Senseonics(US:SENS)2025-11-05 21:20Product Development and Approval - The Eversense E3 system, approved by the FDA in February 2022, offers a 180-day continuous glucose monitoring (CGM) solution, while the Eversense 365 system, approved in September 2024, extends this duration to 365 days[123][139]. - The mean absolute relative difference (MARD) for the Eversense 90 system was reported at 8.5% during a pivotal clinical trial, demonstrating its accuracy over a 90-day period[129]. - The ENHANCE pivotal study for Eversense 365 completed enrollment in the third quarter of 2023, supporting its FDA 510(k) submission approved on September 17, 2024[137][139]. - The FDA approved the Eversense E3 system with proprietary technology that doubles sensor life to six months, maintaining a MARD of 8.5%[136]. - The company began first-in-human testing for the Gemini product in July 2024, which is expected to enhance its product offerings for diabetes management[142]. - Eversense 365 was submitted for CE Mark approval in February 2025, with plans to launch in European markets in the first half of 2026 upon approval[145]. Market Access and Coverage - Approximately 300 million covered lives in the United States have access to Eversense systems due to positive insurance payor coverage decisions, including coverage from UnitedHealthcare effective July 1, 2023[126]. - Medicare coverage for Eversense E3 was expanded in February 2024 to include all insulin users and non-insulin users with a history of problematic hypoglycemia, increasing access for millions of Medicare patients[126]. - The company has entered into strategic partnerships and distribution agreements to promote Eversense systems, including a 2-in-1 glucose monitoring system called "Gemini" and a Bluetooth-enabled product variation[128]. - Eon Care Services, LLC and Eon Management Services, LLC were established to enhance patient access to Eversense systems, with an increase in insertions noted during the second and third quarters of 2025[140]. Financial Performance - Total revenue increased to $8.1 million for the three months ended September 30, 2025, compared to $4.3 million for the same period in 2024, representing a growth of 88.7%[160]. - Revenue from sales to Ascensia accounted for 48% of total revenue for the three months ended September 30, 2025, down from 78% in the same period of 2024[152]. - Revenue from consignment arrangements accounted for 46.5% of total revenue for the three months ended September 30, 2025, compared to 20.1% for the same period in 2024[153]. - Gross profit increased to $3.5 million for the three months ended September 30, 2025, with a gross margin of 42.8%, compared to a gross loss of $4.1 million and a margin of (95.0%) in the same period of 2024[161]. - Total revenue increased to $21.0 million for the nine months ended September 30, 2025, compared to $14.2 million for the same period in 2024, an increase of $6.8 million[167]. - Gross profit increased to $8.1 million for the nine months ended September 30, 2025, compared to a loss of $3.4 million for the same period in 2024, resulting in a gross margin of 38.5%[168]. Expenses and Losses - Research and development expenses decreased to $7.8 million for the three months ended September 30, 2025, down from $10.5 million in the same period of 2024, a reduction of 25.7%[162]. - Selling, general and administrative expenses rose to $15.3 million for the three months ended September 30, 2025, compared to $8.3 million in the same period of 2024, an increase of 84.3%[163]. - Research and development expenses decreased to $22.8 million for the nine months ended September 30, 2025, down from $31.8 million in 2024, a reduction of $9.0 million[169]. - Selling, general and administrative expenses increased to $32.7 million for the nine months ended September 30, 2025, compared to $25.4 million in 2024, an increase of $7.3 million[170]. - The company incurred a net loss of $48.3 million for the nine months ended September 30, 2025, compared to a net loss of $63.1 million in 2024, an improvement of $14.8 million[166]. Cash Flow and Financing - Net cash used in operating activities was $41.2 million for the nine months ended September 30, 2025, compared to $46.2 million for the same period in 2024, reflecting a decrease of 6.5%[186][187]. - Net cash used in investing activities increased significantly to $76.1 million for the nine months ended September 30, 2025, from $14.8 million in 2024[188][189]. - Net cash provided by financing activities was $77.1 million for the nine months ended September 30, 2025, a substantial increase from $12.8 million in 2024[190][191]. - The company entered into an at-the-market sales agreement with TD Securities for the sale of up to $100.0 million in common stock[173]. - The company completed a public offering of 5,000,000 shares at a price of $10.00 per share, raising gross proceeds of $57.5 million[176]. - The company had $72.3 million in net proceeds from a public offering and private placement during the nine months ended September 30, 2025[190]. Going Concern and Future Outlook - The company has determined that substantial doubt exists regarding its ability to continue as a going concern for the one-year period following the issuance of the financial statements[183]. - There is no assurance that the company will be successful in obtaining sufficient funding on acceptable terms, which could adversely affect its business prospects[183]. - The company plans to finance its cash needs through public or private debt and equity financings, collaborations, strategic alliances, and licensing arrangements[183]. - The company is negotiating the transfer of commercial operations related to Eversense from Ascensia back to itself, which may enhance revenue generation and market adoption[182].