11/10/2025

speaker
Operator
Conference Operator

Good day and welcome to the MyOMO 3rd Quarter 2025 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 0. After today's presentation, there will be an opportunity to ask a question. To ask a question, you may press star then 1 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 Tarth Patel with Alliance Advisors IR. Please go ahead.

speaker
Tarth Patel
Investor Relations, Alliance Advisors IR

Thank you, Operator, and good afternoon, everyone. This is Tarth Patel with Alliance Advisors IR. Welcome to the MIOMO Third Quarter 2025 Financial Results Conference Call. With me on today's call are MIOMA's Chief Executive Officer, Paul Godones, 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 MIOMO's business, financial condition, and operating results. These risks, uncertainties, and other factors are discussed in MIOMO'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, MIOMO undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this call today, November 10th, 2025. It's now my pleasure to turn the call over to MIOMO's CEO, Paul Gadonis. Paul, please go ahead.

speaker
Paul Godones
Chief Executive Officer

Thanks, Terz. Good afternoon, and thank you all for joining us today. I'm pleased to announce that myOMO had another strong quarter with revenue of $10.1 million coming at the high end of our expectations. This was driven by record revenues in our international markets and a growing number of O&P providers. In addition, we saw our pipeline increase, and for the first time this year, our quarterly authorizations and orders increased sequentially. We're seeing more Medicare Advantage payer authorizations and orders from the new in-network contracts we signed earlier this year. Before turning the call over to Dave to review the financial results in detail, I'd like to touch on the progress we made during the quarter on the key initiatives that we outlined on our last call, which were to, one, improve the identification and qualification of prospective patients, two, expand the MyoConnect program and O&P channel, three, and insurance coverage, and four, reduce our overall operating costs. First, as mentioned, a core area of focus has been improving the identification and qualification of prospective patients. The number of new patient candidates who qualify for MyoPro is growing, and with the shift in our advertising media mix, the cost per pipeline ad is beginning to decrease. In Q3, we shifted more of our advertising spend to TV from social media. which yielded a higher percentage of leads that met our clinical criteria to become a successful patient, and these candidates were also more motivated to quickly complete the screening process. Thus, we enhanced the quality of our pipeline ads, as well as generating a sequential increase in the number of candidates in the pipeline. We've hired a new head of marketing with extensive experience in healthcare, direct-to-consumer advertising, as well as B2B marketing to support our efforts particularly in and reinforcing our message to physicians, therapists, and O&P practitioners. We will optimize the use of our various media to educate patients, family members, clinicians, and payers about the benefits of the MyoPro. Second, we believe the path to lowering customer acquisition costs is by developing recurring sources of patients that do not depend on a prospective candidate's self-initiating response to a paid advertisement. That is central to our new MyoConnect program and the growing O&P channel. Our MyoConnect clinical referral program is off to a good start, generating high-quality patient referrals by therapists and physicians at rehab clinics around the country. Importantly, there is no advertising expense incurred to educate these clinicians and these patients since we're already engaged with them. In mid-year, we launched MyoConnect, Our field clinical team is engaging directly with therapists and physicians across the country to expand the network of clinicians who understand the benefits the MyoPro can produce. These clinical practitioners who are responsible for the design and delivery of patients' treatment protocols can refer qualified patients to us and to our local O&P channel partners. Over the years, we have trained numerous occupational therapists, and they've seen the improvement in patient functionality from the MyoPro. Their willingness to refer patients was facilitated by CMS's decision to cover the MyoPro for Medicare reimbursement and by the introduction of the new MyoPro 2X model this past spring. The result is we're beginning to see more OTs and physicians sending their patients our way to obtain a MyoPro. But while it's still early in the rollout, we're encouraged by the initial traction and believe this program can develop into a scalable and cost-efficient source of high-quality referrals over time. Another source of recurring orders is the ONP channel, and we're continuing to provide clinical and reimbursement education and certification to the ONP practitioners, which is the mechanism to expand adoption in this channel. In September, we attended the American Orthotics and Prosthetics Association National Assembly, which is the major trade show for the ONP industry. We had a productive set of meetings with existing and prospective channel partners, I'm confident that sales to these clinics will continue to grow as we diversify our revenue sources beyond our direct-to-consumer advertising and direct billing business. Revenue from this new ONP channel more than doubled year over year, and their patient pipelines are growing with the training and clinical support we're providing to these certified prosthetists. In the past 45 days, I've had meetings with senior managers of the large and small O&P clinical groups in the industry as we work together to bring the MyoPro to their patients. We have good working relationships with these firms, and they are eager to work with MyoPro on programs to help improve the upper extremity impairments that this important segment of their patient population has. They already treat stroke patients with various lower extremity assistive devices to enable their mobility. Meanwhile, our O&P channel partners in Germany placed a record number of orders in the quarter, leading to strong growth in revenues from our international operations and a greater number of patients in the pipeline for continued growth. In order to expand insurance coverage, our chief medical officer and reimbursement team have been following up with the major Medicare Advantage payers to obtain more MyoPro authorizations for their beneficiaries. We saw a sequential increase in authorizations for patients covered by some of these plans and from payers with whom we have contracts. These positive results led to the higher number of authorizations and orders this past quarter. During Q3, we signed an additional contract with a payer to become an in-network provider for our direct billing business, which now brings us to 35 million covered lives among private payers. We have other contracts pending as well as to increase access to a MyoPro for patients covered by these commercial health insurance plans. There's also a development in the payer industry that could be positive for MyoMo. Insurance companies that offer Medicare Advantage plans are withdrawing Medicare Advantage coverage from certain geographic areas, thereby reducing their member count. For example, UnitedHealthcare projects a one million member drop and other payers are making similar announcements. If these patients choose to enroll in standard fee-for-service Medicare, those that are medically qualified for MyoPro may be more likely to obtain our device for their paralyzed arms under Medicare Part B coverage. If the support increased reimbursement, we continue to add to the published research on the MyoPro during Q3, a highly respected topics and stroke rehabilitation journal published a systematic review of patient outcomes from the use of the myoelectric orthosis. Providing this information to payers, rehab physicians and therapists, as well as O&P professionals can lead to greater insurance coverage and clinical adoption. Lastly, during the quarter, we implemented manufacturing changes to improve our gross margin, also managed headcount and other cost reductions to lower operating expenses. We're positioning ourselves for improved operating leverage as we grow future revenues based on the larger patient pipeline augmented by the increased number of authorizations and orders we expect from the MyoConnect program and the expanded O&P channel. Based on the backlog going into the fourth quarter and the number of patient cases progressing through reimbursement, we're able to reiterate our full 2025 annual guidance of $40 million to $42 million. which represents an increase of more than 23% over last year. With that overview of our performance and actions, I'll turn the call over to our CFO, Dave Henry, to provide more of the financials and details on our newly executed term loan facility, which is designed to provide us with growth capital to continue scaling the business to sustainable profitability and positive cash flow as our MyoPro volumes and revenue increase.

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