MILESTONE SCIENTIFIC INC.

Form 10-Q 

TABLE OF CONTENTS

	PART I—FINANCIAL INFORMATION
Item 1.	Condensed Consolidated Financial Statements
	Balance Sheets as of June 30, 2024 (Unaudited) and December 31, 2023	4
	Statements of Operations for the three and six months ended June 30, 2024 and 2023 (Unaudited)	5
	Statements of Changes in Stockholders’ Equity for the three and six months ended June 30, 2024 and 2023 (Unaudited)	6
	Statements of Cash Flows for the six months ended June 30, 2024 and 2023 (Unaudited)	8
	Notes to Condensed Consolidated Financial Statements (Unaudited)	9
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	22
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	29
Item 4.	Controls and Procedures	29
	PART II—OTHER INFORMATION
Item 1.	Legal Proceedings	29
Item 1A.	Risk Factors	29
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	29
Item 3.	Defaults Upon Senior Securities	30
Item 4.	Mine Safety Disclosures	30
Item 5.	Other Information	30
Item 6.	Exhibits	31
Signatures		32

 

 

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 changes in the distribution of its products and continued evolution 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 relative 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 or 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 because of various factors. Except as required by the federal securities laws, Milestone Scientific undertakes no obligation to revise or update any forward-looking statements, whether as a result of new information, future events or otherwise, to reflect events or circumstances occurring after the date of this Quarterly Report on Form 10-Q.

 

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 ®.

 

 

Part I- Financial Information

Item 1. Financial Statements

MILESTONE SCIENTIFIC AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

 

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

 

 

 

MILESTONE SCIENTIFIC AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

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

 

 

MILESTONE SCIENTIFIC AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY

FOR THREE AND SIX MONTHS ENDED JUNE 30,  2024 AND 2023

(UNAUDITED)

 

 

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

 

 

 

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

 

MILESTONE SCIENTIFIC AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

FOR SIX MONTHS ENDED

(UNAUDITED)

 

 

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

 

MILESTONE SCIENTIFIC, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

NOTE 1 — ORGANIZATION AND BUSINESS

All references in this report to “Milestone Scientific,” the “Company” or “Milestone” refer to Milestone Scientific Inc., and its consolidated subsidiaries, Wand Dental, Inc., and Milestone Innovation Inc., 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 Company’s proprietary DPS Dynamic Pressure Sensing Technology is the Company’s 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.

 

The Company’s 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 currently sold in the United States, Canada and in over 41 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.

 

The Company is in the process of meeting with medical facilities and device distributors within the United States, Middle East and Europe. Certain of our medical instruments have obtained European CE mark approval and can be marketed and sold in most European countries.

 

In 2020, the Company received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) related to its new CompuPulse System, which combines the benefits of our CompuWave technology with a manual syringe. The new CompuPulse System allows one to identify a pulsatile pressure waveform in a variety of applications, thereby improving the reliability and safety of a drug delivery procedure. Importantly, not all procedures require the sophistication of our CompuFlo system, which precisely controls the administration and flow rate of medication as it is being administered. This new technology provides an efficient and low-cost alternative for procedures where a manual syringe  may suffice, while still providing the ability to verify needle and subsequent catheter placement.

 

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 consolidated financial statements are issued. The Company has incurred total losses since inception of $124.6 million. The operating losses were $1.8 million and $3.2 million, for three and six months ended June 30, 2024. On June 30, 2024, Milestone Scientific had cash and cash equivalents of approximately $5.8 million and working capital of approximately $7.7 million. For the six months ended June 30, 2024, and 2023, we had cash flows used in operating activities of approximately $0.4 million and $3.0 million respectively. 

 

In April 2024, we received approximately $2.0 million, net of expenses, from the sale of New Jersey net operating losses (“NOL”), that were eligible for sale under the State of New Jersey’s Economic Development Authority’s New Jersey Technology Business Tax Certificate Transfer Program (”NJEDA Program”). The Company recorded this amount within Gain on sale of net operating losses within the consolidated statement of operations (unaudited).

 

Pursuant to the NJEDA program, the Company must retain a physical presence in the state of New Jersey for a period of 5 years after the sale of the of the NOLs. If the Company does not retain a physical presence during the 5 years after the sale of the NOLs, the Company can be liable to pay the state of New Jersey up to $2.2 million of the surrendered NOLs.

 

Management has prepared financial forecasts covering a period of 12 months from the date of issuance of these financial statements. 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 12 months from the filing date.

 

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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. 

 

NOTE 3 — SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

1.  Principles of Consolidation

 

The accompanying consolidated unaudited 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) include the accounts of Milestone Scientific and its wholly owned and majority owned subsidiaries, including, Wand Dental (wholly owned), and Milestone Innovations Inc. (wholly owned).  All significant, intra-entity transactions and balances have been eliminated in the consolidation. Ownership interests in consolidated entities that are held by entities other than us are reported as noncontrolling interests in our consolidated balance sheets. Losses attributed to noncontrolling interests are reported separately in our consolidated statements of operations.

 

During December 2023, the Board of Directors of the Company approved a resolution to repurchase the remaining minority stake of Milestone Medical, Inc. for $214,000. Concurrently, the Company transferred the net assets of Milestone Medical, Inc. to a newly created, wholly owned subsidiary, Milestone Innovations, Inc, a Delaware corporation.

 

2. Basis of Presentation

 

The unaudited 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 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 consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto for the year ended December 31, 2023, included in Milestone Scientific's Annual Report on Form 10-K.

 

3. Use of Estimates

 

The preparation of unaudited 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 inventory valuation and cash flow assumptions regarding evaluations of going concern considerations. The Company bases its estimates on historical experience, known trends and other market-specific or relevant factors that it believes to be reasonable under the circumstances. On an ongoing basis, management evaluates its estimates as there are changes in circumstances, facts and experience. Changes in estimates are recorded in the period in which they become known. 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:

 

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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 the 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 carrier. 

 

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.

 

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 typically settled within two business days.

 

Disaggregation of Revenue

 

The Company operates in two operating segments: dental and medical. Therefore, the results of the Company's operations are reported on a consolidated basis for the 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 periods ended June 30, 2024, and 2023, respectively.

 

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, 2024, and December 31, 2023, Milestone Scientific has approximately $5.8 million and $3.0 million, respectively of cash and cash equivalents. As of June 30, 2024, Milestone Scientific had approximately $5.2 million in cash, cash equivalents, in accounts that exceeded the Federal Deposit Insurance Corporation insurance limit of $250,000.

 

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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 ASC 825, Financial Instruments. Unrealized holding gains and losses on treasury bills are recorded in interest income on the unaudited 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. As of  June 30, 2024, the Company did not hold any marketable securities. As of  December 31, 2023 the Company held approximately $3.0 million in U.S. treasury securities, with maturity dates within 3 and 6 months.

 

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 two 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 90 days or less from the date of invoicing. As of June 30, 2024 and  December 31, 2023, accounts receivable was recorded, net of allowance for credit losses of $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: 79,966,833 and 72,333,656 for the three months ended June 30, 2024 and 2023, respectively, and 80,412,397 and 72,048,223 for the six months ended June 30, 2024 and 2023, 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, 2024 and the three and six months ended June 30 2023, 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 3,128,652 and 4,142,155 for the six months ended June 30, 2024 and 2023, respectively.

 

10. Fair Value of Financial Instruments

 

Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants in the principal market at the measurement date (exit price). The Company required us to classify fair value measurements in one of the following categories.

●

Level 1 inputs which are defined as quoted prices (unadjusted) in active markets for identical assets or liabilities that the Company can access at the measurement date.

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Level 2 inputs which are defined as inputs other than quoted prices included within Level 1 that are observable for the assets or liabilities, either directly or indirectly.

●

Level 3 inputs are defined as unobservable inputs for the assets or liabilities.

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Financial assets and liabilities are classified based on the lowest level of input that is significant to the fair value measurement. Our assessment of the significance of an input to the fair value measurement requires judgment and  may affect the valuation of the fair value of assets and liabilities and their placement within the fair value hierarchy levels.

 

As of  June 30, 2024 the Company did not have assets measured at fair value on a recurring basis. As of December 31, 2023 the Company had the following assets that were measured at fair value on a recurring basis: 

 

		Level 1				Level 2				Level 3				Total
Marketable Securities December 31, 2023			2,976,573				-				-				2,976,573

 

Marketable Securities included US Treasury securities totaling $2,976,573 that are considered to be highly liquid and easily transferable at  December 31, 2023. US Treasury securities are valued using inputs observable in active markets for identical securities and are therefore classified at Level 1 within the Company fair value hierarchy.

 

11. Stock-Based Compensation 
 

Milestone Scientific accounts for stock-based compensation under ASC Topic 718, Share-Based Payment (“ASC Topic 718”). 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 consolidated statements of operations over the service period, as an operating expense, based on the grant-date fair values.

 

12.  Recent Accounting Pronouncements

 

Recently Issued Accounting Pronouncement

 

In November 2023, FASB issued ASU 2023-07, Segment Reporting (Topic 280), Improvements to Reportable Segment Disclosures, which provides improvements to reportable segment disclosure requirements, primarily through enhanced disclosures around segment expenses. ASU 2023-07 requires us to disclose significant segment expenses that are regularly provided to the chief operating decision maker (“CODM”) and included within each reported measure of segment profit or loss. ASU 2023-07 also requires that the Company disclose an amount for other segment items by reportable segment, a description of their composition and provide all annual disclosures about a reportable segment’s profit or loss and assets pursuant to Topic 280 during interim periods. The Company must also disclose the CODM’s title and position, as well as certain information around the measures used by the CODM and an explanation of how the CODM uses the reported measures in assessing segment performance and deciding how to allocate resources. For public entities with a single reportable segment, the entity must provide all the disclosures required pursuant to ASU 2023-07 and all existing segment disclosures under Topic 280. The amendments of ASU 2023-07 are effective for the Company for annual periods beginning January 1, 2024, and effective for interim periods beginning January 1, 2025. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. The Company expects to adopt this standard effective January 1, 2024, at December 31, 2024 on the Company’s annual Form 10-K filing. The Company expects to update all required disclosures pursuant to this ASU 2023-07 at that time. The Company is evaluating the impact of ASU 2023-07 on our financial statements.

 

In December 2023, FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, to enhance the transparency and decision usefulness of income tax disclosures. The amendments in ASU 2023-09 provide improvements primarily related to the rate reconciliation and income taxes paid information included in income tax disclosures. The Company would be required to disclose additional information regarding reconciling items equal to or greater than five percent of the amount computed by multiplying pretax income (loss) by the applicable statutory tax rate. Similarly, the Company would be required to disclose income taxes paid (net of refunds received) equal to or greater than five percent of total income taxes paid (net of refunds received). Additionally, the Company would be required to disclose income (loss) from continuing operations before income tax expense disaggregated by foreign and domestic jurisdictions, as well as income tax expense disaggregated by federal, state, and foreign jurisdictions. The amendments in ASU 2023-09 are effective January 1, 2025, including interim periods. Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance. The Company will evaluate the impact of ASU 2023-09 on our financial statements.

 

 

NOTE 4 — INVENTORIES

 

Inventories consist of the following: 

		June 30, 2024				December 31, 2023
Dental finished goods		$	3,282,009			$	2,404,970
Medical finished goods			-				14,730
Component parts and other materials			47,092				218,486
Total inventories		$	3,329,101			$	2,638,186

 

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 $1.2 million as of June 30, 2024 and  December 31, 2023, 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 on contract as of June 30, 2024 and December 31, 2023 is approximately $1.3 and $1.4 million, respectively. The advance is classified as current based on the estimated annual usage of the underlying inventory.  

 

NOTE 6— STOCKHOLDERS’ EQUITY

 

Public offering

 

On  December 10, 2023, the Company completed a public offering for sale of 4,765,000 common stock, at $0.63 per share which generated net proceeds of approximately $2.6 million. In addition, the Company granted the Underwriter a 45-day option to purchase up to an additional 714,750 shares of Common Stock at the same price to cover over-allotments.

 

In connection with the Company's capital raise on  December 10, 2023, on  January 12, 2024 the underwriter exercised its over-allotment option as to 372,110 shares of common stock for net proceeds after discounts and commission of $192,156.

 

Warrants

 

The following table summarizes information about shares issuable under warrants outstanding as of June 30, 2024:

 

		Warrant shares outstanding				Weighted Average exercise price				Weighted Average remaining life				Intrinsic value
Outstanding at January 1, 2024			314,572				0.50				0.10				59,737
Issued			-				-				-				-
Exercised			(103,500	)			0.50				-				-
Expired or cancelled			(211,072	)			0.50				-				-
Outstanding and exercisable at June 30, 2024			-				-				-				-

 

During the six months ended June 30, 2024, the Company issued 103,500 shares of common stock for warrants issued in 2019. The warrants were exercised at $0.50 for proceeds of $51,751.

 

Shares to Be Issued

 

As of June 30, 2024 and 2023, respectively, there were 2,657,058 and 2,380,068 shares issuable, the issuance of which has been deferred under the terms of employment agreements with the Chief Executive Officer and other employees of Milestone Scientific. Such shares are issuable to each party upon termination of their respective employment.

 

As of June 30, 2024 and 2023, respectively, there were 527,625 and 382,697 shares issuable to non-employees, for services rendered. The number of shares was fixed at the date of grant and were fully vested upon grant date.

 

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The following table summarizes activity for shares to be issued for the six months periods ending June 30, 2024 and 2023.

 

		June 30, 2024				June 30, 2023
Shares-to-be-issued, outstanding January 1, 2024 and 2023, respectively			3,098,917				2,440,673
Granted in current period			438,868				322,092
Issued in current period			(353,102	)			-
Shares-to be issued outstanding June 30, 2024 and 2023, respectively			3,184,683				2,762,765

 

Stock Options Plans

 

The Milestone Scientific Inc., Amended and Restated 2020 Equity Incentive Plan (the “2020 Plan”), provides for awards of restricted common, stock restricted stock units, options to purchase and other awards.  On June 28, 2023 the 2020 Plan was amended and restated to increase the maximum shares that can be issued thereunder to 11,500,000 shares of common stock. The plan 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. Generally, 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 expenses over the requisite service period and in the case of performance-based options over the period of the expected performance. For the three and six months ended June 30, 2024, Milestone Scientific recognized approximately $170,000 and $358,000 of total employee compensation cost, respectively, recorded in general and administrative expenses on the statement of operations. For the 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.

 

As of June 30, 2024, there was $1.2 million of total unrecognized compensation cost related to non-vested options. Milestone Scientific expects to recognize these costs over a weighted average period of 1.8 years.

 

A summary of option activity for employees under the plans and changes six months ended June 30, 2024 is presented below:

 

		Number of Options				Weighted Averaged Exercise Price $				Weighted Average Remaining Contractual Life (Years)				Aggregate Intrinsic Options Value $
Options outstanding January 1, 2024			3,036,989				2.29				5.41				-
Granted during 2024			-				-								-
Exercised during 2024			-				-				-				-
Forfeited or expired during 2024			-				-				-				-
Options outstanding June 30, 2024			3,036,989				2.32				4.91				-
Exercisable, June 30, 2024			2,188,433				2.29				4.31				-

A summary of option activity for non-employees under the plans and changes during the six months ended June 30, 2024 presented below:

		Number of Options				Weighted Averaged Exercise Price $				Weighted Average Remaining Contractual Life (Years)				Aggregate Intrinsic Options Value $
Options outstanding January 1, 2024			91,663				1.76				2.25				2,833
Granted during 2024			8,333				0.64				4.85				-
Exercised during 2024			-				-				-				-
Forfeited or expired during 2024			(8,333	)			0.35				-				-
Options outstanding June 30, 2024			91,663				1.79				1.95				333
Exercisable, June 30, 2024			80,551				1.94				1.65				111

 

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For the three and six months ended June 30, 2024, Milestone Scientific recognized approximately $1,100 and $2,200, respectively of expense related to non-employee options. For the three and six months ended June 30, 2023, Milestone Scientific recognized approximately $4,900 and $12,700, respectively of expense related to non-employee options.

 

The information below summarizes the restricted stock award activity for the six months ended June 30, 2024.

		Number of Shares				Weighted Average Grant-Date Fair Value per Award
Non-vested as January 1, 2024			327,937				0.91
Granted			-				-
Vested			(327,937	)			0.91
Cancelled			-				-
Non-vested as June 30, 2024			-				-

 

As of June 30, 2024, all restricted shares granted and deferred under the terms of employment agreements with each Territory Manager of Milestone Scientific are fully vested. For the three and six  months ended June 30, 2024, the Company recognized stock compensation expense of approximately $0 and $2,100 respectively. 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 six months ended June 30, 2024, there was no unrecognized compensation expense. 

 

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 2024, and  April 2024. These awards vest immediately upon a change of control as defined in the agreements. For the three and six months ended June 30, 2024, the Company recognized approximately $20,500 and $158,000, respectively, for restricted stock expenses recorded in general and administrative expenses on the statement of operations. For the three and six months ended June 30, 2023, the Company recognized approximately $162,000 and $307,000, respectively, for restricted stock expenses recorded in general and administrative expenses on the statement of operations. For the six months ended June 30, 2024, there was no unrecognized compensation expense

 

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. 

 

In April 2024, we received approximately $2.0 million, net of expenses, from the sale of New Jersey net operating losses (“NOL”), that were eligible for sale under the State of New Jersey’s Economic Development Authority’s New Jersey Technology Business Tax Certificate Transfer Program (”NJEDA Program”). The Company recorded this amount within Gain on sale of net operating losses within the consolidated statement of operations (unaudited).

 

Pursuant to the NJEDA program, the Company must retain a physical presence in the state of New Jersey for a period of 5 years after the sale of the of the NOLs. If the Company does not retain a physical presence during the 5 years after the sale of the NOLs, the Company can be liable to pay the state of New Jersey up to $2.2 million of the surrendered NOLs.

 

NOTE 8 — SEGMENT AND GEOGRAPHIC DATA

 

The Company conducts its 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.

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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:		2024				2023				2024				2023
Dental		$	1,834,764			$	2,912,166			$	4,076,189			$	5,503,564
Medical			19,000				(2,200	)			26,420				4,000
Total net sales		$	1,853,764			$	2,909,966			$	4,102,609			$	5,507,564
Operating Income (Loss):		2024				2023				2024				2023
Dental		$	193,243			$	598,944			$	818,750			$	1,240,884
Medical			(528,315	)			(863,899	)			(1,019,740	)			(1,685,832	)
Corporate			(1,445,351	)			(2,012,595	)			(3,044,501	)			(3,175,278	)
Total operating loss		$	(1,780,423	)		$	(2,277,550	)		$	(3,245,491	)		$	(3,620,226	)
Depreciation and Amortization:		2024				2023				2024				2023
Dental		$	-			$	1,219			$	-			$	2,388
Medical			-				694				-				1,662
Corporate			8,477				14,768				20,161				29,852
Total depreciation and amortization		$	8,477			$	16,681			$	20,161			$	33,902
Income (loss) before taxes and equity in earnings of affiliates:		2024				2023				2024				2023
Dental		$	193,266			$	599,126			$	817,776			$	1,240,295
Medical			(528,091	)			(865,735	)			(1,020,022	)			(1,689,503	)
Corporate			558,463				(1,962,219	)			(1,014,645	)			(3,098,951	)
Total income (loss) before taxes and equity in earnings of affiliate		$	223,638			$	(2,228,828	)		$	(1,216,891	)		$	(3,548,159	)
Total Assets		June 30, 2024				December 31, 2023
Dental		$	5,132,387			$	4,866,786
Medical			451,680				345,194
Corporate			6,421,173				6,159,532
Total assets		$	12,005,240			$	11,371,512

 

 

 

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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, 2024												Three Months Ended June 30, 2023
Domestic: US		Dental				Medical				Grand Total				Dental				Medical				Grand Total
Instruments		$	194,676			$	1,000			$	195,676			$	271,215			$	-			$	271,215
Handpieces			1,136,124				18,000				1,154,124				1,130,122				(2,200	)			1,127,922
Accessories			14,977				-				14,977				21,443				-				21,443
Grand Total		$	1,345,777			$	19,000			$	1,364,777			$	1,422,780			$	(2,200	)		$	1,420,580
International: Rest of World
Instruments		$	125,176			$	-			$	125,176			$	474,250			$	-			$	474,250
Handpieces			357,645				-				357,645				732,894				-				732,894
Accessories			6,166				-				6,166				12,242				-				12,242
Grand Total		$	488,987			$	-			$	488,987			$	1,219,386			$	-			$	1,219,386
International: China
Instruments		$	-			$	-			$	-			$	270,000			$	-			$	270,000
Handpieces			-				-				-				-				-				-
Accessories			-				-				-				-				-				-
Grand Total		$	-			$	-			$	-			$	270,000			$	-			$	270,000
Total Product Sales		$	1,834,764			$	19,000			$	1,853,764			$	2,912,166			$	(2,200	)		$	2,909,966

 

		Six Months Ended June 30, 2024												Six Months Ended June 30, 2023
Domestic: US		Dental				Medical				Grand Total				Dental				Medical				Grand Total
Instruments		$	408,551			$	1,000			$	409,551			$	495,683			$	-			$	495,683
Handpieces			2,216,557				25,420				2,241,977				2,269,900				-				2,269,900
Accessories			31,667				-				31,667				44,320				-				44,320
Grand Total		$	2,656,775			$	26,420			$	2,683,195			$	2,809,903			$	-			$	2,809,903
International: Rest of World
Instruments		$	407,262			$	-			$	407,262			$	873,205			$	-			$	873,205
Handpieces			1,004,594				-				1,004,594				1,522,010				4,000				1,526,010
Accessories			7,558				-				7,558				28,446				-				28,446
Grand Total		$	1,419,414			$	-			$	1,419,414			$	2,423,661			$	4,000			$	2,427,661
International: China
Instruments		$	-			$	-			$	-			$	270,000			$	-			$	270,000
Handpieces			-				-				-				-				-				-
Accessories			-				-				-				-				-				-
Grand Total		$	-			$	-			$	-			$	270,000			$	-			$	270,000
Total Product Sales		$	4,076,189			$	26,420			$	4,102,609			$	5,503,564			$	4,000			$	5,507,564

 

 

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 contains advance payments for long lead items for production. Advances on contracts have been classified as current at  June 30, 2024 and December 31, 2023. 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, 2024, E-Commerce accounted for 66% of net product sales. For the six months ended June 30, 2024, E-Commerce accounted for 59% of net product sales. For the three months ended June 30, 2023, E-commerce accounted for 43% of net product sales and one international 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. 

 

The Company had four distributors that accounted for 34%, 31%, 13% and 11%  of accounts receivable, respectively, as of June 30, 2024. The Company had three distributors that accounted for 39%, 38%, and 15% of accounts receivable, respectively as of December 31, 2023. 

 

As of June 30, 2024, the Company had three suppliers that accounted for 36% 12% and 11%, respectively, of accounts payable and accounts payable, related party. The Company had three vendors that accounted for 37%, 17% and 12% respectively of accounts payable and accounts payable, related party as of December 31, 2023.

 

 

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 manufacturer of our handpieces, pursuant to which the manufacture is under specific purchase orders, but without minimum purchase commitments. Purchases from this manufacturer were approximately $423,000 and $1.2 million for the three and six  months ended June 30, 2024. Purchases from this manufacturer were approximately $592,000 and  $1.3 million for the three and six months ended June 30, 2023.

 

As of June 30, 2024 and December 31, 2023, Milestone Scientific owed this manufacturer approximately $803,000, and $402,000, respectively, which is included in accounts payable, related party and accrued expense, related party on the unaudited consolidated balance sheets. 

 

Director of Clinical Affairs

 

The Director of Clinical Affairs’ royalty fee was approximately $95,000 and $211,000 for the three and six months ended June 30, 2024, respectively. 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. 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, 2024 and 2023, respectively. As of June 30, 2024 and December 31, 2023, Milestone Scientific owed the Director of Clinical Affairs for royalties of approximately $100,000 and $114,000, respectively, which is included in accounts payable, related party and accrued expense, related party, in the unaudited consolidated balance sheets. 

 

Leonard Osser, Director

 

On March 2, 2021, the Company entered into a Royalty Sharing Agreement with Leonard Osser, pursuant to which Mr. Osser sold, transferred and assigned to the Company all of his rights in and to a certain patent application as to which he is a co-inventor with Mark Hochman, a consultant to the Company, and the Company agreed to pay to Mr. Osser, beginning May 9, 2027, half of the royalty (2.5%) on net sales that would otherwise be payable to Mark and Claudia Hochman under their existing Technology Sale Agreement, dated January 1, 2005 and amended from time to time, with the Company. In connection with the Royalty Sharing Agreement, the Hochman's agreed with the Company, pursuant to an addendum to such Technology Sale Agreement dated February 25, 2021, to reduce from 5% to 2.5% the payments due to them under their Technology Sale Agreement beginning on May 9, 2027, and thereafter with respect to dental products embodying the invention.

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As part of the Succession Plan of the Company, Mr. Osser agreed, pursuant to an agreement dated April 6, 2021 (the “Succession Agreement”), to restructure certain of his existing agreements with the Company, which provide for additional and broader executive support, and at such time as he elects to step down as Interim Chief Executive Officer of the Company, to become the Vice Chairman of the Board of the Company.

 

With respect to Mr. Osser’s July 2017 Employment Agreement and July 2017 Consulting Agreement (each as previously disclosed), the compensation under the Employment 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 Employment Agreement. If the Company terminates Mr. Osser’s employment “Without Cause,” other than due to his death or disability, or if Mr. Osser terminates his employment for “Good Reason” (both as defined in the agreement), Mr. Osser is entitled to be paid in one lump sum payment as soon as practicable following such termination: an amount equal to the aggregate present value (as determined in accordance with Section 280G(d)(4) of the Code) of all compensation pursuant to this agreement from the effective date of termination hereunder through the remainder of the Employment Term. In connection with his acceptance of the Vice Chairman position and in consideration of his services as a member of the Board and agreement to provide certain additional general consulting services, Mr. Osser was granted options to purchase 2,000,000 shares of common stock, exercisable at the fair market value of the common stock on the date of grant, vesting over the five-year period after he steps down as Interim Chief Executive Officer of the Company or ten years from the date of grant, whichever shall end first. The Company believes that the effect of such existing agreements and the Succession Agreement, all of which relate to the period after such time Mr. Osser steps down as Interim Chief Executive Officer of the Company, collectively expand Mr. Osser’s consulting to and support of the Company beyond its Chinese operations to also include its medical and other products, while enhancing the retention aspects of the Company’s relationship with Mr. Osser. On May 19, 2021, Mr. Osser resigned as Interim Chief Executive Officer of the Company and assumed the role of Vice Chairman of the Board. 

 

Compensation under the Employment Agreement and the Consulting Agreement is payable for 9.5 years from May 19, 2021. The Company recorded expenses of $50,000 and $100,000 related to the Employment Agreement for the three and six months ended June 30, 2024 and 2023, respectively. The Company recorded expenses of $50,000 and $100,000 related to the Consulting Agreement for the three and six months ended June 30, 2024 and 2023, respectively

 

Dr. D. Demesmin, Director

 

As of February 2024, the University Pain Medicine Center (STEMMEE), of which Dr. D. Demesmin, a Company board member is the CEO agreed to purchases products from the Company under the same terms and conditions applying to other medical pain clinics in the United States. STEMMEE purchased medical products in the amount of $6,000 and $9,000 for three and six months ended June 2024 from the Company.

 

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 2,000 STA instruments as of June 30, 2024. As of June 30, 2024, the purchase order commitment was approximately $2.1 million, and approximately $1.1 million was paid and reported in advance on contracts in the consolidated balance sheet. As of June 30, 2024 the Company recorded approximately $103,000 for the development of the next generation instrument in advances on contracts in the consolidated balance sheet. As of  December 31, 2023, the purchase order commitment was approximately $2.3 million, and approximately $1.3 million was paid and reported in advance on contracts in the consolidated balance sheet. 

 

The advances on contracts represent funding of future epidural instruments, and epidural replacements parts. As of June 30, 2024 and December 31, 2023 the company also has advances on an open purchase order for long lead items for a future purchase order for the manufacturing of Epidural instrument of approximately $168,000 and $41,000 respectively.

 

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(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								Six months ended
		June 30, 2024				June 30, 2023				June 30, 2024				June 30, 2023
Cash paid for operating lease liabilities		$	33,390			$	31,882			$	65,272			$	63,763
Cash paid for finance lease liabilities			2,685				2,685				5,370				5,370
Weighted Average Remaining Lease Term
Finance leases (years)											0.55 years				1.5 years
Operating leases (years)											2.75 years				3.75 years
Weighted-average discount rate – operating leases											9.20	%			9.20	%
Weighted-average discount rate – finance leases											9.20	%			9.20	%

 

NOTE 12 — SUBSEQUENT EVENTS

 

As of  July 16, 2024, the Company entered into restricted stock agreements with members of the Board of Directors of the Company. The Company granted 730,337 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 July 2024, and 25% quarterly, on the first day of the following months:  October 2024,  January 2025, and  April 2025. These awards vest immediately upon a change of control as defined in the agreements. 

 

 

ITEM 2. Management’s 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, 2023, which was filed with the Securities and Exchange Commission, or SEC on March 29, 2024. 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 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. We believe our technologies are proven and well established. Our common stock has been listed on the NYSE American since June 1, 2015, and trades under the symbol “MLSS”.

 

We focus 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.

 

We have developed a proprietary, revolutionary, computer-controlled anesthetic delivery device, our 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. Our proprietary DPS Dynamic Pressure Sensing technology is our technology platform that advances the development of next-generation devices. It regulates the flow rate and monitors the 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.

 

Our device, using The Wand®, a single use disposable handpiece, 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. The dental devices currently are sold in the United States, Canada and in over 41 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 spine region. In addition, Milestone Scientific has obtained CE mark approval and can be marketed and sold in most European countries.

 

Our recent receipt of the chronology-Specific CPT Code for the Company's technology by the American Medical Association marks an important milestone, that could increase the potential number of anesthesia pain management clinics adopting the CompuFlo instrument. 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 U.S

 

Milestone Scientific and its subsidiaries currently hold over 245 U.S. and foreign patents, and many patents pending and patent applications. The Company’s patents and patent applications relate to drug delivery methodologies, Peripheral Nerve Block, drug flow rate measurement, pressure/force computer-controlled drug delivery with exit pressure, dynamic pressure sensing, automated rate control, automated charging, drug profiles, audible and visual pressure/force feedback, tissue identification, identification of a target region drug delivery injection unit, drug drive unit for anesthetic, handpiece, and injection device.

 

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.

 

Our dental devices have been used to administer over 92 million injections worldwide. Each of our devices has a related single use disposable handpiece, leading to a continuing revenue stream following the 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.

 

Building on the success of our proprietary, core technology platform for dental injections, and desiring to pursue other growth opportunities, we have 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.

 

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 92 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, we received FDA regulatory clearance to sell the CompuFlo Epidural Computer Controlled Anesthesia System in the United States 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, and cervical thoracic junction 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 epidural analgesia during labor and delivery procedures. 

 

On June 18, 2024, the Company announced that it has received regulatory approval from Brazil's National Health Surveillance Agency (ANVISA) to market and sell its CompuFlo® Epidural System in Brazil. The approval includes the lumbar, thoracic, and cervical-thoracic junction of the spine.

 

On July 10, 2024, the Company announced that First Coast Service Options Inc. (FCSO), a Jurisdictional Medicare Administrative Contractor (“JMAC”), has granted favorable Medicare Part B physician price assignment across Florida for use of the Company’s CompuFlo® Epidural System under the American Medical Association’s (AMA) technology-specific Category III CPT® code CPT0777T (real-time pressure-sensing epidural guidance system when used in conjunction with a primary ESI procedure).

 

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, 2024												Three Months Ended June 30, 2023
Domestic: US		Dental				Medical				Grand Total				Dental				Medical				Grand Total
Instruments		$	194,676			$	1,000			$	195,676			$	271,215			$	-			$	271,215
Handpieces			1,136,124				18,000				1,154,124				1,130,122				(2,200	)			1,127,922
Accessories			14,977				-				14,977				21,443				-				21,443
Grand Total		$	1,345,777			$	19,000			$	1,364,777			$	1,422,780			$	(2,200	)		$	1,420,580
International: Rest of World
Instruments		$	125,176			$	-			$	125,176			$	474,250			$	-			$	474,250
Handpieces			357,645				-				357,645				732,894				-				732,894
Accessories			6,166				-				6,166				12,242				-				12,242
Grand Total		$	488,987			$	-			$	488,987			$	1,219,386			$	-			$	1,219,386
International: China
Instruments		$	-			$	-			$	-			$	270,000			$	-			$	270,000
Handpieces			-				-				-				-				-				-
Accessories			-				-				-				-				-				-
Grand Total		$	-			$	-			$	-			$	270,000			$	-			$	270,000
Total Product Sales		$	1,834,764			$	19,000			$	1,853,764			$	2,912,166			$	(2,200	)		$	2,909,966

 

		Six Months Ended June 30, 2024												Six Months Ended June 30, 2023
Domestic: US		Dental				Medical				Grand Total				Dental				Medical				Grand Total
Instruments		$	408,551			$	1,000			$	409,551			$	495,683			$	-			$	495,683
Handpieces			2,216,557				25,420				2,241,977				2,269,900				-				2,269,900
Accessories			31,667				-				31,667				44,320				-				44,320
Grand Total		$	2,656,775			$	26,420			$	2,683,195			$	2,809,903			$	-			$	2,809,903
International: Rest of World
Instruments		$	407,262			$	-			$	407,262			$	873,205			$	-			$	873,205
Handpieces			1,004,594				-				1,004,594				1,522,010				4,000				1,526,010
Accessories			7,558				-				7,558				28,446				-				28,446
Grand Total		$	1,419,414			$	-			$	1,419,414			$	2,423,661			$	4,000			$	2,427,661
International: China
Instruments		$	-			$	-			$	-			$	270,000			$	-			$	270,000
Handpieces			-				-				-				-				-				-
Accessories			-				-				-				-				-				-
Grand Total		$	-			$	-			$	-			$	270,000			$	-			$	270,000
Total Product Sales		$	4,076,189			$	26,420			$	4,102,609			$	5,503,564			$	4,000			$	5,507,564

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, 2024 and 2023, respectively. The trends suggested by this table may not be indicative of future operating results:  

 

		For the three months ended June 30, 2024				For the three months ended June 30, 2023				For the six months ended June 30, 2024				For the six months ended June 30, 2023
Operating results:
Product sales, net		$	1,853,764			$	2,909,966			$	4,102,609			$	5,507,564
Cost of products sold			442,560				1,019,907				1,015,302				1,728,882
Gross profit			1,411,204				1,890,059				3,087,307				3,778,682
Operating expenses:
Selling, general and administrative expenses			2,868,182				3,937,281				5,903,458				7,011,012
Research and development expenses			314,968				213,647				409,179				353,994
Depreciation and amortization expense			8,477				16,681				20,161				33,902
Total operating expenses			3,191,627				4,167,609				6,332,798				7,398,908
Loss from operations			(1,780,423	)			(2,277,550	)			(3,245,491	)			(3,620,226	)
Gain on sale of net operating losses			1,983,095				-				1,983,095				-
Other income, and interest net			20,966				48,722				45,505				72,067
Net income (loss)			223,638				(2,228,828	)			(1,216,891	)			(3,548,159	)
Net income (loss) attributable to noncontrolling interests			-				(12,511	)			-				(24,176	)
Net income (loss) attributable to Milestone Scientific Inc.		$	223,638			$	(2,216,317	)		$	(1,216,891	)		$	(3,523,983	)
Cash flow:			June 30, 2024				June 30, 2023
Net cash provided by (used in) operating activities		$	(434,473	)		$	(3,027,126	)
Net cash provided by (used in) investing activities		$	2,969,977			$	(1,982,376	)
Net cash provided by (used in) financing activities		$	238,889			$	(4,324	)

 

Three months ended June 30, 2024 compared three months ended June 30, 2023

 

Net sales for 2024 and 2023 were as follows:

 

		2024				2023				Change
Dental		$	1,834,764			$	2,912,166			$	(1,077,402	)
Medical			19,000				(2,200	)		$	21,200
Total sales, net		$	1,853,764			$	2,909,966			$	(1,056,202	)

 

Consolidated revenue for the three months ended June 30, 2024 and 2023 was approximately $1.9 million and $2.9 million, respectively, a decrease of approximately $1.1 million. On January 3, 2023, the Company launched an E-Commerce platform, to replace its previous U.S. distribution arrangement with Henry Schein by 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 and dental service revenue for the three months ended June 30, 2024 was approximately $1.3 million compared $1.2 million for the three months ended June 30, 2023. The Company terminated its remaining U.S. distributor in September, 2023. The Company recorded no revenue from other U.S. distributors for the three months ended June 30, 2024 compared to approximately $214,000 for the three months ended June 30, 2023. For the three months ended June 30, 2024, international revenue was approximately $490,000 a decrease of $710,000, compared to June 30, 2023. International sales decreased due to issues with freight forwarder carrier during the quarter. The Company recorded no revenue from China for the three months ended June 30, 2024 compared to approximately $270,000 for the three months ended June 30, 2023.

 

 

 

Gross Profit for 2024 and 2023 were as follows:

 

		2024				2023				Change
Dental		$	1,392,109			$	1,970,863			$	(578,754	)
Medical			19,095				(80,804	)		$	99,899
Total gross profit		$	1,411,204			$	1,890,059			$	(478,855	)

 

Consolidated gross profit for the three months ended June 30, 2024 was approximately $1.4 million, a decrease of approximately $479,000, compared to approximately $1.9 million for the same period in 2023. The decrease was due to higher margins in sales associated with the launch of E-Commerce platform offset by an decrease in International sales. The decrease is also associated with the Company recording an allowance for medical inventory due slow commercialization and the sales commencing during the six months ended June 30, 2024.

 

Selling, general and administrative expenses for 2024 and 2023 were as follows:

 

		2024				2023				Change
Dental		$	884,547			$	1,166,645			$	(282,098	)
Medical			546,760				772,810				(226,050	)
Corporate			1,436,875				1,997,826				(560,951	)
Total selling, general and administrative expenses		$	2,868,182			$	3,937,281			$	(1,069,099	)

 

Consolidated selling, general and administrative expenses for the three months ended June 30, 2024 and 2023 were approximately $2.9 million and $3.9 million, respectively. The decrease of approximately $1.1 million is due to factors in several areas. Employee salaries and benefits expenses decreased approximately $597,000 for the three months ended June 30, 2024 compared to the same period in 2023. The decrease is due to a lower head count, and stock compensation expense. The Company decreased marketing, and royalties expenses professional fees, quality control, regulatory, other selling, general and administrative expenses by approximately $490,000. The Company recorded an decrease in travel, and warehousing of approximately $8,000 for the three months ended June 30, 2024 compared to the same period in 2023.

 

Research and Development for 2024 and 2023 were as follows:

 

		2024				2023				Change
Dental		$	314,319			$	204,057			$	110,262
Medical			649				9,590				(8,941	)
Corporate			-				-				-
Total research and development		$	314,968			$	213,647			$	101,321

 

Consolidated research and development expenses for the three months ended June 30, 2024 and 2023 were approximately $315,000 and $214,000, respectively. The increase of approximately $101,000 is related to the Company's entering into the final stage of the development of  the next generation STA Single Tooth Anesthesia System.

 

Profit (Loss) from Operations for 2024 and 2023 were as follows:

 

		2024				2023				Change
Dental		$	193,243			$	598,944			$	(405,701	)
Medical			(528,315	)			(863,899	)			335,585
Corporate			(1,445,351	)			(2,012,595	)			567,244
Total loss from operations		$	(1,780,423	)		$	(2,277,550	)		$	497,127

 

The loss from operations was approximately $1.8 million and $2.3 million for the three months ended June 30, 2024 and 2023, respectively, a decrease of approximately $497,000. 

 

 

Six months ended June 30, 2024 compared three months ended June 30, 2023

 

Net sales for 2024 and 2023 were as follows:

 

		2024				2023				Change
Dental		$	4,076,189			$	5,503,564			$	(1,427,375	)
Medical			26,420				4,000				22,420
Total sales, net		$	4,102,609			$	5,507,564			$	(1,404,955	)

 

Consolidated revenue for the six months ended June 30, 2024 and 2023 was approximately $4.1 million and $5.5 million, respectively, a decrease of approximately $1.4 million. On  January 3, 2023, the Company launched an E-Commerce platform, to replace its previous U.S. distribution arrangement with Henry Schein by 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 and dental service revenue for the six months ended June 30, 2024 was approximately $2.7 million compared $2.2 million at June 30, 2023. The Company terminated its remaining U.S. distributor in September 2023. The Company recorded no revenue from other U.S. distributors for the six months ended June 30, 2024 compared to approximately $432,000 for the six months ended June 30, 2023. For the six months ended June 30, 2024, international revenue was approximately $1.4 million, a decrease of $1.0 million, compared to June 30, 2023. International sales decreased due to issues with freight forwarders carrier during the quarter. The Company recorded no revenue from China for the six months ended June 30, 2024 compared to approximately $270,000 for the six months ended June 30, 2023.

 

Gross Profit for 2024 and 2023 were as follows:

 

		2024				2023				Change
Dental		$	3,065,235			$	3,859,279			$	(794,044	)
Medical			22,072				(80,597	)			102,669
Total gross profit		$	3,087,307			$	3,778,682			$	(691,375	)

 

Consolidated gross profit for the three months ended June 30, 2024 was approximately $3.1 million, a decrease of approximately $691,000, compared to approximately $3.8 million for the same period in 2023. The decrease was due to higher margins in sales associated with the launch of E-Commerce platform offset by an decrease in International sales. The decrease is also associated with the Company recording an allowance for medical inventory due slow commercialization and the sales commencing during the six months ended June 30, 2024.

 

Selling, general and administrative expenses for 2024 and 2023 were as follows:

 

		2024				2023				Change
Dental		$	1,838,216			$	2,283,209			$	(444,993	)
Medical			1,040,902				1,582,378				(541,476	)
Corporate			3,024,340				3,145,425				(121,085	)
Total selling, general and administrative expenses		$	5,903,458			$	7,011,012			$	(1,107,554	)

 

Consolidated selling, general and administrative expenses for the six months ended June 30, 2024 and 2023 were approximately $6.0 million and $7.0 million, respectively. The decrease of approximately $1.1 million is due to factors in several areas. Employee salaries and benefits expenses decreased approximately $871,000 for the six months ended June 30, 2024 compared to the same period in 2023. The Company decreased marketing, other selling, general and administrative expenses, travel, warehousing quality control, regulatory, and royalties expenses by approximately by $327,000 The Company recorded an increase in professional fees of approximately $80,000 for the six months ended June 30, 2024 compared to the same period in 2023.

 

Research and Development for 2024 and 2023 were as follows:

 

		2024				2023				Change
Dental		$	408,270			$	332,800			$	75,470
Medical			909				21,194				(20,285	)
Corporate			-				-				-
Total research and development		$	409,179			$	353,994			$	55,185

 

Consolidated research and development expenses for the six months ended June 30, 2024 and 2023 were approximately $409,000 and $354,000, respectively. The increase of approximately $55,000 is related to the Company's entering into the final stage of the development of  the next generation STA Single Tooth Anesthesia System.

 

Profit (Loss) from Operations for 2024 and 2023 were as follows:

 

		2024				2023				Change
Dental		$	818,749			$	1,240,884			$	(422,135	)
Medical			(1,019,740	)			(1,685,832	)			666,092
Corporate			(3,044,500	)			(3,175,278	)			130,778
Total loss from operations		$	(3,245,491	)		$	(3,620,226	)		$	374,735

 

The loss from operations was approximately $3.2 million and $3.6 million for the six months ended June 30, 2024 and 2023, respectively, a decrease of approximately $375,000. 

 

Liquidity and Capital Resources

 

Cash Flows

 

The following table summarizes our sources and uses of cash for six months ended:

 

Cash flow:		June 30, 2024				June 30, 2023				Change
Net cash provided by (used in) operating activities		$	(434,473	)		$	(3,027,126	)		$	2,592,653
Net cash provided by (used in) investing activities		$	2,969,977			$	(1,982,376	)		$	4,952,353
Net cash provided by (used in) financing activities		$	238,889			$	(4,324	)		$	243,213

Operating Activities

 

 

Cash flows used in operating activities decreased of $2.6 million for the six months ended June 30, 2024 compared to June 30, 2023. The decrease was primarily driven by the Company’s receipt of approximately $2.0 million, net of expenses, from the sale of New Jersey net operating losses ‘(NOL”), that were eligible for sale under the State of New Jersey’s Economic Development Authority’s  New Jersey Technology Business Tax Certificate Transfer  program (“NJEDA Program”).

 

Investing Activities

 

Cash flows provided by investing activities increased $5.0 million for the six months ended June 30, 2024 compared to June 30, 2023. The increase in cash provided in investing activities was driven by the Company’s purchase of $2.0 million of marketable securities during the six months ended June 30, 2023. The Company sold $3.0 million of marketable securities during the six months ended June 30, 2024 which increased cash and equivalents $3.0 million.

 

Financing Activities

 

Net cash provided by financing activities for the six months ended June 30, 2024 compared to June 30, 2023 increased by approximately $243,000 primarily due to the issuance of additional shares of the Company’s common stock due to a Public Placement Offering.

 

Consideration of Company’s ability to continue as a going concern.

 

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 consolidated financial statements are issued. The Company has incurred total losses since inception of $124.6 million. The operating losses were $1.8 million and $3.2 million, for three and six months ended June 30, 2024. On June 30, 2024, Milestone Scientific had cash and cash equivalents of approximately $5.8 million and working capital of approximately $7.7 million. For the six months ended June 30, 2024, and 2023, we had cash flows used in operating activities of approximately $0.4 million and $3.0 million respectively. 

 

In April 2024, we received approximately $2.0 million, net of expenses, from the sale of New Jersey net operating losses (“NOL”), that were eligible for sale under the State of New Jersey’s Economic Development Authority’s New Jersey Technology Business Tax Certificate Transfer  program (“NJEDA Program”).

 

Management has prepared financial forecasts covering a period of 12 months from the date of issuance of these financial statements. 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 12 months from the filing date. 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. 

 

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

 

Our management, with the participation of our Chief Executive Officer and Principal Accounting Officer, both positions being held by the same person, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2024. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it 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. 

 

Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate, to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, as ours are designed to do, and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on such evaluation, our Chief Executive Officer and Principal Accounting Officer, concluded that, as of June 30, 2024, our disclosure controls and procedures were effective at a reasonable assurance level.

 

Changes in Internal Control over Financial Reporting

 

We routinely review our internal control over financial reporting and from time to time make changes intended to enhance the effectiveness of our internal control over financial reporting. During the three months ended June 30, 2024, we made no changes to our internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, that we believe materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

Item 1A. Risk Factors

 

There have been no material changes to the risk factors previously disclosed in Part I, Item 1A, of our 2023 Annual Report.

 

Item1B. Unresolved Staff Comments

 

None.

 

Item 1C. Cybersecurity

 

None.

 

Item 2. Unregistered Sales of Equity Securities and use of proceeds Item 3.

 

Not applicable.

Default upon Senior Securities

 

Not applicable.

 

Item 4. Mine Safety Disclosure

 

Not applicable.

 

Item 5. Other Information

 

Not applicable.

 

 

Item 6. Exhibits and Financial Statement Schedules

 

Exhibit No		Description
31.1		Rule 13a-14(a) Certification-Chief Executive Officer and Chief Accounting Officer*
32.1		Section 1350 Certifications-Chief Executive Officer and Chief Accounting 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.

 

 

 

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
	Chief Accounting Officer
	Principal Executive Officer
Date: August 14, 2024