Exagen Inc. (NASDAQ:XGN) Q4 2023 Earnings Call Transcript

Andrew Brackmann: Hey guys, good morning. Thanks for taking the questions. Maybe on the new markers here, can you maybe just talk about some of the specific steps that are needed to actually include that in the test here in the back half of the year? And I guess how should we be thinking about investment in the further study to really highlight that benefit that these might be able to provide to patients? Thanks.

John Aballi: Hey, Andrew. Good morning. Great question. Appreciate the opportunity to expand. So, these are lab-developed tests, meaning there’s not IVD, FDA-approved kits available. We’re validating these analytically as well as clinically in our lab and running those experiments. We’ve already performed an initial clinical validation. We have the assay up and running in our research laboratory. We’re moving it and getting it clear ready. And so, some of those aspects require really getting it to a point where it operates at scale. So, better processes around controls. We manufacture our own controls, for example, better processes around batching, workflow. There are some IT and software changes which really need to be made to handle it at the demand level we expect here later this year.

And so, it’s mostly operational at this point as opposed to technical feasibility, and we’re well past that stage, which is a big reason why we’re talking about it externally. And from a clinical validation standpoint, we have an abstract out and we’re working on a formal publication likely to come later this year as well. So, the initial steps have been taken. We’re very confident with the performance of these markers. We have the appropriate supplier agreements and everything in place so that when we do ultimately go live, we’re in good shape. Another key component to this, when you bring novel biomarkers to clinical practice, there’s a huge educational burden required. And so, our commercial teams have been preparing actually for the last several months in this regard, a lot of planning in terms of what materials will be needed, quite a bit of voice of customer, how do we actually present the results in a manner which is easy to digest.

Clinicians are busy, but also which allows them to act quickly. So, most of that has been completed. It’s executing on it. So, a lot of the planning phase is done. There’s still caveats to that, but quite a bit as that of that is done. And then we just need to execute. So, we’ll have to actually complete our formal CLIA validations on the analytical side. We’ll get our publication out. We’ll refine our training of our entire field-based team, and then we hope to launch sometime late into Q4. So, that’s really what’s left. And like I said, from a risk standpoint, the way we view it as a technical risk of the assay working or panning out from a clinical standpoint, we’re past that in our expectations.

Andrew Brackmann: Perfect. And then maybe just switching gears, going back to some of the commercial activities, John, that you mentioned around sort of hurdles or requirements to really do business in this arena, can you maybe just sort of talk about some of the specific tactics that your team might be able to deploy to either incentivize that behavior from physicians to allow them to gather that data or sort of reduce that burden for them? Thanks.

John Aballi: Yes, it all comes down to reducing barriers. Obviously, you have to understand your practices at a very deep level to understand where the pain points are. I think a big part of change management is really explaining the why behind those changes. And to be honest with you, a lot of clinicians don’t really understand the revenue cycle side, what’s being asked by insurers when you’re dealing with proprietary markers and having to prove clinical utility of tests or tools. And so, explaining that to them takes time. Some people want to listen, some people don’t. We try very hard not to make our problems our customers’ problems. That’s pretty basic business tenet. But from our perspective, when you’re able to explain the why, a lot more downstream goes smoothly, right?

You get the buy-in. So, we worked hard to set ourselves up in that regard. We’re very transparent with our internal team, and that leads to transparency externally. And so, as we work through some of that explanation, then it comes down to execution. And what I mean by that is, each practice is different. Some have – in some cases, the phlebotomist handles most of the test processing within a clinician’s office. In some cases, it’s front office staff. In others, it’s nurses, and in some it’s the actual clinician. So, you can’t have a one size fits all approach to this. You have to tailor it into each additional – into each practice. And so, there’s some customization of processes there, but that makes it easier on the actual clinician. Also, when we’re explaining the why, some of this is training on what insurers are actually looking for.

Insurers are really looking for was this test – what was the presentation of the patient which justified ordering of the test, and then how was the test used, and how did patient management change after the test was ordered and results received? So, it all comes down to documentation. And unfortunately, that’s – yes, that can be a bottleneck for some practices. And so, explaining that, talking through exactly some of the feedback we get from insurers has proven helpful, but a lot of this takes time, right? And it’s a cyclical feedback loop, meaning we work with different clinicians. We set expectations. We help them understand the why, and then when we put it in practice, that’s version one, and we ultimately have to get us to a successful version.