GRAIL, Inc. Common Stock Morgan Stanley 24th Annual Global Healthcare Conference
Review the key takeaways and the transcript of this earnings call.
- GRAIL reported a 35% year-over-year growth in test volumes, driven by education of physicians, health system adoption, and digital health channels.
- The company presented two key studies at ASCO: the NHS GRAIL randomized control trial and the US-based Pathfinder 2 trial, showing reduction in stage 4 cancers and detection of more early-stage cancers than existing NHS screening combined.
- GRAIL's test demonstrated a positive predictive value over 60% and about 60% sensitivity for the 12 cancers causing two-thirds of mortality, detecting both screened and unscreened cancers.
- The company emphasized the importance of physician experience in driving routine test use and highlighted workflow improvements such as integrations with Quest, Athena, and Epic to ease ordering.
- FDA approval is expected based on 12-month follow-up data from Pathfinder 2 and NHS GRAIL, focusing on safety and efficacy with high specificity (>99.5%) and positive predictive value.
- GRAIL has ongoing conversations with CMS regarding coverage, including the REACH study in Medicare beneficiaries, and expects these to accelerate post-FDA approval.
- The company noted existing limited coverage through employers and TPAs and plans to expand commercial payer engagement after FDA approval.
- Large health systems like RUSH, Mayo, and Dana-Farber have adopted or published experiences with GRAIL, supporting clinical evidence and adoption.
- GRAIL differentiates itself by the breadth and depth of its data, FDA approval, and external validation from health systems.
- The company is advancing the test with iterative improvements, aiming to move from a snapshot to a dynamic 'movie' of cancer detection, improving performance, throughput, and cost.
- Internationally, GRAIL is partnering with Samsung to access South Korea, Japan, and Singapore markets, leveraging Samsung's brand and local infrastructure.
- Management highlighted the importance of early detection to enable access to novel therapies and reduce mortality, viewing GRAIL as at the beginning of a long adoption curve.
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Transcript
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Perfect. I think we can get started. Kallum Titchmarsh here from the Life Science Tools and Diagnostics team at Morgan Stanley. Thank you all for joining us today, joined by Eric Fung, Chief Medical Officer at GRAIL, for a fireside chat discussion. Just before we get started, for all disclosures relating to this presentation, please see morganstanley.com/researchdisclosures. Eric, maybe for those that haven't had the opportunity to meet you, could you just tell us a little bit more about yourself and your involvement with GRAIL during those 9 years I think you've been there?
Yeah. Well, thank you, Callum, and thanks for the Morgan Stanley team for having us here. I'm Eric Fung, Chief Scientific Officer for GRAIL. I've been at GRAIL, as Callum said, for 9 years. I've really spent my life, my career, developing novel diagnostic tests, and when GRAIL was first announced in 2016, it was really fascinating to me, this idea that you could screen for cancer using just a blood draw. You may recall at that time, though, it was about the time that Theranos was really very much in the news. Talking to my colleagues, there was a lot of, "Can they really do that? Is it real?" I decided to take the leap, and I've been working at GRAIL ever since to really develop the clinical evidence program, really bring the science to bear, and it's been really paradigm-changing.
Perfect. GRAIL's obviously spent a lot of time and dollars throughout that period building the evidence and infrastructure behind Galleri. Where do you think the company is today on the path from a kind of niche early adopter product to something that could become more routine in that preventative care?
There's several steps along the way. As you point out, early adopters are really important, but obviously clinical evidence is the single key driver. That clinical evidence opens many doors, and I think the three doors that are really important are broader adopters from early adopters to people who are really evidence-based, and that includes KOLs and health systems and so forth. The second is FDA approval. FDA approval is really a stamp of an external party validating and really having reviewed the data. The third is coverage. Coverage is ultimately the end game when it comes to being able to offer a test that widely.
Another strong quarter recently, I think Galleri volumes grew 35% year-over-year. When you deconstruct that growth today, what are you focused on the most between adding new prescribers, driving utilization amongst physicians, setting up those digital health channels as well, which I think have been pretty important.
Right. When we think about who's ordering the test today, you have the individuals who are dabbling, so to speak, then you have high volume users, health systems. Our goal is really education is key. The dabblers, they're usually ones that patients come to them and say, "Oh, I've heard about this test. I want to take it," but they're not the ones who will actually drive it. Then there are the individuals who are high volume orders because they have actually seen the data, understand the data, then health systems which are at an organizational level are ready to adopt the test. All of that requires at the root of it an understanding of the test.
Our field team is out there educating physicians about the data, about the nuances of what makes a multi-cancer early detection test clinically useful, the benefits, and we put that together. The other element that's really important is making it easier for the test to be offered and to be deployed, so that's where a lot of our partnerships come into play.
A lot of data as well to discuss. What's feedback been since ASCO from the oncology and PCP community on the recent Galleri data, NHS, then the PATHFINDER 2 as well?
We were fortunate enough at ASCO to have two podium presentations. One was on our randomized control trial done in collaboration with NHS England. That study is called NHS-Galleri, and the other podium presentation was our U.S.-based multi-center prospective trial called PATHFINDER 2. NHS-Galleri had the headline news that we did not meet our pre-specified endpoint of a reduction in Stage III and IV. The nuances underneath that, and what we were able to present at ASCO was that we actually saw a reduction in Stage IV cancer. When the headline is we did not meet a reduction in combined Stage III and IV, underneath the hood is we actually did see a reduction in Stage IV. That was offset actually by an increase in Stage III.
This told us a lot about the biology, which is that there's actually a lot of Stage III cancer that is in people who don't suspect it, asymptomatic individuals, and that Galleri was able to detect them. If you look at the next layer of data, the reduction in Stage IV, the reduction in emergency room presentation, the fact that Galleri detected more Stage I and II cancers than all of the NHS guideline-recommended screening combined, that's really compelling data. Our field team has been taking that data and showing that to KOLs, to PCPs, and to health system executives, and other stakeholders to really show them that the next layer of the onion is really compelling data about the performance of the test.
The PATHFINDER 2 really is a great example of how this test performs very similarly in two different populations, and that level of validation is one that I think people who really understand the data come to appreciate.
Could you give us a little more context on the cancer types where you saw perhaps the best performance and maybe those that perhaps were lagging?
This is a conversation that goes on in the MCED field quite a bit, which is looking at aggregate performance over all the cancers in a population versus cancer by cancer. We've been focused because it is multi-cancer early detection, because we detect a shared cancer signal across all the different cancer types. We've been focusing on that aggregate signal and shown that we have a very high positive predictive value north of 60%, which is 10 times greater than single cancer screening. We show that our sensitivity for the 12 cancers that cause two-thirds of mortality, about 70% of the cancers we detected are in those cancer types and about 60% sensitivity. The other way people think about it is, well, maybe you should separate out cancers that we screen for, like breast, colorectal, and separate those from cancers that we don't screen for.
But in point of fact is we detected a large number of breast cancers and colorectal cancers and lung cancers because those are cancers that are not always detected by screening for a variety of reasons. People are not up to date with their screening. There are interval cancers. There are people who are survivors. More lung cancers are present in people who are not eligible for screening than who are eligible for screening, and those are ones that we can detect as well.
Very helpful. What do you think distinguishes a physician or practice that writes one to 2 Galleri orders from those who incorporate it routinely into their practice?
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