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ReShape Lifesciences® Reports First Quarter Ended March 31, 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-05-21 12:31
Core Insights - ReShape Lifesciences Inc. is progressing towards completing a merger with Vyome Therapeutics and an asset purchase agreement with Biorad Medisys, which are expected to enhance its market position and operational capabilities [3][4][6]. Financial Performance - For Q1 2025, ReShape reported revenue of $1.1 million, a decrease of 42.7% or $0.8 million compared to Q1 2024, primarily due to reduced sales volume influenced by GLP-1 pharmaceutical weight-loss alternatives and a pause in direct-to-consumer marketing [8]. - Gross profit for the same period was $0.7 million, with a gross profit margin of 61.2%, up from 59.9% in Q1 2024, attributed to lower overhead costs [9]. - Sales and marketing expenses decreased by 48.1% to $0.5 million, while general and administrative expenses fell by 13.1% to $1.6 million, reflecting cost-saving measures [10][11]. - Research and development expenses also decreased by 24.8% to $0.4 million [12]. - The company recorded a gain of $3.7 million on changes in the fair value of liability warrants during Q1 2025 [14]. Strategic Developments - The merger with Vyome will result in the combined entity being renamed Vyome Holdings, Inc., with a focus on advancing immuno-inflammatory assets and exploring opportunities between the U.S. and India [3][6]. - ReShape has expanded its product portfolio through a distribution agreement with Motion Informatics for neuromuscular rehabilitation devices and a new distribution agreement for the enhanced Lap-Band 2.0 FLEX in Canada [6][7]. - The company has received multiple Notices of Allowance from the USPTO for patents related to its Diabetes Neuromodulation technology, extending intellectual property protection through at least 2039 [7]. Asset Transactions - ReShape will sell substantially all of its assets, including the Obalon Gastric Balloon System, to Biorad, which will assume most of ReShape's liabilities [5]. - The cash purchase price from the asset sale will contribute to determining post-merger ownership allocation between ReShape and Vyome stockholders [5]. Market Position - ReShape aims to strengthen its leadership in diabetes innovation and expand access to its minimally invasive weight-loss solutions, positioning itself as a key player in the obesity and metabolic health market [6][7].
ReShape Lifesciences (RSLS) - 2025 Q1 - Quarterly Report
2025-05-20 20:56
Financial Performance - Revenue for Q1 2025 was $1,113,000, a decrease of 42.6% compared to $1,944,000 in Q1 2024[106] - Gross profit margin improved to 61.2% in Q1 2025 from 59.9% in Q1 2024, despite a decrease in revenue[106] - Total operating expenses for Q1 2025 were $2,887,000, representing 259.4% of revenue, compared to $3,375,000 or 173.6% of revenue in Q1 2024[106] - The company reported a net income of $1,474,000 in Q1 2025, compared to a net loss of $2,193,000 in Q1 2024[106] - Adjusted EBITDA for Q1 2025 was $(1,778,000), an improvement from $(2,131,000) in Q1 2024[110] - Total revenue for the three months ended March 31, 2025, was $1.1 million, a decrease of 42.7% or $0.8 million compared to the same period in 2024[111] - Gross profit for the same period was $0.7 million, representing 61.2% of total revenue, an increase from 59.9% in 2024, attributed to reduced overhead costs[112] - Operating expenses totaled $2.9 million, a decrease of 14.5% from $3.4 million in 2024, with significant reductions in sales and marketing expenses by 48.1% to $0.5 million[114] - Net cash used in operating activities was $2.1 million for both the three months ended March 31, 2025, and 2024, primarily due to net income and changes in working capital[120] Mergers and Acquisitions - The company entered into a merger agreement with Vyome Therapeutics, focusing on advancing immune-inflammatory assets[95] - The company plans to merge with Vyome Therapeutics, Inc. and expand the Lap-Band product line domestically and internationally[127] - The company plans to sell substantially all assets to Biorad for a purchase price of $2.25 million, subject to adjustments[102] - Transaction costs for the three months ended March 31, 2025, were $0.4 million, related to the pending merger and asset sale[117] Product Development and Agreements - An exclusive distribution agreement was signed with Liaison Medical Ltd. for the Lap-Band® 2.0 FLEX system in Canada, effective until December 31, 2028[98] - A key international patent for Diabetes Neuromodulation technology was granted, providing protection until December 4, 2039[96] - Research and development expenses decreased by 24.8% to $0.4 million, primarily due to a pause in clinical trials[116] Financial Concerns - The company anticipates running out of cash by the fourth quarter of 2025, raising concerns about its ability to continue operations[128] - Future capital requirements for product development will depend on decisions made by Biorad after the pending asset sale[129] Stock and Shareholder Actions - A reverse stock split of 1-for-25 was executed on May 9, 2025, affecting the number of shares outstanding[104] - The company raised $4.8 million in February 2025 from a public offering, with $2.5 million in cash and cash equivalents as of March 31, 2025[118]
ReShape Lifesciences Announces 1-for-25 Reverse Stock Split
Globenewswire· 2025-05-07 12:31
Core Points - ReShape Lifesciences Inc. announced a 1-for-25 reverse stock split effective May 9, 2025, where every 25 shares will convert into one share [1] - The reverse stock split was approved by stockholders during a special meeting on April 1, 2025, and instructions for exchanging stock certificates will be provided by the transfer agent [2] - The company specializes in weight loss and metabolic health solutions, offering products like the FDA-approved Lap-Band System and investigational Diabetes Bloc-Stim Neuromodulation™ system [3] Company Overview - ReShape Lifesciences is recognized as a leading provider of weight loss and metabolic health solutions in the U.S. [3] - The company offers a range of products aimed at managing obesity and metabolic diseases, including non-surgical options like the Obalon balloon technology [3] - The Lap-Band System provides a minimally invasive treatment alternative to more invasive surgical procedures [3]
ReShape Lifesciences® Presents Pre-clinical Data on Its Proprietary Diabetes Neuromodulation Device at the 12th Annual Minnesota Neuromodulation Symposium
Globenewswire· 2025-05-02 12:31
Core Insights - ReShape Lifesciences is presenting pre-clinical data on its proprietary Diabetes Neuromodulation device at the 12th Annual Minnesota Neuromodulation Symposium, showcasing a novel approach to treating diabetes and hypoglycemia without cardiac side effects [1][4] Group 1: Technology and Mechanism - The Diabetes Neuromodulation technology employs Hypoglycemia Vagus Nerve Stimulation (HVNS) to stimulate the sub-diaphragmatic posterior vagus nerve, effectively increasing blood glucose levels during hypoglycemic episodes [3] - HVNS demonstrated the ability to raise blood glucose levels from a baseline of 45 mg/dL to 58 mg/dL and from 51 mg/dL to 68 mg/dL in a Type 1 diabetic swine model after 30 minutes of stimulation [3] - The technology avoids impacting heart rate, blood pressure, or respiration, addressing limitations of conventional vagal stimulation techniques [3][7] Group 2: Clinical Data and Efficacy - Pre-clinical results showed that HVNS increased glucagon levels from 4.1 pmol/L to 12.3 pmol/L and from 3.5 pmol/L to 7.6 pmol/L, indicating a significant physiological response [3] - The mean heart rate remained stable during stimulation, with vomiting only observed at higher amplitudes, suggesting a clear therapeutic window for effective treatment [3] Group 3: Future Development and Market Potential - The company plans to seek non-dilutive funding and collaborate with leading researchers and corporate partners to advance the commercialization of the Diabetes Neuromodulation device [4] - The ReShape Diabetes Neuromodulation system is positioned as a minimally invasive alternative to traditional diabetes management methods, potentially improving the quality of life for individuals with Type 1 or Type 2 diabetes [5][8]
ReShape Lifesciences® Receives Notice of Allowance for Key U.S. Patent Related to an Intragastric Balloon System
Globenewswire· 2025-04-28 12:31
Core Insights - ReShape Lifesciences has received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent application related to an intragastric balloon system, which includes a swallowable capsule and a degradable release valve designed for natural excretion after deflation [1][2] - The patent, once issued, will provide protection until at least January 2031, potentially extending further with a Patent Term Extension [1] - The company has secured over 50 patents related to its intragastric balloon system since its initial application in 2011, resulting in a total of more than 160 patents issued and pending [2] Company Overview - ReShape Lifesciences is a leading company in the weight loss and metabolic health solutions sector, offering a range of products and services aimed at managing obesity and metabolic diseases [3] - The company’s FDA-approved products include the Lap-Band and Lap-Band 2.0 Flex Systems, which provide minimally invasive treatments for obesity, and the Obalon balloon technology, a non-surgical, swallowable intra-gastric balloon [3] Recent Developments - ReShape Lifesciences has entered into an asset purchase agreement with Biorad Medisys, under which it will sell substantially all of its assets, including the Lap-Band System and Obalon Gastric Balloon System, to Biorad [4]
ReShape Lifesciences® Receives Notice of Allowance for Additional U.S. Patent Related to Its Proprietary Diabetes Neuromodulation Technology
Globenewswire· 2025-04-21 12:31
Core Insights - ReShape Lifesciences has received a Notice of Allowance for a patent on its Diabetes Neuromodulation system, which utilizes vagus nerve modulation to treat Type 2 diabetes and hypoglycemia, with patent protection extending until August 4, 2037 [1][2] - The technology is designed to regulate blood glucose levels through targeted vagal nerve modulation, using a unique energy-efficient algorithm that consumes approximately 10 times less energy than traditional methods, allowing for smaller devices and longer battery life [2][3] - The company has completed preclinical development, demonstrating the system's efficacy in boosting insulin production and managing blood glucose levels, while remaining compatible with standard implantable pulse generators [2][3] Company Overview - ReShape Lifesciences specializes in weight loss and metabolic health solutions, offering a range of products including the FDA-approved Lap-Band systems and non-surgical options like the Obalon balloon technology [4] - The company is in the process of selling its assets, including the Lap-Band System and the Diabetes Neuromodulation system, to Biorad Medisys, which will take ownership of the DBSN™ system upon closing the transaction [5] Technology Details - The ReShape Diabetes Neuromodulation system is a minimally invasive implant that delivers bio-electronic neuromodulation to regulate plasma glucose by stimulating the pancreas and blocking signals to the liver [3] - The system is designed to be reversible and adjustable, potentially representing a significant advancement in personalized medicine compared to existing vagus nerve stimulation methods [3] Intellectual Property - The company holds a robust intellectual property portfolio with 63 issued or pending patents covering various aspects of its technology, including vagal neuromodulation and glucose regulation, which supports its commercialization efforts [2]
ReShape Lifesciences (RSLS) - 2024 Q4 - Earnings Call Transcript
2025-04-11 02:09
Financial Data and Key Metrics Changes - Revenue for the year ended December 31, 2024, totaled $8,000,000, representing a contraction of 8% or $700,000 compared to the same period in 2023 [14] - Gross profit for the year ended December 31, 2024, was $5,100,000, a decrease of $500,000 or 9% from $5,500,000 in 2023 [14] - Gross profit margin slightly decreased to 63.2% from 63.9% in the previous year [14] - Operating expenses were reduced by almost 42% compared to the previous year, excluding M&A related costs [3][12] Business Line Data and Key Metrics Changes - Sales and marketing expenses decreased by $4,600,000 or 60% to approximately $3,000,000 compared to $7,500,000 in 2023, primarily due to a reduction in advertising and marketing expenses [15] - General and administrative expenses decreased by approximately $3,400,000 or 33% to approximately $6,900,000 compared to $10,300,000 in 2023 [15] - Research and development expenses decreased by $500,000 or 22% to $1,800,000 compared to $2,300,000 in 2023 [16] Market Data and Key Metrics Changes - The introduction of GLP-1 pharmaceuticals impacted revenue negatively, contributing to the overall revenue contraction [14] Company Strategy and Development Direction - The company is focused on a disciplined approach to executing a cost reduction plan while pursuing growth initiatives [3] - A significant partnership was established with Motion Informatics to distribute next-generation neuromuscular rehabilitation devices, expanding the product portfolio [4][5] - The company aims to enhance its product offerings through both organic development and strategic partnerships [8] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the merger with Viome and the concurrent asset sale to BI RAD, viewing these transactions as beneficial for shareholder value [18] - The company is committed to improving the quality of life for patients through innovative products and therapies [5][8] Other Important Information - The company successfully closed a $6,000,000 public offering in February 2025 to strengthen its financial position [4] - A notice of allowance for patents related to the diabetes Neuromodulation System was received, reinforcing the company's leadership in innovative treatments [10] Q&A Session Summary Question: What are the expectations regarding the merger with Viome? - Management indicated that the merger with Viome and the asset sale to BI RAD are expected to generate significant value and growth for shareholders [18]
ReShape Lifesciences® Partners with Motion Informatics to Bring AI-Driven Neurorehabilitation Technology to the U.S. Market
Globenewswire· 2025-04-09 20:05
Core Insights - ReShape Lifesciences has entered an exclusive distribution agreement with Motion Informatics to import and distribute neuromuscular rehabilitation devices in the U.S. market [1][2] - The flagship product, Stimel-03, integrates Functional Electrical Stimulation (FES), Neuromuscular Electrical Stimulation (NMES), and real-time electromyographic (EMG) biofeedback [2] - This partnership aims to enhance patient outcomes and expand the market reach of both companies in the neuromuscular rehabilitation sector [2][3] Company Overview - ReShape Lifesciences specializes in weight loss and metabolic health solutions, offering a range of products including the FDA-approved Lap-Band® System and investigational Diabetes Bloc-Stim Neuromodulation™ (DBSN™) system [4] - Motion Informatics focuses on next-generation neuromuscular rehabilitation, utilizing AI-driven neuroinformatics and augmented reality to create adaptive therapeutic platforms [3] - The collaboration positions both companies at the forefront of the neuromuscular rehabilitation market, aiming for global expansion and improved clinical care [2][3]
ReShape Lifesciences® Reports Year Ended December 31, 2024 Financial Results and Provides Corporate Update
Globenewswire· 2025-04-07 20:05
Core Insights - ReShape Lifesciences Inc. reported a significant reduction in overall operating expenses of 41.9% in 2024, excluding M&A related expenses, compared to 2023 [1] - The company entered into a definitive merger agreement with Vyome Therapeutics and an asset purchase agreement with Biorad Medisys, both of which are on track [1][3] - A strategic business update call is scheduled for April 10, 2025, to discuss these developments [1] Financial Performance - For the year ended December 31, 2024, ReShape reported revenue of $8.0 million, a decrease of 7.7% or $0.7 million compared to 2023 [8] - Gross profit for the same period was $5.1 million, down from $5.5 million in 2023, representing a decrease of 8.9% [9] - Operating expenses totaled $12.8 million in 2024, down from $20.9 million in 2023, reflecting significant cost-cutting measures [30] Expense Breakdown - Sales and marketing expenses decreased by 60.4% to approximately $3.0 million in 2024, primarily due to reduced advertising and marketing efforts [10] - General and administrative expenses fell by 32.9% to approximately $6.9 million, driven by reductions in legal, audit, and professional fees [11] - Research and development expenses decreased by 22.1% to $1.8 million, attributed to halted clinical trials and reduced consulting [12] Merger and Asset Sale - The merger with Vyome will result in ReShape being renamed Vyome Holdings, Inc., and the combined company will focus on immuno-inflammatory assets [3] - The asset purchase agreement with Biorad involves the sale of ReShape's key products, including the Lap-Band® System and Obalon® Gastric Balloon System [4] - The cash from the asset sale will contribute to determining post-merger ownership allocation between ReShape and Vyome stockholders [4] Patent Developments - In March 2025, ReShape received a Notice of Allowance for a patent related to its Diabetes Neuromodulation system, which will provide protection until April 12, 2039 [5] - An international patent was granted in February 2025 for the same technology, extending protection until December 4, 2039 [5] Market Position and Strategy - The company aims to expand access to its next-generation Lap-Band® 2.0 FLEX through a distribution agreement in Canada [7] - The introduction of GLP-1 pharmaceuticals in the U.S. has impacted revenue, despite a slight growth in units sold of the Lap-Band [8] - The strategic moves, including the merger and asset sale, are expected to create significant value and growth for shareholders [7]
ReShape Lifesciences (RSLS) - 2024 Q4 - Annual Report
2025-04-04 20:10
Financial Performance - Revenue for the year ended December 31, 2024, was $8,006,000, a decrease of 7.7% compared to $8,678,000 in 2023[397] - Gross profit margin for 2024 was 63.2%, down from 63.9% in 2023, with gross profit amounting to $5,057,000[397] - The net loss for 2024 was $7,130,000, a reduction of 37.5% from the net loss of $11,387,000 in 2023[397] - Adjusted EBITDA for 2024 was $(6,320,000), an improvement from $(13,575,000) in 2023[402] - Total revenue for the year ended December 31, 2024, was $8.0 million, a decrease of 7.7% or $0.7 million compared to 2023[403] - Gross profit for 2024 was $5.1 million, down 8.9% from $5.5 million in 2023, with a gross profit margin of 63.2% compared to 63.9% in 2023[404] Operating Expenses - Total operating expenses for 2024 were $12,785,000, representing 159.7% of revenue, compared to $20,931,000 or 241.3% of revenue in 2023[397] - Operating expenses decreased by 38.9% to $12.8 million in 2024 from $20.9 million in 2023, primarily due to significant reductions in sales and marketing expenses[405] - Sales and marketing expenses dropped by 60.4% to approximately $3.0 million in 2024, down from $7.5 million in 2023[405] - General and administrative expenses decreased by 32.9% to approximately $6.9 million in 2024, compared to $10.3 million in 2023[406] - Research and development expenses fell by 22.1% to $1.8 million in 2024, down from $2.3 million in 2023[407] Cash Flow and Financing - Net cash used in operating activities was $4.4 million in 2024, a significant improvement from $17.0 million in 2023[415] - The company raised $0.7 million from financing activities in 2024, compared to $17.6 million in 2023[420] - In February 2025, the company raised $4.5 million in a public offering, which will be used for operations and transaction costs[422] Mergers and Agreements - The company entered into a merger agreement with Vyome Therapeutics, focusing on advancing immune-inflammatory assets[385] - The company plans to merge with Vyome Therapeutics, Inc. and expand the Lap-Band product line both domestically and internationally[421] - An exclusive distribution agreement was established with Liaison Medical Ltd. for the Lap-Band® 2.0 FLEX system in Canada, effective until December 31, 2028[388] Intellectual Property and Technology - The company was granted a key international patent for its Diabetes Neuromodulation technology, valid until December 4, 2039[386] Asset Management - The company plans to sell substantially all of its assets to Ninjour Health International Limited for a purchase price of $5.16 million[392] - A reverse stock split of 1-for-58 was executed on September 23, 2024, affecting the number of shares outstanding[396] Revenue Recognition and Accounting - Revenue is recorded net of taxes collected from customers, with amounts billed for shipping and handling included in revenue[430] - Customers of the Lap-Band product can return or exchange products within 30 days, subject to a 10% restocking fee, impacting revenue recognition[431] - Volume rebates or discounts for Lap-Band customers are treated as reductions in sales price and revenue at the point of sale[432] - The company is assessing the impact of competing products, clinical device costs, and regulatory approvals on future revenue generation[433] Reserves and Valuation - Warranty reserves are established based on specific assessments of claims related to product defects, with a five-year warranty provided for the vBloc product line[435][436] - Stock-based compensation expenses are measured based on estimated fair values using the Black-Scholes option valuation model[437] - Accounts receivable reserves are provided for estimated losses based on customer-specific analysis and current economic conditions[438] - Inventory reserves for obsolescence are established based on specific identification of expired or unusable units[439] - The fair value of warrants is analyzed to determine their classification as liability or equity, using various valuation models[440] - Recent accounting standards have been adopted and discussed in the financial statements[441]