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Sintx Technologies, Inc. (SINT)

Q3 2014 Earnings Call· Thu, Nov 6, 2014

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the Third Quarter 2014 Amedica Corporation Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we’ll conduct a question-and-answer session and instructions will follow at that time. (Operator Instructions). As a reminder, this call is being recorded. I would now like to introduce your host for today's conference, Mr. Mike Houston, Director of Investor Relations. Mike, you may begin.

Mike Houston

Management

Thank you, Michelle. Good morning, and welcome to Amedica Corporation’s third quarter 2014 earnings conference call. On the call with me today are Dr. Sonny Bal, Chairman and Chief Executive Officer; and Gordon Esplin, Chief Accounting Officer. By now, everyone should have accessed to the earnings release for the period ending September 30, 2014 that went out this morning at approximately 9:00 A.M. Eastern Time. If you have not received the release, it’s available on the Amedica website at www.amedica.com. This call is being webcast, and a replay will be available on the Company’s website. I’d like to remind you that certain items that maybe discussed in today’s call are not based entirely on historical facts. These items should be considered forward-looking statements, and are subject to many risks, uncertainties and other factors that are difficult to predict and may affect our businesses and operations. As a result, our actual results may differ materially and adversely from those expressed or implied by our forward-looking statements. A discussion of some of these risks, uncertainties and other factors are set forth in our SEC filings. We undertake no obligation and do not intend to update any forward-looking statements, as a result of new information or future events or circumstances, arising after the date on which it was made. With that, I would now like to turn the call over to Sonny Bal. Dr. Bal?

Dr. Sonny Bal

Management

Thank you, Mike; and good morning, everyone. Welcome to Amedica's third quarter 2014 earnings conference call. I will provide you an overview of Amedica's third quarter business highlights and afterwards Chief Accounting Officer, Gordon Esplin will give you further details on the financial results for the third quarter and the nine months ending 2014. And after that, we will open the call up for your questions. I am very pleased to announce that the third quarter revenue for Amedica's proprietary silicon nitride ceramic products increased 57% over the prior year period to $2.8 million. For the nine months ending September 30, 2014, silicon nitride revenues increased by 50% over the same period last year to $8 million. Our total revenue for the third quarter 2014 was $6 million, which beats consensus estimates. Silicon nitride sales growth in the third quarter reflected continued strength of Valeo interbody spinal devices with good positive market acceptance of Amedica's second generation transforaminal lumbar device release which was announced in September. With our 20,000 implants sold to date, market acceptance of the Amedica's silicon nitride interbody devices, both the first and the second generations, remain strong. Since our last call, there have been several announcements, and we'll go over the people first. We added a Vice President of business development to help us develop the OEM and private label channels. We are very pleased with the traction and attention we've received, but thus far and as we continue to selectively invest in the organization to support our growth specifically in terms of the OEM and private label channels. We also appointed our newest Board member Eric Stookey, who brings extensive commercial expertise in orthopedic devices. Eric spent the majority of his carrier at Wright Medical Group where he was the President of the Extremities and…

Gordon Esplin

Management

Thank you Dr. Bal. I am pleased to discuss the financial performance of the Company during the quarter ended Q3, 2014. As Dr. Bal mentioned our total revenues for Q3 of 2014 was $6 million and for the nine months ended September 30, 2014 our total revenue was 17.6 million. As for product mix our silicon nitride ceramic products were responsible for 47% of our overall product revenue in Q3 of this year compared to 34% of our overall product revenue in Q3 of last year. The Company experienced a 50 basis point increase in gross margin percentage to 67.7% for the quarter as compared to the third quarter of last year, excluding the impact of provisions for excess of obsolete inventory our product costs as a percentage of product revenue decreased by about 4 points due to production efficiencies which Dr. Bal also spoke to. Research and development expense for Q3, 2014 increased by $1.3 million to $2 million when compared to Q3 of last year, primarily related to additional clinical studies expense and product development efforts to support the utility of our silicon nitride products and a $500,000 increase in non-cash stock based compensation expense during the third quarter of 2014. We believe that research and development expenses will continue to increase in 2014 as compared to last year as we implement additional clinical studies to support our growth in nitride products. General and administrative expenses were $2.9 million in Q3 of 2014 compared to 1.2 million in Q3 of last year. This is primarily due to increases in personnel related and insurance expense as well as $700,000 increase in non-cash stock compensation expense during the quarter. We expect to maintain current general and administrative expense levels through the balance of this year excluding non-cash stock comp expense.…

Sonny Bal

Management

Thanks Gordon. And we’ll open the call for question but before we do so I’d like to acknowledge the lasting impact our Former Chairman of the Board Dr. Max Link has had on Amedica and the healthcare industry. Dr. Link joined our Board in 2003 when we were still working towards developing our silicon nitride technology platform. We were saddened by the passing of our friend colleague, advisor and mentor to the Company for the past 11 years, and Dr. Link’s commitment to drive medical innovation that benefits patients around the world is greatly missed by everybody here at Amedica. So operator would you now please instruct the callers on how to join the queue for questions.

Operator

Operator

(Operator Instructions). Our first question comes from John Gillings of JMP Securities. Your line is open.

John Gillings - JMP Securities

Analyst

So first I just want to touch on the Spinal Kinetics deal. I know its early days; you don’t have any sales there yet. But can you give us just of ballpark idea of the potential there?

Sonny Bal

Management

You’re talking of the private label agreement?

John Gillings - JMP Securities

Analyst

Yes, the OEM agreement with Spinal Kinetics.

Sonny Bal

Management

We anticipate booking revenue from the private label agreement in the first quarter of next year. Now that agreement and others we hope to announce soon validates our technology platform and puts us in a strong position to accelerate the current discussions with any others. Now if you are talking OEM so that's the matter of -- that's more complex and that can take 12 months to 18 months to realize revenue. And once we sign those agreements, so that's hypothetical.

John Gillings - JMP Securities

Analyst

And then next I just wanted to hit on the secondary. So you ended the quarter with 10.4 million in cash and assuming that gets done for the full 15 million, how far does that take you and are there any specific milestones that you are trying to get through with that money?

Gordon Esplin

Management

John, we’re very confident in our financing strategy that we have in place to enable us to continue to maintain compliance with our minimum liquidity covenant and unfortunately due to SEC regulations we can't really comment on that offering. But we are confident in the things that we've got, the works and I hope to be able to make some announcements regarding those things in the coming days and weeks.

John Gillings - JMP Securities

Analyst

And then on the CSC products in today's cost conscious environment we're all obviously aware of how important it is to reduce cost. Can you give us just kind of a ballpark idea of the kind of savings that could be seen in a procedure from using that versus the standard today with some kind of biologic?

Sonny Bal

Management

John this is Sonny, we are working on the pricing strategy, I can tell you that that's a great question. Begin a surgeon myself, the cost pressures are all around us and hospitals are very conscious. Five, 10 years ago it was no big deal to bring in your drinking buddies everybody who has bone filler and putties just squirt it into a spine or a hip or a knee and do hell with the cost, that's not true going forward. To me as a surgeon I am very excited that we have a synthetic material that will grow into bone as well as your bone autographed without the need for thousands of dollars worth of whatever you want to put in. So while we don't have the exact numbers, I think that's a huge direct advantage of our material in a cost conscious environment.

John Gillings - JMP Securities

Analyst

And then just one last one. It sounds like you guys are continuing to bring a lot of new surgeons in which is great. I just wanted to take a look at the other side of the equation. And can you give us a sense of how things are going in terms of the penetration of your existing surgeons. Once somebody comes in and sort of uses the product maybe you can give us a feel for how many of your surgeons is sort of a natural run rate and natural penetration level for their practice versus the guys that are still sort of needing to ramp up and that will be it from us?

Sonny Bal

Management

When I became CEO I have a numbers of emails I can forward to you from surgeons that are very excited about the material and this team. And talking to surgeons and looking at our publications received, the penetration and adoption and retention of surgeons is given, and I am very confident about that. And the reason for that goes back to the inherent advantages of the biomaterial. At the end of the day, surgeons are excited about what they do, they are aggressive and they will use the product that works. I mean that's the first line. The second line of interest in a product is if the company is responsive, is willing to execute something as dynamic as design and build and we got that covered. So you've got material that a surgeon can design and fashion into something that like I am very confident about penetration, adoption and retention.

Operator

Operator

Our next question comes from the Mike Matson of Needham & Company. Your line is open. Mike Matson - Needham & Company: I guess first question for Gordon. How much cash did you use during the third quarter? I mean I guess you ended the last quarter with 11.6 million and you ended this quarter with 10.4 million, that's a 1.2 million change. But I didn't know if you had any cash coming in from any of the financing that you had on the previous financing?

Gordon Esplin

Management

Yes, we did. We completed the remaining funding from the Magna notes in Q3 and we used about $3 million in operations in the quarter, in third quarters with them. Mike Matson - Needham & Company: And then I guess just with regards to the private label and OEM agreements, can you just describe in general terms the economics of those? I mean I would assume their lower gross margin but then you have lot less SG&A as well so the operating margins might be similar to or better than some of the other direct sales?

Gordon Esplin

Management

That is a great question. That is very important to us because of the cost associated with that business models are lot lower, we don't have as Sonny mentioned, capital intensive CapEx costs for instrumentation sets we also have much lower internal price development and selling and marketing costs. So each of those dollars are very much more accretive to the company and while we can't come out on specifics as far as deals and specifically Spinal Kinetics we’re very excited about opportunities and the attraction we are gaining with those announcements coming out now, and it's also related to the economies of scale obviously getting more product out the door. Mike Matson - Needham & Company: But the gross margins I mean -- I got to believe the gross margins would have to be lower on those, I mean…

Gordon Esplin

Management

Yes they are in absolute terms. Mike Matson - Needham & Company: And then I guess some clinical questions for Sonny, the antimicrobial properties to me seem like one of the bigger benefits of silicon nitride. So are there any plans, I know there has been some laboratory work that’s been done but are there any plans to do any human studies? I don’t know if you could maybe the power you’d have to have such a huge study just wouldn’t be feasible. But just wondering if you’re going to do any work there, I guess either more laboratory or human work.

Sonny Bal

Management

I feel like I am talking to a fellow surgeon, because that’s a great question and it touches on all the good points. The power of the study would be very difficult in human terms. When you’re looking at the incidence of inspection being so small to begin with, you’re absolutely right, to do a randomized trial would be impossible. That said much of what we do in orthopedic surgery today doesn’t really have double blinded clinical data, it has common sense behind it and I can go on and on -- flowing operating room, so there’s never been a study showing that it makes any difference. The use of surgical masks never been shown to make difference in infections we still use them, and we go on and on. But more importantly when you make, what might be an outrageous claim to your advantage saying something as antimicrobial, you hit the name on the head, you need validation of that because the next question surgeon is going to ask is why is your material antibacterial? What other evidence do you have? And in many things in clinical medicine if you have enough supportive evidence built around that material to validate your claims it’s going to get accepted. So to that end the abstract that talked about at the ICJR meeting that got the award for excellence, we looked at the sub-micron characteristics of the surface. And it turns out there are chemical alterations that are very, very molecular at levels that are going on the surface that make this material antibacterial and osteogenic. So that’s the hypothesis we’re going forward. We’ll support it with additional clinical data, additional investigated study, maybe some animal data but we’re going to keep on pursuing this so we have a portfolio of papers that answers the question of why is your material antibacterial. In terms of cost and advantages to patients, that’s huge. No one wants an infection, there is a lot of cost lot of morbidity associated with infections and it’s a big focus of hospitals the government payers, doctors who try to bring that incidence as close as possible to zero. Mike Matson - Needham & Company: And then just with regards to CASCADE, I mean you’re using that study to support your -- I guess it’s a 510 (k) for that space or product. And just wondering, you’re sure that the FDA is going to be okay with the fact that the study was run only in Europe, right. Because I guess seems like the FDA generally wants studies done in the U.S. I know it’s not an ID so maybe that makes the bar sort of lower.

Sonny Bal

Management

When it comes to the FDA your guess is as good anybody else’s but more confident the study was done based on established protocols, I’ve talked to the CRO to the biostatisticians, we seem to have crossed every eye and beyond. It’s a very well structured study, it’s blinded we don’t have anything to do with the interpretation of that data. So that’s good news. And the people that we have hired is consultants as people to support this study are very familiar with how to get things through the FDA. So I am reasonably confident. I don’t think Europeans fuse or heal their bone any differently from us, so the clinical data are very much translatable to this side of the Atlantics. Mike Matson - Needham & Company: And then the SNAP and JAX trials, I mean this is the first I recall hearing about those. So I mean are these something that had been planned in the past or these trials are new since you came aboard?

Sonny Bal

Management

So they were planned, they were planned and we’ve also got some retrospective data from another surgeon but we can talk about that offline. That JAX study for example, was planned and it got a little delayed because we expanded indications to include allograft bone which is used by surgeons, so it’s clinically relevant to include that and also expanded the scope of the study to a multi-level fusion which is a real clinical situation. And finally we’ve got multiple surgeons in multiple sites. So there were planned and just like they were planned and they’ll be executed starting next year we have more studies planned next year that we’ll execute in the future. Mike Matson - Needham & Company: And then with regards to sales people and distributors, I mean any changes from last quarter in terms of numbers there?

Sonny Bal

Management

No we have a stable sales and distributor network now that we’re happy with and that’s helping us execute a strategy. So we’re happy and as I mentioned before what’s important for me to do is spend some face time, some one-on-one with our sales and distributor staff because being an orthopedic surgeon I know how absolutely critical they are to our success.

Operator

Operator

I am showing no further questions. I’d like to turn the call back over to Dr. Bal for any further remarks.

Sonny Bal

Management

Well that concludes our third quarter earnings call. We have a number of catalysts of growth going forward that I just want to remind everyone out. CASCADE clinical trial we talked about, we’re working on additional OEM, private label agreements which we hope to announce, the 510 (k) submission and clearance for our composite silicon nitrite interbody. The clinical trials you heard about that I am so excited about and more that we will launch our meeting with the FDA to discuss the regulatory path for a solid hip and knee products. And of course you've seen the continued high growth of silicon nitride and market acceptance through our existing sales channel. I am very confident that we are going to see significant progress and excitement by the first half of 2015. So we want to thank you everybody who participated in this call, we look forward to speaking with you again in March. Thank you very much.

Operator

Operator

Ladies and gentlemen, thank you for participating in today's conference. This does concludes the program and you may all disconnect. Everyone have a great day.