GoPro, Inc. (GPRO) Q2 2008 Earnings Call Transcript
Published at 2008-08-01 17:00:00
Good afternoon, everyone. On behalf of our Management team, I am pleased to welcome you to this conference call to discuss our Second Quarter 2008 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.genp-robe.com. In our call today, Hank will first provide an overview of our quarterly revenue performance. Carl will cover some strategic and operational items. Then Herm will review quarterly expenses in our revised 2008 guidance. We'll take your questions before warping up in an hour. Immediately after that we will post our prepared remarks on our website for your convenience. 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, perceive, could, should and would. For example, statements concerning 2008 financial guidance, financial condition, regulatory approvals and time lines, possible or assumed future results of operations, growth opportunities, industry ranking and plans and objectives of Management are all forward-looking statements. These 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 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 will turn the call over to Hank Nordhoff, Gen-Probe's CEO. Henry L. Nordhoff: Thank you, Mike, and good afternoon, everyone. Let me begin with my conclusion. Gen-Probe had a terrific second quarter. Our stock price fluctuated given the various macro economic challenges that engulfed the financial markets, our business remained stout. We did what Gen-Probe has always done best, grow our businesses in a highly profitable fashion, generated a good deal of cash and advanced our pipeline. And we accomplished these goals while pursuing a potential acquisition in a disciplined and analytical manner. In the second quarter, we set new product sales records in both clinical diagnostics and blood screening, and we posted total revenues and earnings per share that were ahead of our internal expectations. As a result we are again raising our financial outlook for the year. In addition, we launched our APTIMA HPV assay in Europe; began to gain traction with our PROGENSA PCA3 test overseas; and had, what we believe, were good productive discussions with the US FDA about gaining a hepatitis B screening claim for our PROCLEIX ULTRIO assay. Carl will tell you more about these pipeline developments in a moment. But first let me highlight our key financial results in the second quarter. Product sales were $113.7 million, representing growth of 21%, compared to last year, and also rising on a sequential basis. This robust product sales growth enabled us to post total revenues of $119.8 million up 18% compared to the second quarter of last year. This was very profitable growth in the second quarter, despite a onetime R&D charge and Innogenetics related cost that Herm will discussed. We had a gross margin of 71.4% and an operating margin of 27.4%. On the bottom line we had a net after tax margin of 20.7% in the quarter; it is translated into a net income of $24.8 million and earnings per diluted share of $0.45. In all this, on a GAAP basis which further underscores what we consider our unique and highly leveragable business model. Obviously, net income and earnings per share were down compared to the second quarter of last year, because last year's second quarter benefited substantially from a onetime credit to income tax expense of about $8.7 million or $0.16 per share. This swamps, the small tax benefit we enjoyed this quarter, which totaled $1 million or $0.02 of earnings per share. To eliminate the effects of these benefits and see our true underlying profitability growth in the second quarter, I would call your attention to operating income and pretax income, both of which grew 33% compared to last year. Turning to the components of product sales, we achieved record results in both clinical diagnostics and blood screening. Clinical diagnostics sales were up to $57.2 million, 14% higher than in the prior year period, and an acceleration over the roughly 10% growth we saw on the fourth quarter of 2007, and the first quarter of 2008. We believe this level of growth is especially impressive because the second quarter of last year was a tough comparator with diagnostics sales exceeding $50 million for the first time. Our APTIMA franchise continues to drive clinical diagnostics growth in the second quarter, especially when combined with the benefits of our fully automated TIGRIS system. Clinical diagnostics customers have now installed roughly a 140 TIGRIS instruments around the world and sales of APTIMA assays on TIGRIS grew by about 35% compared to the prior year period. APTIMA also continues to gain market share, in fact we added approximately a dozen accounts from competitors in the second quarter alone. In addition, within the Gen-Probe product family customers continue to upgrade to APTIMA from PACE, sales for which were down 22% compared to last year as expected. Before I discuss blood screening, let me mention that our PROGENSA PCA3 assay also picked up steam in Europe during the second quarter, with sales of our CE marked product exceeding sales of our analyte specific reagents in the US for the first time. We are pleased with this dynamic, which we believe reflects the targeted sales and marketing programs we are implementing in Europe. In addition, we think sales have befitted from the two PCA3 articles published in the peer reviewed of Journal of Urology in April and May. There is a report on our ex-US trials in press in the European Journal of Urology. Now, let me turn to blood screening; our sales grew to $56.5 million, a very robust 29% increase compared to last year and our highest rate of growth since the first quarter of 2006. Sales were again strong across our product portfolio and across geographic areas. In United States we and our partners at Novartis continue to enjoy a leading market share. In the second quarter, domestic sales benefited from additional shipments of the PROCLEIX ULTRIO assay for a post-marketing yield studies, a large portion of which has been conducted in pools of eight for an individual donor testing. US sales were also helped by full commercial pricing of the West Nile virus assay on the TIGRIS. I should point out that going forward; this West Nile pricing benefit will annualized and we will therefore be faced with tougher comps beginning in the third quarter. Our business is growing steadily outside the United States as well, in large part due to the success of the ULTRIO assay on the TIGRIS system. In fact during the second quarter worldwide ULTRIO sales were basically equal to sales of our duplex assay for the first time. As a reminder, this international blood screening growth generally comes at a lower overall price point as we expand into the developing world but as the euro and other foreign currencies have strengthened international sales have boosted our dollar denominated growth. We estimate that compared to the second quarter of last year foreign exchange fluctuations added about $1.9 million to blood screening sales. In addition, blood screening sales benefited from a $2.6 million one-time adjustment to service costs that Novartis had previously deducted under our collaboration, even excluding this benefits and the foreign exchange gains, blood screening sales would have increased by 19%, so an excellent performance. Before I move on, I should mention that blood screening sales included about 4.1 million of TIGRIS related revenues. This was down slightly compared to the prior period as expected. For the rest of 2008 we expect this downward trend to continue, but TIGRIS sales in Novartis are declining rather sharply given their healthy first half quarters and dampening overall blood screening growth in the process. Now, let me turn to collaborative research revenues, which were $4.7 million for the second quarter of 2008, down from $5.8 million a year ago. The decline resulted primarily from non-recurring revenue in the prior period. Specifically, last year's results included $2.4 million of reimbursement from Novartis that trued-up some past development expenses, as well as $1.4 million of funding from the Department of Defense for prostate cancer research. Neither item recurred in the second quarter of 2008. On the other hand collaborative research revenues benefited from onetime milestone revenue associated with the termination of our 3M collaboration. As a reminder we earned a $3 million milestone from 3M in the fourth quarter of 2007 for successfully demonstrating technical feasibility of an MRSA assay. But because we had an ongoing relationship with 3M at the time, accounting rules dictate that we recognize a revenue ratably over our planned development period. It's a little ironic that once our collaboration was terminated and our ongoing development obligation along with it, we were obligated to record all the revenue that we previously deferred, this net amount was $2.7 million. With the termination of our 3M agreement, and the expected decline and reimbursement from the Novartis following the completion of our ULTRIO post marketing studies, that we reiterate that what we have said before that collaborative revenue, research revenues are likely to decline substantially in the future. In fact, as we look ahead to 2009 we currently anticipate collaborative research revenues to be around $5 million for the year. Royalty and licensee revenues were $1.5 million in the second quarter of 2008 compared to $1.6 million in 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 not much changed in the year-over-year numbers. That wraps up my review of a very strong financial performance in the second quarter. Now, let me turn the call over to Carl, who will update you on some operational and strategic initiatives. Carl W. Hull: Thanks very much Hank, and good afternoon, everyone. I would like to touch on two pipeline updates to begin with. First, we still expect to secure hepatitis B screening claim for our PROCLEIX ULTRIO assay at some point in the third quarter, as a reminder we filed a supplement to our biologics license application for this product in February. In the meantime, our post-marketing studies have continued to go well, both at the American Red Cross and non-Red Cross sites. And we think our interactions with the FDA have been productive. Please recognize however, that this potential regulatory approval like all others is inherently uncertain. Second, most of you probably saw that we launched our CE marked APTIMA HPV test in late May in Europe. The European HPV market is still smaller today, and a s a result we don't expect significant sales in the near term. But this is nonetheless an important product development milestone for the company. As national HPV testing guidelines are formalized, we expect the market to continue growing rapidly. And we believe we are well-positioned with our APTIMA assay on the TIGRIS system. Initial feedback from opinion leaders and customers is positive, and we have several studies underway to build early momentum. A promise of our APTIMA HPV test in Europe plus the early success of PROGENSA PCA3 and the continued growth of our STD franchise, are among the reasons we offered to acquire the Belgian diagnostics company, Innogenetics this quarter to further expand our European presence. As you know, we later withdrew our bid rather than get into an increasingly dilutive bidding by Solvay. As we said in our press release at the time, we felt our discipline analytical process resulted in a full and fair offer for Innogenetics and a higher bid therefore did not make financial sense for us. So we believe walking away was the right decision. At the same time however, we still have a strategic need to increase our presence in the European molecular diagnostics market. The European market is growing at roughly double the rate of the US market, and is expected to be roughly the same size by the year 2011, as evidence of this overall market growth, in the second quarter our own international clinical diagnostic sales increased by more than 35%. With this is mind many of you have asked what are plan B is for better penetrating Europe. Our plan really has two components; first, we will accelerate the process of building out our own commercial infrastructure, which began over a year ago. As a company we think we've always been good at maximizing the effectiveness of our sales force and this quarter's results demonstrated that once again. So we see a nice opportunity to extend some of these competencies to Europe. This will be a gradual process, as we want to be extremely mindful of expected return for every incremental dollar we invest. So in another way, we do not intend to go on a near term hiring spree and then hope the sales will follow. Instead we plan to invest behind discreet quantifiable opportunities to maximize near term returns. As we think about how this might play out through our income statement, our preliminary view is that next year's sales and marketing expense, as a percentage of total revenues, could increase by a 100 to 150 basis points above our current 2008 guidance. The second part of our plan is to remain vigilant for European tuck-in or other acquisition opportunities. Although nothing is imminent in this regard, we certainly have the ability to remain opportunistic. We have $1 billion of cash, no debt, and a business that generates roughly $10 million of operating cash a month. Before I turn the call over to Herm, let me summarize by saying that we remain excited about several near-term new product opportunities, namely ULTRIO in the United States, and PCA3 and HPV in Europe. And we have wheels in motion to attempt to maximize the value of all three. Now, I'll turn the call over to Herm.
Thank you, Carl, and good afternoon everyone. As described in our press release, Gen-Probe had a very strong second quarter. Product sales grew 21%, compared to the same period in 2007, despite a tough comp, and also increased on a sequential basis establishing another record. Total revenues rose 18%, and earnings exceeded our expectations at $0.45 per share. So, I would like to reiterate what Hank said about the large tax benefit in the second quarter of last year. Although the second quarter earnings per share decline compared to the prior year based on this tax benefit, operating income and pre tax income both increased by 33%, which we believe are better indicators of the underlying health of the business. Hank already covered the revenue line, so let me discuss the expenses items. Gross margin on product sales were 71.4% in the second quarter of 2008, a very healthy increase compared to 67.9% in the prior year period. This improvement resulted primarily from a favorable product sales mix and from favorable manufacturing variances that resulted from cost controls and volume leverages. In addition, gross margin benefited from the $2.6 million of additional revenue we received from Novartis, related to adjustments made previously deducted service costs, because this was pure profit, it increased our quarterly gross margin percentage by about 70 basis points. Even without this benefit however, we think that gross margin percentage of 70.7% represents a nice improvement over the prior year. Research and development expenses for the second quarter of 2008 were $29.4 million, up 18% compared to last year. Part of this increase was expected, and resulted from the ramp up of two key development projects, namely HPV and PANTHER. We also recorded a $3.5 million impairment charges related to our license agreement with Corixa. As a reminder we licensed a broad suite of intellectual property from Corixa in early 2005, the most visible piece of which related to a prostate cancer marker called AMACR. We capitalized our license payments to Corixa and have been amortizing them to R&D expense based on our intent to commercialize the AMACR marker. However, during the second quarter of 2008, we concluded that this capitalized asset was impaired, based on a number of factors, including our decision not to include AMACR in a combination prostate cancer product in the near-term. As a result, we wrote off the remaining balance. Shifting gears, marketing and sales expenses were $11.5 million in the second quarter of 2008, up 22% compared to the prior year. This increase resulted primarily from European market development efforts related to our PROGENSA PCA3 and APTIMA HPV assays. As Carl said, we believe these efforts are beginning to pay off, and we therefore intend to increase our European commercial investments going forward. General and administrative expenses were $13.7 million in the second quarter of 2008, up 13% compared to last year. This increase mainly resulted from approximately $1.5 million of one-time expenses associated with our effort to acquire Innogenetics. Turning to taxes, in the second quarter, we benefited from the completion of an IRS audit of our 2005 federal tax return. As a result of this audit, we were reversed reserves for a number of small items that totaled approximately a $1 million. As a result, our effective rate in the quarter was about 32%. All this nets out to a very strong quarter of net income and second quarter earnings per share of $0.45, which we are very pleased with. As discussed, earnings per share were down 10%, compared to the prior year period based on the $0.16 tax benefit from last year. If you strip out the tax benefits from both quarters we showed 33% growth in both operating income and pretax income. Before I get to our updated 2008 guidance, I want to acknowledge that there were a number of onetime items affecting our second quarter results, both positively and negatively, and all these factors are in our numbers in accordance with GAAP. On the positive side, these items included the $1.9 million foreign exchange benefit, the $2.6 million product sales adjustment from Chiron, the $2.7 million collaborative research revenue associated with the cancellation of our 3M agreement and the $1 million tax benefit. On the downside, we had the $3.5 million Corixa write-off and $1.5 million of Innogenetics expenses. In the midst of all these moving parts, I want everyone to clearly appreciate the underlying strength of our business in the quarter. So, I'm going to make things easy and do some math on your behalf. If you strip up all the items I just mentioned from the second quarter of 2008, and also remove the large tax benefit in the $2.4 million onetime Chiron reimbursement from our prior year results. Here is what you would get on an apples-to-apple basis; product sales of $109.2 million up 16%, total revenues of $112.6 million up 14%, and earnings per share of $0.40 up 29%. So even if you taka out all the one-time items, including some that were anticipated and already included in expectations, we still had a very good quarter. And that's one reason we are again raising our top and bottom line forecasts for the year. We now expect total revenues of $467 million to $472 million in 2008. This is based on product sales growth of around 15% faster growth than in 2007 and total revenue growth slightly above that pace based on total non-product revenue comfortably above $40 million this year. We do expect product sales growth to slow somewhat in the back-half of 2008, based primarily on lower instrument sales to Novartis, tougher comps created by the anniversary of West Nile Virus commercial pricing on TIGRIS, the absence of the one time blood screening revenue adjustments and an anticipated moderation in Novartis's ordering patterns due in part with the completion of the ULTRIO post-marketing studies. But we still expect solid double-digit product sales growth in the second half of the year. Based on our healthy gross margin performance in the second quarter, we are tightening our full year guidance upward to between 69% and 70% for the year. We estimate our gross margin percentage will be higher in the fourth quarter than in the third, based primarily on internal production schedules, and ongoing improvements in product sales mix. In terms of R&D, we now expect expenses ranging from 22% to 23% of total revenues, slightly lower than our prior percentage guidance due primarily to the increase in total revenues. We forecast that R&D expenses would be around $28 million in the third quarter. Our guidance for marketing and sales, and general and administrative expenses has not changed. We continue to expect marketing and sales expenses of 9% to 10% of total revenues and G&A expenses around 11% of revenues. We now expect the tax rate of approximately 34% for the full year and a share count of 55 million to 56 million. This leads to our increased 2008 earnings per share guidance of between $1.83 and $1.87 on a fully diluted basis. The midpoint of this range implies 17% earnings per share growth, compared to last year, which we think is a very healthy bottom-line growth rate and faster than our expected revenue growth. In terms of the third quarter, we expect product sales to decline sequentially, based primarily on the absence of the $2.6 million true-up from Novartis, the decline in instrument sales that Hank discussed, and Chiron's ordering patterns. On the other hand, we are hopeful that we will earn $10 million from Novartis upon full approval of the PROCLEIX ULTRIO assay on the TIGRIS system. If we do, we expect total revenues in the third quarter to be almost equal to the second quarter level. When you factor in the expense guidance I provided earlier, we see third quarter earnings per share that is also roughly equal to the second quarter level in the mid $0.40 range. So this summarizes the financial section of our call. In the second quarter we set new records for both clinical diagnostics and blood screening product sales, driving solid growth in total revenues, and we posted strong earnings with or without a number of one-time items. As a result, we are again raising our total revenue and earnings per share guidance for the year. We expect 2008 will be another very good year for Gen-Probe. Now, I'd like to turn the call back over to Mike.
Thanks Herm. We are happy to take your questions now. For Q&A we are joined by Dan Kacian, Executive Vice President and Chief Scientist, Bill Bowen, Senior Vice President and General Counsel and Kevin Herde, Corporate Controller. Steve Kondor is our Senior Vice President of Sales and Marketing. He is still at the AACC Meeting and therefore he couldn't join us. In order to ensure broader 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. Operator, we are ready to take the first question. Question and Answer
Our first question comes from Jon Wood with Banc of America Securities. Your line is open.
Thanks a lot. Hey, Herm, what are you earning on your… on an after tax basis from the cash balance?
You know, John, its probably… you can probably figure it out. We haven't gotten that granular, but we are primarily in tax-free munis, it's probably around 3%.
Okay. I calculated the incremental after-tax returns on your core business to be nearly 40%, even excluding the one-time benefits. Why isn't that capital better optimized through investment in say your own shares, given the favorable overcharge there? Henry L. Nordhoff: We are going to have that discussion at the next Board meeting.
Can you let us know when that is? Henry L. Nordhoff: I think the regularly scheduled meeting is in September and we'll probably have the discussion before that time.
Okay. Thanks. But Carl, one more follow-up. Have you ruled out an additional distribution arrangement within established diagnostic player to get to market in Europe, I mean I understand your comments you made de novo and then looking for additional transactions. But is that… have you completed ruled out an the arrangement similar to the bioMerieux, U type deal in Europe? Carl W. Hull: You know, Jon, I think we've been pretty thorough in evaluating the different options that we have and I wouldn't say that we ruled anything out of this point. This is a question, what's best long-term for us, and what's the best way to participate in what we see as a very attractively growing market. So, no answer on that one specific.
Okay. Thank you. Carl W. Hull: Thank you, Jon.
Our next question comes from Bill Quirk with Piper Jaffray. Your line is open, sir.
Hi! Good afternoon. Carl W. Hull: Hey, Bill.
First question is if we axe out the number of the one-time items in blood screening, it does look as though that the base PROCLEIX ULTRIO business are ticking up here in the past couple of quarters. And I am a little curious, if we take look at the guidance raised, generally speaking it covers the bids, I mean too much frozen matter, I guess I am trying to flush out here, you expect some type of reversal in terms of the underlying blood screening business or am I just doing the math wrong here?
I think we better did by a little more than the bid. So we have guidance by… if you take the midpoints more than the bid, but you know we also have those two one-time items, one for roughly $2 million, $1.9 million, don't know if that's going to recur. Depends a lot on the euro-dollar, equation. And we also had the $2.6 million, we are pretty certain will not recur anywhere near that level. Although, some of the deductions will change as a result of that. Ordering patterns have been erratic with Novartis. We see no reason to believe that the underlying business is going to change substantially from where we are now.
Okay. And Herm, may be just asking a question slightly different way. What euro-dollar exchange rate are you assuming in this guidance?
Well, it's each month Bill, it's as they make the remittance to us of the actual consumption in the field. Henry L. Nordhoff: Hey, Bill, it's Hank, just to add to that a little bit, don't forget a couple of things that were affecting the first quarter results not favorably one is the some additional product that we shift for the yields studies for all three that are going on. As you know, portion of those yields studies were done either in IDT or in pools of eight, so obviously you are shipping more test. That study, hopefully, will conclude here in the second half of the year. And don't also forget something that happened in the first quarter, which was some early shipments of West Nile to prepare for what was anticipated to be a heavy season, as well as potentially different IDT triggers effects.
All right. Fair enough. And just staying on the same topic, Carl just wanted to make sure there wasn't something more ominous in your comment that you expect the full ULTRIO approvals sometime in the third quarter? I assume that nothing has changed with FDA, where things are progressing, I assume you probably haven't had labeling discussion… final labeling discussions yet but. Carl W. Hull: We can't comment on that Bill, but things are going as expected.
And so no… should read anything into the words sometime? Carl W. Hull: Nothing ominous naturally is the word. Carl W. Hull: Perfect. Thanks guys. Carl W. Hull: You got it.
Our next question comes from Quintin Lai with Robert W. Baird.
Hi. Good afternoon. Congratulations on a nice quarter. Henry L. Nordhoff: Thanks.
Diving a little bit again into the international sales, you said that worldwide ULTRIO now is exceeding PROCLEIX or the duplex test. Is that just from new volume or are you seeing convergence from duplex to ULTRIO also internationally and subsequently getting a price bump on that? Henry L. Nordhoff: Yeah Quintin we intended to say that the sales of the two products equalized for the first time in the past quarter outside of the United States. And we think both of the factors you site are going on. We are getting a new business and we are seeing convergence which we hope would be long-term from duplex, ULTRIO.
As they have migrated to ULTRIO, have they changed some of their pooling sizes to go to small pool… to smaller pools? Carl W. Hull: Yeah, I think, Quintin, that the dynamic that we've always highlighted outside the United States is that on average, those pool sizes are smaller to begin with. So, I do… I wouldn't say that the conversion is necessary associated with an acceleration of that rate of change. They're going to be smaller. And as Hank indicated in the comments, the AUP in the developing countries tends to be a bit lower than we've experienced in the west.
And then second question and I'll jump back into the queue. The write-down for Corixa is that just a function of you taking it out of immediate development or is that more of a comment on how you feel about AMACR? Henry L. Nordhoff: Ken, I think as Herm said, Quintin, in his comments, we had anticipated using AMACR in a combination with PCA3. We looked at it. It added very, very little in terms of specificity and really complicated an already fairly complex assay. The other potential biomarkers look really interesting. Pretty early on and we've done a lot of work on it. We don't really see anything that that really stands out that's giving value. So, we thought we'd be conservative and take the right path. And that's writing it off. That doesn't mean we're going ignore it. Our work is still continuing in trying to evaluate some of the biomarkers in the area of bladder cancer, prostate cancer and colorectal.
Thanks, Henry. Henry L. Nordhoff: You're welcome.
Our next question comes from Bruce Cranna with Leerink Swann. Your line is open.
Hi. Good afternoon. Henry L. Nordhoff: Hi, Bruce. Carl W. Hull: Hi, Bruce.
I just want to follow-up on Bill's question, a little bit on the blood screening side, because I pull out some of the one-time pieces and I still… you still get sort of 20% number year-over-year on the base business. So, maybe it'd be somewhat helpful if you guys could be coming a little bit about market growth rates. I assume that hasn't changed too much. But how much of that… let's say, 20% or so, organic rate of growth, maybe how much of that is pricing and then maybe talk a little bit about volume and mix. Carl W. Hull: Yeah, Bruce, it's Carl. I think that as we look at it, the overall donation trends globally haven't changed very much, they're low single-digit growers and there is nothing out there that shows that that's changed significantly. So, I think what you will have to be looking at is better success in two areas for us. One is the market share in those places that have already adopted molecular screening. And then continued success by our partners and Novartis in penetrating countries that haven't been using molecular methods up until now. I think those are the two major drivers I would see at the topline. Herm, don't know if you want to add some color there.
Yeah, I think that's right, Carl. And I'll just, Bruce, Mike talked about the West Nile Virus in the first quarter. So, to a large extent, we see a little bit of tail off there, because there was a little bit of stocking up, but other than that, I think it's exactly… Carl about, which is better penetration by Novartis.
Okay. So, may be a little forward buying in the quarter, Herm, is that what you are saying?
I am sorry, Bruce. Could you repeat it?
May be a little forward buying in this quarter? In other words, in the second quarter, you talked about…
No, Bruce, no. In the first quarter.
In what… in the quarter, you just printed, yeah. Henry L. Nordhoff: Yeah, and quite honestly, Bruce, it goes up and down. I think if you take everything out, the year growth quarter-to-quarter is about 19%. And that's probably a little high. We think it might be a little bit lower.
But just to clarify, I think what you termed forward buying was a issue that we think benefited us about in the first quarter, not in the second quarter.
I said you… okay. That was what I was getting at. So, you think there was nothing unusual in the channel this quarter? Henry L. Nordhoff: Yeah. Henry L. Nordhoff: That is always moving up and down, but nothing that we saw that was unusual.
Okay. And then just so I understand, the Corixa situation, the write-down was just on the AMACR property. Is that correct? Henry L. Nordhoff: No, it was the entire portfolio.
Okay, so the whole thing. So, nothing remains capitalized then, Hank? Henry L. Nordhoff: That's correct.
Okay. Thank you. Henry L. Nordhoff: You're welcome.
Our next question comes from Imron Zafar with Deutsche Bank. Your line is open, sir.
Hi. Good afternoon. Thanks for taking my questions. Henry L. Nordhoff: Hi, Imron.
Follow-up to Bruce's question from earlier, could you sort of talk about the clinical diagnostic segment as well in terms of what drove the upside? Was it market share gains or just better than expected end market growth? Carl W. Hull: Yeah, Imron, it's Carl. We think that we have seen, as Hank mentioned, competitive takeaways which aren't helpful on the diagnostic side. I think the performance of the assays along with the strength of TIGRIS continue to be the two key factors that we see driving our performance at least in terms of market share needs. I think secondly, you've seen that there is continuing concern from a public health point of view the rate at which these infections are spreading and groups based on age, for example, where they are saying a higher degree of frequency than they had expected previously. So, we think that those factors caused our major customers who are actually delivering these tests to see their markets expand. And I think if you would look at some of the results reported by the major lab companies, they continue to highlight their success in the esoteric areas where our molecular testing falls.
Okay. And then maybe just moving to the pipeline a little bit, can you just talk about the US HPV trial? Is enrollment going as expected? And then also on the hospital-acquired infections project and then the food testing project, are those projects being sort of deemphasized in terms of your R&D spend? How should we think about those in terms of timelines? Carl W. Hull: Let me try to remember all those questions. HPV US trials are starting. The pace is quickening. We're up to kind of a slower start. It's picking up now, and we expect to be where we expected to be early on by the end of this year. On MRSA, we haven't completed our analysis of that. We actually… they, 3M, pulled out of the relationship, the collaboration. One of the problem is that the system didn't work. We got the feasibility milestone for the assay, and there were some problems with the instrument. We are looking at that. Our analysis hasn't been… isn't completed yet. And on the food side, we have had a number of discussions with potential collaborators in terms of the selling side, and we had discussions with the FDA too on their process for utilization of the assays as well as the instrument. And those are ongoing, nothing really new or pivotal to report since the last time.
Okay. And then a very quick question for you, Herm. Can you just quantify what the expenses were related to the Innogenetics acquisition attempt on the G&A line?
Yeah, I can. In the quarter, we had roughly $1.5 million of expense related to that.
Great. Thank you very much, and congratulations on a great quarter. Henry L. Nordhoff: Thank you, sir. Carl W. Hull: Thanks.
Our next question comes from David Lewis with Morgan Stanley. Your line is open, sir.
Good afternoon. Carl W. Hull: Hey, David. Henry L. Nordhoff: Good afternoon, David.
Congratulations on the quarter. Mike told me at AACC there was something biting him back in the water out by the [indiscernible]. So, I guess that worked. Henry L. Nordhoff: Thanks, David.
Just a couple of quick ones here. I guess, first just a macro question. In the quarter, the clinical labs talked about [inaudible] weaker broadly, clearly your numbers didn't suggest… but it seems perhaps this week you have been doing a lot of garnering, so many testings off the vial any slowdown you see in sort of the July month as it relates to sort of essence your testings specifically in [inaudible] health or GC?
We are covering the second quarter, David.
Any weakness you saw on the second quarter. Carl W. Hull: No, we haven't seen a weakness on the second quarter. We are seeing a lot of competitive takeaways and that's pretty encouraging for us.
Okay. And so, (inaudible) and I am absolutely support incrementally in international markets. But can you just update us right now, from a business perspective, what percent of revenues comes ex-US in the blood screening, and diagnosis business? Henry L. Nordhoff: Well, I don't know what level of granularity we go to here, I think we have said previously about 21% to 22% of our total revenues are ex-US and I am looking at my colleagues and see if… Carl W. Hull: David, give us just a second.
I think, it increased a little in the second quarter, its… about 25% is ex-US. And that's covering both sides of the business. Obviously blood screening is much higher than that, probably close to, less than 50% but close to it. Carl W. Hull: Yes, exactly. It is in the neighborhood of 60-40, Dave.
Okay, perfect. That's very helpful. So what would make you to call Hank, what would make you happy in terms of a mix of international business, our non-US business over the next two to three years? What does that 25% need to be, if you just sort of executed on this international front?. Carl W. Hull: I would like to see something close to 50-50, David. I recognize it's going to take some time to do that. And I think the reason it's going to take some time is the [inaudible] real effect, that they do screening in this country, they are starting to do it in Europe, it's moved down from Scandinavia, but it's moving but it has got a long way to go
Okay. And then just one last one here. Carl, what number of people do we have on the ground internationally today? Carl W. Hull: We haven't gone in the specifics of the total number. I think we've said historically fewer than 20, just around the 20 number devoted to the international business. Couple of those headcount might be based here, but the vast majority of those are on the ground right now, and we are in the process kind of formulating the specifics of these expansion plan that we alluded to as we talked about what the potential spend could be next year.
Okay. Would it surprise you by the end of '09 if that number tripled? Carl W. Hull: Triple? It would surprise me. It will increase substantially David, but it's not going to triple.
Okay. Thank you very much. Nice quarter.
Our next question comes from Tycho Peterson with JPMorgan. Your line is open, sir.
Hey, good afternoon, and my congrats as well. Carl W. Hull: Thank you, Tycho.
Following up I guess just Dave's earlier question about the [inaudible], can you just give us a sense for the STD testing where are some of those competitive wins are coming geographically, is it out of Europe mainly or if you can give us a little bit more color as to where you are seeing some progress that would be helpful? Carl W. Hull: Well I think the majority of our competitive takeaways still remain in the United States. We are not steep I'm a little bit hypertense or exactly what the geographic split is, so I'd say we still think the majority is here in the US. Tycho.
Okay. Carl W. Hull: And I think one of the business in Europe is new business there.
Okay. And then Herm, you had a comment about manufacturing cost controls in your prepared comments, can you just elaborate a little bit on what are those and tell then whether there is a broader effort here on just manufacturing efficiency, and how you think about that?
No, Tycho, I don't think it's a broader effort. We're continually focusing on our all of our costs including manufacturing cost, our new SVP Operations, Jorgine Ellerbrock, Ellerbrock has been concentrating on that and we have home those down a little bit. And we also said, it was in addition to the manufacturing cost also volume leverage and it was principally volume leverage.
Tycho, it's Mike. Don't forget that one of the things that did affect the gross margin favorably in this quarter was the adjustments to the service deductions that we got from Chiron that was 2.6, I think was million, or something like that. That's pure margin, so it uses the number a bit.
Okay. Fair enough. And then just one last on the instrument development, if you could just give us quick update on PANTHER and, is CUDA still in the mix here, how do we think about that as well?
Yeah. We are proceeding a PACE with PANTHER. It's focus of our development efforts and as we indicated part of the ongoing spend that we have in the R&D program. The programs on track with its various milestones having cleared, its first development phase gained as previously talked about and are on track to have instruments in our hands and available for our assay scientist to work with. So we feel pretty good about how it's going CUDA a developments where we are continuing to make progress there, but it's no where near the same scale as the PANTHER investment.
Okay. Thank you very much.
Our next question comes from the Peter Lawson with Thomas Weisel Partners. Your line is open, sir.
Congratulations on the strong quarter and just on the back lag, could you just talk through the traction of PCA3 in Europe and where it's been use? What kind of hospitals are picking up? Henry L. Nordhoff: I was over there about three ago, Peter, specifically to look at the potential for PCA3 and HPV, I was very impressed. I met with a number of key opinion leaders, met with some customers, met some with some researchers, even the fact that may have been handpick, because we are all very positive and they were indeed positive and I'm very optimistic. We've got great growth now. I think the, in the second quarter PCA3 sales in Europe was basically the same as they are in US. Given the difference that we can market over there, we can't market it here. I'm very optimistic that we can do some good things.
And then was there any effects, benefit in the clinical diagnostics business?
Not worth talking about, Very, very small.
Our next question comes from Sara Michelmore with Cowen. Your line is open.
Hey good evening. Henry L. Nordhoff: Hey Sara.
So much for wanting a follow-up, let me see what's left here.
You would be the first one to follow the rules, Sara.
I believe Peter did great before me, but he was the only one. I'll have a couple of follow-up pipeline questions here, any thoughts about the clinical development pathway for PCA3 in the US? I know you talked about an assay reformat and maybe thinking about a clinical trial design, there at some point in near future, that would be helpful. And then in terms of the MRSA program and hospital acquired infections in general, what's the plan there going forward? You've got a little bit of work you've done here and is that something you're interested in pursuing either yourselves, or with another partner? Thanks. Carl W. Hull: On the PCA3 Sara, we have gotten a lot of encouragement from some of our investigators at Hopkins and [inaudible] saying that there has been an awful lot of data in the studies that they've been doing, and they tried to initiate the dialogue with the FDA and see if some of that can be used, not as pivotal studies, but as anecdotal information. And we are trying to do that. If we can get the existing formulation registered, approved in a shorter period of time than we had expected with lower money, we'll probably do that. On the HAI, we are looking at it. We just haven't finished our analysis yet. The market is in a state of flux, we don't know how much of the testing will be very, very quick testing and on the side of the hospital how much will be 4 hour to 5 hour results in our lab nearby. The test look pretty good, but we've got ways to go before. We are in a position to make independent decision on it.
Okay. Strategically does the low volume molecular platform interest you either a partnership or something that you may want to pursue internally or acquire externally? Carl W. Hull: If they were very small and expensive, it could possible both for the industrial market as well as for near-patient testing.
Thank you. Carl W. Hull: Welcome.
Our next question comes from Bruce Jackson with RBC Capital Markets. Your line is open, sir.
Good afternoon, congratulations.
Talking a little bit more about the MRSA testing, can you tell us just a little about the development work that actually took place, and was is it on one of your existing platforms with your existing chemistry what I am trying to get out is that going to speed up the development of that test? Carl W. Hull: As I recall it was basically an off the shelf type of instrument, some of the work was done on the instrument that 3M was developing. I don't think it's going to give us much an advantage in terms of speed.
Okay. And then with PCA3, it sounds like you are happy with the performance of that market, but just looking at possibly teaming it up with some other biomarkers. Do you have any ideas of how many markers it would take do you have any of these other markers identified? Carl W. Hull: Our initial approach was to do that. I think our current thinking is to teaming up with the other marker but not in a same assay. PCA3, it seems to do exceedingly well both from an early detections, so even on the diagnostic standpoint. That the play now is to use PCA3 for early diagnosis and then to develop tempus the gene infusion for diagnosis to tell you how severe, how aggressive is the cancer and what you have to do to deal with it.
Okay, great. And one last question on PANTHER, what's the next milestone that we should be looking for? Henry L. Nordhoff: Bruce, we have talked now about the recede of the prototype instruments and the expansion of our capability to do assay development on those here in-house, but I think we've disclosed dates publicly, but they are in the coming quarter.
All right. Thank you very much. Henry L. Nordhoff: Thank you.
The last question comes from Zarak Khurshid with Caris & Company. Your line is open, sir.
Yeah. Caris & Company. Thanks guys for taking my questions. I guess get back into it, but do you have rough estimate for the growth of the molecular clinical diagnostic in Europe? And then as the follow-up, when exactly does those marketing study wrap up, and then could you just describe the mechanics of kind of that effect pricing and volume when it does indeed close? Thank you. Henry L. Nordhoff: Zarak, let me take the first part of that, at least related to growth rates in the Europe. Obviously there are a lot of different estimates out there for molecular testing in Europe. I think that most that I've seen have been in the high teens to low twenties kind of percent growth rate versus maybe a 12% to 14% growth in the United States. Obviously our growth in the quarter was higher than that, that's off a small base. Carl W. Hull: Yeah, Zarak. It's Carl on the latter part of your question with respect to the post-approval marketing studies on HPV ULTRIO. Those will continue, first of all, obviously the claim has not yet been approved by the FDA and we have large customers utilizing this under clinical protocol. You would see us reduce the intensity of our efforts there. We don't feel we need to do to… any longer do detail patient follow-up for the clinical trial purposes. They are just being used as part of their standard operating procedures today. At the point of product is approved and that an account has decided to convert to maybe on a clinical trial at that point the clinical trial would formally end.
Thank you. Henry L. Nordhoff: Thank you, Zarak. Tracy we are going to wrap up now, and thank you all for your question. Gen-Probe had an excellent second quarter. We established new records for clinical diagnostics and blood screening product sales and shown good bottom line leverages as well. As a result, we are again raising our 2008 guidance for both total revenues and earnings per share. Now last few months, we also took important steps to generate future growth from our PROCLEIX ULTRIO assay in the United States and from our PROGENSA PCA3 and APTIMA HPV test in Europe. Thanks so much for your time and attention today and as the administrative reminder, our prepared remarks will be posted on our website almost within the moment. And we encourage you to contact us if you have any follow-up questions.
This concludes today's conference. You may disconnect at this time.