Milestone Scientific Inc. (MLSS) Q3 2025 Earnings Report, Transcript and Summary

Greetings, and welcome to the Milestone Scientific Third Quarter 2025 Financial Results and Business Update Call. [Operator Instructions] And please note, this conference is being recorded. I will now turn the conference over to your host, Mr. David Waldman. Sir, the floor is yours.

Thank you. Good morning, and I appreciate everyone joining Milestone Scientific's Third Quarter 2025 Financial Results Conference Call. On the call with us today are Eric Hines, Chief Executive Officer; and Keisha Harcum, Vice President of Finance of Milestone Scientific. The company issued a press release yesterday after market containing third quarter 2025 financial results, which is also posted on the company's website. If you have any questions after the call or would like any additional information about the company, please contact Crescendo Communications at (212) 671-1020. The company's management will now provide prepared remarks reviewing the financial and operational results for the third quarter ended September 30, 2025. Before we get started, we would like to remind everyone that during this conference call, we may make forward-looking statements regarding timing and financial impact of Milestone's ability to implement its business plan, expected revenue and future success. These statements involve a number of risks and uncertainties and are based on assumptions involving judgments with respect to future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond Milestone's control. Some of the important factors that could cause actual results to differ materially from those indicated by the forward-looking statements are general economic conditions, failure to achieve expected revenue growth, changes in our operating expenses, adverse patent rulings, FDA or legal developments, competitive pressures, changes in customer and market requirements and standards and the risk factors detailed from time to time in Milestone's periodic filings with the Securities and Exchange Commission, including, without limitation, Milestone's report on Form 10-K for the year ended December 31, 2024, and Milestone's report on Form 10-Q for the third quarter ended September 30, 2025. The forward-looking statements made during this call are based upon management's reasonable belief as of today's date, November 14, 2025. Milestone undertakes no obligation to revise or update publicly any forward-looking statements for any reason. With that, I'll now turn the call over to Eric Hines, CEO of Milestone Scientific. Please go ahead, Eric.

Thank you, David. So good morning, folks, and thank you for all joining our call. We're very fortunate to have so many people who believe in Milestone Scientific, and we are making progress. During the third quarter, we continued to execute our plan to build a leaner, more focused organization capable of sustainable growth and improved profitability. Through disciplined cost management and operational restructuring, we reduced operating expenses by over $0.5 million compared to the same period last year, while maintaining stable revenue performance. These results reflect the early benefits of our transformational strategy, which is centered around 3 priorities: streamlining operations and driving efficiency, strengthening commercial execution in both dental and medical and advancing our reimbursement and payer strategy to position CompuFlo for broad adoption in pain management. In our Dental segment, we made solid progress, expanding our direct sales programs in North America and advancing international registrations for our STA Single Tooth Anesthesia System. We have also enhanced our omnichannel marketing capabilities, and our maturing e-commerce platform continue to drive brand visibility and recurring customer engagement. International dental sales increased year-over-year, partially offsetting the decline in domestic revenue. On the Medical side, utilization of CompuFlo disposables rebounded slightly as we are starting to reenergize current customers, ensuring them that we are even more committed than ever as we continue to work on a structured and supported Medicare reimbursement strategy. We are particularly encouraged by feedback from leading pain centers domestically and internationally that are using CompuFlo to improve accuracy, safety and building confidence in epidural procedures. We also strengthened our organization through the addition of Dr. Dawood Sayed to our Board of Directors. Dr. Sayed is one of the country's foremost experts in interventional pain management and serves as Division Chief of Pain Medicine at the University of Kansas Medical Center. His appointment deepens our clinical and payer expertise and supports our strategy to accelerate adoption within hospital systems in integrated pain networks. In parallel, we continue to advance our reimbursement strategy for CompuFlo. And as we discussed last quarter, the system has secured Medicare payment rate assignments under CPT Code 0777T in 3 jurisdictions, supported by 2 MACs, Novitas and First Coast, that includes large population states like New Jersey, Texas and Florida. We are now building on that foundation, engaging with additional payers and expanding our commercial coverage footprint, essential steps for long-term medical growth. In summary, Q3 reflects disciplined execution and tangible progress toward our operational and commercial goals. We are in a more efficient organization. Our cost structure is leaner and our strategic priorities are sharply focused on growth and profitability. I'd also like to just point out that we'd like to invite you all to join our Instagram, Facebook and TikTok pages. Our Instagram page is @the.wan.sta. Our Facebook handle is just the Wan STA. And our TikTok handle is @the.wan.sta. We continue to put tremendous energy into our omnichannel digital marketing strategy, and we believe that will drive more people to understand who we are as an organization. With that, I would like to turn it over to Keisha Harcum.

Thank you, Eric. For the 3 months and the 9 months ended September 30, 2025, revenue was $2.4 million and $6.9 million, respectively, compared to $2.5 million and $6.6 million for the same period in 2024. Gross profit for the 9 months ended September 30, 2025, and 2024, was approximately $4.9 million for each period, reflecting no material year-over-year change. The stable growth performance primarily resulted from consistent product margins, favorable manufacturing cost management and a balanced sales mix between domestic and international markets. For the 3 months and 9 months ended September 30, 2025, SG&A expenses were $2.7 million and $9 million, respectively. Research and development expense for the same period was $16,000 and $437,000, respectively. Operating expenses were approximately $1.1 million and $4.6 million for the 3 and 9 months ended September 30, 2025, respectively. As of September 30, 2025, Milestone Scientific had cash and cash equivalents of approximately $1.3 million, and working capital of approximately $3.1 million. That concludes my financial review. I'll now turn the call back over to Eric.

Thank you, Keisha. As we move forward, our focus remains clear: to execute efficiently, grow revenue and position Milestone for long-term profitability. We are strengthening our sales infrastructure, enhancing customer engagement and advancing the commercial rollout of CompuFlo through partnerships, payer engagement and medical education. In Dental, we continue to leverage our strong brand and product differentiation to drive international growth and expand the recurring revenue through our direct and e-commerce channels. I'm really proud of the progress we've made in such a short time, reducing expenses, stabilizing revenue and advancing the foundation for future growth. The path forward is about disciplined execution, operational excellence and ensuring that we continue to build value for our shareholders, customers and patients worldwide. I can't thank you all enough for joining this call today, and we will now open the lines for questions.

[Operator Instructions] Our first question is coming from Anthony Vendetti with Maxim Group.

So Eric, it sounds like you're very focused on stabilizing the business, which obviously is something that has to be done when you first come in. And in terms of the Dental business, which still obviously drives the vast majority of the revenue. In this particular environment that we're in economically and Dental offices, Dental clinics have always been, I think, and just in my experience, very concerned about investing new capital or buying new equipment. How do you convince them that this is a must-have product? And also if you could talk about the clinics that you're currently in, is there a target utilization rate or a way to ensure a certain level of utilization of your STA unit?

Thanks, Anthony. No, those are great questions. And the Dental business is the foundation for the company, right? At the end of the day, 80 or 90 or even maybe higher than that percentage of the revenues come from the Dental business. What we are learning is that there's really 3 tiers of customers who are sort of low users, mid and high users. And we really believe that a big challenge for us in the marketplace in general is that when we moved over to the direct sales, the e-commerce model, a lot of customers felt that we had really sort of gone more or less out of business and didn't know a whole lot about us. And so we are spending a lot of time really reconnecting with old customers who maybe thought that we didn't exist anymore. But more importantly, really sort of starting to expand our digital marketing to start to get to more dentists because a lot of times when we talk to dentists just in my hometown and what Jason speaks to them in Dallas, they don't even really know about the company or the Wand in general. So we think with 1.5% to 2% of the market share in the domestic market and more or less the same internationally, that it's mostly about getting the word out and really telling people about the benefits of the Wand. On the other side, education, right? So to move the low end users to the high-end users. Typically, we find that the high-end users are spending about $2,500 to $3,000 per year with us on disposables. We need to get the others moving in that direction. And just by the nature of the name of the unit, the STA, the single tooth anesthesia. What we've learned is many people are not using it for all the other injection types. And I think as most of the people know on this call, the Wand can do all of the injection types that a dentist needs during the course of operating their clinic. So we really need to do a better job of educating the low- and mid-tier users to make sure that they understand, and it's clear that the Wand can be used for many more procedures than just single tooth. I don't know if that covers what you asked me, Anthony, but let me know.

Yes. No, that's great. So there's an active effort to try to increase the utilization of the Wand within the current installed base as well as getting the word out. And like you said, there's a huge opportunity because you don't have a lot of penetration at this time, even though it's the vast majority of your business. On the Medical side, maybe I know you decided to refocus on the current clinics that are using it and building that base for broader commercialization. Can you tell us where the company is with that refocused effort and then the plan for broader commercialization? Is that something that's occurring in this quarter? Or is that more of a 2026 goal?

No, another good question, Anthony. And let me just want to one more thing on the dental. So Jason brought to me 11 objectives that he has for the Dental business moving forward from a sales perspective. So along with the education and so forth, we've got objectives to go after some of the dental schools. We've got the DSOs that are part of that mix. We've got the digital marketing to existing customers. We've got lists from our own distributors that we're now starting to go through and have discussions with those folks. So it's a kind of a multitiered program on the dental side that attacks 10 or 11 different objectives, including DSOs. But to answer your question on CompuFlo, and as I stated in the last conference call, what I felt when I stepped into this role is that we had a lot of things going in a lot of different directions. And really, the plan now is to focus our energy on a handful of states, a handful of jurisdictions but more importantly, to put the right structure in place to support the physicians once they start using CompuFlo. And even more importantly, is to collect the data in a very meticulous way so that we can share that to the Medicare folks from a reimbursement perspective. We also plan to attack the commercial side of that equation as well. So in parallel to Medicare, we also plan to look at, at least one, if not a couple of the commercial payers to see if we can get some traction in those areas as well. And then while we're doing all of that, we will start to tackle maybe one other jurisdiction. But again, the plan is to try to stay as focused as possible. And I'm kind of holding the reins back until we do the proper review of the sort of the business case or the value proposition for pain management because if you recall, we sort of started down the path of labor and delivery and then pivoted over to pain management. And I want to make sure that we've got a clear message for the pain management clinics because it's a slightly different value proposition than it is for labor and delivery, where fluoroscopy is not used.

Okay. Great. And just to be clear, right, so the focus is on the jurisdictions in Texas, Florida and New Jersey, correct?

Correct. Novitas and First Coast are the 2 MACs that are supporting those 3 jurisdictions.

And just -- maybe it's too early to say, but just a little bit on the timing of -- you said you're going to collect that data and work with Medicare and make sure about reimbursement. But is that a 6- to 12-month process? Or what's at this point in terms of your vision of when broader commercialization will start? Do you have any clarity on that at this point?

Yes. I mean the broad adoption is challenging, but we plan on sort of restarting the program here in the next handful of weeks. We're doing a lot of due diligence behind the scenes with people who have a lot of experience in that world and we're gearing up to be ready to sort of reroll out CompuFlo -- the more data we collect early, the quicker we can get to a commercial -- larger commercial rollout. So again, we just need to be -- I don't have a problem of having people want to use it. The bigger problem is making sure that the people that do start using it get the proper information back to Medicare.

Our next question is coming from Bruce Jackson with The Benchmark Company.

I wanted to touch on the tariffs just real quick. Last quarter, you said that from a supply chain perspective, you're pretty well set. You have inventory in the states and for the international accounts, could ship out of China. Has there been any change to that during this quarter? And then secondly, with the international customers, are they -- have they changed their purchase behavior because of the current situation?

It's a good question. Thanks, Bruce. So as far as the tariffs, we're really not seeing much of an impact at all. We, as you mentioned, have the ability to ship out of China internationally, so to avoid that and plenty of supply here in North America to handle our business here. So we're not really seeing a whole lot of impact. As far as changing behavior, we'd like to see more customers initiating sale -- orders coming out of China. It's been a little bit lighter than we wanted it to be. So we're considering potentially having a bonded warehouse in the U.S. if the tariffs continue to persist so that we don't -- so that we can ship out of the U.S. and/or China. But we're not really seeing a tremendous impact from the tariffs.

Okay. Okay. Great. And then in terms of the United States marketing effort, any thoughts on the sales force or the composition of the sales force? Do you have, for example, reimbursement specialists on staff? Tell us a little bit about how you're structuring the sales force, thinking about the sales force right now.

Another good question. The -- as far as reimbursement, we really -- we've tried in the past for reimbursement on the Dental side unsuccessfully. We've talked a little bit about trying to get a pediatric code based on the use case there in pediatrics. So we go back and forth as far as looking to attack the reimbursement market on the Dental side because there's obviously a lot of cost in doing that, and it could be difficult. As far as the sales organization, we plan on continuing to ramp that up. We've got a handful of people doing it here locally. So we're anxious to add horsepower to the Dental team, and we've got a handful of programs that could expand our sales footprint pretty dramatically in the North American market. And I think there'll be more to be said about that in the coming weeks.

Okay. And then last question for me. With your sales, is there a seasonality pattern where the fourth quarter is generally a strong quarter for you? And as we're looking at the model, should we be thinking about an uptick in revenue for the fourth quarter?

That's funny you asked about. I used to be in the software business, and we always had the hockey stick in Q4. It was always -- we shoved all the business into Q4 and then it was a light Q1, a heavy Q2, a light Q3 and then a massive Q4. Here, it seems to be quite a bit different. It's very steady. I think we were $2.4 million, $2.2 million, $2.4 million. And we expect a similar quarter in Q4. So no real huge inflection in Q4. It's a pretty steady business, which is wonderful. But we'd love to see it tick up, and we expect a similar quarter as we've had in the past or no big, huge hockey stick.

Our next question is coming from John Corp, who is a private investor.

Nice to hear your presentation this morning. I am a long-term shareholder of Milestone Scientific, I would say, at least 15 years. Permit me, if you will, to give you the perspective of a long-term shareholder, and I might say a suffering shareholder because my hopes have been dashed repeatedly for the turn of events that might allow increasing revenues and positive cash flow and positive earnings for Milestone. I don't think you would have taken this job unless you believed as I do in the product. My dentist uses STA, has used it with me and it's a wonderful product. It was just terrific to get an injection like I received with the STA product. I try to attend every quarterly call. I started off by talking to Leonard Osser years ago, and he was enthused about your products as am I. But when Milestone received FDA approval and my hopes really got up, that was the beginning of a down slide that really took me by surprise. Since that time, the balance sheet has been ravaged. And I thought at one time, I really know where Milestone was going. And now I'm kind of at sea, I don't know where Milestone is going. I don't know what the challenges or pushback have been. You know, I don't know. I don't know how many pain clinics are using this. I don't know what their feedback is from the clinicians or the doctors. Could you help me with that perspective on where we are and where you -- what do you think the possibilities are for Milestone Scientific? And where those dramatic possibilities may be. The CompuFlo, obviously, but what is going on that we went from 10 salesmen to no salesmen to when your predecessor ended, we're inching along with trying to get 100 cases authorized for payment? It seems to me the cart may have been before the horse on this, but I don't know. Maybe you could help clarify what I don't know and give me some hope for the future of Milestone from your perspective.

Thanks, John. So welcome to the club, right? So I've been a shareholder since 2018, pretty significant investment in the company. And so I've been following it like you have, not quite so long as you have. So you've definitely got a lot more history than me. And I appreciate you continuing to support Milestone and for your patience and hopefully, for the future perseverance of the organization. But to answer your question, again, what I've observed in the few months that I've been here is, first and foremost, we have fantastic technology, right? So the STA, as you mentioned, the dynamic pressure sensing capabilities that also applied to the CompuFlo unit. Our technology is what it is, right? That hasn't changed. I think what has happened in the Milestone historically is that -- and I've seen this in other organizations that I've invested in is that it was probably a research-oriented company with a lot of inventions and a lot of patents and a lot of IP, but where it fell short, at least in the past from what I can see is it really didn't have true sales leadership that was driving the execution and the discipline required to scale and grow business in a proper way, right? And so when they rolled out CompuFlo and so forth, they had a little bit of a shotgun approach and got a lot of excitement going and a lot of use of the product, but they really didn't have a structure in place to maintain that business, and it's sort of all started to sort of fall apart, right? And so what we're doing is stepping back just a little bit, not a lot, and we're taking a much more focused approach with a very targeted group of customers and with support on the Medicare reimbursement front, so that we can do a proper rollout that can scale. And again, I think that's really it. The technology is great. The sales execution has been poor and the structure in place to support a scalable, sustainable business was just not put in place. And so your expression of the cart before the horse, I'm requiring that we build an ROI, a plan, a strategy before we jump into the market. And when you jump into the medical market, it is extremely sophisticated, it's extremely political. There's lots of moving parts. And if you're not prepared, you can get yourself into a tough unsustainable situation. So I'd just ask that you be patient. I know that you've been here 15 years, and again, we appreciate your support. But we're going to do this the right way this time.

Our next question is coming from Elliot Sparrow, who is an investor.

Eric, congratulations on a great quarter, best one in a long time. And I hope the trend continues. My question is along the same lines as what you've just been answering to Anthony Vendetti and now John. I'm curious why we had many, many successful trials and demos over the years with fantastic feedback from those people. How come they never translate into sales? And then b, again, as you've been trying to explain what is going to be different this time around?

Yes. I think one of the big changes, and it's sort of -- I guess, a little bit surprised if the question doesn't get asked, right? So we've got Dr. Demesmin, who is an early adopter, right? So he's been wonderful. He continues to use the product and he's surrounded by a lot of customers in New Jersey that are still using the product. But we've also added some high-caliber talented people, Shanth Thiyagalingam and now Dr. Sayed who have been advising us at least a little bit here over the course of the past handful of weeks. But we expect that with them on Board, helping us navigate this complex environment is going to be done in a much more focused way. And so again, not to hit on the old team who is trying their best and working very hard, but again, it's a very complicated process to go from a category 3 to category 1 and it's a very difficult process and requires a lot of data to be generated in order to get the proper reimbursement code number. So the doctors want to use your solution so that they can make money. So again, I think to sort of reiterate, we are stepping back. We're taking advice from many doctors, engaging that community and the engaging companies who have tremendous experience in that community to do it the right way so that we can start off very focused, get the data we need, get the reimbursement where we need it and then seek a larger commercial rollout over a handful of weeks or months. But that's really just it. It's -- sometimes the thought is you just go out there and start selling like crazy, and you hope that it will latch on. But what I'm finding out is in this world, it doesn't work. You have to have data, you have to have structure, you have to have all those things in place. And I think with the Board that we now have in place, we plan on leaning on them to help us navigate that complex infrastructure, namely Medicare.

Okay. Great. Fantastic. My second question is totally different, and that is just about how are we set for capital and cash? And I know we've saved $0.5 million this year, but how much longer are we good for? Or are we going to need capital? That's it for me.

Thanks, Elliot, for your second question. So the initial focus for me stepping into the company was to get control of the cost, right? And so we've done a decent job of that. We still have more opportunities to work on that. As far as the front end of the equation, I'm sort of turning the jets a little bit to the sales focus. So like I said, I've been holding back a very strong horse by the name of Jason Papes, who's sitting here with us. And the plan is to turn the sales jets on full steam ahead here very, very shortly. But the company is -- from a cash perspective, has got plenty of cash to keep going for several quarters. And so we always are looking at opportunities to improve that if we need to. But right now, the company is in good shape.

Thank you very much, Eric, and I hope we have more good news from you in the short term.

As we have no further questions in queue at this time, I'd like to turn it back over to management for any closing remarks.

No, I just appreciate folks joining the call. I appreciate the shareholders being part of this community and sticking with us. I share most of the sentiments that all of you do, part of the reason that I joined the company. And I can't say enough about how good I feel about having -- I hear from a lot of the different shareholders. And what I will leave you with is that everything I do every single day is about driving shareholder value. So for me, it's all about anything that I can do, and I tell everyone on the team, we need to turn into a sales-focused organization. So anything you do, whether it's product management, whether it's R&D, customer service and so forth, always be thinking about how that can benefit sales, how that can benefit our customers, and finally, how it can benefit our shareholders. So thank you very much, and thank you, David, for setting up the call. And we look forward to speaking with you all at the end of Q4. Good luck to all of us.

Thank you. Ladies and gentlemen, this does conclude today's call. You may disconnect your lines at this time, and we thank you for your participation.