HIND - NASDAQ

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.

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?

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?

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.

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

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.