GoPro, Inc. (GPRO) Q3 2011 Earnings Call Transcript
Published at 2011-11-03 17:00:00
Welcome and thank you for standing by. At this time, all participants are in a listen-only mode. After today’s presentation, we will conduct a question-and-answer session. (Operator Instructions) Today’s conference is being recorded, if you have any objections, please disconnect at this time. I would now like to turn the call over to Mr. Mike Watts, Vice President of Investor Relations. Sir, you may begin.
Thank you, Crista, and good afternoon, everyone. I am pleased to welcome everyone to this conference call to discuss our third quarter 2011-business results. A press release announcing our results was issued today just after 4 p.m. Eastern Time and is posted on our website at www.gen-probe.com. In today's call, Carl will first review our third quarter product sales and our pipeline progress. Herm will then discuss expenses and our updated 2011 financial guidance. We'll take your questions for the balance of an hour, then will post our prepared remarks on our website for your convenience and reference. Before we begin, let me first review our Safe Harbor policy. Forward-looking guidance, financial or otherwise, is only provided on conference calls or in our press releases. Any statements about our expectations, beliefs, plans, objectives, assumptions or future events or performance are forward-looking statements. For example, statements concerning updated 2011 financial guidance, financial condition, regulatory approvals and timelines, the development and commercialization of new products, future results of operations, growth opportunities, plans and objectives of management, market trends and future economic conditions are all forward-looking statements. These statements are not guarantees of performance. They involve known as well as unknown risks and uncertainties that may cause actual results to differ materially from those expressed or implied. Factors that might cause such differences include but are not limited to, those discussed in our SEC filings, including our most recent 10-K and all subsequent periodic reports. Copies of these reports are available on our website at www.sec.gov and upon request. Gen-Probe assumes no obligation and expressly disclaims any duty to update any forward-looking statements to reflect events or circumstances occurring after this call or to reflect the occurrence of unanticipated events. In addition, our presentation today includes information presented on a non-GAAP basis. We believe these non-GAAP financial measures provide meaningful supplemental information regarding the company's performance by excluding certain expenses and other items that may not be indicative of core business results. We refer you to the press release we issued this afternoon, which is available on our website, for a reconciliation of the differences between the non-GAAP presentations and the most directly comparable GAAP measures. Now I'll turn the call over to Carl Hull, Gen-Probe's CEO. Carl W. Hull: Thank you, Mike, and good afternoon, everyone. Gen-Probe's non-GAAP financial results in the third quarter of 2011 were in line with our expectations. We again generated very solid growth from our clinical diagnostic products led by the APTIMA women's health franchise. In the blood screening sales grew on a sequential basis as we began to recover in a predictable fashion from some of the supply chain issues that dampened our result last quarter. Overall, our core businesses remained resilient and we’re encouraged by that. At the same time, what really excites us is the steady emergence of our new product pipeline. Both the PANTHER launch in Europe and our Trichomonas launch in the United States are going well. And on Monday, we announced FDA approval for perhaps the most important incremental driver in our pipeline, our APTIMA HPV assay. We have a lot to cover today, so let’s get right into our third quarter results. Product sales were $136.4 million in the quarter, up 6% compared to the prior year period. Total revenues were $139.1 million in the quarter, versus the forecast of around $140 million that we provided in our last call. Most of this small delta came from a short fall and sales of research products and services. We were once again pleased with our profitability in the third quarter as non-GAAP product gross margin percentage was 70.3%. Gross margin benefited from favorable product sales mix namely, healthy sales of our APTIMA COMBO 2 Assay for Chlamydia and gonorrhea detection and by the weaker dollar compared to the prior year period. These factors combined with lower than expected R&D expenses at an improved tax rate led to non-GAAP EPS of $0.57 ahead of the guidance we gave last quarter, which was $0.53 to $0.55 a share. On a GAAP basis, we posted a significant loss of $0.33 per share due to a $39.5 million non-cash write-down in the value of our equity investment in Pacific Biosciences. The accounts called us and other-than-temporary impairment. Even though we have both the ability and the intent to hold this investment for the long-term, we wrote it down because the trading price of Pacific Biosciences ' stock may remain below our cost basis for an extended period of time. Set against the topic, current market valuations for public sequencing companies, this accounting decision reflects our historically conservative approach to managing the balance sheet. I’d like to clearly differentiate between our equity investment and our collaboration with Pacific Biosciences. Well, I am very disappointed by this right now; we remain pleased with how our early stage research work with Pac Bio is progressing. We continue to believe the sequencing will play an important long-term role in diagnostics. Based on the assumption the key issues such as robust sample prep, integrated workflow and bioinformatics interpretation can be solved together, we and Pacific Biosciences have unique capabilities that we are already applying to these challenges and we are comfortable with the progress we have made thus far. Now, let me turn to the components of product sales in the third quarter. Sales of our clinical diagnostics products were $86.6 million up a strong 16% compared to the prior year period or 15% on a constant currency basis. Growth was again led by our APTIMA Combo 2 Assay for detecting Chlamydia and gonorrhea. Combining our highly sensitive and Pacific APTIMA assay with the automation of TIGRIS and now PANTHER, continues to provide differentiated valued to laboratory customers, despite a mixed utilization and funding environment. In addition, the last couple of quarters have validated the investments we are making in our European commercial infrastructure which are leading to an increasingly global product sales base. While APTIMA sales were exceptionally strong domestically in the second quarter, this quarter they grew most rapidly outside the United States. Specifically, APTIMA sales outside North America grew in excess of 30% in the third quarter, a sharp contrast to the sluggishness reported by some of our competitors. Our new APTIMA product line for the parasitic STD, Trichomonas also performed well in the third quarter. Although it’s very early in the launch, and customer validations are still ongoing, Trichomonas did add nearly a percentage point of incremental growth to total product sales in the quarter. Interest in our test is high, and the sales funnel looks good. As we turn our attention to the HPV launch, it’s very encouraging that existing TIGRIS customers are eager to add complementary menu to their systems. With its unique automation capabilities, TIGRIS remains a powerful draw for customers who are eager to improve their own economics. For example, in a single eight-hour shift, hundreds of ThinPrep samples can be tested for Chlamydia, gonorrhea, Trichomonas and, now, HPV on the TIGRIS system, with less than an hour of hands-on time. And all this testing occurs from the same primary sample, boosting efficiency for the lab. To wrap up our discussion of clinical sales, the acquisition of GTI Diagnostics, which we completed in December of 2010, added a few hundred basis points to product sales growth in the third quarter, as expected. Finally, our LIFECODES transplant diagnostics products performed well in the quarter, growing more than 20% versus the prior year period. Now let’s turn to blood screening. Third-quarter sales were $47.4 million, in line with the forecast we communicated last quarter. Compared to the prior year period, this was down 6% as reported, or 9% on a constant currency basis. As anticipated, almost all of this decline was due to lower TIGRIS-related sales to Novartis, which were down about $2.4 million compared to the prior year period. It’s important to note that on a sequential basis, blood screening sales increased by about $4 million, as we began to work through some of the supply chain issues that affected us in the second quarter. This process will continue in the fourth quarter, when we expect to see further significant increases in shipments of assays and instruments to Novartis. Underneath the supply chain fluctuations, the fundamentals of our blood screening business remain solid. Global donations screened by PROCLEIX tests were up slightly in the third quarter, pricing remains stable, and margins were strong. Since the external blood screening environment hasn’t changed, let me highlight a few non-financial items that illustrate the depth of the relationships that we and Novartis enjoy in this market. First, earlier this month Novartis hosted at our headquarters a very successful meeting with about 70 global customers and prospects visiting San Diego for the annual AABB meeting. This was an excellent opportunity to show off the PANTHER instrument, which is on track to be introduced into international blood screening markets next year. Customer feedback on PANTHER was extremely positive, as it has been in clinical markets. Second, in connection with the AABB, the National Blood Foundation awarded one of our senior scientists, Jeff Linnen, the prestigious Dale A. Smith memorial award, which is given annually to an individual or institution who has employed technological innovation and creativity to improve the practice of transfusion medicine. Jeff was a key member of the team that developed our blood screening assays, and remains the leader of that assay development program today. As one example, Jeff and other Gen-Probe colleagues were co-authors on two recent scientific publications that demonstrated conclusively that the XMRV virus is not a threat to our blood supply. One paper was published in Science, and the other in Transfusion, by a distinguished group of authors including senior scientists from the NIH, CDC, FDA and the American Red Cross. When a pathogen emerges that potentially threatens the US blood supply, regulators and customers turn to Gen-Probe to help solve the problem. Although XMRV does not represent such a threat, there is a growing body of evidence suggesting that dengue virus, which is similar to West Nile and is spread by mosquitoes in tropical areas, may be a problem in Puerto Rico and some southern states. As a result, we and Novartis have begun a formal development program in this area, building off the prototype dengue assay that has already performed well in epidemiology studies around the world. We hope to begin regional testing on an investigational basis next year. This is one example of the important incremental investment opportunities that we are sometimes called on to pursue, above and beyond our already robust product development pipeline. Before I turn the call over to Herm, let me comment on the great news that I mentioned at the top of the call, the recent FDA approval of our APTIMA HPV assay. As I said in our press release, HPV was the largest, most complex, and most expensive assay R&D program we have ever completed, so regulatory approval is a major milestone for the Company. I’d like to commend our project team publicly for their innovative belief that we really could design and build a better HPV test, and their persistence in seeing that vision through to reality. As we launch our APTIMA HPV assay, we will be emphasizing two key messages, which will be familiar to any of you who have spoken with us over the last few years. These messages are not complex, but we believe they are powerful for the patients, physicians and labs who will benefit from our product. First, the APTIMA HPV assay has consistently shown better specificity than the older generation of tests in global studies involving about 45,000 women. In the screening arm of our US pivotal study, we demonstrated similar sensitivity to the market leader, but generated about 25% fewer false-positive results. In practical, real-world terms, this means fewer unnecessary colposcopies, less patient anxiety, lower overall healthcare costs, better patient care, and fewer physician complaints to our lab customers. Second, our APTIMA HPV assay leverages the well-established workflow and automation advantages of TIGRIS. The early success of our Trichomonas assay on TIGRIS confirms that automation matters. What’s more, HPV is a perfect fit for our installed base of more than 200 diagnostic TIGRIS units in the US, for a number of reasons. These include, the high volume of HPV testing, the highly concentrated laboratory customer base, the sexually transmitted nature of the disease, and the fact that the same specimen can also be tested with our assays for Chlamydia and gonorrhea, and Trichomonas. Importantly, workflow is a significant current limitation for competing HPV assays, as labs would tell you. So TIGRIS is uniquely positioned to reshape the competitive landscape over time. Recent market research confirms that these messages resonate with physicians and laboratory customers. In fact, the research said the poor specificity of current test is actually impeding greater penetration of co-testing, also known as adjunct testing or screening. Certainly the recent draft recommendations from the US Preventive Services Task Force – and the concerns they raised about unnecessary medical procedures have brought issues surrounding false positive test results front and center. This is an ideal time to be launching our APTIMA HPV assay. We believe our test, which was uniquely and deliberately designed for better specificity, will enable physicians to co-test with greater confidence, and therefore grow the overall market. There is no denying that we are very excited about our opportunity in HPV. At the same time, and we know this as well as anyone, market share does not necessarily shift overnight in the molecular diagnostics industry. Our commercial efforts will take time, money and careful strategic coordination. To catalyze these efforts, several months ago we formed a women’s health business unit, led by a former Roche executive, to oversee all the functional areas that contribute to our continued commercial success, from product design and development to marketing. I’m happy to announce that, based on their efforts, we already have product on the shelf and our world-class sales, service and support team has begun their launch, just a couple of days after approval. Before wrapping up, let me quickly say that we continue to have a good, productive dialog with the FDA on the two major products we still have under regulatory review. Over the last few quarters, we have achieved three significant milestones with the regulatory approvals of PANTHER in Europe, Trichomonas in the US, and now HPV. And, we continue to work hard on achieving clearance for PANTHER and PCA3 in the US. Given the complexity of the PANTHER submission, which was filed in May of this year, it doesn’t look like we will get clearance before the end of this year, which was our most optimistic guess. The discussions and analyses we are working through with the FDA are straightforward, but they take time. And we may have slowed ourselves down a bit as we focused most of our regulatory and clinical affairs resources on closing out our HPV PMA. So, while you can never accurately predict regulatory timelines, the most likely scenario for PANTHER clearance now looks like late in the first quarter of 2012 or into the second quarter. This would be toward the back of the potential window we have previously described, but still well within the bounds of what would be considered normal for a complex instrument 510(k). We continue to feel very good about our path forward with PANTHER, especially since automated STD testing sits at the very core of what has made Gen-Probe successful over the years. In addition, we are meeting our PANTHER placement goals for the year, and the system continues to perform well globally, so we have an excellent reference base of proven market experience under our belt. For example, PANTHER was approved by Health Canada in August, after less than two months of review time, and early customer interest has exceeded our expectations. We also believe we are nearing the end of what has been a necessarily long review process for our PROGENSA PCA3 assay for prostate cancer. As we have said many times before, oncology diagnostics is hard, and developing a cancer test always takes longer and costs more than you expect. As shown by the recent USPSTF recommendations on PSA testing, the deficiencies of current tools for prostate cancer diagnosis and management create opportunities for PCA3. But at the same time, they complicate the evaluation of new tests that must be compared against current standards of practice. With this backdrop, we have had very productive and collaborative discussions with the FDA in recent months. The FDA has not yet confirmed a new date for their immunology advisory panel to review PCA3, but we expect to have clarity on that issue soon. Extensive internal preparations are well underway, and in preparation for launch, we are making plans to strengthen our medical marketing capabilities in the urology field. This reflects our increased focus on the strategies, tactics and investments needed for effective commercialization. But at the same time, we are already looking ahead to the next wave of growth for Gen-Probe. Additional menu for the PANTHER system – especially viral load assays will be critical to ensuring that we introduce a steady stream of new products in the medium term. Toward this end, we recently manufactured the first development lot for our investigational HIV viral load assay on PANTHER, and are preparing for an RUO study in the developing world. Viral load assays will be an important part of our investments for Gen-Probe in 2012 and 2013, and we look forward to sharing more news as we work toward international product introductions in the 2014 timeframe. In summary, it’s really a very exciting time at Gen-Probe. Our core franchises remain resilient. APTIMA continues to grow, both in the US and internationally. Blood screening is a proven cash generator, with future incremental growth opportunities. The European launch of PANTHER and the US launch of our Trichomonas assay are proceeding well. We are launching our single most important new assay, HPV, with a differentiated message and an excellent domestic sales force. And we believe PCA3 and PANTHER are getting closer to the finish line in the US. Based on all these factors, we remain confident that we will generate low double-digit revenue growth in 2012, an acceleration compared to this year. Herm will now review non-product revenues, expenses and our updated 2011 guidance. Herm?
Thank you, Carl and good afternoon everyone. I’ll start by discussing collaborative research revenue, which was $1.1 million in the third quarter, down 68% from the prior year period. This decrease was due, as expected, to Novartis hitting their cap for reimbursement of PANTHER blood screening development costs earlier this year. Royalty and license revenue was $1.6 million in the third quarter, roughly doubling the prior year period due to increased royalties from Novartis related to the plasma testing market. As we’ve discussed in the past, plasma is an interesting market adjacency for us. Now let me turn to quarterly expenses, which I will discuss on a non-GAAP basis. Gross margin on product sales was strong in the third quarter at 70.4%, much better than the 67.2% margin we reported in the prior year period. Gross margin again benefited from a favorable product sales mix. This included higher sales of APTIMA assays, decreased sales of low-margin TIGRIS instruments to Novartis, and favorable currency fluctuations, at least compared to the prior year period. Research and development expenses for the third quarter were $27.8 million, up 2% compared to the prior year period due primarily to the addition of GTI’s R&D programs. R&D expenses were less than we forecast in our last call due to the timing of project expenses, mainly related to inventory usage. Marketing and sales expenses in the third quarter were $17.3 million, up 24% compared to the prior year period, due mainly to strategic investments in our European commercial infrastructure and the addition of GTI’s cost structure. As we’ve said before, we expect marketing and sales expense to continue rising more rapidly than revenue as we invest in European market and prepare to launch new products, including our HPV and PCA3 assays, in the United States. General and administrative expenses were $16.5 million in the third quarter on a non-GAAP basis, 53% higher than in the prior year period. Keep in mind that last year’s G&A number benefited from a $2.9 million credit related to Qiagen’s reimbursement of our legal fees related to our arbitration with them. If you were to exclude this credit, G&A expenses would have increased by about 20%, with the increase due mainly to the addition of GTI’s cost structure, outside legal costs associated with our patent infringement lawsuit against Becton Dickinson, and higher non-cash stock compensation expense. I should mention that all the operating expense lines in the third quarter were affected by an unusual increase in the cost of our employee medical benefits. This increased third-quarter expenses by nearly $800,000 compared to the forecast we used for our last guidance, and contribute to the change in our full-year guidance as well. Total other income in the third quarter was $1.8 million on a non-GAAP basis. This decrease of 38% resulted from a number of puts and takes. Cash balances were lower due to share repurchases, and a slight increase in realized gains from municipal bond sales did not fully offset foreign currency losses due to the strengthening dollar. Obviously these non-GAAP figures exclude the $39.5 million other-than-temporary impairment we recognized on our investment in Pacific Biosciences’ stock. Turning to taxes, our effective rate in the third quarter of 2011 was 29.6% on a non-GAAP basis, slightly better than we expected primarily due to reserves related to potential audits that were reversed due to expiring statutes of limitations. Our weighted average share count in the third quarter was 48 million, down slightly compared to the prior year period and the second quarter due to the benefit from our $150 million buyback, which we completed during the quarter. In addition, our board recently approved another $100 million repurchase plan, continuing our commitment to smart capital redeployment. So, on the bottom line, all this nets out to $0.57 of non-GAAP earnings per share in the third quarter, ahead of the guidance we gave in our last call, which was $0.53 to $0.55. We continue to do a good job of converting earnings into cash. We saw a strong operating cash flow of $42.3 million in the third quarter. Purchases of property, plant and equipment were $11.2 million in the quarter, mainly due to investments in our Manchester, UK, manufacturing facility, leading to free cash flow of $31.1 million. Moving on to the balance sheet, we closed the third quarter with $426.3 million in cash, cash equivalents and marketable securities. This is lower than the second quarter level primarily due to the completion of our $150 million stock repurchase program. Yet we still maintain a rock-solid balance sheet with nearly $4 of net cash and equivalents per share. This is net of $248 million of short-term debt, on which we pay interest at less than 1% pre-tax. This balance sheet provides us both strategic and financial flexibility, as demonstrated by our new buyback program. Now I’d like to turn to our updated 2011 financial guidance, which basically becomes fourth quarter guidance with nine months in the books. We continue to expect a very large fourth quarter on both the top and bottom lines, for the same reasons we discussed in July. However, given some of the puts and takes over the last three months, we are modifying our fourth quarter expectations slightly. As a reminder, our guidance is on a non-GAAP basis that excludes acquisition-related intangibles amortization, other transaction-related expenses, non-recurring legal fees, and restructuring charges. On the top line, we are tightening our revenue guidance range to between $575 million and $580 million of total revenues. This revenue guidance includes non-product revenue that will be similar in the fourth quarter to the third, totaling a little more than $13 million for the year. Backing out non-product revenue, the midpoint of our guidance assumes about 8% product sales growth in 2011. This is consistent with the expectation we laid out at the start of the year for high-single-digit growth. Underlying this will be solid growth from our women’s health, transplant and PRODESSE businesses, the addition of GTI, and a slight decline in blood screening sales. Given recent and pending new product approvals, we are confident that top-line growth will accelerate in 2012. As Carl said, we are well-positioned for a return to low double-digit growth in 2012, consistent with the goals we outlined a year ago. Our revised 2011 guidance still implies roughly a $20 million sequential increase in revenues in the fourth quarter. The vast majority of this increase relates to higher shipments of blood screening assays and TIGRIS instruments to Novartis, which will offset the inventory reductions that occurred earlier in the year. We have purchase orders for these shipments in hand, and have recently confirmed them with Novartis, so we feel good about this aspect of our forecast. As a reminder, however, we derive our reported blood screening number from both shipments to Novartis and end-customer demand. This customer demand, or true-up as we call it, can always fluctuate, especially as Novartis pushes into emerging markets. In addition to a significant increase in blood screening sales, we also expect sequential growth in the fourth quarter from both women’s health and PRODESSE products. We are, however, trimming our growth expectations slightly, mainly to account for the most recent foreign exchange fluctuations and a relatively slow start to the winter flu season. We are also reducing our forecast for the research products and services business, which has not performed up to our expectations. Turning to expenses, we maintain our product gross margin guidance of 69% to 70%. Although gross margin has been strong year-to-date, our guidance obviously implies a materially lower gross margin in the fourth quarter. This is due to the increased sales of low-margin TIGRIS instruments to Novartis that I just discussed. We expect research and development expenses to be around $30 million in the fourth quarter, reflecting increased spending on development lots and other project expenses, some of which we had expected to occur in the third quarter. We forecast that other operating expenses, on a combined basis, will be about the same in the fourth quarter as in the third. G&A is anticipated to be down sequentially due to lower legal expenses, while sales and marketing will increase in the fourth quarter due to expenses associated with the HPV launch. We anticipate that HPV and other new products will cause commercial expenses to grow faster than revenue in 2012 as well, as we’ve said in the past. Throughout the expense lines, we have baked in about $1.4 million in higher medical expenses for this year, which represents nearly $0.02 of earnings per share. To round out our 2011 guidance, we expect very little other income in the fourth quarter, resulting in around $6 million for the year. And as you model this line going forward, let me remind you that this year, other income benefited from nearly $5 million in realized gains on our municipal bond portfolio, which we do not expect to recur in 2012. Finally, we forecast that diluted shares will total about 48.5 million in 2011, mainly reflecting the completion of our $150 million buyback in the third quarter. On the bottom line, all this leads to our new non-GAAP earnings per share guidance of $2.28 to $2.32 on a fully diluted basis. We are trimming the top end of our EPS range mainly to reflect some conservatism on the various product sales items I discussed, and to incorporate the pacing of actual expenses in the third and fourth quarters. Nonetheless, we still expect a big increase in EPS in the fourth quarter, both on a sequential basis and compared to the prior year period. In closing, let me summarize the financial section of our conference call by saying that our third quarter results were in line with our expectations. We have adjusted our forecast for the fourth quarter slightly, but still expect significant growth that will lead to a successful full year, consistent with our original goals. In addition, the recent approval of our HPV assay and other pending regulatory approvals have us well-positioned for a return to low-double-digit revenue growth in 2012. Now, I’d like to turn the call back over to Mike.
Thanks very much Herm. I’d like to introduce the members of management who are joining us for Q&A today. We have Bill Bowen, Senior Vice President and General Counsel; Eric Tardif, senior vice president of marketing and corporate strategy; and Kevin Herde, Vice President and Corporate Controller. In order to ensure broad participation in today’s Q&A session, please be courteous and limit your questions to one plus a related follow-up, then jump back into the queue. Operator, we’re ready to take the first question.
Thank you. (Operator Instructions) And the first question comes from Bill Quirk with Piper Jaffray. Your line is open.
Great thanks, good afternoon everybody. Carl W. Hull: Hi, Bill.
Couple of questions, first of for Carl, how do we think about the chlamydia and gonorrhea business tracking as we go forward given at the clinical sales you know obviously has our handful know with not one but two new assets sale and how we just make sure these guys don’t take their eye of the target? Carl W. Hull: Well, it’s a good question, Bill. We clearly have deep relationships with our existing chlamydia and gonorrhea customers throughout the United States. They are precisely the same customers that we are going to selling HPV to the large part and I think the customer contacts will maintain their existing level and fact increase since we have more to talk about with respect to the HPV launch. So, I don’t see any risk there and you can continue to see that we’re gaining share in the space when we feel good about that.
Very good and then as a follow-up switched topics a little bit. Just thinking about dengue, Carl and how broad that could be. Obviously I would imagine that this would be broader than say just testing units coming out of Porto Rico given the how the national blood network works of units being originated in one part of the country shift and being shifted to the other. Are we looking at something that theoretically would be across the whole US blood supply would there be some efforts at regionalization can you shed a little light on that? Thanks. Carl W. Hull: Yeah. I do not think that it will be a nation wide type thing. Right now, dengue in (inaudible) is one in the Porto Rico and you see some evidence of it a longer real brand and obviously in South Florida, because of transport the people back in forth between those areas, but the fact of the matter is emerging pathogens like dengue and there are some other viruses like Chikungunya are really two tenth of a region in nature at this point and the appropriate screening for them is regional and at some degree may also be seasonal. So, I think we would moderate expectations for nation wide screening, but in areas where it’s endemic any blood that’s collected because of what you said and the packet it may move to other parts is likely to be subject to screening. Do keep in mind that we are going to be doing this all under IND. So it is similar to the experience with West Nile virus longer term of course other tropical countries around the world are affected by dengue in the fashion similar and so we would be looking long terms towards what the up tick in the markets might.
And the next question comes from Isaac Ro with Goldman Sachs. Your line is open.
Good afternoon guys. Thanks for taking the question. Carl W. Hull: Hi Isaac.
First on the women’s health initiative maybe if you could kind of give us a little bit of a picture around what that means on a dollar basis for incremental investment. You know the SG&A number was a little higher we would have expected but R&D is little lower, so they are more or less offset, but want to make sure remodeling the run rate on that initiative properly going forward relative to the other things that gone on. Carl W. Hull: I don’t think we have got a number in terms of specific percentage profile diluted towards one itself. We tend to group with the entire investment that we make and obviously you know that our partner Novartis does the SNM spend from much of that business. I would tell you that consistent with what we’ve said before we are increasing our investment in sales and marketing capabilities that you’ll see marketing related expenses around the launch of the new products that will be specific and dedicated to it probably one time in the sense of they are not going on for five years but they may extend over multiple periods, multiple quarters as we support the launch of HPV and then PANTHER, and the expansion that you will see overtime in S&M related headcount largely is related to services support headcount for PANTHER. We have a very detailed and very well thought out plan for how we will need to expand our geographic service capability and we will execute that and it’s going to be tightly titrate the two results and then we’ll have the (inaudible).
Great, thanks and then maybe follow up on PANTHER. Obviously, the situation in Europe is tough to call here in capital spending by most other companies in healthcare has really been somewhat constrained this quarter and tough to call going forward. How are you guy’s kind of putting air bars around your business plan in PANTHER for Europe over the next two to three quarters. Is there a wide range of outcomes you’re expecting or do you have a recently good view on what you think you can do in terms of getting that continued excess in that product launch? Carl W. Hull: Yeah, Isaac we are pretty pleased with where we are, with PANTHER right now in terms of unit placements and the funnel that we look at. As a reminder we focus really on reagent rental models so the availability of capital constraints on that is not really a significant factor for us. I think we’ve said before that in general, we would expect as much as maybe 10% of our placements to be capital that is very account dependent it’s not even country dependent just enter into the door they have access to the funds and they want to require the instrument that fashion but it’s not a period for us given the strength of our balance sheet.
And the next question comes from Dan Leonard with Leerink Swann. Your line is open.
Great, thank you. My first question on HPV, now that product is approved and you mentioned that you’ve begun your commercial activity. Can you comment on your pricing strategy and also what the margins will look like on that product compared to the balance of your portfolio? Carl W. Hull: Yeah, I will be happy to comment. I mean we are not going to get into specifics about the particular prices that we planned to offer in the market et cetera, but I would tell you that Gen-Probe has never been a company that’s needed to compete solely on the basis of price that’s because we have a differentiated product offering, we have automation that adds incredible value to our customers on work flow. So I think that you could expect us to maintain that philosophy as we price and think about the value of our HPV product offering, which is both the assay and the TIGRIS, and with respect to second part of your question, I think right now, our assumption is margins will be similar to our other amplified assets.
Okay. And then my follow-up, your 2012 guidance of low teens product revenue growth, is that organic? Michael H. Berrendorf: So, Dan it’s, Mike. Just to clarify we said low double digit product growth next year not low teens.
Okay. And that’s an organic number? Michael H. Berrendorf: It is.
Okay. Thank you. Carl W. Hull: You bet.
The next question comes from Quintin Lai with Baird. Your line is open.
Hi, this is actually, Julie in for, Quintin. Carl W. Hull: Hi Julie.
Hi, just a follow-up a little bit more on TREK. Last quarter you mentioned that you had 50 customers that were either currently using or validating the assay. Would you give us an updated number for that? Carl W. Hull: I'm not sure I have the updated number just because I haven’t seen them in the last couple of weeks. I think you could expect us to have increase the number of customers that we’ve approached obviously our entire universe of customers about it, but you would have seen in terms of the contribution to this quarter sales growth is those that that we were talking about last quarter some of them having adopted it. But I do not have a current number for you in terms of the number of accounts act.
Okay. So would you say that it’s been going relatively [minus] your expectations? Carl W. Hull: Oh yeah. Very much in fact. We are pleased with the performance of TREK the customer enthusiasm. We just see that it’s taken sort of between one and three months during the eval and validation timeframe from the point that people make decisions until they’re finally up and running.
Okay, great. Thank you. Carl W. Hull: You bet.
Peter Lawson with Mizuho Securities. Your line is open.
Carl, I just want to ask on HPV product and has there been any change from the go to market strategy for the US from what you may have learned from the European launch? Carl W. Hull: No, Peter, I don't think so. We certainly view the markets as being somewhat distinct from one another. At this point, we believe that the strength of the product’s performance and the specificity improvements that are seeing resonate extremely well with sort of three target audiences. One is, the national KOLs who drive guidelines, policy decisions and the heavily influenced, the decisions of others. Secondly, regional KOLs and senior physicians in different geographies in the United States, and then finally, the third group and very importantly is our lab customers, not that they necessarily have an opinion on the appropriate specificity of an assay, but more because they’re dealing with customer complaints from physicians when they have a high number of false positive HPV results, and they're looking for solutions to that problem.
Thank you. And then, just on the macro, the impact from layoffs at Novartis, did that impact or do you think that will impact Gen-Probe's business? Carl W. Hull: I don't have any reason to believe so, Peter at this juncture. All I heard and all we have seen is the macro announcement of a number, which I believe is around 2000. I can't recall exactly the Novartis is planning to trend. We have no further information beyond that. But I can tell you that the business is moving along well probably from the perspectives of both companies, so no reason to expect too much.
Your next question comes from Jon Wood with Jefferies. Your line is open.
Well, hey thanks gents. Hey, so I might be overstepping the boundaries here. But Herm, can you just give us a very kind of broad sense of next year on the margin side. There's a lot of moving pieces obviously in the P&L here and below the line for that matter. Can we expect the margins to be down or flat next year, just if you're willing to go into the initial view, we would appreciate it?
Yeah. Well, you might be a little bit Jon, overstepping. We're not going to give guidance on '12 until the time is right and that's going to be our year-end call.
Okay. But safe to say that you’ll say a little bit on R&D, you're building out the commercial infrastructure. So any movement above the line or will be most likely a gross margin phenomenon. Is that an accurate?
You know we're just not going to get into that right now, Jon. But we will give you plenty to work with. Just stay tune.
Our next question comes from Tycho Peterson with JPMorgan. Your line is open. Tycho W. Peterson: Hey, good afternoon. First one on HPV, Carl in your comments, you talked about labs effectively doing HPV and Chlamydia, gonorrhea of this the same sample. To what extent, do you think you will see bundling here? And then, how should we think about HPV potentially driving additional TIGRIS placements further down the road? Carl W. Hull: Tycho, I want to ask Eric to comment a little bit on that.
Sure. So hey Tycho, it's Eric. So I think first of all, what we're seeing is obviously a lot of overlap in the TIGRIS base between our Chlamydia, gonorrhoea and our HPV customers. And so we're going into this market with the advantage of having TIGRIS is in virtually large number of accounts that are already doing HPV testing. To the extent, that there’s going to be bundling there, certainly we are going to be looking at the entire book of business with our accounts. So we intend to present the compelling case. We’re not in the business of competing on price, but certainly, the CT/GC business that we have in place does give us a leg up with those accounts. Tycho W. Peterson: Okay. And then to the question I understand you want to say a lot about 2012. But as we think about R&D, is there a tail on HPV here where you got to do kind of follow-up studies and should we think about R&D potentially being flat on a go forward basis. How do we take about your ability to control some of the R&D costs? Carl W. Hull: Yes, Tycho. I think it is important to emphasize that our HPV trial is ongoing in actually last three years after the conclusion of the first trial. So we've got a couple of year tail still in front of us from where we are and we’re following up on a very large number one. So it’s (inaudible) giving at some senses. As we think about R&D overtime, we really have a lot of product development opportunities in front of us and we see PANTHER as being the platform that’s going to deliver and actually generate the revenue associated with new opportunities. So I think we call out for you the viral load development effort and recognize that that's going to be a significant part of our product development portfolio in 2012 and in 2013.
The next question comes from the Ashim Anand with Natixis. Your line is open.
Thanks guys. Congrats on HPV approval. Carl W. Hull: Thanks, Ashim. Appreciate it.
I was wondering, you guys have talked about the installed base for CT/NG, if you can again, comment on that installed base in US, what percentage are actually currently doing HPV testing?
Yeah. I think we can tell you that. Obviously our installed base in diagnostics is focused on women's health and out of our TIGRIS base, the vast majority of those accounts are also doing HPV testing. Carl W. Hull: And we have greater than 200 diagnosed TIGRIS in the United States.
Okay. In terms of the differentiation your APTIMA HPV test has, in terms of that pathogenesis of cervical cancer. I was wondering if there would be a little bit different marketing campaign for HPV like more sort of the pulling campaign direct to customer that has positioned sort of things, so that the physicians can actually appreciate the differentiation in pathogenesis and what role APTIMA plays. Is that something like that under a plan in terms of marketing? Carl W. Hull: Well, there's two elements, if I understood it your question correctly Ashim. The first is, did you see? And the answers, no, we don't anticipate that and don't feel that’s appropriate in this case. It’s fairly important and fairly sophisticated to sell, which you need to make and that's probably not – that’s on to consumers. The second one in respect to physicians, we certainly will talk about as we do our physician education work, the reason why we are more specific that is fundamentally, in fact, we're dealing with messenger RNA and it's a better indicator of active infection and that active infection that’s going to lead to cervical cancer. So that is a key part of the marketing message.
The next question comes from Jon Groberg with Macquarie Capital. Your line is open.
Hi, thanks for taking the questions. It seems like on the blood screening business obviously it’s been a little bit of choppy year, but it sounds to me though in your conversation with Novartis that you are getting a little bit more visibility in terms of what’s happening. So one maybe, you can just say whether or not that is true or not, and if it is as you think about 2012, I know you get the 1% step up in the royalty rate. But if you guys think about kind of the underlying growth of the testing market itself, do you see any reason for that to change in 2012? Carl W. Hull: Yeah Jon, both good questions. I think the answer is no, we don’t see any reason for a change in the current expectations, the experience that we’ve had to date shows the market as being stable and shows those maintaining if not gaining share fractionally on an ongoing basis. So we are pleased with that, we do have I think an improved working relationship with Novartis. We are getting greater visibility into what’s going on and I mentioned the example of the Joint Symposium we sponsored with them at the AABB, and we’re in close contact with key customers at Novartis’ direction and request in order to talk both about product development opportunities as well as the new instrumentation. So I think also, we still feel very good about the blood screening business. We see the underlying dynamics being fairly consistent with what you’ve seen for the last few quarters.
And if I could, just one follow-up, obviously you had Roche and their HPV test approved and they have been very aggressive in trying to market it in Qiagen, being aggressive trying to defend its share, you made the comment that it takes time and money and to get some tractions. How long do you think it will take you to have real traction with HPV? Carl W. Hull: Well, we certainly have pretty high expectations of our team and our capabilities, but time will tell here. I think if we look at the comparable experience probably if you look at Hologic and the introduction. So I think that well about 2.5 years ago various estimates suggest they are around 10% market share currently. I would tell you that our expectations would be that we can certainly at least do that in better, because of the fact that we have both the differentiated assay offering, but more importantly we’ve got the automated solution and speaking candidly, if you look across Hologic, Qiagen and Roche, none of those three guys is good as they maybe have the automation that we (inaudible).
The next question comes from Doug Schenkel with Cowen. Your line is open.
Hey good afternoon guys and thanks for taking my questions. Carl W. Hull: Hi Doug.
In our industry checks with hospital CFOs, we continue to hear about increased focus on the evaluation of bringing back tests in-house versus sending out to reference labs. Of the few hundred instruments you have in the field, how many do you believe are at institutions where HPV tests are currently being sent out and accordingly how aggressive do you think you could be in making the economic argument to existing customers that they shouldn’t send out, but they should keep these tests in-house. Carl W. Hull: That’s a good question, I don’t think we have a ready answer for you in terms of proportions or could give any granularity on numbers that will help you, Doug. I would just say that we have talked about our STD business in the United States being divided among three customer segments Public Health being the smallest on a proportionate basis and Reference Labs and Hospitals being the large two segments. So we’ve got boxes in place in a large number of hospitals today. I can’t give you any feedback on how many of those guys are not doing HPV base testing because they are sending it out. But certainly that’s going to be part of our discussion with every existing TIGRIS hospital as out there and then over the long-term couple three years out as we have HPV on PANTHER that becomes even more wide spread discussion.
Okay thank you for that. One somewhat related follow up, you talked about how in most areas where you previously or currently compete you haven’t have to lead with price, you haven’t have to be aggressive with price. But I think we all recognize at this point now Roche, there is Hologic, you guys and of course Qiagen on the market and there is of course others planning to come to the market over the new few years in HPV. Why wouldn’t price become more of an issue here for you and for other players? Carl W. Hull: Good question Doug. I think prices obviously always relevant in the discussions. I think it really were reflecting more relative price philosophy, market prices will be, what market prices would be but we think in any circumstances we’re contributing more value by the capabilities of our automation and the performance in this case of the HPV assay. So I don’t expect those to change our philosophy obviously we found price being a significant barrier, in our launch plants, we would reevaluate that.
Okay thanks again. Carl W. Hull: You bet.
The next question comes from Brian Weinstein with William Blair. Your line is open.
Hi, thank you very much. Carl W. Hull: Good morning.
Hi, guys. I think we’ve already discussed this at one other time, but I just want to make sure that every one is clear on this. It appears none of the current guidelines mentioned are they testing anywhere in their management recommendations and that the major policies specified DNA testing and not RNA testing. How much of an issue is this (inaudible) that is out there at this point. Carl W. Hull: I think your later characterization is the right one Brian, you know people refer to HPV DNA testing because that was the only way you refer to, but it was the only thing that was there what we’ve demonstrated is our ability to clear through the FDA and improve really next generation of HPV assays and we don’t see the things which we are asking about being there.
Okay. So you don’t think that you’re going to have to [got only] the payers and have them actually change anything before you can actually get any kind of reimbursement? Carl W. Hull: We don’t believe so, if but we’ll have all the necessary reimbursement discussions as we go on.
Okay, great. Thank you. Carl W. Hull: And Crista, could we have time for one more call it looks like.
Last question comes from Steve Unger with Lazard Capital Markets. Your line is open.
Hi, good afternoon. Thanks for let me ask question. Carl W. Hull: Hi, Steve welcome
Thanks. I just want to understand your expectations for the blood screening business in the fourth quarter. Are you guys expecting to get back up into the $200 million revenue range for the year. I guess it’s over $60 million in the fourth quarter? Carl W. Hull: Herm, you want to take it?
Yeah. I mean we haven’t gotten into that much specific but what we have said is that you know the assay levels would return to more normal levels and we have just a bunch of instruments going to them in the fourth quarter. So I think you can expect to see the kind of growth we laid out in our guidance.
Okay, great. Carl W. Hull: So obviously the mid point of guidance implies something like 20 million of increased quarter-over-quarter, we can certainly say that the vast majority of that would be blood screening.
Got it. And then just as far as blood screening assay sales year-over-year, year-to-date has that grown for you is it more TIGRIS placements that in blood screening that is down year-over-year? Carl W. Hull: Yes, that is exactly right. The assay business has been stable overall when you look at the in donation data and the instruments have been a major source of fluctuation absent the supply chain issues you talked about last quarter. Carl W. Hull: Okay. So thank you all very much for your questions. I’d like to wrap up just simply by saying the Gen-Probe’s third quarter financial results were in line with our expectations overall and we remain excited about our pipeline especially with a recent approval of our APTIMA HPV assay. Before we sign off, let me remind you that our prepared remarks will be posted on our website momentarily, and we encourage you to refer to them if you missed a fact or a number during the call. Thanks very much for your time and attention today and please call us, if you have follow up questions.
And this does conclude today’s conference. Please disconnect at this time.