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
80
Report of Ernst & Young LLP , Auditor ID: 42 , Independent Registered Public Accounting Firm
82
Consolidated Balance Sheets as of December 31, 2022 and 2021
83
Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2022, 2021 and 2020
84
Consolidated Statements of Changes in Stockholders’ Deficit for the years ended December 31, 2022, 2021 and 2020
85
Consolidated Statements of Cash Flows for the years ended December 31, 2022, 2021 and 2020
86
Notes to Consolidated Financial Statements
87
79
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 sheet of Senseonics Holdings, Inc. and subsidiary (the Company) as of December 31, 2022, the related consolidated statement of operations and comprehensive loss, changes in stockholders’ deficit, and cash flows for the year then ended, 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, 2022, and the results of its operations and its cash flows for the year then ended, 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 audit. 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 audit 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 audit, 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 audit 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 audit 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 audit provides a reasonable basis for our opinion.
Critical Audit Matter
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of a critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Valuation of certain derivative liabilities
As discussed in Notes 3, 13, and 18 of the consolidated financial statements, the Company determined there are embedded derivative instruments within the Senior Secured Convertible Notes and the 2025 Senior Subordinated Notes (collectively, the Notes) that are bifurcated and accounted for separately as derivative financial instruments. The Company remeasures the fair value of the derivative liabilities of the Notes each reporting period, and the change in fair value of the derivative liabilities is recorded in other income and expense. The fair value measurement of the derivative liabilities of the Notes utilizes the binomial lattice model and includes assumptions and data that are based on
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unobservable inputs. As of December 31, 2022, the fair value of the derivative liabilities related to the Notes was $52.1 million.
We identified the valuation of the derivative liabilities of the Notes as a critical audit matter. A high degree of auditor judgment was required to evaluate the significant assumptions and data. The valuation methodology incorporates assumptions with significant measurement uncertainty, specifically the use of a credit spread from an observable transaction for a similar instrument and adjustments to the credit spread for subordination of the Notes. Further, the recovery rate data utilized in the subordination adjustment assumptions is a subjective input. The nature and extent of our procedures required the involvement of individuals with specialized skill and knowledge to assess the significant assumptions and data used.
The following are the primary procedures we performed to address this critical audit matter. We evaluated the design of the internal control over the valuation of the derivative liabilities of the Notes, specifically the control of the Company’s review of the significant assumptions and data. We involved valuation professionals with specialized skills and knowledge, who assisted in:
● evaluating the credit spread and subordination adjustment assumptions by comparing to existing market information from recent trade activity for a similar instrument
● comparing recovery rates used in the subordination adjustment calculations to independently sourced market data
● recalculating the subordination adjustments for mathematical accuracy
/s/ KPMG LLP
We have served as the Company’s auditor since 2022.
McLean, Virginia
March 15, 2023
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Report of Independent Registered Public Accounting Firm
To the Stockholders and the Board of Directors of Senseonics Holdings, Inc.:
Opinion on the Consolidated Financial Statements
We have audited the accompanying consolidated balance sheet of Senseonics Holdings, Inc. (the Company) as of December 31, 2021, the related consolidated statements of operations and comprehensive loss, changes in stockholders' equity (deficit), and cash flows for each of the two years in the period ended December 31, 2021, and the related notes, (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2021, and the results of its operations and its cash flows for each of the two years in the period ended December 31, 2021, in conformity with U.S. generally accepted accounting principles.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the 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 financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the 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 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 financial statements. We believe that our audits provide a reasonable basis for our opinion.
/s/ Ernst & Young LLP
We served as the Company’s auditor from 2015 to 2022.
Tysons, Virginia
March 1, 2022
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Senseonics Holdings, Inc.
Consolidated Balance Sheets
(in thousands, except for share and per share data)
December 31,
2022
2021
Assets
Current assets:
Cash and cash equivalents
$
35,793
$
33,461
Short term investments, net
108,222
96,445
Accounts receivable, net
127
205
Accounts receivable, net - related parties
2,324
1,768
Inventory, net
7,306
6,316
Prepaid expenses and other current assets
7,428
6,218
Total current assets
161,200
144,413
Option
—
239
Deposits and other assets
3,108
1,086
Long term investments, net
12,253
51,882
Property and equipment, net
1,112
1,308
Total assets
$
177,673
$
198,928
Liabilities and Stockholders’ Deficit
Current liabilities:
Accounts payable
$
419
$
1,204
Accrued expenses and other current liabilities
14,616
10,667
Accrued expenses and other current liabilities, related parties
837
3,597
Note payable, current portion, net
15,579
—
Derivative liability, current portion
20
—
Term Loans, net
—
2,926
Total current liabilities
31,471
18,394
Long-term debt and notes payables, net
56,383
59,798
Derivative liabilities
52,050
236,291
Option
—
69,401
Other liabilities
2,689
579
Total liabilities
142,593
384,463
Commitments and contingencies
Preferred stock and additional paid-in-capital, subject to possible redemption: $ 0.001 par value per share; 12,000 shares and 0 shares issued and outstanding as of December 31, 2022 and December 31, 2021
37,656
—
Total temporary equity
37,656
—
Stockholders’ deficit:
Common stock, $ 0.001 par value per share; 900,000,000 shares authorized as of December 31, 2022 and December 31, 2021; 479,637,138 shares and 447,282,263 shares issued and outstanding as of December 31, 2022 and December 31, 2021
480
447
Additional paid-in capital
806,488
765,215
Accumulated other comprehensive loss
( 678 )
( 212 )
Accumulated deficit
( 808,866 )
( 950,985 )
Total stockholders' deficit
( 2,576 )
( 185,535 )
Total liabilities, temporary equity and stockholders’ deficit
$
177,673
$
198,928
The accompanying notes are an integral part of these consolidated financial statements.
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Senseonics Holdings, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except for share and per share data)
Years Ended
December 31,
2022
2021
2020
Revenue, net
$
656
$
1,394
1,368
Revenue, net - related parties
15,733
12,281
3,581
Total revenue
16,389
13,675
4,949
Cost of sales
13,663
14,486
22,315
Gross profit (loss)
2,726
( 811 )
( 17,366 )
Expenses:
Research and development expenses
39,719
27,217
20,413
Selling, general and administrative expenses
31,634
29,154
41,351
Operating loss
( 68,627 )
( 57,182 )
( 79,130 )
Other income (expense), net:
Interest income
1,824
243
175
Gain (Loss) on fair value adjustment of option
43,745
( 53,152 )
( 30,721 )
Gain (Loss) on extinguishment of debt and option
( 101 )
330
( 21,112 )
Loss on issuance of debt & other issuance costs
—
—
( 12,706 )
Interest expense
( 18,703 )
( 16,720 )
( 16,167 )
Debt issuance costs
—
—
( 1,216 )
Gain (Loss) on change in fair value of derivatives
184,221
( 174,173 )
( 11,641 )
Impairment cost
( 138 )
( 1,647 )
( 2,339 )
Other expense
( 102 )
( 173 )
( 311 )
Total other income (expense), net
210,746
( 245,292 )
( 96,038 )
Net Income (loss)
142,119
( 302,474 )
( 175,168 )
Other comprehensive income (loss)
Unrealized gain (loss) on marketable securities
( 466 )
( 212 )
—
Total other comprehensive gain (loss)
( 466 )
( 212 )
—
Total comprehensive income (loss)
141,653
( 302,686 )
( 175,168 )
Basic net income (loss) per common share
0.30
( 0.72 )
( 0.77 )
Basic weighted-average shares outstanding
467,952,475
422,321,023
227,912,358
Diluted net income (loss) per common share
( 0.11 )
( 0.72 )
( 0.77 )
Diluted weighted-average shares outstanding
618,205,605
422,321,023
227,912,358
The accompanying notes are an integral part of these consolidated financial statements.
84
Senseonics Holdings, Inc.
Consolidated Statements of Changes in Stockholders’ (Deficit)
(in thousands)
Series A
Series B
Additional
Accumulated
Total
Convertible
Convertible
Common Stock
Paid-In
Other
Accumulated
Stockholders'
Preferred Stock
Preferred Stock
Shares
Amount
Capital
Comprehensive Loss
Deficit
Deficit
Temporary Equity
Temporary Equity
Balance, December 31, 2019
203,453
203
464,491
—
( 473,343 )
( 8,649 )
$
—
—
Issuance of convertible preferred stock, net of issuance costs
—
—
—
—
—
—
2,811
—
Issuance of common stock, net of issuance costs
329
—
( 26 )
—
—
( 26 )
—
—
Exercise of stock options and warrants
3,329
3
573
—
—
576
—
—
Exchange and conversion of convertible notes, net
58,470
60
27,199
—
—
27,259
—
—
Stock-based compensation expense and vesting of RSUs
—
—
7,314
—
—
7,314
—
—
Issuance of warrants related to debt
—
—
4,611
—
—
4,611
—
Net income
—
—
—
—
( 175,168 )
( 175,168 )
—
—
Balance, December 31, 2020
265,581
$
266
$
504,162
$
—
$
( 648,511 )
$
( 144,083 )
$
2,811
—
Issuance of convertible preferred stock, net of issuance costs
—
—
—
—
42,756
—
Conversion of preferred stock
54,166
54
45,511
—
—
45,565
( 45,567 )
—
Issuance of common stock, net of issuance costs
112,571
113
200,252
—
—
200,365
—
—
Exercise of stock options and warrants
5,732
5
4,988
—
—
4,993
—
—
Exchange and conversion of convertible notes, net
4,925
5
6,496
—
—
6,501
—
—
Issuance of common stock for vested RSUs and ESPP purchases
5,816
6
68
—
—
74
—
—
Shares withheld related to net share settlement of equity awards
( 1,509 )
( 2 )
( 5,291 )
( 5,293 )
Stock-based compensation expense
—
—
9,029
—
—
9,029
—
—
Net loss
—
—
—
—
( 302,474 )
( 302,474 )
—
—
Other comprehensive loss
—
—
—
( 212 )
—
( 212 )
—
—
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
The accompanying notes are an integral part of these consolidated financial statements.
85
Senseonics Holdings, Inc.
Consolidated Statements of Cash Flows
(in thousands)
Year Ended
December 31,
2022
2021
2020
Cash flows from operating activities
Net income (loss)
$
142,119
( 302,474 )
$
( 175,168 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and ROU amortization expense
985
1,239
1,141
Non-cash interest expense (debt discount and deferred costs)
12,164
8,462
10,977
Change in fair value of derivatives
( 184,221 )
174,173
11,641
(Gain) Loss on fair value adjustment of option
( 43,745 )
53,152
30,721
(Gain) Loss on extinguishment of option
101
( 330 )
21,112
Loss on issuance of debt & other issuance costs
—
—
12,706
Impairment of right-of-use asset
—
518
—
Impairment of option
138
1,647
2,339
Stock-based compensation expense
8,618
9,029
7,314
Loss on disposal of assets
—
10
181
Changes in assets and liabilities:
Accounts receivable
( 478 )
1,013
7,393
Prepaid expenses and other current assets
( 1,210 )
( 2,444 )
737
Inventory
( 989 )
( 1,036 )
11,648
Deposits and other assets
381
( 164 )
117
Accounts payable
( 785 )
( 559 )
( 2,522 )
Accrued expenses and other liabilities
1,462
2,218
( 6,585 )
Accrued interest
( 95 )
372
( 379 )
Operating lease liabilities
( 757 )
( 904 )
( 795 )
Net cash used in operating activities
( 66,312 )
( 56,078 )
( 67,422 )
Cash flows from investing activities
Capital expenditures
( 312 )
( 210 )
( 181 )
Purchase of marketable securities
( 104,706 )
( 154,514 )
—
Proceeds from sale and maturity of marketable securities
131,900
5,975
—
Net cash provided by (used in) investing activities
26,882
( 148,749 )
( 181 )
Cash flows from financing activities
Proceeds from issuance of common stock and warrants, net
34,174
200,365
( 26 )
Proceeds from exercise of stock options, RSU, ESPP & Warrants
1,084
5,066
576
Taxes paid related to net share settlement of equity awards
( 2,570 )
( 5,293 )
—
Proceeds from debt issuance, net
—
—
55,971
Note issuance costs
—
—
( 601 )
Proceeds from issuance of preferred stock, net
12,000
22,783
—
Repayment of term loans
( 2,926 )
( 2,838 )
( 66,050 )
Net cash provided by (used in) financing activities
41,762
220,083
( 10,130 )
Net increase (decrease) in cash and cash equivalents
2,332
15,256
( 77,733 )
Cash and cash equivalents, at beginning of period
33,461
18,205
95,938
Cash and cash equivalents, at ending of period
$
35,793
$
33,461
$
18,205
Supplemental disclosure of cash flow information
Cash paid during the period for interest
$
6,568
$
7,822
$
4,726
Lease liabilities arising from obtaining right-of-use assets
2,689
—
—
Supplemental disclosure of non-cash investing and financing activities
Property and equipment purchases included in accounts payable and accrued expenses
—
30
—
Conversion of options into redeemable convertible preferred stock
25,656
19,973
—
Issuance of common stock converted from preferred shares
—
54,166
—
Issuance of common stock converted from notes payables
—
4,925
227
Issuance of common stock and warrants - Highbridge transactions
—
—
55,303
Issuance of warrants - Energy Capital
—
—
3,399
Exchange of 2025 Notes for Second Lien Notes
—
—
( 24,000 )
Issuance of Second Lien Notes
—
—
15,675
The accompanying notes are an integral part of these consolidated financial statements.
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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 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 2022 and beyond. The Company generated total gross profit of $ 2.7 million for the twelve months ended December 31, 2022 and had an accumulated deficit of $ 808.9 million at December 31, 2022. 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, 2022, we had cash, cash equivalents and marketable securities of $ 156.3 million.
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 will receive a commission 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, 2022, the Company received $ 34.2 million in net proceeds from the sale of 15,160,899 shares of its common stock under the 2021 Sales Agreement.
In November 2019, the Company entered into an Open Market Sale Agreement (the “2019 Sales Agreement”) with Jefferies, under which the Company could offer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $ 50.0 million through Jefferies as the sales agent in an “at the market” offering. In June 2021, the Company received $ 48.4 million in net proceeds from the sale of 12,830,333 shares of its common stock utilizing the full capacity under the 2019 Sales Agreement.
On January 21, 2021, the Company entered into an underwriting agreement, which was subsequently amended and restated on the same day (the “Underwriting Agreement”) with H.C. Wainwright & Co., LLC, as representative of the underwriters (the “Underwriters”), to issue and sell 51,948,052 shares of common stock, in an underwritten public offering pursuant to effective registration statements on Form S-3, including and a related prospectus and prospectus supplement, in each case filed with the Securities and Exchange Commission (“the SEC”) (the “2021 Public Offering”). The price to the public in the 2021 Public Offering was $ 1.925 per share of common stock. The Underwriters agreed to
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purchase the shares from the Company pursuant to the Underwriting Agreement at a price of $ 1.799875 per share and the Company also agreed to reimburse them for customary fees and expenses. The initial closing of the 2021 Public Offering occurred on January 26, 2021. Subsequent to the initial closing, the Underwriters exercised their option to purchase an additional 7,792,207 shares of Common Stock. Total net proceeds from the 2021 Public Offering were $ 106.1 million after deducting underwriting discounts and commissions and estimated offering expenses.
On January 17, 2021, the Company entered into a Securities Purchase Agreement with certain institutional purchasers (the “Purchasers”), pursuant to which the Company sold to the Purchasers, in a registered direct offering (the “Registered Direct Offering”), an aggregate of 40,000,000 shares (the “Shares”) of common stock, $ 0.001 par value per share. The Shares were sold at a purchase price of $ 1.25 per share for aggregate gross proceeds to the Company of $ 50 million, before deducting fees to the placement agent and other estimated offering expenses payable by the Company. The Shares were offered and sold by the Company pursuant to an effective shelf registration statement on Form S-3, which was originally filed with the SEC on November 27, 2019. The net proceeds to the Company from the Registered Direct Offering, after deducting fees and expenses and the estimated offering expenses payable by the Company, were approximately $ 46.1 million.
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.
On August 9, 2020, the Company entered into a financing agreement with the parent company of Ascensia Diabetes Care Holdings AG (“Ascensia”), PHC Holdings Corporation (“PHC”), pursuant to which the Company issued $ 35.0 million in aggregate principal amount of Senior Secured Convertible Notes due on October 31, 2024 (the “PHC Notes”), to PHC. The Company also issued 2,941,176 shares of common stock to PHC as a financing fee. The Company also had the option to sell and issue PHC up to $ 15.0 million of convertible preferred stock on or before December 31, 2022, contingent upon obtaining U.S. Food and Drug Administration (“FDA”) approval for the 180-day Eversense product for marketing in the United States before such date. The Company successfully obtained FDA approval in February 2022 and the option was not exercised.
Additionally, on August 9, 2020, the Company entered into a Stock Purchase Agreement with Masters Special Solutions, LLC and certain affiliates thereof (collectively, “Masters”), pursuant to which the Company issued and sold to Masters 3,000 shares of convertible preferred stock, designated as Series A Preferred Stock (the “Series A Preferred Stock”), at a price of $ 1,000 per share in an initial closing. Masters also had the option to purchase up to an additional 27,000 shares of Series A Preferred Stock at a price of $ 1,000 per share in subsequent closings, subject to the terms and conditions of the Stock Purchase Agreement, as amended, through January 11, 2021. In January 2021, Masters and its
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assignees purchased in aggregate an additional 22,783 shares of Series A Preferred Stock, resulting in additional gross proceeds of $ 22.8 million. The excess of the purchase price and the fair value of the Masters option in the total amount of $ 42.8 million was recorded in additional-paid-in-capital. Each share of Series A Preferred Stock is initially convertible into a number of shares of common stock equal to $ 1,000 divided by the conversion price of $ 0.476 per share, subject to customary anti-dilution adjustments, including in the event of any stock split. All shares of Series A Preferred Stock have been converted to common stock as of December 31, 2021.
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 2024.
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 subsidiary Senseonics. 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, 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.
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,
2022
2021
Cash ⁽ ¹ ⁾
$
1,135
$
4,264
Money market funds
34,658
29,197
Cash and cash equivalents
$
35,793
$
33,461
(1) Includes overnight repurchase agreements.
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There was no restricted cash held as of December 31, 2022 and December 31, 2021.
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 no allowance for uncollectible accounts was recorded as of December 31, 2022 and December 31, 2021.
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.
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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 operating 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. Management identified indicators of impairment on right-of-use assets in 2021. There were no impairment indicators in 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.
When the equity or convertible debt instruments contain embedded derivative instruments that are to be bifurcated and accounted for as liabilities, the total proceeds received are first allocated to the fair value of all the bifurcated derivative instruments. The remaining proceeds, if any, are then allocated to the host instruments themselves, usually resulting in those instruments being recorded at a discount from their face value. The discount from the face value of the convertible debt, together with the stated interest on the instrument, is amortized over the term of the instrument as interest expense.
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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, 2022 and December 31, 2021, the warranty reserve was $ 0.8 million and $ 0.7 million, respectively. The following table provides a reconciliation of the change in estimated warranty liabilities for the years ended December 31, 2022 and 2021 (in thousands):
December 31,
December 31,
2022
2021
Balance at beginning of the period
$
723
$
646
Provision for warranties during the period
166
781
Settlements made during the period
( 108 )
( 704 )
Balance at end of the period
$
781
$
723
Revenue Recognition
We generate 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. The Company is paid for its 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.
Our contracts may contain some form of variable consideration such as prompt-pay discounts, tier-volume price discounts and for the Ascensia commercial 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 Ascensia Commercialization Agreement.
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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 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.
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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 2002 and all subsequent periods due to the availability of NOL 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, PHC Notes, 2023 Notes, 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
Recently Adopted
In August 2020, the FASB issued ASU 2020-06, Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contract in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”) . This new guidance is intended to reduce the complexity of accounting for convertible instruments. The guidance also addresses how convertible instruments are accounted for in the diluted earnings per share calculation and requires enhanced disclosures about the terms of convertible instruments. Entities may adopt ASU 2020-06 using either partial retrospective or fully retrospective method of transition. ASU 2020-06 is effective for public business entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. The Company adopted this guidance as of January 1, 2022 and its adoption did not have a material impact on the consolidated financial statements and related disclosures.
Not Yet Adopted
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
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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 plans to adopt the guidance effective January 1, 2023.
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, 2022, 2021 and 2020:
December 31, 2022
December 31, 2021
December 31, 2020
%
%
%
(Dollars in thousands)
Amount
of Total
Amount
of Total
Amount
of Total
Revenue, net:
Outside of the United States
$
8,877
54.2
%
$
11,117
81.3
%
$
3,821
77.2
%
United States
7,512
45.8
2,558
18.7
1,128
22.8
Total
$
16,389
100.0
%
$
13,675
100.0
%
$
4,949
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, 2022, and December 31, 2021 included unbilled accounts receivable of $ 1.7 million and $ 1.8 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 96 % of total net revenues for the year ended December 31, 2022. Ascensia accounted for 90 % of total net revenues for the year ended December 31, 2021.
Net revenue from distribution arrangement with Roche Diabetes Care GmbH, a related party, accounted for 72 % of total net revenues for the year ended December 31, 2020. Revenue from distribution arrangement with Edwards Healthcare Centers, Advanced Diabetes Supply, and Solara Medical Supply, strategic fulfillment partners and supplier of CGM systems to diabetic patients in the United States, accounted for 19 %, 15 %, and 10 %, respectively, of total net revenues for the year ended December 31, 2020.
5. Net Income (Loss) per Share
Basic net income (loss) per share attributable to common stockholders is calculated by dividing the net income
attributable to common stockholders by the weighted-average number of common shares outstanding during the period. Diluted 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
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and exercise of stock options and warrants are determined using the average share price for each period under the treasury stock method. Potentially dilutive common shares issuable upon conversion of the Company’s convertible notes are determined using the if converted method. The if-converted method assumes conversion of convertible securities at the beginning of the reporting period. Interest expense, dividends, and the changes in fair value measurement recognized during the period are added back to the numerator. The denominator includes the common shares issuable upon conversion of convertible securities.
In periods of net loss, all potentially dilutive common shares are excluded from the computation of the diluted net loss per share for those periods, as the effect would be anti-dilutive.
2022
2021
2020
Net income (loss)
142,119
( 302,474 )
( 175,168 )
Impact of conversion of dilutive securities
( 209,269 )
—
—
Dilutive Net income (loss)
( 67,150 )
( 302,474 )
( 175,168 )
Net income (loss) per share
Basic
0.30
( 0.72 )
( 0.77 )
Diluted
( 0.11 )
( 0.72 )
( 0.77 )
Basic weighted average shares outstanding
467,952,475
422,321,023
227,912,358
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
—
—
Energy Capital Option
30,372,058
—
—
Warrants
2,411,337
—
—
Diluted weighted average shares outstanding
618,205,605
422,321,023
227,912,358
Outstanding anti-dilutive securities not included in the diluted net income per share calculations were as follows:
2022
2021
2020
Stock-based awards
11,917,529
26,140,291
30,013,407
Masters preferred shares
—
—
6,302,521
2023 Notes
—
4,617,646
6,672,500
2025 Notes
—
39,689,142
44,728,676
PHC Notes
—
65,757,177
68,222,412
Warrants
427,821
13,177,822
17,282,792
Total anti-dilutive shares outstanding
12,345,350
149,382,078
173,222,308
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6.
Marketable Securities
Marketable securities available for sale, were as follows (in thousands):
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
December 31, 2021
Gross
Gross
Estimated
Amortized
Unrealized
Unrealized
Market
Cost
Gains
Losses
Value
Commercial Paper
$
57,369
—
—
$
57,369
Corporate debt securities
$
39,825
—
( 77 )
$
39,748
Asset backed securities
$
26,736
—
( 29 )
$
26,707
Government and agency securities
$
24,609
—
( 106 )
$
24,503
Total
$
148,539
$
—
$
( 212 )
$
148,327
The following are the scheduled maturities as of December 31, 2022 (in thousands):
Net
Fair
Carrying Amount
Value
2023
$
108,797
$
108,222
2024
5,620
5,608
2025
6,736
6,645
Total
$
121,153
$
120,475
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, 2022 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.
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7.
Inventory, net
Inventory, net consisted of the following (in thousands):
December 31,
2022
2021
Finished goods
$
1,697
$
1,012
Work-in-process
4,057
3,770
Raw materials
1,552
1,534
Total
$
7,306
$
6,316
The Company recorded $ 1.4 million, $ 2.4 million and $ 15.1 million in cost of sales for the years ended December 31, 2022, 2021 and 2020, 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, 2022 and 2021 (in thousands):
December 31,
2022
2021
Contract manufacturing⁽¹⁾
$
4,097
$
5,036
Insurance
1,243
74
Clinical and Preclinical
924
142
Interest receivable
336
443
Accounting and Audit
270
—
IT and software
189
225
Sales and Marketing
158
98
Rent and utilities
132
105
Research and development
67
39
Other
12
56
Total prepaid expenses and other current assets
$
7,428
$
6,218
(1)
Includes deposits to contract manufacturers for manufacturing process.
9. Property and Equipment, net
Property and equipment, net consisted of the following as of December 31, 2022 and 2021 (in thousands):
December 31,
2022
2021
Machinery and laboratory equipment
$
2,668
$
2,357
Office furniture and equipment
354
354
Leasehold improvements
128
127
3,150
2,838
Less: Accumulated depreciation
( 2,038 )
( 1,530 )
Property and equipment, net
$
1,112
$
1,308
Depreciation expense for the years ended December 31, 2022, 2021, and 2020 was $ 0.5 million, $ 0.5 million, and $ 0.4 million, respectively. There was no property and equipment disposed during 2022. The Company disposed of $ 0.1 million and $ 0.3 million of property and equipment in 2021 and 2020 respectively.
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10.
Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following as of December 31, 2022 and 2021 (in thousands):
December 31,
2022
2021
Compensation and benefits
$
4,699
$
3,484
Research and development
3,502
2,145
Contract manufacturing
2,480
914
Interest on notes payable
2,050
2,144
Professional and administration services
1,053
1,011
Product warranty and replacement obligations
781
1,697
Operating lease
725
904
Sales and marketing services
149
1,962
Other
14
3
Total accrued expenses and other current liabilities
$
15,453
$
14,264
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 expiring in 2028. In June 2022, the Company extended our lease for an additional five-year term through 2028. The lease does not include additional extension options. We recorded a modification to our right-of-use asset and lease liability for the additional lease term, resulting in a remeasurement of the existing right-of-use asset and lease liability.
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 the option to renew the lease for an additional term. 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 the Company will continue making lease payments until the lease expires. An impairment charge of $ 0.5 million was recorded during the twelve months ended December 31, 2021.
Operating lease expense for the year ended December 31, 2022, 2021 and 2020 was $ 0.7 million, 0.9 million, and $ 0.9 million, respectively.
The following table summarizes the lease assets and liabilities as of December 31, 2022 and 2021 (in thousands):
December 31,
Operating Lease Assets and Liabilities
Balance Sheet Classification
2022
2021
Assets
Operating lease ROU assets
Deposits and other assets
$
3,032
821
Liabilities
Current operating lease liabilities
Accrued expenses and other current liabilities
$
725
904
Non-current operating lease liabilities
Other non-current liabilities
2,689
579
Total operating lease liabilities
$
3,414
1,483
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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, 2022 (in thousands):
2023
1,006
2024
709
2025
730
2026
752
2027
774
2028
327
Total
4,298
Present value adjustment
( 884 )
Present value of lease liabilities
$
3,414
The following table summarizes the weighted-average lease term and weighted-average discount rate as of December 31, 2022 and 2021:
Remaining lease term (years)
2022
2021
Operating leases
5.0
1.6
Discount rate
Operating leases
9.1
%
9.1
%
During the year ended December 31, 2022, the Company made cash payments of $ 1.0 million included in the measurement of its operating lease liabilities.
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, 2022, 2021, and 2020 were $ 0.4 million, $ 0.3 million, and $ 0.1 million, respectively. Administrative expenses for the plan, which are paid by the Company, were not material in 2022, 2021 or 2020.
13.
Notes Payable, Preferred Stock and Stock Purchase Warrants
Term Loans
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.
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Convertible Preferred Stock and Warrants
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 is 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, including 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 has 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 provides 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, subject to the satisfaction of certain conditions, if the full $ 12.0 million of Series B Preferred Stock has not been sold pursuant to Regular Purchases, Energy Capital may, at its sole discretion, by its delivery to the Company of a Purchase Notice, from time to time, purchase up to the amount then remaining available 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,
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.
On August 9, 2020, the Company entered into a Stock Purchase Agreement with Masters, pursuant to which the Company issued and sold to Masters 3,000 shares of Series A Preferred Stock, at a price of $ 1,000 per share in an initial closing. Masters also had the option to purchase up to an additional 27,000 shares of Series A Preferred Stock at a price of $ 1,000 per share in a subsequent closing, subject to the terms and conditions of the Stock Purchase Agreement, as amended, through January 11, 2021. In January 2021, Masters and its assignees purchased in aggregate an additional 22,783 shares of Series A Preferred Stock, resulting in additional gross proceeds to the Company of $ 22.8 million. Each share of Series A Preferred Stock was initially convertible into a number of shares of common stock equal to $ 1,000 divided by the conversion price of $ 0.476 per share, subject to customary anti-dilution adjustments, including in the event of any stock split. All shares of Series A Preferred Stock have been converted to common stock as of December 31, 2021. Masters’ option to purchase the remaining unissued shares of Series A Preferred Stock expired on January 11, 2021, resulting in a gain on extinguishment of $ 3.5 million.
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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 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 are senior secured obligations of the Company and will be guaranteed on a senior secured basis by the Company’s wholly owned subsidiary, Senseonics, Incorporated. Interest at the annual rate of 9.5 % is payable semi-annually in cash or, at the Company’s option, payment in kind. The interest rate decreased to 8.0 % in April 2022 as a result of the Company having obtained FDA approval for the 180-day 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 are 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) is 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 will, in certain circumstances, 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 will be required to pay cash in lieu of delivering make whole shares unless the Company obtains stockholder approval to issue such shares.
Subject to specified conditions, on or after October 31, 2022, the PHC Notes are redeemable by the Company if the closing sale price of the common stock exceeds 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 are 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 contains 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 are subject to certain minimum thresholds and exceptions. The Note Purchase Agreement also contains 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 has 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
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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 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. The fair value of the derivative as of December 31, 2022 was $ 44.2 million.
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.
The PHC 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. The fair value of the Company’s PHC Notes, excluding the embedded features, was $ 32.2 million as of December 31, 2022 and $ 15.3 million as of December 31, 2021.
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.
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
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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. The fair value of the Company’s 2025 Notes, excluding the embedded features, was $ 41.3 million as of December 31, 2022 and $ 30.3 million at December 31, 2021.
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.
For the twelve months ended December 31, 2022, there were no conversions of outstanding principal for shares of common stock.
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 are 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 2023 Notes are general, unsecured, senior subordinated obligations of the Company. The Company pays 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. As the 2023 Notes have a maturity date of February 1, 2023, they are classified as a short-term liability on the Company’s consolidated balance sheet at December 31, 2022.
Each $ 1,000 of principal of the 2023 Notes is initially convertible into 294.1176 shares of the Company’s common stock, which is equivalent to an initial conversion price of approximately $ 3.40 per share, subject to adjustment upon the occurrence of specified events. Holders may convert at any time prior to February 1, 2023. Holders who convert on or after the date that is six months after the last date of original issuance of the 2023 Notes but prior to
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February 1, 2021, may also be entitled to receive, under certain circumstances, an interest make-whole payment payable in shares of common stock. If specific corporate events occur prior to the maturity date, the Company will increase the conversion rate pursuant to the make-whole fundamental change provision for a holder who elects to convert their 2023 Notes in connection with such an event in certain circumstances. Additionally, if a fundamental change occurs prior to the maturity date, holders of the 2023 Notes may require the Company to repurchase all or a portion of their 2023 Notes for cash at a repurchase price equal to 100 % of the principal amount plus any accrued and unpaid interest.
The Company bifurcated the embedded conversion option, along with the interest make-whole provision and make-whole fundamental change provision, and in January 2018 recorded the embedded features as a debt discount and derivative liability in the Company’s consolidated balance sheets at its initial fair value of $ 17.3 million. Additionally, the Company incurred transaction costs of $ 2.2 million. The debt discount and transaction costs are being amortized to interest expense over the term of the 2023 Notes at an effective interest rate of 9.30 %. The derivative is adjusted to fair value at each reporting period, with the change in the fair value recorded to other income (expense) in the Company’s consolidated statement of operations and comprehensive loss.
The fair value of the Company’s 2023 Notes, excluding the embedded features, was $ 15.5 million as of December 31, 2022 and $ 14.2 million at December 31, 2021. There were no conversions of 2023 Notes in the years ended December 31, 2022 or 2021.
The following carrying amounts are outstanding under the Company’s notes payable as of December 31, 2022 and December 31, 2021 (in thousands):
December 31, 2022
Principal ($)
Debt Discount ($)
Issuance Costs ($)
Carrying Amount ($)
2023 Notes
15,700
( 121 )
-
15,579
2025 Notes
51,199
( 15,029 )
( 252 )
35,918
PHC Notes
35,000
( 13,698 )
( 837 )
20,465
December 31, 2021
Principal ($)
Debt Discount ($)
Issuance Costs ($)
Carrying Amount ($)
2023 Notes
15,700
( 1,499 )
-
14,201
2025 Notes
51,199
( 20,535 )
( 344 )
30,320
PHC Notes
35,000
( 18,587 )
( 1,136 )
15,277
PPP Loan
2,926
-
-
2,926
Interest expense related to the notes payable for the periods presented below is as follows (in thousands):
Year Ended December 31, 2022
Interest Rate
Interest ($)
Debt Discount and Fees ($)
Issuance Costs ($)
Loss on Extinguishment ($)
Total Interest Expense ($)
2023 Notes
5.25 %
824
1,378
-
-
2,202
2025 Notes
5.25 %
2,674
5,506
92
-
8,272
PHC Notes
8.00 %
3,035
4,889
299
-
8,223
PPP Loan
1.00 %
6
-
-
-
6
Total
6,539
11,773
391
-
18,703
Year Ended December 31, 2021
Interest Rate
Interest ($)
Debt Discount and Fees ($)
Issuance Costs ($)
Loss on Extinguishment ($)
Total Interest Expense ($)
2023 Notes
5.25 %
824
1,256
-
-
2,080
2025 Notes
5.25 %
2,717
4,569
76
3,183
10,545
PHC Notes
9.50 %
3,287
3,650
223
-
7,160
PPP Loan
1.00 %
54
-
-
-
54
Total
6,882
9,475
299
3,183
19,839
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The following are the scheduled maturities of the outstanding debt, including the 2025 Notes, PHC Notes, and 2023 Notes as of December 31, 2022:
2023
$
15,700
2024
35,000
2025
51,199
Total
$
101,899
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, 2022 and December 31, 2021, the Company’s authorized capital stock included 900,000,000 shares of common stock, par value $ 0.001 per share. The Company had 479,637,138 and 447,282,263 shares of common stock issued and outstanding at December 31, 2022 and December 31, 2021, respectively.
Preferred Stock
As of December 31, 2022 and 2021, 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, 2022 and 0 shares of preferred stock outstanding as of December 31, 2021.
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.
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On July 16, 2019, the Company issued the Solar Warrants to purchase an aggregate of 1,125,000 shares of the Company’s common stock with an exercise price of $ 1.20 per share. The Solar Warrants are exercisable until July 25, 2029. The warrants were recorded within equity based on their fair value of $ 0.7 million. In February 2021, the Solar Warrants were exercised in full, on a net basis and the lenders received 868,833 shares of common stock upon the net exercise of the warrants.
On April 24, 2020, the Company issued the Highbridge Warrants to purchase an aggregate of 4,500,000 shares of the Company’s common stock with an exercise price of $ 0.66 per share. The Highbridge Warrants are exercisable until April 24, 2023. The warrants were recorded within equity based on their fair value of $ 1.3 million. During the year ended December 31, 2021, the warrant holders exercised 1,750,000 warrants and the Company received $ 1.16 million in cash proceeds for the exercise. There were no warrants exercised for the year ended December 31, 2022.
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.
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, 2022, 22,366,134 shares remained available for grant under the amended and restated 2015 Plan. Effective January 1, 2023, 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 39,153,434 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, 2022, 684,473 shares remained available for grant under the Inducement Plan.
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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, 2022 there were 13,050,523 shares of common stock available for issuance under the 2016 ESPP. Effective January 1, 2023, by virtue of the automatic increase described above, the total number of shares remaining available for issuance under the 2016 ESPP was increased to 17,846,894 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, 2022, there were 28,944 shares purchased in connection with the offering period. On August 1, 2022, there were 64,109 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 1,223,273 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 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.
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Stock option activity under the Plans during the years ended December 31, 2022, 2021 and 2020 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, 2020
15,775
$
2.16
Granted
224
$
2.98
Exercised
( 2,355 )
$
1.61
Cancelled/forfeited
( 260 )
$
3.06
Options outstanding as of December 31, 2021
13,384
5.71
Granted
449
$
1.48
Exercised
( 974 )
$
0.98
Cancelled/forfeited
( 1,080 )
$
2.52
Options outstanding as of December 31, 2022
11,779
5.07
Options vested and exercisable as of December 31, 2022
11,138
$
2.48
4.87
The weighted average grant-date fair value of stock option awards granted in 2022, 2021 and 2020 was $ 1.04 , $ 1.97 , and $ 0.33 per share, respectively.
For the years ended December 31, 2022, 2021 and 2020, 974,285 , 2,354,566 , and 201,447 , options were exercised, respectively, with an aggregate intrinsic value at the time of exercise of $ 1.0 million, $ 4.4 million, and $ 0.1 million, respectively.
The total fair value of options that vested during 2022 and 2021 were approximately $ 2.1 million and $ 3.1 million, respectively.
The aggregate intrinsic value of the options currently exercisable at December 31, 2022 was $ 0.4 million. The aggregate intrinsic value of stock options outstanding at December 31, 2022 was $ 0.4 million, which approximated the aggregate intrinsic value of options vested and expected to vest as of December 31, 2022.
The weighted average grant date fair value of the unvested stock option awards outstanding at December 31, 2022 and 2021 was $ 1.29 and $ 1.58 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, 2022 were $ 1.63 , $ 0.59 and $ 1.06 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,
2022
2021
2020
Expected term of options (in years)
6.5
6.5
6.5
Expected volatility rate
71.20
-
92.61
%
69.93
-
73.32
%
66.50
-
67.41
%
Risk-free interest rate
0.57
-
3.84
%
0.59
-
1.25
%
0.41
-
1.80
%
Expected dividend yield
0
%
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 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.
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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.
Employee stock-based compensation expense for employee granted stock options was $ 2.1 million, $ 3.2 million and $ 5.2 million, for the years ended December 31, 2022 and 2021 and 2020, respectively, classified as follows (in thousands):
December 31,
2022
2021
2020
Cost of sales
$
41
30
59
Sales and marketing
302
545
1,570
Research and development
712
1,112
1,189
General and administrative
1,078
1,517
2,349
Total stock-based compensation
$
2,133
$
3,204
$
5,167
As of December 31, 2022, there was $ 0.7 million of total unrecognized compensation cost related to non-vested employee stock option awards, which is expected to be recognized over a weighted average period of 2.28 years.
Restricted Stock Units
The Company issued 156,272 and 117,290 restricted stock units in lieu of cash payment for board and director fees to members of the Board of Directors during 2022 and 2021, respectively. These restricted stock units were immediately vested upon issuance. The Company also issued 7,707,027 and 4,603,440 restricted stock units to members of the Board of Directors as equity compensation under the Company’s non-employee director compensation policy and to employees of the Company during 2022 and 2021, respectively, as incentive compensation.
Restricted stock units granted annually to members of the Board of Directors vest one year after the grant date. New members of the Board of Directors are granted initial restricted stock units which vest monthly over a three-year period. There were no new members of the Board of Directors during 2022. Restricted stock units granted to employees in 2022 and 2021 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, 2022, 2021 and 2020 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, 2020
14,238
$
0.45
Granted
4,603
1.80
Vested
( 5,816 )
0.71
Forfeited
( 270 )
0.56
RSU's outstanding as of December 31, 2021
12,756
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
2.19
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 total restricted stock units outstanding at December 31, 2022 was $ 1.10 per share.
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For the year ended December 31, 2021, the weighted average grant date fair value of the restricted stock units granted, vested, and forfeited were $ 1.80 , $ 0.71 and $ 0.56 per share, respectively. The weighted average grant date fair value of restricted stock units outstanding at December 31, 2021 was $ 0.80 per share.
For the years ended December 31, 2022 and 2021, 9,414 , and 5,816 , restricted stock units were vested, respectively, with an aggregate intrinsic value at the time of vest of $ 20.3 million and $ 15.9 million, respectively.
The total fair value of the restricted stock units that vested during 2022 and 2021 were approximately $ 7.3 million and $ 4.1 million, respectively.
The aggregate intrinsic value of the restricted stock units currently outstanding at December 31, 2022 was $ 10.1 million.
Employee stock-based compensation expense for employee granted restricted stock units was $ 6.5 million, $ 5.8 million and $ 2.1 million, for the years ended December 31, 2022 and 2021 and 2020, respectively, classified as follows (in thousands):
December 31,
2022
2021
2020
Cost of sales
$
31
14
8
Sales and marketing
454
548
338
Research and development
1,128
1,483
290
General and administrative
4,872
3,780
1,452
Total stock-based compensation
$
6,485
$
5,825
$
2,088
As of December 31, 2022, there was $ 9.4 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 2.19 years.
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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, 2022 and 2021 is as follows (in thousands):
December 31,
Deferred income tax assets (liabilities )
2022
2021
Deferred Tax Assets:
Net operating loss carryforwards
$
133,031
125,242
Capitalized start-up costs
6,538
7,315
Research and development credit carryforwards
13,121
11,251
Research and development expenditures
8,853
—
Stock-based compensation
1,695
2,061
Fair value of derivative liability
5,136
8,853
Other
2,143
912
Gross total deferred tax asset
170,517
155,634
Valuation allowance
( 163,255 )
( 146,463 )
Total net deferred tax assets
$
7,262
$
9,171
Deferred tax liabilities:
Right of use amortization
( 896 )
( 318 )
Amortization of debt discount
( 6,366 )
( 8,853 )
Total deferred tax liability
( 7,262 )
( 9,171 )
Net deferred tax assets
$
—
$
—
The net change in valuation allowance for the years ended December 31, 2022 and 2021 was a net increase of $ 16.8 million and a net increase of $ 10.4 million, respectively.
The increase in valuation allowance is primarily due to deferred tax assets generated from net operating losses incurred in 2022. 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, 2022, the Company had NOL carryforwards of $ 621.5 million and research and experimental credit carryforwards of $ 13.1 million. Research and experimental credit carryforwards will expire in varying amounts between 2023 and 2042. NOL carryforwards in the amount of $ 197.5 million will expire in varying amounts between 2023 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.
112
A reconciliation of the Company’s estimated U.S. federal statutory rate to the Company’s effective income tax rate for the years ended December 31, 2022, 2021 and 2020 is as follows:
Year Ended
December 31,
2022
2021
2020
Tax at U.S. Federal Statutory rate
21.00
%
21.00
%
21.00
%
State taxes, net
0.40
1.60
2.32
Research and development credit
( 1.32 )
0.34
0.46
State tax rates changes
—
( 2.18 )
( 0.85 )
Convertible debt transactions
( 31.68 )
( 17.09 )
( 11.15 )
Equity based compensation
( 2.00 )
1.01
—
Officers compensation
1.68
( 0.96 )
—
Other non-deductible items
0.21
( 0.50 )
( 0.44 )
Increase (decrease) in valuation allowance
11.71
( 3.22 )
( 11.34 )
Effective income tax rate
0.00
%
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 2022 tax year. The change in state tax rate from 2020 to 2021 and from 2021 to 2022 is primarily due to changes in applicable state apportionment factors and change in jurisdictions.
A breakdown of the Company’s uncertain tax position during 2022, 2021 and 2020 is as follows (in thousands):
2022
2021
2020
Gross unrecognized tax benefit at beginning of year
$
2,813
2,552
2,351
Increase from tax positions taken in prior years
—
—
—
Increase from tax positions in current year
505
267
201
Lapse of statute of limitations / expiration
( 38 )
( 6 )
—
Gross unrecognized tax benefit at end of year
$
3,280
$
2,813
$
2,552
In 2022 and 2021, the Company incurred minor penalties for filed tax returns. The Company did not incur any penalties or interest payable to taxing authorities in 2020.
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 2002 to 2022 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, 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.
For the year ended December 31, 2021, revenue from Ascensia was $ 12.3 million and the amount due from Ascensia was $ 1.8 million. At December 31, 2021, the Company had estimated replacement obligations under warranties
113
in the amount of $ 0.7 million and marketing campaign support obligations in the amount of $ 1.8 million. For the year ended December 31, 2020, revenues from Ascensia and amounts due to and from them were immaterial.
Roche Holding AG, through its ownership interests in Roche Finance Ltd, has a noncontrolling ownership interest in the Company. There were no revenues or amounts due from Roche for the year ended December 31, 2022. For the year ended December 31, 2021 revenues from Roche were less than $ 0.1 million, and there were no amounts due from them. For the year ended December 31, 2020, revenues from Roche were $ 3.6 million and amounts due from them were $ 2.4 million.
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.
114
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, 2022 and 2021 (in thousands):
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
December 31, 2021
Total
Level 1
Level 2
Level 3
Assets
Money market funds⁽¹⁾
$
29,197
$
29,197
—
—
Commercial paper
57,369
—
57,369
—
Corporate debt securities
39,748
—
39,748
—
Asset backed securities
26,707
—
26,707
—
Government and agency securities
24,503
19,957
4,546
—
PHC Option
239
—
—
239
Liabilities
Energy Capital Option
$
69,401
$
—
—
69,401
Embedded features of the 2023 Notes
5,817
—
—
5,817
Embedded features of the PHC Notes
149,058
—
—
149,058
Embedded features of the 2025 Notes
81,417
—
81,417
—
(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
2022
2021
Beginning Balance
$
224,037
$
84,117
Conversion of financial instruments
( 25,656 )
( 19,973 )
(Gain) Loss on fair value adjustment of option
( 43,745 )
53,152
(Gain) Loss on change in fair value of derivatives
( 178,425 )
108,606
(Gain) Loss on extinguishment of option
101
( 3,513 )
Financial asset impairment cost, net
138
1,648
Transfers into Level 3
81,417
—
Transfers out of Level 3
( 5,817 )
—
Ending balance
$
52,050
$
224,037
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The recurring Level 3 fair value measurements of the embedded features of the PHC Notes and 2025 Notes include the following significant unobservable inputs:
PHC Notes
2025 Notes
Unobservable Inputs
Assumptions
Assumptions
Stock price volatility
99.0
%
110.0
%
Probabilities of conversion provisions
5.0 - 10.0
%
5.0 - 10.0
%
Credit spread
13.96
%
13.96
%
Recovery rate
- 5.51
%
- 1.56
%
Dividend yield
—
%
—
%
Significant changes to these assumptions would result in increases/decreases to the fair value of the liability.
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. 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. There were no transfers between Level 1 , Level 2 , or Level 3 during the year ended December 31, 202 1. 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.
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 period ended December 31, 2022 and 2021 has no such contingencies.
20. Reclassification of Prior Year Presentation
Certain prior year amounts have been reclassified for consistency with the current year presentation. These reclassifications had no effect on the reported results of operations or previously reported cash flows from operating activities.
An adjustment has been made to the Consolidated Statements of Operations and Comprehensive Income (Loss) for the twelve months ended December 31, 2021 and December 31, 2020 to consolidate the separate line items Sales and marketing expenses and General and administrative expenses to the single line item Selling, general and administrative expenses. In addition, an adjustment has been made to the Consolidated Statements of Cash Flows for the twelve months ended December 31, 2020 to reclass the provision for inventory obsolescence and net realizable value of ($ 4.2 ) million to change in Inventory.
21. 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, 2022, 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.
116
On January 30, 2023, the Company authorized 10,000,000 shares of common stock pursuant to the Senseonics Holdings, Inc. 2023 Commercial Equity Plan to provide the ability to grant equity incentive awards to employees of our global commercial partner, Ascensia.
On January 31, 2023, the Company fully repaid the 2023 Notes, in the principal amount of $ 15.7 million and $ 0.4 million of accrued interest.
On March 13, 2023, the Company entered into an Exchange Agreement (the “Exchange Agreement”) with PHC, pursuant to which PHC has agreed to exchange (the “Exchange”) the PHC Notes, including all accrued and unpaid interest thereon, for a warrant (the “Exchange Warrant”) to purchase up to 68,525,311 shares of common stock (the “Exchange Warrant Shares”). The Exchange Warrant is a “pre-funded” warrant with a nominal exercise price of $ 0.001 per Exchange Warrant Share. The Exchange is expected to close on or about April 1, 2023, subject to customary closing conditions for a transaction of this type.
On March 13, 2023, the Company issued and sold to PHC in a private placement (the “Private Placement”) a warrant (the “Purchase Warrant”) to purchase an aggregate of 15,425,750 shares of common stock (the “Purchase Warrant Shares”) and the Company received aggregate gross proceeds of $ 15.0 million. The Purchase Warrant is a “pre-funded” warrant with a nominal exercise price of $ 0.001 per Purchase Warrant Share.
The Company has a banking relationship with Silicon Valley Bridge Bank (formerly Silicon Valley Bank, or SVB). On March 10, 2023, less than one percent of the Company’s total cash and cash equivalents were held by SVB. On March 13, 2023, all operating accounts and funds held by SVB were made available to the Company. The Company has diversified its banking relationships and will continue to review its treasury operations. Based on the foregoing and the Company’s analysis of the components of its relationship with SVB, the Company does not expect recent events concerning SVB to have a material impact on the Company’s consolidated financial statements.
117
Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
None.