And so we know there’s going to be competition. We know our competitors continue to try to innovate, but we’re very, very confident in our competitive position and our growth profile. And that’s why we’re so excited about the growth catalysts we have coming in 2024. As to patch pump companies there’s patch pumps — we’re the leader in patch pump. There’s not really a viable patch pump competitor that we see on the horizon. And so that’s another reason that we’re very, very bullish on our position and expect to continue to lead the market.
Operator: Our next question comes from Mike Kratky from Leerink Partners. Please go ahead. Your line is open.
Mike Kratky: Hi, everyone. Thanks for taking our question. So regarding the ongoing SECURE pivotal trial for Omnipod 5. How are you thinking about how that could impact the commercial opportunity for this product over the next few years? And what are the other main drivers that you expect to increase penetration within the insulin-intensive Type 2 patients that remain so underpenetrated?
Jim Hollingshead: Thanks for the question. We’re very excited about the SECURE trial. And as I said in our prepared comments, we’ve completed the goal for recruitment. And so just to be clear what that means that trial is designed to be up to 400 patients, but it has a minimum number of patients that are required. And so we crossed over the hurdle for the minimum number of patients. And the way to think about that is that it derisks the trial from an enrollment point of view. So we now are certain to have enough patients to successfully complete the trial. Enrollment is still open. So we’ll continue to enroll some patients for the next little while because it’s always better to have more patients in the trial rather than fewer.
But — so the trial is derisked operationally now with enough patients in to get a powered results that we need. And we’ll continue the trial. And then it’s a 13-week protocol. Once the last patient is in they’ll complete the 13-week protocol. We’ll gather the data, we’ll clean the data, we’ll prepare submission and so on. And then it will be in the hands of the FDA. And that will be a huge unlock for us in the Type 2 space. We’re already the market leader in Type 2 with Omnipod DASH. Omnipod DASH has had an indication for use in Type 2 for some time. And we’ve been promoting Omnipod DASH for Type 2 this year. And you can see the results already. So if you saw quarter-over-quarter DASH actually did really well in the quarter, a little bit better than last quarter in terms of percent of revenue.
And that’s clearly because as we’re out talking to physicians about Type 2 patients and Pod therapy we’re driving growth in Type 2. We also know — even though we cannot promote Omnipod 5 because it does not yet have an indication for use we do know that AID for people with Type 2 and specifically Omnipod 5 AID for people with Type 2 has very high appeal and physicians are writing it off label even though we’re not promoting it. And so when you take those two things together the success of Omnipod DASH in the Type 2 market, the obvious pent-up demand for Omnipod 5 in the type two market once we get the indication for use with a successful result from the SECURE trial we think it will unlock massive growth for us. That will come in the endocrinology channel.
That’s what we also think type 2 growth can come out of the PCP channel which is why we are piloting Omnipod GO in the PCP channel because it extends our reach upstream for type 2 patients, as they initiate insulin therapy with a basal offering. And then as they progress, they will already be on an Omnipod offering and they should pretty seamlessly progress onto either Omnipod DASH or Omnipod 5.
Operator: Our next question comes from Steven Lichtman from Oppenheimer. Please go ahead. Your line is open.
Steven Lichtman: Thank you. So you mentioned earlier you’re clearly moving your prescriber base past high-volume endos. Do you need to expand sort of your feet on the street meaningfully as this prescriber base continues to grow? Or are you seeing leverage opportunities from your current team?
Jim Hollingshead: Great question, Steve. And I would say two things on that front. The first one is, we are considering expanding feet on the street and that’s part of the Omnipod GO commercial pilot to figure out how many feet on the street we need to get the reach that we want. The other thing is we get a lot of leverage out of DTP. And so a lot of the physicians that are writing for us, don’t necessarily have a rep calling on them right now. And what’s happening is our DTP advertising often reaches physicians by the way. So they often see the product through our online media or maybe on the TV ad, but patients go in and ask for Omnipod into those practices that we don’t necessarily have a call routine with. So we’re getting leverage in that way already. And then we will consider adding feet on the street as you say as appropriate over the coming quarters.
Operator: Our next question comes from Chris Pasquale from Nephron. Please go ahead. Your line is open.
Chris Pasquale: Thanks. I just want to follow-up on the O5 type 2 opportunity. How are you thinking about the time line for FDA approval? And then also for presentation of that data – because it sounds like there’s also already a fair amount of off-label interest. And it would seem like perhaps the data presentation itself could be a catalyst to spur even more interest before you actually get the labeling?
Jim Hollingshead: Great questions, Chris. First on timing, we haven’t announced a formal time line on getting to an FDA clearance out of SECURE trial, but it’s fairly easy to do the math. I think the last patient will probably be in no later than the end of the calendar year a 13-week protocol analyze the data to do a filing. So I think it’s safe to say that, we’ll be filing with the FDA in 2024 for sure for clearance. And then we’ll see what happens in terms of — each of those steps can have a plus or minus on the time line on them. But we expect to file next year for that. In between now and then there’s a couple of things that are in terms of data on the study. We have published data out of our type 2 feasibility trial. And as we’ve referred to that in the context of the GLP-1 news that what we do see in — out of our feasibility data is that the patients in that smallest trial who were also on GLP-1s actually did better on Omnipod 5 than patients not on GLP-1s and for reasons that we explained in the slides that we posted last quarter and that we’ve updated this week.
And so GLP-1s make the body more sensitive to insulin and they reduced the required dose. And so the combination of the 2 actually ends up with a better outcome for patients which is interesting. And along those lines we anticipate that we will have a large number just about half plus or minus of the current enrollees in that trial are already on either an SGLT2 or a GLP-1. And so we anticipate being able to report out on subsets of the trial. That may happen — it may happen before the FDA filing it may happen after but we anticipate being able to do some kind of scientific reporting on that as well during 2024.
Operator: Our next question comes from Marie Thibault from BTIG. Please go ahead. Your line is open.
Marie Thibault: Thanks for squeezing me in. Congrats on the iOS clearance. Just a quick one here on that. When might we see the G7 Omnipod five integrated with iOS as well just all the latest generation? Thanks.
Jim Hollingshead: We haven’t guided the timing on that Marie. You can imagine that that’s a very urgent matter for us to get to. But we’ll do first things first. And so we’ll get an LMR with iOS which will be a G6 offering initially. And we’ll get into LMR G7 and then the two systems will come together after that.
