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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

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

For the quarter ended June 30, 2023

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 001-14053 

Milestone Scientific Inc.

(Exact name of registrant as specified in its charter)  

Delaware

13-3545623

State or other jurisdiction of Incorporation or organization

(I.R.S. Employer Identification No.)

425 Eagle Rock Avenue Suite 403, Roseland, NJ 07068

(Address of principal executive offices)

Registrants telephone number, including area code: 973-535-2717

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

Title of each class

Name of each exchange on which registered

Common Stock, par value $.001 per share

NYSE American

Securities registered pursuant to section 12(g) of the Act:                    NONE.


Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.    ☐ Yes    ☑ No

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.    ☐ Yes    ☑ No

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 every Interactive Data File required to be submitted 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 such files).    ☑ Yes    ☐ No

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 229.405 of this chapter) is not contained herein and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment of this Form 10-K.    ☑

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 the definitions of “large, accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large, accelerated filer

Accelerated filer

    

Non-accelerated filer

Smaller reporting company

    

Emerging Growth Company

  

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.    ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.   ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).   ☐

 

Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐.

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

 

As of August 14, 2023, the registrant has a total of 71,365,659 shares of Common Stock, $0.001 par value outstanding.

true

 

DOCUMENTS INCORPORATED BY REFERENCE

None  

1

 

 

MILESTONE SCIENTIFIC INC.

Form 10-Q 

TABLE OF CONTENTS

 

 

PART IFINANCIAL INFORMATION

 
     

Item 1.

 Condensed Consolidated Financial Statements

 
     
 

Balance Sheets as of June 30, 2023 (Unaudited) and December 31, 2022

4

     
 

Statements of Operations for the three and six months ended June 30, 2023 and 2022 (Unaudited)

5

     
 

Statements of Changes in Stockholders’ Equity for the three and six months ended June 30, 2023 and 2022 (Unaudited)

6

     
 

Statements of Cash Flows for the six months ended June 30, 2023 and 2022 (Unaudited)

8

     
 

Notes to Unaudited Condensed Consolidated Financial Statements 

9

     

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

20

     

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

25

     

Item 4.

Controls and Procedures

25

     
 

PART IIOTHER INFORMATION

 
     

Item 1.

Legal Proceedings

26

     

Item 1A.

Risk Factors

26

     

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

26

     

Item 3.

Defaults Upon Senior Securities

26

     

Item 4.

Mine Safety Disclosures

26

     

Item 5.

Other Information

26

     

Item 6.

Exhibits

27

   

Signatures

28

 

2

 

 

FORWARD-LOOKING STATEMENTS

 

When used in this Quarterly Report on Form 10-Q, the words “may”, “will”, “should”, “expect”, “believe”, “anticipate”, “continue”, “estimate”, “project”, “intend” and similar expressions are intended to identify forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) regarding events, conditions and financial trends that may affect Milestone Scientific’s future plans of operations, business strategy, results of operations and financial condition. Milestone Scientific wishes to ensure that such statements are accompanied by meaningful cautionary statements pursuant to the safe harbor established in the Private Securities Litigation Reform Act of 1995. The forward-looking statements included herein are based on current expectations that involve numerous risks and uncertainties. Milestone Scientific’s plans and objectives are based, in part, on assumptions involving the continued expansion of its business. Assumptions relating to the foregoing involve judgments with respect to, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Milestone Scientific. Although Milestone Scientific believes that its assumptions underlying the forward-looking statements are reasonable, any of the assumptions could prove inaccurate. Considering the significant uncertainties inherent in the forward-looking statements included herein, our history of operating losses that are expected to continue, requiring additional funding which we may be unable to raise capital when needed (which may force us to delay, curtail or eliminate commercialization efforts of our CompuFlo Epidural Computer Controlled Anesthesia System), the early stage operations of and relatively lack of acceptance of our medical products, relying exclusively on two third parties to manufacture our products, changes to our distribution arrangements exposes us to risks of interruption of marketing efforts and building new marketing channels, changes in our informal manufacturing arrangements made by the manufacturer of our products and disruptions at the manufacturing facility of our manufacturers, including shortages of or delays in obtaining chips and other components, exposes us to risks that may harm our business, raising additional funds by issuing securities or through licensing or lending arrangements may cause dilution to our existing stockholders, restrict our operations or require us to relinquish proprietary rights, if physicians do not accept nor use our CompuFlo Epidural Computer Controlled Anesthesia System, our ability to generate revenue from sales will be materially impaired, exposure to the risks inherent in international sales and operations, including China, and developments by competitors may render our products or technologies obsolete or non-competitive, the inclusion of such information should not be regarded as a representation by Milestone Scientific or any other person that the objectives and plans of Milestone Scientific will be achieved. Prospective investors are cautioned that any forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties and the actual results may differ materially from those included within the forward-looking statements as a result of various factors. Such forward-looking statements should, therefore, be considered in light of various important factors, including those set forth herein and others set forth from time to time in Milestone Scientific’s reports, including without limitation, Milestone Scientific's Annual Report on Form 10-K for the year ended December 31, 2022 filed with the Securities and Exchange Commission (the “SEC”). Milestone Scientific disclaims any intent or obligation to update such forward-looking statements. 

 

Milestone Scientific is the owner of the following registered U.S. trademarks: CompuDent®; CompuMed®; CompuFlo®; DPS Dynamic Pressure Sensing technology®; Milestone Scientific ®; CathCheck®; the Milestone logo ®; SafetyWand®; STA Single Tooth Anesthesia Device®; and The Wand ®.3

 

3

 

 

Part I- Financial Information

Item 1. Financial Statements

 

MILESTONE SCIENTIFIC AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

  

June 30, 2023

  

December 31, 2022

 
   (Unaudited)     

ASSETS

        

Current assets:

        

Cash and cash equivalents

 $3,701,453  $8,715,279 

Marketable securities

  1,981,180   - 

Accounts receivable, net

  789,584   693,717 

Prepaid expenses and other current assets

  551,990   443,872 

Inventories

  2,193,063   1,792,335 

Advances on contracts

  1,282,806   1,325,301 

Total current assets

  10,500,076   12,970,504 

Furniture, fixtures and equipment, net

  11,867   18,146 

Intangibles, net

  201,529   227,956 

Right of use assets finance lease

  13,319   17,645 

Right of use assets operating lease

  400,511   443,685 

Other assets

  24,150   24,150 

Total assets

 $11,151,452  $13,702,086 
         
         

LIABILITIES AND STOCKHOLDERS’ EQUITY

        

Current liabilities:

        

Accounts payable

 $674,587  $1,102,729 

Accounts payable, related party

  626,690   803,492 

Accrued expenses and other payables

  1,422,506   1,124,839 

Accrued expenses, related party

  278,339   167,549 

Current portion of finance lease liabilities

  9,805   9,365 

Current portion of operating lease liabilities

  97,429   91,701 

Total current liabilities

  3,109,356   3,299,675 

Non-current portion of finance lease liabilities

  5,683   10,698 

Non-current portion of operating lease liabilities

  334,750   385,279 

Total liabilities

 $3,449,789  $3,695,652 
         

Commitments

          
         

Stockholders’ equity

        

Common stock, par value $.001;authorized 100,000,000 shares; 70,107,739 shares issued and 70,074,406 shares outstanding as of June 30, 2023; 69,306,497 shares issued and 69,273,164 shares outstanding as of December 31, 2022;

  70,108   69,306 

Additional paid in capital

  128,720,911   127,478,325 

Accumulated deficit

  (119,934,388)  (116,410,405)

Treasury stock, at cost, 33,333 shares

  (911,516)  (911,516)

Total Milestone Scientific, Inc. stockholders' equity

  7,945,115   10,225,710 

Noncontrolling interest

  (243,452)  (219,276)

Total stockholders’ equity

  7,701,663   10,006,434 
         

Total liabilities and stockholders’ equity

 $11,151,452  $13,702,086 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

4

 

 

 

MILESTONE SCIENTIFIC AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

                 
  

For the three months ended June 30, 2023

  

For the three months ended June 30, 2022

  

For the six months ended June 30, 2023

  

For the six months ended June 30, 2022

 
                 

Product sales, net

 $2,909,966  $1,648,368  $5,507,564  $4,349,270 

Cost of products sold

  1,019,907   967,720   1,728,882   1,986,196 

Gross profit

  1,890,059   680,648   3,778,682   2,363,074 
                 

Selling, general and administrative expenses

  3,937,281   3,282,322   7,011,012   6,397,948 

Research and development expenses

  213,647   266,560   353,994   731,027 

Depreciation and amortization expense

  16,681   16,645   33,902   33,460 

Total operating expenses

  4,167,609   3,565,527   7,398,908   7,162,435 
                 

Loss from operations

  (2,277,550)  (2,884,879)  (3,620,226)  (4,799,361)

Interest income (expense)

  48,722   3,550   72,067   (1,193)

Loss before provision for income taxes

  (2,228,828)  (2,881,329)  (3,548,159)  (4,800,554)

Net loss

  (2,228,828)  (2,881,329)  (3,548,159)  (4,800,554)

Net loss attributable to noncontrolling interests

  (12,511)  (22,848)  (24,176)  (40,350)

Net loss attributable to Milestone Scientific Inc.

 $

(2,216,317

) $(2,858,481) $(3,523,983) $(4,760,204)
                 

Net loss per share applicable to common stockholders—

                

Basic and Diluted

  (0.03)  (0.04)  (0.05)  (0.07)
                 

Weighted average shares outstanding and to be issued—

                

Basic and Diluted

  72,333,656   70,356,796   72,048,223   70,585,590 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

5

 
 

MILESTONE SCIENTIFIC AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY

FOR THREE AND SIX MONTHS ENDED JUNE 30, 2023

(UNAUDITED)

 

    Common Stock     Common Stock Amount     Additional Paid in Capital     Accumulated Deficit     Noncontrolling Interest     Treasury Stock     Total Stockholder Equity  

Balance January 1, 2023

    69,306,497     $ 69,306     $ 127,478,325     $ (116,410,405 )   $ (219,276 )   $ (911,516 )   $ 10,006,434  

Stock based compensation

    -       -       388,772       -       -       -       388,772  

Common stock issued to board of directors for services

    256,868       258       (258 )     -       -       -       -  

Common stock to be issued to employees for bonuses

    -       -       50,000       -       -       -       50,000  

Common Stock issued to Consultants

    242,335       242       125,758       -       -       -       126,000  

Net loss

    -       -       -       (1,307,666 )     (11,665 )     -       (1,319,331 )

Balance at March 31, 2023

    69,805,700     $ 69,806     $ 128,042,597     $ (117,718,071 )   $ (230,941 )   $ (911,516 )   $ 9,251,875  

Stock based compensation

  -     -    

404,330

   

-

   

-

   

-

   

404,330

 

Common stock to be issued for payment of consulting services

    109,204       109       56,677       -       -       -       56,786  

Common stock issued to board of directors for services

    192,835       193       (193)       -       -       -       -  

Common stock to be issued to employees for bonuses

    -       -       217,500       -       -       -       217,500  

Net loss

    -       -               (2,216,317 )     (12,511 )     -       (2,228,828 )

Balance at June 30, 2023

    70,107,739     $ 70,108     $ 128,720,911     $ (119,934,388 )   $ (243,452 )   $ (911,516 )   $ 7,701,663  

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

6

 

 

MILESTONE SCIENTIFIC AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY

FOR THREE AND SIX MONTHS ENDED JUNE 30, 2022

(UNAUDITED)

 

   

Common Stock

   

Common Stock Amount

   

Additional Paid in Capital

   

Accumulated Deficit

   

Noncontrolling Interest

   

Treasury Stock

   

Total Stockholder Equity

 

Balance January 1, 2022

    68,153,336     $ 68,153     $ 124,915,560     $ (107,704,274 )   $ (152,541 )   $ (911,516 )   $ 16,215,382  

Stock based compensation

    -       -       305,370       -       -       -       305,370  

Common stock to be issued to employees for bonuses

    -       -       164,385       -       -       -       164,385  

Net loss

    -       -       -       (1,901,723 )     (17,502 )     -       (1,919,225 )

Balance at March 31, 2022

    68,153,336     $ 68,153     $ 125,385,315     $ (109,605,997 )   $ (170,043 )   $ (911,516 )   $ 14,765,912  

Stock based compensation

    -       -       392,266       -       -       -       392,266  

Common stock issued to employee for compensation

    27,051       27       39,973       -       -       -       40,000  

Common stock to be issued for payment of consulting services

    246,028       246       345,689       -       -       -       345,935  

Common stock issued to board of directors for services

    12,879       13       12,864       -       -       -       12,877  

Common stock to be issued to employees for bonuses

    224,850       225       (225 )     -       -       -       -  

Common stock to be issued to employees for bonuses

    147,338       147       (147 )     -       -       -       -  

Net loss

    -       -       -       (2,858,481 )     (22,848 )     -       (2,881,329 )

Balance at June 30, 2022

    68,811,482     $ 68,811     $ 126,175,735     $ (112,464,478 )   $ (192,891 )   $ (911,516 )   $ 12,675,661  

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

7

 
 

MILESTONE SCIENTIFIC AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

FOR THE SIX MONTHS ENDED

(UNAUDITED) 

   

June 30, 2023

   

June 30, 2022

 

Cash flows from operating activities:

               

Net loss

  $ (3,548,159 )   $ (4,800,554 )

Adjustments to reconcile net loss to net cash used in operating activities:

               

Depreciation expense

    7,473       6,692  

Amortization of intangibles

    26,429       26,768  

Stock based compensation

    793,101       697,635  

Inventory Reserve

    -       430,245  

Employees paid in stock

    267,500       217,262  

Expense paid in stock

    182,786       345,935  

Amortization of right-of-use asset

    45,624      

43,491

 

Changes in operating assets and liabilities:

               

Increase in accounts receivable

    (95,867 )     117,926  

Increase in accounts receivable, related party

    -       (269,973 )

(Decrease) in inventories

    (400,728 )     (394,167 )

(Decrease) increase in advances on contracts

    42,495       (321,597 )

Increase in prepaid expenses and other current assets

    (108,118 )     (147,578 )

(Decrease) increase in accounts payable

    (428,141 )     604,976  

(Decrease) increase in accounts payable, related party

    (176,803 )     337,801  

Increase (decrease) in accrued expenses

    297,666       (464,800 )

Increase (decrease) in accrued expenses, related party

    110,790       (191,789 )

Decrease operating right of use lease asset

    (43,174 )     (39,338 )

Net cash used in operating activities

  $ (3,027,126 )   $ (3,801,065 )
                 

Cash flows from investing activities:

               

Purchase of furniture, fixtures, and equipment

    (1,196 )     85  

Purchase of Marketable securities

    (1,981,180 )     -  

Net cash (used in) provided by investing activities

  $ (1,982,376 )   $ 85  
                 

Cash flows from financing activities:

               

Payments finance lease obligations

    (4,324 )     (4,234 )

Net cash used in financing activities

  $ (4,324 )   $ (4,234 )
                 

Net decrease in cash and cash equivalents

    (5,013,826 )     (3,805,214 )

Cash and cash equivalents at beginning of period

    8,715,279       14,764,346  

Cash and cash equivalents at end of period

  $ 3,701,453     $ 10,959,132  

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

8

 

MILESTONE SCIENTIFIC, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)  

 

NOTE 1 ORGANIZATION AND BUSINESS

 

All references in this report to “Milestone Scientific,” “us,” “our,” “we,” the “Company” or “Milestone” refer to Milestone Scientific Inc., and its consolidated subsidiaries, Wand Dental, Inc., and Milestone Medical, Inc. (all described below), unless the context otherwise indicates. Milestone Scientific is the owner of the following registered U.S. trademarks: CompuDent®; CompuFlo®; DPS Dynamic Pressure Sensing technology®; Milestone Scientific ®; CathCheck®; the Milestone logo ®; SafetyWand®; STA Single Tooth Anesthesia System®; and The Wand ®. 

 

Milestone Scientific was incorporated in the State of Delaware in August 1989. Milestone Scientific has developed a proprietary, revolutionary, computer-controlled anesthetic delivery device, its DPS Dynamic Pressure Sensing Technology® System, to meet the needs of various subcutaneous drug delivery injections and fluid aspiration – enabling healthcare practitioners to achieve multiple unique benefits that cannot currently be accomplished with the 160-year-old manual syringe. The device, using The Wand®, a single use disposable handpiece, is marketed in dentistry under the trademarks CompuDent® and STA Single Tooth Anesthesia System®, and is suitable for all dental procedures that require local anesthetic. The dental devices are sold in the United States, Canada and in 38 other countries. Milestone Scientific also has 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) on the CompuFlo® Epidural Computer Controlled Anesthesia System in the lumbar thoracic and cervical thoracic junction of the spinal region. In addition, certain medical devices have obtained CE mark approval and can be marketed and sold in most European countries.

 

Milestone Scientific is a biomedical technology company that patents, designs, develops and commercializes innovative diagnostic and therapeutic injection technologies and devices for medical and dental use. Since our inception, we have engaged in pioneering proprietary, innovative, computer-controlled injection technologies, and solutions for the medical and dental markets. Our common stock was initially listed on the NYSE American on June 1, 2015 and trades under the symbol “MLSS”. The Company is focused on building its intellectual property portfolio across numerous indications.

 

 

NOTE 2-  LIQUIDITY  AND UNCERTAINTIES    

 

The Company has evaluated whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company's ability to continue as a going concern within one year after the date that the unaudited condensed consolidated financial statements are issued. Total losses since inception have been $120 million. The operating losses were $2.3 million and $3.6 million for three and six months ended June 30, 2023, respectively. Management has prepared cash flow forecasts covering a period of 12 months from the date of issuance of these financial statements. As a result of the forecast, management believes that the Company has sufficient cash, along with the current cash flow and support from the dental business to mitigate the expected selling expenditures for commercialization of the Epidural medical device, as well as other operating expenditures and planned new product development programs, over the next twelve months from the filing date of this report, and thus has concluded that there is no substantial doubt about the Company’s ability to continue as a going concern. 

 

These forecasts include several revenue and operating expense assumptions which indicate that the Company’s current cash and liquidity is sufficient to finance the operating requirements for at least the next twelve months. Management believes that the Company will have sufficient cash reserves to meet its anticipated obligations for at least the next twelve months from the filing date of this report. Milestone Scientific is actively pursuing the generation of positive cash flows from operating activities through an increase in revenue from its dental business worldwide, the generation of revenue from its medical devices and disposables business in the United States and worldwide, and a reduction in operating expenses. However, the Company’s continued operations will depend on its ability to raise additional capital through various potential sources until it achieves profitability, if ever.

 

In addition to its employees, the Company relies on (i) distributors, agents, and third-party logistics providers in connection with product sales and distribution, and (ii) raw material and component suppliers in the U.S., Europe, and China. If the Company, or any of these entities, encounter any disruptions to its or their respective operations or facilities, or if the Company or any of these third-party partners were to shut down for any reason, including by fire, natural disaster, such as a hurricane, tornado or severe storm, power outage, systems failure, labor dispute, pandemic or other public health crises, or other unforeseen disruption, then the Company or they may be prevented or delayed from effectively operating its or their business, respectively.

 

Sanctions imposed by the United States and other western democracies, against Russia because of the Ukraine conflict, and any expansion of the conflict, have had and are likely to continue to have unpredictable and wide-ranging effects on the domestic and global economy and financial markets, which could have an adverse effect on our business and results of operations. The conflict has caused market volatility, a sharp increase in certain commodity prices, and an increasing number and frequency of cybersecurity threats. As direct impact from the conflict, we have experienced a decrease in international sales to Ukraine and halted all sales to Russia. We will continue to monitor the situation carefully and, if necessary, take action to protect our business, operations, and financial condition.

9

 

 

NOTE 3 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

1.  Principles of Consolidation

 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States ("GAAP") and the applicable rules and regulations of the Securities and Exchange Commission (SEC), and include the accounts of Milestone Scientific and its wholly owned and majority owned subsidiaries, including, Wand Dental (wholly owned), and Milestone Medical (majority owned).  All significant, intra-entity transactions and balances have been eliminated in the consolidation.

 

2. Basis of Presentation

 

The unaudited condensed consolidated financial statements of Milestone Scientific have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) for interim financial information with the instructions for Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete annual financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements contain all adjustments (consisting of normal recurring entries) necessary to fairly present such interim results. Interim results are not necessarily indicative of the results of operations which may be expected for a full year or any subsequent period. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto for the year ended December 31, 2022, included in Milestone Scientific's Annual Report on Form 10-K.

 

3. Use of Estimates

 

The preparation of unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions in determining the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. The most significant estimates relate to the allowance for doubtful accounts, inventory valuation, cash flow assumptions regarding evaluations of going concern considerations, stock compensation expense, and valuation allowances on deferred tax assets. Actual results could differ from those estimates.

 

4.  Revenue Recognition

 

The Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To perform revenue recognition, the Company performs the following five steps:

 

i.

identification of the promised goods or services in the contract;

ii.

determination of whether the promised goods or services are performance obligations including whether they are distinct

in the context of the contract;        

iii.

measurement of the transaction price, including the constraint on variable consideration;

iv.

allocation of the transaction price to the performance obligations based on estimated selling prices; and

v.

recognition of revenue when (or as) the Company satisfies each performance obligation. A performance obligation is a

promise in a contract to transfer a distinct good or service to the customer and is the unit of account in ASC 606.

 

The Company derives its revenues from the sale of its products, primarily dental instruments, handpieces, and other related products. The Company sells its products directly to consumers in the United States and through a global distribution network that includes both exclusive and non-exclusive distribution agreements with related and third parties.

 

Revenue from product sales is recognized upon transfer of control of a product to a customer, generally upon date of shipment. The Company has no obligation on product sales for any installation, set-up, or maintenance, these being the responsibility of the buyer. Milestone Scientific's only obligation after sale is the normal commercial warranty against manufacturing defects if the alleged defective unit is returned within the warranty period. 

 

E-Commerce

 

As of January 3, 2023, the Company launched an E-Commerce platform, selling and shipping STA Single Tooth Anesthesia Systems® (STA) and handpieces directly to dental offices and dental groups within the United States. Our  E-commerce portal accepts online payments via credit and debit cards. The cost of delivery is charged to customer along with appropriate sales tax. The Company recognizes revenue from product sales at the time the product ships to a customer via a third party. 

 

10

Sales Returns

 

The Company records allowances for product returns as a reduction of revenue at the time product sales are recorded. Several factors are considered in determining whether an allowance for product returns is required, including the customers’ return rights and the Company’s historical experience with returns and the amount of product in the distribution channel not consumed by end users and subject to return. The Company relies on historical return rates to estimate returns.

 

The Company terminated its major U.S. distributor contract as of December 31, 2022. That distributor had return rights in connection with this contract termination that extended through March 31, 2023. The Company recorded allowance of approximately $179,000 for those returns within its December 31, 2022 financial statements. No returns have been  presented, and the Company reversed the allowance for sales returns.

 

Financing and Payment

 

The Company's payment terms differ by geography and customer, but payments from distributors are required within 90 days or less from the date of shipment. The E-commerce portal sells directly to end users and accepts online payments via credit and debit cards via a third-party. These payments from the third-party are settled within two business days.

 

Disaggregation of Revenue

 

The Company operates in two operating segments: dental and medical. Therefore, results of the Company's operations are reported on a consolidated basis for purposes of segment reporting, consistent with internal management reporting. See Note 8 for revenues by geographical market, based on the customer’s location, and product category for the three and six months ended June 30, 2023 and 2022.

 

5.  Cash and Cash Equivalents

 

Milestone Scientific considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. As of June 30, 2023 and December 31, 2022, Milestone Scientific has approximately $3.7 million and $8.7 million, respectively of cash and cash equivalents. As of June 30, 2023 and December 31, 2022, Milestone Scientific had approximately $3.4 million and $8.3 million, respectively, in cash, cash equivalents, and marketable securities in accounts that exceeded the Federal Deposit Insurance Corporation insurance limit of $250,000.

 

6. Marketable Securities

 

The Company’s marketable securities are comprised of treasury bills with original maturity greater than three months from date of purchase. The Company’s marketable securities are measured at fair value and are accounted for in accordance with ASU 2016-01. Unrealized holding gains and losses on treasury bills are recorded in net realized and unrealized gain (loss) from investments on the unaudited condensed consolidated statements of operations. Dividend and interest income are recognized when earned. Realized gains and losses are included in earnings and are derived using the specific identification method for determining the cost of the marketable securities.

 

The appropriate classification of marketable securities is determined at the time of purchase and evaluated as of each reporting balance sheet date. Investments in marketable debt and equity securities classified as available-for-sale are reported at fair value. Fair value is determined using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or liabilities or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Declines in the fair values of equity securities that are considered other-than-temporary, are charged to other income (expense), net. The Company considers available evidence in evaluating potential impairments of its investments, including the duration and extent to which fair value is less than cost. As of  June 30, 2023, the Company held approximately $2.0 million in  U.S. treasury securities, with  maturity dates within 3 and 6 months of the balance sheet date.

 

7.  Accounts Receivable

 

The e-commerce portal sells directly to end users and accepts online payments via credit and debit cards via a third-party credit card processor. These payments are settled within 2 business days of the transactions. Sales to distributors are on credit terms. The Company estimates losses from the ability or inability of its distributor to make payments on amounts billed.

 

Distributors credit sales are due in 90 days or less from the date of invoicing. As of June 30, 2023 and  December 31, 2022, accounts receivable was recorded, net of allowance for doubtful accounts of $27,000 and $10,000, respectively.

 

11

 

8.  Inventories

 

Inventories principally consist of finished goods and component parts stated at the lower of cost (first-in, first-out method) or net realizable value. Inventory quantities on hand are reviewed on a quarterly basis and a provision for excess, slow moving, defective, and obsolete inventory is recorded if required based on past and expected future sales, potential technological obsolescence, and product expiration requirements.

 

The valuation allowance creates a new cost basis for the inventory, and it is not subsequently marked up through a reduction in the valuation allowance based on any changes in the underlying facts and circumstances. When the valuation allowance is initially recorded, the increase to the allowance is recognized as an increase in cost of sales. The valuation allowance is only reduced if or when the underlying inventory is sold or destroyed, at which time cost of sales recognized would include the previous adjusted cost basis.

 

9.  Basic and Diluted Net Loss Per Common Share

 

Milestone Scientific presents “basic” earnings (loss) per common share applicable to common stockholders and, if applicable, “diluted” earnings (loss) per common share applicable to common stockholders pursuant to the provisions of ASC 260, “Earnings per Share”. Basic earnings (loss) per common share is calculated by dividing net income or loss applicable to common stockholders by the weighted average number of common shares outstanding and to be issued common shares as follows: 72,333,656 and 70,356,796 for the three months ended June 30, 2023 and 2022, respectively; and 72,048,223 and 70,585,590 for the six months ended June 30, 2023 and 2022, respectively. The calculation of diluted earnings per common share is like that of basic earnings per common share, except that the denominator is increased to include the number of additional common shares that would have been outstanding if all potentially dilutive common shares, such as those issuable upon the exercise of stock options and warrants were issued during the period.

 

Since Milestone Scientific had net losses in the six months ended June 30, 2023 and 2022, the assumed effects of the exercise of potentially dilutive outstanding stock options, unissued restricted stock awards (“RSA”) and warrants, were not included in the calculation as their effect would have been anti-dilutive. Such outstanding options, RSA's and warrants totaled  4,142,155 and 8,166,380 for the six months ended on June 30, 2023 and  2022, respectively.

 

10. Stock-Based Compensation 
 

Milestone Scientific accounts for stock-based compensation under ASC Topic 718, Share-Based Payment. ASC Topic 718 requires all share-based payments to employees, non-employees, directors, and officers, including grants of employee stock options, to be recognized in the unaudited condensed consolidated statements of operations over the service period, as an operating expense, based on the grant-date fair values.

 

11.  Recent Accounting Pronouncements

 

In June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which amends the guidance on measuring credit losses for certain financial assets measured at amortized cost, including trade receivables. The FASB has subsequently issued several updates to the standard, providing additional guidance on certain topics covered by the standard. This update requires entities to recognize an allowance for credit losses using a forward-looking expected loss impairment model, taking into consideration historical experience, current conditions, and supportable forecasts that impact collectability.

 

In November 2019, the FASB issued ASU 2019-10, Financial Instruments - Credit Losses (Topic, 326), Derivatives and hedging (Topic 815), and Leases (Topic 842): Effective dates, which deferred the effective date of ASU 2016-13 for the Company. As a result of ASU 2019-10, ASU 2016-13 is effective for all entities with fiscal years beginning after December 15, 2022, including interim periods.  As January 1, 2023, the Company adopted  ASU 2019-10, Financial Instruments - Credit Losses (Topic, 326), Derivatives and hedging (Topic 815), and Leases (Topic 842) the adoption of this ASU does not have a material impact on our financial statements.

 

12

 
 

NOTE 4 — INVENTORIES

 

Inventories consist of the following:

  

June 30, 2023

  

December 31, 2022

 
         

Dental finished goods

 $1,833,864  $1,315,263 

Medical finished goods

  208,081   334,124 

Component parts and other materials

  151,118   142,948 

Total inventories

 $2,193,063  $1,792,335 

 

The Company has recorded an allowance on slow moving Medical finished goods due to the slow adoption of the epidural instruments and handpieces for approximately $1.1 million and $1.0 million  as of June 30, 2023 and December 31, 2022, respectively.

 

 

NOTE 5 — ADVANCES ON CONTRACTS

 

The advances on contracts represent funding of future STA devices, epidural instruments, and epidural replacements parts. The balance of the advances as of June 30, 2023 and December 31, 2022 is approximately $1.3 million, respectively. The advance is classified as current based on the estimated annual usage of the underlying inventory.  

 

 

NOTE 6 STOCKHOLDERS EQUITY

 

Warrants

 

The following table summarizes information about shares issuable under warrants outstanding as of June 30, 2023:

  

Warrant shares outstanding

  

Weighted Average exercise price

  

Weighted Average remaining life

  

Intrinsic value

 
                 

Outstanding at January 1, 2023

  4,268,221   2.18   0.50   - 

Issued

  -   -   -   - 

Exercised

  -   -   -   - 

Expired or cancelled

  (3,953,649)  -   -   - 

Outstanding and exercisable at June 30, 2023

  314,572   0.50   0.60   116,549 

 

Shares to Be Issued

 

As of June 30, 2023 and 2022, there were 2,380,068 and 1,852,789 respectively of shares to be issued whose issuance has been deferred under the terms of employment agreements with the Chief Executive Officer, and other employees of Milestone Scientific. Such shares will be issued to each party upon termination of their employment.

 

As of June 30, 2023and 2022, there were 382,697 and 174,364 respectively of  shares to be issued to non-employees,  for services rendered. The number of shares was fixed at the date of grant and were fully vested upon grant date.

 

The following table summarizes information about shares to be issued on June 30, 2023 and 2022.

  

June 30, 2023

  

June 30, 2022

 
         

Shares-to-be-issued, outstanding January 1, 2023 and 2022, respectively

  2,440,673   2,066,343 

Granted in current period

  322,092   108,148 

Issued in current period

  -   (147,338)

Shares-to be issued outstanding June 30, 2023 and 2022, respectively

  2,762,765   2,027,153 
13

 

Stock Options Plans

 

The Milestone Scientific Inc. 2020 Equity Compensation Plan, as amended and restated (the "2020 Plan"), provides for awards of restricted common stock, restricted stock units, options to purchase common stock and other awards, up to a maximum 11,500,000 shares of common stock and expires in June 2031. Options may be granted to employees, directors, and consultants of Milestone Scientific for the purchase of shares of common stock at a price not less than the fair market value of common stock on the date of grant. In general, options become exercisable over a three-year period from the grant date and expire five years after the date of grant.

 

Milestone Scientific recognizes compensation expense over the requisite service period. For three and six months ended June 30, 2023 Milestone Scientific recognized approximately $229,000 and $457,000 of total employee compensation cost, respectively, recorded in general and administrative expenses on the statement of operations. For three and six months ended June 30, 2022 Milestone Scientific recognized $223,000 and $501,000 of total employee compensation cost, respectively, recorded in general and administrative expenses on the statement of operations.

 

A summary of option activity for employees under the plans and changes during the six months ended June 30, 2023 is presented below:     

  

Number of Options

  

Weighted Averaged Exercise Price $

  

Weighted Average Remaining Contractual Life (Years)

  

Aggregate Intrinsic Options Value $

 

Options outstanding January 1, 2023

  3,059,989   2.36   6.38   - 

Granted during 2023

  -   -       - 

Exercised during 2023

  -   -   -   - 

Forfeited or expired during 2023

  -   -   -   - 

Options outstanding June 30, 2023

  3,059,989   2.36   5.88   - 

Exercisable, June 30, 2023

  1,481,651   2.29   5.25   - 

 

A summary of option activity for non-employees under the plans and changes during the six months ended June 30, 2023 presented below:

  

Number of Options

  

Weighted Averaged Exercise Price $

  

Weighted Average Remaining Contractual Life (Years)

  

Aggregate Intrinsic Options Value $

 

Options outstanding January 1, 2023

  91,663   1.75   2.55   1,083 

Granted during 2023

  8,333   0.89   4.99   - 

Exercised during 2023

  -   -   -   - 

Options outstanding June 30, 2023

  99,996   1.68   2.29   7,516 

Exercisable, June 30, 2023

  86,109   1.78   1.96   6,736 

 

For the three and six months ended June 30, 2023, Milestone Scientific recognized approximately $4,900 and $12,700 expense related to non-employee options, respectively. For the three and six months ended June 30, 2022, Milestone Scientific recognized approximately $5,000 and $10,000 expense related to non-employee options, respectively.

 

The information below summarizes the restricted stock award activity for the six months ended June 30, 2023.

  

Number of Shares

  

Weighted Average Grant-Date Fair Value per Award

 

Non-vested as January 1, 2023

  435,293   1.18 

Granted

  617,978   0.89 

Vested

  (540,164)  - 

Cancelled

  -   - 

Non-vested as June 30, 2023

  513,107   0.96 

 

14

 

As of June 30, 2023, there are 49,615 restricted shares granted and deferred under the terms of  employment agreements with each Territory Manager of Milestone Scientific. Such shares will be issued to each party upon completion of 2 years of employment. For the three and six months ended June 30, 2023, the Company recognized stock compensation expense of approximately $9,400 and $19,000 respectively. For the three and six months ended June 30, 2022, the Company recognized negative stock compensation expense of approximately $54,000 and $27,000, respectively, due to termination of certain employees who had not vested in their grant in the current period.  For the six months ended June 30, 2023, the total unrecognized compensation expense was approximately $19,000, related to unvested restricted stock awards, which the Company expects to recognize over an estimated weighted-average period of .53 years. 

 

As of  June 28, 2023, the Company entered into restricted stock agreements with members of the Board of Directors of the Company. The Company granted 617,978 restricted stock awards with a fair market value of $0.89 per share. Such restricted stock vests as follows: 25% on the grant date in June 2023, and 25% quarterly, on the first day of the following months:  October 2023,  January 2023, and  April 2024. These awards vest immediately upon a change of control as defined in the agreements. For the three and six months of June 30, 2023, the Company recognized approximately $162,000 and $307,000 for restricted stock expenses recorded in general and administrative expenses on the statement of operations. For the six months of  June 30, 2023, the total unrecognized stock compensation expense was approximately $407,000 related to non-vested restricted stock awards with the members of the Board of Directors, which the Company expects to recognize over an estimated weighted average period of .75 years. 

 

 

NOTE 7 — INCOME TAXES

 

The utilization of Milestone Scientific's net operating losses may be subject to a substantial limitation due to the "change of ownership provisions" under Section 382 of the Internal Revenue Code and similar state provisions. Such limitation may result in the expiration of the net operating loss carry forwards before their utilization. Milestone Scientific has established a 100% valuation allowance for all its deferred tax assets due to uncertainty as to their future realization. 

 

 

NOTE 8 — SEGMENT AND GEOGRAPHIC DATA

 

We conduct our business through two reportable segments: Dental and Medical. These segments offer different products and services to different customer bases. The Company provides general corporate services to its segments; however, these services are not considered when making operating decisions and assessing segment performance. These services are reported under “Corporate Services” below and these include costs associated with executive management, investor relations, patents, trademarks, licensing agreements, new instruments developments, financing activities and public company compliance.

 

The following tables present information about our reportable and operating segments:

  

For the Three Months ended June 30, 

  

For the Six Months ended June 30, 

 

Sales

                

Net Sales:

 

2023

  

2022

  

2023

  

2022

 

Dental

 $2,912,166  $1,609,768  $5,503,564  $4,303,120 

Medical

  (2,200)  38,600   4,000   46,150 

Total net sales

 $2,909,966  $1,648,368  $5,507,564  $4,349,270 
                 

Operating Income (Loss):

 

2023

  

2022

  

2023

  

2022

 

Dental

 $598,944  $163,022  $1,240,884  $517,262 

Medical

  (863,899)  (1,615,283)  (1,685,832)  (2,851,374)

Corporate

  (2,012,595)  (1,432,618)  (3,175,278)  (2,465,249)

Total operating loss

 $(2,277,550) $(2,884,879) $(3,620,226) $(4,799,361)
                 

Depreciation and Amortization:

 

2023

  

2022

  

2023

  

2022

 

Dental

 $1,219  $893  $2,388  $1,786 

Medical

  694   1,019   1,662   2,037 

Corporate

  14,768   14,733   29,852   29,637 

Total depreciation and amortization

 $16,681  $16,645  $33,902  $33,460 

 

15

 
                 

Income (loss) before taxes and equity in earnings of affiliates:

 

2023

  

2022

  

2023

  

2022

 

Dental

 $599,126  $161,774  $1,240,295  $514,571 

Medical

  (865,735)  (1,616,733)  (1,689,503)  (2,854,273)

Corporate

  (1,962,219)  (1,426,370)  (3,098,951)  (2,460,852)

Total loss before taxes and equity in earnings of affiliate

 $(2,228,828) $(2,881,329) $(3,548,159) $(4,800,554)
                 

Total Assets

 

June 30, 2023

  

December 31, 2022

         

Dental

 $4,439,751  $3,875,978         

Medical

  452,974   620,373         

Corporate

  6,258,727   9,205,735         

Total assets

 $11,151,452  $13,702,086         

 

The following table shows a breakdown of Milestone Scientific’s product sales (net), domestically and internationally, by business segment product category: 

 

  

Three Months Ended June 30, 2023

  

Three Months Ended June 30, 2022

 

Domestic: US

 

Dental

  

Medical

  

Grand Total

  

Dental

  

Medical

  

Grand Total

 

Instruments

 $271,215  $-  $271,215  $155,028  $-  $155,028 

Handpieces

  1,130,122   (2,200)  1,127,922   801,533   18,600   820,133 

Accessories

  21,443   -   21,443   22,621   -   22,621 

Grand Total

 $1,422,780  $(2,200) $1,420,580  $979,182  $18,600  $997,782 
                         

International: Rest of World

                     

Instruments

 $474,250  $-  $474,250  $160,814  $-  $160,814 

Handpieces

  732,894   -   732,894   459,799   20,000   479,799 

Accessories

  12,242   -   12,242   9,973   -   9,973 

Grand Total

 $1,219,386  $-  $1,219,386  $630,586  $20,000  $650,586 
                         

International: China 

                      

Instruments

 $270,000  $-  $270,000  $-  $-  $- 

Handpieces

  -   -   -   -   -   - 

Accessories

  -   -   -   -   -   - 

Grand Total

 $270,000  $-  $270,000  $-  $-  $- 
                         

Total Product Sales

 $2,912,166  $(2,200) $2,909,966  $1,609,768  $38,600  $1,648,368 

 

16

 
  

Six Months Ended June 30, 2023

  

Six Months Ended June 30, 2022

 

Domestic: US

 

Dental

  

Medical

  

Grand Total

  

Dental

  

Medical

  

Grand Total

 

Instruments

 $495,683  $-  $495,683  $277,996  $-  $277,996 

Handpieces

  2,269,900   -   2,269,900   1,597,392   26,150   1,623,542 

Accessories

  44,320   -   44,320   47,481   -   47,481 

Grand Total

 $2,809,903  $-  $2,809,903  $1,922,869  $26,150  $1,949,019 
                         

International: Rest of World

                        

Instruments

 $873,205  $-  $873,205  $614,374  $-  $614,374 

Handpieces

  1,522,010   4,000   1,526,010   1,383,751   20,000   1,403,751 

Accessories

  28,446   -   28,446   22,162   -   22,162 

Grand Total

 $2,423,661  $4,000  $2,427,661  $2,020,287  $20,000  $2,040,287 

International: China

                        

Instruments

 $270,000  $-  $270,000  $-  $-  $- 

Handpieces

  -   -   -   359,964   -   359,964 

Accessories

  -   -   -   -   -   - 

Grand Total

 $270,000  $-  $270,000  $359,964  $-  $359,964 
                         

Total Product Sales

 $5,503,564  $4,000  $5,507,564  $4,303,120  $46,150  $4,349,270 

 

 

NOTE 9 – CONCENTRATIONS

 

Milestone Scientific has informal arrangements with third-party U.S. manufacturers of the STA devices, and epidural instruments pursuant to which they manufacture these products under specific purchase orders which contain advance requirements but without any long-term contract or minimum purchase commitment. Advances on contracts have been classified as current at  June 30, 2023, and 2022. The termination of the manufacturing relationship with any of these manufacturers could have a material adverse effect on Milestone Scientific’s ability to produce and sell its products. Although alternate sources of supply exist, and new manufacturing relationships could be established, Milestone Scientific would need to recover its existing tools or have new tools produced. Establishment of new manufacturing relationships could involve significant expense and delay. Any curtailment or interruption of the supply, because of termination of such a relationship, would have a material adverse effect on Milestone Scientific’s financial condition, business, and results of operations.

 

On January 3, 2023, the Company launched an E-Commerce platform, selling and shipping STA Single Tooth Anesthesia System® (STA) and handpieces directly to dental offices and dental groups within the U.S. For the three months ended June 30, 2023, E-Commerce accounted for 43% of net product sales and one distributor  accounted for 11% of net product sales. For the six months ended June 30, 2023, E-Commerce accounted for 42% of  net product sales. For the three months ended June 30, 2022, an aggregate of approximately 49% of the Company’s net sales were from one distributor. For the six months ended June 30, 2022, an aggregate of approximately 11% and 38% of the Company’s net product sales were from two distributors.

 

We had three distributors that accounted for 40%, 16% and 11% of accounts receivable, respectively for the six months ended June 30, 2023. We had two customers that accounted for 33%, and 20% amount of accounts receivable, respectively as of December 31, 2022. 

 

As of  June 30, 2023, we had one vendor that accounted for 45% of accounts payable and accounts payable related party. We had one vendor that accounted for 42% of accounts payable and accounts payable related party as of December 31, 2022.

 

17

 
 

NOTE 10 -- RELATED PARTY TRANSACTIONS

 

United Systems

 

Milestone Scientific has a supply  agreement with United Systems (whose controlling shareholder, Tom Cheng, is a significant stockholder of Milestone Scientific), the principal manufacturers of its handpieces, pursuant to which it manufactures products under specific purchase orders, but without minimum purchase commitments. Purchases from this manufacturer were approximately $592,000 and $1.3 million, respectively for the three and six months ended June 30, 2023. Purchases from this manufacturer were approximately $436,000 and $1.7 million, respectively for the three and six months ended June 30, 2022.

 

As of June 30, 2023 and December 31, 2022, Milestone Scientific owed this manufacturer approximately $592,000, and $819,000, respectively, which is included in accounts payable, related party and accrued expense, related party on the unaudited condensed consolidated balance sheets. 

 

Other

 

During 2022, K. Tucker Andersen, an significant stockholder of Milestone Scientific, entered into an agreement with Milestone Scientific to provide financial and business strategic services. Expenses recognized on this agreement were $25,000 and $50,000 for three and six months ended June 30, 2022. The agreement was not renewed in 2023.

 

The Director of Clinical Affairs’ royalty fee was approximately $144,000 and $267,000 for the three and six months ended June 30, 2023, respectively. The Director of Clinical Affairs’ royalty fee was approximately $81,000 and $213,000 for the three and six months ended June 30, 2022, respectively. Additionally, Milestone Scientific expensed consulting fees to the Director of Clinical Affairs of $39,000 and $78,000 for the three and six months ended June 30, 2023 and 2022, respectively.

 

As of  June 30, 2023 and December 31, 2022, Milestone Scientific owed the Director Clinical Affairs for royalties of approximately $145,000 and $120,000, respectively, which is included in accounts payable, related party and accrued expense, related party, in the condensed consolidated balance sheet.

 

Pursuant to a Succession Agreement dated April 6, 2021 between Mr. Osser and the Company: (i) the Employment Agreement dated as of July 10, 2017 between Mr. Osser and the Company, pursuant to which upon Mr. Osser stepping down as Interim Chief Executive Officer of the Company, the Company agreed to employ him as Managing Director, China Operations of the Company (the “China Operations Agreement”), and (ii) the Consulting Agreement dated as of July 10, 2017 (the “Consulting Agreement”) between the Company and U.S. Asian Consulting Group, LLC, a company of which Mr. Osser is a principal, the compensation under the China Operations Agreement was modified to reduce the overall compensation by $100,000 to $200,000, split equally between a cash amount and an amount in shares, and the compensation under the Consulting Agreement was increased by $100,000 to $200,000, equally split between a cash amount and an amount in shares, which shares were formerly payable under the China Operations Agreement.  Compensation under the China Operations Agreement and the Consulting Agreement are payable for 9.5 years from May 19, 2021. The Company recorded expense of $50,000 and $100,000 related to the Managing Director, China Operations for the three and six months ended June 30, 2023 and 2022, respectively. The Company recorded expense of $50,000 and $100,000 related to the US Asian Consulting Group, LLC for the three and six months ended June 30, 2023 and 2022, respectively.   

 

 

NOTE 11 — COMMITMENTS

 

(1)  Contract Manufacturing Agreement 

 

Milestone Scientific has informal arrangements with third-party manufacturers of the STA devices, and epidural instruments pursuant to which they manufacture these products under specific purchase orders but without any long-term contract or minimum purchase commitment. The Company has a purchase commitment for the delivery of 3,000 STA instruments as of June 30, 2023. As of June 30, 2023, the purchase order commitment was approximately $2.9 million, and approximately $1.2 million was paid and reported in advances on contracts in the condensed consolidated balance sheet. As of December 31, 2022, the purchase order commitment was approximately $1.7 million, and approximately $1.2 million was paid and reported in advances on contracts in the condensed consolidated balance sheet. The advances on contracts represent funding of future epidural instruments, and epidural replacements parts. The balance of the advances as of June 30, 2023 and December 31, 2022 is approximately $75,000, respectively. The advance is classified as current based on the estimated annual usage of the underlying inventory. 

 

18

 

(2)  Leases
 
Operating Leases

 

The Company identified and assessed the following significant assumptions in recognizing its right-of-use assets and corresponding lease liabilities:

 

 

As the Company’s leases do not provide an implicit rate, the Company estimated the incremental borrowing rate in calculating the present value of the lease payments. The Company has utilized its incremental borrowing rate based on the long-term borrowing costs of comparable companies in the Medical Device industry.

 

Since the Company elected to account for each lease component and its associated non-lease components as a single combined lease component, all contract consideration was allocated to the combined lease component.

 

The expected lease terms include non-cancellable lease periods. Renewal option periods are not included in the determination of the lease terms as they were not reasonably certain to be exercised.

 

The components of lease expense were as follows:

                %
  

Three months ended June 30,

  

Six months ended June 30,

 
  

2023

  

2022

  

2023

  

2022

 

Cash paid for operating lease liabilities

 $31,882  $31,999  $63,763  $63,881 

Cash paid for finance lease liabilities

  2,685   2,685   5,370   5,370 

Right-of-use assets obtained in exchange for new operating lease liabilities (1)

      663,009       663,009 

Property and equipment obtained in exchange for new finance lease liabilities

      43,242       43,242 

Weighted Average Remaining Lease Term

                

Finance leases (years)

             

1.5 years

 

Operating leases (years)

             

3.75 years

 

Weighted-average discount rate – operating leases

              9.20%

Weighted-average discount rate – finance leases

              9.20%
19

 

ITEM 7. Managements Discussion and Analysis of Financial Condition and Results of Operations

 

The following discussions of the financial condition and results of operations should be read in conjunction with the financial statements and the notes to those statements contained in this report and in connection with management's discussion and analysis and the audited consolidated financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2022, which was filed with the Securities and Exchange Commission, or SEC on March 30, 2023. Certain statements in this discussion and elsewhere in this report constitute forward-looking statements, within the meaning of section 21E of the Exchange Act, that involve risks and uncertainties. The actual results may differ materially from those anticipated in these forward-looking statements.

 

OVERVIEW

Milestone Scientific is a biomedical technology company that patents, designs, develops and commercializes innovative diagnostic and therapeutic injection technologies and devices for medical, dental and cosmetic use. Since our inception, we have engaged in pioneering proprietary, innovative, computer-controlled injection technologies, and solutions for the medical and dental markets. We believe our technologies are proven and well established. Our common stock was initially listed on the NYSE American on June 1, 2015, and trades under the symbol “MLSS”.

 

We have focused our resources on redefining the worldwide standard of care for injection techniques by making the experience more comfortable for the patient by reducing the anxiety and stress of receiving injections from the healthcare provider. Our computer-controlled injection devices make injections precise, efficient, and virtually painless.

 

Milestone Scientific has developed a proprietary, computer-controlled anesthetic delivery device, using The Wand®, a single use disposable handpiece. The device is marketed in dentistry under the trademark CompuDent®, and STA Single Tooth Anesthesia System® and is suitable for all dental procedures that require local anesthetic. Our proprietary DPS Dynamic Pressure Sensing technology® is our technology platform that advances the development of next-generation devices. It regulates flow rate and monitoring pressure from the tip of the needle, through platform extensions for local anesthesia for subcutaneous drug delivery, used in various dental and medical injections. It has specific medical applications for epidural space identification in regional anesthesia procedures and intra-articular joint injections.

Milestone Scientific remains focused on advancing efforts to achieve the following three primary objectives:

 

Establishing Milestone’s DPS Dynamic Pressure Sensing technology platform as the standard-of-care in painless and precise drug delivery, providing for the first time, objective visual and audible in-tissue pressure feedback, and continuing to expand platform applications;

Following obtaining successful FDA clearance of our first medical device, Milestone Scientific is transitioning from a research and development organization to a commercially focused medical device company; and

Expanding our global footprint of our CompuFlo Epidural and CathCheck System by utilizing a targeted field sales force and partnering with distribution companies worldwide.

 

Because of combining the ability to regulate the flow rate and monitor pressure at the tip of the needle, Milestone Scientific developed the industry’s first solution for painlessly administering an intra-ligamentary injection, i.e., “single-tooth anesthesia” which could be used as the only injection necessary for achieving dental anesthesia, foregoing the need to administer traditional injections such as a nerve branch block. In addition to single-tooth anesthesia, the STA System can effectively perform all the traditional injections that dentists routinely give but can provide them virtually pain free and with numerous clinical advantages. This device, which also utilizes a disposable handpiece, is currently marketed by Milestone Scientific as the STA Single Tooth Anesthesia  System. 

 

Our dental devices have been used to administer tens of millions of injections worldwide. Each of our devices has a related single use disposable handpiece, leading to a continuing revenue stream following sale of the device. At present, we sell disposable handpieces unique to our legacy product (the Wand and CompuDent) to users who have not upgraded to our current dental product, the STA Single Tooth Anesthesia System. Because of combining the ability to regulate the flow rate and monitor pressure at the tip of the needle, Milestone Scientific developed the industry’s first solution for painlessly administering an intra-ligamentary injection, i.e., “single-tooth anesthesia” which could be used as the only injection necessary for achieving dental anesthesia, foregoing the need to administer traditional injections such as a nerve branch block. In addition to single-tooth anesthesia, the STA System can effectively perform all the traditional injections that dentists routinely give but can provide them virtually pain free and with numerous clinical advantages. This device, which also utilizes a disposable handpiece, is currently marketed by Milestone Scientific as the STA Single Tooth Anesthesia  System

 

Building on the success of our proprietary, core technology platform for dental injections, and desiring to pursue other growth opportunities, we have recently begun to expand the uses and applications of our proprietary, patented technologies to achieve greater operational efficiencies, enhanced patient safety and therapeutic adherence, patient satisfaction, and improved quality of care across a broad range of medical specialties. In June 2017, we received FDA regulatory clearance to sell the CompuFlo Epidural Computer Controlled Anesthesia System in the United States for certain medical applications.

20

We intend to continue to expand the uses and applications of our DPS Dynamic Pressure Sensing technology. We believe that we and our technology solutions are recognized by key opinion leaders (i.e., academics, anesthesiologists and practicing dentists whose opinions are widely respected), industry experts and medical and dental practitioners as a leader in the emerging, computer-controlled injection industry.

 

The Single Tooth Anesthesia System (Dental)

 

Since its market introduction in early 2007, the STA Single Tooth Anesthesia System  and prior C-CLAD devices have been used to deliver over 90 million safe, effective, and comfortable injections. The instrument has also been favorably evaluated in numerous peer-reviewed, published clinical studies and associated articles. Moreover, there appears to be a growing consensus among users that the STA Instrument is proving to be a valuable and beneficial instrument that is positively impacting the practice of dentistry worldwide.

 

Medical Market Product

 

In June 2017, the FDA approved the CompuFlo Epidural System for epidural injections.

 

In May, 2022, the Company received a chronology-specific CPT Code for the  Company's technology by the American Medical Association, which marks an important milestone that could increase the potential number of anesthesia pain management clinics adopting the CompuFlo instrument. Effective  January 1, 2023 this temporary tracking code allows clinicians to submit claims to healthcare insurance providers using the Company’s technology for Epidural Sterile Injections in the lumbar, thoracic, cervical thoracic junctions of the spinal region, for reimbursement. A CPT code expands the potential for reimbursement of epidural procedures in pain management utilizing the CompuFlo Epidural System, which should help accelerate the commercial roll-out of CompuFlo in the United States.

 

On February  27, 2023, the Company  announced that its CompuFlo® Epidural System has received 510(k) FDA clearance for use in the thoracic region of the spine, including the cervical thoracic junction. This approval expands upon the Company’s prior approval of CompuFlo for use within the lumbar region of the spine, where the focus has been on labor and delivery.

 

   

Three Months Ended June 30, 2023

   

Three Months Ended June 30, 2022

 

Domestic: US

 

Dental

   

Medical

   

Grand Total

   

Dental

   

Medical

   

Grand Total

 

Instruments

  $ 271,215     $ -     $ 271,215     $ 155,028     $ -     $ 155,028  

Handpieces

    1,130,122       (2,200 )     1,127,922       801,533       18,600       820,133  

Accessories

    21,443       -       21,443       22,621       -       22,621  

Grand Total

  $ 1,422,780     $ (2,200 )   $ 1,420,580     $ 979,182     $ 18,600     $ 997,782  
                                                 

International: Rest of World

                                         

Instruments

  $ 474,250     $ -     $ 474,250     $ 160,814     $ -     $ 160,814  

Handpieces

    732,894       -       732,894       459,799       20,000       479,799  

Accessories

    12,242       -       12,242       9,973       -       9,973  

Grand Total

  $ 1,219,386     $ -     $ 1,219,386     $ 630,586     $ 20,000     $ 650,586  
                                                 

International: China 

                                           

Instruments

  $ 270,000     $ -     $ 270,000     $ -     $ -     $ -  

Handpieces

    -       -       -       -       -       -  

Accessories

    -       -       -       -       -       -  

Grand Total

  $ 270,000     $ -     $ 270,000     $ -     $ -     $ -  
                                                 

Total Product Sales

  $ 2,912,166     $ (2,200 )   $ 2,909,966     $ 1,609,768     $ 38,600     $ 1,648,368  

 

21

The following table shows a breakdown of Milestone Scientific’s product sales (net), domestically and internationally, by business segment product category: 

   

Six Months Ended June 30, 2023

   

Six Months Ended June 30, 2022

 

Domestic: US

 

Dental

   

Medical

   

Grand Total

   

Dental

   

Medical

   

Grand Total

 

Instruments

  $ 495,683     $ -     $ 495,683     $ 277,996     $ -     $ 277,996  

Handpieces

    2,269,900       -       2,269,900       1,597,392       26,150       1,623,542  

Accessories

    44,320       -       44,320       47,481       -       47,481  

Grand Total

  $ 2,809,903     $ -     $ 2,809,903     $ 1,922,869     $ 26,150     $ 1,949,019  
                                                 

International: Rest of World

                                               

Instruments

  $ 873,205     $ -     $ 873,205     $ 614,374     $ -     $ 614,374  

Handpieces

    1,522,010       4,000       1,526,010       1,383,751       20,000       1,403,751  

Accessories

    28,446       -       28,446       22,162       -       22,162  

Grand Total

  $ 2,423,661     $ 4,000     $ 2,427,661     $ 2,020,287     $ 20,000     $ 2,040,287  

International: China

                                               

Instruments

  $ 270,000     $ -     $ 270,000     $ -     $ -     $ -  

Handpieces

    -       -       -       359,964       -       359,964  

Accessories

    -       -       -       -       -       -  

Grand Total

  $ 270,000     $ -     $ 270,000     $ 359,964     $ -     $ 359,964  
                                                 

Total Product Sales

  $ 5,503,564     $ 4,000     $ 5,507,564     $ 4,303,120     $ 46,150     $ 4,349,270  

 

 

Current Product Platform

See  Note 1, “Organization and Business”.

 

Results of Operations

 

The following table sets forth the consolidated results of operations for the three and six months ended June 30, 2023 and 2022, respectively. The trends suggested by this table may not be indicative of future operating results:  

   

For the three months ended June 30, 2023

   

For the three months ended June 30, 2022

   

For the six months ended June 30, 2023

   

For the six months ended June 30, 2022

 

Operating results:

                               

Product sales, net

  $ 2,909,966     $ 1,648,368     $ 5,507,564     $ 4,349,270  

Cost of products sold

    1,019,907       967,720       1,728,882       1,986,196  

Gross profit

    1,890,059       680,648       3,778,682       2,363,074  
                                 

Operating expenses:

                               

Selling, general and administrative expenses

    3,937,281       3,282,322       7,011,012       6,397,948  

Research and development expenses

    213,647       266,560       353,994       731,027  

Depreciation and amortization expense

    16,681       16,645       33,902       33,460  

Total operating expenses

    4,167,609       3,565,527       7,398,908       7,162,435  

Loss from operations

    (2,277,550 )     (2,884,879 )     (3,620,226 )     (4,799,361 )

Other income, and interest expense net

    48,722       3,550       72,067       (1,193 )

Net loss

    (2,228,828 )     (2,881,329 )     (3,548,159 )     (4,800,554 )

Net loss attributable to noncontrolling interests

    (12,511 )     (22,848 )     (24,176 )     (40,350 )

Net loss attributable to Milestone Scientific Inc.

  $ (2,216,317 )   $ (2,858,481 )   $ (3,523,983 )   $ (4,760,204 )

 

22

 

Three months ended June 30, 2023 compared three months ended June 30, 2022

 

Net sales for 2023 and 2022 were as follows:

   

2023

   

2022

   

Change

 

Dental

  $ 2,912,166     $ 1,609,768     $ 1,302,398  

Medical

    (2,200 )     38,600     $ (40,800 )

Total sales, net

  $ 2,909,966     $ 1,648,368     $ 1,261,598  

 

Consolidated revenue for the three months ended June 30, 2023 and 2022 was approximately $2.9 million and $1.6 million, respectively, an increase of approximately $1.3 million. As of January 3, 2023, the Company launched an E-Commerce platform, to replace its previous U.S. distribution arrangement with Henry Schein selling and shipping the STA Single Tooth Anesthesia System® (STA) and handpieces directly to end users, including dental offices and dental groups, within the U.S. E-commerce revenue for the three months ended June 30, 2023 was approximately $1.2 million. The Company recorded no revenue from Henry Schein for the three months ended June 30, 2023 compared to approximately $811,000 recorded for the three months ended June 30, 2022.  Revenue from other U.S. distributors was approximately $214,000 for the three months ended June 30, 2023, an increase of $47,000 compared to June 30, 2022. For the three months ended June 30, 2023, international revenue was approximately $1.2 million, an increase of $588,000, compared to June 30, 2022. As of June 30, 2023 the Company, reported approximately $270,000 revenue from China, as compared to no revenue.
for the three months ended June 30, 2022.

 

Gross Profit for 2023 and 2022 were as follows:

   

2023

   

2022

   

Change

 

Dental

  $ 1,970,863     $ 1,083,603     $ 887,260  

Medical

    (80,804 )     (402,955 )   $ 322,151  

Total gross profit

  $ 1,890,059     $ 680,648     $ 1,209,411  

 

Consolidated gross profit for the three months ended June 30, 2023 increased by $1.2 million or 178% compared to the same period in 2022. The increase was due to higher margins sales associated with the launch of the  E-Commerce platform. The Company recorded approximately $91,000 for inventory that was obsolete and or expired.

 

Selling, general and administrative expenses for 2023 and 2022 were as follows: 

   

2023

   

2022

   

Change

 

Dental

  $ 1,166,645     $ 683,428     $ 483,217  

Medical

    772,810       1,181,009       (408,199 )

Corporate

    1,997,826       1,417,885       579,941  

Total selling, general and administrative expenses

  $ 3,937,281     $ 3,282,322     $ 654,959  

 

Consolidated selling, general and administrative expenses for the three months ended June 30, 2023, and 2022 were approximately $3.9 million and $3.3 million, respectively. The increase of approximately $655,000 is categorized in several areas. Employee salaries and benefits expenses increased approximately $148,000 for the three months ended June 30, 2023 compared to the same period in 2022. The Company increased quality control, regulatory, professional fees, and other selling, general and administrative expenses approximately $478,000. With the launch of the E-Commerce platform marketing and warehousing expense increased for the three months ended June 30, 2023, by approximately $58,000 compared to the same period in 2022. Royalty expenses increased approximately $63,000 for the three months ended June 30, 2023 compared to the same period in 2022. The Company decreased employee travel, by approximately $92,000 for the three months ended June 30, 2023, compared to the same period  in 2022.

 

Research and Development for 2023 and 2022 were as follows:

   

2023

   

2022

   

Change

 

Dental

  $ 204,057     $ 236,260     $ (32,203 )

Medical

    9,590       30,300       (20,710 )

Corporate

    -       -       -  

Total research and development

  $ 213,647     $ 266,560     $ (52,913 )

 

Consolidated research and development expenses for the three months ended June 30, 2023 and 2022 were approximately $214,000 and $267,000, respectively. The decrease of approximately $53,000 is related to the Company's progress in developing the next generation STA Single Tooth Anesthesia System.

23

Profit (Loss) from Operations for 2023 and 2022 were as follows:

   

2023

   

2022

   

Change

 

Dental

  $ 598,944     $ 163,022     $ 435,922  

Medical

    (863,899 )     (1,615,283 )     751,384  

Corporate

    (2,012,595 )     (1,432,618 )     (579,977 )

Total loss from operations

  $ (2,277,550 )   $ (2,884,879 )   $ 607,329  

 

The loss from operations was approximately $2.3 million and $2.9 million for the three months ended June 30, 2023 and 2022, respectively, a decrease of approximately $0.6 million. As stated above, the decrease in the loss from operations is driven by higher dental sales, which offsets the higher selling, general and administrative expenses during period.

 

Six months ended June 30, 2023 compared six months ended June 30, 2022

 

Net sales for 2023 and 2022 were as follows:

   

2023

   

2022

   

Change

 

Dental

  $ 5,503,564     $ 4,303,120     $ 1,200,444  

Medical

    4,000       46,150     $ (42,150 )

Total sales, net

  $ 5,507,564     $ 4,349,270     $ 1,158,294  

 

Consolidated revenue for the six months ended June 30, 2023 and 2022 was approximately $5.5 million and $4.3 million, respectively, an increase of approximately $1.2 million. As of January 3, 2023, the Company launched an E-Commerce  platform, selling and shipping the STA Single Tooth Anesthesia System® (STA) and handpieces directly to end users, including dental offices and dental groups, within the U.S. E-commerce's revenue for the six months ended June 30, 2023 was approximately $2.2 million. The Company terminated its major United States distributor, Henry Schein, as of December 31, 2022. The distributor had return rights through March 31, 2023 under the distribution contract. The Company recorded an allowance of approximately $179,000 for those returns at December 31, 2022. The allowance was reversed as of March 31, 2023. The Company recorded no revenue from Henry Schein for the six months ended June 30, 2023 compared to approximately $1.7 million recorded for the six months ended June 30, 2022.  Revenue from other U.S. distributors was approximately $432,000 for the six months ended June 30, 2023, an increase of $161,000 compared to June 30, 2022. For the six months ended June 30, 2023, international revenue was approximately $2.4 million, an increase of $403,000 compared to June 30, 2022. As of June 30,2023, the Company reported approximately $270,000 revenue from China,  a decrease of $90,000 compared to June 30, 2022.

 

Gross Profit for 2023 and 2022 were as follows:

   

2023

   

2022

   

Change

 

Dental

  $ 3,859,279     $ 2,761,265     $ 1,098,014  

Medical

    (80,597 )     (398,191 )   $ 317,594  

Total gross profit

  $ 3,778,682     $ 2,363,074     $ 1,415,608  

 

Consolidated gross profit for the six months ended June 30, 2023 increased by $1.4 million or 60 % compared to the same period in 2022. The increase was due to higher margins sales associated with our the launch of E-Commerce platform. The Company, recorded approximately $91,000 for inventory that was obsolete and or expired.

 

Selling, general and administrative expenses for 2023 and 2022 were as follows: 

   

2023

   

2022

   

Change

 

Dental

  $ 2,283,209     $ 1,549,441     $ 733,768  

Medical

    1,582,378       2,412,895       (830,517 )

Corporate

    3,145,425       2,435,612       709,813  

Total selling, general and administrative expenses

  $ 7,011,012     $ 6,397,948     $ 613,064  

 

Consolidated selling, general and administrative expenses for the six months ended June 30, 2023, and 2022 were approximately $7.0 million and $6.4 million, respectively. The increase of approximately $613,000 is categorized in several areas. Employee salaries and benefits expenses decreased approximately $19,000 for the six months ended June 30, 2023 compared to the same period in 2022. The Company increased quality control, regulatory, professional fees, and other selling, general and administrative expenses approximately $486,000. With the launch of the E-Commerce platform marketing and warehousing expense increased for the six months ended June 30, 2023, by approximately $213,000 compared to the same period in 2022. Royalty expenses increased approximately $53,000 for the six months ended June 30, 2023 compared to the same period in 2022. The Company decreased employee travel, by approximately $120,000 for the six months ended June 30, 2023, compared to the same period  in 2022.

 

24

 

Research and Development for 2023 and 2022 were as follows:

   

2023

   

2022

   

Change

 

Dental

  $ 332,800     $ 692,776     $ (359,976 )

Medical

    21,194       38,251       (17,057 )

Corporate

    -       -       -  

Total research and development

  $ 353,994     $ 731,027     $ (377,033 )

 

Consolidated research and development expenses for the six months ended June 30, 2023 and 2022 were approximately $354,000 and $731,000, respectively. The decrease of approximately $377,000 is related to the Company's progress in developing the next generation STA Single Tooth Anesthesia System.

 

Profit (Loss) from Operations for 2023 and 2022 were as follows:

Loss

 

2023

   

2022

   

Change

 

Dental

  $ 1,240,884     $ 517,262     $ 723,622  

Medical

    (1,685,832 )     (2,851,374 )     1,165,542  

Corporate

    (3,175,278 )     (2,465,249 )     (710,029 )

Total loss from operations

  $ (3,620,226 )   $ (4,799,361 )   $ 1,179,135  

 

The loss from operations was approximately $3.6 million and $4.8 million for the six months ended June 30, 2023 and 2022, respectively, a decrease of approximately $1.2 million. As stated above, the decrease in the loss from operations is driven by higher dental sales, which offset the higher selling, general and administrative expenses during period.

 

Liquidity and Capital Resources

 

Milestone Scientific has incurred annual operating losses and negative cash flows from operating activities since its inception. Milestone Scientific is actively pursuing the generation of positive cash flows from operating activities through an increase in revenue from its dental business and the medical business worldwide, and a reduction in operating expenses. On June 30, 2023, Milestone Scientific had cash and cash equivalents of approximately $3.7 million and working capital of approximately $7.4 million.  As of June 30, 2023, the Company held approximately $2.0 million in U.S. treasury securities with maturities within 3 and 6 months of the balance sheet date. For the six months ended June 30, 2023 and June 30, 2022, we had cash flows used in operating activities of approximately $3.0 million and $3.8 million, respectively. Management believes that the Company has sufficient cash, along with the current cash flow and support from the dental business to mitigate the expected selling expenditures for commercialization of the Epidural medical device, as well as other operating expenditures and planned new product development programs, over the next twelve months from the filing date of this report.

 

Item 3. Quantitative and Qualitative Disclosures about Market Risk

 

Milestone Scientific is a “smaller reporting company” as defined by Regulation S-K and, as such, is not required to provide the information required by this item.

 

Item 4. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

Milestone Scientific’s Chief Executive Officer and Chief Financial Officer have evaluated the effectiveness of the design and operation of Milestone Scientific’s disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this report. Based upon that evaluation, Milestone Scientific’s Chief Executive Officer and Chief Financial Officer have concluded that the disclosure controls and procedures as of June 30, 2023 are effective to ensure that information required to be disclosed in the reports Milestone Scientific files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to Milestone Scientific's management, including the Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosure.

 

Changes in Internal Control over Financial Reporting

 

There have been no changes in Milestone Scientific’s internal control over financial reporting that occurred during the quarter ended June 30, 2023 that have materially affected, or that are reasonably likely to materially affect, Milestone Scientific’s internal controls over financial reporting.

 

25

 

Item 1A. Risk Factors

 

There have been no material changes to the risk factors previously disclosed in Part I, Item 1A, of our 2022 Annual Report.

 

Item1B. Unresolved Staff Comments

 

None.

 

Item 2. Unregistered Sales of Equity Securities and use of proceeds

 

Not applicable.

 

Item 3. Default upon Senior Securities

 

Not applicable.

 

Item 4. Mine Safety Disclosure

 

Not applicable.

 

Item 5. Other Information

 

Not applicable.

 

26

 

Item 6. Exhibits and Financial Statement Schedules

 

Exhibit No

 

Description

     

31.1

 

Rule 13a-14(a) Certification-Chief Executive Officer*

31.2

 

Rule 13a-14(a) Certification-Chief Financial Officer*

32.1

 

Section 1350 Certifications-Chief Executive Officer**

32.2

 

Section 1350 Certifications-Chief Financial Officer**

101.INS

 

Inline XBRL Instance Document*

101.SCH

 

Inline XBRL Taxonomy Extension Schema Document*

101.CAL

 

Inline XBRL Taxonomy Extension Calculation Linkbase Document*

101.LAB

 

Inline XBRL Taxonomy Extension Label Linkbase Document*

101.PRE

 

Inline XBRL Taxonomy Extension Presentation Linkbase Document*

101.DEF

 

Inline XBRL Taxonomy Extension Definition Linkbase Document*

104

 

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

*

Filed herewith.

 

**

Furnished herewith and not filed, in accordance with item 601(32) (ii) of Regulation S-K.

 

27

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.

 

 

MILESTONE SCIENTIFIC INC.

 
     
 

/s/ Arjan Haverhals

 
 

Arjan Haverhals

 
 

Chief Executive Officer 

 
 

(Principal Executive Officer)

 
     
 

/s/ Peter Milligan

 
 

Peter Milligan

 
 

Chief Financial Officer 

 
 

(Principal Financial and Accounting Officer)

 

Date: August 14, 2023

   

 

 

28

Exhibit 31.1

 

 

 

Rule 13a-14(a)/15d-14(a) Certification

 

 

I, Arjan Haverhals, certify that:

 

1. I have reviewed this quarterly report on Form 10-Q of Milestone Scientific 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, considering 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, 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(s) 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)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under the 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 the 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 the 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(s) and I have disclosed, based on the 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 material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

 

Date: August 14, 2023

 

   

/s/ Arjan Haverhals

   

Arjan Haverhals

   

Chief Executive Officer

   

Principal Executive Officer

 

 

Exhibit 31.2

 

 

Rule 13a-14(a)/15d-14(a) Certification

 

I, Peter Milligan, certify that:

 

   1. I have reviewed this quarterly report on Form 10-Q of Milestone Scientific 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, considering 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, 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(s) 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)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under the 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 the 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 the 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(s) and I have disclosed, based on the 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 material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

 

Date: August 14, 2023

 

   

/s/ Peter Milligan

   

Peter Milligan

   

Chief Financial Officer

   

Principal Financial and Accounting Officer

 

 

 

Exhibit 32.1

 

 

 

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

 

 

In connection with the quarterly report of Milestone Scientific Inc. (“Milestone”) on Form 10-Q for the period ending June 30, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Arjan Haverhals  Chief Executive Officer of Milestone, certify, pursuant to 18 U.S.C. ss. 1350, as adopted pursuant to ss. 906 of the Sarbanes-Oxley Act of 2002, that:

 

(1) The Report fully complies with the requirements of section 13(a) or 15(d) 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 result of operations of Milestone.

 

Date August 14, 2023

 

 

/s/ Arjan Haverhals

Arjan Haverhals

Chief Executive Officer

Principal Financial Officer

A signed original of this certification has been provided to Milestone and will be retained by Milestone and furnished to the Securities and Exchange Commission or its staff upon request.

 

 

 

 

Exhibit 32.2

 

 

 

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

 

 

In connection with the quarterly report of Milestone Scientific Inc. (“Milestone”) on Form 10-Q for the period ending June 30, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Peter Milligan Chief Financial Officer of Milestone, certify, pursuant to 18 U.S.C. ss. 1350, as adopted pursuant to ss. 906 of the Sarbanes-Oxley Act of 2002, that:

 

(1) The Report fully complies with the requirements of section 13(a) or 15(d) 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 result of operations of Milestone.

 

Date August 14, 2023

 

/s/ Peter Milligan

Peter Milligan

Chief Financial Officer

 

A signed original of this certification has been provided to Milestone and will be retained by Milestone and furnished to the Securities and Exchange Commission or its staff upon request.

 

 

 
v3.23.2
Document And Entity Information - shares
6 Months Ended
Jun. 30, 2023
Aug. 14, 2023
Document Information [Line Items]    
Entity Central Index Key 0000855683  
Entity Registrant Name MILESTONE SCIENTIFIC INC.  
Amendment Flag false  
Current Fiscal Year End Date --12-31  
Document Fiscal Period Focus Q2  
Document Fiscal Year Focus 2023  
Document Type 10-Q  
Document Quarterly Report true  
Document Period End Date Jun. 30, 2023  
Document Transition Report false  
Entity File Number 001-14053  
Entity Incorporation, State or Country Code DE  
Entity Tax Identification Number 13-3545623  
Entity Address, Address Line One 425 Eagle Rock Avenue Suite 403  
Entity Address, City or Town Roseland  
Entity Address, State or Province NJ  
Entity Address, Postal Zip Code 07068  
City Area Code 973  
Local Phone Number 535-2717  
Title of 12(b) Security Common Stock, par value $.001 per share  
Security Exchange Name NYSEAMER  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   71,365,659
No Trading Symbol Flag true  
v3.23.2
Condensed Consolidated Balance Sheets (Current Period Unaudited) - USD ($)
Jun. 30, 2023
Dec. 31, 2022
Current assets:    
Cash and cash equivalents $ 3,701,453 $ 8,715,279
Marketable securities 1,981,180 0
Accounts receivable, net 789,584 693,717
Prepaid expenses and other current assets 551,990 443,872
Inventories 2,193,063 1,792,335
Advances on contracts 1,282,806 1,325,301
Total current assets 10,500,076 12,970,504
Furniture, fixtures and equipment, net 11,867 18,146
Intangibles, net 201,529 227,956
Right of use assets finance lease 13,319 17,645
Right of use assets operating lease 400,511 443,685
Other assets 24,150 24,150
Total assets 11,151,452 13,702,086
Current liabilities:    
Accrued expenses and other payables 1,422,506 1,124,839
Accrued expenses, related party 278,339 167,549
Current portion of finance lease liabilities 9,805 9,365
Current portion of operating lease liabilities 97,429 91,701
Total current liabilities 3,109,356 3,299,675
Non-current portion of finance lease liabilities 5,683 10,698
Non-current portion of operating lease liabilities 334,750 385,279
Total liabilities 3,449,789 3,695,652
Commitments
Stockholders’ equity    
Common stock, par value $.001;authorized 100,000,000 shares; 70,107,739 shares issued and 70,074,406 shares outstanding as of June 30, 2023; 69,306,497 shares issued and 69,273,164 shares outstanding as of December 31, 2022; 70,108 69,306
Additional paid in capital 128,720,911 127,478,325
Accumulated deficit (119,934,388) (116,410,405)
Treasury stock, at cost, 33,333 shares (911,516) (911,516)
Total Milestone Scientific, Inc. stockholders' equity 7,945,115 10,225,710
Noncontrolling interest (243,452) (219,276)
Total stockholders’ equity 7,701,663 10,006,434
Total liabilities and stockholders’ equity 11,151,452 13,702,086
Nonrelated Party [Member]    
Current liabilities:    
Accounts payable 674,587 1,102,729
Related Party [Member]    
Current liabilities:    
Accounts payable $ 626,690 $ 803,492
v3.23.2
Condensed Consolidated Balance Sheets (Current Period Unaudited) (Parentheticals) - $ / shares
Jun. 30, 2023
Dec. 31, 2022
Common stock, par value (in dollars per share) $ 0.001 $ 0.001
Common stock, shares authorized (in shares) 100,000,000 100,000,000
Common stock, shares issued (in shares) 70,107,739 69,306,497
Common stock, shares outstanding (in shares) 70,074,406 69,273,164
Treasury stock, shares (in shares) 33,333 33,333
v3.23.2
Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Product sales, net $ 2,909,966 $ 1,648,368 $ 5,507,564 $ 4,349,270
Cost of products sold 1,019,907 967,720 1,728,882 1,986,196
Gross profit 1,890,059 680,648 3,778,682 2,363,074
Selling, general and administrative expenses 3,937,281 3,282,322 7,011,012 6,397,948
Research and development expenses 213,647 266,560 353,994 731,027
Depreciation and amortization expense 16,681 16,645 33,902 33,460
Total operating expenses 4,167,609 3,565,527 7,398,908 7,162,435
Loss from operations (2,277,550) (2,884,879) (3,620,226) (4,799,361)
Interest income (expense) 48,722 3,550 72,067 (1,193)
Loss before provision for income taxes (2,228,828) (2,881,329) (3,548,159) (4,800,554)
Net loss (2,228,828) (2,881,329) (3,548,159) (4,800,554)
Net loss attributable to noncontrolling interests (12,511) (22,848) (24,176) (40,350)
Net loss attributable to Milestone Scientific Inc. $ (2,216,317) $ (2,858,481) $ (3,523,983) $ (4,760,204)
Net loss per share applicable to common stockholders—        
Basic and Diluted (in dollars per share) $ (0.03) $ (0.04) $ (0.05) $ (0.07)
Weighted average shares outstanding and to be issued—        
Basic and Diluted (in shares) 72,333,656 70,356,796 72,048,223 70,585,590
v3.23.2
Condensed Consolidated Statements of Changes in Stockholders' Equity (Unaudited) - USD ($)
Board of Directors [Member]
Common Stock [Member]
Board of Directors [Member]
Additional Paid-in Capital [Member]
Board of Directors [Member]
Retained Earnings [Member]
Board of Directors [Member]
Noncontrolling Interest [Member]
Board of Directors [Member]
Treasury Stock, Common [Member]
Board of Directors [Member]
Consultant [Member]
Common Stock [Member]
Consultant [Member]
Additional Paid-in Capital [Member]
Consultant [Member]
Retained Earnings [Member]
Consultant [Member]
Noncontrolling Interest [Member]
Consultant [Member]
Treasury Stock, Common [Member]
Consultant [Member]
Common Stock [Member]
Additional Paid-in Capital [Member]
Retained Earnings [Member]
Noncontrolling Interest [Member]
Treasury Stock, Common [Member]
Total
Balance (in shares) at Dec. 31, 2021                         68,153,336          
Balance at Dec. 31, 2021                         $ 68,153 $ 124,915,560 $ (107,704,274) $ (152,541) $ (911,516) $ 16,215,382
Stock based compensation                         $ 0 305,370 0 0   305,370
Common stock to be issued to employees for bonuses                           164,385       164,385
Net loss                             (1,901,723) (17,502)   (1,919,225)
Balance (in shares) at Mar. 31, 2022                         68,153,336          
Balance at Mar. 31, 2022                         $ 68,153 125,385,315 (109,605,997) (170,043) (911,516) 14,765,912
Balance (in shares) at Dec. 31, 2021                         68,153,336          
Balance at Dec. 31, 2021                         $ 68,153 124,915,560 (107,704,274) (152,541) (911,516) 16,215,382
Net loss                                   (4,800,554)
Balance (in shares) at Jun. 30, 2022                         68,811,482          
Balance at Jun. 30, 2022                         $ 68,811 126,175,735 (112,464,478) (192,891) (911,516) 12,675,661
Balance (in shares) at Mar. 31, 2022                         68,153,336          
Balance at Mar. 31, 2022                         $ 68,153 125,385,315 (109,605,997) (170,043) (911,516) 14,765,912
Stock based compensation                         $ 0 392,266 0 0 0 392,266
Common stock issued for services (in shares)                         12,879          
Common stock issued for services                         $ 13 12,864 0 0 0 12,877
Common stock to be issued to employees for bonuses                         147 (147) 0 0 0 0
Net loss                         $ 0 0 (2,858,481) (22,848) 0 (2,881,329)
Common stock to be issued for payment of consulting services (in shares)                         246,028          
Common stock to be issued for payment of consulting services                         $ 246 345,689 0 0 0 345,935
Common stock issued to employee for compensation (in shares) 224,850                       27,051          
Common stock issued to employee for compensation $ 225 $ (225) $ 0 $ 0 $ 0 $ 0             $ 27 39,973 0 0 0 40,000
Common stock to be issued to employees for bonuses (in shares)                         147,338          
Balance (in shares) at Jun. 30, 2022                         68,811,482          
Balance at Jun. 30, 2022                         $ 68,811 126,175,735 (112,464,478) (192,891) (911,516) 12,675,661
Balance (in shares) at Dec. 31, 2022                         69,306,497          
Balance at Dec. 31, 2022                         $ 69,306 127,478,325 (116,410,405) (219,276) (911,516) 10,006,434
Stock based compensation                         $ 0 388,772 0 0   388,772
Common stock issued for services (in shares) 256,868           242,335                      
Common stock issued for services $ 258 $ (258) $ 0     $ 0 $ 242 $ 125,758 $ 0 $ 0 $ 0 $ 126,000            
Common stock to be issued to employees for bonuses                           50,000       50,000
Net loss                             (1,307,666) (11,665)   (1,319,331)
Balance (in shares) at Mar. 31, 2023                         69,805,700          
Balance at Mar. 31, 2023                         $ 69,806 128,042,597 (117,718,071) (230,941) (911,516) 9,251,875
Balance (in shares) at Dec. 31, 2022                         69,306,497          
Balance at Dec. 31, 2022                         $ 69,306 127,478,325 (116,410,405) (219,276) (911,516) 10,006,434
Net loss                                   (3,548,159)
Balance (in shares) at Jun. 30, 2023                         70,107,739          
Balance at Jun. 30, 2023                         $ 70,108 128,720,911 (119,934,388) (243,452) (911,516) 7,701,663
Balance (in shares) at Mar. 31, 2023                         69,805,700          
Balance at Mar. 31, 2023                         $ 69,806 128,042,597 (117,718,071) (230,941) (911,516) 9,251,875
Stock based compensation                         $ 0 404,330       404,330
Common stock issued for services (in shares)                         192,835          
Common stock issued for services                         $ 193 (193) 0 0 0 0
Common stock to be issued to employees for bonuses                         0 217,500 0 0 0 217,500
Net loss                         $ 0   (2,216,317) (12,511) 0 (2,228,828)
Common stock to be issued for payment of consulting services (in shares)                         109,204          
Common stock to be issued for payment of consulting services                         $ 109 56,677 0 0 0 56,786
Balance (in shares) at Jun. 30, 2023                         70,107,739          
Balance at Jun. 30, 2023                         $ 70,108 $ 128,720,911 $ (119,934,388) $ (243,452) $ (911,516) $ 7,701,663
v3.23.2
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Cash flows from operating activities:    
Net loss $ (3,548,159) $ (4,800,554)
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation expense 7,473 6,692
Amortization of intangibles 26,429 26,768
Stock based compensation 793,101 697,635
Inventory Reserve 0 430,245
Employees paid in stock 267,500 217,262
Expense paid in stock 182,786 345,935
Amortization of right-of-use asset 45,624 43,491
Changes in operating assets and liabilities:    
Increase in accounts receivable (95,867) 117,926
Increase in accounts receivable, related party 0 (269,973)
(Decrease) in inventories (400,728) (394,167)
(Decrease) increase in advances on contracts 42,495 (321,597)
Increase in prepaid expenses and other current assets (108,118) (147,578)
(Decrease) increase in accounts payable (428,141) 604,976
(Decrease) increase in accounts payable, related party (176,803) 337,801
Increase (decrease) in accrued expenses 297,666 (464,800)
Increase (decrease) in accrued expenses, related party 110,790 (191,789)
Decrease operating right of use lease asset (43,174) (39,338)
Net cash used in operating activities (3,027,126) (3,801,065)
Cash flows from investing activities:    
Purchase of furniture, fixtures, and equipment (1,196) 85
Purchase of Marketable securities (1,981,180) 0
Net cash (used in) provided by investing activities (1,982,376) 85
Cash flows from financing activities:    
Payments finance lease obligations (4,324) (4,234)
Net cash used in financing activities (4,324) (4,234)
Net decrease in cash and cash equivalents (5,013,826) (3,805,214)
Cash and cash equivalents at beginning of period 8,715,279 14,764,346
Cash and cash equivalents at end of period $ 3,701,453 $ 10,959,132
v3.23.2
Note 1 - Organization and Business
6 Months Ended
Jun. 30, 2023
Notes to Financial Statements  
Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block]

NOTE 1 ORGANIZATION AND BUSINESS

 

All references in this report to “Milestone Scientific,” “us,” “our,” “we,” the “Company” or “Milestone” refer to Milestone Scientific Inc., and its consolidated subsidiaries, Wand Dental, Inc., and Milestone Medical, Inc. (all described below), unless the context otherwise indicates. Milestone Scientific is the owner of the following registered U.S. trademarks: CompuDent®; CompuFlo®; DPS Dynamic Pressure Sensing technology®; Milestone Scientific ®; CathCheck®; the Milestone logo ®; SafetyWand®; STA Single Tooth Anesthesia System®; and The Wand ®. 

 

Milestone Scientific was incorporated in the State of Delaware in August 1989. Milestone Scientific has developed a proprietary, revolutionary, computer-controlled anesthetic delivery device, its DPS Dynamic Pressure Sensing Technology® System, to meet the needs of various subcutaneous drug delivery injections and fluid aspiration – enabling healthcare practitioners to achieve multiple unique benefits that cannot currently be accomplished with the 160-year-old manual syringe. The device, using The Wand®, a single use disposable handpiece, is marketed in dentistry under the trademarks CompuDent® and STA Single Tooth Anesthesia System®, and is suitable for all dental procedures that require local anesthetic. The dental devices are sold in the United States, Canada and in 38 other countries. Milestone Scientific also has 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) on the CompuFlo® Epidural Computer Controlled Anesthesia System in the lumbar thoracic and cervical thoracic junction of the spinal region. In addition, certain medical devices have obtained CE mark approval and can be marketed and sold in most European countries.

 

Milestone Scientific is a biomedical technology company that patents, designs, develops and commercializes innovative diagnostic and therapeutic injection technologies and devices for medical and dental use. Since our inception, we have engaged in pioneering proprietary, innovative, computer-controlled injection technologies, and solutions for the medical and dental markets. Our common stock was initially listed on the NYSE American on June 1, 2015 and trades under the symbol “MLSS”. The Company is focused on building its intellectual property portfolio across numerous indications.

v3.23.2
Note 2- Liquidity and Uncertainties
6 Months Ended
Jun. 30, 2023
Notes to Financial Statements  
Substantial Doubt about Going Concern [Text Block]

NOTE 2-  LIQUIDITY  AND UNCERTAINTIES    

 

The Company has evaluated whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company's ability to continue as a going concern within one year after the date that the unaudited condensed consolidated financial statements are issued. Total losses since inception have been $120 million. The operating losses were $2.3 million and $3.6 million for three and six months ended June 30, 2023, respectively. Management has prepared cash flow forecasts covering a period of 12 months from the date of issuance of these financial statements. As a result of the forecast, management believes that the Company has sufficient cash, along with the current cash flow and support from the dental business to mitigate the expected selling expenditures for commercialization of the Epidural medical device, as well as other operating expenditures and planned new product development programs, over the next twelve months from the filing date of this report, and thus has concluded that there is no substantial doubt about the Company’s ability to continue as a going concern. 

 

These forecasts include several revenue and operating expense assumptions which indicate that the Company’s current cash and liquidity is sufficient to finance the operating requirements for at least the next twelve months. Management believes that the Company will have sufficient cash reserves to meet its anticipated obligations for at least the next twelve months from the filing date of this report. Milestone Scientific is actively pursuing the generation of positive cash flows from operating activities through an increase in revenue from its dental business worldwide, the generation of revenue from its medical devices and disposables business in the United States and worldwide, and a reduction in operating expenses. However, the Company’s continued operations will depend on its ability to raise additional capital through various potential sources until it achieves profitability, if ever.

 

In addition to its employees, the Company relies on (i) distributors, agents, and third-party logistics providers in connection with product sales and distribution, and (ii) raw material and component suppliers in the U.S., Europe, and China. If the Company, or any of these entities, encounter any disruptions to its or their respective operations or facilities, or if the Company or any of these third-party partners were to shut down for any reason, including by fire, natural disaster, such as a hurricane, tornado or severe storm, power outage, systems failure, labor dispute, pandemic or other public health crises, or other unforeseen disruption, then the Company or they may be prevented or delayed from effectively operating its or their business, respectively.

 

Sanctions imposed by the United States and other western democracies, against Russia because of the Ukraine conflict, and any expansion of the conflict, have had and are likely to continue to have unpredictable and wide-ranging effects on the domestic and global economy and financial markets, which could have an adverse effect on our business and results of operations. The conflict has caused market volatility, a sharp increase in certain commodity prices, and an increasing number and frequency of cybersecurity threats. As direct impact from the conflict, we have experienced a decrease in international sales to Ukraine and halted all sales to Russia. We will continue to monitor the situation carefully and, if necessary, take action to protect our business, operations, and financial condition.

 

v3.23.2
Note 3 - Summary of Significant Accounting Policies
6 Months Ended
Jun. 30, 2023
Notes to Financial Statements  
Significant Accounting Policies [Text Block]

NOTE 3 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

1.  Principles of Consolidation

 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States ("GAAP") and the applicable rules and regulations of the Securities and Exchange Commission (SEC), and include the accounts of Milestone Scientific and its wholly owned and majority owned subsidiaries, including, Wand Dental (wholly owned), and Milestone Medical (majority owned).  All significant, intra-entity transactions and balances have been eliminated in the consolidation.

 

2. Basis of Presentation

 

The unaudited condensed consolidated financial statements of Milestone Scientific have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) for interim financial information with the instructions for Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete annual financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements contain all adjustments (consisting of normal recurring entries) necessary to fairly present such interim results. Interim results are not necessarily indicative of the results of operations which may be expected for a full year or any subsequent period. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto for the year ended December 31, 2022, included in Milestone Scientific's Annual Report on Form 10-K.

 

3. Use of Estimates

 

The preparation of unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions in determining the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. The most significant estimates relate to the allowance for doubtful accounts, inventory valuation, cash flow assumptions regarding evaluations of going concern considerations, stock compensation expense, and valuation allowances on deferred tax assets. Actual results could differ from those estimates.

 

4.  Revenue Recognition

 

The Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To perform revenue recognition, the Company performs the following five steps:

 

i.

identification of the promised goods or services in the contract;

ii.

determination of whether the promised goods or services are performance obligations including whether they are distinct

in the context of the contract;        

iii.

measurement of the transaction price, including the constraint on variable consideration;

iv.

allocation of the transaction price to the performance obligations based on estimated selling prices; and

v.

recognition of revenue when (or as) the Company satisfies each performance obligation. A performance obligation is a

promise in a contract to transfer a distinct good or service to the customer and is the unit of account in ASC 606.

 

The Company derives its revenues from the sale of its products, primarily dental instruments, handpieces, and other related products. The Company sells its products directly to consumers in the United States and through a global distribution network that includes both exclusive and non-exclusive distribution agreements with related and third parties.

 

Revenue from product sales is recognized upon transfer of control of a product to a customer, generally upon date of shipment. The Company has no obligation on product sales for any installation, set-up, or maintenance, these being the responsibility of the buyer. Milestone Scientific's only obligation after sale is the normal commercial warranty against manufacturing defects if the alleged defective unit is returned within the warranty period. 

 

E-Commerce

 

As of January 3, 2023, the Company launched an E-Commerce platform, selling and shipping STA Single Tooth Anesthesia Systems® (STA) and handpieces directly to dental offices and dental groups within the United States. Our  E-commerce portal accepts online payments via credit and debit cards. The cost of delivery is charged to customer along with appropriate sales tax. The Company recognizes revenue from product sales at the time the product ships to a customer via a third party. 

 

Sales Returns

 

The Company records allowances for product returns as a reduction of revenue at the time product sales are recorded. Several factors are considered in determining whether an allowance for product returns is required, including the customers’ return rights and the Company’s historical experience with returns and the amount of product in the distribution channel not consumed by end users and subject to return. The Company relies on historical return rates to estimate returns.

 

The Company terminated its major U.S. distributor contract as of December 31, 2022. That distributor had return rights in connection with this contract termination that extended through March 31, 2023. The Company recorded allowance of approximately $179,000 for those returns within its December 31, 2022 financial statements. No returns have been  presented, and the Company reversed the allowance for sales returns.

 

Financing and Payment

 

The Company's payment terms differ by geography and customer, but payments from distributors are required within 90 days or less from the date of shipment. The E-commerce portal sells directly to end users and accepts online payments via credit and debit cards via a third-party. These payments from the third-party are settled within two business days.

 

Disaggregation of Revenue

 

The Company operates in two operating segments: dental and medical. Therefore, results of the Company's operations are reported on a consolidated basis for purposes of segment reporting, consistent with internal management reporting. See Note 8 for revenues by geographical market, based on the customer’s location, and product category for the three and six months ended June 30, 2023 and 2022.

 

5.  Cash and Cash Equivalents

 

Milestone Scientific considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. As of June 30, 2023 and December 31, 2022, Milestone Scientific has approximately $3.7 million and $8.7 million, respectively of cash and cash equivalents. As of June 30, 2023 and December 31, 2022, Milestone Scientific had approximately $3.4 million and $8.3 million, respectively, in cash, cash equivalents, and marketable securities in accounts that exceeded the Federal Deposit Insurance Corporation insurance limit of $250,000.

 

6. Marketable Securities

 

The Company’s marketable securities are comprised of treasury bills with original maturity greater than three months from date of purchase. The Company’s marketable securities are measured at fair value and are accounted for in accordance with ASU 2016-01. Unrealized holding gains and losses on treasury bills are recorded in net realized and unrealized gain (loss) from investments on the unaudited condensed consolidated statements of operations. Dividend and interest income are recognized when earned. Realized gains and losses are included in earnings and are derived using the specific identification method for determining the cost of the marketable securities.

 

The appropriate classification of marketable securities is determined at the time of purchase and evaluated as of each reporting balance sheet date. Investments in marketable debt and equity securities classified as available-for-sale are reported at fair value. Fair value is determined using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or liabilities or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Declines in the fair values of equity securities that are considered other-than-temporary, are charged to other income (expense), net. The Company considers available evidence in evaluating potential impairments of its investments, including the duration and extent to which fair value is less than cost. As of  June 30, 2023, the Company held approximately $2.0 million in  U.S. treasury securities, with  maturity dates within 3 and 6 months of the balance sheet date.

 

7.  Accounts Receivable

 

The e-commerce portal sells directly to end users and accepts online payments via credit and debit cards via a third-party credit card processor. These payments are settled within 2 business days of the transactions. Sales to distributors are on credit terms. The Company estimates losses from the ability or inability of its distributor to make payments on amounts billed.

 

Distributors credit sales are due in 90 days or less from the date of invoicing. As of June 30, 2023 and  December 31, 2022, accounts receivable was recorded, net of allowance for doubtful accounts of $27,000 and $10,000, respectively.

 

8.  Inventories

 

Inventories principally consist of finished goods and component parts stated at the lower of cost (first-in, first-out method) or net realizable value. Inventory quantities on hand are reviewed on a quarterly basis and a provision for excess, slow moving, defective, and obsolete inventory is recorded if required based on past and expected future sales, potential technological obsolescence, and product expiration requirements.

 

The valuation allowance creates a new cost basis for the inventory, and it is not subsequently marked up through a reduction in the valuation allowance based on any changes in the underlying facts and circumstances. When the valuation allowance is initially recorded, the increase to the allowance is recognized as an increase in cost of sales. The valuation allowance is only reduced if or when the underlying inventory is sold or destroyed, at which time cost of sales recognized would include the previous adjusted cost basis.

 

9.  Basic and Diluted Net Loss Per Common Share

 

Milestone Scientific presents “basic” earnings (loss) per common share applicable to common stockholders and, if applicable, “diluted” earnings (loss) per common share applicable to common stockholders pursuant to the provisions of ASC 260, “Earnings per Share”. Basic earnings (loss) per common share is calculated by dividing net income or loss applicable to common stockholders by the weighted average number of common shares outstanding and to be issued common shares as follows: 72,333,656 and 70,356,796 for the three months ended June 30, 2023 and 2022, respectively; and 72,048,223 and 70,585,590 for the six months ended June 30, 2023 and 2022, respectively. The calculation of diluted earnings per common share is like that of basic earnings per common share, except that the denominator is increased to include the number of additional common shares that would have been outstanding if all potentially dilutive common shares, such as those issuable upon the exercise of stock options and warrants were issued during the period.

 

Since Milestone Scientific had net losses in the six months ended June 30, 2023 and 2022, the assumed effects of the exercise of potentially dilutive outstanding stock options, unissued restricted stock awards (“RSA”) and warrants, were not included in the calculation as their effect would have been anti-dilutive. Such outstanding options, RSA's and warrants totaled  4,142,155 and 8,166,380 for the six months ended on June 30, 2023 and  2022, respectively.

 

10. Stock-Based Compensation 
 

Milestone Scientific accounts for stock-based compensation under ASC Topic 718, Share-Based Payment. ASC Topic 718 requires all share-based payments to employees, non-employees, directors, and officers, including grants of employee stock options, to be recognized in the unaudited condensed consolidated statements of operations over the service period, as an operating expense, based on the grant-date fair values.

 

11.  Recent Accounting Pronouncements

 

In June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which amends the guidance on measuring credit losses for certain financial assets measured at amortized cost, including trade receivables. The FASB has subsequently issued several updates to the standard, providing additional guidance on certain topics covered by the standard. This update requires entities to recognize an allowance for credit losses using a forward-looking expected loss impairment model, taking into consideration historical experience, current conditions, and supportable forecasts that impact collectability.

 

In November 2019, the FASB issued ASU 2019-10, Financial Instruments - Credit Losses (Topic, 326), Derivatives and hedging (Topic 815), and Leases (Topic 842): Effective dates, which deferred the effective date of ASU 2016-13 for the Company. As a result of ASU 2019-10, ASU 2016-13 is effective for all entities with fiscal years beginning after December 15, 2022, including interim periods.  As January 1, 2023, the Company adopted  ASU 2019-10, Financial Instruments - Credit Losses (Topic, 326), Derivatives and hedging (Topic 815), and Leases (Topic 842) the adoption of this ASU does not have a material impact on our financial statements.

 

v3.23.2
Note 4 - Inventories
6 Months Ended
Jun. 30, 2023
Notes to Financial Statements  
Inventory Disclosure [Text Block]

NOTE 4 — INVENTORIES

 

Inventories consist of the following:

  

June 30, 2023

  

December 31, 2022

 
         

Dental finished goods

 $1,833,864  $1,315,263 

Medical finished goods

  208,081   334,124 

Component parts and other materials

  151,118   142,948 

Total inventories

 $2,193,063  $1,792,335 

 

The Company has recorded an allowance on slow moving Medical finished goods due to the slow adoption of the epidural instruments and handpieces for approximately $1.1 million and $1.0 million  as of June 30, 2023 and December 31, 2022, respectively.

v3.23.2
Note 5 - Advances on Contracts
6 Months Ended
Jun. 30, 2023
Notes to Financial Statements  
Advances to Contract Manufacturer [Text Block]

NOTE 5 — ADVANCES ON CONTRACTS

 

The advances on contracts represent funding of future STA devices, epidural instruments, and epidural replacements parts. The balance of the advances as of June 30, 2023 and December 31, 2022 is approximately $1.3 million, respectively. The advance is classified as current based on the estimated annual usage of the underlying inventory.  

v3.23.2
Note 6 - Stockholders' Equity
6 Months Ended
Jun. 30, 2023
Notes to Financial Statements  
Equity [Text Block]

NOTE 6 STOCKHOLDERS EQUITY

 

Warrants

 

The following table summarizes information about shares issuable under warrants outstanding as of June 30, 2023:

  

Warrant shares outstanding

  

Weighted Average exercise price

  

Weighted Average remaining life

  

Intrinsic value

 
                 

Outstanding at January 1, 2023

  4,268,221   2.18   0.50   - 

Issued

  -   -   -   - 

Exercised

  -   -   -   - 

Expired or cancelled

  (3,953,649)  -   -   - 

Outstanding and exercisable at June 30, 2023

  314,572   0.50   0.60   116,549 

 

Shares to Be Issued

 

As of June 30, 2023 and 2022, there were 2,380,068 and 1,852,789 respectively of shares to be issued whose issuance has been deferred under the terms of employment agreements with the Chief Executive Officer, and other employees of Milestone Scientific. Such shares will be issued to each party upon termination of their employment.

 

As of June 30, 2023and 2022, there were 382,697 and 174,364 respectively of  shares to be issued to non-employees,  for services rendered. The number of shares was fixed at the date of grant and were fully vested upon grant date.

 

The following table summarizes information about shares to be issued on June 30, 2023 and 2022.

  

June 30, 2023

  

June 30, 2022

 
         

Shares-to-be-issued, outstanding January 1, 2023 and 2022, respectively

  2,440,673   2,066,343 

Granted in current period

  322,092   108,148 

Issued in current period

  -   (147,338)

Shares-to be issued outstanding June 30, 2023 and 2022, respectively

  2,762,765   2,027,153 

 

Stock Options Plans

 

The Milestone Scientific Inc. 2020 Equity Compensation Plan, as amended and restated (the "2020 Plan"), provides for awards of restricted common stock, restricted stock units, options to purchase common stock and other awards, up to a maximum 11,500,000 shares of common stock and expires in June 2031. Options may be granted to employees, directors, and consultants of Milestone Scientific for the purchase of shares of common stock at a price not less than the fair market value of common stock on the date of grant. In general, options become exercisable over a three-year period from the grant date and expire five years after the date of grant.

 

Milestone Scientific recognizes compensation expense over the requisite service period. For three and six months ended June 30, 2023 Milestone Scientific recognized approximately $229,000 and $457,000 of total employee compensation cost, respectively, recorded in general and administrative expenses on the statement of operations. For three and six months ended June 30, 2022 Milestone Scientific recognized $223,000 and $501,000 of total employee compensation cost, respectively, recorded in general and administrative expenses on the statement of operations.

 

A summary of option activity for employees under the plans and changes during the six months ended June 30, 2023 is presented below:     

  

Number of Options

  

Weighted Averaged Exercise Price $

  

Weighted Average Remaining Contractual Life (Years)

  

Aggregate Intrinsic Options Value $

 

Options outstanding January 1, 2023

  3,059,989   2.36   6.38   - 

Granted during 2023

  -   -       - 

Exercised during 2023

  -   -   -   - 

Forfeited or expired during 2023

  -   -   -   - 

Options outstanding June 30, 2023

  3,059,989   2.36   5.88   - 

Exercisable, June 30, 2023

  1,481,651   2.29   5.25   - 

 

A summary of option activity for non-employees under the plans and changes during the six months ended June 30, 2023 presented below:

  

Number of Options

  

Weighted Averaged Exercise Price $

  

Weighted Average Remaining Contractual Life (Years)

  

Aggregate Intrinsic Options Value $

 

Options outstanding January 1, 2023

  91,663   1.75   2.55   1,083 

Granted during 2023

  8,333   0.89   4.99   - 

Exercised during 2023

  -   -   -   - 

Options outstanding June 30, 2023

  99,996   1.68   2.29   7,516 

Exercisable, June 30, 2023

  86,109   1.78   1.96   6,736 

 

For the three and six months ended June 30, 2023, Milestone Scientific recognized approximately $4,900 and $12,700 expense related to non-employee options, respectively. For the three and six months ended June 30, 2022, Milestone Scientific recognized approximately $5,000 and $10,000 expense related to non-employee options, respectively.

 

The information below summarizes the restricted stock award activity for the six months ended June 30, 2023.

  

Number of Shares

  

Weighted Average Grant-Date Fair Value per Award

 

Non-vested as January 1, 2023

  435,293   1.18 

Granted

  617,978   0.89 

Vested

  (540,164)  - 

Cancelled

  -   - 

Non-vested as June 30, 2023

  513,107   0.96 

 

As of June 30, 2023, there are 49,615 restricted shares granted and deferred under the terms of  employment agreements with each Territory Manager of Milestone Scientific. Such shares will be issued to each party upon completion of 2 years of employment. For the three and six months ended June 30, 2023, the Company recognized stock compensation expense of approximately $9,400 and $19,000 respectively. For the three and six months ended June 30, 2022, the Company recognized negative stock compensation expense of approximately $54,000 and $27,000, respectively, due to termination of certain employees who had not vested in their grant in the current period.  For the six months ended June 30, 2023, the total unrecognized compensation expense was approximately $19,000, related to unvested restricted stock awards, which the Company expects to recognize over an estimated weighted-average period of .53 years. 

 

As of  June 28, 2023, the Company entered into restricted stock agreements with members of the Board of Directors of the Company. The Company granted 617,978 restricted stock awards with a fair market value of $0.89 per share. Such restricted stock vests as follows: 25% on the grant date in June 2023, and 25% quarterly, on the first day of the following months:  October 2023,  January 2023, and  April 2024. These awards vest immediately upon a change of control as defined in the agreements. For the three and six months of June 30, 2023, the Company recognized approximately $162,000 and $307,000 for restricted stock expenses recorded in general and administrative expenses on the statement of operations. For the six months of  June 30, 2023, the total unrecognized stock compensation expense was approximately $407,000 related to non-vested restricted stock awards with the members of the Board of Directors, which the Company expects to recognize over an estimated weighted average period of .75 years. 

v3.23.2
Note 7 - Income Taxes
6 Months Ended
Jun. 30, 2023
Notes to Financial Statements  
Income Tax Disclosure [Text Block]

NOTE 7 — INCOME TAXES

 

The utilization of Milestone Scientific's net operating losses may be subject to a substantial limitation due to the "change of ownership provisions" under Section 382 of the Internal Revenue Code and similar state provisions. Such limitation may result in the expiration of the net operating loss carry forwards before their utilization. Milestone Scientific has established a 100% valuation allowance for all its deferred tax assets due to uncertainty as to their future realization. 

v3.23.2
Note 8 - Segment and Geographic Data
6 Months Ended
Jun. 30, 2023
Notes to Financial Statements  
Segment Reporting Disclosure [Text Block]

NOTE 8 — SEGMENT AND GEOGRAPHIC DATA

 

We conduct our business through two reportable segments: Dental and Medical. These segments offer different products and services to different customer bases. The Company provides general corporate services to its segments; however, these services are not considered when making operating decisions and assessing segment performance. These services are reported under “Corporate Services” below and these include costs associated with executive management, investor relations, patents, trademarks, licensing agreements, new instruments developments, financing activities and public company compliance.

 

The following tables present information about our reportable and operating segments:

  

For the Three Months ended June 30, 

  

For the Six Months ended June 30, 

 

Sales

                

Net Sales:

 

2023

  

2022

  

2023

  

2022

 

Dental

 $2,912,166  $1,609,768  $5,503,564  $4,303,120 

Medical

  (2,200)  38,600   4,000   46,150 

Total net sales

 $2,909,966  $1,648,368  $5,507,564  $4,349,270 
                 

Operating Income (Loss):

 

2023

  

2022

  

2023

  

2022

 

Dental

 $598,944  $163,022  $1,240,884  $517,262 

Medical

  (863,899)  (1,615,283)  (1,685,832)  (2,851,374)

Corporate

  (2,012,595)  (1,432,618)  (3,175,278)  (2,465,249)

Total operating loss

 $(2,277,550) $(2,884,879) $(3,620,226) $(4,799,361)
                 

Depreciation and Amortization:

 

2023

  

2022

  

2023

  

2022

 

Dental

 $1,219  $893  $2,388  $1,786 

Medical

  694   1,019   1,662   2,037 

Corporate

  14,768   14,733   29,852   29,637 

Total depreciation and amortization

 $16,681  $16,645  $33,902  $33,460 

 

                 

Income (loss) before taxes and equity in earnings of affiliates:

 

2023

  

2022

  

2023

  

2022

 

Dental

 $599,126  $161,774  $1,240,295  $514,571 

Medical

  (865,735)  (1,616,733)  (1,689,503)  (2,854,273)

Corporate

  (1,962,219)  (1,426,370)  (3,098,951)  (2,460,852)

Total loss before taxes and equity in earnings of affiliate

 $(2,228,828) $(2,881,329) $(3,548,159) $(4,800,554)
                 

Total Assets

 

June 30, 2023

  

December 31, 2022

         

Dental

 $4,439,751  $3,875,978         

Medical

  452,974   620,373         

Corporate

  6,258,727   9,205,735         

Total assets

 $11,151,452  $13,702,086         

 

The following table shows a breakdown of Milestone Scientific’s product sales (net), domestically and internationally, by business segment product category: 

 

  

Three Months Ended June 30, 2023

  

Three Months Ended June 30, 2022

 

Domestic: US

 

Dental

  

Medical

  

Grand Total

  

Dental

  

Medical

  

Grand Total

 

Instruments

 $271,215  $-  $271,215  $155,028  $-  $155,028 

Handpieces

  1,130,122   (2,200)  1,127,922   801,533   18,600   820,133 

Accessories

  21,443   -   21,443   22,621   -   22,621 

Grand Total

 $1,422,780  $(2,200) $1,420,580  $979,182  $18,600  $997,782 
                         

International: Rest of World

                     

Instruments

 $474,250  $-  $474,250  $160,814  $-  $160,814 

Handpieces

  732,894   -   732,894   459,799   20,000   479,799 

Accessories

  12,242   -   12,242   9,973   -   9,973 

Grand Total

 $1,219,386  $-  $1,219,386  $630,586  $20,000  $650,586 
                         

International: China 

                      

Instruments

 $270,000  $-  $270,000  $-  $-  $- 

Handpieces

  -   -   -   -   -   - 

Accessories

  -   -   -   -   -   - 

Grand Total

 $270,000  $-  $270,000  $-  $-  $- 
                         

Total Product Sales

 $2,912,166  $(2,200) $2,909,966  $1,609,768  $38,600  $1,648,368 

 

  

Six Months Ended June 30, 2023

  

Six Months Ended June 30, 2022

 

Domestic: US

 

Dental

  

Medical

  

Grand Total

  

Dental

  

Medical

  

Grand Total

 

Instruments

 $495,683  $-  $495,683  $277,996  $-  $277,996 

Handpieces

  2,269,900   -   2,269,900   1,597,392   26,150   1,623,542 

Accessories

  44,320   -   44,320   47,481   -   47,481 

Grand Total

 $2,809,903  $-  $2,809,903  $1,922,869  $26,150  $1,949,019 
                         

International: Rest of World

                        

Instruments

 $873,205  $-  $873,205  $614,374  $-  $614,374 

Handpieces

  1,522,010   4,000   1,526,010   1,383,751   20,000   1,403,751 

Accessories

  28,446   -   28,446   22,162   -   22,162 

Grand Total

 $2,423,661  $4,000  $2,427,661  $2,020,287  $20,000  $2,040,287 

International: China

                        

Instruments

 $270,000  $-  $270,000  $-  $-  $- 

Handpieces

  -   -   -   359,964   -   359,964 

Accessories

  -   -   -   -   -   - 

Grand Total

 $270,000  $-  $270,000  $359,964  $-  $359,964 
                         

Total Product Sales

 $5,503,564  $4,000  $5,507,564  $4,303,120  $46,150  $4,349,270 

 

v3.23.2
Note 9 - Concentrations
6 Months Ended
Jun. 30, 2023
Notes to Financial Statements  
Concentration Risk Disclosure [Text Block]

NOTE 9 – CONCENTRATIONS

 

Milestone Scientific has informal arrangements with third-party U.S. manufacturers of the STA devices, and epidural instruments pursuant to which they manufacture these products under specific purchase orders which contain advance requirements but without any long-term contract or minimum purchase commitment. Advances on contracts have been classified as current at  June 30, 2023, and 2022. The termination of the manufacturing relationship with any of these manufacturers could have a material adverse effect on Milestone Scientific’s ability to produce and sell its products. Although alternate sources of supply exist, and new manufacturing relationships could be established, Milestone Scientific would need to recover its existing tools or have new tools produced. Establishment of new manufacturing relationships could involve significant expense and delay. Any curtailment or interruption of the supply, because of termination of such a relationship, would have a material adverse effect on Milestone Scientific’s financial condition, business, and results of operations.

 

On January 3, 2023, the Company launched an E-Commerce platform, selling and shipping STA Single Tooth Anesthesia System® (STA) and handpieces directly to dental offices and dental groups within the U.S. For the three months ended June 30, 2023, E-Commerce accounted for 43% of net product sales and one distributor  accounted for 11% of net product sales. For the six months ended June 30, 2023, E-Commerce accounted for 42% of  net product sales. For the three months ended June 30, 2022, an aggregate of approximately 49% of the Company’s net sales were from one distributor. For the six months ended June 30, 2022, an aggregate of approximately 11% and 38% of the Company’s net product sales were from two distributors.

 

We had three distributors that accounted for 40%, 16% and 11% of accounts receivable, respectively for the six months ended June 30, 2023. We had two customers that accounted for 33%, and 20% amount of accounts receivable, respectively as of December 31, 2022. 

 

As of  June 30, 2023, we had one vendor that accounted for 45% of accounts payable and accounts payable related party. We had one vendor that accounted for 42% of accounts payable and accounts payable related party as of December 31, 2022.

 

v3.23.2
Note 10 - Related Party Transactions
6 Months Ended
Jun. 30, 2023
Notes to Financial Statements  
Related Party Transactions Disclosure [Text Block]

NOTE 10 -- RELATED PARTY TRANSACTIONS

 

United Systems

 

Milestone Scientific has a supply  agreement with United Systems (whose controlling shareholder, Tom Cheng, is a significant stockholder of Milestone Scientific), the principal manufacturers of its handpieces, pursuant to which it manufactures products under specific purchase orders, but without minimum purchase commitments. Purchases from this manufacturer were approximately $592,000 and $1.3 million, respectively for the three and six months ended June 30, 2023. Purchases from this manufacturer were approximately $436,000 and $1.7 million, respectively for the three and six months ended June 30, 2022.

 

As of June 30, 2023 and December 31, 2022, Milestone Scientific owed this manufacturer approximately $592,000, and $819,000, respectively, which is included in accounts payable, related party and accrued expense, related party on the unaudited condensed consolidated balance sheets. 

 

Other

 

During 2022, K. Tucker Andersen, an significant stockholder of Milestone Scientific, entered into an agreement with Milestone Scientific to provide financial and business strategic services. Expenses recognized on this agreement were $25,000 and $50,000 for three and six months ended June 30, 2022. The agreement was not renewed in 2023.

 

The Director of Clinical Affairs’ royalty fee was approximately $144,000 and $267,000 for the three and six months ended June 30, 2023, respectively. The Director of Clinical Affairs’ royalty fee was approximately $81,000 and $213,000 for the three and six months ended June 30, 2022, respectively. Additionally, Milestone Scientific expensed consulting fees to the Director of Clinical Affairs of $39,000 and $78,000 for the three and six months ended June 30, 2023 and 2022, respectively.

 

As of  June 30, 2023 and December 31, 2022, Milestone Scientific owed the Director Clinical Affairs for royalties of approximately $145,000 and $120,000, respectively, which is included in accounts payable, related party and accrued expense, related party, in the condensed consolidated balance sheet.

 

Pursuant to a Succession Agreement dated April 6, 2021 between Mr. Osser and the Company: (i) the Employment Agreement dated as of July 10, 2017 between Mr. Osser and the Company, pursuant to which upon Mr. Osser stepping down as Interim Chief Executive Officer of the Company, the Company agreed to employ him as Managing Director, China Operations of the Company (the “China Operations Agreement”), and (ii) the Consulting Agreement dated as of July 10, 2017 (the “Consulting Agreement”) between the Company and U.S. Asian Consulting Group, LLC, a company of which Mr. Osser is a principal, the compensation under the China Operations Agreement was modified to reduce the overall compensation by $100,000 to $200,000, split equally between a cash amount and an amount in shares, and the compensation under the Consulting Agreement was increased by $100,000 to $200,000, equally split between a cash amount and an amount in shares, which shares were formerly payable under the China Operations Agreement.  Compensation under the China Operations Agreement and the Consulting Agreement are payable for 9.5 years from May 19, 2021. The Company recorded expense of $50,000 and $100,000 related to the Managing Director, China Operations for the three and six months ended June 30, 2023 and 2022, respectively. The Company recorded expense of $50,000 and $100,000 related to the US Asian Consulting Group, LLC for the three and six months ended June 30, 2023 and 2022, respectively.   

v3.23.2
Note 11 - Commitments
6 Months Ended
Jun. 30, 2023
Notes to Financial Statements  
Commitments and Contingencies Disclosure [Text Block]

NOTE 11 — COMMITMENTS

 

(1)  Contract Manufacturing Agreement 

 

Milestone Scientific has informal arrangements with third-party manufacturers of the STA devices, and epidural instruments pursuant to which they manufacture these products under specific purchase orders but without any long-term contract or minimum purchase commitment. The Company has a purchase commitment for the delivery of 3,000 STA instruments as of June 30, 2023. As of June 30, 2023, the purchase order commitment was approximately $2.9 million, and approximately $1.2 million was paid and reported in advances on contracts in the condensed consolidated balance sheet. As of December 31, 2022, the purchase order commitment was approximately $1.7 million, and approximately $1.2 million was paid and reported in advances on contracts in the condensed consolidated balance sheet. The advances on contracts represent funding of future epidural instruments, and epidural replacements parts. The balance of the advances as of June 30, 2023 and December 31, 2022 is approximately $75,000, respectively. The advance is classified as current based on the estimated annual usage of the underlying inventory. 

 

(2)  Leases
 
Operating Leases

 

The Company identified and assessed the following significant assumptions in recognizing its right-of-use assets and corresponding lease liabilities:

 

 

As the Company’s leases do not provide an implicit rate, the Company estimated the incremental borrowing rate in calculating the present value of the lease payments. The Company has utilized its incremental borrowing rate based on the long-term borrowing costs of comparable companies in the Medical Device industry.

 

Since the Company elected to account for each lease component and its associated non-lease components as a single combined lease component, all contract consideration was allocated to the combined lease component.

 

The expected lease terms include non-cancellable lease periods. Renewal option periods are not included in the determination of the lease terms as they were not reasonably certain to be exercised.

 

The components of lease expense were as follows:

                %
  

Three months ended June 30,

  

Six months ended June 30,

 
  

2023

  

2022

  

2023

  

2022

 

Cash paid for operating lease liabilities

 $31,882  $31,999  $63,763  $63,881 

Cash paid for finance lease liabilities

  2,685   2,685   5,370   5,370 

Right-of-use assets obtained in exchange for new operating lease liabilities (1)

      663,009       663,009 

Property and equipment obtained in exchange for new finance lease liabilities

      43,242       43,242 

Weighted Average Remaining Lease Term

                

Finance leases (years)

             

1.5 years

 

Operating leases (years)

             

3.75 years

 

Weighted-average discount rate – operating leases

              9.20%

Weighted-average discount rate – finance leases

              9.20%

 

v3.23.2
Significant Accounting Policies (Policies)
6 Months Ended
Jun. 30, 2023
Accounting Policies [Abstract]  
Consolidation, Policy [Policy Text Block]

1.  Principles of Consolidation

 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States ("GAAP") and the applicable rules and regulations of the Securities and Exchange Commission (SEC), and include the accounts of Milestone Scientific and its wholly owned and majority owned subsidiaries, including, Wand Dental (wholly owned), and Milestone Medical (majority owned).  All significant, intra-entity transactions and balances have been eliminated in the consolidation.

 

Basis of Accounting, Policy [Policy Text Block]

2. Basis of Presentation

 

The unaudited condensed consolidated financial statements of Milestone Scientific have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) for interim financial information with the instructions for Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete annual financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements contain all adjustments (consisting of normal recurring entries) necessary to fairly present such interim results. Interim results are not necessarily indicative of the results of operations which may be expected for a full year or any subsequent period. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto for the year ended December 31, 2022, included in Milestone Scientific's Annual Report on Form 10-K.

 

Use of Estimates, Policy [Policy Text Block]

3. Use of Estimates

 

The preparation of unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions in determining the reported amounts of assets and liabilities and disclosure of contingent liabilities at the date of the financial statements and reported amounts of revenues and expenses during the reporting period. The most significant estimates relate to the allowance for doubtful accounts, inventory valuation, cash flow assumptions regarding evaluations of going concern considerations, stock compensation expense, and valuation allowances on deferred tax assets. Actual results could differ from those estimates.

 

Revenue [Policy Text Block]

4.  Revenue Recognition

 

The Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services. To perform revenue recognition, the Company performs the following five steps:

 

i.

identification of the promised goods or services in the contract;

ii.

determination of whether the promised goods or services are performance obligations including whether they are distinct

in the context of the contract;        

iii.

measurement of the transaction price, including the constraint on variable consideration;

iv.

allocation of the transaction price to the performance obligations based on estimated selling prices; and

v.

recognition of revenue when (or as) the Company satisfies each performance obligation. A performance obligation is a

promise in a contract to transfer a distinct good or service to the customer and is the unit of account in ASC 606.

 

The Company derives its revenues from the sale of its products, primarily dental instruments, handpieces, and other related products. The Company sells its products directly to consumers in the United States and through a global distribution network that includes both exclusive and non-exclusive distribution agreements with related and third parties.

 

Revenue from product sales is recognized upon transfer of control of a product to a customer, generally upon date of shipment. The Company has no obligation on product sales for any installation, set-up, or maintenance, these being the responsibility of the buyer. Milestone Scientific's only obligation after sale is the normal commercial warranty against manufacturing defects if the alleged defective unit is returned within the warranty period. 

 

E-Commerce

 

As of January 3, 2023, the Company launched an E-Commerce platform, selling and shipping STA Single Tooth Anesthesia Systems® (STA) and handpieces directly to dental offices and dental groups within the United States. Our  E-commerce portal accepts online payments via credit and debit cards. The cost of delivery is charged to customer along with appropriate sales tax. The Company recognizes revenue from product sales at the time the product ships to a customer via a third party. 

 

Sales Returns

 

The Company records allowances for product returns as a reduction of revenue at the time product sales are recorded. Several factors are considered in determining whether an allowance for product returns is required, including the customers’ return rights and the Company’s historical experience with returns and the amount of product in the distribution channel not consumed by end users and subject to return. The Company relies on historical return rates to estimate returns.

 

The Company terminated its major U.S. distributor contract as of December 31, 2022. That distributor had return rights in connection with this contract termination that extended through March 31, 2023. The Company recorded allowance of approximately $179,000 for those returns within its December 31, 2022 financial statements. No returns have been  presented, and the Company reversed the allowance for sales returns.

 

Financing and Payment

 

The Company's payment terms differ by geography and customer, but payments from distributors are required within 90 days or less from the date of shipment. The E-commerce portal sells directly to end users and accepts online payments via credit and debit cards via a third-party. These payments from the third-party are settled within two business days.

 

Disaggregation of Revenue

 

The Company operates in two operating segments: dental and medical. Therefore, results of the Company's operations are reported on a consolidated basis for purposes of segment reporting, consistent with internal management reporting. See Note 8 for revenues by geographical market, based on the customer’s location, and product category for the three and six months ended June 30, 2023 and 2022.

 

Cash and Cash Equivalents, Policy [Policy Text Block]

5.  Cash and Cash Equivalents

 

Milestone Scientific considers all highly liquid investments purchased with an original maturity of three months or less to be cash equivalents. As of June 30, 2023 and December 31, 2022, Milestone Scientific has approximately $3.7 million and $8.7 million, respectively of cash and cash equivalents. As of June 30, 2023 and December 31, 2022, Milestone Scientific had approximately $3.4 million and $8.3 million, respectively, in cash, cash equivalents, and marketable securities in accounts that exceeded the Federal Deposit Insurance Corporation insurance limit of $250,000.

 

Marketable Securities, Policy [Policy Text Block]

6. Marketable Securities

 

The Company’s marketable securities are comprised of treasury bills with original maturity greater than three months from date of purchase. The Company’s marketable securities are measured at fair value and are accounted for in accordance with ASU 2016-01. Unrealized holding gains and losses on treasury bills are recorded in net realized and unrealized gain (loss) from investments on the unaudited condensed consolidated statements of operations. Dividend and interest income are recognized when earned. Realized gains and losses are included in earnings and are derived using the specific identification method for determining the cost of the marketable securities.

 

The appropriate classification of marketable securities is determined at the time of purchase and evaluated as of each reporting balance sheet date. Investments in marketable debt and equity securities classified as available-for-sale are reported at fair value. Fair value is determined using quoted market prices in active markets for identical assets or liabilities or quoted prices for similar assets or liabilities or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. Declines in the fair values of equity securities that are considered other-than-temporary, are charged to other income (expense), net. The Company considers available evidence in evaluating potential impairments of its investments, including the duration and extent to which fair value is less than cost. As of  June 30, 2023, the Company held approximately $2.0 million in  U.S. treasury securities, with  maturity dates within 3 and 6 months of the balance sheet date.

 

Accounts Receivable [Policy Text Block]

7.  Accounts Receivable

 

The e-commerce portal sells directly to end users and accepts online payments via credit and debit cards via a third-party credit card processor. These payments are settled within 2 business days of the transactions. Sales to distributors are on credit terms. The Company estimates losses from the ability or inability of its distributor to make payments on amounts billed.

 

Distributors credit sales are due in 90 days or less from the date of invoicing. As of June 30, 2023 and  December 31, 2022, accounts receivable was recorded, net of allowance for doubtful accounts of $27,000 and $10,000, respectively.

 

Inventory, Policy [Policy Text Block]

8.  Inventories

 

Inventories principally consist of finished goods and component parts stated at the lower of cost (first-in, first-out method) or net realizable value. Inventory quantities on hand are reviewed on a quarterly basis and a provision for excess, slow moving, defective, and obsolete inventory is recorded if required based on past and expected future sales, potential technological obsolescence, and product expiration requirements.

 

The valuation allowance creates a new cost basis for the inventory, and it is not subsequently marked up through a reduction in the valuation allowance based on any changes in the underlying facts and circumstances. When the valuation allowance is initially recorded, the increase to the allowance is recognized as an increase in cost of sales. The valuation allowance is only reduced if or when the underlying inventory is sold or destroyed, at which time cost of sales recognized would include the previous adjusted cost basis.

 

Earnings Per Share, Policy [Policy Text Block]

9.  Basic and Diluted Net Loss Per Common Share

 

Milestone Scientific presents “basic” earnings (loss) per common share applicable to common stockholders and, if applicable, “diluted” earnings (loss) per common share applicable to common stockholders pursuant to the provisions of ASC 260, “Earnings per Share”. Basic earnings (loss) per common share is calculated by dividing net income or loss applicable to common stockholders by the weighted average number of common shares outstanding and to be issued common shares as follows: 72,333,656 and 70,356,796 for the three months ended June 30, 2023 and 2022, respectively; and 72,048,223 and 70,585,590 for the six months ended June 30, 2023 and 2022, respectively. The calculation of diluted earnings per common share is like that of basic earnings per common share, except that the denominator is increased to include the number of additional common shares that would have been outstanding if all potentially dilutive common shares, such as those issuable upon the exercise of stock options and warrants were issued during the period.

 

Since Milestone Scientific had net losses in the six months ended June 30, 2023 and 2022, the assumed effects of the exercise of potentially dilutive outstanding stock options, unissued restricted stock awards (“RSA”) and warrants, were not included in the calculation as their effect would have been anti-dilutive. Such outstanding options, RSA's and warrants totaled  4,142,155 and 8,166,380 for the six months ended on June 30, 2023 and  2022, respectively.

 

Share-Based Payment Arrangement [Policy Text Block]

10. Stock-Based Compensation 
 

Milestone Scientific accounts for stock-based compensation under ASC Topic 718, Share-Based Payment. ASC Topic 718 requires all share-based payments to employees, non-employees, directors, and officers, including grants of employee stock options, to be recognized in the unaudited condensed consolidated statements of operations over the service period, as an operating expense, based on the grant-date fair values.

 

New Accounting Pronouncements, Policy [Policy Text Block]

11.  Recent Accounting Pronouncements

 

In June 2016, the FASB issued ASU 2016-13, Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which amends the guidance on measuring credit losses for certain financial assets measured at amortized cost, including trade receivables. The FASB has subsequently issued several updates to the standard, providing additional guidance on certain topics covered by the standard. This update requires entities to recognize an allowance for credit losses using a forward-looking expected loss impairment model, taking into consideration historical experience, current conditions, and supportable forecasts that impact collectability.

 

In November 2019, the FASB issued ASU 2019-10, Financial Instruments - Credit Losses (Topic, 326), Derivatives and hedging (Topic 815), and Leases (Topic 842): Effective dates, which deferred the effective date of ASU 2016-13 for the Company. As a result of ASU 2019-10, ASU 2016-13 is effective for all entities with fiscal years beginning after December 15, 2022, including interim periods.  As January 1, 2023, the Company adopted  ASU 2019-10, Financial Instruments - Credit Losses (Topic, 326), Derivatives and hedging (Topic 815), and Leases (Topic 842) the adoption of this ASU does not have a material impact on our financial statements.

v3.23.2
Note 4 - Inventories (Tables)
6 Months Ended
Jun. 30, 2023
Notes Tables  
Schedule of Inventory, Current [Table Text Block]
  

June 30, 2023

  

December 31, 2022

 
         

Dental finished goods

 $1,833,864  $1,315,263 

Medical finished goods

  208,081   334,124 

Component parts and other materials

  151,118   142,948 

Total inventories

 $2,193,063  $1,792,335 
v3.23.2
Note 6 - Stockholders' Equity (Tables)
6 Months Ended
Jun. 30, 2023
Notes Tables  
Schedule of Stockholders' Equity Note, Warrants or Rights [Table Text Block]
  

Warrant shares outstanding

  

Weighted Average exercise price

  

Weighted Average remaining life

  

Intrinsic value

 
                 

Outstanding at January 1, 2023

  4,268,221   2.18   0.50   - 

Issued

  -   -   -   - 

Exercised

  -   -   -   - 

Expired or cancelled

  (3,953,649)  -   -   - 

Outstanding and exercisable at June 30, 2023

  314,572   0.50   0.60   116,549 
Deferred Compensation Arrangement with Individual, Share-based Payments [Table Text Block]
  

June 30, 2023

  

June 30, 2022

 
         

Shares-to-be-issued, outstanding January 1, 2023 and 2022, respectively

  2,440,673   2,066,343 

Granted in current period

  322,092   108,148 

Issued in current period

  -   (147,338)

Shares-to be issued outstanding June 30, 2023 and 2022, respectively

  2,762,765   2,027,153 
Share-Based Payment Arrangement, Option, Activity [Table Text Block]
  

Number of Options

  

Weighted Averaged Exercise Price $

  

Weighted Average Remaining Contractual Life (Years)

  

Aggregate Intrinsic Options Value $

 

Options outstanding January 1, 2023

  3,059,989   2.36   6.38   - 

Granted during 2023

  -   -       - 

Exercised during 2023

  -   -   -   - 

Forfeited or expired during 2023

  -   -   -   - 

Options outstanding June 30, 2023

  3,059,989   2.36   5.88   - 

Exercisable, June 30, 2023

  1,481,651   2.29   5.25   - 
  

Number of Options

  

Weighted Averaged Exercise Price $

  

Weighted Average Remaining Contractual Life (Years)

  

Aggregate Intrinsic Options Value $

 

Options outstanding January 1, 2023

  91,663   1.75   2.55   1,083 

Granted during 2023

  8,333   0.89   4.99   - 

Exercised during 2023

  -   -   -   - 

Options outstanding June 30, 2023

  99,996   1.68   2.29   7,516 

Exercisable, June 30, 2023

  86,109   1.78   1.96   6,736 
Restricted Stock [Member]  
Notes Tables  
Disclosure of Share-Based Compensation Arrangements by Share-Based Payment Award [Table Text Block]
  

Number of Shares

  

Weighted Average Grant-Date Fair Value per Award

 

Non-vested as January 1, 2023

  435,293   1.18 

Granted

  617,978   0.89 

Vested

  (540,164)  - 

Cancelled

  -   - 

Non-vested as June 30, 2023

  513,107   0.96 
v3.23.2
Note 8 - Segment and Geographic Data (Tables)
6 Months Ended
Jun. 30, 2023
Notes Tables  
Schedule of Segment Reporting Information, by Segment [Table Text Block]
  

For the Three Months ended June 30, 

  

For the Six Months ended June 30, 

 

Sales

                

Net Sales:

 

2023

  

2022

  

2023

  

2022

 

Dental

 $2,912,166  $1,609,768  $5,503,564  $4,303,120 

Medical

  (2,200)  38,600   4,000   46,150 

Total net sales

 $2,909,966  $1,648,368  $5,507,564  $4,349,270 
                 

Operating Income (Loss):

 

2023

  

2022

  

2023

  

2022

 

Dental

 $598,944  $163,022  $1,240,884  $517,262 

Medical

  (863,899)  (1,615,283)  (1,685,832)  (2,851,374)

Corporate

  (2,012,595)  (1,432,618)  (3,175,278)  (2,465,249)

Total operating loss

 $(2,277,550) $(2,884,879) $(3,620,226) $(4,799,361)
                 

Depreciation and Amortization:

 

2023

  

2022

  

2023

  

2022

 

Dental

 $1,219  $893  $2,388  $1,786 

Medical

  694   1,019   1,662   2,037 

Corporate

  14,768   14,733   29,852   29,637 

Total depreciation and amortization

 $16,681  $16,645  $33,902  $33,460 
                 

Income (loss) before taxes and equity in earnings of affiliates:

 

2023

  

2022

  

2023

  

2022

 

Dental

 $599,126  $161,774  $1,240,295  $514,571 

Medical

  (865,735)  (1,616,733)  (1,689,503)  (2,854,273)

Corporate

  (1,962,219)  (1,426,370)  (3,098,951)  (2,460,852)

Total loss before taxes and equity in earnings of affiliate

 $(2,228,828) $(2,881,329) $(3,548,159) $(4,800,554)
                 

Total Assets

 

June 30, 2023

  

December 31, 2022

         

Dental

 $4,439,751  $3,875,978         

Medical

  452,974   620,373         

Corporate

  6,258,727   9,205,735         

Total assets

 $11,151,452  $13,702,086         
Sales by Product and by Geographical Region [Table Text Block]
  

Three Months Ended June 30, 2023

  

Three Months Ended June 30, 2022

 

Domestic: US

 

Dental

  

Medical

  

Grand Total

  

Dental

  

Medical

  

Grand Total

 

Instruments

 $271,215  $-  $271,215  $155,028  $-  $155,028 

Handpieces

  1,130,122   (2,200)  1,127,922   801,533   18,600   820,133 

Accessories

  21,443   -   21,443   22,621   -   22,621 

Grand Total

 $1,422,780  $(2,200) $1,420,580  $979,182  $18,600  $997,782 
                         

International: Rest of World

                     

Instruments

 $474,250  $-  $474,250  $160,814  $-  $160,814 

Handpieces

  732,894   -   732,894   459,799   20,000   479,799 

Accessories

  12,242   -   12,242   9,973   -   9,973 

Grand Total

 $1,219,386  $-  $1,219,386  $630,586  $20,000  $650,586 
                         

International: China 

                      

Instruments

 $270,000  $-  $270,000  $-  $-  $- 

Handpieces

  -   -   -   -   -   - 

Accessories

  -   -   -   -   -   - 

Grand Total

 $270,000  $-  $270,000  $-  $-  $- 
                         

Total Product Sales

 $2,912,166  $(2,200) $2,909,966  $1,609,768  $38,600  $1,648,368 
  

Six Months Ended June 30, 2023

  

Six Months Ended June 30, 2022

 

Domestic: US

 

Dental

  

Medical

  

Grand Total

  

Dental

  

Medical

  

Grand Total

 

Instruments

 $495,683  $-  $495,683  $277,996  $-  $277,996 

Handpieces

  2,269,900   -   2,269,900   1,597,392   26,150   1,623,542 

Accessories

  44,320   -   44,320   47,481   -   47,481 

Grand Total

 $2,809,903  $-  $2,809,903  $1,922,869  $26,150  $1,949,019 
                         

International: Rest of World

                        

Instruments

 $873,205  $-  $873,205  $614,374  $-  $614,374 

Handpieces

  1,522,010   4,000   1,526,010   1,383,751   20,000   1,403,751 

Accessories

  28,446   -   28,446   22,162   -   22,162 

Grand Total

 $2,423,661  $4,000  $2,427,661  $2,020,287  $20,000  $2,040,287 

International: China

                        

Instruments

 $270,000  $-  $270,000  $-  $-  $- 

Handpieces

  -   -   -   359,964   -   359,964 

Accessories

  -   -   -   -   -   - 

Grand Total

 $270,000  $-  $270,000  $359,964  $-  $359,964 
                         

Total Product Sales

 $5,503,564  $4,000  $5,507,564  $4,303,120  $46,150  $4,349,270 
v3.23.2
Note 11 - Commitments (Tables)
6 Months Ended
Jun. 30, 2023
Notes Tables  
Lease, Cost and Other Information [Table Text Block]
                %
  

Three months ended June 30,

  

Six months ended June 30,

 
  

2023

  

2022

  

2023

  

2022

 

Cash paid for operating lease liabilities

 $31,882  $31,999  $63,763  $63,881 

Cash paid for finance lease liabilities

  2,685   2,685   5,370   5,370 

Right-of-use assets obtained in exchange for new operating lease liabilities (1)

      663,009       663,009 

Property and equipment obtained in exchange for new finance lease liabilities

      43,242       43,242 

Weighted Average Remaining Lease Term

                

Finance leases (years)

             

1.5 years

 

Operating leases (years)

             

3.75 years

 

Weighted-average discount rate – operating leases

              9.20%

Weighted-average discount rate – finance leases

              9.20%
v3.23.2
Note 2- Liquidity and Uncertainties (Details Textual) - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Dec. 31, 2022
Retained Earnings (Accumulated Deficit) $ (119,934,388)   $ (119,934,388)   $ (116,410,405)
Operating Income (Loss) $ (2,277,550) $ (2,884,879) $ (3,620,226) $ (4,799,361)  
v3.23.2
Note 3 - Summary of Significant Accounting Policies (Details Textual)
3 Months Ended 6 Months Ended 12 Months Ended
Jun. 30, 2023
USD ($)
shares
Jun. 30, 2022
shares
Jun. 30, 2023
USD ($)
shares
Jun. 30, 2022
shares
Dec. 31, 2022
USD ($)
Allowance for Sales Returns     $ 0   $ 179,000
Number of Operating Segments     2    
Cash, Uninsured Amount $ 3,400,000   $ 3,400,000   8,300,000
Marketable Securities, Current 1,981,180   1,981,180   0
Accounts Receivable, Allowance for Credit Loss $ 27,000   $ 27,000   10,000
Weighted Average Number of Shares Outstanding, Basic (in shares) | shares 72,333,656 70,356,796 72,048,223 70,585,590  
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount (in shares) | shares     4,142,155 8,166,380  
US Treasury Securities [Member]          
Marketable Securities, Current $ 2,000,000.0   $ 2,000,000.0    
Money Market Funds [Member]          
Cash Equivalents, at Carrying Value $ 3,700,000   $ 3,700,000   $ 8,700,000
v3.23.2
Note 4 - Inventories (Details Textual) - USD ($)
$ in Millions
Jun. 30, 2023
Dec. 31, 2022
Slow Moving Medical Finished Goods [Member]    
Inventory Valuation Reserves $ 1.1 $ 1.0
v3.23.2
Note 4 - Inventories - Summary of Inventories (Details) - USD ($)
Jun. 30, 2023
Dec. 31, 2022
Mar. 31, 2022
Component parts and other materials $ 151,118   $ 142,948
Total inventories 2,193,063 $ 1,792,335 1,792,335
Dental Segment [Member]      
Finished goods, net 1,833,864   1,315,263
Medical Segment [Member]      
Finished goods, net $ 208,081   $ 334,124
v3.23.2
Note 5 - Advances on Contracts (Details Textual) - USD ($)
Jun. 30, 2023
Dec. 31, 2022
Advances on Inventory Purchases $ 1,282,806 $ 1,325,301
v3.23.2
Note 6 - Stockholders' Equity (Details Textual) - USD ($)
3 Months Ended 6 Months Ended
Jun. 28, 2023
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Dec. 31, 2022
Dec. 31, 2021
Deferred Compensation Arrangement with Individual, Shares Authorized for Issuance (in shares)   2,762,765 2,027,153 2,762,765 2,027,153 2,440,673 2,066,343
Share-Based Payment Arrangement, Option [Member] | Share-Based Payment Arrangement, Nonemployee [Member]              
Share-Based Payment Arrangement, Expense   $ 4,900 $ 5,000 $ 12,700 $ 10,000    
Share-Based Payment Arrangement, Option [Member] | General and Administrative Expense [Member]              
Share-Based Payment Arrangement, Expense   229,000 $ 223,000 $ 457,000 $ 501,000    
Restricted Stock [Member]              
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value (in dollars per share)       $ 0.89      
Restricted Stock [Member] | General and Administrative Expense [Member]              
Share-Based Payment Arrangement, Expense   $ 162,000   $ 307,000      
The 2020 Equity Incentive Plan [Member] | Share-Based Payment Arrangement, Option [Member]              
Share-Based Compensation Arrangement by Share-Based Payment Award, Number of Additional Shares Authorized (in shares)       11,500,000      
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Period (Year)       3 years      
The 2020 Equity Incentive Plan [Member] | Vice Chairman of the Board of Directors [Member]              
Share-Based Compensation Arrangement by Share-Based Payment Award, Expiration Period (Year)       5 years      
Chief Executive Officer, and Other Employees [Member]              
Deferred Compensation Arrangement with Individual, Shares Authorized for Issuance (in shares)   2,380,068 1,852,789 2,380,068 1,852,789    
Non-Employees [Member]              
Common Stock, Capital Shares Reserved for Future Issuance (in shares)   382,697 174,364 382,697 174,364    
Territory Manager [Member] | Restricted Stock [Member]              
Deferred Compensation Arrangement with Individual, Shares Authorized for Issuance (in shares)   49,615   49,615      
Share-Based Payment Arrangement, Expense   $ 9,400 $ 54,000 $ 19,000 $ 27,000    
Deferred Compensation Arrangement with Individual, Requisite Service Period (Year)       2 years      
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount   19,000   $ 19,000      
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year)       6 months 10 days      
Board of Directors [Member] | Restricted Stock [Member]              
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Amount   $ 407,000   $ 407,000      
Share-Based Payment Arrangement, Nonvested Award, Cost Not yet Recognized, Period for Recognition (Year)       9 months      
Share-Based Compensation Arrangement by Share-Based Payment Award, Non-Option Equity Instruments, Granted (in shares) 617,978            
Share-Based Compensation Arrangement by Share-Based Payment Award, Equity Instruments Other than Options, Grants in Period, Weighted Average Grant Date Fair Value (in dollars per share) $ 0.89            
Director [Member] | Restricted Stock [Member] | Share-Based Payment Arrangement, Tranche One [Member]              
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Rights, Percentage       25.00%      
Director [Member] | Restricted Stock [Member] | Share-Based Payment Arrangement, Tranche Two [Member]              
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Rights, Percentage       25.00%      
v3.23.2
Note 6 - Stockholders' Equity - Warrants (Details) - USD ($)
6 Months Ended 12 Months Ended
Jun. 30, 2023
Dec. 31, 2022
Outstanding, number of shares (in shares) 4,268,221  
Outstanding, weighted average exercise price (in dollars per share) $ 2.18  
Outstanding, weighted average remaining life (Year) 7 months 6 days 6 months
Outstanding, Intrinsic value $ 116,549 $ 0
Issued, number of shares (in shares) 0  
Issued, weighted average exercise price (in dollars per share) $ 0  
Exercised, number of shares (in shares) 0  
Exercised, weighted average exercise price (in dollars per share) $ 0  
Expired or cancelled, number of shares (in shares) (3,953,649)  
Expired or cancelled, weighted average exercise price (in dollars per share) $ 0  
Outstanding and exercisable at June 30, 2023 (in shares) 314,572 4,268,221
Outstanding and exercisable at June 30, 2023 (in dollars per share) $ 0.50 $ 2.18
v3.23.2
Note 6 - Stockholders' Equity - Summary of Shares to be Issued (Details) - shares
6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Shares-to-be-issued, outstanding (in shares) 2,440,673 2,066,343
Granted in current period (in shares) 322,092 108,148
Issued in current period (in shares) 0 (147,338)
Shares-to be issued outstanding June 30, 2023 and 2022, respectively (in shares) 2,762,765 2,027,153
v3.23.2
Note 6 - Stockholders' Equity - Summary of Option Activity for Employees (Details) - USD ($)
6 Months Ended 12 Months Ended
Jun. 30, 2023
Dec. 31, 2022
Aggregate intrinsic value, outstanding   $ 1,083
Share-Based Payment Arrangement, Option [Member] | Share-Based Payment Arrangement, Employee [Member]    
Options outstanding, balance (in shares) 3,059,989  
Weighted average exercise price, outstanding (in dollars per share) $ 2.36  
Weighted average remaining contractual life, outstanding (Year) 5 years 10 months 17 days 6 years 4 months 17 days
Aggregate intrinsic value, outstanding $ 0  
Granted, options (in shares) 0  
Weighted average exercise price, granted (in dollars per share) $ 0  
Exercised, options (in shares) 0  
Weighted average exercise price, exercised (in dollars per share) $ 0  
Forfeited and expired, options (in shares) 0  
Weighted average exercise price, forfeited or expired (in dollars per share) $ 0  
Options outstanding, balance (in shares) 3,059,989 3,059,989
Weighted average exercise price, outstanding (in dollars per share) $ 2.36 $ 2.36
Exercisable, options (in shares) 1,481,651  
Weighted average exercise price, exercisable (in dollars per share) $ 2.29  
Weighted average remaining contractual life, exercisable (Year) 5 years 3 months  
Exercised, options (in shares) (0)  
Share-Based Payment Arrangement, Option [Member] | Share-Based Payment Arrangement, Nonemployee [Member]    
Options outstanding, balance (in shares) 91,663  
Weighted average exercise price, outstanding (in dollars per share) $ 1.75  
Weighted average remaining contractual life, outstanding (Year) 2 years 3 months 14 days 2 years 6 months 18 days
Aggregate intrinsic value, outstanding $ 7,516  
Granted, options (in shares) 8,333  
Weighted average exercise price, granted (in dollars per share) $ 0.89  
Exercised, options (in shares) 0  
Weighted average exercise price, exercised (in dollars per share) $ 0  
Options outstanding, balance (in shares) 99,996 91,663
Weighted average exercise price, outstanding (in dollars per share) $ 1.68 $ 1.75
Exercisable, options (in shares) 86,109  
Weighted average exercise price, exercisable (in dollars per share) $ 1.78  
Weighted average remaining contractual life, exercisable (Year) 1 year 11 months 15 days  
Weighted average remaining contractual life, granted (Year) 4 years 11 months 26 days  
Exercised, options (in shares) 0  
Aggregate intrinsic value, exercisable $ 6,736  
v3.23.2
Note 6 - Stockholders' Equity - Schedule of Restricted Stock (Details) - Restricted Stock [Member]
6 Months Ended
Jun. 30, 2023
$ / shares
shares
Non-vested as January 1, 2023 (in shares) 435,293
Non-vested as January 1, 2023 (in dollars per share) | $ / shares $ 1.18
Granted, Shares (in shares) 617,978
Granted, Weighted Average Grant-Date Fair Value per Award (in dollars per share) | $ / shares $ 0.89
Vested, Shares (in shares) (540,164)
Vested, Weighted Average Grant-Date Fair Value per Award (in dollars per share) | $ / shares $ 0
Cancelled, , Weighted Average Grant-Date Fair Value per Award (in shares) 0
Non-vested as June 30, 2023 (in shares) 513,107
Non-vested as June 30, 2023 (in dollars per share) | $ / shares $ 0.96
v3.23.2
Note 7 - Income Taxes (Details Textual)
6 Months Ended
Jun. 30, 2023
Percentage of Valuation Allowance 100.00%
v3.23.2
Note 8 - Segment and Geographic Data (Details Textual)
6 Months Ended
Jun. 30, 2023
Number of Reportable Segments 2
v3.23.2
Note 8 - Segment and Geographic Data - Summary by Reporting and Operating Segments (Details) - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Dec. 31, 2022
Product sales, net $ 2,909,966 $ 1,648,368 $ 5,507,564 $ 4,349,270  
Operating Income (Loss) (2,277,550) (2,884,879) (3,620,226) (4,799,361)  
Depreciation and Amortization 16,681 16,645 33,902 33,460  
Income (loss) before taxes and equity in earnings of affiliates: (2,228,828) (2,881,329) (3,548,159) (4,800,554)  
Total assets 11,151,452 13,702,086 11,151,452 13,702,086 $ 13,702,086
Dental Segment [Member]          
Product sales, net 2,912,166 1,609,768 5,503,564 4,303,120  
Medical Segment [Member]          
Product sales, net (2,200) 38,600 4,000 46,150  
Operating Segments [Member] | Dental Segment [Member]          
Product sales, net 2,912,166 1,609,768 5,503,564 4,303,120  
Operating Income (Loss) 598,944 163,022 1,240,884 517,262  
Depreciation and Amortization 1,219 893 2,388 1,786  
Income (loss) before taxes and equity in earnings of affiliates: 599,126 161,774 1,240,295 514,571  
Total assets 4,439,751 3,875,978 4,439,751 3,875,978  
Operating Segments [Member] | Medical Segment [Member]          
Product sales, net (2,200) 38,600 4,000 46,150  
Operating Income (Loss) (863,899) (1,615,283) (1,685,832) (2,851,374)  
Depreciation and Amortization 694 1,019 1,662 2,037  
Income (loss) before taxes and equity in earnings of affiliates: (865,735) (1,616,733) (1,689,503) (2,854,273)  
Total assets 452,974 620,373 452,974 620,373  
Corporate, Non-Segment [Member]          
Operating Income (Loss) (2,012,595) (1,432,618) (3,175,278) (2,465,249)  
Depreciation and Amortization 14,768 14,733 29,852 29,637  
Income (loss) before taxes and equity in earnings of affiliates: (1,962,219) (1,426,370) (3,098,951) (2,460,852)  
Total assets $ 6,258,727 $ 9,205,735 $ 6,258,727 $ 9,205,735  
v3.23.2
Note 8 - Segment and Geographic Data - Summary of Operations by Geographic Area (Details) - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Product sales, net $ 2,909,966 $ 1,648,368 $ 5,507,564 $ 4,349,270
CHINA        
Product sales, net 270,000 0 270,000 359,964
Domestic [Member]        
Product sales, net 1,420,580 997,782 2,809,903 1,949,019
Rest of World [Member]        
Product sales, net 1,219,386 650,586 2,427,661 2,040,287
Instruments [Member] | CHINA        
Product sales, net 270,000 0 270,000 0
Instruments [Member] | Domestic [Member]        
Product sales, net 271,215 155,028 495,683 277,996
Instruments [Member] | Rest of World [Member]        
Product sales, net 474,250 160,814 873,205 614,374
Handpieces [Member] | CHINA        
Product sales, net 0 0 0 359,964
Handpieces [Member] | Domestic [Member]        
Product sales, net 1,127,922 820,133 2,269,900 1,623,542
Handpieces [Member] | Rest of World [Member]        
Product sales, net 732,894 479,799 1,526,010 1,403,751
Accessories [Member] | CHINA        
Product sales, net 0 0 0 0
Accessories [Member] | Domestic [Member]        
Product sales, net 21,443 22,621 44,320 47,481
Accessories [Member] | Rest of World [Member]        
Product sales, net 12,242 9,973 28,446 22,162
Dental Segment [Member]        
Product sales, net 2,912,166 1,609,768 5,503,564 4,303,120
Dental Segment [Member] | CHINA        
Product sales, net 270,000 0 270,000 359,964
Dental Segment [Member] | Domestic [Member]        
Product sales, net 1,422,780 979,182 2,809,903 1,922,869
Dental Segment [Member] | Rest of World [Member]        
Product sales, net 1,219,386 630,586 2,423,661 2,020,287
Dental Segment [Member] | Instruments [Member] | CHINA        
Product sales, net 270,000 0 270,000 0
Dental Segment [Member] | Instruments [Member] | Domestic [Member]        
Product sales, net 271,215 155,028 495,683 277,996
Dental Segment [Member] | Instruments [Member] | Rest of World [Member]        
Product sales, net 474,250 160,814 873,205 614,374
Dental Segment [Member] | Handpieces [Member] | CHINA        
Product sales, net 0 0 0 359,964
Dental Segment [Member] | Handpieces [Member] | Domestic [Member]        
Product sales, net 1,130,122 801,533 2,269,900 1,597,392
Dental Segment [Member] | Handpieces [Member] | Rest of World [Member]        
Product sales, net 732,894 459,799 1,522,010 1,383,751
Dental Segment [Member] | Accessories [Member] | CHINA        
Product sales, net 0 0 0 0
Dental Segment [Member] | Accessories [Member] | Domestic [Member]        
Product sales, net 21,443 22,621 44,320 47,481
Dental Segment [Member] | Accessories [Member] | Rest of World [Member]        
Product sales, net 12,242 9,973 28,446 22,162
Medical Segment [Member]        
Product sales, net (2,200) 38,600 4,000 46,150
Medical Segment [Member] | CHINA        
Product sales, net 0 0 0 0
Medical Segment [Member] | Domestic [Member]        
Product sales, net (2,200) 18,600 0 26,150
Medical Segment [Member] | Rest of World [Member]        
Product sales, net 0 20,000 4,000 20,000
Medical Segment [Member] | Instruments [Member] | CHINA        
Product sales, net 0 0 0 0
Medical Segment [Member] | Instruments [Member] | Domestic [Member]        
Product sales, net 0 0 0 0
Medical Segment [Member] | Instruments [Member] | Rest of World [Member]        
Product sales, net 0 0 0 0
Medical Segment [Member] | Handpieces [Member] | CHINA        
Product sales, net 0 0 0 0
Medical Segment [Member] | Handpieces [Member] | Domestic [Member]        
Product sales, net (2,200) 18,600 0 26,150
Medical Segment [Member] | Handpieces [Member] | Rest of World [Member]        
Product sales, net 0 20,000 4,000 20,000
Medical Segment [Member] | Accessories [Member] | CHINA        
Product sales, net 0 0 0 0
Medical Segment [Member] | Accessories [Member] | Domestic [Member]        
Product sales, net 0 0 0 0
Medical Segment [Member] | Accessories [Member] | Rest of World [Member]        
Product sales, net $ 0 $ 0 $ 0 $ 0
v3.23.2
Note 9 - Concentrations (Details Textual)
3 Months Ended 6 Months Ended 12 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Dec. 31, 2022
Revenue Benchmark [Member] | Customer Concentration Risk [Member]          
Number of Distributors 1 1 1 1  
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | E-Commerce [Member]          
Concentration Risk, Percentage 43.00%   42.00%    
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Distributor One [Member]          
Concentration Risk, Percentage 11.00% 49.00%   11.00%  
Revenue Benchmark [Member] | Customer Concentration Risk [Member] | Distributor Two [Member]          
Concentration Risk, Percentage       38.00%  
Accounts Receivable [Member] | Customer Concentration Risk [Member]          
Number of Distributors 3 2 3 2  
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Distributor One [Member]          
Concentration Risk, Percentage     40.00% 33.00%  
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Distributor Two [Member]          
Concentration Risk, Percentage     16.00% 20.00%  
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Distributor Three [Member]          
Concentration Risk, Percentage     11.00%    
Accounts Payable [Member] | Supplier Concentration Risk [Member] | Related Party [Member]          
Number of Vendors 1   1   1
Accounts Payable [Member] | Supplier Concentration Risk [Member] | Vendor One [Member] | Related Party [Member]          
Concentration Risk, Percentage     45.00%   42.00%
v3.23.2
Note 10 - Related Party Transactions (Details Textual) - USD ($)
3 Months Ended 6 Months Ended
Jul. 10, 2017
Jun. 30, 2023
Mar. 31, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Dec. 31, 2022
Previous President and Chief Executive Officer [Member]              
Increase (Decrease) in Deferred Compensation $ (100,000)            
Employment Agreement, Base Compensation 200,000            
Consultant [Member]              
Increase (Decrease) in Deferred Compensation (100,000)            
Employment Agreement, Base Compensation $ 200,000            
Director of Clinical Affairs [Member]              
Accounts Payable and Accrued Liabilities, Current   $ 145,000     $ 145,000   $ 120,000
Royalty Expense   144,000   $ 81,000 267,000 $ 213,000  
Professional Fees   39,000   39,000 78,000 78,000  
Manufacturing Agreement for Handpieces [Member]              
Related Party Transaction, Purchases from Related Party   592,000   436,000 1,300,000 1,700,000  
Manufacturing Agreement for Handpieces [Member] | Related Party [Member]              
Accounts Payable and Accrued Liabilities, Current   592,000     592,000   $ 819,000
Consulting Services [Member]              
Costs and Expenses, Related Party   25,000     50,000    
Managing Director, China Operations [Member]              
Deferred Compensation Arrangement with Individual, Compensation Expense     $ 50,000 50,000 100,000 100,000  
Consultant [Member]              
Deferred Compensation Arrangement with Individual, Compensation Expense   $ 50,000   $ 50,000 $ 100,000 $ 100,000  
v3.23.2
Note 11 - Commitments (Details Textual)
6 Months Ended
Jun. 30, 2023
USD ($)
Dec. 31, 2022
USD ($)
Advances on Inventory Purchases $ 1,282,806 $ 1,325,301
Purchase Commitment for Devices [Member]    
Purchase Commitment Number Of Units 3,000  
Purchase Commitment, Remaining Minimum Amount Committed $ 2,900,000 1,700,000
Advances on Inventory Purchases 1,200,000 1,200,000
Purchase Commitment For Devices Beginning In 2021 [Member]    
Advances on Inventory Purchases $ 75,000 $ 75,000
v3.23.2
Note 11 - Commitments - Lease Expense (Details) - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Cash paid for operating lease liabilities $ 31,882 $ 31,999 $ 63,763 $ 63,881
Cash paid for finance lease liabilities $ 2,685 2,685 $ 5,370 5,370
Right-of-use assets obtained in exchange for new operating lease liabilities (1)   663,009   663,009
Property and equipment obtained in exchange for new finance lease liabilities   $ 43,242   $ 43,242
Finance leases (years) (Year)   1 year 6 months   1 year 6 months
Operating leases (years) (Year)   3 years 9 months   3 years 9 months
Weighted-average discount rate – operating leases   9.20%   9.20%

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