Modular Medical (MODD) Q4 2025 earnings summary

Executive summary

• Pre-revenue medical device company focused on innovative insulin pumps for diabetes care, targeting both type 1 and type 2 markets.

• Received FDA clearance for MODD1 pump in September 2024; initial shipments planned for Q2 FY2026.

• Developing Pivot, a tubeless patch pump, with FDA submission expected by October 2025 and potential clearance in Q1 2026.

• Significant market opportunity identified among “Almost Pumpers” who are dissatisfied with current pump options.

Financial highlights

• No revenue reported for FY2025; company remains pre-revenue.

• Net loss for FY2025 was $18.8 million, compared to $17.5 million in FY2024.

• Research and development expenses increased 14.1% year-over-year to $14.7 million.

• General and administrative expenses decreased 6.4% year-over-year to $4.4 million.

• Cash and cash equivalents at March 31, 2025 were $13.1 million.

• Accumulated deficit reached $84.8 million as of March 31, 2025.

Outlook and guidance

• Initial commercial launch of MODD1 planned for a single U.S. region in Q2 FY2026.

• Pivot product FDA submission targeted by October 31, 2025, with clearance and launch expected in Q1 2026.

• CE mark clearance for European markets anticipated in Q1 2026.

• R&D and G&A expenses expected to increase in FY2026 as commercialization efforts ramp up.

• Substantial doubt exists about ability to continue as a going concern without additional capital.