Myomo, Inc.
Q4 2021 Earnings Call Transcript

Published: 9 Mar 2022

[Operator:]

And welcome to the Myomo Fourth Quarter 2021 Earnings Conference Call. All participants will be in listen-only mode. Should you need assistance, ? After today's presentation, there will be an opportunity to ask questions. . Please note this event is being recorded. I would now like to turn the conference over to Kim Golodetz. Please go ahead.

[Kim Golodetz:]

Thank you, Operator, and good afternoon, everyone. This is Kim Golodetz with LHA. Welcome to the Myomo fourth-quarter 2021 financial results conference call. Earlier today, Myomo issued a news release announcing financial results for the three months and fiscal year ended December 31, 2021. 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 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, including the impact of the ongoing COVID-19 pandemic. These and additional risks, uncertainties, and other factors had discussed in the risk factors and other qualifications contained in Myomo's filings with the Securities and Exchange Commission, including the Form 10-K for the year ended December 31st, 2021, which is expected to be filed shortly. 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. And is now my pleasure to turn the call over to Myomo CEO, Paul Gudonis. Paul, please go ahead.

[Paul Gudonis:]

Thank you, Kim. Good afternoon, everyone, and thank you for joining us. After I provide a business update, Dave will review our fourth quarter and full-year financial results and discuss our financial outlook, and following the financial update, I'll give some closing remarks and then we'll take your questions. During our last call in mid-November, while we were delighted with our third quarter financial results, I flagged a few short-term issues that were impacting the fourth quarter. I mentioned that we were dealing with some supply chain challenges as well as unexpected post-delivery claim denials by one of our larger payers. I'm very pleased that despite these issues, we generated $4 million of revenue in the fourth quarter of 2021, which was up 6 % from a year ago, and in addition, for all of 2021, our revenues were $13.9 million up a substantial 83 % from the prior year while operating throughout the second year of the COVID-19 pandemic. I'm also pleased to report that we have resolved the supply chain issues, thus enabling us to enter 2022 with the ability to continue to grow our revenues and deliver MyoPro devices to a larger number of patients this year. Our fabrication contractor, GRE, was able to hire and train new technicians, so shipments returned to normal levels by December, which will lead to 2022 revenues as insurance payments are booked. We also announced in January the introduction of the next version of our primary product line, the MyoPro 2 +. The 2 + includes custom 3D printing of the orthodic components, and we also began in-house assembly of the units at our facility here in Boston, thus reducing our reliance on outside suppliers, and we delivered the initial MyoPro 2 + units to patients in early February. With respect to reimbursement, you may recall that we had a development with one of our larger insurance payers. This payer began denying claim payments despite the receipt of pre -authorizations and the deliveries of MyoPros to their covered benefit. This payer then upon review of the MyoPro, like a lot of new innovative medical devices, they still considered experimental and investigational. Although we have written testimony which contradicts this position, along with substantial clinical research and industry experience with myoelectric technology, they've told us that the denial of claims is part of a temporary internal monitoring process, but we do not have a timeline anyone of this will be discontinued. Since this change began in late September, we've been paid on the vast majority of more than 50 bona fide claims after successful appeals and only four appeals have been denied. However, we are confident that these and to these patients. So right now is business as usual for patients covered by this payer, except that we must take that initial additional step in order to get paid. We're pleased that during the last year we added a significant number of new payers, including Medicare advantage plans, commercial plans, and several state Medicaid plans which cover their first MyoPro. And in Germany, MyoPro coverage continues to expand with more payers covering the device for their beneficiaries on a case-by-case basis. Overall, we had a record year of MyoPro approved by the patient's health insurance plans in 2021. Our candidate pipeline which was 808 at December 31st, did not increase sequentially during the fourth quarter, and I believe several factors came into play. Because of the greater competition for social media audiences during the holiday shopping season, the price for online ads went up, and we decided not to spend additional advertising dollars to generate the same lead flow. This impacted our costs for pipeline ad, which approached $5,000 in the fourth quarter. Instead, we are increasing advertising spend in the first quarter now, when online competition is typically dropped off, so that we get more bank for our buck. We also found that in Q4, patients and their families are more focused on the holiday season than on exploring a new medical treatment, a pattern we also saw in the fourth quarter of previous years. In addition, we saw more candidates dropout or go on hold, possibly due to the spike in COVID cases caused by the Omnicron variance that erupted late last year, thus postponing their interest in our MyoPro. These behaviors resulted in fewer patient leads completing evaluations and a greater number of dropouts during the preauthorization process. And lastly, we are consciously allocating our reimbursement resources toward patient cases and appeals where we believe the prospect of winning authorization is highest. Unfortunately, that means having to tell some patients we won't be able to service them at this time, resulting in dropping them from our pipeline. So as we enter 2022, we've ramped up our online advertising and we move more new patient prospects into our pipeline with just over 200 new candidates added in the first two months of this quarter, at amount approximately the total number added for all the fourth quarter of 2021. And our expectation is for a lower cost per pipeline ad in the first quarter compared to the fourth quarter. In Q4, we recorded revenue on a record 107 units and received authorizations and orders for 104 new MyoPros. Direct billing represented 73 % of total revenues in the quarter, reflecting higher sales from the VA and orthodics prosthetic channels in the United States and from international markets, as we prioritize deliveries we were able to complete in the fourth quarter, given the supply chain constraints toward channels where we would recognize revenue upon delivery. Our international operations represent approximately 10 % of our overall revenues, and we're seeing strong growth in patient interest, especially in Germany. And we've been successful, we're now having 52 % of the German population covered by insurance plans that are reimbursed for one or more MyoPros on a case-by-case basis. With respect to our China -based business, we negotiated some changes to our joint venture agreement with Ryzur Medical, which will increase our up-front payment as part of the technology license agreement, which was also executed together with the trademark license agreement. Last year, we announced receipt of patents for our technology and design for China and Hong Kong, and we recently announced a patent for our latest multi-joint EMG activated orthosis in Japan. This new patent will be valuable in establishing any future business ventures for the Japanese market. We entered 2022 with a backlog of a 154 units, representing over $5.8 million of potential revenue, of note, both our backlog and our candidate pipeline are larger than they were at the beginning of 2021. So we expect continued revenue growth this year, as we've seen good additions to the pipeline, we've addressed the short-term capacity insurance issues, and we have a growing number of payers that are reimbursing for the MyoPro. Medicare Advantage plans which cover 40 % of seniors in the United States are among our largest payers, and we continue to engage with staff and medical directors at the centers for Medicare and Medicaid Services, or CMS, to establish a pathway for Part B Medicare beneficiaries to gain access to the MyoPro for their paralyzed . In 2022, we intend to employ a dual-track strategy to try and speed access to the MyoPro for Medicare Part B patients. First, we expect to submit at benefit category change requests with CMS in the second half of the year to try and have our benefit category change from DME rental to a brace or orthosis. And in parallel, we intend to miss submit claims as a rental to the DME max before the end of Q2 and engage with their respective medical. directors on a case-by-case basis. Because it's free coverage process will likely involve appeals, we can't provide timetables for either decision on a better fit category change or for the ending to obtain coverage as a rental on a case-by-case basis. As it really depends on other priorities and projects at CMS, but we're going to continue to press our case for these patients. To support further reimbursement of the MyoPro product line, new independent research reports were published last month by researchers affiliated with the VA in Cleveland, who cited the MyoPro and treating stroke and traumatic brain injury patients, and by the Mayo Clinic for brachial plexus injuries. The clinical and functional outcomes they reported support the case for use of the MyoPro for individuals with chronic upper extremity paralysis. And there's more research underway in various other institutions as well. Now I'll turn the call over to Dave Henry to review our financial results in more detail, and I'll come back and provide some additional updates and comments on our plans for the rest of the year. Dave.

[Dave Henry:]

Thank you, Paul, turning now to our fourth-quarter financial results, revenue for the fourth quarter of 2021 was $4 million, which as Paul noted, was up 6 % over the prior year fourth quarter. A direct billing channel accounted for 73 % of revenue, which is down from 85 % of revenue in the third quarter of 2021 and down from 77 % of revenue in the fourth quarter of 2020. This is due to channel mix favoring VA and international revenue as we prioritized leverage that could become revenue given the supply chain constraints we dealt with in the quarter. Higher revenues in these channels resulted in a lower sequential ASP. We recognize revenue on 107 MyoPro units in the fourth quarter of 2021, up from 97 units in the fourth quarter of 2020. Out of the 107 revenue units, 26 were fill units, which means we received orders and authorizations in the same quarter that revenue is recognized. 46 % of fourth quarter revenue units converted from the beginning fourth-quarter backlog. As Paul mentioned, we successfully managed the reimbursement issue with a large payer. Though we've won appeals and collected payment on the vast majority of bill claims at September, the post-delivery denials are expected to continue for the foreseeable future. This means an extended aging of accounts receivable as the claims move through the appeals process. During the fourth quarter, patients insured by this payer represented 26 % of revenues compared to 32 % in the Third Quarter. Our backlog of units consists of insurance authorizations received, but not yet converted to revenue. As of December 31st, 2021, our backlog was 154 units, which was down slightly from 177 units as of September 30th, 2021. The year-end backlog reflects 104 authorizations and orders on the fourth quarter and 20 patients who exited the backlog without converting to revenue. The reimbursement pipeline as of December 31, was 808 MyoPro units, which reflects 221 additions to the pipeline during the quarter, and 229 dropouts, representing about 25 % of the pipeline entering the fourth quarter. By comparison, there were 331 additions to the pipeline in the third quarter. As Paul mentioned, the lower number of pipeline adds in the fourth quarter was driven by seasonal competition in social media advertising during the holiday season, which drove up advertising rates, and a decrease in percentage of leads that we're able to convert into successful evaluations. With respect to advertising during 2022, we intend to spend more in advertising in the first half of the year compared to the second half in the belief that our advertising dollars will be more effectively spent given past experience.

[Dave Henry:]

The drop percentage from the pipeline was higher than we typically see. By comparison, in the third quarter, 20 % of the patients in the pipeline dropped out. The increase in the drop percentage was driven by patient behaviors and an increasing number of decisions by the company to not go forward with patients during the appeals process as we prioritize our resources on appeals we believe we can win. Gross margin for the fourth quarter of 2021 was 77.4%. This is up from 73.4% in the year-ago quarter. The increase primarily reflects a larger number of revenue units versus deliveries. As you know, deliveries are when the company records cost of goods sold. There were 72 MyoPros delivered to patients in the fourth quarter on which we recorded cost of goods sold, compared with 107 revenue units. As we mentioned, deliveries were negatively impacted by the supply chain constraints we experienced early in the quarter, which has since been successfully addressed. Operating expenses for the fourth quarter of 2021 were $5.8 million. This is up 30 % compared with the same quarter a year ago, and primarily reflects higher research and development expense as we continue development of the MyoPro 2 + or completed development I should say of the MyoPro 2 + as well as higher advertising costs. Our operating loss for the fourth quarter of 2021 was $2.7 million compared with $1.7 million in the prior year's fourth quarter. Net loss available to common stockholders for the fourth quarter of 2021 was $3.4 million or $0.52 per share. This included a deemed dividend of approximately $600,000, which I'll discuss momentarily. As a comparison, net loss available to common stockholders for the fourth quarter of 2020 was $1.7 million or $0.37 per share. Adjusted EBITDA for the fourth quarter of 2021 was a negative $2.4 million compared with adjusted EBITDA in the year-ago fourth quarter, which was a negative $1.5 million. Turning to our full-year financial results, revenue for 2021 was a record $13.9 million, up 83 % over $7.6 million for 2020. The 2021 operating loss and net loss attributable to common stockholders were $10.3 million and $11 million respectively. And these compared with $10.5 million and $12.2 million respectively for 2020. Net loss attributable to common stockholders for both years included deemed dividends of approximately $600,000 and $700,000 respectively related to the re-pricing and discounting of certain warrants. Full-year 2021 adjusted EBITDA improved to a negative $9 million from a negative $9.8 million in 2020. Turning now to the balance sheet, cash, and cash equivalents as of December 31, 2021, were $15.5 million. Cash used by operations was $1.8 million in the fourth quarter. Accounts receivable were $2 million as of December 31, 2021, compared with $2.2 million at September 30, 2021, and about $900,000 at December 31st, 2020. The sequential decline was due to receipt of payments from the large insurance payer I mentioned previously. During the fourth quarter, we received net proceeds of approximately $4.8 million from an agreement with select warrant holders from our 2020 follow-on offering to exercise their warrants at a discounted exercise price of $5 per share. Discounting the warrants resulted in the deemed dividend I mentioned earlier. There were no shares sold under our ATM facility during the fourth quarter. With a cash position of $15.5 million at December 31st, 2021, we believe our existing cash is sufficient to fund operations for at least the next 12 months. Finally, turning to our near-term expectations, we entered 2022 with a higher year-over-year backlog and are pleased that our fourth-quarter supply chain challenges were resolved, and we've been able to manage through the post-delivery denials by the large insurance payer. As a result, our revenue recognition practice with this payer remains unchanged. With that backdrop, we expect revenue for the first quarter of 2022 to be in a range of $2.6 million to $3 million, which would be an increase of 11 % to 28 % over the first quarter of 2021 with continued year-over-year revenue growth expected for the full year 2022. With that overview, I'll turn the call back to Paul.

[Paul Gudonis:]

Thanks, Dave. Well, our strategic goal is to assist more paralyzed individuals regain function with the MyoPro and to increase our market penetration in this new product category, the strategic pivots we undertook several years ago to do direct to patient marketing and direct billing are really paying off with strong revenue growth, a higher ASP, and expanded margins. A key aspect of improving our operating efficiency is the digital transformation we've undertaken. We've been a leading adopter in the industry of telehealth for patient evaluations, therapies training, and online support. And with the new MyoPro two plus, we've added lower-cost 3D printing and the ability for our clinicians to use remote measurement technology. Our clinicians can now measure a patient's arm and hand remotely and immediately transmit the specs to our 3D component vendor. We expect this approach will enable us to offset the general inflation that we're all experiencing and maintain our margins while reducing our staff travel costs and increasing productivity of our team.

[Operator:]

Question and answer session. . At this time, we will pause momentarily to assemble our roster.

[Paul Gudonis:]

Before we take the first question, I want to mention that we are available for virtual and in-person investor meetings. So please contact LHA Investor Relations to set up a time. We plan to be in person at the Roth Conference in Dana Point, California next week. And we will be participating in the virtual Oppenheimer and Company Conference later in the week. Please contact LHA if you plan to be there and would like to meet with us in person. Their contact information is on today's news release. Okay Operator, we're ready for the first question.

[Operator:]

Our first question comes from Scott Henry with Roth Capital, please go ahead.

[Scott Henry:]

Thank you. And good afternoon. A lot to go through, but let me just pick a couple of things. I guess first with the reimbursement pipeline ads sort of the top of the funnel. It sounds like you said the first two months of the -- of '20 or first-quarter, you've got about 200, which would imply around 300 for the quarter. Last year, it was about 386. The question is, do you think you can continue to grow reimbursement pipeline ads? Do you expect to have a greater number of pipeline adds in 2022 than 2021? Thank you.

[Paul Gudonis:]

Yes, Scott. Absolutely, we do. We're off to a good start already in Q1, as Dave mentioned, what we see is seasonality in social media advertising costs. We compete in the holiday season with lots of other advertisers looking at -- for that same audience. So we've shifted more advertising dollars in the first part of the year, but I've seen so far, and our plan is to continue to grow that pipeline strongly so we can continue the revenue growth we've seen.

[Dave Henry:]

And we're also seeing that seasonality. We're anticipating that with the -- an election coming up in the fall of 2022, that there will be even more increased competition for social media advertising in the fourth quarter and even third quarter as well. That's why we're shifting a lot of our advertising spending to try to prioritize it in the first half of the year to stay away from that competition in the second half of the year. And also we're going to be testing other forms of media, things like television, for example, to see if we can't bolster lead generation even further and also bring down that cost per pipeline ad.

[Scott Henry:]

Okay. And then obviously there's a lot of variability from quarter-to-quarter. But this quarter, it seems like you've got a higher number of patients dropping out of the pipeline, higher number dropping out of the backlog, would you say that that's variability or perhaps could you be getting a little more conservative given that you had the reimbursement issues, perhaps being a little more selective in your patients to try to avoid that or do you think it's just noise?

[Dave Henry:]

I'll speak to the backlog. I think the backlog drop rate was just a little over 10 % which was -- it's in the ballpark of where it's been. I think the pipeline drops were higher and Paul went through. There's a number of reasons we think why; we can't pinpoint one reason exactly. We think it's a number of different factors. But it's something that we're -- some of it we can control, some of it we can't like patient behaviors. And so we just have to try to do the best we can with the leads that we generate and focus on improving yield throughout the process, throughout the patient's journey.

[Scott Henry:]

Okay. And the shift, I mean, it seems like it was such a strong shift towards direct billing and now it kind of went the other way in this quarter. Same question, is that a trend or is that noise?

[Dave Henry:]

I think that's a little bit noise as well because as we mentioned earlier, because of the supply chain constraints, we reprioritized deliveries where we could take revenue, and so direct billing for much of the direct billing revenue, we couldn't take revenue in the fourth quarter if we delivered in the fourth quarter. So that's a reason why you saw the direct billing percent come down, and I would expect, as the supply chain noise cleans out here fully in the first quarter, that percentage should start to creep back up again.

[Paul Gudonis:]

Although Scott, I'll add that there are other couple of good things going on there, is with all the new research published by the VA, we've expanded a number of VA medical centers now from 40 to 60, that have purchased at least one MyoPro for their veterans in their care. And as I mentioned in my remarks, we're really doing some strong growth, especially in Germany. So that is adding revenue growth as well to the company.

[Scott Henry:]

Okay, great. And this re-pricing of warrants, if that a legacy issue, is that contractually obligated or why is that happening?

[Dave Henry:]

We just did that -- in October we did that to incentivize the exercise of some of the warrants that were in the money that were issued in the 2020 offering that we did. And so that brought some cash into the company and took some warrants off the rolls, which were -- we believe to be an overhang on the stock. So we felt it was a good thing to go ahead and do, but from an accounting standpoint, the discount of the warrants is treated as a deemed dividend.

[Scott Henry:]

Okay. That's helpful. That's good clarification. Thank you for taking the questions.

[Operator:]

Our next question comes from Benjamin Haynor with Alliance Global Partners. Please go ahead.

[Benjamin Haynor:]

Good afternoon, gentlemen. Thanks for taking the questions. As they previously mentioned, a lot of ground has been covered, but just hitting on the pipeline drops in one more fashion. You mentioned behaviors by patients, what would go into that bucket and are there things in there that we haven't seen historically?

[Dave Henry:]

I think a lot of it might be just -- I would throw things like COVID into that. Omnicron was pretty prevalent in the fourth quarter. If the patient is not willing to go see their doctor in order for us to be able to obtain their written order and a letter of medical necessity, we can't move forward. And so there's a lot of that that happens and you'd be surprised how much of it happens actually. So it's something that we with the insurance provider and trying to keep the patient connected and engaged throughout the process which can last several months. And so we are constantly trying to improve that to bring that down. It's not something that we're just sitting by and looking at and wondering why. We're actually trying to do things to try to correct it.

[Benjamin Haynor:]

Okay.

[Dave Henry:]

But as I said, it's -- we can only control what we can control. Right.

[Benjamin Haynor:]

Yeah. Understandable. So then just turning to the Q1 guidance the $2.6 million to $3.0 million. I believe there's a $2.7 million that you guys are -- will be getting during the quarter from Ryzur. Does that show up as other income? And then kind of any other color you can provide on the China

[Dave Henry:]

If the payment comes in, it would be recorded as revenue. The guidance that we gave was for product revenue. And we've been told that we will be paid by March 31st, I don't have the cash in hand yet. We'll report it when we get it.

[Benjamin Haynor:]

Okay. So stay tuned and now that would be something that you would put out a press release or at least plan to?

[Dave Henry:]

We'll communicate it somewhere.

[Benjamin Haynor:]

Okay. That's helpful. And then, I just wanted to kind of get any color you can provide on the early reception to the MyoPro 2 +, not only from I guess the patient standpoint, but also the logistical improvements that that should enable.

[Paul Gudonis:]

While we're ramping up our production of that. So production now ramped up in February, more orders are coming in. We're doing the fittings of patients. We do have the new remote measurement kit, but I think we explained initially that we are doing in person usage of that remote measurement kit, so that our field commissions get that hands-on experience, we get that measurement right. And then we will start to migrate where we'll just be able to ship out the briefcase to the patients and our clinicians will be on a Zoom call, walking them through the process. They'll take a picture of the arm, they'll scan the hand, and then that comes right back into our model for the 3D printing production. So that'll save the whole -- one more visit. We used to do three visits with a patient via in-person evaluation, then the casting of their arm and then the fitting. So as we migrate to our greater percentage of our orders being remotely measured, we'll have eliminated two out of those three visits. So that means our staff can be more productive, shorter cycle time and lower costs.

[Benjamin Haynor:]

And do you think that helps ultimately converting them to revenue units? The shorter cycle time that is.

[Paul Gudonis:]

Yes, that's the time from when we actually get the insurance authorization. If I can just ship out a part of that cycle time reduction, and also I don't have to then ship a cast to GRE, our fabricator in Ohio, that takes a couple of days at least to fabricate it, to ship it back to us here in Boston for final inspection. We're basically are going to be compressing that cycle time.

[Benjamin Haynor:]

Got it. And actually just one more follow-up on Ryzur. Do you have any idea how long the tech transfer might take once that gets underway?

[Dave Henry:]

It's going to be a -- it'll be an ongoing process really. I think initially what they'll do is we'll start with devices that they can supply to rehab hospitals and other facilities where they can start to build the pipeline of patients they can actually deliver the device to once they have the equivalent of their -- of FDA approval to begin manufacturing. So that's their initial process. And so we'll be first teaching them how to build these units then we'll go into the hospitals, and then we'll go forward with actually then the 2 + after that.

[Benjamin Haynor:]

Okay. Got it. Thanks for taking the questions, gentlemen. That's it for me.

[Paul Gudonis:]

All right. Thank you.

[Operator:]

Next question comes from Jim Sidoti with Sidoti and Company, please go ahead.

[Jim Sidoti:]

Hi. Good afternoon and thanks for taking the question. With the direct billing patients, when do you recognize revenue?

[Dave Henry:]

For most of the up -- for most insurers and I'll say it's about 60 % of the direct billing revenue we recorded a payment. For the rest of that. And primarily that large insurance payer that we've been talking about, where we have -- there -- that's the only revenue in the direct billing channel that will recognize a delivery.

[Jim Sidoti:]

Okay. And in the quarter --

[Dave Henry:]

Everything else is that payments. Everything else was a payment.

[Jim Sidoti:]

And in the quarter you made the decision to ship more to the VA customers because those shipments you recognize -- you recognize those orders at shipment, as well. Is that correct?

[Paul Gudonis:]

That delivery as well is in our -- in Germany as well. Germany was more than 10 % of revenue in the fourth quarter.

[Jim Sidoti:]

But so you able to grow the gross margin despite that shift towards the lower paying VA units. went up?

[Dave Henry:]

Well, there was a disparity between the number of revenue units so you're just able to take revenue on which is 107, and the number of deliveries was 72. So we had -- in essence we had 35 units where we took cost of goods sold in the prior quarters, but we took revenue this quarter.

[Jim Sidoti:]

Okay. So those 35 units were direct billing payments to insurers that you don't ask that the SG&A expense it ticked up to about $5 million in the quarter, and I assume that's as a result of the increase in advertising costs. Is that kind of the new number going forward? Around $5 million --

[Dave Henry:]

I mean, if it's going to be, I would say that, yes. I mean, advertising costs in the fourth quarter were $1.1 million and they were $3.5 million for the full year. So by comparison for the full year last year, they were $800,000. So you can see what companies like Facebook and Google, if you're wondering where their earnings are coming from, then you look at that number.

[Jim Sidoti:]

I think this is one of the first quarters that I guess you did last quarter too, when you had the supply chain issue, is this going to be the new trend to provide quarterly guidance for one quarter forward?

[Dave Henry:]

We gave guidance this quarter because we're so far into the quarter, and we have a fairly good idea of where things are going to end up. And so it's a decision between, do you say nothing and have people wonder why you're saying nothing when you're so far in the quarter, or just give a range. And so we landed on giving a range.

[Jim Sidoti:]

Okay. Alright. Thank you.

[Operator:]

Our next question comes from Edward Woo with Ascendiant Capital, please go ahead.

[Edward Woo:]

Thank you for taking my question. My question is on your international business, is it as strong as your domestic business?

[Dave Henry:]

I think in terms -- I mean, while an overall revenue dollar is still -- the U.S. is still little, almost 90 % of revenue, but international is growing. We were -- it was more than a little bit more than 10 % of revenue for the full year. We're adding headcount there. The pipeline is growing there and we're looking for more growth over there in 2022. We're also seeing other locations, Italy, Australia, where we've got units going out to those places as well. So we're optimistic about the international market and certainly look to grow it. Because we do get, from the standpoint of the hierarchy of ASP, they are -- that's overall the best ASP channel except for the U.S. direct billing channel.

[Edward Woo:]

Will you guys maybe spend more resources there?

[Dave Henry:]

Yes. Yes. And as I mentioned, we've added heads and we expect to add more headcount there in 2022.

[Edward Woo:]

Great. Well, thank you for answering my questions and good luck. Thank you.

[Dave Henry:]

Thanks Ed.

[Operator:]

Our next question comes from Kyle Bauser with Colliers. Please go ahead.

[Kyle Bauser:]

Great. Thanks. Good evening. And thanks for all the updates. Maybe I'll start on the large insurance payer that had begun to deny preauthorized claims. Paul, I didn't quite catch it. It sounds like you've been able to appeal those and then get paid, except for maybe four claims. Could you just walk through that and do you plan on appealing those again, just curious?

[Paul Gudonis:]

So there's been more than 50 since September, since this all started. There -- we filed more than 50 claims with this insurer. Of those 50 claims, the vast majority of them have been paid. There's some that haven't been paid yet, for claims that were filed in January, February, they might be still open and they haven't been denied yet. But then except for those four that -- where the appeals were denied, everything else has been paid either in whole or in part and for people that -- for claims that have been paid in part, we're working on getting the rest. So from that standpoint, the whole -- the process is, right now, just an exercise and having to go take an extra step in order to get paid. For the four that haven't been paid, we expect that -- we've looked at the reasons that the denials are happening and we don't think they are valid. And that's why we think that those will ultimately be overturned. And so it's a process that we're going to continue to monitor. It's unfortunate that we have to go through this but the insurer told us that this was -- they told us it was a temporary situation and we've worked well with them in the past and hopefully that this -- hopefully this situation will end up resolving itself and we'll just go back to doing business as normal. But in the meantime, they are putting us -- they're making us jump through these hoops but they continue to pre -authorize new patients. So right now, it's just -- as I said, it's an extension of our aging right now.

[Kyle Bauser:]

Got it. That makes sense. I think -- is it four times you can appeal it or five? What's the process?

[Paul Gudonis:]

This post-delivery appeal process is new to us. So I'm not sure of the exact number, but generally in the -- when you're trying to appeal an authorization, you appeal two times and then you go to an ALJ hearing. Around these outpost denial payments, it's been one appeal. And again, in the vast over 90 % of the cases, it's been paid after that first appeal.

[Kyle Bauser:]

Got it. And is this in your assessment just a glitch or is it more broad across other devices?

[Paul Gudonis:]

No, they -- this insurer told us -- we were speculating a few months ago that maybe there was just a change in the system that was done by somebody that was kicking out the -- our claims in a systemic way. But what we've come to understand is that the insurer is actually -- what they did, it wasn't done by mistake, it was done consciously, and they're just making sure that our claims are thoroughly reviewed before they're paid because it is still their policy that our device is experimental and investigational.

[Kyle Bauser:]

Got it. But I mean, the success rate has been basically 100 %. So, good. Okay, got it.

[Paul Gudonis:]

That's right. And I've got to mention to you preauthorize. And we've got written testimony from ALJ areas that they don't consider experimental investigation anymore. And we've already had over -- close to what, 1500 plus devices reimbursed by various payers in the field.

[Kyle Bauser:]

No, for sure, it makes sense. And then just switching, I'd say you move fabrication in-house. So what are kind of the margin improvement implications for that? And maybe more broadly, what else do you anticipate in the future maybe bringing in-house, or are you kind of good to go for a while?

[Paul Gudonis:]

With respect to the 2 +, I think what will -- for the first half of the year, I mean we have seen some price increases, everything from laptop computers to transportation costs, etc. And so whatever cost reductions that are embedded in material cost of the 2 + for the the first half of the year are being offset by those price increases that we've already seen. So we're back to sort of status quo. Any cost improvement we expect will occur starting in the second half of the year, after our clinicians get fully comfortable with the remote measurement devices, and then begin to actually using them on a remote basis and not traveling to see a patient. And once that happens, we think that we can say if it up $1,000 per unit. Once that travel is eliminated.

[Kyle Bauser:]

Got it. That's helpful. I appreciate that. Well, great updates. I appreciate you taking my questions.

[Paul Gudonis:]

Sure. Thank you.

[Operator:]

We have time for one more question. That question comes from Paul Nouri with Noble Equity, please go ahead.

[Paul Nouri:]

How much of the accounts receivable balance is from this insurer that you're going back and forth with?

[Paul Gudonis:]

It's around. I'm going to guess the number off the top of my head. It's somewhere in the neighborhood of between 30 % and 40 %,

[Paul Nouri:]

Okay. And on average, how long is it taking to collect from this insurer?

[Paul Gudonis:]

Right now? From the time that we submit a claim, it's taking at least two to three months.

[Paul Nouri:]

Okay. Alright. Thank you.

[Operator:]

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

[Paul Gudonis:]

Well, thank you, Operator. Well in closing, it appears that the worst of the pandemic is now behind us. And we hope that the military conflict between Russia and Ukraine can be resolved as we do not -- are not directly impacted by this conflict since we don't have any customers or suppliers from either country. We do provide an essential product to people suffering from neurological disorders and upper-limb paralysis and we'll continue to focus on reaching more patients, receiving more buy-in from payers and ultimately from Medicare Part B and additional state Medicaid plans as well. Once again, thanks for your time and your interest in Myomo's. Have a good evening.

[Operator:]

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.