Hologic, Inc.
Q4 2012 Earnings Call Transcript

Published: 13 Nov 2012

[Operator:]

Good afternoon, ladies and gentlemen, and welcome to the Hologic Inc. Fourth Quarter and Fiscal Year 2012 Earnings Conference Call. My name is Kelsie, and I am your operator for today's conference. Today's conference call is being recorded. [Operator Instructions] I will now turn the conference over to Deborah Gordon, Vice President, Investor Relations. Please go ahead, Ms. Gordon.

[Deborah R. Gordon:]

Thank you, Kelsie. Good afternoon, and thank you for joining us for Hologic's Fourth Quarter and Fiscal 2012 Earnings Call. The replay of this call will be archived on our website through Friday, November 30, and a copy of our press release discussing our fourth quarter and fiscal year results, as well as our first quarter and fiscal 2013 guidance is available on the Overview section of the Investor Relations page of Hologic's website. Also in that section is the PowerPoint presentation related to the comments that will be made during today's opening remarks. Before we begin, I would like to inform you that certain statements made by Hologic during the course of this call may constitute forward-looking statements. These statements involve known and unknown risks and uncertainties that may cause the actual results to be materially different from any future results implied by such statements. Such factors include those referenced in our Safe Harbor statement in our fourth quarter fiscal 2012 earnings release and in the company's filings with the Securities and Exchange Commission. 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 also be found in our fourth quarter earnings release, including the financial tables in the release. Please note, today's call will consist of 30 minutes of opening remarks followed by a 30-minute Q&A session. [Operator Instructions]. Lastly, I would like to remind you of our upcoming investor meeting at RSNA in Chicago, during which we will discuss tomo from a commercial and an economical perspective. The event will take place on Tuesday, November 27, beginning at 8

[Robert A. Cascella:]

Thanks, Deb. Well, good afternoon, and thanks for dialing in to our fourth quarter call. Joining me on the call today are Glenn Muir, our Executive Vice President and Chief Financial Officer; Carl Hull, General Manager of our Diagnostics business; Peter Soltani, General Manager of our Breast Health business; and David Harding, General Manager of international operations. Today, I'll summarize our fourth quarter performance. I'm also going to update you on the integration of Gen-Probe, including our expectations for synergies, review the market adoption of our Dimensions 3D tomo system and provide a brief review of some of the other key businesses. Glenn will then give you a financial review in greater detail and introduce you to our first quarter and fiscal 2013 guidance. We'll then open up the call for 30 minutes for Q&A. So from a quarterly performance perspective, total revenues, including 2 months of Gen-Probe, increased 28.5% to $600 million on a non-GAAP basis. Excluding the revenue contribution from Gen-Probe during the quarter, legacy Hologic revenues were $499 million, which exceeded our guidance of $485 million and represented growth of 7% on a year-over-year basis. Our revenue outperformance was fueled by growth in all 4 business segments

[Glenn P. Muir:]

Thank you, Rob. Consolidated revenues of $600 million this quarter are on an adjusted non-GAAP basis and includes Gen-Probe revenues of $101 million for the 2 months following the acquisition. To further explain, these revenues include $11.6 million for Gen-Probe's share of product used by end-use customers of Novartis in the quarter. Gen-Probe has a collaboration arrangement with Novartis whereby Gen-Probe receives a portion of the Novartis revenue for screening blood donation. Under a GAAP and purchase accounting, we treated all inventory at Novartis at the time of the acquisition as unbilled receivables and recorded them at fair market value on August 1. The Novartis customers subsequently used the product to screen donated blood this quarter, entitling us to our share. Since this amount had already been recorded in purchase accounting, there was no revenue to recognize. We believe adjusting revenue gives a more meaningful measure of Gen-Probe's true sales in the quarter and is consistent with historical practice. Year-over-year, foreign currency had a $6 million unfavorable impact on consolidated revenues or a reduction of 130 basis points. On a constant-currency basis, total growth was approximately 30%. Excluding Gen-Probe revenues, Hologic's organic growth rate in constant currency terms was approximately 8%. As expected, the extra week in this year's fourth quarter had no impact on our capital equipment business and had a bit more of an effect on our service and disposables product line. Although the exact effect is difficult to quantify given the inherent nature of our sales patterns in the last week of any quarter, we believe it was less than $5 million. Even though this extra week contributed in part to the revenue growth, we didn't see a corresponding EPS increase primarily because we absorbed a full week and disproportionate share of extra expenses. Now turning to our operating segment. With the Gen-Probe acquisition, Diagnostics is now our largest segment and represented 44% of total company sales for the quarter. Year-over-year revenues increased $114.6 million or 76.1%. On a constant-currency basis, the increase was 77.5%. Even excluding Gen-Probe, this segment was the largest contributor to consolidated revenue growth, with revenues increasing $13.5 million or 9% and 10.4% year-over-year on a constant-currency basis. So in summary, a very good quarter for our Diagnostics segment. Looking at Hologic's legacy Diagnostics business first, consistent with the prior quarter, almost 3/4 of this segment legacy growth came from our core Diagnostic products, primarily from ThinPrep, with the balance coming from our Molecular Diagnostic product line. Worldwide ThinPrep test volume increased to a new quarterly record, and revenues increased 6% year-over-year and 3% sequentially. International sales continue to drive the majority of our year-over-year ThinPrep growth, most notably sales by our [indiscernible] key subsidiary in China, which once again had strong performance. We also continue to see steady pockets of growth from the Rest of the World, mainly in emerging market. We saw a strong performance again this quarter from our Molecular Business led by our HPV products. Globally, we experienced over 20% revenue growth in our 2 Cervista HPV lines, as well as in our Molecular Business overall driven by double-digit increases in U.S. and international market. Turning to Gen-Probe results for the 2-month period, adjusted revenues were $101.1 million and were in line with our expectation. Clinical Diagnostics revenues were approximately $70 million, with the APTIMA STD products being the largest contributor. Blood screening revenues were approximately $31 million. Due to the unique 2-month stub period, we do not have year-over-year reported numbers for comparison. However, we can tell you that both of the 2 primary segments were up on a year-over-year basis, and the trends seen during this period are expected to continue and therefore are factored into our fiscal '13 guidance. Going forward, Gen-Probe has been incorporated into our Diagnostics segment, and there'll be no separate Gen-Probe segment to compare to prior quarters. Instead, we will be speaking qualitatively about the key product contributors. Breast Health revenues increased $11.2 million or 5.1% from last year and represented 38% of total sales. On a constant-currency basis, the increase was 6%. Total segment revenue growth was driven primarily by an increase in service revenues of 14.5% while product revenues were up slightly compared to last year and 9% sequentially. Product revenues on the mammography side were down slightly year-over-year as expected due to both the ongoing shift to our Dimensions product lines from our legacy Selenia and economic weakness in international markets that resulted in lower sales. However, [indiscernible] on a sequential basis, mammography product revenues grew nicely in the low double digits. Segment revenues also benefited from our breast biopsy line again this quarter, specifically Eviva, which grew almost 30% year-over-year. Overall, we were particularly pleased with the Breast Health product revenues in the fourth quarter, which were the highest since the second quarter of fiscal 2008. Digital mammography product sales and associated service revenues represented 66% of the segment's revenue, with sales and service each contributing equally. Looking closer at digital mammography product sales, results were driven primarily by our Dimensions line, which represented 79% of worldwide digital mammography revenue and 66% of units this quarter and were significantly higher than 1 year ago. Fourth quarter sales benefited somewhat from the delayed U.S. shipments of 3D tomo's in backlog at the end of Q3, but strong Q4 orders resulted in a 17% sequential increase in the 3D tomo backlog. Worldwide 3D upgrade units increased 45% year-over-year and 12% sequentially and represented almost 25% of total tomo unit sales and almost 10% of tomo revenues. We continue to believe that over time, all 2D Dimensions sold will be upgraded to 3D, and as such, upgrades remain an important contributor to 3D tomo adoption. Our GYN Surgical segment reported a $5.7 million increase in revenues or 7.7% year-over-year and 8.2% on a constant-currency basis, driven by strong MyoSure sales and positive NovaSure growth partially offset by the reduction in Adiana sales. Excluding Adiana revenues in both periods, GYN Surgical increased $12 million or 17% year-over-year. Improving NovaSure volumes in both the U.S. and international markets contributed to worldwide revenue growth of 3.4% and the first quarter of year-over-year increase since Q3 of fiscal 2011. MyoSure was the segment standout again this quarter, posting triple-digit sales growth and another quarter of record revenues. Total legacy Hologic international sales grew 10% on a constant-currency basis, and with the addition of Gen-Probe, we're up 35%. International sales represented 25% of the total company revenues compared to 25% last year and 27% last quarter. Sequentially, the international sales mix declined slightly due to the typical softness in Europe during the summer months. Next, a brief review of fourth quarter performance on the rest of the P&L. Non-GAAP gross margins were at 62.2%, up 30 basis points year-over-year, up 20 basis points sequentially and within our guidance range. All 4 segments posted higher gross profit dollars in the fourth quarter in 2 segments, Breast Health and GYN Surgical posted higher gross profit margins compared to last year. Total Diagnostics gross margins declined 470 basis points, primarily due to mix shift and certain one-time service and manufacturing costs in the legacy Hologic business and, to a lesser extent, from the contribution of Gen-Probe since close. We were pleased with the improvement in GYN Surgical gross margins of 310 basis points due primarily to the favorable mix shift from Adiana to MyoSure devices. Non-GAAP operating expenses increased $43 million or 30% to $186.6 million. Excluding Gen-Probe expenses, Q4 operating expenses increased $10.6 million or 7.4% to $154.1 million compared to $143.6 million last year. The increase in operating expenses was driven by higher variable costs consistent with the higher revenues. Our non-GAAP adjusted net income increased $9.5 million or 10.7% to $98.3 million this quarter and operating expenses were 31% of sales, the same as the prior year. Non-GAAP EPS was $0.37 this quarter, with Gen-Probe adding $0.01 of accretion. Legacy Hologic EPS was $0.36, at the high end of our guidance range of $0.35 to $0.36. For the full year of fiscal 2012, we reported non-GAAP revenue growth of 12.6% over fiscal 2011 or 13.2% on a constant-currency basis. Excluding Gen-Probe revenues, fiscal 2012 organic growth was 7%, and all 4 operating segments posted positive growth. On a non-GAAP basis, fiscal 2012 gross margins were 62% versus 61.7% a year ago and in line with our guidance of 62%. Operating expenses on a non-GAAP basis increased 12% year-over-year, representing 31% of total sales, consistent with prior year in the quarter. The increase in operating expenses was driven primarily by our acquisition of Gen-Probe. Excluding Gen-Probe, operating expenses increased 6% year-over-year to $595 million, slightly higher than the top end of our guidance range of $590 million but below our fiscal 2012 organic sales growth rate. Non-GAAP adjusted net income increased 10% year-over-year to $367.8 million or $1.38 per fully diluted share. Excluding Gen-Probe EPS was $1.37, which was in line with our guidance range of $1.36 to $1.38 and higher than last year's $1.27 per diluted share. We continue to generate strong free cash flows and ended our fiscal year with a cash balance of $566 million, down approximately $147 million from the end of fiscal 2011 due to our acquisition of Gen-Probe. Working capital management and continued strong results from operations in fiscal 2012 generated over $400 million in operating free cash this year. Our strong balance sheet profile combined with attractive long-term financings allowed us to fund our acquisition of Gen-Probe. Total debt obligations for the company at fiscal year end total approximately $5.2 billion resulting in a ratio of total debt to EBITDA of approximately 5.1. This includes a $3.5 billion in debt we borrowed to acquire Gen-Probe. As indicated at the time we announced the acquisition, our goal is to reduce this ratio to 2.5 over the next 3 years or by the end of our fiscal 2015. Debt reduction will be funded by the strong operating free cash flow the combined company will generate over this period, and for fiscal 2013, we estimate operating free cash flow will be approximately $600 million. Given our historic cash flow generation coupled with Gen-Probe, we will remain confident we will achieve this goal. For purposes of your model and cash flows and the interest expense, I would like to remind you that our initial focus for debt pay-down during fiscal 2013 is on the $775 million tranche of our convertible notes that are expected to be put to the company in December of 2013, as well as the $65 million in scheduled principal payments for our tranche A and B of our term loan. This obviously requires a substantial amount of cash, so we plan to build our cash balance through fiscal 2013 and in fiscal 2014, focus on starting to pay down the remaining $3.5 billion in debt we borrowed to fund the Gen-Probe acquisition. Now moving on to guidance. We fully detail our guidance expectations in our Q4 earnings release in our supplementary PowerPoint presentation, both of which are posted on our IR website. The company's guidance reflects current operations, including revenues from our approved and cleared products and recently acquired businesses. For Q1 of '13 ending on December 29, we expect non-GAAP revenues of $640 million to $645 million, representing year-over-year growth of 35% to 36%. This guidance excludes an expected purchase accounting reduction of $17 million related to our Novartis collaboration, which I explained a few minutes ago. Our guidance assumes constant currency rates with Q4 of FY '12. The inclusion of Gen-Probe for a full quarter, the continued ramp-up of new products including the Dimensions and MyoSure systems and an overall strengthening in each of the company's operating segments, these increases are partially offset by a reduction in revenues related to Adiana, which had an approximately $5 million in revenues in the first quarter of fiscal 2012. This guidance also reflects our expectations that year-over-year, Breast Health will grow in the mid single digits; Diagnostics revenues will double from last year's legacy Diagnostic revenues; GYN Surgical, we will grow in the low single digits; and Skeletal Health will grow in the low single digits led by mini C-arm sales. On a non-GAAP basis, we expect gross margins of approximately 62.5% to 63%. Operating expenses to increase on a sequential basis to $195 million to $200 million or approximately 30% to 31% of revenues, primarily due to the inclusion of Gen-Probe's operating results for a full 3 months, a general ramp-up due to increased revenues and the seasonal increase related to trade shows, RSNA and our national sales meetings. Interest expense is approximately $55 million. This includes the additional interest related to the financing of Gen-Probe. We expect an effective tax rate of approximately 34% and $270 million of diluted shares outstanding for the quarter. All of these results in non-GAAP EPS of approximately $0.37. For fiscal 2013, which ends on September 28, we are introducing guidance for non-GAAP revenues of $2.61 billion to $2.64 billion. Year-over-year, this represents an expected increase of 30% to 31% over fiscal 2012 revenues of $2.01 billion. This guidance excludes an expected purchase accounting reduction of $22 million related to our Novartis collaboration and primarily reflects an increase in revenues related to our acquisition of Gen-Probe, mid-single-digit growth coming from each of our Breast Health, GYN Surgical and Skeletal segments. Our guidance also factors in a reduction in revenues related to Adiana, which totaled $11 million in fiscal 2012. On a non-GAAP basis, we expect gross margins to be approximately 62.5% to 63%. The key drivers of future margin improvement are the expected revenue increases and the addition of the higher-margin Gen-Probe Molecular Diagnostic products; operating expenses to increase at $775 million to $800 million or approximately 29% to 31% of revenue, primarily due to the inclusion of Gen-Probe's operating results for our full year; and, to a lesser extent, a general ramp-up due to higher sales. In addition, we are expecting to incur approximately $25 million related to the medical device excise tax beginning on January 1, 2013 and to record this charge at the general and administrative expense. Interest expense to be approximately $220 million, and this includes the additional interest expense for the financing of Gen-Probe. An effective tax rate of 34% and $272 million of diluted shares outstanding for the year. All these results in non-GAAP EPS of approximately $1.56 to $1.58, which implies growth of 13% to 14% year-over-year. This EPS guidance includes the impact of the medical device excise tax, which we expect to be $0.06 diluted. In closing, we are pleased with our fourth quarter and ended the fiscal year on an improving trend. Our acquisition of Gen-Probe this year marks a key inflection point in the company's history. We are well positioned for future growth, fueled by 2 compelling new product cycles, tomo and PANTHER, and our 2 largest business segments, Diagnostics and Breast Health. We expect fiscal 2013 to be notably strong relative both to our historical operating and financial performance and to our Medtech peer. Our guidance includes solid top-line growth, improving margins and strong financial leverage from synergies and debt pay-down. And with that, let me turn the call back to Rob.

[Robert A. Cascella:]

Thanks, Glenn. Look, in closing, this business clearly has many moving parts. Some of it that are in our control and others that are not. It's difficult to have a conversation these days without some reference to the shape of the global economy and what impact it's going to have on our business next year. With the results of the recent presidential election, we know one thing for certain. We have a device tax absorbed within our cost of operations. There's a promise of expanded coverage for the uninsured and the potential of millions of new lives entering the healthcare system, but it is unclear how this will be implemented. I do believe our products are well suited for Health Care Reform in the U.S. since our predominant focus is wellness and prevention. With all of these unknowns, the lack of clarity about the near to mid-term healthcare environment, we have taken a more conservative view with our guidance and the managing of our business. Fundamentally, we continue to emphasize 3 strategic elements for growth, organic growth fueled by our expanded product portfolio, significant product development across all of our business units and continued investment in our international expansion. Our priorities today are very clear

[Operator:]

[Operator Instructions] Our first question will come from Ross Muken with ICI (sic) [ISI].

[Vijay Kumar:]

This is Vijay in for Ross. So maybe first question on the Breast side, Rob. So could you just give a little bit color on the backlog? It was really strong, up 17%. And put that in context, given that you expect the reimbursement code to be now pushed out sort of. What gives you the confidence, I guess, despite the delay in the push out of this reimbursement code given the macro environment to see this strong growth in backlog and interest in tomo?

[Robert A. Cascella:]

Well, we -- the backlog increase is a reality. We did see that as a result of strong order activity in Q4. I think the real question about reimbursement and what impact that will have on our product is one of really timing. And what I mean by that is I still believe we are at the very early phase of market adoption. And as a result of that, the buyers that are interested in tomo today are buying it because they believe in the technology, they believe that there's a competitive advantage within their local community. And as a result, they're almost being forced to buy the product. I think for much broader adoption, when we talk about 10,000 digital units eventually converting to 3D mammography, that will require reimbursement in order for that level of adoption. So yes, it is certainly a complication that reimbursement is delayed. We don't think that, that material impact is what happened this year. If the U.S. economy changes dramatically, because of either our Health Care Reform or otherwise, it's not going to be because of reimbursement that there'll be headwinds on that product. It will be much more that those capital -- general capital equipment freeze.

[Vijay Kumar:]

Great. So maybe switching gears to the Diagnostic portfolio, and maybe, Carl, you could answer this one. On the color on PANTHER, I thought the 200 system placements, that came in really strong, better versus what most have expected. Could you just give some color on when you talk about the 50% new placements, were they -- compared with the placements, what are you seeing on the pull through on the box? And what kind of tests are being run? Is it HPV, is it Trichomonas, is it CT/NG? Maybe some comment on the mix?

[Carl W. Hull:]

Sure, Vijay, I'd be happy to give you a little bit of color. We're very, very pleased with how PANTHER's going so far. We've been on the market for about 1.5 years in Europe, and that's continued to look good for us. From a placement point of view, with the introduction here in the U.S. earlier this year has really accelerated the placement rates of the systems, and our funnel is full. So as we look at future placements, we also feel optimistic based on the performance today. And most importantly, I think Rob touched on this, is the continued extremely positive customer reactions to the system. They're driving placements, and we feel that, that trend is going to continue in the near term. Right now, as you may recall, the focus of our sales efforts is on the APTIMA Combo 2 assay, the first assay that was approved here in the United States. And we expect future assay menu expansion along with incremental revenues as we add Trich and HPV -- to HPV, excuse me, to it over the course of really the next 14 to 16 months. So all in all, we're very happy.

[Operator:]

Moving on to Isaac Ro with Goldman Sachs.

[Isaac Ro:]

Could you guys maybe speak generally on what you're seeing in pricing trends for Diagnostics? And the reason I asked is we're obviously looking at a pretty stagnant volume environment. And as we think about capital spending from a lot of your customers in that market, wondering what you're seeing as pushback both in your new products as well as your mature products?

[Robert A. Cascella:]

And you asked, Isaac, about Diagnostics specifically?

[Isaac Ro:]

Yes.

[Robert A. Cascella:]

Yes, I -- look, the market that seems to be under a lot of pressure relative to pricing is HPV, and that shouldn't be a surprise to anyone. There's a lot of new competition, and we're seeing that on a global basis. We have not seen that relative to our CT/GC franchise. And we believe that obviously there is a decision path that's being made relative to automation workload and the workflow and the quality of our assay, and we have not seen a threat in that business as of yet. So if I were to categorize where we see the greatest decline and it's new business for us, so it's not an erosion, and our AUPs or otherwise is in the HPV market.

[Isaac Ro:]

Fair enough. And then maybe second question, on cost synergies. Glenn, in the past you guys you've done a very good job on delivering there. Could you maybe comment on any incremental opportunities that you've found since the deal closed and maybe give us some color on what the battle plan looks like over the next 3 to 6 months?

[Glenn P. Muir:]

Well, I think we're pretty happy with what we've found. We went into the day 1 with a pretty good thought-out game plan on what we were trying to achieve with the sales force and how we were going to align all the facilities. So we're right on track to where we wanted to be. We talked about the $40 million in year 1, but clearly, we'll do much better than that for this first year in fiscal 2013. And we'll get up to that $75 million in annual synergies as quick as we can.

[Operator:]

Our next question comes from Richard Newitter with Leerink Swann.

[Richard Newitter:]

If I could just maybe start first on tomo on your reimbursement commentary. Can you just describe what the -- what you have to set in motion and what exactly gets pushed back in the timelines for when we see a publication and what happens on the back end?

[Peter K. Soltani:]

Sure, Rich, this is Peter. So really, the trigger for starting the more formal discussions with the appropriate entities is having peer-reviewed publications in hand. And we know at this point, there are 3 key ones that we're looking for. One, we were just notified as an Epub form, that's the diagnostic study by Dr. Rita Zuli [ph] from UPMC, and that's in radiology. The other two, as Rob had mentioned earlier, Dr. Rafferty's paper, which is essentially our FDA study. And of course, the Oslo one. All of them, well, one is in Epub form, the other 2 have been accepted by radiology, and it's just a matter of us waiting. As much as we wish we could move things ahead, we really don't have any control over the editorial processes of the journals, so we just need for these papers to be published and in our hand. At that point, we can go in and have subsequent discussions and get that process moving forward.

[Richard Newitter:]

Okay. And then maybe just on your guidance, if you could -- in the past, you've mentioned your cost synergy assumptions. And you've also emphasized that you're not forecasting significant sales synergies. Is that the case with your current guidance relative to Gen-Probe or can you talk about any expectations that you have from sales synergies that are not included in your current guidance?

[Robert A. Cascella:]

Yes, we're not including substantial revenue synergies for one reason, not because we don't believe in them. We believe they will come to fruition, but all of those take a tremendous amount of time because if you think about it, we're really into a training mode. We're into a strategic mode relative to unit placements and so on and so forth. I mean the PANTHERs that are going in today were growing volume that is CT/GC only, as we get FDA approvals on that system, we're going to broaden the menu and we'll be able to leverage more of our lab salesforce and our physician sales teams to start driving more volume to those. So I think we had said this earlier, we strongly believe that an added benefit is our revenue synergies. We just think that they materialize over a period of time.

[Operator:]

And we'll now hear from Doug Schenkel with Cowen & Company.

[Doug Schenkel:]

As you place more PANTHER instruments and as Chlamydia or Gonorrhea volumes increase on PANTHER, are you seeing anything that would give you an indication of how Chlamydia and Gonorrhea volumes on TIGRIS may be affected? And how is this reflected into your guidance? And then I guess just as a somewhat related follow-up, Carl, any update you can provide and how Trich is impacting the annuity stream on TIGRIS?

[Peter K. Soltani:]

Sure, Doug, I'd be happy to try and address that. I think you're looking at question of whether there might be cannibalization on TIGRIS rather on this -- on either side from the placement of PANTHER. And we certainly don't see that at this point. I think it might be too early to tell, but I would also tell you I don't think that's a realistic possibility. We're really targeting PANTHER at places that we have not been able to place TIGRIS up until now. As a result of that, in many senses, those are incremental revenue. Now we are converting some customers from the older semi-automated systems, so there would be a little of a substitution effect with APTIMA revenues run on our older generation products. But I really don't see that on TIGRIS, and I don't see that either with CT/GC or Trich.

[Doug Schenkel:]

So I guess the important point there is given a lot of these volumes are done today on TIGRIS instruments at large reference labs just because you are now penetrating some of the relatively smaller labs and taking advantage of some of these decentralization trend, you think the market is growing enough where there's not enough material cannibalization nor will there be for the next year or so?

[Carl W. Hull:]

We certainly think that the -- we will outperform the old market growth rates, but I also think it's important to point out that we are taking some of this business away from directly competitive assays. So in that sense, it's growth for us. It may not be growth for the market in those cases.

[Operator:]

David Lewis with Morgan Stanley has the next question.

[David R. Lewis:]

I guess I would say the model is largely in line with our assumptions. A couple of points I wanted to push out, if I could. For the first is just thinking about Diagnostic revenue for fiscal '13. I don't know if you got a specific guidance figure, but it does look like organically that number is a little lower than we were expecting. Could you sort of walk us through the organic growth for Diagnostics or the total growth you're expecting organically more helpful, and any of the pieces that we may be missing heading into fiscal '13?

[Robert A. Cascella:]

Are we talking the first quarter, David, or fiscal 2013 in total?

[David R. Lewis:]

More interested in fiscal '13, because it just appears that all your lines of business, Glenn, came in, in line or better than they're modeled. Diagnostics is the one outlier. I'm just trying to understand if there was a -- what's the organic growth for '13, or is there a dynamic we may be missing, which is important to the Diagnostic growth rate for '13?

[Glenn P. Muir:]

Yes. Well, there are a couple of pieces. I think for the other segments, the other 3, if we look at the full fiscal 2013, we should be in this mid-single-digit kind of growth. So we are kind of carving Diagnostics out a little bit because of the acquisition itself. And there's couple of pieces. There's Gen-Probe products, and there's Hologic products. And we go forward in fiscal 2013, they're all going to be sold by one entity. So it's going to be very difficult to break them out into 2 segments but I can tell you that when we think about the pieces of the products themselves, that we're looking at Gen-Probe products growing in a low-double digit kind of ratio and the Hologic products in a low to mid single, the ThinPrep being on the low single digit side.

[David R. Lewis:]

Okay. And those are operational or quasi-organic numbers, Glenn?

[Glenn P. Muir:]

Yes. Yes, everything would be -- well, yes, quasi-organic rate.

[David R. Lewis:]

Okay, very helpful. And the second thing, Glenn, just to -- numbers are pretty close to your operating expense assumptions that they would have expected. But incrementally, we found that gross margins were a little lower than we were expecting and operating expenses maybe a little bit higher considering your synergies. Were there any reclassifications that are sort of pressuring gross margin heading into fiscal '13?

[Glenn P. Muir:]

No. There were no reclasses, but I think you were right, David, that in the quarter itself, we really did have a tick-up in some service, warranty and manufacturing costs that, at the end of the day, I think we're more aligned to one-time of expenses that had been corrected going forward. So you are correct. The gross margins came in a few basis points less than where we would have expected.

[David R. Lewis:]

Okay, but that should resolve itself throughout the course of '13?

[Glenn P. Muir:]

We believe so, yes. And it wasn't a reclass. It was more a one-time item.

[Operator:]

Moving on to Amit Bhalla with Citi.

[Amit Bhalla:]

I just have a -- just wanted to understand the earnings guidance for '13 for a second. $0.20 of accretion from Gen-Probe would make the base business essentially flat in earnings year-over-year. Glenn, can you just elaborate on that flat to slightly weaker earnings on the base business for next year?

[Glenn P. Muir:]

Yes. Let me try. And this will be kind of high level, maybe kind of back of an envelope if we could. You're kind of alluding to our starting point today of the $1.38 where we ended fiscal 2012. And the pieces, I guess, we have to consider are, number one, the growth rate you have for Hologic on EPS going into FY '13. So I don't know what you had exactly, but I would think we'd be close to some kind of a double-digit growth on EPS.

[Amit Bhalla:]

Well, that combined entity grow in double digits. But take the $0.20 of discrete...

[Glenn P. Muir:]

No, just Hologic legacy, that would be the first piece without Gen-Probe. The second piece would be, as you mentioned, we talked before about when we look at Gen-Probe's contribution in FY '13, we're looking for $0.20 accretion. And that also is a true statement, that is what we're looking for in FY '13. I don't believe we have given full credit for all that expectation in the current EPS guidance for FY '13. I would have to say we've been a little bit more conservative in building all of that in simply because we're at the very beginning of the year, and this is kind of consistent with past practice on how we think about the fiscal year itself. So I would remind you of those 2 pieces. But third, let's not forget that the other piece we have to contend with is a medical device tax as well, which we would not have had before and might not be built into your thought. So there's $0.05 there or $0.06 is what I said on the call.

[Amit Bhalla:]

So you're saying the base Hologic business earnings would grow double digits. The Gen-Probe $0.20 of accretion, you're not fully putting it in there, and device tax is another $0.06. Is that -- did I hear that right?

[Robert A. Cascella:]

Well, I think the most definitive of what I was trying to say is the $0.06. I was hoping to leave you with the thought that we were looking to grow the business on the Hologic legacy towards a double-digit growth, and we certainly think we can get $0.20 out of Gen-Probe. But our guidance, we're not looking to guide anyone to quite that level this early in the year.

[Amit Bhalla:]

Okay. I'll follow up with you offline, but the -- and my second question just had to do with your Breast Health guidance. And I just want to clarify. I think you said in your prepared comments that Breast Health growth would be mid single digits in the first quarter and for the full year, but your slides say low single digits for the first quarter and high single digits for the first year -- for the full year. Can you just clarify what is Breast Health guidance?

[Robert A. Cascella:]

I might have to look at that slide, Amit. I think the mid -- we're talking Q1 or fiscal year?

[Amit Bhalla:]

For both. They're both different in the slides versus what you said.

[Amit Bhalla:]

Well, let me take a look at the slides and maybe we can come back to that after the next question. Give me a second to look at them.

[Operator:]

Tycho Peterson with JPMorgan has the next question.

[Tycho W. Peterson:]

First one, just the contribution of the extra week, I know you quantified that. But you had 8% extra days and only 1% revenue benefit. Why wasn't that more? I mean, 63% of your revenues is consumable, so why wasn't it a higher contribution?

[Robert A. Cascella:]

Yes, I don't think that's -- well, it's a tough one, Tycho, to look at it that way. It just doesn't -- it doesn't work out on a weekly basis. I mean, at the end of the day, you have 13 weeks of selling effort in a 14-week period. I mean, it's just the way salespeople are compensated and the commission plans run. You don’t get the full credit. It's very clear in the capital equipment side that there was no impact. I mean that was crystal clear. But even on the disposable side and with some of the surgical products, we didn't see -- and it's not the last week of the quarter. It's one of the weeks before the end of the quarter. We just didn't see a big increase that we thought was related more than maybe up to $5 million for the quarter. So that is all that we thought it might be. It's a lot different on the expense side because you truly get 14 weeks of expenses and it's 14 weeks of everything. So the expenses had a far greater impact having an extra week than the revenues did.

[Tycho W. Peterson:]

Okay. And then on HPV, I mean given where you are early days in the ramp, you've talked about it being up 20%. Why not -- why isn't that more given where you are in the U.S. launch? Is it just the inherent negotiation times with the labs that, that wouldn't be up more?

[Robert A. Cascella:]

I think that there's a lengthy period of validation, Tycho, that goes on to every one of these new placements. So in some cases, months and months are passing by before we're starting to see revenues. So we're closing accounts. We have a substantial level of competitive takeaways, but we're not seeing -- we won't see the benefit of it immediately. So I think that what we're trying to explain and what we're showing in our guidance is really that lag time and that transition to revenue.

[Operator:]

And we'll now hear from Anthony Petrone with Jefferies.

[Anthony Petrone:]

One quick one for Glenn, a clarification. Can you break out the estimate of EPS impact from Novartis this quarter, and maybe what that is for next quarter next year?

[Glenn P. Muir:]

I'm sorry, EPS?

[Deborah R. Gordon:]

Novartis impact.

[Robert A. Cascella:]

The EPS impact on Novartis.

[Glenn P. Muir:]

The EPS impact on Novartis, are we talking about the reduction in revenues related to purchase accounting adjustment or just...

[Anthony Petrone:]

Yes, exactly. So it seems to be excluded from your guidance next year, the revenue guidance, so I'm wondering how that works down to EPS.

[Glenn P. Muir:]

Well, it also flushes through to EPS because what we did was we capitalized the amount of usage by the customer in billings that normally happen as a true-up during the quarter. We previously capitalized all that since the shipment left the docks of Gen-Probe. So as it would have been recorded in the quarter, the customers use the assays, it's already in purchase accounting and it's been allocated to all the accounts. So that effect in FY '13 is the $22 million for all of fiscal 2013, and we'll provide a non-GAAP adjustment, so revenues at $22 million higher for FY '13.

[Anthony Petrone:]

Right. So that non-GAAP of $1.56 to $1.58 already accounts for that?

[Glenn P. Muir:]

It does.

[Anthony Petrone:]

Okay. And then, Rob, on tomo. Just to go back to your comments earlier, you mentioned you can nearly double the base from where we are at the end of this year. And there's a range that you had out there, 500 to 700. But it sounds like you're effectively increasing that range. And so I'm wondering if I could...

[Robert A. Cascella:]

We -- what we actually said was the 500 to 700 would happen within the 2 years following FDA approval. So we actually come to the conclusion of that period by the half. And so what I'm effectively saying is that for all of fiscal '13, whatever the installed base domestically is will virtually double or nearly double over the course of this year. So we're really saying the 500 to 700 units is an old data point. We feel very confident that by the half, we will have met that number, and what I -- what we're trying to do by telling you that whatever the installed base of domestic units were as of the end '12 will nearly double over the course of '13.

[Anthony Petrone:]

That's helpful. And then last one real quick for me, for Carl. The split for the 200 Panther installed base, I don’t know if you can give that. U.S., OUS, I believe at the time of the acquisition, it was $80 million OUS, and maybe perhaps your view on the average annuity stream for both of these systems.

[Carl W. Hull:]

Well, I think, Anthony, we're probably not going to get into that degree of granularity on a go-forward basis with the instrument to forecast. We are trying to give you a good starting point in saying that we're north of 200 as it is right now, and I think I'll just leave it at that. Our expectations in terms of the average reagent trails for PANTHER have always been the ramp as we introduce new menu to the system. And I don't think we have been particularly able to give you a good number yet. I'd say after about 2, 3 quarters of placement experience under our belt, people up to speed and run and test the record, we'll have a better handle on that. But we're not seeing anything in the current trends that are different than our initial assumptions.

[Anthony Petrone:]

Great. And just the split on the 200?

[Carl W. Hull:]

I don't think we're going to go OUS domestic on that on a go-forward basis.

[Operator:]

Bill Quirk with Piper Jaffray has the next question.

[William R. Quirk:]

So first off, Glenn, thinking about the commentary around your $50 million [ph] first year going to $75 million over about 3. Based on diligence, it looks like you guys are starting the plant consolidation phase and as well as consolidating from a salesforce standpoint. And so correct me if I'm wrong here, but this all seems to lead up to $40 million being a awfully conservative number here for fiscal '13?

[Glenn P. Muir:]

I would agree with that statement.

[Robert A. Cascella:]

Yes, I think in fairness, I think what we want, at least we view it, is a lot of the synergies that are coming out of the businesses have to do with plant closures. Those are now happening this year. So you're right, there is salesforce consolidation, there's engineering consolidation. But a substantial amount of what we're deriving from synergies has come from exiting the Madison facility, and that's 18 months to 24 months away.

[William R. Quirk:]

Okay, got it, I appreciate the clarification there. And then my follow-up question for Carl. Carl, can you talk a little bit about if we think about the initial synergies from combining the 2 sales teams, if we first think about Chlamydia/Gonorrhea, fold Trich in, say, the back half of '13 or is it something that you think the team can deliver both roughly around the same time?

[Carl W. Hull:]

Sure, Bill, I'd be happy to. I think that you're right in terms of the order, you'll see CT/GC first and then it'll be followed by Trich. I would say that before we see substantial upside and then top-line growth here in the United States, you're probably looking out another 6 months, I'd say. And then for the back half of the fiscal year, I think you'll begin to see the impact of CT/GC, and that's because obviously it's an established assay, the guidelines are there. And it's the first product the sales -- the combined salesforces will be detailing universally. Trich is right behind that. But I think Trich in some cases, as you know, it's still early in its development market phase. And so there's a little bit more education that has to happen, and I would think that, that would follow again probably over 3 to 6 months period of time after you see the CT/GC.

[Operator:]

We'll hear from Lennox Ketner with Bank of America.

[Lennox Ketner:]

I guess, I just wanted to go back to the revenue guidance because I'm just struggling -- and this may have to do with the conflicting numbers on Breast Health. But if my math is right, your overall revenue guidance implies only about 3% to 4% pro forma growth, just making some assumptions on the Gen-Probe side. And yet, every component of your revenue guidance is mid single digits or higher. Even if you assume Breast Health is really supposed to be low single digits, every other component is mid single digits, somewhere between mid single digits and double-digit growth. So I'm just wondering how you got to the 3% or 4% revenue growth overall?

[Glenn P. Muir:]

Okay. Well, the 3% to 4% does sound a little low, Lennox . Let me go back to the Breast Health guidance if I can, and maybe we can try to reconcile that. I know Amit asked the question on Breast Health guidance because in my remarks I did talk about the first quarter of '13 and I talked about fiscal 2013, and that Breast Health in both periods would grow in the mid single digits. Now I was talking year-over-year. So I was talking Q1 '13 over Q1 '12, and I was talking fiscal '13 over fiscal '12. If you go to the presentation we have on our website, we have to be a little bit careful because the Q1 comparison is a sequential comparison with Q4 of '12. So in that presentation, we talked about Breast Health growing in the low single digits. And it's close to flat because Q4 is always a strong Breast Health quarter for us. In Q1, we go into the RSNA period, and there's little -- always a little bit of softness in Breast Health. So that does sync up. When we think about fiscal 2013 over fiscal 2012, in the presentation itself, we do have in here Breast Health for the high single digits. And in fact, that is where we are. We're between what I said a mid single and high single. Both numbers are, in fact, correct. I know it sounds high, but we're right in that range for Breast Health for FY '13, that mid to high single digit. That's on the Breast Health, Lennox. I know -- I'm not sure that helps you on the overall 3% to 4%, but -- did that help?

[Lennox Ketner:]

Okay. But you think the 3% to 4% pro forma growth is too low? I mean I'm basically just making some assumption what the overall Gen-Probe revenues would have been this quarter, and adding in your 2012 numbers, it's -- I'm coming up 3% to 4% pro forma growth.

[Glenn P. Muir:]

Yes, well, I'd want to know what your pro forma number is. It's hard for me to say without -- I mean we used to talk about your pro forma to make sure. If you're not coming out to the guidance that we gave, something's wrong.

[Lennox Ketner:]

Okay. We can solve it offline. And then last question is just obviously MyoSure has been a good source of growth to you guys last few quarters. I'm just wondering if there's any update on the litigation with Smith & Nephew there and kind of what the next steps are?

[Robert A. Cascella:]

It's very early on. And normally, we don't share the details, Lennox. I think we have ways to go. We're certainly optimistic about our positioning on this, and we haven't really even begun the appeals process.

[Operator:]

We have time for one additional question, which will come from Jason Mills with Canaccord Genuity.

[Jason R. Mills:]

Glenn, first question. Going back to Dave Lewis' question on gross margin, just trying to get a sense of your guidance rather to sort of the combination of the 2 businesses would suggest gross margin sort of pro forma basis would be 100 basis points higher or so relative to what guidance you did give. So just curious, your thoughts on why the gross margin guidance isn't a bit higher.

[Glenn P. Muir:]

Yes, I think when we did a few positives, I mean look at fiscal 2013, and those positives are that the Gen-Probe gross margins in general are higher than our corporate average. They're not as high as some of our Surgical products or ThinPrep, but they are in fact higher than our corporate average itself. But you're correct that revenue introduction is going to help positively on those gross margins. In addition to that, we are talking about overall growth in all of our segments, which is going to help drive the gross margins up as well. So when we look at FY '13, what I would say's is FY '13 is higher than FY '12. And it's about 100 basis points higher. So your question is could it even be 100 basis points higher than that? And I think there is some room there. I mean, once again, this is early on for the fiscal year. It's early on in our guidance. And we would like to see how the year plays out and what the mix is between our domestic and international because there's a big focus for us right now on international, and we all know the international gross margins are a little bit lower than the domestic. So since it's early in the year, this is the range that we're most comfortable with to start off.

[Jason R. Mills:]

Okay, that's very helpful. And, Rob, on the Breast Health side, just wondering, your thoughts on -- clearly your guidance seemingly reflects some appreciation for the capital equipment market, the global economic situation that you find yourself in, as well as the reimbursement timing. Just wanted to get a sense for if those things were more on the positive side, then they are. And clearly from a global economic perspective, it's a fluid situation. But if we were sitting here talking about a more optimistic purview in terms of the global economic situation as well as reimbursement sort of being along the lines of your original expectations, just wondering if you would humor us with your thoughts on what your guidance may have been with those 2 things on a more positive light? Just given the underlying trends in the business we're positive in the quarter.

[Glenn P. Muir:]

Yes. Look, clearly the situation in Europe is not improving, and that's a major market for tomosynthesis. There's a lot of uncertainty here in the states, and reimbursement being a major factor in all of that relative to the economic decision-making process. My point earlier about it is it did not impact our guidance, but I still believe the product is at a very early stage in its adoption. So sure, would we -- if all of the things magically changed tomorrow and the economic situation cured itself and we have reimbursement, would we have an uptick in the number of units that we're comfortable with quoting? Yes. What that number is, unfortunately, I -- off the top of my head, I wouldn't want to venture a guess. But yes, there would be some positive movement as a result of that.

[Jason R. Mills:]

Sure, I understand. I guess where we said we have to model up beyond the year in which you give a guidance, so as we think about sort of the fiscal '14 time period, those comments are helpful.

[Glenn P. Muir:]

I -- look, I think we said that this tomo installed base or the installed base of digital mammography is going to turn over a 3 to 5-year period, and we see nothing that derails the adoption of tomo for the long term. There's always going to be these obstacles and kind of bends in the road, but we think for the long term that digital mammography is replaced by 3D mammography, and it will be a matter of years in terms of the growth cycle of that product.

[Operator:]

And again, ladies and gentlemen, that does conclude our conference -- or our Q&A session for today. I'll turn the conference back to the speakers for additional or closing remarks.

[Robert A. Cascella:]

Nothing from our end. We really appreciate everyone participating in the call, and we look forward to seeing everyone at RSNA this year. Thank you.

[Operator:]

And again, ladies and gentlemen, that does conclude our conference for today. We thank you all for your participation.