Jay T. Flatley
Analyst · Tycho Peterson, JPMorgan
Thanks, Marc. As previously mentioned, we're very pleased with our third quarter results, particularly in light of the macro conditions in our markets. The positive trends, that began in the fourth quarter of 2011, continued through the first 3 quarters of 2012. Despite third quarter reagent utilization being somewhat impacted by summer vacations and the clearing of back orders in Q2, we saw sequential revenue and EPS growth with solid operating margins. This quarter saw the introduction of several new products and service solutions, many of them clinically focused, including the recently completed acquisition of BlueGnome. Sequestration aside, we now believe that the NIH funding is set for the next 6 months, given the continuing resolution that's been signed into law by President Obama. Additionally, the NIH recently stated that it will conservatively fund existing grant awards at 90% of the prior year's level for the next 6 months, given the uncertainty of the final budget. This is consistent with how the NIH has dealt with continuing resolutions in the last 5 years. As everyone is aware, it's unclear whether sequestration will actually take effect on January 2, and if so, for how long it will remain in place. Our outlook for European and Asian funding is unchanged. As consistent with our communication on the second quarter call, funding in these regions appears to be stable. We're seeing a diversification in our customer base, reducing our overall exposure to government funding. We've accomplished this by focusing on translational genomics in clinical segments and by increasing our penetration into applied markets. As a result, we believe that approximately 30% of our revenue today comes from non-academic and non-government segments. Going forward, we're committed to furthering this diversification through our focus on developing these markets. I'd like to now turn to the specific results of the quarter. Q3 shipments to the Americas were much improved over last year. We saw U.S. shipments increase 19% year-over-year, and Canadian shipments increase 11%. European shipments were up 19% over the same period, while shipments to Asia continued to be strong with growth of 21%, including 79% growth in China. In the array business, total microarray revenue declined 3% sequentially, primarily due to strong Infinium sample shipments in Q2. However, shipments for iScan microarray instruments in Q3 were the highest since the third quarter of 2010. We recently launched the Infinium HumanCore Arrays, which include the HumanCore, HumanCore Exome and HumanCore custom arrays. This family of products was developed in collaboration with several leading research institutions in an effort to provide a tool to perform large-scale, economical genotyping studies, with the option to customize content for a specific cohort or population. Turning now to our sequencing business. Total sequencing revenue in Q3 grew 4% sequentially, attributed primarily to growing instrument revenue and genome sequencing services. Total sequencing consumable revenue grew 44% compared to Q3 of last year. While HiSeq utilization was down sequentially, this was partially offset by strong growth in the HiSeq and MiSeq install base. TruSeq and Nextera sample prep revenue year-to-date has more than doubled as compared to the same period as last year, demonstrating the rapid uptake of Illumina sample prep kits within our customer base and the overall importance of complete end-to-end solutions for sequencing. Average annualized consumable utilization on HiSeq decreased to $315,000 in Q3 from $338,000 in Q2. It is up 17% year-over-year from $270,000 in Q3 2011. We expect quarterly variations and pull-through. Due to seasonality in the timing of purchasing cycles, we encourage investors to use a multi-quarter rolling average as a method to model pull-through trends. Consumable price increase announced in April will be almost entirely reflected in the pull-through for this coming fourth quarter. In Q4, we will also begin to see the impact of the rapid run mode of the HiSeq 2500, which yields greater revenue per genome, and we expect sample prep revenue to continue to grow. In September, we announced the TruSeq Stranded mRNA and total RNA sequencing sample prep kits. These kits enable gene expression studies that provide a complete view of the transcriptome even from low-quality RNA samples, such as formalin-fixed paraffin-embedded or FFPE samples. Total RNA kit leverages Epicentre's Ribo-Zero ribosomal RNA reduction chemistry, an example of how we're combining unique technologies from Epicentre with the core Illumina sequencing technology to provide complete solutions. These new kits have been received positively by customers, who praised the high data quality, workflow improvements and ability to analyze FFPE samples. This feedback, particularly in view of the ENCODE project which highlighted the enormous potential for RNA-Seq, enforces our excitement about the future potential of this application. Sequencing instrument revenue was up 16% sequentially, primarily due to increased HiSeq shipments. We continue to be delighted by the interest in our highest throughput instrument, the HiSeq 2500, both from new customers as well as core labs and research centers that are adding capacity. We're also excited about the rate of upgrade orders for the HiSeq 2000 install base. Based on orders booked to date, at least 30% of the install base of HiSeq 2000 and 1000 instruments will be upgraded exceeding our expectations. As a reminder, the $50,000 promotional upgrade price ended on October 1, and a price to upgrade is now $125,000. We do expect upgrade orders to continue but in a significantly slower pace. Through Early Access, HiSeq 2500s were shipped in Q3, and we are on track to commence full shipment of the product and upgrade in the next few weeks. This release will also include the ability of HiSeq to stream data to BaseSpace, our cloud computing solution. We continued to be pleased with the market penetration of MiSeq. MiSeq orders grew sequentially for the fourth consecutive quarter. Demand for this instrument is coming from across the globe, and we continue to see success with our trade-in programs. Despite launching our desktop sequencer platform 12 months later and at a higher price than the competition, we believe we have approximately 50% market share in the installed units and significantly higher share of the market revenue. More than half of the MiSeq orders continued to come from non-academic customers, the growing presence in the clinical and applied markets, as evidenced by the recently announced FDA selection of MiSeq for its foodborne pathogen identification program. This contract demonstrates the potential of the MiSeq to drive large multi-unit orders. MiSeq ASPs were down slightly in the quarter due to the continued success of our trade-in program. The average annualized pull-through per MiSeq was approximately $45,000. We remain focused on sales and marketing activities to drive continued growth in our share in this desktop market. Many MiSeq customers are experiencing up to 10G per run as a result of the upgrade we deployed this quarter. This no-charge upgrade is approximately 40% complete. Based on this performance, the breadth of enabled applications and MiSeq's ease of use we're very well positioned compared to the latest competitive entry in the desktop space, which is priced almost twice as high as MiSeq. Comparatively MiSeq, consistently generates more output and better data quality and has the easiest workflow. Combined with ease of storage, streamlined data analysis and data sharing features on BaseSpace, we believe we have the solution that best addresses the needs of the desktop market, including those customers with applied and clinical applications. Our FastTrack Services business had a very strong quarter. As Marc mentioned, we shipped more than twice as many samples in Q3 as we did in Q2 and achieved a new record for whole genome shipments. In addition, we continue to build our backlog, and ASPs for new orders significantly exceeds our expectations. In Q2, we announced the non-domestic release of our realtime PCR reagent portfolio, including a novel probe-based chemistry for gene expression analysis called NuPCR. We're pleased to report that we've now signed a major distribution agreement for our Eco instrument and NuPCR in the U.S., which we plan to announce in mid-November after we trained the distributor sales force and have the order processing systems fully in place. We've had some exciting development in our clinical business in the last several weeks, including the acquisition of BlueGnome. BlueGnome is a leader in the fields of cytogenetics and preimplantation genetic testing. It provides products for identifying genetic abnormalities associated with developmental delay, cancer and infertility. Its products include 24sure, a preimplantation genetic screening test for counting the chromosomes in a single human cell. This test is used by in vitro fertilization clinics and specialty testing labs around the world to increase the success rate of IVF while decreasing risks associated with multi-birth pregnancies. Clinical data have shown that PGS greatly improves IVF success, increasing pregnancy rates for women and reducing miscarriages. BlueGnome's portfolio also includes CytoChip, a powerful test for investigating genetic abnormalities associated with developmental delay or with complex leukemias. CytoChip is currently used by more than 200 labs across 40 countries as a first-line cytogenetic test, replacing traditional G-band karyotyping. BlueGnome is also well known for their solution-based approach to software design and assay workflows. Its BlueFuse software package is wrapped around their entire suite of cyto products and applications. The addition of BlueGnome as an Illumina company will enhance our presence in the cytogenetics market by allowing us to integrate our products into its software solution, while also providing a channel to IVF clinics. This acquisition is another building block toward our goal of leading the genomic based diagnostics market. In early September, we announced 2 other important steps along our clinical path. The first was the announcement of TruSight content sets, NGS panels that were developed in collaboration with recognized experts for specific genetic diseases or conditions such as autism, inherited cancer, cardiomyopathy, early childhood disease and rare disease. The second was an alliance with Partners HealthCare, integrating MiSeq functionality with their GeneInsight platform to streamline the analysis, interpretation and reporting of complex genetic test results. The combination of the content sets with new interpretation and reporting tools is a major step forward to further drive adoption in the clinic. We also remain on track to submit the MiSeq system to the FDA before year end. The individual genome sequencing service has continued to provide access to NGS, patients and their physicians the predominant focus on pediatric and cancer cases. We recently implemented the advances of the HiSeq 2500 into our CLIA services lab, enabling fast turnaround clinical whole-genome sequencing to be done in as little as 2 weeks. Our IGS service make it possible for healthcare practitioners to use data generated by whole-genome sequencing in the clinic, as the turnaround time is consistent with the demands of patient care. We believe that making our technology and platforms accessible, developing disease-specific content and creating robust interpretation and reporting solutions are key to the adoption of NGS in the clinic, and we continue to build on that understanding through deep collaboration with the communities driving this evolution. Yesterday, Illumina held an inaugural company-sponsored symposium called Understand Your Genome to explore best practices for deploying NGS in the clinical setting. This educational event brought together nearly 70 healthcare professionals, scientists, researchers, policymakers and consumers, including a Nobel laureate. During the event, these thought leaders explored laboratory and clinical considerations, implementing and deploying whole-genome sequencing in the mainstream clinical practice. Attendees who had their genome sequenced and annotated by Illumina's clinical geneticists were able to visualize their own genomic data on Illumina's MyGenome app for the iPad. We'll continue programs such as this to lay the groundwork for routine clinical use of whole-genome sequencing and to enable collaboration within the communities that will drive this transformation. In conclusion, we're very pleased with our execution this year and our outlook for the fourth quarter. We made tremendous progress with our market-leading instruments in both the high-throughput and desktop markets, and we're now field-upgrading both instruments to the latest specifications. We've announced a number of new products and collaborations and completed the acquisition of a remarkable business in the U.K. Our diagnostic story is starting to take shape, and we're extremely excited about the potential for NGS in the clinic. Thank you for your time, and we'll now open the lines for questions.