Milestone Scientific Inc. (MLSS) is a biomedical technology company that has developed a proprietary, revolutionary, computer-controlled anesthetic delivery device, its DPS Dynamic Pressure Sensing Technology® System. The company's innovative solutions are designed to redefine the worldwide standard of care for injection techniques, making the experience more comfortable for patients and reducing the anxiety and stress of receiving injections for healthcare providers.

Business Overview

Milestone Scientific's flagship product, the STA Single Tooth Anesthesia System, has been used to deliver over 92 million safe, effective, and comfortable injections since its market introduction in 2007. The instrument has been favorably evaluated in numerous peer-reviewed, published clinical studies and is proving to be a valuable and beneficial instrument that is positively impacting the practice of dentistry worldwide.

In addition to its dental offerings, Milestone Scientific has also received FDA clearance for its CompuFlo Epidural Computer Controlled Anesthesia System, which is designed for use in the lumbar, thoracic, and cervical thoracic junction of the spinal region. The company is now focused on advancing its reimbursement strategy and establishing CompuFlo as the new standard of care in epidural anesthesia.

Financials

For the full year 2023, Milestone Scientific reported annual revenue of $9,827,444, a decrease from the previous year's revenue of $10,456,548. The company's annual net income was -$6,929,104, and its annual operating cash flow and free cash flow were -$5,326,129 and -$5,331,010, respectively.

In the first quarter of 2024, Milestone Scientific generated revenue of $2,248,845, a decrease from $2,597,598 in the same period of the prior year. The decrease was largely due to a reserve reversal in the first quarter of 2023, coupled with a decline in international sales during the first quarter of 2024. However, the company's e-commerce sales, which reflect its new online sales portal, achieved growth of 31% over the same period last year.

Gross profit for the first quarter of 2024 was $1,676,103, or 75% of revenue, compared to $1,889,463, or 73% of revenue, for the same period in 2023. The increase in gross profit margin was due to higher margin sales with the launch of the new online store.

Operating losses for the first quarter of 2024 were approximately $1.5 million, compared to $1.3 million for the first quarter of 2023. Net loss for the first quarter of 2024 was approximately $1.4 million, or $0.02 per share, compared to a net loss of $1.3 million, or $0.02 per share, for the same period in 2023.

Liquidity

Milestone Scientific continues to maintain a strong balance sheet, with approximately $5 million in cash, cash equivalents, and marketable securities as of March 31, 2024, and no long-term debt. The company believes this provides sufficient resources to execute on its sales and marketing activities around both its dental and medical instruments without the need for additional capital raises.

Recent Developments

The company's new direct sales strategy, including the launch of its online sales portal in the U.S., as well as its enhanced marketing efforts around the STA, have been effective, as illustrated by the increase in e-commerce sales and the gross profit margin improvement during the first quarter of 2024.

Milestone Scientific's dental business continues to generate positive cash flow on a stand-alone basis, and the company remains focused on achieving its goal of positive cash flow company-wide. On the medical side, the company is making progress advancing its reimbursement strategy around the CompuFlo Epidural System and remains encouraged by the outlook for the business given its sales pipeline, the addition of new pain management clinics, and the expansion of its international distribution partners.

The medical segment represents a large addressable market, and Milestone Scientific remains confident in its belief that CompuFlo will ultimately become the standard of care given both the safety, predictability, and efficiency advantages of the technology. The company is making significant progress in advancing its reimbursement strategy, having submitted over 160 claims to payer systems, including a variety of Medicare jurisdictions, using the specific CPT code for the CompuFlo system.

Milestone Scientific is also expanding its network of distribution partners for CompuFlo internationally, targeting independent distributors with existing relationships within key global markets and a proven track record of introducing medical devices within their territories. The company has also received preliminary indication that CompuFlo has received regulatory approval in one of the largest BRIC countries and expects to report on this further in the near future.

Conclusion

In summary, Milestone Scientific has developed an efficient and scalable platform to help drive high-margin, recurring sales in the coming years, and the company remains committed to driving shareholder value. While the company continues to face challenges, it is making significant progress in advancing its reimbursement strategy and expanding its global footprint, positioning it for long-term growth and success.