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Sintx Technologies, Inc. (SINT)

Q2 2015 Earnings Call· Thu, Aug 13, 2015

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Transcript

Operator

Operator

Good day, ladies and gentlemen and welcome to the Second 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 and Communications. Mike you may begin.

Mike Houston

Analyst

Thank you, Andrew. Good afternoon, and welcome to Amedica Corporation’s second 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 June 30, 2015 that went out this afternoon at approximately 4:00 PM 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 as well. 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 Dr. Sonny Bal. Dr. Bal?

Sonny Bal

Analyst

Thanks, Mike, and good afternoon everyone. Welcome to our earnings conference call. I will begin by providing an overview of the Amedica’s second quarter business highlights and afterwards Ty Lombardi will give us details on the financial results for the quarter and then we will take questions. I’d like to begin today’s call sharing how pleased I am with the progress we made across Amedica year-to-date both financially and operationally as Ty will outline later in the call. We were able to reduce year-to-date operational cash burn levels by 37% from last year. So, a positive impact of the restructuring actions that we took at the beginning of the year now starting to show and those are paramount to our continued success through the balance of this year. I remain very confident in our ability and my personal resolve to unlock the intrinsic value that this company holds and specifically that our material silicon nitride holds. Not only have things improved dramatically on the financial side, but we have had enormous success in our operations, and manufacturing and research and development and business development efforts. As I’ve been out on the road, in the US and across the world, speaking with investors, banks, surgeons, distributors and additional business partners this past quarter, I am reminded that our silicon nitride material is extremely unique and differentiated. There really isn’t anything else out there from a biomaterial standpoint that quite compares. I am also very pleased with the attention we have received this year with potential private-label and OEM partners as we continue to selectively invest in the organization to support our growth. We’ve continued those feasibility studies that I mentioned last quarter and we are closer to finalizing agreements with other private-label and OEM partnerships and that we hope to announce…

Ty Lombardi

Analyst

Thank you, Dr. Bal. I am pleased to discuss the financial results of the company during the second quarter 2015. Our total revenue for the quarter was $4.8 million down 18% from the prior year period and primarily driven by lower metals business. As for product mix, our silicon nitride products were responsible for 49% of our overall product revenue during the quarter compared to 46% of our overall product revenue in Q2 of 2014. Silicon nitride sales decreased by $0.3 million or 13% as compared to the same period in 2014. This decline was primarily attributable to the loss of a few key surgeons in the quarter which is partially offset by increased recruiting efforts of our sales organization. These efforts have resulted in new surgeons using silicon nitride products which we expect to outweigh the year-to-date declines in revenue in the second half of 2015. Our non-silicon nitride sales during the quarter declined by 22% year-over-year. This decline was due to a lack of sufficient diversity in our customer base and as the level of activity declined among a few key surgeons that greatly impacted our top-line results for the quarter. Furthermore, given the important role our metals product is [playing pulling] [ph] to additional silicon nitride sales, we are working to diversify our metals user base while also investing in our metals portfolio in order to improve surgeon ease of use and bring it on par with other products used in the market today. Second quarter 2015 gross margins ended at 71% of total sales as compared to 73% during the prior year period. Although we have reduced our product cost to production efficiencies and lower overhead costs, the decline in gross margins was due to private-label sales during the second quarter of 2015, which had lower…

Sonny Bal

Analyst

Thanks, Ty, and operator would you please instruct the callers on how to join the queue for questions?

Operator

Operator

Sure. [Operator Instructions] Our first question comes from the line of Mike Matson from Needham & Company. Your line is open.

Mike Matson

Analyst

Hi, thanks for taking my question. I guess, I want to start with the news about the composite implant with the FDA wanting to see the tier data, do you have any reason to believe or I guess, first of all, you haven’t seen anything beyond the one-year data. Have you?

Sonny Bal

Analyst

Yes, we have two year data that’s should be completed very soon but we have that data. It just wasn’t in the format that we could supply to the FDA, and there may be a few straggling patients that we have to complete, but we have seen that data.

Mike Matson

Analyst

Okay, so, I mean, do you have any reason to believe that it’s not going to meet non-inferiority and because if it doesn’t meet non-inferiority that the FDA is going to [stall though] the product?

Sonny Bal

Analyst

No, no, no reason to worry at all. I mean, this is my perspective as an orthopedic surgeon, when bone fuses or heals at six to eight weeks it doesn’t change in the next six years or sixteen years or whatever, unless there is some adverse effect. Specifically to this point, the 12 year data showed clinical benefits and showed in clinical bone in growth which for the first time without the use of any grafting material shows the result as good as autograft. So that was the excitement of the 12 month data. There is no reason why the 24 month data would be any less than that or frankly even more than that, it should remain static, once bone heals and fuses, maybe the clinical scores may go slightly up and down and in an insignificant way, but the data won’t be any different. And so there is no reason to suspect the FDA will not approve us.

Mike Matson

Analyst

Okay, all right. And then, I guess, just a few more financially oriented questions, so, just starting with the potential for delisting, what’s the timing, the deadline there to get the stock above $1 and are you considering anything like a reverse split or anything to try to avoid getting de-listed? A – Ty Lombardi: We would anticipate to receive the notice from the NASDAQ here in the next week or two and from there, we would expect to able to meet the provisions to have another six months extension and our goal and plan is to continue to drive on the strategy that we began implementing in the beginning of this year that is starting to come around and we are trying to take a turn for the better as a company and we believe there is upside and significant upside in the upcoming months. And so our goal is to continue to drive the strategy to increase the value of the company in the investors mind and strive to increase that value and hope that our stock goes in excess of the $1 prior to the middle of January.

Mike Matson

Analyst

Okay, and then, I guess, a couple of lenders are claiming that you are in default, I was wondering what’s the impact of that is, and how that can be resolved? A – Ty Lombardi: Yes, so there, we have a couple of notices with regard to default, we are addressing those, in the process of addressing those and getting those resolved and we are hoping in the coming months that we [indiscernible] have more insight with regards to that. No we don’t believe that the default [indiscernible] and we don’t see that there is any issues related to the default notices.

Mike Matson

Analyst

Okay, and then, the share count, I mean, what, I thought you said 65.8 million versus the 54.3 for this quarter I think it was, so, what should putting in my model going forward from here? A – Ty Lombardi: Yes, no our stock count is 65.8 million at June 30 and as a big part of that increase during Q2 is related to the secondary offering warrants that we did last November which increased the share count. As I indicated, we are now down to 140,000 of those warrants and so we are not expecting a significant impact in share count increase related to warrants. So, I think that 65.8 million is a good number.

Mike Matson

Analyst

All right, I mean, I was just looking at your financial – at your income statement, and looks like you are showing 54.3, so what’s the source of that difference? A – Ty Lombardi: Sorry, I am not – [indiscernible] on the balance sheet, we have 65.8 million. On the income, that’s on a weighted average based off, when the shares were issued and so forth and so, with the quarter I would, beginning the quarter at 65.8 that would be a better number to view for quarter three.

Mike Matson

Analyst

All right. That makes sense. All right, and then can you tell us anything additional about the OEM agreement that you announced during the quarter, letter of intent? A – Sonny Bal: Not much beyond what we talk about. It’s a party we are working on. There is some regulatory issues and the preferences that we discussed and disclosed further details on some of those issues have been talked about.

Ty Lombardi

Analyst

I guess, I would add to that, obviously they are [indiscernible] issues, but they want to make sure the regulatory path is clear. Well understood by them and so that’s what we are supporting them and working with them to get – to make sure that regulatory pathway is clear. And so, once that is cleared up and we hope that we will be able to happen in the coming months, we’ll be able to then enter into the definitive agreement and then be able to provide more information in that regard. A – Sonny Bal: Correct, this is Sonny, that’s a better way of phrasing, there aren’t any issues and just to go back to your earlier question on the default notices, there aren’t any lawsuits, no issues, no missed payments or not in default of any covenants, just to provide some clarification.

Mike Matson

Analyst

And then, just on Brazil, how quickly can the revenues ramp there, it sounds like you are expecting to generate revenue pretty quickly, I mean is that, can that be a material contributor to your revenue this year?

Ty Lombardi

Analyst

It will be a contributor for sure and we have our partner online down there and – but it will be a new introduction and so [indiscernible] will be a contributor. It will take a little time for that to ramp up and so we anticipate little more upside in 2016, but it will definitely be a contribution to our revenue lines in 2015 as well.

Mike Matson

Analyst

All right. That’s all I have. Thanks a lot.

Sonny Bal

Analyst

Thanks, Mike.

Operator

Operator

Thank you. That’s all the questions that we have in the queue for today. I’d like to turn the call over to Dr. Sonny Bal for closing remarks.

Sonny Bal

Analyst

Great. Well thanks to everyone who participated on the call. I’d like to reiterate my excitement for this year. We truly believe the orthopedic market is at an inflection point and looking for innovation, given the legacy products made out of metal and plastic are getting several decades old. And this is evidenced in our recent discussions with potential OEM and private-label partners as well as with surgeons and distributors. So this is a great opportunity for our company Amedica to prove the benefits of silicon nitride technology and get wider and more rapid adoption of this material. I am very optimistic that our team can take advantage of this opportunity and I look forward to providing you another update in November. Thank you.

Operator

Operator

Ladies and gentlemen, thank you again for your participation in today’s conference. This now conclude the program and you may all disconnect your telephone lines. Everyone have a great day.