Earnings Labs

GoPro, Inc. (GPRO)

Q3 2008 Earnings Call· Fri, Oct 31, 2008

$1.47

-3.29%

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Transcript

Operator

Operator

Welcome, and thank you for standing by. At this time, all participants are in a listen-only mode. [Operator Instructions]. Today's conference is being recorded. If you have any objections you may disconnect at this time. Now, I would like to turn the meeting over to Mr. Michael Watts, Senior Director of Investor Relations and Corporate Communications. Thank you, sir. You may begin.

Michael Watts

Analyst · Leerink Swann. Sir, your line is open

Thank you, Mary, and good afternoon everyone. On behalf of our management team, I'm pleased to welcome you to this conference call to discuss our Third Quarter 2008 Business Results. A press release announcing our results, was issued today just after 4 p.m. Eastern Time and is posted on our website at www.gen-probe.com. In our call today, Hank will first provide a deeper [ph] perspective on our performance in this difficult economic environment. Carl will cover our revenue results, then Herm will review quarterly expenses and our revised 2008 guidance. We will take your questions before wrapping up in an hour. Immediately after that, we will 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 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 through the use of words and phrases such as believe, will, expect, anticipate, estimate, intend, plan, foresee, could, should and would. For example, statements concerning 2008 financial guidance, financial condition, regulatory approvals and timelines, possible or assumed future results of operations, growth opportunities, industry rankings, plans and objectives of management and future economic conditions 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 are not limited to, those discussed in our SEC Filings including our report on Form 10-K for the year ended December 31, 2007, 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 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. With that administrative detail out of the way, I'll turn the call over to Hank Nordhoff, Gen-Probe's CEO.

Henry L. Nordhoff

Analyst · Robert W. Baird Co. Sir, your line is open

Thank you, Mike, and good afternoon everyone. As you saw from our press release, Gen-Probe had a very good third quarter on the top line, and especially on the bottom line. Total revenues grew 19% to $121.2 million, and this combined with operational leverage enabled EPS to increase by 71% to $0.53. I believe our financial performance reflects Gen-Probe's enduring ability to generate consistent growth and profitability, in the face of the deteriorating macroeconomic conditions over the last few months. No company, even in healthcare, is completely immune from long-lasting economic upheaval, but we believe we are more insulated than most today, because of the vital nature of our two businesses. So before we discuss our detailed quarterly results, let me take a step back to highlight a few items from our income statement, our cash flow statement and our balance sheet, and illustrate why we believe we can be a solid investment for tough economic times. First, the income statement. Both our businesses, clinical diagnostics and blood screening showed good growth in the third quarter, even though we had a very tough comp in diagnostics due to some one-time instrument sales in the prior year period. I know there has been a lot of concern in the financial community about hospitals cutting back on capital spending, and patients deferring medical visits to save on co-pays and the like. But we have not been negatively affected by these issues to date. We believe there are a couple of reasons for this. First, the vast majority of our clinical diagnostics sales, probably 95% or more in a typical quarter, are consumables based. In fact, we often place our instrumentation in the customer's lab on a reagent rental basis, meaning a customer is not required to make an upfront capital outlay. Instead,…

Carl W. Hull

Analyst · Piper Jaffray. Sir, your line is open

Thanks Hank, and good afternoon, everyone. I'm going to review our product sales performance in the third quarter, and report on the status of ULTRIO in the United States. Product sales were $108.3 million in the quarter, representing solid growth of 11% compared to last year. Both our clinical diagnostics and blood screening businesses were healthy. Clinical diagnostic sales were $55.5 million, 7% higher than in the prior year period. It's important to remember that in the third quarter of last year, we recorded approximately $3 million of incremental one-time instrument sales to clinical diagnostic customers. We said at the time that this was a very unusual event and in fact it has not recurred. If we strip this $3 million out of the prior year period, clinical diagnostic sales would have grown between 13% and 14%, consistent with the second quarter rate and much more reflective of the strong underlying demand we see in the marketplace for our products. We were extremely pleased with the growth of our APTIMA franchise in the third quarter, and thus far, we're having an excellent October as well. We continue to follow a winning playbook with APTIMA. First, grow the market by leveraging our automated TIGRIS platform, and by facilitating and testing from new non-invasive sample types. Second, convert customers from the non-amplified PACE product line to APTIMA COMBO 2. And third, gain market share versus our competitors through our differentiated and unique product offering. To provide you a little more detail on the success of these strategies, let me mention that we added another dozen competitive accounts in the third quarter, an impressive performance against formidable competitors. It's interesting that the majority of these competitive wins came on our semi-automated DTS systems, not on our TIGRIS platform. At this point, we know…

Herm Rosenman

Analyst · Robert W. Baird Co. Sir, your line is open

Thank you, Carl, and good afternoon, everyone. As described in our press release, Gen-Probe had a very strong third quarter. Product sales grew 11% compared to the same period in 2007, despite a tough comp created by onetime instrument sales last year. Total revenues rose 19%, while earnings per share increased by 71%. Carl already covered the dynamics of product sales, so let me begin by discussing collaborative research revenues, which were $11.3 million for the third quarter of 2008, up significantly from $3.1 million a year ago. As most of you know, this increase resulted from the $10 million milestone we earned from Novartis related to the full US approval of ULTRIO on TIGRIS. As we said in our last call, we expect collaborative research revenues to average around $1 million a quarter going forward into 2009, given the reduced need for shared development projects in blood screening. Royalty and license revenues were $1.6 million in the third quarter of 2008, up 33% compared to the prior year period. Royalties from Chiron related to the use of our assays in the plasma screening market continued to be the largest component of this revenue line and increases in this area drove most of the year-over-year change. Now I'll turn to the expense items. As highlighted in our press release, we were very pleased with our gross margin performance in the third quarter. Gross margin on product sales was 71.7%, a very healthy increase compared to 67.3% in the prior year period. This improvement resulted primarily from a favorable product sales mix, namely increased sales of our blood screening products and APTIMA COMBO 2 assay, and reduced sales of lower margin instrumentation. Gross margins also benefited from favorable manufacturing variances that resulted from cost controls and volume leverage and obviously from…

Michael Watts

Analyst · Leerink Swann. Sir, your line is open

Thanks Herm. We're happy to take your questions now. For the Q&A, we're joined by Steve Kondor, our Senior Vice President of Sales and Marketing, as well as Kevin Herde, who's our 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. Mary, we're ready to take the first questions. Question and Answer

Operator

Operator

Thank you. We'll now begin the question and answer session. [Operator Instructions]. And our first question comes from Quintin Lai with Robert W. Baird Co. Sir, your line is open.

Quintin Lai

Analyst · Robert W. Baird Co. Sir, your line is open

Hi. Good afternoon. Congratulations on a nice quarter.

Henry L. Nordhoff

Analyst · Robert W. Baird Co. Sir, your line is open

Thank you, Quintin.

Quintin Lai

Analyst · Robert W. Baird Co. Sir, your line is open

A couple of questions, first on the share buyback. You bought back $10 million in the quarter. The guidance for the full year, I guess, doesn't seem to me, assuming any major share buybacks in the fourth quarter. Given the market conditions over the last little bit, why not relook at share buybacks I guess along with M&A, a little more aggressively?

Herm Rosenman

Analyst · Robert W. Baird Co. Sir, your line is open

Yes, hi. It's Herm, Quint. I think that we did say that we were going to be a little more aggressive as soon as the window opened. That window opens I believe on Tuesday morning. We'll take a look at it. Our share price was a lot lower just a few maybe hours, a few days ago. But we definitely are going to take a look at that. In addition, we do have in place a 10b5-1 plan, which we'll acquire if we don't in the open market at certain levels. But yes, I think you're absolutely right and that's what we're looking at seriously.

Quintin Lai

Analyst · Robert W. Baird Co. Sir, your line is open

And then with respect to the Chlamydia, gonorrhea market, you kind of made some mention that the overall market is a little bigger than you expected. What does that say about volume versus price or are prices stable? Are you seeing any kind of… any changes there? And then with respect to just general volume growth and then how do you kind of forecast the overall market, especially in the US here, for the next couple of years?

Stephen J. Kondor

Analyst · Robert W. Baird Co. Sir, your line is open

Quintin, this is Steve Kondor I'll answer that question. As you know, we commission a market research company to… on a quarterly basis do channel checks not only in the United States but overseas as well. And so they've characterized the market. It is growing a little bit more rapidly than they had anticipated in previous surveys and previous research, number one. Number two, despite the economic difficulties that we're having here in the United States across our customer segments and even outside the United States across all of our customer segments, we continue to see more CT/GC testing. ASP, your comment about ASP, we've seen… again, we've expected more declines in ASP with the result of competition coming in. We haven't seen that as aggressively as yet. So those are all factors that played into our performance.

Quintin Lai

Analyst · Robert W. Baird Co. Sir, your line is open

Okay. Thank you very much. Congratulations again.

Henry L. Nordhoff

Analyst · Robert W. Baird Co. Sir, your line is open

Thank you, Quintin.

Operator

Operator

And our next question comes from Bruce Cranna with Leerink Swann. Sir, your line is open.

Bruce Cranna

Analyst · Leerink Swann. Sir, your line is open

Thanks. Good afternoon, everyone.

Henry L. Nordhoff

Analyst · Leerink Swann. Sir, your line is open

Hi Bruce.

Bruce Cranna

Analyst · Leerink Swann. Sir, your line is open

I have to ask one guidance question, because I know someone else will if I don't. But if I do the math on the top of the range for EPS, I get kind of $0.37 for Q4. And I have to ask you, it just seems a little bit curious, so that would be really flat year-over-year, Q4 to Q4. And I guess I'm a little bit maybe skeptical that that's in fact a reasonable piece of guidance. Can you comment a little bit about if I look at marketing sales and G&A again on a year-over-year basis, it seems like there should be a little more leverage there in Q4.

Herm Rosenman

Analyst · Leerink Swann. Sir, your line is open

Well, there's a couple of things going on there, Bruce. One, we did mention that the shipments in the fourth quarter around the holiday season were likely to be similar to last year, so we probably see a little bit of revenue contraction there. We did mention of course relative to next year that FX would probably cost us a couple million bucks in blood screening, but it's probably going to cost us a little bit too, depending what happens with foreign exchange in the fourth quarter. We see so far that it's headed in the wrong direction. Also, our collaborative research revenue of course is going to be down considerably because we had the $10 million milestone, don't forget, in the third quarter.

Michael Watts

Analyst · Leerink Swann. Sir, your line is open

Yes, Bruce, it's Mike. I think in the fourth quarter of last year we did close to $5.5 million in collaborative research revenue versus guidance that we're giving this year, obviously at a much lower level. So I think that's a big part of what you're seeing.

Bruce Cranna

Analyst · Leerink Swann. Sir, your line is open

And just looking at G&A sequentially from 2Q, what is it that causes that to peel back so much? Can you quickly comment on that? Is that headcount reduction or something else we should be thinking of?

Herm Rosenman

Analyst · Leerink Swann. Sir, your line is open

No, from Q2 we had pretty heavy acquisition expenses on Innogenetics, and we had a little bit in Q3 as well. But Q2 was the heaviest quarter.

Bruce Cranna

Analyst · Leerink Swann. Sir, your line is open

Okay. And then just last for me on Millipore. I know you didn't talk a lot about it or if you talked about it at all, and I'm sure I can't pry a dollar amount out of you. But can you guys comment on the trend there, if there is a trend to comment on, and if not what seems to be the roadblock with that part of the business.

Henry L. Nordhoff

Analyst · Leerink Swann. Sir, your line is open

There really is no trend, Bruce. I wouldn't call it a roadblock. It's just taking a little bit longer than we had thought. It still is a priority both for ourselves and for our partners at… Bruce, you satisfied?

Bruce Cranna

Analyst · Leerink Swann. Sir, your line is open

Yes. I'm sorry, you cut out there. I lost you.

Henry L. Nordhoff

Analyst · Leerink Swann. Sir, your line is open

At what point did you lose me?

Bruce Cranna

Analyst · Leerink Swann. Sir, your line is open

Just when you started to talk. I'm sorry.

Henry L. Nordhoff

Analyst · Leerink Swann. Sir, your line is open

Before or after the 20 minute note? I will see if I remember what I said.

Bruce Cranna

Analyst · Leerink Swann. Sir, your line is open

I don't think that was…

Henry L. Nordhoff

Analyst · Leerink Swann. Sir, your line is open

There really is no trend that's apparent. It's just taking a little bit longer than both parties had anticipated. But it remains a priority item for both companies.

Bruce Cranna

Analyst · Leerink Swann. Sir, your line is open

All right, thanks.

Henry L. Nordhoff

Analyst · Leerink Swann. Sir, your line is open

So stay with us.

Bruce Cranna

Analyst · Leerink Swann. Sir, your line is open

Thank you.

Henry L. Nordhoff

Analyst · Leerink Swann. Sir, your line is open

Thank you, sir.

Operator

Operator

And your next question comes from Bill Quirk with Piper Jaffray. Sir, your line is open.

William Quirk

Analyst · Piper Jaffray. Sir, your line is open

Thanks. Good afternoon.

Henry L. Nordhoff

Analyst · Piper Jaffray. Sir, your line is open

Hi Bill.

William Quirk

Analyst · Piper Jaffray. Sir, your line is open

First up, Carl, understanding the sensitivity around the ULTRIO blood banking discussions. There obviously appears to be strong interest in the channel. Is price really the only roadblock to adoption here? I guess that's kind of what I heard. I just wanted to clarify.

Carl W. Hull

Analyst · Piper Jaffray. Sir, your line is open

Yes. As we look at it, Bill, we think that the ultimate pricing discussions are the pacing factors right now. I think from the data that we just summarized, you can see the utility. I think that's pretty well established and shouldn't be the issue. So got to get through the price hurdles and then that leads ultimately I think to the adoption curve.

William Quirk

Analyst · Piper Jaffray. Sir, your line is open

Okay. Understood. And then secondly, just considering your comment about continuing to look at deals and structure them either as potential geographic expansion or tuck-in deals, given the investment that you guys are making and obviously have planned, particularly in '09 to build out the EU team, should we be thinking about tuck-in more so than geographic expansion? And if so, should we be looking at this from an intellectual property perspective or reagent or assay perspective or would you actually look at instrument companies as well?

Henry L. Nordhoff

Analyst · Piper Jaffray. Sir, your line is open

Well, I'm not really sure what a tuck-in is comparing to one for geographic expansion. I think if we were to prioritize, Bill, our objectives, it would be to get some more activity, some more growth on the top line. And the two products that we're currently selling in Europe, HPV and PCA3 are doing well. And we are investing in people and getting a company with a nice infrastructure, it would be very good. If at the same time we can acquire some technology and some of the skill sets, I think that would be terrific, too. Would we consider an instrumentation company? We have looked at some in the past. And we see some utility from time-to-time. But I don't think we're close to moving that far afield from assays.

William Quirk

Analyst · Piper Jaffray. Sir, your line is open

Understood. So essentially, if I'm hearing you correctly, it's on the US side to be more focused on the menu and outside of the US, distribution plus potential menu?

Henry L. Nordhoff

Analyst · Piper Jaffray. Sir, your line is open

Yeah, I think that's true. And I think our focus would be outside the US rather than in the US right now because of the opportunities we have in Western Europe.

William Quirk

Analyst · Piper Jaffray. Sir, your line is open

Understood. Thanks very much for the color.

Henry L. Nordhoff

Analyst · Piper Jaffray. Sir, your line is open

You're welcome, Bill.

Operator

Operator

And your next question comes from Imron Zafar from Deutsche Bank. Sir, your line is open.

Imron Zafar

Analyst · Deutsche Bank. Sir, your line is open

Thanks and good afternoon.

Henry L. Nordhoff

Analyst · Deutsche Bank. Sir, your line is open

Good afternoon.

Imron Zafar

Analyst · Deutsche Bank. Sir, your line is open

Could you please talk about PCA3 sequential trends in Europe and also maybe give us a progress report on HPV, both commercially in Europe and then the clinical trial….

Henry L. Nordhoff

Analyst · Deutsche Bank. Sir, your line is open

Steve, can you comment?

Stephen J. Kondor

Analyst · Deutsche Bank. Sir, your line is open

Be happy to, Imron. First, PCA3. We're very pleased with the performance and the adoption of PCA3 in Europe, the CE product. We're able to market the product, as you know. Our business has increased fourfold since this time last year in terms of revenues, in terms of numbers of men that are being screened with PCA3 or tested for PCA3. But remember that's on a very small basis. But we're very, very pleased. In order of magnitude, the number of testing centers we had at this time last year in Europe was three. We now have 30 testing centers. So everything is moving very, very well in Europe and we're very pleased with that. With regard to the United States, you may know that… or may recall that we indicated that we'd be having a meeting with the FDA. We did that a couple of weeks ago and that meeting was very positive, very productive. No decisions have been made yet with regard to the current PCA3 ASR test in the United States in terms of moving to a clinical trial on that in the United States. But we'll continue to have discussions with the FDA, and of course you know we've announced before that we absolutely will have a US clinical trial for the PANTHER PCA3 product down the road. HPV, back to Europe, we have launched the product. We have a number of studies underway. We had the HPV conference, which is called Eurogen, in Nice, France in two weeks where we will show preliminary data of a very significant study that's going to be a multiyear study and that data will be presented. Thank you.

Imron Zafar

Analyst · Deutsche Bank. Sir, your line is open

Okay, great. And then for Herm, does updated guidance include any impact from the renewal of the R&D tax credit and, if so, can you quantify the contribution for that in the new guidance?

Herm Rosenman

Analyst · Deutsche Bank. Sir, your line is open

Yes, it does. And that will bring down probably less than a percentage point.

Imron Zafar

Analyst · Deutsche Bank. Sir, your line is open

Great. All right, thank you very much.

Henry L. Nordhoff

Analyst · Deutsche Bank. Sir, your line is open

Thank you.

Operator

Operator

And our next question comes from David Lewis with Morgan Stanley. Sir, your line is open.

David Lewis

Analyst · Morgan Stanley. Sir, your line is open

Good afternoon.

Henry L. Nordhoff

Analyst · Morgan Stanley. Sir, your line is open

Hi David.

David Lewis

Analyst · Morgan Stanley. Sir, your line is open

Herm, just starting with you on gross margins, they've been up sequentially on product sales throughout the year, which is nice to see. But given commentary that APTIMA is now 88% of the mix, I'm kind of wondering what factors can be positive or accretive to gross margin on a go-forward basis, either in the fourth quarter or heading into next year.

Herm Rosenman

Analyst · Morgan Stanley. Sir, your line is open

Well, it's primarily mix. We've talked about somewhat lower instrumentation. Part of that goes out at no profit at all. Our highest margin products continue to be our blood screening products and APTIMA COMBO 2 so additional growth there will give us higher margins because the same kinds of leverage we… operational leverage that we see by manufacturing more tests using the same capacity will continue to improve. That said, of course, we're kind of watching FX which has had… we've had pretty good results from that over the past three or four quarters and it appears that that might be going the other way. But to answer your question, it would be those factors.

David Lewis

Analyst · Morgan Stanley. Sir, your line is open

Okay. And then, Carl, obviously we're engaged in a high stakes game of Chicken here on ULTRIO, or at least it sounds. The one thing that is in your control besides price obviously would be the FDA mandate. So maybe give us some timing in terms of when do you think a range of FDA mandating ULTRIO was possible and then what can you do or what can Chiron do to help push the envelope there with the agency?

Carl W. Hull

Analyst · Morgan Stanley. Sir, your line is open

Well, David, I mean obviously that's us speculating about what the government will do. And given the events of the last couple of months, I'm pretty hesitant to do that. I think in practice it's a pretty straightforward process, as we understand it. The Blood Products Advisory Committee to the FDA is the organization that's responsible for evaluating both new technologies and/or threats to the blood supply and making recommendations as to how the industry should cope with that. Our view is that the FDA staff will, and is, frankly, evaluating what the role of HBV NAT screening should be in the US blood supply. They then make a recommendation to BPAC. BPAC in turn considers that and makes recommendations. The result of that recommendation process would be either a decision to do nothing or a guidance document that would recommend screening. We think that that could occur at any point in upcoming BPAC meetings practicality, I believe the only one that I know for sure that's scheduled is December, might be unlikely that it makes the agenda with a full scientific consideration by that time. But they tend to meet either three or four times a year. So I would expect that you could see some discussion of that formally by the regulatory bodies in the first half of next year.

David Lewis

Analyst · Morgan Stanley. Sir, your line is open

Okay, that's helpful. And then, Hank, one last question for you. Two comments on this call I think are somewhat interesting. One is we have ULTRIO approval so we're sort of T minus the five-year clock with our friends at Novartis. The second comment was one Hank made… I'm sorry, Herm made about falling collaborative research revenue, which is sort of a signal that maybe we don't have as many things to work on with our friends overseas. So those two data points say to me maybe it's time to fly across the Atlantic and talk to Novartis about a potential renegotiation of the contract. So can you kind of update us on that and do you share a similar opinion?

Henry L. Nordhoff

Analyst · Morgan Stanley. Sir, your line is open

You've given me a lot of options there, David. We have been engaged with Novartis in trying to come up with a mutually beneficial way to extend the agreement. And I think those tests or discussions are proceeding apace. I think that they will end up positively for both companies. But as our discussions and negotiations with Chiron on ULTRIO, I'd be really reluctant to say anything more specific than that tat this point, David.

David Lewis

Analyst · Morgan Stanley. Sir, your line is open

Okay. Thank you very much.

Henry L. Nordhoff

Analyst · Morgan Stanley. Sir, your line is open

Thank you.

Operator

Operator

And our next question comes from Jon Wood with Banc of America Securities. Sir, your line is open.

Jon Wood

Analyst · Banc of America Securities. Sir, your line is open

Hey, thanks. So, back on Novartis…

Henry L. Nordhoff

Analyst · Banc of America Securities. Sir, your line is open

Hi Jon.

Jon Wood

Analyst · Banc of America Securities. Sir, your line is open

Hey. Back on Novartis for a second, they recently created it looks like a standalone molecular diagnostics business within their oncology therapeutics business. I mean is there an opportunity to work with Gen-Probe, work with them. I'm not sure if they're just screening biomarkers or what, but is there an opportunity to potentially expand the collaboration to the cancer side there?

Henry L. Nordhoff

Analyst · Banc of America Securities. Sir, your line is open

I think there's always that opportunity. We've talked about personalized medicine and biomarkers over the years we've had our discussions. I wouldn't say it's a certainty, Jon, but it's certainly something that we would be interested in.

Jon Wood

Analyst · Banc of America Securities. Sir, your line is open

Okay. Thanks. And then, Herm, why would product gross margin decline sequentially? Is it just a lower volume… the holiday related lower volume? Can you give us some insight into that?

Herm Rosenman

Analyst · Banc of America Securities. Sir, your line is open

Are you talking about the fourth quarter?

Jon Wood

Analyst · Banc of America Securities. Sir, your line is open

Right, yes.

Herm Rosenman

Analyst · Banc of America Securities. Sir, your line is open

So in the fourth quarter we're going to see probably, my guess is the opposite effect from FX for one thing. Talked about shipment patterns as well. I think those two in combination will get you to that lower fourth quarter gross margin that's implied by the guidance.

Jon Wood

Analyst · Banc of America Securities. Sir, your line is open

Okay. And then the DSOs, I mean down eight days sequentially, is that sustainable at this level or is there the potential for that to tick back up sequentially in the fourth quarter?

Henry L. Nordhoff

Analyst · Banc of America Securities. Sir, your line is open

Kevin?

Kevin Herde

Analyst · Banc of America Securities. Sir, your line is open

Hey Jon. Kevin Herde. We had a… we had an excellent question [ph] period. We had a little bit of timing. We had some customers of ours pay a little early. Certainly 33 days is not a diagnostics question period so we're anticipating going forward we think certainly something around 40 is our target. And that still is much better than the industry average and probably where it will be sustainably going forward.

Henry L. Nordhoff

Analyst · Banc of America Securities. Sir, your line is open

We're going to try to reign in Kevin a little bit, try to soften him up a little bit with his tactics.

Jon Wood

Analyst · Banc of America Securities. Sir, your line is open

And then one last one. Hank, on the M&A situation, has there been a change in the pipeline over the last 60 days or is it too early, just from the dislocation in the equity markets, is it too early to tell perhaps if there's a few more opportunities to look at?

Henry L. Nordhoff

Analyst · Banc of America Securities. Sir, your line is open

I think there's a noticeable change in startup pharmaceutical companies. I think that the VCs have lost their appetite. I don't think they see an IPO as an exit strategy anymore and I think they're recognizing the risk of these long, long development timelines. But then the companies that we have been identifying and looking at, I haven't seen any change there.

Jon Wood

Analyst · Banc of America Securities. Sir, your line is open

Okay, thanks a lot.

Henry L. Nordhoff

Analyst · Banc of America Securities. Sir, your line is open

Thank you, sir.

Operator

Operator

And your next question comes from Patrick Donnelley with Thomas Weisel Partners [ph]. Sir, your line is open.

Patrick Donnelly

Analyst

Thanks. Just filling in for Peter Lawson tonight. How are you guys?

Henry L. Nordhoff

Analyst · Robert W. Baird Co. Sir, your line is open

Good, Patrick. How are you?

Patrick Donnelly

Analyst

Good, thank you. Just to build on Bill's question from earlier, can you go over the ability to grow internationally with and without acquisitions and how that has changed in these times now?

Henry L. Nordhoff

Analyst · Robert W. Baird Co. Sir, your line is open

I think about the only change, Patrick, has been our pricing with the ascension of the dollar. Whether that's going to be able to be sustained or not, I don't know. I think the metrics are still basically the same. We are investing in putting people in Europe and we're still looking at companies who can assist us in our marketing and sales effort. Carl, you want to add something?

Carl W. Hull

Analyst · Piper Jaffray. Sir, your line is open

Sure. I think, Patrick, the other thing we could highlight is that the growth rates for the European market when it comes to STD and the related testing of interest to us continue to be robust. They appear stronger than those in the US market, which, as we already covered, is going quite well as well. So we think it's a little bit under-penetrated in terms of the technology and the screening that's been done historically and that represents a good opportunity for us on a go-forward basis.

Patrick Donnelly

Analyst

All right, great. And I know you guys touched on it a few times, is there any way you can quantify the FX effects for next quarter you're expecting?

Henry L. Nordhoff

Analyst · Robert W. Baird Co. Sir, your line is open

If you could tell us what the exchange rate's going to be?

Herm Rosenman

Analyst · Robert W. Baird Co. Sir, your line is open

That would be great.

Patrick Donnelly

Analyst

But just with the guidance you gave, are you anticipating…

Herm Rosenman

Analyst · Robert W. Baird Co. Sir, your line is open

Are we anticipating?

Henry L. Nordhoff

Analyst · Robert W. Baird Co. Sir, your line is open

We're always pretty conservative, Patrick.

Patrick Donnelly

Analyst

Okay. All right, great. Thanks, guys.

Henry L. Nordhoff

Analyst · Robert W. Baird Co. Sir, your line is open

Thank you.

Operator

Operator

And our next question comes from Zarak Khurshid with Caris & Co. Sir, your line is open.

Zarak Khurshid

Analyst · Caris & Co. Sir, your line is open

Good afternoon, guys. Thanks for taking my questions.

Henry L. Nordhoff

Analyst · Caris & Co. Sir, your line is open

Welcome.

Zarak Khurshid

Analyst · Caris & Co. Sir, your line is open

All right. Just curious what happened with Qualigen to make you take that write-down?

Herm Rosenman

Analyst · Caris & Co. Sir, your line is open

Yes, it has to do with their business. Remember we made an investment of about $7 million in their business. That business is an immunoassay box, so to speak, and they sell all the consumables for PSA and testosterone. And they have continually, at least to this point, lost money and are burning cash at a rate where we had to do another valuation and that valuation turned up what we think is another temporary loss on the investment of about $1.6 million.

Zarak Khurshid

Analyst · Caris & Co. Sir, your line is open

Understood. And then as a follow-up, just curious if you could break out a little more color on the European clinical diagnostics business versus US, what you're seeing in terms of those different growth rates and so forth? Thank you.

Stephen J. Kondor

Analyst · Caris & Co. Sir, your line is open

Well, Zarak, this is Steve. Carl touched on it just a moment ago, but we do see an opportunity in terms of STDs. Our penetration in Europe or our market share in Europe is about 30%, 35% as opposed to 60% plus in the United States. So we had an opportunity there. And clearly in the future, with PANTHER coming out, we're very excited about the opportunity to penetrate on a more decentralized basis STD testing as compared to United States. Having said that, our growth is very good international, particularly Western Europe with regard to TIGRIS. We've added some more salespeople at the end of last year, beginning of this year and we're picking up a substantial amount of STD business in TIGRIS in Europe. So we're very pleased with that. Did that answer your question, sir?

Zarak Khurshid

Analyst · Caris & Co. Sir, your line is open

Yes, thank you.

Henry L. Nordhoff

Analyst · Caris & Co. Sir, your line is open

Thank you.

Michael Watts

Analyst · Caris & Co. Sir, your line is open

Mary, I think we might have time for one more, then we've got some brief closing remarks.

Operator

Operator

Okay, thank you. Our last question comes from Tycho Peterson with JPMorgan. Sir, your line is open.

Tycho Peterson

Analyst · JPMorgan. Sir, your line is open

Hey, good afternoon.

Henry L. Nordhoff

Analyst · JPMorgan. Sir, your line is open

Hi Tycho.

Tycho Peterson

Analyst · JPMorgan. Sir, your line is open

I'm wondering if you can comment a little bit more on some of the other pipeline initiatives. I appreciate the color you provided on the Millipore collaboration. But I guess maybe coming out of AABB there's a little bit of talk about dengue and ULTRIO Plus. If you can comment on maybe adding some of the other high risk subtypes there? And then also just a quick comment on MRSA in flu testing and whether there's any light at the end of the tunnel there?

Carl W. Hull

Analyst · JPMorgan. Sir, your line is open

Sure, Tycho, I'll take a shot at that. The activities we have underway include, I would say, a considerable amount of work where we look at emerging infectious diseases on our own and in collaboration with some of the customers that Novartis serves. And dengue clearly is high up on that list. Currently, as you may have seen at the AABB as well, there's great concern, particularly in Western Europe, about Chikungunya. So there is a couple of targets that are out there. It is something that we're pretty good at prototyping assays for and doing collaborations with people to establish the efficacy of not only the assays but the prevalence of the disease. And I think you should assume that that's an ongoing effort for us and we'll continue in the future.

Carl W. Hull

Analyst · JPMorgan. Sir, your line is open

I think as we think about other aspects of the blood bank business, right now we're in a pretty solid position having the automation and the fully approved screening products for the major infectious diseases that are routinely screened by molecular technology. So we feel pretty comfortable with that. As we think about MRSA, I would just tell you that we're at a stage now where we're completing a reexamination of both the markets and the technologies post the termination of our relationship with 3M. We did a lot of work there to adapt our assays and our technologies to their instrument base. We're examining the performance of those technologies now on our own platforms and assessing the market and we'll probably complete that assessment over the course of the year.

Tycho Peterson

Analyst · JPMorgan. Sir, your line is open

Okay. And then any… is food kind of off the table now or any hope there?

Henry L. Nordhoff

Analyst · JPMorgan. Sir, your line is open

Oh, it is. Food is still on the table, Tycho. See really a terrific opportunity. We're just not quite sure how to approach it. So we're still investigating it.

Tycho Peterson

Analyst · JPMorgan. Sir, your line is open

Okay. And then to just kind of get a little bit more granular on the guidance you've given in terms of the work-down of West Nile from Novartis, did you imply that that was mostly going to be in the fourth quarter or is that going to trickle out over a couple of quarters?

Herm Rosenman

Analyst · JPMorgan. Sir, your line is open

That'll probably trickle out over several quarters and then we put a couple of million bucks potentially on that.

Tycho Peterson

Analyst · JPMorgan. Sir, your line is open

Okay. And then just to thinking about the infrastructure build-out in Europe, I mean appreciate the color you've given for the year, for next year. But should we assume that that's going to be front-end loaded or is that going to be a pretty smooth build-out throughout the year?

Stephen J. Kondor

Analyst · JPMorgan. Sir, your line is open

Tycho, this is Steve. No, it's not going to be front-end loaded. It's going to be paced throughout the year.

Tycho Peterson

Analyst · JPMorgan. Sir, your line is open

Okay.

Henry L. Nordhoff

Analyst · JPMorgan. Sir, your line is open

So it'll be strap [ph] operation really, almost a pay as you go.

Tycho Peterson

Analyst · JPMorgan. Sir, your line is open

Okay. And then just to clarify your comment on M&A, are you still seeing a pretty big valuation disconnect? Was that what you were implying in terms of what the sellers are looking for, looking for a premium to the price at the beginning of this year?

Henry L. Nordhoff

Analyst · JPMorgan. Sir, your line is open

We don't see any great buys out there right now, if that's what you mean. No great discounts. We're looking at quality companies and you have to pay for quality.

Tycho Peterson

Analyst · JPMorgan. Sir, your line is open

Okay, great. Thank you very much.

Henry L. Nordhoff

Analyst · JPMorgan. Sir, your line is open

Thanks Tycho, and thank you all for all your questions. To wrap up, Gen-Probe had a very good third quarter. We showed solid revenue growth in a difficult macroeconomic environment and demonstrated good bottom line leverage as well. As a result, we are again raising our annual financial guidance. Before we sign off, I'd like to make two administrative announcements. First, our prepared remarks will be posted on our website momentarily and we encourage you to refer to them if you missed a fact or number during the call. And second, we hope to see many of you at our annual analyst day next Friday morning, November 7th, here at our headquarters in San Diego. And if you need any encouragement to make the trip, it is currently 78 degrees under a cloudless sky. Thank you for your time and attention today and please contact us if you have any follow-up questions. And thanks Mary.

Operator

Operator

Thank you, sir. Have a good evening.

Henry L. Nordhoff

Analyst · Robert W. Baird Co. Sir, your line is open

Bye-bye.

Operator

Operator

Bye. .