Good evening, ladies and gentlemen, and welcome to the Third Quarter of 2020 Earnings Conference Call for Tactile Medical. [Operator Instructions].

Please note that this conference call is being recorded and will be available on the company's website for replay shortly.

Before we begin, I would like to remind everyone that our remarks and responses to your questions today may contain forward-looking statements that are based on the current expectations of management and involve inherent risks and uncertainties that could cause actual results to differ materially from those indicated, including those identified in the Risk Factors section of our annual report on Form 10-K as well as the most recent 10-Q filing filed today with the Securities and Exchange Commission.

Such factors may be updated from time to time in our filings with the SEC, which are available on our website. We undertake no obligation to publicly update or revise our forward-looking statements as a result of new information, future events or otherwise. .

This call will also include references to certain financial measures that are not calculated in accordance with generally accepted accounting principles or GAAP. We generally refer to these non-GAAP financial measures.

Reconciliations of these non-GAAP financial measures to the most comparable measures calculated and presented in accordance with GAAP are available in the earnings press release on the Investor Relations portion of our website..

I would now like to turn the call over to Mr. Dan Reuvers, Tactile Medical's President and Chief Executive Officer. Please go ahead, sir. .

Thank you, operator. Good evening, and welcome, everyone, to our third quarter 2020 earnings call. I'm joined on the call today by our Chief Financial Officer, Brent Moen. Let me provide you with a brief outline of today's call.

I'm going to begin with a brief recap of our Q3 revenue results before shifting to a more detailed update on how the COVID-19 pandemic impacted our financial and operational performance during the quarter.

I'll also discuss the activities that our team has been focused on to help mitigate these impacts and continue to serve our clinicians and their patients. Brent is going to discuss our financial results in detail and review our financial guidance for 2020, which we've reinstated and updated in our earnings press release this afternoon.

Following his remarks, I'll then share a few closing thoughts on our outlook before we open the call for questions. So with that as a backdrop, let's get started..

For the third quarter of 2020, we reported total revenue of $49.1 million, which represented a decrease of 1% year-over-year on a reported basis and flat on an operational basis. We experienced a strong recovery off the low of Q2 of '20, as evidenced by our 40% sequential improvement over the prior quarter.

The decrease in total revenue was driven by sales and rentals of our Flexitouch systems, which decreased 4% year-over-year. This was partially offset by strong sales and rentals of our Entré systems, which increased 26% year-over-year..

While we continued to experience significant business disruption as a result of the COVID pandemic, our overall performance during the quarter exceeded our expectations.

Turning to a more detailed discussion of the ebbs and flows related to COVID, although we continued to see uneven performance across different geographies and sites of care, overall, we were pleased to observe the several positive trends during the quarter.

The vast majority of our top accounts were open in treating patients throughout the quarter, and access to clinician prescribers has greatly improved relative to Q2. .

We saw many clinicians and facilities continue to demonstrate progress in adapting to the new environment under COVID and manage as best they can. And most importantly, feedback from our prescribers during the quarter indicated that they're experiencing strong demand as patients are returning to seek treatment.

Despite these positive trends, we saw that health care facilities continued to operate with constraints related to health and safety protocols adopted in response to COVID..

As we found in our most recent October survey of our top accounts, about 75% of those nearly 1,400 surveyed accounts that were open reported that they were operating with constraints. These constraints are impacting our business in 2 primary ways.

First, while practices have reported that they're seeing no shortage of patient demand, their capacity to treat patients remains impaired, with many clinics reporting that they're operating with fewer exam rooms, requiring additional time to clean and turn over rooms and experiencing extended periods between patient consultations.

Second, excluding VA hospitals, our call points have largely relaxed restrictions to enable rep access to their clinicians. However, many continue to restrict our sales reps from conducting in-person patient demos..

Historically, our sales force conducts in-person demonstrations with lymphedema patients at the clinic, providing them with the ability to try on our Flexitouch or Entré systems and experience a brief treatment session.

The ability to experience the benefits provided by one of our systems' firsthand is an important event in the sales process as it engenders familiarity and conviction on behalf of the patient.

While we've seen meaningful recovery in business trends overall during the third quarter, we believe these social distancing and safety protocols remain a headwind as the U.S. recovery continues to see traction..

In terms of the trends that we've seen by site of care, privately owned practices based in the outpatient setting, particularly vascular clinics, continue to lead the way in terms of recovery.

These clinician customers appear to have relatively fewer and less severe COVID-related restrictions governing their approach to interacting with patients and sales reps as compared to large universities and health systems.

They also continue to demonstrate more entrepreneurial resourcefulness in terms of their approach to seeing patients with many extending office hours and even limiting vacation time. .

Meanwhile, hospital and health system-based therapists are recovering more gradually as they tend to have more stringent restrictions governing their activities, including constraints limiting patient volumes.

In the VA specifically, many of the 170 VA hospital centers continue to redirect lymphedema patients to their network of over 700 community-based outpatient clinics where they're commonly seen by primary care physicians.

This dynamic has required our sales force to expand their focus outside of the VA centers and clinicians that they would traditionally call upon..

Across the board, I'm pleased to report that our team is performing admirably, staying resourceful and adapting their approach to suit the current environment.

Our sales force continues to do an impressive job of supporting and assisting our existing clinicians and their patients via virtual means where necessary, including conducting virtual product demonstrations.

From a patient training standpoint, we continue to see success with our expanded menu of patient training options, which we implemented last quarter in order to accommodate our patients' desire to maintain social distancing..

In addition to traditional in-home training, we're providing patients with out-of-the-box instructional materials, including video tutorials and a quick start guide to help them easily familiarize themselves with the use of our systems and enable them to begin self-treatment immediately.

We're also conducting patient trainings virtually, which have been exceptionally well received. In our recent patient experience surveys, virtual trainings earned satisfaction ratings that were consistent with our traditional in-home training..

Our surveys also found that patients were equally as likely to recommend our products regardless of whether they received in-home training or virtual training.

We view these results as a positive sign and affirmation that we're continuing to ensure the best patient experience possible despite this necessary shift from our traditional patient training process..

And lastly, in addition to supporting our existing clinicians and their patients, our team has made impressive progress in targeting and engaging new clinicians to expand our prescriber base, in part, by leveraging virtual engagement.

During the third quarter, we developed and organized nearly 25 virtual education events, either independently or in partnership with key opinion leaders in our industry.

These educational events are focused on a variety of clinically relevant topics, designed to inform various audiences within our universe of potential prescribers and health care providers.

Depending on the focus and intended audience of each event, our sales team is tasked with inviting targeted clinicians and then following up to obtain their feedback and explore how we might become a tool within their treatment arsenal..

In comparison to our traditional in-person events, we've found that clinicians are more inclined to attend virtual education programs, in part, because they're more convenient and require a shorter commitment of time. During the third quarter alone, the events that we hosted drew participation from over 1,000 clinician attendees.

Year-to-date, we've had over 5,000 attend our clinical education events, more than double all of 2019. The overall, these events have received very positive feedback, and we've seen evidence of new clinicians further demonstrating their interest and engagement..

Ultimately, by leveraging these virtual education events and our account-targeting activities, our team has been able to drive strong increases in our base of prescribers, which has helped us partially offset the impact of COVID on clinic throughput and rep access to patients.

We believe this expansion of prescribers will support our longer-term growth as the impact of COVID subsides and our universe of uninhibited prescribers expands. Stepping back, we've come a long way from the most impacted months of the COVID pandemic this past spring even as cases continue to surge.

In the third quarter specifically, we were pleased to see essentially flat sales growth on a year-over-year basis even after experiencing mid-single-digit sales declines in July..

Our team continues to demonstrate its ability to identify and execute innovative solutions to mitigate the challenges presented by the pandemic while continuing to provide world-class service and support for our clinicians and patients.

And lastly, we believe the continued expansion of our prescriber base is perhaps our most notable accomplishment during the quarter and one that will bode well for the long-term success of our organization as the market environment continues to improve. .

With that, let me turn the ball to Brent to unpack our third quarter financial results in greater detail and discuss our 2020 guidance, which we reinstated and updated in our press release this afternoon.

Brent?.

Thanks, Dan. Total revenue in the third quarter decreased 1% on a reported basis to $49.1 million compared to $49.6 million in the third quarter of 2019. Total revenue growth was flat year-over-year on an operational basis.

As a reminder, our operational revenue growth excludes the impact of the ASC 842 accounting standard, which favorably impacted our revenue in the third quarter of 2019..

Sales and rentals of our Flexitouch systems accounted for 90% of our total revenue in the third quarter of 2020 compared to 92% in the prior year period. Third quarter 2020 revenue by payer was 70% commercial, 16% Medicare and 14% VA compared to 72%, 12% and 16%, respectively, in the third quarter of 2019..

Turning to the rest of the P&L. Third quarter gross profit decreased $400,000 to $35 million compared to $35.4 million last year. Gross margin was 71% of sales in the third quarter of 2020, consistent with the same period last year. Third quarter operating expenses increased $1 million or 3% to $33.2 million compared to $32.2 million last year.

The increase in operating expenses was primarily driven by higher reimbursement, general and administrative expenses, which increased $2.6 million or 26% to $12.6 million compared to $10 million last year.

This increase was driven by increased occupancy costs, depreciation expense, legal and professional field -- fees and compensation expense in our reimbursement and corporate functions.

The increase in operating expenses was partially offset by a decrease of $1.2 million or 6% in sales and marketing expenses and, to a lesser extent, a decrease of $365,000 or 25% in research and development expenses. .

Operating income in the third quarter of 2020 decreased $1.4 million, or 44%, to $1.8 million compared to $3.2 million in the third quarter of 2019. Income tax benefit in the third quarter of 2020 was approximately $750,000 compared to income tax expense of approximately $930,000 in the third quarter of 2019.

The change in income tax expense and benefit was primarily due to a change in our effective tax rate, which was attributed to a change in projected taxable income, including proportionately higher tax benefits for stock-based compensation as compared to the same period last year..

Net income for the third quarter of 2020 was $2.4 million, or $0.12 per diluted share, compared to $2.4 million, or $0.12 per diluted share, for the third quarter of 2019. Weighted average shares used to compute diluted net income per share were $19.7 million and $19.6 million for the third quarters of 2020 and 2019, respectively..

Third quarter adjusted EBITDA was approximately $6 million compared to adjusted EBITDA of $6.4 million in the third quarter of 2019. As a reminder, we have provided a reconciliation of certain GAAP measures to non-GAAP measures in our earnings press release..

September 30, 2020, cash, cash equivalents and marketable securities were $42.2 million compared to $45.2 million at December 31, 2019. We had no outstanding borrowings on our $10 million revolving credit facility at quarter end.

We continue to believe that our balance sheet and financial condition leaves us well positioned to fund our growth strategy..

Let me now turn to a review of our updated 2020 guidance, which we provided in our earnings release this afternoon. For 2020, we expect total revenue in the range of $184.9 to $186.9 million, which represents a decline of 1% to 2% year-over-year compared to revenue of $189.5 million in 2019..

As a reminder, in connection with the adoption of ASC 842, our full year 2019 revenue included approximately $5 million of rental revenue related to operating leases, which will not contribute to the company's revenue results going forward.

Excluding the contribution to full year 2019 revenue from our adoption of ASC 842, the 2020 revenue range reflects year-over-year growth of approximately 0% to 1% on an operational basis..

We have included a reconciliation table detailing the projected 2020 GAAP revenue growth rate to the projected 2020 non-GAAP revenue growth rate in our earnings press release this afternoon..

Turning to the P&L. For full year 2020, we expect our gross margin to be in the low 70% range and our adjusted EBITDA margin to be in the range of 7% to 8%. This adjusted EBITDA range assumes depreciation and amortization expense of approximately $2.8 million, stock-based compensation expense of approximately $11.6 million.

And for the purposes of calculating earnings per share, we expect our fully diluted weighted average share count in 2020 to be approximately 19.5 million shares..

With that, I'll turn the call back to Dan for some closing remarks.

Dan?.

Thanks, Brent. Our updated revenue guidance range implies a modest return to growth in Q4 on a year-over-year basis. And our decision to reinstate guidance today reflects our incremental confidence in the improved stability of our business as we enter the fourth quarter.

While clinic capacity and our reps' access to patients remains inconsistent as a result of the dynamics I discussed earlier in my remarks, we continue to be impressed by our team's ability to help offset these impacts by supporting our customers and expanding our pool of prescribers..

Importantly, with over $42 million of cash and no debt at quarter end, we remain well capitalized and well positioned to continue investing in our business even in the face of future COVID-related headwinds.

Given our strong balance sheet condition, we remain focused on investing strategically in our business as we continue to pursue the relatively untapped $5 billion market opportunity for lymphedema in the United States..

educating clinicians and introducing new patients to our potentially life-changing therapies. .

With an eye on our longer-term market development efforts, we will also continue to invest in key areas, including clinical evidence and clinical education that will position us to further increase the awareness of lymphedema and establish the clinical benefits of our technologies with clinicians, payers and patients in the years to come.

Through our continued execution and strategic investment, Tactile Medical is focused on returning as quickly as possible to our long-term track record of strong, sustained growth and improving profitability. .

Before I open the call for questions, I'd just like to share that it's been a real pleasure to work alongside the exceptional team here at Tactile Medical during the last several months.

I'm incredibly proud of the dedication and entrepreneurial spirit our team has shown in the face of the most challenging circumstances, along with their clear passion for improving the lives of the people we serve.

I'd also like to thank our customers and shareholders for their support and those on this evening's call for their interest in Tactile Medical. .

Operator, we'll now open the call for questions. .

[Operator Instructions] And our first question comes from the line of Margaret Kaczor with William Blair. .

First one for me just because I got to hit it, on the fourth quarter, we're now through October. We're seeing some bigger waves come through. You guys still kind of reinstated guidance, but I assume things get better.

So what's the potential likelihood of something close to a July scenario or things truly getting better? And then kind of a similar aspect on the bullish side, does that guidance assume any change in terms of underlying environment for patient visits or physician throughput or some of the new accounts you guys have been adding?.

Yes. Thanks for the question, Margaret. I think for Q4, one, we were happy to be able to provide a little bit more color as far as the range and what we expect. I think some of that comes largely from some of the familiarity that we're starting to gain with the circumstances, I think, we're finding ourselves in.

We do continue to survey our customers, as we mentioned, and the most recent one in October, I think, reflected much of what we had been seeing as we exited Q3, and that's largely that most of our customers were open for business again.

As I mentioned in the prepared remarks, the throughput, which we've spoken about, I think, even back in Q3 continues to be something that we're finding some balance in..

I think the -- one of the keys was the fact that while virtually all of them are open, about 3/4 are declaring that they're still performing with some operating constraints. And I think that we've seen continued improvement in Q3, which is kind of what we've called for kind of progressive improvements from the mid-single digits down of July.

We were pleased to actually see a little bit better than that, which allowed us to finish flat, meaning we were a little above last year in the back half. And I think that those are the variables that I think have put us in a position where we think we can provide some guidance again..

I think the patient demand is also the encouraging one, along with the fact that the prescriber pool expanding as a result of some of these education events are the offset that we think kind of can fill some of the gap where some of our current prescribers just haven't quite gotten back to their normal volumes yet.

So I think it's just a couple of points of color. I might ask Brent if he has anything he wants to add. .

Yes. I would -- Margaret, it's Brent, by the way. I would just remind you that even though we've provided guidance, certainly, we don't have a crystal ball in terms of the impact of COVID. And so current spikes or additional spikes that maybe aren't on our radar certainly may provide some incremental headwinds to the guidance we've provided.

But based on where we're at right now, some of the fog is lifted and feel good about the guidance that we've put forth for the remainder of 2020. .

Okay. Very helpful. So I want to maybe move to the virtual events. You guys have put up some pretty big numbers in terms of virtual attendees and just, I think, 5,000 was the number I heard over the course of the year.

So let's talk about that, both on impact on 2020 and the ability of your sales reps to be able to hit all of these new potential accounts.

So how should you commercialize around them, particularly as we enter 2021? As I assume these should be bigger drivers as we go into next year?.

Yes. So the virtual professional education has probably been one of the bigger wins for us this year. I think the marketing team and clinical team did a fantastic job of pivoting and making sure that we had the ability to produce really good scientific presentations. And I think that's really a testament to why we're getting such good attendance.

It's not just about the convenience factor that it's easy to log in to a Zoom from someone's home than having to go to a physical event either across town or across the country. But we continue to see really good draws because the quality of the presentations, I think, has been commensurate with the kind of interest that we've been able to generate..

We had -- in Q3, we hosted about 25 events. About 1/4 of those were hosted by key opinion leaders. So these could be vascular surgeons, radiation oncologists and the likes that presented, based on their experience, here's what you're looking at, here's how to diagnose, here's some of the scenarios.

There's a lot of pictures of different kinds of patients. They talk about what the underlying premise is for one patient versus another and associate the visual component. And I think that those that are attending it are finding it very, very helpful..

The other 3/4 of those were hosted by our in-house, what I'll call, talent, but those are clinicians that happen to be on staff and share some of the same kind of educational content.

And I'm really of the mind that this has been such an important driver for us because it's helping us to expand our way into new prescribers, and we've talked so much about that this is a market development story. We still believe that the majority of patients we can help have still not been recognized or treated.

So this is an important part of expanding the universe of prescribers. And while it doesn't necessarily show up yet on the top line, we know that it's filling the gap of those that are active prescribers but not able to see as many patients.

And that's why, as we commented on, I really believe as the pressures of COVID subside that having a broader roster of prescribers is going to serve our recovery to growth very well. .

Our next question comes from the line of Matthew O'Brien with Piper Sandler. .

I guess just a follow-up on Margaret's question.

Maybe, Dan, just in terms of the increase in the base of prescribers, can you give us a sense for how much bigger is it? Is it 20%, 30% bigger than you kind of came into the year? And then how do you think about covering all those new prescribers? Do you need more sales reps? And are they the higher-volume prescribers? Are those the ones you've really been targeting and then seeing come on board? Or is it just more of a mix across the volume spectrum?.

Yes. Thanks for the question, Matt. As far as the number of prescribers, I don't think we're ready to start to disclose numbers on new prescribers, but it's been meaningful, clearly, as we see the throughput down as much as double digits with our current base, this has been an important contribution to our results..

As far as who is participating and what kind of activity are they able to generate, you can imagine these are not the highest prescribers initially.

So typically, when you get a new prescriber, more often than not, they're going to want to prescribe 1 or 2 patients that we've helped them identify that maybe they've missed or that they've seen recently and now are familiar with our options. And based on what they've heard and learned, they'll often give us 1 or 2 patients and see how they respond.

As we're able to demonstrate good outcomes, it becomes a much more regular part of their arsenal.

So these are typically prescribers that are going to be lower volumes initially like most that would come on, but we would certainly expect like other prescribers as they continue to see the successes of pneumatic compression on their patients that they can be the growth sources of the future..

I think another example is on the VA side because we've seen the movement to community-based outpatient centers instead of the VA centers. Now these patients are often being triaged through a primary care physician. So intentionally, we hosted an event targeted specifically to the primary care doc.

It was a bit more basic introductory material than it would have been for the advanced vascular surgeon. But I think that trying to match up the right kind of content with the target prescribers is one of the things that's led to some of the success. .

And Matt, it's Brent. I was just going to answer the second half of your question. We talked about sales force hiring [Audio Gap] productivity. So I'll just give you a quick rundown. So we finished September 30 at just over 250 sales reps out in the field.

We're targeting to get to 260, which would be an add of roughly 28 reps in 2020, which is our communicated goal. And so we continue to invest in our commercial organization, and we're thankful that our balance sheet allows us to continue to do that. .

Very helpful. And then as the follow-up, and I'm not sure if this is for Dan or for Brent, but can you just talk a little bit about the Actitouch strength that we saw in the quarter? It was really, really good. And I may have missed it if you said it in the prepared comments.

And then Brent, again, trying not to look too far into the future, but the Street's modeling some pretty healthy growth for '21 off of 2019 numbers.

Do you feel comfortable that with the prescriber increase and with things kind of stabilizing that you can put up really good future growth back quickly? Or are investors -- is the Street getting a little bit ahead of the recovery we should expect out of Tactile as we look into next year?.

Yes, Matt, it's Brent. So yes, you're right, we did have a really strong quarter with the Entré product. So Entré was actually up 26% or $1.3 million year-over-year in Q3. The faster recovery relative to Entré was seen in the vascular clinics, which helped drive that kind of nice Entré performance.

And just to keep in mind that vascular docs primarily see patients with lower extremity lymphedema and a higher portion of those lower extremity patients receive our Entré products versus the upper extremity patients..

And just an important note that Medicare was actually also up quarter-over-quarter in Q3. Medicare was up 30% or $1.8 million. And just as a reminder, Medicare patients typically are required to try our Entré 651 device before they become eligible for Flexitouch.

So I think that, in combination, helped drive pretty strong performance in that Entré line..

And then just to answer your question relative to 2021, we're just getting our feet wet with reinstating 2020 guidance. So our commentary is that we expect to return to growth in Q4, which we also reiterated that, that was our expectation and goal coming out of our second quarter call.

So -- but right now we're not in a position to be able to provide much 2021 expectation. .

Our next question comes from the line of Ryan Zimmerman with BTIG. .

And congrats on better recovery, I think, than we expected. Maybe just start with the VA a little bit, Dan and Brent. Last quarter, we left and you're having some challenges with the reps getting into the hospital sites that are being pushed to the clinic.

So how has that changed? Or how has that played out through the third quarter? And kind of what are your expectations there in that channel in terms of getting back to those hospital sites for your sales reps?.

Yes. Thanks for the question, Ryan. So I think the news on VA is there's not a ton of news. We haven't seen much change in posture over the last few months since COVID set in.

I think just for all the listeners to remind, VA took a pretty swift posture change once COVID was introduced and redirected all their patients, at least those outpatients that we would typically see to those outpatient centers. And that's really where they continue to be seen. I think just some specifics on VA's performance.

It was down $1 million over prior year same quarter, but we were up 50% versus the second quarter. So I think while we didn't get our chin back to the 2019 levels, it was pretty pleased to see that it even recovered faster than our overall business, which moved up 40% since second quarter to the third quarter.

And I think some of that has to do with we're getting better acclimated at how to call on those C-box. As I mentioned, we've had some educational events targeted a bit more to the earlier prescribers, meaning primary care physicians.

And I think with the addition of some efforts to try and recover that business, I think those have been primarily the drivers. .

Okay. That's helpful. And then just as a follow-up for me. When I go back to second quarter and you surveyed the accounts, I think they state that your clinics stated that patient throughput was down even as they opened. I think that was consistent with what you saw through this quarter.

But what are the implications of that in the patient base? I mean as they wait for care, are you seeing more severe cases kind of build? You did call out the fact that demand hadn't waned.

And so does that create an opportunity for maybe more advanced patients or for a higher level of pneumatic compression in this channel over the next quarter or 2 as you kind of work that demand down back to normalized levels?.

I think that remains -- that's a really good question. I think it remains to be seen. The answer is probably perhaps. But I think there's a plenty of a queue available. And if you're a vascular surgeon, where we're actually seeing the fastest recovery, they have a pretty broad mix of patients they're seeing. Some are surgical candidates as well.

So I think their interest in seeing the full mix certainly serves their business well. But I think the good news that we've been focused on is simply the patient demand seems more than adequate to fill their days..

And I think that as they continue to expand capacity, those patients that we can help will continue to grow. In the meantime, I really can't understand -- I really think it's very important for us to continue to expand this pool of prescribers.

And again, while I think we will have a headwind for some near-term foreseeable future, I think the fact that we're finding additional prescribers is going to be an important part of our ability to recover as we get beyond some of the COVID headwinds and also to recognize more of these unrecognized patients to date. .

Our next question comes from the line of Chris Pasquale with Guggenheim. .

This is Chris Hartstein on for Chris Pasquale. Are you able to parse out what percent of 3Q volumes consisted of previously deferred treatments? And do you expect the continuation of this dynamic as you work through your patient backlog in 4Q? And I have a follow-up. .

Chris, Brent Moen here. And, yes, as it relates to your question on Q3, no, we haven't disclosed the kind of patient mix for Q3 volumes. So difficult to comment on that particular point, but continue to see strong patient demand from those that are interested in seeking treatment for lymphedema.

And so that's a positive for us currently being impacted, as Dan said, by patient throughput, but encouraged to see the recovery from the patient side for sure. .

That's good to hear. As a follow-up, so historically, you've grown OpEx at a rate consistent with your top line growth. But given the size of the lymphedema opportunity, you've invested throughout the downturn.

As you look out to next year, do you expect OpEx to grow in line with sales? Or the investments you made this year allow you to spend at a rate below that?.

Yes, it's a great question. So a couple of variables that are out there. And by the way, this -- Chris, this is Brent, again. A couple of variables that are out there. We continue to invest in our commercial and sales marketing line of business.

So there's a fairly sizable opportunity that's in front of us just by evidence by the TAM that exists or the $5 billion market share opportunity out there. So we're going to continue to take advantage of that.

So I think what you'll see is continuing investing in sales and marketing, ability to leverage some of the other categories out there, so think of it in G&A and reimbursement, we've made the primary investments in both of those categories. So we'll continue to spend, but there will be leverage that we'll continue to get out of those areas.

And I think Dan's commented on the Q2 call that there might be an opportunity to step up our investment on a small scale in R&D over the course of the next several years, but continuing to drive increasing leverage through 2021. .

And can you provide an update on when you plan to publish the [ pair of ] head and neck studies? And are you still on track to apply for a new head and neck code early next year?.

So there've been a couple of studies that have been published this year thus far for head and neck.

In March, there was one actually published in head and neck, 205 patients, describing the improvement statistically significant as they were in the ability to improve swallowing, reduced pain, improve the ability to breathe and even perform daily activities.

Then there was the RCT, or the randomized clinical trial, that we revealed in June that was hosted or done by Vanderbilt in Southern Illinois University. That one was published in supportive care in cancer, and it compared advanced pneumatic compression, namely Flexitouch, to standard of care.

That, too, had statistically significant improvements in reductions in swelling and pain and the ability to swallow. These are -- as I've said many times, these are not cosmetic issues, these are real patient issues that we're trying to solve..

As far as how '21 will play out, I think '21 will very much be positioning ourselves to get the kind of reimbursement in place that will allow us to kind of lean into this even more aggressively. I suspect '21 will continue to show growth in head and neck, but I don't think it will be a material driver of our growth in '21.

I think it's going to be more a '22 factor, and we think that some of the things that we're going to be doing to position ourselves with some of the key payers likely to come late '21 as opposed to the early part of that year. .

Our next question comes from the line of Kyle Bauser with Dougherty & Company. .

Maybe I'll stick to the head and neck opportunity and, in particular, the RCT that came out in June. Of course, lymphedema increases after radiation therapy, which is when the patients were enrolled in this trial. And as you've outlined, there's a clear benefit when using Flexitouch.

But I suppose I didn't fully appreciate the observation in the paper that lymphedema many times is present at the time of cancer diagnosis before treatment. And it seems like the earlier lymphedema is addressed, the better, of course.

So is there an opportunity to capture these patients earlier in the treatment paradigm? Maybe you already have and might, in a future trial, enroll earlier? Or is the key focus really just post-radiation treatment?.

So I think -- it's really good questions. I think, first of all, it's worth noting that while we speak about head and neck, I think the whole oncology space is a broader and important one for us. So I wouldn't just limit, I think, our enthusiasm to where we can help patients to head and neck.

The whole breast cancer survivor patient pool, along with other cancers, all can result in some kind of lymphedema..

I think as it relates to head and neck, you're on to something. And we've -- I've spoken to some practices where they're actually trying to recognize it earlier in the benchmark. They're trying to establish what's the baseline for a patient immediately postsurgical even before they perhaps demonstrate symptoms.

And in doing so on their ongoing following of the patient, it's easier to identify lymphedema symptoms earlier. And I think we all know like most disease states, certainly a chronic one like this, the earlier one can intervene, the more likely they're going to be able to limit it from becoming more severe..

So this is a really important one. And I think that as we continue to demonstrate a mass evidence, we're optimistic that we'll be able to get other oncology programs to start to look for some of the markers for lymphedema earlier in their care cycle, and I think those things can certainly lead to managing the disease more effectively. .

Got it. That's helpful. And secondly, on the same paper, I noticed adherence to the twice daily regime was slow. Basically, most patients who are in the treatment arm only use Flexitouch once per day, not twice, yet, the results were still highly significant.

So I'm just kind of curious what the solution here is that, is once per day okay? Or can the time per treatment be reduced? Or is education to improve patient compliance to twice per day the more important issue? Just kind of curious how you're thinking about this?.

Yes. I would say we don't have a horse in the race on how many times we want them to use it. What we want to do is make sure that the use of it is effective and produces the results. So part of the reason that we start out with smaller numbers is to start to understand a bit more about the dynamics, who responds, et cetera.

And then it allows us, I think, to shape broader studies with a bigger end to make sure that we've learned enough so we can actually ask the follow-up right questions.

Examining what's the right number of treatments per day, I think, is the kind of thing, among others, that would probably get shaped in a subsequent protocol based on the learnings from some of these pilot studies. .

[Operator Instructions] Our next question comes from the line of Suraj Kalia with Oppenheimer. .

[indiscernible].

Suraj, are you out there?.

[indiscernible].

Suraj, we can't hear you. .

Our next question comes from the line of Mike Ott with Oppenheimer. .

Wondering if you could just update us on the status of the qui tam lawsuit if possible. .

Sure. Happy to do that, Mike. So I will tell you that there hasn't been a lot of new news since our Q2 update. Probably the biggest update is, on September 8, we actually filed a motion for partial summary judgment. So there's 2 things that are pending judge decision at this particular point.

One is they, meaning the plaintiffs, back in May actually put in a motion to dismiss our counter claims. And then on September, we filed that motion to -- for partial summary judgment. So those are the 2 things that are actually pending decision by the judge. Right now no change in the outlook relative to when it goes to trial.

So we're expecting a trial date sometime in late Q1, early Q2. So think of April or May of 2021, and obviously, as you might expect, we think the claims are without merit, and we continue to vigorously defend them. So that's the update on the qui tam lawsuit. .

This does conclude our conference for today. Thank you for your participation, and have a wonderful day..