Senseonics Holdings, Inc. Announces Business Updates
Senseonics Holdings, Inc. (SENS) announces operational and financial business updates, including preliminary unaudited fourth quarter revenue of $8.0 million and full year 2023 total revenue of $22.0 million. The company completed data analysis of ENHANCE trial and plans to submit an application for regulatory approval to the FDA for a 365-day once per week calibration product by the end of the first quarter of 2024. The company also closed an additional $10.0 million draw on the loan facility with Hercules Capital, Inc. in the fourth quarter, with unaudited balance of cash, cash equivalents, and marketable securities as of December 31, 2023, expected to be approximately $109.8 million. The company expects to provide financial guidance for 2024 with the full fiscal year 2023 financial results.
Positive
Preliminary unaudited fourth quarter revenue of $8.0 million and full year 2023 total revenue of $22.0 million
Completed data analysis of ENHANCE trial and plans to submit an application for regulatory approval to the FDA for a 365-day once per week calibration product by the end of the first quarter of 2024
Closed an additional $10.0 million draw on the loan facility with Hercules Capital, Inc. in the fourth quarter
Unaudited balance of cash, cash equivalents, and marketable securities as of December 31, 2023, expected to be approximately $109.8 million
With Senseonics Holdings, Inc. reporting preliminary unaudited revenues of approximately $8.0 million for Q4 2023 and $22.0 million for the full year, there is a clear quantitative measure of the company's performance. The company's cash reserves, expected to be around $109.8 million, provide a cushion that may support further R&D and marketing efforts. However, the additional $10.0 million loan signifies an increase in debt, which could impact future profitability. Investors should consider the balance between the company's growth prospects, particularly with the upcoming FDA submission for the 365-day CGM system, against the financial leverage and its implications on financial health.
The advancement to a next-generation sensor platform and the plan for FDA submission are significant for Senseonics' strategic direction. The potential to offer a 365-day, once a week calibration product could be a game-changer in the CGM market, potentially improving patient compliance and satisfaction. The success of clinical trials and the FDA's response will be critical. Stakeholders should monitor the regulatory progress closely, as this will have a direct impact on the company's ability to capture market share and drive long-term growth. The mention of Gemini and Freedom systems suggests an ongoing commitment to innovation, which is crucial in the competitive med-tech landscape.
The emphasis on lead generation and conversion rates indicates a strategic pivot towards aggressive marketing and sales tactics. The partnership with Ascensia Diabetes Care and its role in enhancing commercial infrastructure could be instrumental in scaling up the adoption of Eversense. The company's growth outlook for 2024 will depend on the effectiveness of these initiatives. The market for CGM systems is expanding and Senseonics' ability to differentiate and capture demand, especially with new product innovations, will be key to their success. Investors should watch for the actual conversion of generated leads into sales, as this will be a strong indicator of the company's market penetration and operational efficiency.
01/02/2024 - 04:05 PM
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 $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
“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 $22.0 million $109.8 million
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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Investor Contact
Investors@senseonics.com
Source: Senseonics Holdings, Inc.
What were Senseonics Holdings, Inc.'s preliminary unaudited fourth quarter revenue and full year 2023 total revenue?
Senseonics Holdings, Inc. reported preliminary unaudited fourth quarter revenue of $8.0 million and full year 2023 total revenue of $22.0 million.
What did Senseonics Holdings, Inc. complete and plan to submit an application for regulatory approval to the FDA for?
Senseonics Holdings, Inc. completed data analysis of ENHANCE trial and plans to submit an application for regulatory approval to the FDA for a 365-day once per week calibration product by the end of the first quarter of 2024.
What financial transaction did Senseonics Holdings, Inc. close in the fourth quarter?
Senseonics Holdings, Inc. closed an additional $10.0 million draw on the loan facility with Hercules Capital, Inc. in the fourth quarter.
What is the unaudited balance of cash, cash equivalents, and marketable securities as of December 31, 2023, expected to be?
The unaudited balance of cash, cash equivalents, and marketable securities as of December 31, 2023, is expected to be approximately $109.8 million.
What does Senseonics Holdings, Inc. plan to provide with the full fiscal year 2023 financial results?
Senseonics Holdings, Inc. plans to provide financial guidance for 2024 with the full fiscal year 2023 financial results.
