Illumina, Inc. (ILMN) Earnings Call Transcript & Summary

All right. Good morning, everybody. I'm Doug Schenkel. I'm the lead analyst for the tools diagnostics and labs effort here at Wolfe Research. Thanks for being here today and listening in on the web. It's my pleasure to welcome Ankur Dhingra, the CFO of Illumina; and also, Salli Schwartz. So really appreciate you both being here. Just to give everybody an agenda, we have a lot to cover for the next half an hour or so. I thought we would start with kind of what we've been starting with the last day, 2 days, talk about the other state of the union, the state of the state for Illumina. Of course, given developments last week, it would be good just to talk about how you were thinking about election implications 6 days after or 7 days after the election, totally fair question, I think. So hopefully, I'll have all the answers. And then get back to the core, what's going on, especially in the clinical end market as things transition there, maybe do a little bit of just probably more for me than anybody else, but Q3 cleanup and then maybe talk a little bit about how you're thinking about 2025 and the longer-term outlook. So I think that's the road map. Again, thank you both for being here.

Very happy to be here.

Ankur, I think you joined Illumina, I think it's about 7 months ago now. If I were to summarize the challenge and the opportunity, you're tasked with -- together with the team, helping restore revenue growth, enhancing operating discipline and taking the opportunity while you're generating robust free cash flow to deploy capital and optimize not just above the operating line, but below the operating line. So with that said, 7 months in, where do you think you and the team are in terms of identifying opportunities pursuant to this mandate?

Yes. I would -- so thanks, great question and the right timing as well. So I appreciate that. Overall, where I stand today, if I look back and when I started in April, I'm very pleased with the progress that we are making. As a company, we are in transformation and the progress that we have gained, continue to make transition. I'm pleased with the number of steps we have taken. Most of you or many of you now know, in August, we taken the ground about the strategy that we have, both for the top line returning the company back towards high single-digit growth as well as improving the operating as well as the earnings power of the company over the next few years. In the last 7 months, we've also taken the decisive action of divesting GRAIL and have kept a small portion of it, but essentially, GRAIL is now completely divested from Illumina. The work that we've started as part of the transformation, if I parse that out into 2 main chunks and they will touch below the line and the cash side of it. On the growth side, we laid out a strategy of returning to high single-digit growth. And the largest component of that are the 3 total factors was around returning the core consumables and instrumentation business back to growth. A lot of that is premised on our high throughput business, which is where Illumina's largest strength and the position in the market is. And that transition, as we've laid out in our Q3 results as well, has been going quite well. We kind of expect that by the time we get into the second half of 2025, a major part of that transition is to be complete with most of our customers and the volume being on X. And we made significant progress on that during Q3 as well. Additional layers of growth on top of retaining the growth come from multiomics, and we've made significant progress. I'll touch on that a little bit more. And then the last factor is around services and data strategies, which we've said we have Illumina as a company has had several smaller businesses around the services side that have historically been managed more like programs rather than setting them up formally as a business with defined portfolios, people who know how to define and scale those businesses. And our near-term focus there is to build management and team capabilities as well as portfolio capability in that area, and we have made good progress. We've hired a leader for that business now. They've also started building the team underneath and specific pieces around data and AI strategy are now being formed at this point in time. And so that last portion likely will have smallest contribution in returning to high single-digit growth during the 3-year period. A little more -- is this okay? All right. So that will have the smallest portion. On the multiomic side and returning overall core business to growth, one of the fundamental transformational steps we are taking is how we work with our customers. And a lot of our customers, and you've seen the change that we've now driven starting in August, where we opened up a good part of our pipeline and have started giving early access to a lot of our key customers, so that not only can Illumina get feedback from the customers well before we commercially launch the product and give folks something which is both technologically and workflow-wise works well for the customer ecosystem, but at the same time, specifically for our clinical customers who have to make technology choices well in advance of launching a clinical test, they can take advantage of the newer technology capabilities that Illumina has been working on. That part of the transformation, I'm very pleased about. Some of the early results we've seen, the early comments that we're hearing from our customers are phenomenal. As I've now gone ahead and met several customers in their labs as well as had core lab directors come into our offices. And many of them said they haven't had a meeting of this kind with Illumina ever before. And having that line of sight towards what's coming, we see tremendous amount of interest there. On the multiomics side, we've talked about the acquisition we've made of Fluent, single-cell technology. We talked about the partnership we've made with -- on the Protein Prep side. So those two are already getting -- becoming part of the portfolio. And on the core side, we're very excited about some of the changes that we're making on the backbone genome, we're calling the constellation map, that also, if you've seen the recent data that was presented by Neil at ASHG, this tremendous potential there, too. So in short, good progress, not anywhere near done that -- done, transformations take time. Improving cultures take time, but both Jacob and I are heavily focused on that. Moving to the bottom line. Again, a lot of the early work. Some of it was started before me, but during the last 6 to 7 months, we've made an additional push towards reprioritizing our investments as well as a significant amount of discipline around where we spend our money. We've launched several programs around structurally changing the cost structure of the company, whether on the manufacturing side or on the G&A and international capability side of things that we think over the next 2 to 3 years, incrementally we'll keep improving our cost structure and deliver the operating margin expansion that we've talked about. So I feel good about the cost side. On the top line side is where we will continue to work through this transformation, both transition of our X platform as well as launching the new technologies from our pipeline. Now the last part is from the earnings. Obviously, we have a very strong cash earnings power. Our cash conversion is significantly stronger than anybody else in the tools. And we have now strategies that we are now getting to put in place, having very clearly defined M&A strategy, having very clearly defined targets that we think would make sense for them to be part of the Illumina portfolio and have started kind of executing on it. Fluent is a good example to think about. But at the same time, we're working through delivering, also working through some of the share repurchases, but have sufficient cash power to continue to do some sort of tech and M&A there.

Okay. Super helpful, good overview. We'll unpack more of that as we get into some of the other topics here. Just very quickly on the election. I think there's actually really 3 topics that have come up a lot that relate specifically to Illumina. So one is the outlook for NIH funding, two is China as it relates really to local competition, which is not really something new for you. It may be new for others. So maybe the silver lining is you've maybe already taken your lumps there. And then the third is really how we think about tariffs, both in terms of China and globally. So what do you do in China? How much is China for China? And then from a sourcing standpoint, how should we think about tariff exposure for Illumina?

So I'll start with the -- let's cover them in that sequence. So at the highest level, up to C, the way we think about it is historically, we have seen a good bipartisan support for use of genomics in research, whether you think about the food agriculture side of things or broader health care side of things. And traditionally, there have been pretty positive support there. We are connected to both sides of the aisle in the government to keep an eye on really what's happening, what gets written in the policy as a paper because it is eventually what that matters. So we're staying close to that to see what kind of decisions get made, what eventually does go into the policy and whether we are able to respond to that and what plans would we have. The -- if you look at historically, so in 2016, when the same administration was there in those years, NIH funding actually grew those 3 to 4 years. So that's one real data point of -- there is a lot of political and geopolitical negotiations that happen. What eventually still matters is what gets written in the policy. And the only data point we have last time was that it actually grew. Now, we're not sitting here and anticipating that it will grow again the next time. One of the other factors that we've seen typically so far is if NIH funding still holds, if it doesn't grow and holds flat, so far, the usage of genomics and the grants for genomics have typically tended to hold well. The amount of money that goes towards genomics has typically been growing. And whether you go towards oncology research or broader health care research, the grants towards genomics have held up pretty well. And last but not the least, just in terms of -- based on the data that we've shared publicly, if you think about the size of our business, half of our business is in the U.S., as you know, and half of our business is in research. You're talking about a portion of 25% of our business that is in some ways exposed to government funding. The piece that is directly we know comes from NIH or our business with the government is really small. So it's more a factor of the grants that our customers are getting to be able to run the research, and that's a portion of that 25%. We don't have visibility to all of that, but we do support our customers in writing their applications for the purpose of the grant, what kind of outcomes they can anticipate. And we feel some of the strategies that we have around library prep is a lot of the research dollars have been going towards single cell. A lot of research dollars are being used in protein-based analysis as well. And to the extent we can continue to simplify the workflow and take the overall cost of workflow down, our ability to support our customers in seeking planned dollars continues to improve as well. So there are actions we can take. But in the end, if NIH dollars get cut, there will be an impact to our business, hard for us to quantify exactly what that size is going to be. But there are levers we can pull in terms of helping our customers to still be able to write better grant applications, take advantage of the overall workflow that Illumina can provide and be able to support their efforts. That's how kind of thinking about it.

Can I really just paraphrase real quick? So mathematically, total U.S. academic exposure is about 1/4 of the business, direct exposure with...

That's research.

That's total research, not NIH?

Not just academic, not NIH, that's total research.

And our work, not Illumina's. I'm sure yours is better, but over the years, we have looked at typically government-funded research, not just NIH, NSF, Department of Energy tends to be half-ish of that and then direct NIH exposure tends to be kind of low single digits. So it sounds like, again, not blessing numbers, but logically, I'm doing okay math.

Yes, you're probably not too far off.

Yes. And then typically, what we've seen looking back decades is you haven't seen massive cuts in NIH really ever, including in the last Trump administration, where they actually grew above average. But typically, when you have seen slower periods of NIH growth, the trailing amount of funding that comes from endowment industry tends to kick in and create stabilization. Is that consistent with how you think about it?

That is true as well. The number of research grants being provided by the private foundations and endowments has remained pretty robust overall.

All right. Super helpful just for us to have frameworks as we hear different things heading into confirmation hearings, different quotes. So super helpful. Sorry to interrupt. China?

China. Okay. So China, again, geopolitical and competitive environment there. So just from a framing perspective, China has always been the country where we've had largest amount of competition. It is also the country where we have the lowest market share as well over a period of time coming from BGI, MGI, as well as now of late some of the smaller, newer entrants in sequencing as well. We do see that over the last 2 to 3 years, our business in China has shrunk quite a bit. But the change in trend that we've seen in the last 2 to 3 quarters is that it has started stabilizing at that $75 million a quarter kind of mark, so maybe, say, call it, $300 million a year business. Just 2 to 3 quarters, I can't call it a trend yet, can't even call that it's going to return to growth at any time soon. But the environment within China, we see 2 distinct dynamics for us. One of them, there is increasing local competition, but a lot of that competition is amongst the Chinese companies, odd market share, the customers who've been -- who buy Illumina are still customers who buy Illumina. We're seeing lesser competition from the smaller players to us, but we do see that the MGI, BGI are seeing increased competition from some of the other players in that market. So competitive intensity in China remains very strong as it has always been. From our access to the market perspective or our ability and how we play there, we actually see some positive improvements in that space. So as we've said before, we've hired a new leader in China. Jenny has now been there about 5 to 6 months as well. She's started making some structural changes, both in how we and our commercial team is organized in China as well as how we work and the relationships we have with the regulators. The regulator side, in fact, on the ground, if you think about the last 2, 3 months or so has actually improved slightly. We have seen Chinese government coming -- we've seen a little bit more positive inputs from the Chinese government for Illumina in terms of the -- our ability to sell directly to the hospitals. There are tenders or more tenders that we're now allowed to participate in than we have been in the past. There are also discussions about our ability to operate out of certain free trade zones that we weren't allowed in the past. So within health care, we've seen small incremental steps, which are actually positive than the overall macro commentary that you would hear. Now a lot of these things take a while before you start seeing real business impact in terms of our ability to resolve there. So our aim and the way we are operating there is still increase our presence to sell more directly into some of the channels that are opening up for us, increase our relationship, both on the regulatory side as well as on the -- directly with our hospitals and the clinical side of China, and then go from there. There's a lot of steps we can still do there, as a country use of genomics strategically, China is and continues to be one of the leading nations on how genomics is being applied from a clinical use within the country, both from a drug development perspective as well as utilization in the hospital perspective. They want access to the leading technologies in the world. They do want to apply the leading technologies in the world, and we intend to remain invested and keep working with that nation.

Again, just to frame it, I think it's about 7% of sales as we sit here today, down 25% year-over-year thus far. But actually, in dollar terms, kind of moving sideways around $75 million per quarter and based on what we know let's see what happens with the geopolitical and the government. But in terms of what you can control, we're at least in a period where you feel things have stabilized. Okay. Tariffs?

Okay. So tariffs. The -- our overall manufacturing setup is fairly global. There is a pretty sizable chunk of our instrument manufacturing and part of the consumables manufacturing that is still done in the U.S. We have 3 factories in the U.S. The second largest manufacturing setup outside of the U.S. is in Singapore. When we look at our supply chains, our exposure outside of the U.S. is largest in that Singapore, Taiwan area. We barely, a very small portion of our manufacturing sites in China and whatever is in China is for China to the extent it is. We are in the process of doing a layer 2, layer 3 deep dive within our supply chain to say, are there components and subcomponents where suppliers are sitting in China and kind of working through all of our alternative plans to say, in case there is a tariff impact, what alternative sources of supply could exist outside of China and working towards qualifying those suppliers, right? So in aggregate, it's not a very large exposure for us from a tariffs perspective. However, depending on really what gets written in the policy, given that we have manufacturing in the U.S. and Singapore, we may have levers to be able to shift and move things around as needed depending on the size of decisions that come out of the government.

All right. I'm going to pivot to Q3 and really focus on the clinical end market where I think there's a lot of focus.

Clinical cliff.

Yes. So maybe I can just -- and hopefully, I wrote these numbers down right, and please correct me if I'm wrong. I think on the Q3 call, you said high throughput and mid-throughput sequencing activity, I think, was the term you used, grew 40% year-over-year. So recognizing it's our model, not yours, and that means it's going to be off in spots. But what we have in the model is we have high throughput, mid-throughput consumable revenue growing 5% in the third quarter, high throughput being higher than mid-throughput. But regardless, even if I'm off by half like let's say it's 10% growth, there's a big delta between 40% and 5% or 10% revenue growth. What's the delta?

Largely price. Largely price. I think there was a question during the earnings call, and we said the price decline during the quarter was towards the north higher end of the range that we've provided, that gets it closer to about, say, 25% decline on the price.

So in the context of -- I think most of us believe there is going to be growth in activity, especially in the clinical end market. The concern or the focus or the controversy, whatever you want to call it, is where are you in getting to the other side of the pricing headwind. When we hear 40% or 30%-ish pricing hit in the quarter, should we be freaked out or should we be encouraged that you're further along in the curve than maybe we would think?

I'll tell you, I was pleased where it landed. To me, that was a proof point that in a quarter where we saw acceleration of transition from 6000 to X, we're almost a little over 10% of our volume moved from 6000 to X and high throughput. We could still have our consumables grow at the pace that which we reported, right? To me, that was a confidence in the model that even if we see a steep move in a particular quarter, till the time the overall sequencing activity holds, we will see a good flow-through to our revenue. I was pleased with that. The way I'm tracking at it is still at the aggregate level to say, by second half of 2025. If by that time, we can get more than 75% of the volume moved over to X, we will start getting to a point where the price transition is getting largely annualized, right? It is in the denominators and a larger part of our volume growth should start flowing into the revenue and gets us closer and closer towards that high single-digit growth model that we've set for last 3 years. That's how I'm thinking about it.

Yes. And it's -- you guys made it easy because there were a lot of 40s in the quarter. But you said 40% clinical gigabase -- the data, the gigabases of data were generated on the X, I think, in the clinical end market.

That's right. That's right.

So does that tell us like this concern that major customers are going to move over to the X? Does this tell us we're actually maybe a little further along in that?

From my point of view, that's a good spot from a transition perspective, right? The question -- so a lot of our customers do share their plans with us. They -- when they're going through the validation process, they need our help in terms of -- many of them work with us in optimizing their software pipelines to make sure they're still getting the right results, et cetera. And we get a sense of what their transition plans are. Many of them are talking about, as we would expect as part of the transition that's going through to say they'll move one test in Q1, the second test in Q2, they're trying to sequence it over multiple quarters instead of doing everything in one go, et cetera. So we do get that line of sight, especially...

Including from your biggest customers.

Especially from our largest customers, right? They are the ones who we end up hand holding through the transition as well versus a lot of smaller customers, we tend to have a lesser visibility to. We only find out, oh, they just bought X already. So then we kind of think in and say, okay, what are you anticipating? So that's what gives us confidence, right? At a higher level to say the transition is going well, the fact that our largest customers are engaged, taking advantage of the capabilities that we are providing, we also end up having the conversations about the next test they're launching, the kind of validation and the development processes they are going through in their -- either the clinical trials or within the research environment. And we have the discussions about hey, constellation map can add additional value here for the next test that you're launching, how it can aggregate in working with DRAGEN can actually give -- potentially give you even higher specificity than what you're looking for here, et cetera. So the elasticity conversation is almost always part and parcel of the transition discussion as well.

And that's mathematically. I mean, the way I maybe clumsily described it, it's volume plus intensity. And if your data generated is up 40%, if you're only growing 5% to 10%, if the delta is price, your -- we talked about where you are in terms of getting through the pricing headwind curve. But what you're also seeing is evidence of what you just described last like this idea that elasticity is all of a sudden dead, you're getting the volume, but you're actually sequencing deeper and wider, right?

Absolutely. Absolutely. Let me just add a little bit more color to that. The discussions we have with customers irrespective of where the audience transition, many of them are thinking of moving. Some of them, I believe, personally, will never move. They will keep their tests on 6000. They believe -- many of them believe that their resources are better applied towards development of the new test which has a higher revenue potential rather than spending the time on validating and moving an existing test. For example, we have customers who still use MiSeq for their clinical test. They haven't even yes -- they haven't even moved NextSeQ; they haven't ever moved to 6000 either, right? So people have stayed in the technology. There are multiple different reasons when and why they would make their transition discussions there. But more importantly, discussions we are having is around how do you apply a whole genome sequencing base to another test in Oncology or any other disease area. Discussion what we're having is we have enriched our DRAGEN pipelines and the AI model so much that follow those next phases of whole genome based test that they are developing, how Illumina through the library prep as well as the improved software can dramatically reduce the overall cost of the workflow. And that gives us a line of sight towards what new tests are under development. We see a lot of that right? And our customers would never want us to disclose any of that to all of you, so we don't talk about it. But the fundamental concept of elasticity and how our customers are using the technology, at least for the largest ones, we do get a good line of sight towards that.

All right. We only have a couple of minutes left. So I want to talk about 2 things lightening around. I feel better about high throughput, mid-throughput, I would say, as -- looking for improvement there has taken a little longer and I might have expected. I think you're over-indexed to mid-throughput in China. So we've kind of covered a little bit of that, as part of our China discussion, but there is, of course, more intense competition in the West as well. As we sit here today, should we just assume, at least for the next few quarters, that it's in spite of all the things you guys are doing that this is going to remain under pressure for a little bit longer?

Yes. We are not assuming any macro to improve. Now let me just overall framing on mid-throughput side, and you've had a lot of discussions about competition, especially in the U.S. I'll tell you, there has always been competition on mid-throughput, right? A lot of times, we have had to recourse back to an IP-based discussion with some of that competition. In the other cases, it has been more around what the real value that the Illumina brings into the ecosystem. When I look back and analyze that business and what's going on in the mid-throughput, there are 2 main drivers, right? The largest, by far, the largest factor is that the customers, because of the macro issues have been transitioning their sample volume to high throughput. And a lot of our mid-throughput customers who are constrained by that macro environment are resorting to sending their samples to either core labs or other sequencing providers. I come from a diagnostics. I also come from a pharma company. I was in a pharma -- CFO of a pharma company that was generating a genomic biomarker based drug and running a clinical trial. And we were relying on a CRO or send out for some of our own genomic test as well. So that constrained environment is making people take decisions on what are they going to invest in their lab or until money frees up, they're going to take advantage of the lower high throughput pricing that is available externally. I also believe when the capital markets for the funding environment improves, a lot of the pharma companies and the biotechs who are especially focused on genomic biomarker-based drug development, there are good reasons to in-source that lab operation, even if it is at a higher cost of a mid-throughput, the pace at which you can respond on what is going on in your clinical trials, the pace at which you can respond on what additional indications you can go after does improve dramatically. There's a good business reason to keep that in-house, provided the funding environment improves. That has been an important element into mid-throughput as well. So I do think there are additional 2 factors that are coming our way from an Illumina perspective. We have said we will be launching a NovaSeq X slightly lower throughput version of NovaSeq X with a single flow cell, and that is at a price point which is well below $1 million. So there is a potential that some of our mid-throughput customers may see some value there. And also, the higher end of the new MiSeq I100 that we have launched as capabilities that can see into some of the mid-throughput kind of requirements as well. So it's going to get squeezed from a little bit from both the directions as well.

Last one, 2025. I know you're not going to guide here.

Of course not.

But consensus has landed around 4% revenue growth next year and around, again, lots of 4s, [ 4 40 ] in earnings. As we think about kind of the moving parts, I think we feel really good about your handle and the team's handle on the self-help aspects of the story below the revenue line. The question is obviously the revenue trajectory from here, the things we should be aware of, continued high-throughput improvement as you work through the pricing dynamics we've talked about, continued pressure within mid-throughput, but at some point, you get to the other side of that, at least that's the plan with some of the initiatives we just talked about. Potential upside drivers include things like SomaLogic or SomAmers the new MiSeq and Fluent contributions, the risk would really be the uncertainty associated with -- even if there is a pause in the face of uncertainty around the NIH and purchasing new instruments in the difficult environment.

That's good framing.

Are those that -- okay.

That's good framing. Directionally, based on things that we've laid out, that's exactly what is we expect continued transition in the X by the time we get to the second half, as I'm anticipating, we should have a larger part of the volume already transitioned over. The macro at this point, we have no reason to assume that it is going to improve. We're still thinking or call it when it actually happens when you begin to see the results, that's when we'll call it. At this point, there's no reason to do that. And yes, several launches that you've outlined are the ones that we're super excited about.

Okay. All right. We kept -- or I kept everybody over by 3 minutes. I appreciate everybody hanging with and thanks to both of you again.

Absolutely, appreciate it.