John Treace
Analyst · JPMorgan. Your line is open
Thank you, Vivian. Good afternoon, everyone, and thank you for joining us on our fourth quarter 2022 earnings conference call. 2022 was another great year of growth and execution at Treace. At the beginning of the year, we strategically increased investments into proven business strategies, namely growing our direct bunion-focused sales channel, increasing investments into our patient awareness DTC initiatives, and making targeted R&D investments in Lapiplasty innovations, as well as in our expanding suite of complementary products. These investments resulted in strong revenue growth of 50% over 2021 and realized continued gains in our key operating metrics. Our operations continued to scale through 2022, ending our seasonally strong fourth quarter with positive adjusted EBITDA. We are proud of the progress we've made and believe we've built a strong foundation that will continue to fuel our growth over the coming years. Before I go into details about the quarter and year, let's start out 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 addressable $5 billion plus U.S. market of 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. As of the fourth quarter of 2022, we have penetrated approximately 5.5% of the estimated 450,000 annual bunion surgical procedures in the U.S., up from 3.8% in the fourth quarter of 2021 and reflecting approximately 2.2% market penetration of the 1.1 million annual U.S. surgical candidates that constitute our $5 billion plus total addressable market. Turning to our Q4 and full-year results. Revenue in the fourth quarter was 49.8 million, representing 49% growth over the fourth quarter of 2021 and was slightly above the previously announced revenue range expectation of 49.1 million to 49.6 million. During the fourth quarter, we continued to benefit from our commercial strategies and investments with strong demand trends from surgeons and patients and growing sales force productivity. For the full-year 20-22, revenue was 141.8 million, 50% increase over 2021 and also slightly above the top-end of our pre-announced revenue expectation of 141.2 million to 141.7 million. Notably, our revenue growth in the second half of 2022 was above the growth rate we experienced in the same period for 2021. Therefore, we're extremely pleased not only with our top line growth, but also sustained positive trends in our key operating metrics during the fourth quarter, including our expanding direct bunion-focused sales team, which accounted for 77% of our Q4 revenue mix coming in well-ahead of our 70% target for the year. Strong steady increases in the number of new surgeon users ending Q4 were 2,387 active surgeons, which is an increase of 604 during the year, up 34% year-over-year, a year-over-year increase in trailing 12-month surgeon utilization with an average of 10.3 kits per active surgeon in Q4 up from 9.8 kits a year ago and strong blended average selling prices of $5,907 per Lapiplasty kits sold in the quarter, representing 10% growth over the prior year, due to steadily increasing contribution from our Adductoplasty Midfoot Correction System, as well as our more recently commercialized [S4A Anatomic Plating System and SpeedRelease] [ph] and our TriTome tissue instruments. Our strategic investments and commercial focus have allowed us to successfully grow our business, giving us confidence we have a well-defined proven and scalable commercial strategy. Therefore, as we turn to 2023, we are providing full-year revenue guidance of 187 million to 193 million, which reflects an increase of 32% to 36% over 2020 revenue. We look forward to balancing aggressive execution on our proven strategic initiatives to maximize our growth and market penetration with modestly improving expense leverage. Given our market differentiation and large $5 billion plus U.S. opportunity, we remain committed to our growth agenda. Shifting now to our commercial and market development activities. As discussed, we made targeted investments in 2022 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 investments 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 mid-foot surgery, and represents the only such organization we're aware of in the med tech industry. We believe this has contributed meaningfully to our revenue and market penetration. In the fourth quarter, 77% of our revenue was generated by our direct sales force, up sequentially from 74% in the third quarter and up from 58% just a year ago. We were happy to announce last quarter that we surpassed our previously communicated 70% year-end target earlier than anticipated and we expect to grow to a higher mix of direct revenue over time. We ended the fourth quarter with 168 quota carrying direct sales reps, an increase of 107% from the 81 direct reps that we had at the end of the year 2021. Given the strong interest from great candidates to join our employee sales team, we're also happy to announce that we exceeded our year-end target 150 quota carrying sales reps set forth at the beginning of the year. We believe these new reps are joining our team because of our unique growth profile and culture driven by disruptive technologies that are backed by strong clinical data sets and supported by our market leading patient and surgeon education programs. Including associate sales reps, clinical specialists, and sales management, our employee fleet in the field increased 85% to 267 sales employees in the fourth quarter, compared to 144 employees at the end of last year. We continue to experience strong benefits from our expanded direct sales team. Our direct reps typically scale with significant revenue and cost leverage achieved within 24 months, primarily because they're exclusively focused on our products and fully utilize our suite of corporate resources and programs. In 2023, we plan to continue to invest in our direct sales channel to drive increased market penetration with a target of having over 200 quota carrying direct reps by the end of the year 2023. Our patient awareness DTC initiatives are a key component of our commercial strategy. We remain focused on our patient awareness DTC initiatives that are designed to educate and steadily increase the number of potential patients visiting our website, become educated on the benefits of Lapiplasty, locate experienced Lapiplasty surgeons in their area, and ultimately for these patients to schedule a consultation. Our investment DTC is resulting in hundreds of thousands of patients visiting our website every month and tens of thousands of patients searching for a Lapiplasty surgeon in their area. Now, with one out of four surgeons in the U.S. using Lapiplasty, we have a larger and expanding national surgeon base that can field inquiries from a higher volume of patients. Given this, we believe the time is right to step-up our DTC investments in 2023, which we've initiated earlier this year than last. Our surgeon education and training programs also continue to be well-received. Interest in attendance by new surgeons at our training events was strong and oversubscribed very often in 2022. Likewise, our advanced training events both online and in-person where our more tenured surgeons can acquire advanced skills and learn new approaches such as our Mini-Incision and Adductoplasty procedures continued to show strong surgeon demand. Our education programs play a key role in the effective onboarding of new surgeon users and increasing the skills of our existing users, broadening their patient indications. During 2022, we added a record 604 new surgeons compared to 508 in the same period last year, representing a 34% increase. We are encouraged to see this continued strong growth in our surgeon user base. As of the fourth quarter, our active surgeon base, which includes surgeons who performed at least one case in the trailing 12-months, has achieved approximately 24% penetration of the estimated 10,000 Foot and Ankle Surgeons who perform bunion surgery in the U.S. As our surgeon base continues to mature, we look forward to 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 and patient awareness DTC initiatives. We were pleased to see the high level of interest and attendance of new surgeons at our training events in 2022. And it's evident that we offer a great education platform for a growing network of Lapiplasty surgeons and we look forward to hosting additional surgeon training events in 2023 across the country and in our new state of the art training facility here at our headquarters in Ponte Vedra. Speaking now to our product development strategy, we have an R&D team committed to driving innovation to maintain our industry leadership with programs for both next generation bunion correction systems, as well as the development of new complementary technologies addressing other bunion-related pathologies, and IP defense of our technology and innovations. At the end of Q4, we had 40 granted U.S. patents and over 46 U.S. patent applications pending. 2022 was a terrific year of innovation for us. Following full commercialization of our Adductoplasty system in Q2, in August, we announced the full commercial release of our Lapiplasty 3-in-1 [catgut] [ph], our Lapiplasty S4A Anatomic Plating kit, and the SpeedRelease and TriTome tissue release instruments. While still early, adoption of these products has progressed nicely, and we are encouraged by the favorable response received from the surgeon community for a growing portfolio of bunion-focused technologies. In February at the American College of Foot and Ankle Surgeons, we highlighted two new exciting product innovations, namely 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 evolution of our instrumentation allows the bunion correction and joint preparation steps of patented Lapiplasty procedure to be performed through 2 centimeter incisions, and our speed plate implant fixation platform. This is a new fixation technology platform designed for rapid insertion through small 2 centimeter incisions serving as both an enabling technology for the micro Lapiplasty procedure, but also with broader applicability to our standard and mini-incision Lapiplasty systems, as well as Adductoplasty midfoot procedures. We continue to anticipate the commercial release of these technologies during the second half of 2023. We're excited about the potential benefits this micro Lapiplasty SpeedPlate combination could bring to patients. As with any procedure that involves smaller incisions and less tissue dissection, we believe this can translate to even faster patient recovery with less pain and swelling. We look forward to providing additional updates on our new product innovations as we continue to develop our pipeline centered on our core technologies and IP aimed at improving surgeon user experience, patient outcomes, and supporting continued market penetration. Turning to clinical data. A key differentiating driver for our business is our commitment to clinical evidence, which we believe resonates with both surgeons and their patients. From what we can see in the marketplace, we believe 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 months and 24 months and interim data demonstrating positive patient reported outcome scores following our bunion correction procedure. During the fourth quarter, we announced the treatment of the first patient in our MTA 3D Adductoplasty clinical study. As a reminder, the MTA 3D study is a prospective multicenter clinical study that will evaluate outcomes of Adductoplasty combined with the Lapiplasty procedure for patients in need of bunion and mid-foot deformity correction. We look forward to providing interim updates on our MTA 3D study in the future. At the 2023 American College of Foot and Ankle Surgeons Annual Scientific Conference in February, we announced an interim data analysis from our flagship ALIGN3D prospective Lapiplasty study on 128 patients with at least 24 month follow-up, which demonstrated early return to weight bearing in a walking boot in an average of 8.1 days, a low recurrence rate of 0.9%, 80.8% reduction in pain measured using the visual analog scale or VAS at 24 months, 92% and 90% improvement in walking standing and social interaction patient reported quality of life measures respectively using the Manchester-Oxford Foot Questionnaire, or MOXFQ through 36 months and notably 97.3% patients reporting they were satisfied or very satisfied with the overall results of their Lapiplasty procedure at 36 months. We believe we're the only company to offer this level of clinical evidence on a commercial surgical bunion product and it's rewarding to see the meaningful impact the Lapiplasty procedure is making on patient’s lives not only physically, but socially as well as demonstrated by the high 97% patient satisfaction rating at 3 years' post Lapiplasty surgery. As a reminder, later this year, we expect to submit our primary endpoint ALIGN3D manuscript for publication in a peer-reviewed journal. This is a milestone culmination of activities that began five years ago with the first patient enrolled in 2018. Again, we believe the positive interim patient data coming from our differentiated ALIGN3D study resonates strongly with the surgeon and patient communities and is further reinforcing market adoption of Lapiplasty. In closing, 2022 was another strong year performance and growth for our company. We are experiencing significant momentum in all aspects of our business and have developed a specialized and scalable business model that we believe will allow us to continue to advance our growth strategy. I'm proud of the great execution delivered by our team here in Ponte Vedra, Florida and throughout the country and we remain highly and extremely excited about our future prospects as we continue to execute on our strategic plans. With that, I'll now turn the call over to Mark to review our financial performance. Mark?