Senseonics(SENS) - 2022 Q2 - Quarterly Report

PART I: Financial Information ITEM 1: Financial Statements This section presents the unaudited condensed consolidated financial statements, including the Balance Sheets, Statements of Operations and Comprehensive Income (Loss), Statements of Changes in Stockholders' Equity (Deficit), Statements of Cash Flows, and accompanying notes, providing a detailed financial overview for the periods ended June 30, 2022, and December 31, 2021 Condensed Consolidated Balance Sheets The balance sheet shows a decrease in total assets from $198.9 million at December 31, 2021, to $175.3 million at June 30, 2022, primarily due to a reduction in long-term investments and derivative liabilities. Total liabilities significantly decreased from $384.5 million to $159.4 million, while stockholders' equity shifted from a deficit of $185.5 million to a positive $15.9 million | Metric | Dec 31, 2021 (in thousands) | Jun 30, 2022 (in thousands) | Change (in thousands) | | :----------------------------- | :-------------------------- | :-------------------------- | :-------------------- | | Total Assets | $198,928 | $175,325 | $(23,603) | | Total Liabilities | $384,463 | $159,384 | $(225,079) | | Total Stockholders' Equity (Deficit) | $(185,535) | $15,941 | $201,476 | Unaudited Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) For the three months ended June 30, 2022, the company reported a net income of $104.2 million, a significant improvement from a net loss of $180.3 million in the prior year, driven by substantial gains on fair value adjustments of options and derivatives. Total revenue increased slightly to $3.7 million from $3.3 million. For the six months ended June 30, 2022, net income was $190.9 million, compared to a net loss of $429.8 million in 2021, with total revenue remaining consistent at $6.2 million | Metric (in thousands) | 3 Months Ended Jun 30, 2022 | 3 Months Ended Jun 30, 2021 | Change | | :-------------------- | :-------------------------- | :-------------------------- | :----- | | Total Revenue | $3,714 | $3,289 | $425 | | Gross Profit | $824 | $392 | $432 | | Operating Loss | $(17,036) | $(15,890) | $(1,146)| | Net Income (Loss) | $104,231 | $(180,306) | $284,537| | Basic EPS | $0.22 | $(0.42) | $0.64 | | Diluted EPS | $(0.03) | $(0.42) | $0.39 | | Metric (in thousands) | 6 Months Ended Jun 30, 2022 | 6 Months Ended Jun 30, 2021 | Change | | :-------------------- | :-------------------------- | :-------------------------- | :----- | | Total Revenue | $6,196 | $6,135 | $61 | | Gross Profit | $1,351 | $918 | $433 | | Operating Loss | $(32,197) | $(27,206) | $(4,991)| | Net Income (Loss) | $190,949 | $(429,820) | $620,769| | Basic EPS | $0.42 | $(1.08) | $1.50 | | Diluted EPS | $(0.06) | $(1.08) | $1.02 | Unaudited Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit) The company's total stockholders' equity (deficit) significantly improved from a deficit of $185.5 million at December 31, 2021, to a positive $15.9 million at June 30, 2022. This change was primarily driven by a net income of $190.9 million and an increase in additional paid-in capital from common stock issuances and stock-based compensation, partially offset by other comprehensive losses | Metric (in thousands) | Dec 31, 2021 | Jun 30, 2022 | Change | | :-------------------- | :----------- | :----------- | :----- | | Common Stock | $447 | $465 | $18 | | Additional Paid-In Capital | $765,215 | $776,640 | $11,425| | Accumulated Deficit | $(950,985) | $(760,036) | $190,949| | Total Stockholders' Equity (Deficit) | $(185,535) | $15,941 | $201,476| Unaudited Condensed Consolidated Statements of Cash Flows For the six months ended June 30, 2022, net cash used in operating activities was $34.3 million, an increase from $30.4 million in the prior year. Investing activities provided $42.1 million in cash, a significant shift from $145.3 million used in 2021, primarily due to marketable securities sales. Financing activities provided $4.2 million, a substantial decrease from $227.3 million in 2021, mainly due to lower common stock issuances. Overall, cash and cash equivalents increased by $12.0 million to $45.4 million | Cash Flow Activity (in thousands) | 6 Months Ended Jun 30, 2022 | 6 Months Ended Jun 30, 2021 | Change | | :-------------------------------- | :-------------------------- | :-------------------------- | :----- | | Net cash used in operating activities | $(34,341) | $(30,407) | $(3,934)| | Net cash provided by (used in) investing activities | $42,108 | $(145,318) | $187,426| | Net cash provided by financing activities | $4,197 | $227,274 | $(223,077)| | Net increase in cash and cash equivalents | $11,964 | $51,549 | $(39,585)| | Cash and cash equivalents, at ending of period | $45,425 | $69,754 | $(24,329)| Notes to Unaudited Condensed Consolidated Financial Statements These notes provide detailed disclosures on the company's financial position, operations, and cash flows, covering significant accounting policies, liquidity, revenue recognition, debt, equity, and fair value measurements. Key updates include capital raising activities, changes in derivative valuations, and the repayment of the PPP Loan Note 1. Organization and Nature of Operations Senseonics Holdings, Inc. is a medical technology company specializing in long-term, implantable continuous glucose monitoring (CGM) systems - Senseonics Holdings, Inc. is a medical technology company specializing in long-term, implantable continuous glucose monitoring (CGM) systems[15] Note 2. Liquidity and Capital Resources The company has an accumulated deficit of $760.0 million and $150.5 million in cash and marketable securities as of June 30, 2022, having raised $8.0 million from common stock sales - The Company has an accumulated deficit of $760.0 million as of June 30, 2022, and has never been profitable from operations[17] - As of June 30, 2022, the Company had $150.5 million in cash, cash equivalents, and marketable securities[17] - During the six months ended June 30, 2022, the Company received $8.0 million in net proceeds from the sale of 3,077,493 shares of common stock under the 2021 Sales Agreement[18] Note 3. Summary of Significant Accounting Policies The company's financial statements adhere to U.S. GAAP, with management estimates impacting reported amounts, and operates as a single segment focused on glucose monitoring products - The Company's financial statements are prepared under U.S. GAAP for interim reporting, with management's estimates affecting various reported amounts[25][31] - The Company operates as a single segment focused on glucose monitoring products[26] - Adoption of ASU 2020-06 on January 1, 2022, had no material impact; ASU 2016-13 (effective Jan 1, 2023) is not expected to have a significant impact[28][30] Note 4. Revenue Recognition Revenue is primarily generated from Eversense system sales to Ascensia and other partners, with the majority of revenue coming from outside the United States - Revenue is generated from sales of the Eversense system to Ascensia, EU distributors, and US strategic fulfillment partners[34] | Customer | 3 Months Ended Jun 30, 2022 | 3 Months Ended Jun 30, 2021 | 6 Months Ended Jun 30, 2022 | 6 Months Ended Jun 30, 2021 | | :------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Ascensia Revenue % | 96% | 87% | 93% | 85% | | Geographic Region (in thousands) | 3 Months Ended Jun 30, 2022 | 3 Months Ended Jun 30, 2021 | 6 Months Ended Jun 30, 2022 | 6 Months Ended Jun 30, 2021 | | :------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Outside of the United States | $2,507 (67.5%) | $2,310 (70.2%) | $4,222 (68.1%) | $4,843 (78.9%) | | United States | $1,207 (32.5%) | $979 (29.8%) | $1,974 (31.9%) | $1,292 (21.1%) | | Total Revenue | $3,714 | $3,289 | $6,196 | $6,135 | Note 5. Net Income (Loss) per Share Basic EPS for the six months ended June 30, 2022, was $0.42, while diluted EPS was $(0.06), with potentially dilutive shares excluded during net loss periods | Metric | 3 Months Ended Jun 30, 2022 | 3 Months Ended Jun 30, 2021 | 6 Months Ended Jun 30, 2022 | 6 Months Ended Jun 30, 2021 | | :----- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Basic EPS | $0.22 | $(0.42) | $0.42 | $(1.08) | | Diluted EPS | $(0.03) | $(0.42) | $(0.06) | $(1.08) | - Potentially dilutive common shares are excluded from diluted EPS calculations during net loss periods as they would be anti-dilutive[39][41] Note 6. Marketable Securities Total marketable securities decreased by $43.2 million to $105.1 million at June 30, 2022, with unrealized losses primarily due to interest rate fluctuations | Security Type (in thousands) | Dec 31, 2021 Market Value | Jun 30, 2022 Market Value | Change | | :--------------------------- | :------------------------ | :------------------------ | :----- | | Commercial Paper | $57,369 | $14,532 | $(42,837)| | Corporate Debt Securities | $39,748 | $36,897 | $(2,851)| | Asset Backed Securities | $26,707 | $14,734 | $(11,973)| | Government and Agency Securities | $24,503 | $38,929 | $14,426| | Total Marketable Securities | $148,327 | $105,092 | $(43,235)| - Unrealized losses of $1.1 million at June 30, 2022, were primarily due to interest rate fluctuations, not increased credit risk[42][43] Note 7. Inventory, net Total inventory increased by $0.9 million to $7.3 million at June 30, 2022, with a $0.6 million charge for obsolete/excess inventory recorded in Q2 and H1 2022 | Inventory Category (in thousands) | Dec 31, 2021 | Jun 30, 2022 | Change | | :-------------------------------- | :----------- | :----------- | :----- | | Finished goods | $1,012 | $1,020 | $8 | | Work-in-process | $3,770 | $4,705 | $935 | | Raw materials | $1,534 | $1,526 | $(8) | | Total | $6,316 | $7,251 | $935 | - A $0.6 million charge was recorded to cost of sales for obsolete/excess inventory in Q2 and H1 2022, compared to no charge in 2021[44] Note 8. Prepaid Expenses, Other Current Assets, and Deposits and other assets Total prepaid and other current assets increased by $1.6 million to $7.8 million, and deposits and other assets increased by $2.2 million due to a lease extension | Category (in thousands) | Dec 31, 2021 | Jun 30, 2022 | Change | | :---------------------- | :----------- | :----------- | :----- | | Contract manufacturing | $5,036 | $5,314 | $278 | | Insurance | $74 | $913 | $839 | | Clinical and Preclinical| $142 | $669 | $527 | | Total Prepaid & Other Current Assets | $6,218 | $7,818 | $1,600 | - Deposits and other assets increased by $2.2 million, primarily due to a $3.2 million right-of-use asset from a five-year lease extension for corporate headquarters[45] Note 9. Accrued Expenses, Other Current Liabilities, and Other Liabilities Total accrued expenses and other current liabilities increased slightly to $14.4 million, while other liabilities increased to $3.1 million due to a non-current operating lease liability | Category (in thousands) | Dec 31, 2021 | Jun 30, 2022 | Change | | :---------------------- | :----------- | :----------- | :----- | | Compensation and benefits | $3,484 | $3,251 | $(233) | | Research and development | $2,145 | $2,254 | $109 | | Sales and marketing services | $1,962 | $2,276 | $314 | | Total Accrued Expenses & Other Current Liabilities | $14,264 | $14,423 | $159 | - Other liabilities increased from $0.6 million to $3.1 million due to the non-current portion of the operating lease liability after a five-year extension[46] Note 10. Product Warranty Obligations The product warranty reserve increased from $0.7 million to $0.8 million from December 31, 2021, to June 30, 2022 - The warranty reserve increased from $0.7 million to $0.8 million from December 31, 2021, to June 30, 2022[48] | Warranty Activity (in thousands) | 6 Months Ended Jun 30, 2022 | 12 Months Ended Dec 31, 2021 | | :------------------------------- | :-------------------------- | :--------------------------- | | Balance at beginning of period | $723 | $646 | | Provision for warranties | $47 | $781 | | Settlements made | $(6) | $(704) | | Balance at end of period | $764 | $723 | Note 11. Notes Payable, Preferred Stock and Stock Purchase Warrants The company repaid its $5.8 million PPP Loan in April 2022, and outstanding convertible notes include $15.7 million for 2023 Notes, $51.2 million for 2025 Notes, and $35.0 million for PHC Notes - The $5.8 million PPP Loan was fully repaid in April 2022[50] | Note Type | Principal (in thousands) as of Jun 30, 2022 | Maturity Date | Interest Rate | | :-------- | :---------------------------------------- | :------------ | :------------ | | 2023 Notes | $15,700 | Feb 1, 2023 | 5.25% | | 2025 Notes | $51,199 | Jan 15, 2025 | 5.25% | | PHC Notes | $35,000 | Oct 31, 2024 | 8.00% (decreased from 9.5%) | - The fair value of the Energy Capital Option liability decreased from $69.4 million to $19.5 million, and the PHC Option asset increased from $0.2 million to $1.1 million[52][61] Note 12. Stockholders' Equity (Deficit) The company received $8.0 million in net proceeds from common stock sales in H1 2022, following significant capital raises in H1 2021 - $8.0 million in net proceeds were received from the sale of 3,077,493 common shares under the 2021 Sales Agreement during H1 2022[74] - In H1 2021, the company raised $48.4 million from the 2019 Sales Agreement, $106.1 million from the 2021 Public Offering, and $46.1 million from the Registered Direct Offering[75][76] Note 13. Stock-Based Compensation As of June 30, 2022, 19.7 million shares were available for grant under the 2015 Plan, with 28,944 shares purchased under the 2016 ESPP during H1 2022 - As of June 30, 2022, 19.7 million shares were available for grant under the 2015 Plan, 0.8 million under the Inducement Plan, and 13.1 million under the 2016 ESPP[78][79][80] - 28,944 shares of common stock were purchased under the 2016 ESPP during the six months ended June 30, 2022[80] Note 14. Fair Value Measurements Total Level 3 instruments decreased by $158.9 million to $65.2 million, driven by significant gains on fair value adjustments of options and derivatives | Level 3 Instruments (in thousands) | Dec 31, 2021 | Jun 30, 2022 | Change | | :--------------------------------- | :----------- | :----------- | :----- | | Total Level 3 Instruments | $224,037 | $65,151 | $(158,886)| - The decrease in Level 3 instruments was driven by a $49.9 million gain on fair value adjustment of option and a $107.7 million gain on change in fair value of derivatives[86] Note 15. Income Taxes No tax provision or benefit was recorded for H1 2022 or H1 2021 due to a full valuation allowance on net deferred tax assets - No tax provision or benefit was recorded for H1 2022 or H1 2021 due to a full valuation allowance on net deferred tax assets[87] Note 16. Related Party Transactions Revenue from Ascensia, a related party, increased to $5.7 million in H1 2022, with balances due from and to Ascensia also increasing - Revenue from Ascensia, a related party, increased to $5.7 million in H1 2022 from $5.2 million in H1 2021[89] | Related Party Balances (in thousands) | Dec 31, 2021 | Jun 30, 2022 | Change | | :------------------------------------ | :----------- | :----------- | :----- | | Due from Ascensia | $1,800 | $4,300 | $2,500 | | Due to Ascensia | $2,500 | $3,600 | $1,100 | Note 17. Subsequent Events No subsequent events requiring financial statement adjustments or disclosures were identified through the filing date - No subsequent events requiring financial statement adjustments or disclosures were identified through the filing date[91] ITEM 2: Management Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial condition and results of operations, highlighting the commercialization progress of Eversense CGM systems, financial performance for the three and six months ended June 30, 2022, and an assessment of liquidity and capital resources Overview Senseonics is a medical technology company focused on long-term implantable continuous glucose monitoring (CGM) systems, including Eversense, Eversense XL, and Eversense E3. The Eversense E3 system, with a six-month sensor life, received CE mark in June 2022 and FDA approval in February 2022, with commercialization by Ascensia beginning in Q2 2022 in the US and Q3 2022 in Europe. The company has achieved approximately 250 million covered lives in the U.S. through positive insurance payor coverage decisions - Senseonics develops and manufactures long-term implantable CGM systems (Eversense, Eversense XL, Eversense E3) for diabetes management[94] - Eversense E3, offering a six-month sensor life, received FDA approval in February 2022 and CE mark in June 2022, with commercialization by Ascensia in the US (Q2 2022) and Europe (Q3 2022)[94][110] - The company has secured coverage for approximately 250 million lives in the U.S. through positive insurance payor decisions[96] United States Development and Commercialization of Eversense The Eversense CGM system received FDA PMA approval for 90-day use in June 2018, and the 180-day Eversense E3 system was FDA approved in February 2022 and commercialized by Ascensia in Q2 2022. A clinical trial for a 365-day sensor is planned for the second half of 2022 - Eversense CGM received FDA PMA approval for 90-day use in June 2018 and non-adjunctive indication in June 2019[101][103] - The 180-day Eversense E3 CGM system was FDA approved in February 2022 and commercialization by Ascensia began in Q2 2022[102][107] - A clinical trial for a 365-day sensor, including a pediatric population, is targeted for enrollment in the second half of 2022[104] European Commercialization of Eversense The Eversense XL CGM system received CE mark in September 2017 for 180-day sensor life, and the Eversense E3 system also received CE mark in June 2022, with European commercialization by Ascensia starting in Q3 2022 - Eversense XL received CE mark in September 2017 for 180-day sensor life and launched in Europe in Q4 2017[108] - Eversense E3 received CE mark in June 2022, with Ascensia commencing European commercialization in Q3 2022[110] Financial Overview (Revenue, Cost of Sales, Gross Profit) The company's revenue is primarily from sales of Eversense systems to distributors and partners, with Ascensia accounting for the majority. Revenue recognition occurs upon product control transfer, with variable consideration (discounts, revenue share) estimated and constrained. Contract assets include unbilled receivables from Ascensia's revenue share - Revenue is generated from Eversense system sales to Ascensia, EU distributors, and US strategic fulfillment partners, with Ascensia being the primary customer[111][115] - Revenue recognition is at the point of control transfer, with variable consideration (discounts, revenue share) estimated and constrained[112][113] - Contract assets consist of unbilled receivables from Ascensia's revenue share[114] Results of Operations for the Three Months Ended June 30, 2022 and 2021 Total revenue increased by $0.4 million to $3.7 million, gross profit more than doubled to $0.8 million with a 22.2% gross margin, and net income significantly improved to $104.2 million from a net loss of $180.3 million, driven by fair value adjustments | Metric (in thousands) | 3 Months Ended Jun 30, 2022 | 3 Months Ended Jun 30, 2021 | Change | | :-------------------- | :-------------------------- | :-------------------------- | :----- | | Total Revenue | $3,714 | $3,289 | $425 | | Cost of Sales | $2,891 | $2,897 | $(6) | | Gross Profit | $824 | $392 | $432 | | Gross Margin | 22.2% | 11.9% | 10.3 pp| | R&D Expenses | $9,299 | $7,107 | $2,192 | | SG&A Expenses | $8,561 | $9,175 | $(614) | | Operating Loss | $(17,036) | $(15,890) | $(1,146)| | Total Other Income (Expense), net | $121,267 | $(164,416) | $285,683| | Net Income (Loss) | $104,231 | $(180,306) | $284,537| - Gross margin improved significantly due to the utilization of previously written-off inventory and a favorable sales mix[121] - R&D expenses increased by $2.2 million due to investments in next-generation technologies, clinical studies, and workforce expansion[122] Results of Operations for the Six Months Ended June 30, 2022 and 2021 Total revenue remained consistent at $6.2 million, gross profit increased to $1.4 million with a 21.8% gross margin, and net income significantly improved to $190.9 million from a net loss of $429.8 million, driven by fair value adjustments | Metric (in thousands) | 6 Months Ended Jun 30, 2022 | 6 Months Ended Jun 30, 2021 | Change | | :-------------------- | :-------------------------- | :-------------------------- | :----- | | Total Revenue | $6,196 | $6,135 | $61 | | Cost of Sales | $4,845 | $5,217 | $(372) | | Gross Profit | $1,351 | $918 | $433 | | Gross Margin | 21.8% | 15.0% | 6.8 pp | | R&D Expenses | $17,103 | $12,362 | $4,741 | | SG&A Expenses | $16,445 | $15,762 | $683 | | Operating Loss | $(32,197) | $(27,206) | $(4,991)| | Total Other Income (Expense), net | $223,146 | $(402,614) | $625,760| | Net Income (Loss) | $190,949 | $(429,820) | $620,769| - R&D expenses increased by $4.7 million due to investments in next-generation technologies, clinical studies, personnel, and consulting services[129] - SG&A expenses increased by $0.6 million due to higher general and administrative costs, partially offset by lower sales and marketing costs as Ascensia assumed commercialization[130] Liquidity and Capital Resources The company has an accumulated deficit of $760.0 million and $150.5 million in cash and marketable securities as of June 30, 2022, with management expecting existing liquidity to be sufficient through 2023 - Accumulated deficit was $760.0 million as of June 30, 2022, with no historical profitability from operations[132] - Cash, cash equivalents, and marketable debt securities totaled $150.5 million as of June 30, 2022[132] - Management expects existing liquidity to be sufficient through 2023 and may seek additional capital for strategic flexibility[143][159] Indebtedness The company repaid its $5.8 million PPP Loan in April 2022, with outstanding convertible notes including $15.7 million for 2023 Notes, $51.2 million for 2025 Notes, and $35.0 million for PHC Notes, whose interest rate decreased to 8.0% in April 2022 - The $5.8 million PPP Loan was fully repaid in April 2022[147] | Convertible Note | Principal (in millions) as of Jun 30, 2022 | Maturity Date | Coupon Rate | | :--------------- | :--------------------------------------- | :------------ | :---------- | | 2023 Notes | $15.7 | Feb 1, 2023 | 5.25% | | 2025 Notes | $51.2 | Jan 15, 2025 | 5.25% | | PHC Notes | $35.0 | Oct 31, 2024 | 8.00% | - The interest rate on PHC Notes decreased to 8.0% in April 2022 due to FDA approval of the 180-day Eversense E3 product[152] Funding Requirements and Outlook Future profitability depends on successful commercialization and adoption of Eversense CGM systems, requiring significant working capital through 2022 and beyond for product development and expanding insurance coverage, with existing cash expected to cover needs through 2023 - Future profitability hinges on successful commercialization, adoption, product development, and regulatory approvals of Eversense CGM systems[157] - Significant working capital is required through 2022 and beyond for activities like expanding insurance coverage and developing the Eversense 365-day product[157] - Existing cash and future operations are expected to cover operating needs through 2023, with potential for additional capital market access[159] Cash Flows Net cash used in operating activities increased to $34.3 million, investing activities provided $42.1 million, a significant positive swing, and financing activities decreased substantially to $4.2 million due to lower common stock issuances | Cash Flow Activity (in thousands) | 6 Months Ended Jun 30, 2022 | 6 Months Ended Jun 30, 2021 | Change | | :-------------------------------- | :-------------------------- | :-------------------------- | :----- | | Net cash used in operating activities | $(34,341) | $(30,407) | $(3,934)| | Net cash provided by (used in) investing activities | $42,108 | $(145,318) | $187,426| | Net cash provided by financing activities | $4,197 | $227,274 | $(223,077)| - Investing activities shifted from a significant cash outflow in 2021 to a substantial inflow in 2022, driven by marketable securities sales[164] - Financing cash flow decreased significantly due to reduced common stock issuances compared to the prior year[165][166] Contractual Obligations No material changes in contractual obligations and commitments were reported as of June 30, 2022, compared to the prior Annual Report on Form 10-K - No material changes in contractual obligations and commitments were reported as of June 30, 2022, compared to the prior Annual Report on Form 10-K[167] ITEM 3: Quantitative and Qualitative Disclosures about Market Risk As a "smaller reporting company" under SEC rules, Senseonics Holdings, Inc. is not required to provide quantitative and qualitative disclosures about market risk in this Quarterly Report on Form 10-Q - The company is exempt from providing market risk disclosures in this 10-Q due to its status as a "smaller reporting company"[168] ITEM 4: Controls and Procedures Management evaluated the effectiveness of disclosure controls and procedures as of June 30, 2022, concluding they were effective, with no material changes in internal control over financial reporting during the quarter - Disclosure controls and procedures were deemed effective at a reasonable assurance level as of June 30, 2022[169] - No material changes in internal control over financial reporting occurred during Q2 2022[170] PART II: Other Information ITEM 1: Legal Proceedings The company faces ongoing litigation, including an amended False Claims Act complaint filed in May 2022, and was assessed a EUR 45,000 fine by the Italian Data Protection Authority for GDPR breaches, which it intends to settle for EUR 22,500 - A False Claims Act civil complaint was dismissed without prejudice on March 31, 2022, but an amended complaint was filed on May 27, 2022, to which the company filed another motion to dismiss on July 11, 2022[173][175] - The Italian Data Protection Authority (Garante) found GDPR breaches, assessing a EUR 45,000 fine, which the company intends to settle for EUR 22,500 by updating its privacy notice and not appealing[176] ITEM 1A: Risk Factors Risk factors remain consistent with the Annual Report on Form 10-K, with new emphasis on the potential negative impact of the Russia-Ukraine conflict and macroeconomic conditions like inflation and rising interest rates - Risk factors remain largely consistent with the Annual Report on Form 10-K, with new emphasis on the Russia-Ukraine conflict[177] - The Russia-Ukraine military action could adversely affect the global economy, the company's business, operations, and financial condition, including supply chains and capital raising[178][179] - Economic downturns, inflation, and rising interest rates are identified as macroeconomic conditions that could negatively impact the business and financial performance[180][181] ITEM 2: Unregistered Sales of Equity and Securities and Use of Proceeds This item is not applicable to the company for this reporting period - Not applicable for this reporting period[182] ITEM 3: Defaults Upon Senior Securities This item is not applicable to the company for this reporting period - Not applicable for this reporting period[183] ITEM 4: Mine Safety Disclosures This item is not applicable to the company for this reporting period - Not applicable for this reporting period[184] ITEM 5: Other Information No other information is reported under this item for the current period - No other information to report[185] ITEM 6: Exhibits This section lists the exhibits filed or incorporated by reference as part of this Quarterly Report on Form 10-Q, including corporate governance documents, agreements, and certifications - Lists exhibits filed or incorporated by reference, including corporate documents, agreements, and certifications[186][187] SIGNATURES The report is duly signed on behalf of Senseonics Holdings, Inc. by Nick B. Tressler, Chief Financial Officer, on August 9, 2022 - Report signed by Nick B. Tressler, CFO, on August 9, 2022[193]