Hologic, Inc. (HOLX) Q4 2007 Earnings Call Transcript
Published at 2007-11-06 18:58:49
Jack Cumming - CEO Pat Sullivan - Chairman Jay Stein - Co-Founder and CTO Rob Cascella - President and COO Glenn Muir - EVP and CFO
Amit Hazan - CIBC World Markets Glenn Novarro - Banc of America Tycho Peterson - JP Morgan Ed Shenkan - Needham& Company Mark Richter - Jefferies Amit Bhalla - Citi Isaac Ro - Leerink Swann Jayson Bedford - Raymond James Thomas Kahn - Kahn Brothers Bruce Jackson - RBC Capital Markets Junaid Husain - Soleil Securities Andy Schopick - Nutmeg Securities
Welcome to Hologic Incorporated Q4 Fiscal Year 2007 EarningsResults Conference Call. Today's conference is being recorded. Before we begin, management of Hologic Inc. has asked thefollowing statement be read. Certain statements made by management of HologicInc. during the course of this conference, may constitute forward-lookingstatements within the meaning of the Private Securities Litigation Reform Actof 1995. Such forward-looking statements involve known and unknownrisks, uncertainties and other factors, which may cause actual results,performance or achievement of Hologic to be materially different from futureresults, performance, or achievements expressed or implied by suchforward-looking statements. Such factors include among others, those details from time-to-timein the company's filings with Security and Exchange Commission. We expresslydisclaim any obligation, or undertaking, to release publicly any updates orrevisions to any forward-looking statements, to reflect any change in ourexpectations, or any changes in events, conditions or circumstances, on whichany such statements is based. At this time, for opening remarks and introductions, I wouldlike to turn the call over to the CEO, Mr. Jack Cumming. Please go ahead sir.
Well thank you Sharon,and good morning, everybody. Thank you for attending our fourth quarter andfiscal 2007 year-end conference call. Joining me on the call this morning is Pat Sullivan, ourChairman; Jay Stein, our Co-Founder and Chief Technology Officer; Rob Cascella,our President and COO; and Glenn Muir, our Executive VP and CFO. And beforeproceeding I need to remind you of the Safe Harbor statement accompanying ourpress release applies to comments made during the call. We are very pleased to share with you our fourth quarter andour fiscal year-end financial results for the period ended September 29, 2007. I'm going to briefly touchon the highlights, while Glenn will provide further details on our operationalprogress, as well as guidance for fiscal 2008, and we're then going to open up thecall for questions. Prior to discussing our quarterly performance, I would liketo bring everyone up to date on our merger with Cytyc. On October 22nd, wecompleted our merger with Cytyc, thus creating a global leader in women'shealthcare. The product portfolios of Hologic and Cytyc provide some ofthe most advanced technologies in the world, to address the healthcare needs ofwomen. By combining our companies, we are able to leverage the strength of eachbusiness, with respect to complimentary, best in class products, channels ofdistribution and infrastructure development. And I would like to take just a moment to welcome, all theCytyc associates worldwide to our family. Over the past few weeks I have had thepleasure to personally meet with many team members in Marlboro. In addition Ihave attended customer meetings in Scotlandwith our northern European team, traveled to Costa Rica and visit with our enthusiastic team inSan Jose, and traveled to Hong Kong to meet with our Managing Director for the Far East. Cytyc has a team of passionate professionals, and togetherwith Hologic's team, we will reach our shared goal of improving womenhealthcare, worldwide through better detection, improved diagnosis, lessinvasive treatment and therapies, and overall better outcomes. With that, now let me review our performance. I am verypleased to say this marks our 15th consecutive quarter of increased revenue andearnings. All of the Hologic team members did an outstanding job in the fourthquarter and, as a result of their efforts, we were once again able to recordrevenues, earnings, and backlog. Let me take a few minutes to summarize our financialresults. As stated in our press release, fourth quarter fiscal 2007 revenuestotaled $202.6 million, which represents a 31% increase over the fourth quarterof fiscal 2006. Fourth quarter fiscal '07 net income totaled $32.1 million,compared with a net loss of $1.5 million in the fourth quarter of fiscal '06. Fourth quarter '06 results though, included a write-off ofin-process R&D in connection with Suros and R2 acquisition. As anadditional comparison for you, our non-GAAP adjusted net income for the fourthquarter of fiscal '07 increased 132%, to $35.9 million, compared to ournon-GAAP adjusted net income of $15.5 million in the fourth quarter of fiscal'06. For the 12 months ending September 29th, '07, revenues increased 60%, to $738.4million compared to revenues of $462.7 million for the 12-month period infiscal '06. And for the 12 months ended September 29th, '07, Hologic recognized net income of $94.6 million or $1.72per diluted share, compared with net income of $27.4 million or $0.56 perdiluted share for the comparable 12-month period in fiscal '06. Q4 revenue and earnings exceeded our previous record highfor the third quarter of fiscal '07. Mammography and Breast Care revenuesincreased 45% to $165.1 million for the fourth quarter of fiscal '07, compared to$114.2 million for same period in '06. Selenia full-field digital mammography system sales continueto set quarterly records. As you may recall from our last quarterly conferencecall, we forecasted 340 Selenias for the fiscal fourth quarter. Once again wesurpassed our target, by recognizing 351 Selenia systems, as revenue in Q4 upfrom the 193 systems we recognized as revenue for Q4 2006, an increase of 82%. For all of fiscal '07, we recognized 1,189 Selenia systemsas revenue, which represents 114% increase, over the 555 systems sold in '06.Fourth quarter Selenia bookings were solid pushing backlog to 589 systems,which is 30% higher than 455 systems we had in backlog at the end of fiscal'06. Also contributing to quarterly growth was an increase inorders for Hologic's computer aided detection system for digital mammography,and our Suros line breast biopsy systems and devices. Total backlog for allproducts at quarters end was $241 million, which represents a 24% increase overthe $194.7 million backlogs ending Q4 of '06. In summary, whether acquisitions of R2, Suros, AEG,BioLucent, and most recently Cytyc, we have built a company that is larger,stronger and better positioned to serve the healthcare needs of women. We are a company with a unified culture, and a sharedpassion for innovation and growth. Throughout fiscal '07, we have kept thepromises we have made to our customers, our investors, and our dedicated teamof Hologic associates worldwide, that make us the company we are today. Withour established track record we expect further progress and success. And now, I have the pleasure of asking Pat, who I believehas a streak of participating in over 40 consecutive conference calls, for hiscomments and perspective, on moving forward together as one company. Pat?
Thank you, Jack. These are truly exciting times for thecombined companies of Cytyc and Hologic. As Jack mentioned the combination ofthese two companies, creates one of the leading companies in the world with abroad array of products focused on women's health. Over the past several months, I have also had theopportunity to meet with many of Hologic's people in the field. I attended aHologic scientific advisory board meeting, as well as the meeting of theirleading distributors in Europe. In both instances I wascompletely impressed with the people I met, and the dedication they displayed. I am convinced that this merger is a good fit, for bothcompanies, as we start to integrate the businesses and the people together, torealize the future potential of Hologic. From my perspective we are off to avery strong start. The day after the merger closed, we held the first meetingof the new Hologic Board of Directors, and hit the ground running. I was truly impressed at how well the members of the twoboards came together, to work as a very effective board. As noted in the pressrelease, the ongoing patent litigation between Cytyc that we had with TriPath Imagingwas settled. Since the terms of the settlement are confidential betweenthe two companies, I am not at liberty to comment further, other than to saythat we are very pleased that this litigation is behind us. Over the next several months, I will be spending a fair bitof time with Glenn, meeting with investors at upcoming conferences, as well asattending the RSNA in Chicago, andhope to see some of you there. And finally, as we close this chapter in this part of theCytyc story, I would like to personally thank those Cytyc executives and boardmembers who are not moving forward, for their significant contributions toCytyc's success in the past. And to thank those that are moving forward fortheir continued dedication to women's health, under the Hologic banner. With that I would like to turn the call over to Glenn for theupdate on the financial performance. Glenn?
Thank you, Pat. Let me now expand on the financial results.My comments are also summarized in a Power Point presentation, accessible onthe IR page of our corporate website at [hologic].com. My presentation todayincludes certain non-GAAP financial measures and a reconciliation of thesenon-GAAP financial measures to their most [directly] comparable GAAP [enterprises]set forth in the same power point presentation at hologic.com. It was another stellar quarter for Selenia, which just likelast quarter accounted for one-half of our total revenues. Total revenues at$202.6 million were $11.1 million or 6% higher than the June quarter and $48.5million or 31% higher than Q4 September of last year. Selenia sales this quarter continued to be robust, recordingrevenues of $101.7 million, representing over two-thirds of our growthyear-over-year. We also saw continued growth from our Suros biopsy group, whichmore than doubled from Q4 of last year, and our service group, whichexperienced a revenue increase from $23.5 million to $31 million. As wecontinue to capture a higher percentage of service contracts on a growinginstalled base of Selenia. Regarding Selenia, the 351 systems sold this quarter wasabove our forecast at the beginning of the quarter, we had targeted 340. Demandcontinues to outpace our expectations. 287 or 82% of these were sold in the US,and 64 were sold overseas. In addition in the US,260 or 91% of these Selenias were shipped with Digital CAD. The Selenia ASPthis quarter, as with last quarter, are stable. Last quarter I believe therewas a bit of confusion around the Selenia average selling prices and amisconception that ASPs had tumbled. Taking total Selenia revenues and dividing by the numbersold, to compute an average, can result in a very misleading number. Like lastquarter, it is important to realize that calculation is a terrible proxy foractual selling price trends, and can be expected to fluctuate widely. Whenthinking about our ASPs, it is important to note competitive factors arecurrently low on the list. The primary drivers for our seemingly changing ASPs are asfollows: first, the geographic mix. As we sell more internationally, ourmathematically calculated ASP will go down. This is primarily due to the factthat we sell through distributors at a transfer price, who are then responsiblefor most of the service, sales and marketing expenses. So although grossmargins may be lower, operating margins are almost the same as a direct sale. Second: for our product mix, our Selenia line has expandedto include various hardware configuration changes that can affect the totalASP, without affecting the price for the base capture modality. This isespecially true in multi-unit orders, where our customer won't need a fullcontingent of soft copy viewing workstations, or capture devices. And then third: in regards to follow on sales, we arebeginning to see existing digital customers place repeat orders, and they willonly require the base capture modality as they already have the viewinginfrastructure in place. So what does all this mean? Not much from a marginstandpoint. We are disclosing total Selenia revenue, because it doesaccount for one half of our total, and we are disclosing the number ofSelenias, because it has become a standard benchmark. So, we just need to becautious when using these figures to try to derive an average. Much more meaningful is to look at the individual grossmargins on each sale, as we do internally. This strips away the differences inhardware configuration. And for the quarter, our gross margins in the Mammography/BreastCare segment increased to 52.3% versus 49.9% in the June '07 quarter, and 46%in the September quarter one year ago. Our overall consolidated gross margins improved this quarteras well, hitting 48.2% or 49.5% on a non-GAAP adjusted basis, due in large partto the overall increased sales volume, and the continuing shift in mix to thehigher margin Selenia digital mammography sales. As Jack stated, our consolidated net income this quarter was$32.1 million. This increase in GAAP income handily beat our expectations asthe higher level of revenues contributed $32.4 million of additional grossprofit in Q4 of last year. Partially offsetting this was an increase inoperating expenses, also primarily due to the increased volume. Without the acquisition related charges, and stockcompensation expenses, the non-GAAP net income would have been $35.9 million.This works out to an adjusted EPS of $0.65. If now we could look at our largestreporting segment, the mammography/breast care, and compare it on a sequentialbasis to our June quarter, the press release gives the comparison to the yearearlier quarter. This quarter, the revenues from our Mammography/Breast Care segmentaccounted for 82% of our total, up 8% from the June quarter. The increase inrevenues of $11.6 million from June, was primarily due to the increase in thenumber of Selenias sold from 328 to 351, and an increase in Suros consolesales, and biopsy hand piece volume. The increase in operating income was due to the increasedgross profit from the higher revenues, and the operating income as a percent ofrevenues continued to increased hitting 28.2%, up from 24.7% last quarter. Switching to ending backlog, which at September 29th was$241 million, was considerably higher than the $193 million balance from a yearago, and slightly higher than the June balance of $22 million. As Jack stated,the backlog of Selenias rose to a new high, 589 systems, up 52 from the Junequarter, and up a 134 from one year ago. Even though we shipped 11 more Selenias than expected, ourunit backlog increased again this quarter, as we took orders for 403 Selenias.This was a much better booking quarter than expected. Two factors stood out, first: the continued interest indigital mammography in general. This market is continuing to expand, especiallyhere in the United States,and digital has become a standard of care. And number two: Selenia isrecognized as the best of breed digital product out there, and it has allowedus to achieve a 55% plus market share, here in the United States. Also to note this quarter though, is that we benefited fromthe timing of a large single order for 40 systems, which is something we don'tsee every quarter, and probably won't see in the December quarter. In Q1 '08,the December '08 quarter, we will again increase the shipments of Selenias,with the goal of stemming this rising ending backlog. I would now like to provide our outlook for fiscal 2008, ourfiscal 2008 guidance, which ends on September 27, 2008. We have completed our operating budget for FY '08 forboth Hologic and Cytyc, which includes the synergies, integration stats, andrevenue targets on a combined entity basis. On October 22, the day of the merger, we did start with afully vetted operating plan in place. If we start with fiscal '08, we arelooking for total consolidated revenues of $1.7 billion. Basically in fourreporting segments, for the mammography/breast health and the skeletal healthsegment, we are forecasting $900 million in revenue, which represents 22%growth over fiscal 2007, and this is primarily attributable to an increase in Selenias. We are projecting an increase of 261 Selenias from 1,189 inFY '07 to 1,450 in FY '08. In addition, we are expecting continued revenuegrowth from the Suros biopsy group of about $30 million dollars, and servicerevenue growth in excess of $30 million. Second of all, for the other two reporting segments, thediagnostics and the surgical segments, we are forecasting $800 million inrevenue, representing 13% growth over fiscal 2007, attributable to across theboard growth in Cytyc's two FY '08 reporting segments. Their diagnostics, with expected revenues of $485 million,due to imager sales: Adeza, and continued international expansion, and surgicalwith expected revenues of $315 million, due to: NovaSure and also continuedinternational expansion and growing acceptance. It's also important to note that only 49 weeks of Cytyc'sprojected revenues are included in our fiscal 2008 budget. We are missing thefirst three weeks, which resulted in about $35 million in revenues. If thesethree missing weeks were included, Cytyc's year-over-year growth would havebeen closer to 18% and our consolidated growth in fiscal 2008 for revenueswould have been projected to be 20%. Next for gross margins: We are looking for combined grossmargins of approximately 61% to 62% on an adjusted non-GAAP reporting basis.This does exclude the amortization of intangibles included in costs, for which therewill be approximately $105 million in FY '08. Combined operating expenses areexpected to be $515 million to $520 million for the year, and are alsoexcluding the amortization of intangibles, which are expected to be around $35million. Included in the above numbers though, are approximately $15million of FAS 123R stock compensation charges. We have not backed them out ofour guidance, but will indicate what they are quarterly and show them on ournon-GAAP reconciliation schedule in the press release as we currently do. For interest expense, we are forecasting interest expense onthe outstanding $2.35 billion of debt, of approximately $110 million. This is$30 million higher than we were expecting on May 20th, when we announced the deal,due primarily to three factors. First: the overall long term LIBOR rate we are using is abit higher than it was in May. Number two: the credit spread on the term loanis 25 to 50 basis points higher, and number three: we were expecting a lowercoupon equity link debenture, concurrent with the deal close. At this point, weare reviewing our options, [deal on] equity linked debenture fits in nicelywith our capital structure, but have not settled on the timing. The above combined results also reflect the results of Cytycfor only 49 weeks instead of 52 as I mentioned, due to their closing of themerger on October 22nd, and not September 30th, date we had hoped for. It doesmake a difference, as it reduced expected revenues by almost $35 million, andpretax income by about [Technical Difficulty] million. For the year our effective tax rate is expected to be 36%.If we look at shares outstanding for Q1, we are expecting total sharesoutstanding for EPS purposes, to be approximately $110 million. This will belower than the total outstanding, since the shares issued for Cytyc will onlybe outstanding 10 of the 13 weeks. We are expecting the shares outstanding to increase to $126million in Q2 and to $130 million by the end of the fiscal year. This shouldresult in a weighted average, number outstanding of $125 million. This is thenumber outstanding we were expecting in the May time frame. So for EPS based on all the above we are expecting non-GAAPadjusted pretax income, which excludes only the amortization of intangibles of$420 million to $425 million. And our EPS guidance for FY '08 on this adjustedbasis with 125 million shares outstanding would be $2.15 to $2.20. This isabsent the effect of any merger-related charges, such as in-process R&D,which will hit, and will distort Q1. Going back to May though, on the same basis, our guidancewas, at that time $2.35 to $2.40. Operationally, we are a bit ahead of where wethought we would be, looking at the combined results, and are very pleased withthe synergies and targets baked into our budget. The $0.20 disconnect is due directly to two items alreadyidentified. Number one: the higher interest expense cost us $30 million thatwas approximately $0.15 on an after-tax EPS basis. We do believe this drag willbe short lived, as we will be very focused on the rapid repayment of our termdebt, and expect a year from now the term debt itself could be one-half of itscurrent $1.1 million balance. And number two: missing the first three weeks ofCytyc's results and the current budget cost us about $0.05 on an after tax EPSbasis. Switching to Q1, our December 2007 quarter -- our September Q4actual results were a bit better than expected. We are expecting continuedgrowth in revenues in Q1 of '08, on both the Hologic and Cytyc business groupsof just over $5 million each. This would equate to over $10 million insequential growth; however at the same time, we will only recognize in Cytyc'srevenue this quarter ten out of the 13 weeks. At a run rate of about $12 million a week, missing threeweeks is a sizable impact on the consolidated total. So instead of combinedguidance, for this upcoming quarter of $395 million to $400 million, we arelooking at reported revenues of approximately $360 million. On the Hologic side, we are continuing to see growth inSelenia sales. We are expecting to sell 361 Selenias or 10 more than lastquarter. We expect that the Mammography/Breast Health segment will have thelargest revenue increase this quarter. On the Cytyc side, we expect to fold their internationaloperation into the reporting for diagnostics and surgical. Both of thesesegments will then, and are expected to show sequential growth this quarter.Consolidated gross margins are expected in the 61% to 62% range. Combined operating expenses excluding the amortization ofintangibles, are expected to be in the $110 million to $115 million range. Interestexpense, associated with the $2.35 billion of new debt, is expected to beapproximately $30 million for the quarter, and non-GAAP adjusted pretax incomewould increase to $85 million. This includes stock compensation charges of $3million. At an effective tax rate of 36% and with 110 million sharesoutstanding, our EPS for Q1 would be approximately $0.49. However there are anumber of one-time acquisition related charges that will hit Q1, and willdistort our true results. Not included in the adjusted non-GAAP figures above will becharges for; in-process R&D of approximately $320 million, inventory write-upto fair market value of approximately $35 million, and stock compensationexpense of approximately $6 million to $7 million, from the acceleration ofcertain Hologic stock options. These expenses will be identified when we reportour Q1; it will be included on the reconciliation to GAAP in our reportednumbers. And if I could turn it back to you.
Thank you, Glenn. I would like to just kind of look aheadhere. While we've accomplished quite a bit in fiscal '07, we certainly have alot more to go to accomplish in fiscal '08 but as a much larger company. Someof our goals for the upcoming year include, continue to aggressively pursueshare gains for our Selenia digital mammography in both the USand in the international markets. And for the ThinPrep Pap Test and the Imager, we want toincrease adoption across a broader segment of the international markets. ForNovaSure we want to drive more minimally invasive treatments procedures to theoffice from the OR, and for MammoSite, we want to increase awareness of partialbreast radiation as a potential alternative to external beam, which is thecurrent standard of care. An example of one such product is our Solero device. Asyou'll recall, we launched the Suro Celero self-contained hand held core breastbiopsy device, which is already generating significant interest in the medicalcommunity. Beginning last week, 50 MammoSite sales reps joined forces with 30Suros breast care technology reps to jointly sell the Celero, Celero markintroducers and the biopsy kit, as well as their own individual product lines. Each team will have two distinct sales channels withMammoSite sales reps selling to surgeon’s offices, and the Suros breast caretechnology reps selling to hospitals and breast imagining centers. Combined,these two groups will make a significant impact on growing the customer baseheld by Suros. This is a unique product placement opportunity for doctors,patients, and Hologic, and it is only one example. There's a long list ofagenda items for fiscal '08. We are looking forward to our national sales meeting inJanuary where our talented diagnostics and GYN surgical teams will cometogether on driving efficiencies across the spectrum of products we market,including cross-training in products, and new initiatives such as theintroduction of our bone densitometry products into the OBGYN channels. Wedefinitely have some exciting times ahead. In closing, Hologic enters fiscal 2008 as a technologyleader in women's health. We are going to continue to invest in technology, aswe deliver the very best the industry has to offer, across all product lines,while expanding upon future platforms, which will position us ahead of thecompetitive curve. With all of our accomplishments in fiscal 2007, we lookforward to 2008 with great excitement. I'd like to thank the 3,500 Hologic teammembers worldwide, for their continued hard work and dedication to make ourobjectives a reality. We could never achieve our goals without having apassionate and a committed team of associates and we have the best the industryhas to offer. And that is why we are number one. And on a final note: our next conference call is scheduledfor Tuesday morning, November 27. It’ll be held at the Radiological Society ofNorth America Symposium, which will be our fourth analyst day that we holdthere in Chicago If you are planning to go to the RSNA this year, we wouldlike to invite you to our morning presentation, which will focus on new productdevelopments and introductions this year. And if you are interested, call ore-mail us, and we will make sure that you are on the guest list. This now concludes our opening remarks, and I would be mostpleased as will Pat and Glenn, and Rob, and Jay to take you questions. So Iwill now turn the call back over to Sharon,and ask her to key everybody up.
(Operator Instructions) We will go first to Amit Hazan, CIBCWorld Markets. Amit Hazan - CIBCWorld Markets: Hey, good morning guys.
Good morning. Amit Hazan - CIBCWorld Markets: Congratulations on the acquisition closing. I thought maybeI would start just asking: on the Cytyc side, just for a little bit more colorif you can? At least on the growth of some of the product lines we have beenaccustomed to hearing about NovaSure and perhaps Proxima.
That's fine, Pat you want to do that?
Yeah. I think if you look at the overall domestic surgicalproducts, in total it was a 24% growth quarter versus the September quarter oflast year, and [re-look] at nine months was about 30% growth. In totalsurgical, we did see a relatively seasonal quarter in the September quarterwith NovaSure being slightly down from where it ended the second quarter. Amit Hazan - CIBCWorld Markets: And could you answer the same question in terms of theguidance you provided?
Yes, Amit its Glenn. You mean the earlier guidance on… Amit Hazan - CIBCWorld Markets: In terms of the fiscal year '08 guidance, just trying to geta sense, if you are looking at Cytyc surgical and Cytyc diagnostic, what'smaking up some of the growth there?
Well, when we think about, let me try to help a little bitthere and it gets a little bit difficult with fiscal year '08, because thereported results are going to be hindered a bit by losing these three weeks.And…
Glenn let me interrupt for just a second. Also, when we goto the four reporting segments in it what you are going to find surgical is notan apples-to-apples, as it was before, because MammoSite is moving out of thatgroup into our interventional breast health group, with Suros. So it will no longer be part of surgical. So it won't be apples-to-apples,but we did have a good increase this quarter domestically in the surgicalproducts group about 24%. Glenn, I am sorry to interrupt.
That's okay. That helps. If we look at it though, Amit, andwe look at the guidance we're giving for as Jack said, the two segments thatformerly were Cytyc, both the diagnostic and surgical and expect for a momentthat with some of restructuring the reporting has changed, that those segmentswill include international in the future. So those two segments we're looking at, to comprise $800million of the $1.7 billion we are projecting for '08, and if we look at thediagnostics, that piece would be $485 million, and that is growth. That is 18%growth over FY '08, and is being driven by, here in the United States, imagersales, internationally by ThinPrep in general, and then both domestically andinternational, by the full term product itself. So all lumped together, you are looking at the mid-teen, asa percent growth for diagnostics. And it's a similar story with the surgicalthough. The surgical in FY '08 is expected to be about $315 million. That's onlybeing dominated by the NovaSure procedure itself, both here in the US,and also beginning to get traction international, as we expand outside the USand see some growing acceptance. I don't know if that helps. Amit Hazan - CIBCWorld Markets: It does and I will follow up off line, but can you, just interms of Adiana, or Gestiva: do you include either in your guidance? And whatis your expectation for Adiana approval?
The Adiana approval. Well Pat, why don't you go?
We submitted that, as I think we indicated on our last callin August of this past summer, and would expect a panel some time in mid-December,followed by an approval in the February, March time frame. So we would start tolaunch the product at that point of time, and I think we have relatively littlein terms of guidance for the Adiana product for next year. Gestiva, I don't think we have anything in that, we are inthe middle of an animal study that we expect to wrap up an approval would be inthe -- about the calendar third quarter of next year.
There are no numbers in there for Gestiva for '08 and, asPat said, very minimal for Adiana. Amit Hazan - CIBCWorld Markets: Great, and one final question, and I'll jump back in queue.Glenn in terms of the guidance you provided for EPS, versus the guidance yougave in May, just to be clear: from all the work you have done, the only tworeasons that the guidance is lower, is because of the interest expense andCytyc not contributing the full fiscal year? Is that correct?
Yes, that is correct. Those are the two differences andactually from an operational standpoint. We are quite pleased with where weended out, or came out with a combined budget. So unfortunately the two knocks,when we look back to May were those two items. Amit Hazan - CIBCWorld Markets: Okay. Thanks very much guys.
We’ll go next to Glenn Novarro, Banc Of America. Glenn Novarro - Bancof America: Hi good morning guys. Two questions, one regarding theguidance, the lower guidance, $0.15 was due to higher interest expenses. Andthen Glenn, you said that you are still looking at some sort of equity-linkedproduct. If you were to do an equity-linked product, let's say in the nextseveral months, would that $0.15 drag be reduced and what's your best guess asto what it would be reduced by? That's question one. And then secondly: you had a very good quarter with Selenia andthe backlog. Can you giver us a sense of, was that market share gain, growth? Anycolor that you can give us. I think in the past you said that you pretty muchare capturing 55% of all placements. Is that consistent? Thanks.
Okay Glenn, thanks. I will let Rob answer the question onSelenia, since he is out on the road making every single one of those sales andI will stick with the interest expense on the $0.15. In that $110 million, isbaked in, later in the fiscal year, some kind of lower coupon rate, than whatwe currently have on the term. So we have baked a little bit in; however, I will admit weare probably being a bit conservative with that number, so that it at leastdoesn't come in higher than that. And I would have to say, that there isprobably a little bit of leverage, if we have a nice placement of some otherequity linked debenture out there, and we're successful as we intend to be, inpaying down the term loan, maybe even a little bit faster than we wereexpecting. And I even alluded to that, in that even though we arestarting with $1.1 billion of term loan, I do believe that we are in a goodposition that we can get that paid off in half. Some of it might be arestructuring or replacement, but nonetheless, almost in half by the end thefiscal year and that could be helpful to this $0.15. But at the moment I think weare just comfortable with that $0.15, Glenn. Glenn Novarro - Bancof America: Okay, great.
Glenn, on the Selenia backlog, Rob is going to answer that,but I am elated to find out that he has been involved in every single sale,because now Jay and myself and Tom mumble and a lot of our folks, we are justgoing to kind of pack it in and for the rest of the year, sit back and run thebusiness while he's out there.
I may have over reached a bit on that, I am sorry.
Thank you, both. Glenn on a serious note, I will try torespond. We had a very strong quarter relative to just market interest, I thinkthe digital mammography market continues to grow, and there is deeperpenetration on many, many fronts. I think that, linked with the fact that it was our fourthquarter, a lot of sales, compensation plans have threshold pricing and triggeramounts. That drove some business as well. The large single order, we'reviewing as a, we are very happy and pleased that we've received that. But weview that outside of our trend and somewhat of an anomaly. From a market shareperspective, I think our new bookings versus revenue we're probably north of60%. Glenn Novarro - Bancof America: 60.
60, yes. Glenn Novarro - Bancof America: Okay. So you are starting to take market share from GE. Onelast thing, that 40 unit placement: was that part of the original guidance interms of Selenia orders that you gave three months ago?
No. No, that was not. Glenn Novarro - Banc of America Okay, alright.
We had a strong quarter without that. Glenn Novarro - Bancof America: Okay. Great, thank you.
We will go next to Tycho Peterson, JP Morgan. Tycho Peterson - JP Morgan: Hi, Good morning. Thanks for taking the call. Hey, Rob.Maybe following up on that last line of questioning, on the call there was somediscussion about multi-system orders and repeat orders. Can you just give us asense of: how many of your orders today are either multi-system or repeatorders with existing customers?
Sure. We are seeing a much higher percentage of multi-systemorders and also customers are coming back to fully convert to digital. I wouldguesstimate at this point and we are probably talking about somewhere in thearea of 40%. It could be a bit higher, but that may be a fourth quarterphenomenon as well Tycho, but we are seeing larger orders than originallyexpected, from a broader range of customers, and for the first time, we areactually seeing multi-system orders from outside the United States, whichtypically has not been part of the trend. Tycho Peterson - JP Morgan: Is that predominantly Europe?
Yes. Tycho Peterson - JP Morgan: Okay. How about, are you also seeing competitive swap outsfor GE installations? You talked about seeing some of those in the past.
Sure, as you might guess, the installed base of oldercompetitive products are now coming to term on lease, or otherwise and many ofthose are now, are being approached by Hologic sales folks in terms ofreplacing those with new Hologic equipment. We are succeeding in winning oversome of those accounts. Tycho Peterson - JP Morgan: On the topic of bundling, you have talked in the past aboutthe pull through with maybe Suros in some of the multi-care tables. Can yougive us a sense as to how often you are seeing bundling as well?
We are first of it, we sell a multi-care table, we arealways quoting on [a-tech] as well, so that there is an automatic synergisticfit between the multi-care and our breast biopsy products. In addition,although there's not a direct link, there's a packaging and pricing, when wesell Selenias, and as that relates to an a-tech, or a multi-care for thatmatter even, our osteoporosis assessment products. I would say that at thispoint, that bundling equates to somewhere near 20% to 25% of our business,incorporates a Selenia with other modality type products. Tycho Peterson - JP Morgan: It's okay. You have been pretty good in the past aboutbreaking out Suros R2, and the AEG contribution. Is that something you can doagain and maybe add BioLucent?
While the R2 is a little bit difficult, it's all bundledtogether in the $101 million of Selenia sales. For the most part, most of theR2 we sell is bundled on digital. There's still some small follow-on analog,but it really is together. It has become just a normal part of Selenia at thispoint. Over 90% of the US Selenias had CAD on it. Suros has been steadily increasing every single quarter. Ithink this past quarter, we hit close to $18 million on the Suros. I mean theimportance there is if we look out into FY '08, we are continuing to see thatto increase, now that we have more of the boxes out there. And we are guidingto a $30 million increase in FY '08 over the almost $60 million that Suroscontributed in FY '07. So it's nice growth in FY '08 for that whole Surosgroup. Tycho Peterson - JPMorgan: Okay. And then finally, I guess if I'd be somewhat remiss ifI didn't give you a chance to address the Philips news, so however you want tocomment on that.
Well, this is Jack. I don't really see it as a lot of news,but I think that we have a high regard for Philips. We know them very well.They have no experience or very, very limited experience in sellingmammography. They did years and years ago, and they actually sold an old Loradprivate label product. They sell, and they have access to a Siemens system in Europeon the analog side. If it's a new system, then they will have to go through thePMA process. If it is a system that they're using from someone else under aprivate label, they will still have to do some filings. The only ones that areapproved, as you know, are Siemens, ourselves and General Electric and Fuji. So I don't know where they're going to go for it unless it'swith Siemens. If it's with anybody else, they'll have to go through theprocess. I think they're a great company, and I think they should stick totheir knitting on 64-slice CT scanners and MRIs. Tycho Peterson - JP Morgan: Okay. That's helpful. Thank you very much.
We'll go next Ed Shenkan, Needham & Company. Ed Shenkan - Needham & Company: Thanks, Jack. A question on the imagers, you know, Quest isgoing to now start implementing. I wondered if you could tell us: how many unitsyou’re expecting for Quest? Maybe what timeframe? And then: how many imagers wedid in the quarter?
We'll I'm going to take a chapter from Pat, because I knowhe has said this so many times. I'm not trying to steal his thunder, but as faras the relationship with Quest goes, over time, we expect to place the imagerin the majority of Quest sites. And that’s about as good as we are going to getrelative to the relationship and the number et cetera. And that is based on ouragreement with Quest, and it's a growing relationship and it's a solid one. And I am very happy we can be involved in that now with Pat,but we are in deference to our client Quest. We are saying exactly what theywould like us to say, and there is no reason for either one of us to kind ofsay any more than we are very, very, excited about the fact that in themajority of their sites, there will be an imager over the course of time. Ed Shenkan - Needham & Company: And can you say: how many imagers were there in the quarter?
Pat, you want to talk about that one?
Yes, we continue to ship over 30 imagers on a quarterlybasis. This quarter, we did 36 for the quarter. And as I have said many times,we expect that number to continue at about 30 per quarter, but we did a littlebit better this quarter than we had historically done in the past. And as to Jack's point, we are very excited that the pilotwas successfully concluded, and they're implementing this phase deployment. Weare very excited about that development. Ed Shenkan - Needham & Company: And now you won't be breaking out internationally, move forwardinto the other business units as you said? Where does GliaSite set? And are youstill thinking about selling that business or is it sticking with the family?
GliaSite will be sold. Ed Shenkan - Needham & Company: Okay. And until it gets sold, where do you break it out?
The number is so nominal that it is really not material atall. It's lost in the, I guess, the surgical number, Pat or --?
Yes, it's in surgical, but it's a de minimus number, notreally material to the results. Ed Shenkan - Needham & Company: And last question, as far as headcount reductions and costsavings with the merger: can you tell us what has happened to date and what youwould expect to happen in the upcoming days?
Pat, you or I could answer that.
Yes, I would say, as I mentioned in my comments, there werea number of senior executives at Cytyc that decided to move on and do otherthings. Tim Adams as an example, Dan Levangie has retired and remains on theBoard, and there were several others. But I think in total, Jack, there werewhat, 10 or 11?
11 people total. Those that decided to leave on their ownand the few others, I mean those changes have been made and everybody is inplace marching forward. So we do not expect to make any changes other than inthe course of normal business. Ed Shenkan - Needham & Company: Then you wouldn't expect changes then in the sales force andother areas? Coming up, should we expect: business as usual?
Absolutely. If anything, I think you would see us addingsalespeople. Businesses are growing, and we are continuing to look in thatarea. But you are not going to certainly see change out there. Those peoplethat were driving the change on the diagnostics and surgical business areexactly the same people in the field that are driving it today as are thedistrict managers and the field salespeople. So we don't see change other thanin the course of normal business. Ed Shenkan - Needham & Company: Thanks, Jack.
We will go next to Mark Richter, Jefferies. Mark Richter -Jefferies: Hi, guys. Good morning.
Good morning, Mark. Mark Richter -Jefferies: Can you just break down new orders in the quarter? They wereobviously strong US versus OUS?
For which product line? Mark Richter -Jefferies: For: digital mammography systems.
Usually, it runs 80-20, but, Rob?
It looks like we, of the orders that we booked -- I am justlooking at some of the information we have. I think it's…
350 so on units were domestic, and the balance isinternational for the booking rate for the quarter. Mark Richter -Jefferies: Okay. Perfect. Thank you. And during the quarter, RadNet obviouslyannounced it will purchase over 30 full-field digital mammography systems.Based on our diligence, we learned that that was you guys and also learned thatthey have about 55 or so sites that could buy additional digital systems. Canyou just comment on: if you have any expectations of filling those orders and sortof timing on that?
Well, at this point, we are focusing on the initial orders,and obviously we want to do the best job that we possibly can on those. And Iam sure if we execute, then there will be future business that hopefully we willbe rewarded with. Mark Richter -Jefferies: Okay. Thanks. And then back to guidance, I mean lastquarter, you talked about sort of with the credit markets declining, peoplewere starting to think about it and talk about potentially this impacting you.You commented that you didn't think it would necessarily impact guidance.Clearly, it did. I mean, Glenn: can you maybe help us understand better what'schanged in that timeframe?
Well, I think when we think about guidance, Mark, I think weare really talking about the effect of the interest expense. Is that what youare asking? Mark Richter -Jefferies: Exactly.
Yes, because the $0.05 effect from Cytyc closing three weekslater than we anticipated is clearly unfortunate. We just can't get around thatin purchase accounting. You don't get credit for those three weeks. So that'sjust the way it is. I think when we look at the interest expense, I mean, thereare some uncontrollable factors here. And as the credit markets weakened -- Imean, we appreciated we are in a very strong position with the syndicate ofbanks that provided a firm underwritten loan. We knew this deal was going toget done, but at the same time, we wanted to play it very efficiently. We did, in fact, make some certain accommodations duringthis timeframe. And as you know, we really didn't have much control over LIBOR.So when we take all of this into account, it did have an impact. I would arguethat in my mind, it isn't any kind of sizable impact, because if I am sittinghere a year from now and most of that term loan is gone, we are going to be ina much different position. So I am not troubled by that $0.15. I mean, it's very shortlived in any case. And I think we just have to appreciate it for what it was inthe kind of credit market environment we have. Mark Richter -Jefferies: Okay. Thanks. That's helpful. And the last question just is:can you provide us to the extent that you're comfortable, or will any tomosynthesisupdates, in terms of timing of anything, basically: any timeline updates ontomo?
Sure. The FDA submission has been completed. We are waitingfor comments and obviously a review. There will be a panel review. It is notyet scheduled. Other than that, we believe that we are on track from productdevelopment perspective and are also in a position, come the first calendarquarter, we'll be installing baby units at clinical sites, so that we cangather more market data. We will be presenting some additional clinical data at RSNAas well in terms of the findings from our reader study and the researchers thatwe have used thus far. That's about it.
As an add on that, the market data that Rob is talking aboutthat we'll be doing in the January, March timeframe has nothing to do with ourfiling. It is additional work that we're doing, and the filing what's completeand submitted as he said. This is for other indications and uses. Mark Richter -Jefferies: Perfect. Thanks, guys.
We will go next to Amit Bhalla, Citi. Amit Bhalla - Citi: Hi. Thanks for taking the question. I just wanted to followup there on tomosynthesis. So what's the date that you are expecting for thepanel?
We don't really have a specific date yet. That is stillunder discussions. We would imagine that it's probably sometime in the firstcalendar quarter. Amit Bhalla - Citi: Okay. And then for Glenn: can you talk to us about thesynergy guidance and any updates there on the cost and revenue side for thenext couple of years?
Yes. When we pulled our budgets together, we didn't reallyfocus on the synergies as much as we focused on the growth going forward. So Ireally don't have a good update to give you, nor do I anticipate going forwardthat we will step back and look at any kind of synergies. I mean we are goingto look at this going forward, but I would -- this is high-end supply a littlebit with some of the cost savings we talked about earlier. We are clearly in a growth mode. And if we look at therevenue guidance for FY '08, for the full year for Cytyc, we're looking atprojected revenue of 20%. So it really is all hands on Board to get that growthhere, both domestically and to expand internationally. So the synergies are the simple synergies that you wouldexpect by cross-selling with sales forces that we've talked about before, but Ithink that we don't have a dollar amount to put against it, some of the costsavings from one public company, but they're clearly not anything substantialreally to go into. This is all about driving both companies' business goingforward. Amit Bhalla - Citi: Okay. That's helpful. Can you comment on the mammographyoperating margin? It again was very strong in the quarter. Can you talk aboutwhat your expectations are for 2008 and what kind of room you kind of left foryourself for better contribution on the bottom-line?
I think as we continue to grow that business, we have twothings that work in our favor. One is that obviously we are getting betterfactory absorption and utilization. So we have just an implicit marginimprovement from that perspective. And then secondly, our operating expensesare not all variable. So, again, as we continue to shift more, we end up havingimproved profitability because of the fixed versus variable aspects ofoperating expenses also benefited by the gross margin improvement that Imentioned just a bit ago. Amit Bhalla - Citi: So: what should we be thinking about for the mammographyoperating margin for next year? And I'll just throw in: how should we thinkabout the order run rate for the upcoming quarters?
I will answer the second one first. As we have always said,orders are not, they're not a trend in a quarterly snapshot because of thingsjust like this last quarter. That's an extraordinary example. But there maybeothers where there are larger orders from single customers that end updistorting what the trended orders might look like within a given quarter. We're expecting order growth. We're expecting, both growthin the domestic market and also we're expecting very strong growthinternationally for this upcoming year. As far as the operating margins, froman improvement perspective, I think we have commented on our gross margins froman overall business perspective. I think where we are going to see operating marginimprovement is on really just the reduction in operating expenses as apercentage of sales for the very reasons that I gave earlier in terms of thatbeing fixed versus variable. And we assume that maybe that's 1 to 2 percentagepoints of an improvement relative to operating expenses as a percent of thatbusiness unit's revenue. Amit Bhalla - Citi: Okay. So then, I just want to make sure I heard itcorrectly. You did about 1,320 orders this year for fiscal '08. That ordernumber should be increasing on a full year basis?
Yes. Amit Bhalla - Citi: Okay. All right. Thank you.
We will go next to Isaac Ro, Leerink Swann. Isaac Ro - LeerinkSwann: Good morning, everyone. Thanks for taking the question.First question, could you maybe give us an update on where you stand in termsof your space and maybe capacity in Costa Ricaand what your plans are for that space over the next year?
Yes, we are in the process of building a new factory in Costa Rica. We've got about one of the factoryright now of about 40,000 square feet. We're on a two-shift basis there in thecurrent facility. We have broken ground. The shell is up. We expect thatfactory to come on line mid next year, and it triples, more than triples thefootprint of the factory that gives us more capacity to meet the demand. Isaac Ro - LeerinkSwann: Okay.
It's also for expansion purposes of other capacity that wehave in place for those type of assembly products. Isaac Ro - LeerinkSwann: Okay. Thanks. And then second question would be on theosteoporosis business. It looks like the operating margin there has stabilized.What do you think the opportunity is a year from now in that business based onthe current reimbursement environment?
I think we are seeing a shift. First off, let me commentthat I think our international business has been quite strong. So, we see goodmargin and revenue, certainly not double-digit growth, but a stable to moderategrowth business. Domestically, I think we've seen the worst of it relative toa decline in revenue, and that was primarily the result of our focus on primarycare, which is a market, which is much more difficult than a decliningreimbursement environment to penetrate. What we are seeing today is acute care of a hospital marketresurging relative to not just more units, but at a higher ASP, because theytypically are higher end product offerings. So, again, it's not going to be adouble-digit growth business for '08, but we do believe that a single-digitgrowth in that 5% to 6% range is appropriate for that business. Isaac Ro - LeerinkSwann: Okay. Great. And then last question would just be on CAD. Iknow in the news lately, there has been a little concern coming out of, Ithink, United on reimbursement changes there. Given what happened over in Portlandearlier this year, do you think it's conceivable that UNH has taken a similarkind of very limited cursory overview of that New England Journal study andreally haven't kicked the tires on the benefits of the technology and thatmaybe there is a more in-depth policy review that's going on there?
Yes, to all of that. We think that it's a reaction to anarticle and a study that have known flaws. Clearly, much effort is going intoconvincing United that that was a decision -- they erred in their decision. Ourexpectation is that they will see the benefits clinically of CAD and will dothe right thing for their universal patients. Isaac Ro - LeerinkSwann: Great. Thanks so much.
We will go next to Jayson Bedford, Raymond James. Jayson Bedford -Raymond James: Hi. Good morning. Thanks for taking the call. Just a coupleof questions: First, because I know it's going to come up, just looking at thenumber of Selenias in the quarter, your guidance was 340. You didn't expect the40 unit order. You did 351. You backed that out. You did 311. I am justwondering: is that more of a timing issue? And is the more important number:the number of new orders at 403 units?
Well, the units that came in, none of those were revenue forthe quarter. Jayson Bedford -Raymond James: Okay.
And that's the first thing. And then secondly, in fact,those will not materialize as revenue. All, within even this next quarter,those will be spread out over multiple quarters. Jayson Bedford -Raymond James: Okay. So they're part of the new order number.
They're part of the new order number. Yes. Jayson Bedford -Raymond James: Okay. Thanks. That's helpful. And then on the guidance, Ithink I have somewhere in my notes that combined business gross margin could be65%. It looks like the guidance here is 61% to 62%. One: did I hearincorrectly? Or two: what has happened in the last few months?
I don't think anything has happened, Jayson. As we put thebusinesses together, we really focused on where we would add for FY '08 and tryto structure our guidance around what we are seeing today. I think what we haveto appreciate is just like in the Hologic businesses where we always talkedabout a target margin of getting to of 50%, that's what the 65% represents. Wehave a target out there that we are going to strive to hit over the next yearor two, and that would be that 65% target. And it is being driven by the someof the things Rob talked about. I mean: clearly, the mammography/breast care segment has thehighest potential for improved gross margins. I think the surgical would beprobably number two, led by NovaSure. So, we see a path getting up to 65%. Weare not comfortable for FY '08 at being there at this point in time, but that'swould be the direction we'd expect to head as the revenues continue to increaseand we get more leverage out of the business. Jayson Bedford -Raymond James: Okay. That's fair. And then lastly, just a couple of quickones for Rob on the mammography side: Are you selling more or seeing increasedinterest in the Selenia S product? And then secondly: are you seeing moreinterest from lower volume centers out there?
There is a pick up in Selenia S, but it's still a smallpercentage of the number of overall Selenias that get booked. To the secondquestion, yes, we are certainly now seeing that it's a combination, as I said,of multi-system orders with larger customers, but it's also smaller customersnow that are looking at Selenia, but they're looking at it from a group buyingperspective. So, they're a member within a GPO, and they're relying onthe GPO to negotiate better rates or better pricing for them. Groups likeBroadlane or Novation. So although they maybe smaller players with not a lot ofbuying power, they're benefiting by the buying power of being a member oforganization. So we are seeing a lot of tie-ins to that as well. Jayson Bedford -Raymond James: Okay. And then just lastly, Rob, just on the tomosynthesisproduct: have you completed the final form factor of the product?
Yes. There are alpha units that are in a commercial format,but built under engineering control that are in the market today at two sites,two research sites. The beta units will be built under manufacturing controlpre-FDA, and those will be out in the market in January. But they're aduplicate or really ostensibly the same product as our alpha just built by adifferent discipline within the organization, meaning manufacturing versusengineering. Jayson Bedford -Raymond James: And the manufacturing and scale-up preparation for the betaunits: is that largely complete?
We actually already have the infrastructure built in oursecond facility in Danbury, Connecticut.So, the alphas were built by engineering with manufacturing support. The betaswill be built by manufacturing with engineering support, all within the samefacility, which has already been created. It's part of the organization that wehave in Connecticut. Jayson Bedford -Raymond James: Okay. Fair enough. Thanks, guys.
We will go next to Thomas Kahn, Kahn Brothers. Thomas Kahn - KahnBrothers: Good morning. Could you tell us again when will thetomosynthesis be in the market? And secondly: when will the Selenia machines beshipped with the mechanism for tomosynthesis built in? Whether or not thecustomer is going to buy tomo at this time or not?
In terms of when the product will be released, a commercialrelease will really be contingent on FDA approval. So if we assume sometime inthe second calendar quarter, but again, it's contingent on FDA approval andthat may be unknown at this point. Thomas Kahn - KahnBrothers: Okay.
With respect to the product shipping with the capabilitiesof tomo, the existing Selenia will not. The new platform product and for lackof another name, will be called, let's call it Selenia 2, will be shipped,leaves the factory as tomo-ready. And everyone of those that will leave thefactory will have all of the mechanisms in it to perform 3D mammography, but itwill be shipped as a premium 2D product. The expectations for '08, however, will be that we will shipthose in very limited quantity. We certainly want to focus on the quality andreliability of the system. And I have told the outside world earlier thatreally we believe that volume for this product should be expected in '09 andbeyond. And in '08 will be a year of hardening the designs from a commercialperspective and improving upon its performance. Thomas Kahn - KahnBrothers: What happens in '08, let's say, that Selenia and Selenia 2 areavailable? How do I make a choice as to which I want to buy? And, if I buy theSelenia, how do I get a credit or upgrade if I then want to go to Selenia 2?
You have almost answered the question for yourself, which isvery good. And that is that if you are -- Selenia 2 is going be sold at apremium. People that buy it in '08 will be buy it because they want tomo.They're early adopters in academic environment. They're willing to pay thepremium. They're going to buy a Selenia, and they don't need 3Dmammography. They'll buy the standard Selenia today with the idea that they'llget a trade-up credit to be applied to their tomosynthesis product when and ifthey're ready. That trade-up credit is yet to be determined, but we have alwayshad a history of obsolescence protection as a company and are most fairrelative to the amount of trading credit and the amortization of the value ofthat unit over time. Thomas Kahn - KahnBrothers: Now: would anyone buy a Selenia 2 without the software to dotomo?
Sure. You can buy a --. Thomas Kahn - KahnBrothers: How would they do that, Rob? In other words, why would I buya 2 -- I mean, in other words: I wouldn't have the money in my budget to payfor the software: so I buy the 2 with a hope that I get the money later on tobuy the software?
That's exactly right. So you would buy this premium 2D thatleft the factory tomo-ready. Thomas Kahn - KahnBrothers: Yes.
With that idea that in next year's budget, you got thesoftware key or license to then do 3D mammography. Thomas Kahn - KahnBrothers: And do we have a rough idea as to what a Selenia would cost?Or the Selenia 2 would cost? And then the software would cost?
Well, the Selenia 2 is going to be a premium over theexisting Selenia, because in fact it is tomo-ready and has other features andfunctionality benefits to it. The premium for tomo, as a standalone upgrade, isprobably somewhere in the area -- and the markets will take their time, butwill be somewhere in the area of $150,000 to $200,000. Thomas Kahn - KahnBrothers: So, what we are saying, basically, is kind of with the samenumber of units, your revenues could be very much elevated, because while theymay be a Selenia unit, they're really a Selenia tomo unit, which goes for muchmore money?
I think with the addition of tomo shipping at volume, ofcourse, the ASP will change on the product because of the added value of 3Dmammography. In addition, a significant component of that will be software. Sothe expectation would be that the… Thomas Kahn - KahnBrothers: And margins.
The margin on the product would be better as well. Thomas Kahn - KahnBrothers: Great. Thank you very much.
We will go next to Bruce Jackson, RBC Capital Markets. Bruce Jackson - RBCCapital Markets: Hi. Good morning. A couple of Cytyc questions. Can you tellus how many disposable units were sold in the quarter and what percent wereimaged?
Sure. It was greater than 50% of the test in the quarterwere run through the ThinPrep Imaging System. We did see a little softness inour ThinPrep Pap Test kit number two, just a little over 8.5 million tests, whichwas driven primarily by ordering patterns of our largest customers moving to adistant time procurement. Now, we are currently back at the run rate of the 9 milliontests per quarter on a quarterly basis. And again, 36 imagining systems wereshipped during the quarter. Bruce Jackson - RBCCapital Markets: Okay. And then with the imaging revenue, was it about $20.4million?
Yes. It was just north of that, Bruce. Bruce Jackson - RBCCapital Markets: And then, okay. And then do you also -- can you give us thebreak out on the Adeza revenue for the quarter?
Yes, Adeza actually had a very strong quarter. They were up19% over a year ago, pre-acquisition 11%. In the second quarter, they were over$15.5 million in revenue, which was a very strong quarter for us. And I thinktwo reasons for that. One, I think the sales force is now fully trained withthe initial training on the symptomatic patients. And we also, in calendar Q3,began training our sales team on the value of using the full-term tests for theat-risk population. So, we're feeling pretty good about the traction we have onfull-term. Bruce Jackson - RBCCapital Markets: Do you have an estimate for: how much of the at-riskpopulation we are getting?
It's a very difficult number to try to back into at thispoint. Bruce Jackson - RBCCapital Markets: Okay. How about NovaSure? What was NovaSure in the quarter?
Overall, NovaSure for the quarter was about a little over$56 million in quarterly revenue, up 25%. It was down a little bit from ourcalendar Q2, again, primarily due to seasonality that we typically see in theSeptember quarter, as well as our calendar Q2 was a very strong quarter overQ1, a $6 million increase. We've placed more than 500 NovaSure controllers in thequarter, and if we talk about in-office use, NovaSure was about 9.1% ofNovaSure revenues, up from 8% in the prior quarter and toward our goal of 10%by the end of December. Bruce Jackson - RBCCapital Markets: Okay. And then moving over to United Health and the CADdebate, do you think there is going to be any impact to your 3D tomo discussionwith them because of the increased emphasis on looking at CAD reimbursement?
You mean specifically with United as it relates to tomo? Bruce Jackson - RBCCapital Markets: Just in general. Do you think the reimbursement climate isgetting more challenging, and do you think this could impact your ability toget reimbursed for the 3D tomo?
I think, yes. The reimbursement climate is more challenging.Two, I think however that payer groups and the government are most open andinterested in those technologies that save downstream healthcare dollars. Andas a result, we believe that things like 3D mammography that will have a highersensitivity and a better specificity will find cancers earlier or rule out thepresence of cancer and allow women to exit the healthcare system without havingto go through a diagnostic protocol, all of which will save much more significantdownstream dollars. And therefore, we believe we've garnered the interest andsupport of the payer groups. Bruce Jackson - RBCCapital Markets: All right. Thank you.
We will go next to Junaid Husain, Soleil Securities. Junaid Husain - SoleilSecurities: Hi. Good morning, guys.
Good morning. Junaid Husain -Soleil Securities: Rob, the GE talked about the busy summer with theintroduction of the mobile sonograph essentials. So a couple of questions here:First, what's your take on a mobile digital mammo box? Is it something thatyour customers have been timing for or would you relegate this into the nicheproduct, niche market status? Something maybe more geared for the lower volumehospitals or the rural hospitals?
Let me first comment that we received FDA approval of amobile Selenia two years ago, and we have about 25 units in the market, bothdomestic and international for mobile Selenias, or those which are in coachesor trailers. We think that it’s little bit of a niche. In it, it allows a majorcenter to be able to reach out to some rural communities in different parts ofeastern Washington state, forinstance, or rural Georgia,parts of the Midwest where there is not adequatecoverage. There is not a strong need, but I think there is a benefit being ableto mobilize digital mammography. So, we think that it's certainly helpful andthat we see some activity in it, but it doesn't appear to be changing anyone'slife. Junaid Husain -Soleil Securities: Okay. No, that’s helpful. And then, Pat: if you could, helpus think about the NovaSure business? Especially relative to how much more therunway there is in expanding the market? My model gets me close to 50% of allendometrial ablations performed in the USusing the NovaSure. As you think about this business over the next, call it, oneto two years: how much more can you grow this business in the USand then where are we in terms of expanding utilization of NovaSure in theinternational markets?
I think as you have heard me talk many times about theopportunity for NovaSure, 7 million women are affected in the United States,2.5 million of those seek treatment. We continue to see procedure growth in the50,000 to 60,000 procedures on an annual basis. And I think one of the thingsthat happened during the quarter was that some practice guidelines from theACOG, the American Collegeof Obstetrics and Gynecology, is really helping to expand the use of ablationas the first-line therapy for women with excessive bleeding. Now, this practice bulletin basically says that NovaSure orendometrial ablation is indicated for the treatment of women who have aperceived, heavy menstrual period, and it is not -- and using some other oralcontraceptives or other methodologies to try to solve the problem first shouldnot be construed as a prerequisite. So, our sales force is actively using these practiceguidelines from ACOG that I think is really helping to move the needle inmoving NovaSure up in the front line part of the business rather than going tohormone therapy first. On the international side, we’ve seen tremendous growth incertain areas of the international market, although it's only a relativelysmall percentage of NovaSure sales. UKis very strong for NovaSure, as well as Canadaand the Benelux. So, I think we've got of lot of runwayyet to go with NovaSure. Junaid Husain -Soleil Securities: Great. Thanks, Pat. And then last question for either Jackor Rob. The RSNA meeting is just a few weeks away. Is there anything that weshould be paying attention to in the abstract? Something from the academiccommunity that should be top of mind as we go from scientific session toscientific session at the meeting?
Yes, this is Jay Stein. There is going to be a presentation,I think it is on Tuesday, by Elizabeth Rafferty at MGH in a special topicssession, a hot topics session where she will be presenting some of the clinicalresults from our FDA study. And I think you will find that of interest. Junaid Husain -Soleil Securities: Great. Thanks, Jay. Thanks so much, guys. That's all I havegot.
We will go next to Andy Schopick, Nutmeg Securities. Andy Schopick -Nutmeg Securities: Thank you, and good morning. Glenn, I want to ask you a CFOtype question, trying to absorb all that's being communicated today, especiallyon the numbers side. If I understand correctly, and I really would like to justask you to explain from a financial point of view, the rationale behind it, fornon-GAAP purposes, you are going to exclude amortization of intangible assetsof approximately $140 million for fiscal year '08, but will include, fornon-GAAP purposes, the stock-based comp, FAS 123R. Was it $15 million that wasestimated for this year?
That's correct, Andy. The stock-based comp we are expectingright now is $15 million for FY '08. Andy Schopick -Nutmeg Securities: I'm sorry. Repeat that.
$15 million for FY '08. Andy Schopick -Nutmeg Securities: As you are probably aware, there are some companies thathave begun to now not include these FAS 123R expenses going forward fornon-GAAP purposes, but others are continuing to do so. I guess I want to askyou, as the Chief Financial Officer: what is your rationale now for no longerbacking out these FAS 123R expenses for non-GAAP reporting purposes?
Well, we are thinking about it in a more simplistic way,Andy. And that is, if we think about the biggest adjustment to our GAAPnumbers, it is the amortization of intangibles. It's a huge number. It's a bignumber. It's directly related to the merger with Cytyc. Andy Schopick -Nutmeg Securities: Of course.
And when we talked in May, we had always excluded onenumber, and we really focused on one number to keep it at that simple level.And that's why I continue to talk on a non-GAAP adjusted basis of justexcluding the amortization of intangibles. Although at the same time, even though I say that, we putout a press release and we clearly identify on the front page of the pressrelease what the stock option expense is, so that those individuals thatcontinue to like to back that out, have that information available. And on ournon-GAAP reconciliation to GAAP on the back of the press release, I do includethat FAS 123R charge. So even though I really harped on this in the conferencecall, what we do is throw those out, Andy, and let everybody make up their ownmind on how they would like to treat it. Andy Schopick -Nutmeg Securities: Is there a reason why you feel it should no longer be, theFAS 123R, treated as a non-GAAP measure?
I just simply think that the amount itself is becoming smallenough that it doesn't have the same kind of relevance that might have in thepast, and it is clearly overshadowed by the amortization of intangibles. Andy Schopick -Nutmeg Securities: Okay. Thank you.
And we will have a follow-up from Amit Bhalla, Citi. Amit Bhalla - Citi: Hi. Thanks for taking the follow-up. There were somequestions earlier about new entrants into the market. And I remember about ayear ago, the FDA panel met to lower the hurdle for new entrants from a PMA toa 510K. Can you talk to us about where that stands with the FDA? Obviously, itseem like it's been delayed in terms of implementation.
It has been delayed. Our expectation is, is that it will gothrough sometime by late 2008. There, again, it will be, we believe at least, abit late since the market will be looking at new technologies like 3Dmammography and the like. And to come to this market without an install basewith 2D mammography and not an upgrade path to 3D probably doesn't give us asense that they will have a lot of traction. But in any event, we do believethat the downgrade will occur, and it will probably occur by the end of '08. Amit Bhalla - Citi: So that means: competitive pressures in the near term arepretty de minimus?
The competitive pressures are what they have been, which isostensibly, we compete against GE, Siemens and to a lesser extent, Fuji. Amit Bhalla - Citi: Right. Okay. Thank you.
And we have no further questions in the queue. I'll turn theconference back over to Mr. Cummings for additional or closing remarks.
Well, thank you very much. I'll make this very simple. Wehave, we will be with you again in December -- excuse me, in November at theRSNA. Once again, we welcome you and invite you to join us there. You can go through the IR office and Franc Crecco here, andshe can be able to help schedule that for you. Secondly, we have our holidayscoming up, so we want to wish everyone a very safe and happy holiday and peacein the world. And with that, we will see you again at the end of thecalendar year and report to you on our first quarter results. We thankeverybody. And again, welcome to all of our Cytyc friends throughout the worldwho have now joined Hologic. We're going to do great things together. And Pat,thank you so much for joining us and your comments today, and we look forward tokeeping your streak alive. Thank you, everybody.
That concludes today's conference. You may disconnect atthis time.