Myomo Inc (MYO) 2021 Q1 法說會逐字稿

Hello, and welcome to the Myomo, Inc. First Quarter 2021 Earnings Conference Call. (Operator Instructions) Please note today's event is being recorded. I would now like to turn the call over to Kim Golodetz. Ms. Golodetz, please go ahead.

Thank you, operator, and good afternoon, everyone. This is Kim Golodetz with LHA. Welcome to the Myomo First Quarter 2021 Financial Results Conference Call. Earlier today, Myomo issued a news release announcing financial results for the 3 months ended March 31, 2021. 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 in New York at (212) 838-3777 and (technical difficulty).

Ms. Golodetz accidentally dropped off the line.

I'll just continue going on from where she left off. 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 word 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 are discussed in the risk factors and other qualifications contained in Myomo's filings with the Securities and Exchange Commission, including the Form 10-Q for the quarter ended March 31, 2021, which was filed earlier this afternoon.

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's now my pleasure to turn over the call to Paul Gudonis, CEO of Myomo. Paul, please go ahead.

Well, thank you, Dave, and good afternoon, everyone, and thanks for joining us today. After I provide a business update, Dave will review our first-quarter 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.

With about half of the U.S. population now having received at least one injection of the COVID-19 vaccine, we're encouraged that our business is well on its way to operating in a more normal pre-pandemic environment, while our clinicians continue to take precautions to protect themselves and their patients.

As I've discussed on past calls, during 2020, we adjusted our operations, in particular, regarding our use of telehealth and online marketing. This adoption of digital technologies supported the continued growth of Myomo last year and to date in 2021.

We continue to utilize telehealth and online marketing as these modes of reaching patients are not only mainstream now, but they're also cost-effective and very efficient. Last fall, we engaged a new marketing firm with a particular expertise in digital advertising, and we've already seen a very positive impact from their work.

I'm pleased to report that our revenue growth has been accelerating, rising from 50% to 60% just a few years ago to doubling last year and further accelerating to year-over-year growth of 132% during Q1 of 2021. Our first quarter revenues were $2.3 million on 65 revenue units, which was up 117% from the year ago revenue units.

With the strategic shift to our own direct billing channel, where we bill patients' insurers directly and provision the MyoPro with our own clinical staff, we continue to report year-over-year increases in average selling price. During the first quarter, revenue from the direct billing channel was 73% of revenue compared with 62% a year ago.

Our gross margin has also improved with the emphasis on the direct billing approach compared with other channels, as Dave Henry will describe in a moment. With approximately 3/4 of revenue coming from the direct billing channel for the past 2 quarters, it appears that the shift is largely complete.

Note also that we established a reimbursement track record with additional insurers. We expect to be able to recognize revenues faster, thus shortening the cycle time from lead to revenue.

Our backlog, which is defined as MyoPros that have been authorized by payers but are either in the process of being delivered to users or are awaiting payment to us, was 118 units at quarter end. As we expected, this was down sequentially from 131 units at year-end 2020 as authorizations and orders were lower sequentially in the first quarter.

We received authorizations and orders for 66 patients to receive a MyoPro during the first quarter. However, we expect the number of patients approved for MyoPro to increase sequentially as we already had 35 authorizations and orders in April, the first month of Q2.

We had the strongest growth ever in our patient pipeline in Q1. After adding about 200 candidates per quarter in the last 9 months of 2020, we added 386 medically qualified candidates into the pipeline in the first quarter. This is a result of increased ad spending, less competition from political ads on social media platforms after the November elections, and potentially a positive shift in consumer sentiments as the pandemic abates and people are more confident about their health and financial situation.

As of March 31, 2021, our pipeline was up 22% sequentially and stands at 940 MyoPro units in the reimbursement process. We're spending more in advertising in order to reach prospective candidates and to grow our pipeline. And part of this increase in advertising spend was directed toward advertising in new media outlets.

For example, a full-page ad for the MyoPro appeared in the March issue of AARP Magazine. We expect to advertise in other outlets beyond digital media in the coming quarters. The increased marketing spending is an important part of our growth strategy and it's showing clear results. As a reminder, it will take several months for these candidates to work their way through the insurance process, through an authorization, then eventual delivery and payment.

Also, we expect between 10% and 20% of the pipeline to fall out each quarter due to personal patient issues and/or a lack of insurance approval, so we take this into account in our planning. Since we had HCPCS codes for the MyoPro issued in 2019, we've seen an increase in patient access to our devices with more payers covering the MyoPro on a case-by-case basis for their beneficiaries. In particular, we've experienced strong growth among Medicare Advantage plans covering the MyoPro.

It's important to note that we continue to sell our products on a wholesale basis to O&P providers for resale to their patients. And these O&P providers, veterans' administration, hospitals and international sales accounted for the remaining 27% of Q1 revenues.

We're also [reasonably] encouraged by President Biden's speech, in which he noted that approximately 800,000 new enrollments into insurance under the Affordable Care Act have occurred recently. Obviously, the more patients with insurance, the more potential users of a MyoPro device.

Regarding our international business, we expect it to grow at a meaningful pace this year. During Q1, we announced additional statutory health insurers have approved reimbursement of the MyoPro on a case-by-case basis in Germany, and these insurers now provide the foundation for reimbursement of approximately 40% of that country's population. As other markets reopen from COVID, we've now got patient screening days scheduled in the U.K. and Australia.

We're also adding to our head count in Europe this year and have launched a German Myomo website and begun online advertising there as well to replicate our marketing success in building the patient pipeline in the U.S. that we've seen.

During the first quarter, we also announced an important joint venture and technology licensing agreement with Ryzur Medical, a provider of medical devices and rehab hospital services in China. We chose Ryzur after several years of discussions with a number of potential partners for the largest market in terms of population with upper extremity paralysis.

The formal launch of the joint venture is expected by the end of this year. We first need to secure all the necessary government approvals from both the U.S. and China. And once the JV company is established and other milestones are completed, our Chinese partners will provide initial capital to the JV company to fund its operations to locally manufacture and distribute the MyoPro.

Myomo will receive a 19.9% equity interest in this venture. We'll also receive an upfront license fee and annual license payments over the next 10 years after the venture is established. To reiterate, the launch of this joint venture is ongoing and will take some time for -- over the course of this year to materialize.

Now I'll turn the call over to our CFO, Dave Henry, to review our financial results in more detail. Then I'll come back and provide some additional updates and comments on our plans for the rest of the year. Dave?

Thank you, Paul. Turning to our Q1 financial results. Revenue for the first quarter of 2021 was $2.3 million, which was up 132% over the prior year first quarter. A higher average selling price, along with a higher number of MyoPro revenue units, drove this increase and reflects success with our direct billing channel and our marketing efforts. More specifically, we recognized revenue on 65 MyoPro units in Q1 of 2021, an increase of 117% compared with the first quarter of 2020.

Our backlog of units consist of insurance authorization received but not yet converted to revenue, and our backlog as of March 31, 2021, was 118 units. Ending backlog reflects 66 authorizations and orders in the first quarter and 14 patients that exited the backlog without becoming revenue. Approximately 92% of the backlog is comprised of direct billing candidates.

Gross margin for first quarter was 73%, up from 68% in the first quarter of 2020 and flat sequentially. The year-over-year increase primarily reflects a higher average selling price, again reflecting the shift to our direct billing channel.

There were 50 MyoPro delivered to patients in the first quarter for which we recorded cost of goods sold. With 65 revenue units, that means a net 15 revenue units were recorded at 100% margin because cost of goods sold was recorded in a prior period when the units were delivered. This favorably impacted Q1 gross margin as well.

Operating expenses for the first quarter of 2021 were $4.6 million. This is up 13% compared with the same quarter a year ago and primarily reflects higher compensation and advertising costs. The operating loss for the first quarter of 2021 narrowed to $2.9 million from $3.4 million a year ago.

The net loss attributable to common stockholders for the first quarter of 2021 was $3 million or $0.57 per share, and this compares with a net loss attributable to common stockholders of $4.5 million or $2.51 per share for the same period of 2020. Net loss attributable to common stockholders in the first quarter of 2020 includes a deemed dividend on the repricing of warrants of about $700,000.

Adjusted EBITDA for the first quarter of 2021 was a negative $2.7 million, and this compares with a negative $3.3 million for the first quarter of 2020. Cash and cash equivalents as of March 31, 2021, were $17.4 million, which includes $7.3 million received from the exercise of approximately 1 million warrants during the quarter. Roughly 1.7 million warrants remain outstanding.

Cash used by operations was $2.1 million in the first quarter and includes a deposit of about $500,000 we paid to one of our contract manufacturing partners to enable the procurement of inventory to support projected 2021 demand for MyoPro devices.

Our cash utilization is also benefiting from lower rent as we took advantage of the favorable commercial real estate market to relocate our offices from Boston -- to Boston from Cambridge. This move not only reduces facility rent costs but will also better accommodate our projected growth.

Turning to our guidance. Cash used by operations is expected to increase in the second quarter of 2021 compared to the first quarter due to our annual incentive compensation payments. We believe that our existing cash is sufficient to fund operations well into 2022.

We expect that cash flow throughout 2021 will follow a similar pattern to 2020, with higher cash used by operations in the first half of the year and lower cash utilization in the second half, with the goal to reduce cash used by operations for the full year 2021 compared with 2020. With lower cash used in operations in the first quarter compared to the prior year, we are on track to achieve this objective.

As Paul mentioned, during the fourth quarter of 2020, we engaged a new digital advertising agency, and the record number of pipeline additions in the first quarter reflect the beginning of the positive impact of that change, as well as other marketing changes and a more favorable digital advertising environment with the political season behind us.

We expect that these pipeline additions will result in a growing number of insurance authorizations in the second quarter, with 35 authorizations and orders during the month of April supporting that expectation.

We also expect the number of pipeline additions during the second quarter of 2021 to be approximately equal to the number of additions during the first quarter. Year-over-year revenue growth in the second quarter is expected to be in line with first quarter's year-over-year growth rate.

Lastly, so long as we continue the gradual reopening that is underway and travel restrictions and public health lockdowns continue to be in the rearview mirror, we expect we are well positioned for a strong 2021. With that overview, I'll turn the call back to Paul.

Thanks, Dave. Increased authorizations by health insurance companies are an important component of our growth strategy. Our Chief Medical Officer, Dr. Harry Kovelman, is very focused on obtaining what we believe are appropriate coverage policies for the MyoPro so that more patients have access to our devices.

Back in January of 2019, the Centers for Medicare and Medicaid Services, CMS, established 2 new billing codes for the MyoPro, which resulted in certain Medicare Advantage plans paying for the device on a case-by-case basis. And while results of these new billing codes [in] Medicare Advantage plans are now providing support for much of our current business, we still have work to do to obtain more appropriate and wider reimbursement.

We previously discussed that these Medicare Advantage plans cover about 35% of seniors, while the larger portion of Medicare beneficiaries are covered under Part B, where the MyoPro is coded as durable medical equipment rental.

Because the MyoPro is custom fabricated for each patient and is designed for long-term use, we continue to seek a correction in the benefit category and recently applied for such a change with the submission of a code amendment for consideration this year. However, there's no guarantee that CMS will issue a coverage policy or an acceptable payment amount for the MyoPro, in which case we'll continue to address the large population of paralyzed individuals covered by other payers.

As you may recall, early in 2020, we began testing our new MyoPal device, which is designed for the pediatric market. Because of the pandemic, we put that work on hold. As vaccinations become more widespread and parents are more comfortable with clinicians meeting with their children, we plan to restart the testing and final design work on this product later this year.

We have clinical research underway at several medical facilities and are looking forward to the first of these studies to be published later this year. In the meantime, we're working with other institutions who are proposing breakthroughs, such as using brain implanted electrodes to control a MyoPro if the patient has insufficient EMG signal strength in the arms. Earlier this year, CBS Sunday Morning highlighted such a patient at Thomas Jefferson University Hospital in Philadelphia.

We believe that a macro investment thesis is emerging around technologies that facilitate a brain-to-computer interface. With our EMG sensor technology, Myomo is a leader in this space today and is well positioned to benefit in the future as new technologies are introduced.

Returning to the present, we're focusing on increasing our penetration of the large population of those with chronic paralysis, offering the only solution that works for them after they've tried conventional treatments such as occupational therapy. There's a deep pool of patients that could benefit from a MyoPro, and this addressable market grows each year with 800,000 strokes occurring annually just in the United States, leaving several hundred thousand of these individuals with arm and hand paralysis.

We're pleased with our efforts to access more of these candidates in the first quarter, and we look to continue this success in the coming quarters. This concludes the formal part of our presentation, operator, and we're ready to open the call to questions.

(Operator Instructions)

And before we take the first question, I want to mention that we're available for virtual investor meetings during this time of limited travel. So please contact LHA Investor Relations to set up a time. Their contact information is on today's news release. We'll also be participating in some upcoming virtual conferences during the second quarter, including the Oppenheimer MedTech Tools and Diagnostics Summit later this month and Sidoti's Virtual Small Cap Conference in June.

All right. Operator, we're ready for the first question, if you are.

Yes. And the first question comes from Scott Henry with ROTH Capital.

Just a couple of questions. First, when I'm just looking at the metrics, it looks like authorizations dipped in Q1 from prior rates. I know it snapped back again in 2Q based on April. But can you talk about what factored into why it went down in Q1? And is that just kind of a onetime event? Or how should we think about that?

Well, it was equivalent to where we were a year ago, Scott. I'd say part of it is there was a big push for authorizations in Q4. As you know, we had a strong Q3, Q4. We've always seen seasonality in this business. It might be that with the holidays back in December, processing these appeals or authorizations may lag.

And we don't -- and sometimes, we don't hear from the insurance companies for 30 to 60 days after an appeal, for example. And that's why perhaps, we're seeing more -- we had a strong March and another strong April. So that may be the reason for that.

Okay. Okay, great. And then I guess, similarly, the percent of the cumulative pipeline that kind of just goes away, that was a little higher in Q1 than historically. Just noise there? Or would you expect to kind of normalize towards that 15%, which is the midpoint of the 10% to 20%?

It was probably high -- the historical range is sort of typically 10% to 20%, it might have been in the high end of that range. I don't think there was anything unusual about the drops that -- from the pipeline that occurred in the first quarter.

Okay. Fair enough. And then on gross margins, obviously, they're helped a little bit in this quarter. But what would you view as a sustainable gross margin percentage going forward?

I would say, on a steady-state basis, gross margin in the range of 70% to 75%.

Okay. 70%, 75%, that's great. And then as well, obviously, you're adding patients much better at higher rates than in the past. I mean should we think about that as kind of the new normal now? This 300, and call it, 350 to 400 range, is that achievable on a consistent basis?

Well, I mean, there's a lot of factors that go into that. But we -- for the things that we can control, which is the advertising money that we spend and the way that we run our operations, we are doing what we can to increase the activity levels throughout the organization. And it starts with lead generation that we spend advertising money on and it filters its way down. So if we're to achieve the objectives we're trying to achieve, we need to continue to do what we've been doing.

Yes. It's a good leading indicator because -- of future revenues because those patients will work through their pipeline to revenue over the next 6 to 12 months.

And the next question comes from Kyle Bauser with Colliers Securities.

This is Kayla Hostetler on for Kyle. I guess, first, the direct billing pipeline continues to build and drive nice margins. What do you think is like a reasonable goal for the direct billing channel? Would it be 100% of new business?

I don't think it's going to be -- it will never be 100%. We're always going to have an international business. We will always have -- hopefully have VA revenues, and we want to maintain the O&P channel as well. So I think as it gets -- I'm hopeful that we -- that the direct billing channel doesn't get above 80% because that means that the other channels are growing, which is what we want to see happen.

Right. Okay. And then can you talk about how head count has changed over the past 12 months? What's the latest number? And then as you think of adding new employees, which part of the business do you anticipate adding to the most?

Yes. Overall head count right now is around, I would say, in the mid-70s, 75 people, I believe. And most of the head count adds -- I would say that the head count adds have been -- we expect them to be stronger in the first half of the year and then taper off in the second half of the year, as we've been doing a lot of work to put the capacity we need to have in place to service the greater number of leads coming in and the evaluations we have to conduct and all the way through our patient pipeline. So we're setting ourselves up now, and I would expect the adds to the head count to decelerate as we move through the rest of the year.

Yes. Where we've added folks are in the field clinical staff because there are more people, almost double the amount of candidates now to evaluate coming into through the advertising. So we have field clinical staff that does these evaluations, and then they'll do the ultimate fittings for these patients in the direct billing channel.

We've grown our reimbursement support team under Dr. Kovelman. And then we've also added a few quality inspectors and engineers to support the growing volume because we have to make sure every device is inspected before it's delivered to a patient.

Great. And then last question. As far as average selling prices of MyoPro, how should we model this going forward? Still around $35,000?

Yes, I would -- from a modeling standpoint, I would use $35,000 as a number to model off of.

And the next question comes from Jim Sidoti with Sidoti & Company.

Just following up on average selling price, it looks like it was about $35,600 in the quarter based on 65 units shipped. What was it in the May -- in the March '20 quarter a year ago?

It was a little under $34,000.

Okay. All right. And seems like accounts receivable dropped substantially in the quarter. I know orders were down a little from the last quarter. But does that indicate at all your ability to get paid from the third-party payers? Is that becoming easier now that you're direct billing?

Well, actually, under -- with direct billing, we don't -- except for those certain insurers that were taking revenue on delivery, we actually wait until payment to recognize revenues. So the receivables that we have are from the O&P and the VA providers and international channels and then that portion of our direct billing revenue that we're able to take on delivery.

And the reason we're able to take the direct billing revenue now on delivery is that we've established sufficient collection history. So I think that -- just circling back to the decrease in receivables, I think that's just a function of the decrease sequentially of the revenue, which is expected, by the way, just because of our -- the way the -- traditionally the business has been operating.

Okay. And then last one for me. You raised about $7 million in the quarter from the sale of warrants. Is that something that you can predict going forward? Or is that going to be more based on the share price? And what is a good share count for 2021?

Yes. We didn't we didn't sell any warrants, just to be clear, they were exercised. So --.

Right.

And so the it's hard to say what might -- what stock price might trigger more exercises. So it's hard for me to speculate on that. And in terms of our share count, our share count as of May 1 was 5.6 million shares.

We're not anticipating -- we say that we have sufficient cash to go well into 2022. So we're not expecting any financing activities that we initiate. So it's -- any increases in shares will primarily come from if there do happen to be additional warrant exercises.

And the next question comes from Edward Woo with Ascendiant Capital.

Congratulations on the quarter. My question is, you mentioned that it takes about 6 to 12 months from when a patient is identified, get into the pipeline and eventually recognized as revenue. Have you seen that speed up at all?

I think -- we're starting, I think, to see that. And I think we'll see that more as we continue through 2021 and as the rate and the numbers of patients cycling through all the way to revenue begin to increase. I think we'll see that more as we go forward.

But until that time, I mean, it is dependent on the number of authorizations that we get from that insurance company, and that can fluctuate on a month-to-month basis. So it's -- I think the better way to look at it will be probably quarters at a time and not months at a time.

Great. And then do you guys notice any issues with your supply chain, either significantly higher costs or shortages on certain parts coming from Asia?

We are seeing some cost increases, like, for example, laptops and things like that.

Steel bars used in the MyoPro, we're seeing that.

Yes. So we are seeing some cost increases. But we are working on cost decreases as we do some of our engineering projects. But from -- in terms -- from a supply standpoint, while there are some -- obviously, that we've heard about and been aware of the shortages of certain electronic components. But right now, we're able to procure what we need. So in terms of straight supply, we're doing okay right now.

And the next question comes from Paul Nouri with Noble Equity.

Could you describe in some detail about how much the advertising environment has improved for you guys? And if it is mostly from the presidential election? Or if there was also an effect from people getting out and shopping more in-person as opposed to online? And maybe the cadence of the improvement over the past 5 months or however long it's been.

Well, as you may be aware, the way these platforms like Facebook work is you're in a constant auction for eyeballs. And in the fall, we were competing with a certain budget that we had set with a lot of other advertise -- specifically political advertising. So that calmed down after November, and then we increased our spending.

While we don't break out the advertising dollars in total, it's just under $100 a lead. And if that turns out to be a good payer, a medically qualified candidate, that could lead to a $35,000 sale. So we see a pretty good return on that.

As I mentioned, we did change agencies to get a specialist in digital online marketing back in the fall. I think that's had a positive impact as well because, as you may aware, these are very sophisticated algorithms to target patients, lookalikes compared to people who've already clicked on ads.

So I think between the increased spending -- also, I think consumer behavior, I'm optimistic, has changed more positively. People are more confident about their health situation or about their job or their spouse's job who might have the health insurance to cover their MyoPro. So I think maybe that has led to more click-throughs on our ads in the last couple of months.

Okay. And you mentioned that you continue to sell product into O&P. How is that part of the business doing for you guys?

Well, that part of business continues to generate sales for us. It's a smaller percentage just because our direct billing activity, driven by our own direct marketing, has accelerated and taken over 3/4 of the revenue stream here. But we still have a number of patients in that pipeline that are O&P providers in the United States.

And then outside the U.S., we work exclusively through orthotics and prosthetics providers. We have a whole network of those O&P providers in Germany, some in the U.K., Australia as well. So again, as Dave mentioned, the O&P business, both U.S., internationally, plus VA, where we sell to directly, is about 1/4 of our business.

And are you waiting to see how your experience in Germany goes in terms of how well you can get into that market before you spread into other European markets? Or are you kind of doing it in tandem?

Well, we're well positioned in Germany. We're getting more of these statutory health insurance payers to pay for this. And again, it's a deep pool of patients in Germany. It's the biggest country in the EU. It's got the best reimbursement for high-tech devices.

And so our goal there -- we just hired another person there to help us penetrate that market. Opening up new countries requires an investment. We're talking to O&P providers in a couple of other countries. But for right now, Germany will be our key market. U.K. is opening up again. We've got a screening day going on there as well.

Okay. And the previous caller had mentioned the length of time between the inquiry and when you can actually book it as revenue. But what's the typical length of time between like -- between inquiry and when the patient is confident that they can actually get the device? Is it pretty similar or --?

So if you look at that 6- to 12-month cycle time we quote, let's say you contacted us today. Our call center in Fort Worth, Texas would be back in touch with you very quickly. We'd arrange for a telehealth initial evaluation, which could be done in a few days.

Then we need you to go to your doctor's office to get all your chart notes about your previous treatments such as occupational therapy. You need a prescription, a letter of medical necessity. That could take a few weeks. Then we get that submitted to the insurance company for you. And that approval by the insurance company, it could happen within 30 to 45 days on the first pass.

Some insurers will kick it out as not approved or denied, and therefore, we have to craft an appeal. That could take 30 days to do that. It may be approved at that point. If it's denied a second time, we may have to go through an administrative law judge hearing, which we then prepare the case for that. Our team will then conduct that appeal.

Once we get that approval, then we have to arrange to visit with you in-person, take a cast of your arm, other measurements. And then we get the device fabricated, then we set up a follow-up appointment to actually deliver the device, configure all the software settings. So again, you just look at the time elapsed there, it's about 6 to 12 months and sometimes longer.

Yes. And just if you were to split it out, the -- and break the pipeline up between what's -- when we receive an authorization to when it becomes revenue, that's somewhere in the neighborhood of, say, 3 to 4 months. It can be shorter sometimes, but, call it, 3 to 4 months. And then the rest of that 6 to 12 months is in the part from the time the lead is generated to the time we get the authorization.

And do you find that you lose a lot of patients between inquiry and when you get the authorization? Or not really?

Yes. We find that there -- and this was -- one of the earlier questions dealt with that point. There's in general about a 10% to 20% dropout rate in the pipeline each quarter. That comes from people that we -- they'll drop out for various reasons, insurance reasons, health reasons, can't get a hold of them, what have you. It can be all kinds of reasons. And we find that that's the rate at which -- and it's been fairly consistent at which people will drop out.

Okay. And the last question, what is the average out-of-pocket for people?

These are -- because we're on a case-by-case basis, we don't have contracts with insurers every -- unless they've reached their out-of-pocket maximum. And that's the sort of the key thing, whether they have an out-of-pocket maximum or not. And besides that, it's probably going to then be 80-20. But it depends on the state of that patient's out-of-pocket maximum.

(Operator Instructions) And the next question comes from Orin Hirschman with AIGH Investment Partners.

You had alluded to some additional futuristic products, I mean, besides the pediatric product. Any more specific you can be in terms of what else you think you could do or what's in the pipeline, et cetera?

Well, we're looking at how do we continue to enhance the existing MyoPro device. And then we're always starting to think about, okay, what's the next-generation product? But we're going to focus on the upper extremity because there are lots of different alternatives for the lower extremity from AFOs, ankle-foot orthoses; to wheelchairs; to canes; and exoskeletons.

And so we're looking at what should be that product mix going forward? Are there other new types of sensing technologies that we ought to incorporate into our devices? So all I can say is we have planning sessions on those. And the typical development cycle between conception, prototyping, patient testing, validation, supply chain, it's typically 18 to 24 months before a new product can be introduced into the marketplace per FDA regulations.

In terms of the additional sensing technologies. You mentioned [what had] been televised, what -- where is your IP, in there? Or is the critical IP really coming from the outside where the brainwaves are being monitored? Where does that dovetail with your electrical stimulation IP and understanding?

Well, yes, our IP is centered around using the body's electromyogram, EMG, signals to power an orthotic device. So -- and the most recent patents, which go out to 2039, cover multiple joints, which we think is important. So it's not just a hand component, but you've got to have the elbow for -- to be able to reach and grasp items.

So that, plus our IP around the control algorithms because, yes, this is very sophisticated software to be able to decipher, filter, sample the body's EMG signals to have a true high-fidelity motion, which the patient wants to have.

And so in terms of the one that's controlled by brainwaves, for example, what outside IP or technology would you need in that case that is proprietary that you don't have today? Or have you licensed it in today if you don't have it today? If I may ask that one last question.

Yes. So there are some of these experimental projects where -- like at Thomas Jefferson and you've got Neuralink that -- they're using brain implant electrodes. Well, that's going to be their intellectual property.

What we have is an API, an application program interface, where we can take those signals, whether it comes from that type of electrode or our own sensory electrodes to power the device. So we kind of look at it as we've got a platform that in the future, multiple sensor technologies could drive that for the patients.

Okay. Is there an important -- so if I can follow up on that. Is it important for you to own the other sensor technology and the other sensory technology? Or that's not so critical? Or you are open to that? What's the general thoughts and plans?

Well, each of those are going to require substantial investments and a long time to commercialize those. So our view is we are partnering with these other entities to make our API open to them, so we can take the signals they generate and drive our device. And again, focus on -- our control algorithms don't change. It's just a different input mechanism.

And this does concludes the question-and-answer session. I would like to return the floor to management for any closing comments.

Well, thanks. Well, in closing, we're optimistic that the economy here and in other countries is going to continue to open up and that the pandemic will abate over the course of the year. And assuming that's the case, we can expect continued patient pipeline growth and record strong annual revenue growth for the fifth year in a row.

We're addressing a large unmet need with a life-changing solution while continuing along the path toward our next milestone of breakeven cash flow from operations. So again, thanks for your time and for your interest in Myomo. Have a good evening.

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