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]

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]

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]

Core Insights - ReShape Lifesciences has received a Notice of Allowance for a patent on a novel Diabetes Neuromodulation system, which aims to improve glycemic control and reduce medication dependence for Type 2 diabetes patients [1][2] - The patent will provide protection until April 12, 2039, and is part of a broader intellectual property portfolio that includes 62 issued or pending patents [2] - The Diabetes Neuromodulation technology utilizes proprietary vagus nerve block (vBloc™) technology to regulate blood glucose levels by modulating the vagus nerve's influence on the liver and pancreas [2][3] Company Overview - ReShape Lifesciences is a leading company in weight loss and metabolic health solutions, offering a range of products including the FDA-approved Lap-Band systems and Obalon balloon technology [4] - The company is transitioning its assets, including the DBSN™ system, to Biorad Medisys, which will own the system following the asset purchase agreement [5] Technology and Research - The Diabetes Neuromodulation system is a minimally invasive implant that delivers bio-electronic neuromodulation to regulate plasma glucose levels [3] - Pre-clinical studies have demonstrated improved glycemic control in animal models of Type 2 diabetes, indicating the potential effectiveness of the technology [2]

Core Insights - ReShape Lifesciences has signed a distribution agreement with Liaison Medical for the Lap-Band 2.0 FLEX and Tubing Kit in Canada, following Health Canada's approval in November 2024 [1][2] - The Lap-Band 2.0 FLEX features a relief valve technology that alleviates discomfort from swallowing large pieces of food, potentially reducing the need for in-office adjustments [2] - Liaison Medical is one of the largest surgical device distributors in Canada, leveraging its relationships with hospitals to promote the new device [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 the investigational Diabetes Bloc-Stim Neuromodulation™ system [4] - Liaison Medical, founded in 2012, focuses on delivering innovative surgical devices to hospitals and aims to provide exclusive products to customers while fostering growth for its suppliers [3]

Core Viewpoint - ReShape Lifesciences has announced a public offering of 2,575,107 units at a price of $2.33 per unit, aiming to raise approximately $6.0 million before expenses [1][2]. Group 1: Offering Details - Each unit in the offering consists of one common share (or a pre-funded warrant) and one warrant to purchase one common share [1]. - The warrants are initially exercisable at $5.83 per share and are subject to adjustments for dividends and splits, with a one-time reset on a specified date [2]. - The offering is expected to close on or about February 18, 2025, pending customary closing conditions [2]. Group 2: Company Overview - ReShape Lifesciences is a leading company in weight loss and metabolic health solutions, offering products like the FDA-approved Lap-Band systems and the ReShape Diabetes Neuromodulation system [6]. - The company provides minimally invasive treatments for obesity and metabolic diseases, positioning itself as an alternative to more invasive surgical procedures [6].

Core Insights - ReShape Lifesciences has been granted an international patent for its Diabetes Neuromodulation technology, which aims to improve glycemic control in Type 2 diabetes patients [1][2] - The patent, valid until December 4, 2039, supports the company's proprietary vBloc™ technology, which combines vagus nerve block and stimulation [1][2] - The technology has shown promise in reducing medication reliance for diabetics, potentially lowering treatment costs and complications [2] Company Overview - ReShape Lifesciences is a leading company in weight loss and metabolic health solutions, offering a range of products including the FDA-approved Lap-Band® and Obalon® systems [4] - The company has a strong intellectual property portfolio with 62 issued or pending patents related to vagal neuromodulation and glucose control [2] - ReShape is in the process of selling its assets, including the Lap-Band® and Obalon® systems, to Biorad Medisys, which will also acquire the DBSN™ system [5] Technology Details - The ReShape Diabetes Neuromodulation system is a minimally invasive implant that utilizes bio-electronic neuromodulation to regulate plasma glucose levels [3] - The system works by stimulating pancreatic vagus celiac fibers to release insulin while blocking the hepatic vagal branch to decrease glucose release [3] - Pre-clinical studies have demonstrated increased glycemic control in animal models of Type 2 diabetes [2][3]

Core Viewpoint - ReShape Lifesciences Inc. and Vyome Therapeutics, Inc. are merging in an all-stock transaction to create a company focused on immuno-inflammatory diseases and leveraging the U.S.-India innovation corridor [1][2][5] Company Overview - ReShape Lifesciences is a leading company in weight loss and metabolic health solutions, offering products like the FDA-approved Lap-Band® System and the investigational Diabetes Bloc-Stim Neuromodulation™ (DBSN™) system [9] - Vyome Therapeutics is a clinical-stage company targeting immuno-inflammatory and rare diseases, aiming to build a healthcare platform that spans the U.S.-India innovation corridor [6][7] Merger Details - The merger agreement was finalized on July 9, 2024, with ReShape to be renamed Vyome Holdings, Inc. and trading under the ticker symbol "HIND" [2] - The board of the combined company will consist of six directors from Vyome and one from ReShape, with Vyome's executive officers leading the management [2] Asset Purchase Agreement - Concurrently with the merger, ReShape entered into an asset purchase agreement with Biorad Medisys, selling substantially all of its assets, including the Lap-Band® System and Obalon® Gastric Balloon System [3] - The cash from the asset sale will contribute to ReShape's net cash for determining post-merger ownership allocation [3] Regulatory Filings - ReShape filed a Form S-4 registration statement with the SEC on October 1, 2024, and an amendment on December 6, 2024, related to the merger [4] - An additional Form S-1 registration statement for an Equity Line of Credit (ELOC) was filed on December 20, 2024, to support general operations and merger-related expenses [4] Leadership Statements - The CEO of ReShape expressed confidence that the merger and asset sale will maximize shareholder value and unlock significant potential for the combined entity [5] - Vyome's current director, who will become the Chairman of the combined company, emphasized the goal of developing new therapies for chronic immune-inflammatory conditions efficiently [5]

Financial Data and Key Metrics Changes - Revenue increased by 16.6% in Q3 2024 compared to Q2 2024, marking the third consecutive quarter of revenue growth, and a 6.4% increase compared to Q3 2023 [6] - Gross profit margin rose to 62.8% for Q3 2024 and 60.3% for the first nine months of 2024, attributed to cost reduction efforts [8] - Non-GAAP adjusted EBITDA improved to $1.6 million for Q3 2024, compared to a loss of $2.9 million in the same period last year, and a loss of $5.6 million for the nine months ended September 30, 2024, compared to $12 million for the same period last year [33] Business Line Data and Key Metrics Changes - Sales and marketing expenses decreased by 60% to $700,000 for Q3 2024 compared to $1.8 million for the same period in 2023, and decreased by 61% for the nine months ended September 30, 2024 [27] - Research and development expenses decreased by 26% to $400,000 for Q3 2024 compared to $500,000 for the same period in the prior year [32] Market Data and Key Metrics Changes - The obesity market is viewed as an untapped opportunity, with only about 10% adoption of GLP-1s among clinically obese individuals needing medical attention [56] - The company anticipates an increase in individuals seeking medical intervention for obesity as the stigma around it decreases [14] Company Strategy and Development Direction - The company is focused on executing a cost reduction plan for 2024, achieving over 40% lower operating expenses for the first nine months of the year compared to last year [7] - The merger with Vyome Therapeutics is seen as a significant opportunity for shareholders, with a combined valuation of approximately $130 million [36] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the potential for increased market share in the obesity treatment sector as more individuals seek less invasive options [55] - The company is excited about the growth potential resulting from the merger with Vyome and the concurrent asset sale to Biorad [20] Other Important Information - The company received a supplementary grant of approximately $241,000 from NIH for studies related to its proprietary Diabetes Bloc-Stim Neuromodulation device [10] - The company regained compliance with NASDAQ after a 1-for-58 reverse stock split, which was critical for the merger with Vyome [20] Q&A Session Summary Question: Can you talk about the 1953 gel and plans to target malignant fungating wounds? - Management deferred detailed scientific discussion until the investor deck is released, but highlighted that malignant fungating wounds represent a rare unmet disease and are part of Vyome's immuno-inflammation therapy focus [48][49] Question: Will the investor presentation outline the strategy for programs like the 1953 and 1908? - Management confirmed that the presentation will include information on the three different molecules and the catalysts they intend to pursue [53] Question: Do you think there will be a shift towards Lap-Band as people break the stigma of obesity? - Management indicated that there is potential for increased interest in less invasive options like Lap-Band as individuals experience diminishing returns from GLP-1s [55]

Revenue Performance - Revenue increased by 16.6% in Q3 2024 compared to Q2 2024, totaling $2.3 million, and a 6.4% increase compared to Q3 2023[9] - Total revenue for the three months ended September 30, 2024, was $2,292,000, representing an increase of 6.4% compared to $2,155,000 for the same period in 2023[27] Operating Expenses - Operating expenses decreased by 40.6% in the first nine months of 2024 compared to the same period in 2023, contributing to a gross profit margin of over 60%[7] - Operating expenses decreased significantly to $3,200,000 for the three months ended September 30, 2024, from $5,168,000 in the prior year, primarily due to reduced sales and marketing expenses[27] - General and administrative expenses decreased by 30.4% in the first nine months of 2024 to $6.1 million, driven by reductions in professional services and payroll-related expenditures[14] - Sales and marketing expenses decreased by 59.9% in Q3 2024 to $0.7 million, reflecting a shift to targeted digital marketing campaigns[12] - The company reported a significant reduction in sales and marketing expenses to $719,000 for the three months ended September 30, 2024, down from $1,791,000 in the same period last year[27] - Research and development expenses decreased by 26.4% in Q3 2024 to $0.4 million, primarily due to reduced payroll and consulting services[15] - Research and development expenses were $399,000 for the three months ended September 30, 2024, compared to $542,000 in the prior year, indicating a focus on cost management[27] Financial Performance - The net loss for the three months ended September 30, 2024, was $1,581,000, compared to a net loss of $3,534,000 for the same period in 2023, reflecting improved financial performance[27] - Cash and cash equivalents decreased to $743,000 as of September 30, 2024, down from $4,459,000 at the end of 2023, indicating liquidity challenges[26] - Total current assets fell to $5,338,000 as of September 30, 2024, compared to $10,296,000 at December 31, 2023, highlighting a decline in asset base[26] - Total liabilities increased to $4,128,000 as of September 30, 2024, from $4,000,000 at the end of 2023, suggesting rising financial obligations[26] Strategic Developments - The company received a supplementary grant of approximately $241,000 from the NIH for the development of next-generation electrodes for the DBSN™ device[3] - A merger agreement was entered into with Vyome Therapeutics, with existing ReShape stockholders expected to own approximately 11.1% of the combined company post-merger[5] - An asset purchase agreement was signed with Biorad Medisys for $5.16 million in cash, involving the sale of key assets including the Lap-Band® System and the DBSN™ System[6] - Health Canada approved the next-generation Lap-Band® 2.0 FLEX, marking a significant milestone for the company's product offerings[2] Compliance and Guidance - The company regained compliance with Nasdaq following a 1-for-58 reverse stock split effective September 23, 2024[8] - The company has not provided specific guidance for future performance but has indicated ongoing efforts to improve operational efficiency and reduce costs[27]