NASDAQ:TMCI Treace Medical Concepts Q2 2024 Earnings Report $7.26 -0.08 (-1.09%) Closing price 04:00 PM EasternExtended Trading$7.26 0.00 (0.00%) As of 04:05 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Treace Medical Concepts EPS ResultsActual EPS-$0.34Consensus EPS -$0.29Beat/MissMissed by -$0.05One Year Ago EPS-$0.20Treace Medical Concepts Revenue ResultsActual Revenue$44.46 millionExpected Revenue$43.00 millionBeat/MissBeat by +$1.46 millionYoY Revenue Growth+6.00%Treace Medical Concepts Announcement DetailsQuarterQ2 2024Date8/6/2024TimeAfter Market ClosesConference Call DateTuesday, August 6, 2024Conference Call Time4:30PM ETUpcoming EarningsTreace Medical Concepts' Q1 2025 earnings is scheduled for Thursday, May 8, 2025, with a conference call scheduled at 4:30 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2025 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfilePowered by Treace Medical Concepts Q2 2024 Earnings Call TranscriptProvided by QuartrAugust 6, 2024 ShareLink copied to clipboard.There are 10 speakers on the call. Operator00:00:00Good day, and thank you for standing by. Welcome to the Tris Medical Concepts 2nd Quarter 2024 Earnings Conference Call. At this time, all participants are in listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. Operator00:00:32I would now like to hand the conference over to your first speaker today, Vivian Cervantes, Gilmartin Investor Relations. Please go ahead. Speaker 100:00:42Good afternoon, everyone, and welcome to our Q2 2024 earnings conference call. Participating from the company today will be John Treeff, 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 Q2 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. Speaker 100:01:17Trees.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 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. Speaker 100:01:52These 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 Treas 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 Q2 filed today and our Form 10 ks for full year 2023 filed on February 27, 2024 for detailed presentation of risks. With that, I now turn the call over to John. Speaker 200:02:33Thank you, Vivian. Good afternoon, everyone, and thank you for joining us on our Q2 2024 earnings conference presence in the bunion market, leveraging our lapoplasty 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 and D engine focused on developing and delivering new technologies to accelerate and complement penetration of our $5,000,000,000 plus U. S. Total addressable bunion market. Speaker 200:03:18Inclusive 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 twenty twenty four and throughout 2025. Turning to the quarter. 2nd quarter revenue was $44,500,000 representing 6% growth over the Q2 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 Speed Plate, 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 Q4. Speaker 200:04:13We believe these new products along with our flagship lapoplasty and adductoplasty 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. Speaker 200:04:46Notwithstanding 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 2 new MIS osteotomy approaches that build upon our core capabilities for highly reproducible instrumented 3 d 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 3 d corrections. This strategy follows the lapoplasty playbook where we made a challenging freehand 3 d 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. Speaker 200:05:54By 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, laparoplasty 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 lapoplasty, but also with our 2 forthcoming MIS osteotomy solutions. We also believe we have a meaningful opportunity to attract new surgeon lapoplasty. Let me share with you some additional color on our 2 forthcoming MIS osteotomy solutions. Speaker 200:06:44Our 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 3 d 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. Speaker 200:07:49Our 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 3 d bunion corrections. We're proud of these developments and believe that these 2 new MIS systems coupled with our 3 d microlappoplasty system provide a comprehensive suite of instrumented 3 d 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%. Speaker 200:08:45Redpoint patient specific instrumentation, which offers software driven preoperative planning and patient specific cut guides for bunion and related midfoot deformity corrections and a new Speedplay configuration designed for fusions of larger bones in the foot. We're pleased to announce that this new Speedplay 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 and 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 $201,000,000 to 211,000,000 dollars which reflects an increase of 7% to 13% over 2023 revenue. Speaker 200:09:47Before turning the call over to Mark for a review of our financial performance, let me provide an update on our clinical data and reimbursement. The 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 lapoplasty study as well as our first interim report out of our lapoplasty mini incision clinical study at the upcoming 2024 American Orthopedic Foot and Ankle Society meeting in September. We believe patient data coming from our differentiated and ALIGN3D studies resonate with surgeon and patient communities alike, further reinforcing market adoption of the lapoplasty procedure. Speaker 200:10:38Finally, 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 28,297, a primary code used for lapidus fusion or the lapoplasty procedure to APC-five thousand one hundred and fifteen with a proposed hospital outpatient rate of $12,756 for 2025. This represents an increase of $5,939 or 87 percent 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 of related reimbursement codes relevant to Treese Medical, the proposed Medicare 2025 reimbursement rates are proposed to increase low single digits for the hospital outpatient and ASC settings. Speaker 200:11:49While 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? Speaker 300:12:12Thank you, John. Good afternoon, everyone. Revenue in the 2nd quarter was $44,500,000 an increase of $2,500,000 and 6% over the prior year. Growth was driven by increases in case volumes, favorable product revenue mix due to expanding adoption of our Speedplay technology and other complementary products as well as increases in our active surgeon base. Gross margin was 80.2% in the Q2 of 2024 compared to 81.7% in the Q2 of 2023. Speaker 300:12:46The decrease was primarily due to changes in product mix, increases in other cost of goods sold, partially offset by lower royalty rates. 2nd quarter 2024 gross margin of 80.2% was unchanged from the 80.2% gross margin reported in Q1. Total operating expenses were $57,100,000 in the Q2 of 2024. Total operating expenses were $47,300,000 in the Q2 of 2023. The increase in operating expenses reflect strategic investments and our expanding direct sales channel, investments in product innovation and support for other commercial initiatives. Speaker 300:13:282nd quarter net loss attributable to common stockholders was $21,300,000 or $0.34 per share compared to a net loss of $12,400,000 or $0.20 per share for the same period of 2023. Cash, cash equivalents and marketable securities and investments receivable were $97,000,000 as of June 30, 2024. Before concluding, let me turn to our outlook for the full year of 2024. As John mentioned, we are reaffirming full year 2024 revenue guidance of $201,000,000 to $211,000,000 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. Speaker 300:14:21With that, let me turn the call back to John. Speaker 200:14:24Thanks, Mark. In summary, we have a dynamic team here at Treest with a clear focus on building a comprehensive 3 d bunion solutions company with a growing customer base exceeding 3,000 surgeon users and a large $5,000,000,000 plus U. S. Total addressable market. We also have a specialized and scalable business model focused on accelerating penetration into the Bunyan 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. Speaker 200:15:00For 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. Operator00:15:21Thank you. At this time, we will conduct a question and answer session. And our first question comes from Robbie Marcus with JPMorgan. Speaker 400:15:48Hi, this is actually Lily on for Robbie. Thanks for taking the question. You beat consensus by about $1,000,000 to $2,000,000 but your reiterating guidance, so is that just conservatism or are there other dynamics that 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. Speaker 300:16:11Yes, Lily. Hi. Thanks for the question. This is Mark. As we look at what happened in Q2, Q2 came results really came in as expected. Speaker 300:16:23So 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 still think that there is 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. Speaker 400:16:53Got you. Okay. And just as a follow-up, I appreciate you're not breaking out kids 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? Thanks so Speaker 300:17:18much. 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 surgeon customers right now. Speaker 300:17:31So that implies about 150 or so in the first half of the year. So on one hand, we said that we'd probably expect somewhere between 250 to 300 for the full year or so, about 150 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. Speaker 300:17:55We'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 lapoplasties. Speaker 300:18:11So 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 our 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. Speaker 300:18:42So we believe there hasn't really been an update to the trends that we identified last quarter. Speaker 400:18:50Great. Thank you. Operator00:18:58And our next question comes from Danielle Antalffy with UBS. Speaker 500:19:04Hey guys, good afternoon. Thanks so much for taking the question. Excuse me, 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? Speaker 500:19:30Or is there something we might be missing from a headwind perspective that could make 2025 look a little bit more like 2024? Speaker 300:19:40Hey, Danielle, this is Mark. I'm going to take a first stab at that and then John again may have some additional color. But love the question. You could 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. Speaker 300:19:59We'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 new more new products and our sales force is ready to deliver. 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. Speaker 300:20:39So not a lot of impact this year, but we definitely see it having a greater impact next year. Speaker 500:20:45Understood. 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 Zach's just trying out different devices. I mean any change on the competitive front are still similar to what we saw in Q2 from a perspective of the pressures there? Thanks so much. Speaker 200:21:11Yes, 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 lapoplasty. Some of them offer osteotomy products as well that we don't today. Speaker 200:21:32But 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 Bunyan 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 lapoplasty, mini adductoplasty, our versatile Speedplay 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 these surgeon attendees as they go home and they're waiting there for a 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 the next product catalyst namely the Redpoint PSI and our MIS systems that will start in Q4. Speaker 400:22:40Thanks so much. Speaker 200:22:42Sure. Speaker 300:22:49And Operator00:22:51our next question comes from Drew Ranieri with Morgan Stanley. Speaker 600:22:57Hi, 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 were 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. Speaker 600:23:16I was just wondering if you could give your perspective on maybe what you're seeing from a procedural standpoint. 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? Thanks. Speaker 200:23:35Yes, 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 flopoplasty 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. Speaker 200:24:20We 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? Speaker 300:24:42Yes, I'd agree. As our guidance that we talked about last quarter, we knew that there would be some toughness coming into 2nd 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. Speaker 600:25:08Thanks. And maybe just to touch on the reaffirm 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. Speaker 600:25:33Thanks for taking the questions. Speaker 300:25:35Yes. Thanks Drew and 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. Speaker 300:25:49And 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. Speaker 300:26:11We've grown a very large sales force. We've really had to build the team. A lot of building is done. We don't need to build as much as we have in the past. With the mature 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 surgeon customers. Speaker 300:26:34So, 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 Q2 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. And especially in Q4 where we have our seasonal strong sales and we're expecting positive EBITDA in that quarter as well. Speaker 600:27:10Got it. And Mark, you did say positive EBITDA for 2025. I did hear that right. Speaker 300:27:16Yes. So we're we should turn that corner and be in positive territory next year. Speaker 600:27:23Great. Thanks for taking the questions guys. Thank you. Operator00:27:32And our next question comes from Ryan Zimmerman with BTIG. Speaker 700:27:38Hi, 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 setting. 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 product? Speaker 200:28:08Hi, Ely, it's John. Yes, we're really encouraged and optimistic about these proposed changes and anticipate them being finalized in November. They'd 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% 50 percent of our cases are reimbursed under APC 5,115 already in the hospital outpatient setting due to additional certain procedures performed along with the Lapidus code. Speaker 200:28:45If 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 reminder that they're proposed are not yet final. Speaker 300:29:27And 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. Speaker 700:29:57Got it. Thank you. That's helpful. And then I heard your comments on the surgeon training that 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 used or you've received for them so far, do you think that 250, 300 new doctors in a year is sustainable going forward? Speaker 700:30:17Or is there any opportunity to increase that? Thanks for taking the questions. Speaker 300:30:22Yes. 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. Speaker 300:30:42Like John said, our training is focused on MIS procedures including our minimally invasive microglapoplasty 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. Speaker 300:31:30And 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 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. Operator00:31:53One moment for our next question. And our next question comes from Richard Newitter with Chua Securities. Speaker 800:32:05Hi, this is Ben on for Rich. Can you hear me? Speaker 300:32:09We can. Operator00:32:10Yes. All Speaker 800:32:11right. 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? Speaker 200:32:24Yes. Hi, 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 1 plus 1 is 3 having this unique opportunity to provide incremental osteotomy solutions to our 3,000 plus lapoplasty surgeon base. Speaker 200:32:49And then like Mark said also attract new lapoplasty users through our osteotomy offerings that haven't used Tree's medical products because they predominantly do osteotomies. And then it's our opportunity to take Speedplate and 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 a ductoplasty and our hammer toe offerings. Speaker 200:33:37And 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 procedures. So, 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. Speaker 800:34:03Okay. Thank you. Speaker 200:34:06Welcome. Operator00:34:12And our next question comes from Harrison Parsons with Stephens. Speaker 900:34:19Hey, John and Mark, this is Harrison on for George. Good afternoon and thanks for taking the questions. Good morning. I wanted to hey, guys. I wanted to circle back on the proposed CMS increases. Speaker 900:34:33I was wondering if you all expect to take price just on the base lapoplasty 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? Speaker 300:35:01Yes. 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. Speaker 300:35:11We have really nice portfolio of fixation offerings for our surgeons. We have some earlier generation products that are fantastic. They've been used in our clinical studies. We know that they work and we also have some newer generation SpeedPlate. So we have a nice offering. Speaker 300:35:26A 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 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 blending is corrected. And so it gives us an opportunity to maybe benefit from our other complementary products as well. Speaker 300:35:58But 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 what CMS has. So we 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 and whatever setting hospital through ASCs. Speaker 200:36:44And Harrison, I think you were asking about mix maybe of commercial pay. The majority of our patients are commercial pay. Speaker 900:36:56Got it. Yes, that sounds good. And then I did want to ask about the limited market release of your MIS osteotomy in the Q4. I was wondering if you could quantify the financial impact you expect in terms of your guidance for the full year? Speaker 300:37:15No, 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's hands in the Q4, but we really don't see it having a material impact on the quarter at all. It may be these products may be available late in the quarter. It will be nice to have them out there. Speaker 300:37:39It 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 Q4. Speaker 900:38:09Sounds good. Thanks for taking the questions. Speaker 200:38:13Sure. Thank you. Operator00:38:16And this concludes the question and answer session. I would now like to turn it back to Vivien Cervantes for closing remarks. Speaker 100:38:24Thank you, operator. On behalf of Treeds Medical, thanks everyone for joining us today. This concludes our call and we look forward to our next update following the close of the Q3 2024.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallTreace Medical Concepts Q2 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Quarterly report(10-Q) Treace Medical Concepts Earnings HeadlinesTMCI Investors Have Opportunity to Lead Treace Medical Concepts, Inc. Securities Fraud LawsuitMay 2 at 6:57 PM | prnewswire.comTMCI INVESTOR ALERT: Bronstein, Gewirtz & Grossman LLC Announces that Treace Medical Concepts, Inc. Investors with Substantial Losses Have Opportunity to Lead Class Action LawsuitMay 2 at 4:00 PM | prnewswire.comThink NVDA’s run was epic? You ain’t seen nothin’ yetAsk most investors and they’ll probably tell you Nvidia is the undisputed AI stock of the decade. In 2023, it surged 239%. And in 2024, it soared another 171% on the year… But what if I told you there was a way to target those types of “peak Nvidia” profit opportunities in 24 hours or less?May 2, 2025 | Timothy Sykes (Ad)ROSEN, A RANKED AND LEADING LAW FIRM, Encourages Treace Medical Concepts, Inc. Investors to Secure Counsel Before Important Deadline in Securities Class Action – TMCIMay 2 at 3:58 PM | globenewswire.comTMCI LAWSUIT ALERT: Levi & Korsinsky Notifies Treace Medical Concepts, Inc. Investors of a Class Action Lawsuit and Upcoming DeadlineMay 2 at 2:06 PM | globenewswire.comTreace Medical Concepts, Inc. (TMCI) Investors Who Lost Money Have Opportunity to Lead Securities Fraud LawsuitMay 2 at 12:00 PM | prnewswire.comSee More Treace Medical Concepts Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Treace Medical Concepts? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Treace Medical Concepts and other key companies, straight to your email. Email Address About Treace Medical ConceptsTreace Medical Concepts (NASDAQ:TMCI), a medical technology company, designs, manufactures, and markets medical devices in the United States. The company offers Lapiplasty 3D bunion correction system that combines instruments, implants, and surgical methods designed to surgically correct three planes of the bunion deformity. It also provides Lapiplasty mini-incision system designed to allow the Lapiplasty procedure to be performed through a 3.5cm incision. In addition, the company offers Adductoplasty system designed for reproducible realignment, stabilization, and fusion of the midfoot. 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There are 10 speakers on the call. Operator00:00:00Good day, and thank you for standing by. Welcome to the Tris Medical Concepts 2nd Quarter 2024 Earnings Conference Call. At this time, all participants are in listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. Operator00:00:32I would now like to hand the conference over to your first speaker today, Vivian Cervantes, Gilmartin Investor Relations. Please go ahead. Speaker 100:00:42Good afternoon, everyone, and welcome to our Q2 2024 earnings conference call. Participating from the company today will be John Treeff, 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 Q2 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. Speaker 100:01:17Trees.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 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. Speaker 100:01:52These 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 Treas 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 Q2 filed today and our Form 10 ks for full year 2023 filed on February 27, 2024 for detailed presentation of risks. With that, I now turn the call over to John. Speaker 200:02:33Thank you, Vivian. Good afternoon, everyone, and thank you for joining us on our Q2 2024 earnings conference presence in the bunion market, leveraging our lapoplasty 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 and D engine focused on developing and delivering new technologies to accelerate and complement penetration of our $5,000,000,000 plus U. S. Total addressable bunion market. Speaker 200:03:18Inclusive 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 twenty twenty four and throughout 2025. Turning to the quarter. 2nd quarter revenue was $44,500,000 representing 6% growth over the Q2 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 Speed Plate, 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 Q4. Speaker 200:04:13We believe these new products along with our flagship lapoplasty and adductoplasty 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. Speaker 200:04:46Notwithstanding 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 2 new MIS osteotomy approaches that build upon our core capabilities for highly reproducible instrumented 3 d 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 3 d corrections. This strategy follows the lapoplasty playbook where we made a challenging freehand 3 d 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. Speaker 200:05:54By 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, laparoplasty 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 lapoplasty, but also with our 2 forthcoming MIS osteotomy solutions. We also believe we have a meaningful opportunity to attract new surgeon lapoplasty. Let me share with you some additional color on our 2 forthcoming MIS osteotomy solutions. Speaker 200:06:44Our 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 3 d 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. Speaker 200:07:49Our 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 3 d bunion corrections. We're proud of these developments and believe that these 2 new MIS systems coupled with our 3 d microlappoplasty system provide a comprehensive suite of instrumented 3 d 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%. Speaker 200:08:45Redpoint patient specific instrumentation, which offers software driven preoperative planning and patient specific cut guides for bunion and related midfoot deformity corrections and a new Speedplay configuration designed for fusions of larger bones in the foot. We're pleased to announce that this new Speedplay 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 and 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 $201,000,000 to 211,000,000 dollars which reflects an increase of 7% to 13% over 2023 revenue. Speaker 200:09:47Before turning the call over to Mark for a review of our financial performance, let me provide an update on our clinical data and reimbursement. The 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 lapoplasty study as well as our first interim report out of our lapoplasty mini incision clinical study at the upcoming 2024 American Orthopedic Foot and Ankle Society meeting in September. We believe patient data coming from our differentiated and ALIGN3D studies resonate with surgeon and patient communities alike, further reinforcing market adoption of the lapoplasty procedure. Speaker 200:10:38Finally, 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 28,297, a primary code used for lapidus fusion or the lapoplasty procedure to APC-five thousand one hundred and fifteen with a proposed hospital outpatient rate of $12,756 for 2025. This represents an increase of $5,939 or 87 percent 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 of related reimbursement codes relevant to Treese Medical, the proposed Medicare 2025 reimbursement rates are proposed to increase low single digits for the hospital outpatient and ASC settings. Speaker 200:11:49While 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? Speaker 300:12:12Thank you, John. Good afternoon, everyone. Revenue in the 2nd quarter was $44,500,000 an increase of $2,500,000 and 6% over the prior year. Growth was driven by increases in case volumes, favorable product revenue mix due to expanding adoption of our Speedplay technology and other complementary products as well as increases in our active surgeon base. Gross margin was 80.2% in the Q2 of 2024 compared to 81.7% in the Q2 of 2023. Speaker 300:12:46The decrease was primarily due to changes in product mix, increases in other cost of goods sold, partially offset by lower royalty rates. 2nd quarter 2024 gross margin of 80.2% was unchanged from the 80.2% gross margin reported in Q1. Total operating expenses were $57,100,000 in the Q2 of 2024. Total operating expenses were $47,300,000 in the Q2 of 2023. The increase in operating expenses reflect strategic investments and our expanding direct sales channel, investments in product innovation and support for other commercial initiatives. Speaker 300:13:282nd quarter net loss attributable to common stockholders was $21,300,000 or $0.34 per share compared to a net loss of $12,400,000 or $0.20 per share for the same period of 2023. Cash, cash equivalents and marketable securities and investments receivable were $97,000,000 as of June 30, 2024. Before concluding, let me turn to our outlook for the full year of 2024. As John mentioned, we are reaffirming full year 2024 revenue guidance of $201,000,000 to $211,000,000 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. Speaker 300:14:21With that, let me turn the call back to John. Speaker 200:14:24Thanks, Mark. In summary, we have a dynamic team here at Treest with a clear focus on building a comprehensive 3 d bunion solutions company with a growing customer base exceeding 3,000 surgeon users and a large $5,000,000,000 plus U. S. Total addressable market. We also have a specialized and scalable business model focused on accelerating penetration into the Bunyan 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. Speaker 200:15:00For 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. Operator00:15:21Thank you. At this time, we will conduct a question and answer session. And our first question comes from Robbie Marcus with JPMorgan. Speaker 400:15:48Hi, this is actually Lily on for Robbie. Thanks for taking the question. You beat consensus by about $1,000,000 to $2,000,000 but your reiterating guidance, so is that just conservatism or are there other dynamics that 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. Speaker 300:16:11Yes, Lily. Hi. Thanks for the question. This is Mark. As we look at what happened in Q2, Q2 came results really came in as expected. Speaker 300:16:23So 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 still think that there is 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. Speaker 400:16:53Got you. Okay. And just as a follow-up, I appreciate you're not breaking out kids 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? Thanks so Speaker 300:17:18much. 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 surgeon customers right now. Speaker 300:17:31So that implies about 150 or so in the first half of the year. So on one hand, we said that we'd probably expect somewhere between 250 to 300 for the full year or so, about 150 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. Speaker 300:17:55We'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 lapoplasties. Speaker 300:18:11So 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 our 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. Speaker 300:18:42So we believe there hasn't really been an update to the trends that we identified last quarter. Speaker 400:18:50Great. Thank you. Operator00:18:58And our next question comes from Danielle Antalffy with UBS. Speaker 500:19:04Hey guys, good afternoon. Thanks so much for taking the question. Excuse me, 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? Speaker 500:19:30Or is there something we might be missing from a headwind perspective that could make 2025 look a little bit more like 2024? Speaker 300:19:40Hey, Danielle, this is Mark. I'm going to take a first stab at that and then John again may have some additional color. But love the question. You could 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. Speaker 300:19:59We'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 new more new products and our sales force is ready to deliver. 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. Speaker 300:20:39So not a lot of impact this year, but we definitely see it having a greater impact next year. Speaker 500:20:45Understood. 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 Zach's just trying out different devices. I mean any change on the competitive front are still similar to what we saw in Q2 from a perspective of the pressures there? Thanks so much. Speaker 200:21:11Yes, 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 lapoplasty. Some of them offer osteotomy products as well that we don't today. Speaker 200:21:32But 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 Bunyan 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 lapoplasty, mini adductoplasty, our versatile Speedplay 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 these surgeon attendees as they go home and they're waiting there for a 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 the next product catalyst namely the Redpoint PSI and our MIS systems that will start in Q4. Speaker 400:22:40Thanks so much. Speaker 200:22:42Sure. Speaker 300:22:49And Operator00:22:51our next question comes from Drew Ranieri with Morgan Stanley. Speaker 600:22:57Hi, 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 were 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. Speaker 600:23:16I was just wondering if you could give your perspective on maybe what you're seeing from a procedural standpoint. 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? Thanks. Speaker 200:23:35Yes, 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 flopoplasty 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. Speaker 200:24:20We 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? Speaker 300:24:42Yes, I'd agree. As our guidance that we talked about last quarter, we knew that there would be some toughness coming into 2nd 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. Speaker 600:25:08Thanks. And maybe just to touch on the reaffirm 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. Speaker 600:25:33Thanks for taking the questions. Speaker 300:25:35Yes. Thanks Drew and 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. Speaker 300:25:49And 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. Speaker 300:26:11We've grown a very large sales force. We've really had to build the team. A lot of building is done. We don't need to build as much as we have in the past. With the mature 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 surgeon customers. Speaker 300:26:34So, 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 Q2 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. And especially in Q4 where we have our seasonal strong sales and we're expecting positive EBITDA in that quarter as well. Speaker 600:27:10Got it. And Mark, you did say positive EBITDA for 2025. I did hear that right. Speaker 300:27:16Yes. So we're we should turn that corner and be in positive territory next year. Speaker 600:27:23Great. Thanks for taking the questions guys. Thank you. Operator00:27:32And our next question comes from Ryan Zimmerman with BTIG. Speaker 700:27:38Hi, 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 setting. 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 product? Speaker 200:28:08Hi, Ely, it's John. Yes, we're really encouraged and optimistic about these proposed changes and anticipate them being finalized in November. They'd 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% 50 percent of our cases are reimbursed under APC 5,115 already in the hospital outpatient setting due to additional certain procedures performed along with the Lapidus code. Speaker 200:28:45If 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 reminder that they're proposed are not yet final. Speaker 300:29:27And 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. Speaker 700:29:57Got it. Thank you. That's helpful. And then I heard your comments on the surgeon training that 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 used or you've received for them so far, do you think that 250, 300 new doctors in a year is sustainable going forward? Speaker 700:30:17Or is there any opportunity to increase that? Thanks for taking the questions. Speaker 300:30:22Yes. 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. Speaker 300:30:42Like John said, our training is focused on MIS procedures including our minimally invasive microglapoplasty 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. Speaker 300:31:30And 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 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. Operator00:31:53One moment for our next question. And our next question comes from Richard Newitter with Chua Securities. Speaker 800:32:05Hi, this is Ben on for Rich. Can you hear me? Speaker 300:32:09We can. Operator00:32:10Yes. All Speaker 800:32:11right. 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? Speaker 200:32:24Yes. Hi, 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 1 plus 1 is 3 having this unique opportunity to provide incremental osteotomy solutions to our 3,000 plus lapoplasty surgeon base. Speaker 200:32:49And then like Mark said also attract new lapoplasty users through our osteotomy offerings that haven't used Tree's medical products because they predominantly do osteotomies. And then it's our opportunity to take Speedplate and 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 a ductoplasty and our hammer toe offerings. Speaker 200:33:37And 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 procedures. So, 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. Speaker 800:34:03Okay. Thank you. Speaker 200:34:06Welcome. Operator00:34:12And our next question comes from Harrison Parsons with Stephens. Speaker 900:34:19Hey, John and Mark, this is Harrison on for George. Good afternoon and thanks for taking the questions. Good morning. I wanted to hey, guys. I wanted to circle back on the proposed CMS increases. Speaker 900:34:33I was wondering if you all expect to take price just on the base lapoplasty 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? Speaker 300:35:01Yes. 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. Speaker 300:35:11We have really nice portfolio of fixation offerings for our surgeons. We have some earlier generation products that are fantastic. They've been used in our clinical studies. We know that they work and we also have some newer generation SpeedPlate. So we have a nice offering. Speaker 300:35:26A 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 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 blending is corrected. And so it gives us an opportunity to maybe benefit from our other complementary products as well. Speaker 300:35:58But 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 what CMS has. So we 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 and whatever setting hospital through ASCs. Speaker 200:36:44And Harrison, I think you were asking about mix maybe of commercial pay. The majority of our patients are commercial pay. Speaker 900:36:56Got it. Yes, that sounds good. And then I did want to ask about the limited market release of your MIS osteotomy in the Q4. I was wondering if you could quantify the financial impact you expect in terms of your guidance for the full year? Speaker 300:37:15No, 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's hands in the Q4, but we really don't see it having a material impact on the quarter at all. It may be these products may be available late in the quarter. It will be nice to have them out there. Speaker 300:37:39It 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 Q4. Speaker 900:38:09Sounds good. Thanks for taking the questions. Speaker 200:38:13Sure. Thank you. Operator00:38:16And this concludes the question and answer session. I would now like to turn it back to Vivien Cervantes for closing remarks. Speaker 100:38:24Thank you, operator. On behalf of Treeds Medical, thanks everyone for joining us today. This concludes our call and we look forward to our next update following the close of the Q3 2024.Read morePowered by