Myomo Inc.

Welcome to the Miami Incorporated Third 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. Now let's turn the call over to Ms. Kim Golodets. Please go ahead.

Thank you, Operator, and good afternoon, everyone. This is Kim Golodets with LHA. Welcome to the MIOMO third quarter of 2022 conference call. Earlier today, MIOMO issued a news release announcing financial results for the three and nine months ended September 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 myomo.com or call LHA in New York at 212-838-3777 and speak with Carolyn Curran. With me on today's call from myomo are Paul Godona, 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 or 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, including the impact of COVID-19. These additional risks, uncertainties, and other factors are discussed in MIOMA's filings with the Securities and Exchange Commission, including the Form 10-Q for the quarter ended September 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, MIOMA undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this call. It's now my pleasure to turn the call over to my OMO CEO, Paul Godona. Paul, please go ahead.

Thank you, Kim, and good afternoon, everyone. Thanks for joining us. Our product revenue for the third quarter of 2022 was $4 million, up 8% sequentially and compared with $4.4 million last year. As I'll discuss, we made continued excellent progress in laying the foundation for solid revenue growth going forward. During our last quarterly call, I highlighted six goals from IOMO in 2022 that were introduced in my shareholder letter from this past spring. Today, I'll summarize our progress against each one of these goals. Our first objective was to accelerate pipeline growth and to do so at a lower cost per pipeline add. In Q3, we had another outstanding quarter of growth in the candidate pipeline with 419 patients moving into the reimbursement process. Year-to-date, we've added more than 1,200 candidates, resulting in a record number of medically qualified patients interested in obtaining a MyoPro to regain motion in their paralyzed arms. With respect to costs, earlier this year, we shifted some of our direct-to-consumer marketing activity away from Facebook to other social media platforms, and we introduced TV advertising. As a result, our cost per pipeline ad has been around $2,500, which is nearly 50% below the peak from just a few quarters ago. Our second goal is to broaden the number of insurance plans covering MyoPro. So far this year, we've added nine new insurance plans such as Blue Cross Blue Shield of Texas and Blue Cross Blue Shield of New Jersey, And in addition, several Medicare Advantage plans covered their first MyoPro this year, which facilitates approvals for future requests on behalf of those plan's beneficiaries. In addition, 10 new VA medical centers have ordered a MyoPro for veterans in their care, increasing the number of VA hospital customers to nearly 70. We obtained a total of about 130 insurance authorizations and orders in the quarter, And if the Q3 average sales price of approximately $45,600, that equates to more than $5.9 million of potential revenue upon delivery and payments. Our orders have increased sequentially each quarter this year in line with the growth of the candidate pipeline, which has served as a really good leading indicator of future revenue. Direct billing represented 79% of our revenue in the quarter, which led to the solid ASP we're reporting. We've had some success in raising the fee charge to payers, and in some cases we've been able to negotiate higher pricing in our single-case agreements to help offset some of the higher costs we have due to inflation. We had 87 revenue units in the quarter, and our backlog is now at a record 184 units, representing over $8 million of potential revenue. Our third goal. is to conduct additional clinical research in order to provide the data to insurers and to CMS if requested in support of a coverage policy. Well, it's been a very good year so far for publishing clinical research in support of the MyoPro. With the Cleveland VA and the Mayo Clinic both publishing outcomes data for patients who have suffered a stroke, traumatic brain injury, or brachial plexus injury, And several other research projects are underway, including a retrospective review of how Medicare beneficiaries have benefited from MyoPro. Fourth, one of my objectives was to use digital technologies to reduce the cost and compress cycle time. Well, at the beginning of the year, we introduced the MyoPro 2 Plus and brought the custom fabrication process in-house, which has given us far more control over the manufacturing process. This new MyoPro model uses 3D printing for the custom shells that fit around the patient's arm. And we developed a remote measurement system that uses a digital camera, tablet, and a telehealth call to measure the patient's arm in their own home. And by shipping a briefcase containing all the electronics directly to the patient, our field clinicians can be far more productive. Plus, we also save money on travel costs. Fifth, we have a goal to expand our international business into new markets. Although we're building off of a small base, our international business has grown nicely this year, especially in Germany, a country with a large population, clinicians and patients who are comfortable with high-tech devices and with good reimbursement by statutory health insurance payers. In addition, we provided a MyoPro to our first patients in Austria, and a few patients in Australia and the UK are benefiting from the MyoPro on a trial basis. In related news, This past summer, we hosted a visit to our Boston headquarters by David Ren, who's the CEO of Riser Medical, our Chinese joint venture partner. He's working with Chinese government officials to forward the remaining $1.7 million license payment to us so that the joint venture can begin operations. As you may be aware, China has suffered new outbreaks of COVID-19, and that has understandably impacted the timing of the payment approvals. So we continue to communicate with our joint venture partners and we're ready to transfer technology and launch the JV upon receipt of the remaining upfront license payments. And our sixth and final goal is to restart development of the MyoPAL device for pediatric patients. Next week, we'll conduct another design testing session with several children with upper extremity paralysis due to cerebral palsy, stroke, and other neurological conditions since birth, and we'll use this input in our product development planning to finalize a schedule for for completing the product design work, doing all the testing, clinical research, and then followed by the commercial launch. And when we do so, the MyoPAL will expand both our market and revenue opportunity. Since last year, we've had a major Medicare Advantage plan approve MyoPros for their beneficiaries and then require us to file an appeal for payment of the claim after the initial post-delivery denial. I'm pleased to report that we've been paid on 120 of these claims, and we continue to receive pre-authorizations for patients with this health insurance plan. And I'll now update you on where we stand with the Centers for Medicare and Medicaid Services, or CMS. Recall that back 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. Well, because codes and coverage requests were made by a number of new high-tech innovators, somewhat similar to MyoPro, although for different indications in other parts of the body, CMS has stated that they need more time to study these products. We are meeting with CMS staff to discuss the MyoPro and the associated research and the value of the patients. And while I can't predict the outcome or timing of these discussions, in the meantime, we're going to continue to focus on the patients that we are serving with Medicare Advantage plans, certain commercial plans, and the veterans covered by the VA. Now we'll turn the call over to Dave Henry to review our Q3 financial results in more detail, and I'll come back and provide some additional comments before taking your questions. Dave?