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 associated 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 Senseonics’ website
http://www.senseonics.com under “Investor Relations.”
About SenseonicsSenseonics
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 EversenseThe 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
CareAscensia 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
CorporationPHC 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 MercyMercy, 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 FefferLifeSci
Advisorsinvestors@senseonics.com
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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’ equity |
$ |
96,331 |
|
|
$ |
138,220 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Senseonics Holdings, Inc.Unaudited Condensed Consolidated
Statements of Operations and Comprehensive Loss(in thousands,
except share and per share data) |
|
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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 |
|
Senseonics (AMEX:SENS)
Graphique Historique de l'Action
De Nov 2024 à Déc 2024
Senseonics (AMEX:SENS)
Graphique Historique de l'Action
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