Good afternoon, ladies and gentlemen, and welcome to the TELA Bio Third Quarter 2021 Earnings Conference Call. [Operator Instructions]. As a reminder, this conference is being recorded. I would now like to turn the conference over to Hannah Jeffrey from the Gilmartin Group..

Thank you, Suzanne, and good afternoon, everyone. Earlier today, TELA Bio released Financial Results for the Third Quarter 2021. A copy of the press release is available on the company's website. Joining me on today's call are Tony Koblish, President and Chief Executive Officer; and Roberto Cuca, Chief Operating Officer and Chief Financial Officer.

Before we begin, I'd like to remind you that during this conference call, the company will make projections and forward-looking statements regarding future events.

We encourage you to review the company's past and future filings with the SEC, including, without limitation, the company's 2020 Form 10-K and subsequent Form 10-Q, which identify the specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.

These factors may include, without limitation, statements regarding product development, product potential, regulatory environment, sales and marketing strategies, capital resources or operating performance. With that, I'll now turn the call over to Tony..

a study titled robotic assist ReBAR of 111 inguinal hernias presented by Dr. Cory Banaschak and Dr. Paul Szotek.

The authors concluded that robotic transabdominal peritoneal inguinal hernia repair with OviTex represents a viable and more natural repair alternative in minimally invasive surgery and approach typically reserve for permanent synthetic meshes.

Another study from the same authors was recently published in the Journal of Clinical and Medical Research, this prospective study of 619 implants using the ReBAR technique for a variety of open and minimally invasive inguinal and abdominal hernia repairs reported an overall recurrence rate of just 1.3%. And also at SAGE, Dr.

George DeNoto, the Director of General Surgery at St. Francis Hospital in New York published, use of ovine reinforced tissue matrix in bridge incisional hernia repair, in which he analyzed recurrence rates in the treatment of abdominal hernias that require reinforcement in the absence of a primary repair.

This is the most complicated hernia repair, abdominal wall reconstruction possible. In this series, patients with bridge repairs using OviTex had a 14% recurrence rate, which is approximately half of the recurrence rate typically seen when repaired with porcine mesh products in a similar patient population.

Over the past few quarters, we have produced and captured valuable clinical data that we believe demonstrates the benefits of natural mesh solutions, which brings me to the next step of the process, physician education. In efforts to continue educating surgeons, we have succeeded by employing virtual sales and marketing programs.

These programs have allowed us to reach both new and current surgeons regardless of the market slowdown. These initiatives, including TELA LIVE, will remain a priority as we continue using them to educate surgeons about our product portfolio and clinical data.

We held over 20 events during the third quarter, engaged over 250 surgeons, including events held in areas experienced delta-related micro surges. Each touch point with a surgeon to the medical education events opens the potential for the use of OviTex in more applications and an opportunity for new business.

We have seen an excellent correlation between educating surgeons about our products and surgeon adoption. Combining our virtual sales and marketing initiatives and increased clinical data efforts have been vital as we invest in brand strength.

Brand strength is the foundation needed to grow sales and serves as the basis of our second initiative, commercial execution. Armed with multiple sales avenues and robust supporting data, commercial execution means scaling our direct sales force, driving account manager productivity and securing additional utilization and contracts.

We continue to sign new accounts while growing our existing accounts, building a cohesive sales funnel. We now have 40 sales reps producing in 45 sales territories, promoting geographic diversity and enabling the business to withstand localized COVID-19 hotspots that limit surgeries in those areas.

Currently, although our sales team is not at capacity, our sales reps are generally exceeding expectations. We continue to build our sales team to our desired goal and expect these additions to accelerate our top line growth further. To further our strategic initiatives, we recently entered into a distribution agreement with Next Science.

This agreement gives us exclusive rights to sell and market next Sciences, proprietary antimicrobial surgical wash with XBIO technology across the U.S. plastic reconstructive market. We also have the first right of negotiation for the EU market upon successful CE approval.

Next Science's proprietary biotechnology controls, potential surgical infection by addressing the biofilms that make bacteria more resistant to traditional antimicrobial agents, disinfectants and most immune defenses. Also, its no-rinse delivery allows it to provide over 5 hours of ongoing protection against bacterial biofilms.

We are thrilled to offer this novel infection-control solution to customers in the United States, combining our best-in-class OviTex PRS portfolio of reinforced tissue matrix with Next Science's advanced anti-biofilm surgical wash, not only diversifies our supplier base, but also transitions our company to one that offers an innovative soft tissue reconstruction and preservation portfolio.

In addition to our strategic initiatives in September, we announced the appointment of Roberto Cuca as the company's new Chief Operating Officer and Chief Financial Officer. As COO and CFO, Roberto will lead the execution of the company's business plan and manage the company's finances.

Roberto joins the TELA team with over 25 years of experience in relevant operational and finance positions within the healthcare industry. Although he has only been with TELA just over a month, Roberto is already contributing to the company, has quickly become an integral part of the team.

With that, I will now turn the call over to Roberto to discuss our financials..

Thanks, Tony. After commenting on our third quarter financial results, I'll review our financial guidance for the full year 2021.

As Tony mentioned, revenue for the third quarter of 2021 increased 44% year-over-year to $7.7 million due to the continued performance of our commercial organization, increased penetration within existing customer accounts and stronger-than-anticipated international sales. Our third quarter revenue grew slightly on a sequential basis.

Gross margin was 60% for the third quarter, a decrease of approximately 170 basis points compared to the third quarter of 2020. The decrease was primarily due to an increase in the reserve for excess and obsolete inventory as a percentage of revenue as a result of growth in the company's product inventory over the course of the third quarter.

Sales and marketing expenses were $6.9 million in the third quarter of 2021 compared to $6.3 million in the same period in 2020. This increase was mainly due to higher travel and consulting expenses. G&A expenses were $3.5 million in the third quarter of 2021 compared to $2.6 million in the same period in 2020.

This increase was mainly due to greater professional consulting and legal expenses, increased insurance expense and higher recruiting fees. R&D expenses were $1.4 million in the third quarter of 2021 compared to $1.2 million in the same period in 2020. This increase was primarily due to increased testing and development expenses.

Loss from operations was $7.2 million in the third quarter of 2021 compared to $6.9 million in the prior year period. Net loss was $8.3 million in the third quarter of 2021 compared to $7.7 million in the same period in 2020. We ended the third quarter of 2021 with $53.6 million in cash and cash equivalents. Now turning to the outlook for 2021.

We are maintaining our guidance for revenues to be in the range of $28 million to $30 million, representing growth of 54% to 65% over the prior year period. This reflects our most recent assessment of the current environment and continuing uncertainty relating to the evolving impact of the COVID-19 pandemic.

With that, Suzanne, please open up the call for questions..

[Operator Instructions]. Our first question comes from the line of Matt O'Brien from Piper Sandler..

This is Drew on for Matt. And congrats on a nice quarter and congrats Robert on the new role as well. I wanted to start off a little bit on PRS because that was really the area of the business that stood out to me. It looks like it grew sequentially despite what was a more difficult environment.

So maybe you could just talk to kind of what you're seeing there from an account penetration perspective? And just any thoughts on how quickly it can ramp in a less COVID-impacted environment that we're transitioning to?.

Yes, it's interesting. We did a lot of work last quarter meeting with plastic surgeons for various planning activities. And I think some of the surgeons had indicated they definitely saw an impact due to COVID with cases being delayed or pushed out, and others really saw no impact. So I was a little interested in that.

I thought these would be a little bit more immune, but I do think there was a bit of an impact. So PRS right now for us is still in that early phase of the release where we're finding the heavy users. They're evaluating how the product is working and then they continue forward.

So it's still a little bit up and down in terms of starting, wait, assess and then continue. But for the most part, we're progressing quite well with PRS. And we're figuring out what our value proposition is slowly but surely. And we're figuring out the algorithm of how and when to use the different versions of our product.

One of the things that's working quite well for us is to have different products within the portfolio that can serve different needs, different technique preferences, different patient needs, different degrees of difficulty. And I think that process is going to yield a tremendous product portfolio.

But right now, we are still in the process of working through and figuring out where each piece of the puzzle fits. But yes, I mean, so far, it's looking good. And I think it's going to continue to be an important piece of our business. We're probably running about 85%, 15% in terms of ratio on units and maybe more like 80%, 20% or so in dollars.

So definitely keep an eye out for PRS. It's coming along nicely. We're pleased..

Okay. Perfect. And good to hear. And then on the core hernia side, if my numbers are correct, and please correct me if they're not, but it looks like it was down a little bit sequentially compared to last quarter. I assume that's largely related to COVID. And I know you provided some helpful commentary in the marketplace in the past.

So maybe just an update on recent trends. Anything you can say on October would be helpful as well..

Sure, Drew. And just before Tony steps in to give some color on the market. Just to clarify. So OviTex was up sequentially from the second quarter and PRS was actually down slightly sequentially from the second quarter. So Tony, if you want to touch on....

Yes. Yes. So there's a -- hernia is our foundation, and we're getting used more and more broadly for sure. We're up to about 60% estimate of hernia units being done either robotically or minimally invasively, which is up from 50%, 52% last couple of quarters. So the hernia business is really feeling strong. It's bolstered by that clinical data.

I think we were chugging along quite well with both hernia and PRS through up to September. Most of -- certainly, we were losing some cases here and there in the first 2 months of the quarter. But really, for us, it was a concentration of effect in September.

And to give you a little bit of color of that, we usually do about 40% of our revenue in the last month of a quarter, which is really probably centered mostly around incentive compensation being quarterly based and PO collection schedules, et cetera. We only did about 30% of the quarter's revenue in September.

So we were rocking and rolling and then we fell into a bit of a hole in September. And then I would say October was improved from September, but I'm going to classify it as sort of a taper climbing out of the September hole, we're tapering up and now I'm quite happy where we are again. So it's interesting.

We've had a more concentrated effect here that hopefully remains to be short-lived..

Okay. Perfect. That's very helpful. Thanks for the correction there. And then just last one for me on the rep side of things. I think you mentioned about 40 reps. If I remember correctly, you had been targeting around that 50 number by the year-end. So that if I got the numbers correctly there, I mean that seems like a sizable step up here in Q4.

So maybe you could just help us understand how that's trending relative to what you guys were discussing last quarter and just how the productivity metrics are trending as well, would be great?.

Yes. I mean we -- our rep productivity is really looking good. The improvements are stark. We have 2/3 of our sales force is either at $1 million or higher or on track to get to $1 million, I'd say, in that $500,000 to $750,000 range.

And then the last 1/3 has been on board for less than a year, but even their productivity is starting to come up the curve quite nicely. So we've never been stronger in terms of depth and penetration into accounts and rep productivity is looking quite good. Now part of that program has been to prune the low performers.

We have really exacting metrics that we're measuring now that our Chief Commercial Officer is put in place and the whole commercial team really has put in place for the last 12 months or so and it really allows us to be prescriptive on here's what -- here are the activities that we know will work based on history.

And if you're not doing them, then maybe this isn't the right place for you. So I classify and say that as we implemented this rigorous process, we were down a bit on the rep count, and now we're starting to build up.

We're hiring a little more slowly interviewing more thoroughly, more thoughtfully, and we're using the algorithm and process as a guidepost to make sure that we get reps in the future that can follow this tried and true proven recipe for success.

So I would expect our rep hiring to start to tick up at a better pace or a higher pace, I would say, not better, not worse, but a higher pace by the end of this year, early next year. And I think we may be a little short of that 50 goal by the end of the year, but we should make up for it in the first half of next year.

But the good news is we're doing more with less..

Our next question comes from the line of Anthony Petrone from Jefferies..

This is Frank Pinal on for Anthony. Just 2 quick ones, I guess. First one, on robotics, I'm just wondering if you can sort of trace out how the penetration works out over the next year or 2 just sort of looking at da Vinci robotics procedures. I think they crossed the 250k mark last year.

Just wondering how you're thinking about that from a TAM/penetration standpoint? And then just as a follow-up question, just wondering what you're seeing in terms of hospital access and staffing impacts? And how long you think that, that could persist?.

Yes. So on the robotics front, I've said this before, and I guess I'll say it again, a robot is going to eat hernia maybe all accept the most complicated Ab Wall reconstructions or special circumstance cases. So if you just look at the inguinal market at 750,000 to 1 million procedures roughly, the robot is 25% penetrated.

So our strategy, our goal and what we're accomplishing is to be in lockstep with the robot through maniacal focus on compatibility, right? So the LPR product line center a little more reinforcement, a little more polymer, works extremely well with the robot. And that's really what I would consider to be a second-generation version of our product.

Our entire product portfolio is robot-compatible, but LPR is more robot-compatible. We're working on a next-generation product in the next couple of years. We'll have a third-generation product that's even more robot compatible. So we're going to go lockstep with the robot or robots. And as they scale, we scale.

So this has been a very conscious, deliberate choice from the beginning, and it's working. We spent 2 quarters hovering at about 50%, 52% and now we're at 60% or roughly thereabouts. And I expect us to just continue to invest in the ReBAR technique which is enabled by our technology and our products and robot compatibility is a key feature of that.

In terms of the COVID situation, I feel like if this is the third impact point that we've seen since it all started, the character here is different than previously, right? I think previously, it was protect the hospitals and ICUs or the ICU fills up and then depletes, fills up and then depletes. This time, it feels a little bit different.

It feels more like after shock where we're seeing nursing/labor shortages or just supply chain issues. I think these elements are harder to predict when they're going to come and go. I think they're going to continue to be patchy.

They may persist longer but the impact is different, right? Our reps can still get into the OR, they can do the selling activities and servicing activities. That is much improved. It's just case volume, I think that's going to be the factor.

And there are some things that we can do to make ourselves grow through that just like our plan initially was to grow through the first phase of the pandemic through the TELA LIVE. So certainly, TELA LIVE is going to be a big piece of that program going forward.

The next piece is investment in inventory, right? We've got to have enough inventory so that in case there are supply chain issues for little commodities that we're ahead of the game, and we've done that. We're in good shape on inventory.

The next thing is increased the consignment volumes, right? COVID always favors the incumbent, and as a new player, we're not the incumbent. So if we can get on the shelf through consignment, then we're in good shape.

And then the last phase is more reps and account managers in diversified territories, which means that we can survive any micro areas that go up or down for whatever reason, and continue to grow through all of this.

And for reference, we've doubled the size of our business since COVID started, and we really started commercializing right before COVID started. So I think we've got a formula here that's well thought out.

There's a little acronym here that I was just playing with L-I-V-N, LIVN, TELA LIVE, inventory consignment and new reps, right? So that's, that's kind of what we're thinking. And I think we've proven the model out because of the rep productivity is there. So now is the time to go..

Our next question comes from the line of Kyle Rose from Canaccord..

So I just wanted to see if we could get a little more color on the Next Sciences partnership here and maybe what we should expect from a medium term with respect to the business model? And then just longer term, from a product development perspective, I know you guys have been pretty prolific from your R&D perspective as far as you're bringing new products to the market, maybe what can we expect over the course of the next 12 to 18 months?.

Thanks for that question, Kyle. I'm going to frame it as a 24-month time horizon basically, because we have some stuff that's shorter term, but most of it is a little out there.

So what we're doing is we're suddenly repositioning our company to be -- to have a bigger play in soft tissue, right? So soft tissue reinforcement and reconstruction or soft tissue reconnection is what we have been traditionally with all of the products in our OviTex range.

We're now thinking about a bigger opportunity around the concept of soft tissue reconstitution and ....

Maintenance..

Maintenance support, yes. So there's 2 sort of subcomponents there. One is reinforcement, which is our current product line and the other is what we're calling soft tissue management.

And the Next Science product is a great example of soft tissue management, things like anti-infection or antimicrobial, dead space management, fluid management, stuff like that, right? There's a whole range of technologies that we can take a look at that if we invest in, we'll make the reinforcement products work very well and create almost a whole solution around the soft tissue reconstitution.

So that's where we're focused. So you're going to see a range of new reinforcement products that roll out in that time horizon. And you're going to see, hopefully, a range of different types of soft tissue management products that roll out in that time horizon.

Our goal is to be the expert in how to make the soft tissues heal and become reconstructed in a better way. And I think that we've hit on a bundled sort of solution that is the direction that we're going to be taking the company from a strategic perspective. We'll have more to say about it as things get closer.

But for now, we're pretty darn pleased with the Next Science deal. We really like the concept of an anti-biofilm technology and we're going to do a phased release.

The first phase will start, hopefully, very soon, and we should start generating revenue once we test out the alpha launch and make sure we understand the nuances of how to position the product and how to price the product and all that good stuff.

We should start to see revenue maybe in the second or third quarter of next year, but we'll be doing plenty of cases to learn between now and then, and we'll keep you posted as we learn..

Great. And then maybe just could you give us an update -- you may have given it, but I missed it, was just your core accounts.

And I think you talked on sales rep productivity, but maybe core accounts and maybe where you stand within Health Trust?.

Yes. I mean, Health Trust is ticking up, right, as we work our way through supply chain issues. I think we're up to about 37% of our business is coming from Health Trust. We're probably getting up to about a $10 million run rate or so, up from about $1 million run rate when we started.

So I think that's going well, but we're also doing quite well in outside IDNs, which bodes very well for future contracting activities around premier, perhaps suspension and maybe eventually longer term Vizient.

So we have a strategy, and we have a play across all of those GPOs, and we're doing quite well at the individual IDN level, and many of those IDNs do roll up to those GPOs.

So I think our strategic accounts team is doing a great job as the data and value proposition continue to solidify and look strong, as we get better known from a branding perspective, all that works to our advantage in these contracting schemes.

And we're very excited and think we have a great opportunity to move forward with some of those or all of those..

Our next question comes from the line of Dave Turkaly from JMP Securities..

Tony, I'd like the sound of that LIVN program. So thanks for that. I guess I have a question here for BRAVO.

The 2-year follow-up, How many patients are done? Is it similar to the 75 in the 1 year? And when do you think that will be published?.

Well, we just got the 1 year published. We just locked the database and did the analysis on the 2 years. So the manuscript is going to have to be developed and then all that. It could be 6 months, I guess, before we get that in publication. But the data remains strong, solid. Patient count is roughly similar.

I mean there might have been some lost due to COVID between the 1-year and 2-year. But we'll have more to say. We don't want to -- we can't reveal the whole thing before we get it published. But we definitely wanted to go on the record to say that the 2-year results are not dissimilar from the 1-year results.

So things have held quite well on that study, we're pleased with it. And we're also pleased with all the ancillary data, which we took the time to go through today because I think the signal across all these different types of procedures and techniques is all pointing to a pretty darn low recurrence rate, which we're very happy with..

Got it. And I know BRAVO II is much longer. I think it's supposed to take more time.

But given that you're sort of the only option that can be used with the robot I imagine it's not quite as important as the original BRAVO, but I guess just any update there, any thoughts?.

Yes. I mean, BRAVO I actually has roughly 20 patients that were done robotically in it. So there's a subset already. And then certainly, the ReBAR stuff that was presented at SAGE is mostly robotics. So our robotic data set is looking fairly good before even BRAVO II. So Bravo II is going to be nothing but additive to what we already have in hand.

So those are also good signals that our results are looking good across all these different techniques and procedure types..

At this time, I would now like to hand the conference back to Mr. Tony Koblish..

All right. Thank you, Suzanne. So we're excited about the progress that we made this quarter and remain optimistic that we'll continue to generate growth from all of these strategic initiatives. We believe the foundation we have in place will allow us to generate growth through any -- through many market conditions.

Like I said, if the reverberations are going to be with us for a while, manifesting in labor shortages, et cetera. Our goal is to grow through it and outline how we're going to do that. So we think we have a great setup here, and we want to thank everyone for your time this afternoon and your interest in TELA Bio, stay tuned.

The best is still to come and stay safe and have a great evening. Thank you..

This now concludes today's conference call. Thank you for participating. You may now disconnect..