Heartflow, Inc. Common Stock Wells Fargo 21st Annual Healthcare Conference

You got it right, though.

Yeah, great. So thanks, Larry. It's a pleasure to be here, and you did pronounce my name correctly, so thank you for that. I've heard much worse. Right, Vikram?

Yeah. Okay, I'll give you a quick overview, and then we'll go into the Q&A here with Larry.

And obviously with me are Vikram, our CFO, and Campbell, our CMO. Both Campbell and Vikram will share in this discussion. Just to ground everybody, for those that aren't totally familiar with HeartFlow, we're an AI company. We use AI to diagnose coronary artery disease. We're focused solely on coronary artery disease. We've been around. The company was founded in 2010, and we just IPO'd about a year and a half ago. Our current focus right now is the symptomatic market. Okay. The symptomatic market's about a $5 billion TAM, and we've had good commercial adoption through this, but we still have a tremendous amount of upside relative to penetration just in this TAM in of itself.

We've got a couple very attractive growth drivers that I'll speak to. One is Plaque Analysis, and this is Plaque Analysis for the symptomatic patients, and I'll talk about that. That growth wave is underway, so to speak. Then, on the near horizon here, and Campbell will speak to the clinical plan on this, we have a very attractive adjacent TAM of $6 billion, and that's high-risk, asymptomatic patients. So you'll hear themes of this as we discuss, and I presume I'll get some questions as well. I won't get into the financials. I think everybody's probably familiar with that. The one thing I'll say that is core to our story is this theme of data. Okay. This is both clinical data that we really believe is the currency of the realm in working with cardiologists.

We have over 625 peer-reviewed publications, thanks in large part to all the work that Campbell's done over the years. Then the other type of data we have is the data that we use to train our AI algorithm, and we have a proprietary database of over 200 million annotated CT images. We use this data to improve our current algorithms as well as to create new ones. So both of those are really important components of the story here. To ground everybody, so put your brain back in the symptomatic world for a minute, to ground everybody on the problem that we're trying to solve.

Right now, if you're a patient and you have chest pain, dizziness, shortness of breath, some type of a symptom, ultimately, you find your way to a cardiologist, and that cardiologist diagnoses you not by looking at the actual disease, but instead off of symptoms and surrogates. That's the standard of care, and the standard of care has poor outcomes, as illustrated by half of all heart attacks are a surprise. Okay, and that's well understood. Very high false positive rate. Over 55% of patients end up in the cath lab for an intervention that they don't need. Similarly, 30% of patients are told they're okay, only to go home and have an event. So there's a real problem here, and there's a real opportunity to create a new standard of care. We at HeartFlow think we play an important role in creating this.

Okay, in the tail end, just at the end of 2021, here in the U.S., CCTA, so coronary CTA, was put in the guidelines as a level 1A test ahead of all other alternatives. HeartFlow was put in as level 2. This isn't just in the U.S., this is around the world in Europe, U.K., and Japan as well. The clinical data that substantiates this as better medicine is well understood, and we're working to change behavior patterns and practice patterns to change this standard of care. The company's had good success up to now, but we have a lot of road still to pave here. This slide illustrates our platform. We have a holistic AI platform that's end to end, regardless of where the physician needs us on the continuum.

We have a tool that we provide for all CCTAs to help CT readers read it more efficiently and with less variability. We have separately reimbursed FFRCT and Plaque Analysis products that are separate reimbursements for our customers, separate revenue streams for us. We've just integrated our staging platform that allows physicians to manage patients with plaque relative to their risk level. Then we're launching, in the process of launching, what we call a Heartflow PCI Navigator tool that's intended to bring the best of both worlds from both Plaque Analysis and FFRCT into the cath lab for interventional cardiologists. Everything we do is backed by clinical evidence. We believe in the power of prospective clinical evidence, and the truth, ultimately, we believe, will differentiate us more than anything else out there.

We integrate seamlessly into electronic medical record systems and PACS systems, and we like to do everything we can to make our physicians' lives as easy as possible. Again, just relative to the addressable markets, in the near term, we've got this $5 billion U.S. TAM comprised of about $3 billion for FFRCT, $2 billion for Plaque Analysis, and we're lightly penetrated. So there's a lot of headroom here to continue to grow and drive a new standard of care. Then I'll talk about our plans for asymptomatic here in a moment. Plaque Analysis, as I mentioned, in the symptomatic world, this is our current growth driver. There's been a number of catalysts in 2026, a couple or one still to come. At the start of 2021, we had a Category I code take effect. That was quite important to us.

Just last July, as I mentioned, we've launched our Plaque Analysis staging tool into our platform. Then in November, we have our one-year data from our DECIDE trial that's reading out. That's going to show both change in LDL as well as outcomes as measured by CV and MACE. So that's an important endpoint to get out in the market. You can see the commercial metrics. We started the year with only about 500 Plaque Analysis and about 500 accounts. We're going to end the year north of 1,200. So really good adoption there. We're guiding to a midpoint of about $30 million in Plaque Analysis revenue this year. This is exponential growth relative to what we did last year. We only did about $1.5 million last year. Commercial coverage is coming online really nicely.

We've got still one big payer left out in front of us in Anthem and a long tail of regional payers. We're very pleased with where we are relative to commercial coverage. Again, that's helping drive adoption as well. Plaque, we believe, again, in the power of prospective evidence. We have that proving our accuracy. We have that proving our reproducibility. We have our DECIDE registry, which is 23,000 prospective patients in a prospective registry. That's reading out the one-year outcomes, again, reading out at the end of this year. These are the 90-day endpoints. We continue to educate the market on how to use Plaque Analysis. One important element of this, again, is our staging system. This is a staging system of 23,000 patients followed up to 16 years. You can see how the risk curves spread by stage.