Myomo Inc.

Good afternoon and welcome to the MIOMO fourth quarter 2024 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 a question, you may press star then one on your telephone keypad. 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 Tarth Patel. Please go ahead.

Thank you, Operator, and good afternoon, everyone. This is Tarth Patel with Alliance Advisors IR. Welcome to the MIOMO fourth quarter and full year 2024 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 conference 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 certain risks and uncertainties and other factors that may affect my own most business, financial condition, and operating results. These and additional risks, uncertainties, and other factors are discussed in MIOMA's filings with the Securities and Exchange Commission, including on Forms 10-K and 10-Q. Actual outcomes and results may differ materially from what's expressed in or implied by these forward-looking statements. Except as required by law, MIOMO undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this call today, March 10th, 2025. It's now my pleasure to turn the call over to MIOMO's CEO, Paul Gadonis. Paul, please go ahead.

Thanks, Terz, and good afternoon, everyone. Thanks for joining us. 2024 was a transformational year for MIOMO. capped off by a milestone fourth quarter as we generated record financial and operating results by capitalizing upon market access for patients covered by Medicare Part B. After several years of discussions with CMS staff and medical directors, Medicare began paying for the MyoPro powered honor base for medically qualified patients beginning April 1st of last year. This resulted in an inflection point for our business as we gained the ability to serve roughly 50% of the market that we had previously turned away. During our last quarterly conference call, I laid out three major objectives for the company. One, to start providing the MyoPro to eligible standard Medicare Part B beneficiaries. Two, to engage the many orthotics and prosthetics clinics across the country who, because of the CMS decision, would now be interested in becoming a distribution channel for us. And three, begin the process of establishing contracts with payers for in-network status of our direct provider business. I added two other objectives to support our growth plans and create a profitable business here. Increase our capacity from our call center to manufacturing operations and clinical reimbursement staff to enable continued volume and revenue growth in 2025 and beyond, and to achieve cash flow break even by the end of the year as our revenue scaled up. Today, I'm delighted to share the progress we've made on each of these objectives starting with a review of our Q4 accomplishments and full year results. Revenues were $12.1 million for the fourth quarter and $32.6 million for the full year, more than double the quarterly revenue in Q4 23, and 69% higher revenue than the previous year. We delivered 220 revenue units in the quarter, double the volume of Q4 23, and more than 600 devices during the year. We've now provided MyoMo products to more than 3,000 patients and hospital customers, solidifying our position as the market leader in the upper extremity paralysis category. During Q4, we added 657 medically qualified candidates to our patient pipeline, and we ended the year with a record number of nearly 1,400 patients in the process of obtaining MyoPro. A record 233 MyoPros were authorized and ordered in Q4, with more than 140 of them covered by Medicare in our direct provider channel. With greater clarity and reimbursement, we built a team of business development specialists and clinical trainers to engage these ONP clinics. And this effort exceeded our expectations with 160 certified prosthetists trained, far outpacing our goal of 100. These CPOs can now begin assessing patients and building their own MyoPro pipelines. One sign of progress in establishing this new channel is that our O&P revenue grew to $600,000 in Q4, up 94% sequentially as more O&P clinics began the process of becoming a MyoPro center of excellence. Our international business, which is primarily sales via O&P providers in Germany, performed well in the quarter, again generating over $1 million in profit revenue and over $4 million for the full year. Our China JV is working on a clinical trial to obtain regulatory approval to begin selling the Myomo products to patients and hospitals later this year. Building out the LFP distribution channel is a critical part of our long-term strategy. While Myomo's direct provider model allows us to work directly with patients and insurers, the LFP channel provides a scalable way to expand reach and drive adoption through an established clinical network. The demand from LFP clinics is increasing, as they recognize MyoPro as a complementary solution for their patient base. We're supporting these partners through several methods, hands-on clinical training and certification. As I mentioned, we exceeded our initial goal by training 160 CPOs in 2024, and we expect to further scale this effort in 2025. With improved reimbursement clarity, greater understanding of Medicare coverage has led O&P clinics now having a clearer pathway to secure payment for the MyoPro. And through dedicated field support, we've deployed a team of business development specialists and clinical trainers to help ONP clinics onboard patients, navigate reimbursement, optimize delivery processes. Although this channel is still in its early stages, we expect ONP-driven revenue to increase meaningfully in the second half of 2025 as more clinics begin generating orders. Importantly, the high-touch nature of ONP clinics means that patients can receive in-person evaluations, measurements and fittings leading to a convenient adoption process. While reimbursement for patients covered by standard fee-for-service Medicare Part B is going well, we still see too many patients being denied a MyoPro by Medicare Advantage and other commercial payers. The situation has not improved over the last three to six months and reflects the same reality other healthcare providers face with these payers. Our Chief Medical Officer and Legal Counsel, We'll continue to make the case for coverage by engaging with payer medical directors and by advocating for patients by filing appeals and taking denials all the way to administrative law judge hearings where we've been successful in making a case for medical necessity and a favorable ruling for the patient's myopro. On the payer front, my third objective for the business was to enter into contracts with health insurance plans so that myOMO can be an in-network provider with our direct billing business. We continue to make progress obtaining payer contracts. Since our third quarter call, five new contracts have been entered into or in the final stages of taking effect. These new contracts are primarily state Blue Cross and Shield plans, and altogether we now have signed and pending contracts covering approximately 18.6 million lives. As for the two additional goals I set for the company, here's how we've done. We relocated operations from downtown Boston to a new 35,000 square foot facility in suburban Burlington. We increased our manufacturing capacity to 120 units per month, more than doubling since the beginning of 2024. This enables us to produce MyoPro revenue units, clinical evaluation units, and the demo units we need to support our growing internal staff and the L&P channel. We also hired 100 people during the past year bringing our year-end headcount to 190, and we plan to continue hiring to expand capacity to serve a larger number of patients this year. I'll wrap up by pointing out that we overachieved in our fifth objective to become operating cash flow break-even by Q4, and we completed a successful capital raise to fund our growth plans in 2025 and beyond. I'll now let our CFO, Dave Henry, provide the details on these financial statements. Thank you, Paul, and good afternoon, everyone.