TELA Bio, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Telebio First Quarter 2021 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the conference over to Hannah Jeffery from Gilmartin Group.

Hannah Jeffery Thank you, Kathy, and good afternoon, everyone. Earlier today, Telebio released financial results for the first quarter of 2021. A copy of the press release is available on the company's website. Joining me today on today's call are Tony Koblish, President and CEO, and Nora Brennan, CFO. Tony will begin the call by providing an overview of our operational highlights, and then Nora will provide a detailed analysis of our first quarter financial performance. 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 forms 10 and 10 , which identify the specific factors that may cause actual results or events to differ materially from those described in these forward-looking statements. These factors may include, without limitation, statements regarding product development, product potential, the regulatory environment, sales and marketing strategies, capital resources, or operating performance. With that, I'll now turn the call over to Tony.

Thank you, Hannah, and good afternoon, everyone. Thanks for joining us today. So we are off to a strong start in 2021 with $5.9 million in revenue for the first quarter. This represents year-over-year growth of 58% and sequential growth of 3.7% compared to the fourth quarter of 2020. As we mentioned in our Q4 2020 earnings call at the end of March, we experienced COVID-19 headwinds in the beginning of Q1. As the COVID infection rates declined, we began to see an improvement in procedural volumes in February and March, and we realized our best month ever in March, and it has continued into Q2. In the first quarter, demand for our Ovitex product line increased throughout the quarter as the number of hernia procedures continued to rebound. As we have seen throughout 2020, our Ovitex LPR product experienced the most growth out of our Ovitex product line. For the first time in our history, minimally invasive procedures using Ovitex eclipsed open hernia procedures on a quarterly basis. The continued migration from open to robotic hernia procedures that we have been experiencing is in line with what has been reported by the major surgical robotic provider. This continues to develop and solidify our position and provide a natural repair hernia solution as an alternative to plastic mesh. This movement from open to MIS procedures is a bit of a double-edged sword for us in the short term. While we are pleased Ovitex has become a preference for many surgeons performing robotic hernia repairs, Ovitex LPR does have a lower average selling price. The difference in selling prices is strictly a function of size, as currently most robotic procedures use a smaller piece of Ovitex than a traditional open hernia repair. However, we are noticing that the robot is being utilized for more complex hernia procedures, which should lead to the use of larger size Ovitex products and ultimately higher ASPs. Long term, we believe this trend demonstrates our ability to become a major, broad product portfolio player. Turning our attention to Ovitec's PRS product for the quarter, sales were up approximately 150% year over year, but down sequentially over the fourth quarter of 2020. Based on our analysis of new and existing PRS accounts, we believe a pattern is emerging. Many of the surgeons in our new accounts have been trialing PRS before committing to using it in additional procedures. This is evident with our plastic surgery customers who perform reconstructive procedures. as many prefer to evaluate how well Ovitex PRS performs during a three to six month post-op period. Based on our current understanding of how our new plastic surgeon customers are trialing PRS and the cadence of new accounts, we are expecting our PRS revenue to continue to grow year over year as more plastic surgeons adopt the product. We are beginning to see the broad adoption with PRS with strength in April and May. As a reminder, the fourth quarter of 2020 was robust in terms of signing up new accounts, which we believe we will harvest and make productive in Q2 and beyond. On the commercial side, access to surgeons is steadily improving. New cities and regions are still difficult to manage, but overall, our access to surgeons in hospitals and during their office hours has increased. We continue to target 48 territories by mid-year. but we could increase this target if demand continues on this current trend. As we mentioned during our fourth quarter conference call, we are adding sales territories that align with health trust accounts. On that front, we are making solid progress on adding health trust associated hospitals. During the first quarter, the hit rate for our new health trust re-engagement program has improved. That being said, I want to reiterate there is still work to be done. Although we believe we are beginning to make good traction with many health trust accounts, It takes time from contract signing to implementation. We believe most health trust accounts are becoming more open to new product evaluations as COVID-19 hospitalization rates recede. Before turning the call over to Nora to review our financial performance of the first quarter, I would like to thank our participating surgeons and investors for making our key opinion leader webinar a great success. For those who could not attend this virtual event, We hosted two surgeons speakers who discussed when and how they use Ovitex for hernia procedures and why they avoid polypropylene mesh in certain situations. The webinar was very informative and I invite all of you who did not attend to go to the events page on the investor relations section of our corporate website to view a recording of the webinar. With that, I will turn the call over to Nora.

Thanks Tony and hello everyone. Please refer to our press release issued earlier today for a summary of our financial results for the first quarter of 2021. After commenting on our financial results, I will also provide an update to our financial guidance for the remainder of 2021. Revenue for the first quarter of 2021 increased 58% year-over-year to $5.9 million. While we experienced significant year-over-year revenue growth, we did experience increased volatility in demand for our products with COVID-19 cases and hospitalizations increased in January. This volatility lessened in February and more so in March 2021. Gross profit as a percentage of revenue was 59% for the first quarter, in line with the first quarter of 2020. Sales and marketing expenses were $6.3 million in the first quarter of 2021, compared to $5.3 million in the same period in 2020. This increase was mainly due to higher compensation, benefits, and commissions from additional sales personnel, offset by lower travel and consulting spend. G&A expenses were $2.8 million in the first quarter of 2021 compared to $2.5 million in the same period in 2020. This increase was primarily due to higher compensation and benefits and higher stock-based compensation expense, partially offset by a decrease in bad debt expense. R&D expenses were $1.7 million for the first quarter of 2021 compared to $900,000 in the same period in 2020. This increase was due to higher development costs and higher compensation and benefits. Lost from operations was $7.3 million in the first quarter of 2021 compared to $6.5 million in the prior year period. Net loss was $8.1 million in the first quarter of 2021 compared to $7.2 million in the same period in 2020. We ended the first quarter of 2021 with $65.8 million in cash and cash equivalents compared to cash, cash equivalents, and short-term investments of $46.7 million in the first quarter of 2020. Now turning to the outlook for 2021, We are confirming our revenue guidance in the range of $27 million to $30 million, representing growth of 48% to 65% over the prior year period. We will continue to assess the current environment and provide updates on our quarterly calls as continued uncertainty relating to the dynamic environment with the COVID-19 pandemic could maturely impact this projection. With that, I will turn the call back over to Tony.

Thank you, Nora. For those who have not yet read through the 8K we filed this afternoon, Nora has decided to pursue a new direction. On behalf of everyone at Telebio and our board of directors, I want to thank Nora for her many contributions during her tenure with the company, including her strong leadership through Telebio's IPO and follow-on offering. Nora, we really appreciate your dedication and we wish you all the best in your future endeavors. Now with that, Kathy, let's open it up to questions. Thank you.

At this time, in order to ask a question, you will need to press star 1 on your telephone keypad. Again, that is star 1. Your first question is from Matt O'Brien from Piper Sandler. Hi, this is Karine Ahn for Matt.

Thank you so much for taking the questions. So first, starting on Q2 trends, I know you're not providing actually quarterly guidance, but you said that April and May were a little bit stronger and doing well. Can you just add any more color on that? With some recent COVID resurgences, are you still seeing some pressures from COVID? And also, are we starting to see some of those newer accounts start to contribute?

Yeah, so thanks for that question. You know, I'm just sort of going to go through a bit historical from the start of Q1 through to, you know, where we are today. I'm not going to get into, you know, month by month. I don't want to fall into that habit, but I'm going to give you some color. When you look at Q1, almost 80% of Q1 sales came in in February and March. January was a really tough month, and we expected that. On our last earnings call, I said that we expected a tough start to Q1 based on the end of Q4. And it was really concentrated for us in January. But February snapped back fairly well, and March was exceptionally good. And that has continued into April and through the start of May. So I think we're looking at a situation where all of the work that we've done to get stronger during COVID is starting to pay off. We've stockpiled a heck of a lot of new accounts, right? If you look at the new account stockpiling from back to Q3 of 2020. We had 46 new accounts, 57 in Q4 of 2020, and 40 in Q1 of 2021. Now, all of these accounts haven't started contributing yet, but it's a heck of a good stockpile, and they're going to start contributing. We're seeing that start to happen March, April, May. So we're very bullish about our ability to step up and keep the business growing. So I think we just, you know, we're at that point now where we're going to start to see, you know, all the moving parts and elements that we put in place start to work.

Great. Thank you. That's super helpful. And then just one more for me on tele-live. Can you just speak a little bit on the clinician conversion you're seeing from that? And is that starting to translate to the top line or is it still too early to tell?

Well, I mean, all that new account work that I just mentioned, I mean, there's no other way that that happened other than tell alive, right, we, we brought on 22 new reps in 2020, basically to strengthen. And, you know, COVID was at its peak at that point. And, you know, most of the work that they were able to do was due to tell alive. So we had a situation where, you know, roughly 40% of our reps that haven't been around, you know, very long that came on in 2020 are doing about 20% of our revenue. And then we also have 40% of the reps, these are the ones that are a little bit more established, been around a little longer. They're running anywhere on an annualized run rate basis between 500 and a million or higher than a million. And so both of those groups of reps are very much benefiting from that tele-live And it's really been the only mechanism that we've had, especially for our PRS plastic surgery products, right? I mean, those we just, you know, threw open for launch in Q3 more aggressively or more fully. And so we're only a couple of quarters into starting to see that step up, start to materialize. So all of that really has been, you know, driven by the TeleLive program. We've put about 200 surgeons through TeleLive, and the productivity that comes out of that has been excellent, as detailed by all of those metrics.

Thank you. Your next question is from Anthony Patron of Jefferies.

Hi, and good afternoon, everyone. Congratulations, Nora, and good luck on the transition. Maybe... No problem. As we look at this year as we go through GPO contracting, just want to kind of revisit GPO contracting and sort of how that transition will continue to play out through the year in terms of additional GPO contracts, A, but of the GPO contracts that are currently in place, B, how we should be thinking about onboarding of new facilities through existing GPOs, and then as we look outward this year and perhaps into next, how many additional GPOs are out there that could be onboarded, and I'll have a couple of follow-up questions.

Yeah, so we're in two modes right now, Anthony. We're in health trust implementation mode, and we're in IDN mode. The other big GPO contracts I think are further out. The request for participation, et cetera, is going to come in the future. So everything that we've been doing here is really focused on Health Trust and the IDNs. Health Trust has been a bit of a struggle for some of the year last year because of COVID. They've literally stopped and started, you know, a couple of times as COVID has heated up and then cooled down. I think we're getting through that, right? I think as you look at what COVID does to the business, I think we're in a mode now where we're not worrying about hotspots all that much anymore. You know, I told our team our job is to grow, exceed our numbers, no matter what the situation throws at us, right? We're done with the whole, you know, COVID as a, you know, as a filling up the ICU beds and affecting electives. We have to find a way. And I think the last phase of COVID's impact is on the supply chain and their willingness to look at new stuff. And so I think we're just starting to see that get better and better. So even with all of that stuff going on, you know, we are – running about 40% of our total unit sales in Q1 have come from health trust accounts. And that's with a pretty limited ability to drive those dialogues. If you look at our IDN situation, four of our five top IDNs are growing, right? And they're growing pretty nicely, 15% to 25%. And our top five IDNs contain a mix of different GPOs that they're associated with, right, Anthony? So these IDNs, they tend to roll up to one or maybe more than one GPO. So we're having excellent success at the IDN level. which I think is going to help set us up for, you know, when the Vizient and the Premier and the resource group contract comes into play. They're not there yet, but as long as we're knocking down these IDNs and health trust accounts, I think we have plenty, plenty of open geography and turf to work with to have an excellent year. So that's the way we're looking at it, right? It's health trust and it's IDNs, one, two.

That's helpful. A couple quick follow-ups, and I'll hop back in queue here. One on the Bravo data, the latest round of Bravo data being out there, ongoing 100-patient study. Again, record low recurrence rates for hernia safety data. Just wondering, you know, how Bravo data is being received in the marketplace. You know, what sort of feedback are you getting? Is it resonating? And then the last one, of course, for me, I want to just clean up, I guess, the headcount commentary. Did you see, Tony, that by the end of this year, the target is for 48 reps? And if so, what would be the cadence of adding those reps as the year progresses? Thank you again.

Yeah, yeah. So let me, I'll take the second piece first. So, you know, it's interesting. I think our thinking is evolving a little bit. I think we're going to start to think and talk about a combination of things in our commercial organization. The first is going to be the rep count. We're running right now somewhere about 43 reps or so. Then the clinical development specialists, almost the missiles. This group, I think, is emerging to be quite important for us. We were running four or five of those ClinDev specialists. You know, now we just put offers out. We're going to be staffed up at about eight. So we may wind up trading a little bit, right, where there may be a little bit of a trade between reps and clinical development specialists because the ClinDev specialists are super important. on the PRS side for us. And as we're starting to see success and growth there, you know, there may be a way to leverage more productivity into the reps that we have with these clinical development specialists. They can cover big geographies. They can use Zoom. They can get on planes. You know, we have them working the whole country, you know, where they're needed. So I think, you know, there's a little bit of refinement, not much, in our model. But so I think when we're thinking about, you know, Salesforce build out, yeah, you know, we want to get to 48 reps. It may be 48 plus 6 or it may be a little less on the rep side plus 8 or 10 on the ClinDev side. So the ratio is going to be, you know, the total number may be similar. I think we're going to wait until mid-year, Anthony, and then, you know, we're going to see how we come out of Q2. We're feeling great about where we are with Q2 at the start. You know, the strength of the exit coming out of Q1 is persisting, which is terrific. And, you know, I don't think we're going to be shy, right? I think we're going to invest if we feel that it's the right thing to do. We might put a few more reps down on the ground as we go through the rest of the year. I don't have an exact number for you yet, but I can say we're going to hire clinical development specialists, right? We're at eight now. I wouldn't be surprised if we were at 10 or 12. by the end of the year. So it's going to be some combo. Thank you again. Thank you.

Your next question is from Dave Turkley from JMP Securities.

Good evening, and Nora will be sad to see you go. Tony, in the press release, you mentioned the mesh litigation on your KOL event. You know, one of the docs had done a survey that, you know, said that 94% of customers would prefer a synthetic option like Ovatech. So I'm just curious to get your updated thoughts there. Did anything new occur, or are we just kind of highlighting that that's sort of a tailwind for you in the year?

Yeah, I have some new information. I mean, you know, sadly and stubbornly, the litigation just seems stalled, you know, due to backlog or COVID. You know, our contact's have indicated that really not too much progress has been made. But I feel, you know, that the market is slowly shifting, right? I mean, that survey work was nice. You know, a survey is a survey. It sort of told us what we're feeling already, you know, when we talked to surgeons. But what we did is we had our data team start to look at all the sources of usage for all the different types of products. As of the last cut that we looked at, whether it's IQVIA or DRG data or what have you, it's straight up plastic polypropylene mesh seems to be down about 15%. And natural repair, and I'll say natural repair products such as ours, biologics, resorbable synthetics, are up. So at least in that market data, you know, forget about surveys. The data probably is, you know, a wider, better look. It looks like, you know, we're at the very beginning of an increasing interest in natural repair, you know, versus straight-up plastic polypropylene. So we're going to keep an eye on that IQVIA and DRG data and just look at the raw numbers. And I think that'll tell the story going forward, right? It takes a while for this for this phenomena to kick in. But make no mistake, it's being driven by patients, it's being driven by, you know, the publicity such as it exists today. So, you know, that's a trend we're going to take, you know, keep our eye on and it should continue to improve. We're also seeing it in our business, right? You know, our LPR product line is cranking, you know, 51%. of our hernia units went in either through the robot or laparoscopically. That's all stuff that is less complex and that's a great sign for us having a broad product range. Our goal is to be very compatible with the robot. Our goal is to be able to replace any product in any procedure anywhere in any hernia with a natural repair solution. And so if you look at sort of our internal trends with LPR and the 51% and you look at that 15% across the, you know, across the mesh landscape, you know, I think it's happening. It's slowly happening. We'll keep an eye on it, Dave.

I appreciate that. And maybe just a quick follow-up, maybe for Nora. You know, I get the guidance reiterated. This quarter was strong. It was almost what we had for second quarter. And we know second quarter's got the weird, you know, comp from COVID last year. So as we're looking towards the back half and hoping that COVID is sort of a non-event, can we view that as somewhat conservative? I think, you know, given your trends you're seeing on even the MIS and robotic, do you think there's a chance that you could even do better than that in the back half of the year? Thank you.

Sure. Thanks for the question, Dave. Sure. You know, we certainly think that we could do better, but it is to be conservative at where we're at now, again, until we get better clarity with respect to the hospitals, the supply chain, and COVID. I think we're going to stay at this level at this point.

Yeah, I think we'll reevaluate. Yeah, I agree. You know, we'll reevaluate at the end of Q2. I think there's a lot of wood to chop between now and then, so... You know, we're setting ourselves up for success. And I realize, Anthony, I never answered the Bravo question, so I'm just going to say a couple words on that. Yeah, you know, the Bravo data is excellent. It's highly differentiating, right? Until the whole thing is out at two years, I think, then it's just not going to have, you know, the full power. And by the end of this year, we'll have everything out at two years. We've put in the one-year data as an interim. We've put that into a journal. We're waiting to hear back. So once we get that published, you know, we'll be able to flash that one-year data very thoroughly everywhere. And then we'll do the same thing, you know, once we're through the two-year data. But right now the BRAVO data looks really, really good. And we expect it to finish off strong. And, you know, some other good news is, you know, Bravo 2, which is going to be a redo of that study but focused on robotics, you know, finally we're through the COVID, you know, IRB startup phase and, you know, and we're very close to starting to enroll patients there. So we're pleased that we're going to, you know, round out our clinical data quite well with full two-year and then, you know, that robotic study is just demonstrating further commitment to all things robotic with our ERNIA platform. Thank you.

And your final question is from Kyle Rose of Canaccord.

Great. Thanks for taking the questions, and Nora, congrats. We'll miss you. Tony, a lot's been asked, but I kind of want to start big picture, because in the last question, you talked about the percent going through LPR and robotics. So I guess a two-part question is, Talk about the backlog that you see developing in the market. If there is a backlog, what are your hospital and your clinical partners talking there just when we think about delayed procedures? Obviously, you're seeing in your business a shift towards more of the simple procedures like the MIS, using the LPRs. I'm just trying to understand if we see more of a normalization come in the back half of the year, Are we going to see this consistent flow of these LPR robotic-type procedures and then add on some of the bigger, more complex ABWAL procedures? I'm trying to understand what that mix might shift like towards the second half, because that would imply maybe some revenue acceleration into the back end, just purely on price.

Yeah, that's a very, very interesting question. So, look, I'll go back to the start, right, of what we were trying to accomplish when we first launched this natural repair anti-plastic hernia platform, right? We wanted to be broad. We wanted to have a range that could do anything in hernia. And I think we have that. And believe it or not, there's way more we can do with it. We're going to put out new products over the next few years as well that are going to help accelerate the breadth and the totality of our capability, which is good. But our initial starting point was moderate to complex ventral. That's where we wanted to start. That's where Bravo One sits. And we wanted to prove ourselves in these horrendous, difficult, complicated, contaminated, whatever the words are to describe these difficult ab wall procedures. And I think by and large we've done that and we continue to do that. We have a very, very superb value proposition in those procedures compared to any other product. Bravo One really, really backs that up. So step one is in motion. I'm not going to say it's complete because, you know, with more contracting and more access and more reps and more everything, that's going to grow. But step two was always from the beginning to leverage all of that experience and goodness in the performance of the product. If we could handle those procedures and we could make our product as easy to handle and implant as plastic, then we should be able to start to chip away at the simpler procedures. And it's always been the plan to set up to have that natural repair alternative. And so we're in the very early stages of starting to see that happen. And the LPR has been a catalyst for that for sure. You know, there's four or five sizes. We need more sizes, right? We need to keep buffing out. the product portfolio that's earmarked for the robot because we're learning. We're figuring it out, what we have to do to be as easy and simple to use as plastic. And no one else can do that with a biologic or natural repair product, but we can. So we're sort of in the third or fourth, we're in the third inning maybe on the moderate to complex. We're in the first inning on the simple and the breadth. It's going to be driven and pulled through by the robot and by all the product and data additions that we're developing to focus on the robot. So, yeah, I mean, it's working, right? The plan was a two-step plan from the beginning. That's what we're operating against, and we see it happening. So, yeah, we're feeling pretty good about where we are with that. The other factor, Kyle, that's really interesting is that I think PRS is going to help hernia. So, when we meet with these IDNs, GPOs, even health trusts, they want to talk about PRS first, right? That's where the massive cost savings exists. You know, up until Q3, Q4 of last year, we were like, no, we're in limited release, we're learning, let's talk about hernia first, we'll get to PRS eventually. And, you know, that isn't exactly where they wanted to start, right? Now, it's the opposite. We're saying, all right, you're interested in PRS? Let's talk about PRS. Let's get that moving. We'll lead with that if we have to, and that's going to help us get hernia on the shelf, and it should work synergistically. We haven't even seen that start to kick in yet, but I think that's going to start to happen as well down the line, just the relative weighting of each of our product lines in terms of cost savings and value proposition.

Great. Thank you very much for taking the question. Thanks, man.

And there are no further questions. I will now turn the call back over to Tony for closing remarks.

All right. Thank you, Kathy, and thank you, everyone, for jumping on. So, you know, we're experiencing improving sales trends last quarter and bleeding into the start of this quarter. We believe that, you know, we're just going to stop focusing on COVID and get on with meeting and beating our numbers. You know, the last remnants, I think, that we're seeing are this supply chain opening up. So let's just hope that continues. That's going to do nothing but help us. So we're optimistic about the future. We believe, as detailed here, that we're well positioned to take advantage of all of these improving trends. And thanks for your interest in the company, and stay tuned. The best is still to come. Thank you.

Ladies and gentlemen, this concludes today's conference call. You may now disconnect.