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Good day and thank you for standing by. Welcome to Treace Medical Concepts Third Quarter 2023 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to turn the conference over to your first speaker today, Julie Dewey. Please go ahead.

Good afternoon, everyone, and welcome to our third quarter 2023 earnings conference call. We appreciate you joining us. I'm Julie Dewey, Treace's Chief Communications and IR Officer. With me today are John Treace, Chief Executive Officer; and Mark Hair, Chief Financial Officer. During the call, John and Mark will offer commentary on our commercial activity and review our third quarter financial results released after the close of market today, after which we'll host a question-and-answer session. The press release and supplemental materials 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'd 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. 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 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 third quarter to be filed today and our Form 10-K for the full year 2022, filed on March 8, 2023, for a detailed presentation of risks. With that, I will now turn the call over to John.

Thank you, Julie. Good afternoon, everyone, and thank you for joining us. I'm going to focus my comments today on our third quarter results, the exciting progress of our SpeedPlate implant launch and other growth drivers. Following my comments, Mark will cover the specifics of our Q3 results and guidance. We continue to execute on our strategic plan, resulting in year-to-date U.S. revenue growth of 36% that we believe is significantly above foot-and-ankle peers, encouraging adjusted EBITDA progress, and continued gains across our key operating metrics, reaffirming once again that we have the right strategies in place to expand the market penetration of our differentiated technologies. Before I go into details about the quarter, let's start with our market summary on where we stand today. Our disruptive Lapiplasty solution was specifically developed to correct the root cause of the bunion and address a large and underserved market. We've identified an estimated addressable $5 billion U.S. market of an estimated 1.1 million annual surgical candidates, of which only 450,000 undergo bunion surgery each year, which we believe is mainly due to limitations associated with current standards of care. We believe our proprietary Lapiplasty system addresses these limitations by surgically correcting all 3 planes of the bunion deformity and securing the unstable joint, thereby addressing the root cause of the bunion. As of third quarter 2023, we've penetrated approximately 6.3% of the estimated 450,000 annual surgical bunion corrections in the U.S., up from 5% in the third quarter of 2022 and reflecting approximately 2.6% market penetration of the estimated 1.1 million annual U.S. surgical candidates that constitute our $5 billion-plus total addressable market in the U.S. In addition to the large and underpenetrated market for treating bunions, late in the quarter we also initiated commercialization of several new technologies, including our SpeedPlate fixation platform, Hammertoe system, and our LapiTome and RazorTome sterile instruments. And later in Q4, we'll begin commercialization of our Micro-Lapiplasty instrumentation. All these new technologies are expected to meaningfully expand our addressable market opportunity and to include additional procedures that complement our proprietary Lapiplasty and Adductoplasty procedures and fuel strong growth for years to come without diluting our focus. We're particularly excited about the opportunity for our SpeedPlate fixation platform. I'll cover SpeedPlate in more detail later in my remarks, but this is an exciting launch for our company. In fact, I believe this is one of the most important launches to date for Treace. These new product introductions are expected to begin contributing to our growth profile this quarter, with a more meaningful contribution expected in 2024 and beyond. Turning now to our Q3 results. Revenue in the third quarter was $40.8 million and grew 23% over prior year and was impacted by prioritized travel and vacations for our patient demographic, which led to lower-than-anticipated demand for our Lapiplasty procedure during the quarter. You'll also recall that we grew 53% in Q3 of last year and with 1 less selling day this year, this makes for a tough comp. We continued to advance our key performance metrics in the third quarter, including substantial gains in the number of new surgeon users, ending Q3 with 2,691 active surgeon users, up 110 for the quarter and up 21% year over year; a year-over-year increase in trailing 12-month surgeon utilization with an average of 10.6 kits per active surgeon in Q3, up from 10.1 kits a year ago; and record blended average selling price of $6,311 per Lapiplasty kits sold in the quarter, up 9% over prior year and driven by continued market adoption of our S4A Lapiplasty plates, Adductoplasty, and our other problem-solving complementary products such as our SpeedRelease and TriTome sterile instruments. We also saw some fairly early impact from SpeedPlate in our 2 new sterile use osteotomes in the quarter. Our strategic investments and commercial focus have continued to support the growth of our business, giving us confidence that we have a well-defined, proven and scalable commercial strategy. We are updating our full-year 2023 revenue guidance to $182 million to $186 million, which at the midpoint reflects an increase of 30% over 2022 revenue. There are 2 main reasons that are driving this guidance change: first, our year-to-date surgeon count is lower than anticipated due to prioritized travel and vacations from our patient demographic that started in the second quarter and continued through most of the third quarter. As a reminder, we typically see a large step-up in Q4 bunion procedures which concentrate heavily at year-end, primarily due to insurance deductibles being met. Second, we also made the strategic decision to further refine our SpeedPlate platform, extending our timeline to achieve full commercial supply until the first quarter of 2024. This decision has enabled us to make a generation 2 SpeedPlate technology which is more broadly applicable across a greater range of clinical applications, which we believe will expand our footprint in the foot-and-ankle market. Shifting to our commercial and market development activities. As we previously discussed, we have continued our targeted investments in 2023 with the goal of increasing our market penetration by expanding the footprint and coverage of our bunion-focused direct sales channel, advancing our patient awareness DTC initiatives, and driving more targeted R&D innovations into the market. We have a highly-specialized team at Treace, including a rapidly growing direct sales force, one that's 100% focused on bunion and related midfoot surgery, the only such organization that we're aware of in the U.S. MedTech industry. We believe this has contributed meaningfully to our revenue and market penetration over the past years. In the third quarter, 81% of our revenue was generated by our direct sales force, up from 74% in the same period last year. We continue to see increasing productivity from our direct reps that we added during 2022, and as we've discussed in the past, our historical data demonstrates that our direct reps typically scale with significant revenue and cost leverage achieved within 24 months, primarily because they're exclusively focused on our expanding offering of technologies and fully utilize our suite of corporate resources and programs. Further, over the past 1.5 year, we have aggressively invested in our direct sales channel. As of our last earnings call, we achieved our full year target of having 200 quota-carrying direct reps in the end of Q2, which was much earlier than originally planned. We continue to hire more additional reps to ensure that we're prudently balancing growth and delivering modest improvements in expense leverage, all while increasing revenues from our direct sales channel. Demand for our introductory and advanced surgeon education and training programs, both online and in person, remains robust, and we look forward to executing additional training sessions that we have slated in Q4. These programs play a key role in effective onboarding of new surgeon users through introductory Lapiplasty courses and also, importantly, introducing them to our complementary procedures and technology through our advanced training courses. By doing this, we are becoming a broader solution provider to our surgeon customers and expanding our footprint in the foot-and-ankle market. We're encouraged to see continuing growth in our active surgeon base with 2,691 active surgeons in Q3, which is up 21% from the prior year period. Notably, new surgeon additions ramped up substantially in September, which matched the company's all-time record for the highest number of monthly surgeon adds. As our surgeon base continues to develop and gains tenure, we anticipate utilization gains with increased use of our Lapiplasty and Adductoplasty systems, as well as further adoption of our growing portfolio of complementary products, all supported by our expanding direct sales channel, differentiating clinical datasets, and patient awareness DTC initiatives. Now I'd like to turn to our new SpeedPlate fixation platform. During September, we announced that we received FDA 510(k) clearance for our second-generation anatomic SpeedPlate design and initiated our early launch activities. Again, our SpeedPlate fixation technology is designed for rapid surgical insertion while providing both stabilization and dynamic compression of the [prepared] joint surfaces during healing. Early feedback on our gen-2 SpeedPlate design has been overwhelmingly positive with users, highlighting the speed of application and the dynamic bone compression as well as broad versatility across Lapiplasty, Adductoplasty, as well as many other common procedures involving stabilization and fusion of the bones in the foot. We believe this technology is now allowing us to attract a new audience of surgeons, those that prefer nitinol staples, which provide dynamic compression of the fusion site. I can't overemphasize how important this launch is for our company and the favorable reception that SpeedPlate has already garnered from surgeon users. In fact, we've had many surgeons tell us that the SpeedPlate implant is, "the biggest thing from Treace since Lapiplasty" and a "total gamechanger." We expect the SpeedPlate launch to begin supporting our growth in Q4 and to continue to accelerate through 2024 and beyond. We believe our SpeedPlate platform has the ability to set the standard for fixation in bunion and midfoot corrections and over time achieve broad adoption across many other common bone fusion procedures in the foot-and-ankle. We look forward to bringing this exciting technology to many more surgeons and their patients in the months ahead. Next our Micro-Lapiplasty system. This is an advanced instrumentation option designed to further reduce both the incision size and related tissue dissection with the Lapiplasty procedure. This exciting evolution of our instrumentation allows the patented Lapiplasty procedure to be performed now through a 2-centimeter incision. We anticipate the launch of our Micro-Lapiplasty instrumentation to begin late in the fourth quarter and will continue to build during the first half of 2024. We're excited about the potential benefits this Micro-Lapiplasty and SpeedPlate combination could bring to patients. As with any procedure that involves smaller incisions and less tissue dissection and trauma, we believe this could translate to even faster recovery with less pain and less swelling. We also initiated the launch of our new Hammertoe Fixation System. This is a sterile pack procedure kit that expands our reach into the high-volume hammertoe correction space. With no prior such offering in our portfolio and approximately 700,000 U.S. procedures per year, we believe this launch positions us positively for additional blended ASP growth, surgeon utilization expansion, and continued above-peer revenue growth. Though still early in our limited launch, surgeons who have had the opportunity to use it clinically have commented on its ease of use and have expressed a clear willingness to adopt our implant in their Treace cases. We estimate that approximately 30% of all bunion procedures involve simultaneous hammertoe correction, which is why we believe this represents an important addition to our portfolio that will support continued compelling revenue growth over time. While we're very excited about the growth opportunity that all of these product launches represent, there's even more to come from our robust product development pipeline. In fact, inclusive of the launches I've just discussed, we have 10 new innovation launches slated for over the next 12 months. We'll provide additional updates on our new product innovations as we continue to develop our pipeline centered around our core technologies and IP aimed at improving surgeon user experience, patient outcomes, and supporting continued market penetration. In closing, we've made encouraging progress in the third quarter with solid execution from our talented team of employees. We're at the beginning of what we believe will be a strong cadence of new product launches, as well as cause for real excitement with our new SpeedPlate platform and our other emerging growth drivers still to come in 2024. With accelerating additions to our surgeon base, increasing productivity of our direct sales channel, and several new technologies that are already starting to make a positive impact on customer demand, I'm confident that we have the right strategy in place to outpace our competitors, drive continued market penetration, and deliver strong top line growth for the remainder of this year and beyond. With that, I'll now turn the call over to Mark to review our financial performance. Mark?

Thank you, John. Good afternoon, everyone. Revenue for the first 9 months of 2023 was $124.9 million, representing 36% growth over prior year. Third quarter revenue was $40.8 million, a 23% increase compared to prior year. Growth in the third quarter was driven by increases in procedure volumes and increases in blended average selling price. In addition to the tough comp from last year that John mentioned, this quarter included 1 less selling day than Q3 2022. We sold 6,459 Lapiplasty procedure kits in the third quarter, a 13% increase compared to the same quarter last year, and was impacted by prioritized travel and vacations for our patient demographic, which led to lower-than-anticipated demand for our Lapiplasty procedure in the quarter. Blended average selling price in the third quarter was a record $6,311, up 9% over the third quarter of 2022. This blended average selling price is driven by Lapiplasty and the additional contribution from our expanding portfolio of complementary products, such as our Adductoplasty system, sterile single-use instruments, and some very early impact from SpeedPlate and Hammertoe, as our direct sales channel continues to increase their procedure access across our surgeon customers. Gross margin was 80.4% in the third quarter of 2023 compared to 81.6% in the third quarter of 2022. The 120 basis point decrease was primarily due to changes in product mix, an increase in inventory provisions, and an increase in overhead due to headcount to support the growing business partially offset by lower royalty rates. Total operating expenses were $50.6 million in the third quarter of 2023 compared to total operating expenses of $38.3 million in the third quarter of 2022. The increase in operating expenses reflect strategic investments in our expanding direct sales channel, investments in product innovation, increased capacity requirements, as well as support for other commercial initiatives. Third quarter net loss was $17.5 million, or $0.28 per share, compared to a net loss of $12.1 million, or $0.22 per share, for the same period of 2022. Adjusted EBITDA was a loss of $9.2 million in the third quarter of 2023 compared to a loss of $8.6 million for the same period in 2022. Cash, cash equivalents, marketable securities, and investment receivable totaled $128.2 million as of September 30, 2023. Our total available access to liquidity, including our debt facility, is approximately $214 million. We believe we have a lengthy runway in terms of our current cash level with sufficient balance sheet strength and flexibility to continue aggressively executing on our strategic investments and growth initiatives, as well as a clear pathway to achieve positive adjusted EBITDA. Before concluding, let me turn to our outlook for full year 2023. We are updating our full year 2023 revenue guidance to $182 million to $186 million, which at the midpoint reflects an increase of 30% compared to 2022 revenue. With less than 2 months remaining in the year, this is realistically where we expect the year to land and feel comfortable at the midpoint of the range. As John mentioned, this guidance reflects our year-to-date surgeon count and our extended timeline to achieve full commercial supply of our gen-2 SpeedPlate technology in Q1 of 2024, both of which are expected to affect our revenue as we enter the fourth quarter, which is historically our highest volume quarter for bunion surgery. Also keep in mind that this year the fourth quarter has 1 less selling day, and specifically the month of December, which is typically when we generate our highest average daily sales of the year, has 2 less selling days. Moving to the rest of the P&L. We are starting to see leverage down the P&L and expect R&D and G&A expenses in Q4 to be roughly in line with Q3 and expect positive adjusted EBITDA in the fourth quarter of 2023. For the full year 2023, we continue to expect to show modest improvements in adjusted EBITDA compared to 2022. One final item. I'd like to provide some directional comments on 2024. As is our normal mode of operation, we will provide formal 2024 guidance on our Q4 call. However, I wanted to provide you with some thoughts to keep in mind as you begin to develop your 2024 models. Overall, we expect our expanding commercial capabilities, continued adoption of Lapiplasty, and multiple new product launches will drive strong growth while we also advance our pipeline opportunities. We believe our product portfolio, differentiated and protected technologies, and focused salesforce provide us with the advantages that will enable us to grow significantly faster than market and our foot-and-ankle peers for multiple years. As we look specifically to 2024, we expect to benefit from a positive contribution from a full year of recent new product launches, including SpeedPlate, Micro-Lapiplasty, and Hammertoe, continued market adoption of the Adductoplasty technology, as well as increased contribution from the sales rep additions that were made throughout 2023. In addition, in the back half of 2024, we anticipate adding preoperative planning and patient-specific instrumentation from our acquisition of RedPoint Medical. We also look forward to launching a significant new product platform that we believe will expand our market opportunity, accelerate our penetration, and further advance our leadership position in the bunion market. We believe both opportunities will complement our business strategy and bolster our multiyear growth plans without losing focus on our core bunion and related midfoot procedure growth. Our blended ASP has historically grown mid-single digits and given ongoing surgeon adoption of Lapiplasty, complementary products and procedures, and future pipeline opportunities, we expect this trend to persist. With regard to new surgeon additions, we believe adding approximately 250 to 300 active surgeons annually is a reasonable baseline over the next few years, with utilization increases expected to drive higher procedure penetration and the tightening sales rep to surgeon ratio should support increased case coverage and adoption. These new surgeon additions and training our large active surgeon base on new procedures is expected to expand utilization and drive blended ASP increases. We expect elective orthopedic procedure seasonality trends for next year to include the typical seasonal stepdown in revenue from Q4 to Q1 and a softer Q3, followed by seasonally strong Q4, which is historically the largest revenue quarter of the year. Turning to the middle of the P&L. We expect operating leverage to continue to improve in coming quarters with potential for adjusted EBITDA breakeven for full year 2024 and positive cash flow in 2025. We will be able to provide more information on our Q4 earnings call. In closing, we made good progress in the third quarter and remain on track to drive strong growth and scale profitability in our business in the years ahead. We believe we are in a great position strategically with best-in-class bunion, midfoot, and related complementary technologies, and expanding TAM with the addition of new technologies such as Adductoplasty, Hammertoe, and SpeedPlate, and more innovation to follow. Backed by differentiated clinical data and a strong, focused commercial organization, we look forward to aggressively attacking these significant opportunities to drive the performance of the business the rest of the year and believe we have all the elements in place for a successful 2024. With that, let me turn the call over to the operator to open the line for your questions.

[Operator Instructions] Our first question comes from the line of Danielle Antalffy with UBS.

Happy to be back covering Treace. So I guess my first question is on the guidance cut by $10 million at the midpoint. And I was just wondering, Mark, if you could give any color on what's the impact of the fewer surgeons versus how you were thinking about it entering the year versus delay in SpeedPlate versus the patient travel that you called out. Is there any way to quantify what each of those components make up of the $10 million?

Danielle, it's good to hear your voice again. We've talked about in the prepared remarks, both of those elements had an impact in Q3, and both of those will have an impact into Q4. So we're not providing specific detail on which and how much that was in Q3 and Q4. But candidly, we were surprised by that summer seasonality. It was more pronounced than we had expected, and it's why the case volumes were down in Q3 and why the surgeon adds were down in Q2 and Q3 as well.

And then maybe my second question, or not maybe, my second question is actually on that point and the summer seasonality. Is there a way to give us the investor community comfort on the rebound and you modeling 45% sequential growth in Q4? I appreciate the seasonality normally, but this was a more meaningful seasonal impact from Q -- like in the summer. So what gives you the confidence that the rebound is coming in Q4? Is there something in your conversations with your treating surgeons that you could point to? I guess just how do you build that level of confidence that there's not something else going on here?

Yes. Great question, Danielle. So I think there's a couple of things. First of all, September, the first month post summer, John mentioned that we had a record for our highest surgeon adds. And so we wanted to be thoughtful as we're thinking about Q4. But we've seen that strength in September, and we've had continued strength into October as well. When you think about the fundamentals of our business, they really remain strong. And we've had really nice continued advancements in a lot of our key metrics. So it doesn't seem like that is at all an issue. It's really a strength as we go into Q4. This step up that we have in Q4 is really consistent with prior years. Q4 has always been our highest revenue quarter every year. And so we also have accelerating additions to our surgeon base, increasing productivity of our direct sales channel, and several new technologies that are already starting to make a positive impact. So with all that in mind, we considered our new updated guidance very appropriate, and we believe we have accounted for all the puts and takes that are coming into Q4. So we feel really comfortable at the end point of that range.

Danielle, it's John. I just wanted to add a little bit on top of that. We've gone through this 8 years now of concentrated procedures in Q4 and significant step-ups. I can tell you as we sit here today, halfway through what we refer to as bunion season each year, it feels right and we're glad to see it again.

Our next question comes from the line of Robbie Marcus with JP Morgan.

This is actually Lili on for Robbie. So the 250 to 300 new surgeon adds is a lot lower than what we were thinking for next year and lower than what you've done in the past. So are you expecting that same seasonality with doc adds to continue into next year? And if doc adds are going to be a lot lower, I would think that would imply a big step-up in utilization. So what's giving you that confidence to see that step-up next year?

Lily, it's John. The 250 to 300, we think that's a reasonable level. The past couple of years, if you go back, we added 500 2 years ago, 600 a year ago, both of those years we more than doubled the size of our salesforce, creating a lot of surgeon contact, we grabbed a lot of low-hanging fruit, and we're very thankful for that. We've got a lot of loyal customers now because of that. This year, we expanded the salesforce size by about 20%, and we continue to add docs at a pretty nice pace here. As with any market, the larger the customer base you try to get, you get the low-hanging fruit and then you have to climb up higher in the tree and reach for that tougher-to-get fruit. And that's what we're doing here. One of the pieces that gives us confidence is we're still continuing to build the customer base at a really nice level through this year, despite not as large of a sales rep increase. The other thing we're doing is we found that we need to be able to appeal to a broader range of surgeons, and SpeedPlate plays a very important role in that. There's a whole group of surgeons out there that have not come to Lapiplasty, not come to Adductoplasty, because they believe in a different fixation philosophy, compression nitinol staples specifically. SpeedPlate gives us an avenue into some of those docs that we've never had before. And frankly, to the record new surgeon counts we added in September, SpeedPlate did play a role, even though it was out in limited supply in bringing on some of those new docs. So for a lot of reasons, we're really confident in our ability to continue to add new surgeons. It's just that it may not be at the blistering pace that it was in the days where we were more than doubling our sales channel.

Can you just talk a little bit more about the decision to push out the full launch of SpeedPlate? Is that a supply challenge, regulatory, or is it really just to focus on getting that second-generation product ready?

Lily, yes, that's really the thing. We got out there in our limited market release, had several doctors using it, and very quickly identified things through their feedback and through our observations that we could do that would make this product more broadly appealing to a larger range of surgeons and also be able to treat a larger number of foot-and-ankle conditions, not just Lapiplasty and Adductoplasty procedures. So we found that opportunity so attractive that we did extend our timeline, we incorporated these adjustments, worked with our vendors, filed a new 510(k) with the FDA. It cost us a little time, but I think we stand by that decision. It was the right call. We saw the opportunity to make a really great product awesome and we took it. And we will be very excited and glad that we did that as we enter 2024.

Our next question comes from the line of Rich Newitter with Truist Securities.

A couple for me. Maybe just thinking about the '24 commentary and where you're jumping off from 4Q, I'm getting to about 11% to 12% 4Q implied Lapiplasty procedure growth rate, about mid-single digit ASP growth, and call it something in that run rate to get to 250 to 300, so call it somewhere in the 70 to 100 surgeon adds. If I just apply that throughout 2024, I'm getting to about a 20% growth rate with about low-teens Lapiplasty growth, mid-single digit ASP growth. I guess, is that the right way to think of the business right now broad strokes or directionally? And do we think of the weighting of the year with SpeedPlate coming next year, is that going to be a slow ramp? And it's really not until 3Q and 4Q that we see the contribution.

Rich, great question. This is Mark. Let me try to respond to that. And if I've missed anything, maybe John can help fill in. So with regards to 2024 guidance, as I mentioned in my prepared remarks, we feel like we're positioning ourselves for a really successful 2024 with our growing sales channel, all the new product launches, but we're not going to provide specific guidance on 2024 right now, although we can talk about a couple things that you mentioned. You mentioned something about the surgeon adds and how we should be thinking about that. Again, in my prepared remarks, I was saying as a baseline, 250 to 300. We've already added over 300 year to date this year. So that's 1 thing. And as we think about next year, we'll have a much, much larger active surgeon base. And so our growth can really come a lot from our existing surgeon base, and it's not as reliant on adding the incremental surgeons. Now, of course, we will continue to look for and add those important incremental surgeons, but on a larger base, we're going to make sure that all of our new products get into the hands of that existing customer surgeon base. I don't know if I hit all the points there.

Rich, John here. I think you were asking a little bit about when will SpeedPlate hit its stride or really start making an impact?

Yes, that's one of the questions. The other 2, I do think it would be helpful just thinking about mid-single digit ASP increases, level set us on active surgeon adds. I guess that would imply that you're looking at a low-teens kind of Lapiplasty procedure growth rate. Is that correct? And then, yes, how should we think of the ramp for SpeedPlate?

Okay. And maybe I'll answer them in reverse order if that's okay because I usually go to Mark on forward-guide questions. But the SpeedPlate ramp, as we exit Q4, we'll be getting into very good supply. And as we go through Q1, we'll be at full stride within the quarter. So we'll be able to satisfy all the customer demand. And that's what's got us really excited about how we're going to exit this year and ramp next year because it's a real blockbuster product for us. This is a big deal and it's very meaningful both on blended ASP, attracting new customers, and aggregating additional foot-and-ankle procedures that are outside of Lapiplasty and Adductoplasty but don't defocus our sales channel.

And with regard to Lapiplasty growth in next year, we look forward to providing additional details and guidance in our fourth quarter call. So we're just not giving too much there other than giving you an overview of some things to come.

Our next question comes to the line of Rick Wise with Stifel.

You were absolutely right last quarter when you cautioned that you were concerned about seasonality and vacation times. But I wanted to make sure that I'm understanding how we're starting the fourth quarter. We're obviously a month and a week or so in. Are you seeing the same slower trends from July, August, September, now into November with little change? Is that the major driver of the $10 million midpoint cut? I'm just trying to understand how the pieces all fit together. And that's making you more cautious. The only reason that I can't believe it's the 1 less selling day, you knew that before, and the salesforce has been expanded. If I remember correctly, SpeedPlate is delayed, but Micro-Lapiplasty and some of the other new products are, I think, in full launch this quarter. So I'm just trying to make sure I'm understanding what's driving what and to what degree that the $10 million cut at the midpoint is conservatism. Sorry for the long question.

Rick, this is Mark. And let me respond to a couple of those things. Just first, I think there's a question about some of the other products that have been available. Micro-Lapiplasty is going to come in the fourth quarter, so it's not been launched and that will utilize SpeedPlate. So that is to come. A couple of the things that I just wanted to mention, and it's what I've said a little bit before is, we were cautioning about what we were seeing in the summer seasonality. It was much more pronounced than what we had expected. And we were surveying a lot of our surgeon customers, asking them, what are you seeing as far as your volumes, case count, and your patient demographic? And just as a reminder, we have a much more narrow, specific patient demographic than a lot of other companies. And so we were asking a lot of those questions. A lot of our guide going into Q3 was based on anecdotal what we were hearing from our customer surgeon base with hopes and views that some of this softness in the summer was going to turn. Well, it just didn't turn as quickly as we had hoped, but the positives that we take away from it is, like what John said, we've had this really strong September new surgeon adds. That means they're doing cases for the first time in September. So that was very helpful and beneficial, and some of that strength has continued into October from a surgeon add perspective. So we think that's very beneficial. But as we also think about not having the number of surgeons, as you go into the fourth quarter, it was a little bit of a challenge because as we think about it, we want to have the full team, the full complement of the team going into our busiest quarter. And so, of course, not having as many surgeons on the team and using Lapiplasty will definitely have an impact. And same thing with not having launched in as aggressive of a way SpeedPlate in the third quarter, so that has pushed into the fourth quarter. And so both of those things are really informing the way we're looking at the fourth quarter. And we feel confident in the midpoint of that guide, given everything that we know so far.

Okay. And Mark, maybe you'd expand on your comments about gross margin. It was less than we thought and I'm guessing less than you expected. And talk about the specific mix drivers and the greater overhead. And I think there's a third one which I'm not remembering right this second, but to what extent does that continue into the fourth quarter and maybe just help us think in general about your gross margin thinking and how you would frame our gross margin thinking going forward.

Yes, great question, Rick. And so it was 80.4% in the quarter, and it was impacted by product mix, some inventory provisions, and when I say increased overhead, we have a growing business and employees to handle the growing volume that we have, and that was partially offset by some lower royalty rates. And so those were all the puts and takes. I would not view this as uncommon. Our gross margin will fluctuate quarter to quarter depending on some of the mix. As we introduce new products, Rick, not only SpeedPlate, but we have some other sterile instruments and other things, what we've tended to see is when at the beginning of our launches that we may not fully have all the efficiencies in our manufacturing processes available. And so it may take 1, 2, 3 quarters before we get all those efficiencies. And so it's somewhat of a mix. Are we selling some of the new products or which products are being sold or preferred by our customers? Again, we think anything north of 80% is really strong, and we feel really good about that. And we've mentioned previously that we have relatively few sellable SKUs. We have less than 50 sellable SKUs. So a mix does have an impact when you're talking about so few SKUs. But we continue to focus on our gross margins, and we plan to remain at these high levels, near or above 80%.

Our next question comes to the line of Drew Ranieri with Morgan Stanley.

Just maybe to start on my end, what essentially gives you the confidence that this is truly a seasonality aspect, and I appreciate that it might be picking up into the fourth quarter, but why are you so confident that it's seasonality and not any competitive entry or changes in the landscape becoming more of a problem in capturing surgeon mind share or any incremental procedures? And I know that we're all trying to get at maybe what utilization could look like into '24, but maybe just help us better understand what you were seeing in terms of same surgeon utilization levels in the third quarter that's giving you confidence that maybe we're not appreciating.

Drew, John here. I'll try to get to the first one first, and then Mark can remind me of the other parts. What's giving us the confidence is we did a lot of work, a lot of surveying, a lot of work with our surgeons during these summer months to figure out what the root cause of what was going on in the softness in surgery demand, and that affected new surgeons coming on. We can train tons of doctors. But if patients are coming in at a normal rate asking for a surgery, they don't get counted as a new active doctor. So we're certainly going into Q4, which is our bunion season, with a different trajectory, combining the bit of delay on the SpeedPlate, full availability, and that lower doctor count. But again, we've been through 8 years of this bunion season in Q4. It is very real. And as we sit here today, I can tell you it's back, and we're feeling it in the activity. And that's what's got us confident that midpoint is doable and comfortable. So it's a tough point for me to not express my extreme enthusiasm because I can see the other side of this as SpeedPlate comes into full availability and that continuing ramp on surgeons in utilization and what's going to come. But that's what's happened during the summer and that's how it's affecting Q4.

And, Drew, I think there's another part of your question with regards to customer utilization. That was 10.6. That's a strong utilization number. It's up more than 4% over the prior year at the same time. So it really isn't that it's a lack of utilization, per se. It was really what John talked about is there was a different patient demand for our patient demographic and that caused a few things. And then with the decision of SpeedPlate as well, pushing that out just a little bit, which was the right decision. But the combination of those 2 just had an impact in Q3 and then that's going to set us up for Q4. So that's why we felt that it's an appropriate guide for Q4, understanding those 2 items.

And, Drew, I think I missed another component of your question about competition, and we've had competition for the last several years in this space. We expected it. We created a very exciting market. The market is very big, over $5 billion in the U.S. We're way out ahead, and we've got the best technology. New entrants will continue to come into the market, but we've got a pretty powerful offense. Our rapid innovation, our focus, our direct sales channel, and then this patient advocacy that we drive through our DTC. So will competition be there and continue to be there? Yes, it has been and it will continue to. But that's not what was driving this shift. That's not what's driving the softness in the summer months. This was a real and dramatic shift in the way our patient demographic, the 30- to 60-year-old female in the U.S. behaved this year. And the headlines, you can see it all over the place. International travel, my wife was quite upset with me because I think we're the only people we don't know that didn't go to Europe at least once this year. And it was bottled up, 4 years of pre-COVID plans that all came piling into this year once the COVID restrictions left, and that demographic behaved differently probably than other companies' demographics.

And I think the final piece on that, Drew, is we stayed really close to our surgeon customer base, and we continue to ask them these questions. So that's what we're telling you is also what we're hearing from them. The same things.

And just on SpeedPlate for a moment, John. You were mentioning in your earlier remarks that this could appeal to a broader range of surgeons that believe in a different fixation system. So when you do think about SpeedPlates going into next year, will these surgeons adopt and also more broadly adopt the Treace portfolio, or do you expect them to be more siloed in one particular area of your portfolio with SpeedPlate?

Yes, great question. It very quickly, in its limited availability, found its way to be the now preferred fixation system for Lapiplasty and Adductoplasty cases for the doctors that have access to it right now. And right now only a small fraction of our doctors have access to it. And we're going to work on that quickly. But pretty quickly, we started hearing comments like, I can use this all over the foot. There are 5 or 6 other procedures that I do very commonly and routinely with your cases and outside of your cases where your rep can be there or not even have to be there. I love this fixation technology. This is a homerun, and this is the next big thing beyond nitinol technology. The combination of stability and strength of a titanium plate with the dynamic compression capabilities of a nitinol staple is an extremely attractive combination and it's a unique and first and only from Treace again. And that's why we took the extra time with it to get it as great as it possibly could be. So when we go out there with this product, our customers say, wow, Lapiplasty, Adductoplasty first and only, and now another first and only awesome product from Treace. So I think it will be adopted over time more broadly across the foot-and-ankle outside of our core procedures.

Our next question comes to the line of Ryan

Juggling a few calls tonight, so I apologize if this has been asked, guys. But I didn't hear as much on your prepared remarks around your DTC investment priorities. And I'm just wondering how you think about that in the context of driving more operating profit or adjusted EBITDA, I should say, and leverage in the model and what needs to be done to continue to maintain your position, well-balancing maybe on some of those more profitability-oriented metrics.

Ryan, it's John. You're right, we cut to the core on this script and prepared remarks and thought we'd follow up with a more detailed DTC catchup in our Q4 call. But in a nutshell, several months ago we brought on a new head of marketing with strong expertise in consumer DTC, and he's very quickly come in and been able to look at the programs we're running, fast wins, ways to optimize them, reduce even our spend and get higher output. So we're seeing some really great efficiencies on the DTC side. With less spend, we're getting higher levels of deep patient engagement and customer contact through our website and surgeon locator and call center. So we're really pleased with what's going on here. We're also, right now, very actively sponsoring the National Pickleball Championship down in Dallas. So if you're watching ESPN, you may see some...

I saw that, John. I saw that. As a budding pickleball player, thank you.

Yes. Well, Nathan is very savvy and very quickly dialed in on that demographic, which is right up our wheelhouse and a very efficient, low-cost way to get a lot of exposure and impact. So these are the kinds of things that Nathan's working on already, and I have to say 3, 4 months in, he's really on a roll and he's going to bring a lot of value to our DTC initiatives.

And Ryan, I think you talked a little bit about profitability, and I don't think -- there was a portion in my prepared remarks that talked about a potential of adjusted EBITDA breakeven in 2024 and perhaps even positive cash flow in 2025, the following year. So we've definitely started seeing leverage on the P&L already. And for the full year 2023, we continue to expect to show modest improvement in adjusted EBITDA compared to last year. So we expect operating leverage to continue in the coming quarters and into 2024.

Got it. And again, apologize. I'm juggling a few calls, so if this question has been asked, just stop me. But John, as you think about the Hammertoe product and you're expanding outward beyond Lapiplasty, has your view in terms of strategy changed at all to be more expansive in the foot-and-ankle space relative to maybe your prior views around really being focused on bunion and then adding some complementary products? it almost seems like you're following this natural pathway, but I'm wondering if your aperture has opened up a bit as you get deeper into the bunion segment and look for new markets and opportunities for growth.

No, great question and very timely. We have a high focus still on penetrating the bunion market, and we will continue to for future years. That is our sweet spot. That's where we built our direct sales channel. That's where we built our initial surgeon base and loyalty from. But now we're in a wonderful position to leverage this large direct channel that we have and start to lay in some complementary product technologies that fit into the bunion case or overlap with the bunion case to a high degree. Our Sterile Osteotomes, our Hammertoe, our SpeedPlate that can provide fixation in other areas while they're in the case that they didn't want to use a plate. So you will continue to see us expand our footprint more broadly across the foot-and-ankle market but keep laser focus on penetrating the bunion market as our spearpoint and just building around that over time.

Our next question comes from the line of George Sellers with Stephens.

Could you maybe just help clarify the SpeedPlate launch commentary? Should we read into those comments as it's still a more targeted rollout of SpeedPlate here in the fourth quarter with full commercialization in the first quarter of '24? Or is the 1Q '24 full commercialization comment referring to gen-2 SpeedPlate? And then how should we think about that relative to Micro launching this quarter?

Sure. So, SpeedPlate, the only SpeedPlate we will market is the gen-2 SpeedPlate, just to clarify that. I know it is a little confusing. That is the refined product that we've decided to build large supplies of. We will be ramping our production levels as we go throughout this quarter and then achieving full market availability within the first quarter. So we're working very hard with our vendors to get this done quickly. Just to clarify, this is not a supply chain issue. This is a change in the product configuration that we decided to make, and we had to work with our vendors to figure out how to get it achieved quickly and try not to lose too much of our revenue trajectory that we had planned for the SpeedPlate platform.

And then maybe for the 10 new technologies that you've talked about launching over the next 12 months, could you give some additional color on how many of those are maybe new devices that are attacking new foot-and-ankle deformities versus improving on and updating some of the existing devices that you currently have in your portfolio?

Yes, George, I would say the majority of them are new significant impact products, significant innovations. RedPoint technology, that's 1 of them. Something that's coming beyond that in the back half of the year that Mark alluded to will, we believe, help us expand and increase penetration into the bunion market. That's a major significant platform. And then we have a handful between call it now and the first half of the year that we'll be introducing as well.