Earnings Labs

GoPro, Inc. (GPRO)

Q3 2009 Earnings Call· Fri, Oct 30, 2009

$1.52

+9.78%

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Transcript

Operator

Operator

Welcome and thank you for standing by. At this time all participants' lines are in a listen-only mode. At the end we will conduct a question and answer session. (Operator Instructions) Today's conference is being recorded. If you have any objections you may disconnect at this time. Now I'd like to turn the call over to your host Mr. Mike Watts.

Michael Watts

Management

Thank you Christian and good afternoon everyone. I am pleased to welcome to you to this conference call to discuss our third quarter 2009 business results. A press release announcing our results was issued today just after 4:00 PM Eastern Time and is posted on our website at www.genprobe.com. In today's call, Carl will review our revenue results and strategic progress, then Herm will discuss expenses and our updated financial guidance. We'll take your questions for the balance of an hour, then we'll post our prepared remarks on our website for your convenience and reference. 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 about our expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements. For example, statements concerning 2009 financial guidance, financial condition, regulatory approvals and timelines, possible or assumed future results of operations, growth opportunities, plans and objectives of management, and future economic conditions are all forward-looking statements. These statements are not guarantees of performance. They involve known as well as 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 are not limited to, those discussed in our SEC filings, including our report on Form 10-K for the year ended December 31, 2008, and all subsequent periodic reports. Copies of these reports are available on our website, at www.sec.gov and on request from our Investor Relations department. Gen-Probe assumes no obligation and expressly disclaims any duty to update any forward-looking statements to reflect events or circumstances after the date of this call or to reflect the occurrence of unanticipated events. In addition, our presentation today includes information presented on a non-GAAP basis. We believe these non-GAAP financial measures provide meaningful supplemental information regarding the company's performance by excluding certain expenses that may not be indicative of core business results. We refer you to the press release we issued this afternoon, which is available on our website, for a reconciliation of the differences between the non-GAAP presentations and the most directly comparable GAAP measures. Now I'll turn the call over to Carl Hull, Gen-Probe CEO.

Carl W. Hull

Management

Thank you, Mike. And good afternoon everyone. Gen-Probe had a very busy and very productive third quarter of 2009, both operationally and strategically. In terms of our operations, we established new sales records for STDs, clinical diagnostic products and total revenues. We delivered total revenues of $122.7 million right in the middle of our guidance range and at same time kept a tight lid on expenses which boosted our operating profitability. We also used our balance sheet to capitalize on our temporarily depressed share price, completing our $250 million share repurchase plan faster than originally planned. All this led to non-GAAP earnings per share of $0.47 in the quarter, which we believe represents very good operational performance. In terms of our strategy, we tightened our focus on growing profitable human diagnostic opportunities where we can leverage our core competencies and deliver clinically meaningful products. We spun off our industrial testing assets, closed the Prodesse acquisition, and initiated U.S. clinical trials for our prostate cancer and trichomonas assays . With that prologue, let's get into the details. In the third quarter, total revenues were a record $122.7 million, up 1% compared to the prior year period. Keep in mind that in the third quarter of last year, we recorded a $10 million milestone from Novartis associated with the full U.S. approval of the PROCLEIX ULTRIO assay on the TIGRIS system. Excluding this non-recurring collaborative research revenue, total revenues would have grown by about 10% this quarter. Product sales in the third quarter established a new record of $119 million, up 10% versus last year. Foreign exchange remained a headwind compared to the prior year, reducing growth by about 2%. In other words, product sales grew 12% on a constant currency basis. Our core STD testing business had an especially good quarter,…

Herm Rosenman

Management

Thank you, Carl and good afternoon everyone. Let me begin by discussing non-product revenues. Collaborative research revenue was $2 million in the third quarter, down significantly from a year ago. As discussed, this decrease resulted from a $10 million milestone we earned from Novartis in the prior year period based on the full U.S. approval of the ULTRIO assay on the TIGRIS system.. Royalty and license revenue was $1.8 million in the third quarter, up 13% compared to the prior year period and a little higher than expected based on the timing of several items. Royalties received from Novartis for the use of our technologies in the plasma screening market continue to be the largest component of this line. Now let me turn to expenses. As Carl mentioned, Gen-Probe's profitability improved on a sequential basis in the third quarter, based on a less onerous foreign exchange environment than in the second quarter, and very deliberate efforts to manage our cost structure. Both our gross and operating margins improved by more than 200 basis points compared to the second quarter of 2009, and expense management will continue to be a focus going forward, even as we continue to invest appropriately in key strategic initiatives to drive future growth. Gross margin on product sales was 69.5% on a non-GAAP basis in the third quarter, down from an exceptional 71.7% in the prior year period. Compared to last year, gross margin declined primarily due to the stronger U.S. dollar, which reduces our profitability, and the addition of lower-margin Tepnel revenues. Research and development expenses for the third quarter were $27.5 million, up 12% compared to the prior year period. This increase was due mainly to expenses associated with clinical trials of our HPV, PCA3 and trichomonas assays, and the addition of Tepnel's R&D…

Michael Watts

Management

Thanks Herm. Members of management who are joining us for Q&A are Bill Bowen, senior Vice President and general counsel; Steve Kondor, senior Vice President of sales and marketing; Eric Lai, senior Vice President of R&D; Eric Tardif, senior Vice President of corporate strategy; and Kevin Herde, our Vice President and corporate controller. In order to ensure broad participation in the Q&A session, please be courteous and limit your questions to one plus a follow-up, then jump back into the queue. I really appreciate your cooperation in this regard, since in our last call, I understand that several of you were left waiting in the queue at the end of our hour. So Christian, I think we're ready to take the first question. Operator? Christian can you hear us?

Operator

Operator

Thank you (Operator Instructions) Our first question comes from Mr. Imron Zafar from Deutsche Bank. Sir your line is open.

Imron Zafar

Analyst

Hi good afternoon thanks for taking question. My first question is on the Prodesse H1N1 testing, can you just explain what the utility of this would be, how will it be used? In other words right now if you are suspected to have H1N1 and you test positive for influenza A or you're pretty much given Tamiflu. How do you see this test being used going forward?

Eric Tardif

Analyst

Hi Imron, this is Eric Tardif. First of all the protocol that we see being used and we think that clinicians are going to adopt is to first screen with the ProFlu+ test which as you indicated would detect the presence of H1N1 if it's there. And subsequently if there is a desire to sub-type in to figure out whether the flu is in fact H1N1, to run the prove ProFlu-ST which is the sub typing assay. The utility comes very simply from the fact that there is an increasing to know what flu strain is present because some of them do respond to antivirals and others do not.

Imron Zafar

Analyst

Okay and then just on the Prodesse asset again, so you talked about 15 million in revenues in 2010. Herm, can you just talk about the seasonality of this business, how we should think about it for modeling purposes for 2010 and beyond? And then Carl maybe just give us a little bit of peek into the pipeline of this --

Herm Rosenman

Management

Imron it's early days for us and we are not all that familiar with the business. Obviously we are talking about flu here, so it probably has some seasonality but, at this point we're certainly not going to give 2010 guidance but nice try.

Carl Hull

Analyst

Yeah Imron, I would add to that by saying that I think all bets are off in terms of previous patterns the seasonality of flu test and products of all kinds, things are obviously happening today that are very different than historical patterns. And having been the owner of the business for what seven working days now, I don't think any of us want to, how it goes as to how that seasonality is actually going to pan out. We're doing everything we can obviously to maximize the immediate opportunity that's in front of us and I think based on the initial feedback from our sales team that opportunity is a robust one. With respect to the pipeline you could expect to see Prodesse continue to focus on respiratory infectious diseases of all types. I think if we draw back the clock about six years, you can see a clear pattern of every couple of years, a fairly significant novel pathogen emerging is a threat on a global basis. Prodesse will be certainly very well positioned and very well prepared to provide assays to assess those threats as they emerge, additionally those have (ph) c.diff assay and we will clearly maximize our sales efforts with that product as well.

Imron Zafar

Analyst

Great, thank you very much.

Carl Hull

Analyst

You bet.

Operator

Operator

Our next question comes from Mr. Quintin Lai from Robert Baird. Sir your line is open.

Unidentified Analyst

Analyst

Good afternoon this is actually Matt Atoriani for Quintin. Thanks for taking my question guys.

Carl Hull

Analyst

Hey Matt.

Unidentified Analyst

Analyst

Just kind of going off with Imron's first question, I was just wondering do you guys have a feel for the percentage of market share the Prodesse has for NAT based respiratory testing at all or --

Herm Rosenman

Management

And what we -- I don't that we're going to give that specific guidance today. We do think that it's early days for PCR based full testing and there's obviously a notable competitor out there in Luminex and we think that we're holding our own genre in the marketplace. But we don't have perfect visibility, I don't think we're going to guide to that. .

Carl Hull

Analyst

Yes Matt, we will clearly develop our own views of the market over the of course the next couple of quarters and much like we do with our STD business manage our performance using market share as the key tool doing that.

Michael Watts

Management

Hey Matt this is Mike, just to add to that. I mean clearly, the molecular test as a whole or a relatively small piece of the overall flu market, we think there's a pretty significant opportunity to provide added clinical benefit over the rapid antigen test which tend to have fairly low sensitivity as well as expand this relative to some of the home brew tests that are out there. So we certainly think there's room for growth for the category as a whole.

Unidentified Analyst

Analyst

Great thanks for all that color. As a follow up and this is just kind of a longer-term with this Prodesse, you bring PCR into the product menu offering. So, just help us out of me, how should we think about menu expansion going forward? Is it going to be more technology and platform agnostic and more focused on different areas or any detail there? Thanks.

Carl Hull

Analyst

Yeah Matt that is a good characterization. We are looking for market opportunities where there are unmet clinical needs and where we think some of the technologies that we don't have in hand today or that are out there, offer solutions to those these clinical needs, we're going to be technology agnostic about those. Having said, we clearly think there's lots of opportunity for continued new assay development both on TMA and now with PCR platform and we will pursue those aggressively. Okay operator we're ready for the next question.

Operator

Operator

Our next question comes from Dan Leonard from First Analysis. Sir your line is open.

Dan Leonard

Analyst

Thank you. I have a question on the guidance. So Prodesse now in your revenue forecast but you didn't increase your revenue guidance. So, what is the offset?

Herm Rosenman

Management

Okay. Well we came in as we said right in the middle of our range right? It also said that expenses for all of the major expense lines are going to increase, so that certainly implies that our revenues are going to be up fairly substantially in the fourth quarter. But we also mentioned legal expenses, so we are going to see some additional legal expenses and we are not exactly sure what the timing or amounts of those will be. We talked about the timing of R&D expenses. We have three clinical trials underway, so there's a lot of variability that could happen. And we also talked about other income specifically the unrealized gains or the gains that we've actually realized this year in the absence of those going forward. And so that is in a variability there that and we're really just talking about fairly small amount money right, by 1% or so. So I think that should give you enough information to be able to figure it out.

Dan Leonard

Analyst

Okay and my follow up, which I think is related, do you have any insight into what Novartis's expectations were for West Nile season and that's how the season is tracking according to their plan?

Carl Hull

Analyst

I don't think that Novartis's expectations of the West Nile virus were much different from how we saw it. Clearly this season had a lower incidents of disease and infection identified compared to I guess boom season of couple of years back. So, it had a lower level this year than we have seen in the past. I think right now, the triggers and then the time triggers and other things are in place and we expect the experience like we had this year continue on a go forward basis.

Dan Leonard

Analyst

Thank you.

Carl Hull

Analyst

Operator.

Operator

Operator

Our next question comes from Mr. Bill Quirk from Piper Jaffray. Sir, your line is open.

Bill Quirk

Analyst

Thanks. Good afternoon congrats on the Prodesse deal.

Carl Hull

Analyst

Thank you Bill.

Bill Quirk

Analyst

Hi Carl just thinking a little bit, I guess on the guidance question here, looking at the midpoint of the revenue guidance if I am doing by math correctly, we're looking at a pretty big call it 14 to $15 million sequentially increase. I understand that Prodesse effectively offset the industrial business. But can you just help us think about the level of confidence you guys have in this number. And I guess the increase, but I guess we should be expecting that largely in clinical diagnostics.

Carl Hull

Analyst

Well we've got a couple of things going on. We're clearly seeing strength in clinical diagnostics, there is no question about that. But, I think we also indicated that we expect to see the downtick that we've experienced in last couple of quarters, that we saw year-on-year basis in blood screening to have reversed. So, we do feel that the forecast for the last quarter is a solid one and I would say in total other than the addition of the new revenues which we just don't have, hard track record Prodesse to give you a gut feel for, we feel pretty good about this forecast.

Bill Quirk

Analyst

Okay. Very good. It's a follow up, how are we thinking deploying the balance sheet now to make sense to continue with the recent acquisition strategy?

Carl Hull

Analyst

Well, we're still going to be active in looking for similar opportunities because we think some of those are out there today. But I think we would characterize on just based on what we have done. What you see with Tepnel, what you see with Prodesse are acquisitions that make good sense to us and to our shareholders. And if those similar opportunities to present themselves, we'll go after them for sure but again we don't see big dilutive deals out there that make intuitive or strategic sense to us right now.

Bill Quirk

Analyst

Thank you.

Carl Hull

Analyst

You bet.

Operator

Operator

David Lewis from Morgan Stanley, your line is open.

Marshall Urist

Analyst

Yeah hey guys, it's actually Marshall in for David. Couple of questions, the first one you mentioned the R&D reorganization, why don't you talk about it a little bit more and you also mentioned that could increase through the number of programs that you would be able to sort of have in the channel at any one time. So what are the implications here for spending, is this is it in line with your previous expectations for long term R&D or does this give you flexibility to increase or actually move in the other direction?

Carl Hull

Analyst

Yeah Marshall we do feel the reorganization allows us to be more efficient and by that I mean to do more programs and a greater progress with comparable or similar levels of resources. So, I don't think it signals anything different in terms of the overall spending profile and where we're headed with R&D. Let me ask Eric Lai to comment specifically on some of the elements of the reorg and what we think it will do for us.

Eric Lai

Analyst

This is Eric Lai. The re-org basically turned the organization from a functional alliance into project specific alignments. So, that we decreased the ten off and minimized the interfaces and maximized the efficiency and at the same time support the corporate strategy and allow us to do hopefully more projects with the same type of resources. And also allow us to absorb and align ourselves with all these new acquisitions at the same time and they get efficient instead of just there's something I want to do?

Carl Hull

Analyst

Yeah Marshall I don't know if you got your Blackberry on vibe. We're getting some interference.

Marshall Urist

Analyst

Okay, yeah there is, I just tossed it over, so hopefully that'll help. And maybe just this is a -- maybe this is a stretch of the related follow up. I was wondering also if you could talk about help us to understand just what's your thinking on the timing around the BDK? And sort of what is the goal here? Is this in response to something that you are seeing from a competitive point of view? Thanks.

Carl Hull

Analyst

Yeah, I don't think we can give you a lot of color there Marshall, each one of these kinds of litigation has a life of its own in effect. So there will be fixed time tables for their responses to us and that sort of thing and we'll see how those progress. We don't -- we expect spending to begin almost immediately because that's the way these kind of cases go, but we'll not have resolution if it goes all way through litigation for as much as a couple of years or longer. So, there is a wide range in there and I can't give you anymore specifics than that. With respect to your question about what's the signal with respect to competition et cetera, all I can tell you is there are variety of considerations that go into filing a case like this. I don't think we care to go into any of them in detail, but suffice it to say that there was a lot of analysis and thought that went into our decision making process here and we feel this is the right thing to do at this juncture.

Marshall Urist

Analyst

Okay. Great. Thanks a lot.

Carl Hull

Analyst

You bet.

Operator

Operator

Our next question comes from Mr. Brian Weinstein from William Blair. Sir your line is open.

Brian Weinstein

Analyst

Thank you, good afternoon. Starting with blood screening I just want to make sure that we kind of parse this out a little bit, you said unit volume was up 1%, can you tell was that U.S. or worldwide?

Carl Hull

Analyst

That was a worldwide number of 1% and we have visibility now in our revised relationship to the donations that are effectively built by the collaboration. So, it's a global number.

Brian Weinstein

Analyst

Do you have any idea what it was in the U.S.? And the reason I ask is that we consistently were hearing about the drop off cases year-over-year even though the summer months are typically light due to anything from the economy to, even to H1N1 effect and even some changes in the teen requirements for donating. Have you seen anything like that?

Carl Hull

Analyst

Yeah I think it's hard for us to extract a pattern out of the U.S. from the numbers that we see. I can tell you that you're right, the previous quarter is the slowest one because the summer months and in particular I think we say probably July was one of the lower months of the year. Is that economy related or is it vacation dependent, we really don't know those kinds of things. The growth rate will be slightly higher outside the U.S. but the other than that I can't give one more thought.

Brian Weinstein

Analyst

Okay and then second question, do you guys plan on keeping the Prodesse reference lab that they have there? And do you intend to use it until you potentially launch Tasavir (ph) --

Eric Tardif

Analyst

So the first -- the answer to the first question is yes, we do intend to keep the lab that they have there. As you know it's not a dominant part of the business right now. It's a relatively small part of the business. And I think we're going to investigate what we can do with it in the future but we don't have plans yet to change the business model.

Carl Hull

Analyst

Yeah I think we would say Brian, the nature of that reference lab is actually a potentially valuable public health resource. Especially when you get in first time and lots of testing are being done and there have been times when the lab's just something that can't cope with volume of specimen and that's a valuable place for this kind of specialized testing to go.

Brian Weinstein

Analyst

Okay great, thank you very much.

Carl Hull

Analyst

You bet.

Operator

Operator

Isaac Ro from Leerink Swann, your line is open.

Isaac Ro

Analyst

Hi good afternoon, thank you for taking the question.

Carl Hull

Analyst

Hi.

Isaac Ro

Analyst

Hi first off on Prodesse I was just wondering if you could maybe offer a little detail on your earnout structure and maybe specifically if you could talk a little bit about whether -- or how it's broken down in terms of revenue growth targets and maybe if there's a profitability mandate included as well?

Carl Hull

Analyst

So I think what I'll tell you there is what we communicated publicly which is that, there are regulatory milestone based payments and there are basically financial performance based payments. And the majority of the earn-out is really related to the latter, so to the financial performance of the business. Beyond that I don't think we are going to give more granularity.

Isaac Ro

Analyst

Great thanks very much. Secondly, on the flu I just wanted to see if you could comment a bit more on the notion of sort of confluence of the seasonal H1N1 strains that you mentioned earlier. Are you getting that sort of a data point from sort of nationwide among various hospitals or is it something that you are getting maybe from your contacts within CDC or sort of international agencies?

Carl Hull

Analyst

I think that we are experiencing H1N1 and flu at the same time as everybody else is right now and we don't know ultimately what's going to happen with the patterns. But, certainly there is evidence that it is here to stay and that it will and has begun to overlap with the other seasonal patterns. And beyond that what happens next year and how it behaves we simply don't know at this point.

Isaac Ro

Analyst

Got you, Thank you very much.

Carl Hull

Analyst

Thank you.

Operator

Operator

Our next question comes Mr. Zarak Khurshid from Caris. Sir, your line is open.

Zarak Khurshid

Analyst

Close enough. Good afternoon guys. Thanks for taking the questions. I wasn't not sure if you guys broke out Tepnel molecular revenue in the quarter, if you could that'd great. And what was the core growth of the STD business if you strip that out?

Herm Rosenman

Management

Yeah, we did not break it out, it's included in our clinical diagnostics business. And therefore we're not going to strip it out either.

Michael Watts

Management

Zarak, this is Mike. On the second piece of that, we did say in our script that the core STD business was up in the low teen, sure as detail that has, what your model is and kind of figure out from there.

Zarak Khurshid

Analyst

Sure, great thanks and then as a follow up. Just going back to the Prodesse acquisition any color on the C.diff product and any market share gains versus the rapid immunoassay in light of the beta tests and generally how are you thinking about kind of the C.diff opportunity versus influenza long term in your mind? Thanks.

Eric Tardif

Analyst

Right, so it is early days for the C.diff product. We do think that that's going to be a compelling product in its applications which is really, not really an HAI kind of test but much more of a diagnostic for C.diff. Labs are validating and are considering the test but as you can imagine right now the predominant focus has been on the flu test. In the long run we think that, that could be a good product but we're going to give it some time to develop

Carl Hull

Analyst

Go ahead operator.

Operator

Operator

Our next question comes from Mr. Anthony Petrone from Maxim Group. Sir your line is open.

Anthony Petrone

Analyst

Thank you. One on guidance here and then another follow up on PANTHER. On guidance if we take a look at the mid point here and we assume that's really a follow up to Tepnel, if we take a look at and assume -- should we assume low teens growth again for STD in the fourth quarter as more of the revenue contribution in that quarter reflected in HLA?

Herm Rosenman

Management

Yeah, I think we said that it was going to be pretty -- we implied it was pretty equivalent growth and that will be driven by APTIMA Combo 2. So we're probably looking at low teens, growth continuing in clinical diagnostics.

Michael Watts

Management

It's Mike. Just one thing to keep in mind of course is, if you look at the prior year periods, those do tend to jump around a little bit. So you've got to make sure you keep the comp issue in mind. I think second quarter of last year for example was a really big comp and third quarter of last year was not so big. So just keep that mind as you are working through it.

Anthony Petrone

Analyst

Yeah it's very, very helpful. And Carl you mentioned last quarter on, in regards to PANTHER 20 units running on a 24 hour cycle. You went to the finalist hardware design an integrate assays. Just wondering where that is, is hardware finalized now and how many assays are now compatible on the system?

Carl Hull

Analyst

We are on schedule with the PANTHER program against all of these major milestones, the program recently completed our phase get review of our development process successfully. And we continue to increase the number of instruments that we have in hand. We'll move to final log validation work early next year and it's all on schedule.

Anthony Petrone

Analyst

Great thanks.

Carl Hull

Analyst

You bet.

Operator

Operator

Spencer Nam from Summer Street, your line is open.

Spencer Nam

Analyst

Hi thanks for taking my question. Just have a one question, since I can't get to specific with the limit to questions. Your pipeline -- would you generally characterize your pipeline to be on schedule in terms of where the trials are and when you guys expect some of the new assays to hit the market, U.S. market in particular?

Carl Hull

Analyst

Yeah, I think we are very comfortable that from a time point of view, we got the major programs on schedule beginning with PANTHER, obviously in the midst of the HPV trial and driving to conclusion for that trial which is our biggest endeavor. And then we announced last quarter the addition of the two other trials for the components in PCA3 here in the U.S. And we began those studies as we anticipated and enrollment is underway in both so, we feel pretty comfortable.

Spencer Nam

Analyst

Great thanks.

Carl Hull

Analyst

Thank you Spencer.

Operator

Operator

Our next question comes from Mr. Eric School from Thomas Weisel Partners, sir your line is open.

Unidentified Analyst

Analyst

Hey good afternoon guys. It's Eric in for Peter.

Carl Hull

Analyst

Hi Eric.

Unidentified Analyst

Analyst

So I guess, now that you have PCR related platform, how do you see the when the PCR royalties start rolling of in 2011-2012 how do you see that affecting your business as far as the product development?

Carl Hull

Analyst

Well I don't think we'll comment on the PCR patented stake, it's a fairly complex one from my recent memory. I would just say that we think that the licenses in the business that we've acquired are sufficient to allow us to do a number of different things in the space. We are comfortable with it and we are going to exploit all the related commercial opportunities we can identify

Unidentified Analyst

Analyst

Okay and then just one follow up on that, any plans on developing a PCR dedicated instrument or maybe an instrument that runs both assay platforms?

Carl Hull

Analyst

Right now we have access to a platform that's already in the field, throughput that's on the supply arrangements they have in place. We feel comfortable with that solution be an adequate for the testing that's out there today. Will we evaluate opportunities for integrating platforms? Yeah, of course we will do that just as we have done and do with our Tepnel related technologies. But that's more part of the routine business.

Unidentified Analyst

Analyst

Great thanks.

Carl Hull

Analyst

Thank you.

Operator

Operator

Sumit Harish from Needham & Company, your line is open.

Sumit Harish

Analyst

Hi, thanks for taking the question. Wanted to start off by following up on the market share question in terms of flu, can you maybe speak a little bit in terms to availability of systems at the hospital level compared to the competitive technologies?

Carl Hull

Analyst

Yes, so I'll take that. It is pretty clear to us that the systems on which Prodesse assays run are pretty widely distributed as they stand right now on this quite broad acceptance of the platform. As you know the assays are principally cleared on the smart cyclo system. And so the availability of systems has not been a hindrance to the placement of new accounts and clearly continues to provide those systems and continues to be able to support new account introductions.

Sumit Harish

Analyst

Okay and the second sort of a similar follow up, in terms of new account validations for the Prodesse test, as you move into some of the existing Gen-Probe accounts that haven't done the test. What's the validation timeframe and do you think keeping that in mind you can get significant contribution in this flu season from new customers or is that more of a next year flu season event?

Carl Hull

Analyst

I think the validation time period is pretty account specific. What I would say is that our sales force has ramped pretty quickly to start addressing new accounts and introduces -- and we are seeing interest in validating the test in terms of how many of those were materialized in the current season, I think we just don't know.

Eric Tardif

Analyst

But Sumit to elaborate on that, we have a -- actually are in the process even this week of training our field technical folks on the assays of technical provider, direct support to customers. And I think you know we have a very good track record of being able to get quite complex multi assay TIGRISes up and running in a relatively rapid fashion in our existing customer base. So we think this is much more straight forward endeavor focused on one or a couple of assays and it's something that's right in the sweet spot of our field technical team.

Operator

Operator

Sara Michelmore with Cowen, your line is open.

Sara Michelmore

Analyst

All right great, thanks for taking my question. Carl I was hoping you could just give us a quick update on where the European commercial expansion stands? I know a lot has changed since you close the technology interested in terms of the data three port there and what we should think about going forward. Herm had mentioned that maybe the product acquisition with required investment as well, it will be worth some investments, so just curious in terms of how we should think about that? Thanks.

Carl Hull

Analyst

Let me ask Steve Kondor to comment on that.

Stephen Kondor

Analyst

Sara, I can say that we're on track in terms of our European expansion initiatives. We have sales people, service people and tax report people in all the major countries now in Europe. We have an office that's opening up the end of this year, and we're great pleased with the addition of these sales people in terms of contributions that they have made to date on the top lines. So everything is going very well there. With regard to your last question, comment regarding of Prodesse, Prodesse has a few distributors in Europe but primarily, our sales people will be selling that product line direct in and they are right now after acquisitions, are being trained on the product line and are looking at very forward to being able to place those products correctly in the countries where we have dedicated sales people?

Sara Michelmore

Analyst

Is the bulk of the build out behind the company, is that fair to say at this point?

Carl Hull

Analyst

Let say that we've got the necessary building blocks in place, Steve articulated in the major markets where we want to play. We tend to use this model of having both our field support, our sales guys put in place to get things going. After that you would see an expansion model that we focus on really revenue based opportunities and I think you add sales people to that model as you see the opportunities being large enough in the individual countries. So you should expect to see future expansion there but it won't be kind of bullish as we've done until this point.

Sara Michelmore

Analyst

Okay. And then my last question is on HPVU coming to the end of the clinical trials here hopefully in the next several months, when should we think about seeing or getting a good look at that data set? Is there any sort of time target you are thinking about or a strategy in terms of data determination? Thanks.

Carl Hull

Analyst

Yeah, I think Sara that we've said that filings will go in by the fourth quarter of next year. We're on track with that. As you know with a data set in the trial as large as this is, it will be hard to have interim publications or piecemeal publications. So we will really take the entire data set and then work out publication strategy thereafter. But it's hard for me to give you a visibility to say hey you could expect to see that prior to this --

Sara Michelmore

Analyst

Okay. Thanks so much.

Michael Watts

Management

Thanks. Fred, I think we got time for one more and then we will have, very brief closing remarks.

Operator

Operator

Thank you. Our last question comes from Amit Hasson from Oppenheimer. Sir your line is open.

Carl Hull

Analyst

Amit, are you there?

Unidentified Analyst

Analyst

Can you hear me? This is Lisa filling in for Amit. This is actually --

Carl Hull

Analyst

Hi.

Unidentified Analyst

Analyst

Hi, a follow up on the last question, so you guys have recently presented some findings from the trial where you had a specificity that was 20 points better specificity, stayed the same. And we were just wondering when we should be expecting the final results from that study and what will be the impact of that data?

Herm Rosenman

Management

You can expect to see that data in its final format presented at the European conference in the first quarter of next year in Europe.

Carl Hull

Analyst

And we should take, as we did not respond to Sara's question, there will continue to be publications of marketing driven clinical studies from Europe in the period of time as we are doing our U.S. submission so that, that will be an ongoing process. Okay. With that, I would like to just thank you all for your questions and to wrap up, Gen-Probe had a good third quarter. Operationally we combined solid revenue growth which was driven by strong results in our core STD business, with good leverage in the middle of the income statement, to generate bottom-line outperformance. Strategically, we made significant progress in building our aggressive, focused company by spinning off the industrial business, acquiring Prodesse and beginning key clinical trials. Before we sign off, let me remind you that our prepared remarks will be posted on our website momentarily, and we encourage you to refer to them if you missed a fact or a number during the call. In addition, we hope to see many of you at our annual analyst day the morning of Thursday, December 3, at the NASDAQ Market Site in New York. Please contact Mike or Paula if you would like to RSVP. Thank you for your time and attention today, and please call us if you have follow-up questions.

Operator

Operator

Thank you for participating. Today's conference has concluded. Please disconnect.