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, 2025 and provided a corporate
strategic update.
First Quarter 2025 and Subsequent
Highlights
- May 2025: Effected a 1-for-25
reverse stock split of the company’s common stock, which was
effective for trading purposes upon the commencement of trading on
May 9, 2025.
- May 2025: Presented pre-clinical
data on its proprietary Diabetes Neuromodulation device in a poster
presentation at the 12th Annual Minnesota Neuromodulation
Symposium. Jonathan J. Waataja, Ph.D., Director of Research at
ReShape Lifesciences®, presented the data in a poster presentation
entitled, Stimulation of the Posterior Sub-Diaphragmatic Vagal
Trunk Reverses Insulin-Induced Severe Hypoglycemia in a Swine Model
of Type 1 Diabetes Mellitus.
- April 2025: Received a Notice of
Allowance from the U.S. Patent and Trademark Office (USPTO) for
patent application 18/241,151, entitled, “Intragastric Device.”
When issued, the patent will cover claims for an intragastric
balloon system, comprising a swallowable capsule with a
self-sealing fill valve and a degradable release valve designed to
deflate and open the valve around three months after inflation with
saline liquid, and configured for natural excretion after
deflation, among other claim features. Once issued, the patent will
provide protection into at least January 2031, without accounting
for a potential Patent Term Extension (PTE).
- April 2025: Received a Notice of
Allowance from the USPTO for patent application 18/069,689,
entitled, “High-Frequency Low Duty Cycle Patterns for Neural
Regulation.” When issued, the patent will provide protection until
August 4, 2037. The Diabetes Neuromodulation system leverages its
proprietary vagus nerve block (vBloc™) technology platform, along
with vagus nerve stimulation, to treat Type 2 diabetes, a prominent
disorder linked with obesity.
- April 2025: Announced an agreement
with Haifa, Israel-based Motion Informatics to exclusively import
and distribute their next-generation neuromuscular rehabilitation
devices in the U.S. The flagship product, the Stimel-03, was
showcased at the American Occupational Therapy Association 2025
Annual Conference and Expo, held April 3-5, 2025, in Philadelphia,
PA.
- March 2025: Received a Notice of
Allowance from the USPTO for patent application 17/046,677,
entitled, “Simultaneous Multi-Site Vagus Nerve Modulation for
Improved Glycemic Control System and Methods.” When issued, the
patent will provide protection until April 12, 2039.
- February 2025: Signed a
distribution agreement with Liaison Medical for ReShape’s next
generation, enhanced Lap-Band® 2.0 FLEX and Tubing Kit, in
Canada.
- February 2025: Closed an upsized
$6.0 million public offering.
- February 2025: Granted a key
international patent from the State of Israel Patent Office for the
company’s Diabetes Neuromodulation technology. Patent Number
277949, entitled, “Simultaneous Multi-Site Vagus Nerve Modulation
for Improved Glycemic Control Systems and Methods,” will provide
protection until December 4, 2039.
- January 2025: Provided an update on
the definitive merger agreement under which ReShape and Vyome will
combine in an all-stock transaction. The combined company will
focus on advancing the development of Vyome’s immuno-inflammatory
assets and on identifying additional opportunities between the
world-class Indian innovation corridor and the U.S. market. ReShape
also provided an update on the asset purchase agreement with Biorad
Medisys.
On July 8, 2024, ReShape Lifesciences Inc.
entered into a definitive merger agreement with Vyome, under which
ReShape and Vyome will combine in an all-stock transaction. At the
closing of the merger, ReShape will be renamed Vyome Holdings, Inc.
and expects to trade under the Nasdaq ticker symbol "HIND,"
representing the company’s alignment with the U.S.-India
relationship. The board of directors of the combined company will
be comprised of six directors designated by Vyome and one director
designated by ReShape, and executive management of the combined
company will consist of Vyome’s executive officers.
Simultaneously with the execution of the merger
agreement, ReShape entered into an asset purchase agreement with
Biorad, which was amended on April 25, 2025, which is party to a
previously disclosed exclusive license agreement with ReShape for
ReShape’s Obalon® Gastric Balloon System. Pursuant to the asset
purchase agreement, ReShape will sell substantially all of its
assets to Biorad (or an affiliate thereof), including ReShape’s
Lap-Band® System, Obalon® Gastric Balloon System and the Diabetes
Bloc-Stim Neuromodulation™ (DBSN™) System (but excluding cash), and
Biorad will assume substantially all of ReShape’s liabilities. The
cash purchase price under the asset purchase agreement will count
toward ReShape’s net cash for purposes of determining the
post-merger ownership allocation between ReShape and Vyome
stockholders under the merger agreement.
"The first quarter of 2025 and the months that
followed have marked a period of strong momentum for ReShape, both
operationally and strategically,” stated Paul F. Hickey, President
and Chief Executive Officer of ReShape Lifesciences®. “We continued
to expand access to our portfolio of physician-led, minimally
invasive weight-loss solutions, highlighted by a new distribution
agreement with Liaison Medical to launch our enhanced Lap-Band® 2.0
FLEX to the Canadian market. This partnership, following our Health
Canada approval in late 2024, is a significant milestone in
delivering effective, less-invasive alternatives to bariatric
surgery to broader global patient base. We also expanded our
product portfolio through an exclusive U.S. distribution agreement
for Motion Informatics’ next-generation neuromuscular
rehabilitation devices, further broadening our portfolio of
innovative medical devices.
“At the same time, we strengthened our
leadership in diabetes innovation by presenting promising
pre-clinical data on our Diabetes Neuromodulation device at the
12th Annual Minnesota Neuromodulation Symposium, in a featured
poster presentation, showcasing the potential of our proprietary
vagus neuromodulation technology platform. Further strengthening
our position, the Diabetes Neuromodulation system received
significant intellectual property protection, including multiple
Notices of Allowance from the USPTO and a pivotal international
patent from the Israel Patent Office. These patents extend our
intellectual property coverage through at least 2039, underscoring
our leadership in addressing both Type 1 and Type 2 diabetes
through neuromodulation and its close association with obesity. We
also received a Notice of Allowance for our intragastric device
patent, which covers a next-generation, self-deflating, swallowable
balloon system—an important addition to our metabolic health
platform. As our patent portfolio grows, we remain committed to
protecting our position and, when appropriate, will pursue
strategic, non-dilutive funding to support this objective.”
Mr. Hickey concluded, “The successful completion
of our $6.0 million public offering in February strengthens our
financial foundation as we continue to execute on our growth
initiatives. Finally, we are making continued progress toward
finalizing our merger with Vyome and the asset sale to Biorad
Medisys. The S-4 was recently declared effective and we are working
to set the record date in the near future. Our Board unanimously
supports this transformative transaction, which we believe will
unlock long-term value for shareholders and drive accelerated
growth for the newly combined company."
First Quarter Ended March 31, 2025,
Financial and Operating Results
Revenue $1.1 million for the
three months ended March 31, 2025, which represents a contraction
of 42.7%, or $0.8 million compared to the same period in 2024. This
primarily resulted from a decrease in sales volume primarily due to
GLP-1 pharmaceutical weight-loss alternatives as well as a
temporary pause in DTC marketing programs.
Gross Profit for the three
months ended March 31, 2025 and 2024, was $0.7 million, and $1.2
million, respectively. Gross profit as a percentage of total
revenue for the three months ended March 31, 2025, was 61.2%
compared to 59.9% for the same period in 2024. The increase in
gross profit percentage is due to the reduction in overhead related
costs, primarily payroll.
Sales and Marketing Expenses
for the three months ended March 31, 2025, decreased by $0.5
million, or 48.1%, to $0.5 million, compared to $1.0 million for
the same period in 2024. The decrease is primarily due to a
decrease in advertising and marketing expenses, including
consulting and professional marketing services.
General and Administrative
Expenses for the three months ended March 31, 2025,
decreased by approximately $0.3 million, or 13.1%, to $1.6 million,
compared to $1.9 million for the same period in 2024. The decrease
is primarily due to a $0.4 million reduction in general legal,
audit, and other professional fees, as the Company reduced its
reliance on consultants and professional services to conserve
cash.
Research and Development
Expenses for the three months ended March 31, 2025,
decreased by $0.1 million, or 24.8% to $0.4 million, compared to
approximately $0.5 million for the same period in the prior
year.
Transaction Costs for the three months ended
March 31, 2025, were $0.4 million. These expenses primarily
consisted of legal and audit-related fees incurred in connection
with the Company’s pending merger and asset sale.
Gain on changes in fair value of liability
warrants for the three months ended March 31, 2025 of
$3.7 million is related to the change in fair value of
liability-classified warrants issued in connection with the
Company’s February 2025 public offering. The gain recognized in the
quarter reflects the decrease in the fair value of the warrants
between the issuance date and March 31, 2025.
Cash and Cash Equivalents as of
March 31, 2025 were $2.6 million, including restricted cash.
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. The investigational
vagal neuromodulation 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.
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.
Additional Information
In connection with the proposed Merger and Asset
Sale, ReShape plans to file with the Securities and Exchange
Commission (the “SEC”) and mail or otherwise provide to its
stockholders a joint proxy statement/prospectus and other relevant
documents in connection with the proposed Merger and Asset Sale.
Before making a voting decision, ReShape’s stockholders are urged
to read the joint proxy statement/prospectus and any other
documents filed by ReShape with the SEC in connection with the
proposed Merger and Asset Sale or incorporated by reference therein
carefully and in their entirety when they become available because
they will contain important information about ReShape, Vyome and
the proposed transactions. Investors and stockholders may obtain a
free copy of these materials (when they are available) and other
documents filed by ReShape with the SEC at the SEC’s website at
www.sec.gov, at ReShape’s website at www.reshapelifesciences.com,
or by sending a written request to ReShape at 18 Technology Drive,
Suite 110, Irvine, California 92618, Attention: Corporate
Secretary.
Participants in the Solicitation
This document does not constitute a solicitation
of proxy, an offer to purchase or a solicitation of an offer to
sell any securities of ReShape and its directors, executive
officers and certain other members of management and employees may
be deemed to be participants in soliciting proxies from its
stockholders in connection with the proposed Merger and Asset Sale.
Information regarding the persons who may, under the rules of the
SEC, be considered to be participants in the solicitation of
ReShape’s stockholders in connection with the proposed Merger and
Asset Sale will be set forth in joint proxy statement/prospectus if
and when it is filed with the SEC by ReShape and Vyome. Security
holders may obtain information regarding the names, affiliations
and interests of ReShape’s directors and officers in ReShape’s
Annual Report on Form 10-K for the fiscal year ended December 31,
2024, which was filed with the SEC on April 4, 2025. To the extent
the holdings of ReShape securities by ReShape’s directors and
executive officers have changed since the amounts set forth in
ReShape’s proxy statement for its most recent annual meeting of
stockholders, such changes have been or will be reflected on
Statements of Change in Ownership on Form 4 filed with the SEC.
Additional information regarding these individuals and any direct
or indirect interests they may have in the proposed Merger and
Asset Sale will be set forth in the joint proxy
statement/prospectus when and if it is filed with the SEC in
connection with the proposed Merger and Asset Sale, at ReShape’s
website at www.reshapelifesciences.com.
Forward-Looking Statements
Certain statements contained in this filing may
be considered forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995, including
statements regarding the Merger and Asset Sale and the ability to
consummate the Merger and Asset Sale. These forward-looking
statements generally include statements that are predictive in
nature and depend upon or refer to future events or conditions, and
include words such as “believes,” “plans,” “anticipates,”
“projects,” “estimates,” “expects,” “intends,” “strategy,”
“future,” “opportunity,” “may,” “will,” “should,” “could,”
“potential,” or similar expressions. Statements that are not
historical facts are forward-looking statements. Forward-looking
statements are based on current beliefs and assumptions that are
subject to risks and uncertainties. Forward-looking statements
speak only as of the date they are made, and ReShape undertakes no
obligation to update any of them publicly in light of new
information or future events. Actual results could differ
materially from those contained in any forward-looking statement as
a result of various factors, including, without limitation: (1)
ReShape may be unable to obtain stockholder approval as required
for the proposed Merger and Asset Sale; (2) conditions to the
closing of the Merger or Asset Sale may not be satisfied; (3) the
Merger and Asset Sale may involve unexpected costs, liabilities or
delays; (4) ReShape’s business may suffer as a result of
uncertainty surrounding the Merger and Asset Sale; (5) the outcome
of any legal proceedings related to the Merger or Asset Sale; (6)
ReShape may be adversely affected by other economic, business,
and/or competitive factors; (7) the occurrence of any event, change
or other circumstances that could give rise to the termination of
the Merger Agreement or Asset Purchase Agreement; (8) the effect of
the announcement of the Merger and Asset Purchase Agreement on the
ability of ReShape to retain key personnel and maintain
relationships with customers, suppliers and others with whom
ReShape does business, or on ReShape’s operating results and
business generally; and (9) other risks to consummation of the
Merger and Asset Sale, including the risk that the Merger and Asset
Sale will not be consummated within the expected time period or at
all. Additional factors that may affect the future results of
ReShape are set forth in its filings with the SEC, including
ReShape’s most recently filed Annual Report on Form 10-K,
subsequent Quarterly Reports on Form 10-Q, Current Reports on Form
8-K and other filings with the SEC, which are available on the
SEC’s website at www.sec.gov, specifically under the heading “Risk
Factors.” The risks and uncertainties described above and in
ReShape’s most recent Annual Report on Form 10-K are not exclusive
and further information concerning ReShape and its business,
including factors that potentially could materially affect its
business, financial condition or operating results, may emerge from
time to time. Readers are urged to consider these factors carefully
in evaluating these forward-looking statements, and not to place
undue reliance on any forward-looking statements. Readers should
also carefully review the risk factors described in other documents
that ReShape files from time to time with the SEC. The
forward-looking statements in these materials speak only as of the
date of these materials. Except as required by law, ReShape assumes
no obligation to update or revise these forward-looking statements
for any reason, even if new information becomes available in the
future.
CONTACTS:
ReShape Lifesciences
Contact:Paul F. HickeyPresident and Chief Executive
Officer949-276-7223ir@ReShapeLifesci.com
Investor Relations Contact:Rx
Communications GroupMichael
Miller(917)-633-6086mmiller@rxir.com
|
RESHAPE LIFESCIENCES INC.Condensed
Consolidated Balance Sheets (in thousands, except share
amounts)(unaudited) |
|
|
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2025 |
|
2024 |
ASSETS |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
2,515 |
|
|
$ |
693 |
|
Restricted cash |
|
|
100 |
|
|
|
100 |
|
Accounts and other receivables (net of allowance for doubtful
accounts of $871 and $918 respectively) |
|
|
734 |
|
|
|
987 |
|
Inventory |
|
|
2,532 |
|
|
|
2,460 |
|
Prepaid expenses and other current assets |
|
|
414 |
|
|
|
348 |
|
Total current assets |
|
|
6,295 |
|
|
|
4,588 |
|
Property and equipment,
net |
|
|
34 |
|
|
|
38 |
|
Operating lease right-of-use
assets |
|
|
99 |
|
|
|
116 |
|
Deferred tax asset, net |
|
|
26 |
|
|
|
22 |
|
Other assets |
|
|
29 |
|
|
|
29 |
|
Total assets |
|
$ |
6,483 |
|
|
$ |
4,793 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
(DEFICIT) |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,686 |
|
|
$ |
2,208 |
|
Accrued and other liabilities |
|
|
2,158 |
|
|
|
1,688 |
|
Warranty liability, current |
|
|
163 |
|
|
|
163 |
|
Debt, current portion |
|
|
— |
|
|
|
811 |
|
Operating lease liabilities, current |
|
|
116 |
|
|
|
115 |
|
Total current liabilities |
|
|
4,123 |
|
|
|
4,985 |
|
Operating lease liabilities,
noncurrent |
|
|
14 |
|
|
|
41 |
|
Common stock warrant
liability |
|
|
1,116 |
|
|
|
20 |
|
Total liabilities |
|
|
5,253 |
|
|
|
5,046 |
|
Commitments and contingencies
(Note 2 and Note 10) |
|
|
|
|
|
|
Stockholders’ equity
(deficit): |
|
|
|
|
|
|
Preferred stock, 10,000,000 shares authorized: |
|
|
|
|
|
|
Series C convertible preferred stock, $0.001 par value; 95,388
shares issued and outstanding at March 31, 2025 and
December 31, 2024 |
|
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 300,000,000 shares authorized at
March 31, 2025 and December 31, 2024; 133,081
and 29,235 shares issued and outstanding at
March 31, 2025 and December 31, 2024,
respectively |
|
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
|
642,570 |
|
|
|
642,555 |
|
Accumulated deficit |
|
|
(641,230 |
) |
|
|
(642,704 |
) |
Accumulated other comprehensive loss |
|
|
(110 |
) |
|
|
(104 |
) |
Total stockholders’ equity (deficit) |
|
|
1,230 |
|
|
|
(253 |
) |
Total liabilities and stockholders’ equity (deficit) |
|
$ |
6,483 |
|
|
$ |
4,793 |
|
|
|
RESHAPE LIFESCIENCES INC. Condensed
Consolidated Statements of Operations (in thousands,
except share and per share amounts)(unaudited) |
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
2025 |
|
|
2024 |
|
Revenue |
|
$ |
1,113 |
|
|
$ |
1,944 |
|
Cost of revenue |
|
|
432 |
|
|
|
779 |
|
Gross profit |
|
|
681 |
|
|
|
1,165 |
|
Operating
expenses: |
|
|
|
|
|
|
Sales and marketing |
|
|
529 |
|
|
|
1,019 |
|
General and administrative |
|
|
1,627 |
|
|
|
1,872 |
|
Research and development |
|
|
364 |
|
|
|
484 |
|
Transaction costs |
|
|
367 |
|
|
|
— |
|
Total operating expenses |
|
|
2,887 |
|
|
|
3,375 |
|
Operating loss |
|
|
(2,206 |
) |
|
|
(2,210 |
) |
Other expense
(income), net: |
|
|
|
|
|
|
Interest expense (income), net |
|
|
40 |
|
|
|
(9 |
) |
Gain on changes in fair value of liability warrants |
|
|
(3,661 |
) |
|
|
(21 |
) |
Gain on extinguishment of debt |
|
|
(24 |
) |
|
|
— |
|
Loss on foreign currency exchange, net |
|
|
12 |
|
|
|
24 |
|
Other income, net |
|
|
(54 |
) |
|
|
(25 |
) |
Income (loss) before income
tax provision |
|
|
1,481 |
|
|
|
(2,179 |
) |
Income tax expense |
|
|
7 |
|
|
|
14 |
|
Net income (loss) |
|
$ |
1,474 |
|
|
$ |
(2,193 |
) |
Net income (loss) per
share - basic and diluted: |
|
|
|
|
|
|
Net income (loss) per share -
basic and diluted |
|
$ |
18.98 |
|
|
$ |
(135.37 |
) |
Shares used to compute basic
and diluted net income (loss) per share |
|
|
77,668 |
|
|
|
16,200 |
|
|
|
|
|
|
|
|
The following table contains a reconciliation of
GAAP net income (loss) to Adjusted EBITDA attributable to common
stockholders for the three months ended March 31, 2025 and 2024 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
2025 |
|
|
2024 |
|
GAAP net income (loss) |
$ |
1,474 |
|
|
$ |
(2,193 |
) |
Adjustments: |
|
|
|
|
|
Interest expense (income), net |
|
40 |
|
|
|
(9 |
) |
Income tax expense |
|
7 |
|
|
|
14 |
|
Depreciation and amortization |
|
4 |
|
|
|
6 |
|
Stock-based compensation expense |
|
15 |
|
|
|
72 |
|
Transaction costs |
|
367 |
|
|
|
— |
|
Gain on changes in fair value of liability warrants |
|
(3,661 |
) |
|
|
(21 |
) |
Gain on extinguishment of debt |
|
(24 |
) |
|
|
— |
|
Adjusted EBITDA |
$ |
(1,778 |
) |
|
$ |
(2,131 |
) |
ReShape Lifesciences (NASDAQ:RSLS)
과거 데이터 주식 차트
부터 6월(6) 2025 으로 7월(7) 2025
ReShape Lifesciences (NASDAQ:RSLS)
과거 데이터 주식 차트
부터 7월(7) 2024 으로 7월(7) 2025