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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported):
February 29, 2024
SENSEONICS
HOLDINGS, INC. |
(Exact Name of Registrant as Specified in its Charter) |
Delaware |
|
001-37717 |
|
47-1210911 |
(State or Other
Jurisdiction of Incorporation) |
|
(Commission File Number) |
|
(IRS Employer
Identification No.) |
20451 Seneca Meadows Parkway
Germantown, MD 20876-7005 |
(Address of Principal Executive Office) (Zip Code) |
Registrant's telephone number, including
area code: (301) 515-7260
Not Applicable
Former name or former address, if changed
since last report
Check the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions
(see General Instruction A.2 below):
| ¨ | Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Common Stock |
SENS |
NYSE American |
Indicate by check mark whether the registrant is an emerging
growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ¨
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 2.02. Results of Operations and Financial Condition.
On February 29, 2024, Senseonics Holdings, Inc.
(the “Company”) issued a press release announcing its financial results for the quarter and year ended December 31, 2023,
as well as information regarding a conference call to discuss these financial results and the Company’s recent corporate highlights
and outlook. This press release has been furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein
by this reference.
The information in this Current Report on Form 8-K,
including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18
of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section.
The information contained herein and in the accompanying exhibit is not incorporated by reference in any filing of the Company under the
Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof and irrespective of any general
incorporation language in any filings.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: February 29, 2024 |
SENSEONICS HOLDINGS, INC. |
|
|
|
By: |
/s/ Rick Sullivan |
|
Name: |
Rick Sullivan |
|
Title: |
Chief Financial Officer |
Exhibit 99.1
SENSEONICS HOLDINGS, INC. REPORTS FOURTH QUARTER AND FULL YEAR
2023 FINANCIAL RESULTS
GERMANTOWN, MD, February 29, 2024 —Senseonics Holdings, Inc.
(NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous
glucose monitoring (CGM) systems for people with diabetes, today reported financial results for the quarter and full year ended December 31,
2023.
Recent Highlights & Accomplishments:
| · | Generated revenue of $8.0 million in the fourth quarter of 2023, representing growth of 44% compared to the prior year period and
revenue of $22.4 million in the full year 2023, representing growth of 37% compared to 2022 |
| · | Brian Hansen appointed President of CGM at Ascensia Diabetes Care, leading the newly created independent business unit and its dedicated
resources and reporting directly to PHC Group, to strengthen Eversense commercial execution |
| · | Medicare expanded access to the Eversense E3 CGM System through implementation of Local Coverage Determinations by three Medicare
Administrative Contractors (MACs) providing coverage for implantable CGM for basal only patients |
| · | Completed the ENHANCE pivotal trial in preparation of the FDA regulatory filing for the 365-day Eversense system expected to be filed
in the coming weeks. |
| · | Drew an additional $10.0 million on the loan facility with Hercules Capital, Inc. further strengthening the balance
sheet |
“2023 was a successful year across the business
for Senseonics. We completed the ENHANCE clinical trial and data analysis to support the imminent FDA submission for our 365-day system,
secured expanded Eversense coverage from UnitedHealthcare and Medicare, and strengthened our balance sheet to provide additional financial
flexibility to continue executing our business plan,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics.
“We are excited about Ascensia’s appointment of Brian Hansen, an industry veteran in the diabetes space with a successful
track record of commercializing advanced technologies, who we believe can lead the acceleration of adoption of Eversense. We believe the
robust Eversense product innovation cycle, including expected approvals of the iCGM designation for the 180-day product and the 365-day
product and the anticipated commercial launch of the 365-day product in Q4, will offer substantial additional benefits to diabetes patients
and positions Senseonics for its next phase of growth.”
Fourth Quarter 2023 Results:
Total revenue for the fourth quarter of 2023 was
$8.0 million compared to $5.6 million for the fourth quarter of 2022. U.S. revenue was $6.1 million in the fourth quarter of 2023 compared
to $3.6 million in the prior year period, and revenue outside the U.S. was $1.9 million in the fourth quarter of 2023 compared to $2.0
million in the prior year period.
Fourth quarter 2023 gross profit of $1.1 million
increased from $0.6 million for the fourth quarter of 2022. The increase in gross margin was primarily driven by an increase in revenue
as volumes increased.
Fourth quarter 2023 sales and marketing and general
and administrative expenses decreased by $0.5 million year-over-year, to $7.3 million. The reduction was the result of efforts to manage
other general and administrative costs across the organization.
Fourth quarter 2023 research and development expenses
decreased by $0.9 million year-over-year, to $10.7 million. The decrease was primarily due to the completion of the ENHANCE pivotal trial.
Net loss was $17.2 million, or $0.03 per share,
in the fourth quarter of 2023 compared to net income of $11.6 million, or $0.02 per share, in the fourth quarter of 2022. Net income decreased
by $28.8 million due to the accounting for embedded derivatives, fair value adjustments and the exchange of a portion of the 2025 notes.
Full Year 2023 Results:
Total revenue for 2023 was $22.4 million compared to $16.4 million
in 2022. U.S. revenue was $14.1 million in 2023 compared to $7.5 million in the prior year, and revenue outside the U.S. was $8.3 million
in 2023 compared to $8.9 million in the prior year period.
Gross profit for 2023 was $3.1 million, an increase from $2.7 million
in 2022. The increase in gross margin was primarily driven by an increase to revenue as volumes increased.
Sales and marketing and general and administrative expenses for 2023
decreased by $1.7 million year-over-year, to $29.9 million. The reduction was the result of efforts to manage other general and administrative
costs across the organization.
Research and development expenses for 2023 increased
by $9.0 million year-over-year, to $48.8 million. The increase was primarily due to investments in our product pipeline for development
and clinical trials of next generation technologies.
Net loss was $60.4 million, or $0.11 per share,
in 2023 compared to net income of $142.1 million, or $0.30 per share, in 2022. Net income decreased by $202.5 million due to the accounting
for embedded derivatives, fair value adjustments and the exchange of a portion of the 2025 notes.
Cash, cash equivalents, short
and long-term investments were $109.4 million and outstanding indebtedness was $46.1
million as of December 31, 2023.
First Half 2024 Financial Outlook
Senseonics expects first half of 2024 global net
revenue to be nearly $10 million, representing growth of approximately 16% compared to the first half of 2023. Senseonics plans to provide
its full year 2024 financial outlook in the second quarter following a comprehensive analysis of the current commercial
dynamics by the new leadership at the Ascensia Diabetes Care CGM business unit and an updated view on product approval and launch timing and expectations.
Conference Call and Webcast Information:
Company management will host a conference call
at 4:30 pm (Eastern Time) today, February 29, 2024, to discuss these financial results and recent business developments. This conference
call can be accessed live by telephone or through Senseonics' website.
Live Teleconference Information:
Dial in number: 888-317-6003
Entry Number: 3711982
International dial in: 412-317-6061 |
Live Webcast Information:
Visit http://www.senseonics.com and
select the "Investor Relations" section |
A replay of the call can be accessed on Senseonics' website http://www.senseonics.com under
"Investor Relations."
About Senseonics
Senseonics Holdings, Inc. ("Senseonics")
is a medical technology company focused on the development and manufacturing of glucose monitoring products designed to transform lives
in the global diabetes community with differentiated, long-term implantable glucose management technology. Senseonics' CGM systems, Eversense®,
Eversense® XL and Eversense® E3 include a small sensor inserted completely under the skin that communicates
with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user's
smartphone.
Forward Looking Statements
Any statements in this press
release about future expectations, plans and prospects for Senseonics, including the revenue projections under "First Half 2024
Financial Outlook," statements about the changes in leadership within the Ascensia’s CGM business unit, potential strengthened
Eversense® commercial execution, statements regarding increasing patient access and patient and provider adoption, statements
regarding Senseonics’ product pipeline, expected regulatory approvals and timing of the potential commercial launch of the 365-day
product, statements regarding strengthening the Eversense® brand, and other statements containing the words "believe,"
“expect,” “intend,” “may,” “projects,” “will,” “planned,” and
similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995.
Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors,
including: uncertainties inherent in the execution of Ascensia’s independent business unit for the commercialization of Eversense®
E3 CGM system and other commercial initiatives, uncertainties in insurer, regulatory and administrative processes and decisions,
uncertainties inherent in the development and registration of new technology, uncertainties relating to the current economic environment
and such other factors as are set forth in the risk factors detailed in Senseonics’ Annual Report on Form 10-K for the year
ended December 31, 2023, the Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 and Senseonics’
other filings with the SEC under the heading “Risk Factors.” In addition, the forward-looking statements included in this
press release represent Senseonics’ views as of the date hereof. Senseonics anticipates that subsequent events and developments
will cause Senseonics’ views to change. However, while Senseonics may elect to update these forward-looking statements at some
point in the future, Senseonics specifically disclaims any obligation to do so except as required by law. These forward-looking statements
should not be relied upon as representing Senseonics’ views as of any date subsequent to the date hereof.
Investor Contact
Philip Taylor
Gilmartin Group
415-937-5406
Investors@senseonics.com
Senseonics Holdings, Inc.
Consolidated Balance Sheets
(in thousands, except
for share and per share data)
| |
December 31, | |
| |
2023 | | |
2022 | |
Assets | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 75,709 | | |
$ | 35,793 | |
Short term investments, net | |
| 33,747 | | |
| 108,222 | |
Accounts receivable, net | |
| 808 | | |
| 127 | |
Accounts receivable, net - related parties | |
| 3,724 | | |
| 2,324 | |
Inventory, net | |
| 8,776 | | |
| 7,306 | |
Prepaid expenses and other current assets | |
| 7,266 | | |
| 7,428 | |
Total current assets | |
| 130,030 | | |
| 161,200 | |
| |
| | | |
| | |
Deposits and other assets | |
| 7,006 | | |
| 3,108 | |
Long term investments, net | |
| — | | |
| 12,253 | |
Property and equipment, net | |
| 1,184 | | |
| 1,112 | |
Total assets | |
$ | 138,220 | | |
$ | 177,673 | |
| |
| | | |
| | |
Liabilities and Stockholders’ Equity (Deficit) | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 4,568 | | |
$ | 419 | |
Accrued expenses and other current liabilities | |
| 11,744 | | |
| 14,616 | |
Accrued expenses and other current liabilities, related parties | |
| 945 | | |
| 837 | |
Note payable, current portion, net | |
| — | | |
| 15,579 | |
Derivative liability, current portion | |
| — | | |
| 20 | |
Total current liabilities | |
| 17,257 | | |
| 31,471 | |
| |
| | | |
| | |
Long-term debt and notes payables, net | |
| 41,195 | | |
| 56,383 | |
Derivative liabilities | |
| 102 | | |
| 52,050 | |
Other liabilities | |
| 6,214 | | |
| 2,689 | |
Total liabilities | |
| 64,768 | | |
| 142,593 | |
| |
| | | |
| | |
Commitments and contingencies | |
| | | |
| | |
| |
| | | |
| | |
Preferred stock and additional paid-in-capital, subject to possible redemption: $0.001 par value per share; 12,000 shares and 12,000 shares issued and outstanding as of December 31, 2023 and December 31, 2022 | |
| 37,656 | | |
| 37,656 | |
Total temporary equity | |
| 37,656 | | |
| 37,656 | |
| |
| | | |
| | |
Stockholders’ equity (deficit): | |
| | | |
| | |
Common stock, $0.001 par value per share; 900,000,000 shares authorized as of December 31, 2023 and December 31, 2022; 530,364,237 shares and 479,637,138 shares issued and outstanding as of December 31, 2023 and December 31, 2022 | |
| 530 | | |
| 480 | |
Additional paid-in capital | |
| 904,535 | | |
| 806,488 | |
Accumulated other comprehensive loss | |
| (11 | ) | |
| (678 | ) |
Accumulated deficit | |
| (869,258 | ) | |
| (808,866 | ) |
Total stockholders' equity (deficit) | |
| 35,796 | | |
| (2,576 | ) |
Total liabilities, temporary equity and
stockholders’ equity (deficit) | |
$ | 138,220 | | |
$ | 177,673 | |
Senseonics Holdings, Inc.
Consolidated Statements of Operations and Comprehensive
(Loss) Income
(in thousands, except for share and per share
data)
| |
Years Ended | |
| |
December 31, | |
| |
2023 | | |
2022 | |
Revenue, net | |
$ | 1,655 | | |
$ | 656 | |
Revenue, net - related parties | |
| 20,735 | | |
| 15,733 | |
Total revenue | |
| 22,390 | | |
| 16,389 | |
Cost of sales | |
| 19,299 | | |
| 13,663 | |
Gross profit | |
| 3,091 | | |
| 2,726 | |
| |
| | | |
| | |
Expenses: | |
| | | |
| | |
Research and development expenses | |
| 48,752 | | |
| 39,719 | |
Selling, general and administrative expenses | |
| 29,942 | | |
| 31,634 | |
Operating loss | |
| (75,603 | ) | |
| (68,627 | ) |
Other income (expense), net: | |
| | | |
| | |
Interest income | |
| 5,362 | | |
| 1,824 | |
Gain (Loss) on fair value adjustment of option | |
| — | | |
| 43,745 | |
Exchange related gain, net | |
| 14,109 | | |
| — | |
Gain (Loss) on extinguishment of debt and option | |
| — | | |
| (101 | ) |
Interest expense | |
| (11,110 | ) | |
| (18,703 | ) |
Gain (Loss) on change in fair value of derivatives | |
| 6,648 | | |
| 184,221 | |
Impairment cost | |
| — | | |
| (138 | ) |
Other income (expense) | |
| 202 | | |
| (102 | ) |
Total other income, net | |
| 15,211 | | |
| 210,746 | |
| |
| | | |
| | |
Net (Loss) Income | |
| (60,392 | ) | |
| 142,119 | |
Other comprehensive income (loss) | |
| | | |
| — | |
Unrealized gain (loss) on marketable securities | |
| 667 | | |
| (466 | ) |
Total other comprehensive gain (loss) | |
| 667 | | |
| (466 | ) |
Total comprehensive (loss) income | |
$ | (59,725 | ) | |
$ | 141,653 | |
| |
| | | |
| | |
Basic net (loss) income per common share | |
$ | (0.11 | ) | |
$ | 0.30 | |
Basic weighted-average shares outstanding | |
| 567,974,492 | | |
| 467,952,475 | |
| |
| | | |
| | |
Diluted net loss per common share | |
$ | (0.11 | ) | |
$ | (0.11 | ) |
Diluted weighted-average shares outstanding | |
| 567,974,492 | | |
| 618,205,605 | |
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