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Xtant Medical Holdings, Inc. (XTNT)

Q4 2012 Earnings Call· Wed, Mar 27, 2013

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Transcript

Operator

Operator

Greetings and welcome to the Bacterin International 2012 Results call. At this time all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star, zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Rich Cockrell, President of Cockrell Group. Thank you, Mr. Cockrell. You may begin.

Rich Cockrell

President

Good morning and thank you for joining us today for Bacterin’s full year 2012 financial results call. On the call today are Guy Cook, Bacterin’s Chief Executive Officer, and John Gandolfo, Chief Financial Officer. Yesterday the company issued a press release announcing calendar year 2012 financial results within which the company reported record 2012 revenues of approximately 33 million. That was a 9% increase over the reported 2011 revenues. Today’s call is being made available via the Investor Relations website at investor.bacterin.com. Following remarks by management, we will open the call to your questions. We expect the duration of the call to be approximately one hour. During the course of this call, management may make certain forward-looking statements regarding future events of the company and its future performance. These forward-looking statements reflect Bacterin’s current perspective on existing trends and information can be identified by such words as expect, plan, will, may, anticipate, believe, should, intends, and other words of similar meaning. Any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, including those noted in the Risk Factors section of the company’s annual report on Form 10-K. Actual results may differ materially from those projected in these forward-looking statements. For the benefit of those of you who may be listening to the replay, this call was held and recorded on March 27 at approximately 10 am Eastern time. Since then, the company may have made additional announcements related to the topics discussed. Please reference the company’s most recent press releases and current filings with the SEC. Bacterin declines any attempts or obligations to update these forward-looking statements. And with that, I’d like to turn the call over to Guy.

Guy Cook

Management

Thanks Rich, and good morning everyone. Thank you for joining us today to discuss our fourth quarter and full year 2012 results. I’ll begin by providing highlights of the year and John will conclude with a more detailed review of results. 2012 had both positive and negative developments for Bacterin. We successfully grew our business in the wake of a competitive and evolving healthcare environment. We significantly expanded our processing capabilities, exiting our back order situation in second quarter 2012, which was a significant constraint in early 2012. As we continue to develop our market for innovative biological scaffolds for tissue regeneration, we introduced 10 new allographt product lines and recently introduced our amniotic tissue product into the marketplace. We now have a more robust portfolio of regenerative biologics that addresses the spectrum of specialty biologic needs and we continue our path of becoming a preferred direct biologic supplier for both our surgeon and hospital partners. Our products are supported by excellent clinical evidence with fusion rates in the high 90th percentile, and as such our first two peer review articles were published this year. On the reimbursement front, our hMatrix product received its Q code on December 31, 2012. We also improved our distribution capabilities by signing two new GPO accounts, Novation and Premier. Furthermore, we completed a $20 million financing with OrbiMed. This provided the company with working capital to achieve its near-term strategic objectives. We also expanded our sales and marketing capabilities and currently have one national sales manager, five executive VPs, 12 regional managers, 26 director sales representatives, three distribution managers, and three associate sales reps. Our sales infrastructure now supports over 200 independent distributors and during the year we completely reworked our sales and marketing materials. We expanded our sales pipeline with opportunities that position…

John Gandolfo

Chief Financial Officer

Thanks, Guy. I’d like to remind our listeners to refer to the 2012 earnings press release issued yesterday and also our Form 10-K for the calendar year 2012, which will be filed later today. As Guy mentioned, we were able to increase our yearly revenues from $30.1 million in 2011 to approximately $33 million in 2012. The increase of approximately $2.8 million was largely the result of increased sales generated from our direct sales force and independent distributors compared to 2011. Gross profit for the year increased $1.6 million from $21 million in 2011 to $22.6 million in 2012, an increase of 8%. Our gross margin percentage for the year was 69%, a 1% decrease from the year before. For the fourth quarter 2012, we reported a gross margin of 56%, up from 44% in 2011. The fourth quarter of 2012 includes $671,000 for an increase in reserves and the write-off of expired products. Excluding these adjustments, gross margin would have been 65% in the fourth quarter of 2012. In addition, fourth quarter 2012 gross margins were negatively impacted by increased price discounts for hospital accounts and higher sales of lower gross margin products compared to the prior quarter. Going forward, we anticipate gross margins to be 65 to 70% excluding the impact of sales to corporate entities. Sales and marketing expenses decreased to $15.6 million during the year as compared to approximately $18.5 million for 2011. As a percentage of revenue, selling and marketing expenses decreased to 47% in 2012 from 61% in the prior year. The decreases were primarily the result of more variable compensation paid to our direct sales force compared to fixed salaries earned in the comparable period of 2011 as well as a lower corporate sales commission structure for direct sales reps and independent distributors.…

Operator

Operator

Thank you. [Operator instructions] Our first question comes from the line of Bruce Jackson with Northland Capital Markets. Please proceed with your question. Bruce Jackson – Northland Capital Markets: Good morning. Can you hear me okay?

Guy Cook

Management

Yes Bruce. Bruce Jackson – Northland Capital Markets: Okay. So first, I know this is a tough metric to come up with, but do you have a rough idea of how much of your revenue came from direct sales versus distributors?

John Gandolfo

Chief Financial Officer

The same amount that it was in the prior quarter – about a third is coming from the direct sales reps, a third from distributors, and another third coming from the reps working with distributors in certain markets. Bruce Jackson – Northland Capital Markets: Okay. And then there was a stocking order last year. Were there any stocking orders in this current quarter?

John Gandolfo

Chief Financial Officer

No. No stocking orders. That was part of the—and we highlighted this when we pre-announced our revenues. Part of the reason for the negative variance was that we did expect some large sales to corporate entities to close that did not close. Bruce Jackson – Northland Capital Markets: And then with those particular orders, were they deferred? Do you think that you might get them in future quarters?

John Gandolfo

Chief Financial Officer

Actually there were a couple of them. Some were executed in the first quarter and others, I wouldn’t say they were deferred. I think another one that we were looking at ended up being a lost opportunity. Bruce Jackson – Northland Capital Markets: Okay. Was there any impact from Hurricane Sandy in terms of your ship days or your sales?

Guy Cook

Management

Yeah, there was some. Our northeast sales did suffer probably 10 to 20% in that Q4. I think probably two to three weeks were actually probably lost of our northeast sales. Bruce Jackson – Northland Capital Markets: Okay. And then with your group purchasing contracts, so we brought on Novation in May of last year and we brought on Premier in July. Can you talk to us a little bit about what the pricing dynamic has been with those contracts?

Guy Cook

Management

It’s mostly good with those contracts. It gives us quicker access, it speeds up the sales cycle. The downside is that more of our sales move through a discount of approximately 15%. In the beginning of 2012, probably only 20% of our sales moved through the GPO accounts, and by the end of the year almost all of our major accounts, probably 90% of our sales moved through the GPO accounts. So that was quite a bit of a headwind as well. Bruce Jackson – Northland Capital Markets: So we would expect that to kind of annualize in the back half of this year?

Guy Cook

Management

We do. I think as almost all of our sales are moving through them now, I think we’ve seen the bulk of that headwind. Bruce Jackson – Northland Capital Markets: Okay. Last question on the operating expense cost savings with the 1.3 million reduction, just to be clear on this. Are you expecting your operating expenses to be down 1.3 million year-over-year, or down 1.3 million from what you originally planned for 2013?

John Gandolfo

Chief Financial Officer

No, we expect it to be down 3 million from what we initially planned for 2013. 1.7 million of that is savings of current expenses and 1.3 million of it are planned expenditures which will not be made. Bruce Jackson – Northland Capital Markets: Okay, got it.

John Gandolfo

Chief Financial Officer

And just to clarify, that those, as I mentioned, are across the whole organization in terms of those reductions. Bruce Jackson – Northland Capital Markets: Okay, got it. Thank you very much.

John Gandolfo

Chief Financial Officer

Thanks Bruce.

Operator

Operator

Our next question comes from the line of Anthony Vendetti with Maxim Group. Please proceed with your question. Anthony Vendetti – Maxim Group: Thanks. Just a couple questions. Guy, I was wondering if you had any update on the anti-microbial products, how that’s proceeding.

Guy Cook

Management

Yeah, it’s still moving through. We’re still doing our testing on that, but I think given the current regulatory environment, I think we’d be looking to a partner to help commercialize that product to continue the trials and studies that need to be done and justify or show efficacy. So I think at this point, it continues to move through the FDA. We will look for a partner. Anthony Vendetti – Maxim Group: Okay. And then can you talk a little bit about the physician-owned distributors, how that’s impacting the competitive landscape and what you’re doing to try to address these new competitors and just general pricing pressure?

Guy Cook

Management

Yeah. We see most of our competition from distributorships rather than from other processors and other tissue banks. They are a force in the market. We did lose one of our major accounts to a POD – that was probably almost 5% of our 2011 business, something in that range. They continue to get stronger in the market and we continue to see more of the sales move through the POD channels, but we are beginning to counter that. We have begun to allow our direct representatives and our sales infrastructure to work with them to supply the various PODs around the country. But it is an interesting dynamic in the market place. I know the OIG just recently put out a special alert – I think that was yesterday. It will be interesting to see what the future of those organizations may be, but they are definitely a dynamic in the market right now. Anthony Vendetti – Maxim Group: Okay. And then just lastly, the two warning letters from the FDA, you said that’s through the OIG. You have a team or consultants working on the response to that. What is it really surrounding, and is this just you have to go through the process but you expect a successful resolution. If you could just give a little more color on that.

Guy Cook

Management

Yeah, sure. The two warning letters, one was for devices and one was for biologics. We did hire some outside professionals to help us draft that response. We have completed all responses at this time and they’ve acknowledged the response. We do expect a successful outcome for the FDA warning letters. They are mostly systems, internal systems, and we had begun already updating our internal systems from the original audit date and we had put that in our response; just the FDA chose not to acknowledge that in the response before they issued the warning letter. So we have already updated and incorporated a lot of those recommendations into our systems at this point, so we do expect a successful outcome. Independent of that, we also received an OIG letter specifically referring to a surgeon referral network that had limited life. It was effective for a small number of surgeons, approximately six surgeons. It was discontinued quickly after it was started, so we also expect a successful resolution for that. Anthony Vendetti – Maxim Group: Okay, great. Thanks.

Operator

Operator

Our next question comes from the line of Matt O’Brien with William Blair. Please proceed with your question. Matt O’Brien – William Blair: Morning, thanks for taking the question. Was hoping that we could talk a little bit more about the dynamics in the market right now with your current user base. Guy and John, I think you typically provide the number of surgeons that are using your products. Has that changed? Have you been losing accounts versus gaining more accounts? And just a bit more on the pricing environment – is it strictly a POD issue or is there something more going on that you’re facing?

John Gandolfo

Chief Financial Officer

In terms of the hospital accounts, we have increased the hospital accounts in the fourth quarter. I think the figure was 1,164 were the hospital accounts in the fourth quarter, and that was up from, I think, between 900 in the third quarter. But as Guy referred to, we did lose a very high, probably top five account for the company to a physician-owned distributor in the quarter. So when you look at the hospital account numbers, your logical conclusion would be, well, why didn’t your sales increase if you’re selling to more hospitals? But that’s certainly skewed by losing that one large hospital account, as well as a few others. But that gives you the metric from the overall hospital accounts, so we are increasing penetration; but we were negatively impacted by the loss of that key account. Matt O’Brien – William Blair: And I think you were dancing around it a little bit before, but can you give us a sense from a revenue perspective how big of a loss that one account was?

Guy Cook

Management

(Inaudible) 5%, it’s about 1.5 million, 1.7 million. Matt O’Brien – William Blair: Okay, so as we think into 2013 and the guidance you’re providing is something like 15 to 20% growth, you just grew 20%, you’re losing a bigger accounts – I’m sure you lost bigger accounts in ’11 as well. But losing a bigger account, you’ve got the OIG issue to think about as well as the warning letters and a more challenging environment from a pricing perspective. How can you get comfortable around that guidance that you provided? Is there something on a product line basis that we should be focusing on that will drive a big chunk of that growth?

Guy Cook

Management

Yeah, the hMatrix product, our dermal scaffold, we do expect that to be 5 to 10% of our sales. We are gaining excellent traction with those surgeons. We have signed up some major accounts already, so we think that’s—you know, we have already signed up an individual account that’s about 2 to 3 million, and so we do think that’s going to be a big driver for us. We’ve also partnered with a major hospital chain in the southwest where we’ve become a preferred vendor for that chain. You know, their spend is about 20 to 25 million in biologics, so we think it’s going to be a big driver for our top line as well. And we continue to partner with some large corporate entities that have the ability to help drive that top line. So at this point, we feel pretty comfortable that we have enough growth initiatives in place and the major setbacks we’ve had, such as the loss of those accounts, have been attenuated. Matt O’Brien – William Blair: Okay. And then Guy, you mentioned that you were doing some work in Europe. Can you give us a sense for what kind of impact that should be here in 2013 and then maybe even into next year?

Guy Cook

Management

Yeah. As part of the group we just signed up, they do have access in the EU, and so we expect to get into both the Middle East, EU and Russia with that account. We think that’s going to help drive international growth. We’re also expanding quite a bit in South America, Latin America, and also forming a partnership with the Australian group. So we expect our international sales to grow significantly in this year as well. Matt O’Brien – William Blair: Okay. And sorry, just one quick one back on hMatrix – how fast did that product grow in Q4?

John Gandolfo

Chief Financial Officer

I think it was a small percentage in Q4. We really started to see the increase in Q1 of this year, Matt. Matt O’Brien – William Blair: Okay. And then last one – John, I think this one’s for you. Can you just give us a sense—I think in the release you mentioned getting to operating profitability here in 2013, and there’s a bunch of moving parts and I’m trying to figure out how international impacts the gross margin and then your cost reduction initiatives. But just how with the revenue base of, call it $39 million, do we get to profitability this year?

John Gandolfo

Chief Financial Officer

Okay. So if you take a look at it, the gross margins, as I mentioned, we expect to be between 65 to 70%, and that’s excluding anything we’re dealing with these corporate, larger corporate stocking orders. The corporate accounts will have a negative impact on that number because they are discounted much higher because there is much higher sales transactions that they are taking risk on. The offset or the mitigating factor against that will be that we will not be paying any sales commission on that. So the overall gross margin you’ll see for the year will really depend upon what the mix is of those corporate accounts, but if you take the guidance we’ve given, if you take a midpoint margin of 67% as the gross margin on that guidance, if you factor in that we expect our sales and marketing expenses to be probably around 39% of sales this year and G&A to come in roughly at 20 to 23%, that will get us to the point where would have positive operating income as well as generating positive EBITDA for the year. Matt O’Brien – William Blair: Okay, that all makes sense. Any idea for—you know, with these commission reductions, have you seen any turnover within the sales force so far?

Guy Cook

Management

No, not voluntary turnover. We have eliminated some positions for some low producers, but no. We feel like our turnover issues are behind us and we feel pretty confident moving forward. Matt O’Brien – William Blair: Okay, great. Thank you so much.

John Gandolfo

Chief Financial Officer

Thanks.

Operator

Operator

Our next question comes from the line of Nathan Kelly with Noble Financial. Please proceed with your question. Nathan Kelly – Noble Financial: Thanks for taking the questions. Just a couple questions – a lot of them were answered. On the last call, you discussed additional regen medicine technology. Are there any updates there, and do you guys plan to move forward with the amniotic membrane and the nerve product?

Guy Cook

Management

Yeah. We did just begin commercializing the amnion product. We are still doing some internal evaluations with RP docs (phon), so we do expect to see an uptick from those products in 2013, the remainder of the year. The nerve guides are still in development. They’re probably going to be in 2014. We continue to work with that research partner, but we do expect it to be a minimally processed tissue and so we do think it will come to market quickly. We’re just doing the internal evaluations right now. Nathan Kelly – Noble Financial: Will that be in competition with your hMatrix product or how does that come into the mix?

Guy Cook

Management

We think the amnion can be used in conjunction with hMatrix. We think the hMatrix product has the right handling properties, the right structural strength for filling a lot of those defects where the amnion does not. So it can be used as an outer layer membrane. The amnion can also be morselized and infused into the matrix, so we’re looking at it a few different ways. But again, we want to see some clinical efficacy before we jump full bore into that. Nathan Kelly – Noble Financial: And then back to the PODs for just a quick follow-up question there. What are they doing, you think—what’s the dynamic there that they are able to take away accounts from a company like yourself with 75 reps on board? What are they doing different, or what do you think the aspects are there?

Guy Cook

Management

I will leave that to the OIG to investigate, but the PODs, it’s well known that physician-owned distributorships participate in the profits of the distributorship. That’s the dynamic. They’ve been out there for a long time and that’s part of the landscape that our sales people have to deal with. We compete on price, quality and service. Nathan Kelly – Noble Financial: Mm-hmm.

John Gandolfo

Chief Financial Officer

But what we are seeing, Nathan, in certain accounts is that physicians who are no longer part of physician-owned distributorships are deciding because maybe their income is being cut to join with a physician-owned distributor. That’s where in some of these specific instances where the landscape changed for us. It’s not unique to Bacterin; it’s really impacting the whole industry at this point in time. Nathan Kelly – Noble Financial: Mm-hmm. And then the international business, do you guys—is there any expectation there when you may make an announcement on your first distribution there, or are you already distributing? Can you give us some color on expectations for 2013?

Guy Cook

Management

Yeah, we don’t make announcements for every country that we get into, but we have—we typically are signing up larger distributors now that might have access or sub-distributorship relationships in, say, 10 or 12 countries at a time. But we have not traditionally made announcements for any specific country that we have recently gotten into. Nathan Kelly – Noble Financial: Is that factor—is the international business factored into your guidance?

John Gandolfo

Chief Financial Officer

Yes, it is. Nathan Kelly – Noble Financial: And then just one last question – on the international business, what do you expect for margins there, gross margins?

John Gandolfo

Chief Financial Officer

It will depend upon the product mix, but you’re probably looking at, I would say, a gross margin on no sales of about 50%, and correspondingly what you lose on the gross margin you will not be paying a sales commission on, so you’ll make—the overall impact to operating income is usually only, believe it or not, like a 1 or 2% difference between a traditional sale and one of these sales. That’s how the economics work. Nathan Kelly – Noble Financial: And percentage of business, can you give us some guidance on that for 2013 on international, your percentage of business there—percentage of revenue?

John Gandolfo

Chief Financial Officer

Yeah, I don’t think it’s expected to be a large material portion of it, maybe 5%. Nathan Kelly – Noble Financial: Okay. All right, thanks a lot for taking the questions.

John Gandolfo

Chief Financial Officer

Thanks Nathan.

Operator

Operator

Our next question comes from the line of Greg Garner with Singular Research. Please proceed with your question. Greg Garner – Singular Research: Yes, thanks for taking my question. A follow up on the discussion of the PODs – I’m just trying to better understand that distribution channel. So they are distributing different products, and if the leading product, INFUSE, which is losing share, if that’s much more expensive than Bacterin products, I’m wondering is this distribution channel not that price sensitive then?

John Gandolfo

Chief Financial Officer

I think that it is price sensitive, and we’re still obviously less costly than INFUSE is, but the price sensitivity comes from the other biologic players that might be selling to that physician-owned distributor. Greg Garner – Singular Research: Okay. And any sense for what percentage of the market share that the PODs are doing a good job addressing in the bone replacement?

Guy Cook

Management

I think it’s typically thought about 20 to 30% of the spine market is moving through the POD distribution channel. Greg Garner – Singular Research: Okay. Given that Bacterin’s products are so much less expensive than the INFUSE products, what the current discussions there from the marketing people and the dynamics in talking to new clients or even existing customers? Is performance just assumed and so pricing happens to be the main focus of attention, or is there something else? I’m just trying to understand that. It seems as if there’s been a movement in what the criteria is to place orders in the last year, year and a half, from performance to more of a pricing.

Guy Cook

Management

I’d say, Greg, the market shifted as we expected away from INFUSE into allographt tissues, how they—you know, safer and robust performance. You’re getting statistically equivalent results with our product with INFUSE from our small clinical trial that we did, our small clinical study that we did. Since that market has shifted into that area, the hospital has been more forceful in ensuring pricing, so we are competing against a host of competitors in that space and not necessarily against the INFUSE product any more. Greg Garner – Singular Research: Okay. And in your guidance for revenues, does that include any stock orders, corporate stock orders?

John Gandolfo

Chief Financial Officer

Well, the guidance we gave is 38 to $40 million without the impact of those stocking orders. Greg Garner – Singular Research: Without any—okay. And it was also mentioned in the pre-release something about a potential upside with additional sales channels. Is that referencing the international, or was there something else there?

John Gandolfo

Chief Financial Officer

No, that’s referencing the sales to the corporate accounts, the stocking order sales to corporate accounts. Greg Garner – Singular Research: Okay. All right, thank you much.

Operator

Operator

Our next question comes from the line of Bruce Jackson with Northland Capital Markets. Please proceed with your question. Bruce Jackson – Northland Capital Markets: Hi, just one quick follow-up on the product side. So you launched the subchondral bone product at AOS. Do you have any of that in your guidance for 2013?

Guy Cook

Management

Yeah, we do. We’re getting a pretty healthy response, surgeon response for using the product. We do think that product’s probably going to be in the little less than 5% range for this year, but we are experiencing good traction and we do have some papers coming out regarding the success of that product, so we remain quite hopeful for that. Bruce Jackson – Northland Capital Markets: And with those papers, where and when do you think those might come out?

Guy Cook

Management

It’s always a little bit of a crapshoot for this, but I think we do expect them to come out this year. That’s probably the best of a forecast I can give you. Bruce Jackson – Northland Capital Markets: Okay, great. Thank you.

Operator

Operator

The next question comes from the line of Danny Gaddis (ph), who is a private investor. Please proceed with your question.

Danny Gaddis

Analyst

Hi, thanks for taking my call. I was just wondering since we’re already near the end of the first quarter if you have any preliminary numbers on what the revenues might be for the first quarter, and when your next quarterly earnings report will be for this quarter?

John Gandolfo

Chief Financial Officer

We don’t have any preliminary quarterly number for this quarter. The visibility in this business, and I’ve mentioned this previously, is that you find out about the quarter pretty much two weeks after the quarter ends because a lot of the hospital accounts don’t get the information as to their usage back to you. So right now, we don’t have any update from that. We do plan on—we don’t have a firm date yet, but it will probably be around the first week of May that we would do the conference call.

Danny Gaddis

Analyst

Thank you.

Operator

Operator

Ladies and gentlemen, as a reminder, if you would like to ask a question, please press star, one on your telephone keypad. Our next question comes from the line of Nathan Kelly from Noble Financial. Please proceed with your question. Nathan Kelly – Noble Financial: Hey guys, just one quick follow-up question on capital. So expectations for cash burn for 2013, and what was the current debt balance with OrbiMed?

John Gandolfo

Chief Financial Officer

Well, the current debt balance hasn’t changed at all because the payments are four years of interest only and three years of principal and interest, so it’s still $20 million debt outstanding. I think from a burn standpoint, based upon the guidance that we’ve given, we’re looking at net cash flow—and this is after repayment to OrbiMed of the interest payments and the royalty payments. You’re probably looking at a negative cash flow of about 2 million for the year with the back part of the year becoming positive. Nathan Kelly – Noble Financial: Okay. So the long-term portion on the balance sheet of the OrbiMed royalty, that’s part of the debt, correct?

John Gandolfo

Chief Financial Officer

Yeah, if you go to—and it’s a little complex from a GAAP standpoint. You would expect to see $20 million as the total debt amount, but if you go to the footnote on long-term debt, you’ll see that you take out a debt discount portion of it to get to the balance sheet number. But the cash that has to be repaid, there’s still $20 million. Nathan Kelly – Noble Financial: Okay, thanks a lot.

Operator

Operator

It seems there are no further questions at this time. I’d like to turn the floor back over for closing comments.

Guy Cook

Management

Okay, thank you very much. We appreciate you guys joining us for the call today, and as John mentioned, first quarter call will be in the first or second week of May. We’ll have an announcement out to give you the exact date. Again, thank you very much and look forward to hearing back from you.

Operator

Operator

This concludes today’s teleconference. You may disconnect your lines at this time, and thank you for your participation.