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Edited Transcript of HOLX earnings conference call or presentation 31-Jul-19 8:30pm GMT

Q3 2019 Hologic Inc Earnings Call

BEDFORD Sep 13, 2019 (Thomson StreetEvents) -- Edited Transcript of Hologic Inc earnings conference call or presentation Wednesday, July 31, 2019 at 8:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Karleen M. Oberton

Hologic, Inc. - CFO

* Michael J. Watts

Hologic, Inc. - VP of IR & Corporate Communications

* Stephen P. MacMillan

Hologic, Inc. - Chairman, CEO & President

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Conference Call Participants

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* Anthony Charles Petrone

Jefferies LLC, Research Division - Equity Analyst

* Chris Lin

Cowen and Company, LLC, Research Division - Research Associate

* Daniel Gregory Brennan

UBS Investment Bank, Research Division - Senior Equity Research Analyst of Healthcare Life Sciences

* Daniel Henry Macek-Alwell

Piper Jaffray Companies, Research Division - Research Analyst

* Daniel Louis Leonard

Deutsche Bank AG, Research Division - Research Analyst

* Jack Meehan

Barclays Bank PLC, Research Division - VP & Senior Research Analyst

* Jaime Lynn Morgan

SVB Leerink LLC, Research Division - Associate

* Mason E. Austen

Morgan Stanley, Research Division - Research Associate

* Tycho W. Peterson

JP Morgan Chase & Co, Research Division - Senior Analyst

* Vijay Muniyappa Kumar

Evercore ISI Institutional Equities, Research Division - MD

* Xiaoxiao Ma

BofA Merrill Lynch, Research Division - Associate

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Presentation

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Operator [1]

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Good afternoon, and welcome to the Hologic, Inc. Third Quarter Fiscal 2019 Earnings Conference Call. My name is Eduardo, and I am your operator for today's call. Today's conference call is being recorded. (Operator Instructions)

I would like now to introduce Mr. Mike Watts, Vice President, Investor Relations and Corporate Communications, to begin the call. Thank you.

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Michael J. Watts, Hologic, Inc. - VP of IR & Corporate Communications [2]

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Thank you, Eduardo. Good afternoon, and thanks for joining us for Hologic's Third Quarter Fiscal 2019 earnings call. With me today are Steve MacMillan, the company's President, Chairman and CEO; and Karleen Oberton, our Chief Financial Officer. Steve and Karleen both have some prepared remarks, then we'll have a question-and-answer session.

Our third quarter press release is available now on the Investors 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 through October -- through August, excuse me, 23.

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 can be found in our earnings release.

Finally, any percentage changes we discuss will be on a year-over-year basis, and revenue growth rates will be expressed in constant currency, unless otherwise noted.

Now I'd like to turn the call over to Steve MacMillan, Hologic's CEO.

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Stephen P. MacMillan, Hologic, Inc. - Chairman, CEO & President [3]

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Thank you, Mike, and good afternoon, everyone. We're pleased to discuss Hologic's financial results for the third quarter of fiscal 2019, our fifth consecutive quarter of strong, consistent overall results.

Total revenue of $852.4 million and non-GAAP earnings per share of $0.63 were both above our guidance. Similar to recent periods, revenue growth was driven by our largest businesses, Molecular Diagnostics and Breast Health, and we're also happy that the performance of our Surgical division continues to strengthen. These strong results continue the positive momentum that started to build in our core businesses throughout 2018. During this time, each of our divisions has made progress, to varying degrees, on the 4 strategic levers we can pull to drive growth. Let me touch on each of these to illustrate both the progress we have made and the opportunities ahead.

First, commercial execution in the United States has been our strong suit, enabled by our excellent sales teams and best-in-class products such as our Genius 3D Mammography systems, our Panther molecular diagnostics instrument, our ThinPrep liquid pap test and our MyoSure and NovaSure surgical devices. Across these core brands, we are executing effectively as we build on our #1 market shares, maintain premium pricing and partner with our customers to drive demand. These products are the foundation for our strategy and overall financial success. But since we already have high domestic market shares in some lower-growth end markets, we need to do more to drive attractive growth. That's where the other 3 strategic levers come in.

To start, we have worked hard over the last several years to expand into international markets, where we have much more headroom to grow shares than we do domestically. Not long ago, some of you may recall that I described our business outside the United States as a startup, or said another way, it was basically treated as an export business. Today, thanks to strong leadership and very deliberate efforts to build our channel strength, international has emerged as a solid and consistent grower.

Third, we have doubled down on innovation and revitalized our R&D pipelines to build around our core product assets. Today, after several years of significant changes in our R&D capabilities, all of our divisions have established a healthy cadence of innovation for the first time, and the results are beginning to benefit our financials. For example, sales of recently launched products totaled more than $180 million in the third quarter. This represented about 21% of our total revenue and grew more than 40% compared to a year ago.

And fourth, to supplement our organic growth, we have announced 3 tuck-in acquisitions over the last year, all built around our Breast Health core to further diversify our revenue and enable us to operate across the continuum of patient care. Given the strength of our cash flows and balance sheet, we believe these smaller deals will be an important part of our future growth and hopefully not just in Breast Health.

With that introduction, let's discuss our third quarter results in more detail. Revenue of $852.4 million grew 4.7% in constant currency, ahead of our expectations. Within this, the acquired Faxitron and Focal businesses contributed $12.8 million to revenue, and we are off to a good start with these deals. Excluding sales from our divested Blood Screening business, which declined in the third quarter, revenue of $838.2 million grew 5.3% in constant currency. This was an acceleration of 30 basis points sequentially compared to our second quarter growth rate.

In terms of geography, domestic sales of $642.5 million increased a healthy 4.2% in the third quarter. Excluding our divested Blood Screening business again, U.S. growth would have been 5.0%, accelerating for the fourth consecutive quarter. Our largest franchises, Molecular Diagnostics and Breast Health, once again led the charge as we continue to build around our Panther and Genius installed bases. Additionally, we are also pleased to see our U.S. Surgical business improve again, continuing the steady progress that began early last year.

Outside the United States, sales of $209.9 million increased 6.2% in constant currency. This was a solid performance, but growth was a little slower than the recent quarters mainly due to macroeconomic and political challenges in our small Latin American business, which is mostly Breast Health. Excluding Latin America, OUS growth would have been about 200 basis points higher. More broadly, total Diagnostics and Surgical both grew low double digits outside the United States, and Medical Aesthetics returned to growth as well.

Now let me provide some more detail on our divisional revenue results. Let's start with our biggest business, Breast Health, where underlying trends remain strong. Global Breast Health sales finished in line with our expectations in the third quarter and totaled $325.4 million, a solid increase of 6.7% against a tough prior year comparable. As we have said many times before, our Breast Health division today is much steadier and more diversified than it ever has been with innovative, market-leading products across the continuum of patient care and around the globe.

In terms of geography, domestic sales drove Breast Health growth in the quarter with revenue increasing a very strong 8.9%. OUS Breast Health sales declined by 1.5%. This was driven mainly by the challenges in Latin America that I mentioned earlier as well as the annualization of some prior year tender wins and order timing.

In terms of subsegments, imaging sales grew 6.1%, while interventional sales increased 9.5% as we focus on selling our growing portfolio. In imaging, sales of our Genius 3D systems increased strongly driven by our new 3Dimensions and 3D Performance gantries. These innovative, new products have now clearly established themselves at the heart of our capital portfolio. Other new products, including Intelligent 2D, Clarity HD and SmartCurve, also contributed nicely to imaging growth as did revenue from our acquired Faxitron business.

In interventional, our third quarter results benefited from our focus on portfolio selling as well as revenue from our acquired Focal business. These positives more than offset a headwind from lower Brevera sales due to the supply constraints we have previously discussed.

Before I turn to Diagnostics, I want to spend a minute on our pending acquisition of SuperSonic Imagine, or SSI, a French innovator in cart-based ultrasound technology. This tuck-in deal is very consistent with our capital deployment goals. It's fairly small at an enterprise value of roughly $85 million and leverages our existing call points. It's also expected to be accretive to our revenue growth rate, albeit with some slight dilution to EPS in the near term.

We have wanted to expand in ultrasound for a while as the technology is used across the full continuum of Breast Health patient care. We had previously done a small distribution deal to sell the Viera portable ultrasound scanner, and acquiring SuperSonic Imagine will enable us to further enter the larger cart-based market, which has been growing at a high single-digit rate. Having evaluated several targets in this space over the past few years, we believe that SSI's newest product, the Aixplorer MACH 30, represents best-in-class technology, highlighted by excellent image quality. So SSI will support our reputation for providing clinically differentiated products. The MACH 30 is used as a supplement to mammography for screening women with dense breasts and also to help guide biopsies and surgeries. Importantly, less than 15% of SSI's revenue is generated in the United States, which provides an excellent opportunity to leverage our strong domestic sales channel. Over time, we are hopeful that the MACH 30 can develop into a platform a bit like Genius, one that enjoys significant clinical differentiation and onto which we can layer software and hardware upgrades.

From a process perspective, we expect to purchase about 46% of SSI's shares in the next few days. This will enable us to obtain Board seats and give us a controlling interest in the company. Then we will file a cash tender offer to acquire the remaining shares and hopefully close the deal in the first quarter of our fiscal 2020.

Now let's turn to Diagnostics, where revenues of $305.4 million increased a strong 5.1% in the quarter. Excluding sales from our divested Blood Screening business, which declined in the quarter, Diagnostics revenue increased an even better 7.1%. Molecular remains the growth driver here based on the productivity of our R&D team, which has now earned U.S. clearances in 11 consecutive quarters, and the sophistication of our lab- and physician-based sales teams.

In the quarter, worldwide molecular sales of $170.9 million grew 11.7%, our third consecutive quarter of double-digit constant currency growth despite a challenging prior year comp. Internationally, molecular grew 22.1%, well into the double digits for the 12th time in 13 quarters. Although international is a small piece of our total molecular franchise, we are seeing very strong performance there. And in the U.S., although we already enjoy high market shares in key assay categories, molecular sales still grew 9.4%. This reflects how we work collaboratively with our customers, especially our largest ones, to drive volumes and better patient care in established testing categories.

In terms of product, molecular growth was broad-based in the quarter as customers consolidated testing on our large installed base of fully automated Panther instruments. Sales of our largest Aptima women's health assays for chlamydia, gonorrhea, HPV and trichomonas all increased solidly. In addition, although sales of new Diagnostics products are still relatively small, they more than doubled in the quarter, led by our quantitative viral load tests and by Panther Fusion.

Moving on. Cytology and perinatal sales were $120.3 million in the third quarter, a small increase of 1.3%. Cytology sales increased slightly all outside the United States, while perinatal sales were flat. In the United States, growth in the cytology market remains challenged due to our high market shares and longer cervical cancer testing intervals.

Elsewhere in Diagnostics, revenue related to our divested Blood Screening business was higher than expected at $14.2 million, although this decreased by 23.7% compared to last year. As a reminder, this revenue mainly reflects low-margin products and services under transition agreements we have with Grifols. We expect Blood Screening revenue will total about $10 million in the fourth quarter and decline further to about $30 million for our 2020 fiscal year.

Before we discuss GYN Surgical, let me mention our leadership transition in Diagnostics. As you probably know, Tom West accepted a CEO position at another company in June. We are happy for Tom and even more excited that Kevin Thornal has succeeded him as President of our Diagnostics division. As many of you know, Kevin led our European Breast Health turnaround a few years ago and guided Cynosure through a difficult stabilization process. He has a great track record of strengthening businesses, so he will fit well with our already strong Diagnostics leadership team. The division is performing well today, and we believe Kevin's fresh leadership will accelerate the progress we have already made, especially in business development.

Now let's shift gears and cover GYN Surgical, where sales of $112.2 million increased 5.2%, our fastest growth in 8 quarters. This continues a steady cadence of improvement under new leadership since the business bottomed in the first quarter of 2018. Thanks to a strengthening sales force, MyoSure continues to be a healthy grower, and we have built on this foundation by introducing new related products such as our Fluent Fluid Management System and our Omni Hysteroscope. And we are excited that more new products are on the way based on increased efforts in both internal development and licensing.

Now let's turn to Medical Aesthetics, where sales of $85 million represented about 10% of consolidated revenue and declined 5.5%. Despite this decline, we saw additional signs of improvement for the second consecutive quarter. Our U.S. sales force stabilized and posted its third consecutive quarter of sequential growth under the leadership of Eric Anderson, who has now replaced Kevin as President of the division. And OUS sales grew at a low single-digit rate after 4 consecutive quarters of declines. So while we still have a long way to go at Cynosure, we believe we are beginning to find our footing.

To round out the revenue discussion briefly, skeletal sales of $24.4 million grew 9.8% based on solid growth of our DXA systems for bone density and body composition testing.

So to wrap up, our third quarter results represent our fifth consecutive quarter of good performance. Building on our market-leading brands in the United States, especially in Breast Health and Diagnostics, we are expanding internationally, churning out new products from our revitalized R&D pipelines and effectively integrating tuck-in acquisitions while looking for more. Overall, we are executing well, but know that we have many more opportunities still ahead of us, which gives us confidence in our future.

Now let me turn the call over to Karleen.

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Karleen M. Oberton, Hologic, Inc. - CFO [4]

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Thank you, Steve, and good afternoon, everyone. In my remarks today, I'm going to walk through the rest of our third quarter income statement, touch on a few other key financial metrics then finish with our updated financial guidance for 2019 as well as the fourth quarter.

Unless otherwise noted, my remarks will focus on non-GAAP results, and percentage changes will be on a year-over-year basis in constant currency.

As Steve described, we are pleased with our third quarter results as revenue of $852.4 million and EPS of $0.63 exceeded our guidance. We benefited from strong performance by our largest businesses, Breast Health and Molecular Diagnostics as well as improved results in our Surgical division. Both operating and net margins improved, reversing recent trends. We also deployed capital in accordance with our strategic priorities by agreeing to acquire SuperSonic and by repurchasing $50 million of stock. Our overall performance has been very solid through 3 quarters of the fiscal year, and as a result, we are tweaking our financial guidance upward despite an incremental foreign exchange headwind.

With that introduction, let me start by reviewing our P&L for the third quarter. Gross margins of 61.6% decreased 100 basis points compared to the prior year period. This was primarily due to the strong U.S. dollar, trade tariffs in China, product sales mix especially related to Cynosure's performance and increased service costs. Compared to the second quarter of 2019, however, gross margins did improve sequentially by about 60 basis points as some of the onetime headwinds we mentioned last quarter dissipated, but the FX headwind got worse. Looking ahead, we expect better margins in the fourth quarter due to improved product mix, absorption benefits, the ramp of new product sales and our ongoing cost-reduction efforts.

Moving on. Total operating expenses of $276.4 million decreased 0.9% in the third quarter. However, excluding Faxitron and Focal, operating expenses declined 3.9%, reflecting strong discipline -- expense discipline, especially in G&A. But as Steve said, we remain fully committed to funding internal innovation, and our R&D pipeline has never been more productive than it is today. Based on improvements in the top line and strong operating discipline, operating margin of 29.2% increased by 40 basis points in the third quarter. Operating margin also improved sequentially to our best level since the first quarter of 2018.

Other expenses net totaled $28.8 million in the third quarter, 11.4% less than a year ago as benefits from our currency hedges outweighed higher interest expense. Given the strengthening U.S. dollar, we expect similar hedge gains in the fourth quarter. Our currency hedges will reset as we move into 2020, theoretically eliminating any gains as currencies stay constant.

Finally, net margin of 20.1% increased 80 basis points compared to the prior year period, our best result since the first quarter of 2017. In addition to better operating margins and lower other expenses, we also had a slightly lower effective tax rate. Overall, our net profitability remains very healthy.

All this led to non-GAAP net income of $171.6 million in the third quarter and non-GAAP earnings per share of $0.63, which exceeded our guidance.

Now I'll quickly touch on a few other financial metrics. In the third quarter, we repurchased 1.1 million shares of our stock for $50 million, helping reduce our shares outstanding and boosting EPS. As of quarter end, we had a little more than $210 million remaining on our buyback authorization. Since 2016, we have put our strong cash flows to work, buying back more than 24.6 million shares of stock for $926 million, which has been a great investment and use of our capital. This doesn't even include the cash we used to retire convertible debt that was in the money.

As we cleaned up our balance sheet, we also lowered our overall leverage ratio, which stood at 2.5x at the end of the third quarter. We remain comfortable around this level, recognizing that the ratio could fluctuate based on the timing of acquisitions and buyback activity.

Finally, we generated $138 million of free cash flow in the third quarter. Our strongest cash flow enables us to simultaneously pursue tuck-in acquisitions while also acting on our share repurchase authorization.

Now I'd like to shift gears and discuss our non-GAAP financial guidance for the full year and fourth quarter. As a reminder, our updated guidance does not include the impact of our pending acquisition of SuperSonic Imagine. Based on our good third quarter results, we are increasing our constant currency revenue guidance slightly and raising the low end of our EPS forecast.

Let's start with revenue. As a reminder, we previously guided to sales of $3.325 billion to $3.345 billion, which represented constant currency growth of between 4.3% and 4.9%. Based on our third quarter results, we are increasing our revenue guidance to $3.335 billion to $3.350 billion, which includes approximately $50 million of revenue from our divested Blood Screening business. Based on recent exchange rates, our new revenue guidance translates into constant currency growth of 4.7% to 5.2%. This is better than our last forecast and much better than our initial 2019 guidance, which called for growth of 2.8% to 4.2%. For modeling purposes, let me remind you that U.S. dollar has strengthened materially compared to our prior fiscal year. In fact, based on recent exchange rates, we estimate that currency fluctuations will reduce reported revenue by roughly $36 million in fiscal 2019. This is an incremental headwind of more than $5 million relative to our previous guidance.

Despite this, we feel confident about growth in our core businesses and our ability to control expenses. As a result, we are raising the low end of our EPS guidance slightly. We now expect EPS of $2.42 to $2.44 for the year, which represents reported growth of between 8.5% and 9.4%. This is better than our initial 2019 EPS guidance, which was $2.38 to $2.42, even as we have absorbed the net effect of a worsening currency headwind and made reinvestments for future growth. This updated full year guidance is based on diluted shares outstanding of about 272 million shares and an effective tax rate of approximately 22%.

With only one quarter remaining in our fiscal year, this annual guidance implies revenue of $834 million to $849 million in the fourth quarter. Compared to the prior year period, this reflects growth of 3.5% to 5.3% on a constant currency basis. On a reported basis, our guidance reflects revenue growth of 2.5% to 4.4%. On the bottom line, we expect EPS of $0.64 to $0.66 in the fourth quarter, which implies very strong growth of between 10.3% and 13.8%. Obviously, this is higher quarterly EPS growth than earlier in the year just based on the timing of revenue and expenses.

As a reminder, our fourth quarter of 2019 has 1 fewer selling day than the prior year period, although this occurred over the Independence Day holiday, so we don't expect a significant impact. Also recall that Medical Aesthetics revenue is always seasonally weaker in the summer months. And finally, as Steve mentioned, we expect Blood Screening revenue to decline from the third quarter level.

As you update your forecasts, we encourage you to model at the middle of our guidance ranges as we have tried to set realistic ranges that incorporate recent foreign exchange rates as well as potential upsides and downsides.

Before we open the call for questions, let me conclude by saying that we are pleased with our performance in the third quarter of 2019 with Molecular Diagnostics and the Breast Health driving solid growth and Surgical strengthening. These businesses, along with our international franchises, are well positioned to drive future growth, given the strategies we have in place. Both operating and net margin improved in the quarter, and we continue to put our strong cash flows to work through tuck-in acquisitions and share repurchases. Based on all this, we are raising our annual revenue and EPS guidance slightly.

With that, I will ask the operator to open the call for questions. (Operator Instructions)

Operator, we are ready for the first question.

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Questions and Answers

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Operator [1]

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All right. We'll take our first question from Vijay Kumar from Evercore ISI.

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Vijay Muniyappa Kumar, Evercore ISI Institutional Equities, Research Division - MD [2]

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Congratulations on a nice quarter here. Congratulations, Steve. And just 2 quick ones, Steve. Maybe one on -- maybe I'll start with the Breast Health, right? This really was strong. I'm just curious on what drove this. CapEx environment seems to be really strong. So was this more of the strong CapEx environment that you're seeing? Or you had some FDA regulation on dense breasts. Are you seeing some uplift from there? And maybe could you also comment on how the order book is shaping up on the Breast Health side?

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Stephen P. MacMillan, Hologic, Inc. - Chairman, CEO & President [3]

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Sure, Vijay. I think the capital -- certainly, capital spending looks pretty good in hospitals right now. We continue to feel good about that. I do think that 3D, it's hard to put an exact number on what the breast density legislation is, but we are certainly able to have conversations that nobody else can with the customers as they're gearing up to make purchases.

And just as a reminder, for people, we are the only 3D that has an FDA indication approved for dense breasts. And as there's more and more legislation driving towards disclosing dense breasts -- breast density, it clearly plays to our advantage. So I think we feel like we've been certainly winning, and we're on the leading edge of the technology there. So it's just a good place to be, and our team is continuing to get better and better at really selling the overall value proposition that comes with the best product in the market.

To your second piece on the order trends, we don't get too far ahead, but I would say orders continue to look good for us.

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Karleen M. Oberton, Hologic, Inc. - CFO [4]

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Yes, and I would just add, kind of beyond the gantry activity in the capital environment, I think our teams are continuing to come up building that capability and selling the portfolio of products as well as continuing growth in our service revenue.

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Vijay Muniyappa Kumar, Evercore ISI Institutional Equities, Research Division - MD [5]

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Just to add onto that, Steve. If you piece in all the different elements, execution has gotten better. It was good to see some of the laggards, Aesthetics and GYN, turn the corner. And you're layering on this tuck-in deals that you've done, which will annualize next year. Are we now at a place where Hologic can lay claim to being a mid-single growth asset?

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Stephen P. MacMillan, Hologic, Inc. - Chairman, CEO & President [6]

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Sure, Vijay. I think we feel really good. When you consider -- Pete Valenti, we are with him. Obviously, he's been running our Breast Health business for 5 years right now. He's reminding us that the first strategic plan inherited, it showed the traditional old days of growth curve, and it would have been a decelerating or really a declining business in 2018, 2019.

I want to get -- we want to be careful not to get too far ahead of ourselves on exactly where we are. We want to just keep putting numbers on the board. I think, candidly, we were trying to chase some numbers a few years ago, and I think we got a little ahead of ourselves trying to proclaim where we are. I think at the end of the day, let the numbers keep speaking for themselves and getting back to strong execution in our markets, and I think we'll show where we fit there. So thank you.

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Operator [7]

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(Operator Instructions) We'll now take our next question from Doug Schenkel from Cowen.

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Chris Lin, Cowen and Company, LLC, Research Division - Research Associate [8]

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This is Chris on for Doug today. Steve, in your prepared remarks, you mentioned that customers are consolidating molecular diagnostics assays onto Panther, and that it has been a driver of growth. Can you just elaborate a bit more on that comment? Specifically, are customers consolidating women's health and virology assays onto Panther?

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Stephen P. MacMillan, Hologic, Inc. - Chairman, CEO & President [9]

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Sure. It's bits of both. What -- primarily, it's just continuing to expand our growing women's health assays. As we mentioned, we got 11 straight quarters of FDA clearances in the United States. And I'd say, truthfully, it's probably a little bit more of still getting more women's health stuff as the women's health line is expanded and, to some degree, certainly, the virology kicking in.

But yes, I think the way to think about our Panthers and the assays, it's sort of this wonderful gift that keeps giving every quarter. We keep placing more Panthers in the labs. And every quarter, each Panther that we have is generally doing more revenue. So we have sort of a force multiplier here of more of an installed base and then more menu coming through. And it's a combination of more of the women's health plus some virals and just really continuing to build. And that's what's driving -- you got 9 -- almost 9.5% growth in the United States, where it's strong market shares already.

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Karleen M. Oberton, Hologic, Inc. - CFO [10]

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Yes. And I would just add to what Steve said the elements that he talked about, the ability to add menu on the Panther, it's also the value proposition for our customers that as we expand our menu, they get more leverage out of the Panther. And I think that's -- a lot of what we're seeing is the value that customers see in the Panther.

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Chris Lin, Cowen and Company, LLC, Research Division - Research Associate [11]

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Okay. And can I just go back to revenue guidance? You beat fiscal Q3 revenue guidance by about $20 million, but you only increased full year guidance by about $7 million to $8 million. Looks like FX is an incremental $5 million headwind. So this would imply that you reduced underlying full year guidance by about $5 million to $10 million. So can you just help us bridge the revenue guidance a bit more?

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Karleen M. Oberton, Hologic, Inc. - CFO [12]

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Yes. And so I might just look at it a little different way. If you looked at our second half of the year guidance from our last guide, we're at the midpoint to where we are now. It has increased overall for the second half of the year while absorbing the incremental FX. So again, I think the original guidance at Q3 that we gave in prior quarter would have indicated extremely high fourth quarter. We're pleased with how Q3 went and pleased that, overall, we've raised the second half of the year revenue guide.

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Operator [13]

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We'll now take our next question from Raj Denhoy from Jefferies.

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Anthony Charles Petrone, Jefferies LLC, Research Division - Equity Analyst [14]

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It's Anthony in for Raj. So maybe just a couple on the SuperS deal and maybe just a little bit more detail on expected revenue contribution next year and maybe a little bit on the growth profile of that asset and just the underlying margin profile of that business as we move into fiscal 2020. And then I'll have a quick follow-up on Diagnostics.

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Stephen P. MacMillan, Hologic, Inc. - Chairman, CEO & President [15]

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Sure, Anthony. Until we close that deal, we're going to avoid getting too far into the details. But we think, generally, they did about in the high $20-ish million in revenue in 2018, and it's growing at what looks to be a low double-digit rate. So as we consolidate that and ultimately once we close on the deal, we'll give a little more information. But I think as we're thinking about at the lowest level, it'll drop in $30-ish plus million of revenue at some point. We don't have it -- we won't have it probably fully closed until our first quarter, as we talked about, but feel really good about its underlying growth rate and, frankly, the technology itself. And as a big reminder, most of their revenue right now is outside the United States. So it brings us nice revenue there, and our U.S. sales force is chomping a bit to get their hands on it. So we think it'll be a clear double-digit grower of an exciting new product for us.

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Anthony Charles Petrone, Jefferies LLC, Research Division - Equity Analyst [16]

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That's very helpful. And just on Diagnostics. Maybe just a little bit on the share front. So certainly, sounds that volumes are doing well on the Molecular side. But anything on share just when you consider a number of recent launches around competitors out there, whether it be in Europe, in the U.S.?

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Stephen P. MacMillan, Hologic, Inc. - Chairman, CEO & President [17]

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Yes. I think the way we think about share is our international molecular business grew 22%. Our U.S. business grew over 9%. I think we'll stack that up with pretty much anybody. And ergo, I think we're probably growing faster than the market without knowing specific shares.

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Michael J. Watts, Hologic, Inc. - VP of IR & Corporate Communications [18]

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Yes. It's Mike, Anthony. I think despite those very high shares in most of the key categories, I think what the team has done a really good job of doing is working with our customers to drive underlying demand and drive testing to guidelines and those kind of things. So that's helped us grow the business even though the shares are already pretty high.

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Operator [19]

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We'll now take the next question from Tycho Peterson from JPMorgan.

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Tycho W. Peterson, JP Morgan Chase & Co, Research Division - Senior Analyst [20]

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Steve, GYN Surg, you commented steady progress in U.S. Can you just touch on NovaSure and MyoSure? I didn't hear you break those out.

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Stephen P. MacMillan, Hologic, Inc. - Chairman, CEO & President [21]

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Sure, Tycho. I think MyoSure continued to be really strong, and I think we stopped giving the Invader piece. I think the way I think about it is MyoSure was still a clearly double-digit grower. Feeling great about it. NovaSure is still declining in that probably high singles level. We'd like to be a little bit better. But overall, love the trajectory of the business.

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Michael J. Watts, Hologic, Inc. - VP of IR & Corporate Communications [22]

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And as a reminder, we've introduced some new products there as well between our new fluid management system, which is called Fluent, and the new Omni Hysteroscope. And those are clearly -- those are related to MyoSure and are clearly helping drive growth as well.

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Tycho W. Peterson, JP Morgan Chase & Co, Research Division - Senior Analyst [23]

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And then on SSI, a couple of things. You got the Clarius deal that you had before for distribution. Curious how those fit together. And then obviously, their cart-based system gets used in a lot of markets, vascular, gastroenterology, other areas. So I'm curious about how you're thinking about some of those kind of nonmammography-based areas.

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Stephen P. MacMillan, Hologic, Inc. - Chairman, CEO & President [24]

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Sure. Our focus is clearly going to be just in the mammography space. So if there's opportunities beyond that, we could always partner that or whatever with the technology. But our clear focus will be in the breast area. And I think it's compatible with Viera. So we'll now have both a portable as well as a cart-based option. And frankly, I think to a large degree, the cart-based options is going to be the bigger drivers of revenue here. So I think we've been learning more and more about the space and excited to have the chance to really get a cart-based offering that we haven't had. Thanks, Tycho.

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Operator [25]

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We'll now take your next question from Jack Meehan from Barclays.

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Jack Meehan, Barclays Bank PLC, Research Division - VP & Senior Research Analyst [26]

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Want to go back to the Breast Health segment. Just one modeling. How much was the contribution from Focal and Faxitron in the quarter? Do you break that out? And was also curious, the international commentary around Latin America. Just a little bit more color on that and whether -- do you think that's resolved going in the fourth quarter? Does the fourth quarter guidance assume that stays pressured?

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Karleen M. Oberton, Hologic, Inc. - CFO [27]

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Jack, it's Karleen. So I think from Focal and Faxitron, I think we indicated they contributed just over $13 million of revenue in the quarter. When you think about international, Lat Am is clearly the smallest piece of the Breast Health business, but it was down almost 50%. And while we've guided -- well, our guidance assumes a little bit of improvement in Q4 for that business. That will be down as well year-over-year. And I think just in general, international Breast Health, we did see some movement of orders from Q3 to Q4 as well as, again, in the prior year period, we'd had some large tenders that obviously didn't repeat this year.

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Jack Meehan, Barclays Bank PLC, Research Division - VP & Senior Research Analyst [28]

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Great. And then one more follow-up on Breast Health. If I look at the service revenue in the quarter just from the Q, the $117 million, it looks like that was up about 1% year-over-year. So that slowed down. Just curious if there was anything to call out related to that. And maybe just give us an update in terms of some of the software upgrades and service and just where you think you are in the cycle.

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Karleen M. Oberton, Hologic, Inc. - CFO [29]

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Yes. So I think we -- I think the expectations on service growth is in line with what we see. I think one of the nuances here is as we place new gantries, we have the cycle with customers will go under warranties for a year period and we have a lapse in the service contract revenue until they re-up. So that low single-digit growth is kind of what we expect.

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Operator [30]

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We will now take our next question from Dan Leonard from Deutsche Bank.

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Daniel Louis Leonard, Deutsche Bank AG, Research Division - Research Analyst [31]

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A couple of -- for Karleen. Karleen, on gross margin, was there any downside variance in the quarter besides foreign currency? And if so, what was the driver?

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Karleen M. Oberton, Hologic, Inc. - CFO [32]

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Yes. I would say beyond the foreign currency and the tariffs, the other was mix and specifically in Cynosure. So if you think about Q3 last year was, what I'd call, the height of the women's health product from a comp perspective, which those products had a higher gross margin portfolio profile than the rest of the Cynosure business. So I would say that was the second biggest driver, and then obviously, we mentioned some higher service costs.

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Daniel Louis Leonard, Deutsche Bank AG, Research Division - Research Analyst [33]

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Okay. And I was specifically trying to focus on downside versus plan as opposed to year-over-year. Is it still the objective? I mean you've previously thought gross margins would have been only slightly down year-on-year in 2019, and that looks like they'll be down well more than that. Could you address that variance and also talk about being able to defend the gross margin line going forward?

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Karleen M. Oberton, Hologic, Inc. - CFO [34]

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Yes. So I think from our original guide and what we had talked about for margins, I think that one of the biggest drivers is the increasing strengthening U.S. dollar, which has impacted the gross margin line, I think coupled with what I've mentioned last quarter. So last quarter, we had talked about a number of onetime items, but what is continuing here as well is some higher service costs that we do have teams focused on to improve. But I think what's also equally important is that when you look at our operating income margin and net margin have both improved despite the headwinds we're facing with gross margin, which leads to our ability to have strong discipline in our operating expense to still drive results.

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Operator [35]

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We'll now take our next question from Bill Quirk from Piper Jaffray.

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Daniel Henry Macek-Alwell, Piper Jaffray Companies, Research Division - Research Analyst [36]

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Great. This is Dan on for Bill. I appreciate your comments on utilization within Panther instruments. It sounds like you're working well with customers to drive that figure. How are you thinking about that going forward in terms of utilization? It sounds like it's a growing figure.

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Michael J. Watts, Hologic, Inc. - VP of IR & Corporate Communications [37]

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Dan, it's Mike. Yes, we try to update that number formerly at the end of our fiscal year. So probably, we won't give you a specific number. But I mean your intuition is right. I mean that's generally been growing kind of in the high single-digit range year-over-year, that being Panther utilization per box. So there's some good progress there.

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Daniel Henry Macek-Alwell, Piper Jaffray Companies, Research Division - Research Analyst [38]

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Okay. Great. And then just another one on Molecular to follow up. That's another double-digit quarter. And then how are you guys thinking about that growth rate heading into the fourth quarter and then maybe over the longer term? I know you've said high single digits, but it's been pretty consistently outperforming. So if you could just touch on that.

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Stephen P. MacMillan, Hologic, Inc. - Chairman, CEO & President [39]

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Yes. I think we continue to think about it as a high singles, probably lower end of high singles, and plan for that and try to deliver a little bit better certainly helps. But we wouldn't be ready to call it a long-term double-digit growth, especially with the competitive environment and everything else. But we feel like we're doing very well there.

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Operator [40]

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We'll now take our next question from Derik De Bruin from Bank of America Merrill Lynch.

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Xiaoxiao Ma, BofA Merrill Lynch, Research Division - Associate [41]

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This is Ivy Ma on for Derik today. So I have one on SSI and have a follow-up on Cynosure. So I know SSI is targeting EBITDA breakeven for the year. Understand that you wanted to be more conservative and guided to slight dilutive for next year. So just wanted to see if there's any additional color or consideration there.

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Stephen P. MacMillan, Hologic, Inc. - Chairman, CEO & President [42]

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When we bring it into us, we reported net income, not EBITDA. So on a -- while they may be breakeven on the EBITDA basis, they're losing money on an operating basis. So that's the difference there. And obviously, in our hands...

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Karleen M. Oberton, Hologic, Inc. - CFO [43]

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Yes. I don't think we've changed strategically kind of investments or kind of spend habits that they had. It's just, as Steve pointed out, a different profitability metric.

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Michael J. Watts, Hologic, Inc. - VP of IR & Corporate Communications [44]

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I think, Ivy, just to remind you, I think what we said in our original press release there that -- was the expectation would be I think less than 1% dilutive for next year or so. We think that's very manageable in the context of the overall P&L.

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Stephen P. MacMillan, Hologic, Inc. - Chairman, CEO & President [45]

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Yes. And we'll probably in a position when we give guidance for next year to be able to incorporate that in on the next call.

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Xiaoxiao Ma, BofA Merrill Lynch, Research Division - Associate [46]

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Sounds great. And for Cynosure, congrats on the launch for the new contouring product recently. Any updated thoughts on outlook for the segment for the rest of the year and next year?

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Stephen P. MacMillan, Hologic, Inc. - Chairman, CEO & President [47]

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Go ahead, Karleen.

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Karleen M. Oberton, Hologic, Inc. - CFO [48]

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I was just going to say that I think as we look -- we're happy with the stabilization. Really pleased that we're able to launch the new products, although I don't think they're going to be big, meaningful drivers of growth that currently create some excitement with the sales force. I think as we exit the year, we expect the division to return to growth but albeit on a much weaker comp. So feel good about where we're at right now.

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Operator [49]

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And I'll take your next question from David Lewis from Morgan Stanley.

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Mason E. Austen, Morgan Stanley, Research Division - Research Associate [50]

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This is Mason on for David today. I just want to touch on Surgical. You have a new competitor coming to the market with Cerene. Just wondering if you could talk about how you think about the competitive dynamics with the segment moving forward with NovaSure and in the next fiscal year.

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Stephen P. MacMillan, Hologic, Inc. - Chairman, CEO & President [51]

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Sure, Mason. I think we continue to feel good about the direction and the results that we're generating. We've looked at the clinical package for Cerene. As you may know, there's a lot of questions around that company and business and a lot of stuff going on over there. So we just keep focusing on our customers on our innovation and feel good about where we're going.

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Mason E. Austen, Morgan Stanley, Research Division - Research Associate [52]

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And on the Brevera supply constraints, you referenced this as a weighing on interventional results into the quarter. I was just wondering if you could potentially break that out and potentially provide an update as to when you expect to be back to full supply.

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Stephen P. MacMillan, Hologic, Inc. - Chairman, CEO & President [53]

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Yes. We're not going to get into -- the level of impact is fairly small in the grand scheme. But I think, as we've said, we probably really won't be back in the full supply until later on into 2021 -- or fiscal '20 rather, end of our next fiscal year.

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Operator [54]

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I'll take your next question from Richard Newitter from SVB Leerink.

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Jaime Lynn Morgan, SVB Leerink LLC, Research Division - Associate [55]

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This is Jaime on for Rich. A quick question. So I didn't think I heard you break out any of the subsegment directional commentary on growth within Medical Aesthetics. So I was wondering if you could provide any sort of commentary on the different trends between skin, body and women's health.

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Stephen P. MacMillan, Hologic, Inc. - Chairman, CEO & President [56]

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At the end of the day, we're not providing the breakouts per se given the size of the business. But overall, I'll tell you, skin was up nicely. Women's health was down significantly over last year because that was little like 12 months ago almost to the day when the FDA letter came out. So we were doing very well with the women's health line last year at this time, and the body segment is down a bit.

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Jaime Lynn Morgan, SVB Leerink LLC, Research Division - Associate [57]

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Okay. Great. And then just within the U.S., you're saying that you saw some sequential improvement there. So just curious. You guys had mentioned some marketing initiatives that were launched at the beginning of last quarter. Just wondering if some of that is coming from the strength of those marketing initiatives.

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Stephen P. MacMillan, Hologic, Inc. - Chairman, CEO & President [58]

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Yes. I think it's coming from 2 things. We feel really good particularly about the Brooke Shields campaign that we have on SculpSure. There's been a lot of positives on that. And the sales force has really hit a good spot now, where we've got a combination of some great seasoned veterans, and frankly, most of the leadership of the sales organization are the long-term veterans of the company, the Cynosure pre, before we acquired it, supplemented out with a lot of great teams on the ground. So it's a combination really of the marketing and the teams in place and then really focused on bringing a pipeline of new products that'll start to kick in over next year.

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Operator [59]

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We will now take our last question from Dan Brennan from UBS.

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Daniel Gregory Brennan, UBS Investment Bank, Research Division - Senior Equity Research Analyst of Healthcare Life Sciences [60]

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Steve, Karleen and Mike, I guess I wanted to ask first question on breast. If you will, Mike, can you just walk us through a little bit about the strength that you're seeing there and kind of segment out kind of the contribution or how we should think about Genius versus the newer gantries' dimensions and profile? Just wondering what the runway is on each of those to sustain this type of growth rate.

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Stephen P. MacMillan, Hologic, Inc. - Chairman, CEO & President [61]

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Sure. I think overall, really, the 3Dimensions and 3D performance have, by far, become the bulk of the sale now. So the old days of dimensions, 3,000, 6,000, 9,000 largely given way to the 3D Performance and the 3Dimensions still under the Genius banner. But I think the new products, both high end and a slightly more performance is slightly defeatured on the 3DPerformance, both providing us really good opportunities to both go high end and also the lower end with our customers.

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Karleen M. Oberton, Hologic, Inc. - CFO [62]

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And I would just add, from a runaway perspective, I think we've talked about the overall market penetration from 2D to 3D as well as our own installed base would give us roughly 3,000 to 6,000 more gantries to convert to 3D and I'd say steady cadence of gantry placements since 2015, about 1,000 per year that gives us nice runway.

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Daniel Gregory Brennan, UBS Investment Bank, Research Division - Senior Equity Research Analyst of Healthcare Life Sciences [63]

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And then just one final one. Just on the M&A front. Sounds like tuck-ins are the kind of focus going forward. But just wondering, Steve, just remind us to the extent like you were to see something bigger, like what's your appetite in terms of size? And maybe any color on the pipeline as it stands today.

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Stephen P. MacMillan, Hologic, Inc. - Chairman, CEO & President [64]

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Sure, Dan. I think we're -- while not a stated policy, we're generally thinking, okay, we're generating $600 million to $700 million of free cash a year. Probably not thinking about spending more than that in any given year on acquisition. I think it's kind of a good disciplinary. So that's not a formal policy never to be deviated from, but I think it should frame in kind of the thinking. And I think we're certainly hunting much more in a 100 -- a couple of hundred million kind of range versus anything that starts with a B. So thank you.

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Operator [65]

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Thank you. That is all the time we have for questions today. This is now -- this now concludes the Hologic's Third Quarter Fiscal 2019 Earnings Call. Have a good evening.