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Senseonics(SENS) - 2020 Q1 - Quarterly Report

PART I: Financial Information This section presents the Company's unaudited condensed consolidated financial statements and management's discussion for Q1 2020 ITEM 1: Financial Statements This section presents the unaudited condensed consolidated financial statements for Q1 2020, including balance sheets, statements of operations, cash flows, and detailed notes Condensed Consolidated Balance Sheets This section provides a snapshot of the Company's financial position, detailing assets, liabilities, and stockholders' deficit as of March 31, 2020 Condensed Consolidated Balance Sheets (in thousands) | Metric | March 31, 2020 (Unaudited) | December 31, 2019 | | :-------------------------------- | :-------------------------- | :------------------ | | Cash and cash equivalents | $18,605 | $95,938 | | Total current assets | $30,536 | $127,758 | | Total assets | $35,269 | $132,801 | | Total current liabilities | $17,861 | $126,708 | | Total liabilities | $84,230 | $141,450 | | Total stockholders' deficit | $(48,961) | $(8,649) | Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss This section outlines the Company's financial performance, including revenue, cost of sales, gross profit, and net loss for Q1 2020 and 2019 Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss (in thousands) | Metric | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :-------------------------- | :-------------------------------- | :-------------------------------- | | Total revenue | $36 | $3,423 | | Cost of sales | $19,670 | $6,733 | | Gross profit | $(19,634) | $(3,310) | | Operating loss | $(43,831) | $(29,768) | | Net loss | $(42,593) | $(29,365) | | Basic and diluted net loss per common share | $(0.21) | $(0.17) | - Total revenue decreased significantly by $3,387 thousand (99%) from $3,423 thousand in Q1 2019 to $36 thousand in Q1 2020, primarily due to deferral of sales orders by Roche and COVID-19 related concessions17152 - Cost of sales increased by $12,937 thousand (192%) to $19,670 thousand in Q1 2020, mainly due to $16.3 million in inventory impairment charges, scrap, and write-offs17153 - Net loss widened to $(42,593) thousand in Q1 2020 from $(29,365) thousand in Q1 2019, an increase of $13,228 thousand17151 Unaudited Condensed Consolidated Statements of Changes in Stockholders' Equity (Deficit) This section details changes in the Company's equity and accumulated deficit between December 31, 2019, and March 31, 2020 Changes in Stockholders' Equity (Deficit) (in thousands) | Metric | Balance, December 31, 2019 | Balance, March 31, 2020 | | :-------------------------- | :------------------------- | :---------------------- | | Common Stock Amount | $203 | $204 | | Additional Paid-In Capital | $464,491 | $466,771 | | Accumulated Deficit | $(473,343) | $(515,936) | | Total Stockholders' Equity (Deficit) | $(8,649) | $(48,961) | - The accumulated deficit increased by $42,593 thousand to $(515,936) thousand as of March 31, 2020, primarily due to the net loss incurred during the quarter20 Unaudited Condensed Consolidated Statements of Cash Flows This section presents the Company's cash inflows and outflows from operating, investing, and financing activities for Q1 2020 and 2019 Unaudited Condensed Consolidated Statements of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :-------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(29,048) | $(30,152) | | Net cash used in investing activities | $(100) | $(490) | | Net cash used in financing activities | $(47,985) | $(2,476) | | Net decrease in cash, cash equivalents and restricted cash | $(77,133) | $(33,118) | | Cash, cash equivalents and restricted cash, at ending of period | $18,805 | $103,675 | - Net cash used in financing activities significantly increased to $47.985 million in Q1 2020 from $2.476 million in Q1 2019, primarily due to the $48.5 million repayment of the Solar Term Loan22195 - The company experienced a net decrease in cash, cash equivalents, and restricted cash of $77.133 million in Q1 2020, resulting in an ending balance of $18.805 million22 Notes to Unaudited Condensed Consolidated Financial Statements This section provides detailed explanations and disclosures supporting the unaudited condensed consolidated financial statements 1. Organization and Nature of Operations This note describes Senseonics Holdings, Inc. as a medical technology company focused on continuous glucose monitoring systems - Senseonics Holdings, Inc. is a medical technology company focused on developing and commercializing long-term, implantable continuous glucose monitoring (CGM) systems for diabetes management24 2. Going Concern and Liquidity Update This note addresses the Company's substantial operating losses, liquidity challenges, and management's doubt about its ability to continue as a going concern - The Company has incurred substantial operating losses since inception, with a net loss of $42.6 million for Q1 2020 and an accumulated deficit of $515.9 million2627 - Following the repayment of a $48.5 million term loan, the Company had $18.8 million in cash, cash equivalents, and restricted cash as of March 31, 202027 - Management has substantial doubt about the Company's ability to continue as a going concern for the next twelve months due to limited cash resources, the impact of COVID-19, and the need for additional financing29 - In response to liquidity concerns and COVID-19, the Company reduced its workforce by approximately 60% and temporarily suspended commercial sales of the Eversense CGM system in the U.S. to new patients, focusing on existing users and Eversense XL development27 3. Summary of Significant Accounting Policies This note outlines the key accounting principles and policies used in preparing the financial statements, including revenue recognition and recent pronouncements - The financial statements are prepared in accordance with U.S. GAAP for interim information, with certain disclosures condensed or omitted as permitted by SEC rules31 - The Company operates and manages its business as a single segment: glucose monitoring products34 - Revenue is recognized when customers obtain control of the product, with variable consideration (e.g., Eversense Bridge Program reimbursements) treated as a reduction in revenue4344 - The Company recorded a $0.2 million loss on disposal of property and equipment for Q1 2020 due to COVID-19 impacts on asset recoverability39 Recent Accounting Pronouncements This section details the adoption and evaluation of recent accounting standards updates and their expected impact on the Company's financial reporting - The Company adopted ASU 2018-13 (Fair Value Measurement) on January 1, 2020, with no material impact55 - The Company will adopt ASU 2016-13 (Credit Losses) on January 1, 2023, and does not expect a significant impact due to no historical collection issues56 - The Company is evaluating the impact of ASU 2019-12 (Simplifying Income Taxes), effective for fiscal years beginning after December 15, 202057 4. Inventory, net This note provides a breakdown of inventory components and discusses significant impairment charges recorded during the quarter Inventory, net (in thousands) | Category | March 31, 2020 | December 31, 2019 | | :-------------- | :------------- | :---------------- | | Finished goods | $1,043 | $3,944 | | Work-in-process | $1,282 | $10,938 | | Raw materials | $2,670 | $2,047 | | Total | $4,995 | $16,929 | - The Company charged $15.0 million to cost of sales for Q1 2020 to reduce inventory value due to potential obsolescence, excess demand, or net realizable value adjustments, compared to $0.1 million in Q1 201958 5. Prepaid Expenses and Other Current Assets This note details the composition of prepaid expenses and other current assets as of March 31, 2020, and December 31, 2019 Prepaid Expenses and Other Current Assets (in thousands) | Category | March 31, 2020 | December 31, 2019 | | :-------------------- | :------------- | :---------------- | | Contract manufacturing| $3,723 | $3,043 | | Insurance | $1,040 | $44 | | Marketing and sales | $534 | $605 | | Total | $5,740 | $4,512 | 6. Accrued Expenses and Other Current Liabilities This note outlines the Company's accrued expenses and other current liabilities, including those related to compensation and contract manufacturing Accrued Expenses and Other Current Liabilities (in thousands) | Category | March 31, 2020 | December 31, 2019 | | :---------------------------- | :------------- | :---------------- | | Compensation and benefits | $3,496 | $5,630 | | Contract manufacturing | $3,274 | $2,452 | | Product warranty and replacement obligations | $2,157 | $2,197 | | Total | $15,371 | $18,636 | - Accrued expenses include $1.6 million for one-time employee termination benefits due to the workforce reduction on March 26, 202062 7. Notes Payable and Stock Purchase Warrants This note details the Company's debt obligations, including the repayment of the Solar Term Loan and outstanding convertible notes - On March 22, 2020, the Company terminated its Loan and Security Agreement with Solar Capital Ltd. by repaying $48.5 million, resulting in a $4.5 million loss on extinguishment of debt636465 - The Company has $82.0 million in 2025 Notes (convertible at $1.32/share) and $15.7 million in 2023 Notes (convertible at $3.40/share) outstanding as of March 31, 2020676971 Interest Expense Related to Notes Payable (Three Months Ended March 31, 2020, in thousands) | Note Payable | Effective Interest Rate | Total Interest Expense ($) | | :---------------- | :---------------------- | :------------------------- | | Solar Term Loan | 8.98% | 1,302 | | 2023 Notes | 5.25% | 2,585 | | 2025 Notes | 5.25% | 482 | | Total | | 4,369 | 8. Stockholders' Deficit This note describes changes in stockholders' deficit, including common stock sales and the accumulated deficit - The Company sold 175,089 shares of common stock for $0.1 million in gross proceeds during Q1 2020 under its Open Market Sale Agreement with Jefferies LLC, which allows for up to $50 million in gross proceeds74 9. Stock‑Based Compensation This note provides information on the Company's equity incentive plans and shares available for grant or issuance - As of March 31, 2020, 17,261,319 shares remained available for grant under the 2015 Equity Incentive Plan76 - The Inducement Plan had 1,229,132 shares available for grant as of March 31, 2020, for inducement grants to new employees or directors77 - The 2016 Employee Stock Purchase Plan (ESPP) had 6,341,661 shares available for issuance, with 566,573 shares purchased on February 1, 20207879 10. Fair Value Measurements This note presents the fair value hierarchy for financial assets and liabilities, including money market funds, commercial paper, and embedded derivative features Fair Value Hierarchy of Financial Assets and Liabilities (March 31, 2020, in thousands) | Item | Total ($) | Level 1 ($) | Level 2 ($) | Level 3 ($) | | :--------------------------------- | :-------- | :---------- | :---------- | :---------- | | Assets | | | | | | Money market funds | 1,501 | 1,501 | — | — | | Commercial paper | 4,797 | — | 4,797 | — | | Liabilities | | | | | | Embedded features of the 2023 Notes| 336 | — | — | 336 | | Embedded features of the 2025 Notes| 15,560 | — | 15,560 | — | - The fair value of embedded features of the 2023 Notes, classified as Level 3, decreased from $664 thousand at December 31, 2019, to $336 thousand at March 31, 202083 11. Income Taxes This note discusses the Company's income tax provision, valuation allowance, and the impact of the CARES Act - The Company has not recorded any tax provision or benefit for Q1 2020 or Q1 2019 and maintains a full valuation allowance against its net deferred tax assets84 - The CARES Act, enacted March 27, 2020, did not result in any material adjustments to the Company's income tax provision or net deferred tax assets for Q1 20208586 12. Related Party Transactions This note details transactions with related parties, specifically revenue and amounts due from Roche - Revenue from Roche (a related party) decreased significantly from $2.2 million in Q1 2019 to less than $0.1 million in Q1 202087 - Amounts due from Roche decreased from $7.1 million at December 31, 2019, to less than $0.1 million at March 31, 202087 13. Subsequent Events This note describes significant events occurring after the balance sheet date, including new financing agreements and loan repayments - On April 22, 2020, the Company received a $5.8 million loan under the Paycheck Protection Program (PPP Loan) with a 1.0% annual interest rate and a two-year term, with potential for forgiveness based on specific criteria888990 - On April 21, 2020, the Company entered into a Loan and Security Agreement with Highbridge, securing up to $20.0 million in First Lien Notes (12-13% interest, due October 2021), receiving an initial $15.0 million tranche939495 - Also on April 21, 2020, the Company exchanged $24.0 million of its 2025 Notes for $15.7 million in newly issued Second Lien Notes (7.5-8.25% interest, due January 2022), 11,026,086 shares of common stock, and warrants to purchase 4,500,000 shares102103 - The Company is negotiating with suppliers and contract manufacturers for approximately $1.9 million in costs related to pausing manufacturing activities and an additional $0.6 million if certain timelines are not met109 ITEM 2: Management Discussion and Analysis of Financial Condition and Results of Operations Management discusses financial condition and results for Q1 2020, highlighting COVID-19 impacts, strategic shifts, new financings, and going concern issues Overview and Business Updates This section provides an overview of Senseonics' CGM systems, regulatory approvals, and clinical trial progress - Senseonics develops and commercializes Eversense and Eversense XL CGM systems, offering 90-day and 180-day implantable sensors, respectively, for diabetes management113 - The Eversense system received FDA approval in June 2018 and a non-adjunctive indication in June 2019, allowing it to replace fingerstick blood glucose measurements for treatment decisions114 - The PROMISE pivotal clinical trial for the 180-day Eversense XL in the U.S. completed patient visits in Q1 2020, with data expected to support an FDA submission in late summer 2020118 - In April 2020, Eversense XL received regulatory approval in Europe for MRI compatibility, a first for the CGM category119 Repayment of Solar Loan This section details the termination and repayment of the Loan and Security Agreement with Solar Capital Ltd. in March 2020 - The Company terminated its Loan and Security Agreement with Solar Capital Ltd. on March 22, 2020, by repaying $48.5 million, including principal, interest, and fees120121 - A $4.5 million loss on extinguishment of debt was recorded in Q1 2020 due to the Solar Loan repayment122 COVID-19 This section describes the significant adverse impacts of the COVID-19 pandemic on the Company's operations, revenue, and inventory - The COVID-19 pandemic led to significant disruptions, including stay-at-home orders, non-essential business closures in Maryland, and a reduction in access to clinics for sensor insertions124 - Net revenue for Q1 2020 was significantly lower than expected due to COVID-19, redistribution of government funding, excess distributor inventory, and Roche deferring sales orders125 - The Company impaired $15.0 million of inventory and related assets in Q1 2020 due to demand uncertainty and recorded a $0.2 million loss on disposal of long-lived assets126127 Streamlined Operational Focus This section outlines the Company's strategic shift, including temporary suspension of U.S. commercial sales and workforce reduction - The Company temporarily suspended commercial sales and marketing of Eversense in the U.S. to new patients, focusing resources on existing users and the Eversense XL regulatory submission129 - A workforce reduction of approximately 60% occurred on March 26, 2020, resulting in $1.6 million in one-time employee termination benefits129131 Exploring Strategic Alternatives This section discusses the Board of Directors' efforts to explore strategic alternatives and new financing sources to enhance stakeholder value - The Board of Directors is exploring potential strategic alternatives to enhance stakeholder value and is in discussions with new financing sources132 April 2020 Financings This section summarizes the new financing activities undertaken in April 2020, including the PPP Loan and secured notes - In April 2020, the Company secured $5.8 million from the PPP Loan, $15.0 million from First Lien Secured Notes with Highbridge, and exchanged $24.0 million of 2025 Notes for $15.7 million in Second Lien Secured Notes, common stock, and warrants133134135 Going Concern This section reiterates management's substantial doubt about the Company's ability to continue as a going concern due to liquidity challenges - Management has substantial doubt about the Company's ability to meet its obligations for the next twelve months, citing limited cash, subsequent financings, and COVID-19 uncertainty137 Financial Overview This section provides an overview of the Company's revenue generation, key customer contributions, and geographic sales distribution - Revenue is generated from sales of Eversense CGM systems to distributors, with recognition occurring upon transfer of control, subject to variable consideration like the Eversense Bridge Program138140141 - Revenue from Roche, a key customer, decreased from 59% of net revenues in Q1 2019 to less than 1% in Q1 2020143 Net Revenue by Geographic Region (in thousands) | Region | March 31, 2020 Amount | % of Total | March 31, 2019 Amount | % of Total | | :------------------------ | :-------------------- | :--------- | :-------------------- | :--------- | | Outside of the United States | $12 | 33.3% | $2,607 | 76.2% | | United States | $24 | 66.7% | $816 | 23.8% | | Total | $36 | 100.0% | $3,423 | 100.0% | - Accounts receivable were reduced by $1.2 million at March 31, 2020, due to one-time COVID-19 pandemic relief concessions to U.S. customers145 Results of Operations This section analyzes the Company's financial performance for Q1 2020 versus Q1 2019, detailing changes in revenue, expenses, and net loss Results of Operations (Three Months Ended March 31, 2020 vs. 2019, in thousands) | Metric | 2020 ($) | 2019 ($) | Period-to-Period Change ($) | | :-------------------------- | :--------- | :--------- | :-------------------------- | | Total revenue | 36 | 3,423 | (3,387) | | Cost of sales | 19,670 | 6,733 | 12,937 | | Gross profit | (19,634) | (3,310) | (16,324) | | Sales and marketing expenses| 11,145 | 12,834 | (1,689) | | Research and development expenses | 7,362 | 7,108 | 254 | | General and administrative expenses | 5,690 | 6,516 | (826) | | Operating loss | (43,831) | (29,768) | (14,063) | | Net loss | (42,593) | (29,365) | (13,228) | - Gross profit decreased by $16.3 million to $(19.6) million in Q1 2020, primarily due to lower sales, $16.3 million in inventory impairment charges, and COVID-19 relief concessions154 - Sales and marketing expenses decreased by $1.7 million, mainly due to lower consulting and travel expenses, partially offset by $0.7 million in severance costs156 - Total other income, net, increased by $0.8 million, driven by an $8.2 million increase in the change in fair value of derivative liabilities, partially offset by a $4.5 million loss on debt extinguishment and higher interest expense159 Liquidity and Capital Resources This section discusses the Company's historical losses, current cash position, and ongoing efforts to secure additional capital and strategic alternatives - The Company has never been profitable, with net losses of $42.6 million and $29.4 million for Q1 2020 and Q1 2019, respectively, and an accumulated deficit of $515.9 million as of March 31, 2020160 - As of March 31, 2020, cash, cash equivalents, and restricted cash totaled $18.8 million161 - The Company is actively pursuing strategic alternatives and new financing sources, including additional equity (via Jefferies agreement) or secured/unsecured indebtedness162163 Outstanding Senior Convertible Note Obligations (March 31, 2020) | Convertible Note | Issuance Date | Coupon | Aggregate Principal (in millions) | Maturity Date | | :--------------- | :------------ | :----- | :------------------------------ | :------------ | | 2023 Notes | January 2018 | 5.25% | $15.7 | February 1, 2023 | | 2025 Notes | July 2019 | 5.25% | $82.0 | January 15, 2025 | Funding Requirements and Outlook This section highlights management's concerns about future funding requirements and the potential consequences of failing to secure additional capital - Management has substantial doubt about the Company's ability to meet obligations for the next twelve months, emphasizing dependence on additional capital sources and favorable strategic alternatives188 - Failure to raise additional funds could lead to further delays, limitations, reductions, or termination of operating plans, and new financings may result in dilution or unfavorable terms188 Cash Flows This section provides a summary and analysis of cash flows from operating, investing, and financing activities for the reporting periods Summary of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2020 | Three Months Ended March 31, 2019 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(29,048) | $(30,152) | | Net cash used in investing activities | $(100) | $(490) | | Net cash used in financing activities | $(47,985) | $(2,476) | | Net decrease in cash, cash equivalents and restricted cash | $(77,133) | $(33,118) | - Net cash used in operating activities was $29.0 million in Q1 2020, driven by a $42.6 million net loss, partially offset by non-cash items like inventory charges and derivative fair value changes191 - Net cash used in financing activities was $48.0 million in Q1 2020, primarily due to the $45.0 million repayment of the Solar Loan and $3.4 million in associated fees195 Contractual Obligations This section details the Company's contractual obligations, including operating leases and principal and interest payments on notes payable Contractual Obligations as of March 31, 2020 (in thousands) | Contractual Obligations | Total ($) | Remainder of 2020 ($) | 2021-2022 ($) | 2023-2024 ($) | After 2024 ($) | | :---------------------------- | :-------- | :-------------------- | :------------ | :------------ | :------------- | | Operating lease obligations | 3,279 | 708 | 1,971 | 600 | - | | Principal payment under 2023 Notes | 15,700 | - | - | 15,700 | - | | Interest payments under 2023 Notes | 2,473 | 412 | 1,649 | 412 | - | | Principal payment under 2025 Notes | 82,000 | - | - | - | 82,000 | | Interest payments under 2025 Notes | 22,031 | 2,180 | 8,759 | 8,759 | 2,333 | | Other commitments | 1,500 | 1,500 | - | - | - | | Total contractual obligations | 126,983 | 4,800 | 12,379 | 25,471 | 84,333 | Off-Balance Sheet Arrangements This section confirms the absence of material off-balance sheet arrangements, aside from subsequent supplier commitments - The Company had no off-balance sheet arrangements as of March 31, 2020, other than subsequent supplier and contract manufacturer obligations198 - Subsequent to Q1 2020, the Company expects to pay approximately $1.9 million for costs related to pausing manufacturing and $0.6 million if certain manufacturing timelines are not met200 ITEM 3: Quantitative and Qualitative Disclosures about Market Risk This section details market risks, including interest rate and foreign currency exposure, and the potential impact of the COVID-19 pandemic - The Company's primary market risk exposure is interest rate sensitivity, but due to short-term cash equivalents and fixed interest rates on debt, a 100 basis point change would not materially affect fair value201 - Foreign currency risk primarily stems from Euro-denominated international sales, but transaction gains and losses have not been material to date202 - The COVID-19 pandemic has introduced significant volatility in financial markets, which could increase the Company's foreign currency and interest rate risk203 ITEM 4: Controls and Procedures This section covers disclosure controls and internal control over financial reporting, noting SEC rule changes and management's effectiveness conclusion - New SEC amendments waive the requirement for an independent auditor's attestation on internal control over financial reporting for smaller reporting companies, effective April 27, 2020, expected to result in material audit fee savings for 2020205206 - Management, with the assistance of the CEO and CFO, concluded that disclosure controls and procedures were effective at a reasonable assurance level as of March 31, 2020207 - There were no changes in internal control over financial reporting during Q1 2020 that materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting208 PART II: Other Information This section provides additional information not covered in the financial statements, including legal proceedings, risk factors, and exhibits ITEM 1: Legal Proceedings The Company is not currently involved in any material legal proceedings or aware of any threatened actions that could adversely affect its business - The Company is not currently involved in any material legal proceedings and is unaware of any pending or threatened legal actions that could materially impact its business209 ITEM 1A: Risk Factors This section updates risk factors, focusing on strategic alternatives, COVID-19 impacts, debt covenants, dilution, and PPP Loan forgiveness uncertainty - The Company is exploring strategic alternatives, but there is no assurance of success, and the process itself could adversely impact the business212 - The COVID-19 pandemic has adversely affected operations, including workforce productivity, clinic access, sensor insertions, and could disrupt the supply chain and clinical trials, with unknown long-term economic impacts214217220221222 - Restrictive covenants in debt agreements (2023 Notes, 2025 Notes, Highbridge Loan, Exchange Agreement) limit the Company's operational flexibility, including incurring additional debt, making investments, and asset transfers224 - Servicing substantial debt requires significant cash flow, which the Company may not generate, potentially forcing asset sales, debt restructuring, or dilutive equity capital225 - The issuance of additional common stock for financings, acquisitions, or convertible note conversions will dilute existing stockholders227 - There is uncertainty regarding the forgiveness of the $5.8 million PPP Loan, and potential adverse determinations could lead to penalties, repayment, and reputational damage228230 ITEM 2: Unregistered Sales of Equity and Securities and Use of Proceeds This item is not applicable for the current reporting period - This item is not applicable for the current reporting period231 ITEM 3: Defaults Upon Senior Securities This item is not applicable for the current reporting period - This item is not applicable for the current reporting period232 ITEM 4: Mine Safety Disclosures This item is not applicable for the current reporting period - This item is not applicable for the current reporting period233 ITEM 5: Other Information No other information is reported under this item - No other information is reported under this item234 ITEM 6: Exhibits The report includes various exhibits, such as the Amended and Restated Certificate of Incorporation, Bylaws, and certifications from officers - The report includes various exhibits, such as the Amended and Restated Certificate of Incorporation, Bylaws, and certifications from the Principal Executive and Financial Officers236237 SIGNATURES This section contains the required signatures for the Quarterly Report on Form 10-Q, certifying its accuracy and completeness - The report is signed on June 9, 2020, by Nick B. Tressler, Chief Financial Officer (Principal Financial Officer) of Senseonics Holdings, Inc243