Jay T. Flatley
Analyst · Cowen and Company
Thanks, Marc. To begin, I'd like to discuss several key results from the fourth quarter. Overall, we were pleased with our results in Q4 despite spending almost the entire quarter under a continuing resolution, which funded the NIH down 1.5% versus 2011. While it's hard to be certain that Q3 2011 was the bottom, many of the issues that we saw in Q3 have improved. While the global funding environment remains uncertain and peak stimulus continues to roll off, the adjusted 2012 NIH budget is now known and has increased 1% versus 2011. While we understand that the potential exists for NIH funding to be cut by as much as 8% in 2013, we believe that such a profound reduction in NIH funding is an unlikely scenario. Turning now to another challenge we faced in Q3, our customers' adjustment to the sequencing throughput of our V3 consumable kit, that has also improved. Utilization of HiSeqs increased slightly to $273,000 in Q4, but we see several reasons to be encouraged. We're implementing a price increase in late Q1, HiSeq utilization trends have increased in Europe and Asia-Pacific, sequencing consumable orders grew 60% sequentially in Q4 and we expect our new TruSeq exome enrichment pricing to directly improve utilization. We believe sample acquisition logistics continued to improve as well, indexing workflow changes are becoming more routine and researchers' library generation has been scaled to meet the throughput of our V3 kits. Anecdotally, Q4 felt like customers were getting back to work. I'd like to now turn to some specific results from the quarter. Q4 was a record for array orders. Both genome, custom and focused array orders all grew sequentially, with customer array orders growing over 50% sequentially and genotyping arrays up 60% sequentially. Two large consumer orders were placed in Q4 as well, including one from ancestry.com for approximately $7 million. Turning to our sequencing business. Total sequencing revenue in Q4 grew slightly over a year ago, attributable to increasing sequencing consumables and the first-quarter of volume shipments of MiSeq. As we experienced in previous quarters, approximately 90% of HiSeq orders and shipments in Q4 were to customers outside the major genome centers. Total sequencing consumable revenue grew over 30% compared to Q4 of last year. Both HiSeq and GA pull-through increased sequentially. We're pleased that HiSeq consumable orders in Q4 totaled more than in all of fiscal year 2010. In our services business, we had a record revenue quarter and shipped 900 complete human genomes, our largest number to-date. In Q2, we expect to announce premium services products using the fast turnaround capability of the HiSeq 2500, coupled with enhanced sample prep and new informatics software. I'd like to now pick up the presentation on Slide 12. With the addition of the HiSeq 2500 and 1500, we now have 7 instruments in our sequencing portfolio that stand the full range of market requirements. Our flagship product is the HiSeq 2500, offering the lowest cost per base and multiple sequencing modes. The HiSeq 1500 is the single-flow cell, lower throughput, lower-priced version of the 2500. The HiScanSQ is the world's only system that can both sequence and can scan microarrays. MiSeq, our desktop entry, has had a very successful launch and is well-positioned to penetrate the diagnostics market, as well as to address the needs of our existing Illumina customers. One key aspect of this product line, of course, is that all these systems run on the same proprietary SBS chemistry, which gives us enormous leverage when we launch new platforms into the market. In 2012, we will further enhance MiSeq to expand its breadth of performance and applications. We will provide less expensive and lower output kits to run applications that don't require the full capability of the current MiSeq. At the same time, we're also increasing the throughput of MiSeq by about a factor of 3, increasing the read lengths to 2x250 bases and reducing cycle times yet again. The new version of MiSeq can achieve up to 7 billion bases per run, and is ideally suited for running deep coverage, targeted cancer panels. Enhanced MiSeq will be commercially available in the middle of 2012, and our current install base is upgradable with a simple no charge enhancement to the instrument. We've been in active discussions with over 70 clinical partners interested in using the MiSeq for diagnostic applications. Approximately 50% of orders for MiSeq are from clinical or commercial customers, unlike the high predominance of academic customers buying HiSeqs. We expect to submit the MiSeq platform to the FDA for 510(k) approval before year-end. At the top end of the product line, the HiSeq platform has been extremely well adopted into the clinical market and has, in fact, truly created a new market for high throughput clinical tests. In high throughput applications, HiSeq is an ideal instrument because it has the ability to tackle sequencing problems that require high depth to detect rare events or to multiplex very large numbers of samples. We doubled our placements into the clinical market in 2011 versus 2010. We show on this slide a sampling of organizations working on clinical HiSeq assays, particularly for applications that require large sample numbers. In the sequencing market, our customers are increasingly focused on speed of result. The HiSeq 2500 is a new product we announced last month, with a throughput of a HiSeq 2000 but also capable of sequencing a full human genome in a day. We've accelerated the imaging, improved cycle times and reduced the imaging area. Cluster generation is automated and done onboard the instrument, ideal in a clinical setting. This technology uses a special flow cell and reagents, and has achieved quality better than or equal to what we get with a 600G run. In the genome-in-a-day mode, the HiSeq 2500 is capable of running up to 20 exomes in a day or up to 30 RNA seq samples in 5 hours. We expect to deploy this technology in our services business this month. In Q2, we expect to announce some premium products in our services business that use the speed of the 2500 to do a genome in a day and couple it with enhanced sample prep and informatics to reduce the overall cycle time to result. This capability will become very critical for applications such as clinical sequencing. The instrument itself will become available as the HiSeq 2500 in the second half of the year. The HiSeq 2000 will be sealed upgradable for a cost of $50,000. Next-generation sequencing is a core technology for any researcher doing modern life science research. We've seen over the last month a number of important announcements that demonstrate the continued potential for very large investments in high throughput sequencing. In Connecticut, $200 million was allocated for Jackson Labs; in the U.K., over $500 million of funding for biomedical research. The New York Genome Center, a consortium of 11 academic institutions, was funded at about $125 million. And in Canada, grants for $67 million of next gen sequencing. And recently, a very exciting announcement from the Farroe Islands, the first country to announce that they intend to sequence their entire population of 50,000 people. We're now working with them to make that program a reality. Over the next few years, we believe there will be some very large new sequencing markets emerging. If you assume $1,000 genome with a 1% penetration, the clinical trials market would be an incremental $24 million in annual revenue. The cancer market about $250 million and a newborn screening about $350 million in incremental revenue. In total, over $600 million in emerging market opportunities at a 1% penetration. We think many of these markets are going to grow to 10% quite quickly, particularly Markets like cancer where we think in the next few years, it would be almost irresponsible for a physician treating a cancer patient to not have that tumor sequenced. We have a rich and deep R&D pipeline, and here's a glimpse of what we think are some of the key technical and market developments coming over the next few years. There are going to be many more sample types that become available for sequencing as the technology improves, including paraffin-embedded samples. There are approximately 100 million of these tissues, particularly cancer tumors embedded in paraffin, that will become accessible with new sample prep technology that we will bring to market. Circulating tumor cells to detect diseases early in blood will become a large market. And we're pushing the sequencing now down to the range where we will, in the next year or 2, be able to robustly sequence single cells. This will begin to give the ability to examine the heterogeneity of cancer tumors, the next frontier in cancer tumor analysis. From a systems performance perspective, we continue to make major improvements in as many degrees of freedom. We will continue to make our clusters denser by at least a factor of 2, our cycle times can get much faster and we have a number of programs focused on long reads and long-range haplotyping. These advancements will open up new markets such as the ones we've talked about in clinical and forensics, cancer and newborn screening, and in the long run, the biggest market of all, which is the consumer market. Over the next few years, we will productize a number of new assays as well. We have not yet found the ultimate limit of our SBS chemistry, but at some point it probably will top out. So we're working on chemistry A that has cycle times potentially down as low as 10 seconds, very high accuracy and the ability to do long reads. This assay could work both with light-based and lightless detection systems, and have very low reagent costs. Chemistry A is sequencing today inside of Illumina. We're also working on another chemistry we call Chemistry B. This is a single molecule chemistry with very long reads and very fast runs, but we think with some fundamental advantages over the other single molecule chemistries that have been brought to market that suffer from very low accuracy. This would yield an extremely low-cost device and low-cost runs. In conclusion, we think we have a very exciting product line up for 2012. You'll see Illumina continue to innovate. We have a focus on strong operational execution to drive leverage in our income statement, while maintaining our technological lead. The clinical market is emerging very rapidly and will be a key story in 2012. The overall sequencing market potential is enormous, and Illumina has the technology, people and infrastructure to continue to lead this market. Our discussion this afternoon flows well into our next slide. Our reasons for rejecting Roche's unsolicited offer to acquire Illumina for $44.50 per share. We provided significant detail on our position in our press release and our 14D-9 today, but in short, our board, with assistance from independent financial and legal advisers, determined that Roche's offer dramatically undervalues Illumina and that it's not in the best interest of our shareholders. I'm sure you can tell we feel strongly about this. We think it's clear from our track record and market leadership that Illumina is singularly positioned to capitalize on tremendous market opportunities in the years ahead. Our industry is nascent, and we're on the verge of personalized medicine becoming a reality. Illumina has the promise and potential to experience extraordinary growth in the years ahead, as genetic information becomes broadly applied beyond molecular biology research and into molecular diagnostics, reproductive health and cancer management. We would also note that we have a solid track record of performance and execution, not just in this most recent quarter but also over many years. This record is rare in the industry and we believe will continue to create value for our stockholders. We've seen in the press that Roche has no plan B. We don't disagree with that statement, since there simply is no other company like Illumina. Despite the innovation, growth and shareholder value Illumina has delivered to-date, we've only scratched the surface of the market opportunity we see in genetic analysis and diagnostics. Our market position, technology platform and pipeline, management team and culture, make us uniquely positioned to execute on this remarkable opportunity. It's the board's responsibility to protect and pursue the path that has the highest probability of delivering the tremendous value that Illumina expects to continue to create for its shareholders. For all these reasons and more, our board has rejected Roche's grossly inadequate offer. Thank you for your time, and we'll now open the lines for questions.