Jay T. Flatley
Analyst · JPMorgan
Thanks, Rebecca, and good afternoon, everyone. I'm pleased to report that Q2 was another exceptional quarter for the company. Our business demonstrated strong underlying trends in every geography in nearly all product lines. As a result, Q2 revenue grew 23% year-over-year to $346 million, our 7th consecutive quarter of sequential revenue growth. Total microarray revenue increased 3% year-over-year, due primarily to the impact of BlueGnome. Demand for arrays remain stable as the market trends toward large sample numbers with moderate content at a lower ASP per sample. In fact, Q2 is the third quarter in a row with Infinium orders exceeding 1 million samples due to demand for our Infinium, OmniExpressExome, Core Exome and Omni2.5 products. We will begin shipping a new custom onco array in the second half of this year to early access consortium members interested in understanding the genetic basis of cancer. The onco array is the next generation of the groundbreaking iCOGS custom array that was used by the collaborative oncological gene environment study to identify genetic variants related to breast, ovarian and prostate cancer. The onco array contains approximately 600,000 markers for use in a meta analysis of over 400,000 samples. We plan to offer this array to non-consortium customers in 2014. The consumer market continues to show a significant elasticity below the $100 price point, generating strong demand for gene mapping services and our iSelect custom arrays. For the second quarter in a row we received a large consumer order, deliverable over several years and we continue to project close to $50 million of consumer-related revenue in 2013. Turning now to our sequencing business, total sequencing revenue grew 33% year-over-year, driven by strong demand for consumables and HiSeq instruments. During the second quarter, sequencing consumables grew 26% over Q2 of last year as a result of our larger HiSeq and MiSeq installed base, as well as growth in our Sample Prep business. Q2 Sample Prep shipments grew close to 50% year-over-year, with strength in both the Nextera and TruSeq product lines. While Sample Prep is a competitive field, our broad portfolio of supported applications and sample types has allowed us to gain market share as we launch new offerings in our installed base growth. Two of our newest products, the TruSeq Targeted RNA kit and our Nextera Rapid Capture Exome are seeing significant early interest. Our focus on Sample Prep has resulted in a portfolio of products with improved ease-of-use and a more complete user experience. One of our core strategies is to provide customers with the complete capability to go from biological sample to answer, quickly and easily, minimizing the risk of errors and reducing hands-on time. To that end, we recently announced collaborations with leading vendors of robotic platforms to provide automation solutions for customers requiring high throughput Sample Prep. A few weeks ago, we completed the acquisition of Advanced Liquid Logic or ALL. This acquisition will allow us to develop an automated and integrated solution for our low to mid throughput customers. A spinoff from Duke University, the company possesses foundational liquid handling IP, including approximately 100 issued or licensed patents and approximately 200 pending applications. ALL has developed a proprietary digital microfluidics technology, which enables the precise manipulation of small droplets within a sealed cartridge, eliminating the pumps, valves and tubes often associated with automated liquid handling. We believe this proven technology will enable us to deliver the simplest and most efficient sample-to-answer workflow, particularly for customers in the clinical and applied markets where these features are especially valued. I encourage you to visit ALL's website to see a video illustrating this exciting technology. As you know, part of our workflow strategy includes BaseSpace, an integrated cloud ecosystem. In Q2, we announced exciting new e-commerce functionality which provides software developers the infrastructure to charge for use of their applications. Customers now have access to tools, which will simplify data analysis, while providing a new and largely untapped opportunity for software developers. Several new applications are now available for purchase in the BaseSpace App Store and we expect more to launch in the coming quarters. Turning now to sequencing instruments, Q2 sequencing instrument revenue grew 37% compared to the second quarter of 2012, as a result of a strong demand for HiSeq instruments and 2,500 upgrades. The demand for HiSeqs was generated almost equally from existing capacity-constrained customers and customers new to the platform. This quarter, more than 75% of HiSeq orders were for the 2500 family, reinforcing the tremendous value of rapid run mode. The importance of the rapid run technology was recently demonstrated by Stephen Kingsmore and his associates at Children's Mercy Hospital in Kansas City. Using rapid run in a research and development configuration and a modified version of our aligner and variant calling software, they were able to prepare full genome sequence and correctly call potential disease-causing variants from a blinded quantified DNA sample in under 24 hours. Translational, commercial and hospital customers are placing great value on the inherent flexibility of the 2500 platform. Close to 45% of HiSeq orders were from customers using the technology in the clinical development or commercial setting. This demand has also driven HiSeq 2500 upgrades. We have now completed more than 85% of the upgrades that have been ordered and expect a few remaining to be completed in the third quarter. Customer satisfaction with HiSeq 2500 instruments and upgrades continues to be high. Later in the second half, we will deliver additional value to customers with the launch of reagents, enabling sequencing runs of up to 300G in approximately 60 hours. Additionally, our development efforts on long read, phasing and ordered array technologies are progressing well, and we'll continue to deliver dramatic performance enhancements to our SBS chemistry. We will also introduce MiSeq functionality in the third quarter, which will enable throughput of approximately 15G per run. Interest in this product enhancement is high as customers look forward to continually improving instrument performance. Our competitive position in the bench top sequencing market remains strong as evidenced by stable ASPs despite the successful conclusion of our 15 for 15 program, which offered a discount on the instrument when bundled with the purchase of 15 consumable kits and competitor price concessions. As a result, in the second quarter, we again won more than 80% of head-to-head placements. We continue to see strong MiSeq adoption from translational and clinical customers, including customers switching from capillary systems. Again this quarter, more than 50% of MiSeqs were ordered by nonacademic customers including a multiunit order from HistoGenetics, a leader in HLA testing services. HistoGenetics selected the MiSeq platform as it has the simplest workflow, as well as the highest quality data output for implementation into their clear production facility. HLA typing is performed on more than 1 million samples annually worldwide and we're actively engaged with the community to demonstrate the benefits of next-generation sequencing to this important application. Recently, the MiSeqDx Cystic Fibrosis System, which includes the MiSeqDx instrument, our CF carrier screening assay and CF diagnostic assay, became the first NexGen system to have the CE Mark applied. Our carrier screening assay detects 162 functionally-verified, clinically relevant variance within the CFTR gene, the largest variant panel available today. Our diagnostic assay has been shown to have superior performance in challenging regions of the gene, including homopolymers, as well as large deletions and mutations. Both of these assays run with low sample input and can be completed in less than 2 days. Moving to FastTrack Services. In the second quarter, we shipped approximately 2,500 genomes compared to 750 genomes in the prior year period. While genomes shipped were lower sequentially, due primarily to the timing of project completions, we received more than 6,000 orders for whole genome sequencing services in the second quarter, a new record. We expect to process these orders over the coming quarters as the samples are received. Included in this number is the initial award with the VA Million Veteran Program, where we will be working with Personalis to sequencing genotype more than 1,000 veterans and 1,000 genomes for Inova, a not-for-profit health care system based in Northern Virginia. Recently, we launched our Phasing Analysis Service based on the Moleculo technology. This is the first commercial service available for customers wanting to phase human genomes. Early access customers have provided positive feedback and study designs have demonstrated the diverse range of applications supported by this service. In the coming quarters, we'll also launch kits for generating synthetic long reads and phasing of human data. The integration of Verinata continues to progress well, and we're pleased to announce that reimbursement coverage for the verifi test has been significantly enhanced in the second quarter. Today, coverage for the verifi prenatal test is expanded to approximately 170 million covered lives in the United States, plus with the agreement with Teva Pharmaceutical's 25,000 lives in Israel. Part of this expanded coverage was a result of Verinata entering into a national agreement with Blue Cross and Blue Shield to offer independent plans access to competitive pricing for the verifi prenatal test. Importantly, contracted lives, a more important metric, as it reflects contract decisions for specific tests, have also grown significantly. We recently received contracting decisions from United Healthcare and Aetna, as well as multiple other payers. Today, more than 60 million covered lives are contracted for the verifi test. As you will recall, a key goal of the acquisition of Verinata was to enable the overall growth of the NIPT market. The 2 main prongs of this strategy are to license Verinata's intellectual property and once we've completed the necessary data, to submit the verifi test for regulatory approvals. We believe an IVD test will significantly expand the global market and enable all test providers to be successful in this field. During the second quarter, we began dialogue with the FDA on the trial design necessary for an NIPT submission. While a clinical trial to support a PMA application is a multi-year process, we are pleased with our early FDA interactions and with our progress today. With respect to our existing customers in the NIPT market, we are broadly engaged in discussions but have nothing specific to report to you today. Overall, I'm extremely pleased with our Q2 and first half results. In the second quarter, we grew revenue year-over-year and sequentially following a strong Q1. Orders exceeded our internal plan and we made significant progress on many of our strategies for continued technology leadership and long-term growth. Each quarter, we're diversifying our revenue base by engaging with customers who were using nexgen sequencing for new applications, making it easier, more efficient and more economical for them to access this empowering technology. We remain dedicated to improving human health by unlocking the power of the genome and continue to believe we are uniquely positioned to capitalize on the enormous potential of the sequencing market. I'll now turn the call over to Marc who will provide a detailed overview of our second quarter results.