Adaptive Biotechnologies Corporation Common Stock Morgan Stanley 24th Annual Global Healthcare Conference

Yeah. Relevant today and kind of unexpected, we had a major guideline update in multiple myeloma, and I am actually going to look at my notes because this came in from my team recently. The NCCN multiple myeloma guidelines were updated, but they now include a dedicated page for MRD testing. This is very similar and parallels the structure that they do in ALL guidelines. Really what it does is it signals that the panel views MRD as an assessment as essential for management of patients with multiple myeloma. More specifically, the recommendations for MRD said that MRD is recommended using an FDA-approved assay such as clonoSEQ or flow cytometry. This is the first time that clonoSEQ is being specifically named in the NCCN guidelines, and it is actually pretty rare that a test manufacturer is named in guidelines. So we are pretty excited about that.

The second thing that is really important is that while 10 to the minus 5 minimum sensitivity is recommended, it is now stated that 10 to the minus 6 is stated as preferred. This is huge because that is what clonoSEQ does, is 10 to the minus 6. Then it gives you all of the different points throughout the patient care continuum that clonoSEQ should be used. The one that I want to highlight specifically is at regular intervals during maintenance and surveillance. MRD assessments during surveillance, this is an entirely new thing. So I will stop there. Multiple points of those guidelines are specifically what we have been talking about, what we think is critical for clinicians to use on their patients for clinical decision-making, interventionally to guide treatment decisions. So we could not be more thrilled and frankly, surprised at how comprehensive this update was for us.

Yeah. It's interesting because as soon as we did this, we did this a few months ago, we had an updated TAM number, increasing the TAM by $800 million. Frankly, we knew when we put it out, and that goes from 2.5 tests to 3.5 tests per patient per year on the overall addressable market. This, I would say, at the very minimum, kind of reinforces that, but it's also going to allow us to dust off some of those assumptions. A lot of these things work together. It also called out peripheral blood for the first time, that you could use peripheral blood in multiple myeloma assessment. This was in the guidelines, and we've been talking about increasing the use of peripheral blood over bone marrow in multiple myeloma. All these things work together to talk about more testing per patient per year.

The net is I think this is a nice opportunity to look at a further TAM expansion.

Corina and Kyle can help you on that.

Yeah. First, clinical volumes continue to be great. We're really excited about what we're seeing and what we continue to see into this quarter. It's been really nice. One of the components of clinical volume that I think was, I will say really of surprise, that we're just really excited about is if you look at the number of clinicians that are clicking on the repeat ordering button in the Flatiron ongoing EMR, I know we'll talk more about it later, the serial testing's been a really nice source of upside for us, and the compliance rate on that is also extremely high. Other areas of upside, our pharma business is really doing well.

If you look at the ODAC decision in 2024 that was codified into draft guidance earlier this year saying that you could use MRD as a primary endpoint in multiple myeloma, that's not only had an impact on the myeloma business, but that's also bled over to the other I said bled over, no pun intended, in heme malignancies. But it bled over to the other indications, particularly in ALL and CLL. One area that we're monitoring is if you look at our related to volumes is our ASP. We need that increasing volume. That increasing volume may put some short-term kind of transitory pressure on ASP. There's a lot of ways we're solving it, and we'll talk about that.

But overall, I should also say we have a submission into MolDX to increase the number of tests per the episode, which will immediately alleviate that pressure, and we're expecting to hear back relatively soon on that. But overall, the business is in really strong shape. Volumes, pharma, et cetera, everything's moving up and to the right.