Globus Medical Inc (GMED) 2015 Q4 法說會逐字稿

Good afternoon. My name is Kyle, and I will be your conference operator today. At this time, I'd like to welcome everyone to the Globus Medical Q4 and FY15 earnings conference call.

(Operator Instructions)

Thank you. Mr. Kearns, you may begin your conference.

Thank you, Kyle. Thank you for being with us today. Joining today's call from Globus Medical will be David Paul, Chairman and CEO; Dan Scavilla, Senior Vice President and CFO; Anthony Williams, President; and Dave Demski, Group President of Emerging Technologies. This review is being made available via webcast, accessible through the Investor Relations section of the Globus Medical website, at www.globusmedical.com.

Before we begin, let me remind you that some of the statements made during this review are or may be considered forward-looking statements. Our Form 10-K, and our subsequent filings with the Securities and Exchange Commission, identify certain factors that could cause our actual results to differ materially from those projected in any forward-looking statements made today. Our SEC filings, including the 10-K, are available on our website. We do not undertake to update any forward-looking statements as a result of new information, or future events or developments.

Our discussion today will also include certain financial measures that are not calculated in accordance with Generally Accepted Accounting Principles, or GAAP. We believe these non-GAAP financial measures provide additional information pertinent to our business performance. These non-GAAP financial measures should not be considered replacements for, and should be read together with, the most directly comparable GAAP financial measures. Reconciliations to the most directly comparable GAAP measures are available in the schedules accompanying the press release, and on the Investor Relations section of the Globus Medical website.

With that, I'll now turn the call over to David Paul, our Chairman and CEO.

Thank you, Brian, and good evening everyone. 2015 was a great year for Globus Medical. Sales grew by 14.8% as reported, and by 16% on a constant currency basis, reaching $544.8 million, and full year adjusted EBITDA remained at a healthy 36.2% of sales. 2015 was also a busy year, as we launched 14 new products, made steady progress on our robotics program, continued to build out our product development team and product portfolio in trauma, significantly expanded our research capabilities, completed the integration of Transplant Technologies of Texas, and acquired Branch, and began significant expansion of our in-house manufacturing capabilities.

We were able to generate record financial results, despite ongoing investments in multiple fronts, by executing on our strategy of robust product innovation, sales force expansion, and disciplined expense control. I am very proud of the performance of our team in 2015, and remain confident in our ability to increase profitability at or above our sales growth rates, over time.

At the beginning of last year, I identified five major ongoing initiatives. The CREO platform, MIS TLIF, robotics, regenerative biologics, and expansion of our research capabilities. Our success with three of them, expansion of CREO, MIS TLIF, and regenerative biologics, including TTOT, has helped us have a better than expected year in 2015, and we made steady progress in the other two areas of research and robotics, as well.

As we look ahead into 2016, I would like to speak to six organizational initiatives for this upcoming year. New product introductions, robotics and trauma, sales force expansion, regenerative biologics, in-house manufacturing, and research.

One, ongoing innovative product launches have been the lifeblood of our growth since inception. We intend to continue that trend in 2016, as we have several products that are on deck for launch this year.

Further expansion of the CREO platform, with side loading and 65 options, will bolster our industry-leading technology platform. Advancements to our Best-in-Class lumbar and cervical standalone inter-body offerings will also launch in 2016.

To date, the CREO platform has been used in approximately 15,000 surgeries worldwide. And our lumbar and cervical standalone inter-body devices have been used in 50,000 surgeries. Surgeon feedback has been exceptional, and we see a lot of opportunities for gaining market share in these major spine segments.

Two, we are working on getting our initial robotics and trauma products on the market. Our goal is to launch the first robotics product in 2016. The excitement and feedback from surgeons reviewing this product in development has been tangible, and we're extremely excited on its launch.

As a reminder, the first robotics product is a surgical aid for navigating and facilitating surgical access, implant sizing, positioning and placement. The system is being designed to enable surgeons to perform procedures with greater accuracy, safety and reproducibility, but with less exposure to radiation.

On the trauma side, we have significantly expanded our product development team, and made steady progress in the development of several products. Our goal is to have several systems with FDA by the end of the year.

Three, while we have made headway in expanding our worldwide sales force in 2015, we are planning on improving our pace and efficiency of doing this in 2016. We have bolstered our management structure, to more effectively grow the commercial sales footprint in the US and international markets. While we had a challenging year in international sales, as did our competitors, we also see opportunities to better focus and align our efforts there.

Four, efforts to grow our market share in regenerative biologics continued in 2015, and led to us, to a very strong year, with growth over 38%, excluding TTOT. This was primarily the result of KINEX and SIGNIFY, our bioactive glass products, in addition to Allograft offerings from TTOT, sold through our sales force. We plan on introducing several more new products in 2016, to leverage TTOT's current portfolio across ours sales force.

We also purchased a facility in San Antonio for regenerative biologics, and are currently building it out with clean rooms and tissue processing facilities. Our goal is to have sales of regenerative biologics account for roughly 10% to 15% of our spine sales, over the next five years.

Five, we have invested about $7 million in equipment in 2015, and plan to make more investments in 2016 and 2017 to grow our in-house manufacturing capacity at Branch, to reach 50% of all our needs. We had a benefit of $900,000 in gross margin in 2015, and expect this to reach $5.5 million in 2016. In addition, we are excited about the synergies and efficiencies it is bringing to our new product time lines, as we are able to complete an early make-by decision, and also benefit from involving manufacturing much earlier in the process.

Six, we have invested significantly in in-house research, by expanding our capabilities and laboratory space. Including biomechanical testing, histology, histomorphometry, radiographic image analysis, particle analysis, videography, and post-market clinical research, with a vision to create the best musculoskeletal research facility in the world.

We're also increasing investments in surgeon training and education, for attendings as well as residents and fellows. This is a key component of our efforts in advancing patient care, through ongoing training and CME opportunities for the surgeon community. Globus' performance in 2015 was in the backdrop of healthy procedural growth, while US pricing pressure remained in the mid single digits throughout the whole year. There were no significant developments regarding [pods] during the year.

In summary, as we are investing and building towards our long-term goal of creating a diversified musculoskeletal growth company, we remain laser focused on the opportunity to grow our spine business worldwide. We remain excited about our prospects, as we continue to execute on our growth strategy of rapid new product introductions and worldwide sales force expansion, while maintaining a continued focus on profitability and cash flow. I will now turn the call over to Dan.

Thanks, David, and good evening everyone. We finished 2015 with record sales and earnings. Worldwide sales for Q4 were $142.6 million, up 10.7% as reported, or 11.5% in constant currency versus Q4 2014. The fourth quarter marked the sixth consecutive quarter of sequential growth, with an increase of over $5 million versus Q3 2015.

US sales for Q4 increased 11.9%, driven by continued market penetration and strong new product sales. The Q4 growth rate versus previous quarters in 2015 reflects the anniversary of the TTOT acquisition in October. International revenues were negative 1% as reported, or plus 7.9% at constant currency.

Innovative fusion sales for Q4 increased to $73.6 million, or 4.4%, driven by CREO, our newest pedicle screw platform. Disruptive technology sales increased to $69 million, or 18.3%, driven by continued strength in our expandable technology, CREO MIS and biologics. Worldwide sales for the year were $544.8 million, up 14.8% as reported, or 16% in constant currency, with US sales increasing by 16.6%, and international sales at negative 1.5% as reported, or plus 10.2% in constant currency.

Turning to the rest of the P&L, Q4 gross profit was 75.4%, compared to 75.7% in Q4 2014. As stated in our previous earnings releases, the year-on-year change is attributed to a shift in mix associated with biologics, which typically have a lower margin than other implants, and the impact of foreign currency rates on our international sales.

Included in gross profit is approximately $500,000, or 40 basis points improvement, driven by the continued Branch Medical benefits, working through inventory and into COGS. This benefit will continue as planned, and increase in 2016, where we are forecasting a $5.5 million cost of goods sold benefit from the Branch Medical acquisition for the full year.

Research and development expenses for the fourth quarter were $9.8 million, or 6.9% of sales, as compared to $8.4 million, or 6.5%, for the same period in 2014. The planned increase in spending supports new initiatives such as robotics, trauma, expansion of our product development capabilities, and continued investment in research. Investments in emerging technologies impacted Q4 EPS by approximately $0.02.

SG&A expenses for the fourth quarter were $53.4 million, or 37.4%, as compared to $47.7 million, or 37%, in Q4 2014. The 40 basis point increase is primarily due to a one-time acquisition provision adjustment in 2014, not repeated in 2015. The improvement in SG&A, compared to Q3 2015, is attributed primarily to ongoing leverage, coupled with higher Q4 sales.

Provision for litigation reflects a one-time $11.7 million pretax gain related to the previously announced Synthes settlement for four patent infringement lawsuits concerning spinal implant technologies. The after-tax net income gain was $7.6 million, and the EPS lift was approximately $0.07 in Q4.

Fourth-quarter net income was $37.6 million, an increase of 36% as reported, versus Q4 2014. Fully diluted GAAP earnings per share in Q4 were $0.39, compared to $0.29 in Q4 2014. After adjusting for the provision for litigation impacts of approximately $0.07 favorable in 2015, and $0.01 unfavorable in 2014, the fully diluted non-GAAP earnings per share in Q4 were $0.32, versus $0.30 in Q4 2014.

In addition, the Q4 2014 EPS includes a one-time gain of approximately $0.01, driven by adjustments for prior-year tax audits that were not repeated in 2015. Adjusted EBITDA for the fourth quarter was 37.7% compared to 36.7% in Q4 2014, driven through continued leveraging and stronger sales.

We ended the quarter with $329.8 million of cash, cash equivalents and marketable securities. Free cash flow for Q4 was $30.7 million. Full-year free cash flow was $73.9 million, reflecting stronger operating cash flow, partially offset by increased investment activity of $19 million, driven by the purchase of the robotics and biologic buildings and in-house manufacturing equipment.

In addition, we continued to invest in instrument sets to support new product launches and increased market penetration. The Company remains debt-free.

Our 2016 full-year guidance remains at $583 million in sales, with an EPS of $1.20 per share. Guidance reflects the strong 2015 quarterly comps, the anniversary of the TTOT acquisition, which contributed $19.7 million of sales in 2015, and the current economic uncertainty, including the stronger dollar.

We will now open up the call for questions.

(Operator Instructions)

Your first question comes from the line of Jason Wittes from Brean Capital. Your line is open.

Wanted to just ask, you mentioned a list of initiatives for this year. I'm just curious to think about your guidance, in terms of what's included in those initiatives, and what's going to actually impact the P&L this year? So if you don't mind, just to go through that list, and give us a sense of when that should actually impact, that would be very helpful.

Jason, thank you for the call. All six initiatives are included in our guidance, so we don't expect this to affect our guidance.

I guess what I'm saying is, when I think about the growth rates in the bottom line EPS numbers that you provided, I should assume there is some contribution from all six of these initiatives that you mentioned initially. For instance, the robot and trauma, will they be major contributors, or modest contributors to 2016, when I think about it?

I think I get this one, Jason. So basically, keep in mind that we're looking to do the filings for the robot maybe midpoint this year. Seeking approval at the end of this year, but as I said before, we would not see, or we do not anticipate having, revenues for that. Same with trauma. We're working on that, we're ramping up our expenses, and we're investing in that. And while we will seek approvals this year, we're not counting on any kind of revenues.

So in our guidance are the ongoing investments for the emerging technologies. But at this point, we don't think, and we don't anticipate, having revenues or any income related to those items. The other objects -- the other things are ongoing, and as part of the base business, just looking for that continued growth, as part, as we said earlier, of the guidance.

Okay. And then just on the trauma business, have you -- could you just gives us a sense of how you look to build out the sales force? And when we should start to see that build-out to become, I guess, more aggressive?

Jason, this is Dave Demski. Yes, our sales force, our plan to build the sales force, is going to be an exclusive sales force. We haven't made a determination beyond that. We'll probably hire sales leadership towards the middle of this year, and be hiring reps potentially towards the end of the year, depending upon how we do with the FDA, and how the product approval process is going.

Okay. Thank you.

Your next question comes from the line of Jonathan Demchick from Morgan Stanley. Your line is open.

Hello. Can you hear me okay?

We can, Jonathan. There's was some static, but it's cleared up now.

Perfect. So thanks for taking the questions. Wanted to start off with your cash balance, and the potential use of it. I believe at the end of this year, your cash balance was now around $350 million, or following some of the market pressure, about 15% of your market cap.

So clearly, the financial markets have had a pretty substantial impact, across valuations, across medical devices. Has this disruption altered, I guess, any conversations you may be having with potential targets? And again, are the targets you're looking at largely the same that we've talked about in the past, trauma or international players?

Yes. So Jonathan, we're sitting at just under $330 million with cash and marketable securities, and those type items. And you're right, we said we're patient in what we're going to invest in. We're going to make sure it has the right return. We still feel the market's hot, a little bit overpriced. Certainly, the recent disruptions occurring throughout the market may be cooling down some expectations.

So we're not looking to make any moves in the near term, or suddenly seeing anything, because of the shift in the last two months, that would change our pattern. We realize we have an asset here, we're going to apply it in the right sustained growth, and we just continue, through Brian and the team, to evaluate what the right opportunities are.

Great. And a quick follow-up, just on sales growth. Obviously, when we look at it on a comp adjusted or momentum basis, sales decelerated a bit in the fourth quarter. Guidance seems to imply, I guess, further deceleration into 2016.

So I guess the question is, is there anything, I guess, different that you're seeing in the market right now, either competitively or broadly across the space? Or secondly, is that, I guess, just more conservative? Is it [a play] that you just want to make sure that you are still guiding towards a lower number?

Yes, no, two things, Jonathan. So first off, keep in mind that we were signaling this all along in 2015, is, we knew October was coming, and that was the anniversary of TTOT. And so when you really look at that impact, among the quarters into Q4, that truly is the anniversary of TTOT. When you tease that out, and you look at our base growth, we feel it's fairly consistent, and reflects the number of days, et cetera, that were there.

As you look into this year, again, when you've got the tough comps of 2015 that we're going to come at, the fact that we've anniversaried TTOT, and have no other additional acquisitions to go at. And when you look at market uncertainties, we just want to make sure we've got the right number that appears achievable, that we can go after. And so we still stick with that guidance of 7%, facing all those items.

Just one last quick question. On the in-house research topic that you guys chatted on, how should we be thinking about the tangible benefits from this? Is this more of a way to create more data supporting the efficacy of your products? Or is this more of a way to create brand loyalty through training and additional touch points with the docs?

Thank you for the question. It's several of those things. But in addition, it's also, there's really a dearth of actual research being done in any commercial company in the United States. Most of the research is generally done in the university settings. So what we tried to do is, we've put together a group of individuals and research who have no product development responsibilities, who are focused on the clinical problems that we hear from surgeons every day.

So we're trying to [unearth] and identify clinical problems that we can then develop solutions. I see that as the primary benefit. But in addition to that, we can also benefit a lot by doing all the testing, including animal testing, in-house, where our product development folks benefit by looking at the actual testing being done. Whether it's mechanical, biomechanical, or animal testing, being done under our roof.

So while we don't conduct the actual animal testing at Globus, everything subsequent to necropsy, we do it here. That is the histology, histomorphometry, which brings a lot of benefit to our product development folks, who can then look at this.

And the other piece that we are trying to build in this is the post-market clinical research piece. And we see that, over the long term, we're going to need to prove the efficacy of our products, even though they're 510(k) cleared without a clinical study. We want to do clinical trials on most of our products, so we can prove efficacy and safety, over the long term, in clinical trials. So those are the three major objectives.

Secondary objective is to also focus on surgeon education and training that we're driving through this MERC, or musculoskeletal education and research center. So mainly research, and also education.

Great. Thank you very much.

Your next question comes from the line of Craig Bijou from Wells Fargo. Your line is open.

Hi, guys. Thanks for taking the question. I wanted to start with EPS guidance for 2016. Recognizing that you guys beat your guidance by $0.03, and if -- using the adjusted number. And if you take out $0.01 for the one-time item that you mentioned, Dan, and then back out $0.04 for the device tax, it looks like EPS growth might be slower than the top line. So I just wanted to see if I'm -- am I doing that math correctly? And if it is, what's the reason for that?

So Craig, a lot of moving parts. So the $0.01 adjustment is really from 2014. That was a favorable tax -- multi-year tax settlement that occurred in 2014 that wasn't there in 2015. So the $0.01 adjustment isn't something that I would back in or out of 2015, to adjust that way.

So really, I guess the way we'd look at it now, the way we're structured, is even as we've said early on, through the Investor Day and ongoing, is our intent is to grow the bottom line in line with sales, while investing in several things, including emerging technologies.

I think as we do the adjustments by stripping out the med device tax right now, I think we still look like the bottom and top are growing at approximately the same rate. That's really where we're lining up right now.

Okay. That's helpful. And if I could ask, on the seasonality or the quarterly cadence, I know you guys don't give quarterly revenue. If you look at, over the last couple years, it looks like Q1, for instance, is roughly 24% of overall sales. I want to ask, is there any reason to think seasonality or quarterly cadence would be different in 2016?

We don't give, really guidance on the quarters, as you know. I think, looking at historical trends, from a modeling point of view, would be certainly the personal decision. I think as you look at the market, I'll leave that in your hands, and go along those lines.

Okay. And if I could just squeeze one more in. Gross margin in 2016, a lot of moving pieces, with the device tax coming out, some negative mix, and then the Branch benefit. I know you also don't provide gross margin or specific guidance, but any way -- how should we think about that, relative to 2015?

Yes, I think that's a fair question. And so first off, to your point, you're going to have some ongoing mid-single-digit price degradation, as we've talked about all the time. I think that's fair to model forward. Certainly, looking at what we've openly declared, that $5.5 million Branch benefit would come through.

And then if you do the math from our earlier announcement, you would have about $9 million pretax related to -- call it about $8 million, really, pretax related to the med device. And so I think you're going to see a lift in GP, really driven by med device suspension, as well as the benefit coming off of the balance sheet and into the cost of goods sold. I would use that modeling assumption.

Great, thanks for taking the questions.

Thank you.

Your next question comes from the line of Kaila Krum from William Blair. Your line is open.

Hi, guys. Thanks for taking my questions. So when I look at 2015 performance, you all delivered $70 million in incremental revenues for the full year, and then you mentioned TTOT was about $20 million for the full year, in 2015. So perhaps $18 million of that was incremental from 2014 levels. So that's still a $52 million increase in incremental dollars that you delivered in 2015. So that's a pretty big uptick from the $40 million increase we saw in 2014.

So I understand that in 2014, there was the impact of the distributor loss. But it would just be helpful to parse out the drivers of that acceleration in performance we saw. Was it new products? Was it pull-through associated with TTOT? Sales force expansion? And then, why or why wouldn't these drivers be sustainable into 2016?

Thank you for the question, Kaila. Some of -- as I mentioned earlier on in my prepared remarks, we did have a better than expected year in 2015, because of the success we enjoyed with CREO, with ALTERA, and some of our expandable cages, and with the biologics, aside from the TTOT sales.

So I don't think that that's how we're looking at 2016. I think our annual guidance, at this point, appears what we are comfortable with. As far as your math on the TTOT, I think the incremental is about $15 million in 2015, not $18 million. So we still did just about as good, or better, than 2014 to 2015.

Okay. Great. That's helpful. And then just to follow-up on EBITDA, 37.7% is pretty incredible. But can you just parse out the drivers of that 90 basis point increase, sequentially? And perhaps, specifically, a bit more clarity around the impact to EBITDA, the increased level of trauma and robotics investments is having today? So that we can understand how the underlying business would be performing, ex those investments?

Yes, certainly. This is Dan. I think what we can take a look at, really, is, we are able to still gain some leveraging through the P&L, and it's primarily US driven. So when you look at the shift, year on year, from 2014 to 2015, on the EBITDA side of that, it really is going to be related to how we're utilizing sets and depreciation of those sets.

We're able to get gains from our US SG&A lines, a little bit, that are helping us out for that. I think that was probably the first thing along those things. You had asked a second part of the question, which I'm not sure I fully understood.

So I just was curious, the impact to EBITDA today, that the increased level of investments in the trauma and robotic segments is having on EBITDA today?

Yes, so really, what it said in the script is, right now, we have about a $0.02 EPS drag with that. So if you work your way backwards, you can figure out the math along those lines. Roughly about $2 million would be pretax, by the time you grossed it up. Fairly similar to what we had also said in Q3. So I would tell you that's probably the quarterly impacts that are out there. The other leveraging is there that gives us the benefit to deliver that bottom line.

And as you know, we're also sensitive about that EBITDA. We're not looking to drive that number much higher. We think we were successful with where it's landing, but it's not going to climb up from there. We've got many things to invest in. We still commit to that mid-30s EBITDA.

Kaila, and one other point I'd add to Dan is, we look at EBITDA, also, on an annual basis. And from quarter to quarter, it can vary somewhat, but we're still looking towards the mid-30s EBITDA rate.

Great. Thank you.

Your next question comes from the line of Kyle Rose from Canaccord Genuity. Your line is open.

Great. Thank you very much for taking my questions. Can you hear me all right?

Yes, we can hear you, Kyle.

First wanted to start on some of the investments in Branch. You talked about the $7 million in manufacturing spend in 2015, and then expectations for more investments in 2016 and 2017. Just wondered if you could give any insight into the cadence of some of those investments?

And then also, should we expect those to be of the same amount, or within the same range that we saw in 2015? Or will there be a more significant investment, as we think about it, moving forward.

Thanks, Kyle. Yes -- so you're right. So obviously, the full acquisition and integration occurring in 2015, as well as us utilizing space by either redesigning the existing footprint or moving some of it into the existing Globus business, allowed us to buy some more manufacturing equipment, which obviously allows us to, over time, increase the amount of in-house manufacturing that's there.

That's really the gist of what we've been investing in, and are in the mid-stride of investing in, to take Branch from approximately 25% of our implant supply up to 50%, over the next several years. The investment will be multi-year, as the team announced early on. And so certainly, as you look at what we spent in 2015, you probably would see something equivalent in 2016. We would need to re-evaluate, beyond that, as to what's needed, based on demand.

Great. Thank you. And then just any expectations, as far as new sales rep hires in 2016? And didn't know if you could give us the number where you ended 2015, as well? Just an understanding of productivity and expectations for 2016, on a hiring standpoint?

Kyle, we generally don't provide those numbers, Kyle. But we continue to strive to be the destination of choice for competitive talent. And as I mentioned in my prepared remarks, we're trying, this year, to do better than we've done in the past. And we've tweaked our organizational structure to get us to that point. But we don't give out those numbers.

Great. And then just last question on OUS growth. What are your expectations for OUS growth, when we look at 2016 and beyond? And can you just talk about how some of the changing dynamics of the emerging markets may have impacted that expectation of moving forward? And just, what are some of the highest priority geographies, when we think about it?

As I mentioned, we've had a challenging year in international sales, but so did all our competitors, because of the market conditions and currency fluctuations. We had some significant price issues in Belgium and some other markets.

But beyond all this, we still feel like we have about a 1% or 1.5% market share. So while these factors are there, I still see tremendous opportunities for us to better focus and align our efforts there. And our goal, long term, is to grow that at much faster rates than our US business, because there's a lot of opportunity there.

Great. Thank you very much.

Thank you.

Your next question comes from the line of David Roman from Goldman Sachs. Your line is open.

Hi, this is actually Kyle filling in for David. Good afternoon, and thanks for taking the questions.

Hi, Kyle.

With TTOT having annualized, and disruptive technologies returning to a more normal rate of growth in 2016, could you just provide an update on where your biologics portfolio sits, in the context of the total business, as a percentage of sales? And how that franchise is growing, going forward?

Sure, Kyle. I'll tell you, we're actually really pleased with where our regenerative biologics are. And as David mentioned, is, just that core business, excluding TTOT, was up 38% for the year. And so I think we're seeing good headway with some of our key products, more uptake, as we get out with the docs and utilize that more. We've always stated that we feel that we should be at least at the market share, and we define that as roughly 10%.

So we're thinking our sales overall, 10% should come over the next several years, through the biologics business, as we grow it. I would tell you right now, if you picked in that mid-range, that's where we are, closer to 4% or 5% And this is part of the journey, but I think we're right where we want to be, as far as closing that gap.

And then, some of the other medical device companies that we follow have expressed a view that there's been a strong carryover of procedure volume growth, from Q4 in 2015 into Q1. Is that a dynamic that you've noticed playing out in your end markets, thus far in 2016?

Thanks. You know, we actually don't comment right now on the current quarter, so I'm going to refrain from that one.

Understood. Thanks very much.

Your next question comes from the line of Richard Newitter from Leerink Partners. Your line is open.

Thanks for taking the questions. I just wanted to start, or go back, to follow up on the OUS question. I think in the past, you guys have obviously talked about, you're going through some changes, some internal changes, management changes, to restructure the way I think you approach certain territories.

I guess my question is -- and you've said in the past that you had expected a return to double-digit growth, within a reasonable time frame. And that was like the beginning of last year, and that would have probably suggested double-digit growth potential in 2016. Does the environment you're seeing in the international region change that ability to achieve a ramp up to double digits, either exiting the year or at some point in 2016? Would love your thoughts there.

I'd love to think that, at least while exiting 2016, we'll be at those rates. But some of the things that happened in international markets last year, and were pretty unexpected, with the pricing situation in Belgium and then in other markets, as well as the currency fluctuations.

But as far as internal issues are concerned, we worked on restructuring there. We continue to make some changes that we think are needed.

And as I mentioned before, we only have 1.5% market share, according to our estimation. So I think, these extraneous factors aside, we should do a better job internally of growing our international business. And I know our team here at the table is extremely focused in on getting this turned around.

Yes, and Rich, what I would think is this. While certainly, we're pleased that we do have double-digit growth at 10.2%, we're thinking it needs to be, obviously, higher than that. And as we've told you, as we look at structures, both here in Audubon, as well as throughout the markets, I think we're looking at quarter-on-quarter improvement.

So I don't think it's a switch, where we're there over one quarter. But 2016, I think given the strong dollar, economic uncertainties, that may be a challenge for us. We're not necessarily declaring that yet. But I think as we look to bring this back to the growth rate we want, we're still putting in place everything internally we need to achieve that.

Okay. Thank you. Dan, also, I feel like we ask you this every quarter. But now you've been at the Company for a longer period of time, and you've mentioned tax planning initiatives in the past. Would love to get an update there, and any kind of time lines for lowering the tax rate that you'd be willing to share? Thanks.

Sure, Rich. So a couple things. We're looking at a couple of simple US structures, and we feel like we may have the ability, later on in 2016, to realize those. We're in the implementation phase of that now.

I think they'll be modest, so I don't think it's anything to bank on [or really] look at yet, but it's one of the first starts. At the same time, we've already engaged a third-party firm to work with us on some of the international.

I would tell you that I have a better defined plan of what we want to do, and it's right now being formulated, so I probably won't go into the exact details. But the thought would be to utilize some the strength right now, early on in 2016, to actually begin building that out in the first half, over, say, Q2, Q3 of this year, and then looking for some benefits in 2017.

So I will have a better answer, probably into Q2, as we get done this investigative work. But I feel fairly positive that we have a viable route to have a tax impact, as we grow international, and as we start seeing some of the benefits in the later years of our long-range plan.

Maybe just remind us of what's assumed for your [$1.17] guide on tax rate?

Yes, it's about 35%. It's probably just a little bit under that, probably 34.5%, because we would have factored in the R&D tax credit with that.

Okay. Great. And then just one last one. You've mentioned in the past that your TTOT ambitions with that asset are to expand into some new areas, where you haven't been present, like stem cell, potentially. Would love any updates on those initiatives.

Is the stem cell product in the works? What could be a time line to potentially see that come to market? Thank you.

Thank you, Rich. We have an active product in development right now. I'm not ready yet to commit to a date, but we have a product in development, and hope to get it out soon.

Thanks.

Your next question comes from the line of Matt Miksic from UBS. Your line is open.

Hey, guys, thanks for taking the questions. Just a couple of follow-ups on the P&L and margins, and then I have one market-related question for Dave or David, if I may. So Dan, you mentioned in an answer to an earlier question that the spend -- and you gave the $0.02, which is helpful -- spend on emerging Technologies was around $2 million. So just quick, obvious, simple math on that puts Q4 EBITDA margins of the core business, if we want to call it that, at like 39%, if I'm seeing that right. Is that right?

I think, doing that math, Matt, you're right. You can get into that. That's in the range.

And then just to take that a step further, not to push you guys too much, but that does include what I would characterize as a drag from the international business. Is that not correct?

Not really. There's some that goes on there. We've always said some pricing is different with that. But listen, at the end of the day, you know that we're going to run this as a mid-30s EBITDA Company. We look for strength in some areas. We want to redirect it now, strategically, to grow and invest in other areas.

I'm with you 100%.

Yes. And as you know, we're going to make sure we don't let one area of the business overheat, nor are we going to let one business of the area underperform, without us coming in and making sure we can get the right outcomes.

Matt, and I'm sure you know this, but here are a lot of timing issues with this. So I wouldn't take one quarter's EBITDA and extrapolate. When you think about this, you should look at it always with the annual number in mind, and that's where we want to be in the mid-30s. So whether it's our national sales meeting, or other things, there are always timing issues with this also involved.

Totally understand.

(multiple speakers) getting coverage, though.

Totally understand. And I guess I'm asking the question more to put into context the dry powder that you have, to continue to invest this year. So the follow-on to that is, as we think about this full year, you've been making investments in trauma and robotics, which is great, and we're getting closer to commercialization with robotics, and then trauma to follow.

Should we think about that investment -- you're at $2 million a quarter, in the fourth quarter and the third quarter-ish. As you get to commercialization, and you do start hiring sales management in the back half of the year, whenever it is, should we think about, those are the things that get you from what is a pretty strong core number down to your target in the mid-30s? Is that the right -- you're teeing up these things, finally, to enter the market? Is that the right way to think about it?

I think that's a reasonable way to think about it, Matt, because you're going to have a couple things. Not only are you going to continue an increase in R&D, as you're getting there, and starting to finish up some of the items, and go into some of the next gen. But as we've said before, we're going to enter into the pre-commercialization ramp-up of our sales force, and that organization. So you're absolutely right. You're going to see some higher spend in there, pre-revenue, as planned.

That's helpful. And then the market question, if I could, David or Dave, one of the questions I get a lot is, are the bigger players, the legacy players, the Medtronic and DePuys of the world, going to wake up and get tougher? And make it tougher for you to compete in this market, and to take the kind of share that you've taken?

And I'd just love to hear what you're seeing in the market, if there's any change. I know that you are always adjusting and evolving your face to the market. But what's your expectation, in terms of what it's going to take to compete maybe next year, the year after, that's a little different than last year and the year before?

Thank you, Matt. As I've said before, we compete with some of the best medical device companies in the world, the top medical device companies in the world. So I never take them lightly.

That being said, when I look out at the competitive landscape in spine, I continue to see tremendous opportunities for us to keep growing. Because I don't see anything different that is being done by our larger competitors. So I continue to see a lot of opportunities, not only in continued product innovation, but also in attracting sales talent.

Super. Thanks.

Thanks.

Your next he question comes from Dave Turkaly from JMP Securities. Your line is open.

Thanks. Maybe just a follow-up on a quasi-market question. But we've been hearing more about posterior fixation options, outside of pedicle screws. And you guys highlighted CREO, both on the innovative and the disruptive side.

I guess I'd just love to get any color, on the either price or growth, or what you're seeing in that core market? And then an opinion, what will you think of some of these newer options? Thank you.

Thank you, Dave. As we've -- our innovative fusion is growing at about 4% to 5% a year, and that's where we look at CREO. But when we look at CREO, we have the regular pedicle screws, but then we break out CREO MIS as disruptive, and that's growing much faster. I didn't understand the second part of your question. If you could repeat it, it will be great.

Just asking, as we're seeing some of these newer technologies that are posterior fixation, but not pedicle screws, your thoughts on that, given CREO is a very successful product, and you guys have been so strong in pedicle screws in the past. I guess just your thoughts on --

Are you -- so I'm guessing you're referring to interspinous devices and segmental fixation devices, without using pedicle screws?

That's right.

Okay. Those, we don't see as a big threat, frankly, because the indications for those type of devices are pretty narrow, and it's stenosis. That's not what the majority of degenerative conditions are in the lumbar spine.

And additionally, if you look at all the interspinous devices, the longer term clinical data that's been coming out is showing that those are not as good as we all originally thought they were. So we don't see that being an issue for our pedicle screw business, per se.

Thanks a lot.

Your next question comes from the line of Bob Hopkins from Bank of America Bank of America-Merrill Lynch. Your line is open.

This is Travis Steed on for Bob. So I just wanted to talk about the landscape in 2016, versus the landscape in 2015. A year ago, you guided to roughly 6% organic growth. But ex the acquisition, you delivered closer to 13% to 14%. And in 2016, you're guiding to 7%. And as you think about 2016 relative to 2015, the competitive landscape, product cycles, ability to hire reps, are there any different headwinds or tailwinds that we should be aware of in 2015 versus 2016?

Not really, Travis. I would tell you that what I look at is, we've had incredibly strong quarters in 2015, and we're just making sure we understand that they're the beginning point. So it's certainly a different level to start growth from.

And as you said, we had the benefit of the acquisition coming through, and that anniversaried. So that, again, adds to those numbers. And then as -- again, as you look at the market in any day, and you see the ups and downs, including today, just that level of uncertainty, we want to make sure the economic uncertainty, and the dollar versus some of the other currencies. We really do feel like calling out the 7% right now, with those items, is the right thing to do.

Okay. Thanks. All my other questions have been answered.

Thank you.

Your next question comes from the line of Matt O'Brien from Piper Jaffray.

To follow up a little bit on David's earlier question, on new technologies that are coming out to address the spine market, without the need for pedicle screws. I'm not talking -- I think you were talking, David, about LSS products, and this is specifically around [MEVO] from LDR. I'd love to get your thoughts on that, as well as the IGA platform from NuVasive, and how that may impact your guys, going forward?

I'm not too familiar with the LDR project that you're talking about, Matt. But I can tell you about the IGA, and that's the surgical navigation system that NuVasive has.

And to me, I look at global alignment in the lumbar spine as something that we've been working on for the last 10 years, with our inter-body devices. And I don't see that affecting our business, per se.

I look at how we've been able to achieve low doses in the lumbar spine, by expandable technology, and we've been preaching about global alignment for a long time. So I don't think that's going to affect us. But I would love to hear more about what you mentioned with the LDR alternative to pedicle screws.

Sure. It's just a device that goes in the back, that helps to fixate the device, plus the spacer that's included, as well. But it's something we can follow up on offline.

Just -- and then -- just speaking of spacers, there are expandable spacers. There are some competitive ones that are coming to market now. And can you just help frame the potential competitive threat to your business? Because as I recall, a bigger chunk of your revenues come from expandable spacers. Thank you.

Thank you. We launched the first expandable cage in 2011, and we have some companies now coming out with expandable devices. But -- we're biased, but we don't think anything is close to being a real competitor yet to us.

We also have tens of patents and intellectual properties surrounding our expandable technology, and we've been adding prolifically to that IP portfolio, so we feel very strong in our IP position. That being said, we still expect some serious competition, in the near future, with expandable. But as of right now, we haven't yet seen that affecting us.

Great. Thank you.

Thank you, Matt.

There are no further questions at this time. This brings us to the end of Globus Medical's Q4 and FY15 earnings conference. You may now disconnect.