SI-BONE, Inc. (SIBN)
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Earnings Call: Q2 2022

Aug 8, 2022

Operator

Good afternoon, and welcome to SI-BONE's Q2 Earnings Conference Call. At this time, all participants are in listen-only mode. We will be facilitating a Q&A 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 Bacso from the Gilmartin Group for a few introductory comments.

Matt Bacso
Managing Director, Gilmartin Group

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 30th, 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 meaning 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 uncertainties 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. With that, I'll turn the call over to Laura.

Laura Francis
CEO, SI-BONE

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 Q2 results, let me highlight some recent wins for the company. At the end of May, we received FDA 510(k) clearance for iFuse Bedrock Granite, our breakthrough product that is intended to provide SI joint fusion in addition to sacropelvic 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 1st, 2022, for a period of up to three years. Based on the initial strong surgeon 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 osseointegration features will be 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 iFuse Bedrock Granite and the expanded trauma indication for iFuse TORQ will complement our core market and be catalysts for strong future top-line growth. Now moving to our performance in the Q2 of 2022. In the Q2, we generated worldwide revenues of $25.6 million, representing growth of approximately 15% compared to the Q2 of 2021 and 14% growth over the Q1 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 Q2 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 Q2 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 U.S. 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 TORQ, which delivered record revenue in the quarter. The strong uptake of iFuse TORQ 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 in trauma for iFuse TORQ 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. Moving 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 iFuse TORQ indication in place, we're in the process of initiating the SAFFRON study, a prospective randomized controlled trial of surgery using our iFuse TORQ device versus nonsurgical 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. We're 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 III 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 CPT 27279, the code used to describe lateral iFuse 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 1st, 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 stand-alone structural allograft 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 decision.

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 continued 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 the 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.

Anshul Maheshwari
CFO, SI-BONE

Thanks, Laura. Good afternoon, everyone. Our Q2 2022 total revenue was $25.6 million, representing growth of approximately 15% compared to the prior year period. U.S. revenue was $23.8 million, increasing 18% compared to the prior year period. Growth in the U.S. 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 U.S. 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 % 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 Q2 of 2022 was 86%, compared to 89% in the prior year period. The Q2 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 cost. Operating expenses increased 22% to $40 million in the Q2 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 Q1 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 Q2 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 instrument trays to ensure the successful launch of iFuse Bedrock Granite and the expansion of iFuse TORQ. 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?

Operator

We will now begin the Q&A session. To ask a question, you may press star, then one 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 two. At this time, we'll pause momentarily to assemble our roster. Our first question comes from David Saxon from Needham & Company. Please go ahead.

David Saxon
Managing Director, Needham & Company

Hi, Laura and Anshul. Thanks for taking the questions and congrats on the quarter. Maybe to start off just on procedure volumes going into the Q3 . 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 Q3 ? Are you expecting kind of a slowdown, or do you think we could see some sequential growth just given some of the, you know, building momentum with TORQ, Granite, and iFuse?

Anshul Maheshwari
CFO, SI-BONE

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. You're right, when we think about historical patterns, Q3 tends to be sequentially flat to even lower from Q2. Given the momentum we see in the business, we do expect Q3 to be sequentially up, you know, albeit low single digits up. There are a couple of factors that play into that.

One is just the strong volume in the U.S. that we expect to continue. 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. Then you've got some of the FX challenges that we saw in Q2. You know, we expect some of those to continue in Q3 and Q4 as well. Then as you think about Q4, 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.

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.

David Saxon
Managing Director, Needham & Company

Okay, that's super helpful. My follow-up is just on OpEx. Appreciate the color you provided in the script. Should we be kinda starting at a mid-80s for the back half in terms of OpEx? 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.

Anshul Maheshwari
CFO, SI-BONE

When you think about the first half OpEx, our OpEx was around $75million to $76 million, and I'm just talking OpEx, not looking at, you know, COGS or anything. Our expectation is a low single-digit % increase in the second half versus the first half. You know, if you recall, you know, 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 gonna 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.

David Saxon
Managing Director, Needham & Company

Got it. Thank you.

Operator

The next question comes from Craig Bijou from Bank of America. Please go ahead.

Craig Bijou
Senior Equity Research Analyst, Bank of America Securities

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, you know, 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. I understand you're encouraged by what you're seeing in the field. Maybe just a little bit more color on what gives you the confidence in that ramp.

You know, additionally, you know, with the TORQ 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? You know, whether it's core versus TORQ versus Granite. Obviously, it's gonna be all of it, but any color on kind of the magnitude there.

Laura Francis
CEO, SI-BONE

Yeah. Thanks for the question, Craig. Yeah, we are very bullish about how the business is developing here, seeing the acceleration occurring in the Q2 and a lot of the tailwinds that we discussed on the call earlier today, not yet completely in place. 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 Q2 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. Part of it is from the more normalized environment that we're operating in.

Some of these other factors that we talked about, you know, I think are factors there too. I think TORQ has had an impact too in terms of allowing us to convert some competitive accounts with that technology. Primarily it is the core business. Anshul had mentioned this earlier in his comments, where if you think about how the business developed before COVID-19 hit, we actually saw this same exact sort of acceleration in the core business, and at the time, that was only our iFuse 3D business. That's the core. On top of it, we have these two additional opportunities that literally just came to fruition in the last month of 2022.

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 sacropelvic cases for the first time. There's a clear need for it in terms of failures of long constructs with screws loosening, rods breaking, and revisions in over 20% of cases. 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. We also have the NTAP, which is going to go in place as of October 1st of 2022 for over $9,800.

We do believe that Granite is gonna be a significant driver of the business in the second half to aid what's going on with our core business. 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. It gives us the ability to more broadly market these products under that indication, which is another huge opportunity for us as well. It's all three of those things, core market, adult deformity, and TORQ.

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.

Craig Bijou
Senior Equity Research Analyst, Bank of America Securities

Got it. Very helpful. Thank you, Laura. Maybe a follow-up for Anshul on OpEx. Appreciate the color that you provided and, you know, the thoughts on the second half. If I could push a little bit on maybe 2023, you know, you're not gonna provide guidance for that, but how should we think about your ability to see operating leverage kinda going forward? You know, is it possible, recognizing that you're gonna see some of it in the second half, is it possible to see some acceleration in that operating leverage in 2023? You know, how do some of the inflationary environment or some of those challenges factor into your ability to see that operating leverage in 2023 and, you know, potentially beyond?

Anshul Maheshwari
CFO, SI-BONE

Yeah. Craig, thanks. You are right, Craig. We're now not gonna be providing 2023 guidance at this point. You know, as we think about our business, Craig, and you know, 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. 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. 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.

As we think about 2023, you're not gonna see us not invest in items that we know deliver top line growth. R&D, Laura talked about a couple examples of Granite and TORQ and what impact it can have on the business. R&D will remain a very crucial investment for us in 2023 as well. It's gonna be a lot of selective addition to our sales force. You know, we've grown our sales force over 30% last year. As that sales force matures, and you combine that with the broader portfolio that allows for deeper surgeon 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 breakeven over time.

Feel really good about the setup that we have, and now it's about monetizing the investments that we've made, Craig.

Craig Bijou
Senior Equity Research Analyst, Bank of America Securities

Great. Thanks for taking the questions.

Operator

Again, if you have a question, please press star then one. Our next question comes from David Rescott from Truist Securities. Please go ahead.

David Rescott
Equity Research Analyst, Truist Securities

Hey, guys. Good afternoon. Thanks for taking the questions. I guess first on the reimbursement front, obviously that's been a tailwind for the business over the past several years. You know, the proposals to increase reimbursement by 28% and 35% in ASC outpatient setting next year is obviously a positive. I guess first congrats on that. Just wondering how you're thinking about that at this point and how you know we should be thinking about this matter driving increased utilization, you know, expanding the active surgeon base. Just wondering how that improvement next year would impact the business.

Laura Francis
CEO, SI-BONE

Thanks, David. As you said, CMS recently proposed 2023 facility payment increases of 28% and 35% in ASCs and in the hospital outpatient setting respectively. The final proposal won't be out until November, so we don't wanna speculate on that. Historically, the final rulings have not been materially far from the proposal. 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. Our procedure is already economically attractive at all sites of service.

You know, assuming that the final decision is close to the current proposal, we do think that it's gonna be beneficial for facilities that have been dealing with pressures from inflation and from COVID, that is going to be a factor that they'll be considering. 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.

David Rescott
Equity Research Analyst, Truist Securities

Okay. That's helpful. I guess sticking on reimbursement, so this new AMA temporary code that is expected to go into place next year, just wondering if that is something that is specific to the iFuse product versus typical S2AI or S2AI 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?

Laura Francis
CEO, SI-BONE

Yeah. You know, our product, our iFuse product, is a product that is a transfixing product. The implant is placed by a surgeon. It goes across the joint, and typically three of these implants are placed laterally. That is how CPT code 27279 is actually described. What the AMA has decided to do is they've decided to create a Category III code, not a permanent Category I code, for, I'm gonna just say, commonly referred to as dorsal allograft procedure. They're taking a posterior approach, not a lateral approach across the ilium toward the sacrum, across the SI joint, but a posterior approach.

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 III code. We do not sell these dorsal allograft products or procedures. Our iFuse product is a transfixing lateral approach product. You know, we do expect there'll be a significant impact on reimbursement for these other dorsal allograft procedures. We do not believe that commercial payers are gonna cover, you know, the new T code in the near term here. We do see this as a significant development.

David Rescott
Equity Research Analyst, Truist Securities

Okay. Very, very helpful. Thanks. Grade the questions.

Laura Francis
CEO, SI-BONE

Thank you.

Operator

The next question comes from Drew Ranieri from Morgan Stanley. Please go ahead.

Drew Ranieri
VP of Medical Technology Equity Research, Morgan Stanley

Hi. Thanks for taking the questions. Just maybe one on the Bedrock NTAP. 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? 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?

Laura Francis
CEO, SI-BONE

Drew, thanks for the question. You definitely read through the Federal Register to get that sort of information. Yes, you know, it's a question as to, you know, what the demand will actually be for the product. You know, if you think about Bedrock, it's 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. Our product is a breakthrough from the perspective that it not only provides fixation at the base of a long construct, but fusion as well.

You know, our best estimate here is that this is approximately a $250 million market opportunity that's here. Our best estimate is that there are around 33,000 adult deformity cases that go to the base of the long construct, the base of the spine, in these long construct cases. Those are the targets for us, those 33,000 cases. The question is how rapidly can we capture that market opportunity? 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.

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.

Drew Ranieri
VP of Medical Technology Equity Research, Morgan Stanley

Great. Thank you, Laura. Maybe just kind of thinking about R&D for a moment and just hearing Anshul's comments that you're gonna continue to spend into next year on R&D. You just got a new indication for iFuse TORQ. You have iFuse 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 trauma. Any additional products that we should be thinking about in the back half of the year into 2023? Thank you.

Laura Francis
CEO, SI-BONE

Thanks, Drew. You know, we're not talking about future launches. As you know, we are pretty close to the vest on those sorts of announcements. What I will say is that we are a sacropelvic surgical solutions company. What we've done is really identified a space that was not served by other companies in this space, and we have become the expert in the sacropelvic space. It all started out with our core product, our iFuse product, and iFuse 3D targeting minimally invasive SI joint fusion. With our launch of TORQ around a year ago, also targeting the core market, but trauma as well, and the new indication over the last few weeks really opens up that pelvic ring fracture market for us.

Now with the Granite launch focusing on adult deformity. 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 Granite by capturing more of this opportunity in sacropelvic surgical solutions. That's really the focus for our business. You can see that this is innovative product that's differentiated and putting us in a position of addressing unmet clinical needs where others have not.

Operator

Again, if you have a question, please press star then one. That's star then one. The next question comes from Dave Turkaly from JMP Securities. Please go ahead.

David Turkaly
Managing Director and Senior Equity Research Analyst, JMP Securities

Great, thanks. Laura, you know, maybe as we're looking at, you know, product differentiation, obviously, the original iFuse 3D was a lot different than other things out there. You know, some competitors did launch products that arguably are, you know, not of the same caliber without the data. When you look at, you know, TORQ and Bedrock, I'd just love to get your thoughts sort of on IP protection and then sort of competitors' responses. Is anyone else sort of looking at these opportunities and, you know, maybe coming with, you know, 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? Do you feel like you're really the game in town? Thank you.

Laura Francis
CEO, SI-BONE

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. Now over 100 peer-reviewed published papers at this point on our various products, techniques, biomechanics, economics, and so on. We're differentiating ourselves through product, patent, clinical data, education, sales force. 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. 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%. It really does tell you that we are developing strategies that are winning in the marketplace.

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.

David Turkaly
Managing Director and Senior Equity Research Analyst, JMP Securities

Great. Thank you.

Laura Francis
CEO, SI-BONE

Okay.

Operator

There are no more questions in the queue. This concludes our Q&A session. I would like to turn the Conference back over to Laura Francis for any closing remarks.

Laura Francis
CEO, SI-BONE

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 gonna 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 Genuity Annual Growth Conference in Boston, the Morgan Stanley Conference in New York, as well as the Needham Virtual Growth Conference. Thanks again, and goodbye.

Operator

The Conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

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