Earnings Labs

Hologic, Inc. (HOLX)

Q3 2011 Earnings Call· Mon, Aug 1, 2011

$76.01

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Transcript

Operator

Operator

Good afternoon, and welcome to the Hologic Inc. Third Quarter Fiscal 2011 Earnings Conference Call. My name is Peter and I will be your operator for today's call. Today's conference call is being recorded. All lines are currently placed on mute. I would now like to introduce Deborah Gordon, Vice President, Investor Relations to begin the call. Please go ahead.

Deborah Gordon

President

Thank you, Peter. Good afternoon, and thank you for joining us for Hologic's Third Quarter Fiscal 2011 Earnings Conference Call. I encourage everyone to visit Hologic's Investor Relations page of our website in order to view the PowerPoint presentation related to the comments that will be made during today's opening remarks. The replay of this call will be archived on our website through Friday, August 19. Please note that a copy of the press release discussing our third quarter fiscal 2011 results, as well as our fourth quarter and fiscal 2011 guidance is available in the Investor Relations section of our website under the heading Financial Results. Before we begin, I would like to remind you of our Safe Harbor statement. Certain statements made by management of Hologic Inc. during the course of this conference call may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievement of Hologic to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, those detailed from time to time in the company's filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based. Also, during this call, we will be discussing certain financial measures not prepared in accordance with Generally Accepted Accounting Principles, or GAAP. A reconciliation of these non-GAAP financial measures to the related GAAP financial measures can be found in the Hologic's third quarter 2011 earnings release, including the financial tables in the release. Please note that today's call will consist of 30 minutes of opening remarks from management, followed by a 30-minute question-and-answer session. We therefore ask each participant to please limit his or her questions to just one, with one follow-up, if necessary. We do appreciate -- you may have additional questions, so please feel free to go back into queue, and if time permits, we'll be more than happy to take your questions at that time. I would now like to turn the call over to Rob Cascella, President and Chief Executive Officer.

Robert Cascella

Management

Thanks, Deb, and good afternoon, and thank you for dialing in to Hologic's third quarter call. Joining me on the call is Glenn Mujir, our Executive Vice President and Chief Financial Officer, who incidentally was just awarded CFO of the Year by the Boston Business Journal so congrats to Glenn. Also on the call, Steve Williamson, our General Manager of our Surgical group; Peter Soltani, our General Manager of our Breast Health group; and David Harding, who is the General Manager of our International Operations. Before I get into the quarter, I wanted to make a note on what you've most likely read in our release, that Jack Cumming has resigned from the board, and as our Chairman. We're pleased that Jack will remain with the company as a Special Advisor focused on building our international business. I also want to note that the appointment of David LeVance as our Chairman. David has been on the board since 2002 and our Lead Director since 2008. We want to thank Jack for his years of accomplishment with Hologic, and best wishes on his continued role of the company. And we also want to wish David all the best in his new capacity as Chairman. And with that, on today's call, we're going to review the highlights of our third quarter. I'd like to update you on the progress being made with our rollout of our 3D Dimensions systems and review the status of some of our key strategic initiatives, including the recent acquisitions of TCT and Healthcome. Glenn will then discuss the financial results in the quarter and also cover guidance for the fourth quarter and the year. We will then open the call up for 30 minutes of Q&A. While we're very pleased with the results for our third quarter,…

Glenn Muir

Management

Thanks, Rob. Consolidated revenues grew $30 million or 7.2% year-over-year, exceeding our expectations and driven by growth in all 4 of our operating segments. Our Breast Health segment was the largest contributor to our overall growth, increasing $15 million or 8.4%, while the 11% growth in GYN Surgical revenues, and the 4.4% growth in Diagnostic revenues, added meaningfully to revenue performance in the period. Consolidated revenue growth on a constant currency basis was 5.7% year-over-year. Revenues in the Breast Health segment grew to $205.2 million in Q3 '11 from $189.3 million in Q3 of 2010 last year. This growth was fueled by both the strength of the recurring revenue stream provided by our service offerings and the solid growth in and record sales of our breast biopsy lines. In addition, we benefited from the inclusion of revenues from the sales of MRI breast coils, having acquired Sentinelle Medical last summer. Solid growth in sales of our 2D/3D Dimensions mammography systems was a material contributor to segment's top line performance again this quarter. Our Dimensions line now represents 57% of all digital mammography system revenues versus 47% in Q2 and 37% in Q1 of this year. The vast majority of this quarter's Dimensions revenue was realized from sales of entirely new units. While only a small percentage represented revenues from 3D upgrades. 3D tomo sales are just starting in the U.S. and are still only a small portion of the overall Breast Health business. And while we expect an increased contribution from sales of these units in Q4, we still believe that meaningful 3D tomo sales won't begin to accelerate until mid-fiscal 2012. Switching to top line growth in our other segments. GYN Surgical posted double-digit revenue growth this quarter, driven by increased revenues from all of our surgical products. Revenues…

Robert Cascella

Management

Hey, thanks, Glenn. At the beginning of the year we outlined our strategy that included a strong pipeline of products for organic growth, tuck in technology acquisitions, and an international expansion initiative. We believe through the first 3 quarters of this year, we have executed in line with these expectations. Our 3D Dimensions was approved by the FDA, and we've now submitted the HTA for FDA approval. We have completed 2 tuck-in acquisitions and more recently 2 international expansion investments. We're pleased with our overall performance and solid year-over-year growth in all 4 of our business segments. In Breast Health, we're encouraged by the strong interest in 3D, GYN Surgical grew strongly on a year-over-year basis with both NovaSure and Adiana, as well as a nice contribution from MyoSure. In fact, even without MyoSure, Surgical would have posted record revenues for the quarter. We remain optimistic about Diagnostics given the improvement in ThinPrep volumes worldwide and the increasing penetration of Cervista, as well as all the new instrumentation offerings that I discussed earlier. In summary, I look forward to closing out fiscal '11 successfully and moving on to an exciting fiscal '12. Thank you all for dialing in to our third quarter call. I will now turn the call over to the operator for 30 minutes of questions. Thanks.

Operator

Operator

[Operator Instructions] Let's first go to Dave Turkaly with SIG.

David Turkaly - Susquehanna Financial Group, LLLP

Analyst

When you look at the $50 you mentioned for that miscellaneous code, can you just remind us, is that similar to what you saw for digital early on over analog?

Robert Cascella

Management

What actually happened with digital over analog was that a $50 premium was assessed over the existing analog rate. But it was presented as a combined rate for digital that averaged around $130 versus $80 from the former analog rate, and I'm approximating. What we would imagine happens with tomosynthesis is that it will be an aggregate code that will be higher than the current digital code. So the $50 is clearly in line with our expectations. You should also note that the digital mammography was about 5x as expensive as analog. We're talking roughly about $150,000 over premium, over digital for tomosynthesis.

David Turkaly - Susquehanna Financial Group, LLLP

Analyst

The follow-up would just be, given the trends in all the data you mentioned in terms of the mix and the percentage, would you say as we look at Breast Health growth going forward, this quarter you saw a nice acceleration, should we kind of assume that you can maintain something similar to that level even before we see like a specific code release for tomo?

Robert Cascella

Management

I'd like us to really hold to the initial forecast that we gave for the first couple of years, and that anticipated that there would not be a reimbursement code. And that number, just to remind everyone, again, we assumed that there would be a purchase of roughly 500 to 700 systems over that period of time. That's probably the best information that we have at this point in time.

Operator

Operator

Let's next go to Goldman Sachs, Isaac Ro.

Isaac Ro - Goldman Sachs Group Inc.

Analyst

Just want to touch briefly on the outlook for the balance of your fiscal year. I know you're not looking past the October timeframe, but your assumptions on the hospital spending environment both for capital equipment and the pricing you have in the tomo procedures. What are you assuming as you move into the rest of the coming months here, you have a little quite of delay, but given the uncertainty in the market, your assumptions behind the guidance will be very helpful.

Robert Cascella

Management

Yes. It's obviously different for each business segment. So if we look at capital equipment, we still think there's a lot of downward pressure on the capital equipment for medical technologies. The difference here is that this is a new technology. So the adoption uptick will be based on whether or not the market believes that this is better technology. It's not simply replacing the current product, just replacing it, what we would think is a more efficacious technology. So I think that the opportunities for digital mammography moving to tomosynthesis will almost be irrespective of what's happening with some of the other diagnostic imaging products because of the newness and the clinical benefits of the technology. With respect to some of our other product lines, I think the procedure-oriented businesses, women going in for exams, we see that as being more stable. I'm not certain it is planned to increase, but we are certainly seeing a recovery from the dramatic falling that occurred last year. And really in the second half of last year, it was almost like procedure volumes fell off a cliff. We think that, that's more than stabilized today. The other businesses within our Surgical business, there is some downward pressure on procedure volumes. And a lot of that has to do with increasing deductibles. Certainly the unemployment situation doesn't help that these are nonlife threatening diseases, albeit them debilitating. And as a result of that, it is our sense that we will see ongoing pressure or headwinds in those areas, probably for the next year. Now we're maintaining a level of optimism because we think TPC will promote more activity in the marketplace. We think MyoSure is a brand-new product that otherwise does not have another clinical alternative. And we are so early on with Adiana that we think that there is still growth potential there. But nonetheless, that the overall market itself, we think it's going to be under pressure.

Isaac Ro - Goldman Sachs Group Inc.

Analyst

Great. And then just one follow-up on me, on the China strategy, very interested in your initiative there. Wondering, how should we think about the impact that your EQS [ph] growth rate in Breast Health world have on your overall Breast Health division? Is that part of the strategy just to say?

David Harding

Analyst

Yes. This is David Harding. I think that it's going to take a little bit of time for that strategy to play out in a meaningful way and impact the overall Breast Health growth rates, although we are looking into certainly, the middle part of next year to launch new products into the Chinese market. Keep in mind that the Chinese mammo market is still relatively immature, although it is growing fairly rapidly. So we believe that the impact will come probably in the tail end of the coming fiscal year, as opposed to right away in the early quarters. The current product line sold by Healthcome is an analog set of units. And so those are by their definition, less high-value items and will therefore, have a smaller contributing effect in the near term.

Operator

Operator

At Piper Jaffray, let's go to Bill Quirk.

William Quirk - Piper Jaffray Companies

Analyst

Couple of quick questions. Rob, just to circle back to ThinPrep business and the comment that it was up in the quarter. Can you put color as to perhaps why? I mean Is this due to some of the early provisions of healthcare reform bill? Is this just plain old easy comps from last year? Any color would be great, and I got a follow-up.

Robert Cascella

Management

Yes. And I think you just hit it. I think it's an easier comp against last year. I mean if we think about it, all that's really happened, though, is that the domestic business has stopped bleeding. So I think we're back to a level of patient activity, and that is complemented by a stronger international growth. So we're seeing the overall business is increasing as a result of the stabilization of the U.S. market and growth on an OUS basis.

William Quirk - Piper Jaffray Companies

Analyst

Okay, great. And then recognizing that we're still early here, any color on the actual timing of the sales cycle for tomo?

Robert Cascella

Management

I think it's a 6-month process, but Peter Soltani is here. And Peter is out on the field everyday with our account managers. Peter, what do you think about that?

Peter Soltani

Analyst · tomosynthesis. And then one on HPV, you've mentioned market shares for the assays are increasing across small and mid volume labs. I'm wondering upon approval, can you remind us if those platforms will be sold into new accounts or will they be placed in an attempt to just increase assay sales

Sure. Thanks. This is Peter. Yes, I think it is strongly a typical capital cycle. People have to budget for it. They can be with other capital projects. There's an implementation phase. They have to have rooms ready. They have to have folks trained. So it isn't a decision-making process that happens overnight. So, again, I would say it's really typical capital cycle.

Operator

Operator

David Lewis of Morgan Stanley.

William Carlile

Analyst

This is Bill Carlile on the line for David Lewis. So when -- as we look at the replacement cycle for mammography here, I think you guys have been saying that it's 18 to 24 months out before we start to see replacements really start to accelerate and start to draw a larger share of placements there. I want to see if there's an update on that guidance and kind of we're you guys see the steady state of replacements in the mix going forward.

Robert Cascella

Management

Yes. If you recall when we talked about that, it really assumed that there was not a new product. There wasn't tomo. It was replacing -- it was the normalized replacement cycle that we said would average somewhere between 12% to maybe even 15% of the installed base. We think that happens with the natural maturing of the installed base, but we think the more important dynamic is the introduction of a new technology. And that new technology is tomosynthesis, which we think accelerates that replacement cycle. What will be necessary in order for that to happen in a much grander or broader way is clearly expanded clinical validation, which is happening every day, and obviously, the setting of a permanent reimbursement code. So with those 2 other pieces filled in this puzzle that we're talking about, we think that the replacement cycle accelerates due to the notion of this technological obsolescence that we keep talking about, which is quite different than the normal replacement cycle of maturing equipment. This is people dealing the compelled divide because of competitive dynamics, because of clinical efficacy, because of all the benefits of this technology, not so dissimilar to what happened in the analog to digital conversion.

William Carlile

Analyst

That's helpful. And then to follow up, you guys mentioned that Dimensions mix in the quarter was in the 57% range. Was that a worldwide mix number? Or is that strictly U.S.?

Peter Soltani

Analyst · tomosynthesis. And then one on HPV, you've mentioned market shares for the assays are increasing across small and mid volume labs. I'm wondering upon approval, can you remind us if those platforms will be sold into new accounts or will they be placed in an attempt to just increase assay sales

Yes. This is Peter. Yes, that was a worldwide number.

William Carlile

Analyst

Okay. Can you give us any clarity on how that breaks out between U.S. and OUS?

Peter Soltani

Analyst · tomosynthesis. And then one on HPV, you've mentioned market shares for the assays are increasing across small and mid volume labs. I'm wondering upon approval, can you remind us if those platforms will be sold into new accounts or will they be placed in an attempt to just increase assay sales

I don't think we have -- we have broken out anything on domestic versus international for that one?

Glenn Muir

Management

No, we haven't. It's Glenn. But the bulk of the growth is on the U.S. side. The international side on Dimensions had been fairly stable in the last few quarters. So where you're seeing the growth coming from is on the U.S. side. And what's important there is really the mix shift because Dimensions is the new product with the much higher selling price that we're able to achieve, and this are the 2D or the 3D mode. So that will help to continue to drive revenues as we go forward as that shift continues.

Operator

Operator

Thomas Kouchoukos at Stifel, Nicolaus. Thomas Kouchoukos - Stifel, Nicolaus & Co., Inc.: Just wanted to start with the kind of the formal release that came out this morning from [indiscernible] that they're requiring payers to cover birth control and other preventative care for women. I wanted just to be clear whether or not this included permanent birth control in your Adiana system. And then also if you could comment on kind of what your perspective is in terms of what this means for your Adiana, ThinPrep and HPV test going forward.

Robert Cascella

Management

The quick answer is yes, it does. And I'll have Steve Williamson to comment on what we believe some of the longer-term benefits will be from this.

Steven Williamson

Analyst

We believe that beginning in our August of 2012, there will be no co-pay or deductible associated with permanent contraception, and obviously Adiana's covered in that. That's for private payers. So as people renegotiate their contracts, these private-payer contracts will take out the deductibles and take out the co-pay. So we think this is a big plus for us moving forward. Thomas Kouchoukos - Stifel, Nicolaus & Co., Inc.: Okay, great. And then just to follow on, I think you guys mentioned that the seminars you're holding for 3D have been quite successful. One of things we've seen as we've press releases coming out from different centers across the country saying they have adopted 3D technology is that it hasn't been necessarily academic centers. And I think we had had expected that early on, it would just be the academic centers. I'm curious are you seeing more kind of mainstream centers come on than maybe you would have expected to begin with?

Robert Cascella

Management

The quick answer would be, yes. And I think that the centers that are buying these are not the academic research centers. They're buying it because obviously, they believe in technology and also they believe that there's a strong marketing benefit to having such a powerful technology available for the patients.

Operator

Operator

At RBC Capital Markets, let's go to Bill Bonello.

Bill Bonello - RBC Capital Markets, LLC

Analyst

I have a question and a follow up. The first one is just a point of clarification, the 500 to 700 system placement -- Dimensions system placements that you've talked about, is that both 2D and 3D? Or is that just 3D?

Robert Cascella

Management

So when we were talking about that, that was actually 3D. We were saying over the first 2 years that we thought that the market would -- could absorb 500 to 700 3D systems.

Bill Bonello - RBC Capital Markets, LLC

Analyst

But that's what I had thought, but then I got a little confused with today's discussion. Okay. And so then the more important question, the mix that you've seen so far between 2D and 3D, is that kind of consistent with what you had expected? And when you think of the customers that are buying these systems, are they maybe customers that had already budgeted to buy a 2D even before tomo was approved?

Robert Cascella

Management

I'll ask Peter to respond to that.

Peter Soltani

Analyst · tomosynthesis. And then one on HPV, you've mentioned market shares for the assays are increasing across small and mid volume labs. I'm wondering upon approval, can you remind us if those platforms will be sold into new accounts or will they be placed in an attempt to just increase assay sales

Sure. This is Peter. Again, I would say that it's still fairly early in the process. So it's really hard to split out the mix. And certainly, folks that did budget for 2D would have the money for 2D. The advantage certainly for them would be that the 2D would give them the opportunity to upgrade 3D at a point in time where they can basically get the funds budgeted.

Operator

Operator

And let's move on to Rich Newitter with Leerink Swann.

Richard Newitter - Leerink Swann LLC

Analyst

I just want to maybe start off with the reimbursement on tomo. I think you had said that in the beginning of fiscal 2012, you guys were going to figure out a way to more formalize the approached reimbursement. Could you just expand on that? What does that mean? And are there any further timelines that you're willing to put out there with that?

Robert Cascella

Management

Yes. The timeline is -- probably would be more challenging that I think I can explain with a fair amount of color what we mean by the process. So one of the areas that we're really focused on is we certainly want CMS to support this, but we want the ACR to support it as well. And we also are looking for some advocacy groups and the like. Well that is taking some time relative to the clinical work that's been done, clinical papers that are being written. We think some of the first of these will surface at RSNA this year. And then later, also with some of our European studies at the ECR in March. And so as a result of that, we have delayed a more aggressive stand with the paying organizations until we get really our doc in order with respect to clinical validation in a much broader way.

Richard Newitter - Leerink Swann LLC

Analyst

And does that -- maybe that you're delaying the aggressive stance, do you maybe have more comfort today versus a few months ago delaying that, given some of the initial success that you described with the committee and the initial submissions on the miscellaneous code?

Robert Cascella

Management

Well, I think it's a little bit of that. We're not kidding ourselves at all. If we don't think that's a permanent strategy -- but we are also encouraged that customers are interested in buying tomosynthesis or 3D Dimensions almost irrespective of reimbursement right now. And I think it's because the technology benefits are so compelling. So that part of it is probably very, very encouraging. But don't misunderstand at all. We think there's a true sense of urgency of getting a permanent reimbursement code and our path to doing so may have been delayed, but only delayed because of things like clinical papers and results from clinical trials being published, not because we're at all comfortable with the miscellaneous code that's being used on a very limited basis.

Richard Newitter - Leerink Swann LLC

Analyst

Okay, that's good color. And then just one last one. During the quarter, would you mind just characterizing the mix between 2D and 3D? Would you say it was more that you saw an increased willingness to make a purchase or interest in your platform on the 2D side, where the pathway to getting to a 3D is being established? Or was it fairly evenly split, increasing interest in 3D and 2D?

Robert Cascella

Management

It's a great question. So if you think about the market, what we're finding is that a lot of the folks that have not bought mammography products yet are buying Dimensions products and they're buying it because of competitive reasons and they're buying it for the upgrade path that it represents. We don't view those as being the early adopters of tomo. The folks that are buying the 3D configured product are buying that because they believe in tomo, and they already do digital mammography and are using their Selenia as a either a way to fund the partial purchase of a new system or they're adding tomosynthesis to their practice. But they really are 2 different camps. If you look at international right now, it's almost a 50-50 split in terms of the customer profile and what their buying pattern is.

Operator

Operator

And now on to Jayson Bedford, Raymond James. Jayson Bedford - Raymond James & Associates, Inc.: First, in terms of the tomo centers, how are you seeing the use of the device meaning, screening or diagnostic? And I guess are you seeing a center by one and seeing how it goes? Or do most of your tomo centers have more than one device?

Robert Cascella

Management

I'll have Peter comment on that. Peter?

Peter Soltani

Analyst · tomosynthesis. And then one on HPV, you've mentioned market shares for the assays are increasing across small and mid volume labs. I'm wondering upon approval, can you remind us if those platforms will be sold into new accounts or will they be placed in an attempt to just increase assay sales

Sure. This is Peter. I think it's a bit of a mix. I mean it just depends on the potentially previous exposure the physician might have had to somewhat through a reader study or training. So they will, based on their preferences, will either start in the diagnostic mode, we certainly have centers that start out in a screening mode. There are centers that will start with one to gain experience. Again, as I mentioned, there is a tremendous amount of training, a lot of training that needs to go along with these units. So they will take the more cautious approach to, again, at least some sites that have had the physicians within their facilities well trained and are capable of implementing it for screening the process of board. So there isn't really any one particular approach at this point. Jayson Bedford - Raymond James & Associates, Inc.: Okay. And just as a follow up, and this may be a confusing question, but trying to get a little clarity here. It seems like you got a few 2D Dimensions units in the field, let's call it at least a few hundred. Are those folks separate from the 500 to 700 devices that you've talked about that could be purchased within the first 2 years? Or is there a lot of overlap between those 2 buckets?

Robert Cascella

Management

When you say are they separate, the folks that bought 2D may in fact upgrade to 3D mammography and they are included in the 700, but it is unlikely that those that recently bought a 2D Dimensions are going to be the early adopters of tomo. That was my point earlier. I think they are -- we are locking in that pocket for future upgrades, but my sense would be that they are not the initial buyers of tomo. The people that will be the initial buyers of tomo they will be limited upgrades, which as Glenn indicated in his portion of the script, there has been very few upgrades and the bulk of the tomo units that are being sold are being sold as new systems. And that's what we anticipate being the vast majority of these initial systems that are sold over the first 2 years. Is that helpful?

Peter Soltani

Analyst · tomosynthesis. And then one on HPV, you've mentioned market shares for the assays are increasing across small and mid volume labs. I'm wondering upon approval, can you remind us if those platforms will be sold into new accounts or will they be placed in an attempt to just increase assay sales

That's helpful.

Operator

Operator

At JPMorgan, let's go to Tycho Peterson. Tycho Peterson - JP Morgan Chase & Co: Are you able to give us an organic growth rate? I mean I understand the currency contribution, but can you back out what Interlace and TCT and Sentinelle did? Do you guys have true kind of organic number?

Glenn Muir

Management

Tycho, it's Glenn. The overall growth rate, are you talking by segment? Or are we talking about overall? The overall... Tycho Peterson - JP Morgan Chase & Co: I was asking overall but if you want to give it to us by segment.

Glenn Muir

Management

I can help you with that a little bit, thinking it through, though. Let me -- if we go to, and after the call maybe just pull up the presentation on the PowerPoint because it does give the segments and what the growth per segment was. And it gives it on a constant currency. So the first thing, let me just point out that the overall growth was 7.4%, the constant currency was 5.9%. And you're asking for the organic without TCT and without MyoSure. That was just a small number though, Tycho. So you almost can look at the segment. And we don't give out the exact millions for each of those groups within their product categories. But we're just starting off with those products. So they did not have any kind of meaningful impact on that organic growth rate. In this quarter, I think going forward, we're excited that they will. But you can kind of eyeball it by looking at this segment PowerPoint. Tycho Peterson - JP Morgan Chase & Co: Okay. But Sentinelle didn't either? Because you did that in August, right?

Glenn Muir

Management

Yes. Well Sentinelle is part of the Breast Health, and Breast Health had $205 million in revenue. So Sentinelle was just a tiny, tiny piece of that overall segment. And that's really what I meant. When you look at the products, a lot of them all hit different areas, but Sentinelle is in Breast Health, and TCT is in Diagnostics and MyoSure is in GYN Surgical. So when you kind of just doing some rough math, I mean it becomes obvious that most of the growth was organic from current products. Tycho Peterson - JP Morgan Chase & Co: So maybe on Breast Health, you've had a lot of growth from kind of a service component. Two questions there, how much of that is driven by tomo versus just kind of the aging installed base? And then can you also comment on the underlying dynamics in the 2D market? I mean you've got Siemens coming in as prices kind of dropped off there and pulling down the 2D market.

Robert Cascella

Management

Yes. I think we're certainly seeing -- I'll go to the second part of that question. I think we're certainly seeing in some of the international markets, where Siemens is presenting certainly a competitive challenge because of lower pricing. I don't think the dynamics have changed dramatically in the U.S. market right now, and we're certainly not saying -- there's aggressive competition, there's always, but certainly not being above the norm. We would anticipate that 2D pricing over time will come down as capital equipment matures, but we think we're very early on with both Dimensions and obviously tomo at this point in time. So I don't think ASPs have been challenging for us yet. And that's not to say that they won't be. With respect to -- and the first part of your question, Tycho, maybe if you can just... Tycho Peterson - JP Morgan Chase & Co: Well just on the service business. I mean service has been driving a lot of the growth in Breast Health, how much of that is a function of the aging installed base versus more service around tomo?

Robert Cascella

Management

Well no, there's really not of a lot of service on tomo because first off it's a new product, so it's going to be under warranty. Secondly, it's a software product. So in fact, over time, if tomo were to experience explosive growth, there will almost be a decline in service because you're replacing a lot of new units -- or older units under service contract with new units that will be under warranty. We're not seeing that effect yet, but we would anticipate it. As the tomo curb accelerates, you're going to have a very high ASP at a very high gross margin, but you're probably also going to lose the service revenue on the existing Selenia that we would anticipate being traded in to buy that tomo unit. Does that make sense? Tycho Peterson - JP Morgan Chase & Co: Yes.

Operator

Operator

Let's move on to Citi, Amit Bhalla.

Amit Bhalla - Citigroup Inc

Analyst

Rob, I wanted to clarify one of your comments, you said on reimbursement. You said that the $50 premium that you initially were seeing was in line with what you were thinking. But I remember in previous conversations and even on the last conference call you said that was more like $25 to $30 premium that you're looking for. Could you clarify what you're expecting?

Robert Cascella

Management

I think the $50 clearly is at the high end. I think we have been saying a range of $25 to even $50. And in fact some of our customers are even looking for a higher rate. But I don't -- I have no crystal ball as to acknowledging where it's going to end up. I think we have said that a reimbursement as low as $25 may be livable. But we certainly would think that something on the higher end of that would make this much more attractive from a cost perspective because it is the added cost of not just the equipment, but it's also the added leading time. So between a combination of technical and professional, I think everybody would feel better with the higher end of that range being the reality.

Amit Bhalla - Citigroup Inc

Analyst

Okay, and then secondly, on Cervista HTA. I think I remember last conference call you said you were expecting 180 days approval, which would put it in the fourth quarter, and now you're saying first half of 2012. Could you just clarify what's going on there? What's...

Robert Cascella

Management

Well, remember, we did have a delay in submission. So we took a step back, so we were about a month to 60 days delayed. We think that the normal 6-month period would have taken us into the first quarter, and we are still thinking along that line, but we're kind of hedging our bet because it's always difficult to put a stake in the ground relative to FDA timing. We have to respond to a variety questions and so on and so forth. So we tried to put a little bit of a cushion on when we think the product will be available, given that we are now just in the process of responding to FDA questions. And that was really the rationale.

Operator

Operator

We have time for one more telephone question at this time. Let's go to Jefferies, Anthony Petrone. Anthony Petrone - Jefferies & Company, Inc.: One on tomo, I just wondering if the price discussions on tomo have changed much, if at all, from market assessment runs pre the approval of tomosynthesis. And then one on HPV, you've mentioned market shares for the assays are increasing across small and mid volume labs. I'm wondering upon approval, can you remind us if those platforms will be sold into new accounts or will they be placed in an attempt to just increase assay sales?

Robert Cascella

Management

Sure. I think with respect to the notion of tomosynthesis -- I mean, Peter, I don't know, you may want to comment on that.

Peter Soltani

Analyst · tomosynthesis. And then one on HPV, you've mentioned market shares for the assays are increasing across small and mid volume labs. I'm wondering upon approval, can you remind us if those platforms will be sold into new accounts or will they be placed in an attempt to just increase assay sales

This is, again, Peter. I think that certainly the pricing has been -- domestically has been relatively stable, and it's pretty much in line with where we thought things would end up. I think certainly as just pointed out earlier on the international side, you will see more pricing competition in many areas. But then again I do think we have a product that from a tomosynthesis standpoint is highly refined and it becomes a huge competitive advantage that helps us to drive sales.

Robert Cascella

Management

That's great. And as far as the -- you're referring to the automation and instrumentation products on our HPV assay? Anthony Petrone - Jefferies & Company, Inc.: That's correct.

Robert Cascella

Management

Yes. There's going to be just like there is today with imager and some of our other instruments, processes and the like, they are a bunch of different market models. The one that will probably most frequently be used is really a per use model, but it will be built into the use of the product versus reselling capital equipment. But it's not to say that, that's 100% exclusive approach. I mean we do sell capital equipment as well. But the goal here is really not to rush out and try to have some quick wins with capital equipment. It is really to secure higher volume labs, where we have an opportunity to really reap the benefits of the assay versus a one-time sale of instrumentation.

Operator

Operator

Ladies and gentlemen, thank you. That is all the time we have for questions today. This now concludes Hologic Third Quarter Fiscal 2011 Earnings Conference Call. Have a good evening.