Senseonics Holdings, Inc. (SENS) , along with Ascensia Diabetes Care, announced the receipt of the FDA's clearance for the next-generation Eversense 365 continuous glucose monitoring (CGM) system for people with Type 1 and Type 2 diabetes aged 18 years and above. Eversense 365 has been cleared as an integrated CGM (iCGM) system, indicating that it can integrate with compatible medical devices, including insulin pumps, as part of an automated insulin delivery system. Ascensia, a subsidiary of PHC Holdings Co ...

GERMANTOWN, Md., Sept. 06, 2024 (GLOBE NEWSWIRE) -- Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced plans to participate in the upcoming H.C. Wainwright 26th Annual Global Investment Conference, being held in New York, NY. Management is scheduled to participate in the H.C. Wainwright 26th Annual Global Investment Conference ...

Revenue and Growth - Generated revenue of $4.9 million in Q2 2024, representing an 18% growth compared to the prior year period[2] - U.S. revenue was $3.0 million in Q2 2024, up from $1.8 million in Q2 2023, while international revenue was $1.9 million, down from $2.3 million in the prior year period[3] - Total revenue for June 2024 increased to $4.865 million, up from $4.126 million in June 2023[11] - Net revenue from related parties rose to $4.087 million in June 2024, compared to $3.689 million in June 2023[11] - Full-year 2024 global net revenue is expected to be in the range of $22 million to $24 million, with U.S. new patient starts projected to more than double and the global installed base to increase by approximately 50% compared to 2023[7] Profit and Loss - Gross profit decreased to $0.3 million in Q2 2024 from $0.4 million in Q2 2023, primarily due to increased fixed manufacturing costs[3] - Gross profit for June 2024 decreased to $0.298 million from $0.417 million in June 2023[11] - Net loss was $20.3 million in Q2 2024, slightly improved from $20.4 million in Q2 2023, driven by reduced R&D expenses[4] - Operating loss for June 2024 was $19.493 million, slightly improved from $19.868 million in June 2023[11] - Net loss for June 2024 was $20.287 million, compared to $20.423 million in June 2023[11] - Total comprehensive loss for June 2024 was $20.292 million, slightly better than $20.323 million in June 2023[11] - Basic net loss per common share was $0.03 in June 2024, improved from $0.04 in June 2023[11] - Diluted net loss per common share was $0.03 in June 2024, improved from $0.04 in June 2023[11] Cash and Financial Position - Cash, cash equivalents, short-term investments, and restricted cash totaled $84.9 million as of June 30, 2024, with outstanding indebtedness of $56.2 million[4] Research and Development - Research and development expenses dropped to $10.8 million in June 2024 from $12.83 million in June 2023[11] - Began first-in-human testing for the Gemini System, a fully implantable self-powering system for type 2 diabetes patients[2] Product Development and Launches - The 365-day Eversense system is under FDA review, with a planned product launch in Q4 2024[2] - Collaboration with Mercy healthcare system aims for large-scale implementation of Eversense and remote patient monitoring services, with initial insertions planned for Q3 2024[2] - Established Eon Care Services to provide Eversense insertion procedures and training, supporting expanded access to the product[2] Share Information - Basic weighted-average shares outstanding increased to 616,585,664 in June 2024 from 567,125,022 in June 2023[11]

Financial Data and Key Metrics - Q1 2024 total revenue was $5.1 million, representing 22% growth compared to the prior year period [18] - U S revenue for Q1 2024 was $3 7 million, while revenue outside the U S was $1 4 million [18] - Gross profit in Q1 2024 was $0 3 million, a decrease of $0 1 million from the prior year period, primarily due to higher fixed manufacturing costs [85] - Q1 2024 selling, general and administrative expenses were $8 1 million, an increase of $0 4 million compared to the prior year period, driven by corporate, legal, and patent expenses [22] - Operating loss for Q1 2024 was $18 2 million, compared to $19 7 million in Q1 2023, due to decreases in R&D expenses [22] - Total net loss for Q1 2024 was $18 9 million, or a $0 03 loss per share, compared to a net income of $1 3 million in Q1 2023 [98] - Cash, cash equivalents, and short-term investments totaled $99 1 million as of March 31, 2024, with debt and accrued interest at $55 9 million [98] Business Line Data and Key Metrics - The company is advancing its Eversense CGM system, with a focus on Type 2 patients on basal insulin, who historically have lower adoption rates of advanced technologies [2] - The Eversense RPM program aims to provide comprehensive diabetes management, combining CGM with remote patient monitoring to optimize care [6][19] - The company is collaborating with Mercy, a leading healthcare system, to implement a diabetes population management program using Eversense, targeting 30,000 patients across four states [42][51] - The company is working on a next-generation 365-day Eversense product, with a 510(k) submission filed with the FDA, aiming for a Q4 2024 launch [45][94] Market Data and Key Metrics - The company estimates that less than one quarter of patients eligible for CGM are currently using one, indicating significant growth potential [7] - The U S market remains a key focus, with Q1 2024 sales totaling $3 7 million, while international sales were $1 4 million [18] - The collaboration with Mercy is expected to drive growth, with a controlled launch in the St Louis metro area in July 2024, followed by a broader rollout in Q4 [8] Company Strategy and Industry Competition - The company is focusing on integrating Eversense into large health systems and accountable care organizations, leveraging its iCGM designation and RPM program to differentiate itself [14][17] - The iCGM designation allows Eversense to integrate with insulin pumps, positioning it as a strong competitor in the automated insulin delivery market [83][106] - The company is exploring partnerships with insulin pump manufacturers to further enhance its market position [20][72] Management Commentary on Operating Environment and Future Outlook - Management is optimistic about the growth potential of Eversense, particularly with the upcoming 365-day product launch and the RPM program [13][46] - The company expects Q2 2024 revenue to be consistent with Q1, with full-year guidance to be provided at the upcoming ADA conference [35][71] - Management highlighted the importance of the Mercy collaboration as a key growth catalyst, with the potential to replicate the program across other health systems [9][51] Other Important Information - The company has secured iCGM designation from the FDA, allowing Eversense to integrate with insulin pumps and other medical devices [83] - The 365-day Eversense product is expected to reduce calibration frequency and offer a full year of protection from a single sensor, enhancing its competitive position [63] - The company is working on future-generation products, including Gemini and Freedom, which aim to eliminate the need for an on-body transmitter [63] Q&A Session Summary Question: Update on Ascensia's inventory and new patient growth [88] - The company is seeing over 80% growth in new patient additions compared to the prior year, with inventory levels being managed towards normalization [99] Question: Potential impact of the Mercy collaboration and RPM program [54] - The collaboration with Mercy represents a significant opportunity, with 30,000 eligible patients identified The RPM program is designed to be scalable, with fixed costs per patient and reimbursement handled by Mercy [75] Question: Confidence in the 365-day product approval timeline [76] - The company is confident in the 510(k) submission process and is working closely with the FDA to ensure a timely approval, targeting a Q4 2024 launch [94] Question: Commercial implications of the iCGM designation [77] - The iCGM designation opens opportunities for integration with insulin pumps, though the timeline for commercial integration is still under discussion [106] Question: Details on the 30,000 eligible patients in the Mercy system [78] - The 30,000 patients are CGM-eligible but not currently using CGM, primarily Type 2 patients on insulin or with a history of hypoglycemia [104] Question: Economics of the Mercy collaboration and RPM program [92] - The RPM program follows standard healthcare reimbursement models, with fixed costs per patient and no risk-sharing arrangements [102] Question: Competitive dynamics with other CGMs in the Mercy system [107] - Mercy does not intend to switch existing CGM users but will offer Eversense to all patients, with a focus on those not currently using CGM [80]

PART I: Financial Information [ITEM 1: Financial Statements](index=3&type=section&id=ITEM%201%3A%20Financial%20Statements) This section presents the company's unaudited condensed consolidated financial statements, including balance sheets, statements of operations, equity changes, cash flows, and detailed accounting notes [Condensed Consolidated Balance Sheets](index=3&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets and stockholders' equity decreased, while total liabilities increased, driven by a significant rise in current liabilities due to new notes payable Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | March 31, 2024 | December 31, 2023 | | :-------------------------------- | :------------- | :------------------ | | Total assets | $126,516 | $138,220 | | Total liabilities | $69,898 | $64,768 | | Total stockholders' equity | $18,962 | $35,796 | | Cash and cash equivalents | $90,544 | $75,709 | | Short term investments, net | $8,169 | $33,747 | | Note payable, current portion, net | $17,937 | — | [Unaudited Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Income%20%28Loss%29) The company reported a **net loss of $18.9 million** in Q1 2024, a decline from **net income of $1.3 million** in Q1 2023, mainly due to the absence of prior year's exchange-related and derivative fair value gains Unaudited Condensed Consolidated Statements of Operations Highlights (in thousands) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :---------------------------------- | :-------------------------------- | :-------------------------------- | | Total revenue | $5,047 | $4,137 | | Cost of sales | $4,712 | $3,723 | | Gross profit | $335 | $414 | | Operating loss | $(18,232) | $(19,709) | | Total other (expense) income, net | $(645) | $21,033 | | Net (Loss) Income | $(18,877) | $1,324 | | Basic net (loss) income per common share | $(0.03) | $0.00 | | Diluted net (loss) income per common share | $(0.03) | $0.00 | - **Exchange related gain, net** decreased significantly from **$18,776k** in Q1 2023 to **$0k** in Q1 2024[11](index=11&type=chunk) - **Gain on change in fair value of derivatives** decreased significantly from **$5,778k** in Q1 2023 to **$0k** in Q1 2024[11](index=11&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%27%20Equity%20%28Deficit%29) Total stockholders' equity decreased from **$35.8 million** to **$19.0 million**, primarily due to a **net loss of $18.9 million**, partially offset by stock-based compensation and common stock issuances Changes in Stockholders' Equity (in thousands) | Metric | Balance, December 31, 2023 | Net Loss (Q1 2024) | Stock-based compensation expense (Q1 2024) | Balance, March 31, 2024 | | :-------------------------------- | :------------------------- | :----------------- | :----------------------------------------- | :------------------------ | | Total Stockholders' Equity (Deficit) | $35,796 | $(18,877) | $1,801 | $18,962 | - **Issued common stock for vested RSUs and ESPP purchase** contributed **$96k** to additional paid-in capital in Q1 2024[14](index=14&type=chunk) [Unaudited Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash, cash equivalents, and restricted cash increased by **$15.2 million** in Q1 2024, driven by investing and financing activities, offsetting cash used in operations Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :------------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(20,262) | $(19,848) | | Net cash provided by investing activities | $25,379 | $29,947 | | Net cash provided by (used in) financing activities | $10,034 | $(807) | | Net increase in cash, cash equivalents | $15,151 | $9,292 | | Cash, cash equivalents, and restricted cash at ending of period | $90,860 | $45,085 | - **Financing activities shifted from using** **$0.8 million** cash in Q1 2023 to providing **$10.0 million** in Q1 2024, primarily due to proceeds from the issuance of term loans[178](index=178&type=chunk)[179](index=179&type=chunk) [Notes to Unaudited Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes detail financial statements, covering operations, liquidity, accounting policies, revenue, debt, equity, and related party transactions, emphasizing going concern uncertainty and funding strategies [1. Organization and Nature of Operations](index=8&type=section&id=1.%20Organization%20and%20Nature%20of%20Operations) Senseonics Holdings, Inc. is a medical technology company developing and manufacturing long-term, implantable continuous glucose monitoring (CGM) systems - **The company specializes in long-term, implantable continuous glucose monitoring (CGM) systems**[17](index=17&type=chunk) [2. Liquidity and Capital Resources](index=8&type=section&id=2.%20Liquidity%20and%20Capital%20Resources) The company has an **accumulated deficit of $888.1 million**, raising **substantial doubt about its ability to continue as a going concern**, relying on a **$50.0 million Term Loan Facility** and equity offerings for funding - **Accumulated deficit** of **$888.1 million** as of March 31, 2024[19](index=19&type=chunk) - **Unrestricted cash, cash equivalents, and marketable securities** totaled **$98.7 million** as of March 31, 2024[19](index=19&type=chunk) - **Substantial doubt exists regarding the company's ability to continue as a going concern** for the one-year period following the financial statements issuance date, necessitating additional funding[21](index=21&type=chunk) - Secured a **$50.0 million Term Loan Facility**, with Tranche 1 (**$25.0 million**) funded in September 2023 and Tranche 2 (**$10.0 million**) funded in January 2024[23](index=23&type=chunk) - Exchanged up to **$30.8 million** of 2025 Notes for **$7.5 million** cash and **35.1 million common shares** in August 2023[24](index=24&type=chunk) [3. Summary of Significant Accounting Policies](index=12&type=section&id=3.%20Summary%20of%20Significant%20Accounting%20Policies) Financial statements are prepared under U.S. GAAP, with management estimates, operating as a single segment for glucose monitoring products, and evaluating new accounting pronouncements - **Financial statements are prepared in accordance with U.S. GAAP** for interim financial information[31](index=31&type=chunk) - **The company operates in one segment: glucose monitoring products**[33](index=33&type=chunk) - **Evaluating the impact of new accounting standards** ASU No. 2023-07 (Segment Reporting) and ASU No. 2023-09 (Income Tax Disclosures)[34](index=34&type=chunk)[35](index=35&type=chunk) [4. Revenue Recognition](index=14&type=section&id=4.%20Revenue%20Recognition) Revenue primarily comes from Eversense system sales to Ascensia and other distributors, recognized upon customer control or patient consumption, with Ascensia being a key customer and U.S. revenue share increasing in Q1 2024 - **Revenue is derived from sales of Eversense systems** to Ascensia, third-party distributors, and strategic fulfillment partners[38](index=38&type=chunk) - **88%** of total revenue for Q1 2024 (**92%** for Q1 2023) was from Ascensia[41](index=41&type=chunk) Revenue by Geographic Region (in thousands) | Geographic Region | Three Months Ended March 31, 2024 (Amount) | % of Total (2024) | Three Months Ended March 31, 2023 (Amount) | % of Total (2023) | | :---------------- | :----------------------------------------- | :---------------- | :----------------------------------------- | :---------------- | | United States | $3,677 | 72.8% | $2,162 | 52.3% | | Outside of the United States | $1,370 | 27.2% | $1,975 | 47.7% | | Total | $5,047 | 100.0% | $4,137 | 100.0% | [5. Net (Loss) Income per Share](index=15&type=section&id=5.%20Net%20%28Loss%29%20Income%20per%20Share) The company reported a basic and diluted **net loss per common share of $(0.03)** for Q1 2024, compared to **$0.00 net income per share** in Q1 2023, excluding dilutive shares during net loss periods Net (Loss) Income per Share | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :---------------------------------- | :-------------------------------- | :-------------------------------- | | Basic net (loss) income per common share | $(0.03) | $0.00 | | Diluted net (loss) income per common share | $(0.03) | $0.00 | | Basic weighted-average shares outstanding | 614,588,546 | 497,473,222 | - **77,850,384 anti-dilutive shares were outstanding** in Q1 2024, excluded from diluted EPS due to **net loss**[45](index=45&type=chunk) [6. Marketable Securities](index=17&type=section&id=6.%20Marketable%20Securities) Marketable securities decreased from **$33.7 million** to **$8.2 million**, primarily commercial paper and government securities maturing within nine months of 2024, with minor unrealized losses Marketable Securities (in thousands) | Type | March 31, 2024 (Estimated Market Value) | December 31, 2023 (Estimated Market Value) | | :-------------------------- | :-------------------------------------- | :----------------------------------------- | | Commercial Paper | $4,669 | $7,598 | | Corporate debt securities | — | $7,981 | | Government and agency securities | $3,500 | $18,168 | | Total | $8,169 | $33,747 | - **All marketable securities are scheduled to mature** within the remaining nine months of 2024[46](index=46&type=chunk) [7. Inventory, net](index=18&type=section&id=7.%20Inventory%2C%20net) Net inventory decreased from **$8.8 million** to **$8.0 million**, with work-in-process as the largest component and minimal obsolescence provisions Inventory, net (in thousands) | Category | March 31, 2024 | December 31, 2023 | | :--------------- | :------------- | :---------------- | | Finished goods | $2,092 | $2,160 | | Work-in-process | $4,602 | $5,332 | | Raw materials | $1,269 | $1,284 | | Total | $7,963 | $8,776 | - **Less than $0.1 million was recorded for inventory obsolescence** in cost of sales for both Q1 2024 and Q1 2023[48](index=48&type=chunk) [8. Prepaid Expenses and Other Current Assets](index=18&type=section&id=8.%20Prepaid%20Expenses%20and%20Other%20Current%20Assets) Prepaid expenses and other current assets slightly increased to **$7.4 million**, with contract manufacturing deposits remaining the largest component Prepaid Expenses and Other Current Assets (in thousands) | Category | March 31, 2024 | December 31, 2023 | | :-------------------------------- | :------------- | :---------------- | | Contract manufacturing | $3,891 | $4,244 | | Tax credits receivable | $1,793 | $1,793 | | Insurance | $745 | $73 | | Total prepaid expenses and other current assets | $7,434 | $7,266 | [9. Accrued Expenses and Other Current Liabilities](index=18&type=section&id=9.%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) Accrued expenses and other current liabilities decreased to **$11.1 million**, primarily due to a reduction in compensation and benefits Accrued Expenses and Other Current Liabilities (in thousands) | Category | March 31, 2024 | December 31, 2023 | | :-------------------------------- | :------------- | :---------------- | | Research and development | $4,213 | $3,846 | | Professional and administrative services | $2,123 | $673 | | Compensation and benefits | $1,399 | $4,799 | | Total accrued expenses and other current liabilities | $11,105 | $12,689 | [10. Leases](index=19&type=section&id=10.%20Leases) The corporate headquarters operating lease was extended through May 31, 2033, with consistent **$0.2 million** operating lease expense in Q1 2024 and Q1 2023 - **Lease term for corporate headquarters extended** through May 31, 2033, with one five-year extension option[52](index=52&type=chunk) - **Operating lease expense was** **$0.2 million** for both Q1 2024 and Q1 2023[53](index=53&type=chunk) Operating Lease Assets and Liabilities (in thousands) | Metric | March 31, 2024 | December 31, 2023 | | :-------------------------- | :------------- | :---------------- | | Operating lease ROU assets | $5,097 | $5,180 | | Total operating lease liabilities | $6,497 | $6,582 | [11. Product Warranty Obligations](index=19&type=section&id=11.%20Product%20Warranty%20Obligations) The company provides a one-year warranty on smart transmitters; the warranty reserve remained stable at approximately **$0.5 million** in Q1 2024 Product Warranty Liabilities (in thousands) | Metric | March 31, 2024 | December 31, 2023 | | :-------------------------------- | :------------- | :---------------- | | Balance at beginning of the period | $514 | $781 | | Provision for warranties during the period | $66 | $242 | | Settlements made during the period | $(95) | $(509) | | Balance at end of the period | $485 | $514 | [12. Notes Payable, Preferred Stock and Stock Purchase Warrants](index=20&type=section&id=12.%20Notes%20Payable%2C%20Preferred%20Stock%20and%20Stock%20Purchase%20Warrants) Debt includes a **$50.0 million Term Loan Facility** (**$35.0 million** drawn) and **$20.4 million** in 2025 Convertible Senior Notes, with warrants issued and total interest expense decreasing due to debt settlements - Entered into a Loan and Security Agreement for up to **$50.0 million** in senior secured term loans, with **$25.0 million** (Tranche 1) funded in September 2023 and **$10.0 million** (Tranche 2) funded in January 2024[56](index=56&type=chunk) - **The Loan and Security Agreement includes a minimum cash covenant** (**30%** of outstanding loan) and a performance covenant (**net product revenue** on a trailing six-month basis, commencing July 1, 2024)[59](index=59&type=chunk)[61](index=61&type=chunk) - **Issued warrants to Lenders for** **832,362 common shares** with Tranche 1 and **347,887 shares** with Tranche 2 of the **Term Loan Facility**[63](index=63&type=chunk) - **Outstanding 2025 Notes totaled** **$20.4 million** aggregate principal amount as of March 31, 2024, maturing January 15, 2025, with a **5.25%** coupon[97](index=97&type=chunk)[170](index=170&type=chunk) Interest Expense Related to Notes Payable (in thousands) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | 2025 Notes Interest Expense | $947 | $2,233 | | Loan and Security Agreement Interest Expense | $1,100 | — | | 2023 Notes Interest Expense | — | $189 | | PHC Notes Interest Expense | — | $2,230 | | Total Interest Expense | $2,047 | $4,652 | [13. Stockholders' Equity](index=31&type=section&id=13.%20Stockholders%27%20Equity) The company uses 'at the market' offerings for capital; the 2021 Sales Agreement was terminated, and a new Equity Distribution Agreement with Goldman Sachs yielded minimal net proceeds - **Entered into an Equity Distribution Agreement with Goldman Sachs for up to** **$106.6 million** in 'at the market' offerings; received approximately **$0.1 million** in net proceeds from **108,026 shares** as of March 31, 2024[100](index=100&type=chunk) - **The 2021 Sales Agreement with Jefferies was terminated** in August 2023, with **$106.6 million** remaining available for issuance at termination[99](index=99&type=chunk) [14. Stock-Based Compensation](index=31&type=section&id=14.%20Stock-Based%20Compensation) The company maintains several equity incentive plans (2015, Inducement, 2023 Commercial, ESPP) for employees and partners, with significant shares remaining available for grant or issuance - **46,186,700 shares remained available for grant under the Amended and Restated 2015 Plan** as of March 31, 2024[102](index=102&type=chunk) - **7,675,000 shares remained available for grant under the 2023 Commercial Equity Plan** as of March 31, 2024, for non-employees including Ascensia staff[106](index=106&type=chunk) - **22,729,158 shares of common stock were available for issuance under the 2016 ESPP** as of March 31, 2024, with **199,066 shares** purchased in Q1 2024[107](index=107&type=chunk) [15. Fair Value Measurements](index=34&type=section&id=15.%20Fair%20Value%20Measurements) Financial assets and liabilities are categorized into a three-level fair value hierarchy, with money market funds, commercial paper, and government securities as Level 1/2 assets, and 2025 Notes embedded features as Level 3 liabilities Fair Value Hierarchy of Financial Assets and Liabilities (in thousands, as of March 31, 2024) | Category | Total | Level 1 | Level 2 | Level 3 | | :-------------------------------- | :---- | :------ | :------ | :------ | | **Assets** | | | | | | Money market funds | $87,866 | $87,866 | — | — | | Commercial paper | $4,670 | — | $4,670 | — | | Government and agency securities | $3,500 | $3,500 | — | — | | **Liabilities** | | | | | | Embedded features of the 2025 Notes | $102 | — | — | $102 | - **Significant unobservable inputs for Level 3 liabilities** (2025 Notes embedded features) include stock price volatility (**45.0%**), probabilities of conversion provisions (**5.0-95.0%**), and credit spread (**8.80%**)[112](index=112&type=chunk) [16. Income Taxes](index=34&type=section&id=16.%20Income%20Taxes) No tax provision or benefit was recorded for Q1 2024 or Q1 2023, with a full valuation allowance applied to net deferred tax assets due to benefit uncertainty - **No tax provision or benefit recorded** for the three months ended March 31, 2024, or 2023[113](index=113&type=chunk) - **A full valuation allowance is provided for net deferred tax assets** due to uncertainty of future benefit realization[113](index=113&type=chunk) [17. Related Party Transactions](index=34&type=section&id=17.%20Related%20Party%20Transactions) PHC Holdings Corporation and its subsidiary Ascensia Diabetes Care Holdings AG are related parties, with Ascensia being the primary customer, contributing **$4.5 million** in revenue in Q1 2024 - **PHC Holdings Corporation and its subsidiary Ascensia Diabetes Care Holdings AG are related parties**[114](index=114&type=chunk) - **Revenue from Ascensia was $4.5 million** for Q1 2024, an increase from **$3.8 million** in Q1 2023[115](index=115&type=chunk) - **Amount due from Ascensia was $2.8 million** as of March 31, 2024, and **amount due to Ascensia was $1.1 million**[116](index=116&type=chunk) [18. Subsequent Events](index=36&type=section&id=18.%20Subsequent%20Events) No subsequent events requiring recognition or disclosure were identified through the filing date of this Form 10-Q - **No subsequent events requiring recognition or disclosure were identified** through the filing date of the Form 10-Q[117](index=117&type=chunk) [ITEM 2: Management's Discussion and Analysis of Financial Condition and Results of Operations](index=37&type=section&id=ITEM%202%3A%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section discusses the company's financial condition, operations, and liquidity, focusing on implantable CGM systems, commercialization challenges, funding, and reiterating **substantial doubt about its ability to continue as a going concern** [Overview](index=37&type=section&id=Overview) Senseonics is a medical technology company developing and manufacturing long-term implantable continuous glucose monitoring (CGM) systems (Eversense, Eversense XL, E3) with extended sensor life, focusing on early commercialization and strategic partnerships - **The company develops and manufactures long-term, implantable CGM systems** (Eversense, Eversense XL, Eversense E3) for diabetes management[121](index=121&type=chunk) - **Eversense E3 offers up to six months of continuous glucose monitoring**, significantly longer than non-implantable systems (7-14 days)[121](index=121&type=chunk) - **Commercialization efforts focus on driving awareness among intensively managed patients and healthcare providers through strategic partnerships and distribution agreements**[126](index=126&type=chunk) [United States Development and Commercialization of Eversense](index=39&type=section&id=United%20States%20Development%20and%20Commercialization%20of%20Eversense) The company achieved U.S. milestones including FDA approvals for 90-day Eversense, 180-day Eversense E3, and a non-adjunctive indication, with expanded Medicare coverage and a 365-day system FDA 510(k) submission - **FDA approved the 90-day Eversense CGM system** in June 2018 and the **180-day Eversense E3 CGM system** in February 2022[121](index=121&type=chunk)[135](index=135&type=chunk) - Received FDA approval for **non-adjunctive indication** (dosing claim) for Eversense in June 2019, allowing its use for treatment decisions[121](index=121&type=chunk)[131](index=131&type=chunk) - **Medicare coverage for Eversense E3 was expanded** in February 2024 to include all insulin users and non-insulin users with problematic hypoglycemia[124](index=124&type=chunk) - Completed the **ENHANCE pivotal study for the Eversense 365-day system**, supporting a May 2024 **FDA 510(k) submission for a new 365-day product** with once-per-week calibration[125](index=125&type=chunk)[136](index=136&type=chunk) [European Commercialization of Eversense](index=43&type=section&id=European%20Commercialization%20of%20Eversense) The company secured CE marks for Eversense XL (**180-day sensor life**) and Eversense E3, enabling European commercialization, with Ascensia launching Eversense E3 in H2 2022 - **Affixed CE mark for Eversense XL** in September 2017, indicated for up to **180-day sensor life**, with commercialization starting in Q4 2017[137](index=137&type=chunk) - **Affixed CE mark to Eversense E3 CGM system** in June 2022, with Ascensia commencing commercialization in European markets during the second half of 2022[138](index=138&type=chunk) [Financial Overview](index=43&type=section&id=Financial%20Overview) Product revenue comes from Eversense system sales to Ascensia and other partners, recognized upon customer control or patient consumption, with Ascensia as a concentrated customer and U.S. revenue share increasing in Q1 2024 - **Product revenue is generated from sales of Eversense systems** and components to Ascensia, third-party distributors, and strategic fulfillment partners[139](index=139&type=chunk) - **Consignment sales represented approximately 10%** of net sales for Q1 2024, with revenue recognized upon patient consumption[142](index=142&type=chunk) - **Ascensia accounted for 88%** of total revenue in Q1 2024 (**92%** in Q1 2023), indicating high customer concentration[146](index=146&type=chunk) Revenue by Geographic Region (in thousands) | Geographic Region | Three Months Ended March 31, 2024 (Amount) | % of Total (2024) | Three Months Ended March 31, 2023 (Amount) | % of Total (2023) | | :---------------- | :----------------------------------------- | :---------------- | :----------------------------------------- | :---------------- | | United States | $3,677 | 72.8% | $2,162 | 52.3% | | Outside of the United States | $1,370 | 27.2% | $1,975 | 47.7% | | Total | $5,047 | 100.0% | $4,137 | 100.0% | [Results of Operations for the Three Months Ended March 31, 2024 and 2023](index=46&type=section&id=Results%20of%20Operations%20for%20the%20Three%20Months%20Ended%20March%2031%2C%202024%20and%202023) In Q1 2024, total revenue increased by **$0.9 million** to **$5.0 million**, but gross profit decreased due to higher manufacturing costs and increased revenue share to Ascensia, resulting in a **net loss of $18.9 million** due to the absence of prior year's significant gains - **Total revenue increased by $0.9 million** to **$5.0 million** in Q1 2024, primarily due to increased commercial activities and new patients in the United States[151](index=151&type=chunk) - **Gross profit decreased by $0.079 million** to **$0.3 million** in Q1 2024, with gross margin falling from **10.0%** to **6.6%**, mainly due to higher fixed manufacturing costs and an increased revenue share percentage to Ascensia[152](index=152&type=chunk) - **Research and development expenses decreased by $2.0 million** to **$10.4 million** in Q1 2024, driven by a **$2.8 million** reduction in clinical studies spend[153](index=153&type=chunk) - **Total other income (expense), net, decreased by $21.7 million**, shifting from **$21.0 million** income in Q1 2023 to **$(0.6) million** expense in Q1 2024, primarily due to a **$50.0 million** reduction in gains on derivative fair value and debt settlements[156](index=156&type=chunk) Key Financial Results (in thousands) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | Period-to-Period Change | | :---------------------------------- | :-------------------------------- | :-------------------------------- | :---------------------- | | Total revenue | $5,047 | $4,137 | $910 | | Gross profit | $335 | $414 | $(79) | | Research and development expenses | $10,438 | $12,405 | $(1,967) | | Selling, general and administrative expenses | $8,129 | $7,718 | $411 | | Operating loss | $(18,232) | $(19,709) | $1,477 | | Net (Loss) Income | $(18,877) | $1,324 | $(20,201) | [Liquidity and Capital Resources](index=48&type=section&id=Liquidity%20and%20Capital%20Resources) With an **accumulated deficit of $888.1 million** and **$98.7 million** in unrestricted cash, **substantial doubt exists regarding the company's ability to continue as a going concern** through Q2 2025, necessitating debt and equity financings like the **$50.0 million Term Loan Facility** - **Accumulated deficit** of **$888.1 million** as of March 31, 2024[157](index=157&type=chunk) - **Unrestricted cash, cash equivalents, and marketable securities** totaled **$98.7 million** as of March 31, 2024[157](index=157&type=chunk) - **Substantial doubt exists regarding the company's ability to continue as a going concern** for the one-year period following the financial statements issuance date, requiring additional funding[167](index=167&type=chunk)[172](index=172&type=chunk) - Secured a **$50.0 million Term Loan Facility**, with **$35.0 million** drawn as of January 2, 2024[158](index=158&type=chunk)[169](index=169&type=chunk) - **Existing cash and cash equivalents are not expected to be sufficient** to fund operations and meet debt covenants through the second quarter of 2025[167](index=167&type=chunk) [Cash Flows](index=54&type=section&id=Cash%20Flows) In Q1 2024, **$20.3 million** was used in operating activities, offset by **$25.4 million** from investing and **$10.0 million** from financing, leading to a **net increase of $15.2 million** in cash and cash equivalents Summary of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :------------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(20,262) | $(19,848) | | Net cash provided by investing activities | $25,379 | $29,947 | | Net cash provided by (used in) financing activities | $10,034 | $(807) | | Net increase in cash and cash equivalents | $15,151 | $9,292 | - **Net cash provided by financing activities significantly increased** to **$10.0 million** in Q1 2024, primarily from the issuance of term loans, compared to cash used in Q1 2023[178](index=178&type=chunk) [Contractual Obligations](index=54&type=section&id=Contractual%20Obligations) No material changes to contractual obligations and commitments were reported as of March 31, 2024, compared to the Annual Report on Form 10-K - **No material changes in contractual obligations and commitments** as of March 31, 2024, compared to the Annual Report on Form 10-K filed March 1, 2024[180](index=180&type=chunk) [ITEM 3: Quantitative and Qualitative Disclosures About Market Risk](index=56&type=section&id=ITEM%203%3A%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a 'smaller reporting company,' Senseonics is exempt from detailed quantitative and qualitative market risk disclosures in this Form 10-Q - **The company is exempt from providing detailed market risk disclosures** as it is classified as a 'smaller reporting company'[181](index=181&type=chunk) [ITEM 4: Controls and Procedures](index=56&type=section&id=ITEM%204%3A%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of March 31, 2024, with no material changes in internal control over financial reporting identified [Evaluation of Disclosure Controls and Procedures](index=56&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) Management, with executive officers, evaluated and concluded that disclosure controls and procedures were effective at a reasonable assurance level as of March 31, 2024 - **Disclosure controls and procedures were evaluated and deemed effective** at the reasonable assurance level as of March 31, 2024[182](index=182&type=chunk) [Changes in Internal Control over Financial Reporting](index=56&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) No material changes in internal control over financial reporting were identified during Q1 2024 - **No material changes in internal control over financial reporting occurred** during the quarter ended March 31, 2024[183](index=183&type=chunk) PART II: Other Information [ITEM 1: Legal Proceedings](index=57&type=section&id=ITEM%201%3A%20Legal%20Proceedings) The company faces ordinary course litigation, including a dismissed False Claims Act lawsuit and a new patent infringement lawsuit filed in May 2024, which it intends to vigorously defend - **A False Claims Act lawsuit was dismissed** by the District Court, and the dismissal was affirmed by the Fifth Circuit on February 28, 2024[187](index=187&type=chunk) - **A new patent infringement lawsuit was filed** against the company by Cellspin Soft, Inc. in May 2024, which the company intends to vigorously defend[188](index=188&type=chunk) [ITEM 1A: Risk Factors](index=57&type=section&id=ITEM%201A%3A%20Risk%20Factors) The company faces significant risks, including costly patent litigation and **substantial doubt about its ability to maintain sufficient liquidity** to continue as a going concern, necessitating additional capital - **The medical device industry is characterized by patent litigation**, which could be costly, divert management time, and harm the company's reputation[191](index=191&type=chunk)[197](index=197&type=chunk) - **Substantial doubt exists regarding the company's ability to maintain liquidity sufficient to operate effectively**, raising concerns about its ability to continue as a going concern[198](index=198&type=chunk)[201](index=201&type=chunk) - **A new patent infringement lawsuit was filed** in May 2024, adding to the litigation risk[194](index=194&type=chunk) [ITEM 2: Unregistered Sales of Equity Securities and Use of Proceeds](index=61&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 - Not applicable[202](index=202&type=chunk) [ITEM 3: Defaults Upon Senior Securities](index=61&type=section&id=ITEM%203%3A%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company for this reporting period - Not applicable[203](index=203&type=chunk) [ITEM 4: Mine Safety Disclosures](index=61&type=section&id=ITEM%204%3A%20Mine%20Safety%20Disclosures) This item is not applicable to the company for this reporting period - Not applicable[204](index=204&type=chunk) [ITEM 5: Other Information](index=61&type=section&id=ITEM%205%3A%20Other%20Information) No officers or directors adopted, modified, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during Q1 2024 - **No Rule 10b5-1 or non-Rule 10b5-1 trading arrangement changes** by officers or directors in Q1 2024[205](index=205&type=chunk) [ITEM 6: Exhibits](index=62&type=section&id=ITEM%206%3A%20Exhibits) This section lists all exhibits filed or incorporated by reference as part of the Form 10-Q, including corporate documents, Sarbanes-Oxley certifications, and Inline XBRL documents - **Includes certifications under Sections 302 and 906 of the Sarbanes-Oxley Act** and Inline XBRL documents[208](index=208&type=chunk) [SIGNATURES](index=63&type=section&id=SIGNATURES) The Quarterly Report on Form 10-Q was duly signed by Rick Sullivan, Chief Financial Officer, on May 13, 2024 - **Signed by Rick Sullivan, Chief Financial Officer, on May 13, 2024**[212](index=212&type=chunk)

Exhibit 99.1 SENSEONICS HOLDINGS, INC. REPORTS FIRST QUARTER 2024 FINANCIAL RESULTS GERMANTOWN, MD, May 13, 2024 —Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today reported financial results for the quarter ended March 31, 2024. Recent Highlights & Accomplishments: "It has been a very productive start to the year for Senseonics as we c ...

Senseonics Holdings, Inc. (NYSE:SENS) Q4 2023 Earnings Conference Call February 29, 2024 4:30 PM ET Company Participants Trip Taylor - IR Tim Goodnow - President and CEO Rick Sullivan - CFO Mukul Jain - COO Conference Call Participants Marie Thibault - BTIG Vernon Bernardino - H.C. Wainwright Operator Good evening and welcome to the Senseonics Fourth Quarter and Full Year 2023 Earnings Release and Conference Call. All participants will be in listen-only mode. After today's presentation there will be an oppo ...

PART I This part details the company's business operations, significant risks, regulatory compliance, and corporate information [Item 1. Business](index=4&type=section&id=Item%201.%20Business) Senseonics Holdings, Inc. is a medical technology company specializing in long-term implantable continuous glucose monitoring (CGM) systems, primarily Eversense. The company focuses on product development and manufacturing, while its partner, Ascensia Diabetes Care Holdings AG, handles global commercialization, sales, marketing, and customer support. Recent developments include FDA approval and CE mark for the 180-day Eversense E3 system, expanded Medicare coverage, and ongoing pivotal studies for a 365-day sensor. The company's strategy emphasizes increasing market awareness, expanding the inserter network, and securing favorable reimbursement - Senseonics is a medical technology company focused on developing and manufacturing long-term implantable glucose monitoring products, with Eversense E3 CGM system designed for up to six months of continuous glucose measurement[19](index=19&type=chunk) - The company's commercialization strategy relies on an exclusive agreement with Ascensia Diabetes Care Holdings AG for worldwide distribution, with Senseonics responsible for product development and manufacturing, and Ascensia for sales, marketing, and customer support[22](index=22&type=chunk)[41](index=41&type=chunk) - Key recent developments include FDA approval of the 180-day Eversense E3 CGM system in February 2022 and its subsequent commercialization in the U.S. and EEA, as well as expanded Medicare coverage for Eversense E3 to include all insulin users and non-insulin users with problematic hypoglycemia, effective February 25, 2024[23](index=23&type=chunk)[26](index=26&type=chunk) - The ENHANCE pivotal study for a 365-day Eversense system has completed adult enrollment and data analysis, with an FDA submission expected soon for a new product targeting 365-day duration and once-per-week calibration[20](index=20&type=chunk)[54](index=54&type=chunk) [Overview](index=4&type=section&id=Overview) This section provides a general introduction to the company's business and products [Significant Recent Developments](index=5&type=section&id=Significant%20Recent%20Developments) This section highlights key recent achievements and milestones for the company [Background](index=5&type=section&id=Background) This section provides historical context and foundational information about the company [Commercial Strategy](index=6&type=section&id=Commercial%20Strategy) This section outlines the company's approach to market its products and achieve sales growth [Collaboration and Commercialization Agreement with Ascensia Diabetes Care Holdings AG](index=7&type=section&id=Collaboration%20and%20Commercialization%20Agreement%20with%20Ascensia%20Diabetes%20Care%20Holdings%20AG) This section details the strategic partnership for global product commercialization [Clinical Development and Regulatory Pathway](index=7&type=section&id=Clinical%20Development%20and%20Regulatory%20Pathway) This section describes the clinical trials and regulatory processes for product approvals [Overview](index=7&type=section&id=Overview) This section provides a general summary of the clinical development and regulatory process [United States Pivotal Trials](index=8&type=section&id=United%20States%20Pivotal%20Trials) This section details the key clinical trials conducted in the United States for product approval [PRECISE II Trial](index=8&type=section&id=PRECISE%20II%20Trial) This section describes the PRECISE II clinical trial [PROMISE Trial](index=8&type=section&id=PROMISE%20Trial) This section describes the PROMISE clinical trial [ENHANCE Trial](index=9&type=section&id=ENHANCE%20Trial) This section describes the ENHANCE clinical trial [Our Technology](index=9&type=section&id=Our%20Technology) This section describes the core technological components of the company's products [Sensor](index=10&type=section&id=Sensor) This section details the design and function of the glucose sensor [Smart Transmitter](index=10&type=section&id=Smart%20Transmitter) This section describes the features and capabilities of the smart transmitter [Mobile App](index=10&type=section&id=Mobile%20App) This section outlines the functionality of the accompanying mobile application [Future Product Development](index=11&type=section&id=Future%20Product%20Development) This section discusses ongoing and planned initiatives for new product innovation and enhancements [Sales and Marketing](index=11&type=section&id=Sales%20and%20Marketing) This section describes the strategies and activities for promoting and selling products [Reimbursement](index=12&type=section&id=Reimbursement) This section addresses the coverage and payment policies for the company's products [Coverage in the United States](index=12&type=section&id=Coverage%20in%20the%20United%20States) This section details product reimbursement policies within the United States [Coverage Outside the United States](index=12&type=section&id=Coverage%20Outside%20the%20United%20States) This section details product reimbursement policies in international markets [Manufacturing and Quality Assurance](index=13&type=section&id=Manufacturing%20and%20Quality%20Assurance) This section describes the production processes and quality control measures for products [Competition](index=13&type=section&id=Competition) This section analyzes the competitive landscape and key rivals in the market [Intellectual Property](index=14&type=section&id=Intellectual%20Property) This section outlines the company's strategies for protecting its proprietary technologies and innovations [Patents](index=14&type=section&id=Patents) This section details the company's patent portfolio [Trademarks](index=15&type=section&id=Trademarks) This section details the company's registered trademarks [Trade Secrets](index=15&type=section&id=Trade%20Secrets) This section describes the company's protection of confidential business information [Government Regulation](index=15&type=section&id=Government%20Regulation) This section describes the extensive regulatory framework governing the company's operations and products [Regulation by the FDA](index=15&type=section&id=Regulation%20by%20the%20FDA) This section details the regulatory oversight by the U.S. Food and Drug Administration [International Regulation](index=16&type=section&id=International%20Regulation) This section describes regulatory requirements in markets outside the United States [Other Regulatory Requirements](index=19&type=section&id=Other%20Regulatory%20Requirements) This section covers additional regulatory obligations beyond core product approvals [Health Insurance Portability and Accountability Act of 1996 and Other Foreign and State Laws and Regulations Affecting the Transmission, Security and Privacy of Personal Information](index=20&type=section&id=Health%20Insurance%20Portability%20and%20Accountability%20Act%20of%201996%20and%20Other%20Foreign%20and%20State%20Laws%20and%20Regulations%20Affecting%20the%20Transmission%2C%20Security%20and%20Privacy%20of%20Personal%20Information) This section addresses laws governing the privacy and security of health and personal information [Fraud and Abuse Laws](index=20&type=section&id=Fraud%20and%20Abuse%20Laws) This section discusses regulations designed to prevent healthcare fraud and abuse [Federal Anti-Kickback and Self-Referral Laws](index=21&type=section&id=Federal%20Anti-Kickback%20and%20Self-Referral%20Laws) This section details federal laws prohibiting kickbacks and self-referrals in healthcare [Federal False Claims Act & HIPAA](index=22&type=section&id=Federal%20False%20Claims%20Act%20%26%20HIPAA) This section covers federal laws related to false claims and health information privacy [Civil Monetary Penalties Law](index=22&type=section&id=Civil%20Monetary%20Penalties%20Law) This section describes laws imposing civil monetary penalties for certain healthcare offenses [State Fraud and Abuse Provisions](index=22&type=section&id=State%20Fraud%20and%20Abuse%20Provisions) This section outlines state-level regulations addressing fraud and abuse [Physician Payments Sunshine Act](index=23&type=section&id=Physician%20Payments%20Sunshine%20Act) This section details the law requiring disclosure of payments to physicians and teaching hospitals [Healthcare and Regulatory Reform](index=23&type=section&id=Healthcare%20and%20Regulatory%20Reform) This section discusses the impact of broader healthcare and regulatory changes [Brexit and the Regulatory Framework in the United Kingdom](index=24&type=section&id=Brexit%20and%20the%20Regulatory%20Framework%20in%20the%20United%20Kingdom) This section addresses the implications of Brexit on the UK regulatory environment [U.S. Foreign Corrupt Practices Act](index=24&type=section&id=U.S.%20Foreign%20Corrupt%20Practices%20Act) This section covers the U.S. law prohibiting bribery of foreign officials [UK Bribery Act and other anti-corruption laws](index=25&type=section&id=UK%20Bribery%20Act%20and%20other%20anti-corruption%20laws) This section discusses anti-corruption legislation, including the UK Bribery Act [Environmental Health and Safety Regulations](index=25&type=section&id=Environmental%20Health%20and%20Safety%20Regulations) This section outlines compliance with environmental, health, and safety standards [Employees and Human Capital Resources](index=25&type=section&id=Employees%20and%20Human%20Capital%20Resources) This section describes the company's workforce, culture, and human resource management [Culture](index=25&type=section&id=Culture) This section describes the company's organizational culture and values [Employee Health & Wellbeing](index=26&type=section&id=Employee%20Health%20%26%20Wellbeing) This section details initiatives supporting employee health and wellness [Organizational Development](index=26&type=section&id=Organizational%20Development) This section discusses strategies for enhancing organizational effectiveness and growth [Diversity, Equity, and Inclusion](index=26&type=section&id=Diversity%2C%20Equity%2C%20and%20Inclusion) This section outlines the company's commitment to diversity, equity, and inclusion initiatives [Total Rewards](index=26&type=section&id=Total%20Rewards) This section describes the comprehensive compensation and benefits programs for employees [Corporate Information](index=27&type=section&id=Corporate%20Information) This section provides general information about the company's corporate structure and details [Available Information](index=27&type=section&id=Available%20Information) This section specifies where public information about the company can be accessed [Item 1A. Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) The company faces numerous risks, including significant operating losses since inception and uncertainty about future profitability. Its success heavily relies on the commercialization agreement with Ascensia, which carries risks if performance is unsatisfactory. The highly competitive CGM market, lengthy and expensive product development, and extensive governmental regulations (FDA, international) pose substantial challenges. Financial risks include the need for significant sales to achieve profitability, potential fluctuations in operating results, and substantial debt obligations. Operational risks encompass reliance on third-party manufacturers and suppliers, potential product defects, and the need to continuously innovate. Data privacy and security, including the use of AI, are also growing concerns, alongside the volatility of the company's common stock and potential dilution from convertible securities - The company has incurred significant net losses since inception, with a net loss of **$60.4 million in 2023** and an accumulated deficit of **$869.3 million** as of December 31, 2023, and does not expect to be profitable for at least the next several years[167](index=167&type=chunk)[168](index=168&type=chunk) - Future revenue is substantially dependent on the success of the Commercialization Agreement with Ascensia; unsatisfactory performance by Ascensia could adversely affect commercialization efforts and financial results[169](index=169&type=chunk)[171](index=171&type=chunk) - The CGM market is highly competitive, with major players like Dexcom, Medtronic, and Abbott, who possess greater financial resources, established market presence, and advanced technologies (e.g., factory calibration, iCGM indications)[179](index=179&type=chunk)[213](index=213&type=chunk)[216](index=216&type=chunk) - The company faces risks related to its reliance on third-party manufacturers and suppliers, including potential quality defects, inability to secure components, production capacity issues, and disruptions to facilities[191](index=191&type=chunk)[196](index=196&type=chunk)[198](index=198&type=chunk) - Extensive governmental regulations (FDA, international) govern product development, manufacturing, marketing, and sales, with non-compliance potentially leading to fines, recalls, and suspension of marketing authorizations[19](index=19&type=chunk)[92](index=92&type=chunk)[97](index=97&type=chunk)[101](index=101&type=chunk)[115](index=115&type=chunk) - The company's stock price has been highly volatile, influenced by factors such as analyst coverage, clinical trial results, financing activities, regulatory approvals, and broader market conditions[170](index=170&type=chunk)[354](index=354&type=chunk)[356](index=356&type=chunk) [Summary of Risks Affecting Our Business](index=28&type=section&id=Summary%20of%20Risks%20Affecting%20Our%20Business) This section provides a high-level overview of the principal risks impacting the company's operations [Risks Relating to our Business and our Industry](index=29&type=section&id=Risks%20Relating%20to%20our%20Business%20and%20our%20Industry) This section details specific risks inherent to the company's business model and the broader industry [Risks Related to our Financial Results and Need for Financing](index=43&type=section&id=Risks%20Related%20to%20our%20Financial%20Results%20and%20Need%20for%20Financing) This section outlines financial risks, including profitability, liquidity, and capital requirements [Risks Related to Development of our Products](index=45&type=section&id=Risks%20Related%20to%20Development%20of%20our%20Products) This section addresses challenges and uncertainties associated with product research and development [Risks Related to Employee Matters and Managing our Growth](index=46&type=section&id=Risks%20Related%20to%20Employee%20Matters%20and%20Managing%20our%20Growth) This section covers risks associated with human capital, organizational growth, and management [Risks Related to our Intellectual Property](index=48&type=section&id=Risks%20Related%20to%20our%20Intellectual%20Property) This section discusses potential threats to the company's patents, trademarks, and trade secrets [Risks Related to our Legal and Regulatory Environment](index=52&type=section&id=Risks%20Related%20to%20our%20Legal%20and%20Regulatory%20Environment) This section addresses compliance risks, potential litigation, and the impact of evolving regulations [Risks Related to our Common Stock](index=63&type=section&id=Risks%20Related%20to%20our%20Common%20Stock) This section outlines factors that could affect the trading price and liquidity of the company's stock [Item 1B. Unresolved Staff Comments](index=68&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reported no unresolved staff comments from the SEC - No unresolved staff comments were reported[386](index=386&type=chunk) [Item 1C. Cybersecurity](index=68&type=section&id=Item%201C.%20Cybersecurity) The company has implemented various information security processes to identify, assess, and manage cybersecurity risks to its critical systems and data. This includes monitoring threats, conducting vulnerability assessments, and maintaining technical, physical, and organizational security measures. Cybersecurity risk management is integrated into the company's overall risk management, with oversight from the board's audit committee and active involvement from the executive team and head of IT - The company maintains information security processes to identify, assess, and manage cybersecurity threats to its Information Systems and Data, utilizing methods like manual/automated tools, threat environment scans, external audits, and vulnerability assessments[387](index=387&type=chunk)[388](index=388&type=chunk) - Implemented security measures include incident detection and response, disaster recovery, data encryption, network security controls, access controls, vendor risk management, employee training, penetration testing, and cybersecurity insurance[389](index=389&type=chunk) - Cybersecurity risk management is integrated into the company's overall risk management, with the board of directors' audit committee overseeing the processes and the executive team, along with the head of IT, responsible for implementation and incident response[390](index=390&type=chunk)[394](index=394&type=chunk)[395](index=395&type=chunk)[396](index=396&type=chunk)[397](index=397&type=chunk)[398](index=398&type=chunk) [Risk management and strategy](index=68&type=section&id=Risk%20management%20and%20strategy) This section outlines the company's approach to identifying, assessing, and mitigating cybersecurity risks [Governance](index=69&type=section&id=Governance) This section describes the oversight structure for cybersecurity risk management within the company [Item 2. Properties](index=69&type=section&id=Item%202.%20Properties) The company's principal offices are located in Germantown, Maryland, occupying approximately 33,000 square feet under a lease expiring in 2033. An additional 30,500 square feet of office space, decommissioned in 2021, had its lease expire in 2023. The company believes its current facilities are adequate and plans to expand as needed - The company's principal offices are in Germantown, Maryland, with approximately **33,000 square feet** of research and office space under a lease expiring in **2033**[399](index=399&type=chunk) - An additional **30,500 square feet** of office space, decommissioned in 2021, had its non-cancellable operating sub-lease agreement expire in **2023**[399](index=399&type=chunk) [Item 3. Legal Proceedings](index=70&type=section&id=Item%203.%20Legal%20Proceedings) The company was subject to a civil complaint alleging False Claims Act violations related to marketing practices for its Eversense CGM system. The District Court dismissed the complaint, and this decision was affirmed by the Fifth Circuit on February 28, 2024. Currently, the company is not a party to any other material legal proceedings - A civil complaint alleging False Claims Act violations regarding Eversense CGM system marketing practices was dismissed by the District Court on March 30, 2023, and this dismissal was affirmed by the Fifth Circuit on February 28, 2024[401](index=401&type=chunk) - The company is not currently involved in any other material legal proceedings, nor is it aware of any pending or threatened legal actions that could significantly impact its business, operating results, or financial condition[402](index=402&type=chunk) [Item 4. Mine Safety Disclosures](index=70&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - The company is not subject to mine safety disclosures[403](index=403&type=chunk) PART II This part provides financial market information, management's discussion and analysis, audited financial statements, and disclosures on internal controls [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=70&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock is listed on the NYSE American under the symbol "SENS." As of February 23, 2024, there were 530,668,435 shares of common stock outstanding held by 168 record holders. The company has never declared or paid cash dividends and intends to retain future earnings for business operations and expansion, with current debt agreements further restricting dividend payments - The company's common stock is traded on the NYSE American under the symbol "**SENS**"[405](index=405&type=chunk) - As of February 23, 2024, there were **530,668,435 shares** of common stock outstanding, held by **168 record holders**[5](index=5&type=chunk)[406](index=406&type=chunk) - The company has never paid cash dividends and plans to retain all future earnings for business operations and expansion; current debt agreements also restrict dividend payments[367](index=367&type=chunk)[405](index=405&type=chunk) [Market Information for Common Stock](index=70&type=section&id=Market%20Information%20for%20Common%20Stock) This section provides details on the trading market for the company's common stock [Dividend Policy](index=70&type=section&id=Dividend%20Policy) This section outlines the company's approach to dividend payments to shareholders [Stockholders](index=70&type=section&id=Stockholders) This section provides information regarding the company's shareholders [Recent Sales of Unregistered Securities](index=70&type=section&id=Recent%20Sales%20of%20Unregistered%20Securities) This section details any recent issuances of securities not registered under the Securities Act [Item 6. [Reserved]](index=71&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved and contains no information [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=71&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides an overview of Senseonics' financial condition and operational results, highlighting its focus on implantable CGM systems like Eversense E3. The company reported a significant increase in total revenue for 2023, driven by commercial activities and a full year of E3 sales, despite a decrease in gross margin due to sales channel mix and increased manufacturing costs. Research and development expenses rose due to investments in next-generation technologies and clinical studies. The company undertook several financing transactions in 2023 to strengthen its balance sheet, including a new term loan facility and warrant issuances. Cash flow analysis shows increased cash used in operations but a net increase in cash and cash equivalents due to investing and financing activities Consolidated Statements of Operations and Comprehensive (Loss) Income (in thousands) | | 2023 | 2022 | Period Change | | :--- | :--- | :--- | :--- | | **Total revenue** | **$22,390** | **$16,389** | **$6,001** | | Cost of sales | 19,299 | 13,663 | 5,636 | | **Gross profit** | **$3,091** | **$2,726** | **$365** | | Research and development expenses | 48,752 | 39,719 | 9,033 | | Selling, general and administrative expenses | 29,942 | 31,634 | (1,692) | | **Operating loss** | **($75,603)** | **($68,627)** | **($6,976)** | | Total other income, net | 15,211 | 210,746 | (195,535) | | **Net (Loss) Income** | **($60,392)** | **$142,119** | **($202,511)** | - Total revenue increased by **$6.0 million (36.6%)** to **$22.4 million** in 2023 from **$16.4 million** in 2022, primarily due to increased commercial activities, new patients, and a full year of Eversense E3 revenue, partially offset by lower international sales[443](index=443&type=chunk) - Gross profit increased by **$0.4 million** to **$3.1 million** in 2023, but gross margin decreased from **16.6%** in 2022 to **13.8%** in 2023, mainly due to sales channel mix and higher raw material prices impacting contract manufacturing costs[444](index=444&type=chunk) - Research and development expenses increased by **$9.1 million** to **$48.8 million** in 2023, driven by investments in next-generation technologies, clinical studies, and an expanded R&D workforce[445](index=445&type=chunk)[447](index=447&type=chunk) - The company completed several financing transactions in 2023, including a **$25.0 million** initial term loan (with an additional **$10.0 million** funded in January 2024), issuance of pre-funded warrants for **$15.0 million**, and exchanges of 2025 Notes for cash and common stock, to strengthen its balance sheet[451](index=451&type=chunk)[452](index=452&type=chunk)[453](index=453&type=chunk)[455](index=455&type=chunk) Summary of Cash Flows (in thousands) | | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($70,163) | ($66,312) | | Net cash provided by investing activities | $89,713 | $26,882 | | Net cash provided by financing activities | $20,366 | $41,762 | | Net increase in cash and cash equivalents | $39,916 | $2,332 | [Overview](index=71&type=section&id=Overview) This section provides a general introduction to the company's financial performance and outlook [Critical Accounting Estimates](index=74&type=section&id=Critical%20Accounting%20Estimates) This section discusses accounting policies that require significant judgment and estimation [Revenue](index=74&type=section&id=Revenue) This section details the critical accounting estimates related to revenue recognition [Derivative Financial Instruments](index=75&type=section&id=Derivative%20Financial%20Instruments) This section discusses critical accounting estimates for derivative financial instruments [Results of Operations](index=76&type=section&id=Results%20of%20Operations) This section analyzes the company's financial performance over specified periods [Comparison of the Years Ended December 31, 2023 and 2022](index=76&type=section&id=Comparison%20of%20the%20Years%20Ended%20December%2031%2C%202023%20and%202022) This section compares the financial results for the fiscal years 2023 and 2022 [Components of Results of Operations](index=76&type=section&id=Components%20of%20Results%20of%20Operations) This section breaks down the individual elements contributing to the company's operating results [Total revenue](index=76&type=section&id=Total%20revenue) This section analyzes the company's total revenue streams [Cost of sales and gross profit](index=76&type=section&id=Cost%20of%20sales%20and%20gross%20profit) This section examines the cost of goods sold and resulting gross profit [Research and development expenses](index=76&type=section&id=Research%20and%20development%20expenses) This section details expenditures on research and development activities [Selling, general and administrative expenses](index=77&type=section&id=Selling%2C%20general%20and%20administrative%20expenses) This section analyzes expenses related to sales, marketing, and general corporate administration [Total other income, net](index=77&type=section&id=Total%20other%20income%2C%20net) This section covers non-operating income and expenses [Liquidity and Capital Resources](index=77&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's ability to meet its short-term and long-term financial obligations [Warrants](index=79&type=section&id=Warrants) This section discusses the company's outstanding warrants [Indebtedness](index=80&type=section&id=Indebtedness) This section details the company's debt obligations and financing arrangements [Loan and Security Agreement](index=80&type=section&id=Loan%20and%20Security%20Agreement) This section describes the terms of the company's loan and security agreement [PPP Loan](index=80&type=section&id=PPP%20Loan) This section provides information on the Paycheck Protection Program loan [Convertible Notes](index=80&type=section&id=Convertible%20Notes) This section details the company's convertible debt instruments [Funding Requirements and Outlook](index=80&type=section&id=Funding%20Requirements%20and%20Outlook) This section discusses future capital needs and the company's financial projections [Cash Flows](index=81&type=section&id=Cash%20Flows) This section analyzes the sources and uses of cash from operating, investing, and financing activities [Net cash used in operating activities](index=81&type=section&id=Net%20cash%20used%20in%20operating%20activities) This section details cash flows generated or used by the company's core business operations [Net cash provided by investing activities](index=81&type=section&id=Net%20cash%20provided%20by%20investing%20activities) This section describes cash flows related to the purchase or sale of assets [Net cash provided by financing activities](index=81&type=section&id=Net%20cash%20provided%20by%20financing%20activities) This section outlines cash flows from debt, equity, and dividend transactions [Item 7A. Quantitative and Qualitative Disclosures About Market Risk](index=82&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risk exposures are interest rate risk and foreign currency risk. Interest rate risk is minimal due to short-term maturities of cash equivalents and fixed interest rates on notes payable. Foreign currency risk arises from Euro-denominated international sales, but transaction gains and losses have not been material, and the company does not currently use hedging transactions - The company's primary market risk is interest rate sensitivity, but due to short-term maturities of cash equivalents and fixed interest rates on notes payable, an immediate **100 basis point** change in interest rates would not materially affect the fair value of cash equivalents[487](index=487&type=chunk) - Foreign currency risk stems from Euro-denominated international sales, where currency fluctuations can impact U.S. dollar revenue. However, foreign currency transaction gains and losses have not been material, and the company does not currently engage in hedging[488](index=488&type=chunk) [Interest Rate Risk](index=82&type=section&id=Interest%20Rate%20Risk) This section assesses the company's exposure to fluctuations in interest rates [Foreign Currency Risk](index=82&type=section&id=Foreign%20Currency%20Risk) This section evaluates the company's exposure to changes in foreign exchange rates [Item 8. Financial Statements and Supplementary Data](index=83&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the audited consolidated financial statements for Senseonics Holdings, Inc. and its subsidiary for the years ended December 31, 2023, and 2022. It includes the Independent Registered Public Accounting Firm's report, consolidated balance sheets, statements of operations and comprehensive loss, statements of changes in stockholders' equity, and statements of cash flows. Detailed notes to the financial statements provide critical accounting estimates, revenue recognition policies, information on marketable securities, inventory, debt, equity, stock-based compensation, income taxes, related party transactions, fair value measurements, litigation, and subsequent events - KPMG LLP provided an unqualified opinion on the consolidated financial statements for the years ended December 31, 2023 and 2022, stating they present fairly, in all material respects, the financial position, results of operations, and cash flows in conformity with U.S. GAAP[492](index=492&type=chunk) Consolidated Balance Sheets (in thousands) | | December 31, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Total assets** | **$138,220** | **$177,673** | | Total current liabilities | $17,257 | $31,471 | | Long-term debt and notes payables, net | $41,195 | $56,383 | | Derivative liabilities | $102 | $52,050 | | Other liabilities | $6,214 | $2,689 | | **Total liabilities** | **$64,768** | **$142,593** | | Total temporary equity | $37,656 | $37,656 | | **Total stockholders' equity (deficit)** | **$35,796** | **($2,576)** | Consolidated Statements of Operations and Comprehensive (Loss) Income (in thousands) | | 2023 | 2022 | | :--- | :--- | :--- | | Total revenue | $22,390 | $16,389 | | Gross profit | $3,091 | $2,726 | | Operating loss | ($75,603) | ($68,627) | | Total other income, net | $15,211 | $210,746 | | Net (Loss) Income | ($60,392) | $142,119 | | Total comprehensive (loss) income | ($59,725) | $141,653 | | Basic net (loss) income per common share | ($0.11) | $0.30 | | Diluted net loss per common share | ($0.11) | ($0.11) | Consolidated Statements of Cash Flows (in thousands) | | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($70,163) | ($66,312) | | Net cash provided by investing activities | $89,713 | $26,882 | | Net cash provided by financing activities | $20,366 | $41,762 | | Net increase in cash and cash equivalents | $39,916 | $2,332 | | Cash and cash equivalents, at ending of period | $75,709 | $35,793 | - The company's accumulated deficit reached **$869.3 million** as of December 31, 2023, reflecting substantial operating losses since inception, primarily from R&D and commercial launch activities[514](index=514&type=chunk) - As of December 31, 2023, the company had **$109.5 million** in cash, cash equivalents, and marketable securities, and management believes existing resources will meet anticipated operating needs for at least the next twelve months[450](index=450&type=chunk)[514](index=514&type=chunk)[524](index=524&type=chunk) [Report of KPMG LLP, Auditor ID:185, Independent Registered Public Accounting Firm](index=84&type=section&id=Report%20of%20KPMG%20LLP%2C%20Auditor%20ID%3A185%2C%20Independent%20Registered%20Public%20Accounting%20Firm) This section contains the independent auditor's report on the company's financial statements [Consolidated Balance Sheets as of December 31, 2023 and 2022](index=85&type=section&id=Consolidated%20Balance%20Sheets%20as%20of%20December%2031%2C%202023%20and%202022) This section presents the company's financial position at the end of 2023 and 2022 [Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2023 and 2022](index=86&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss%20for%20the%20years%20ended%20December%2031%2C%202023%20and%202022) This section presents the company's financial performance for the fiscal years 2023 and 2022 [Consolidated Statements of Changes in Stockholders' Equity for the years ended December 31, 2023 and 2022](index=87&type=section&id=Consolidated%20Statements%20of%20Changes%20in%20Stockholders%27%20Equity%20for%20the%20years%20ended%20December%2031%2C%202023%20and%202022) This section details changes in the company's equity accounts for 2023 and 2022 [Consolidated Statements of Cash Flows for the years ended December 31, 2023 and 2022](index=88&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20years%20ended%20December%2031%2C%202023%20and%202022) This section presents the company's cash inflows and outflows for the fiscal years 2023 and 2022 [Notes to Consolidated Financial Statements](index=89&type=section&id=Notes%20to%20Consolidated%20Financial%20Statements) This section provides detailed explanations and additional information supporting the financial statements [1. Organization](index=89&type=section&id=1.%20Organization) This section describes the company's legal structure and business operations [2. Liquidity and Capital Resources](index=89&type=section&id=2.%20Liquidity%20and%20Capital%20Resources) This section details the company's financial liquidity and available capital [3. Summary of Significant Accounting Policies](index=91&type=section&id=3.%20Summary%20of%20Significant%20Accounting%20Policies) This section outlines the key accounting principles and methods used in preparing financial statements [Basis of Presentation](index=91&type=section&id=Basis%20of%20Presentation) This section describes the foundational principles for presenting the financial statements [Use of Estimates](index=91&type=section&id=Use%20of%20Estimates) This section explains the role of management's estimates in financial reporting [Cash and Cash Equivalents and Concentration of Credit Risk](index=92&type=section&id=Cash%20and%20Cash%20Equivalents%20and%20Concentration%20of%20Credit%20Risk) This section details cash, cash equivalents, and credit risk concentrations [Marketable Securities](index=92&type=section&id=Marketable%20Securities) This section describes the accounting for marketable securities [Inventory and Obsolescence](index=92&type=section&id=Inventory%20and%20Obsolescence) This section details the accounting policies for inventory and obsolescence [Accounts Receivable](index=92&type=section&id=Accounts%20Receivable) This section describes the accounting for accounts receivable [Property and Equipment, net](index=93&type=section&id=Property%20and%20Equipment%2C%20net) This section details the accounting for property and equipment [Leases](index=93&type=section&id=Leases) This section describes the accounting for lease arrangements [Impairment of Long-lived Assets](index=93&type=section&id=Impairment%20of%20Long-lived%20Assets) This section details the accounting policy for impairment of long-lived assets [Derivative Financial Instruments](index=93&type=section&id=Derivative%20Financial%20Instruments) This section describes the accounting for derivative financial instruments [Product Warranty Obligations](index=94&type=section&id=Product%20Warranty%20Obligations) This section details the accounting for product warranty liabilities [Revenue Recognition](index=94&type=section&id=Revenue%20Recognition) This section outlines the company's policies for recognizing revenue [Cost of Sales](index=95&type=section&id=Cost%20of%20Sales) This section describes the accounting for the cost of goods sold [Research and Development Expenses](index=95&type=section&id=Research%20and%20Development%20Expenses) This section details the accounting for research and development expenditures [Selling, General and Administrative Expenses](index=95&type=section&id=Selling%2C%20General%20and%20Administrative%20Expenses) This section describes the accounting for selling, general, and administrative costs [Stock-Based Compensation](index=95&type=section&id=Stock-Based%20Compensation) This section details the accounting for stock-based compensation plans [Income Taxes](index=96&type=section&id=Income%20Taxes) This section describes the accounting for income taxes [Fair Value of Financial Instruments](index=96&type=section&id=Fair%20Value%20of%20Financial%20Instruments) This section details the fair value measurement of financial instruments [Recent Accounting Pronouncements](index=96&type=section&id=Recent%20Accounting%20Pronouncements) This section discusses the impact of newly issued accounting standards [4. Revenue Recognition](index=97&type=section&id=4.%20Revenue%20Recognition) This section provides detailed information on the company's revenue recognition policies [Revenues by geographic region](index=97&type=section&id=Revenues%20by%20geographic%20region) This section breaks down revenue generated from different geographical areas [Contract Assets](index=97&type=section&id=Contract%20Assets) This section describes the company's contract assets [Concentration of Revenues and Customers](index=97&type=section&id=Concentration%20of%20Revenues%20and%20Customers) This section identifies significant concentrations in revenue and customer base [5. Net Income (Loss) per Share](index=97&type=section&id=5.%20Net%20Income%20(Loss)%20per%20Share) This section details the calculation of basic and diluted net income or loss per share [6. Marketable Securities](index=99&type=section&id=6.%20Marketable%20Securities) This section provides detailed information on the company's marketable securities [7. Inventory, net](index=99&type=section&id=7.%20Inventory%2C%20net) This section details the company's inventory balances and related accounting [8. Prepaid expenses and other current assets](index=100&type=section&id=8.%20Prepaid%20expenses%20and%20other%20current%20assets) This section details the company's prepaid expenses and other current assets [9. Property and Equipment, net](index=100&type=section&id=9.%20Property%20and%20Equipment%2C%20net) This section provides detailed information on the company's property and equipment [10. Accrued Expenses and Other Current Liabilities](index=101&type=section&id=10.%20Accrued%20Expenses%20and%20Other%20Current%20Liabilities) This section details the company's accrued expenses and other current liabilities [11. Leases](index=101&type=section&id=11.%20Leases) This section provides detailed information on the company's lease obligations [12. 401(k) Plan](index=102&type=section&id=12.%20401(k)%20Plan) This section describes the company's 401(k) retirement plan [13. Notes Payable, Preferred Stock and Stock Purchase Warrants](index=102&type=section&id=13.%20Notes%20Payable%2C%20Preferred%20Stock%20and%20Stock%20Purchase%20Warrants) This section details the company's debt instruments, preferred stock, and warrants [Term Loans](index=102&type=section&id=Term%20Loans) This section describes the company's term loan agreements [Loan and Security Agreement](index=102&type=section&id=Loan%20and%20Security%20Agreement) This section details the terms of the company's loan and security agreement [PPP Loan](index=104&type=section&id=PPP%20Loan) This section provides information on the Paycheck Protection Program loan [Convertible Preferred Stock and Warrants](index=104&type=section&id=Convertible%20Preferred%20Stock%20and%20Warrants) This section details the company's convertible preferred stock and associated warrants [Equity Line Agreement](index=104&type=section&id=Equity%20Line%20Agreement) This section describes the company's equity line agreement [Securities Purchase Agreement](index=105&type=section&id=Securities%20Purchase%20Agreement) This section details the terms of the securities purchase agreement [Convertible Notes](index=105&type=section&id=Convertible%20Notes) This section provides detailed information on the company's convertible notes [PHC Notes](index=105&type=section&id=PHC%20Notes) This section describes the PHC convertible notes [2025 Notes](index=107&type=section&id=2025%20Notes) This section details the convertible notes due in 2025 [2023 Notes](index=109&type=section&id=2023%20Notes) This section describes the convertible notes due in 2023 [14. Stockholders' Deficit](index=110&type=section&id=14.%20Stockholders%27%20Deficit) This section details the components of the company's stockholders' deficit [Common Stock](index=110&type=section&id=Common%20Stock) This section provides information on the company's common stock [Preferred Stock](index=111&type=section&id=Preferred%20Stock) This section provides information on the company's preferred stock [Voting Rights](index=111&type=section&id=Voting%20Rights) This section describes the voting rights associated with the company's shares [Dividends](index=111&type=section&id=Dividends) This section outlines the company's dividend policy and history [Conversion Rights](index=111&type=section&id=Conversion%20Rights) This section details the conversion rights of certain securities [Stock Purchase Warrants](index=111&type=section&id=Stock%20Purchase%20Warrants) This section provides information on the company's stock purchase warrants [15. Stock-Based Compensation](index=112&type=section&id=15.%20Stock-Based%20Compensation) This section details the accounting for stock-based compensation plans and awards [2015 Plan](index=112&type=section&id=2015%20Plan) This section describes the company's 2015 stock incentive plan [Inducement Plan](index=112&type=section&id=Inducement%20Plan) This section details the company's inducement equity plan [Commercial Equity Plan](index=112&type=section&id=Commercial%20Equity%20Plan) This section describes the company's commercial equity plan [2016 Employee Stock Purchase Plan](index=113&type=section&id=2016%20Employee%20Stock%20Purchase%20Plan) This section details the company's 2016 employee stock purchase plan [1997 Plan](index=113&type=section&id=1997%20Plan) This section describes the company's 1997 stock incentive plan [Stock Options](index=113&type=section&id=Stock%20Options) This section provides information on the company's stock option awards [Restricted Stock Units](index=115&type=section&id=Restricted%20Stock%20Units) This section details the company's restricted stock unit awards [16. Income Taxes](index=117&type=section&id=16.%20Income%20Taxes) This section provides detailed information on the company's income tax position [17. Related Party Transactions](index=118&type=section&id=17.%20Related%20Party%20Transactions) This section details transactions between the company and its related parties [18. Fair Value Measurements](index=119&type=section&id=18.%20Fair%20Value%20Measurements) This section provides information on the fair value of financial instruments [19. Litigation](index=121&type=section&id=19.%20Litigation) This section details any ongoing or pending legal disputes involving the company [20. Subsequent Events](index=121&type=section&id=20.%20Subsequent%20Events) This section describes significant events occurring after the balance sheet date [Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=122&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reported no changes in or disagreements with accountants on accounting or financial disclosure matters - No changes in or disagreements with accountants on accounting and financial disclosure were reported[699](index=699&type=chunk) [Item 9A. Controls and Procedures](index=122&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the effectiveness of the company's disclosure controls and procedures as of December 31, 2023, concluding they were effective at a reasonable assurance level. No material changes in internal control over financial reporting were identified during the quarter, and management concluded that internal control over financial reporting was effective as of December 31, 2023 - As of December 31, 2023, the company's disclosure controls and procedures were evaluated and deemed **effective** at the reasonable assurance level by management, including the CEO and CFO[699](index=699&type=chunk) - No material changes in internal control over financial reporting were identified during the quarter ended December 31, 2023[700](index=700&type=chunk) - Management concluded that the company's internal control over financial reporting was **effective** as of December 31, 2023, based on the COSO framework[701](index=701&type=chunk) [Item 9B. Other Information](index=123&type=section&id=Item%209B.%20Other%20Information) During the fiscal quarter ended December 31, 2023, no officers or directors adopted, modified, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements - No officers or directors adopted, modified, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the fiscal quarter ended December 31, 2023[704](index=704&type=chunk) [Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=123&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company - The company is not subject to disclosures regarding foreign jurisdictions that prevent inspections[705](index=705&type=chunk) PART III This part incorporates by reference information on corporate governance, executive compensation, security ownership, and auditor fees [Item 10. Directors, Executive Officers and Corporate Governance](index=123&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information regarding the company's directors, executive officers, and corporate governance, including Section 16(a) beneficial ownership reporting compliance, is incorporated by reference from the 2024 Proxy Statement - Information on directors, executive officers, corporate governance, and Section 16(a) beneficial ownership reporting compliance is incorporated by reference from the 2024 Proxy Statement[708](index=708&type=chunk) [Item 11. Executive Compensation](index=123&type=section&id=Item%2011.%20Executive%20Compensation) Information concerning executive and non-employee director compensation is incorporated by reference from the 2024 Proxy Statement - Information on executive compensation and non-employee director compensation is incorporated by reference from the 2024 Proxy Statement[708](index=708&type=chunk) [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=123&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Details regarding security ownership of certain beneficial owners and management, along with securities authorized for issuance under equity compensation plans, are incorporated by reference from the 2024 Proxy Statement - Information on security ownership of certain beneficial owners and management, and securities authorized for issuance under equity compensation plans, is incorporated by reference from the 2024 Proxy Statement[709](index=709&type=chunk) [Item 13. Certain Relationships and Related Transactions, and Director Independence](index=123&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information on certain relationships, related transactions, and director independence is incorporated by reference from the 2024 Proxy Statement - Information on certain relationships, related transactions, and director independence is incorporated by reference from the 2024 Proxy Statement[709](index=709&type=chunk) [Item 14. Principal Accountant Fees and Services](index=123&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Information regarding principal accountant fees and services is incorporated by reference from the 2024 Proxy Statement - Information on principal accountant fees and services is incorporated by reference from the 2024 Proxy Statement[710](index=710&type=chunk) PART IV This part lists financial statement schedules and exhibits, and includes the required corporate signatures for the report [Item 15. Exhibit and Financial Statement Schedules](index=124&type=section&id=Item%2015.%20Exhibit%20and%20Financial%20Statement%20Schedules) This section lists the financial statements and exhibits filed as part of the Annual Report on Form 10-K. It indicates that consolidated financial statements are presented in Part II, Item 8, and all financial schedules have been omitted as the information is either presented in the financial statements/notes or is not applicable. A comprehensive list of exhibits, including corporate documents, agreements, and certifications, is provided - Consolidated Financial Statements are listed in Part II, Item 8 of this Annual Report on Form 10-K[712](index=712&type=chunk) - All financial schedules are omitted because the required information is presented in the consolidated financial statements or notes, or is not applicable[713](index=713&type=chunk) - A comprehensive list of exhibits, including corporate documents, agreements, and certifications, is filed as part of this Annual Report or incorporated by reference[714](index=714&type=chunk) [Item 16. Form 10-K Summary](index=127&type=section&id=Item%2016.%20Form%2010-K%20Summary) This item is not applicable to the company - The company is not providing a Form 10-K Summary[719](index=719&type=chunk) [Signatures](index=128&type=section&id=Signatures) This section contains the required signatures for the Annual Report on Form 10-K, including those of the President and Chief Executive Officer, Chief Financial Officer, and members of the Board of Directors, affirming their authorization and compliance with the Securities Exchange Act of 1934 - The Annual Report on Form 10-K is duly signed by the President and Chief Executive Officer, Chief Financial Officer, and members of the Board of Directors, as required by Section 13 or 15(d) of the Securities Exchange Act of 1934[722](index=722&type=chunk)[724](index=724&type=chunk)[725](index=725&type=chunk)[726](index=726&type=chunk)

Exhibit 99.1 GERMANTOWN, MD, February 29, 2024 —Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today reported financial results for the quarter and full year ended December 31, 2023. SENSEONICS HOLDINGS, INC. REPORTS FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS Recent Highlights & Accomplishments: "2023 was a successful year across ...

Senseonics Holdings, Inc. (NYSE:SENS) Q3 2023 Earnings Call Transcript November 9, 2023 4:30 PM ET Company Participants Trip Taylor - IR Tim Goodnow - President and CEO Rick Sullivan - CFO Mukul Jain - COO Conference Call Participants Marie Thibault - BTIG Jayson Bedford - Raymond James Operator Good day and welcome to the Senseonics Third Quarter 2023 Earnings Conference Call. All participants will be in listen-only mode. [Operator Instructions] Please note today's event is being recorded. I would now like ...