TELA Bio, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Telebio second quarter 2024 earnings conference call. At this time, all participants are in listen-only mode. A question and answer session will follow the prepared remarks. As a reminder, this conference call is being recorded. I would now like to turn the conference call over to Louisa Smith from Gilmartin Group.

Thank you, Marvin, and good afternoon, everyone. Earlier today, Telebio released financial results for the second quarter of 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 filing, changes in surgical procedure volumes, the regulatory environment, sales and marketing strategies, capital resources, or operating performance. With that, I'd now like to turn the call over to Tony.

Thanks, Louisa, and good afternoon, everyone. Thank you for joining Telebio's second quarter 2024 earnings call. During the call, I'll provide updates on our business and strategic initiatives, after which Roberta will elaborate further on Q2 results before we open the call up for questions. During the quarter, TELA faced some transient challenges that we were able to manage through and still grow revenue 11% to $16.1 million. Demand for our products remained strong in the second quarter, and we do not expect these adverse issues to persist into the second half of 2024. The biggest challenge in the quarter was a ransomware attack at our most recently added and consequently fastest growing GPO customer that consists of approximately 150 separate hospitals. The customer detected the attack in the second week of May and resolved it two weeks later, but it appears that the return to normal operations may have taken a couple of additional weeks. As a result, this customer has substantially reduced surgeries for about a month of the quarter affecting usage of both our hernia and PRS products. We estimate that this negatively affected our revenues by 1.25 million to 1.75 million during the quarter. Separately, one of our largest single hospital customers in our most successful territory also experienced a similar but independent cybersecurity event during the quarter, which we believe reduced surgical volumes and adversely affected our sales by at least 250,000. Finally, Like some other market participants, we saw some lightness in procedure volumes in the second quarter, which was exacerbated in our case by the departure via retirement, or in one case, the death of several surgeons who were reliable users of our PRS product. We believe that these challenges were confined to the second quarter, and sales in July bolstered this conclusion. We have a number of initiatives ongoing that I'll describe shortly, and based on current Q3 revenue trends, and the implementation of those initiatives within our sales organizations, we continue to expect to deliver sales of 74.5 million to 76.4 million for the year, reflecting growth of 27.5% over 2023 at the bottom end of the range. Essentially, we expect the second quarter headwinds to affect the timing, but not overall delivery of revenues in 2024. As it relates to our product portfolio, We continue to receive positive feedback from surgeons who have utilized the two products we launched in March and April, Liquifix, the only FDA-approved liquid adhesive for internal use in hernia surgery, and Ovitex IHR, a TROCAR-compatible next-generation soft tissue repair platform designed for inguinal hernias, specifically for use in laparoscopic and robotic-assisted procedures. IHR is available in three configurations, and complements our existing product portfolio and allows for further penetration into the inguinal market, which has historically been dominated by permanent synthetic meshes. Across the market, we're seeing a deliberate shift away from permanent synthetic mesh, and our inguinal product is poised to capture share as part of that underlying market trend. Very few players in the space are as well positioned as Tela to be an alternative to the plastics predominantly used in inguinal repairs. In the second quarter, Ovitex units grew 29% year over year, with a greater share of growth among the smaller units that are employed for inguinal hernia repairs, including in robotic and laparoscopic procedures. We expect to see continued adoption of Ovitex IHR as we educate surgeons on the benefits of this product and create greater product awareness in the market, particularly around its ease of use within robotic cases. Outside the U.S., we are experiencing significant momentum in Europe, where OVETEX was launched in 2019. As a reminder, OVETEX PRS has not yet received CE certification. The hernia portfolio is now sold in seven countries, Great Britain, Austria, Germany, the Netherlands, Switzerland, Spain, and Italy. In June, we secured a long-term agreement with the group purchasing organization, Santa Enikoff Logistik, GMBH of Ismaning, Germany. Santa is the largest GPO in Germany, and this contract provides OviTex access to Santa's 350 corporate partners in the country. We achieved 2.4 million in sales in Europe in Q2 versus 1.5 million in 2023, with year-to-date unit growth of 87%. In the second quarter, EU revenues were 15% of our total revenue, with the same gross margin as in the U.S., given the structure of our agreement with our manufacturer. As a more recently launched product market, we expect continued strong growth from our EU colleagues. We look forward to updating you soon on a collaboration with the National Health Service in England regarding Ovatex, so stay tuned for that. We have continued to make significant strides with our education efforts. In Q2, we educated over 300 surgeons globally through tele-bio labs and various peer-to-peer training programs with a strong focus on using Ovitexin minimally invasive and robotic procedures. These programs include comprehensive VIP visits to our Malvern headquarters, cadaver labs in both the US and EU, and various other educational sessions. One standout event was the Abdominal Wall Reconstruction Symposium in Las Vegas in May, which saw our largest attendance to date with 68 healthcare professionals engaging with our products. Additionally, we participated in several national and regional conferences with exposure to thousands of surgeons and attended two exclusive meetings hosted by Intuitive Surgical. Intuitive Connect, which hosted more than 1,000 general surgeons who used the DaVinci robot, and Women in DaVinci Surgery, a smaller but equally impactful opportunity for Tela. Given Ovatex's unique compatibility for robotic hernia repair, we are excited to deepen this relationship and look forward to attending Intuitive 360 in September. We are also gaining momentum on the podium of key industry meetings globally and in medical journals. TELA is now up to 43 published or presented works on Ovatex. We see these events and publications as a key driver behind surgeon education and adoption within the context of the transition away from permanent synthetic mesh. As we continue to gather evidence about the clinical efficacy and low recurrence rates associated with Ovitex, the market feedback remains positive, even among surgeons who tend to be slower or more conservative adopters. We are driving awareness and expanding market share with the breadth of our portfolio and are committed to offering premier products for hernia repair and plastic reconstructive surgery. both of which are serving preference-driven markets. On the commercial side, we have a maturing sales organization now led by Greg Firestone. In May, we appointed Greg as Chief Commercial Officer to drive our next phase of growth by refocusing the U.S. sales force on balanced, data-driven selling. Greg has been pivotal to the Telestory since 2017, supporting our commercial strategy and securing contracts with key GPOs and IDNs. He has experience navigating GPO and IDN contracting and will be instrumental as we secure further access to new organizations. Greg is already enhancing sales rep training, increasing operational efficiency, and refining productivity metrics across the organization. He and we are committed to having one of the best trained sales forces in the marketplace. I am pleased with the progress we made in the second quarter. We have a mature sales team in place, we are driving operational leverage, We have our eye on profitability in the near future, and our guidance points to our expectation of another year of very strong growth for TELA. With that, I'll turn the call over to Roberto to provide more specifics on our financial results.

Thanks, Tony. Revenue for the second quarter of 2024 grew 11% year-over-year to $16.1 million, with revenue from Overtax growing 11% and Overtax PRS growing 9% in the period. The double-digit growth was primarily driven by an increase in unit sales of products due to the addition of new customers, increased penetration within existing customer accounts, and growing international sales under our expanded commercial organization. This is partially offset by a decrease in average selling prices caused by a shift in product mix as our strategy to more broadly penetrate the inguinal and minimally invasive per new repair markets showed success. As Tony mentioned, there was one larger and a couple of smaller adverse dynamics affecting the quarter that we do not expect to meaningfully affect revenue in the second half of 2024. Growth for the first half of 2024 was up 24% over the first half of 2023, reflecting more general commercial performance before the customer-focused disruptions in the second quarter. Growth margin was 69% for the second quarter, compared to 70% in the prior year period. The decrease was primarily due to higher charges for excess and obsolete inventory as a percentage of revenue as a result of inventory purchases during the quarter. Sales and marketing expense was $16.7 million in the second quarter of 2024 compared to $14.6 million in the same period in 2023. This increase was mainly due to higher compensation costs as a result of our expanded commercial organization, increased travel expenses, and a marketing distribution fee which offset lower marketing expense. General and administrative expense was $3.6 million compared to $3.5 million in the same period of 2023. R&D expense was $2.3 million in the second quarter compared to $2.5 million in the prior year. The decrease is primarily due to lower study and development costs, which offset higher compensation and benefits. Loss from operations was $11.6 million in the second quarter of 2024 compared to $10.4 million in the prior year period. Net loss was $12.6 million in the second quarter of 2024, compared to $10.8 million in the same period in 2023. We ended the first quarter with $26.5 million in cash and cash equivalency. Turning to the outlook for 2024, we continue to 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. Additionally, we continue to expect operating loss and net loss to be less in 2024 than in 2023, even excluding the contribution from the divestiture of NIVIS. Operating expenses will remain steady or slightly lower sequentially over the course of the year, so that both operating loss and net loss should decline from quarter to quarter over the course of 2024, again, even excluding the contribution from the divestiture of NIVIS. Relatedly, cash consumption should be meaningfully lower in the second half of the year. Added to this, in the third quarter, we will begin to receive revenue share payments related to the divestiture of NIVIS. Over the course of the next eight quarters, these payments will sum to at least $3 million and could be as much as $7 million. With this combination of growing revenue, improving operating leverage, and incremental NIVIS payments, 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, Roberto. I'm pleased by the company's progress and resilience in the second quarter, and I'm excited by the enormous opportunity in front of us. I believe that Telebio has never been better positioned for success for several reasons. First, I've been very impressed by Greg's leadership of our seasoned commercial team so far, and I'm confident that he will do an excellent job in driving adoption of our portfolio of products. Second, we possess broad GPO coverage and have products that position us well for the ongoing shift. to robotic hernia repair. Finally, and most importantly, our products offer patients and surgeons unparalleled clinical outcomes at a competitive price. We are confident that this combination of essential factors for success can drive solid growth for TALA for years to come. So with that, I'll now ask Marvin to open the line for your questions. Please go ahead.

Thank you. At this time, we'll conduct a question and answer session. As a reminder to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Frank Tankinen of Lake Street Capital. Your line is now open.

Great. Thanks for taking the questions. I was hoping to start with a follow-up on some of the cyber attack commentary. Can you just help us understand a little bit better of what's really occurring at the account level when these cyber attacks occurred? And really what I'm trying to understand is when this occurred, are these procedures in backlog? Were the physicians able to use a different mesh? Were they using no mesh? And kind of how does that lead into the confidence behind the guide and backlog and those types of things to think about the second half of the year?

Yeah, Frank, I'll start that off. So to the best of our understanding, what was happening is the patient records are basically getting held hostage. So what that does is it creates a situation where to treat the patient, a lot of things that are done on the EMR are done by hand now. So prescription, note dictation, I mean, you name it, every aspect of a surgical procedure is impacted, so it makes the hospitals think deeply about which procedures they have to do and which procedures they don't have to do. From what we've heard, they've shipped patients off to other facilities. You know, that's not great for us if we don't have those other facilities up and running yet, right, as part of our implementation. So to the best of our knowledge, the attacks, even the secondary attack outside of the GPO system there may have been others, but those are the ones that affected us the most, were primarily tied to the patient medical records and sort of just locking up the hospital and their ability to function day in and day out.

Yeah, and so, Frank, what I'd add is if you do some research, you'll see some accounts where the affected hospital system was redirecting ambulances to alternative hospitals so as not to have them arrive at their emergency departments So for at least two weeks, they were doing very, very few procedures, if any. When they were able to lift the ransomware attack and regain access to their systems, they began getting up to speed somewhat slowly. It sounds like it took another couple of weeks before they were back where they were before. And so the procedures that we are involved in were either delayed or redirected to other locations. As in the COVID-19 experience, we expect that probably the PRS-type procedures were sent to other hospitals, more difficult to reschedule, but that the hernia surgeries were simply delayed. We don't think there's going to be a big backlog. It's about a month's worth of surgery, and hernia repairs in particular are reschedulable, one approach other than to the biggest surgery eventual hernia repairs is watchful waiting, so you can delay those for a month. Our expectation, though, is that as the hospital system gets up to speed, as the hospitals in COVID-19, they're going to prioritize more remunerative surgeries before the less remunerative ones, which means that hernia may take a little bit longer to get up to speed at those hospitals. All that said, we do have indications, particularly from the performance in July, that this is something that's been isolated to the second quarter and that things are pretty close to back to normal. And added to that, the initiatives that Greg has kicked off and the morale that we see in our sales force as a result of all that work, we feel very strongly about being able to perform in the second half and recoup the lost procedures that we got in the second quarter.

I'm just going to add a little bit more, Frank, to that color. Keep in mind, or if you recall, this GPO is super important to us. It's not the biggest, that's for sure, but the structure of the contract was the most favorable to us. Dual source contract, us and another player, and that other player was not the market leader. The contract had not annualized yet over the year, and so it's also our fastest growing, so acutely painful for us.

Okay, that's helpful color and maybe I'll sneak two in and I'll ask them both at the same time. How should we think about the split of revenue in Q3 versus Q4 to get to the guided range of 74.5 to 76.5? And then how should we think about kind of a blended Ovitex ASB with IHR now in the mix?

so I'll start with the first question so we expect more of the revenue to be in the fourth quarter if you think about the way you know what we think will be driving it our ability to regain it is the initiatives that Greg is kicking off and those have some ramping effects so you'll see more of an effect in the fourth quarter in the third quarter although we expect to see it in both as regards ASP We do expect ASP to begin to average down as we get more volume in the IHR space. As a general matter, we've always expected that our ASPs will, on average, be lower in the longer term because we entered the market at the larger end of the hernia repair spectrum, so with the large ventral repairs with big pieces, and we've always expected that we'd be moving into the rest of the markets by entering with smaller pieces. So we don't view this as a bad thing. It's an outcome of gaining greater share across the range of different repairs.

And it might be a little choppy, Frank, as we sort out the mix between the large complex cases with large pieces and the slope or the ramp rate of the IHR. Both products should grow, but it may be out of sync every now and then. But I think, you know, Definitely what Roberto said is correct. We want the volume at some point.

Got it. All right. I'll stop there. Thanks for the questions. Thanks, Frank.

Thank you. One moment for our next question. Our next question comes from the line of of . Your line is now open.

Hey, guys. Thanks for taking the questions. You know, cash burn was still pretty high this quarter. Was this, you know, mostly just due to not getting the leverage, you know, off the revenue growth or, you know, anything else to really call out here?

Sure, that's exactly it. If you think about the revenue having been higher or had it been higher, you know, we learned of the disruption partway through May, you know, towards the end of May, even though it began earlier in May. So there was not much opportunity to adjust expense within the second quarter. We did make some small minor changes in timing of expenses to try and offset it and give ourselves some more flexibility as we were doing the analysis to determine exactly what was happening during the quarter. But had we had that additional revenue on top of the OPEX that you saw in the second quarter, that should have all dropped to the bottom line. But we expect to get back on track with that as we indicated with the guidance. And then, you know, one thing that we believe investors may not be as sensitized to in the third quarter, we'll start getting that revenue share payment, which will be, you know, equivalent to 100% gross margin. Depending on how quickly that ramps, it could be more or less front-loaded over the coming eight months and up, eight quarters, excuse me, and that will obviously contribute to our cash position.

Great. And then just on... gross margins, what are your expectations really going forward given the IHR launch more broadly?

So IHR, the way we pay for the product that we manufacture from our manufacturer is with a revenue share. So we give them 27% of the revenue. That's true across our portfolio with very minor adjustments in certain cases. So even though those products are low ASP, they should be fairly close to that standard 27% revenue share. We split the cost of shipping, so that takes about a percentage point or two off. And so the long-term goal of gross margin is about 70% plus or minus a little bit.

Awesome. And then just a quick one. What was the split this quarter between Opatex and PRS?

So, this quarter PRS was 30% of the total revenue. Right. A little bit down.

Got it. Thanks.

Thank you, one moment for our next question. Our next question comes from the line of Matthew O'Brien from Pepper Sandler. Your line is now open.

Good afternoon. Thanks for taking the question. Just one clarification question. What was the split U.S. versus OUS? Did I hear you right? OUS is $2.4 million in the quarter, up about 60%. Correct.

Correct, yeah.

Okay, got it. And then, you know, and I'm sorry to push your guys, but I'm looking at the guide for the year, and the low end of the range assumes about $42 million for the rest of the year, so $21 million, you know, on average per quarter. And obviously Q3 is going to be slower than Q4. it's just hard to get the model all the way up to that level. So what did you see in July, you know, from a growth rate? I don't know what you can share. And then, you know, why is it even the low end of the range the right number? It seems like, you know, we should probably go a little bit below that just given the disruptions that you saw and the fact that some of those cases, you know, you're not going to be able to get now because they went to other hospitals. So, again, why is even the bottom end of the range the right number? Sure.

So thanks for the question. First, let me start with July. As you know, our quarters tend to be slightly back-loaded. The first month of the quarter tends to be the lowest of the quarter, below 33% of the quarter. One of the things we look at on a quarterly basis is how that first month of the quarter looks compared to other first months of quarters. What I can tell you is that July was the highest first month of a quarter that we've had in our history. So that suggests that we are back on track for growth and that in particular because had the disruption that you've seen in the second quarter lasted into the third quarter that should have suppressed the July, you wouldn't have seen that kind of performance in the first month of the quarter. The second thing that makes us comfortable about achieving the amount over the second half that we need to to hit our guidance is the plans that we had in place even at the beginning of the year which we felt strongly about, and then what Greg has been doing since he took over a little bit less than three months ago. So he was instrumental in structuring our response to our disruption in the third quarter of last year in which we revamped our education of our sales forces in which we retargeted our compensation system and has extended that into this year and then took over in May, at the end of May, and has extended that and expanded it. And so what we're seeing with our sales force and how they're responding to it and the morale that they're exhibiting as a result gives us a lot of confidence about being able to make up the shortfall that we saw in the second quarter.

Yeah, that said, I think, Matt, it's going to be weighted a little bit more towards the fourth quarter, right, once all the programs and all the training and all the elements kick in.

Okay. I guess how much wiggle room did you really factor in? Does everything have to go perfectly for you to get to the low end? Or are there some other factors that we're deciding to consider to get you all the way there?

Yeah. So as we've been describing over the course of this year, we view this guidance range as a commitment to investors. So we placed it in a place where we felt comfortable that we had all the resources to hit it. And what we did going through the years said if we learn over the course of the year to performance in any one of the quarters that there's additional upside, we would adjust that guidance number later rather than trying to express the full amount of what could be achieved early on before we had some data points. So we feel very confident with that range. And we will be expending considerable efforts to make sure we get not just the bottom end of the range, but get pretty close to the top end of the range.

Got it. Thanks so much.

Thanks, Matt.

Thank you. One moment for our next question. Our next question comes from the line of Michael Sarcone of Jefferies. Your line is now open.

Thanks. Good afternoon, and thanks for taking the questions. I guess, can you give us a little more color? You talked about bringing on Greg Firestone, and then you mentioned he's refining some of the training processes and the productivity metrics. Can you give us a little more color on what specifically Greg is doing in terms of making changes and how that's going to drive incremental productivity?

Absolutely. So Greg's been with us for seven years, as you know. He's really been one of our top commercial guys along the way. but more focused on GPO contracting, et cetera. I feel like we made a lot of progress in getting the GPOs, and now we've got to transition towards synthesizing that attainment with implementation into the GPOs. One of the things that Greg is deeply focused on is talk track and messaging and training. There are subtle differences in talk track when you talk to supply chain, right, at a contract, at a hospital, at a GPO. You know, there's competitive dynamics with competitors, certainly. There's pricing and strategic dynamics, but the messaging is different, and I think the messaging is going to be inordinately important at the supply chain level as we go through this transition away from polypropylene, right? Polypropylene mesh has been the subject of these litigations. It's going to settle at some point in the future. And we're seeing lots of activity at the GPO level in transitioning for those companies that have polypropylene mesh towards other more natural repair products. So having Greg in the middle of this allows us to be strong when we need to be strong with GPO and contracting messaging, right? It's with supply chain. The other factor is Greg's been around for a long time. He's run sales organizations. He has a gravitas and credibility about him, which is very, very good for a young organization like ourselves. So he is commanding and is gonna demand accountability. And that's gonna drive efficiency, leverage, And part of that is training, right? So one of the brilliant things that he's done since he started, he's moving very fast, is rather than thinking in terms of broad brush with the whole sales force in terms of training and education and talk track and messaging, we did benchmark testing for everybody in the organization, whether they're sales leadership or territory managers, everybody. And we got a strength and weakness profile for everybody individually And it allows us to really customize and develop our people on an individual basis, which is going to strengthen their talk track around GPOs and continue to strengthen and talk track their way around the surgeons. The other thing that we've done that he's doing a great job is he's implementing our two surgeons that we have on staff. So we've had Bruce Friedman, general surgeon on staff now for a year or two. He's been instrumental in helping us do training and peer-to-peer discussions on the hernia side. But Howard Langstein has joined us as well, one of the unfortunate losses in PRS business. He was a big customer of ours up until recently, but he's retired. He was the chief of plastic surgery at the University of Rochester, a very sophisticated man, awesome presenter and teacher and educator. and he's being deployed as part of our PRS surgeon peer-to-peer educational programs and also supply chain as well. So, you know, Greg's been looking after the Salesforce, you know, as a co for the last several months, and it was just evident to us that he has the right stuff for all of these elements to take us to the next level. Thank you for that question. It was good for me to explain that.

Got it. Thanks a lot, Tony. And maybe one for Roberto. I think you did mention in the commentary You've got your eye on profitability in the near future. So maybe you can elaborate more on that. What kind of profitability are you talking about and timing and what we need to see to really get there?

Sure. So the goal is to keep OpEx flattish to declining over the course of this year. With revenue growing on top of that, obviously that drops to the bottom line and reduces sequentially our cash consumption, although there is some seasonality to our cash usage. But we expect that even next year, we should be able to hold OpEx flat, potentially even to declining next year, such that with additional year-on-year revenue growth next year on top of that OpEx savings, and then combined with the contribution from the NIVIS revenue share that can range from $3 to $7 million, that that together should get us to profitability, so cash flow break-even.

Great. Thanks, Roberto.

Thanks, Mike.

Thank you. One moment for our next question. Our next question comes from the line of David trickle a citizen JMP line is now open.

Good afternoon. Did you have a CCO that position in the past?

Yes, we did. Yeah, he was more of a traditional, you know, VP of sales type of guy. You know, Greg is a more senior executive who has more of a strategic, fulsome set of experiences.

And Chris Smith is still there.

No, VP of Sales has moved on. You know, we've focused the business around Greg and the senior leadership that's been in place now for the last couple of years. We have a group of area directors that report into Greg that are our most talented, most senior folks. They've been with us, you know, for years. So it's a very tenured organization.

And one last one, just, you know, as we think about this, NIVIS, the Revenue Share Association, I'm just trying to think about even just the back half of the year. I know it's over eight quarters, but could that be a million dollars a quarter? Is that a possibility or is that too much?

Yeah, so the structure of it is that we, for the first four quarters, we get 50% in each quarter of what the new owner sells for NIVIS. And then in the second four quarters, we get 25%. So depending on how quickly the new owner is able to ramp it, they could potentially sell $2 million in the third or fourth quarters, and then we would get half of that, which would be a million. Yeah, CEO has been quite optimistic in the past on the product's uptake, but it's just launching. month or so ago. Yeah, so it launched in the second quarter. That triggered it since the way the agreement is structured is that it triggers for the first full quarter of launch the obligation to set revenues. Thank you. Thanks, Dave.

Thank you. I'm showing no further questions at this time. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect