Hologic, Inc. (HOLX) Q3 2007 Earnings Call Transcript
Published at 2007-10-30 23:08:36
Henry Nordhoff - Chairman, President and CEO Herm Rosenman - VP of Finance and CFO Michael Watts - Senior Director of Investor Relations and Corporate Communications Bill Bowen - Senior VP and General Counsel Steve Kondor - Senior VP of Sales and Marketing Lynda Merrill - VP of Industrial Relationships Harry Rittenhouse - Senior Director of Cancer Research Carl Hull - EVP and COO Kevin Heardy - Senior Director of Finance
Matthew Notarianni - Robert W. Baird Jon Wood - Banc of America Securities David Lewis - Morgan Stanley Bruce Cranna - Leerink Swann Bill Quirk - Piper Jaffray Tycho Peterson - J.P. Morgan Peter Lawson - Thomas Weisel Partners Spencer Nam - Summer Street Research Partners Zarak Khurshid - Caris & Company Michelle Ha - Ferris, Baker Watts, Inc.
Excuse me, this is the conference coordinator. I’d like to thank everyone for holding for today’s conference call. At this time, all lines have been placed on a listen-only mode until the question and answer session of today’s conference. Also, the conference call is being recorded; if you have any objections you may disconnect at this time. Now at this time I’d like to turn the conference call over to your speaker, Mr. Mike Watts. Thank you sir, you may begin.
Thank you Barry, and good afternoon everyone. On behalf of Hank Nordhoff, Gen-Probe’s Chairman, President and CEO, and Herm Rosenman, our Senior Vice President of Finance and CFO, as well as the rest of the Gen-Probe team, I’m pleased to welcome you to this conference call to discuss our Q3 2007 financial results. The press release announcing our results was issued today just after 4:00 pm ET, and is posted on our website at www.gen-probe.com. In our call today, Hank will first provide an overview of our top-line performance in the quarter. Herm will then review our detailed results and updated guidance, then will take your questions. Before we begin, let me first review our safe harbor policy. Forward-looking guidance, financial or otherwise, is only provided on conference calls or in our press releases. Any statements in this conference call about our expectations, beliefs, plans, objectives, assumptions, or future events or performance, are not historical facts, and are forward-looking statements. These statements are often, but not always, made 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 2007 financial guidance, financial condition, regulatory approvals and timelines, possible or assumed results of operations, growth opportunities, industry ranking, plans, and objectives of management, are all forward-looking statements. Forward-looking statements are not guarantees of performance, they involve known and unknown risks and uncertainties that may cause actual results to differ materially from those expressed or implied. Factors that might cause such differences include, but aren’t limited to, those discussed in our SEC filings, including our report on Form 10-K, for the year ending December 31, 2006, and all subsequent periodic reports. Copies are available on our website, at www.sec.gov, and on request from our IR 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.
Thanks Mike, and good afternoon everyone. As described in our press release, Gen-Probe had a very good Q3. We set new records in both clinical diagnostics and blood screening product sales, as well as total revenues. As a result, we are again raising our 2007 financial guidance for revenues and earnings per share. Before I begin the discussion, I’d like to thank you for your many calls and concern surrounding the recent wildfires in San Diego. The fires were certainly frightening for hundreds of Gen-Probe employees, including several executives on this call, who were forced to evacuate their homes. In fact, we converted the training facility at our main headquarters campus, which was not in a fire zone, into a home away from home for about 60 employees and family members for a couple of nights. Thankfully, and in contrast to the fires four years ago, no employees lost their homes. As for the business, we do not expect any lasting disruption or negative financial effect from the fires. Our blood screening manufacturing plant in the town of Rancho Bernardo was closed for a few days last week, but we resumed full operations yesterday, and expect to be able to catch up on our productions and shipments over the next several weeks. Now let me review our record Q3 results. When I’m finished, I’ll bring you up to speed on one of our key R&D programs, our initiative to develop a test for human papillomavirus, or HPV, and also provide brief updates on our prostate cancer and Millipore initiatives. Product sales in Q3 were $97.4 million, another quarterly record, and 17% above last year. Non-product revenues were also healthy, contributing to record total revenues of $101.7 million. Total revenues were up 10% over Q3 2006, even though last year’s results included a $5 million payment from Bayer, in partial settlement of our patent infringement litigation. On the bottom line, net income was $17.3 million in Q3, an increase of 17%, despite a planned spike in R&D spending related to our HPV program. This translated into earnings per diluted share of $0.31, representing 11% growth over last year and ahead of expectations. If you examine the components of product sales, you’ll see that clinical diagnostics turned in another strong performance, with record sales of $51.8 million, up 20% compared to Q3 2006. Our APTIMA franchise for Chlamydia and gonorrhoeae testing once again led the charge, based on superior, well-validated product performance, and the unique automation and throughput offered by the TIGRIS instrument. We believe customers continue to value the unique combination of superior chemistry and engineering that we offer as evidenced by the market share we gain on a monthly basis. APTIMA sales also continue to grow strongly outside the Unites States, through our distributors, but more importantly through our own, growing, direct sales efforts. International sales represented less than 10% of total APTIMA revenue in the quarter, but we believe the opportunity for growth is substantial. We expect this to be an area of future investment for the company, especially since incremental sales and marketing resources could also support our PCA3 and HPV products in Europe. More on that in a moment. We can continue to execute well on our strategy to convert customers using PACE, our older, non-amplified test for chlamydia and gonorrhoeae, to our APTIMA product line. Base sales were down 29% in the quarter, in line with our expectations. Although the PACE franchise continues to erode in dollars, these products still represented nearly 40% of our STD unit volume in Q3, which means we should still have good opportunities to convert customers to APTIMA, at a higher selling price. Before I shift to blood screening, I should emphasize that clinical diagnostics sales were unusually high in the quarter, due to one-time sales of instruments, mainly TIGRIS, to both current and new customers. We estimate that compared to the average of recent quarters, these non-recurring sales added about $3 million of net incremental revenue, although like all instrumental sales, they were recorded at a very low margin. Most of these sales were made to current customers, so they won’t translate into additional revenue, as would new account conversions. However, we do believe customers who make the capital investment to own our instruments are even more loyal over the long term. Now for blood screening. Q3 sales were $45.6 million, a very solid increase of 13% versus the prior year period. This growth was driven by international expansion and by the first full quarter of commercial pricing for our PROCLEIX West Nile virus assay on the TIGRIS system. As a reminder TIGRIS was built for the West Nile virus testing in March, and we began recognizing commercial revenue in June, following a roughly two month contract conversion period, and the normal two month revenue recognition lag we have with Novartis. Our blood screening business continues to grow steadily outside the U.S. as well, albeit at generally low price points, as we penetrate the developing world, as we have pointed out previously. In the last several months, Novartis has begun selling the ULTRIO assay in Hong Kong and Switzerland, where customers continue to be attracted to the automation, throughput, and process controls offered by our unique TIGRIS instrument. In fact, TIGRIS sales to Novartis were about $3.2 million this quarter higher than in recent quarters. As usual increased TIGRIS sales to Novartis are a good thing for downstream revenues, but not such a good thing for the gross margin percentage in the current quarter, as these sales are made contractually at cost. Q3 blood screening sales also benefited from uptick in Novartis ordering patterns. We’ve talked about this phenomenon in recent quarters, and you might recall that in our last call, we anticipated that Novartis would order less product in Q3. As it turns our, Novartis bought more product than usual, primarily of our West Nile virus test. We believe this may have been due at least in part to a desire to replenish inventory levels that were depleted based on increased, individual donor testing during the summer mosquito season. We estimate that the magnitude of this benefit was a little more than $2 million, in the quarter, at least compared to recent historical averages. Furthermore, we believe that Novartis essentially pulled forward one of their orders that was originally planned for Q4. This means that Q4 shipments, and therefore blood screening revenue, will likely be reduced by a similar amount on a sequential basis. Although we gained about $2 million of additional shipment revenue in Q3, we gave back about $1 million of the benefit by agreeing to reimburse Novartis for certain warranty costs associated with the blood screening business. Based on how the accounting rules work, we were obligated to record our increased payment obligation as an offset to product sales, rather than as in increase to cost to goods sold. So this trend our blood screening revenues, as well as our gross margin dollars, by about $1 million in the quarter. Before I leave blood screening, let me mention that we believe we have found our first case of hepatitis B yield in the post-marketing study for the PROCLEIX ULTRIO assay. Recall that yield is defined as an HBV-infected blood donation that is intercepted by ULTRIO, but that was initially negative based on serology testing. In other words, yield is a case of HBV infection in the window period when protein-based tests are ineffective. Blood bank customers in the ULTRIO post-marketing studies have screened about 260,000 donations so far, so we believe finding one yield at this stage is completely consistent with the statistical averages predicted by numerous analytical studies and our customer experiences outside the U.S., where the test has been commercially available since 2004. As we said in our press release, this first yield must be confirmed by the FDA, through their eventual review of our supplemental biologics license application, or BLA. As a reminder, we intend to submit this BLA once we have found two yields, the threshold the FDA has asked us to meet. As you can imagine, the timing of the second yield, like the first, is inherently uncertain. What I can tell you is that the agency typically takes four to six months to review a supplemental BLA. After that, we hopefully would be granted a hepatitis B screening claim, which Novartis could use to negotiate commercial pricing, a process that usually takes a month or two. That increased pricing for early adopting customers would begin the flow into our income statement, after the typical two-month revenue recognition lag. As we mentioned in our last call, we also look forward to the American Red Cross, our largest blood bank customer, conducting their own yield study. Protocol is drafted, but because the ARC needs some additional time to implement administrative and logistical procedures on their end, we understand that they are now planning to start this study early in 2008, rather than in Q4 of this year. So to summarize the blood screening discussion, we had a very solid performance in Q3, and we are right where we expect to be with our yield study for the ULTRIO assay, which we hope will be a major growth driver for the company over the next couple of years. Now let me turn to one of our most important pipeline projects, our HPV program for cervical cancer. I’d like to make three points regarding HPV. First, we are very pleased with the analytical and clinical performance of the assay to date. Some of you may have seen the 220 patient study we conducted with a French opinion leader that was presented earlier this month at the annual meeting of EUROGIN, which if you’re interested, stands for the European Research Organization on Genital Infection and Neoplasia. In this study, our APTIMA HPV assay showed good analytical agreement of about 86% with the one competitive test that is approved in the U.S. Of the 16 samples that were positive by our APTIMA test, but negative based on our competitor’s assay, 12 resolved in our favor when tested with an independent molecular genotyping assay. And of the 15 samples that were negative according to our assay, but positive by our competitor’s test, 12 resolved in our favor when genotyped. In terms of clinical performance, the sensitivity and specificity of the two assays were statistically comparable in this relatively small patient population. Similar results have been seen in other studies, one of which will be presented next week at an HPV meeting in China. All in all, we believe these data, if confirmed in additional studies, will be very compelling to customers, especially since our HPV test employs familiar APTIMA chemistry on our fully automated TIGRIS system. Second point regarding HPV is that we have received productive guidance from the FDA on the design of our pivotal clinical trial, and that we believe this guidance is consistent with what our potential competitors have been told. For example, I know that some of you have been concerned that we would be required to follow patients for three years in order to gain approval. After discussing with the FDA, we do not believe that three-year follow up data will be necessary to gain additional approval. Each patient will be tracked for three years, but as we have said before, we believe this can be done after approval, as a post-marketing study. Obviously final approval will be contingent on successfully completing this post-marketing study and on the long-term data confirming the initial results. In order to gain approval before the three year follow up period, we and our potential competitors have been asked to collect HPV sequencing data on all subject in the study. This new requirement will add expense to our study, but will also contribute to a slight delay in the start of the trial, as we amend the protocol and validate new testing procedures. As such, we now expect the U.S. pivotal study to begin on the first quarter of 2008, rather than the end of this year. Let me emphasize, however, that from this point forward, the rate limiting step in our HPV program is how quickly we are able to enroll the required patients, and what the disease prevalence is in our patient population, especially in the [ASCS] arm of the trial. The third and final point I want to make about HPV is that we remain on track to launch a CE mark product in Europe in the second half of next year. European performance evaluation studies are underway now, and early reports are positive. As Herm will explain, these studies will contribute to an increase in sales and marketing expense in Q4. We believe the European HPV market is poised for growth, and as I alluded to before, we will be putting additional people on the ground in Europe to attempt to capitalize on this opportunity and develop it further through scientific marketing. So all in all, we’re pleased with the progress of our HPV program, which we think will be an important value driver for us in the medium- to long-term. Now before I turn the call over to Herm, let me just mention two final points related to other R&D projects. First, we have yet to make a final decision regarding the timing of the U.S. clinical trial for PCA3, and we continue to evaluate the incremental costs and revenues associated with a stand-alone assay. As you might imagine, we’re working through our 2008 budget process now, and we’re very cognizant of adding R&D costs to 2008, especially since we expect to run a very expensive HPV clinical trial throughout the year, a trial that just became even more expensive due to the FDA’s requirement for sequencing data. In addition, we expect the ARC study for the PROCLEIX ULTRIO assay to consume significant financial and human resources, especially in our clinical organization. Having said that, we continue to be enthusiastic about the near-term commercial potential of PCA3. Sales are small, but ramping up nicely both in the U.S. and overseas. As I mentioned before, we believe we have enough experience under our belts to begin adding additional sales and marketing resources in Europe, to help accelerate adoption there. In addition, we remain very optimistic about the potential of TMPRSS2, the prostate cancer gene fusion we licensed from the University of Michigan. A rapidly growing body of scientific evidence suggests that certain gene fusions are closely correlated with prostate cancer aggressiveness. For example a study of 455 prostate cancer patients published recently in the journal Oncogene by researchers from the Royal Morrison Hospital in the UK and Memorial Sloan Kettering identifies specific gene fusion that is strongly associated as statistically significant levels with lethal prostate cancer. Researchers concluded that a P value of .003 that this particular fusion provided prognostic value over and above that offered by Gleason scores and that offered by PSA levels. Shifting to our industrial partnerships we continue to anticipate launching our first product through our collaboration with Millipore by the end of this year. As we have said before we do not expect the first individual bacterial assay to generate near term revenues but we do believe it will be an important proof of concept for biopharmaceutical manufacturers demonstrating that molecular technology can be used to provide faster more accurate detection of contaminated production processes. We expect to launch a series of products with Millipore over the coming year so stay tuned for more developments. Now I’ll turn the call over to Herm to review our third quarter results in more detail as well as our increase guidance.
Thank you Hank and good afternoon everyone. Since Hank already discussed product sales I’ll start with collaborative research revenues which were $3.1 million for the third quarter of 2007, more than double the 1.5 million we recorded a year ago. This increase resulted primarily form higher funding by Novartis, with reimbursement from 3M, Millipore, and the US Department of Defense contributing as well. Looking ahead to the forth quarter we expect collaborative research to increase on a sequential basis based primarily on milestone payments we expect to receive from our partners. Royalty and license revenues were 1.2 million in the third quarter a big decrease compared to the $7.3 million in the prior year period. Royalty and license revenues were high in the third quarter of 2006 based on an aggregate $6 million of revenue we recognized from Bayer and from Tosoh. Without these payments, royalty and license revenues were essentially flat year over year and we expect this line to remain sequentially flat at around a million dollars in the fourth quarter of 2007 as well. Now let me turn to gross margin on product sales which was 67.3% in the third quarter, down considerably from 70.9% in the prior year period, which was a recent high. This decline in the gross margin percentage was primarily to the negative impact of instrument sales. As Hank said, we sold$ 3.2 million of TIGRIS instruments to Novartis in the quarter, compared to about 2 million of instruments and spare parts in the prior year period. In addition, compared to recent quarters, we sold roughly an incremental $3 million of instrumentation to currently new clinical diagnostic customers and these were sold at a very low margin. If you do the math, this incremental $4 million of instrument sales decreased our quarterly gross margin percentage in the neighborhood of 200 basis points. In addition, and this is a minor point by comparison, the gross margin percentage was higher than usual in the third quarter of last ear due to an increase in development lot production. As a reminder when we make development lots, fixed overhead costs are pulled out of cost to goods sold and into the R&D line, and in addition higher overall production volumes spread that overhead over a larger number of units improving the margin percentage further. In addition, a couple of other items that Hank discussed reduced our margin percentage this quarter. Namely, the million dollar charge we took on the Novartis warranty settlement and the additional shipment revenue on our West Nile virus assay. As a reminder blood screening shipment revenue is recorded at a lower margin transfer price until the tests are actually used to screen blood, at which time we receive higher margin true up revenue. Once you take all these factors into account, the underlying margin percentage on our assay sales was fairly consistent with where we expected to be when we had our last call. Realistically however it is very difficult to report gross margin percentages above 70% in quarters like this one when we had unusually high instrument sales. Research and development expenses for the third quarter of 2007 were $27.6 million, up 14% compared to last year and right in line with the guidance we gave in our last call. As discussed R&D expenses were high primarily based on the bulk purchase of HPV oligoneucleotides from Roche. These costs will not recur in the fourth quarter and as a result we expect rand d expenses to normalize back down to the $25 million range we saw in the second quarter. I should mention that R&D expenses in the third quarter of 2007 were approximately $400 thousand higher than expected because we agreed in response to a comment letter from the US Securities and Exchange Commission that is now resolved to begin amortizing of the $20 million manufacturing fee that was paid to Roche and capitalized 2005. You might recall that we received this call in December of 2006 and first noted it in our 2006 10K. We will continue to amortize this $400 thousand quarterly expense into R&D until the time of our European product launch at which it will switch into cost of goods sold. Marketing and sales expenses were $9.7 million in the third quarter of 2007, up just 2% compared to the prior year period. Starting in the fourth quarter, however, we expect these expenses to increase primarily to accelerate sales of our STD and PCA3 products in Europe and to conduct rather significant performance evaluation studies of our HPV assay in front of it’s launch next year. As such we anticipate that sales and marketing expenses will increase by about $1.5 million on a sequential basis in the fourth quarter. General and administrating expenses were $11.4 million in the third quarter of 2007, down 10% from the prior year period, when we paid our outside litigation counsel $2 million for their roll in our successful Bayer patent litigation. Income tax expense in the third quarter of 2007 benefited from a $900 thousand credit associated with the completion of our 2006 federal tax return. This credit resulted from our typical practice of accruing tax expenses based on a preliminary estimate, then truing up this estimate when the return is finalized. All this nets out to a third quarter earnings per share of $.31, 11% higher than last year in line with to take revenue growth of 10% and ahead of expectations. In summary, a very good quarter for the company Based on our third quarter results we are once again increasing our fill year 2007 guidance, we now expect total revenues in 2007 of $400 to $402 million, the midpoint of which is 5 million dollars higher than our previous guidance of $392 to $400 million. I’ve already given you specific guidance on non product revenue and if you back out those figures you’ll see that we’re anticipating product ales to decline by at least a few million dollars on a sequential basis compared to the third quarter, but still increase slightly compared to the prior year period. We anticipate that this sequential decline will result form two factors Hank discussed, a significant reduction in clinical diagnostic instrument sales and the absence of the West Nile virus that was essentially pulled forward into the third quarter. Now let’s turn to guidance for the expense lines. In terms of gross margin on product sales, we expect to see the percentage improve in the fourth quarter, based primarily on lower instrument sales, none the less, given where we are nine months into the year we are lowering our 2007 guidance by 100 basis points, 67 to 68% of product sales. As I said before, we expect R&D expenses in the fourth quarter to return to roughly the 25 million dollar level and we are therefore maintaining our full year guidance that R & D expenses will range between 24 an 25% or total revenues. This percentage will be slightly higher than 2006 levels on a gross basis but lower if you net out the collaborative research funding we have received this year. We continue to anticipate 2007 marketing and sales expenses equal to between 9 and 20 percent of total revenues. Given the fourth quarter increase that I mentioned earlier which is tied to European market development costs, this line will likely finish close to the high end of this range for the year. We continue to expect GNA expenses for the full year between 11 and 12% of total revenues. In terms of the tax rate we believe that the fourth quarter rate will be similar to the third quarter level based on the expected completion of a California audit of our 2003 and 2004 state income tax returns. When all is said and done, the carious tax credits and adjustments we expect to receive this year will likely drive our reported rate down to approximately 24.5%. I would caution everyone however that we expect this to normalize back to an underlying rate of between 35 and 36% going forward into 2008. All this leads us to our new 207 earnings per share guidance of between $1.50 and $1.52 on a fully diluted basis, which raises our previous guidance by $.03 at the midpoint of the ranges. Our earnings per share guidance is based on a weighted average share count of between 54 and 55 million shares for the year, slightly higher than our previous guidance based on employee option exercises during the third quarter. So in summary, we are pleased with our overall financial performance in the third quarter. Both clinical diagnostic and blood screening sales set new quarterly records driving total revenues to an all time high. Earnings per share exceeded expectations as well despite a heavy planned investment in R&D for our HPV program. And we are increasing our full year guidance for both total revenues and earnings per share. This concludes the financial section of our conference all which I will now turn back over to Mike.
Thanks Herm, we’re happy to take your questions now. For Q & A we’re joined by Carl Hull, executive VP and COO, Bill Bowen, senior VP and general counsel, Steve Kondor, senior VP of sales and marketing, Lynda Merrill, VP of industrial relationships, Harry Rittenhouse, director of cancer research and Kevin Heardy, senior director of finance. 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. Operator we’re ready to take the first question
(Operator instructions). And your first question comes from David Lewis of Morgan Stanley David Lewis - Morgan Stanley: Good afternoon. Hank, I wanted to start off with equipment sales. They were a little heavier than obviously you or we were anticipating. I was wondering if this was an anomaly or it’s a trend, so is there any sort of additional feedback you could provide in terms of the magnitude of theses sales, whether the relative rate hat was in blood screenings, what was in clinical diagnostics. You also mentioned some of these were new and some were re-up users. I wonder if any of these users that bought a second system were diagnostic customers, so any detail you can give us on equipment would be very helpful.
I’ll take the first of those fourteen questions. I think it really is an aberration, and I think the instruments on comparative basis compared to an average month we sold more on the diagnostic side than we did on the blood screening side. I wouldn’t expect that to continue. David Lewis - Morgan Stanley: Okay and then international has gotten more attention here in the last coming quarters. I guess you’re talking about an increase in sales in marketing. Can you give us a more specific idea of what you’re envisioning for international as we head into 2008 and 2009, and what kind of steps is the company willing to take to accelerate their business international perhaps coming off of the HP launch in the back half of the year?
We probably have about 15 people in international right now, most overseas; we have a staff here of course. And next year, and I’ll defer to Steve on this, but I think we’re planning on adding about five or so in Europe primarily. Steve?
That’s correct Hank. David we are planning to add about five or so in Europe obviously to support the eminent launch of HPD, we have people today in the Germanic speaking countries, we’ll be adding folks in Italy and Spain and France and other countries in Europe as well. We have a presence in the UK and we’re supplementing that, our business continues to grow there on the STD side as well. So what we want to do is make sure we’re well positioned in the countries to support not only our new products such as HPV PCA3, but the emerging and growing STD business in Europe as well. David Lewis - Morgan Stanley: Steven, just following up to that, you have sort of a dominant US GC position. Overseas is certainly not dominant and one of your competitors has placed a dramatic number of boxes or midrange systems overseas. What are your expectations for the go to the take market shares overseas, specifically in DC?
Well we have done that this year pretty well and that’s what’s buried in the numbers here in terms of the STD growth. We’ve placed seven TIGRIS’ in Europe alone this year and so on the high volume lab sector we’re targeting those with obviously a differentiated platform, the TIGRIS. In the mid volume range and the lower volume range, that’s where we anticipate that Panther will be able to come in and garner more (inaudible) David Lewis - Morgan Stanley: Okay and then maybe one last question for Carl or for Hank. You’ve talked about research and development leverage, or we have talked about research and development leverage throughout this year, could you give us an update on you’re likelihood or willingness to grow your research and development pipeline through acquisition versus the PNL and any sort of increase in activity on the business development front you’ve had in the last six months.
Let me start off, and then I’ll give it to Carl, so you get familiar with Carl’s voice. We don’t anticipate a big hike next year. We’re always looking for acquisitions, I think we discussed in this phone call just haven’t seen anything yet, can’t really see making an acquisition that will increase R & D expenses. We would like to do something to expand our footprint geographically, specifically in Europe to get us a little more infrastructure over there.
David, it’s Carl. I think that we feel comfortable with our level of R & D spend as it has been in the past couple of quarters, nothing the exceptions that Herm mentioned this quarter for the one time, HPV expenses. I think that we’re doing our best to focus those dollars on the key programs to accelerate those programs individually and as a group and I feel that there’s not a need for an internal or organic expansion of that spin level right now. David Lewis - Morgan Stanley: Great. Well Carl I think your voice is going to give Hank a run for his money. Alright thank you.
Thank you your next question comes from Quintin Lai of Robert W. Baird Matthew Notarianni - Robert W. Baird: Good afternoon guys. This is actually Matt for Quintin. Congratulations on the quarter
Thank You. Matthew Notarianni - Robert W. Baird: Just a couple of quick questions. As the cash balance continues to rise you kind of spoke about not seeing anything interesting in the way of acquisitions, but could you provide a little color on what your plans might be to put that cash to work?
We are looking assiduously at candidates to acquire to broaden our businesses space both geographically and in a product sense. We’re not anticipating paying a dividend and we are not anticipating buying back our stock. But we do continue to generate an awful lot of cash and we expect to find a useful use for that. Matthew Notarianni - Robert W. Baird: Would it be fair to say that it might be in the form of just taking on other projects or investing more in these shots on goal as you guys sometimes say?
I think we’re reluctant to increase our R&D spending as percentage of revenues so I think it’s going to be more external than internal. Matthew Notarianni - Robert W. Baird: Great. Thank you for that. And just in recent weeks we’ve gotten a lot of press on health care acquired infections, particularly MRSA. Just wondering of you guys could provide some more color on where that stands right now with 3M and how that’s developing for you guys.
We’re moving along beautifully, right on schedule. We remain very enthusiastic about it, I just heard it on the news, I think it was Illinois; they’re going to start testing patients upon admission to hospitals as way to control and combat MRSA infections.
Yeah just to add to that Hank, we also have on target with regard to our feasibility milestone, we have a milestone to reach feasibility for MRSA and we’re on track with that so everything is good news there. Matthew Notarianni - Robert W. Baird: Thank you very much. Congratulations again.
Thank you your next question comes from Bill Quirk of Piper Jaffray. Bill Quirk - Piper Jaffray: Thanks good afternoon.
Unidentified Company Representative
(In unison) Good afternoon, congratulations. Congratulations on your new son. Bill Quirk - Piper Jaffray: Oh thank you. Thank you very much. Bill Quirk - Piper Jaffray: Thank you. Couple of quick questions Hank: So thanks very much for, first of all, addressing HPV and the timelines and you are right so, do we, can we say at this point that we can pretty much put this three year prior to filing issue to bed? So to speak.
Sorry I don’t understand. Bill Quirk - Piper Jaffray: So the question is, Hank you mentioned that we have had some very constructive conversations with FDA, over the what data will be required to file for HPV? And so what I’m trying to get to here is a level of confidence that we are not going to say, go the di-gene pathway. Or we are going to have the three year follow-up data prior to submission
I think we have been probably overly conservative in the past, particularly compared to one of our potential competitors. And I think we are getting more comfortable and I think you can expect a more reasonable estimate of the amount of time it is going to take to get to the market. Bill Quirk - Piper Jaffray: OK, fair point. You may have mentioned this, I am sorry, I may have missed it earlier but did you talk about the number of donations we have screened thus far vis-à-vis the first yield case.
Yeah I think we did it is about 200 and...
Unidentified Company Representative
About 260 Bill. Bill Quirk - Piper Jaffray: 260 Okay, great.
Pretty much on schedule. So I’ll go on a limb and say that, I would expect that we’d get the second one certainly by the end of the year. Bill Quirk - Piper Jaffray: Sounds good that certainly would be
That is a limb that Hank, that he has just perched himself on Bill Quirk - Piper Jaffray: I’ll make sure I will refer to the disclosure statement Mike, thank you guys.
Thank you, next question comes from Peter Lawson, of Thomas Weisel. Peter Lawson - Thomas Weisel: I wonder it you could give us an update on the prostate cancer initiative; where it stands with the FDA? If it is still going to be urine based?
Harry can I turn that over to you?
Yes, the strategy remains the same regarding PCA-3, it will be urine based. We are developing a more automated technology form for the assay, which is going to improve the analytical performance. The clinical research studies are being expanded and continuing so we are getting better definition for what the clinical trial design is going to look like. Peter Lawson - Thomas Weisel: When is this, a filing, expected with the FDA?
We still have not definitively decided on that peter we’re still going through the analysis. I think as I read earlier in my prepared comments, it is a terrific product it has generated a huge amount of enthusiasm in Europe as well as in the US and I think the tandem of PCA-3 and TMPRSS will be very, very, compelling for the urologist.
I should add that our strategy is a portfolio of prostate cancer tests that will include tests for treatment selection and prognosis. The studies with TMPRSS are going quite well and independent studies are showing positive results which make us more confident that TMPRSS with a fish test or a urine test, probably both, are going to be very useful for treatment selection and prognosis Peter Lawson - Thomas Weisel: I wonder if you could talk to HPV tests; how you are going to set yourself against the competition? What’s the competitive advantage for your sales force?
Hi Peter, I think the major advantages you will see for our HPV assay will be predicated on our ability to automate the assay in high volume, and do so with a standard and familiar Aptima assay format. This will really distinguish us from everybody that is out there today. Of course, underlying that, will be analytical performance that is at least as good as what is out there on the marketplace today. And we frankly feel, as you see the data unfolding over the course of the next couple scientific meetings, some significant improvements are possible using our design of the assay. And I think, at the end of the day those two things will be more that sufficient to hang our hat on in this marketplace. Peter Lawson - Thomas Weisel: Okay. And just finally I wonder if you could just break out the revenue by geography and if there was any FX benefit this quarter?
It is… Outside the US continues to approximate 15% Peter, as it has pretty much every quarter and certainly every year over the last several years. The FX effect on the quarter was insignificant. Peter Lawson - Thomas Weisel: Okay, thank you so much.
Thank you, next question comes from Zarak Khurshid of Caris and Company Zarak Khurshid - Caris: Hi guys, thanks for taking my question. You may have already covered this, I apologize, the level of interest income, is that sustainable for the foreseeable future?
Unidentified Company Representative
Well that’s going to depend on the rates which we’d all like to see come down potentially another quarter of a point pretty soon, they talk about. So the rates may come down a bit, but the cash is building nicely so I think it is sustainable; unless as Hank and Carl have mentioned, we do find an acquisition that makes sense for Gen-Probe. We have not yet but it may come along at some point. Zarak Khurshid - Caris: Right, great. And then, sorry to harp on the PCA-3 business but last quarter it sounded like you were getting close to making a decision on the marker strategy. I guess my question is what exactly has changed since then on that front?
I don’t want to sound flippant. But we are getting even closer and really nothing has changed we are looking at the cost, at the advantages of doing this, of doing it simultaneously with the introduction on TMPRSS and our analysis is not yet finished. Zarak Khurshid - Caris: Perfect, thanks. And then you mentioned significant unit volume remaining with… within pace. How much unit volume was in PACE at the start of the year, and would you expect similar rate of cannibalization going forward in the STD business?
We anticipate that we will be at 80% revenues being APTIMA, 20% being PACE. And in terms of the units we still have about 40% of the units, the testing volume, at the end of this year being PACE. Zarak Khurshid - Caris: Okay, great. And I just wanted to say best wishes to the Gen-Probe family in light of the fire.
Thank you, your next question comes from Dan Leonard of First Analysis Corp. Dan Leonard - First Analysis: Good afternoon, a couple of things. One, for your fourth quarter revenue outlook; you mentioned that you pulled some business forward from Novartis into the third quarter. How much was that? The West-Nile Virus business that you pulled forward.
Well we didn’t pull it forward; they brought it forward. And I think that was about $2 million of product revenue. Dan Leonard - First Analysis: Okay, so that piece, plus the instrument aberration in the quarter is what would get you to the lower Q4 revenue number?
That’s basically it Dan Leonard - First Analysis: Okay, and then on the expenses for the fourth quarter, you mentioned a number of different expense items that would be higher that maybe we were originally looking for to bring your earnings lower than the street. Can you ordinally rank those for me?
I think I mentioned one, which was sales and marketing expense related to our European launch of HPV starting with Europe for that next year. That was the only one that I mentioned that would be higher. Dan Leonard - First Analysis: I thought you mentioned sequencing for HPV that might increase costs and other things as well. Is that not true?
Yeah, that will be next year as we go into the HPV clinical trial. Dan Leonard - First Analysis: Okay, thank you very much
Thank you, your next question comes from Bruce Cranna of Leerink Swann. Bruce Cranna - Leerink Swann: Good afternoon guys
Hey Bruce. Bruce Cranna - Leerink Swann: A lot of this stuff has been touched upon. So I guess I just want to go through some of the finer points. Hank, just again on --- I think this question was asked but I didn’t think I heard and answer on the TIGRIS sales, the instrument sales, on the clinical side in a quarter. I understand it was sort of an aberration, but the comment about a portion of that and maybe a good portion being to existing accounts. Those -- we are talking about parts or are these actual instruments and accounts running more than one instrument?
These are actual instruments. Bruce Cranna - Leerink Swann: So this is a situation where an account needs greater volume so they are starting another TIGRIS.
No it is some of the accounts had the TIGRIS instrument there and decided to buy it. And it is really a sense of a long-term commitment to the instrument and to Gen Probe as a supplier. Bruce Cranna - Leerink Swann: Okay, and a couple quarters ago I seem to recall you parted with a worldwide base number on TIGRIS. Do you happen to have that number again?
Installed base? Bruce? Bruce Cranna - Leerink Swann: Yes sir
Worldwide. Why not call diagnostics see if they have that information
Unidentified Company Representative
Just about half and half I would say. 100 to 110 or so.
Unidentified Company Representative
That’s ballpark Bruce.
Is that pretty close to the number we gave you the last time Bruce? Bruce Cranna - Leerink Swann: That’s not bad I think it was 160 on the first quarter so that sounds pretty good.
Bruce if you come to our analyst’s day we will give you a more precise update. Bruce Cranna - Leerink Swann: I’ll hold you to that Mike. Then again I… Just on PCA-3, I guess Hank, so it sounded to me like maybe you were taking your foot off the gas a little bit due to HPV spending. Is that not sort of… Did I not get the right read on that, on PCA-3?
I can’t argue with that, but I would say that we are probably putting the pedal to the metal in terms of the analysis and all the implications of going forward with the US IBD as PCA-3 is currently formulated. Bruce Cranna - Leerink Swann: As I recall you guys, at one point, were getting some funds from the DoD; is that still the case?
Yes Bruce Cranna - Leerink Swann: And will that move into ‘08 as well you think?
Those funds, probably not Bruce Cranna - Leerink Swann: Could that be re-upped I guess is what I’m saying?
It could be, but I think it is probably unlikely to occur next year. Bruce Cranna - Leerink Swann: Okay, and last sort of persnickity question from me. In general your sense on the HPV side is it too early to talk about your “all a go” cost ’08 versus ’07 or do you care to comment on that at all, on which way that might move?
It’s too early Bruce. Bruce Cranna - Leerink Swann: Okay, just thought I’d ask. Alright, thanks guys
Unidentified Company Representative
Thank you sir.
Thank you, your next question comes from Spencer Nam of Summer Street Research Partners Spencer Nam - Summer Street Research Partners: Hi, thanks for taking my questions, just a couple of quick questions. On the HPV screening side, hank you were kind enough to give us a little more color on the future. When do you recognize the $10 million from Novartis, is that when you find the second case? Or is that when you get the FDA go-ahead?
It is the FDA approval on the ULTRIO assay on TIGRIS. Spencer Nam - Summer Street Research Partners: Okay, I appreciate that. And then you also mentioned hank in your prepared comments that PCA-3 is ramping up nicely; can you give us a little more details on that maybe, if possible. What are we seeing, both here and the Europe, how are the physicians receiving the tests and what sort of test scale are we talking about?
Let me turn it over to Steve who can address all that
Spencer, we said in the last call we anticipated a couple million dollars in revenue for PCA-3 between the US ASR product and the Europe CE approved product so that’s staying about that, we have seen. And we have had recent activity in Europe with regard to our market development program creating awareness among urologists about the availability of the PCA-3 test and its clinical utility. I think we are starting to see some up tick on that, particularly in Europe, as well as, I think, through the halo effect here in the United States with our ASR labs. So unit volume at these labs is starting to increase and we expect that to continue throughout the year. Spencer Nam - Summer Street Research Partners: And in terms of the labs that they involved in using the PCA-3, we don’t expect such a growth in the number of labs in 2000... The rest of the year and going forward, is that fair?
That is correct Spencer. Spencer Nam - Summer Street Research Partners: Great, thank you.
Okay, your next question comes from Tycho Peterson of J.P. Morgan Tycho Peterson - J.P. Morgan: Hi, good afternoon.
Hi Tycho. Tycho Peterson - J.P. Morgan: You have talked in the past, you have at least given some limited color about potentially the distribution strategy for PCA-3. Can you give us a sense of, you know, what point you make the decision. Is it over the next year when you decide you will partner with a Labcorp or Quest in terms of pushing the tests onto the market?
Yeah it will be once we make our decision regarding PCA-3 how we are going to go forward. It will be within a year of making that decision to allow ample time before launch. Tycho Peterson - J.P. Morgan: Okay, you talked about some of the TIGRIS placements on the diagnostic side in Europe, you know. Can you give us a sense of whether these are competitive wins and the underlying question there is: Is there still some lingering talk about some of the Chlamydia strains and potentially the N2000’s inability to pick them up. And I’m just wondering: A, how often are you having bake-offs and B, whether there are competitive wins happening?
Yeah Tycho, of the seven new TIGRIS placements we have in Europe this year, five of those are competitive takeaways actually. And two are just STD programs that have increased their volumes and have ordered additional TIGRIS’. So that’s the market that we are targeting over there in Europe. Tycho Peterson - J.P. Morgan: Okay, great. And just sell me on the Novartis warranty issues, does that work through this quarter? I’m not sure if you commented on how quickly that will carry through.
I think about half of it goes through this quarter. Tycho Peterson - J.P. Morgan: Okay, great. Thank you very much
Thank you, next question comes from [Doug Shankle - Cohen] Doug Shankle - Cohen: Hi, good afternoon.
Hi Doug. Doug Shankle - Cohen: On follow-up on much of your R&D commentary. I believe you previously talked about commencing a U.S. pivotal trial in HPV by year-end. I apologize if you talked about this already, but is this still the case?
We probably would have been able to do that Doug, were it not for the change in the genotyping requirement. We expect now the initiation to be in the first quarter of next year. Doug Shankle - Cohen: Okay. Thank you. I know there was some news on the Japan Green Cross bid. Is there any more detail you can provide on that bidding process and how that unfolded?
I don’t think there’s much that we can say on it. Doug Shankle - Cohen: Okay, and one last housekeeping question. Any chance you could provide us with the impact on an absolute dollar basis of the contribution of West Nile virus pricing compared to last year?
Unidentified Company Representative
I’m looking around the table and everybody is shaking their head. So I guess I’ll go with the consensus on that one Doug. Doug Shankle - Cohen: Alright, well maybe we can talk about it after the call. Thanks for taking my questions.
Thank you. Your next question comes from Michelle Ha of Ferris Baker. Michelle Ha - Ferris Baker: Hi good afternoon. Congratulations on the quarter. Your guidance assumes on the previous question that the $2 million in product revenue from Novartis as well as equipment sales will not recur in Q4. What is, I hadn’t modeled this much equipment sales, what sort of drives that, or what can we do to anticipate that better going forward?
I would not anticipate additional instrument sales at that level.
Unidentified Company Representative
Yeah Michelle, they were truly one time, as Hank indicated in the prepared remarks. Michelle Ha - Ferris Baker: Okay, and going to clinical diagnostics and blood screen revenue, can you give us a number there of what your market share is now compared to what it was a year ago in your STD franchise and also comment more about the international revenues from ULTRIO?
Michelle, this is Steve, I’ll take it, your question regarding clinical diagnostics and market share. We believe right now our market share worldwide to be about 50%, that’s both in terms of revenues as well as in terms of tests. In terms of dollars, I mean, excuse me, in terms of U.S. market, we are at about 60% of the market, again in terms of revenues as well as in terms of tests. And we are, according to the figures that we have seen, our market is growing, we’re growing at a little over twice the rate of the market. Michelle Ha - Ferris Baker: Great, thanks a lot.
Operator, I think we may have time for one or possibly two more questions.
Okay. Your next question comes from Jon Wood of Banc of America. Jon Wood - Banc of America: Hey, thanks a lot. If you were to get an opportunity to do a deal in Europe, to boos the infrastructure there, how sensitive is management to near-term PNL dilution?
I think with the right opportunity Jon, we would be able to withstand some near-term dilution, with the offset of high potential of accretion. Jon Wood - Banc of America: Okay. And then, given it doesn’t seem like you’re too excited about any other diagnostic technology out there, is a deal likely to target a distribution-type asset, or could you comment on, what kind of asset you would be interested in?
Well, we think that the technologies we have are pre-eminent in the field, but there are certain technologies that we don’t have, that would be interesting. As an example, in relation to HPV genotyping, sequencing. Some of that would be nice to have. So I couldn’t see us going after a distributor, we’d want to get more than just that. Jon Wood - Banc of America: Okay. One quick one. The American Red Cross ULTRIO post-marketing study, is it safe to say that organization wouldn’t adopt ULTRIO until that’s complete?
You know, probably, I hate to duck this one, but the best people to talk to would be those at (inaudible). Jon Wood - Banc of America: Okay. And then when do you, how long do you think an American Red Cross specific study would progress?
Unidentified Company Representative
Well, one is just to get them familiar with the assay and secondarily is to pick up yield, in addition to the yield we’re already getting from our own independent study. So that’s a tough call. I would say, yeah, less than a year, six months. Jon Wood - Banc of America: Okay, thanks a lot.
Unidentified Company Representative
You’re welcome.
Thank you, your last question comes from Zarak Khurshid of Caris & Co. Zarak Khurshid - Caris: Hi guys, thanks for taking the follow up question. With respect to the HPV trial, do you have a ballpark estimate for the cost there, and then maybe if you could quantify the incremental uptick for sequencing.
It’s Carl. We don’t really comment on the detailed cost at an individual program level. Suffice it to say that our budget and our plans for this program are for one of the largest clinical trials in Gen-Probe’s history. As you look at other data that have been disclosed about the investments that other competitors have made here, we would consider our spending to be consistent with that. I can’t really comment on the uptick related to sequencing requirements because there’s some puts and takes related to that, and we’re still finalizing our approach there. Zarak Khurshid - Caris: Great, thank you.
Operator, we do have some brief closing remarks.
Well, I’d like to thank you all for your questions, and to wrap up, Gen-Probe had a strong third quarter, with solid underlying growth from both clinical diagnostics and blood screening and earnings per share ahead of expectation. In addition, we made important progress on expected value drivers, including our yield study for the PROCLEIX ULTRIO assay, and our HPV development program. Before we sign off, Mike has asked me to remind you that our annual Analyst’s Day is planned for the afternoon of Thursday, November 29, at the Loews Regency in New York. Please watch your email for more information, and we look forward to seeing many of you there. Thank you for your time and attention today and please contact us if you have any follow up questions.