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Senseonics(SENS) - 2025 Q2 - Quarterly Report
2025-08-06 20:02
[PART I: Financial Information](index=2&type=section&id=PART%20I%3A%20Financial%20Information) This section provides the unaudited condensed consolidated financial statements and management's discussion and analysis for Senseonics Holdings, Inc [ITEM 1: Financial Statements](index=3&type=section&id=ITEM%201%3A%20Financial%20Statements) This section presents Senseonics Holdings, Inc.'s unaudited condensed consolidated financial statements and explanatory notes [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This statement provides a snapshot of the company's assets, liabilities, and equity at specific points in time Condensed Consolidated Balance Sheets (in thousands) | Metric | June 30, 2025 (Unaudited) | December 31, 2024 | | :-------------------------------- | :--------------------------------------- | :------------------------------- | | **Assets** | | | | Cash and cash equivalents | $31,518 | $74,597 | | Short term investments, net | $94,894 | — | | Total current assets | $141,588 | $91,438 | | Total assets | $150,274 | $100,438 | | **Liabilities & Equity** | | | | Total current liabilities | $14,776 | $38,849 | | Total liabilities | $55,554 | $79,337 | | Total stockholders' equity (deficit) | $94,720 | $(16,555) | - Total assets increased by approximately **$49.8 million** from December 31, 2024, to June 30, 2025, primarily due to a significant increase in short-term investments[8](index=8&type=chunk) - Total stockholders' equity shifted from a deficit of **$(16.6) million** to a positive **$94.7 million**, indicating a substantial improvement in the company's equity position[8](index=8&type=chunk) [Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This statement details the company's revenues, expenses, and net loss over specific reporting periods Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :-------------------------------------- | :-------------------------------------- | :------------------------------------ | :------------------------------------ | | Total revenue | $6,649 | $4,865 | $12,906 | $9,912 | | Gross profit | $3,121 | $298 | $4,626 | $633 | | Research and development expenses | $7,715 | $10,800 | $15,014 | $21,238 | | Selling, general and administrative expenses | $9,729 | $8,991 | $17,423 | $17,119 | | Operating loss | $(14,323) | $(19,493) | $(27,811) | $(37,724) | | Net Loss | $(14,501) | $(20,287) | $(28,760) | $(39,164) | | Basic net loss per common share | $(0.02) | $(0.03) | $(0.04) | $(0.06) | - Total revenue increased by **$1.78 million** (**36.7%**) for the three months ended June 30, 2025, and by **$2.99 million** (**30.2%**) for the six months ended June 30, 2025, compared to the same periods in 2024[10](index=10&type=chunk) - Gross profit significantly improved, increasing from **$0.3 million** to **$3.1 million** for the three-month period and from **$0.6 million** to **$4.6 million** for the six-month period, driven by higher revenue and lower cost of sales[10](index=10&type=chunk) - Net loss decreased for both periods, from **$(20.3) million** to **$(14.5) million** for the three months and from **$(39.2) million** to **$(28.8) million** for the six months, indicating improved financial performance[10](index=10&type=chunk) [Unaudited Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit)](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity%20(Deficit)) This statement tracks changes in the company's equity components over specific reporting periods Unaudited Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit) (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :----------------------------- | :----------------------------- | | Common Stock (Amount) | $815 | $595 | | Additional Paid-In Capital | $1,070,516 | $930,724 | | Accumulated Deficit | $(976,634) | $(947,874) | | Total Stockholders' Equity (Deficit) | $94,720 | $(16,555) | - The company's total stockholders' equity significantly improved from a deficit of **$(16.6) million** at December 31, 2024, to a positive **$94.7 million** at June 30, 2025, primarily due to the issuance of common stock[12](index=12&type=chunk) - Issuance of common stock, net of issuance costs, contributed **$98.7 million** to additional paid-in capital for the six months ended June 30, 2025[12](index=12&type=chunk) - Conversion of preferred stock added **$37.6 million** to stockholders' equity during the six months ended June 30, 2025[12](index=12&type=chunk) [Unaudited Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This statement summarizes the cash inflows and outflows from operating, investing, and financing activities Unaudited Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :-------------------------------------- | :-------------------------------------- | | Net cash used in operating activities | $(25,347) | $(31,404) | | Net cash used in investing activities | $(94,956) | $(18,150) | | Net cash provided by financing activities | $77,224 | $9,016 | | Net decrease in cash, cash equivalents, and restricted cash | $(43,079) | $(40,538) | | Cash, cash equivalents, and restricted cash at ending of period | $31,833 | $35,171 | - Net cash used in operating activities decreased by **$6.06 million**, from **$(31.4) million** in 2024 to **$(25.3) million** in 2025, reflecting improved operational efficiency[13](index=13&type=chunk) - Net cash provided by financing activities significantly increased to **$77.2 million** in 2025 from **$9.0 million** in 2024, primarily due to proceeds from public and private offerings of common stock[13](index=13&type=chunk) - The company repaid **$20.4 million** of 2025 Notes during the six months ended June 30, 2025[13](index=13&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements [1. Organization and Nature of Operations](index=8&type=section&id=1.%20Organization%20and%20Nature%20of%20Operations) This note describes the company's business, its focus on CGM systems, and recent subsidiary formations - Senseonics Holdings, Inc. is a medical technology company focused on developing and manufacturing long-term, implantable continuous glucose monitoring (CGM) systems for diabetes management[14](index=14&type=chunk) - The company formed Eon Care Services, LLC and Eon Management Services, LLC in April and July 2024, respectively, as wholly-owned subsidiaries to support patient access to Eversense Systems[15](index=15&type=chunk) [2. Liquidity and Capital Resources](index=8&type=section&id=2.%20Liquidity%20and%20Capital%20Resources) This note discusses the company's financial position, historical losses, and recent capital-raising activities - The company has incurred significant net losses since inception, with a net loss of **$28.8 million** for the six months ended June 30, 2025, and an accumulated deficit of **$976.6 million**[16](index=16&type=chunk) - As of June 30, 2025, the company had unrestricted cash, cash equivalents, and marketable securities of **$126.4 million**[16](index=16&type=chunk) - Management believes the company has sufficient resources to meet anticipated operating needs for the next twelve months, alleviating prior going concern doubts, due to recent financing proceeds and existing cash[22](index=22&type=chunk) Recent Financing Activities (May 2025) | Offering Type | Gross Proceeds | Net Proceeds | | :-------------------- | :------------- | :----------- | | Public Offering | $57.5 million | $52.1 million | | Private Placement (Abbott) | $20.3 million | $20.1 million | [3. Summary of Significant Accounting Policies](index=10&type=section&id=3.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines the key accounting principles and methods used in preparing the financial statements - The unaudited consolidated financial statements are prepared in accordance with U.S. GAAP for interim financial information and SEC regulations, with certain information condensed or omitted[23](index=23&type=chunk)[24](index=24&type=chunk) - The company operates and manages its business as one segment: diabetes products and services[25](index=25&type=chunk) - Eon Care PCs are consolidated as Variable Interest Entities (VIEs) because the company is the primary beneficiary, directing significant activities and absorbing potential losses or benefits[27](index=27&type=chunk) - The company is evaluating new FASB ASUs (2023-09 and 2024-03) regarding income tax and expense disaggregation disclosures, expecting no material impact on financial statements from ASU 2023-09[29](index=29&type=chunk)[30](index=30&type=chunk) [4. Revenue Recognition](index=14&type=section&id=4.%20Revenue%20Recognition) This note describes the company's revenue streams, including sales to distributors and consignment arrangements - Revenue is generated from sales of Eversense Systems to Ascensia, third-party distributors, and strategic fulfillment partners, as well as through a consignment model with healthcare professionals[32](index=32&type=chunk) Revenue by Geographic Region (in thousands) | Region | 3 Months Ended June 30, 2025 | % of Total (2025) | 3 Months Ended June 30, 2024 | % of Total (2024) | | :------------------------ | :--------------------------- | :---------------- | :--------------------------- | :---------------- | | United States | $4,946 | 74.4% | $3,030 | 62.3% | | Outside of the United States | $1,703 | 25.6% | $1,835 | 37.7% | | **Total** | **$6,649** | **100.0%** | **$4,865** | **100.0%** | | Region | 6 Months Ended June 30, 2025 | % of Total (2025) | 6 Months Ended June 30, 2024 | % of Total (2024) | | :------------------------ | :--------------------------- | :---------------- | :--------------------------- | :---------------- | | United States | $9,441 | 73.2% | $6,706 | 67.7% | | Outside of the United States | $3,465 | 26.8% | $3,206 | 32.3% | | **Total** | **$12,906** | **100.0%** | **$9,912** | **100.0%** | Revenue Concentration (Sales to Ascensia) | Period | % of Total Revenue | | :-------------------------- | :----------------- | | 3 Months Ended June 30, 2025 | 52% | | 3 Months Ended June 30, 2024 | 84% | | 6 Months Ended June 30, 2025 | 61% | | 6 Months Ended June 30, 2024 | 86% | Consignment Sales as % of Total Revenue | Period | % of Total Revenue | | :-------------------------- | :----------------- | | 3 Months Ended June 30, 2025 | 40.9% | | 3 Months Ended June 30, 2024 | 14.7% | | 6 Months Ended June 30, 2025 | 32.5% | | 6 Months Ended June 30, 2024 | 11.3% | [5. Net Loss per Share](index=16&type=section&id=5.%20Net%20Loss%20per%20Share) This note details the calculation of basic and diluted net loss per common share for the periods presented Net Loss Per Share (in thousands) | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :--------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Net loss | $(14,501) | $(20,287) | $(28,760) | $(39,164) | | Basic and diluted net loss per share | $(0.02) | $(0.03) | $(0.04) | $(0.06) | - Basic and diluted net loss per common share improved from **$(0.03)** to **$(0.02)** for the three months ended June 30, 2025, and from **$(0.06)** to **$(0.04)** for the six months ended June 30, 2025[40](index=40&type=chunk) - Potentially dilutive common shares are excluded from diluted net loss per share calculations during periods of net loss as their effect would be anti-dilutive[39](index=39&type=chunk) [6. Composition of Certain Financial Statement Items](index=18&type=section&id=6.%20Composition%20of%20Certain%20Financial%20Statement%20Items) This note provides a breakdown of key balance sheet accounts, including cash, receivables, and inventory Cash, Cash Equivalents, and Restricted Cash (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :------------ | :---------------- | | Cash | $2,183 | $3,984 | | Money market funds | $29,335 | $70,613 | | Restricted Cash | $315 | $315 | | **Total** | **$31,833** | **$74,912** | Accounts Receivable, net (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Accounts receivable | $3,661 | $1,695 | | Accounts receivable - related parties | $2,304 | $4,921 | | Less: allowance for credit losses | $(808) | $(330) | | **Total accounts receivable, net** | **$5,157** | **$6,286** | Inventory, net (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :---------------- | :------------ | :---------------- | | Finished goods | $1,520 | $781 | | Work-in-process | $2,574 | $3,213 | | Raw materials | $620 | $427 | | **Total** | **$4,714** | **$4,421** | - The company capitalized costs related to 365-day product inventory starting September 2024 after FDA 510(k) clearance, which resulted in lower cost of sales as pre-clearance inventory was sold[44](index=44&type=chunk) [7. Marketable Securities](index=20&type=section&id=7.%20Marketable%20Securities) This note details the company's investments in marketable securities, including their fair value and maturity profiles Marketable Securities Available for Sale (June 30, 2025, in thousands) | Type | Amortized Cost | Estimated Market Value | | :-------------------------- | :------------- | :--------------------- | | Commercial Paper | $14,384 | $14,382 | | Corporate debt securities | $9,178 | $9,184 | | Government and agency securities | $71,309 | $71,328 | | **Total** | **$94,871** | **$94,894** | - There were no marketable securities held as of December 31, 2024, indicating a significant investment in these assets during the first half of 2025[46](index=46&type=chunk) - The majority of marketable securities mature in 2025 (remaining six months) and 2026[47](index=47&type=chunk) [8. Prepaid Expenses and Other Current Assets](index=20&type=section&id=8.%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) This note provides a breakdown of the company's prepaid expenses and other current assets Prepaid Expenses and Other Current Assets (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Tax credits receivable | $1,793 | $1,793 | | Contract manufacturing | $1,635 | $2,720 | | Clinical and Preclinical | $639 | $689 | | **Total** | **$4,990** | **$5,819** | [9. Accrued Expenses and Other Current Liabilities](index=22&type=section&id=9.%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) This note details the composition of the company's accrued expenses and other current liabilities Accrued Expenses and Other Current Liabilities (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Compensation and benefits | $2,810 | $5,311 | | Professional and administrative services | $2,646 | $1,587 | | Research and development | $2,494 | $3,416 | | Sales and marketing services | $2,093 | $1,287 | | Contract manufacturing | $1,044 | $1,813 | | **Total** | **$12,507** | **$15,506** | [10. Leases](index=22&type=section&id=10.%20Leases) This note outlines the company's operating lease arrangements for its corporate headquarters - The company leases approximately 33,000 square feet of research and office space for its corporate headquarters under a non-cancelable operating lease expiring May 31, 2033[51](index=51&type=chunk) Operating Lease Assets and Liabilities (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Operating lease ROU assets | $4,653 | $4,837 | | Current operating lease liabilities | $462 | $429 | | Non-current operating lease liabilities | $5,548 | $5,785 | | **Total operating lease liabilities** | **$6,010** | **$6,214** | - The weighted-average remaining lease term for operating leases is **7.9 years**, with a weighted-average discount rate of **8.5%** as of June 30, 2025[53](index=53&type=chunk) [11. Product Warranty Obligations](index=24&type=section&id=11.%20Product%20Warranty%20Obligations) This note describes the company's product warranty policy and the associated liability - The company provides a one-year warranty on its smart transmitters and may replace Eversense System components not functioning to specifications[54](index=54&type=chunk) Estimated Warranty Liabilities (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Balance at beginning of the period | $406 | $514 | | Provision for warranties during the period | $185 | $311 | | Settlements made during the period | $(161) | $(419) | | **Balance at end of the period** | **$430** | **$406** | [12. Notes Payable, Preferred Stock and Stock Purchase Warrants](index=24&type=section&id=12.%20Notes%20Payable%2C%20Preferred%20Stock%20and%20Stock%20Purchase%20Warrants) This note details the company's debt instruments, including term loans and the repayment of 2025 Notes - The company entered into a Loan and Security Agreement in September 2023 for up to **$50.0 million** in senior secured term loans, with **$35.0 million** funded as of June 30, 2025[56](index=56&type=chunk)[79](index=79&type=chunk) - The 2025 Notes, with an aggregate principal amount of **$20.4 million** outstanding at December 31, 2024, were fully repaid on January 15, 2025[70](index=70&type=chunk)[79](index=79&type=chunk) Notes Payable Carrying Amounts (in thousands) | Item | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | Loan and Security Agreement | $35,230 | $34,703 | | 2025 Notes | — | $20,138 | | **Total** | **$35,230** | **$54,841** | Interest Expense on Notes Payable (in thousands) | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------- | :--------------------------- | :--------------------------- | | 2025 Notes | $305 | $1,920 | | Loan and Security Agreement | $2,269 | $2,213 | | **Total** | **$2,574** | **$4,133** | [13. Stockholders' Equity](index=32&type=section&id=13.%20Stockholders'%20Equity) This note details changes in the company's equity, including recent public and private offerings Equity Offerings (May 2025) | Offering Type | Gross Proceeds | Net Proceeds | | :-------------------- | :------------- | :----------- | | Public Offering | $57.5 million | $52.1 million | | Private Placement (Abbott) | $20.3 million | $20.1 million | - The Equity Distribution Agreement with Goldman Sachs & Co. LLC was terminated on May 15, 2025, having generated approximately **$30.8 million** in net proceeds from the sale of **40,130,560 shares**[84](index=84&type=chunk) [14. Stock-Based Compensation](index=33&type=section&id=14.%20Stock-Based%20Compensation) This note describes the company's equity incentive plans and employee stock purchase plan - The 2015 Equity Incentive Plan, Inducement Plan, and 2023 Commercial Equity Plan are active for granting stock options and restricted stock units to employees and non-employees[85](index=85&type=chunk)[87](index=87&type=chunk)[88](index=88&type=chunk) - As of June 30, 2025, **28,704,491 shares** remained available for grant under the Amended and Restated 2015 Plan[86](index=86&type=chunk) - The 2016 Employee Stock Purchase Plan (ESPP) allows participants to purchase common stock at **85%** of the lower of the fair market value on the offering or purchase date, with **28,299,743 shares** available for issuance[89](index=89&type=chunk)[90](index=90&type=chunk) [15. Fair Value Measurements](index=35&type=section&id=15.%20Fair%20Value%20Measurements) This note provides information on the fair value hierarchy of the company's financial assets Fair Value Hierarchy of Financial Assets (June 30, 2025, in thousands) | Asset Class | Total | Level 1 | Level 2 | Level 3 | | :-------------------------------- | :---- | :------ | :------ | :------ | | Money market funds | $29,335 | $29,335 | — | — | | Commercial paper (>3 months) | $14,382 | — | $14,382 | — | | Corporate debt securities | $9,183 | — | $9,183 | — | | Government and agency securities (>3 months) | $71,328 | $71,328 | — | — | - As of December 31, 2024, money market funds were the only financial asset measured at fair value on a recurring basis, totaling **$70.6 million**[94](index=94&type=chunk) [16. Income Taxes](index=37&type=section&id=16.%20Income%20Taxes) This note discusses the company's income tax position and the impact of recent tax legislation - The company has not recorded any tax provision or benefit for the three and six months ended June 30, 2025 or 2024, due to a full valuation allowance against net deferred tax assets[95](index=95&type=chunk) - The recently signed One Big Beautiful Bill Act (OBBBA) is being evaluated but is not expected to have a material impact on the company's consolidated financial statements[96](index=96&type=chunk) [17. Related Party Transactions](index=37&type=section&id=17.%20Related%20Party%20Transactions) This note discloses significant transactions with related parties, primarily Ascensia - Ascensia, a related party through its parent company PHC, is a significant customer, accounting for **52%** and **61%** of total revenue for the three and six months ended June 30, 2025, respectively[97](index=97&type=chunk)[98](index=98&type=chunk) Related Party Transactions with Ascensia (in thousands) | Item | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | | Revenue from Ascensia | $7,900 | $8,500 | | Commissions earned by Ascensia | $2,600 | $200 | | Amount due from Ascensia | $2,300 | $4,900 | | Amount due to Ascensia | $2,600 | $1,800 | [18. Segment Information](index=38&type=section&id=18.%20Segment%20Information) This note confirms the company operates as a single reportable segment and provides key expense categories - The company operates as a single reportable segment, deriving revenue from diabetes products and services[101](index=101&type=chunk) Key Expense Categories (in thousands) | Expense Category | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Cost of sales | $3,528 | $4,567 | $8,280 | $9,279 | | Sales and marketing expenses | $2,800 | $1,754 | $4,542 | $3,281 | | Research and development expenses | $7,715 | $10,800 | $15,014 | $21,238 | | General and administrative expenses | $6,929 | $7,237 | $12,881 | $13,838 | [19. Subsequent Events](index=38&type=section&id=19.%20Subsequent%20Events) This note confirms the evaluation of events occurring after the reporting period, with no material disclosures required - The company evaluated all subsequent events through the filing date of this Form 10-Q and found no events requiring recognition or disclosure[104](index=104&type=chunk) [ITEM 2: Management's Discussion and Analysis of Financial Condition and Results of Operations](index=39&type=section&id=ITEM%202%3A%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial condition, operational results, Eversense CGM commercialization, and future product development [Overview](index=39&type=section&id=Overview) This section introduces Senseonics' core business, key product developments, and strategic initiatives - Senseonics is a medical technology company focused on long-term implantable continuous glucose monitoring (CGM) systems, including Eversense E3 (180-day) and Eversense 365 (365-day)[108](index=108&type=chunk) - Eversense 365 received FDA approval in September 2024 and began commercialization in the US in Q4 2024, offering a 365-day extended life CGM system[108](index=108&type=chunk)[123](index=123&type=chunk) - Medicare coverage for Eversense E3 expanded in February 2024 to include all insulin users and non-insulin users with problematic hypoglycemia, significantly increasing patient access[112](index=112&type=chunk) - The company fully transitioned its network of inserters to Eon Care in Q2 2025, expecting this to enable a self-sustaining economic model for insertion services[126](index=126&type=chunk) - First-in-human testing for the next-generation Gemini product, a fully implantable self-powering system with both flash glucose monitoring and traditional CGM capabilities, began in July 2024[128](index=128&type=chunk) - The company plans to submit Eversense 365 for CE Mark approval in Q1 2025, with a potential launch in European markets in H2 2025[130](index=130&type=chunk)[131](index=131&type=chunk) [Financial Overview](index=45&type=section&id=Financial%20Overview) This section summarizes the company's revenue sources, including sales to distributors and consignment models - Revenue is primarily generated from sales of Eversense systems to Ascensia and other distributors, and through a consignment model with healthcare professionals[132](index=132&type=chunk) - Sales to Ascensia accounted for **52%** and **61%** of total revenue for the three and six months ended June 30, 2025, respectively, a decrease from **84%** and **86%** in the prior year, indicating diversification[137](index=137&type=chunk) - Consignment sales significantly increased, accounting for **40.9%** and **32.5%** of total revenue for the three and six months ended June 30, 2025, up from **14.7%** and **11.3%** in the prior year[138](index=138&type=chunk) Revenue by Geographic Region (in thousands) | Region | 3 Months Ended June 30, 2025 | % of Total (2025) | 3 Months Ended June 30, 2024 | % of Total (2024) | | :------------------------ | :--------------------------- | :---------------- | :--------------------------- | :---------------- | | United States | $4,946 | 74.4% | $3,030 | 62.3% | | Outside of the United States | $1,703 | 25.6% | $1,835 | 37.7% | | **Total** | **$6,649** | **100.0%** | **$4,865** | **100.0%** | | Region | 6 Months Ended June 30, 2025 | % of Total (2025) | 6 Months Ended June 30, 2024 | % of Total (2024) | | :------------------------ | :--------------------------- | :---------------- | :--------------------------- | :---------------- | | United States | $9,441 | 73.2% | $6,706 | 67.7% | | Outside of the United States | $3,465 | 26.8% | $3,206 | 32.3% | | **Total** | **$12,906** | **100.0%** | **$9,912** | **100.0%** | [Results of Operations for the Three Months Ended June 30, 2025 and 2024](index=48&type=section&id=Results%20of%20Operations%20for%20the%20Three%20Months%20Ended%20June%2030%2C%202025%20and%202024) This section analyzes the company's financial performance for the three-month periods, highlighting revenue, gross profit, and expense trends Financial Performance (Three Months Ended June 30, in thousands) | Metric | 2025 | 2024 | Period-to-Period Change | | :----------------------------------- | :----- | :----- | :---------------------- | | Total revenue | $6,649 | $4,865 | $1,784 | | Cost of sales | $3,528 | $4,567 | $(1,039) | | Gross profit | $3,121 | $298 | $2,823 | | Research and development expenses | $7,715 | $10,800 | $(3,085) | | Selling, general and administrative expenses | $9,729 | $8,991 | $738 | | Operating loss | $(14,323) | $(19,493) | $5,170 | | Net Loss | $(14,501) | $(20,287) | $5,786 | - Total revenue increased by **$1.78 million**, primarily driven by US sales growth from the consignment program and 365-day product demand[142](index=142&type=chunk) - Gross margin improved significantly to **46.9%** in 2025 from **6.1%** in 2024, due to favorable margins on 365-day product sales, lower fixed manufacturing costs, and a **$0.7 million** VAT recovery[143](index=143&type=chunk) - Research and development expenses decreased by **$3.1 million**, mainly due to the completion of Eversense 365 system clinical trials and development efforts[144](index=144&type=chunk) - Selling, general and administrative expenses increased by **$0.7 million**, driven by higher sales commission expenses to Ascensia and increased personnel costs for Eon Care subsidiaries, partially offset by lower legal expenses[145](index=145&type=chunk) [Results of Operations for the Six Months Ended June 30, 2025 and 2024](index=51&type=section&id=Results%20of%20Operations%20for%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) This section analyzes the company's financial performance for the six-month periods, detailing revenue, gross profit, and expense changes Financial Performance (Six Months Ended June 30, in thousands) | Metric | 2025 | 2024 | Period-to-Period Change | | :----------------------------------- | :----- | :----- | :---------------------- | | Total revenue | $12,906 | $9,912 | $2,994 | | Cost of sales | $8,280 | $9,279 | $(999) | | Gross profit | $4,626 | $633 | $3,993 | | Research and development expenses | $15,014 | $21,238 | $(6,224) | | Selling, general and administrative expenses | $17,423 | $17,119 | $304 | | Operating loss | $(27,811) | $(37,724) | $9,913 | | Net Loss | $(28,760) | $(39,164) | $10,404 | - Total revenue increased by **$3.0 million**, primarily due to sales growth in the US driven by the consignment program and demand for the 365-day product[148](index=148&type=chunk) - Gross margin improved to **35.8%** in 2025 from **6.4%** in 2024, benefiting from favorable margins on 365-day product sales, lower fixed manufacturing costs, VAT recoveries, and the sale of previously expensed inventory[149](index=149&type=chunk) - Research and development expenses decreased by **$6.2 million**, mainly due to the completion of Eversense 365 system clinical trials[150](index=150&type=chunk) - Selling, general and administrative expenses increased by **$0.3 million**, driven by higher sales commission expenses to Ascensia and personnel costs for Eon Care subsidiaries, offset by a decrease in legal expenses[152](index=152&type=chunk) [Liquidity and Capital Resources](index=53&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's financial position, historical funding, and current capital availability - The company has an accumulated deficit of **$976.6 million** as of June 30, 2025, and has historically funded operations through equity, warrants, convertible notes, and debt[154](index=154&type=chunk) - As of June 30, 2025, unrestricted cash, cash equivalents, and marketable securities totaled **$126.4 million**[154](index=154&type=chunk) Recent Equity Financing (May 2025) | Offering Type | Net Proceeds | | :-------------------- | :----------- | | Public Offering | $52.1 million | | Private Placement (Abbott) | $20.1 million | - Management believes the company has sufficient resources for the next twelve months, alleviating prior going concern doubts, due to recent financing and existing cash[161](index=161&type=chunk)[163](index=163&type=chunk) [Cash Flows](index=56&type=section&id=Cash%20Flows) This section analyzes the company's cash flows from operating, investing, and financing activities Summary of Cash Flows (Six Months Ended June 30, in thousands) | Cash Flow Activity | 2025 | 2024 | | :------------------------------------ | :--------- | :--------- | | Net cash used in operating activities | $(25,347) | $(31,404) | | Net cash used in investing activities | $(94,956) | $(18,150) | | Net cash provided by financing activities | $77,224 | $9,016 | | Net decrease in cash, cash equivalents and restricted cash | $(43,079) | $(40,538) | - Net cash used in operating activities decreased by **$6.06 million**, driven by a lower net loss and changes in operating assets and liabilities[166](index=166&type=chunk)[167](index=167&type=chunk) - Net cash used in investing activities increased significantly to **$95.0 million** in 2025, primarily due to **$94.4 million** in marketable securities purchases[168](index=168&type=chunk) - Net cash provided by financing activities increased to **$77.2 million**, mainly from **$72.3 million** in net proceeds from public and private stock offerings, offset by **$20.4 million** repayment of 2025 Notes[170](index=170&type=chunk) [ITEM 3: Quantitative and Qualitative Disclosures About Market Risk](index=58&type=section&id=ITEM%203%3A%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Senseonics is exempt from providing quantitative and qualitative market risk disclosures - The company is exempt from providing quantitative and qualitative disclosures about market risk due to its status as a 'smaller reporting company' under SEC rules[173](index=173&type=chunk) [ITEM 4: Controls and Procedures](index=58&type=section&id=ITEM%204%3A%20Controls%20and%20Procedures) Management assessed disclosure controls and procedures as effective, with no material changes in internal control over financial reporting - Disclosure controls and procedures were evaluated as effective at the reasonable assurance level as of June 30, 2025[174](index=174&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025[175](index=175&type=chunk) [PART II: Other Information](index=58&type=section&id=PART%20II%3A%20Other%20Information) This section provides additional information, including legal proceedings, risk factors, and other required disclosures [ITEM 1: Legal Proceedings](index=58&type=section&id=ITEM%201%3A%20Legal%20Proceedings) The company faces a patent infringement lawsuit, currently stayed pending USPTO Inter Partes Review proceedings and a Director's review - The company is a defendant in a patent infringement lawsuit filed by Cellspin Soft, Inc. in May 2024, alleging infringement of three patents[178](index=178&type=chunk) - The lawsuit is currently stayed pending resolution of Inter Partes Review (IPR) proceedings at the USPTO, which are challenging the validity of the asserted patents[178](index=178&type=chunk) - The IPR proceedings are further stayed pending a sua sponte review by the Acting Director of the USPTO regarding TikTok Inc.'s Chinese ownership status[178](index=178&type=chunk) [ITEM 1A: Risk Factors](index=60&type=section&id=ITEM%201A%3A%20Risk%20Factors) Updated risk factors highlight dependence on Ascensia, early commercialization challenges, trade policy impacts, and talent retention - The company's success is highly dependent on Ascensia's effective marketing and sales of Eversense under the Commercialization Agreement, which may not be successful[182](index=182&type=chunk)[185](index=185&type=chunk) - Challenges to Eversense adoption are being addressed through initiatives like establishing Eon Care for insertion services and increasing direct-to-consumer (DTC) spending[183](index=183&type=chunk) - The company faces difficulties inherent in early commercialization, including expanding sales infrastructure, increasing brand awareness, managing operations, and responding to competitive pressures[186](index=186&type=chunk)[187](index=187&type=chunk)[189](index=189&type=chunk) - International trade policies, including tariffs and trade barriers, pose risks to the global supply chain, production costs, and profitability, with limited ability to pass increased costs to customers due to medical device pricing structures[201](index=201&type=chunk)[203](index=203&type=chunk)[205](index=205&type=chunk) - Future success depends on generating significant sales to achieve profitability and retaining key executives and qualified personnel in a competitive talent market[211](index=211&type=chunk)[212](index=212&type=chunk)[213](index=213&type=chunk) [ITEM 2: Unregistered Sales of Equity Securities and Use of Proceeds](index=72&type=section&id=ITEM%202%3A%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is not applicable to the company for this reporting period - This section is marked as 'Not applicable' for the current reporting period[219](index=219&type=chunk) [ITEM 3: Defaults Upon Senior Securities](index=72&type=section&id=ITEM%203%3A%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company for this reporting period - This section is marked as 'Not applicable' for the current reporting period[220](index=220&type=chunk) [ITEM 4: Mine Safety Disclosures](index=72&type=section&id=ITEM%204%3A%20Mine%20Safety%20Disclosures) This item is not applicable to the company for this reporting period - This section is marked as 'Not applicable' for the current reporting period[221](index=221&type=chunk) [ITEM 5: Other Information](index=72&type=section&id=ITEM%205%3A%20Other%20Information) During the fiscal quarter ended June 30, 2025, a director adopted a Rule 10b5-1 trading plan for the sale of 83,900 shares of common stock, with no sales to be made prior to September 5, 2025 Director Trading Arrangement (Adopted May 29, 2025) | Name and Position | Action | Adoption Date | Rule 10b5-1 | Total Shares to be Sold | Expiration Date | | :---------------- | :----- | :------------ | :---------- | :---------------------- | :-------------- | | Douglas S. Prince, Director | Adopted | 5/29/2025 | X | 83,900 | November 20, 2025 | - No sales will be made under the adopted trading plan prior to September 5, 2025[223](index=223&type=chunk) [ITEM 6: Exhibits](index=73&type=section&id=ITEM%206%3A%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including corporate governance documents and certifications - Exhibits include Amended and Restated Certificate of Incorporation, Bylaws, Securities Purchase Agreement with Abbott Laboratories, and certifications under Sections 302 and 906 of the Sarbanes-Oxley Act[228](index=228&type=chunk) [SIGNATURES](index=74&type=section&id=SIGNATURES) The report is duly signed on behalf of Senseonics Holdings, Inc. by Rick Sullivan, Chief Financial Officer, on August 6, 2025 - The report was signed by Rick Sullivan, Chief Financial Officer, on August 6, 2025[232](index=232&type=chunk)
Senseonics(SENS) - 2025 Q2 - Quarterly Results
2025-08-06 20:00
[Company Overview and Q2 Highlights](index=1&type=section&id=Company%20Overview%20and%20Q2%20Highlights) 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](index=1&type=section&id=Company%20Profile) 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](index=1&type=chunk)[11](index=11&type=chunk) - 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](index=11&type=chunk) [Recent Highlights & Accomplishments](index=1&type=section&id=Recent%20Highlights%20%26%20Accomplishments) 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](index=1&type=chunk)[5](index=5&type=chunk) - 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](index=5&type=chunk) - Completed the transition of service providers to Eon Care, with **38 providers** now supporting patient implants[5](index=5&type=chunk) - CMS updated the Medicare Physician Fee Schedule, providing a full year of Medicare benefit reimbursement for Eversense 365[5](index=5&type=chunk) - 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](index=5&type=chunk) - 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](index=5&type=chunk) [Second Quarter 2025 Financial Performance](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Performance) 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](index=1&type=section&id=Revenue%20Analysis) 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](index=1&type=section&id=Gross%20Profit) 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](index=5&type=chunk)[6](index=6&type=chunk) [Operating Expenses](index=2&type=section&id=Operating%20Expenses) 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](index=2&type=section&id=Research%20and%20Development%20%28R%26D%29%20Expenses) 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](index=6&type=chunk) [Selling, General and Administrative (SG&A) Expenses](index=2&type=section&id=Selling%2C%20General%20and%20Administrative%20%28SG%26A%29%20Expenses) 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](index=7&type=chunk) [Net Loss and Earnings Per Share (EPS)](index=2&type=section&id=Net%20Loss%20and%20Earnings%20Per%20Share%20%28EPS%29) 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](index=8&type=chunk) [Full Year 2025 Financial Outlook](index=2&type=section&id=Full%20Year%202025%20Financial%20Outlook) 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](index=9&type=chunk) [Product and Partner Information](index=2&type=section&id=Product%20and%20Partner%20Information) 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](index=2&type=section&id=About%20Eversense%20Continuous%20Glucose%20Monitoring%20%28CGM%29%20Systems) 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](index=12&type=chunk) - 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](index=12&type=chunk) - Sensor insertion and removal procedures are performed by healthcare providers, and Eversense CGM systems are prescription devices[12](index=12&type=chunk) [Strategic Partnerships](index=3&type=section&id=Strategic%20Partnerships) 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](index=3&type=section&id=Ascensia%20Diabetes%20Care) 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](index=13&type=chunk) - Ascensia also owns the globally recognized CONTOUR® blood glucose monitoring system portfolio, operating in over **100 countries** with approximately **1,400 employees**[13](index=13&type=chunk)[14](index=14&type=chunk) [PHC Holdings Corporation](index=3&type=section&id=PHC%20Holdings%20Corporation) 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](index=15&type=chunk) - 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](index=15&type=chunk) [Condensed Consolidated Financial Statements](index=5&type=section&id=Condensed%20Consolidated%20Financial%20Statements) 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](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=2&type=section&id=Additional%20Information) 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](index=2&type=section&id=Conference%20Call%20and%20Webcast%20Information) 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](index=10&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) 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](index=16&type=chunk) - 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](index=17&type=chunk) [Investor Contact](index=4&type=section&id=Investor%20Contact) 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](index=18&type=chunk)
Senseonics Holdings, Inc. Schedules Second Quarter 2025 Earnings Release and Conference Call for August 6, 2025 at 4:30 P.M. Eastern Time
Globenewswire· 2025-07-16 20:05
Company Overview - Senseonics Holdings, Inc. is a medical technology company focused on developing and manufacturing long-term implantable continuous glucose monitoring (CGM) systems for diabetes management [3] - The company's CGM systems, Eversense 365 and Eversense E3, feature a small sensor that is implanted under the skin and communicates with a smart transmitter worn externally, sending glucose data to a mobile app every 5 minutes [3] Financial Results Announcement - Senseonics plans to release its second quarter 2025 financial results after market close on August 6, 2025 [1] - A conference call to review the company's performance for the second quarter 2025 will take place at 4:30 p.m. (Eastern Time) on the same day, with a webcast available on the company's website [2]
Here's Why Senseonics (SENS) is Poised for a Turnaround After Losing 5.7% in 4 Weeks
ZACKS· 2025-06-18 14:35
Core Viewpoint - Senseonics Holdings (SENS) has experienced significant selling pressure, resulting in a 5.7% decline over the past four weeks, but analysts anticipate improved earnings in the near future [1] Technical Analysis - The Relative Strength Index (RSI) is utilized to determine if a stock is oversold, with a reading below 30 indicating oversold conditions [2] - SENS has an RSI reading of 23.99, suggesting that the heavy selling may be exhausting, indicating a potential rebound towards equilibrium [5] Fundamental Indicators - There is a strong consensus among sell-side analysts to raise earnings estimates for SENS, leading to a 26.3% increase in the consensus EPS estimate over the last 30 days, which typically correlates with price appreciation [7] - SENS holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, indicating a strong potential for a turnaround [8]
Senseonics Holdings, Inc. to Host In-Person and Virtual Analyst Event at ADA 2025: Eversense® 365 Continuous Glucose Monitoring System for People with Diabetes
Globenewswire· 2025-06-04 20:05
Company Overview - Senseonics Holdings, Inc. is a medical technology company focused on developing and manufacturing long-term implantable continuous glucose monitoring (CGM) systems for diabetes management [5] Upcoming Event - The company will host an in-person and virtual analyst event on June 21, 2025, at 8:00 am CT during the American Diabetes Association 85th Scientific Sessions [1] - The event will feature discussions on the next-generation Eversense® 365 CGM system, which has been approved by the FDA for individuals aged 18 and older [2] Event Details - Company management will present alongside Brian Hansen from Ascencia Diabetes Care, who will discuss the commercial launch of Eversense 365, and Gary Graf from Cotton-O'Neil Diabetes and Endocrinology Center, who will share insights on the Eversense system and its insertion procedure [3] - The event will also cover a recently announced partnership with Sequel to integrate with the twiist automated insulin delivery pump and plans to advance the pipeline of implantable CGM technology [3] - A live question and answer session will follow the formal presentations [4]
Senseonics Holdings, Inc. Announces Closing of Public Offering, Including Exercise in Full of the Underwriters' Option to Purchase Additional Shares, and Closing of Private Placement
GlobeNewswire News Room· 2025-05-21 21:06
Core Viewpoint - Senseonics Holdings, Inc. has successfully closed a public offering of 115 million shares at a price of $0.50 per share, raising gross proceeds of $57.5 million before expenses [1][2]. Group 1: Public Offering Details - The public offering included the full exercise of an option by underwriters to purchase an additional 15 million shares [1]. - The offering was conducted under a "shelf" registration statement that became effective on September 12, 2023 [5]. - The offering was managed by TD Cowen and Barclays as joint book-running managers, with RBC Capital Markets and Lake Street as bookrunners [4]. Group 2: Private Placement with Abbott Laboratories - In conjunction with the public offering, Senseonics entered into a stock purchase agreement with Abbott Laboratories, issuing shares representing 4.99% of its outstanding common stock [3]. - Abbott acquired 40,539,265 shares for approximately $20.3 million before offering expenses [3]. Group 3: Use of Proceeds - The net proceeds from both the public offering and private placement will be used to fund the launch of Eversense 365, ongoing product development, working capital, and general corporate purposes [4][9]. Group 4: Company Overview - Senseonics is focused on developing long-term implantable continuous glucose monitoring systems aimed at improving the lives of individuals with diabetes [7]. - The company's Eversense® CGM systems feature a small sensor that is implanted under the skin and communicates with a smart transmitter, sending glucose data to a mobile app every 5 minutes [7].
Revisiting Senseonics After 4 Years: Still A Big Investment Opportunity
Seeking Alpha· 2025-05-21 07:35
Core Insights - Senseonics has been under observation for several years, with a previous bullish article published in March 2021, which did not yield the expected positive results for investors [1] - The investment strategy employed focuses on a value-oriented approach while incorporating reasonably valued growth stocks, emphasizing the importance of buying quality companies at fair prices [1] - The portfolio has shown significant performance variations over the years, with a total return of 4,114% since inception in 2016, and an internal rate of return (IRR) of 51.54% per year [1] Portfolio Performance Summary - 2016: Portfolio return of 1.28%, compared to NASDAQ's 7.50%, resulting in a delta of -6.22% [1] - 2017: Portfolio return of 49.40%, NASDAQ at 28.23%, delta of +21.17% [1] - 2018: Portfolio return of 84.91%, NASDAQ at -3.88%, delta of +88.79% [1] - 2019: Portfolio return of -1.08%, NASDAQ at 35.23%, delta of -36.31% [1] - 2020: Portfolio return of 173.62%, NASDAQ at 43.63%, delta of +129.99% [1] - 2021: Portfolio return of 37.84%, NASDAQ at 21.40%, delta of +16.44% [1] - 2022: Portfolio return of 20.93%, NASDAQ at -33.10%, delta of +54.03% [1] - 2023: Portfolio return of 87.60%, NASDAQ at 43.42%, delta of +44.18% [1] - 2024: Portfolio return of 77.98%, NASDAQ at 29.83%, delta of +48.15% [1]
募资超5亿!雅培入股!365天连续血糖监测系统
思宇MedTech· 2025-05-19 07:59
Core Viewpoint - The article discusses the recent funding activities of Senseonics Holdings, including a $50 million public offering and a $25 million private placement with Abbott, aimed at supporting the commercialization and development of its Eversense 365 continuous glucose monitoring (CGM) system [1][3]. Funding Structure and Use - Senseonics plans to raise approximately $50 million through a public offering, with an additional $25 million from Abbott, totaling $75 million (around 540 million RMB) [1][3]. - The funds will be allocated for commercial expansion of Eversense 365, product development, operational expenses, and debt repayment [3]. Strategic Implications of Abbott's Investment - Abbott will hold approximately 4.99% of Senseonics' common stock post-transaction, indicating a strategic partnership rather than a controlling stake [4]. - The investment allows Abbott to strengthen its position in the evolving CGM market, where competition is increasing from companies like Dexcom and Medtronic [4][6]. - Abbott's investment is seen as a proactive measure to counter potential market disruptions and to diversify its CGM product offerings [6][7]. Eversense 365 Overview - Eversense 365 is the first FDA-approved implantable CGM system that lasts for 365 days, significantly reducing the burden of daily management for patients [8][12]. - The system has a mean absolute relative difference (MARD) of 8.8%, with a 90% sensor function retention rate over a year [12][14]. Competitive Advantages of Eversense 365 - Eversense 365 offers a longer sensor life compared to traditional CGMs, which require frequent replacements every 10 to 14 days [13]. - The system features a removable transmitter, allowing for flexibility in daily activities and reducing skin irritation [15][17]. - It includes built-in alerts for high and low blood sugar levels, enhancing patient safety [16]. Future Product Development - Senseonics is developing two additional products, Gemini and Freedom, which aim to further enhance its product line and adapt to future market needs [11][19]. - These products are expected to play significant roles in closed-loop systems, providing Abbott with strategic options for future growth [7].
Senseonics Announces Pricing of $50 Million Public Offering of Common Stock and Concurrent Private Placement
Globenewswire· 2025-05-16 03:12
Core Viewpoint - Senseonics Holdings, Inc. is conducting a public offering of 100 million shares at $0.50 per share, aiming to raise $50 million before expenses [1] Group 1: Offering Details - The public offering is priced at $0.50 per share, with gross proceeds expected to be $50 million [1] - Underwriters have a 30-day option to purchase an additional 15 million shares at the same price [1] - The offering is set to close on May 19, 2025, pending customary closing conditions [1] Group 2: Underwriters - TD Cowen and Barclays are the joint book-running managers for the offering [2] - RBC Capital Markets and Lake Street are acting as bookrunners [2] Group 3: Concurrent Private Placement - Abbott Laboratories will purchase shares in a separate private placement at $0.50 per share, representing 4.99% of Senseonics' outstanding common stock post-offering [4] - The Concurrent Private Placement is expected to close on May 21, 2025, subject to the public offering's closing [4] Group 4: Use of Proceeds - The net proceeds from both the public offering and the Concurrent Private Placement will be used to fund the launch of Eversense 365, ongoing product development, working capital, and general corporate purposes [5] Group 5: Company Overview - Senseonics is focused on developing long-term implantable continuous glucose monitoring systems for diabetes management [7] - The company's products include Eversense® 365 and Eversense® E3, which feature a small sensor that communicates glucose data to a mobile app every 5 minutes [7]
Senseonics Announces Commencement of $50 Million Public Offering of Common Stock and Concurrent Private Placement
Globenewswire· 2025-05-15 20:05
Core Viewpoint - Senseonics Holdings, Inc. has initiated an underwritten public offering of its common stock, with a potential additional 15% of shares available for underwriters to purchase [1][2]. Group 1: Offering Details - The public offering is subject to market conditions and will be made under a "shelf" registration statement filed with the SEC [3]. - TD Cowen and Barclays are the joint book-running managers for the offering, with RBC Capital Markets and Lake Street acting as bookrunners [2]. - A preliminary prospectus supplement will be filed with the SEC and will be accessible on their website [3]. Group 2: Concurrent Private Placement - Abbott Laboratories has agreed to purchase up to $25 million of Senseonics' common stock in a separate private placement, contingent on the public offering's closing [4]. - The net proceeds from both the public offering and the concurrent private placement will be used to support the launch of Eversense 365, ongoing product development, and general corporate purposes [5]. Group 3: Company Overview - Senseonics is focused on developing long-term implantable continuous glucose monitoring systems for diabetes management, with products like Eversense® 365 and Eversense® E3 [8]. - The company's CGM systems feature a small sensor that is implanted under the skin and communicates glucose data to a mobile app every 5 minutes [8].