that's a patch pump, they're also looking for the best outcomes. BIT will pair a highly differentiated patch platform with our smart guard algorithm at launch and a simple over-the-air upgradability to fully closed-loop capabilities when Vivera is available. As we said in June, we expect to have manufacturing capacity to support 20,000 patients at launch, and we have designed our production line to scale efficiently as demand grows. Now moving to our Vivera fully closed loop algorithm, I have more good news to share with you today. We have recently completed enrollment in our U.S. pivotal trial ahead of schedule. Having roughly half enrolled when we spoke to you in June, this achievement further reinforces our leadership in AID as Minimet is the only company with a fully enrolled U.S. pivotal trial for a fully closed loop algorithm. This represents a major milestone forward toward what we believe will be the most meaningful advancement in diabetes management since no finger sticks came to CGM. Vivera has the potential to expand the penetration of automated insulin delivery by dramatically reducing the burden in place on both patients and providers. We expect to have Vivera on the U.S. market in the second half of calendar year 27 for for both MiniMedFlex and MiniMedFit users. Viveira is our third generation algorithmic platform leveraging our meal detection technology to achieve the original vision behind automated insulin delivery. And that is the delivery of outstanding glycemic outcomes with very little burden on the user or prescriber. Unlike competitors' AID systems that still rely on meal announcements, all-carb counting, extensive physician programming, and patient interaction, the only thing Vivera requires to get started is a patient's total daily insulin dose and does not require meal announcements. And we expect Vivera to reduce these burdens while still delivering a time in range above ADA guidelines. In feasibility data that we presented at ATTD in March, Type 1 users, on average, exceeded ADA guidelines with no user input at all and were able to achieve 74% time in range. Vivera is designed to meet people where they are. You can let Vivera handle meals on its own or count cars when you want more control while it keeps learning in the background. That is the advantage of the architecture. One system can deliver simplicity for the least engaged user and precision for the most. without forcing either into a separate product. We believe Vivera's outcomes are possible because of advantages competitors simply cannot replicate quickly, including over a decade of proprietary insulin and CGM data, our digital twin technology that allows us to simulate millions of patient scenarios before entering clinical trials, and an algorithm architecture originally designed to mimic the function of a healthy pancreas. Vivera will launch through an over-the-air upgrade to our store base, creating a powerful combination of clinical differentiation, scalability, and commercial leverage. We do not view Vivera as the next version of an algorithm. We view it as a category-defining platform that brings fully closed-loop therapy to both type 1 and type 2 patients at scale, further expanding the gap between mini-med and the competition. A fully closed-loop algorithm with either tubed or tubeless device options will be attractive to people on MDI and especially type 2 users with the ultimate ease of use without compromising on glycemic control. Finally, we're often asked what comes after Flex, Go, Fit, and Rivera. Today, we can begin to answer that question. Our next-generation Minimed extended wear sensor recently received IDE approval from the US FDA and we expect to begin our pivotal trial in October. While we're not prepared to discuss the targeted wear duration or features at this stage, the sensor incorporates a new chemistry sensing platform relative to Simplera and represents the next step in our long-term sensor roadmap. In addition to improving the user experience, our next generation extended wear sensor will leverage the same manufacturing platform and production lines we use today, creating a direct path to both scale and margin expansion. As we continue to increase manufacturing output in improved yields, a longer wear sensor also allows us to spread sensor manufacturing costs over more days of use. We expect this to be creative to margins while strengthening our competitive position in a market where census longevity remains a key purchasing criterion. Most importantly, this program demonstrates the innovation at Minimed does not stop with the product scheduled to launch next year. We continue to invest aggressively in technologies that will define the next generation of diabetes management, including census, reinforcing our confidence in the durability of our product leadership, our long-term margin expansion opportunity, and our ability to sustain growth well beyond our current product cycle. Flex, Go, Fit, Vivera, and now our next generation sensor. At Minimed, we are building for the next quarter, the next year, and the next decade. With that alternative, Chad to walk through the Q1 financials and our guidance.
Thanks, Q. Q1 revenue was $843 million, up 15.8% organic, driven by an acceleration in our U.S. business, which grew 13.1% and a strong 16.9% growth in international markets. As Q noted, our Q1 growth benefited from an extra week, giving our 52-53 week fiscal calendar. We estimate the extra week added 1 to 1.5 percentage points of growth to the fiscal 2027, which translates into 4 to 6 points to Q1, consistent with our previous estimate. Importantly, even excluding the benefit of the extra week, we saw accelerating demand trends across the business. Organic growth excluding the extra week was in the low double digits compared with 8.7% growth in Q4. Growth was driven by both pumps and CGM, which grew in the low 20% and the high teens, respectively, reflecting the success of our recent product launches. Our continued sensor launches drove pump adoption globally, while the launch of Minimed Flex in the U.S. further accelerated new pumps sold growth. This growth in pumps expands our installed base and creates future recurring revenue opportunities through CGM and consumables. Consumables grew low double digits in the quarter and together with CGM represented 82% of our revenue, continuing to provide a durable and growing reoccurring revenue stream. Q1 adjusted EBITDA was $83 million, resulting in an adjusted EBITDA margin of 9.9%. This included an approximate 230 basis points impact from two specific items. The acceleration of planned investment and a non-operational FX remeasurement charge. First, we elected to pull forward approximately $8 million of investment in support of key growth initiatives, including the flex launch, as well as accelerating the FIT FDA submission to deliver this milestone ahead of plan. This reduced Q1 EBITDA margin by approximately 90 basis points, but does not change our full year spending plans or EBITDA expectations, as this was a timing shift of planned investment, not incremental spending. Second, we recorded a $12 million FX remeasurement charge on balance sheet items, which reduced EBITDA margin by approximately 140 basis points. This non-operational charge reflected changes in the value of foreign currency balances held on our balance sheet as exchange rates moved during the quarter. Excluding these two timing-related and non-operational items, adjusted EBITDA margin would have been 12.2% for the quarter, reflecting the underlying operational performance of the business. Our operational performance was affected by less favorable operating foreign exchange movements during the quarter, which had roughly similar impact to EBITDA margins as the balance sheet remeasurement. During the quarter, we implemented our foreign exchange hedging program, which we expect will reduce the earnings impact of future currency volatility, including balance sheet remeasurement effects. Importantly, our underlying business performance remains strong. Gross margin is trending ahead of the assumptions embedded in our original full-year outlook, and we continue to deliver meaningful operating leverage across the business. Together with the timing-related nature of the accelerated investment and the implementation of our foreign exchange hedging program, these factors support our confidence in delivering our full-year EBITDA margin guidance. Walking through Q1 P&L, our adjusted gross margin was 55.9 percent ahead of our expectations. As we discussed previously, Simplera currently carries a lower margin than our legacy and and Instinct sensors, and that mix impact is reflected in our gross margin this year. However, Simplera yields are trending better than expected, resulting in less impact than we previously modeled for the full year. Adjusted SG&A was 36.1% of revenue, an improvement of 30 basis points versus Q1 fiscal 26, or 70 basis points, excluding the pull forward of sales and marketing investments as we continue to drive efficiencies and leverage. Adjusted R&D was 13.6% of revenue. R&D spend was down $2 million versus a prior year as we continue to drive efficiencies in clinical, engineering, and operations R&D. R&D drove 260 basis points of improvement versus Q1 fiscal 26, or 300 basis points excluding the pull forward of FIT investments. Turning to our key business metrics, Q1 new pumps sold, or NPS, was 34,000, up 7.7% year-over-year. On a sequential basis, NPS was down given normal Q4 to Q1 dynamics. As Q mentioned, U.S. NPS grew over 20% year-over-year, driven by the launch of Flex. NPS grew internationally as well as pump sales increased in Europe on new sensor launches. Q1 CGM attachment rate was 69%, up 100 basis points from Q4 and an increase of 500 basis points year over year. As we launch our new products, we expect our CGM attachment rate to continue to trend upwards, as nearly every new Minimed pump user is using our CGM to get the benefit of our SmartGuard automation. Let me next talk about our readiness as a standalone company, including the progress we're making on TSA exits. As we've previously mentioned, we started with approximately 160 TSAs with Medtronic. Our dedicated teams have already exited 17 TSAs and continue to work alongside Medtronic to make significant progress across the remaining TSA portfolio. We remain confident that we'll exit these TSAs within the timelines we've established, most of which will occur in calendar 2027. Importantly, these efforts continue to enhance our standalone capabilities while reducing our reliance on transition services over time. And they are allowing us to build a more focused, efficient, and fit-for-purpose operating model for Minimed. Through this process, we continue to maintain a strong balance sheet and significant liquidity, ending the quarter with approximately $207 million of cash, no debt, and an undrawn $500 million revolver. As we continue to build out our standalone capabilities, we're also gaining increased visibility into the underlying cash generation profile of the business. Operating cash flow in the quarter was a use of cash of $49 million, and capital expenditures were $41 million. As a result, free cash flow was a use of cash of $90 million. As we've discussed previously, our near-term cash flow profile reflects separation in standalone company build-out activities that are not indicative of the ongoing cash generation of the business. To provide additional transparency, we've included a cash flow bridge in today's earnings presentation. Separation and stand-up related activities consumed $111 million of cash during the quarter. Excluding those items, we generated $21 million of positive free cash flow. We're providing this additional visibility to illustrate the underlying cash generation of the stand-alone business and the rapidly improving cash flow profile that we expect to emerge as temporary separation and build-out activities roll off. As we continue to execute our separation, exit TSAs, and benefit from higher revenue, profitability, and operating leverage, we expect cash generation to improve meaningfully over time. Next, let's cover our outlook for the remainder of fiscal 2027. Given our strong start to the year and execution across the business, we're raising our fiscal 2027 organic revenue growth outlook to approximately 10.5% from our prior guidance of approximately 10%. This outlook continues to include the expected 1 to 1.5 percentage points benefit from the Q1 extra week. Our increased revenue outlook is supported by accelerating growth in the U.S., strength in international markets and the successful execution of our recent product launches. We continue to see strong demand for MiniMed Flex and increasing adoption of our CGM sensors globally. As we look to Q2, reported growth rates will naturally normalize from Q1 as the extra-week benefit does not repeat. Importantly, based on the positive trends we continue to see in the business today, we would expect organic revenue growth in both the U.S. and international markets to be more comparable to the underlying growth rates we delivered in Q1, excluding the extra week. As I mentioned earlier, we are reaffirming our fiscal 2027 adjusted EBITDA margin guidance of approximately 16%. The underlying performance of the business remains strong. Gross margin is trending ahead of the assumptions embedded in our original outlook and is offsetting the foreign exchange impacts we experienced in Q1. Combined with the continued operating leverage across the business and our improved full-year revenue growth outlook, these factors support our confidence in delivering our Fiscal 27 EBITDA margin guidance. As we look at quarterly cadence, we continue to expect EBITDA margin expansion over the course of the year. We expect EBITDA margins to improve from Q1 levels as we move throughout Fiscal 27, with a larger portion of the improvement occurring in the second half of the year, similar to what we saw last year. This reflects building revenue and revenue growth contributions from our recent product launches, sequential gross margin improvement, and increasing operating leverage across the While we do not provide specific guidance in our key business metrics, we continue to expect growth in both new pumps sold and CGM attachment rates as we expand our installed base and continue rolling out our new products globally. For details on our guidance, see the guidance slide in our earnings presentation.
Hugh, back to you. Thanks, Chad. We're encouraged by the momentum we're seeing across the business. We delivered another quarter of strong growth, accelerated adoption of our newest products, and advanced our pipeline across multiple fronts. Most importantly, we continue to do what we said. Across both our commercial portfolio and pipeline, we are delivering against the commitments we made to investors and are doing so ahead of schedule. Two weeks ago, we announced that we began shipping Flex with the Instinct Sensor in the U.S., and today we shared several important updates with you. We submitted the Minimed Fit patch pump to the FDA ahead of our fall target, and we expect a full U.S. launch next summer. Minimed Flex received CE mark well ahead of our target of the end of the calendar year, and we expect full commercial launch starting in November of this year. We finish enrollment in our Vivera U.S. pivotal trial and expect U.S. launch in the second half of calendar 27. And we receive U.S. IDE approval for our next generation extended wear sensor with a pivotal starting this October. Taking together these milestones highlight both the pace of innovation at Minimed and our ability to consistently move the calendar to the left. More importantly, they reinforce the strategy we have been discussing for some time. We are building a complete platform for insulin-taking patients, smart pens, durable pump, patch pump, one algorithm, one app, one ecosystem. What excites me most is that all these pieces are starting to come together. Flex is expanding our reach into new patients and helping us engage with many new accounts. Go is opening the door to millions of people on multiple daily injections. Fit will bring our differentiated technology platform to the fastest-growing segment of the insulin delivery market. And Vivera has the potential to make automated insulin delivery simpler and more accessible. We believe the opportunity ahead remains significant. Automated insulin delivery remains greatly underpenetrated globally. Type 2 diabetes is still in the early stages of AID adoption. And millions of people continue to manage their diabetes with injections every day without the help of smart technology. We believe we're uniquely positioned to serve each of these populations with a broader portfolio, better outcomes, and a simpler user experience. As we do that, we believe we create long-term shareholder value. We are expanding our own store base. We are increasing recurring revenue streams. We are driving operating leverage. And we are investing behind the products and technologies that we believe will support sustainable growth for many years to come. Before we open the line for questions, I'd like to thank our employees around the world. This quarter, our team launched products, advanced clinical programs, expanded manufacturing capacity, increased patient access, and continued to deliver for customers while operating as a newly standalone company. Their commitment, dedication, and passion for the people we serve continue to be one of MiniMed's greatest strengths. We've talked today about growth, we've talked about innovation, and we've talked about execution. What gives me confident is that all three are moving in the right direction at the same time the opportunity remains large the roadmap is strong and our focus remains the same do what we say continue innovating and continue creating long term value for patients providers and shareholders with that let's go to Q&A operator thank you ladies and gentlemen just a question at this time you will need to press star 11 on your telephone and wait for your name to be announced.
Operator
To withdraw your question, simply press star 11 again. Please stand by when we compile the Q&A roster. Now, first question in queue coming from the line of Travis Stede with Bank of America. Your line is now open.
Hey, everybody. Congrats on the updates on the pipeline. I guess what would sit just the 20,000 at launch reiterated, if FIT gets approved early, could that 20,000 at launch still be the case? Are you going to be ready at launch no matter when the approval comes, and how does that scale over time? And for Vivera, what else is left between now and approval, any of the kind of key milestones that you need to complete? And when you have kind of both of those product portfolio in the portfolio, how do you think about new patient starts accelerating in this business?
Thanks, Travis. In terms of the fit launch volume capacity, we're working on that. We're focused on getting ready for commercial launch. Obviously, we run multiple scenarios. I think you've seen from our track record that we want to be prepared for, you know, if a happy event and things are early, that we're ready. So that's one of the scenarios that we run and so now we're running water through the pipes, making sure that our yields and output are there and we're already planning for additional capacity beyond the 20,000. On Vivera, we've completed enrollment, the study is three months and we're very excited with this trial, we're excited to see the data. So once the last patient is completed, we lock down the database. We obviously run a lot of analytics and prepare for the submission. But those are the steps. And I think the combination of the patch pump with a fully closed-loop algorithm is really a killer app in the market. And we think that the product would do extremely well. It's not just the patch form factor, but the fact that patients really without any input can achieve above the ADA guidelines.
Great. And Chad, maybe a follow-up on margins. I don't know any other color on the $8 million in investment this quarter on fit and flex acceleration that you'd provide. But more importantly, kind of moving forward, you're calling for gross margin expansion and more leverage on the P&L later in the second half of this year. Just give any other color and get building confidence in the margin expansion moving forward would be helpful.
Yeah, of course. From an investment standpoint, we felt it was important for us to really support our innovation and the pull forwards that we've seen with both Flex and Fit. So, for example, for Fit, we used $4 million with outside vendors to help accelerate the submission. And they do things like, you know, um actually testing um the units and validation so things that we can use third parties to accelerate our submissions for we actually use those and brought those brought those in a bit early to make sure that we hit that early submission date that we wanted to do and then from a flex investment standpoint we wanted to make sure since we pulled it forward we went out as strong as possible and did things with sales and marketing with ads and online where you can do investments and pull those in we did another four million and things of that sort so very targeted, very specific monies that we were going to spend in the next quarter or so that will not repeat, so they do not have an impact on the full-year EBITDA. And then from a gross margin standpoint, yeah, we're very happy, excited by the progress we've seen on two fronts. First is on Simplera. You know, we've talked about how Simplera will have a negative impact on the margin for the current year, but we're seeing better yields than we had anticipated initially. We're doing a lot of work from a manufacturing side, and that's resulting in better yields. So the second half of the year will have better gross margins, and also our warranty expense is much better than we expected as product reliability goes up. So things that we have clear line of sight to that gives us confidence in those numbers.
Great. Congrats on a good quarter.
Thanks, Travis. We'll take the next question, please, Olivia.
Operator
Our next question coming from the line of Patrick Wood with UBS, Yolanda Snellson.
Beautiful. Thank you so much. I'll keep it just to one. Were you guys surprised by the incremental pump shipments following Instinct? I mean, you mentioned the UK and that side of things. And I guess the way I'm sort of thinking about it is looking forward and thinking about Flex, Vivera, and everything else like that. Do you think the ability to take share of patients is perhaps faster than you might have thought otherwise? Or put another way, people are just more willing to switch than maybe we have thought when you have a better solution in the market.
Thanks. Patrick, I think, look, the market's expanding. And I think if we just look at the data that we're seeing in the U.S. for Flex, we are seeing the majority of new customers coming from MDI. So that shows you that's an expanding market. What we've also seen is that our competitive conversions, both from tube and tubeless systems, have doubled versus a year ago. So that's very encouraging from building the in-store base. and we expect a similar experience when Flex is launched in November in Europe. Obviously, new CGMs help that as well. That's been our Achilles heel for a very long time, but the new form factors coming out there, that's also driving pump growth. When you look at new pumps sold in the US, as an example, up 20%, another indicator I would say that's very consistent is the number of prescribers riding Minimed Flex is up 24%. So when we look at all these indicators, they are moving in the same direction. And so I think NetNet, with all these new products coming out, we believe our ability to drive share gains as well as growth in the expanding market is enhanced.
Thanks, Q. Thank you, Patrick. We'll take the next question.
Operator
Our next question comes from Lauren Stigelson with Mosvargo. Your line is now open.
Good morning. Thanks for taking the question. Congrats on the nice quarter here. Two for me, I'll ask up front. Just one on Minimet Fit. How are you thinking about deferrals ahead of the launch? We saw a little bit with Flex. And second, Q, could you please, given that, I think you said over 40% or 40% of new starts, are type 2. Just give us a little more color on type 2 attrition. You know, how does it compare to type 1? You know, why do you think your retention, you know, would be higher than one of your competitors? Thank you.
Larry, on FIT, the waiting mode, we actually think that FIT will address the new segment of patients that want a patch form factor. I think if you look at our store base, I'm sure some of them may want a patch, but the reality is if they wanted a patch, they would have gone to a patch by now. So we think that MDI patients and people who really like that form factor will be new to MiniMed, and that's what FIT will address. On your question about type 2 attrition, I would say a couple things. One is we've seen our retention improve quite a bit from both type 1 and type 2 versus, say, a few years ago, and that's really driven by two things. One is, obviously, the new product innovations help that a lot. You need to have that. But that's a necessary but not sufficient condition. We have a very large clinical team. And for years, we run a program called Start Right. It's really helping customers onboard to therapy very quickly and that they're successful on therapy through sensor changes and troubleshooting with strategic touch points. And then we have a Stay Right program that also, again, from six months to, you know, four years, we also keep in touch with them because this is a long, you know, lifelong relationship and we want them to do well. And so the programs, in addition to the innovation, really helped us improve retention and we're not seeing anything alarming at all from an attrition standpoint in type 2. If anything, it's improved. And then I would also say that the product portfolio we have with the larger reservoir, the longer wear, it really has a better product market fit with type twos, which is why we're excited with fits. We're excited with the outcomes, but also just, I think we're the only, you know, patch pump coming to the market with a 300 unit reservoir.
Thank you. Thanks, Larry. Next question, please.
Operator
Our next question coming from the line of Mary Tipoff with U.S. Bank of PTIG, Yelena Sulton.
Hi, thank you for squeezing the OUS launch of FLEX that we'll have coming up here in November. Just how should we think about that ramp relative to the U.S. experience and then, again, I guess the question of potential deferrals as maybe patients look forward to that pump in the next fiscal quarter. Thanks for taking the question.
Yeah, let me take the first part. It would be similar to the U.S. We have plenty of capacity. We typically roll out in waves of countries, and we expect that we'll have a very similar Again, it starts, the launch will be with Simplera initially, followed by Instinct. And then, Chad, maybe you can comment on the waiting mode.
Yeah, so we've actually incorporated waiting mode into our forecast for OUS. One of the things that we do have with OUS having such a variety of different countries, We have a very strong quarter starting in certain Western European countries, given the adoption and integration of instinct. So we have a lot of momentum right now in certain countries, which is really putting us off to a strong start to this quarter, which helps us offset some of the waiting mode that we may see, which we've incorporated in our forecast.
Thanks, Marie. I think we're going to take two more questions here. So we'll go to the next question, please, Livia.
Operator
Next question coming from the line of Anthony Petronium with Mizuha Group. Here line is now open.
Hey, guys. This is Dimitri on for Anthony. Once again, congrats on the quarter. It's good to see, you know, the performance and growth in the U.S. But I have a quick one on international. I know last quarter you gave some color on new pump starts quarter on quarter with high single digits. I don't know if it was you're providing any color for that quarter-on-quarter growth this quarter. And, you know, I know at least one of your competitors are increasing their efforts in the international arena. And I wanted to know if you're seeing any competitive pressures there with, you know, new pump starts attrition.
Yeah, I think, look, we are very encouraged with new pump starts. I think in the commentary, we mentioned that in France, pumps were up 20%, in the UK up 50%, and these are contested markets. So CGM is having an impact, and I think the flex pump is eagerly anticipated as well. It will be the first upgrade in six years, and so we expect it to do incredibly well even in contested markets.
Okay, sounds great. Just a quick follow-up. I know you guys said you expect a ramp, have mini-med fit at full launch, mid-27. So is the timing for approval, you know, what are you guys expecting, like a three-month or a six-month approval and then kind of just to get an idea of the taste of the ramp?
We can't really predict what the agency process will be. We're always hopeful for, you know, early approval, of course, but that's not something we can predict. But, you know, as I mentioned, we always plan for different scenarios, and we want to be ready. As soon as approval comes, we'll be ready to launch commercially.
Okay, great. Thanks for the time.
Thanks, Dimitri. Livia, we'll take our last question, please.
Operator
Last question, and we'll come from the line-up. Joanne Wich with City, Yelena, Melbourne. Good morning.
Thank you for taking the question, and nice quarter. Based on your commentary for summer of 27 FDA approval, it sounds like your milestone payment will be more of a first quarter fiscal year 28 than a second quarter fiscal year 28 event. Can you just confirm if I'm thinking about that correctly? And then just a quick follow-up, which is if your physicians are talking to patients and they have to talk about the new flex option and FIT coming, how do you guide or suspect that they are having those conversations? Thank you.
First, in regarding to the FIT charge, yes, we do not have it in our fiscal year 27 because, as Q said, we can't predict when the agency will approve. But obviously, once they do approve, just like with flex, you know, we'll announce that And then we will, once we commercialize, we'll have a $162 million charge for fit. But that is not in our forecast for this year.
Joanne, I think, look, I've done a lot of visits in the field. I would say there's just renewed interest starting with CGM. We saw just excitement around that, you know, and with FLEX coming out, again, an uptick in interest. then I suspect that, you know, there's going to be a large addressable audience from a patch pump standpoint that love our algorithm, they want to be part of our ecosystem, but they want the patch form factor. And we'll have that starting with SmartGuard, but with a quick follow with Vivera. So we're really excited with really the rolling thunder that's coming out and, you know, the full stack experience they're going to have. The other thing I'll mention is the apps that you get from Minimed Go, from Flex, very similar look and feel. And so that really helps users when they onboard into our system to stay within our ecosystem.
Okay. Thank you, Joanne. And for those analysts we didn't get to today, we're happy to follow up with you after the call. I'd also like to thank everyone for joining us today and for your continued interest in Minimed. We appreciate the engagement and thoughtful dialogue as we continue to execute against our roadmap. We look forward to updating you on our progress and sharing more color with you on our Q2 earnings call later this fall. So with that, thank you for your time today and have a great rest of your day.
Operator
This concludes the conference call. Thank you for your participation. You may now disconnect.
