Myomo Inc.

Good day, and welcome to MyoMo's second quarter of 2024 earnings call. All participants will be in a listen-only mode, and should you need any 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. If you would like to ask a question, you may press star, then one on your telephone keypad. And to withdraw yourself from the queue, please press star, then two. Also, please be aware that today's call is being recorded. I would now like to turn the call over to Kim Golodets with LHA. Please go ahead.

Thank you, Operator, and good afternoon, everyone. This is Kim Golodets with LHA. Welcome to the Miami Second Quarter 2024 Conference Call. Earlier this afternoon, Miami issued a news release announcing financial results for the three and six months ended June 30, 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 LHA at 212-838-3777 and speak with Carolyn Curran. With me on today's call from myomo are Paul Godonis, 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 myeloma's business, financial condition, and operating results. These and additional risks, uncertainties, and other factors are discussed in MIOMA's filing 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, MIOMA 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 my OMO CEO, Paul Godona. Paul, please go ahead.

Thanks, Kim, and good afternoon, everyone. Thank you for joining us today. We are delighted to report excellent financial results for the second quarter of 2024, which was the first quarter since the Medicare fees for the MyoPro powered arm braces went into effect beginning April 1st. As a result of our ability to add patients covered by standard Medicare Part B to our target market, we achieved quarterly records in revenues, additions to, and the total number of patients in the patient pipeline, authorizations, and MyoPro orders and shipments. As you know, the MyoPro is reclassified by CMS into the brace benefit category as of January 1st, 2024, which resulted in lump sum payments for these custom devices for patients with paralyzed arms. During the first quarter, Medicare paid claims for patients who met the agreed-upon criteria for medical necessity, however, the reimbursement amount was below the proposed allowable rate. The MyoPros delivered to patients after April 1st The approved fees were $65,872 for the MyoPro Motion G and $33,481 for the Motion W model. And just to note, the Motion G represents over 90% of our unit volume because it enables function of both the arm and the hand. We were able to recognize revenue on 74 MyoPros delivered to Medicare Part B beneficiaries during the second quarter, a population that we previously had to turn away. Shipments to these patients were in addition to the shipments to Medicare Advantage, VA, orthotics and prosthetics clinics, and international customers, all which contribute to growth in product revenues of 77% over the second quarter of 2023. Now when Medicare Part B patients contact us directly or are referred by a physician or therapist, our direct billing provider team can engage with them. This led to a record number of 550 additions to our patient pipeline in the quarter and 1,179 patients in the overall pipeline. As a reminder, the patients in the pipeline are those who have begun the reimbursement process. Our marketing spend is now far more efficient as we're able to expand this pipeline at a cost per candidate that was 26% lower than a year ago. During Q2, we received 213 insurance approvals, Part B medical documents, and orders from the VA system and O&P clinics, which is up 70% year over year. We received evidence of payments for the Medicare Part B claims much faster than we had anticipated, which, as Dave will explain, led to revenues coming at the higher than our guidance. We've also seen our average selling price, or ASP, trend upward to more than $47,000 in the second quarter with these payments under our direct billing operation, which are typically paid at 80% of the Medicare allowable amount, plus any co-pays by secondary insurance or out-of-pocket payments by patients. As for the Medicare Advantage plans, they are required to cover what standard Medicare covers, and we've seen mixed results from these payers so far. Dave will elaborate further in his remarks. We need to obtain a preauthorization for MyoPro for patients covered by these plans. In some cases, the approval percentage has gone down as these plans try to control their utilization costs post-COVID, which, of course, is contrary to Medicare regulations. Our chief medical officer works with patients to appeal certain cases at an administrative law judge hearing We've recently seen a positive trend with judges overturning denials by declaring that the MyoPro is not experimental or investigational or that it is not medically necessary since Medicare is covering the device. These are wins for the patients with these Medicare Advantage plans. I hope these decisions set a precedent with these payers and others. And more good news is that we've seen some of these Medicare Advantage plans start to remit payments to us at the Medicare rate, which is contributing to the higher ASP. To meet the growing demand from an expanded adjustable market, we've been adding capacity across the revenue cycle. We've added intake coordinators to answer inquiries. We've increased our reimbursement staff and licensed clinicians in the field. And we've added employees in our manufacturing quality and fulfillment operations. Our staff has increased from approximately 100 employees at the beginning of the year to about 160 currently. We're also finalizing plans to move to a larger production facility in the Boston area later this year to accommodate additional expected growth in shipments this year and in the future. Our international operations, primarily in Germany, continue to do well, generating over a million dollars of revenue in the quarter. We also expanded the clinical and business development teams to support the expected growth in this market. And with the clarity on the Medicare Part B reimbursement, we've seen keen interest from domestic O&P clinics since this is a patient population they already serve with ankle foot orthoses and other braces. We recruited an experienced O&P channel team of business development managers and clinical trainers, and we established a certification program for O&P clinics to become a MyoPro Center of Excellence. We started training some of these skilled professionals, and they plan to evaluate patient candidates in the near future. After receiving the necessary medical documentation to support reimbursement for their patients, we expect that they'll be placing their initial MyoPro orders later this year. Next month is the National Assembly for the American Orthotics and Prosthetics Association, which is the premier annual conference for the O&P industry. We've already planned a manufacturer's workshop, and we'll participate on a research panel to introduce the MyoPro to a larger audience of O&P clinicians. Our plan is to build this distribution channel over the coming months in order to add to the business produced by our own drug-filling operation in 2025. And 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 plans. Dave? Thank you.