Well, good morning, everyone, and thank you for joining us at this year's Canaccord Genuity Growth Conference. My name is Caitlin Cronin. I'm one of the medical device analysts here at Canaccord Genuity. I'm pleased to be joined this morning by Paragon 28, an innovative company focused exclusively on the foot and ankle market, with a broad portfolio of novel implant offerings and a connected ecosystem named SMART28. We'll begin with a brief presentation by the Paragon team, followed by a fireside chat, and I'll try to leave a couple minutes at the end for any questions from the audience. With me today is Chadi Chahine, CFO, and Matt Brinckman, Strategy and Investor Relations. Before we begin, I want to remind everyone of any relevant disclosures, which can be found on our conference and our firm website. With that, I'll turn it over to the team for a brief presentation. Thanks, Caitlin, and thanks for having us here. Always appreciate coming out to the Canaccord Conference. So, what I'll do is I'll open it up with brief highlights on the company for you all, and we'll, we'll dive into some Q&A after. So, we're Paragon 28. You know, as Caitlin mentioned, we're exclusively foot and ankle, so we're an orthopedic company focused and dedicated to the foot and ankle space. For those of you that aren't familiar with the foot and ankle space, it's an area that's just absolutely ripe for innovation. There's very, very high revision rates in, you know, in foot and ankle. It is the most complex piece of anatomy within the human body. You know, whether you're looking at the bone structure, you know, tendons and ligaments and the soft tissue that surrounds it, the fact that it's, you know, one of your most weight-bearing pieces of anatomy and that you're wearing shoes all of the time, there's a lot of room for complications and a lot of room for innovation to address those complications. It's still considered a very young segment within the world of orthopedics. So, you know, foot and ankle is an area that was sort of nestled under trauma for many, many years, and, you know, call it a decade or so ago, it started to become a more pronounced specialization within orthopedics. And, you know, there was born, you know, vis-à-vis, Paragon 28 and maybe some other innovators out there, highly specialized anatomical plating systems, screw systems, and other ways to address specifically the foot and ankle anatomy. The market itself, you know, for the investor community out there is, you know, about a $5 billion market. It's growing about 7% per year, and, you know, which is higher than what you see in some of the other orthopedic markets. So really, really nice growth across the entire cohort of players in the market. And, you know, we really, really are proud to push the pace of innovation in that space and continue to drive that growth. It's an area where there's no... You know, we've got up here on the highlights here that there's over 100 indications. All of those indications have different standards of care for treating them and really no true one way to tackle you know different indications. So it's not like hip or knee, where you might have a total joint arthroplasty as the typical go-to solution. You might have, you know, one of three or four or five different ways to tackle a particular condition. You know, bunion is one of those ones where we just launched, you know, two, three solutions to start the year, and we'll. I'm sure we'll get into that here shortly, but it's because there's always a different surgeon preference. There's always a different, you know, reason for why a patient might present a certain malformation or what have you. And we wanna make sure that people have absolute flexibility in their surgeon preference and their choice to treat patients, and then also, patients are getting the optimal solution for their particular condition. So it's all about being patient-specific and ensuring that we have, you know, a rounded-out bag for our surgeons, for not just our surgeon customers, but also for the patients. So that's a little bit about the overall market. A little bit more about the company, you know, founded back in 2010. You know, Albert's not here, but he likes to remind people that it was really a bootstrapped business where he and his co-founder, Lee Rosenthal, came together in a basement and decided to change the world of foot and ankle together. You know, again, Albert's not here, but I'll tell you, you know, his mother was the first investor, so very mission-driven, you know, wants to... We want to spend every dollar like it's our own. And that's part of what ripples throughout the culture of the company. We are and have been growing at about, you know, if you look all the way back to the start of the company, around 20% per year. This year so far, in the second quarter, we've grew 19.7%, and we are continuously, you know, working on improving our operating leverage. So, high-growth company, very, very innovative forward, and, you know, having a, a nice pathway to, to profitability, here in the coming years. So, maybe I'll pause there if, you know, in terms of the introduction, and, and we can get into the Q&A. Awesome. Well, thanks, Matt. You know, I wanna get into the Q2, because it's important, it was an eventful quarter, but I also want to introduce Chadi, who was just appointed as CFO, and just get a little bit of his background. So Chadi, since I have you here, it was announced last week that you were appointed CFO and EVP of Supply Chain Ops. Could you talk a little bit about your background and why you think it fits particularly well with Paragon's needs going forward? Absolutely. Thank you, Caitlin, for having me. So yes, I'm newly joined Paragon 28, but I've been in the orthopedic space for over 8 years, in the healthcare space for over 25 years with Abbott, Smith+Nephew, and Zimmer Biomet. Really, when I did my research, what Paragon, you know, before joining Paragon 28, I was very excited about exactly what Matt mentioned, the culture at the company. I spoke to external parties, doctors, reps, and I was really psyched in regards to the innovation, the attention to the patient, to the doctor. Matt mentioned the high revision rate continued to be an area for opportunity. And really this is a young company with a long history. I look forward as the CFO and responsible for supply chain, to bring this company to the next level. We've announced that our priorities is to be EBITDA positive in 2025, cash positive in 2026, and really, job one for me is to put the deliverables behind these priorities. I have a GM management experience, financial experience, as well as operational experience coming into that role. When we look at the P&L, the biggest driver of profitability and cash generation is managing properly the inventory, having the right inventory in the right place at the right time. Therefore, marrying these two responsibilities is critical for the right hand to speak to the left hand and deliver on these priorities. Mm-hmm. You know, and your second title is EVP of Supply Chain. What does this role entail, and how do you plan to start driving value here? Yeah. As I mentioned, you know, yeah, and this is, this is a common theme in the orthopedic space. When, when I remember asking consulting folks: What is best in class when it comes to inventory management in orthopedic? They, they said there is no best in class. This is, this is an area where there is tremendous room for improvement, and I think having, wearing the two hats is, is very important to make sure that there is no silos, that demand and supply are, are talking to each other. And as I mentioned, in the PNL and on the balance sheet, the importance of inventory to drive profitability and, and cash is, is critical. And having, having the responsibility of both and having the right teams working with me, will be critical to deliver on these priorities. That's great. Okay, maybe just getting into the Q2, you know, very eventful quarter. Let's start with the guidance. You narrowed your revenue guidance for the year, which lowered the midpoint to 16.5% growth for the full year. You know, as you mentioned, Matt, you've been growing 20%, and this brings you for the full year guidance lower than your longer-term target for 20% growth. How are you thinking about that long-term target going forward? Any updated expectations here? So I'll take that, Caitlin. So when we looked at Q2, we had a tremendous Q2, 19.7%. We also realized that as the quarter was progressing and when the Q3 was starting, that there was choppiness. I would not call it softness; I would call it choppiness in the sense that there was a pocket of expectation that were not delivered, and we wanted to be transparent with the investor community on what we are seeing. And as we looked at our guide, that was from the beginning of the year, of a range of $10 million, we felt with five months left in the year, that it would be prudent to narrow that guidance and share with the investor community what we are seeing. So that was the reason why we narrowed the guide and recognizing that we will maintain that openness, transparency as the quarter progress and when we report again Q3. That's great. And then just, Chadi, this was before your time, but, you know, there were financial restatements that were announced a few weeks ago. Can you just briefly describe what those were, to everyone and, and if they've been resolved? Sure. Yes, we've announced on July 31 that we've had to restate our inventory. And with that, we've updated our 2023 full year and 2024 Q1. The driver of that was calculation of our excess and obsolescence, as well as the purchase price variance of our inventory. So all non-cash related adjustment that relate to the valuation of our inventory. We've found the errors. These were errors, calculation errors. We've corrected them. We've also did extra work to make sure that we don't have any other material misstatement. And now the work with the material weakness is on making sure it doesn't happen again. That is a process that we work with our auditors, and depending on the requirement, it could take between 12 to 18 months to you know, remove the material weakness. So again, very important priority for me, to make sure that controls in the companies are robust, and that is a priority for me from a talent, system, and process as I get into the role. Mm-hmm. So you also announced an operational efficiency program on the call. You know, what are the key initiatives here, and why did you guys decide that now was a good time to begin this program? ... Yeah, so we've to remind everybody, we've announced a 7% restructuring of our sales force. Not sales force, our headcount, an $8 billion annualized savings when it comes to this headcount. And for me, looking at this, this was, you know, a normal organizational hygiene for a company that went public 3 years ago, grew extremely fast from an investment point of view, and wanting to go back to its roots when it comes to being extremely stingy on the places where it doesn't affect our revenue growth, and also being intentional in our investment. And that was driven by simplification of our operating model, and in no way this is something that we feel will affect our growth commitment. We continue to be a growth company, but with priorities to be EBITDA positive and cash positive. With that said, we've announced the headcount restructuring that happened in August. So the annual savings, as I mentioned, are $8 billion. But there is other part also of the company that we are touching, non-customer-facing, marketing, travel, and G&A. So really simplifying the organization more than anything else to put us on a stronger footing going forward. That's great. You mentioned adjusted EBITDA and cash flow breakeven, and the program helping you get to those goals, and you also codified those goals on the call. Can you just remind the audience of when you expect those and the pathway? Yes. So, on the call, we've announced that the priority of the company, the leadership team, is to be the EBITDA positive in 2025 and the cash positive in 2026. As a CFO, this is really job one, and my role in the next couple of months is to put clear deliverables of when, what, and how we will do that. I have, in my review in the last days and weeks, this is achievable, and really we need just to put dot the I's and cross the T's on them. Then, you know, you mentioned some choppiness in the quarter. Just a little more color on what that choppiness was and if you're seeing it linger into the Q3? Yeah. So, as you know, we function in really one sub-segment of foot and ankle. So, fractured ankle, forefoot, flat foot, ankle, and Charcot. And across these five segments, we've had balanced growth, really, you know, we were very happy with that growth, but we saw a pocket as the quarter progressed, and especially in early Q3, choppiness in, you know, territories, elective versus acute. And that choppiness gave us a pause on what do we expect for the rest of the quarter. So, that is why, as I mentioned earlier, we wanted to be transparent. We don't wanna be aspirational. I think this is continue to be a very healthy, robust growth company, but we wanna make sure we are transparent of what we're seeing in the market. Mm-hmm. But, you know, again, during the Q2, you mentioned you grew almost 20%, which is, you know, which is very strong. Can you talk to the competitive environment and what you're seeing, currently? Yes, we're, you know, like everybody, we heard that, you know, across the board, and specifying foot and ankle, that there was softness that they saw. We did not call it softness because, as I said, it was not across the board for us. It was not continuous or consistent. And we wanted to be prudent when it comes to our performance. We're definitely, you know, seeing that we're taking market share, so that is very exciting when we are growing 20% and the market is much less than that. So that bodes well for what's coming. However, we again, I repeat, we wanted to be prudent as we are only five months left in the year, and what the choppiness we saw at the early Q3 gave us an opportunity to narrow the guide. And then just, you know, last few minutes, turning to new product launches, and digging deeper into these. You're always really prolific from an R&D perspective, but it seems like this year you've launched some really transformative products. In the Q1, I think some important ones, Precision MIS Bunion and the FJ2000 Power Console and Burr System, and then in the Q2 and beyond, the Bun-Yo-Matic Clamp full launch, as well as the R3FLEX Stabilization System. You know, why are these products, really material portfolio launches for you, and what areas of the market do they address? Yeah, for sure. So maybe I'll hit on that. Starting with the products that you saw on limited market release at the start of the year, that's Precision MIS, FJ2000, and we had Bun-Yo-Matic before, sort of as an intro to what is now SMART Bun-Yo-Matic. Those products I'll hit on quickly. You know, MIS surgery is continuing to become more and more prominent within the foot and ankle space. The reason why, you know, you've seen some of these other products maybe take off initially, is because the learning curve wasn't quite as steep. Precision MIS, because it's, you know, it's a lot of fluoroscopy, it's a lot of, you know, feel and touch, it takes some time. But, you know, one thing that I've always loved about Paragon 28, and I think Paragon 28 prides itself on, on the R&D side, is we're always looking for the best solutions out there. We're not just trying to sell a product or, you know, push a one-size-fits-all approach on any particular patient or any particular surgeon cohort. So, you know, we've launched both those products. It gives us what is now perhaps the broadest bag in forefoot, you know, across all of the competitive landscape. And gives all of our surgeon customers, you know, total flexibility on their approach. You know, the FJ2000, for example, that's a, that's a minimally invasive system for joint prep, so it works really hand-in-hand, nicely and complementary to our Precision MIS system, for treating bunion, for distal osteotomies. Bun-Yo-Matic, on the flip side, you know, you've seen probably a lot of clamps in the Lapidus space, come out. Ours is the only one out there on the market that simulates weight-bearing, you know, intraoperatively. So we're really, really pleased with that. It also, it gives people the full flexibility to use a plating system or a nail system. So, you, you could really take any approach that you'd like. You know, obviously, I'm sure we're gonna get into this in a moment, but we just launched our SMART Bun-Yo-Matic, where you can do a full-blown plan within about 10 minutes. You upload a CT scan or an X-ray, which is very important because it's you know, more widely accessible and it's more cost-effective into our SMART28 case management portal, and it'll come out with the exact measures that you need to take, the exact angles that you need to address with the Bun-Yo-Matic clamp. So we're really excited about that, and and we're really excited about how we position ourself within forefoot in particular. But you know, it doesn't stop there. You know, we're launching a lot of products in soft tissue. You know, we didn't really talk about it when we were introducing the market, but soft tissue is becoming more and more and more important as you treat any part of the bony anatomy within the foot and ankle. So as we continue to build that part of the portfolio, you're starting to see more opportunities in every single case for Paragon 28 to be the sole company in the room, in the OR with the surgeon. So really pleased about some of the products that we've developed here in the first quarter and into the second. That's great. And then you touched briefly on SMART28, and you announced the launch of SMART Bun-Yo-Matic this morning. And could you really just talk to, you know, what's launching with SMART28 in terms of the case management portal and, you know, your first module and what you expect going forward? Yeah, certainly. So we obviously have big hopes for, for SMART28, be it the case management portal, be it the future module, modules or our first module. So the case management portal is going to be the home really for everything's, everything SMART28 and really everything Paragon 28. You know, we, we did introduce it to the world, I think, about 4 days ago. There was a press release this morning about the, the SMART Bun-Yo-Matic and the case management portal, so we're really thrilled. That case management portal, it's, it's going to house, really our entire product catalog over time. You know, obviously, the SMART Bun-Yo-Matic, which is our first module, but we also were doing things like MAVEN for our total ankle replacement or our patient-specific implants. That's all found a home there as well. So surgeons will have you know, an increasingly robust portal where they're able to access that and really efficiently plan and prep for surgery. So that's one thing on the case management portal. One other thing I'll hit on, on that particular topic is it's not just you know, a database, it's not just a tool, but it's a communications platform. So they're able to contact our engineers almost instantaneously. They're able to contact our sales reps. So it's really seamless, and it'll have a ripple effect throughout our entire business over time. You know, on the first module, that's the SMART Bun-Yo-Matic, we're really, really thrilled to have that launch. You know, obviously, it was very anticipated, and it's going to be the first of many. What's really interesting, and I touched on this briefly, so I'll try to not be redundant here, but you can upload a plan, you know, be it CT, be it X-ray, and it takes about just under 10 minutes to completely map your anatomy and tell you exactly what the right correction is. And what's cool about the bunion, the Bun-Yo-Matic clamp is in today's world, or I guess in yesterday's world, before SMART28, you would get a guide, right? And it would just be a you know kind of an analog guide that you'd put on, and there was no ability for the surgeon to make any intraoperative adjustments. With the Bun-Yo-Matic, you can actually make intraoperative adjustments. You're not just married to that initial plan. So if you see that there's a millimeter of miscalculation that, you know, live in the case you want to adjust to, you can do that. So it's sort of intraoperative support with a plan that hadn't really been seen before, and that's what's really novel about our new system. That's great. We have a couple minutes left. Any questions from the audience? Okay, you know, at the last minute, if you guys wanna just summarize, you know, your thoughts about the company and, and where you are going forward, that you want to leave investors with. Yeah, I'll do that, Caitlin. So, as I mentioned, I've joined Paragon 28 where and was extremely impressed by the growth trajectory of the company, the historical growth trajectory. And as my colleague Matt mentioned, this is a young part of orthopedic; it is the fastest-growing part of orthopedic. And to have a company as innovative as Paragon 28 is really incredible. So I'm,
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