John Treace
Analyst · JPMorgan
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 in the U.S. As our surgeon base continues to mature, we look forward to surgeon utilization gains, not only with increasing use of Lapiplasty technology but also our Adductoplasty system and the adoption of our growing portfolio of complementary ancillary products, supported by our expanding direct sales channel as well as our patient education and awareness initiatives, which we believe help patients learn about our procedures and connect them with knowledgeable surgeons. We have a specialized team here at Treace, including a rapidly expanding direct sales force, one that is 100% focused on the bunion and related mid foot surgery and represents the only such organization that we're aware of in the med tech industry. This has contributed meaningfully to our revenue and market penetration. We continue to invest in this channel and transition to a higher mix of direct revenue over time. In the second quarter, 68% of revenue was generated by our direct sales force, up sequentially from 63% in the first quarter and up from 51% just a year ago. We ended the second quarter with 123 quota-carrying direct sales [reps], a 52% increase from the 81 direct reps we had at the end of 2021. Including associate sales reps, clinical specialists, and sales management, our employed employee fleet in the field increased 40% to 202 employees in the second quarter compared to 144 employees at the end of last year. We continued to have great success building our sales team here at Treace, and we believe these new reps are joining our team because of our unique growth profile driven by our innovative technologies that are backed by strong clinical evidence and supported by our market-leading patient and surgeon education programs. Our success not only lies with recruiting new experienced reps, but also in converting some of our successful independent sales agents into [W-2] employee reps. Having ended the quarter with 68% of sales coming from our direct channel, we are already trending above our previously announced year-end goal of 70% early on here in the third quarter. In addition, given strong interest from candidates to join our employee sales team, we now expect to exceed our year-end goal of 150 [indiscernible] sales reps. Our disruptive Lapiplasty solution was specifically developed to correct the root cause of bunion and address a large and under served market. We've 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, mainly due to limitations associated with current standards of care. As a reminder, recurrence rates reported in the clinical literature with the metatarsal osteotomy procedure, which represents 70% plus of bunion surgeries today are highly variable and have been shown to be as high as 78%. In the second quarter of 2022, we believe we have penetrated approximately 4.6% of the estimated 450,000 annual bunion surgical procedures in the U.S., up from 3.3% in the second quarter of 2021 and representing approximately 1.9% market penetration of the 1.1 million annual U.S. surgical candidates, representing our $5 billion total addressable market. We are encouraged by our momentum with positive market feedback and strong execution supporting our conviction for sustained growth and market penetration. Based on our continued rapid growth, we're pleased to note that for the fourth time in the company's history, we are once again in the process of relocating to a larger headquarters facility, which will allow us the capacity to meet our increased requirements for surgeon and sales force training, R&D product innovation as well as warehousing and other infrastructure needs. Turning now to our Q2 results. Revenue in the second quarter was $30 million, representing 45% growth over the second quarter of 2021. During Q2, we continued to benefit from our commercial strategies and investments. With improving demand trends as the quarter progressed, 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 68% of our Q2 revenue mix, strong steady increases in the number of new surgeon users ending Q2 with 2047 active surgeons, up 37% year-over-year. Continued year-over-year increases in surgeon utilization with 10.1 kits per surgeon in Q2, up from 9.8 kits a year ago and strong blended average selling prices of $5,711 per case, representing 5% growth over the prior year due to positive uptake of our newer innovations such as the Lapiplasty Mini-Incision system and our Adductoplasty system for mid-foot correction and as our direct reps leverage their position in the OR and increasingly displaced competitive forefoot products with our complementary ancillary products. Investments in our patient awareness [DTC programs], expansion of our direct sales channel, and R&D innovations consistently support our revenue expansion and momentum. We remain excited about the positive impact these investments are making on our business, giving us confidence that we have a well-defined proven, and scalable commercial strategy that's fueling our growth. Given these positive trends, we are raising our full-year 2022 revenue guidance [to $130 million] -- to $134 million, which reflects an increase of 38% to 42% from 2021 revenue. Shifting now to our commercial and market development activities. A key differentiating driver for our business is our commitment to providing peer-reviewed clinical evidence to support the safety and efficacy of our products, which we believe resonates well with both surgeons and patients. In May, we announced our 21st peer-reviewed publication supporting our Lapiplasty technology. This recent article published in the Journal of Foot and ankle surgery reported on our positive interim 1- and 2-year results, including both radiographic and patient-reported outcome scores on 173 patients treated in our flagship ALIGN3D, multicenter prospective study. With our extensive and growing clinical dossier, combined with over 6.5 years of clinical use and refinement and over 50,000 patients treated as of Q2, we continue to believe that we are setting a new standard of care for bunion surgery. As mentioned last quarter and consistent with our commitment to provide meaningful clinical evidence to support our innovations -- we continue to make steady progress with our mini 3D Lapiplasty multicenter prospective clinical study. As a reminder, this study utilizes our mini-incision Lapiplasty system, which offers a much smaller 3.5-centimeter incision approach to realign the entire first metatarsal bone and address the root cause of the bunion versus just cutting and shifting the bony bump, which is the case with osteotome procedures. During Q2, we continue to treat additional patients and on board new clinical sites for this study, and we look forward to providing future interim report-outs on the Mini 3D data set. Our Mini-Incision Lapiplasty approach continues to resonate with growing interest from both surgeons and patients. We continue to see steady adoption of our Mini-incision system with positive contributions to our average blended selling prices. Interest in attendance by new surgeons at our training events were strong during the second quarter, supporting our plans for additional national and local events with expectations for continued strong participation for the remainder of the year. In addition, our advanced training events held both online and in person, where our tenured surgeons can learn new skills and approaches such as our mini-incision and Adductoplasty procedures are on schedule with strong demand throughout the year. As noted, we've been making additional targeted investments this year to accelerate our market penetration by advancing patient awareness, surgeon education, and demand for our Lapiplasty and other related procedures, expanding the footprint and coverage of our bunion-focused direct sales channel and driving more R&D innovations into the marketplace. With our site aimed at driving long-term market penetration, we're very pleased to report increasing traction and early momentum from these initiatives. Our DTC patient awareness initiatives are a key component of our commercial strategy, designed to educate patients on bunion deformities and our differentiated solution, encourage these patients to seek more information and locate Lapiplasty surgeons in their market and ultimately to schedule a surgical consultation. We employ social media, Google Search, public relations and other media, including targeted TV campaigns with strong metrics and performance data that show active patient engagement further supported by feedback from regularly conducted surgeon surveys. We believe we have a highly effective DTC strategy in place. We also have strong conviction in our direct sales force strategy and continue to make focused investments to grow our highly specialized direct field sales team. Our channel analytics continue to show that, on average, relative to our independent agencies, our direct sales reps penetrate their markets faster, generate higher surgeon utilization levels, and sell at higher blended ASPs. These direct reps typically scale with cost leverage demonstrated within 24 months, primarily because they're 100% focused on Treace products and fully utilize our corporate resources and programs. As our direct sales force matures, we look forward to driving expense leverage over time. Turning 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 ancillary products addressing [combinant] conditions and IP defense of our technology and innovations. At the end of Q2, we had 36 branded U.S. patents and over 40 U.S. patent applications pending. On August 3, we announced the full nationwide commercial release of several new product innovations previewed at the ACFAS Scientific Conference last February. These include the Lapiplasty 3-in-1 guide, an instrument designed to advance the speed and reproducibility of the lapiplasty procedure. We've been receiving excellent feedback on this product, including a recent surgeon user survey that reported an average 15% reduction in time to perform a Lapiplasty procedure when using this new 3-in-1 guide. The Lapiplasty S4A Anatomic Plating System, this represents our third-generation Lapiplasty titanium plate fixation technology and provides an advanced anatomic design to address variabilities in the TMT joint anatomy. And the speed release and [indiscernible] release instruments. These new sterile packaged specialized cutting instruments are designed to provide a more accurate and complete surgical release of keysoft tissue anatomy, commonly involved in the Lapiplasty and Adductoplasty procedures. Proper soft tissue releases are important in achieving consistent corrections of the bones involved in both bunion and mid-foot deformities. 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 continuing market penetration. Speaking briefly to reimbursement for our products. CMS has recently released its proposed 2023 Medicare payment rates for hospital outpatient and ASC services to cover facility costs for surgical procedures, which include supplies and implants used in the surgical case. As a reminder, our products are used in procedures covered by well-established existing CPT codes. And we're pleased to note that the reimbursement rates for these particular codes are slated for mid-single-digit increases in the year 2023. Assuming the proposed 2023 rates are affirmed, this will continue a multiyear trend of low to mid-single-digit increases in facility reimbursement rates for [CPT codes] associated with our procedures. In closing, I'm proud of the great execution delivered by our focus team here in Ponte Vedra, Florida and throughout the country. Based on continued positive feedback we're receiving from the clinical community, we know that we are helping improve the lives of patients suffering from painful lifestyle limiting bunion and related mid foot deformities. We are executing to plan supported by a strong balance sheet that we believe is adequate to take us into profitability and to fully fund our planned commercial market and product development initiatives. We have technologies backed by strong clinical data sets and positive reimbursement trends that are advancing the standard of care in the surgical management of bunions, a commercial strategy of proven DTC and direct sales programs that are poised to scale, and a talented team of over 330 employees with a shared passion for our mission to improve the surgical outcomes of bunion patients. With that, I'll now turn the call over to Mark to review our financial performance. Mark?