Item 8. Financial Statements and Supplementary Data
Item 8. Financial Statements and Supplementary Data
SENSEONICS HOLDINGS, INC. AND SUBSIDIARIES
Consolidated Financial Statements
Table of Contents
Report of KPMG LLP , Auditor ID: 185 , Independent Registered Public Accounting Firm
84
Consolidated Balance Sheets as of December 31, 2023 and 2022
85
Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2023 and 2022
86
Consolidated Statements of Changes in Stockholders’ Equity for the years ended December 31, 2023 and 2022
87
Consolidated Statements of Cash Flows for the years ended December 31, 2023 and 2022
88
Notes to Consolidated Financial Statements
89
83
Report of Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors
Senseonics Holdings, Inc.:
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheets of Senseonics Holdings, Inc. and subsidiary (the Company) as of December 31, 2023 and 2022, the related consolidated statement of operations and comprehensive (loss) income, stockholders’ equity (deficit), and cash flows for each of the years in the two-year period ended December 31, 2023, and the related notes (collectively, the consolidated financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the years in the two-year period ended December 31, 2023, in conformity with U.S. generally accepted accounting principles
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
Critical audit matters are matters arising from the current period audit of the consolidated financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there are no critical audit matters.
/s/ KPMG LLP
We have served as the Company’s auditor since 2022.
McLean, Virginia
February 29, 2024
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Senseonics Holdings, Inc.
Consolidated Balance Sheets
(in thousands, except for share and per share data)
December 31,
2023
2022
Assets
Current assets:
Cash and cash equivalents
$
75,709
$
35,793
Short term investments, net
33,747
108,222
Accounts receivable, net
808
127
Accounts receivable, net - related parties
3,724
2,324
Inventory, net
8,776
7,306
Prepaid expenses and other current assets
7,266
7,428
Total current assets
130,030
161,200
Deposits and other assets
7,006
3,108
Long term investments, net
—
12,253
Property and equipment, net
1,184
1,112
Total assets
$
138,220
$
177,673
Liabilities and Stockholders’ Equity (Deficit)
Current liabilities:
Accounts payable
$
4,568
$
419
Accrued expenses and other current liabilities
11,744
14,616
Accrued expenses and other current liabilities, related parties
945
837
Note payable, current portion, net
—
15,579
Derivative liability, current portion
—
20
Total current liabilities
17,257
31,471
Long-term debt and notes payables, net
41,195
56,383
Derivative liabilities
102
52,050
Other liabilities
6,214
2,689
Total liabilities
64,768
142,593
Commitments and contingencies
Preferred stock and additional paid-in-capital, subject to possible redemption: $ 0.001 par value per share; 12,000 shares and 12,000 shares issued and outstanding as of December 31, 2023 and December 31, 2022
37,656
37,656
Total temporary equity
37,656
37,656
Stockholders’ equity (deficit):
Common stock, $ 0.001 par value per share; 900,000,000 shares authorized as of December 31, 2023 and December 31, 2022; 530,364,237 shares and 479,637,138 shares issued and outstanding as of December 31, 2023 and December 31, 2022
530
480
Additional paid-in capital
904,535
806,488
Accumulated other comprehensive loss
( 11 )
( 678 )
Accumulated deficit
( 869,258 )
( 808,866 )
Total stockholders' equity (deficit)
35,796
( 2,576 )
Total liabilities, temporary equity and stockholders’ equity (deficit)
$
138,220
$
177,673
The accompanying notes are an integral part of these consolidated financial statements.
85
Senseonics Holdings, Inc.
Consolidated Statements of Operations and Comprehensive (Loss) Income
(in thousands, except for share and per share data)
Years Ended
December 31,
2023
2022
Revenue, net
$
1,655
$
656
Revenue, net - related parties
20,735
15,733
Total revenue
22,390
16,389
Cost of sales
19,299
13,663
Gross profit
3,091
2,726
Expenses:
Research and development expenses
48,752
39,719
Selling, general and administrative expenses
29,942
31,634
Operating loss
( 75,603 )
( 68,627 )
Other income (expense), net:
Interest income
5,362
1,824
Gain (Loss) on fair value adjustment of option
—
43,745
Exchange related gain, net
14,109
—
Gain (Loss) on extinguishment of debt and option
—
( 101 )
Interest expense
( 11,110 )
( 18,703 )
Gain (Loss) on change in fair value of derivatives
6,648
184,221
Impairment cost
—
( 138 )
Other income (expense)
202
( 102 )
Total other income, net
15,211
210,746
Net (Loss) Income
( 60,392 )
142,119
Other comprehensive income (loss)
Unrealized gain (loss) on marketable securities
667
( 466 )
Total other comprehensive gain (loss)
667
( 466 )
Total comprehensive (loss) income
$
( 59,725 )
$
141,653
Basic net (loss) income per common share
$
( 0.11 )
$
0.30
Basic weighted-average shares outstanding
567,974,492
467,952,475
Diluted net loss per common share
$
( 0.11 )
$
( 0.11 )
Diluted weighted-average shares outstanding
567,974,492
618,205,605
The accompanying notes are an integral part of these consolidated financial statements.
86
Senseonics Holdings, Inc.
Consolidated Statements of Changes in Stockholders’ Equity (Deficit)
(in thousands)
Series B
Additional
Accumulated
Total
Convertible
Common Stock
Paid-In
Other
Accumulated
Stockholders'
Preferred Stock
Shares
Amount
Capital
Comprehensive Loss
Deficit
Equtiy (Deficit)
Temporary Equity
Balance, December 31, 2021
447,282
$
447
$
765,215
$
( 212 )
$
( 950,985 )
$
( 185,535 )
—
Issuance of convertible preferred stock, net of issuance costs
—
—
—
—
—
—
37,656
Issuance of common stock, net of issuance costs
15,161
15
34,159
—
—
34,174
—
Exercise of stock options and warrants
9,892
10
941
—
—
951
—
Issuance of common stock for vested RSUs and ESPP purchases
9,507
10
123
—
—
133
—
Stock-based compensation expense
—
—
8,618
—
—
8,618
—
Shares withheld related to net share settlement of equity awards
( 2,205 )
( 2 )
( 2,568 )
( 2,570 )
Net income
—
—
—
—
142,119
142,119
—
Other comprehensive loss
—
—
—
( 466 )
—
( 466 )
—
Balance, December 31, 2022
479,637
$
480
$
806,488
$
( 678 )
$
( 808,866 )
$
( 2,576 )
$
37,656
Issuance of common stock, net of issuance costs
9,945
10
7,366
—
—
7,376
—
Issuance of warrants, net of issuance costs
—
—
63,645
—
63,645
Exercise of stock options and warrants
6
—
3
—
—
3
—
Exchange of 2025 Notes
35,139
35
20,967
—
—
21,002
Issuance of common stock for vested RSUs and ESPP purchases
9,531
9
198
—
—
207
—
Stock-based compensation expense
—
—
8,673
—
—
8,673
—
Shares withheld related to net share settlement of equity awards
( 3,894 )
( 4 )
( 2,668 )
—
—
( 2,672 )
—
Other
—
—
( 137 )
—
—
( 137 )
Net loss
—
—
—
—
( 60,392 )
( 60,392 )
—
Other comprehensive gain
—
—
—
667
—
667
—
Balance, December 31, 2023
530,364
$
530
$
904,535
$
( 11 )
$
( 869,258 )
$
35,796
37,656
The accompanying notes are an integral part of these consolidated financial statements.
87
Senseonics Holdings, Inc.
Consolidated Statements of Cash Flows
(in thousands)
Year Ended
December 31,
2023
2022
Cash flows from operating activities
Net (loss) income
$
( 60,392 )
$
142,119
Adjustments to reconcile net (loss) income to net cash used in operating activities:
Depreciation and ROU amortization expense
1,277
985
Non-cash interest expense
4,734
12,164
Change in fair value of derivatives
( 6,648 )
( 184,221 )
(Gain) Loss on fair value adjustment of option
—
( 43,745 )
(Gain) Loss on extinguishment of option
—
101
Exchange-related gain, net
( 14,109 )
—
Impairment of option
—
138
Stock-based compensation expense
8,673
8,618
Provision for inventory obsolescence
174
—
Loss on disposal of assets
5
—
Other
89
—
Changes in assets and liabilities:
Accounts receivable
( 2,191 )
( 478 )
Prepaid expenses and other current assets
162
( 1,210 )
Inventory
( 1,644 )
( 989 )
Deposits and other assets
( 438 )
381
Accounts payable
2,297
( 785 )
Accrued expenses and other liabilities
( 1,061 )
1,462
Accrued interest
31
( 95 )
Operating lease liabilities
( 1,122 )
( 757 )
Net cash used in operating activities
( 70,163 )
( 66,312 )
Cash flows from investing activities
Capital expenditures
( 350 )
( 312 )
Purchase of marketable securities
( 68,537 )
( 104,706 )
Proceeds from sale and maturity of marketable securities
158,600
131,900
Net cash provided by investing activities
89,713
26,882
Cash flows from financing activities
Proceeds from issuance of common stock, net of issuance costs
7,376
34,174
Proceeds from exercise of stock options and ESPP issuances, net
73
1,084
Taxes paid related to net share settlement of equity awards
( 2,672 )
( 2,570 )
Repayment of 2023 Notes
( 15,700 )
—
Repayment of 2025 Notes
( 7,500 )
—
Repayment of term loans
—
( 2,926 )
Proceeds from issuance of Loan and Security Agreement, net
24,446
—
Payment of debt issuance costs
( 355 )
—
Proceeds from issuance of warrants, net
14,698
—
Proceeds from issuance of preferred stock, net
—
12,000
Net cash provided by financing activities
20,366
41,762
Net increase in cash and cash equivalents
39,916
2,332
Cash and cash equivalents, at beginning of period
35,793
33,461
Cash and cash equivalents, at ending of period
$
75,709
$
35,793
Supplemental disclosure of cash flow information
Cash paid during the period for interest
$
3,678
$
6,568
Lease liabilities arising from obtaining right-of-use assets
3,831
2,689
Supplemental disclosure of non-cash investing and financing activities
Property and equipment purchases included in accounts payable and accrued expenses
173
—
Conversion of options into redeemable convertible preferred stock
—
25,656
Issuance of warrants in exchange for PHC Notes
48,564
—
Issuance of warrants for Loan and Security Agreement
364
—
Issuance of common stock converted from 2025 Notes
21,002
—
The accompanying notes are an integral part of these consolidated financial statements.
88
Senseonics Holdings, Inc.
Notes to Consolidated Financial Statements
1.
Organization
Senseonics Holdings, Inc., a Delaware corporation, is a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring system 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. Senseonics Holdings, Inc. and Senseonics, Incorporated are hereinafter collectively referred to as the “Company” unless otherwise indicated or the context otherwise requires.
2.
Liquidity and Capital Resources
The Company’s operations are subject to certain risks and uncertainties including, among others, current and potential competitors with greater resources, lack of operating history as a commercial-stage company and uncertainty of future profitability. Since inception, the Company has suffered substantial operating losses, principally from expenses associated with the Company’s research and development programs and commercial launch of the Eversense® E3 CGM System (for use up to six months ) in both the United States and Europe, and the launch of our legacy versions, including Eversense CGM System in the United States (for use up to 90 days ) and the Eversense CGM and Eversense XL CGM Systems (for use up to six months ) in Europe, the Middle East, and Africa.
The Company has not generated significant profit from the sale of products and its ability to generate revenue and achieve profitability largely depends on the Company’s ability to successfully expand the commercialization of Eversense, continue the development of its products and product upgrades, and to obtain necessary regulatory approvals or certifications for the sale of those products. These activities will require significant uses of working capital through 2024 and beyond. The Company generated total gross profit of $ 3.1 million for the twelve months ended December 31, 2023 and had an accumulated deficit of $ 869.3 million at December 31, 2023. To date, the Company has funded its operations principally through the issuance of preferred stock, common stock, convertible note issuance and debt. As of December 31, 2023, the Company had cash, cash equivalents and marketable securities of $ 109.5 million.
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, 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”).
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
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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. 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. As of December 31, 2023, no sales have been made under the Equity Distribution Agreement.
In November 2021, the Company entered into an Open Market Sale Agreement (the “2021 Sales Agreement”) with Jefferies LLC (“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. For the twelve months ending December 31, 2023 and 2022, the Company received $ 7.4 million and $ 34.2 million in net proceeds from the sale of 9,944,663 shares and 15,160,899 shares of its common stock under the 2021 Sales Agreement, respectively. 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 November 9, 2020, the Company entered into an Equity Line Agreement (the “Equity Line Agreement”) with Energy Capital, LLC, a Florida limited liability company (“Energy Capital”), which provided that, upon the terms and subject to the conditions and limitations set forth therein, Energy Capital was committed to purchase up to an aggregate of $ 12.0 million of shares of the Company’s newly designated series B convertible preferred stock (the “Series B Preferred Stock”) at the Company’s request from time to time during the 24-month term of the Equity Line Agreement. Under the Equity Line Agreement, beginning January 21, 2021, subject to the satisfaction of certain conditions, including that the Company have less than $ 8.0 million of cash, cash equivalents and other available credit (aside from availability under the Equity Line Agreement), the Company had the right, at its sole discretion, to present Energy Capital with a purchase notice (each, a “Regular Purchase Notice”) directing Energy Capital (as principal) to purchase shares of Series B Preferred Stock at a price of $ 1,000 per share (not to exceed $ 4.0 million worth of shares) once per month, up to an aggregate of $ 12.0 million of the Company’s Series B Preferred Stock at a per share price (the “Purchase Price”) equal to $ 1,000 per share of Series B Preferred Stock, with each share of Series B Preferred Stock initially convertible into common stock, beginning six months after the date of its issuance, at a conversion price of $ 0.3951 per share, subject to customary anti-dilution adjustments, including in the event of any stock split. The Equity Line Agreement provided that the Company was not permitted to affect any Regular Purchase Notice under the Equity Line Agreement on any date where the closing price of the Company’s common stock on the NYSE American is less than $ 0.25 without the approval of Energy Capital. In addition, beginning on January 1, 2022, since there had been no sales of the Series B Preferred Stock pursuant to the Equity Line Agreement, Energy Capital had the right, at its sole discretion, by its delivery to the Company of a Regular Purchase Notice, to purchase up to the $ 12.0 million of Series B Preferred Stock under the Equity Line Agreement at the Purchase Price. On November 7, 2022, Energy Capital exercised in full its right to purchase $ 12.0 million of shares of Series B Preferred Stock. The excess of the Purchase Price and the fair value of the Energy Capital option in the total amount of $ 37.6 million was recorded in additional-paid-in-capital as convertible preferred stock.
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 has 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
90
February 2022 and the option was not exercised. As described in Note 13, 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, 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.
The Company believes that these agreements provide the financial resources and mutual commitment to support the growth of the new Eversense E3 product and subsequent product versions. The timing and success of these collaborations and financings are dependent on certain events occurring in accordance with the Company’s plans, and may be influenced by uncontrollable external factors. Management has concluded that based on the Company’s current operating plans, its existing cash and cash equivalents will be sufficient to meet the Company’s anticipated operating needs through twelve months after issuance of the financial statements.
3.
Summary of Significant Accounting Policies
Basis of Presentation
The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). The consolidated financial statements reflect the accounts of Senseonics Holdings and its wholly owned operating subsidiary Senseonics, Incorporated. All intercompany balances and transactions have been eliminated in consolidation. The Company views its operations and manages its business in one segment, glucose monitoring products. 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.
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 consolidated financial statements, estimates are used for, but not limited to, stock-based compensation, recoverability of long-lived assets, deferred taxes and valuation allowances, 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.
91
Cash and Cash Equivalents and Concentration of Credit Risk
The Company considers highly liquid investments with original maturities of three months or less from the date of purchase to be cash equivalents. These investments are carried at cost, which approximates fair value. Cash, cash equivalents and restricted cash consisted of the following (in thousands):
December 31,
December 31,
2023
2022
Cash ⁽ ¹ ⁾
$
2,756
$
1,135
Money market funds
72,953
34,658
Cash and cash equivalents
$
75,709
$
35,793
(1) Includes overnight repurchase agreements.
There was no restricted cash held as of December 31, 2023 and December 31, 2022.
Marketable Securities
Marketable securities consist of commercial paper, corporate debt securities, asset backed securities and government and agency securities. The Company’s investments are classified as available for sale. Such securities are carried at fair value, with any unrealized holding gains or losses reported, net of any tax effects reported, as accumulated other comprehensive income. Realized gains and losses and declines in value judged to be other-than-temporary, if any, are included in consolidated results of operations. A decline in the market value of any available for sale security below cost that is deemed to be other-than-temporary results in a reduction in fair value, which is charged to earnings in that period, and a new cost basis for the security is established. Dividend and interest income is recognized when earned. The cost of securities sold is calculated using the specific identification method. We classify all available-for-sale marketable securities with maturities greater than one year from the balance sheet date as non-current assets. We do not generally intend to sell these investments and it is not more likely than not that we will be required to sell the investments before recovery of their amortized cost bases, which may be at maturity.
Inventory and Obsolescence
Inventory is valued at the lower of cost or net realizable value. Cost is determined using the standard cost method that approximates first in, first out. The Company records an adjustment to reduce the value of inventory for items that are potentially obsolete, where standard costs require adjustment to the net realizable value, and are in excess of future demand taking into consideration the product shelf life. The sensor manufacturing process can span several months, involves various contract manufacturers and includes raw components with long lead times, often resulting in significant work-in-progress inventory. However, expiry does not commence until the chemistry is applied to the sensor. The Company is able to isolate pre-chemistry sensor inventory in progress from post-chemistry sensor inventory in progress and finished goods to assess against demand forecasts and customer dating requirements for potential excess or obsolete inventory. The Company’s estimates are based on information known as of the balance sheet date and include factors such as anticipated future usage and sales, potential for external unfavorable conditions such as import holds or quality issues, and planned product upgrades. However, if actual product quality or conditions differ from the Company’s assumptions, additional inventory adjustments that would increase cost of sales could be required.
Accounts Receivable
The Company grants credit to various customers in the normal course of business. Accounts receivable consist of amounts due from distributors and are reduced by an allowance for doubtful accounts at the time potential collection risk is identified. Uncollectible accounts are written off against the allowance after appropriate collection efforts have been exhausted and when it is deemed that a balance is uncollectible. The Company does not have a history of collectability concerns, and the allowance for uncollectible accounts was $ 0.1 million as of December 31, 2023. There was no allowance recorded as of December 31, 2022.
92
Property and Equipment, net
Property and equipment are stated at cost and depreciated using the straight-line method over the estimated useful lives of the assets, which is generally between three to seven years , and is recorded within operating expenses and cost of goods sold in the consolidated statements of operations and comprehensive loss. Upon disposition of the assets, the costs and related accumulated depreciation are removed from the accounts and any resulting gain or loss is included in the results of operations. Repairs and maintenance costs are included as expense in the accompanying statement of operations.
Leases
The Company evaluates whether contractual arrangements contain leases at the inception of such arrangements. Specific considerations include whether the Company can control the underlying asset and has the right to obtain substantially all of the economic benefits or outputs from the asset. Substantially all of the Company’s leases are long-term operating leases with fixed payment terms. The Company currently does not have financing leases. Right-of-use (“ROU”) operating lease assets represent the Company’s right-to-use an underlying asset for the lease term, and operating lease liabilities represent the Company’s obligation to make lease payments. Operating lease expense is recognized on a straight-line basis over the lease term and is included in general and administrative expenses on the Company’s consolidated statement of operations and comprehensive loss. Options to extend the leases or terminate the leases early are only included in the lease term when it is reasonably certain that the option will be exercised.
The Company recognizes a ROU lease asset and liability as of the lease commencement date at the present value of the lease payments over the lease term. If the discount rate in the lease agreement is not implicit, the Company estimates the incremental borrowing rate based on the rate of interest the Company would have to pay to borrow a similar amount on a collateralized basis over a similar term. Lease and non-lease components are accounted for as a single component for facility leases. Leases with an initial term of 12 months or less are expensed to rent expense over the related term.
Impairment of Long-lived Assets
Management reviews long-lived assets, including property and equipment and right-of-use assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of the long-lived asset is measured by a comparison of the carrying amount of the asset to future undiscounted net cash flows expected to be generated by the asset. If the undiscounted cash flows are less than the carrying amount, the impairment to be recognized is measured by the amount by which the carrying amount of the assets exceeds the estimated fair value of the assets. There were no impairment indicators identified in 2023 or 2022.
Derivative Financial Instruments
The Company accounts for conversion options embedded in convertible notes in accordance with ASC Topic 815, Derivatives and Hedging. ASC Topic 815 generally requires companies to bifurcate conversion options embedded in convertible notes from their host instruments and to account for them as free standing derivative financial instruments. We review the terms of convertible debt issues to determine whether there are embedded derivative instruments, including embedded conversion options, which are required to be bifurcated and accounted for separately as derivative financial instruments. In circumstances where the host instrument contains more than one embedded derivative instrument, including the conversion option, that is required to be bifurcated, the bifurcated derivative instruments are accounted for as separate derivative instruments.
The fair value of the embedded features are accounted for as a derivative liability in the Company’s consolidated balance sheets and adjusted to fair value each reporting period. The change in fair value of derivatives is recorded as a component of other income (expense) in the Company’s consolidated statements of operations and comprehensive loss.
93
Product Warranty Obligations
The Company provides a warranty of one 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 return management authorizations to revenue.
At December 31, 2023 and December 31, 2022, the warranty reserve was $ 0.5 million and $ 0.8 million, respectively. The following table provides a reconciliation of the change in estimated warranty liabilities for the years ended December 31, 2023 and 2022 (in thousands):
December 31,
December 31,
2023
2022
Balance at beginning of the period
$
781
$
723
Provision for warranties during the period
242
166
Settlements made during the period
( 509 )
( 108 )
Balance at end of the period
$
514
$
781
Revenue Recognition
We generate the majority of our product revenue from sales of the Eversense system and related components and supplies to Ascensia, through the Commercialization Agreement, third-party distributors in the European Union and to strategic fulfillment partners in the United States (collectively “Customers”), who then resell the products to health care providers and patients. We are paid for our sales directly to the Customers, regardless of whether or not the Customers resell the products to health care providers and patients.
Revenue from product sales is recognized at a point in time when the Customers obtain control of our product based upon the delivery terms as defined in the contract at an amount that reflects the consideration which we expect to receive in exchange for the product. Contracts with our distributors contain performance obligations, mostly for the supply of goods, and is typically satisfied upon transfer of control of the product. Customer contracts do not include the right to return unless there is a product issue, in which case we may provide replacement product. Product conformity guarantees do not create additional performance obligations and are accounted for as warranty obligations in accordance with guarantee and loss contingency accounting guidance.
In addition, we sell small quantities of our products directly to healthcare provider locations within the United States. In these direct sales, inventory is purchased on consignment to ensure availability when a patient is identified. No revenue is recognized upon delivery of our products to the healthcare provider locations, as we retain the ability to control the inventory. Rather, revenue is recognized when the product is consumed.
Our contracts may contain some form of variable consideration such as prompt-pay discounts, tier-volume price discounts and for the Commercialization Agreement, revenue share. Variable consideration, such as discounts and prompt-pay incentives, are treated as a reduction in revenue and variable considerations, such as revenue share, is treated as an addition in revenue when the product sale is recognized. The amount of variable consideration that is included in the transaction price may be constrained and is included in revenue only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period, when the uncertainty associated with the variable consideration is subsequently resolved. Estimating variable consideration and the related constraint requires the use of management judgment. Depending on the variable consideration, we develop estimates for the expected value based on the terms of the agreements, historical data, geographic mix, reimbursement rates and market conditions.
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 Commercialization Agreement.
94
Cost of Sales
The Company uses third-party contract manufacturers to manufacture Eversense and related components and supplies. Cost of sales includes raw materials, contract manufacturing service fees, expected warranty costs, recall costs, product obsolescence, scrap, third-party warehousing, shipping and handling expenses associated with product delivery, and employee-related costs of the internal supply chain and manufacturing team.
Research and Development Expenses
Research and development expenses consist of expenses incurred in performing research and development activities in developing Eversense, including clinical trials and feasibility studies, and partnerships for strategic initiatives including insulin delivery and new indications. Research and development expenses include compensation and benefits for research and development employees including stock-based compensation, cost of laboratory supplies, clinical trial and related clinical manufacturing expenses, costs related to regulatory operations, fees paid to contract research organizations and other consultants, and other outside expenses. Research and development expenses are expensed as incurred.
Selling, General and Administrative Expenses
Selling, general and administrative expenses consist primarily of salaries, commissions, and other related costs, including stock-based compensation, for personnel in the Company’s sales and marketing, executive, finance, accounting, business development, information technology, and human resources functions. Other significant costs include information technology, website design and advertising, educational and promotional materials, tradeshow expenses, marketing programs, facility costs, legal fees relating to patent and corporate matters, and fees for accounting and consulting services.
Stock-Based Compensation
The Company accounts for stock-based compensation related to stock option grants and restricted stock units under stock incentive plans, purchases under the employee stock purchase plan, as well as inducement stock grants, based on the fair value of those awards at the date of grant. The estimated fair value of stock options on the date of grant is amortized on a straight-line basis over the requisite service period of the individual award, which typically equals the vesting period. Forfeitures are accounted for in the period in which they occur.
The Company uses the Black-Scholes-Merton option pricing model (“Black-Scholes Model”) to determine the fair value of stock-option awards. Valuation of stock awards requires management to make assumptions and to apply judgment to determine the fair value of the awards. These assumptions and judgments include estimating the fair value of the Company’s common stock, the risk-free interest rate, future volatility of the Company’s stock price, dividend yields, and the expected life of the stock-option awards. Changes in these assumptions can affect the fair value estimate.
The risk-free interest rate assumption is based on observed interest rates for constant maturity U.S. Treasury securities consistent with the expected life of employee stock options. The expected life represents the period of time the stock options are expected to be outstanding and is based on the simplified method. Under the simplified method, the expected life of an option is presumed to be the mid-point between the vesting date and the end of the contractual term. The Company uses the simplified method due to the lack of sufficient historical exercise data to provide a reasonable basis upon which to otherwise estimate the expected life of the stock options. Expected volatility is based on the daily closing prices of the Company as well as the daily closing prices of a peer group of comparable publicly traded companies in similar stages of development. The Company has assumed no dividend yield because it does not expect to pay dividends in the future, which is consistent with its history of not paying dividends.
95
Income Taxes
The Company uses the asset and liability method of accounting for income taxes. Deferred tax assets and liabilities are determined based on differences between the financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that are in effect when the differences are expected to reverse. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the period that such tax rate changes are enacted. The measurement of a deferred tax asset is reduced, if necessary, by a valuation allowance if it is more likely than not that some portion or all of the deferred tax asset will not be realized.
Management uses a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return, as well as guidance on derecognition, classification, interest and penalties and financial statement reporting disclosures. For those benefits to be recognized, a tax position must be more-likely-than-not to be sustained upon examination by taxing authorities. In the ordinary course of business, transactions occur for which the ultimate outcome may be uncertain. Management does not expect the outcome related to accrued uncertain tax provisions to have a material adverse effect on the Company’s financial position, results of operations or cash flows. The Company recognizes interest and penalties accrued on any unrecognized tax exposures as a component of income tax expense.
The Company is subject to taxation in various jurisdictions in the United States and remains subject to examination by taxing jurisdictions for the year 2003 and all subsequent periods due to the availability of NOL and tax credit carryforwards. In addition, all of the net operating losses and research and development credit carryforwards that may be used in future years are still subject to adjustment.
Fair Value of Financial Instruments
The carrying amounts of cash, cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate fair value because of their short maturities. The Company’s term loan under the 2025 Notes, Loan and Security Agreement and warrants are recorded at historical cost, net of discounts. The associated embedded conversion features in the Notes are derivative instruments and along with Options are remeasured at fair value each reporting period.
Recent Accounting Pronouncements
In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses: Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”), which requires entities to record expected credit losses for certain financial instruments, including trade receivables, as an allowance that reflects the entity's current estimate of credit losses expected to be incurred. For available-for-sale debt securities in unrealized loss positions, the new standard requires allowances to be recorded instead of reducing the amortized cost of the investment. The Company currently holds investments in available-for sale securities. The Company has not historically experienced collection issues or bad debts with trade receivables. Accordingly, the Company does not expect this to have a significant impact on its consolidated financial statements and related disclosures at this time. The Company adopted this guidance as of January 1, 2023 and its adoption did not have a material impact on the consolidated financial statements and related disclosures.
96
4. Revenue Recognition
Revenues by geographic region
The following table sets forth net revenues derived from the Company’s two 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 years ended December 31, 2023 and 2022:
December 31, 2023
December 31, 2022
%
%
(Dollars in thousands)
Amount
of Total
Amount
of Total
Revenue, net:
United States
$
14,053
62.8
%
$
7,512
45.8
%
Outside of the United States
8,337
37.2
8,877
54.2
Total
$
22,390
100.0
%
$
16,389
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 December 31, 2023 and 2022 included unbilled accounts receivable of $ 1.5 million and $ 1.7 million, respectively. The Company expects to invoice and collect all unbilled accounts receivable within 12 months.
Concentration of Revenues and Customers
Net revenue from the Company’s distribution arrangement with Ascensia, a related party, accounted for 93 %, and 96 % of total net revenues for the years ended December 31, 2023 and 2022, respectively.
5. Net Income (Loss) per Share
Basic net income (loss) per share attributable to common stockholders is calculated by dividing the net income (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 income (loss) per share for the year ended December 31, 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 income (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.
97
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.
2023
2022
Net (loss) income
( 60,392 )
142,119
Impact of conversion of dilutive securities
—
( 209,269 )
Dilutive Net loss
( 60,392 )
( 67,150 )
Net (loss) income per share
Basic
( 0.11 )
0.30
Diluted
( 0.11 )
( 0.11 )
Basic weighted average shares outstanding
567,974,492
467,952,475
Dilutive potential common stock outstanding
Stock-based awards
—
6,000,572
2023 Notes
—
4,617,646
2025 Notes
—
39,689,142
PHC Notes
—
67,162,375
Series B Preferred Stock
—
30,372,058
Warrants
—
2,411,337
Diluted weighted average shares outstanding
567,974,492
618,205,605
Outstanding anti-dilutive securities not included in the diluted net income per share calculations were as follows:
2023
2022
Stock-based awards
27,609,566
11,917,529
2023 Notes
—
—
2025 Notes
15,813,176
—
PHC Notes
—
—
Series B Preferred Stock
30,372,058
—
Warrants
1,260,183
427,821
Total anti-dilutive shares outstanding
75,054,983
12,345,350
98
6.
Marketable Securities
Marketable securities available for sale, were as follows (in thousands):
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
December 31, 2022
Gross
Gross
Estimated
Amortized
Unrealized
Unrealized
Market
Cost
Gains
Losses
Value
Commercial Paper
$
41,503
—
—
$
41,503
Corporate debt securities
$
32,331
—
( 189 )
$
32,142
Asset backed securities
$
8,363
—
( 103 )
$
8,260
Government and agency securities
$
38,956
—
( 386 )
$
38,570
Total
$
121,153
$
—
$
( 678 )
$
120,475
The following are the scheduled maturities as of December 31, 2023 (in thousands):
Net
Fair
Carrying Amount
Value
2024
$
33,758
$
33,747
Total
$
33,758
$
33,747
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 December 31, 2023 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 we will be required to sell the investments before recovery of their amortized cost bases, which may be at maturity.
7.
Inventory, net
Inventory, net consisted of the following (in thousands):
December 31,
2023
2022
Finished goods
$
2,160
$
1,697
Work-in-process
5,332
4,057
Raw materials
1,284
1,552
Total
$
8,776
$
7,306
99
The Company recorded $ 0.2 million and $ 1.4 million in cost of sales for the years ended December 31, 2023 and 2022, respectively, to reduce the value of inventory for items that are potentially obsolete, to adjust costs to their net realizable value, and for inventory in excess of product demand.
8.
Prepaid expenses and other current assets
Prepaid expenses and other current assets consisted of the following as of December 31, 2023 and 2022 (in thousands):
December 31,
2023
2022
Contract manufacturing⁽¹⁾
$
4,244
$
4,097
Tax credits receivable (2)
1,793
—
Clinical and Preclinical
343
924
Interest receivable
272
336
IT and software
242
189
Rent and utilities
122
132
Research and development
95
67
Insurance
73
1,243
Accounting and Audit
61
270
Sales and Marketing
20
158
Other
1
12
Total prepaid expenses and other current assets
$
7,266
$
7,428
(1)
Includes deposits to contract manufacturers for manufacturing process
(2)
Refundable employee retention credits, enacted under the CARES Act.
9. Property and Equipment, net
Property and equipment, net consisted of the following as of December 31, 2023 and 2022 (in thousands):
December 31,
2023
2022
Machinery and laboratory equipment
$
2,783
$
2,668
Office furniture and equipment
354
354
Leasehold improvements
530
128
3,667
3,150
Less: Accumulated depreciation
( 2,483 )
( 2,038 )
Property and equipment, net
$
1,184
$
1,112
Depreciation expense for the years ended December 31, 2023 and 2022 was $ 0.4 million and $ 0.5 million, respectively. There were no material disposals during 2023 or 2022.
100
10.
Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following as of December 31, 2023 and 2022 (in thousands):
December 31,
2023
2022
Compensation and benefits
$
4,799
$
4,699
Research and development
3,846
3,502
Contract manufacturing
1,457
2,480
Interest on notes payable
704
2,050
Professional and administration services
673
1,053
Product warranty and replacement obligations
514
781
Operating lease
368
725
Sales and marketing services
301
149
Other
27
14
Total accrued expenses and other current liabilities
$
12,689
$
15,453
11.
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 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 has one option to extend the term for an additional period of five 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.
On July 31, 2019, the Company entered into a non-cancellable operating lease agreement for approximately 30,500 square feet of office space commencing on September 2, 2019 and expiring in 2023. The Company did not have any lease related payments made to the lessor before the commitment date, lease incentives received from the lessor or initial direct cost adjustments to be added to the initial measurement of the liability. This facility was decommissioned in 2021 and an impairment charge of $ 0.5 million was recorded. The Company continued to make lease payments through the lease expiration date.
Operating lease expense for the years ended December 31, 2023 and 2022 was $ 0.8 million and 0.7 million, respectively.
The following table summarizes the lease assets and liabilities as of December 31, 2023 and 2022 (in thousands):
December 31,
Operating Lease Assets and Liabilities
Balance Sheet Classification
2023
2022
Assets
Operating lease ROU assets
Deposits and other assets
$
5,180
3,032
Liabilities
Current operating lease liabilities
Accrued expenses and other current liabilities
$
368
725
Non-current operating lease liabilities
Other non-current liabilities
6,214
2,689
Total operating lease liabilities
$
6,582
3,414
101
The following table summarizes the maturity of undiscounted payments due under operating lease liabilities and the present value of those liabilities as of December 31, 2023 (in thousands):
2024
912
2025
939
2026
967
2027
996
2028
1,026
Threafter
4,908
Total
9,748
Present value adjustment
( 3,166 )
Present value of lease liabilities
$
6,582
The following table summarizes the weighted-average lease term and weighted-average discount rate as of December 31, 2023 and 2022:
Remaining lease term (years)
2023
2022
Operating leases
9.4
5.0
Discount rate
Operating leases
8.5
%
9.1
%
During the years ended December 31, 2023 and 2022, the Company made cash payments of $ 1.1 million and $ 1.0 million included in the measurement of its operating lease liabilities, respectively.
12.
401(k) Plan
The Company has a defined contribution 401(k) plan available to all full-time employees. Employee contributions are voluntary and are determined on an individual basis subject to the maximum allowable under federal income tax regulations. Participants are fully vested in their contributions. The Company has provided a discretionary match of up to 3 % of the participant’s contributions. Employer match expenses during the years ended December 31, 2023 and 2022 were $ 0.5 million and $ 0.4 million, respectively. Administrative expenses for the plan, which are paid by the Company, were not material in 2023 or 2022.
13.
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”).
102
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 outstanding loan amount 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, subject to certain exceptions.
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 “Tranche 1 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 “Tranche 1 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 Tranche 1 Warrants. The number of Tranche 1 Warrant Shares for which the Tranche 1 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 Tranche 1 Warrants. The proceeds from the Loan and Security Agreement were allocated between the Tranche 1 Loan and the Tranche 1 Warrants based on their respective fair value of $ 25.0 million and $ 0.4 million, and the amount allocated to the Tranche 1 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 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”).
103
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 13.17 %. The fair value of the Company’s Loan and Security Agreement was $ 26.2 million as of December 31, 2023.
Pursuant to the Loan and Security Agreement, the Company also agreed to issue additional seven year term warrants upon the funding of the Tranche 2 Loan and 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 the three-day volume-weighted average price at the time of the advance.
PPP Loan
On April 22, 2020, the Company received $ 5.8 million in loan funding from the PPP pursuant to the CARES Act, as amended by the Flexibility Act, and administered by the Small Business Administration (“SBA”). The unsecured loan (the “PPP Loan”) is evidenced by the PPP Note dated April 21, 2020 (the “PPP Note”) in the principal amount of $ 5.8 million with Silicon Valley Bank (“SVB.”)
Under the terms of the PPP Note and the PPP Loan, interest accrued on the outstanding principal at a rate of 1.0 % per annum. The term of the PPP Note was two years . In April 2022, the Company repaid the outstanding principal and accrued interest in full.
Convertible Preferred Stock and Warrants
Equity Line Agreement
On November 9, 2020, the Company entered into an equity line agreement with Energy Capital, which provides that, upon the terms and subject to the conditions and limitations set forth therein, Energy Capital was committed to purchase up to an aggregate of $ 12.0 million of shares of the Company’s newly designated Series B Preferred Stock at the Company’s request from time to time during the 24-month term of the Equity Line Agreement. Under the Equity Line Agreement, beginning January 21, 2021, subject to the satisfaction of certain conditions, the Company had the right, at sole discretion, to present Energy Capital with a Regular Purchase Notice directing Energy Capital (as principal) to purchase shares of Series B Preferred Stock at a price of $ 1,000 per share (not to exceed $ 4.0 million worth of shares) once per month, up to an aggregate of $ 12.0 million of our Series B Preferred Stock at the Purchase Price equal to $ 1,000 per share of Series B Preferred Stock, with each share of Series B Preferred Stock initially convertible into common stock, beginning six months after the date of its issuance, at a conversion price of $ 0.3951 per share, subject to customary anti-dilution adjustments, including in the event of any stock split. The Equity Line Agreement provided that we shall not affect any Regular Purchase Notice under the Equity Line Agreement on any date where the closing price of the Company’s common stock on the NYSE American is less than $ 0.25 without the approval of Energy Capital. In addition, beginning on January 1, 2022, since there have been no sales of the Series B Preferred Stock pursuant to the Equity Line Agreement, Energy Capital had the right, at its sole discretion, by its delivery to the Company of a Purchase Notice, to purchase up to $ 12.0 million of Series B Preferred Stock under the Equity Line Agreement at the Purchase Price. On November 7, 2022, Energy Capital exercised in full its right to purchase $ 12.0 million of Series B Preferred Stock.
The Company accounted for the Equity Line Agreement as a put/call option (the “Energy Capital Option”). This put/call option was classified as a liability in accordance with ASC 480 on the Company’s balance sheet and was recorded at the estimated fair value of $ 4.2 million upon issuance. In connection with the issuance of the Equity Line Agreement, the Company incurred and expensed $ 7.6 million in debt issuance costs in fiscal year 2020. The put/call option was required to be remeasured to fair value at each reporting period with the change recorded in change in fair value of derivatives that is a component of other income (expense). The fair value of the Energy Capital Option as of December 31, 2021 was $ 69.4 million. The Company adjusted the Energy Capital Option to its fair value of $ 25.7 million on the exercise date, recognizing a fair value adjustment gain of $ 43.7 million.
Concurrently with entry into the Equity Line Agreement, the Company issued a warrant to Energy Capital,
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exercisable beginning on May 9, 2021, to purchase up to 10,000,000 shares of common stock at an exercise price of $ 0.3951 per share (the “Warrant”). The Warrant was exercised on a net basis in February 2022 and Energy Capital received 8,917,535 shares of common stock upon the net exercise of the 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 shall 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. At 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 December 31, 2023, 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 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
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financing fee (the “Financing Fee Shares”) on the Closing Date. The Financing Fee Shares were recorded 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 annual rate of 9.5 % was 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 E3 Eversense system for marketing in the United States. The maturity date for the PHC Notes is 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 occur prior to the maturity date, the Company would have been required, in certain circumstances, to increase the conversion rate for a holder who elects to convert its PHC Notes in connection with such notice of redemption or corporate event. In certain circumstances, 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 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 been 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 has 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 be 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 E3 product for marketing in the United States before such date, and which the Company successfully obtained in February 2022. The Company developed an estimated fair value at December 31, 2021 to be $ 0.2 million, and an impairment loss of $ 1.6 million was recognized in net income as the difference between the fair value of the investment and its carrying amount. 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. 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 Topic 815, Derivatives and Hedging. The derivative is adjusted to fair value at each reporting
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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 Note Purchase Agreement, 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 are deferred and amortized as additional interest expense over the term of the notes at an effective interest rate of 29.19 %. There were no conversions of the PHC Notes prior to the exchange of the PHC Notes for the PHC Exchage 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 (loss), 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 2025 Notes. The 2025 Notes are general, unsecured, senior subordinated obligations of the Company and bear interest at a rate of 5.25 % per year, payable semiannually in arrears on January 15 and July 15 of each year, beginning on January 15, 2020. The 2025 Notes will mature on January 15, 2025, unless earlier repurchased or converted.
The Company used $ 37.9 million of the net proceeds from the issuance of the 2025 Notes to repurchase $ 37.0 million aggregate principal amount of the Company’s outstanding 2023 Notes, at a purchase price equal to the principal amount thereof, plus accrued and unpaid interest thereon.
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 Company may redeem for cash all or part of the 2025 Notes, at its option, if (1) the last reported sale price of the Company’s common stock has been at least 150 % of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which the Company provides notice of redemption and (2) a registration statement covering the resale of the shares of the Company’s common stock issuable upon conversion of the 2025 Notes is effective and available for use and is expected to remain effective and available for use during the redemption period as of the date of the redemption notice date. The redemption price will be equal to 100 % of the principal amount of the 2025 Notes to be redeemed plus accrued and unpaid interest to, but excluding, the redemption date.
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If the Company undergoes a fundamental change, such as a merger, sale, greater than 50% ownership change, liquidation, dissolution or delisting, holders may require the Company to repurchase for cash all or any portion of their 2025 Notes at a fundamental change repurchase price equal to 100 % of the principal amount of the 2025 Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. In addition, following a notice of redemption or certain corporate events that occur prior to the maturity date, the Company will, in certain circumstances, increase the conversion rate for a holder who elects to convert its 2025 Notes in connection with such notice of redemption or corporate event. In certain circumstances, the Company will be required to pay cash in lieu of delivering make whole shares unless the Company obtains stockholder approval to issue shares.
The 2025 Notes are guaranteed on a senior unsecured basis by the Company’s wholly owned subsidiary, Senseonics, Incorporated, and may be guaranteed by certain future subsidiaries. The subsidiary guarantor is 100 % owned, the guarantee is full and unconditional and joint and several and the parent company has no independent assets or operations and any subsidiaries of the parent company other than the subsidiary guarantor are minor.
In connection with the issuance of the 2025 Notes, the Company incurred $ 4.3 million in debt issuance costs and debt discounts. Several note holders of the 2025 Notes were also note holders of the 2023 Notes, and as a result, these transactions qualified as loan modifications. The associated debt issuance costs were allocated between the portion of 2025 Notes purchased by new note holders, and of 2025 Notes purchased by existing 2023 Note holders. Loan modifications require third-party debt related costs to be expensed immediately, whereas fees paid to lenders of the modified loans are deferred. The third-party costs associated with the new note holders are also deferred as discounts that are amortized as additional interest expense over the term of the notes. Of the $ 4.3 million, $ 3.3 million were expensed for loan modifications were recorded within other income (expense) on the consolidated statement of operations and comprehensive loss and $ 1.0 million were deferred as discounts to the debt in 2019.
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 Company recorded the fair value of the embedded features in the amount of $ 38.3 million as a debt discount and derivative liability in the Company’s consolidated balance sheets in accordance with ASC Topic 815, Derivatives and Hedging . 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.
The 2025 Notes do not have current observable inputs such as recent trading prices (Level 3) and are measured at fair value using the binomial option pricing model and incorporate management’s assumptions for probabilities of conversion occurrence through maturity, stock price, volatility, risky (bond) rate, credit spread and recovery rates.
On April 21, 2020, $ 24.0 million in principal on the 2025 Notes were settled pursuant to an exchange agreement. Between September 3, 2020 and January 27, 2021, $ 6.8 million in aggregate principal on the 2025 Notes were converted into 5,152,259 shares of common stock.
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
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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 Company’s 2025 Notes, excluding the embedded features, was $ 19.1 million as of December 31, 2023 and $ 41.3 million at December 31, 2022. The fair value of the derivative at December 31, 2023 and December 31, 2022 was $ 0.1 million and $ 7.9 million, respectively.
2023 Notes
In January 2018, the Company issued $ 50.0 million in aggregate principal amount of the 2023 Notes. In February 2018, the Company issued an additional $ 3.0 million in aggregate principal amount of the 2023 Notes, pursuant to the partial exercise of the overallotment option by the underwriter. The 2023 Notes were general, unsecured, senior subordinated obligations and bear interest at a rate of 5.25 % per year, payable semiannually in arrears on February 1 and August 1 of each year. The net proceeds from the issuance of the 2023 Notes, after deducting transaction costs, were $ 50.7 million. The Company paid interest semiannually in arrears on February 1 and August 1 of each year, beginning on August 1, 2018. 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 were 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 were amortized to interest expense over the term of the 2023 Notes at an effective interest rate of 9.30 %. The derivative was 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 are outstanding under the Company’s notes payable as of December 31, 2023 and December 31, 2022 (in thousands):
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
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December 31, 2022
Principal ($)
Debt (Discount) Premium ($) 1
Issuance Costs ($)
Carrying Amount ($)
2023 Notes
15,700
( 121 )
—
15,579
2025 Notes
51,199
( 15,029 )
( 252 )
35,918
PHC Convertible Notes
35,000
( 13,698 )
( 837 )
20,465
(1)
Includes accretion of end of term fees payable at maturity
Interest expense related to the notes payable for the periods presented below is as follows (in thousands):
Twelve Months Ended December 31, 2023
Interest Rate
Interest ($)
Debt Discount & Fees ($) 1
Issuance Costs ($)
Total Interest Expense ($)
2023 Notes
5.25 %
69
121
—
189
2025 Notes
5.25 %
2,149
5,451
91
7,691
PHC Convertible Notes
8.00 %
700
1,442
88
2,230
Loan and Security Agreement
9.90 %
791
184
24
999
Total
3,709
7,198
203
11,110
Twelve Months Ended December 31, 2022
Interest Rate
Interest ($)
Debt Discount & Fees ($) 1
Issuance Costs ($)
Total Interest Expense ($)
2023 Notes
5.25 %
824
1,378
—
2,202
2025 Notes
5.25 %
2,674
5,506
92
8,272
PHC Convertible Notes
8.00 %
3,035
4,889
299
8,223
PPP Loan
1.00 %
6
—
—
6
Total
6,539
11,773
391
18,703
(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 December 31, 2023:
2025
$
20,399
2026
7,397
2027
19,341
Total
$
47,137
14.
Stockholders’ Deficit
In connection with the Company’s acquisition of Senseonics, Incorporated in December 2015 (the “Acquisition”), (1) all outstanding shares of common stock of Senseonics, $ 0.01 par value per share, were exchanged for 1,955,929 shares of the Company's common stock, $ 0.001 par value per share (reflecting an exchange ratio of 2.0975 ), (2) all outstanding shares of preferred stock were converted into shares of common stock of Senseonics, and exchanged into 55,301,674 shares of the Company’s common stock, $ 0.001 par value per share, and (3) all outstanding options and warrants to purchase shares of common stock of Senseonics were exchanged for or replaced with options and warrants to acquire shares of the Company’s common stock using the same exchange ratio.
Common Stock
As of December 31, 2023 and December 31, 2022, the Company’s authorized capital stock included 900,000,000 shares of common stock, par value $ 0.001 per share. The Company had 530,364,237 and 479,637,138 shares of common stock issued and outstanding at December 31, 2023 and December 31, 2022, respectively.
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Preferred Stock
As of December 31, 2023 and 2022, the Company’s authorized capital stock included 5,000,000 shares of undesignated preferred stock, par value $ 0.001 per share. The Company had 12,000 shares of Series B Preferred Stock outstanding as of December 31, 2023 and 2022.
Voting Rights
The holders of Series B Preferred Stock generally are entitled to vote with the holders of the shares of common stock on all matters submitted for a vote of holders of shares of common stock (voting together with the holders of shares of common stock as one class) on an as-converted basis and shall be entitled to a number of votes per share equal to $ 1,000 divided by $ 1.24 , subject to a cap of 29.0 % of total voting power.
Dividends
The Series B Preferred Stock is not entitled to dividends.
Conversion Rights
Each share of Series B Preferred Stock is initially convertible into the number of shares of the common stock of the Company, $ 0.001 par value per share, equal to $ 1,000 divided by the conversion price of $ 0.3951 per share, subject to customary anti-dilution adjustments, including in the event of any stock split.
Stock Purchase Warrants
On June 30, 2016, the Company issued the Oxford/SVB Warrants to purchase an aggregate of 116,581 , 63,025 and 80,645 shares of common stock at an exercise price of $ 3.86 , $ 2.38 and $ 1.86 per share, respectively. The warrants were recorded within equity based on their fair value of $ 0.5 million. These warrants expire on June 30, 2026, November 22, 2026, and March 29, 2027, respectively, and are classified in equity.
On November 9, 2020, the Company issued the Energy Capital Warrants to purchase an aggregate of 10,000,000 shares of the Company’s common stock with an exercise price of $ 0.3951 per share. The Energy Capital Warrants are exercisable until November 9, 2030. The warrants were recorded within equity based on their fair value of $ 3.4 million. In February 2022, the Energy Capital Warrants were exercised in full, on a net basis and Energy Capital received 8,917,535 shares of common stock upon the net exercise of the warrants.
On March 13, 2023, the Company issued to PHC, the Purchase Warrant to purchase 15,425,750 shares of common stock. The Purchase Warrant is a “pre-funded” warrant with a nominal exercise price of $ 0.001 per Purchase Warrant Share. The Company received aggregate gross proceeds of $ 15.0 million, before deducting private placement expenses payable by the Company. The warrant was recorded in equity based on its fair value of $ 14.3 million. 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. All or any part of the Purchase Warrant is exercisable by the holder at any time and from time to time.
In addition, on March 13, 2023, the Company entered into an Exchange Agreement with PHC, and, on March 31, 2023, issued the PHC Exchange Warrant to purchase up to 68,525,311 shares of common stock in exchange for the cancellation in full of the PHC Notes, including accrued interest thereon. The PHC Exchange Warrant is a “pre-funded” warrant with a nominal exercise price of $ 0.001 per PHC Exchange Warrant Share. The warrant was recorded in equity based on its fair value of $ 48.6 million. All or any part of the Purchase Warrant is exercisable by the holder at any time and from time to time.
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On September 8, 2023, Company entered into the Loan and Security Agreement and issued the Tranche 1 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 Tranche 1 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 warrant agreement. The Tranche 1 Warrants were recorded in equity based on their fair value of $ 0.4 million . The number of shares for which the Tranche 1 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 warrant agreement.
15. Stock-Based Compensation
2015 Plan
In December 2015, the Company adopted the 2015 Equity Incentive Plan (the “2015 Plan”), under which incentive stock options and non-qualified stock options may be granted to the Company’s employees and certain other persons 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 expire ten 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 will automatically increase on January 1 of each year, beginning on January 1, 2017 and 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 December 31, 2023, 30,593,882 shares remained available for grant under the amended and restated 2015 Plan. Effective January 1, 2024, by virtue of the automatic increase described above, the total number of shares remaining available for grant under the amended and restated 2015 Plan was increased to 49,156,630 shares.
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 December 31, 2023, 233,825 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 December 31, 2023, 7,537,500 shares remained available for grant under the Commercial Equity Plan.
112
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 will automatically increase on January 1 of each year, beginning on January 1, 2017 and 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. At December 31, 2023 there were 17,624,582 shares of common stock available for issuance under the 2016 ESPP. Effective January 1, 2024, by virtue of the automatic increase described above, the total number of shares remaining available for issuance under the 2016 ESPP was increased to 22,928,224 shares.
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. The Company initiated its first 2016 ESPP offering period on August 1, 2019. On February 1, 2023, there were 86,816 shares purchased in connection with the offering period. On August 1, 2023, there were 135,496 shares purchased in connection with the offering period. 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 1,026,870 shares of the Company’s common stock underlying remain outstanding under the 1997 Plan. Upon the effectiveness of the 2015 Plan, the Company no longer grants any awards under the 1997 Plan.
Stock Options
The Company recognizes the cost of employee and non-employee services received in exchange for awards of equity instruments, such as stock options, based on the fair value of those awards at the date of grant. The estimated fair value of stock options on the date of grant is amortized on a straight-line basis over the requisite service period for each separately vesting portion of the award for those awards with service conditions only. For awards that also contain performance conditions, expense is recognized beginning at the time the performance condition is considered probable of being met over the remaining vesting period.
113
Stock option activity under the plans during the years ended December 31, 2023 and 2022 is as follows:
Weighted-
Weighted-
Average
Number of
Average
Remaining
Shares in
Exercise
Contractual
(in thousands)
Price
Life (in years)
Options outstanding as of December 31, 2021
13,384
$
2.38
5.71
Options granted
449
1.48
Options exercised
( 974 )
0.98
Options canceled/forfeited
( 1,080 )
2.52
Options outstanding as of December 31, 2022
11,779
2.45
5.07
Options granted
3,589
0.64
Options exercised
( 6 )
0.46
Options canceled/forfeited
( 1,622 )
1.22
Options outstanding as of December 31, 2023
13,740
$
2.12
5.18
Options vested and expected to vest as of December 31, 2023
13,740
$
2.12
Options exercisable as of December 31, 2023
10,638
$
2.52
3.97
The weighted average grant-date fair value of stock option awards granted in 2023 and 2022 was $ 0.47 and $ 1.04 per share, respectively.
For the years ended December 31, 2023 and 2022, 5,925 , and 974,285 , options were exercised, respectively, with an aggregate intrinsic value at the time of exercise of approximately $ 0.1 million and $ 1.0 million, respectively.
The total fair value of options that vested during 2023 and 2022 were approximately $ 0.5 million and $ 2.1 million, respectively.
The aggregate intrinsic value of the options currently exercisable at December 31, 2023 was $ 0.03 million. The aggregate intrinsic value of stock options outstanding at December 31, 2023 was $ 0.03 million, which approximated the aggregate intrinsic value of options vested and expected to vest as of December 31, 2023.
The weighted average grant date fair value of the unvested stock option awards outstanding at December 31, 2023 and 2022 was $ 0.54 and $ 1.29 per share, respectively. The weighted average grant date fair value of the stock option awards vested, exercised, and forfeited/cancelled for the year ended December 31, 2023 were $ 1.31 , $ 0.27 and $ 0.51 per share, respectively.
Fair value is estimated at each grant date under the plans using the Black-Scholes Model with assumptions summarized in the following table:
For the year ended December 31,
2023
2022
Expected term of options (in years)
6.0
-
6.5
6.5
Expected volatility rate
82.55
-
94.38
%
71.20
-
92.61
%
Risk-free interest rate
3.37
-
4.73
%
0.57
-
3.84
%
Expected dividend yield
0
%
0
%
The risk-free interest rate assumption is based upon observed U.S. treasury yields for a period consistent with the expected term of the Company’s employee and non-employee stock options. The expected term is the period of time for which the stock-based options are expected to be outstanding. The expected term is determined using the “simplified method” which is defined as the mid-point between the vesting date and the end of the contractual term. The Company does not pay a dividend, and is not expected to pay a dividend in the foreseeable future.
114
The Company utilizes comparable public companies’ volatility rates as a proxy of its expected volatility for purposes of the Black-Scholes Model. Stock-based compensation expense is recorded monthly and is adjusted periodically for actual forfeitures as they occur.
Stock-based compensation expense for employee and non-employee stock options was $ 0.7 million and $ 2.1 million, for the years ended December 31, 2023 and 2022, respectively, classified as follows (in thousands):
December 31,
2023
2022
Cost of sales
$
46
41
Research and development
322
712
Selling, general and administrative
290
1,381
Total stock-based compensation
$
658
$
2,133
As of December 31, 2023, there was $ 0.7 million of total unrecognized compensation cost related to non-vested stock option awards, which is expected to be recognized over a weighted average period of 2.13 years.
Restricted Stock Units
The Company issued 327,171 and 156,272 restricted stock units in lieu of cash payment for board and director fees to members of the Board of Directors during 2023 and 2022, respectively, under the non-employee director compensation policy. These restricted stock units were immediately vested upon issuance. In addition, the Company issued a total of 9,451,628 and 7,707,027 restricted stock units to employees of the Company during 2023 and 2022, respectively, as incentive compensation.
Restricted stock units granted annually to members of the Board of Directors vest on the earlier of the first anniversary of the grant date or the next year’s annual meeting of stockholders. New members of the Board of Directors may be granted initial restricted stock units which vest over a three-year period. Restricted stock units granted to employees in 2023 and 2022 vest in eight equal installments beginning with an initial accelerated vesting tranche in the month following the grant, followed by seven vesting dates every six months .
Restricted stock units activity under the Plans during the years ended December 31, 2023 and 2022, is as follows:
Weighted-
Weighted-
Average
Number of
Average
Remaining
Shares in
Exercise
Contractual
(in thousands)
Price
Life (in years)
RSU's outstanding as of December 31, 2021
12,756
$
0.82
2.44
Granted
7,863
1.17
Vested
( 9,414 )
0.77
Forfeited
( 1,426 )
1.08
RSU's outstanding as of December 31, 2022
9,779
1.10
2.19
Granted
13,633
0.74
Vested
( 9,309 )
0.89
Forfeited
( 234 )
0.97
RSU's outstanding as of December 31, 2023
13,869
$
0.89
2.29
For the year ended December 31, 2023, the weighted average grant date fair value of the restricted stock units granted, vested, and forfeited were $ 0.74 , $ 0.89 and $ 0.97 per share, respectively. The weighted average grant date fair value of total restricted stock units outstanding at December 31, 2023 was $ 0.89 per share.
115
For the year ended December 31, 2022, the weighted average grant date fair value of the restricted stock units granted, vested, and forfeited were $ 1.17 , $ 0.77 and $ 1.08 per share, respectively. The weighted average grant date fair value of restricted stock units outstanding at December 31, 2022 was $ 1.10 per share.
For the years ended December 31, 2023 and 2022, 9,309 , and 9,414 , restricted stock units were vested, respectively, with an aggregate intrinsic value at the time of vest of $ 6.4 million and $ 20.3 million, respectively.
The total fair value of the restricted stock units that vested during 2023 and 2022 were approximately $ 8.3 million and $ 7.3 million, respectively.
The aggregate intrinsic value of the restricted stock units currently outstanding at December 31, 2023 was $ 7.9 million.
Employee stock-based compensation expense for employee granted restricted stock units was $ 8.0 million and $ 6.5 million, for the years ended December 31, 2023 and 2022, respectively, classified as follows (in thousands):
December 31,
2023
2022
Cost of sales
$
63
31
Research and development
1,523
1,128
Selling, general and administrative
6,429
5,326
Total stock-based compensation
$
8,015
$
6,485
As of December 31, 2023, there was $ 11.1 million of total unrecognized compensation cost related to non-vested restricted stock units, which is expected to be recognized over a weighted average period of 2.29 years.
116
16.
Income Taxes
No provision for U.S. federal or state income taxes has been recorded as the Company has incurred net operating losses since inception and provides a full valuation allowance against its net deferred income tax assets. The tax effect of temporary differences that give rise to the net deferred income tax asset at December 31, 2023 and 2022 is as follows (in thousands):
December 31,
Deferred income tax assets (liabilities )
2023
2022
Deferred Tax Assets:
Net operating loss carryforwards
$
139,610
133,031
Capitalized start-up costs
5,721
6,538
Research and development credit carryforwards
15,326
13,121
Research and development expenditures
16,284
8,853
Stock-based compensation
1,684
1,695
Fair value of derivative liability
22
5,136
Other
3,181
2,143
Gross total deferred tax assets
181,828
170,517
Valuation allowance
( 179,517 )
( 163,255 )
Total net deferred tax assets
$
2,311
$
7,262
Deferred tax liabilities:
Right of use asset amortization
( 1,774 )
( 896 )
Amortization of debt discount
( 537 )
( 6,366 )
Total deferred tax liability
( 2,311 )
( 7,262 )
Net deferred tax assets
$
—
$
—
The net change in valuation allowance for the years ended December 31, 2023 and 2022 was a net increase of $ 16.3 million and a net increase of $ 16.8 million, respectively.
The increase in valuation allowance is primarily due to deferred tax assets generated from net operating losses, research and experimental costs capitalized, and tax credits generated in 2023 and is partially offset by a decrease in the deferred tax assets related to the fair value of derivative liability. This increase in valuation allowance is based on management's assessment that it is more likely than not that the Company will not realize these deferred tax assets. At December 31, 2023, the Company had NOL carryforwards of $ 656.9 million and research and experimental credit carryforwards of $ 15.3 million. Research and experimental credit carryforwards will expire in varying amounts between 2024 and 2043. NOL carryforwards in the amount of $ 196.4 million will expire in varying amounts between 2024 and 2037. NOL carryforwards incurred in tax years 2018 and forward have an indefinite carryforward period. Under the provisions of the Internal Revenue Code, certain substantial changes in the Company’s ownership may result in a limitation on the amount of NOL carryforwards and research and development credit carryforwards which can be available in future years.
117
A reconciliation of the Company’s estimated U.S. federal statutory rate to the Company’s effective income tax rate for years ended December 31, 2023 and 2022 is as follows:
Year Ended
December 31,
2023
2022
Tax at U.S. Federal Statutory rate
21.00
%
21.00
%
State taxes, net
0.25
0.40
Research and development credit
3.83
( 1.32 )
State tax rates changes
( 1.75 )
—
Convertible debt transactions
5.73
( 31.68 )
Equity based compensation
( 0.62 )
( 2.00 )
Officers compensation
( 0.99 )
1.68
Other
( 0.75 )
0.21
Increase (decrease) in valuation allowance
( 26.70 )
11.71
Effective income tax rate
0.00
%
0.00
%
Deferred income taxes reflect temporary differences in the recognition of revenue and expense for tax reporting and financial statement purposes. Deferred tax liabilities and assets are adjusted for changes in tax laws or tax rates of the various tax jurisdictions as of the enacted date. The federal tax rate remained unchanged at 21 % for the 2023 tax year. The change in state tax rate from 2022 to 2023 is primarily due to changes in applicable state apportionment factors and change in jurisdictions.
A breakdown of the Company’s uncertain tax position during 2023 and 2022 is as follows (in thousands):
2023
2022
Gross unrecognized tax benefit at beginning of year
$
3,280
2,813
Increase from tax positions taken in prior years
( 27 )
—
Increase from tax positions in current year
617
505
Lapse of statute of limitations / expiration
( 38 )
( 38 )
Gross unrecognized tax benefit at end of year
$
3,832
$
3,280
During 2022 and 2023, the Company incurred minor penalties and interest for filed tax returns due to taxing authorities.
If recognized, the entire amount of gross unrecognized tax benefit would favorably affect the effective income tax rate, although, due to the Company’s valuation allowance there would be no net impact. The Company does not expect a significant change in its unrecognized tax positions to occur in the next twelve months.
The Company’s U.S. Federal and state income tax returns from 2003 to 2023 remain subject to examination by the tax authorities. The Company’s prior tax years remain open for examination, even though the statute of limitations has expired, due to the net operating losses and credits carried forward for use in prospective years.
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 (see Note 13 for further discussion of the PHC Notes). Ascensia, through the ownership interests of its parent company, PHC is a related party. For the year ended December 31, 2023, revenue from Ascensia was $ 20.7 million and the amount due from Ascensia was $ 3.7 million. At December 31, 2023, the Company had estimated replacement obligations under warranties in the amount of $ 0.5 million and other amounts due to Ascensia of $ 0.5 million. We also purchase certain medical supplies from Ascensia for our clinical trials. We paid Ascensia $ 0.6 million for the year ended December 31, 2023 under this arrangement.
118
For the year ended December 31, 2022, revenue from Ascensia was $ 15.7 million and the amount due from Ascensia was $ 2.3 million. At December 31, 2022, the Company had estimated replacement obligations under warranties in the amount of $ 0.8 million and other amounts due to Ascensia of less than $ 0.1 million. We also purchase certain medical supplies from Ascensia for our clinical trials. We paid Ascensia $ 0.3 million for the year ended December 31, 2022 under this arrangement.
18. Fair Value Measurements
The Company applies fair value accounting for all financial assets and liabilities and non-financial assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis. The Company defines fair value as the price that would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. When determining the fair value measurements for assets and liabilities that are required to be recorded at fair value, the Company considers the principal or most advantageous market in which the Company would transact and the market-based risk measurements or assumptions that market participants would use to price the asset or liability, such as risks inherent in valuation techniques, transfer restrictions and credit risk. Fair value is estimated by applying the following hierarchy, which prioritizes the inputs used to measure fair value into three levels and bases the categorization within the hierarchy upon the lowest level of input that is available and significant to the fair value measurement:
Level 1 - Quoted prices in active markets for identical assets or liabilities.
Level 2 - Observable inputs other than quoted prices in active markets for identical assets and liabilities, quoted prices for identical or similar assets or liabilities in inactive markets, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
Level 3 - Inputs that are generally unobservable and typically reflect management’s estimate of assumptions that market participants would use in pricing the asset or liability.
Cash and Cash Equivalents
The fair value of money market funds and other investments classified as cash and cash equivalents are based on period-end statements supplied by the various banks and brokers that hold the majority of the funds.
Derivative Financial Instruments
The valuation technique used to measure the fair value of the Company’s embedded derivative instruments is valued using the binomial lattice model to estimate the fair value of the notes. Using this lattice model, the Company values the embedded derivative using the “with” and “without” approach to determine the fair value of the embedded derivatives associated with the convertible note. Under this approach, the instrument is valued “with” and “without” the bifurcated feature and the fair value of the derivative is the difference in value between the two scenarios. The lattice model incorporates assumptions such as management’s assumptions for probabilities of conversion occurrence through maturity, stock price, volatility, risk-free rate, estimated credit spread, bond recovery rates and trade data when available.
119
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 December 31, 2023 and 2022 (in thousands):
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
December 31, 2022
Total
Level 1
Level 2
Level 3
Assets
Money market funds⁽¹⁾
$
34,658
$
34,658
—
—
Commercial paper
41,503
—
41,503
—
Corporate debt securities
32,142
—
32,142
—
Asset backed securities
8,260
—
8,260
—
Government and agency securities
38,570
31,627
6,943
—
Liabilities
Embedded features of the 2023 Notes
$
20
—
20
—
Embedded features of the PHC Notes
44,191
—
—
44,191
Embedded features of the 2025 Notes
7,859
—
—
7,859
(1) Classified as cash and cash equivalents due to their short-term maturity
The following table provides a reconciliation of the beginning and ending balances of items measured at fair value on a recurring basis that used significant unobservable inputs (Level 3) (in thousands):
Year ended December 31
2023
2022
Beginning Balance
$
52,050
$
224,037
Conversion of financial instruments
( 1,109 )
( 25,656 )
Gain on fair value adjustment of option
—
( 43,745 )
Gain on change in fair value of derivatives
( 50,839 )
( 178,425 )
Loss on extinguishment of option
—
101
Financial asset impairment cost, net
—
138
Transfers into Level 3
—
81,417
Transfers out of Level 3
—
( 5,817 )
Ending balance
$
102
$
52,050
The recurring Level 3 fair value measurements of the embedded features of the 2025 Notes include the following significant unobservable inputs:
2025 Notes
Unobservable Inputs
Assumptions
Stock price volatility
45.0
%
Probabilities of conversion provisions
5.0 - 95.0
%
Credit spread
8.80
%
Significant changes to these assumptions would result in increases/decreases to the fair value of the liability.
120
The Company reviews the fair value hierarchy classification on a quarterly basis. Changes in the ability to observe valuation inputs may result in a reclassification of levels for certain financial instruments within the fair value hierarchy. The Company’s policy is to recognize transfers into and out of levels within the fair value hierarchy at the end of the fiscal quarter in which the actual event or change in circumstances that caused the transfer occurs. When a determination is made to classify an asset or liability within Level 3, the determination is based upon the significance of the unobservable inputs to the overall fair value measurement. During the year ended December 31, 2023, there were no transfers between Level 1, Level 2, or Level 3.
During the year ended December 31, 2022, transfers into Level 2 of liabilities previously classified in Level 3 were due to increased trade activity associated with these instruments providing better price transparency, permitting classification to Level 2. In addition, transfers into Level 3 of liabilities previously classified in Level 2 were an increase in unobservable inputs, permitting classification to Level 3.
19. Litigation
From time to time, the Company is subject to litigation and claims arising in the ordinary course of business. The Company accrues for litigation and claims when it is probable that a liability has been incurred and the amount of loss can be reasonably estimated. The Company has evaluated claims in accordance with the accounting guidance for contingencies that it deems both probable and reasonably estimable, and for the periods ended December 31, 2023 and 2022 has no such contingencies.
20. Subsequent Events
The Company has evaluated all subsequent events through the filing date of this Form 10-K with the SEC, to ensure that this filing includes appropriate disclosure of events both recognized in the financial statements as of December 31, 2023, 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.
As previously disclosed in Note 13, on Septembr 8, 2023 (“the Effective Date”), the Company entered into a Loan and Security Agreement with Hercules Capital, Inc. and the Lenders, pursuant to which the Lenders agreed to make available to the Company up to $ 50.0 million in senior secured term loans consisting of (i) an initial term loan of $ 25.0 million, 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. On January 2, 2024, the Tranche 2 Loan was funded in an amount of $ 10.0 million following the Company’s satisfaction of certain terms and conditions set forth in the Loan and Security Agreement in the fourth quarter of 2023. In connection with the Loan and Security Agreement, the Company issued additional warrants to the Lenders to acquire an aggregate of 347,887 shares at an exercise price of $ 0.5749 per share.
121
Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
None.