Senseonics Holdings, Inc. Announces Business Updates - Jan 02, 2024

GERMANTOWN, Md.--(BUSINESS WIRE)-- 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.

About Senseonics

Senseonics Holdings, Inc. (“Senseonics”) is a medical technology company focused on the development and manufacturing of glucose monitoring products designed to transform lives in the global diabetes community with differentiated, long-term implantable glucose management technology. Senseonics’ CGM systems, Eversense®, Eversense® XL and Eversense® E3 include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user’s smartphone.

Forward Looking Statements

Any statements in this press release about future expectations, plans and prospects for Senseonics, including the Q42023 and full year 2023 revenue expectations, statements regarding PHC Group’s building of it’s dedicated CGM business unit and Ascensia’s other efforts to improvement lead conversion and other performance measures, statements regarding the timelines and expectations with respect to the planned regulatory submission for the next generation product, statements regarding other product development programs and pipeline, statements regarding growth and adoption of Eversense, and other statements containing the words “believe,” “expect,” “intend,” “may,” “projects,” “will,” “planned,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the possibility of adjustments to financial results in connection with the finalization and audit of the Company’s 2023 financial statements, uncertainties inherent in the ongoing commercialization of the Eversense product, uncertainties inherent in PHC Group’s development of a dedicated CGM business, uncertainties inherit in Ascensia’s performance and other commercial initiatives, including the ability to hire, retain and effectively incentivize the dedicated CGM workforce, uncertainties in the regulatory approval process, uncertainties in insurer, regulatory and administrative processes and decisions, uncertainties inherent in the development and registration of new technology, uncertainties relating to the current economic environment and such other factors as are set forth in the risk factors detailed in Senseonics’ Annual Report on Form 10-K for the year ended December 31, 2022, the Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 and Senseonics’ other filings with the SEC under the heading “Risk Factors.” In addition, the forward-looking statements included in this press release represent Senseonics’ views as of the date hereof. Senseonics anticipates that subsequent events and developments will cause Senseonics’ views to change. However, while Senseonics may elect to update these forward-looking statements at some point in the future, Senseonics specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing Senseonics’ views as of any date subsequent to the date hereof.

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