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HIND

VyomeF
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-06-02
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2026-05-28
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Earnings documents stored for HIND.

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Investor releaseQuarter not tagged2026-05-28

Vyome Holdings Reports First Quarter 2026 Results With Key FDA Filings and Strong Balance Sheet

Business Wire

Vyome has signed an agreement with Impetis Biosciences Limited, a TATA Enterprise, to in-license two selective JAK inhibitor assets, opening access to a large and growing ~$57B global market1 VT-1953 regulatory submissions to the FDA for Orphan Drug Designation status and proposals for constructive FDA guidance on the next steps of development Company ends Q1 2026 with approximately $8.8 million in cash and cash equivalents while maintaining a clean capital structure with no debt, no preferred stock, and no toxic financing instruments CAMBRIDGE, Mass., May 28, 2026--(BUSINESS WIRE)--Vyome Holdings, Inc. (Nasdaq: HIND)("Vyome"), a clinical-stage biopharmaceutical company focused on immuno-inflammatory and rare disease conditions, today reports financial results for the first quarter ended March 31, 2026, and provides a corporate update. Krishna Gupta, Chairman of Vyome, said, "Over the last several quarters, Vyome has executed with focus and discipline, advancing differentiated programs in areas of significant unmet medical need focused on inflammatory disorders. Inflammation remains one of the world’s largest problems, and we believe Vyome is well positioned for long-term value creation. We continue to strengthen our scientific, operational, and governance foundation while remaining highly disciplined on capital structure and shareholder alignment." Venkat Nelabhotla, CEO of Vyome, stated, "We continue to advance VT-1953 toward pivotal-stage readiness while maintaining a strong focus on disciplined execution, regulatory engagement, manufacturing preparedness, and financial stewardship. We submitted to the FDA an application for the approval of orphan drug designation status and proposals across several areas of the next stages of development readiness, and continue to believe VT-1953 addresses a major unmet need in malignant fungating wounds, where there are currently no FDA-approved therapies specifically addressing the condition." "Importantly, we have continued to preserve what we believe is one of the Company’s key differentiators: a clean and disciplined capital structure with no debt, no preferred stock, and no toxic financing instruments. We remain focused on creating long-term shareholder value while advancing our immuno-inflammatory and rare disease strategy," concluded Mr. Nelabhotla. First Quarter 2026 and Recent Corporate Highlights Regulatory su...

Investor releaseQuarter not tagged2026-03-31

Vyome Holdings Inc (HIND) Q4 2025 Earnings Call Highlights: Strategic Advances Amid Financial ...

GuruFocus.com

This article first appeared on GuruFocus. Operating Expenses: Approximately $3 million for the year ended December 31, 2025. Net Loss: Approximately $10.45 million, primarily due to one-time merger and financing-related expenses of approximately $7.7 million. Cash and Cash Equivalents: Approximately $5 million as of December 31, 2025. Additional Financing: Approximately $5.3 million in 2026 from the ATM agreement. Total Assets: Approximately $6.5 million. Total Liabilities: Approximately $2.7 million. Stockholders' Equity: Approximately $3.8 million. Debt: No debt, maintaining a clean capital structure. Warning! GuruFocus has detected 2 Warning Signs with HIND. Is HIND fairly valued? Test your thesis with our free DCF calculator. Release Date: March 30, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Vyome Holdings Inc (NASDAQ:HIND) reported strong Phase 2 data for VT-1953, showing statistically significant improvements in key areas such as mal-order, quality of life, and pain reduction. The company has a strong cash position and a clean capital structure with no debt, which supports its operations through mid-2027. Vyome Holdings Inc (NASDAQ:HIND) has applied for orphan drug designation with the FDA for VT-1953, indicating progress in regulatory development. The estimated US addressable market for VT-1953 is approximately $2.2 billion, presenting a significant market opportunity. The company is advancing VT-1908, a proprietary eye drop for uveitis, which could provide significant market value by addressing issues caused by standard steroid treatments. Vyome Holdings Inc (NASDAQ:HIND) reported a net loss of approximately $10.45 million for the year ended December 31, 2025, primarily due to one-time merger and financing-related expenses. The company's total assets were approximately $6.5 million, which may limit its financial flexibility. There is uncertainty regarding the successful FDA approval of VT-1953, which is crucial for the company's future growth. The company's financial strategy heavily relies on disciplined cost management and efficient capital allocation, which may be challenging to maintain. The anticipated pivotal study final readouts for VT-1953 are not expected until the end of 2027, indicating a long timeline before potential market entry. Q: Can you provide more details on the progre...

Investor releaseQuarter not tagged2026-03-26

Vyome Reports Transformational 2025 Results: Company Well Positioned for Breakout Phase

Business Wire

Completed a streamlined Nasdaq listing through a merger transaction, with a common stock capital structure and no preferred stock or debt Delivered positive final Phase 2 results for VT-1953 in treating symptoms of malignant fungating wounds, in line with expectations Independent valuation consulting firm, Destum Partners, valued VT-1953 at approximately $1 billion after a successful pivotal study Disciplined, cost-efficient operations as Vyome burned less cash than expected, giving the company a cash runway expected to extend through mid 2027, taking it up to pivotal trial interim readouts Added a new CTO, SVP of Clinical Development, and Senior Medical Advisor, bringing Big Pharma backgrounds, deep drug-development expertise, and experience across multiple FDA-approved therapies CAMBRIDGE, Mass., March 26, 2026--(BUSINESS WIRE)--Vyome Holdings, Inc., ("Vyome") (Nasdaq: HIND), a next-generation inflammation-focused company leveraging the US-India innovation corridor, today announced its financial results and corporate and clinical milestones following its successful listing on Nasdaq. This quarter marks Vyome’s first annual reporting period as a listed Nasdaq company. Vyome is a clinical-stage company positioned to accelerate development across immuno-inflammatory and potential orphan indications. "Vyome is targeting one of the biggest challenges in the world today - inflammation. So many of our medical and mental problems are linked to increased inflammation. We are building our business with a laser focus on shareholder value, whether it’s our capital structure or the development of our assets," said Krishna Gupta, Chairman of Vyome. "We had a great first fiscal year completion as a public company, thanks to our unique strengths, including expertise in/access to the US-India innovation corridor." "This annual reporting marks a defining step forward for Vyome. We executed a highly efficient transition to the public markets, spending less cash than expected in 2025 as a public company and strengthening our organization while advancing our lead program," noted Venkat Nelabhotla, CEO of Vyome. "The promising final Phase 2 results for VT-1953 reinforce the scientific promise of our immuno-inflammation platform. With our disciplined operations, clean capital structure, and world-class team, we are well-positioned to deliver on the milestones ahead and drive lon...

Investor releaseQuarter not tagged2026-02-18

Vyome Announces the Publication of Positive Preclinical Results in Uveitis, Addressing a $3B Potential Market Opportunity

Business Wire

VT-1908 was demonstrated to be effective as a topical steroid in the uveitis preclinical model and shows very good safety Plans to generate human clinical data using the India innovation corridor in a very cost-efficient manner No change in capital deployment plan; laser focused on our lead program, VT-1953 (for treatment of malodor of MFW), Phase 3 study CAMBRIDGE, Mass., February 18, 2026--(BUSINESS WIRE)--Vyome Holdings, Inc. ("Vyome") (Nasdaq: HIND) announced the publication of its preclinical data validating the efficacy and safety of VT-1908 as a potential treatment for uveitis in the peer-reviewed Journal of Ophthalmic Inflammation and Infection, a Springer-Nature journal1. Uveitis refers to the immune-inflammation of the eye, and accounts for 10–15% of all cases of blindness in the developed world2. In the United States alone, it is associated with an estimated 30,0003 new cases of legal blindness annually, and represents an estimated $3 billion market opportunity by 20324. Topical steroids are the standard first line of treatment for uveitis. However, many patients experience inadequate response, and prolonged steroid use is associated with major complications, including cataract formation and increased pressure in the eye, leading to glaucoma. In this publication1, topical eye drops of VT-1908 resulted in the desired concentration of the active drug being achieved in the eye without any irritation or signs of toxicity. VT-1908-treated eyes showed a significant reduction (p < 0.0010) in the uveitis score with reduced lymphocyte counts in the anterior chamber compared to vehicle control. VT-1908 was found to be as effective as topical prednisone (steroid) in the preclinical model. "There remains a significant unmet need for safe and effective topically administered therapies to replace topical steroid use in the treatment of ocular inflammation. While steroids are widely used, they are associated with well-documented complications. The fact that VT-1908 was as effective as a steroid in the uveitis preclinical model and shows a very good safety profile supports its potential as an effective alternative to steroids in the eye," said Shiladitya Sengupta, Associate Professor of Medicine at Harvard Medical School and Co-founder of Vyome. "The publication of this paper in the peer-reviewed Springer-Nature journal underscores the scientific rigor underlying...

Investor releaseQuarter not tagged2026-02-02

Vyome Successfully Capitalizes All VT-1953 Funding Requirements For Initial Phase 3 Results

Business Wire

Company Chose Minimal Dilution Path with No Warrants and Has Sufficient Liquidity to Deliver Initial Phase 3 Results for MFW product CAMBRIDGE, Mass., February 02, 2026--(BUSINESS WIRE)--Vyome Holdings, Inc. ("Vyome" or the "Company") (Nasdaq: HIND) announced it has successfully funded the budget for its VT-1953 Phase 3 study, which provides the Company sufficient capital to fund the estimated costs to release Phase 3 interim results on the efficacy of its drug focused on symptoms of Malignant Fungating Wounds ("MFW"). The Company accomplished this funding need using its existing At-The-Market ("ATM") facility. Additional details on this funding are as follows: All additional funds were raised on January 27, 2026. 1,089,045 common shares were sold at an average price of $5.00. This sales price represents a 59.2% premium to the prior day’s per-share closing price of $3.11. Net proceeds to the Company were approximately $5.29 million. The total dilution to existing shareholders as a result of this funding represents approximately 15% dilution, bringing the total current common shares issued and outstanding to 7,008,882 as of January 29, 2026. As of January 29, 2026, the Company had $9.5 million in cash on hand. "We have always been focused on shareholder value and are extremely pleased to report we have successfully funded our most important project’s estimated costs until interim findings anticipated in mid-2027," commented Krishna Gupta, Chairman of Vyome. "Inflammation is one of the biggest problems facing the world, and symptoms of MFW are our first target, via VT-1953, in immune-inflammation. As we recently disclosed in an independent valuation report, VT-1953 is estimated by a third party to be worth $1 billion upon anticipated completion of the Phase 3 clinical trials in approximately 18 months. To have achieved this funding at relatively minimal dilution – while turning down funding options at much higher dilution – shows our focus on shareholder value." "In the last week, we were aggressively solicited by multiple investment banks offering larger blocks of capital, but with warrants, investor rights, and other strings attached that we believe would have been harmful to our shareholders," added Venkat Nelabhotla, CEO of Vyome. "Instead, we sourced the absolute lowest cost of capital, with no warrants, and we believe that we are now very well-funded to...

Investor releaseQuarter not tagged2025-12-08

Vyome Reports Positive Final Phase 2 Results for VT-1953; Plans to Advance Into Pivotal Study For FDA Approval

Business Wire

VT-1953 treatment over 14 days resulted in highly statistically significant improvements in bad smell or malodor associated with malignant fungating wound (primary endpoint) (P = 0.002). Patient-reported impact of bad smell or malodor on quality of life (secondary endpoint) improved significantly (P = 0.0256), as did wound pain reduction (P = 0.002) VT-1953 was well-tolerated, with no new safety concerns observed. Based on these positive Phase 2 results, the company plans to advance VT-1953 into a pivotal study following discussions with the FDA to seek approval to enter $1B potential addressable market opportunity. CAMBRIDGE, Mass., December 08, 2025--(BUSINESS WIRE)--Vyome Holdings, Inc. ("Vyome") (Nasdaq: HIND) announced the final results from an investigator-initiated Phase 2 proof of concept study of VT-1953 topical gel in people with malignant fungating wounds ("MFW"). VT-1953, a first-in-class immunomodulator for this indication, achieved both its primary and secondary endpoints. With this result, Vyome plans to advance to Phase III pivotal trial, seek FDA approval, and enter the $1B potential addressable market as the only anticipated approved solution for malignant fungating wounds. "These are exciting results for Vyome, both in our primary and secondary endpoints. Inflammation is one of the greatest problems in the world today, and our study on malignant fungating wounds showed that those who received our drug VT-1953 had significant and rapid improvements in symptoms, quality of life, and emotional and physical functions. These positive results give us high confidence as we design a very cost-efficient pivotal study for FDA approval and a real opportunity to solve an important unmet need, a billion-dollar addressable market opportunity," said Dr. Shiladitya Sengupta, co-founder and director of Vyome and Associate Professor of Medicine at Harvard Medical School. MFW is a debilitating condition that occurs in 5-14% of advanced cancer patientsi. It is estimated that there are over 693,000 patients with advanced cancer in the US alone and approximately 10M globally. Cancer cells break through the skin and cause a chronic wound (MFW), which is extremely distressing to patients, given the high burden of symptoms, including extreme bad smell, severe pain, a feeling of shame, low self-esteem, and social isolationii. On the primary endpoint of bad smell or...

TranscriptFY2025 Q32025-11-20

FY2025 Q3 earnings call transcript

Earnings source - 10 paragraphs
Operator

Good morning and welcome to the Vyome Holdings Q3 2025 earnings call. At this time, all participants are in listen-only mode. Please note that today's discussion may include forward-looking statements, which are subject to risks and uncertainties. A full safe harbor disclosure appears in the company's press release. Now, I'd like to turn the call over to Venkat Nalabhotra, co-founder, President, and CEO of Vyome Holdings. Please go ahead.

Venkat Nelabhotla

Thank you, Shimali. Good morning, everyone. I'm very happy to share Vyome's first full reporting period as a publicly listed company. This quarter marks a significant step forward for our organization, and I'm pleased to report we are executing according to plan. We completed a streamlined NASDAQ listing with a 100% common stock structure, advanced early program VT1953 on schedule, and maintained the cost discipline central to our strategy. Our runway extends through 2026 as planned, and I'm particularly pleased to share that our disciplined spending model resulted in a lower cash burn than we had anticipated, demonstrating our operational efficiency while advancing our programs. On the team front, we strengthened our leadership by hiring a Chief Technology Officer and Senior Vice President of Clinical Development, both bringing big pharma backgrounds, deep drug development expertise, and experience across multiple FDA-approved therapies.

Venkat Nelabhotla

These additions strengthen our ability to execute on our pipeline programs. With a world-class team in place, we are focused on addressing inflammation, one of the largest challenges in global health, representing an addressable market opportunity of more than $120 billion. Our unique position, bridging the U.S. and India innovation corridors, gives us a strategic advantage. It provides access to world-class scientific talent, cost-efficient clinical trial infrastructure, and diverse patient populations, enabling us to develop therapies more rapidly and economically than traditional models while maintaining rigorous regulatory standards. Let me turn now to our lead program, VT1953. This quarter, we delivered encouraging interim phase two results for VT1953 in treating symptoms of malodor and pain of malignant fungating wounds, or MFW. We saw a significant reduction in malodor, the primary endpoint, measured by the Killer-Oder scale.

Venkat Nelabhotla

Patients also reported less lesion pain on a visual analog scale and improved quality of life. Importantly, no clinically significant adverse effects were observed with VT1953. For those unfamiliar with this condition, MFW is devastating. It affects 5%-14% of advanced cancer patients and often leads to severe emotional and social isolation due to extremely malodorous wounds that prevent interaction with family and friends. Representing a potential $1 billion addressable market opportunity in the United States, currently, there are no FDA-approved treatments for MFW. Therefore, a potentially significant demand from clinicians and patients for VT1953, with it anticipated to be the only approved drug. We are advancing it as a potential orphan drug candidate with full phase two data from our investigator-initiated trial expected in December 2025. These interim results validate our thesis that effective therapies can be developed through smartly designed and cost-efficient trials.

Venkat Nelabhotla

Moving to our second program, VT1908. We previously reported strong preclinical efficacy for VT1908 eye drops in uveitis models, reinforcing its promise as a highly needed steroid-sparing candidate. In a preclinical model of anterior uveitis, the most common form of the disease, twice daily, VT1908 eye drops significantly reduce the uveitis score. Notably, its efficacy was comparable to that of a clinically used steroid, underscoring the promise of VT1908 as a non-steroidal treatment option. FDA interactions are planned for the first half of 2026, alongside continued development activities to advance the program toward clinical readiness. Beyond our novel drug pipeline, we are also exploring the development of an AI-focused healthcare initiative through the acquisition of Oculos and MIT Spinout.

Venkat Nelabhotla

To wrap up, with our king capital structure, disciplined operations, and world-class team, we are well positioned to deliver on upcoming milestones and drive long-term value for both patients and shareholders. I'll now turn the call over to our CFO, Rob Dickey, to discuss financials.

Rob Dickey IV

Thanks, Venkat, and good morning to everyone. I'll walk you through the financial highlights for the quarter ended September 30. We ended the quarter with cash, cash equivalents, and short-term investments totaling approximately $5.7 million, which we believe provides a runway through 2026, inclusive of planned clinical activities. Research and development and general administrative expenses reflect pre- and post-merger costs, and the net loss of $9.2 million primarily includes one-time transaction and non-cash financing charges associated with the merger. As noted in our press release, our outstanding common shares count stood at 5,556,295 shares, and we have no preferred stock, warrants, or convertible notes outstanding, maintaining a clean capital structure. Our disciplined spending model resulted in lower cash burn than anticipated, a development that we're pleased with given our strategic focus. Looking ahead, we remain committed to cost-efficient operations as we advance our pipeline.

Rob Dickey IV

I will now turn the call back to Venkat for closing remarks.

Venkat Nelabhotla

Thanks, Rob. Today marks a defining step for Vyome. Our strategic pillars, biotech pipeline, AI-enabled healthcare, provide multiple pathways to innovation, growth, and value creation. With our programs now in motion and regulatory engagement planned for the first half of 2026, we enter the next phase with momentum and clarity. Thank you to our team, partners, and shareholders for their support. We look forward to sharing continued progress. Thank you.

Operator

Thank you, and that concludes today's prepared remarks. Please note that we will not be taking questions on this call. Any questions may be submitted via email to [email protected]. Thank you for your participation in Vyome Holdings Q3 2025 earnings call.

Investor releaseQuarter not tagged2025-11-18

Vyome Holdings Announces Transformational First Quarter Following Nasdaq Listing

Business Wire

(Quarter Ended September 30, 2025) CAMBRIDGE, Mass., November 18, 2025--(BUSINESS WIRE)--Vyome Holdings, Inc., ("Vyome") (NASDAQ: HIND), a next-generation inflammation-focused company leveraging the US–India innovation corridor, today announced its financial results and a series of corporate and clinical milestones following its successful listing on Nasdaq. This quarter marks Vyome’s first full reporting period as a newly listed Nasdaq company. Vyome is a clinical-stage, and AI-focused company positioned to accelerate development across immuno-inflammatory and potential orphan indications. "Vyome is targeting one of the biggest challenges in the world today - inflammation. So many of our medical and mental problems are linked to increased inflammation. We are building our business with a laser focus on shareholder value, whether it’s our capital structure, the development of our assets, or looking at AI opportunities," said Krishna Gupta, Chairman of Vyome. "We had a great first quarter as a public company thanks to our unique strengths, including expertise in/access to the US-India innovation corridor. We announced an important interim result for our drug targeting the billion-dollar opportunity in malignant fungating wound (MFW), and it’s just the beginning!" "This quarter marks a defining step forward for Vyome. We executed a highly efficient transition to the public markets, spending less cash than expected in our first quarter as a public company and strengthening our organization while advancing our lead program," noted Venkat Nelabhotla, CEO of Vyome. He further added, "The promising interim Phase 2 results for VT-1953 reinforce the scientific promise of our immuno-inflammation platform. With our disciplined operations, clean capital structure, and world-class team, we are well-positioned to deliver on the milestones ahead and drive long-term value for both shareholders and patients." VT-1953: Highly Encouraging Interim Phase 2 study Readouts The lead program, VT-1953, a topical agent targeting symptoms of putrid smell and pain in malignant fungating wounds (MFW), an inflammatory condition afflicting an estimated one million cancer patients, continued to show strong clinical momentum. Interim Phase 2 Investigator-Initiated Study data demonstrated statistically significant reductions in malodor (P<0.001) — the primary endpoint Patients also reported r...

Investor releaseQuarter not tagged2025-11-04

Vyome Holdings Announces Results of Annual Shareholder Meeting

Business Wire

All 3 Class I directors, formerly at MIT, are re-elected to the board until the 2028 annual meeting CAMBRIDGE, Mass., November 04, 2025--(BUSINESS WIRE)--Vyome Holdings, Inc. ("Vyome") (Nasdaq: HIND) announced it held its annual shareholder meeting on October 28, 2025. All 3 Class I directors up for re-election – Krishna K. Gupta, Shiladitya Sengupta, and Stash Pomichter – were re-elected to serve on Vyome’s board until the 2028 annual shareholder meeting, with 93% of the votes being cast in favor. "This vote of confidence from shareholders ensures that Vyome’s strong, innovative DNA of MIT alums remains intact for years to come. None of the Independent board members is taking any cash compensation or any new equity grants (other than grants that are issuable pursuant to the recent merger transaction), to remain completely aligned with shareholders and value creation," said Krishna Gupta, Chairman of Vyome. The shareholders also ratified the appointment of Kreit & Chiu CPA LLP as Vyome’s independent registered public accounting firm for the fiscal year ending December 31, 2025, as well as voted in the majority to approve the 2025 Equity Incentive Plan and the compensation of the named executive officers. "Our first annual shareholder meeting as HIND was a success in continuing to shape the foundations of what we believe will be a lasting company being architected to be aligned with shareholder interests that are dilution-conscious and cost-efficient strategies," said Venkat Nelabhotla, CEO of Vyome. About Vyome Holdings, Inc.: Vyome is building the world’s premier platform spanning the US-India innovation corridor. Vyome’s immediate focus is leveraging its clinical-stage assets to transform the lives of patients with immuno-inflammatory conditions. By applying groundbreaking science and its unique positioning across the US India innovation corridor, Vyome seeks to deliver lasting value to shareholders in a hyper cost-efficient manner while upholding global standards of quality and safety. To learn more, please visit www.vyometx.com Forward-Looking Statements Certain statements made in this press release are "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as "target," "believe," "expect," "will," "shall...

TranscriptFY2024 Q32024-11-14

FY2024 Q3 earnings call transcript

Earnings source - 17 paragraphs
Operator

Good afternoon, and thank you for joining the ReShape Lifesciences Third Quarter 2024 Conference Call. I would like to turn the call over to Michael Miller from Rx Communications.

Michael Miller

Good afternoon, everyone, and thank you for joining the third quarter 2024 ReShape Lifesciences' earnings call. I'm pleased to be joined today by Paul Hickey, President and Chief Executive Officer; and Tom Stankovich, Chief Financial Officer. Management will also be joined by Krishna Gupta, a current Director of Vyome Therapeutics who will be appointed Chairman of the combined company upon the completion of the previously announced merger agreement between the two companies. As we do each quarter, Paul will provide an overview and update on the company's activities, and Tom will review the financial results for the period, after which, Paul will introduce Krishna for his remarks. As a reminder, this conference call as well as ReShape Lifesciences' SEC filings and website including the Investor information section of the website, contains 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 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 the company's most recent Annual Report on Form 10-K. As an additional reminder, ReShape's stock is listed on NASDAQ trading under the ticker symbol RSLS. I'll now turn the call over to Paul Hickey, President and CEO of ReShape Lifesciences. Paul?

Paul Hickey

Thank you, Mike, and thanks to all of you for joining us this afternoon. As Mike noted, after I provide an overview and update on ReShape's activities and Tom reviews our financial performance Krishna Gupta will take a few moments to share some background on the exciting vision of Vyome Holdings. Let's begin with an overview of our activities during the third quarter and subsequent period. During the quarter, our revenue continues to rebound, increasing 16.6% in the third quarter over the second quarter, the third sequential quarter of revenue growth, and 6.4% over the third quarter of last year. While we remain highly focused on maintaining our disciplined approach to continually leveraging resources in order to execute on our 2024 cost reduction plan which has led to over 40% lower operating expenses for the first nine months of the year compared to last year. As a result, our gross profit margin increased to 62.8% for the quarter and 60.3% for the first nine months. Tom will detail these cost reductions later in this call. In addition to the cost reductions, we continue to fine-tune our lead generation activities and invest in our growth drivers, including the commercial launch of our physician-led redesigned Lap-Band 2.0 FLEX. We completed our early launch phase and our analyzing data and metrics that will be used to support our widespread commercial launch. Additionally, as announced this week, we received approval for the Lap-Band 2.0 FLEX from Health Canada, which represents yet another important growth catalyst for the Lap-Band franchise as we look to gain regulatory approvals worldwide. Also announced this week, we were awarded approximately $241,000 supplementary grant from NIH with the University of Southern California's Center for Autonomic Nerve Recording and Stimulation Systems. This nondilutive supplemental grant awarded over the course of one year, will fund studies to test the safety and efficacy of the next-generation electrodes for ReShape for proprietary Diabetes Bloc-Stim Neuromodulation or DBSN device, which can potentially double the nerve contact area, reduce power consumption and increase the effectiveness of delivering DBSN signals. This fourth grant from the NIH brings our total received awards to $1.15 million, demonstrating the viability of our nondilutive funding strategy, and the NIH keen interest in our novel DBSN technology and potential in the global diabetes market. Most notably, in July, we coordinated both the merger agreement with Vyome Therapeutics and the concurrent asset purchase agreement with Biorad and we successfully negotiated with our Series C shareholders to substantially lower the liquidation preference. All things considered, we feel strongly these concurrent deals will maximize stockholder value and earnings potential. Krishna Gupta will detail the merger with Vyome, a little later in this call, which will shed some light on why we are very bullish on these transactions. Before I do that, I'd like to touch on the obesity market. Obesity is a complex lifelong disease that requires individualized treatment strategies to achieve sustainable weight loss. As most of you are aware, the promotion of GLP-1 receptor agonist has lessened the stigma around obesity and has started to normalize medical intervention and treatment. GLP-1 receptor agonists have provided considerable advantages for individuals with type 2 diabetes and has also benefited individuals dealing with obesity. We continue to believe that the number of people seeking the help of medical professionals especially bariatric surgeons over time will increase. Further, with the health economic cost burden related to widespread adoption of the GLP-1s as well as our low real-world long-term tolerability we believe that the market opportunity for our minimally invasive Lap-Band increase, especially with the newly launched Lap-Band 2.0 FLEX. In the interim, our cost reductions have allowed us to focus and optimize the commercialization of the Lap-Band 2.0 FLEX, which was created to improve the patient experience. As I touched on earlier, we successfully completed the limited market release of the Lap-Band FLEX, and it went exceptionally well. I'm pleased to report that initial surgeon feedback has been very positive. Added to this, our patient-centric website is receiving meaningful traffic, while our co-op marketing programs has proven effective and scalable with key Lap-Band centers nationwide. Now let's talk about the future of ReShape shareholders with Vyome. As most of you know last year, we conducted a high-priority search for synergistic merger and acquisition opportunities. engaging the Maxim Group exclusively to assist in this process. After extensively evaluating multiple strategic options and engaging in discussions with other potential merger and acquisition candidates, our Board of Directors unanimously recommended the merger with Vyome, along with the concurrent asset sale to Biorad. We believe this merger presents a significant opportunity for our shareholders to capitalize on the potential of owning a meaningful portion of Vyome's go-forward business, which encompasses tangible assets and a big vision captured in a newly combined company. As previously reported, Biorad has been granted an exclusive license for our Obalon Gastric Balloon System in the Indian subcontinent. We believe Biorad is the most synergistic partner to purchase our assets, including the Lap-Band system and the Obalon Gastric Balloon System for $5.16 million in cash, this asset purchase agreement will allow us to pay down the costs associated with the Vyome transaction and deliver maximum value to our shareholders. It is also worth noting that in October, we regained compliance with NASDAQ after effecting a 1-for-58 reverse stock split in September, which was a critical component for the merger with Vyome. I remain very excited about the shareholder value and growth potential resulting from these transactions. And I'd now like to turn the call over to Tom Stankovich to provide a recap of our financial performance. Tom?

Thomas Stankovich

Thanks, Paul. And once again, thank you all for joining our webcast this afternoon. As Paul mentioned earlier, during the third quarter, our revenues continue to stabilize and grow and has increased for the third quarter -- third sequential quarter this year. Additionally, and in response to the short-term impact and adoption of GLP-1s, we have reorganized the company and maintained our disciplined approach to executing our cost reduction plan for 2024. With various cost reductions, we have achieved a 41% reduction in overall operating costs for the first nine months of 2024 compared to the same period last year. All expense items within our operating expenses are the same or lower than the comparable period in the prior year. And as a result, we also saw increases in our gross profit margin. A full discussion of our actual financials is in our press release and 10-Q. So I will just take a moment to review key financial metrics for the third quarter and nine months ended September 30, 2024. Our revenue totaled $2.3 million for the three months ended September 30, 2024, an increase of 6% or $100,000 compared to the same period in 2023. This primarily resulted from an increase in sales volume, offset by continued pressure primarily due to GLP-1 pharmaceutical weight loss alternatives. Quarterly revenue was 17% higher or $300,000 compared to the second quarter of 2024. Revenue totaled $6.2 million for the nine months ended September 30, 2024, a contraction of 7% or $500,000 compared to the same period in 2023. This primarily resulted from a decrease in sales volume, primarily due to GLP-1 pharmaceutical weight loss alternatives. Gross profit for the three months ended September 30, 2024, was $1.4 million, which was slightly above $1.3 million for the same period in 2023. Gross profit as a percentage of total revenue for the three months ended September 30, 2024, was 63% compared to 60% for the same period in 2023. Gross profit for the nine months ended September 30, 2024 and 2023 was unchanged at $3.7 million. Gross profit as a total -- as a percentage of total revenue for the nine months ended September 30, 2024, was 60% compared to 55% for the same period in 2023. The increase in gross profit margin is due to the reduction of overhead-related costs, primarily in payroll as the company has had a reduction of employees late in 2023. Sales and marketing expenses for the three months ended September 30, 2024, decreased by $1.1 million or 60% to $700,000 compared to $1.8 million for the same period in 2023. Sales and marketing expenses for the nine months ended September 30, 2024, decreased by $3.7 million or 61% to $2.4 million compared to $6.2 million for the same period in 2023, the decrease is primarily due to a decrease in advertising and marketing expenses, including consulting and professional marketing services as the company has reevaluated its marketing approach and has moved to a targeted digital marketing campaign, resulting in a reduction of costs. Additionally, there was a decrease in payroll-related expenditures including commissions, stock-based compensation expense and travel. General administrative expenses for the three months ended September 30, 2024, increased slightly by $45,000 or 1% to approximately $2.1 million compared to the same amount $2.1 million for the same period in 2023. The nominal increase is primarily due to an increase in professional services, primarily related to the merger and asset purchase transaction that was entered into in July 2024, offset by reductions in employee-related expenses and bad debt expense. General and administrative expenses for the nine months ended September 30, 2024, and decreased approximately $2.7 million or 30% to $6.1 million compared to $8.7 million for the same period in 2023. The decrease is primarily due to a reduction in professional services such as audit and legal fees of $1.1 million, primarily due to the company incurring onetime adjustments for professional services related to our February 2023 public offering. A reduction in payroll-related expenses, including stock-based compensation expense due to a decline in staffing levels, a reduction in rent expense as the company moved its headquarters at the end of the second quarter of 2023 to a smaller facility to reduce costs and a reduction in bad debt expense. Research and development expenses for the three months ended September 30, 2024, decreased by $100,000 or 26% to $400,000 compared to $500,000 for the same period in the prior year. Research and development expenses for the nine months ended September 30, 2024, decreased by $300,000 or 19% to $1.3 million to approximately $1.6 million for the same period in the prior year. The primary reason for the reduction -- a decrease in the reduction is payroll, consulting and clinical trials. Non-GAAP adjusted EBITDA was $1.6 million for the three months ended September 30, 2024, compared to a loss of $2.9 million in the same period last year, an improvement of $1.2 million, for the nine months ended September 30, 2024, the adjusted EBITDA loss was $5.6 million as compared to $12 million for the same period last year, an improvement of $6.4 million. Both reductions are primarily due to our continued efforts to reduce overall operating costs. We ended the quarter with net working capital of $1.3 million, including cash and cash equivalents and restricted cash of $800,000. And now with that, I'll turn the call back over to Paul.

Paul Hickey

Thanks, Tom. While I'm happy to be joined once again by Krishna Gupta, who will be the Chairman of the combined company post-merger to further outline Vyome strategy and vision for the future. Now over the last year, I've had the pleasure of working with Krishna, and I am truthfully very excited about the opportunity for our ReShape shareholders and new shareholders alike to become part of Vyome that stands apart from any other investment opportunity. Krishna?

Krishna Gupta

Thanks, Paul and Tom. I'd like to take this opportunity to kick off a more meaningful dialogue with ReShape's shareholders. I'm looking forward to having you along on the Vyome journey, which also revolves around innovation in healthcare, much as ReShape has done. We'll be putting out a deck on the Vyome vision shortly, but in the interim, I encourage you all to read through the S-4, which is publicly filed and available. We note in the S-4 that both sides have valued the go-forward entity at about $130 million for the purposes of allocating the ownership of the combined company between ReShape and Vyome current shareholders, underpinned by our existing assets. We view this transaction as a massively positive one for ReShape shareholders and believe there is significant upside beyond this valuation as well if the Vyome team executes well in 2025. So what does Vyome do? As a reminder, Cambridge, Massachusetts-based Vyome is an innovation-driven healthcare platform centered around the U.S. India corridor and the increasingly special relationship between the two countries. In particular, we are building a healthcare platform that we anticipate having three core pillars underpinning the bridge between U.S. and India. Number one, biopharma, where we already have developed valuable assets; number two, medical devices; and number three, AI. The latter 2, we are in the process of building the foundations for. We intend to be very active deal makers as a core competency in order to potentially further our platform and shareholder value. As an example of this, we have struck multiple deals with Sun Pharma, the fourth largest global specialty generic pharma company to commercialize some of Vyome technology in India. We'll be sharing more information and upcoming milestones about our core assets and how we think about value in our investor presentation shortly. These core assets have been developed over nearly a decade with millions of dollars invested significant IP filed around the world and a large value creation opportunity centered on the large immuno-inflammation space, which has seen several lucrative deals. We've been very tactical about designing assets for rare unmet needs, accelerating development and hopefully one day monetization. I encourage you to understand our assets in some detail. I also want to shed some light on our Board and my colleagues who are one of the world's best group of individuals to be stewarding this vision. Every person on our Board is educated at the world's top institutions is equally comfortable in the U.S. and in India and has developed or invested in innovation on both sides of this bridge. Whether it is Co-founder, Shiladitya Sengupta, who was Gold Medalist of India's top Medical University and now is a researcher at MIT and Harvard or Ambassador Frank Wisner, who was U.S. Ambassador to India, New York to New Delhi is a route we know extremely well. By putting our stake in the ground and capitalizing on the number one public market in the world for innovation-driven companies, the NASDAQ, we are excited about taking this journey with all of you. We believe the election results to be a strong tailwind for Vyome vision, which is synergistic with our M&A strategy. We expect both the capital markets, including the Indian American hedge fund managers on Wall Street and retail shareholders alike to recognize a significant opportunity that exists by engaging with India as its influence on healthcare is beginning to resemble the trajectory shown in technology. In closing, we are confident in our ability to potentially build significant value with our pipeline of novel local agent drugs for significant unmet needs, supported by a robust patent portfolio effective drug development strategies, a balance sheet with no debt and prudent capital deployment toward a really big vision that is propelled by macro tailwinds and near-term catalysts. Our Board and in Vyome are 100% focused on creating shareholder value for you and Vyome investors. If you're excited about healthcare innovation about the exchange of talent, ideas and capital between the U.S. and India, and about the value creation opportunity that this transaction may offer you, please join us. With that, I'd like to turn the call back to Paul.

Paul Hickey

Thanks, Krishna. You just shared a very compelling and believable opportunity that shareholders can be a part of with their approval of the proposed merger and asset purchase agreement. To remind shareholders, the details shared by Krishna are outlined in the S-4 registration statement which includes the proxy statement. When the SEC declares the S-4 effective, we will plan and hold a shareholder meeting to approve the transactions. Krishna's message should excite you, and it is part of the reason our Board unanimously recommended the merger with Vyome and the concurrent set sale to Biorad. Thank you again, Krishna. I'm grateful for you joining today's call to discuss what future shareholders can anticipate with Vyome Therapeutics. They'll be in great hands. Additionally, I want to express my sincere appreciation to our employees, Board members, customers, consultant advisers, suppliers and existing and new shareholders for your unwavering support of ReShape and support for our future as Vyome Therapeutics. Thank you all.

Operator

Before we conclude, we have one question from Jason McCarthy from Maxim Group. Mr. McCarthy, your line is open.

Jason McCarthy

Hi guys. Hello. I'm sorry. Can you guys -- as we start to think about Vyome, a bit more from a pharmaceutical biotech company. Can you just talk at a high level about the 1953 gel kind of what it does and your plans to target malignant fungating wounds, something I think a lot of people don't really know too much about and it would be a good opportunity maybe to inform some of the investors here.

Paul Hickey

That is definitely in Krishna's warehouse. Krishna?

Krishna Gupta

Yes. The malignant fungating wounds is an example of a rare unmet disease. I'm going to defer on talking about the science until we put out our investor deck. But what I can point you to is that, it's an example of an immuno inflammation therapy. So if you look at the world today, it's beset by many problems that are frankly niche untreated and often caused by an underlying immuno inflammation response. It's a category that's hot. And Vyome's scientific journey has always been focused on identifying the root cause and treating them from the lens of how do we interact with the immune system of the body. So malignant fungating wounds is one of these examples where patients that suffer from this, have quite acute symptoms that are multisensory. Obviously, it's painful, but then there's a very strong smell and it is a very, very disturbing site to look at as well. And that can cause significant damage to people's quality of life. And we believe we are working on, the only sort of solution and sort of product that can treat this in a systemic way. And we believe that can create a lot of value for shareholders to come. And that's just one example of where we can use this sort of development philosophy of, hey, how can we use existing molecules, target them towards rare unmet needs and do so in spaces where the underlying causes are immuno inflammatory. I'd love to share more, but I want to wait until we put out our investor presentation.

Jason McCarthy

Okay. Well, that presentation have, I guess, a high-level outline of the strategy in terms of what programs to take forward, whether it's the 1953, or the 1908 and the uveitis indication, which a lot of the ophthalmology space has been very, very busy over the last 12 to 24 months. Is that a fair assessment of what we could expect?

Krishna Gupta

Yes. Yes, you will have -- we will sort of share a bit about the three different molecules that we have, the catalysts that we are intending to pursue in the near term and the value unlocks would follow.

Jason McCarthy

Okay. And just a quick one back to the ReShape Group. You had mentioned that the GLP-1 agonist and dual agonists that are out there pressured your platform. Do you think that there's going to be more gravitation just in general, over time towards Lap-Band, things like that as opposed to GLP-1s as people kind of break that stigma of obesity, as you mentioned, do you think there's an opportunity after that market will expand or rebound, I guess, maybe be the right way to phrase it.

Paul Hickey

Yes. I do. It's a great question. I was just at ASMBS weekend conference in Atlanta last weekend. and sort of talked about the market overall and adoption of GLP-1s and what the impact has been on bariatric surgeries done in the U.S. and clearly, there's been an impact. And so again, our gains this quarter and through the year have sort of been -- and to me signaling their sort of market gains, based on the fact that we've got more people that are getting into these obesity discussions kind of petering out or tapering on the weight loss they get with GLP-1s or other means and looking for the least invasive option. Now it's interesting that the obesity market overall is clearly untapped. Even with GLP-1s, I think they showed data, whether it's accurate or not to be -- not more than roughly about 10% adoption of that 100% of the pie that is obese -- clinically obese and needs to get medical attention. So it's still primarily an underserved market, and that's where it's going to take time for sort of societal influence as well as big pharma to help give people off the sidelines and then to physicians to start talking about improving their quality of life.

Jason McCarthy

Got it. Thanks guys for taking the questions.

Operator

Thank you. Ladies and gentlemen, this does conclude the conference. The conference has now concluded. Thank you for attending today's call. You may now disconnect.

TranscriptFY2024 Q22024-08-15

FY2024 Q2 earnings call transcript

Earnings source - 8 paragraphs
Operator

Good day, and thank you for standing by. Welcome to the ReShape Lifesciences Second Quarter 2024 Earnings Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Michael Miller, Rx Communications. Please go ahead.

Michael Miller

Good afternoon, and thank you for joining the second quarter 2024 ReShape Life Sciences earnings call. I'm pleased to be joined today by Paul Hickey, President and Chief Executive Officer; and Tom Stankovich, Chief Financial Officer. Management will also be joined by Krishna Gupta, a current Director of Vyome Therapeutics, who will be appointed Chairman of the combined company upon the completion of the previously announced merger agreement between the two companies. As we do each quarter, Paul will provide an overview and update on the company's activities, and Tom will review the financial results for the period, after which Paul will introduce Krishna for his remarks. As a reminder, this conference call as well as ReShape Lifesciences' SEC filings and website, including the Investor Information section of the website contains 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 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 the company's most recent annual report on Form 10-K. As an additional reminder, ReShape stock is listed on NASDAQ, trading under the ticker symbol RSLS. I'll now turn the call over to Paul Hickey, President and CEO of ReShape Lifesciences. Paul?

Paul Hickey

Thank you, Mike, and thanks to all of you for joining us this afternoon for our earnings call for the second quarter of 2024. As Mike noted, after I provide an overview and update on ReShape's activities and Tom reviews the financial performance, Krishna Gupta will take a few moments to share some background and outline the strategy and vision of the NewCo to be called Vyome Holdings, following the closing of our announced merger agreement. Let's begin with an overview of our activities during the second quarter and subsequent period. We've remained laser-focused on stabilizing revenues and maintaining our disciplined approach to continually leveraging resources in order to execute on our 2024 cost reduction plan, which has led to approximately 45% lower operating expenses for the first half of the year compared to last year. As a result, we have stabilized our gross profit margin even with lower sales resulting from the widespread adoption of GLP-1s. Tom will detail these cost reductions later in this call. In addition to these reductions, we continue to fine tune our lead-generation activities and invest in our growth drivers, including the commercial launch of our physician-led redesigned LAP-Band 2.0 Flex. We are currently in the last phase of our limited market release and gathering data and metrics that will be used to support an anticipated widespread commercial launch. Most notably, in July, we coordinated both the merger agreement with Vyome Therapeutics and the concurrent asset purchase agreement with Biorad as well as successfully negotiated with our Series C shareholders to substantially lower their liquidation preference. All things considered, we feel we are successfully maximizing stockholder value and earnings potential. I will detail the transaction a little bit later in this call. Before I do that, I'd like to touch on the obesity market. Obesity is a complex, lifelong disease that requires individualized treatment strategies to achieve sustainable weight loss. GLP-1 receptor agonists have provided considerable advantages for individuals with type 2 diabetes and has also benefited individuals dealing with obesity. However, real-world, long-term tolerability for GLP-1s is low. And based on this evidence, we believe that the market opportunity for the LAP-Band will increase over time, especially with the newly launched next-generation LAP-Band 2.0 FLEX. As most of you are aware, the stigma around obesity and medical intervention has been normalized by the adoption of GLP-1 receptor agonist usage. And we continue to believe that the number of people seeking the help of medical professionals, especially bariatric surgeons over time will increase. In the interim, our cost reductions have allowed us to focus on and optimize the commercialization of our LAP-Band 2.0 FLEX, which was created to improve the patient experience while continuing to market our current LAP-Band. The limited market release of the LAP-Band 2.0 FLEX is nearing completion and is going exceptionally well, and initial surgeon feedback has been very positive. Added to this, our patient friendly website is receiving meaningful traffic, while our co-op marketing program has proven effective and scalable with key LAP-Band centers. As it relates to the recent merger agreement, as most of you know, beginning in December of last year, we conducted a high-priority search for synergistic merger and acquisition opportunities having engaged Maxim Group LLC on an exclusive basis to assist in this process. To that end, following an extensive evaluation of multiple strategic options and engaging discussions with a number of other potential merger and acquisition candidates, our Board of Directors unanimously recommended the merger with Vyome along with the concurrent asset sale to Biorad. We believe this presents a significant opportunity for our shareholders to capitalize on the potential of the newly formed entity post-merger. As previously reported, Biorad has an exclusive license for our Obalon Gastric Balloon System. We believe they are the most synergistic partner to sell our assets to, including our LAP-Band system, Obalon Gastric Balloon System and the Diabetes Bloc-Stim Neuromodulation system. This asset purchase agreement for $5.16 million in cash will allow us to pay down the costs associated with the Vyome transaction. Notably, our disciplined cost reduction plan facilitated the value we are able to bring to our shareholders. Additionally, I would like to express our gratitude to our Series C preferred stockholders for their willingness to substantially lower their liquidation preference, thereby enabling our common stockholders to recognize the potential value of the merger. Krishna will detail more information on the Vyome transaction later on this call. I'm very excited about the shareholder value and growth potential resulting from these transactions. I'd now like to turn the call over to Tom Stankovich to provide a recap of our financial performance. Tom?

Thomas Stankovich

Thanks, Paul. And once again, thank you all for joining our webcast this afternoon. As Paul mentioned earlier, in response to the short-term impact and adoption of GLP-1s, we have reorganized the company and maintained our disciplined approach on executing our cost reduction plan for 2024. With various cost reductions, we have achieved a 45% reduction in overall operating costs for the first six months of 2024 compared to the same period last year. All expense line items within our operating expenses are lower than the comparable period in the prior year. Additionally, we have stabilized and increased our gross profit margins even with the lower sales due to the adoption of GLP-1s. A full discussion of our financials is available in our press release and 10-Q. I will just take a few moments to review key financial metrics for the second quarter and six months ended June 30, 2024. Our revenue totaled $2 million for the three months ended June 30, 2024, which represents a reduction of $300,000 compared to the same period in 2023. Revenue totaled $3.9 million for the six months ended June 30, 2024, and represents a reduction of $600,000 compared to the same period in 2023. The reason is due to a decrease in sales volume, which is primarily due to GLP-1 pharmaceuticals. Gross profit for the three months ended June 30, 2024, was $1.1 million and was slightly below $1.2 million for the same period in 2023. The gross profit as a percentage of total revenue for the three months ended June 30, 2024, increased to 58% compared to 53% for the same period in 2023. Gross profit for the six months ended June 30, 2024, and 2023 was $2.3 million and $2.4 million, respectively. Gross profit as a percentage of total revenue for the six months ended June 30, 2024, increased to 59% compared to 53% for the same period in 2023. The increase in gross margin, gross profit percentage is due to the reduction in overhead related costs, primarily payroll as the company had a reduction in employees late in 2023. Sales and marketing expenses for the three months ended June 30, 2024, decreased by $1.5 million to $700,000 compared to $2.2 million for the same period in 2023. Sales and marketing expenses for the six months ended June 30, 2024 decreased by $2.7 million or $1.7 million compared to $4.4 million for the same period in 2023. The decreases in the 3- and 6-month periods ended were primarily attributable to a decrease in advertising and marketing spending, including consulting and professional marketing services as the company reevaluated its marketing approach and has moved to a targeted digital marketing campaign, resulting in a reduction of costs. Additionally, there were reductions in sales personnel and related reductions in payroll-related expenditures, including commissions and travel. General and administrative expenses for the three months ended June 30, 2024, decreased by $300,000 to approximately $2.1 million compared to $2.4 million for the same period in 2023. General and administrative expenses for the six months ended June 30, 2024, decreased by $2.7 million to approximately $4 million compared to $6.7 million in the same period in 2023. The decrease for both three and six months of 2024 is due to a reduction in payroll-related expenditures, a decline in staffing levels and a reduction in rent expense as the company moved its headquarters at the end of the second quarter of 2023 to a smaller facility to reduce costs and professional fees. Research and development expenses for the three months ended June 30, 2024, decreased by $200,000 to $400,000 compared to $600,000 for the same period in the prior year. Research and development expenses for the six months ended June 30, 2024, decreased by $200,000 to $900,000 compared to approximately $1 million for the same period in the prior year. The primary reason for the decrease is due to a reduction in consulting and clinical trials as the company has paused clinical trial work to preserve cash. Non-GAAP adjusted EBITDA loss was $1.9 million for the three months ended June 30, 2024, compared to a loss of $3.7 million in the same period last year. For the six months ended June 30, 2024, the adjusted EBITDA loss was $4.1 million as compared to $9.1 million in the same period last year. Both reductions are primarily due to our continued efforts to reduce overall costs. We ended the quarter with net working capital of approximately $2.9 million, primarily due to cash and cash equivalents, including restricted cash totaling $1.2 million, and we remain debt free on our balance sheet. With that, I will now turn the call back over to Paul.

Paul Hickey

Thanks, Tom. At this time, I'm excited to have the opportunity to introduce Krishna Gupta, who will be the Chairman of the combined company post-merger to outline Vyome strategy and vision for the future. Krishna?

Krishna Gupta

Thanks, Paul, and I'm really excited to be here to speak with the shareholders of this great company. I appreciate the opportunity to talk about the exciting work we're doing in Vyome Therapeutics. We're a clinical-stage company focused on treating immuno-inflammatory diseases of unmet needs with next-generation solutions. Upon closing of this merger agreement, we will rename the company Vyome Holdings, Inc. to reflect our approach to building multiple accretive assets under the Vyome umbrella. The former ReShape stock will continue to be listed on the NASDAQ market under the new ticker symbol HIND, an ancient name for India, which is an integral part of Vyome's identity and competitive advantage. The Vyome team is a great balance of scientific prowess, big-picture vision, execution, experience and capital markets agility. I want to call attention to our scientific founder, Shiladitya Sengupta, a top student at India's best Medical School, an alumni of Cambridge and MIT. He's been a researcher at MIT and Harvard for years and has been a friend of mine for over a decade. We're a clinical stage company, laser-focused on identifying unmet medical needs and addressing them with novel approaches and smart clinical trial designs. We've very thoughtfully been building in the immuno-inflammation sector, which is a hot and expanding area, and we have a very promising pipeline developed over the past few years with potential, near-term catalysts treating rare and unmet diseases. If we zoom out, our current assets reflect some of our key competitive advantages. We're accessing world-class talent and world-class research at much lower cost, thanks to our proprietary connections to India, all in order to solve tangible, real-world problems with large U.S. market opportunities. This is an extremely timely generational opportunity. India is the biggest growth story in the world, especially as China's growth declined. We all know about the success of the Indian IT sector and the numerous successful Indian software founders and executives both in the U.S. and India. This theme is becoming increasingly tangible with healthcare as well. I'm very bullish on our ability to bring in additional opportunities, partnerships and acquisitions under the Vyome Holdings umbrella, deals that enable our future shareholders to access the special and growing innovation connection between the U.S. and India. From the onset, Vyome will be well positioned for success in the public markets, having proactively insured, have no debt, a clean capital structure and a very aligned board. As part of the execution of the merger agreement, we have commitments for additional capital, anchored in part by Dr. Ranjan Pai, Chairman of the Manipal Education and Medical Group and investors affiliated with Remus Capital and Iron Pillar. Certain of Vyome's current stockholders have committed to a minimum $7.3 million private placement in the combined company and its subsidiaries, which may be upsized through additional investments to close concurrently with the merger. Based on our anticipated cash flow projections, we should have adequate liquidity on hand to self-fund into the second half of '25. We plan to deploy the capital raised through the private placement to unlock significant value in our pipeline of immuno-inflammatory assets. Let me reiterate, we strongly believe that India is the world's greatest growth story, and we also believe that immuno-inflammation offers a significant opportunities for value creation. As such, we are excited about using our new public platform to strengthen our existing assets and unlock key value milestones from our pipeline, leveraging the world-class Indian innovation corridor and the U.S. market. We are confident in our ability to potentially build significant value with our pipeline of novel, local agent drugs for significant unmet needs, supported by a robust patent portfolio, effective drug development strategies, a balance sheet with no debt and prudent capital deployment, all with a focus on accreting value for shareholders. So in closing, we feel like we are very aligned with ReShape's shareholder expectations for a disciplined and focused business model executed flawlessly to help ensure we maximize shareholder value. Thank you in advance for your support and vote for this merger agreement. I'm excited to call all of you our shareholders. We look forward to providing you with updates on Vyome Holdings in the future, and I want to wish India a happy Independence Day. With that, I would like to turn the call back to Paul.

Paul Hickey

Thanks, Krishna. We are generally enthusiastic about the benefits we are poised to deliver to our shareholders as a result of the merger and asset purchase agreement, which will be described in more detail in an S-4 registration statement. That will include the proxy statement related to the merger and asset purchase agreement, followed by a holding of a shareholder meeting for the approval of the transactions. I'd also like to reiterate that our Board of Directors unanimously recommended the merger with Vyome along with the concurrent asset sale to Biorad. I'd like to express my gratitude again to Krishna for joining the call today to discuss the exciting prospects for Vyome Therapeutics. And as always, I want to thank our employees [technical difficulty]

Operator

Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.

TranscriptFY2024 Q12024-05-15

FY2024 Q1 earnings call transcript

Earnings source - 8 paragraphs
Operator

Good afternoon, and thank you for joining the ReShape Lifesciences First Quarter 2024 Conference Call. I would like to turn the call over to Michael Miller from Rx Communications.

Michael Miller

Good afternoon, and thank you for joining the First Quarter 2024 ReShape Lifesciences Earnings Call. I'm pleased to be joined today by Paul Hickey, President and Chief Executive Officer; and Tom Stankovich, Chief Financial Officer. Paul will provide an overview and update on the company's activities, and Tom will review the financial results for the period. We will then turn the call back over to Paul for some closing remarks, after which, we will open up the call to a question-and-answer session. As a reminder, this conference call as well as ReShape Lifesciences' SEC filings, and website including the investor information section of the website, contains 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 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 the company's most recent annual report on Form 10-K. As an additional reminder, ReShape stock is listed on NASDAQ, trading under the symbol RSLS. I will now turn the call over to Paul Hickey, President and CEO of ReShape Lifesciences. Paul?

Paul Hickey

Thank you, Mike, and thanks to all of you for joining us this afternoon for our earnings call for the first quarter of 2024. During the first quarter and subsequently, we have remained focused on delivering shareholder value and have reshaped on a path to profitability and long-term sustainability. Key to our success include our efforts to stabilize revenues as well as our disciplined approach to continually leveraging resources and focus on reducing costs as we outlined in March. To that end, we continue to fine-tune our lead generation activities and invest in our growth drivers, including the commercial launch of our physician-led redesigned Lap-Band 2.0 FLEX. At the same time, we continue our high-priority search for strategic and synergistic M&A opportunities. As we have mentioned before, we have engaged the Maxim Group on an exclusive basis to assist in this process. As one can imagine, we've had a high level of activity, and we'll continue this effort to find the right partner to join us in our mission at ReShape to improve the quality-of-life for individuals fighting obesity worldwide. With the stigma around obesity and medical intervention being normalized by the surge of GLP-1 receptor agonist usage, we are steadfast in our confidence that the numbers of people seeking medical professionals, especially bariatric surgeons will continue to increase. The GLP-1's short-term impact on the market last year made it necessary for us to undertake additional strategic cost reductions, including a further reduction in staff, leading to a projected 55.4% decrease in operating expenses for 2024 as compared to last year. Tom and I will provide further details during this call. but this reorganization and decrease in expenses will allow us to focus on and optimize the commercialization of our Lap-Band 2.0 FLEX created to improve the patient experience while continuing to market our current Lap-Band 2.0. Now I'm happy to report that the limited launch of the Lap-Band 2.0 FLEX continues to progress well, and the initial surgeon feedback has been positive. Added to this, our revamped patient-friendly website is receiving meaningful traffic, while our co-op marketing program involving cost sharing with key Lap-Band centers has proved effective and scalable. Before we cap our first quarter and subsequent highlights, I'd like to remind listeners about the important events occurring within the obesity market today. As most of you already understand, the global obesity market is growing at an alarming rate and carries with it significant medical repercussions and associated economic costs. Obesity remains a complex lifelong disease that requires personalized treatment to ensure long-term weight loss goals are achieved. I'm sure you're also aware of the growing population of GLP-1 receptor agonists that have brought significant benefits to those suffering from type 2 diabetes and that help those who have obesity. We believe that GLP-1 adoption is expanding the medical weight loss market by vastly reducing the stigma that often occurs around obesity and medical intervention, including bariatric surgery. However, it's becoming very clear that weight loss due to GLP-1 drug usage has limitations, especially related to cost, accessibility, and the fact that weight loss plateaus by 12 to 18 months. Additionally, the real-world long-term tolerability is low. In one large analysis, only 27% of patients prescribed GLP-1 receptor agonists were adherent after 1 year. We continue to believe, based on this and other evidence that the market opportunity for the Lap-Band will increase over time, especially with the newly launched next-generation Lap-Band 2.0 FLEX. From a continuum of care perspective, individuals with obesity on GLP-1 therapy are likely potential candidates for Lap-Band bariatric surgery as the next viable anatomies preserving weight loss treatment. In other words, once GLP-1 patients get a taste of weight loss, you have issues with the drug's accessibility, durability or tolerance, they will contemplate bariatric surgery, especially minimally-invasive procedure like the Lap-Band. Furthermore, as the safest and only adjustable and reversible bariatric surgery, the Lap-Band is ideal for simple specific types of patients, like women and childbearing years who are not able to utilize GLP-1 drugs. Now let me take a few minutes to update you on our progress related to our primary growth pillars. As I mentioned earlier in the call, I want to provide more specifics on the progress made toward our first pillar to deliver shareholder value, and ultimately, profitability. Specifically, as we consider the impact of GLP-1 receptor agonist prescriptions for weight loss treatment, which has put pressure on the bariatric industry, it was imperative to conduct a thorough evaluation of our operations, and swiftly implement substantial cost-cutting measures. At the same time, we were channeling investments into the most promising part of our strategy to drive growth and maintain adherence to critical P&L metrics within our organization. Now Tom will detail the expense savings we have identified realized in our planning for. In summary, we have identified and implemented additional cost reductions expected to result in lower operating expenses of approximately $8 million in 2024, a more than 50% reduction over 2023, excluding onetime costs. We are optimizing our marketing spending while making additional reductions in consulting services totaling approximately $2.4 million. We have also executed a reduction in force equating to approximately $1.2 million. We've decided to temporarily pause our ReShape Care program and achieve estimated savings of $0.8 million while we work to augment the ReShape Care platform and secure a self-insured employer to provide ReShape Care of employees. We have also planned for $0.9 million of reductions for incentive compensation and other pay-related amounts, all a part of streamlining our team significantly but without affecting revenue. Taken together, these reductions will allow us to focus and invest in our growth drivers while at the same time, extend our cash runway. These changes are bold, necessary and indicative of our commitment to our first pillar, which I established in late 2022. In point of fact, with these 2024 reductions, the company's core operating expenses reduced between 2022 and 2024, an estimated $24 million or 75%. In addition to the necessary cost reduction initiatives related to our first growth pillar, we are continuing to make progress with our cost-effective digital lead generation and patient engagement campaign through our partnership with Hive Medical. This platform allows us to access advanced lead optimization software that enhances patient engagement and increases patient volume. The software utilizes AI SMS platform technology, along with our direct-to-consumer marketing campaign to help individuals easily book appointments with medical professionals. This has led to an increase in the quality of patient needs and cost reduction in targeted markets. Let's now discuss our progress executing our second growth pillar to expand our portfolio and distribution. In February, the first surgeries using ReShape's enhanced Lap-Band 2.0 FLEX were successfully performed. Since then, additional surgeries have taken place and the initial limited launch has gained momentum. This launch represents a significant advancement in improving the overall experience for Lap-Band patients. While we're not only approved to market in the U.S., we are working to obtain regulatory approvals in both Canada and the EU. The new FLEX technology serves as a relief out, alleviating this comfort caused by swallowing large pieces of food and designed to eliminate the need for in-office band emergent adjustments as the band temporarily relaxes before returning to its original diameter. Now earlier this year, we had the opportunity to train surgical fellows on the Lap-Band, and we also introduced them to the Lap-Band 2.0 FLEX. This was an exciting event because the future of Lap-Band relies on its continued adoption by surgeons and surgical fellows who are the next generation of bariatric surgeons. Based on feedback from current surgeons, including those who have already used the Lap-Band 2.0 FLEX. We believe that the new Flex technology will enable us to engage more surgeons and attract new and existing Lap-Band patients. In June, in San Diego at this year's American Society for Metabolic & Bariatric Surgery meeting, or the ASMBS meeting, we are excited to showcase the FLEX technology to the largest gathering of surgeons and integrated health professionals. All combined, we feel there is momentum building and increasing demand for Lap-Band 2.0 FLEX surgery. Making it a true catalyst for growth in Lap-Band franchise and the company as a whole. Now it's also important to note that in March, we significantly strengthened ReShape's intellectual property portfolio surrounding the intragastric balloon system. Having received a Notice of Allowance from the U.S. Patent office and Trademark Office, and in last week had the patent issue. We will continue to build a defensive moat around our product portfolio, innovation and commercialization efforts and take offensive action to defend our position, utilizing nondilutive funding. Before I turn the call over to Tom, I want to reiterate that we remain confident that with our Lap-Band 2.0 FLEX, and legacy Lap-Band, we are uniquely positioned with the safest and most durable organ-sparing and reversible weight loss option for those patients that have historically had an aversion to medically managed weight loss and surgery. Given the growing body of evidence pointing to the fact that weight loss due to GLP-1 receptor agonist usage has limitations related to comorbidities and accessibility, we believe that the market opportunity for the Lap-Band 2.0 FLEX and Lap-Band increase over time. From a continuum of care perspective, these patients are likely potential candidates for bariatric surgery as the next viable weight-loss treatment. I'd like to now turn the call over to Tom Stankovich to provide a recap of our financial performance. Tom?

Thomas Stankovich

Thanks, Paul. And once again, thank you all for joining our webcast this afternoon. As Paul mentioned earlier, we provided an update in March that in response to the short-term impact and adoption of GLP-1s, we have reorganized the company and have identified cost reductions of approximately $8 million or 55% for 2024 alone. Specifically, a reduction in force of approximately $1.2 million, which began in November and December of 2023 and $900,000 of reductions in incentive compensation and other payroll-related amounts have been implemented across all expense categories. Other core operating costs in total have been reduced, which includes reductions in selling and marketing costs of $2.4 million without affecting our continued marketing spend optimization, costs related to the pause of our ReShape Care program totaling $800,000. Expenses related to G&A totaling $1.3 million, primarily in professional, consulting fees and insurance costs. And R&D expenses of approximately $900,000, would primarily include reduced patent fees and consulting costs. Taken together with actions thus far, we have made significant progress reducing our core operating expenses, cutting approximately $24 million or 75% between 2022 and 2024. In fact, during the first quarter of this year, we had a significant reduction in overall operating expenses of 51% compared to the first quarter of 2023. A full discussion of our actual financials is available in today's press release and 10-Q. I will just take a moment to review key financial metrics for the first quarter ended March 31, 2024. Our revenue totaled $1.9 million for the 3 months ended March 31, 2024, which represents a contraction of 15% or $300,000 compared to the same period in 2023. The primary reason is a decrease in sales volume, primarily due to GLP-1 drugs. We continue to focus our new marketing strategy through targeted and AI-supported digital media campaigns near bariatric surgical centers around the U.S. while reducing costs and increasing our efficiencies. We expect that these efforts will continue to come to fruition throughout 2024. Additionally, we anticipate the full U.S. launch of the Lap-Band 2.0 FLEX in 2024 that should contribute to increased sales going forward during 2024 and into 2025. Gross profit for both the 3 months ended March 31, 2024, and 2023 was $1.2 million. Gross profit as a percentage of total revenue for the 3 months ended March 31, 2024, was 60% compared to 54% for the same period in 2023. The increase in gross profit percentage was due to the reduction in overhead-related costs, primarily payroll as the company had a reduction of employees late in 2023. Sales and marketing expenses for the 3 months ended March 31, 2024, decreased by $1.2 million or 53% to $1 million compared to $2.2 million for the same period in 2023. There was a decrease of $700,000 in advertising and marketing expenses as we reevaluated our marketing approach and have moved to a targeted and AI-supported direct digital marketing campaign. There were also 500,000 reductions in payroll-related expenditures, including commissions, stock compensation expense, and travel of $500,000 due to changes in sales personnel and lower sales. General and administrative expenses for the 3 months ended March 31, 2024, decreased by $2.3 million or 56% to approximately $1.9 million compared to $4.2 million for the same period in 2023. The decrease is primarily due to a reduction in professional services such as audit and legal fees of $1.3 million, primarily due to the fiscal year 2022 restatement that occurred during the first quarter of 2023. Public stock offering costs and a reduction in payroll-related expenses, including a reduction in stock-based compensation of approximately $500,000 due to changes within personnel. The company also had a decrease in rent and insurance of $100,000 has it moved to its headquarters during the second quarter of 2023 to a smaller facility to reduce costs. Research and development expenses were $500,000 for the 3 months ended March 31, 2024, remaining consistent with the same period in 2023, with a slight decrease primarily in stock-based compensation. Non-GAAP adjusted EBITDA loss was $2.1 million for the 3 months ended March 31, 2024, compared to a loss of $5.3 million for the same period last year, a reduction of $3.2 million, primarily due to our continued efforts to reduce overall operating costs. We ended the quarter with a net working capital of approximately $4.4 million, primarily due to cash and cash equivalents of $2.5 million and $1.6 million of accounts receivable and remain debt free on our balance sheet. For the remainder of 2024, we anticipate our revenue is increasing and a continued reduction in our operating expenses. With that, I will now turn the call back over to Paul.

Paul Hickey

Thanks, Tom. Before we open the call for Q&A, it is important to reiterate, as both Tom and I have detailed that we have and will continue to significantly reduce operating expenses across all categories so we can invest in our growth initiatives, including the full launch of our Lap-Band 2.0 FLEX. The swift and bold steps we have taken to restructure the company will help to ensure sustainability and scalability. We continue to prioritize investments, including marketing automation to support scalable lead acquisition, segmented consumer-centric messaging being an updated website for improved patient engagement and a frictionless appointment scheduling system with qualified providers while further reducing lead generation costs. Taken together, we expect to increase Lap-Band procedures and ultimately revenue. We will continue to work with the Maxim Group and aggressively search and evaluate our M&A opportunities with intentions of expanding our portfolio that is differentiated from the competition with transformative technologies. We provide a selection of safe, non-anatomy-changing lifestyle-enhancing products that are attractive alternative to pharmacological therapy or more invasive therapies. Lastly, we will continue to work with our world-class Scientific Advisory Board to continue to execute our plan for success in a global market that is changing in a historic fashion to normalize safe and effective treatments for obesity. This concludes our prepared remarks. So now we'd like to open the call to your questions. Operator?

Operator

[Operator Instructions] Seeing no questions, I would like to turn the conference back over to Paul Hickey for any closing remarks. Please go ahead.

Paul Hickey

Thank you. We are on a path to profitability, having restructuring the organization, focusing on increased shareholder value and establishing a sustainable and scalable business, and we'll continue our high-priority search for synergistic M&A opportunities while continuing the adoption of the Lap-Band 2.0 FLEX is project to be a growth catalyst for the company. As always, I want to thank our employees, Board members, customers, consultants, advisers, suppliers, existing and new shareholders for your continued support of ReShape as we progress on our mission to become the premier physician-led weight loss company. I look forward to continuing to engage with our stakeholders, health care partners, and shareholders. Thank you all.

Operator

This conference has now concluded. Thank you for attending today's call. You may now disconnect.

As of 2026-05-30 • Updated weeklySource: Earnings sourceIngestion runbook