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spk03: Good afternoon, and welcome to SI Bones' second quarter earnings conference call. At this time, all participants are in listen-only mode. We will be facilitating a question and answer session toward the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Matt Baxo from the Gilmartin Group for a few introductory comments.
spk02: Thank you for participating in today's call. Joining me are Laura Francis, Chief Executive Officer, and Anshul Maheshwari, Chief Financial Officer. Earlier today, SI Bone released financial results for the quarter ended June 30, 2022. A copy of the press release is available on the company's website. Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meeting of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements. These forward-looking statements are based on the company's current expectations and inherently involve risks and uncertainties. These risks include the impact of the COVID-19 pandemic will have on the ability and desire of patients and physicians to undergo and perform procedures using the company's products, the duration of the COVID-19 pandemic, and whether the COVID-19 pandemic will occur in the future. Other forward-looking statements include our examination of operating trends and our future financial expectations, such as expectations for hiring, surgeon training, and adoption, active surgeons, new products, clinical trial enrollment, and reimbursement decisions, and are based upon our current estimates and various assumptions. These statements involve material risks and certainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the risk factors section of our most recent Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. SI Bone disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. This conference call contains time sensitive information and is accurate only as of the live broadcast today, August 8th, 2022. And with that, I'll turn the call over to Laura.
spk00: Thanks, Matt. Good afternoon and thank you for joining us. For today's call, I'll provide a business update and Anshul will provide additional detail regarding our financial results. Before I cover our record second quarter results, let me highlight some recent wins for the company. At the end of May, we received FDA 510K clearance for iFuse Bedrock Granite, our breakthrough product that is intended to provide SI joint fusion in addition to sacral pelvic fixation for adult spinal deformity procedures. This clearance follows the earlier designation by the FDA of iFuse Bedrock Granite as a breakthrough device. In August, CMS published the final decision confirming the new technology add-on payment, or NTAP, of up to $9,828 for eligible cases using iFuse Bedrock Granite. The NTAP will be exclusive to iFuse Bedrock Granite and become effective October 1, 2022, for a period of up to three years. Based on the initial strong surge in reception, we're really excited about the potential for iFuse Bedrock Granite to accelerate our penetration into a highly synergistic $250 million adult deformity market. In mid-June, we received FDA clearance for expanded indications of IFUSE TORQ for pelvic fracture fixation, including acute, non-acute, and non-traumatic pelvic fractures. IFUSE TORQ was previously cleared for both SI joint fusion and fracture fixation. With this expanded clearance, we can now promote the use of IFUSE TORQ for treatment of patients with fragility and insufficiency fractures of the pelvis, which are fractures caused by low-energy traumatic events. We estimate this patient population accounts for $300 million of our $350 million market opportunity. We believe the expanded indication will accelerate our growth in the trauma market as IFUSE TORQ's unique osteointegration features will be an effective option to remobilize patients, many of whom have osteoporosis, who are suffering from fracture-related pain and disability, thereby improving quality of life while simultaneously reducing rehospitalization, which can provide cost savings to the healthcare system. We're confident that the clearance of IFEW's bedrock granite and the expanded trauma indication for IFEW's torque will complement our core market and be catalysts for strong future top-line growth. Now, moving to our performance in the second quarter of 2022. In the second quarter, we generated worldwide revenues of $25.6 million, representing growth of approximately 15% compared to the second quarter of 2021, and 14% growth over the first quarter of 2022. In the U.S., our revenue grew 18% in the quarter compared to a prior year period to a record $23.8 million, which was driven primarily by the robust demand for our procedures. We're pleased with the 23% U.S. procedure volume growth in the quarter, especially when considering that healthcare providers continue to navigate capacity and staffing issues due to the pandemic. We believe that the outpatient nature of our procedure, combined with the solid execution by our dedicated field organization, contributed to the robust volume growth. We exited the quarter with strong operating momentum, with June being the highest procedure volume month in the company's history. Additionally, anecdotal feedback from surgeons suggests that the new patient funnel continues to grow, indicating that we're progressing toward a more normalized operating environment. Now let me provide you an update on our key initiatives as we look to extend our leadership position and drive long-term durable growth. Starting with sales infrastructure, our dedicated sales force remains an important driver of growth as we expand our core market and grow our presence in trauma and adult deformity. Our sales force at the end of the second quarter included 85 territory managers and 76 clinical support specialists. In addition to growing our sales force to ensure high-quality coverage for our surgeons, we remain focused on territory manager productivity. We're confident that with the selective expansion of our sales force and improving territory manager productivity, we'll continue to support our surgeons and deliver strong top-line growth. Moving on to surgeon engagement, we ended the second quarter with a record 720 active surgeons. who performed at least one procedure in the quarter. In addition to surgeon growth, we're also encouraged by the high single-digit increase in surgeon utilization, which reaffirms that our healthcare provider engagement initiatives and our expanded portfolio offering is working. We believe surgeon adoption and improving utilization are strong, positive leading indicators of procedure demand for the rest of 2022 and beyond. Our expanding product portfolio positions us to accelerate surgeon engagement and activation as we progress through the year. We continue to experience a steady increase in adoption rate of surgeons who've been trained on the simulator, which remains a valuable component in our surgeon training programs. Moving forward, we expect to leverage our simulator training along with in-person local training and regional training to drive cost-effective surgeon engagement. We also continue to expand our academic programs to educate residents and fellows. Since inception of the program, we've held training events in approximately 200 academic facilities in the US and trained approximately 1,100 surgical residents and fellows. In the academic year ended June 2022, we trained approximately 500 residents and fellows, demonstrating the growing interest in our products within academic facilities. Additionally, education on bedrock and iFuse bedrock granite are now integral elements to each training. We're encouraged by the steady increase in these previously trained fellows and residents converting to active surgeons as they begin practicing. Turning to products and solutions, we're pleased with the strong performance of iFuse Torque, which delivered record revenue in the quarter. The strong uptake of IFUSE TORC in the last 12 months reaffirms that our portfolio diversification strategy is resonating with our surgeons. With the expanded indication, we're excited about the potential opportunity and trauma for IFUSE TORC to treat sacral fragility and insufficiency fractures, which are currently estimated to have an incidence of approximately 120,000 injuries per year in the U.S., most of which are currently not treated surgically. This fragility fracture market is of strategic importance since over 75% of patients with this condition are initially treated with bed rest and have over a 25% one-year mortality rate. With the indication on label, we've increased our targeted sales and marketing efforts to engage and educate trauma surgeons and believe trauma provides a huge growth opportunity for the company. More to iFuse Bedrock Granite, we're pleased with the strong initial reception for this unique solution that combines the strength of a solid implant with the porosity of 3D printed technology. iFuse Bedrock Granite was developed to address the surgeon's preference to augment stability at the base of long constructs used to treat adult spinal deformity. With an increasing user base of more than 300 surgeons who have performed a Bedrock procedure since 2019, We're optimistic about the adoption of iFuse bedrock granite. We also believe there'll be a subset of surgeons who will want to use some combination of our products to get two points of fixation across the SI joint on either side, resulting in broader portfolio penetration and higher procedure ASP. The differentiated technology, the seamless workflow integration, and the exclusive NTAP for a period of up to three years provides a significant competitive advantage as we expand our presence in the adult deformity market. On the clinical research front, in June we completed enrollment in SILVIA, a two-year prospective international multicenter randomized controlled trial of two different methods for pelvic fixation in adult patients undergoing long-construct spinal fusion. We anticipate the results for the primary endpoint in 2024. Consistent with our focus on clinical evidence and with the expanded IFUS torque indication in place, we're in the process of initiating the SAFROM study, a prospective randomized controlled trial of surgery using our IFUS torque device versus non-surgical management in patients with stable but debilitating sacral fragility or insufficiency fractures. This landmark trial will enroll up to 120 patients at up to 20 sites across the U.S. were targeting enrollment completion by the end of 2023, with early results available in late 2024. Moving to health economics and reimbursement, CMS recently posted the calendar year 2023 proposed rule for hospital outpatient and ASC payments. While preliminary, the current proposal would increase calendar year 2023 facility reimbursement for minimally invasive SI joint fusion procedures performed in ASCs and hospital outpatient settings by approximately 28% and 35% respectively. Today, 80% of our procedures are performed in an outpatient setting or at surgery centers. As our procedures continue to move to ASCs, the potential higher reimbursement in 2023 could serve as a tailwind to demand and also allow us to maintain our pricing in these sites of service. In addition, in June, the American Medical Association posted its decision to add a new category three CPT code, or T-code, to describe SI joint procedures using interpositional products, more commonly referred to as dorsal allograft procedures. The AMA determined that in order to report CPT27279, the code used to describe lateral eye fuse procedures, a transfixing device must be used, additionally, If the implant does not cross the SI joint and the trajectory is different from a lateral or transiliac approach, then the new T-code must be used. As a result, starting January 1, 2023, dorsal allograft procedures, which have no long-term evidence demonstrating durable outcome or radiographic evidence showing fusion, can no longer be reported as 27279 for reimbursement purposes. A recent multicenter retrospective study of 37 patients published in July highlighted that SI joint stabilization involving placement of standalone structural allografts using a dorsal approach has demonstrated complications, including persistent or recurrent postoperative pain, implant malpositioning, structural failures, and lack of joint fusion, further substantiating the AMA T-code division. Talking about our patient awareness initiatives, In the second quarter, we further optimized our direct-to-patient outreach campaign, resulting in higher website traffic, patient engagement, and surgeon referrals. Specifically, our find-a-doctor locator metrics continue to hit new records each month in the second quarter. We view the find-a-doctor metric as a leading indicator of patient engagement and potential future demand. As a reminder, these outreach programs are targeted at patients in chronic severe SI joint pain, who have been in conservative care for an extended period. Our goal is to connect patients with surgeons in their area who perform minimally invasive SI joint procedures using our products. Before I turn it over to Anshul, I'd like to provide an organizational update. In July, Jeff Bertolini joined us as our Senior Vice President of Operations and Technology. Jeff, who was previously at NuVasive as the Vice President of Sales Operations and Logistics, has over 25 years of experience in life sciences and medical device industries. Given our expanding portfolio, Jeff's experience will be invaluable to optimize our supply chain and drive operating efficiencies to ensure we maintain industry-leading growth margins. With that, I'll now turn the call over to Anshul to provide more detail on our financial results.
spk07: Thanks, Laura. Good afternoon, everyone. Our second quarter 2022 total revenue was $25.6 million, representing growth of approximately 15% compared to the prior year period. US revenue was $23.8 million, increasing 18% compared to the prior year period. Growth in the US was driven by strong demand for our solutions, which resulted in a 23% growth in procedure volumes, versus the prior year period. We were encouraged by the steady sequential increase in monthly US procedure volumes as we progressed through the quarter, indicating that the operating environment continues to normalize. Consistent with our experience in the last few quarters, procedure volumes for minimally invasive SI joint fusion at ASCs continued to increase. ASC procedure volumes increased to the low 20% range up from mid-teens in the prior year period. International revenue was $1.8 million, a decline of 8% compared to prior year period, while procedure volume increased by low double-digit percent year-over-year, led by strong performance in France that was more than offset by lower ASP and FX headwinds from weakening of the euro. Gross margin for the second quarter of 2022 was 86%, compared to 89% in the prior year period. The second quarter gross margin was impacted by an anticipated mid-single-digit decline in ASP due to procedure and site of service mix, an increase in cost of operations to support the growth of the business, especially associated with the launch of new products and higher freight costs. Operating expenses increased 22% to $40 million in the second quarter of 2022, as compared to $32.8 million in the prior year period. On a sequential basis, operating expenses grew approximately 10% compared to the first quarter of 2022. The sequential increase was driven by higher commission, increase in travel and freight cost, as well as the timing of our global sales meeting and certain training programs. As we look at the rest of the year, we expect total operating expenses in the second half of 2022 to be low single-digit percentage higher compared to the operating expenses in the first half of 2022. Our net loss was $18.5 million, or $0.54 per diluted share, for the second quarter of 2022 as compared to a net loss of $14 million, or $0.42 per diluted share, in the prior year period. As of the end of the quarter, our cash and marketable securities were approximately $114.4 million, and long-term borrowings were approximately $35.1 million. Our cash outflow in the first half of 2022 included over $8 million in strategic investments to support our facility expansion and build inventory and instrumentaries to ensure the successful launch of IFUSE Bedrock Granite and the expansion of IFUSE Torque. Based on our anticipated investments and Q3 and Q4 operating expenses, we expect cash outflow to moderate in the second half of 2022. Moving to guidance. While we are experiencing strong demand momentum, we remain cognizant of macroeconomic environment and its impact on healthcare. We are currently maintaining our 2022 total revenue guidance of approximately $106 million to $108 million representing growth of 18 to 20% compared to full year 2021. The guidance range reflects strong growth in the U.S., partially offset by foreign currency headwinds in the back half of the year. We also continue to expect gross margin to be in the mid 80% range for fiscal year 2022. With that, I will turn the call over for questions. Operator?
spk03: We will now begin the question and answer session. To ask a question, you may press star then 1 on your touchtone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then 2. At this time, we'll pause momentarily to assemble our roster. Our first question comes from David Saxon from Needham and Company. Please go ahead.
spk06: Hi, Laura and Angela. Thanks for taking the questions and congrats on the quarter. Maybe to start off just on procedure volumes going into the third quarter. I mean, it sounds like June was a really strong month and returning to a more normal operating environment. How should we think about the normal seasonality we typically see in the third quarter? Are you expecting kind of a slowdown? Or do you think we could see some sequential growth just given some of the building momentum with torque, granite, and IFUs?
spk07: David, I can take the question around the cadence for the rest of the year, and thanks so much for the question. You're right, this does feel a lot to us like 2019 was, especially based on the acceleration of growth that we saw in the first half sort of going from, you know, 10% to now 15%. This is worldwide, and the U.S. actually doing even better than that based on the strong procedure volume rebound that we've seen. And you're right. When we think about historical patterns, Q3 tends to be sequentially flat to even lower from Q2. But given the momentum we see in the business, we do expect Q3 to be sequentially up, you know, albeit low single digits up, And there are a couple of factors that play into that. One is just the strong volume in the US that we expect to continue. But some of the staffing challenges that we experienced in Q2, we think some of those will continue to unravel as we progress through the year, especially in Q4, starting to normalize. And then you've got some of the FX challenges that we saw in Q2. We expect some of those to continue in Q3 and Q4 as well. And then as you think about Q4, that That is always the strongest quarter for us from a seasonal perspective as patients have met deductibles and there is an increase in elective procedures in general. So, you know, think about the cadence of sequential growth that we saw in 2019 to sort of be very similar in the Q4 of 2022 when you think about Q3 to Q4 as well.
spk06: Okay. That's super helpful. And then my follow-up is just on OpEx. Appreciate the color you provided in the script. Should we be kind of starting at a mid-80s for the back half in terms of OpEx? And then I guess just, you know, on the increase from the first half to second half, are you pulling forward any investments or is that just, you know, to support the higher revenue? Thanks so much.
spk07: Yeah, so when you think about the first half OPEX, our OPEX was around 75, 76 million. And I'm just talking OPEX, not looking at COGS or anything. And our expectation is a low single-digit percentage increase in the second half versus the first half. If you recall, earlier in the year, we had talked about the productivity in the P&L, especially as we progress through the year, and some of that is going to play out in Q3 and Q4. And then also, there were some spend items that we knew coming into the year that would be more in the first half. We highlighted a few of those specifically around global sales training, certain surgeon and employee training events which don't get replicated in the second half of the year.
spk03: Got it. Thank you. The next question comes from Craig Bajou from Bank of America. Please go ahead.
spk01: Good afternoon, Laura and Anshul. Thanks for taking the question. Let me start with guidance in the second half, or the implied guidance for the second half. I think, by my math, it's about 20% up over the first half, which is Meaningful step up, and I do think year-over-year growth almost doubles what it would be or what it was in the first half. Understand the, you know, encourage what you're seeing, and you're encouraged by what you're seeing in the field. But maybe just a little bit more color on what gives you the confidence in that ramp. And then, you know, additionally, you know, with the torque momentum that you're seeing and the new indications, you know, the launch of granite, Can you just help us think about how or what's driving the higher sales in the second half, whether it's core versus torque versus granite? Obviously, it's going to be all of it, but any color on kind of the magnitude there?
spk00: Yeah, thanks for the question, Craig. And, yeah, we are very bullish about how the business is developing here. seeing the acceleration occurring in the second quarter and a lot of the tailwinds that we discussed on the call earlier today not yet completely in place. And so you're right, it's a little bit of everything. First of all, it's primarily our core business that we're seeing that growth. So as we said, the volume growth was around 23% year over year in the second quarter. in the United States, and that represented 18% growth in revenue, in dollar revenue. And so it is primarily the core business that we're talking about, that we're seeing this rebound in the business, and part of it is from the more normalized environment that we're operating in. But then some of these other factors that we talked about, you know, I think are factors there too. I think Torque has had an impact too in terms of allowing us to convert some competitive accounts with that technology. So primarily it is the core business. And Anshul had mentioned this earlier in his comments where if you think about how the business developed Before COVID hit, we actually saw this same exact sort of acceleration in the core business. And at the time, that was only our IQ3D business. So that's the core. But then on top of it, we have these two additional opportunities that literally just came to fruition in the last month of 2022. And first of all, it is our granite product in adult deformity. And we're very excited about the opportunity that's here. It really is a product that's meeting an unmet clinical need, provides fixation and fusion in spinal pelvic cases for the first time. There's a clear need for it in terms of failures of long constructs with screws loosening and rods breaking, and revisions in over 20% of cases. And we have the technology that addresses this particular issue. We've also been working with over 300 of these surgeons for the last almost three years now. And then we also have the NTAP, which is going to go in place as of October 1st of 2022 for over $9,800. So we do believe that Granite is going to be a significant driver of the business in the second half to aid what's going on with our core business. And then finally, there's the opportunity here in trauma with TORQ. The biggest opportunity in trauma is with these pelvic sacral insufficiency fractures. and fragility fractures, and those just went on label in June of this year, so it gives us the ability to more broadly market these products under that indication, which is another huge opportunity for us as well. So it's all three of those things, core market, adult deformity, and torque, but once again, if you look at how our business developed in 2019 with just the core business, The acceleration that we're talking about is very similar to what you're seeing in our current guidance.
spk01: Got it. Very helpful. Thank you, Laura. Maybe a follow-up for Anshul on OPEX. Appreciate the color that you provided and the thoughts on the second half. And if I could push a little bit on maybe 2023, no, you're not going to provide guidance for that. But how should we think about your ability to see operating leverage kind of going forward? And is it possible, recognizing that you're going to see some of it in the second half, is it possible to see some acceleration in that operating leverage in 23? And, you know, How do some of the inflationary environment or some of those challenges factor into your ability to see that operating leverage in 23 and potentially beyond?
spk07: Yeah, correct. Thanks. You're right, Craig. We're not going to be providing 2023 guidance at this point. But as we think about our business, Craig, and you look at the last 24 months, We've made a significant amount of investment to build out our commercial organization, to build a supporting operating infrastructure. We've continued to invest in R&D. And we've actually built a very solid foundation to be able to deliver this strong, sustainable growth as we come out of the pandemic into a more normalized environment. And, you know, we're getting to a scale now, Craig, you know, we think about it as an inflection point where we're now focused on gaining leverage on that P&L. So as we think about 2023, you're not going to see us not invest in items that we know deliver top-line growth. So R&D, Laura talked about a couple examples of granite and torque and what impact it can have on the business. So R&D will remain a very crucial investment for us in 2023 as well. And then It's going to be a lot of selective addition to our sales force. We've grown our sales force over 30% last year. And as that sales force matures and you combine that with the broader portfolio that allows for deeper surge in engagement and higher utilization, both of them give us confidence in the productivity growing as we get into Q4 and then accelerating into 2023, especially as we look to get to that adjusted EBITDA break-even over time. So I feel really good about the setup that we have, and now it's about monetizing the investments that we've made, Craig.
spk01: Great. Thanks for taking the questions.
spk03: Again, if you have a question, please press star, then 1. Our next question comes from David... Rescott from Truist Securities. Please go ahead.
spk05: Hey, guys. Good afternoon. Thanks for taking the question. I guess first on the reimbursement front, obviously, that's been an extending reimbursement. Reimbursement there has been a tailwind for the business over the past several years. And the, you know, the proposals to increase reimbursement by committing 35% ASD in our basic setting next year is obviously a positive. So I guess first congrats on that. But just wondering how your thinking about that at this point and how, you know, we should be thinking about this meter driving increased utilization, you know, expand the active surgeon base. Just wondering how that improvement next year would impact the business.
spk00: Thanks, David. So, as you said, CMS recently proposed 2023 facility payment increases of 28% and 35% in ASCs and in the hospital outpatient settings. respectively. So the final proposal won't be out until November, so we don't want to speculate on that, but historically the final rulings have not been materially far from the proposal. So that obviously is a significant increase. We think it's going to be significant to surgeons. We think it's going to be significant to hospitals and to surgery centers. In our case, 80% of our procedures are already in surgery centers or hospital outpatient, and so our procedure is already economically attractive at all sites of service. But assuming that the final decision is close to the current proposal, we do think that it's going to be beneficial for facilities that have been dealing with pressures from inflation and from COVID that that is going to be a factor that they'll be considering. And then we think it should be accretive to our revenues as well in terms of demand or also potentially reduced ASP pressures as well at these various sites of service, especially as we continue to see a shift of procedures to ASCs.
spk05: Okay, that's helpful. And I guess sticking on reimbursement, so this new AMA temporary code that's expected to go into place next year, just wondering if that is something that is specific to the iFEWS product versus typical S2AI or SAI2 screws next year, and is there a significant difference in the reimbursement between those two segments, and how does that help you guys into 2023? Yeah.
spk00: So our product, our iFuse product, is a product that is a transfixing product. So the implant is placed by a surgeon. It goes across the joint, and typically three of these implants are placed laterally. And that is how CPT code 27279 is actually described. What the AMA has decided to do is they've decided to create a Category 3 code, not a permanent Category 1 code for, I'm going to just say, commonly referred to as dorsal allograft procedure. So they're taking a posterior approach, not a lateral approach, across the ilium toward the sacrum, across the SI joints. but a posterior approach. And so based on a lack of evidence available for these procedures, as well as many differences from MIS lateral SI joint procedures, which include the placement of a transfixing device like iFuse, they've made this decision to create a category three cold. So we do not sell these dorsal allograft products or procedures. Our iFuse product is a a transfixing lateral approach product. We do expect there will be a significant impact on reimbursement for these other dorsal allograft procedures. We do not believe that commercial payers are going to cover the new T-code in the near term here. We do see this as a significant development.
spk05: Okay, very, very helpful.
spk03: Thanks for the questions.
spk00: Thank you.
spk03: The next question comes from Drew Ranieri from Morgan Stanley. Please go ahead. Hi, thanks for taking the questions.
spk04: Just maybe one on the bedrock and TAP. Just reading through the documents, it looks like CMS might have been expecting like 1,480 cases maybe in the first year. Is that kind of how we should be thinking about the rollout? And Laura and Anshul, I mean, Would you be disappointed if you were only doing that level of bedrock cases over the next 12 months, just given the significance of the product?
spk00: Drew, thanks for the question. And yeah, you definitely read through the Federal Register to get that sort of information. Yes, it's a question as to what the demand will actually be for the product. But if you think about bedrock, what it's trying to do is to address this unmet clinical need that's here, and that's around screws loosening and breakage of rods in approximately 30% of adult deformity cases, and in over 20% of them where revisions are actually required. And our product is a breakthrough from the perspective that it not only provides fixation at the base of the long construct, but fusion as well. And our best estimate here is that this is approximately a $250 million market opportunity that's here. And our best estimate is that there are around 33,000 adult deformity cases that go to the base of the spine in these long construct cases. And so those are the targets for us are those 33,000 cases. And the question is how rapidly can we capture that market opportunity? And as I said earlier, we do have a head start on this because of our original bedrock technique where surgeons were using our iFuse 3D product at the base of the long construct and have already worked with over 300 of these surgeons with these procedures. So they're familiar with it. Granite is really a very significant change here that it integrates with the long construct. and it has all of these benefits associated with it, including the economic benefits of the NTAP.
spk04: Thank you, Laura. Maybe just kind of thinking about R&D for a moment and just hearing Anshul's comments that you're going to continue to spend into next year on R&D. You just got a new indication for TORIC. You have bedrock, granite, and the NTAP. Just curious kind of what's next in the product portfolio as you're kind of shifting maybe more of the portfolio to drama. Any additional products that we should be thinking about in the back half of the year into 2023? Thank you.
spk00: Thanks, Drew. So we're not talking about future launches. As you know, we're pretty tight to the vest on those sorts of things. announcements, but what I will say is that we are a sacropelvic surgical solutions company, and what we've done is really identified a space that was not well served by other companies in this space, and we have become the expert in the sacropelvic space. So it all started out with our core product, our iFuse product, and iFuse 3D targeting minimally invasive SI joint fusion. Then with our launch of TORC around a year ago, also targeting the core market, but trauma as well. And then the new indication over the last few weeks really opens up that pelvic ring fracture market for us. And now with the Granite launch focusing on adult deformity. So what you can expect to see is for us to continue to, first of all, first and foremost, focus on the development of our core market. There's a multi-billion dollar market opportunity there. We have a very strong position. We're the clear market leader in this space. Our best estimate is that we have close to 70% market share in our core market. But we are diversifying our products and our business as well through TORQ and Granit by capturing more of this opportunity in sacral pelvic surgical solutions. So that's really the focus for our business. You can see that it's an innovative product that's differentiated and putting us in a position of addressing unmet clinical needs where others have not.
spk03: Again, if you have a question, please press star, then one. That's star, then one. The next question comes from Dave Turkoli from JMP Securities. Please go ahead.
spk08: Great, thanks. Laura, maybe as we're looking at product differentiation, obviously the original iFuse 3D was a lot different than other things out there, but some competitors... did launch products that arguably are not of the same caliber without the data. But when you look at Torque and Bedrock, I'd just love to get your thoughts sort of on IP protection and sort of competitors' responses. Is anyone else sort of looking at these opportunities and maybe coming with products they already have approved, or are you aware of anyone else sort of maybe tweaking what they have today to potentially come at some of these opportunities as well? Or do you feel like you're really the game in town? Thank you.
spk00: Thank you. David, it's a good question that you're asking. And as I said, as a response to the last question, we really are all about the differentiation of our products, protecting them with patents, In addition, having the most clinical data on these products and conditions that we can. So now over 100 peer-reviewed published papers at this point on our various products, techniques, biomechanics, economics, and so on. And so we're differentiating ourselves through product, patent, clinical data, education, sales force, and we really are unique in the industry from this perspective. There are others that are certainly trying to follow us into these areas, but in each case what we do is we've built a lot of moats around our businesses. You know, in the case of iFuse 3D, the clinical data, the exclusive reimbursement, the patents that we have, you know, in the case of Granite that we just talked about, the product itself, the breakthrough device designation, the NTAP that's out there. And, you know, if you look at the results of what we've done, we have seen our market share grow from the time that we became a public company where we were in the mid 50s to now approaching approximately 70%. So it really does tell you that we are developing strategies that are winning in the marketplace. And so our goal now is not so much to be capturing more market share. Our goal is to grow the market overall in our core business and then to exploit the markets in adult deformity fixation and fusion, as well as with fragility fractures in trauma. These areas are unmet clinical needs that we are addressing with unique products and with a lot of data and education to support our positions.
spk03: Great. Thank you.
spk00: Okay.
spk03: There are no more questions in the queue. This concludes our question and answer session. I'd like to turn the conference back over to Laura Francis for any closing remarks.
spk00: Thank you, and thanks to all of you for joining us on the call today. As I've talked about, we have several tailwinds that we believe are going to accelerate our revenue growth over the next 18 months, and that includes our increasingly productive sales force, our new product launches, a favorable reimbursement landscape, and indication expansions into attractive new markets. We look forward to seeing you all at the upcoming Canaccord Conference in Boston, the Morgan Stanley Conference in New York, as well as the Needham Virtual Conference. Thanks again and goodbye.
spk03: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
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