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Tactile Systems Technology, Inc. (TCMD)

Q4 2019 Earnings Call· Thu, Feb 27, 2020

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Transcript

Operator

Operator

Good afternoon, ladies and gentlemen, and welcome to the Fourth Quarter of 2019 Earnings Conference Call for Tactile Medical. At this time, all participants have been placed in a listen-only mode. At the end of the Company's prepared remarks, we will conduct a question-and-answer session. 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 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 the Generally Accepted Accounting Principles or GAAP. We generally refer to these as non-GAAP financial measures. Reconciliations of those 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. Jerry Mattys, Tactile Medical's Chief Executive Officer. Please go ahead, sir.

Gerald Mattys

Management

Thank you, operator. Good afternoon, and welcome, everyone to our fourth quarter and full-year 2019 earnings call. I am 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 will start with a review of our financial performance highlights for the full-year 2019, during which I will also discuss the primary drivers of our revenue performance. Following this discussion, I will review our 2019 operating highlights and briefly summarize our sales performance during the fourth quarter. Brent will discuss our financial results in detail and review our financial guidance for 2020, which we updated in our earnings press release this afternoon. Then share a few closing thoughts on our outlook in 2020 before we open the call for questions.2019 was another year of excellent performance for Tactile Medical. For the full-year, we achieved revenue of $189.5 million, representing 32% growth year-over-year, coming in ahead of our guidance range for 2019, which we increased on our third quarter earnings call.2019 revenue growth was primarily driven by sales of our Flexitouch Plus system, which increased 30% year-over-year to $171.3 million. Sales of our Entre systems were also an important contributor to our total company revenue growth in 2019, increasing 54% year-over-year to $18.2 million.As a reminder, our revenue results in 2019 were impacted favorably by the adoption of the new lease accounting standard, ASC 842, which Brent will discuss in detail during his remarks. Excluding the impact of ASC 842, our revenue increased 28% year-over-year on an operational basis in 2019. Our revenue growth in 2019 benefited from several important drivers that we have shared with you on prior earnings calls.First and foremost, the expansion of our sales team was a strong contributor to our success in 2019. By…

Brent Moen

Management

Thanks, Jerry. Total revenue in the fourth quarter increased 23% to $57.1 million compared to $46.4 million in the fourth quarter of 2018. Our total revenue performance in the quarter was driven by an increase of $8.8 million or 21% year-over-year in sales and rentals of our Flexitouch systems and an increase of $1.8 million or 48% year-over-year in sales and rentals of our Entre systems.The increase in our Flexitouch revenue was largely driven by the expansion of our sales force, increased physician and patient awareness of the treatment options for lymphedema, broad in-network coverage with insurance payers and growth in the number of Medicare patients served.The growth in sales of our Entre product benefited from the strategic shift to manage these orders in-house as Jerry discussed earlier. Sales and rentals of our Flexitouch systems accounted for 90% of our total revenue in the fourth quarter of 2019 compared to 92% in the prior year.Fourth quarter revenue by payer was 75% commercial, 13% VA and 12% Medicare, compared to 70%, 18% and 12%, respectively last year. As discussed on our earnings calls throughout 2019, we adopted the new lease accounting standard, ASC 842, which became effective on January 1, 2019. The adoption of ASC 842 did not require us to restate any of our prior periods. The impact of the company's adoption of ASC 842 was not material to the year-over-year increase in total revenue in the fourth quarter of 2019.Turning to the rest of the P&L. Fourth quarter gross profit increased $9.1 million or 28% to $41.4 million compared to $32 million last year. Gross margin was 72% of sales in the fourth quarter of 2019, compared to 69% of sales in the fourth quarter of 2018.The increase in gross margin was primarily attributable to revenue mix by product…

Gerald Mattys

Management

Thank you, Brent. In summary, we are excited by the achievements we have made this past year, and in 2020, we look forward to continuing to drive commercial execution, operational progress, and increased awareness of our technologies in the market.Our 2020 guidance reaffirms our commitment to delivering 20% plus revenue growth and improvements in our profitability. The long-term goals we've executed against since our initial public offering in 2016.We continue to see compelling evidence as we did back then, that we are focused on a market that is both vastly under penetrated and expanding at an impressive rate. In December of 2019, we conducted another analysis of U.S. medical claims data, which showed that there were 1.3 million patients diagnosed with lymphedema in the 12-month period ending June 30, 2019, an increase of 18% in one-year.This updated analysis suggests that the annual number of patients diagnosed has grown at a compounded annual growth rate of 12% over the last 5.5 years compared to the 700,000 patients diagnosed in the 12-month period ending December 31 of 2013, which was the first period of data we evaluated.Importantly, the 1.3 million patients diagnosed represents a $5 billion plus addressable U.S. market opportunity, one that we believe remains very under penetrated with only 40,000 Flexitouch system shipped during 2019.In 2020, we will continue to capitalize on this vast opportunity by focusing on the primary drivers that have fueled our rapid growth in recent years. We will leverage our recent sales force hires and continue to expand our sales team headcount with the addition of approximately 20 new sales representatives with a goal of hiring the majority of these reps in the first half of 2020.We will continue to enhance the productivity of our sales reps by increasing our coverage and penetration of the high-diagnosing…

Operator

Operator

Thank you. [Operator Instructions] And our first question comes from Margaret Kaczor with William Blair. Please state your question.

Malgorzata Kaczor

Analyst

Hey. Good afternoon, guys. Thanks for taking the question. So maybe the first one for me is on guidance. So if we exclude some of the ASC 842 impacts, it looks like that's coming in the mid 20% range, which frankly is stronger than you guys have typically guided to at this point in the year. So I understand the sales or productivity improvement and so on that could drive that growth. But is that the main delta or is there something else you're seeing in the field that gives you greater confidence?

Gerald Mattys

Management

Hey, Margaret. Thanks for the question. We certainly like and believe that increasing the headcount in the field is a key driver of growth in 2020. I would say the productivity that we're seeing by both leveraging the in-house team to process those Entre and Medicare orders to free up product specialists time is working very, very well.And this targeting strategy which we've been talking about now for a couple of years is really starting to payoff. And you can see that in the data that I shared a little earlier. So I think our success in penetrating these important accounts, where we've gone from nearly half penetrated at the beginning of 2019 to now more than 60% penetrated at the end of the year, speaks well to why we are bullish about 2020 guidance.

Malgorzata Kaczor

Analyst

Okay. So that's helpful. And then that brings me kind of to the follow-up question, which has to do with kind of the high-diagnosing clinicians as well as the updates on TAM, both of which were very good. So the first part of the question is on the high- diagnosing accounts as the market growth is already high teens, these accounts are growing faster than that, which means that you guys get to benefit from that dynamic. But in terms of the growth drivers, how do we think about that helping that productivity and profitability for you guys?And then kind of the side question on TAM is that CVI-related lymphedema trial at 16 million patients is quite large. So what are the next moves that you guys need to make strategically to see a more material impact on numbers from that? Thanks.

Gerald Mattys

Management

Great. Thanks. Good couple of questions. On the first one, the new data, when we are able to convert one of these high-diagnosing clinicians to begin prescribing our Flexitouch system, they tend to order twice the amount of product as our average account. So this has been a very fruitful way to focus the sales team and get them to better utilize the time that they have. So the new data suggests growth in the number of patients diagnosed, the number of high-diagnosing clinicians, the number of clinics, and most importantly the number that we penetrated. So I think those are all very positive elements going into 2020.The second question was around that – the fact that CVI-induced lymphedema or Phlebolymphedema is traditionally not been thought of as the primary cause of lower extremity lymphedema. Our activities and our focus over the past 1.5 to 2 years has been on trying to reach the vascular physician. That vascular doc is the one who sees these patients with chronic venous insufficiency. So we're focused on them now and this just gives us more evidence to go into those accounts and help them see the lymphedema that they're seeing in these patients every day.

Malgorzata Kaczor

Analyst

Do you think the data is compelling enough to try to drive adoption? And is this specific data set just one of many? Or do you find it to be kind of a capitulating point potentially for growth? Thanks.

Gerald Mattys

Management

I think it's a nice inflection point for teeing up the awareness of lymphedema in this population of patients with poor circulation. So I would say that most vascular physicians don't look for lymphedema today. And with this evidence now, we can go in and convince them that they're missing it and that they have an opportunity to really be more aware of the problem and of our solution for this patient. So we're very excited about those new prevalence data.

Operator

Operator

Thank you. Our next question comes from Chris Pasquale with Guggenheim. Please state your question.

Christopher Pasquale

Analyst · Guggenheim. Please state your question.

Thanks. Jerry, you guys added about 40 reps in each of the past two years and it seems like there's still plenty of runway to expand your footprint if you're only calling on 60% of your potential customers. So what was the thought process behind dialing that back to 20 this year?

Gerald Mattys

Management

Hey, Chris. Thanks for the question. So we actually set out to hire 30 more reps in 2019 and ended up finding 10 more through our recruiting efforts and decided to bring them on ahead of time. So we've been saying about 30 a year is kind of the – what we'd like to be able to continue to drive toward. So that 10 plus the 20, we just mentioned in the call today, gets us to that 30 number. That's how we've been thinking about it.

Christopher Pasquale

Analyst · Guggenheim. Please state your question.

Okay. So you pulled forward some of the hiring from 2020 into the back half of 2019, essentially?

Gerald Mattys

Management

Into that last fourth quarter, actually, yes.

Christopher Pasquale

Analyst · Guggenheim. Please state your question.

Yes. And then my second question, so it looks like VA sales declined about 9% in the quarter. Could you talk a little bit about what you're seeing there? How much of that weakness is related to disruption from the Qui Tam suit? And with the suit now looking like it's going to take a little while to resolve how you are thinking about that segment of the business in 2020?

Gerald Mattys

Management

Yes. Good question. So sales to the VA in the fourth quarter were about $7.6 million of the $57.1 million we had in the quarter, so roughly about 13% of our sales. We did see a decline driven by underperformance in really just one of the regions of the company, which offset better results around the rest of the country.There is no doubt the Qui Tam lawsuit has impacted results again in the fourth quarter. But we had strong growth outside of those areas that weren't anywhere near the – where this was filed. So that's what has us optimistic about sales going into 2020. We don't really forecast or we don't really model by payer because we had shown the ability of our sales organization to pivot to the most – to the sales that are available in their specific territory. But we've experienced some really nice performance in the VA outside of that one region.So from a growth perspective, we're starting to lap that headwind, which started unfortunately at this time last year. And I would say one of the things that we're most excited about is we actually saw a new set of data presented in November at the VEF Conference in New York, which was the first VA specific data showing very compelling results for this veteran population.So we're now able to arm our 240 reps with new data that they can go back into the VA and make the case as to why Flexitouch is the right answer for this veteran. And I think that's going to get it back on a little bit more of a growth trajectory than what we saw in the fourth quarter.

Brent Moen

Management

Hey, Chris, it's Brent too. Just to kind of recap what happened also in Q4 of 2018. So if you recall in 2018 last – since September on, we got our Flexitouch Plus system on the Federal Supply Schedule, so it really drove what I'd consider to be higher than anticipated growth in the fourth quarter of 2018. So the comp comparison Q4 2018, Q4 2019 was a little distorted and certainly we don't believe that one quarter drives a trend in terms of where we think the opportunity lies in the VA.

Christopher Pasquale

Analyst · Guggenheim. Please state your question.

That's very helpful. Thanks guys.

Operator

Operator

Thank you. Our next question comes from Ryan Zimmerman with BTIG. Please state your question.

Ryan Zimmerman

Analyst · BTIG. Please state your question.

Great. Thanks for taking the questions. Excited to be on this call. So just to start, Jerry and Brent, Airwear will be immaterial this year, but if you could just talk about the recurring revenue opportunity for Airwear as you think about it, maybe in outer years. And what type of gross margin impact would Airwear potentially present for the company, good or bad to consider? And then I have a follow-up on head and neck. Thank you.

Gerald Mattys

Management

You bet. Thanks, Ryan. Appreciate the question, and happy to answer specific to Airwear. So as you may remember, we had a very limited launch going on in 2019 with very positive feedback from both clinicians and patients who used it during that time.We're on our way to a full commercial launch, but I think the thing that makes us most excited about this product is the fact that we get access to the patient earlier in their treatment cycle. And once we have patient access, we can begin educating them on what some of their other treatment options are, including our Flexitouch system.So it is true that these patients can get reimbursed for this product about an every six-month basis. And this would represent, what I would say, our first opportunity for some consumable type sales. It is a low average selling price, so we don't want to distract the sales organization too far off of their call point, when they have an opportunity to sell a Flexitouch.But because of its recurring nature, we're excited about what this can do for the company. We've said it's kind of immaterial for 2020 because we think it's going to take a while to catch on, but think it will be more meaningful as a contributor once we roll into 2021.

Brent Moen

Management

Hey, Ryan. It's Brent. So from a gross margin perspective, Airwear is in precisely the same ZIP code as our overall corporate gross margin. So don't anticipate that there's going to be any significant impact on gross margin as we rollout Airwear in 2020 and beyond.

Ryan Zimmerman

Analyst · BTIG. Please state your question.

Okay. Thank you. And then just my follow-up question. Head and neck, you guys called out as kind of being in the same – similar percentage of sales this year as it was last year. So applying growing in line with where the rest of the business is growing. But given the opportunity, you focused on clinical data, you have some more publications coming on the first half of this year. What is it that inflects your adoption in head and neck higher in your view as we move into the back half of 2020 and then into 2021? Thank you.

Gerald Mattys

Management

Yes. Really good question. So you summed up well that our current focus is on building the portfolio of clinical evidence to not only drive more widespread adoption of Flexitouch Head and Neck, but also give us the opportunity to gain expanded reimbursement coverage.You may remember that today we're only billing for the controller and we're not billing for the garments. We will certainly see our way to changing that and why we are so focused on publishing clinical evidence to allow us to approach CMS and ask for unique codes for those head and neck garments.We believe that will be a inflection point for the company's ability to convince more clinicians that this ought to be the product that they're thinking about for their patients with head and neck lymphedema. So we've published one study in the Journal of Otolaryngology-Head and Neck Surgery. We've got two more manuscripts that have been submitted and we are doing additional clinical study development.So we believe we'll be very well positioned to go ask for those codes yet this year. So in 2020, we'll ask CMS. They usually opine on these in the first quarter of the following year. So 2021, we should gain our coding decision at which point we then go out and get the opportunity to work on coverage policies with payers across the country, while those codes are becoming effective and they would become effective in January of 2022. So that's the cadence that we see for the head and neck product.

Ryan Zimmerman

Analyst · BTIG. Please state your question.

Thank you, Jerry.

Operator

Operator

Our next question comes from Matt O'Brien with Piper Jaffray. Please state your question.

Matthew O'Brien

Analyst

Thanks so much for taking the questions. Just to follow-up a little bit, a few questions asked earlier. Jerry, should we expect head and neck or the new expanded indication target market that you talked about today to impact the business first? And what kind of timing are you thinking? Do you think in head and neck next year and then the expanded patient population maybe more like 2022?

Gerald Mattys

Management

So I think we will see continuing growth out of the head and neck product through this year and through 2021. But I think what Ryan was getting at is when is the inflection point, and we see that as 2022, Matt.So I think once we have coding in place, coverage in place, that's when clinician adoption should really accelerate. And this is a large unserved market opportunity because these patients with head and neck lymphedema really don't have any other options to treat this condition. So we think we're in a great place. We just want to make sure we get the evidence behind us before we push down too far on the accelerator.

Matthew O'Brien

Analyst

Okay. And then the new indication would probably be sometime after that. Is that fair?

Brent Moen

Management

New indication for what, Matt? Just clarify.

Matthew O'Brien

Analyst

Extra 15 million patients that you're citing today?

Gerald Mattys

Management

Yes. So that actually is a current indication for the product. Our product is already cleared to market to treat chronic venous insufficiency and specifically with – especially with those patients that have venous ulcers. So we don't have to seek additional clearance to be able to serve that market.

Matthew O'Brien

Analyst

Yes. I'm sorry. I don't think I spoke appropriately here. I'm flipping between calls a little bit. So this script you talked about was, I think you have clinical data that's associated with it and I think it's a new opportunity to kind of go after newer patients that expands your technique. Is the thought that you are going to go after that group sometime – is it now, is it 2021, 2022? How do we think about that? How meaningful?

Gerald Mattys

Management

Yes. We think it's really meaningful and it's one of the reasons that we're more bullish on our 2020 guidance than we've been historically. We are calling on the vascular community today. And they are the ones who see the CVI-induced lymphedema or Phlebolymphedema. So we expect this will drive sales yet in 2020 and why we're so bullish on our performance this year.

Matthew O'Brien

Analyst

Got it. That's helpful. And then as a follow-up here. If I look back to 2018 and I think a lot of people are really worried – thinking about the productivity per rep, which Jerry, you're kind of talking about here. But 2018, you increased productivity per rep about $65,000 per rep. You need to do about the same thing this year that $65,000 per rep to get to your guidance.So is it bilateral that's going to lead the charge there? Is it this CVI group? A combination? How do we just get really comfortable that with all these new rep maybe disrupting some territories that you can drive that level of productivity from a product perspective?

Gerald Mattys

Management

Yes. I think it's a really good question. So we see probably the biggest driver of productivity being able to take the burden of some of the paperwork from our field team to an internal group. So we began that process about 18 months ago with a pilot that tried to get the internal team processing orders for Entre, and most of those go to the Medicare patient population because of Medicare’s requirement that a patient has a trial of a simple device before moving up to a Flexitouch.So we started it then. It accelerated in 2019, and it's one of our key initiatives for 2020 growth is to leverage this in-house team to process these orders and free up the product specialist so they can go sell Flexitouch. You will remember that Flexitouch has basically a 3x to 4x increase in the average selling price compared to an Entre. So the more we can free up their time to go sell that, the better served that we are.

Matthew O'Brien

Analyst

Got it. Thank you.

Operator

Operator

[Operator Instructions] Our next question comes from Jason Mills with Canaccord. Please state your question.

John Young

Analyst · Canaccord. Please state your question.

Hi. It's John Young on for Jason. Thank you for taking my question. My first is on, can you give us an update on your international initiatives, both from a commercial infrastructure standpoint as well as markets you believe are most credible for Flexitouch in the medium term? When could OUS sales be material contributor to growth in the overall business?

Gerald Mattys

Management

Yes. You bet, John. Thanks and welcome to the call. We continue to pursue our international opportunities. We do not expect a commercial contribution in 2020 though. You may remember we had our product approved for the CE Mark before Europe changed their medical device directive and we have just completed our quality system audit to that new standard.We expect to get the results from that audit back here in the next 90 to 120 days, at which point we'll react to whatever they say and we expect that by the end of the year, we'll be able to put the CE Mark on our products for sale in Europe. Europe is going to be the initial focus for us going forward. But again, end of 2020 for the ability and revenue not really likely this year at all, we expect that to begin sometime in 2021.

John Young

Analyst · Canaccord. Please state your question.

Great. Thank you. And then for my follow-up. As you go forward beyond 2020, how do you think about rep productivity in the head and neck opportunity? And potential additional resources, do you look to add to really tap into this opportunity?

Gerald Mattys

Management

Thank you, John. We are still of the belief that we can put 320 to 350 reps into the field and have them to be productive. This is a growth opportunity so we are continuing to invest heavily in sales and marketing. We do expect to leverage from some of our other areas on the P&L, but not really from the sales and marketing line, because we're really focused on growth there.We will get productivity enhancements as I mentioned to the last question. But our focus is really on expanding the sales organization and continuing to reduce the size of the territories that our reps cover, which we think makes them more productive and frankly better at their job.

John Young

Analyst · Canaccord. Please state your question.

Thank you. That's helpful.

Operator

Operator

Thank you. That does conclude our conference for today. Thank you all for your participation.