Jay T. Flatley
Analyst · JPMorgan
Thanks, Rebecca, and good afternoon, everyone. Q1 was an extraordinary quarter for Illumina. Our business continued to accelerate, delivering orders substantially above our plan, with strong underlying trends across all geographies. Revenue grew 21% year-over-year to $331 million, which was not only the sixth quarter of sequential growth, but also a record for quarterly revenue. Total micro-array revenue increased 1% year-over-year, due to a combination of BlueGnome, strong instrument shipments and a robust quarter in genotyping services. Additionally, we saw a sequential increase in both sample volume and orders. Our outlook for arrays is generally as expected, with customer interest remaining high in our standard micro-array products, including Infinium OmniExpress Exome, Core Exome and the Omni2.5 products. In fact, we set a record for whole genome association, with approximately 300,000 samples shipped in the quarter. Additionally, our iSelect genotyping products are doing well across many customer types, including consumer customers. Our consumer array business appears to have hit a pricing sweet spot, leading to significant market elasticity. This resulted in a large order during the quarter, which is deliverable over several years. Turning to our sequencing business. Total sequencing revenue grew 32% year-over-year to more than $235 million. This substantial growth was a result of increased demand for consumables, sequencing services and HiSeq instruments. In fact, during the first quarter, sequencing consumables grew more than 40% compared to Q1 of last year, as a result of our larger install base, higher utilization per instrument and share gains in our Sample Prep business. Our Sample Prep kits continue to demonstrate robust year-over-year growth, as more customers switch from competitor's products or homebrew. Our Nextera kits drove a significant portion of the growth, along with demand from TruSight kits from commercial customers. New product introductions, specifically the Nextera Rapid Capture Exome Kit, which enables the fastest exome enrichment workflow, have been positively received. Since launched in Q1, a large genome center has switched from a competitor's exome enrichment platform to our new exome kit and many other customers are beginning to adopt this accelerated workflow. Shipments of our TruSeq targeted RNA kits will begin this month. These kits offer highly customizable gene expression profiling and will serve as a technology alternative in the mid-plex realtime PCR market, which we estimate to be approximately $300 million in size. The sequencing instrument revenue increased 7% compared to the first quarter of 2012, as we saw a resurgence in HiSeq instrument sales, including unit shipment levels above those seen in the fourth quarter of 2011. We attribute this demand to acquisition of new customers, as well as capacity constraints in our install base. In the first quarter, more than 40% of HiSeq shipments were to first-time HiSeq users including a large order from a Japanese pharmaceutical company and the Tohoku Genome Center. Additionally, capacity constraints are being felt by academic and translational customers given the increasing demand for sequencing, as the cost per data point comes down. We're committed to accelerating the adoption of sequencing through continued improvements to our SBS chemistry. One example of this is the recently announced product roadmap for the HiSeq 2500, which will provide the ability to sequence up to 300 g in approximately 60 hours. We remain on track to launch this reagent and software enhancement in the second half of 2013. Importantly, this product enhancement does not take advantage of our recently announced ordered array technology, which will further improve system performance, as we deploy it in particular kits. Demand for HiSeq 2500 upgrades is further evidence of the value proposition we're providing to our customers. Approximately, 20% of the installed base has now been upgraded and feedback continues to be very positive, siting improved accuracy and queue flexibility. We expect to ultimately upgrade around 35% of the existing HiSeq install base by year end. As expected, MiSeq orders were modestly lower sequentially, given the particularly strong Q4 results, but normalizing for the exceptional Q4. This quarter, MiSeq orders continued to demonstrate the steady quarterly growth that we've become accustomed to in the first 3 quarters of 2012. MiSeq ASPs were stable, compared to the prior quarter, despite the new 15 for 15 program, which offers a discount on the instrument when bundled with the purchase of 15 consumable kits. This program is intended to help our customers initiate their sequencing projects more quickly. Interest in the MiSeq platform remains high and our competitive position is incredibly strong. Feedback from our sales force points to stable competitive dynamics, with MiSeq still winning over 80% of head-to-head competitions. Increased adoption is being seen for applications outside of core research, including a multiunit ordering in Q1 from the U.K.'s Health Protection Agency, which is now part of Public Health England. We're focused on expanding our commercial reach this year, with 50 additional sales reps, which we're in the early stages of hiring. With this investment and our strong competitive position, we're confident in our ability to broaden our geographic reach, while building awareness in peripheral markets like microbiology and food safety. Today, both our MiSeq and HiSeq platforms are enabled to stream data to BaseSpace. More than 30,000 sequencing runs have been submitted by customers to BaseSpace, providing us with an invaluable resource to assess realtime instrument and reagent performance. Today, we have approximately 6,000 registered users and many researchers are sharing data across their research centers, a capability that greatly enhances the customer experience. The next major update to BaseSpace will roll out in Q2 and include an e-commerce capability, allowing the purchase of apps in our BaseSpace store. Given the rapid adoption of BaseSpace and positive feedback on this groundbreaking cloud solution, we believe we're building a foundation for a powerful committee of collaboration for life science researchers and eventually clinicians. Our FastTrack Services business achieved record shipments in the first quarter. We shipped more than 4,000 genomes, a 60% sequential increase, and also recognized a significant milestone by surpassing our 10,000th genome shipped. We continue to gain momentum in sequencing services. We're pleased to be the sequencing subcontractor on the initial award for the VA Million Veteran Program, where we will be working with Personalis to sequence and genotype more than 1,000 veterans. The fundamentals of this business are strong and we're in discussions on a number of large population-based studies, but we would like to remind everyone that service revenue can fluctuate significantly based on the timing of project completions. Importantly, part of this momentum is coming from shorter turnaround times for our FastTrack Services and in this quarter, we completed a project of more than 1,000 genomes in just 12 weeks. We recently added 2 new partners to the Illumina Genome Network: the Peking University Nova Gene in Beijing, China; and the HudsonAlpha Institute in Alabama, which is already accepting customer projects. In our clinical business, we continue to see strong demand from nontraditional customers looking to employ NexGen sequencing technology and in Q1, close to half of the HiSeq orders were to commercial, clinical and translational customers. Sessions at recent conferences, including HEBT, ACMG and AACR, point to increasing evidence that rapid progress is being made to adopt NGS sequencing in clinical settings. Illumina remains the clinical partner of choice, given that only our instruments can accurately and efficiently sequence panels of genes, whole exomes or whole genomes, flexibility customers are seeking in the clinical market. At AACR, we announced the release of our TruSight Tumor content sets and already have seen a number of customers, including Clarient and Ambry Genetics, adopt the panel for use in sematic variation, detection in tumors. We remain incredibly passionate about accelerating the adoption of NexGen sequencing in the clinic. We continue to push forward on our reproductive health strategy. Our MiSeqDx system and cystic fibrosis full gene sequencing assay submissions are currently being reviewed by the FDA. During the first quarter, we also submitted our Infinium Dx CytoSNP-12 assay and iScan Dx array scanner for 510(k) clearance. These products are intended to be used as an aid in the postnatal diagnosis of autism spectrum disorders, developmental delay and intellectual disability. Bolstering our efforts in carrier screening and cytogenetics are products from our acquisitions of BlueGnome and Verinata Health, which specializes in preimplantation screening for in vitro fertilization and prenatal testing, respectively. Through internal development and acquisitions, we now possess a broad portfolio of diagnostic platforms and methods, a solid foundation to accomplish our goal of leading the genetic revolution in reproductive health. The acquisition of Verinata closed in late February and we're pleased with the initial integration progress. While it's very early in the life cycle of the verify test, we're seeing significant growth in demand, assisted in part by our distribution partnership with PerkinElmer. Today, we're not prepared to share with you the run rate of testing, but are pleased that volumes have met or even slightly exceeded our expectations. Last week, Verinata announced that the verifi test is now available to Aetna members. This announcement, which was aided by the relationship between PerkinElmer and Aetna, makes the verifi test assessable to Aetna's approximately 20 million covered lives. Additionally, through our distribution agreement with PerkinElmer, we're in active discussions with other payers to expand verifi coverage. In future quarters, we hope to share with you our strategy for working with the FDA to bring the market in IVD, noninvasive prenatal test and also our plans for working with other NIPT customers. We're in the early stages of developing our IVD application approach, including the level of data required and timelines for submitting the test for regulatory approval. We believe an IVD test will significantly expand the global market and enable all test providers to be successful in this field. We've also completed an in-depth study of alternative scenarios for working with our existing NIPT customers and are in the process of executing on that strategy. This is inherently delicate, will take some time to implement and, of course, may take a number of different paths, but we believe that our strategy remains sound and actual. Before closing, a quick update on funding. The effects of the sequester on future buying patterns of our customers remains to be determined, but to date, we've not been impacted and our business remains robust. We continue to see significant interest in our platforms and ordering patterns from our academic and government customers are stable. Several factors lead us to believe that this trend will likely continue. First, a number of NIH centers, including NHGRI, have been conservatively funding grants at 90% under the continuing resolution. Second, NIH funding to sequencing base grants has also increased at a double-digit CAGR over the last few years, including a 4-year high for new sequencing-based grants in 2012. Lastly, outside of the U.S., funding is steady, if not improving. In Europe, funding is expected to be stable, with a Horizon 2020 budget and Asian funding is improving modestly, as evidenced by the Japanese stimulus. Overall, Q1 was an exceptional start to the year. We grew revenue year-over-year and sequentially, despite a strong Q4 and a historically soft Q1. Our order rates remained strong and our long-term strategies for continued technology leadership are driving forward. We remain dedicated to improving human health by unlocking the power of the genome and enabling our customers across multiple markets to do this ever more efficiently and economically. The sequencing market has enormous potential and we're uniquely positioned to capitalize on these opportunities. I'll now turn the call over to Marc, who'll provide a detailed review of our first quarter results.