Senseonics Holdings, Inc. Provides Business Update and Full Year 2024 Financial Outlook

Rhea-AI Summary

Senseonics Holdings, a medical tech company specializing in long-term, implantable continuous glucose monitoring (CGM) systems, has released its business updates and financial outlook for 2024. The first half of 2024 saw a 21% increase in net revenue to $10 million and over a 200% rise in new patient starts in the U.S. compared to the same period in 2023. The FDA review of the new 365-day Eversense system is on track for a Q4 2024 launch. Collaborations with Mercy Health are progressing with provider training and patient identification underway.

For the full year 2024, Senseonics expects global net revenue between $22 million and $24 million, with significant growth in U.S. patient starts and a 50% increase in the global installed base. However, inventory dynamics may affect Q3 sales, with an anticipated acceleration in Q4. Cash utilization is projected to remain stable at around $70 million.

Positive

• 21% increase in net revenue for the first half of 2024, reaching $10 million.
• Over 200% increase in new patient starts in the U.S. for the first half of 2024.
• FDA review for the 365-day Eversense system is progressing as planned.
• Full year 2024 global net revenue forecasted between $22 million and $24 million.
• Expected 50% increase in global installed base in 2024.

Negative

• Inventory dynamics may impact Q3 2024 sales.
• Cash utilization expected to remain high at $70 million in 2024.

Senseonics Holdings’ full-year 2024 financial outlook presents notable growth projections. With expected global net revenue between $22 million and $24 million, the company envisions a strong market presence driven by the increased adoption of its continuous glucose monitoring (CGM) systems. The predicted doubling of U.S. new patient starts and a 50% increase in the global installed base highlight aggressive growth strategies. However, investors should also note the consistent cash utilization at approximately $70 million, which could indicate ongoing high operational costs. The anticipated acceleration in sales in Q4, following the 365-day product launch, could be a turning point for revenue streams. Potential risks include inventory dynamics and market acceptance of the new product, which could affect revenue stability in the short term.

Rating: 1

The FDA review of Senseonics’ 510(k) submission for the 365-day, once-a-week calibration Eversense system is a significant milestone. If approved, this next-generation CGM system could offer improved convenience and compliance for diabetes patients, potentially increasing market penetration. The collaboration with Mercy Health to train providers and identify patients suggests a robust support system aimed at enhancing user adoption. Investors should be aware that FDA approval timelines can be unpredictable, which might affect the planned launch and subsequent revenue. Additionally, the long-term success will depend on the system's clinical performance and user feedback post-launch.

Rating: 1

The business updates indicate Senseonics is targeting a substantial market expansion by leveraging strategic collaborations and product innovation. The 200% increase in new patient starts within the U.S. signals growing product awareness and market acceptance. The collaboration with a large health system like Mercy Health could provide a scalable model for broader deployment. Key considerations for investors include the competitive landscape of the CGM market, which features established players like Dexcom and Abbott. Senseonics must differentiate its offerings significantly to capture market share. The anticipated growth hinges on successful execution of these strategic initiatives and competitive positioning.

Rating: 1

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 business updates and provided its full year 2024 financial outlook.

Business Updates

• Reaffirmed global net revenue for the first half of 2024 is expected to be $10 million, representing growth of approximately 21% compared to the first half of 2023
• Generated over 200% more new patient starts in the US in the first half of 2024 compared to the first half of 2023
• FDA review of the 510(k) submission for the next-generation 365-day, once a week calibration, Eversense® system currently advancing as planned to enable a fourth quarter 2024 launch
• Initiated provider training and patient identification with Mercy Health as part of the collaboration, ahead of targeted first insertions in the third quarter of 2024 and planned acceleration in the fourth quarter of 2024

“We have been executing our business plan in the first half of 2024. Key milestones to support adoption of Eversense include increasing new patient starts, receiving the iCGM designation, submitting a 510(k) to the FDA for the 365-day Eversense system, and launching our collaboration with Mercy Health,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “The Eversense platform now sits in its strongest position of all time. We are working diligently to convert two significant growth opportunities—the anticipated launch of our 365-day product together with the new leadership at Ascensia Diabetes Care and the Mercy collaboration. We believe the prospect of delivering a CGM system to patients that can last for one year, with just one calibration per week, and the potential to make Eversense CGM + RPM a systemic solution with a health system the scale of Mercy both present the opportunity to enable transformative growth for Senseonics.”

Full Year 2024 Financial Outlook

Senseonics expects full year 2024 global net revenue to be in the range of $22 million to $24 million. The full year 2024 financial outlook assumes more than doubling the U.S. new patient starts and increasing the global installed base by approximately 50% in 2024 compared to 2023. Inventory dynamics associated with the 365-day product launch are expected to impact third quarter product sales, with sales expected to accelerate in the fourth quarter based on 365-day product sales and the Mercy collaboration. Cash utilization in 2024 is expected to be consistent with 2023 at approximately seventy million dollars.

Business Update and Analyst Event Webcast Information:

Company management will host a business update and analyst event at 10:00 am (Eastern Time) on Sunday, June 23, 2024. Interested parties may access a live and recorded webcast of the presentation on the “Investor Relations” section of the company’s website at www.senseonics.com.

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 system Eversense® E3 includes 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 revenue and patient start projections and sales expectations under “Full Year 2024 Financial Outlook”, statements regarding the integration of the Eversense CGM and the Eversense RPM solution within the Mercy health care system and the potential impact of the program, the adoption and growth of Eversense, statements regarding expected regulatory approvals and timing of the potential commercial launch of the 365-day product, and other statements containing the words "believe," “expect,” “anticipate,” “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: uncertainties inherent in the execution of the independent business unit of Ascensia Diabetes Care, the Company’s commercialization partner for Eversense, and other commercial initiatives, uncertainties in insurer, regulatory and administrative processes and decisions, uncertainties inherent in the development and registration of new technology and solutions, uncertainties inherent in finalizing integration and commercial terms with new partners and other third parties, uncertainties inherent in the ongoing commercialization of the Eversense product and the expansion of the Eversense product and a new RPM solution, uncertainties relating to the current economic environment and such other factors as are set forth in the risk factors detailed in Senseonics' Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, the Annual Report on Form 10-K for the year ended December 31, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240621700133/en/

Senseonics Investor Contact

Philip Taylor

Gilmartin Group

415-937-5406

Investors@senseonics.com

Source: Senseonics Holdings, Inc.

FAQ

What is the financial outlook of Senseonics Holdings for 2024?

Senseonics expects global net revenue between $22 million and $24 million for the full year 2024.

How did Senseonics perform financially in the first half of 2024?

Senseonics reported a 21% increase in net revenue, totaling $10 million in the first half of 2024.

What is the status of the FDA review for Senseonics' new 365-day Eversense system?

The FDA review for the 365-day Eversense system is progressing as planned, aiming for a Q4 2024 launch.

What growth is expected in new patient starts for Senseonics in 2024?

Senseonics anticipates more than doubling U.S. new patient starts in 2024.

How will inventory dynamics affect Senseonics' sales in 2024?

Inventory dynamics related to the 365-day product launch may impact Q3 sales, but sales are expected to accelerate in Q4 2024.

What is the expected cash utilization for Senseonics in 2024?

Cash utilization for Senseonics is expected to remain consistent with 2023 at approximately $70 million.