Senseonics Holdings, Inc. Reports Fourth Quarter and Full Year 2024 Financial Results

Received FDA approval for Eversense$(R)$ 365 Continuous Glucose Monitoring system and launched Eversense 365 with commercial partner, Ascensia

Patient base increased 56% in 2024 over 2023 to approximately 6,000 global patients

GERMANTOWN, Md., March 03, 2025 (GLOBE NEWSWIRE) -- 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 reported financial results for the fourth quarter ended December 31, 2024.

Recent Highlights & Accomplishments:

   -- Eversense(R) 365 approved and launched in the U.S. during 2024 as an 
      integrated continuous glucose monitoring (iCGM) system for people with 
      Type 1 and Type 2 diabetes 
 
   -- Patient base increased 56% in 2024 over 2023 to approximately 6,000 
      global patients 
 
   -- Early indicators of U.S. Eversense 365 launch performance were favorable: 
 
          -- New patient shipments of approximately 600 in December were the 
             highest monthly total in company history 
 
          -- Exceeded 2,400 annual U.S. Eversense prescribers during 2024 with 
             the majority being new prescribers 
 
          -- 81% of our patients have switched to Eversense from competitive 
             CGM's 
 
   -- Completed submission of CE Mark application in Q1 2025 for Eversense 365 
      in European Union 
 
   -- Initiated collaboration with Mercy Health as case study on Eversense and 
      remote patient monitoring use with other cost-conscious health systems 
 
   -- Generated revenue of $8.3 million in the fourth quarter of 2024 and 
      revenue of $22.5 million in the full year 2024 
 
   -- Executed a restructuring process with a target cash operating expense 
      reduction of $10M in 2025 
 
   -- Raised gross proceeds of more than $20 million in 2024 and additional 
      gross proceeds of approximately $27.0 million in early 2025 from equity 
      offerings to strengthen the balance sheet 

"We took a giant step forward in diabetes care in 2024, delivering on our promise of One Year, One CGM, with the Eversense 365 CGM system. The feedback we have received from patients and providers has been very positive, and we are just getting started. We see our 365 day product as the catalyst for revenue growth, as well as for the future of blood glucose monitoring," said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. "Eversense 365 is the foundational base for the next generation Gemini and Freedom systems, and we are progressing in our plans to add automated insulin delivery with pump connectivity to Eversense 365."

Brian Hansen, President of CGM at Ascensia Diabetes Care and a Director of Senseonics, remarked, "Since joining Ascensia's CGM division a year ago, I've watched Senseonics deliver on its promises to patients. Although we are still in the early months of the U.S. launch, key commercial metrics have been positive, which we believe indicates good demand for Eversense in the marketplace. We're looking forward to launching in the EU and bringing this revolutionary CGM option to more patients with diabetes."

Fourth Quarter 2024 Results:

Total revenue for the fourth quarter of 2024 was $8.3 million compared to $8.0 million for the fourth quarter of 2023. U.S. revenue was $6.2 million for both the fourth quarter of 2024 and 2023, and revenue outside the U.S. was $2.1 million in the fourth quarter of 2024 compared to $1.8 million in the prior year period.

Fourth quarter 2024 gross profit of $4.0 million compared to gross profit of $1.1 million for the fourth quarter of 2023. The increase in gross profit was primarily driven by increased margins on the 365-day product, but does include the impact of approximately $1.6 million in manufacturing costs previously expensed to research and development expenses prior to FDA approval of the 365-day product.

Fourth quarter 2024 selling, general and administrative expenses increased by $1.5 million year-over-year, to $8.9 million. The increase was primarily driven by personnel costs, consulting fees and legal expenses.

Fourth quarter 2024 research and development expenses decreased by $1.4 million year-over-year, to $9.4 million. The decrease was primarily due to a reduction in clinical studies spend and consultant costs due to the completion of 365-day product trials.

Net loss was $15.5 million, or a $0.02 loss per share, in the fourth quarter of 2024 compared to net loss of $17.2 million, or a $0.03 loss per share, in the fourth quarter of 2023. Net loss decreased by $1.7 million primarily due to improved gross profit margins of Eversense 365.

Full Year 2024 Results:

Total revenue for 2024 was $22.5 million compared to $22.4 million in 2023. U.S. revenue was $15.3 million in 2024 compared to $14.1 million in 2023, and revenue outside the U.S. was $7.2 million in 2024 compared to $8.3 million in 2023.

Gross profit for 2024 was $0.5 million, a decrease from $3.1 million in 2023. The decrease in gross profit was primarily driven by $4.8 million in one-time charges as the result of the transition from Eversense E3 to Eversense 365, partially offset by an estimated reduction of $1.6 million in pre-approval manufacturing costs previously expensed to research and development expenses.

Selling, general and administrative expenses for 2024 increased by $4.3 million year-over-year, to $34.2 million. The increase was primarily driven by personnel costs, consulting fees and legal expenses.

Research and development expenses for 2024 decreased by $7.6 million year-over-year, to $41.1 million. The decrease was primarily due to a reduction in clinical studies spend and other research costs due to the completion of 365-day product trials. These savings were partially offset by pre-approval inventory costs associated with the manufacturing of the 365-day product.

Net loss was $78.6 million, or a $0.12 loss per share, in 2024 compared to net loss of $60.4 million, or a $0.11 loss per share, in 2023. Net loss increased by $18.2 million primarily due to a reduction in gains due to the exchange of outstanding convertible notes and gains driven by changes in the fair value of derivatives.

Cash, cash equivalents and restricted cash were $74.9 million and outstanding indebtedness was $56.2 million as of December 31, 2024. Subsequent to the end of the fourth quarter, the remaining outstanding 2025 Convertible Notes in the aggregate principal amount of $20.4 million were repaid, reducing the principal debt outstanding to $35 million. Additionally, after year-end, Senseonics has received gross proceeds of approximately $27.0 million from the sale of common stock utilizing its at-the-market facility.

Full Year 2025 Financial Outlook

Senseonics expects full-year 2025 global net revenue to be approximately $34-38 million as we continue to roll out Eversense 365 to U.S. patients. The full-year 2025 financial outlook assumes approximately doubling the global patient base. The financial outlook takes into consideration the following factors: (i) refined visibility of the timeline and specifications for the regulatory approval and the plans for commercial transition to Eversense 365 outside the United States, (ii) plans with respect to spending on the DTC marketing campaign to generate leads, (iii) the status of other sales and marketing initiatives, (iv) utilization of the patient assistance programs for Eversense 365, and (v) transition of reimbursement from Eversense E3 to Eversense 365. Gross margins are expected to increase throughout 2025, with 2025 gross margins between 25 -- 30% for the year. Cash utilization in 2025 is expected to be between $50-$60 million.

Conference Call and Webcast Information:

Company management will host a conference call at 4:30 pm (Eastern Time) today, March 3, 2025, to discuss these financial results and recent business developments. Investors interested in listening to the conference call may do so by accessing a live and archived webcast of the event at this link. Individuals interested in participating in the call via telephone may access the call by dialing +1-800-445-7795 (+1-785-424-1699 for those outside the U.S. or Canada) and referencing Conference ID SENSQ4. A replay of the call can be accessed on Senseonics' website http://www.senseonics.com under "Investor Relations."

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(R) 365 and Eversense(R) 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.

About Eversense

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