Milestone Scientific (MLSS) risk factors, FY2024 10-K

Risks Related to Our Financial Position and Need for Additional Capital

1. 01We have incurred significant losses since our inception. These operating losses are expected to continue, and we are unable to predict the extent of future losses, whether we will generate significant revenues or whether we will achieve or sustain profitability
2. 02We anticipate that we will need additional funding for our operations and may be unable to raise capital when needed, which may force us to delay, curtail or eliminate parts of the Company’s operations
3. 03Sales of a substantial number of shares of our common stock, or the perception that such sales may occur, may adversely impact on the price of our common stock
4. 04Raising additional capital 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
5. 05Changes in financial institutions could adversely affect our current and projected business operations, financial condition and results of operations

Risks Related to Sales and Distribution of Milestone Scientific Products

1. 06Milestone Scientific’s sales and marketing efforts in the United Stated rely upon its E-Commerce platform
2. 07We are exposed to the risks inherent in international sales
3. 08If physicians neither accept nor use our CompuFlo Epidural System, our ability to generate revenue from sales will be materially impaired
4. 09effectiveness of marketing and distribution efforts by us and our licensees and distributors
5. 10Developments by competitors may render our products or technologies obsolete or non-competitive
6. 11Our ability to commercialize our products will depend in part on the extent to which reimbursement will be available from governmental agencies, health administration authorities, private health maintenance organizations and health insurers and other healthcare payers
7. 12We could lose our market advantage earlier than expected

Risks Related to Employee Matters

1. 13We may not be able to attract and retain qualified employees

Risk Related to Our Dependence on Third Parties

1. 14We have limited internal experience in manufacturing operations and have not historically established our own manufacturing facilities. We currently lack the internal resources to manufacture any of our products, including our CompuFlo® Epidural Computer Controlled Anesthesia System
2. 15Contract manufacturers may not perform as agreed or may not remain in the contract manufacturing business for the time required to successfully produce, store, and distribute our products
3. 16If any third-party manufacturer makes improvements in the manufacturing process for our products, we may not own, or may have to share, the intellectual property rights to the innovation. We may be required to pay fees or other costs for access to such improvements
4. 17Our business is exposed to risks associated with the economic, environmental, and political conditions in China because the sole manufacturer of our handpieces is in China
5. 18Issues with product quality could have a material adverse effect upon our business, subject us to regulatory actions and cause a loss of customer confidence in us or our products
6. 19The use of third parties to manufacture our products may increase the risk that we will not have enough of our products or such quantities at acceptable levels of cost and quality, which could impair our commercialization efforts

Risks Related to Regulatory Compliance and Other Legal Matters

1. 20We are subject to substantial domestic and international government regulation, including regulatory quality standards applicable to our manufacturing and quality processes. Failure by us to comply with these standards could have an adverse effect on our business, financial condition, or results of operations
2. 21Once a medical device is permitted to be legally marketed in the United States pursuant to a 510(k) clearance, a manufacturer may be required to notify the FDA of certain modifications to the device
3. 22Changes to United States federal and state regulatory agencies may cause disruptions and delays in approval of the government approval processes and regulation relating to our products
4. 23Milestone Scientific may be subject to enforcement actions if it engages in improper marketing or promotion of its products
5. 24Changes in laws and regulations over which we have no control can significantly affect our business and results of operations
6. 25Changes to trade policy, including tariff and import/export regulations, may have a material adverse effect on our results of operations, cash flows and financial condition
7. 26International conflict has affected commerce worldwide, and may have a material adverse effect on our results of operations, cash flows and financial condition

Risks Related to Milestone Scientific Common Stock

1. 27Milestone Scientific is effectively controlled by a limited number of stockholders
2. 28Failure to implement effective internal controls required by the Sarbanes-Oxley Act of 2002 could result in material misstatements in our financial statements, cause investors to lose confidence in the Company’s reported financial information and have a negative effect on the trading price of our common stock
3. 29change in securities analysts’ estimates of our performance, or our failure to meet analysts’ expectations
4. 30We have never paid and do not intend to pay cash dividends in the foreseeable future. As a result, capital appreciation, if any, will be your sole source of gain
5. 31Provisions in our certificate of incorporation, our by-laws and Delaware law might discourage, delay, or prevent a change in control of our company or changes in our management and, therefore, depress the trading price of our common stock
6. 32All of which could make it more difficult for a third party to acquire, or discourage a third party from seeking to acquire, control of our company
7. 33Your percentage of ownership in Milestone Scientific may be diluted in the future

Risks Related to Our Intellectual Property

1. 34If we are unable to adequately protect our patents, trade secrets and other proprietary rights, if our patents are challenged or if our provisional patent applications do not get approved, our competitiveness and business prospects may be materially damaged
2. 35Third parties may claim that one or more aspects of our technologies or products may infringe on their intellectual property rights

General Business Risks

1. 36Our business and operations would suffer in the event of cybersecurity or other system failures
2. 37Insurance coverage may be inadequate or unavailable to cover any product liability losses we incur