Treace Medical Concepts, Inc. (TMCI) Q4 2021 Earnings Call Transcript

Treace Medical Concepts, Inc. (TMCI 1.85%)
Q4 2021 Earnings Call
Mar 03, 2022, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good day, and thank you for standing by. Welcome to the Treace Medical Concepts fourth quarter and full year 2021 earnings conference call. [Operator instructions] Now it is my pleasure to hand the conference over to your host today, Vivian Cervantes with Gilmartin, investor relations. Thank you.

Please go ahead.

Vivian Cervantes -- Investor Relations

Thank you, Paul. Good afternoon, everyone, and welcome to our fourth quarter and full year 2021 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 fourth quarter and full year 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 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-K for the full year 2021 to be filed Friday, March 4. With that, I will now turn the call over to John.

John Treace -- Chief Executive Officer

Thank you, Vivian. And good afternoon, everyone. Thank you for joining us on our fourth quarter and full year 2021 earnings conference call. We are pleased and encouraged by the strong fundamentals in our business in 2021.

Through our team's focus and steady investments in our commercial operations, we delivered above consensus revenue growth each quarter following our April 2021 IPO. These results were led by: an expansion of our direct sales channel that is 100% focused on bunion surgery, the only such organization that we're aware of in the medtech industry; a disruptive technology and surgical procedure that's backed by a growing body of clinical data, demonstrating both rapid return to weight-bearing and recurrence rates significantly below that of current standards of care; positive momentum from both surgeons through our active surgeon education initiatives, as well as patients through our targeted DTC programs; and steady increases in our active surgeon count and surgeon utilization rates, facilitated largely by our DTC program investments and our expanding direct sales channel. Our disruptive Lapiplasty solution, specifically developed with our Surgeon Advisory Board to correct the root cause of the bunion, addresses a large and underserved market. We have identified a $5 billion-plus U.S.

market of 1.1 million annual surgical candidates, of which only 450,000 undergo bunion surgery each year, primarily due to the limitations of current standards of care. Through 2021, we believe our market share stands at only around 3.8% of the estimated 450,000 annual surgical bunion procedures, up from 2.5% in 2020 and just 1.6% share of the 1.1 million annual surgical candidates. For 2022, our business fundamentals remained firm, and we see a long runway ahead of us. We believe we remained well-positioned for steady growth and continued market share gains ahead.

With another quarter as a public company complete, we are pleased to note continued positive market acceptance and traction with our instrumented 3D bunion surgical correction system, Lapiplasty. Our team steadily build on our momentum, continuing to invest in our strategic programs and executing to deliver on targeted financial and operational metrics. Revenue in the fourth quarter was $33.4 million, representing 55% growth sequentially, 39% growth over the fourth quarter of 2020 and at the top end of our previously announced revenue range expectation of $33.1 million to $33.4 million. For the full year 2021, revenue was $94.4 million, a 65% increase over 2020 and also at the top end of our preannounced revenue expectation of $94.1 million to $94.4 million.

Advances made in our target growth metrics include: expansion in our customer base with continued strong increase in the number of active surgeon users; continued year-over-year increases in surgeon utilization; strong blended average selling prices and growth over the prior year; benefits from our ongoing shift to direct sales, exiting the year with 58% of Q4 2021 revenue from this channel; and heightened surgeon adoption of our new products, such as the Lapiplasty Mini-Incision system, which we started rolling out in Q4 2020 and our Adductoplasty System for midfoot correction, which we launched during the third quarter 2021. We are excited for what lies ahead and believe we have the necessary levers to turn on or off in fluid response to any further disruptions, while still investing in driving growth of our business. Therefore, as we turn to 2022, we are providing full year revenue guidance of $125 million to $130 million, which reflects an increase of 32% to 38% from 2021 revenue levels. Now turning to our commercial and market development activities.

As a reminder, recurrence rates reported in the clinical literature with metatarsal osteotomy, which represents 70%-plus of the bunion surgeries today, are highly variable and have been shown to be as high as 78%. To address these shortcomings, we pioneered our proprietary Lapiplasty 3D Bunion Correction system that is designed to address the deficiencies of these traditional approaches to bunion surgery. We said in the past that a key differentiating driver for our business is our commitment to clinical evidence. To date, we believe our Lapiplasty technology is the only commercial surgical bunion solution that is supported by a strong and growing body of clinical data facilitating a steady pace of surgeon adoption and patient preference.

Interim data sets from our most advanced clinical program, the ALIGN3D multicenter prospective study, further demonstrates the durability of our surgical bunion correction. Last week, on February 25 in a podium presentation at the 2022 American College of Foot and Ankle Surgeons, or ACFAS Annual Scientific Conference, we announced the latest interim one- and two-year ALIGN3D analysis that demonstrated consistent positive radiographic and patient-reported outcomes for patients following a Lapiplasty procedure. Building upon previous interim data analysis, data on 160 study participants showed early return to weight-bearing in a walking boot at an average of just 8.5 days, significant improvement in radiographic measures of 3D bunion correction and significant improvement in patient reported pain reduction and quality of life measurements at 12 months and through 24 months, following the Lapiplasty procedure. Return to work was on average about four weeks and full unrestricted activity occurred within four months post-surgery.

And we had a continued low recurrence rate, with only one out of 116 patients reaching the 12-month time point and zero out of 54 patients that reached the 24-month time point, demonstrating a recurrence for an implied recurrence rate of 0.9% and 0%, respectively. ALIGN3D is a powerful and sophisticated study. And although the final report out with full two-year data is not expected until 2023, it is notable that this an interim manuscript received honorable mention for best manuscript at the recent ACFAS conference. We believe this indicates that our positive and differentiated outcomes are increasingly resonating with the surgeon community.

We also note strong interest for our products at the meeting, with full capacity attendance at our large-scale hands-on Lapiplasty and Adductoplasty training events. In a similar approach to ALIGN3D, we are conducting a mini 3D Lapiplasty clinical study, with our first patient enrolled in October 2021. This study utilizes patient outcomes -- evaluates patient outcomes using our Lapiplasty Mini-Incision system that utilizes a small incision approach, providing both surgeons and patients with another option to surgically manage bunion. Like Lapiplasty, the Lapiplasty Mini-Incision system is designed to realign the entire first metatarsal bone through a small 3.5-centimeter incision as opposed to cutting and shifting the bony bump, which is the case with some newer mini-incision osteotomy procedures.

Interest and sign-up for our certain training events remains active and don't show any sign of letting up. Further, our trained surgeons received strong patient interest from our DTC patient education initiatives. We also offer evergreen learning for our surgeons through our regular calendar of advanced training events, both online and in-person, where our tenured surgeons can acquire advanced skills, as well as our new approaches like our Mini-Incision and Adductoplasty system. During 2021, we accelerated investments in patient education DTC programs, expansion of our direct sales channel and R&D innovations that resulted in continued revenue expansion and momentum through Q3 and Q4.

We are more bullish than ever about the positive impact these investments are making on our business. We have a well-defined and proven commercial strategy that's clearly working. As such, for 2022, we intend to increase the targeted improved investments that produce this momentum for us in 2021 in an effort to accelerate our penetration and share of this large market over the long term. Specifically for 2022, we've made deliberate and strategic decisions to invest in growth initiatives that we expect will accelerate patient awareness, surgeon education and demand for our novel Lapiplasty procedure; expand the footprint and coverage of our bunion-focused direct sales channel and drive more R&D innovations into the market.

And as previously discussed, we will continue to support our innovative products through continued investment in building a highly differentiated body of clinical evidence. Over the past several years, we've incrementally made important investments to our patient awareness and education efforts. This has resulted in a comprehensive DTC program that leverages highly targeted direct-to-patient education to help raise awareness of our products directly with prospective patients via social media, Google search, PR and other media, including targeted TV campaigns in select markets, all of which are designed to encourage patients to seek more information and education on our patient website, locate Lapiplasty surgeons in their market and ultimately schedule a surgical consultation. This initiative has played a key role in the early growth and success of Lapiplasty, and has become an integral and cost-effective component of our commercial strategy, contributing meaningfully not only to our unique customer experience, but also an increasing patient awareness and adoption and increasing surgeon utilization.

In 2022, we plan to increase our focused investments in our DTC programs to drive broader patient awareness for our innovative Lapiplasty procedure. We know through both hard metrics from our Lapiplasty patient website and direct surgeon feedback that our DTC programs not only increase patient awareness and access to Lapiplasty surgeons, but they also motivate other surgeons to become future users of Lapiplasty. As mentioned, Treace is the only company that we are aware of, with a direct expert sales channel focused solely on bunion surgery. So as we began to invest in this channel in our early years, we carefully developed performance data and metrics over time that support ROI, particularly as our sales -- direct sales reps increase productivity in their territories, which typically scales up within 24 months, helping drive market share gains.

Our channel analytics show that, on average, relative to our independent agencies, our direct reps penetrate their markets faster, generate higher surgeon utilization levels and so at a higher-blended ASP, primarily because they're 100% focused on Treace products and fully leverage our corporate resources and programs. With increased confidence in this commercial strategy, combined with positive surgeon and patient adoption trends, we expanded our direct sales mix from 35% of revenue in 2020 to 58% of revenue in Q4 of 2021. During 2021, we started the year with 34 quota-carrying direct sales reps and more than doubled that group exiting 2021 with 81 direct quota-carrying sales reps, adding in associate direct sales reps, field sales managers and a clinical specialist to our overall quota-carrying rep count, we ended 2021 with a total fleet in the field of 144 W-2 sales employees, and this is up from 66% in -- I'm sorry, 66 employees in 2020. In 2022, balanced against strong contributions from our high-performing independent sales agencies, as well as our sales organization steadily matures, we will continue the strategic investment to further expand our sales team in the field, with a goal of approximately 150 quota-carrying direct sales reps onboard by the end of 2022.

We expect that this growing direct sales channel will continue to contribute to a higher proportion of our overall revenue in 2022 and beyond. As such, with the accelerated direct channel investments initiated in the second half of 2021 and that will continue through 2022, we now expect 70% of our revenue will come from this bunion-focused direct sales channel by the end of the year 2022. With that said, we continue to guide for the business to be modeled with active surgeons and surgeon utilization, which reflect the commercial growth of our business. Shifting now to R&D and our product development strategy.

We are committed to driving innovation with activities that include: R&D programs for both next-generation bunion correction systems, as well as the development of new technologies addressing concomitant conditions and IP events of our technology innovation. To date, we have a global portfolio of over 40 granted patents, including 32 patents granted in the U.S. Our R&D programs have yielded advancements in the procedural aspects of Lapiplasty, and our focus on the bunion pathology has highlighted other meaningful bunion-related product opportunities along the way. For example, our Lapiplasty Mini-Incision system provides both patients and physicians of minimally invasive option for our instrumented Lapiplasty procedure.

And our Adductoplasty Midfoot Correction System addresses concomitant midfoot deformities that can occur in up to 30% of bunion patients. To date, we are highly encouraged by the favorable response received from the surgeon community for both of these novel products. 2021 R&D investments have led to several new product innovations, some of which were announced last week at the ACFAS conference. At our booth at the ACFAS, we featured our Lapiplasty three-in-one guide, which is an advanced instrument specifically designed in part of our efforts to continuously advance the speed and reproducibility of the Lapiplasty bunion correction procedure; an expansion of the Adductoplasty System, which adds several specialized instruments designed to improve the efficiency and expand the clinical application of the system; and a Lapiplasty S4A Anatomic Plating System, our next-generation in Lapiplasty titanium plate fixation technology that provides surgeons with an additional fixation option; and our SpeedRelease and TriTome Release instruments, which are new single-use specialized cutting instruments, as either provide a more reliable and complete surgical release of key soft tissue structures commonly addressed during the Lapiplasty and the Adductoplasty procedures.

To clarify, some of these products are under early commercial rollout today and others we anticipate will begin rolling out in Q2 of this year. We see continued opportunities to develop additional trategic innovations for bunion and related pathologies. With our unique corporate focus on the bunion pathology, we're learning more every quarter, and see more meaningful product opportunities today than we did a year ago. Our R&D teams remain closely aligned with our Surgeon Advisory Board and have solid clinical relationships with other key surgeons across the country, both MDs and podiatrists.

Therefore, given the opportunities we've identified, we intend to increase our R&D investments in 2022. We believe our approach, particularly given our strong partnership with surgeons who provide us timely and market-leading feedback, will continue to pay dividends over the coming years. In closing, we're more bullish than ever before about the opportunity ahead of us and have built an organization and plan to establish Lapiplasty as a standard of care. As we thoughtfully invest in our proven growth initiatives, we remain focused on maximizing long-term share capture and top-line growth.

With that, I'll now turn the call over to Mark to go over our financial performance. Mark?

Mark Hair -- Chief Financial Officer

Thank you, John. Good afternoon, everyone. Revenue in the fourth quarter was $33.4 million, an increase of 55% over the third quarter 2021 and up from -- over the third quarter of 2020 and up from $24.1 million a year ago, representing an increase of 39% over the fourth quarter of 2020. Revenue growth was led by our expanded surgeon base and higher utilization rates, which grew the number of Lapiplasty procedure kits sold.

In addition, we saw continued favorable average selling prices in the quarter compared to the prior year. In the fourth quarter 2021, we sold 6,235 Lapiplasty procedure kits, a 35% increase versus the prior year's fourth quarter. Blended average selling price in Q4 was $5,363, a 3% increase over the fourth quarter in 2020 and a slight decrease from Q3 of this year. The number of active surgeons performing at least one case in the trailing 12 months in the quarter increased 40% year over year to 1,783, while utilization increased 13% year over year to an average of 9.8 Lapiplasty procedure kits per active surgeon in the trailing 12 months.

For the full year 2021, revenue was $94.4 million, a 65% increase over 2020 and also at the top end of our preannounced revenue expectation of $94.1 million to $94.4 million and our prior 2021 revenue guidance range of $90 million to $95 million. We sold 17,490 Lapiplasty procedure kits for the full year of 2021, a 57% increase versus the prior year and a blended average selling price of $5,398, a 5% increase over prior year. Gross margin increased to 81.1% in the fourth quarter of 2021, compared to 78.9% in the fourth quarter of 2020. The 2020 basis-point gross margin expansion was due to increases in the number of Lapiplasty procedure kits sold, increases in the blended average selling price and operational efficiencies.

For the full year 2021, gross margin was 81.1% up from 78.3% in the full year ago period, with the improvement led by increases in blended average selling price and operational efficiencies. Total operating expenses were $32.7 million in the fourth quarter of 2021, including sales and marketing expenses of $22.3 million, R&D expenses of $3.4 million and G&A expenses of $7.0 million. This compares to total operating expenses of $15.4 million, including sales and marketing expenses of $11.4 million, research and development expenses of $1.9 million and general and administrative expenses of $2.0 million in the fourth quarter of 2020. For the full year 2021, operating expenses were $93.1 million, compared with $44.0 million in the prior-year period.

The increase in operating expenses reflect investments to support our growing business, commercial initiatives, as well as increased cost of public funding. Fourth quarter net loss attributable to common stockholders was $6.6 million or $0.12 per share, compared to net income of $2.4 million or $0.05 per share for the same period in 2020. Full year 2021 net loss attributable to common stockholders was $20.7 million or $0.43 per share, compared to a net loss of $4.3 million or $0.12 per share in 2020. Cash and cash equivalents were $100.5 million as of December 31, 2021.

We continue to evaluate opportunities to further strengthen our balance sheet, including measures that improve our liquidity and reduce our cost of capital. Before concluding, let me turn to our outlook for full year 2022. As John mentioned, we are providing full year 2022 revenue guidance of $125 million to $130 million, which reflects an increase of 32% to 38% from full year 2021 revenue. We remain encouraged by the underlying strength and momentum of our business.

Please note that for the first quarter 2022, consistent with prior years, we expect a sequential revenue decrease from the fourth quarter due to normal seasonality coming off our usual strong year-end performance. Turning to the middle of the P&L. As John mentioned, we remain poised for continued investments in our business in 2022 in order to help position us for growth and market share gains in the coming years. We anticipate investments in sales and marketing, as well as R&D to build upon levels seen in the fourth quarter, beginning with the first quarter 2022 and as the year progresses.

With that, let me now turn the call over to the operator to open the line for your questions.

Questions & Answers:

Operator

Thank you. [Operator instructions] Your first question comes from Robbie Marcus with J.P. Morgan. Please go ahead.

Robbie Marcus -- J.P. Morgan -- Analyst

Oh, great. And congrats on a good quarter. 

Mark Hair -- Chief Financial Officer

Hey, thanks, Robbie.

Robbie Marcus -- J.P. Morgan -- Analyst

Hi. So maybe to start, as we think about the guide, how do we think about volume growth versus revenue per procedure growth? And then, second part of that question is, once again, this is a market that stay typical for medtech. How do we think about the phasing of it throughout the year?

Mark Hair -- Chief Financial Officer

Yeah, thanks, Robbie. What we just showed and what we just reported was increases in a few things. One is our active surgeon base, and that's a primary focus for us. And we also reported increases in the utilization for those surgeons.

And so, that also remains a focus for us. And we believe that those two metrics are really key to forecasting revenue for us. And so, we remain focused on really both, to adding incremental active surgeons throughout 2022, as well as all of the commercial programs that John was talking about, which we believe will also have an impact on the utilization. So it's going to be both.

We are going to add surgeons -- active surgeons, as well as continue to have higher utilization when that comes as our surgeons become more tenured and utilize Lapiplasty more frequently.

Robbie Marcus -- J.P. Morgan -- Analyst

Great. And one more from me. How do we think about -- we hear a lot of your competitors out there saying they have the latest and greatest. We saw Johnson & Johnson do a very small deal.

What are you seeing when you go out in the field? Are you getting pushback from doctors that are trained on Lapiplasty and switching to other competitors? And is it still very much an open market against surgery versus other procedured innovations? Thanks.

John Treace -- Chief Executive Officer

Yeah, hi, Robbie, John here. Yeah, there are a couple of other competitive systems out there now. J&J acquired CrossRoads. They're a company we've been familiar with.

We noted them as a competitor in our S-1. Not sure how much real traction they have out there or how much of their overall revenue is related to the bunion products, but clinical evidence would be a question. But others -- we have a very large sales channel now that we've built up that 100% focuses on Lapiplasty. We've had over six years of commercial fine-tuning with the procedure, a very broad patent portfolio to protect our innovations.

And we're the only system out there with meaningful clinical data. And it was really rewarding to see the ACFAS society award that podium presentation with an honorable mention especially at this early stage of the study. So we feel really great about our ability to keep driving our growth over the long term and how innovating data in and out, channeling anybody else out there that wants to try to get in and bite at our ankles. For some of those folks, the more they talk us up, the more they just validate us.

So we're feeling very good about our prospects for long-term growth, even with a couple or a handful of other companies trying to get into the fray here.

Robbie Marcus -- J.P. Morgan -- Analyst

Great to hear. Thanks a lot.

Mark Hair -- Chief Financial Officer

Thanks, Robbie.

Operator

Your next question comes from Drew Ranieri with Morgan Stanley. Please go ahead.

Drew Ranieri -- Morgan Stanley -- Analyst

Hi, thanks for taking the questions. I just wanted to talk about utilization for a moment. And I kind of remember during your IPO process, you had a chart talking about different levels of surgeon utilization over their tenure of using Lapiplasty. I was just kind of curious kind of what you're seeing now toward the end of 2021 into 2022? Kind of where are you seeing the most significant increases in your surgeon tenures utilization rate? Is it coming more from the experience stock? Or are you actually seeing maybe more of an acceleration and traction among the surgeon groups as there's been more data or as there's been more experiences? Wondering if you could help us out there.

Thank you.

John Treace -- Chief Executive Officer

Oh, yeah, hey, Drew, it's John. Thanks for the question. As we track the utilization by tenure or by years that they've been performing the procedure, it's a pretty steady climb all the way from Year 1 to Year 5. Some of those that I would say -- between Year 4 and 5, there's a pretty good jump as they reached very high levels of certification on our patient website.

And they really have seen, in their own practice, the long-term great outcomes from the procedure. So -- but it's a pretty steady climb throughout the curve from Year 1 up to Year 4, and then a little bit of a extra jump in Year 5. That's a smaller population base of surgeons. So some really early on surgeons in that category, too.

Mark Hair -- Chief Financial Officer

Hey, Drew, this is Mark. Just maybe one other piece to that. The benefit of doing this for now several years is we have more and more data. And so, we're really not being surprised or there hasn't been a dramatic change in the last year.

So it's been -- some are predictive, and it's been very useful to us and really no surprises there. We've had some strong -- just as John said, some strong improvements year over year as that group tenures. So nothing really new or surprising from the way that continues to progress, and progress nicely for us.

Drew Ranieri -- Morgan Stanley -- Analyst

Got it. Thank you. That's fair. And maybe just on the first quarter guidance, you talked about kind of the typical seasonality.

When I kind of go back and look at our model and we only have a few years of history, but it was down 30% in 2020, down 22% in the first quarter of 2021 on a sequential basis. Just given kind of where we are with Omicron and the hospital staffing shortages and some of the other challenges, I mean, where should we kind of figure out first quarter in that range? Are you going to be toward more the 33% decline or the 22% decline? Thank you.

Mark Hair -- Chief Financial Officer

Yeah, and thanks for that Robbie. We see that there will be a decline. As we mentioned, it's going to be -- it's pretty standard. Fourth quarter is what we refer to as bunion season, and that's our strongest quarter of the year.

So there will be a step down. I think, right now, what we're guiding is for the full year. And so, as you look at kind of that full year and that percentage range that we've given, I think that should be somewhat helpful as we think about Q1 as well. And so, I don't think it will be as pronounced as a couple of years ago, that step down, but maybe we can have some more conversations about that.

Thanks, Drew.

Drew Ranieri -- Morgan Stanley -- Analyst

Thanks for taking the questions.

Operator

Your next question comes from Danielle Antalffy with SVB Leerink. Please go ahead.

Danielle Antalffy -- SVB Leerink -- Analyst

Hey, good afternoon, guys. Thanks so much for taking the question. I just had one high level and one a little bit more detailed question. Just at a high level, you're still low single-digit market share of the potential -- of the intervention sentiment, even lower than that of the potential total patient population here.

And I'm just curious, John, where you see this going over time? And what are the barriers to adoption still today? It feels like you have everything in place from a sales force to the clinical data. So what stops this from becoming standard of care in the next, call it, five years for interventions that are surgeries that are being done? And then, just one follow-up.

John Treace -- Chief Executive Officer

Sure. Danielle, I think, all the pieces that we're putting in place, we've laid a really solid foundation in place. We've been very deliberate about how we -- what about developing this business from the beginning. Our patent portfolio, our clinical data, our sales channel and DTC patient education efforts.

And I think, the foundation is getting really solidified now. And what we are wanting to do is increase the investments in those areas to try to accelerate that and get to that point where to be the definitive standard of care over the next several years. So I think, we're heading in the right direction. We are making a lot of progress.

We are trying to overcome decades and decades of installed dogma in the teaching institutions and serving curriculum that the metatarsal osteotomy should be used for 70% or more, the majority anyway of bunions. And that takes time to change. And I think, everything we're doing through our teaching programs, that we're doing with the surgeons, direct sales reps that can really stay close to these doctors and work them through that that transition, we're clearly seeing the impact in the utilization increases year over year as every year that doctors use Lapiplasty. Incrementally here, they do more Lapiplasty.

So it's working. We are just going to try to throw some accelerators on it and see if we can push to get there quicker with these investments we began in the back half of 2021, and we're going to accelerate here in 2022.

Danielle Antalffy -- SVB Leerink -- Analyst

Got it. Yeah, the physician inertia thing is real, I get it. And then, just on the investment in DTC initiatives and things like that, how do you guys measure the return on that? Or is there a way to sort of quantify how impactful that has been?

John Treace -- Chief Executive Officer

Sure. Yep. And it's something we started piloting back in early 2018. So we've been very methodical about measuring the impact of these investments, starting from a small scale and incrementally ratcheting it up year after year after year.

We have hard metrics we can get from our website based on visits, based on certain engagement that patients make. There is a questionnaire to determine if they may be a surgical candidate that they can take. They can also search for a doctor in their area. So we monitor those relative to our spend.

And we also, on the other side, we monitor our user base, our surgeon user base and we're able to survey them progressively and measure and monitor over time how many of their patients or what percentage of their patients are coming in pre-educated or pre-impacted by our DTC efforts. And we see that number climbing tightly correlated to our spend level. So between those two, we get a pretty good bearing on the impact it's having. And then, you just go to meetings like ACFAS, where I was in the booth the whole time and I would run out of digits to count, how many surgeons came up and said, "I'm ready to get trained on this.

I've had so many patients coming in asking for it. It's just amazing." So I think, you put all that together and we feel great about the investment we're making in our DTC patient education.

Danielle Antalffy -- SVB Leerink -- Analyst

Thank you so much.

John Treace -- Chief Executive Officer

Sure.

Operator

[Operator instructions] Your last question is from Rick Wise with Stifel. Please go ahead.

Rick Wise -- Stifel Financial Corp. -- Analyst

Good afternoon, gentlemen. I can't believe we haven't really talked about COVID on this call. Frankly, I was a little anxious about the fourth quarter and what you might say about '22. Did COVID present a headwind -- much of a headwind? Can you quantify it in the fourth quarter? And how do we think about your start to the year? A lot of companies have called out tough Januaries and Februaries, etc.

Any incremental color there?

Mark Hair -- Chief Financial Officer

Yeah, Rick, this is Mark, and thanks for the question. We see a lot of the same things that other companies are seeing. I think, we've really just been trying to focus on those things that we can control. Some things we just can't control.

And the things that we can control, we feel very good about. So we did see what other companies saw in the fourth quarter and enter into Q1, but we are really focused as a whole team here as we're expanding our sales force. If there are some headwinds in one region, well, let's just push harder in another region to make up for it. So we're really just trying to have -- keep our pace of growth steady throughout the country and really be down to kind of daily business each day.

And we do feel that the bunch of this is behind us, and that we feel like we're largely clearing up. And so, we're anxious to move ahead.

Rick Wise -- Stifel Financial Corp. -- Analyst

That's great to hear. And honestly, I think, you did a great job in that kind of context. I wanted to talk about both the expansion of direct reps and how it might interact -- intersect with gross margins. You're going to have -- if I heard you correctly, said we sent direct reps by the end of the year, if I'm quoting you correctly.

Please correct me if I'm not. But I would assume that it's going to be whatever it means for opex, it should mean better gross margins, correct? And you finished really strongly. How should we be thinking about gross margins in '22 and frankly, beyond given this increasing mix of direct sales?

Mark Hair -- Chief Financial Officer

Yeah, thanks, Rick, and good question. With our growing sales force, what we see and what we've already -- saw in last year as really the steady increase was underway is that there are some increased costs related to these direct sales channel, these W-2 employees. And those costs are being reflected in the sales and marketing line as a cost of selling the product. And from a total overall cost of goods sold, we're not going to give specific guidance here on what the margin is, but we felt comfortable with what we've been able to do.

There are some operating efficiencies as we get to become a larger company. And there are benefits and efficiencies. And so, we've had some gross margin expansion in 2021. But looking at the trends in 2021, you can see that the opex line item, sales and marketing has been expanding.

And that's the line item that I was referring to in part of the script where I said we are looking to grow from here. So both in the DTC initiatives, as well as that expanding DTC -- or excuse me, direct sales channel, that's where you'll see that impact. But the gross margins, we feel good about our gross margins. They've been healthy and hopefully, with the growing efficiencies and volumes that they'll remain healthy.

Rick Wise -- Stifel Financial Corp. -- Analyst

Gotcha. Maybe just last for me. Gosh, I know it's early and serve a silly question in a way, but it's sort of a two-part question. Where are we in the rollout of MiniLap and the Adductoplasty procedure? How do we imagine -- if I would ask that question in a year, how would you hope and expect to answer it? And sort of that's Part A.

Part B, in a way is, obviously, Lapiplasty continues on, you're adding these new incremental procedures, are -- is this -- are you -- is this part of going deeper in accounts? Is this persuading more people, more physicians to get trained? Is it opening new accounts? I'm just wondering how that all is working together as you drive forward as well the intersection of all those things. Thank you.

John Treace -- Chief Executive Officer

Sure, Rick. We are very pleased with the uptake. I'd say a steady progressive uptake of the Mini-Incision system into our more experienced surgeons practices. And there continues to be more interest in that system, especially as we roll out things like the three-in-one guide that make the procedure even faster and more straightforward.

I'd say we're in the third inning on that. And for Adductoplasty, we are still early in the first inning. Our initial rollout, we had limited numbers of trays. And we're a little bit tray-constrained.

We are now getting into a situation where we're going to be able to have some good supply out on the field here in the next few weeks or months. And I think, that's going to continue to grow really nicely. There's a lot of demand for adductoplasty. A lot of excitement, both at the ACFAS conference and the AOFAS meeting prior September.

So we're looking forward to getting more availability on that system out there and driving that. That's going to help -- both of those are going to help push up our blended ASP trend and our ancillary products. As we get more direct reps, I think we're going to get better penetration because we have more people that don't have other company products in their bag to offer to those cases, right? So they've got a focus on selling our product line wholly and across the board. So I fully answered your -- the last part of your question, but please ask again if I missed something.

Rick Wise -- Stifel Financial Corp. -- Analyst

No, no, that's great. And so, it's really the expanded sales force -- expanded direct sales force with more in the bag and more tools to offer for every procedure. So it is all going to work sort of synergistically if I'm saying it properly?

John Treace -- Chief Executive Officer

Yeah, that's right, and they don't have all the products yet, but we've got a really nice pipeline and that's where we're trying to -- of identified additional opportunities, and that's why we're upping our investment in R&D. 

Rick Wise -- Stifel Financial Corp. -- Analyst

Gotcha. Thanks so much.

John Treace -- Chief Executive Officer

We are still keeping tight focus on that bunion and bunion-related pathologies and staying at our home base.

Rick Wise -- Stifel Financial Corp. -- Analyst

Yep, got it. Thank you.

John Treace -- Chief Executive Officer

Sure.

Operator

As there are no further questions at this time, I would like to turn the conference back over to management for closing remarks.

Vivian Cervantes -- Investor Relations

Thank you, Paul. On behalf of Treace Medical, we'd like to thank everyone for joining us today. This concludes our call, and we look forward to our update following the close of the first quarter of 2022.

Operator

[Operator signoff]

Duration: 60 minutes

Call participants:

Vivian Cervantes -- Investor Relations

John Treace -- Chief Executive Officer

Mark Hair -- Chief Financial Officer

Robbie Marcus -- J.P. Morgan -- Analyst

Drew Ranieri -- Morgan Stanley -- Analyst

Danielle Antalffy -- SVB Leerink -- Analyst

Rick Wise -- Stifel Financial Corp. -- Analyst

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