TELA Bio, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Telebio First Quarter 2024 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 call is being recorded. I would now like to turn the conference over to Louisa Smith from the Gilmartin Group.

Thank you, Michelle, and good afternoon, everyone. Earlier today, Telebio released financial results for the first quarter 2024. 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 may 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 annual report on Form 10-K and quarterly reports on Form 10-Q, 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 and pipeline opportunities product potential, the impact of various macroeconomic conditions identified in our filings, the regulatory environment, sales and marketing strategies, capital resources, or operating performance. With that, I will now turn the call over to Tony.

Thank you, Louisa, and good afternoon, everyone. Thank you for joining us for Telebio's first quarter 2024 earnings call. In this call, I'd like to highlight some critical milestones we hit in the quarter as well as update you on our continued strategic progress and ongoing growth opportunities. We've started the year off strong. First quarter revenue was 16.6 million, representing 39% growth over the same period in 2023, and our 13th consecutive quarter with growth of 35% or greater. We are capitalizing on the considerable momentum we generated in the fourth quarter, and our business is firing on all cylinders. As you will hear today, we are benefiting from the recent enhancements to our commercial team in addition to some key product launches that will enable us to drive significant growth through the remainder of the year. In April, we launched Ovitex IHR, a trocar compatible next generation soft tissue repair platform designed for inguinal hernias, specifically for the use in laparoscopic and robotic assisted procedures. Just like our other Ovitex devices, Ovitex IHR utilizes layers of ovine or sheep rumen embroidered with just enough polymer suture to provide additional strength and performance. All Ovitex devices are designed to leverage a patient's natural healing response, facilitate tissue remodeling, optimize strength, and minimize the foreign body footprint of synthetic polymer. IHR is available in three configurations and will complement our existing product portfolio and allow further penetration into the inguinal market, which has traditionally been dominated by permanent synthetic meshes. The initial response has been phenomenal, with debuts of the product at two recent industry events, the Intuitive Surgical Connect meeting and at the Society of American Gastrointestinal and Endoscopic Surgeons, more commonly known as SAGES. There are now 35 published or presented works demonstrating Ovitex's clinical efficacy in hernia repair. This includes a study led by Dr. Paul Zotek exhibiting a low recurrence rate of 1.2% across 259 patients who underwent robotic inguinal hernia tap repair using the rebar technique with an average follow-up of 1.5 years. Our medical training efforts are as robust as ever. In Q1, we educated more than 250 surgeons globally through telebio labs and other peer-to-peer training. with an emphasis on the use of Ovitex in minimally invasive robotic cases. This includes comprehensive surgeon VIP visits to our Malvern headquarters, experiences at several of our 14 case observation sites, cadaver labs in the US and Europe, and various other educational sessions. We also have a very busy schedule at industry and society meetings. Through March of this year, in the US, we engage with surgeons at 25 industry or society meetings, focusing on hernia, plastic and reconstructive surgery, abdominal trauma, and GPO purchasing organizations. In April, we had tremendous success at the annual Intuitive Connect meeting where they launched their DaVinci 5 platform, and we were only one of three invited companies who provide mesh for hernia surgery. Our invitation to this meeting was a pivotal milestone in further demonstrating our credibility and growing leadership in the robotic space. At the meeting, we had exposure to nearly 1,800 surgeons and saw tremendous interest in both LiquiFix and Ovitex IHR. Feedback from surgeon follow-up indicates surgeons who attended were impressed by Tela's prominent presence at the meeting. I am also very pleased to announce that in the first half of May, we reached some major implantation milestones. Over 50,000 units of Ovitex have been used in hernia and complex ab wall procedures, with 10,000 Ovitex PRS used in plastic and reconstructive surgery procedures. PRS now accounts for more than a third of TELUS sales, and its revenue grew 54% over the prior year. Of note, the long-term resorbable configuration of PRS, which launched in mid-2023, has grown significantly and now makes up 55% of the PRS portfolio. Further highlighting TELUS commitment to PRS and the opportunity it represents, on April 1st, we welcome Dr. Howard Langstein, the former Chief of Plastic Reconstructive Surgery at the University of Rochester Medical Center as TELA's Vice President of Medical Affairs and Surgeon Strategy. He joins TELA as a member of a strategic team driving awareness of the clinical benefits of TELA's products with surgeons and hospital administrators in the plastic and reconstructive space. On last quarter's call, We were coming to you from our national sales meeting where we launched the LiquiFix suite of products in the U.S., including both the LiquiFix 6-8 Laparoscopic and LiquiFix Precision Open Hernia Mesh Fixation Devices. These products allow for precise mesh fixation while eliminating the risk of mechanical tissue damage from alternative fixation methods such as tacks, sutures, or staples. They are the only FDA-approved PMA liquid adhesive devices for use in affixing polypropylene and polyester mesh in inguinal and femoral hernia procedures, and for approximating the peritoneum. The sales force received hands-on certification for the products at the national sales meeting, and we have seen tremendous interest at industry meetings since then. To date, over 87 surgeons have been trained on LiquiFix, and the product represents yet another addition to our complementary suite of products, that elevate Tela to top of mind within the surgeon's choice of offerings. We are driving awareness and expanding market share with the reach of our portfolio and are committed to offering premier products in the surgeon preference driven markets of hernia repair and plastic reconstructive surgery. I'll now turn the call over to Roberto for an overview of our financials.

Thanks, Tony. As Tony mentioned earlier, revenue for the first quarter of 2024 grew 39% year-over-year to $16.6 million, with Ovitex growing 31% and Ovitex PRS growing 54% in the period. These increases were primarily due to an increase in unit sales of our products and the continued expansion of our commercial organization. Each of these resulted in increased penetration of our existing customer accounts, as well as the addition of new customers. Gross margin was 68% for the first quarter compared to 66% in the prior year period. The increase was primarily due to lower charges for excess and obsolete inventory as a percentage of revenue as a result of improvements in our inventory management during the quarter. Sales and marketing expense was $17.5 million in the first quarter of 2024 compared to $13.5 million in the same period in 2023. This increase was mainly due to higher compensation costs as a result of the expansion of our commercial organization higher travel and consulting expenses, and additional employee-related costs due to increased headcount. General and administrative expense was $3.8 million compared to $3.6 million in the same period in 2023. This was driven by higher employee-related costs as a result of headcount increases, offset by decreases in bad debt expense and insurance expense. R&D expense was $2.4 million in the first quarter compared to $2.1 million in the prior year. primarily due to higher compensation due to an increase in employees, as well as higher costs related to pre-IDE activities for Obatex PRS and outside development of new devices. Loss from operations was $4.8 million in the first quarter of 2024, compared to $11.3 million in the prior year period. The decrease is driven by the recognition of a one-time gain of $7.6 million from the sale of certain assets, related to the NIVIS fibrillar collagen-packed device to memetics in March 2024. This recognition is subject to adjustment in future periods as we assess our estimate of variable consideration from the transaction. Net loss was $5.7 million in the first quarter of 2024 compared to $12 million in the same period in 2023. We ended the first quarter with $37.1 million in cash and cash equivalents. Turning to the outlook for 2024, We now project revenue for the full year to be in the range of $74.5 million to $76.5 million, representing growth of 27% to 31% from the prior year. Following a strong first quarter and continued positive dynamics in the market, we feel comfortable in increasing our guidance range as our products continue to win market shares. As we have said in the past, we expect operating loss and net loss to be less in 2024 than in 2023, even excluding the contribution from the divestiture of NIVIS. Moreover, we expect operating expenses to be reasonably steady over the course of the year, notwithstanding some typical seasonality and expense, and since we expect revenue to grow sequentially, both operating loss and net loss should decline over the course of the year, again excluding the contribution from the divestiture of NIVIS. We continue to expect that our cash and cash equivalents will be sufficient to fund us to profitability.

With that, I'll hand the call back to Tony for closing remarks. Thanks. Thanks, Roberto, and thank you, everyone, for tuning in this afternoon. I am excited by the progress the team has made in the first quarter, and we are just getting started. We've reached the point where we're able to compete with even the largest competitors in our space. We have a well-trained, experienced direct sales force and highly competitive products backed with exceptional data. Our data on the performance of our products is outstanding, and we continue to collect more. Tela is in a strong financial position, and we fully expect to take take share for years to come. I am excited by the Greenfield opportunity with IHR and the potential for LiquiFix to open doors that were previously closed to us. So in closing, I'd like to thank our team for their continued commitment to our mission and their relentless focus on driving growth. We are on the precipice of great things here at TELA and I'm eager to deliver on a year of strong top line growth and solid operational execution. With that, I'll now ask Michelle to open the line for your questions.

Thank you. To ask a question, please press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. One moment while we compile our Q&A roster. Our first question is going to come from the line of Frank Takanan with Lake Street Capital Markets. Your line is open. Please go ahead.

Great. Thanks for taking the questions. Congrats on the solid start to the year. was hoping to start with asking about sequential expectations. I know in previous calls and years, you've talked about Q2 being a seasonally strong quarter. I think there's some particular excitement around that going into it with a fully staffed selling organization, IHR, and a couple other factors. How should we be thinking about all these things and what it can translate into a sequential growth standpoint? Sure.

So historically, we have had sequential growth from quarter to quarter, and as Tony has pointed out, there tends to be a fairly healthy step up from the first to the second quarters. If you were to look at the historical data and adjust for the hiccup we had in the third quarter of last year, so maybe look at 2022, a progression like that in revenue is something that we would expect. And as I mentioned in the prepared remarks, we do expect OPEX to be fairly steady over the course of the year. such that that step up in revenue will drop down to the bottom line in the form of improved operating income.

Okay, perfect. And then maybe for my second one, I know there's been some development related to the synthetic mesh lawsuit out there. It seems like there's kind of a May 24th decision date. I'm not going to ask you to speculate on the outcome of that, but maybe help us think through how some of those potential outcomes could impact your business.

Well, that's the greatest hidden secret, I think, out there. But yes, there was a notice put out by one of the law firms that there had been a date set for some kind of mediation or arbitration, something like that. So we're obviously keeping a very close eye on it. We have a communication plan at the ready in case this breaks one way or the other. I think for us to really understand what it means, we'll have to understand what it looks like in the end, right? And then we'll be able to sort of game plan for some of the eventual knock on effects that come after that. But our position is clear and consistent from the beginning, right? We are a natural repair product. We founded this company with the mission of getting permanent plastic out of people's bellies for hernia repair as much as possible. as much as it makes sense to. We focused on products that are natural in their remodeling process, are soft, and do minimal damage, even if they have to come out at some point. Those are the basic tenets that we built the company around. And by and large, we've delivered on that. We have superb clinical data, our recurrence rate in these simple inguinal, ventrals, et cetera, where there has been a problem that the litigation is pointing out, Our recurrence rate is in the very, very low single digits. And so I think we are delivering on that promise. I think putting polypropylene plastic into people's bellies is not going to last forever. It's going to come to an end at some point. And there's very few players and products that are as well positioned as we are to be an excellent alternative. The addition of the IHR product and the LiquiFix gives us a broad product portfolio now that can do any of the procedures done with any polypropylene product in any setting with any technique, robots, laparoscopic, open, you name it. So we look forward to being able to help surgeons, help patients in the continuing future and keep going on our mission, which has been the original mission of the company.

And I'll just add a little bit of detail, which is that this was a notice in the federal MDL multi-district litigation focused in Ohio. It wasn't the Rhode Island cases, which are state cases. It was a notice that said that the next case in that MDL litigation was postponed and the parties were sent to mediation with a deadline later in May. The deadline presumably can be extended, and one would think that Bard, in fact, Dickinson, the defendant, would want to try and settle both the MDL cases and the Rhode Island State cases at the same time. That could be tricky to sync up, so it is pretty unpredictable, but the notice just did get us to finalize our plans in response to any potential settlements. which would be driven in large part by what Dickinson does post the settlement.

Got it. That's helpful, Culler. I'll stop there. Thanks, guys. Thanks, Frank.

Thank you. And one moment as we move on to our next question. And our next question is going to come from the line of Caitlin Cronin with Canaccord Genuity. Your line is open. Please go ahead.

Hey, thanks for taking my questions. You know, just to start off, my first question is on productivity. How is that trending, including, you know, your initiatives for balanced selling, and how do you feel about the bolus of reps that you brought on at the end of 2023?

Yeah, I mean, we feel very good about the bolus of new reps, and, you know, we've enhanced our training program significantly, and we're going to continue to enhance that training program almost to the point of perpetual training so that You know, we have the best trained team in the marketplace. We feel pretty good about the balanced selling. You know, there's already been an uptick in PRS as it relates to a percentage of sales. I think we were running about 30% of top line with PRS, and I believe now in Q1 we were about 35%, 36%. So I think that's the beginning of what we're starting to see in terms of, you know, a balanced selling approach. So we're still finding our legs with this, but overall, I think we're off to a good start. And we started the year with a front-loaded sales force, right? So last year and the year before, we were hiring, which made forecasting the exact number of reps at any point in time along with productivity a little more difficult. Here, we're front-loaded. We've got the full team in place for the full year. So it should allow us to focus on things like training and execution, which will result in more confidence and success in the productivity.

And one of the metrics we talk about is the time it takes for new reps to get to break even. And we have seen with the latest cohorts of new reps for which we have these data that it is still running at a bit under six months for new reps on average to get to paying for their own variable costs.

Awesome. And then how do you feel about cash burn this quarter and how you expect that to trend throughout the year?

Sure. So as I described from a P&L perspective, we do expect OpEx to be reasonably steady over the course of the year and revenue to grow on top of that such that, again, P&L metrics of profitability will improve steadily over the course of the year, ignoring the contribution from NIVIS. which makes things better for the whole year. There is some seasonality to our cash flows since we tend to buy additional inventory in the first quarter and we pay out bonuses towards the fourth quarter. So if you overlay that sort of natural seasonality on top of that P&L progression, you know, we feel comfortable with the cash burn and the way that cash is going to progress over the course of the year.

Great. Thanks so much.

Thanks, Caitlin.

Thank you, and one moment as we move on to our next question. And our next question is going to come from the line of Michael Sarkone with Jefferies. Your line is open. Please go ahead.

Hey, good afternoon. Thanks for taking the questions. Thanks, Michael. Just to start, do you think maybe we can talk about how you're thinking about IHR contribution for this year and maybe, you know, what you've got based into 24 guidance?

So there are two dimensions to the IHR contribution for the year. So the first is, just as a reminder, we're already a participant in inguinal hernia repairs. We do have products that are currently used, even in robotic, going down pro-cars. Roughly about 16% of our revenue previously was in inguinal hernia repairs. So we expect that IHR will have fairly quick pickup uptake amongst the surgeons who are already doing inguinal hernia repairs using our products. In addition, there's a lot of greenfield opportunity, as Tony mentioned, to introduce the product to physicians who are maybe using synthetic meshes and are familiar with our products but wanted something a little bit more targeted for inguinal repairs. And so we expect to see some pickup from that as well. So we haven't quantified that exactly and what the breakout of that in the $74.5 to $76.5 million for the year is, but we do expect it to be a noticeable contribution to that amount.

Yeah, I'll add to that, Michael. We're off to a good start, you know, just a couple of weeks. We've got well over 50 implantations, which is great. And, you know, we're thinking about this, as Roberto said, but really a forward and backwards integration, right? So You know, this will allow us to get to new customers, which will elevate the rest of our product portfolio in ventral and complex ventral. But we started off in complex ventral and then, you know, more simple ventral. And a lot of those surgeons don't use us for inguinal. So I think, you know, reversing that, you know, our customers that are solid on the ventral side and the complex side, you know, I think are going to take a good hard look at us and adopt our products. on the inguinal side. So it gives us that complete product portfolio. I like the fact that it gives us mind share, routine usage capability, shelf space. And with the addition of LiquiFix, it gives us complete parity with our largest competitors. We have a very novel atraumatic fixation system that we think offers significant advantages compared to tackers. And now we've got a full range to go after the whole suite of procedures.

Got it. That's really helpful. Thank you. And just a second one, could you maybe just give us an update on your GPO contracts and how you're ramping there?

Yeah, so it remains the big three contracts that we have in place. You know, our revenue contribution from all the various GPOs, even the smaller ones, and the big three is, you know, approximately 60%. We think it's going to grow up to 70% in the near future. We're certainly on track for that. We're continually getting access via IDN supply chain and by smaller GPOs, and we are active in terms of looking at getting the next large GPOs. We're very confident that we're going to get them all. The large GPOs, I think their bid requests aren't due until much later this year, so it might be more of a next year event. But rest assured, we're very confident in our ability to continue to sell within the IDN framework, which represents over 40% of our sales today and has been very consistent. So we've also had great success in getting IHR on our existing contracts as a line extension, and we're actually starting to see some success with LiquiFix as a new technology. That's going to take a little more time to get contracts for LiquiFix, but the new technology designation, which we seem to be getting in certain places, is going to help us speed that up as well. So Everything on the GPO front is looking very positive.

Great. Thank you. Thanks, Michael.

Thank you. And one moment as we move on to our next question. And our next question is going to come from the line of Matthew O'Brien with Piper Sandler. Your line is open. Please go ahead.

All right. Thanks for taking the questions. Maybe for starters, just, you know, the Q and A result was quite good. Guidance for the year is well below what you just delivered in Q1, and I know there's a comp dynamic to think about, but just with all these different growth metrics or growth drivers that we're seeing out there, I guess why not raise the guidance range a little bit even higher versus what you did and then kind of what you've been doing over the last couple years?

Sure. Thanks for the question, Matt. You know, we approached our guidance this year as a commitment to our investors. So we are going to hit these numbers, and we put the guidance range where we felt very confident that that was doable given what we know, understanding that as we learned more over the course of the year, quarter by quarter, and if we felt more comfortable, we would increase it to reflect that. So, you know, we did do well compared to consensus this quarter. We raised the range by a bit more than that. Part of the dynamic is what sort of fractions we can use and what sort of numbers. But we feel comfortable about the slightly raised range. And as we get more data under our belts, we will reconsider the range going forward.

Okay, understood. And then, Tony, you've been talking about really strong training for quite a while. And I'm just wondering when we're going to start to see a little bit more of this this inflection point in terms of utilization? I mean, I know you're growing really well, but this is a massive market that you're going after. Um, you know, what do you think is needed? Uh, got all the data, you've got, you know, great products, indications, what's needed to really see this, this inflect from here. Thank you.

Well, you know, I, I call it the, the quasi, quasi parody, right? So, you know, if you look at our history, right, we, uh, we had no capital until, uh, the end of 2019, as you know. So commercialization really started in earnest in 2020. And we did well for two or three years, but we were hampered in building out our infrastructure, you know, due to the COVID start. But we grew crazy good even through that. But, you know, to be successful in this market, you know, parity in terms of Salesforce size, roughly, parity in GPO access, roughly, parity in terms of product portfolio capability across all types of procedures, roughly, right? I mean, we haven't had all of that in place until now, right? What we had was excellent proof of concepts, great data, you know, a very good mission that I think is well understood and appreciated by patients and some surgeons. And I think more and more surgeons are getting interested in our mission. So I think it's... I think what you're seeing is, you know, your surgeons tend to be slower, conservative adopters, which I think you want them to be. They want to prove things out or at first before they jump in. Uh, but you know, we are a company that started with zero on the ground, right? Nothing. And, uh, and so, you know, it's taken us time to methodically build this quasi parody with the big players. And, uh, I think we can go toe to toe now, starting, starting now at the start of this year. So, uh, I think this is the next phase of our evolution and growth, Matt.

Got it. Thanks so much.

Thank you. And one moment for our next question. And again, ladies and gentlemen, if you have a question at this time, please press star 1-1 on your telephone. Our next question comes from the line of David Turkley with Citizens JMP. Your line is open. Please go ahead.

Hey, good evening, guys. Tony, I might have missed it. Did you say, and I know Salesforce expansion is not a big part of this year, but are you still at 86 reps and six assistant reps?

We are at 87 reps and seven associate reps. Yeah.

Now, we're very consistent from last time, Dave. Got it. And then, you know, you mentioned the intuitive meeting and your commentary about, you know, some further penetration in existing accounts and adding some new. I'm just curious if there's anything tangible you could leave us with, maybe even in terms of new accounts, because that sort of seems like it would be a great opportunity for you guys to, you know, scope out some new surgeons. And I don't know if there's any quantifiable number you could give us, but I'd love to hear your thoughts on that meeting.

Yeah, I mean, the meeting was great for us. I mean, for a short meeting, we had well over 70 you know, really solid, validated leads. A lot, you know, there's a very nice percentage of those have already turned into cases or case commitments. You know, it felt like, you know, we were part of the ecosystem, right? I always say intuitive surgical is the apple of med tech in our time. And, you know, they only pick the best partners to go into their application store. And I felt like being in that app store was a big deal for us. We never take it for granted. We appreciate it immensely. And I think it's going to do good things for us, right? It's going to open up the world to seeing us who we are. A lot of the surgeons were seeing us for the first time. So that kind of thing takes time, but the Connect meeting was an excellent, excellent start. And, you know, we want to do more of those. I think, you know, the case observation sites is something that's also very, very good. You know, we've got many, many robotic surgeons that are now, you know, opening up their ORs for surgeons to come in and take a look. And, you know, that's great for the robot, and it's great for Ovatex, too. So, you know, I think, you know, I always think that, you know, Intuitive may be the giga GPO that sits on top of all the other GPOs, right? You know, we want to make sure that everything we do is in good standing with them and that we, you know, we focus on our compatibility with the surgeons who use the products, so the robots. So I think we're slowly, you know, attaining that, Dave. It's nothing but good. Great. Thank you. Thanks, Dave.

Thank you. And I'm showing no further questions at this time, and I'd like to hand the conference back over to Tony Koblish for any further remarks.

Thank you, Michelle, and thank you, everyone, for joining us. We appreciate your continued interest in Telebio. Have a great rest of your evening. Thank you.

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