10-K: Senseonics Holdings Reports 2024 Results, Highlights Progress with Eversense CGM Systems

Sentiment:

Annual Results 3 March 2025 4:17 PM

📋All filings for Senseonics Holdings, INC

Senseonics Holdings, Inc. files its 10-K report for the year ended December 31, 2024, detailing its financial performance and strategic advancements in the global commercialization of its Eversense CGM systems.

Capital raiseThe company does not expect its existing cash and cash equivalents will be sufficient to fund its operations through the next twelve months and will need to seek additional capital to fund its operations, working capital needs, capital expenditures and other strategic initiatives beyond that time.There can be no assurance that we will be successful in raising additional capital or that any needed financing will be available in the future at terms acceptable to us.

Worse than expectedThe company's net loss increased from $60.4 million in 2023 to $78.6 million in 2024.Gross profit decreased from $3.1 million in 2023 to $0.5 million in 2024.The company has identified substantial doubt about its ability to continue as a going concern.

Summary

Senseonics Holdings, Inc. reported its 10-K filing for the fiscal year ended December 31, 2024.
The company is focused on developing and manufacturing glucose monitoring products, including the Eversense E3 and Eversense 365 CGM systems.
In September 2024, the FDA approved the Eversense 365 CGM system for marketing and sale in the U.S., and Ascensia began commercializing it in October 2024.
Ascensia has the exclusive right to distribute the company's Eversense system worldwide.
The company experienced higher direct-to-consumer leads and patient shipments following the launch of Eversense 365.
First-in-human testing for the next-generation Gemini system began in July 2024, with an IDE submission anticipated in the second half of 2025.
Eon Care Services, LLC and Eon Management Services, LLC were formed as wholly-owned subsidiaries to support patient access to the Eversense system.
The company acquired the sensor insertion network assets of NPG to expand patient access and convenience.
The company had 117 full-time employees as of December 31, 2024.
The company incurred a net loss of $78.6 million for the year ended December 31, 2024, compared to a net loss of $60.4 million in 2023.
Total revenue increased slightly to $22.5 million in 2024 from $22.4 million in 2023.
The company's gross profit decreased to $0.5 million in 2024 from $3.1 million in 2023, primarily due to one-time charges related to the transition from Eversense E3 to Eversense 365.
Research and development expenses decreased to $41.1 million in 2024 from $48.8 million in 2023.
Selling, general, and administrative expenses increased to $34.2 million in 2024 from $29.9 million in 2023.
The company has identified substantial doubt about its ability to continue as a going concern.

Sentiment

Score: 4

Explanation: The document presents a mixed picture. While there are positive developments such as FDA approval and increased patient shipments, the significant net loss and concerns about the company's ability to continue as a going concern weigh heavily on the overall sentiment.

Positives

FDA approval and commercialization of Eversense 365.
Increased patient shipments and prescriber interest following the launch of Eversense 365.
Expansion of Medicare coverage for Eversense E3.
Acquisition of NPG's sensor insertion network to improve patient access.
Initiation of first-in-human testing for the Gemini system.

Negatives

The company incurred a net loss of $78.6 million for the year ended December 31, 2024.
Gross profit decreased due to one-time charges related to the transition from Eversense E3 to Eversense 365.
The company has identified substantial doubt about its ability to continue as a going concern.

Risks

The company has incurred significant operating losses since inception and cannot assure profitability.
The company's future revenue depends on the Commercialization Agreement with Ascensia, and Ascensia's failure to perform satisfactorily could adversely affect financial results.
The markets in which the company participates are highly competitive.
The company has limited operating history as a commercial-stage company.
The company's operating results are subject to significant fluctuations.
There is uncertainty regarding the company's ability to maintain liquidity sufficient to operate its business effectively, which raises substantial doubt about its ability to continue as a going concern.
The company contracts with third parties for the manufacture of Eversense, and risks associated with manufacturing could reduce gross margins.
The company operates in a regulated industry, and failure to comply with applicable laws and regulations could harm its business.
Failure or perceived failure to comply with existing or future laws related to data privacy and security could harm the business.
Holders of debt instruments may exert substantial influence over the company.

Future Outlook

The company plans to continue expanding the commercialization of Eversense, developing future products, and obtaining regulatory approvals. The company expects to launch Eversense 365 with Ascensia in the second half of 2025, pending CE Mark approval.

Industry Context

The CGM market is developing and competitive, with key players including Dexcom, Medtronic, and Abbott. The company faces competition from both CGM providers and providers of SMBG systems. The company anticipates increasing competition from companies that integrate CGM with insulin pumps.

Comparison to Industry Standards

Dexcom and Abbott's CGM systems have factory calibration and do not require user calibration, a feature not currently available on Senseonics' products.
Dexcom has received the first FDA iCGM indication, allowing its Dexcom G6 and G7 to be interoperable with other diabetes tech devices such as insulin pumps, while Senseonics received iCGM designation in April 2024.
Roche Diabetes Care, Abbott, and Ascensia account for a substantial share of the worldwide sales of SMBG systems, indicating a competitive landscape for glucose monitoring.

Legal Proceedings

The company is involved in a legal proceeding with Cellspin Soft, Inc. alleging patent infringement, which is currently stayed pending resolution of Inter Partes Review proceedings at the U.S. Patent and Trademark Office.

Related Party Transactions

The company has a distribution arrangement with Ascensia, a related party, which accounted for 82% of total net revenues in 2024.
The company has a financing agreement with PHC Holdings Corporation, the parent company of Ascensia.

Stakeholder Impact

Shareholders face risks due to the company's financial losses and uncertainty about its ability to continue as a going concern.
Employees may be affected by potential cost reduction plans and workforce reorganization.
Patients may benefit from the development and commercialization of new and improved CGM systems.
Suppliers and creditors may be impacted by the company's financial condition and ability to meet its obligations.

Next Steps

Continue commercialization of Eversense 365.
Pursue CE Mark approval for Eversense 365 in Europe.
Advance development of the Gemini system and submit an IDE in the second half of 2025.
Seek additional funding to sustain future operations.

Key Dates

Date	Description
June 26, 2014	Senseonics was originally incorporated as ASN Technologies, Inc. in Nevada.
September 2017	Senseonics affixed the CE mark to the Eversense XL CGM system.
June 21, 2018	Senseonics received PMA approval from the FDA for the 90-day Eversense system.
June 2019	Senseonics received FDA approval for the non-adjunctive indication for the 90-day Eversense system.
August 9, 2020	Senseonics entered into a Commercialization Agreement with Ascensia.
September 30, 2020	PMA supplement to extend the wearable life of the Eversense CGM System to six months was submitted to the FDA.
February 26, 2020	FDA approved a subgroup of PROMISE trial participants to continue for a total of 365 days.
February 2022	The Eversense E3 CGM system was approved by the FDA.
March 2022	Enrollment began for the U.S. 365-day pivotal trial.
June 2022	Senseonics affixed the CE mark to the Eversense E3 CGM system.
September 17, 2024	FDA approved the 510(k) submission for a new product with a 365-day duration and once per week calibration.
September 2024	The FDA approved the Eversense 365 CGM system for marketing and sale in the U.S.
October 2024	Ascensia began commercializing Eversense 365 in the U.S.
February 2025	Data supported the Eversense 365-day product CE Mark submission in compliance with the EU Medical Device Regulation (MDR).

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