Earnings Labs

Hologic, Inc. (HOLX)

Q4 2011 Earnings Call· Tue, Nov 8, 2011

$76.01

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Transcript

Executives

Management

David P. Harding - Senior Vice President and General Manager of International Robert A. Cascella - Chief Executive Officer, President and Director Deborah R. Gordon - Vice President of Investor Relations Peter Soltani - Senior Vice President and General Manager of Breast Health Glenn P. Muir - Chief Financial Officer, Executive Vice President of Finance & Administration, Treasurer and Director

Analysts

Management

Bill Bonello - RBC Capital Markets, LLC, Research Division Jonathan P. Groberg - Macquarie Research Isaac Ro - Goldman Sachs Group Inc., Research Division Jonathan Block - SunTrust Robinson Humphrey, Inc., Research Division Nandita Koshal - Barclays Capital, Research Division Thomas Kouchoukos - Stifel, Nicolaus & Co., Inc., Research Division Sara Michelmore - Brean Murray, Carret & Co., LLC, Research Division Richard Newitter - Leerink Swann LLC, Research Division David R. Lewis - Morgan Stanley, Research Division William R. Quirk - Piper Jaffray Companies, Research Division

Operator

Operator

The Hologic Inc. Fourth Quarter and Fiscal 2011 Earnings Conference Call. My name is Jessica, and I'm your operator for today's call. Today's conference is being recorded. [Operator Instructions] I would now like to introduce Deborah Gordon, Vice President, Investor Relations to begin the call.

Deborah R. Gordon

Analyst

Thank you, Jessica. Good afternoon and thank you for joining us for Hologic's Fourth Quarter and 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, November 25. Please also note that a copy of the press release discussing our fourth quarter and fiscal 2011 results, as well as our first quarter and fiscal 2012 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 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 achievements 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, circumstances or conditions 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 Hologic's fourth 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 A. Cascella

Analyst · Goldman Sachs

Thank you, Deb. Good afternoon and thank you for dialing in to Hologic's Fourth Quarter Conference Call. Joining me on the call today is Glenn Muir, our Executive Vice President and Chief Financial Officer; Steve Williamson, who is dialing in. He's on the road today. He's our General Manager of our GYN Surgical group; Peter Soltani, our General Manager of Breast Health; and David Harding, the General Manager of International Operations. Today, I'm going to cover several points. We'll summarize the fourth quarter performance, discuss recent macroeconomic trends and how they impact our business, give you an update on the growth of our digital mammography business, including key elements of the very promising launch of our dimension 3D, or tomosynthesis. I'll provide you with a brief review of other key businesses and reconfirm our strategic vision for fiscal '12 and beyond. Glenn will then talk about financial results in greater detail and provide our fiscal guidance for 2012. We'll then open the call up for 30 minutes of Q&A. We are once again pleased with our results for this past quarter. For the eighth quarter in a row, we've achieved record revenues. In Q4, revenues of $467 million increased 9% over last year's fourth quarter. We also reported year-over-year growth in all 4 of our operating segments. Non-GAAP earnings per share of $0.34 was above our guidance and 12% above last year. Overall, I think we were very, very pleased with the financial results. Operationally, we had several positive events occur in the quarter, such as our acquisition of Healthcome, FDA clearance of 2 products and a CE marking for a third. While it's difficult to have a discussion about financial performance without some reference to the global economy, the capital equipment market appears to be stable, but customers are…

Glenn P. Muir

Analyst · Goldman Sachs

Thanks, Rob. Consolidated revenues of $467 million this quarter versus $428 million last year grew $38.7 million or 9% 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 $21.5 million or 10.9% year-over-year. Our Diagnostic segment posted strong performance this quarter, increasing $15.7 million or 11.7% year-over-year. And our GYN Surgical and skeletal health segments, each contributed modestly higher revenues, with increases of 1.4% and 2.1%, respectively. Consolidated revenue on a constant currency basis increased 7.8% year-over-year. The positive foreign currency impact provided a $5.4 million benefit to the top line and approximately $800,000 to income before taxes. Revenues in our Breast Health segment grew to $219 million in Q4 from $198 million in Q4 of last year. This year-over-year growth of 10% came from a $12.4 million or 9.2% increase in product revenues and a $9.1 million or 14.4% increase in service revenues. Foreign currency added approximately 0.9% or $1.8 million to the year-over-year growth this quarter. Breast Health product revenues primarily benefited from strong sales of our 2-D/3-D Dimensions mammography systems, as well as from the 20% year-over-year growth in breast biopsy sales. Our digital mammography product sales increased to $83.3 million in the quarter, representing 38% of total Breast Health revenue. Service at $71.9 million, was 33% of total Breast Health revenue. Looking closer at the digital mammography product sales, revenue of $83.3 million was 18% higher than Q3 of last year and 7.8% higher than -- I'm sorry, 18% higher than Q3 of this year and 8% higher than Q4 of last year. This growth is being driven by a significant increase in both units and revenues of our new Dimensions line, which is accounted for almost…

Robert A. Cascella

Analyst · Goldman Sachs

Thanks, Glenn. I just want to remind everyone that we're holding our Analyst Day at the RSNA in Chicago this year. Once again, that event will take place on Tuesday, November 29 and will begin at 8:00 in the morning. The agenda will really be a much deeper dive into Dimensions and a look at some of the influential data that will be coming out of the Oslo study, as well as Mass General. Thank you very much, and we really appreciate you participating on this call. And I'd like to now turn the call over to the operator so that we can open it up for Q&A.

Operator

Operator

[Operator Instructions] We'll first go to Jon Groberg from Macquarie.

Jonathan P. Groberg - Macquarie Research

Analyst

Obviously a lot of questions, and we can obviously just ask one, and one that most people are kind of focused on is guidance. I guess there is one thing to kind of nit-pick at here, would be that still your earnings growth is kind of tied to your revenue growth. Maybe you can just talk about as you think about '12, what the puts and takes are in terms of getting a little bit more earnings leverage from the top line that you're talking about?

Glenn P. Muir

Analyst · Goldman Sachs

Yes. I think it's a combination of a couple of things. I mean obviously we think we do get better leverage as our revenues materialize and as our revenues grow more quickly. We also think that product mix is a big contributor. So in providing guidance, we took a maybe perhaps a conservative view on product mix, but they affect material changes in gross margin as we shift to higher margin tomosynthesis products, higher margin Diagnostic products and/or surgical. So there's really a blend in terms of the assumptions that were used in that gross margin. We believe that depending on that, combined with an uptake in revenue, could materially change the margins within that range.

Operator

Operator

We'll now go to Thomas Kouchoukos from Stifel, Nicolaus. Thomas Kouchoukos - Stifel, Nicolaus & Co., Inc., Research Division: Let's say I guess on tomo, you guys actually -- I think you provided a lot more of the metrics that I think people have been asking about. One question, and we appreciate that. One question I have is just looking at your mix of 2D, 3D systems as a whole, I don't know if you can provide an actual number, but maybe you can give us some sense of when a customer buys 3D or upgrades to 3D, how many machines are you selling out there that's kind of every day encapsulated in one versus maybe some of them that bought a 2D system last year and just decided to upgrade to 3D?

Glenn P. Muir

Analyst · Goldman Sachs

Yes. I think let me start with that question, Tom. I think there's I guess 2 questions there. One relates to Dimensions in general and what percent of total sales that we're seeing today and it is substantial. Over 60% of our units now of digital mammography are of the 2D, 3D Dimensions. And then to further break that down, the 3D comes in 2 pieces. One is a complete system sale as part of Dimensions and secondarily, as part of an upgrade to an already existing unit. So first of all, most of our 3D tomo sales are in fact of a complete system. And we are seeing the tomo upgrades to that installed base, but it's a much smaller number than the initial full bodied 3D going out the door. At the same time, the rationale for most people on moving to the Dimensions platform is to add 3D over time. So our expectation would be to see those software upgrades kicking in the future, probably at a point in time where we get better traction or visibility on a, the reimbursement and b, the clinical evidence, the publications in the marketplace supporting the clinical utility of tomo itself. Thomas Kouchoukos - Stifel, Nicolaus & Co., Inc., Research Division: Okay. That's very helpful. If I could follow-up one quickly on your Adiana CE mark. One, I just wonder how important is radiopaque to the product and then what does that mean for FDA approval in terms of the process that you would have to go through?

Robert A. Cascella

Analyst · Goldman Sachs

Sure. We think obviously radio cadence is an improvement. It's an evolutionary improvement for the product. We think that, that will be important, both for our international sales and here in the States. We're in discussions with the FDA around radiopaque at this point in time. So it is unclear as to what the approval timeline would be for that product.

Operator

Operator

And we'll now go to David Lewis from Morgan Stanley.

David R. Lewis - Morgan Stanley, Research Division

Analyst

Glenn, first question on leverage, I wanted to come back to it. If I basically look at the impact that DTC had on your SG&A spend for 2011 and then think about 2012, I guess I'm surprised to see you growing SG&A pretty close to in line with revenue. Can we walk through some other components that are driving that? Or do you plan on spending more money on DTC than you were spending in 2011?

Glenn P. Muir

Analyst · Goldman Sachs

Yes, well there's a couple of good questions in there, David, One having to do with DTC, and maybe I could just start to answer the DTC one first. And our initial program for DTC was over a 15-month period to allocate approximately $20 million to that program. And we're about 12 months into that program. So we've already spent close to $15 million in DTC, and we are getting a return. And it has been a positive return but as Rob indicated, not anywhere were we had hoped it would be. But at the same time, we're still seeing some of the benefits from that awareness and do expect that to also present itself in FY '12 for the first half of the year. So we're still expecting to see a continued growth in NovaSure directly related to that DTC. Now will we continue to spend at this level in FY '12? No, we won't at all. I mean a lot of that awareness is out there today and we will maintain some of the expenses to keep it going. But it will be nowhere near the level that we spent in FY '11. So then the question is where's the leverage on the SG&A side if we're not spending on DTC? And a big part of that is being taken up by the new products, the 3 acquisitions and the expenses associated with those 3 acquisitions and growing their particular market or their particular territory. So we're kind of shifting resources from the DTC to new products that we believe will help grow the top line revenue. Our revenue guidance going into the year, as I've said, was about 6% to 7% for FY '12 over FY '11. But that is basically where our breakeven is. Our breakeven on leverage is about 6% revenue growth. But I think there's a lot of upside if we think about the 3 segments and the potential in those segments. Within Breast Health, we have the upside conceivable from tomosynthesis kicking in. In the GYN Surgical, it's MyoSure. And within Diagnostics, it's both Cervista HPV and it's the TCT efforts in China. So there's a lot of positives as we look forward into FY '12. But you're correct, we have to move that revenue needle up beyond 6% to get real leverage in the business. At which point, I think we'll get pretty significant leverage. But it's still early for the year and it is still -- our guidance, I think, does reflect that it's early in the year for us to make that revenue projection.

David R. Lewis - Morgan Stanley, Research Division

Analyst

And Rob, just a quick follow-up here. Ever since our model Diagnostics seems to be driving more of the upside. But I actually had a question on surgical. Just considering the trends we saw with NovaSure this particular quarter, and you're still sort of guiding to upper-single digit surgical business, it does imply probably a bigger number for MyoSure than I guess we had in our model. Maybe just talk to us about your confidence that NovaSure can trough and rebound throughout the balance of the year and your confidence that MyoSure can make up the difference.

Robert A. Cascella

Analyst · Goldman Sachs

We obviously do think, I think highly of the MyoSure product and the potential for it, David. So there is a component of that growth that's being related to it. Obviously we express it as a business segment versus this product line. And we have to say, there's a growth element in Adiana, and there's a growth element in NovaSure. So between the 2 kind of legacy products, if you will, and the addition of MyoSure, that's really where the upper-single digit growth number came from.

Operator

Operator

We'll now go to Bill Quirk from Piper Jaffray.

William R. Quirk - Piper Jaffray Companies, Research Division

Analyst

Two questions for me. First off, Rob, a little color on the OUS mammography business. You obviously talked at length about the U.S. side, but curious to see what the trends are there.

Robert A. Cascella

Analyst · Goldman Sachs

Sure. I'm going to have David Harding chat about that with you. David?

David P. Harding

Analyst

We continue to see very good adoption of both our base Selenia business and our Dimensions business in a wide variety of places all across the world. We saw a pretty dramatic uptick in Europe despite all of the headwinds in the Southern European countries. We saw good growth in Asia. We saw good growth in Latin America and also in Australia and New Zealand, as well as in the Middle East and South Asia. So really across the entire world, we are seeing new countries come on board with Dimensions, both tomo and 2D, while we continue to penetrate I guess the lower end of the market with our Selenia units. So we're very, very excited about the growth there and saw a good strong double-digit growth in virtually every market across the world.

William R. Quirk - Piper Jaffray Companies, Research Division

Analyst

Very good. And then just thinking a little about Cervista and now that we have another competitor on the market, we've had some accounts, I think, they've been waiting to see the fourth one enter. Now, our diligence suggests we could be seeing a number of different valuation protocols at this point. Rob, any comments here about how you think about this franchise going forward? Any changes to competitive positioning, et cetera?

Robert A. Cascella

Analyst · Goldman Sachs

Well sure. And as we've stated earlier, our strategy thus far has really been to segment the market and go after the low to middle tier. We think our product, our assay, is most appropriate for that segment of the market. I think with the approval, the pending approval in HDA, we do think that, that changes the game a bit, and we believe that we would be better positioned to go after a larger segment of the market as well. So I think where this is going to shake out is that there's not going to be one company that prevails in this battle for HPV, and it's going to be software companies buying for share and the upper tier of the market is going to get a bit crowded. And I think that the load at the mid-tier of the market may be a place that we can excel. And that's where we approve, and that our product is appropriately positioned. So we'll certainly continue to exercise that while we duke it out at the upper tier of the market with the other 2 entrees.

Operator

Operator

We'll now go to Nandita Koshal from Barclays Capital.

Nandita Koshal - Barclays Capital, Research Division

Analyst

I guess my first question is could you talk about what proportion of tomo you have today are reimbursed in an amount over say a minimum $20? And you sort of gave us that range of $30 to $70 but what does the average look like?

Robert A. Cascella

Analyst · Goldman Sachs

The average is probably somewhere near your $40 to $50. And it's early on, so we want to be clear about that. But it's encouraging and what this does is establish a value to the tomo portion of the exam. And that's where this is going to be useful for when we do finalize a permanent reimbursement solution. So I want to caution that we don't believe this is a long-term solution. It is a way for our customers to have an interim solution that we then can also use to establish value when a permanent solution is derived.

Nandita Koshal - Barclays Capital, Research Division

Analyst

Okay. That's very helpful. And Glenn, if you could help us with the margin outlook for the Breast Health segment next year, how does the service versus the instrument, versus the software upgrade piece play out? And what are the expectations baked in around that in your guidance right now?

Robert A. Cascella

Analyst · Goldman Sachs

Sure, I'll give you kind of a rough sketch and hopefully, this will make sense and it's one of the reasons why we've had detailed a bit more about service as well was that if you look at the business, what we see is that there's going to be some margin improvement that is going to be fueled by a higher quantity of tomo systems sold. So even the complete gantry, inclusive of tomo and not just the standalone software upgrade, we'll have attractive margins. That will drive the business relative to a gross margin improvement. Now partial offset maybe the -- as service revenues slow, there can be a negative impact on margins as a result of that. But overall, we think that the margins for Breast Health will be favorable for the year.

Glenn P. Muir

Analyst · Goldman Sachs

Let me also add to that, if I could. Rob is absolutely right on. Breast Health as we know, because of the capital equipment nature of that business, is our lowest gross margin segment. The Diagnostic and disposable units provide gross margins in excess of 60%. So the corporate average is 61%, 62%. So within Breast Health, where we currently are today, it's in the -- just over 51% with gross margins. And I think if we look in FY '12, we're looking for upside to that gross margin as revenues continue to increase in that segment, which really helps in our overhead and our allocation. And it's really being driven by the revenue increases we see from some of the higher gross margin products. And that would be the 3D tomo. And in the future, as these 2D Dimensions are being placed in the marketplace, if we get to the point where 3D becomes accepted as the standard of care, it will be at that point in time where we see the software upgrade to 3D tomo happen to what might be a side of installed base at that point in time. And once again, it's all about reimbursement and the clinical evidence. But at that point, we would get the software upgrade, and that software upgrade is a 95% plus gross margin component. So I think the outlook for FY '12 is very positive, I think directionally for that gross margin within Breast Health because of the expected revenue increase and the product mix moving to tomosynthesis.

Operator

Operator

We'll now go next to Rich Newitter from Leerink Swann.

Richard Newitter - Leerink Swann LLC, Research Division

Analyst

Just 2 quick ones. One, since you're talking about the leverage being very much predicated on revenue growth acceleration perhaps relative to your initial forecast, can you help me understand some of the underlying baseline assumptions, for example, behind your GYN Surgical unit? What are you assuming in terms of any kind of market pickup? What more precisely are you thinking in terms of growth in NovaSure versus MyoSure and Adiana? And what's the baseline and what would constitute upside that could give us that leverage?

Robert A. Cascella

Analyst · Goldman Sachs

I think we're trying to stay a little bit away from the product line by product line, but I will say this that it may help is that as we look at obviously NovaSure and any of the other business in surgical, we are looking for some level of a recovery or at least stabilization in that market. And we are anticipating that. And there is some of that, that is reflected in our plan. In addition, we've added a significant number of salespeople to provide better coverage so that we can seize the opportunity going forward. So that the growth thought is one of a bit of a stabilization in the economy over the course of '12 that really gets complemented by a broader sales force that are a bigger footprint relative to our coverage.

Richard Newitter - Leerink Swann LLC, Research Division

Analyst

So is it safe to characterize maybe even your overall sales assumptions as a stabilization in 2012 with any improvement really to provide upside to your preliminary projections?

Robert A. Cascella

Analyst · Goldman Sachs

I think we feel more about that impacting surgical than I would say the other businesses. I think that we see a stabilization in our domestic Diagnostics business, growth with HPV, stabilization with ThinPrep. I think the capital equipment business, as I said in my opening comments, is really a different animal and that is that it would be fueled by new technologies so the replacement cycles will lengthen them, unless fueled by something that's exciting. And we believe that tomo fuels the replacement of existing mammography equipment. So fortunately or unfortunately, there is no one answer for our 3 businesses because the 3 primary segments, because they are dramatically different. And it's really the surgical business that is most directly impacted by the sluggish economy today. And again, the reasons we gave in our opening comments and that is that it is, it is not a life-threatening procedure. It does carry a very high co-pay and a very high deductible. And as a result of that, it is much more susceptible to the economic woes than some of the other businesses are today.

Operator

Operator

Our next question comes from Isaac Ro with Goldman Sachs.

Isaac Ro - Goldman Sachs Group Inc., Research Division

Analyst · Goldman Sachs

Wanted to follow-up on that last question from Rich regarding your assumptions for the utilization trends on the surgical side next year. I mean if I look back qualitatively during earnings season, it does feel like sequentially the trends here across other companies have not materially improved. And for sure, some of the items in surgical this quarter regarding the acquisitions of MyoSure and so forth, it does feel like the trend there is reflective of that bigger picture. So I'm just wondering what leading indicators do you have that give us some confidence around your expectations for stabilization in surgical next year?

Robert A. Cascella

Analyst · Goldman Sachs

So I think what we tried to build into the plan, I think, is really it's a bit of a conservative approach but one that is also reflective of the fact that we've added 30 sales people. So we have a brand-new product, which has a lot of leg room for growth, and that is MyoSure. And in addition to that, we've come off of a low with NovaSure, now complemented by the trailing of DTC and another 30 sales heads. But we get much better coverage just as a result of those 2 elements. So when we look at it, certainly there's no way to predict with absolute certainty where the economy's going relative to unemployment or the like, but we also believe that we hedge that with better coverage and a better emphasis on converting the leads that we're now getting out of DTC versus just focusing on awareness.

Isaac Ro - Goldman Sachs Group Inc., Research Division

Analyst · Goldman Sachs

That's helpful. And then maybe secondly for Glenn on the use of balance sheet. You mentioned the preference is sort of steer clear of buybacks, could you maybe help put that in context? I mean obviously asset prices for med tech have come down over the last year. And so maybe in that setting, you can argue that valuations are more attractive for [indiscernible] candidates. I'm just wondering if that's the main reason why you're keeping it to having more dry powder? Or are -- you sort of have a stronger reason why you don't want to be buying back your stock at these levels?

Glenn P. Muir

Analyst · Goldman Sachs

No. I think there isn't -- it really has nothing to do with the desire to buy back the stock. I think we all would like to buy back the stock. But we only have limited cash flows as it is. And I think it's a healthy level. And at the moment, as we look forward into the year, I think there will be opportunities that can drive a greater return and provide us with additional revenue and earnings expansion. If we didn't see and didn't believe that the opportunities, I think we'd feel differently about it, but we think there are. If they don't materialize, I mean we're not in a rush and we're not going to do anything silly. If they don't materialize, we would like to deleverage a little bit. So the dollars on the balance sheet might simply be reallocated to lowering that debt level. And we're always looking at stock and considering a buyback. And in the future, we may in fact consider it. But I think at the moment, we're comfortable with where we are.

Operator

Operator

And we'll now go to Jonathan Block from SunTrust.

Jonathan Block - SunTrust Robinson Humphrey, Inc., Research Division

Analyst

The first question, and my apologies if I missed it, but just the backlog number at the end of the quarter and how that compares to the previous quarter?

Glenn P. Muir

Analyst · Goldman Sachs

Yes. The backlog was $264 million at the end of the quarter. It was down $20 million or so from Q3. There is nothing special about that. Our backlog is no longer reflective of our business. It's a combination of capital equipment orders, which I would say is reflective of our business. But it gets masked by all these bulk orders and one-year commitments that we get on the Diagnostics side. And it's very hard to really peel away what's really going on. The way to look at it is backlog's fairly steady, and it's really no longer a good proxy for what's going on in the business. That's too much disposable Diagnostics stuff that's kind of in there.

Jonathan Block - SunTrust Robinson Humphrey, Inc., Research Division

Analyst

Yes. I understood. I was just hoping to see if it was strong or down q-over-q. And then, Rob, for you, interesting comments on NovaSure. You've done a lot of work there. I just want to make sure I'm understanding this. The rough math, if I take a step back and I think you believe the direct consumer contributed an incremental $20 million to your U.S. NovaSure sales. So if I just exclude that amount and look at what your results would have been x the DTC, you believe the ablation business here in U.S. is down 10% plus in 2011?

Robert A. Cascella

Analyst · Goldman Sachs

Yes. I think what I stated was that that's our ablation business. As I indicated, it's really a combination of there's market erosion due to some of the economic factors that I gave. But I also believe that we lost share. I believe that we lost share when we introduced MyoSure, and we got distracted relative to training, having a brand-new product in the field. And that is one thing that we are working towards to recover. And then in addition to that, I think there were some non-GEA competition that we would categorize as delaying the uptake in sales. So the combination of those 3 factors, economy, GEA, competition and non-GEA competition led to really offsetting nearly all of the growth that we think we got out of our DTC program.

Operator

Operator

And we'll now go to Sara Michelmore from Brean Murray. Sara Michelmore - Brean Murray, Carret & Co., LLC, Research Division: It does strike me that the kind of main swing factor here in the forecast is the trajectory of the digital mammography business. So I'm just wondering if you can talk through the visibility you have on that and kind of how you thought about building up your forecast, et cetera? Just anything that could give us kind of some sense of your confidence level in terms of how that is going to shake out. And if this is the best case scenario that could potentially be exceeded?

Robert A. Cascella

Analyst · Goldman Sachs

Yes, I think -- this is Rob. I think when we put together our plan, we went back and we looked very deeply and seriously at the numbers that we gave out earlier about that 500 to 700 unit forecast that we thought was pre-reimbursement and as I said last quarter and I would say it again, that we feel very good about that. And that was comprised of a subset of what we think are early adopters. And there maybe early adopters from a research perspective, or they maybe early adopters from an early commercial perspective, and the reason why they want the technology is to market the benefits of it. So between those 2 elements, we think that, that carries the product through this pre-reimbursement phase. Longer term, that is not going to happen obviously. We need a permanent reimbursement in order for there to be sustained growth in tomosynthesis, and we feel very confident that as we move into fiscal '13 that happens. So as far as our numbers for '12, we feel good about them or they would not have been in our plan at this point. Sara Michelmore - Brean Murray, Carret & Co., LLC, Research Division: Okay. And then those types of customers that are really the commercially typed that you talked about, I mean can you give us just a little bit of color about what their plans are? What you've seen in terms of marketing? Are there any kind of regional areas that are hot, et cetera?

Robert A. Cascella

Analyst · Goldman Sachs

I think it really is not so much regionally as it is about the profile of the site. And there are some very commercially oriented sites that look at tomo as a way of marketing, a bit of the sizzle behind the technology relative to its FDA claims, relative to the significance with respect to improved results and outcomes and so on and so forth. So they, I wouldn't want to -- I don't think that it is geographically focused. I think it's much more about profiling the right kind of sites and these are typically multiunit sites that are quite frankly in the business of diagnostic imaging. Sara Michelmore - Brean Murray, Carret & Co., LLC, Research Division: Okay. And then just one last quick one on ThinPrep, just a clarification. So it does sound like most of the growth was from TCT, although you said the volume growth was up 11% as well. So I'm just wondering what the kind of volume price dynamic was in the U.S. part of that business?

Robert A. Cascella

Analyst · Goldman Sachs

It's a great question, and I wanted to clarify that we already have the TCT volumes. So incrementally, the volume irrespective of TCT for ThinPrep is up 11%. We actually see other than things like further consolidation in the U.S. market, which has the tendency to bring pricing down because of larger labs buying smaller. There does not seem to be a tremendous amount of downward pressure on pricing here in the States. As we branch off into new more emerging markets in different parts of the world, pricing is lower. But that is -- the dilemma there is once you've walked away from the business, or do you garner the business, but at a lower gross margin at a lower EUP. We have opted to go after that business because something is better than nothing at that point.

Operator

Operator

And we have one time for one further question, and that question comes from Bill Bonello with RBC.

Bill Bonello - RBC Capital Markets, LLC, Research Division

Analyst · RBC

Just one more follow-up on the Dimension. Can you give us a sense that the customers that have been ordering Dimensions, sort of how that's coinciding with sort of capital equipment purchasing calendars? In other words, are most of the people into a fiscal '12 calendar? Or is that something that could be a catalyst for additional purchases as we look forward?

Peter Soltani

Analyst · RBC

Sure. This is Peter. I can answer that. Yes, the timing of the approval is certainly sort of mid-year and completely out of phase with the capital cycle. So yes, I think we will see a more planned approach to purchases going into FY '12 for the buyers.

Bill Bonello - RBC Capital Markets, LLC, Research Division

Analyst · RBC

So is it safe to say that the people who have been getting systems thus far are essentially people who were scrounging around and still able to find dollars midyear?

Peter Soltani

Analyst · RBC

I think to some degree, that's probably true.

Bill Bonello - RBC Capital Markets, LLC, Research Division

Analyst · RBC

Okay. And then just one follow-up, which is in terms of the customers looking for more clinical data, customers that would want to wait for more clinical data before adapting, to what extent do you think the kind of data we're going to see at RSNA can be a catalyst on that front?

Peter Soltani

Analyst · RBC

Well of course we don't control the content of what the investigators are going to present at RSNA. But certainly, just to read into the abstracts and based on what we at least we think we know of what they might present, the data that we're seeing, it looks very, very strong. Certainly anecdotally, we see great results from our commercial sites, clinical sites. So we feel pretty strongly that this will be a very important arsenic for those who are interested in getting that really strong clinical assessment as to whether or not some are always in fact for real.

Operator

Operator

Thank you. That is all the time we have for questions today. This now concludes Hologic's Fourth Quarter and Fiscal 2011 Earnings Call. Have a great evening.