Good morning, ladies and gentlemen, and welcome to the TELA Bio's Fourth Quarter and Full-Year 2019 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to Stuart Henderson, Vice President, Corporate Development and Investor Relations for TELA Bio. Please go ahead, sir.

Thank you, Sonia, and good morning, everyone. Earlier today, TELA Bio released financial results for the quarter and year ended December 31, 2019. A copy of the press release is available on the company's website. Joining me 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 fourth quarter and full-year financial performance later in the call. 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 Forms 10-K and 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, product potential, 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, Stuart, and good morning, everyone. We appreciate you taking the time to join us today on our first conference call as a public company. For the benefit of those of you who may be new to TELA Bio, we are a commercial stage medical technology company focused on designing, developing, and marketing a new category of tissue reinforcement materials to address unmet needs in soft tissue reconstruction. Our OviTex and OviTex PRS products targeting the hernia repair and plastic and reconstructive surgery markets respectively, integrate layers of high-quality biologic material with polymer fibers in a unique embroidered construction. Our products are designed to improve clinical outcomes and reduce overall cost of care relative to other biologic-based materials and have been implanted in over 8,500 patients to date. Before reviewing our operational highlights, we continue to closely monitor the impact of COVID-19 on our customers, patients, employees, and business. We will provide additional commentary on that shortly and how we are adapting our strategies as we continue to learn more. But we would first like to review our strong finish in 2019 and the fundamental growth drivers for our business in 2020. 2019 was an exciting year for TELA Bio, characterized by strong growth and momentum in our business, driven by continued adoption of our OviTex and OviTex PRS product line and expansion of our commercial organization. We delivered $4.9 million in total revenue for the fourth quarter 2019, representing 100% growth over the prior year period, and $15.4 million in total revenue for the full year 2019, up 87% from 2018. At the end of 2019, we had 35 sales territories in the U.S., which is an increase from 22 territories at year-end 2018, and up from 30 at the end of the third quarter of 2019. We…

Thanks, Tony, and good morning, everyone. Please refer to our press release issued earlier today for a summary of our financial results for the fourth quarter and full-year 2019. After commenting on our financial results, I will also provide our financial guidance for Q1 2020. As Tony has already highlighted, 2019 was a year of strong commercial execution. Revenue for the fourth quarter of 2019 increased 100% year-over-year to $4.9 million. For the full-year 2019, revenue increased 87% to $15.4 million compared to the full-year 2018. The increase in both periods were due primarily to the expansion of our commercial organization, increased penetration within existing customer accounts as well as the introduction of additional products in our OviTex training [ph] franchise and OviTex PRS. Gross profit as a percentage of revenue increased both in the fourth quarter and full-year period compared to the respected prior year period due to the decrease of a charge recognized for excess and obsolete inventory adjustments as a percentage of revenue. Fourth quarter gross margin increased to 51% from 42% in the year earlier period. While full-year gross margin increased to 60% from 36% for the full-year 2018. Sales and marketing expenses were $5.4 million in the fourth quarter of 2019 compared to $4 million in the same period in 2018. For the full-year 2019, sales and marketing expenses were $18.1 million compared to $13.6 million for the full-year of 2018. The increase in both periods was due to the expansion of the commercial organization and related activity. G&A expenses were $2.5 million in the fourth quarter of 2019, compared to $1.5 million in the same period in 2018. For the full-year 2019, G&A expenses were $6.2 million compared to $4.9 million in 2018. The increase in the fourth quarter and the full-year was primarily…

Thank you. [Operator Instructions] Our first question comes from Raj Denhoy of Jefferies. Your line is now open.

Hi. Good morning.

Good morning.

Hi, Raj.

I wonder if I could maybe ask a little bit about sort of the complexion of revenue here in the first quarter. We are actually right in here at the first quarter and you've given $3.5 million to $4 million, which is down sequentially from what you guys did in the fourth quarter. So, I wonder if you could maybe just provide us a little bit of insight into how the months of this quarter have tracked to the first quarter? How you guys did in January, February, maybe how dramatic the fall off has been in March?

Sure, Raj. So, we don't intend to give exact sales numbers month-by-month. I think that would be a headache for all of us, given the fact that everything about our business from the way we incent and compensate our sales force to the traditional way our business and other Medtech businesses roll out through the quarter. It's a quarterly based incentive package and performance, right? So, generally, we get strong months in the last month of the quarter. I think in general terms, I would say that our January and February were within a reasonable range for us to attain our targets. We probably started to see a little bit of wobble in the back half of February. And then certainly, we started to see it in early March. One of our largest, most successful markets driven by our early attainment of access through some local GPOs is the New York City area. So, we lost that market pretty thoroughly early in the game here. I think in March, I would say that it's been fairly steady revenue coming in. We might be seeing a little bit of a drop off here as we close the month of March, but certainly at a lower level than what we would have been accustomed to with a normal strong March. We have, as you know, Raj, an added element that influences all of this in that we were awarded and started implementing the HealthTrust contract on February 1. So, we had exactly one month maybe of unfettered implementation, planning, and activity going. In that time period, we saw great activity. And I'll just give you a couple of metrics, right. So, in all of 2019, we had approximately new -- 40 new consignment accounts set up, signed, and implemented. In the first two months of the quarter this year, we had 32 consignment accounts in motion, a lot of those signed, sealed, and implemented and a lot of those in progress in the final stages. Once we get into that process of consignment implementation, it generally goes through, right? So, the uptick in our ability to get access and products on the shelf was very, very strong for the start of the year. And we believe that it was going to contribute greatly to March and then even more so in April. We're going to continue with those activities in the best way that we can. One of our mitigation strategies here during this next period is to push consignment inventory as much as possible in areas that are open to us. That includes old current consignment locations as well as any of these new consignment locations. So, if you look at a typical ratio of what the third month of any quarter would look like, we were set up for more than that, I would say. So that's probably the best commentary I can give on that.

No, no, that's actually very helpful. I guess, for my second question, and it might not be a really fair question, but you noted that there are really two dynamics taking place here, right. So, there's the reduction in volumes given everything that’s going on in the market, but then there's also this access issue, right, that your reps getting into hospitals and actually training and converting surgeons is probably a little lower than it would be. Maybe, I want to explore the first one a bit more. When you think about complex ventral hernias, particularly on the complex side, right, how long can these types of procedures be delayed? How much of a reduction have you seen in those procedures and do you -- when do you expect they will start to come back?

Yes. That's a good question. So, if you look at the complexion of our revenue in March, which obviously is the most impacted month within this situation. We are mainly seeing the complex ventral and ab wall procedures. I'm not going to say uniformly going on, but that's generally what we're getting in terms of consignment requests, our reps stepping in to be helpful where they can be. Those are the types of procedures that we're seeing right now. If you take a look back to the last couple of quarters and even the first two months of this year, our hernia business was broadening really, really well. Part of our ambition is to bring the concept of natural hernia repair to all patients to minimize the amount of permanent polypropylene mesh implanted into people. And so that means more inguinal procedures, more hiatal procedures, and more robotic procedures. And we absolutely have been seeing that migration. Our ratio or percentage of inguinal and hiatal procedures, if you look back to Q1 of '19, our inguinal and hiatal procedure count was about 24%. So far in Q1 of 2020, it's running at 35%. So, I think that's a tremendous indicator of our natural repair solution being adaptable across all hernia procedures. I think it's a good indicator of our compatibility with the robot. It's a very good indicator of our value proposition and the price point being acceptable, and it also is in the early stages of being fueled by the rollout of our LPR product range. So obviously, back to your question, this is just background, the inguinal and hiatal space is all pushable [ph], right? That's all pushable. I think there is a high percentage of the ventral procedures that are pushable, if they are in grade 1, 2 or maybe even some simpler grade 3. I think the really complex infected rough case is maybe with cancer, those are emergent and I think have a better opportunity of being done. If you look at the CMS guidance and grading system, I think our procedures fit into that 2A and 2B category. So, virtually all most except for the most excruciating emergent cases are probably deferrable. Inguinals and hiatals, I think can be deferred for a long time, potentially, certainly 3 to 6 month range if need be. And then, that probably holds for some of the simple ventrals as well. The complex ones, I think are depending on how complex they are. If they're infected, that's probably not very deferrable. But if it shift a recurrence, then the patient isn't very active and it's been hanging around for a while, those are probably deferrable. And of course, Raj as you know, anything that can fall into an AFC, which is probably a lot of those robotic inguinal is certainly deferrable. So I view our hernia platform as deferrable [indiscernible].

Okay. No, that's super helpful. Maybe, Nora, just quick one for you. So on the expense side, right, so I think you mentioned in the prepared remarks that your hiring plans are, I think, are reviewed here, given all the uncertainty. But even when you think about the expenses, for the fourth quarter operating expense is about $8.8 million, how should we think about that trending over the course of the year? You gave top line guidance for the first quarter, but how should we think about how will you manage your expenses through this period?

Yes, I mean, so we are not going to -- again, we're not going to give guidance on this, Raj, on a broad level. We are starting to think about our hiring plan, we are going to be more conservative about the scale up. Again, it's going to be important to try to position reps in the territory, but some of them -- some of the hiring plan has been deferred until May or until we get better visibility on what’s happening with COVID-19. So again, our goal, Raj, is provide more guidance in May, assuming that we can, but for right now we are just trying to be thoughtful about our cash usage.

Yes. So I will just throw a little color on that, Raj. We, from a sales force perspective, we're still putting offers out, but we're deferring the hiring date until later in the year. So we're keeping the machinery going. Our goal is to come out of this thing stronger and in better shape than we are today, right. That's one aspect of it. But one massive layer, I mean, the big lever that we have is our headcount, right. That's payroll. So if you look at our original operating plan to be at 60 reps by the end of the year, if we're in the low 30s right now, I think you can see that that's a massive shift in headcount as we think more rationally about bringing reps on given the situation. So that's a big fat lever that we can manage. And of course, P&E [ph] goes with that, the usual basic stuff. So that's probably the best way to think about it is headcount driven.

Well, that's super helpful. Thank you, guys.

Thank you. And our next question comes from Matthew O'Brien of Piper Sandler. Your line is now open.

Good morning. Thanks for taking my questions and sorry you have to go through this as your first quarter as a public company.

Just for all of us, Matt.

Yes. Yes, seriously. So just sticking on the breakdown between revenues in Q1, Tony, I know you don't want to get too granular on this, but how were things tracking specifically on PRS? Because I know that's a bigger growth driver for you guys over the next couple of years.

Yes. So PRS, if any product that we have in our range is going to be impacted by this. It's a product that's in its early phases of launch, right? So I can say that the interest from our new GPO partners in this category have been super strong. I mean, to the point where we're actually getting calls about implementation, right? The cost savings, the value proposition, I think are super clear. And we feel very, very bullish about the long-term prospect of this product, particularly with the new access that we've developed. However, that said, we are committed to doing this in the right way. And plastic surgeons are perfectionists and we want to make sure that we're launching this thing with the right amount of attention to detail. So our ability to do that live and in person is now hindered. So I would say, again, same thing, March and February, we started to see that tap out a little bit as well. That said, I think, we're implementing what we're calling a virtual selling power model, where we can use the power of virtual tools to help drive both the hernia platform and the PRS platform. So, for example, we are driving KOL webinars. We just finished up two days of intensive sales force training by WebEx. We've adapted all of that content to be as good, I think as live content, but interactive. We've just done our first of several surgeon VIP tours virtually and we are developing webinars and contents for supply chain [indiscernible] directors, CRDs, VCRDs, etcetera to continue the implementation process as best we can. One of the platforms that we're using to really drive this is we've hired a third-party service provider that specializes in telephone selling basically, I guess you'd…

Okay. And this all kind of dovetails into my next question. But PRS was going to be a big revenue contributor this year, given what's happening now, given the slowdown in hiring, which is completely understandable. Should we think about the business this year is when you come back with things, come back to really focus aggressively on hernias at established market, you can try convert people quicker versus a little bit longer selling process with PRS and that PRS -- that may come back a little bit more in 2021 and beyond?

Yes. So I would -- so right now I think it's hard for us to figure out, but I don't think it's unreasonable at all for you to take the rationale that you had, we had about the ratio of hernia to PRS and just apply it to whatever the restart looks like, right? So the restart, we don't know what the restart is going to look like, but it could be, where we see a -- a Q2 that looks like it's low. We see a Q3 starting to come back and then we see perhaps the Q4 that’s ahead, right, based on how this restart goes. These procedures are not going to go away. There's going to be a good percentage of these procedures that have to get done. And I'm hoping that, we're ready to step up and meet that challenge and the hospitals should be as well. These surgeons are going to get antsy, patients still need to be treated. So whatever ratios we had in mind for contribution, I think we just have to apply those ratios to whatever the situation holds. I think that's my best estimate for it right now. I think with PRS, there's probably an extra pull on it from the GPO feedback that we've gotten so far based on its superb value proposition. So I think that's the best we can do now. I think we'll know a lot more by the next call on how our virtual selling power goes, in the middle of all this.

Got it. Last one for me, just on the supply side of things and you guys addressed this to some extent. I just wanted to make sure this is clear, though. You've got a single supplier, obviously, the majority of your product comes from that area or from that part of the world. So still comfortable that things coming out of New Zealand will be unaffected by everything that's going on?

Well, I don't know if I'd use the word uncomfortable. What I will say is we're in good shape, right? So New Zealand is an organized country. They probably have a more compliant population and they've taken early measures from what we understand, right? So they've ordered all non-essential business to remain closed for a 4-week period. This is with only 100 or so cases. So it's unclear right now whether they're going to be deemed essential or not essential. We are deemed essential. So they're supporting an essential business. But they've got to go through some type of a process to figure that out. In the meantime, they've been running seven days a week, two separate shifts in case somebody gets sick, and I think they've done an excellent job of building up their work-in-process to support us. That said, if you look at our inventory position, our stock in Malvern, just what we have in our warehouse here in Pennsylvania, we have 10 plus months roughly of OviTex hernia on hand. And since we're very early in this PRS launch, of course, we have 23 months of PRS. So that does not include inventory that we could potentially move around in the field if this became a prolonged situation. But I think right now we feel very good about our inventory on hand and our ability to serve our customers going forward.

If I can just add …

Yes, please.

Matt, just as you know that we've got consignment inventory [indiscernible] the hospital as well as with reps. So we’re not concerned about [indiscernible] if they have to put it down for the COVID-19 period as Tony mentioned we have 20 plus months of inventory on hand here just on hernia.

Yes, and our partner has done a great job, like I said, Matt, of building ahead as well. They're ready.

Very helpful. Okay. Very helpful. Thank you.

Thank you. And our next question comes from Kyle Rose of Canaccord Genuity Inc. Your line is now open.

Great. Thank you for taking the questions this morning. So I guess, I just wanted to, lots have been asked, but I wanted to kind of touch on is the contribution of some of the new products in 2019 and how you were thinking about those, at least with respect to the Q1. And just really want to touch on the large sizes and really what we've seen the emergence of the robotic products. Can you just kind of help us understand how the uptake trended specifically from a mix standpoint in 2019, and then maybe kind of how that was looking at this through the first two months of the Q1 here?

Sure. Let me address the robotic question first. I think that's super important for us as you can imagine. As you look at the start, Q1 of 2019, approximately 62% of our hernia business was open and 38% of that was MIS with most of that obviously being robotic. As we shift to exactly what's been happening here in Q1 2020, such as it is, 55% of our procedures have been open and 45% have been robotic. So we get these implant data cards back from every procedure done. I think we have about a 50% hit rate of getting them back, 55% hit rate I'm getting the signal and we ask exactly how the product was used and what procedure. So we'd had a pretty big cash, maybe 1,600 cards or so, 2,000 cards stacked up and over the last few weeks we just inputted them into our database and got latest numbers. So, 55% of all of our cases right now have been tallied in this way. And as of Q1, the movement from 62% to 55%, down from open and then 38% to 45% essentially robotic. So there's been a great shift. That's been driven, I think, by the versatility of our product portfolio. Our [indiscernible] are robot compatible. I'll call them Gen 1 robot compatible and our LPR product, I'll call Gen 2 robot compatible is coming online. So we've got early experience with LPR range with the three new products that have been added to that range. That makes four total SKUs in the LPR range. And although early, the uptake has been good in terms of numbers and usage there. As far as the ratio of hernia to plastic and reconstruction, 80% plus at this point is hernia. Were there any other details in there, Kyle?

No, that was very helpful. I think you covered it there. And then obviously you talked about HealthTrust going live in the Q1. You gave the change in confined accounts year-over-year. But maybe kind of help us understand the magnitude of the combined accounts you have within HealthTrust now and kind of how that -- if and when or when we restart things from a normalization perspective. How quick of a bounce back you're expecting in those accounts or an uptake of utilization in those new accounts that you're opening? And then how much of that is also in the future on account based on, putting sales reps and things like that in those territories and regions?

Yes. So I'll give you a snapshot, right, of our HealthTrust footprint in Q3 of 2019. We had approximately 43 HealthTrust accounts that use product, and I think our definition was within the quarter. So whatever quarter we measure, we said, did they use products. And that's not a bad figure given that we were vectoring towards getting on the contract, which is great. So there might have been a little bit of softening and allowing some access. I can tell you the shift from Q3 to Q1, we are now over 60, 62 or more HealthTrust facilities that have used products within the quarter. So that's a great shift in a short amount of time. So I believe that those accounts should be able to restart once we get moving again. But don't forget our virtual Webinar program with supply chain, all our directors, DRD, DCRDs, it's going to continue for as long as it takes. So to the extent that we can get mindshare and that we can get focused, again, our goal is to come out stronger and be able to place consignment inventory at a quicker pace. And again, I just want to point out that in all of '19, we did 40 and in the first couple of months, we have 32 in motion as well. So I think our pace and our ability is going to be -- it's going to be strong.

Okay, great. I appreciate the additional color there. Thanks for taking the question this morning.

Sure. Thanks, Kyle.

Thanks, Kyle.

Thank you. And our next question comes from Dave Turkaly of JMP Securities. Your line is now open.

Thanks. I hope everyone staying safe and healthy.

You too.

Tony, you mentioned -- yes, the data, I think we're looking for 2-year data on 25 patients, 1-year on 50, 90-day for I think 75, all in this sort of 4Q, 1Q, any color you can give us or any -- I know you said submitted, but I'd love to just …

Yes.

… at a high level see what you think about it?

All right. Well, the situation takes away stuff, but it gives stuff as well, right? Not much stuff, but some stuff. And so the 2-year data and the latest data, I think is one of those things. So we've submitted four or five abstracts. They've been accepted or have a super high probability of getting accepted, all of those meetings have been canceled. So it stalls our ability to present on one hand. We're now going to shift to looking at whatever venues we can get this thing published as soon as possible. Our Chief Medical Officer has given me permission to talk, at least at the high level, so that we can give you some information. We are not going to be able to drill down into the details, we're going to have to save that for the official presentation venue. But what we can share as of today is that our analysis includes the first 20 patients at 24 months, the first 57 patients at 12 months and the first 84 patients at 90 days. So among the 24-month patient cohort, we have zero recurrences still, which is a great result and consistent from the last readout. In the expanded 12-month cohort, we have one hernia recurrence, so less than 2%. What's interesting is, is that one recurrence was in a [indiscernible] basis that was well above where the implant was placed. So officially it's a recurrence, but does the product fail and recur? No. So the data remain super strong, which is going to do nothing, but enhance our ability to demonstrate a great value proposition within our GPO partners.

Thank you for that. And thanks for all the detail on the cost. You guys really provide a lot, I guess just a follow-up on that. I know you were talking to Premier and [indiscernible] and some other large ones, I guess. Any update on where those stand today?

I don't think we're ready to discuss that yet. I think we've made progress, great progress on virtually all of them. One of them, a sub group within them, I think is viable for us. So, I think we're in good shape overall when it comes to the GPO. Our ability to demonstrate our value proposition we're getting more and more confidence in that and we're getting very positive feedback. So we'll have more to say that as we get them, but we're feeling pretty good.

Great. Thanks.

Thank you. And ladies and gentlemen, this does conclude our question-and-answer session. I would now like to turn the call back over to Tony Koblish for any closing remarks.

I want to thank everybody again for your time this morning and for your interest in TELA Bio. 2019 was an important year for our company as we nearly doubled our revenue, launched great new additional products, grew our commercial infrastructure to support continued growth and completed our IPO to capitalize the company. The fundamentals of this business are still strong. We're confident that we can navigate these challenges associated with the global pandemic. Our goal is to keep our employees safe. We want to help out hospital employees and our customers. We don't want to be a burden to them, but we want to be helpful to them. Our goal is to add value, and I hope that you all on this call are safe and keep your family as well. Thank you.

Ladies and gentlemen, this conclude today's conference call. Thank you for participating. You may now disconnect.