Adaptive Biotechnologies Corporation (ADPT) Earnings Call Transcript & Summary

May 10, 2023

NASDAQ US Health Care Life Sciences Tools and Services conference_presentation 31 min

Earnings Call Speaker Segments

Derik De Bruin

analyst
#1

Good afternoon, everyone. Welcome to Bank of America's 2023 Healthcare Conference coming to you live from the fabulous Encore Hotel in Las Vegas. I'm Derik De Bruin, the Senior Life Sciences, Diagnostics and Tools Analyst for Bank of America. And it is my great pleasure to introduce our next company, Adaptive Biotechnologies. And with us is Chad Robins, Co-Founder and CEO and Chairman; and Tycho Peterson, CFO. So, welcome, gentlemen. Thanks for being here. Thanks for schlepping out to Las Vegas.

Derik De Bruin

analyst
#2

Big news this morning. You want to just get straight to that. And talk about the Genentech news and in terms of -- along with it or not. I mean we can...

Chad Robins

executive
#3

Yes. I'm happy to talk about that, Derik. And first of all, thank you, and thank you to BofA for having us out again at the BofA Healthcare Conference. Yes. So, a really exciting news today. Genentech, we announced that our partnership with Genentech had the first IND acceptance in our cell therapy partnership in oncology. And this has been a long time coming, but tremendously exciting for us in that this program has got squarely on track and make no mistake about it. I mean we're trying to treat cancer in an entirely new way using patients with T cells and to attack solid tumors. And we couldn't be more excited to activate this side of the business in immune medicine.

Derik De Bruin

analyst
#4

The financial impact, I mean, this is -- I mean, you had some milestones that were strengthened. I think -- this was I thought this was coming to 4Q and then it's in 2Q. So, how does the milestone math work?

Chad Robins

executive
#5

Yes, we want to kind of moving up. This wasn't this year's guidance. We want moving it up 2 quarters. It is squarely within guidance, but it's nice to see kind of that derisking event happening earlier.

Derik De Bruin

analyst
#6

And what's the next steps for this then?

Chad Robins

executive
#7

Well, the next steps, if you recall, there's 2 programs associated with the partnership. The first is what we call the shared program and the shared is going after kind of shared cancer antigens with defined T cell receptors that have certain properties that make them great targeting molecules for therapeutic use. And we've already delivered to Genentech 2 additional shared cancer antigen packages, which we're evaluating for that part of the program. At the same time, in parallel, we have what we call a fully personalized cell therapy approach. And the next step for that is an IND filing. We haven't yet given guidance around timing. But the good news is there's been some compression, understanding that the first shared product took a little bit longer than expected, but we've been working in parallel and the data is looking really, really, really good on the private program and we're excited about it.

Derik De Bruin

analyst
#8

Then let's move on to some of the things. So, I want to ask a big picture question to start. You reported Q1 results last week, which was solid. Nothing stood out, pit numbers, guide was fine, yet the stock basically, you got kicked in the teeth. I'm just sort of curious as to what -- I know the markets are tough for early-stage stocks, but what do you think happened? And what do you -- I guess, what do you think needs to happen as we get investors more improving on Adaptive?

Chad Robins

executive
#9

So, I don't know -- I think what happened kind of related to this quarter was kind of a transitory kind of margin compression. And I'll hand over to Tycho in a minute to discuss that. But kind of bigger picture, there's a few different things that need to happen. The first is solid execution around MRD. Quarter-over-quarter growth we discussed and outlined a path to over 50% test delivered growth in 2023. The second, which happened today is we need to show that the immune medicine side of the business really is a valuable component of the business. And that started with the first acceptance of an IND. And also, we're working on kind of several internal programs with novel targets in autoimmune disorders and we need to show progress on that front. The third is operational efficiencies. We have a very concerted effort to very -- manage our capital allocation and very, very carefully look at how we can extract costs from the business in a very, very efficient, meaningful and smart way. And then the fourth, it should be noted, I mean, we have a $440 million cash balance on our balance sheet. And we're being very smart about how we deploy that cash between very discrete objectives in both the MRD business and in the immune medicine business. But Tycho, can you maybe kind of give some color around margins for the quarter?

Tycho Peterson

executive
#10

So, we went from about 66% a year ago to 50% this quarter and that drop off was partly due -- almost entirely due to 2 factors. One, the Genentech amortization, which you know, as we talked about at the beginning of the year, is effectively going to be half of what it was last year, just over $30 million. And that tends to be close to 100% margin. And then royalties, we didn't have any MRD, sorry, milestones this quarter, and that's 100% [ margin ] and we have milestones. So, the fear is that coming out of the quarter, there's a lot of concern that our underlying margins are going to be kind of baselining at 50%. A couple of things I'd highlight here. First of all, there were some other noise around margins and we had a scrap write-off. We were moving our lab. We were moving and then higher volume through our production lab, which tends to be lower margin. So, there were some kind of transitory stuff as well. There's always going to be mixed dynamics around margins in any given quarter. What we're kind of highlighting here going forward is we have a huge initiative around COGS right now. And as we started to kind of get in there, there's a lot of low-hanging fruit. If you kind of look at workflow, there's a lot we can do around extraction that we're looking at upgrading to the newer Illumina sequencers. We're running everything off 10-year-old NextSeqs at this point. And so as we kind of looked at the lab ops part of it, overhead is about half our COGS in the lab. We see a very clear path for margin improvement going forward. No reason that at scale, we can't be kind of a 70-plus percent margin business, maybe closer to mid-70s [ at that time ]. So, there's nothing structural around our margins. It just historically hasn't been as much of a priority given our growth initiatives. But we're going to be very clear about our expectations on margins going forward. Hopefully, we'll be able to guide around that at some point in the future.

Derik De Bruin

analyst
#11

So with -- that obviously means is sort of thinking about rejiggering the margin math now that you've got the milestone early, so it will be big...

Tycho Peterson

executive
#12

Yes. So, 2Q…

Derik De Bruin

analyst
#13

That means 4Q. Yes, so that will be, so things will just shift around a bit.

Tycho Peterson

executive
#14

Yes, and then the other side of it is ASPs, right? We're doing a lot of work around ASPs and obviously, that will lift too.

Derik De Bruin

analyst
#15

So, remind us on your cash runway, I mean, you said $400 million and some odd. What's your cash burn and how are you managing that and sort of like...

Tycho Peterson

executive
#16

Yes. So, we had -- first quarter is always the biggest quarter for cash burn, so it's 56. And then what we've said is it's going to average 40 per quarter going forward for the remainder of the year. And then next year, it should be less. I mean this is a priority. And so, we'll continue to kind of bring that burn down until we're profitable.

Chad Robins

executive
#17

In terms of the cash runway, though, I mean, we've got over...

Tycho Peterson

executive
#18

Over 10 quarters...

Chad Robins

executive
#19

Over 3 years of cash and a little more than 3 years of cash on hand. And we've talked about kind of EBITDA profitability by 2025 and cash flow breakeven by 2026. So again, I never want to say never, but it's likely that we won't have to raise equity capital again before we get to kind of cash flow breakeven.

Derik De Bruin

analyst
#20

So, can we talk a little bit about the clonoSEQ business and you're looking at volumes growing 50% this year. How do we sort of see that growth rate flattening out? And it goes through also -- or how is that growth rate trajectory from here? And can we also talk a little bit about the size of that market opportunity and how penetrated you are in some of these indications and sort of like what the outlook is for that business?

Chad Robins

executive
#21

Yes, sure. Just talking about 2023, we've committed to over 50% volume growth in tests delivered and I can reaffirm that commitment today. We haven't yet given guidance yet moving forward beyond 2023. But I can tell you that we expect to have robust growth going forward. We are just kind of -- at the tip of the iceberg of kind of cracking the penetration. Overall, our penetration is 5% of the cancer patients who are eligible for clonoSEQ test. However, within that, by indication, there's a pretty significant variation. If you look at kind of our ALL penetration, it's close to 20%, whereas our multiple myeloma is about 7%. And we're just starting out in diffuse large B-cell lymphoma, which is around 2% or 3% as a CLL. So, we've got kind of a pretty significant growth ramp ahead of us and we paved the way kind of laid the foundational elements with kind of reimbursement with FDA approval where appropriate. I think it's really important that we're embedded in almost every pharmaceutical trial that is looking at a heme malignancy drug that is lymphoproliferative or where our test applies to that trial. So -- and this is perhaps most important, it is by far the most sensitive and specific test to monitor MRD in heme. So, our physician in kind of heme MRD, now it's just really an execution story. With all that, all those kind of competitive moats, we have to -- there's a couple of things that we're doing with related to kind of workflow and Epic integration. There's -- Epic integration is really important. Our first kind of beta testing is going to happen kind of next quarter. And then by the end of the year, we'll roll out and kind of call it 6 to 10 sites. So, you won't see a major lift in terms of penetration this year. But in 2024, you were expecting kind of that Epic integration along with other workflow enhancements to be a big part of the strategy as well.

Derik De Bruin

analyst
#22

And going along, you mentioned clonoSEQ being the most sensitive and out there. So, like what else -- I mean, you hear a lot on MRD, although it's in solid tumors though it's probably cancer recurrence as opposed to MRD if you want to get technical with it. But how should -- but what about the companies moving to heme malignancies and how are they booking out? So basically, what's the competitive moat? Are you worried about other competition coming into this market? I mean how big of a commercial barrier have you built around this area.

Chad Robins

executive
#23

Again, within hematologic MRD, heme MRD, there's a very significant competitive barrier in moat that we've built that it consists of payer coverage, your pharma penetration, the -- basically, having all the evidence. I mean, we have over 150 publications that reference clonoSEQ. It's the clinical utility evidence. There's just a tremendous amount of -- to get into this business now and to be able to penetrate the sensitivity and specificity of the underlying technology is really hard. So, our true competition is replacing -- well, I'm going to put in quotes, standard of care assays right now. So, the tests that doctors are using to look at minimal residual disease or other tests to be able to kind of monitor when -- what the kind of burden of cancer is. So as an example, when we look at ALL, they're using -- we're replacing flow cytometry, okay? When we look at multi myeloma, it's the m-protein test. In diffuse large B-cell lymphoma, which is lymphoma, they were looking at a blood test to replace PET scans. So, there's -- that is really our competition. That being said, there are certain pockets where companies are upstarts and/or existing companies that have some efforts to try to either look at MRD in certain indications. And we keep a very close eye on them and kind of monitor the competitive landscape.

Derik De Bruin

analyst
#24

So, interesting -- so flow and m-protein and PET scans. I mean these are all things that -- in hospital labs. So, are you finding any resistance from hospitals not wanting to send out revenues to you?

Chad Robins

executive
#25

So yes, it is interesting, but we've been fighting this battle with academic kind of medical centers for years. And what happens is it's driven by the HemOnc, right? The clinician and the clinician band together and say, look, this technology is that much better. We can't afford to be sending our samples to the basement to look at an analog picture on a flow cytometer versus a digital readout that counts cancer cells because just to be very clear, what our technology does is able to very accurately to 1x10^6 to be able to count one cancer cell in every 1 million healthy cells. And so it's a tool that the clinicians are clamoring for. And yes, over time, it's been a battle, but we've kind of done that hand-to-hand combat and won time and time again. I'll give you a great example. Memorial Sloan Kettering is kind of one of the last holdouts, and we've -- we're just at the point now where we've cracked that institution, but it's been a long battle with the pathologists in the institution.

Derik De Bruin

analyst
#26

Yes. I spent 6 years there. So yes, I understand completely what you're talking about. So, how should we think about -- do you have enough salespeople that are out there? And just like do you need to put more feet on the street to sort of drive this? Or is it just a matter of the data coming through? It's like what else -- what else can you do to sort of accelerate the...

Chad Robins

executive
#27

And maybe a couple of things I left out. I mean we do have -- we've got the data, we have guidelines inclusion. Right now, we're good, Derik. And we have about 70 sales people. Those are broken up between kind of 40 being what we call DHS, is Dedicated Hematology Specialists that target the community oncologists, which is kind of our fastest-growing segment and then 30% focused on our academic medical centers, which their job is to kind of drive volume within big cancer centers within established accounts. But in terms of coverage, we're always looking at kind of sales force productivity, geographical kind of productivity. But right now, I think from an absolute number of people, right -- unlike solid tumors like the HemOnc market can be covered, we've got a very, very professional experienced sales force. And then you can really cover the market with that for now.

Derik De Bruin

analyst
#28

What's your new position adds on any given quarter? Like how many -- what's your new to Adaptive versus repeat customers?

Chad Robins

executive
#29

Just in terms of kind of percentage or on a nominal basis?

Derik De Bruin

analyst
#30

Just percentage is fine.

Chad Robins

executive
#31

On a percentage basis, we're probably adding, on a physician basis, it's 8% or 9% on a quarterly basis.

Derik De Bruin

analyst
#32

So, can we talk a little bit about the T-Detect franchise? I think people have been sort of waiting for how that's going to expand. And you started to do some things in line, you pulled back and start to do some stuff. Can we sort of talk about how that's going to evolve from here? And when do we -- the platform has always intrigued me because it's got the opportunity to see so many different diseases in one sample. So, when we sort of like get to that first real product that's out?

Chad Robins

executive
#33

So just recall, last year, we made the strategic decision that we were pausing on the commercialization of T-Detect as a clinical diagnostic for now. But we weren't pausing on mapping T cell receptors to clinically relevant antigens. You may ask why we're doing that. And I'll give you the answer, which is that data is incredibly valuable if you look at a patient stratification or enrichment strategy in a clinical trial. An example of that is we publicly announced we're working -- our first 2 autoimmune kind of target discovery is around multiple sclerosis and inflammatory bowel disease. So in MS, if you're able to enrich for patient population by knowing the responders or the potential responders based on this biomarker, then your probability of success in a clinical trial goes way up. I mean this is -- this was kind of the page out of Prometheus' playbook. Obviously, congratulations to them on a very significant recent acquisition. But they were a diagnostic company for many years and then kind of synergy pivoted to therapeutics. They didn't toss their diagnostic data, but they used it to enrich for that patient population and had really a beautiful Phase IIb data in the IBD space. So, that is exactly what we're doing. And we're doing that essentially indication by indication. At the same time, that underlying data is going to be, I think, incredibly valuable down the road for diagnostic purposes as a clinical diagnostic. And if you look at all that's going on in kind of the AI space, that data to be able to train models has, I think, a tremendous amount of value.

Derik De Bruin

analyst
#34

So just bouncing back, I meant to cover some questions on coverage and of clonoSEQ and sort of where are you or are you fully covered and...

Chad Robins

executive
#35

Well, we have...

Derik De Bruin

analyst
#36

[ Single ] payer versus private payer, obviously, yes.

Chad Robins

executive
#37

So, not fully covered in private, but it varies by indication. We have about 260 million lives in ALL in myeloma, about 190 million lives in CLL. Medicare does cover the test and ALL, multi myeloma, CLL and diffuse large B-cell lymphoma. And we're growing coverage in the first 3 of those, ALL, MM and CLL with the private payers. Diffused large B-cell lymphoma, although covered by Medicare, we just started really kind of those conversations with private payers to cover the lymphoma MRD test.

Derik De Bruin

analyst
#38

And for Medicare, it was originally like for 4 tests, I believe, right?

Chad Robins

executive
#39

4 tests around $1,700 a test.

Derik De Bruin

analyst
#40

Right. And so is it now going to go to more one-off -- so let's say a patient has gone for the 4 test, is it going to become more of a one-off?

Chad Robins

executive
#41

Yes. So, we are -- we probably -- we're in conversations with Medicare about after those 4 tests about having a digital kind of test on a recurrence basis one by one. Not yet approved just to be clear, in discussions.

Derik De Bruin

analyst
#42

In discussions, got it. And you have about $400 million in MRD milestones just given some of your pharma partnerships and things like there. Can you sort of talk about your visibility on those? How do you expect those materialize over time?

Tycho Peterson

executive
#43

I can take that. So, what we've guided to this year is kind of mid-single-digit milestones. Most of the Street's got that in the back half of the year, either $2 million or $3 million in third or fourth quarter. And then what we said on the earnings call is, next year is going to be quite a bit bigger. What we do, though, if you look at that $400 million, we assume to recognize those over the next 5 to 7 years, we probability adjust 30% to 50%. But next year will be a bigger year for milestones based on kind of what we know about trial readout. All the milestones so far are on secondary endpoints. So, there's upside to the extent the FDA endorses MRD as the primary point down the road.

Derik De Bruin

analyst
#44

Any questions from the audience. No. Is there? No, it is not. Okay. So, how is your -- speaking of pharma partnerships, have you seen any -- like to ask you obligatory small-cap biotech question and emerging biotech question. I mean, I would assume you haven't really seen any impact of that per se, but can you...

Tycho Peterson

executive
#45

I mean, first of all, our exposure is relatively low. It's mid-cap biotech, right? What we've -- we haven't seen anything in immune medicine. And then if you kind of look at the MRD part of the world, I think if Nitin were here, he'd say there's noise out there, but nothing we're seeing certainly no our numbers. I mean, our volumes have been great. It hasn't really impacted any of the MRD trials up till date, up till now, and it doesn't look like it's going to. But there is some reprioritization of pipelines that we're hearing about as we go out and have some of those discussions. We did factor some softness into our guidance. I mean this has been a theme really kind of going back to last year. So, as we thought about guidance, we also assumed that part would be a little bit smaller. But importantly, our overall mid-cap biotech exposure is small and similarly, we're not seeing anything with pharma around IRA.

Derik De Bruin

analyst
#46

That keeps coming up with this. People saying there's some -- or you haven't seen any sort of like pipeline reprioritization or anything like that?

Tycho Peterson

executive
#47

Not in heme, right? I mean, certainly, in other areas. But it's not -- yes, I mean, on the MRD side. And then on immune medicine, we're not seeing it.

Derik De Bruin

analyst
#48

The -- so you did the big -- the IND, so that's the big milestone for this year that was sort of come out with it. What else is sort of coming up on the milestone chart when you sort of look into '23?

Chad Robins

executive
#49

In '23 milestone from the immune medicine business?

Derik De Bruin

analyst
#50

Just in general, sort of like catalyst milestones, which wins were sort of like data points, I mean.

Chad Robins

executive
#51

So, we're looking at data readouts in the MRD business. Both in terms of kind of blood-based testing and looking -- comparing blood test versus marrow in multiple myeloma and in comparing PET scans versus a blood test in diffuse large B-cell lymphoma that should come out kind of around the end of the year in the ASH time line. Second is Epic integration. We should be able to, hopefully, by next quarter, be able to announce that we've kind of implemented Epic into kind of a beta -- a couple of beta testing accounts. On the immune medicine side of the business, as we've been talking about, we're hoping that we will have identified a novel target in an autoimmune disease. And again, the ones that we've talked about publicly are multiple sclerosis and IBD. So, there's quite a bit there. At the same time, we're putting in place on the Genentech partnership for the personalized program, a full end-to-end kind of clinical pipeline to be able to identify patient-specific T cell receptors from patient-specific mutations and that entire kind of workflow will -- should be optimized and ready for kind of IND readiness, clinical readiness by the end of the year. So, we got a significant amount kind of coming up.

Derik De Bruin

analyst
#52

And what's your expectations for volume on the Epic and just like how they could impact those volumes?

Chad Robins

executive
#53

Well, we haven't -- I'm going to answer this in a somewhat generic way and I apologize because the reality is we don't know, and we haven't given guidance around it. What Epic says, and I have different Board members and others that have implemented Epic, they claim kind of that Epic integration kind of increases volumes by upwards of kind of 50% on certain accounts. I want to temper that with the fact that just because we implement Epic on our side and all of our workflow is done every account has to turn it on one by one. You have to go to the IT administrator, get on their schedule. They got -- it's a 24 to 48-hour kind of turn on and then you've got to kind of get that kind of workflow implemented within each institution, which is why we've said just in terms of volume, I talk about it more in terms of the number of accounts that we've turned on, which is a couple beta tests next quarter and then call it 6 to 10 by the end of this year, and then we'll start kind of rolling on, on a quarterly basis next year. And that's also where we hope to see kind of that significant volume uptake. And when we look at -- we're obviously growing off a much larger base. If we increase volumes by over 50% test delivered this year, then we're starting at a higher base, and we're looking for another significant increase next year without giving out a number. To do that, there's 3 things that need to happen. Epic integration has to go well. We need to continue to -- with our DLBCL launch because we talked about that being a really 2024 event with an increased volume. And the third is this continued shift to blood-based testing. And this blood-based testing ultimately means you're testing each patient more time points per patient because it's obviously easier to get a blood test than it is to get a bone marrow. So, those kind of 3 different factors along with continuing to develop the clinical evidence, getting payer coverage. This is now just -- again, hopefully, I'm imparting on you that MRD is just -- and I'm just talking about clinical business, it is just an execution, blocking and tackling, doing everything we need to do, and we are on kind of the top line side. And at the same time, the efforts that Tycho mentioned about really streamlining workflows and cutting costs out of the system so that we run this business like a machine. That's a clinical business. And then on MRD Pharma, it's just continuing our lead and penetrating accounts and showing that our value proposition is stronger than anyone's out there for being embedded and delivering high-quality FDA-regulated robust data to pharma companies in their clinical trials.

Derik De Bruin

analyst
#54

Got it.

Chad Robins

executive
#55

Do you have a question back there?

Unknown Analyst

analyst
#56

I'll just ask my 2 questions, right, they're not related. One on Genentech, how long do you expect them to take to review your packages, the new packages that you've submitted to them? And then on the MRD testing for -- in terms of reimbursement, commercial reimbursement, is there any guardrails in terms of how many times a patient can be tested, anything like that in your reimbursement contracts?

Chad Robins

executive
#57

I'll take the second one first because it's a lot easier. And I'll just say no. There are no guardrails. Whereas in Medicare, there are -- right now forecast and we're working on getting test reimbursed after that. In our commercial payer contracts, it's on a per test basis, granted some of them ask for prior authorization and there's other hurdles to get across, but it is not limited. It's only limited by medical necessity, which is built into the contracts. With respect to Genentech, I really don't have a -- I don't have a time line for you right now.

Derik De Bruin

analyst
#58

So, as we sort of, coming down to the bottom of the hour here. You know my standard closing question, right, which is what's underappreciated about Adaptive, and we can punt that one to Tycho, he's ever been -- he's never had the pleasure of answering one of those questions for me.

Tycho Peterson

executive
#59

Look, I think we have half of our business that's pretty well understood. People get MRD, they get pricing, volume, penetration, right? I mean these are well understood dynamics. I'd venture to say very few people understand immune medicine. Some of that is on us. We haven't explained a lot in terms of where we're going with our technology. We have to prove it out with other deals. Obviously, getting the Genentech IND was a big first step and you'll see other proof points, hopefully, before too long, but that's, I think, the biggest part of the business that...

Chad Robins

executive
#60

I mean I think Tycho said it really, really well. And I think -- we've got some -- today started, I think the -- hopefully, the public activation and understanding that Genentech is on track, but we also have a tremendous amount of work going on and data that's emerging that's looking really, really good and then our internal programs. And these are novel ways to use immune receptors therapeutically and to use our technology to discover new targets in hard-to-treat autoimmune disorders, which, gosh, as we know the world needs. So, stay tuned.

Derik De Bruin

analyst
#61

I mean, If I can add my 2 cents, I think it's just we spend so much of our time talking liquid biopsy and other type of stuff. Just you're sort of an outlier in terms of thinking about the diagnostics of the universe, right, in the sense of you have to do work to understand your platform. I think many understand the business might be, but I think for your drug development program, you definitely have to do work to understand that. I mean, immunology doesn't -- immunology isn't easy.

Chad Robins

executive
#62

It's very, very complicated. But it is interesting, Derik, you mentioned kind of liquid biopsy. At the end of the day, our MRD does -- that is, it is a liquid biopsy test. Maybe perhaps we can do a better job kind of branding and kind of fitting into that kind of category. But we're just happen to be kind of carved out in the heme space and the leader in the heme space in liquid biopsy.

Derik De Bruin

analyst
#63

Yes. I mean, just in the sense that like there's so much oxygen that's getting sucked up from like [ colon ] cancer screening and that type of stuff and that's where all my questions come in with. And I just don't bet I mean I think when anyone is doing any work on the diagnostics space, that just seems to be where the focus is because it's -- it seems like there more actual items on it. But -- that's just a matter of time for you guys.

Chad Robins

executive
#64

Yes, it is.

Derik De Bruin

analyst
#65

So, it's data, data. All right. Thank you, everybody. Thank you, and...

Chad Robins

executive
#66

Thanks, Derik. Appreciate it.

Tycho Peterson

executive
#67

Nice question. Thanks.

Chad Robins

executive
#68

Thank you.

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