Peer M. Schatz
Analyst · Commerzbank
Yes. Thank you, Roland. I'm now on Slide 10 to provide an update on the progress we are making on initiatives among our 5 growth drivers. Our strategy is anchored on expanding our leadership in Sample & Assay Technologies that address the rapidly evolving needs of customers to transform biological samples into valuable molecular insights. The 5 growth drivers are delivering strong double-digit constant exchange rate sales gains and currently provide more than 1/4 of sales. We expect this share to increase as we reallocate even more resources to further accelerate their momentum. With the QIAsymphony automation platform, we are moving ahead towards our goal of 250 new placements in 2014, building on the more than 1,000 installed systems at the end of 2013. We already have 4 FDA approvals this year: 2 large PMA approvals in May alone; and plan for more in 2014. QuantiFERON is set to break through $100 million of sales in 2014 and has already surpassed the size of a U.S. HPV franchise, providing more than 8% of total sales. Personalized Healthcare is growing on a base of $100 million in annual sales, thanks to higher assay sales and growing revenues from the companion diagnostics co-development agreement. Bioinformatics is an important incremental contributor this year as we create an industry-leading portfolio anchored by the combination of teams and products from Qiagen, Ingenuity, CLC Bio and BIOBASE. And on NGS, we are launching new Sample Technology kits, as well expanding our offering in combination with bioinformatics. Together, we see these activities as having had more than $50 million of annual sales in 2013. Our teams are also moving ahead on development of the GeneReader NGS workflow, and as we announced with the first quarter results, market entry is anticipated in the second half of 2015. I'm now on Slide 11, which provides an overview of some selected new product approvals and launches during the first half of the year. First, we are very pleased with the progress to expand the test menu in the United States through clearance of the full QIAsymphony RGQ MDx system earlier this year and then the clearances of artus C. difficile and cytomegalovirus kits. The C. diff test is a key foundation of our healthcare-acquired infection portfolio, which is planned to also include the artus VanR, QIAsymphony RGQ kit for detection of vancomycin-resistant bacteria and the artus MRSA/SA QS-RGQ kit for detection of methicillin-resistant and susceptible Staphylococcus aureus infections. Customer response to the C. diff test, which is also available in Europe, has been very positive. A key differentiator is the clinical profile of our assay given that it detects both toxin A and B genes, which is important since either toxin can cause this potentially life-threatening infection. The vast majority of the competitive assays only detect one, so they may miss some positives. There is also an economic value proposition given the broad portfolio coming on to QIAsymphony that enables multiple assay consolidation on one platform. The workflow is fast, providing up to 24 test results in a few hours and with capabilities to flex into much higher Sample numbers as well and with very competitive pricing. The approval of our artus CMV assay in May was another key milestone. This was a full PMA, a very onerous clinical trial and a multiyear regulatory process. CMV is a key assay for our QIAsymphony family as it represents a cornerstone in transplantation testing and one that many laboratories also in decentralized settings would very much like to perform. It has many advantages over the older marketed competitor test and then these are leveraged very well with the additional benefits of QIAsymphony in terms of automation, menu and total cost of ownership. We have a number of further new product approvals and launches planned for 2014, and we will keep you updated on our progress. I'm now on Slide 12, where I would like to provide some views on how QuantiFERON-TB is expanding its position as the modern gold standard for latent TB detection. QuantiFERON-TB is increasingly well positioned based on 3 major drivers: cost, accuracy and ease of use. Our assay has significant cost advantages over the competition because it can be easily run in-house and offers economies of scale. And this is why you see competitors having to offer a service business model to compensate for the complexity of their test. In terms of accuracy, the U.S. Centers for Disease Control recommend choosing the test with the highest specificity, and that would clearly be our test with a 99% level. These are among factors that make QuantiFERON the most widely used modern latent TB test and leading to penetration gains in the U.S. and elsewhere. Among developments in the quarter, there was an interesting study published in the Open Forum of Infectious Diseases in late June that discussed the estimated prevalence of TB infection based on the activities of the New York City Department of Health and Mental Hygiene, which has been using our test since 2006. With about 70,000 tests in this study, this is the largest study to date involving a growth [ph] test. The results showed that the patient characteristics associated with positive test results were consistent with known TB risk factors. The authors also said the results showed IGRA test, here meaning QuantiFERON-TB, since it was used in the study are reliable for TB infection -- detection. Beyond New York City, all of the other leading Big City TB programs, including San Francisco, San Diego and Los Angeles use QuantiFERON as their standard test. Also of note was an announcement in early June by the U.S. Preventive Services Task Force, or USPSTF, which is responsible for primary healthcare screening guidelines in the United States. They released a draft research plan on screening for latent TB infection and invited public comments through early July. The resulting evidence report will take some time to be created and will form the basis for any new USPSTF recommendations. We see this as a very positive step towards greater awareness about the public health threats of TB and how QuantiFERON-TB can play a role in detection. I'm now on Slide 13 for a quick update on our Personalized Healthcare portfolio and in particular, 3 recent developments. First, we announced in May a fourth collaboration with Eli Lilly to codevelop assay panels that can simultaneously detect DNA and RNA biomarkers targeting multiple cellular pathways involved in common types of cancer and associated with various development projects at Lilly, with whom we have a master collaboration agreement. Certain applications in biomarker development for tailoring oncology therapeutic require a combined simultaneous analysis of DNA and RNA, and this collaboration uses a multi-model, multi-analyte solution that can process multiple Sample types and biomarkers in a single test. Some of the assays will be based on the Modaplex platform, which has an FDA 510(k) clearance and became part of Qiagen through the acquisition of the PrimeraDX, a Boston-based company. The acquisition price was very low and related to the Lilly collaboration. In the meantime, we're seeing very strong demand from other Pharma partners for similar agreements, in particular since Modaplex enables so-called multi-modal rapid and cost-efficient DNA and RNA analysis that is not possible with other technologies, including next-generation sequencing. Our top priority is to address the needs of our Pharma partners and also those of pathologists as well. And we are not wed to any one type of technology platform to get the job done for our customers and patients. Second, AstraZeneca and QIAGEN just announced the other day a new collaboration to develop a blood-based diagnostic test to identify patients who are suitable for treatment with IRESSA, AstraZeneca's therapy for non-small cell lung cancer. We already provide the FDA-approved therascreen EGFR test that is based on a tumor sample from a surgical procedure, and this test is used in Europe and elsewhere in combination with IRESSA. Liquid biopsies will provide now a noninvasive way to gain molecular insights into a patient's EGFR and mutation status, especially if there is no chance for an operation. We have a strong leadership position in the liquid biopsy area, with success defined by the combination of a clinically proven assay with technologies for sample collection and processing, an era of unrivaled leadership for QIAGEN. Third, as you also saw during the quarter, we also gained FDA regulatory approval for our therascreen KRAS test in combination with Vectibix from Amgen, and this approval is tied to the label change for this medicine for first-line use in patients with wild-type KRAS metastatic colorectal cancer. This marks our third FDA approval for a companion diagnostic. And as the last point, we have been expanding our portfolio of biomarkers, building up our intellectual property rights, in particular, 4 new biomarkers in the area of blood cancers. These include the calreticulin, or CALR, and SF3B1 and they are included in the GeneRead DNAseq Leukemia V2 gene panels for next-generation sequencing. Moving to Slide 14, this gives you an overview of our expanding next-generation sequencing portfolio, particularly in terms of universal solutions that can be used with any biological sample, any sequencer and with any sequence data. As our teams develop GeneReader, we are pushing the expansion and commercialization of our next-generation sequencing product used to prepare sample for sequencing and then bioinformatics for analysis and interpretation. In terms of Sample Technologies, in which we help our customers to collect, process and extract nucleic acids from biological samples, we have already launched 10 new kits this year, including 4 in the second quarter alone. We are seeing strong customer demand for the REPLI-g kits that are quickly becoming the technology of choice for single-cell processing for next-generation sequencing analysis. And we are also seeing growing interest across our liquid biopsy area, such as cell free DNA and Exosome processing. In terms of exosomes, we just launched a first kit that is designed to enrich these tiny vesicles found in blood samples and then to extract the nucleic acids that they contain. Our teams are also developing and expanding the range of bioinformatics solutions offered by QIAGEN. We announced during the quarter the integration of some content from BIOBASE, a privately held German company that we acquired into Ingenuity Variant Analysis. The addition of this expert-curated content from BIOBASE is an exciting expansion of our offering. One of the BIOBASE databases is HGMD, the Human Gene Mutation Database, which is the gold standard for comprehensive data on human-inherited deceased mutations. PGMD, or the PharmacoGenomic Mutation Database, is another database that enables the identification of all published gene variants that have been shown to affect drug response in patients. These solutions are also being integrated into Ingenuity Clinical, our forthcoming web-based solution designed to deliver faster, easier-to-use and high-confidence clinical interpretation and reporting of insights from sequencing-based tests. We will have more to share later this year on Ingenuity Clinical and our commercialization plans. Moving to Slide 15, I'd like to highlight the new GeneRead DNAseq V2 cancer gene panels that we recently launched for use with any sequencer. We have launched 14 new gene panels that encompass 570 clinically relevant cancer genes. They are customizable to include other genes or gene regions of clinical or biological interest and are compatible with any sequencer. There are 3 categories of panels: focused panels with 8 to 25 genes; disease-specific panels for 40 to 50 genes; and comprehensive panels containing up to 160 genes. These new panels lead in terms of portfolio breadth and specifications. These benefits were made possible by the very deep molecular content in our GeneGlobe assay biosciences portfolio, as well as our assay development expertise, including the development of regulated diagnostic assays. In addition, we're leveraging our bioinformatics franchises by integrating them with these panels, thereby adding significant value for users seeking fast and high-quality interpretation. One misconception that we hear from some in the financial community is that gene panels are all essentially the same, and that is clearly not the case. We actually see this step, the sampling, extracting and enriching of genes of interest, as one of the most critical steps in targeted sequencing. As you see on the bottom of this slide, the QIAGEN GeneRead version 2 panels offer a very competitive profile on many metrics. For example, customers can work with as little as 10 nanograms of DNA input with our panels while turnaround time is also very efficient and the panels are offered at a very competitive price. With that, I would like to hand back to Roland.