Milestone Scientific, Inc.

Good morning, ladies and gentlemen, and welcome to the Milestone Scientific Third Quarter 2021 Business Update Call. At this time, all participants are on a listen-only mode, and the floor will be open for your questions and comments following the presentation. It is now my pleasure to return the floor over to your host, David Waldman, with Investor Relations. Sir, the floor is yours.

Good morning, and thank you for joining Milestone Scientific's Third Quarter 2021 Financial Results Conference Call. On the call with us today are Ariane Hoverhals, Chief Executive Officer, and Keisha Harcum, Controller of Milestone Scientific. The company issued a press release today, Monday, November 15th, containing third quarter 2021 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 30th, 2021. Before we get started, we'd 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 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 milestones control. Some of the important factors that 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, the milestones periodic filings with the Securities and Exchange Commission, including without limitation milestones report on Form 10-K for the year ended December 31st, 2020, and milestones report on Form 10-Q for the third quarter ended September 30th, 2021. The forward-looking statements made during this call are based upon management's reasonable belief as of today's date, November 15th, 2021. 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 Aryan Hoverhals, Chief Executive Officer. Please go ahead, Aryan.

Thank you, David, and thanks to everyone for joining us today. I'm pleased to report continued revenue growth for the third quarter as we achieved a 69% increase in revenue to $2.1 million versus $1.2 million for the same period last year. This growth reflects the continuous strength of our dental division as dental offices continue to reopen around the world. Additionally, our dental division continues to generate solid cash flow on a standalone basis. At the same time, we are starting to see the results of our aggressive sales and marketing initiatives within the medical segment. As we have discussed previously, we have pulled back on some of our sales efforts to preserve cash during the pandemic. However, hospitals have begun to meet with our sales representatives and international distributors. And during the second quarter, we really kicked off an aggressive sales and marketing push. We have invested heavily in our new sales force and now have 11 full-time experienced sales representatives in the field that are calling on hospitals every day. Of course, it's not only about recruiting the right talent, but more importantly, developing the sales team and monitoring its performance closely on a daily basis. At the same time, we've invested heavily in our marketing initiatives to build brand awareness for the Compuflow epidural and calf check system and provide our sales representatives with the tools to be much more effective, including training videos, corporate brand video, educational literature, digital marketing materials, and much more. These efforts are paying off as our sales pipeline is now more solid than at any point in the company's history. And the feedback from physicians, hospitals, and major healthcare system has been positive, given the safety and economic benefits of the CompuFlow Epidural System. As an example, we were recently selected to supply a CompuFlow epidural and cath check system throughout Florida's Memorial Healthcare Network. The first hospital within this health system, Memorial Regional Hospital, has begun using the CompuFlow epidural and cath check system. Memorial Regional Hospital is one of the largest hospitals in Florida. We look forward to expanding ourselves across the other hospitals within their network, which includes the Joe DiMaggio Children's Hospital, Memorial Regional Hospital South, Memorial Hospital West, Memorial Hospital Miramar, and Memorial Hospital Pembroke. More importantly, each hospital we add provides strong validation of the instrument and provides referenceable accounts making it easier to open up subsequent hospitals. As we sit here today, we are in advanced discussions with a number of premier hospitals and large healthcare systems, which we look forward to announcing in the future. Turning to our global efforts, we have added three new international distributors for our CompuFlow epidural instrument. We are pleased to expand our reach in Canada with the addition of Andal Medical, in Slovenia with Sano Labor DD, and in the United Arab Emirates with new Al Farwania surgicals and medical equipment. These are important global markets, and each of these distributors brings extensive relationships for introducing medical devices within their respective territories. I mentioned earlier our investment in marketing. In addition to helping our internal sales force, these new collateral materials have been very helpful in opening up new distributors as we are able to equip them with all the information they need to open up new sales channels. It's important to note that Milestone has traditionally been a research and development focused organization. In the short time since I joined the organization, we have overhauled the sales organization. We are setting high performance standards for our sales team, and I believe we now have the tools in place to make this a truly commercial organization. In speaking directly with our customers, our mission to establish our technology as the new standard of care in epidural anesthesia for labor and delivery has been further validated for me. This has been a long road to get here, and we faced setbacks due to the pandemic. But similar to other medical device companies and products I've personally been involved with before Milestone, it often takes years, several years, to properly seed the market. I believe that we are reaching the point that shareholders should start to see the results from all of these efforts, and we look forward to creating significant shareholder value in the months and years ahead. The market for these instruments is substantial, and given the nature of the disposables, our business model is largely built around a high-margin recurring revenue model. Not only is this a good model for us, but it also provides a strong return on investment for the hospital, as the CompreFlow epidural system has been shown to significantly reduce the total cost per hospital stay. This does not even factor in the potential liability for both hospitals and physicians. This is because the physicians and hospitals will now have a clear choice to use the CompuFlow epidural system and instruments or continue performing epidural procedures using the traditional and antiquated technique. We expect this potential liability will be magnified as we gain broader adoption of the instruments. Our CompuFlow epidural system offers objective detection of pressure changes to verify through loss of resistance and confirm epidural space within minutes. The clinical and safety benefits of the CompuFlow epidural system are backed by extensive published clinical data demonstrating significant reductions in epidural punctures and complication rates. We expect to announce additional publications that further reinforce the clinical benefits of our technology. So to wrap up, we have overhauled our sales and marketing initiatives and have brought on experienced sales executives to capitalize on the market opportunity. We are also seeing a more normalized environment following the height of the pandemic and are realizing the benefits of our efforts with growing demand and displacement of our instruments. We are starting to achieve the ambitious goals that we outlined in the past and intend to continue on this trajectory with a solid sales pipeline and additional discussions on the way. At this point, I'd like to turn the call over to our controller, Keisha Harkin, to go over the financials in detail. Please go ahead, Keisha.

Thank you, Arjun. Total revenue for the three months ended September 30th 2021 was approximately 2.1 million versus 1.2 million for the same period last year dental revenue increased approximately 836 000 due to the reopening of dental office throughout the country the rest of the world including china medical revenue increased approximately 26 000 as we added new distributors and begun to penetrate hospitals with the company flow epidural instruments and the company expects this trend to continue as it anticipates adding additional hospitals in fourth quarter 2021. Revenue for the nine months ended September 30th, 2021 was approximately 7.4 million versus 3.2 million for the same period last year. Dental revenue increased approximately 4.1 million for the nine months ended September 30th, 2021 as compared to the nine months ended September 30, 2020. Medical revenue increased approximately $108,000 for the nine months ending September 30, 2021 compared to the nine months ended September 30, 2020. Gross profit for the three months ending September 30, 2021 was $1.4 million or 65% of revenue. versus $836,500 or 67% of revenue for the three months ending September 30, 2020. Gross profit for the nine months of 2021 was $4.5 million or 60% of revenue versus $2.2 million or 68% of revenue for the first nine months of 2020. The decrease in gross margin is due to an increase in sales to China, which has a lower gross margin. Operating loss for the three months in September 30th, 2021 was approximately 2 million versus approximately 1.5 for the three months in September 30th, 2020. Operating losses for the first nine months of 2021 was approximately 5.8 million. versus approximately 6.3 million for the same period last year. Net loss was approximately 2 million or 3 cents per share for the three months ending September 30th, 2021 versus net loss of 1.5 million or 2 cents per share of a comparable period for 2020. Net loss for the first nine months of 2021 was 5.7 million or 8 cents per share. versus net loss of 6.3 million or 11 cents per share for the comparable period in 2020. Now I would like to turn your attention to the liquidity and capital resources. As of September 30, 2021, the company had cash and cash equivalents of 14.5 million and working capital of approximately 15.7 million versus cash and equivalents of 14.2 million and working capital of $15.7 million for December 30, 2020. At this point, I'd like to turn the call back over to Arjun.

Thank you, Kecia. As Kecia mentioned, we continue to maintain a strong balance sheet with approximately $14.5 million of cash and cash equivalents as of September 30 this year, which provides us sufficient funds to continue to execute on our business strategy. It's also important to note that we continue to carefully manage up our expenses. Although cash used in operating activities for the third quarter of 2021 increased by approximately $456,000 compared to the second quarter of 2021, $356,000 of this amount was directly related to the development of a new instrument and disposables, which will be introduced in 2023. In summary, we are witnessing growing interest in our CompuFlow epidural instrument and CAT-Check 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 continue to pursue our goal. aiming at becoming the new standard of care for epidural procedures in labor and delivery. We remain committed to driving shareholder value, and with a solid sales pipeline, expanded sales force, and increased interest in adopting our products, we are encouraged by the outlook of the business. I'd like to thank you for joining the call today and we look forward to providing further updates as developments unfold. At this point, we would like to open the call up to a few questions. Operator?

Ladies and gentlemen, the floor is now open for questions. If you have any questions or comments, please press star 1 on your phone now. We ask that you limit yourself to a few questions to allow for other parties' time to ask their questions. We also ask that while posing your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality. One moment while we poll for questions. Your first question is coming from Anthony Vendetti with Maxim Group. Your line is live.

Thank you. Arjun, I was wondering if you could talk more about the Florida Memorial Healthcare Network in terms of How many hospitals are in that network? And just talk about the progress within that network and how you see that rolling out. And then on your disposable that you're going to or expected to introduce in 2023, what specifically is that disposable for? And, you know, what's the pricing for that relative to your prior disposables?

Yes. Thank you, Anthony, for your question. Absolutely. As we speak, our sales team is, of course, not only focusing on the first hospital belonging to Memorial Healthcare Systems, as we have commented on in the media release that we did a couple of weeks ago. There are four additional facilities at the hospital belonging to the group. that we are currently visiting and also have discussions with to further expand and increase the adoption and the penetration of our technology within that group. So that's definitely, we are very pleased. Like we said, it's the largest hospital, one of the largest hospitals in Florida, and we are very pleased that we have that opportunity to further enhance our penetration and adoption. As to the second part of the question, I prefer not to give any additional details on that. We will make the announcements of the new instrument and disposables at a later stage. Also, it's too premature to discuss about any pricing or pricing ranges, as things can always, you know, happen between now and the beginning of 2023. Sure.

And then just to follow up on the The hospitals, obviously you also announced one in Canada and another one internationally. So you're expanding your reach, but you have 11 sales reps now. What's the expectation as much as you're able to share with us in terms of either a quota in terms of hospitals, they're expected to sign up in 2022. Or is there a sales quota in terms of, in terms of dollars for, for these, um, 11 sales reps?

Yeah. So, um, you know, we still are in 2021, so, uh, I'm still focusing short term, uh, what we can achieve with hospitals that are placing orders, uh, within this quarter, uh, prior to move, uh, into 2022. For obvious reasons, you know, I cannot share what the sales quota is for the 11 sales reps that are primarily focusing in the U.S. market, in the domestic market. As you know, we have internationally, we use a distribution network, so we do not have a direct sales force on the ground. But rest assured that they have their ambitious customers sales targets and quotas, but I do not want to give any further details what these quotas are going to be or what they are. Also not giving any forward-looking statement of what the expectation for the medical business would be in the year 2022.

Understood. And then just last question on the utilization. For the systems that you have in place, Um, what are you seeing in terms of, of the utilization, uh, trends right now at this point?

Yeah. Thank you for asking that question, uh, because I did not comment on that, but, uh, like I said in the, in the previous call, um, you know, I'm, I'm extremely pleased with the talent that we have in our team in particular, uh, the new vice president of sales that has an extensive experience in anesthesia and in particular, in the chronic pain market. As we speak, and in the last couple of weeks, we have been really increasing our activities and our sales calls also into, call it the ASC, so ambulatory surgical centers, as well as private pain clinics, because our technology could also be used in these clinics for the administration of pain relief procedures and medication. So in other words, instead of only being dependent on our technology to be used in epidural analgesia during labor and delivery, I would like to also have the opportunity to be more flexible in moving into another segment of the market. where the, you know, the sales cycle is shorter, where you do not have large or long decision-making process with value assessment committees and whatsoever in these private clinics. So I'm very positive and encouraged about the initial response that we also got from medical doctors within the pain market segment.

Okay, thanks for that. I'll jump back in the queue. Thank you.

Thank you, Anthony.

Your next question is coming from James Twilliger from Northern Securities. Your line is live.

Yeah, good morning. Can you hear me okay?

Yes, James. Good morning.

Excellent. Thank you. A couple quick questions. First of all, on gross margins, they popped up sequentially, and it was a good number. Was it a product mix issue? Anything there on the gross margin side that you can comment?

Yeah, it's not so much the product mix issue. I think what has happened in both the second and the previous quarters is that compared to previous years, the influence of the revenues in China have, you know, the pricing is different for the Chinese market. They have put pressure on the gross margins, but nothing alarming to that extent.

Okay, okay, great. And then Just looking at my model R&D in terms of expenses, which is great, kind of increased here sequentially a little bit. Is there anything on the R&D? I know you talked a little bit on some of the things you're working on. Is there any additional comments you have about the increase in R&D expenses?

No, the only additional comment I want to make is what we have said in previous calls. The beauty of our technology is that it can be used in any different other area where the hypodermic syringe is used. And I think I mentioned that on the previous calls as well, that the available funds that we are having, we are investing in the right sales and marketing activities for both dental business and the medical business. But even more importantly, we also are looking into areas where we can further expand our platform for the use of our technologies. So, you know, we are looking at different products, both in medical and in dental, to make improvements where needed, and they can be smaller or they can be larger. But like I said, I do not want to preempt on my statement of the new instrument and the disposables that we are bringing in 2023.

No, I think it's great that you're ramping up the R&D spending, so I appreciate that. And then my last question is really, For a lot of my other companies, they got hit pretty hard with the COVID Delta variant, especially with Florida and Texas and delaying procedures, and it was very bad in those two areas. You've got some great clients in Florida and in Texas that you're trying to work with. Did the Delta COVID variant negatively impact you at all in terms of trying to take additional market share within those systems, or was it kind of a non-event for you at this time?

Yeah, no, thank you for that question. I think it's an important one. To be honest with you, my personal opinion when the Delta variant, you know, sort of came along, I was expecting that we, not necessarily throughout the entire United States, but in particular in those states that you mentioned, that we would get a setback. However, surprisingly, to that extent, we were able to get the purchase order at the hospital in Florida. Also throughout this year, we were able also to get the second facility at UTMD. But definitely what I can share with you, the process was delayed in getting the right paperwork in front of us signed by the hospitals to get these you know, these purchase orders and internal steps that we had to fulfill to get them in place. Now, it's very difficult to see what the future development is going to be and what the Delta variant or the pandemic, what kind of damage, potential damage that might cause in the future. In Europe now, there is research of the pandemic again, so I see that a number of countries that we are in are in lockdown. But at the end of the day, based on the activities that I see from my direct sales team, we are still able to come in front and to get in front of the medical healthcare providers, being it in a hospital environment or in an ambulatory surgical center environment or in a private pain clinic environment.

Well, that's great news, especially operating under these conditions, which are out of your control. And then my last question very quickly, and I was looking at the queue, you don't see, I mean, your supply, you're very comfortable with your supply chain as it stands as of today. I mean, a lot of companies are having problems with supply chains, but you seem to be well positioned.

Yeah, absolutely. I mentioned it also in the previous quarter earning call. The issue here is not manufacturing. There's no manufacturing issue or there's no capacity issue at all. But of course, we are definitely also facing the logistic challenges with the containers, absolutely. but we have taken our measurements in place well in advance to mitigate that risk. So to that extent, what you see then also is that our inventory levels are currently lower than what they normally are, but there is no reason for any alarm or a red flag. The situation is under control.

Well, great. Thank you for taking my questions. I'll jump back in queue. Thank you very much.

Thank you.

As a reminder, ladies and gentlemen, if you have any questions or comments, please press star 1 on your phone now. Your next question is coming from Leslie Almetz. Your line is live.

Okay. My name is Leslie Connitz, actually, but thank you for that. At the last conference call, I asked about the profitability of Milestone. And your reply was you foresaw profitability in 2022. Does the accounting numbers from the last conference call to this conference call indicate that we're on the right track towards profitability?

Well, I don't think that I mentioned that we will be profitable in next year in 2022. I said in the previous earning call that our ambition would be to become profitable in the next coming years. Now, it all depends on what I also mentioned in the last call. It all depends on the uptake and creating the basis and the baseline of a number of hospitals that are using our technology. So it really is about increasing the adoption and the penetration in the hospital settings. Secondly, it all depends on the macro economic environment, how that will develop. But definitely, we are making steps in the right direction. But I will not promise you that during the year 2022 that the medical business will be cash positive to that extent.

Thanks for that clarification. I have one more question. What's the most significant barrier that you have to address to gain profitability? Sorry, say that again, please. I couldn't hear the question. Apologies. What's the most significant barrier that you have to address to gain profitability?

Well, I think it's all about, you know, we make the investment in the sales team, and it's all about the acceleration and the exponential growth on the revenue side, right? So it all depends on, like I said earlier, Q3 and Q4 this year is very important for us to... to create that baseline. And then in 2022, it's all about acceleration of getting recurrent revenues, increasing the penetration of the baseline that we have created, as well as adding additional new customer acquisitions that further will support and will drive the growth of the medical business. So those two, I think it's not related to the fact whether hospitals you know, are willing to invest in our technology. I think what we hear from now and also like I said in my call today and in my comments is that the pipeline is robust. It's very solid, more than ever in the history of the company. So it is all about execution. So I do not even see that as a barrier. The main barrier could be if something happens again with a pandemic or anything like that. But I'm very encouraged of what I'm currently seeing and I'm also very encouraged about the future development of our company.

Your next question is coming from Howard Yeager with Newbridge. Your line is live.

Hey, how are you? I'm doing well, Howard. Thank you for

I was just wondering if you could comment a little bit on the Salesforce pipeline, where they are in reference to the pipeline now that we have 11 reps in place?

Yes. It's a very interesting question, Howard, and thank you for asking that question. The comment that I want to make is instead of throwing out numbers, But we have multiple, I would say we have multiple hospitals where we are in advanced discussions in getting a PO this year. Now, I'm not going to comment on whether that is 10, 20, 30, or 40, because you always know that things take time. But I am positive and encouraged about what I see What I can tell you is that the sales pipeline has never been that solid, has never had the quality that we are currently having compared to previous years or in the last year. So I'm positive about that, and I'm positive about how the sales team is really focused on driving the company forward. Absolutely.

And is this for both products, would you say? No.

Well, for both products. So the sales force that we are having in place is primarily and only focusing on the medical business. The sales force is not focusing on the dental business. In the dental business, we have taken a number of initiatives of helping the distributors in generating leads. We are looking into and have had some good discussions and also already some collaboration with what we call dental service organizations, group management, platform companies that we are able then to put in front of the distributors, thereby can increase the lead generation. You know, that strategy of only distribution related, we are also expanding that into other areas to create more corporations with different type of companies within the dental community.

Okay, perfect. And look, I just want to say, and just speaking for my team, I think you guys are doing a great job. You know, you gave a great outlook. I think you guys are executing on the plan. And all I can say is just keep up the good work.

Thank you, Howard. I appreciate it.

Your next question is coming from Bill Stein with Celadon Financial. Your line is up.

How are you, John? How are you?

I'm doing well, Bill.

I just wanted to ask you, are you doing any work as far as attracting the pain management groups, not just the hospitals, but the pain management groups in using the device? And if you are, is the question there, is it an insurance thing or is it a client thing as far as them using it versus just going after the hospitals?

It's an excellent question, and thank you for asking that question. Absolutely. Not only, you know, we are marketing activities, but we are actively engaged and participating in the discussions with different call it national pain organizations. As an example, we have also been in contact with education organizations where we focus on the training, enhanced training and education for CRNAs, both in anesthesia for labor and delivery, but also the national organizations. We are in discussions with the Patient Safety Foundation in anesthesia. We have been at the recent American Society of Anesthesia meeting in San Diego, it was, where you meet, let's say, also people and medical doctors that are focused on the pain, on the private pain clinic. So absolutely. Now your second question is an important one. The reimbursement code is important, absolutely. As we speak, we are looking into further evaluation of how we could position our technology within that whole area of reimbursement code. As you know, fluoroscopy is actually used in the private pain clinics, and it is not so much the application of the steroid It's more the use of the technology which triggers the PCT code, right? Now fluoroscopy, in my own discussions with owners of private pain clinics, fluoroscopy is a high-cost item for the private pain clinic. It's not only the cost of the equipment or the amortization of the equipment, but also using a radiology assistant that has to come three to four hours every day be able to do the fluoroscopy for these patients. And then also on top of that, you know, those clinicians, they need to have, at the age of 40, cataract surgery because of their exposure to the radiation. Now, we have had, like I said, based on my VP of sales, we have had several discussions with these private pain clinics. and there is definitely a level of interest for our technology and there's a need there's a place for our technology to be used and i also believe absolutely if we would have a pct code then it will definitely be a game changer but there's also place for our technology without a pct code but then the magnitude is somewhat lower than, for example, if we have a PCT cut. So we are working hard in further investigating that and being able to position ourselves in that marketplace.

That's great to hear. I just wanted to ask you, how confident, as far as the hospitals, do you expect you know, kind of a domino effect where, you know, certain hospitals start saying yes? Do you believe that, you know, it certainly sounds encouraging from what you said as far as the sales team working on all these prospects, but it's been, you know, slower than we, you know, everybody wants. But, I mean, how confident can you expect the domino effect on hospital deals, would you think?

Yeah, I'm a very ambitious and positive person. No is no option for me. And I've always said it for myself, this is my personal opinion, I do believe in that domino effect. And it's not only, let's say, the adoption of the hospitals, but it is also related in what we are doing in the background. Like, for example, I believe and I strongly feel that the responsibility that I have, that I have to bring to the company, is also to educate, let's say, the society, like educate women being pregnant at the age of 18 to 40, 45 years, about the associated risk factors with these procedures. Our role, our task is to educate them. There was a recent study done by Stanford publication where the adverse events from epidural anesthesia expressed in severe headaches, and these headaches being more than just a migraine, but really terrible headaches for the woman. which also is interrupting the breastfeeding cycle for the woman and her child. Now, what we tend to do these days at the hospitals for a patient or a woman undergoing an epidural analgesia, we have to sign a thick bunch of or a number of papers from liability issue. So my point is just why do we allow that to happen if there is technology available that can avoid that situation and that can improve healthcare outcome, that can improve and enhance the safety of the woman and the child and actually make this, you know, giving birth really one of those moments in life that the woman and the child will never ever forget. I think that is our That's our responsibility. That is our goal, and that is where I want us, my team, the entire organization, and the company to play a very important role.

Thanks so much, and good luck. You're doing a great job there. Thank you.

Thank you so much.

There are no further questions from the lines at this time. Thank you, ladies and gentlemen. This concludes today's event. You may disconnect at this time and have a wonderful day. Thank you for your participation.

Thank you very much, and thank you very much for your attention, and please stay safe. All the best.