Joanne Wuensch: AGENT.
Michael Mahoney: Thanks, Joanne
Operator: Thank you. The next question comes from Larry Biegelsen with Wells Fargo. Please go ahead.
Larry Biegelsen: Good morning. Thanks for taking the questions. Congrats on a strong finish here and the approval of FARAPULSE in the US. On FARAPULSE, can you talk about the manufacturing capacity for the catheter and console upon launch? And expectations for the EP business this year? You know you grew 43% in Q4’23. Any reason why growth would be lower in ’24? And I have to ask you to please clarify your comments around ACURATE Neo2. It sounds like something happened with Prime, which is the larger size. What are the implications for the other sizes of Neo2 in Europe and the US? Thank you.
Michael Mahoney: Thanks, Larry. Starting with FARAPULSE, really very proud of the global supply chain team and what they’ve done over the past 18 months in the FARAPULSE Group that we originally acquired a while ago. But they’ve done a tremendous job in building capabilities to supply this for the US launch and to expand in Europe, and eventually Asia, as we just highlighted. So we are now significantly improved our catheter and console supply. We opened numerous centers in Europe in the fourth quarter and we’re ready to go. So we, at this point, don’t anticipate supply being an issue to continue to support Europe or to facilitate the US launch, given the capabilities and investments that we’ve made in approvals to manufacture in multiple locations.
So great work by the supply chain team. And we’re ready to launch this in the US. On ACURATE Neo2, as I mentioned in the earnings script, maybe just two overall points. We continue to do very well with ACURATE Neo2 in Europe, implanting, I think, the number 70,000, and continuing to grow faster than the market in Europe. And we are on track for what we have is called Prime in Europe in 2025. So that continues to move forward as planned. With respect to the trial, as I mentioned in the script, based on the interim analysis, we now need to wait for the full one year follow up of the 1,500 patients. And as a result of that, we don’t — we will not be receiving approval for ACURATE Neo2 in 2024. And we will wait until likely near the end of 2024 for the full readout of the ACURATE IDE study to determine our path forward.
Larry Biegelsen: Thank you, and congrats, Lauren.
Lauren Tengler: Thanks, Larry.
Operator: The next question comes from Vijay Kumar with Evercore ISI. Please go ahead.
Vijay Kumar: Hey, guys. Thanks for taking my question and congrats on a really strong finish here. Maybe just one on the guidance here perhaps for Dan. Dan, the 8% to 9%, it looks like FARAPULSE, the prior guided, I’d assume, a back half launch. It’s coming in a little bit ahead. Can you just, you know, walk us through the 8% to 9%. Is that right that FARAPULSE, perhaps, assumptions have changed? Any impact from VBP or base impact that we should be aware of? And what is — what are you assuming for pricing in fiscal ’24? Thank you.
Daniel Brennan: Sure. So the VBP assumptions are the same as they’ve always been, really no change there. As you saw, in December, when we issued the press release on AVANT GUARD, we moved up the timing of expected FARAPULSE launch to Q1. So we’ve been anticipating Q1 launch. And that 8% to 9% full year and the 7% to 9% for the first quarter in terms of revenue growth contemplated a Q1 approval of FARAPULSE, as Mike said, you know, there’s probably some contribution in Q1, but more of that contribution comes in Q2 to Q4. So the 8% to 9% has that contemplated in the overall guide. And then pricing, so I would say on pricing is, we were basically flat in 2023 and the goal is to be flat again in 2024. So likely no impact would be the goal in 2024 versus 2023.
Vijay Kumar: Fantastic. Sorry, on days, Dan? Any days impact here?
Daniel Brennan: No, all the days — there’s a lot of, obviously, a lot of noise in days around the world through the year. It’s all contemplated in the guidance. All in the 8% to 8% for the full year.
Vijay Kumar: Fantastic. Thank you guys.
Michael Mahoney: Sure, Vijay. Thanks.
Operator: The next question comes from Danielle Antalffy with UBS. Please go ahead.
Danielle Antalffy: Hey, good morning, everyone. Thanks so much for taking the question. Just a follow-up question on ACURATE Neo2, Mike, if I could. So appreciate the comments that you did provide. Just curious, I mean, obviously, you’re giving pretty strong guidance here for 2024. I mean, is the right read here that regardless of what happens with ACURATE Neo2 and timing there, you’re sticking to your long-term sales growth guidance that you provided back in September. And sort of how do we think about this as a long-term growth contributor now, given this little wrinkle here? And Lauren, we will miss you very much. Thanks so much.
Michael Mahoney: Lauren is not leaving the company. She will be around. She’ll be around. We’re still going to see her.
Danielle Antalffy: But we won’t get to see her, so.
Michael Mahoney: Okay, well.
Danielle Antalffy: I’ll work my way in.
