MiniMed Group (NASDAQ:MMED) reported fiscal 2027 first-quarter revenue of $843 million, with organic revenue growth of 15.8%, as demand for its newer insulin-delivery and continuous glucose monitoring products supported growth in the United States and international markets.
Chief Executive Officer Que Dallara said the quarter marked the company’s first full quarter as a stand-alone public company. Organic growth included an estimated four to six percentage-point contribution from an extra week in the company’s fiscal calendar. Excluding that benefit, MiniMed said revenue grew at a low-double-digit rate, compared with 8.7% growth in the prior quarter.
U.S. growth accelerated with Flex launch
Dallara attributed the improvement largely to the launch of the MiniMed Flex insulin pump system with the Simplera sensor, which began shipping in late June and contributed about five weeks of shipments during the quarter. U.S. new pumps sold rose more than 20% year over year, while MiniMed said its number of new prescribers increased 24%.
The company said most Flex sales were going to multiple daily injection, or MDI, patients who were new to pump therapy, followed by conversions from competing tubed and tubeless systems. Dallara said the product’s smaller design, app control, 300-unit reservoir and seven-day extended infusion sets have been areas of interest for patients, including pediatric and type 2 diabetes populations.
MiniMed expanded Flex availability to Medicare and Medicare Advantage beneficiaries late in the quarter. It also began shipping Flex with the Instinct sensor in the U.S. on Aug. 17, Dallara said.
The company additionally began the U.S. launch of MiniMed Go, its smart MDI offering. More than half of orders to date have come from patients new to MiniMed, according to Dallara. The product is prescribed through electronic medical records and fulfilled through MiniMed Pharmacy.
International sales and recurring revenue
International organic revenue grew 16.9%, or low double digits excluding the extra week. Western Europe, MiniMed’s largest international market, grew in the high teens, Dallara said.
Sensor availability contributed to international performance. Simplera sensor supply increased threefold from the prior year, and the company cited pump-sales gains of more than 20% in France. MiniMed began the European commercial launch of its Instinct 15-day sensor in July and said pump sales in the United Kingdom rose more than 50% in countries where Instinct has launched.
Chief Financial Officer Chad Spooner said pumps grew in the low 20% range and CGM grew in the high teens during the quarter. Consumables grew at a low-double-digit rate. CGM and consumables represented 82% of revenue, he said, providing a recurring source of sales.
New pumps sold totaled 34,000, up 7.7% year over year. The CGM attachment rate reached 69%, improving 100 basis points sequentially and 500 basis points from a year earlier.
Margins, cash flow and outlook
Adjusted EBITDA was $83 million, for an adjusted EBITDA margin of 9.9%. Spooner said the margin included roughly 230 basis points of impact from accelerated planned investments and a foreign-exchange remeasurement charge.
MiniMed pulled forward about $8 million of investments supporting the Flex launch and accelerated submission of its Fit patch pump to the Food and Drug Administration. The company also recorded a $12 million foreign-exchange remeasurement charge on balance-sheet items. Excluding those items, adjusted EBITDA margin would have been 12.2%, Spooner said.
Adjusted gross margin was 55.9%, ahead of the company’s expectations. Spooner said Simplera manufacturing yields were trending better than MiniMed had previously anticipated, while warranty expense was also lower than expected.
Operating cash flow was negative $49 million, and capital expenditures totaled $41 million, resulting in free cash flow use of $90 million. However, MiniMed said separation and stand-alone company build-out activities consumed $111 million during the quarter; excluding those activities, it generated $21 million of positive free cash flow.
The company ended the quarter with approximately $207 million in cash, no debt and an undrawn $500 million revolving credit facility. It has exited 17 of approximately 160 transition service agreements with former parent Medtronic, with most remaining exits expected during calendar 2027.
MiniMed raised its fiscal 2027 organic revenue growth outlook to approximately 10.5% from approximately 10%. The outlook includes the expected one to 1.5 percentage-point benefit from the extra fiscal week. The company reaffirmed its forecast for an adjusted EBITDA margin of approximately 16% for the year, with the larger portion of expected margin improvement occurring in the second half.
Pipeline updates
MiniMed said Flex received CE mark approval and is expected to begin its European launch in November. The company also completed its 510(k) filing with the FDA for the MiniMed Fit patch pump ahead of schedule and expects a full U.S. launch by summer 2027, subject to regulatory approval.
Dallara said Fit will launch with the company’s SmartGuard algorithm and is designed to support a 300-unit reservoir, up to seven days of wear, waterproofing, persistent Bluetooth connectivity, and iOS and Android availability. MiniMed expects to have manufacturing capacity for 20,000 patients at launch and said it is preparing additional capacity.
The company also completed enrollment ahead of schedule in its U.S. pivotal trial for Vivera, its fully closed-loop algorithm. MiniMed expects a U.S. launch in the second half of calendar 2027 for Flex and Fit users. Dallara said the algorithm is intended to operate without meal announcements and requires a patient’s total daily insulin dose to begin.
Finally, MiniMed received FDA investigational device exemption approval for a next-generation extended-wear sensor and expects to begin its pivotal trial in October. The company did not disclose the target wear duration or specific sensor features.
About MiniMed Group (NASDAQ:MMED)
We are a scaled global medical technology company that develops, manufactures, and markets a comprehensive suite of solutions for the management of diabetes. Since our founding more than 40 years ago, we have pioneered groundbreaking innovation and served the needs of our customers across the globe in service of our mission to make every day a better day for people with diabetes. Today, we are the only player in the market that commercializes all parts of an integrated diabetes management system.
