Myomo Inc.

Good day, and welcome to the MyOMO Incorporated second quarter 2022 earnings conference call. All participants will be in a 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 touchtone phone. And 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 Ms. Kim Kolodets. Please go ahead, ma'am.

Thank you, Operator, and good afternoon, everyone. This is Kim Galadez with LHA. Welcome to the MIOMO second quarter 2022 conference call. Earlier today, MIOMO issued a news release announcing financial results for the three and six months ended June 30th, 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 miomo.com or call LHA in New York at 212-838-3777 and speak with Carolyn Curran. With me on today's call from MIOMA 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 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-Q for the quarter ended June 30, 2022, 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, MIOMO 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 MIOMO CEO, Paul Godonis. Paul, please go ahead.

Thank you, Kim. Good afternoon, everyone, and thank you for joining us. One of my goals for 2022 is to accelerate MIOMO's momentum in serving the needs of those with upper extremity impairment or paralysis. This population with chronic arm paralysis is significant and growing due to the 800,000 strokes annually just in the United States, many of whom are left unable to use their arms and hands. And this patient population is joined by the thousands of accident victims who are left with arm and hand paralysis. So our adjustable market is significant, it's largely untapped, and it's growing. Since we have strict inclusion and exclusion criteria, not all these individuals are candidates for our MyoPro device. Yet for the first half of this year, we've added nearly 800 medically qualified candidates to our patient pipeline, including a record 420 added during the second quarter. We expect that in 2022, we will add the largest number of candidates to the pipeline in the company's history. And our pipeline is a good indicator of future revenue as we obtain insurance authorizations and deliver MyoPro devices to these patients. Of note, for the first time, we have more than 1,000 candidates in the reimbursement process awaiting approval for their devices. We're educating these patients to the benefits of the MyoPro through a combination of Internet marketing, social media, clinical in-services, clinician referrals, and new advertising on television, which was launched early in the second quarter. By adjusting our media mix, our marketing communications are becoming more cost-effective. We're also diversifying our advertising efforts, and continue to advertise on digital platforms, such as Facebook, which has resulted in lower costs per lead. In fact, our cost per pipeline ad has been cut in half since costs peaked several months ago. At the same time, our lead generation has been growing, which has contributed to the significant increase in our pipeline additions. Once a patient is in the insurance pre-authorization process, our patient advocacy team secures the payment commitment, In the second quarter, we received authorizations with a potential revenue value of $4 million from payers, including orders from VA medical centers and orthotics and prosthetics clinics in the U.S. and overseas. Our team also added to the roster of insurance plans that have now covered their first myopro, such as Blue Cross Blue Shield plans in Texas and Kansas, and new Medicare Advantage plans, such as Highmark, Blue Cross Blue Shield, and several others across the country. We saw an increase in the number of authorizations in the second quarter from a major Medicare Advantage plan that had reduced access for some of their beneficiaries starting late last year. In addition, we saw an accelerated payment cycle with this insurer in the second quarter, and we continue to serve patients covered by this and other Medicare Advantage payers. The direct billing channel represented 83% of our revenue in the quarter, which led to a record average selling price of $46,000 per unit. This AST is a result of the favorable channel mix, as well as our ability to negotiate higher reimbursements in certain cases. Product revenue for the quarter was 3.7 million, which is up 18% from the same period a year ago. We're still waiting for the second license payment from our joint venture in China, which has been delayed due to the COVID-19 outbreak in cities such as Beijing, where our joint venture partner, Riser Medical, is located. Until this payment is received, we're not providing any technology or know-how to support the JV's operational startup. Earlier this year, we began shipping the new MioPro 2 Plus version of our product line. Because this product is custom fabricated in-house, we're reducing our supply chain risk, and we can ramp up production to meet the growing demand. Our international business is largest in Germany, which is a very supportive reimbursement environment through statutory health insurance, which covers about 95% of the population. Our international business added a significant number of new patient candidates into the pipeline as well, and we expect our international revenues to double year over year in 2022. In June, we presented our case at the CMS public hearing to have our benefit category changed from DME rental to a brace or orthosis, which would make the MyoPro available to Medicare Part B patients who don't have access to our device today. I'm pleased with the effort our team put into what I and other industry experts believe was a very compelling case. Our expectation is to receive feedback in the coming months. Though we're confident in what we presented to CMS, we can't predict what the outcome or the timing of our appeal would be. CMS did recently issue a roadmap for states to help connect children with complex medical conditions to critical Medicaid services. While we're still awaiting the details on this program, I'm pleased to see the federal government's increased commitments to specialize healthcare for children with complex conditions. Children with cerebral palsy and other indications which may have resulted in upper extremity impairment could be served by our upcoming MyoPAL pediatric device, and this program may increase access to our technology. We'll be watching for the details of this program to see how it applies to our patient populations. Now I'll turn the call over to Dave Henry to review our Q2 financial results in more detail. Then I'll come back and provide some additional comments before taking your questions. Dave?