Earnings Labs

Hologic, Inc. (HOLX)

Q4 2016 Earnings Call· Wed, Nov 2, 2016

$76.01

+0.48%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

+5.15%

1 Week

+5.06%

1 Month

+8.88%

vs S&P

+3.51%

Transcript

Operator

Operator

Please standby. We're about to begin. Good afternoon and welcome to the Hologic Incorporated Fourth Quarter fiscal 2016 earnings conference call. My name is Kamille and I'm your operator for today's call. Today's conference call is being recorded. All lines have been placed on mute. I would now like to introduce Mike Watts, Vice President, Investor Relations and Corporate Communications to begin the call.

Michael J. Watts - Hologic, Inc.

Management

Thank you, Kamille. Good afternoon, everyone and thanks for joining us for Hologic's fourth quarter fiscal 2016 earnings call. With me today are Steve MacMillan, the Company's Chairman, President and CEO; and Bob McMahon, our Chief Financial Officer. Steve and Bob both have some prepared remarks today, then we'll have a question-and-answer session. Our fourth quarter press release is available now on the investor section of our website. We also will post our prepared remarks to our website shortly after we deliver them. Finally, a replay of this call will be archived on our website through November 25. Before we begin, I'd like to inform you that certain statements we make during this call will be forward-looking. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those expressed or implied. Such factors include those referenced in the Safe Harbor statement that's included in our earnings release, and in our filings with the SEC. Also during this call, we will be discussing certain non-GAAP financial measures. A reconciliation to GAAP financial measures can be found in our earnings release. Finally, any percentage changes that we discuss will be on a year-over-year basis, unless otherwise noted. Now I'd like to turn the call over to Steve MacMillan, Hologic's CEO.

Stephen P. MacMillan - Hologic, Inc.

Management

Thank you, Mike and good afternoon everyone. We're pleased to discuss Hologic's financial results for the fourth quarter of fiscal 2016. We once again posted strong results that illustrate the progress we're making toward building a sustainable growth company. In addition, our results capped off a very good fiscal 2016 in which we delivered on our commitments. Today, I'll first provide a high-level overview of our fourth quarter results. But since it's the end of our fiscal year, we'd also like to provide a strategic update on the journey we've shared over the last three years. We'll focus on our revenue and financial drivers for the full-year, and provide some color on the behind-the-scenes progress we're making in research and development. Let's start with our fourth quarter results. Revenue of $726.8 million grew 3.4% on a reported basis or 3.8% in constant currency; a healthy performance despite a difficult comparison to the prior-year period. We also absorbed a headwind of nearly $4 million from divested and discontinued products. Net of these, total revenues would have grown 4.4% in constant currency. Our Surgical business again set the pace with its seventh straight quarter of double-digit growth globally. We are also pleased with how our breast imaging and molecular diagnostics businesses performed, and encouraged that new products began to contribute to growth. We'll come back to this point in a minute. In terms of geography, U.S. sales grew 7.4% in the quarter, continuing a string of strong results. Even if we exclude the $5 million royalty payment from our fourth quarter results, our growth rate accelerated on a sequential basis. As expected, international sales declined 9.6% as reported or 7.8% in constant currency, versus a difficult comparison in the prior-year period. Apart from this tough comp, international Breast Health was stable sequentially…

Robert W. McMahon - Hologic, Inc.

Management

Thank you, Steve and good afternoon, everyone. I'm going to provide more detail on our divisional revenue performance, review the rest of our fourth-quarter financials, and then discuss our financial guidance for 2017. Unless otherwise noted, my commentary will focus on non-GAAP results, and revenue growth rates will be expressed in constant currency. We closed out our fiscal year with results that surpassed expectations. Revenue grew at a healthy rate, and favorable gross margins allowed us to reinvest opportunistically in the business, while still delivering strong bottom-line growth. I'll begin by discussing our Surgical division, which remained the growth leader in the quarter with sales of $101.5 million and growth of 17.6%. Fueling this growth was MyoSure, where sales of $42.6 million grew 33.4%, thanks to the outstanding efforts of our commercial team. In addition, NovaSure sales grew 8.7%, as we continued to gain market share and capitalize on a competitive withdrawal. Now moving to Diagnostics, we posted sales of $311.9 million in the quarter, a solid growth rate of 3.1%. In molecular diagnostics, quarterly sales of $134.3 million increased 9.6%. As Steve noted, we booked a $5 million royalty payment this quarter, but at the same time, we also absorbed a headwind of almost $3 million from our discontinued cystic fibrosis product line. So the underlying trends in the business remained strong, and we continue to gain share and increase utilization of women's health assays on the fully-automated Panther instrument. In addition, international sales grew at a mid-teens rate, and we posted yet another record quarter of Panther placements outside the U.S., providing a strong platform for future growth. Elsewhere in Diagnostics, our cytology and perinatal products posted sales of $121 million and increased slightly compared to the prior-year period. Share gains for our ThinPrep product continue to offset…

Operator

Operator

Our first question is from Brian Weinstein with William Blair. Brian D. Weinstein - William Blair & Co. LLC: Hey, guys. Thanks for taking the question and thanks for the good written guide. I have enough to worry about tonight like breaking that 108-year curse in a couple of hours, so I appreciate that.

Stephen P. MacMillan - Hologic, Inc.

Management

You're in first here, so you can get ready to focus on, Brian. Brian D. Weinstein - William Blair & Co. LLC: I appreciate that. Thank you very much. So, as we look at your guidance range, you had clearly signaled ahead of time that you were going to give a wider range and you certainly did that. I'm curious, you guided us to the midpoint but not on the high-end of the line there, is that really a function of kind of how you expect new products to contribute? You talked about $10 million from that this quarter and what not. But do you expect that new products are really the differentiating factor between that high-end to low-end and any color on that would be helpful. Thanks.

Stephen P. MacMillan - Hologic, Inc.

Management

Sure, Brian. The new products will certainly be a piece of it. I think we've all been around long enough to know no matter what we put into our forecast, it always comes out a little differently. And I just think it's a very prudent thing given particularly the environment to have a slightly broader range. I do think we see a little more – if the new products are doing well, which we fully expect they will, I think it clearly pushes us towards that higher end. I think we get into that 5%-ish range as things take off. We always want to be a little cautious until we start to see the success. I will tell you, I think Affirm is off to a very nice start. MyoSure REACH off to a very nice start. And these are really the first new products we've launched since we've come on. And also our international molecular diagnostics business is really starting to take off. We had a couple of quarters there of double-digit growth as well. So, there's a lot we feel good about, but again, still very early stages and a lot to play out.

Robert W. McMahon - Hologic, Inc.

Management

Yeah, I think the other thing, Brian, just to build on that is some of these products haven't gotten full approval yet as well. And so there is an estimate of timing to start with, but we certainly feel very good about our path there, but there is some flexibility there as well.

Stephen P. MacMillan - Hologic, Inc.

Management

Yeah. Brian D. Weinstein - William Blair & Co. LLC: And you mentioned OUS, specifically in molecular diagnostics. And I think you talked about a return to growth next year somewhere in, I think, maybe mid-single digits or something overall. But can you talk about some of the things more specifically OUS that you guys are focused on, some of the other products that you guys are focused on next year that potentially could add to growth there? Thanks.

Stephen P. MacMillan - Hologic, Inc.

Management

Yeah, I think there's couple of things we're excited about for international. First is the leadership team there Eric Compton has really put in place. As we exit this year, we basically got a completely new leadership team internationally from how we entered the year, other than our leader of the Diagnostics business in Europe, who is already showing and really been leading the way with great growth. But I think as we look to international, the molecular diagnostics business ought to be a real standout for us. I think Surgical continuing off of a smaller base, but continuing to show good growth, and Breast Health will return to some growth, as we're working a lot tighter with our dealers and getting things in place there. So I think we feel incrementally significantly better entering this year than we did at this time last year about international.

Operator

Operator

Our next question is from Tycho Peterson with JPMorgan.

Tycho W. Peterson - JPMorgan Securities LLC

Analyst

Hey, thanks. Steve, want to actually focus on margins. Guidance assumes some nice operating margin expansion. Can you talk a little bit about the drivers? I know you've over-invested during the growth boom, so can you maybe talk about some of the levers you can pull for margin expansion in 2017?

Stephen P. MacMillan - Hologic, Inc.

Management

Sure, we've clearly invested heavily, Tycho, especially on the marketing and the R&D fronts as this year was coming in well and obviously way hot on the EPS line. We've really – I would say those, we had expanded and invested more than our rate of sales, we'll probably come back into those being slightly leveragable relative to the rate of sales as we go into the current year.

Tycho W. Peterson - JPMorgan Securities LLC

Analyst

And then, as we think about Breast Health, Cigna was obviously the first to move forward with reimbursing Tomo for routine screening. Can you talk a little bit about how that's progressed and where you see other payors along that path?

Stephen P. MacMillan - Hologic, Inc.

Management

Sure, we really applaud Cigna. They obviously got on board. I would tell you it's a struggle with both Aetna and United at this point. We're working through it. We would love them to take the same approach towards their patients that Cigna did, but we're working through with them. And we basically have not assumed that they come and that could be an additional source of upside if or when they fall during the year.

Operator

Operator

Our next question comes from Bill Quirk with Piper Jaffray. William R. Quirk - Piper Jaffray & Co.: Great, thanks and good afternoon everybody.

Stephen P. MacMillan - Hologic, Inc.

Management

Hey, Bill. William R. Quirk - Piper Jaffray & Co.: Couple of questions on virals, guys. Obviously, glad to hear that everything is on track for the U.S. launches. And if we're doing the math right, I think you should be accretive to the overall Diagnostic gross margins. But, that said, we've also heard about some pricing pressure over in Europe. And so can you help just kind of set the stage for us about what you expect in U.S.? And then maybe just a couple words on what you're seeing in Europe thus far. Thanks.

Stephen P. MacMillan - Hologic, Inc.

Management

Sure. To be clear, the virals will be a very small contributor in 2017 in the United States. And that's where they're going to be coming at a much better margin. So right now they are contributing to the top line growth, and certainly top- and bottom-line in Europe, but the big pickup for us will really be more in 2018 on the margin side, as it relates to the virals.

Robert W. McMahon - Hologic, Inc.

Management

Yeah, and I think in Europe we're seeing good traction there, Bill. We talked about the Panther placements. 2016 was a very good year in Panther placements, specifically in Europe, but also internationally, in general. I think that's largely on the back of our viral system, our viral load assays. And we'll get the full benefit of that in 2017 as those instruments that were placed get a full year. The other thing is in that we noted that the revenue pull-through per Panther has increased. That's both in the U.S. as well as internationally. So I think that that's a harbinger for good growth going forward. William R. Quirk - Piper Jaffray & Co.: And just the overall pricing dynamic in Europe?

Robert W. McMahon - Hologic, Inc.

Management

Yeah, pricing is lower in Europe, but it's pretty much as expected based on our models. It's a little lower outside the U.S. than in the U.S., but not anything different than what we had anticipated. William R. Quirk - Piper Jaffray & Co.: Okay. Got it, very good. Thanks, guys.

Stephen P. MacMillan - Hologic, Inc.

Management

Great. Thanks, Bill.

Operator

Operator

Next we have Vijay Kumar with Evercore ISI.

Stephen P. MacMillan - Hologic, Inc.

Management

Hey, Vijay.

Vijay Kumar - Evercore ISI

Analyst

Hey, guys. Congratulations on a nice quarter.

Stephen P. MacMillan - Hologic, Inc.

Management

Thank you.

Vijay Kumar - Evercore ISI

Analyst

I feel like we were all waiting with bated breath and just given what's happened MedTech, we're glad to see this come through. Just maybe one on the guidance on the revenue, what does the guidance assume for OUS growth, international growth for next year? Because I would have thought, just given what happened sequentially 3Q versus 4Q international trends, any color on international would be helpful.

Stephen P. MacMillan - Hologic, Inc.

Management

Sure, it basically is in line with the total company growth rate next year. So I'd say we're picturing actually balanced growth for the first time. The last couple of years, it's been way skewed to the U.S., has been generating most of the growth. But I think we see this year really being a rebalancing (37:13). Recall the fourth – the current quarter is not indicative of a trend, given that last year's fourth quarter turns out – there was a lot more put into that last year's fourth quarter than we fully understood, just as dealers bought in to maintain their contracts against minimums and things like that. So, I think, again, we feel far better coming into this year and seeing expected growth.

Vijay Kumar - Evercore ISI

Analyst

Great. And then maybe one for – go ahead, Bob.

Robert W. McMahon - Hologic, Inc.

Management

Yeah, I was just was going to say the other thing to bear in mind there is, we had mentioned that the blood screening business will be roughly flat to slightly up year-on-year. That was a big headwind internationally through all of 2016 as the inventories and ordering patterns of our partner were adjusting. So we expect to kind of lap that. So that gives us help for turning that trajectory around as well.

Vijay Kumar - Evercore ISI

Analyst

And then maybe one for you, Bob. You did mention that the guidance doesn't assume anything on the capital deployment front. I mean just I think in your prepared remarks, you also highlighted free cash generation, right? I guess my question is what's the focus for cap deployment over the next 12 months?

Robert W. McMahon - Hologic, Inc.

Management

Yeah, we continued to focus on – we mentioned that in December we plan to call the first tranche of the remaining amount of that first tranche of convertible notes. I think outside of that, we continue to be focused on debt paydown as well as growth in M&A activities, and then finally share repurchase. The latter of those two is hard to predict, and certainly the convertible notes, we've don't those ability to actually call those formally until 2018. And so that's why we've done it. But we will be opportunistic as appropriate within the market.

Stephen P. MacMillan - Hologic, Inc.

Management

Again, just to clarify, that would be fiscal 2018.

Robert W. McMahon - Hologic, Inc.

Management

That's correct.

Stephen P. MacMillan - Hologic, Inc.

Management

December of 2017.

Robert W. McMahon - Hologic, Inc.

Management

That's correct. Thank you.

Operator

Operator

Thank you and our next question comes from Doug Schenkel with Cowen and Company. Doug Schenkel - Cowen & Co. LLC: Good afternoon, guys and thank you for taking my question. I guess, I have one question on just assumptions you're baking into guidance. It has a few parts to it. So I'll rattle through these and then I'll get back in the queue. The first part is, for new products, it seems like you might be assuming that new products contribute about 100 basis points to fiscal 2017 growth at the midpoint of guide. Is that about right? Secondly, what's your view on the sustainability of NovaSure growth, given the benefit from competitive disruptions will annualize over the course of this fiscal year? Third, are there any major blood bank tenders that come up this year that we should be contemplating in our models? And lastly, how do you expect Panther utilization to increase above the $190,000 annualized figure that you provided in fiscal 2017 based on geographic and menu expansion? Thank you.

Stephen P. MacMillan - Hologic, Inc.

Management

Hey, Doug, are you sure you don't want to throw a few more on that.

Robert W. McMahon - Hologic, Inc.

Management

Yeah, I know. One question with 74 parts. Hey, Doug, this is Bob. I'll take the first on the new products. We feel very good about that. We mentioned the $10 million in Q4. We obviously expect that to grow throughout the course of 2017. And I think you had mentioned a 100 basis point, that's probably at the low end, maybe it's a little higher than that, maybe a 105 basis point maybe at the midpoint to think about that, and that's really driven behind the Affirm and Zika. Those are probably the two largest new products. Brevera will happen, but it's in the back-half of the year, and then certainly some of the virals and so forth in the U.S. will play a role, but again, the majority of that will happen in the 2018. So that's the first question. And I think sustainability of NovaSure, we feel very good about that. But remember the formal withdrawal of the competitive product happened in our second quarter, so we expect to have larger and better growth in first and second quarters than we went out in the back-half the year. We expect growth throughout the course of the year, but the first and second quarters will be bigger than the back-half for NovaSure. In terms of the major blood banks, you need to ask Grifols, those are their customers, and so we're not going to be able to be in a position to answer to that. And then in terms of Panther utilization, we do expect, that's one of the big areas that we're focused on, that's continuing to not only place Panther systems, but increase the utilization of the installed base. So I do expect that utilization to grow in line with the forecast that we had talked about for our molecular business. Thank you, Doug. Great.

Operator

Operator

Next up, we have Isaac Ro with Goldman Sachs. Isaac Ro - Goldman Sachs & Co.: Good afternoon, guys. Thank you.

Stephen P. MacMillan - Hologic, Inc.

Management

Hey, Isaac. Isaac Ro - Goldman Sachs & Co.: Hey. So, just want to spend a minute talking about innovation. You guys have clearly done a great job restoring consistency in the core business, but maybe a little bit less appreciated has been some of the new products you put out there, both the ones you mentioned and maybe some of the ones you haven't talked about. And so, if I look at the R&D spend here, it's up a good amount year-over-year, and just thinking a little bit about how to frame the way you guys are investing your R&D dollars going forward. Maybe if you could talk a little bit about thematically where you think your best bang for your buck is invested? And as we look over a multiyear period, how should we think about investment across the various divisions?

Stephen P. MacMillan - Hologic, Inc.

Management

Sure, I think if you take a macro view at it, Isaac, we've dramatically overhauled really the R&D organizations at all three businesses and really proud – it's taken some work and it's all been happening behind the scenes, but really trying to break that grand slam or the boom bust ideas. So what we've got going on now is a lot of folks focused on both substantial innovation, but also incremental innovation. And if you take our Surgical business as an example, we had launched NovaSure and launched MyoSure and never really did any product upgrades or anything through the years, just threw them out there and then watched eventually price degrade or whatever else. So, launching MyoSure REACH is a classic example of something that we're working on. We also just mentioned, we're actually launching an upgraded NovaSure product outside the United States. You can imagine, we'll be planning on bringing that to the United States once we get that through approval. Likewise in Breast Health, instead of just focusing on the replacement for 3D Tomo, saying okay what are we going to do in the meantime and how can we leverage 3D? Well, the Affirm prone biopsy system, Brevera, there will be other things that we're looking at in that vein as well. And again, we wanted to put some points on the board before we start talking about the future, just as you know us stylistically. And then the same as it relates effectively the Diagnostics business, there were things that aren't really in play when we got here. Turbo charged the Fusion, the development of the Fusion platform, which is then opening up that ability to do the same kind of singles and doubles as it relates to future assays and be able to broaden out the menu there. And again, those will be a lot of singles and doubles that will come behind the viral load programs. And we really hunkered down early on to push the viral loads through and across the finish line. Those have kind of been up and down, on and off, and we've really put a sustained commitment and started to feel very, very good about our ability in each of the divisions to be bringing a more steady stream of innovation.

Robert W. McMahon - Hologic, Inc.

Management

Hey, Isaac, this is Bob. Just to build on what Steve's saying. Steve talks a lot about people make a difference. And so over the last several years, we've really not only focused on rebuilding the commercial teams, but also the R&D teams. And so when I think about the R&D spend, we spend roughly 8% any quarter, it can change. That's probably the right amount. But I think right now what we've done is fundamentally, as Steve mentioned, change the mindset of the organizations and how they're going about actually developing products, linking R&D with marketing, truly having insight-driven innovation and creating that competitive advantage. We spend most money as a percent of sales in our Diagnostics business, less in Breast and our Surgical businesses. I think that is probably going to stay roughly the same, but it's really the makeup of it and the leadership making a big difference in terms of how we evaluate the innovation pipeline. Isaac Ro - Goldman Sachs & Co.: That's really helpful color, thanks. And maybe just a follow-up for Bob on the financial side of the guidance. Can you talk a little bit about tax planning, maybe what's baked into your guidance this year for tax rate? And are there any opportunities that could translate to a lower tax rate that moves the needle this fiscal year or is it maybe still a longer term thing?

Robert W. McMahon - Hologic, Inc.

Management

Yeah, I think it's still a longer-term thing, Isaac. If you recall, we didn't anticipate anything actually really starting to happen until 2017 and we were actually able to pull some things forward into 2016. So you saw one of the benefits in 2016 as being having a lower tax rate relative to 2015. And so with that, we still see that kind of steady improvement, but we have actually accelerated some of those efforts, resulted in the lower tax rate in 2016. Longer term, we continue to evaluate kind of what that looks like. We're roughly on that point per year, I think that that's probably a reasonable way to model going forward, which in this 31% that we're talking about really is roughly a point better than where we were for the full-year 2016. So that's the way I would think about it. Isaac.

Operator

Operator

Thank you. And next, we have David Lewis with Morgan Stanley.

Stephen P. MacMillan - Hologic, Inc.

Management

Hey, David. David Ryan Lewis - Morgan Stanley & Co. LLC: Good afternoon. How are you doing? So couple of quick ones here. First, for Bob and then I've got – two for Bob and one for Steve. That'll be fast, I promise. So, Bob, just coming back to international for a second here, if you do the math, you go sort of from mid-single digit declines to mid-single digit growth, where you pick up 10 points of relative on 20% of your business. It's two points of growth. So it's a key driver of the improvement in 2017. Your comp adjusted growth for international though in the fourth quarter actually got worse. So just can you just help us understand why fourth quarter actually slowed comp adjusted, but you're confident you get that reacceleration in 2017?

Robert W. McMahon - Hologic, Inc.

Management

Yeah, if you look at the kind of trends of the business on a sequential basis, that's where we feel confident. We knew that we had kind of an outsized number in Q4 of last year, which resulted in your comp-adjusted numbers looking worse. But when we look at the fundamentals of the business and some of those pockets, things like molecular, Surgical, the trend in the stabilization of our Breast Health business, which is probably is the biggest – one of biggest changes and then certainly we feel pretty clear about – we have pretty decent line of sight into the inventory levels now with the blood screening business. I think those are kind of the building blocks that were headwinds last year, that certainly will be our tailwinds going into 2017. I think, Eric, as Steve mentioned, has done a tremendous job of really focusing the teams on the fundamentals. We've gone to the regional basis. We've brought in a bunch of new leaders there and I think they're just starting to get a hold on things. But I think we've seen good progress and good momentum going into 2017 on those couple of barriers. David Ryan Lewis - Morgan Stanley & Co. LLC: Okay, and then an unfun question for you and a fun question for Steve. Stock-based compensation FASB changes, any impact on your earnings for 2017? And then for Steve, fiscal 2017 guidance is in line, I think positive, but I think the enthusiasm for Hologic post our conference since September really wasn't about 2017, it was about sort of the view that this business can deliver not just one year of 5% and 10% growth, frankly, but several years of 5% and 10% growth. So I wonder if you could just sort of synthesize for shareholders what are some of those business dynamics you're seeing that give you that confidence that this isn't just one good year, but it's a few good years to come, and I'll jump back into queue. Thanks.

Stephen P. MacMillan - Hologic, Inc.

Management

Sure, the stock-based comp piece, there's no impact.

Robert W. McMahon - Hologic, Inc.

Management

No material impact.

Stephen P. MacMillan - Hologic, Inc.

Management

And I think, David, each year when on a look out, I'm always far more worried about the year further out just as I was probably more worried about 2017 earlier in 2016. And every year, what I keep seeing is our teams just keep putting more new products in place, better people in place, and I probably feel better about the sustainability of this company at any point since I've been here. Because I think by the time we go into 2018, we're going to have more products hitting. We're going to have the international business that much further along. There's so much of what Eric's focused here during this year. What we've been doing in international this year is really putting the foundation in place that I hoped and wanted to be putting in place sooner, but we really weren't doing it. So I think just fundamentally, we just keep getting stronger and stronger. The comps will be getting tougher this and that, but overall, feeling very good. We're going to have a lot of stuff hitting in late 2017 and into 2018, and that's one of the pipeline stuff will really be coming through.

Operator

Operator

Our next question is from Anthony Petrone with Jefferies.

Anthony Petrone - Jefferies LLC

Analyst

Thanks, and good afternoon. Maybe one on molecular and an update on Breast Health, OUS specifically. I'm just wondering what the capital utilization rate of Panther is at $190,000? So just kind of looking ahead, and maybe where that could actually go, longer-term not only for 2017? And then on Breast Health, I guess the question really is, Bob, going back in – I don't know, some meetings, you did speak about the 2D opportunity OUS as being pretty substantial over the next several years. So I'm just wondering if we can get an update on that opportunity specifically.

Robert W. McMahon - Hologic, Inc.

Management

Sure. So on the molecular utilization at the $190,000, I think we had talked about previously, call it roughly 30%, it's probably a little higher than that now, maybe a third of the capacity and now, which means that there's still plenty of opportunity to grow utilization on the instrumentation. It's never going to get to a 100%, but certainly, we have room to grow. And if we look at Tigris as an example, it's up in the 65% to 75% range in those utilization. So there's still plenty of opportunity there from a molecular standpoint. In regards to Breast Health, yeah, we are still enthusiastic about the opportunities both in 3D as well as 2D. I think the team has been focused and really looked at country by country, screening guidelines. How we work with not only our dealers, but also starting, more importantly, with governments and so forth and meeting some of the governments where they are. And the beauty of our 2D system is its software upgradeable to 3D. And so we have both the best 2D system as well as the best 3D system. And so that is still a strategy that we feel good about in the markets that we're focused on and an opportunity not only to place both 2D and 3D systems, but have that opportunity for upgrade over time.

Anthony Petrone - Jefferies LLC

Analyst

That's helpful. Just a follow up there would be, is 50% to 60% the goal for Panther in terms of capacity utilization and is there a round number for OUS mammography units that is the target? Thanks.

Robert W. McMahon - Hologic, Inc.

Management

I don't know if we have a specific goal. It's really on how confident and comfortable the lab is. At some stage, they're going to want a second Panther as a backup. So rather than focus on a capacity goal, what I would focus on really is we have plenty of opportunity to continue to grow utilization of our assays and our upcoming assays in the pipeline on the existing Panther.

Operator

Operator

Our next question is from Jack Meehan with Barclays.

Jack Meehan - Barclays Capital, Inc.

Analyst

Hi, thanks and congrats on the nice quarter. I wanted to follow up there on Panther. Just was wondering if you could give any updated thoughts the individual sexual health products, how they performed in the quarter. And then, as time goes on, have you seen more cross-selling of the individual products? Maybe just as you look at the labs, how many are using one test or two tests or all three with trich? Any color would be great.

Robert W. McMahon - Hologic, Inc.

Management

Yeah, maybe I'll talk to the last question first. That's one of the reasons that the utilization is growing the way it is, is the team, in particular in the U.S., has done a fantastic job of being able to sell the entire menu, and really done a customer segmentation that says, okay, if they've got chlamydia, gonorrhea, are they testing for trich? Are they testing for HPV? And that has really driven that utilization in the U.S., and it's starting to drive that utilization internationally as well, now that we have the viral loads. I will tell you in terms of growth rates for our major assays, still obviously the largest is our chlamydia, gonorrhea, CTGC assay that grew in the low-single digits. And then HPV and trich continue to grow in excess of market. So those are gaining share. We feel good about our ability to continue to drive growth in 2017 in those markets, as well or those assays.

Jack Meehan - Barclays Capital, Inc.

Analyst

Great. And one more follow-up on Panther. Just in international with the success you've had with viral load, is there a sense that you can say these customers now, a certain percentage are using viral load? And I guess what I'm trying to get to is obviously with the strength of the U.S. fleet, if there's a way that we can think about the commercial strategy here and what percentage we can think would adopt the test over time?

Robert W. McMahon - Hologic, Inc.

Management

Yeah, so we're still in the early days of the viral loads. We just now – we launched those maybe – they had the full complement six, nine months ago, obviously with the tender-based contracts in Europe. It takes some time. I think the good news is the leading indicator of that, which is the Panther placements, is happening, but it's probably a number that we expect to grow into 2017 and 2018 for sure, but it's still early days.

Operator

Operator

Our next question comes from Jon Block with Stifel. Jonathan Block - Stifel, Nicolaus & Co., Inc.: Great. Thanks, guys. And I'll try to ask two relatively quick ones. So, Bob, the first one, I think the guidance implies about 100 bps of Op margin expansion, and you mentioned somewhat shared between OpEx and gross margin expansion. So that leaves about 50 bps for gross margin, down from roughly 140 bps this year. And I certainly understand the headwinds by international growing faster in 2017 relative to 2016, but still a decent stepdown. So, can you just talk to us about that stepdown in gross margin expansion? And then are you still getting a good gross margin pull from your three major divisions?

Robert W. McMahon - Hologic, Inc.

Management

Yeah, so certainly, we've got margins that are – we finished FY 2016 at almost 66% gross margin. That's nothing to be ashamed about. We feel good about that. .

Stephen P. MacMillan - Hologic, Inc.

Management

I'd rephrase it, that we're still continuing to expand as opposed to a stepdown from (57:53).

Robert W. McMahon - Hologic, Inc.

Management

Yeah, yeah, exactly. And the international business certainly is a lower-margin business, which is going to impact some of that. And then certainly in 2016, we benefited from Surgical being outsized growth. We still expect growth in our Surgical business, but not at the level that it had in 2016. So there's some product mix in there as well. I will tell you that our operations teams are incredibly focused on continuing to improve the operational aspects of their business and we've established good pricing discipline. And I think there's still opportunities to improve margins; I think just perhaps not at the level of 2016, given some of that product mix that with had. And then in the OpEx margins, it's going to be across the product lines or product areas. As Steve mentioned, we opportunistically look to invest in places like marketing and some of the other areas. We have the ability to kind of to move some of those levers as we need to. Jonathan Block - Stifel, Nicolaus & Co., Inc.: Okay, perfect, very helpful. And then just, Steve, maybe you. Just longer term on that Surgical division, is the right way to think about NovaSure sort of flattish once you cycle through ThermaChoice? And maybe more importantly, just to take a step back, if you could opine upon MyoSure. I mean, rarely do you have 30% sustainable growth and now to the point where you've got a product annualizing at over $150 million. So just maybe talk about the sustainability of why you're seeing that sort of growth rate and just the market opportunity that you see in front of Hologic for that product. Thank you.

Stephen P. MacMillan - Hologic, Inc.

Management

Sure. I would say MyoSure has been probably our wonderful continued surprise that it's been able to generate, as you just said, two straight years of 30%-plus growth after a year in which it had looked to be slowing in the 20%-ish range, kind of really reaccelerated. We're not sure how high is up yet there. And I almost don't want to call the market, because I think we're finding more and more avenues and more and more opportunities to tap into other procedures and things. So we continue – even through the year, that growth rate has not yet slowed. We brought some news to it. And I think we see that as still being a real growth driver for us. NovaSure will clearly come back to earth in terms of growth rates. But again, we're going to be bringing news to that franchise and we've adopted a mindset that we don't accept anything but an expectation of growth, even on older businesses and it's our job to figure out how to grow them. I am confident that team will continue to find ways to keep growing what is a great, great product. But certainly at slower rates, probably, once we get through the big competitive piece.

Operator

Operator

Next we have from UBS, Jon Groberg.

Jonathan Groberg - UBS Securities LLC

Analyst

Great, thanks. I'll actually just ask one question. Steve, the capital deployment that was brought up earlier, can you maybe just talk about where you're at in terms of your team's ability to do more M&A? Whether or not you would be disappointed if you didn't do something from an M&A standpoint in 2017? I mean, it seems like where you're at as a firm, you seem to have a little bit more confidence internationally. Obviously, the core business in the U.S. is doing well, the M&A piece hasn't really kicked in yet. Thanks.

Stephen P. MacMillan - Hologic, Inc.

Management

Yeah, thanks, Jon. I would expect we'll likely do something in 2017. It might be very small. It might be more mid-size, not really sure yet. I think our still relentless focus has been always on keeping the base business growing at a healthy rate. And then I do think there may be come some opportunities. I would tell you, we'd looked at a lot of things, some of which we're patient on and we want to make sure that they make sense. So, I'm seeing a lot more. I would say, if you look at my percentage of my time spent with the divisions on business development deals today versus a year ago, it's a dramatic difference. And we're seeing a lot of good things and a lot of things that may not be making the full hurdle, because we're obviously being very disciplined as we go. But I do feel good that we're going to continue to be smart and sensible in the capabilities, have come a long way.

Robert W. McMahon - Hologic, Inc.

Management

Operator, I think we have time for one more question and then we'll wrap it up.

Operator

Operator

Our final question is from Mary Kate Gorman from Canaccord Genuity.

Mary Kate A. Gorman - Canaccord Genuity, Inc.

Analyst

Hi, Mary Kate on for Mark Massaro. Thanks for taking my question. You know, I was hoping to ask, have you begun to see more favorable reimbursement decisions in 3 Tomo as a result of the updated NCCN guidelines similar to Cigna? And along that line, do you anticipate new payors coming on next quarter as a result of payors revising coverage decisions in the new year? Thank you.

Stephen P. MacMillan - Hologic, Inc.

Management

Thanks, Mary Kate. We're certainly using the NCCN guidelines and the additional clinical data to try to drive additional private pay. I would not expect anything necessarily in the next quarter. Hopefully in the coming quarters, we would hope to continue to make progress there. But there's a lot of prickliness. Frankly, there's a lot going not private pay world right now, and this isn't necessarily getting the full attention that we think it should. But we'll continue to drive that and expect that over time we'll knock those barriers down. But I think all of that would be additional upside.

Mary Kate A. Gorman - Canaccord Genuity, Inc.

Analyst

Great, thank you.

Stephen P. MacMillan - Hologic, Inc.

Management

Okay, operator, I think that wraps us up.

Operator

Operator

Okay. Thank you. That is all the time we have for questions today. This now concludes Hologic's fourth quarter fiscal 2016 earnings call. Have a good evening.