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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): November 7, 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 November 7, 2024, Senseonics Holdings, Inc.
(the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 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: November 7, 2024 |
SENSEONICS HOLDINGS, INC. |
|
|
|
By: |
/s/ Rick Sullivan |
|
Name: |
Rick Sullivan |
|
Title: |
Chief Financial Officer |
Exhibit 99.1
Senseonics Holdings, Inc. Reports Third
Quarter 2024 Financial Results
GERMANTOWN,
Md., November 7, 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 third quarter ended September 30, 2024.
Recent Highlights & Accomplishments:
| · | Eversense®
365 approved in the US as an integrated continuous glucose monitoring (iCGM) system
for people with Type 1 and Type 2 diabetes |
| · | Commercialization, now in process, driven by Senseonics’ global commercial partner, Ascensia Diabetes
Care, a subsidiary of PHC Holdings Corporation |
| · | Mercy health system inserted the first commercial Eversense 365 patient and anticipates that up to 30,000
of Mercy’s patients could benefit from a CGM system |
| · | Hosted
KOL webinar on October 25th, highlighting
clinicians’ perspectives on Eversense 365 and Mercy collaboration as a case study for
other cost-conscious health systems |
| · | Acquired sensor insertion network assets
of NPG to begin transitioning nurse practitioners to Eon Care business in order to support greater patient access and convenience |
| · | Raised gross proceeds of more than $20 million from equity offerings to strengthen the balance sheet
and extend cash runway |
| · | Executed a restructuring process with a target cash operating expense reduction of $10M in 2025 |
| · | Generated global revenue of $4.3 million in the third quarter and began U.S. winddown of Eversense
E3 to prepare transition to Eversense 365 |
“We received FDA approval for Eversense 365 in the third quarter,
and Mercy completed the first commercial patient insertion of our new sensor last month. This marks a significant achievement for Senseonics
and establishes us as the world’s first and only 365-day CGM,” said Tim Goodnow, PhD, President and Chief Executive Officer
of Senseonics. “In the first week after approval, we received the highest influx of inquiries in Senseonics’ history,
and early feedback from clinicians has been extremely positive. While we are still in the early days of the launch, we are encouraged
by the higher than expected number of healthcare provider leads and inbound interest from KOLs. Further, the recent financings and anticipated
savings from restructuring lengthen our runway. Together, these accomplishments position us well for a transformational 2025.”
Brian
Hansen, President of CGM at Ascensia Diabetes Care, remarked, “Ascensia is strongly committed to providing customers
with products that meet the highest standards of accuracy, precision, and reliability. Eversense 365 meets those criteria and provides
a truly unique solution for patients with Type 1 and Type 2 diabetes. For our sales team, it’s easy to explain 365’s key points
of differentiation- One year, One CGM. Removable transmitter with once a week calibration. We are working hand in hand with Senseonics
management to ensure a successful launch of Eversense 365, and we are thrilled to see such strong early enthusiasm for this innovative
and differentiated technology.”
Third Quarter 2024 Results:
Total revenue for the third quarter of 2024 was $4.3 million compared
to $6.1 million for the third quarter of 2023. U.S. revenue was $2.4 million in the third quarter of 2024
compared to $3.9 million in the prior year period, and revenue outside the U.S. was $1.9 million in the
third quarter of 2024 compared to $2.2 million in the prior year period. During the third quarter, inventory dynamics associated
with the 365-day product launch impacted product sales, as we began reducing E3 inventory in anticipation of transition to 365-day insertions.
Third quarter 2024 gross loss of $4.1 million compared to gross
profit of $1.2 million for the third quarter of 2023. The decrease in gross profit was primarily driven by one time charges
of $4.8 million associated with the transition from Eversense E3 to Eversense 365.
Third quarter 2024 sales and marketing and general and administrative
expenses increased by $0.9 million year-over-year, to $8.3 million. The increase was primarily driven by personnel and
consultant costs.
Third quarter 2024 research and development expenses decreased by $2.3
million year-over-year, to $10.5 million. The decrease was primarily due to a reduction in clinical studies and support services.
Net loss was $24.0 million, or $0.04 per share, in the
third quarter of 2024 compared to net loss of $24.1 million, or $0.04 per share, in the third quarter of 2023. Net loss
decreased by $0.1 million due to lower research and development expenses offset by one-time charges associatied with the transition
from Eversense E3 to Eversense 365.
Cash, cash equivalents, restricted cash and short-term investments
were $74.8 million and outstanding indebtedness was $55.9 million as of September 30, 2024. Subsequent to the
end of the third quarter of 2024, Senseonics received gross proceeds of $16.0 million from a recent financing.
Full Year 2024 Financial Outlook
Senseonics expects full-year 2024 global net revenue to be approximately $22
million as we begin to transition U.S. patients to Eversense 365 following approval in late Q3. The full-year 2024 financial outlook
assumes more than doubling the U.S. new patient starts and increasing the global installed base by approximately 50% in 2024
compared to 2023. During the third quarter, inventory dynamics associated with the 365-day product launch impacted product sales, as we
began reducing E3 inventory in anticipation of transition to 365-day insertions. Sales are expected to accelerate in the fourth quarter
based on anticipated initial 365-day product demand and the initial ramp of the Mercy collaboration. Cash utilization in 2024 is expected
to be consistent with 2023 at approximately $70 million.
Conference Call and Webcast Information:
Company management
will host a conference call at 4:30 pm (Eastern Time) today, November 7, 2024, to discuss these financial results and recent business
developments. Investors interested in listening to the conference call may do so by accessing a live and archived webcast of the event
at this link. Individuals interested in participating in the call via telephone may access
the call by dialing +1-800-445-7795 (+1-203-518-9856 for those outside the U.S.) and referencing Conference ID SENSQ3. A replay of the
call can be accessed on Senseoncs’ 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®
365 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.
About Eversense
The
Eversense® Continuous Glucose Monitoring (CGM) Systems are indicated for continually measuring glucose levels for up to
365 days for Eversense® 365 and 180 days for Eversense® E3 in persons with diabetes age 18 and older. The
systems are indicated for use to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions. Fingerstick BG
measurements are still required for calibration primarily one time per week after day 14 for Eversense® 365 and one time
per day after day 21 for Eversense® E3, and when symptoms do not match CGM information or when taking medications of the
tetracycline class. The sensor insertion and removal procedures are performed by a health care provider. The Eversense CGM Systems are
prescription devices; patients should talk to their health care provider to learn more. For important safety information, see https://www.eversensediabetes.com/safety-info/.
About Ascensia Diabetes
Care
Ascensia Diabetes Care is a global company focused
entirely on helping people with diabetes. Our mission is to empower those living with diabetes through innovative solutions that simplify
and improve their lives.
We are home to the world-renowned CONTOUR®
portfolio of blood glucose monitoring systems and the exclusive global distribution partner for the Eversense® Continuous
Glucose Monitoring Systems from Senseonics. These products combine advanced technology with user-friendly functionality to help people
with diabetes manage their condition and make a positive difference to their lives. As a trusted partner in the diabetes community, we
collaborate closely with healthcare professionals and other partners to ensure our products meet the highest standards of accuracy, precision
and reliability, and that we conduct our business compliantly and with integrity.
Ascensia is a member of PHC Group and was established
in 2016 through the acquisition of Bayer Diabetes Care by PHC Holdings Corporation. Ascensia products are sold in more than 100 countries.
Ascensia has around 1,400 employees and operations in 29 countries.
For
further information, please visit the Ascensia Diabetes Care website at: http://www.ascensia.com
About PHC Holdings Corporation
PHC
Holdings Corporation (TSE 6523) is a global healthcare company with a mission of contributing to the health of society through healthcare
solutions that have a positive impact and improve the lives of people. Its subsidiaries (referred to collectively as PHC Group) include
PHC Corporation, Ascensia Diabetes Care Holdings AG, Epredia Holdings Ltd., LSI Medience Corporation, Mediford Corporation, and Wemex.
Together, these companies develop, manufacture, sell and service solutions across diabetes management, healthcare solutions, life sciences
and diagnostics. PHC Group’s consolidated net sales in FY2023 were JPY 353.9 billion with global distribution of products and services
in more than 125 countries. www.phchd.com
|
©2024
Ascensia Diabetes Care Holdings AG. All right reserved. Ascensia, the Ascensia Diabetes Care logo and Contour are trademarks and/or
registered trademarks of Ascensia Diabetes Care Holdings AG. |
About Mercy
Mercy,
one of the 20 largest U.S. health systems and named the top large system in the U.S. for excellent patient experience
by NRC Health, serves millions annually with nationally recognized care and one of the nation’s largest and highest performing
Accountable Care Organizations in quality and cost. Mercy is a highly integrated, multi-state health care system including more than
50 acute care and specialty (heart, children’s, orthopedic and rehab) hospitals, convenient and urgent care locations, imaging
centers and pharmacies. Mercy has over 900 physician practice locations and outpatient facilities, more than 4,500 physicians and advanced
practitioners and 50,000 co-workers serving patients and families across Arkansas, Kansas, Missouri and Oklahoma.
Mercy also has clinics, outpatient services and outreach ministries in Arkansas, Louisiana, Mississippi and Texas.
In fiscal year 2023 alone, Mercy provided more than half a billion dollars of free care and other community benefits, including traditional
charity care and unreimbursed Medicaid.
Forward Looking Statements
Any
statements in this press release about future expectations, plans and prospects for Senseonics, including the revenue and cash
projections, assumptions related to U.S. new patient starts and the global installed base under the heading “Full Year 2024
Financial Outlook,” statements regarding plans, timing and success of the commercial launch of the 365-day system, statements
regarding increasing patient access and convenience, statements regarding potential users of CGM at health systems, statements
regarding the attributes experienced by people with diabetes and differentiating the system from short-term CGM, statements
regarding the integration of the Eversense CGM solution within the Mercy health care system and the adoption and/or growth of
Eversense, 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 and roll-out of new technology and solutions,
uncertainties inherent in finalizing integration and commercial terms and coordinations with health systems and other new
collaboration partners and third parties, uncertainties inherent in the ongoing commercialization of the Eversense product and the
expansion of the Eversense product and Senseonics' activities, 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 and subsequent quarterly reports on Form 10-Q filed 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.
Senseonics Investor Contact
Jeremy Feffer
LifeSci Advisors
investors@senseonics.com
Senseonics Holdings, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
| |
September 30, | | |
December 31, | |
| |
2024 | | |
2023 | |
| |
| (unaudited) | | |
| | |
Assets | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 27,106 | | |
$ | 75,709 | |
Restricted cash | |
| 315 | | |
| — | |
Short term investments, net | |
| 47,375 | | |
| 33,747 | |
Accounts receivable, net | |
| 1,523 | | |
| 808 | |
Accounts receivable, net - related parties | |
| 2,507 | | |
| 3,724 | |
Inventory, net | |
| 3,207 | | |
| 8,776 | |
Prepaid expenses and other current assets | |
| 5,665 | | |
| 7,266 | |
Total current assets | |
| 87,698 | | |
| 130,030 | |
| |
| | | |
| | |
Deposits and other assets | |
| 5,209 | | |
| 7,006 | |
Property and equipment, net | |
| 3,424 | | |
| 1,184 | |
Total assets | |
$ | 96,331 | | |
$ | 138,220 | |
Liabilities and Stockholders’ (Deficit) Equity | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 2,107 | | |
$ | 4,568 | |
Accrued expenses and other current liabilities | |
| 12,578 | | |
| 11,744 | |
Accrued expenses and other current liabilities, related parties | |
| 1,448 | | |
| 945 | |
Notes payable, current portion, net | |
| 19,376 | | |
| — | |
Total current liabilities | |
| 35,509 | | |
| 17,257 | |
| |
| | | |
| | |
Long-term debt and notes payables, net | |
| 34,448 | | |
| 41,195 | |
Derivative liabilities | |
| — | | |
| 102 | |
Other liabilities | |
| 5,899 | | |
| 6,214 | |
Total liabilities | |
| 75,856 | | |
| 64,768 | |
| |
| | | |
| | |
Preferred stock and additional paid-in-capital, subject to possible redemption: $0.001 par value per share; 12,000 shares authorized and 12,000 shares issued and outstanding as of September 30, 2024 and December 31, 2023 | |
| 37,656 | | |
| 37,656 | |
Total temporary equity | |
| 37,656 | | |
| 37,656 | |
| |
| | | |
| | |
Commitments and contingencies | |
| | | |
| | |
| |
| | | |
| | |
Stockholders’ (deficit) equity: | |
| | | |
| | |
Common stock, $0.001 par value per share; 1,400,000,000 shares and 900,000,000 shares authorized as of September 30, 2024 and December 31, 2023; 545,612,780 shares and 530,364,237 shares issued and outstanding as of September 30, 2024 and December 31, 2023 | |
| 546 | | |
| 530 | |
Additional paid-in capital | |
| 914,637 | | |
| 904,535 | |
Accumulated other comprehensive income (loss) | |
| 34 | | |
| (11 | ) |
Accumulated deficit | |
| (932,398 | ) | |
| (869,258 | ) |
Total stockholders’ (deficit) equity | |
| (17,181 | ) | |
| 35,796 | |
Total liabilities and stockholders’ (deficit) equity | |
$ | 96,331 | | |
$ | 138,220 | |
Senseonics Holdings, Inc.
Unaudited
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
| |
Three Months Ended | | |
Nine Months Ended | |
| |
September 30, | | |
September 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Revenue, net | |
$ | 955 | | |
$ | 426 | | |
$ | 2,322 | | |
$ | 1,176 | |
Revenue, net - related parties | |
| 3,308 | | |
| 5,671 | | |
| 11,853 | | |
| 13,184 | |
Total revenue | |
| 4,263 | | |
| 6,097 | | |
| 14,175 | | |
| 14,360 | |
Cost of sales | |
| 8,314 | | |
| 4,925 | | |
| 17,593 | | |
| 12,358 | |
Gross (loss) profit | |
| (4,051 | ) | |
| 1,172 | | |
| (3,418 | ) | |
| 2,002 | |
| |
| | | |
| | | |
| | | |
| | |
Expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development expenses | |
| 10,546 | | |
| 12,769 | | |
| 31,784 | | |
| 38,003 | |
Selling, general and administrative expenses | |
| 8,250 | | |
| 7,425 | | |
| 25,369 | | |
| 22,598 | |
Operating loss | |
| (22,847 | ) | |
| (19,022 | ) | |
| (60,571 | ) | |
| (58,599 | ) |
Other (expense) income, net: | |
| | | |
| | | |
| | | |
| | |
Interest income | |
| 1,010 | | |
| 1,460 | | |
| 3,584 | | |
| 3,879 | |
Exchange related (loss) gain, net | |
| — | | |
| (4,569 | ) | |
| — | | |
| 14,207 | |
Interest expense | |
| (2,133 | ) | |
| (2,425 | ) | |
| (6,266 | ) | |
| (9,388 | ) |
Gain on change in fair value of derivatives | |
| — | | |
| 438 | | |
| 102 | | |
| 6,505 | |
Other (expense) income | |
| (6 | ) | |
| 15 | | |
| 11 | | |
| 194 | |
Total other (expense) income, net | |
| (1,129 | ) | |
| (5,081 | ) | |
| (2,569 | ) | |
| 15,397 | |
| |
| | | |
| | | |
| | | |
| | |
Net Loss | |
| (23,976 | ) | |
| (24,103 | ) | |
| (63,140 | ) | |
| (43,202 | ) |
Other comprehensive loss | |
| | | |
| | | |
| | | |
| | |
Unrealized gain on marketable securities | |
| 41 | | |
| 61 | | |
| 45 | | |
| 619 | |
Other comprehensive gain | |
| 41 | | |
| 61 | | |
| 45 | | |
| 619 | |
Total comprehensive loss | |
$ | (23,935 | ) | |
$ | (24,042 | ) | |
$ | (63,095 | ) | |
$ | (42,583 | ) |
| |
| | | |
| | | |
| | | |
| | |
Basic net loss per common share | |
$ | (0.04 | ) | |
$ | (0.04 | ) | |
$ | (0.10 | ) | |
$ | (0.08 | ) |
Basic weighted-average shares outstanding | |
| 620,897,955 | | |
| 592,452,262 | | |
| 617,370,311 | | |
| 552,703,546 | |
| |
| | | |
| | | |
| | | |
| | |
Diluted net loss per common share | |
$ | (0.04 | ) | |
$ | (0.04 | ) | |
$ | (0.10 | ) | |
$ | (0.08 | ) |
Diluted weighted-average shares outstanding | |
| 620,897,955 | | |
| 592,452,262 | | |
| 617,370,311 | | |
| 552,703,546 | |
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