Senseonics Holdings, Inc. Announces Business Updates
2024年1月3日 - 6:05AM
ビジネスワイヤ(英語)
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 announced operational and financial
business updates.
Recent Highlights & Accomplishments:
- Generated preliminary unaudited fourth quarter revenue of
approximately $8.0 million, and unaudited full year 2023 total
revenue of approximately $22.0 million
- Completed data analysis of ENHANCE trial and determined to
advance to the next generation sensor platform as the underlying
technology used in the 365-day and future products
- Plan to review final data and submit application for regulatory
approval to the FDA with target of 365-day once per week
calibration product submission by the end of the first quarter of
2024
- PHC Group continues to prioritize building its dedicated CGM
organization with additional capabilities and leadership, intended
to strengthen focus and performance
- Closed an additional $10.0 million draw on the loan facility
with Hercules Capital, Inc. in the fourth quarter, further
enhancing liquidity
“Our progress in 2023 represents continued execution across our
strategic initiatives to advance both the adoption of Eversense and
our product development programs for the world’s first and only
long-term CGM. Significant new lead generation from advertising
campaign activities in the fourth quarter by our global commercial
partner Ascensia Diabetes Care demonstrated strong patient response
to the Eversense message. Now Ascensia is working to accelerate and
improve the conversion of those leads by enhancing its
CGM-dedicated commercial infrastructure,” said Tim Goodnow, PhD,
President and Chief Executive Officer of Senseonics. “As we look
ahead to 2024, we expect Ascensia to upgrade lead conversions so
they can work down their current inventory received in the fourth
quarter to support demand through the upcoming product innovation
cycle. We are targeting FDA submission of a 365-day, once a week
calibration product and expect this product to drive a positive
inflection in healthcare provider adoption and patient demand. We
believe that leveraging this next-generation sensor platform, which
is also the basis for our planned Gemini and Freedom systems, will
provide development advantages in future product development cycles
and support the long-term growth and adoption of Eversense.”
2023 Financial Results
The Company currently expects to report revenues of
approximately $8.0 million for the fourth quarter 2023 and full
year 2023 total revenue of approximately $22.0 million. The
Company’s unaudited balance of cash, cash equivalents and
marketable securities as of December 31, 2023, is expected to be
approximately $109.8 million. The Company expects to report its
full fourth quarter and fiscal year 2023 financial results in the
ordinary course later this quarter. The preliminary financial
results described in this update have not been audited and are
subject to adjustment based on the Company’s completion of year-end
financial close processes.
Considerations for 2024 Growth Outlook
The Company also plans to provide financial guidance for 2024
with the full fiscal year 2023 financial results. Factors impacting
expected positive revenue growth in 2024 include the most current
assessments of (i) plans with respect to further spending on the
DTC marketing campaign to generate leads, (ii) status of Ascensia’s
efforts to strengthen its capacity and capabilities to improve lead
conversion, (iii) Ascensia’s progress in working through current,
increased inventory levels, (iv) the status of other sales and
marketing initiatives, and (v) refined visibility of the timeline
and specifications for the regulatory submission of the Company’s
next generation longer duration product and the plans for
commercial transition to that product.
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 Q42023 and full
year 2023 revenue expectations, statements regarding PHC Group’s
building of it’s dedicated CGM business unit and Ascensia’s other
efforts to improvement lead conversion and other performance
measures, statements regarding the timelines and expectations with
respect to the planned regulatory submission for the next
generation product, statements regarding other product development
programs and pipeline, statements regarding growth and adoption 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: the possibility of adjustments to financial
results in connection with the finalization and audit of the
Company’s 2023 financial statements, uncertainties inherent in the
ongoing commercialization of the Eversense product, uncertainties
inherent in PHC Group’s development of a dedicated CGM business,
uncertainties inherit in Ascensia’s performance and other
commercial initiatives, including the ability to hire, retain and
effectively incentivize the dedicated CGM workforce, uncertainties
in the regulatory approval process, 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, 2022, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240102974276/en/
Investor Contact Philip Taylor Gilmartin Group
415-937-5406 Investors@senseonics.com
Senseonics (AMEX:SENS)
過去 株価チャート
から 4 2024 まで 5 2024
Senseonics (AMEX:SENS)
過去 株価チャート
から 5 2023 まで 5 2024