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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):
May 13, 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 May 13, 2024, Senseonics Holdings, Inc.
(the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2024, 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: May 13, 2024 |
SENSEONICS HOLDINGS, INC. |
|
|
|
By: |
/s/ Rick Sullivan |
|
Name: |
Rick Sullivan |
|
Title: |
Chief Financial Officer |
Exhibit 99.1
SENSEONICS HOLDINGS, INC. REPORTS FIRST QUARTER 2024 FINANCIAL
RESULTS
GERMANTOWN,
MD, May 13, 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 ended March 31, 2024.
Recent Highlights & Accomplishments:
| · | Generated revenue of $5.1 million in the first quarter of 2024, representing growth of 22% compared to the prior year period |
| · | Announced integration of Eversense® CGM and the Eversense Remote Patient Monitoring (RPM) solution within St. Louis-based Mercy
health care system, a major healthcare provider serving three million patients annually, including 30,000 potential CGM users. The collaboration
aims to enhance patient outcomes and reduce healthcare costs for users and is being designed as a model to aid health systems in managing
large at-risk populations effectively and economically |
| · | Received iCGM (integrated CGM) designation for the Eversense System from the U.S, Food and Drug Administration, making Eversense the
first fully implantable continuous glucose monitoring system that can now be integrated with insulin pumps as part of an automated insulin
delivery system |
| · | Filed a 510(k) submission with the FDA for the next generation Eversense 365-day system for iCGM
designation |
“It
has been a very productive start to the year for Senseonics as we continue to expand the features of Eversense to benefit more
people with diabetes. The Eversense platform now sits in its strongest position ever, following receipt of the iCGM designation, the filing
of our next-generation 365-day system with the FDA, and the announcements of our Eversense RPM and collaboration with Mercy,” said
Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “We are proud Eversense was chosen by one of the largest
and most innovative health systems in the country to monitor risk and proactively treat both their type 1 and type 2 patients. Integrating
the longest-lasting CGM into a diabetes population management program, we are confident that Eversense can help improve patient outcomes
and lower the cost of care for the thousands of patients in the Mercy system who could benefit from CGM.”
First Quarter 2024 Results:
Total revenue for the first quarter of 2024 was
$5.1 million compared to $4.1 million for the first quarter of 2023. U.S. revenue was $3.7 million in the first quarter of 2024 compared
to $2.1 million in the prior year period, and revenue outside the U.S. was $1.4 million in the first quarter of 2024 compared to $2.0
million in the prior year period.
First quarter 2024 gross profit of $0.3 million
decreased from $0.4 million for the first quarter of 2023. The decrease in gross margin was primarily driven by an increase in fixed manufacturing
costs compared to the prior year quarter.
First quarter 2024 sales and marketing and general
and administrative expenses increased by $0.4 million year-over-year, to $8.1 million. The increase was primarily driven by costs related
to marketing initiatives.
First quarter 2024 research and development expenses
decreased by $2.0 million year-over-year, to $10.4 million. The decrease was primarily due to the completion of the ENHANCE pivotal trial.
Net loss was $18.9 million, or $0.03 per share,
in the first quarter of 2024 compared to net income of $1.3 million, or $0.00 per share, in the first quarter of 2023. Net income decreased
by $20.2 million due to the accounting for embedded derivatives, fair value adjustments and the exchange of a portion of the 2025 notes.
First Half 2024 Financial Outlook
Senseonics
continues to expect first half of 2024 global net revenue to be $10 million, representing growth of approximately 16% compared
to the first half of 2023.
The Company plans to provide its full year financial
outlook at an investor event to be scheduled during the upcoming American Diabetes Association Scientific Sessions on June 21-24,
2024 in Orlando, Florida.
Conference Call and Webcast Information:
Company management will host a conference call
at 4:30 pm (Eastern Time) today, May 13, 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: 7182212
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 regarding the integration of the Eversense CGM and the Eversense RPM solution within the Mercy health care system,
the adoption or growth of Eversense, and the potential to enhance patient outcomes and reduce healthcare costs, 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 the independent business unit of Ascensia Diabetes Care, the Company’s commercialization partner for Eversense, and other commercial
initiatives, uncertainties in insurer, regulatory and administrative processes and decisions, uncertainties inherent in the development
and registration of new technology and solutions, uncertainties inherent in finalizing integration and commercial terms with new partners
and other third parties, uncertainties inherent in the ongoing commercialization of the Eversense product and the expansion of the Eversense
product and a new RPM solution, uncertainties relating to the current economic environment and such other factors as are set forth in
the risk factors detailed in Senseonics' Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 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.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
| |
March 31, | | |
December 31, | |
| |
2024 | | |
2023 | |
| |
(unaudited) | | |
| |
Assets | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 90,544 | | |
$ | 75,709 | |
Restricted cash | |
| 316 | | |
| — | |
Short term investments, net | |
| 8,169 | | |
| 33,747 | |
Accounts receivable, net | |
| 1,001 | | |
| 808 | |
Accounts receivable, net - related parties | |
| 2,750 | | |
| 3,724 | |
Inventory, net | |
| 7,963 | | |
| 8,776 | |
Prepaid expenses and other current assets | |
| 7,434 | | |
| 7,266 | |
Total current assets | |
| 118,177 | | |
| 130,030 | |
| |
| | | |
| | |
Deposits and other assets | |
| 6,903 | | |
| 7,006 | |
Property and equipment, net | |
| 1,436 | | |
| 1,184 | |
Total assets | |
$ | 126,516 | | |
$ | 138,220 | |
Liabilities and Stockholders’ Equity | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 675 | | |
$ | 4,568 | |
Accrued expenses and other current liabilities | |
| 10,034 | | |
| 11,744 | |
Accrued expenses and other current liabilities, related parties | |
| 1,071 | | |
| 945 | |
Note payable, current portion, net | |
| 17,937 | | |
| — | |
Derivative liability, current portion | |
| 102 | | |
| — | |
Total current liabilities | |
| 29,819 | | |
| 17,257 | |
| |
| | | |
| | |
Long-term debt and notes payables, net | |
| 33,965 | | |
| 41,195 | |
Derivative liabilities | |
| — | | |
| 102 | |
Other liabilities | |
| 6,114 | | |
| 6,214 | |
Total liabilities | |
| 69,898 | | |
| 64,768 | |
| |
| | | |
| | |
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 March 31, 2024 and December 31, 2023 | |
| 37,656 | | |
| 37,656 | |
Total temporary equity | |
| 37,656 | | |
| 37,656 | |
| |
| | | |
| | |
Commitments and contingencies | |
| | | |
| | |
| |
| | | |
| | |
Stockholders’ equity: | |
| | | |
| | |
Common stock, $0.001 par value per share; 900,000,000 shares authorized as of March 31, 2024 and December 31, 2023; 530,817,549 shares and 530,364,237 shares issued and outstanding as of March 31, 2024 and December 31, 2023 | |
| 530 | | |
| 530 | |
Additional paid-in capital | |
| 906,569 | | |
| 904,535 | |
Accumulated other comprehensive loss | |
| (2 | ) | |
| (11 | ) |
Accumulated deficit | |
| (888,135 | ) | |
| (869,258 | ) |
Total stockholders’ equity | |
| 18,962 | | |
| 35,796 | |
Total liabilities and stockholders’ equity | |
$ | 126,516 | | |
$ | 138,220 | |
Senseonics Holdings, Inc.
Unaudited
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss)
(in thousands, except share and per share data)
| |
Three Months Ended | |
| |
March 31, | |
| |
2024 | | |
2023 | |
Revenue, net | |
$ | 589 | | |
$ | 313 | |
Revenue, net - related parties | |
| 4,458 | | |
| 3,824 | |
Total revenue | |
| 5,047 | | |
| 4,137 | |
Cost of sales | |
| 4,712 | | |
| 3,723 | |
Gross profit | |
| 335 | | |
| 414 | |
| |
| | | |
| | |
Expenses: | |
| | | |
| | |
Research and development expenses | |
| 10,438 | | |
| 12,405 | |
Selling, general and administrative expenses | |
| 8,129 | | |
| 7,718 | |
Operating loss | |
| (18,232 | ) | |
| (19,709 | ) |
Other (expense) income, net: | |
| | | |
| | |
Interest income | |
| 1,384 | | |
| 1,108 | |
Exchange related gain, net | |
| — | | |
| 18,776 | |
Interest expense | |
| (2,047 | ) | |
| (4,652 | ) |
Gain on change in fair value of derivatives | |
| — | | |
| 5,778 | |
Other income | |
| 18 | | |
| 23 | |
Total other (expense) income, net | |
| (645 | ) | |
| 21,033 | |
| |
| | | |
| | |
Net (Loss) Income | |
| (18,877 | ) | |
| 1,324 | |
Other comprehensive income | |
| | | |
| | |
Unrealized gain on marketable securities | |
| 9 | | |
| 458 | |
Total other comprehensive gain | |
| 9 | | |
| 458 | |
Total comprehensive (loss) income | |
$ | (18,868 | ) | |
$ | 1,782 | |
| |
| | | |
| | |
Basic net (loss) income per common share | |
$ | (0.03 | ) | |
$ | 0.00 | |
Basic weighted-average shares outstanding | |
| 614,588,546 | | |
| 497,473,222 | |
| |
| | | |
| | |
Diluted net (loss) per common share | |
$ | (0.03 | ) | |
$ | 0.00 | |
Diluted weighted-average shares outstanding | |
| 614,588,546 | | |
| 540,532,813 | |
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Senseonics (AMEX:SENS)
과거 데이터 주식 차트
부터 5월(5) 2024 으로 6월(6) 2024
Senseonics (AMEX:SENS)
과거 데이터 주식 차트
부터 6월(6) 2023 으로 6월(6) 2024