Good day, ladies and gentlemen, and welcome to the Milestone Scientific Second Quarter 2021 Business Update Call [Operator Instructions]. At this time, it is my pleasure to turn the floor over to your host, Natalya Rudman. Ma'am, the floor is yours.

Thank you. Good morning, and thank you, everyone, for joining Milestone Scientific Second Quarter 2021 Financial Results Conference Call. On the call with us today are Arjan Haverhals, Chief Executive Officer; and Keisha Harcum from Controller of Milestone Scientific. The company issued a press release today on Monday, August 16th, containing second quarter 2021 financial results, which is also posted on the company's Web site. 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 second quarter ended June 30, 2021. 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 revenues and future success. These statements involve a number of risks and uncertainties and are based on assumptions involving judgments with respect to the future economic, competitive 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 risk factors that could actual results to differ materially from those indicated by the forward-looking statements are general economic conditions, failure to achieve effective revenue growth, changes in our operating expenses, adverse patent rulings, FDA or legal developments, competitive pressures, changes in customer market requirements and standards and the risk factors detailed from time to time in Milestone's periodic filings within the Securities and Exchange Commission including, without limitation, Milestone's report on Form 10-K for the year ended December 31, 2020 and Milestone's report on Form 10-Q for the second quarter ended June 30, 2021. The forward-looking statements made during this call are based upon management's reasonable belief as of today's date, August 16, 2021. Milestone undertakes no obligation to revise or update publicly any forward-looking statements for any reason. With that out of the way, we'll now turn the call over to Arjan Haverhals, Chief Executive Officer. Please go ahead, Arjan.

Thank you, Natalia, and thanks to everyone for joining us today. I'm pleased to report that our revenue for the second quarter of 2021 increased more than 14 fold to $2.4 million versus $168,000 for the same period last year. Our Dental business continues to generate strong cash flow as a result of dental offices reopening across the country and around the world. Moreover, we have enhanced our sales and marketing activities, which should support sales of our dental instruments and helped drive high-margin recurring handpiece sales. We believe our progress illustrates the positive response and growing market demand for our dental products. Through our new decentralized dental sales strategy, we are working towards our goal of building a robust distribution network in the United States and Canada. In parallel, we are focusing our efforts into new global markets while supporting our present distributors. Overall, we are encouraged by the growing interest in our dental technology. Our Dental business continues to generate positive cash flow on a stand-alone basis. And as we continue to grow this business, we expect to benefit from high recurring margins on our disposables. Turning now to our medical instruments. In the first half of 2021, we began selling CompuFlo Epidural and CathCheck disposables to four medical centers in the United States and one in Europe. We recently reported that the University of Texas Medical Branch Health, Clear Lake Campus Hospital, has initiated use of our CompuFlo Epidural Instrument, which follows the successful use of the instrument and disposables at the UTMB Galveston Campus Hospital. This expansion within the UTMB Health network is a validation of the favorable response to our technology by anesthesiologists. The purchase orders received from these medical centers reinforces our confidence in the outlook for both CathCheck and CompuFlo, and the value…

Thank you, Arjan. Total revenue for the three months ended June 30, 2021 was $2.4 million versus $168,000 for the same period last year. Dental revenues increased by approximately $2.2 million due to the reopening of digital office throughout the country and the rest of the world. Medical revenue for the three months ended June 30, 2021, and increased to $21,000 as compared to the three months ending June 30, 2020, which reflects initial purchase orders from our new customers. Revenue for the six months ended June 30, 2021 was $5.4 million versus $2.2 million for the six months ended June 30, 2020. Digital revenue increased approximately $3.4 million for the six months ended at June 30, 2021 as compared to the six months ending June 30, 2020. Medical revenue increased to $92,000 compared to the same period. Gross profit for the three months ending June 30, 2021 was $1.4 million or 56% of revenue versus $112,000 or 57% of revenue for the three months ending June 30, 2020. Gross profit for the six months of 2021 was $3.2 million or 61% of revenue versus $1.4 million or 71% of revenue for the six months ending 2020. The decrease in gross margin is due to an increase in sales to China, which have a lower cost gross margin. Operating losses for the three months ending June 30, 2020 was approximately $2.9 million versus approximately $3.2 million for the three months ending June 30, 2020. Operating losses for the six months of 2021 was approximately $3.9 million versus approximately $4.8 million for the same period last year. Net losses was approximately $2.7 million or $0.04 per share of the three months ending June 30, 2021 versus a net loss of $3.2 million or $0.06 per share for the comparable period in 2020. Net loss for the first six months of 2020 was $3.4 million or $0.05 per share versus net loss of $4.8 million or $0.09 per share for the comparative period in 2020. Now I would like to turn you into the liquidity and capital resources. At June 30, 2021, the company had cash and cash equivalents of approximately $16 million and working capital of $17.2 million versus working capital of $15.7 million on December 31, 2020. At this point, I'll turn the call back over to Arjan.

Thank you, Keisha. As Keisha mentioned, we continue to maintain a strong balance sheet with approximately $16 million of cash and cash equivalents as of June 30, 2021. We are very well funded and have no plans and no need to raise additional capital. In addition to hiring more salespeople and expanding our sales funnel, as I mentioned earlier, several trials are underway with leading hospitals. We are witnessing growing interest in our CompuFlo Epidural Instrument and CathCheck system among anesthesiologists and hospitals, and believe we are well positioned to take advantage of the growing momentum and adoption of our technologies as we pursue our goal to become the new standard of care for epidural procedures in labor and delivery. Although we face challenges during the pandamic, we are back on a strong growth trajectory, and I'm encouraged by the outlook for the balance of 2021 and beyond. We remain committed to driving shareholder value and look forward to providing further updates as developments unfold. I'd like to thank you for joining the call today. At this point, we would like to open the call up to questions. Operator?

[Operator Instructions] Our first question comes from Anthony Vendetti.

This is Anthony Vendetti from Maxim Group. You mentioned that [Chet] has 11 sales reps. I was wondering if you could talk about what their -- are they completely trained, do a couple of them still need to be trained? And once they're trained, has there been a sales quota set for them at this point? And then I have a couple of follow ups.

And I think you asked a couple of questions within this sentence. So let me go one step back. Has sales force been trained? Absolutely. At the beginning of the quarter, April, as you know, and as we commented on in previous calls, I would say we had a handful of sales representatives. And then in the second quarter, as there was more clarity about the pandemic in terms of the increase in vaccinations, we aggressively started by recruiting more sales representatives that all culminated in an in-depth, very fast-track onboarding program. And as of today, all the sales reps have been trained and are equipped with the right tools to be successful in the marketplace. So that's the continuous process, so to say, as we speak this week, there is a specific three day sales meeting for the sales rep to make sure that everybody is aligned for the goals that are set for the second half of this year. So yes, the sales reps have been properly trained. Yes, they also do get a target in terms of quotes. I will not go into detail how many quotes per sales rep. It also depends a little bit on the territory and the presence of the hospitals that are within the territory. But rest assured that, yes, the sales representatives, they do get quotes in terms of targets, in terms of hospitals that they have to have in their portfolio to be able to come up with new opportunities for the company. So the results of that and also, I would say also in combination with the experience that Chet brings, his coaching his salesmanship, his mentorship that is very encouraging for me, as I have seen an immediate effect in an increase in the number of demos and trials of numerous accounts that we are currently active in. Does that answer your question, Anthony?

Yes. And then just as a follow-up, you said you were in late-stage discussions with a number of hospitals, number is obviously a relative term. Is that a handful, four or five or is that 10% or more or is this -- I was just trying to get a better sense of that? And then just in terms of the -- there's late stage discussions and then there's a pipeline of what you would consider reasonable targets maybe you've reached out, you've had early stage discussions. How would you quantify those two categories?

At the same time, I'm afraid I cannot share in detail the number of hospitals because that will -- first, that will create some false expectations or expectations. This update call is an update call on the results for the second quarter. But again, I would like to reiterate and reassure you that the targets have been set. We have seen a number of hospitals where we actually went through the value assessment committee so that is short-term midterm opportunities for us. And then to your point, yes, the pipeline is, of course, completely focused and targeted on the period between now and the end of the year. Like I said in earlier calls as well, this year is so important for the company because we are in a turning point. We want to create that baseline with a number of hospitals during the course of this year, from which we then can build further on in 2022 in terms of recurring revenues of those initial hospitals. And in addition then, of course, continuing our hunting activities. At the same time, that could be another question and perhaps I'm preempting on that, for the time being, with the 11 sales representatives that we have in our organization, I do not have immediate plans to further expand on that sales organization because at the same time, I'm still focusing very much so on having our cost under control.

And then maybe it's hard to -- and each hospital is different. I know some are dealing with the surge in COVID cases. But if you looked at in a normalized environment, what is the sales cycle from first reach out to interest to closing? Is it a three to six month cycle, is it six months or more in general? And I know it varies but if you can give a range on an average…

Yes, I think my reply would be to your question would be the following. It completely depends on the type and the magnitude of the hospital. Let's say, for example, if we would go to Harvard in Boston, that's definitely going to be a longer cycle than the hospitals that we already have been engaged with. So what we are doing is providing the right mix from a strategic importance level to have the right hospitals, but also the smaller hospitals. There are also hospitals that do not necessarily have to go to through a value assessment committee. What we also are doing is going into ASCs or private clinics because there we do not necessarily need any value assessment committee approval or whatsoever. So at the same time, in this stage, in this transition, like I said, we are trying to change the company from an R&D focused organization to a more sales driven organization, we are also looking into other areas for private practices where our technology definitely can be used today.

And then just the last question on publications. I know there's been a drive to publish the results, which from the early studies have indicated, obviously, a huge decrease in complications, particularly for epidural punctures using CompuFlo versus the traditional, shall we say, needle stick. Do you have any expectation of any other publications showing the safety and efficacy and superiority of the CompuFlo system?

There will be publications, like I said, coming our way, in particular from a group in Italy. That is also further confirmation and validation of what we already have seen and reported. Like we said in previous calls, we also have publications in the area of peripheral nerve block, which is a potential new area for us as well. Globally, there are about 41 million procedures. But of course, we need to make some developments on the product as well. And also what we are working on is the indication for thoracic indications of injection of the drug. As you know, it has been approved in Europe and it's also important that we get approval for that indication in the United States because even in the thoracic indication where the space is smaller and narrower, the immediate need for an injection technology like ours is evident.

Our next question comes from James Terwilliger.

Very quickly, you said previously 11 sales reps on the medical side. Are all of those in the United States?

That's correct, yes. So the way it is constructed. So within the 11 medical representatives, one Vice President of Sales, one Senior Director of Sales and then nine territory managers whereas then those 10 people that I just mentioned all have their individual quotas, sales quotas in the United States. The next question could be where are they situated in the United States. So I can share that with you. We have covered the Greater Chicago area, Boston, Connecticut, New York, Texas, California and North Florida, South Florida, Maryland and North Carolina, South Carolina, I think that if I count quickly, that should be the correct number. So those territories have been initially selected by us as they represent those states where the majority of important hospitals are or even larger IDNs. And of course, we also take the benefit still what we are continuously doing, taking the benefit of the GPO agreement that we have with the Premier group. So that's important for our targeting as well. And then on the international platform, our sales strategy is more through distributors, although, we do have a dedicated salesperson but that is on a contract basis, because we do not have a legal entity yet in Europe where we can have people on our payroll. So that's on a subcontracting basis. But that person also has experience within the medical device industry and his responsibility is to assist and help us further in all the business development and sales developments in Europe, Middle East and Africa.

My next question is, as we spoke about the medical. Can you remind me how your distribution strategy is on the dental side?

So I go one step back at the beginning of the year. We announced that we moved away from our dependency of Henry Schein as our exclusive distributor and we changed that into a multi distribution channel strategy. And the main reason is the following. If you look back and I always look back to the revenues of 2019, if you look back to the revenues in 2019, which were about $8.4 million in total revenue for the Dental business, $7 million of that $8.4 million has come from consumables alone. So if we want to grow the business exponentially in the Dental segment, we need to have additional placements of units, what I always call new customer acquisition, right? Because that's the only way that we can grow the dental business instead of taking the benefit of the recurrent revenue stream only. So that decided us to make a move. So we changed the exclusive distribution agreement with Henry Schein into a nonexclusive one. And then at the same time, we were able to appoint seven distributors in the United States and one in Canada and for the reason of growing the business. But we also go one step further, because, as you know, probably from managing distributors, they always need help and they need strong help from an organization like ours as well. Personally, I handle the distributors as an extension of my sales force. So that means that we, as a company, have a responsibility to provide them with the right marketing tools, the sales tools, the right strategic initiatives for them to be successful as well as providing services in terms of field sell strips or co visits for their representatives. And we have a very well experienced salesperson in our organization in the United States,…

I've got two very quick questions. One, when I look at the balance sheet and the inventories, the inventory levels dropped a little bit. Are you having any supply issues? I know a lot of companies are having issues with their supply chain. Are you having any supply issues as it relates to inventories?

No, we do not have any supply issues to that extent that it is dangerous for our business at all. There are two issues, of course, based on raw materials, which are normally the sensors and the chips, but we have catered for that. The only reason why you see a drop in the inventory is primarily related to the difficulties of getting the containers that are shipping the goods between China and the US. There is a shortage of that. There's no manufacturing issue or whatsoever. So as we speak, we already have taken measures to increase further the buildup of our inventory.

And then the last one, in the previous remarks, I'll jump back in queue. Did they say -- did I get this correct, the medical business was approximately $21,000 in the quarter and $92,000 for the first half of '21, are those numbers the correct number?

Yes, we said that the medical revenue in the first quarter increased to $21,000 compared to the same period last year. And for the first six months of the year, the medical revenue increased to $92,000 compared to the same period last year.

[Operator Instructions] Our next question comes from [Les Quenes].

I'd like to know when you expect to see milestones become profitable on a sustainable basis?

Everything depends, of course, on the uptake of the medical business as we have said many, many times. As we are looking at the current business in both Dental and Medical, I do not believe that cash positive will be possible this year. But we are doing our utmost to turn this into cash positive operations in the year 2022.

[Operator Instructions] Our next question comes from [Michael Mortensen].

I'm trying to call it up because, obviously, the technology is, I believe, fantastic. Yet if you just view things based on what's been going on, the first quarter of 2020 seems to be flat or down from an average quarter in 2019 with, of course, no COVID around in the first quarter of last year. And then this year, although, of course, the number is quite, so to say, eccentric 14 times, I mean the reality is that you grew revenues by about 33%. And I'm just wondering, I mean, I don't know how big or what the sales force was like in '19, but if we've increased it and improved it so much, shouldn't we be seeing a much larger number of growth? But more importantly, I mean, when are we going to see $25 million, $50 million? I mean, this is a great product and it seems like it's only going out to a few hospitals. And I'm just wondering, is it an insurance thing? I mean what seems to be the problem. This type of growth, I don't know if we'll ever get profitable would that be in the case.

So let me comment on that. If you look at the revenues in 2019, 2020 and 2021, the revenues reported in '19, and '20 and '21, major revenues have contributions from the dental business, and that's independent of having a direct sales force or not having a direct sales force, because the direct sales force is primarily responsible for the medical business. Now the first quarter this year, unfortunately, and I've mentioned that on previous calls as well, unfortunately, we had a little setback. Firstly, because of the sudden passing of our Vice President of Sales, Eric Gilbert, and also the departure of another salesperson. So at the end of the quarter, we had two salespeople. Then at this time, it didn't make any sense for the company to invest money, incur the sales force expansion because the situation with COVID was unclear. Why should we invest in building up a sales force in the first quarter, knowing that they are knocking on doors that are closed, i. e., the pandemic? When we saw in the second quarter a change in that economic environment that we all have faced business wise, private wise, personal wise. That's what we decided then in the midst of the quarter to accelerate the recruitment and the expansion of the sales force. We should not forget that we started the commercial activities with the sales team in the beginning of 2020 and then COVID came. Hospitals closed the doors, hospitals did not invite representatives of their vendors at the hospitals. Capital equipment budgets were frozen and that slightly changed in Q3, Q4 last year that made us possible with those three people to have a number of hospitals at the end of last year and beginning of this year, to actually provide purchase order for this technology. Then you're right. We had a setback in Q1, as I explained to you, then we reacted in further investing aggressively in our sales team and that's where we are now. And like I said, I am very encouraged about the increase in demos and trials that I see. And I'm also encouraged and positive with the outlook. Now the question that you have, when are we going to be -- when do we see the revenues of EUR25 million to EUR50 million? That's a very good question, because that's the question that I raised myself and ask myself every day, and that should be embedded in the right strategy for the company to reach those numbers in the coming years.

Well, at $92,000 in medical right now with an increased sales force, it could take forever. I don't know if I'll be alive. And again, it just is shocking, because, I mean, this company should be growing in leaps and balance. And I'm wondering why McKesson or someone of that nature hasn't either looked into distributing or even considered buying it themselves because of the technology. Yet, I don't even see a site yet potentially for [tentative] and we've got additional shares out right now. I think there's a number of what, let's call it, $49 million, $50 million that certainly, of course, may have increased because at this rate with continued hiring and expansion of the force that's only growing in baby steps, it's just hard to believe for my clients to continue to hold that we're going to see. I mean even in the market, it was 1.94 this morning, it's now 1.67. Obviously, people are questioning it and deciphering what I see, which is it should be way, way further than where it's at. But hey, that's my opinion and I certainly am not in your shoes. But if you've got this great sales force, I mean, let me ask you this. Are they selling both of the products and trained to do so or are these guys just doing the medical that really hasn't went anywhere.

So again, let me -- perhaps that wasn't clear in my statement. We only have a direct sales force for the medical business. So only 40 CompuFlo Epidural, CathCheck and CompuWave. And the reason for that is it's a pretty intensive sales process because you have to do the demos and the trials. Now with all due respect, I don't think the 92,000 can be directly linked to having a sales force being successful or not successful as these people come on and came on in the middle of June. The 92,000 in the first six months, 88% is coming from, I think, the international business. So that has nothing to do yet with the expansion of the sales force. I repeat again that where we are today, we are building that, creating that baseline to benefit and to have this from all these activities that we have undertaken since the end of June and throughout the month of July to have more hospitals adopting and buying our technology during the course of this year. So I think that's what I would like to reiterate. And again, I remain positive. I can understand that perhaps you think it takes longer time than you anticipate. But I always say, again, nothing has changed with the company. We are in a very strong financial position. I believe that we are taking the right decisions of where to make the investments. And let me take one concern away. Are we only focusing on the direct sales force? Absolutely not. As we speak, we also have discussions, in particular, in those areas where we currently are not present, we have already initiatives with more local or regionalized distributors that will assist, support and help us in the sales of the epidural instruments and the epidural consumables and the CathCheck consumables.

Well, Obviously, I'm a salesman for 36 years, and I could tell you that if I was only dealing those type of increases, I wouldn't survive. And I'm only myself. So maybe I expect a lot more of people and myself, but I just am hoping that the second half of this year is more like something in the neighborhood of $5 million to $10 million, because that's really where it should be and certainly look like where it was starting in '19, although, I wasn't aware of the company at that time and I only started participating and we did the offering at $2 or so back in October. But I do believe in the technology, and I hope to see as certainly with D'Agostino at the helm, certainly the burn rate was very low and I thrown a lot of it. And that's something that I'm certainly going to keep an eye on going forward, because we certainly need to get to profitability, but it's the leaps and bounds of the product, especially when two of the products are probably the gold and some rule in the industry, you start to wonder, I mean, it does have to do with insurance? I mean, are people that aesthetic that they're stepping over hundreds to pick up 20s. It just doesn't make sense. Because although I haven't used the product and I went out and endeavored to try it, but I didn't find the right dentist, certainly, of course, I believe in it. And if it's the way it is, I really think it should be moving a lot faster. And it just doesn't seem to be catching the momentum that I believe the product deserves. So on that note, look, I miss to have a house. It's certainly never an easy task, especially when you got what you're up against, but this, you've got a great product. If you've got a go with some more product, it really -- it should be multiplying in much bigger ways. And again, now we're back into something different with the cover again, so I don't know how bad or good that will be but in the hospitals, babies are still being born and epidurals are still needed. And I mean if it is what it was said to be and I believe that it is, I certainly think that that business should be doing a lot better than what we're seeing, although, it's kind of new that should be a multimillion dollar business for the second year. But then again, it may be there, I don't know I'm hoping…

No, I can agree with your outlook and your expectations I think the only -- yes, I would say where we perhaps have not the same opinion is the time that we can achieve those numbers. And also your comment on the dental business that you expect a faster uptake or a faster development. If I look back at the first half 2019, I know that we in this -- are not directly reporting and comparing the results of this year versus previous years, but I do that for my own sake, that was a year prior to the pandemic than in the first half year, we have achieved a growth rate of 27%. Now is that good, is that bad? I'd rather be happy to see that the initiatives that we are undertaking that they saw at [ESAC]. And of course, to your point, it can always be better. But we are working hard on that to get the numbers that we would like to have.

Well, I wish you a lot of luck with that, and I hope that we get there. Again, I believe in the product and the technology, and I think it's something that's just not -- I don't know. In my opinion, I'm just thinking explosiveness when I first viewed it and I'm not catching that. But of course, again, it's such a waiting right now that's unprecedented and not an easy thing to be up again. So I do wish you well and I hope for the best, and let's get to $25 million this year and sure we won't be looking at a $2 stock or $1.70 stock.

Well, thank you for your questions. And perhaps there might also the other people underlying it want to have some questions.

And it looks like that was our final question. I'll turn it back over to Arjan for closing remarks.

Yes. Well, thank you for your time and the interest in our company and your support also for our company. As you see, we believe in our technology, we believe in having and doing the right initiatives in terms of marketing and sales, also investing in other areas where our technology can be employed in the medical industry. And we remain very positive and are encouraged to follow up with you in future calls. So thank you again, and stay safe. All the best.

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