Greetings. Welcome to the Milestone Scientific 2022 Year-end Financial Results and Business Update Conference Call. At this time, all participants have been placed on a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] Please note this conference is being recorded. I will now turn the conference over to your host, David Waldman, Investor Relations. You may begin.

Thank you, Holly. Good morning and thank you for joining Milestone Scientific's 2022 year-end financial results conference call. On the call with us today are Arjan Haverhals, Chief Executive Officer; and Peter Milligan, Chief Financial Officer of Milestone Scientific. The Company issued a press release today, March 31, containing 2022 year-end 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, (212) 671-1020. The Company's management will now provide prepared remarks reviewing the financial and operational results for the year ended December 31, 2022. Before we get started, we would like to remind everyone that during this conference call, we may make forward-looking statements regarding the timing and financial impact of Milestone's ability to implement its business plan, expected revenues 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 the 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, 2022. The forward-looking statements made during this call are based upon management's reasonable belief as of today's date, March 31, 2023. Milestone undertakes no obligation to revise or publicly update any forward-looking statements for any reason. With that, we'll now turn the call over to Arjan Haverhals, Chief Executive Officer. Please go ahead, Arjan.

Thank you, David, and thanks to everyone for joining us today. 2022 was an eventful year for the Company as we achieved a number of milestones related to the rollout of the CompuFlo Epidural System. Most importantly, we were successful in seeding the market across a number of key hospitals, health care systems and pain management clinics as well as key opinion leaders in the field of anesthesiology and pain management. The fact that our technology was adopted by these leading physicians and hospital systems reinforces our confidence in the market potential for our instrument, particularly within the labor and delivery and pain management markets, where we focused our initial efforts in 2022. More recently, we received 510(k) FDA clearance for use of the CompuFlo Epidural System in the thoracic region of the spine, including the cervical-thoracic junction, where the incident rates of morbidity are believed to be much higher than in the lumber spine region at 17% and 30%, respectively, due to the difficulties accessing the epidural space. These widely acknowledged risk factors have helped drive adoption of our CompuFlo Epidural system within a number of prominent pain management clinics. The importance of the pain management market cannot be understated. The pain management market is believed to be at least twice the size of the labor and delivery market segment. And not only includes numerous hospitals, but also specialty centers, outpatient centers and sports medicine centers. Furthermore, we have experienced that the decision making time or sales cycle is much shorter in these private pain clinics compared to the labor and delivery department at hospitals. In other words, the recent FDA 510(k) approval increased our accessibility to the total addressable market for epidural analgesia. Within just 2 weeks of receiving the thoracic clearance, we announced that we commenced sales…

Thank you, Arjan. Total revenue for the year ended December 31, 2022, was $8.8 million versus $10.3 million for the same period last year. Dental revenue decreased by $1.4 million due to lower revenue from China of $1.4 million and a decrease in domestic revenue of $278,000, of which $179,000 related to an allowance for sales returns due to the termination of the U.S. distributor agreement. Medical revenue for the 12 months ended December 31, 2022, was approximately $53,000 versus $152,000 for the prior year, which was primarily the result of changes to the Company's near-term commercial strategy. Gross profit for the year was $4.9 million or 56% of revenue versus $6.3 million or 61% for the prior year. The year-over-year decline in gross profit was driven by lower revenue and the impact of an approximate $400,000 noncash inventory reserve related to medical products. Operating loss for the year was approximately $8.8 million versus $7.4 million for the prior year and then a loss to common shareholders was $8.7 million or $0.12 a share versus a $6.8 million or $0.10 a share for the comparable period in '21. Now I'd like to turn your attention to liquidity and capital resources. We continue to carefully manage expenses and have maintained a solid balance sheet. Company had approximately $8.7 million at the end of 2022. Current assets were $13.7 million and working capital was nearly $10 million. At this point, I'd like to turn the call back over to Arjan.

Thank you, Peter. As Peter mentioned, we continue to maintain a strong balance sheet with approximately $8.7 million of cash and cash equivalents as of December 31, 2022, which provides us substantial resources and the ability to accelerate our sales and marketing activities around both our dental and medical instruments. Through our new sales strategy and our enhanced marketing efforts around the STA single-tooth anesthesia instrument, we believe this will increase our market penetration as we focus on the significant value drivers of our instruments including safety, efficiency and importantly, supporting the growth of dental practices. We believe we have developed an efficient and scalable platform to help drive our dental instruments and hand pieces sales in the coming years. In addition, we remain confident in the market potential of the CompuFlo Epidural System, which we believe will transform the industry and ultimately become the standard of care. In summary, we are gaining momentum, building upon the early success of our initiatives. And given the recent developments, including the addition of new hospitals and pain management clinics, expanded distribution and our streamlined operating structure, we believe the future is bright. We are excited about the recent 510(k) FDA clearance for use of the CompuFlo Epidural system in the thoracic region of the spine, including the cervical-thoracic junction. And finally, we look forward to continuing our efforts regarding the implantation of the CPT code, which will support planned initiatives on the reimbursement front. We also look forward to advancing a number of key initiatives following SAM approval and leading up to potential federal supply system approval, which would open up the sizable government market. We remain committed to drive shareholder value and look forward to providing further updates as developments unfold. I'd like to thank you for joining the call today. And at this point, we would like to open the call up to questions. Operator?

[Operator Instructions] Your first question for today is coming from Anthony Vendetti at Maxim Group.

Arjan, I was wondering if you could talk a little bit about the transition away from your previous dental product distributor towards an online platform. If you could just -- I know that impacted sales in the fourth quarter. Can you talk about the uptake that you're seeing or the traffic numbers that you're seeing in terms of your on-site sale? And do you feel like that transition is complete? All the customers are aware of it? Or do you think it will continue to play out over the next couple of quarters?

Anthony, thank you for your question. I would be delighted to shine some more light on the situation. As we reported, historically, we all know that the agreement with our prior distributor automatically ended by the end of last year. And then the Company, of course, has several opportunities, as we all know, we have a pool of smaller distributors or you do a hybrid or you decide to go direct. And we took the decision to go direct for the very simple reason. And the simple reason being that the in-market price, so let's say, if we sell our products at a transfer price to a distributor compared to the in-market price, the price would almost double thereby also our margins would significantly increase to different levels than historically within the Company. Now, was there a risk in that operation? Absolutely. But I made the decision or we made the decision that there was no other opportunity. And in particular, for the midterm and the long term, there was so much upside potential that we decided to launch the portal. So that activity already and that preparation took place during the mid of the third quarter last year, fourth quarter last year to be prepared for the official launch of the portal in the beginning of this year. Now, the challenge, as you say is, of course, how do you reach out to the entire dentistry population in the United States. I don't know if everybody has seen that. But I would say, we did not overload the market, but we made sure that the dental population was targeted and received as a minimum the information that we went with our portal and that they could order the products online over our portal. And that brings me to the second question or the second part of your question, how the pickup has been and how the take-up has been. Again, without going into detail, I can assure you that I am pleased with the development of the portal in the first quarter. And to shine a little bit more light on that, not only am I pleased but I'm also convinced this has been the right decision for the Company moving forward, which I believe that in part of -- or despite of the, let's say, the lower results in the fourth quarter, that we will gain and enjoy increasing revenues and higher margins in the next coming quarters. I'm very pleased with the development that we have seen as a direct result of the portal. And also, I would say, of the number of customers that we have been able to serve. And in addition, there's a lot of marketing -- market intelligence coming our way of which we can benefit from. And also drive upselling through our portal and the people internally that provide excellent customer service and support, thereby growing the business further. Does that answer your question, Anthony?

Yes, Arjan. And then -- maybe as we shift to the medical side, you've had a couple of recent events, including the 510(k) clearance for the CompuFlo Epidural System in the thoracic region, including the cervical-thoracic junction, which obviously, there's -- one of the areas where there's increased rates of morbidity, and we all know the lumbar spine is a big area. Can you talk about the opportunity now because you've mentioned that it's much easier to get into the pain management clinics much shorter sales cycle. Where you -- how you see that opportunity playing out over 2023? Because now you also have a Category 3 CPT code. Do you feel like your 2023 is well set up now to really develop the medical side of the business?

Yes. Thanks for the question, Anthony. Personally, I believe, without sounding arrogant or bullish, but I do believe that the Company has now better tools in the toolbox, so to say, compared to 1, 2 years ago. And the main reason is the following. Of course, for good reasons, the Company entered the labor and delivery market segment. We all know that the decision-making process within the L&D department is much longer. It's 6 to 9 months without, let's say, the larger hospitals where it can even be longer. And remind ourselves that 1 year ago, we made an attempt to go in the price of pain clinics. I personally visited a number of that. And I challenged the organization to reapply or resubmit for a CPT code. And in addition to that, we made the decision to submit an FDA file to -- the 510(k) file to the FDA for the cervical-thoracic indication. Now beautifully, all these elements came together by the end of last year and the beginning of this year. And let me explain what I mean by that. First of all, we had success with price at pain clinics. Some of them decided to use our technology because of allergic reactions to fluoroscopy and contrast media dye. Some of them used our technology in complicated cases for spinal cord stimulators. But we all knew that being successful or having an opportunity to be successful within the private pain clinics, you need to have access to a reimbursement code, right? Now what I've always have said is the reimbursement code is a journey. We have a temporary code. We work with professionals that have a lot of know-how within that whole reimbursement environment. And as a result of the 510(k) approval, we also were able to get…

Okay. No, that's great. I think -- just because of -- one last follow-up, because I spoke to a KOL on the pain center, who was very knowledgeable and said -- he said he's going to be recommending this to his colleagues because it's pain free. You get an exact location where -- so is there -- I'm sure there is a plan, but maybe just elaborate on the plan to get more KOLs because we all know that health care is local. More KOLs on board on the pain management side? Or is there either simultaneously a plan to get into or penetrate more of the university hospitals where you can get further validation that your CompuFlo system is sort of a must-have versus the traditional way of injecting patients?

Absolutely. And that's absolutely the case. So definitely, I know what's going on, of course, but I'm a type of person that I only announce news when it is valid, whether this is confirmed and when there is a signature in place. But I can share with you that as we speak, we are adding clinics to the existing 2 clinics that we announced. And also automatically, these clinics will, of course, also work on the -- not only the thoracic and the cervical indication as well as lumbar, and we'll send in the documentation to the health care insurance providers being public or privately owned. That's one side. On the university side, again, our potential and our opportunities have increased because we are not only dependent on labor and delivery. With the thoracic cervical indication, we can go like we did in the University of Illinois -- not Illinois, sorry, the University of Louisville, Kentucky, where at that time, they only decided to use it for the lumbar region in the OR, the pain and the labor and delivery. Now they have the other indication. But more importantly, we add the number of physicians that could benefit from the technology that we are providing, like neurosurgeons, surgeons in general, internal medicine. Because what I meant by that we have increased the accessibility to the total addressable market instead of only addressing 2.4 million epidural procedures doing labor and delivery as part of the total of 11 million procedures in the U.S. only as the total market, now we are in that position that we can address that entire market. Like the cervical-thoracic junction is about what we always say, is twice than the lumbar pain market, that's a large market. But now we are playing, and we have the potential to play in different segments of that market. And we all know that we are underpenetrated in that market. But with the tools we are having, now we have to execute and find additional partners that can help us in increasing the penetration and adoption of the technology in the medical segment.

[Operator Instructions] Your next question for today is coming from John Korb, a private investor.

Anthony answered, you answered a lot of the questions that I had through answering these questions. I was struck by that day you announced that thoracic approval of the participation in the market. Milestone traded almost 2 million shares that day out of the blue. I was stunned by that. Maybe you were too that just told me that a lot of people, a lot of market observers and investors who are waiting for this approval. I didn't even know that approval was untapped. Are you waiting for other types of approval from the FDA? Or is this set?

No. Well, if we wait for other approvals for the FDA, then it would be in total different areas. I think focusing on the current portfolio and the current technology, I think we are very well positioned and covered in the, I call it, the spinal region because we cover the entire spinal cord region. But more importantly, we cover all indications, procedures, diseases, therapies, et cetera, that are in the spinal region. So we can play a role in spinal cord stimulators. We're looking into a combination of radio frequency, spinal stimulation, spinal infusion, et cetera. Now to your point, I can give you an example, and that is, of course, a market that we continuously analyze it, for example, the market of peripheral nerve block, right, which is the peripheral anesthesia for larger procedures where we have been granted a patent, not only in Europe but in the United States as well. And that would be a potential next research and development area, and that would allow for a potential new submission to the FDA. But I don't want to dream here. We have not initiated any steps in that direction. With the size of the Company and the organization, we have enough on our plate to work on day in, day out. I always say as a joke. Unfortunately, the day has only 36 hours. So we are trying to do whatever we can do to make things work. And I think you will be appreciative of the explanation to -- or my questions -- my answers to the questions that Anthony raised is, there's a lot of activities going on in the background, like a simple thing like a thoracic approval or a CPT approval. It requires tremendous work of my team and I need to keep them motivated. We need to create that good environment. There's a very positive light in the Company based on the initial results of a simple thing on the portal. And that will help creating a high-performance team and a high-performance culture that we need to bring the Company forward. So I'm going a little bit sidetrack, but I hope I have answered your question in the professional way.

That feedback is very helpful because I wonder sometimes what is going on, I can only presume especially after that one day of trading after that approval was granted. The things are going on that I don't know about as a shareholder.

No, absolutely, John. It's a very good question. I just have one other comment to make just -- because you said that you appreciate -- you're appreciative of the activities that are ongoing. So -- also what we are currently doing from, in particular, in the dental market space, we have recently addressed much more the patients, right, because we always go to the dental professionals. And I've shouted at several months from the rooftop that I wanted to see a direct patient marketing approach. We have initiated that. And it's very nice to see that in the last 2 weeks of the instruments that we sold ourselves direct, that our team has very -- yes, executed very well from a professional point of view that the reason why a number of these instruments and new accounts were coming our way was because the patients were asking the dentist whether they had that technology available. So that's another activity that we are accelerating on tremendously because I've always said that -- at the end of the day, if you or I go to the dentist, and we would say, do you have that technology because I don't want to have any pain. And the dentist said no. And you would say, I will go to another dentist that your dentists would not be very happy because there's no dentist in the world that likes to lose patients. So it's just another flavor of the activities that are ongoing in our company.

Okay. Well, I have been a recipient of the STA technology off my dentist, and it's wonderful. That gave me encouragement. At one point, we talked about this before. You had started out with 10 salesman for the hospitals and universities. And then you're down to 5. Do you still have 5 salesman, or has that changed, too?

No. We have 3 full-time equivalents, and that's also the reason why we have signed up in the middle of last year with CTI, Clinical Technologies Incorporated that have a footprint in 22 states in the United States. And for the time being, we are looking at more partners because we all know and we all are appreciative that the direct sales team is putting sufficient pressure on our balance sheet, so to say, from a direct cost point of view. Now of course, you can say going with a distributor, it will hurt your margins, absolutely. But that is controllable through pricing or through other activities. But it didn't make sense for us and for management of the Company to continue to maintain a direct sales organization of 10, 11 people. And I have to be fair without significant success at that time. And I'd rather focus on creating shareholder value and keeping the financials of the Company in a good place and a good spirit.

Okay. I'm going to -- and was asking your question, you may not be able to or want to answer. What can we look forward to this year? At one point, we talked about the snowballing effect or they're going to get a critical mass, either in pain management or epidural or wherever, and there's going to be a snowball effect. Is that still possible scenario you're looking at? Or is it going to be more of a slow, steady rollout? And when might we really gain the traction sales and earnings wise, so it's noticeable to shareholders and to investors more than it is now? I mean I know from that 1 day of all of a sudden 2 million shares traded, there's a lot of people paying attention to the Milestone Scientific. So what -- are you more encouraged than ever for this year? Or are we just very tentative still? Or what's your current thinking that you can comment as fairly and as best you can?

Yes. No. So I'm definitely positive, and I'm definitely encouraged. The snowball effect that's always potentially possible, and it's triggered through different things. It's not only on the thoracic FDA approval, but a snowball effect would be when we hear back from the first health care insurance providers that would accept and would set the pricing on the reimbursement that will be one thing. Another snowball -- potential snowball effect would come if we would be successful in the governmental business. Another snowball effect would come if we would be successful in a neurosurgery department at a major hospital that would use our technology for a spinal cord stimulator. So it's a lot of things there. Now, I'm respectful that you are aiming at the medical business as such. But of course, as management, we look at the overall company. And the goal for our Dental business is growing that business significantly, exponentially. The goal for the medical business is to get a foothold and a footprint in the marketplace. Whatever that number will be, we are not going to allude on that. And of course, for the Company overall, we are looking at operations and the financial well-being of the Company to secure that at a certain moment whenever that will be in time, that at least we would get a quarter that we would be cash neutral. That's the goal of the management. Without going into the details about the timing and when that's going to be because I cannot look into a crystal ball. Like I said, the only thing that we can do is execute, execute and execute and following the strategy that we have identified and decided. And always make sure that for the investors and for the shareholders that they get a consistent message from us from management, which is based on facts and which is based on the real picture.

Your next question for today is coming from Mike Pfeffer at Oppenheimer.

What are your -- can you talk a little bit about your expectations for cash burn going forward? How do you think about it? Whatever you can share with us?

Yes. So the expectation on the cash burn this year, the goal is that should be at lower levels that we had in prior year, from a general point of view. I will not go into detail what the cash burn will be year -- quarter-by-quarter. But I would say also what you -- what we should not forget is the following: By having the portal, it will definitely also help us in our cash management, right? Because the majority of the transactions that are being done over the portal is by credit card at higher prices than what we normally would distribute that to the prior distributor. So from a cash situation and a cash balance point of view, we would be in a better position than in prior year. But I'm not in a position to share with you what the burn would be quarter-by-quarter for the coming year.

Okay. And then obviously, the CPT code could be very important for you guys. And you talked about -- I think you said you're sort of at the point where the doctors are waiting for feedback for the insurance companies, whether they can accept or deny these claims. Can you talk anything more about that, about the process or the timing to hear that? What can you make us smarter about that?

No, absolutely. No, just to be 100% sure. What I said was that doctors, the 2 clinics that we have been working with and as we have announced and we are adding more clinics, that these doctors have sent in the information to the healthcare insurance providers. And then it's a period where the healthcare insurance providers have to provide the feedback to the clinicians, right? That can be 30 days, can be a week, it can be 6 weeks, out of our control dependent on the health care insurance providers. And then what normally happens is you get an immediate acceptance or you get a denial. Now the denial can be based on procedural mistakes. I think I mentioned that to you on one of the other calls, Michael, that -- it can be a very simple thing from using a staple instead of a paper clip. Or it is a clinical argumentation or a procedural or filling out the forms, right? That depends. And I don't know yet because I have not received any feedback yet. What the quality and what the type of feedback of questions have been from these health care insurance providers. Now, without promising anything, I'm just sharing what my expectation is. So this is just me shining my lights on that. I do hope and my ambition is you know that within the quarter, at least, we get some initial feedback from these health care insurance providers. That's all I can say, right? And otherwise, it's going to be guessing, and I don't want to create any false hopes or provide any false expectations or whatsoever. The only thing that I can say is we're doing whatever we can do to professionally execute on this process. And the goal is to have additional clinics sending in more claims to the health care insurance providers because when we increase the volume and the health care insurance providers see that more clinicians are sending in the coding and the bidding papers, it will potentially also first enhance the speed of feedback; b, create an increased awareness of the health care insurance providers; and c, hopefully, facilitate a decision-making process at these health care insurance providers. That's all I can share, Michael, because I would not know more about that than you would potentially find out with other people that are active within the medical health care.

But I guess the takeaway, though, I heard from you is that you -- I can expect from your comments or we can expect from your comments that other clinics will be putting in more claims as well beyond these 2 that there's other things in motion that there'll be a greater volume going -- occurring going forward at some point. Is that reasonable to say?

That's absolutely correct.

Okay. And then the last question, the SAM approval, like, what's the potential timing? Like how long could that take? Can you give us any color on that?

Yes. So the SAM approval, so we are approved for SAM, and SAM is one step in the entire process to be approved as a vendor or supplier or having access to the government business. So I always explain it in the following way. The SAM gives a license to hunt, but you still need the federal supply schedule. You need to be at the federal supply schedule and why is that important? Because that would mean that all the VA and the special operations of the Department of Defense, that would mean that you are approved, but more importantly, also the price is set. And so you would not have any -- if a VA sees that we are on the FSS so that our technology on the FSS, there is no discussion about the pricing, and there's no discussion about being approved as a technology for the DoD. Of course, you still need to work with partners that have access to the VA and you still have to present the product and demo the product and evaluate the product, et cetera, et cetera. But there, I believe that we are in a good spot to have access to these VAs. But still, there's work to be done.

So then just on the federal supply schedule, can you give us any color on the timing of that? How long did that take?

Yes. Again, it is the same thing that the discussion that I had with you and other people about the FDA. The FDA normally has a timing schedule. Let me put it in this way. Without promising, I expect that in the near future and potentially, I believe that, that would come perhaps somewhere within the second quarter.

Okay. That sounds very promising.

But again, you ask me the question what I believe. I'm not making a promise and I'm not saying that, that will be the case.

We have reached the end of the question-and-answer session, and I will now turn the call over to management for closing remarks.

Yes. Thank you all for your time. I do believe that you would be in agreement with me and with management that -- the Company is in a good position, and we are executing on the strategies that we have identified. I really thank you for your time. I am appreciative of the quality of the questions that were raised. In case you have any further questions and you want to contact management outside of the normal earnings call, we are approachable. And I wish you a Good Friday and a good weekend, and please do stay safe and to be continued and looking forward to our conversations in the future. Have a great day. Thank you so much.

This concludes today's conference, and you may disconnect your lines at this time. Thank you for your participation.