Medtronic plc (NYSE:MDT) Q2 2023 Earnings Call Transcript

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Larry Biegelsen: Thank you. Can you, guys hear me, okay?

Geoff Martha: Yes. Hi, Larry.

Larry Biegelsen: Good morning. Thank you for taking the question. Maybe on diabetes for Que. So Que, just a multipart question here. Did you ask for a variance on 780G? And if so, what was the response or when will you know? And if you don’t get a variance, do you need reinspection for 780G clearance? And how long do you expect that to take? And just lastly on 780G, do you expect it to have the same impact in the U.S. as you’ve seen outside the U.S.? Thanks for taking the question.

Que Dallara: Thanks, Larry. So on your first question, no, we did not ask for a variance. We’ve been focused on lifting the warning letter. I’m pleased to say that we are 100% complete on the warning letter commitments, and we have welcomed the FDA back in to assess our current status. So I think that’s forward progress, and that’s the clearest path because, obviously, it’s not just 780, but it is a whole pipeline of innovation that we care about from a growth perspective. So there is progress there. It’s very hard to say, timing on that. I think that’s up to the agency. We know they are working very hard on that. So we anticipate progress there as well. On your question around 780G progress in international markets, we’re very pleased with the double-digit performance there.

We do expect to see something similar in the U.S. market once approved. We are actually doing €“ we’ve been really happy with how 780G has performed in the U.S. market. It’s helping to stabilize attrition here. And as you know, our customers have a free upgrade option with 780 once approved in the U.S. market. And sorry, Larry, I missed your third €“ your second part of the question.

Larry Biegelsen: No, Que, that’s helpful. I guess, why didn’t you ask for variant in the U.S., it seems like a kind of no risk option here? So why not ask for it. Thank you.

Que Dallara: Primarily because as we’ve stated, we’ve been focused on really the long-term lifting up the warning letters is critically important. It’s not just about 780G, but it’s still about the pipeline. You know we submitted Simplera for CE Mark this year. We just submitted 780G with Simplera IDE last week. So, there is a long line of innovation that that we are interested in. And we were also very pleased with the progress we’re making on correcting the warning letter commitment. So with those things progressing at the pace, we did not feel it was necessary to seek a variance.

Larry Biegelsen: Alright. Thanks so much for taking the question.

Geoff Martha: Thank you, Larry. Next question please, Ryan.

Ryan Weispfenning: The next question comes from Matt O’Brien at Piper Sandler. Matt, please go ahead.

Matt O’Brien:

Geoff Martha: Okay. There seems to be a problem, Matt, with your audio. Maybe we will take the next question, Brad, and then we will try to come back to Matt.

Brad Welnick: Yes. The next question comes from Josh Jennings of Cowen & Company. Josh, please go ahead.

Geoff Martha: Josh, are you there?

Josh Jennings: Yes. Can you guys hear me okay?

Geoff Martha: Yes, we can hear you, Josh.

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