Senseonics Holdings (SENS) Provides Business Update

Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced operational and financial business updates.

Recent Highlights & Accomplishments:

• Generated preliminary unaudited fourth quarter revenue of approximately $8.0 million, and unaudited full year 2023 total revenue of approximately $22.0 million
• Completed data analysis of ENHANCE trial and determined to advance to the next generation sensor platform as the underlying technology used in the 365-day and future products
• Plan to review final data and submit application for regulatory approval to the FDA with target of 365-day once per week calibration product submission by the end of the first quarter of 2024
• PHC Group continues to prioritize building its dedicated CGM organization with additional capabilities and leadership, intended to strengthen focus and performance
• Closed an additional $10.0 million draw on the loan facility with Hercules Capital, Inc. in the fourth quarter, further enhancing liquidity

“Our progress in 2023 represents continued execution across our strategic initiatives to advance both the adoption of Eversense and our product development programs for the world’s first and only long-term CGM. Significant new lead generation from advertising campaign activities in the fourth quarter by our global commercial partner Ascensia Diabetes Care demonstrated strong patient response to the Eversense message. Now Ascensia is working to accelerate and improve the conversion of those leads by enhancing its CGM-dedicated commercial infrastructure,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “As we look ahead to 2024, we expect Ascensia to upgrade lead conversions so they can work down their current inventory received in the fourth quarter to support demand through the upcoming product innovation cycle. We are targeting FDA submission of a 365-day, once a week calibration product and expect this product to drive a positive inflection in healthcare provider adoption and patient demand. We believe that leveraging this next-generation sensor platform, which is also the basis for our planned Gemini and Freedom systems, will provide development advantages in future product development cycles and support the long-term growth and adoption of Eversense.”

2023 Financial Results

The Company currently expects to report revenues of approximately $8.0 million for the fourth quarter 2023 and full year 2023 total revenue of approximately $22.0 million. The Company’s unaudited balance of cash, cash equivalents and marketable securities as of December 31, 2023, is expected to be approximately $109.8 million. The Company expects to report its full fourth quarter and fiscal year 2023 financial results in the ordinary course later this quarter. The preliminary financial results described in this update have not been audited and are subject to adjustment based on the Company’s completion of year-end financial close processes.

Considerations for 2024 Growth Outlook

The Company also plans to provide financial guidance for 2024 with the full fiscal year 2023 financial results. Factors impacting expected positive revenue growth in 2024 include the most current assessments of (i) plans with respect to further spending on the DTC marketing campaign to generate leads, (ii) status of Ascensia’s efforts to strengthen its capacity and capabilities to improve lead conversion, (iii) Ascensia’s progress in working through current, increased inventory levels, (iv) the status of other sales and marketing initiatives, and (v) refined visibility of the timeline and specifications for the regulatory submission of the Company’s next generation longer duration product and the plans for commercial transition to that product.

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