ 899,792     $ 891,029        

 

Depreciation expense was approximately $104,000 and $76,000, for the three months ended March 31, 2019 and 2018, respectively.

v3.19.1
PATENT RIGHTS
3 Months Ended
Mar. 31, 2019
Goodwill and Intangible Assets Disclosure [Abstract]  
PATENT RIGHTS

Note 3 — Patent Rights 

 

    As of March 31,     As of December 31,  
    2019     2018  
    (unaudited)          
Gross carrying amount   $ 1,253,018     $ 1,253,018  
Less accumulated amortization     (843,378 )     (819,281 )
Patent Rights, Net   $ 409,640     $ 433,737  

 

Amortization expense was approximately $24,000 for the three months ended March 31, 2019 and 2018. As of March 31, 2019, future remaining amortization expense is as follows:

 

Year      
2019 (April 1 – December 31, 2019)   $ 72,290  
2020     96,386  
2021     96,386  
2022     96,386  
2023     48,192  
Total   $ 409,640  
v3.19.1
REVOLVING CREDIT FACILITY
3 Months Ended
Mar. 31, 2019
Debt Disclosure [Abstract]  
REVOLVING CREDIT FACILITY

Note 4 — Revolving Credit Facility

 

On October 31, 2017, the Company amended its revolving credit facility to extend the maturity to October 31, 2019 and to amend the financial covenants. The availability under the amended facility will equal the lesser of the $5 million commitment amount or the borrowing base plus the $2.5 million non-formula sublimit. The borrowing base consists of 80% of eligible accounts receivable, as defined in the agreement.

 

Interest, at Prime plus 0.75% (6.25% at March 31, 2019) and Prime plus 1.50% on non-formula borrowings (7.00% at March 31, 2019), is payable monthly, and the outstanding principal and interest are due on the maturity date. The facility is secured by all of the Company’s assets and limits the amount of additional indebtedness, restricts the sale, disposition or transfer of assets of the Company and requires the maintenance of a certain monthly adjusted quick ratio restrictive covenant, as defined in the agreement. The Company was in compliance with its financial covenants as of March 31, 2019 and December 31, 2018. There were no borrowings outstanding under the revolving credit facility at March 31, 2019 and December 31, 2018. The Company pays commitment fees of 0.25% per annum on the average unused portion of the line of credit.

v3.19.1
PRODUCT WARRANTIES
3 Months Ended
Mar. 31, 2019
Product Warranties Disclosures [Abstract]  
PRODUCT WARRANTIES

Note 5 — Product Warranties

 

Changes in product warranty liability were as follows for the nine months ended March 31, 2019:

 

Balance, beginning of period   $ 136,217  
Warranties accrued during the period     59,638  
Payments on warranty claims     (57,913 )
Balance, end of period   $ 137,942  
v3.19.1
LEASES
3 Months Ended
Mar. 31, 2019
Leases [Abstract]  
LEASES

Note 6 — Leases

 

Operating Lease Agreements

 

In July 2016, the Company renewed its lease with an unrelated third party for its headquarters office. The renewal was effective September 1, 2016 and expanded the office space being occupied. The lease expires in September 2022 and lease payments increase by 3% annually. In February 2017 and January 2018, the Company signed amendments to expand further the leased office space. The Company’s Israeli subsidiary entered into a two-year lease for office space starting in September 2018. The leases include an option to extend with prior notice and with terms to be negotiated. The Company currently does not have any lease with a term under 12 months.

 

On March 19, 2019, the Company’s Israeli subsidiary signed a 10-year lease for a manufacturing facility, effective April 1, for approximately 5,800 square feet. The landlord has provided a four-month grace period rent free from April to July 2019, after which the 10 year lease will begin. The monthly rental payment starts at approximately $5,300 and will be subject to periodic escalations at amounts specified in the lease plus the consumer price index. In addition, the Company is responsible for maintenance fees covering its portion of the expenses of common areas. After 2, 4, 6 and 8 years, and with 180 days prior notice, the Company has the right to terminate the lease at its sole discretion with no penalty.

 

The following table presents information about the amount, timing and uncertainty of cash flows arising from the Company’s operating leases as of March 31, 2019.

 

Maturity of Operating Lease Liabilities   Amount  
2019 (April 1 – December 31, 2019)   $ 187,420  
2020     245,237  
2021     230,674  
2022     176,866  
Total undiscounted operating leases payments   $ 840,197  
Less: Imputed interest     (88,441 )
Present Value of Operating Lease Liabilities   $ 751,756  
         
Other Information        
Weighted-average remaining lease term     3.3 years  
Weighted-average discount rate     5.0 %

 

An initial ROU asset of approximately $805,000 was recognized as a non-cash assets addition with the adoption of the new lease accounting standard. The ROU asset was reduced by approximately $56,000 during the three months ended March 31, 2019. Cash paid for amounts included in the present value of operating lease liabilities was approximately $62,000 for the three months ended March 31, 2019 and is included in operating cash flows. Operating lease cost was approximately $65,000 for the three months ended March 31, 2019.

v3.19.1
COMMITMENT AND CONTINGENCIES
3 Months Ended
Mar. 31, 2019
Commitments and Contingencies Disclosure [Abstract]  
COMMITMENT AND CONTINGENCIES

Note 7 — Commitments and Contingencies

 

Manufacturing Agreement

 

In July 2010, the Company entered into a three-year contract manufacturing agreement with an unrelated third party for the production and manufacture of the SRT-100, the Company’s main product in accordance with the Company’s product specifications. The agreement renews for successive one-year periods unless either party notifies the other party in writing, at least 60 days prior to the anniversary date of this agreement that it will not renew the agreement. The Company or the manufacturer has the option to terminate the agreement upon 90 days written notice. Any change in the relationship with the manufacturer could have an adverse effect on the Company’s business.

 

Purchases from this manufacturer totaled approximately $1,911,000 and $1,137,000 for the three months ended March 31, 2019 and 2018, respectively. As of March 31, 2019, and December 31, 2018 approximately $663,000 and $1,041,000, respectively, was due to this manufacturer, which is presented in accounts payable and accrued expenses in the accompanying balance sheets.

 

Legal contingencies

 

The Company is party to certain legal proceedings in the ordinary course of business. The Company assesses, in conjunction with its legal counsel, the need to record a liability for litigation and related contingencies.

 

In November 2015, the Company learned that the Department of Justice (the “Department”) had commenced an investigation of the billing to Medicare by a physician who had treated patients with the Company’s SRT-100. The Company received a Civil Investigative Demand from the Department seeking documents and written responses in connection with that investigation. The Company has fully cooperated with the investigation. The Department has advised the Company that it was considering expanding the investigation to determine whether the Company had any involvement in the physician’s use of certain reimbursement codes. The Company disputes that it has engaged in any wrongdoing with respect to such reimbursement claims; among other things, the Company does not submit claims for reimbursement or provide coding or billing advice to physicians. To the Company’s knowledge, the Department has made no determination as to whether the Company engaged in any wrongdoing, or whether to pursue any legal action against the Company. Should the Department decide to pursue legal action, the Company believes it has strong and meritorious defenses and will vigorously defend itself. At this time, the Company is unable to estimate the cost associated with this matter.

v3.19.1
EMPLOYEE BENEFIT PLANS
3 Months Ended
Mar. 31, 2019
Retirement Benefits [Abstract]  
EMPLOYEE BENEFIT PLANS

Note 8 — Employee Benefit Plans

 

We sponsor a 401(k) defined contribution retirement plan that allows eligible employees to contribute a portion of their compensation through payroll deductions in accordance with specified plan guidelines. We make contributions to the plans that include matching a percentage of the employees’ contributions up to certain limits. Expenses related to this plan totaled approximately $28,000 and $24,000 for the three months ended March 31, 2019 and 2018, respectively.

v3.19.1
STOCKHOLDERS' EQUITY
3 Months Ended
Mar. 31, 2019
Equity [Abstract]  
STOCKHOLDERS' EQUITY

Note 9 — Stockholders’ Equity

 

The Company has authorized 50,000,000 shares of common stock, of which 16,546,196 were issued and 16,512,742 outstanding at March 31, 2019; 16,145,915 shares were issued and 16,112,461 were outstanding as of December 31, 2018.

 

Warrants

 

In April 2013, the closing date of the Company’s second common offering, the Company’s placement agent received investor rights to 5 year warrants to purchase 86,376 common shares of the Company at an exercise price of $4.55 per unit, which was equal to 110% of the offering price. During the first quarter of 2018, 73,309 of the warrants were exercised, and 13,067 warrants expired.

 

In June 2016, from the Company’s IPO, the investors received three-year warrants to purchase 2,300,000 shares of common stock at an exercise price of $6.75 per share; the warrants are exercisable through June 2, 2019. Following the first anniversary of the date of issuance, if certain conditions are met, the Company may redeem any and all of the outstanding warrants at a price equal to $0.01 per warrant. During the first quarter of 2019, warrants for 400,281 shares were exercised.

 

In addition, the underwriter’s representatives for the IPO received four-year warrants to purchase up to 138,000 units, consisting of one share of common stock and one warrant to purchase one share of common stock. The warrants for the units are exercisable between June 2, 2017 and June 2, 2021 at an exercise price of $6.75 per unit.

 

The following table summarizes the Company’s warrant activity:

 

    Common Unit Warrants  
    Number of
Warrants
    Weighted
Average
Exercise
Price
    Weighted
Average
Remaining
Contractual
Term (In Years)
 
Outstanding – December 31, 2018     2,438,000     $ 6.75       0.55  
Granted                  
Exercised     (400,281 )     6.75        
Expired                  
Outstanding – March 31, 2019     2,037,719     $ 6.75       0.32  
Exercisable – March 31, 2019     2,037,719     $ 6.75       0.32  

 

The intrinsic value of the common stock warrants was approximately $550,000 and $1,609,000 as of March 31, 2019, and December 31, 2018, respectively.

 

2016 and 2017 Equity Incentive Plans

 

The Company has limited the aggregate number of shares of common stock to be awarded under the 2016 Equity Incentive Plan to 397,473 shares and no more than 397,473 shares of common stock in the aggregate may be granted in connection with incentive stock options. The Company has limited the aggregate number of shares of common stock to be awarded under the 2017 Equity Incentive Plan to 500,000 shares and no more than 500,000 shares of common stock in the aggregate may be granted in connection with incentive stock options. In addition, unless the Compensation Committee specifically determines otherwise, the maximum number of shares available under the 2016 and 2017 Plans and the awards granted under those plans will be subject to appropriate adjustment in the case of any stock dividends, stock splits, recapitalizations, reorganizations, mergers, consolidations, exchanges or other changes in capitalization affecting our common stock.

 

On June 2, 2016, 307,666 shares of restricted stock were issued to employees and were recorded at the fair value of $5.25 as per the initial offering price. In addition, on January 20, 2017, 10,000 shares of restricted stock were issued to one employee and were recorded at the fair value of $4.99 per share and on October 1, 2018, 30,000 shares of restricted stock were issued to employees and were recorded at the fair value of $8.58 per share. The restricted shares vest 25% per year over a four-year vesting period and are being recognized as expense on a straight-line basis over the vesting period of the awards.

  

On January 25, 2018, 80,000 fully vested shares were granted to the nonemployee directors, and 229,334 stock options with a four-year vesting period were granted to certain employees. The shares were recorded at the fair value of $5.55 per share for a total of $444,000 and the stock options were valued using a Black Scholes model at $3.52 per option using the assumptions noted in the following table:

 

       
Expected volatility     67.8 %
Risk-free interest rate     2.5 %
Expected life     6.25 years  
Dividend yield     0.0 %

 

Expected Volatility. Expected volatility is a measure of the amount by which the Company’s stock price is expected to fluctuate. Expected volatility is based on the historical daily volatility of the price of our common shares. The Company estimated the expected volatility of the stock options at grant date.

 

Risk-Free Interest Rate. The risk-free interest rate is based on the implied yield on U.S. Treasury zero-coupon issues with remaining terms equivalent to the expected term of our stock-based awards.

 

Expected Term or Life. The expected term or life of stock options granted issued represents the expected weighted average period of time from the date of grant to the estimated date that the stock option would be fully exercised. The weighted average expected option term was determined using the “simplified method” for plain vanilla options as allowed by the accounting guidance. The “simplified method” calculates the expected term as the average of the vesting term and original contractual term of the options.

 

The stock options had an intrinsic value of approximately $337,000 and $427,000 as of March 31, 2019 and December 31, 2018, respectively.

 

The Company recognizes forfeitures as they occur rather than estimating a forfeiture rate. The reduction of stock compensation expense related to the forfeitures was approximately $0 and $39,000 for the three months ended March 31, 2019 and 2018, respectively.

 

Unrecognized stock compensation expense was approximately $1,233,000 as of March 31, 2019, which will be recognized over the remaining vesting period.

 

A summary of the restricted stock activity is presented as follows:

 

    Shares     Weighted 
Average
Grant Date Fair
Value
 
Unvested balance at December 31, 2018     165,834     $ 5.84  
Granted            
Vested     (2,500 )     4.99  
Forfeited            
Unvested balance at March 31, 2019     163,334     $ 5.85  

 

 

The following table summarizes the Company’s stock option activity:

 

    Number of
Options
    Weighted
Average
Exercise
Price
    Weighted
Average
Remaining
Contractual
Term 
(In Years)
 
Outstanding – December 31, 2018     229,334     $ 5.55       9.08  
Granted                  
Exercised                  
Expired                  
Outstanding – March 31, 2019     229,334     $ 5.55       8.83  
Exercisable – March 31, 2019     57,334     $ 5.55       8.83  

 

Treasury Stock

 

The Company accounts for purchases of treasury stock under the cost method with the cost of such share purchases reflected in treasury stock in the accompanying condensed balance sheet. As of March 31, 2019 and December 31, 2018, the Company had 33,454 treasury shares.

v3.19.1
INCOME TAXES
3 Months Ended
Mar. 31, 2019
Income Tax Disclosure [Abstract]  
INCOME TAXES

Note 10 — Income Taxes

 

Book income before taxes was negative for the three months ended March 31, 2019. Tax expense for the three months ended March 31, 2019 and 2018 was $0.

 

There are no uncertain tax positions that would require recognition in the financial statements. If the Company incurs an income tax liability in the future, interest on any income tax liability would be reported as interest expense and penalties on any income tax liability would be reported as income taxes. The Company’s conclusions regarding uncertain tax positions may be subject to review and adjustment at a later date based upon ongoing analyses of tax laws, regulations and interpretations thereof as well as other factors.

 

The Company accounts for income taxes in accordance with ASC 740, Income Taxes, which prescribes a recognition threshold and measurement process for financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. ASC 740 also provides guidance on de-recognition, classification, interest and penalties, accounting in interim period, disclosure and transition.

 

As of March 31, 2019, the Company has U.S. federal and certain state tax returns subject to examination, beginning with those filed for the year 2015.

v3.19.1
SUBSEQUENT EVENTS
3 Months Ended
Mar. 31, 2019
Subsequent Events [Abstract]  
SUBSEQUENT EVENTS

Note 11 — Subsequent Events

 

The Company evaluates subsequent events and transactions that occur after the balance sheet date up to the date that the financial statements were issued for potential recognition or disclosure. The Company did not identify any subsequent events that would have required adjustment or disclosure in the financial statements.

v3.19.1
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
3 Months Ended
Mar. 31, 2019
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
DESCRIPTION OF THE BUSINESS

Description of the Business

 

Sensus Healthcare, Inc. (the “Company”) is a manufacturer of radiation therapy devices and has established a distribution and marketing network to sell the devices to healthcare providers globally. The Company was organized on May 7, 2010 as a limited liability corporation. On January 1, 2016, the Company completed a corporate conversion pursuant to which Sensus Healthcare, Inc. succeeded to the business of Sensus Healthcare, LLC. In February 2018, the Company opened a subsidiary in Israel. The Company operates as one segment from its corporate headquarters located in Boca Raton, Florida.

BASIS OF PRESENTATION

Basis of Presentation

 

The accompanying unaudited condensed financial statements in this Quarterly Report on Form 10-Q have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, and the rules and regulations of the U.S. Securities and Exchange Commission, or SEC. Accordingly, they do not include certain footnotes and financial presentations normally required under accounting principles generally accepted in the United States of America for complete financial statements. The interim financial information is unaudited, but reflects all normal adjustments and accruals which are, in the opinion of management, considered necessary to provide a fair presentation for the interim periods presented. The accompanying condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto for the year ended December 31, 2018 included in the Company’s Form 10-K, filed with the SEC. The results for the three months ended March 31, 2019 are not necessarily indicative of results to be expected for the year ending December 31, 2019, any other interim periods, or any future year or period.

PRINCIPLES OF CONSOLIDATION

Principles of consolidation

 

The accompanying condensed consolidated financial statements include the financial statements of the Company and its wholly-owned subsidiary in Israel. All inter-company balances and transactions have been eliminated.

USE OF ESTIMATES

Use of Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Significant estimates to which it is reasonably possible that a change could occur in the near term include, inventory reserves, receivable allowances, recoverability of long-lived assets and estimation of the Company’s product warranties. Actual results could differ from those estimates.

REVENUE RECOGNITION

Revenue Recognition

 

On January 1, 2018, the Company adopted Accounting Standards Codification (“ASC”) Topic 606, “Revenue from Contracts with Customers” using the modified retrospective method for all contracts as of the date of adoption. The adoption of this standard did not result in a significant change to the Company’s historical revenue recognition policies and there were no necessary adjustments required to retained earnings upon adoption.

 

Under ASC 606, a performance obligation is a promise within a contract to transfer a distinct good or service, or a series of distinct goods and services, to a customer. Revenue is recognized when performance obligations are satisfied and the customer obtains control of promised goods or services, which is generally upon shipment of the goods and performance of the service. The amount of revenue recognized reflects the consideration to which the Company expects to be entitled to receive in exchange for goods or services. Under the standard, a contract’s transaction price is allocated to each distinct performance obligation. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identifies the contracts with a customer; (ii) identifies the performance obligations within the contract, including whether they are distinct and capable of being distinct in the context of the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when, or as, the Company satisfies each performance obligation.

 

The Company’s revenue consists of sales of the Company’s devices and services related to maintaining and repairing the devices. The agreement for the sale of the devices and the service contract are usually signed at the same time and in some instances a service contract is signed on a stand-alone basis. Revenue for service contracts is recognized over the service contract period on a straight-line basis. The Company determined that in practice no significant discount is given on the service contract when it is offered with the device purchase as compared to when it is sold on a stand-alone basis, by comparing the median selling price of the service contract as stand-alone and the median selling price of the service contract when sold together with the device. The service level provided is identical when the service contract is purchased stand-alone or together with the device. There is no termination provision in the service contract nor any penalties in practice for cancellation of the service contract. The service contract is not considered a performance obligation until it is paid, and it does not provide a material right for a significant discount when purchased with the device. The service portion of a sales contract or a stand-alone service contract is accounted for over the period of time of the service contract only when the customer exercises the option by paying for the service contract.

 

Disaggregated revenue for the three months ended March 31, 2019 and 2018 was as follows:

 

    For the Three Months Ended 
March 31,
 
    2019     2018  
Product Revenue   $ 4,930,924     $ 5,532,647  
Service Revenue     505,675       422,815  
Total Revenue   $ 5,436,599     $ 5,955,462  

 

The Company operates in a highly regulated environment in which state regulatory approval is sometimes required prior to the customer being able to use the product, primarily in the U.S. dermatology market. In these cases, where regulatory approval is pending, revenue is deferred until such time as regulatory approval is obtained.

 

Deferred revenue as of March 31, 2019 was as follows:

 

    Service     Product     Total Deferred Revenue  
Balance, beginning of period   $ 1,455,757     $ 33,000     $ 1,488,757  
Revenue recognized     (368,956 )     (33,000 )     (401,956 )
Amounts invoiced     473,359             473,359  
Balance, end of period   $ 1,560,160     $     $ 1,560,160  

 

The Company does not disclose information about remaining performance obligations of deposits for products that have original expected durations of one year or less. Estimated service revenue to be recognized in the future related to the performance obligations that are unsatisfied (or partially unsatisfied) as of March 31, 2019 is as follows:

 

Year   Service Revenue  
2019 (April 1 – December 31, 2019)   $ 579,785  
2020     539,914  
2021     405,892  
2022     34,569  
Total   $ 1,560,160  

 

 

The Company provides warranties in conjunction with the sale of its products. These warranties entitle the customer to repair, replacement, or modification of the defective product subject to the terms of the respective warranty. The Company records an estimate of future warranty claims at the time the Company recognizes revenue from the sale of the product based upon management’s estimate of the future claims rate.

 

Shipping and handling costs are expensed as incurred and are included in cost of sales.

SEGMENT AND GEOGRAPHICAL INFORMATION

Segment and Geographical Information

 

The Company’s revenue is generated primarily from customers in the United States, which represented approximately 81% and 100% for the three months ended March 31, 2019 and 2018, respectively. A single customer in the US accounted for approximately 53% and 75% of revenues for the three months ended March 31, 2019 and 2018, respectively, and approximately 87% of the accounts receivable as of March 31, 2019 and December 31, 2018, respectively.

CASH AND CASH EQUIVALENTS

Cash and Cash Equivalents

 

The Company maintains its cash and cash equivalents with financial institutions which balances exceed the federally insured limits. Federally insured limits are $250,000 for deposits. As of March 31, 2019 and December 31, 2018, the Company had approximately $5,679,000 and $11,726,000, respectively in excess of federally insured limits.

 

For purposes of the statement of cash flows, the Company considers all highly liquid financial instruments with a maturity of three months or less when purchased to be a cash equivalent.

INVESTMENTS

Investments

 

Short-term investments consist of investments which the Company expects to convert into cash within one year and long-term investments after one year. The Company classifies its investments in debt securities at the time of purchase as held-to-maturity and reevaluates such classification on a quarterly basis. Held-to-maturity investments consist of securities that the Company has the intent and ability to retain until maturity. These securities are carried at amortized cost plus accrued interest and consist of the following:

 

    Amortized
Cost
    Gross
Unrealized
Gain
    Gross
Unrealized
Loss
    Fair
Value
 
Short-Term:                                
Corporate bonds   $ 2,892,190     $     $ 623     $ 2,891,567  
Total Short Term:     2,892,190             623       2,891,567  
                                 
Total Investments December 31, 2018   $ 2,892,190     $     $ 623     $ 2,891,567  
                                 
Short-Term:                                
Corporate bonds   $ 4,699,954     $ 1,226     $     $ 4,701,180  
Total Short Term:     4,699,954       1,226             4,701,180  
                                 
Total Investments March 31, 2019   $ 4,699,954     $ 1,226     $     $ 4,701,180  

 

ACCOUNTS RECEIVABLE

Accounts Receivable

 

The Company does business and extends credit based on an evaluation of each customer’s financial condition, generally without requiring collateral. Exposure to losses on receivables is expected to vary by customer due to the financial condition of each customer. The Company monitors exposure to credit losses and maintains allowances for anticipated losses considered necessary under the circumstances. The allowance for doubtful accounts was $0 as of March 31, 2019 and December 31, 2018. Bad debt expense for the three months ended March 31, 2019 and 2018 was approximately $0 and $2,000, respectively.

INVENTORIES

Inventories

 

Inventories consist of finished product and components and are stated at the lower of cost or net realizable value, determined using the first-in-first-out method.

EARNINGS PER SHARE

Earnings Per Share

 

Basic net income (loss) per share is calculated by dividing the net income (loss) by the weighted-average number of common shares outstanding for the period. The diluted net income per share is computed by giving effect to all potential dilutive common share equivalents outstanding for the period, using the treasury stock method for options and warrants, as well as unvested restricted shares. In periods when the Company has incurred a net loss, options, warrants and unvested shares are considered common share equivalents but have been excluded from the calculation of diluted net loss per share as their effect is antidilutive. Shares were excluded as follows:

 

    For the Three Months Ended 
March 31,
 
    2019     2018  
Warrants     256,035        
Stock options     64,463       3,660  
Shares     70,951        
ADVERTISING COSTS

Advertising Costs

 

Advertising and promotion expenses are charged to expense as incurred. Advertising and promotion expense included in selling expense in the accompanying statements of operations amounted to approximately $539,000 and $522,000 for the three months ended March 31, 2019 and 2018, respectively.

LEASES

Leases

 

The Company evaluates arrangements at inception to determine if an arrangement is or contains a lease. Operating lease assets represent the Company’s right to use an underlying asset for the lease term and operating lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease assets and liabilities are recognized at the commencement date of the lease based upon the present value of lease payments over the lease term. When determining the lease term, the Company includes options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. The Company uses an incremental borrowing rate that the Company would expect to incur for a fully collateralized loan over a similar term under similar economic conditions to determine the present value of the lease payments.

 

The lease payments used to determine the Company’s operating lease assets may include lease incentives and stated rent increases and are recognized in the Company’s operating lease assets in the Company’s condensed consolidated balance sheets. Operating lease assets are amortized to rent expense over the lease term and included in operating expenses in the condensed consolidated statements of operations.

RECENTLY ISSUED AND ADOPTED ACCOUNTING STANDARDS

Recently issued and Adopted accounting Standards

 

In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842).” The guidance in ASU 2016-02 supersedes the lease recognition requirements in ASC Topic 840, Leases (FAS 13). The new standard establishes a right-of-use (“ROU”) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The new standard is effective for fiscal years beginning after December 1, 2018, including interim periods within those fiscal years, with early adoption permitted. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. Early adoption of the amendments in the update is permitted. The Company adopted this standard in the first quarter of 2019 using the modified retrospective approach. The adoption of this standard resulted in the recognition of operating lease right-of-use assets and associated lease liabilities on our balance sheet of approximately $805,000 and $805,000, respectively, as of January 1, 2019. Additional required disclosures have been included within Note 6 - Leases. Such adoption did not have a material impact on our liquidity, results of operations or our compliance with the revolving credit facility covenants.

v3.19.1
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)
3 Months Ended
Mar. 31, 2019
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Schedule of Disaggregation of Revenue

Disaggregated revenue for the three months ended March 31, 2019 and 2018 was as follows:

 

    For the Three Months Ended 
March 31,
 
    2019     2018  
Product Revenue   $ 4,930,924     $ 5,532,647  
Service Revenue     505,675       422,815  
Total Revenue   $ 5,436,599     $ 5,955,462  
Schedule of deferred revenue

Deferred revenue as of March 31, 2019 was as follows:

 

    Service     Product     Total Deferred Revenue  
Balance, beginning of period   $ 1,455,757     $ 33,000     $ 1,488,757  
Revenue recognized     (368,956 )     (33,000 )     (401,956 )
Amounts invoiced     473,359             473,359  
Balance, end of period   $ 1,560,160     $     $ 1,560,160  
Schedule of estimated service revenue recognised

Estimated service revenue to be recognized in the future related to the performance obligations that are unsatisfied (or partially unsatisfied) as of March 31, 2019 is as follows:

 

Year   Service Revenue  
2019 (April 1 – December 31, 2019)   $ 579,785  
2020     539,914  
2021     405,892  
2022     34,569  
Total   $ 1,560,160  
Schedule of investment

These securities are carried at amortized cost plus accrued interest and consist of the following:

 

    Amortized
Cost
    Gross
Unrealized
Gain
    Gross
Unrealized
Loss
    Fair
Value
 
Short-Term:                                
Corporate bonds   $ 2,892,190     $     $ 623     $ 2,891,567  
Total Short Term:     2,892,190             623       2,891,567  
                                 
Total Investments December 31, 2018   $ 2,892,190     $     $ 623     $ 2,891,567  
                                 
Short-Term:                                
Corporate bonds   $ 4,699,954     $ 1,226     $     $ 4,701,180  
Total Short Term:     4,699,954       1,226             4,701,180  
                                 
Total Investments March 31, 2019   $ 4,699,954     $ 1,226     $     $ 4,701,180  
Schedule of antidilutive

Shares were excluded as follows:

 

    For the Three Months Ended 
March 31,
 
    2019     2018  
Warrants     256,035        
Stock options     64,463       3,660  
Shares     70,951        
v3.19.1
PROPERTY AND EQUIPMENT (Tables)
3 Months Ended
Mar. 31, 2019
Property, Plant and Equipment [Abstract]  
Schedule of property and equipment
    As of March 31, 2019     As of December 31, 2018     Estimated Useful Lives  
    (unaudited)                
Operations equipment   $ 854,302     $ 852,273     3 years  
Tradeshow and demo equipment     890,929       784,244     3 years  
Computer equipment     117,666       112,521     3 years  
      1,862,897       1,749,038        
Less accumulated depreciation     (963,105 )     (858,009 )      
Property and Equipment, Net   $ 899,792     $ 891,029        
v3.19.1
PATENT RIGHTS (Tables)
3 Months Ended
Mar. 31, 2019
Goodwill and Intangible Assets Disclosure [Abstract]  
Schedule of intangible assets
    As of March 31,     As of December 31,  
    2019     2018  
    (unaudited)          
Gross carrying amount   $ 1,253,018     $ 1,253,018  
Less accumulated amortization     (843,378 )     (819,281 )
Patent Rights, Net   $ 409,640     $ 433,737  
Schedule of amortization expense

Amortization expense was approximately $24,000 for the three months ended March 31, 2019 and 2018. As of March 31, 2019, future remaining amortization expense is as follows:

 

Year      
2019 (April 1 – December 31, 2019)   $ 72,290  
2020     96,386  
2021     96,386  
2022     96,386  
2023     48,192  
Total   $ 409,640  
v3.19.1
PRODUCT WARRANTIES (Tables)
3 Months Ended
Mar. 31, 2019
Product Warranties Disclosures [Abstract]  
Schedule of changes in product warranty liability

Changes in product warranty liability were as follows for the nine months ended March 31, 2019:

 

Balance, beginning of period   $ 136,217  
Warranties accrued during the period     59,638  
Payments on warranty claims     (57,913 )
Balance, end of period   $ 137,942  
v3.19.1
LEASES (Tables)
3 Months Ended
Mar. 31, 2019
Leases [Abstract]  
Schedule of future minimum lease payments for operating leases

The following table presents information about the amount, timing and uncertainty of cash flows arising from the Company’s operating leases as of March 31, 2019.

 

Maturity of Operating Lease Liabilities   Amount  
2019 (April 1 – December 31, 2019)   $ 187,420  
2020     245,237  
2021     230,674  
2022     176,866  
Total undiscounted operating leases payments   $ 840,197  
Less: Imputed interest     (88,441 )
Present Value of Operating Lease Liabilities   $ 751,756  
         
Other Information        
Weighted-average remaining lease term     3.3 years  
Weighted-average discount rate     5.0 %
v3.19.1
STOCKHOLDERS' EQUITY (Tables)
3 Months Ended
Mar. 31, 2019
Equity [Abstract]  
Schedule of warrant activity

The following table summarizes the Company’s warrant activity:

 

    Common Unit Warrants  
    Number of
Warrants
    Weighted
Average
Exercise
Price
    Weighted
Average
Remaining
Contractual
Term (In Years)
 
Outstanding – December 31, 2018     2,438,000     $ 6.75       0.55  
Granted                  
Exercised     (400,281 )     6.75        
Expired                  
Outstanding – March 31, 2019     2,037,719     $ 6.75       0.32  
Exercisable – March 31, 2019     2,037,719     $ 6.75       0.32  
Schedule of Stock Options, Valuation Assumptions
       
Expected volatility     67.8 %
Risk-free interest rate     2.5 %
Expected life     6.25 years  
Dividend yield     0.0 %
Summary of restricted stock activity

A summary of the restricted stock activity is presented as follows:

 

    Shares     Weighted 
Average
Grant Date Fair
Value
 
Unvested balance at December 31, 2018     165,834     $ 5.84  
Granted            
Vested     (2,500 )     4.99  
Forfeited            
Unvested balance at March 31, 2019     163,334     $ 5.85  
Schedule of option activity

The following table summarizes the Company’s stock option activity:

 

    Number of
Options
    Weighted
Average
Exercise
Price
    Weighted
Average
Remaining
Contractual
Term 
(In Years)
 
Outstanding – December 31, 2018     229,334     $ 5.55       9.08  
Granted                  
Exercised                  
Expired                  
Outstanding – March 31, 2019     229,334     $ 5.55       8.83  
Exercisable – March 31, 2019     57,334     $ 5.55       8.83  
v3.19.1
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details) - USD ($)
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Total Revenue $ 5,436,599 $ 5,955,462
Product [Member]    
Total Revenue 4,930,924 5,532,647
Service [Member]    
Total Revenue $ 505,675 $ 422,815
v3.19.1
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 1)
3 Months Ended
Mar. 31, 2019
USD ($)
Deferred Revenue Arrangement [Line Items]  
Balance, beginning of period $ 1,488,757
Revenue recognized (401,956)
Amounts invoiced 473,359
Balance, end of period 1,560,160
Service [Member]  
Deferred Revenue Arrangement [Line Items]  
Balance, beginning of period 1,455,757
Revenue recognized (368,956)
Amounts invoiced 473,359
Balance, end of period 1,560,160
Product [Member]  
Deferred Revenue Arrangement [Line Items]  
Balance, beginning of period 33,000
Revenue recognized (33,000)
Amounts invoiced
Balance, end of period
v3.19.1
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 2)
Mar. 31, 2019
USD ($)
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
2019 $ 579,785
2020 539,914
2021 405,892
2022 34,569
Total $ 1,560,160
v3.19.1
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 3) - USD ($)
3 Months Ended 12 Months Ended
Mar. 31, 2019
Dec. 31, 2018
Amortized Cost $ 4,699,954 $ 2,892,190
Gross Unrealized Gain 1,226
Gross Unrealized Loss 623
Fair Value 4,701,180 2,891,567
Short Term [Member]    
Amortized Cost 4,699,954 2,892,190
Gross Unrealized Gain 1,226
Gross Unrealized Loss 623
Fair Value 4,701,180 2,891,567
Short Term [Member] | Corporate Bonds [Member]    
Amortized Cost 4,699,954 2,892,190
Gross Unrealized Gain 1,226  
Gross Unrealized Loss  
Fair Value $ 4,701,180 2,891,567
Short Term [Member] | Corporate Bonds [Member]    
Gross Unrealized Gain  
Gross Unrealized Loss   $ 623
v3.19.1
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details 4) - shares
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Warrant [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Antidilutive securities excluded from computation of earnings per share, amount 256,035
Stock options [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Antidilutive securities excluded from computation of earnings per share, amount 64,463 3,660
Shares [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Antidilutive securities excluded from computation of earnings per share, amount 70,951
v3.19.1
ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Details Narrative)
3 Months Ended 12 Months Ended
Mar. 31, 2019
USD ($)
Segment
Mar. 31, 2018
USD ($)
Dec. 31, 2018
USD ($)
Jan. 02, 2019
USD ($)
Number of operating segments | Segment 1      
Cash, FDIC insured amount $ 250,000      
Cash uninsured amount 5,679,000   $ 11,726,000  
Allowance for doubtful accounts receivable, current 0   0  
Bad debt expense (recoveries) $ 2,345    
Advertising and promotion expense $ 539,000 $ 522,000    
Product warranty term 1 year      
Operating lease right-of-use $ 749,114   $ 0 $ 805,000
Lease liabilities $ 751,756     $ 805,000
UNITED STATES        
Reveune percent 81.00% 100.00%    
Customer [Member] | Accounts Receivable [Member] | UNITED STATES        
Reveune percent 87.00%   87.00%  
UNITED STATES | Customer [Member] | Revenue [Member]        
Reveune percent 53.00% 75.00%    
v3.19.1
PROPERTY AND EQUIPMENT (Details) - USD ($)
3 Months Ended
Mar. 31, 2019
Dec. 31, 2018
Property, Plant and Equipment [Line Items]    
Property, plant and equipment, gross $ 1,862,897 $ 1,749,038
Less accumulated depreciation (963,105) (858,009)
Property and Equipment, Net 899,792 891,029
OperationsEquipment [Member]    
Property, Plant and Equipment [Line Items]    
Property, plant and equipment, gross $ 854,302 852,273
Property, plant and equipment, useful Life 3 years  
Tradeshow and Demo Equipment [Member]    
Property, Plant and Equipment [Line Items]    
Property, plant and equipment, gross $ 890,929 784,244
Property, plant and equipment, useful Life 3 years  
Computer Equipment [Member]    
Property, Plant and Equipment [Line Items]    
Property, plant and equipment, gross $ 117,666 $ 112,521
Property, plant and equipment, useful Life 3 years  
v3.19.1
PROPERTY AND EQUIPMENT (Details Narrative) - USD ($)
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Property, Plant and Equipment [Abstract]    
Depreciation expense $ 104,000 $ 76,000
v3.19.1
PATENT RIGHTS (Details) - USD ($)
Mar. 31, 2019
Dec. 31, 2018
Goodwill and Intangible Assets Disclosure [Abstract]    
Gross carrying amount $ 1,253,018 $ 1,253,018
Less accumulated amortization (843,378) (819,281)
Patent Rights, Net $ 409,640 $ 433,737
v3.19.1
PATENT RIGHTS (Details 1) - USD ($)
Mar. 31, 2019
Dec. 31, 2018
Goodwill and Intangible Assets Disclosure [Abstract]    
2019 (April 1 - December 31, 2019) $ 72,290  
2020 96,386  
2021 96,386  
2022 96,386  
2023 48,192  
Patent Rights, Net $ 409,640 $ 433,737
v3.19.1
PATENT RIGHTS (Details Narrative) - USD ($)
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Goodwill and Intangible Assets Disclosure [Abstract]    
Amortization expense $ 24,000 $ 24,000
v3.19.1
REVOLVING CREDIT FACILITY (Details Narrative) - USD ($)
3 Months Ended
Mar. 12, 2013
Mar. 31, 2019
Dec. 31, 2018
Debt Disclosure [Abstract]      
Debt instrument, term 2 years    
Line of credit percentage of borrowing base to accounts receivables 80.00%    
Debt instrument, basis spread on variable rate   0.75%  
Debt instrument, interest rate, effective percentage   6.25%  
Line of credit, outstanding   $ 0 $ 0
Line of credit facility, unused capacity, commitment fee percentage   0.25%  
Line of credit description   On October 31, 2017, the Company amended its revolving credit facility to extend the maturity to October 31, 2019 and to amend the financial covenants. The availability under the amended facility will equal the lesser of the $5 million commitment amount or the borrowing base plus the $2.5 million non-formula sublimit. The borrowing base consists of 80% of eligible accounts receivable, as defined in the agreement.  
v3.19.1
PRODUCT WARRANTIES (Details)
3 Months Ended
Mar. 31, 2019
USD ($)
Movement in Standard and Extended Product Warranty Accrual, Increase (Decrease) [Roll Forward]  
Balance, beginning of period $ 136,217
Warranties accrued during the period 59,638
Payments on warranty claims (57,913)
Balance, end of period $ 137,942
v3.19.1
LEASES (Details) - USD ($)
Mar. 31, 2019
Jan. 02, 2019
Commitments and Contingencies Disclosure [Abstract]    
2019 (April 1 - December 31, 2019) $ 187,420  
2020 245,237  
2021 230,674  
2022 176,866  
Total undiscounted operating leases payments 840,197  
Less: Imputed interest (88,441)  
Present Value of Operating Lease Liabilities $ 751,756 $ 805,000
Other Information    
Weighted-average remaining lease term 3 years 3 months 19 days  
Weighted-average discount rate 5.00%  
v3.19.1
LEASES (Details Narrative) - USD ($)
1 Months Ended 3 Months Ended
Jul. 31, 2010
Mar. 31, 2019
Jan. 02, 2019
Dec. 31, 2018
Leases [Abstract]        
Lease expires   Sep. 30, 2022    
Lease payments increase   3.00%    
Manufacturing agreement contract term 3 years 10 years    
Monthly rental payment   $ 5,300    
Operating Lease Right-of-Use Assets, Net   749,114 $ 805,000 $ 0
Decrease in ROU asset   56,000    
Cash paid for amounts included in present value of operating lease liabilities   62,000    
Operating lease cost   $ 65,000    
v3.19.1
COMMITMENT AND CONTINGENCIES (Details Narrative) - USD ($)
1 Months Ended 3 Months Ended
Jul. 31, 2010
Mar. 31, 2019
Mar. 31, 2018
Dec. 31, 2018
Commitments and Contingencies Disclosure [Abstract]        
Payments to suppliers   $ 1,911,000 $ 1,137,000  
Accounts payable and accrued expenses   $ 663,000   $ 1,041,000
Manufacturing agreement contract term 3 years 10 years    
v3.19.1
EMPLOYEE BENEFIT PLANS (Details Narrative) - USD ($)
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Retirement Benefits [Abstract]    
Expenses related to employee benefit plan $ 28,000 $ 24,000
v3.19.1
STOCKHOLDERS' EQUITY (Details) - $ / shares
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Class of Warrant or Right, Outstanding [Roll Forward]    
Exercised 400,281  
Common Warrants [Member]    
Class of Warrant or Right, Outstanding [Roll Forward]    
Outstanding at beginning 2,438,000  
Granted  
Exercised (400,281) (73,309)
Expired  
Outstanding at ending 2,438,000  
Exercisable at end 2,037,719  
Class of Warrant or Right, Exercise Price of Warrants or Rights [Roll Forward]    
Outstanding at beginning $ 6.75  
Granted  
Exercised 6.75  
Expired  
Outstanding at ending 6.75  
Exercisable at ending $ 6.75  
Class Of Warrant Or Right Weighted Average Remaining Contract Term Of Warrants Or Rights [Roll Forward]    
Outstanding at beginning 6 months 18 days  
Outstanding at ending 3 months 26 days  
Exercisable at ending 3 months 26 days  
v3.19.1
STOCKHOLDERS' EQUITY (Details 1)
3 Months Ended
Mar. 31, 2019
Equity [Abstract]  
Expected volatility 67.80%
Risk-free interest rate 2.50%
Expected life 6 years 2 months 30 days
Dividend yield 0.00%
v3.19.1
STOCKHOLDERS' EQUITY (Details 2)
3 Months Ended
Mar. 31, 2019
$ / shares
shares
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward]  
Unvested balance at beginning | shares 165,834
Granted | shares
Vested | shares (2,500)
Forfeited | shares
Unvested balance at end | shares 163,334
Share-based Compensation Arrangement by Share-based Payment Award, Options, Nonvested, Weighted Average Grant Date Fair Value [Rollforward]  
Unvested balance at beginning | $ / shares $ 5.84
Granted | $ / shares
Vested | $ / shares 4.99
Forfeited | $ / shares
Unvested balance at end | $ / shares $ 5.85
v3.19.1
STOCKHOLDERS' EQUITY (Details 3) - $ / shares
1 Months Ended 3 Months Ended
Jan. 25, 2018
Mar. 31, 2019
Number of Options    
Outstanding at beginning   229,334
Granted  
Exercised  
Expired  
Outstanding at end   229,334
Exercisable at end   57,334
Weighted Average Exercise    
Outstanding at beginning (in dollars per share)   $ 5.55
Granted (in dollars per share) $ 5.55
Exercised  
Expired  
Outstanding at end (in dollars per share)   5.55
Exercisable at end (in dollars per share)   $ 5.55
Outstanding at beginning   9 years 29 days
Outstanding at end   8 years 9 months 29 days
Exercisable at end   8 years 9 months 29 days
v3.19.1
STOCKHOLDERS' EQUITY (Details Narrative) - USD ($)
1 Months Ended 3 Months Ended
Oct. 01, 2018
Jan. 20, 2017
Jun. 02, 2016
Jan. 25, 2018
Dec. 31, 2016
Jun. 30, 2016
Apr. 30, 2013
Mar. 31, 2019
Mar. 31, 2018
Dec. 31, 2018
Common stock, authorized               50,000,000   50,000,000
Common stock, issued               16,546,196   16,512,742
Common stock,outstanding               16,145,915   16,112,461
Common stock, par value               $ 0.01   $ 0.01
Weighted average grant date fair value (in dollars per share)                  
Exercised               400,281    
Intrinsic value of common stock warrants               $ 550,000   $ 1,609,000
Number of restricted stock granted                  
Stock option Granted                  
Weighted Average Exercise Price Stock option Granted (in dollars per share)       $ 5.55          
Options, Vested in Period, Fair Value       $ 444,000            
Stock options fair value       $ 3.52            
Stock options unvested               229,334   229,334
Intrinsic value of Stock options               $ 337,000   $ 427,000
Unrecognized stock compensation expense               1,233,000    
Reduction of stock compensation expense value forfeited               $ 0 $ 39,000  
Treasury stock               33,454   33,454
Common Warrants [Member]                    
Number of warrant outstanding               2,438,000   2,438,000
Warrant exercise price (in dollars per share)               $ 6.75   $ 6.75
Exercised               (400,281) (73,309)  
Forfeited                 (13,067)  
Number of warrant granted                  
Warrant granted exercise price (in dollars per share)                  
Nonemployee Directors [Member]                    
Stock option Granted       80,000            
Investor [Member] | Common Warrants [Member] | Placement Agent [Member]                    
Warrant term             5 years      
Number of warrant outstanding             86,376      
Warrant exercise price (in dollars per share)             $ 4.55      
Percentage of offering price             110.00%      
2016 Equity Incentive Plan [Member]                    
Number of authorized shares under the plan                   397,473
2016 Equity Incentive Plan [Member] | Shares [Member]                    
Vesting period     4 years              
Number of restricted stock granted 30,000 10,000 307,666              
Initial offering price (in dollars per share)     $ 5.25              
Vesting percentage     25.00%              
Description of vesting rights     he restricted shares vest 25% per year over a four-year vesting period and are being recognized as expense on a straight-line basis over the vesting period of the awards.              
2017 Equity Incentive Plan [Member]                    
Number of authorized shares under the plan                   500,000
IPO [Member] | Investor [Member] | Common Warrants [Member]                    
Warrant term           3 years        
Number of warrant granted           2,300,000        
Warrant granted exercise price (in dollars per share)           $ 6.75        
Date of warrants exercisable           Jun. 08, 2019        
Warrant redemption price (in dollars per warrant)           $ 0.01        
IPO [Member] | Underwriter's Representatives [Member] | Common Warrants [Member]                    
Warrant term         4 years          
Number of warrant granted         138,000          
Warrant granted exercise price (in dollars per share)         $ 6.75          
IPO [Member] | Underwriter's Representatives [Member] | Common Warrants [Member] | Maximum [Member]                    
Date of warrants exercisable         Jun. 02, 2021          
IPO [Member] | Underwriter's Representatives [Member] | Common Warrants [Member] | Minimum [Member]                    
Date of warrants exercisable         Jun. 02, 2017          
v3.19.1
INCOME TAXES (Details Narrative) - USD ($)
3 Months Ended
Mar. 31, 2019
Mar. 31, 2018
Income Tax Disclosure [Abstract]    
Tax expense $ 0 $ 0