John Gilardi – Investor Relations Peer M. Schatz – Chief Executive Officer Roland Sackers – Chief Financial Officer.
Derik de Bruin – Bank of America Merrill Lynch Daniel Wendorff – Commerzbank AG Tycho W. Peterson – JPMorgan Chase & Co. Isaac Ro – Goldman Sachs Group, Inc Daniel Arias – Citigroup Zarak Khurshid – Wedbush Securities Vijay Kumar – ISI Group LLC Daniel L. Leonard – Leerink Swann LLC Jeffrey Elliott – Robert W. Baird & Co.
Gunnar Romer – Deutsche Bank Tim Evans – Wells Fargo Securities Paul Knight – Janney Capital Markets.
Ladies and gentlemen, thank you for standing by. I am Sachi, your Chorus Call operator. Welcome and thank you for joining QIAGEN’s Conference Call to discuss results for the Q3 of 2014. At this time, all participants are in a listen-only mode.
Please be advised that this call is being recorded at QIAGEN’s request and will be made available on their Internet site. The presentation will be followed by a question-and-answer session. (Operator Instructions) At this time, I would like to introduce your host, John Gilardi, Vice President of Corporate Communications at QIAGEN. Please go ahead..
Hello and welcome to our conference call tonight. Our speakers today are Peer Schatz, the CEO of QIAGEN; and Roland Sackers, our CFO. Before we begin, I’d like to thank all of you for participating today at this unusual time for QIAGEN results call. The reason for the change was our supervisory board meeting this week at our Silicon Valley site.
We will return to our traditional schedule with the fourth quarter results in January. On Slide 2, you’ll see the customary disclaimer. The discussions and responses to your questions on this call reflect management’s views as of today, October 29, 2014.
We will be making statements and providing responses to your questions that state our intentions, beliefs, expectations or predictions of the future. And these constitute 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. I would like to now hand over to Peer..
Thank you, John. Hello and welcome to our call today to discuss results for the third quarter and also for first nine months of the year. Our teams at QIAGEN are moving ahead to accelerate the pace of innovation and growth and we have three messages for you today. First, we achieved our target for the third quarter.
As you saw in the press release, adjusted net sales rose 4% at constant exchange rates in the third quarter and this was in line with our communicated target for about 4% to 5% growth. These results include the expected decline in sales of our U.S. HPV test portfolio, which created about 5 percentage points of headwind in the third quarter.
In other words, our growth excluding the HPV headwinds in the U.S. was 10% at constant exchange rates. In terms of earnings, the adjusted operating income margin remained at 25% while adjusted EPS was $0.27 per share and at the high-end of the guidance set for $0.26 to $0.27 per share. We also had strong free cash flow of $72 million in the quarter.
Second, we are moving ahead on initiatives to accelerate innovation and growth, especially among our growth drivers that are creating a foundation for sustainable and long-term expansion. These products together are growing at a solid double-digit pace, now providing about 30% of our total sales.
There were many recent achievements, but I’d like to quickly highlight the advances in Personalized Healthcare. First, you saw the news this week about our eighth master collaboration agreement and this was with Astellas Pharma of Japan. The Astellas collaboration involves a range of drug candidates in several therapeutic areas.
Furthermore, this is another partner gaining access to our development capabilities and full workflows for both tissue and liquid biopsy processing and involving PCR, NGS and multimodal testing technologies.
In terms of liquid biopsies, this is a very dynamic area and we are active in this field across numerous collaborations and have already standardized key areas of this emerging field with the automated solutions for liquid biopsy processing.
As discussed in our last call, the real challenge in liquid biopsies is not in the detection or sequencing, it is a sample handling and that is where QIAGEN fells. Also in Personalized Healthcare, we recently completed the PMA or pre-marketing approval submission to the FDA for a companion diagnostic paired with a novel medicine.
We are prevented by an agreement with our partner to say anything more about this project, but this is another milestone for us in terms of showing we can work effectively with Pharma partners and deliver an extensive U.S. submissions.
This also comes after the four positive FDA decision so far this year including our KRAS test paired with the colorectal cancer drug Vectibix from Amgen. Third, we are reaffirming our full-year goals for higher sales and earnings.
For adjusted net sales, we have tightened the original range to 4% growth at constant exchange rates and also tightened the range for adjusted EPS to $1.08 per share also constant exchange rates.
So in summary, we are pleased with the performance so far this year and we’re committed to achieving our full-year goals while preparing for further innovation and growth for 2015. I’m now on Slide 5, I wanted to share some perspectives on the sales development in 2014. As you know, we are working through the pressure on pricing in our U.S.
HPV franchise. Looking at the graph on the right side, the 35% decline in U.S. HPV in the first nine months of 2014 was in line with our full-year expectations for about 4 percentage points at top line headwind.
At the same time, we delivered a solid 9% growth at constant exchange rates from the rest of the portfolio in the first nine months of the year and this is also in line with our full-year goals. We will provide our formal guidance for 2015 in January, but as for some initial views, we have been saying publicly to expect U.S.
HPV headwinds to continue to at least part of 2015. Based on the current situation, this could be up to about 3 percentage points pressure on total sales for the full-year.
Some of you may be asking about the source of the renewed pressure, especially given that this product represented about 7% of total sales for QIAGEN in the first nine months of 2014.
The reason is that we are securing longer term market share while renewing customer contracts in light of the challenging pricing environment, which was driven by our competition. While we can often achieve a premium price based on proven clinical superiority of test general pricing levels have continued to drop substantially.
So this is expected to have an impact, in particular in the first half of 2015, but then we moved with this issue once and for all and as any change in pricing and volume from that level would not have a material impact on our overall financial results. Our U.S. HPV sales are expected to fall below 5% of our total sales in 2015.
At the same time, the rest of the QIAGEN portfolio continues to grow at a solid pace and the 6% organic pace excluding the U.S. HPV sales so far in 2014 provides a provisional baseline to consider going into 2015.
Once we get through this, the broader and more resilient QIAGEN portfolio, which spans some of the most exciting areas of molecular diagnostics and life sciences, is set to have a strong impact on the overall revenue base and become even stronger in 2015. I’m now on Slide 6 to provide an overview of results from our four customer classes.
Our Molecular Diagnostics customer class is leading the performance, growing 6% at constant exchange rates in the third quarter and at a faster 19% rate when excluding the U.S. HPV franchise and this was on a base of about 46% of our total sales. When you analyze these sales you have a run rate of about $550 million at this very high growth rate.
The gains in Molecular Diagnostics are coming from across our portfolio of growth drivers. We are seeing strong double-digit consumables growth on the QIAsymphony system also for our overall portfolio of profiling assays that are used for disease detection and monitoring.
The QuantiFERON latent TB test continues to deliver growth at its 20% annual target.
Our personalized healthcare portfolio has also been growing at a solid double-digit rate, and I want to note here that we saw significantly higher revenues in the third quarter of 2014 from companion diagnostic co-development collaborations along with gains and kit sales.
As mentioned previously, many of our collaborations are not announced, but even among those that we can make public 2014 has been a very good year for QIAGEN in terms of expanding our portfolio of partnerships and assay development programs and milestones.
The improvements were further supported by our decision to build an industry leader in bioinformatics through the combination of Ingenuity CLC and BIOBASE with our own activities and these sales contributions were across all customer classes.
In the life sciences, we saw improving trends against the third quarter of 2013 and also against the second quarter of this year.
In Applied Testing, we saw a return to high single-digit growth in both consumables and instruments and in particular strong demand for forensics and human identification products, following the launch of some new investigator assays.
In the pharma customer class, we saw higher instrument sales in the third quarter along with the similar single-digit sales increase at constant exchange rates from consumables and bioinformatics.
And in Academia, we’ve been seeing signs of improving customer sentiment including in the United States, but here we also saw a rather modest decline in instrument sales for the third quarter along with largely flat consumable sales.
The sentiment is improving, but keep in mind that funding levels are still far below level seen a few years ago and also that we have seen a shift in mentality, a much more cautious and prudent approach to spending that has taken hold in the U.S. and Europe. With that I would like to hand back to Roland..
Thank you, Peer. Good evening to everyone in Europe and good afternoon for those joining from the U.S. I’m now on Slide 7 and would like to review our results in more detail. In terms of adjusted net sales, we delivered 4% growth at constant and actual exchange rates for both the third quarter and for the nine months period.
And this is only a small currency impact; however, we expect this currency trend to become negative in the fourth quarter and I will touch on that later with our guidance.
For third quarter about one percentage point of total sales growth came from the CLC and BIOBASE bioinformatics acquisitions while about 3 percentage points came from the rest of the business including ingenuity.
And for the first nine months, the 4% constant exchange rate goal has been balanced between contributions from the bioinformatic acquisitions and the rest of the portfolio.
Adjusted operating income rose 7% in the third quarter at a faster pace than sales and resulting in the 50 basis points increase in the adjusted income margin compared to a year ago.
In terms of margin gains, we were able to maintain the adjusted gross margin at 72% and also absorbed higher R&D investments which were about 12% of sales in the 2014 quarter compared to about 11% a year ago.
Sale and marketing expenses also declined slightly compared to a year ago, while margin benefits also came from efficiency improvement in general and administration. For the first nine months of the year, we saw a similar trend in terms of adjusted operating income, generating an 8% improvement over the same period in 2013.
The adjusted operating income margin showed about 80 basis points of improvement in the 2014 period and that is after observing about 20 basis points of foreign currency pressure. So we are moving ahead towards our 2014 goal of at least 100 basis points of improvement from the 24.4% margin in 2013 under the new adjustment policy.
Moving down the income statement, adjusted income in the third quarter was up 6% with adjusted EPS of $0.27 at constant exchange rate and on an actual basis.
For the first nine months of 2014, adjusted net income improved at an even faster 8% rate with adjusted EPS of $0.75 at both constant and actual exchange rates and a steady 21% tax rate compared to the same period in 2013. I’m now on Slide 8 to review our adjusted sales in the third quarter by region and product category.
In terms of the region, the fastest growth came in the Europe, Middle East, Africa region, which delivered 30% growth at constant exchange rates in a broader stratosphere. The Nordic region and Turkey led the performance and we are seeing some improvement in Southern Europe as well.
This regional performance was included to revenues from a global customer agreement. Molecular Diagnostics sales grew at a double-digit pace in this region, but Pharma and Academia sales were slightly lower. The Americas declined slightly in the quarter compared to the third quarter of 2013 and this was due to the U.S.
HPV headwinds with this region growing 9% at constant rate, excluding that impact. We also saw an adverse impact on results in Mexico and Brazil from the timing of national tenders.
After relatively slow period in the second quarter, the Asia-Pacific / Japan region experienced a faster growth in the third quarter, delivering a 6% improvement at constant exchange rate. We saw a good overall double-digit constant exchange rate improvement in China, driven mainly by performance in Molecular Diagnostics.
Japan also grew at a good pace in the quarter and we were pleased with double-digit gains in Korea.
In terms of top seven emerging markets, results in the third quarter were disappointing and below the traditional double-digit constant exchange rate basis and thus delivering a 1% sales decline at constant exchange rates and providing about 40% of total sales.
On the positive side, we saw solid double-digit incremental work in Turkey, Korea and China along with growth in India, but this was offset by Russia as well as due to the timing impact of national orders in Mexico and Brazil.
In terms of product sales, consumables and other revenues, which includes bioinformatics sales, grew towards 3% at constant exchange rate in the third quarter and provided about 87% of sales maintaining at 20% so far this year of single-digit growth in this category.
Instrument sales advanced at strongest quarter periods in more than two years, delivering 11% growth at constant exchange rates and providing about 13% of total sales and this was supported by increased instrument service revenues.
Reagent rental agreements are on the rise who ongoing QIAsymphony system placements, especially in molecular diagnostics as we are moving toward our year-end 2014 goal of 1,215 total system placement. Moving to Slide 9, you have an update on our balance sheet and cash flow position after the first nine months of the quarter.
On the right side of the slide, you will see the improving trend in free cash flow during 2014, which was 18% to US$72 million in the third quarter of 2014 compared to the same – we had cash restructuring charges of about $65 million during 2013 and about $10 million of cash restructuring charges in this year, but beyond that we are generating significant improvement from efficiency programs.
We continue to have good liquidity and a manageable net debt position. This leverage remaining at about 1.1 times net debt to adjusted EBITDA. This enables us to support the third US$100 million dollar share repurchase program underway as well as maintain strategic flexibility. I would like now to hand back to Peer..
Yes, thank you Roland and now on Slide 10 to the review of a few of our growth drivers that continue to deliver a strong double-digit gain and now represent about 30% of total sales and we expect this increase to about 40% in 2015.
On the QIAsymphony automation platform, we are moving ahead to deliver 250 new placements in 2014, which would put us at about 250 cumulative placements at the end of the year making one of the most widely placed systems it’s not the most widely placed system for medium throughput molecular processing.
A key driver is the expanding menu of the addition of seven tests so far in 2014 in the United States and Europe on the Rotor-Gene Q that’s PCR component of the workflow with growth of about 20% at constant exchange rate and on track to achieve $100 million in 2014. QuantiFERON has already surpassed the size of our U.S.
HPV franchise and is now slated to top our global HPV franchise. We expect 20 constant exchange rate – growth rate into 2015 and beyond based on the strong demand for this product as a new goal standard for latent TB. The total addressable market for QuantiFERON is actually expanding. We have told you before about the U.S.
Preventive Services Task Force guideline, review that in underway in the United States and that will take a few years to be completed. We also mentioned that clinical data has been showing the need for testing a people with type 2 diabetes, both would have a big impact on the total addressable market for latent TB testing.
And in particular for QuantiFERON-TB Gold since it was the key test to demonstrate this.
The biggest impact and – what is new just as of Tuesday is the announcement this week by the WHO of comprehensive new guidelines for prevention care and TB control that now includes screening and treatment for latent TB infection to avert progression to active disease.
We applaud this decision which will affect more than 100 low and intermediate incidence countries and these include Brazil, Mexico and China.
As for the expansion of the total addressable market, we believe QuantiFERON is well positioned to take a leading role in this new strategy especially as we’re nearing commercialization of the fourth generation of this test.
I’m now on Slide 11, I want to give an update on our sample technology portfolio for use in liquid biopsies which is a new noninvasive technology that as an example is being used for detection of disease biomarkers and cancer.
I hope you understand the theory the focus is on target classes derived from blood plasma serum, cerebrospinal fluid, urine or other liquid samples. These targets are free circulating DNA being released from tumor cells, the circulating cells being shed from the tumors itself or the exosomes containing RNA that are being secretive from tumor cells.
This bar chart shows the explosion in publications on this topic. Liquid biopsies were a hot topic at the recent ESMO Conference in Madrid with a number of posters and peer review papers showing very positive results from using liquid biopsies to capture molecular insights that will help to treatments for cancer patients.
These can be in patients with diseases such as lung cancer where getting tissue tumor material can be challenging or and monitoring of patient after surgery to remove the tumor.
We have been expanding our industry leading portfolio, sample technologies during 2014 in particular during the third quarter with the launch of the new exoRNeasy kits to isolate exosomal RNA from Serum/Plasma even from a sample of small as one milliliter. Customers are using our portfolio to generating fascinating insights.
As one example, the pediatric hematology and oncology department at the Hanover Medical Center has been using these technologies and QIAGEN’s REPLI-g Single Cell Kits which make single cells accessible to next generation sequencing analysis to perform comparative studies of leukemia stem cells and controlled stem cells.
These new sample technologies will be coming in essential part of our pharma collaborations as you may have seen, AstraZeneca received a positive European regulatory opinion in September from the [cGMP] (ph) to include blood-based diagnostic testing for patients who could benefit from treatment with the lung cancer drug, IRESSA, but are unable to provide a suitable tumor sample.
We applause this development with our partner and look forward to advance in the use of these innovative blood-based tests to drive better treatment outcomes for patients. I am now on Slide 12, I want to share some views on the progress being made in our offering of next-generation sequencing universal solutions and bioinformatics.
A recent milestone was the integration of the 14 GeneRead DNAseq V2 gene panels, which form a wide range of cancer and translational research applications with our Ingenuity Variant Analysis bioinformatics solution.
This is a tangible milestone in achieving our ambition to offer universal products that address key bottlenecks, holding back the adoption of next-generation sequencing translational research and clinical diagnostics, as well as complete solutions such as the GeneReader workflow that is in development and on track for commercialization in the second half of 2015.
In this case, the bottlenecks to NGS are the need for reliable and proven gene panel. Studies are showing considerable variability among the different competitor offerings and the need to link assays to the highest quality data analysis and interpretation.
This slide shows you our comprehensive offerings to generate insights for different customer needs, ranging from basic discovery research with RNA and DNA, through to translational medicine requirements and then onto routine clinical diagnostics.
As we announced at the recent ASHG Conference, adoption of our universal bioinformatics solution is growing rapidly, as we continue to integrate and expand the capabilities and knowledge bases of CLC bio, Ingenuity and BIOBASE and bringing that together with the lab workflow solutions of QIAGEN.
And that is reflected and recently achieving a milestone of more than 250,000 human genomic samples having been used with QIAGEN’s bioinformatics interpretation solutions.
Next generation sequencing is not about generating gigabytes of data from the most technically advanced machine, so it’s about offering customers a range of solutions that provides a means to transform biological samples into valuable molecular insights.
And it is about those insights having an impact on treatment decisions or advancing our knowledge of a disease.
This is the motivation of our teams to move ahead and take advantage of our competitive strengths in the terms of sample technologies, leading clinical assay development capabilities, experience and automation solutions and leadership and bioinformatics.
Moving to Slide 13, I want to share with you some perspectives on our efforts to support public health agencies in the fight against the Ebola.
Here we are building on our proven capabilities as a leading provider of diagnostic and surveillance solutions in previous health emergencies, in particular the H5N1 and H1N1 influenza outbreaks, as well as the SARS and MERS respiratory syndrome outbreak.
Our teams are working closely with international organizations and research institutions in Africa and elsewhere around the world to provide testing components and automation solutions for Ebola virus detection. As one example, QIAGEN products are part of the protocol of the U.S.
Department of Defense, in particular the QIAamp Viral RNA Mini Kit that can be automated on the QIAcube and this is the most widely used protocol for Ebola detection in Western Africa. The screen shot from CNN in October shows the role of our product.
In this case, the Walter Reed Army Institute in Bethesda, Maryland and a particular QIAcube and assorted QIAGEN kits in the background. The WHO is using the QIAamp Viral RNA Kit in 15 African countries for Ebola testing. The Ebola test used by the DoD received FDA emergency use approval in August.
In addition, the DoD also relies on the QIAGEN EZ1 instrument and the EZ1 Virus Mini Kit for testing of non-U.S. citizens. The DoD has shipped these products to Liberia for Ebola testing and we are seeing demand from agencies in other countries that are sending teams to Africa. We’re working with the U.S.
Centers for Disease Control on how QIAGEN can further support their efforts as well and they have an Emergency Use Authorization in place using the RNeasy sample technology kit. We also recently signed an agreement for commercialization of complete test kits with our Hamburg-based partner, altona Diagnostics.
The test is already CE-marked and will be made available as part of a full QIAGEN solution through our commercial networks very shortly. This will enable QIAGEN to offer a full solution from biological sample-to-insight. We will provide updates on regulatory milestones when they are achieved.
Beyond these commercial activities, QIAGEN is supporting numerous activities to study the Ebola virus, including a project initiative by the Broad Institute and Harvard University in collaboration with the Kenema Government Hospital in Sierra Leone through donations and assistance to set up local testing infrastructures.
Of course, no one wants this deadly outbreak to become more severe. The business impact to-date has been modest and has not had an influence on our 2014 guidance. Given the unpredictable nature of the Ebola situation it would be inappropriate to speculate on potential revenue implications should be outbreak expand.
Moving to Slide 14, today we’re announcing the appointments of two internationally experienced industry executives to our executive committee. First, Dr. Laura Furmanski joined QIAGEN this summer in a newly created role as Senior Vice President of our Bioinformatics Business Area.
She is leading our rapidly growing presence in this area and is based at our QIAGEN Silicon Valley office. Laura joined from McKinsey & Company where she was a partner in the Silicon Valley office and worked with many med-tech and life science companies on a range of engagements. Manuel O.
Mendez was appointed as Senior Vice President of Global Commercial Operations in October. He is a 25 year veteran of life sciences and diagnostics industry. Having most recently served as America’s Executive Vice President at bioMeriéux, prior to that he held leadership positions with OraSure, Thermo Fisher and Abbott diagnostics business.
He has had a truly global career with assignment so far in the United States, Latin America, Europe, and Korea, and Japan. Manuel succeeds Benedikt von Braunmühl who chose to lead QIAGEN for personal reasons.
I would like to thank Benedikt for his outstanding contributions in Latin America and Europe and also globally and at most recent role and wish him all the best for his future endeavors. These employments show the ability of QIAGEN to attract top talent and further strengthen our international leadership team.
And with that I would like to hand back to Roland..
Thank you, Peer. I’m now on Slide 15 to review our guidance. For the full year we have tightened our adjusted net sales target to 4% at constant exchange rates, and this is in lined with our original 2014 guidance for about 4% to 5% constant exchange rate growth.
To the space and about 8% constant exchange rate growth from the portfolio excluding the U.S. HPV test with headwinds of about 4 percentage points from the U.S. HPV sales. Adjusted operating income is expected to grow faster than sales and generate at least 100 basis points of margin improvement.
We also tighten the range on adjusted diluted EPS through $1.08 per share at constant exchange rates, which is a mid-point of the 2014 full year range. These expectations do not take into account any further acquisition this year.
Like in January we announced adjusted EPS guidance at constant exchange rates in anticipation that sometime these would move against the dollar during the year.
Based on recent trends especially since September the dollar has strengthened against the euro and some other currencies especially in countries where they have rise in sales across our limited costs.
So we now expect modestly negative currency impact on full year sales of up to about 50 to 100 basis points and currency related pressure on adjusted EPS that could potentially be up to $0.01 per share.
For the fourth quarter adjusted net sales are expected to rise about 4% at constant exchange rates and adjusted EPS of $0.33 all to that constant exchange rates. This slide also contains adjustment assumptions.
For the full year we continue to expect about $120 million for amortization of acquired intellectual property and about $15 million for business integration and acquisition items. We also tied into guidance adjusted tax rate to 20% while the number of shares outstanding remains at about 242 million. With that, I would like to hand back to Peer..
Yes, thank you, Roland. I’m now on Slide 16 for a quick summary before we move into Q&A. We’re pleased with our performance during the first nine months of 2014 moving ahead on the initiatives to accelerate innovation and growth while working through headwinds created by the U.S HPV franchise. Let me review what we’ve announced.
First, we achieved our targets for the third quarter with higher adjusted net sales and earnings per share as well as a solid increase in free cash flow.
Second, we are moving ahead on initiatives to accelerate innovation and growth, especially among our growth drivers that are expanding at a solid double-digit pace and currently provide about 30% of total sales moving towards 40% in 2015.
They form a foundation for sustainable growth in the coming years, especially as we work through the final year of U.S. HPV headwinds in 2015. Third, we are re-affirming our full-year 2014 guidance for adjusted net sales and earnings growth over 2013.
We are committed to achieving our full-year goals and preparing our team for further innovation and growth in 2015. With that, I’d like to hand back to the operator to open up the Q&A session. Thank you..
Thank you. Ladies and gentlemen, at this time we will begin the Q&A session. (Operator Instructions) One moment please for the first question. First question is from Derik de Bruin of Bank of America. Please go ahead..
Hi, good afternoon..
Hi, Derik.
How are you?.
You’ve made some really good progress in the off margin this year, 100 basis points of expansion and I guess how should we think about that for 2015, particularly since the currencies I know will potentially give you some benefit.
And I guess just also from modeling purposes, how are you sort of thinking about the effects on the top line for next year?.
Roland, you want to take that?.
Yes, sure. Hi, Derik. Generally we still see that as a positive (indiscernible) we will create a few over the last 12 months to 18 months. And so, we want to believe that we’re able to continue that positive trend also into the quarter for 2015. Clearly it’s also to a certain extend depending to the revenue guidance which we are giving only next year.
Nevertheless, if you look on the different drivers for that, a couple of them are doing quite well. If you look on our [shared] (ph) service centers all the things we were able to do in administration, integration and globalization of all procurement efforts. So we feel comfortable at least on the bill funds.
And again you see it also now, finally, really pushing it’s too on the cash flow side, those things coming together quite nicely..
Next question is Daniel Wendorff with Commerzbank. Please go ahead..
Yes, thanks. Thanks for taking my question. And it’s actually relating the HPV franchise and Peer you mentioned that number of contracts were prolonged in the U.S. and this with broaden the first half 2015.
So my question on that is and how long do these contracts normally last? If I cut it right for the past, these were around two year contract, is that still valid?.
Hello, Daniel. So it’s a well, we’re signing every year hundreds of agreements that are coming up for renewal and they can extend anywhere between even out to one year I’d say the majority are some in the range of three years. And the important thing for us clearly this year is the competition has reached at the pricing levels.
That we’re actually able to secure very large portion of them, even now despite that the pricing is lower it gives us very strong market share and position also within these accounts for several years to come from which we can expand with other offerings.
So it’s typically in the range of a few years, the average duration assumed is around three years..
The next question is from Tycho Peterson of JP Morgan. Please go ahead..
Thanks. I guess question on Bioinformatics, you announced where we’ve seen your higher, you announced the Genomics England project and you’ve kind of integrated Ingenuity with the Cancer Research what mentioned.
So can you maybe just talk about a) the patient of Genomics England when that flows through the other still gaps you need to fill on the informatics side. And then see, just any feedback on Ingenuity with the Cancer Research Workbench solutions..
Sure. So in terms of the portfolio to started out with that we have an incredibly strong position in secondary analysis, which we are expanding through offerings the retailer to specific type of users be the cancer researchers or others.
So just for those you have never seen these types, the analysis, the secondary analysis of next-generation sequencing data is incredibly complex with many, many different ways to ultimately get to your at the definitional of what is a variant.
And we’re expanding and tailoring that to the different needs we’re already today have by far the largest offering in this base.
And so that position is one that we’re building from a real position strength and that will continue and very similar in the interpretation area where our knowledge bases are – were actually accelerating the efforts in this area to further broaden their capabilities and this is going at a very rapid pace.
What you saw for instance at ASHG is that we’re now starting to integrate them and not only the Ingenuity Variant Analysis or the Ingenuity Clinical systems with secondary analysis from CLC bio, but now also the HCMD franchises from BIOBASE and the problem in bioinformatics today is that there are many, many different tools but there are many small individual tools that are not aggregated.
We’re creating something very seamless for our customers targeted towards their applications. The response of the market is actually very, very positive.
So the seamlessness takes a lot complexity in interface management out of the system, which software is just deadly and systems continue to be upgraded and enhanced over time to ensure certain seamlessness is extremely valuable for our customers. Insurance is now large contracts.
We are very successful as obviously the key go to resource for interpretation secondary analysis that we have a strong – very strong and competitive position to offer. We have mentioned the 250,000 genomes that were for instance processed already or our genomic samples that were processed.
This compares to a few 100 or few 1000 that you see even in very large institutions. So this number 250,000 is a one that it is just miles ahead of anything else that is out there. And I think this puts us into a very strong position for large scale genomic analysis studies that for instance you’ve referred to before..
Your next question is from Peter Lawson of Mizuho Securities. Please go ahead..
Yes, just on the HPV business.
Where are you seeing the most pressures that from large competitors or small private companies? And then when do you think that business stabilizes?.
It’s very different in terms of the geography. So the HPV franchise ex-U.S. is actually doing quite well. We’re very successful. We’re winning almost every major tender where we’re moving ahead quite rapidly and develop, but also in less developed countries.
In the United States – and there typically in ex-U.S., we see competition many, many players, small players, but we are – by far the majority share player there. Situation in the U.S. is very different that we clearly have a oligopoly or few players basically in this market.
And what happened was that due to very poor uptick of competing tests, the pricing button was pushed and the pricing levels collapsed. And while we are still able to command a premium in many cases, it is quite clear that if customers have price of x, it is tough to charge to 2x. So, we’ve been forced to go along with those pricing levels.
Competition is in the States across the three other players basically that are on the market, really only two at the moment..
The next question is from Doug Schenkel of Cowen & Company. Please go ahead..
Hi, this is [Ryan Decker] (ph) filling-in for Doug. Couple on QuantiFERON.
How was the launch in China tracking relative to your expectations firstly? Number two, can you talk a little bit about QuantiFERON in Japan and how successful you’ve been in winning back those accounts that you lost previously? And lastly, can you provide any additional color on commercialization timelines for TB Plus? Thank you..
Sure. So the first question, QuantiFERON, China is moving ahead well. As you know, we were the key partner in all of the major studies that provide credits in groundbreaking, also clinical evidence for the Chinese market. Our product was a test of choice and therefore validated the benefits of our products quite impressively for the Chinese market.
So, this is moving ahead quite rapidly and the uptick of these large screening programs are even subgroup testing is typically – also here is something that you don’t see a step change suddenly happen but you start seeing an acceleration overtime to open to our plan this year, but we are fully in line with our expectations for the Chinese market.
The second question was on the Japanese market. In Japan, there was one disruption in 2013 that had to do with the supply chain being disrupted for certain period of time for the Japanese market which led to the loss of one account as described in Japan.
And we have been very successful in regaining share in the Japanese market altogether with that one exception, but the evidence is very clear now. In the meantime also been built that, I’ll turn it to solutions. Solutions are providing significantly superior results and I think that’s strong evidence.
It’s just a matter of time hopefully for this two to convert and we are doing all we can I think the rest of the world has clearly shown that the QuantiFERON solution is the way to go.
In terms of the QuantiFERON post generation product we are progressing very well on that product that had some unique new features, I will be to that for now, that also open-up new opportunities and new market segment and we will talk about as that launch nears..
The next question is from Isaac Ro of Goldman Sachs. Please go ahead..
Good afternoon and thank you. Question on liquid biopsy this is an area where I think you have been talking little bit more about the assess that you have and the opportunity for growth, that said it is clearly a lot about the technologies out there in the marketplace that could be disruptive.
So, how would you kind of put the opportunity in the liquid biopsy in context for your M&A priorities versus some of the other initiatives you had in informatics or sequencing for example?.
Sure. Well, see for us liquid biopsy is a sample technology basically the stability to enrich various scar some amounts of molecular targets from biopsy is that are more easily accessible than tissue.
And they are in that market, I am not really sure what you are referring to disruptive change but in the free circulating DNA area we have extremely a strong position in that area, and also in the RNA and the fixes more RNA I think we are basically only wide available products in the market today.
And so we are definitely working intensely to standardize sample technologies in these markets just like we’ve done in so many other areas of sample processing where we have shares of 56% to 70%. And this is the starting point for liquid biopsy processing.
We have not been active in circulating tumor cells and that might be what you are referring to, circulating tumor, tumor cells have some benefits, they also have some disadvantages and we see with a new molecular techniques that exosomes and DNA is becoming a method of choice.
Started out I think the cancer is going to bit a real opportunity to show the benefits of these technologies, currently a lot of the activities in the area of that been testing that has slightly different needs and that’s maybe on the long-term separate area not really a liquid biopsy as we would define it ultimately for diagnostic testing for instance for tumors.
In terms of the M&A if you ask is there something out there that would be interesting for us to acquire and lipid biopsies had struggled to find something that with the something that we would need to actually deliver on a very exciting future for our liquid biopsy franchise.
So that mean that the focus that we have in M&A is clearly along the growth drivers and bioinformatics was a big focus over the last 18 months, will continue to be, and we are, however, also looking at other areas and I think the news flow will then further validate that..
The next question is from Dan Arias of Citigroup. Please go ahead..
Afternoon. Thanks for the question. Just wanted to ask about the early days of the C. diffs as they uptake. How are you finding that market to be just given the landscape? And as a related question, if I could, it seems like CMV and MC, they both sort of need to have assays for hospital labs.
So I’d be curious just to hear how much bundling, if any, you’re doing there with those tests?.
Absolutely. I think there are two – you’re actually right that hospitals, it’s a cornerstone for hospital and the QIAsymphony provides an excellent testing platform for these medium-sized hospitals at it allows broad array of different tests including LDTs be on it. The same is true for cytomegalovirus.
That should be closer to patients as it is a monitoring assay. We are seeing a very significant interest in C. diff. We already converted first accounts. We have a very strong franchise already in CMV. We’re at CMV franchise since almost 10 years.
We were under an exception from FDA to continue selling the ASR prior to the approval of the CMV assay this year, which basically allows us now to convert the existing uses over into the PMA approved product. So CMV is not a new area for us.
It’s one in transplantation testing where we have an incredibly strong franchise and I think one that we’ll be able to talk more about and also going forward. There’s a lot of exciting things happening in this area.
And healthcare-acquired infection, this is simply and add-on to – at QIAGEN, need to provide value to the hospitals that are thinking about putting in some patient in that assay, also gives a certain amount of base volume that allows (indiscernible) fab..
The next question is from Zarak Khurshid of Wedbush Securities. Please go ahead..
Hi, there. Good afternoon. A couple of question on cash flow for Roland. How did the working capital improvement play into cash flow? And then how sustainable might that be? And generally how much does HPV contribute to cash flow? Thanks, guys..
Working capital improvement is a smaller part of it. It is clearly one part, but at the same time we see the majority coming from operational efficiency really about the project we started earlier in 2013 and finally I would say coming all the time and giving us quite significant impact here.
So I think there is clearly something where we believe also going forward we see even larger contribution coming from as we again typically towards these efficiency programs by starting and rolling it out on a limited area and then you take it over a region on to a global base, so that (indiscernible) controlled set up.
At the same time of course you’re creating larger impact on longer time period. The other thing what we of course to your second question around it’s re-contributions.
As (indiscernible) clearly still is a business with a good gross margin, at the same time you have to have in mind that still its part of our business which has two sales forces, as you know we have a clinical and laboratory sales force.
So in terms of actually in EBIT contribution, I would say it’s below company average and I think it is also something to have in mind and it’s also the reason why we are able actually to absorb quite nicely the impacts we are seeing here from the revenue side.
And at the same time with bioinformatics, of course we have a huge opportunity going forward, because bioinformatics to a large part has even a higher gross margin than we have seen and used to from those previous slides. I would say the product mix is also quite helpful for us..
The next question is from Vijay Kumar of ISI Group. Please go ahead..
Hi, guys, thanks for taking my question. Peer, I had a big picture question for you and I guess when you look at the (indiscernible), obviously you had a challenging time with some of the challenges in U.S. on HPV side. I guess the question is after 2015 right in resuming the HPV stabilizing.
I think the core part of your business has been doing high singles, right. And I think if you look at what the key growth drivers out there, it should have basely been QuantiFERON-TB and profiling within the molecular diagnostics. I guess given some of your comments on QTB were reasonable.
That market is expanding and 20% growth rate in QTB is a reasonable assumption but in the medium term I guess, what’s going to drive that strong double digits within profiling or other parts of your diagnostic business right? And to that extent how key is gene expert to the thesis? Thank you..
Sure. If you look at the portfolio, the diagnostics portfolio overall you saw very high double digit growth again in the third quarter excluding the HPV headwinds and these are significant degree of pricing headwind. So we still maintain very large number of accounts. Now this product is down to 5% or lesser sales going forward.
So I think we’re seeing stabilization probably happened over the course of 2015, which means at the rest of the growth, it seems to shine through and while clearly we’re fully aware this is an impact that we are moving through. And therefore, it also demands a certain amount.
Attention, if you look at the diagnostics portfolio, you have several hundred millions of dollars of profiling test and franchise that where you have the QIAsymphony now being the hardware for – or the carrier for all that and we are moving forward quite aggressively in an early stage of that product life cycle.
So we talked about four approvals in the state, but we have about 23 assays in Europe running on this and we just launched the whole hospital acquired infections portfolio in Europe and whole suite of STB products as well.
And are really charging ahead in the 60% of the world which is not the United States and in the United States we’re seeing very good uptake following the FDA approval.
That’s several hundred millions of dollars of opportunity that we basically have there and personalized healthcare, we talked about – I couldn’t imagine something more fascinating, we’re seeing the assay technologies, the platforms, even the software elements not come together.
We’re signing up record agreements that couldn’t image anybody having even – even though the number of partnerships that we have in molecular field and which will be proven to capabilities also in the regulatory front in the U.S. but also globally. And so that franchise doesn’t need now a rocket or an engine or anything.
This is a very long-term growth driver in QuantiFERON certainly as well that has already proven very high growth rates and will continue going forward as we expect to do so as well. So if you just drawn the map and see HPV starting to lose its headwind impact, the growth profile is actually quite attractive.
And if you would look at individual market segments, significant premium even compared to what we see from other players in this space. So we are aggressively funding growth drivers in the long-term even on the medium-term and they will have an impact even on the medium-term on the growth profile and the profitability of the company.
Because as was mentioned before clearly if you have a headwinds on HPV that also has an impact on the operating income and cash flows question just alluded to before and that’s something we are working through as well.
And that will hopefully then move out of the picture in 2015 and obviously 2015 with a number of different launches only mentioned Next-Gen, but there are 100s of other things that are coming forward in this area as well, I think it could be an exciting year for us..
Next question is from Dan Leonard of Leerink. Please go ahead..
Thank you. Another one on HPV, so for U.S. HPV to be a three point headwind in 2015 that seems to imply another decline of about 40% year-over-year. So my question is one is that, is that math right? And then two as you look now your budget for 2014 and U.S.
HPV is coming in, I think was there any plant, is there a primary – you have a number of growth drivers, but is there a primary offset you’d put on the pedestal to say that this offset the decline in HPV..
We expect the declines to be pretty similar to what it was this year, so we had a decline this year plus or minus 30%. And the decline was to a significant degree pricing.
If you assume that that would continue for a certain period of time if these pricing levels have been set at a certain level, we’re not seeing dramatic declines anymore that was kind of like a step change, in particular, one competitor and then another following.
That is kind of like floor at a level which is really not far away from commenting another test which kind of gives you a sense that this is – may be a level where you wouldn’t see a similar step change, at least certainly not in terms of dollars.
So from that perspective we’re actually fully in line with our targets for this year, came in pretty much as what we had predicted for the year, also in terms of overall headwind.
But offset set is, if you look at the third quarter, you see almost 20% growth in the molecular diagnostics franchise, ex-HPV you see a very, very strong underlying growth which kind of like sometimes is not in the limelight, because we see QuantiFERON is a very strong $100 million growth driver and we see HPV as a negative impact.
But just personalized healthcare and the profiling portfolio primarily symphony are very strong growth drivers..
Next question is from Jeff Elliott of Robert W. Baird. Please go ahead..
Yes, thanks for letting me in here. First one on the instrument growth, as you mentioned really strong growth there, as far as that we seen it sometime.
It was some of the pull out from the fourth quarter, I guess what’s behind the growth and how stable is that?.
Excuse me the audio was not – didn’t work could you repeat the question? I’m sorry. .
Yes, the question is on the instrument growth in the third quarter, like you said as strong as we’ve seen in sometime with some of this pullback we had from the fourth quarter, or what’s behind the growth you saw in the third quarter?.
No, I think you sensed from the call in the second quarter that we were that’s a good cash. We were quite satisfied with the instrument performance moving into the second half of the year, we made some changes in the way we managed the funnel and also in the way the instruments are packaged to our customers.
So we’ve started to see a reemergence in growth in terms of the assay portfolio and new assays coming online that are reinvigorating growth of instrumentation sales. So, I’d say that is more an execution issue. The teams have been doing a very good job since a few months managing that tunnel..
Next question is from Gunnar Romer of Deutsche Bank. Please go ahead..
Hi, good evening, guys. Thanks for taking my question. First one would be to Roland on the likely FX impact on your top line next year. I think this question was already asked earlier, but I probably missed the answer.
So what would be your best guess given current spot rates? What the impact on your top line would be next year? And then, if I may have a second question on the companion diagnostics pipeline, how should we be thinking about that pipeline evolving into next year and potentially translating into, say, when you would be expecting the first significant contributions here?.
It’s Roland. Good question. Gunnar, of course if I take Deutsche’s expectations and we have still a significant drop to expect, but putting that aside if you would use current rate, I actually don’t think it will be too much of them over all topic for us.
We probably have it in a – impact that you will see on the warning side, not necessary in terms of changing our overall growth rate, which is also reason why we look at constant exchange rate go for it on the revenue side, which makes it then very transparent in terms of what is overall growth rate going forward on the revenue side.
On the profitability side, I would say probably it’s helpful of course on the modern side. It’s the question on the absolute dollar side. It would stay as it is right now. It is probably also something, which is more on the warming, might be $0.01, might be $0.02 on a full year basis.
So this year if you see so far for the nine months period it small as nothing and we expect now up to $0.01 for the remaining quarter. Again, I’m not too pessimistic on the currency side.
Our natural hedge on the profitability side is actually working quite nice, duplicate it only by this event if you see one specific country see on Brazil, see on Turkey as Australia.
And so those significant development in a typical key areas, but typically that’s also brought out on a global basis as some other countries who are in a different direction. So again we have to mention it and we do so, but at the same time I think it very well manageable from our perspective.
Yes, I think it’s a very specific profile that we have as an overall company. Back to your first question, how do we see the revenues typically we can. So again to reiterate there as you guys pre-components within that personal healthcare portfolio a part of it for the minority it’s a – that are service related revenues.
The development a milestones that we are able to achieve, that sometime difficult for us to manage you can usually have the percent maybe even 2% related inorganic growth, sometimes floating up and down for an overall companies or easily $5 million to $6 million up and down per quarter.
In terms of the development milestones, that doesn’t really mean much these are multi-year programs and we’re typically paid on the specific milestones to offset the cost of developments.
And then we have the part of majority is consumable and assay and instrument related and that is a very fast growth on our portfolio and together approaching $100 million.
This is a very important large franchise for us that typically then you generate revenues when the assays kick in where less interested in the development milestones as more an opportunity cost protection, in case the program is discontinued. We charge cost plus here with the assays however that as where we effectively can scale on a global basis.
And there we already have our 20 assays in Europe we have now for in the states that are approved and we are moving forward quite aggressively and building that menu.
Again, we just filed the further PMA that we can’t talk about the majority of our partnerships as we can talk about and as you just see the headline numbers tip of the iceberg that is already quite impressive..
The next question is from Tim Evans of Wells Fargo. Please go ahead..
Hi, thank you. I was hoping that might ask a little bit more about the strength in the instruments, particularly in the pharma customer base. Can you talk about a little bit more about the dynamics there and maybe also by geographic region..
Sure. If we talk about pharma, it’s predominantly U.S. into certain degree of the Europe, but in particular if we look at instrumentation in the third quarter of this year and hopefully this will secure into future period, instruments as always a little bit more a lumpy business spending on the instrument the capital cycles and the budget cycles.
But effectively taking the portfolio that we have and it’s a very, very good portfolio across sample and assay technologies.
We simply improved the final management in this area and focused more on the instrumentation side versus in the first half of the year where we’re more focused on some of the reagent and the new assays that were coming in the next-gen sequencing portfolio, and others that are actually doing very well.
And so with additional resources on the instrument funnel, starting in the second quarter of this year moving into the third you start, you hopefully see the first times here in the third quarter and you look forward to further success in that area..
The next question is from Paul Knight of Janney Capital Markets. Please go ahead. .
Good evening.
What are the other target growth rate on the personalized medicine business or what should we really think for on a multi-year period, is it contract-by-contract or should we assume 20% type growth, what’s your thought on the business plan?.
If you look at the overall revenue in that area, it can be anywhere between 20% to 30%, is related to development mile stones. And we don’t expect this to grow at very high growth rates and we’re scaling like crazy in the Manchester side that we have, where we already have a couple of 100 assay developers.
And for those of you who know the industry, this is probably one of the largest assay development sites in the world. And we’re scaling with quite aggressively that capability there. But that won’t grow at the same growth rate as scalability of a kit sale and an instrument or reagent sales to pathology labs.
So be the real-time PCR, or be the next generation sequencing panels, or be it the related equipment and consumable for that, we see a very strong growth opportunity for this and we’re in the early days of personalized medicine.
We’re not playing it for 2015 and 2016, these are growth rates that we assume are well in the double digits, but we’re planning it for, also here this is a very long term high growth driver for us, just like QuantiFERON, just like QIAsymphony, just like Bioinformatics and just like NGS.
So we’re lining up multiple growth cylinders that have multi-year perspective and funnel them and fueling them aggressively..
So, thank you very much Peer and with that I would like to close this conference call, and thank all of you for your participation. If you have any questions or comments, please do not hesitate to give us a call. Thank you very much..
Ladies and gentlemen, this concludes the QIAGEN’s Conference Call. Thank you for joining, and have a pleasant day..