Illumina Q4 2022 Earnings Call Transcript

Presentation

[Operator]

Good day, ladies and gentlemen, and welcome to the Fourth Quarter 2022 Illumina Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to Salli Schwartz, Vice-President of Investor Relations.

[Salli Schwartz, Vice-President of Investor Relations at Illumina]

Hello, everyone, and welcome to our earnings call for the fourth-quarter and year end 2022. 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 Francis deSouza, President and Chief Executive Officer; and Joydeep Goswami, Chief Financial Officer and Chief Strategy and Corporate Development Officer. Francis will provide an update on the state of Illumina's business and Joydeep will review our financial results, which include GRAIL. As a reminder, GRAIL must be held and operated separately and independently from Illumina pursuant to the interim measures ordered by the European Commission which prohibited our acquisition of GRAIL under the EU merger regulations. 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 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 available information, and Illumina assumes no obligation to update those 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'll now turn the call over to Francis.

[Francis deSouza, President and Chief Executive Officer at Illumina]

Thank you, Sally. Good afternoon, everyone. 2023 is off to an exciting start for Illumina and for genomics, and I'm pleased to announce that we've started shipping the first NovaSeq X Plus systems to customers. Later in my remarks, I'll share how we're scaling our manufacturing and distribution infrastructure to ship 40 units to 50 units in Q1 and over 300 units for the year. First, I'll cover our financial results for both the fourth-quarter and full-year 2022. Illumina delivered fourth-quarter revenue of approximately $1.1 billion and full-year 2022 revenue of approximately $4.6 billion, in-line with the upper-end of our revised guidance range. We placed more than 3200 instruments in 2022, increasing our installed-base to approximately 23,000 instruments worldwide.

Delving now into each of our platforms starting with high-throughput. We've had a fantastic customer response to the NovaSeq X-Series launch. Both orders and the advanced pipeline continued to grow with strong global interest with orders for more than 25 countries, four times more than in the first-quarter of the NovaSeq 6,000 launch. We're also seeing stronger-than-expected clinical adoption and orders from new to-high throughput customers who are bringing sequencing in-house due to NovaSeq X's ease-of-use and cost benefits. The NovaSeq X has had the strongest pre-order book of any Illumina instrument launch and this demand will capitalize a multi year upgrade cycle. We also shipped more than 340 NovaSeq 6,000 in 2022 with more than one-third of those instruments for oncology testing and nearly half to new-to-high throughput or new to Illumina customers. Placements were strong in the first-half of 2022 even after a record 2021. Second-half placements were tempered by growing customer excitement for the NovaSeq X-Series. Across 2022, average consumable pull-through for the NovaSeq 6,000 was approximately $1 million per instrument.

Moving to mid-throughput. In 2022, we shipped a record 1,215 instruments and saw the fourth consecutive record year for NextSeq shipments. The fourth-quarter of 2022 was also the highest quarter on record for NextSeq 1K, NextSeq 2K shipments. Customers appreciate NextSeq 1K, NextSeq 2K's unique capabilities as the only mid-throughput sequencer with built-in analysis and the first mid-throughput instrument to include the 2 by 300 kits. Close to 25% of NextSeq 1K, NextSeq 2K units in 2022 were placed new to Illumina customers. For low-throughput in 2022, we shipped approximately 1,670 instruments bringing nearly 700 new customers to Illumina. Our low-throughput instruments consistently opened new geographies and applications, while serving as an effective entry point to sequencing.

Shifting to our markets. Our clinical markets currently include testing for oncology, reproductive health and genetic disease. In 2022, shipments to clinical customers represented 45% of core Illumina consumables. For 2022 oncology testing consumables grew 7% year-over-year from utilization of NGS-based molecular profiling across early detection, therapy selection and minimal residual disease. We see expanding opportunities for our oncology products globally. For our TruSight Oncology 500 distributed therapy selection assay, sample volume grew approximately 60% year-over-year across more than 500 accounts and for 2023, we expect more than $100 million in revenue for TSO 500. Also in oncology, GRAIL continues to have strong demand from consumers, physicians, health systems and payers. Galleri is the only multicancer early detection test in a 40 plus billion-dollar market and it had the fastest first year revenue ramp in cancer screening test history. GRAIL has established over 60 partnerships with leading health systems, self-insured employers and other healthcare stakeholders. In 2022 alone, more than 4,500 providers ordered the test, contributing to the more than 60,000 Galleri test orders that have been received to date. The Galleri test has received FDA breakthrough designation and was recognized by Time as one of the best inventions of 2022, by the Atlantic as one of the breakthroughs of the year, and by Fast Company as one of the world changing ideas of 2022. Galleri was also featured in an AARP health story on game-changing medical breakthroughs improving lives today. GRAIL expects this exciting momentum to continue and to translate into an expected revenue CAGR of 60% to 90% over the next five years.

Beyond oncology, genetic disease testing had a record quarter in Q4 and another strong year in 2022. For 2022, GDT consumable shipments grew 11% year-over-year, driven by broader adoption of whole-genome sequencing globally and increased demand for rare disease treatment. We also saw additional evidence generation with the European Society of Human Genetics updating its guidelines to recommend increased adoption of whole-genome sequencing in diagnostics, as well as increased coverage for rare and undiagnosed genetic diseases. Recently, two of the largest health insurance companies in the US-based on the number of patients served announced that whole-genome sequencing will be covered for patients with rare and undiagnosed genetic diseases starting this quarter. And AIM Specialty Health, which provides lab benefits management services for more than a dozen regional health plans in the US now considers comprehensive genomic profiling medically necessary for appropriate patients with advanced cancers. Tens of millions more Americans will be covered, a huge win for patients and our customers and for Illumina.

Turning to our research and applied markets, consumable shipments represented 55% of Core Illumina consumables in 2022. Boosting the diversity in genetic databases is a significant need for our customers as they work to understand the underlying cause of disease. Genomics, combined with clinical information, can increase drug discovery success by up to a 150% and reduce costs by up to 50%. To achieve this, we need more samples over time and for more diverse populations. We recently announced an agreement with Amgen and its subsidiary deCODE genetics to sequence the first 35,000 genomes in our collaboration with Nashville Biosciences. This sample cohort will represent the largest dataset of African Americans to-date as we aim to accelerate equitable access to precision help therapies, and they've already begun sequencing the first samples.

Moving now to 2023, we're excited for this launch here and have now started shipping NovaSeq X plus systems to our first customers. We're on-track to ship 40 to 50 NovaSeq X instruments in Q1 and more than 300 instruments in 2023. To accomplish this, we boosted our operational capabilities. We've built state-of-the art consumable manufacturing facilities in the UK, Singapore and San Diego, adding nine new production lines. At launch, we already have two months to three months of inventory for each of the six core consumable SKUs. In our instrument manufacturing facility in Hayward, we are fully staffed and ramping-up production and capacity. Right now, there are more than 60 NovaSeq X instruments in various stages of the production process. All primary and secondary sequencing metrics are meeting or exceeding specifications. In addition, we've taken steps to ensure our supply-chain is strong. We began adding and onboarding new suppliers two years ago to secure the material and component supply fueling NovaSeq X production to guide our customers as they receive the first NovaSeq X shipments. In January, we brought together more than 800 sales team members in a three-day training session, giving them new tools and insights to support customers as they accelerate genomics worldwide with this powerful new instrument. The team is energized to bring these new capabilities to market and excited to see the outcome of years of preparation. We are confident that our organization's scale, reach and experience will enable our customers to sequence more samples, run more analyses, and obtain more data than ever before. And NovaSeq X unlocks greater elasticity. We expect average booking [Phonetic] for the X to comfortably exceed NovaSeq 6,000 over time. Illumina will remain focused on supporting our valued customers with transformative innovations and continue to advance our roadmap to accelerate the genome era. Customers' interest worldwide continues to be very strong and they are eager to harness the capabilities of the X, the most powerful, most sustainable and most cost-effective sequencer ever developed to further unlock the power of the genome. You'll hear more about the customer experience and data at AGBT this week.

Now before I turn the call over to Joydeep, I'd like to thank him and welcome him to the role as Illumina's Chief Financial Officer. With over two decades of experience in the industry, Joydeep brings strategic expertise, deep industry knowledge and extensive global business experience to the role. He is a proven and disciplined leader with a strong track-record of creating value, and an ideal partner to help drive the next phase of Illumina's growth. I'll now turn the call over to Joydeep for more detail on the quarter and our full-year outlook.

[Joydeep Goswami, Chief Strategy & Corporate Development Officer at Illumina]

Thanks, Francis. Thanks for the kind introduction. I'm excited to step into the role on a permanent basis and continue to work with all of you. I'll start by reviewing our consolidated financial results followed by segment results for core Illumina and GRAIL, then conclude with additional remarks on our current outlook for 2023. I will be discussing non-GAAP results, which include stock-based compensation. I encourage you to review the GAAP reconciliation of these non-GAAP measures which can be found in today's release and in supplementary data available on our website.

In the fourth-quarter, consolidated revenue was $1.08 billion, down 10% year-over-year, or down 7% on a constant-currency basis net of the effects of hedging. Non-GAAP earnings were $22 million or $0.14 per diluted share including dilution from GRAIL's non-GAAP operating loss of $159 million for the quarter. Non-GAAP earnings per share were lower than expected due to approximately $87 million in incremental tax expense from the R&D capitalization requirements that were not repealed in Q4 2022 despite broad bipartisan support. The incremental tax expense includes approximately $80 million recorded in Q1 through Q3 that was ultimately not reversed in Q4. Our non-GAAP tax rate was 29.3% for the quarter and 26% for the full-year 2022, which increased from 15.6% in Q4 2021 and 17.3% in fiscal year 2021, primarily due to the impact of R&D capitalization requirements. Our non-GAAP weighted-average diluted share count for the quarter was approximately $158 million.

Moving to segment results. I'll start by discussing the financial results of Core Illumina. Core Illumina revenue was $1.07 billion, down 11% year-over-year, or down 8% on a constant-currency basis, net of the effects of hedging. For Illumina, sequencing consumables revenue of $687 million was down 13% year-over-year. As expected, growth driven by pull-through on the increased installed-base was offset by delayed recruitment for some large research projects in the Americas and Europe, the ongoing impact of COVID disruptions in China, the year-over-year impact of customer inventory management, the anticipated decrease in COVID surveillance revenue, and headwinds from foreign-exchange rates. Sequencing instruments revenue for Core Illumina declined 24% year-over-year to $146 million, driven primarily by the lower NovaSeq 6,000 shipments in advance of the availability of NovaSeq X. The decline was partially offset by another quarter of record NextSeq 1K, NextSeq 2K shipments, which grew 31% year-over-year as we continue to see strong adoption by new to Illumina customers and demand for our new 2 by 300 kits that bring longer lead capabilities to our mid-throughput platform for the first time.

During the fourth-quarter, COVID surveillance contributed approximately $20 million in total revenue comprised of $19 million in sequencing consumables and $1 million in sequencing instruments. This was in-line with our expectations and down $30 million year-over-year, driven primarily by lower sample volumes. Core Illumina sequencing service and other revenue of $131 million was up 24% year-over-year, driven primarily by higher instrument service contract revenue on a growing installed-base as well as an increase in oncology and IVD partnership revenue.

Moving to regional results for Core Illumina. Revenue for the Americas was $577 million, down 7% year-over-year and EMEA revenue of $301 million represented a 14% decrease year-over-year, or a 10% decrease on a constant-currency basis. As expected, the base business in both regions was impacted by an anticipation for NovaSeq X and the slowdown in COVID surveillance and research I mentioned earlier. We continue to see strong demand for NextSeq 1K, NextSeq 2K with record shipments in the Americas up nearly 50% year-over-year, driven by strength across both research and clinical. In addition, NovaSeq Dx shipments exceeded expectations in the first-quarter of launch with strong early demand by clinical customers in Europe. Greater channel revenue of $94 million represented a 22% decrease year-over-year, or a 14% decrease on a constant-currency basis. The region continued to be impacted by COVID lockdowns that resulted in lower sample volumes year-over-year. We continue to expect our business in China to be impacted by headwinds from COVID related disruptions, exchange rates, and slowing GDP growth in the region at least through the first-half of 2023. Finally, APJ revenue of $93 million declined 10% year-over-year, or 4% on a constant-currency basis, net of the effects of hedges. Strong growth across clinical markets was more than offset by the conclusion of a large research project in Japan and delayed high-throughput instrument purchases due to the introduction of NovaSeq X.

Moving to the rest of Core Illumina P&L. Core Illumina non-GAAP gross margin of 67.3% decreased 430 basis-points year-over-year, primarily due to less fixed-cost leverage on lower manufacturing volumes. Core Illumina non-GAAP operating expenses of $528 million were down $52 million year-over-year, primarily due to cost-containment initiatives, lower performance-based compensation expense and a onetime partnership related expense in Q4 2021.

Transitioning to the financial results for GRAIL. GRAIL revenue of $23 million for the quarter grew 130% year-over-year driven primarily by accelerating adoption of Galleri, as well as higher contributions from MRD pharma partnerships due to a milestone payment in Q4 2002 that GRAIL does not expect to repeat in Q1 2023. GRAIL non-GAAP operating expenses totaled $166 million and increased $35 million year-over-year, driven primarily by continued investments in clinical trials and to scale GRAIL's commercial organization.

Moving to consolidated cash-flow and balance sheet items. Cash flow provided by operations was $147 million. Fourth-quarter 2022 capital expenditures were $88 million and free cash flow was $59 million. We did not repurchase any common stock in the quarter. We ended the quarter with approximately $2 billion in cash, cash equivalents and short-term investments. Cash as of the close of the quarter included $991 million in net proceeds from the term notes issued on December 13, 2022 which will be used to repay upcoming debt maturities in 2023.

Moving now to 2023 guidance. We expect full-year consolidated revenue to grow 7% to 10% to approximately $4.9 billion to $5.03 billion. We expect full-year 2023 Core Illumina revenue to grow 6% to 9% to approximately $4.83 billion to $4.96 billion. These ranges include an anticipated headwind from COVID surveillance of approximately 200 basis-points as well as a year-over-year headwind from foreign-exchange rates. We expect quarterly revenue to ramp sequentially through 2023 with linearity trends similar to what we saw in 2017 when we launched the NovaSeq 6,000. GRAIL is expected to deliver revenue in the range of $90 million to $110 million for 2023 reflecting year-over-year growth of 82% at the midpoint, driven by accelerating adoption of the Galleri test. For fiscal 2023 at the midpoint of our revenue guidance range, we expect Core Illumina sequencing revenue to grow approximately 8% year-over-year. This includes intercompany sales to GRAIL of approximately $35 million which are eliminated in consolidation. We expect Core Illumina sequencing instrument growth of approximately 9% year-over-year, driven by the NovaSeq X upgrade cycle and continued momentum in mid-throughput. We expect Core Illumina sequencing consumables growth of approximately 8% year-over-year, primarily driven by the NovaSeq X launch as customers build consumables inventory and ramp utilization, as well as continued growth in our mid throughput consumables due to the growing installed-base. This growth will be partially offset by further reduced COVID surveillance revenue. We expect annual pull-through for NovaSeq 6,000 of approximately $900,000 to $1 million per system in 2023 as customers transition to NovaSeq X. We expect pull-through for NextSeq 1K, NextSeq 2K in the range of $120,000 to a $170,000 per system in 2023 as the record instrument placements in '22 and continued strong placements in 2023 are brought fully online. We expect the remainder of our pull-through ranges to be in-line with historical guidance. We also expect revenue from COVID surveillance of approximately $30 million in 2023, which reflects a year-over-year headwind of $105 million or approximately two percentage points. We expect consolidated non-GAAP operating margin of approximately 8% and Core Illumina non-GAAP operating margin of approximately 22% for 2023. These margins reflect one, an increase in core Illumina operating expenses from 2022, primarily driven by normalization of our performance-based compensation; two, a temporary decrease in gross margins as we launched the NovaSeq X, consistent with what we saw in 2017 when we launched NovaSeq 6,000; and three, an increase in GRAIL operating expenses due to the ongoing investments to support the FDA application NHS trial and to continue to scale GRAIL's commercial organization.

We also expect a consolidated non-GAAP tax rate of approximately 36%, which includes an approximately $75 million impact from the R&D capitalization requirements. If these requirements are repealed in 2023, we expect our 2023 non-GAAP tax rate to be approximately 15%. We expect consolidated non-GAAP earnings per diluted share in the range of $1.25 to $1.50, which includes dilution from GRAIL's non-GAAP operating loss of approximately $670 million. And finally, we expect non-GAAP diluted shares outstanding for fiscal 2023 to be approximately 160 million shares.

For the first quarter of 2023, we expect consolidated revenue in the range of $1.05 billion to $1.07 billion for Q1 2023, reflecting a sequential decrease of 212 basis points from Q4 2022 at the midpoint, primarily driven by historical seasonality of our core business due to year-end budget flushes not repeating in the first quarter, partially offset by an increase in high-throughput instrument shipments due to the launch of NovaSeq X in Q1; and a decrease in GRAIL revenue of approximately $5 million due to a milestone payment in Q4 2022. We expect quarterly revenue to grow sequentially through 2023, driven by a ramp in NovaSeq X shipments and utilization, recovery from COVID disruptions in China, accelerating adoption of Galleri, and an expected mitigation of macroeconomic headwinds in the second half of 2023.

For the first quarter, we expect consolidated non-GAAP operating margin of approximately 1% and Core Illumina non-GAAP operating margin of approximately 17%. We expect operating margins to improve throughout 2023 as revenue ramps and we scale our production of NovaSeq X and leverage the fixed cost of the manufacturing base. We expect net other expense of approximately $9 million, primarily due to the interest expense on our new bond issuances. Lastly, we expect non-GAAP diluted shares outstanding of approximately 160 million shares, in line with fiscal 2023. I'll now hand the call back over to Francis for his final remarks.

[Francis deSouza, President and Chief Executive Officer at Illumina]

Thank you, Joydeep. Illumina continues to prioritize innovation. We know our customers invest in our road map, not just our instruments. I talked about the NovaSeq X Series earlier. The X is a powerful catalyst for 2023 and beyond. We also prioritized sustainability. NovaSeq X features a 90% reduction in packaging waste and weight and a 50% reduction in plastic usage compared to the NovaSeq 6000. The enablement of ambient temperature shipping of reagents will result in nearly 500 tons of dry ice savings per year while significantly reducing waste streams for our customers. These improvements are game changers for our industry.

We're also excited to bring long-read capabilities to market through two upcoming products in our Illumina Complete Long-Reads offering. Our long-read human whole genome assay will be available in the first half of this year, while the enrichment panel will be available in the second half of this year. We recently announced that our enrichment panel will enable a comprehensive high-accuracy, long-read view for as low as $600 per genome. More than a dozen customers have evaluated data from their own samples using Illumina Complete Long-Reads and their feedback has been strongly positive. They find Illumina complete long-reads more convenient than other long-read technologies and more straightforward with flexible input requirements. They are impressed with the data accuracy, along with the read lines [Phonetic] and phase blocks that can be generated on Illumina sequencers. Illumina Complete Long-Reads and NovaSeq X will continue to evolve the genomics industry.

This year we will celebrate Illumina's 25th anniversary. Over this quarter century, Illumina has remained at the forefront of a global genomics movement, and we're even more optimistic about the road ahead. We're honored to be driving a global health transformation with our customers. And together, we will seize the potential of the genome era. I'll now invite the operator to open up the line for Q&A. Thank you.

Questions and Answers

[Operator]

Thank you. [Operator Instructions] And we'll go ahead and take our first question from Puneet Souda with SVB Securities. Please go ahead.

[Puneet Souda, Analyst at SVB Securities]

Yeah, hi, Francis, Joydeep. Thanks for taking the questions and congrats on the permanent role, Joydeep. So my first question is at AGBT, we saw that you had 150 orders as of this morning, and that's ten more than what you had at the start of this year. So I just wanted to clarify sort of the number increase was only ten versus what are the advanced pipeline prospects, maybe if you can provide that number. Again, I appreciate that you're providing the full year 300-plus number but last time, advanced pipeline prospects, I believe were 200-plus so if you could clarify how much that increased by because the number increase here within a month was somewhat lower than what we had expected. And then I just wanted to clarify, Francis, on, what are you hearing from customers in those advanced pipeline prospects? What are they looking for at this point? How is -- what are they waiting for in order to convert their interest into orders? Are they looking for validation for customers, data or anything else? That would be super helpful. Thank you.

[Francis deSouza, President and Chief Executive Officer at Illumina]

Sure, thanks, Puneet. So let me start with the numbers, as you asked. So as we said, the customer demand for the X Series has been very strong, exceeding our expectation. And you know that we recently shared, as you pointed out, that we had 340 instruments spoken for, between 140 in preorders and 200 in advanced pipeline. Now this momentum continued over the last few weeks in January, and we're currently at over 155 instruments in preorders and over 250 in advanced pipeline. So you've seen the progression as we work through January. Now going forward, we plan to update you quarterly as usual, both on how we're doing with orders, but now as we've started shipping, obviously we'll update you on shipments as well. What we're hearing from customers as we go through the pipeline is that they're incredibly excited about some of the things we expected them to be excited about. So they're excited about the power of the X Series in terms of being able to run much -- many more samples concurrently than they could before. They're very excited about the economics associated with running the X. And they're equally excited about the sustainability features that we put into the X, so the reduction in plastic and waste but also the elimination of the need for dry ice as part of the shipping. All of these combined with the ease of use that they're seeing, so when we describe the specs to them at IGF, they got a sense of the power and the performance and the faster turnaround time. But one of the things that people have been I think, pleasantly surprised about is they get to interact with the X is the investments we've made around ease of use of the workflow. So this is even a significant step forward than the state-of-the-art with the 6000 before. And what that opens up is the ability for the sequencers to be used by a technical team that is not as --doesn't necessarily require a degree in genomics, for example. And so that opens up workforce capabilities for them. Now what we're hearing from research customers is increasingly -- they're starting to see the X as a must-have in terms of being able to remain competitive for grants and grant dollars. And so we're starting to see people cost that into thinking about how they will apply for grants.

On the clinical side what we're hearing is that because of the superior workflow performance and cost associated with the X, clinical customers are designing their new assays and their new tests on the X or the anticipation that that's how they'll roll out new testing. At the same time, they're starting to want to get familiar with the workflow so that they can plan a transition over on their existing tests. So that will take longer. So the first demand from clinical customers is about new testing that they want to do on the X. So that's some of the feedback we're getting from our customers.

[Joydeep Goswami, Chief Strategy & Corporate Development Officer at Illumina]

Yeah, and maybe, Puneet -- thank you, first of all, for your kind words there. I think the other question you asked is what are customers waiting to convert from the funnel to the orders, right? And this is -- remember, this is late-stage funnel so we have confirmed interest. They like what they see, as Francis mentioned, and they have line of sight to budget, right? So usually it's the -- when are they going to get the budget? Maybe it's finishing up or confirming some of the grants, which then tips them over into orders. And we fully expect that as we have seen in other years to happen as we go through the year.

[Operator]

And we'll go-ahead and move on to our next question from Dan Brennan with Cowen. Please go ahead.

[Daniel Brennan, Analyst at Cowen]

Great, thanks. Thanks for taking the questions. Joydeep, congrats. Maybe first on the guidance. I believe at JPMorgan, you guys talked about the '23 guide reflected a conservative approach. I'm just wondering, just given the history in the back half of '22, have you learned anything? Has the process changed in terms of how you're guiding? Could you just walk through a little bit about the conservatism or however you want to quantify it, that's within the '23 guide? I know Francis, you guys quantified a fair number of kind of headwinds. Just wondering how much maybe you baked in cumulatively for those headwinds or however you would kind of discuss the process and the conservatism. And then Joydeep, just on GRAIL. Would love an update assuming that the EC directive comes back here during Q1. I know you guys are going to apply for a stay, but I'm just -- if you can kind of walk us through the process as you see it. If you don't get a stay, then kind of what happens? And related to that, the GRAIL balance sheet. Just wondering, ultimately if GRAIL has to be divested, how do we think about the capital that Illumina has to commit to that? Thank you.

[Joydeep Goswami, Chief Strategy & Corporate Development Officer at Illumina]

Yeah, Dan. First of all, thank you. So in terms of '23 guidance, we have, as we mentioned earlier, pulled in a few things that were visible, of course, is one, the transition to NovaSeq X. We have mentioned that this is -- demand is going to outstrip supply. And we've also told you about linearity that we do expect the second half to be -- for revenue to step up in each quarter as the NovaSeq X gets out to market and people start bringing up the instrument and ordering NovaSeq X consumables. We also expect that -- we placed a large number of mid-throughput instruments late in 2022 and continue to expect to place additional NextSeq 1K, 2K instruments in -- throughout '23. So as those come online, then you would expect an increase in the consumables ramp up as we get through the year. Also in 2023, we have talked a little bit about the recovery in China in the second half of the year. So we had seen China going into the end of '22 and then even the first quarter of 2023 with some COVID hangover or rollover from last year. So right now we believe that those should abate. And we also have a lower impact of FX from first half from -- obviously, from first half into second half of the year. So for all those reasons, we do expect even after taking into account some of the slowdown in recruitment that we have seen in large pop-gen projects, that we will see linearity and revenue step up throughout 2023. And I'll hand it over to Francis for the second part of the question.

[Francis deSouza, President and Chief Executive Officer at Illumina]

Sure. So Dan, in terms of the GRAIL process, we are expecting the divestiture order to come out at the end of Q1, so maybe beginning of Q2. And we are going to apply, if there isn't a stay associated with it pending the appeals, we're going to ask for one. And then we're going to pursue the dual track and going to be pragmatic as we go down both paths. On the one hand, we're going to have a divestiture track where we work with the European Commission GRAIL and go down the path to -- on the divestiture sort of process. And we expect that to play out over the course of this year going into next year. And in parallel, we have our appeals. And we have two appeals underway. One is around the jurisdiction, and we expect a decision probably towards the end of this year and another one is on the prohibition order, and we expect a decision maybe towards the end of this year, maybe sometime into next year. And so those are the two paths.

In terms of the capitalization, part of the divestiture track is going to be around making sure that GRAIL is capitalized going forward. And that could be through a combination of strategic partners that invest in GRAIL. That could be a path. It could be a multistep path that includes initially investment into GRAIL from strategic partners heading towards an IPO. But all of that is dependent on what comes out in the divestiture order, and that's something we're still in conversations with. So we'll keep you updated as that makes progress.

[Operator]

Our next question comes from Dan Arias with Stifel, Please go ahead.

[Dan Arias, Analyst at Stifel Nicolaus]

Good afternoon guys, thanks for the questions. I wanted to touch on GRAIL too, if I may. Joydeep, on the dilution for 2023, the $670 million, I'm just curious how much flexibility you have to work with in that number and the investment associated with that number. Just with the point being that, obviously, the forecast for Galleri is tough to call at this stage in the game. So to the extent that the revenue picture were to start to look different down the road, I'm wondering how much of what you might have to spend there might be variable in one way or another. And then Francis, on the GRAIL NHS project and part one of that study, the 140,000 asymptomatic population assessment. The documents from the NHS, if I remember correctly, stated that the initial results were expected to be available in late 2023. Is that still the timeline we should be thinking about? I mean, I'm just -- I'm thinking about your comment on potential IPO and just outcomes there and what might be important to that process. Thanks.

[Joydeep Goswami, Chief Strategy & Corporate Development Officer at Illumina]

All right. Hey, Dan, thanks for the question. So in terms of the GRAIL dilution of about $670 million this year, a couple of points there. So a lot of that is going towards continuing to accelerate some of the clinical trials in advance of completion of the NHS trials, the submission to the FDA for the Galleri products, and of course to ramp up the sales and marketing that is required as the product continues its successful commercial launch, right? They've had a really successful commercial launch. The way we have projected revenues into next year and based on -- it's really based on the run rate that we have seen with Galleri as they have exited 2023 -- 2022 and some of what they had in the funnel into 2023 and certain assumptions of repeat testing around that. So given that, I will point out, and again, I will say that GRAIL is held separate, so Illumina and Francis and I don't really control their -- how they spend their money and how they operate the company. But I will point out that in 2022, they have been very good with how they've managed to adjust operating expenses as revenues have been different from what their -- some of their original expectations were. So we have faith in GRAIL's management that they are -- they're good managers, they're good with how they allocate their money into the right places that really prioritize the clinical trials and the commercialization of the product.

[Francis deSouza, President and Chief Executive Officer at Illumina]

And then Dan, I'll respond about the NHS contracts. As you pointed out, the GRAIL team has a contract with the NHS that covers the 140,000-person clinical trial that is underway but also covers the next phase pending performance of the trial. And so they've already got an agreement with the NHS that if the trial meets its performance criteria that the NHS will roll this test out to 1 million participants in the UK over 2024 and 2025, and that will be paid for by the NHS. The time frame for that readout is the end of this year, maybe the beginning of next year. So it's still the time frame that was contemplated in the contract.

[Operator]

And we'll move on to our next question with Vijay Kumar with Evercore ISI. Please go ahead

[Vijay Kumar, Analyst at Evercore ISI]

Hey guys, thanks for taking my question, and I had a three-part question here. Francis, one on revenues. If you look at Q1, I think the implied guidance, teens declines. So I think the back half implied is north of 20% year-on-year revenue growth to hit the high singles to low doubles for the annual. What gives you that back half ramp here when I look at this on a year-on-year basis? I know you mentioned the historical launch year as a comp, but can you just walk us through on the visibility you have on those numbers? And Joydeep, one on margins here for you. Why did gross margin decline sequentially Q-on-Q when I look at Q4 versus Q3? And if you start in Q1 at 17% op margins for Core Illumina, is the implied exit rate for Core Illumina in the high 20s when we look at Q4 '23?

[Joydeep Goswami, Chief Strategy & Corporate Development Officer at Illumina]

Listen, let me start and I'll give you some piece in terms of back half ramp on revenues, right? So let me start with the first half -- the first quarter and first half, right? We had very strong quarters in 2021 for the first half. We had record shipments of NovaSeq 6000s, if you remember, at the beginning of the year, still ramping COVID surveillance revenues. So this year, because in Q1 we are -- we've said we're going to ship about 40 to 50 NovaSeq Xs, which is far short of what our demand is for that. You would expect that the first half of the year growth rates are constrained as we ramp up NovaSeq X and we ramp up consumables purchases related to that. In the second half of the year, the story kind of flips a little bit. So you have much more kind of full -- approaching full throttle of NovaSeq X shipments. You have the incremental benefit of people bringing on NovaSeq X consumables. You also have some of the effects which were headwinds this year in terms of China COVID, in terms of overall COVID surveillance going down in the back half of the year. So you're right, the percentage growth rates in the latter part of the year and the actual revenue both start to step up in the second part of the year. So hopefully, that part is clear.

In terms of margins, so let me talk about gross margin first. Gross margin declines quarter-over-quarter and, of course, this being a launch year, primarily due to the impact of -- especially if you look at quarter-on-quarter is really due to the impact of launching NovaSeq X in Q1, which, as we had told you, would start off this year with a lower margin. We expect that margin to continue to improve as we go into the latter part of 2023, as we have much more utilization of the factories and of course we start squeezing out efficiencies in the process as is normal. And I think the same thing with operating margin. I think your question there was, you start off with a fairly low operating margin. For us, it's -- as both gross margin and the revenue profile improves, operating margin should improve as we go into the second half of the year. And that's mostly just math in terms of much better revenue profile to cover operating expense, which remains relatively flat as we go through the year. So hopefully, that helps you understand a little bit of how we've thought through the year.

[Operator]

And our next question comes from Tejas Savant with Morgan Stanley. Please go ahead.

[Tejas Savant, Analyst at Morgan Stanley]

Hey guys, good evening and thanks for the time here. So two-parter here. First on GRAIL, Francis, just going back to Dan's question there. Can you talk a little bit about how much of that $670 million in opex this year is specifically related to that NHS clinical trial that presumably drops out starting in '24? And is there the possibility of a delay or a period of evaluation as the results come in from that before that 1 million paid pilot launches? And then second on NovaSeq X pull-through assumptions, if I look back to the 6000 launch, you guys were approaching almost $1 million in pull-through about six quarters into the launch. So is there any reason why you couldn't sort of easily exceed that, say, six quarters into the X launch or the back half of '24, should that number be sort of 1.3 million, 1.4 million-plus. Is that fair?

[Francis deSouza, President and Chief Executive Officer at Illumina]

So thanks for the question, Tejas. Let me take some and then Joydeep will chime in if he has anything to add. So let me start with the GRAIL question and around how much of that $670 million is associated with the NHS trial. And is there a chance that the readout is delayed or the next phase is delayed? So a portion of it is, so we haven't actually broken out that $670 million. A portion of it is but it's not the majority of it. So there are a number of things going on at GRAIL. In addition to the NHS trial, there is also the studies they're doing for the FDA submission, and they are looking to have the final submission done towards the end of next year. And so they're sort of in the thick of things with the FDA. However, there is the part associated with that NHS trial. And as you point out, that moves from being a pure cost to GRAIL right now for this 140,000-person trial to next year being a paid rollout starting next year over two years to 1 million people. So a pretty significant shift in economics positively for GRAIL next year.

In terms of the time frame, the NHS did a very thorough sort of diligent job with GRAIL in terms of planning out this trial. And because GRAIL has done so many studies of such significant size before, they really had a good handle on how to analyze the data coming in and sort of what you would need to get to the decision that they're looking for. And so we don't expect and we haven't seen at this point any delays associated with the analysis that's happening of the data. And so we fully expect them to be getting to that readout at the end of this year, beginning of next year. And then similarly, because of the power of this test and the NHS being so keen to really use this test as a core component in their war on cancer, their intent is to get through the readout as responsibly and quickly as possible, and once the demonstration meets the performance criteria, to get to that rollout as quickly as possible. And so there's a huge motivation on the side of the NHS again because of the potential life-saving benefits of this test. And obviously, there's motivation on the GRAIL side too. And so I don't expect there to be any delays that pop up between the readout and then rolling out the test.

In terms of the 6000 pull-through then, what we have said and you've seen this before, is really we expect some time likely between the first and second year for us to get to a stable point in terms of pull-through. And you pointed that out that we got there on the 6000 in that kind of time frame. And so one, we do expect that to be the time frame and we'll keep you updated as we work through the process. And as you know, but for everyone else, before that, the numbers are still too volatile for it to be a useful modeling metric because as you put out a whole bunch of new instruments and people start to ramp up, the pull-through can move pretty significantly from one week to the next, one quarter to the next. And so it takes that year for you to get enough instruments out there for the number to be significant. Now also as you pointed out, as we get to a stable number for the X, we feel really confident that the ultimate pull-through number on the X will be comfortably above what we had with the 6000 because of the power of the X and the quick turnaround time and the ability to run just so much more on an X over a year.

[Operator]

And we'll go ahead and move on to our next question with Sung Ji Nam with Scotiabank. Please go ahead.

[Sung Ji Nam, Analyst at Scotiabank]

Hi, thanks for taking the question. Another one on GRAIL. Would love to get your thoughts, Francis, in terms of you talked about the FDA Breakthrough Designation for the Galleri test. Kind of -- I know it's still kind of an uncharted territory to get it going through the FDA process and also maybe gaining broader reimbursement from Medicare. So could you kind of talk about kind of what efforts are being made in order to move forward with those in that direction.

[Francis deSouza, President and Chief Executive Officer at Illumina]

Yeah, sure. So let me talk about a few things. One, as you pointed out, GRAIL has been able to get Breakthrough Designation from the FDA, and they have been working now with the FDA for a number of years on designing the studies that will be part of the ultimate submission. And so they've been working collaboratively with the FDA. And although -- they've been working with them, they've already submitted some of the modules associated with the FDA submission, and they are planning to do the final module submission at the end of next year, maybe extending into the beginning of the year after. So they're making good progress.

The other big step with the FDA which really breaks new ground is that they've been talking to the FDA about submitting data from the NHS trial as part of the FDA submission. Now that's really powerful because that's a very large trial. And so that continues to add to the bolus of evidence that GRAIL was able to get and submit into the FDA. And so I think it's -- we're starting to see the benefits of that good working relationship between GRAIL and the FDA. And as you know, when you have the FDA approval, that's a pretty significant step forward in terms of getting broad reimbursement in the United States, which is a really, really big value creation point from a GRAIL perspective. So you'll see both things play out in the next couple of years. You'll see the big NHS move from going from a trial to a rollout, a population rollout starting with the 1 million people and then going population-wide after the 1 million people rollout in the first two years. And at the same time, you'll see the progress in the U.S. with the final FDA submission at the end of next year and then the path towards broad reimbursement in the U.S.

[Operator]

We'll go ahead and hear from David Westenberg with Piper Sandler. Please go ahead.

[David Westenberg, Analyst at Piper Sandler Companies]

Hi, thank you for taking the question and congrats again to Joydeep. So two, I'll just ask upfront. Many of the lab companies that we cover are talking about reduced cash burn, and they're really excited about NovaSeq X and how even some of them are kind of excited about going from NovaSeq from NextSeq. So can you help us reconcile their desire to reduce cash burn and your expectation of increased spend with you? And then just my second one is just continuing on some of the price stuff. Why should we not be concerned about the new $99 Complete Genome -- Complete Genomics thing today? Okay, thank you.

[Francis deSouza, President and Chief Executive Officer at Illumina]

Thank you for the question, Dave, so let me go through them in order. So first, we're hearing just like you're hearing from lab companies that are really excited about the -- again, it's the power, the performance, the turnaround time but also the economics associated with the X. And I talked about the fact that increasingly people are going to see those economics as table stakes for applying for and winning new grants. But for lab companies, too, especially in this environment, as they are looking to squeeze the most out of their operations, they see the X as a path to get there, and the superior economics will help them as they lower cash burn and reduce their capital needs going forward. And so we fully expect that to be part of the conversation with our customers. Similarly, we're seeing that on the NextSeq side, right? So we're seeing customers that are seeing more demand come in. And the question for them is do they buy the next NextSeq or do they fundamentally transform their cost structure and move to the X? And that's part of the reason why we're seeing a higher-than-expected demand from two segments: one, from the clinical segment, and we talked about the preorders coming in represent a higher percentage of clinical customers than we expected; and two, from new to Illumina and new to high-throughput customers. And so that dynamic is already showing up in the preorder number.

In terms of the competitive dynamics, one of the things that we're really excited about is that when we talk to customers, they get very quickly that when they're comparing what system to buy, they really look at -- they need to look at the total cost of ownership in terms of running these sequencers. And that's one of the unique things about the Illumina portfolio around that started with the NextSeq 1K, 2K but now with the NovaSeq X is that we have built in capabilities like the compute associated with the primary, secondary and in some cases, even parts of the tertiary pipelines that are baked into and built into the instrument, that we've built into the instrument capabilities like lossless data compression. And so when they start to compare prices, it's not just the cost of sequencing that they need to look at but it's also the associated compute costs, the storage costs that they would need if they had any other sequencer in the market. And one of the things that I talked about when we talk about the X is that just the compute savings you get associated with the NovaSeq X will save you over $1 million over a four-year, five-year period. And so that's really exciting for them. Forget about the real estate requirements, forget about the time it would take to post process your data, all of those are important, but they also see that the total cost of ownership of the X is so much superior because of those built-in capabilities.

[Joydeep Goswami, Chief Strategy & Corporate Development Officer at Illumina]

Yeah, I mean, Francis, just to dovetail on that, right, David, you had asked about, yes, there are cash constraints with people trying to reduce cash burn. But it's important to understand that, A, sequencing is at the very heart of the value that these companies are generating and even academic institutions are generating, right? So they want to do more sequencing because sequencing gives them answers that other technologies are not giving them and at scale. I think the second point that Francis mentioned is really important, right, that when they look at their cash burn, something like the X or NextSeq 1K, 2K actually allows them to reduce their expenditure elsewhere, like things as storage or compute or other things, right, and allows them to redirect their investments more positively into areas that add value. And that's a really important point as you think through. And then the third thing is just what they're doing in elasticity, demand elasticity or new applications that Francis and Susan and others have pointed out earlier, which is moving to things that they have not done with the NovaSeq 6000s or any other instruments before, which really then pulls through the elasticity that we are expecting to see starting in 2023 but really picking up in 2024 and beyond as the Xs become fully entrenched.

[Operator]

That is all the time we have for a question-and-answer session. I would now like to turn the call-back over to Salli Schwartz for any additional or closing remarks.

[Salli Schwartz, Vice-President of Investor Relations at Illumina]

Well, thank you for joining us today. As a reminder, a replay of this call will be available in the Investors section of our website. This concludes our call and we look forward to seeing you at upcoming conferences and other events.

[Operator]

[Operator Closing Remarks]

Participants

Corporate Executives

• Salli Schwartz, Vice-President of Investor Relations
• Francis deSouza, President and Chief Executive Officer
• Joydeep Goswami, Chief Strategy & Corporate Development Officer

Analysts

• Puneet Souda, SVB Securities
• Daniel Brennan, Cowen Inc
• Dan Arias, Stifel Nicolaus
• Vijay Kumar, Evercore ISI
• Tejas Savant, Morgan Stanley
• Sung Ji Nam, Scotiabank
• David Westenberg, Piper Sandler Companies