Good day, and welcome to the Myomo First Quarter 2024 Earnings Conference Call. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Kim Golodetz. Please go ahead.

Thank you, operator, and good afternoon, everyone. This is Kim Golodetz with LHA. Welcome to the Myomo First Quarter 2024 Conference Call. Earlier this afternoon, Myomo issued a news release announcing financial results for the 3 months ended March 31, 2024. If you would like to be added to the company's e-mail 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 Gudonis, 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 Myomo's business, financial condition and operating results. These additional risks, uncertainties and other factors are discussed in Myomo's filings with the Securities and Exchange Commission, including the Form 10-K for the year ended December 31, 2023, 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's CEO, Paul Gudonis. 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 2 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 1, 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 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 1, 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 $33,481. These decisions by CMS opened 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 are 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 where 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 do not have to turn away prospects that…

Thank you, Paul, and good afternoon, everyone. Let me start my remarks with a review of our first quarter financial results. Revenue for the first quarter of 2024 was $3.8 million. This consisted entirely of product revenue and was up 9% over the prior year quarter. This growth was driven by a higher number of revenue units, which were up 14% over the 2023 first quarter, offset by a lower average selling price or ASP. Revenue came in somewhat lower than our guidance due to pushouts of some deliveries, payments that had been forecasted, which did not come in and other payments from CMS on pre-April claims that were lower than the published ease. The payments that pushed out are expected during the second quarter. Revenue in the first quarter includes payments received on 17 Medicare lump sum Part B claims from deliveries after January 1, 2024. All of these paid claims were under payments compared to the final fees posted by CMS, which became effective as of April 1, 2024. These payments lowered the ASP in the first quarter to approximately 41,300, which was down 5% versus the prior year quarter. As we announced earlier in the week, we received remittances from all 4 DME MAC regions for payments for MyoPro deliveries made after April 1, 2024, that are in line with the published fee schedule. Of the 91 revenue units in the first quarter, approximately 29% resulted from fill, which is our term for authorizations and orders received and converted to revenue in the same quarter. 59% of our revenue in the first quarter came from the direct billing channel compared with 69% in the same quarter a year ago. Of note, a record 25% of first quarter revenue came from international locations, primarily Germany. In the first…

Thanks, Dave. While looking ahead, we plan to increase the number of qualified patients entering our pipeline since we can now engage with Part B beneficiaries, which should lead to accelerated revenue growth as we obtain the necessary physician orders and the supporting medical documentation. Since CMS published these new fees and one of our O&P partners has also received payments, we have seen a significant increase in interest from O&P clinics to provide the MyoPros to patients in their practices. Only 4% of our product revenue came from U.S. O&P channel partners in calendar year 2023, and we are building our program to recruit, train, certify and support these clinicians. We already see a large number of stroke patients for other braces such as an ankle foot orthosis or AFO. With reimbursement clarity, we expect that these O&P providers will become a much larger percentage of our business even as we invest in expanding our own in-house direct provider and billing operations. We've also started to submit claims to those Medicare Advantage plans that have been reluctant to cover the MyoPro in the past since these payers are required to cover Medicare covers the long as the patient meets the medical necessity and inclusion exclusion criteria. Many of these Medicare Advantage operators are under increasing scrutiny for refusing to preauthorized medical procedures, and we will be engaging with them to enact more favorable coverage policies for the MyoPro. We also expect continued growth in our international business as we expand our European team and the China joint venture begins production and sales. In fact, I'll be attending the influential OTWorld Conference in Germany this month, to assist our team in recruiting additional O&P partners to our distribution network. So with that update and overview of our plans for the rest of 2024, we're now ready to take your questions. Operator?

[Operator Instructions]

Before we turn to your questions, I just want to mention that we will be attending the Alliance Global Partners Virtual Healthcare showcase on May 21, and the Sidoti Small Cap Virtual Conference on June 12 and 13, and we're also available for virtual and in-person investor meeting, so please contact LHA Investor Relations to set up the time. So operator, we're ready now for the questions.

Our first question today comes from Scott Henry with AGP.

Exciting time for you guys. I guess I'll start with the top of the funnel. 493 is a big number for pipeline adds in Q1. How should we think about that number going forward? Is that sustainable? I know sometimes you get a little stronger number in the Q1? Or do you think you'd expect it to grow near term?

Thanks, Scott. We expect that pipeline growth number to increase as we add more capacity. We're hiring intake coordinators, more people in our reimbursement and clinical staff. So we should see an increase in that pipeline additions over time because now we can actually engage with these Part B patients who in the past I had to say, sorry, can't serve you.

Yes. And just -- which I guess spring makes it a lot more efficient. And as you commented, brings down that cost per pipeline add. In the past...

Yes, and we're not -- sorry, Scott -- we're not -- just as a reminder, we're not increasing our advertising spending because we're already generating, I think, sufficient leads given the fact that we were setting aside all those Medicare Part B patients, now we're able to start to engage with them. So that's why I should expect that cost per pipeline add to continue to come down.

Okay. And just thinking to prior quarters, you used to have to turn away some patients because of their provider or the classification. How many patients do you currently have to turn away versus who you previously had to -- how should we think about that?

Well, we always screen patients for their insurance coverage. And we've hadn't turned away people who had payers where such as most of the state Medicaid plans, for example, certain Medicare Advantage plans, which were recalcitrant and we're denying this coverage for their beneficiaries. So we can now engage with some of those plans. In addition, remember, half of the seniors are on Medicare Part B. 2/3 of strokes happen in people aged 65 and older. So we've got a significant increase in our addressable market with now that we can serve Part B.

Okay. Great. Now just a couple of quick questions. When we look at the model going from the pipeline adds to the backlog, there's that authorization percent which you said declined a little bit sequentially. Would you expect -- I mean, it would seem that with more definitive reimbursement that I think it was 16% in first quarter. Would you expect that rate to increase over time because of the standardized reimbursement or clearer reimbursement?

I would expect that -- as we move forward, the velocity of things that go through the pipeline into the backlog will increase. And so I think that will end up -- that could end up actually holding down the pipeline at the ends of quarters and things like that because there's a faster amount of patients that are moving through, particularly the Medicare patients. But if those people are moving through because they turn into authorizations, then that percentage that you're talking about should continue to tick up over time.

Okay. Great. And final question. The CMS rate for reimbursement was pretty strong relative to what you're currently realizing for price. Forgetting about the noise short term, long term, should we expect to see price increase given that reimbursement rates are perhaps higher than the current price out there?

Yes. I mean -- so the allowable for the highest selling product of Motion-G is almost $66,000. Medicare will pay 80% of that. And we said that Medicare for the payments that we've received in April, on deliveries made in April, they were made at the published fees in accordance with those published fees. So we're getting, call it, $50,000, $51,000 for each of those, and our average ASP has been in the range of $42,000. Medicare will continue to be a larger part of our revenues going forward. And so that should result in a higher ASP. I think an ASP, somewhere mid to high 40s is where we should land on a -- as we -- as the beat of the business takes hold in terms of our ultimate mix between Medicare and Medicare Advantage and others.

Our next question comes from Anthony Vendetti with Maxim Group.

So some of the questions have been answered. But in terms of the capacity, as you ramp up now with the greater demand as the backlog grows, can you just remind us what your manufacturing capacity is? How many of these devices can you manufacture per year? And do you have the ability to increase that capacity at the current site? Or are you looking at additional manufacturing facilities? What would you consider using the contract manufacturer outside the organization?

Yes. Hi Anthony, it's Paul. So we do the final assembly and inspection here. And we've been averaging about 40 to 50 units per month. And our plan is to double that to 80 to 100 units per month Q3, Q4 so that we can get to that $10 million revenue quarter. So for us, it's a very asset-light type of manufacturing. We subcontract out the robotic motor unit kits. We subcontract out the 3D printing of the orthotic shelves, and we do the hands-on assembly work here at our current facility. We've been using more space here in the building for manufacturing, and we are looking at other sites so that we can continue to expand that manufacturing. And along the way, too, we're also that frontend from the intake coordinators of reimbursement staff and fitting staff, we're also expanding those positions as well.

And you saw some results from that capacity increase in terms of our pipeline as in the first quarter. We had some additional ability to take on more of that volume. And so that resulted in -- we had a record number of pipeline as last year, we were kind of what I would say, capped in terms of our capacity to add pages in the pipeline and those pipeline adds sort of ranged and they were maybe in the range of 380 to 430 for most of 2023. And so we exceeded that in the first quarter. And as Paul mentioned, we're looking to add -- continue to add capacity to increase those adds to the pipeline in coming quarters.

Okay. And so you're doing about 40 to 50 units per month now, you're looking to get to 80 to 100. When -- what's the time frame? Will you be at that run rate by the end of the year or sooner than that? And then in terms of looking to expand beyond that, are you having negotiations with other contract manufacturers or other ways to get to that number above and beyond 80 to 100 a month, if the demand is there for that?

Well, we're hiring people now. We're training them so that by fourth quarter, we're at that 80 to 100 unit run rate. Our contractors have engaged with them with our supply chain managers. They can handle the increased volume. We've placed orders for those long lead time components such as motors and so on. So we continue to plan to expand capacity and revenue going forward here as well.

Okay. And then just lastly on the guidance, still $28 million to $30 million. So as you mentioned, some of the reasons first quarter was a little bit light. But it sounds like that whatever that you were like in the first quarter got pushed into the second quarter, but you believe that revenue will materialize in the second quarter and continue to have confidence in the pipeline for the remainder of the year, correct?

Yes. I think in some cases, we said much of that will come across. I think I don't know how easy it will be, for example, to get additional payments from CMS on some of those underpayments we got in the first quarter, that could be a bit of a slog. But other than that, for things that -- for payments we expected to come in that didn't and for deliveries we expected to make, but we held off of them until second quarter and those should come through.

Our next question comes from Sean Lee with H.C. Wainwright.

My first one is on the sales cycle. So as you mentioned in the prepared remarks, quite a few of the orders in the first quarter came in and were filled in the same quarter. So I was wondering with additional Medicare patients coming in, do you expect that proportion to grow?

So we expect, again, more Medicare Part B patients to be a greater proportion of the pipeline as Dave mentioned, there's a higher velocity with those patients because there's no need to go through a preauthorization process like we have to do with commercial and Medicare Advantage plans. So that can add 30 to 180 days of delay before an authorization. So if we can evaluate a Medicare patient today, they're suitable candidates, they can go to their physician, let's say, it takes them a month or two to get the medical documentation, they submit it to us. We review it. We can immediately place an order with our operations to develop and build a device for them and fulfill it. So that's where we're compressing that revenue cycle by having these Part B patients now as part of our marketing target.

Great. My second question is on the proportion of the device types that you're seeing from these Medicare patients. Are you -- I think previously you mentioned there is the mix was something like 90 to 10 for Model-G versus Model-W. I was wondering now that you have quite a few of these orders coming in, do you still see the same proportion?

Yes. I mean, it really isn't that distinctive by Medicare or Medicare Advantage coverage. So yes, that's a pretty good mix of product line.

Yes. Overall, it's probably between 90% and 95% Motion-G.

Okay. Great. And my last question is on the gross margin. So you mentioned we expect to see a bit more pressure this year due to expansion -- sorry, production expansions. So I was wondering, looking a bit further ahead and with the Medicare payments coming in more steady, where do you see the gross margin to end up being?

Yes, I mentioned that -- to clarify, I mentioned that the second quarter gross margin could see pressure because of the fact that we are accelerating the -- there's a dislocation between -- until we develop sufficient collection history with Medicare, there's a dislocation between when we record cost of goods sold and when we take revenue. We take cost of goods sold to delivery, and we wait till payment to take revenue. And so there could be -- what my expectation is that at the end of the second quarter, there's going to be units delivered but unpaid for Medicare patients, and that will hold down the gross margin. But that will correct itself later in the year, as I expect that we'll be able to switch to being able to record revenue at delivery for Medicare patients, and that will fix itself. And so then longer term, I would expect that we should be able to get to gross margins in the 70% range.

And our next question comes from Ben Haynor with Lake Street Capital Markets.

First off for me, on the increased velocity that you're going to see from pipeline to authorization to delivery, does that automatically kind of improve the pipeline quality in that there's less time or less opportunity for patients to drop out as well.

Yes, Ben, that's a very good point because the longer that cycle extends, more chances that a patient will change insurance. Some of them suffer another medical issue like another stroke. Also, with the pipeline quality being more Part Bs we're not that dependent on these pre-authorizations because we said in the past, our success rate on the Medicare Advantage pre-authorization has ranged simply in that 40% to 50% of those pipeline adds. So having Part Bs, which are medically qualified, we'll have a much higher success rate of turning those into actual deliveries.

Got it. That's helpful. And then on the Part Bs that you've had to turn away historically, have you undertaken much activity to try and sort of, I guess, reactivate and add some of those folks in the pipeline that you have their contact information from previous leads.

Yes, these people are in our CRM system. And we're following Medicare regulations as far as how far back you can go out to reach out to them. I'm trying to reach out to them. I've got to add more people in my clinical and call center teams to be able to reach all those patients that may be eligible for MyoPro. That's why we're hiring these people right now.

Under Medicare regulations, we have 15 months to reach back and to be able to contact those people again. So we have some time here.

Okay. Got it. So then is the right way to think about it is a good -- whatever the portion of Medicare non-Part B patients that enter the pipeline, you kind of double that figure over the last 15 months, and that gets you roughly to what the number of folks that you could be contacting, if that makes sense.

Well, given that our addressable market has doubled because of these Part D patients, assuming we can evaluate all those patients and get them into the pipeline. Yes, that pipeline should increase again over time.

Okay. Got it. And then lastly for me, just with the U.S. O&P channel being 4% last year with this year being a bit of a kind of transition year and getting people back engaged on that channel. What do you think that, that could ultimately look like over time, whether it's a year from now or even several years from now, is that going to be a third of your business, half of your business, what does that look like in terms of U.S. revenues?

I think it could be a significant part of our business just because there are 3,000 of these O&P clinical offices around the country and not all of those specialized in upper extremity or myoelectric devices like this, but there's certainly been keen interest at the various O&P conferences we've already been to. We're already planning a schedule of classes to certify these CPOs later this year. So I think we'll see the O&P channel start to kick in for the latter part of the year and then start to grow next year and the years beyond. But it could be the majority of our business over time.

And we don't think that the growth in the O&P channel that we realize will really significantly degrade what we're doing on -- as our -- being our own direct provider to patients because -- so we -- when we do our advertising, we're primarily advertising towards people that are in that population of people that had their stroke probably years ago. They're out of the healthcare system for their stroke. Whereas the O&P channel are seeing people that are a bit more recent, soon after they've had their stroke. And so, it's a different type of people that they're seeing as opposed to who we're being advertising to. And so that's why we think that a good portion of the growth that we expect to experience going forward in the O&P channel there should be incremental growth and not being substituted by a corresponding decrease in direct billing.

Okay. That makes sense. So you guys are going more after the prevalence group rather than the incidence group.

We have been, yes.

Congrats on the progress.

[Operator Instructions] Our next question comes from Edward Woo with Ascendiant Capital.

Yes. Congratulations on the quarter and definitely congratulations on your international growth again. Can you talk about what you were doing there that's maybe different or the same as in the U.S. to be able to have that momentum? And can you talk about the overall market opportunities on how much more growth can there be in this channel?

Sure. Well, I'll speak to Germany specifically because that's our best international market at this time. It's got a significant population, over 80 million, good economy. They like high-tech products. And we have developed a network of O&P channel partners, over 100 different locations now. So our clinical team goes in there, trains them. These O&P providers see the patients. They work with the insurance companies that they already are contracted with. So that approach is working. Also we're using social media there to generate demand. But I think it may be a good example of what you can do through an O&P channel. And that's what's growing the business there in Germany. So we've said we're doubling down. We're basically putting more resources, hiring more people in Germany because, again, that's a big untapped market opportunity. And then we'll see over time we may enter into other selected markets based on the reimbursement environment there.

Great. So the population, almost of 20% of the U.S., do you think the market there can reach about 20% of the size that you expect in the U.S.?

Yes. It could very much do so. In fact, it was 25% of our revenue in this first quarter, but now we'll see accelerated U.S. revenue with the addition of the Part B patients.

Thank you. This concludes our question-and-answer session. I would like to turn the conference back over to Paul Gudonis for any closing remarks.

Thank you, operator. As you all know, we've had a long journey to establish these reimbursement policies and pricing for the standard Medicare Part B patient population. It's very gratifying to see these patients have the same equitable access as other patients with other health insurance plans. At a recent fitting of a MyoPro for a stroke survivor, her husband said, "Thank God for Medicare because a year ago, we just couldn't get this device for her." As we discussed today, we're investing in the resources necessary to serve this larger pool of potential MyoPro candidates and we're also increasing our R&D investments and build upon our market-leading position. So with growth in volume and revenues, we can achieve our target of cash flow breakeven on a quarterly basis by the end of the year, if we're able to add the expanded delivery capacity as we planned, and Medicare reimbursement continues on a timely basis. These actions will also position us well as we head toward a much larger profitable company addressing this large unmet medical need and improving the lives of many more patients in selected markets worldwide. So thank you for your participation today, and have a good evening, everyone.

Thank you. The conference has concluded. Thank you for attending today's presentation.