Good morning, everyone. Thanks for coming to day two of the Jefferies London Healthcare Conference. My name is Young Li, one of the U.S. MedTech analysts. Pleased to be joined by management from SI-BONE, Laura Francis, CEO, and Anshul Maheshwari, CFO. This will be a moderated Q&A session. Laura and Anshul, thanks for coming, and welcome to our conference.
Thank you.
Thanks for having us.
All right, great. I guess to start, you know, given that we have more of an international audience, who might not be as familiar with the company, why don't we start a little bit high level before digging in, and maybe just ask Laura and Anshul to introduce the company briefly and, talk a little bit about, SI-BONE's differentiation and how you're able to take 70+ market share in your core SI joint fusion market.
Thanks, Young, and thank you for the invite. It's wonderful to be here in London, and thank you for attending as well. So, I'm Laura Francis. I'm the Chief Executive Officer of SI-BONE. The company started approximately 15 years ago at this point, and I joined almost nine years ago, so I've been on this journey for a good portion of the history. But the way that the company started was the founders were my predecessor, Jeff Dunn, who was the former CEO of the company. I became the CEO 2.5 years ago. But Jeff is now our Chairman of the Board, and he and Dr. Mark Reiley started the company 15 years ago, and they had already worked with one another at two other businesses.
The most recent business that they had invested in was a company called InBone, I-N-B-O-N-E, and it was an ankle replacement company. That company was bought by Wright Medical, and it now is part of the Stryker portfolio and has over 70% market share in the ankle replacement market as well. So Jeff and Dr. Reiley have been known as serial entrepreneurs in MedTech. Dr. Reiley was also known as one of the founders of Kyphon. He developed kyphoplasty, so this was a very seasoned entrepreneurial team that started the business. The brainchild for SI-BONE was, if you look at all of the joints in the human body, the SI joint, or joints, are the largest joints in the human body. So you have two SI joints in your pelvis.
They carry the weight from your upper body to your lower body. They help you to twist and bend, and they move in multiple directions. They nutate just a few millimeters. It's not like a knee or a shoulder, where there's very significant flexion, but there's enough movement in this joint that if it degenerates or if it becomes disrupted, it can cause anywhere from mild to excruciating pain for an individual. When Dr. Reiley looked at the SI joint, it was the only joint in the human body that did not have a surgical solution. What he did is developed that solution. Given the biomechanics of the joint, he created a triangular implant.
The goal was to use a lateral technique, so lateral going across the hip toward the sacrum, in order to stabilize the joint with three triangular implants and ultimately to fuse that particular joint. So what we've learned over the years is this is a highly effective procedure for those patients who have debilitating pain. We have very significant clinical data, over 120 peer-reviewed, published papers at this point, that show the safety, the efficacy of the product, the biomechanical nature of the joint, the health economics of the joint. The biggest challenge when I came in was reimbursement, because for a company that is developing a completely new solution, you don't have insurance coverage, especially in the United States. We have also been in Europe for over 10 years at this point.
So, we started out actually in northern Italy, believe it or not, but then moved to Germany. We have operations here in the U.K. and most recently added France as well, and we have exclusive coverage in France for SI joint technology. And we actually have a nice specific recommendation for our technology here in the U.K.. So we are a global company. We pride ourselves on that. And since we started, we've expanded into a number of different areas, and I'm sure Young is going to ask me about. We've moved from being what I would call the triangle company or the SI joint company, to more of a sacropelvic solutions company.
In the last couple of years, we've launched products in the trauma space for pelvic ring fractures, and then also for pelvic fixation to be used in combination with long constructs in adult deformity or scoliosis patients, and then also in short constructs and degenerative procedures. I'll stop there. That gives you, I hope, a flavor for the history of the company, as well as what we're trying to accomplish. We've really become the leader here. We identify unmet clinical needs. We develop innovative products. We use an educational approach so the surgeons understand the conditions and how to perform these procedures. We support our surgeons from a reimbursement perspective, and all of our businesses and our products are grounded in high-quality clinical data.
All right, great. That's a very good overview. I guess, one more high-level question, and then we can drill down to the details. But we're asking most of our companies about this, can't really escape the topic, but the potential GLP impacts to SI-BONE's business and core markets. I guess, are there any near-term impacts to numbers or long-term impacts to your TAM? Maybe talk a little bit about the typical SI-BONE patient. You know, what's their BMI, BMI levels? What causes their disease?
Thank you. Yeah, I think we all have to ask, answer this GLP-1 question. Initially, when it started to come up, it wasn't something that I paid very close attention to because musculoskeletal issues are usually a result of something other than obesity. But, the good news on this is that we actually do have a lot of data on the disease states that our surgeons are treating that allows us to give fairly detailed answers on this particular question. So I'll go back to the SI joint. The typical patient for us is a 50-year-old female. So it is... And typically, she has had at least one child, and in most cases, multiple children. As you can imagine, this joint, these two joints are in your pelvis.
And so the joint will become degenerated over time, but it also can be disrupted by traumatic events, and I'm going to include pregnancy and childbirth in that category of trauma. So 2/3 of our patients are female, and it's actually a younger population as well, that we typically see as a patient. As I said, we have a lot of clinical data, including two randomized controlled trials that go out beyond five years, that show the efficacy of the procedure. The typical patient in terms of BMI is between 28 and 29, which here in Europe may sound like a higher BMI. In the United States, that's a more typical BMI. And so we have not seen any connection between obesity and the SI joint, as I said.
Female patients, some age-related factors, trauma are more of the issue that we see versus weight-related issues. We've also had conversations with our surgeons on this topic too, which initially they will just dismiss this question altogether. But if you really push them, the typical response that we get is that particularly large patients typically are not operated on with some sort of a joint procedure. It is very typical for a surgeon that has a patient that is a high BMI patient to tell them, "You need to go home. You need to lose weight. You need to stop smoking," because any surgeon is going to want the patients to have a good outcome.
Those patients that are morbidly obese typically are not going to have a good outcome with any joint surgery, including an SI joint procedure. Our surgeons, over time, actually believe that GLP-1s, assuming that they're safe and effective over the long term, will actually increase the number of patients that they see, because as patients age, as they become more active, you actually see more of those patients that have degeneration in their joints, and they're going to be more likely to actually perform procedures on those particular patients.
All right, great. That's very helpful. Yeah, I think the market is starting to understand those dynamics as well. So I guess maybe just shifting over to the business, maybe just on the top line, since first quarter of last year, you were able to really accelerate the top-line growth, for you know, many quarters in a row. Now you're hitting a little bit of tough comps, but you know, you are still growing 30% in the past two quarters. Maybe you can talk a little bit about the key growth drivers for the improved performance, how we should think about the sustainability of that, and you know, is SI-BONE a sustainable 20+% grower?
Yep. Thank you. We're really excited about where we're at as a company, and we've actually grown over 30% over the last four quarters at this point in terms of our volumes, and also if you look at our business in the United States as well. You know, as I'm sure you all can appreciate, we were not in a normalized environment during the pandemic. But what we did was we invested pretty significantly during the pandemic in order to come out as strong as we have come out.
In terms of what's driving the growth of the business, our core business is a very large market opportunity, and it's over 200,000 procedures, and this is just in the United States, that we estimate as the potential market for SI joint fusion, specifically. As Young stated, we are the leader in this space. Our estimate is that we have over 70% market share in this particular space because of all of the benefits of the technology that I mentioned to you. And so that core business, we've seen a re-acceleration of that business, and part of it is just getting to a certain level of maturity in the business. We have the best sales force in the industry.
Most of our sales are direct sales because this is an educational sale, educating on the condition and on the clinical data. And so we've grown a mature sales force that has come out of the pandemic performing very strongly in order to re-accelerate that core business. In addition, I mentioned that we've expanded the business in the last couple of years. We launched a product in 2021 called TORQ, and that product is used; it is used in primary SI joint fusion, but it's also used in pelvic ring fractures. So these are traumatic events and specifically fragility fractures. So these are typically patients that are much older patients, poor bone quality, and they may have a fall, or they may get even just jostled in a car, or...
They will incur what are called fragility fractures. Similar to when we initially started our SI joint business, this is a condition that typically is not treated. It's treated conservatively, so it's medications, it's physical therapy. Given the age of the patients, it's typically rehabilitation, where a patient is taken care of at a rehab site because many of them can't get up and move around. They're not mobile. So that was a focus for us with our launch of our Torque product. We've also started a randomized controlled trial called SAFFRON to show the safety and efficacy of that particular procedure in order to encourage more surgeons to perform surgery here versus just rehab for these patients.
Finally, in 2022, we launched a product called Granite, and that product is for pelvic fixation. There are over 100,000 cases for long constructs and short constructs where we are basically trying to ensure the veracity of a long construct in a patient. If you think about an S-shaped spine, a surgeon is typically using pedicle screws and rods in order to straighten the spine. In approximately 25% of those cases, you have fixation failure, meaning that screws come loose or rod breaks. And as you can imagine, this is a very expensive procedure. It is a very invasive procedure. So what we did is we're not developing pedicle screws and rods. We developed only the pelvic fixation products in these particular cases. We received a breakthrough device designation from the FDA in the United States.
We have a new technology add-on payment that we received as well. It is approximately $9,800 for the surgeon and the hospital to perform this procedure. Our goal is to significantly reduce those revisions as well. What we'd like to see with this product and where we believe we're going is to become the standard of care in long construct procedures, but also in shorter procedures as well, short constructs, lumbar fusion-type procedures, with certain patients. In fact, over 40% of our Granite sales have been in these short constructs, which is a significant market opportunity, too.
So Young, to kind of wrap it up, it's been a combination of our core business re-accelerating out of the pandemic, plus two new markets that we've entered, and in all three of these cases, identifying unmet clinical needs, using clinical data, and ensuring that there's appropriate reimbursement for these procedures as well.
Okay, great. That's very helpful. And, you know, clearly you have proven that you can launch innovative products successfully, so that's great. I guess just to maybe to follow up, just given the success of Granite and, you know, your TAM expansion there, you're planning to launch a new product or line extension in the Granite family, targeting the shorter construct procedures, which is a you know, larger TAM, more procedure opportunity. I guess, you know, what do you need before approval and launch of the product? How should we think about revenue contributions and cross-selling opportunities?
So I touched on this a little bit when I spoke about Granite, and I mentioned over 100,000 procedures as the TAM. If I break that down a little bit, and I talked about long constructs in scoliosis cases, there's in total around 130,000 cases here in the United States. That's the opportunity that we have. Of that opportunity, 30,000 of those cases are in long constructs. As I said, what we believe is that we're just going to become the standard of care there, and in those 30,000 cases, we believe that they're going to wanna use pelvic fixation. They're going to wanna use Granite because Granite not only provides fixation, but it also provides fusion and should address some of these issues that I mentioned with fixation failure.
The other 100,000 of this are short construct cases, and our original Granite product was targeting the 30,000, not the 100,000. What we realized as we were working with surgeons is they were using Granite in these short construct cases for patients that they believed needed pelvic fixation at the bottom of a short construct procedure, which is basically a two to four level construct that goes down to the sacrum. And so what we have discussed publicly is that we are going to launch a new product that is specifically targeted toward these short construct cases and the 100,000 additional cases, in the United States, that go down to the sacrum as well. So in terms of our timing, we have said that we would have a product available in 2024.
We haven't given much more data to this point than that, but we believe that this new product is going to open up that additional 100,000 patient opportunity per year in the United States. Currently, we have not launched either our Torque product or our Granite product here in the EU. However, we are going through the EU MDR process, first with our Torque product, and we will launch here in Europe as well.
All right, great. That's gonna be an exciting growth driver for next year, I'm sure. Maybe shifting over to the P&L a little bit. Maybe a question to Anshul. Just, you know, when we think about sources of leverage, rep productivity is one of the key drivers. I think they're currently doing around $1.5 million, trailing twelve months, and you expect them to get to maybe up to around $2 million range. I guess, you know, do you have sufficient coverage with your existing sales channel, the direct sales reps? Are there plans to add more reps or promote more of the junior reps in order to take advantage of some of the growth opportunities going forward?
Thanks, Young, for the question. So as Laura said, we've got one of the best commercial sales forces in the industry, and we made significant investment to build that out throughout the pandemic, and that was in anticipation of the growth that we're seeing in the business today. Like Laura said, you know, last four quarters, more than 30% volume growth in the U.S. So we're really pleased with the productivity we are seeing, how that's translating into Adjusted EBITDA improvements on a year-over-year basis. Year-to-date, we've seen our Adjusted EBITDA improve 57%. Now, when you think about, you know, what's driving that productivity, I'd say there are about four things that drive that. One is just the quality and the maturity of our sales force.
And when you complement that with some of the hybrid models that we're working on, which is including junior reps, for case coverage or case support, identifying agents, especially in the deformity space, to provide case support, and then also placing instrument trays and implants at high volume sites. The intent is to create more bandwidth for the reps, our territory managers, to build deeper dialogue with surgeons, and also engage newer surgeons. That model's worked really well for us. When we started a few years ago, talking about the stats, we were hoping to get between $1.5 million-$2 million per territory, as you said, Young. This year, our trailing twelve months, as of the third quarter, was about $1.5 million per territory.
That's grown from $1 million two years ago, so really good progress there. Our focus now is to selectively add people to the sales force as we go into next year, but focus on how we get the territories to that higher end of the $1.5 million-$2 million. So we have room there to continue to drive growth and productivity, and we plan to do that with junior resources, the hybrid model, and also with consignment and parking of trays.
All right. Great. Excellent. I guess maybe just to follow up on OpEx leverage and profitability. So, OpEx growth has been around mid-single digits, and currently, your EBITDA levels is around, you know, negative, low double-digit percentage. You know, how should we think about the pathway to EBITDA breakeven? And then if you deliver upside to revenues, how much gets dropped through, and what gets reinvested for growth and pipeline products?
Yeah, and thanks for that question again, Young. From an operating leverage perspective, what you've seen is our operating leverage has been quite linear to our revenue growth over the last several quarters. And what we've demonstrated is, as we've made those investments over the last three years, and we've put more capacity in the field from an instrument tray and implant perspective, we've seen significant amount of those dollars fall to the bottom line. You know, we're fortunate to have high 70% gross margins, so we can afford to make those investments.
The productivity you're seeing at the sales level, the scaling of the SG&A that you're seeing, we feel really good about the 57% year-to-date reduction in Adjusted EBITDA, but also the trajectory that we're on and our expectation that revenue growth will continue to outpace OpEx growth as we go into the future, and remain very committed and focused on getting to that Adjusted EBITDA breakeven.
Okay, great. Think we are right on time, so I'll just end it here. Thank you so much, Laura and Anshul, for this very interesting session.
Thanks, Young.
Thanks so much.
Thank you all.