Good morning, everyone. Welcome to the 43rd annual JPMorgan Healthcare Conference. My name is Grace Cho, and I'm an associate on the JPMorgan Healthcare Investment Banking team. Our next presenting company is Paragon 28, and we're pleased to have Chairman and CEO Albert DaCosta and CFO Chadi Chahine, so with that, I'll pass it on to the team. Great. Thank you. How will we advance this list? Perfect. Great. Good morning. Thank you, everybody, and thanks for the opportunity to be here. My name is Albert DaCosta with Paragon 28. For those of you that have potentially heard this presentation, I apologize. There's going to be some repetitive information, but we'll want to communicate bits about the market and some things that we think are exciting for us. To begin, I think it's important to call out how complicated the lower extremity is, really from not only a skeletal aspect but a soft tissue balance. That, combined with the fact that we've got a relatively young market that has not been fully researched and described yet, means this market, or this segment, experiences still relatively high complication rates. For folks like us, it's an opportunity to not only participate in the market but be part of crafting the future of this space. That is really exciting for us. Paragon was established to do exactly that, first and foremost, to contribute to this market in a meaningful way, to see if we can bring down those complication rates and improve outcomes for patients suffering with lower extremity complications. The market is relatively broad. There's well over 100 indications for us to address. It's a $5.2 billion market or segment today, globally. The United States represents about 50%, 55% of the global market. It's growing about just over 7% year-over-year. It's a very exciting market, broad and dynamic market. We're a company that's exclusively focused in just foot and ankle. This is our excitement. This is what we eat, sleep, and breathe. I think that reflects itself in the products and the way we tackle this business, which is exciting. We have over 80 product solutions since the inception of our company to address foot and ankle conditions. And we're just getting started as we look at our pipeline of opportunities. It's almost as rich as the day we started. This market is really, really dynamic and exciting in that way. In 2019, we discovered our biggest opportunity, we feel, to improve outcomes for patients is going to be enabling technologies. And that was really the catalyst for us to go public at that point in time. And so we believe, and quite strongly believe, that enabling technologies is going to be our most significant opportunity to advance the science of foot and ankle surgery. And then our goal has always been, if you look at the origins of Paragon 28, we started in the basement in Birmingham, Alabama. We invested every dollar as if it was our own because it actually was our own dollars. My mom was the first investor. It was really important for us to take every single dollar and invest it in a meaningful way for this organization. So we prided ourselves on being skimpy on the things that didn't matter, hotel stays and meals, but invested every dollar in ways that mattered for the business. We were never skimpy in that regard. Our goal has always been to build the most balanced business that we can, growing nicely and balanced with profitability. Chadi will touch on that in a little bit. For the year, our range that we reported this morning is $255.9 million-$256.9 million. That represents 18.3% growth at the midpoint. Our quarter came in just above our expectations at $71.5 million-$71.8 million. Again, 18.3% year-over-year reported growth at the midpoint. We've got just over 500 global employees. That's not counting our sales force, which is mostly 1099 sales force. As I mentioned, we've got over 80 product families, 20-plus active projects, is something I'm going to touch on in a little bit more detail. We report 284 producing reps, a lot of opportunity to expand that, and maybe one of the key points to make here is 2024, coincidentally, turned out to be a really powerful year for product launches for us, so I'm really going to highlight some of those products that we introduced last year, which not only gave us nice momentum in the year, but we feel is going to give us some tailwind going forward from here. Again, looking at the market, we expect just over 7% CAGR through 2029. Very exciting market, given the fact that there's real work to do here. We're excited about purpose-built products. We're not bag fillers here by any means. But if we're going to touch something and develop something, our hope is that we're going to make something improve to benefit patients and to really bring us to the next chapter. And this market gives us a perfect opportunity, I think, to do that. You can see the diversity of this segment where we report five subsegments within the market segment. I'll touch a little bit on those. Each market brings a really unique need and patient population and considerations. And again, that gives us the opportunity to be really focused on this one particular area, but have the diversity to build a really balanced portfolio that gives us nice strength there, both in the trauma and elective side of things. We have about 11,500 specialists. Those are made up between foot and ankle podiatrists and foot and ankle orthopedic surgeons, people who specialize only in the lower extremity in the United States. In the international market, it's a little bit more less specialized, a little bit more on the extremities as a total or some more of your traditional general orthopedics, and we also have an aspect of the market, which really we haven't tapped into yet, which would be your traditional traumatologists who take any call that comes in, and your orthopedic pediatric surgeons who would treat children, so there's still a lot of opportunity. In total, the market has close to 14,000 call points for us. Looking at the runway for Paragon 28, this is really exciting. For us, even within this population of surgeons that I just mentioned, there are people who have preferences and specialties within those specialties. So as we introduce new technology, it's great for us to be able to open doors to new conversations that potentially we haven't been open to yet. And that is really the crux for us, is starting with product development and expanding our surgeon user base and making sure that we cover anything that affects patients from the lower extremity aspect. We're a top three player, or we're hoping to be a top three player here soon. We have aspirations to be the first pure-play billion-dollar foot and ankle company. And we're doing everything we can to march in that direction and still a lot of greenfield opportunities for us, both internationally and domestically. Our key priorities or objectives in achieving that goal really start with technology. We always talk about that being the tip of the spear for us. Technology is how we improve outcomes. Technology is how we open doors to new surgeon customers. Technology is how we expand our representative base as well. Bringing in enabling technologies to that is a key thing, which I've mentioned already, then continuously expanding our presence from a service and sales point perspective is really important for us. Our portfolio and the culture of Paragon 28 really match nicely with the clinically oriented salespeople, not your more traditional relationship-building salespeople, but your clinically minded people who think like surgeons, are trying to understand what the limitations are, what makes these surgeons concerned when they're in the operating room, and so our goal is to continually bring that culture to our sales force and expand our presence and be able to service these cases better. And then again, mentioning operational balance, which is something that's really important for us, again, given the origins of the company. If you're going to change the market and you're going to really improve what we know, that means we do unbiased research. Paragon has a history and a consistency of doing the research well before we have a product. We want to make sure that we're not biasing our own research. We know if you're paying the bill for that research, it's pretty easy to prove what you're trying to prove. And so we have a real commitment to doing unbiased research. And as we uncover gems and secrets and riddles, we present that to our surgeon base with medical education. And so bringing the information that we're finding, good or bad, is really important to us. And so we're constantly optimizing and finding the correct delivery method. We've got an amazing facility in Colorado. We've also got two mobile labs now that are traversing the country, and we're going to continually find the best way to bring the medical education opportunities, get surgeons the chance to really practice and touch and understand the concepts and philosophies around what we design and how we do it. Paragon, really, since the beginning of the company, late 2010 is when we were established. Really, we say about 2011 was our first full year. We've had a history of really dynamic product launches. I'd say on an average year, we launch somewhere between four to 10 new projects. The size and scope of that can fluctuate. 2024 was what I consider a pretty banner year in terms of launching really meaningful systems in some really key areas for us, and I mentioned that was pretty exciting. I'm going to call out some of those products in particular. We still have well over 20 products in development. And as I think about the next generation of projects, we still have well over 50, 60 areas that we need to address. That's the beauty of this market. And that's the exciting thing about our culture and our drive to innovate, is we have a lot of work to do. And we feel like we're just getting started, even though we just keep entering these new chapters as an organization. So these are some highlights of the products that we've recently introduced. Again, balanced, really spread across all the five subsegments within our segment. And that is a key thing for us. We want to make sure that we're not lopsided. And even the way we present to Wall Street, to the investor community, reflects that commitment. We're very careful not to call out any one particular product because we don't want to get in the pattern of highlighting one child over the other and changing our balanced focus, and that's really important for us, and it's going to continue to be. I feel like the size and scope or scale of the company today really allows us to invest in slightly larger scoped projects. We're starting to really hit some meaningful, longer duration projects that take potentially to develop, but more meaningful to support our surgeon customers and ultimately improve patient outcomes. To start, this year, we launched our first module. I know that was anticipated by us quite a bit. We made an acquisition in 2022 to acquire a company out of Finland called Disior, and Disior developed a three-dimensional modeling. They can take a DICOM image and convert that into a three-dimensional model. Really useful in diagnostics, really useful in predictive operations. So we can predict the correction of the foot and the position of the foot in three dimensions given certain procedures. For us, that was really the base, the foundation of enabling technology. So anything we bring on the enabling technology side will feed into the software. So that was a pretty significant piece for us. And in 2024, we launched the first module, which is the SMART Bun-Yo-Matic. And now, really, if you think about so many aspects of one diagnosing these patients and really understanding every aspect of the deformity that presents, we could start to build more patient-centric, patient-specific solutions, not just as a tool, but really in understanding what are the conditions that we're trying to treat for this particular patient. Our goal is longer term to start to enhance our knowledge about who's really performing well with certain indications and who's performing less effectively so that we can continue to optimize our algorithms for what solutions we bring to these patients. We launched this Bun-Yo-Matic where we could take both a CT or an X-ray. We can bring that DICOM information into our platform. Within about 5-10 minutes, we can convert that using automatic segmentation and convert it into an algorithm that is a surgeon's preference for treating that particular type of disease or deformity. The patient can then be given step-by-step information about exactly what's wrong, looking at their imaging on a three-dimensional plan, which is a little bit small, but you can see it on some of those images on your screen. We can show every aspect of that deformity with a clarity that's just not visible with an X-ray. So it's a really useful tool. We're really excited about it. And then we could take that information once the surgeon has fed all the parameters that he or she is trying to address. We can take that plan and convert those parameters into our Bun-Yo-Matic clamp. So it will tell you, "Bring this piece in by 3 degrees. Bring this one up, rotate it by 4 degrees. Bring this one over by 2 mm." And we can replicate that plan in the operating room with precision. So this is a really exciting tool for us. One more key thing here is we're really trying to advance our consideration for patient-specific instruments. Traditionally, when we deliver these 3D-printed patient-specific instruments, the requirement is that we make larger incisions so that we get enough contact surface area with our PSI guides to get a positive fit. We also have to scrape a layer of tissue off the bone, which is called the periosteum. For those of you that know, the periosteum tends to be the blood supply to the bone underneath it. We're really trying to modernize this to allow us to have that patient-specific calibration, but do it with smaller incisions and without compromising the blood supply. We're looking at really advancing even that aspect of bringing better technology to support our surgeons. This is a blow-up view of the Bun-Yo-Matic clamp. This device can be used with or without the smart algorithm. I would say probably the most critical aspect that we've got built into this clamp here is that little black pad that you see underneath the toes. That black pad maintains a reference, a weight-bearing reference to the floor throughout the entire procedure. I think a really important part of doing bunion surgery is getting the head height of the first metatarsal relative to the ground, relative to the sesamoids, and relative to the other bones so that we're not transferring weight to other undesired areas. That black pad gives the surgeon the confidence hands-off that they're representing that position throughout the entire surgery. If you think about it, the fact that the patient's sitting on a table, you can imagine that gravity is pulling the anatomy in a way that's not reflective of a weight-bearing position. So even little pieces like that could be really helpful in giving surgeons that reproducibility in these procedures. And it's purple. And everything purple looks a little bit nicer, I think, just a personal bias. I would say that this product, which too is purple, is one of my most proud products for Paragon 28 for our team to have really conquered a riddle that we've been trying to solve since the beginning of our company. Syndesmotic injuries, ankle fractures, the soft tissue surrounding the ankle fracture is really complex. Three-dimensionally, it's a marvel. And we've done studies to identify that the sensitivity here is well within a millimeter. So less than a millimeter of over-reduction or under-reduction starts this devastating arthritic process to the ankle, which subsequently leads to ankle arthritis down the road. And those patients will either get a total ankle replacement or an ankle fusion. So really understanding not only how sensitive that area is, but then how dynamic it is. If you look at the pressure in the joint there, it starts at about 5 newtons. And when the patient naturally walking goes into dorsiflexion, it accelerates to about 150 newtons of pressure in that gutter. So if you put a static screw, every time you step, it's resisting that additional pressure. It's not anatomically correct to put static fixation here. And so a couple of key things for the first time, we're able to tell you how much pressure you're putting on the joint with that little white meter that you see on the handle there. As that gets to the center of your handle, as we're dialing in the tension, it's telling you that you're getting close to 5 to 10 newtons of pressure on that joint. Once you hit the trigger and release the device, it locks itself. And then there's a urethane bumper within the suture device itself that allows that pressure when we go into 150 newtons to release and then recover when we go back to neutral. So this is truly a dynamic device. And the instrumentation to give the surgeon some confidence that they're reducing this thing correctly is really game-changing in our view. And we're really excited about having this. And not coincidentally, the market reception has been tremendous for this product as well. And you'll see a lot of the products we launch are not only really helpful for that particular indication, but they're really helpful from a combination effect. So we've also launched this year retrograde nailing for fibular fractures. These started out being used for patients that had compromised skin and concerns about skin healing. So we would go in through the distal end of the fibula and retrograde this nail in to fix fractures and stabilize fractures. I think what we're starting to understand is that this is an effective tool even for patients with normal healthy skin. It could be a more advantageous way to reduce some of these fibular fractures. Subsequent to that is we're really starting to understand more about the mechanics of the fibula. So as this bone stabilizes as we walk, but there's a torque that's natural in the bone. It's really long and it's skinny. So you've got really the two ends torquing in opposite directions in many situations. And so having static stabilization like a plate might actually resist some of the normal mechanics of this bone where the nail has the similar flex that the bone itself would. So we're starting to see this really take off as more of a primary way of treating ankle fractures. This nail has a lot of flexibility in the instrumentation and design to where we can use the nail to reduce the fracture while stabilizing each segment independently. And you can see on the image where we're combining this with the R3FLEX that I had on the previous slide. So we've got the soft tissue stabilization, and we've got really flexibility for the surgeon to tailor what exactly they need to do for this patient based on medical necessity. And that product has really taken off nicely as well, really exceeding our expectations there. And then on the total ankle front, these are some products we launched in Q4. We introduced a shorter stem tibia. You can see the stem on this tibia is different from the two short primary stems that we had in our other option. This one here is for patients that present with a little bit more of a varus-valgus deformity. They might have a little bit more soft tissue instability that we're trying to consider. We're looking at providing some additional stabilization. Our key is always making sure that the bone metal interface is as perfect as we can get it. The bone in the area where this stem goes could be really sclerotic and dense, and so it could be very difficult to tap and prepare that canal in the perfect orientation. So we've also provided a 90-degree drill that you see on the screen on the right side, your right side as well, that connects to the tibial trial tray and allows us to drill exactly 90 degrees matching the orientation of the tibial tray. So it's really increasing the precision of implanting the device and giving surgeons more flexibility and options to address a broader array of patient considerations when they're going in for total ankle replacement. And then one of the pieces that we included here, because it's a really exciting part in the forefoot market for us, is this Precision MIS. And this technique has been available in Europe for close to 20 years now, but it just hadn't taken off in the United States yet. And I think the primary reason we were hearing from surgeons is the learning curve was really high to do this. This is a small incision, percutaneous incision, MIS surgery for bunion correction, and the confidence to do these procedures and know that I've got the exact position I need without seeing the anatomy was very uncomfortable for surgeons, so we weren't going to jump into this procedure until we could make it reproducible without a learning curve of 20, 25 cases, and so we really emphasize the outrigger that you see on the screen there, that black device that helps the surgeon, gives them the confidence that they're aligning this thing. It also gives them micro-adjustments as they're going to make the exact correction here and then facilitate alignment of those crossing screws, which can be really tedious and actually add a lot of complexity to the surgery itself when done freehand. We're really excited if we can bring these options to surgeons in a way that's way more comfortable and reproducible than Paragon. We believe we're achieving something that's going to really support our surgeon base. Now with these smaller incision surgeries, you can no longer use a saw blade for a lot of these procedures. The saw blade has a longer sweep, and so you'd require a bigger incision. To do these procedures, we do typically a burr. The burr, you know, the speed and torque of that burr becomes really critical to a successful outcome. If we go too fast with the burr, we tend to char the bone as we're doing our preparations, and that can compromise the biologic healing of these patients. And so we introduced this year the first really disposable handpiece that has the exact torque and speed requirements for smaller incision surgeries, plus an arsenal of burrs that satisfy a wide variety of different approaches and techniques. And the efficiency that we're bringing to be able to dispose of the handpiece, it's completely sterilized and disposable. The box is not disposable, nor is the foot pedal. But the parts, the components you see on the left side of your screen are disposable. So that allows surgeons to turn more cases without having to wait for their devices to be re-sterilized, gives them a sense of confidence that it is the first time and only time used. Plus, it has all the exact requirements to do these surgeries effectively. And it's essentially the cost of a disposable drill, a couple of disposable drills. So we found a really nice reception to this device, and it's really supporting some of our other technology really well. Lastly, we just want to make sure that the company is constantly giving ourselves multiple shots on goal. We try to think of every opportunity in isolation, and we analyze what it would take to achieve certain goals for this organization with any one of these independently. Our hope is that collectively, there's always going to be opportunities for us to improve certain aspects, but collectively, we hope to beat or exceed our growth expectations and balanced financial requirements to make sure that we're constantly leveraging this organization. These are the things that we do: repetitions, looking at new surgeon users, bringing new technology to the market to feed some of those opportunities to bring new surgeons to medical education programs, and then looking at making sure that we can represent our portfolio, which we believe today for a standalone foot and ankle company is the most comprehensive portfolio in foot and ankle, and it's still growing as rapidly as it was 10 years ago. We're really excited about all those opportunities there. Then we mentioned some of our surgeon-based opportunities. Just looking at opportunities to bring better medical education to our surgeons, unbiased medical education. I think we've developed a rapport with our surgeons that we're going to bring meaningful information, not just glamorize everything that's positive, but bring them real opportunities to understand where these things go wrong, where there's complications, and we're using tools that we didn't have before. I took a weight-bearing CT of my foot, and we segmented it using the Disior platform, and it's really amazing because I noticed my right leg is a little bit shorter than my left leg. I'm giving you my own medical information, but I think it's HIPAA-friendly if I'm saying it about myself. But I can't stop analyzing the condition in my foot. I'm understanding really every joint, every aspect of my anatomy and how it affects my gait. My left foot has a different IM angle than my right foot. My pressure and density gradient is different on my right foot than my left foot. Everything is unique, and it's really giving me sensitivity to what patient-specific considerations mean. Our days of mapping surgery to anatomic landmarks that are different for every single person might be behind us, and we might be finding more effective ways to understand what the alignment characteristics and the real balance of a particular patient's limb, left and right, not to mention patient to patient. They're in our hands now. We're seeing it. I wish I could show you the animation of my foot. It is really powerful, and the tools that we've got today are so dramatic, and we're excited that we're on the point here where we're about to really transform and take massive chunks at a complication rates for foot and ankle. Our goal has always been to bring these down as close to zero as we can get, and we think we've got this in our grasp. So bringing that medical education, looking at sales force that can properly service and support these cases the best that we can, that someone's family member sitting on a table, that means a lot to us. And we take a lot of pride in making sure that everything we touch is going to help someone, either the surgeon in that case and ultimately the patient in that case. So with that, I would love to turn it over to Chadi Chahine. You'll hear less of me talking. Let him talk a little bit about the international and some of the things we're doing to leverage our financials. Thank you. Thank you, Albert. So great to be here. I'm Chadi Chahine, the CFO and Executive VP for Supply Chain Operations at Paragon 28. And as Albert mentioned, he covered innovation in our strategic priorities. He covered how we're doing in the U.S. And I'm moving now to our point number three in regards to international presence. We're relatively young in the international, but not that young, eight years. As I arrived into the company in August, it was important to focus on our core markets international. So while we are proud to be in 21 markets, we're really focused on five to six to seven markets: Canada, the U.K., Germany, South Africa, Australia. And we're mentioning Japan. We're in early innings in Japan. We're just pursuing regulatory registration in Japan, and we expect Japan to be a very important market for us in the future. We will do this in a balanced way, in a profitable way, and cash flow positive way, and you will hear me repeating these three terms throughout my presentation. We will do it right. We'll continue investment in medical education and training and launching new products. We have a long tail of new products. The U.S., of course, takes a big part of it, but as we look at the future, there's a long tail of new products that will come into international. Moving to the last point of our strategic priorities and really what put everything together is we have a history since the IPO of a balanced growth across all segments of foot and ankle. In fact, we are the only company exclusively foot and ankle present in the five key segments of foot and ankle. And that positions us very strongly for the future to capture that growth going forward. As Albert mentioned, we pre-announced this morning our Q4 and full year range, and that is exceeding by a little bit our expectations. We're very happy of that. And thanks to the new product that we've launched in 2024 and before for that matter, allowing us to continue on that growth trajectory. Having said that, we will do this again through continued commercial momentum and focusing on sustainable balanced growth. Moving into operational efficiency, as you are able to see, we've kind of reset the company when it comes to our gross margin. We've had a restatement that brought us to targeting our gross margin at 75% plus. And the reason why I say plus is we expect this to improve. We've purchased inventory at a higher price after the COVID pandemic, and we expect this inventory to be sold off in the market, and as we look at the prices that we are paying for our new inventory, they are at a lower price, but it will take time for that to be digested. One thing that I focused on, and when we arrived, there was the team has put in place the restructuring plan. We've had a reduction in force of 7%, generating $8 million in annualized savings, and we are pursuing this aggressively. In fact, we implemented most of it in Q3, and you're seeing the result of that in the reduction of operating expense as a percentage of revenue, and I expect this to continue into Q4 and into 2025. This is a key focus for us to really, as Albert started the presentation, a back-to-the-future moment for us is we've been a true steward of this company, and we became public. We've invested, pre-invested in a lot of the infrastructure, and now it's time to pay back on these investments, and that's what's happening. I expect this percentage to continue going down over the 2025 onward, and one thing the company and I were very proud of is that allowed us to be EBITDA positive for the first time since we became public, slightly, but that has really made the company feel great that we are able to be EBITDA positive. We were EBITDA positive prior to being public, and therefore that's why I say it's a back-to-the-future moment because we know how to do it, and that result in somewhat the most important when it comes. So we're growing double-digit. We're becoming profitable, and that's allowing us to improve on our free cash flow. As you are able to see, we've improved our cash use in the third quarter of 2024. And I expect this, while there will be some lumpiness depending on seasonality, I expect this to continue improving. And when I look at our commitment to be EBITDA positive in 2025 and cash flow positive in 2026, this gives me the conviction that we're going to be able to do that. And the way we're doing it is by strengthening our profitability, by leveraging our expenses, but also managing our working capital. Starting with inventory, we've built big inventory levels during COVID and after COVID. I think the whole industry was in that stage, but it's time now to put a lot of pressure on that number. And I've disclosed that our target is to be around 400 days in the IOH over the mid to long term, and we are on track to do this as we look at 2025 in that direction. And inventory, while it is a key component of becoming cash flow positive, and I wear my other hat of the supply chain operation, it is important to have ownership of that number. And while we want to service our customers, but we want to service them right, having the right product at the right time in the hand of our customer surgeon. And that does not happen by itself. We also focus on improving our collection, on creating partnership with our suppliers, and that is where we have a balanced working capital management that allows us to improve on our free cash flow. And I'm going to close the talking points. By the way, Albert started: our strategic priorities and objectives are clear. The head of this spear is innovation. Then this innovation will allow us to be strong commercially in the U.S. and internationally, and we're going to do that in a fiscally responsible way that is profitable, that is sustainable, and that is cash flow positive. Thank you. So we have a couple of minutes for questions. Grace, you have a question. Yeah. I can get started here. Last year or last quarter, you announced 969 basis points of improvements to operating expenses. What were the major levers behind that, and how do you expect that to trend in the fourth quarter? Sure. So I covered some of that. Definitely back to the future moment of operating leverage. The company became complex when it comes to layers. When it comes to, we were talking, Albert and I, is when prior to the IPO, one person was doing 10 tasks. After the IPO, as we built the organization, one task was being done by 10 people. And therefore, there was a requirement to simplify the organization. That started with the restructuring enforced that really gave us that simplification. And as I look at what we delivered in Q3, and I look at the preliminary view that I have from Q4, I see, while in line with our expectation, a significant improvement in our EBITDA sequentially versus prior year. And so that gives me the conviction to reemphasize what we committed to the street to be EBITDA positive in 2025 and cash flow positive potentially late in 2025 and for sure for the full year of 2026 as we stand right now. Thank you. You all can see why I'm so excited to have Chadi on board. He's been a refreshing partner for me personally, but his ability to execute on a strategy is overwhelming. It's really good. Thank you. Great. Thank you very much. It's very seldom that a Portuguese guy finishes on time, so it's.
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