Milestone Scientific Reports Financial Results for Third Quarter 2026

Milestone Scientific narrows losses, cuts costs, and targets profitability by year-end.

What the company is saying

Milestone Scientific reports progress toward profitability, emphasizing $400,000 in expected annual cost savings and a debt-free balance sheet after converting director loans to equity. The company highlights expanded clinical adoption of its CompuFlo technology, including new use at Rothman Orthopaedics and Pain and Spine Specialists, and a pipeline of over 500 U.S. commercial leads supported by a growing sales force and distribution network. Management frames the CompuFlo opportunity as substantial, citing a peer-reviewed study showing 91% lower odds of complications and an illustrative $33 million annual revenue potential at 2% U.S. market penetration, though this is not a forecast. CEO Eric Hines attributes the recent revenue dip to seasonality and the absence of large international orders that benefited the prior quarter, while noting improved customer engagement and a scalable sales process. The company reaffirms its 2026 revenue outlook of $9.8–$10.2 million and expects to reach or approach profitability in Q4 2026, with lower losses projected for 2027. International expansion efforts are underway in Italy and Greece, and a provisional patent has been filed for a new CompuFlo application.

What the data suggests

For Q3 2026, revenue declined 5.9% year-over-year to $2.2 million, mainly due to lower dental product sales, partially offset by growth in medical sales and dental repair income. Gross profit for the quarter was $1.6 million, with gross margin improving to 72.3% from 69.5% a year earlier, reflecting lower product costs. Operating expenses dropped by $424,000 (15.3%) to $2.4 million, driven by reductions in compensation, professional fees, and contract-related costs, though marketing and regulatory expenses rose. Net loss narrowed to $748,000 ($0.01 per share) from $1.2 million ($0.01 per share) in Q3 2025. For the nine months ended September 30, 2026, revenue rose 4.4% to $7.2 million, gross profit increased to $5.1 million, and operating expenses fell by $2.0 million (20.9%) to $7.5 million. Nine-month net loss improved to $2.5 million ($0.03 per share) from $4.6 million ($0.06 per share) in the prior year. Cash at quarter-end was $1.3 million, with $3.5 million in working capital and no debt. Management reiterates that quarterly revenue of $2.6–$2.7 million would bring the company near profitability. The $33 million annual revenue scenario is hypothetical and not supported by current penetration. The company’s financial trajectory is improving, with cost controls and margin gains evident, but profitability remains a forward target.

Analysis

The announcement is upbeat, highlighting cost reductions, clinical adoption, and a pathway to profitability. The company provides detailed realised financials, including narrowing net losses, improved gross margin, and reduced operating expenses, which support a positive operational trend. However, several key claims are forward-looking, such as the expected $400,000 in annual savings, the reaffirmed revenue outlook, and the projection of reaching profitability in Q4 2026. The illustrative $33 million revenue scenario is explicitly not a forecast and is not supported by current penetration rates. While the tone is optimistic, the realised progress is incremental rather than transformative, and the company's core business remains loss-making. The gap between narrative and evidence is most pronounced in the discussion of market opportunity and future profitability, which are not yet realised.

Risk flags

• ●Milestone Scientific remains loss-making, with a Q3 2026 net loss of $748,000 and a nine-month net loss of $2.5 million, so the path to sustained profitability is not yet proven. If revenue growth stalls or cost savings are not fully realized, losses could persist.
• ●The company’s revenue outlook and profitability hinge on converting a pipeline of over 500 U.S. commercial leads into active accounts and increasing procedure volumes. Failure to achieve sufficient adoption or market penetration, especially for CompuFlo, would undermine the business case.
• ●Cash and cash equivalents stood at $1.3 million as of September 30, 2026, which is a limited cushion relative to ongoing losses. If profitability is not reached as projected, additional capital may be required.
• ●The $33 million annual revenue scenario is illustrative and not a forecast; actual U.S. market penetration is not disclosed, so the scale of future recurring revenue remains uncertain.
• ●International expansion efforts in Italy and Greece are at the distributor engagement and market development stage, with no quantified sales or contractual commitments yet, making the timing and impact of overseas growth unclear.

Bottom line

Milestone Scientific is making tangible progress on cost control and margin improvement, with operating expenses down 20.9% year-to-date and net losses narrowing both quarterly and year-to-date. The company is debt-free and has a clear near-term target: reaching profitability in Q4 2026 if quarterly revenue can be lifted to $2.6–$2.7 million. The core risk is that revenue growth, especially from CompuFlo adoption, may not materialize at the required pace, and current cash reserves are limited. The $33 million revenue scenario is hypothetical and should not be mistaken for a forecast. Investors should focus on realised revenue growth, conversion of the sales pipeline, and evidence of recurring disposable revenue in the next quarter. The most important takeaway is that while the trajectory is improving, profitability and cash sufficiency are not yet secured.

Announcement summary

(NYSE:MLSS) Milestone Scientific Inc. provided a business update and announced financial results for the three and nine months ended September 30, 2026. The company identified cost-reduction initiatives expected to generate approximately $400,000 in additional annual savings, aiming to strengthen its path to potential profitability in Q4 2026 and additional profitable quarters in 2027. Milestone expanded CompuFlo® clinical adoption, including the initiation of clinical use at Rothman Orthopaedics and the addition of Pain and Spine Specialists, a 22-location Northeastern U.S. pain management network, to the CompuFlo Advisor Program. The company built a pipeline of more than 500 U.S. commercial leads, supported by five dedicated medical sales professionals, approximately 15 sales consultants, and three distribution partners, with federal market access through Red One Medical. A peer-reviewed 79-patient University of Texas Medical Branch study associated CompuFlo-guided epidural access with approximately 91% lower adjusted odds of composite complications compared with conventional techniques. The company highlighted an estimated 30 million-plus annual epidural procedures worldwide, including more than 11 million in the U.S., and stated that just 2% U.S. penetration could represent approximately $33 million in annual disposable revenue at $150 per procedure (illustrative only; not a revenue forecast). Milestone submitted a provisional patent application for a new application of CompuFlo technology in intrathecal pump refills. International commercialization efforts included distributor engagement and market development activities in Italy and Greece. The company achieved a debt-free balance sheet by eliminating outstanding director loans through a debt-to-equity conversion. For the three months ended September 30, 2026, total revenue was $2.2 million, compared to $2.4 million for the same period in 2025, a decrease of $140,000 or 5.9%. Gross profit for the three months ended September 30, 2026 and 2025 was $1.6 million. Gross margin was 72.3% for the three months ended September 30, 2026 compared with 69.5% for the same period in 2025. Operating expenses decreased by $424,000, or 15.3%, to $2.4 million for the three months ended September 30, 2026, compared with $2.8 million for the three months ended September 30, 2025. Net loss was $748,000, or ($0.01) per share, compared to a net loss of $1.2 million, or ($0.01) per share, in the prior year period. For the nine months ended September 30, 2026 and 2025, total revenue was $7.2 million and $6.9 million, respectively, an increase of $307,000 or 4.4%. Gross profit for the nine months ended September 30, 2026 and 2025 was $5.1 million and $4.9 million, or 70.3% and 70.9% of revenue, respectively. Operating expenses decreased by $2.0 million, or 20.9%, to $7.5 million for the nine months ended September 30, 2026, compared with $9.5 million for the nine months ended September 30, 2025. Expenses under an existing agreement decreased to approximately $91,000 from approximately $351,000 in the prior-year period. Net loss for the nine months ended September 30, 2026 was $2.5 million, or $(0.03) per share, compared to a net loss of $4.6 million, or $(0.06) per share, for the comparable period in 2025. As of September 30, 2026, the company had cash and cash equivalents of $1.3 million, working capital of $3.5 million, and $0 debt outstanding. Management reaffirmed its full-year 2026 revenue outlook of $9.8 million to $10.2 million. The company expects CompuFlo® medical business revenue to grow at a faster rate than overall company revenue. Management expects the company to approach or achieve profitability in the fourth quarter of 2026 and expects considerably lower losses in 2027 compared with 2026, with additional profitable quarters depending on revenue levels. Quarterly revenue of approximately $2.6 million to $2.7 million would bring the company near its profitability threshold.

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