Good afternoon, and welcome. Thank you for standing by. Welcome to the Treace Medical Concepts Second Quarter 2022 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please note that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Vivian Cervantes. Please go ahead, Vivian.

Thank you, Kathy. Good afternoon, everyone, and welcome to our second 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 first 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 website at investors.treace.com. This call is being recorded and will be archived in the Investors section of our website. Before we begin, we would like to remind you that it is our intent that all forward-looking statements made during this 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 first quarter to be filed later today 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. John?

Thanks, everybody. We're pleased to report a 45% annual revenue increase in the second quarter and a 50% increase for the first half of 2022, with steady gains in our key operating metrics, driven by the underlying strength of our business and solid execution of our commercial strategies. We are also encouraged that our investments and initiatives laid out earlier this year are starting to pay dividends with our operations poised to scale. Our business is driven by our focus with a disruptive technology and surgical procedure that we believe is fundamentally changing bunion surgery today. And we're building around this with complementary technologies that address funding-related deformities such as those in the mid foot. Our continuing commitment to invest in programs to build clinical evidence and become the standard of care for bunion surgery. From what we can see in the marketplace, we're the only industry participant with a growing body of clinical data demonstrating rapid return to weight-bearing in a walking boot with low recurrence rates at 12 and 24 months and interim data demonstrating positive patient-reported outcome scores following our bunion correction procedure. Therefore, we're pleased with the sustained enthusiasm and positive momentum from surgeons through our active training initiatives as well as patients through our targeted DTC programs. Of note, our surgeon education and training programs continue to be well received with strong demand, and our regional and national seminars book to capacity for new surgeons as well as our advanced courses. As such, we're encouraged to see steady gains in our active surgeon user base. As of the second quarter, our active surgeon base, which includes surgeons who performed at least one case in the trailing 12 months, has now reached 20% penetration of the estimated 10,000 foot and ankle surgeons who perform bunion surgery…

Thank you, John. Good afternoon, everyone. Revenue in the second quarter was $30 million, up from $20.7 million a year ago, representing an increase of 45%, which was driven by increases in procedure volumes and higher blended average selling prices. In the second quarter of 2022, the number of active surgeons performing at least one case in the trailing 12 months increased 37% year-over-year to 2047, retained 20% penetration of the estimated 10,000 U.S.-based surgical podiatrists and orthopedic surgeons. Surgeon utilization increased on an average of 10.1 kits, up from an average of 9.8 kits a year ago. As our surgeon base continues to mature, we look forward to surging utilization gains with increasing use of our buy-in and related mid-foot correction systems as well as our complementary ancillary products, driven by our growing direct sales channel, DTC initiatives, and pipeline of new product innovations. We sold 5,247 Lapiplasty procedure kits in the second quarter, a 39% increase versus the prior year's second quarter. The blended average selling price was $5,711, a nearly 5% increase over the second quarter in 2021, driven by the adoption of our Mini-Incision Lapiplasty and Adductoplasty System as well as our complementary ancillary products. Gross margin was 81.1% in the second quarter of 2022 compared to 80.9% in the second quarter of 2021, a 20 basis point increase in gross margin was due to volume and operational efficiency. Total operating expenses were approximately $36.2 million in the second quarter of 2022, which includes sales and marketing expenses of $26.2 million, research and development expenses of $3 million, and general and administrative expenses of $7 million. This compares to total operating expenses of approximately $20.7 million in the second quarter of 2021, which includes sales and marketing expenses of $14 million, research and development expenses of…

At this time, we'll conduct the question-and-answer session. [Operator Instructions] Please stand by a moment while we compile the Q&A roster. Our first call is coming from the line of Robbie Marcus with JPMorgan.

Congrats on a nice quarter. Maybe to start, you had a really nice up tick sequentially in the revenue per procedure. Kits were kind of flattish quarter-to-quarter. I imagine your reps are probably starting to push. Some of the other procedures within the foot add-on to bunion surgery. How should we think about how the rep time is being spent, how they're getting compensated on adding more to the procedure? You're clearly doing a great job adding on as the revenue is moving up. And how should we think about those two metrics going forward over the balance of the year in the new guidance range?

Yes. Thanks, Robbie. Maybe I'll start a little bit on that. First of all, the way we view a lot of the revenue growth is year-over-year sequential and we're really pleased with that growth, 45% over Q2 of last year. Our sales reps are commission based. And so it's -- they're commission based on the full blended ASP that's occurred in each of these cases. And so that's another reason why we report that metric. So they're encouraged to sell the Lapiplasty kit as well as all of our ancillary products.

And how should we think about the cadence over the balance of the year of price versus volume and what's assumed in the new guidance range?

Again, with what we're talking about as far as the guidance in Q3 being consistent with what we had in Q2, that gives us a really large and year-over-year growth trend that we're very pleased with. Again, we do a lot of things during the course of the year as we prepare for a seasonally larger fourth quarter. And so we continue to do all the medical education activities and on boarding new active surgeons, which are -- we're really pleased with that. So we're poised really to benefit from all these investing activities that have been taking place in the first half of this year to the benefit from the back half of this year.

Yes. Mark's right and Robbie, I will add a little color to that. We've got a very deliberate strategy to keep refining our Lapiplasty system and offering next-generation implants that typically command a higher ASP as we're doing now rolling out our S4A plating system. We're also going to continue to keep commercializing additional bunion-focused ancillary products that will continue to contribute to that blended ASP like the Speed Release and the [indiscernible] that we just spoke about. So I think while there could be some quarter-to-quarter mix-related variability in the reported blended ASPs, we generally expect an upward trend in blended ASP to continue over time.

Great. Maybe as a follow-up, you continue to add a good amount of surgeons -- how should we think about where you stand, whether it's top quartile users or so versus, I think you said the average was 10.1% in the quarter, that maybe that was the trailing 12 month. How do we think about where some of your highest users are as we think about where the overall base may migrate to over time?

We do report that on an annual basis, the productivity of all of our surgeons based on the cohort when they started using Lapiplasty. Those that have been Lapiplasty, more than four years are doing more than 20 cases annually. And so we think it's really a large percentage of their practice, they are [indiscernible] utilizing Lapiplasty. So we know that it grows over time, and that's what, again, gives us confidence as we're adding these additional surgeons, that it's that investment that's going to pay dividends over the years.

Our next question comes from the line of Andrew Ranieri with Morgan Stanley.

Maybe just a follow-up to Robbie's question earlier. But just when you're thinking about utilization and active surgeons increasing, can you maybe go into a little bit more detail on kind of what gets you from point A to point B in terms of driving that utilization higher? Is it really all about the direct sales force? Is it about the ongoing training and education? And John, I think you mentioned that the advanced training for tenured surgeons continues to see strong demand as well as the initial demand. So can you maybe walk us through kind of that dynamic of what uptake you do see after a surgeon does an initial course and then maybe what a tenured surgeon does in there following kind of an advanced course?

Drew, great question. I don't know that we measured specific doctor activity following these events. But as a whole, our average user their first year, whether they came in January 1 or December 31 does around four cases a year. By the second year, they're doing around 7, as I recall, I could have these numbers off by 8, Mark's saying. And then by year four, they're up to 20 or so. So that's kind of the culmination of a number of things. And our entire commercial ecosystem is designed to try and accelerate that utilization curve from year one to over 20 cases quicker. So direct sales reps who call on them more, fully utilize our resources, our product innovations, and certainly, the DTC patient awareness that informs more patients to look for them on our locator and go to their office and ask for a consultation, all these kind of build on each other. And then the advanced course is really what they do, they're in a room with a lot of very experienced Lapiplasty users and maybe they're earlier on their utilization curve and just using Lapiplasty for 1/3 of their cases, but now they're in a room of faculty and surgeons that do 50%, 80%, 100% of their bunions with Lapiplasty, and they're learning the advanced technique tips and tricks and preoperative assessment and postoperative management and they're learning about the Adductoplasty procedure and how to do that along with Lapiplasty. So that sort of helps build utilization further, we believe, making them feel more comfortable and skilled at performing Lapiplasty on a broader range of their patients, and it helps drive that blended ASP, it trains them to incorporate Adductoplasty and some of these other tools into their practice.

Got it. And maybe more for Mark for this question. But with the guidance keeping third quarter sequentially flat. Just, I mean, looking at the past few years, at least as a public company, it's been at least kind of mid-single digit at least last year. So can you talk a little bit more about the flat expectation quarter-over-quarter? You mentioned seasonal softness in orthopedics, but just curious if you're actually seeing those trends today? Or is it more conservatism? Any issues with staffing shortages?

Yes. Great question, Drew. And -- we've talked about it in the past that we see the same things that other companies see with respect to some of the staffing shortages and those kinds of things. We really try to focus on what we can control, do those things that we do best growing our sales channels, our DTC programs, and patient education and all those kinds of things. And so I think we're just looking at the overall macro considerations with what's happening right now, some of the staffing shortages, -- and we also recognize that it's seasonally slower for elective surgeries in orthopedics in Q3. So when you look at what consistent with Q2 revenue would be, it's still a pretty substantial growth rate year-over-year. And that's where we're really driving the business is not really on a sequential quarter-to-quarter basis, but looking at that growth trend year-over-year. So I think it's pretty favorable if you look at it that way.

Got it. And just one last one for Mark again. But OpEx came in a bit higher than we expected, and I completely understand the investment that you're making in the direct sales force. But how should we kind of think about that about the spend into the back half of the year?

That's an important one. That's another reason why we spent a fair amount of time on this call talking about some of these investments that we've been making in the direct sales channel. We've been able to make some headway in hiring people, getting the right people, and transitioning some of our independent sales agents into [W-2] fully employed sales reps and all that [indiscernible] covers. And so we're really pleased with all that growth, and all that growth comes with some additional expenses and investment into that sales channel. We also had some increase in the DTC investments that we made in the quarter versus Q1. And so I don't think it's going to be that much different in the back half of the year from what we just saw in Q1 -- or Q2 rather with respect to those investments. But that's why we wanted to make sure that everyone knew how pleased we are with the build that we've made so far very successfully really ahead of schedule and plan. So we're pleased with all those investments.

Our next call comes from the line of Ryan Zimmerman with BTIG.

Maybe just a follow-up on -- just a follow-up to some of the other questions on Rob and Andrew. John, you talked about kind of the reimbursement for bunion surgery going up in the mid-single digits. And it's around the pricing topic. And I'm just curious if you can kind of speak to it because if I think about the pricing relative to the growth in reimbursement, I do expect average ASPs to continue to go up. But how do we think about that upper bound of pricing potential in your mind, John? I mean, how much can -- how much can it take relative to kind of where reimbursement goes? And do you think about that in that context as a percentage of the total reimbursement as you think about kind of layering on new products?

Yes, Ryan, it's John. Great question. And reimbursement is something that we pay particularly close attention to and work every year to petition and communicate with CMS, our physicians. But obviously, we've had multiple years of positive reimbursement trends in the key bunion [codes] that are involved in Lapiplasty and other codes that are other procedures performed within a typical bunion case. And a typical [bunion] case can involve five or six different CPT codes, some even more. So our blended ASP of $5,700, that's not just the bunion CPT code, that's involving other CPT codes, and we may have some lower cost ancillary products that are used in that procedure. So overall, we do keep an eye on those ratios, and we're cognizant of those ceilings that could eventually occur. But for now, we feel like we're in a pretty good situation given our portfolio of ancillary products, the CPT codes that are involved in those, which have their own separate reimbursement tied to them as well as our core bunion code and the cost of our true Lapiplasty core system. So the Lapiplasty system is not the [$5700]. It's a fraction of that and then the other is ancillary products.

Yes. No. Fair point, John. I appreciate the color there. And then as you layer on some of the ancillary products, Mark, I mean your gross margins are very strong already, but how do we think about kind of the gross margin impact of those ancillary products? And is there a potential to kind of move the dial a little bit higher on gross margins with the contribution from these newer products?

I think there are a lot of things happening all at the same time, right, with inflationary pressures and everything else, supply chain issues, and constraints. And fortunately, we've been able to manage that extremely well. So we're really focused on maintaining our gross margin in the area where it's at right now. If there are opportunities where we're definitely looking for them. Just -- it's going to be unclear -- if it's going to offset some of the other pressures or if there will be an improvement from here. But we're really pleased with where we are at and we're always looking for opportunities to increase.

I would now like to turn the call back to Vivian for closing remarks.

Thank you, Kathy. On behalf of Treace Medical, thank you, everyone, for joining us today. This concludes our call, and we look forward to seeing you at our [Surgeon Advisor] event at Nasdaq MarketSite in New York City on September 20th and also to provide you with our next update following the close of our third quarter 2022. Thanks, everybody.

This does conclude the program, and you may disconnect now.