Myomo Inc.

Good afternoon, and welcome to the MIOMO's first quarter 2025 earnings conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask your question, you may press star, then one on a touch-tone phone. To withdraw your question, please press star, then two. Please note, this event is being recorded. I would now like to turn the conference over to Tarith Patel, Please go ahead.

Thank you, Operator, and good afternoon, everyone. This is Turth Patel with Alliance Advisors IR. Welcome to the MIOMO First Quarter 2025 Conference Call. With me on today's call are MIOMO's Chief Executive Officer, Paul Godonis, and Chief Financial Officer, Dave Henry. Before we begin, I'd like to caution listeners that statements made during this call by management other than historical facts are forward-looking statements. The words anticipate, believe, estimate, expect, intend, guidance, outlook, confidence, target, project, and other similar expressions are typically used to identify such forward-looking statements. These forward-looking statements are not guarantees of future performance and may involve and are subject to risks, uncertainties, and other factors that may affect my own most business, financial condition, and operating results. These risks, uncertainties, and other factors are discussed in MIOMA's filings with the Securities and Exchange Commission. Actual outcomes and results may differ materially from what's expressed in or implied by these forward-looking statements. Furthermore, except as required by law, MIOMA undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this call today, May 7, 2025. It's now my pleasure to turn the call over to Myomo CEO, Paul Godonez. Paul, please go ahead.

Thanks, Turth. Good afternoon, and thank you all for joining us today. During our Q4 earnings call in March, I commented on our first mover advantage with MyoPro, and I shared that we are the technology leader with an exciting product development roadmap, and we also earmarked a good portion of the proceeds from our December 2024 capital raise to expand our R&D capabilities. Already in 2025, we've introduced two product upgrades, the Mark II clinical unit and the MyoPro 2X. The Mark mobile arm rehab kit is an adjustable universal size device used by clinicians such as rehab therapists and certified prosthetists to demonstrate how a patient can move their arm and hand with our powered arm brace and to conduct an evaluation of the patient to see if they're a good candidate for their own custom MyoPro. This device is critical to developing our new orthotics and prosthetics O&P distribution channel so that they can recruit and build their own patient pipelines. And just last week, we announced the launch of the MyoPro 2X, an upgraded version of the MyoPro 2+. The launch of the MyoPro 2X reflects our strategy of continuous innovation based on real-world patient and clinical experience and aims to improve independent device use and support of daily functional tasks. After a thorough product development process, including clinical input from our own staff and other O&P professionals, and the knowledge gained from helping over 3,000 patients who've already received a MyoPro, we're excited about the benefits of this new version of our flagship device. MyoPro 2X is our most advanced product that leverages our first mover position. We've already started to take orders for it from our direct provider business and our O&P channel partners. that there's more innovation to come as we continue development of next-generation MyoPro3 and other enhancements that we'll be delivering to patients in the future. Along the Q1 metrics, we're reporting strong year-over-year revenue growth, including from Medicare patients. The conclusion of Q1 marked the one-year anniversary of Medicare coverage of the MyoPro orthosis for medically qualified patients, as patients covered by Part B have had access to the myoprobe with the lump sum fee schedule since April 1st, 2024. While the first quarter exhibited the typical seasonality of previous years, we achieved strong revenue growth while addressing some temporary speed bumps. The changes in how marketers can direct their messages to individuals with certain health conditions made by Meta, which operates Facebook and other social media platforms, impacted our lead generation efforts in January and February. We saw a similar downturn in patient leads when Apple introduced restrictions on personal health information on the iOS mobile operating system several years ago. As we've done before, we've successfully adjusted our advertising approach and improved generation of leads in March and a record number of leads in April. However, we have fewer patients moving through the authorization process in Q1 than in our internal plans. In addition, Medicare Advantage and certain other commercial insurance plans continue to deny or delay authorizations for a large percentage of physician orders for a myopro. As a result of these two factors, our authorizations were only up 18% year-over-year, our cost per pipeline ad increased, and after delivering approximately 180 units in the quarter, our backlog was down year-over-year, heading into Q2. So while we expect slightly lower revenue in Q2 versus Q1, we've addressed these new challenges and have some very positive metrics to report today as we reaffirm our financial targets for the year. We delivered 182 MyoPro revenue units in the first quarter, up 100% from Q1 2024, and our ASP increased by about 30% over the prior year. Q1 revenues increased by more than 160% to $9.8 million, with Medicare Part B patients representing 60% of revenue. We added a record 700 medically qualified candidates to our patient pipeline during Q1 and ended the quarter with a record number of nearly 1,500 patients in the process of obtaining a MyoPro. 213 MyoPros were authorized and ordered in Q1, And our international business, which is primarily sales via O&P providers in Germany, performed well again, generating over $1.3 million in revenue. Earlier this year, we completed our move from downtown Boston to our new facility in Burlington, Massachusetts, with manufacturing capacity now at 120 units per month, which includes revenue units, MyoPro 2X demo units, and the new Mark II clinical evaluation devices. We're now planning for the next phase of floor space expansion to meet our forecast demand for later this year and beyond. While we increased our advertising spend in Q1, as I mentioned, we were temporarily impacted by how META changed its policies about personal health information that is available to marketers on Facebook. It took our ad agency several weeks to adjust to these changes. So our advertising efficiency was down for the first half of the quarter, resulting in a higher cost for pipeline ad at that time. And we still added a record 700 candidates to the patient pipeline. And based on our results that we've seen in March and April, we have rebounded well with the modifications we put in place. We continue to expand our presence in the ONP channel with outreach by our team of account reps and clinical trainers and participation in various industry events. We've been recruiting and training ONP industry practitioners on the MyoPro, and these clinicians are now ready to move into the next phase of becoming a certified MyoPro Center of Excellence. MyoPro is clinically complex, and these external clinicians must make a large commitment to learn the product, educate their local referral sources, and work patient by patient and insurance by insurance for coverage. Even so, these early adopters in the ONP channel are making the necessary commitments to begin dispensing the MyoPro to their qualified patients. We've now done initial training for more than 300 CPOs, up from 160 at the start of the year, so these CPOs can begin assessing patients and building their own MyoPro pipelines. Our O&P revenue was $475,000 in Q1, up 87% from a year ago, but down $125,000 sequentially, reflecting the seasonality of this channel. For our O&P partners, we offer robust remote and on-demand training for our learning management system, while most of the clinical training is being completed in person at the O&P clinics and facilitated by our growing team of clinical trainers. We're adding more ONP clinics across the country, including more Hanger regional offices who can engage with their patients. After these sessions at their locations, we support our ONP partners with other training in the field. For example, we regularly join clinical and services to demonstrate our technology to therapists and other clinicians who treat patients that might benefit from a myopro. And with the release of the new MyoPro 2X, we are conducting multi-day certification classes at O&P clinics, which include evaluating patients for MyoPro to expand their patient pipeline and revenue potential. We expect this channel's growth to accelerate during the rest of the year. However, order flow will depend on the reimbursement environment and the insurance mix of the patients they see. As for the current reimbursement environment, not much has changed since our last call. Access for patients covered by standard fee-for-service Medicare Part B is going very well and has been the largest source of our growth over the past 12 months. But too many patients are still being denied a MyoPro by Medicare Advantage and certain other commercial payers. This is the same situation impacting other health care providers and resulted in fewer authorizations and orders than we anticipated in the first quarter. In our direct billing channel, we advocate for the patients on a case-by-case basis. by working with their physician and CPO to determine the clinical candidacy and obtain appropriate medical records and documentation, all of which are needed to request an authorization from their insurer. If our requests are denied, we file appeals, and when necessary, take insurance denials all the way to the administrative law judge hearings. We're often successful, but too many times patients are not able to get a myopro because of these high denial rates, or the timeline for resolution for pre-authorization can remain lengthy and variable. To improve this insurance access, our chief medical officer is working closely with legal counsel and will continue to engage with payer medical directors to cover the MIOPRO for their enrollees. In addition to working to change payer policies, we continue to enter into contracts with health insurance plans to become an in-network provider with our direct billing business. We signed several new state contracts since the beginning of the year. We have negotiations underway with some of the national health insurance plans. At this point, we've executed or are in the process of finalizing contracts covering 25 million lives, including several new state Blue Cross Blue Shield plans. Before I pass the call to Dave, we previously shared that we overachieved our goal of break-even cash flow from operations in Q4 of 2024, and we completed a successful capital raise at the end of last year to fund our growth plans for this year and beyond. We're actively deploying those funds and making investments in marketing, product development, and the own feed distribution channel as we work to be cash flow positive again before the end of the year. I'll now let our CFO, Dave Henry, provide some more details on our financial performance.