Senseonics(SENS) - 2025 Q2 - Quarterly Results

Company Overview and Q2 Highlights Senseonics Holdings, Inc. is a medical technology company focused on long-term implantable CGM systems, achieving significant Q2 growth in US new patient starts and securing substantial funding for product development and market expansion Company Profile Senseonics Holdings, Inc. is a medical technology company focused on developing and manufacturing long-term implantable continuous glucose monitoring (CGM) systems for diabetes patients, with key products including Eversense 365 and Eversense E3 - Senseonics Holdings, Inc. is dedicated to developing and manufacturing long-term implantable continuous glucose monitoring (CGM) systems for diabetes patients[1][11] - The company's CGM systems, Eversense® 365 and Eversense® E3, feature a small, fully implantable subcutaneous sensor that automatically transmits glucose data every 5 minutes to a user's smartphone application via a smart transmitter[11] Recent Highlights & Accomplishments The company focused on the US launch of Eversense 365 in Q2, achieving a 79% year-over-year increase in new patient starts, alongside expanding DTC advertising, transitioning providers to Eon Care, securing CMS Medicare reimbursement for Eversense 365, and signing a commercial development agreement with Sequel Med Tech to integrate AID systems, while also raising $77.8 million through public and private offerings - US new patient starts increased by 79% year-over-year[1][5] - Expanded direct-to-consumer (DTC) advertising campaigns, with the first month of enhanced activity generating 50% more leads than the average of the preceding three months[5] - Completed the transition of service providers to Eon Care, with 38 providers now supporting patient implants[5] - CMS updated the Medicare Physician Fee Schedule, providing a full year of Medicare benefit reimbursement for Eversense 365[5] - Signed a commercial development agreement with Sequel Med Tech to integrate the twiist™ automated insulin delivery (AID) system with Eversense 365, with an anticipated launch in Q4[5] - Raised $57.5 million through a public offering and $20.3 million from an Abbott private placement, totaling $77.8 million in gross proceeds, to support the continued promotion of Eversense 365 and pipeline product development[5] Second Quarter 2025 Financial Performance The company reported a 37% year-over-year revenue increase to $6.6 million in Q2 2025, with significantly improved gross profit and a reduced net loss of $14.5 million due to higher margins and lower R&D expenses Revenue Analysis Total revenue for Q2 2025 increased by 37% year-over-year to $6.6 million, primarily driven by a 79% growth in US new patient starts, with significant US revenue increase offsetting a slight decline in ex-US revenue Q2 2025 Revenue Performance (2025 vs. 2024) | Metric | Q2 2025 (million USD) | Q2 2024 (million USD) | Year-over-Year Change | | :----- | :-------------------- | :-------------------- | :-------------------- | | Total Revenue | $6.6 | $4.9 | +37% | | US Revenue | $4.9 | $3.0 | +63.3% | | Ex-US Revenue | $1.7 | $1.9 | -10.5% | Gross Profit Gross profit for Q2 2025 significantly increased to $3.1 million from $0.3 million in Q2 2024, primarily due to improved 365-day product margins and a one-time benefit from the recovery of previously expensed VAT Q2 2025 Gross Profit (2025 vs. 2024) | Metric | Q2 2025 (million USD) | Q2 2024 (million USD) | Year-over-Year Change | | :----- | :-------------------- | :-------------------- | :-------------------- | | Gross Profit | $3.1 | $0.3 | +933.3% | - The increase in gross profit was primarily driven by improved 365-day product margins and a one-time benefit from the recovery of previously expensed value-added tax (VAT)[5][6] Operating Expenses In Q2 2025, Research and Development expenses decreased year-over-year, while Selling, General and Administrative expenses increased year-over-year Research and Development (R&D) Expenses R&D expenses for Q2 2025 decreased by $3.1 million year-over-year to $7.7 million, primarily due to reduced clinical study expenditures and consulting fees following the completion of the 365-day product trial Q2 2025 Research and Development Expenses (2025 vs. 2024) | Metric | Q2 2025 (million USD) | Q2 2024 (million USD) | Year-over-Year Change | | :----- | :-------------------- | :-------------------- | :-------------------- | | R&D Expenses | $7.7 | $10.8 | -28.6% | - The decrease in R&D expenses was primarily due to reduced clinical study expenditures and consulting fees following the completion of the 365-day product trial[6] Selling, General and Administrative (SG&A) Expenses SG&A expenses for Q2 2025 increased by $0.7 million year-over-year to $9.7 million, primarily due to higher sales commission expenses from increased consignment sales and increased personnel costs supporting the Eon Care implanter network Q2 2025 Selling, General and Administrative Expenses (2025 vs. 2024) | Metric | Q2 2025 (million USD) | Q2 2024 (million USD) | Year-over-Year Change | | :----- | :-------------------- | :-------------------- | :-------------------- | | SG&A Expenses | $9.7 | $9.0 | +7.8% | - The increase in expenses was primarily driven by higher sales commission expenses due to increased consignment sales and increased personnel costs supporting the Eon Care implanter network[7] Net Loss and Earnings Per Share (EPS) Net loss for Q2 2025 decreased by $5.8 million to $14.5 million, resulting in a loss per share of $0.02, an improvement from Q2 2024's net loss of $20.3 million (loss per share of $0.03), primarily due to improved gross margins from US Eversense 365 sales and reduced R&D costs Q2 2025 Net Loss and Loss Per Share (2025 vs. 2024) | Metric | Q2 2025 (million USD) | Q2 2024 (million USD) | Year-over-Year Change | | :----- | :-------------------- | :-------------------- | :-------------------- | | Net Loss | $(14.5) | $(20.3) | -28.57% | | Loss Per Share | $(0.02) | $(0.03) | -33.33% | - The reduction in net loss was primarily attributable to improved gross margins from US Eversense 365 sales and an overall decrease in R&D costs[8] Full Year 2025 Financial Outlook Senseonics projects full-year 2025 global net revenue of approximately $34 million to $38 million, with the global patient base expected to double, revenue generation weighted towards the second half, particularly Q4, due to Eversense 365 annual reorder dynamics, and full-year gross margin anticipated to improve to 32.5% to 37.5%, with operating cash usage around $60 million Full Year 2025 Financial Outlook | Metric | Outlook | | :----- | :------ | | Global Net Revenue | ~$34-38 million USD | | Global Patient Base | Approximately double | | Revenue Distribution | ~1/3 H1, ~2/3 H2 (Q4 weighted higher) | | Gross Margin | 32.5% - 37.5% | | Operating Cash Usage | ~$60 million USD | - The financial outlook considers the timing and specifications of Eversense 365 regulatory approvals and commercial transitions outside the US, DTC marketing expenditure plans, other sales and marketing initiatives, the utilization and impact of patient assistance programs, and the ongoing progress of the Eversense E3 to Eversense 365 reimbursement transition[9] Product and Partner Information The company's Eversense CGM systems offer long-term glucose monitoring for diabetes patients, supported by strategic partnerships with Ascensia Diabetes Care and its parent company, PHC Holdings Corporation, for global distribution and healthcare solutions About Eversense Continuous Glucose Monitoring (CGM) Systems Eversense CGM systems (Eversense 365 and E3) are designed for diabetes patients aged 18 and older, offering continuous glucose monitoring for up to 365 and 180 days, respectively, serving as a replacement for fingerstick measurements in diabetes treatment decisions, though calibration is still required, with sensor insertion and removal performed by healthcare providers as prescription devices - Eversense® 365 and Eversense® E3 CGM systems are indicated for diabetes patients aged 18 and older, providing continuous glucose measurements for up to 365 and 180 days, respectively[12] - These systems can be used to replace fingerstick blood glucose measurements for diabetes treatment decisions, though Eversense 365 requires one fingerstick calibration per week after day 14, and Eversense E3 requires one per day after day 21[12] - Sensor insertion and removal procedures are performed by healthcare providers, and Eversense CGM systems are prescription devices[12] Strategic Partnerships Senseonics maintains a global exclusive distribution partnership with Ascensia Diabetes Care, a subsidiary of PHC Holdings Corporation, collaborating to improve the lives of diabetes patients through innovative solutions Ascensia Diabetes Care Ascensia Diabetes Care is Senseonics' global exclusive distribution partner for Eversense CGM systems, empowering diabetes patients with innovative solutions and owning the CONTOUR® blood glucose monitoring system portfolio, operating in over 100 countries with approximately 1,400 employees - Ascensia Diabetes Care is the global exclusive distribution partner for Senseonics Eversense® continuous glucose monitoring systems[13] - Ascensia also owns the globally recognized CONTOUR® blood glucose monitoring system portfolio, operating in over 100 countries with approximately 1,400 employees[13][14] PHC Holdings Corporation PHC Holdings Corporation is a global healthcare company and the parent of Ascensia Diabetes Care, developing, manufacturing, selling, and servicing solutions in diabetes management, healthcare, life sciences, and diagnostics through its subsidiaries, with 353.9 billion JPY in consolidated net sales for FY2024 and products distributed in over 125 countries - PHC Holdings Corporation is a global healthcare company and the parent company of Ascensia Diabetes Care Holdings AG[15] - The PHC Group reported consolidated net sales of 353.9 billion JPY for fiscal year 2024, with products and services distributed in over 125 countries globally[15] Condensed Consolidated Financial Statements The company's balance sheet as of June 30, 2025, shows increased total assets and stockholders' equity, while the statements of operations reflect improved gross profit and reduced net loss for both the three and six months ended June 30, 2025 Condensed Consolidated Balance Sheets As of June 30, 2025, total assets increased to $150.3 million from $100.4 million at December 31, 2024, driven by higher short-term investments and cash, while total liabilities decreased from $79.3 million to $55.6 million due to reduced short-term notes payable, and stockholders' equity shifted from a $16.6 million deficit to a $94.7 million positive balance Condensed Consolidated Balance Sheets (Selected Items) | Metric (thousand USD) | June 30, 2025 | December 31, 2024 | Change | | :-------------------- | :------------ | :---------------- | :----- | | Cash and Cash Equivalents | $31,518 | $74,597 | $(43,079) | | Short-term Investments, net | $94,894 | — | $94,894 | | Total Current Assets | $141,588 | $91,438 | $50,150 | | Total Assets | $150,274 | $100,438 | $49,836 | | Total Current Liabilities | $14,776 | $38,849 | $(24,073) | | Total Liabilities | $55,554 | $79,337 | $(23,783) | | Total Stockholders' Equity (Deficit) | $94,720 | $(16,555) | $111,275 | Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss For the three months ended June 30, 2025, total revenue was $6.6 million, gross profit was $3.1 million, and net loss was $14.5 million (loss per share of $0.02), while for the six months, total revenue was $12.9 million, gross profit was $4.6 million, and net loss was $28.8 million (loss per share of $0.04), indicating significant improvement in gross profit and reduced net loss compared to the prior year Unaudited Condensed Consolidated Statements of Operations (Selected Items) | Metric (thousand USD) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :-------------------- | :------ | :------ | :------ | :------ | | Total Revenue | $6,649 | $4,865 | $12,906 | $9,912 | | Gross Profit | $3,121 | $298 | $4,626 | $633 | | Operating Loss | $(14,323) | $(19,493) | $(27,811) | $(37,724) | | Net Loss | $(14,501) | $(20,287) | $(28,760) | $(39,164) | | Basic Net Loss Per Share | $(0.02) | $(0.03) | $(0.04) | $(0.06) | Additional Information This section provides details on the Q2 2025 conference call, outlines forward-looking statements subject to various risks, and lists investor contact information Conference Call and Webcast Information Senseonics held a conference call on August 6, 2025, at 4:30 PM ET to discuss financial results and recent business developments, providing webcast and dial-in access - The company held a conference call on August 6, 2025, at 4:30 PM ET to discuss financial results and recent business developments, with investor participation available via webcast or dial-in[10] Forward-Looking Statements The report contains forward-looking statements regarding future expectations, plans, and prospects, particularly concerning revenue, gross margin, cash flow, and global customer base forecasts, as well as product development, which are subject to various significant factors and risks that could cause actual results to differ materially - The press release contains forward-looking statements regarding future expectations, plans, and prospects, including projections for fiscal year 2025 revenue, gross margin, cash flow, and global customer base[16] - Actual results may differ materially from forward-looking statements due to various significant factors, including uncertainties related to reliance on commercialization partners, regulatory processes, new technology development, and economic conditions, with detailed information outlined in reports filed with the SEC[17] Investor Contact Senseonics investor contact information is provided through LifeSci Advisors - Investors can contact Senseonics Investor Relations through Jeremy Feffer at LifeSci Advisors via investors@senseonics.com[18]