Senseonics Announces Business Update
December 23 2020 - 4:49PM
Business Wire
Senseonics Holdings, Inc. (NYSE American: SENS), a medical
technology company focused on the development and commercialization
of long-term, implantable continuous glucose monitoring (CGM)
systems for people with diabetes, announced today financial and
operational business updates.
Recent Developments
- Fourth quarter 2020 net revenue is expected to be approximately
$3.5 million, increased from the prior expectation of approximately
$2.5 million
- Received communication from the FDA explaining the reallocation
of agency resources to address Emergency Use Authorization (EUA)
applications for products related to the COVID-19 public health
emergency is affecting marketing application reviews, including the
Eversense 180-day product, which will be delayed by at least 60
days. This is consistent with what Senseonics understands other
medical technology companies have reported.
- Inclusion of Eversense Category III CPT codes in the Centers
for Medicare & Medicaid Services (CMS) 2021 Physician Fee
Schedule (PFS), establishing global payment for the device cost and
procedure fees for healthcare providers across the United
States
- Full year 2021 net revenue is expected to be between $12 and
$15 million, based on installed base, acceleration of Ascensia’s
commercial activities and other factors
- Reached agreement with Roche to facilitate transition of
distribution to Ascensia, as Roche sales conclude January 31, 2021,
including final purchases, transition support activities, and
resolution of other matters
- Highbridge second lien loan extinguished through completed
conversion of their second lien debt to common stock, simplifying
capital structure
“Strong fourth quarter performance was driven by sales in Europe
and supported by Ascensia’s initial US sales. In the first quarter
of next year our top priority is executing an orderly commercial
transition in Europe from Roche to Ascensia while maintaining
uninterrupted patient and provider service. On the regulatory front
we understand the FDA’s prioritization of Emergency Use
Authorization applications for products to help manage the COVID-19
pandemic. We remain confident that the PROMISE study demonstrates
that the excellent performance of the current Eversense system is
extended for up to 180 days, and that there still is potential for
a decision from the agency by the end of the end of the second
quarter,” said Tim Goodnow, PhD, President and Chief Executive
Officer of Senseonics. “The inclusion of implantable CGM in the
physician fee schedule for 2021 will improve access to Eversense
for Medicare patients who are uniquely suited to benefit from the
features of the system. Looking forward to 2021, while the US
patient population represents a substantial growth opportunity for
Senseonics and Ascensia, we ultimately expect OUS revenue to
continue to account for over half of total revenue.”
“We have established a strong commercial team integrated with
the Eversense operations across the US and our initial efforts have
been successful both with reinsertions of current patients and the
addition of new patients,” said Robert Schumm, President of
Ascensia Diabetes Care. “As we look to 2021, we intend to ramp up
our investment in the beginning of the new year to increase access
to the technology globally. We will be focused on expanding our
worldwide sales and marketing activities while building out a
comprehensive infrastructure to drive continued Eversense adoption.
We are excited to work with this enthusiastic group of healthcare
providers and patients who believe in the remarkable benefits of
the Eversense products.”
About Senseonics
Senseonics Holdings, Inc. is a medical technology company
focused on the design, development and commercialization of
transformational glucose monitoring products designed to help
people with diabetes confidently live their lives with ease.
Senseonics' CGM systems, Eversense® and Eversense® XL, 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 statements about
Senseonics’ expected net revenue for the fourth quarter of 2020 and
the full year of 2021, the timing and outcome of the potential
decision on the 180-day Eversense system from the FDA, improved
access to Eversense for Medicare patients, growth opportunities in
2021, the proportion of OUS revenue to total revenue, the potential
ramp of worldwide sales and marketing activities in 2021, 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 in the regulatory approval process, uncertainties
inherent in the commercial launch and commercial expansion of the
product, uncertainties in insurer, regulatory and administrative
processes and decisions, uncertainties in the duration and severity
of the COVID-19 pandemic, 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, 2019, Senseonics’ Quarterly
Report on Form 10-Q for the quarter ended September 30, 2020 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/20201223005557/en/
Senseonics Investor Contact Lynn Lewis or Philip Taylor
Investor Relations 415-937-5406 investors@senseonics.com
Senseonics Media Contact: Mirasol Panlilio 301-556-1631
Mirasol.panlilio@senseonics.com
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