Myomo Inc.

Good afternoon, and welcome to the MyOMO Incorporated first quarter 2022 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 Kim Golodets with LHA. Please go ahead.

Thank you, Operator, and good afternoon, everyone. This is Kim Golodets with LHA. Welcome to the MIOMA First Quarter 2022 Conference Call. Earlier today, MIOMA issued a news release announcing financial results for the three months ended March 31st, 2022. 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 myoma.com or call LHA in New York at 212-838-3777 and speak with Carolyn Curran. With me on today's call from myoma are Paul Godones, 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, including the impact of COVID-19. These and additional risks, uncertainties, and other factors are discussed in the risk factors and other qualifications contained in MIOMA's filings with the Securities and Exchange Commission, including the Form 10-K for the year ended December 31, 2021, and subsequent filings. 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 Godoner. Paul, please go ahead.

Thank you, Kim. Good afternoon, everyone, and thank you for joining us. Our first quarter product revenue was right in line with our expectations. Product revenue growth of 23% year-over-year reflects a higher number of MyoPro units sold, particularly strong results in international markets as we're starting to benefit from our overseas investments and leveling off in ASP-related growth as the percentage of product revenue we derived from the direct billing channel matures. I'm pleased to report that we've successfully addressed the supply chain issues that arose in the latter part of 2021, while we continue the blocking and tackling that's necessary to support our growth trajectory. As a company, Miomo is focused on two key initiatives, those being pipeline growth and yield improvement. And let me summarize our progress with both. We resumed growth in pipeline additions during the quarter from a combination of new leads generated by our established marketing initiatives, from leads generated by new marketing activities, and from a fully staffed team of intake coordinators and clinicians across the country. At the start of 2022, we enhanced our efforts to diversify our advertising and marketing methods and reduce our use of traditional social media, and those new efforts and new mediums worked well for us during this quarter. Further diversification of our marketing efforts has been implemented this quarter, including our first television ads, which are now running in select markets. These and other previously mentioned initiatives will be ongoing and will expand or undergo modifications as we learn what works best for our business. As we continue to adapt our marketing and patient education strategies within this dynamic online and social media environment to cost-effectively introduce the MyoPro to more prospective candidates, I'm proud of our team's ability to act quickly and thoughtfully to changes in the market and to redeploy our marketing budget to maximize our ROI. To help improve yield, we implemented several new ways of engaging with our patient candidates throughout the sometimes lengthy process of obtaining a myochrome. Late last year, we created the patient navigator role, which is tasked with guiding patients through the authorization process. We're pleased with the initial results from this new function, which we believe helped to reduce our pipeline dropout rate the first quarter compared to the last few quarters. We're optimistic that this role will make a difference in keeping patients motivated as we work to get their MyoPro device authorized by insurance and delivered. Additionally, in insurance appeals, we're emphasizing presentation of the evidence that the MyoPro is not experimental or investigational, and that it is reasonable and necessary which has increased our reimbursement success rate for these patient cases. Now, let's scroll down into a few of the first quarter metrics. We added 358 new patients into our pipeline, which is up 62% from the number added in the previous quarter. During Q4, we were affected by higher social media advertising costs, competition for audience from holiday sales ads, and people's focus on the COVID-19 Omicron variant and other concerns. As we've done in the past, we're adapting to this evolving online marketing environment, and the changes we implemented in the first quarter contributed to this increase in pipeline ads. The combination of new ads plus improved retention led to a total of 924 candidates now in the pipeline. This is a good leading indicator of future orders and revenue growth. Our customer acquisition costs were significantly lower than the first quarters compared to the fourth quarter for a couple of reasons. First, we diversified our advertising and marketing with less emphasis on Facebook, which has become a more costly outlet to advertise on. And secondly, we restructured our customer experience department where our intake coordinators complete phone screens, they verify insurance, schedule telehealth screenings, and with our clinicians, and then help clients through the front end of the process. We now allow that team to work remotely most of the time, and that transition helped us to grow the team and keep up with the demand during Q1, including identifying patients previously on hold that were now ready to resume their journey to obtain a MyoPro. During the first quarter, we received authorizations and orders for 94 units, which is up 42% from the same period a year ago. Historically, we've seen seasonality in our business, with Q1 typically being the slowest quarter of the year for authorizations and orders. Our revenues for the quarter were $3.9 million in total, of which $2.9 million came from 71 MyoPro unit sales, and $1 million was booked for the first payment for the technology license fee from our joint venture partner in China. A topic of interest to many of our shareholders is reimbursement from one of our larger insurance company payers. We continue to receive payments after filing an appeal for the claim after delivery. Importantly, the vast majority of claims for this insurer are continuing to be paid, although an additional step has been added to the process. We also continue to receive preauthorizations from this payer, sometimes requiring an appeals process by a reimbursement specialist to obtain the MyoPro order on behalf of the patient. We've continued to expand and diversify our payer base with several new Medicare Advantage plans, in addition to another state Blue Cross Blue Shield plan covering their first myoprobe in Q1. This paves the way for subsequent approvals for patients with these same health plans. We're actively expanding the number of payers, and as we do so, we expect that the pathway from leave to payment will be easier and faster over time. Since many of our patients are seniors with Medicare Advantage plans, We continue to work with their physicians and payers to obtain reimbursement of their custom MyoPros and expect to be filing claims with the DME Max for Medicare Part B patients in the coming months. Also, we were recently informed that CMS has added discussion of the MyoPro to its public meeting agenda in the second week of June. We intend to take this opportunity to make the case for changing the benefit category determination from DME rental to custom fabricated brace or orthosis. As we've said in the past with respect to CMS, we can't predict the outcome of this meeting as it relates to obtaining coverage and a fee amount for the MyoPro. We also had several new clinical studies published in the first quarter from the Mayo Clinic and the Cleveland VA demonstrating the value of the MyoPro for patients who suffered arm paralysis due to brachial plexus shoulder nerve injury, a stroke, or a traumatic brain injury. These studies add to the growing body of scientific evidence to support medical use of the MyoPro and its reimbursement by government and commercial payers. As I mentioned earlier, the supply chain constraints from the fourth quarter are now behind us. We had a smooth startup of internal manufacturing for the MyoPro2+. Our introduction of the 3D-printed orthotic shells for the MyoPro2+, has gone very well. We've been shipping devices to patients since early February. While we've seen some increases in material costs in the current inflationary environment, we expect to be able to offset those in the second half of the year as we transition more patients to full remote measurements. We believe we're at the forefront in the ONP industry with our use of telehealth for initial patient screenings, with therapist training and online support, and now with the measurement of a patient's arm and hand done remotely. We can immediately transmit the patient's measurements to our 3D component vendor. The streamlined process has helped us keep some of our costs in check. Our international operations performed very well in Q1, representing approximately 23% of our overall revenues. We continue to see strong growth in patient interest, especially in Germany, where we're obtaining reimbursement on a case-by-case basis. We've added to our international staff and believe that this channel represents fertile ground for continued growth, not only in Germany, but in Italy and the U.K. Our joint venture in China is getting closer to becoming operational with receipt of the initial $1 million payment during the first quarter. We expect to receive payment to the remaining licensee before the end of the second quarter, after which we'll begin the process of supporting the JV with training and technology. This training includes working with the staff on how to manufacture and sell the MyoPro devices. Note, however, that the technology transfer is highly selective in retaining key intellectual property in the United States and under our direct control. Now I'll turn the call over to Dave Henry to review our financial results in more detail. I'll come back and provide some additional comments before taking your questions. Dave?