ReShape Lifesciences Inc. (Nasdaq:
RSLS), the premier physician-led weight loss and metabolic
health-solutions company, today reported financial results for the
first quarter ended March 31, 2023 and provided a corporate
strategic update.
First Quarter 2023 and Subsequent
Highlights
- In May, presented preclinical data
on its proprietary Diabetes Bloc-Stim Neuromodulation™ (DBSN™)
device in a poster at the Keystone Symposia on Type 2 Diabetes
(T2D) in Palm Springs, CA, further validating the potential of this
technology to treat T2D and reduce patients’ dependence on
medication.
- In April, completed a $2.5 million
registered direct offering with a single institutional investor,
extending the company's cash runway into 2024, creating a
sustainable path to profitability.
- In April, received a Notice of
Allowance from the U.S. Patent and Trademark Office (USPTO) for
patent application 16/792,094, entitled, “Systems and Methods for
Determining Failure of Intragastric Devices,” related to the
company’s Obalon® Balloon System, expected to provide protection
into at least January 2031, excluding any potential Patent Term
Extension (PTE).
- In March, formed a Scientific
Advisory Board (SAB) comprised of internationally recognized
experts and surgeons in the obesity and metabolic disease fields.
The newly created SAB will provide management with strategic input
and external scientific review of the company’s development
activities and product pipeline.
- In February, raised $10.2 million
in an upsized underwritten public offering.
“In 2023, we have continued to leverage
operational efficiencies, optimize our lead generation programs,
and invest in our growth drivers. Our achievement of a 42.9%
reduction in operating expenses, excluding one-time charges, during
the first quarter, as compared to the same period last year, is a
direct result of the execution of our growth pillars. We will
continue to drive revenue by expanding our product offering to
treat obesity and metabolic disease across the entire care
continuum and strengthen our position to exceed our goals,” stated
Paul F. Hickey, President and Chief Executive Officer of ReShape
Lifesciences®. “We remain focused, not only on growth, but also our
future profitability and delivering predictable shareholder value.
Our balance sheet was bolstered by two capital raises this year,
totaling $12.7 million in gross proceeds. These funds will allow us
the continued ability to generate awareness of our evidence-based
and differentiated product portfolio that spans the entire care
continuum.”
“Additionally, I am particularly enthusiastic
about working with our recently formed, global SAB, whose members
will provide invaluable insights on our market, our key strategic
initiatives including our now fully launched ReShape Calibration
Tubes and our Lap-Band® 2.0 System, which we expect to submit to
the U.S. Food and Drug Administration (FDA) in the next few weeks
for PMA Supplement approval. We expect feedback from the FDA by
year end. If approved, we expect adoption of the Lap-Band® 2.0 to
be widespread among existing and new Lap-Band surgeons, alike.
At the same time, we continue to engage
healthcare professionals, employers and individuals to expand
awareness and use of ReShape’s personalized HIPAA-compliant, weight
management program, ReShapeCare™, with resources including
personalized health coaching that helps individuals achieve durable
long-term weight loss goals, improvements in obesity related
comorbidities and quality of life. Of note, we remain committed to
working with large, self-insured employers to provide ReShapeCare™
to their employees in order to positively impact overall employee
health and, thus, reduce employers’ health care costs.”
Mr. Hickey concluded, “Today, medical weight
loss is gaining historic levels of awareness and ReShape’s Lap-Band
system is well positioned as a long-term weight loss solution that
is non-pharmacological, minimally invasive, adjustable and broadly
reimbursed. I am more enthusiastic about the future of ReShape than
ever before, as we continued to execute on our growth pillars to
solidify our position as the premier physician-led weight loss and
metabolic health-solutions company.”
Tom Stankovich, Chief Financial Officer of
ReShape Lifesciences®, added, “The significant 42.9% reduction in
operating expenses achieved in the first quarter of 2023, compared
to the same period in 2022, before one-time charges, were
consistent across all expense categories and is evidence of our
strategic focus on achieving greater operating efficiencies. These
reductions, combined with our expectation for increased revenue
resulting from our targeted digital media campaign focused on
geographies near bariatric surgery centers that sell the Lap-Band®
system, and the recently launched and re-designed ReShape
Calibration Tubes, are expected to positively impact revenue for
the remainder of 2023 and move ReShape closer to cash flow
breakeven.”
First Quarter Ended March 31, 2023,
Financial and Operating Results
Revenue totaled $2.3 million
for the three months ended March 31, 2023, which represents a
contraction of 6.3%, or $0.2 million compared to the same period in
2022. The primary reason for the decrease is a decrease in sales
throughout Europe. During the three months ended March 31, 2023,
the company placed more focus on domestic sales, resulting in lower
international sales. The company’s expectation is that revenue will
continue to increase through the remainder of 2023, as the company
is focusing on a targeted digital media campaign near bariatric
surgical centers that sell the Lap-Band® system and have fully
launched the three new sizes of calibration tubes.
Gross Profit for both the three
months ended March 31, 2023, and 2022, was $1.2 million. Gross
profit as a percentage of total revenue for the three months ended
March 31, 2023, was 53.5% compared to 49.9% for the same period in
2022. The increase in gross profit percentage is due to the company
becoming more efficient and looking for cost reductions within the
company’s manufacturing processes.
Sales and Marketing Expenses
for the three months ended March 31, 2023, decreased by $2.5
million, or 53.5%, to $2.2 million, compared to $4.7 million for
the same period in 2022. The decrease is primarily due to a
decrease of $2.4 million in advertising and marketing expenses, as
the company has reevaluated its marketing approach and has moved to
a targeted digital marketing campaign, resulting in a reduction of
costs. The company also had a reduction in payroll expenditure,
including commissions of $0.2 million, due to changes in sales
personnel and lower sales. There was also a reduction in
stock-based compensation expenses of $0.1 million. This was offset
by an increase in consulting and professional services of $0.2
million, as the company is working on developing the ReShapeCare™
platform.
General and Administrative
Expenses for the three months ended March 31, 2023,
increase by $0.3 million, or 8.4%, to $4.2 million, compared to
$3.9 million for the same period in 2022. The increase is due to
one-time adjustments for professional services of $1.7 million
primarily related to the February public offering. This was offset
by a decrease of $0.4 million in stock-based compensation expense
and $0.4 million in payroll related expenditure due to changes in
personnel. Additionally, we had a decrease in amortization cost of
$0.4 million as we impaired our finite lived intangible assets
during the fourth quarter of 2022. We also had a decrease in rent
of $0.1 million as the lease in Carlsbad, California terminated
during June 2022. We had many miscellaneous reductions in general
and administrative expenses, as we are continuously working on
efficiencies and cost reduction efforts.
Research and Development
Expenses for the three months ended March 31, 2023,
decreased by $0.3 million, or 39.2%, to $0.5 million, compared to
$0.8 million for the same period in 2022. The decrease is primarily
due to a reduction of $0.2 million in payroll expenses and a
reduction of $0.1 million in consulting and clinical related
expenses.
Cash and Cash Equivalents as of
March 31, 2023, were $9.1 million and the company remains debt free
on its balance sheet, which the company believes is sufficient to
fund current operations into 2024.
A full discussion of our financials is available
in our Annual Report on Form 10-Q, filed with the Securities and
Exchange Commission.
Conference Call Information
Management will host a conference call to
discuss ReShape’s financial and
operational results today at 4:30 pm ET. To
participate in the conference call please register with the
following Registration Link, and dial-in details will be provided.
Participants using this feature are requested to dial into the
conference call fifteen minutes ahead of time to avoid delays.
An archived replay will also be available on the
“Events and Presentations” section of ReShape’s website at:
https://ir.reshapelifesciences.com/events-and-presentations.
About ReShape Lifesciences®
ReShape Lifesciences® is America’s premier weight loss and
metabolic health-solutions company, offering an integrated
portfolio of proven products and services that manage and treat
obesity and metabolic disease. The FDA-approved Lap-Band® System
provides minimally invasive, long-term treatment of obesity and is
an alternative to more invasive surgical stapling procedures such
as the gastric bypass or sleeve gastrectomy. ReShapeCare™ is a
virtual weight-management program that supports lifestyle changes
for all weight loss patients led by board-certified health coaches
to help them keep the weight off over time. The recently launched
ReShape Marketplace™ is an online collection of quality wellness
products curated for all consumers to help them achieve their
health goals. The investigational Diabetes Bloc-Stim
Neuromodulation™ (DBSN™) system utilizes a proprietary vagus nerve
block and stimulation technology platform for the treatment of type
2 diabetes and metabolic disorders. The Obalon® balloon technology
is a non-surgical, swallowable, gas-filled intra-gastric balloon
that is designed to provide long-lasting weight loss. For more
information, please visit www.reshapelifesciences.com.
Forward-Looking Safe Harbor
Statement This press release may contain forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Actual results could differ materially from
those discussed due to known and unknown risks, uncertainties, and
other factors. 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 press release include
statements about the Company’s expected path to profitability, the
expected timing of the FDA submission and review process for the
Lap-Band 2.0, the expected adoption of the Lap-Band 2.0 by
surgeons, and the expectation for increased revenue. 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 our most
recent Annual Report on Form 10-K and subsequent Quarterly Reports
on Form 10-Q. 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, except as
required by law.
Non-GAAP DisclosuresIn addition
to the financial information prepared in conformity with GAAP, we
provide certain historical non-GAAP financial information.
Management believes that these non-GAAP financial measures assist
investors in making comparisons of period-to-period operating
results.
Management believes that the presentation of
this non-GAAP financial information provides investors with greater
transparency and facilitates comparison of operating results across
a broad spectrum of companies with varying capital structures,
compensation strategies, and amortization methods, which provides a
more complete understanding of our financial performance,
competitive position, and prospects for the future. However, the
non-GAAP financial measures presented in this release have certain
limitations in that they do not reflect all of the costs associated
with the operations of our business as determined in accordance
with GAAP. Therefore, investors should consider non-GAAP financial
measures in addition to, and not as a substitute for, or as
superior to, measures of financial performance prepared in
accordance with GAAP. Further, the non-GAAP financial measures
presented by the company may be different from similarly named
non-GAAP financial measures used by other companies.
Adjusted EBITDAManagement uses
Adjusted EBITDA in its evaluation of the company’s core results of
operations and trends between fiscal periods and believes that
these measures are important components of its internal performance
measurement process. Adjusted EBITDA is defined as net loss before
interest, taxes, depreciation and amortization, stock-based
compensation, and other one-time costs. Management uses Adjusted
EBITDA in its evaluation of the company’s core results of
operations and trends between fiscal periods and believes that
these measures are important components of its internal performance
measurement process. Therefore, investors should consider non-GAAP
financial measures in addition to, and not as a substitute for, or
as superior to, measures of financial performance prepared in
accordance with GAAP. Further, the non-GAAP financial measures
presented by the company may be different from similarly named
non-GAAP financial measures used by other companies.
CONTACTSReShape Lifesciences Investor
Contact:Thomas StankovichChief Financial
Officer949-276-6042ir@ReShapeLifesci.com
Investor Relations Contact:Rx
Communications GroupMichael
Miller(917)-633-6086mmiller@rxir.com
|
RESHAPE LIFESCIENCES INC.Consolidated
Balance Sheets (dollars in thousands; unaudited) |
|
|
|
March 31, |
|
December 31, |
|
|
2023 |
|
|
2022 |
|
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
8,983 |
|
|
$ |
3,855 |
|
Restricted cash |
|
|
100 |
|
|
|
100 |
|
Accounts and other receivables |
|
|
2,125 |
|
|
|
2,180 |
|
Inventory |
|
|
3,493 |
|
|
|
3,611 |
|
Prepaid expenses and other current assets |
|
|
530 |
|
|
|
165 |
|
Total current assets |
|
|
15,231 |
|
|
|
9,911 |
|
Property and equipment,
net |
|
|
672 |
|
|
|
698 |
|
Operating lease right-of-use
assets |
|
|
86 |
|
|
|
171 |
|
Deferred tax asset, net |
|
|
57 |
|
|
|
56 |
|
Other intangible assets,
net |
|
|
249 |
|
|
|
260 |
|
Other assets |
|
|
57 |
|
|
|
46 |
|
Total assets |
|
$ |
16,352 |
|
|
$ |
11,142 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,997 |
|
|
$ |
1,926 |
|
Accrued and other liabilities |
|
|
5,319 |
|
|
|
5,040 |
|
Warranty liability, current |
|
|
200 |
|
|
|
344 |
|
Operating lease liabilities, current |
|
|
86 |
|
|
|
171 |
|
Total current liabilities |
|
|
7,602 |
|
|
|
7,481 |
|
Common stock
warrant liability |
|
|
992 |
|
|
|
— |
|
Total liabilities |
|
|
8,594 |
|
|
|
7,481 |
|
Commitments and
contingencies |
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
Preferred stock |
|
|
|
|
|
|
Series C convertible preferred stock |
|
|
— |
|
|
|
— |
|
Common stock |
|
|
3 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
634,697 |
|
|
|
627,935 |
|
Accumulated deficit |
|
|
(626,849 |
) |
|
|
(624,187 |
) |
Accumulated other comprehensive loss |
|
|
(93 |
) |
|
|
(88 |
) |
Total stockholders’ equity |
|
|
7,758 |
|
|
|
3,661 |
|
Total liabilities and stockholders’ equity |
|
$ |
16,352 |
|
|
$ |
11,142 |
|
|
RESHAPE LIFESCIENCES INC. Consolidated
Statements of Operations (dollars in thousands;
unaudited) |
|
|
|
|
Three Months Ended March 31, |
|
|
|
2023 |
|
|
2022 |
|
Revenue |
|
|
$ |
2,287 |
|
|
$ |
2,440 |
|
Cost of revenue |
|
|
|
1,063 |
|
|
|
1,222 |
|
Gross profit |
|
|
|
1,224 |
|
|
|
1,218 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Sales and marketing |
|
|
|
2,182 |
|
|
|
4,694 |
|
General and administrative |
|
|
|
4,220 |
|
|
|
3,892 |
|
Research and development |
|
|
|
453 |
|
|
|
745 |
|
Total operating expenses |
|
|
|
6,855 |
|
|
|
9,331 |
|
Operating loss |
|
|
|
(5,631 |
) |
|
|
(8,113 |
) |
Other expense
(income), net: |
|
|
|
|
|
|
|
Interest expense, net |
|
|
|
5 |
|
|
|
(1 |
) |
Gain on changes in fair value of liability warrants |
|
|
|
(2,965 |
) |
|
|
— |
|
Gain on foreign currency exchange, net |
|
|
|
(21 |
) |
|
|
(16 |
) |
Other |
|
|
|
(2 |
) |
|
|
(11 |
) |
Loss before income tax
provision |
|
|
|
(2,648 |
) |
|
|
(8,085 |
) |
Income tax benefit |
|
|
|
14 |
|
|
|
30 |
|
Net loss |
|
|
$ |
(2,662 |
) |
|
$ |
(8,115 |
) |
The following table contains a reconciliation of GAAP net loss
to non-GAAP net loss Adjusted EBITDA attributable to common
stockholders for the months ended March 31, 2023 and 2022 (in
thousands):
|
Three Months Ended March 31, |
|
2023 |
|
|
2022 |
|
GAAP net loss |
$ |
(2,662 |
) |
|
$ |
(8,115 |
) |
Adjustments: |
|
|
|
|
|
Interest expense, net |
|
5 |
|
|
|
(1 |
) |
Income tax benefit |
|
14 |
|
|
|
30 |
|
Depreciation and amortization |
|
48 |
|
|
|
550 |
|
Stock-based compensation expense |
|
222 |
|
|
|
719 |
|
Gain on changes in fair value of liability warrants |
|
(2,965 |
) |
|
|
— |
|
Adjusted EBITDA |
$ |
(5,338 |
) |
|
$ |
(6,817 |
) |
ReShape Lifesciences (NASDAQ:RSLS)
과거 데이터 주식 차트
부터 6월(6) 2024 으로 7월(7) 2024
ReShape Lifesciences (NASDAQ:RSLS)
과거 데이터 주식 차트
부터 7월(7) 2023 으로 7월(7) 2024