HIND - NASDAQ

Good afternoon, and thank you for joining the ReShape Lifesciences Year-end 2023 Conference Call. I would like to turn the call over to Michael Miller from Rx Communications.

Good afternoon, and thank you for joining the year-end 2023 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, which will include a discussion with Dr. Christine Ren-Fielding, a member of ReShape's Scientific Advisory Board. Then Tom will review the financial results for the period. We'll then turn the call back over to Paul for some closing remarks, after which we will open 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 information -- 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'll 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 year-end 2023 earnings call. After I provide an overview and update on ReShape's activities, we will be joined by a member of our Scientific Advisory Board, Dr. Christine Ren-Fielding, Professor of Surgery at NYU Grossman School of Medicine, Director of the NYU Langone Weight Management Program and Chief of the Division of Bariatric Surgery. Dr. Ren-Fielding spoke on our second quarter 2023 conference call. She recently performed one of the first surgeries utilizing the next-generation Lap-Band 2.0 FLEX, and has been kind enough to join us once again to discuss her experience realizing this new version of the Lap-Band. Now let me begin. ReShape remains dedicated to achieving profitability by executing our growth strategies and maintaining our emphasis on creating shareholder value by focusing on our 3 growth pillars. Our story for 2023 is not unlike other businesses that have seen the impact of GLP-1 agonist prescription drugs, but we stand apart with those businesses that have responded quickly, made bold adjustments to the strategies and stabilized their businesses. The most important takeaway from this call is for our investors to understand that we remain dedicated to our first pillar of growth, which remains paramount for ReShape to achieve profitability and maintain our emphasis on creating shareholder value. Our steadfast focus on cost reductions while continuing to invest in growth drivers is intended to secure the long-term sustainability of the company. While GLP-1 prescriptions are now understood to be a long-term growth catalyst for the bariatric market, their short-term impact made it necessary to make additional strategic cost reductions, including a further reduction in staff leading to a projected 55.4% decrease in operating expenses for 2024 compared to last year. Tom and I will provide further details later 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. The limited launch of the Lap-Band 2.0 FLEX is progressing 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 programs with key Lap-Band centers have proved effective and scalable. Now before I recap our fourth quarter and subsequent highlights, I'd like to discuss and comment on important events occurring within the obesity market today. Whether you've understood the obesity market for years or just heard about it recently on Oprah's televised special, the 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. Their growing populated GLP-1 agonist has brought significant benefits to both those with type 2 diabetes and those who are obese. There's no doubt that the GLP-1 adoption is expanding the medical weight loss market by vastly reducing the statement that often occurs or on obesity and medical intervention, and we believe this includes bariatric surgery. However, it is becoming very clear that weight loss due to GLP-1 usage has limitations, especially the cost, accessibility and the fact that the 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 agonists were adherent after 1 year. We continue to believe, based on this 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 anatomy preserving weight loss treatment. In other words, once GLP-1 patients get a taste of weight loss yet have issues with the drug's accessibility, durability or their tolerance, patients will contemplate bariatric surgery, especially a minimally-invasive procedure like the Lap-Band. Now let me take a few minutes to update you on our progress related to our primary pillars. As I mentioned early in the call, I want to provide more specifics on progress made toward our first pillar, which will help us deliver shareholder value and ultimately, profitability. Specifically, as we consider the impact of GLP-1 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 are channeling investments into the most promising part of our strategy to drive growth and maintaining adherence to critical P&L metrics within our organization. Tom will detail the expense savings we have identified, realized and are planning for. But 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 billion. We have also executed a Reduction in Force of approximately $1.2 million and have decided to temporarily pause our ReShapeCare program and achieve an estimated savings of $0.8 million. We have also planned for $0.9 million of reductions for incentive compensation and other pay-related amounts. All part of streamlining our team significantly but without affecting revenue. Taken all together, these reductions will allow us to focus and invest in our growth drivers while at the same time, extend our cash runway. The changes are bold, necessary and indicative of our commitment to our first growth pillar, which I established late in 2022. And point of fact, with these 2024 reductions, the company's core operating expense reductions between 2022 and 2024 are estimated at $24 million or 75%. In addition to the necessary cost reduction initiatives related to our first growth pillar, we continue to make significant progress with our cost-effective digital lead generation and patient engagement campaign through our exclusive partnership with Hive Medical. As a reminder, this platform allows us to access advanced lead optimization software that can enhance patient engagement and increase patient volume. The software utilizes an AI SMS patient self-service technology, which, in combination with our targeted direct-to-consumer marketing campaign helps individuals effortlessly overcome new patient intake challenges. As a result, patients can easily book appointments with medical professionals at any time. We have seen an increase in the quality patient needs while successfully reducing costs in targeted markets where our surgeon advocates operate. Let's now discuss our progress executing our second growth pillar, to expand our portfolio or distribution. As previously reported, we continue our high-priority search for strategic and synergistic M&A opportunities having engaged the Maxim Group on an exclusive basis to assist in this process. As one can imagine, we have had a high level of activity, and we'll continue this effort to find the right partner for long-term success of ReShape Lifesciences. I'm also pleased to report that we continue to focus on the development and commercialization of new products and therapies. To that end, last month, we announced that the first surgeries utilizing the Lap-Band 2.0 FLEX were extremely successful and additional surgeries have already taken place. These first surgeries follow closely on the heels of getting the FDA PMA supplement approval for the Lap-Band 2.0 FLEX. Initial limited launch continues to gain traction and represents a leap forward in improving the overall Lap-Band patient experience. In a few minutes, Dr. Ren-Fielding will detail her experience with the Lap-Band 2.0 FLEX. And as a reminder, the new FLEX technology acts as a relief valve to alleviate discomfort from swallowing large pieces of food, eliminating the need for in-office band adjustments, as the band momentarily relaxes before returning to its resting diameter. In January, we had the opportunity to train surgical fellows on our Lap-Band system during which we also introduced the Lap-Band 2.0 FLEX. This was an exciting event given that the future of the Lap-Band is inextricably tied to its continued adoption by surgeons and surgical fellows who represent the next generation of bariatric surgeons. We believe, based on current surgeon feedback, including those who have already used the Lap-Band 2.0 FLEX, that the new FLEX technology will allow us to engage more surgeons as well as new and existing Lap-Band patients, leading to an increased demand for Lap-Band surgery, and ultimately becoming a true growth catalyst for the Lap-Band franchise and the company. At this time, I'd like to introduce Dr. Chris Ren-Fielding from NYU. As previously mentioned, Dr. Fielding is a member of our Scientific Advisory Board, has been a key opinion leader and expert in the field of bariatric surgery for decades. As I mentioned earlier, Chris performed one of the first surgeries utilizing our physician-led redesigned Lap-Band 2.0 FLEX designed to improve the patient experience. Chris, I'd like to ask you to give everyone your background and then discuss your experience with the Lap-Band 2.0 FLEX.

Thanks, Paul. Good afternoon, ladies and gentlemen. As mentioned earlier, I'm a Professor of Surgery at NYU Grossman School of Medicine, Director of the NYU Langone Weight Management Program and the Chief of the Division of Bariatric Surgery at NYU Langone Medical Center in New York City. I was recruited to create the Bariatric Surgery division in 2000 and was the first bariatric surgeon at NYU fresh out of training. With the following year in 2001, when the Lap-Band was FDA approved, that I became one of the first surgeons in the state to be trained on how to implant and manage the device. Within 2 months of the approval, I became one of the busiest and most prominent surgeons performing Lap-Band surgery. In the first 10 years, I implanted approximately 5,000 Lap-Bands. I became a consultant for BioEnterics and sat on their Clinical Advisory Board. I trained other surgeons on Lap-Band surgery as a proctor and by running workshops. I also lectured on Lap-Band surgery at other academic institutions, at other training workshops and at national and international conferences. I've published over 45 scientific research articles involving Lap-Band surgery outcomes to improve quality of care and decrease complications. I continued my consulting roles with the subsequent companies that own Lap-Band. First with Inamed, then Allergan and now at ReShape. Over the past 23 years, I have expanded NYU's Bariatric Surgery division, which now consists of 6 bariatric surgeons, 5 nurse practitioners, 3 registered dietitians, 2 psychologists and 1 social worker. We performed approximately 1,000 bariatric operations per year, including sleep gastrectomy, gastric bypass and Lap-Band surgery. However, about 30% of our operations are revisions or corrective operations to treat weight regain or complication. It is worth mentioning that the utilization of GLP-1 is having a tremendously positive impact in the weight loss community, in that more people than ever before are inquiring about medical weight loss options, which I believe will ultimately increase the number of patients who would consider surgery. In other words, now that GLP-1 patients have an open mindset to other weight loss options offered to them, especially those that are more accessible, durable and tolerable than the long-term use of GLP-1s, they will actually contemplate bariatric surgery, including minimally invasive procedures like the Lap-Band and Lap-Band 2.0 FLEX. The Lap-Band is the safest bariatric surgery option as proven by multiple large population studies and vast personal experience. This was the primary reason for the rapid initial uptake of Lap-Band surgery in the 2000s. Patients love it because it was an outpatient procedure with quick recovery time, which allowed them to lose more weight every time they came in for their band to be tightened. It also gave them accountability and long-term connection with the practice, which motivated them. Childbearing women have been remarkably successful with weight management during pregnancy using the band and weight loss after pregnancy because the band can be adjusted to help them lose weight afterwards. The band can be loosened during pregnancy and then retightened after delivery. To this day, I still have hundreds of patients who have had their Lap-Band intact for over 15 years and have maintained 100 pounds or more of weight loss. However, over time, there were issues with some patients and the management of band adjustments and related therapy levels, particularly when it required urgent loosening to relieve food obstructions caused by the patient's attempt to consume more food than the band will allow. In these scenarios, the surgeons and patients became frustrated and eventually became discontent with the device. I've long looked forward to the launch of the Lap-Band 2.0 FLEX as it will potentially remedy this issue due to its ability for self-correction, utilizing an internal reservoir system thus limiting the need for manual band adjustments in these instances. Specifically, pieces of food that were once too large to pass through the narrowed passage can now pass through into the stomach because of the new FLEX technology since it allows the band to relax momentarily under normal swallowing forces and then return to its resting diameter. What's even more exciting for me and other clinicians is the adoption of multimodal or what we call combination therapy that is becoming a mainstay in the bariatric surgery field, meaning GLP-1 agonist can be used to complement and augment weight loss after surgery to help prevent weight gain. This ability for self-correction along with its ability to partner with GLP-1 agonist makes the Lap-Band 2.0 FLEX a better long-term weight loss solution for my patients, and I look forward to increasing its usage in my practice going forward. I hope these insights have been helpful. I look forward to answering questions later during this call. I will now pass the call back to Paul.

Thank you, Chris. As a leader in the field, we appreciate your opinions and first-hand experiences. We remain confident that with our Lap-Band 2.0 FLEX and legacy Lap-Band, we are uniquely positioned with the least invasive, safest and most durable weight loss option for these 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 usage has limitations related to comorbidities and accessibility, we believe that the marketing opportunity for the Lap-Band 2.0 FLEX and Lap-Band will increase over time. From a continuum care perspective, these patients are likely potential candidates for bariatric surgery as the next viable weight loss treatment. Before I turn the call over to Tom, I want to remind everyone that we have worked diligently to strengthen our IP position, most recently evidenced by the notice of allowance from the U.S. Patent Office for an additional patent covering an intrinsic balloon system. As always, we will continue to build a defensive moat around our product portfolio and commercialization efforts and take offensive actions when it is appropriate. I look forward to providing updates to you all in this important area in future updates. I would now like to 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, in November and in response to continued pressure on the company's revenue caused by the adoption of GLP-1s, we are reorganizing the company and have identified cost reductions of approximately $8 million or more than 50% for 2024 alone. Specifically, a Reduction in Force of approximately $1.5 million, which began in November and December, 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 reduction in selling and marketing costs of $2.4 million without affecting our continued marketing spend optimization; costs related to the pause of our ReShapeCare program totaling $800,000; expenses related to G&A totaling $1.3 million, which are primarily in professional and consulting fees and insurance costs; and R&D expenses totaling $900,000, which 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. A full discussion of our actual financials is available in today's press release and 10-K. So I will just take a moment to review key financial metrics for the year ended December 31, 2023. Our revenue totaled $8.7 million for the year ended December 31, 2023, which represents a contraction of $2.6 million compared to the same period in 2022. The primary reason for this decrease is due to the introduction of GLP-1 prescriptions within the U.S. This is also evidenced by a decrease of Lap-Band unit sales of approximately 27%. We continue to focus on our new marketing strategies 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 come to fruition in 2024. Additionally, we anticipate a full U.S. launch of the Lap-Band 2.0 FLEX in 2024 that should contribute to increased sales going forward into 2024 and beyond. Gross profit for the year ended December 31, 2023, was $5.5 million compared to $6.8 million for the year ended December 31, 2022, a decrease of $1.3 million. Gross profit as a percentage of revenue for the year ended December 31, 2023, was 64% compared to 61% for the same period in 2022. The increase in gross profit margin is primarily due to the company allocating resources that were previously and primarily focused on inventory to other projects and allocate a larger percentage of costs to operating expenses in 2023. Sales and marketing expenses for the year ended December 31, 2023, decreased by $6.6 million or 47% to approximately $7.5 million compared to $14.1 million for the same period in 2022. There was a decrease of $5.2 million in advertising and marketing expenses as we reevaluated our marketing approach and have moved to a targeted and AI-supported digital marketing campaign. There were also $1.2 million of reductions in payroll-related expenditures including commissions, travel and stock-based compensation as part of the Reduction in Force. General and administrative expenses for the year ended December 31, 2023, decreased by $7 million or 40% to $10.3 million compared to $17.3 million for the same period in 2022. The decrease is primarily due to $2.6 million in litigation losses we incurred in 2022. In addition, the company had a reduction in payroll-related expenses, including stock-based compensation expense of $2.8 million due to our cost reduction efforts. Other reduction included intangible asset amortization as the company impaired the finite intangible assets during the fourth quarter of 2022, and a decrease in rent and insurance for the expired lease of our former Carlsbad, California location. Research and development expenses for the year ended December 31, 2023, decreased by $200,000 or 9% to $2.3 million compared to $2.5 million for the same period in 2022, which includes a slight decrease, primarily in payroll expenses, depreciation, consulting and clinical-related expenses. Non-GAAP adjusted EBITDA was $13.6 million for the year ended December 31, 2023, compared to a loss of $23 million for the same period last year. We ended this year with $4.5 million in cash and cash equivalents and remain debt free on our balance sheet. As we move forward into 2024, we anticipate our revenues 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's important to reiterate, as both Tom and I have detailed, that we have and will continue to adjust our 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 acquisition, segmented customer-centric messaging via an updated website for improved patient engagement, and a frictionless booking 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 develop and offer a portfolio that is differentiated from the competition with transformative technologies that consist of a selection of patient-friendly, non-anatomy-changing lifestyle-enhancing products that provide alternatives to more invasive bariatric surgeries to help patients achieve healthy durable weight loss. At the same time, we will continue to work with our world-class Scientific Advisory Board to continue to execute our plan for success in the global market that is changing in historic fashion to normalize safe and effective treatments for obesity. This concludes our prepared remarks. So now I would like to open the call for your questions. Operator?

[Operator Instructions] This concludes our question-and-answer session. I would like to turn the conference back over to Paul Hickey for closing remarks. Please go ahead.

Thank you. I hope that you appreciate our steadfast commitment to enhancing the efficiency of our company through the revamping of the organization, to continue our quest for shareholder value as a sustainable, scalable company. We will continue to work diligently to build on our commitment to provide evidence-based personalized devices. A special thanks to Dr. Ren-Fielding for participating in today's call. As always, I want to thank our employees, Board members, customers, consultant advisers, suppliers, existing and new shareholders for their 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.