Operator
Operator
Good day, ladies and gentlemen, and welcome to the Illumina, Inc. Q1 2016 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. As a reminder, this call is being recorded. I would now like to turn the conference over to Rebecca Chambers. Please go ahead. Rebecca Chambers - Vice President-Investor Relations & Treasury: Thank you, operator, and good afternoon, everyone. Welcome to our earnings call for the first quarter of fiscal year 2016. 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 will 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, Chairman and Chief Executive Officer; Francis deSouza, President; and Marc Stapley, Executive Vice President, Chief Financial Officer and Chief Administrative Officer. Jay will focus on our Q1 results, Francis will provide the outlook for our business, and Marc will review our financial results and updated guidance. 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 on 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 filed with the Securities and Exchange Commission, including Illumina's most recent Forms 10-Q and 10-K. Before I turn the call over to Jay, I would like to let you know that our Q1 earnings presentation will be available on the Investors section of our website shortly. We plan to reference this document during today's call. With that, I will now turn the call over to Jay. Jay T. Flatley - Chairman & Chief Executive Officer: Thanks, Rebecca, and good afternoon, everyone. As we shared a few weeks ago, first quarter revenue was $572 million, an increase of 6% over the prior year period and lower than the guidance we provided in January. Our analysis subsequent to the pre-announcement has identified two key contributors to the shortfall: orders we booked that were not recognizable as revenue; and instrument orders that we were expecting, but did not receive. Additionally, after quarter-end, we received a disappointing outlook from Europe, which is central to the guidance reduction for the remainder of the year. I will address the Q1 factors, and Francis will address our outlook and action plan. The majority of the shortfall in Q1 resulted from orders booked that did not translate to revenue. A combination of factors contributed, including capacity constraints in array manufacturing resulting in back orders; orders that were received late in the quarter, resulting in systems in transit and therefore not converted to revenue; customer initiated requests for delayed shipment or conditions outside our control delayed revenue recognition; and partial revenue deferrals due to increase in complexity of large deal structures, particularly in the case of high-throughput instruments, including the HiSeq X. Some of these deferrals will be recognized in Q2, while others will convert to revenue over the rest of the year. Some were controllable by us and some were not, but none are related to fundamental market demand. Individually, each was less than 1% of revenue, and that happens to a degree every quarter, but the combined effect was larger than we expected. The second factor was HiSeq orders that were forecasted but were not received, accounting for $9 million of the shortfall. As a consequence, we shipped 19 fewer HiSeq 2500, HiSeq 3000 and HiSeq 4000 instruments than anticipated, valued at $14 million, which was partially offset by strength in other portions of the portfolio. We had anticipated sequential growth of 11 units rather than a decline of eight units, which led to flat placements year-over-year. Over the last several weeks, we've gone through a detailed analysis of the underlying drivers deal by deal. There were no dominant themes, but we did see a collection of factors, including delays in funding release, customers opting to purchase NextSeqs, and one-off situation such as pending lab moves, financing deliberations, contract reviews, or an upcoming regulatory audit. While outsourcing to service providers was also cited by a few customers, this is not a significant driver of our forward projection. This feedback confirmed our view on questions of competition and market capacity. While we can never be certain a few customers did not delay purchases to assess other platforms, our win rates remained stable; and to our knowledge, we did not lose a competitive deal in Q1. We also did not get any information to indicate that excess market capacity was a factor. As you can see in our investor deck, high-throughput utilization as a percentage of available sequencing capacity has been on an upward trend since Q3 2014 when normalized for one large order that we shipped in Q3 2015. Run data collected from BaseSpace, which represents about a third of the high-throughput installed base, confirms this analysis, showing roughly flat utilization for legacy HiSeq instruments like HiSeq X, HiSeq 3000 and HiSeq 4000. Newly announced initiatives, like the Chinese precision medicine program to sequence millions of genomes and the AstraZeneca project to access 2 million genomes, create the confidence that today's sequencing capacity represents but a small fraction of that necessary to meet the growing demand for population sequencing programs. Focusing now on products. Orders for HiSeq X exceeded our expectations and we added four new customers, bringing the total to 31. Our outlook remains robust, at 20 to 30 instrument orders per quarter. HiSeq X Consumables also beat our forecast despite the timing of customer shipments lowering pull-through to below the guidance range. On a four quarter basis, which normalizes the impact of shipment timing, X utilization averaged $650,000 to $750,000 annually, a range we feel comfortable with going forward. HiSeq pull-through is in our projected range of $300,000 to $350,000. For modeling purposes, we've removed 95 HiSeqs from our installed base, bringing the figure to just over 2,000 instruments, reflecting the units taken offline due to adoption of newer machines. Our benchtop instrument portfolio performed well in the quarter, and the outlook is consistent with our expectations coming into the year. This is being driven by lower than expected cannibalization of MiSeq, strong initial interest in MiniSeq and NextSeq adoption for NIPT in China. Benchtop consumables were strong in Q1, as both MiSeq and NextSeq saw utilization above their respective guidance ranges. Microarrays were also an emerging bright spot this quarter, as revenue grew 1% versus the prior year period to almost $90 million and orders dramatically exceeded our expectations with growth of 85%. A new Consortium Array, which will begin shipping in Q4, and demand from DTC customers, contributed to the strong order result. Shipments to our clinical customers grew approximately 20% in the quarter. As we've noted on multiple earnings calls, we've been expecting some NIPT services customers to shift to running samples in-house on our sequencers, and a significant part of that shift occurred this quarter. Normalizing for the effect of the lower revenue, because we're not getting the full service revenue, our remaining clinical customer base revenue grew 24%. NIPT shipments grew 10%, or 28% after adjusting for the shift, versus the prior year. We now believe most payers will next assess average risk coverage decisions in 2017, which is later than we had anticipated. Despite this, the rate of adoption is meeting our forecast, and we expect further acceleration as reimbursement decisions are made. We believe the delay is a matter of focus by the labs that are working to obtain a network designation for existing coverages, as opposed to driving incremental average risk coverage for a faster return on investment. Oncology shipments grew 9% adjusted for the large HiSeq X shipments seen in the first quarter of last year. This growth rate is lower than that we typically see from this market, due to a large number of orders shipped in the prior year period. We continue to expect expanded adoption in 2016, which will be fueled in part by the launch of TruSight Tumor 170 later this year. In summary, while we're not happy with our performance in Q1, we do not believe our results are related to a change in fundamental market demand. Instead, timing of instrument orders is creating late quarter revenue uncertainty, some of which we can and will take specific actions to mitigate, and unique customer situations impacting the HiSeq order rate. With the lower European forecast, it was important that we realign our full-year expectations. We continue to believe that demand for next-generation sequencing is far more robust than our first quarter results or the outlook our European forecast suggests. I'll now turn the call over to Francis. Francis A. deSouza - President & Director: Thanks, Jay, and good afternoon everyone. Today, I plan to provide further details on our outlook and action plan. Europe revenue declined 2% year-over-year in Q1, missing our projections, and we are forecasting low-to-mid single-digit growth for the full-year. Revenue from the Americas grew 14% representing a slightly slower start than we anticipated for the reasons Jay outlined, but we remain confident in the region's full-year projection of mid-teens growth. Asia Pacific revenue declined 5% as forecasted due primarily to a large HiSeq X comparable. During the quarter, we began to see customer purchasing patterns in Japan improved as research funds are now being released. It's too early to call this a resurgence, but the signs are certainly more positive. Our Asia Pacific region is also forecasting mid-teens growth for the year. The Q1 challenges are responsible for a minimal change in full-year outlook. With the benefit of two additional weeks of analysis since our pre-announcement, we are more confident that Q1 was a result of operational challenges and not market demand. By far, the largest driver of our lowered guidance is our lack of visibility in Europe, as evidenced by the drop in the region's full-year forecast three months after we completed our budget. We're taking steps to enhance visibility and improve our execution in the region. In the meantime, we have incorporated the reduced outlook from Europe into our projection. We're focusing on three areas to deliver on our full-year. First, we're making improvements to our sales process. To address the variability in instrument orders and shipments during the last months of the quarter, we're focusing the sales team on early closure of instrument orders. In addition, large instrument contracts including those for HiSeq X have become more complex, particularly in Europe. And so we are simplifying and standardizing deals. Finally, we're building out our manufacturing capacity for arrays, so that we're able to clear the back orders, and meet the increasing demand. Second, we are committed to improving the execution and outlook in Europe. As we mentioned a few weeks ago, we recently brought in an interim sales leader in Europe, who has already established accountability and ownership for the revised forecast and is driving to the updated expectations. He has already put in place greater discipline around opportunity management, accuracy of our CRM data and quoting. In addition, we're making good progress in our search for a permanent general manager with large global company experience to ensure that our European organization realizes its full potential. The last step in our plan is focused on expense management. Last year we added close to 900 employees, 500,000 square feet of real estate commitments and a new global ERP system. While these investments were necessary to support both the growth we have experienced and our ongoing market opportunities, we recognize the need to meaningfully slow down the pace of investment in 2016, given our updated outlook. We do not expect to have broad changes to our product portfolio or development pipeline but do have other opportunities to delay initiatives that are less impactful to the long-term outlook. We're working on a 2016 re-plan, and have incorporated those improvements into our guidance for the remainder of the year. As a result excluding GRAIL and Helix, our operating margin target for the year is expected to be 34.5%. While disappointing our Q1 results have not dampened our conviction and our market opportunity or our ability to deliver innovative technology to capture those markets. I am personally committed and excited to move this organization to realize our mission, benefit patients and deliver shareholder value. I will now turn the call over to Marc, who will provide a detailed overview of our first quarter results. Marc A. Stapley - Executive Vice President, Chief Financial Officer & Chief Administrative Officer: Thanks, Francis. While revenue for the quarter missed our guidance, orders of over $700 million significantly beat our expectations. We built more than 100 million in sequencing consumable backlog, most of which is expected to be delivered this year. As a reminder, we typically see higher sequencing consumable orders in the first quarter, ahead of annual list price increases. Instrument revenue declined 20% year-over-year to $118 million, given the large HiSeq X shipments in the first quarter last year, which accounts for more than $30 million of decline. Consumable revenue was of $361 million, an increase of 17% compared to the first quarter of 2015. Sequencing consumable revenue grew 24% over Q1 of last year to approximately $300 million. Services and other revenue, which includes genotyping and sequencing services as well as instrument maintenance contracts, grew approximately 12% versus Q1 2015 to $89 million. This improvement was driven by extended maintenance contracts associated with the largest sequencing installed base and genotyping services, partially offset by a decline in NIPT service revenue, given the shift to in-house testing as expected. Going forward, we expect (14:29) to at least partially offset the further impact from the transition of these two customers. Turning now to gross margin, operating expenses, I will highlight on 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 as well as our GAAP EPS guidance, both of which can be found in today's earnings release and presentation. Please note that all subsequent references to net income and earnings per share refer to the results attributable to Illumina stockholders. Our adjusted gross margin for the first quarter was 71.7%, flat compared to the fourth quarter as the benefit of favorable consumables mix was offset by lower absorption. Year-over-year, adjusted gross margins contracted 50 basis points as the positive impact of consumables mix was more than offset by lower instrument margin associated with fewer HiSeq X shipments as well as the decline in services margin. Adjusted research and development expenses for the quarter were $113 million or 19.8% of revenue, including $5 million attributable to GRAIL and Helix. This compares to $103 million or 17.5% of revenue in the fourth quarter, higher due to head count additions and investments in GRAIL, Helix, and development projects including projects including Project Firefly. Adjusted SG&A expenses for the quarter were $125 million, or 21.9% of revenue, including $3 million attributable to GRAIL and Helix. This compares to $124 million, or 20.9% of revenue, in Q4. Adjusted operating margins were 30.1% compared to 33.4% in the fourth quarter and 39.3% in the prior-year period. Excluding GRAIL and Helix, operating margins were 31.6% in the first quarter. The year-over-year decline is attributable to the lower gross margins and increased employee-related expenses. Stock-based compensation expense equaled $35 million, flat compared to Q4. Our non-GAAP tax rate for the quarter was 25.5%, compared to 24.5% in the first quarter of last year and non-GAAP net income was $106 million. This resulted in Q1 non-GAAP EPS of $0.71, which included approximately $0.04 and $0.02 of dilution from GRAIL and Helix respectively. This quarterly result compares to non-GAAP net income and EPS of $135 million and $0.91 in the first quarter of 2015 respectively. We reported first quarter GAAP net income of $90 million, or $0.60 per diluted share, compared to net income of $137 million, or $0.92 per diluted share, in the prior-year period. As a reminder, prior-period results include a pre-tax gain of $15 million from the partial sale of our minority interest in Sequenta when acquired by Adaptive Biotechnologies. Cash flow from operations equaled $40 million, lower versus the prior year due to the impact of the operating expense growth. Q1 DSO totaled 64 days, equal to last quarter, and inventory rose to $288 million, given the quarterly shortfall in sequencing instruments, and a continued build-up of consumable safety stock. Capital expenditures in Q1 were $53 million, higher than the $37 million in the prior-year quarter, due primarily to our real estate build-outs. Consequently Q1 free cash flow was a negative $14 million. During the quarter, we retired the remaining $76 million of the 0.25% 2016 convertible notes and ended the quarter with approximately $1.34 billion in cash and short-term investments including the cash balances of GRAIL and Helix. Looking forward, we now expect total company revenue growth of 12% year-over-year. Beyond the first quarter miss (18:09), the additional decline versus our original expectation of 16% is due to the lowered outlook for Europe, which went from high-teens growth to low-single digits to mid-single digits, including a smaller contribution than planned from the Genome England (sic) [Genomics England] (18:19) project. Our outlook in the Americas and Asia Pacific regions is much more robust as both are expected to grow in the mid-teens for the full year, roughly in line with our expectations due in part to strong orders in the first quarter. For these regions in the second half, we expect to see HiSeq sales increase but remain short of our original expectation. We believe this will be more than offset by (18:40) MiSeq placements, given lower than expected cannibalization, as well as an increase in the rate revenue (18:45), NextSeq consumables and HiSeq X placements. We also continue to expect strong adoption across our four clinical markets in 2016. We are forecasting Q2 revenue of $590 million to $595 million driven by sequential seasonality in Japan and roughly flat HiSeq X shipment. We're not forecasting an uptick in other HiSeq instrument shipments until the second half. This Q2 revenue guidance implies a meaningful back half acceleration. Our confidence in delivering for this projection stems from our existing backlog, a third of which is shippable in Q3 and Q4, and our pipeline. We are projecting Q2 non-GAAP EPS to be in the range of $0.72 to $0.74 as higher revenue is expected to be largely offset by a sequential increase in operating expenses both from the head count additions in the first quarter and additional GRAIL and Helix spend. The steps we are taking to reduce spending will have a marginal impact in Q2 and a more meaningful impact in the second half of the year. We anticipate significant EPS leverage in the second half, driven by the acceleration of the revenue growth and our spending action. For the full year, non-GAAP EPS is expected to be $3.35 to $3.45, which includes GRAIL dilution of $0.20, an increase of $0.05 versus our prior estimate. Illumina is retaining almost all of the GRAIL losses in net income attributable to Illumina shareholders, significantly greater than our majority ownership percentage, due to an unexpected accounting treatment. We are in discussions with GRAIL regarding updating the equity structure. Our updated non-GAAP EPS guidance and GRAIL dilution commentary includes our expectation that we will continue to recognize most of the losses in the second quarter and that drops substantially in the second half to closer to our ownership, based on the structural changes that are being contemplated in Q2 and the accounting treatment we are anticipating. Any delays in this timeline could have a negative impact of up to $0.04 per quarter in the second half. In closing, as a management team, we have a number of matters to address that we have outlined today, including our in quarter linearity, our execution in Europe, and rate of investment and GRAIL equity structure. Resetting our outlook so significantly is uncharacteristic of our company and unacceptable to us as a team. We are committed to delivering strong results consistent with our track record and our confidence in the long-term opportunity for our business remains high. 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 will now open the line.