SAN CLEMENTE, Calif.,
Nov. 14, 2017 /PRNewswire/
-- ReShape Lifesciences Inc. (NASDAQ:RSLS), a developer of
minimally invasive medical devices to treat obesity and metabolic
diseases, today reported financial results for the three months
ended September 30,
2017.
Recent Highlights and Accomplishments
- Acquired ReShape Medical, a privately-held medical technology
company that develops, manufactures and markets the ReShape®
Dual Weight Loss Balloon, in a cash and stock transaction valued at
approximately $61 million
- Announced its plans to relocate its corporate headquarters to
ReShape Medical's offices in San
Clemente, CA and the company name change to ReShape
Lifesciences to better reflect the long-term mission and vision of
the Company
- Completed a $20.0 million
underwritten public offering with net proceeds of $18.0 million in August
- Made significant progress on the clinical front including
obtaining approval from the MHSSE in Spain in August to initiate clinical trials
for the Gastric Vest to support the Company's plans for CE Mark
approval, the announcement of a published cost effectiveness study
analyzing vBloc® in August, and the initiation of the US FDA
post-approval ReNEW study on vBloc in September
- Presented positive commercial data at industry conferences IFSO
in August and ObesityWeek in November
"It has been a busy and productive quarter for us at ReShape
Lifesciences, and I could not be prouder of the accomplishments of
our team, who have proven their ability to execute on our plans."
said Dan Gladney, President, Chief
Executive Officer and Chairman of the Board. "The strategic leaps
we have made combined with our operational progress have paved the
way for ReShape Lifesciences as a leading provider of technologies
to address the needs of patients across the continuum of care in
obesity."
Third Quarter 2017 Financial Results
For the three months ended September 30,
2017, the Company placed 30 units, primarily from the vBloc
Now program, a 36% increase compared to 22 units in the third
quarter of 2016. The Company reported revenues of
$360,000 with gross profit totaling
$146,000 in the third quarter ended
September 30, 2017.
For the nine months ended September 30,
2017, the Company placed 80 units, primarily from the vBloc
Now program, a 57% increase compared to 51 units for the same
period in 2016. For the nine months ended September 30, 2017 the Company reported revenues
of $493,000 with gross profit
totaling $195,000.
As of September 30, 2017, the
Company had cash and cash equivalents totaling $23.4 million and it had no debt.
Conference Call
Management will host an investment community conference call
today beginning at 1:30 p.m. Pacific
Time /4:30 p.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: 5595459.
To listen to a live webcast or a replay, please visit the investor
relations section of the Company website at:
http://ir.enteromedics.com.
About ReShape Lifesciences Inc.
ReShape Lifesciences is a medical device company focused on
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 with a
35-45 Body Mass Index (BMI) feel full, eat less and lose weight by
intermittently blocking hunger signals on the vagus nerve. The
FDA-approved ReShape® Integrated Dual Balloon
System involves a non-surgical weight loss procedure that uses
advanced interconnected balloon technology designed to take up room
in the stomach to help people with a 30-40 BMI, and at least one
co-morbidity, lose weight. The Gastric Vest™ System is an
investigational, minimally invasive, laparoscopically implanted
medical device that wraps around the stomach, emulating the gastric
volume reduction effect of conventional weight-loss surgery, and is
intended to enable rapid weight loss in obese and morbidly obese
patients 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 plans to obtain CE Mark
approval for the Gastric Vest System and our goal of becoming a
leading provider of technologies to address the needs of patients
across 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:
risks and uncertainties related to our acquisition of ReShape
Medical, Inc., including unexpected costs or liabilities, the
ability to recognize the benefits of the acquisition and that the
acquisition may involve unexpected costs or liabilities; 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, particularly
those factors identified as "risk factors" in Exhibit 99.3 of our
current report on Form 8-K filed 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.
RESHAPE
LIFESCIENCES INC.
|
Consolidated
Statements of Operations (unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September
30,
|
|
|
Nine Months Ended
September
30,
|
|
|
2017
|
|
2016
|
|
|
2017
|
|
2016
|
|
|
|
|
|
|
|
|
|
|
Sales
revenue
|
$
|
110,020
|
$
|
296,760
|
|
$
|
243,120
|
$
|
644,760
|
Service
revenue
|
|
250,000
|
|
-
|
|
|
250,000
|
|
-
|
Total
revenue
|
|
360,020
|
|
296,760
|
|
|
493,120
|
|
644,760
|
Cost of
revenue
|
|
214,511
|
|
146,631
|
|
|
298,506
|
|
342,070
|
|
|
Gross
profit
|
|
145,509
|
|
150,129
|
|
|
194,614
|
|
302,690
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative
|
|
4,595,538
|
|
3,361,572
|
|
|
16,085,311
|
|
15,088,297
|
|
Research and
development
|
|
1,109,641
|
|
1,253,390
|
|
|
3,586,129
|
|
3,879,378
|
|
|
Total operating
expenses
|
|
5,705,179
|
|
4,614,962
|
|
|
19,671,440
|
|
18,967,675
|
|
|
Operating
loss
|
|
(5,559,670)
|
|
(4,464,833)
|
|
|
(19,476,826)
|
|
(18,664,985)
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
-
|
|
1,493
|
|
|
100
|
|
4,991
|
|
Interest
expense
|
|
-
|
|
(1,391,134)
|
|
|
-
|
|
(3,393,374)
|
|
Warrants
expense
|
|
(4,438,149)
|
|
-
|
|
|
(4,438,149)
|
|
-
|
|
Change in value of
warrant liability
|
|
5,047
|
|
241,741
|
|
|
(283,688)
|
|
3,330,254
|
|
Change in value of
convertible notes payable
|
|
-
|
|
(909,030)
|
|
|
-
|
|
(200,004)
|
|
Other, net
|
|
(904)
|
|
(700)
|
|
|
(2,102)
|
|
(3,272)
|
|
|
Net loss
|
$
|
(9,993,676)
|
$
|
(6,522,463)
|
|
$
|
(24,200,665)
|
$
|
(18,926,390)
|
|
|
|
|
|
|
|
|
|
|
Net loss per share -
basic and diluted
|
$
|
(1.06)
|
$
|
(11.77)
|
|
$
|
(3.19)
|
$
|
(69.14)
|
|
|
|
|
|
|
|
|
|
|
Shares used to
compute basic and diluted net loss
per share
|
|
|
|
|
|
|
|
|
|
|
9,470,807
|
|
554,028
|
|
|
7,589,239
|
|
273,751
|
RESHAPE
LIFESCIENCES INC.
|
Condensed
Consolidated Balance Sheets (unaudited)
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
September
30,
|
|
December
31,
|
|
|
2017
|
|
2016
|
ASSETS
|
Cash, cash
equivalents and short-term investments
|
$
|
23,433
|
$
|
3,311
|
Accounts
receivable
|
|
333
|
|
144
|
Inventory
|
|
1,587
|
|
1,790
|
Prepaid expenses and
other current assets
|
|
252
|
|
476
|
Property and
equipment, net
|
|
196
|
|
201
|
Goodwill
|
|
6,398
|
|
-
|
Intangibles,
net
|
|
21,842
|
|
-
|
Other
assets
|
|
1,142
|
|
1,119
|
|
|
Total
assets
|
$
|
55,183
|
$
|
7,041
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
Liabilities:
|
|
|
|
|
|
Accounts
payable
|
$
|
707
|
$
|
1,312
|
|
Debt
|
|
-
|
|
-
|
|
Other
liabilities
|
|
3,429
|
|
2,790
|
|
|
Total
liabilities
|
|
4,136
|
|
4,102
|
Stockholders'
equity
|
|
51,047
|
|
2,939
|
|
|
Total liabilities and
stockholders' equity
|
$
|
55,183
|
$
|
7,041
|
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SOURCE ReShape Lifesciences Inc.