Myomo Inc.

Good day and welcome to the MIOMO third quarter 2024 financial results 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 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 Tim, I'm sorry, to Kim Golodetz.

Please go ahead. Thank you, Operator, and good afternoon, everyone. This is Kim Golodetz with Alliance Advisors IR. Welcome to the Mioma Third Quarter 2024 Conference Call. Earlier this afternoon, MyOMO issued a news release announcing financial results for the three and nine months ended September 30th, 2024. If you would like to be added to the company's email distribution list to receive future announcements, please register on the company's website at myomo.com or call Alliance Advisors IR at 310-691-7100 and speak with Danny Chertok. With me on today's call from IOMA are Paul Godonas, Chairman and Chief Executive Officer, and Dave Henry, Chief Financial Officer. 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 MIOMA's 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, MyOMO undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this call. It is now my pleasure to turn the call over to MyOMO CEO, Paul Godonis. Paul, please go ahead.

Thanks, Kim. Well, good afternoon, everyone, and thanks for joining us today. We achieved another quarter of strong growth in the third quarter of 2024, building on our momentum since the Medicare fees for the MyoPro powered arm braces went into effect beginning April 1st. We're now able to serve the many patients in the US who are covered by standard Medicare Part B And we achieved quarterly records in important business metrics, including revenue, revenue units, pipeline ads, border rent pipeline size, insurance authorizations and orders, and MioPro shipments. But with the reclassification of the MioPro into the brace category and the publication of the Medicare allowable earlier this year, we established three major objectives for the company. Start providing the MyoPro, the eligible standard Medicare Part B beneficiaries who we had to turn away before. Engage the many orthotics and prosthetics clinics across the country who 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'll provide a status report on these initiatives by reviewing the key data points across our revenue cycle, from patient candidates who are interested in MyoPro through to revenue units in the quarter. We added 645 medically qualified candidates to the patient pipeline, which is up 69% from the year-ago quarter as our addressable market is increased to include Medicare Part B patients that did not have access to the MyoPro in the past. Our marketing efficiency also improved with the cost per pipeline ad down 25% from last year to $1,618 per qualified ad. We received insurance authorizations and orders for a record 225 MyoPros in the third quarter, including medically qualified Medicare patients, which was up sequentially and also up 44% year over year. Revenue units based on devices delivered to patients or payments received totaled 161 MyoPros, up 35% from a year ago, and the ASP, or the average selling price, increased to an adjusted $52,700 per unit, as Dave, our CFO, will explain. As a result of more MyoPro volume and a higher ASP, our product revenue is a record $9.2 million, up 83% over the same period in 2023. These revenue units included 87 myopros delivered to Medicare Part B beneficiaries, and this is in addition to the shipments to Medicare Advantage, VA, orthotics and prosthetics clinics, and international customers. With the large number of additions to the patient pipeline, we exited the quarter with 1,263 candidates in the process of obtaining a physician's order and the necessary medical documentation for a myopro. And with a large number of new orders, our backlog stood at a record 316 units, which represents over $16 million of potential revenue. As for developing the O&P channel, in September, we attended the American Orthotics and Prosthetics National Association Assembly, which is the largest conference for orthotics and prosthetics, or O&P clinics, in the U.S. With clarity on Medicare Part B reimbursement, we're now able to recruit these O&P clinics to provide the myoprobe to stroke survivors, knowing that this is a patient population they already serve with ankle, foot orthoses, and other braces. Our team of business development managers and clinical trainers serving this O&P channel is up and running, and we have a standing room only crowd of more than 100 clinical professionals attending our manufacturer's workshop at the conference. To train these clinicians on the MyoPro, we launched the MyoOmo Academy, which is an online learning platform specifically for O&P professionals. We're also conducting a number of in-person training sessions as part of the certification program for O&P clinics to become a MyoPro center of excellence. These training sessions have included many independent O&P clinic owners and CPOs, which are certified prosthodontists, orthodontists, as well as Hanger Clinics, which is the largest nationwide operator of O&P clinical facilities. We set a goal of recruiting and training 100 clinicians by the end of this year, and I'm pleased to report that we've already surpassed that goal. These prosthetists and orthodontists are now starting to evaluate patients, and after they receive the necessary medical documentation, they'll begin to place orders for custom eye opal for their patients. We've already seen an uptick in activity from the O&P channel, and we expect that O&P orders will increase in 2025 as their patient pipelines are growing. Order can take several months for patients to see their primary care or other qualified physician and to obtain all the necessary clinical notes, which are required before a mile per order can be placed. While our direct provider business with Medicare, our international operations, and our progress with the O&P channel have been going well, I'm frustrated with some of the Medicare Advantage plans. Rather than following Medicare's lead in covering the MyoPro for their members, we've seen mixed results from these payers so far. It's been widely reported that some Medicare Advantage payers are making it more difficult for patients and providers to get the care they deserve, which is what we are seeing as well. As a result, more authorization requests are being denied initially, forcing us to file more appeals for pre-authorizations with some plans. On the other hand, some Medicare Advantage plans that did not cover the MIOPRO in the past have started to do so, which is a good thing for their members. Additionally, the good news is that we've seen some of the Medicare Advantage plans pay a more appropriate amount now that the Medicare allowable rate has been published. As for the third objective, contracts with payers, since this year's developments with Medicare, our chief medical officers have been working with private payers to begin the contracting process for Myomo to become an in-network provider. While this can be a multi-year process due to the meetings required with medical directors and then the contracting staff, we recently announced we've entered into our first two contracts, one with Blue Cross Blue Shield of Massachusetts, another with Paradigm, which is a leading workers' compensation organization. Together, these two payers represent 3 million covered lives at the Blue Cross Blue Shield plan, plus employees served by Paradigm for workplace injuries. We have other ongoing dialogues with other payers, which we believe will lead to additional contracts down the road. With the growth in the pipeline, orders, and channels even adding capacity to meet demand, We've gone from about 100 employees at the beginning of the year to 180 now, and we'll be moving to a larger production facility in the Boston area later this year to accommodate the expected growth in shipments this quarter and in the future. As I mentioned, our international operations based in Germany continue to perform well, with a record $1.1 million of revenue in the quarter. Also, our China joint venture, Jiangxi Myomo, is making progress in obtaining the necessary regulatory approvals from the NMPA, equivalent of a Chinese FDA, to begin sales and production of Myomo units, in addition to undertaking a clinical trial with some key hospital partners as part of their market access plan. We don't expect much in the way of revenue from China at this point, but we're getting well-positioned to capitalize on this very large opportunity. With that overview, I'll turn the call over to our CFO, Dave Henry, for a deeper dive into the quarterly financials, and I'll return with some additional comments on our business plan.