Company Overview
Milestone Scientific Inc. is a pioneering biomedical technology company dedicated to redefining the standard of care for injection techniques. With a strong focus on developing innovative, computer-controlled drug delivery instruments, Milestone Scientific has established itself as a trailblazer in the medical and dental industries.
The company’s origins can be traced back to its inception in August 1989, when it was incorporated in the state of Delaware. From the outset, Milestone Scientific has been driven by a singular vision: to create solutions that enhance patient comfort and safety while delivering precise and efficient drug delivery.
Technology and Products
At the heart of Milestone Scientific’s technology lies its proprietary DPS Dynamic Pressure Sensing platform. This groundbreaking system regulates the flow rate and monitors the pressure from the tip of the needle, enabling healthcare practitioners to achieve unparalleled precision and control during various subcutaneous drug delivery procedures, including dental and medical injections. The DPS technology has been developed to meet the needs of various subcutaneous drug delivery injections and fluid aspiration, offering multiple unique benefits that cannot be accomplished with the 160-year-old manual syringe.
One of Milestone Scientific’s flagship products, the STA Single Tooth Anesthesia System, has been widely adopted in the dental industry. Leveraging the DPS technology, this innovative device has been used to administer over 92 million safe and comfortable injections worldwide since its market introduction in 2007. The company’s dental products are currently sold in the United States, Canada, and more than 41 other countries, showcasing the global reach and recognition of Milestone Scientific’s solutions. The dental devices are marketed under the trademarks CompuDent and STA Single Tooth Anesthesia System, and utilize The Wand, a single-use disposable handpiece suitable for all dental procedures that require local anesthetic.
In addition to its success in the dental market, Milestone Scientific has also made significant strides in the medical realm. In June 2017, the company received FDA clearance for the sale of its CompuFlo Epidural Computer Controlled Anesthesia System in the United States. This groundbreaking device, which utilizes the DPS technology, provides real-time pressure feedback to assist healthcare practitioners in precisely identifying the epidural space during regional anesthesia procedures. Additionally, certain of the company’s medical instruments have obtained European CE mark approval, allowing them to be marketed and sold in most European countries.
Intellectual Property
Milestone Scientific’s commitment to innovation has not gone unnoticed. The company currently holds over 245 U.S. and foreign patents, with many more patents pending and patent applications in the works. These comprehensive intellectual property protections underscore Milestone Scientific’s dedication to advancing its technological capabilities and maintaining a competitive edge in the market. The company’s patents and patent applications cover a wide range of areas, including 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 devices.
Financials
The company’s financial performance has shown signs of progress, despite the challenges posed by the ongoing global pandemic. For the fiscal year ended December 31, 2023, Milestone Scientific reported total revenue of $9.83 million, a 12% increase compared to the previous year. Gross profit for the same period also saw a 39% increase, reaching $6.79 million. These figures demonstrate the resilience and potential of Milestone Scientific’s business model.
Looking ahead, Milestone Scientific remains focused on expanding the commercial rollout of its CompuFlo Epidural System, particularly in the United States. The company has made significant strides in securing favorable Medicare reimbursement coverage for the device, which is a crucial factor in driving broader adoption among healthcare providers.
In the third quarter of 2024, Milestone Scientific reported a 22% year-over-year increase in total revenue, reaching $2.5 million. This growth was primarily driven by a robust performance in the company’s dental segment, where international sales saw a 57% increase compared to the same period in the previous year.
The company’s net income for the most recent fiscal year (2023) was -$6.93 million, with operating cash flow and free cash flow both at -$5.33 million. For the most recent quarter (Q3 2024), net income was -$1.46 million, with operating cash flow and free cash flow both at -$0.97 million.
In terms of geographic performance, for the first 9 months of 2024, US e-commerce and dental service revenue was $3.9 million, while international revenue was $2.7 million, a decrease of $0.6 million compared to the prior year period. The company did not record any revenue from China in 2024 compared to $270,000 in the prior year.
Liquidity
Milestone Scientific’s balance sheet remains strong, with $4.8 million in cash and cash equivalents and no long-term debt as of September 30, 2024. This financial flexibility positions the company to continue investing in its research and development efforts, as well as its marketing and commercialization initiatives. The company’s debt-to-equity ratio is 0, and it has no credit facilities or credit lines disclosed. The current ratio stands at 2.85, while the quick ratio is 1.86, indicating a healthy short-term liquidity position.
Segment Performance
Milestone Scientific’s dental segment continues to be the primary driver of the company’s revenue. In the three months ended September 30, 2024, the dental segment generated $2.47 million in net sales, an increase of $413,120 compared to the same period in 2023. Gross profit for the dental segment was $1.79 million, an increase of $276,250 year-over-year. Selling, general, and administrative expenses for the dental business were $856,860, down $77,620 from the prior year quarter.
For the nine months ended September 30, 2024, the dental segment recorded net sales of $6.54 million, a decrease of $1.01 million compared to the same period in 2023. Gross profit was $4.86 million, down $517,800 year-over-year. The decrease in dental revenue and gross profit over the nine-month period was primarily due to lower international sales, partially offset by the growth in the company’s e-commerce platform, which launched in January 2023.
The medical segment, centered around the CompuFlo Epidural Computer Controlled Anesthesia System, represents a smaller but growing portion of the business. In the three months ended September 30, 2024, the medical segment generated $47,400 in net sales, an increase of $41,400 compared to the same period in 2023. Gross profit for the medical business was $43,980, up $56,540 year-over-year.
For the nine months ended September 30, 2024, the medical segment recorded net sales of $73,820, an increase of $63,820 compared to the same period in 2023. Gross profit was $66,050, down $159,210 year-over-year. The company continues to focus on expanding the adoption of the CompuFlo Epidural System, both in the United States and internationally.
Challenges and Risks
While Milestone Scientific has demonstrated impressive progress, the company is not without its challenges and risks. The highly competitive nature of the medical and dental device markets, coupled with the regulatory hurdles faced in obtaining necessary approvals, pose ongoing challenges for the company.
Additionally, Milestone Scientific’s reliance on third-party manufacturers and distributors presents supply chain and distribution risks that must be carefully managed. The company’s ability to maintain and expand its global footprint is also subject to geopolitical and macroeconomic uncertainties.
The company has faced challenges in the medical segment with slow adoption of the CompuFlo system. However, it recently received favorable Medicare reimbursement coverage in several regions, which is expected to drive increased adoption.
Management Changes
Arjan Haverhals, the CEO, announced his retirement effective December 31, 2024. He will continue to serve on the Board of Directors and provide consulting services to ensure a smooth transition.
Outlook and Conclusion
Milestone Scientific’s innovative technology, robust intellectual property portfolio, and growing commercial presence position the company as a key player in the evolving landscape of painless and precise drug delivery solutions. As the company continues to drive the adoption of its CompuFlo Epidural System and maintain its leadership in the dental market, investors will be closely watching for further advancements and financial milestones.
The company is confident in its ability to drive further adoption of its CompuFlo Epidural System in the U.S. and international markets. Milestone Scientific is making progress on advancing its reimbursement strategy for the CompuFlo system, including discussions to expand coverage to additional JMAC regions. The company expects its e-commerce dental business to continue to show steady growth in the domestic market.
Despite the challenges, Milestone Scientific’s unwavering commitment to enhancing patient comfort and safety, as well as its track record of technological innovation, suggest a promising future for the company. As it navigates the evolving healthcare landscape, Milestone Scientific appears poised to play a pivotal role in redefining the standard of care for injection techniques worldwide.
The company believes it has sufficient cash and resources to support the growth of both its dental and medical divisions without needing additional outside capital. With its strong liquidity position and ongoing focus on expanding its product offerings and market presence, Milestone Scientific is well-positioned to capitalize on the growing demand for advanced drug delivery systems in both the dental and medical fields.
Disclaimer: This article is for informational purposes only. It does not constitute financial, legal, or other types of advice. While every effort has been made to ensure the accuracy of the information presented here, the author and the publisher do not make any guarantees about the completeness, reliability, and accuracy of this information.