Milestone Scientific Inc. (MLSS) Q1 2018 Earnings Report, Transcript and Summary

Good day, ladies and gentlemen. Welcome to the Milestone Scientific Inc. 2018 First Quarter Investor Conference Call. Today’s conference is being recorded. At this time, I would like to turn the conference over to Natalya Rudman. Please go ahead.

Thank you and good morning and thank you for joining Milestone Scientific first quarter 2018 financial results conference call. On the call with us today are Leonard Osser, Interim Chief Executive Officer and Joseph D'Agostino, Chief Financial Officer. The company issued a press release yesterday, Tuesday, May 15 containing first quarter 2018 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 first quarter ended March 31, 2018. Before we get started, we would like to remind everyone that during this conference call we may make forward-looking statements regarding timing and financial impact of Milestone’s ability to implement its business plan, expected revenues and future success. These statements involve a number of risks and uncertainties and are based on assumptions involving judgments with respect to 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 with the Securities and Exchange Commission, including without limitation Milestone’s report on Form 10-K for the year ended December 31, 2017 and Milestone’s report on Form 10-Q for the first quarter ended March 31, 2018. The forward-looking statements made during this call are based upon management’s reasonable belief as of today’s date, May 16, 2018. Milestone undertakes no obligation to revise or update publicly any forward-looking statements with any reason. With that, we will now turn the call over to Len Osser. Please go ahead, Len.

Thank you, Natalya and thanks to everyone for joining us today. Starting first with our CompuFlo Epidural system, we have begun to ramp up our commercial efforts with the recent hiring of two highly experienced sales and marketing executives. As discussed on the last call, we hired Sharon Smith as Executive Vice President of Global Sales & Marketing. In the short time since joining Milestone, she has performed excellently and is helping bring focus to our domestic and global commercial efforts for the Epidural Instrument. Since joining the team with strong experience in developing strategies, we have launched Sharon very quickly implement those strategies both in the USA and Europe. In addition, we recently hired Eric Gilbert as VP of U.S. sales. Eric brings extensive experience in medical instrument sales, including experience with feeding anesthesiologists and radiologists as well as orthopedic and neurosurgeons. With these key hires in place, we are now commencing the next phase of our strategy, which involves building out our distribution channels. Specifically, we are pursuing decentralized sales strategy, employing regional distributors with strong physician relationships within their respective territories and clinical specialties. Specifically, we are targeting distributors with highly specialized sales forces that have the ability to both educate and inform anesthesiologists on the clinical benefits of the CompuFlo Epidural system. Earlier this week, we announced that we signed an agreement with a Midwestern distributor that brings very strong relationships with key opinion leaders and anesthesia providers across markets in the Midwest. We are now in discussions with additional distributors and look forward to announcing similar agreements in the coming weeks and months. We also entered into distributor agreements in Europe and the Middle East for our CompuFlo Epidural system. Importantly, we are on track to have our clinical trials published in select industry journals later this year, which should help drive market adoption. At the end of the first quarter, we announced that Health Canada issued a medical device license to the Epidural system. This is another important step and validation in our global rollout strategy. Finally in April, we announced that the CompuFlo Epidural system is featured in an article entitled Pressure Sensing Technology for Epidurals in the March issue of OBG Management, a publication in the OB/GYN specialty addressing patient care and practice management. This coverage further illustrates the interest we are beginning to generate within the industry. We recently announced plans to launch our new cosmetic injection instrument with the delivery of Botox and Dysport. There is a large and growing global market for these injections with over 8.4 million injections annually in the United States alone. The new cosmetic injection instrument is designed to inject accurate doses with the precision of a stylus pen and uses the same comfort speed technology that has made our dental injections painless. Turning now to our dental business, we experienced a decline within our dental division in the first quarter 2018, which was anticipated. This was due to Henry Schein purchasing additional inventories in the fourth quarter of 2017 to avoid a price increase effective in the first quarter of 2018 as well as delayed revenue recognition on sales to Milestone China. Nevertheless, we anticipate our dental division will achieve continued growth and maintain solid margins in 2018. Last week, we announced that the Brookdale University Hospital and Medical Center in New York will now utilize the Wand Computer Assisted Anesthesia System for its advanced education program in pediatric dentistry. In addition, the Wand will be incorporated to regular use in the Department of Dental Medicine & Oral Maxillofacial Surgery. Brookdale University Hospital is one of the largest nonprofit voluntary teaching hospitals in Brooklyn and the pediatric dentistry program alone has over 7,000 patient visits each year. Importantly, the fact that Brookdale is now utilizing the Wand was featured in a related WCBS-TV New York news report that was shot onsite at Brookdale. For those of you that haven’t seen it yet, a link to the new report is available on our website. And I would encourage you to watch this broadcast. At this point, I would like to turn the call over to our COO, CFO Joseph D'Agostino to go over the financials in detail and I will be back at the conclusion of Joseph’s call. Please go ahead, Joseph.

Thank you, Leonard. Revenue for the three months ended March 31, 2018 was $1.8 million versus $3.7 million for the first quarter of 2017. The decrease in revenue was related to the non-revenue recognition of orders from China and the advanced purchases from Henry Schein in the fourth quarter of 2017 due to the planned price increase in 2018. Medical sales for the three months ended March 31, 2018 and ‘17 were 36,500 and zero respectively. The low sales numbers reflect our strategy to initially place the instruments with top KOLs at little to no upfront costs in order to see the market and to drive product awareness. Gross profit for the first quarter of 2018 was $1.2 million or 69% of revenue versus $2.3 million or 62% of revenue for the first quarter of 2017. The improvement in the gross profit percentage for the three months ended March 31, 2018 is due to the higher gross margin on non-China business. The China business has lower margins as they continue to capture the Chinese market. The operating loss for the three months ended March 31, 2018 was $2 million versus an operating loss of $526,000 for the same period last year. This increase is primarily attributive attributable to the reduction in net sales of $1.8 million and an increase in selling, general and administrative expenses of $311,000. Net loss for the three months ended March 31, 2018 was $1.9 million or $0.06 per share versus a net loss of $578,000 or $0.02 per share for the comparable period in 2017. Now, I would like to turn our attention to the liquidity and capital resources. At March 31, 2018, the company had cash and cash equivalents of $2.1 million, total current assets of approximately $11 million and working capital of $4 million. We believe that our cash on hand accounts receivable and revenues from the dental business will be sufficient to operate the ongoing business for the remainder of 2018. At this point, I would like to turn the call back over to Leonard.

Thank you, Joseph. We anticipate some continued lumpiness in the dental business quarter-to-quarter due to the timing of domestic and international promotions as well as the timing of orders from China. But overall, we anticipate our dental division will continue to generate steady growth and maintains solid margins. At the same time, we have maintained a solid balance sheet, including capital structure, which we believe will help drive shareholder value as we execute on our strategy in 2018. We also continue to advance our platform technology across other indications such as cosmetic and veterinary medicine as well as pediatric applications in patients with complex comorbidities. So to wrap up, we remain encouraged by the outlook for the business and look forward to announcing additional developments as they unfold. I would like to thank you for joining the call today. At this point, we would like to open the call to questions. Operator?

Thank you, sir. [Operator Instructions] And we will take our first question from James Terwilliger with Paulson Investment Company.

Hey, guys. Can you hear me?

Yes, we can. It’s a little difficult we are in Beijing at the moment, so it’s little bit difficult with communication, but go ahead.

So very quickly and I know there is things you can say on Henry Schein, but when you say a price increase, can you say was it a high single-digit, low double-digit, low single-digit, can you quantify that the price increase that went into effect in 2018 a little bit more?

Okay. This is Joseph. The answer is it was a low single-digit increase however with their volume purchases it needs a significant difference in their profitability obviously. So, they try to take advantage of that when price increases do come along.

No, thank you. Absolutely. So on the next question though is really what is your – and I know this is a tough one to answer, what is your visibility into the inventory levels at Henry Schein and again Henry Schein is an 800-pound gorilla, you guys are a little bit smaller than them, but are you comfortable with the inventory levels and how much visibility do you have on the product pull-through with Henry Schein?

It’s a very good question, James. We look at it on a consistent basis. We do two ways. First, we calculate our estimate of what their inventory is and we look at information that they supplied to which includes a daily sell-through in instruments as well as hand pieces. So, by looking at that, I can tell you that we believe that their inventory is well under control that they sold through, which is important not necessarily in their warehouse, but they sold through to end users significant amount of the inventory and they probably have about 1 month supply at this point. So, they did a good job and we continue to grow that business on a sell-through basis.

Okay, thank you. And I worked at Johnson & Johnson and worked with other small companies with large partners and sometimes the market and the investors misinterpret what is just an inventory turn versus extrapolating that into generalizations on the entire industry and it’s really if your patient and the work in your favor. As you guys move into the summer months, this is a different question, I am asking about seasonality, we are looking at healthcare and medical devices, lots of times, summer months especially in Europe, the seasonality declines, but in the dental business, because the kids are out of school lot of the pediatric procedures seasonality actually increases for the kids, do you see seasonality in your business on the dental side with Henry Schein?

So, the answer to that, this is Joseph again, the answer to that is it depends on the geographical area to our sell-through, for example, in the Southern states and in Texas, schools go back in August. So, our summary is really only 1 month. Number two is that their sell-in is on a pretty consistent basis as I mentioned I can see – I don’t see much seasonality in their business. There is 1 month, which is July, which usually is a little bit lower on selling, but consistently year-over-year, month-over-month I know and I can expect, we can expect what the answer is going to be as far as sell-through and we tried to make sure that they are in the equivalent position with their inventory, so we don’t miss an opportunity to sell-through that inventory.

Okay. And my last question again, thank you for taking this. Does all of the U.S. business run through Henry Schein or because I know you had – or can you get customers on your own or did you have some carve-out customers prior to your Henry Schein deal or does it all go through Henry Schein?

No, our model in the U.S. and in Canada is exclusive Henry Schein.

Okay, excellent. Thanks, guys. And as a shareholder, I am waiting as everybody else is for some of these new product opportunities to be more visible and thank you for taking my questions. Keep it up. Thank you.

Thank you very much, James. I think because of the recent hiring and our anticipated publication in the journal of our major study, I think that as we go forward we will be in charge with the investors much more frequently than in the past and have quite a bit to announce as to move forward. Thank you.

And we will take our next question from Keith Goodman with Maxim Group. Sir, we are unable to hear you. Please check your mute function.

Hi, guys. I am sorry about that. Just a quick question in reference to overall market opportunity and where you sort of see the company over the next year or two, obviously you have had an approval now in the Epidural for about a year, you have recently made some hirings, you are anticipating getting published in journals. Where does – where do you think that leaves us in the short-term and the long-term as far as I guess what’s the opportunity and without giving guidance unless you are comfortable doing so sort of where do you see the company in the years from now?

Well, as you know, the strategy for Milestone Scientific is to produce instruments with their related disposables to different areas of drug delivery. This is our model. Our model is not to replicate distribution throughout the world. Our core competencies and convention, patents, regulatory approval in reducing instruments to practice. So, as we develop more instruments what we are doing is we are proving the viability of the instruments themselves and we are proving to a certain level of distribution that’s not only with the product be sold, but it will be used and that’s reflected in the consumables. So, what we will be looking to do in the near future and for the future of the company is not necessarily setting up distribution throughout the world that we keep doing that until we have an arrangement, but the final outcome of a product like the Epidural or dental or the cosmetic instrument or Intra-Articular Instrument would be a licensing agreement with the major joint venture for an outright sale of the technology as it pertains to that particular area of medicine. So, we are looking for sales in the tens of millions and arrangements such as these not selling ones and twos, but unfortunately it’s changed over the last 40 years whereas when used to make a deal before you produced the instrument when you had FDA approval patents and there would be a right of first refusal from a major and they would pay for that upfront. Now, these large companies are risk adverse, so the small companies, the developing companies such as Milestone have to bring it through the process, including setting up distribution in showing sales. The good news is that the companies that are risk-averse up to that point then will either buy you or have an arrangement such as joint venture licensing and pay up dramatically for it. So, we are fortunately at the point with the dental, with the Intra-Articular and with the Epidural and soon to be with the cosmetic instrument, we were ready to do that and show that success. And I think that, that validation of that first arrangement is very, very important to the company, because with the broad platform of technology, we can produce numerous instruments with the related disposables.

Okay, great. Thanks. I appreciate it.

Keith, did that answer your question?

Yes, it did. Very much. Thank you.

Thanks.

Thank you. [Operator Instructions] And we have a question from John Corve.

Hi, Leonard. Can you hear me?

Who is in John?

John Corve, I have been shareholder for years and years and years.

Yes, John. Hi, how are you?

Hi, good. How are you? I am glad to hear that you are in Beijing I hope that your trip was fruitful. Let me comment, you just helped me with your previous comment on my thinking as a long-time shareholder, I have been a little baffled by the timing, by the stock price, by the seemingly endless delay in developments seemed to be right on the cusp of great success, which seems to be put off and put off and put off. It’s been my idea for a long time of what you just stated, it’s not just the sale, it’s the use of these disposables. That’s going to make milestone a big success. And I was particularly dismayed as I am sure you maybe that once you got FDA approval, the stock price has done nothing, but declined and I know that’s beyond your control, but that is not what I expected. Do you think realistically that we are now at this juncture that you have been looking for and that we will have stability in your current employees and no more abrupt quitting of the CEO that’s always disruptive when we get a resignation of a CEO and I think Milestone has had a couple of them since I have been a shareholder. So are we now at this juncture that I have been waiting for, for years and you have to?

Well, you have asked quite a number of questions. For one, your counting is right, it is in fact that couple as I have tried to retire or semi-retire twice and we have been unsuccessful with that. As far as employees go, Joseph who is sitting down with me. He has been with the company since 9 years. Joseph has been with us for 9 years mostly as CFO, but also as COO. Dr. Hoffman who has been with us for probably 18 years, we have employees most of our employees are with us over 5 years and 10 years. So, we have been very, very good with employees, but we have been absolutely dreadful who is replacing myself, as CEO. So, you are correct – you are certainly correct there. As far as where we are and what are events that will make a significant difference in the spot, I am certainly as surprised as you are that with the FDA being granted, it did not really move the stock at all and it’s been declining since as we have seen. We have organic volume. We saw that they recently had about 200,000 shares and 17,000 shares in looking at our noble list, which we get of shareholders we don’t see any movement with shareholders above 50,000 shares and we have quite a number of shareholders we have funds that have in fact increased our positions over the last year. So what I am looking for basically at the moment is what we are putting all of our efforts into at the moment, which is the Epidural. We are commercially since FDA approval on time for it as we have to manage capital, we wait to hire people when we have the information that the people can use as ammunition to bring on distributors. And we did not bring these people on until we felt that we were very close within 6 month period of having it published or come to study, which is a major study in drug delivery with the Epidural instrument in a major journal. So, we waited for that. So, there is certain things that if we were very well capitalized, which we are certainly not, we try not to dilute the shareholders and we raised very little then only when we really needed, because we try to balance this. So, a lot of things are delayed, because of that. We are delaying our work with the Intra-Articular and with the cosmetic instrument, because we are putting all of our efforts now actually into the Epidural instrument to bring that forth to make one of the arrangements that I mentioned earlier. So, I personally think as to the people I speak with and have greater expertise in I do as far as stocks go that when – that first deal was done to validate strategy that I mentioned earlier, that will be a major event for the company. I think that we will see certain markets do extraordinarily well going forward. We are here in China with our China subsidiary working with them. They are doing extraordinarily well as we see the handpiece sales here in China. They are trying to capture the market in this country and we are very fortunate to have someone here who ran $2 billion divisions of Sinopharm over 15 years. Sinopharm is the largest medical distribution company in China. So, we are trying to, on the one hand increase our disposable sales and STA sales in the dental business while at the same time building up the Epidural business to a position where we can have a strategic sale or joint venture or licensing agreement that I mentioned before. And I think those events will be the drivers of the stock going forward. Does that answer your question, John?

That says the lot of the questions. We do need that breakthrough of some kind and in the dental business, this trial that’s going on the pediatric hospital in New York, would that be a catalyst for more widespread use in dental school throughout the United States in the world. I mean, there has to be some kind of a breakthrough at the ground level to get dentists not just to buy the unit, but to actually use this on a widespread scale?

Yes, it’s really territory by territory. It’s very different, because markets are very different. In China, our distributor has 200 employees. They are in every province of China. They have all the key opinion leaders in the country. They have – as part of their marketing efforts they have institutions that do training throughout China, training on our products to major hospitals throughout the country. We will be visiting one tomorrow. I think they have 55 SDAs there, they use it exclusively. But one of the big advantages in China is the dentists and the groups charge for the injection and this is a very big motivator for the dentists to use it, to use the product. So, each time they use it, we sell the disposable. We also have a highly skilled, as I mentioned earlier, highly skilled executive running that program in China. We also have a country where the dentists are very interested in technology, particularly technology coming from the United States. This is not replicated all over the world. It’s not replicated in the United States. Here, they are happy to have technology. They are happy to be using the newest technology in anesthesia and dentistry, whereas in United States, many dentists say well I know how to do it so it is from the 1860s. No, it’s a different attitude regarding doing the best you can possibly do for your patience. It’s also a different attitude with technology. It’s also a different attitude with making money. In China, we now have over 470 million people in the middle class both the government and private industry is pushing very hard in the dental sector. This is becoming an enormous market in dentistry. We see facilities clinics all over China now. When we first came to China 20 years ago, 15 years ago, about 14% of the market was private is clinics. Now, it’s 54% of private clinics. You walk into a private clinic, I did the other day, I didn’t know them, I walked in, they have panoramic cameras, they have facility was as good as anyone in Switzerland and the United States and Germany. And I asked them why they were still using the syringe assuming they were and they said we don’t use the syringe, we use computer and they took me into each operatory and each operatory had an SDA, one of our products and they charge for this profit center. So, it’s very different in different parts of the world and we have to adjust ourselves and work in those markets that show the best opportunity and that’s one of the reasons we spend a lot of time in China working with our partner. But I feel that the main catalyst going forward will be when we have a breakthrough in the sale of one of our instruments in the sector in medical and if it’s done through undoubtedly through a company much bigger than ours, but it’s a household name, it will be even better. I think that’s the driver, because then people can look at what we sell that for and perhaps the analysts can go over another 20, 50, 100 different instruments of what will be the value that we have in that area whether it’s pulmonology, whether it’s peripheral nerve blocks, there are numerous areas where we can enormously benefit from delivering injection technologies.

Well, thank you Leonard. I always get renewed encouragement. Thank you for your persistence and thank you for refusing to retire. I feel very comfortable with you at the helm.

John, thank you. That means a lot to me. Thank you very much.

You are welcome.

And we will take a question from Alexander Scharf with Maxim Group.

Operator.

Yes sir.

Are there any more questions?

Yes. We have a question from Alexander Scharf with Maxim Group.

Hi, good morning. So, do you have an update on the Intra-Articular instrument, are you still planning to submit a 510(k) application during this quarter?

No. On the Intra-Articular Instruments, you go ahead?

Yes, the Intra-Articular, this is Joseph. We plan on completing our application on 510(k) for submission by the end of the second quarter.

Okay, thank you for that. And then have you given any guidance on the expected timeline for the cosmetic product?

We are at a point now where we have prototypes. We have completed the mechanical thoughts of the – we have completed the design and have functioning prototypes that we will – that we cannot use on people yet. We are at the point now, where we need – we haven’t announced it, so I can’t say, but a certain amount of capital under $1 million in order to finish off that project. So at this particular time, we are looking at finalizing the instrument doing clinical study not necessarily for regulatory approval, but for marketing in the first quarter of next year. I don’t believe that we will finalize prior to that, but I believe our model at this moment is to go first into the European Community, arrange all the marketing there, arrange the KOLs, put on distribution and moving forward that way, because it’s a much easier and less expensive pathway. We will do clinical study – as I said I don’t know – I don’t believe we need a clinical study for the approval, but we do need it for marketing and sales. So, we will have a limited study not like the one we have for the Epidural, because we don’t need a major study for that, but I believe as far sales goal of that product that will be in – that will be next year.

Great. Thanks for taking the questions.

You are welcome. Operator?

Yes, sir.

Any further questions?

We do not have any questions in the queue.

Okay. I would like to thank you all for joining us on the call. And as I said earlier, I believe our communication with the shareholder base in the Street will be far more frequent and far more significant over the coming months. Thank you very much. Good day.

And once again, ladies and gentlemen that does conclude today’s conference. I appreciate your participation today.