Earnings Labs

Hologic, Inc. (HOLX)

Q4 2005 Earnings Call· Mon, Feb 20, 2006

$76.01

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Transcript

Operator

Operator

Good afternoon, I would like to thank all participants for holding. All lines will be on listen-only until the Question and Answer portion of today's conference, and I would also like to inform all participants today call is being recorded. If you do have objections you may disconnect at this. Right now I would turn the call over to Mr. Michael Watts, thank you sir, you may begin.

Michael Watts, Senior Director Of Investor Relation

Management

Thank you Brian, and good afternoon everyone, this is Michael Watts, I am a Senior Director Of Investor Relation and Corporate Communications. I am pleased to welcome you to this conference call to discuss our Fourth Quarter 2005 Financial Result. Press release announcing our result was issued today, if you haven't seen it, its posted on our website at www.genprobe.com. In our call today, Henk Nordhoff, our CEO, will first provide an overview of our accomplishments in the fourth quarter and some of our priorities for 2006. And Herm Rosenman our CFO, will review fourth quarter financial results and 2006 guidance, we will then take your questions. Before we begin, let me first review our Safe Harbor policy. Forward-looking guidance financial or otherwise is only provided on conference calls or in our press releases. Any statements in this conference call about our expectations, beliefs, plans, objectives, assumptions or future events or performance, are not historical facts and are forward-looking statements. These statements are often but not always made by the use of words or phrases such as believe, will, expect, anticipate, estimate, intend, plan and would. For example, statements concerning 2006 financial guidance, financial conditions, regulatory approvals, and timelines, possible or assumed future results of our operations, growth opportunities, industry ranking, and plans, and objectives of management are all forward-looking statements. Forward-looking statements are not guarantees of performance. They involve known and unknown risks, and uncertainties that may cause actual results to differ materially from those expressed or implied. Factors that might cause such differences include, but not are not limited to, those discussed in our SEC filings, including our report on Form 10-K for the year ended December 31st, 2004, and all subsequent periodic reports. Copies are available on our website at www.sec.gov and on request from our Investor Relations department. Gen-Probe assumed no obligation and expressly disclaims any duty to update any forward-looking statements to reflect events or circumstances after the day of this call or to reflect the currents of unanticipated events. With that administrative detail as a layout, I will turn the call over to Henk Nordhoff, Gen-Probe's CEO.

Henry Nordhoff, Chief Executive Officer

Management

Thank you Mike, and good afternoon everyone. As described in our press release our fourth quarter results caped off another strong year for Gen-Probe. We showed impressive top and bottomline growth while making important progress for advancing key short, medium and long-term growth drivers. We have a lot to cover in our prepared remarks so, let me jump right in. I planned to discussed three areas today. First, I’ll provide a high level overview of our record fourth quarter financial results. Second, I give you an update on the regulatory strategy for our near-term growth drivers in blood screening. And third, I’ll help you understand, why we are so excited about the future by highlighting some exciting work taking place on our prostate cancer and industrial initiatives. Let's begin with the fourth quarter results. Product sales were $78 million in the quarter, a new all-time high and 33% higher than last year. This extends an impressive track record of consistent organic growth of the 14 quarters since our spin off, this is the 13th time we have achieved a new sequential record in product sales. This strong growth and products sales help drive total revenues in the fourth quarter up 28% versus last year to $88 million, and earning per share up 39% to $0.32. Our fourth quarter results demonstrate that the fundamentals of both our current key business: clinical diagnostics and blood screening are strong and vibrant. Clinical diagnostic sales total $37.3 million in the fourth quarter of 2005, up 14% compared to the prior year period. As in the last several quarters, clinical diagnostic sales benefited from market share gains of APTIMA COMBO 2, our amplified assay that simultaneously detects Chlamydia and Gonorrhea. We believe APTIMA continues to solidify its position as the best-in-class STD test, particularly when…

Herm Rosenman, Chief Financial Officer

Management

Thank you, Hank and good afternoon everyone. As described in our press release Gen-Probe had a strong fourth quarter. Products sales grew impressively over the same period in 2004 and also increased on a sequential basis establishing another quarterly record. Total revenues also hit an all-time high and earnings per share exceeded expectations as well. Hank already covered the dynamics of product sales, but let me reiterate that blood-screening sales benefited from approximately $3.6 million of previously differed revenue. We told you to expect this revenue last quarter, but the actual amount was higher than we anticipated, a simply on the rate at which US inventory was transferred out of the Chiron Virtual Warehouse. This benefits our topline more than our bottomline however, since we record the revenue at a contractual transfer price that includes little margin. Now let me turn to collaborative research revenues, which were $6.5 million for the fourth quarter of 2005, a decrease of 18% compared to the prior year period. This decrease was expected and resulted primarily from low reimbursement from Chiron who shared blood screening development projects. Royalty and license revenues were $3.5 million in the fourth quarter, up 59% from the prior period. As anticipated, this increase resulted from BioMerieux exercising their option to pursue additional diseases targets using our patented Ribosomal RNA technologies. BioMerieux next option is in the fourth quarter of this year, which we expect to be our next opportunity for revenue recognition under this agreement. Gross margin on product sales was 66% in the fourth quarter of 2005, compared to 70% in the prior year period. The gross margin percentage was reduced by the virtual warehouse liquidation and more importantly by the sale of $2 million of TIGRIS instruments to Chiron at cost was $2.1 million of spare parts…

Michael Watts, Senior Director Of Investor Relation

Management

Thanks Herm, we are very happy to take your questions now, for Q&A we are join by Larry Mimms, Executive Vice President of R&D; Bill Bowen, Vice President, and General Counsel; Glen Freiberg, Vice President for Regulatory Quality And Government Affairs; Steve Kondor, Vice President, Sales and Marketing; and Lynda Merrill, Vice President of Industrial Relationships. In order to ensure broad participation in the Q&A session, please limit your questions to one but the follow-up then, please jump back into the queue. Operator, we are ready to take the first question.

Operator

Operator

Operator Instructions

Management

Q - Bill Quirk

Management

RBC Capital Markets. Was the risk of, incurring you are at, Herm on then I go with Chiron question. Is Chiron currently negotiating with West Nile customers presumably you have the eSAS but what about those of TIGRIS, I assume that they are talking about that?

A - Henry Nordhoff

Management

Bill, Herm is in rages over here. He asked me to take the question, as you know, very many of the West Nile customers have the TIGRIS instrument. So, as far as we know, Chiron is talking to all the West Nile Virus customers.

Q - Bill Quirk

Management

Understood and so, if we think about the ultimate approval of West Nile and TIGRIS, should we be thinking about a similar delay in terms of customer notification that we are seeing right now with eSAS? Or since the negotiations are basically taking place right now, we're essentially going to be able to in essence kind of, flip to switch, and we should be able to move the commercial pricing soon after the alternative FDA approval for TIGRIS?

A - Henry Nordhoff

Management

That's a little complex and we alluded to that a little bit though in the commentary, there will be a delay, contractual delay when we go to commercial pricing. For those customers that are still under an IND, we will probably rely first on an increase in the cost recovery price. And in some cases, it may very well be that the increase price for cost recovery is in advance of the commercial pricing on the IVD product.

Q - Bill Quirk

Management

So, if we think about the logistics of how pricing is going to move once we get TIGRIS approval for West Nile, we should continue to essentially assume that this delay for customer notification, I can't do what we were experiencing right now with West Nile and eSAS?

A - Henry Nordhoff

Management

I think that's right.

Q - Bill Quirk

Management

Okay.

A - Henry Nordhoff

Management

Again, I think that's right Bill.

Q - Bill Quirk

Management

Thanks very much guys.

A - Henry Nordhoff

Management

You are welcome.

Operator

Operator

Your next question comes from David Lewis, please state your company name.

Q - David Lewis

Management

Thomas Weisel Partners. Good afternoon.

A - Henry Nordhoff

Management

Hi David.

Q - David Lewis

Management

Just a couple of quick ones here. I guess, first of all, you are talking a lot of interesting opportunities in 2007 but sales and marketing was little lower than we would have thought. I guess, maybe, talk us or walk us through your sales or marketing priorities, we are trying to prepare for a launch with Millipore in 2007, PCA3 is, you have started to think about potential programs there. How you are prioritizing given sales and marketing has been drop 9% to 10% of sales?

A - Henry Nordhoff

Management

Steve Kondor, would you reply to this one.

A - Steve Kondor

Management

Yes thank you. David, PCA3 is very important for our future success in oncology and we are prioritizing our efforts accordingly. CTGC our APTIMA business remains solid and PCA3 is important for our future success.

Q - David Lewis

Management

Is it a safe assumption that to make no pro-relationship also would like a PCA3 to what we would like for broader commercialization of '07, the rate of spending has to be increased in 2007 versus '06?

A - Henry Nordhoff

Management

I will let Lynda to answer the similar portion of the question.

A - Steve Kondor

Management

On the PCA3, for sure, is going to increase this year, a lot of that will be in publicizing some trails that we have and I will pass to Lynda the Millipore.

A - Lynda Merrill

Management

With Millipore being our marketing partner, I don't believe we will see a tremendous increase in Gen-Probe's marketing expense for that.

A - Steve Kondor

Management

A lot of the work this year will be, I guess, what we call now an alpha test. We have the specs, putting the specs into our products and then sending that products when probably it’s about half finished according to the way we normally do things. To make sure that we get the early customer input to incorporate that back but the sales and marketing again, that the vast majority of that all will be done by our partner Millipore.

Q - David Lewis

Management

Okay then, Herm for last question. On PACE degradation, can you focus here in terms of some of your larger customers are beginning to upgrade with new equipment with other competitors, is there a reason to believe that, because of that relative shift we should we should see more PACE degradation in '06 than we saw in 2005?

A - Herm Rosenman

Management

Right now.

A - Henry Nordhoff

Management

Steve, are you in a better position to answer that one?

A - Steve Kondor

Management

Excuse me.

A - Henry Nordhoff

Management

Are you in a better position to answer that question?

A - Steve Kondor

Management

I did not hear the question.

A - Henry Nordhoff

Management

Whether we are going to see a greater decline in PACE sales this year compared to last year?

A - Steve Kondor

Management

We expect to see a decline of approximately the same amount, our conversion rate is going to be about 60%. And we, our customers continue to request the amplified assay.

A - Henry Nordhoff

Management

As you can you probably tell, Steve is at our Annual International Sales Meeting, he is not in the same place that we are.

Q - David Lewis

Management

Okay, thank you very much.

A - Henry Nordhoff

Management

David, just to give you the numbers, PACE I believe, for the full year was down about 13% this year, it’s down, fourth quarter of about 16%, we will expect somewhere in that range next year as well for '06 revenue.

Q - David Lewis

Management

Okay, that's actually very helpful.

Operator

Operator

Our next question comes from Bruce Cranna, please state your company name.

Q - Bruce Cranna

Management

Hi good afternoon, it Leerink Swann. Guys, can you remind us, and maybe this is the question for Herm not sure about it, at the back during the beginning of the trials for ULTRIO, a similar call in the percentage of the US blood screening new business was being done on TIGRIS, was somewhere around 10%, is that still a good number?

A - Herm Rosenman

Management

You are talking about, I think, we started trials for ULTRIO

Q - Bruce Cranna

Management

No, the initial problems with ULTRIO and FDA

A - Herm Rosenman

Management

I don't know, that we ever gave a percentage.

Q - Bruce Cranna

Management

Okay, well I am fishing for that, can you give us some sense as to how that volumes breaks out in US?

A - Herm Rosenman

Management

Yeah, Mike you wanted to have the…?

A - Michael Watts

Management

Yeah, firstly, the percentage has increased, and we have alluded to that in the script, our best estimates from our friends at Chiron is around about third of the testing today, for West Nile, is being done at TIGRIS and we were frankly pretty encouraged by that.

Q - Bruce Cranna

Management

Okay.

A - Herm Rosenman

Management

And here is a clarifying comment by Glen Freiberg who is our Regulatory Affairs, VP.

A - Glen Freiberg

Management

I understood the question to be a percentage of ULTRIO and TIGRIS? Is that correct?

Q - Bruce Cranna

Management

No, I was trying to, I was purposing my question by, initially I think, when there were issues with ULTRIOs filing. That's where this question come up initially, how much of you’re the US blood business was being done, screening was being done on TIGRIS versus eSAS, I think to recall it was 10%?

A - Glen Freiberg

Management

No, there was nothing being done at that time, I think, maybe we were referring the kind of the long lead time for ULTRIO, TIGRIS and the fact that, we initially, we expect a lot of ULTRIO testing to be performed on eSAS.

Q - Bruce Cranna

Management

So about a third of the numbers about a third today on TIGRIS?

A - Glen Freiberg

Management

Well for West Nile Virus. Yes.

Q - Bruce Cranna

Management

Okay, did you guys, did you have any shipments, clinical shipments of TIGRIS in the quarter, on the clinical side?

A - Glen Freiberg

Management

We did, Bruce, as you know, we don't do the numbers on the number of TIGRIS instruments, we had in clinical shipments.

Q - Bruce Cranna

Management

Okay, that's sort of the, and then last question on PCA3. Can you perhaps, maybe some one give us a sense as to, what kind of the enrolment numbers that you might be looking to put together in '06? And when, I guess, it’s kind of early but when we might see some data and how many live partners you might have putting that together? Thank you.

A - Henry Nordhoff

Management

I will ask Larry to comment as much as he can because a lot of this is really in discussion right now.

A - Larry Mimms

Management

Our number of pre-clinical studies ongoing with some of the key researches around the country including research in UCLA, University of Washington, John Hopkins and The Anderson so those pre-clinical studies are ongoing. We are in the process of designing the clinical trials, so I can't really give you in, we obviously need some guidance here and in some further discussions with the FDA but, we are in – we do have a number of pre-clinical studies ongoing.

Q - Bruce Cranna

Management

It is such as no kind of rough idea is to, what that might to be number of patients?

A - Larry Mimms

Management

I can't give you that number right now.

Q - Bruce Cranna

Management

Okay.

A - Larry Mimms

Management

It really will depend on the claims that we decide to go after. So I’d like to differ that for another quarter.

Q - Bruce Cranna

Management

Fair enough, thank you.

A - Henry Nordhoff

Management

Thank you Bruce.

Operator

Operator

Our next question comes from Quentin Lai, please state your company name. Q – Quentin Lai: Robert W. Baird. Again going back to the PCA3 question, you’ve mentioned that the new marker that you just acquired along with AMACR and then PCA3 showed initial results of very good detection, does that change at all the pace of how you are going through the ASR to FDA approval cycle for either one or three probes?

A - Henry Nordhoff

Management

Initially that we are going to go on a generational approach, Quentin, the first will PCA3 alone standalone. And then we will do some testing, I think, some of the information we have is based on an incredibly small number of samples and it’s hard to go from that, too much larger one. So, we are in the process of validating all of the four markers that we are looking at both alone and in combination and tried to pause at which ones, when it combine will offer the greatest coverage. Q – Quentin Lai: Thank you, and then any update on your initiatives on HPV testing?

A - Henry Nordhoff

Management

We are moving along fairly rapidly on HPV, we expect to spend a lot of money this year and advancing it both in getting the other goals and then doing the necessary studies. More and more we hear and all of the executives in the company have to spend a certain minimum number of days in the field talking with customers. It’s rare the ones who go on a visit and don't hear a plea from the customers who are currently using the improved HPV assay, then is to Gen-Probe assay going to be out there, in terms of performance and also in terms of convenience on the TIGRIS instruments. So we take that as a very strong player in call to go as quickly as we can with HPV Q – Quentin Lai: Thank you.

A - Henry Nordhoff

Management

Welcome

Operator

Operator

Our next question comes from Tycho Peterson, please state your company name.

Q - Tycho Peterson

Management

J.P. Morgan. Following up on the PCA3 questions a moment ago, are you guys expecting anything at that AUA in terms of publications or anything, pending that we should keep an eye on for the next couple of months?

A - Henry Nordhoff

Management

We will have a couple of presentations at AUA as well as the European Urology Association.

Q - Tycho Peterson

Management

Okay and then regards to the GE collaborations Hank you mentioned but you didn't real give any details of, is anything to update on that front. And also, I guess, you could just comment on, that the level of interest from other industrial markets I know you talked about Food Safety Testing in the past representing us out there?

A - Henry Nordhoff

Management

We had a meeting, and actually a meeting is ongoing today with our colleagues, counterparts, GE that the big thing was agreeing on the specs of the products and the instrument and that’s done very well, we have agreement on that, it’s embedded by both companies and we are moving ahead and that just happened last month.

Q - Tycho Peterson

Management

Now in terms of you know your conversations on other industrial fronts?

A - Henry Nordhoff

Management

We have some conversations ongoing to propel us into the food testing market, they look good but nothing concrete so that I can comment on that right now Tycho.

Q - Tycho Peterson

Management

And then, you guys, talked a little about at your Analyst Day about the unit dose assay pouches, can you just remind me, what the timing of that, that product is and what is of?

A - Henry Nordhoff

Management

Yes this is the so-called the TRUDER, I think we talked about the close units dose assay, probably the first manifestation will be in industrial testing. Lynda, can you provide some color on that?

A - Lynda Merrill

Management

It will the end, towards the end of '07, before the product will be available.

Q - Tycho Peterson

Management

Okay, thank you.

A - Henry Nordhoff

Management

You are welcome.

Operator

Operator

Our next question comes from Sara Michelmore, please state your company name.

Q - Sara Michelmore

Management

SG Cowen & Co, thanks for taking my question. I guess, on the guidance I just want a little clarification Herm, if I could in terms of the product revenue growth that you are expecting that's 15%, could you give us a sense in terms of what the trajectory would be for the clinical diagnostics versus the blood screening, that’s implied in that number?

A - Herm Rosenman

Management

Well, you know Sara, we don't break the math but what we have said is that at least in '06, it's more likely that blood screening will grow at a faster rate than diagnostics will.

Q - Sara Michelmore

Management

Okay and, on the sales and marketing guidance that you had in the press release, the way you got it restated sounded like most of the incremental there was going be invested in the oncology group, and I am just wondering what exactly do you plan to undertake in that group. Is that where the clinical trail expense would be or it’s just doubling at some infrastructure behind that oncology program?

A - Herm Rosenman

Management

As we expect to have a CE Marked PROCLEIX by the end of the year in Europe and so there will be an awful lot of all pre marketing spending in Europe as well as trying to get publication and marketing of the papers that we expect to have published here, Steve Kondor still on the line.

A - Steve Kondor

Management

Yes, I am Herm.

A - Herm Rosenman

Management

Steve, any further comments?

A - Steve Kondor

Management

The only thing, I would add is, we have a tremendous initiatives in place in Europe, we are looking people over there to begin doing the marketing clinical trails and generated the data for the European Urology Association meeting, creating awareness among the urologists about the value of PCA3 and we are doing the same things here in the United States.

Q - Sara Michelmore

Management

So the plan is and to take that product direct in Europe?

A - Steve Kondor

Management

That’s correct.

Q - Sara Michelmore

Management

Okay, and lastly, is these any update on the Panther system? Thank you.

A - Michael Watts

Management

We are, I did talk about Panther I think, middle of last year, we think, there is enormous market in the market sector that is not serviced by TIGRIS, that is from 10 to about 150 tests per day and we are evaluating some assays on our prototype instrument as we speak, so progress is being made.

Q - Sara Michelmore

Management

Thank you.

A - Henry Nordhoff

Management

Thank you Sara.

Operator

Operator

Our next question comes from Thomas Wei, please state your company name.

Q - Thomas Wei

Management

Hi Thanks, Piper Jaffray. I had a couple of questions, just one on the color Herm that you gave around the first quarter EPS. Should we interpret from that, that you mean, of a base that's $0.32 in the fourth quarter, we should strip out the $0.04 in one-time impact and it seems that the product sales growth increase will be offset by the cost in that first quarter EPS to be close to $0.28?

A - Herm Rosenman

Management

Your maths has always been good, Thomas.

Q - Thomas Wei

Management

I have a second math question here, it's just on the revenue guidance. So, if we take the low end of the product sales growth of 14% and I think you said that the bottom end of the of the collaborative research was 14 million and the bottom end of the royalty number was 7, that would total up to 331 not 325. Are you excluding something out of the base ’05 numbers in that calculation?

A- Herm Rosenman

Management

No we gave you a range, right, and that number is within the range.

Q - Thomas Wei

Management

Okay and then just one last question a follow-up on, like you just talked about on taking PCA3 direct into Europe, should we be taking the marketing and selling lines that you right now projected for '06 and assuming the peddle be dramatically accelerated in '07 as you were launching and rolling out PCA3 in Europe?

A - Herm Rosenman

Management

That’s what we have done with the '06 guidance before we worry about 2007.

Q - Thomas Wei

Management

Like I said conceptually should we be thing of you building at it similar selling and marketing infrastructure in Europe as you have in US?

A- Herm Rosenman

Management

We are in the process of looking for cooperative marketers. We are looking for drug companies with sales forces that do call on urologists so that we can share. I think it’s going to be unlikely that we will have our own sales force in Europe at the same level we have in the US. We are going to try and conserve our spending and for certain pharmaceuticals companies, they would love an opportunity to make a call with a newer product on urologist. So we think that time is not going to be very expensive for us to pay for. Nothing is worked out yet but we are looking at it very, very seriously.

Q - Thomas Wei

Management

Okay thank that's very helpful.

A- Herm Rosenman

Management

You are welcome Thomas.

Operator

Operator

Our next question comes from Russel Gilbertson please state your company name.

Q - Russel Gilbertson

Management

Caris & Company. Congratulations on a nice year guys. First question is the installed base for TIGRIS, you said it would double next year, does that include units that are used under investigational use. That’s the base you are growing from?

A - Henry Nordhoff

Management

Yes, it does.

Q - Russel Gilbertson

Management

Okay and can you just comment on the possibility of the modeling you are changing in terms of your testing and treating for STDs?

A - Henry Nordhoff

Management

Let me see if Steve is still with us again.

A - Steve Kondor

Management

Forgive me I am having a hard time hearing the questions coming in I can here you pretty well.

A - Henry Nordhoff

Management

Let me, Russ correct me if I am wrong. Is there anything happening with STD testing in Western Europe?

A - Steve Kondor

Management

STD testing in Western Europe is beginning to expand we've been successful placing instruments in particularly Northern Europe and as well in Japan. So those are the two areas where we STD business beginning to take hold. Northern Europe in the UK as an example we are beginning to place some TIGRIS in there and starting to now penetrate into other parts of Northern Europe and Japan. Those are the areas outside the US for STD business is beginning to takeoff.

Q - Russel Gilbertson

Management

Great and one more question for Herm if you would. Do you expect that the tax rate can be similar in '06 to what is standing in '05 and will be flat from quarter to quarter?

A- Herm Rosenman

Management

To answer your question it will be probably be slightly higher because we'll be making more to marginal at the highest marginal rate. And we hope it's not a lot higher because we hope the R&D tax credit is reinstated it has lapsed and happened also last year if you recall it was reinstated I believe in September so it could be a little lumpy, it’s probably not going to be until the third or fourth quarter when it's reinstated. But then it will be a little lumpy but we think we will finish the year at it at the number that we gave which is 37%, non-GAAP and 36% GAAP.

Q - Russel Gilbertson

Management

Thanks.

A - Henry Nordhoff

Management

Thanks Russ, before the next person comes on just want to say I am little disappointed I know you all read the press release and no one asked me about my day on Monday at the White House shaking hands with our President and accepting the National Medal of Technology award, but I mean if you still want to ask me and you better be happy to take any question.

Operator

Operator

Our next question comes from Lee Brown please state your company name.

Q - Lee Brown

Management

Merrill Lynch.

A - Henry Nordhoff

Management

Hi Lee.

Q - Lee Brown

Management

How's everyone doing out there. And just a quick question there on the National Medal of Technology award.

A - Henry Nordhoff

Management

It warms my heart.

Q - Lee Brown

Management

We talk about it after the call here. My congratulations, very strong quarter. Wanting to ask you about the stock comp progression obviously with FASB123 being in place looking at last year the sequence that are in terms of stock comp was 18%, 23%, 23%, 36% as a percentage of total comp and how that hit in the quarters? Are we are going to see a similar sequence in terms of stock comp being backend loaded or should we have more of a flat basis, I hate to be surprised by a heavy stock comp here in Q1?.

A- Herm Rosenman

Management

Yeah I don’t think you are going to see it back loaded like that, there's reasons that happened and what you are looking at which is a disclosure but I think it will be, don’t know what future grants will look like. But based on what's been granted so far I don’t think you are going to see that.

Q - Lee Brown

Management

Okay so if we think about the $0.30 to $0.35 it reasonable though it seems it survived that by 4 and plugged that in on a quarterly basis, that’s a fair assumption.

A- Herm Rosenman

Management

I think it is, yes. It's been around every on the quarter on a disclosures basis.

Q - Lee Brown

Management

Okay and then moving on to the R&D spinner with all the activities going on here. Should we assume that the $75 to $80 million of expenses is going to be more of a first half of event, I mean, obviously not all but how are your potion of R&D spent here in the first half as opposed with second half.

A- Herm Rosenman

Management

No you probably noticed that compared to last year we haven’t guided quarter by quarter on R&D. So at least this stage we see a fairly consistent throughout the year.

Q - Lee Brown

Management

Okay and then just clarification on the buyer legal cost where do you expect the proponents of those cost to hit and in what quarter. I believe you said you are going to trial on March, was that right or.

A - William Bowen

Management

This is Will Bowen. Right now we set for a pre trial conference in one of the cases in June. And I would expect the trial would take place within four months after that. And my best guess right now would be that the heavy expenses would be in Q3, Q4 a trial.

Q - Lee Brown

Management

Q3 to Q4. Any ballpark figures you are going to share on the cost of that?

A - William Bowen

Management

Not really at this time.

Q - Lee Brown

Management

Fair enough. And lastly in terms of product gross margin and then I'll get off and I believe Sarah was referring this, as the West Nile Virus commercial pricing takes place at least on the 2/3 of that eSAS here and progress is going to eventually with the TIGRIS approval, how should we think as product gross margin ramping to the full year run rate?

A - Herm Rosenman

Management

Well as you know we also haven’t given any specific guidance on that as sometimes we did in the past. So you know it’s going to ramp in the second half of the year right. Because that's when the commercial pricing and increase cost recovery pricing will take place so I would take it from there.

Q - Lee Brown

Management

Okay thank you very much.

A - Henry Nordhoff

Management

Operator I think we might have time one or two more questions then we'll have the closing remarks.

Operator

Operator

Okay I have two question up, your next question from Benner Ulrich please state your company name.

Q - Benner Ulrich

Management

UBS. Hey guys. Most of my questions have been answered I just had one follow up I think you mentioned in the prepared remarks that Chiron, next year was targeting for additional markets internationally for blood screening. I don’t think you mentioned what those were or quantify what potential opportunity was in terms of contemplate the big guidance but just wondering if you can give some detail on that?

A - Herm Rosenman

Management

Well you are right. We haven’t and really don’t have all the details from Chiron on that, Benner.

Q - Benner Ulrich

Management

Okay and is that something I guess the timing you wouldn’t necessary know either. I mean is that something that they would, it would be early in the year or more likely in the second half of the year?

A - Herm Rosenman

Management

It would be probably be phased throughout the year but I wouldn’t expect a huge amount to be showing up. I think that the next big market we are really shooting for is Japan.

Q - Benner Ulrich

Management

Right.

A - Herm Rosenman

Management

That's because of it’s size and we have been a little bit guarded but we do expect to get some sales we don’t know when, we don’t how much.

Q - Benner Ulrich

Management

Okay, fair enough, thanks guys.

A - Herm Rosenman

Management

Thanks Ulrich

Operator

Operator

And our last question come Thomas Wei please state your company name.

Q - Thomas Wei

Management

Oh, Piper Jaffray thanks for taking a follow up. Just a follow question on that, if it is not really major international countries in where is the TIGRIS, the doubling at the TIGRIS install base coming from. Is that much more on the diagnostic side?

A - Herm Rosenman

Management

Herm, Thomas. Not actually it is more on the blood screening side. We think Chiron will find homes for all of those TIGRIS instruments in the near future. They haven’t given us a lot of color as they did on their conference call as to which countries but they did say there would be four countries that they are targeting amongst others. And they give us as may recall a 12 month growing forecast that's how we get it in our guidance. The first few months or the first 90 days so that is equivalent to a purchase order after that it not quite as tight but that's how we include it in the guidance.

Q - Thomas Wei

Management

And I think, they are already have partners to those machines in '05?

A - Herm Rosenman

Management

No the have not purchased and this is again 3 months purchases orders so we have a pretty good grasp on that and then the remaining 9 months of the year also pretty good grasp on but not the same experience.

A - Henry Nordhoff

Management

Thomas in a way of clarification to Benner's question and my reply was not intended to in anyway minimize the international growth we expect next year. Because we are going to get on awful lot of annualization for the full year in 2006. So those new countries that Chiron picked up in 2005. I just can't think of any very major countries that are coming online this year.

Q - Thomas Wei

Management

All right thanks.

A - Henry Nordhoff

Management

You're welcome.

Henry Nordhoff, Chief Executive Officer

Management

Well thanks for all your questions to warp up Gen-Probe had a strong fourth quarter and full year 2005. We continue to generate growth in both our clinical diagnostics and blood screening businesses. Fourth quarter product sales grew by a robust 33% over the prior year and established a new record for the 13th time in 14 quarters. As a result total revenues grew 28% and earnings per share increased a very strong 39%. As we were churning out the substantial growth we also made important headway and pursue a several short, medium and long-term opportunities. As a result we entered 2006 on a very solid footing. Over the balance of this year we anticipate delivering growth and product sales and earnings per share in line with our long-term goals while also investing heavily on R&D, doubling our install base of TIGRIS system and delivering exceptional profit margins. Thanks you all for your time and attention today and please contact us if you have any follow up questions. Thank you very much.

Operator

Operator

That concludes today call, please disconnect.