Earnings Labs

Qiagen N.V. (QGEN)

Q1 2014 Earnings Call· Wed, May 7, 2014

$34.04

-10.65%

Key Takeaways · AI generated
AI summary not yet generated for this transcript. Generation in progress for older transcripts; check back soon, or browse the full transcript below.

Same-Day

-0.39%

1 Week

+0.39%

1 Month

+4.49%

vs S&P

+0.39%

Transcript

Operator

Operator

Ladies and gentlemen, thank for standing by. I am Patrick Wright, your Chorus Call operator. Welcome, and thank you for joining Qiagen's conference call to discuss results for the quarter 1 of 2014. [Operator Instructions] Please be advised that this call is being recorded at Qiagen's request and will be made available on their Internet site. [Operator Instructions] At this time, I would like to introduce your host, John Gilardi, Vice President of Corporate Communications at Qiagen. Please go ahead.

John Gilardi

Analyst

Thank you, Patrick. Good afternoon, and welcome to our conference call today. Our speakers are Peer Schatz, CEO of Qiagen; and Roland Sackers, our CFO. A copy of the announcement and presentation for this call can be downloaded from the Investor Relations section of our website at www.qiagen.com. On Slide 2, you'll see the customary disclaimer. The discussion and response to your questions on this call reflects management's views as of today, May 7, 2014. Today, we will be making statements and providing response to your questions that state our intentions, beliefs, expectations or predictions of the future. These constitute forward-looking statements for the purpose of the Safe Harbor provision. They involve risks and uncertainties that could cause the actual results to differ materially from those projected. Qiagen disclaims any intention or obligation to revise any forward-looking statement. For more information, please refer to our filings with the SEC. I would like to now hand over to Peer.

Peer M. Schatz

Analyst

Thank you, John. Hello, and welcome to our call today to discuss our results for the first quarter of 2014 and the progress we are making to accelerate innovation and growth. We have a lot of news to share with you today. First, on the results, adjusted net sales were up 5% at constant exchange rates, which was in line with our communicated full year 2014 target for 4% to 5% constant exchange rate growth. Excluding U.S. sales of our HPV test or human papilloma virus test used for cervical cancer screening, our portfolio grew about 9% constant exchange rate growth. Adjusted operating income grew 7%, and adjusted EPS of $0.22 per share was in line with our target as well. We're making progress on delivering important regulatory approvals and new product launches, especially among the 5 growth drivers. We are pleased to announce the FDA clearance of the full QIAsymphony RGQ MDx automation platform and the clearance for the C. difficile assay for detection of this life-threatening infection. We're working on up to about 10 additional U.S. and European submissions this year. Another is the China approval and successful launch of the QuantiFERON latent TB test. Our bioinformatics solutions, such as the new CLC Cancer Research Workbench, are delivering the data analysis and interpretation needed to make sense of complex data; and the new universal pre-analytics, such as the REPLI-g Single Cell Kits, are improving access to nucleic acids in challenging biologic samples. On GeneReader, our teams have been making progress in addressing the challenges to developing this NGS bench-top workflow into a complete sample-to-insight system, targeting the needs of customers in clinical research and diagnostics. Market entry is expected in 12 to 18 months, and the initial focus will be partnering with customers in biomedical research, clinical research…

Roland Sackers

Analyst

Thank you, Peer. Good afternoon to everyone in Europe, and good morning to those joining from the U.S. I'm on Slide 6 and would like to review our results for the quarter. Adjusted net sales were $317.4 million, rising 5% at constant exchange rate and also on a reported basis. We saw some currency headwind from the Japanese yen and various emerging market currencies in the first quarter, but this was largely offset by strong euro-denominated sales. About 3 percentage points of growth came from the Ingenuity and CLC bio acquisition and about 2 percentage points from the rest of the business. And remember that results include about 4 percentage points of headwind from declining HPV test sales in the U.S. Even with lower HPV sales, the adjusted gross margin remained steady at about 72% of sales. We are seeing a shift towards more consumables, and the expansion in bioinformatics, which has gross margins well above the company average and is also supporting this trend as well. Adjusted operating income grew 7%, at a faster rate than sales. R&D investments were higher as a percentage of sales in the first quarter of 2014 compared to the same period in 2013, but we achieved margin gains in sales and marketing and also in general and administrative expenses. So these are signs of benefits from our productivity initiatives. As a result, the adjusted operating margin improved by about 60 basis points and was about 24% of sales. Adjusted net income rose at an even faster 12-percentage pace, and the $0.22 of adjusted EPS and the tax rate of 22% were both in line with our goals for the quarter. In terms of adjusted EPS, we did not see any meaningful net currency impact in the quarter, but we still expect a potential…

Peer M. Schatz

Analyst

Yes. Thank you, Roland. I'm now on Slide 11 to provide an update on the progress we are making on strategic initiatives. Our strategy is anchored on expanding our leadership in sample and assay technologies that address the rapidly evolving needs of customers to transform biological samples into valuable molecular insights. These 5 growth drivers are addressing the critical needs of customers across all of the classes as we help drive the dissemination of molecular technologies. Here are points to consider on the growth drivers. The QIAsymphony automation platform is expected to provide about 1 percentage point of incremental sales growth in 2014, and new longer-term impulses are coming from the recent FDA approval of the full workflow and plans for many new test submissions. QuantiFERON is set to break through $100 million of sales in 2014 and could surpass the size of our U.S. HPV franchise. We see enormous growth potential ahead, given that modern latent TB testing is only about 10% penetrated and the total addressable market is estimated at $1 billion. Personalized Healthcare is generating more than $100 million of sales and growing at a good pace, with expectations for higher kit sales and revenues from the companion diagnostic co-development agreements in 2014. Bioinformatics is set to be an important incremental contributor this year as well, as we create an industry-leading portfolio anchored by the combination of teams and products from Ingenuity, CLC bio and Qiagen. And on NGS, we are launching a series of new sample technology kits, as well as expanding our offering in bioinformatics. Together, we see these activities as having well above $50 million of annual sales and strong growth. Qiagen continues to be the unrivaled leader in sample technologies inside next-generation sequencing labs. And here, we mean extracting valuable DNA and RNA…

Roland Sackers

Analyst

Thank you, Peer. I'm now on Slide 17 to review our guidance for the second quarter of 2014 and our reaffirmation of our full year guidance as well. As you know, a new adjustment policy took effect with the first quarter of 2014. First, share-based compensation is included as a cost in adjusted results. Second, costs for restructuring are only adjusted when related to business integration and acquisition-related activities. The comparable figures for 2013 are provided in the appendix of this presentation. In terms of guidance for the full year, as mentioned earlier, we continue to expect total sales growth of about 4% to 5% constant exchange rate. This includes a headwind of up to about 4 percentage points for the declining U.S. HPV test sales and for the rest of the business to grow about 8% to 9% constant exchange rate. Adjusted operating income is expected to grow faster than sales and generate at least 100 basis points of adjusted operating margin improvement. We also continue to expect adjusted diluted earnings per share of approximately $1.07 to $1.09 for full year 2014 compared to $1.02 in 2013. Also, I want to note these expectations do not take into account any acquisitions that could be done in 2014. We have given this target for adjusted EPS at constant exchange rates since we continue to see the risk for an adverse currency impact on earnings due to the volatility of some currencies against the dollar. In the first quarter, the stronger euro and British pound essentially netted out the adverse currency impacts of about $5 million on sales in countries where we have a low-cost basis. This includes Japan, Turkey, Brazil and Australia. You can find this information in the appendix to the slide deck. For the second quarter of 2014, adjusted net sales are expected to rise about 4% constant exchange rate, and we expect about $0.24 to $0.25 of adjusted EPS and -- also at constant exchange rates. We have a cautiously optimistic outlook for the second quarter as we look for increasing contributions from our 5 growth drivers. We are also monitoring trends in the life science market, particularly in Asia and the U.S. and have not changed our views on U.S. HPV trend. This slide also contains assumptions for adjustment to results for the second quarter and the full year. For the full year 2014, we expect about $120 million for amortization of acquired intellectual properties, about USD 10 million to USD 15 million for business integration and acquisition items and an adjusted of tax rate of about 20% to 21%, and this is slightly higher than the earlier estimates of 19% to 21% due to the convertible bond transaction. With that, I would like to hand back to Peer.

Peer M. Schatz

Analyst

Yes. Thank you, Roland. I'm now on Slide 18 for a quick summary before we move into Q&A. We're off to a solid start in 2014 and delivered on targets for higher sales and earnings. We're moving ahead on initiatives to accelerate innovation and growth while also increasing returns to shareholders. Let me review what we have announced. We achieved our targets for the first quarter with our broad portfolio growing at an underlying high-single-digit constant exchange rate growth against the expected weakness in U.S. sales of HPV test. Our 5 growth drivers are gaining momentum. We have made significant progress with the FDA clearance of the full QIAsymphony automation platform and plan for many new test submissions. We're signing new co-development agreements and launching new technologies with Exosome sample kits to gain access to valuable molecular insights in Personalized Healthcare. We're also driving the expansion of QuantiFERON latent TB test in key markets and are now entering China, a very attractive opportunity. And we're developing our capabilities in bioinformatics and next-generation sequencing technologies. Our portfolio of universal solutions is addressing key challenges to adoption of NGS technologies, particularly through products to improve access to challenging biological samples, as well as cutting-edge bioinformatics applications to help customers make sense of the massive amounts of data being generated. In closing, based on the start to the year, we are well positioned to achieve our goals for 2014. And with that, I'd like to hand back to the operator to open up the Q&A session. Thank you.

Operator

Operator

[Operator Instructions] And our first question today comes from the line of Daniel Wendorff of Commerzbank.

Daniel Wendorff - Commerzbank AG, Research Division

Analyst

Daniel Wendorff, Commerzbank. Two, if I may, starting off with next-generation sequencing. And there, my question would be how do you see the takeup of your sample preparation solutions in light of the GeneReader not yet being available? I know you mentioned in the presentation that they can basically be used with any sequencer. I'm just curious to know how this would work in terms of marketing. And, yes, how do you see the takeup there? Second question would be, looking at your planned submissions of diagnostic tests in 2014, what would you consider the most important one in terms of the commercial opportunity?

Peer M. Schatz

Analyst

Thanks, Daniel. Good questions. First on universal next-generation sequencing and the market opportunity, today, if you look at the workflows in next-generation sequencing, they are quite fragmented. So to go from a raw biological sample through to a report, there are actually multiple, multiple different steps today, sometimes anywhere between 10 and 15 hours of hands-on time, a very complex workflow involving many different sub-modules that typically are also supplied by different parties. Very few people actually use larger stretches of solutions provided by any one player. So if you look at sample technology space, which is often mistaken for the sample preparation, sample technologies is the step in which you go from raw biological sample to purified nucleic acid, and there, we have an overwhelming market share. In terms of presence in next-generation sequencing lab, I think we have the highest market share of any company in laboratories in terms of those workflow steps. This is a very critical front-end step that involves very specific protocols, often targeted and optimized and very often validated over years of publications and experience. So the classical sample technology area, where Qiagen has a very, very strong domain strength, is one where we have overwhelming market shares, very often 80%, 90% or in some cases, even more. This is an area where we have an unrivaled leadership as well. And if you go into any laboratory conducting next-gen sequencing, you will typically see our solutions running for that step. The panels that we launched, the first version last year and the second version actually coming this year, have gotten some very good uptake. We've seen the first publications come out showing superior performance of these panels that include the combination of specific gene tests into next-generation sequencing panels in a very, very fast…

Operator

Operator

And our next question comes from the line of Tycho Peterson of JPMorgan. Tycho W. Peterson - JP Morgan Chase & Co, Research Division: Following up on GeneReader, Peer. I'm just wondering if you can maybe elaborate on the new timelines. They've slipped a little bit relative to, I think, our prior expectations, for something in the back half of the year. And you did call out some system integration and other issues in the press release. So wondering if you can elaborate on that. And then, secondly, for Roland, the x HPV growth rates were again robust, but I'm just wondering if you can call out the profit contribution from U.S. HPV, both in terms of gross and operating profit just to put it into context on the bottom line.

Peer M. Schatz

Analyst

Sure, Tycho. I'll talk the first one; Roland, the second. So first, we all know next-generation sequencing is a pretty dynamically moving area. And in terms of GeneReader, we have refined specifications on the GeneReader system and thereby, adjusted some of our chemistries and other components in our sample-to-insight workflow. This has pushed out timelines, the systems integration and with that, the design lock and therefore, the overall timelines. We are committed to the basic design targets, so the targeted applications in clinical research and diagnostics and the platform technology. So we do expect to provide a good return on this investment. And as with all of our R&D programs, we monitor the value-creation potential on a constant basis.

Roland Sackers

Analyst

On the second question, Tycho, as you know, HPV clearly still has a very nice gross margin. Nevertheless, it is also product which, as you recall, has still a quite significant operational expense linked to it. It's the only product within our organization which really has 2 different sales organizations. And therefore, I would say the overall EBIT margin contribution is probably even slightly below our company average these days. And that was something also much kind of quite nicely reflected also in the first quarter results. But despite the quite significant decrease we have seen in our U.S. HPV revenues, we were able to increase our gross margin in the first quarter, especially driven by a very small bioinformatics business, which also comes in with a very nice gross margin improvement in our QuantiFERON operational capabilities. Those are a couple of things which are very helpful. And also, the efficiency programs, which we were able to conclude last year, showing no adverse impact throughout the year, 60 basis points margin improvement. They are coming in from a couple of different factors and helping us, again, even with a quite significant headwind we have in HPV, to improve our margins. That's also something that we believe should be doable but are not [ph].

Operator

Operator

And our next question comes from the line of Scott Bardo of Berenberg.

Scott Bardo - Berenberg, Research Division

Analyst

The first question actually just following on, on GeneReader, please. Can you just help us understand a little bit more whether the slight pushback in the timeline was more related to you increasing the functionality of this system or it just relates to some integration hiccups or problems that you haven't anticipated? So just perhaps a little bit more visibility there. And if this project fails in its entirety, can you give us some sense of where you think you can take your next-gen business today and into the future? And perhaps even if you can quantify that, that would be very helpful. And the second question just relates to your refinance. Obviously, some very impressive low interest rates, quite a bit of cash now sitting on the balance sheet for QIAGEN. Are we to assume that any acquisition that you make, be it this year or next year, is likely to be earnings-accretive, given this super low interest rates that you now have? So perhaps, if you can answer those 2, and I have a follow-up.

Peer M. Schatz

Analyst

Sure. Scott, I'll take the first question and hand the other -- the second one to Roland. So first, in any development project, you clearly have technical challenges in the systems integration phase. But in this project, it was combined also with our wish to upgrade some of the specifications and make them more amenable to a better profile of the product overall and also better economics. So these 2 things are very difficult to separate out. We are seeing such good success on the universal portfolio currently, such good uptake, that our teams are very focused right now and just making sure we have an almost ubiquitous presence with these universal capabilities before we focus too much on a specific segment of the market. So from that perspective, next-gen sequencing is an important integral part of our vision going forward. The availability of a system is certainly part of the plan going forward, and we're on track to get there. It isn't pushing back our ability to build presence in this market. And probably even more so, as we have now universal approach, that will allow us to address any customer regardless of the platform that they currently have. Roland?

Roland Sackers

Analyst

Yes. On your second question, the refinancing, the issuance of new convert was really not linked to any potential M&A thoughts we had. I think we had 2 major goals here. And the first goal was, first of all, taking off the potential risk of another 50 million shares dilution with an increasing share price going forward and at the same time, of course, securing a very attractive mid- to long-term debt financing at these very attractive [indiscernible], as I said before. So it was really our 2 focuses [indiscernible] the refinancing. At the same time, we clearly see bolt-on, probably small acquisitions in certain areas as part of our strategy. At the same time, we see that our organic growth rate is clearly accelerating and the 5 growth drivers are moving in the right direction. So I think a combination of those is what we had in mind

Scott Bardo - Berenberg, Research Division

Analyst

But it's difficult for you to say whether those bolt-ons will be earnings-accretive at this stage?

Roland Sackers

Analyst

It's clearly the goal to make value-enhancing deals. There's no question on that. And I would say, if you look back towards the recent additions and acquisitions we made, they are all quite attractive to Qiagen, and I think we clearly keep it a goal. But again, focus #1 is organic growth.

Scott Bardo - Berenberg, Research Division

Analyst

Understood. And just last question, please, if I may. Peer, just wondering if you could share some thoughts on primary screening in the U.S. for HPV overseas [ph]. One of your competitors has had some success with that claim [ph]. Just wondering whether you think that heightens the competitive pressures in the U.S. or are you relaxed?

Peer M. Schatz

Analyst

Sure. Well, as you know, we've been in the U.S. HPV market for years. This is a co-testing market where Pap and HPV tests are often done simultaneously, and we see that continuing into the future as well. At the same time, our Qiagen solutions are approved for primary screening in many countries. And that means, in those countries, our Hybrid Capture 2 test is used as the primary test, often in stand-alone settings. The primary screening approach has been used in many markets, like the emerging countries which did not really have a lot of cytology testing in the past. And in those markets and also in first world countries, we have been the leading solutions in these markets. And there, for primary screening what is really interesting is that we have, by far, the most sleek and fast workflow. It is a fast workflow, and we have outperformed the competition significantly in terms of the clinical profile. This is confirmed by the fact that we've been winning almost all primary screening tenders and have not lost any significant tender. Turning back to the U.S., a competitor product recently received FDA approval for primary screening, but we do not really anticipate any real impact. This test has very poor clinical results in several studies where primary screening was used, including 1 in Denmark, where Qiagen showed far better results. FDA approval is -- does really not mean adoption. The guidelines do not support primary screening nor is reimbursement in place. And even if that changes, the system cannot deal with it well. So getting this approach to get some traction will take a lot of time and money and effort. The Pap test has been simply been around forever, and the amount of data needed to convince docs to use this alternative test is extremely high, also considering that there's a significant economic disadvantage to the primary screening method for them.

Operator

Operator

Our next question comes from the line of Isaac Ro of Goldman Sachs.

Isaac Ro - Goldman Sachs Group Inc., Research Division

Analyst

Roland, I want to ask just a question on margins. I think earlier, in the last quarter, you talked about a little bit of opportunity to consolidate facilities. And I was wondering if you could maybe provide an update on that process. And any sense -- will that actually help gross margins this year? Just wondering what's baked into your expectations in your guidance for gross margin tied to that specific initiative. And then second question will be just on pacing for free cash flow over the balance of the year. Any specific guidance that would cause free cash flow volatility over the balance of the year? Just want to make sure we model that right.

Roland Sackers

Analyst

Yes, sure. Let's start with the free cash flow question. We really have seen, in the first quarter, similar numbers than last year, but that still included this $9 million, $10 million payout for restructuring charges incurred in 2014 (sic) [ 2013 ]. This is now fading out, and that's clearly helping us by increasing our cash flow for the year. Nevertheless, I would say that a much more bigger driver over the course of 2014 in helping us to improve our cash flow is operating efficiency. We were able to gain and implement, I would say, over the last 12 to 18 months. So we expect still a quite significant ramp-up in terms of cash flow for the year. And as I said, it's clearly a larger number than we expect from the net income side. The cash conversion rate is going to increase. In terms of overall margin improvement, gross margin, clearly, in the first quarter had trended in the right direction. As I said, bioinformatics and as well [indiscernible] were quite helpful. At the same time, you have to have in mind that the first quarter is typically an instrument quarter where the percentage of revenues coming from the instrumentation business is the lowest one. So obviously, still increasing instrumentation business and moving through the year 2014, it is clearly to [indiscernible] the gross margin expansion. So all in, you probably will see gross margin around what we have seen now in the first quarter. Mid to long term, it's going in the right direction. We have to go through 2014 and eat up the impact on the HPV franchise in the U.S. Once we have included it in our baseline, I think, there's room for more. On the operational efficiency, with R&D, again, the first quarter was slightly above 12% of overall expenses. For the rest of the year, we still believe a number around 12%, somewhere between -- around 12% is probably a fair representation. On the SG&A, you will see also the benefit on the productivity and efficiency gains we were able to make over the course of 2013. So that's 100 basis points margin improvement. [Indiscernible] we were able to close on [ph] a couple of the smaller sized, but mostly, as I said, done already in 2013. So we will see the impact now over the course of 2014 helping us also on the productivity [ph].

Operator

Operator

Our next question comes from line of Romain Zana of Exane.

Romain Zana - Exane BNP Paribas, Research Division

Analyst

Two, if I may. The first one regarding the R&D investments. They have increased substantially in Q1. And I can see from the presentation, at the end of the presentation, that the number of employees working in R&D has also risen by 11%. Is that purely related to NGS? And what will be your fair assumption for R&D as a percentage of sales looking forward? And I have another question left.

Peer M. Schatz

Analyst

Thanks. Roland, do you want to take that one?

Roland Sackers

Analyst

Yes, sure. Actually, it's mainly related to our bioinformatics franchise. So the increase in terms of headcount is coming mainly from those investments we make in bioinformatics. NGS was already in the baseline position, no significant increase so far in 2014. We also expect that in 2014 we feel very well [indiscernible] with the investments we made there. Bioinformatics, right now, of course, is an area which shows as well a significant growth and opportunities and leverages [ph] the recent acquisitions we made. You'll see it also reflected in both R&D spending and as well in headcount.

Romain Zana - Exane BNP Paribas, Research Division

Analyst

Another question, maybe a bit more technical regarding your 401s [ph] for -- on the EPS guidance. You left the EPS guidance unchanged for 2014 despite the new share buyback program. It is linked to higher-than-anticipated issuance of share in the meantime? Or was the share buyback already assumed in your initial guidance?

Roland Sackers

Analyst

No, but a very good question. So we still have to finalize our share buyback program. I think, right now, we still have outstanding around USD 20 million to buy back under the second program. And then we'll probably start, I guess, in the second part of the year, with the third program. Based on limitations we do have in Europe in terms of volume we can buy back on a daily basis, I think it would take some time. So it's quite minimal impact from the share buyback. And then on a 6-month period, we will see how quickly we get it done. It's always a volume number over the course of 2014. Have in mind also, the second and the first one took us a couple of months. So for 2015, a larger impact, not material for 2014.

Operator

Operator

Our next question comes from the line of Vijay Kumar of ISI Group.

Vijay Kumar - ISI Group Inc., Research Division

Analyst

Maybe just -- I had one for Peer. And a lot of moving parts in the Pharma. It was good to see some strength in that segment. Obviously, given some of the consolidation comments that you made, creates a little bit of volatility. But also, I guess, offsetting that, if you look at some of the acceleration on the companion diagnostic side, the strength you're seeing, I think, some of the comments you made on liquid biopsy, it feels like things are actually picking up on the Pharma side. So can you just elaborate on those comments in consolidation? Compare and contrast that versus the companion diagnostic acceleration that you're seeing.

Peer M. Schatz

Analyst

Sure. Thanks, Vijay. It is definitely quite impressive to see what we have been able to put together in the pipeline. The numbers that we put up out on that 1 slide, we actually put out for the first time. The momentum in this area is very significant. It's a sizable team that we currently have, and they are basically initiating partnerships and managing partnerships across multiple different platforms, primarily PCR and NGS and across multiple indications. Cancer is clearly a big one, but we're also seeing others as well. The pharma consolidations can have a benefit and a disadvantage. So the benefit is if you merge us into parties where you have master collaboration agreements, it's a big benefit. And we've been fortunate partly to see that and therefore, have a promising outlook also on some future pipeline expansions going forward. But on top of that, the fact that we have now multiple products in the market, and as you know from the pipeline, there's some near-term submissions as well over the course of the next 12 to 18 months, we're going to see more momentum. And these are things that are attracting pharma companies that this is an actually very doable thing for us to do across multiple different testing technologies. And so momentum, as the 1 slide shows, 10% to 15% of the trials included biomarkers 10 years ago, now 45%. And that puts us into a very sweet spot. And we're the only company that has all technologies molecular under 1 roof and also has gone PMA routes and have done so successfully. And that always takes a few years to prove to the market, and we've gone through that phase. And I think those things coming together put us into a good position. I don't expect it to stop. We expect also continued very good inflow of these partnerships.

Operator

Operator

Our next question comes from the line of Derik De Bruin of Bank of America.

Derik De Bruin - BofA Merrill Lynch, Research Division

Analyst

Just one quick one and then a follow-up. Just, Roland, can you just give us -- can you quantify the HPV hit to the gross margin?

Roland Sackers

Analyst

As we said, it's down -- you can do the math. It was down in the U.S. 27% and now it's 9% of total. And gross margin is still in the mid-80s [ph].

Derik De Bruin - BofA Merrill Lynch, Research Division

Analyst

Okay. And I guess on the QIAsymphony and sort of looking at the C. diff approval. So I guess, how does this work? I mean, are -- do you have to go back and retrofit your current industry installed base for the QIAsymphony to get it -- basically, get it up to spec for what the FDA approval was on it? And do you have to do any changes to the installed base to make it compliant? And I guess on the -- when you think about the C. diff test, I mean, where are you expecting to go -- into what types of labs are you expecting to go into? And what are those labs currently testing for and currently using for C. diff? Are they more immunoassay test? Are they more molecular tests? And I'm just curious to think of how you think about taking share and moving to gain share in the C. diff space?

Peer M. Schatz

Analyst

Sure. Well, again, C. diff is a single marker. It's the same path, but if you think of this as a complete portfolio across HAI, it is a pretty powerful proposition. The availability of a broad menu makes it very attractive to laboratories that are providing a wide range of different tests, in particular, in hospitals. The ability to do random-access continuous load testing gives it some very unique features, low cost of capital, very broad menu but still allows quite a sizable throughput of testing at a very attractive cost. So it is a classic medium throughput hospital market testing machine for these hospital-acquired tests. It can also serve as a higher throughput base machine. We've seen also some demand coming in there with some of the more expensive neuro patient tests are simply done a little bit further out towards the patient, but the central laboratory takes a strong role in providing these tests in a centralized format, which is very often in the hospitals and also other types of health care settings, quite an attractive proposition. Some labs are actually doing very high throughput testing even with C. diff. And the systems that are out there or the QIAsymphony RGQ system that we now got FDA clearance for is identical to the systems that we have out there in the market, with the exception that, in some cases, the cycler would need a software upgrade and -- to reflect the newest version of the software that was included in the clearance. So it's quite an easy migration path that can be performed.

Operator

Operator

Our next question comes from the line of Zarak Khurshid of Wedbush Securities.

Zarak Khurshid - Wedbush Securities Inc., Research Division

Analyst

First, on the NGS business. Just digging into that $50 million revenue number that you've mentioned. If you stripped out the plain vanilla extraction, can you speak to the run rate of the NGS prep kit business?

Peer M. Schatz

Analyst

The run rate, well, we said $50 million as an overall number at high growth rates, so those are the 2 variables that we put out. I didn't quite understand what you wanted to get in addition to that.

Zarak Khurshid - Wedbush Securities Inc., Research Division

Analyst

Just the NGS prep kits' targeted -- prep and the things that launched more recently, I'd love to understand kind of the traction there and kind of the growth rates.

Peer M. Schatz

Analyst

Okay, sure. So when we talk about sample preparation in NGS, and I'd like to reiterate that and use this opportunity, that very often is mistaken for the sample technologies as we described. And so the preparation from a raw biological sample into purified nucleic acid, what we described sample technologies, is not sample preparation for NGS. What typically is described as sample preparation for NGS are then the steps downstream, so the target enrichment, the library preparation into sequencing. And on that front end, it is very sizable. On the sample technology side, even though it is only 1% to 2% of the biological samples that we process, the majority are other types of downstream analytical techniques, that area is one where you typically have higher-cost product because you're working clinical samples or ones that need very a high-quality front-end sample technology. In terms of the enrichment panels for NGS and also in terms of library preparation, we started ramping up in '13 and are now significantly expanding in this quarter in '14, with the 2.0 [ph] panels that are coming out, and they really have some very, very unique features. This is a very sizable market opportunity, and we're in there right now with a very competitive product. And we think we're step-changing now into something which is probably going to have specification leadership, and that opens up a new market opportunity for us. I would not want to put out any numbers in terms of our expectations other than to say we're seeing very good uptake. First publications are coming out. They are applauding our products in terms of their capabilities, and it is quite a sizable market opportunity for us.

Operator

Operator

And our last question for today comes from the line of Jon Goldberg of Macquarie.

Unknown Analyst

Analyst

This is actually Harris [ph] on for Jon. So I think going to this year, your plan was to offset the expected losses in HPV from contract loss with growth in NGS. And it seems like the HPV losses are happening a little bit quicker than expected while, at the same time, you've delayed the NGS launch. So where are you seeing better performance than you had anticipated at the start of the year?

Peer M. Schatz

Analyst

Sure. So what we always said is that, if you look at the prevention portfolio, it currently has 2 elements in it: one is tuberculosis. That is going to surpass $100 million in sales; and U.S. HPV, which is around that number as well. So we're probably going to -- in tuberculosis, we see over 20% growth. And then in HPV, we saw pricing related decline. We're actually quite successfully in maintaining market shares in this market. And so there's 2 products, basically, as we expect flooring of pricing situation in the United States to levels where even market share shifts would not really be too meaningful in terms of their overall impact on us as a company. TB and HPV are the 2 products that are offsetting each other currently. It has nothing to do with NGS. NGS has never been part of our financial plan going forward. We always made it very clear that we're asking that no numbers be included in this and -- as this is still a product in development.

John Gilardi

Analyst

I would like to close the conference call here and thank everyone for their participation. If you have any questions or comments, please contact [indiscernible]. Thank you very much.

Peer M. Schatz

Analyst

Thank you.

Operator

Operator

Ladies and gentlemen, this concludes the Qiagen's conference call. Thank you for joining, and have a pleasant day. Goodbye.