Minimed Group (NASDAQ:MMED) held its fourth-quarter earnings conference call on Wednesday. Below is the complete transcript from the call.
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Summary
Minimed Group reported record fiscal 2026 revenue, surpassing $3 billion for the first time with high single-digit growth.
The company launched multiple new products, including MiniMed Flex and MiniMed Go, which are expected to drive growth in fiscal 2027.
Q4 revenue growth was 8.7% with strong international performance, though U.S. growth was impacted by timing related to the early FDA clearance of MiniMed Flex.
Minimed outlined a robust pipeline with new products expected to launch next year, including the MiniMed Fit patch pump and Vivera algorithm.
Management expressed confidence in achieving approximately 10% organic revenue growth for fiscal 2027, driven by new product launches and a strong international market.
Full Transcript
OPERATOR
Good day and thank you for standing by. Welcome to the MiniMed 4th Quarter and Fiscal Year 2026 Financial Results Conference call. At this time, all participants are in a listen only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you'll need to press star 11 on your telephone. You will then hear an automated message advice that your hand is raised to ask your question. Please press star 11 again.
Please be advised today's conference is being recorded. I would now like to hand the conference over to your speaker today, Ryan Weisspenning, Head of Mini Med Investor Relations. Please go ahead.
Ryan Weisspenning (Vice President and Head of MiniMed Investor Relations)
Hello everyone and thanks for joining us today for our fiscal 26th fourth quarter earnings webcast. Hi, I'm Ryan Weisspenning, Vice President and Head of MiniMed Investor Relations. Joining me today are Q. Dilara, Chief Executive Officer and Chad Spooner, Chief Financial Officer. Today's program will last no longer than 45 minutes so that we may complete the call before the market opens. Earlier this morning we issued a press release discussing our results and containing several financial schedules.
We also posted an earnings presentation to our website that provides additional details on our performance. Both can be accessed on our [email protected] during today's program, many of the statements we make may be considered forward looking statements which are subject to risks and uncertainties and actual results may differ materially from those projected in any forward looking statement. Please take a moment to review the cautionary statements regarding forward looking statements including in our earnings press release and the presentation.
Additional information concerning factors that could cause our actual results to differ is contained in the filings we make with the SEC and we do not undertake to update any forward looking statement or any of the information contained in this presentation. In this presentation we reference Organic Revenue Growth, a non GAAP financial measure. A reconciliation to the most directly comparable GAAP financial measure is included in today's earnings press release with our Organic Revenue Growth and adjusted EBITDA margin guidance.
We do not provide reconciliations to comparable GAAP measures because certain items in these forward looking non GAAP measures cannot be predicted without unreasonable effort. We operated as part of Medtronic until our IPO in early March. Our GAAP financial statements were therefore prepared on a carve out basis and include certain historical cost allocations from Medtronic for centralized support functions. We refer to certain financial information for MiniMed on a standalone basis.
This replaces those Medtronic historical cost allocations with the expected run rate cost structure for standalone MiniMedia. This information also eliminates the impact of certain incremental nonrecurring costs. These non GAAP standalone financial measures are included to provide consistency and comparability while evaluating operational performance on a run rate standalone basis for reporting periods after Minimed's fiscal year 2026. A reconciliation of these standalone non GAAP financial measures to their most directly comparable GAAP financial measures is included in today's earnings presentation.
With that, over to you.
Q. Dilara (Chief Executive Officer)
Thank you, Ryan and good morning everyone. It's good to be speaking with you today on our first earnings call as a standalone, publicly traded Mini Med. Before we go into the details, let me start with who we are and why we exist. Minimed exists to give people living with insulin dependent diabetes more time in range, more freedom from the daily grind of managing their condition, and more time to
simply live their lives. We do that today for 659,000 pump users around the world through the most complete, most clinically validated automated insulin delivery platform available anywhere. That has been our North Star for more than 40 years.
We went public in early March, the week after we received CE mark for the Instinct sensor made by Abbott with the MiniMed 7080G a year ahead of schedule. And the week after that we received FDA clearance for MiniMed Flex. Two quarters ahead of expectations for fiscal 26. We had record revenue, crossing the $3 billion threshold for the first time with another year of high single digit growth. These milestones reflect the acute focus we've had on driving pipeline execution over the last few years.
In Q4 we finished fiscal 26 strong and we're carrying that momentum into fiscal 27. Our Q4 revenue growth was driven by continued strength in international markets and sequential pump adoption momentum in the U.S. new sensors were a meaningful driver throughout the entire second half. Let me address U.S. performance directly. Growth of 1.5% in Q4 was below our initial expectations and I want to be clear about what drove it. FDA clearance of MiniMed Flex came six months early.
This is clearly positive news for us and a significant milestone, but it did create a short term dynamic where some customers who were close to a pump decision chose to wait for the new system. That's a timing issue, not a demand issue. Minimed Flex is the most substantial hardware and software pump update in a decade, and we're excited for with what we're hearing in the market about Flex's launch later this month. In addition to Flex, we pulled forward two more launches.
The MiniMed 780G with Instinct starts rolling out internationally later this month, giving our international pump users more sense of Choice and Minimed go our smart MDI system for the 15 million people worldwide on multiple daily injections launched in Europe earlier this year and in the US just this week. And it is these three products that underpin our confidence in our fiscal 27 growth. Behind these three, the pipeline is just as exciting. MiniMed fits our next generation Patch pump and Vivera, our fully closed loop algorithm for Type one and Type two, both on track for clearance next year.
Now looking at Q4 in more detail, starting with International As I mentioned earlier, our international business delivered a Strong quarter, growing 12% organic in acceleration from Q3. Increased templara availability drove a high single digit sequential increase in new pumps sold OR NPS and 100 basis point sequential increase in CGM attachment on a year over year basis. NPS were down mid single digits primarily due to a tough comparison in Q4 of last year.
That period benefited from the initial launch of Simplera which drove a meaningful acceleration in NPS and set a high baseline. We delivered strong international growth even before the Instinct sensor entered these markets. The EU Instinct launch opens up the MiniMed 780G to more than 4.5 million Abbott sensor users on insulin intensive therapy, a population we haven't been able to reach until now. Turning to the US with the context on overall US performance that I covered earlier, let me walk you through two components, CGM and pumps because the underlying dynamics in each tell an important story about where this business is heading.
US CGM revenue grew high single digits in Q4, our first full quarter with both Templara and Instinct available. Since launching Both sensors in Q2 USC GM attachment has increased by mid single digit percentage points. More of our pump users are using our sensors and that's the full stack working. When the sensor and pump are designed together powered by our Smart Guard algorithm, patients use them together and that creates a durable recurring revenue stream that compounds over time.
Our new sensor offerings are also bringing new patients to Minimed. US NPS were up year over year and up mid single digits sequentially, a leading indicator of where US revenue is heading. And here's why I'm confident about fiscal 27 census was a setup. Minimed GO and Flex are the follow through. Minimedgo launched two weeks ago. Providers can prescribe directly from their EMR to minimed pharmacy and the product is
shipped directly to patients. Pre orders for minimvest Flex started this week and we will begin shipping in a couple of weeks.
I have been out in the field extensively at key accounts, meeting with clinical teams, the reps the patients and the excitement is real. Flex is sleek and discreet and half the size of 780 with a 300 unit reservoir and app based control. Now combined with two great sensor options, this is the product people have been waiting for. To that end, let me turn to the pipeline because this is where I believe the long term investment thesis for minimed becomes visible.
We are in the middle of a complete portfolio transformation. Within 18 months a person living with diabetes will be able to choose minimed at every stage of their journey. Smart pen, patch or durable pump, all using the SMART for the same closed loop algorithm, the same app, all within the same ecosystem. One company, every option. I want to be clear about what this moment represents. This is the third generation of MiniMed. The first was defined by our pioneering insulin pump therapy, the second by our 780G and SmartGuard, the most clinically validated AIG system in the world.
The third era, the one we're building right now, gives patients the products they have been asking for. A durable pump that is half the size of 780 with a 300 unit reservoir, a patch pump with a 300 unit reservoir and up to seven days of wear. A smart MDI system for the millions of people not ready for pump therapy and a fully closed loop algorithm that ties it all together. We believe this will completely reshape how the market thinks about minimed.
Let me go deeper on the products that will define our next chapter. First with MiniMed Flex, our ECP or early commercial pilot is underway. We started taking pre orders this week and expect to launch Flex with integration to simplera Sync sensor later this month. Flex followed by Flex integrated with instinct in our second quarter similar to 780G. We are working on making Flex available through pharmacy and we will update you as the year progresses in international markets.
We submitted Flex for clearance this last quarter and we are expecting CE mark approval by the end of the calendar year with MiniMedGo, our smart MDI solution launched in Europe in late February and began its US launch last week with MiniMed Fit, our differentiated patch pump we expect to submit to FDA by this fall with commercial launch next calendar year. We've also made great progress on manufacturing and expect to have an initial capacity to serve 20,000 patients at launch and we are scaling production capacity quickly and Vivera, our fully closed loop algorithm for Type one and Type two showed impressive feasibility data at ATTD in March.
On average, users met ADA guidelines for time and range with no user input whatsoever, meaning no need to bolus or make mil announcements. We started enrollment in our US Pivotal for Vivera in February. We have already completed around 50% of the targeted enrollment and remain on track for launch next calendar year. With that, I'll turn it to Chad to walk through the Q4 financials and fiscal 27 guidance.
Chad Spooner (Chief Financial Officer)
Thanks Q4 revenue was $837 million up 8.7% organic driven by 12.2% growth in international markets. US growth was 1.5% driven by the short term dynamics that Q covered earlier. Our global growth was driven by our recurring revenue streams CGM and Consumables, which make up 80% of our business. CGM grew mid teens and Consumables grew mid single digits. For fiscal 26 we had record revenue, crossing the 3 billion threshold for the first time with an overall 8% organic growth.
Growth was led by International where we grew 11.2% by product line. Our recurring revenue streams from CGM and Consumables drove our fiscal year growth. The same dynamic that we saw in Q4 CGM grew low double digits in fiscal 26 as we launched new sensors around the globe. Q4 adjusted standalone EBITDA was 154 million, growing 32% two times reported revenue growth as a percent of revenue adjusted standalone EBITDA was 18.4%, an increase of 220 basis points versus Q4 fiscal 25 with 380 basis points of improvement coming from SGA and R and D.
Walking through the Q4P and L. Our adjusted standalone gross margin with 58.6%, an increase of 40 basis points versus the fourth quarter last year. This was driven by continued manufacturing efficiencies and an FX benefit offset by higher Simplera Mix which currently has lower margin than that of our Legacy and Instinct sensors. Q4 adjusted standalone SGA was 33.9% of revenue, an improvement of 140 basis points versus Q4 fiscal 25. As part of our MiniMed operating system, we have a robust productivity project funnel across the business we executed on these transformation projects to drive efficiencies.
Q4 adjusted standalone R&D was 11.6% of revenue. R&D spend was down 4 million from last year driven by lower clinical and operations R and D spend and as our new products launch for full year. Fiscal 26 adjusted standalone EBITDA with 482 million growing 27% or 2 times the rate of reported revenue growth as a percent of revenue. Adjusted standalone EBITDA was 15.6%, an increase of 160 basis points year over year with 350 basis points of improvement and coming from SGA and R&D.
Fiscal 26 adjusted standalone gross margin was 59.2%, a 50 basis point increase versus fiscal 25 driven by better conversion material productivity and FX offset by the mix impact from higher Simplera volume. Fiscal 26 adjusted standalone SGA was 35.2% of revenue, an improvement of 200 basis points versus last year. Similar to what I just discussed in Q4, the transformation projects delivered efficiencies and significant operating leverage throughout the fiscal 26 and fiscal 26.
Adjusted standalone R&D was 13.6% of revenue, a decrease of 150 basis points versus the prior year driven by lower clinical and operations R and D spend as our new products launch. That said, R and D on a dollar basis increased by $11 million year over year. From a cash and debt perspective, we started the time of IPO with $350 million of cash in the balance sheet and no long term debt. We ended the quarter with $298 million in cash and no long term debt.
This cash balance was ahead of our expectations as we focus on delivering good cash management. Turning to our key business metrics, we intend to provide you with new pumps sold or NPS and global CGM attachment rates on a quarterly basis. These metrics track the unique growth opportunities at Minimed first through the sale of pumps and then the associated recurring CGM revenue. Q4 NPS was 42,000 down low single digits year over year. Given the two dynamics that Hugh discussed, the US Flex early clearance this quarter and the International Simplera launch last year on a sequential basis, Q4 NPS was up 740 basis points from Q3.
We had robust sequential NPS increases in
both US and international as our new CGM sensor launches drove increased sales of our MiniMed 780G pump systems. Q4 CGM attachment rate was 68%, up 100 basis points from Q3 and an increase of 500 basis points year over year. We expect our CGM attachment rate to continue to trend upwards as nearly every new minimed pump user is using our CGMs to get the benefit of our SmartGuard automation. Turning to the full fiscal year, we sold 145,000 new pumps in fiscal 26 stable versus the prior year, but grew every quarter sequentially, including 26% higher NPS in the second half of the fiscal year than the first half.
The fiscal 26 average CGM attachment rate was 66%, an increase of 700 basis points versus a prior year. Like NPS Our CGM attachment rate increased sequentially every quarter in fiscal 26. Regarding our global pump users, we intend to update you on this metric on an annual basis. We ended fiscal 26 with 659,000 global pump users, an increase of 4% year over year. This was driven by increasing NPS as we went through the year and reducing attrition.
Let me talk about our readiness as a standalone company, in particular how the TSA exits are progressing. We have approximately 160 tsas with Medtronic and we have dedicated teams working with Medtronic, and we are confident that we will exit these TSAs in the timelines that we've established, most of which will occur in calendar 2027. Next, let's cover our outlook for the full year of fiscal 2027. We expect organic revenue growth of approximately 10%, which includes 1 to 1.5% from the extra week.
This is consistent with management's expectations at the time of our ipo. There are three large product launches that give us confidence in this growth outlook minimed Flex in the US Minimed Go Expanding Globally and the continued global rollout of of the Instinct and simplara sensors for Q1. Including the extra week benefit, we expect organic growth to be well above Q4. Excluding the extra week, we expect Q1 growth to be roughly similar to Q4 in the U.S.
we expect faster growth in Q4 and over the course of the fiscal 27, U.S. growth will be accelerating. Given the pull forward of the Flex launch. For fiscal 2017, we expect adjusted EBITDA margin of approximately 16% with the improvement driven by OPEX leverage in line with management's expectations at the time of ipo, we plan to leverage our global sales and marketing infrastructure to continue driving strong growth and margin expansion. We also expect to benefit from our strong product pipeline, including common platform components and software to deliver R and D leverage, and we also expect continued efficiencies from our support functions as
we look at our quarterly EBITDA cadence. Typically the margin starts below the annual amount and grows as we grow throughout the year. You saw this in fiscal 26 and we'd expect a similar cadence in fiscal 27. For Q1 fiscal 27, we'd expect adjusted EBITDA margin to be a couple hundred basis points greater than the adjusted standalone ebitda margin in Q1 of fiscal 26 and to grow throughout the year to reach our 16% annual outlook. While we don't provide specific guidance on our KPIs, we do expect that as we roll out our new pump systems and sensors.
We will continue to see growth in both NPS and CGM attachment rates. For more details on our guidance, see the guidance slide in our earnings presentations. Q back to you.
Q. Dilara (Chief Executive Officer)
Thanks Chad. We're excited by the growth opportunities on the top and bottom line that Chad just laid out. We are already entering the year with meaningful momentum. As a reminder, we share with you several pieces of new news today. MiniMedGo launched in the US last week. Instinct will launch in Europe later this month. We started taking Pre orders for MiniMed Flex in the US this week and will be shipping later this month.
And this morning we announced an extension of our partnership with Abbott to commercialize a dual glucose ketone sensor designed to integrate with our MiniMed smart dosing systems. And our pipeline with FIT and Vivera reflects a roadmap that spans near term execution and long term aid leadership. The aid market remains dramatically underpenetrated.
The type 2 opportunity is still in its early innings and the millions of patients still on MDI represent a Runway that will define this category for years to come. We are building to serve all of them and as we do, we expect this will create value for patients, their caregivers and physicians. And this will translate to value for our shareholders. I do want to say something about our team.
This past year we separated from a parent company, executed an IPO and kept launching products and delivering for patients all at the same time. Everyone executed multiple complex initiatives and I'd like to thank our team for their commitment and dedication. We know where we're headed. We'll keep you updated as we get there. Right, let's go to Q and A Operator.
OPERATOR
Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star 11 on your telephone. If your question has been answered or you wish to move yourself from the queue, please press Star one one again. We'll pause for a moment while we compile our Q&A roster. Our first question comes from Travis Steed with Bank of America securities. Your line is open.
Travis Steed (Equity Analyst)
Hey, congrats on your first earnings call as a public company. I maybe first wanted to ask about, you know, pump shipment came in above street. The new start metrics were really strong, but the pump revenues were light versus what we'd modeled. And I know you talked about maybe some delays ahead of Flex, but trying to understand how that impacts the model and just trying to understand some of the dynamics there on the pump shipmentments versus the pump revenue and delays around flex.
Q. Dilara (Chief Executive Officer)
Thanks Travis. You said it right. It's really about the timing issue of Flex customers make rational decisions and some chose to wait for the new system. We obviously have a lot of patients that like buttons and they don't want to have a phone controlling their pump. And so we saw that it was really great to see both the year over year in the US and sequential growth. And so if you look at the second half versus the first half, it's quite dramatic in terms of that leading indicator.
I think in terms of revenue, it was very consistent with what we expected. I think where us was under our initial expectations is actually driven by, I would say a weaker first half from pumps. And that obviously translates to consumable and CGM revenue in the second half. So think of it that way. But it really is a timing issue. We just started taking pre orders yesterday for Flex and it's extremely robust demand that we see already. Okay, thank you.
Next question. Thanks, Travis. Next question, please.
David Roman (Equity Analyst)
Kevin, one moment. Our next question comes from David Roman from Goldman Sachs. Thank you. Good morning, everybody.
I wanted just to start with maybe connecting some of the dots here across your exit rate performance, your guidance and the commentary cue that you made around the product momentum expected in FY27. So they look at the guidance of about 8.5 to 9%, excluding the extra week, and then the 8% you did in 26, but also the higher exit rate as you look at the operational drivers in 27.
There do look to be a number of factors that get better in this fiscal year around product launch momentum, instinct, integration, et cetera. So maybe you could just help us think through your guidance basis for FY27, how you're thinking about puts and takes. Maybe is there a degree of conservatism in here and how we kind of connect the pieces between the underlying fundamental drivers and how you're setting the outlook here.
Chad Spooner (Chief Financial Officer)
Hey, David, this is Chad. I'll start. And then you might add a little bit of color. But the first thing that I would like to say is that what we have set forward, we think is a plan that we're confident we can achieve. Right. When you look at the way we thought about the business before all these, we'll call it pull ins of product lines, these things were in our forecast just later in the year.
And so we're getting to them sooner. And what we're looking forward to is
actually showing execution and the results and then reevaluating at that point in time. But we think that the plan right now is a very solid plan that we're confident that we can hit is the way that we Think about it. So the product launches, and if you think even about Flex, we always had that in there. And so as Q talked about it being a timing, there's always a gap between announcing and that patient customer waiting period.
It has just shifted forward a little bit. So we think fundamentally the model is still intact from that perspective and the numbers are good. We feel actually super excited about the opportunities given how much we've brought these product launches in for the year and achieving our numbers.
Q. Dilara (Chief Executive Officer)
And David, I think, look, you've covered the space. I think you're going to see that not just for us, but the industry, when something new comes in, it typically takes a couple quarters. Patients just can't just get an appointment the next day with their Endo. They're going to have to go in and see them. We've got to drive awareness. So we're very encouraged with what we're seeing. We've done.
We've touched over 8,000 providers as part of the Flex launch. We've done more than almost 300 events.
So we're seeing a lot of demand. But, you know, people have to get appointments, they've got to go see their endo.
And so typically we see this play out in two quarters. Remember that in Q1 we're going to have Flex with Simplera for, call it, you know, five to six weeks.
Q2 will be the first quarter where we'll have both sensors integrated. And so that's kind of the buildup. And what we're trying to Signal is the U.S. we, you know, very confident that this progression, you'll see it go through the year and obviously as things emerge, you know, we'll update you. But that's kind of how we see the year unfold.
OPERATOR
Okay, thanks, David. We'll go to the next question, please.
Kevin, one moment. Our next question comes from Joanne Winch. with Citi, your line is open.
Joanne Winch (Equity Analyst)
Good morning and congratulations also on your first quarter out. So I want to just sort of pause on the sensor dynamic and I'm curious how we should think about the difference between Simplera, Instinct and now the dual Analyte sensor joining the mix and how you think about positioning the three of them and do you have a preference financially? Thank you.
Q. Dilara (Chief Executive Officer)
So let me start. Maybe Chad can answer the financial question. I think what we're trying to do, Joanne, is really offer choice between Simplera and Instinct. So let's talk about that, because those are in market today. I think we're excited about the dual Ketone glucose sensor, but that's not yet commercially available. It's been approved on cemag, but we're still waiting for FDA approval. And the reason for the choice is with Simplera being a seven day state, it really lines up with our seven day infusion set.
And so there are a lot of people who like to have a weekly routine. And so we offer that there's some other, I would say relatively minor differences between the two sensors and of course
with instinct being a 15 day sensor that helps people who like longer wear and the simplicity of that and we're seeing that in the numbers.
People like Simplera, they like Instinct, they're both easy to insert, but it fits into people's lifestyle in a different way and it's very consistent with our objective, which is to offer a portfolio that really meets the patient where they are wherever they are on the journey, whether that's with a smart MTI system with Minimed Go or a durable pump system with Flex and then in the future a patch option.
Chad Spooner (Chief Financial Officer)
And from a financial preference standpoint, Joanne, from the sensors that are available today because as Q said on the Ketone sensor, that's a ways out before we'll have more details in the financials there between Instinct and Simplera and Legacy. Legacy Sensor and Instinct, you know, we've said are comparable from a revenue and a margin standpoint and Simplera has a lower gross margin.
But it doesn't mean that we have a preference towards one versus the other because as we continue to scale up Simplera and in 2027 we're going to have significantly more than we had in prior years, which for us is great because it gives, you know, unconstrained demand internationally where Simplara has been selling quite
a bit and we need it for our products. That's the way we look at it. So we've priced in, we've modeled in the increase of simplera for fiscal 27 and for the expanded usages of all of Instinct. But we don't say we have a financial preference. We let the patients choose and we've got model them we think are appropriate margins for the different products.
OPERATOR
Thank you, Joanne. Next question please.
Kevin, one moment. Our next question comes from Steve Lichtman with William Blair. Your line is open.
Steve Lichtman (Equity Analyst)
Thank you. Good morning everyone. Just wondering again on the FY27 outlook, as you look at the 10% organic growth, any additional color you can provide on say us versus ous and around that 10% segment growth, which should be higher in your mind versus maybe a little lower.
Chad Spooner (Chief Financial Officer)
Hi Steve, thanks for the question.
As we don't give specific guidance on regions or by products to give a little color. The way that I would really think about it is OUS will continue to have strong growth throughout the year. You can look at historical execution and we don't see changes to that in the US As I referenced before, you're going to see a continued acceleration, right?
So the metrics that we look at as we look at those NPS and the growth that we've seen in the second half of the NPS is a leading indicator of what we're going to see for the growth going throughout the year. So the US We've seen that acceleration in the second half for the NPS on which it grew in the second
half versus the first. And so it'll be progression. Q1 obviously will be much more than you saw in Q4, but recognize that Flex has four to six weeks of selling in Q1, so that as we get into Q2, we've got a full quarter of Flex with Simplera and then we start to introduce Instinct, so you get even more benefit from that. And then Q3, you've got a full quarter of both of those sensors with Flex. So that's why we see that progressive growth in the US throughout the year
is the way I think about it. Okay, thanks, Steve.
OPERATOR
Next question please.
Kevin, one moment. Our next question comes from Peto Chickering with Deutsche Bank. Your line is open.
Peto Chickering (Equity Analyst)
Hey guys, thanks for taking the question. Yeah, just wanted sort of follow up, you know, just from a modeling perspective, you know, to help quantify the comments around the fourth quarter. Softness in the US Pumps due to fit launching for the timing of the launch and US Pump revenue cadence. Any quantification of how we should be modeling the US pump cadence launch throughout 27 as you think about the launch coming up soon?
Chad Spooner (Chief Financial Officer)
Well, the way that we don't really talk specifically on a product by product line level, but what you can think about is there's a couple hundred basis points right in the US from this flex.
The timing shift.
Some of it is people said, hey, we're going to wait for the unit. Some said, hey, we'll go on 7AG and we'll use your Flex Forward program. So it's hard to quantify the exact amount of that. But what we can see and what you can measure is, as I said before, the NPS growth and the cadence momentum there.
And so that's kind of what we're looking at from a How do we see this slowdown in the US for the fourth quarter and then accelerating and as Q said what we're seeing already, we've just started this week taking early orders. So we're excited about where we see
that growth coming in the US the
way that we always like to talk about the business is a full portfolio though because we have the US and as we balance the US growing to flex, we have consistent performance in OUS as well and we're expecting some strong performance there as well as we get Instinct and even before we expected.
So we're going to continue to see the OUS as well. So I like to think of our business as a whole complete the US and OUS. OUS driving 2/3 of the top line and we've got new products coming in both and I think just in terms
of the ramp and maybe color on kind of the commercial activities, our early commercial pilots underway. We have several hundred patients already wearing the device. You can check out the social media, it's extremely easy for them to use. We are looking forward to launching big time at ada and as I mentioned earlier today, we will be shipping Flex with Simplera later this month. It just takes time and then we're at Instinct.
Then you've got Medicare and then of course we are also we submitted Flex for CE Mark and we expect at the end of the year. So it's all part of the, as the year goes by this is going to be strengthening and we already see it in the, as we said, the key indicator which is the new pump sold leading indicator.
Peto Chickering (Equity Analyst)
Great, thanks so much. Thank you, Peter.
OPERATOR
Next question please. Kevin.
One moment. Our next question comes from Daniel Markowitz with Evercore isi. Your line is open.
Daniel Markowitz (Equity Analyst)
Hey guys, congrats on the first quarter out the gate and it's great to hear all the timing updates. It all sounds, sounds great. So ahead of the OUS Instinct launch, I wanted to ask if there are any early learnings to share from Instinct us in terms of maybe how big a percent of new CGM starts. Instinct is demanding and if you're seeing any trends in the Simplera installed base, if patients have any appetite to switch or anything else to call out.
Thanks for taking the question.
Q. Dilara (Chief Executive Officer)
Yeah, thanks for the question. I think what we're seeing is obviously most of the switching happening from our legacy sensor guardian 3 and guardian 4 to simplera anti Instinct. And I think as we mentioned in the prior quarters, the new sensors not only have driven up CGM attachment because of the power of our algorithm, but increasingly bringing new patients to Minimed. You know we have a lot of new starts coming from mdi.
We also seeing competitive switches and of course patients coming out of warranty. And that's why you see the second half pump shipments growth be so substantially higher than the first half. And so that's the pattern we continue to see. As I said, last quarter was the first full quarter of having both sensors in the market. We also increase simplera capacity, we tripled it in Q4.
And so we're starting to see really unconstrained demand coming through in international as well. And that's also driving additional pump growth because as you know, we have a very large install base. And so when you have something new like sensors, you can't just give it.
We would grow faster. We just gave it to all new patients. But of course we have to take
care of our install base. And so we effectively were on a bit of an allocation strategy which I think mooted a bit of the new pump sold metric in Europe, just really managing the installer base, trying to keep everybody happy. But now that instinct's coming in really a couple weeks in Europe unconstrained simplera, we're expecting that again the critical metric of new pump sold to continue to grow.
Daniel Markowitz (Equity Analyst)
Thanks, Daniel.
OPERATOR
I think we've got time for two more questions here before the bottom of the hour, so we'll take the next question, please.
Kevin, one moment. Our next question comes from Larry Beagleson with Wells Fargo. Your line is open.
Larry Beagleson (Equity Analyst)
Good morning. Thanks for taking the question. Q Congrats on the IPO here. Q Just what needs to be done on Mini Med Fit before the fall 2026 FDA submission. And on CGM, it's 50% of revenue carrying the growth attachment rate looks like it was up, I think about 500 basis points year over year in Q4. Is that kind of the way we should think about next year and where can that go over time? Thank you.
Q. Dilara (Chief Executive Officer)
So to answer your FIT question, we are tracking extremely well and our goal is not just to submit and get an approval. Our goal is to have a successful launch next year with our patch aid system. So obviously we're working on the submission
itself that is on track. We're also working on manufacturing. I think that we mentioned at least 20,000 patients at launch and we are already expanding capacity to take on more patients next year. So we feel very good about it. We're one of the few companies telling you what our initial production capacity is going to be. So it is all about gearing to launch and getting fit through the pharmacy channel with respect to the attachment rate. I think the way we think about it is over the last Few years we've demonstrated that the second generation algorithm 780 with Smartguard and now Flex with Smartguard is extremely powerful with the five minute
order correction, the mill detection technology really driving outcomes with less effort. And so really what we see is
every order for our aid systems come with our CGM consumable and we see that pattern continuing, which is why you see this very steady growth of CGM attachment. It's an important metric with respect to how it drives revenue. So we're not concerned about that at all. What really we are focused on now is growing that new pump sold metric with these new launches. And so as we get that metric up, the CGIM attachment will continue. So you want to add anything?
Yeah, no, I would just say, Larry, your math is good and the continuous rate of improvement is a good assumption that we've seen historically. And how high can we go? You know, as we continue to sell the new aid systems, everyone is going to be on our CGMs. So you can see that in the future, getting into the 90 percentile range, right? Globally with steady progression in the US and internationally.
Larry Beagleson (Equity Analyst)
Thank you.
OPERATOR
Thanks, Larry. We've got time for one more question. Kevin, let's go to our last question, please.
Maritha (Equity Analyst)
One moment. Our next question comes from Maritha with btig. Your line is open.
Hey, great. Thanks for squeezing me in and congrats on everything you've done to get to this point. Wanted to ask about Minimed Go here. How are you thinking about the initial uptake trajectory given this is effectively a new patient segment for Minimed with these MDI users and likely requires a different commercial strategy. So any details on the trajectory as well as what you're doing to establish formulary access and reimbursement coverage.
Q. Dilara (Chief Executive Officer)
Thanks. So, with respect to the US Mini
Medgo we launched actually just last week, it's gone incredibly well. But as you said, Marie, this is a new category. We have started a dedicated primary care sales team. We think this will help reach patients early in the funnel, but it does require market development. From a reimbursement standpoint, we actually are pretty well positioned. We have great reimbursement for our CGMs in Penn, as you know, has been in market for a while.
This really, this Mini Med Go system now brings all of that together. So from an access standpoint, we feel pretty good about where we stand commercially on it, but it does require market education. And that's why we have this dedicated primary care team out in force now, really driving up demand. And we're already seeing orders come through a lot of excitement on this therapy option.
Maritha (Equity Analyst)
Okay. Thank you, Marie.
Ryan Weisspenning (Vice President and Head of MiniMed Investor Relations)
And for those analysts that we didn't get to this morning, we're happy to connect with you later today. I want to thank everyone who joined us today. We appreciate your interest and support in Minimed. We, we look forward to connecting with you on our Q1 earnings call, if not sooner, as part of our outreach here during the quarter. So with that, have a great rest of your day.
OPERATOR
Thank you.
Ladies and gentlemen, that concludes today's presentation. You may now disconnect and have a wonderful day.
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