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, today reported financial results
for the quarter ended September 30, 2020.
Recent Highlights & Accomplishments:
- Reinitiated Eversense® new patient sales and marketing
activities in the U.S. with Ascensia Diabetes Care on October 1,
2020
- Submitted Premarket Approval (PMA) supplement application for
the extension of the wearable life of the Eversense CGM System for
up to 180 days to the United States Food and Drug Administration
(FDA)
- Announced PROMISE study accuracy results for the 180-day
Eversense product, demonstrating mean absolute relative difference
(MARD) matching the performance of the current 90-day Eversense
system of 8.5%-9.6%
- Continued efforts to expand patient access resulted in positive
coverage decisions representing approximately 80% of covered lives
in the U.S. This includes Medicare patients following the issuance
of Local Coverage Determinations from all Medicare Administrative
Contractors ahead of the 2021 Medicare Physician Fee Schedule
Proposed Rule that will provide national coverage for implantable
CGMs
- Generated third quarter 2020 revenue of $767 thousand driven by
increased sensor reinsertions and supply orders from existing
patients compared to the second quarter of 2020
- Reduced third quarter operating expenses by $18.9 million,
compared to the prior year period, due to the execution of cost
reduction actions and the streamlined operational focus implemented
in late March 2020
- Entered into a $12.0 million equity line of credit with Energy
Capital
“In the third quarter we continued to efficiently support
Eversense users who understand the heightened importance of
glycemic control amid this pandemic. At the start of the fourth
quarter we initiated commercial activity with Ascensia. Following a
successful training program, the Ascensia sales force is now
calling on Eversense prescribers in pursuit of new commercial and
Medicare patients,” said Tim Goodnow, PhD, President and Chief
Executive Officer of Senseonics. “We believe the organizational
changes for Senseonics resulting from the worldwide strategic
commercial collaboration, in combination with additional cost
reduction initiatives, will continue to drive expense and cash burn
reductions in the future. Investment and resources are focused on
the approval of the 180-day Eversense system in the U.S. and
driving the development of the 365-day product where we are making
great strides with configuration optimization. Following our PMA
supplement submission and the early efforts with Ascensia we are
excited and well positioned for a potential launch of the 180-day
product in the first half of next year. We continue to drive
execution across the company, including our product development and
commercialization efforts with our partner Ascensia, while
supporting our approximately 5,000 active patients globally. With
our strategic partnership set we believe we are continuing to build
a compelling value proposition for patients with diabetes.”
Anticipated Key Milestones:
Q1 2021 – Proposed Medicare National Payment Schedule Q1 2021 –
Initiation of commercial activities outside of the U.S. by Ascensia
H1 2021 – Expected decision on approval of 180-day Eversense
product by FDA H1 2021 – Planned IDE approval of 365-day Eversense
clinical trial by FDA, including pediatric population H2 2021 –
Planned enrollment of 365-day Eversense clinical trial
Third Quarter 2020 Results:
In the third quarter of 2020, revenue was reduced due to the
temporary suspension of commercial operations in March in the U.S.
following restructuring of the organization to preserve cash, as
well as the effects of temporary patient deferments resulting from
the global pandemic. Total net revenue for the quarter was $767
thousand compared to total net revenue of $4.3 million for the
third quarter of 2019. U.S. net revenue was $509 thousand after
accounting for gross to net adjustments. Net revenue outside the
U.S. was $258 thousand due to the deferral of orders by Roche.
Third quarter 2020 gross profit increased by $4.2 million
year-over-year, to $835 thousand. The positive gross margin in the
quarter was primarily due to the ability to fill resupply orders
with existing written off inventory as existing patient reinsertion
rates were above the expectations established in the first quarter
of 2020 amid the onset of the COVID-19 pandemic.
Third quarter 2020 sales and marketing expenses decreased by
$8.3 million year-over-year, to $3.2 million. The decrease was
primarily due to the recent changes in commercial activities.
Third quarter 2020 research and development expenses decreased
by $6.5 million year-over-year, to $4.6 million. The decrease was
primarily driven by lower clinical study costs and personnel
related expenses.
Third quarter 2020 general and administrative expenses increased
by $0.1 million year-over-year, to $5.5 million. The increase was
primarily due to an increase in stock-based compensation
expenses.
Net loss was $23.4 million, or $0.10 per share, in the third
quarter of 2020, compared to $19.5 million, or $0.10 per share, in
the third quarter of 2019. Net loss increased by $3.9 million due
to a $22.9 million increase to other expenses primarily related to
the accounting of the company’s financings partially offset by a
$18.9 million decrease in loss from operations.
As of September 30, 2020, cash, cash equivalents and restricted
cash were $26.4 million and outstanding indebtedness was $123.4
million.
Conference Call and Webcast Information:
Company management will host a conference call at 4:30 pm
(Eastern Time) today, November 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:
Live Webcast
Information:
Dial in number: 888-243-4451
Visit http://www.senseonics.com and
Entry Number: 4128608
select the “Investor Relations”
section
International dial in: 412-542-4135
A replay of the call can be accessed on Senseonics’ website
http://www.senseonics.com under “Investor Relations.”
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 the
potential benefits of the Ascensia commercialization and
collaboration agreement, including future expense and cash burn
reductions, potential coverage decisions, the potential approval
and commercial launch of the 180-day Eversense system in the United
States, the development of the 365-day product, the timing of
future key milestones, including the proposed Medicare Physician
Fee Schedule Proposed Rule, the initiation of commercial activities
outside of the U.S. by Ascensia, the expected decision on approval
of the 180-day Eversense product by FDA, the planned IDE approval
of the 365-day Eversense clinical trial by FDA and the planned
enrollment of the 365-day Eversense clinical trial, 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 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, the necessity of
receiving stockholder approval that will be required in order to
raise all of the capital pursuant to the preferred stock and
certain debt transactions described in this release, 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.
Senseonics Holdings,
Inc.
Condensed Consolidated Balance
Sheets
(in thousands, except share
and per share data)
September 30,
December 31,
2020
2019
(unaudited)
Assets
Current assets:
Cash and cash equivalents
$
26,192
$
95,938
Restricted cash
200
—
Accounts receivable, net
250
3,239
Accounts receivable - related parties
251
7,140
Inventory, net
4,284
16,929
Prepaid expenses and other current
assets
4,588
4,512
Total current assets
35,765
127,758
Purchase put option
4,224
—
Deposits and other assets
2,409
3,042
Property and equipment, net
1,665
2,001
Total assets
$
44,063
$
132,801
Liabilities and Stockholders’
Deficit
Current liabilities:
Accounts payable
$
949
$
4,285
Accrued expenses and other current
liabilities
9,153
18,636
Term Loans, net
—
43,434
2025 Notes, net
—
60,353
Total current liabilities
10,102
126,708
Long-term debt and notes payables, net
59,649
11,800
Derivative liabilities
24,590
664
Other liabilities
1,693
2,278
Total liabilities
96,034
141,450
Preferred stock and additional
paid-in-capital, subject to possible redemption: $0.001 par value
per share; 3,000 shares and 0 shares issued and outstanding as of
September 30, 2020 and December 31, 2019
2,811
—
Total temporary equity
2,811
—
Commitments and contingencies
Stockholders’ deficit:
Common stock, $0.001 par value per share;
450,000,000 shares authorized; 244,238,638 and 203,452,812 shares
issued and outstanding as of September 30, 2020 and December 31,
2019
244
203
Additional paid-in capital
491,853
464,491
Accumulated deficit
(546,879
)
(473,343
)
Total stockholders' deficit
(54,782
)
(8,649
)
Total liabilities and stockholders’
deficit
$
44,063
$
132,801
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,
2020
2019
2020
2019
Revenue, net
$
514
$
959
$
761
$
3,678
Revenue, net - related parties
253
3,360
303
8,671
Total revenue
767
4,319
1,064
12,349
Cost of sales
(68
)
7,659
21,006
23,552
Gross profit (loss)
835
(3,340
)
(19,942
)
(11,203
)
Expenses:
Sales and marketing expenses
3,234
11,560
17,521
38,573
Research and development expenses
4,568
11,076
15,726
28,688
General and administrative expenses
5,501
5,388
15,635
17,321
Operating loss
(12,468
)
(31,364
)
(68,824
)
(95,785
)
Other (expense) income, net:
Interest income
1
519
173
1,556
Loss on extinguishment and issuance of
debt
(9,527
)
(398
)
(20,458
)
(398
)
Interest expense
(3,632
)
(3,460
)
(11,560
)
(7,459
)
Debt issuance costs
(931
)
(3,344
)
(1,216
)
(3,344
)
Gain on fair value and change in fair
value of derivatives
3,520
19,186
29,069
26,147
Other expense
(391
)
(638
)
(720
)
(655
)
Total other (expense) income, net
(10,960
)
11,865
(4,712
)
15,847
Net loss
(23,428
)
(19,499
)
(73,536
)
(79,938
)
Total comprehensive loss
$
(23,428
)
$
(19,499
)
$
(73,536
)
$
(79,938
)
Basic and diluted net loss per common
share
$
(0.10
)
$
(0.10
)
$
(0.33
)
$
(0.43
)
Basic and diluted weighted-average shares
outstanding
236,519,812
197,223,419
220,250,060
183,804,257
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201109006020/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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