INSULET Q1 FY26 earnings call PODD

Insulet reported strong U.S. growth in Q1 FY26, reinforcing market leadership. New customer starts increased year-over-year, driven by AID adoption for type 2 and positive pricing. However, sequential decline was observed due to higher-than-normal Q1 seasonality, attributed to annual deductible resets. Management noted improving month-on-month trends into April, suggesting a temporary headwind^📎. The company continues to expand its type 2 customer base, supported by prescriber education and ADA guideline updates, with access improvements benefiting an additional 16 million lives.

The international business delivered another standout quarter with 45% constant currency revenue growth, marking the third consecutive quarter above 40%. This growth was driven by strong year-over-year and sequential new customer starts, along with favorable price/mix from the transition from DASH to Omnipod 5. Key European markets like the U.K., France, and Germany showed robust performance. Insulet secured improved reimbursement and new coverage for Omnipod 5 across four Canadian provinces, reaching 85% market approval, and plans to launch Omnipod 5 in Spain in H2 FY26.

Innovation remains a core driver, with the launch of a second-generation algorithm and Libre 3 Plus sensor integration planned for this quarter. The algorithm enhancements are expected to deliver approximately 5% improvement in time in range with a new 100 mg/dL target glucose setting and increased time in automated mode. Insulet is increasing R&D investments to advance its sixth-generation Omnipod, paired with a third-generation algorithm, planned for launch in 2027. Data from the STRIVE pivotal study for Omnipod 6 will be shared at ADA in June.

Insulet is making progress on a transformative fully closed loop system for type 2 diabetes, designed to be the first of its kind with no boluses and minimal user interaction. Feasibility study results presented at ATTD showed 68% time in range without boluses. The company enrolled its first participant in the EVOLVE pivotal study last week, aiming for FDA filing next year (2027) and launch in 2028. This system targets the large type 2 TAM by offering a CGM-like experience to unlock the primary care physician audience.

Insulet is investing in building a top-notch team and commercial capabilities, including appointing Mike Panos as Chief Commercial Officer. The company is expanding its sales force in Q2 FY26, upskilling them to sell clinically, and improving targeting. Efforts to increase access and remove prior authorization requirements resulted in a 4% net access improvement in Q1, benefiting 16 million lives. The Omnipod brand, recognized as the most prominent in the category, continues to drive awareness and new user engagement, as highlighted by its feature on the TV show 'Scrubs'.

Scaling global manufacturing and operations remains a priority, with a focus on quality, reliability, and customer safety. The company rapidly responded to a voluntary medical device correction in March, implementing targeted fixes. Insulet continues to ramp capacity and automation investments in Acton, Malaysia, and Costa Rica to support future growth, with the Costa Rica facility expected to go live in 2029. The ability to manufacture disposable electromechanical devices at consumer scale and medical quality is considered a strategic and financial advantage, contributing to market-leading gross margins.