Welcome, ladies and gentlemen, to the Second Quarter of Fiscal Year 2023 Earnings Conference Call for Tactile Medical. 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 which 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 our most recent 10-Q filing 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 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. Dan Reuvers, Tactile Medical's President and Chief Executive Officer. Please go ahead, sir.

Thanks, operator, and welcome, everyone, to our second quarter earnings call. I'm joined on today's call by Elaine Birkemeyer, our Chief Financial Officer. Let me provide a quick agenda for the call. I'll start with a high-level overview of our financial results, along with a discussion of the key drivers of our sales performance in the second quarter. Then I'll share the progress we've made in recent months from an operational standpoint, focusing on some of our most notable accomplishments. Elaine will review our second quarter financial results in greater detail, as well as our latest 2023 financial guidance, which we increased in today's press release. Finally, I'll provide some concluding thoughts on our outlook and key areas of focus for the remainder of the year before we open the call for questions. Now let's begin with a review of our financial performance. I'm really pleased with our team's ability to deliver another quarter of performance that exceeded expectations, including double-digit revenue growth, operating leverage that led to improved profitability, strong cash flow generation, and enhancements to our balance sheet. In the second quarter, we achieved total revenue growth of 15% year-over-year to $68.3 million, driven by stronger-than-anticipated contributions from our lymphedema product. Looking at our performance by product line, lymphedema revenues increased 16% year-over-year to $60 million, while our airway clearance revenues increased 4% year-over-year to $8.3 million. We complemented our sales performance with strong year-over-year improvements in our operating results during the second quarter, including a $6.1 million improvement in our GAAP operating income, year-over-year reductions in our GAAP and non-GAAP net loss of $4.5 million and $4 million, respectively, and a $4.4 million improvement in our adjusted EBITDA. This strong financial performance across the board enabled us to generate $13.9 million of cash flow from operations, a quarterly record in our 7-year history as a public company. Turning to a more detailed discussion of our sales performance in the second quarter. In our lymphedema product line, our stronger-than-anticipated performance was largely a reflection of the engagement, retention, and improving productivity we saw across our sales team. From a retention perspective, we ended the second quarter with 249 field sales representatives compared to 250 at the end of the first quarter and the beginning of 2023. Our improved sales force productivity benefited from several factors, including the increasing tenure of our team, the introduction of new products, and our continued efforts to improve our operational efficiency. Most notably, in March, we began the full market release of Entre Plus, our next-generation Entre system offered for patients who qualify for a basic pneumatic compression device. Many payers require patients to begin with a basic pump prior to considering whether their condition qualifies them for an advanced system like the Flexitouch. The development and introduction of our Entre Plus system reflects our increased focus on identifying, engaging with, and supporting this important segment of lymphedema patients. In connection with the full market release of Entre Plus, our team engaged with existing and prospective prescribers to introduce the new system and its features and then worked with them to identify qualified patients who could benefit from its use. The response to Entre Plus by both prescribers and patients has been very favorable, and we've seen strong adoption and sales growth in this portion of the market during the initial months post-launch. Our Entre Plus system and the Flexitouch ComfortEase garments we launched last year feature enhancements that facilitate the bilateral treatment of lymphedema in the lower extremities, a common therapeutic area of focus for patients suffering from lymphedema related to vascular disease. With these two enhanced treatment options in our portfolio, we continue to see strong growth in sales to patients treated at vascular clinics. Additionally, the productivity of our sales team continued to benefit from our efforts to streamline medical record exchanges and reduce the administrative burden on both our reps and prescribers. In recent quarters, we've made progress in reducing the time our sales reps spend on processes that limit their market development bandwidth, including obtaining documentation and conducting in-home patient demos. We've also improved the efficiency of our interactions with prescribing clinicians with simplified forms and an enhanced process for exchanging documents. As I discussed on our earnings call in May, we introduced a more streamlined internal process for submitting claims data for patients covered under Medicare, which, along with CMS's discontinuation of its requirement for a certificate of medical necessity at the beginning of this year, has helped reduce the administrative burden for clinicians. With respect to our airway clearance product line, the modest sales growth we observed in the second quarter was the result of one large DME partner experiencing slowed AffloVest placements due to changes in eligibility criteria associated with the expiration of the COVID-19 public health emergency waiver on May 11. The return to pre-public health emergency eligibility requirements slowed their processing and placements of AffloVest. Consequently, we now expect this DME partner's volume to be lower, and we've adjusted our guidance accordingly. It is worth noting that the remainder of our DME partners continued to grow in the second quarter. Now for an update on our operational performance. In recent months, we've executed across multiple aspects of our strategy to enhance our positioning in the markets we serve. Among our accomplishments, we have advanced our product portfolio with multiple patient-centric innovations, educated patients and clinicians, enriched our senior leadership team with key talent, and increased our available borrowing capacity to support future growth initiatives and enhance the company's financial flexibility. With this backdrop, I'll detail a few of these items, starting with an update on our new product initiatives. We've been very pleased with the reception our Entre Plus system has received since its full market release in March. Entre Plus is the first generational update to our Entre system in 8 years. It includes a variety of enhancements aimed at improving the overall patient experience while delivering the same therapeutic benefits. Among its enhancements, Entre Plus features an LCD-based user interface that provides patients with easier access to information about their treatment sessions. It also features active garment deflation, allowing patients to easily remove and store the system after their treatment. For patients requiring bilateral treatment, the system's controller allows simultaneous treatment of both limbs, which is crucial for efficient therapy. Importantly, for those patients who may need a more advanced pneumatic compression device later, our Entre Plus was designed to ensure consistency across our product family, making the transition to Flexitouch more seamless if necessary. Feedback during the initial months post-launch, along with our strong lymphedema sales performance in the second quarter, indicates that these key features and enhancements resonate with customers. During the second quarter, we also expanded the capabilities of our Kylee mobile application. The latest version includes enhanced features that enable patients to easily record, track, and compare changes in their skin condition, limb measurements, and other lymphedema-related symptoms. We believe these improvements boost Kylee's utility as a resource for patients to monitor their disease progression and treatment progress, allowing them to share this information with their physicians. Kylee now features improved treatment reminders, helping patients establish a consistent self-treatment routine. The new enhancements and their benefits are recognized and appreciated by the clinicians we serve. We experienced compelling adoption and utilization trends in the second quarter, with strong sequential growth in the number of Kylee downloads and user check-ins. Approximately 500 unique customers downloaded Kylee in the second quarter, a 37% increase over the first quarter, while the number of patient check-ins reached nearly 63,000. Overall, we've been very pleased with Kylee's progress since its launch, and we look forward to enhancing its utility as a crucial resource for educating, diagnosing, training, and effectively treating lymphedema. Additionally, we completed the prelaunch stages for our ComfortEase upper extremity garments during the second quarter and began our full market release in July. Like our lower extremity ComfortEase garments launched last summer, the design of these upper extremity garments drew from our experience in developing athletic apparel, with the main goal of improving the treatment experience for our patients. Our ComfortEase garments are lighter, cooler, and more malleable than previous offerings and were designed with input from patients and therapists for ease of use in daily treatment. Our new chest garments provide enhanced therapy to the axillary region, vital for optimal therapy among breast cancer survivors. Our progress this past quarter illustrates our commitment to a steady flow of new product innovations focused on addressing the lifestyle needs of our patients, improving digital functionality, and optimizing treatment processes. Regarding our efforts to raise awareness and educate the market on the underserved conditions we address, we hosted 41 clinician-focused education programs during the second quarter, which attracted around 1,200 attendees. These events covered a variety of important subjects, including foundational programs on the causes, diagnosis, and treatment of lymphedema, along with specific topics like lymphedema related to breast cancer and lipedema. Many programs enabled participants to earn continuing education credits. For our airway clearance product line, we sponsored an article in the June edition of RT Magazine, focused on respiratory care. The article summarized results from a blinded, randomized patient preference study comparing four high-frequency chest wall oscillation devices, including our AffloVest. Conducted by an independent market research firm, the study involved 30 symptomatic adults naive to vest therapy, each of whom trialed all four devices at equivalent settings. Participants assessed their preferences across several categories, with 93% favoring AffloVest over other devices and expressing willingness to comply with therapy if it was prescribed. Additionally, the study found that 77% preferred AffloVest's controls and features, while 90% appreciated the experience of removing AffloVest compared to others. This study supports the conclusion that AffloVest's features likely enhance patient compliance and provides our DME representatives with valuable evidence for discussions with prescribers and patients. Although our growth primarily comes from an expanding pool of eligible patients, we believe this paper can aid our DME channels in competing for market share. Lastly, we've strengthened our senior leadership team. In June, Dr. Tony Gasperis was appointed as our Chief Medical Officer following the retirement of Dr. Thomas O'Donnell. Dr. Gasperis has served as Chair of our Scientific Advisory Board since 2020, is a Professor of Surgery and Director of the Center for Vein Care at Stony Brook University, and is a past President of the American Venous Forum. He's an experienced healthcare leader dedicated to innovative care and raising awareness of lymphedema. In July, we appointed Sherri Ferstler as our Senior Vice President of Sales, succeeding Eric Pauls. Sherri joins us from Johnson & Johnson Vision, where she led a sales team of 325 as VP for North America. Throughout her 25-year healthcare career, Sherri has led national and regional sales teams at Bayer Diabetes Care, Endo Pharmaceuticals, and Mylan Pharmaceuticals, achieving growth in revenue and profitability. We're excited to welcome Sherri to Tactile Medical, adding depth to our talented team.

Thanks, Dan. Turning to review our financial results. Unless noted otherwise, all references to second quarter financial results are on a GAAP and year-over-year basis. Total revenue in the second quarter increased $8.7 million or 14.6% to $68.3 million. By product line, sales and rentals of lymphedema products, which includes our Flexitouch and Entre systems, increased $8.4 million or 16.2% to $60 million, and sales of our airway clearance products, which includes our AffloVest system, increased $329,000 or 4.1% to $8.3 million. Continuing down the P&L. Gross margin was 70.7% of revenue compared to 72.5%. Non-GAAP gross margin, which excludes noncash intangible amortization in both periods, was 71.1% compared to 73%. GAAP and non-GAAP gross margins in the second quarter of 2023 were impacted by higher labor rates and material costs as well as higher costs related to new product launches and changes in our mix related to strong growth in sales of our Entre Plus system. Second quarter operating expenses decreased $1.1 million or 2.3% to $46.2 million. The decrease in GAAP operating expenses was driven primarily by a $600,000 decrease in sales and marketing expenses and a $500,000 decrease in noncash intangible asset amortization and earnout expense. Operating income was $2.1 million compared to an operating loss of $4.1 million. The $6.1 million improvement in our operating income was driven by a $5.1 million or 12% increase in our gross profit as well as the aforementioned $1.1 million or 2% decrease in our operating expenses. Non-GAAP operating income was $3.6 million compared to an operating loss of $1.8 million. As a reminder, our non-GAAP operating income excludes noncash intangible amortization and earnout expenses as well as certain nonrecurring operating expenses in the prior year period. We've provided a detailed GAAP to non-GAAP reconciliation in our earnings press release. Other expense net was $800,000 compared to $600,000 last year, primarily due to an increase in interest expense, driven by a higher average interest rate on outstanding borrowings compared to the prior year period. Income tax expense was $1.3 million compared to a benefit of $20,000 in the second quarter of 2022. Net loss declined by $4.5 million year-over-year to $100,000 or $0.00 per diluted share. Non-GAAP net income increased $4 million to $1 million compared to a non-GAAP net loss of $2.9 million last year. Adjusted EBITDA increased $4.4 million to $6.1 million or 8.9% of sales compared to $1.7 million or 2.8% of sales last year. Turning to the balance sheet. As of quarter end, we had $63.2 million in cash and $47.5 million of outstanding borrowings. This compares to $21.9 million in cash and $49 million of outstanding borrowings as of December 31, 2022. The increase in cash was driven by the reduction in net loss and improvements in working capital efficiency compared to the prior year quarter and prior periods. Specifically, working capital was a source of nearly $10 million of cash in the second quarter of 2023 compared to $1.5 million last year and a use of $2.9 million in the prior quarter. This significant improvement in working capital efficiency to date has been driven primarily by better days sales outstanding performance which has resulted in strong cash flow from operations. The $13.9 million of cash flow from operations we generated in Q2 is a quarterly record for the company, which is not only impressive but also underscores our confidence in our ability to deliver a cumulative free cash flow target of more than $75 million for the 3 fiscal years ending 2025. We made additional strides to further strengthen our balance sheet, adding to our financial flexibility we entered into an agreement to amend our existing credit agreement that extends the maturity of our term loan and the revolving credit from September 8, 2024 to August 1, 2026. It also expands our available borrowing capacity to $55 million, which is an increase of $8.25 million. And lastly, our amendment agreement includes more favorable borrowing terms, including lower rates and less restrictive covenants. Shifting to a review of our 2023 outlook which we updated in today's press release. We now expect full-year 2023 total revenue of approximately $274 million to $278 million, representing year-over-year growth of 11% to 13% compared to our prior guidance of 10% to 11.5%. Our total 2023 revenue guidance range now assumes sales and rentals of our lymphedema products increase approximately 13% to 14% compared to our prior guidance of 9% to 10%, and sales of our airway clearance products increase approximately 0% to 5% versus our prior guidance range of 18% to 21%. These updated growth assumptions reflect better-than-expected sales of our lymphedema products in the second quarter and higher growth expectations in the second half of 2023. It also assumes updated expectations for airway clearance products in 2023. For modeling purposes, for the full year 2023, we expect our GAAP gross margins to be approximately 71%, our GAAP operating expenses to be flat to down 1% year-over-year compared to our prior expectation of low single-digit increase year-over-year, interest expense of approximately $3.8 million, a GAAP tax rate of 57% compared to our prior guidance of 61%, and a fully diluted weighted average share count of approximately 23.5 million shares. Based on the stronger-than-expected profitability performance in Q2 and our updated expectations for the second half of 2023, we now expect to generate adjusted EBITDA of approximately $25 million to $27 million in 2023 versus our prior guidance range of approximately $23.5 million to $25.5 million. Our adjusted EBITDA expectation assumes certain non-cash items, including stock compensation expense of approximately $9.8 million compared to $11 million previously, intangible amortization, and changes in fair value of contingent consideration of approximately $5.8 million and depreciation expense of approximately $2.5 million, both of which are unchanged versus prior guidance assumptions. With that, I'll turn the call back to Dan for closing remarks.

Thanks, Elaine. With another quarter of strong financial and operational performance under our belt as well as a recently enhanced balance sheet, we believe we're incrementally better positioned to pursue our growth and value creation objectives going forward. In the second half of this year, we remain committed to delivering further execution regarding our four strategic priorities which, as a reminder, are as follows: improving the productivity of our lymphedema field sales team, expanding airway clearance therapy through our DME providers, introducing new products and innovations focused on addressing the lifestyle needs of our patients, and improving digital functionality and therapy optimization; and finally, enhancing our operational efficiency to continue to reduce our overall cost to serve while staying focused on patient satisfaction. We're pleased to have been able to impact so many patient lives as we demonstrate improving profitability, strong cash flow generation, and an enhanced balance sheet in addition to our return to double-digit top-line growth. We look forward to continuing our recent momentum towards achieving our stated longer-term, strategic and financial goals in 2023 and in the coming years. I'd like to close by thanking our team members for their impressive contributions to our development and growth as an organization this past quarter, thanks to our customers, suppliers, and shareholders as well for their continued support. And with that, operator, we'll now open the line for questions.

Our first question will come from Adam Maeder with Piper Sandler.

This is Simran on for Adam. I want to start off with one on the sales force and specifically the transition at the SBP rule. Just any details or color that you can provide on that transition? Is there a change to the company's strategy regarding sales force? And what disruption, if any, could this signal for the sales force looking ahead?

Yes. Good question. First of all, this is not an indicator of any change in strategy. This is just a change in people that are basically running our play. Eric did a nice job for us, of course. But he and I had a good open dialogue about a transition that was in store. And I think that it led to a really good, smooth succession transition. We had the luxury of having some good communication to ensure a competitive search and I was really, really pleased to be able to land the kind of talent that I think Sherri is going to bring to the company. She's brought VP level experience and has more than 2 decades of senior-level leadership. Interestingly, she had an associate rep model that looked quite a bit like ours, bringing in young salespeople and focusing on people development. She was able to demonstrate some of the best retention results at J&J. So I think all of those certainly position her nicely. I think the other point I would just make is that we are really lucky to have a very strong next-level leadership team. Our four area directors on the lymphedema side have all been with us for a number of years, and three of the four have been with us for over 8 years each with the company. I think they have 30 years collectively among the four of them with us. So I think that if you're a salesperson, your regional manager is still the same person, your area director one notch up is still the same person. And our strategy remains unchanged. So I feel like we're going to be able to navigate these changes quite smoothly.

Okay, perfect. I appreciate it. And just for my follow-up, on AffloVest, I guess, we were pretty surprised to see it was down sequentially as well. Maybe walk us through the impact of the eligibility criteria changing and why it was isolated to only that one DME supplier. And then, I guess, the updated guidance implies a pretty significant deceleration in the second half. So maybe any additional puts and takes for the second half of the year.

Sure. I think the first point to make is that when you're going through a DME and not your own direct sales force, things can get a little bit lumpier. We did have one large DME that had really adopted the PHE criteria and implemented it more so than the balance of the field. And when I say PHE, just to be clear, public health emergency. So when COVID was established, there was about a three-year period where CMS said they were going to relax some of the criteria. And for this specific category, it was affected. One of the most specific ones is that you didn't need a CT scan to submit or get approved for this. That expired in early May after three years of being in place. And this DME, I think, had taken advantage of that relaxed criteria a bit more. So they're pivoting back to the original criteria. I think we expect to see a little bit of slowed placements with them as a result. The important balance is that we have seen growth from all of the other top DME partners and we expect that to continue through the balance of the year as well.

Next question comes from the line of Margaret Kaczor with William Blair.

I wanted to start out with lymphedema, obviously doing quite well, nice meaningful increase in guidance. How much of that is on Entre Plus, I guess? And what is implied of Entre Plus not only this quarter, Q2 but also going forward? The real question, I guess, behind all of this is any details over percentage of Flexitouch accounts that tried or purchased Entre Plus and your sense of market share on the back end of that launch and has it increased?

Margaret, it's Elaine. I'll start and I'll ask Dan to fill in here. So for the quarter, we saw growth in both our basic and advanced pumps, the Entre and Flexitouch. We did see faster Entre growth. We walked into this quarter with the new product, focusing across both products. The basic pump category is important for us. Many payers require a basic pump trial first before moving to a more advanced pump if the patient's condition warrants it. So it's an important area for us to be in. We saw the favorable reception of our Entre Plus product drive that strength as well as just a balanced focus across our entire portfolio. We expect to see those trends as we move into the back half of the year. I think the strength in both of those products helped lead us to raise our guidance for the lymphedema product for the full year, too.

Yes. And I would just add too, Margaret, that I think to your question about share, we don't have specifics but I think that given the strength we've seen in our Entre Plus, we certainly would expect that we've picked up a bit of share here recently. I think it also positions us well with our patient base. So those that become eligible for Flexitouch, we've established that relationship and we've started to provide the basic therapy available to them. Hopefully, with the continued expansion of Kylee, we can maintain that relationship with those patients through their journey.

Okay. I appreciate that. And then on the AffloVest side, I'll maybe push a little bit more specifically on that. It seems like second half growth for AffloVest may be in the low single digits despite having an easier comp in the fourth quarter of '22. So I'm just curious, how do you look at recovery within that business? And as you look at growth drivers, are you just not penetrating a lot of the HME accounts so you could go deeper that way where you're broadening out your breadth? Or do you expect this one DME to come back eventually with good growth?

Yes. I think that we certainly expect this one to come back. They've sort of reestablished a new baseline. That's the headwind that we'll be overcoming. We have continued to grow, as I said, in all of the others in the top 10 and expect to continue to do that. But there's a little bit of a give and take there. I think to your question about what are we doing to continue to invest in the growth, first of all, the study, I think, is an important one. As I've said many times, I think most of our understanding of the units that have been placed by our DME partners have largely been organic growth with patients who would have otherwise probably not been introduced to a vest but were eligible. I think the study gives us an opportunity not to be so binary. There's no reason that we can't compete for share at the same time. So that's a new tool that we're equipping these sales reps with as we speak. It's a big universe as we've talked about also with sales reps across the DME community. It's one of the reasons that we like the channel because the army is so big. But it also indicates that we probably could use even more coverage. So we're going to add a few more people. We've got 12 or 13 salespeople. We're going to add a few more to make sure that we're providing the kind of coverage that we think the market deserves.

Next question comes from the line of Suraj Kalia with Oppenheimer.

Dan, can you hear me all right?

Hear you fine, Suraj.

Guys, my apologies for the background noise. So Dan, may I quickly ask my two questions? First, you talked about the number of reps looking to add a few. Perhaps you could give us a baseline in terms of how to think about utilization metrics per site, accounts per rep, revenues per rep, how should we think about those? And also specifically, Dan, have there been any changes in sales rep commission structures, just to incentivize one way or the other? I'll hop here and pardon the background noise again.

Sure. Thanks for the question, Suraj. Short answer on the commissions is no. I think that we've got the right incentives in place aimed at ensuring we continue to expand awareness within our communities and help more patients. But from a productivity metric standpoint, I think that we'll continue to evaluate what are the right tools as we get a new leader in place that she's going to want to see. Overall, the best metric to use is if you look at roughly what our headcount is, it's been flat, and we've been delivering double-digit growth for the last couple of quarters. So that's probably the best reflection of expanding productivity. We've continued to liberate our salespeople from some of the in-home demos. We've got some of our patient trainers well-equipped to educate and introduce the devices. If we can deploy them more resourcefully where it makes sense, it gives the sales rep more time for market development and education of the HCP community. I think we're seeing some progress there. But with sales expenses down year-over-year, headcount relatively flat, and lymphedema sales up 16%, those are probably the best macro metrics; at a more granular level, our field sales managers pay attention to target accounts and new accounts.

Next question comes from the line of Ryan Zimmerman with BTIG.

This is actually Izzy on for Ryan. First off, I was just wondering if you could provide any updates on your ongoing head and neck trial. When could we expect to see some top-line data from the trial? And roughly how large of an opportunity does this represent?

Sure. Thanks for the question, Izzi. The head and neck RCT is advancing. This is the one, for those that are less familiar, where we're committed to tracking probably 200-plus patients against the standard of care. We expect to have over 180 patients enrolled by the end of this year. We hope to complete the enrollment by early 2024, and the follow-up is a handful of months. So probably in 2025, we expect to get the results published and the kind of impact that we hope it will have on payers. This will be, by far, the largest RCT done, we believe, in this space and certainly, by any measures in this head and neck community of cancer survivors. We've said that around 10% of cancer survivors would be head and neck. So that frames a bit of that. We certainly think it can be a meaningful contributor to us as we approach late 2025. One consideration we made is that we thought about what our 2025 revenue targets would be when we established those last fall.

Great. And just one follow-up. I heard your comments on the engagement of the Kylee app and it sounds encouraging. But what is the tangible benefit that you guys are seeing in sales given the engagement level?

Well, I think that it's still emerging. One of the things that we believe is that continuing to communicate with these patients will help us identify how well they're doing and if and when they'll need to graduate to another device. Their ability to record their sessions, measurements, and even capture photos, we think, is going to make it much more compelling when they become eligible for an advanced pump. I think the other piece that we still expect to benefit from is some of the order management processes we want to expand our Kylee application. Our ability to engage with patients more like we would with your favorite airline app where you can place your order, change your order, check your status. I believe that could help reduce the cost to serve, while concurrently allowing us to improve engagement with patients in whatever timeline and format they prefer. So there's a component of operational exchange that is still ahead. But in the meantime, we think that the ability to continue to educate patients is an excellent way to expand the universe of patients that can receive a diagnosis and ultimately treatment.

We are currently seeing no remaining questions at this time. That does conclude our conference for today. Thank you for your participation.

Thank you, everyone.