Exact Sciences Corporation (NASDAQ:EXAS) Q1 2024 Earnings Call Transcript

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And then, just as a clarification, I mean, I think of our models and prior to this earnings — sorry, prior to this print versus right now, I mean, we really aren’t going to change very much, right? You’re not really asking us to change almost anything on the initial guidance, right? So anyway, that’s just it?

Jeff Elliott: Yes, this is Jeff. I’ll start. Agree, we maintained guidance. Look, we’re only 90 days in, a long year. We feel very good about our ability to achieve this year and the longer-term goals. I think we did articulate the comps very challenging in the front half. They get easier as the year goes on. We talked about the investment already starting to see the impact in April of the marketing investments. The sales rep investments, very confident there that will play off kind of mid-year and beyond. Again, we’ve done this before. We know the reps carry a very strong return, and we’re looking forward to seeing that. And then the care gap program, Kevin gave some clues on size, that inherently is more second half weighted, seeing very good early demand, and confident in the growth in the second half there.

You asked on the flow-through of kind of macro factors into our P&L. The typical timing from, let’s say, from kind of order, which physicians typically would order Cologuard or Oncotype during a face-to-face visit. Cologuard is a wellness visit. So I think of 30 to 40 days or so still from a wellness visit to the median time we get to revenue, there can be a longer tail. It can be up to, say, 12 months, and most of that happens fairly early. When you think – you asked on kind of overall hospital utilization, that’s not something we typically monitor broadly. We look more at things like wellness visits and screening trends. Wellness visit has been softer. This is a multiyear trend we’ve seen, they have been softer while there is still 60 million people out there who need to be screened today, and we expect very strong growth to continue.

Wellness visits have been down year-on-year recently, I think it’s even close to 10% in recent quarters. That’s something that we can fight through, given the opportunity that presents here.

David Westenberg: Thank you.

Operator: We might be able to take one more question, Mark Massaro with BTIG. Please go ahead.

Mark Massaro: Hi guys. Thank you. And Jeff, you’ll be missed, and Aaron, welcome to Exact. So I’ll ask two questions. One is for you, Kevin. You talked about USPSTF perhaps now in 2027. I think many of us were thinking 2026, although we also recognize there’s been a little bit of a delay with their bulletin. Can you just expand on why you think it will go into ’27? And then maybe for you, Jeff or Kevin, Certainly, I think one of the surprises on the call was your increased expansion of salespeople. Kevin, you indicated that overall spending will still be down in ’24 relative to ’23. Is that just on the sales and marketing line? Or is that total OpEx? And in order to keep your revenue guidance intact, help us think about what some of the puts and takes might be? In other words, should we expect a little bit of less investment in R&D?

Kevin Conroy: So what I said was that sales and marketing expense in ’24 would still be less than it was in ’22. So it will obviously be up from ’23 and somewhere in that range. And obviously, we have – we have a lot of room in our overall budget to be able to achieve all of our goals, both top line and bottom line with the resources we have. And again, I’d like to emphasize that this is a modest increase in terms of our overall sales spend, and marketing spend. But we would just for clarity sake, we wanted to deliver that. And also, I will reiterate our confidence in the guide. So we know our business, we know it really well. I’ll repeat what I said earlier with I’ve never been more confident about the near and long-term trajectory of Exact.

And we’re excited about Cologuard and also the new product launches that we have that are coming as well. In terms of the USPSTF timing, typically, what you would have seen already is in the first quarter document that emanates from USPSTF laying out what the study plan is and what the whole schedule is. And we just heard that, that may be pushed out a year. If it’s not a surprise, USPSTF is a really busy group with a fixed amount of resources. And if you remember, Cologuard when it first got included in the guidelines in 2014, the prior update was eight years before that. So although the stated schedule is five years, it was eight years and then five years that is being included yes. Yes. So it’s not unusual for there to be a little bit of a delay, and it’s critical.

There’s yes, aspiring entrants can come to market, but we know how hard it was to deliver on Cologuard in those early years, when we weren’t in the quality measures. It was – it was tough to get customers to order Cologuard as a replacement for the FIT test, which was in the quality measures. So, we’re in a strong position. And here’s another thing that people don’t fully appreciate. We’re already working on Cologuard 3.0. And so in terms of improved performance even from Cologuard Plus, we’re never going to stop investing in being the unquestioned leader in colon cancer screening. We’ve work really hard, to deliver on the impact that we’ve had in this disease. We’re proud of it. And our R&D team is second to none. And our commercial organization, we’ve been talking about the new heads – the impact Everett’s organization has had, it has been remarkable, and the leverage that they’ve been able to deliver.

They’re really proud of what they’ve done, and you’re just going to see continued positive results.

Mark Massaro: Great. Thank you.

Operator: We have a couple more questions here. I’m going to go to Eve Burstein with Bernstein Research. Please go ahead. Eve, go ahead with your question.

Eve Burstein: Hi there. Thank you so much. I appreciate the time. I’ll actually ask a question not about Cologuard, but about Oncotype DX Breast and how the FDA LDT rule affects it? This one is an interesting case, because you’re the clear market leader here, but some of your competitors in the space do have FDA approval. So a couple of parts here. One, our understanding is that your LDT test would be grandfathered in. You only need to pursue FDA approval if you decided to change the test, which seems pretty unlikely. Is that right? Two, if you did choose to pursue FDA approval, have you already generated the data that you need to do so in the rich body of literature you already have? Or would you need to do more work? And then three, if you didn’t choose to pursue FDA approval, could you be at a new competitive disadvantage versus the FDA-approved tests that are out there?

Kevin Conroy: You are correct. There is a grandfathering provision in the new guidance document. So Oncotype DX is in a great position in the U.S. and outside the U.S. based on our current regulatory position. That won’t change. And we’re also in New York State approved. So there are two different ways that we are okay with the current approach. We also have the ability to submit for FDA approval should anything change in the future, which we don’t expect to do. But we have more data with Oncotype DX than virtually any diagnostic ever developed. I think altogether, four or five New England Journal of Medicine publications, randomized studies and well over 1 million, probably well over 1.5 million total patient results. So it may be one of the most studied diagnostics, cancer diagnostics of all time.

We’re in great shape. And we’re in great shape from a competitive perspective. And that’s important, because Oncotype DX is the only test that has that Level 1 that Tier 1 evidence, because of the multiple randomized controlled studies. And other tests just have not been able to prove, what we’ve been able to prove both in terms of the ability to predict chemotherapy benefit, and also determine the likelihood of recurrence. Those are two benefits that nobody else has been able to show, with the level of evidence that we’ve been able to show. So, we’re confident in continued growth.

Operator: All right. Thank you, ladies and gentlemen. That concludes today’s call. I appreciate you all for joining. You may now disconnect.

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