DEFA14A: Senseonics Reports Strong Early Launch for Eversense 365 CGM System

Senseonics announced strong early launch indicators for its Eversense 365 CGM system, including record new patient shipments and increased prescriber engagement.

Summary

• Senseonics has provided an update on the commercial launch of its Eversense 365 continuous glucose monitoring (CGM) system.
• The launch began in October with global commercial partner Ascensia Diabetes Care, and product shipments started in November.
• Early indicators show strong interest, with direct-to-consumer leads more than doubling compared to pre-launch months.
• New patient shipments in November were the highest since the Ascensia partnership began.
• The number of providers prescribing Eversense has increased by 42% since the launch, and prescriptions from top prescribers have increased by 69%.
• One-third of Eversense 365 prescribers are new to the product.
• The number of patients switching from competitive CGMs to Eversense has increased by 47% since the launch.
• Senseonics is on track to achieve approximately 50% annual growth in its patient installed base by the end of 2024 compared to 2023.
• The company has reiterated its full-year 2024 global net revenue guidance of approximately $22 million.
• Senseonics is seeking a reverse stock split in January 2025, pending shareholder approval, to attract institutional investors.

Sentiment

Score: 8

Explanation: The document conveys a positive sentiment due to the strong early launch performance of Eversense 365 and the company's growth prospects. The proposed reverse stock split is a strategic move to attract institutional investors, further boosting confidence.

Positives

• The Eversense 365 launch has shown strong early performance indicators.
• There is a significant increase in direct-to-consumer leads.
• New patient shipments have reached a record high.
• The number of prescribing providers and prescriptions from top prescribers have increased substantially.
• There is a notable increase in patients switching from competitor products.
• The company is on track to meet its annual growth target for patient installed base.
• The product is being well received by patients and providers due to its ease of use and data consistency.

Risks

• The success of the Eversense 365 launch depends on the commercialization efforts of Ascensia.
• There are uncertainties in prescriber and patient decisions regarding new technology.
• The company faces risks related to insurer, regulatory, and administrative processes.
• There are uncertainties in the development of and competition in the overall CGM market.
• The proposed reverse stock split may not be approved by shareholders.
• The reverse stock split may not attract institutional investors or improve trading liquidity.

Future Outlook

Senseonics expects heightened interest in Eversense 365 to drive results for 2025 and intends to provide updates on the ongoing launch, product portfolio development, pump-connectivity, additional health care systems, and ex-US commercial launch of Eversense 365 over the course of 2025.

Management Comments

• Brian Hansen, President of Ascensias CGM division, stated that Eversense 365 fully addresses patient needs for a long-term CGM with minimal data disruptions and complete flexibility.
• Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics, said that 2024 has been a landmark year for Senseonics, achieving the long-term goal of commercializing the Eversense 365 product.
• Dr. Goodnow also mentioned that the company is seeking a reverse stock split to overcome limitations for institutional investors.

Industry Context

This announcement highlights the growing demand for long-term, implantable CGM systems in the diabetes management market. The strong early launch of Eversense 365 positions Senseonics as a key player in this space, competing with other CGM manufacturers.

Comparison to Industry Standards

• The 47% increase in patients switching from competitive CGMs suggests a strong market acceptance of Eversense 365, potentially outperforming some competitors in the early launch phase.
• The 42% increase in prescribing providers and 69% increase in prescriptions from top prescribers indicates a strong adoption rate among healthcare professionals, which is a key factor for long-term success.
• The company's target of 50% annual growth in patient installed base is ambitious and, if achieved, would place them among the fastest-growing companies in the CGM market.
• While specific competitor data is not provided, the metrics suggest that Senseonics is gaining market share and is competitive with established players like Dexcom and Abbott.

Stakeholder Impact

• Shareholders may see increased value if the reverse stock split attracts institutional investors.
• Patients will benefit from the availability of the Eversense 365 CGM system.
• Healthcare providers will have a new tool for managing their patients' diabetes.
• Employees may benefit from the company's growth and success.

Next Steps

• Senseonics intends to provide updates on the ongoing 365 launch.
• The company will also provide updates on product portfolio development, pump-connectivity, additional health care systems, and the ex-US commercial launch of Eversense 365 over the course of 2025.
• The company will seek shareholder approval for a reverse stock split in January 2025.

Key Dates

Keywords

Eversense 365, Continuous Glucose Monitoring, CGM, Senseonics, Ascensia Diabetes Care, Diabetes, Medical Technology, Implantable Sensor, Reverse Stock Split