Senseonics Holdings, Inc. (AMEX:SENS) Q3 2023 Earnings Call Transcript

Operator: Thank you. And our next question comes from Mathew Blackman with Stifel. Please go ahead.

Unidentified Analyst: Hi, this is Colin on for Matt. I also wanted to start on the US performance. And the visibility you guys have into new patients starts given the recent dynamics with Ascensia destocking in the first half. So is the $3.9 million in revenues this quarter, the right quarterly run rate to think about the US launch from here? Any visibility you have there would be great.

Tim Goodnow: $4.1 million this quarter is in the US. [$3.94 million] (ph). So yeah, that — as we are building product in the third quarter, you really are filling the channel, of course, for the fourth quarter. In reality, by the time that it goes out for stocking that happens at the Ascensia’s distributors as well as with Ascensia as well. So, that’s certainly our plan going forward. We do have a couple of dynamics that as we think about, and we’re not ready to give guidance for 2024 for sure. But it is a pretty important year for us. On the one hand, we do have a lot of good work and excitement that we’re seeing in the marketing campaign, but we also do have the transition to the one-year product that we need to think about. So that’s going to have some inventory dynamic as well. So we’re working with Ascensia now to have that all scoped out. We’ll look to give a better perspective the next time we speak.

Rick Sullivan: Yeah, Colin, we maintain the two-thirds of our revenue coming from the US this year. We’re pretty close to that in Q3, and we expect that for the full year. Two-thirds US, one-third OUS, and are pretty happy with coming in at the midpoint of our guidance.

Unidentified Analyst: Okay, great, that’s helpful. And I wanted to squeeze one in on the pipeline. I was curious what your general sense is of how long it generally takes to start integration activities with pump partners after receiving iCGM. You gave an encouraging update about expecting it early in the year. How quickly can you integrate? And will Beta Bionics be first? Thank you.

Tim Goodnow: Yeah, I mean, I can’t speak to who’s first. Obviously, we’re very excited about the Beta Bionics technology, the clinical testing that we’ve shown to-date. It does take those organizations a little bit of time to put it out. I think you’re seeing that with the some of the folks that are transitioning to the Dexcom G7 product. So there is some certain work to do, but it does all start with that iCGM designation and we’re actively working on to get that wrapped up in the first quarter. So not ready to speak to timing yet, as it really does come from the other side, but it’s a high priority for us.

Unidentified Analyst: Thank you guys so much.

Operator: Thank you. And our next question comes from Jayson Bedford with Raymond James. Please go ahead.

Jayson Bedford: Good afternoon. Just a few and they may be all over the place. But remind me, when do you plan on submitting the 365-day data to the FDA?

Tim Goodnow: Mukul, you want to go ahead and talk through that?

Mukul Jain: Hey Jason, yeah, so we are thinking in the first half, there will be some dependency on when we hear back on the other submission that’s in active review right now. So — but that’s where we are kind of pulling it together, getting it ready and then waiting to hear back and send it in. So, I would say somewhere in the first half.

Jayson Bedford: So, first half submit, the expectation would be 2025 for approval? Is that fair?

Mukul Jain: No, no, our expectation is six months, is typical for our approval. That’s what we have seen based on past history.

Jayson Bedford: Okay, so it’s still late ’24?