Myomo Q1 2024 Earnings Call Transcript

Quartr
Provided by Quartr
May 8, 2024

Key Takeaways

  • On January 1, 2024, the MyoPro was reclassified from durable medical equipment to the custom orthotic brace category, and as of April 1, CMS set lump‐sum reimbursement rates of $65,872 for Motion G and $33,481 for Motion W.
  • For the first time Myomo can serve standard Medicare Part B patients, building a backlog of 83 qualified Part B candidates in Q1 2024 that are expected to convert to deliveries in Q2.
  • Q1 revenue rose 9% to $3.8 million, with authorizations/orders up 48% year-over-year, backlog up 56% to 275 units, and the patient pipeline growing 30% to over 1,100 candidates.
  • Myomo has hired approximately 20 of the planned 50–60 new staff to expand clinical, reimbursement, and manufacturing capacity, aiming to double production to 80–100 devices per month in H2 2024.
  • The company expects Q2 revenue to exceed $5 million, maintains full-year guidance of $28–30 million, and targets quarterly cash-flow breakeven by Q4 2024 assuming no supply disruptions and timely Medicare payments.
AI Generated. May Contain Errors.
Earnings Conference Call
Myomo Q1 2024
00:00 / 00:00

There are 9 speakers on the call.

Operator

Good day, and welcome to the Myomo First Quarter 2024 Earnings Conference Call. All participants are in listen only mode. Please note this event is being recorded. I would now like to turn the conference over to Kim Golodetz. Please go ahead.

Speaker 1

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.

Speaker 1

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 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 ks for the year ended December 31, 2023, and subsequent filings.

Speaker 1

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.

Speaker 2

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 capitalize on them during the Q1 and most importantly, how this expanding opportunity to serve individuals with paralyzed arms as we go forward.

Speaker 2

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 MyoProMotion G at $65,872 and the MyoProMotion W at 33,481. 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 MyoPro to traditional Medicare patients and approximately half of seniors in the United States are covered by standard Part B Medicare.

Speaker 2

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 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 our 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. 2nd, 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 Q1 and to qualify them.

Speaker 2

As a result, we had a total of 83 qualified patients in the backlog as of March 31. We expect to be delivering MyoPro's to a large number of these patients in the Q2. 3rd, as we recently reported, we've had a quick turnaround on some claims filed since April 1, but we've been informed that a number have already been authorized for payments. All 4 Demi 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 O and P channel partners is also being reimbursed at these rates for their first MyoPro that they delivered to a Medicare Part B patient.

Speaker 2

And 4th, 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 31 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 $3,800,000 Our expectation was for a slightly higher revenue number, a couple of factors affected our results. First, for some Medicare units that were delivered in Q1, the timing of payments was not as expected.

Speaker 2

2nd, the DB Max paid less than the CMS proposed fee on lump sum deliveries made between January 1, 2024 and March 31, 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 Q2. Overall, the Q1 can be best described as a transition quarter. The BME MAC contractors switched from the rental billing model, the 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 Q2 and the rest of the year.

Speaker 2

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 MyoPro's that are awaiting delivery to the patients 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 4.93 patients into the pipeline in the quarter and we ended with over 1100 candidates in the process of obtaining 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 D patients.

Speaker 2

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 with comments on our business plans for the rest of the year.

Speaker 3

Thank you, Paul, and good afternoon, everyone. Me start my remarks with a review of our Q1 financial results. Revenue for the Q1 of 2024 was 3,800,000 dollars This consists 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 Q1, offset by a lower average selling price or ASP. Revenue came in somewhat lower than our guidance due to push out to 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 fees.

Speaker 3

The payments that pushed out are expected during the Q2. Revenue in the Q1 includes payments received on 17 Medicare lump sum Part B claims from deliveries after January 1, 2024. All of these paid claims were underpayments compared to the final fees posted by CMS, which became effective as of April 1, 20 24. These payments lowered the ASP in the Q1 to approximately 41,300, which was down 5% versus the prior year quarter. As we announced earlier in the week, we've 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.

Speaker 3

Of the 91 revenue units in the Q1 approximately 29% resulted from fill which is our term Q1 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 Q1, we were more reliant on payments from insurers to record revenue than in prior quarters. Of our direct billing revenue, 54% was from patients with payers where we are able to recognize revenue at delivery compared with 70% in the year ago quarter. That equates to a 29% year over year decrease in revenue from these payers, which were primarily from Medicare Advantage Payers in the Q1 of 2024 compared to the Q1 of 2023.

Speaker 3

We're seeing a slowing in growth of authorizations from Medicare Advantage Plans. Some of this is due to reorienting our clinical capacity for Medicare Part B patients which began in the Q4 of 2023 and some may be due to utilization management efforts newly published to see if the newly published fees by CMS increases Medicare Advantage authorizations since these plans are now required to cover the MyoPro so long as medical necessity can be established. In the Q1 of 2024, we continued efforts to fill the pipeline and backlog with Medicare Part B patients as the published fees are now effective. Reported backlog now represents insurance authorizations and orders received but not yet converted to revenue. And in the case of Medicare patients, those patients for whom we've collected medical records and being record 270 5 patients, which was up 56% from our backlog at the end of Q1 2023.

Speaker 3

This ending first quarter qualified for the delivery with appropriate medical documentation or received a MyoPro and claims have been filed, but payment has not yet been received. These additional Part B patients added to the backlog contributed to 1 180 authorizations orders and other additions to the backlog in the Q1, which was up 48% over the prior year quarter. Our patient pipeline increased to 11 12 candidates as of March 31, 2024, up 30% from a year ago. A record 4.93 patients were added to our pipeline during the Q4 for the Q1 I should say, an increase of 12% over the prior year. Our pipeline of Medicare patients increased to approximately 230 at the end of the Q1.

Speaker 3

Gross margin for the Q1 of 2024 was 61.2% compared with 67% for the prior year quarter. The decrease was driven primarily by lower ASP and some cost increases including materials offset by lower royalty expense as the MIT license expired in November 2023. Operating expenses for the Q1 of 2024 were $6,200,000 an increase of 24% compared with the Q1 of 2023. This increase was driven primarily by higher headcount as we are adding clinical and reimbursement capacity in order to grow revenue in the second half of the year. Higher engineering headcount and outside development spending to accelerate completion of certain sustaining engineering projects and higher advertising expense.

Speaker 3

Our cost per pipeline ad was $15.97 which is up 1% compared with the prior year quarter and down 29% sequentially. The operating loss for Q1 of 2024 was $3,900,000 compared with an operating loss of $2,700,000 for the Q1 of 2023. Net loss for the Q1 of 2024 was $3,800,000 or $0.10 per share. This compares with a net loss of $2,600,000 or $0.11 per share for the Q1 of 2023. Operating and net losses increased year over year due primarily to added headcount to increase clinical reimbursement and manufacturing capacity in advance of the revenue growth we expect later in 2024.

Speaker 3

Note that the $8,500,000 pre funded warrants outstanding from our offerings in 2023 January 2024 are considered common stock equivalents under GAAP and are included in our weighted average shares outstanding. Adjusted EBITDA for the Q1 of 2024 was a negative $3,500,000 compared with a negative $2,500,000 for the first quarter of 2023. Turning now to our cash position, cash, cash equivalents and short term investments as of March 31, 2024 or $11,000,000 Cash used in operating activities was $3,200,000 for the Q1 of 2024 compared with $1,800,000 for the Q1 of 2023. We completed a registered direct offering in January 2024, generating net proceeds to Myomo of approximately $5,400,000 We believe our cash is sufficient to fund our operations for at least the next 12 months from today. I'll close my comments with a review of our financial guidance.

Speaker 3

Given our backlog, we believe we're positioned to generate in excess of $5,000,000 of revenue in the Q2. Recall that in the near term Medicare patient revenues will be recorded at the time of payment until sufficient collection history is established. We continue to expect gross margin pressure in the Q2 of 2024 as we ramp up deliveries to Medicare patients recording cost of goods sold at that time, while recording revenue and payment. Cash used for operations is expected to be higher in the second quarter due to 2023 incentive compensation payments is expected to be lower in the second half of twenty twenty four. We continue to believe that both full year 2024 revenue of $28,000,000 to $30,000,000 and our target of cash flow breakeven on a quarterly basis by the Q4 of 2024 are achievable assuming we have the required clinical reimbursement and manufacturing capacity by the end of the second quarter there were no supply chain disruptions or other unusual events.

Speaker 3

With that financial overview, I'll turn the call back to Paul.

Speaker 2

Thanks, Dave. While looking ahead, we plan to increase the number of qualified patients entering our pipeline since we can now engage with Part D 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 and P partners has also received payments, we have seen a significant increase in interest O and P clinics to provide the MyoPro to patients in their practices. Only 4% of our product revenue came from U. S.

Speaker 2

O and P channel partners in calendar year 2023. We are building our program to recruit, train, certify and support these clinicians who 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 OMP 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 had been reluctant to cover the MyoPro in the past since these payers are required to cover Medicare covers so long as the patient meets the medical necessity and inclusionexclusion criteria. Many of these Medicare Advantage operators are under increasing scrutiny for refusing to pre authorize medical procedures and we will be engaging with them to enact more favorable coverage policies for the MyoPro.

Speaker 2

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 OT World Conference in Germany this month to assist our team in recruiting additional OMP 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

Thank you. We'll begin the question and answer session.

Speaker 2

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

Operator

Thank you. Our first question today comes from Scott Henry with AGP.

Speaker 4

Thank you and good afternoon. 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?

Speaker 4

Is that sustainable? I know sometimes you get a little stronger number in the Q1 or do you think you expect it to grow near term?

Speaker 2

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.

Speaker 4

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

Speaker 3

Sorry, Scott. We're not just as a reminder, we're not increasing our advertising spending because we are 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 you should expect that cost per pipeline add to continue to come down.

Speaker 4

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

Speaker 2

Well, we always screen patients for their insurance coverage. And we've had to turn away people who had payers where such as most of them state Medicaid plans, for example, certain Medicare Advantage plans, which were recalcitrants and were 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 thirds of strokes happen to people aged 65 and older. So we've got a significant increase in our adjustable market with now that we can serve Part B.

Speaker 4

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 Q1, Would you expect that rate to increase over time because of the standardized reimbursement or clearer reimbursement?

Speaker 3

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 of 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.

Speaker 4

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?

Speaker 3

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've said that Medicare for the payments that we've received in April, on deliveries made in April, they were made at the published fees and in accordance with those published fees. So if we're getting, call it, $50,000 $51,000 for each of those and our average ASP has been in the range of 42, Medicare will continue to be a larger part of our revenues going forward. And so that should result in a higher ASP.

Speaker 3

I think an ASP somewhere mid to high 40s is where we should land on as we as the beat of the business takes hold in terms of our ultimate mix between Medicare and Medicare Advantage and others.

Speaker 4

Okay, great. Thank you for taking the questions.

Speaker 2

Sure.

Operator

Thank you. Our next question comes from Anthony Vendetti with Maxim Group.

Speaker 3

Thanks.

Speaker 5

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? Are you looking at additional manufacturing facilities?

Speaker 5

What would you consider using a contract manufacturer outside the organization?

Speaker 2

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 $10,000,000 revenue quarter. So for us, it's a very asset light type of manufacturing.

Speaker 2

We subcontract out the robotic motor unit kits. We subcontract out the 3 d printing of the orthotic shells 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 front end from the intake coordinators, reimbursement staff and fitting staff, we're also expanding those positions as well.

Speaker 3

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 patients in the pipeline and those pipeline adds sort of ranged and they were maybe in the range of $380,000,000 to $430,000,000 for most of 2023 and so we exceeded that in the Q1. And as Paul mentioned, we're looking to add capacity continue to add capacity to increase those adds to the pipeline in coming quarters.

Speaker 5

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 timeframe? Will you be at that run rate by the end of the year 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?

Speaker 2

Well, we're hiring people now. We're training them so that by Q4, we're at that 80 to 100 unit run rate. Our contractors, we've 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.

Speaker 2

So, we continue to plan to expand capacity and revenue going forward here as well.

Speaker 5

Okay. And then just lastly on the guidance still $28,000,000 to $30,000,000 So as you mentioned, some of the reasons, 1st quarter was a little bit light, But it sounds like that whatever that you were light in the Q1 got pushed into the Q2, but you believe that revenue will materialize in the Q2 and continue to have confidence in the pipeline for the remainder of the year, correct?

Speaker 3

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 Q1 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 held off on them until Q2. So those should come through.

Operator

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

Speaker 6

Good afternoon, guys, and thanks for taking my questions. My first one is on the sales cycle. So as we mentioned in the prepared remarks, quite a few of the orders during the Q1 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?

Speaker 2

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 pre authorization 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 and a suitable candidate, they can go to their physician. Let's say, it takes them a month or 2 to get the medical documentation you 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.

Speaker 2

So that's where we're compressing that revenue cycle by having these Part B patients now as part of our marketing target.

Speaker 6

Great. Thanks for that. My second question is on the proportion of the device types that you are seeing from these Medicare patients. Are you I think previously you mentioned there was the mix of 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?

Speaker 2

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

Speaker 3

product lines. Yes. Overall, it's probably between 90% 95% Motion G.

Speaker 6

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

Speaker 3

gain? Yes, I mentioned that to clarify, I mentioned that the 2nd 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, is 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 and that will fix itself.

Speaker 3

And so then longer term, I would expect that we should be able to get to gross margins in the 70 percent range.

Speaker 6

Thank you. That's all I have.

Speaker 3

All right. Thank you.

Operator

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

Speaker 7

Good afternoon, gentlemen. Thanks for taking the questions. 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?

Speaker 2

Yes, Ben, that's a very good point because the longer that cycle extends, more chances that a 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 authorizations has ranged certainly in the 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.

Speaker 7

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 to the line that you have their contact information from previous leads?

Speaker 2

Yes. These people are in our CRM system and we're following it by 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 team to be able to reach out to those patients that may be eligible for MyoPro. That's why we're hiring these people right now.

Speaker 3

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.

Speaker 7

Okay, got it. So then is the right way to think about it, if a good whatever the portion

Speaker 6

of

Speaker 7

Medicare Non Part B patients that entered 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?

Speaker 2

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

Speaker 7

Okay, got it. And then lastly for me, just with the U. S. O and 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?

Speaker 7

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?

Speaker 2

Yes. I think it could be a significant part of our business just because there are about 3,000 of these O and P clinical offices around the country. Now, not all of them specialize in upper extremity or myoelectric devices like this, but there's certainly been keen interest at the various O and 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 and P channel start to kick in for the latter part of the year and then start to grow next year and the years beyond.

Speaker 2

But it could be the majority of our business over time.

Speaker 3

And we don't think that the growth in the OMP channel that we realize will really significantly degrade what we're doing on as our being our own direct provider to patients because we when we do our advertising, we're primarily advertising towards people that are in that population of people that have had their stroke probably years ago. They're out of the healthcare system for their stroke, whereas the O and 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 whom we're been 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 and P channel, there should be incremental growth and not be substituted by a corresponding decrease in

Speaker 7

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

Speaker 3

We have been, yes.

Speaker 7

Got it. Okay, great. Well, thanks for taking the questions, gentlemen, and congrats on the progress.

Operator

Our next question comes from Edward Woo with Ascendiant Capital.

Speaker 8

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?

Speaker 8

And can you talk about the overall market opportunities on how much more growth can there be in this channel?

Speaker 2

Sure. I'll speak to Germany specifically because that's our best international market at this time. It's got a significant population over 80,000,000, good economy, they like high-tech products. And we have developed a network of O and P channel partners over 100 different locations now. So our clinical team goes in there, trains them.

Speaker 2

These O and 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 and P channel, and that's what's now growing the business there in Germany.

Speaker 2

So we've said we're going to be 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.

Speaker 8

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

Speaker 2

Yes. It's been 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 D patients.

Speaker 8

Great. Well, thank you and good luck.

Speaker 2

Thanks. Thanks,

Operator

guys. 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.

Speaker 2

Well, 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 resources necessary to serve this larger pool of potential MyoPro candidates and we're also increasing our R and D investment to build upon our market leading position.

Speaker 2

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.

Operator

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

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