Adaptive Biotechnologies Corporation (ADPT)
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Morgan Stanley 21st Annual Global Healthcare Conference 2023

Sep 13, 2023

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Hey, everyone. Good morning, I'm Tejas Savant. I cover life sciences here at Morgan Stanley. Before we begin, for important disclosures, please see the Morgan Stanley Research Disclosure website at morganstanley.com/researchdisclosures. If you have any questions, do reach out to your Morgan Stanley sales rep. It's my pleasure this morning to host Adaptive, and speaking on behalf of the company, we have Chad Robins, CEO, and Tycho Peterson, my old boss, CFO. Thanks for joining us today, guys.

Chad, maybe just to set the stage, can you reflect on the last four years post-IPO in terms of what's gone well relative to your expectations back in 2019, and where progress has perhaps been slower than you'd anticipated in terms of monetizing the value of, you know, what is still, you know, a proprietary and incredibly valuable immune medicine platform?

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Yeah, sure. So first, thanks for having us, Tejas.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Yeah, if you reflect back to the IPO, the MRD business is just moving along really nicely. You know, we're executing, we're operating. Our volume growth is good. We're putting all the right pieces in the right places and feel very, very comfortable. I'm also, you know, quite enthusiastic about our cell therapy deal with Genentech. You know, although it has, albeit, gone a little bit slower than expected, the data so far on the private product is looking really good, and that's moving along well, and excited that we, you know, to announce last quarter that our first IND filing, you know, happened for the shared product. So that's moving along as well. You know, the area, if you kind of reflect back, that you...

was a little bit of a pivot, or a lot of a pivot, in the areas of kind of mapping the immune system, which we're still doing. But in terms of commercializing the diagnostics, we're refocusing that data and effort into target discovery. And we're also using that information as a potential biomarker in kind of future trials, and there's a richness of that data. So, but just in terms of, you asked me to reflect back on the last four years, I think what we've learned about the diagnostic industry, just in terms of the rate of, you know, clinical adoption and the rate of kind of payers implementing payment on diagnostics, has been... It's a challenging environment, and that's why we made the pivot.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it. Makes sense. You know, sort of similar question for you, Tycho. I mean, you've known Adaptive since inception, first from the outside and now, you know, as CFO. In your opinion, I mean, give us a sense for how the company has evolved and matured over the course of that time frame, especially over the last 12 months, and why you think sort of the next five years of Adaptive's journey could look very different from, you know, what happened since 2019.

Tycho Peterson
CFO, Adaptive Biotechnologies

Sure. It's a couple things. You know, I think it's sharper, crisper decision making. So Chad talked about, you know, what we decided around T-Detect. And then I think, you know, importantly, everything we're doing operationally. So, you know, you're starting to see some benefit in gross margins. We've got a lot going on in the lab now.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Tycho Peterson
CFO, Adaptive Biotechnologies

We're doing a lab move, a consolidation.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Tycho Peterson
CFO, Adaptive Biotechnologies

We're doing an evaluation of NovaSeq X.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Tycho Peterson
CFO, Adaptive Biotechnologies

You saw this past quarter, about an 8% sequential increase in our underlying sequencing margins. So we're going to continue to drive, you know, COGS and, and margin improvement.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Tycho Peterson
CFO, Adaptive Biotechnologies

Then the other thing we did when I came on board was shore up the balance sheet. So, you know, we did the $250 million deal with OrbiMed. We've drawn down half of that. We've said that's enough cash to get to profitability. So we're continuing to get more and more efficient every day and really just kind of grow up as a company.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it. Makes sense. Let's start on the MRD side, Chad. So, you know, blood-based testing accounted for, I think, over a third of all MRD tests. It's up, I think, 16% from the first quarter, driven by community accounts. You've put forth, you know, significant efforts to increase penetration in the community setting over the last year or so. Can you describe sort of the factors that were the most important in terms of driving that metric higher?

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Yeah. So first, we doubled the size of the sales force last year, and we, 29 of those reps are focused specifically on the community-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

- and four of those reps are even more targeted to what we'll call kind of super accounts, like Florida Cancer Specialists, Tennessee Oncology, really, really big network practices. And so that's been a big driver of community, which accounts for, you know, 60% of all cancer patients are at least initially treated in the community.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

So in terms of kind of blood-based testing, most community practices much prefer blood-based testing as opposed to the marrow.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

So the increase in the community, what you're getting, you know, by, you know, by default then, is an increase in blood-based testing. But it also, if you look at the expanded indications into DLBCL and CLL, these are, these are indications which are, are blood-based tests.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

And then, you know, finally, a big growth driver in terms of multiple myeloma, we've done a lot of work in kind of blood-based multiple myeloma testing, showing that it is an alternative and an option there as well. So yeah, right now, we're at 37% in terms of blood-based testing. We hope to, you know... We will continue to increase those numbers, as additional indications roll on and as we, as these reps get more productivity, which again, we've been really pleased with the productivity gain, kind of from if you look at sales per rep, it's gone, you know, significantly up in the last year.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it. And in terms of, you know, community accounts, I think they represent north of 20% of clonoSEQ volume now. That's, you know, close to double of where that-

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Yep

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Number was, you know, in, I guess, June of 2022. Could you just share what that trajectory could look like by 2025?

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Yeah. We're certainly looking in the mid-30s.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

You know, again, right now, you know, academic medical centers, you know, represent, you know, a large portion of the accounts, but the fastest growing is in the community, and all the efforts that I just kind of mentioned will get us to at least, you know, 10-15 percentage points, you know, on, I would say, on the low end, by 2025.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

... and then, in terms of the efforts underway to close the policy gaps, improve collections, can you just elaborate on some of those? On a somewhat related note, you know, you talked about ASP headwinds, you know, and those getting better here in the back half of the year. Just walk us through what are the factors that could be driving that improvement.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Yeah. Let me take this from a macro, and then we'll kind of dig into each one of those categories. So first of all, about 70% of our tests right now are currently being paid, and they're being paid at around about $1,450. So really, really nice average selling price for the tests that we get paid on. It's the 30% of those tests, which are accounting called non-paid or like, round to zero paid tests, and what we're really trying to do is close that gap, and that comes in kind of three different areas. One is out-of-policy tests. And if you look at out-of-policy, that means we either, you know, have policy and need to expand to non-covered indications, like mantle cell lymphoma, which we're submitting to Medicare later this year.

And then secondly, CTCL, which is, we're submitting next year. And then there's policies that are in place in myeloma that aren't yet covering CLL or DLBCL, so we need to get a kind of expanded payer coverage for them. And then secondly, there's a bolus of kind of coverage policies that we need to go out and get.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

and so, for example, Centene is one we're in active negotiations with. The other is Anthem. And then the third, there's a handful of Blues, which represent a, you know, significant number of covered lives. The advantage of that, obviously, is you're gonna increasing your covered lives, but also specifically, like with Centene and other significant policies, cover Medicaid.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

And it's that is a, that's a huge issue for us. We have a higher percentage of Medicaid patients, particularly related to kind of pediatric ALL and some other indications, which are essentially, you know, been our drag on ASP. So we have a significant effort in kind of closing those, you know, coverage, really those non-contracted, you know, payers. And then third is operational efficiencies, which kind of is what you started with, which I'll end with. We've got significant efforts on rev cycle management, on making it easier to get prior authorizations, on. There's a whole bunch of things that are based on just on workflow to make it easier to go after collections, how we're going after and speeding up appeals processes, et cetera.

And then third, I'll just mention, there's an industry. I'm sure you most who are invested in diagnostics, but there's an industry-wide problem that we're addressing on Medicare Advantage.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Meaning commercial payers are required to pay Medicare Advantage, and they're putting in onerous requirements in order to get paid. As an industry, I'm on the board of Coalition for 21st Century Medicine, or C21, and a bunch of diagnostic company CEOs that sit on the board with me, we're going after this from an industry perspective, because any one of us doesn't have as much kind of power as we do collectively.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it. Makes sense. In terms of, you know, the Epic EMR integration, you had a press release this morning, you know, moving forward from pilot to, you know, the first site going live. Can you talk about sort of volume contribution, you know, increases? You know, what is the guardrail around that? You know, we've heard about sort of, you know, 50%-100% increases in volume at some sites after EMR is integrated, not specific to Adaptive, but for some other, you know, liquid biopsy companies.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Yeah, we're hopeful, but those are big numbers. First of all, yeah, we're, we're thrilled.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Yeah.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

This has been a major effort, and it's been a major investment for us, that our first Epic site gone live today.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Yeah.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

We've got, you know, three or four more in a very near-term pipeline to get up and running.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

These aren't some of the bigger sites by design. We just wanna make sure that we're-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

... kind of working the kinks out. And then, you know, next year, we've got a planned rollout for, you know, call it another 20 sites that are queued up. In terms of volumes, you know, I'm hesitant to speculate. Here's what I'll say: We have good volume growth baked into next year.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

That multiple factors will contribute to that.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Including, we mentioned blood-based testing-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

... expansion into DLBCL. Epic integration is part of that.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

So we're not necessarily trying to tease out what Epic, how Epic is gonna specifically contribute, but Epic is really... There's two main areas where Epic is gonna help. One is existing accounts increasing the ordering, and then two is access to new accounts that may have been kind of reluctant to order from the portal or just workflow was too complicated, but now we have this kind of ease of use where you go out with connect to this or a kind of plug in, and boom, we're on Epic, and we can send out automatic reminders, build in the order sets that says, in a workup...

Just for those of you, just a little bit more definition, why this is so cool is, when you can build in an order set for when you're treating a patient that has Multiple Myeloma, to every time they come in on your EHR system, it'll pop up and say: We need to do the following, you know, seven things. And one of the things that we're trying to build into every order set is, you need to get your clonoSEQ tested. You need to get your MRD tested.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

And so, yeah, we're extremely hopeful, and it's one of many initiatives we have to grow the volumes.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it. Chad, how many sites are we talking about in the Aura network? And it sounds like, you know, first one goes live today, but where do you think you'll be year-end 2024? Like, will you be sort of, you know, at 75-100 sites? Is that sort of fair?

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

No, I just mentioned, I mean, it's – I would – again, I'm hopeful, but we're talking probably more in the 25-30 sites.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Okay.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

The only reason is, the only reason I hesitate, honestly, we, we could go faster than that, but you need IT resources on the other end.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

I see.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

And it's a matter of getting the attention. So if you look at companies who have successfully integrated into Epic Systems, it's been a multi-year rollout. Like, take Exact, for instance. I mean, it didn't happen overnight. They've seen a huge benefit from it, as will we, but they will roll on. And I hope we can go faster than that, but I don't wanna set expectations, too high here-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

... just 'cause we're not in control of some of it.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it. And in terms of additional EMR providers, how are you thinking about that?

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Yeah, we're, we're evaluating. So Epic is, although, you know, the leading market share, it's, it's largest in the academic medical centers.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

If you start to look at the community, iKnowMed , Flatiron are a couple of systems that we're kind of looking at, integrating with and looking at what they, that investment is. I think just... And again, we're in under evaluation. I wanna see, give it a month or so to see how Epic is working and making sure everything's flowing through the system, and but before kind of moving on to the next one, but it's under evaluation.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it. You mentioned DLBCL, so any color on how you think, you know, the slope of the uptake curve looks like over there in 2024?

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Yeah, yeah, it's one of the growth factors in 2024. We haven't put specific kind of volume growth numbers on it yet, but we've. We're also continuing to refine the assay for ctDNA, making that better.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

That's particularly more important on the pharma side.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

But we have data coming out at ASH, and really one of the biggest growth drivers of clinical uptake is, you know, patient management use cases and, and how you're using the test to change clinical behaviors. So we have more data coming out at ASH, and, you know, you know, ultimately it is, it is, again, one significant component of our 24 growth driver.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it. You know, Multiple Myeloma, you flagged it as a large driver of clonoSEQ use in clinical trials within MRD.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Mm-hmm.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Is this largely due to just the number of trials that are underway in that setting? How do you expect sort of that, that to shift once, you know, CLL, DLBCL, you know, the new clonoSEQ indications, you know, start ramping?

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Yeah. I mean, yes, the reason it's currently the largest contributor to our MRD pharma revenue profile, is that there's a ton of trials going on in Multiple Myeloma. Which is also a little bit of a headwind because there's a lot of competition for patients right now.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

So, you can't recruit the patients, the number of patients that you thought would be, you know, on the trial. But we do see a shift over time to CLL, DLBCL, and frankly, mantle cell lymphoma, even though it's not a huge indication, there's a lot of therapies that are being developed in MCL that we see, you know, as really an important growth driver in MRD pharma for us. I did mention on one call, again, we're improving kind of the sensitivity of the DLBCL assay with the ctDNA assay-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

... which is different than our cellular assay. So it's an area that we've been making investments into, kind of R&D, to you know, expand our opportunity set.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it. You talked about, you know, a little bit of a slowdown in the pharma business with portfolio reprioritization and some of these trials, you know, getting extended and so on. How broad-based is that impact? And given that you've, you know, reiterated the guide, how are you thinking about sort of mitigating that impact?

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Yes. So, you know, we've still got a few weeks to go in the quarter, so we're not going to comment on any quarterly guidance yet. I will say, you know, there is broad-based industry challenges right now related to pharma-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

... both from the Inflation Reduction Act and from reprioritization, which leads to reprioritization of budgets in pharma.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

And again, one of the specific headwinds that I'd mention for us is not just reprioritization, but kind of competition for Multiple Myeloma patients.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

You know, that being said, we've got a strong pipeline and a competitive market position in MRD pharma. You know, if you're starting a trial, you're looking at clonoSEQ as a test of choice in your trial.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it. In terms of, you know, the $400 million eligible sort of milestone payments, and, you know, line of sight to approximately half of those, what about the other half? Over what time frame do you see those sort of being, you know, part of the opportunity?

Tycho Peterson
CFO, Adaptive Biotechnologies

Yeah, I mean, what we said is we've got a line of sight. There's 70 active trials, right?

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Yeah.

Tycho Peterson
CFO, Adaptive Biotechnologies

About $170 million or so, of that $400 million, just under half. You know, we put a 50% probability of success and kind of think about that over the next five-seven years. We'll have mid-single-digit milestones this year, and then we said next year will be bigger.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Tycho Peterson
CFO, Adaptive Biotechnologies

You know, beyond that, yeah, we don't have great, you know, great visibility on kind of the back half.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Fair enough. Chad, before-

Tycho Peterson
CFO, Adaptive Biotechnologies

I should also add, you know, we don't-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Yeah

Tycho Peterson
CFO, Adaptive Biotechnologies

... assume FDA endorses, you know, MRD as a primary endpoint. So if that happens, and it could happen at some point, that's upside.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it. Got it. Chad, two sort of big-picture questions for you before we move to, immune medicine. The potential for FDA LDT regulation, I mean, that's, you know, Michael and I wrote about it in 2012, and still hasn't happened. But every time it, every three years, it becomes, you know, something that investors tend to focus on. So just curious as to, you know, your, your thoughts on that. And then what about the, the, the biomarker bill?

Tycho Peterson
CFO, Adaptive Biotechnologies

Sure.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

And then more states sort of signing up to that.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

... Sure. So I'm not particularly concerned about LDT regulation by the FDA. As a matter of fact, I think the larger, more established labs will probably be beneficiaries of that.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Meaning, like, we've been through hundreds of pharma audits, CLIA, CAP, and by the way, clonoSEQ is already FDA-regulated. We're one of the few diagnostics who've gone through the FDA process on many of our tests. If you look at ALL, multiple myeloma, CLL, all through the FDA. So not a huge concern. I also think, just practically, the FDA is so overburdened right now, their ability to regulate-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

these tests is gonna be a real challenge. And third, there's gonna be a grandfather clause in. So in terms of whether that, you know, practically impacts, you know, our business or the ones that are... most of the ones that are at this conference-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

I wouldn't be particularly concerned about it. The biomarker legislation is interesting in that. So, just put briefly for those not familiar on what this legislation is, it's state, but I think there's 13 states right now-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

-that have biomarker legislation that says that if your test is covered by Medicare, that private payers in that, that have an obligation in that state to cover those patients, through policy. That is not happening right now. And there's a lawsuit in Illinois, and, again, the insurance company lobbies are a lot bigger than... There's not too many profitable diagnostic companies, and in terms of just the money putting into lobbying, is a lot less. Again, being on the board of C21, we're trying to tackle this, as a group, to be able to go and say, "Hey, you need to uphold biomarker legislation." I'm just gonna be practical.

I don't think it's happening anytime that soon that we're gonna win a ton of these lawsuits. It's unfortunate, but my personal opinion.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it. Got it. Fair enough. Switching to immune medicine, Chad, you know, you got the first milestone on IND acceptance, so the first shared candidate. Any sort of sense in terms of when the next milestone within the shared program, you know, would be on the table? And then in terms of what's left to recognize under that, you know, upfront amortization, I think it was roughly $90 million, and Tycho, you talked about that coming through to, through 2025. But any sense of the linearity there? Is it sort of evenly split between 2024 and 2025, or is it more front-end loaded?

Tycho Peterson
CFO, Adaptive Biotechnologies

No, I mean, we said it would be kind of $30-$35 million this year in that range-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Yeah.

Tycho Peterson
CFO, Adaptive Biotechnologies

and then, you know, step it down to kind of 20 next year, and then it tails off, so.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it. Got it. And then in terms of the second milestone, Chad?

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

So we've submitted two additional TCR packages-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Yeah

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

for evaluation for the shared product, and so timing to be determined is when we're giving a milestone on that. We also have the first shared product for which the IND accepted going into trial sometime next year. We don't have a specific date on that yet. And then the private product has been advancing quite nicely, and we're seeing... We're able to, you know, pick out patient-specific TCRs that put a whole end-to-end production facility into our-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

-San Francisco lab, and now we're bringing that through kind of the FDA requirements of GCLP and-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

and other lab-ready practices to be run in a trial.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it. So, two follow-ups. One, you know, just in terms of the private program that you mentioned, the personalized program, what specific steps remain to be done, or what needs to be ironed out before you get to the, you know, the required regulatory sort of stage?

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Well, some of which I just mentioned, we're putting together our part-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Yeah

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

And at the same time, Genentech is putting all the manufacturing in place, et cetera. But remember, this is the first time the agency has seen a patient-specific cellular product.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Yeah.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Right? So there's a lot of conversation with going into the FDA about what the requirements will be in order to submit an IND and to start a trial.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

-on it. Again, it's GCLP on our side, and it's other FDA-regulated lab processes, and then there's manufacturing and other... Because, so the goal is kind of 30 days end-to-end-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Yeah

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

from sequencing a patient's tumor mutations, picking out the T-cell receptors that are specific to those mutations, growing those up, and then putting those back in.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

There's a whole kind of variety of steps, both in, in terms of kind of-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

how you pick those out, what the manufacturing looks like, and how you essentially treat each patient. You know, it's a bespoke therapy for each patient, so what can be standardized-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

kind of, you know, what can't be.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it. And just in terms of the signaling value of that, you know, first milestone coming through from Genentech, has that sort of spurred any other discussions for you with other pharma partners?

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

We're in, you know, constant discussion with pharma partners, related to not just what we can do in cancer, but what we can do in some of the other exciting areas where we're kind of had some nice developments, and particularly in the autoimmune space. So, would I say that specific IND filing driven? Not necessarily, but I would say that we've got some really robust conversations, you know, in play right now.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it. In terms of, you know, the pharma services component within immune medicine, is it subject to sort of some of the same macro headwinds as on the MRD side? How have things been trending there through September, and how do you see that piece of the pie evolving next year?

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

... Yeah, it is. It is subject to the same macro headwinds, frankly, even more so because, you know, MRD, our trials, there's a lot of them, kind of. I'll call it biomarker or research and development work. Where if you're looking at TCR repertoire analyses, you know, are subject more to reprioritization of budgets than kind of MRD, where you're on trial. So yeah, you're seeing some headwinds there related to IRA. And then what was your second question, Tejas? Or did I-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Oh, just around sort of, you know, trends into 2024 for,

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Yeah, again-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Contingent on macro, I'm assuming.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Yeah. Again, I mean, the trends will continue on macro. Again, not commenting on your quarterly guidance. We've got a few weeks left to finalize. But, just to be clear, in our immune medicine business, if you look at the revenue profile, pharma services is one component, and then we do have a, you know, fourth quarter weighted that are really deal dependent.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Yeah.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

That deal dependency, I don't think has that subjectivity to those macro trends that I was talking about. So if you're doing a deal around, you know, for example, a target or something of that nature or some disease state, that really doesn't-- that's not as IRA dependent, like, as, you know, using technology in a trial.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it. Makes sense. You've also, you know, talked about, you know, identifying at least one novel specific disease target by year-end. Where are those efforts? And once you've identified the target, you know, what happens next in terms of developing it?

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Yeah. So again, this is an area that we're pretty excited about, and the research and development has progressed quite nicely. What we talked about is autoimmune disorders, and more specifically, we called out multiple sclerosis.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

This is the area that we're most advanced on. But that really same hypothesis, technology, and platform, and validation steps that apply to multiple sclerosis will apply to, we believe, other autoimmune disorders. So we are in the process of kind of final validation of an MS-related targetment, target. And the thesis here being is that, in multiple sclerosis and in other autoimmune diseases, there are actually a common set of T cell receptors between patients. And once you know that common set of T cell receptors, you can then go the opposite way and find the antigen target.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

So a lot of the work that we've been doing with Microsoft and the technology that we've been developing that was originally supposed to be purposed for, you know, T-Detect, has been extremely useful in identifying novel targets, and we're kind of honing in our first one.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

And then I think the question is, the follow-up was-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Okay, well, okay, what do you do with it?

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Yeah.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

So we're in an evaluation process. Does it make sense to partner the first one? But remember, we developed two different platforms in terms of developing assets against those targets. The first we've talked about with is what we're using in cell therapy with Genentech.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

To be very clear, I do not want to develop a cell therapy platform in autoimmune disorders. I don't think it's a modality that this is gonna be something that's scalable. But we have an antibody platform that we developed for a COVID, really nice COVID antibodies, for granted they weren't co-commercialized, but the platform is very, very good in picking out, way out on the tail, antibodies that have great affinity, avidity, non cross-reactive properties-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

that we believe there's a potential to... I won't say that. I'm going to rephrase that. There's a potential that we can use that antibody platform to go after some of these targets.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Hmm, interesting.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Depending on whether they're class two, et cetera.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it. On the, on the guide, Chad, you know, on your comment around, you know, macro not really being a factor for, you know, some of these, large deals that slipped, in terms of timelines, how are you thinking about, you know... I guess the question is really, how much of the deal timings coming through in Q4 is in your control versus your partner's control?

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Look, anytime you're doing business development deals, I mean, that is certainly-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Right

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

A swing factor in the guidance. You know, the control of a deal is based on, you know, a variety of different factors. I wouldn't say our control versus partners' control. I would say it's collective control as to how soon we can get things done.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it. And how much of a contribution, how much of a swing factor could that be in the guide, in the back half of the year, Tycho?

Tycho Peterson
CFO, Adaptive Biotechnologies

Street, in the fourth quarter, we said about 65% of back half revenues will be in the fourth quarter.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Yeah.

Tycho Peterson
CFO, Adaptive Biotechnologies

Last year, it was 55.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Yeah.

Tycho Peterson
CFO, Adaptive Biotechnologies

A little bit more. The Street consensus is around $20 million.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Okay.

Tycho Peterson
CFO, Adaptive Biotechnologies

We said those are-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

That's what it says?

Tycho Peterson
CFO, Adaptive Biotechnologies

Yeah. We said, look, these are all ongoing discussions, in some cases-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Right

Tycho Peterson
CFO, Adaptive Biotechnologies

... over a year. This is all based on data we've already generated.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Uh-huh.

Tycho Peterson
CFO, Adaptive Biotechnologies

So, like, we're, you know, moving down the path. This isn't stuff we just kind of picked up a month ago.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Right.

Tycho Peterson
CFO, Adaptive Biotechnologies

I mean, we're pretty far along.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it.

Tycho Peterson
CFO, Adaptive Biotechnologies

Yeah, that's the magnitude, $20 million.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

And what's the, I guess, deal concentration there, right? Because they're just sort of two deals, and-

Tycho Peterson
CFO, Adaptive Biotechnologies

We haven't said. I mean, we've said deals, plural-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Right

Tycho Peterson
CFO, Adaptive Biotechnologies

... but we haven't, we haven't said. And, you know, it, it could be a combination upfront, you know, I mean, there are multiple, you know-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it

Tycho Peterson
CFO, Adaptive Biotechnologies

... flavors to deals too, so.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it. Got it. Fair enough. And then, you know, the more of a medium-term question, but as that Genentech amortization, you know, comes down, clearly, that's a significant headwind in margins. You know, you talked about, you know, a bunch of initiatives on, on the COGS front, that could, you know, be meaningful offsets.... Where are you in terms of, you know, your, have you fully transitioned over to the NovaSeq X now or?

Tycho Peterson
CFO, Adaptive Biotechnologies

No, no. So we did a technical evaluation.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Okay.

Tycho Peterson
CFO, Adaptive Biotechnologies

We have to figure out if we're compatible with, you know, patterned flow cells -

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Yeah.

Tycho Peterson
CFO, Adaptive Biotechnologies

-which we are. We've sent the samples to a CRO, and the data looks good. You know, we have to-- we have a fleet of 40 NextSeq-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Yeah.

Tycho Peterson
CFO, Adaptive Biotechnologies

So that's in negotiation with Illumina around trade-in value. They, they'll do matchmaking. They actually won't take it back, so they'll set you up with people, and, and so we're-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

I-

Tycho Peterson
CFO, Adaptive Biotechnologies

You know, then we have to get in the queue, right? And then it's maybe four or five months to actually get a system, and then we'll have to kind of run in parallel with some subset of our NextSeq, you know, fleet.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it.

Tycho Peterson
CFO, Adaptive Biotechnologies

We're really talking about, you know, incremental contributions in the back half of 2024, but really, 2025 is where you're gonna-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it.

Tycho Peterson
CFO, Adaptive Biotechnologies

see the benefit of the NovaSeq transition.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Yes, Chad.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

I was gonna say, one thing that I didn't come up yet, but in terms of margin improvement-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Yeah

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

... there's multiple factors that we're working on for kind of the gross margin improvement profile. But we just basically last week finished a laboratory move.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

We're 2, spread across two buildings, so literally samples were kind of going back and forth. We finally got consolidated all into one building, so pretty excited about that, and so that should help in terms of workflow margins, et cetera.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it. I know once the transition is complete, how much of an uplift are we talking about? Is sequencing roughly, like, 15%-20% of COGS, or is it more than that?

Tycho Peterson
CFO, Adaptive Biotechnologies

About a third.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

About a third, okay.

Tycho Peterson
CFO, Adaptive Biotechnologies

Yeah. So, you know, yeah, I mean, it could be meaningful. You know, there's no reason at scale... I mean, the street does have us getting north of 70% gross margins. There's no reason that, you know, we won't get there.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it. And is it fair to expect, you know, this year, obviously, you're cutting CapEx, OpEx versus last year, but something similar next year from some of the cuts you've done this year, you know, annualizing essentially?

Tycho Peterson
CFO, Adaptive Biotechnologies

Yeah, I mean, our goal is to kind of continue to drive operating leverage.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Yeah.

Tycho Peterson
CFO, Adaptive Biotechnologies

So yeah, I mean, we haven't officially got it for next year, but the goal would be to spend less next year than we're spending this year.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it. Got it. Cash burn, I mean, you know, it's come down-

Tycho Peterson
CFO, Adaptive Biotechnologies

Yep

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

... again, on the last, five-

Tycho Peterson
CFO, Adaptive Biotechnologies

$35 million now.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Yep.

Tycho Peterson
CFO, Adaptive Biotechnologies

Quarter in the back half of the year.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Do you think there's room to go lower, you know, next year? And what, I guess, is a question for you as well, Chad, I mean, how are you thinking about the balance there, right? Because at some point, you don't wanna start cutting into bone. You don't wanna compromise on top-line growth, but obviously, you wanna run a lean, mean operation, so.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Yeah, absolutely. I mean, the balance is that we're allocating capital as efficiently as possible-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

... and looking for operating leverage. You know, and the reality is, I think, we grew too fast during COVID. A lot, a lot of us did, but I'll, I'll point the thumbs here and say we grew too fast. There was additional layers of management that we frankly needed to take out, and there's ways that we can do things a lot more efficiently.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

And so there's no stone unturned in terms of looking at how we can be more efficient. That is not in any way to sacrifice, you know, growth in terms of volume growth-

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Mm-hmm

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

... and certainly in the MRD business. But we do certainly need to look at, you know, how we're allocating capital between the different business opportunities and segments.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Got it. We're out of time, so that's a great place to leave it at.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Yeah.

Tejas Savant
Executive Director, Life Sciences Tools & Diagnostics Analyst, Morgan Stanley

Thanks so much, guys. Appreciate it.

Tycho Peterson
CFO, Adaptive Biotechnologies

Thank you.

Chad Robins
CEO & Co-Founder, Adaptive Biotechnologies

Thank you. Appreciate it.

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