Jay T. Flatley
Analyst · JPMorgan
Thanks, Rebecca, and good afternoon, everyone. To begin today, I will provide an update on the state of our business and markets before turning to our commercial progress. Marc will then review our fourth quarter financial results and our guidance for fiscal 2013. Despite uncertainty around sequestration and the general macro environment, our business has continued to accelerate. Q4 shipments were strong across all geographies, and revenue grew 24% year-over-year to $309 million. Shipments to the Americas grew 20% year-over-year, and European shipments were up 26% over the same period. Shipments to Asia continue to be strong with year-over-year growth of 12%, including 30% growth in Greater China. While the NIH funding environment remains uncertain in light of a potential sequestration, our customers continue to display stable ordering patterns. We believe this is due in part to a larger percentage of NIH funds being granted to sequencing-based research. Additionally, the European and Asian funding environments remain stable, and Asia may even improve slightly in light of Japan's recent stimulus announcement. Despite these positive trends, we remain focused on diversifying our customer base. In fiscal 2012, approximately 30% of revenue came from nonacademic and nongovernment segments, and our goal is to increase this to approximately 50% of revenue over the next 5 years. We believe this is possible as we accelerate the penetration of our technology into applied markets including the clinical, translational, consumer, forensic and agricultural segments. I'd like to now turn to the specifics of the Q4 results. Total microarray revenue increased 4% year-over-year due to the impact of BlueGnome, while organic microarray revenue declined slightly. Order volume grew sequentially as a result of demand for the Infinium Omni arrays and significant interest in the recently launched Infinium HumanCore arrays. In the first 2.5 months since launch, we received orders for 325,000 samples of the HumanCore arrays, which we expect to begin shipping this quarter. As an illustration of the high activity level that remains in the array market, in Q4, we shipped over 1 million samples worth of arrays across all of our array-based product lines, including Infinium, GoldenGate and VeraCode. Turning now to our sequencing business. Total sequencing revenue grew 35% over the fourth quarter of 2011, driven by strong demand for consumables. In fact in the fourth quarter, sequencing consumables grew 56% year-over-year due to higher utilization per instrument, as well as growth in both the HiSeq and MiSeq install base. Our Sample Prep business continue to gain share in the quarter and contributed significantly to sequencing consumables growth. Nextera and Nextera XT Sample Prep kits had a particularly strong quarter, and the TruSeq demand was strong from translational and clinical customers. In addition, we are further expanding our portfolio with a launch of innovative Sample Prep solutions that streamline workflows and decrease turnaround times. In the first quarter, we expect to launch the Nextera Rapid Capture Exome Kit, which will enable the fastest exome enrichment workflow for use on both the HiSeq and the MiSeq platforms. These kits will make the workflow 70% faster than the current solution. We also plan to release TruSeq Targeted RNA kits this quarter, targeting the mid-plex real-time PCR market, which we estimate to be a $300 million market today. Finally, I'm pleased to announce that we begun shipping our TruSeq DNA PCR-Free Kit, which provides industry-leading genome coverage, high accuracy in identifying variants and the ability to sequence challenging regions of the genome. We also continued to deliver dramatic enhancements to our SBS chemistry. Our latest technology innovations demonstrate the scalability of SBS by enhancing cluster density and read lengths. Our novel ordered array technology overcomes typical statistical limits to significantly increase cluster density and the number of reads per flow cell. This breakthrough development will increase sequencing output, enhance counting applications and reduce turnaround time through more efficient image processing. We expect to begin field testing this technology in Q3 and have it incorporated in our first kits around year end. We also recently announced the acquisition of Moleculo, which gives us access to a proprietary technology for assembling phased reads of more than 10 Kb at an extremely low error rate of Q50 or better. Through Sample Prep and bioinformatics, researchers can create a completely phased genome in 4 days with only 30G of incremental sequencing. This will directly benefit approximately 10% of the NGS applications today, as well as a portion of the capillary market. We plan to launch this in our services business during the second quarter, with kits available toward the end of the year. We will further expand the capability of the HiSeq platform in the second half of this year with the launch of new kits to sequence up to 300G in approximately 60 hours. This expanded capability will come solely from enhancements to reagents and software. Sequencing instrument revenue increased 6% compared to the fourth quarter of 2011, with MiSeq instrument sales demonstrating significant growth year-over-year. Additionally, ASPs remain strong despite the ongoing success of our trade-in program. Interest in the MiSeq platform also widened since we laid out the updated product roadmap at ASHG, including a path to 15G of output. Based on field commentary, our competitive position has strengthened, and we're optimistic that strong ordering patterns will persist. During the fourth quarter, we received more than 300 MiSeq orders, which exceeded our manufacturing capacity. This strong order trend, along with MiSeq winning head -- 80% to 90% of the head-to-head competitions, provides evidence that we have more than 50% market share this quarter. Customers are choosing MiSeq as it consistently delivers higher output and better data quality along with the easiest workflow. We believe this end-to-end workflow, including back-end informatics, streamlined data analysis and data sharing features via BaseSpace, offer the most comprehensive solution for desktop sequencing customers. The successful launch of the HiSeq 2500 in October illustrates the tremendous value customers find in the HiSeq platform. We now expect to upgrade around 35% of the existing HiSeq installed base. It will take us most of 2013 to complete this upgrade program as less than 10% of the installed base was upgraded during the fourth quarter. The HiSeq platform is now also enabled to stream data to BaseSpace. The breadth of analysis and functionality being delivered by BaseSpace apps is growing every month, and we expect a full e-commerce rollout in the second quarter. Our FastTrack Services business shipped more than 2,500 genomes in the fourth quarter or close to 3x the number shipped in Q4 of last year. Demand grew consistently through 2012, and in total, the Illumina Genome Network received orders for approximately 13,000 genomes. Today, interest in sequencing services remains high, including preliminary talks of large hospitals and governments that hope to sequence significant numbers of individuals. To fill the demand for sequencing services, we've added significant new capacity to our San Diego facility and will open a new lab later this quarter in our Hayward location. This facility, along with improvements to our existing infrastructure, will provide the capacity to sequence approximately 30,000 genomes this year. Moving on to our clinical business. We recently signed a definitive agreement to acquire Verinata Health, a leading provider of non-invasive prenatal test or NIPT, for the early identification of fetal chromosomal abnormalities. This acquisition will build on our earlier acquisition of BlueGnome, adding another building block to our portfolio and moving us toward our goal of leading the genetic revolution in reproductive health. These acquisitions, combined with our internal carrier screening and cytogenetics programs, provide us with a solid foundation to accomplish this goal. With this acquisition, Illumina is uniquely positioned to enable the growth of the NIPT market. We believe Verinata possesses foundational IP and has the most compressive non-invasive prenatal test. Our strategy will be to leverage these strengths by licensing Verinata's intellectual property, and once we compile the necessary data, submitting the 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. Verinata has signed an exclusive U.S. distribution agreement with PerkinElmer to drive adoption of the verifi prenatal test. We're excited about this announcement and look forward to participating in this partnership once our acquisition of Verinata has closed. I'm pleased to report that we also submitted our first 2 sequencing products to the FDA for 510(k) clearance in the fourth quarter: the MiSeqDx system and the cystic fibrosis full gene sequencing assay. We believe the CF assay is differentiated from current test offerings as it will sequence the entire CF gene while also identifying a group of specific CF areas. We're pleased with our execution in 2012 and our outlook for revenue growth in 2013 and beyond. To ensure this momentum translates into strong long term revenue growth, we will continue to make incremental investments in our core business in addition to investing in Verinata and BlueGnome. We have focused 2013 organic investments in 3 key areas. First, while the competitive dynamics surrounding our sequencing platforms are strong, today we're not able to match the geographic reach of our competitors. To improve this position, we plan to add more than 50 additional sales reps over the course of the year. This investment will add to growth in the near term and create significant leverage in the years beyond. We also plan to invest incrementally more in research and development this year due to the richness of our portfolio opportunities. Our goal is to remain in the leading edge of technology by introducing even a greater number of new products, investigating new chemistries including nanopore and working to provide solutions to customer bioinformatic challenges. Lastly, we're investing in the necessary infrastructure enhancements to support a $2 billion company. We recently began 2 new projects that are projected to cost approximately $10 million in 2013. The first multiyear project, being led by Marc Stapley, is focused on improving our global business processes via enhancements to our ERP system, as well as the related systems and processes necessary to support our growth projections. Christian Henry is leading a second project, which is focused specifically on manufacturing, planning and inventory management. Success of these programs will improve our order fulfillment performance and ultimately our gross margins as we more efficiently meet customer requirements. Part of this infrastructure build will be particularly focused on diagnostic and clinical customers. While nascent today, the clinical adoption of NGS is set to revolutionize health care. To this point, a number of organizations have recently published guidelines on the use of NGS in the clinic, including the American College of Medical Genetics and Genomics, the Association for Molecular Pathology and the CDC. These groups have cited the increased rate of clinical adoption of NGS as the catalyst for guidelines in an effort to ensure patients have access to high-quality data and interpretation. We believe that by making these strategic investments, we will accelerate the adoption of sequencing technologies more broadly into all of our end markets and position ourselves for strong long term revenue growth. I'll now turn the call over to Marc who will provide a detailed overview of the fourth quarter results.