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Earnings call: Treace Medical sees steady growth and plans new products

EditorNatashya Angelica
Published 2024-08-07, 11:38 a/m
© Reuters.
TMCI
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Treace Medical Concepts Inc. (TMCI), a leader in the foot and ankle medical device market, reported a revenue increase in its second quarter earnings call. The company announced a 6% revenue growth to $44.5 million, driven by an expanded active surgeon base and increased adoption of its innovative products like SpeedPlate and Adductoplasty.

Despite a competitive market and facing headwinds from knockoff versions of their flagship Lapiplasty product, Treace Medical reaffirmed its full-year 2024 revenue guidance of $201 million to $211 million. The company also expects a significant improvement in adjusted EBITDA and remains focused on expanding its product portfolio and customer base.

Key Takeaways

  • Treace Medical reported a 6% increase in Q2 revenue year-over-year, amounting to $44.5 million.
  • The company anticipates a 50% improvement in adjusted EBITDA for the full year.
  • Plans are in place to launch two new minimally invasive osteotomy solutions in Q4 2024.
  • Gross margin slightly decreased to 80.2% due to changes in product mix and higher costs.
  • Operating expenses rose to $57.1 million, reflecting investment in innovation and commercial initiatives.
  • Net loss for common stockholders widened to $21.3 million from $12.4 million the previous year.
  • The company is optimistic about the potential for reimbursement rate increases in 2025.
  • There are 10 new products in the pipeline set to launch through 2025.

Company Outlook

  • Full-year 2024 revenue guidance remains at $201 million to $211 million.
  • A positive EBITDA is anticipated for 2022.
  • Growth expected in the second half of the year despite current market softness.

Bearish Highlights

  • The market for foot and ankle procedures has shown some softness.
  • Gross margin has decreased slightly due to a change in product mix and increased costs of goods sold.
  • Net loss attributable to common stockholders increased compared to the same period last year.

Bullish Highlights

  • Continued growth driven by an increase in active surgeons and case volumes.
  • New product launches aim to expand the company's footprint in the minimally invasive osteotomy market.
  • Proposed reimbursement rate increases for 2025 could expand access to Treace Medical's products.

Misses

  • No plan to raise prices currently, despite the increased costs of goods sold.
  • The limited market release of the new MIS osteotomy product in Q4 is not expected to have a material financial impact.

Q&A Highlights

  • Executives addressed concerns about competition from knockoff products and reaffirmed profitability guidance.
  • The company discussed its diverse portfolio of fixation offerings to meet varying surgeon needs and settings.
  • There is an anticipation of higher reimbursement rates from commercial payers compared to CMS.

Treace Medical Concepts Inc. continues to navigate a competitive landscape with a strategic focus on innovation and market expansion. The company's robust pipeline and commitment to product development, along with positive industry trends, position it to potentially capitalize on future market opportunities. Investors and stakeholders are expected to watch closely as Treace Medical moves towards the launch of its new products and seeks to improve its financial metrics in the coming quarters.

InvestingPro Insights

Treace Medical Concepts Inc.'s (TMCI) latest earnings report reflects a company in the midst of growth, even as it navigates the complexities of the competitive medical device market. In light of this, InvestingPro provides several insights that may be relevant to investors evaluating the company's financial health and future prospects.

InvestingPro Data highlights a revenue growth of 18.9% over the last twelve months as of Q2 2024, indicating a solid increase that aligns with the company's reported expansion. The gross profit margin remains high at 80.67%, showcasing the company's ability to maintain profitability on its products. However, the adjusted P/E ratio of -5.96 suggests that the market is valuing the company with anticipation of future earnings rather than current profitability.

InvestingPro Tips reveal that while analysts have revised their earnings upwards for TMCI, reflecting optimism about the company's performance, they do not anticipate Treace Medical will be profitable this year. This is consistent with the company's own report of a net loss for common stockholders. Additionally, the company holds more cash than debt, which is a positive sign for financial stability and potential for investment in growth opportunities.

For investors seeking a deeper dive into Treace Medical's financials and strategic positioning, InvestingPro offers additional tips and metrics. Currently, there are 9 more InvestingPro Tips available for TMCI at https://www.investing.com/pro/TMCI, which could provide further insights into the company's performance and stock valuation.

Full transcript - Treace Medical Concepts Inc (TMCI) Q2 2024:

Operator: Good day, and thank you for standing by. Welcome to the Treace Medical Concepts Second Quarter 2024 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Vivian Cervantes, Gilmartin, Investor Relations. Please go ahead.

Vivian Cervantes: Good afternoon, everyone, and welcome to our second quarter 2024 earnings conference call. Participating from the company today will be John Treace, Chief Executive Officer; and Mark Hair, Chief Financial Officer. During the call, John will offer commentary on our commercial activities, followed by Mark for a detailed review of our second quarter financial results released after market closed today. We will host a question-and-answer session following our prepared remarks. Our press release can be found in the Investor Relations section of our website at investors.treace.com. This call is being recorded and will be archived in the Investors section of our website. Before we begin, we would like to remind you that it is in our intent that all forward-looking statements made during today's call will be protected under the Private Securities Litigation Reform Act of 1995. Any statements that relate to expectations or predictions of future events and market trends as well as our estimated results or performance are forward-looking statements. All forward-looking statements 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. All forward-looking statements are based upon current available information, and Treace Medical assumes no obligation to update these statements. Accordingly, you should not place undue reliance on these statements. Please refer to our SEC filings, including our Form 10-Q for the second quarter filed today and our Form 10-K for the full year 2023 filed on February 27, 2024, for a detailed presentation of risks. With that, I now turn the call over to John.

John Treace: Thank you, Vivian. Good afternoon, everyone, and thank you for joining us on our second quarter 2024 earnings conference call. We're pleased to report that the second quarter came in as expected. During the quarter, we made significant progress towards commercializing several new products aimed at broadening our presence in the bunion market, leveraging our Lapiplasty market leadership position and user base of over 3,000 surgeon customers as we prepare to enter the relatively nascent, minimally invasive osteotomy market, one which continues to grow in interest with doctors and patients alike. We have an active R&D engine focused on developing and delivering new technologies to accelerate and complement penetration of our $5 billion-plus U.S. total addressable bunion market. Inclusive of our new MIS osteotomy platforms, we have a full pipeline of more than 10 new products that we expect to commercialize starting in the back half of 2024 and throughout 2025. Turning to the quarter. Second quarter revenue was $44.5 million, representing 6% growth over the second quarter of 2023. Growth resulted from continued increases in our active surgeon base, an increase in surgical cases performed as well as favorable product revenue mix driven by broadening adoption of our SpeedPlate, Adductoplasty and other complementary products, which resulted in higher revenue per case. Building on these trends, we see clear opportunities to expand our share of procedure volumes from our growing surgeon customer base as we introduce new MIS osteotomy offerings, which are expected to become available in a limited fashion during the fourth quarter. We believe these new products, along with our flagship Lapiplasty and Adductoplasty system delivered by our direct bunion focused sales force, will provide a powerful and broad suite of technologies to comprehensively address the evolving needs of bunion surgeons and patients alike. Today, we believe the overall procedure volume in the U.S. bunion market is comprised of approximately 30% Lapidus Fusion and 70% osteotomies. And we estimate around 10% to 15% of the osteotomies are performed using MIS techniques. Notwithstanding the increasing interest in MIS osteotomies from surgeons and patients alike, MIS bunion surgery remains a technically challenging and predominantly freehand operation, thus limiting adoption by the broad foot and ankle surgeon community. For example, some surgeons have stated the learning curve for MIS osteotomies can be as high as 40 or more cases to achieve proficiency. It's with this current market backdrop that we plan to introduce two new MIS osteotomy approaches that build upon our core capabilities for highly reproducible, instrumented 3D bunion correction systems. And in doing so, we believe we can expand the minimally invasive segment of the osteotomy market by simplifying these MIS procedures and allowing surgeons to achieve reproducible 3D corrections. This strategy follows the Lapiplasty playbook, where we made a challenging freehand 3D Lapidus procedure reproducible and accessible to the broad foot and ankle surgeon community. And in doing so, helped expand the overall Lapidus segment of the market from approximately 15% in 2015 to 30% or more today. By our estimates, Lapiplasty has allowed us to capture, on average, nearly 50% of our most tenured surgeon cohorts annual bunion cases, which is something we take great pride in. This said, for our total surgeon base of more than 3,000 customers, Lapiplasty is closer to 25% of their average annual bunion case mix. Given this, we believe we can accelerate our penetration into the remaining 75% of their bunion procedures with not only Lapiplasty, but also with our two forthcoming MIS osteotomy solutions. We also believe we have a meaningful opportunity to attract new surgeon customers who today rely on metatarsal osteotomies for the vast majority of their bunion patients and, as such, have not yet been exposed to Lapiplasty. Let me share with you some additional color on our two forthcoming MIS osteotomy solutions. Our first system known as the Nanoplasty System was developed in conjunction with a team of highly experienced and internationally recognized MIS foot and ankle surgeons. Nanoplasty is designed to offer patients with a reproducible 3D bunion correction to resolve their lifestyle-limiting bunion pain. It features a highly refined instrumentation and specialized implant delivered through a small 1.5-centimeter discrete incision on the side of the foot, making it cosmetically appealing for patients. And importantly, consistent with other minimally invasive procedures, we believe this can translate to less swelling, less pain and allow patients the opportunity for rapid return to weight-bearing in a post-op boot or surgical shoe. We have already trained a significant cohort of surgeons on our Nanoplasty System. And based on their strong positive feedback, we believe Nanoplasty can disrupt this emerging market segment by dramatically reducing surgeon learning curves, simplifying the surgical procedure and ultimately allowing more surgeons to bring the benefits of our MIS approach to a greater number of their bunion patients. Our second MIS osteotomy offering is geared towards existing more established base of MIS foot surgeons who use screws for fixation in their metatarsal osteotomies. Our approach here is to offer this existing segment of the market, an instrumented and reproducible method to achieve their 3D bunion corrections. We are proud of these developments and believe that these two new MIS systems, coupled with our 3D Micro-Lapiplasty System provide a comprehensive suite of instrumented 3D MIS solutions to meet the evolving preferences of surgeons and their patients. In addition to these MIS offerings, we're also excited about other product introductions slated for the second half of 2024, which include our Mini-Adductoplasty System. This is our next-generation midfoot correction instrumentation, which reduces the Adductoplasty midfoot deformity correction procedure incision size by 50%. Red Point patient-specific instrumentation, which offers software-driven preoperative planning and patient-specific cut guides for bunion and related midfoot deformity corrections and a new SpeedPlate configuration designed for fusions of larger bones in the foot. We're pleased to announce that this new SpeedPlate configuration is now commercially available, and we're already receiving excellent feedback from surgeon users. Further, inclusive of the innovations we discussed here today, we have an active R&D team with a full pipeline of new products slated for a steady cadence of more than 10 introductions expected through 2025. We're excited to bring these new innovations to our growing base of 3,000-plus active surgeons through our established direct sales force as we continue to expand our footprint in the foot and ankle market. Turning to our financial outlook. We are reaffirming our full year 2024 revenue guidance of $201 million to $211 million, which reflects an increase of 7% to 13% over 2023 revenue. Before turning the call over to Mark for a review of our financial performance, let me provide an update on our clinical data and reimbursement. A key differentiating driver for our business is our commitment to clinical evidence, which we believe resonates with both surgeons and patients. From what we can see in the marketplace, we believe we continue to be the only industry participant with a growing body of clinical data, and we look forward to presenting 4-year data on our flagship ALIGN3D Lapiplasty study as well as our first interim report out of our Lapiplasty mini-incision clinical study at the upcoming 2024 American Orthopaedic Foot & Ankle Society Meeting in September. We believe patient data coming from our differentiated ALIGN3D studies resonate with surgeon and patient communities alike, further reinforcing market adoption of the Lapiplasty procedure. Finally, as many of you know, CMS recently released its proposed 2025 Medicare payment rates for hospital outpatient and ASC services to cover facility costs for surgical procedures, including supplies and implants used in the surgical case. As a reminder, our products are used in procedures covered by specific well-established CPT codes, and we're pleased to see that CMS is proposing to reassign CPT code 28297 a primary code used for Lapidus Fusion or the Lapiplasty procedure to APC 5115 with a proposed hospital outpatient rate of $12,756 for 2025. This represents an increase of $5,939 or 87% over 2024. In the ASC setting, the 2025 proposed payment is $9,719, an increase of 98% compared to $4,900 in 2024. For other bunion and related reimbursement codes relevant to Treace Medical, the proposed Medicare 2025 reimbursement rates are proposed to increase low single digits for the hospital outpatient and ASC settings. While we estimate the majority of our patient demographic to be commercially insured, Medicare rates often have influence on commercial payers. And while we are encouraged by this development, we remind you that these are proposed rules, which are not expected to be finalized until November and therefore, subject to change. Let me now turn the call over to Mark to review our financial performance. Mark?

Mark Hair: Thank you, John. Good afternoon, everyone. Revenue in the second quarter was $44.5 million, an increase of $2.5 million and 6% over the prior year. Growth was driven by increases in case volumes, favorable product revenue mix due to expanding adoption of our SpeedPlate technology and other complementary products as well as increases in our active surgeon base. Gross margin was 80.2% in the second quarter of 2024 compared to 81.7% in the second quarter of 2023. The decrease was primarily due to changes in product mix, increases and other cost of goods sold, partially offset by lower royalty rates. Second quarter 2024 gross margin of 80.2% was unchanged from the 80.2% gross margin reported in Q1. We Total operating expenses were $57.1 million in the second quarter of 2024. Total operating expenses were $47.3 million in the second quarter of 2023. The increase in operating expenses reflects strategic investments in our expanding direct sales channel, investments in product innovation and support for other commercial initiatives. Second quarter net loss attributable to common stockholders was $21.3 million or $0.34 per share compared to a net loss of $12.4 million or $0.20 per share for the same period of 2023. Cash, cash equivalents and marketable securities and investments receivable were $97 million as of June 30, 2024. Before concluding, let me turn to our outlook for the full year 2024. As John mentioned, we are reaffirming full year 2024 revenue guidance of $201 million to $211 million, which reflects an increase of 7% to 13% over 2023 revenue. For the full year 2024, we also continue to expect adjusted EBITDA improvement of approximately 50% compared to the full year 2023. With that, let me turn the call back to John.

John Treace: Thanks, Mark. In summary, we have a dynamic team here at Treace with a clear focus on building a comprehensive 3D bunion solutions company with a growing customer base exceeding 3,000 surgeon users and a large $5 billion-plus U.S. total addressable market. We also have a specialized and scalable business model focused on accelerating penetration into the bunion market by leveraging our large customer base and our direct-focused sales team with our forthcoming entry into the relatively nascent minimally invasive osteotomy segment, one that is experiencing growing interest from surgeons and patients alike. For these reasons, we believe we're uniquely positioned to expand our footprint in the foot and ankle market by continuing to deliver an exciting pipeline of differentiated reproducible solutions to comprehensively address the evolving needs of bunion surgeons and patients alike. With that, let me now turn the call over to the operator to open the line for your questions.

Operator: [Operator Instructions] And our first question comes from Robbie Marcus with JPMorgan (NYSE:JPM).

Lilia-Celine Lozada: This is actually Lily on for Robbie. You beat consensus by about $1 million to $2 million, but you're reiterating guidance. So is that just conservatism? Or are there other dynamics at play in the back half? Any color on your thoughts on the guide and what that implies for the second half of the year would be helpful.

Mark Hair: Lily, thanks for the question. This is Mark. As we look at what happened in Q2, Q2 came -- results really came in as expected. And so far, Q3 is tracking to forecast. We continue to receive updates from our sales organization and really believe that we've got a good handle on the field and how things are coming about. And so we just didn't think that there's -- not much has really changed since the last time that we changed our guidance and it hasn't been that long. So we just feel really good about the guidance that we gave last time.

Lilia-Celine Lozada: Got you. Okay. And just as a follow-up, I appreciate you're not breaking out kits and physician count regularly anymore, but can you qualitatively talk through how those pieces have been trending now with increased competition on the market? And how well have you been able to drive utilization and new doc adds in the right direction since you last gave us an update?

Mark Hair: Yes, this is Mark. Let me take a first stab at that, and maybe John will have some additional color. But with respect to our surgeon count, John mentioned on the prepared remarks that we're over 3,000 certain customers right now. So that implies about $150 million or so in the first half of the year. So on one hand, we said that we'd probably expect somewhere between $250 million to $300 million for the full year, so $150 million in already in the first half of the year, we tend to get more surgeon adds in the back half of the year. So we really feel like we're on track. We continue to see a lot of interest in our education events all over the country. We've got one coming up, a national event this weekend. We've got a packed house there. And so we continue to attract new surgeons. They come for our technology. They come to our training events and they end up using Lapiplasty. So we'll continue to do that. We feel like we're on course for this year to add new surgeon users. With respect to utilization, really not that much has changed since we talked last quarter. We identified somewhat of a change in utilization for a certain customer base. And we feel really good about what happened in Q2 that we were able to really forecast that right on what we thought was going to happen. And so Q2 came in as expected, and Q3 is tracking as well. So we believe that there hasn't really been an update to the trends that we identified last quarter.

Operator: And our next question comes from Danielle Antalffy with UBS.

Danielle Antalffy: Hey, guys, good afternoon. Thanks so much for taking the question. Excuse me, just a question, John. Just a question, John, you guys have a lot of new product launches coming, specifically the minimally invasive osteotomy. And I guess, as we look ahead, I appreciate you won't give 2025 guidance here on this call. But just directionally speaking, I mean, is it right to think of 2025 as a year of growth acceleration given these new product launches? Or is there something we might be missing from a headwind perspective that could make 2025 look a little bit more like 2024?

Mark Hair: Danielle, this is Mark. I'm going to take a first stab at that and then John, again, may have some additional color. But I love the question. You can probably hear some of the enthusiasm in John's voice as we're talking about this great opportunity having several new products into our large growing customer base. And so we are very excited about that. We're not really in a position right now to provide guidance for 2025, but we certainly believe that all these new products delivered by our direct sales channel to over 3,000 surgeons will definitely have a positive impact on our top line trajectory. As John mentioned, our customers are asking for more new products and our sales force is ready to deliver. So we look forward to providing more future updates on our progress. We can talk at the end of Q3 as we're getting into Q4 as far as how the new products will start to impact our business. And again, just to reiterate what John said, they're only going to be available in really light quantities in Q4. So not a lot of impact this year, but we definitely see it having a greater impact next year.

Danielle Antalffy: Understood. And then just a quick follow-up from a competitive perspective. I mean, to some extent, the increased competitive dynamics that you saw may have been due to trialing or docs just trying out different devices. I mean any change on the competitive front or still similar to what we saw in Q2 from the perspective of the pressures there?

John Treace: Yes, Danielle, it's John. Thanks for the question. It's pretty consistent with our last call back in May. It's not really one competitor, but multiple big, small, private, public offering knockoffs of Lapiplasty. Some of them offer osteotomy products as well that we don't today. But we've got a really strong attention on this with our sales team and the sales team is armed with enhanced customer analytics, and we're highly dialed into winning a greater share of bunion cases from our surgeon customers as we progress through this year. Like Mark said, the demand for our medical education events, which we're really focused now on our broadening line of MIS systems and that includes Micro-Lapiplasty, Mini-Adductoplasty, our versatile SpeedPlate platform. And in those events, surgeons are getting to test drive this new Nanoplasty System. This has been a really great format for us. It's generating a lot of excitement for our technologies with the surgeon attendees as they go home, and they're waiting there for Nanoplasty to come late in the year and into 2025. So a lot going on in the ground to maximize our share of customer cases over the next several months, while we're getting our sales team and customer base ready for their next product catalyst, namely the Red Point PSI and our MIS systems that will start in Q4.

Operator: And our next question comes from Drew Ranieri with Morgan Stanley (NYSE:MS).

Andrew Ranieri: Hi, John. Hi, Mark. Thanks for taking the questions. Maybe just to start. I mean we -- this kind of goes back to the competitive market types of questions you're just getting asked, but there was a competitor last week that kind of signaled that there's softness in the foot and ankle market, mainly foot. I was just wondering if you could give your perspective on maybe what you're seeing from a procedural standpoint, Mark, I know -- Mark and John, I know that you reiterated, reaffirmed your guidance, but just maybe talk to us about what you're seeing in the market and expectations for procedure growth from here?

John Treace: Yes, Drew, I'll take a first stab at that, and Mark can fill in behind me here. Dialing back time, we identified those softening trends late in Q1, and we saw them continue through April, and that resulted in our guidance change in early May. We spoke at that time predominantly about increasing headwinds from customers trialing some of these Lapiplasty knockoffs and some more kind of mounting interest in MIS osteotomies. I am aware of that large player that said they saw a soft first half as well. I don't know that they identified the same causes, but that's not to say that the causes they identified aren't at play as well. We just called it as clearly as we saw it to us at the time. But I'd say the -- like Mark said, Q3 is tracking as we would expect, and we think we did a pretty good and comprehensive job of generating that new guidance, and we're continuing to operate towards that. Mark, anything you want to add to that or...

Mark Hair: Yes, I'd agree. As our guidance that we talked about last quarter, we knew that there would be some toughness coming into second quarter, but that there's better comps in the back half of this year for us. And so the opportunity to have increased growth rates in both Q3 and Q4. So we still stand behind those prior statements and look forward to Q3 and Q4.

Andrew Ranieri: And maybe just to touch on the reaffirmed profitability guidance for the 50% improvement. Mark, can you just give a little bit more detail there in terms of what you're expecting for operating leverage for this year? And I'll ask anyway, but just should we think of next year as getting closer to breakeven or breakeven? Just any more details there would be great.

Mark Hair: Yes. Thanks, Drew. And I appreciate the question. Maybe I'll start with your last question first. First of all, we want to get through this year. We believe that we can make a really healthy improvement in the bottom line, the adjusted EBITDA. And so it's 50%. We believe that with continued growth into next year with our new products, we can absolutely do that. So we look forward to being EBITDA-positive next year. So with respect to some of the leverage, we've talked about some of the things in the past, that we've been a growing company. We've done a lot to invest into the business. We've grown a very large sales force, and we've really had to build the team. A lot of the building is done. We don't need to build as much as we have in the past with a maturer sales force, there's somewhat natural leverage that comes as they are longer with the company and they get more productive and achieve higher revenue ranges with their certain customers. So we believe that we've been able to reduce some of our costs. You'll see more of that in the coming quarters. We really gave our revised revenue guidance in the second quarter, and we've taken some actions throughout the organization, and we feel really good about these efforts, and you'll see improvement in the bottom line in both Q3 and Q4, especially in Q4 where we have our seasonal strong sales, and we're expecting positive EBITDA in that quarter as well.

Andrew Ranieri: Got it. And Mark, you did say positive EBITDA for 2025. I did hear that right, right?

Mark Hair: Yes. So we're -- we should turn that corner and be in positive territory next year.

Operator: And our next question comes from Ryan Zimmerman with BTIG.

Iseult McMahon: Hi. This is Izzy on for Ryan. So just to start out to touch on the proposed reimbursement rates for 2025. It's really great to see the lift in both the HOPD and the ASC settings. So as we think about 2025 and granted, you're not going to provide guidance here, but do you think the lift in reimbursement if the proposed rates are finalized will help you bring in new surgeons and drive adoption of your products?

John Treace: Eli, it's John. Yes, we're really encouraged and optimistic about these proposed changes and anticipate them being finalized in November. They go into effect Jan 1 of next year. So the way we look at it, we see several benefits. Right now, we think that somewhere between 40% and 50% of our cases are reimbursed under APC 5115 already in the hospital outpatient setting due to additional certain procedures performed along with the Lapidus code. That -- if that proposed rule becomes final, it could potentially change reimbursement for the remaining 50% to 60% of our cases that are currently reimbursed under the lower 5114. So that could be beneficial for sure, if it were to happen. And in the ASC setting, we can only see this as a real potential positive for us in terms of helping with access and could also benefit our more premium technologies being used more frequently in the more cost-conscious ASC settings where we're currently doing cases. So we can't really see any downside to this, only upsides. And again, a reminder that they're proposed or not yet final.

Mark Hair: Yes. And this is Mark. And we've heard some indications from some certain customers with respect to pricing, whether or not they have access to ASCs. And so this would absolutely alleviate some of the concerns that they might have to have access to our full line of products as well. So we feel encouraged by it. And we recognize that it's only proposed, it's not yet final. And so we'll be able to talk hopefully about this in future quarters.

Iseult McMahon: Got it. That's helpful. And then I heard your comments on the surgeon training that it's tracking pretty well through the first half of the year so far. But as we think about the new product introductions that you have and the feedback that you've received for them so far, do you think that 250, 300 new doctors in a year is sustainable going forward? Or is there any opportunity to increase that?

Mark Hair: Yes. That's a great question. Again, we haven't given any guidance specifically to next year. But I can tell you this, if our early trainings on some of our new systems is any indication, then that level of surgeon adds definitely seems reasonable next year. We've had a lot of surgeons, like John said, our training is focused on MIS procedures, including our minimally invasive Micro-Lapiplasty and our Mini-Adductoplasty, and then we're combining that with some of the MIS osteotomy solutions as well. And I think that theme is really resonating across a lot of surgeons. Not only are we inviting our current surgeon customers, but it's giving us a new opportunity to reach outside of our customer base and really get them excited about MIS osteotomy platforms, a space where we've never played before. And as John mentioned, some surgeons just have a bias to one type of procedure versus another. And so there are a lot of surgeons out there that have a bias to osteotomies. And so we really haven't had a lot of interaction with them, and this opens up a new door for us. And so we're not really giving you the number right now, but if the early interest that we've seen is any indication, we're definitely feeling good about next year's trends as well.

Operator: And our next question comes from Richard Newitter with Truist Securities.

Benjamin Goldstein: This is Ben on for Rich. Can you hear me?

Mark Hair: We can.

Benjamin Goldstein: Yes. All right. So earlier in the call, you mentioned a pipeline of 10 new products to launch through 2025. I was wondering which of these you think might be the most needle-moving? And anything else on these launches you'd like to share?

John Treace: Yes. Ben, it's John. Obviously, the MIS osteotomy platforms are going to be, I think, a real exciting new category for us to enter. It's going to do a lot of things. We look at it as a one plus one is 3 having this unique opportunity to provide incremental osteotomy solutions to our 3,000-plus Lapiplasty surgeon base. And then like Mark said, also attract new Lapiplasty users through our osteotomy offerings that haven't used Treace Medical products because they predominantly do osteotomies. And then it's our opportunity to take SpeedPlate in all our other complementary products and wrap them around those new surgeon users as well. Kind of regarding the -- beyond the products we covered on the call, we're not really giving details about those at this time, but I can tell you they'll fall into 1 of 3 categories. And one would be those that help accelerate our penetration into the core bunion and midfoot correction markets that we serve today. And the second group would be those that target new incremental procedures that tie back to our core procedure base like we've done before with the Adductoplasty and our Hammertoe offerings. And the third would be other technology platforms or product lines that allow our reps to more fully service the comprehensive product needs in their cases and become more of a one-stop shop in these more complex procedures and as well as the straightforward procedure. So I look forward to sharing more in future calls and give you guys more detail on those as they come closer to fruition. But for now, that's pretty much what we can say.

Operator: And our next question comes from Harrison Parsons (NYSE:PSN) with Stephens.

Harrison Parsons: Hey, General Mark, this is Harrison on for George. I wanted I wanted to circle back on the proposed CMS increases. I was wondering if you all expect to take price just on the base Lapiplasty procedure? Or should we think of it more as a blended ASP increase from more premium products? And then also, I was wondering if you could break out specifically your exposure in the commercial market versus CMS?

Mark Hair: Yes. So this is Mark, Harrison. Thanks for the question. Let me start with the first part there. I don't think this is really an opportunity where we're looking to take price. We have a really nice portfolio of fixation offerings for surgeons. We have some earlier generation products that are fantastic. They've been using our clinical studies. We know that they work, and we also have some newer generation SpeedPlate. And so we have a nice offering. A lot of these come at different price points for our surgeon customers. And so I think what it will really do is just allow greater access in whatever environment they're in, whether it's a hospital or ASC setting. And we also offer a lot of complementary products as well. And it's very common that other procedures are performed at the same time that the bunion is corrected. And so it gives us an opportunity to maybe benefit from our other complementary products as well. But we're not viewing it right now as an opportunity to raise prices, but I think it just makes it easier and more accessible to our customer surgeons. The other part of the question was more -- is their exposure to commercial pay. We know that they tend to fall in line or follow some of the -- what CMS has. So -- but currently, we believe and in most cases, the commercial payers are reimbursing at a little bit higher rate anyway right now. So I just don't know that it creates exposure one way or the other, but definitely from a CMS Medicare perspective makes it a little bit more accessible for our products in whatever setting hospitals or ASCs.

John Treace: And Harrison, I think you were asking about mix maybe of commercial pay. The majority of our patients are commercial pay.

Harrison Parsons: Got it. Yes, that sounds good. And then I did want to ask about the limited market release of your MIS osteotomy in the fourth quarter. I was wondering if you could quantify the financial impact you expect in terms of your guidance for the full year?

Mark Hair: No, that's a great question, and thanks for asking it because I want to make sure that it's really clear for people. When we launch products, we tend to do it in a very limited fashion. So we'll put it into some surgeon hands in the fourth quarter, but we really don't see it having a material impact on the quarter at all. Maybe these products may be available late in the quarter. It will be nice to have them out there. It will be nice to have additional trainings and surgeons have the first bite at the apple and have options as far as how to treat their patients. We'll have a more full suite of options for them, but it's really not going to move the needle in Q4. I wouldn't say that it's already -- any upside is already baked into the numbers. So I don't think there should be any increase or change to what expectations are out there for the fourth quarter.

Operator: And this concludes the question-and-answer session. I would now like to turn it back to Vivian Cervantes for closing remarks.

Vivian Cervantes: Thank you, operator. On behalf of Treace Medical, thanks, everyone, for joining us today. This concludes our call, and we look forward to our next update following the close of the third quarter of 2024.

Operator: This does conclude the program. You may now disconnect.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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