ST. PAUL, Minn., Aug. 8, 2017 /PRNewswire/ -- EnteroMedics
Inc. (NASDAQ:ETRM), a developer of minimally invasive medical
devices to treat obesity, metabolic diseases and other
gastrointestinal disorders, today reported financial results for
the three months ended June 30,
2017.
Recent Highlights and Accomplishments
- Placed a record 42 vBloc commercial units in the second quarter
of 2017, up 83% from a year ago. 34 of these placements were part
of the Company's recently-launched vBloc Now program
- Launched vBloc Now reduced-cost program with the goal to
expedite reimbursement by increasing commercial real-world implants
and patient outcomes data for payers
- Announced the acquisition of BarioSurg, Inc. and its minimally
invasive Gastric Vest System, and subsequently last week received
approval from the MHSSE in Spain
to start the Spanish portion of CE Mark study for the Gastric Vest
System
- Initiated Kaiser type 2 diabetes trial to study vBloc compared
to standard of care treatment for type 2 diabetes
- Entered into a collaboration agreement under which EnteroMedics
will modify its vBloc System for use in pre-clinical research by a
corporate partner
- Completed first covered vBloc implant for a veteran through the
VA Choice Program
"I am incredibly proud of what we have accomplished at
EnteroMedics in these past few months," said Dan Gladney, President, Chief Executive Officer
and Chairman of the Board at EnteroMedics. "The programs we have
put into place combined with the strategic and operational progress
at the Company position EnteroMedics to become a premier provider
of products to address the continuum of care in obesity."
Second Quarter 2017 Financial Results
For the three months ended June 30,
2017, the Company placed 42 units, primarily from the vBloc
Now program, an 83% increase compared to 23 units in the second
quarter of 2016. The Company reported sales of
$93,000 with gross profit totaling
$39,000 in the second quarter ended
June 30, 2017.
For the six months ended June 30,
2017, the Company placed 50 units, primarily from the vBloc
Now program, a 72% increase compared to 29 units for the same
period in 2016. For the six months ended June 30, 2017 the Company reported sales of
$133,000 with gross profit totaling
$49,000.
As of June 30, 2017, the Company
had cash, cash equivalents and short-term investments totaling
$11.2 million and it had no debt.
Conference Call
Management will host an investment community conference call
today beginning at 10:30 a.m. Central
Time / 11:30 a.m. Eastern
Time
Individuals interested in listening to the conference call may
do so by dialing (877) 280-7473 for domestic callers or (707)
287-9370 for international callers, using Conference ID: 64730754.
To listen to a live webcast or a replay, please visit the investor
relations section of the EnteroMedics website at:
http://ir.enteromedics.com.
About EnteroMedics Inc.
EnteroMedics is a medical device company focused on the
development and commercialization of technology to treat obesity
and metabolic diseases. vBloc® Neurometabolic Therapy, delivered by
an FDA-approved pacemaker-like device called the vBloc® System, is
designed to help patients feel full and eat less by intermittently
blocking hunger signals on the vagus nerve. EnteroMedics recently
acquired the Gastric Vest System™ through its acquisition of
BarioSurg, Inc. The Gastric Vest is an investigational, minimally
invasive, laparoscopically implanted medical device being studied
for weight loss in morbidly obese patients. The device wraps around
the stomach, emulating the effect of conventional weight-loss
surgery, and is intended to enable gastric volume reduction without
permanently changing patient anatomy.
Forward-Looking Safe Harbor Statement:
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. These forward-looking statements generally can be identified
by the use of words such as expect," "plan," "anticipate," "could,"
"may," "intend," "will," "continue," "future," other words of
similar meaning and the use of future dates. Forward-looking
statements in this release include our goal of positioning
EnteroMedics to become a premier provider of products to address
the continuum of care in obesity.. These forward-looking statements
are based on the current expectations of our management and involve
known and unknown risks and uncertainties that may cause our actual
results, performance or achievements to be materially different
from any future results, performance or achievements expressed or
implied by the forward-looking statements. Such risks and
uncertainties include, among others: our limited history of
operations; our losses since inception and for the foreseeable
future; our limited commercial sales experience with our vBloc®
System for the treatment of obesity in the United States or in any foreign market
other than Australia and the
European Community; the competitive industry in which we operate;
our ability to maintain compliance with the Nasdaq continued
listing requirements; our ability to commercialize our vBloc®
System; our dependence on third parties to initiate and perform our
clinical trials; the need to obtain regulatory approval for any
modifications to our vBloc® System; physician adoption of our
vBloc® System and vBloc® Neurometabolic Therapy; our ability to
obtain third party coding, coverage or payment levels; ongoing
regulatory compliance; our dependence on third party manufacturers
and suppliers; the successful development of our sales and
marketing capabilities; our ability to raise additional capital
when needed; international commercialization and operation; our
ability to attract and retain management and other personnel and to
manage our growth effectively; potential product liability claims;
the cost and management time of operating a public company;
potential healthcare fraud and abuse claims; healthcare legislative
reform; and our ability to obtain and maintain intellectual
property protection for our technology and products. These and
additional risks and uncertainties are described more fully in the
Company's filings with the Securities and Exchange Commission,
including those factors identified as "risk factors" in the Exhibit
99.3 of our Current Report on Form 8-K filed on July 26, 2017. We are providing this information
as of the date of this press release and do not undertake any
obligation to update any forward-looking statements contained in
this document as a result of new information, future events or
otherwise.
ENTEROMEDICS
INC.
|
Consolidated
Statements of Operations (unaudited)
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Three Months Ended
June 30,
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Six Months Ended
June 30,
|
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2017
|
|
2016
|
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2017
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2016
|
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Sales
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|
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|
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$
|
93,060
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$
|
276,000
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|
133,100
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$
|
348,000
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Cost of goods
sold
|
|
54,472
|
|
155,304
|
|
83,995
|
|
195,439
|
|
|
|
|
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Gross
profit
|
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38,588
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|
120,696
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|
49,105
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|
152,561
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Operating
expenses:
|
|
|
|
|
|
|
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Selling, general and
administrative
|
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5,560,787
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|
5,585,548
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11,489,773
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|
11,726,725
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|
Research and
development
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1,352,075
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|
1,193,607
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|
2,476,488
|
|
2,625,988
|
|
|
|
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|
Total operating
expenses
|
|
6,912,862
|
|
6,779,155
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|
13,966,261
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|
14,352,713
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|
|
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Operating
loss
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(6,874,274)
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(6,658,459)
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(13,917,156)
|
|
(14,200,152)
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Other income
(expense):
|
|
|
|
|
|
|
|
|
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Interest
income
|
|
-
|
|
1,807
|
|
100
|
|
3,498
|
|
Interest
expense
|
|
-
|
|
(852,946)
|
|
-
|
|
(2,002,240)
|
|
Change in value of
warrant liability
|
|
34,395
|
|
1,309,099
|
|
(288,735)
|
|
3,088,513
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|
Change in value of
convertible notes payable
|
|
-
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|
1,208,594
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|
-
|
|
709,026
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Other, net
|
|
|
|
(298)
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|
(3,260)
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|
(1,198)
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|
(2,572)
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|
|
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Net loss
|
$
|
(6,840,177)
|
$
|
(4,995,165)
|
|
(14,206,989)
|
$
|
(12,403,927)
|
|
|
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|
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Net loss per share -
basic and diluted
|
$
|
(0.91)
|
$
|
(33.96)
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|
(2.14)
|
$
|
(95.64)
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Shares used to
compute basic and
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diluted net loss per
share
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7,501,696
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147,108
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6,632,862
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129,698
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ENTEROMEDICS
INC.
|
Condensed
Consolidated Balance Sheets (unaudited)
|
(in
thousands)
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June
30,
|
|
December
31,
|
|
|
|
|
|
|
|
|
2017
|
|
2016
|
ASSETS
|
Cash, cash
equivalents and short-term investments
|
$
|
11,198
|
$
|
3,311
|
Accounts
receivable
|
|
109
|
|
144
|
Inventory
|
|
|
|
|
1,417
|
|
1,790
|
Prepaid expenses and
other current assets
|
|
537
|
|
476
|
Property and
equipment, net
|
|
241
|
|
201
|
Goodwill
|
|
|
|
|
6,398
|
|
-
|
Intangibles,
net
|
|
|
21,886
|
|
-
|
Other
assets
|
|
|
|
734
|
|
1,119
|
|
|
|
|
Total
assets
|
$
|
42,520
|
$
|
7,041
|
|
|
|
|
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LIABILITIES AND
STOCKHOLDERS' EQUITY
|
Liabilities:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
$
|
1,109
|
$
|
1,312
|
|
Debt
|
|
|
|
|
-
|
|
-
|
|
Other
liabilities
|
|
3,406
|
|
2,790
|
|
|
|
|
Total
liabilities
|
|
4,515
|
|
4,102
|
Stockholders'
equity
|
|
38,005
|
|
2,939
|
|
|
|
|
Total liabilities and
stockholders' equity
|
$
|
42,520
|
$
|
7,041
|
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SOURCE EnteroMedics Inc.