Milestone Scientific(MLSS) - 2024 Q4 - Annual Report

Part I Business Milestone Scientific is a biomedical technology company commercializing its proprietary computer-controlled anesthetic delivery platform for dental and medical markets Overview and Technology Milestone Scientific's core is its proprietary DPS Dynamic Pressure Sensing Technology®, a computer-controlled system for subcutaneous drug delivery - The company's core technology is the proprietary DPS Dynamic Pressure Sensing Technology® System, which regulates flow rate and monitors pressure from the needle tip for various subcutaneous drug delivery injections[8] - The technology provides visual and audible in-tissue pressure feedback, allowing healthcare providers to identify tissue types and prevent injections outside the intended target area, which is crucial for toxic substances like chemotherapeutics[12] - The system is designed to increase safety and efficacy compared to the 160-year-old hypodermic syringe by controlling pressure and flow rate, thus minimizing pain and tissue damage[14][15] Products The company markets two main product lines based on its core technology: the Wand/STA dental system and the CompuFlo® Epidural System - The Wand/STA dental system has been used to deliver over 95 million injections and is viewed favorably in numerous clinical studies[18] - The CompuFlo® Epidural System received expanded 510(k) FDA clearance for use in the thoracic region of the spine, adding to its previous approval for the lumbar region[21] - A technology-specific CPT code (CPT0777T) became effective on January 1, 2023, allowing clinicians to submit claims for reimbursement when using the CompuFlo Epidural System, which is expected to accelerate its commercial rollout in the U.S[20] - The company has secured regulatory approval to market and sell the CompuFlo® Epidural System in Brazil and has established favorable Medicare Part B physician price assignments in Florida and other states[22][23][24] Patents, Manufacturing, and Distribution Milestone Scientific protects its technology with approximately 317 U.S. and foreign patents and relies on third-party manufacturers and a mix of direct and distributor sales - The company holds approximately 317 U.S. and foreign patents and 21 registered trademarks to protect its intellectual property[28] - Manufacturing is outsourced via informal arrangements, with the Wand/STA System made in the U.S. and dental handpieces manufactured in the People's Republic of China[31][32] - In the U.S., dental products are sold directly to end-users through an online e-commerce portal, while medical products are sold through a small direct sales team and a distributor partnership[36][38] Competition and Regulation Milestone Scientific competes with other computer-controlled local anesthesia delivery systems and traditional syringes, and its products are subject to extensive FDA regulation - Key competitors in the dental market include C-CLAD systems like Quicksleeper, SleeperOne, Dentapen, and Calajet, in addition to traditional syringes[41][42][43][44] - In the medical market for epidural space identification, competitors include the EpiFaith Syringe and the Epidrum[45] - The company's products are subject to extensive FDA regulation, requiring 510(k) pre-market notification clearance before commercial distribution in the U.S. and adherence to Quality System Regulation (QSR) standards[48][49][55] Risk Factors The company faces significant financial, operational, and regulatory risks, including a history of losses, reliance on third-party manufacturers, and market acceptance challenges Financial and Capital Risks Milestone Scientific has a history of significant operating losses and requires additional capital to fund its operations and commercialization efforts - The company has a history of significant operating losses, with losses of $6.8 million in 2024 and $7.1 million in 2023, and these losses are expected to continue[59] - Future viability is dependent on the ability to raise additional capital, and failure to do so may force delays or elimination of operations; net cash used in operations was approximately $2.9 million in 2024 and $5.3 million in 2023[61] - The company holds cash deposits exceeding the $250,000 FDIC insurance limit, exposing it to risks related to the financial stability of its banking institution[64] Sales, Distribution, and Market Risks The company's sales depend on its e-commerce platform and international markets, while the medical business's success hinges on physician acceptance and reimbursement availability - A significant portion of sales is expected to come from the E-Commerce platform launched in January 2023 for its STA systems and handpieces in the United States[66] - International sales constituted approximately 40% of total sales in 2024, exposing the company to risks such as currency fluctuations, tariffs, and political instability[67] - Market acceptance of the CompuFlo Epidural System by physicians is critical for revenue generation and is dependent on perceptions of safety, cost-effectiveness, and the availability of reimbursement[69][71] Dependence on Third Parties and Manufacturing Risks Milestone Scientific relies exclusively on third-party manufacturers, particularly a sole supplier in China, creating significant supply chain and geopolitical risks - The company relies exclusively on third parties for manufacturing, with informal arrangements on a purchase-order basis, lacking price protection or supply commitments[77][78] - The sole manufacturer of dental handpieces is in the People's Republic of China, exposing the business to risks associated with U.S.-China trade policy, tariffs, and regional instability[78][83] - Establishing new manufacturing relationships would be expensive and time-consuming, as it would require recovering or producing new tools and software[81] Regulatory and Legal Risks The company is subject to extensive and ongoing regulation by the FDA and international bodies, as well as healthcare fraud and abuse laws, with non-compliance carrying substantial penalties - The company is subject to substantial government regulation, including FDA's Quality System Regulation requirements, and failure to comply could lead to manufacturing shutdowns, recalls, or other penalties[89][90] - Operations are subject to federal and state healthcare fraud and abuse laws, including the Anti-Kickback Statute and False Claims Act, which can result in substantial penalties and exclusion from federal healthcare programs[91] - Changes in U.S. trade policy, including tariffs on goods from China, could increase supply chain costs and adversely impact operations[103] Stock-Related and Intellectual Property Risks The company faces risks related to stock control by a limited number of stockholders, stock price volatility, and the protection or infringement of intellectual property rights - Principal stockholders Leonard Osser and BP4, Srl, control approximately 20% of the outstanding common stock, allowing them to exercise substantial control over corporate actions[107] - Failure to adequately protect patents and other proprietary rights could materially damage business prospects, as intellectual property rights may be challenged, invalidated, or circumvented[117][118] - The company faces risks of third-party claims that its products infringe on other intellectual property rights, which could result in substantial costs, damages, and injunctions against selling its products[121][122][124] Unresolved Staff Comments The company reports that there are no unresolved staff comments - None[129] Cybersecurity The company's Board of Directors, through its audit committee, oversees cybersecurity risk management, with no material incidents reported to date - The board of directors, through the audit committee, has overall oversight responsibility for cybersecurity risks, receiving quarterly reports from management[130] - The company maintains a cybersecurity program that includes risk assessments, employee training, and partnerships with external security service providers for threat detection[131][132] - The company has not identified any cybersecurity incidents or threats that have materially affected or are reasonably likely to materially affect its business, operations, or financial condition[134] Description of Property Milestone Scientific's headquarters is located in a leased facility in New Jersey, and the company does not own any real property - The company's principal executive office is a leased facility in Roseland, New Jersey, with a seven-year lease term that commenced in 2021[135] - The company does not own any real property and has no policy to invest in real estate[136] Legal Proceedings The company reports that it is not involved in any material litigation - Milestone Scientific is not involved in any material litigation[137] Mine Safety Disclosure This item is not applicable to the company - Not applicable[138] Part II Market for Common Equity, Related Stockholder Matters and Small Business Issuer Purchases of Equity Securities Milestone Scientific's common stock is listed on NYSE American, with approximately 97 stockholders, and the company does not anticipate paying dividends Quarterly Stock Price (MLSS) | Period | 2024 High | 2024 Low | 2023 High | 2023 Low | | :--- | :--- | :--- | :--- | :--- | | First Quarter | $0.78 | $0.52 | $1.00 | $0.46 | | Second Quarter | $0.85 | $0.54 | $1.22 | $0.72 | | Third Quarter | $1.10 | $0.58 | $1.35 | $0.81 | | Fourth Quarter | $1.05 | $0.60 | $1.00 | $0.56 | - As of March 27, 2024, the company had approximately 97 stockholders of record and an estimated 3,488 beneficial owners[141] - The company has not paid and does not expect to pay any dividends in the foreseeable future[142] Management's Discussion and Analysis of Financial Condition and Results of Operations Revenue decreased to $8.6 million in 2024, but net loss improved to $4.7 million due to NOL sale and lower expenses, with management confident in future funding Results of Operations Consolidated revenue fell by $1.2 million to $8.6 million in 2024, primarily due to lower international dental sales, while net loss improved to $4.7 million Consolidated Results of Operations (2024 vs. 2023) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Product sales, net | $8,629,928 | $9,827,444 | | Gross profit | $6,434,588 | $6,792,612 | | Total operating expenses | $13,191,545 | $13,899,086 | | Loss from operations | $(6,756,957) | $(7,106,474) | | Gain on sale of net operating losses | $1,983,095 | - | | Net loss | $(4,713,597) | $(6,980,947) | Net Sales by Segment (2024 vs. 2023) | Segment | 2024 | 2023 | Change | | :--- | :--- | :--- | :--- | | Dental | $8,527,108 | $9,761,444 | $(1,234,336) | | Medical | $102,820 | $66,000 | $36,820 | | Total sales, net | $8,629,928 | $9,827,444 | $(1,197,516) | - The decrease in revenue was primarily due to a $756,000 drop in international revenue and a $270,000 decrease in revenue from China; U.S. E-commerce revenue grew from $4.8 million to $5.1 million[171][172] - Selling, general and administrative (SG&A) expenses decreased by approximately $840,000, driven by lower employee salaries, benefits, and marketing expenses[174] - Research and development expenses increased by approximately $157,000 due to the development of the next-generation STA system, a project which has since been delayed[176] Liquidity and Capital Resources Net cash used in operating activities decreased significantly to $2.9 million in 2024, and management believes existing cash and financing will fund operations for the next twelve months Summary of Cash Flows (2024 vs. 2023) | Cash Flow Activity | 2024 | 2023 | Change | | :--- | :--- | :--- | :--- | | Net cash used in operating activities | $(2,919,875) | $(5,326,129) | $2,406,254 | | Net cash provided by (used in) investing activities | $2,966,449 | $(2,972,172) | $5,938,621 | | Net cash provided by financing activities | $233,771 | $2,560,735 | $(2,326,964) | - The decrease in cash used for operations was primarily driven by the receipt of approximately $2.0 million from the sale of New Jersey net operating losses (NOLs)[179] - Management's plans to increase revenues, decrease fees, and delay R&D, combined with existing cash and an $800,000 related party note financing in April 2025, are expected to fund operations for the next twelve months[167] Controls and Procedures Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2024 - Management concluded that as of December 31, 2024, the company's disclosure controls and procedures were effective at a reasonable assurance level[188] - Based on an assessment using the COSO framework, management concluded that the company's internal control over financial reporting was effective as of December 31, 2024[189] Part III Directors, Executive Officers, and Corporate Governance The company's leadership includes Neal Goldman as Interim CEO, with an independent board and established governance committees, and a code of ethics - Neal Goldman serves as Interim Chief Executive Officer and Chairman of the Board, while Leonard Osser is the Vice Chairman; Arjan Haverhals, the former CEO, remains a director[193][197][198][199] - The Board has three independent directors: Michael McGeehan, Benedetta Casamento, and Dr. Didier Demesmin[216] - The Board has standing Audit, Compensation, and Nominating and Corporate Governance committees, each composed of independent directors; Benedetta Casamento is designated as the audit committee financial expert[208][209][211][210] Executive Compensation The company's compensation program includes base salary, bonuses, and equity awards, with detailed pay for Named Executive Officers and significant agreements for key personnel Summary Compensation Table (2023-2024) | Name and Principal Position | Year | Salary | Bonuses | Other Compensation | Total | | :--- | :--- | :--- | :--- | :--- | :--- | | Jan Adriaan (Arjan) Haverhals | 2024 | $350,000 | $478,000 | $53,422 | $881,422 | | Chief Executive Officer | 2023 | $350,000 | $281,853 | $48,412 | $680,265 | | Peter Milligan | 2023 | $70,000 | $100,000 | - | $170,000 | - Leonard Osser has employment and consulting agreements providing for total annual compensation of $400,000 ($200,000 cash, $200,000 in shares) for 9.5 years from May 19, 2021[228][229] - Arjan Haverhals, who retired as CEO on December 31, 2024, entered into a consulting agreement for an annual fee of $350,000, effective January 1, 2025[231] Director Compensation for Fiscal Year 2024 | Name | Stock Awards | Total | | :--- | :--- | :--- | | Neal Goldman | $120,000 | $120,000 | | Benedetta Casamento | $120,000 | $120,000 | | Leonard Osser | $100,000 | $100,000 | | Dr. Didier Demesmin | $100,000 | $100,000 | | Michael McGeehan | $110,000 | $110,000 | | Gian Domenico Trombetta | $100,000 | $100,000 | Security Ownership of Certain Beneficial Owners and Management Directors and executive officers collectively own 12.00% of common stock, with BP4 S.R.L. as the largest beneficial owner, and shares available under the 2021 Stock Option Plan Security Ownership of Major Holders (as of March 15, 2025) | Name of Beneficial Owner | Beneficially Owned Shares | Percentage | | :--- | :--- | :--- | | Leonard Osser | 5,198,813 | 6.73% | | All directors & executive officers as group (6 persons) | 9,264,282 | 12.00% | | BP4 S.R.L | 9,672,192 | 12.52% | Equity Compensation Plan Information (as of Dec 31, 2024) | Plan | Securities to be issued upon exercise | Weighted avg. exercise price | Securities remaining for future issuance | | :--- | :--- | :--- | :--- | | 2021 Stock Option Plan | 3,051,985 | $2.12 | 7,579,778 | Certain Relationships and Related Transactions The company engages in several related party transactions, including purchases from United Systems, royalty and consulting fees, and recent promissory notes issued to directors - The company purchased approximately $1.7 million in handpieces from its principal supplier, United Systems, in 2024[243] - The Director of Clinical Affairs earned approximately $442,000 in royalty fees and $156,000 in consulting fees during 2024[246] - In April 2025, the company received $800,000 in financing through promissory notes issued to directors Neal Goldman, Benedetta Casamento, and Dr. Didier Demesmin; the notes are due in 2028 and are convertible into common stock[252] Principal Accountant Fees and Services Marcum LLP serves as the principal accountant, with all services pre-approved by the Audit Committee, and fees detailed for fiscal years 2024 and 2023 Accountant Fees (Marcum LLP) | Fee Type | 2024 | 2023 | | :--- | :--- | :--- | | Audit Fees | $220,000 | $295,200 | | Tax Fees | $33,000 | $42,000 | | Audit Related Fees | $0 | $0 | | All Other Fees | $0 | $0 | Part IV Exhibits and Financial Statement Schedules This section lists all exhibits filed with the annual report and serves as an index to the financial statements - This section provides a list of all exhibits filed with the annual report, incorporating by reference documents from previous filings where applicable[259] Financial Statements and Supplementary Data Report of Independent Registered Public Accounting Firm Marcum LLP issued a fair opinion on the financial statements, highlighting a critical audit matter regarding the company's going concern ability - The auditor's opinion is that the financial statements are presented fairly in all material respects[270] - A critical audit matter was identified concerning the company's ability to continue as a going concern due to operating losses and negative cash flows; the audit included evaluating the reasonableness of management's plans to mitigate this risk[276][277] Consolidated Financial Statements The consolidated financial statements present the company's financial position, performance, and cash flows, showing a net loss of $4.7 million on $8.6 million revenue in 2024 Consolidated Balance Sheet Data (as of Dec 31) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Total Current Assets | $9,286,554 | $10,794,469 | | Total Assets | $9,797,072 | $11,371,512 | | Total Current Liabilities | $3,744,127 | $3,076,713 | | Total Liabilities | $3,964,372 | $3,359,000 | | Total Stockholders' Equity | $5,832,700 | $8,012,512 | Consolidated Statement of Operations Data (Year Ended Dec 31) | Metric | 2024 | 2023 | | :--- | :--- | :--- | | Product sales, net | $8,629,928 | $9,827,444 | | Gross profit | $6,434,588 | $6,792,612 | | Loss from operations | $(6,756,957) | $(7,106,474) | | Net loss | $(4,713,597) | $(6,980,947) | | Net loss per share (Basic & Diluted) | $(0.06) | $(0.10) | Notes to Consolidated Financial Statements The notes provide detailed disclosures on going concern, accounting policies, segment data, related party transactions, and commitments, supplementing the financial statements Note B: Going Concern and Liquidity The company's history of losses and negative cash flow raises substantial doubt about its going concern ability, but management's plans and recent financing are expected to alleviate this - The company has incurred losses of $6.8 million in 2024 and $7.1 million in 2023, with an accumulated deficit of $128.1 million, raising substantial doubt about its ability to continue as a going concern[289] - Management's plan to alleviate this doubt includes increasing revenues, decreasing professional fees, delaying R&D, and securing an $800,000 related party note financing in April 2025[290] Note K: Segment and Geographic Data The company operates in Dental and Medical segments, with Dental generating $8.5 million in sales and U.S. sales totaling $5.2 million in 2024 Segment Performance (2024) | Segment | Product Sales, Net | Operating Income (Loss) | | :--- | :--- | :--- | | Dental | $8,527,108 | $1,576,042 | | Medical | $102,820 | $(2,057,750) | | Corporate | - | $(6,275,249) | | Total | $8,629,928 | $(6,756,957) | Sales by Geography (2024) | Region | Grand Total Sales | | :--- | :--- | | Domestic: US | $5,200,849 | | International: Rest of World | $3,429,079 | | International: China | $0 | | Total Product Sales | $8,629,928 | Note P: Subsequent Event Subsequent to year-end, the company issued $800,000 in convertible promissory notes to three of its directors - On April 9, 2025, the company secured $800,000 in financing by issuing convertible promissory notes to three directors[388] - The notes are due in 2028, bear interest, and are convertible into common stock at a price no less than $0.50 per share[388]