Hologic Inc (HOLX) 2010 Q1 法說會逐字稿

Good afternoon and welcome to the Hologic Inc. first quarter fiscal year 2010 earnings conference call. My name is Rebecca, and I am your Operator for today's call. Please note today's conference is being recorded. All lines have been placed on mute.

I would now like to introduce Deborah Gordon, Vice President, Investor Relations, to begin the call.

Thank you, Rebecca. Good afternoon and thank you for joining us for Hologic's first quarter fiscal year 2010 earnings conference call. I encourage everyone to visit Hologic's Investor Relations page of our website in order to view the PowerPoint presentation related to the comments that Glenn Muir, Hologic's Chief Financial Officer, will be making in his opening remarks. The replay of this conference call will be archived on our website. Please also note that a copy of the press release discussing our first quarter results as well as our second quarter and fiscal year 2010 guidance is available in the Investor Relations section of our website under the heading Financial Results.

Before we begin I would like to remind you of our Safe Harbor statement. Certain statements made by management of Hologic, Inc. during the course of this conference call may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements of Hologic to be materially different from future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors include, among others, those details from time to time in the Company's filings with the Securities & Exchange Commission. We expressly disclaim any obligation or undertaking to publicly release any updates or revision to any forward-looking statements to reflect any change in our expectations or any change in events, conditions, or circumstances on which any such statements are based.

Also during this call we will be discussing certain financial measures not prepared in accordance with Generally Accepted Accounting Principles, or GAAP. A reconciliation of these non-GAAP financial measures to the related GAAP financial measures can be found in Hologic's first quarter 2010 earnings release including the financial tables in the release.

Please note that today's conference call will consist of approximately 30 minutes of opening remarks from management followed by a 30 minute question and answer session. We therefore ask each participant to limit his or her questions to just one with one follow-up, as necessary.

I would now like to turn the call over to Mr. Rob Cascella, President and Chief Executive Officer.

Thank you, Deb, and good afternoon. Thank you for dialing into our conference call. Joining me on the call is Glenn Muir, our Executive Vice President and CFO; Jack Cumming, our Chairman, who's dialing in from China; Howard Doran, Head of our Diagnostic Group; and Steve Williamson who was recently appointed to head our GYN Surgical Group, replacing Tony Kingsley. All of us will be available during the question and answer session.

I would like to take a minute to introduce Steve Williamson. Steve worked very closely with Tony in running all aspects of the Surgical business over the last several years and most recently led our GYN Surgical sales and marketing efforts as Vice President. Prior to this, Steve was part of Cytyc's sales and marketing group and came to that company with the acquisition of Novacept in 2004. As you can see, Steve is extremely familiar with all areas of the Surgical Group and has been critical to the success of the business thus far.

Our agenda for today's call is as follows. I will review our business performance in the recently completed quarter and Glenn will discuss in more detail our first quarter financial results as well as provide our guidance for the second quarter and full year. We will then open up the call for Q&A. As Deb stated we will conclude this call in about an hour.

I am extremely pleased to report that once again our quarterly revenues and adjusted earnings exceeded our guidance. As stated in our earnings release, Q1 2010 revenues were $412.4 million, a 3.9% decrease from Q1 of '09 but up 2.4% sequentially from Q4 of '09. This compares favorably to our guidance of $400 million to $405 million. While revenues were down year-over-year because we did not realize the full impact of the declining economic environment until the second quarter of fiscal '09, the out-performance relative to guidance was due largely to better than expected results within our Breast Health segment. During the quarter we also posted a record level of revenues for GYN Surgical and experienced growth in Diagnostics with Cervista HPV, international ThinPrep sales and a record quarter of increased imager adoption.

We also realized continued growth in our recurring service revenue stream. Our revenue mix continued to shift towards an increased contribution from service and consumable businesses, namely diagnostics, surgical and breast biopsy, which collectively now represent approximately 76% of our revenues. For the quarter non-GAAP earnings per diluted share were $0.29, exceeding our guidance range of $0.24 to $0.26. This compares to our non-GAAP EPS of $0.31 for the same period last year, a decrease of 6.5% due to lower revenues year-over-year.

I would now like to review our revenue performance in each of our four business segments. In Breast Health we recorded revenues of $179.1 million, a 10% decline from $199.1 million for the same quarter from a year ago. The decline was due to lower Selenia unit volume and the product mix shift to less featured systems when compared to last year, something we have talked about for several quarters now. In addition, we had $7.5 million less in revenues in the current quarter compared to the same quarter last year as a result of our phasing out the two products discussed more fully in our earnings release. However, we did better than originally expected and achieved sequential quarter over quarter growth for the period. The continued promotion of our more economic Selenia configurations has allowed us to more deeply penetrate lower volume US based sites as well as developing markets abroad. Over the next six to twelve months we expect product mix to favorably change as more higher end dimensions 2D systems are sold into the replacement market. Until such time, we remain focused on market share gains and reducing the cost structure of the product. In addition to digital mammography, we also experienced strong increases in our Aviva and Celero breast biopsy product lines as we continue to take share in the stereotactic and core needle markets. Finally, our service business experienced continued growth from the increasing annuity of our install base of Selenia systems.

Regarding the market for digital mammography systems, we are seeing some increase in hospital capital spending which is evidenced by bookings, performance, and backlog over the last two quarters compared to the majority of the prior year. It should be noted this may not yet be a trend change but we are encouraged by what appears to be early signs of stabilization. The recent addition of routine mammography exams for women over 40 in the currently proposed healthcare reform bill is positive in that it reaffirms what medical evidence has demonstrated over the years that routine screening and early diagnosis of breast cancer saves women's lives. We believe this represents yet another direct contradiction to the task force study released in the fall of last year.

In Diagnostics we posted revenues of $140.4 million, an increase of 4% versus $134.6 million in Q1 of '09 with all of our major product lines up nicely in the quarter. Cervista HPV test volumes have nearly tripled from the first quarter of last year as the newly secured accounts from the past few quarters began to ramp up test volumes. We are very pleased with the progress of our rollout thus far and believe the level of market penetration is consistent with our business objectives. Global ThinPrep sales rose year-over-year paced by strong volume internationally and a higher percentage of imager penetration. We're very pleased that imager adoption once again increased to a record level as measured by a higher percentage of ThinPrep tests imaged.

In GYN Surgical revenues totaled $71.4 million, an increase of 5.2% compared to $68 million in Q1 of '09 and over 6% sequentially. This is the result of strong US sales of our NovaSure devices and growth internationally. This marked a record quarter for both the GYN Surgical business unit and NovaSure. We're pleased with the growth in procedure volume and remain focused on office based penetration. We're convinced greater office penetration is a key element to growing this market and are putting initiatives in place to accomplish same. Adiana system sales contributed slightly to revenues as the product remains in limited launch mode while yields continue to improve at our Costa Rica facility. These efforts are progressing well, and we expect to be increasing our launch activities in the second and third quarters.

Skeletal Health revenues totaled $21.5 million compared to $27.5 million in Q1 of '09, a decline of 22% and down $500,000 sequentially. This decrease was primarily the result of decreased systems sales of our osteoporosis assessment products and to a lesser extent mini C-arm products, both of which continue to be impacted by the economic environment and ongoing effects of reimbursement reductions for osteoporosis assessment.

Turning now to highlight certain of our key new products, let me first start with an update on Cervista HPV tests. After launching the Cervista product line in the latter part of fiscal 2009, the many accounts we have signed have resulted in a steady acceleration in testing volumes. We also continue to sign new labs and are focused on increasing test utilization within current customers. We remain very pleased with the strong momentum among physicians and labs and the solid progress we have made in gaining market share. We remain very optimistic about Cervista's potential as a key growth driver to our revenues. During the quarter we released our first phase of workflow processing involving file to plate transfer and extraction. We believe this first phase of automation will be compelling to high volume labs using DNA based molecular assay tests.

We have expanded the launch activities for the Adiana product. During the second quarter we will continue to train doctors and scale up our manufacturing in Costa Rica so we can adequately support demand. In fact, we're on track to train more doctors in the second quarter than we trained in the first quarter. We remain confident in the market opportunity which has been confirmed by the early feedback we have received from those clinicians who have used the product.

During the quarter we completed a couple of other potentially significant product additions in our GYN Surgical business. The first is FDA approval of our second generation NovaSure device designed to improve ease of use and reliability. We believe this is the first of a series of product improvements designed to maintain our market leadership for this very important growth driver to the Company. The second is the introduction of our new tower free hysteroscopic device. This product fits exceptionally well within our surgical product portfolio and complements the expanded use of both NovaSure and Adiana by providing a unique technology that specifically supports our strategic initiative to drive more minimally invasive gynecologic procedures into the office.

Finally our ThinPrep integrated imager system which received CE marking approval in late September was successfully launched in the December quarter to international markets. Given the strong growth we are experiencing internationally with ThinPrep we expect the imager to be a meaningful contributor to our diagnostic business and to accelerate adoption of our technology.

I would now like to provide an update to you on US regulatory strategies for tomosynthesis. We'll still working on multiple clinical trials designed to enable us to provide a wide range of clinical data to the FDA, in part to hedge our bets and provide the Agency with alternatives relative to the product's indications for use. This approach is intended to provide a series of product and procedure configurations addressing both screening and diagnostic indications. In terms of our conversations with the FDA regarding these trials, we believe we have considered thoroughly the alternatives necessary for approval. So our trial strategy is partly intended to anticipate any future requirements the FDA may have of us, as well as to build a very strong clinical package that will serve as a competitive advantage and barrier to entry into the marketplace. We remain optimistic these trials will enable us to go to panel with robust data and meet our goal of obtaining approval in fiscal 2011.

As we have discussed in the past, international is an important part of our growth strategy for the future. Although we have been successful with growing our international business, we firmly believe there is greater potential in existing markets with new products and in emerging markets with existing products. In order to execute on this fundamental part of our growth strategy, we have realigned management appointing David Harding as Senior Vice President and General Manager of International. Most recently David ran our interventional breast business but in the former Cytyc organization was responsible for International. David brings extensive experience and strong strategic thinking to this initiative. Over the next few years international will prove to be an important contributor to the overall growth for Hologic. As such, we intend to leverage the potential of our current successes by applying both resources and in country specific products to the mix. In addition, we will add infrastructure where revenue potential justifies and look to cultivate emerging markets where longer term growth can be realized.

In summary, I am encouraged by Hologic's first quarter performance and believe we are off to a good start. We continued to see growth in our core products, nearly tripled our Cervista volume over the last year, had a record quarter for Surgical and experienced an increase in sales of our Selenia systems as compared to the last three quarters, all of which resulted in our exceeding the guidance for the quarter.

With that let me turn the call over to Glenn to provide the first quarter financial details and guidance for the second quarter and full year of fiscal 2010.

Thank you, Rob. As Rob stated, we are pleased with the revenue performance in each of our segments. Our mix of domestic and international product sales continues to be approximately 80% and 20%. Foreign currency translation had a modest positive impact on our reported revenue growth of less than 1% year-over-year primarily within the Diagnostics and Surgical segment as most of these international sales are denominated in local currency.

Turning to the rest of the P&L, our gross margins on a non-GAAP basis were 63%, up 140 basis points from the fourth quarter and up slightly versus 62.5% last year. This excludes $43.5 million of amortization of intangibles and is higher than our guidance range of 61% to 62%. The year-over-year improvement in gross margins was due primarily to product mix favoring higher margin disposable products and improved service margins. On a GAAP basis gross margins were 52.5% versus the 51% to 52% we guided to. Our operating expenses on a non-GAAP basis of $130.4 million, primarily excluding amortization of intangibles of approximately $13.6 million, came in above our fourth quarter non-GAAP expenses but within our guidance range of $130 million to $133 million. This expected increase from Q4 '09 primarily resulted from increased sales and marketing expenses related to RSNA, our national sales meetings, and new product launches.

In the first quarter of fiscal 2010 the Company adopted a new standard that changed the accounting for convertible debt instrument with cash settlement features. The additional charge resulting from the adoption of this accounting guidance was $17.8 million this quarter and $16.5 million in the first quarter of last year. This noncash interest expense charge has been excluded from our non-GAAP results of operations for all periods presented. Absent the acquisition related and other charges, pretax earnings this quarter were $116.5 million. And using our annual effective tax rate at 36%, non-GAAP net income was $74.6 million versus non-GAAP net income last year of $80.7 million, a decrease of 7.7%. We reported fully diluted non-GAAP EPS this quarter of $0.29 versus $0.31 a year ago which was ahead of our guidance of $0.24 to $0.26.

Our total dollar backlog for all of our products was $326 million at the end of December, up modestly from $323 million at the end of September. We once again ended the quarter on a positive note as backlog in our Breast Health segment increased approximately 5% sequentially.

Turning to the balance sheet, during the first quarter we repaid $54.6 million on our $540 million term loan which was borrowed in connection with our acquisition of Third Wave. Thus, we have repaid a total of $420.5 million of the term loan leaving a balance of $119.5 million at the end of the December quarter. As of today our balance has been further reduced by another $22.5 million to $97 million. Our strong cash flows will enable us to pay off this loan well within the two-and-a-half years we originally guided to. We generated in excess of $115 million of free cash flow in the first quarter of fiscal 2010 comprised of approximately $125 million of cash flows from operations less capital expenditures of $10 million.

Of particular note, our cash flows during the second quarter so far have been enhanced by a $70 million cash payment we received on January 8, from KV Pharmaceutical to extend the existing asset purchase agreement with KV relating to our pending sale of Gestiva. In addition, KV will also owe us $120 million payable over a 21 month period after FDA approval of the product.

Moving on to guidance, for the second quarter of fiscal 2010 ending on March 27, we are expecting revenues in the range of $410 million to $415 million, essentially flat with Q1. We expect gross margins of approximately 61% to 62% on a non-GAAP basis. We are expecting operating expenses, excluding the amortization of intangibles, to decrease slightly on a sequential basis from Q1 to $128 million to $131 million or 31% to 32% of revenue. We expect interest expense to be approximately $32.5 million in Q2 including approximately $18 million of noncash interest expense as a result of our adopting the new accounting guidance in fiscal 2010 related to our convertible. Our effective tax rate is expected to be 36%. And we expect non-GAAP EPS excluding the amortization of intangibles of approximately $0.29 per diluted share.

For fiscal 2010 which ends on September 25, based in part on the higher than expected Q1 results, we are slightly increasing both our total revenue and EPS guidance for the year. We are guiding to full year total revenues of $1.64 billion to $1.665 billion which is up from the range of $1.625 billion to $1.65 billion we guided to last quarter. We are also expecting gross margins of approximately 62% to 63% on a non-GAAP basis and non-GAAP adjusted EPS of $1.16 to $1.20 per share. We continue to expect operating expenses in the range of $490 million to $500 million, up approximately 2% to 4% from fiscal '09. We're expecting interest expense to be approximately $125 million including $73 million of noncash interest expense resulting from the new accounting guidance related to our convert. We're expecting an effective tax rate of 36% for the year.

Now, switching to cash flow, in fiscal 2010 we continue to expect to generate over $500 million of free cash flow excluding the $70 million payment from KV, and to pay off our term loan. Capital expenditures are not a big part of our business, and we are expecting CapEx of close to $60 million and depreciation of approximately $75 million for the year.

In summary we are pleased with our first quarter performance and remain optimistic about our market share position, strength of product offerings, and the new products being launched. Nevertheless we remain cautiously optimistic as evidenced by our slight upward revision to guidance and are conservative in our outlook in order to recognize the economy is still in a recovery mode and the impact of healthcare reform remains unknown.

Now with that let me turn the call back to Rob.

Thank you, Glenn. To wrap up, I too am once again extremely pleased with our results. We remain steadfast in our commitment to deliver the finest quality products in the world and uncompromising when it comes to exceeding customer expectations. All Hologic associates believe this to be our mission, and I am convinced it remains our greatest differentiator in the marketplace. Lastly, I would be remiss if I did not emphasize that our longer term view on the growth prospects of Hologic is optimistic given the strength of our technologies, our market leadership, the size of the addressable opportunities we serve and our strong financial position.

This now concludes our opening remarks. We will be happy to answer any of your questions. With that, Operator, please open up the call for Q&A.

(Operator Instructions) Your first question will come from Tycho Peterson of JPMorgan.

Good afternoon. Jumping into a question on the US mammography market, is your view we have hit a bottom on pricing? And can you talk a little bit about your assumptions for pricing and then I know you don't to want give unit numbers, but what it would take to get the high-end and low end of guidance throughout the course of the year?

I think that as we talked about earlier, we think that the market is stabilizing a bit, but it is the demonstration of which is the last two quarters. And there are some anomalies, one being that one quarter was our fourth quarter and the next was that it was the end of a calendar year, and there was a lot of year end budget buying. So I think Q2 will be a good barometer in terms of understanding whether or not we really do have a trend, but we are certainly seeing good order activity, strong order activity. With that, I think relative to pricing we're still penetrating the lower end of the market, so ASPs as a result of that product mix still have downward pressure, but as I indicated in part of my talk, as we sell more product into the replacement market, our view is that they are fully configured Selenia, or 2D Dimensions product which will increase our mathematically calculated ASPs. Namely, our ASPs will start to nudge upward. We don't see that as being significant this year, but we do believe that the volume that would be necessary in order to hit the higher end of our guidance has much more to do with unit volume of the number of mammography systems sold, Tycho, versus a dramatic change in our ASPs.

Okay. That's helpful. And maybe on Cervista, can you just provide us with an update of what the customer mix looks like today and what the reception has been to some of the automation introductions that you have talked about over the course of the year?

Yes, this is Howard. We continue to be very pleased with the progression, both at the physician level as well as the lab. On our last call we indicated that we believed the contracts we had signed up to date and customers that relied, if you projected that out on annualized basis, we felt we were somewhere in the middle single digits from a market share perspective. We think we're actually now more in the upper single digits, so we continue to do well in the marketplace. Automation certainly is key, but there are a lot of other factors that determine when a customer goes in live. It is obviously where they are in their current existing contract. Automation is a key contributor. But, frankly, if you ask me the reason why most labs are taking a strong look at us and those who have made that choice why they did so, it really again has to do with the advantages of the product. The existing competitor, when you go out at the OB GYN level, which, again, is the customer of the laboratory, one in ten results right now they're not getting the test they're ordering. They're either getting back a report of QNS or they're getting equivocals. When you're providing a service to the OB GYN, they would like to have an assay that has much lower QNS rates and does not have the gray zone.

Automation I know has continued to be a focus and we're spending certainly a lot of time and dollars behind it, and it is important. However, I think customer satisfaction of the end result is the most important. That's why customers are switching to us. We're pleased with where we stand on our automation pathway, but I think the folks that are choosing us are choosing us because they want to provide better customer satisfaction to the OB GYN and that's why we continue to take share.

Okay. That's helpful. Maybe one last quick one for Rob. With the organizational changes going on at FDA, can you comment on your level of dialog there and whether you feel like there is stability here to build on?

There are ongoing conversations, Tycho, but they are with some of the new folks that have been assigned to the x-ray products, now a part of the in vitro diagnostic group. I think we will know much better over the next couple of months relative to how stable the organization is, but it is our hope with this latest round of changes in the FDA that we have some consistent personalities that we'll be dealing with over this next year.

Your next question will come from David Lewis of Morgan Stanley.

Good afternoon. Rob, in your prepared remarks at the end you talked about obviously the capital environment to remain somewhat less visible but on the recurring revenue side, which was 76% this quarter, the visibility should be much better. I wonder if you can share with us, given your optimism on new products, what is a realistic range of growth expectations that your recurring business can drive here over the long-term in the next two to three years? Are we talking about a low single-digit number, a mid single-digit number or a high single-digit number?

If I said yes to all of those, David, it would be truthful. There is not one number. I think if you look at our expectations in NovaSure we think that's a significant market opportunity that is $1.5 billion to $2 billion in terms of the addressable market that is yet to be penetrated. We feel similarly about Cervista as well. So when we look at those annuity businesses, we think it is realistic to be in the low single digits. I think the other parts of our businesses that are more mature, like our diagnostic business, we're happy with low single-digit growth in that business and it happens to be a significant business. So on average it will pull the growth factors down on the Company, but on our emerging opportunities we believe low single-digits are most realistic.

Maybe two more quick follow-ups here. First, Howard, if you think about the Diagnostic business in the quarter, if the imager was strong internationally and international ThinPrep is still growing and you're up $5 million year-over-year, what's the implication for what's going on with the US business and can you update us on market share?

You're talking about just pap market share, David?

Mostly. I am trying to figure out if the business is up $5 million, with very strong trends in international imagery and international ThinPrep, it didn't leave a lot of room for US ThinPrep growth so just wondering where share sits there.

We don't think there has been any real significant share shift over the last year or year-and-a-half, David. I think what we have talked about, particularly comparing 2008 to 2009, we definitely saw a softness in OB GYN visits for wellness, and we think we saw a fairly significant impact, as we've talked about before between '08 and '09. We think that has stabilized, so we think we're probably market share neutral to where we were in 2008 and 2009. However, volumes we do believe are slightly up as a result of the economy but it stabilized nicely over the last handful of quarters.

Your next question will come from Peter Bye with Jefferies & Company.

Thanks, guys. Just maybe a question on the Breast Health GM. You gave a couple of comments on the call, but it is a huge reversal from the last three quarter trend even though you continue to be down sequentially. Can you give us a little other color on why that number is so strong?

Peter, we saw some improvement in gross margins across the board, but in particular in the Breast Health segment really as it related to our cost structure. We have been able to drive some costs out of the manufacturing side of the business, especially as it relates to warranty costs on some of the detector internally manufactured items. I think our operations group is doing a terrific job of producing the product at the lowest possible point.

Obviously that suggests it is sustainable. And then the tax line we had 35% for the year. You're talking about 36%. We might have been wrong on that one, obviously. We're wrong on a lot of slots. But are you including the R&D tax credit in your tax rate and you're thinking about more of an international business so can you talk about tax a little bit, not only this year but maybe the longer term trend without giving specific guidance?

As it relates to international, we don't get a huge benefit there,though, Peter, because we're not manufacturing and selling. We're really producing most of the product here in the States or in Costa Rica transferring it back to the States so we don't get the same benefit of international rate. Our international sales are still pretty low. As it relates to the R&D credit, that's not reflected the full year but the first quarter.

Your next question will come from Amit Bhalla with Citi.

Good afternoon. Also sticking along the lines of gross margin, while Breast was strong, the Surgical gross margin, when we adjust for amortization, looks to be steadily dropping for the past several quarters, so can you maybe address what's happening on the Surgical side?

The surgical side on margins is volume related. If we think back to the transfer of that product just about a year ago to the new facility in Costa Rica, there was certainly startup and production costs we had to absorb. I don't think we're there yet. We're certainly not at the type of absorption we think we can be at in the future, especially as is relates to the startup of Adiana but that's being offset by greater improvements on the NovaSure side. So Surgical is another bright spot when we think about margins going forward.

Just to follow up, two quick ones. Tomo -- when do you think you will actually complete these assortment of trials you're doing? And maybe you can comment on where we are today on the replacement market for 2D and where we should be by the end of the year. Thanks.

We have not given specific dates in terms of FDA submissions, but we are holding to an expected approval sometime in 2011. With that, obviously if we back up, there is going to be some submission either early in 2011 or late in 2010. With respect to the second question was?

Replacement market for 2D digital, where are we today, where should we be by the end of the year?

Right now it is probably around 5%. We think that that will steadily grow but will still be in the single digits. I think that what we have talked about in the past that in order to normalize the replacement market, which means it will be 10% to 15% of the install base, it's probably 12 to 18 months out and that is our estimate.

Your next question will come from Thomas Kouchoukos with Stifel Nicolaus.

Thanks for taking my questions. Real quick on the breast biopsy business, could you give some color into the magnitude of growth you're seeing in this business? You held that one out as a grower this quarter. Also maybe comment on the recent developments in the infringement case with J&J.

Yes. On the Breast biopsy front, with the exception of MammoSite which is part of that business unit, the business is growing fairly consistently at somewhere between 15% and 20% a year. We don't give out updates on any of our litigation so unfortunately I have to defer on that.

Okay. Real quick a follow-up. Also the Adeza business is one we don't hear about too often any more. Maybe you can comment on some of the success or where you are with expanding into that high risk market?

Tom, the high risk market, as we've talked about on a couple of previous calls, it is a little tougher sledding, changing the medical practice with that. I would still say that although we made some progress, the majority of the growth that we are seeing would still be coming more from the signs and symptoms. We have talked about it being heavy lifting on the at risk market, but we continue to spend extra focus back in L&D and continuing to make sure we're getting signs and symptoms. Although we're pleased with where we're heading and we continue to see the product grow and we're pleased where it is heading on a year-over-year basis.

From Piper Jaffray we'll hear from Bill Quirk.

Good afternoon, everybody. It is actually David Claire here for Bill. The first questions that I have are on Cervista. Just curious if you can give us some color on the types of accounts that you're adding, if they're new accounts to HPV or if they're competitive wins?

Yes, David. The majority of those accounts are existing HPV users that are moving the business over to Cervista. They are not obviously the national labs but we have labs pretty much in every volume spectrum below that, so we have got a wide array of various laboratory sizes that have made the choice to come and do business with us.

Okay. And then just a quick follow-up on that. Just hoping you can give us an update on the automated HPV instrument. Are the timelines still on track there and when do we anticipate launching in the US and Europe?

We're looking to the summertime for a launch in the US and probably slightly ahead of that in Europe.

Next we'll hear from Jayson Bedford with Raymond James and Associates.

Good afternoon. Just a couple of quickies on Tomo, since you brought it up. Fiscal 2011 approval, does that assume a diagnostic label or a screening label?

We're really going down a combined dual path and it may be either or it may be both, not to be evasive about it. But the elegance of the data that we're presenting would support either indication, so we are testing the waters with the FDA in terms of what they're most likely to want to see relative to approval. We would guess that a diagnostic is probably a bit more manageable from their perspective, but we also tend to have strong and very robust screening data. So without really having the FDA rule on something, our goal would be to have both diagnostic and screening and we believe that the diagnostic may be first but we have no real certainty from the FDA on that matter.

Okay, thanks. Secondly, tomo in Europe, how is that market unfolding? Are you seeing any type of competitive pressuring pricing out there?

The only other company that is selling a tomo product right now in Europe is Siemens and we're not really seeing a lot of their sales activity. In the cases where they are in a competitive situation, they're offering it up and they're offering it up at a relatively low price, but I think much of that has to do with the product not really being ready yet. So they are fulfilling the desire or need on the customer's part for a tomo product but fully knowing that they have a ways to go for that product to be clinically viable. We are selling it into research and to the private sector and we're selling a fully functioning product that we think is garnering some good clinical support.

Your next question will come from Isaac Ro with Leerink Swann.

Good afternoon. Thanks for taking the question. I think you mentioned in the beginning that Jack is over in China. Just wondering if you guys could comment on that market and maybe other emerging market opportunities for your business over the next twelve to eighteen months.

We think that there are many markets, namely one as significant as China that represent good growth opportunities for us in the future. Right now it is probably our second largest ThinPrep market, quickly becoming our largest. And in addition to that, we believe with the appropriate amount of infrastructure that we can also provide a digital mammography offering for that market to penetrate into the ultra low end. Those are things that we have not done thus far, but that's clearly one of our intentions. So what we are looking at is, is there significance in building products in country and providing that as a basis to serve those local markets. But clearly it is an opportunity and it is an opportunity that's happening over probably the next three years.

Great, thanks. Just secondly, looking in the Invader technology portfolio that you have maybe past the current service HPV can you touch on what your expectations are for other pipeline products on that platform in the future?

Yes. We're going to go down a path of something, we'll have a CT&G offering. And in terms of some of the other things that we'll be focused on, it is probably improving upon the current Cervista test more than even a string of other in vitro diagnostics or molecular diagnostics. I think there is a lot we can do to improve not just test results but the efficiency in workflow and that will probably be a resource drain at least when we look out for the next three to five years.

Your next question will come from Amit Hazan with Oppenheimer.

Good afternoon, guys. My first question is a clarification on guidance. If I look at your new fiscal year 2010 guidance versus what you just did in the first quarter, you beat the midpoint of your Q1 EPS by $0.04 but you're raising guidance by $0.01. If you can clarify what's going on there and why the bottom line raise is not going all the way through to fiscal year '10 guidance?

Amit, thank you for that question. I think when we think about -- we were looking more at the year when we think about our guidance. And I appreciate that we did in fact beat guidance I think by $0.03 in Q1, and it is not that it doesn't translate into higher EPS for the full fiscal year but rather that we're still in an early stage of looking at the full fiscal year and we're trying to move the full fiscal year EPS needle forward. So we're trying to rebalance the remainder of the three quarters.

Okay. And on the Diagnostic segment, just to follow up on a question that was asked earlier, in a different way maybe, if we look at things sequentially, your Diagnostic segment increased by less than $2 million, And it is pretty strong seasonality usually between the September quarter and the December quarter. So I am wondering with the growth you outlined and some of the ramping up you're outlining in HPV how we think about sequentially what happened in the quarter and why it may not have been even stronger?

I think, Amit, as we reported in the summary, we have three things that really attributed, and I will put them in ranking order. One is Cervista sales led followed by unit volume internationally, and then followed by imagery penetration. We have had a couple of quarters in the last five where we announced record ThinPrep volume sales worldwide. We had a very, very strong quarter. However, it did not eclipse the highest quarter we have had. It was actually our second highest. So I think what we're comparing is a unit volume that is not to its highest point that it has been offset by three products that performed very favorably for the quarter.

Next we'll hear from Vincent Ricci with Wells Fargo Securities.

Hi, guys. My first question, considering all the discussions you guys have had with the FDA, there is two public meetings coming up this month discussing regulation and reclassification and the entire filing process for devices. I was curious your take on that and any concerns and/or things that you think might be positive coming out of that?

I still think there is ongoing discussions about the whole 510-K process with the validity of that as a filing alternative and whether the FDA -- one of the discussions whether the FDA moves forward with the downgrading of digital mammography. Other than that, I don't think we see anything coming out of the FDA that is going to be more onerous than it already is, and in fact would welcome at least some definition out of the Agency. I think our comment is neutral to positive at this point.

Okay. And you guys gave us an update on where you are with the term loan and you will likely be through with that in the next couple of quarters. Can you just remind us what your uses of cash are after that and also what the timeline is with the convert and any dilutive impact from that?

Vincent, on the term loan we're expecting right now to have that paid off by the June quarter, so it is in the next two quarters. And beyond that the cash flow use for the remainder of the year is really to build up our cash balance. We really haven't addressed the use of our capital allocation as we go into 2011, but we do recognize that that convert will come due in December 2013. The challenge there, though, is it is fairly low cost debt for us, so we're not rushing to pay it off.

The next question will come from Sameer Harish with Needham & Company.

Thanks for taking the question. I wanted to clarify what you said about the market share in Cervista. Were you saying that the high single-digit market share is based on the contract you have in hand or more projected contracts that you expect to have by the end of the fiscal year?

Yes, Sameer. The contracts that we have in hand today, if you take them forward twelve months, the value of that revenue on an annuity basis over the next twelve months would take us to the high single-digit market share which is the same calculation we did last quarter when we said it was in the mid.

Okay. In regards to the adoption of the automation or the semi automation that you released recently, is that pretty ubiquitous across the labs that are looking to adopt Cervista as a whole or is that still early?

Both the products were released at the end of the year so it is still very early on. And what I would say it has done is continued to open more doors to have more meaningful conversations.

(Operator Instructions). Your next question will come from Jonathan Block with SunTrust Robinson Humphrey.

Thanks. Good afternoon, guys. First question on NovaSure, maybe if you can just address the growth rate there. It seemed a little soft. I think constant currency for all of Surgical was just north of 4%. That was double-digit last year, and I am assuming there is a little bit there of Adiana, so maybe just some comments on what's going on in the space specific to Novasure.

Thanks, Jonathan, this is Steve. When we look at the whole GEA market we were actually very pleased with the performance we had in that space this quarter. We set revenue records both domestically as well as internationally, and continue to have overall guidance for GSB of 12% to 15% growth for the year. When we look at this space I think it is an area that we think we continue to take market share gains as well as assist in growing the market with this underserved market that's out there by getting out to patients and doing what we can to drive those patients into the physician's office.

Okay. So it seems like more timing than anything else is what you're saying?

Actually I would say that the quarter was very strong for us. We did see record revenues, as I said, and I think that we'll continue to see growth throughout the year.

Okay. Just over to Breast Health, that was well ahead of our estimate. And maybe, Rob, any commentary around market share between and you and the other three players? We had heard one of the guys stumbled for part of the quarter?

Yes. I don't know if they stumbled. I think that we have stayed pretty steadfast relative to focusing on share, and I think we have been running somewhere north of 60%. I think we may have maintained or perhaps nudged up a bit on that. We are consistently winning on all of the deals that are being presented to us. I am sure that we're losing some that we are unaware of but feel pretty confident that the product has been doing well and we are highly competitive at this point point.

Thanks.

Your final question will come from Matthew Scalo with Canaccord Adams.

Hi, guys. Thanks for taking the questions here. The first one, Rob, I thought you mentioned you put plans in place to help penetrate the physician office with the NovaSure product. Are these new plans, additional head count, just incremental marketing spend on that side of things that differ from previous quarters that we should be aware of?

Yes. I think one of the things that we have been focused on is how do we assist in the surgical services side, namely anesthesiology. And we are looking at ways of supporting a partnering of anesthesiologists and GYN surgeons really around the country. But we are launching very limited pilot programs in selected markets to test our hypothesis that that is a driver on further adoption and market growth. In markets where that growth has occurred naturally, our office penetration is double that of what the national average is. So we think that the test case would certainly give a strong indication that we want to continue and further that level of support. I don't think it is a tremendous amount of money for us to do it. It will invariably cause us to have to put some dollars to work. Our goal is to try to create reference centers around the United States.

Okay, terrific, thanks. Just a follow-up question, switching gears to the MammoSite and now the launch. I know it was early September, probably had no impact on the quarter, but what should we expect sequentially in this March quarter?

For MammoSite specifically we're looking at gaining back some market share and incrementally over the course of this year. I don't know what the specific numbers are given the newness of the product and our requirements for a lot of extensive training. The feedback has been excellent. I think it obviously meets all of the criteria necessary for both reimbursement and clinical adoption, but quite frankly it is just a little early for us to tell at this point.

Okay. Thanks, guys.

Thank you. That is all the time we have for questions today. I would like to turn the conference over to Mr. Cascella for his closing remarks.

Thank you. To wrap up, I once again am extremely pleased with everything that's happened in the quarter, really appreciate that everyone is joining and all of the questions. And with that we'll end our call for this evening. Thank you very much.

Ladies and gentlemen, that does conclude today's presentation. We thank everyone for your participation.