Milestone Scientific Inc (MLSS) 2020 Q4 法說會逐字稿

Greetings. Welcome to Milestone Scientific's end of year annual conference call. (Operator Instructions) Please note, this conference is being recorded.

I would now like to turn the conference over to your host, Natalya Rudman with Crescendo Communications. Thank you. You may begin.

Thank you, Devon, and good afternoon, and thank you, everyone, for joining Milestone Scientific's 2020 Year-End Financial Results Conference Call. On the call with us today are Leonard Osser, interim Chief Executive Officer; Arjan Haverhals, President of Milestone Scientific and CEO of Wand Dental; and Joseph D'Agostino, Chief Financial Officer.

The company issued a press release today, Thursday, April 1, containing 2020 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 31, 2020. 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 plans, expected revenues and future success. These statements involve a number of risks and uncertainties and are based on assumptions involving judgments with respect to future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond Milestone's control.

Some of the important factors that could cause actual results to differ materially from those indicated by the forward-looking statements are general economic conditions, failure to achieve expected revenue growth, changes in our operating expenses, adverse patent rulings, FDA or legal developments, competitive pressures, changes in customer and market requirements and standards and the risk factors detailed from time to time in Milestone's periodic filings within the Securities and Exchange Commission, including without limitation, Milestone's report on Form 10-K for the year ended December 31, 2020.

The forward-looking statements made during this call are based upon management's response -- reasonable belief as of today's date April 1, 2021. Milestone undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

With that out of the way, we will now turn the call over to Len Osser, interim Chief Executive Officer. Please go ahead, Len.

Thank you, Natalya, and thanks, everyone, for joining us today. I am pleased to report that our revenue for the fourth quarter of 2020 increased sequentially by approximately $1 million or 78% versus the third quarter of 2020. We achieved this result despite the impact of COVID-19, which indicates that we are successfully navigating the pandemic and remain on a growth trajectory for this quarter. Importantly, we continue to carefully manage our operating expenses, reducing our net loss for the year.

With COVID-19 infections declining in certain regions and several hospitals reopening to outside vendors, we have made progress over the past year advancing our commercial efforts around the CompuFlo Epidural instrument and the CathCheck system. Specifically, we have added several new hospitals that are purchasing our disposables with prospects of increased business in the coming months.

Most notably, in the first 3 months of '21, we began selling CompuFlo Epidural and CathCheck disposables to 3 premier medical centers: Regional Medical Center, a premier regional health care system in South Carolina; the University of Texas Medical Branch at Galveston, an institution of the University of Texas system and agency of the state of Texas; the nationally recognized Medical University of South Carolina; and the leading German hospital, the University Hospital of Wurzburg. The purchase orders received from these 3 U.S. medical centers and 1 European hospital further reinforces our confidence in the outlook for both CathCheck and the CompuFlo and the value proposition to other health care systems across Europe and North America as we strive to become the new standard of care in epidural procedures in labor and delivery.

Additionally, we enter into an agreement with Bitmedical AG to distribute the CompuFlo epidural instrument and CathCheck system as well as related disposables in both Switzerland and Austria. Penetrating the sizable Austrian and Swiss markets is an important step forward in our commercial launch of the CompuFlo Epidural system in Europe.

In October 2020, we were awarded a group purchasing agreement for CompuFlo and CathCheck with Premier, a leading group purchasing organization with approximately 4,100 U.S. hospitals and 200,000 other providers within their network. At the same time, given the sales to these hospitals, we are now expanding our medical sales force. Now that new protocols are in place at hospitals, we are better able to enter the hospitals and have commenced a number of new pilot programs. The results of our clinical trials have also been published in leading medical journals, which aids in driving market awareness and further validation of our technology. Importantly, the CompuFlo Epidural system is validated in terms of safety, efficacy and economics.

Similarly, the CathCheck technology has the potential to transform the monitoring of catheter replacement following an epidural procedure by confirming the placement of a catheter within 2 minutes versus 20 to 40 minutes using conventional methods. Our unique computer control real-time pressure sensing technology provides anesthesiologists an objective and quantifiable technique to build confidence and success.

For these reasons, we are further encouraged that our technology will become the new standard of care in labor and delivery anesthesia, replacing the present standard of care, which is the 1860 hypodermic syringe.

As we are consistently evolving our injection and drug delivery systems, we recently received 2 notices of allowance for a key patent from the U.S. Patent and Trademark Office and the notice of allowance from the European Patent Office. The first patent relates to the disposable component of Milestone's CompuFlo instrument and covers the unique interactions of the disposable assembly and the microchip security verification feature embedded in the disposables, which provides clinical and safety benefits for the patient and practitioner.

The second patent relates to our new CompuPulse System, which integrates the CompuWave technology with a manual syringe. This new technology provides an efficient and low-cost alternative for procedures where a manual syringe may suffice, while still providing the ability to verify needle and subsequent catheter placement, which opens up a number of exciting new markets and applications for our technology.

The third patent from the European Patent Office combines minimum intensity of nerve stimulation and real-time injection pressure monitoring, utilizing Milestone's CompuFlo instrument and associated DPS Dynamic Pressure Sensing technology, to optimize needle tip location in ultrasound-guided peripheral nerve block procedures, thus helping to reduce the risk of needle injury during PNB procedures. This is a large market opportunity given that the direction of the industry is to regional anesthesia.

In summary, we have been successful in commencing the first phase of our commercial rollout of the CompuFlo Epidural instrument, a key element of our sales strategy focuses on the disposable components of our system which we believe will contribute to high margins and recurring revenue. Overall, the response from both hospitals and physicians has been positive, and we are in a few trials across the country that have the potential to convert to additional commercial orders. Our sales pipeline is more robust than ever, and we look forward to finalizing additional agreements with several premier hospitals soon. At this time, we are actively engaged in hiring sales professionals to enhance the rollout in the U.S.

At this point, I'd like to turn the call over to Arjan Haverhals, our President of Milestone and Chief Executive Officer of Wand Dental, to describe the sales and marketing activities around the Wand instrument in more detail. Please go ahead, Arjan.

Thank you, Leonard. Our dental business has begun to recover as a result of successful sales and marketing initiatives as well as dental offices reopening across the country and around the world. We believe our rapid progress illustrates the positive response and growing market demand for our dental instrument. We have begun implementing our 3-year strategy to expand the worldwide global dental market. We are successfully adding domestic and global distribution partners, which reflects our new decentralized sales strategy. Specifically, we are targeting independent distributors with existing relationships within their respective territories and dental networks.

We believe we have developed a highly cost-effective and scalable platform to help drive our dental instrument and have these sales in the coming years. The goal of changing our marketing plan from a sole exclusive distributor in the U.S. and Canada to a large number of nonexclusive distributors is to increase the placement of our Wand STA instrument, and thus, the expansion of our dental disposables. We look forward to further expanding our coverage and working closely with our new distributors.

We believe that with this decentralized sales strategy in combination with our increased marketing efforts, we can further grow the dental business in the coming years. In less than a month, we have expanded our network to increase 7 -- or to include 7 independent distributors covering key markets across the U.S. plus a new distributor in Canada. These are important additions to our distribution network as we educate dental professionals on the significant benefits of our dental instrument in terms of establishing a safe environment for patients and staff during the pandemic, and importantly, supporting the growth of dental practices.

As I mentioned, we accomplished our goal of building a robust distribution network covering important territories in the U.S. and the key market in Canada through our new decentralized sales strategy. We are now accelerating our efforts into new global markets while supporting our present distributors.

At this point, I'd like to turn the call over to our CFO, Joseph D'Agostino, to go over the financials in detail. Please go ahead, Joseph.

Thank you, Arjan. Total revenue for the year ended December 31, 2020, was $5.4 million versus $8.3 million for the same period last year. Dental revenue decreased by approximately $2.9 million, which was related to the impact of the COVID-19 pandemic on the company's customers and other business partners. Medical revenue for the 12 months ended December 31, 2020, was approximately 16,000 versus 38,000 for the year ended December 31, 2019. Gross profit for the year ended December 31, 2020, was $3.6 million or 67% of revenue versus $5.7 million or 68% of revenue for the year ended December 31, 2019.

Operating loss for the year ended December 31, 2020, was approximately $7.5 million versus approximately $4 million for the year ended December 31, 2019. Net loss was approximately $7.3 million or $0.12 per share for the year ended December 31, 2020, versus a net loss of $7.5 million or $0.16 per share for the comparable period in 2019.

Now I would like to take a look and turn our attention to the liquidity and capital resources. At December 31, 2020, the company had cash and cash equivalents of approximately $14.2 million, total current assets of approximately $18.6 million and working capital of $15.7 million.

At this point, I'd like to return the call back to Leonard Osser.

Thank you, Joseph. We remain encouraged by the outlook for the business as the dental business is starting to recover. Through our new decentralized sales strategy and our enhanced marketing efforts around the Wand instrument, we believe this will increase our market penetration as we focus on the significant value drivers of our instrument, which includes safety, efficiency, and importantly, supporting the growth of dental practices. In addition, we remain confident in the market potential of the CompuFlo Epidural, which we believe will transform the industry and ultimately become the standard of care.

Importantly, we have begun selling our CompuFlo Epidural to a number of hospitals and medical centers in the U.S. and Europe. Moreover, we are building a sales pipeline, including advanced trials underway that we believe we will convert to new commercial orders. Overall, we are in a strong financial position with over $14 million in cash, cash equivalents and other short-term investments as of December 31, 2020. In addition, the proceeds from the recent exercise of warrants strengthens our balance sheet with an additional $4 million plus of cash since November 2020. This liquidity, combined with our improved cash flow should help accelerate our sales and marketing activities around both our dental and medical instruments.

In addition, we are now positioned to institute the development of both a new dental product and further increase our product portfolio in the medical sector. Once again, we believe the strength of our balance sheet provides us substantial runway to help mitigate the risk related to COVID-19 as well as accelerate the development and commercialization of other indications from our profound IP platform. We believe this technology platform is quite broad with multiple opportunities available to our company in large and underserved markets.

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 for questions. Devon?

(Operator Instructions) Our first question comes from the line of Anthony Vendetti with Maxim.

I was just wondering if you could talk, Len, a little bit about the pilot programs, how many of them -- what -- how long do you think they will last? And then the sales reps, how many you're targeting or how many territories are you targeting?

Right. Well, I'll turn that over to Arjan. But first, I'd like to say that being conservative by nature, if not politically, economically, I'd like to say that we held off any significant hiring until we were in the first couple of hospitals, which is now the case. And that's why we're expanding our sales force.

The 2 things that are generally asked -- the first things that are generally asked by doctors when a salesperson approaches them is, number one, where are the clinical studies, of which we have an abundance. But number two is where else are you? Who else is using it? So prior to going all out and hiring salespeople for the United States, we decided to, first, be successful in at least 2 hospitals. Given that, that is now the case, we are now hiring. So I'll turn it over to Arjan.

Yes. Thank you. Yes. In addition to what Leonard alluded to, of course, what we always say, the moment you are in a hospital, and that's in a way also where the work starts. So part of the sales team in those hospitals that we have received purchase orders from, their task is also to further increase the penetrations within the hospital. So that's one given. So when you have a number of hospitals increasing the penetration inside, that is very important.

In addition to the current salespersons, we have now around 4 -- or we have 4 salespeople. We're looking in expansion. And we are looking -- we are not just saying, okay, let's go in that territory or that territory. It's completely dependent on the number of hospitals and what those number of hospitals mean in terms of the potential number of epidural procedures.

So we are not going to spread out all over the country. We remain focused first on -- I would always say we draw the line from Chicago down to Dallas, Houston and East because we also need to manage the team. We want to avoid to spread us out too thin over the entire country.

The number of people that we would add, as a minimum, we would like to double the current size of the sales team. And then in parallel with the commercial successes that we anticipate for the coming year, we will further expand on the sales organization.

Okay. Great. And then just in terms of access to the hospitals, are you close to almost full access now? Or is it really on a hospital-by-hospital basis?

No. It's still a mix, but the trend is very encouraging. There are several things that are taking place. For the first, for example, hospitals that we were active in or active at more than a year ago prior to the pandemic, they said in March, let's wait, and you will hear from us when you can get back or when we allow you to become within the premises of the hospital. That is actually taking place. So that's what we see with a number of hospitals that we were discussing with a year ago, where we are now back at the table, so to say, and further getting into the process of value assessment and value-added team and value-added committee meetings. So that's one happening.

Secondly, what we also see is, in particular, in the Northeast, when I follow the news that we received a lot of hospitals are reopening again, also in particular one area, New England and Massachusetts, where they, so to say, defreeze, I would say, or thaw their capital equipment budgets. So they were frozen doing the pandemic, and that is lifted now as well.

And of course, as we have been active in a number of hospitals since the second half of last year, we are still further building up in the number of demos and trials that we are performing in the hospitals as we speak. So in addition to that, with the hospitals that we -- that already has placed or have placed purchase orders with us, we also see then an uptake and a reordering of the hospital in getting the consumables going, which is, of course, for us, very important because that's a confirmation of the business model that we choose to have.

Sure. Sure. So last question, just on the GPOs. Has the GPO relationship you have in place, has that been able to facilitate any of the meetings with the hospitals during this time? And if not, because of COVID, do you believe that the GPO relationship is going to start to be beneficial as we move through '21.

No. Absolutely. And I think the evidence is already there, to that extent. As we said in October last year, when we reached or we were awarded an agreement with Premier, the group purchase organization, I think it's definitely important for us. We were able to have -- one of the first hospitals ordering products from us was from UTMB. So University of Texas Medical Branch, which is belonging to the Premier GPO group.

Now again, it's not a given that when we have an agreement with a GPO, that sales is automatically coming. But what is important is it definitely takes away some barriers or hurdles for us to get access to the hospital. It is an endorsement that facilitates the introduction and the entrance at the hospital. We still have to do, of course, and we have to make an effort of getting the sales in. But is it important for us? Absolutely. Are we going to further looking -- look at hospitals that belong to the Premier GPO group? Absolutely. Are we going to look into other GPOs across the country? That's definitely one of the -- or part of our strategy for growth for the next coming years and period.

(Operator Instructions) Our next question comes from the line of [Gary Carol], a private investor.

[Gary Carol]. I would like to express my condolences to Eric Gilbert's family and to the Milestone family and his loss. I had the pleasure of meeting with him and visiting a hospital here locally in South Florida. So I know that was kind of tough on everyone.

So I guess my question is relating to especially Florida, as we know it's a very target-rich environment and I know that at some point, we had a lot of activity going on. So in the expansion of the sales team, are we anticipating or do you already have someone that will be repping in the state of Florida here?

Thank you for asking that question. Absolutely. As we speak, I have already had interviews with a number of candidates for Florida. This is definitely part of the expansion plan. And I leave it a little bit in the middle, whether it's going to be 1 or 2 persons for the Florida state. But it's definitely a high priority for us, also based on the activities that were undertaken a year ago, again, prior to the pandemic and also later on where we would like to, in a way, to put it in these words, to take the benefit of the initial discussions that have taken place in a number of hospitals in Florida.

And Gary, thank you very much for your condolences. Eric was not just a serious professional, but he had become a very good friend to us at the company. So very much appreciate it.

Yes. Welcome. Yes, he was a good guy. And at any rate, it sounds like you guys are on the right track as far as expanding sales. So we're going to go from 4 -- approximately 4 people to -- your guess is approximately 8 salespeople. And when do you anticipate that we would have those 8 out in the field actively working?

Yes. The sooner, the better, I would say. It is one of the key priorities and the highest priorities that we are currently are undertaking, apart, of course, of getting more hospitals in. But it goes hand-in-hand. If we want to increase our commercial platform and our commercial success, it also means that we need to invest and get more people within the organization. So these days, it's sales and it is a lot of interviews in identifying the right talent to the team.

Okay. And I guess we're still on track as far as the offering of the instrument on a -- I prefer to call it a consignment basis to remove that capital budget hurdle in a situation where the hospital doesn't have the capital budget. But once they start using the disposable, then we're willing to consign the box and upcharge the disposables. Is that still out there on the table and still something that we're actively pursuing?

Yes. We have not changed our flexible sales strategy. It has always been part of the original sales strategy. And the only thing that we said last year was based on the pandemic and to help the hospitals, we went for lending the equipment to the first hospitals versus then a commitment to a minimum volume at a premium price on the consumables. And that is still a part of our sales strategy. So that's not changed. But of course, also moving forward, we would also love to see that -- for example, a hospital has a first instrument, that we get additional sales on instruments as well.

Perhaps I can just add something here. The reason why we're saying that is important is that, that entire strategy works, like, for example, the University in Wurzburg in Germany that we announced, I think it was, yes, in the middle of the first quarter, that has not been a consignment agreement at all. That was pure purchasing or us selling the instrument through the hospital. So I think it's important that everybody understands that the entire sales strategy and the 3 different pillars we are having is actually working.

Our next question comes from the line of [Derek Rowson], a private investor.

I just had a quick question about manufacturing. I don't want to put the cart before the horse, but in terms of manufacturing, can you just give a little color on to where you're getting supplied from? Is it China? And if so, are there going to be any hurdles that you see or foresee with the political state right now with them?

Well, the instrument is -- our dental instrument is produced in the United States, outside of Chicago. The disposables will be produced in China. We've been producing disposables at the same facility for, Joseph, 18 years?

Yes.

About 18 years. And we've had no difficulty whatsoever. It's a very -- the owners of that facility include one of our major investors, who set up that factory for us so that we could get excellent pricing, which has always been the case. The people that own that come out of a Japanese company that -- where they were the upper management for a number of years of the Japanese-owned facility in Tianjin in China. So we don't foresee any problem with the facility, with the management, with the production. They're very professional. They are on a worldwide level there, as good as Germany, the United States, in the facility, which I personally visit with some frequency while I'm there.

As far as the political situation, I don't see that having any difficulty going forward. But naturally, I have no crystal ball. I'm not in the meetings between our President and Xi Jinping. But I think that will come down to pragmatic decisions based on both countries, so I don't foresee any problem in that area. You never know what happens as the regulatory agencies change things often. We have the skill set both here and there to deal with that.

So the short answer is I don't foresee any difficulty with the manufacturing either of the instruments or the disposables. We always work towards lowering the prices, doing things in a more efficient way, buying in certain quantities which will bring down our price. And our objective for the disposables will be around the 70% margin as we go forward. Nothing in that -- nothing has changed in that.

Our final question comes from the line of [John Cork], private investor.

Yes. This seems to me, in my long time association as a shareholder with Milestone, the most exciting time ever. And I'm trying to figure out what are the possibilities for the company. And you recently outlined the possible income projections if the epidural becomes a standard of care, which is pretty striking. That alone is pretty striking.

My specific question, I'm trying to figure out where the company is going, relates to your announcement on March 10 of a -- the European patent, a combination of neuro stimulation and DPS Dynamic Pressure Sensing Technology. I'm not in the medical field, so I'm not fully aware of the implications of that patent, but the market participants on the 9th or 10th seem to indicate this might be a big deal. Now I know you don't comment on market action. But that day was greeted by huge upside volume on price for Milestone.

And I'm reading this over, and I'm thinking, if that was related to this, has this particular patent opened up a whole new set of possibilities for Milestone? Or could you comment on the implications for this patent and where it might lead the company?

Yes. So well, thank you for your question, and let me try to explain that. So the release on March 10, it was, as you correctly say, it was -- we call it peripheral nerve block PNB and nerve stimulation. And why is that important? Because we always have said that wherever the hypodermic syringe is used, potentially our technology can be used.

Now in this case, for peripheral nerve block, what the Dynamic Pressure Sensing Technology would do is to avoid, let's say, intra-neural -- or the delineation, the differentiation between intra-neural and extra-neural injections. So it is similar as a positioning of the needle that we would have in the epidural.

What we also have been doing is there's clinical research ongoing, and we have been proud of that, in particular, in this area. And then to your question, why is it important? It's important for the following reason. First of all, it has proven that our technology has a role and has a place in this indication. Secondly, also in combination with what they call nerve stimulation, which is another technology used in that indication.

But thirdly, I think the -- to your words, if I may repeat them, you said, there seemed to be a high level of enthusiasm. It's also related to the addressable market size because if you look into the epidural market where we have about 11 million procedures in the U.S. alone, I think about 30 million procedures on the global level, in peripheral nerve block, that is 41 million procedures in peripheral nerve block.

So our technology to be used in a different and in a new area in association with a larger potential market or a larger addressable market, that might have been the reason why some of your colleagues attending that meeting were enthusiastic. But for us, it is an important confirmation when we, a, have the patent, we are already involved in clinical research to have an opportunity to invest in that area in the future as well.

To elaborate a bit, we were approached about 4 years ago by Professor -- Montpellier Hospital in France and Professor Choquet. Forgive my French pronunciation, I'm better in English and somewhat better in Italian. However, they approached us because they were working with ultrasound and nerve stimulation but found our technology as the missing link to produce a device that would successfully eliminate the very expensive and very dangerous morbidity associated with peripheral nerve blocks. So they are the world leaders in peripheral nerve blocks, and they approached us. We've been working with them for approximately 4 years in development and this is culminated in the patents, which we received. These are our patents at Milestone Scientific.

So you're correct. The market was correct. This is very, very important. It is a huge market. It is going to expand dramatically because we are moving away from the dangers and the high cost of both general anesthesia and conscious sedation. Wherever we can do regional anesthesia, that's where the world is moving. So the potential for this is enormous in this area. And we are certainly, according to the world experts, the missing link in this, and they have proven that. So yes, it's -- this and other things are very, very important to the future of our company.

So when your new sales force works with hospitals, they are not just working on epidural application. They're also addressing the PNB procedure potential for all hospitals? So I understand correctly.

No. Not yet. Right now we're putting all of our efforts into significantly expanding dental, and both -- and in Europe and the United States, the epidural market in labor and delivery. We will be moving into a new instrument that will do peripheral nerve block. That is one of the areas that we're moving into. As you know, Botox is one possibility intra-articular. But as Arjan said, wherever the syringe is used for subcutaneous injections, we can replace the hypodermic syringe. So those are the areas that we're looking to immediately: the PNB, the dental instrument, the Botox area while we expand the dental. Do you want to add anything to that?

And with that, this concludes our question-and-answer session. And I would like to turn the call back over to management for any closing remarks.

I'd like to thank everybody for joining the call. I'd like to say that we continue to work diligently in expanding the epidural market. And we are also working worldwide to expand the dental market as we have probably 3.5%, 4% of market share in the first world. So there is a great deal of room for expansion. We continue to bring down and hope to continue bringing down our burn rate, and we've been successful at that. The other issue that has added considerably to our balance sheet in the first quarter is the conversion of the warrants. We have, I believe, thus far, brought in $4.3 million, Joseph?

Yes.

About $4.3 million on the conversion of warrants. We had said when we did the last raise through Maxim that we had -- did that raise because we were very nervous as we should have been given the pandemic. We didn't know how long it would take to move out of that and the subsequent recession. It now looks like we're far more optimistic. But that one way which we had then to secure the success of the company over a long period of time has been dramatically expanded with this other money coming in. So we remain in very good financial position. We can see no reason operationally for raising any capital going forward. Obviously, if the stock was $10 or $20 a share, the Board might think differently. But for where we are right now, we have no operational needs for money going forward for well over the 12-month period that -- moving forward.

So thank you all for joining us. We very much appreciate it and hope to have additional reviews coming forth over this quarter.

Turn it back over to you, Devon.

And with that, this concludes today's teleconference. You may now disconnect your lines at this time. Thank you for your participation, and have a wonderful day.