Operator: The next question comes from Chris Pasquale with Nephron Research. Please go ahead.
Chris Pasquale: Thanks. Appreciate it. How are you thinking about the opportunity for AGENT in the US? And you mentioned you’re still working to ramp up manufacturing capacity. When do you expect to be in a position to move into a full launch with that product?
Mike Mahoney: Sure. So, it’s a nice approval, excellent trial designed by the clinical team, and the product is doing extremely well in Japan, and we have high hopes for the product, as it impacts in the second half and more in 2025. So, currently, we’re really going through the contracting process with most of the big accounts in the US, and that’s initiated, and that’s going well given there is a high unmet clinical need with in-stent restenosis and the deliverability that’s been proven with AGENT. So, there’s high physician demand for it. But we are going through contracting process with the major health systems now, and you’ll start seeing some sales in the second quarter, and we expect that to ramp more significantly throughout the second half of the year and accelerate more in ’25.
Ken Stein: Yeah. Chris, and just to remind everyone, right, our current label indication in the US in-stent restenosis, that comprises approximately 10% of current PCI volume. Internationally, we also see DCBs used and we believe there is a potential use case outside of in-stent restenosis, small vessel disease, bifurcation lesions, potentially even some acute coronary syndrome. And once we launch in the US, we are evaluating opportunities to expand the label, and those expanded indications could potentially take us up to 20% of current PCI volume.
Chris Pasquale: Great. Thanks.
Operator: The next question comes from Matthew O’Brien with Piper Sandler. Please go ahead.
Matthew O’Brien: Good morning. Thanks for taking the question. I don’t have perfect numbers here, but in looking at the US EP number in Q1, it looks like you did somewhere around $40 million in FARAPULSE revenue between the generator and the catheter itself. Is that roughly the right number? And then, when I start to carry this out through the rest of the year plus the guidance increase, I’m getting something more like $300 million to even $400 million at FARAPULSE this year. Is that around the right number? And can you manufacture enough product to support that? Thank you.
Dan Brennan: Yeah, we won’t confirm your math. At this point, we’re not going to be breaking out FARAPULSE cases, numbers, number of accounts, dollars and so forth yet. If you recall back to the WATCHMAN days, we really waited till it was about a close to $1 billion platform before we provided that based on the materiality of the company. But it’s going extremely well. And importantly, we made significant investments in the supply chain two and three years ago to be ready for where we are today. And the supply chain team continues to perform extremely well and they’re able thus far to meet the demand in Europe and the US and the future in Asia.
Operator: The next question comes from Matt Taylor with Jefferies. Please go ahead.
Matt Taylor: Hi, thanks for taking the question. I actually wanted to follow-up on your AGENT commentary. Two small questions. One is, can you talk about the materiality in Japan? And when you mentioned the indication expansions, could you talk about what those could look like and when we could see them in the US?
Mike Mahoney: Just maybe really not a whole lot of new color in Japan, but they launched it last year and it was adopted very, very quickly and leading to the strong double-digit growth in Japan that we saw in the quarter. In terms of indication expansion, Dr. Stein, if you want to take that one?
Ken Stein: Yes, Matt. Again, I think probably the first new indications we think about looking forward would be small vessel bifurcation lesions, still working through regulatory strategy on that. So not prepared to give you a timeline for when we would initiate any of that work.
Matt Taylor: All right, great. Thank you for the color.
Operator: The next question comes from Matt Miksic with Barclays. Please go ahead.
Matt Miksic: Hey, thanks for taking the question. So just maybe one follow-up on the cadence for FARAPULSE this year in the US and sort of how the RHYTHMIA adoption navigation kind of plays into that. Any color for what we can expect as you get into the rest of the quarter would be great. Thanks so much.
Mike Mahoney: Thanks, Matt. Probably not too much new commentary here. I think, in FARAPULSE overall, it’s — we’re developing very strong capabilities to install, support and train doctors and really scale that up in the US, given the high demand for it and we’re able — resource wise, we put a lot of focus on that as we continue to expand that. And there obviously are a lot of strong relationships we have with those EPs given our WATCHMAN experience and our CRM experience. So, it’s a lot of resource planning and training and executing every day in the field to open up new accounts. Dr. Stein gave some commentary on the mapping. So today, some accounts don’t use mapping when they’re driving maybe optimal workflow, and many accounts are using their existing mapping system.
And we don’t intend to force our customers to move away. However, we do, as Dr. Stein mentioned, based on what we’ve seen with the — our mapping navigation system, we do think there will be incremental clinical benefits and productivity gains in using that. So, we are starting to see an increase in RHYTHMIA orders and we anticipate enhanced RHYTHMIA FARAPULSE mapping orders as we go through the second half of this year, because there will be clinical benefits from it. But as Dr. Stein mentioned, we really want to have hospitals choose the correct mapping system and FARAPULSE works excellent today with competitors, but we expect some enhanced benefit with ours.
Matt Miksic: That’s great. Thank you.
Operator: And just to verify, is there time for one last question?
Jon Monson: Yeah, Drew, we’ll take one more please.
Operator: That will come from Michael Polark with Wolfe Research. Please go ahead.
