Brian Kearns - Globus Medical, Inc. David C. Paul - Globus Medical, Inc. Daniel T. Scavilla - Globus Medical, Inc. David M. Demski - Globus Medical, Inc. Anthony L. Williams - Globus Medical, Inc..
Matthew Miksic - UBS Securities LLC David L. Turkaly - JMP Securities LLC Jonathan Demchick - Morgan Stanley & Co. LLC Craig William Bijou - Wells Fargo Securities LLC Richard S. Newitter - Leerink Partners LLC Matthew O'Brien - Piper Jaffray & Co. Kyle William Rose - Canaccord Genuity, Inc. Kaila P. Krum - William Blair & Co.
LLC Steven Lichtman - Oppenheimer & Co., Inc..
Good evening. My name is Crystal, and I will be your conference operator today. At this time, I would like to welcome everyone to the Globus Medical First Quarter 2017 Earnings Release Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. Thank you.
Mr. Brian Kearns, you may begin your conference..
Thank you, Crystal, and thank you all 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 for the 2016 fiscal year 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, and 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 IR section of the Globus Medical website. With that, I'll now turn the call over to David Paul, our Chairman and CEO..
osteogenic cells, osteoconductive scaffold and an osteoconductive growth factor. An optimized ratio of demineralized cortical fibers to cancellous chips in ViaCell is designed for enhanced cellular proliferation and exceptional handling.
Early feedback from surgeons has been encouraging, and we are excited to have added ViaCell to our suite of regenerative biologics. Ongoing innovative product launches in spine have been the lifeblood of our growth since inception. We intend to continue this trend in 2017, as several new products are on deck for launch during the rest of the year.
Turning to international sales efforts. The Alphatec international business added $15.2 million of sales in the first quarter of 2017. We are pleased with the quarter, but continue to have discussions to integrate the Alphatec distributor network into ours.
While we have maintained virtually all of the Alphatec business to date, we expect to experience some dissynergies as we rationalize some markets throughout 2017, and we're taking a prudent approach with guidance to account for this likelihood.
We're particularly pleased with our progress in new product regulatory submissions in Japan and look forward to introducing Globus products there in the second half of 2017. We're investing in several new sales territories in Japan to grow aggressively in a previously underinvested market.
Further investments in sets and replenishment inventory are anticipated as we transition the customer base to Globus products. On our core international sales, we continue to build out our sales management structure and to harmonize business and sales processes with the U.S. Our plan is to return to healthy growth by the end of 2017.
Our effort to significantly expand our presence worldwide continues, with specific emphasis on Japan, the United Kingdom, Germany, Australia and India. Emerging Technologies. The CE Marked Excelsius GPS system was showcased and well-received at EuroSpine, NASS and at the recently concluded AAOS (9:44) conferences.
We continue to make steady progress in preparation for worldwide launch, including logistics, supply chain, manufacturing and support. In the U.S., you will recall that we made the FDA submission in late 2016 and are working towards FDA clearance.
Our capital sales force has been hired, trained and is ready to help Globus enter this nascent but potentially large market. Excelsius GPS is the only product designed with optimized workflow for the operating room surgeon and staff and fully integrates with our implant technologies.
Our belief in the tremendous potential of this game-changing technology to improve patient outcomes and safety has led us to increase investments in R&D, technology acquisition, and distribution channels.
On the trauma side, we have several products with FDA, have begun receiving 510(k) clearances and expect to begin launching these products in the second half of 2017. We have begun building out the commercial organization and will accelerate this effort throughout the year.
These emerging technology opportunities will enable us to further strengthen our business and create a larger footprint within customer hospitals and institutions while contributing to increasing sales growth rates over the next few years, all in support of our drive to reach $1 billion in sales.
In summary, as we invest and build towards our long-term goal of creating a diversified musculoskeletal growth company, we remain highly focused on the opportunity to grow our spine business worldwide.
We're 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 our focus on profitability and cash flow. Over the remainder of the year, we're looking forward to seeing further progress in accelerating U.S.
sales force expansion, launching innovative new spine products, completing the integration of the Alphatec international business, and taking our first steps into the robotics and trauma markets. I will now turn the call over to Dan..
Thanks, David, and good evening, everyone. Q1 2017 sales were $155.8 million, growing 11.9% as reported, or 12.1% in constant currency, against our toughest quarterly comp of the year. GAAP net income was $28.7 million and non-GAAP net income was $30.7 million, delivering $0.32 fully diluted non-GAAP earnings per share and 37.1% EBITDA.
Focusing on sales, the performance was driven by two main factors. First, international sales for the quarter were $26.1 million, growing 123.4% as reported, or 126.5% in constant currency, driven by the acquired Alphatec assets which contributed $15.2 million for the quarter.
We are very pleased with the topline and bottomline contribution of this acquisition to date. We are in the process of integrating the distribution network of the two organizations. To date, we have not lost any significant business as we have maintained parallel distribution in product lines while we work through negotiations.
I would caution in extrapolating the Q1 results to the full year, as there remains significant risk, that we will experience some dissynergies as we rationalize certain markets throughout 2017. The full year guidance we provided factors in the dissynergies we believe are likely. Second, U.S.
sales for the quarter were $129.7 million, 1.6% higher than Q1 2016 and 1.7% sequentially higher than Q4 2016. While this result does not meet our long-term expectations, we continue to see acceleration in growth and sequential improvements in the U.S.
business, with year-over-year organic growth rates improving from negative 4.1% in Q3 2016 to negative 2.7% in Q4 to the positive 1.6% in the most recent quarter. We're starting to see the results of structural improvements we have made to the business and believe we'll see continued momentum and quarterly improvements to revenue throughout the year.
Disruptive technology sales for the quarter increased to $73.9 million or 6.8% growth with continued strength in our expandable technologies, COALITION MIS, INDEPENDENCE MIS, CREO MIS and Biologics. Innovative fusion sales for Q1 were $81.9 million or 16.9% growth driven by Alphatec assets, QUARTEX and the CREO pedicle screw system.
Turning to the rest of the P&L. Q1 gross profit was 77.2% compared to 77.4% in Q1 2016. This quarter included a one-time, 120 basis point gain for vendor refunds and reflected the continued strength of our in-house manufacturing program, which contributed $1.9 million in the quarter.
Full year gross profit projections remain strong at 76%, incorporating the full year effect of price pressure, biologics and Alphatec product mix. Research and development expenses for the first quarter were $10.7 million or 6.8% of sales compared to 7.2% in Q1 2016.
The increased spend in absolute dollar terms is driven by investments in Emerging Technologies and Biologics. SG&A expenses for the first quarter were $67.1 million or 43% compared to 38.6% in Q1 2016.
The increase is primarily driven by the inclusion of Alphatec international cost and the pre-revenue robotic commercial organization build that were not present in Q1 2016. The income tax rate for Q1 was 32.3%, a reduction of 350 basis points compared to 35.8% in Q1 2016.
The change in the effective tax rate is due to the Q1 2016 one-time negative impact for deferred tax assets related to the reorganization of our domestic legal structure. This is combined with an ongoing benefit for the adoption of ASU 2016-09 for stock compensation accounting beginning in Q1 2017.
GAAP first quarter net income was $28.7 million and non-GAAP net income was $30.7 million. Q1 GAAP diluted earnings per share were $0.30 and non-GAAP diluted earnings per share were $0.32. Investments in Emerging Technologies negatively impacted Q1 EPS by approximately $0.04. Adjusted EBITDA for the first quarter was $57.8 million or 37.1%.
We ended the quarter with $389.2 million of cash, cash equivalents and marketable securities. Net cash provided by operating activities for Q1 was $53.5 million (sic) [$53.4 million] (17:10), and free cash flow was $41.9 million. The company remains debt free.
The company reaffirms guidance for full year 2017 sales of approximately $625 million and non-GAAP diluted earnings per share of the $1.27. We will now open the call for questions..
Your first question comes from Matt Miksic [UBS]..
Hi. It's Matt Miksic from UBS. Thanks for taking my question. So, I had one. I know you're not the biggest fish in the pond here in terms of spine in the U.S., but you're an important one and I've asked the question of other folks in the quarter.
I just wanted to get a sense if you could give any color in terms of how the quarter sort of paced down for you in terms of seasonality or anything unusual, when you look at year-over-year comps, or missing days or anything like that. That kind of sort of tone in the market would be very helpful. And then I have one follow-up..
Matt, thank you for the question. We didn't see anything unusual in the quarter. We had a decent quarter, not a great quarter, but we didn't see anything unusual from month-to-month in the first quarter..
That's helpful. And just a clarity on that. Can you remind us of what the impact of the sales rep losses were last year, in this quarter or how – within a full quarter impact, partial quarter impact? Just trying to match it up..
See, we didn't really give out of sales rep loss impact last year. If you remember, we lost some folks in Q4 of 2015 and then into Q1. So, it really stymied our growth in 2016. But I don't believe we quantified a number for Q1 of 2016..
Okay. And then partial quarter I guess, prior year partial quarter impact. And so I guess what I'm getting at is the second quarter, if I'm not mistaken.
Is it the right way to think about it, that that would be almost a clean quarter, but it will be sort of a full year-over-year apples-to-apples growth?.
Matt, the way 2016 unfolded, as David said, is we started to see some higher than average attrition occur in Q4 carried into Q1, and we really saw both Q2 and Q3 have an impact that occurred. From my numbers, I looked at Q3 as probably the floor, that's what we called out the inflection point when we started changing around.
So, I still think you're going to see some change in those comps in both Q2 and Q3..
Okay. That's helpful. And then if I could just one on – another one of the topic that we get a lot of questions on, and I guess there's an open debate on how important robotics are going to be. And, David, you mentioned, you got some fairly good feedback and it looked like you were getting some good feedback in AAOS (20:44).
If you could you give any color as to where you've seen more interest, is it across a certain type of surgeon or a certain type of hospital? Are folks more interested in one element of the value proposition than another? Just what you've learned so far would be very helpful..
Thank you, Matt, for the question. When we started off, what we really saw, an immediate impact, was for deformity surgery and for MIS surgeons who are already familiar with MIS techniques. But as we have received feedback at these conferences, it's been pretty universal on how well it has been received.
People like to use it in all sorts of applications, including deformity. Placement of screws seem to be obvious immediate benefit. Our internal results are tremendous in terms of time, dose and accuracy. And as we have heard from surgeons at these conferences, they're pretty excited on how they can use this product to treat the gamut of spine surgery..
Well, thanks..
Your next question comes from Dave Turkaly [JMP Securities]..
Thanks. Just a follow-up on one of those – the pricing in the quarter.
Any color on sort of – any changes there in terms of what you saw in 1Q 2017?.
Hey, Dave. No, actually we didn't. We saw it really be relatively stable mid-single digits. Did not see anything unusual in the first quarter from any of the previous quarters..
Great. Then just on the sort of your motion preservation technology. It's been a while since, I think, we talked about this.
But I was curious, could you give us an update on SECURE-C and, maybe, if that product is growing? And have you seen any impact since Zimmer bought LDR in terms of how that market is progressing?.
Thanks for the question, Dave. We haven't seen any impact on the purchase of LDR by Zimmer. But we haven't been too thrilled about our progress with SECURE-C. We now have seven-year data coming out showing incredible results on cervical arthroplasty. We're looking forward to publishing this.
Meanwhile, in Europe we have two next-generation devices already being sold. So, we're still excited about arthroplasty in the right indication. And we're just looking around, seeing how the regulatory climate in the U.S. can potentially change, which would make us get much more active in clinical trials..
Thanks a lot..
Your next question comes from Jonathan Demchick [Morgan Stanley]..
Hello. Thanks for taking my questions. Just had a quick one on Alphatec. I was wondering if you could kind of walk through the rationalization process for the business.
Clearly, the acquisition has outperformed thus far, but it sounds like this outperformance is more slower winding down of the parts of the businesses that you may not keep rather than significant growth of the business that's staying. So, I guess, I was hoping if you could kind of pare down those two parts.
Like, how fast do you think the business is growing that you plan on keeping versus how much of the outperformance is really just kind of the winding down process and how long does that take?.
Hey, Jonathan. Thank you for the question.
As I mentioned at the last call, we have an agreement with Alphatec for many years to have supply of their products, but what we are trying to do is make sure we get the registrations done in every country and then get the product rolled out – Globus products rolled out once we have a clear agreement with the distributor principals in that geography if they don't overlap with Globus.
It's a little bit more complicated when they overlap with Globus. But even stepping further back, one of the primary reasons for us to do this deal was to get access to Japan, and that's what our excitement is really fueled by.
We've had – lot of our products are going through the PMDA process now, and we want to get these products out beginning of the second half of this year, and Japan is going to be much more than half of all these sales and that's what we're really extremely enthused about..
Thank you. Thank you for the clarity. And just a follow-up on SG&A expense. It was a bit elevated this quarter. You guys outlined pretty well that it was related to both Alphatec as well as some of the pre-revenue for robotics.
But I was also wondering if there was anything more one-time in nature there, just given the strong rep hire quarter or if we should be expecting basically that SG&A expense kind of grow off of this level for the rest of the year..
Hey. Thanks, Jon. So, a couple of things. I mean, certainly, we have been communicating pretty openly that we will begin to have the robotic commercial team and eventually build up the trauma team out there. So, no surprise that that number where it is right now pre-revenue with us.
There's a few smaller one-timer things that occurred out there, but nothing that I would say is worth calling out or looking at, just some basic timing things through the year.
So, it really is driven primarily by the inclusion of Alphatec followed by the increase as you start getting some of the salaries and annualization of salaries of that pre-commercial team. There is a few dribs of other things that just simply are meaningful to call out or model..
Understood. Thank you very much..
Your next question comes from Matt Taylor (26:49)..
Hi. Thanks for taking the question. I guess I just wanted to understand. You talked a little bit about these product launches in the beginning of the call.
Can you talk about how meaningful some of those are between the new deformity addition and the allograft that you talked about? Are there something that you could see any inflection from?.
Matt, thank you for the question. Let me start with the allograft. We've been speaking for a few quarters now about our efforts to grow out our regenerative biologics portfolio. We still feel like we need to get to that 10% to 15% of our sales coming from regenerative biologics. We're getting closer to that point, but we're not quite there yet.
And one piece that we did not have was a stem cell allograft product like ViaCell. And so we're really happy to have a really competitive product in that space, and we think this will be -- this will propel us to get to that 10% to 15% in biologics out of our total sales. The Rod Link Reducer product is something we're really excited about.
It's a different technique of correcting deformity on the operating table, and we work with the Texas Scottish Rite Hospital to develop these sets, and we made a unique set of instruments.
We think it can be applied across all of our deformity systems, and we look forward to working with them and other deformity specialists to keep growing our presence in the deformity market.
The last thing I'll say about the deformity space is we have many exciting initiatives ongoing internally on what we think will be the next generation of treatment for deformity patients, and we are working on that.
We want to see it come to market in Europe later this year, and then later on we'll work on bringing these products to the United States also..
Thanks. And you provided some color on the investments in Emerging Technologies. I was wondering how the investments in the new reps also kind of played into the margins this quarter.
Could you talk about that? And how it will play out through the year as you get leverage from these investments?.
Yes. Matt, it's Dan. So, I would tell you that there's certainly an impact, but it's pretty minimal, to be honest with you. We're going out securing competitive reps, we're doing some deals to get those out there. That's not creating any meaningful impact within SG&A. We can see a lift.
But keep in mind as well, you tend to have some revenues and all go with that. So, the shift that I look at – again, I wouldn't think it will be a main driver that takes us off..
Great. Thank you very much..
Your next question comes from Craig Bijou [Wells Fargo]..
[irrelevancies] (29:34). Hi, guys. Thanks for taking the questions. I wanted to start, and I apologize if I missed this. But the $625 million guidance for the year, you left that unchanged. And just given the Alphatec strong performance in Q1, and I recognized your comments about the rationalization of the business that's beginning to happen.
But just wanted to get an understanding of if any of the components have changed the Alphatec, the $40 million that you had talked about before, and then the $10 million emerging technologies kind of placeholder that you guys put out there..
Thanks, Craig. I would tell you, no. Just to be consistent, what we said through the year out on the street or at different healthcare conferences is we're pleased with where we're going, but we are going to wait until we get through Q2 before we make any type of change in guidance right now.
I mean, as you already highlighted, there's a lot of moving parts, none of which concern us. We have the upcoming rationalization of Alphatec distributors. We have the yet-to-be-approved robotic platform that's out there. And again, we're looking for that sustained return to health of the U.S. business.
We do want to get through Q2 before we reevaluate all that, make that call, and that's the real point right now of just holding off and maintaining the current guidance..
Okay. That's helpful. And then, David, I wanted to touch on – and maybe this is just what I heard in the script, but you said that you were – on the robot, you were working towards FDA clearance. So, I just wanted to make sure or I wanted to see if you guys have been in discussions with the FDA and if Q2 approval is still a realistic possibility..
Thank you for the question, Craig. It's really hard to predict with the agency. We've submitted in late 2016. We received some questions, which we are responding to now. And we hope to have a response back in soon and hope to get clearance shortly thereafter. I really cannot predict the timing.
And we're hoping we'll get it by Q2, but it's left to be seen..
Okay. Thanks. And just a follow-up on that, just kind of joins two of my questions. I mean, is that $10 million – Dan, I guess this is for you, is that kind of going back to – is that still a fair number to think about for the Emerging Technologies, just....
Craig, I would tell you yes for right now. Again keeping in mind that it's pre-approval and, of course, our goal is to always to surpass that. But let's go get the FDA clearance and see how we can do it. So, for now, I'm modeling it without – unchanged until we get further data..
Okay. Thanks for taking the questions, guys..
Thank you, Craig..
Your next question comes from Richard Newitter [Leerink Partners]..
Hi. Thanks for taking the questions.
The first one on one of your products you were talking about, ViaCell, just remind me, when did you start selling that product?.
In the first quarter of this year..
Okay. I guess, did you – how significant was the trialing this quarter? Because one of your competitors called out competitive trialing from stem cell products, and I'm just wondering if kind of you saw better than expected success there.
And then a follow-up on that is, how do you plan on tracking whether or not the initial use is trialing versus kind of actually sticky usage? Because we tended to see doctors switch products pretty cyclically within this category..
Thank you for the question, Rich. We launched the product towards the middle to end of the quarter. We have some great feedback early on. But we don't have a strong sense of how fickle or not fickle these uses are going to be. The early users have liked it and have been repeat users. So, I probably have more to comment about this in Q2..
Okay. That's fair. It's still early. Maybe just one follow-up on the robotics question. I appreciate that it's tough to predict the FDA. But maybe, Dan, you can comment on whether your $10 million Emerging Technologies placeholder, is that something that – let's just say, FDA clearance were to slip into 3Q.
I mean, is that something by default that you would have to change or does an approval have to come in 2Q in order to kind of – just kind of get to your combined $10 million from a robotics figure for the year? Thanks..
I would say probably not, Rich. And I always went in and told everyone, go heavy in Q4 with that just in case that occurs. So, I would not be concerned if this were to bleed over into the beginning of Q3 and would not think it would take us off of any of our abilities to make the $625 million.
And again as we set out in the street, there's a couple of levers we're holding back just to make sure, but we're anticipating the approval. If it slips even a little bit, we're not concerned about that..
Okay. Thank you..
The next question comes from Matthew O'Brien [Piper Jaffray]..
Thanks. Just a follow-up on Richard's question. David, you mentioned these questions that you got back from FDA.
Would you characterize those as out of the norm? Any of them stood out that are particularly problematic?.
Matt, I really don't want to comment on our questions with the FDA. Suffice to say that we feel pretty confident on getting the clearance pretty soon..
Okay. Fair enough. And then heading over to guidance, I know you don't want to talk about it, you don't want to change numbers at this point, but the domestic business did take up. It's got the toughest comp of the year.
Even if Alphatec were to slide down to $40 million that you've talked about, that would assume a pretty meaningful deceleration on a – from a two-year stack perspective in our domestic business.
So, my question is, why would that happen? And then if you can comment within there a little bit about sales force attrition rate as you've been 1 attention personally from a management perspective or productivity of the newer reps that you had hired kind of first half of 2016, just how things are going with respect to some of those metrics..
So, couple things, Matt. First off, sticking with the U.S. core business and its continued cadence, which is really driven by a stabilization of attrition, as well as the on-boarding of our reps, and so we're seeing that go through. We think that that will have a decent cadence that will improve throughout the year, as well as the change in comps.
So, it's really that combination that will occur for us to deliver what we consider that mid single-digit growth within the U.S. core for this year. The Alphatec deceleration that occurs is really about the termination of a contract in shipping. So, I think that's a fairly abrupt change that will occur.
And again, as we work through that, I think that will happen fairly rapidly as opposed to a slow bleed-out, at least from what we're looking at or modeling now. I would tell you, we're pleased with the efficiency of competitive reps that we brought onboard throughout the year of 2016.
And I think we're seeing the benefits that we would hope to see as we enter into the first part of this year..
Got it. Last question for me, on the trauma rollout. I'm going off of memory, which is a little scary, but I think you had said maybe seven to eight product families that you'd be introducing right off the bat.
How many of those families are approved? And then, as we start to exit this year, kind of selling those products, how quickly can you get some of those self-developed products into the U.S.
and then maybe start to really accelerate sharetaking in that category?.
Hey, Matt. This is Dave Demski. We're about two-thirds of the way through that core products bag that we had talked about. And we're looking at a second half launch somewhere late in the third quarter, early in the fourth quarter in terms of having reps and products available..
And the newer ones, Dave?.
I'm sorry, the newer....
The self-developed ones, the kind of innovative disruptive-type technologies you're working on..
I guess I'm a little confused by the term. All of the products we're launching are self-developed and new, so I'm not clear on the distinction..
Sure. I think what you said historically is the first group of products will be kind of more me-too-ish, and then you'll kind of come out with the differentiated ones later on..
This – actually, we have some differentiation built into this first wave. But there – we're starting in – as we're working through the completion, as you complete the product, get it to the FDA, the tasks become more logistics and manufacturing, and those engineers are now cycling into newer products.
So, there's a second wave of products that we've begun development on. We won't see those in the market, probably not til the end of 2018 at the earliest..
Helpful. Thank you..
Sure..
Your next question comes from Kyle Rose [Canacord]]..
Great. Thank you very much.
Can you hear me all right?.
Yeah, we can hear you, Kyle..
Yeah, so just a lot's been asked, but I have one question on the disruptive side of your business. You're hearing more in the market just about competitive, either product launches in the expandable cage market or planned product launches for expendable cages.
Just wanted to see – obviously, you guys have really built that business over the past several years and just, one, if you've seen anything today and kind of from what your guidance contemplates on underlying performance on the disruptive technology side of the business..
Hey, Kyle. It's Dan. So, a couple things. I think folks will expand into this category. We had anticipated that for years. We see that as primarily a cannibalization of their static spacers more than coming after us.
As we look at our own expendables, it remains a strong category, one of the highest growth categories for us as a product line, and we're not seeing kind of competition come in and create any level of disturbance as of yet..
Kyle, just to add to that, we're on our third generation of expendable cages and we've built a tremendous portfolio, intellectual property portfolio around our expendable cages, and we feel really confident about the portfolio we have and the lead we have. So we feel we're in a good position with expendable technology..
Great. Thank you very much.
And then just lastly on M&A, I mean, obviously, a very strong cash position and I think the question gets asked every quarter but just, has there been any changes to your thoughts on your capital deployment and where you – how you view your potential tuck-in acquisitions or M&A?.
Yes. A couple things. I mean, certainly, one of the first responsibilities for us in use of cash is going to be to feed and bring to completion the acquisitions that we have in process, so Excelsius to the market, finishing out branch manufacturing, filling our bone bank. They all remain one of the top priorities.
Keep in mind, with the Alphatec acquisition, the conversion from Alphatec products into the Globus products requires the investment of sets and implants and items that will occur. That said, we're still looking actively and have done several tuck-ins. We'll continue down that path to do that as the opportunities call themselves out..
Great. Thanks for taking the question..
Your next question comes from Kaila Krum [William Blair]..
Hey, guys. Thanks for taking my questions. So, first one on trauma.
So, within trauma, can you just give us some color as far as initial feedback? I think you started gauging market feedback a bit early on at AAOS, and I'm curious just what specifically the comment you're hearing related to those technologies there? And then with the late Q3, early Q4 launch, are you still comfortable with that $2 million in sales as a fair target?.
Hey. Thanks, Kaila. This is Dave Demski.
We're getting some really exciting feedback from trauma surgeons as they come through, and particularly there's several people who are helping us develop those products, and I think they're very excited about the innovation that we've been able to bring to the spinal implant business by carefully listening to our customers, understanding what the market needs are and marrying that up with our engineering prowess to come up with innovation.
And they seem to be, for lack of attention to them, historically that they're excited about us bringing there. So, we're optimistic about that.
And then, in terms of the guidance we gave this year and the $2 million, I think we're still comfortable with that, although as we get closer here, the manufacturing build that we need to do to launch is pretty important for us. So – but at this point, we're comfortable where we are with the guidance..
Okay. And then just a follow-up on Japan. I mean, just how to think Alphatec this year. I know we're fairly early as it relates to integration, but just a bit more color around the market dynamics there, the conversations you're having with the non-exclusive distributors and shifting them over towards exclusivity.
And then, just any comments on the competitive dynamic would be helpful..
Hey, Kyla. It's Anthony. So, just to clarify. Our organization in Japan is almost entirely direct. When David was referring to or maybe as Dan was referring to the distributors, that's true, most of the other countries that we acquired in that transaction. But Japan, well over 90% of our sales in that country are from the direct channel.
But in terms of – so, in terms of the market plan, we've got – we've submitted a handful of products to the PMDA, as – I'm sure you know that process is quite lengthy.
But we're working our way through, and we do expect to start getting clearances early in the third quarter, with the expectation of getting those products launched as quickly as we can after we have approval.
The direct relationship there is going to make that a little bit easier, and we think we can use some of our more advanced technologies to really grow the business in Japan through using those products..
Got it. Okay. Perfect. Thank you..
Yes..
And your last question comes from Steve Lichtman [Oppenheimer]..
Great. Thanks. Hi, guys.
Dan, on the Alphatec rationalization, can you walk us through how you think the pace of discussions with distributors plays out over the next few quarters? Will those be complete near term as the synergies build towards your estimates, kind of spike in terms of the impact or would it likely build over a number of quarters as you go through those discussions?.
Yes. No problem, Steve. I think it's going to take us about six quarters to go through. It's something that we did begin and we called out in Q4. We started around December to look at this. And listen, there are several things you want to do. There are some countries that we may not want to be in for several reasons, be that size, profitability.
There is others where we'd be willing to partner up with them, but we tend to look more for exclusive deals. And, as you know, you're going back and forth with third parties, that takes a while to get through.
So, our thought in our model having started in December, you should see some of that action occur as we start getting deeper into Q2, be bigger in the Q3. But it is going to be something that we carry out probably well into 2018 before we think we're at the finish point with the non-Japan markets..
Okay. Got it. And then, Dave, you mentioned beginning the sales force build on trauma.
Have you begun recruiting the field sales force or is it more leadership at this stage? And how should we think about the build out there and how bigger the group you're expecting to get here maybe by the end of the year?.
We've begun with the senior leadership at this point. During this quarter, we will start to recruit and hire some of the field sales folks, and down to the rep level probably in the third quarter. And I don't think we have shared any numbers in terms of where – what that initial build is going to be, as is our practice in all of businesses..
Okay.
But starting – I'm sorry, in the second quarter, you start building the sales force?.
There'll be a -- the field sales management will be onboarded in the second quarter, so you'll see a heavier spend there in the second and third quarters as we build up that team..
Okay. Got it. Thanks, Dave Demski..
Yes..
And this does conclude today's conference call. Thank you for your participation. You may now disconnect..