Earnings Call Transcript - MMED Q1 FY2026

Operator

Good, Dan. Thank you for standing by. Welcome to the MiniMed fourth quarter in 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 of icing your hand is raised. To withdraw your question, please press star 11 again. Please be advised, today's conference is being recorded. I would like to hand the conference over to your speaker today. Ryan Weisfenning, head of MiniMed Investor Relations,

Ryan Weisfenning, Head of Investor Relations

please go ahead. Hello, everyone, and thanks for joining us today for our fiscal 26 fourth quarter earnings webcast. I'm Ryan Weiss-Penning, Vice President and Head of Minimet Investor Relations. Joining me today are Q 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 to our website 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, 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 MINIMED. This information also eliminates the impact of certain incremental non-recurrent 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.

Q Dallara, CEO

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 Minimed. Before we go into the details, let me start with who we are and why we exist. Minimet 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 life. 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 were 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 expectation, and I want to be clear about what drove it. FTA clearance of MiniMedFlex 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 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 Minimet 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. Minimet Fit, our next generation patch pump, and Vivera, our fully closed-loop algorithm for Type 1 and Type 2, 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 Simplera availability drove a high single-digit sequential increase in new pumps sold, or NPS, and 100 basis points, 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 U.S., with the context on overall U.S. performance that I covered earlier, let me walk you through two components, CGM and PUMP, because the underlying dynamics in each tell an important story about where this business is heading. U.S. CGM revenue grew high single digits in Q4, our first full quarter with both Simplera and Instinct available. Since launching both sensors in Q2, U.S. CGM 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. U.S. NPS were up year-over-year and up mid-single digits sequentially, a leading indicator of where U.S. revenue is heading. And here's why I'm confident about fiscal 27. Census weather setup, Minimed Go and Flex are the follow-through. Minimed Go launched two weeks ago. providers can prescribe directly from their EMR to Minimet Pharmacy and the product is shipped directly to patients. Pre-orders for Minimet 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 smarts of 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 MGI 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 would 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 week.