Stryker Corporation

Welcome to the first quarter 2019 Striker earnings call. My name is Jesse and I'll be your operator for today's call. At this time, all participants are in a listen only mode. Following the conference, we'll conduct a question and answer session. During that time, participants will have the opportunity to ask one question and one follow up question. If you'd like to ask a question, please press star one. This conference call is being recorded for replay purposes. Before you begin, I would like to remind you that the discussions during the conference call today will include forward-looking statements. Factors that could cause actual results to differ materially are discussed in the company's most recent filings with the SEC. Also, the discussions will include certain non-GAAP financial measures. Reconciliation to the most directly comparable GAAP financial measures can be found in today's press release. This is an exhibit to Striker's current report on form 8K filed today with SEC. I will now turn the call over to Mr. Kevin Lobo, Chairman and Chief Executive Officer. You may proceed,

sir. Welcome to Striker's first quarter earnings call. Joining me today are Glenn Bainline, Striker CFO, and Catherine Owen, Vice President of Strategy and Investor Relations. For today's call, I'll provide opening comments, followed by Catherine, with updates on MAKO and K2M. Glenn will then provide additional details regarding our quarterly results before we open the call to Q&A. Following an excellent 2018, our Q&A results reflect continued momentum across our three segments, with over 7% organic sales growth. This growth was balanced between US and international at roughly 7% each, with particularly robust gains in emerging markets and Europe. By segment, MedSurg led the way with 9% worldwide organic growth, driven by impressive mid-teens organic growth at instruments. Orthopedics grew 5% globally, with knees growing 7% behind MAKO, and hips gaining 4%, benefiting from the recent 3D-printed acetabular cup launch. Neurotech and spine had worldwide organic growth of 8%, as neurotech's double-digit growth, powered by neurovascular, was offset by low single-digit spine growth. Turning to the P&L, adjusted operating margin improved by 10 basis points, despite absorbing significant steel-related dilution. With the strong top line and continued progress with our cost transformation for growth initiatives, we remain on track to achieve our full year target of 30 to 50 basis points of operating margin expansion. We continue to effectively integrate acquisitions, and also make meaningful investments in R&D, which ensures a steady cadence of new product introductions, such as Endoscopy's recently launched 1688 camera. Overall, driven by the sales growth at the high end of medtech, we achieved adjusted per share earnings of $1.88, up 12%. Looking ahead to the full year, we are confident in sustaining this momentum, and in our ability to deliver on our commitments to our customers, employees, and shareholders. This is reflected in our adjusted guidance, which raises the bottom end of both our full year organic sales growth and adjusted EPS ranges. With that, I will now turn the call over to Catherine.

Thanks, Kevin. Starting with MAKO, we installed a total of 35 robots globally in the quarter, with 27 in the US. By comparison, in the comparable quarter a year ago, we installed a total of 28 robots, of which 24 were in the US. Globally, our installed base of robots is approaching 700, with over 550 in the US. Looking at US procedures in Q1, MAKO total need procedures exceeded 15,000, increasing over 80% from the prior year quarter, while total MAKO procedures approximated 24,000. These results indicate we are continuing to build on the momentum we saw in 2018, where total MAKO need procedures for the year topped 45,000. With a continued healthy order book, we anticipate strong robot sales in 2019, as hospital and surgeon interest in robotic programs for orthopedics continues to increase. We also expect to continue to build on the clinical data that demonstrates the unique benefits of the MAKO technology. Turning to K2M, we are pleased with the continued progress on the integration front. With the organizational structure in place, we are building inventory to help support cross-training for our combined selling organization. On a combined constant currency basis, our sales grew 2% in the quarter, and we anticipate a continued sequential ramp in sales for the full year, and we are on track to achieve combined fine sales growth in the mid-single digits for 2019. With that, I'll now turn the call over to Glenn.

Thanks, Catherine. Today I will focus my comments on our first quarter financial results and the related drivers. Our detailed financial results have been provided in today's press release. Our organic sales growth was .3% in the quarter. As a reminder, this quarter included the same number of selling days as Q1 2018. Pricing in the quarter was unfavorable .4% from the prior quarter, while foreign currency had an unfavorable .1% impact on sales. For the quarter, U.S. sales continued to demonstrate strong momentum with organic growth of 7.4%, reflecting solid performances across our portfolio. International sales grew .9% organically, which was balanced across the regions. Our adjusted quarterly EPS of $1.88 increased .9% from the prior year, reflecting strong drop through on sales growth, combined with good operating expense control and some favorability on our quarterly effective tax rate. Our first quarter EPS included an approximate five cent negative impact from exchange rates, including translational and transactional. This is versus a two to four cents that we had anticipated at the start of the quarter. Now we'll provide some highlights around our segment performance. Orthopedics delivered constant currency growth of .1% and organic growth of 5%. U.S. organic growth of .4% is highlighted by knees, which grew .6% and mid-teen growth of orthopedic capital. This was offset by anticipated decline in bone cement related to the continued growth in cementless and the timing of bulk orders. Within the knee segment, we continue to see strong demand for our Mako TKA platform, our cementless knee and other 3D printed products. U.S. trauma grew 3% against tough comparisons and was impacted by a delay in the full commercial launch of T2 alpha, which has been pushed back to mid-year. Internationally, orthopedics delivered organic growth of 6.4%, which reflects solid performances in Europe, Australia and emerging markets, with particularly strong growth in China. MedSurg continue to have strong growth across all businesses in the quarter, with constant currency growth of 10% and organic gains of 8.9%, which included a .6% increase in the U.S. Instruments had U.S. organic growth of 17.5%, led by impressive gains across its power tool and waste management products. Endoscopy delivered U.S. organic growth of 7.5%. Endoscopy had strong performances across its Novodak, sports medicine, communications and pro-care businesses. Late in the quarter, Endoscopy launched its new 1688 video platform and began to ship initial units. The medical division had U.S. organic growth of 9.2%, reflecting solid performance in its bed, stretcher and sage businesses. Internationally, MedSurg had organic growth of 2.7%, with strong performance in China and other emerging markets, partially offset by softer performance in Japan and Australia. Neurotechnology and spine had constant currency growth of 23.2%, driven by our K2M acquisition, and organic growth of 7.8%. This growth reflects good performance within our neurotech product lines, including high team growth performance of our neurovascular business. Our U.S. neurotech business had organic growth of .3% for the quarter, highlighted by strong double-digit growth of our neurovascular business, offset by expected softness in neuro-powered instruments ahead of the planned Sonopet IQ launch. Underlying the overall growth, though, we continue to see strong demand for our hemorrhagic, ischemic stroke and CMF products. We made significant progress in our integration of K2M, especially on the execution of our planned cost synergies. Our sales integration is ongoing, and we continue to manage through the anticipated sales force disruption, which primarily impacted our U.S. growth. Internationally, neurotechnology and spine had organic growth of 14.3%. This performance was driven by continued strong demand in Europe, China, and other emerging markets. Now I will focus on the operating highlights in the first quarter. Our adjusted gross margin of .8% was unfavorable 50 basis points from the prior quarter. Compared to the prior quarter, gross margin expansion was favorably impacted by acquisitions, but offset by price and business mix. R&D spending was .2% of sales. Our adjusted SG&A was .5% of sales, which was favorable to the prior quarter by 50 basis points. This reflects the continued focus on operating expense improvements through our Cost Transformation for Growth, CTG program, including key projects focused on indirect purchasing and shared services. This is offset by negative impact of acquisitions and continued planned investments in other CTG programs, like our ERP project, which has been expanded in scope given our acquisition activity. In summary for the quarter, our adjusted operating margin was .1% of sales, which was approximately 10 basis points favorable to the prior year quarter. Our operating margin primarily reflects good leverage and continued operational savings, offset by investments and acquisitions, the latter of which had an approximately 50 basis points negative impact on the quarter. Next, I will provide some highlights on other income and expense. Other expenses decreased from prior year quarter, primarily due to favorable interest rates and other income. Our first quarter adjusted effective tax rate was 14.4%, which primarily reflects the benefit related to stock compensation expenses. As a reminder, we are still forecasting a full year effective tax rate between 16 and 17%. Focusing on the balance sheet, we continue to maintain a strong position with 1.8 billion of cash and marketable securities, of which 45% was held outside the US. Total debt on the balance sheet was 8.5 billion. Turning to cash flow, our year to date cash from operations was approximately 313 million. This reflects the net impact from increased adjusted earnings, certain acquisition and integration charges related to K-2M, and the receipt of a legal settlement payment. In January 2019, we repurchased approximately 1.9 million shares, or 307 million. And now I will discuss our second quarter guidance. As a reminder, Q2 and Q4 have the same number of selling days as 2018, while Q3 has one more selling day. Given our first quarter performance and continued momentum, we now expect organic sales growth to be in the range of .8% to .5% for 2019. If foreign currency exchange rates hold near current levels, we expect net sales in the second quarter will be negatively impacted by approximately 1.5%, and the full year will be negatively impacted by approximately 1%. Net earnings per diluted share will be negatively impacted by one to three cents in the second quarter, and negatively impacted by five to 10 cents in the full year. We also now believe our adjusted net earnings per diluted share will be in the range of 805 to 820 for the full year. For the second quarter, we anticipated adjusted net earnings per diluted share to be in the range of $1.90 to $1.95. This guidance, full year and second quarter, include the anticipated impacts from acquisition dilution and the net foreign currency exchange, including both translational and transactional impacts. And now I will open up the call for Q&A.

Thank you. We will now begin the question and answer session. If you have a question, please press star one. If you wish to remove from the queue, please press the pound key. As a reminder, callers are limited to one question and one follow-up question. Your first question comes from a line of Bob Hopkins with Bank of America. You may proceed.

Oh, great. Thank you very much for taking the questions. I guess to start out, congrats on a really strong quarter. Two things stuck out to me. One, I wanted to get a little bit better sense for your commentary on Europe and emerging markets. Is that strong strike or performance? Is that strong market or is that kind of both? Thank you for the first question.

So I would say, Bob, that it's really our efforts. As you know, we are under-penetrated in these markets versus the competition, and as we've been upgrading our talent and changed our commercial offense in Europe, and I think it's primarily our efforts, market conditions in Europe continue to be pretty challenged. But we had a particularly strong quarter. We did benefit from the comparison in the prior year. If you remember, the UK had bed blockages, so we didn't have that comparison this year. And in emerging markets, it's really, we've been getting our offense rolling. Last year, we had double-digit growth, and we had strong double-digit growth this year in emerging markets. So I'd say it's more of a striker story, but that's really due to our relative position versus others.

Okay, and then for the follow-up, I was just wondering if you could talk a little bit about the growth drivers over the course of the rest of this year. It sounds like the camera, obviously, was a little early for that to have any impact, but Endo had a good growth rate anyway, and now the camera should kick in for the rest of the year. But what are the things that we should be thinking about as we consider the rest of the year in terms of growth drivers? Obviously, from my vantage point, there's one big, obvious incremental positive, but what are the other things that we should be thinking about?

Yeah, Bob, as you mentioned, 1688, we did just start the commercial launch at the end of the quarter, and similar to prior camera launches, as you know, it's usually a couple of quarters before they really hit their stride. So I would think about that having a more meaningful contribution to Endo in the second half of the year. We also feel really good about the Mako order book, so we expect continued strong demand for the robot and continued strong utilization there, so that will be a driver. If you look across the portfolios, you know we're a lot of singles and doubles, I think we've got some product launches coming, like our next generation Sonopet, which will have an impact as you get, really kind of around mid-year, and then trauma was impacted by some delays tied to the full commercial release of T2, and so that's probably gonna be in the full commercial release mode around mid-year, so that will have more of an impact on trauma in the second half of the year. So that's just a few of the ones I would highlight.

Great,

thank you.

Your next call comes from the line of David Lewis with Morgan Stanley. Your line is open.

Good afternoon, just a couple questions for me. I thought, Kevin, if we could start just kind of post-AOS on the broader ortho market. I think everyone talked about ortho growth in 2018, and maybe the fourth quarter was not as strong as some had hoped. Your numbers first quarter seemed pretty in line. The Mako number was strong. I noticed the Mako procedure number was more flat as sequentially. I wondered you sort of talk about your thoughts on Mako procedure sequentially, the orthopedic market volume sort of first quarter versus expectations, and your outlook for these sort of businesses post-AOS.

Yeah, I'll take the Mako part first, and I think you've got to keep in mind the cadence of procedure volumes when you go from Q4, which is always the strongest quarterly, number four recon into Q1. So we always have fewer volume of procedures in the first quarter, and also the Mako placement, which was very robust in the fourth quarter, don't factor in until we have them out for a full quarter. So it's just the normal cadence. We had roughly 30% -over-year growth in the utilization rates for the robot. We had really healthy procedure growth of around 80% -over-year. So I'd focus less on sequential and more -over-year unless you're gonna adjust for just the variance and sequential patterns. We feel great about what we're seeing with Mako, the order book, the demand for new robots. So nothing I'd read into beyond just normal quarterly variance.

And on your second question about the orthopedic market, last year was a slow market in general, and we had indicated that we thought this year would be slightly better. And I would say at this stage of the year, we do believe that the market will be slightly better in 19 than it was in 18.

Okay, very helpful. And then Kevin, just focusing on the key upside driver in the quarter, obviously was MedSurg. Bob obviously talked about the camera, which will start contributing into the back half of the year. But obviously in recent weeks, there's been a lot of concern about Medicare for all and the impact it would have on capital providers. You just spend a moment talking really two things. How this business has transitioned in the last four to five years from a durability perspective. And as you think about the balance of the year and the ability to deliver strong MedSurg numbers in the order book, how you're feeling about the balance of the year? Thanks so much.

Yeah, David, I would say there's really no change. If you go back to our analyst meeting that we had back in November, I said I expected 2019 to be every bit as good as 2018 or a very similar year. And at this stage of 2019, that holds. And that's really across our businesses. As you've seen since the beginning of 18, we've had very good balance, both across our businesses and across our geographies, which is different than the story we had four or five years ago. So I feel like all our businesses are in healthy position. We have, as you know, a number of new products that the timing of which vary from business to business, but feel very good about the durability of our sales performance.

Your next call comes from the line of Vijay Kumar with Evercore IC. You may proceed.

Hey, guys. Thanks for taking my question. So maybe I'll start with, you know, Make-O. You know, Kevin, there was some concern on, you know, competitive entry. It looks like numbers are really strong. I'm just curious on how you see the market evolving with the new player. Is this a case where the market is accelerating and both players benefit, or any thoughts on the competitive landscape, I think, would be a helpful source for starting points.

Yeah, thanks for the question. I think, first of all, keep in mind that penetration rates in our own business are still very low. So there's a lot of opportunity here for growth in robotics. And so we believe the competition is going to do what it typically does in most markets. It's going to raise awareness and interest and help to grow the overall space. You know, clearly, we're the leader here. We've got robust features, including haptics and the ability to do multiple joint procedures. So we expect our momentum to continue. We're seeing a ramp up in our customers' hospitals with multiple MAKOs, as well as new installs into hospitals. So given where penetration rates are and given the unique features and benefits and mounting clinical data in support of our robot, we feel really bullish about the outlook.

And as Catherine said in her opening comments, the order book continues to be strong. So we expect another strong year for MAKO in 2019.

That's helpful. And one quick one for Glen on the guidance comments here. It looks like FX worsened for you guys, but yet you raised the low end of the guidance. It looks like the underlying operating margin execution is coming in really well, despite the increased investments that you spoke about. Maybe just comment on margins and what gives you the confidence here, just given the amount of deals you guys have done. Thank you.

Yeah, first off, I guess I would say on the FX issue, you know, you're right. It came in a little bit less favorably than we thought for first quarter. But looking at what happened to rates last year and where we think rates strengthened in the second half of last year, I think that we'll still stay within our zero to 10 cent range for the full year impact. It'll just, the impact will be more pronounced early on in the year and less so in the latter half of the year. In terms of off margin, you know, a couple things that, you know, Catherine just highlighted, first of all, a lot of really robust new product launches that we'll have. That mix will come into play later on in the year. I think in Q2, you're still gonna feel the impact from K2 as we're still working through sales integration in the second quarter. So we'll still have a little bit of heavy dilution coming in from K2 and for Q2. And then I think what you'll see beyond that is we'll start to see sales expansion on the new products. We'll also see, you know, continued improvement in our shared service efforts, continued ramping of our indirect spend efforts, and that'll start to offset some of these other things. So I really do still remain very confident in our ability to hit 30 or 50 basis points expansion.

Your next call comes from the line of Richard Newiter with SVB Lerink. You may proceed.

Hi, thanks for taking the questions. I just wanted to start, I'm sorry if I missed it in the opening comments, but can you characterize just how the K2 integration efforts are going relative to, you know, your initial expectations? And when do you think we'll see kind of the true synergies kind of playing out from that deal?

Yeah, I would say it's very much tracking as we anticipated. We closed late in the quarter, and as I mentioned on the call, we feel really good about it. We're doing really good with the progress, the organizational structures and playlists. We're building inventory to help support cross-training for the combined selling organization. There's no change to our target of -single-digit combined growth for the full year. So everything is going as expected. We expected sales to synergies and higher dilution in the early part, as you would assume, and then we expect to see a continued sequential ramp in revenues the year unfold. So really nothing different than that. Kevin,

just... Go ahead. Yeah, Kevin, just going back to David's question on the underlying ortho and e-market growth rates. You know, it's encouraging to see that you feel confident that, you know, compared to last year, a slight step up in market rates. But I guess my question here is just, you know, one cue, I appreciate seasonality. The volumes are a little bit later than what they are in the season-stronger four cue, but you need growth rates, you know, to, you know, are kind of slattish, even on a comp-adjusted basis. I mean, what more can you give that you're seeing in the marketplace that continues to give you confidence that there's that step up in growth for the year?

Yeah, I just think last year was a bit of an anomaly. It was the lowest growth in the market that we've seen since 2011, and we don't see anything underlying in terms of demand and hospital dynamics that would cause that to be a situation that would continue. So I just think you get one of those kind of years every seven or eight years, it's unlikely that that would continue. So I just think the underlying conditions in the market are good. We can see with Mako that there's huge interest in continuing to advance the robotic offerings in NEES in particular. So it's just one of those, it's a feeling, right? I don't have a crystal ball, but it's just based on what we're seeing and what we're hearing in the marketplace. I think that right now, our intent at the beginning of the year, we said we believe it'll be a better year. There's nothing I've seen that leads me to believe it won't be. But I'm not expecting, you know, it's not gonna double or triple. It'll be a modest improvement in 2019.

Your next call comes from the line of Kristen Stewart with Barclays. You may proceed.

Hi, I was just wondering in terms of the growth margin, if you can maybe help us parse out how much of it was just kind of a mix effect versus anything else?

Yeah, Kristen, I can give you sort of directionally what we felt. You know, we've gotten away from guiding on gross margin and really focused on off margin. But, you know, for the quarter, we definitely, first of all, had some positive effect coming from adding in K2, because K2 has very strong margins. But really offsetting that were some of the big negatives, especially price brought that down. And then secondly, just mix. You know, if you look at sort of the growth rates of orthopedics versus the growth rates of medsurg, you really are gonna have sort of skewing to sort of lower gross margins, because that's the way the capital business is performed.

That's helpful. And then just in terms of the tax guidance, I think you said you reiterated the 16 to 17. Do you feel like the lower end might be a little bit more likely, just given the performance in one queue?

Yeah, I mean, keep in mind, usually, the cadence of how the effective tax rate plays out is it's usually lower in the first quarter. We have a lot of stock comp that flows through the first quarter. And the other thing that hit us in this quarter was maybe a higher expected stock price than we had planned on initially. But, you know, based on our forecasting, I'm still angling sort of to the midpoint, between 16 and 17% for the full year.

Your next call comes from Robbie Marcus with JP Morgan. You may proceed.

Great, thanks for taking the question. Congrats on a good quarter. Glen, can you give us sort of your latest thoughts here on capital allocation? Maybe first, how free cash flow is trending and how we should think about that this year. And then maybe as we sit here, a good chunk of the way into the integrations of your acquisitions, how you're thinking about further M&A and how you see the universe out there right now? Sure.

I think, first of all, as we reiterated several times, we really have not changed our capital allocation strategy. The bulk of our cash will go towards M&A. And then we'll have cash that we'll use for dividend expansion. And then lastly, for share repurchases. You know, this year we've completed our share repurchases and really just purchased enough to offset dilution. I think moving over to cash flow, keep in mind that first quarter is always seasonally sort of the lowest relative to our cash flow performance. If you look at this year, we owe versus 2018. We had a lot more integration spending than we normally have because of the timing of K2. I think offsetting that, we did get a legal settlement that came in. And then beyond that, I think if you just look at sort of working capital performance, as Katherine had mentioned with K2, but also with other acquisitions, we'll continue to expand inventory as we ramp up those acquired businesses. And so working capital will perform a little more negative early on in the year. In terms of guidance, we are not backing away from our free cash flow performance in the range of 70 to 80% of adjusted net earnings. That's what we're targeting. And the whole business is lined up behind that.

Great, and maybe just one quick follow-up on the neurovascular business, another nice quarter there, double digit growth. Can you just give us the latest status of your product launches? I know you have a number of them coming over the course of this year. Just give us the latest on where you stand and when we should start to see that throughout 2019.

Thanks. Yeah, we're continuing to be pleased with the performance on both the hemorrhagic and ischemic side, and particularly with ischemic market expansion, likely to continue based on just the really compelling clinical data. For a flow diverting stent, Surpass, we're excited about that. But as we've said before, for both aspiration, those are gonna be slow launches and really ramp up into the year. It's an exciting opportunity, but you've also got established competitors there. So I think it'll be a bigger driver of growth for that as we head into 2020.

Your next call comes from the line of Larry Bielson with Wells Fargo. You may proceed.

This is Shagun in for Larry. Thank you for taking the question. So Striker recently acquired ortho space and a US clinical study is underway. According to clinicaltrials.gov, the study completion date is April 2019. I was just wondering if you've seen the pivotal data yet. What are your latest thoughts on the opportunity? Is a US launch likely in 2020? And then I have a follow-up.

Yeah, no, we have not seen the pivotal data yet. I'm not sure about the April 2019 date. We'll have to get back to you on that. We don't have plans to launch ortho space this year. I can't really comment on when that'll be. We'll probably do that on the next earnings call, but we are very pleased with the data. OUS is really, really compelling. Surgeon feedback is outstanding. It solves a huge unmet need. Of large rotator cuff repairs, which today are not treatable. So we're really excited about the future prospects, but in terms of timing for US launch, that's something we'll get back to on the next quarters call.

Got it. And then just as a follow-up, Kevin, I was hoping to get your comments here. Some companies have indicated that the FDA is becoming more conservative with respect to product approvals, product classifications, and as well as post-market surveillance. As the CEO of Striker and the new head of AdvoMed, what are you seeing on your end and what is your sense of FDA's direction going forward? Thank you.

Yeah, I know. So for the Striker portfolio products, we're not really seeing much of a change. I think we have seen a couple of decisions recently, whether it's related to Paxitaxel or more recently related to the slings, the vaginal mesh products. We've seen some decisions that the FDA has made, which might be deemed a little bit abrupt, but overall, our relationship, industry with FDA has been very good and frankly has improved pretty measurably from five years ago. I think our user fee agreements that we've had with the FDA have been terrific, and frankly, most of the companies we talk to have more issues with CMS than they do with FDA. So I don't think there's a big change going on in FDA. There's been a couple of recent decisions that were maybe a little bit more abrupt than what we were used to, but overall, I would say, I would characterize the relationship between Stryker and the FDA and the AdventMed more broadly and the FDA as a very healthy relationship. Keep in mind that Jeff Schurren, who's the head of CDRH, is still in his role, and we're very pleased with the progress he's made with the device group and have a good relationship with him. In spite of the change of the commissioner, there hasn't been a change in terms of the CDRH branch. So I would say things are very good still with the FDA.

Your next call comes from the line of Chris Pasquale with Guggenheim. Please proceed.

Instruments was strong again this quarter. Can you just talk a little bit about what you're seeing in that business? The comps get a lot tougher starting in two cues. So how do you think about the growth potential of that segment going forward?

Thanks, Chris. No, you're correct. It was a really strong quarter. Candidly, it came in better than we expected. We did split the sales force at the start of the year, and that really helped bolster the revenue. You often see that when you split the sales force in the initial months. I do think you need to be cognizant of comparisons and the fact that I wouldn't necessarily extrapolate just how strong the first quarter results were as you do your modeling for the remainder of the year. Still have very healthy growth, but this was a particularly robust quarter.

Okay. And then just on the trauma business, you mentioned the T2 alpha launch had been delayed. Just what happened there? And absent the impact of that, what are you seeing in those end markets in trauma and extremities?

That was really the biggest factor for us. Look, we target a launch timing, and sometimes it comes in earlier than expected, as the case was with our 1688 camera, and sometimes they get pushed out a few months or a couple quarters. You're trying to thread a needle pretty tightly here, so just working through some final issues as we get ready to launch it. We do expect a pretty big impact, but it's probably, it's in limited release. We're probably looking at full commercial release more like mid-year. That was the biggest factor in the quarter.

Your next call comes from the line of Tito Checkering with Deutsche Bank. You may proceed.

Hi guys, thanks for taking my questions. Two questions for you on MAKO. I do understand that the order book remains robust at this point, but has the MAKO sales cycle lengthened since the launch of the ROSA? In the second one, you previously disclosed that 40, 50% of MAKO robot sales are in competitive counts. Has that changed at all, again, since the launch of the ROSA?

So we haven't seen any difference or any change in time in terms of the order cycle for MAKO, and we are continuing to see significant placement. It was about 55% in the quarter went into competitive accounts where we either have no market share or very little market share. I will note, though, that going forward, we will no longer be providing that level of detail. We'll continue to give you robot sales, both US and globally. We'll continue to give you MAKO procedures so you can track the growth there, and we'll continue to give you a clean-knee number that allows you to accurately track knee implant growth and market share gains. But beyond that, the detail we gave previously was really intended in the early days of the initial launch to validate the acquisition and the strength of the technology. We're coming up on three years from the limited launch, so we think we've established the success of MAKO with 700 robots out there. So we think limiting it really for competitive reasons to total robot sales procedures and knee revenue is what we're going to be doing going forward. But for the quarter, yes, we continue to see strong placements and competitive accounts at north of 50%.

And no slowdown. Perfect. One question on guidance. How much of the 30, 50 basis points of operating margin improvement you got in 2019 comes in the product mix?

Yeah, you know, we're not going to guide that specifically. I mean, I will say, you know, when we looked at gross margin performance, you know, because MedSurg and neurotechnology are just growing faster, we'll see sort of moderating of gross margin. But beyond that, I'm not going to comment on sort of the mix within the gross margin.

Your next call comes from the line of Craig Bijou with Cantor Fitzgerald. You may proceed.

Great. Thanks for taking the questions. Maybe, Kevin, I wanted to start with the foot and ankle business. I wanted to see if you could parse that out. And I think on the Q4 or parse out the growth for this quarter. And I think on the Q4 call, you said that growth was trending, you know, maybe more in line with the market. So kind of wanted to get your updated thoughts there and what you guys are doing to, you know, is that how we should think about that business going forward, kind of in line with the market? Or will there be innovation, new products that is going to accelerate that over the next couple of years?

Yeah, no, we love our foot and ankle business. As you know, we've become sort of the market leader on a par with Wright Medical from a position five or six years ago where we really had a very, very small place in the market. And so we expect to continue to grow well. We do have a number of small innovations within foot and ankle that we'll be launching this year just to round out our portfolio. And we expect to continue to grow really in line with market, potentially above market. We're the first to report, so it'll be... People have to wait to see how everybody else comes in. But it continues to be a strong grower for us within trauma. It obviously grows faster than the overall trauma and extremities business. And that was true, again, in the first quarter.

Great. That's helpful. And as a follow-up, just on cementless knees, another metric that you guys have provided before, wanted to see if you're still willing to provide the percentage of your knees that were cementless. And then any updated thoughts after AOS going forward where that percentage can land?

Yeah, so it continues to climb. And that's part of the reason why, if you look at our other ortho number, which includes robot sales and bone cement, declines in our bone cement revenue. And that was one of the contributing factors. It continues to ramp into the 30%. It was up sequentially and up year over year in terms of the penetration. We probably have a lot of runway. I don't think it's going to get to the level that you see with HIPs, but certainly we're expecting it to continue to climb.

Your next call comes from the line of Matt Taylor with UBS. You may proceed.

Thanks for taking the question. So the first one I wanted to ask was just about some of the leading indicators that you're looking at that give you the confidence in raising the lower end for the year. You talked about the order book. Last time you gave a lot of detail on that across different businesses. I was wondering if you could expand on that comment at all, or anything else that you're seeing in the market that gives you good visibility that will see sustained growth through the year.

Yeah, so a lot of the momentum that we had last year is continuing into this year. Keep in mind, we started the year with the highest organic revenue guide that we've had in over a decade, at 6.5 to 7.5. And despite some difficult comps, we came in this quarter at 7.3 organic growth. We have a number of businesses with healthy order books, and it's across the capital businesses. Obviously, Endo's big capital with 1688 rollout. We'll have a big impact in the back half of the year. And we're seeing great momentum across Endo with Novodak as well. And Mako momentum is continuing. So it's really across the portfolio. When you're as big and diversified as us, there's always some challenges. As we noted, trauma, the full commercial launch of T2 is going to be closer to mid-year. But across the board, starting the year at 7.3 and the visibility we have across the businesses and product launches is really what drove us to have the comfort level in raising or tightening the range towards the higher end.

Thanks. And just to follow up on the environment, I was wondering if you could comment if you've seen anything notable in terms of changes in customer behavior, whether it's on the pricing side or in the market dynamics around insurance approvals or pushback?

No, like literally nothing. No changes whatsoever.

Your next call comes from William Inglis with Piper Jaffrey. You may proceed.

Great. Thanks for taking the questions. Building off the previous ortho space question, your sports med franchise has been one of your quieter growth drivers, I believe, and you called out your domestic share position as number three at your recent analyst day. Just curious if you have any sense of when you could be number two. And if there are any particular launches beyond the 1688, we should be thinking about this year as meaningful growth drivers or if it's just a culmination of singles.

Yeah, so as you know, our sports medicine business has had very strong double digit growth for a number of years as we've built out our implant portfolio, both internally developed as well as acquired through a number of smaller acquisitions. We're actually the market leader in hip arthroscopy on the heels of our pivot acquisition, as well as the pivot garden table, which we launched internally. And we still have room to grow in both knee and shoulder. We have a couple of shoulder product launches planned for this year that will bolster that part of the portfolio. So I expect continued strong double digit growth out of sports medicine. It did have a very strong first quarter. We still have a runway to go. And we're very pleased, though, to now be one of the leaders in sports medicine, which clearly wasn't the case years ago. And continue to look for acquisitions. There aren't as many sort of mid to larger sized companies. So we tend to have to pick off small companies like you saw with ortho space, but still plenty of room for innovation. And we're excited about building our strength more in the knee and the shoulder. And the shoulder this year is a big priority with a number of new product launches.

Great, thanks for that. And then just a general question on the ischemic stroke market. The early adopters of the expanded treatment window were certainly a nice growth driver. Curious what inning you think we're in in terms of patients having access and benefiting from the DAUN guidelines and the cadence of patients being funneled to comprehensive stroke centers?

Yeah, we're in the early stages there. This is a market that you're going to see swings in market growth quarter to quarter, whether it's on new clinical data that comes out or infrastructure build. There's a lot of work that needs to be done to be able to get patients to the right comprehensive stroke center for the right treatment. So that's market development that we, along with others in this market, are doing together. But I think you're in the early innings in terms of the overall opportunity for ischemic stroke device-based treatments.

Your next call comes from Larry Koesch with Raymond James. You may proceed.

Oh, thanks. Two questions. Number one, I was just hoping you might be able to give us a little bit of flavor on the capital environment, in particular in medical. That was obviously strong. So just any thoughts on sort of the backdrop there?

Yeah, the overall capital environment, whether it's medical or other capital businesses, continues to be favorable. I wouldn't say we've seen a big change from what we saw in 2018. It's healthy. But capital varies. We have strong product cycles across a number of our businesses that have capital offerings. And so some of it is specific to Stryker and against the backdrop of an overall stable hospital capex environment.

OK, perfect. And then, Kevin, you sit in a unique position in the sense that you're CEO of a very large medical device company. You're also highly involved in the admin and the leadership there. So I was wondering if you might provide just some thoughts on what do you think is the reality or viability of a single payer system in the US?

Yeah, at this point in the political cycle, any comment would be purely speculative. I personally view the likelihood of Medicare for all as highly improbable.

Your next call comes from Matt Mixick with Credit Suisse. You may proceed.

Hey, guys. This is Vickin from Matt. Can you hear me OK?

Yes, we can.

Hi. So just two questions. First, thanks for the helpful color on volumes and on volumes and utilization for MAKO. And just given how these trends are going, we were hoping you could help us out and talk a little bit about the potential capacity and throughput of your current install base, kind of where you think you are now, what you think that looks like over time, and any color you could offer on how long it takes for an average to reach some of those levels and how to follow up after that.

So that's a really difficult question to give you some real analytics around that. It varies based on the surgeon. It varies based on their volume. It varies based on the size of the physician group. And generally, though, once you're trained and you don't come back into practice and start doing 100% of your knees or hips on MAKO, you gradually ramp up as you get more comfortable with the technology. And we can see that can be anywhere from 12 months or so. But again, that's an average for something that varies considerably. We do pay a lot of attention to the utilization rate. And this is why it's so important that when we place a robot, there's a surgeon champion. And oftentimes, that surgeon champion grows as other surgeons get exposure to the MAKO robot. And as I mentioned on the call, we continue to see strong growth year over year in utilization rates. It's been increasing every quarter. It was up 30% year over year this quarter. And as we get more robots in the install base, we expect that to continue to grow. How big it eventually gets, that's difficult to say. But we do believe we have ample runway to continue to take market share for years.

And what I would say is that when they do reach capacity, there always is the option of buying a second robot. And as we mentioned previously, about 10% of the hospitals where we have a robot have a second robot and maybe a third robot. We have some systems, a very, very large system that has four or five robots. So the ability to sell additional robots when the capacity is reached is something that we can certainly continue to do.

Gara, that's very helpful. And just one follow up on endoscopy and the potential impact of the 1688 camera. Wondering if you could just kind of talk about any thoughts you have on driving further into the consumable space for some of these end markets like sports, medicine, or general surgery. Thank you.

So for the camera, we feel really good about the impact as we roll that out. And if you look at prior launches, 1588, 1488, you see a very similar trend. Momentum builds in the first year, particularly in the second half of the year. And it's really starting to hit its stride in the second full year of the launch. And we would expect something very similar here. And also helped by the Novodak acquisition where we continue to see really strong momentum. And we've become a bigger player in sports medicine. There's still a lot of room to go before we're a category leader. But we've brought innovative technologies in there and continue to see the benefit to the overall endo business from sports medicine.

Yeah, and we had the 1688 on display at the SAGES conference and received terrific surgeon feedback. The overlay of fluorescence imaging is really incredible. It's just a beautiful picture. We also improved the backlighting. So that lends itself to better performance in ENT and sports medicine procedures, as well as having a 4K picture, as well as light source. So a lot of improvements in the 1688. We expect this to be a winner of a product launch. Just as you saw with 1588, we had terrific growth, as Catherine mentioned. Sort of picks up in the second year. But I would expect a strong second half of the year for endoscopy. And frankly, we were very pleased with the first quarter, given 1588 was sort of towards the end of its cycle. We had really strong performance in sports, strong performance in communications, and strong performance with Novodak. So we have a really great leadership team at Stryker Endoscopy, and I expect continued strong performance there.

Your next call comes from the line of Kyle Rose with Canaccordi Nuiti. You may proceed.

Great. Thank you very much for taking the question. We touched on the extremities business with respect to trauma and then on the sports side. I wondered if you could just talk a little bit about the overall shoulder recon market. I think you have some new products that are launching over the course of the next 12 months. Just kind of how you think about that market.

Yeah, it's a good market, and we've been a very small player, -10% market share player in shoulder. I've been playing catch-up on our product portfolio. We have a total shoulder. We have a reverse shoulder. We have a fracture system, and we're launching the short stem really right now in the second quarter on a limited basis to have a bit more of an impact later. We still don't have a stemless shoulder that's in our pipeline. So we've been progressively adding to our portfolio. Our shoulder is growing well, but from admittedly a smaller base. But we do like the shoulder market, and we now have a competitive product offering to start to gain business. And we're pleased with the performance so far. We're excited about the short stem launch, and we'll see again more of that result in the second half, and you'll see in the first half.

And then coming out of AOS, obviously a big focus on robotics, but there was another focus specifically related to procedural trends in the outpatient setting. I just wanted to see, you obviously have a good viewpoint there given the product portfolio, but how do you view the outpatient market now? What really needs to happen to actually drive that as a catalyst to driving procedures there? And maybe some broader perspective would be helpful. Thank you.

Yeah, we've mentioned this before, that the trends towards outpatient will continue. I don't think there's any question about that over time. But until Medicare provides coverage in the outpatient setting, you're not going to see a big spike. They're covering it now in the hospital outpatient, but that's not the same thing as a surgery center. And so we haven't seen any signs of that happening, at least not in the near term. But once that happens, then I think that'll be the extra catalyst to drive a lot more volume. Right now there's a lot of talk about shifting inside of care, that the actual numbers are not that great at the current time. Clearly we're present in the surgery center with our sports medicine business, and we expect the procedures will continue to graduate towards the surgery center. But I think the timing is really uncertain, and for me the inflection point will be when we get Medicare coverage.

Your next call comes from Josh Jennings with Cohen. You may proceed.

Hi, Harris Sick Bull for Josh. I appreciate the question. So to start on M&A, spine is a market where historically you have lacked category leadership. And as you progress through kind of the early integration of K-2M, is this an asset that you believe can give you enough scale in the market over time, or do you see incremental M&A to kind of achieve that category leadership that Stryker typically aspires for?

Yes, so you can imagine that the organization is totally focused right now on ensuring the successful integration of K-2M. And we believe this is absolutely the portfolio, the offering, and the leadership team and the selling organization that can get us to category leadership. So we would expect to be in a position where we're taking market share. We've got that -single-digit target on a combined basis for this year, and we expect it to accelerate after that. So the timeframe to get to category leadership, it would be premature to state that, but we absolutely believe this is the portfolio that will get us there.

And what I would say is that every business of Stryker is on the hunt for new acquisitions. I think right now we're focused on integration, but at some point I would think that the spine business will have come forward with some types of acquisitions to bolster their portfolio. As you saw with ENT, we did Intellis, and then within one year of doing Intellis, we've done Aronex. So once we get into space, we're not going to do one deal and then stop. I can't expect that we'll do a spine deal in the next six months. We're going to be very busy with integration. But beyond that, if there's product holes in the portfolio that we'd like to fill in, every business of Stryker will constantly be looking at rounding out their portfolio, either internally developed or by acquisitions.

Okay, great. And then separately, can you remind us of the upcoming MAKO datasets you expect to publish in the near term, timing of that two-year dataset, and anything else worth highlighting?

Yes, so we're coming up on the three-year mark from the initial launch. And so we'd be hopeful. We'll be getting closer to having two-year follow-up data for the MAKO total knee, which is, you know, in the world of orthopedics and joint replacement is near-term data. The timing of that is tough to know. We have to hit the two-year mark. We have to crunch the data, and then you've got to submit it. So whether or not it's at AUKUS or AAOS or sometime in between, I don't know yet. But that's probably one of the next datasets that we would anticipate.

Your next call comes from Jeff Johnson with Barrett. You may proceed.

Thank you. Good afternoon. Just a couple of follow-up questions. Kevin, you mentioned Japan and Australia, some sluggishness there. Is that MAKRO or anything else to call out?

Yeah, they had some sluggishness with our capital equipment, and to us, that's just timing. We have very good businesses there that have been performing very well over a number of years. I expect that those businesses will pick back up for the remainder of the year, really capital timing-related. The ortho business is fine.

Okay, thank you. And then on China, it seems like stimulus efforts there might be helping MAKRO in China a little bit. Are you seeing that, or was the China strength you referenced more striker-related?

It's more striker-related just given how small we are. You know, we're far, far, far from the market leaders in China. And so whatever progress we make, we can make this kind of progress irrespective of any kind of stimulus efforts. It's just trying to gain our fair share of the business.

Your next call comes from Stephen Lichtman with Oppenheimer. You may proceed.

Thank you. Hi, guys. So obviously most of MAKRO placements continue to be in the U.S. Just wondering what you are seeing as potential for additional opportunities outside of the U.S., and what you think is right for expansion of MAKRO.

Yeah, we're really excited for the future about China and Japan. Those are going to be two very good markets. Today we only have approval for the hip in those markets. We need to get the knee approvals, which are pending right now. And then those will really take off as big, big markets. We built a training center in Hong Kong in the fourth quarter of last year, which we'll be using to train surgeons in those two markets. Those are really the, I'll call them the lagging markets. And even in India, we sold our first MAKRO recently in India. That could be a good market as well. But the big markets that are really untapped so far are China and Japan. And it's really been because of regulatory. It's just taking us longer to get MAKRO approved in those markets. But those will be great markets for the long term.

Got it. Thanks, Kevin. And then Glenn, I think you mentioned 50 basis points of headwind from acquisitions this past quarter. What are you looking for for the full year on that score? What's embedded within guidance for full year of headwind?

Yeah, we typically don't give out that number because there's lots of acquisitions that are still needing to be integrated. You know, what I will say is that, you know, over the past few years, it's been around 50 basis points for full year dilution. And my guess is based on the current set of acquisitions that we have right now in Q1, that we're trending very similar to that.

There are no further questions at this time. I will now turn the conference over to Mr. Kevin Lobo for any closing remarks.

Thank you for joining our call. As you can see, our momentum continues. And we look forward to sharing our Q2 results with you in July. Thank you.

Thank you, ladies and gentlemen. This concludes today's conference. Thank you for participating. You may now disconnect.