Adaptive Biotechnologies Corporation (ADPT)
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TD Cowen 44th Annual Health Care Conference 2024

Mar 4, 2024

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Great. Welcome to day one of the TD Cowen Global Healthcare conference. I'm Dan Brennan. I cover tools and diagnostics. Really pleased to be joining with me here on the stage of Adaptive Biotechnologies senior management. We have Chad Robins to my immediate left, CEO and co-founder, and then to his left we have Tycho Peterson, who's Chief Financial Officer. So, guys, welcome.

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

Thanks, Dan. Appreciate you and TD having us.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Definitely. Yeah, yeah, maybe, I think, you know, the high-level question to just kick it off would be, you know, the decision you made, and we'll find out more details, obviously, soon in terms of the strategic evaluation of the two businesses. You know, Chad, when you and I met in the past, or, you know, years ago when I first started looking at Adaptive, you had the MRD and Immune Medicine business, and there was like a, you know, a bit of a lock and key how they fit together. And then, you know, obviously, you know, not too long ago you decided, you know, listen, let's make sense. There's enough, maybe incongruities between them to kinda pull them apart.

Maybe just walk us through a little bit of kinda what drove that decision, and, you know, while we don't have the details yet of what's gonna happen, anything you can say about the process.

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

Yeah, sure. I think what we recognize is although in the past there has been some platform.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

What? Oh, it's not on?

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

I can't see it, though. Sorry. No way.

Testing?

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

All right.

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

Can you hear me?

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

It's okay.

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

Yeah.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Okay. Perfect. I think what we recognize is unless your name is Roche, having a diagnostics company and a therapeutics, or drug discovery company under the same umbrella is challenging. It's challenging internally and externally. I'll just describe internally. In terms of capital allocation, in terms of human capital and focus, are two of the big ones. Externally, you know, if you look at our investor base who skews predominantly towards life science tools and diagnostics, and then you have kinda therapeutics ex investors that skew towards really understanding deeply drug development pipelines, those are really two different things. Also analyst coverage, right? I mean, think about it.

Like, you know, the coverage and the questions that we're getting, 90% of them relate to, which we're gonna talk about today: MRD, penetration volumes, ASPs, leverage, you know, all of those things that are blocking, tackling, building, a diagnostics business. Ultimately, I think there is value, from stratifying patients and using diagnostics to stratify patients to really improve the probability of success of clinical trials. Some of the work that we've done and actually continue to generate data, for what was called T-Detect , but really to essentially diagnose patients, to understand who's gonna respond, who actually has the disease. 'Cause fundamentally, you know, we're able to kinda unlock new biology both on the DX and new drug discovery targets in autoimmune, in the Immune Medicine business, which we'll talk about, in a minute.

So we recognize that, and we also recognize from a market cap standpoint, we were just talking about it, essentially we're getting, if you can just provide any traditional metrics on the MRD business and recognize that it's being driven down in value in these markets by the spend that we're putting on Immune Medicine 'cause it's not appreciated. So. Got it.

Okay. So I know you've discussed, you know, you'll be communicating results by the end of the quarter. You know, I'm just wondering, is there anything from a high level maybe not about what's gonna happen, I get it, but just about the process you've undertaken or what we can expect at the end of the quarter? What would be some of the options?

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

Yeah. I'll just tell you that we recognize in the thesis and the problem, which was just outlined, that we can unlock value by looking at these businesses in some way, shape, or form, and in context as separate and allocate capital to them is separately. We've looked at a variety of different options, and it's been kind of eye-opening, surprising that there are a lot of different opportunities out there to really think about it. And what we're really doing is thinking about how do we kinda maximize, not think short term, right? 'Cause I think there's opportunities to do things short term, which could potentially grossly undervalue one or both of the businesses.

So we're really trying to think about, hey, believing in our thesis, if you can kinda project forward, you know, a couple of years with the right investments in place, what does this thing look like?

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Mm-hmm. Okay. And is it still on track by the end of the quarter? We'll get an update?

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

Yeah. We're looking end of the quarter.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Got it. And that would be today. There'll be an email that says news announcement, and you'll host a call, or how do you think we'll go through it?

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

Yeah. Yeah. We haven't really put out yet how we're gonna communicate, but.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Got it. Okay. Maybe just think about the guidance for 2024: low single-digit Pharma services, ex- milestones, and MRD, and then 45%, I think, plus growth is what we wrote in clinical MRD business. Maybe when you think about that low single-digit growth rate, can you just walk through some of the assumptions that went into that?

Tycho Peterson
CFO, Adaptive Biotechnologies

I mean, look, that's an area where we tried to be a little more conservative, right? We felt the headwinds, as did we all of our peers in 2023, from, you know, IRA and pharma kinda reprioritizing trials. And so that's just an area where, as we thought about the start of the year, where we wanted to bake in a little more conservatism. You know, the 40.5% growth, you know, you referenced, includes volume and ASP, right? We also said, you know, the Street had about 35% volume growth, and we're pretty comfortable with that on the clinical side for pharma.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Mm-hmm. And kinda back to the pharma side, like, can you is there any color on pacing in kinda what you've seen? If you look back six months ago till today, is kinda what's changed? Are kinda things stabilizing? Is there a bifurcation between regions? Any color about what you're seeing in your pharma book of business that would give people some confidence in that low single-digit growth rate?

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

Yeah. I mean, I don't think a ton has changed. One other thing on guidance, we are guiding conservatively on the milestones.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Mm-hmm.

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

Because we don't really control the timing of drug approvals or patient enrollment. But yeah, I mean, the MRD business, the pharma business, we've gotta deal with the macro in terms of IRA and reprioritization of budgets. And then there's some stuff that's more specific to our business, for example, kinda patient enrollment in multiple myeloma trials, which are getting crowded, that's had some impact. But that's all baked into the guidance. You know, we just have a thoughtful kind of approach to trying to guide, you know, on a conservative basis and be able to hit that. But ultimately, you know, we've seen the business stabilize, you know, over the past six months.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Mm-hmm. And does biotech funding like, you're dealing with mostly—I mean, I don't know what the spectrum of companies is from the small to the large, but funding's definitely gotten better, starting to percolate. We're starting to hear that from investors are really gravitating towards that. How does that funnel through that business? I mean, is that something that happens with, like, a year lag? 'Cause by the time you start with a customer, I'm just wondering, you know, is there a connection?

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

Yeah. It depends on stage. But if you're talking about funding kinda early, 'cause at least in the MRD business.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Mm-hmm.

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

You know, which is the only business we're guiding on. So I'll make some commentary on kind of Pharma Services and IM. But on the MRD business, you have to be in clinical trials.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Mm-hmm.

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

Incorporate clonoSEQ, MRD into your trials to be able to get paid. So there'll probably be some lag if you're funding earlier-stage companies. In terms of Pharma Services, and doing kind of, I'll say, PCR repertoire work, you may have some more of a sooner near-term impact, but it's relatively negligible with respect to our numbers right now.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Got it. Okay. Maybe, maybe just zooming out, just on clonoSEQ, you know, obviously it's you guys were the first mover there, dominant position in blood, but still a ton of opportunity from a penetration standpoint. Maybe I think sometimes we get so into the weeds on, like, the incremental numbers that sometimes fail to kinda zoom out. So just if we think about the technology, what's differentiated the utility, just could you kinda speak to a little bit, like, what makes clonoSEQ unique? And just from a competitive standpoint, you know, if we looked out 3-5 years, is it still gonna be the dominant player?

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

Great. Yeah, thanks for that question. I wanna say clonoSEQ is widely considered the gold standard in heme MRD. There are significant moats around the business that'll be there for many, many years to come. If you think about just as a comparison to kinda solid tumor MRD, where there's kinda 10-20 players, obviously Natera is pressing their intellectual property advantage and doing, doing, doing pretty well there. There's really one player in heme MRD, and that's Adaptive with its clonoSEQ test. Now that I mentioned IP, let's start there. We have a phenomenal intellectual property position. You know, there's tens, tens and tens of patents that cover, not only the underlying technology, but also the application of it to heme MRD. Then second, the technology itself.

If you look at both the specificity and sensitivity of the test, what we do is essentially, because these are the, most of the cancers we're targeting are cancers of the immune system cells, we're actually able to directly count the malignant cancer cells. And that's kinda your numerator. That's the number of malignant cancer going as a percentage, or, in the denominator is your total healthy cells. So very, very sensitive at a specificity of over 99%. I mean, this is an incredibly sensitive and specific test, so it's really hard to if you're coming at it a different way, to be able to achieve those bars that we set, both with Medicare that we set with the FDA, is really, really challenging. The third competitive moat I'll point to is our relationships and integration into pharma.

We have 65 pharma partners, 160 active trials that we're on, right now, and those businesses are incredibly synergistic. So if a pharma company incorporates you into their trial for any of the new drugs that are emerging in heme, then they're also using those—those clinicians are using those drugs in the clinic, and you're—they're using the tools that are on the trial to monitor the effectiveness of response and monitor that patient over time to see the kinda changes in payer, changes in tumor burden. Next area I'll point to is payers. We're by far the most kinda widespread in terms of reimbursed tests, both reimbursed from Medicare in multiple myeloma, ALL, DLBCL, and CLL.

And we have over 300 million lives covered in multiple myeloma and ALL, and coming up in CLL and DLBCL are the next areas in terms of kind of the payer landscape. And then just I think I'm on 5 or 6. It just our IT kinda relates to we've got a, you know, a couple hundred publications, a ton of studies, the top key opinion leaders. We're entrenched now in all 33 of the NCCN cancer centers. So we have a very kind of established position as an and significant moats around the business, that I think will be here for many years to come.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Okay. Maybe just on the $200 targeted realized ASP increase you're guiding to over time for clonoSEQ. Just, Tycho, can you just unpack that a little bit? What drives it? Like, how much of it is you're not getting paid and you will get paid? How much of it's just, just kinda walk through the, you know, kinda that, that, increase and what the visibility is.

Tycho Peterson
CFO, Adaptive Biotechnologies

Sure.

Are you going?

Oh, you're going?

Yeah.

Oh, yeah. I would—I'll start and hand it off. But, you know, we get paid on about 70% of our tests, right? So, you know, expanded coverage is part of it. You know, we've guided for a couple new plans this year. There's some big ones like Centene that we don't have. Prior auths have been a big focus, so we've done a lot of work and have actually started to see some real benefit there on working around prior authorizations. You wanna touch on some of the other initiatives?

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

Yeah. So you mentioned, kinda out of contract, there's also out of policy. So we may have a contract, but certain indications are out of policy that accounts for a decent amount. We're kinda by naturally reducing the percentage of Medicaid, which is a historically low payer. And you mentioned prior auth, but just in general, the operational enhancements for revenue cycle management, appeals process, you know, faster collections on claims, going after Medicare Advantage for unpaid claims. There's just a ton of kinda blocking and tackling in addition to what I'll call kinda the strategic market access and positions that we're taking. We've already submitted, just in terms of kinda further expansion, we've submitted on MCL to MoLDX and LCD, so we expect or we let me say hope.

We hope for a coverage decision in the first half of this year on MCL, and then CTCL, another kinda lymphoma type. We're gonna be submitting kinda towards the end of this year, as well.

Tycho Peterson
CFO, Adaptive Biotechnologies

We've also played around with the comp plan a little bit.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Yeah.

Tycho Peterson
CFO, Adaptive Biotechnologies

You know, we just actually came from the national sales meeting.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Yeah.

Tycho Peterson
CFO, Adaptive Biotechnologies

So there's a ton of energy right now, so it's good.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Got it. Is there anything, like, as you've gone through the strategic review process and different suitors, different players have looked at your businesses and scrubbed them, and is there anything, like, when people look at clonoSEQ that they don't like, that they say, you know, this is a reason, or, I don't know, maybe it's maybe it's done so well. There's not a lot of growth left, or I don't know? What are some of the pushbacks you get, like, on the clonoSEQ franchise, if any?

Tycho Peterson
CFO, Adaptive Biotechnologies

I mean, I don't think we wanna comment specifically on the review process.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Yeah, sure.

Tycho Peterson
CFO, Adaptive Biotechnologies

I mean, what we can say is, you know, that business is clearly not profitable today. We've laid out the path to profitability, and we're taking a lot of steps, you know, to drive both gross and operating margins. So we feel good about that. But, you know, that's one thing investors bring up, and, you know, other people might look at too and say, "Look, it's not profitable today.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Mm-hmm.

Tycho Peterson
CFO, Adaptive Biotechnologies

We're, you know, a year away from getting there, so or a year and a half, but.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Mm-hmm. Okay. So you know, our diligence with oncologists revealed, in many cases, clonoSEQ is prognostic but not predictive. So which clinical trials do you think are most important to the medical community that might drive that view of, like, it's really predictive about the utility of clonoSEQ? I know you've got a bunch that are rolling and, you know, they continue to mature, but any wants to kinda note in the next couple years?

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

It's interesting this kinda depends on your definition of prognostic versus predictive because we're certainly predictive of outcome. If you're MRD negative, you're gonna have your sustained MRD negativity is gonna lead to a higher progression-free survival. If you're MRD positive, you're relapsing quicker. We've shown that in study after study after study.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Mm-hmm.

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

So again, and depending on kinda the clinician you talk to and how they use that definition. But we've got a lot of studies, you know, one and we'll talk more about, I assume, blood-based testing.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Yeah.

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

Blood-based testing in multiple myeloma, we had a University of Chicago study that we presented at ASH, and we'll continue to generate data there that says kinda early on in the treatment cycle kind of that you can if you measure MRD, that kind of is very predictive of outcomes. We have a study with Genentech, the Cristallo study in CLL. That's important. We have further data readouts from the MASTER study in multiple myeloma that says that if you're MRD negative on subsequent tests, that you can discontinue maintenance therapy with no reduction in your progression-free survival. We've got studies that says if you're MRD negative, you don't benefit from a transplant in multiple myeloma, and that your outcomes are the same transplanted or non-transplanted if on MRD negativity.

So continuing to generate a host of different data across indications that show not only the clinical utility of using the test for that indication, but particularly at different time points across the patient-care continuum.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Obviously, it's an obvious question. You guys have a slide in all your decks discussing relative penetration. But when we look at, like, say, the next three years across your different indications, which one, you know, they all have a lot of headroom. Which one or two do you think has the most opportunity to see that penetration curve go up?

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

Well, our largest indication and fastest and kind of largest growth opportunity continues to be in multiple myeloma. There's a, you're right. We're only 20% penetrated there. I'm sorry. We're only 9% penetrated there. We're 20% penetrated in ALL. So there's a tremendous amount of headwinds. One of the ways we're gonna get there in myeloma, right now, 18% of our myeloma tests are done in the blood. We think we can majorly improve that, which also kind of ties into our work in the community where they're more easily able to access a blood sample from a patient than they are from a bone marrow. DLBCL is a nice opportunity for us as well. It currently represents 35% of NHL, so it's the largest category in NHL, DLBCL. Remember, we just launched it last year.

It takes time in these indications where MRD traditionally hasn't been used for the TCR test to become kinda standard, or more standard of care in the different practices. But we're just starting to see kinda that some nice cracks in the DLBCL. And then I mentioned MCL as a new indication coming up. It's not a huge indication, but it represents about 5%. It's about 5% of our volumes right now, and we'll get paid for it and be able to promote it. It's gonna be exciting. CTCL, which currently a lot of our business is roster bill. We'll be able to convert that to, you know, reimbursed billing. So yeah, we're looking to grow across indications with multiple myeloma being the largest.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

In terms of, like I think you guided I don't know if this is at, you know, earlier conference this year, but 25%-30% clonoSEQ revenue CAGR, right? That was a longer-term view that you had given.

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

Mm-hmm.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Versus the 45% and 24%. So does that imply, like, a step down to, like, 10% in, like, three or four years? Or just how do we think about the decay rate on that, given your—I mean, the penetration rates are still really low. You have some pricing opportunities. So it feels like you should be able to sustain, I would think, 20% growth for the foreseeable future.

Tycho Peterson
CFO, Adaptive Biotechnologies

Mm-hmm. Yeah. Just I mean, law of larger numbers, some conservatism.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Right.

Tycho Peterson
CFO, Adaptive Biotechnologies

You know, we've been clear about our pricing assumptions in another $200 in the next two years.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Mm-hmm.

Tycho Peterson
CFO, Adaptive Biotechnologies

On clinical ASPs. But yeah, there's some conservatism in that.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Mm-hmm.

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

You can also remember, if you as a blended average, if you're looking at 45% on the clinical business even this year, and you're looking at kinda 10%-15% on the pharma business, you blend those together, your CAGR is gonna be lower than the 45.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Right. No, that's a good point. And maybe just one more on, on blood. So, is there any you know, you kinda rattle off a few studies or maybe one study in blood. Is there any one study that will dramatically, like, alter or really have an inflection point in blood, for, for, you know, whether multiple myeloma or just kinda walk us through what the pathway is for blood penetration and, you know, how important it is?

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

Yeah. I think the most important study, which I mentioned, is the University of Chicago study that evaluates clonoSEQ versus other serum-based biomarkers and shows the clear-cut utility of measuring MRD in the blood with clonoSEQ versus the utility of those other serum-based biomarkers. But just taking a step back on blood, kinda right now, overall, I mentioned multiple myeloma blood, 18%. Overall, in our portfolio, blood represents 30%-37% of tested volume. That's because certain indications are only done in the blood. Like, CLL started in the blood. DLBCL started; it's a ctDNA test, which is a little different than the cellular technology, started in the blood. So, but we're looking to get to the overall portfolio. Remember, with myeloma being the highest grower, from 37% to 50% by 2027.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Mm-hmm.

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

And so I think that'll also impact why blood is so important. It'll also impact the number of time points per patient that a doctor will test. So that'll increase. There's many ways to increase volume and penetration. One of them is the number of tests done per patient in addition to signing up new patients, signing up new HCPs, etc.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Mm-hmm. Okay. In terms of the milestones on MRD, you have $300 million, I think, of potential milestones. Just walk us through how someone should think about the time point or the pace at which those can be leveraged.

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

Yeah. It's actually, the actual overall available milestones to us is higher than that. It's about $440 million.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Okay.

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

But of which are currently available.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Got it.

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

It's closer to $180 million. So these are actually so just taking a step back, when we sign, for example, like, a integrated portfolio master service agreement with an AbbVie that covers all their indications, some of those trials have started. Some of those might not have started, or might start in a year or two or three years. So how that works is if and there's different kind of constructs to this, but just in general, if MRD is used as an enabling technology for approval, we will get paid on the approval, whether it's a surrogate endpoint whether some are just paid whether it was used, some of whether there's a surrogate endpoint, and then some, which you were hopefully going to be able to access, is a primary endpoint.

If it's approved for a primary endpoint, we get a higher set of milestones. So when we first of all, we've guided conservatively to these milestones because for a couple of reasons. One, as I talked about, we can't control how fast these studies enroll. We also can't control the outcome of whether a drug is gonna have a positive approval or not. So we've, and it and timing is such an issue. So we've just kind of taken a more conservative approach to kinda probability of success and timing of those. So it could be a potential kinda area of upside for us if we're able to access those milestones kinda sooner than in our numbers is an opportunity for us.

And then the other opportunity is the FNIH and International Myeloma Working Group. There is positive chatter out of them that the FDA is looking at multiple myeloma MRD as a primary endpoint in multiple myeloma trials. And that's pretty exciting news and could enable us to be able to kinda tap into and access some additional milestone payments that are built into our contracts.

Tycho Peterson
CFO, Adaptive Biotechnologies

And we previously said something about that over kinda 5-7 years on the milestones and 30%-50% probability of success.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Got it. Got it. Right. And the real slowdown there has just been more the environment is what is kinda the biggest factor as opposed to anything fundamental to penetration rates or anything going on with, like, the specific categories?

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

I think it's twofold. It's less of that. I mean, it's some of it, like, specific to myeloma, it's a lot of companies are developing myeloma drugs. Competition for patients and enrollment has been slow. Overlay that kind of IRA, and what that might mean for us is cutting down the number of time points.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Mm-hmm.

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

That you test per patient. So if you're gonna do, like, you know, five or seven, you might do kinda three or four instead. So that would take down kinda the overall revenue profile of the sequencing part of that, not related to milestones. So those are just a couple of areas that you think about, you know, overall penetration. And then the other one is, you know, some of the growth projections, DLBCL, which I think we're gonna be able to access. We just created a v2 version of the assay. And some companies maybe would be waiting for FDA approval on that, which we're kind of working on.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Mm-hmm. Okay. Just in terms of the profitability, so, maybe can you speak to just clonoSEQ, I mean, the MRD side itself? Like, what, like what can you share on the gross margin side, on the OpEx side? Just, you know, what are the key levers to get that business to profitability?

Tycho Peterson
CFO, Adaptive Biotechnologies

Yeah. So there's a couple of dynamics here. There's the pricing I mentioned, $200 in ASP over the next two years. You know, we've said at scale, MRD will be 70%+ gross margin. So, you know, that's not next year, but a couple of years out. We've talked about some of the steps to get there, including, you know, the transition from NextSeq to NovaSeq. That allowed about eight points to margin. So that's a big part of it. We're doing a LIMS overhaul. We're looking at how we pack flow cells. We're reducing the number of extractions. I mean, there's a lot going on kinda within the lab, within workflow. That's gonna kinda help drive those margins for MRD overall, including pharma, by the way. So pharma pricing's twice that of clinical. So that.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Mm-hmm.

Tycho Peterson
CFO, Adaptive Biotechnologies

You know, naturally has a higher margin. But we've said overall, it's north of 70% in the next couple of years, so.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Then, like, studies say that that was standing on its own. So what's, like, the OpEx load that should carry? Like, what kind of margin?

Tycho Peterson
CFO, Adaptive Biotechnologies

Well, that was, so we laid out that path to profitability, right, kinda EBITDA positive by the end of 2025 and cash flow break-even in 2026, so.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Right. So from, like, analysis, sales, and marketing, R&D, I know I have notes in here in terms of the burn. But any way to basically get gross margins is 72%. We look at the revenue number, and that's the OPEX just to kinda get the, that's EBIT profitability, right?

Tycho Peterson
CFO, Adaptive Biotechnologies

Yeah. EBITDA. Yep.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Yeah. I got it. How about steady state? Like, where could that business six, seven years from now, like, if it's on its own, like, what's kind of a run-rate margin that the MRD business could kinda maintain, you think?

Tycho Peterson
CFO, Adaptive Biotechnologies

I mean, we haven't given guidance, you know, that far out. But I mean, we're no different than other clinical labs, right? I mean, it's not like our sequencing burden's that high. So, I think it'd be kinda consistent with, yeah, some of the other peer CLIA labs that you might look at.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Mm-hmm. So maybe just before we, I mean, I wanna go back to the margin. Just, I know you're not guiding to me, Nitin. Like, is there anything from a high level when you talk about the positive attractive attributes of that franchise? Just maybe, like, what is it that makes that business attractive without necessarily giving any numbers? You could speak to, like, the profile of it, right?

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

Yeah. Sure.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Yeah.

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

I mean, that business probably has the largest upside potential. We have more data amassed on the adaptive immune system and the adaptive immune system's interaction with antigens than any business. Just to give you a sense of scale, we've mapped, you know, 500,000 fully paired T-cell receptors against HLA-presented antigens. It's more than 10 times all the data in the public literature combined. And some of that data is our. A lot of it's our data. So what does that mean? So we're focused in two primary areas, which is cancer.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Mm-hmm.

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

And autoimmune disorders. In cancer, we have our partner program with Genentech, and I fully recognize this has been slower, probably more costly, and more challenging than expected. But it's moving along really, really well. I mean, Genentech built a football-sized manufacturing facility for cell therapy, you know, outside of Portland. So they're making huge investments into this. And we, you know, hope to be in the clinic later in the this year in our first shared product.

And secondly, you know, the private product or personalized product is only a year behind. So that's exciting on the partner program. But what's been really eye-opening and exciting to us is kind of the whole kind of biology. We're unlocking kind of a new category of targets in the autoimmune space, starting with multiple sclerosis. And I, I'll just make this comment.

I've made it before, and I apologize if it's repetitive to any of you. But kinda AI is just a tool. It's an amazing tool. But you need data. You need a lot of data, and you need very well-curated data sets. And we have that. We have that on the immune system. And what that is leading to is a set of discoveries and that will really kinda change how drugs are developed and discovered. That's a big statement, but we believe that that's exciting and true. Now translating that and the time frame around it, which is, again, taking a step back and going to your initial question, Dan, is we recognize that there's time horizons, milestones, and, you know, really a different profile for value inflection. But we are excited about the business.

We're also just taking a step back. We just want to alleviate anyone's concerns here. We fully recognize that we need to capitalize the MRD business first and foremost so that it gets to profitability with a significant cushion. And then once we do that, we'll then need to make sure that we can essentially be able to feed and invest in the Immune Medicine business to unlock the potential. 'Cause we know what we have in terms of this burden ahead. We also know the promise of Immune Medicine. But we also, we need to make sure kinda we're balancing those constraints as we kinda think about, you know, how we're, you know, how we're looking at unlocking the value of both of these business opportunities.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Have you ever talked about, like, what the like, how much a business like that would have to be capital separate from the strategic review process? If you just said, "Immune Medicine, here's how much capital it would need over the next five years." I don't know. Any way to think about that?

Tycho Peterson
CFO, Adaptive Biotechnologies

We haven't commented publicly. Yeah.

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

We do have a very good idea internally. And we will come out with that information as to, you know, how not only well, I think the question is, how much capital, how long will it take you, and what milestones are you able to achieve with that capital so that you get a value inflection.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Mm-hmm.

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

From that initial set of capital so that whatever investors, whether they those be our current public market investors, whether they be other investors, so that they're able to have a, you know, a step up based on, you know, hitting certain achievements.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

How is that business? Are there a lot of biotech companies maybe not doing the same thing but are in the same zip code, right? Just to kinda how is your business in terms of if, you know, on the biotech side, you started off by saying, "Yeah. It's mostly tools investors." But there are biotech investors, obviously, who look at Adaptive. When you think about the competitive landscape for what the Immune Medicine's doing, how differentiated is what you're doing?

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

I would say very.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Mm-hmm.

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

Very differentiated in just in terms of the amount of data we have. And then the not only the data, just the tools that we have and the experience we have in sequencing, mapping, characterizing, immune receptors, and now kinda overlaying, you know, AI to remember, for those of you who aren't aware, we've had a partnership with Microsoft since 2018. And we work very, very closely with them. So we've gotten access to a talent pool that we, frankly, probably wouldn't have been able to hire on our own. So that's accelerated things. I mean, we're not a like, we're not coming out in 2024 and saying, "Hey. We wanna be an AI drug discovery company." I think, you know, I think we've been doing this for years.

And that's why I say AI is awesome. It's a great tool. It's one that we've been using. I think the advances in that AI's made in terms of AlphaFold, AlphaFold 2, and in the last, call it, nine months have increased our confidence. So, like, the protein folding problem's been solved, but 'cause of the protein, the protein-antigen interaction, there's things that we believe that our data can feed to be able to impute binding.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Mm-hmm.

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

Between, for example, your T-cell receptor and an antigen, that you wouldn't necessarily have to do, that you could do in silico now. So those are things that are, I think, excite us, you know, quite a bit. And we're seeing really, really nice data and early traction on that, that's sort of frankly and I understand. I understand that that's kinda black boxy and earlier hard to value. But it's there, and it's got value. We just need to start translating it.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Maybe we're out of time. But what's.

Tycho Peterson
CFO, Adaptive Biotechnologies

One more.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

What's the message you wanna leave for investors about the Adaptive story?

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

Yeah. Sure. Well, that was a good one. And we've really had two very compelling, you know, business opportunities here. And we're being incredibly thoughtful about how we can unlock the value of these two opportunities. MRD is a true penetration, blocking and tackling, leverage, get to profitability. It is absolutely the gold standard in the industry. And we're looking to continue to press our advantage there. In Immune Medicine, like I said, we've got a tremendous amount of data.

We're seeing incredible, kinda discoveries that we think are gonna unlock, I'll say, targeted therapy in autoimmune disorders with the understanding that it's gonna take some time to get there and that it's a different animal and that we need to make sure that we kinda can align an investor base with the enthusiasm and excitement, opportunity, and time frames associated with that.

Dan Brennan
Managing Director and Senior Equity Research Analyst, TD Cowen

Great. Well, guys, thanks for being here. Thanks for everyone in the audience. Have a good rest of the conference. Thanks.

Chad Robins
CEO and Co-Founder, Adaptive Biotechnologies

Thanks, Dan. Appreciate it.

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