Milestone Scientific Inc.
Q1 2017 Earnings Call Transcript

Published: 16 May 2017

[Operator:]

Good day, ladies and gentlemen. And welcome to the Milestone Scientific Incorporated First Quarter 2017 Investor Conference Call. Please note, today’s conference is being recorded. At this time, I would like to turn the conference over to Mr. David Waldman, please go ahead sir.

[David Waldman:]

Good morning and thank you for joining Milestone Scientific’s first quarter 2017 financial results conference call. On the call with us today are Leslie Bernhard, Chairman of the Board, and Joseph D'Agostino, Chief Financial Officer. Unfortunately Leonard is not available because he is travelling overseas and is unable to participate on the call. However we've asked Leslie to present the business overview and closing remarks for Milestone Scientific today. The company issued a press release yesterday, Monday, May 15, containing first quarter 2017 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 212-671-1021. The company’s management will now provide prepared remarks, reviewing the financial and operational results for the first quarter ended March 31, 2017. Before we get started, we’d like to remind everyone that during this conference call we may make forward-looking statements regarding timing and financial impact of Milestone’s ability to implement its business plan, expected revenues, and future success. These statements involve a number of risks and uncertainties and are based upon 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-K for the year ended December 31, 2016 and Milestone’s report on Form 10-Q for the first quarter ended March 31, 2017. The forward-looking statements made during this call are based upon management’s reasonable belief as of today’s date, May 16, 2017. Milestone undertakes no obligation to revise or update publicly any forward-looking statements for any reason. With that, we’ll now turn the call over to Leslie Bernhard, Chairman of the Board. Please go ahead, Leslie.

[Leslie Bernhard:]

Thank you, David and thanks to everyone for joining us today. I’m pleased to report that we achieved a 53% increase in domestic handpiece sales in our dental business, as Henry Schein our exclusive distributor for the US and Canada completed its product and sales force training in the first quarter and the exclusive product sales team has now begun rolling out our products nationwide. The increase in handpiece sales was partially offset by a decline in domestic instrument sales due to the timing of advance orders by our distributor late last year. We continue to see an increase in Europe and South America, which we anticipate will continue throughout the remainder of the year. We expect sales of both handpieces and instruments to continue to increase for the balance of 2017 as Henry Schein continues to ramp up. We continue to see increase in global demand and expect international sales to further accelerate in the second quarter and balance of the year. Importantly, our dental division continues to generate positive cash flow on a standalone basis. We are also cultivating relationships with key opinion leaders. Recently we hosted the webcast with Dr. Sven-Marcus Beschnidt, one of Germany's top medical professionals of dentistry where he discuss the advantages and benefits of the want [ph] dental instrument, in delivering unparallel patient satisfaction and superior clinical and business practice outcomes. This presentation is on our website and we encourage those of you that may not have seen it yet to visit the site and listen to what Dr. Beschnidt had to say about the product. Turning to our medical instruments. We have successfully completed the clinical trials for our epidural instrument in the United States and have submitted our 510-K application for marketing clearance with the FDA. In advance of FDA market clearance, we are focusing on developing a key opinion leader network. This is essential to advance our full commercial rollout of our epidural instrument to the global marketplace. As part of our Middle East product launch strategy, we recently received regulatory marketing clearance to sell our epidural instrument and disposable kit in Saudi Arabia. We were also continuing our collaboration with medical practitioners in Europe and the Middle East and North Africa, including the clinical rollout of our epidermal instrument in the MENA regions, by initiating clinical evaluations at five hospitals in the United Arab Emirates and in Lebanon. In fact a number of key opinion leaders in the Middle East and North Africa regions have expressed further interest in broadening the techniques, scope into challenging thoracic epidural procedures, as well as extending its use into pediatric cases and complex co-morbidities. We also announced that we have received the marketing clearance to sell our epidural and intra-articular instruments and disposables in Australia. At this point, I'd like to turn the call over to our CFO, Joseph D'Agostino to go over the numbers in detail. But I will be back at the conclusion of Joseph’s discussion. Please go ahead Joseph.

[Joseph D'Agostino:]

Thank you, Leslie. Revenue for the three months ended March 31, 2017 was $3.7 million versus $3.6 million for the first quarter of 2016. The increase in total revenue by approximately $100, 000 or 3% was primarily related to an increase in instrument and handpiece sales to China. In the domestic market, total revenue increased by approximately $31,000 during 2017 over 2016. As Henry Schein completed its sales force training. We believe that the agreement with Henry Schein will lead to increased domestic sales of the STA instrument and handpiece in 2017. On the international front, total revenue increased by approximately $89,000. Gross profit for the first quarter of 2017 was $2.3 million or 62% of revenue versus $2.2 million or 62% of revenue in the first quarter of 2016. Operating loss for the three months ended September 30, 2016 was $526,000 versus an operating loss of $943,000 for the same period last year. The decrease is primarily attributable to completion of the clinical studies and other operating expenses related to Milestone Scientific’s medical division, the epidural and intra-articular instruments in 2016. Net loss for the three months ended March 31, 2017 was $505,000 or a loss of $0.02 per share versus a net loss of $750,000 or a loss of $0.03 per share for the comparable period in 2016. Now I like to turn our attention to liquidity and capital resources. At March 31, 2017 the company had cash and cash equivalents of $2.9 million, total current assets of approximately $11.3 million and working capital of $7.7 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 at least the next 12 months. At this point, I'd like to turn the call back to Leslie.

[Leslie Bernhard:]

Thanks, Joseph. So having completed the clinical trials of our epidural instrument in the United States, we're focusing our efforts on building relationships with KOLs, in advance of that FDA marketing clearance worldwide. Specifically, we have recently cultivated a new relationship with key opinion leaders in Europe, Asia and the Middle East and North Africa regions who've been supportive and recognize the advantages of our technology. We also continue to advance our platform technology across other indications, such as cosmetic, ophthalmic and veterinarian instruments, as well as pediatric applications and patients with complex co-morbidities. Our balance sheet remains solid and we continue to generate positive cash flow in our dental division. With the completion of our clinical trials for the epidural instrument and submission of our 510-K application for FDA marketing clearance, the burn rate of our medical subsidiary will be further reduced. So to wrap up, we remain encouraged by the outlook for the business. Look forward to announcing additional developments as they unfold. I'd like to thank you for joining the call today. And at this point we'd like to open the call for questions.

[Operator:]

Thank you, Leslie. [Operator Instructions] Our first question will come from Lucas Lee with Maxim Group.

[Lucas Lee:]

Hi, guys. Thank you for taking my question. Can you hear me well?

[Leslie Bernhard:]

Yes.

[Joseph D'Agostino:]

Yes, we can.

[Lucas Lee:]

Okay, good. So from the 10-Q that you guys filed last night, it states that you've briefed the FDA clearance for epidural might occur by the end of the second quarter 2017. Do you think you could provide a little more color on this? Thank you.

[Leslie Bernhard:]

Joseph, maybe you could talk a bit about the back and forth and where we are.

[Joseph D'Agostino:]

Sure, I could do that. As you know Lucas, we've prepared the information and supplied information both on the 510-K and questions that followed on the specific application on the epidural instrument to the FDA. We're hopeful at this point that the clearance will occur in the second quarter of 2017. But again, we have very little control over the FDA the process and their completion time. But so far we've been pretty encouraged by feedback information that we have received from the FDA.

[Lucas Lee:]

Okay, thanks. It's only like two weeks less until than the second quarter is over.

[Joseph D'Agostino:]

Yeah.

[Lucas Lee:]

Yeah. If I could ask you one more question...

[Joseph D'Agostino:]

The quarter is over June 30th, right.

[Lucas Lee:]

Oh, sorry.

[Joseph D'Agostino:]

Just want to make sure, or otherwise we won’t count on...

[Lucas Lee:]

Yeah, okay. I was kind of concerned, I am sorry.

[Joseph D'Agostino:]

Okay.

[Lucas Lee:]

In fact – yeah, okay. If I could ask you one more, during the last conference call you mentioned that you would be resubmitting the application for the intra-articular instrument. Do you have any update on this or any expected timeline? Thank you.

[Leslie Bernhard:]

Go ahead, Joseph.

[Joseph D'Agostino:]

Okay, sure. On the intra-articular, we have provided responses to the FDA and we are waiting for a response from them before we apply with the final application. So we're in a queue sub process right now, responding to their letter from December and identifying that we are ready to move forward with an IA application once we get responses from the FDA. So everything is moving in a positive direction and we hope to have confirmation back from them in a short period of time.

[Lucas Lee:]

Thank you. That was really helpful.

[Joseph D'Agostino:]

You’re welcome.

[Operator:]

Thank you, Lucas. Our next question will come from James Terwilliger with Paulson Investment.

[James Terwilliger:]

Hi, guys. Can you hear me?

[Leslie Bernhard:]

Yes.

[Joseph D'Agostino:]

We can.

[James Terwilliger:]

Okay. Thank you for taking my question. First Joseph, I guess this is for you, just real quickly the gross margins I thought would have tweet up a little bit with handpiece sales in the US, help me a little bit on the gross margins, unless maybe we cut price a little bit because we're going through Henry Schein the distributor. Is there any additional comments on gross margins?

[Joseph D'Agostino:]

Sure. The gross margin is a combination of a couple of factors. First of all, you're right, the handpiece business generally is the highest profitable business. However, as you have probably noted from our past discussions, we have been trying to develop our market in China at a faster rate than we have been in the past. And as a result, we have reduced our margins on the instruments and on the handpiece in that specific large market to increase marketing efforts and to increase the sales potential in the China market. On the US side, yes, Henry Schein is an expensive opportunity for us and I say opportunity because I believe that their growth over the next several years will more than offset the reduced GP gross profit that we're earning on that business. But it's a necessary and important opportunity for us to jump back into the big world with the largest distributor of dental medical and veterinary supplies in the world. I hope that answers your question.

[James Terwilliger:]

No, it does. Thank you. And thanks for reminding me about the price differential in China and what you're trying to do there and I like the terminology expensive opportunity. The other question on the on the balance sheet is really just the accounts receivable had a little bit of a spike and again I'm looking from the December number to the March number any comment on the increase in the AR?

[Joseph D'Agostino:]

The increase in the AR as of March 31 included as you can see receivables from our China venture which was in fact received in April, so that it looks like it's higher than normal, but effectively we're back into the right realm of business with them, our receivable are collectible and they look to be in good shape overall.

[James Terwilliger:]

Okay. And the last question I have, I've actually got two, I apologize. The handpiece number was tremendous. How should I think about this? The instruments did you have a large inventory stocking in order to a degree towards the second half of last year and so your distributor is still has that product and then they made a large order on the handpieces early this year, is that how I should think about that what the handpiece is up so strong and the releases - the instruments are down slightly?

[Joseph D'Agostino:]

That's a very good point. And let me just spend a minute and I'll answer each part of it. On the insurance business. Number one, with the people from Henry Schein they did buy in last year, but they are also buying in on a daily basis. We get orders - purchase orders continuously from them from all of their individual warehouses. So in Q1 we did have growth sales in our instrument business. But at the same time it was not a significant buying. So that is the reason for the reduction in revenue in Q1 and the issue with the STA business for Henry Schein. But important to note, that we get we get Pos, purchase orders every day from every one of their nine different distribution centers for four here 12 there. So it's moving forward. So it does cause a little aberration in the flow of revenue compared quarter-to-quarter. On the handpiece business...

[James Terwilliger:]

Thank you. Go ahead.

[Joseph D'Agostino:]

On the handpiece business, they're looking at and they have finally gotten back into providing the right inventory for them to meet their needs for our CompuDent, our legacy instrument which is still a very strong product even though we do not distribute any longer. Our CompuDent instrument there were still a lot of individuals out there, dental practitioners that use the legacy instrument and as a result Henry Schein has finally gotten to a point where they're able to bring that business back to us. So we will consider that to be a positive view and consider that to be a growth potential for us of the US in the next year.

[James Terwilliger:]

Okay. Thank. That’s was excellent. And then lastly just on the regulatory perspective, because I'm a big believer in what I think you have in your pipeline, as of today you have answered - you have submitted your 510-K and you have answered any additional questions, the regulatory agency has come back to you with, so to a degree the ball is 100% in the FDAs court?

[Joseph D'Agostino:]

Correct a 100% and I believe that that's why we are looking positively for this second quarter for the result of clearance or other information. But again, we cannot control it. It's up to the FDA, their timing. Hopefully we now have a new FDA secretary, so maybe we can move this process along.

[James Terwilliger:]

No, it's not just you guys, it’s all the companies I'm talking to. I'll jump back queue. But, thank you Joseph for taking the questions and thank you, Leslie for hosting the call. Take care.

[Leslie Bernhard:]

Thank you.

[Joseph D'Agostino:]

You’re welcome.

[Operator:]

[Operator Instructions] We’ll take a follow up from Lucas Lee.

[Lucas Lee:]

Hi. Just one more question on Henry Schein. So according to the 10-K it seems like Henry Schein is 25 exclusive sale specialists, are fully trained in selling the instruments on the field right now. And in addition to that is that, that the agreement will lead to increased domestic sales in 2017. Do you think you could provide us with some additional color on potential upside to this statement? Thank you.

[Joseph D'Agostino:]

Sure. Lucas, as we've identified before, but maybe Leslie wants to step in. Leslie?

[Leslie Bernhard:]

Well, in talking about the future of the Henry Schein relationship. Joseph, I think you'd bring a lot more color to it than I would. We are quite confident that we're with the right partner. We love everything we've seen so far. But maybe you could be a little more specific.

[Joseph D'Agostino:]

I do. So Lucas, when we look at Henry Schein, we have the 25 special individuals who've been trained, they are expert group. That group has been working with the one thousand field service individuals, so the exclusive group is really working through their internal group of sales –field sales people to help move their instruments under the exclusive products division into the field. So we believe that they are moving forward, that they are out making calls, knocking on doors with the field service people and also following up the leads that we generate through either our conference calls or through our shows that we attend or through calling from people that had interest from our articles that we provide through periodicals. So we believe with the sales force which really gives us a full spectrum of opportunity in the dental field that we'll be able to excite, get interest and finally to close the revenue cycle for the instruments. And you know, as well as I do, once the instruments are placed the doctors order the handpieces as an annuity and it continues on. So we're looking forward to that. At this point, the 25 people that are out there are actually reduced by about seven people recently for people that either were promoted or left the group and they are being replaced as I speak, and they'll be trained in the next two to three weeks. So we'll be back toward 25 individual complement. Did that answer your question?

[Lucas Lee:]

Yes. That was very helpful. Thank you for the color.

[Joseph D'Agostino:]

Not a problem.

[Operator:]

Thank you. And at this time we have no further questions in our queue. I'll turn the conference back over to our speakers for any additional or closing remarks.

[Leslie Bernhard:]

I'd just like to thank everyone for being with us today and we look forward to talking to you next corner with some more good news, including hopefully an FDA approval. Thank you.

[Operator:]

Thank you. And again ladies and gentlemen, that does conclude our conference for today. We thank you for your participation.