Peer M. Schatz
Analyst · Piper Jaffray
Yes, thank you, Roland. I'm on Slide 10, where you see the goals for 2013 and how they build on the achievements for 2012. Our top goal is to accelerate growth through expansion of our current business portfolios, as well as with targeted acquisitions, such as with Ingenuity. We will continue to consider these types of acquisitions that fit with our strategy and strength in our molecular testing ecosystem. And as we mentioned earlier, we are working on key assays submissions for 2013 and '14, particularly to expand our menu in the United States, as well as the range of content available on QIAsymphony across all customer classes. This focus on improving the top line is accompanied by a commitment to improving profitability. This includes concentrating operations at locations with strong critical mass. Based on the KRAS and EGFR submissions, we have begun to consolidate all regulatory activities into a global hub at our Manchester site. We have built great expertise for even the most complex submissions there, so we decided to create a seamless verification and validation process for the final stages of development at this site, particular for assays on QIAsymphony. As a result, the site in Hamburg, Germany is planned to be closed, and these activities move to Manchester. We are continually evaluating additional projects to implement in 2013, designed to improve our efficiency and effectiveness, while also freeing up resources for growth initiatives. And these projects could result in additional restructuring charges. We are moving quickly and expect the majority of the restructuring efforts to be completed by the end of the second quarter. We also recently launched a new version of the QIAGEN website, a highly interactive site that includes a new e-commerce channel. In summary, we have begun 2013 with a clear focus on accelerating innovation and growth in the coming years, as well as improving our efficiency and effectiveness. I'm now on Slide 11. In Personalized Healthcare, we have reached $100 million of sales in 2012, and we are moving ahead in 2013 with growth driven by contributions from assays, co-development project revenues and other products used for biomarker analysis and development. As I mentioned earlier, we are actively signing Pharma collaborations, such as the broad agreement with Eli Lilly in February. This type of master agreement provides a framework for collaboration across many therapeutic areas and will significantly streamline the discussions to get started on new projects. In terms of pending regulatory decisions, we are working with the FDA on the review of our therascreen EGFR test, which was submitted as a PMA in late 2012. This companion diagnostic is designed for use in patients with non-small cell lung cancer and paired with afatinib from Boehringer Ingelheim. The 6-month priority action date is in the third quarter of this year. Once we receive EGFR in the United States, we will then be able to offer regulated assays for the 2 big biomarkers, KRAS and EGFR, in the 3 largest Pharma markets of the United States, Europe and Japan. Even in light of the reimbursement issues, which I touched on earlier, the launch of the therascreen KRAS test for use in patients with metastatic colorectal cancer is gaining momentum. Our #1 priority has been converting labs to our test. We announced, in January, a big step forward with Clarient adopting the KRAS test. Clarient has a customer base of more than 2,000 pathologists, oncologists, clinical laboratories in the hospital. So this was a signal of the market moving to adopt FDA approved tests. I'm now on Slide 12. As I mentioned earlier, we were very pleased with the response from customers to the unveiling of our NGS workflow at the AGBT conference in February. Booth visitors, many of whom are involved in clinical research and diagnostics told us how the appreciated the streamlined and automated workflow features that QIAGEN is developing and will accelerate their adoption of NGS. We have been developing this workflow with these types of customers as our top priority, not trying to repackage our product actually designed for other customers as a secondary action. Marco Island reaffirmed that we are on the right track. Our solutions are designed to address many of the challenges brought up by our customers. These include too many manual processing steps, having to rely on various vendors to get the job done and batching samples to get cost-efficient runs. And the integration of Ingenuity into our ecosystem shows we're addressing their concerns about the time and cost required for high-quality interpretable results. So our ambition is to introduce a differentiated, next-generation sequencing workflow that will drive faster adoption of this breakthrough technology in new areas. Our development program is moving ahead, rapidly backed by significant investments, and we are on track to have the first placements with select customer groups in 2013. Turning to Slide 13. As you think about the sheer volume of sequencing data today, it is clear that the interpretation of biological information, not just generating it, is extremely important, and with the acquisition of Ingenuity, we are going to integrate the, by far, leading resource for biological data interpretation as a cornerstone of our molecular testing ecosystem. In only a few years, as you see on the right graph, the amount of sequencing data accumulated by 2015 is estimated to fill about 1.5 billion DVDs. So generating molecular information from a biological sample, whether through a real-time PCR piracy cleansing or next-generation sequencing, is certainly not the only need for our customers. More about the focus -- more of the focus is the shifting to generating data and providing the highest quality interpretation in a seamless workflow. I'm now on Slide 14. As I just mentioned, the volume of sequencing is growing rapidly, but interpreting the result remains a major bottleneck for NGS adoption. This chart is from a Yale University study and it shows how the interpretation of biological information is going to grow as a share of the overall sequencing costs. And on this topic, Dan Koboldt of MassGenomics made and insight for comment on the 10 Commandments about a next-generation sequencing. He said users should a member the cost of analysis when thinking about NGS expenses. "Otherwise," he said, "your sequencing data, your $1,000 genome, is about as useful as a chocolate teapot." In fact, the amount of time required for interpretation can quickly amount to many days, even for limited genome panels, because of the complexity and size of the data. Larger data sets are exponentially more challenging and require even more time. While there is currently a lot of attention on reagents and platforms, customers are, for this reason, increasingly turning their focus to interpretation of the resulting data. And by seamlessly embedding the leading interpretation resource into our ecosystem, we create a push-button experience for our customers from a raw biological sample to valuable molecular information that provides interpretation and insights for scientific or clinical recommendations. While the model and the projections given for Ingenuity are based on the standalone business model, our real purpose is to create synergies across our portfolio that includes NGS assays, reagents in platforms in the Life Science and Diagnostic segments. Together, we are going to create seamless solutions for our customers to link the world's leading resources for interpretation of biological information into QIAGEN's extensive range of platform technologies and content to drive signs throughout development in clinical diagnostics use, and doing so positions QIAGEN as a unique player with a content and interpretation-centric ecosystem to serve the continuum of customers and their needs from basic research through to clinical diagnostics. We are therefore taking the value proposition of this next-generation sequencing era into new step. You will hear more as this unfolds. On the basis of this vision, the team of Ingenuity is excited to be joining QIAGEN. I'm now on Slide 15 to provide you with an overview of Ingenuity, which is a privately held company in Silicon Valley. I'm delighted to welcome Jake Leschly and his team to the QIAGEN. They have done a fantastic job in developing the market for analysis and interpretation of biological data and we are excited about the opportunity to form an industry-leading, content-centric ecosystem of molecular testing solutions. In biological analysis and interpretation, Ingenuity clearly stands out as the best-in-class. The foundation of Ingenuity's product portfolio is the Ingenuity Knowledge Base, a 14-year, high-investment effort to accurately, manually create and model and computationally structure the vast amount of biomedical literature in the world. The key to Ingenuity's superior position, reflected in their sales being about 2x to 3x higher than the next competitor, is a perfect process, one that is supported by advanced tools and algorithms that make it possible to standardize data from a vast range of resources and make it comparable, linkable and inter-operable. In fact, the knowledge system already includes all of the existing genomic variations implicated in human disease and thousands of disease models. I want to stress here that the process is designed to handle the growing volume biomarker data and to provide customers with premium insights much with faster than with other resources. Thousands of users in more than 600 leading institutions and companies around the world, particularly the leading genomics labs, as well as pharmaceutical companies are already some -- and already some diagnostic labs are already today Ingenuity customers. Ingenuity's applications, which can be used with biological data generated from any system, are accelerating scientific discovery and enhancing patient care by providing rich, accurate and visual insights into complex biological systems. As we discussed, one of the value propositions of this acquisition is to embed Ingenuity's dry lab interpretation solutions into a wet lab molecular assays. Many of you know that we have successfully built exactly such a franchise with our GeneGlobe molecular assay content portal, which offers hundreds of panels for PCR and next-generation sequencing applications, as well as more than 60,000 fully annotated assays for the most sought-after diseases. So the opportunities with GeneGlobe and Ingenuity are going to be fascinating. I'm now on Slide 16, and would like to provide some additional insights into Ingenuity's competitive advantages in the market landscape. Ingenuity brings an unprecedented combination of an extensive database, with intuitive applications designed to give answers across all interpretation needs and not just provide customers with standalone applications that need to be assembled into a comprehensive solution. There are different types of biological data analysis products currently being offered. Some of these use open software systems, while others rely on computer-automated curation. And others may offer expert curation, meaning it has been reviewed by scientists, but only for a selected narrow disease or pathway scope. Our decision was to add a comprehensive biological interpretation system covering all biomarkers, pathways and diseases, and that is why we have a new valuable resource with Ingenuity. What makes Ingenuity, which has, by far, the leading market share, as I said, over this fast-growing market? First, Ingenuity offers a deeper and broader understanding of biology than competitors. The superior quality of this content, which has been built up over the last decade, is, in particular, due to the involvement of scientific experts and key opinion leaders who add manual curation and quality control. This is lacking at competitors. Minute differences in quality in the database can make huge differences in scientific or clinical interpretation because the data is quite complex. Beyond the content, customers also say Ingenuity's products are much easier to use. So we see Ingenuity's Knowledge Base and intuitive applications providing a sustainable competitive advantage for years. Moving to Slide 17, you see an overview as to how Ingenuity unlocks the value of biological information. What customers have come to appreciate is that Ingenuity's Knowledge Base is built on algorithms that pair all human gene variants with biological interpretations based on known outcomes and findings. These pairings are collected and reviewed by experts to create standardization from a wide range of sources. These include clinical and scientific publications from around the world. The sophisticated process of standardizing the data and the associated learning algorithms translates the broad range of source data into inter-operable and linkable collections of relevant information. Customers choose from different applications for the biological data interpretation. IPA is the industry gold standard software application that enables researchers to model, analyze and understand the complex biological systems at the core of the Life Sciences research. So this is critical for pathway analysis. iReport is an interactive web-based report optimized for gene expression experiments from RNA. micro array and real-time PCR platforms. The tool for next-generation sequencing is Variant Analysis. It answers a critical need for researchers trying to rapidly identify relevant comparable variants in human diseases in a matter of hours. Customers can drill down to a small subset of the compelling variance and also interrogate variants for multiple biologic perspectives. Ingenuity is also developing a product that we believe has significant potential to help in this adoption of next-generation sequencing in diagnostic settings. These new product offers an optimized and scalable solution for interpreting and scoring clinical variants identified by sequencing-based molecular diagnostic tests. Ingenuity has been actively forming relationships with diagnostic and reference labs to bring the power of this technology to new customers. The market leadership of Ingenuity's products grows out of a long-standing commitment to ensuring the highest standards, particularly through expert teams to create the highest quality data and supported by the most advanced technology. As part of QIAGEN, we will strengthen this leadership position and, in turn, reap benefits of significantly improving the value proposition of our molecular testing ecosystem to customers. With that, I would like to turn over to Roland.