MiniMed Group, Inc.

Good day and welcome to Minimed's first quarter and fiscal year 2027 earnings webcast. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. Instructions will be filed at that time. Today's call is being recorded. I will now hand the conference over to your speaker host, Ryan Weispfenning, VP of Investillations. Please go ahead.

Hello, everyone, and thanks for joining us today for our Fiscal 27 First Quarter Earnings Webcast. I'm Ryan Weispfenning, Vice President and Head of Mini-Med Investor Relations. Joining me today are Que Dallara, 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 that provides additional details on our performance. Both can be accessed on our website at investors.minimed.com. 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 included in our earnings press release and the presentation. Additional information concerning factors that could cause our actual results to differ is contained in the periodic reports and other filings we make with the SEC. Forward-looking statements speak only as of the date they are made, and we do not undertake to update any forward-looking statement or any of the information contained in today's program. In today's program, unless we say otherwise, all comparisons are made on a year-over-year basis, and references to revenue growth are to organic revenue growth, a non-GAAP financial measure. A reconciliation of organic revenue growth 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 the 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, so our GAAP financial statements for historical periods were prepared on a carve-out basis and include certain historical cost allocations from Medtronic for centralized support functions. On today's program, unless we say otherwise, year-over-year and sequential comparisons of P&L line items will be made to historical period financials that are presented on an adjusted standalone basis, which replaced historical midtronic cost allocations with the expected run rate cost structure for standalone mini-med. This information also eliminated the impact of certain incremental non-recurring costs. These standalone P&L items are non-GAAP financial measures, and 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.

Thank you, Ryan, and hello, everyone. It's good to be speaking with you today to update you on the momentum we have at MiniMed with our commercial growth Our innovation pipeline and our execution. We had an excellent start to our fiscal year in our first full quarter as a standalone public company. Organic growth was 16% and ahead of expectations. The extra week in our fiscal calendar contributed approximately four to six points of that growth. Excluding it, we grew low double digits, an acceleration of roughly a couple hundred basis points from Q4 and ahead of the outlook we gave you in June. Our U.S. growth accelerated on the strength of our MiniMed Flex with Simplera launch, which started shipping late June and represented about five weeks of shipping for the quarter. In our international region, we delivered another quarter of double-digit growth as we significantly increased sensor supply to meet strong customer demand, increasing Simplera supply throughout the quarter and launching Instinct with MiniMed 780G in July, well ahead of the calendar 2020 27 timeframe we outlined during our IPO Roadshow. We also advanced four separate pipeline programs. We are releasing next generations of every part of our integrated system, sensors, insulin delivery devices, algorithms, and apps. We are not launching individual products. We are building the next generation of MiniMed, one company, every option, one ecosystem. Now looking at our Q1 growth in more detail, starting with the US, last quarter we told you to expect an acceleration in revenue growth from Q4, and we delivered. US revenue grew 13%, up from 1.5% in Q4. Excluding the extra week, US growth was in the high single digits. In addition, US new pumps sold increased by over 20% year over year. This was driven largely by the launch of the MiniMed Flex insulin pump system, which started shipping in late June with our Simplera sensor. The majority of Flex sales are going to MDI patients that are new to pump therapy, followed by conversions from tubed and tubeless competitor systems, all of which grow our install base. Importantly, Flex is doing exactly what we designed it to do. It is expanding our reach into new patients, driving competitive conversions and strengthening our position in AID. The reason is simple. Patients have been telling us for years what they wanted, the outcomes of MiniMed in a simpler, smaller, more discreet form factor with the convenience of app control. And MiniMed Flex is doing exactly that. Our new small insulin pump is half the size of the MiniMed 780G and our leading SmartGuard adaptive algorithm The most clinically validated algorithm in the world. The early patient response to FLEX has been very encouraging. We're seeing strong engagement in social media and hearing directly from patients who are excited about FLEX's sleek and discrete form factor. And patients, pediatrics, and people with type 2 especially, appreciate FLEX's large 300-unit insulin reservoir and our long-lasting 7-day extended infusion set. and the strong outcomes they get with our SmartGuard algorithm. Physicians are responding to FLEX as well, particularly with the simplicity of the setup. We're seeing that interest translate into a broader and growing prescriber base with new MiniMed prescribers up 24% year over year. We're still in the early innings of the FLEX US launch with a strong growth runway in front of us. Late in Q1, we expanded the availability of Flex to Medicare and Medicare Advantage beneficiaries. And two weeks ago, on August 17th, we announced that we started shipping MiniMed Flex with the Instinct sensor, a combination that many patients have been waiting for. In Q1, we also began the U.S. launch of MiniMed Go, our smart MDI solution that remembers, reminds, and recommends and can help us reach more than 2.5 million people in the U.S. who are using multiple daily injections. We are in the early stages of that launch. Our dedicated primary care sales force was fully deployed near the end of Q1 and is now gaining traction at target accounts, many of which are new to MiniMed. Providers are prescribing MiniMed Go directly from their EMR to MiniMed Pharmacy where we handle the billing and ship directly to the patient. Encouragingly, more than half of orders to date have come from patients who are new to MiniMed, reinforcing our ability to expand beyond our traditional customer base. Through our smart pen, CGM, and connected app, MiniMed Go serves as a new entry point to the MiniMed ecosystem. We're also beginning to see early examples of patients progressing to our AID therapies, reinforcing our vision of MiniMed Go as both a meaningful MDI opportunity in its own right and a pathway to our AID therapy for those who prefer to advance their care. Now let me spend a moment on Type 2 because it represents one of the largest opportunities in AID and we believe we're still at a relatively early stage in realizing its full potential. It's also an area where analysts and investors have had questions, particularly around long-term adoption and retention. Importantly, the trends we're seeing in our own data are very encouraging. As we've discussed previously, approximately 40% of new starts in the U.S. come from type 2 patients, and that trend continues into Q1. In addition, we continue to see retention improve over time across both type 1 and type 2 patient populations. We believe that reflects the strength of our differentiated insulin delivery devices which have specific features geared at Type 2 patients and their physicians. Flex and Fit both have 300-unit insulin reservoirs and up to seven days of wear. Plus, a plus for Type 2 patients that typically require more insulin than Type 1 patients and benefit from fewer change-ups. We also designed our algorithms to be easier to use which helps both patients and their physicians. And that's evident already today Real-world data was published on over 6,500 Type 2 patients using our SmartGuard algorithm in diabetes care earlier this year, which show that these Type 2 users achieved on average time in range well above the ADA guidelines without bolusing, in effect running in fully closed loop. Within this cohort, Those Type 2 users that used our recommended settings achieved a time and range of 82%, a remarkable 12 points above ADA guidelines. We expect Vivera, our fully closed-loop algorithm currently under study, to build on this foundation and reduce burden placed on both patients and providers. Turning to international, we grew 16.9% organic, including the benefit of the extra week. Excluding it, we grew low double digits. This was a strong, broad-based growth across pumps, sensors, and consumables. Importantly, this growth is occurring in markets where automated insulin delivery remains significantly underpenetrated and where our commercial infrastructure, reimbursement capabilities, and clinical evidence are real advantages. In many of these markets, we believe the AID opportunity is still ahead of us. We had notable strength in Western Europe, our largest international market, which grew in the high teens. These are contested markets, and our new products are performing very well in them. European growth this quarter was driven by increased availability of new sensors, which is driving both strong CGM growth and strong pump revenue growth. Our Simplera sensor supply increased by three times versus last year, and this is making an impact in countries like France, where our pump sales increased over 20%. In addition, we began our European commercial launch of the Instinct 15-day sensor at the start of July. As a reminder, this allows us to reach more than 4.5 million Abbott sensor users on intensive insulin therapy and bringing them into the MiniMed ecosystem. In the countries where Instinct has launched, we're seeing meaningful increases in pump sales, including over 50% growth in the United Kingdom. Q1 was also our first full quarter of our European launch of Minimed Go, which resulted in several MDI tender wins. Now turning to our pipeline, which represents the next phase of our growth. Earlier today, we announced that Minimed Flex received CE mark approval well ahead of our calendar year end target, and we now expect to begin our European launch in November of this year. We've also advanced two significant products that will come to the U.S. market next. MiniMed Fit, our patch pump, and Vivera, our fully closed-loop algorithm. Both are expected to be on the market in calendar year 27, at which point we will have completely upgraded every aspect of our product portfolio with a full offering across every form factor for insulin-taking patients. Starting with MiniMed Fit, we have an important update to share with you today. We completed the 510k filing for Fit with FDA, ahead of our four targets, and we now expect a full US launch by summer next year. Fit brings MiniMed's differentiated therapy platform to the fastest growing segment of the insulin pump market. Patients should not have to choose between convenience and outcome, and Fit is designed to deliver both. FIT combines several important advantages including the only 300 unit reservoir on a patch pump, up to seven days of wear, waterproof design, persistent Bluetooth connectivity, iOS and Android availability from day one, seamless integration with both Simplera and Instinct, and importantly, access to our industry-leading algorithm. We believe many patients are simply Not looking for the convenience of just a patch pump, they're also looking for the best outcomes. FIT will pair a highly differentiated patch platform with our SmartGuard algorithm at launch and a simple over-the-air upgradeability 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 enrolment in our US 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 MiniMed is the only company with a fully enrolled US pivotal trial for 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 placed on both patients and providers. We expect to have Vivera on the US market in the second half of calendar year 27 for both MiniMed Flex and MiniMed Fit users. Vivera 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' AIG systems that still rely on meal announcements, all-calc 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 timely 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% timing 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 the various 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 install 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 MiniMed 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 and improve 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, I'll turn it to Chad to walk through the Q1 financials and our guidance.