Senseonics Holdings, Inc. (NYSE American: SENS), a medical
technology company focused on the development and commercialization
of the first and only long-term, implantable continuous glucose
monitoring (CGM) system for people with diabetes, today reported
financial results for the quarter ended March 31, 2020.
Recent Highlights & Accomplishments:
- Completed the PROMISE study generating data to be included in
the FDA Premarket Approval application for the Eversense XL system,
for use up to 180 days, in the U.S. with expected filing in late
summer
- Medicare Administrative Contractors (MAC) published favorable
draft Local Coverage Determination (LCD) for implantable CGM
devices. Four of seven MACs removed implantable CGM procedure codes
from non-coverage LCDs; three more MACs expected to take the same
steps
- Received positive coverage decisions for Eversense from several
Blue Cross Blue Shield Plans providing access to nearly 10 million
covered lives, bringing total covered lives in the U.S. to 171
million
- Commenced process to explore strategic alternatives to enhance
stakeholder value
- Entered into credit facilities providing $15.0 million of
immediate liquidity and access to an additional $5.0 million
“In the second half of March we began to experience significant
dislocation in the market because of the isolation efforts to
prevent the transmission of COVID-19. As part of the public health
considerations in response to the pandemic, most endocrinology
clinics transitioned to telehealth interactions with patients,
greatly limiting in-person visits and significantly reducing health
care providers’ ability to insert sensors for patients,” said Tim
Goodnow, PhD, President and Chief Executive Officer of Senseonics.
“These challenging market circumstances in combination with our
financial situation led the Board to the decision to explore
strategic alternatives for the company. Concurrent with this
process we took steps to reorganize and reprioritize our corporate
initiatives. To operate in the most efficient manner moving forward
we have temporarily suspended commercial activities in the U.S. for
new patients and have shifted our focus to long-term value creation
through product development and market access. We remain committed
to supporting our current patient base and ensuring the success of
Eversense in the marketplace.”
First Quarter 2020 Results:
In the first quarter of 2020, total net revenue was $36 thousand
compared to total net revenue of $3.4 million for the first quarter
of 2019. U.S. net revenue was $24 thousand after accounting for
gross to net reductions, primarily related to the Eversense Bridge
Program and COVID-19 relief concessions offered to several
strategic fulfillment partners for allowances up to a specified
amount if they are unable to sell-through Eversense given the
current healthcare environment. Net revenue outside the U.S. was
$12 thousand due to the deferral of orders by Roche. Gross revenue
for the first quarter of 2020 was $2.0 million, nearly all of which
was generated in the U.S.
First quarter 2020 gross profit decreased by $16.3 million
year-over-year, to ($19.6) million. The decrease in gross profit
was primarily due to increased cost of sales as a result of
impairment charges for inventory and related assets reflecting
uncertainty in demand forecasts from changes made to our
operational focus and current economic conditions.
First quarter 2020 sales and marketing expenses decreased by
$1.7 million year-over-year, to $11.1 million. The decrease was
primarily due to lower consulting and marketing expenses, offset
slightly by severance expenses due to the recent changes in
commercial activities.
First quarter 2020 research and development expenses increased
by $0.3 million year-over-year, to $7.4 million. The increase was
primarily driven by PROMISE clinical study costs and personnel
related expenses, offset slightly by a decline in general research
and development activities.
First quarter 2020 general and administrative expenses decreased
by $0.8 million year-over-year, to $5.7 million. The decrease was
primarily due to a decline in personnel related expenses.
Net loss was $42.6 million, or $0.21 per share, in the first
quarter of 2020, compared to $29.4 million, or $0.17 per share, in
the first quarter of 2019.
As of March 31, 2020, cash, cash equivalents and restricted cash
were $18.8 million and outstanding indebtedness was $98.7 million.
Subsequent to the quarter, the Company entered into two credit
facilities providing immediate gross proceeds of $15.0 million and
access to an additional $5.0 million. Pursuant to the Paycheck
Protection Program, the Company received $5.8 million of financing
to support payroll costs and other allowable expenses as defined
under the program. As of April 30, 2020, cash, cash equivalents and
restricted cash were approximately $30 million.
2020 Financial Outlook
On March 26, 2020, the company withdrew its financial guidance
because of the market disruption and uncertainty caused by the
COVID-19 pandemic.
Conference Call and Webcast Information
Company management will host a conference call at 4:30 pm
(Eastern Time) today, June 9, 2020, 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:
877-883-0383 Entry Number: 9741409 International dial in:
412-902-6506
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.”
The reporting of Senseonics Holdings, Inc.’s financial results
were delayed in accordance with the Securities and Exchange
Commission’s order for filing relief related to COVID-19.
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.
Non-GAAP Financial Measures
In accordance with U.S. GAAP, Senseonics reports revenue in its
financial statements on a net basis, which takes into account gross
to net reductions resulting from discount programs, such as the
Eversense Bridge Program. To supplement its unaudited condensed
consolidated financial statements, which are prepared and presented
in accordance with U.S. GAAP and present total revenue, net,
Senseonics is also providing investors with gross revenue and U.S.
gross revenue. These measures do not reflect the gross to net
reductions from these discount programs and, accordingly, may be
considered to be non-GAAP financial measures. The presentation of
these non-GAAP financial measures is not intended to be considered
in isolation or as a substitute for, or superior to, the financial
information prepared and presented in accordance with GAAP, and
Senseonics’ non-GAAP measures may be different from non-GAAP
measures used by other companies.
Senseonics uses these non-GAAP financial measures for financial
and operational decision-making. Senseonics’ management believes
that these non-GAAP financial measures provide meaningful
supplemental information regarding Senseonics’ performance and
provide better transparency on the impact of reimbursement and the
Eversense Bridge Program. Senseonics believes that both management
and investors benefit from referring to these non-GAAP financial
measures in assessing Senseonics’ performance and when planning,
forecasting, and analyzing future periods. For more information on
these non-GAAP financial measures, please see the reconciliation of
these non-GAAP financial measures to their nearest comparable GAAP
measures at the end of this press release.
Forward Looking Statements
Any statements in this press release about future expectations,
plans and prospects for Senseonics, including statements about
potential coverage decisions, including by three additional MACs,
the potential impact or meaning of coverage decisions, including
without limitation making Eversense available, claim adjudication,
and the potential life-enhancing benefits Eversense offers people
with diabetes, the potential FDA Premarket Approval application for
the Eversense XL system, and other statements containing the words
“believe,” “expect,” “intend,” “may,” “projects,” “will,” 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 development and regulatory
approval processes, 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 March 31, 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.
Senseonics Holdings,
Inc.
Unaudited Condensed
Consolidated Statements of Operations and Comprehensive
Loss
(in thousands, except share
and per share data)
Three Months Ended
March 31,
2020
2019
Revenue, net
$
31
$
1,243
Revenue, net - related parties
5
2,180
Total revenue
36
3,423
Cost of sales
19,670
6,733
Gross profit
(19,634
)
(3,310
)
Expenses:
Sales and marketing expenses
11,145
12,834
Research and development expenses
7,362
7,108
General and administrative expenses
5,690
6,516
Operating loss
(43,831
)
(29,768
)
Other income, net:
Interest income
209
627
Loss on extinguishment of debt
(4,546
)
—
Interest expense
(4,373
)
(2,034
)
Change in fair value of derivative
liabilities
10,311
2,072
Other expense
(363
)
(262
)
Total other income, net
1,238
403
Net loss
(42,593
)
(29,365
)
Total comprehensive loss
$
(42,593
)
$
(29,365
)
Basic and diluted net loss per common
share
$
(0.21
)
$
(0.17
)
Basic and diluted weighted-average shares
outstanding
203,745,974
176,954,116
Senseonics Holdings,
Inc.
Condensed Consolidated Balance
Sheets
(in thousands, except share
and per share data)
March 31,
December 31,
2020
2019
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
18,605
$
95,938
Restricted cash
200
—
Accounts receivable, net
991
3,239
Accounts receivable - related parties
5
7,140
Inventory, net
4,995
16,929
Prepaid expenses and other current
assets
5,740
4,512
Total current assets
30,536
127,758
Deposits and other assets
2,930
3,042
Property and equipment, net
1,803
2,001
Total assets
$
35,269
$
132,801
Liabilities and Stockholders’ Deficit
Current liabilities:
Accounts payable
$
2,490
$
4,285
Accrued expenses and other current
liabilities
15,371
18,636
Term Loans, net of discount
—
43,434
2025 Notes, net of discount
—
60,353
Total current liabilities
17,861
126,708
2023 Notes, net of discount
12,412
12,464
2025 Notes, net of discount
51,868
—
Other liabilities
2,089
2,278
Total liabilities
84,230
141,450
Commitments and contingencies
Stockholders’ deficit:
Common stock, $0.001 par value per share;
450,000,000 shares authorized; 204,444,835 and 203,452,812 shares
issued and outstanding as of March 31, 2020 and December 31,
2019
204
203
Additional paid-in capital
466,771
464,491
Accumulated deficit
(515,936
)
(473,343
)
Total stockholders' deficit
(48,961
)
(8,649
)
Total liabilities and stockholders’
deficit
$
35,269
$
132,801
Senseonics Holdings,
Inc.
Reconciliation of Total
Revenue, Net to Gross Revenue
(in thousands)
For the Three Months Ended
March 31, 2020
For the Three Months Ended
March 31, 2019
Revenue, net
$
36
$
3,423
Gross to net reductions
1,989
242
Gross revenue
$
2,025
$
3,665
Senseonics Holdings,
Inc.
Reconciliation of U.S.
Revenue, Net to U.S. Gross Revenue
(in thousands)
For the Three Months Ended
March 31, 2020
For the Three Months Ended
March 31, 2019
U.S. Revenue, net
$
24
$
816
Gross to net reductions
1,989
242
U.S. Gross revenue
$
2,013
$
1,058
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200609005766/en/
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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