Senseonics Holdings Inc
For the period ended Sep 30, 2024. Filed Nov 7, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 7, 2024
Extracted filing text, with the paragraph anchors used by the comparison.
See the whole filing, with its images and exhibitsContents
Notes to Unaudited Condensed Consolidated Financial Statements
| 1. | Organization and Nature of Operations |
Senseonics Holdings, Inc., a Delaware corporation, is a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (“CGM”) systems to improve the lives of people with diabetes by enhancing their ability to manage their disease with relative ease and accuracy.
Senseonics, Incorporated is a wholly owned subsidiary of Senseonics Holdings, Inc. and was originally incorporated on October 30, 1996, and commenced operations on January 15, 1997. Eon Care Services, LLC and Eon Management Services, LLC are wholly owned subsidiaries of Senseonics, Incorporated formed in April 2024 and July 2024, respectively. Senseonics Holdings, Inc. and its consolidated subsidiaries and affiliated entities, including its consolidated variable interest entities (“VIEs”) are hereinafter collectively referred to as the “Company”, unless otherwise indicated or the context otherwise requires.
| 2. | Liquidity and Capital Resources |
From its founding in 1996 until 2010, the Company has devoted substantially all of its resources to researching various sensor technologies and platforms. Beginning in 2010, the Company narrowed its focus to developing and refining a commercially viable glucose monitoring system. Since our inception, we have incurred significant net losses and expect to incur additional losses in the near future. We incurred total net (loss) income of ($60.4) million and $142.1 million for the years ended December 31, 2023 and 2022, respectively. For the nine months ending September 30, 2024, the Company had gross loss of ($3.4) million and an accumulated deficit of $932.4 million. To date, the Company has funded its operations principally through the issuance of preferred stock, common stock, warrants, convertible notes and debt. As of September 30, 2024, the Company had unrestricted cash, cash equivalents and marketable securities of $74.5 million.
The Company’s ability to grow revenues and achieve profitability depends on the successful commercialization and adoption of our implantable CGM (“Eversense”), including Eversense E3 CGM and Eversense 365 system, by diabetes patients and healthcare providers, along with future product development, regulatory approvals, and post-approval requirements. These activities and continued development of the Gemini product, Freedom product and other future products, will require significant uses of working capital through 2024 and beyond.
In accordance with the Financial Accounting Standards Board (FASB) Accounting Standards Codification, 205-40, Presentation of Financial Statements - Going Concern, management is required to assess the Company’s ability to continue as a going concern through twelve months after issuance of the financial statements. Based on the Company’s current operating plan, existing unrestricted cash, cash equivalents and marketable securities, anticipated debt repayments, and minimum cash and satisfaction of performance milestones to comply with debt covenants under its Loan and Security Agreement as discussed in Note 12, the Company has determined that substantial doubt exists regarding its ability to continue as a going concern for the one-year period following the date these condensed consolidated financial statements are issued. To sustain its future operations beyond such one-year period, the Company will require additional funding. As part of our liquidity strategy, we will continue to monitor our capital structure and market conditions, and we may finance our cash needs through public or private debt and equity financings and other sources which may include collaborations, strategic alliances, and licensing arrangements with third parties. There is no assurance that the Company will be successful in obtaining sufficient funding on acceptable terms, if at all, and could be forced to delay, reduce, or eliminate some or all of its research, clinical trials, product development or future commercialization efforts, which could materially adversely affect its business prospects or its ability to continue as a going concern. The accompanying condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Accordingly, the condensed consolidated financial statements have been prepared on a basis that assumes the Company will continue as a going concern and that contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business.
On September 8, 2023 (the “Effective Date”), the Company entered into a loan agreement (the “Loan and Security Agreement”) with the several institutions or entities party thereto (collectively, the “Lenders") and Hercules Capital, Inc., a Maryland corporation (“Hercules”) in its capacity as administrative agent and collateral agent for itself and the Lenders, pursuant to which the Lenders have agreed to make available to the Company up to $50.0 million in senior secured term loans (the “Term Loan Facility”), consisting of (i) an initial term loan of $25.0 million (the “Tranche 1 Loan”), which was funded on the Effective Date and (ii) two additional tranches of term loans in the amounts of up to $10.0 million (the “Tranche 2 Loan”) and $15.0 million (the “Tranche 3 Loan”), respectively, which will become available to the Company upon the Company’s satisfaction of certain terms and conditions set forth in the Loan and Security Agreement. In December 2023, we met the terms and conditions to draw on the Tranche 2 Loan and the loan was funded on January 2, 2024 in an amount of $10.0 million. The loans under the Loan and Security Agreement mature on September 1, 2027 (the “Maturity Date”).
On August 10, 2023, the Company entered into separate, privately negotiated exchange agreements (the “Exchange Agreements”) with a limited number of holders (the “Noteholders”) of the Company’s currently outstanding 5.25% Convertible Senior Notes due 2025 (the “2025 Notes”). Under the terms of the Exchange Agreements, the Noteholders agreed to exchange with the Company (the “Exchanges”) up to $30.8 million in aggregate principal amount of the 2025 Notes (the “Exchanged Notes”) for a combination of $7.5 million of cash and newly issued shares of common stock (the “Exchange Shares”). The number of Exchange Shares was determined based upon the volume-weighted average price per share of the common stock during a 15-day averaging period commencing on August 11, 2023 and ending August 31, 2023. Based on the volume-weighted average price per share of the common stock during the averaging period, a total of 35.1 million shares of common stock were issued in the Exchanges. The Exchanges were settled on the initial share issuance date of August 14, 2023 and the final settlement date of September 5, 2023.
In August 2023, the Company entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Goldman Sachs & Co. LLC (“GS”), under which the Company could offer and sell, from time to time, at its sole discretion, shares of its common stock having an aggregate offering price of up to $106.6 million through GS as its sales agent in an “at the market” offering, which represented the remaining capacity under our then-existing at the market program with Jefferies LLC (“Jefferies”), as described below. GS will receive a commission up to 3.0% of the gross proceeds of any common stock sold through GS under the Equity Distribution Agreement. The shares will be offered and sold pursuant to an effective shelf registration statement on Form S-3, which was originally filed with the Securities and Exchange Commission on August 10, 2023. On October 24, 2024, the Company amended the Equity Distribution Agreement with GS to reduce the maximum amount of shares issuable thereunder to $55.0 million. As of September 30, 2024, the Company received approximately $4.2 million in net proceeds from the sale of 10,766,983 shares under the Equity Distribution Agreement.
In November 2021, we entered into the 2021 Sales Agreement with Jefferies, under which we could offer and sell, from time to time, at our sole discretion, shares of our common stock having an aggregate offering price of up to $150.0 million through Jefferies as our sales agent in an “at the market” offering. Jefferies received commissions up to 3.0% of the gross proceeds of any common stock sold through Jefferies under the 2021 Sales Agreement. During 2023, the Company received $7.4 million in net proceeds from the sale of 9,944,663 shares of its common stock under the 2021 Sales Agreement. Effective August 7, 2023, the Company and Jefferies mutually agreed to terminate the 2021 Sales Agreement. At the time of termination, approximately $106.6 million remained available for issuance pursuant to the 2021 Sales Agreement.
On August 9, 2020, the Company entered into a financing agreement with the parent company of Ascensia Diabetes Care Holdings AG (“Ascensia”), PHC Holdings Corporation (“PHC”), pursuant to which the Company issued $35.0 million in aggregate principal amount of Senior Secured Convertible Notes due on October 31, 2024 (the “PHC Notes”), to PHC. The Company also issued 2,941,176 shares of common stock to PHC as a financing fee. The Company also had the option to sell and issue PHC up to $15.0 million of convertible preferred stock on or before December 31, 2022, contingent upon obtaining U.S. Food and Drug Administration (“FDA”) approval for the 180-day Eversense product for marketing in the United States before such date. The Company successfully obtained FDA approval in February 2022 and the option was not exercised. As described in Note 12, on March 13, 2023, the Company entered into
an Exchange Agreement (the “PHC Exchange Agreement”) with PHC, pursuant to which PHC agreed to exchange (the “PHC Exchange”) its $35.0 million aggregate principal amount of the PHC Notes, including all accrued and unpaid interest thereon, for a warrant (the “PHC Exchange Warrant”) to purchase up to 68,525,311 shares of the Company’s common stock, $0.001 par value per share (the “PHC Exchange Warrant Shares”). The PHC Exchange Warrant is a “pre-funded” warrant with a nominal exercise price of $0.001 per PHC Exchange Warrant Share. On March 31, 2023, (6:00 am Japan Standard Time on April 1, 2023) the PHC Exchange was consummated, and the Company issued the PHC Exchange Warrant in consideration for the cancellation of the PHC Notes.
On March 13, 2023, the Company entered into a securities purchase agreement (the “Securities Purchase Agreement”) with PHC, pursuant to which the Company issued and sold to PHC in a private placement (the “Private Placement”) a warrant (the “Purchase Warrant”) to purchase 15,425,750 shares of the Company’s common stock, $0.001 par value per share (the “Purchase Warrant Shares”). The purchase price of the Purchase Warrant was approximately $0.97 per Purchase Warrant Share, representing the undiscounted, trailing 10-day volume weighted average price of the Company’s common stock through March 10, 2023. The Purchase Warrant is a “pre-funded” warrant with a nominal exercise price of $0.001 per Purchase Warrant Share. The issuance of the Purchase Warrants enabled PHC to maintain, as of the closing of the transaction, a 15% beneficial ownership for purposes of the Investor Rights Agreement, dated August 9, 2020, between the Company and PHC. The Private Placement closed on March 13, 2023 (the “Private Placement Closing Date”) and the Company received aggregate gross proceeds of $15.0 million, before deducting private placement expenses payable by the Company.
| 3. | Summary of Significant Accounting Policies |
Basis of Presentation
The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and the instructions to Quarterly Report on Form 10-Q and Article 10 of Regulation S-X. Although the Company considers the disclosures in these unaudited consolidated financial statements to be adequate to make the information presented not misleading, certain information or footnote information normally included in consolidated financial statements prepared in accordance with U.S. GAAP have been condensed or omitted as permitted under the rules and regulations of the SEC. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) considered necessary for a fair statement of financial position at September 30, 2024, and December 31, 2023, results of operations, comprehensive income (loss), and changes in stockholders’ (deficit) equity for the three and nine months ended September 30, 2024 and 2023 and cash flows for the nine months ended September 30, 2024 and 2023 have been included. The unaudited condensed consolidated financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, as filed with the SEC on March 1, 2024. The interim results for September 30, 2024 are not necessarily indicative of the results to be expected for the year ending December 31, 2024, or for any future interim periods.
The unaudited condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. However, substantial doubt about the Company’s ability to continue as a going concern exists. As discussed in Note 2, based on the Company's current operating plan, existing unrestricted cash, cash equivalents and marketable securities, anticipated debt repayments, and minimum cash and satisfaction of performance milestones to comply with debt covenants under its Loan and Security Agreement as discussed in Note 12, the Company has determined that substantial doubt exists regarding its ability to continue as a going concern. The Company will require additional liquidity to continue its operations over the next 12 months and we are currently evaluating strategies to obtain the required additional funding for future operations.
In November 2024, Eon Management Services, LLC entered into management services agreements (the “Administrative Agreement”) for an initial fixed term of 10 years with several professional corporations created to support patient access to the Eversense system by contracting nurse practitioners and other healthcare professionals to perform Eversense insertion procedures and other clinical activities. Eon Care Clinicians PC, Eon Care Clinicians of NJ PC, and Eon Care Clinicians of CA PC (collectively referred to as “Eon Care PCs”) are the professional corporations that
were established pursuant to the requirements of its respective domestic jurisdiction governing the corporate practice of medicine.
In accordance with relevant accounting guidance, the Eon Care PCs have been determined to be VIEs of the Company, as the Company is its primary beneficiary with the ability, through the Administrative Agreement to direct the activities (excluding clinical activities) that most significantly affect the Eon Care PCs financial performance and have the obligation to absorb losses of, or the right to receive benefits from, the Eon Care PCs that could potentially be significant to it. Our variable interest entities’ assets, liabilities, and results of operations were not material to our consolidated financial results.
The Company also consolidates its wholly owned subsidiaries (Senseonics, Incorporated, Eon Care Services, LLC and Eon Management Services, LLC) as discussed in Note 1, Organization. All intercompany balances and transactions are eliminated upon consolidation.
The consolidated financial statements reflect the accounts of Senseonics Holdings, Inc. and its consolidated subsidiaries and affiliated entities, including its VIEs. The Company views its operations and manages its business inone segment, diabetes products and services. Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance.
Recent Accounting Pronouncements
In November 2023, the FASB issued ASU No. 2023-07,Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires that an entity report segment information in accordance with Topic 280, Segment Reporting. The amendment in the ASU is intended to improve reportable segment disclosure requirements primarily through enhanced disclosures about significant segment expenses. The amendments in this update are effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024, on a retrospective basis, with early adoption permitted. Adoption of this ASU will result in additional disclosure, but it will not impact the Company’s consolidated financial position, results of operations or cash flows.
In December 2023, the FASB issued Accounting Standards Update (“ASU”) No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures (“ASU 2023-09”), the objective of which is to enhance the transparency of income tax disclosures by requiring greater disaggregation of information presented and consistent categories in the rate reconciliation. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024, or our fiscal year 2025, using either a prospective or retrospective transition method, and early adoption is permitted. The Company is currently evaluating the impact of the new standard on its financial statements and disclosures.
Use of Estimates
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the reported amounts of revenue and expenses during the reporting period. In the accompanying unaudited consolidated financial statements, estimates are used for, but not limited to, stock-based compensation, recoverability of long-lived assets, deferred taxes and valuation allowances, fair value of investments, derivative assets and liabilities, obsolete inventory, warranty obligations, variable consideration related to revenue, allowance for credit losses, depreciable lives of property and equipment, and accruals for clinical study costs, which are accrued based on estimates of work performed under contract. The Company bases these estimates on historical and anticipated results, trends, and various other assumptions that it believes are reasonable, including assumptions as to future events. These estimates form the basis for making judgments about the carrying values of assets and liabilities and recorded revenues and expenses. Actual results could differ from those estimates; however, management does not believe that such differences would be material.
Significant Accounting Policies
The accounting policies used by the Company in its presentation of interim financial results are consistent with those presented in Note 3 to the consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023.
4. Revenue Recognition
The Company generates product revenue from sales of the Eversense system and related components and supplies to Ascensia, through a collaboration and commercialization agreement (the “Ascensia Commercialization Agreement”), third-party distributors outside the United States and to strategic fulfillment partners in the United States, who then resell the products to health care providers and patients, or directly to health care systems and health care providers (collectively, the “Customers”). Customers pay the Company for sales, regardless of whether or not the Customers resell the products to health care providers and patients. The Company also generates product revenue from sales of the Eversense system and related components and supplies through a consignment model with our network of healthcare professionals and revenue is recognized when the product is consumed by a patient. The Company’s policies for recognizing sales have not changed from those described in our Annual Report on Form 10-K for the year ended December 31, 2023.
Revenue by Geographic Region
The following table sets forth net revenue derived from the Company’stwo primary geographical markets, the United States and outside of the United States, based on the geographic location to which the Company delivers the product, for the nine months ended September 30, 2024 and 2023:
| | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| · Three Months Ended · · · Nine Months Ended · | |||||||||||
| · September 30, 2024 · · · September 30, 2024 · | |||||||||||
| · · · % · · · · · % · | |||||||||||
| (Dollars in thousands) · Amount · · of Total · · · Amount · · of Total · | |||||||||||
| Revenue, net: | | | | | | | | | | | |
| United States | $2,382 | | 55.9% | | $9,089 | | 64.1% | ||||
| Outside of the United States | | 1,881 | | 44.1 | | | | 5,086 | | 35.9 | |
| Total | $4,263 | | 100.0% | | $14,175 | | 100.0% | ||||
| | | | | | | | | | | | |
| | | | | | | | | | | | |
| | Three Months Ended | | Nine Months Ended | | |||||||
| | September 30, 2023 | | | September 30, 2023 | | ||||||
| | | | % | | | | | % | | ||
| (Dollars in thousands) | Amount | | of Total | | | Amount | | of Total | | ||
| Revenue, net: | | | | | | | | | | | |
| United States | $3,930 | | 64.5% | | $7,885 | | 54.9% | ||||
| Outside of the United States | | 2,167 | | 35.5 | | | | 6,475 | | 45.1 | |
| Total | $6,097 | | 100.0% | | $14,360 | | 100.0% | ||||
Contract Assets
Contract assets consist of unbilled receivables from customers and are recorded at net realizable value and relate to the revenue share variable consideration from the Ascensia Commercialization Agreement. Accounts receivable – related parties, net as of September 30, 2024 and December 31, 2023 included unbilled accounts receivable of$0.5 million and$1.5 million, respectively. The Company expects to invoice and collect all unbilled accounts receivable within 12 months.
Concentration of Revenue and Customers
For the three months ended September 30, 2024 and 2023, the Company derived 78% and 93%, respectively, of its total revenue fromone customer, Ascensia. For the nine months ended September 30, 2024 and 2023, the Company derived 84% and 92%, respectively, of its total revenue fromone customer, Ascensia. Revenues for these corresponding periods represent sales of sensors, transmitters and miscellaneous Eversense system components.
5. Net Loss per Share
Basic net loss per share attributable to common stockholders is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period. An aggregate of 83,951,061 shares of common stock issuable upon the exercise of the PHC Exchange Warrant Shares and the Purchase Warrant Shares held by PHC are included in the number of outstanding shares used for the computation of basic net loss per share for the three and nine months ended September 30, 2024 and 2023. Since the shares are issuable for little or no consideration, sometimes referred to as “penny warrants”, they are considered outstanding in the context of earnings per share, as discussed in ASC 260-10-45-13.
Dilutive net loss per share is computed using the weighted average number of common shares outstanding during the period and, when dilutive, potential common share equivalents. Potentially dilutive common shares consist of shares issuable from restricted stock units, stock options, warrants and the Company’s convertible notes. Potentially dilutive common shares issuable upon vesting of restricted stock units and exercise of stock options and warrants are determined using the average share price for each period under the treasury stock method. Potentially dilutive common shares issuable upon conversion of the Company’s convertible notes are determined using the if converted method. The if-converted method assumes conversion of convertible securities at the beginning of the reporting period. Interest expense, dividends, and the changes in fair value measurement recognized during the period are added back to the numerator. The denominator includes the common shares issuable upon conversion of convertible securities.
In periods of net loss, all potentially dilutive common shares are excluded from the computation of the diluted net loss per share for those periods, as the effect would be anti-dilutive.
The following table sets forth the computation of basic and diluted net loss per share for the periods shown:
| | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended September 30, · · · Nine Months Ended September 30, | |||||||||||
| · · 2024 · · 2023 · · · 2024 · · 2023 | |||||||||||
| | | | | | | | | | | | |
| Net loss | $(23,976) | | $(24,103) | | $(63,140) | | $(43,202) | ||||
| | | | | | | | | | | | |
| Impact of conversion of dilutive securities | | — | | | — | | | — | | | — |
| | | | | | | | | | | | |
| Dilutive Net loss | $(23,976) | | $(24,103) | | $(63,140) | | $(43,202) | ||||
| | | | | | | | | | | | |
| Net loss per share | | | | | | | | | | | |
| Basic | $(0.04) | | $(0.04) | | $(0.10) | | $(0.08) | ||||
| Diluted | $(0.04) | | $(0.04) | | $(0.10) | | $(0.08) | ||||
| | | | | | | | | | | | |
| Basic weighted average shares outstanding | | 620,897,955 | | | 592,452,262 | | | 617,370,311 | | | 552,703,546 |
| Dilutive potential common stock outstanding | | | | | | | | | | | |
| Dilutive potential common stock outstanding | | — | | | — | | | — | | | — |
| Diluted weighted average shares outstanding | | 620,897,955 | | | 592,452,262 | | | 617,370,311 | | | 552,703,546 |
Outstanding anti-dilutive securities not included in the diluted net loss per share calculations were as follows:
| | | | | | | | | |
|---|---|---|---|---|---|---|---|---|
| · · Three Months Ended September 30, · · Nine Months Ended September 30, | ||||||||
| · 2024 · 2023 · 2024 · · 2023 | ||||||||
| Stock-based awards | | 44,599,494 | | 31,953,024 | | 44,599,494 | | 31,953,024 |
| 2025 Notes | | 15,622,814 | | 15,622,814 | | 15,622,814 | | 15,622,814 |
| Energy Capital Preferred Shares | | 30,372,058 | | 30,372,058 | | 30,372,058 | | 30,372,058 |
| Warrants | | 1,440,500 | | 1,260,183 | | 1,440,500 | | 1,260,183 |
| Total anti-dilutive shares outstanding | | 92,034,866 | | 79,208,079 | | 92,034,866 | | 79,208,079 |
| 6. | Marketable Securities |
Marketable securities available for sale, were as follows (in thousands):
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · September 30, 2024 | ||||||||||||
| · · · · Gross · · Gross · · Estimated | ||||||||||||
| · · Amortized · · Unrealized · · Unrealized · · Market | ||||||||||||
| · Cost · Gains · Losses · Value | ||||||||||||
| Commercial Paper | | $7,439 | | $4 | | $— | | $7,443 | ||||
| Government and agency securities | | | 39,902 | | | 30 | | | — | | | 39,932 |
| Total | | $47,341 | | $34 | | $— | | $47,375 | ||||
| | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · December 31, 2023 | ||||||||||||
| · · · · Gross · · Gross · · Estimated | ||||||||||||
| · · Amortized · · Unrealized · · Unrealized · · Market | ||||||||||||
| · Cost · Gains · Losses · Value | ||||||||||||
| Commercial Paper | | $7,598 | | $— | | $— | | $7,598 | ||||
| Corporate debt securities | | | 7,980 | | | 1 | | | — | | | 7,981 |
| Government and agency securities | | | 18,180 | | | — | | | (12) | | | 18,168 |
| Total | | $33,758 | | $1 | | $(12) | | $33,747 | ||||
The following are the scheduled maturities as of September 30, 2024 (in thousands):
| · · · · · · | |||
|---|---|---|---|
| · · Net · · Fair | |||
| · · Carrying Amount · · Value | |||
| 2024 (remaining three months) | $47,341 | | $47,375 |
| Total | $47,341 | | $47,375 |
The Company periodically reviews its portfolio of debt securities to determine if any investment is impaired due to credit loss or other potential valuation concerns. For debt securities where the fair value of the investment is less than the amortized cost basis, the Company assesses at the individual security level, for various quantitative factors including, but not limited to, the nature of the investments, changes in credit ratings, interest rate fluctuations, industry analyst reports, and the severity of impairment. Unrealized losses on available-for-sale securities at September 30, 2024 were not significant and were primarily due to changes in interest rates and not due to increased credit risk associated with specific securities. The Company does not intend to sell these impaired investments and it is not more likely than not that the Company will be required to sell the investments before recovery of their amortized cost bases, which may be at maturity.
7. Inventory, net
Inventory, net of reserves, consisted of the following (in thousands):
| · · · · · · | ||||
|---|---|---|---|---|
| · September 30, · December 31, | ||||
| · · 2024 · 2023 | ||||
| Finished goods | $798 | $2,160 | ||
| Work-in-process | | 2,157 | | 5,332 |
| Raw materials | | 252 | | 1,284 |
| Total | | $3,207 | | $8,776 |
The Company charged $4.2 million in cost of sales for the three and nine months ended September 30, 2024 and less than $0.1 million in cost of sales for the three and nine months ended September 30, 2023 to reduce the value of inventory for items that are potentially obsolete due to expiry, in excess of product demand, or to adjust costs to their net realizable value. These costs were primarily write offs of our existing Eversense E3 systems following obtaining FDA 510(k) clearance to sell Eversense 365. In addition, we incurred $0.6 million in cost of sales due to impairment losses on prepayments to suppliers as the result of the transition from Eversense E3 to Eversense 365 system.
The Company capitalizes inventory costs associated with products when future commercialization is considered probable and the future economic benefit is expected to be realized, which is typically when regulatory approval is obtained. As such, the Company began capitalizing costs related to the 365-day product inventory in September 2024 upon successfully obtaining FDA 510(k) clearance. Prior to regulatory approval, the Company expensed all inventory-related costs, including that used for clinical development, to research and development expenses. We expect this to impact the cost of sales as the pre-clearance inventory is sold to customers. The Company incurred $1.9 million during the nine months ended September 30, 2024 and $0.3 million for the year ended December 31, 2023 in product costs prior to the clearance, which primarily consisted of work in process inventory.
8.Prepaid Expenses and Other Current Assets
Prepaid expenses and other current assets consisted of the following (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · September 30, · · December 31, | ||||||
| · · 2024 · 2023 | ||||||
| Contract manufacturing⁽¹⁾ | | $2,526 | | $4,244 | ||
| Tax credits receivable(2) | | | 1,793 | | | 1,793 |
| Clinical and Preclinical | | | 451 | | | 343 |
| IT and software | | 309 | | 242 | ||
| Insurance | | | 306 | | | 73 |
| Accounting and Audit | | | 157 | | | 61 |
| Rent and utilities | | | 99 | | | 122 |
| Sales and Marketing | | | 23 | | | 20 |
| Interest receivable | | | — | | | 272 |
| Research and development | | | — | | | 95 |
| Other | | | 1 | | | 1 |
| Total prepaid expenses and other current assets | | $5,665 | | $7,266 | ||
| (1) | Includes deposits to contract manufacturers for manufacturing process. |
| (2) | Refundable employee retention credits, enacted under the CARES Act. |
| 9. | Accrued Expenses and Other Current Liabilities |
Accrued expenses and other current liabilities consisted of the following (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · September 30, · · December 31, | ||||||
| · · 2024 · 2023 | ||||||
| Compensation and benefits | | $3,931 | | $4,799 | ||
| Research and development | | 3,536 | | 3,846 | ||
| Professional and administrative services | | | 2,143 | | | 673 |
| Contract manufacturing | | 1,797 | | 1,457 | ||
| Sales and marketing services | | 855 | | 301 | ||
| Interest on notes payable | | | 512 | | | 704 |
| Product warranty and replacement obligations | | | 415 | | | 514 |
| Operating lease | | | 413 | | | 368 |
| Accrued construction and renovation costs | | | 397 | | | — |
| Other | | | 27 | | | 27 |
| Total accrued expenses and other current liabilities | | $14,026 | | $12,689 | ||
| 10. | Leases |
The Company leases approximately 33,000 square feet of research and office space for its corporate headquarters under a non-cancelable operating lease. In May 2023, the Company amended our lease, extending the lease term through May 31, 2033, and obtained a tenant improvement allowance of $1.3 million. The Company accounted for the amendment as a lease modification and remeasured the ROU asset and lease liability as of the amendment date, which resulted in an increase of $2.5 million to the ROU asset, and an increase of $3.8 million to the lease liability. The Company hasone option to extend the term for an additional period offive years beginning on June 1, 2033. The rent expense is recognized on a straight-line basis through the end of the lease term, excluding option renewals. The difference between the straight-line rent amounts and amounts payable under the lease is recorded as deferred rent.
Operating lease expense for the nine months ended September 30, 2024 and 2023 was $0.7 million and $0.6 million, respectively.
The following table summarizes the lease assets and liabilities as of September 30, 2024 and December 31, 2023 (in thousands):
| | | | | | | | | |
|---|---|---|---|---|---|---|---|---|
| | | | | | | September 30, | | December 31, |
| Operating Lease Assets and Liabilities · · Balance Sheet Classification · · 2024 · 2023 | ||||||||
| Assets · · · · · · · | ||||||||
| Operating lease ROU assets | | | Deposits and other assets | | $4,925 | $5,180 | ||
| Liabilities | | | | | | | | |
| Current operating lease liabilities | | | Accrued expenses and other current liabilities | | $413 | $368 | ||
| Non-current operating lease liabilities | | | Other non-current liabilities | | | 5,899 | | 6,214 |
| Total operating lease liabilities | | | | | $6,312 | $6,582 | ||
The following table summarizes the maturity of undiscounted payments due under operating lease liabilities and the present value of those liabilities as of September 30, 2024 (in thousands):
| | | | |
|---|---|---|---|
| 2024 (remaining 3 months) | $231 | ||
| 2025 | | | 939 |
| 2026 | | | 967 |
| 2027 | | | 996 |
| 2028 | | | 1,026 |
| Thereafter | | | 4,908 |
| Total | | | 9,067 |
| Less: Present value adjustment | | | (2,755) |
| Present value of lease liabilities | | $6,312 | |
The following table summarizes the weighted-average lease term and weighted-average discount rate as of September 30, 2024:
| | | | |
|---|---|---|---|
| Remaining lease term (years) | | 2024 | |
| Operating leases | | 8.7 | |
| Discount rate | | | |
| Operating leases | | 8.5% | |
| | | | |
| 11. | Product Warranty Obligations |
The Company provides a warranty ofone year on its smart transmitters. Additionally, the Company may also replace Eversense system components that do not function in accordance with the product specifications. Estimated replacement costs are recorded at the time of shipment as a charge to cost of sales in the consolidated statement of operations and are developed by analyzing product performance data and historical replacement experience, including comparing actual replacements to revenue.
The warranty reserve was $0.4 million and $0.5 million for the periods ending September 30, 2024 and December 31, 2023, respectively. The following table provides a reconciliation of the change in estimated warranty
liabilities for the nine months ended September 30, 2024, and for the twelve months ended December 31, 2023 (in thousands):
| | | | | | | |
|---|---|---|---|---|---|---|
| · · September 30, · · December 31, | ||||||
| · 2024 · 2023 | ||||||
| Balance at beginning of the period | | $514 | | $781 | ||
| Provision for warranties during the period | | | 177 | | | 242 |
| Settlements made during the period | | | (276) | | | (509) |
| Balance at end of the period | | $415 | | $514 | ||
| 12. | Notes Payable, Preferred Stock and Stock Purchase Warrants |
Term Loans
Loan and Security Agreement
On September 8, 2023 (the “Effective Date”), the Company entered into a loan agreement (the “Loan and Security Agreement”) with Hercules Capital, Inc. and its managed fund (collectively, the “Lenders"), pursuant to which the Lenders have agreed to make available to Senseonics up to $50.0 million in senior secured term loans (the “Term Loan Facility”), consisting of (i) an initial term loan of $25.0 million (the “Tranche 1 Loan”), which was funded on the Effective Date and (ii) two additional tranches of term loans in the amounts of up to $10.0 million (the “Tranche 2 Loan”) and $15.0 million (the “Tranche 3 Loan”), respectively, which will become available to Senseonics upon Senseonics’ satisfaction of certain terms and conditions set forth in the Loan and Security Agreement. In December 2023, the Company met the terms and conditions to draw on Tranche 2 Loan and the loan was funded on January 2, 2024 in an amount of $10.0 million. The loans under the Loan and Security Agreement mature on September 1, 2027 (the “Maturity Date”).
The loans under the Loan and Security Agreement bear interest at an annual rate equal to the greater of (i) the prime rate as reported in The Wall Street Journal*plus** *1.40% and (ii)9.90%. Borrowings under the Loan and Security Agreement are repayable in monthly interest-only payments through (a) initially, September 1, 2026 and (b) if the Company satisfies the Interest Only Extension Conditions (as defined in the Loan and Security Agreement), the Maturity Date. After the interest-only payment period, borrowings under the Loan and Security Agreement are repayable in equal monthly payments of principal and accrued interest until the Maturity Date.
At the Company’s option, the Company may prepay all or any portion of the outstanding borrowings under the Loan and Security Agreement, subject to a prepayment fee equal to (a)3.0% of the principal amount being prepaid if the prepayment occurs within one year of the Effective Date,2.0% of the principal amount being prepaid if the prepayment occurs during the second year following the Effective Date, and 1.00% of the principal amount being prepaid if the prepayment occurs more than two years after the Effective Date and prior to the Maturity Date. In addition, the Company paid a $375,000 facility fee upon closing and will pay additional facility charges in connection with any borrowing of the Tranche 2 Loan or Tranche 3 Loan, in each case in the amount of 0.50% of the amount of such tranche of loans. The Loan and Security Agreement also provides for an end of term fee in an amount equal to 6.95% of the aggregate principal amount of loan advances actually made under the Loan and Security Agreement, which fee is due and payable on the earliest to occur of (i) the Maturity Date, (ii) the date the Company prepays the outstanding loans in full, and (iii) the date that the secured obligations become due and payable. The end of term fee is accreted to interest expense over the term of the loans.
The Company’s obligations under the Loan and Security Agreement are secured, by a first-priority security interest in substantially all of its assets. The Loan and Security Agreement contains a minimum cash covenant that requires the Company to hold unrestricted cash equal to 30% of the total amounts funded under the Loan and Security Agreement. The Loan and Security Agreement also contains a performance covenant, commencing on July 1, 2024, that requires the Company to generate net product revenue on a trailing six-month basis in excess of specified percentage for
applicable measuring periods. The performance covenant shall be waived at any time in which either (a) the Company’s market capitalization exceeds $550.0 million and the Company maintains unrestricted cash equal to at least 50% of the total amounts funded, or (b) the Company maintains unrestricted cash equal to at least 80% of the total amounts funded.
In addition, the Loan and Security Agreement contains customary representations and warranties and customary affirmative and negative covenants, including, among other things, restrictions on indebtedness, liens, investments, mergers, corporate changes, dispositions, prepayment of other indebtedness, and dividends and other distributions, subject to certain exceptions. The Loan and Security Agreement also contains events of default including, among other things, payment defaults, breach of covenants, material adverse effect, breach of representations and warranties, cross-default to material indebtedness, bankruptcy-related defaults, judgment defaults, revocation of certain government approvals, and the occurrence of certain adverse events. Following an event of default and any applicable cure period, a default interest rate equal to the then-applicable interest rate plus 4.0% may be applied to the outstanding amount, and the Lenders will have the right to accelerate all amounts outstanding under the Loan and Security Agreement, in addition to other remedies available to them as secured creditors of the Company.
In addition, in connection with the issuance of the Tranche 1 Loan, the Company issued warrants to the Lenders (collectively, the “Warrants”) to acquire an aggregate of 832,362 shares of the Company’s common stock at an exercise price of $0.6007 per share (the “Warrant Shares”). The Warrants may be exercised through the earlier of (i) the seventh anniversary of the Effective Date and (ii) the consummation of certain acquisition transactions involving the Company, as set forth in the Warrants. The number of Warrant Shares for which the Warrants are exercisable, and the associated exercise price are subject to certain customary proportional adjustments for fundamental events, including stock splits and reverse stock splits, as set forth in the Warrants. The proceeds from the Loan and Security Agreement were allocated between the Tranche 1 Loan and the Warrants based on their respective fair value of $25.0 million and $0.4 million, and the amount allocated to the Warrants was recorded in equity resulting in a debt discount to the Tranche 1 Loan that is being amortized as additional interest expense over the term of the Loan and Security Agreement using the effective interest method. On January 2, 2024, in connection with the issuance of the Tranche 2 Loan the Company issued additional warrants to the Lenders (collectively, the Tranche 2 Warrants”) to acquire an aggregate of 347,887 shares at an exercise price of $0.5749 per share (the “Tranche 2 Warrant Shares”).
In connection with Loan and Security Agreement, the Company incurred $1.1 million in debt issuance costs and debt discounts which are netted against the principal balance of the initial term loan and amortized as interest expense over the term of the initial term loan using an effective interest rate of 12.92%.
Pursuant to the Loan and Security Agreement, the Company also agreed to issue additional seven year term warrants upon the funding of the Tranche 3 Loan, which warrants would be exercisable for an aggregate number of shares equal to 2.0% of the funded loan amount divided by the exercise price equal to thethree-day volume-weighted average price at the time of each advance.
Convertible Preferred Stock and Warrants
Securities Purchase Agreement
On March 13, 2023, pursuant to the Securities Purchase Agreement with PHC, the Company issued and sold to PHC in a private placement a warrant (the “Purchase Warrant”) to purchase 15,425,750 shares of common stock (the “Purchase Warrant Shares”). The Purchase Warrant is a “pre-funded” warrant with a nominal exercise price of $0.001 per Purchase Warrant Share. On the Private Placement Closing Date, the Company received aggregate gross proceeds of $15.0 million, before deducting private placement expenses payable by the Company. All or any part of the Purchase Warrant is exercisable by the holder at any time and from time to time.
The Company determined that the Purchase Warrant shall be classified as equity in accordance with ASC Topic 480, Distinguishing Liabilities from Equity and ASC Topic 815. At issuance, the Company recorded the estimated fair value of the Purchase Warrant in the amount of $14.3 million as additional paid-in-capital in the Company’s consolidated balance sheets.
Because PHC was an existing stockholder of the Company at the time of the transaction, the $0.7 million excess of the purchase price over the fair value of the Purchase Warrant was recognized as an equity transaction and recorded as a capital contribution made by PHC to the Company as additional paid-in-capital in the Company’s consolidated balance sheets.
Additionally, on March 13, 2023, the Company entered into the Exchange Agreement with PHC, pursuant to which PHC agreed to exchange (the “PHC Exchange”) its $35.0 million aggregate principal amount of the PHC Notes, including all accrued and unpaid interest thereon, for a warrant (the “PHC Exchange Warrant”) to purchase up to 68,525,311 shares of common stock (the “PHC Exchange Warrant Shares”). The PHC Exchange Warrant is a “pre-funded” warrant with a nominal exercise price of $0.001 per PHC Exchange Warrant Share. All or any part of the PHC Exchange Warrant is exercisable by the holder at any time and from time to time. The number of PHC Exchange Warrant Shares represents the number of shares of common stock previously issuable upon conversion of the PHC Notes, in accordance with the original terms of the notes, including a number of shares in respect of accrued and unpaid interest through the closing date, plus additional shares with a value of $675,000 reflecting a portion of the future interest payments forgone by PHC. On March 31, 2023 (6:00 am Japan Standard Time on April 1, 2023), the PHC Exchange was consummated, and the Company issued the PHC Exchange Warrant in consideration for the cancellation of the PHC Notes.
The Company determined that the PHC Exchange Warrant shall be classified as equity in accordance with ASC 480 and ASC 815. On March 31, 2023, the Company recorded the estimated fair value of the PHC Exchange Warrant in the amount of$48.6 million as additional paid-in-capital in the Company’s consolidated balance sheets.
As of September 30, 2024, the Purchase Warrant and the PHC Exchange Warrant remained unexercised and outstanding. As they are prefunded warrants, the Company included the entirety of the warrant shares as weighted average outstanding shares in the calculation of its basic earnings per share.
Convertible Notes
PHC Notes
On August 9, 2020, the Company entered into a Note Purchase Agreement (the “Note Purchase Agreement”) with PHC, as the purchaser (together with the other purchasers from time-to-time party thereto, the “Note Purchasers”) and Alter Domus (US) LLC, as collateral agent. Pursuant to the Note Purchase Agreement, the Company borrowed$35.0 million in aggregate principal through the issuance and sale of the PHC Notes on August 14, 2020 (the “Closing Date”). The Company also issued 2,941,176 shares of its common stock,$0.001 par value per share to PHC as a financing fee (the “Financing Fee Shares”) on the Closing Date. The Financing Fee Shares are accounted for as debt discount in the amount of$1.5 million.
The PHC Notes were senior secured obligations of the Company and were guaranteed on a senior secured basis by the Company’s wholly owned subsidiary, Senseonics, Incorporated. Interest at the initial annual rate of 9.5% is payable semi-annually in cash or, at the Company’s option, payment in kind. The interest rate decreased to 8.0% in April 2022 as a result of the Company having obtained FDA approval for the 180-day Eversense E3 system for marketing in the United States. The maturity date for the PHC Notes was October 31, 2024 (the “Maturity Date”). The obligations under the PHC Notes were secured by substantially all of the Company’s and its subsidiary’s assets.
Each$1,000 of principal of the PHC Notes (including any interest added thereto as payment in kind) was convertible into 1,901.7956 of shares of the Company’s stock, equivalent to a conversion price of approximately$0.53 per share, subject to specified anti-dilution adjustments, including adjustments for the Company’s issuance of equity securities on or prior to April 30, 2022 below the conversion price. In addition, following a notice of redemption or certain corporate events that occurred prior to the maturity date, the Company would have been required to pay cash in lieu of delivering make whole shares unless the Company obtained stockholder approval to issue such shares.
Subject to specified conditions, on or after October 31, 2022, the PHC Notes would have become redeemable by the Company if the closing sale price of the common stock were to exceed 275% of the conversion price for a specified period of time and subject to certain conditions upon 10 days prior written notice at a cash redemption price equal to the then outstanding principal amount (including any payment in kind interest which has been added to such amount), plus any accrued but unpaid interest. On or after October 31, 2023, the PHC Notes would have become redeemable by the Company upon 10 days prior written notice at a cash redemption price equal to the then outstanding principal amount (including any payment in kind interest which had been added to such amount), plus any accrued but unpaid interest, plus a call premium of 130% if redeemed at least six months prior to the Maturity Date or a call premium of 125% if redeemed within six months of the Maturity Date.
The Note Purchase Agreement contained customary terms and covenants, including financial covenants, such as operating within an approved budget and achieving minimum revenue and liquidity targets, and negative covenants, such as limitations on indebtedness, liens, mergers, asset transfers, certain investing activities and other matters customarily restricted in such agreements. Most of these restrictions were subject to certain minimum thresholds and exceptions. The Note Purchase Agreement also contained customary events of default, after which the PHC Notes would have become due and payable immediately, including defaults related to payment compliance, material inaccuracy of representations and warranties, covenant compliance, material adverse changes, bankruptcy and insolvency proceedings, cross defaults to certain other agreements, judgments against the Company, change of control or delisting events, termination of any guaranty, governmental approvals, and lien priority.
The Company also had the option to sell and issue PHC up to$15.0 million of convertible preferred stock on or before December 31, 2022 (the “PHC Option”), which was initially contingent upon obtaining FDA approval for the 180-day Eversense product for marketing in the United States before such date, and which approval the Company successfully obtained in February 2022. The PHC option was not exercised and expired on December 31, 2022 and the Company recognized a loss on extinguishment of $0.1 million.
The Note Purchase Agreement also contained several provisions requiring bifurcation as a separate derivative liability including an embedded conversion feature, mandatory prepayment upon event of default that constitutes a breach of the minimum revenue financial covenant, optional redemption upon an event of default, change in interest rate after PMA approval and default interest upon an event of default. On the date of issuance, the Company recorded the fair value of the embedded features in the amount of$25.8 million as a derivative liability in the Company’s consolidated balance sheets in accordance with ASC 815. The derivative was adjusted to fair value at each reporting period, with the change in the fair value recorded in change in fair value of derivatives that is a component of other income (expense) in the Company’s consolidated statement of operations and comprehensive loss.
In connection with the issuance of the PHC Notes, the Company incurred$2.9 million in debt issuance costs and debt discounts. The associated debt issuance costs were recorded as a contra liability in the amount of$1.4 million and were deferred and amortized as additional interest expense over the term of the notes at an effective interest rate of 29.19%. There wereno conversions of the PHC Notes prior to the exchange of the PHC Notes for the PHC Exchange Warrant described above.
As described above, the PHC Exchange Agreement with PHC was consummated on March 31, 2023, whereby PHC exchanged the PHC Notes in$35.0 million principal amount and all accrued and unpaid interest for the PHC Exchange Warrant. On March 31, 2023, the Company was released from its obligation under the PHC Notes.
Upon execution of the PHC Exchange Agreement, the exercise of the original conversion feature of the PHC Notes became remote. Accordingly, the Company remeasured the embedded derivative to its fair value of$0. The Company recognized a change in fair value of the embedded derivative of$44.2 million in the caption “Exchange related gain (loss), net” that is a component of other income (expense) in the Company’s consolidated statement of operations and comprehensive loss.
The Company accounted for the PHC Exchange as an extinguishment of the PHC Notes, and thus, it derecognized the PHC Notes in its consolidated balance sheets and recognized a loss of$25.4 million as the difference between the carrying value plus accrued interest of the PHC Notes of$23.2 million and the$48.6 million fair value of
the PHC Exchange Warrant as an extinguishment loss in the caption “Exchange related gain, net” that is a component of other income (expense) in the Company’s consolidated statement of operations and comprehensive loss. As a result of the PHC Exchange, the Company recognized a total net gain on exchange of the PHC notes of$18.8 million representing the gain on change in the fair value of the PHC Notes conversion feature recognized as an embedded derivative and the loss on extinguishment of the PHC Notes in exchange for the PHC Exchange Warrant.
2025 Notes
In July 2019, the Company issued$82.0 million in aggregate principal amount of senior convertible notes that will mature on January 15, 2025 (the “2025 Notes”), unless earlier repurchased or converted. The 2025 Notes are convertible, at the option of the holders, into shares of the Company’s common stock, at an initial conversion rate of 757.5758 shares per$1,000 principal amount of the 2025 Notes (equivalent to an initial conversion price of approximately$1.32 per share).
The 2025 Notes also contained an embedded conversion option requiring bifurcation as a separate derivative liability, along with the fundamental change make-whole provision and the cash settled fundamental make-whole shares provision. The derivative is adjusted to fair value at each reporting period, with the change in the fair value recorded to other income (expense) in the Company’s consolidated statement of operations and comprehensive loss.
On April 21, 2020,$24.0 million aggregate principal of the Company’s outstanding 2025 Notes held by Highbridge Capital Management, LLC (“Highbridge”) were settled pursuant to an exchange agreement. Between September 3, 2020 and January 27, 2021,$6.8 million in aggregate principal of the 2025 Notes were converted into 5,152,259 shares of common stock. Accordingly,$3.2 million of allocated deferred issuance costs and debt discounts were recognized as a loss on extinguishment of debt.
On August 10, 2023, the Company entered into separate, privately negotiated exchange agreements (the “Exchange Agreements”) with a limited number of holders (the “Noteholders”) of the Company’s currently outstanding 2025 Notes. Under the terms of the Exchange Agreements, the Noteholders agreed to exchange with the Company (the “Exchanges”) up to $30.8 million in aggregate principal amount of the 2025 Notes (the “Exchanged Notes”) for a combination of $7.5 million of cash and newly issued shares of common stock (the “Exchange Shares”). The number of Exchange Shares was determined based upon the volume-weighted average price per share of the common stock during a 15-day averaging period commencing on August 11, 2023 and ending August 31, 2023. Based on the volume-weighted average price per share of the common stock during the averaging period, a total of 35.1 million shares of common stock were issued in the Exchanges. The Exchanges were settled on the initial share issuance date of August 14, 2023 and the final settlement date of September 5, 2023.
The Company accounted for the Exchanges as an extinguishment of the Exchanged Notes and the associated embedded derivative and recognized a loss of $4.6 million in the caption “Exchange related gain (loss), net” that is a component of other income (expense) in the Company’s consolidated statement of operations and comprehensive loss. The extinguishment loss represents the difference between (i) the carrying value of the Exchanged Notes (inclusive of the fair value of the embedded derivative) and (ii) the sum of $7.5 million cash payment, the fair value of the Exchanged Shares, and transaction costs incurred in the Exchange.
Following the Exchanges, approximately $20.4 million aggregate principal amount of the 2025 Notes remain outstanding. The remaining unamortized debt discount and debt issuance costs are amortized as interest expense over the term of the loan at an effective interest rate of 15.54%. The fair value of the derivative at September 30, 2024 and December 31, 2023 was $0.0 million and $0.1 million, respectively.
2023 Notes
In the first quarter of 2018, the Company issued$53.0 million in aggregate principal amount of senior convertible notes due February 1, 2023 (the “2023 Notes”). In July 2019, the Company used the net proceeds from the issuance of the 2025 Notes to repurchase$37.0 million aggregate principal amount of the outstanding 2023 Notes. Each$1,000 of principal of the 2023 Notes is initially convertible into 294.1176 shares of the Company’s common stock,
which is equivalent to an initial conversion price of approximately$3.40 per share, subject to adjustment upon the occurrence of specified events. Holders may convert at any time prior to February 1, 2023. Holders who convert on or after the date that is six months after the last date of original issuance of the 2023 Notes but prior to February 1, 2021, may also be entitled to receive, under certain circumstances, an interest make-whole payment payable in shares of common stock. If specific corporate events occur prior to the maturity date, the Company will increase the conversion rate pursuant to the make-whole fundamental change provision for a holder who elects to convert their 2023 Notes in connection with such an event in certain circumstances. Additionally, if a fundamental change occurs prior to the maturity date, holders of the 2023 Notes may require the Company to repurchase all or a portion of their 2023 Notes for cash at a repurchase price equal to 100% of the principal amount plus any accrued and unpaid interest.
The Company bifurcated the embedded conversion option, along with the interest make-whole provision and make-whole fundamental change provision, and in January 2018 recorded the embedded features as a debt discount and derivative liability in the Company’s consolidated balance sheets at its initial fair value of $17.3 million. Additionally, the Company incurred transaction costs of $2.2 million. The debt discount and transaction costs are being amortized to interest expense over the term of the 2023 Notes at an effective interest rate of 9.30%. The derivative is adjusted to fair value at each reporting period, with the change in the fair value recorded to other income (expense) in the Company’s consolidated statement of operations and comprehensive loss. On January 31, 2023, the Company repaid the outstanding principal and accrued interest in full. The derivative was unexercised upon maturity and the fair value in the amount of $0.02 million was recognized as an extinguishment gain in the caption “Other income (expense)” in Company’s consolidated statement of operations and comprehensive loss.
The following carrying amounts were outstanding under the Company’s notes payable as of September 30, 2024 and December 31, 2023 (in thousands):
| | | | | | | | |
|---|---|---|---|---|---|---|---|
| | September 30, 2024 | ||||||
| | Principal ($) | | Debt (Discount) Premium ($)⁽¹⁾ | | Issuance Costs ($) | | Carrying Amount ($) |
| 2025 Notes | 20,399 | | (1,006) | | (17) | | 19,376 |
| Loan and Security Agreement | 35,000 | | (280) | | (272) | | 34,448 |
| | | | | | | | |
| | December 31, 2023 | ||||||
| | Principal ($) | | Debt (Discount) Premium ($)⁽¹⁾ | | Issuance Costs ($) | | Carrying Amount ($) |
| 2025 Notes | 20,399 | | (3,090) | | (52) | | 17,257 |
| Loan and Security Agreement | 25,000 | | (733) | | (329) | | 23,938 |
| (1) | Includes accretion of end of term fees payable at maturity |
Interest expense related to the notes payable for the nine months ended September 30, 2024 and 2023 was as follows (dollars in thousands):
| | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|
| | Nine Months Ended September 30, 2024 | ||||||||
| | Interest Rate | | Interest ($) | | Debt Discount and Fees ($)⁽¹⁾ | | Issuance Costs ($) | | Total Interest Expense ($) |
| 2025 Notes | 5.25% | | 803 | | 2,083 | | 35 | | 2,921 |
| Loan and Security Agreement | 9.90% | | 2,635 | | 651 | | 59 | | 3,345 |
| Total | | | 3,438 | | 2,734 | | 94 | | 6,266 |
| | | | | | | | | | |
| | | | | | | | | | |
| | Nine Months Ended September 30, 2023 | ||||||||
| | Interest Rate | | Interest ($) | | Debt Discount and Fees ($)⁽¹⁾ | | Issuance Costs ($) | | Total Interest Expense ($) |
| 2023 Notes | 5.25% | | 69 | | 120 | | - | | 189 |
| 2025 Notes | 5.25% | | 1,881 | | 4,808 | | 81 | | 6,770 |
| PHC Notes | 8.00% | | 700 | | 1,442 | | 88 | | 2,230 |
| Loan and Security Agreement | 9.90% | | 158 | | 38 | | 3 | | 199 |
| Total | | | 2,808 | | 6,408 | | 172 | | 9,388 |
| | | | | | | | | | |
| | | | | | | | | | |
| (1) | Includes accretion of end of term fees payable at maturity |
The following are the scheduled maturities of the Company’s notes payable (including end of term fees) as of September 30, 2024 (in thousands):
| | | | |
|---|---|---|---|
| 2025 | | | 20,399 |
| 2026 | | | 12,996 |
| 2027 | | | 24,437 |
| Total | $57,832 | ||
| 13. | Stockholders’ (Deficit) Equity |
In November 2021, the Company entered into the 2021 Sales Agreement with Jefferies, under which the Company could offer and sell, from time to time, at its sole discretion, shares of its common stock having an aggregate offering price of up to $150.0 million through Jefferies as the sales agent in an “at the market” offering. Jefferies received commissions up to 3.0% of the gross proceeds of any common stock sold through Jefferies under the 2021 Sales Agreement. In 2023, the Company received $7.4 million in net proceeds from the sale of 9,944,663 shares of its common stock under the 2021 Sales Agreement. Effective August 7, 2023, the Company and Jefferies mutually agreed to terminate the 2021 Sales Agreement. At the time of termination, approximately $106.6 million remained available for issuance pursuant to the 2021 Sales Agreement.
In August 2023, the Company entered into an Equity Distribution Agreement (the “Equity Distribution Agreement”) with Goldman Sachs & Co. LLC (“GS”), under which the Company could offer and sell, from time to time, at its sole discretion, shares of its common stock having an aggregate offering price of up to $106.6 million through GS as its sales agent in an “at the market” offering. GS will receive a commission up to 3.0% of the gross proceeds of any common stock sold through GS under the Equity Distribution Agreement. The shares of the Company’s common stock will be offered and sold pursuant to an effective shelf registration statement on Form S-3, which was originally filed by the Company with the Securities and Exchange Commission on August 10, 2023. On October 24, 2024, the Company amended the Equity Distribution Agreement with GS to reduce the maximum amount of shares issuable thereunder to $55.0 million. As of September 30, 2024, the Company received approximately $4.2 million in net proceeds from the sale of 10,766,983 shares of its common stock under the Equity Distribution Agreement.
14. Stock-Based Compensation
2015 Plan
In December 2015, the Company adopted the 2015 Equity Incentive Plan (the “2015 Plan”), under which incentive stock options, non-qualified stock options and restricted stock units may be granted to the Company’s employees and certain other persons, such as officers and directors, in accordance with the 2015 Plan provisions. In February 2016, the Company’s Board of Directors adopted, and the Company’s stockholders approved, an Amended and Restated 2015 Equity Incentive Plan (the “Amended and Restated 2015 Plan”), which became effective on February 20, 2016. The Company’s Board of Directors may terminate the Amended and Restated 2015 Plan at any time. Options granted under the Amended and Restated 2015 Plan expireten years after the date of grant.
Pursuant to the Amended and Restated 2015 Plan, the number of shares of the Company’s common stock reserved for issuance automatically increases on January 1 of each year, ending on January 1, 2026, by 3.5% of the total number of shares of its common stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares as may be determined by its Board of Directors. As of September 30, 2024,27,817,546 shares remained available for grant under the Amended and Restated 2015 Plan.
Inducement Plan
On May 30, 2019, the Company adopted the Senseonics Holdings, Inc. Inducement Plan (the “Inducement Plan”), pursuant to which the Company reserved 1,800,000 shares of the Company’s common stock for issuance. The only persons eligible to receive grants of awards under the Inducement Plan are individuals who satisfy the standards for inducement grants in accordance with NYSE American Company Guide Section 711(a), including individuals who were
not previously an employee or director of the Company, or following a bona fide period of non-employment, as an inducement material to such persons entering into employment with the Company. An “Award” is any right to receive the Company’s common stock pursuant to the Inducement Plan, consisting of non-statutory options, restricted stock unit awards and other equity incentive awards. As of September 30, 2024,345,969 shares remained available for grant under the Inducement Plan.
Commercial Equity Plan
On January 30, 2023, the Company adopted the Senseonics Holdings, Inc. 2023 Commercial Equity Plan (the “Commercial Equity Plan”), pursuant to which the Company reserved 10,000,000 shares of common stock for issuance. Eligible recipients under the plan are non-employees of Senseonics, including employees of our global commercial partner, Ascensia, who assist with the commercialization of our products. An “Award” is any right to receive the Company’s common stock pursuant to the Commercial Equity Plan, consisting of non-statutory options and restricted stock unit awards. As of September 30, 2024,7,700,000 shares remained available for grant under the Commercial Equity Plan.
2016 Employee Stock Purchase Plan
In February 2016, the Company adopted the 2016 Employee Stock Purchase Plan, (the “2016 ESPP”). The 2016 ESPP became effective on March 17, 2016. The maximum number of shares of common stock that may be issued under the 2016 ESPP was initially 800,000 shares and automatically increases on January 1 of each year, ending on and including January 1, 2026, by 1.0% of the total number of shares of common stock outstanding on December 31 of the preceding calendar year; provided, however, the Board of Directors may act prior to the first day of any calendar year to provide that there will be no January 1 increase in the share reserve for such calendar year or that the increase in the share reserve for such calendar year will be a lesser number of shares of common stock. As of September 30, 2024, there were 22,521,176 shares of common stock available for issuance under the 2016 ESPP. For the nine months ended September 30, 2024, there were purchases of 407,048 shares of common stock pursuant to the 2016 ESPP.
The 2016 ESPP permits participants to purchase shares of the Company’s common stock through payroll deductions of up to 15% of their earnings. Unless otherwise determined by the administrator, the purchase price of the shares will be 85% of the lower of the fair market value of common stock on the first day of an offering or on the date of purchase. Participants may end their participation at any time and deductions not yet used in a purchase are refundable upon employment termination. The Company initiated its first 2016 ESPP offering period on August 1, 2019 and new offering periods occur everysix months thereafter, each consisting oftwo purchase periods ofsix months in duration ending on or about January 31 st and July 31 st of each year. A participant may only be in one offering at a time. The 2016 ESPP contains an offering reset provision whereby if the fair market value of a share on offering date of an ongoing offering is less than or equal to the fair market value of a share on a new offering date, the ongoing offering will terminate immediately after the purchase date and rolls over to the new offering.
The 2016 ESPP is considered compensatory for financial reporting purposes.
1997 Plan
On May 8, 1997, the Company adopted the 1997 Stock Option Plan (the “1997 Plan”), under which incentive stock options, non-qualified stock options, and restricted stock awards may be granted to the Company’s employees and certain other persons in accordance with the 1997 Plan provisions. All awards issued under the 1997 Plan are fully vested. Approximately 823,389 shares of the Company’s common stock underlying options remain outstanding under the 1997 Plan. Upon the effectiveness of the 2015 Plan, the Company no longer grants any awards under the 1997 Plan.
| 15. | Fair Value Measurements |
The following table represents the fair value hierarchy of the Company’s financial assets and liabilities measured at fair value on a recurring basis at September 30, 2024 and December 31, 2023 (in thousands):
| | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · September 30, 2024 | |||||||||||||
| · Total · Level 1 · Level 2 · Level 3 | |||||||||||||
| Assets | | | | | | | | | | | | | |
| Money market funds⁽¹⁾ | | $19,401 | | $19,401 | | | — | | | — | | ||
| Commercial paper | | | 7,443 | | | — | | | 7,443 | | | — | |
| Government and agency securities | | | 39,932 | | | 39,932 | | | — | | | — | |
| | | | | | | | | | | | | | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| · · December 31, 2023 | |||||||||||||
| · Total · Level 1 · Level 2 · Level 3 | |||||||||||||
| Assets | | | | | | | | | | | | | |
| Money market funds⁽¹⁾ | | $72,953 | | $72,953 | | | — | | | — | | ||
| Commercial paper | | | 7,598 | | | — | | | 7,598 | | | — | |
| Corporate debt securities | | | 7,982 | | | — | | | 7,982 | | | — | |
| Government and agency securities | | | 18,167 | | | 18,167 | | | — | | | — | |
| Liabilities | | | | | | | | | | | | | |
| Embedded features of the 2025 Notes | | $102 | | | — | | | — | | | 102 | | |
(1)Classified as cash and cash equivalents due to their short-term maturity
The following table provides a reconciliation of the beginning and ending net balances of items measured at fair value on a recurring that used significant unobservable inputs (Level 3) (in thousands):
| | | | |
|---|---|---|---|
| · · | |||
| · · Level 3 | |||
| | Instruments | ||
| December 31, 2023 | | $102 | |
| Gain on change in fair value of embedded features of the 2025 Notes | | | (102) |
| September 30, 2024 | | $— | |
The recurring Level 3 fair value measurements of the embedded features of the notes payable and preferred stock, include the following significant unobservable inputs at September 30, 2024:
| | | | | | | |
|---|---|---|---|---|---|---|
| · · · · | ||||||
| | | | | | | |
| · · 2025 Notes · · · | ||||||
| Unobservable Inputs | | Assumptions | | | | |
| Stock price volatility | 45.0% | | | | ||
| Probabilities of conversion provisions | 10 - 90% | | | | ||
| Credit spread | | 14.3% | | | | |
| | | | | | | |
| | | | | | | |
| 16. | Income Taxes |
The Company hasnot recorded any tax provision or benefit for the nine months ended September 30, 2024 or 2023. The Company has provided a valuation allowance for the full amount of its net deferred tax assets since realization of any future benefit from deductible temporary differences, NOL carryforwards and research and development credits is not more-likely-than-not to be realized at September 30, 2024 and December 31, 2023.
17. Related Party Transactions
PHC has a noncontrolling ownership interest in the Company. In addition, PHC has representation on the Company’s board of directors. The Company entered into a financing agreement with PHC on August 9, 2020 and entered into an exchange agreement with PHC during 2023 (see Note 12 for further discussion). Ascensia, through the ownership interests of its parent company, PHC, is a related party.
Revenue from Ascensia during the nine months ended September 30, 2024 and 2023 was $11.9 million and $13.2 million, respectively. We also purchase certain medical supplies from Ascensia for our clinical trials. We paid Ascensia$0.1 million and$0.6 million duringthe nine months ended September 30, 2024 and 2023, respectively under this arrangement.
The amount due from Ascensia as of September 30, 2024 and December 31, 2023 was$2.5 million and$3.7 million, respectively. The amount due to Ascensia as of September 30, 2024 and December 31, 2023 was$1.4 million and$0.5 million, respectively.
18. Subsequent Events
The Company has evaluated all subsequent events through the filing date of this Form 10-Q with the SEC, to ensure that this filing includes appropriate disclosure of events both recognized in the financial statements as of September 30, 2024, and events which occurred subsequently but were not recognized in the financial statements. Except as described below there were no other subsequent events which required recognition, adjustment to or disclosure in the financial statements.
On October 24, 2024, the Company amended the Equity Distribution Agreement with GS. As amended, the Equity Distribution Agreement permits the Company to issue and sell an aggregate of up to $55.0 million of common stock through GS, acting as its agent in an at the market offering.
On October 24, 2024, the Company entered into a securities purchase agreement with certain institutional investors to issue and sell (i) in a registered direct offering an aggregate of 45,714,286 shares of the Company’s common stock, $0.001 par value per share (the “Shares”) and (ii) in a concurrent private placement, warrants to purchase an aggregate of 45,714,286 shares of common stock (the “Warrants”). The combined purchase price of each Share and accompanying Warrant was $0.35 per share for total gross proceeds of $16.0 million. The Shares and the Warrants were immediately separable and were issued separately. The Warrants have an exercise price of $0.35 per share, are non-exercisable for the firstsix months after issuance and expire five years from the date of initial exercisability. The offering closed on October 28, 2024, and the Company received proceeds of approximately $15.0 million after payment of fees to the placement agent, but before payment of any additional expenses that will be incurred by the Company.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.