John Gilardi - VP, Corporate Communications and IR Peer Schatz - Chief Executive Officer Roland Sackers - Chief Financial Officer.
Vijay Kumar - Evercore ISI Brian Weinstein - William Blair Jack Meehan - Barclays Daniel Wendorff - Commerzbank Dan Leonard - Leerink Doug Schenkel - Cowen & Company Jeff Elliott - Robert W. Baird Zarak Khurshid - Wedbush Securities Isaac Ro - Goldman Sachs Dan Arias - Citigroup Derik De Bruin - Merrill Lynch Bill Quirk - Piper Jaffray.
Thank you, Patrick. And thank you for all of you for joining us today for our conference call. We are going to review the financial results we released last night and provide a business update before the Q&A session. Our speakers today are Peer Schatz, the Chief Executive Officer of QIAGEN, and Roland Sackers, the Chief Financial Officer.
On slide two, you will see the customary Safe Harbor Statement explaining that the discussion and responses to your questions on this call today reflect management’s view as of today, July 30, 2015. We will be making statements and providing responses to your questions that state our intentions, beliefs, expectations or predictions of the future.
And these are forward-looking statements for the purpose of the safe harbor provisions. These statements involve risks and uncertainties that could cause actual results to differ materially from those projected. QIAGEN disclaims any intention or obligation to revise any forward-looking statements.
For more information, please refer to our filings with the U.S. Securities and Exchange Commission. Also during this call, we will be referring to certain financial measures not prepared in accordance with Generally Accepted Accounting Principles or GAAP.
You can find a reconciliation of these figures to GAAP measures in the press release and the presentation for this call. I would like to now hand over to Peer..
Thank you, John. And welcome to all of you. We are moving ahead during 2015 in line with our goals and have these messages to summarize our performance for the second quarter and first half of this year.
First, we came in ahead of our targets for the second quarter, in particular adjusted net sales were up 5% at constant exchange rates and ahead of our 4% target, while adjusted EPS was $0.28 also at constant exchange rates and also ahead of the target with $0.26 to $0.27 per share.
We maintained the adjusted operating income margin at 25% of sales while making important investments to accelerate innovation and growth at the same time.
Adjusted net sales were $319.5 million of actual rates and declined 4% due to the anticipated currency headwind of 9 percentage points while adjusted EPS was $0.26 which was an increase from $0.25 a year ago. Second, we are moving ahead on transforming QIAGEN.
As you know our performance over the last two years has been marked by the sharp impact of the decline in revenues of HPV test in the United States that are used for cervical cancer screening against the ongoing solid growth from the rest of the QIAGEN portfolio. We saw the same trend in the second quarter. Sharply lower U.S.
sales of HPV tests created 3 percentage points of headwind which was in line with our expectations while the rest of the QIAGEN portfolio grew 8% at constant exchange rates and provided 97% of sales and led to the 5% constant exchange rate overall sales growth. Our customer classes delivered sales gains.
Molecular diagnostics benefitted from increasing contributions from the growth drivers.
Applied testing generated 11% constant exchange rate growth driven by human identification and forensics while Academia and pharma both grew 7% constant exchange rate on a mix of underlying growth and contributions from the acquisition in late 2014 of the Enzymatics Next-Gen Sequencing consumables portfolio.
All regions also delivered gains in the second quarter with the top seven emerging markets standing out with an 11% constant exchange rate growth and 15% of sales despite continued pressures in particular from Russia.
Our story is about the transformation of QIAGEN through targeted investments into its premium differentiated portfolio of products and solutions that are designed to address the needs of customers and life sciences and molecular diagnostics. Our solutions allow these customers to gain valuable molecular insights from any sample.
Third, we are re-affirming our full year guidance for higher adjusted net sales and earnings per share at constant exchange rates. We have also set goals for 2015 to increase free cash flow which was up 10% in the first half of the year to $84 million and deliver improvements in the adjusted operating income margin.
I also wanted to mention the senior leadership change announced with the quarterly release. Brad Crutchfield joined QIAGEN in June as Senior Vice President Head of the Life Sciences business area and a member of the executive committee. He has a great profile to lead our Life Sciences franchise.
Brad was most recently Vice President and General Manager for Europe, the Middle East and Africa at Illumina and prior to that he was at Bio-Rad and served at Executive Vice President and President of their Life Sciences Group.
We’ve made some significant changes to our leadership team over the last 12 to 18 months bringing in a mix of new leaders from outside as well as promoting from within. This team is well suited to address the opportunities we are facing. Moving to slide five. This slides you how QIAGEN has been growing during this challenging transformation.
As you know on the one side, we’ve been facing heavy price pressure in the United States for HPV test. And this was due to the entry of new competitors but we have maintained clear leadership albeit at a competition induced dramatically lower price.
For 2015, we continue to expect about 3 to 4 percentage points of headwind and this is in line with the first half. For the third quarter we expect three percentage points and about 1 to 2 percentage points in the fourth quarter.
This means the sales contribution from products related to HPV screening in the United States for the fourth quarter of 2015 will be well below 3% of our total sales so any future change in the U.S. HPV franchise is not expected to have a major impact on overall QIAGEN sales.
So we are nearing the end of this headwind, during late 2015, and then you will see a faster overall growth rate for QIAGEN that is being driven by the solid performance from the rest of our business. I’m now on slide six to discuss the growth drivers.
On the QIAsymphony Automation Platform new test submissions are expected later this year and we have a new collaboration we disclosed as well with Seegene.
This partnership involves developing panels using the Seegene assay design approach to create assays for infectious disease, panels with a goal to enable simultaneous amplification of upto 20 targets per two. The test will be validated on QIAsymphony RGQ and we will market the assays.
Another highlight brings together the automation power of QIAsymphony and our leadership in liquid biopsy sample technologies. These involve taking a body fluid most often blood to gain access to DNA and or RNA. Our presence in this field is very strong as a supplier to almost every participant conducting or evaluating liquid biopsy testing.
Our teams have launched a breakthrough protocol to automate the isolation of free circulating DNA from human plasma in a highly automated format which can address their high throughput needs of example given NIPT team as well as the stringent requirements there as well as in the emerging area of cancer testing.
Customer feedback has been very positive. On QuantiFERON I want to mention the new Director from OSHA, the U.S. Occupational Safety & Health Administration for TB screening of healthcare workers.
This is the first such update on this topic in a long time and it included for the first time a reference to the modern TB test and the only one mentioned was QuantiFERON TB goal as an alternative to the traditional skin test.
This is through the validation of our leading position in customer value proposition which is based on offering the most cost effective and clinically validated TB test.
We also advanced our personalized healthcare portfolio in particular with the FDA approval of therascreen EGFR kit as a companion diagnostic to guide the use of AstraZeneca's targeted lung cancer therapy IRESSA. This marks the fourth U.S.
Regulatory Approval of a QIAGEN companion diagnostic paired with a targeted cancer therapy and this further validates our leadership position in this exciting area. The inflow of new projects in partnership with pharmaceutical companies has never been stronger and spans across all platforms, PCR, NGS and Modaflex.
In next-gen sequencing preparations are progressing as planned for its commercialization of the GeneReader benchtop NGS workflow in the second half of 2015 and we are looking forward to have more to share with you later this year. And now on slide seven and would like to share an update on our bioinformatics franchise.
On this slide, you see that our offering goes far beyond creating a seamless workflow to transform complex biological data coming out of sequencers into valuable molecular insights.
What we are offering is even more and what our customer’s value is a meta knowledge base that ties to get our own solutions with other proprietary and public resources and data sets to enable a much more powerful interpretation.
Our solutions have to come to standard to interpret findings by leveraging a wide range of knowledge bases and data sets, sometimes even including a customer’s own data sets and findings.
So this is why you see us offering a range of solutions for analyzing and interpreting biological data in various ways and behind which we are investing as well as attracting new partners.
A great example is that QIAGEN and Inova Translational Medicine Institute had launched Inova Genomes, a unique compendium of a very large cohort of whole-genome sequencing data; which is highly annotated and described as well as ethnically and typically and test fully diverse.
The Inova partnership adds a great additional tool that further increases the value of our offering for researchers seeking to accelerate cohort analysis programs or improve success rates and diagnostic odyssey cases.
QIAGEN serves as the exclusive distributor of the data base which is accessible by Ingenuity Variant Analysis and CLC Biomedical Genomics Workbench platforms. [Indiscernible] In precision medicine your ability to make impactful decisions and discoveries from each new data set rests heavily on analyzing the data in the richest context possible.
How much information you have about other genomes and health outcomes associated with those genomes and what’s known from peer [ph] review published research.
So an ethnically diverse genome database like the Inova genome database when paired with big data competition and expertly created content resources such as the ingenuity knowledge base can dramatically advance disease, research and drive the adoption of next generation sequencing in the clinical setting.
As for our new commercial solutions the global rollout of QIAGEN clinically inside or QCI is building great momentum. This evidence based clinical decision to port solution design for clinical labs to use in the interpretation and reporting of complex genomic variance from NGS data. The first applications involve hereditary and somatic cancer panels.
QCI or QIAGEN Clinical Insights and other solutions on this chart draw insights from QIAGEN and Genuity Knowledge base which you see here as the key content foundation and which has so far been used to analyze nearly 400,000 human genomic samples.
Another new solution recently launched is the CLC Microbial Genomics Module within CLC software portfolio. This module enables academic and commercial researchers to focus on food production, agricultural biology and infectious diseases to visually explore and analyze microbions. As a standard setter, our approach is to be platform agnostic.
At the same time, we will show that a perfect alignment with the platforms and assays on the GeneReader system will allow for a very unique sample to insight experience. I’m now on slide eight to discuss our recent entry into the high value segment of the U.S. forensics market. The U.S.
is the largest market for forensics with around credited laboratories analyzing more than 4 million case working reference samples per year. In the U.S. we have been offering sample technologies and this is part of our very high market share and sample technologies for forensics around the world.
We are in practically every laboratory worldwide conducting forensic testing with such sample technologies. Now, with the expiry of some patents in the United States we are entering the assay market segment with our investigator [Indiscernible] for genetic finger printing.
Once those patents expired in June, QIAGEN became the first new entrant into a market which previously was a duopoly, the area of STR assays or short tandem repeats that is essential for DNA forensic testing as well as other types of genetic finger printing. The timing could not be better since U.S.
labs are conditioning to comply with new FBI Standards in 2017. The new investigator STR kits fully comply with these requirements which include 24 markers compared to 13 before. In addition our new line of assays have many workflow benefits and a range of novel features.
The most important new feature of our offering is a new quality sensor that evaluates the quality of DNA in each sample prior to going into time consuming and costly testing.
This novel QIAGEN technology enables labs to therefore decide quickly which evidence may provide valuable results and overcome key concerns such as determining truly negative results assessing DNA degradation and also accessing inhibitors in the PCR process. QIAGEN is the global leader in sample technologies and human identification and forensics.
With this franchise representing the majority of our applied testing customer class which contributed about 9% of overall sales to QIAGEN and also involves solution for veterinary medicine and food testing. We are already successfully commercialized in this new QIAGEN investigator STR kits in other regions of the world.
So moving into this new segment in the United States offer some attractive incremental growth opportunities and be a chance to maximize the value of offering a full portfolio like elsewhere in the world. With that, I would like to hand over to Roland.
Thank you, Peer. Good afternoon to everyone in Europe, and good morning to those joining from the U.S. I’m now on slide nine and will begin with an overview of our financial performance for the second quarter.
Starting with adjusted net sales, we delivered 5% towards growth at constant exchange rates which was higher than our target of 4% and driven by the outstanding 18% constant exchange rate growth in instrument sales. Consumers and related revenues were up 4% constant exchange rates in the quarter and represented 87% of sales.
The acquisition of Enzymatics provided 2 percentage points while the rest of the portfolio generated 3 points of growth and that was after absorbing 3 percentage points lost to lower U.S HPV sales.
The adverse currency movements created 9 percentage points of pressure on sales at actual rates which was in line with our expectations and led to the 4% decline through [Indiscernible] $19.5 million U.S. dollars.
Moving down to income statement, the adjusted operating income margin had 20 basis points of improvement with about half coming from operational gains and the rest coming from currency benefits.
On the adjusted gross margin we had a relatively high level of revenues from pharma co-developed project in the quarter and this was a key factor behind the decline of about 90 basis points.
These revenues have a gross margin of about 30% to 50% which is below the company average; however keep in mind these revenues have a relatively high margin at adjusted operating income. Another factor versus strong growth in instruments which have a lower gross margins and consumers.
As we previously announced the teams and activities at our site in Marseille, France were spun off earlier this year through the creation a new standalone company.
These activities were focussed on the Ipsogen franchise where we have a strong leadership position just for the good solution for this side the employees and shareholders and we have future rights to sell their products and this transaction played a role in the overall lower level of RD investments for the second quarter.
Sales and marketing expenses were generally flat compared to the same period in 2014 as we made investments in e-commerce and commercial activities by generating benefits from the efficiency program done last year.
For the full year, we have a goal to improve the just operating income margin by at least 50 basis points and this is from the 25% underlying margin last year. The full year margin in 2014 was 23% but this included a restructuring charges taken in the fourth quarter. Keep in mind that this target is based on actual FX rates.
Adjusted net income was $60.9 million and this was unchanged from the year ago period. So adjusted tax rate was lower in the second quarter at 19% but in line with our outlook and this helped to more than offset an increase in total other expenses.
Adjusted EPS was $0.28 per share at constant exchange rate which was above the target for $0.26 to $0.27. At – adjusted EPS was $0.26 per share which was ahead of $0.25 per share a year ago.
The diluted share count for the second quarter was about 3.6 million shares below the same period of 2014 and this was due to the convertible bond we purchased earlier this year and shares we purchased over the last 12 months. Moving to slide 10, I would like to provide you with a quick overview of the customer classes.
As noted earlier, these include contributions from the Enzymatics acquisitions in December 2014. Molecular diagnostics excluding U.S. HPV sales continued at a solid underlying 10% growth pace at constant exchange rate.
We delivered double digit constant exchange rate sales expansion for the QuantiFERON latent and TB test and higher sales in personalized healthcare came from company diagnostic kits and significantly higher pharma co-developed project revenues.
We also continued the strong pace of instruments and consumables sales growth momentum for the QIAsymphony system in the quarter as well. In the life science, applied testing led to the performance on the back of increasing demand in human ID and forensics.
Trends improved in pharma as underlying business expansion at a mid single-digit constant exchange rate, and first time contributions from the Enzymatics acquisitions led to 7% constant exchange rate both in the quarter and for 5% constant exchange rate growth for the first half year.
Academia delivered the same growth figures as pharma on the same mix of underlying growth at a moderate single digit constant exchange rate and contributions from Enzymatics. Here we are seeing more positive customer spending patterns in the U.S. and key European markets than the first half of 2015 and remain cautiously optimistic.
I’m now on slide 11 to review sales on a regional basis for the second quarter. The top seven emerging markets delivered 11% growth at constant exchange rate in the second quarter and were up 16% for the first half.
China remains a bright spot rising at the highest single digit constant exchange rate and we also had solid performance in Turkey and Korea. On the other hand, Russia remains a challenge but has now become a small share of sales.
Asia-Pacific Japan generated 14% constant exchange rate growth for the quarter and was up 10% constant exchange rate for the first half. In addition to China, Korea Japan or it’s a generated gains but like other companies we are cautious on the current funding trend.
In the Europe, Middle East, Africa region sales were up 3% constant exchange rate for the quarter and up 6% constant exchange rate for the first half of the year led by the performance in Germany, Turkey and the United Kingdom. The Americas grew 11% excluding U.S. HPV sales and this came from QuantiFERON-TB test sales in the U.S.
as well as gains in Applied Testing, Academia and Pharma. On slide 12 you have a view of our performance for the first half of the year. This was in line with our 2015 targets with a sales growth of 4% constant exchange rate matching our full year outlook.
Adjusted EPS was up $0.05 per share at constant exchange rate for the first half of the year and this was in line with our planning and the same goes for the steady adjusted operating income margin at 24% of sales.
So based on this performance and also our expectations for the second half of the year this prompted us to reaffirm the full year outlook we provided earlier this year and January. Moving to slide 13 we have a healthy financial position with manageable net debt to support business investments and returns to shareholders.
Even with currency volatility, we still increased operating cash flow in the first half of the year. Free cash flow also rose for the first half of 2015 while absorbing higher investments in property, plant and equipment and this were mainly for internally developed software and expanding our U.S. presence especially in the Boston area.
Our leverage has now increased to about 1.6 times net debt to EBITDA and this includes $250 million to repurchase the 20, 24 convertible notes earlier this year and remove 10 million shares of dilution risk.
On the share repurchase we have about $30 million to grow in the $1200 [ph] million programs and our view is that this programs have been good way to increase swith-ons. The weighted average repurchase price is a short program so has been €19.22 and for all programs to date it is s €16.50 and this is below the current share price of about €25.
I’m now on slide 14 which shows we are re-affirming the same full year guidance for 2015 that we announced in earlier this year in January. We continue to expect full year sales growth of about 4% at constant exchange rate.
This is based on about 7 to 8 percentage points of constant exchange rate brought from our core portfolio against the [Indiscernible] of significant headwinds from the U.S. HPV test deals. And we continue to expect this to be about 3 to 4 percentage points.
For adjusted EPS we continue to expect about $1.16 to $1.18 per share and this is at constant exchange rates. These expectations also include incremental sales on the Enzymatic acquisition that was completed in December of 2014. Moving to slide 15, here you see our outlook for the third quarter and details on the adjustments.
For the third quarter our sales target is for 3% constant exchange rate growth and this is based on 3% points of headwinds from the U.S. HPV franchise against 6% constant exchange rate growth from the rest of the QIAGEN portfolio.
This reflects our view to deliver on our full year target for 4% constant exchange rate growth and the anticipated distribution of sales between the third and fourth quarter.
We are seeing more volatility in the timing of some of the larger blocks of sales in our portfolio such as from pharma development project or national tenders and this outlook is based on how we anticipate those revenues to be realised.
We are also facing a tough comparison against the strong performance in the third quarter of 2014 when we had 10% constant exchange rate growth from the portfolio excluding U.S. HPV test fall out. And this is something we had factored into the guidance we gave at the beginning of the year and that we have reiterated.
As for adjusted EPS for the third quarter our outlook is for $0.29 to $0.30 per share which is also at constant exchange rates. As for our views on currency movements the headwinds created by the strengthening U.S. dollars begin at the end of 2014 and they got worse during the first quarter at about 8 percentage points.
We then saw even more volatility in the second quarter and about 9 percentage points of pressure on sales results at actual exchange rate. For the third quarter and based on rates as of June 30, we expect about 7 to 8 percentage points of currency pressure on sales.
So given the outlook for 3% constant exchange rate sales growth this implies a – of about 4% to 5% at actual exchange rate. On adjusted EPS the currency impact is expected to be $0.02 so this implies $0.27 to $0.28 per share at actual rate. This slide also contains adjustments, exemptions for the full year and the third quarter.
So tax rate remains unchanged at about 19%. With that I would like to hand back to Peer..
Yes, thank you, Roland. I am now on slide 16 for a quick summary before we move into Q&A. Let me review what we have announced. First, we delivered another solid performance in the second quarter of 2015, having exceeded our targets for adjusted net sales and EPS at constant exchange.
We are pleased as well with the results for the first half of the year that put us on track to achieve our full year goals. Second, we are moving ahead on initiatives to transform QIAGEN and are demonstrating continued success in areas that are delivering strong growth in our very exciting futures.
We have some important regulatory approvals and new product launches in the quarter particularly with EGFR companion diagnostic paired with IRESSA for lung cancer patients and a protocol to automate liquid biopsy sample platform QIAsymphony.
All of this is in line with our ambitions to offer premium differentiator product and services to our customers in the life sciences and molecular diagnostics.
The benefits of these efforts will become even more apparent during the second half of 2015 as we work through the final two quarters of significant headwinds from the declining sales in the U.S. HPV test franchise. Indeed this year is setting a good foundation for accelerating, innovation and growth from our core portfolio.
And as Roland just outlined, we are reaffirming our full year guidance for higher adjusted net sales and EPS at constant exchange rates along with ambitions to improve our operational profitability and increase cash flow but again for results at exchange rates to be adversely impacted by currencies.
With that I would like to hand back to the operator for the Q&A session. Thank you..
[Operator Instructions]. And our first question today comes from the line of Vijay Kumar of Evercore ISI. Please go ahead..
Hey thanks guys. Well So, Peer, a question on the growth driver. So I feel like there were a number of exciting sort of announcements within the press release. And I think couple which caught my attention was one on liquid biopsy. I think the term you used was breakthrough.
So I'm just trying to understand sort of how big is this market opportunity for you guys and how does QIAGEN fit in? How do you think the growth from this particular end market could be for you guys and related to sort of liquid biopsy, I guess, was GeneRreeder and you said more to share later in the year? So would this be sort of some sort of specs on the system or maybe further updates on the commercialization or some sort of customer feedback I'm curious?.
Hey, yes thanks for the question. So liquid biopsy is an important area of strategic initiative for us. We have significant efforts in this area and we are working on two [audio gap] that of the second generation.
We had an earlier version before that we were able to substantially increase the speed of and also increase the flexibility also with the QIAGEN’s new platform we have now a platform that is slowly targeting clinical use and has the ability to flexibly process hefty samples, liquid biopsy samples all in parallel for downstream processing and this is important and at the speed that is sufficient even for a high throughput in ITT labs and had a precision that meets those requirements as well as those for instance in cancer.
The market is substantial. It is still small and I see this huge numbers they depict [ph] out there in terms of the estimates of the market size. They typically include the full package of including also the services, so from a few hundred to a few thousand dollars per assay.
The sample technology piece ranges somewhere in the range of $15 to $30 per assay. So you can just extrapolate the numbers, assume a high market share and that will be the goal for our franchise in that access. The second access is the one where we are pairing up the liquid biopsy strength with assays that we have.
We were the first to introduce a regulated liquid biopsy assay also with IRESSA earlier this year for the companion diagnostic and we are also ensuring that all of our downstream assays and panels are already liquid biopsy compatible and hence also the reference that you just made, the GeneReader.
Yes, the GeneRead panels that we have in the market today they are already liquid biopsy ready while other suppliers in to this market typically require some sort of front end modification to the assays to make them compactible.
So the same assay that can run off FFPE samples can also be run after liquid biopsy samples and we think that’s incredibly important to ensure good work flow opportunities and also efficiencies in clinical laboratories..
Our next question comes from the line of Brian Weinstein of William Blair. Please go ahead..
Hi, thanks for taking the question. I wanted to talk a little bit about personalized healthcare; you had a very strong quarter. I'm wondering if you could kind of give us the size of that business now and talk through the components between the FDA approved tests and the partnerships in terms of that size.
And also when thinking about working with these pharma partners, what technology platforms are of interest to them at this point PCR, next-gen sequencing, ModaPlex can you just sort of flesh that out a bit for us? Thanks..
Great, thanks Brian. The franchise is definitely doing extremely well, and it's obviously well north of 100 million including all the components of which the majority are kit sales. The numbers for the partnership contracts is a third or less of that numbers so the majority is actually recurring revenue streams.
And the number of partnerships and also the breadth of the menu had been at record level this year. We have never seen such strong inflow of new partnerships and deals as we’ve seen in the first half of 2015 and obviously this is great for the future menu development and expansion of the portfolio.
The platforms that expands – still a lot of the drugs are preferring PCR due to the very clear path forward. In terms of the regulatory path, in term of reimbursement and this is true in almost all geographies across the world.
That said, we are also starting to see first next-gen sequencing programs and we are working on several already today, and very often in parallel to PCR assays to make sure that we can also address the global differences and reimbursement and regulatory.
So many countries will be extremely difficult to – or it will take quite some time until they will be ready for next-gen sequencing so their PCR assets would be preferred in testing both in parallel as a big benefit. So that’s number two. And what we’ve actually seen a remarkable interest in is in ModaPlex.
ModaPlex which is a platform we are not commercialising actively at the moment, but we are prepping here for companion diagnostic usage is receiving also here a record inflow of new partnerships that are using this multi modality capability of that platform.
And also see great value that platform is already FDA-cleared and also has a very clear path to reimbursement.
So we are not platform agnostic, we are not trying to force a platform onto the pharma partners but are trying to do what is best for their update of the drug and that has been resonating very well with pharma and the inflow it’s just remarkable that we’ve seen this year..
Our next question comes from the line of Jack Meehan of Barclays. Please go ahead..
Hi, thanks and good morning and good afternoon. I just want to start and ask about QuantiFERON and the growth in the quarter. I'm curious with some of the publications at the start the year whether you thought you had seen any changes in the market share.
And then also just to how far along you thought you were in converting from the 3G product to the new fourth generation out on the market?.
Sure, thanks. So the 4G has been on the market since earlier this year and we’ve seen good uptake. As always it take some time for this transition to happen as laboratories have their existing validation routines and procedures. And the uptake is moving ahead quite nicely now in Europe.
The lag that you typically see is at least a few months, six months or so, we’re kind of like now moving through that.
The 4G product has a number of features that are easy to see the immediate benefit for, the workflow benefits for instance, the one, two collection and all these things that the quality comparability with the leading quality of 3G product.
But some of the benefits such as the ability to differentiate between active and latent are features that we’re still currently working on and you’ve seen some announcements both in developed world but also in developing world where we’re actually validating this already.
So this is going to be a multiyear validation process, but we’re well underway on that as well. So 4G is going to move into the U.S. markets as well once we get the PMA on that and the timing is hopefully not far away.
And this would allow us to start the active conversions in the states where we do see some benefits in particular off from the workflow side..
Our next question comes from the line of Daniel Wendorff of Commerzbank. Please go ahead..
Hi, thanks for taking my questions.
I'd like to go back to slide eight actually just to better understand the market opportunities there and would you be the only company entering the assay technologies markets and following the expiry of certain patents as you just mentioned, and I assume that you just have another product for an existing customer marketing infrastructures, is that correct?.
The latter is definitely correct, and we are in all of these laboratories are into today, it’s a market we really like serving. It’s a technologically very challenging and one that we’ve been for at least 25 years now.
And the second part of the question is, there are IP position, new IP positions now have to the access and also license, and so we think that if you look at the all these players in the market I couldn’t imagine anybody here now the near term to the market which would have meaningful impact.
This is a market that is definitely going to be PCR for quite a long time and extremely conservative market and were the costs and other benefits of this technology are just well ahead of anything else, and so we see that this is probably going to remain pretty stable for the next few years with the exception of the few smaller segments of the market where you might see diversification..
Our next question comes from the line of Dan Leonard of Leerink. Please go ahead..
Thank you. So, two-part question on the bioinformatics business. One, disclose the growth rate of the bioinformatics business in the quarter? And then secondly, could you elaborate on the launch of Clinical Insight? You mentioned it was a positive launch above expectations, but can you convey what the bogey was and what you delivered? Thank you..
Sure. So, I’ll talk very briefly about the launch and Rolland you can take the financial question. The launch went extremely well and it has surpassed our expectations.
Clinical Insights is hitting a very important need in the market as clinical use of high bandwidth technologies have been increasing particular in next-gen sequencing and this has led to enormous backlog very often and work our efforts that very often mean library visits and just working through all of the variants that available in the institution.
And we’re basically using the cloud solutions that we’ve created.
Actually, somebody recently told me that we were actually the first life science company in the cloud early almost 15 years ago which was the first in Ingenuity product and we’re basically leveraging that now for clinical use ensuring up to-date information which is valuable for clinical labs so they don’t make wrong calls.
So this uptake is going extremely.
We’re obviously leveraging a lot of contacts that we have across the clinical industry and are using shared sales channels with the specialists and also the generalist strategic account [ph] managers, so this is early in the uptake phase, but we’re very pleased with the uptake and many high profile names have joined the customer roaster.
Rolland?.
Hi, Dan.
Bioinformatics is doing well on a year to-date to ends this quarter at double-digit pace and I think its probably more important we’re fully more important, it clearly also comes to the very healthy gross margin [Indiscernible] you know we invest significantly into R&Ds, so there’s no significant EBIT contribution this year, but clearly it setup the change as going forward.
So we’re quite pleased with the business..
Our next question comes from the line Doug Schenkel of Cowen & Company. Please go ahead..
Hi, everybody. Thank you for taking the question. Peer, the QIAGEN portfolio has evolved quite a bit over the past few years, and if you look back over the past few quarters, including this one. If you exclude U.S. HPV FX and M&A consumables then related revenue growth has been around 5% with some error bars around that.
And within that 5% there have been areas that have been and appear poised to grow much more quickly and we've talked a lot about these, but they include some of the nice assets you've picked up in bioinformatics, latent TB, the efforts in liquid biopsy and as we talked about earlier today, the outlook for growth in certain new applied areas.
That said, there is also some core areas other than U.S. HPV that continue to be lower growth.
So when you think about the puts and takes, given all the strategic activity and internal development that you've undertaken, would you view 5% to 6% normalized consumables growth as a disappointment as we look ahead to 2016 and beyond? And I guess as a follow-up, if you believe that QIAGEN is now built to grow it and inherently higher growth rate than that, have the investments you've already made position you to generate a pickup in operating margin leverage over the next few years? Thank you..
Thanks, Doug. So the growth rate that achieved in the second quarter was slightly higher than what we had guided for, so we are definitely pleased with the momentum across the portfolio.
You’re absolutely right we clearly have big exposures in areas that is academic research which is not really growing with the exception of next-gen sequencing and are 67 million exposure in this space are growing at a higher growth rate is not enough to push the several hundred million that we have exposed to the lower growth academic segments.
That said the percentage of revenues that are growing at high double-digit growth rates are now north of a third of the company and growing substantially.
So, our goal is to not only maintained but to try to accelerate this growth rate over the next period and we’ll give guidance for 2016 and as we always do in January and we clearly have stated however that we are striving to a increase the underlying growth rate due to the heavier exposure to higher growth segments within our portfolio.
And that’s why we’re emphasizing them so much because we believe that all of them have very long trajectories that we’ll be able to benefit from..
And Doug on your margin question, I think the best way to answer is also look just on what we have seen in the second quarter and also what we guided now for the third quarter and the rest of the year and having mindset within this quarter. We still have a quite significant headwind on the U.S.
HPV side which clearly comes still as a very healthy gross margin. Despite this fact we are still able to improve our operating margin as we have seen this quarter by roughly 50 bps, so it’s now going away and fading out over the course of the next few quarters.
I think we feel quite concerned [ph] in terms of overall operating margin improvement as we announced before..
Our next question comes from the line Jeff Elliott of Robert W. Baird. Please go ahead..
Thanks guys. A couple of quick ones for Roland here. Roland, can you talk about free cash flow, what's your outlook for the next couple of years? And then on the leverage, it has worked its way up a bit.
What sort of metrics -- where would you expect to be or where would you be comfortable seeing that you are now under leveraged?.
Yes. Thanks for the question, Jeff. On the free cash flow we clearly are doing quite comfortable with the developments we’ve now seen over the first six quarters. We do expect also similar developments going forward.
The cash conversion remains about 100% and I think there is clearly an area where we also working on, focusing on and have still in mind that we did a lot of restructuring in 2014, happy that we went out of that and we’re still in the earning mode on that, so again there’s more to come.
On the net debt to EBITDA side, I would say, right now we still feel clearly still under leveraged. We are very much committed to capital allocation as we said before.
We are now still have some openness in our$800 [ph] million share buyback program, that’s clearly one thing and more important is probably also in terms of cash flow and then fire power at the same time nearly up to three [ph] is still reasonable for company with cash contribution, with the cash generation we are having, so I think there’s a lot of room for us to be flexible on the strategy side as well on the capital allocation side in general..
Next question comes from the line of Zarak Khurshid of Wedbush Securities. Please go head..
Hi there everybody. Thanks for taking the questions. As we think about your total liquid biopsy related businesses versus your NIPT exposure.
Any sense that you can quantify for us kind of in an absolute sense how large these buckets are and/or how fast they are growing? And then as a follow-up, just curious how -- as those end markets continue to grow very fast, how does your business scale with that? Does it grow at kind of a slightly reduced rate to the end market or do you kind of keep pace? Thanks a lot..
Sure. So, as you know there are few million liquid biopsy test performed every year, the majority are NIPT, its maybe a quarter or cancer today and lot of them exploratory maybe a third.
But the cancer piece is growing quite substantially and its very, very different to the NIPT market, the NIPT market is under intense competition and also in price and cost pressure and the cancer market is one which is more exploratory and one which is emerging quite quickly and clearly as a different reimbursement setting as well.
So the market going forward will see volume increase significantly, we’ll see the volume growth driven through a much larger degree by cancer going forward and the prices are very stable in caner, very attractive in cancer for the foreseeable future and NIPT will be a more competitive, cost competitive market.
This franchise is a few tens of million now for us but it is one that is – its clearly one that we’re investing in and as you see from the numbers very, very strong leadership positions and we’re fueling that with great new products that we have both organically and also inorganically added to the portfolio..
Our next question comes from the line Isaac Ro of Goldman Sachs. Please go ahead..
Hi, good morning. Thank you, guys. Question for you on sample prep technology, you guys gave a lot of color on the various end markets that you serve and you've obviously got a lot going on in next-gen sequencing.
And I was curious, if you could maybe take a different cut at the numbers and specifically wondering with all the growth that we're seeing in next-gen sequencing, obviously your assembled prep gets used quite a bit.
Can you give us a sense of how much year-to-date your sample prep business tied to NGS has grown and sort of how you're thinking about that opportunity because you're clearly still in a very strong position of benefit from that volume growth?.
Sure. Thanks, Isaac. So, we once put out a number that we think that about 85% of all samples that are process for next-gen sequencing, our process typically using QIAGEN sample technology upfront.
Where the confusion kicks in is that people talked about sample preparation for next-gen sequencing which includes the library preparation steps, which is a multi-hundred million dollar business.
When we talk about sample technologies, that means the processing of a drop of blood or a piece of tissue into purified isolated nucleic acid and in that area, what we call sample technologies, our market shares are very, very high, so it can almost – and the challenges for next-gen sequencing are very significant in terms of requiring good pure nucleic acid, because very often the input volumes are very small so you won’t have a very clean and good sample going into these very cost intensive and expensive downstream assays.
That said, next-gen sequencing is only a very, very small fraction of all sample processing being done in research diagnostic even though the market is multi-billion dollar market and the cost of the assay is very often logs higher than what you would typical have with PCR or other molecular assays and hence the volumes are still immensely higher in the non-NGS areas compared to the NGS areas.
So volume growth in this area is meaningful for us is dollar amount but as an overall revenue contributor its one that will all the time but currently is still not the major within the academic as well as clinical segments of our business..
Next question comes from the line of Dan Arias of Citigroup. Please go ahead..
Good morning. Thanks for the question, guys. On QIAsymphony rolling, I think you guys said that consumables' pull-through on the system was up 25% or so last year, just wondering whether as boxes this year track in line with that 250 or so you placed last year, are you thinking the 2015 pull through will track in line at 25% as well.
And then can you just remind us what to look for in terms of new tests and timing for new products in the back half? Thanks..
Yes. Let me take the first part of the question.
Yes, I think we see actually similar trends in 2015 as well as, so we are quite happy with QIAsymphony performance in general, I know from the outside there’s always a lot of focus on placement, but as you pointed out correctly it's even as important and probably more important for us to pull through on the instruments and there is clearly a number which is still going to be significantly double-digit and I don’t see any reason that its going to change, and menu expansion, Peer..
Menu expansion is ongoing with the focus currently on Europe, so we have several new assays come onto the platform in Europe that are doing quite well, as you see us from replacements in that region. So we’re well on track to make the 250 target for this year.
And that said, we are very selective in the menu that we’re putting on to the system because we’re seeing great traction in particular also in the LBT field and so having select markers to augment that differentiation is in a good value proposition for a customers in the U.S..
Our next question comes from the line of Derik De Bruin of Merrill Lynch. Please go ahead..
Hi, good morning. Hey, I have one quick clean up question for Roland and then another one, the cleanup question is the FX impacts to EPS in Q3 and Q4 and then the bigger question is we've seen some companies in the next-gen sequencing space have to reduce guidance because they're not getting reimbursement.
I guess can you talk a little bit about how you sort of see the reimbursement for the panels sort of playing out? What sort of milestones are you looking for in terms of getting increased volumes and just talk about you're like the competitive dynamic in the panel space because there is a lot of vendors out there?.
Let me go off here [Indiscernible] Derik, so FX impact on EPS on adjusted side for the third quarter using June status where it is probably around $0.02 for the four quarter probably down to $0.01..
Yes. And to the first part, you’re absolutely right, and we’ve talked about this many times in the past. I think there’s a general enthusiasm around next-gen sequencing, but the realities are definitely starting to hit. And the realities are visible in the slow adoption and reimbursement.
But if you go deeper into why this is a case, you’ll see that the validation of markers is in many cases just not sufficient to justify these broad panels and there had to be a lot of additional validation work or justification of use of the markers that last one to get reimbursement for.
This is one of the reasons why the QIAGEN clinical insight is such an important tool because we are giving laboratories at the push of a button a comprehensive justification for the markers that are being tested for around certain disease areas.
And this is I think one thing that we’ve seen laboratories really about this is that it is helping them prepare the submission – the reimbursement of test they perform. And going forward the panels will definitely want to rely markers that are sufficiently validated and the question is will this be 50 markers or be 15.
This is still a little bit out there.
It probably won’t be 100 at now for a few years, because large number of these markers are just not validated yet sufficiently that would allow for clinical reimbursement and as the cost still quite high you see the number of markers and the costs correlate into a curve that put some out of I think reasonable at some point.
So we think these targeted panels likely for instance offer the Ingenuity panels and doing very well.
They are targeting very well validated markers and are in that one dozen to several dozen markers, hotspot panels might be over 100, but the focus on clinical validation is an action ability is going to become the focus going forward for laboratories and not just what can we read and how much can we read.
There are some interesting pieces coming out for many of you or you’re saying, its not about the box, its really about the utility that the box generates and there we certainly see a mismatch being at in cost, being at reimbursement, being the regulatory pathways and I think as an industry we need to be very prudent and how we push this forward to make sure that we also create some thing that the healthcare system is well be able to benefit from economically and clinically..
Our next question comes from the line of Bill Quirk of Piper Jaffray. Please go ahead..
Great. Thanks and good morning everyone. Two quick questions from me. First is on the clinical instrument strength.
Can you also think a little bit about the difference between let’s say the strength in QIAsymphony for running molecular assays versus some of like say, the NGS base strength and things like QIAcube and other instruments?.
So what is interesting Bill is that the QIAsymphony is getting great uptake in the NGS labs in particular also due to its ability to process some many different sample types in a highly automated way, especially for labs that are doing larger batches and for instance also NIPT labs. So QIAsymphony received a surprising good uptake in the first wave.
We also knew it would be in very attractive position, but as it was primarily perceived as a clinical instrument the adoption has been just very, very positive.
The QIAcube is we have double-digit thousand number of these same things out there, they are all over the place and they are like 200 protocols running or 250 protocols running on this thing, so most of the laboratories actually have a QIAsymphony maybe even a QIAcube for very exotic applications as well in addition to QIAsymphony in their laboratories.
So it is a clinical instrument at one side but they are also sticking to NGS samples on to it as well..
Okay. I’d like to close this conference call. And thank all of your for your participation. If you have any questions or comments, please don’t hesitate to send me an email or give me a call and get back to you about your questions. Thank you very much..