Good afternoon, everyone, and welcome to our Third Quarter 2022 Earnings Conference Call. Participating from the company today will be John Treace, Chief Executive Officer; and Mark Hair, Chief Financial Officer. During the call, we will offer commentary on our commercial activity and review our third quarter financial results released after the close of the market today, after which, we will host a question-and-answer session. The press release can be found in the Investor Relations section of our Web site at investors.treace.com. This call is being recorded and will be archived in the Investors section of our Web site. 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. 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 and our Form 10-K for the full year 2021 filed on March 4, 2022, for a detailed presentation of risks. With that, I will now turn the call over to John.

Thank you, Vivian. Good afternoon, everyone, and thank you for joining us on our third quarter 2022 earnings conference call. In the third quarter, we continued to execute on our strategic plan with positive momentum carried through, resulting in sustained strong revenue growth and steady gains in our key operating metrics. Revenue in the quarter increased 53% and increased 51% in the first 9 months of 2022. With our investments clearly delivering on our growth, our operations are poised to scale beginning in Q4. 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 have identified an addressable $5 billion U.S. market of 1.1 million annual surgical candidates, of which only 450,000 undergo bunion surgery each year, mainly due to limitations associated with current standards of care. In the third quarter of 2022, we penetrated approximately 5% of the estimated 450,000 annual surgical bunion procedures in the U.S., up from 3.5% in the third quarter of 2021, and reflecting approximately 2% market penetration of the 1.1 million annual U.S. surgical candidates. Turning to our Q3 results. Revenue in the third quarter was $33.1 million, representing 53% growth over the third quarter of 2021. During Q3, we continued to benefit from our commercial strategies and investments with improving demand trends as the quarter progressed. Therefore, we're extremely pleased not only with our top line growth but also sustained positive trends in our key operating metrics, including our expanding direct bunion-focused sales team, which accounted for 74% of our Q3 revenue mix, coming in well ahead of our 70% target for the year. Strong, steady increases in the number of…

Thank you, John. Good afternoon, everyone. Revenue in the third quarter was $33.1 million, up from $21.6 million a year ago, representing an annual increase of 53%, driven by increases in procedure volumes and an increase in blended average selling price due to adoption of our new technologies. Third quarter revenue increased 10% sequentially over Q2. In the third quarter 2022, the number of active surgeons performing at least one case in trailing 12 months increased 39% year-over-year to 2,218 surgeons, which translates to 22% penetration of the estimated 10,000 surgeons in the U.S. who perform bunion procedures. Surgeon utilization increased to an average of 10.1 cases per year up from an average of 10 cases a year ago. This is notable. As a reminder, we commercialized Lapiplasty 7 years ago. And in the past 2 years alone, we've added 1,085 active surgeons, nearly 50% of our total active surgeon base. We are pleased with this growing number of surgeons who, on the average, steadily increased utilization each year they use Lapiplasty due to positive patient outcomes and expanding indications in their practices. We sold 5,705 Lapiplasty procedure kits in the third quarter, a 44% increase versus the prior year's third quarter. Blended average selling price was $5,794, a 6% increase over the third quarter in 2021, driven by the adoption of our Lapiplasty and Adductoplasty systems as well as early impacts from our newest technologies, our S4A plating kit, SpeedRelease and TriTome instruments. We continue to see greater uptake of our other complementary or ancillary forefoot products as we add direct sales reps who tend to focus more on selling these ancillary products well in Lapiplasty cases, displacing other competitive bunion-related forefoot products. Gross margin was 80% in the third quarter of 2022 compared to 80.4% in the third…

[Operator Instructions] Our first question comes from Robbie Marcus of JPMorgan. Your line is open.

Hi. This is actually Lily on for Robbie. Thanks for taking the question and congrats on a good quarter. Maybe just to start, so you've been pretty substantially expanding your surgeon base quarter-over-quarter. So maybe if you could just talk about how you're balancing between driving adoption in new accounts and driving deeper penetration in existing ones. And how would you compare the level of penetration in Lapiplasty share in some of those more experienced accounts versus the newer ones?

Yes. Hi, Lily, John here. I think we are focused on both fronts. Especially with our aggressive addition of new sales reps to the team, we are building new surgeon relationships. The reps are bringing new doctors to our training events, getting them up and going on Lapiplasty. And then we are also working on the other side of going deeper with our existing, more tenured users as well. And those users can be brought by the reps to advanced training courses where surgeons will learn to broaden their indications over time, and they're also impacted downstream by our patient outreach initiatives. So I think we're working on both fronts, bringing on new users and focusing on increasing utilization with our existing user base as well.

Got it. That's helpful. Maybe just a follow-up. We've seen you expand your portfolio pretty meaningfully over the last year or so with Lapiplasty -- I’m sorry, Adductoplasty and some other new products. So what sort of impact have you seen that had on Lapiplasty adoption over the last few quarters? And have you seen that have any sort of halo effect or pull-through as the portfolio has gotten bigger? Thank you.

Yes. Great question. Adductoplasty, for instance, is a great example of that. We are seeing a lot of new surgeon interest in Treace Medical products in general by offering Adductoplasty, and it just plays into this portfolio effect we are having. Having those two overlapping technologies in a surgical case, we are able to hit that in training very efficiently and seeing surgeons coming onboard to our training events with interest in Adductoplasty and other surgeons with interest in Lapiplasty, and both of them get exposed to both. And then I think our sales reps do a really nice job of rounding out the utilization to include some of our other ancillary products as they start to develop that relationship with the surgeon and the presence in the OR over time. So we are definitely having a compound effect by having these new technologies offered.

Great. Thank you.

[Operator Instructions] Our next question comes from Drew Ranieri from Morgan Stanley. Your line is open.

Hey, John and Mark. Thanks for taking the questions and congratulations on a great quarter. Maybe just to start, I know you're going to be anxious to talk about 2023, but just as you're starting to kind of think about next year, can you just help us with any puts and takes, any framework that we should be considering? I mean, you're growing tremendously this quarter, guidance moves higher. I mean it seems like you have nothing but tailwinds at your back. Looking at consensus, it looks like it's $170 million, kind of now implying 25% growth of your updated guidance number. But just are you comfortable there? And just maybe just talk about any moving pieces we should be considering for next year.

Thanks, Drew, and great topic. I appreciate the question. Yes, the way John and I have been thinking about it is, first of all, we are really pleased with the Q3 results. We put a lot of initiatives in place that are really working well, the build of the direct sales channel, some of our DTC efforts and our new product innovation. So we're really pleased where we are, and we are really tracking to expectations here. It's a little bit early to get into next year, 2023, right now when we're right in the middle of our biggest quarter here. But with that said, we really feel like we are poised to scale, as we mentioned in our prepared remarks, that we've really positioned ourselves well for this large Q4 season as well as going into next year. So we will provide more specifics in our Q4 earnings call next time, but we are really feeling good about where we are. And all the positive metrics. We talked about the number of surgeons, the utilization, the blended ASP, so we feel like we are really poised and positioned for growth next year, but we will get into more specifics next time.

Got it. Thank you. And maybe just on the [indiscernible] side, it sounds like you're going to come in a little bit above the 150 reps by year-end. But just maybe help put this in context of now talking more about being a scalable business, it sounds like you're likely going to see leverage in the fourth quarter. But how should we kind of be thinking about a broader sales force build over the next 6, 12 months even?

Yes. Hi, Drew. Thanks. This is John. I think we are very happy with what we're seeing with these new rep additions, and we've been on a very aggressive build out program this year, and we're going to continue to build that out next year. And I think what we're going to be looking for is what's that right optimum ratio of surgeons per rep. We are dialing in on that efficiency really, really well now, and we are starting to figure out where to take that, but we will continue to invest in our direct channel into next year and obviously see some scaling. And then, '24 and beyond, we will just keep tuning it and growing it appropriately.

Got it. And last one for me is just kind of following up on, I think, Lily's question earlier. But as you're thinking about these new product launches, maybe just asking this differently, I think you're 20% -- 22% penetrated in the surgeon base today, but how should we kind of think about Adductoplasty and some of these newer products maybe expanding surgeon penetration over the next 12 months or so? It sounds like it's more of a door opener for you. It might have been a barrier before by not having this product, but curious how this could really impact. And Mark, just a housekeeping question, I'm sorry, I missed the procedure kits in the quarter. Thank you.

Okay. Drew, I will grab the first side of that, and Mark can get the procedure kit number for you here. But I think we are going to continue to penetrate with Adductoplasty. We are in the early innings of this ballgame with Adductoplasty, but we have tremendous interest within our current, existing Lapiplasty surgeon user base. And then again, that combination of having both Adductoplasty and Lapiplasty in our portfolio is kind of supercharging more interest in coming to our trainings. And as these procedures compound in cases, every Adductoplasty is adding $4,000 or so on top of a Lapiplasty procedure, so we really like that. We really like what we are seeing and its impact on blended ASP. I wouldn't really say it was a barrier or not having it as a hindrance, it's another breakthrough from Treace Medical. It's the first time surgeons have had the ability to tackle a really challenging deformity of the midfoot. And so it's been just largely unaddressed. And we are giving the enabling tools, and we are coupling that with excellent advanced training so that they really feel confident doing it and then offering our clinical specialist employees that will go in on these surgeons' first 1, 2, 3 cases and be there and make sure they go really smooth. The learning curve on Adductoplasty is pretty quick relative, frankly, to Lapiplasty. So the doctor uptake on it can happen pretty quick. Again, it's never going to be the volume of Lapiplasty, but we really like the add-on capability and really the clinical problem that we are solving with this.

Andrew, with respect to procedure kits, we sold 5,705 in the quarter. So that's a 44% increase from the prior year.

Thank you.

[Operator Instructions] Our next question comes from Ryan Zimmerman of BTIG. Your line is open.

Hey, good afternoon. Thanks for taking the questions and congrats as well on a great quarter. I want to ask, John, on the fourth quarter a little bit, sorry for the near-term question. But as we think about ASPs, we try and spend a lot of time thinking about both ASPs and your doctor metrics. But if I recall, seasonally, you see maybe a more benign bunion, if you will, maybe less variability in cases in the fourth quarter just due to patients kind of achieving their deductibles earlier in the year and getting that bunion surgery done. And so I'm just wondering if you can elaborate on kind of what your product mix or your case mix index could look like in the fourth quarter as we think about ASPs in the fourth quarter.

Yes. Ryan, thanks for the question. Yes, we talked about, maybe last quarter, some lumpiness in our blended ASP quarter-to-quarter but, over time, being upward and to the right. We also mentioned that traditionally, in Q4, you get this high compression of patients, particularly in November and December, and maybe more flow to the private ASPs where they'll make a trade off and use a premium Lapiplasty kit, but maybe not our other ancillary products and that having maybe a little bit of a dampening effect on blended ASP. But I think from where Mark and I are seeing things right now, I think we are going to continue to see some good, strong, up and to the right momentum in our blended ASPs as we go into Q4. That would be our expectation as we sit here today.

That's very helpful, John. I appreciate the color. And I think it's good to note for investors. Maybe turning to the P&L for a little bit, appreciate your comments, Mark and John, about being poised to scale. But if you look at the P&L this quarter, kind of maybe where we were thinking relative to kind of what you came in at on operating expenses, on the sales and marketing line and so forth, just help us think through kind of what poised to scale really means, particularly from a spend perspective, if you could, and just how to think about kind of some of those investments that you're making.

Yes. Thanks, Ryan. That's a good question and something that we talk about regularly here. From an operating perspective, we've talked about some of the growth that we've had over the last couple of years, a lot of the investments, the growth in the sales channel, there's a lot of build there. We've also talked about expansion into a needed facility where we can do more of our sales training, our R&D development and those things, prototyping, warehousing, all of those infrastructure needs. And so this quarter reflects some of those investments, and we believe that, from that perspective, we've kind of achieved a level that will increase, but only moderately going forward from a G&A perspective. We will continue to invest in sales and marketing, as John talked about, we are focused on that build, and so that will continue into next year as well. But hopefully, that kind of helps you think about kind of the levels where we are from a G&A perspective. And we will be, of course, building and investing more in product development, so the R&D line as well. But I think a lot of the major changes have really taken place over the course of the last 12 to 18 months. So I think we're getting closer to that steadier state level.

Okay. Appreciate that, and congrats again.

Thanks, Ryan.

Thanks.

Thank you. [Operator Instructions] Our next question comes from Rick Wise of Stifel. Your line is open.

Thank you very much. I'm jumping between calls, so I apologize if my question has been asked. First, you obviously had a brilliant quarter, congratulations. But I get asked frequently about the kind of pressures we are seeing and hearing from other companies, whether it's staffing shortages of one kind or another or the consumer -- and just wondering, it's sort of silly, but you don't seem to be seeing it. How immune do you think you can continue to be in this complicated time? And maybe you could just talk around that kind of a topic, if you don't mind. Thank you.

Yes. Thanks, Rick. That's a great topic. And as a company, we are not immune from some of these macro conditions that are happening out there. But as we said in prior quarters, whether the topic was related to supply chain or different COVID strains, what we are really focused on here as a company is executing our plans, our initiatives and our strategic playbook. And so we are going to continue to do that, really keep our heads down and really focus on what those items that we have control over. And so far, it's been working for us. So we see the same things that other companies are seeing, but we believe as we are building a stronger sales force, as we are doing all those things that we've learned over the last few years work for us, we will continue to invest in those strategic areas of the company that have a return to us. So hopefully, that provides a little more color as far as where our focus is.

Okay. And as you say, you've had a number of products launched this year. Adductoplasty sort of came out of left field and was an opportunity. I'd be curious to hear where you are with that penetration, in your view. But I was wondering if you could talk a little more about what we could expect, what you're expecting from the pipeline a little bit. I missed -- again, I apologize if I missed it. If you already talked about it, we can talk about it offline.

Hey, Rick. Yes, this is John. I can hit a couple of quickies. I think we are in the early innings of the Adductoplasty conversion opportunity, first of all, very early on, lots of interest, getting more and more cases every quarter, great feedback. Our S4A plating system, just very recently released, uptake has been very rapid. It's early, but it's adding to our blended ASPs because it sells at a premium price. And then our tissue release tools, those are really nice, they're adding several hundred dollars to a good number of cases already. And we'll continue to, we think, see more upside from those as we go forward. And then as we look into 2023, we talked about earlier in the call, the micro-incision system, the instrumentation for doing Lapiplasty through a 2-centimeter or smaller incision and the potential impact that could have on quicker recovery and less swelling for patients. Then the SpeedPlate technology, which is our next-generation fixation platform, that is kind of enabling technology for micro Lapiplasty, but it's also a platform that can be used in midfoot procedures with Adductoplasty as well. So beyond that, we've got a pretty robust internal development pipeline that we will kind of have a steady rhythm of new product introductions as we go through the next 12 months, 24 months.

Got you. Thanks so much.

Thanks, Rick.

Thank you. I will now turn it back to Vivian Cervantes, Investor Relations at Gilmartin Group. Please go ahead.

Thank you, operator. On behalf of Treace Medical, thank you everyone for joining us on our third quarter earnings conference call. This concludes our call, and we look forward to our next update following the close of our fourth quarter 2022. Have a good night.

Ladies and gentlemen, this concludes today's call. You may now disconnect.