Milestone Scientific, Inc.

Greetings. Welcome to the Milestone Scientific 2022 Year-End Financial Results and Business Update Conference Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. 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 Ariane Haberhals, Chief Executive Officer, and Peter Milligan, Chief Financial Officer of Milestone Scientific. The company issued a press release today, March 31st, 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 at 212-671-1020. The company's management will now provide prepared remarks reviewing the financial and operational results for the year ended December 31st, 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 milestones 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 market requirements and standards and the risk factors detail from time to time in milestones, periodic filings with the securities and exchange commission, including without limitation milestones report on form ten K for the year end December thirty first two thousand twenty two. The forward looking statements made during this call are based upon management's reasonable belief as of today's date. March thirty first two thousand twenty three 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 Arjen Haverhals, Chief Executive Officer. Please go ahead, Arjen.

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 CompuFlow epidural system. Most importantly, we were successful in seeding the market across a number of key hospitals, healthcare 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 510K FDA clearance for use of the CompuFlow 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 lumbar 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 CompuFlow 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 approval increased our accessibility to the total addressable market for epidural analgesia. Within just two weeks of receiving the thoracic clearance, we announced that we commend sales of CompuFlow epidural disposables across three pain management clinics in Colorado. Adoption of the technology by these clinics follows a successful evaluation process by Dr. Brad Sisson, MD, a recognized pain management doctor. Dr. Sisson initially conducted several cases using the CompuFlow epidural instrument in which he reported 100% success. The evaluation included procedures within the thoracic region of the spine. Similarly, Dr. Demesman, an interventional pain medicine physician, has begun using our technology within his practice at University Pain and Spine Center following a similar successful evaluation. As a result, we commenced the sales of our CompuFlow epidural disposables across the University Pain and Spine Center in Somerset, New Jersey, which operates in another seven offices across New Jersey and New York. We remain encouraged by the interest in our epidural instruments by anesthesiologists and pain management providers, especially for patients with complex anatomy and difficult cases that involve the thoracic and cervical thoracic junction. The further evaluation of our technology by these physicians illustrates their commitment to incorporating the latest technologies to improve patient outcomes and safety. Another important milestone in 2022 was the issuance of a category three CPT code, which became effective on January 1st of this year. We believe this would potentially allow billing and payment pathways for healthcare personnel who choose to use our technology for coverage and discretionary payment by payers such as Medicare and Medicaid, as well as commercial health plans. This code will be a focus of ours in 2023 and is expected to play an important role, especially in private pain clinics where administration or financial decision-making will be made easier, thereby potentially helping accelerate our commercial rollout. In addition, we were recently granted registration with the U.S. Government System for Award Management, also known as SAM, which is a key step in the overall governmental decision making and payment process. A SAM registration is required for entities to bid on contracts and conduct business with Department of Defense and the Department of Veterans Affairs, Indian Health Service, and other government agencies. We are actively pursuing U.S. federal supply service approval for the CompuFlow epidural instrument, which, if granted, would provide uniform pricing and reimbursement across government agencies. In addition to our direct sales channel, we are also expanding our network of distribution partners to assist in further adoption of CompuFlow epidural systems. We recently added a new international distributor in Greece and re-engaged with our domestic partner, Clinical Technology Incorporated, a leading specialty distributor of medical products in the Midwest and East Coast regions of the US. Each of these distributors brings relationships within key global markets and proven track records, introducing medical devices within their territories. We look forward to announcing additional international distributors as we advance our commercial rollout. So to summarize, we are continuing our efforts to seed the market with our technology among key physicians, which we believe will ultimately translate into widespread adoption. We remain committed to our goal of establishing the CompiFlow Epidural Instrument as the new standard of care in epidural anesthesia by providing patients with effective pain relief while reducing the risk of complications. Turning now to our dental segment, we made a number of key changes to our sales and marketing strategy this past year that we believe will enhance our long-term growth. In the United States, we launched a new online portal for U.S. dentists to order the STA single-tooth anesthesia system instruments and handpieces. This new site went live on January 3, 2023. We ended the agreement with our prior distributor at the end of 2022. This change in U.S. distribution strategy resulted in lower fourth quarter 2022 sales as the prior distributor wound down its operations and did not preorder handpieces for the first quarter of 2023 as they did in the fourth quarter of 2021. Despite this short-term impact, we expect our new direct online channel will provide us with a closer and direct relationship with our customers, which we believe will result in better follow-up and improved margins. In turn, we believe this strategy could result in an increase in dental sales at higher margins in the US market in the coming quarters. Meanwhile, we continue to work closely with other channel partners for our STA instruments, especially in specialized areas of dentistry, such as implant dentistry and aesthetics, as well as large dental groups, also known as dental service organizations, or DSO. Offsetting the temporary weakness in domestic sales due to our transition to a direct sales model we witnessed continuous growth in international sales, excluding China. As part of our strategy to grow our dental business, we have placed a major emphasis on entering new markets and expanding our penetration within existing international markets. Specifically, we have added new global distribution partners. For instance, we recently granted Technica Health Technologies exclusive distribution rights to market milestones FDA single-tooth anesthesia system in Brazil, one of the three largest world markets in dentistry. In fact, Brazil has a population more than 200 million people with over 240,000 dentists. We also recently appointed Sweden and Martina as our exclusive distributor in Italy, France, Spain and Portugal. We believe that Sweden and Martina is an ideal partner given that deep penetration within these key European markets, which represent a combined population in excess of 180 million people. We look forward to announcing additional international distribution agreements as we continue to build our network across Asia, Africa, South America, and Europe. At the same time, we continue to carefully manage our expenses while investing in sales marketing and new product development along with analyzing new areas for our technology. So to summarize, we believe that through our new sales strategy in combination with our increased marketing efforts, we aim to further grow the dental business in the coming years. Our dental business continues to generate positive cash flow on a standalone basis. As we continue to grow our revenues, we expect to benefit from economies of scale due to the recurring nature and high margins on our disposables. At this point, I'd like to turn the call over to our Peter Milligan, Chief Financial Officer, to go over the financials in detail. Please go ahead, Peter.

Thank you, Arjen. Toll 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 the 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 a 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 or 61% for the prior year. Year-over-year decline in gross profit was driven by lower revenue and the impact of a approximate $400,000 non-cash inventory reserve related to medical products. Operating loss for the year was approximately $8.8 million versus $7.4 for the prior year. And then the loss to common shareholders was $8.7 or $0.12 a share versus a $6.8 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 and working capital was nearly 10 million. At this point, I'd like to turn the call back over to Ari.

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 31st, 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 instrument, 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 instrument and handpiece ourselves in the coming years. In addition, we remain confident in the market potential of the CompuFlow 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 a streamlined operating structure, we believe the future is bright. We are excited about the recent 510 FDA clearance for use of the CompiFlow 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 implementation 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?

At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment while we poll for questions. Your first question for today is coming from Anthony Vendetti at Maxim Group.

Thank you.

Ari, and 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, you know, I know that impacted sales in the fourth quarter. Can you talk about you know, the uptake that you're seeing or the traffic numbers that you're seeing in terms of your onsite sale? And do you feel like that transition is complete, all the customers are aware of it, or do you think it'll continue to play out over the next couple quarters?

Good morning, Anthony, and thank you for your question. I would be delighted to shine some more light on this 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, you know, 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, you know, significantly increase to different levels than historically within the company. Was there a risk in that operation? Absolutely. But, you know, I made the decision or we made the decision that there was no other opportunity and in particular for the mid-term 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 had seen that but I would say we 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 pick-up has been and how the take-up has been. I can, 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 that this has been the right decision for the company moving forward, which I believe that in part, you know, 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 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, thank you, Ari. And then maybe as we shift to the medical side, you've had a couple of recent events, including the 510K clearance for the CompuFlow epidural system in the thoracic region, including the cervical thoracic junction, which obviously that'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. It's a much shorter sales cycle. How do 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?

Yeah, thanks for the question, Anthony. personally I believe you know without sounding arrogant or bullish but I do believe that the company has now better tools in the toolbox so to say compared to one two years ago and and the main reason is 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&B department is much longer. It's six to nine months without, let's say, the larger hospitals where it can even be longer. And remind ourselves that a year ago, we made an attempt to go in the crisis 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, the 510 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 private 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 the whole reimbursement environment and as a result of the 510 K approval we also were able to get the official approval of using our system within the thoracic cervical spine and I can share with you that since that announcement, there are a number of hospitals that not only we have contacted but also have contacted us because to your point, the unique selling proposition of our technology within the cervical thoracic spine is much better understood and higher than in the lumbar because of the morbidity rates in lumbar being 5% in the thoracic being 17% and in the cervical spine being 30%. But in addition, the CPT code, our code, our temporary code, what we should not forget is it is an additional code to existing codes, including cervical and thoracic. So, for example, the two clinics that we announced, they have used our technology in the thoracic spine and the cervical spine. And as we speak, they have submitted the paperwork also to their local insurance providers, which is a mix of Medicare and private healthcare insurance providers. And now, you know, we wait for feedback of the insurance providers, whether they accept it or whether they deny it, and then we help the clinicians through a service network to have these discussions with the health insurance providers it's of most important to understand the following we as a company and our management team is in no way entitled or allowed to give direct recommendation to the clinician what the price of the reimbursement would be or having direct relationship and communications with the healthcare insurance providers. So during the fourth quarter, the third and the fourth quarter of last year, we have prepared exactly what we are currently doing right now. Now, to your last part of your question, do I believe that that will have an impact the medical revenue potentially, yes, it will have an impact on the medical revenue. It remains to be seen what the magnitudes will be on the revenues that we have projected internally. So in parallel, just going one step further, it is a combination of both the FDA approval as well as also the potential access to to our federal supply services or the governmental business. I'm not saying that we are only focusing on the governmental side. Every time we have to do our work and we have to execute on the plans that we have provided. But I do believe that, and that's the goal and the aim of management of this company, that we should see results of the pathway that we have chosen and of the initiatives that we have undertaken.

Okay, no, that's great. I think just as one last follow-up, you know, because I spoke to a KOL on the pain center who was very knowledgeable and said, you know, he said he's going to be recommending this to his colleagues because it's pain-free. You get an exact location where, you know, 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 healthcare 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 CompuFlow 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 the type of person that I only announce news when it is valid, when it 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 two 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, you know, we'll send in the documentation to the healthcare insurance providers, being it public or privately owned. That's one cycle. 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, 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 during 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, you know, we can address that entire market. Like the cervical thoracic junction is about what we always say is twice then the Lombard 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 you know under penetrated 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.

Okay, thank you very much for all that color, Aryan. I appreciate it, and I'll hop back in the queue.

Thank you, Anthony. Have a good day.

Once again, if there are any questions or comments, please press star 1 on your phone at this time. Your next question for today is coming from John Korb, a private investor.

Good morning, Ariane. How are you today?

I'm doing well, John. How are you?

Good. Anthony answered, you answered a lot of the questions that I had through Anthony's 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 were waiting for this approval. I didn't even know that approval was on tap. Are you waiting for other types of approval from the FDA or is this it?

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, you know, diseases, therapies, et cetera, that are in the spinal region. So we can play a role in spinal cord stimulators. We're looking into, you know, 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 is 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, you know, a potential new submission to the FDA. You know, 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 all 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 vibe 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 sidetracked, but I hope that I've 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, of trading after that approval was granted. But 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 are appreciative of the activities that are ongoing. So also, what we are currently doing, in particular in the dental market space, You know, 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 two weeks of the instruments that we sold ourselves direct that our team has very yeah, 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 dentist 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.

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

No, we have three 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 has a footprint in 22 states in the United States. And for the time being, you know we are looking at more at more partners because we all know and we all are appreciative that a direct sales team is putting yeah sufficient pressure on a balance sheet so to say from a direct cost point of view now of course you can say you know going with a distributor it will hurt your margins absolutely but that is controllable through pricing or to other activities but you know 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 in a good place and a good spirit

Okay. I'm going to end with asking you a 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 where 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 a possible scenario you're looking at, or is it going to be more of a slow, steady rollout? And when might we really gain 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 one day of all of a sudden 2 million shares traded. There's a lot of people paying attention to Milestone Scientific. So what, are you more encouraged than ever for this year or are we just, you know, very tentative still or what's your current thinking that you can comment as fairly and as best you can?

Yeah, 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 the snowball effect would be when we hear back from the first healthcare insurance providers that would accept and would set a pricing on the reimbursement. That would be one thing. Another 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 the 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 a 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're not going to elude on that. And of course, for the company overall, you know, we are looking at operations and the financial well-being of the company to secure you know 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 on 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 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.

Great. Well, thank you so much, Ariane, for your continued hard work and best wishes. Thank you. Okay.

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

Good morning. Good morning, Michael. 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.

The expectation on the cash burn this year, the goal is that 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 But I would say also 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 cash 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. Just to be 100% sure, what I said was that the doctors, the two clinics that we have been working with and that we have announced, and we are adding more clinics, that these doctors had sent in the information to the healthcare insurance providers, and then, you know, 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 six weeks out of our control, depending on the healthcare 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 pay-per-click, 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 healthcare insurance providers. Now, without promising anything, I'm just sharing what my expectation is, so this is just me shining my light on that. I do hope, and my ambition is, you know, that within the quarter at least we get some initial feedback from these healthcare insurance providers. That's all I can say, right? And, you know, 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 healthcare insurance providers because when we increase the volume and the healthcare insurance providers see that more clinicians are sending in the coding and the billing papers, it will potentially also first enhance the speed of feedback, B, create an increased awareness of the healthcare insurance providers, and C, hopefully facilitate a decision-making process at these healthcare 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 healthcare.

But I guess the takeaway, though, I heard from you is that 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 two, that there's other things in motion, that there'll be a greater volume occurring going forward at some point. Is that reasonable to say?

That's absolutely correct.

Okay. And then the last question, and I thank you for your time, the SAM approval, what's the potential timing? 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, you know, if a VA, sees that we are on the FSS or 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 of the timing of that? How long did that take?

Yeah, 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, yeah, in the near future. And potentially, I believe that that would come perhaps somewhere within the quarter, within the second quarter.

Well, that sounds very promising.

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

Okay. Well, I thank you for your time, and continue the good work. I appreciate it.

Thanks a lot, Michael. Have a good day.

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'm 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 earning call, you know, we are approachable and I wish you a good Friday, 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.