Operator
Operator
Hello, everyone, and welcome to the Third Quarter 2015 Illumina, Incorporations' Earnings Conference Call. At this time, all participants are in listen-only mode. We will facilitate a question-and-answer session towards the end of this call. As a reminder, this call is being recorded for quality, and replay purposes. I would now like to turn the call over to Rebecca Chambers, Vice President, Investor Relations and Treasury, Rebecca Chambers - Vice President-Investor Relations & Treasury: Thank you, Lauren, and good afternoon, everyone. Welcome to our earnings call for the third quarter of fiscal year 2015. During the call today, we will review the financial results released after the close of the market, and offer commentary on our commercial activity, after which we'll host a question-and-answer session. If you have not had a chance to review the earnings release, it can be found in the Investor Relations section of our website at illumina.com. Participating for Illumina today will be Jay Flatley, Chief Executive Officer; Francis deSouza, President; and Marc Stapley, Senior Vice President, and Chief Financial Officer. Jay will provide an update on the state of our markets, Francis will comment on product performance, and Marc will review our third quarter financial results as well as provide updated guidance for 2015. This call is being recorded, and the audio portion will be archived in the Investors section of our website. It is our intent that all forward-looking statements regarding our expected financial results and commercial activity made during today's call will be protected under the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to risks and uncertainties. Actual events or results may differ materially from those projected or discussed. All forward-looking statements are based upon current information available, and Illumina assumes no obligation to update these statements. To better understand the risks and uncertainties that could cause actual results to differ, we refer you to the documents that Illumina files with the Securities and Exchange Commission, including Illumina's most recent Forms 10-Q and 10-K. With that, I will now turn the call over to Jay. Jay T. Flatley - Chief Executive Officer & Director: Thanks, Rebecca, and good afternoon, everyone. As we reported a few weeks ago, third quarter revenue was approximately $550 million, an increase of 14% over the prior-year period, and our 16th consecutive quarter of sequential revenue growth. Despite missing revenue expectations by 3%, we witnessed strong underlying trends in many parts of the business, including total sequencing revenue growth of 21% year-over-year and continued clinical adoption of our technologies. Specifically, shipments to clinical and translational customers again grew more than 40% year-over-year, representing approximately 40% of total shipments in the quarter. The growth of our clinical end markets continue to be supported by adoption in oncology. Third quarter shipments to non-academic oncology customers grew 25% compared to last year. Shipments to all oncology customers has now grown to be approximately 20% of revenue. We shared our strategy to accelerate oncology adoption via our onco panel and liquid biopsy programs. We were pleased to recently launched the initial product from this strategy, the RUO version of our RO1 onco panel branded TruSight Tumor 15. This panel is based on initial standards defined by the Actionable Genome Consortium, and is expected to drive the adoption NGS for tumor analysis in translational research. To-date, customer feedback on the content of this product has been very positive, and the IUO version is on track for release to pharma partners in the next few months. We're also making progress on the RUO version of the R2 onco panel, which we expect to deliver in mid-2016 and will be available for use by our pharma partners in translational research study shortly thereafter. We recently joined the worldwide innovative networking consortium, a global network of leading academic, industry, and non-profit research organizations, working to make personalized cancer care reality for non-small cell lung cancer patients. As part of the consortium, we will provide a slightly modified version of our R2 onco panel for use in their clinical trials beginning in mid-2016, which is expected to provide us valuable clinical utility data. We're also making progress on our liquid biopsy program since our last update, including the recently announced collaboration with Memorial Sloan Kettering Cancer Center, which is focused on furthering the basic understanding of the biology of circulating tumor DNA, or ctDNA, in different cancer types. A series of seven clinical research studies will take place over the next three years, analyzing samples from approximately 1,000 patients with the aim of informing the development of liquid biopsy in clinical care. Additionally, we're beginning to see the launch of LDT products for specific ctDNA market segments from our customer base. Our market development activities in reproductive health also contributed to demand from clinical customers in the third quarter. Sales of our pre-implantation genetic screening, or PGS products, increased more than 25% compared to the third quarter of 2014. Further, we're in the late stages of enrolling patients in our STAR trial, which will measure the impact of PGS and morphology on IVF success rates. We expect to complete enrollment in this study in early 2016 and have an analysis of the interim results in the middle of the year. NIPT service revenue including test fees grew approximately 20% versus the third quarter of 2014, as we performed close to 50,000 tests. We recently signed a supply agreement with counsel that includes access to our NIPT patent pool, our 36 customer globally that has acquired these rights. I'm encouraged to see our customers developed NIPT LDTs, which further boost test adoption. Keep in mind as these licensees bring NIPT in-house. Revenue will decrease in services but increase in products. We're also encouraged to see the recent Anthem decision to reimburse for average risk and are optimistic that other top payers will follow suit. The availability of our next-generation solution VeriSeq NIPT will enhance our global opportunity. We're in the final stages of the European regulatory process for the software and hope to have CE mark shortly. We will follow with the CE mark on the VeriSeq NIPT product for distribution as an IVD solution early next year. Moving to arrays, in the third quarter, we saw a stabilization of market trends. Despite array revenue declining 17% year-over-year, now accounting for less than 15% of total revenue. Genotyping orders increased approximately 26% year-over-year, driven by DTC and agriculture customers, while pricing was stable compared to the second quarter. We now expect 2015 array revenue to decline low double-digits, or essentially – projecting essentially flat orders for the year, which bodes well for shipments in 2016. In the ag market specifically, we believe there's an opportunity to genotype millions of samples over the next few years. As a result, we're projecting array revenue to grow slightly in 2016. Additionally, our new product introductions including the drug DrugDev array, MethylationEPIC array, and the ImmunoArray are also expected to boost demand. We've received positive customer feedback on these introductions as order volumes are growing, and shipment of the arrays will commence shortly. In summary, while disappointed in the Q3 revenue shortfall, our conviction in our longer-term strategy in markets is stronger than ever. As we move into 2016, our product development pipeline is rich, and we're excited about opening the many large untapped markets ahead. I'll now turn the call over to Francis who will provide a detailed overview of our product results. Francis A. deSouza - President & Director: Thanks, Jay, and good afternoon everyone. I'm pleased to provide to further details on the performance our product families in the third quarter. As we shared a few weeks ago, the HiSeq family of products exceeded our expectations due to demand for high-throughput instruments in the Americas. On a year-over-year basis, this resulted in flat instrument revenue for our high-end portfolio, as lower HiSeq X shipments, which was expected given the record HiSeq X placements in the prior-year period, was fully offset by strength in the HiSeq 3000 and HiSeq 4000. In spite of the challenging comparison, HiSeq X interest was strong as orders and shipments exceeded our prior guidance. We are pleased with the health of our funnel, and as a result continue to project quarterly orders of 20 to 30 HiSeq X units, building off of our current installed base of more than 250 instruments. Demand for HiSeq X was generated from new customers, bringing the total customer count to 25, as well as existing sites expanding capacity to initiate additional projects. One example is the shipment of 10 HiSeq X instruments to the Broad to enable the National Heart, Lung, and Blood Institute's project to sequence 20,000 individuals. HiSeq 3000 and HiSeq 4000 continue to generate strong interest, due in part to customers accessing improved operating economics as well as adding capacity. HiSeq 4000 again was the leading platform sold, which lifted ASPs for the family of instruments compared to the prior year. In the quarter, commercial customers accounted for 40% of instruments shipped. We continue to benefit from pharmaceutical and biotechnology customers purchasing systems to aid in the discovery and validation of genomic-based targets, as well as molecular diagnostic, and reference laboratories ramping capacity to support NIPT and oncology-based LDTs. We remained bullish on our high throughput instrument portfolio, given its tremendous flexibility to address various budgets and scientific priorities. Moving to our benchtop instruments, as we previously shared, NextSeq and MiSeq instruments placements were lower than we had forecasted. NextSeq sales were stable both year-over-year and sequentially, and MiSeq had a very slight decline over the same time period. We are confident this result was not due to a change in the competitive dynamics as our win rates have remained stable at greater than 80%. We received our 4,000th MiSeq order during the quarter, with clinical and forensics customers supporting demand. Since launch, we have placed approximately 40 instruments into the forensic market, a figure we expect to continue to meaningfully ramp. Additionally, we continue to build the MiSeq menu to encourage further interest from new research and translational customers. The introduction of our TruSight HLA solutions and Tumor 15 panels, coupled with our new-to-NGS promotion bundle, have created a strong pipeline heading into the fourth quarter, as tracked opportunities have grown by more than a third compared to the levels seen entering Q3. We see this trend with NextSeq as well as the instrument pipeline has grown significantly sequentially. Approximately 50% of NextSeq orders came from clinical and translational centers. This is an upward trend as demand from our NIPT partners in China continue to penetrate the opportunity in the region. As a result, NIPT-specific NextSeq orders grew 60% versus the prior year. These market dynamics give us confidence that the benchtop segment will remain an important element of our portfolio going forward. In an effort to ensure that this is the case, we are continuing to add to our sales team and are heightening the focus on this segment. In informatics, we continue to see progress in the adoption of BaseSpace during the third quarter. App launches grew 13% sequentially as approximately 50,000 runs were uploaded from the 3,000 instruments connected to our cloud offering. We are forecasting these strong trends to continue, based in part on the recent introduction of the BaseSpace Professional and Enterprise editions, which fully integrated LIMS solutions and advanced infrastructure upgrades. These versions of BaseSpace will be available in the beginning of the first quarter to enable researchers to select some advanced services that are optimized to enhance their experience, while improving efficiency in sequencing labs. This introduction wouldn't have been possible without the recent acquisition of GenoLogics, a life science tools LIMS provider. Coupled with our BaseSpace offering, GenoLogics Clarity LIMS solution will provide a seamless sample to answer solution for our customers. I'll now turn the call over to Marc, who will provide a detailed overview of our third quarter results. Marc A. Stapley - Chief Financial Officer & Senior Vice President: Thanks, Francis. As Jay mentioned, total revenue grew 14% year-over-year, consistent with our preliminary estimate. On a constant currency basis, revenue grew 18%. Geographically, this result was driven by strength in the Americas, which was partially offset by lower-than-expected revenue growth in Europe and APAC, as we previously outlined. Strength in sequencing consumables and services was offset in part by instrument revenue, which declined 3% year-over-year to $145 million in the third quarter. Consumable revenue was $321 million, an increase of 23% compared to the third quarter of 2014 as higher demand for sequencing consumables was partially offset by a decline in arrays. Consumable revenue represented 58% of total revenue, up from 54% in the prior-year period and the 56% we saw in Q2. As we've previously shared, sequencing consumable revenue was robust, growing 36% over the Q3 of last year and $20 million sequentially, to approximately $270 million. Both HiSeq X and NextSeq utilization exceeded their respective guidance ranges. We are now forecasting NextSeq pull-through to remain elevated, and as a result are increasing the guidance range to $100,000 to $125,000 per instrument annually. We're also raising the HiSeq X pull-through guidance range to $650,000 to $700,000 per instrument as a result of positive utilization trends across the customer base. Again, this quarter, a handful of HiSeq X sites accounted for more than 70% of consumable shipments. But importantly, we saw early signs of success and increasing utilization across the many remaining customers. Additionally, we believe opening up the HiSeq X to non-human whole genome sequencing will boost utilization platform accounts that have access to agriculture or animal samples. MiSeq utilization was in our projected range of $40,000 to $45,000 and HiSeq pull-through per instrument excluding HiSeq X was in our projected range of $300,000 to $350,000. Year-to-date, we have removed approximately 90 instruments from our installed base figure to account for fully decommissioned older instruments, primarily due to the success of HiSeq 3000 and HiSeq 4000 replacing them in the lab. Services and other revenue, which includes the genotyping and sequencing services as well as instrument maintenance contracts, grew 23% versus Q3 2014 to $79 million. This improvement was driven by growth in NIPT services, which benefited from increased test send-out revenue, genotyping services, and extended maintenance contracts associated with the larger sequencing installed base. Turning now to gross margin and operating expenses, I will highlight our adjusted non-GAAP results, which exclude non-cash stock compensation expense and other items. I encourage you to review the GAAP reconciliation of non-GAAP measures included in today's earnings release. Also note that we have, as previously communicated, consolidated the results of our Helix joint venture into the results of Illumina, and accordingly all subsequent references to net income and earnings per share refer to the results attributable to Illumina stockholders after non-controlling interests. Our adjusted gross margin for the third quarter was 73.2%, flat versus the prior-year period and an increase compared to 72.4% in the second quarter, primarily due to the higher mix of consumables previously noted. Adjusted research and development expenses for the quarter were $90 million or 16.4% of revenue, higher compared to $85 million or 15.8% of revenue in the second quarter, due to the impact of additional head count on outside services. Adjusted SG&A expenses for the quarter were $115 million or 20.9% of revenue, an increase compared to $103 million or 19.2% of revenue in the previous quarter, due to expenses associated with the Helix joint venture, GenoLogics acquisition, outside services, and higher head count. Adjusted operating margins were 36%, compared to the 37.4% in the second quarter, lower sequentially due to the impact of Helix and GenoLogics as well as the impact of higher head count. Operating margin was lower compared to the 39.7%, reported in the third quarter of last year due to increased investment in R&D and SG&A to support our long-term growth. Our investments will continue into the fourth quarter, as we grow our business to support the opportunities ahead of us, although at a pace lower than experienced so far this year. Combining head count growth with our previously committed investments Helix, GenoLogics ERP, facilities and collaborations such as the one we recently announced with Memorial Sloan Kettering, we are expecting our fourth quarter operating expenses to grow $15 million to $20 million sequentially to $220 million to $225 million. In the third quarter, our stock-based compensation expense equaled $32 million. For the fourth quarter, we expect this to increase to $40 million due to the impact of our annual grant program, which occurs in December along with the growing employee base. Our non-GAAP tax rate for the quarter was 28.6% compared to 21.3% in the third quarter of last year, which was lower than typical as a result of the reversal of reserves related to prior-year returns. Non-GAAP net income was $120 million for Q3, resulting in non-GAAP EPS of $0.80. This compares to non-GAAP net income and EPS of $114 million and $0.77 respectively in the third quarter of 2014. The impact of foreign exchange lowered Q3 non-GAAP EPS by approximately $0.05 relative to last year. We reported GAAP net income of $118 million or $0.79 per diluted share in the third quarter, compared to net income of $93 million or $0.63 per diluted share in the prior-year period. This quarter includes a $25 million tax benefit resulting from the elimination of stock compensation expense that our U.S. entity had charged to foreign subsidiaries and the cost-sharing agreements over a multi-year period. The elimination of these charges was undertaken in consultation with our external audit firm following a ruling granted to an unrelated third party in Q3. Going forward, we will no longer cross-charge stock competition expense unless or until the ruling is overturned, which we believe is unlikely based on the facts that exist today. Should that occur, we would correspondingly record a significant charge in that period. Cash flow from operations equaled $181 million. DSO increased to 68 days compared to 62 days last quarter due to a higher percentage of shipments in the third month, which is attributable to a combination with a typical deceleration we've seen in July and August as well as our ERP implementation at the end of July. Inventory increased slightly to $234 million. Capital expenditures in Q3 were $29 million, resulting in $152 million of free cash flow. During the quarter $207 million of the 2016 0.25% convertible bonds were settled, leaving slightly more than $105 million remaining. We repurchased 188,000 shares for $37 million, leaving us with $112 million under our previously announced 10b5-1 program and $96 million of discretionary authorization. Turning now to our expectations for the remainder of 2015, we project approximately 18% total company revenue growth and 21% growth on a constant currency basis, given current exchange rates. Fourth quarter revenue is expected to be $570 million, which includes a $10 million currency headwind compared for the prior year. We have updated our 2015 non-GAAP EPS projection to $3.29 to $3.31, which includes expected fourth-quarter non-GAAP EPS of $0.78 to $0.80. These projections incorporate a full-year pro forma non-GAAP tax rate of 27%, which assumes the 2015 federal R&D tax credit and other tax extenders are passed in the fourth quarter. If these items are not passed, our annual tax rate would increase by approximately a 150 basis points. In conclusion, we believe the investments we are making are necessary to drive product innovation as well as market development and expansion, enabling us to catalyze the broad adoption of genomics in 2016 and beyond. Having said that, we continue to be diligent about the nature and timing of our investments. Thank you for your time. We will now move to the Q&A session. To allow full participation, please ask one question, and rejoin the queue if you have additional questions. Operator, we'll now open the lines.