Senseonics Holdings, Inc. Q1 FY2025 earnings call

• Integration of Eversense 365 with Sequel's twiist automated insulin Delivery System to enable real-time CGM readings for insulin delivery adjustment. - Collaboration with SweetSpot for virtual CGM monitoring and enhanced patient care. - Filed CE Mark application for European launch of Eversense 365, on track for second half 2025. - Pipeline updates: Gemini and Freedom development, with Gemini aiming to submit an IDE for a pivotal study by year end. - Medicare reimbursement updated to provide payment for full year of Eversense retroactive to January 1. - Mercy Health Systems executive restructuring paused Eversense with remote patient monitoring work, but progress provides insights for future health system initiatives.

In the first quarter of 2025, net revenue grew 24% to $6.3 million compared to $5 million in the prior year period. U.S. revenue was $4.5 million and revenue outside the U.S. was $1.8 million. Gross profit was $1.5 million, an increase from $0.3 million in the prior year period. Research and development expenses in Q1 2025 were $7.3 million, a decrease of $3.1 million compared to the prior year period. Selling, general and administrative expenses were $7.7 million, a decrease of $0.4 million compared to the prior year period. Net loss was $14.3 million or a $0.02 loss per share in Q1 2025, compared to a net loss of $18.9 million or a $0.03 loss per share in Q1 2024.

• Full year 2025 global net revenue expected to be approximately $34 million to $38 million. - Gross profit margins projected to be between 25% and 30% in 2025, steadily increasing each quarter. - Cash runway extended into mid-2026 based on Q1 proceeds from common stock sale. - Expect revenue to be approximately one-third in the first half and two-thirds in the second half of 2025.

• Mercy Health Systems executive restructuring paused ongoing work with them on Eversense with remote patient monitoring, with no estimate on restart. - Tariff situation could impact gross profit margins, but global supply chain and operational changes aim to mitigate negative impacts.

Q: Congrats on the E 365 launch and guidance despite Mercy pause. Break out U.S. vs OUS trajectory.

A: Early launch metrics positive, OUS component with CE Mark approval on schedule, U.S. launch excitement to propagate outside, and DTC efforts and sales rep performance driving growth.

Q: About DTC channels and target patient populations.

A: Focus on social media (Facebook, TikTok, Instagram, YouTube) for geo-targeting, seeing good success in Medicare population and people on insulin.