Sep 1, 2026 earnings call — Product launches and fiscal Q1 results
Q1 revenue was $843 million, with organic growth of 15.8% and adjusted EBITDA margin of 9.9%.
Revenue $0.8B (est $0.8B) · EPS $0.12 (est $0.12)
Key quotes
"we are releasing next generations of every part of our integrated system, sensors, insulin delivery devices, algorithms and apps."
"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 installed base."
"As I mentioned earlier, we are reaffirming our fiscal 2027 adjusted EBITDA margin guidance of approximately 16%."
Analyst Q&A 6
Fit launch capacity and Vivera steps
Q (Travis Steed · BofA): They asked if a 20,000 launch for Fit still holds if approval comes early, whether the company will be ready and how it will scale. They also asked what remains before Vivera approval and what milestones are next, and how both products will affect new patient starts.
A: Management said they run multiple scenarios and are preparing for early approval, testing yields and planning additional capacity beyond the 20,000. They said Vivera enrollment is complete, the study is 3 months, and after the last patient they will lock the database, run analytics and prepare the submission. Management also said they spent $4 million on outside vendors for Fit and $4 million on Flex sales/marketing as targeted, one-time investments, and that manufacturing yields and warranty trends give confidence in better gross margins in the second half.
"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." — Que Dallara (CEO)
Market share and switching behavior
Q (Patrick Wood · UBS): They asked whether the company was surprised by incremental pump shipments after Instinct and whether patients switch faster to a better solution, helping the company take share.
A: Management said the market is expanding and that the majority of new U.S. customers for Flex are coming from MDI, showing expansion into a new pool of users. They also said competitive conversions have doubled versus a year ago, prescribers writing MiniMed Flex are up 24%, and new pumps sold in the U.S. are up 20%, all pointing to stronger share gains and growth.
"What we've also seen is that our competitive conversions, competitive conversions systems, have doubled versus a year ago." — Que Dallara (CEO)
Fit deferrals and Type 2 retention
Q (Larry Biegelsen · Wells Fargo): They asked whether patients are deferring purchases ahead of Fit's launch and for more color on Type 2 attrition versus Type 1 and why retention might be higher.
A: Management said Fit should attract new patients who want a patch form factor and that many MDI patients will be new to MiniMed. They said retention for both Type 1 and Type 2 has improved, driven by new product innovations and large clinical programs like StartRight and [ StayRight ], and that product fit (larger reservoir, longer wear) supports better retention for Type 2s.
"And then we have [ StayRight ] program that also, again, from 6 months to 4 years, we also keep in touch with them because this is a long -- lifelong relationship, and we want them to do well." — Que Dallara (CEO)
Europe launch ramp and patient waiting
Q (Marie Thibault · U.S. Bank of BTIG): They asked how the out-of-U.S. (OUS) November launch of Flex should ramp relative to the U.S., and whether patient deferrals (waiting mode) will affect that ramp.
A: Management said the OUS ramp should be similar to the U.S., with plenty of capacity and country-by-country rollouts, starting with Simplera then Instinct. They also said they have incorporated waiting mode into their OUS forecast and expect strong quarters in specific Western European countries to help offset waiting-mode effects.
"So we've actually incorporated waiting mode into our forecast for OUS." — Chad Spooner (CFO)
International growth and approval timing
Q (Mizuho Group): They asked for color on international new pump starts and whether competition is pressuring starts or attrition. They also asked what approval timing they expect and how long ramp to full launch might take.
A: Management said they are encouraged by new pump starts internationally, noting pumps were up 20% in France and up 50% in the U.K. in contested markets, and that CGM and Flex anticipation are driving growth. On approval timing, they said they cannot predict the agency process, remain hopeful for early approval, and plan for multiple scenarios so they can launch as soon as approval occurs.
"I think, in the commentary, we mentioned that in France, pumps were up 20%; in the U.K., up 50%, and these are contested market." — Que Dallara (CEO)
Milestone timing and doctor conversations
Q (Joanne Wuensch · Citi): They asked whether the milestone payment timing implies the payment will fall in fiscal Q1 2028 versus Q2, and how physicians are talking to patients about Flex and upcoming Fit.
A: Management said they do not include the Fit charge in fiscal year '27 because they can't predict agency timing, and that once approved and commercialized there will be a $162 million charge for Fit but that is not in this year's forecast. They also said doctors show renewed interest driven by CGM and Flex, that there is a large audience for a patch pump, and that similar apps and ecosystem experience will help patients stay with MiniMed.
"But obviously, once they do approve just like with Flex, 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." — Chad Spooner (CFO)