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Sintx Technologies, Inc. (SINT)

Q3 2015 Earnings Call· Thu, Nov 12, 2015

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Transcript

Operator

Operator

Good day, ladies and gentlemen, and welcome to the Third Quarter 2015 Amedica Corporation Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this conference is being recorded. I would like to introduce your host for today’s conference, Mr. Mike Houston, VP of Commercialization. Mike you may begin.

Mike Houston

Analyst

Thank you, Krystal. Good afternoon, and welcome to Amedica Corporation’s third quarter 2015 earnings conference call. On the call with me today are Dr. Sonny Bal, Chairman and Chief Executive Officer; and Ty Lombardi, Principal Accounting Officer. By now, everyone should have access to the earnings release for the period ended September 30, 2015 that went out this afternoon at approximately 4:00 p.m. Eastern Time. If you have not received the release, it’s available on the Amedica’s 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 may be 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. 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 Dr. Sonny Bal. Dr. Bal?

Sonny Bal

Analyst

Thanks, Mike, and good afternoon everyone. Welcome to our third quarter 2015 earnings results conference call. I will begin by giving an update of Amedica’s recent operational highlights and afterwards, Ty Lombardi will provide us details on the financial results for the quarter and then we’ll open up for questions. I’d like to begin today’s call by sharing how pleased I am with the progress we’ve made throughout the company from our financial and operational standpoint. Despite, what we’ve experienced in the market in the last two trading days, I was assure our listeners that there is nothing wrong with the company. We are in a strong financial position, we are compliant with all debt covenants and we’ve made substantial progress in our goals and we’re executing on our vision all of which Ty Lombardi and I will outline later on in this call as Ty will outline also. We’re able to reduce year-to-date operational cash burn levels by 38% from last year, while also reducing our debt principal balance. This is a significant positive impact from the restructuring we completed at the beginning of this year. Result for these actions are beginning to show and these vital to our continued success going forward. I strongly believe that we have turned the corner as a company as we continued toward an increasingly positive trajectory. I am very optimistic in our ability to increase market share for silicon nitride materials, launch new and exciting products, engage more surgeons and expand our research and development, while increasing value for our shareholders. We have made excellent progress in all levels of our business this past quarter with the release of new products and expansion into new geographic market, much of which I’ll touch on later. We recently finalized definitive agreements to raise up…

Ty Lombardi

Analyst

Thank you, Dr. Bal. I am pleased to discuss the financial results of the company during the third quarter 2015. Our total revenue for the quarter was 4.8 million, down 19% from the prior year period and was primarily driven by lower metal business. As to our product mix, our silicon nitrate products were responsible for 52% of our overall product revenue during the quarter compared to 47% of our overall product revenue in Q3 of 2014. Silicon nitrate sales decreased by 300,000 or 10% as compared to the same period in 2014. This decline is primarily attributable to the loss of the few surgeons during 2015 and consequences from our restructuring. This is partially offset by the addition of new surgeons as well as international and private label sales. Our non-silicon nitrate sales during the quarter declined by 27% year-over-year. This decline was due to a lack of sufficient diversity and in our customer base and is the level of activity declined among a few key surgeons greatly impacted our top line results for the quarter. Furthermore given the important role, our metals products are pulling additional silicon nitrate sales. We are working to diversify our metal user base as Dr. Bal mentioned. We’re also investing our metals portfolio in order to improve surging ease of use and bring it with other products used in the market today. Third quarter 2015 gross margins ended at 66% of total sales as compared to 68% during the prior year period. Although we have reduced our product cost, production efficiencies and lower overhead cost, the decline in gross margins relative to private label and international sales during the third quarter of 2015, which have lower gross margins due to lower selling price but higher operating contribution margins and sale commissions are paid…

Sonny Bal

Analyst

Thanks Ty. Operator will you now please instruct the callers on how to join the queue for questions.

Operator

Operator

Thank you. Our first question comes from Mike Matson from Needham & Company. Your line is open.

Mike Matson

Analyst

Hi, thanks for taking my questions. I guess I just wanted to know first of all what the balance sheet is going to end up looking like after the financing in completed. I guess just for timing on that, I mean is it done or is it still happening?

Ty Lombardi

Analyst

It is still occurring. The financing will come in two additional tranches, one which we expect here soon and then another one before the end of the year. At that point as like we indicated, we would expect our debt, principal balances to be approximately 17.5 million thereby reducing our debt significantly and our derivative liabilities to be - the majority of them to be gone by the end of the year.

Mike Matson

Analyst

And your share could, would you expect that to look alike?

Ty Lombardi

Analyst

It’s a little unclear right now. Currently we have approximately 79 million, we had on fully diluted at September 30th, we have approximately 45 million with warrants and that will depend on the price and the timing of that. But we’ll definitely increase in addition to the 79 million it’s currently outstanding right now.

Mike Matson

Analyst

Okay. Thanks. And then question for Dr. Bal. I was wondering, how does the tier date from CASCADE look, I mean - do the efficacy continue?

Sonny Bal

Analyst

Yeah, I mean no surprises there as you can imagine bone that healed at 12 months, say it healed at 24 months and beyond, so the FDA wanted 24 month data. And when we shared our 12 months data, the poor silicon nitrate not surprising heal as well as the patient’s own bone. This device is already in use in Europe, so none of this is too surprising. But the short answer to your question is, yeah the data looks about the same as the 12 month data.

Mike Matson

Analyst

Okay. And then just as far as the timing, I mean the press release said FDA says 90 days to your back to you, so I mean I would put a count like first quarter when you expect some sort of response, correct?

Sonny Bal

Analyst

Correct, that’s about right, that’s maybe sooner but that’s about when we expect the response. And we’ve taken the time to put in a strong application answering the all the questions they asked the first time around. So hopefully it’s just 90 days.

Mike Matson

Analyst

Okay. Alright, that’s all I have. Thank you.

Sonny Bal

Analyst

Thank you, Mike.

Ty Lombardi

Analyst

Thank you.

Operator

Operator

Thank you. Our next question comes from Jeffrey Cohen from Ladenburg Thalmann. Your line is open.

Jeffrey Cohen

Analyst

Hi gentlemen, how are you?

Ty Lombardi

Analyst

Good, how are you.

Jeffrey Cohen

Analyst

Just fine. So just a few questions around, if you could review with me the three partners thus far, one was Worthington in the dental indication, and could you just review with maybe other two?

Sonny Bal

Analyst

The other two, we signed a letter of intent in the summer, earlier we have not named that partner and we are working diligently with them to ensure that they have a clear regulatory pathway for silicon nitrate and the products that they will wish to do in OEM, have us manufacture their product in silicon nitrate. So we are hopeful, things are encouraging, we’ve had good news along that font over the last two months and we’re tending to work with them and hope to continue to move that forward to a definitive agreement here over the next period of time. And then we signed another private label partner that we announced last week. At this time, we haven’t named them as they from a competitive reasons decided not to be named at this point. So those are the ones that we have signed this year and we are looking to sign at least one more by the end of this year.

Jeffrey Cohen

Analyst

Okay and could you indicate or confirm the last two, are they specific to spine?

Sonny Bal

Analyst

Yeah, they are specific to spin.

Jeffrey Cohen

Analyst

Okay. Have you any feedbacks from here, any commentary that you could provide as far as the core silicon nitrate product that’s been launched in Europe as far as some of the feedback from physicians or feedback from images that have been taken?

Sonny Bal

Analyst

I mean the feedback we’re getting is in line with what I wouldn’t anticipate as a ceramic scientist and as a physician. Of course materials in general are osteo-conductive meaning the movement grows into them, so that’s not a surprise. This material has additional properties that particularly attract osteocytes or osteoblasts more informing cells. There is no negative news. There is no adverse reaction to it. It’s worked very well in Europe. The American FDA requires more and that’s why we have to submit the application here. But the reason this is particularly exciting is given the surface nano-chemistry of the material and its bioactivity. First, the mirror creation of a poor substrate like that is remarkable. No other ceramic can do it. Two, it goes beyond being osteo-conductive, representing a much larger surface area that’s bioactive to bone, to stem cells, to soft tissues, to the biological environment we put in. So I am very excited that this material will go well beyond its current application and the composite fusion device.

Jeffrey Cohen

Analyst

Okay, perfect, thank you. That’s it from me.

Sonny Bal

Analyst

Thanks, Jeff.

Operator

Operator

Thank you. And this concludes our question-and-answer session for today’s conference. I would now like to turn the conference back over to Sonny Bal for any closing remark.

Sonny Bal

Analyst

Thank you. And thanks to everyone who participated on the call. I would like to reiterate my excitement for this year and next and beyond. We truly believe the orthopedic market is that an inflection point given a 30 or 40 year history of biomaterials without much innovation at all and naturally it’s looking for innovation, which has been evidenced in our recent discussions with OEM partners, private label partners, distributors and every conference we’ve been to. This is an incredible opportunity for our company to prove the benefits of silicon nitrate which almost prove themselves and get wider adoption of the material. I am very optimistic and proud that our team can take advantage of this opportunity with our recently improved financial position. And I look forward to providing another update in the future. Thank you.

Operator

Operator

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