Hologic, Inc.
Q4 2013 Earnings Call Transcript

Published: 12 Nov 2013

[Operator:]

Ladies and gentlemen, good afternoon, and welcome to the Hologic Inc. Fourth Quarter Fiscal 2013 Earnings Conference Call. My name is Joyce, and I am your operator for today's call. Today's conference call is being recorded. [Operator Instructions] And I would now like to introduce Deborah Gordon, Vice President, Investor Relations, to begin the call.

[Deborah R. Gordon:]

Thank you, and good afternoon and thank you for joining us for Hologic's Fourth Quarter Fiscal 2013 Earnings Call. The replay of this call will be archived on our website through Friday, November 29; and a copy of our press release discussing our fourth quarter results, as well as our first quarter and fiscal 2014 guidance, is available on the Overview section of the Investor Relations section of our 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 actual results to be materially different from any future results implied by such statements. Such factors include those referenced in our Safe Harbor statement and our fourth quarter 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. [Operator Instructions] With that, I'd now like to turn the call over to Jack Cumming, President and Chief Executive Officer.

[John W. Cumming:]

Thank you, Deb, and thank you, all, for joining us on this Veterans Day today, where we're all thankful and appreciative of the men and women who have served our country over these many years to defend our freedom. Today, I will first review our fourth quarter highlights then update you on the headway we have made on the initiatives we outlined in our last call. Next, I will share our key operating priorities for 2014 and the dynamics driving our business in this fiscal year and beyond. I will then turn the call over to Glenn for a detailed financial discussion. Fiscal '13 was a year of significant change at Hologic. While there were many positives to report, we had to confront challenges in some of our businesses and, therefore, have taken the necessary steps to align our resources and position ourselves for the future. Organizational change doesn't happen overnight and fiscal '14 will be a year of transition for the company. The good news is our core products are the technological and market share leaders in their respective segments, which will help us power through a number of secular headwinds in FY '14. It is our objective to leverage our core franchises to drive organic growth and position us for the future. I'm excited about our prospects, as revenue growth will return in FY '15 and continue on an upward trend. To set the stage for where we stand today, let's take a look at some of the operational highlights for the fourth quarter. In our Diagnostics group, we continued to make strides in our molecular franchise. During the quarter, we made substantial progress laying the groundwork to capitalize on our agreement with Quest. To date, we have installed almost all the instrumentation required to support conversion through our women's health assays. Our agreement with Quest represents an important example of the strategic fit of Gen-Probe with our legacy cytology business. In addition to Quest's new business, we added a significant number of new medium and high-volume molecular customers in the U.S. Aptima HPV has been an important driver of new account wins and this trend should continue, following our recent FDA approvals for use on Panther, including last week's announcement of approval of the Aptima HPV 16 18/45 genotype assay. Based on the strength of our molecular franchise, we are confident about our prospects for additional large laboratory business, which, we believe, will be a mix of new contract wins and growth in existing accounts. Our Panther launch continues to roll out successfully and, in Q4, was a driver of new customer wins, reflecting our focus on account conversions. For the fiscal year, we more than tripled our installed base of Panthers in the U.S., with our most prolific quarters coming in Q3 and Q4. We now have placed almost 500 Panthers globally and remain on track to achieve our stated goal of installing 1,000 Panthers by the end of 2015. I'm pleased with our increase in the system placements in FY '13. Our strategy of locking up sockets will not only contribute incremental revenues in '14 but also set the stage for even greater volumes in the long term, as we continue to expand our menu of tests and share of laboratory real estate with our space-saving Panther footprint. Before moving on to Breast Health, I'd like to comment on the announcement earlier today of Grifols' acquisition of the Novartis diagnostic business and how it relates to our blood screening business. We have been aware of the pending transaction and have had productive conversations with Novartis and Grifols. We have a longstanding direct relationship with Grifols, who has been a respected customer as part of our collaboration with Novartis. We believe Grifols' acquisition has a strong strategic rationale and will make it a powerful and focused player in the blood products and blood safety market. We're confident Grifols will continue the successful commercial execution of our products, as well as provide new opportunities for growth based on their industry experience. This business represents 20% of Grifols' total sales and therefore, we believe their focus and resources on growing this business will improve the long-term prospects. Turning to our Breast Health group. 3D tomosynthesis continues to gain ground. We were able to build on the third quarter results and grow the business on both a sequential and a year-over-year basis. In fact, we placed a record number of 3D systems worldwide and in the U.S. and posted our highest tomo bookings quarter ever. Clearly, we are seeing the positive impact of recent peer-reviewed publications, which are helping to build both awareness and demand for the technology. We ended the year with the domestic installed base of just over 750 systems, more than achieving our stated goal of doubling our installed base during the fiscal year. As you know, our success to date has been accomplished despite the absence of a formal reimbursement code. Notwithstanding this, we're focused on securing a code and concurrently are working to secure reimbursement from private payors. We continue to have success obtaining private payor coverage in our highly engaged and encouraging dialogue numerous commercial health plans, and we will look forward to reporting further progress on this in the quarters ahead. In our Surgical segment, MyoSure remains a strong performer with high double-digit growth over last fiscal year and ample opportunity to maintain an attractive growth trajectory. Moving forward, I will now review the progress we have made on the key strategic initiatives outlined during our last quarterly call. On August 5, I highlighted 4 initiatives that would represent my initial focus as President and CEO

[Glenn P. Muir:]

Thank you, Jack. I will begin by reviewing our fourth quarter financial results, including key segments, balance sheet and cash flow details. I will then provide an update on the plan we have developed to deleverage the balance sheet and the return of cash to shareholders, as well as the executive compensation plan recently approved by our board. Lastly, I will discuss our first quarter and full fiscal year 2014 financial guidance. Unless otherwise noted, all of my commentary on changes will be on a year-over-year basis. Fourth quarter revenues totaled $622 million, an increase of 5.7% compared to reported revenues of $588 million and 3.7% compared to non-GAAP revenues of $600 million, which reflect the addition of an $11.6 million purchase accounting adjustment recorded in the prior year. On a pro forma basis, revenues declined 2%, representing a full quarter of Gen-Probe in the prior year and adjusted to exclude divested businesses, such as Lifecodes. While we experienced significant increases in sales of our 3D tomo and MyoSure product lines, as well as a nice increase in service revenues, these increases were offset by lower ThinPrep and NovaSure sales and, as expected, fewer 2D mammography system sales due to the mix shift to 3D. Foreign currencies had a negligible impact on revenues. I will now review revenues result by segment, beginning with our largest segment. Diagnostics increased over 14% to $290 million on a reported basis and over 9% on a non-GAAP basis. This increase was due to the addition of Gen-Probe for a full quarter; on a pro forma basis, representing a full quarter of Gen-Probe and excluding divested businesses in the prior year, Diagnostics declined 2.6%. This is driven primarily by the combination of an 11% increase in legacy Gen-Probe sales, offset by a 13% decline in legacy Diagnostics. I would like to note that starting in the first quarter, we will be speaking to Diagnostic revenues and growth rates on an organic basis, and will no longer refer to legacy Diagnostics and Gen-Probe separately, as we have passed this anniversary and fully integrated the acquisition. Within our legacy Diagnostics business, worldwide ThinPrep volumes were flat year-over-year. However, ThinPrep revenues declined over 13%, driven by continued volume pressure domestically due to extended intervals and lower international pricing. Gen-Probe revenues of $148 million increased 65% and 46% on a reported and a non-GAAP basis, respectively. On a pro forma basis, revenues increased almost 11%. In an effort to best reflect the ongoing profile of the Gen-Probe business, the following discussion is on a pro forma basis. Clinical Diagnostics revenues within Gen-Probe, which are primarily comprised of our Aptima family of assays for CT/GC HPV and Trich, grew almost 17%. The largest contributor to this increase was from the significant number of instrument sales to Quest as part of our new agreement. To date, we have installed almost all of the instrumentation that will be required to support conversion to our women's health assays. While these equipment sales had below average Diagnostics margins, they demonstrate Quest's commitment to our leading technologies and lay the groundwork for substantial downstream assay revenues. Capturing these incremental volumes will be an important element of our growth in molecular diagnostics during fiscal 2014 and beyond. Panther assay revenues continued ramping up nicely and we look forward to a continuation of this trend, as the launch of HPV on Panther is still relatively early. We have now installed almost 500 Panthers worldwide. Also, blood screening revenues were up 1%. Overall, we remain pleased with the integration and performance of Gen-Probe, though the pace of incremental revenue growth is slower than our initial projections at the time of the acquisition. We remain excited about the long-term outlook for this business, especially as the Panther rollout progresses, as we further expand our test menu. Breast Health increased to $234 million or approximately 2%. Primarily driving this increase was service revenue growth of 4.3%. Product sales were up slightly with strong global adoption of 3D tomo, largely offset fewer 2D digital system sales as expected. Our Dimensions product line, which includes both our 2D and our 3D systems, represented 82% of worldwide digital mammography product revenues and 72% of units sold this quarter. Overall growth in 3D tomo revenues for Q4 '13 versus the same period last year was just over 50% and grew almost 9% sequentially off the strong tomo sales in Q3. Due to the continued shift to tomo, overall 2D sales were down high teens and 5% sequentially. The increase in 3D sales outpaced the decline in 2D sales for the second quarter in a row. With a significant and growing body of peer-reviewed publications and increase in coverage from private payers, the growth prospects for tomo are robust. As evidence of this, our revenue backlog for all tomo systems is up 15% sequentially. Our 3D domestic installed base was just over 750 units at yearend. Going forward, we intend to provide our 3D installed base annually with qualitative commentary on the rollout during the year. During fiscal 2014, we expect to ship over 500 3D Dimension systems in the U.S. As a reminder, there are 13,000 MQSA mammography systems in the U.S., of which 12,000 are digital, some dating back to 2002; and of which, 60% are Hologic. Overall, we are very pleased with our progress in commercializing tomo and we continue to have high expectations for this best-in-class technology. We remain confident tomo will become the standard of care. Now turning to GYN Surgical. Revenues were $77 million, declining approximately 4%. MyoSure continued its strong growth with almost 6% [ph] increase in revenues. This product is still in the early stages of its commercial cycle and we believe with our planned product expansions and the opportunities for geographic expansion, MyoSure is in a position to help drive growth in GYN Surgical in the future. NovaSure continues to pressure segment results, driven by a combination of lower-cost treatment options and lower utilization. We remain focused on programs designed to mitigate these effects domestically, as well as on international expansion. In fact, NovaSure experienced a record quarter outside the U.S. in the fourth quarter. I will now review fourth quarter non-GAAP performance for the rest of the P&L. Gross margins of 61.5% were down 70 basis points year-over-year and 90 basis points sequentially. This was below our guidance range of 62% to 62.5%, driven primarily by the initial equipment orders from Quest being filled sooner than anticipated, as Quest's interested [ph] in accelerating equipment placements in order to begin using our assays. There was also a greater-than-expected mix shift away from higher-margin products such as ThinPrep. Operating expenses of $175 million declined almost $12 million or 6% and represented 28% of sales. Sequentially, operating expenses were down 5% and at the low end of the guidance range we provided last quarter. Operating expenses this quarter included $3.8 million for the medical device Tax. In fiscal 2013, 1 year post the Gen-Probe acquisition, we achieved $70 million in cost synergies, above our initial target of $40 million dollars. We have now realized just about all of the expected 3-year $75 million-plus synergies and are squarely focused on driving revenue synergies from the combination. As a result of quarterly revenue result at the high end of our guidance range, coupled with our strong expense management and reduced interest expense, net income was $108 million with EPS of $0.39, which was above our guidance range of $0.36 to $0.37. Before moving to the balance sheet, I would like to discuss the fourth quarter impairment charge we announced in today's earnings release. As you know, we have a large goodwill balance resulting from acquisitions. Accounting rules require an annual review for impairment. In the fourth quarter, we completed this analysis and based on the combination of factors, including a full reevaluation of the company's existing product development efforts and cost structure, as well as a change in revenue forecast, we determined a portion of goodwill was impaired. The impairment was within molecular diagnostics, both legacy Gen-Probe and legacy Hologic Third Wave. As a result, we recorded a noncash goodwill write-down of $1.1 billion. Importantly, while the tempered growth outlook reduced our current valuation of these assets on an accounting basis, we remain extremely encouraged by the long-term growth opportunities that molecular business provides. We do not expect this charge to result in any future cash expenditures or otherwise affect the ongoing business or financial performance of this very important business segment. Now turning to our balance sheet and other key financial metrics. We finished the fiscal year with cash of $829 million, up $263 million year-over-year and down $135 million sequentially. The lower sequential cash balance was expected as a result of various plan payments during the quarter, such as debt paydown of $216 million, contingent earnouts of $9 million [ph] , taxes of $43 million and interest of $39 million. We are very fortunate to have a strong cash flow profile, allowing us to generate over $600 million in operating cash flow during fiscal 2013, in line with the guidance we provided. In prior quarters, we have reported operating cash flow before taking into account the interest on new debt to finance Gen-Probe to illustrate the pre-financing cash-generation profile of the combination. For fiscal 2013, this operating cash flow measurement was $690 million. Going forward, I will focus on the net operating cash flow of the combined entity, including the interest cost. For fiscal 2013, it was $630 million. Both of these measurements and their calculations can be found in our PowerPoint presentation available on the Investor Relations page of our website. Throughout the fiscal year, we took measures to improve our balance sheet where possible. Toward that end, in August, we announced the repricing of our Term Loan B, made a $200 million voluntary prepayment on this debt and amended the restrictive covenants in our credit agreement to increase our capacity for our share repurchase or dividend. We ended the fiscal year with total debt obligations of $4.9 billion and our net debt-to-EBITDA ratio stands at 4.6x. Now I'd like to provide some detail on some of the initiatives that Jack discussed with regard to capital allocation. As we have stated before, our #1 priority is to continue deleveraging the company. Over the next 4 years, we will have $1.9 billion in mandatory debt payments, beginning with the $405 million we will pay next month to retire our outstanding 2007 convertible notes. We believe the $1.9 billion mandatory debt payments will get us to our target net debt-to-EBITDA ratio of 2.5x by the end of fiscal 2017. I appreciate this timeframe is further out than our initial target of fiscal 2015. However, we have moderated our forecast, which we now believe reflects a more realistic growth profile. During this 4-year period, we expect to generate approximately $400 million in excess cash flow beyond mandatory debt payments. We intend to do 2 things with this excess cash over this period

[John W. Cumming:]

Thank you very much, Glenn. Since I rejoined the company as CEO, we have taken steps to position ourselves for long-term success. While we still have significant work ahead of us, we are fortunate to be a leader in our key markets and have a team of highly committed associates. Our goals and priorities are clear, and we intend to execute against these goals and position the business to return to growth in 2015. I do appreciate all of you joining us today and we look forward to updating you on our progress. Now I will turn it over to questions, and I should say that David Harding and Rohan Hastie, who run our 2 major businesses, are with us today; and they will be on the call to answer the questions. Operator?

[Operator:]

And our first question comes from Bill Bonello with Craig-Hallum.

[William B. Bonello:]

Just a follow-up on the ThinPrep business, can you give us a sense of sort of where you think you are in terms of the conversion to longer intervals, if that's a process that you expect to be complete by the end of fiscal or calendar '14? And then as part of that, maybe your thoughts on Roche applying for HPV as a primary screen; and if that's approved, what that might mean for ThinPrep trends beyond 2014.

[Rohan F. Hastie:]

This is Roe. Yes, sure, happy to answer those 2 questions. So in terms of the interval expansion, I think we're still expecting to see a double-digit interval expansion within the U.S. for 2014. Again, I think we're still looking for some good share shift away from our competitors that we've seen this year with that regard as well. So I think our market share will increase in that time. The volumes will decrease within that double-digit-plus range for 2014. I certainly think by the time that 2015 comes around, we will start to see a dropping off of that decline, if you would, a much more stabilization within that market. Do I think it will be flat in 2015? Probably not, but it think we will have taken the majority of the falls in 2013 and 2014. And I'm sorry, the second part of the question was?

[William B. Bonello:]

Just your thoughts on Roche applying for an indication to have HPV as a primary screen and what that might mean for ThinPrep longer term.

[Rohan F. Hastie:]

Yes. I think HPV primary will be not as prevalent [ph] within the market primarily. I think that the path is so ingrained within the gynecologist cervical cancer screening modality that migrating away from that to going to an HPV primary is something that, I think, we will be able to manage effectively within the market. We certainly feel that having a large physician sales force can certainly message the benefits of co-testing. I would remind everybody that testing with HPV and a path liquid-based cytology is the best clinical screening modality for cervical cancer, and we will continue to push that message within the marketplace.

[Operator:]

And our next question comes from Shaun Rodriguez with Cowen and Company.

[Shaun Rodriguez:]

So last quarter, I think you mentioned that the Quest deal should result in a meaningful contribution for chlamydia and gonorrhea starting this fourth quarter with HPV may be taking a little longer. So you mentioned they've installed the systems but can you update us on the timing of the utilization ramp here, your assumptions for how this progresses over the course of 2014 and, if you could, the impact this deal will have on your pricing for the overall Gen-Probe business?

[Rohan F. Hastie:]

Yes. So this -- I'll start with the latter part of the question first. There's no doubt that in terms of an AUP within this market, that Quest got some good pricing from what they had previously, based primarily upon the competitive dynamics of this marketplace right now. There are more people selling chlamydia and gonorrhea tests, in terms of the utilization Quest have started right now, switching over to our chlamydia and gonorrhea tests. So we will certainly start to see the pickup of that at the latter end of this quarter and Q2. Their HPV business will take a little longer to convert over so that contribution will take a little bit longer. But I would say that, that is slightly offset by some of the AUP dynamics we're seeing within this market from competitive activity anyway. So we're comfortable with the revenue growth that we're going to get from Panther. We're comfortable with the revenue growth we will get from Quest. So the deals that are being completed right now as, I think, our peer group companies have stated as well, are at slightly lower AUPs than what we've seen previously.

[Operator:]

And our next question comes from Vijay Kumar with ISI Group.

[Vijay Kumar:]

So just on the guidance and, Glenn, I know that you mentioned sort of -- that you would be looking at asset sales. So a, does the guidance contemplate any divestitures? And I guess, if you look at the guidance commentary within the slide deck, you have OpEx up next fiscal year and I believe that's based off of an increase in variable comp. I'm just trying to reconcile, if revenue and EPS is down, how should we think of variable compensation now being up for next year?

[Glenn P. Muir:]

Yes. Vijay, so as it relates to guidance, we don't have any divestitures built in to that guidance today nor do we have any share buybacks or anything like that. So it's our current platform and programs that we have today. If we look at that operating expense line, we do have that flat to up slightly in FY '14 in our guidance. And we have had quite a bit of cost savings throughout the end of FY '13, but one of the areas that we have really skinnied down is the whole area of variable compensation. So when we look at FY '14, and we're not talking at executive level here, we are talking at the real management and rank-and-file level, we are reintroducing some of the variable compensation we didn't have in '13. So that's a piece of the increase that we see; and even with that increase, we're only talking operating expenses up slightly in FY '14.

[Operator:]

And our next question comes from Isaac Ro with Goldman Sachs.

[Isaac Ro:]

You mentioned low single-digit growth in 2015 plus, Glenn, in your prepared comments. Is that the type of growth you expect to see in the business, assuming no changes to the current portfolio? And if so, what kind of health care utilization environment you think you need to have as a backdrop in order to hit that growth?

[Glenn P. Muir:]

Right. So in the prepared guidance, we're talking about low to mid-single-digit growth back in FY '15 on both the top and bottom line. So we are looking at FY '14 as a transformational type of year. We are retrenching a big part of this is because of the market environment we see out there. So when we look out to FY '15, there is an expectation that things are going to stabilize throughout all of FY '14, and we will begin to see growth with some of these new products emerging. So we've been talking about 3D tomo for some time. I talked a little bit about the numbers on systems that we're currently placing. We're getting tremendous interest in that product line. When we look in the Diagnostics group, the Panther machines are just now going out the door. And even for Quest, they didn't have any meaningful sales in Q4, but they certainly will in FY '14. So I think we're getting in place the pieces that we need for that FY '15 growth. But I think the problem we have in '14 is more the headwinds. It really is, as is relates to ThinPrep, the expansion on the interval; as it relates to NovaSure, it's that whole utilization as there are some lower-cost alternatives. And that will moderate. We do believe that will moderate in '15 and beyond. I don't know, Jack, or -- did you have anything to add on that or...

[John W. Cumming:]

No, no, no. No, I'm with you on that.

[Operator:]

And our next question comes from Tycho Peterson with JPMorgan.

[Tycho W. Peterson:]

A couple of follow-ups actually to the prior question, just first on divestitures. You brought up the challenges. You fairly described, I guess, is secular [ph] . But as we think about your options with divestitures, would you be willing to divest declining businesses if it's dilutive to earnings? And then as a follow-up, on sales and marketing, you highlighted some of the cost falls [ph] . Can you give us a sense as to where those occurred? It was a little bit better from a sales and marketing perspective than what we are modeling in terms of cost cuts.

[John W. Cumming:]

Yes. I think that -- Glenn and I will probably both handle that. I think for your first question relative a nonperforming asset, would we sell it, you said, if it was dilutive and the answer is yes. Glenn, on the other one?

[Glenn P. Muir:]

I was focused on the first one, too. I think -- and yes, Tycho, the thing is on most of our operating segments, any one of them would be dilutive to earnings. I mean we have great earnings power in each of those segments now, so we appreciate that. What we have to look at is the value and the potential we would get out and how we would redeploy that cash. So we're looking very hard at that right now. Nothing's off the table, but it is a pretty complex thought process to go through on cash flow and taxes, and we want to get it right. And the second part of the question, Jack, was...

[John W. Cumming:]

Tycho, please repeat it again.

[Tycho W. Peterson:]

Your sales and marketing costs came in lower than we were modeling, and as you highlighted, kind of at the lower end of guidance, maybe just talk to some of the steps you've taken in terms of sales and marketing costs.

[John W. Cumming:]

Well, I'm going to pass it over to, I think, David and Roe, because we have streamlined and we've kind of realigned the forces. So David, you want to go first?

[David P. Harding:]

Yes. We -- this is David Harding. We have definitely taken a hard look at all of our sales and marketing expenses, reflective of the more modest revenue growth rates and have restructured a number of things both on the Surgical and Breast Health side of the business. We've taken out layers of management. We've gotten more efficient in the way that we deploy our marketing expenditures and generally are trying to do more with less at this stage.

[Rohan F. Hastie:]

Yes. And I would echo that, Tycho, seeing the same on the Diagnostic side of the business. We definitely pushed out some of our commercialization efforts. We've just paid very close attention to conference attendance, conference spending, just general marketing spend and likewise, in terms of the overall sales. We're making sure that we are appropriately sized for reach and touch to get the maximum benefit from that sales force. So it's been a management issue just making sure that we keep a close eye on those costs and utilize that cash as effectively as possible.

[Operator:]

And our next question comes from David Lewis of Morgan Stanley.

[James Francescone:]

This is actually James in for David. First, Jack, a question about your role in the business. What can you tell us about your commitment to stay with the business for, not only the upcoming transition year, but also for 2 to 3 years beyond that?

[John W. Cumming:]

Well, since David's not there, I should ask you about his. But I had a feeling that you would ask that since that's one of his favorite ones. Look, until someone tells me differently, I am the permanent CEO here; and I want to make it clear. I'm committed to rebuilding, refocusing the company, address the concerns of all the shareholders, the team members and our customers, who I'm visiting with on a weekly basis. So I think everything I've discussed reflects that level of personal commitment and my focus for delivering those results. So the board has asked me to concentrate on restructuring our business and achieving the strategic and operational goals, which we're committing to today. So I don't know how I can make it any clearer.

[Operator:]

Our next question comes from Michael Matson with Needham & Company.

[Michael Matson:]

I guess I just wanted to ask about, in the mammography market, I guess GE got their CE mark for their tomosynthesis product; and I guess, they're selling in Europe now. So I was wondering if you've seen that in the market, if it's had an impact on your sales outside the U.S.? And then additionally, just what are your thoughts on, when and if that product comes to market in the U.S., does that -- have you accounted for that in your guidance?

[David P. Harding:]

Yes, this is David. I'm happy to take that question. We have seen the unit in the market in Europe, and there are few installations around. We are anticipating that GE will launch in the United States at some point. We are not exactly sure when, but we do anticipate it being within this fiscal year, probably sooner rather than later. We have certainly accounted for that in our projected growth rates, but we are very confident that our product is clinically superior. We've got excellent clinical results proven through large numbers of studies of many, many patients; and we are very, very happy with the way that our system is performing. Again, we will -- we welcome competition in this market and have fully anticipated it.

[John W. Cumming:]

Yes. I would add to that, that this is fully baked into our numbers. We expect GE -- you always expect at RSNA, they're going to announce some approval, so we've anticipated sooner than later. But if you just look at the market itself being a replacement market and the fact that we have 60%, 65% of the U.S. market, GE's strategy is not just go out and say, "Let's see how many of the Hologic and Siemens sites we can go sell our product to." They're going to go to their installed base, which is sizable, and they're going to -- because I would assume that they have a demand -- pent-up demand from not being on the market, so they're going to attack those first. Internationally, they've been out there a very long time with this new product, so it's nothing new to us. I think it's a positive inasmuch as -- I think it might reset some of their pricing because until they've had it, they've priced their 2D system extremely low and maybe this will bring a sense of reality on pricing. Also, I believe in the U.S., it only can help us with them talking about the benefits of tomosynthesis and putting their marketing dollars behind it; and I welcome their marketing dollars, talking about the technology in and by itself. The fact that, like David said, we have over 100 papers written on tomo in almost every major company. We are working with the societies on tomo studies. So we are so well positioned to continue to drive share gains over the next 5 years with this product and subsequent products that we're going to bring to market.

[Operator:]

And our next question comes from Brian Weinstein with William Blair.

[Brian Weinstein:]

My question is on Gen-Probe and the revenue synergies there. You've talked about maximizing those and the pace being slower than you expected. So can you talk specifically, how do you fix that specific steps you're talking about there? And the secondly, on the write-down of the asset, I understand on the molecular side, some Third Wave stuff potentially, but you guys are very positive on the rest of the molecular diagnostics business. So can you talk about specifically what changed relative to your original expectations, given how positive you are, sounding like on the future of that business?

[John W. Cumming:]

When you are talking about the pace slowing down, you meant maybe the uptake. I would assume you meant the uptake in the assays, which certainly has been a factor, especially that we have now installed the system in Quest; and as Roe has talked about, it could be a 6-, 9-month process just to get HPC-certified in these labs. But between Roe and Glenn, I think they can talk about the write-down and the impact on that.

[Rohan F. Hastie:]

Yes, I think we're relatively comfortable with where the revenue synergies are, quite frankly. Again, I think that, as we've stated time and time again, this Quest deal would never have happened had Hologic and Gen-Probe not been combined. And I think we're seeing that portfolio component, that portfolio sale being replicated at all segments of the market right now. We're going again [ph] , and we're talking about ThinPrep, CT/GC, Trichomonas, HPV and that whole portfolio, women's health testing is really starting to have traction within the marketplace. And that, indeed, is being replicated internationally. We've had a couple of very big closes within the United Kingdom over the past 6 months, really, that again, have been portfolio of women's health products that we're offering. So in that regard, the revenue synergies, I think, we are comfortable with. And likewise and then again, with that physician sales force component has been tremendously important for us in terms of generating awareness of Aptima HPV, generating awareness of nucleic acid testing for Trichomonas right now. I think that has made a big, big contribution to us. I think what has happened, though, is some of the AUP pressures that we've seen again from the competitive activity within the market right now for our competitors trying to hold onto business or compete for business has certainly driven down some of the AUPs that we've been seeing. And then also, we had a little bit of a slow start to FY '13 as well, which did not contribute.

[John W. Cumming:]

Yes. I would add one more thing, and that is as far as the synergies go, we exceeded what we said we would do and we did it in a much shorter period of time. The other thing that Roe didn't touch upon, which is an interesting dynamic that's happening now internationally, governments are -- when they're looking at programs for women, especially in the screening side, they're looking at cervical cancer screening and they're looking at mammography screening. And we've seen, and we're having conversations with certain governments relative to combining our mammography with cervical cancer testing, and we find ourselves in a very unique position to do that. And whether it becomes an HPV or it becomes a Pap test, we're -- we can play in both areas and bring the best mammography [ph] to the market as a combination in a tender.

[Rohan F. Hastie:]

I'm sorry. I should add there. So you are correct that the write-down more due to Third Wave and Gen-Probe, and as we said, we really think this is a little bit of an accounting exercise. We have a slight change in the outer year growth rates, reflective of a bit of a slow start in FY '13.

[Operator:]

And our next question comes from Glenn Novarro from RBC Capital Markets.

[Glenn J. Novarro:]

Two questions. First, can you clarify your fiscal '15 guidance? Are you saying low single-digit revenue growth and mid-single-digit EPS growth? That's my first question. And then second, can you give us an update on government reimbursement for tomo? I know, Jack, on the last call, you said you had been going down to D.C. a lot. Any up there would be -- any update would be great.

[John W. Cumming:]

Glenn, why don't you handle -- I'll handle reimbursement side and you...

[Glenn P. Muir:]

Yes. As it relates to FY '15, Glenn -- I mean, we believe after FY '14, there will be a return to growth. So when we look at our revenues and our earnings, we believe that both top and bottom line will be low to mid-single-digit growth.

[John W. Cumming:]

Okay. And let me talk about reimbursement for a minute. We -- first of all, we had a little problem going to Washington. Somehow when we got there, everybody had left town because they'd shut it down. But now that they are kind of slowly coming back, we continue to have conversations with CMS. We continue to work kind of a three-pronged attack there, dealing with the legislative side, the private payor side and CMS. And I think we have to work all 3. CMS is kind of constrained in that there is so much going on right now with the ObamaCare. I'm not sure that they're in a position to make decisions relative to a lot of the different projects before them right now. But we have been very encouraged by the legislators that have taken a very active role in dealing and talking to CMS for us, because the fact they are -- they believe, and have read all of the documentation. They have talked with physicians who have come to Washington about the benefits of tomo from just a pure catching cancers early to the economic benefits. And hopefully, we can get CMS to kind of move off the dime and do something here. But there is certainly some frustration on our side. But on a today basis, what we can do is continue to push on the private payor side; and that's where we're putting a great deal of our energies now because that is, whether it be some of the larger ones on a regional basis that are paying $30 to $70 for a mammogram right now or the fact that we've had a group in Florida right now, approve a plan for reimbursement, specifically for tomo. These are all very positive things. It's going to take time in CMS side, and we cannot wait for them. So we have to continue to push on the payor side and continue to work the legislative side and hopefully, CMS kind of comes up for air. And we're working with ACR. We've talked with AMA, so we're trying to hit all of the levers that we can on this.

[Operator:]

And our next question comes from Jon Block with Stifel.

[Jonathan D. Block:]

I just have 2 quick ones and maybe the first one is a follow-up to the last comment. Jack, do you think you have a notable commercial win on the reimbursement side for tomo in 2014?

[John W. Cumming:]

I really can't answer that. I don't know. I think the win that I know about is the one-at-a-time insurance companies that we're picking off. I mean, we have a team out there talking on them. As far as CMS goes, I think I said this in the last call, I gave up long ago trying to bet on what's going to happen with the government agency. So I got -- I have to unfortunately defer to that, but we'll continue to push the legislative side in the meantime and push with CMS. We're hoping. I guess that's all we can say at this point.

[David P. Harding:]

And this is David, just to add. I think the important thing to note is that about 60% of the institutions that are submitting claims to their insurance companies are, in fact, getting reimbursed at these incremental levels that Jack talked about, between $30 and $70. So there is already good payment history that is occurring even without major reimbursement policy decisions at this stage.

[John W. Cumming:]

And you have a second question or is that the question?

[Jonathan D. Block:]

Another question. You talked earlier about the stabilization in the pap business as we enter 2015. I think you also alluded to NovaSure. Can you just talk to, big picture, what's going to unwind from '14 to '15 that will allow that high-margin business to stabilize?

[John W. Cumming:]

Okay. I'll let David handle certainly on the surgical side. But I mean, as I did say on my talk, we have made some changes in leadership on the surgical aside and added some very talented people. We have also looked at how we're selling and we've looked at that sales force and how it's organized today, and we think that, that is going to have an impact in driving future sales. But David, go ahead.

[David P. Harding:]

Yes. On the NovaSure side, I think we've mentioned to you earlier that there are lower-cost alternatives that are out there in the form of hormone-eluting IUDs and the like and those have been taking some share away from NovaSure. But we do see that kind of bottoming out in the 2014 period. We also see our international business continuing to grow and offset some of that. So that's why we believe that in addition to our sales force activities in getting more effective on the sales force side, we will see it kind of flatten out and then start to stabilize a little bit more in 2015.

[John W. Cumming:]

And on the ThinPrep side, Roe, do you want to handle that?

[Rohan F. Hastie:]

Yes. Just -- I just think that the penetration of adoptions will -- for last year and this year is when we will see the maximum amount of adoption, and we certainly expect that to fall off as that rate becomes much more fully penetrated within the market, and we predict that, that will be within the 2015 period. Again, to reiterate, I think we will still see some margin expansion within that timeframe. I just don't think that it will be at the rates that we've seen over 2013 and 2014.

[John W. Cumming:]

I guess I should add to surgical. I mean, we'll be introducing product enhancements, new products and that sales force realignment, we believe, is going to be a key to the growth -- to the return of growth on the NovaSure side.

[Operator:]

And our next question comes from Richard Newitter with Leerink Swann.

[Richard Newitter:]

Jack, just on that last point, just can you maybe clarify how much of the return to low to mid- single-digit growth in fiscal '15 is contingent upon kind of fact as you feel like you have control over versus underlying improvement in the market? It sounded like a blend there, in Surgical, for example, that you have some new products and the sales force alignment; and in ThinPrep, it's a little bit more cervical interval expansion. Can you get to low and mid-single digits if some of the macro factors don't turn?

[John W. Cumming:]

I think we can. Unless we -- I mean we have really vetted these numbers in coming up with our estimates, we thought that they were very realistic for this year. We weren't sandbagging. We looked at the process last year. We looked at the process this year. We changed the process from certainly a bottoms-up review, and we needed to stress test that several times. When you look at the tomo, when you look at the uptake in assays, when you look at the incremental business that's going to come from Quest, when you look at what's going to happen on the new biopsy side, we see there's all very good positives to help drive this growth. We also have 3,000 plus Selenias out there, 7 to 10 years old that need to get replaced and they're going to start really getting replaced from the 2015 on, so we believe that those are also positive. Those secular kind of headwinds of the interval on the ThinPrep side. We really -- we've gone heavy on the discount this year and we believe it is going to start to flatten out, which then, of course, we're coming from a different base, which will allow the other products that are growing to kind of offset that and emerging to those single digits we talked about.

[Operator:]

And our final question comes from Amit Bhalla with Citi.

[Amit Bhalla:]

Jack, as this discussion of the longer-term growth rate of the company has been beaten around, I was hoping you could talk a little bit about the leverage in the business. Because it doesn't sound like when you talk about '15, '16, there's much in terms of leverage from the top to the bottom line. And maybe put that into context of some of the improvements you're trying in supply chain. And then secondly, for fiscal '14, what is the overseas Diagnostics business going to grow in the context of overall Diagnostics down mid-single-digits?

[John W. Cumming:]

Okay. I think we have a variety of people who'll be handling this one. I think Glenn will get involved also. Certainly, the EPS is going to outpace revenue. And from a standpoint of just international and general, I think I'll let David handle that because that's kind of a very bright spot for us right now. It has helped to offset the decline in the U.S., certainly of ThinPrep and of Surgical, and we just completed it. It's very timely because Roe, myself and David just came back from our international sales meeting overseas where we had all of our people in from the Diagnostics and the Surgical side. So we can kind of report back to you on that. David?

[David P. Harding:]

Yes. So on the international side for the Diagnostics piece, in particular, we expect modest growth that will help to offset some of the domestic decline on the Surgical side of the business, again, growing very rapidly, good double-digit growth there; and again, on the Breast Health side, growing solidly in the sort of mid-single-digits range. So the international business will grow. It won't completely offset all of the declines in the U.S. on the domestic side to be sure but -- and nor will in the Surgical side. But it is a very important component of our future growth in all aspects of the business.

[John W. Cumming:]

Roe?

[Rohan F. Hastie:]

Yes. And I mean, I would add from the Diagnostics side that there remain continued opportunities for us in both ThinPrep and HPV as different countries are evaluating, expanding their cervical cancer screening offering. So whether it's an HPV primary, with a reflex cytology or lead with cytology with a reflex HPV, we feel there's an opportunity there for us. I think from the molecular side, that Panther platform is -- the market is much more fragmented within Europe and other areas of the world for that matter, but the Panther plays exceedingly well within those market segments, and I think we're just starting to see some really good traction with instruments placements for Panther there as well. And then as the other element, which we don't tell much about, is we're certainly hopeful of strong international blood screening opportunities for us for countries that are looking at instituting blood screening for donations or, indeed, some potential share shift internationally as well. So I think we're feeling very optimistic about 2015 from the diagnostic sector.

[John W. Cumming:]

And from an organizational standpoint, the international infrastructure is really in place. I mean, we're making a few adds, certainly, to the management right now. But service efficiencies, I think, are going to start to come online in '14, especially on the Gen-Probe side as we put these programs together and trying to do cross-training. And there's going to be manufacturing changes in our capital equipment, that is all part of this remanufacturing delivery of our service, delivery of our application service. So we're making a huge push in that area, which we expect to start seeing the benefits in '15.

[Operator:]

Thank you, and that is all the time we have for questions today. This now concludes Hologic's Fourth Quarter Fiscal 2013 Earnings Call. Have a good evening.