Myomo Inc.

Good day, and welcome to the MyOMO first quarter 2024 earnings conference call. All participants are 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, press star, then one on your telephone keypad. To withdraw your question, press star, then two. Please note, this event is being recorded. I would now like to turn the conference over to Kim Golodets. Please go ahead.

Thank you, Operator, and good afternoon, everyone. This is Kim Golodets with LHA. Welcome to the MIOMO first quarter 2024 conference call. Earlier this afternoon, MIOMO issued a news release announcing financial results for the three-month standard March 31, 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 filings with the Securities and Exchange Commission, including the Form 10-K for the year ended December 31st, 2023, and subsequent filings. Actual outcomes and results may differ materially from what's expressed in or implied by this forward-looking statement. Except as required by law, MIOMA undertakes no obligation to revise or update any forward-looking statements reflect events or circumstances after the date of this call. It is now my pleasure to turn the call over to MIOMO CEO, Paul Godona. Paul, please go ahead.

Thanks, Kim. Good afternoon, everyone. Thank you for joining us today. Since the beginning of the year, we've benefited from two major developments at the Centers for Medicare and Medicaid Services, or CMS, that have created a significant inflection point for our business. I'll briefly review these policy and pricing actions, discuss how we capitalized on them during the first quarter, and most importantly, how this expanding opportunity to serve individuals with paralyzed arms as we go forward. On January 1st, 2024, the MyoPro was reclassified into the brace category rather than durable medical equipment or DME, which means that our powered arm braces would be covered for medically qualified patients with and would be reimbursed on a lump sum basis rather than a 13-month rental in the DME category. This is consistent with the payment policies for other custom-fabricated orthotics and prosthetics devices that are designed for long-term use in the home. Then on April 1st, the new pricing determined by CMS went into effect with reimbursement for the MyoPro Motion G at $65,872 and the MyoPro Motion W at $33,000 These decisions by CMS open a new world for stroke survivors and others with neurological injury or disease by increasing access to the MyoPro for the many patients enrolled in standard fee-for-service Medicare or Part B. Prior to this clarity on reimbursement, we were not able to provide a MyoPro to traditional Medicare patients, and approximately half of seniors in the United States are covered by standard Part B Medicare. Most of the others are enrolled in a Medicare Advantage plan, but we've had mixed results with the payers. So here's how we are operating our business based on this new Medicare access. To begin with, for the first time ever, we did not have to turn away prospects that had Part B insurance, as we've had to do so for the last 10 years. Instead, we worked with their physicians and therapists to evaluate their medical suitability for the MyoPro and obtain the necessary medical documentation so we could provide a MyoPro to them and submit these claims to Medicare for reimbursement. Second, because the new CMS fee schedule did not go into effect until April 1st, we were able to build a backlog of these Part B patients during the first quarter and to qualify them. As a result, we had a total of 83 qualified patients in the backlog as of March 31st. We expect to be delivering myopros to a large number of these patients in the second quarter. Third, as we recently reported, we've had a quick turnaround on some claims filed since April 1st, but we've been informed that a number have already been authorized for payments. All four DME MAC regions have approved myopro claims and are processing them on a lump sum basis per the published pricing. We're also pleased to learn that one of our own P-Channel partners is also being reimbursed at these rates for their first MyoPro that they delivered to a Medicare Part B patient. And fourth, with the addition of these Part B patients to our addressable market, we've also begun to expand our capacity to serve this larger pool of candidates. As I mentioned during our last quarterly call, we intend to hire 50 to 60 people this year to increase our clinical reimbursement and manufacturing capacity. We've hired approximately 20 professionals through March 31st and are working very hard to achieve this target so we can be in position to double our MyoPro output in the second half of the year. While CMS was finalizing and publishing their reimbursement fees for the MyoPro, our revenue grew 9% over Q1 2023 to $3.8 million. Our expectation was for a slightly higher revenue number, A couple factors affected our results. First, for some Medicare units that were delivered in Q1, the timing of payments was not as expected. Second, the DME Max paid less than the CMS proposed fee on lump sum deliveries made between January 1st, 2024, and March 31st, 2024, which lowered our ASP. And finally, several patient fittings got pushed out into April, and many of these items are expected to self-correct in the second quarter. Overall, the first quarter can be best described as a transition quarter. The DME MAC contractors switched from the rental billing model to lump sum payments, and then the finalization of the new fees occurred at the end of the quarter. While that was happening, we set the stage for strong growth in the second quarter and the rest of the year. We obtained 180 authorizations and orders during the quarter, up 48% from the same period a year ago. And our backlog at the end of the quarter was a record 275 units, which represents myopros that are awaiting delivery to the patient or receipt of the claim payment. This backlog includes these Part B patients, and the overall backlog is up by 56% year over year. We also added a record 493 patients into the pipeline in the quarter, and we ended with over 1,100 candidates in the process of obtaining a myopro up 30% from a year ago. These pipeline and backlog metrics are important leading indicators of revenue growth, and both are up sharply since we can now serve these Medicare Part B patients. I'll now turn the call over to our CFO, Dave Henry, for a deeper dive into the quarterly financials and our recent capital raise, and then I'll return with comments on our business plans for the rest of the year.