Jay Flatley
Analyst · JP Morgan
Good morning, everyone, and thank you for joining us today. During the third quarter, we experienced a confluence of factors that led to our very disappointing results. I'll describe what we know with regard to each of these factors and also try to be clear on what we do not know. First, the global funding environment for academic research is highly uncertain, as governments in the U.S. and Europe focus on reducing fiscal deficits while at the same time confronting slower economic growth. In 2011, the U.S. NIH budget was down 1% compared to 2010, and the proposed budget for 2012 ranges from down 0.6% to up 3.3%. And it's currently operating under a continuing resolution that is down 1.5% through November 18. In addition, the stimulus funding that peaked about a year ago is rolling off, creating an additional headwind versus the aggregate NIH funding levels of 2010. We have not believed that alone the stimulus roll-off would have been a significant influence on our business. However, in conjunction with the decreasing baseline of NIH funding, it is a material factor. To remind you, we estimate that approximately 1/3 of our total revenue is derived from NIH funding. And while these specific budget reductions are a concern, an equivalent concern of our customers stems from the ongoing uncertainty of what the future funding scenario will provide. In that regard, the 12-member Super Committee formed under the Budget Control Act is presumably working responsibly to identify $1.2 trillion of budget reductions over the next 10 years, beginning in 2013 and to have this agreed before Christmas. Failure to agree could result in an 8% across-the-board sequestration, including the NIH. We believe that while the potential exists for NIH to be cut by as much as 8% in 2013, this is an unlikely scenario. Research funding is looked upon favorably by both parties and by the White House. In addition, while the overall Health and Human Services' budget, of which NIH is a part, may be cut under the BCA process, we believe HHS has the ability to reallocate within its budget to spare NIH from the full 8% impact. We also remind investors that after 2013 discretionary spending for the next 8-year period is set to increase yearly by 2% or more. Parts of Europe are also seeing research funding discontinuities. While certain countries like the U.K. or Germany have experienced stable or even increased funding, other geographies, such as Southern Europe, have seen cuts or funding delays. Europe, while typically slow in the summer, came in much weaker than expected in Q3 with limited visibility to improvement. So what we know is that in the U.S., the combination of a reduced 2011 NIH budget, the potential 1% reduction to NCI and the NHGRI for 2012, the recent 20% reduction to select genome centers for 2012, the roll-off of stimulus, the 1-year no penalty extension of error grants, and the uncertainty regarding future budgets were in combination a major impact on our incoming order rate. What cannot be determined at this point is the relative contribution of these factors or how the 2012 or 2013 NIH budgets will ultimately resolve. We have no more information on those prospects than any of you have. Overall, we continue to believe that funding allocations globally are increasingly favoring genetic analysis tools and in particular, next-generation sequencing. The second major issue during the quarter has been our customers' adjustment to the improved sequencing throughput of our V3 consumable kit, which has resulted in a two- to threefold increase in capacity. Sample delays and new sample availability to utilize this improved capacity contributed to a decrease in HiSeq placements and slower-than-anticipated upgrades of GAs. We also believe these factors resulted in fewer sequencing runs as certain customers either waited for samples to consume capacity, adopted indexing workflow changes to fill the runs or finish projects earlier than expected. We believe this excess capacity is temporary and will be fully absorbed by the market over the next few quarters. These 2 issues, funding and our V3 kit upgrade, were the key contributors to an unprecedented slowdown on purchasing during our historically strongest quarter. We did not see the historical pattern of large orders at the end of September when the government fiscal year ends. Concerns around research funding, which were felt broadly, particularly among our large volume centers, precipitated shipment delays. All indications are that the shortfall was not due to competitive pressures and in fact, our market share is stronger in our core markets than it's ever been. I'd like to turn now to the specific results of the quarter. Our total revenue in the quarter was down 1% over Q3 of last year. Our overall business was below forecast for the aforementioned reasons. Europe in particular experienced a greater relative decline compared to forecast in Asia-Pacific or the Americas. While both our microarray and sequencing businesses were below forecast, funding uncertainty appeared to affect our sequencing business to a greater degree. Despite our results, we gained market share and built backlog in the quarter. Total Q3 microarray revenue is down 9% year-over-year, driven in large part by the tough comparison from the very successful launch of our Omni2.5Quad in the year-ago quarter. We did however ship a record number of focused content microarray samples during the quarter. Microarray instrumentation, while down sequentially, grew year-over-year due to shipments of HiScan and HiScanSQ systems. We recently announced several new microarrays offering novel human exome content, developed in close collaboration with leading researchers which will ship in Q4. Infinium HumanExome, OmniExpressExome and Omni5Exome BeadChips allow researchers to economically and rapidly interrogate samples with markers for over 250,000 exome variance with the ability to add additional custom markers. Researchers are now able to study very rare coding variants in dramatically larger numbers of samples in a more rapid fashion than would be practical by sequencing. Orders for the exome arrays were the leading category of array orders in Q3 but were not available for shipment during that quarter. Looking at our sequencing business. Total sequencing revenue grew 5% over a year ago, largely attributable to the broad adoption of the HiSeq 2000. As we experienced in Q2, over 90% of HiSeq orders in Q3 were to customers outside major genome centers. We also added approximately 25 new HiSeq sequencing customers during the quarter, which is consistent with our historical run rate. Adversely affecting sequencing instrumentation revenue was the significant decrease in upgrades of Genome Analyzers to HiSeqs as well as the challenging funding environment and the release of our V3 kits as previously discussed. Total sequencing consumable revenue grew by more than 40% compared to Q3 of last year. As mentioned in our pre-release, however, we noted a large sequential drop in sequencing consumables on the GAs, resulting primarily from a lack of utilization of these instruments in sites that also have HiSeqs. Sequencing is so much cheaper on a HiSeq that the GAs will not be used unless the HiSeqs are running at capacity. We believe the HiSeq consumable pull-through was also affected by sample delays, new sample availability and funding uncertainty. Turning to our recently launched MiSeq system. There was tremendous interest from customers at the recent ASHG meeting. Customers are excited by the breadth of application, ease of use, accuracy, rapid turnaround time and throughput. We've been very pleased with orders from MiSeq and shipped over 45 systems in Q3. We expect to ship in volume during Q4 and to carry a significant backlog of instruments for the next few quarters as we scale manufacturing to meet demand. At ASHG, we announced 3 new and exciting workflow enhancements from MiSeq. BaseSpace, a cloud initiative, removes a significant barrier for adoption of next-gen sequencing and should accelerate the migration of sequencing from capillary electrophoresis to our next-gen platforms. Data generated by MiSeq is automatically pushed to the cloud, making it simple to use, secure, reliable and seamless for collaboration. In addition, the new Nextera DNA Sample Prep Kits allow for the fastest and simplest sample prep today. These kits now support 2x150 base paired reads, sample indexing up to 96, improve reagents optimized for PCR and reduce error rates. Finally, TruSeq Custom Amplicon Kits from MiSeq offers scalable multiplexed assay for rapid, cost-effective custom variant identification. Researchers can now accomplish projects in several days that previously took several weeks or months. During the quarter, we announced our collaboration with the University of Oxford to sequence 500 individuals afflicted with cancer or life-threatening immunological or rare Mendelian diseases. We believe this collaboration will demonstrate the enormous value next-generation sequencing holds for clinical research, as it empowers clinicians and geneticists to evaluate the genetic basis of disease with a previously unmatched level of precision. This is the next step towards a new healthcare paradigm in which genetic information from NGS is likely to become much more widely used in routine medical practice. Our Illumina Genome Network continues to gain traction as we received several large orders during the quarter, including over 500 genomes from Stanford University and 450 genomes from a large biotech company. As a reminder, we established IGN to provide whole human genome sequencing services through Illumina and select partners using our Illumina technology. In fact, today, we're pleased to announce that the British Columbia Cancer Agency, BCCA, has become the latest IGN partner. Although our revenue for the quarter did not meet our forecast, our operational execution was excellent. In particular, we were able to successfully complete the development of the MiSeq system on schedule with a level of manufacturing robustness that is higher than any system we've ever launched. During the quarter, we reduced our inventory balances as our supply chain and production groups were able to quickly react to reduced levels of demand. We also achieved ISO 13485 certification in our Hayward manufacturing facility, which will pave the way for us to achieve FDA certification for our sequencing instruments. Finally, we qualified our Singapore operations to produce sequencing consumables and expect to produce about 50% of those products out of our Singapore facility, driving our future tax rate down. Given the revenue challenges we saw in Q3, we've developed a plan to restructure our business and will begin the implementation of that program shortly. As Christian mentioned, we expect to incur a restructuring charge of approximately $15 million to $17 million, the majority of which will be recorded during the fourth quarter of 2011. Despite of our revenue shortfall, we increased our gross margins year-over-year and believe this trend should continue. We also built our backlog during the quarter. Our tax rate decreased sequentially, primarily from the mix of earnings shifting to lower tax jurisdictions, and we expect to realize more significant tax savings beginning in 2012 and beyond. Certain end markets, like ag, continued to show strength as illustrated by a record number of focused content samples that were shipped last quarter. HiSeq consumables continue to grow in the U.S. and the recently launched Omni2.5 Octa was our best-selling array in Q3. Interest in MiSeq and our exome arrays is also extremely high. Illumina's history has been marked by our ability to innovate and rapidly bring exciting new technologies to the market. Despite the impact of the V3 kit, driving down the price of sequencing genomes will ultimately result in a significantly larger market for our products. Our future growth will be fueled by our ability to continue the historic pattern of innovation and rapid market introduction. Over the next few years, sequencing will become widely adopted in clinical applications as evidenced by Sequenom's recent launch of their MaterniT21 test. Our development pipeline remains strong on the heels of some exciting product launches, including MiSeq, our exome arrays, Bovine LD, TruSeq Custom Amplicon and BaseSpace. The fundamentals of our business and our markets remain intact. We believe our market share is as strong as ever as is our order win rate. Next-generation sequencing influences healthcare delivery as genetic information becomes more widely used in routine medical practice. While we were very disappointed by our revenue performance in Q3, we generated cash flow from operations of $90 million and are taking steps to optimize our cost structure to maintain strong profitability. Thank you for your time, and we'll now open the lines for questions.