Detailed narrative
Q1 Performance Highlights
MiniMed reported 16% organic growth in Q1 FY27, exceeding expectations. This included a 4 to 6 percentage point benefit from an extra week in the fiscal calendar. Excluding this benefit, organic growth was in the low double digits, accelerating by approximately 200 basis points from Q4 FY26. The U.S. business grew 13%, while international markets delivered strong 16.9% organic growth. This performance was driven by both pump and CGM sales, which grew in the low 20% and high teens, respectively.
U.S. Product Launches and Market Expansion
The U.S. saw a significant acceleration in revenue growth, with new pump sales increasing over 20% year-over-year, primarily due to the launch of MiniMed Flex with Simplera in late June. Flex is successfully expanding reach into new patients, with the majority of sales going to MDI patients new to pump therapy, and driving competitive conversions. The company also began the U.S. launch of MiniMed Go, a smart MDI solution, which has seen over half of its orders from patients new to MiniMed, serving as an entry point to the ecosystem.
Focus on Type 2 Diabetes
Type 2 patients represent a significant opportunity, with approximately 40% of new U.S. starts coming from this population. MiniMed's retention rates for both Type 1 and Type 2 patients have improved over time⏳, attributed to differentiated insulin delivery devices like Flex and Fit, which feature 300-unit insulin reservoirs and 7-day wear, catering to Type 2 needs. Real-world data for SmartGuard algorithm users showed Type 2 patients achieving an average time in range of 82% with recommended settings.
International Growth Drivers
International markets demonstrated strong, broad-based growth, particularly in Western Europe, which grew in the high teens. This was fueled by a 3x increase in Simplera sensor supply compared to last year, leading to notable pump sales increases (e.g., France up 20%, UK up 50%). The European commercial launch of the Instinct 15-day sensor also contributed, expanding reach to over 4.5 million avid sensor users on intensive insulin therapy.
Pipeline Advancements and Regulatory Milestones
MiniMed achieved several key pipeline milestones ahead of schedule. MiniMed Flex received CE Mark approval, with European launch expected in November. The 510(k) filing for MiniMed Fit, a patch pump, was completed ahead of target, with U.S. launch anticipated by summer next year. Enrollment in the U.S. pivotal trial for Vivera, the fully closed-loop algorithm, was completed ahead of schedule, with U.S. launch expected in the second half of calendar year 2027.
Next-Generation Sensor Development
The company's next-generation MiniMed extended wear sensor received IDE approval from the U.S. FDA, with a pivotal trial scheduled to begin in October. This sensor incorporates a new chemistry sensing platform and is expected to improve user experience, leverage existing manufacturing platforms for scale and margin expansion, and strengthen MiniMed's competitive position by offering longer wear duration.
Financial Performance and Outlook
Q1 revenue was $843 million, with adjusted EBITDA of $83 million. The adjusted EBITDA margin of 9.9% was impacted by $8 million in accelerated investments and a $12 million non-operational FX remeasurement charge. Excluding these, the margin would have been 12.2%. Adjusted gross margin was 55.9%, ahead of expectations, with Simplera yields trending better than modeled. The company reaffirmed its FY27 adjusted EBITDA margin guidance of 16%, expecting expansion in the second half due to building revenue, gross margin improvement, and operating leverage.