Milestone Scientific Inc. (MLSS) Q4 2025 Earnings Report, Transcript and Summary

Good day, everyone. Welcome to the Milestone Scientific Inc. Fourth Quarter 2025 Financial Results and Business Update Conference Call. [Operator Instructions] As a reminder, this call is being recorded. It is now my pleasure to turn the floor over to your host, James Carbonara with Hayden IR. The floor is yours.

Thank you, operator. Good day, everyone. Before we begin, please note that today's call will contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are subject to risks and uncertainties that could cause actual results differ materially from those projected. Please refer to our earnings press release as well as our filings with the SEC, including our 2025 Form 10-K for a discussion of these risks. A replay of this call will be available shortly after its conclusion. With that, I'll turn the call over to our CEO, Eric Hines.

Thank you, James, and good morning to everybody, and thank you for joining our call today. When I stepped in as a CEO in August of 2025, the company was in the middle of the quarter and had been operating without a consistent executive leadership team. I found an organization where spending wasn't always tied to revenue generation or clear ROI. And from day 1, we went line by line through every expense,, cut what wasn't moving the needle and made sure every dollar had a purpose. We also chose not to raise capital just to fund that kind of spending. Our shareholders deserve better. Our focus has been on responsible stewardship while building a stronger operating model. Our early priority was understanding the business, restructuring and building the right team. We also invested in organizational structure, building a capable commercial team and strengthening leadership to ensure we have the talent, processes and tools to execute. The restructuring completed in 2025 allows us to move past stabilization and begin to play offense smartly, investing where we see clear returns and staying disciplined and everything else. By Q4, we began that shift to increasing targeted digital marketing and launching initiatives across both business segments that drove early traction. Our dental business remains the company's backbone. Internationally, adoption of the STA, Single Tooth Anesthesia system continues to grow, reflecting the strength of our technology and distribution relationships. We are also pursuing registrations in many other countries, including Japan, India and Mexico, which could open meaningful new markets. Domestically, we see significant room for expansion with still less than 2% of the overall market. The pilot launch of our dental Ambassador program in December sparked renewed engagement. And in January '26, we took it national. We continue executing that program and pursuing international registrations, and we expect to see results from these efforts beginning in the second and third quarters. Turning to the medical side. CompuFlo is increasingly important to our story. This patented system provides real-time pressure feedback to guide precise epidural injections and clinician interest continues to build. We believe CompuFlo represents a transformative growth driver as reimbursement and clinical adoption expand. In 2025, we relaunched commercialization efforts for CompuFlo and advance the foundation for broader adoption, expanding clinician awareness, progressing regulatory and reimbursement efforts and strengthening key account engagement. In February 2026, we introduced our CompuFlo Advisor program, bringing together more than 10 physician partners and a dedicated reimbursement support infrastructure to drive utilization and accelerate adoption. Looking ahead, we are advancing broader Medicare reimbursement, onboarding new distribution partners and pursuing national and local VA channels. These programs position us to translate early traction into meaningful growth over the coming quarters. Turning to the guidance for 2026. We expect total revenue of $9.8 million to $10.2 million, reflecting double-digit year-over-year growth, driven by expanding adoption across both markets. We expect CompuFlo to contribute $500,000 to $600,000 and approximately 400% increase over 2025. Combined with 2025 cost actions, this 2026 top line growth should meaningfully improve operating leverage and significantly reduced cash burn relative to prior year levels. I want to be direct. Our goal is to reach cash flow breakeven in early 2027 and build real lasting value for shareholders. With a stronger organization, clear commercial focus and innovative products at the heart of our business, Milestone Scientific is entering 2026, ready to deliver. I'll now turn the call over to Keisha now for a few reviews of the financials. Keisha?

Thank you, Eric, and good morning, everyone. Let's take a look at our financial performance for the fourth quarter and full year of 2025. For the 3 months ended December 31, 2025 and 2024, total revenue was $2.1 million and $2 million, respectively, an increase of 2.2% or $45,000. Gross profit was $1.5 million, unchanged compared to $1.5 million for the prior year period. Operating loss was $1.1 million, an 89% improvement of $953,000 compared to the operating losses of $2 million in the prior period. Net loss was $1.1 million compared to the net loss of $2 million for the prior period. Turning to the full year. Net sales totaled $9 million, up 4% from $8.6 million in 2024, driven primarily by the growth in international and dental sales. Gross profit remained flat at $6.4 million, reflecting changes in product mix and cost structure. Operating losses for 2025 improved by $1.1 million to $5.7 million, down from $6.8 million in 2024, primarily due to lower SG&A, reduced of dental-related and R&D expense. Net loss was $5.7 million or $0.07 per share, an improvement of $1 million on a dollar base compared to $4.7 million $0.06 per share in 2024. As of December 31, 2025, the company had $1.1 million in cash and debt of $800,000 and a strong working capital position to support continued growth initiatives. With that, I'll -- With that, operator, we can open the floor for questions.

[Operator Instructions] Your first question is coming from Bruce Jackson with Benchmark Co.

You mentioned that with -- I think it was CompuFlo, you've put in place some reimbursement support with the doctors. Maybe you could elaborate on that a little bit more.

Thanks, Bruce, and good to hear from you. So yes, so one of the things that I observed even in the past as a shareholder is that we really didn't have the infrastructure in place to sort of shotgun the CompuFlo out globally. And so what we've done as part of the Advisor program is we have put a very robust group of individuals, in fact, 2 consultants Evelyn Gittinger and [ Rhonda Turner ], both 20-plus year Medicare veterans, who will be supporting our doctors that are part of the Advisor program with reimbursement claims and so forth as they start to initiate that process. So not only that, we've also got a call center, dedicated call center with 3 to 4 people that will be also helping the offices deal with rebuttals and so forth from a claims perspective. So we've got a good team with a lot of experience who will be helping the doctors through that process.

Okay. Great. And then 1 more reimbursement question. Are you still currently in 3 of the MACs?

We are.

And then the idea is to go more deeply into those 3 regions and then consider expanding from there?

Yes. So the focus will be on Novitas and First Coast in those 3 respective regions. However, we are already into, I believe, 2 additional MACs that we are -- that are part of Advisor program. So we are going to be pushing down and pressing down hard on the First Coast of Novitas MACs, but also expanding into others.

Okay. And then last question for me. The gross margins had a nice little tick up this quarter. Is that something that's going to be sustainable going forward?

I'm going to turn that over to Keisha. I think we're more or less going to be consistent with the gross margins. I think we'll stay in the 70% range is kind of the plan.

Yes, that is our plan. However, with issues of tariffs and anything like that might arise, we still have to look at all of those options to make sure that we are putting in accruals and different things like that, but we have not been affected totally with tariffs or anything like that at this time.

Your next question is coming from Anthony Vendetti with the Maxim Group.

Yes, Eric, I was just wondering the guidance for the CompuFlo, for the Epidural System for pain management. Is -- are there specific milestones you need to reach or specific number of pain clinics or physicians using it to get to that? How much of that is -- how that guidance is from current signed up clinics or physicians? And then how much of that do you need to actually go out and procure?

That's a great question. So it will be a combination of a handful of things, right? So it will be -- I'm going to say 3 different things, right? First and foremost, it will be the existing customers, right? We've got 1 of our Board members Dr. Demesmin, whose clinic and others within that group use the solution. And we've got several that were generated under the prior administration. We also have added quite a number of new physicians, and we're finding that the adoption rate is maybe a little bit higher than even we expected because people that get it, get it and see the value even in spite of some of the Medicare challenges right at this moment. And then the third is international, right? So we've got sort of 3 components to that. But right now, we are seeing quite an appetite for people and for new customers, embracing the units. And I think you'll see that reflected in our Q1 highlights at some point.

Okay. And then switching gears to the dental program. you launched a new program, the Wand Ambassador program. How does that differ from any other marketing strategy the company has had in the past? And what specific KPIs do you need to hit? Or do needs to occur for that to be deemed successful for '26?

Yes. No, another good question. So how it differs is historically, we've got a relatively small inside sales team who chases the dental business. So we've got 1 person who focuses on the installed base and another person that's focused on new business. And we've really fortified sort of our digital marketing tremendously to the point that we're seeing so many leads come in that it's a tough time for us to sort of keep up with the staff we have to do the demos. So the Ambassador program is a little bit more of a local push. So I believe that as of now, we've signed up nearly 200, I think, about 175 ambassadors nationally, which include, I don't know, maybe 20 or 30 states, and so the point there is that we get people out physically in the marketplace talking with expertise because these are registered for the most part, dental hygienists, until we get people out in the community who know the doctors in their respective communities out visiting offices, in some cases, in a physical way. And in other cases, them using some of our own content to broadcast the great things about the Wand STA on their own social media channels. So it's really an effort to get out into the physical market, more so than relying on inside sales and relying on digital marketing. We've generated, I think, close to 30 demos as a result of it so far. And again, there's a certain percentage of those that translates into new sales. So as far as what we expected to contribute in 2026, the goal is somewhere in the neighborhood of a few hundred thousand dollars of new sales as a result of the Ambassador program. And more recently, I think in the next -- in the coming days, we have -- I don't know if it's like a refresher, but we have monthly meetings with our entire ambassador staff, they're sort of giving them FAQs, what's working, what's not working, who's having success, what content seems to be working. So it's still a little bit new, but at the same time, we're pretty happy with the results of thus far.

Okay. And then on the guidance, I think the total guidance is $9.8 million to $10.2 million. Obviously, most of that is the dental program, the STA. You mentioned you're looking at other international opportunities in Japan, Mexico, India. Is -- does the guidance include any revenue from those new countries? Or is the guidance -- or if you start generating revenues in 1 of those other countries in '26, that would be upset.

Yes, the numbers don't contemplate any business from Mexico, India or Japan at this moment that -- we're still waiting for the final registrations to be approved. We're 85%, 90% of the way through those, but it's up to each individual country to work through their respective systems to get us the official registration. But we're pretty far along in each of them. We had expectations that we might 1 or 2 in the first quarter, but we're probably a couple of months. So we'll see. We hope that will be accretive to the guidance.

Okay. Great. And then last question, just switch back to the CompuFlo. So I know one of the reasons that the focus has moved to the pain clinics versus the hospitals for OB/GYN. For CompuFlo, the hospitals are a much longer sales cycle, tougher to penetrate and get traction as a small company and the pain clinics are a little bit faster conversion cycle in terms of marketing to them and seeing the benefits and hopefully, getting a sale. Is -- do you have a -- at this point, a good grasp on how long that takes? How long is the sales cycle for the pain clinics. And is there any way to shorten that at this point?

Yes. No, we've seen sales cycles as short as a day, right? I mean, so -- and I don't think that we're just missing OB/GYN, neurosurgery, what we're finding is we're still kind of a little bit in the discovery phase where we pivoted from labor and delivery over to pain. We're not convinced or at least I'm not convinced that this -- the CompuFlo doesn't have an opportunity to penetrate all respective markets. Again, we want to do our best to be focused. On the other hand, we're -- we don't want to completely walk away from things where we think there's huge potential. I mean, labor and delivery being one of those, right? Because there, the doctors going blind with no fluoroscopy. And when you get into more complex cases and neurosurgery up in the cervical spine and even the thoracic, you've got ribs in the way that compromise the x-ray. So it makes it more difficult for them in more difficult cases. We're seeing spinal stimulation opportunities. So we haven't completely dismissed any of the markets. We want to remain focused on pain, and we're seeing sales cycles like I said, that can -- anywhere from a few days, right? I'll just give a shout out to 1 of our great Board members, Dr. Sayed, who's been tremendously helpful in introducing us to lots of people within that community.

[Operator Instructions] your next question is coming from John [ Corb ], a private investor.

Eric. I have a very short comment. As you may know or remember from our last quarterly call, I'm a long-term shareholder, been a shareholder for many years with Milestone. First of all, I really like the way you are handling this company since you came on Board. And there's -- the last line in your comment or your written comment yesterday, I don't think I've ever read anything like this from Milestone. Our objective is clear: position the company to achieve cash flow breakeven by early '27. That's extremely focused. I've asked in the past, when will you be cash flow neutral positive and the answers were always nebulous. You're extraordinarily focused, and I'm greatly encouraged by your stewardship at Milestone. So I just want to thank you for your efforts.

John, I appreciate that, and I couldn't do any of this without Keisha. She's sitting here with me, and she's tough, right? And we, together as a team are going to ensure that we -- every money -- every cent that comes into this company is going to be used in the right way. And as a former shareholder and current shareholder like yourself, a lot of us were discouraged by the way the company was handling some of that. And I can promise you, we're going to do everything we possibly can to get to cash flow breakeven. And as I pointed out in the conversation we had moments ago, we are not going to take money and send it toward bad situations. And the money that we receive or that comes into the company will be used in a very judicious way. And if we can't get to breakeven next year, I'll be disappointed.

[Operator Instructions] There are no questions in queue at this time. I would now like to turn the floor back over to Eric Hines for any closing remarks.

I just want to thank everybody for joining, and we greatly appreciate all of our shareholders. This is going to be a shareholder-driven company here until I'm gone. Hopefully, that's not for a long time. And I'm looking forward to a great 2026. And I hope everyone has a happy and healthy week ahead of them, and good luck to all of us and thank you Kelly and thank you, James, for managing the call, and good luck. Thank you.

Thank you, everyone. This does conclude today's conference call. You may disconnect your phone lines at this time, and have a wonderful day. Thank you for your participation.