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spk18: Good morning and welcome to Orthopediatrics Corporation's second quarter 2023 earnings conference call. At this time, all participants are in listen-only mode. We will be facilitating a question and answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Tripp Taylor, from the Gilmartin Group for a few introductory comments. Please go ahead.
spk20: Thank you for joining today's call. With me from the company are David Bailey, President and Chief Executive Officer, and Fred Hite, Chief Operating and Financial Officer. Before we begin today, let me remind you that the company's remarks include forward-looking statements within the meaning of federal securities laws. including the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to numerous risks and uncertainties, and the company's actual results may differ materially. For discussion of risk factors, I encourage you to review the company's most recent quarterly report on Form 10-Q, which will be filed with the SEC today. During the call today, management will also discuss certain non-GAAP financial measures, which are supplemental measures of performance. The company believes these measures provide useful information for investors evaluating its operations period over period. For each non-GAAP financial measure referenced on this call, the company has included a reconciliation of the non-GAAP financial measure to the most directly comparable GAAP financial measure in its earnings release. Please note that the non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as substitutes for other orthopediatrics financial results prepared in accordance with GAAP. In addition, the content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast today, August 1st, 2023. Except as required by law, the company undertakes no obligation to revise or update any statements to reflect events or circumstances taking place after the date of this call. With that, I'd like to turn the call over to David Bailey. President and Chief Executive Officer.
spk13: Thanks, Chris.
spk07: Good morning, everyone, and thank you for joining us on our second quarter 2023 conference call. As we start all earnings calls, I'd like to begin by highlighting that we helped a record 21,000 children in the second quarter of 2023, and since inception, we have now helped over 670,000 kids. Helping more children remains the best measure of our success. In the second quarter of 2023, we generated record high revenue of $39.6 million, representing growth of 20% compared to the second quarter of 2022. Despite a challenging operating environment within Children's Hospital, we continued growing our business by taking market share and are encouraged by the momentum we've generated in the first half of the year. We are proud to have again generated growth of 20% against the strongest comparable period of the year while deploying $9.2 million worth of sets. Altogether, we are positioned favorably for the second half of the year. As expected, we are experiencing gradual month-by-month improvements in the inpatient surgical environment where nearly all of our procedures are performed. As you may have read, many insurance companies have reported increased overall volumes but lower inpatient procedures. Our observations are consistent with this recent commentary, and we continue to feel the impacts of lower than historical average volumes in the children's hospital environment. Nevertheless, execution of our historically successful strategy is leading to consistent quarter-over-quarter share gain and is producing sustainable growth regardless of market conditions. Therefore, we are reiterating our revenue guidance of $148 to $151 million, representing growth of 21 to 23%. Moving to our revenue segment. In the second quarter of 2023, we generated total trauma and deformity revenue of $27.5 million, representing growth of 22% compared to the prior year period. Revenue growth in the quarter was led by strong performances in deformity correction and PEGA products. The quarter saw a record X6 performance from our external fixation portfolio driven by Orthex, the recently launched pre-planning software, and the new drive rail system. Defos plating system, and PD plates, a system we first launched in 2008, all were particularly strong in the quarter. Although the trauma franchise grew slightly slower than it has in the last few quarters, P&P femur and cannulated screws continued their dynamic growth trend. Additionally, PEGA product sales have been better than we ever expected, nearly doubling in the U.S., and we are just now seeing the early returns of additional deployed inventory. International Pega revenue, while strong, has yet to reach its full potential as we are working through several conversions of stocking distributors to our agencies. We expect this to become a strong tailwind and a solid source of growth in the second half of 2023 and beyond. Overall, strong Pega revenue will continue to benefit the company for the next several years, and we are very pleased with how this is trending. Speaking of Pega, in June, we announced the limited launch and first procedure using the gyro system developed by the PEGA R&D team in Montreal. This unique tethering system utilizes guided growth, providing surgeons a new way to treat limb deformities without the need for osteotomy. This system builds on our legacy of innovation and illustrates another reason why we are so pleased with the PEGA acquisition, as it strengthens the orthopediatrics R&D pipeline. Lastly, on the trauma deformity R&D side, we are eagerly anticipating the FDA approval and beta launch of our PMP tibia system, which will be a first-of-its-kind pediatric rigid tibial nailing system modeled after our market-leading and largest trauma product, the PMP femur. PMP tibia will serve as a follow-on to our largest and fastest-growing trauma product, PMP femur, and we are extremely excited about its growth potential. If we see a successful approval, we are targeting the first case late in the third quarter. Within the T&D business, our non-surgical specialty bracing business continues to perform well, highlighted by MDO clubfoot bracing. In the second quarter, the non-surgical specialty bracing business launched the clubfoot move bar, expanding the MDO portfolio, which has received a very positive customer response. We are eagerly awaiting the launch of several additional products from our team in Iowa as well as the much-anticipated DF2 femur fracture brace, which recently proceeded through final validation and is launching this month. With respect to MDO, the addition of new products in existing markets and expansion into new markets is bolstering growth. Now slightly more than a year into launch, we have validated our thesis that orthopediatrics can and will build a large and profitable business in the specialty bracing space. Our customers are presenting us with several unmet needs in the areas that can truly impact care for kids. And we're planning to further invest in R&D that can help deliver much-needed solutions. Our specialty grazing business represents the most capital-efficient opportunity for growth in our portfolio and reduces the need for continual capital deployment. While we are very early, we see this business growing to in excess of $100 million in the next several years, providing a new and exciting growth opportunity. Moving to the scoliosis business. In the second quarter of 2023, we generated revenue of $10.9 million, representing growth of 16% compared to the prior year period, driven by a continuation of our strategy of promoting the combined strength of apophix, response, and 7D placement. The second quarter started uncharacteristically slow, but dramatically improved into May. And the usual summer seasonality started to show up in June, which we expect to carry forward throughout the summer. We also expect the multiple 7D units placed in GUE2, along with our strong consignment and sales pipeline, to bolster scoliosis growth in the second half of the year. We're pleased to see the value proposition of the combination of Apifix, 7D, and response, comprehensively addressing surge in needs and driving market share gain, again, Total users in Q2 increased meaningfully compared to the prior year period. Enabling technologies such as additional 7D placement and ongoing Firefly usage is driving share gain for our response fusion platform, and Apifix non-fusion is helping expose new surgeons to all our scoliosis technology, leading to new customer acquisition. Apifix usage is growing, both in terms of new users and increases among existing users. Our scoliosis growth continues despite an absence of revenue from three of our largest sites as both surgeons have transitioned to new practice locations. We expect this will normalize in the coming quarters. We continue to make progress on the development of Apifix's non-fusion clinical data, which we believe will lead to increasing KOL support and podium presence. For example, one-year data of 148 patients was presented from the podium at Pawsman by Dr. Jeff Haft, that showed just five of 148 apophexations went on to fusion and a low device-related re-operation rate of just 6.7%. We're pleased to see these results, especially given that these are the first cases done in the US. As we learn more, work through the learning curve, and make further advancements on the implant and technique, we expect results will get even better in the coming years. Given the early data, we expect to see several additional publications in the quarters to come. On the R&D front, in Q2, we launched several key products and line extensions, including response power, response power torque, response cannulated screws, and response derotation instrumentation. During the quarter, we performed several surgeries with each of these new products and received positive surgeon feedback, with especially glowing commentary about our power system. Lastly, we continued progress on our EOS suite of products and achieve major milestones on our EOS Guided Growth System during Q2. We expect FDA submission of this key product by year end. Moving on to international. In the second quarter of 2023, we generated international revenue of $10 million compared to $8 million the prior year period, delivering 25% growth, primarily driven by strong performance with our legacy products, slightly offset by slower MDO growth due to timing of stocking purchases by new MDO distributors that were very high in Q2 of 2022. Agency market sales in Europe were particularly strong, signalizing a normalizing surgical environment, and progress in our German direct sales model is a bit ahead of schedule. We are pleased with this rebound and expect the strength to continue in the second half of this year. While small at this time, we are at the very beginning of launching our scoliosis business in Europe. and expect this to positively impact revenue as early as 2024. Additionally, sales of Pega products are just starting to contribute to revenue growth outside of the U.S. as we begin to transition stocking distributors to our agencies in 14 markets. Once complete, we expect to see very similar results to that of the U.S. and believe this will be a major tailwind to international growth in the second half of 2023 and beyond. Additionally, we've worked toward expanding our international distribution footprint, and I have a few updates to share. This quarter, we signed two new stocking distributor agreements. The first is for distribution of our scoliosis product in Brazil, and the second is an agreement to distribute the broader orthopediatrics portfolio in Peru. These distribution agreements will strengthen our international presence, and we expect them to contribute to our growth in the second half of the year and beyond. Lastly, we've received positive audit feedback related to the long process of EU MDR compliance with orthopediatrics products and expect to achieve EU MDR approval in the coming year, thus opening opportunities to launch several new to Europe products in 2024. It is our intention to have the full suite of products compliant in 2024. That brings us to surgeon training and education. To support our goal of helping advance the entire field of pediatric orthopedics, we continue to prioritize outsized support of pediatric orthopedic clinical education and training. This pillar of our strategy is central to who we are as a company, and we believe signals to our customers that we're different than our competitors. Throughout the second quarter, Orthopediatrics held over 90 events, which included training sessions and educational programs reaching over 1,200 healthcare professionals. In May, we unveiled our new Emerald sponsorship at PASMA in Nashville, solidifying our position as the leading supporter of the Surgical Society. The 2023 meeting saw record attendance, and the Society continues to grow in both membership and prominence in pediatric healthcare. Through our long-term commitment to PASMA, we are providing ongoing support of rigorous training events for surgeons and other healthcare professionals, awarding educational grants and scholarships, and have founded a Women's Affinity Group to support our combined efforts in diversity, equity, inclusion, and belonging across the subspecialty. Additionally, we hosted interactive case-based seminars to discuss novel treatment options in adolescent idiopathic scoliosis, utilizing our Apifex technology. And we celebrated our colleague and friend, retired Chief Medical Officer, Dr. Peter Armstrong, as he was inducted into the Poznan Hall of Fame. Lastly, before I turn it over to Fred, I'm delighted to welcome Dr. George Dyer to our Board of Directors. He is a renowned orthopedic surgeon at Brigham and Woman's Hospital in Boston, as well as being associate professor of orthopedic surgery at Harvard Medical School. For 10 years, George was the program director of the Harvard Combined Orthopedic Residency Program, one of the largest orthopedic residency programs in the country. His deep experience will allow him to contribute to our clinical training program, as well as our product portfolio strategy. With that, I'll turn the call over to Fred to provide more detail on our financial results.
spk10: Fred? Thanks, Dave. Our second quarter 2023 worldwide revenue of $39.6 million increased 20% compared to the second quarter of 2022. Growth in the quarter was driven primarily by continued share gains across our legacy portfolio, as well as growth of our non-surgical specialty bracing business. U.S. revenue was $29.6 million, a 19% increase from the second quarter of 2022. Growth in the quarter was delivered across our trauma and deformity product lines, including our non-surgical specialty bracing business, and across our scoliosis product lines. We generated total international revenue of $10.0 million, representing growth of 25% compared to the second quarter of 2022. Growth in the quarter was driven by strong performance within our scoliosis products, as well as our trauma and deformity product lines, including the non-surgical braces. In the second quarter of 2023, trauma and deformity revenue of $27.5 million increased 22% compared to the prior year period. Growth in the quarter was driven primarily by share gains across our entire portfolio with strong contributions from deformity corrections. In the second quarter of 2023, scoliosis revenue of $10.9 million increased 16% compared to the prior year period. Growth was primarily driven by the combined strength of Apifix, Response, and 7D. Finally, sports medicine other revenue in the second quarter of 2023 was $1.2 million, which increased 23% compared to the prior year period. Turning to set deployments. $9.2 million of SETs were consigned in the second quarter of 2023 compared to $3.4 million in the second quarter of 2022. Year-to-date, we have deployed $12.2 million compared to $7.3 million in the first half of last year. The increase was driven by significant new product development deployments, significant Pega deployments, as well as multiple consigned 7D units. Touching briefly on a few key metrics. For the second quarter of 2023 and 2022, gross profit margin remained constant at 75.9%. Total operating expenses increased $6.9 million, or 24%, to $35.6 million in the second quarter of 2023. The increase was primarily driven by the addition of incremental personnel related expenses required to support the ongoing growth of the company, as well as increased sales and marketing expenses driven by the increase in revenue. Sales and marketing expenses increased $0.7 million, or 6%, to $13.2 million in the second quarter of 2023. The increase was primarily driven by increased sales commission expenses. General and administrative expenses increased $5.1 million, or 35%, to $19.7 million in the second quarter of 2023. The increase was driven primarily by an increase in non-cash G&A expenses, including depreciation, amortization, stock-based compensation, as well as some additional personnel-related expenses required to support the ongoing growth of the company. Research and development expenses increased $1.0 million, or 60%, to $2.8 million in the second quarter of 2023, driven by an acceleration of new product introduction efforts. Total other income was $2.3 million for the second quarter of 2023, compared to $3.0 million for the same period last year. We reported adjusted EBITDA income of $2.3 million in the second quarter of 2023, compared to $2.1 million for the second quarter of 2022. We ended the second quarter with $94.8 million in cash, short-term investments, and restricted cash. We continue to maintain strong cash position, as well as $50 million available to us on our line of credit. Turning to guidance. We are reiterating our expectation for full year 2023 revenue to be in the range of $148 to $151 million, representing year-over-year growth of 21 to 23%. Lastly, we continue to expect around $25 million of new sets deployed in 2023, representing a year-over-year annual growth of 24%. Additionally, We continue to expect to generate between $3 to $4 million of adjusted EBITDA in 2023. I'll now turn the call back over to Dave for some closing remarks. Thanks, Fred.
spk07: I'd like to remind you that Orthopediatrics has systematically put into place an impressive array of long-term growth drivers that will continue to produce annual growth of 20% or more for years to come. New product launches, set consignment, surgeon education, and great technologies such as 4thX, Apifix, and 7D are driving surgeon conversion and market share gains. Acquisitions such as MDO and Pega Medical will also continue to grow rapidly. Further, we're building a new non-surgical specialty bracing franchise while also investing in digital health solutions that create new and exciting growth opportunities for the future that are profitable and capital efficient while helping more and more kids on a global basis. In closing, I'd like to thank our surgeon partners and all of my associates for their tireless effort to improve pediatric healthcare around the world. And I'd like to thank you, as shareholders, for supporting our cause. Thank you.
spk18: As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. The first question comes from Ryan Zimmerman with BTIG. Your line is open.
spk08: Hey, guys. Can you hear me OK?
spk05: Yeah, loud and clear. Morning. Morning, Ryan.
spk08: Morning. Morning. Good to speak with you guys. So I just want to ask a couple of questions. if we could get started here. So, you know, just about the environment in the pediatric hospitals, and it sounds like it's improving, but I guess I'm curious kind of, you know, why it still remains challenging in your view, kind of what they're doing to address it, and kind of, you know, what the expectation is for, you know, quote, unquote, normalization in the pediatric space.
spk07: Yeah, good question. So, yeah, it's still not normal, certainly, and we think that's just due to specialized staffing, particularly in the more complex procedures. We're not seeing the same throughput, and that's pretty consistent with what we've seen now for a better part of a year. That said, I think we've kind of moved beyond this in terms of not wanting to dwell on it. I mean, we have to continue to execute the things that we do to drive growth, and I think You know, in the quarter, we saw really nice new customer acquisition that has really, you know, obviously producing 20% growth. We offset a lot of some of the volumes that just weren't normal in some of our major accounts. So I think this is improving, Ryan. I think we're seeing this improve month to month as these children's hospitals are staffing up. You know, obviously, you know, we were just pointing to the reports that were pretty consistent with what we are seeing, that the outpatient environment is very strong. And we do very little of our surgery in the outpatient environment, as you know, and the inpatient environment is a little weaker. And I think when we look at our account by account, particularly places where we have really high share, we see that very clearly. And now it's just a matter of are we onboarding new customers fast enough to offset that? And as this improves, and again, it will, you know, maybe we have a couple more quarters here where this is a gradual improvement. you know, we'll be in a spot where, um, you know, just a better spot. But overall, I think we've tried to point it out, but not dwell on it. And, you know, we got to move forward.
spk08: Yeah. Fair enough. And, and, and appreciate that. Um, maybe just, you, you, you laid out a ton of new products and there's a lot to kind of, uh, chew on, I think for investors, as we think about the back half of the year and then into 24, but a couple of things that stuck out to me, um, Pega deployment and penetration, Pega doubled in revenue, it sounds like, in the U.S. I guess, you know, good results. What do you think you're at in terms of penetration of Pega and kind of where can that grow to? You talked about MDO being kind of this huge opportunity longer term. You know, do you think of Pega in a similar manner? And then, you know, the second question to all this in terms of the portfolio is, is the Scoliosis portfolio complete in your view? with the combination of 7D, AppaFix, and response. Just curious kind of what you're thinking is there as well. Thanks for taking the questions, guys.
spk07: Yeah, good questions, Ryan. So, yeah, the Pega business in the United States nearly doubled since the time of the acquisition, so I want to just clarify that. We're definitely seeing a lot of adoption of Pega products. I think it's clear that the U.S. selling organization is impacting that. far greater impact by the US selling organization than deployed inventory. You know, a lot of that deployed inventory just hit in Q2, so we're not necessarily seeing a ton of the pull through because of deployed inventory. I would say in terms of share, in the United States, the FD product has a really high share. But what we're seeing is because it was limited access to the products, we're seeing the user profile of the products expand. More indications are being treated with the FD rod than I think were before when surgeons struggled to get it. And, you know, with respect to the rest of the products, you know, as we've said, there's six or seven products there. six of them really haven't seen the light of day in the U.S. or international markets. And so, you know, you point to all these new product launches, and you're right. But we're trying to pace all those new product launches with the new things that are going on with Pega, because these products that are coming out of Pega to our customers are new to our sales force and new to our customer as well there. So I guess that's why we have a lot of confidence that now as Pega is you know, we're a year into this and we see the next several years, this opportunity with Pega to continue to grow well in excess of 20% yearly. And then, you know, we point out the international side of the business where we're going through a lot of transition from where they were only stocking distributors internationally. We're transitioning some of those stocking distributors in these 14 agency markets to OP agencies. And you know what that results in. It's a doubling of revenue in those markets that allows us to consign inventory. So, Super bullish on where that can take us. It's not, you know, just a back half of the year thing. I mean, we see this going on for another several years. Probably not at the macro level as big of opportunity as we see for the non-surgical specialty bracing business. I mean, we, you know, we acquired MDO with the intent to make it kind of the launch of a new platform of growth for us in what we would consider a near adjacency in pediatric orthopedics in non-surgical specialty bracing. And as we've done that, it is very clear that there are growth opportunities all over that market and opportunities with very limited competition, good reimbursement, and it doesn't take capital, as much capital deployed there. So again, not purely a second half thing, but I think as we get into 2024, 2025, we see the opportunity for this non-specialty bracing business to really, really accelerate for the next several years. Lastly, on the SCOLE side, I don't think the product portfolio is fully complete. You know, we have three different projects right now in R&D that we're working on on EOS, so early onset SCOLEosis. And that's an area of the market which we estimate is about 15% of the SCOLEosis market that really is untouched by our product portfolio. And those areas are very complex. It's very complex surgery with the top KOLs and the top institutions. And as we launch products in that space, probably first product we'll see is our rib and pelvic system. And then the guided growth system that I mentioned, we expect those products to obviously drive new, penetrate that 15% of the market But much like we're seeing with Apifix and 7D, we expect that to pull us through and pull us into a lot of major institutions that are just dabbling with our products now.
spk09: Got it. Thanks for taking the questions, Dave. Very helpful. You bet.
spk18: Please stand by for our next question. Our next question comes from Matthew O'Brien with Piper Sandler. Your line is open.
spk08: Morning. Thanks for taking my question. So, Dave or Fred, can you just drill down a little bit more on the domestic business in the quarter? It was a little bit softer than Q1. I know you still got some headwinds. How meaningful are those headwinds? Can you quantify it at all? I know you said deformity was a little bit softer than you expected. Or maybe just talk about how things built throughout the quarter and then Can you delineate the share gains that you're seeing, you know, underlying some of these headwinds that you're facing? Are, you know, if things come back to kind of pre-pandemic levels, which I can't imagine they won't, or pre-RSV levels, you know, how big a tailwind could that be given the share gains that you're taking?
spk07: Yeah, yeah, good question. Thanks, Matt. Yeah, so we've been doing this a long time, and I think, you know, an indication that a marketplace is not Completely behaving entirely rational is probably what we saw in Q2. You know, when we think about the build, we really, really struggled. And we pointed it out in the call. We struggled in April. And, you know, we just didn't grow the way that we would expect it for, you know, the month. And then we saw this major rebound in May. I mean, a very strong snapback. So, obviously, Matt, the people that were, you know, our customers didn't leave us in April and stop liking our products. They came back in May, and then we saw kind of an ease into June in terms of the seasonality, and that's carried forward through the summer, so having a fairly normal summer. And so, you know, when we look at the months, it's choppy and choppier than what we had seen certainly previous to the pandemic. And so I guess that's why it gives us a bit of pause to, you know, we like what we're seeing, we like the share gain, but even despite a lot of that share gain, we're we have a month and a quarter that just doesn't look normal or rational. And I think that gives Fred and me both a bit of pause to not get out ahead of ourselves, not to be guiding super aggressively because that's just not normal. Now, I think over the course of the next few quarters, certainly into 2024, things will start to normalize. We were very pleased to see June and we're pleased to see the seasonality in the business. I think there was some question coming into this quarter about particularly against a very difficult comp we had from prior year. We had some concern that could June be as big as it needs to be given the staffing issues. And it wasn't as big as it's ever been in terms of throughput, but it certainly was big and it's given way to a really nice summer here for us. So we haven't counted it all up in terms of what we think is going to happen when all of this comes back to normal, but You've got to think that with more and more customers using more and more products and improving market, we like the trend. Again, not sure that it's going to all explode in Q3, Q4, but certainly the trend is to 20% growth like we've delivered for years.
spk08: Got it. Appreciate that. And then as far as the bracing business, you mentioned $100 million business eventually. It sounds like more like 25. That's really going to start to ramp up significantly. But can you just talk about the investment needed, how you build that business to $100 million, and how you do that alongside the rest of the company that's growing nicely as well? Thanks.
spk07: Yeah, so good question. We see a lot of opportunity on the R&D side. We knew that before we acquired MDO, but I think once our customers saw us make that acquisition and we started seeing the growth that MDO is producing just through the partnership of our people and their people and now us together, it gave us a lot of confidence that we made the right decision. Move Bar came out. We're seeing growth related to that. We got DF2 on the way. DF2 was featured prominently in some KOL papers that were awarded at POSNA for the last two years. And there's just a lot of buzz around those product lines. And there's very limited competition. And so we think through, you know, the combination of pretty heavy investment on the R&D side, and when I say heavy investment, these are not particularly costly to develop because of the regulatory requirements are less than our implants. And then, you know, some investment in the selling organization. We feel very strongly that we're going to be able to build that business and build it pretty rapidly. I think it's going to contribute in 2024. It's probably one of the factors that will contribute to, you know, continuation of kind of our 20% plus growth base. But yeah, you're probably right. It gets much bigger in 2025, 2026. And Fred and I just want to point out that this is another area of growth we haven't talked a lot about, but it should give investors a lot of confidence that we've got another We've got another lever of growth here in addition to all the things that we're doing on our surgical side that are going to continue to produce really nice revenue growth, profit, doesn't require consigned inventory, conserves cash. I would think that's everything we all have been aspiring towards.
spk14: Got it. Thank you.
spk18: Please stand by for our next question. The next question comes from David Saxon with Needham and Company. Your line is open.
spk11: Yeah, good morning, guys, and thanks for taking my questions. I guess first I wanted to ask on Apifix. I know there's a competitive product launching. So, you know, are you seeing any impact around Apifix docs trawling that new product? I know you called out new and existing user growth, but just would love to hear kind of what you're seeing from a competitive perspective and also just any update on Appifix and kind of just the expectations for the year.
spk07: Yeah, so we haven't actually heard. I'm sure it's a fine product. We just haven't heard anybody use the product in the U.S. yet. I'm sure it's happening. But, you know, we are aware of the product internationally. I think it's been available for a number of years, but listen, I think our position on non-fusion surgery in general is that as other people enter the tethering space, it just drives awareness, patient awareness and surgeon awareness that non-fusion surgery for pediatric scoliosis is here to stay. It's going to grow over time. We view the market as fairly embryonic, so right, we're going to see new people enter. No one can compete directly with what we do, obviously on the posterior side, and much easier surgery. And now when you stack up results, albeit early, one-year results, but we stack those kinds of results up with the ease of use of this product, I think that's what's driving surgeons to start adopting the technology. We added a number of new users. We have a number of sites that are applying for their first IRB to start using this product commercially. And I think this is a continuation. We think we'll see this product continue to grow as the marketplace grows. And the more people that enter the market, particularly on the anterior side of the surgical field, probably benefits us because it just raises awareness. And again, I think we stand by our claim here. We think this business has, you know, give or take doubles this year and probably does that again next year. And just really like this and like the results we're seeing.
spk11: Okay, got it. That's helpful. And then just on OpEx, it was, I think, mid-20s percent in the first half versus last year. It looks like a lot of that's, you know, R&D behind some new product launches and G&A. So, like, does that continue or can we see some more leverage in the model as we go into the back half?
spk10: Yeah, we'll see some more leverage in the back half of the year. It's really volume dependent, right? As the volume increases significantly second quarter to first quarter, we get some nice leverage. Dave mentioned earlier the lack of consignment on the non-bracing side. Those products are all sold basically through our e-commerce website, so we're not paying a commission on those bracing products, which gives us nice leverage on the sales and marketing side. R&D, we will continue to invest in that pretty heavily. And then on the G&A side, it's really the stock comp depreciation and amortization that's driving that. We're getting leverage on the cash side of G&A. So, yeah, we should see some leverage continue in the second half of the year and really into next year as we have different growth drivers, I guess, improving the top line.
spk11: Okay, got it. And then just a quick modeling question. What was the inorganic contribution in the quarter?
spk10: So, the only impact is Pega. So, Pega was purchased July 1st of last year, and that was about a $6 million run rate business, so a million and a half-ish pre-acquisition. Okay, got it. Thanks.
spk18: Please stand by for the next question. The next question comes from Dave Turkley with JMP. Your line is open.
spk22: Great. Good morning.
spk13: Can you hear me?
spk23: Yeah. Just to clarify one up front here, the month-to-month comment, I'm assuming that's typical in 2Q, but it may not be. I understand that it sounds like it started slow and got a lot better, but is that typical for you in 2Q, or is that not typical in terms of how it progresses?
spk07: Yeah, yeah, Dave, let me clarify. It is typical to see that ramp. I guess what we saw is growth rates, the comparables were not normal, at least as it pertains to April. Normally, we see this nice, smooth ramp into June, and then obviously, you know, June, July, August, those are our big months in terms of volume. But, you know, as we just look at what April did versus what April did prior year, and frankly, what April does prior years or in the past, you know, we're still seeing that chop. That was what I was trying to point out is not that there wasn't a steady ramp into the year that was normal. It was just that what we saw in the month was pretty inconsistent with what we historically see in terms of kind of the growth rates that we would see over prior year. And then we saw almost complete reversal of that in May where, you know, revenue shot up and carried us into the summer. Does that make sense?
spk23: Yeah, totally. I get it. Thank you for that. And as a quick follow-up, you mentioned enabling technologies, you know, Firefly and 7D driving, even some response. I guess I'd just like to get your thoughts on how, you know, your docs are adopting enabling technologies. What you expected is, are they more willing? Is it, you know, are they conservative? And it's taken a little longer. Just any color you could give us in terms of, you know, how that initiative is rolling out. Thank you.
spk07: Yeah. There's no question that the pediatric orthopedic surgeons, particularly on the scully side, are keenly interested in enabling technologies, and particularly on the spine side. You know, we see a real opportunity for that also on the trauma limb deformity side, which is why we, you know, really like this partnership. We think over time, you know, the partnership with C-Spine 7D OrthoFix will allow us to, you know, to potentially get into the trauma and limb deformity side. So there's a big demand for that, certainly. I think the demand for navigation with very low radiation for pediatric patients is extremely high. I think one of the things that's held navigation back in the pediatric space is because historical navigation platforms involve so much radiation. And, you know, the pediatric patient absorbs a lot of that radiation and it's not particularly good. And so now that there's a solution that is very low radiation and, frankly, allows people in the operating room not even to have to wear lead, And, you know, a long surgery, that's a big deal. I think the surgeon feedback, healthcare provider feedback across the board related to the enabling technologies, particularly 7D, is very high. The only thing that I think we were a bit surprised by is, you know, we have never been in the capital market, capital equipment sales market. And so this is a bit new for us. And frankly, we were probably a bit naive in terms of how we thought that the hospital environment would allow for purchase or even consignment on contract some of these units. And so we've done a lot of work over the last year or so to put a lot of options in play. And we're starting to see, particularly Q2, and we think throughout the balance of the next year to 18 months, a number of these units that we have in sites start to go on contract from a consignment standpoint. And we even have some sales. And we have some sales pending, may not happen in Q3, but we're going to have some capital sales here, we believe, in Q4. And so, again, like what we see there, it's probably just maybe a little delayed in terms of not the surgeon adoption, but the hospital taking on the product and getting it going. Does that make sense?
spk24: Yes, and thank you for that. Sure.
spk18: Please stand by for the next question. The next question comes from Sam Brodowski with Truist Securities. Your line is open.
spk21: Hey, thanks for taking the question, and congrats on a good quarter. Just the first one, just to put a finer point on it, were May and June sort of back to the normal inpatient census level that you're expecting, or still a little bit of room to go there? And then just relating that to guidance. The second, I still assume that environment's going to be choppy in terms of patient volumes, right?
spk07: Yeah, so May and June, the inpatient environment still wasn't normal. You know, I think when we look at accounts where we would say, Sam, we have nearly 100% share, particularly on elective limb deformity and elective scoliosis, it's pretty easy to measure that. We just look at the volume, total procedures done, revenue generated, and We see in a lot of those big accounts, and we cite these three places that were AppaFix accounts, but they're also ScoliFusion accounts. I mean, those accounts were, we had some accounts that were way off comparatively to prior year. And again, it's not, we didn't lose share in those accounts. And so, you know, it isn't normal, but it's better, right? It was better in May and June, and April was kind of an enigma for us. It was an odd month all the way around. So, no, we're not signaling that, you know, just that it certainly got better. It still wasn't running kind of full tilt like we would expect it to, you know, in the coming quarters.
spk21: Got it. Thanks. That's helpful. And then just one on the international scoliosis. Can you help us think about, you know, how big of an impact that could be? How much scale do you think you can have in 24 in international markets with scoliosis? And should we think about sort of the whole portfolio scenario? Being launching nationally, including at the fixers and more just starting with. Some of the core products and then going from there.
spk07: Yeah, so probably most people don't know probably I guess I realized that we essentially sell no scoliosis products in Europe right now. And we do sell scoliosis, obviously, in Australia and South America, Latin America, and have a good business there. But, you know, the products, we had never really launched Scoli. Part of this is related to EMDR, right, and which products and what timing we were going to get EMDR approval. And so that's why we call that out. It's a good pickup, Sam, that we call this out that there's a number of products in Europe that are a number of products in the united states that are very well uh accepted here in the us that are not sold in europe because of pending approval related to eumdr and so we don't know the exact timing of when in 2024 the full portfolio would be approved but it is a growth driver for us certainly as soon as that happens as well as even into 2025 and 2026 where we have a lot of new products that will ultimately introduced into our largest markets outside of the united states Scoliosis just being one. And so I don't know if the impact on the Scoliosis or the overall business next year will be huge for Scoli in Europe. It's certainly going to take some time to build, but it definitely will impact the Scoliosis growth rate next year, even if that number's, you know, say a few million dollars. Now, with respect to Apifix outside of the U.S., we have actually pulled in accounts post-acquisition. The Apifix leadership previous had allowed some people to do some procedures outside of the United States through stocking distributors that we have, in fact, halted because we're trying to capture data and want to make sure that that data is good. So we're a bit in the process of relaunching Apifix through our Scoliosis strategy. And again, we expect to see a very similar dynamic, right? Apifix brings customers to our product portfolio. We follow that up with response and the full portfolio and kind of pull that through. We expect those dynamics to be similar in major European markets. And again, not huge in 2024, but it will have an impact on the growth rate.
spk01: Great. Thank you.
spk07: Any questions?
spk18: I show no further questions at this time. This concludes today's conference call. Thank you for participating. You may now disconnect. Music. Thank you. Thank you. Good morning and welcome to Orthopediatrics Corporation's second quarter 2023 earnings conference call. At this time, all participants are in listen-only mode. We will be facilitating a question and answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Tripp Taylor, from the Gilmartin Group for a few introductory comments. Please go ahead.
spk20: Thank you for joining today's call. With me from the company are David Bailey, President and Chief Executive Officer, and Fred Hite, Chief Operating and Financial Officer. Before we begin today, let me remind you that the company's remarks include forward-looking statements within the meaning of federal securities laws. including the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to numerous risks and uncertainties, and the company's actual results may differ materially. For discussion of risk factors, I encourage you to review the company's most recent quarterly report on Form 10-Q, which will be filed with the SEC today. During the call today, management will also discuss certain non-GAAP financial measures, which are supplemental measures of performance. The company believes these measures provide useful information for investors evaluating its operations period over period. For each non-GAAP financial measure referenced on this call, the company has included a reconciliation of the non-GAAP financial measure to the most directly comparable GAAP financial measure in its earnings release. Please note that the non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as substitutes for other orthopediatrics financial results prepared in accordance with GAP. In addition, the content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast today, August 1st, 2023. Except as required by law, the company undertakes no obligation to revise or update any statements to reflect events or circumstances taking place after the date of this call. With that, I'd like to turn the call over to David Bailey. President and Chief Executive Officer.
spk13: Thanks, Chris.
spk07: Good morning, everyone, and thank you for joining us on our second quarter 2023 conference call. As we start all earnings calls, I'd like to begin by highlighting that we helped a record 21,000 children in the second quarter of 2023, and since inception, we have now helped over 670,000 kids. Helping more children remains the best measure of our success. In the second quarter of 2023, we generated record high revenue of $39.6 million, representing growth of 20% compared to the second quarter of 2022. Despite a challenging operating environment within Children's Hospital, we continued growing our business by taking market share and are encouraged by the momentum we've generated in the first half of the year. We are proud to have again generated growth of 20% against the strongest comparable period of the year while deploying $9.2 million worth of sets. Altogether, we are positioned favorably for the second half of the year. As expected, we are experiencing gradual month-by-month improvements in the inpatient surgical environment where nearly all of our procedures are performed. As you may have read, many insurance companies have reported increased overall volumes but lower inpatient procedures. Our observations are consistent with this recent commentary, and we continue to feel the impacts of lower than historical average volumes in the children's hospital environment. Nevertheless, execution of our historically successful strategy is leading to consistent quarter-over-quarter share gain and is producing sustainable growth regardless of market conditions. Therefore, we are reiterating our revenue guidance of $148 to $151 million, representing growth of 21 to 23%. Moving to our revenue segment. In the second quarter of 2023, we generated total trauma and deformity revenue of $27.5 million, representing growth of 22% compared to the prior year period. Revenue growth in the quarter was led by strong performances in deformity correction and PEGA products. The quarter saw a record X6 performance from our external fixation portfolio driven by Orthex, the recently launched pre-planning software, and the new drive rail system. Defos plating system, and PD plates, a system we first launched in 2008, all were particularly strong in the quarter. Although the trauma franchise grew slightly slower than it has in the last few quarters, P&P femur and cannulated screws continued their dynamic growth trend. Additionally, PEGA product sales have been better than we ever expected, nearly doubling in the U.S., and we are just now seeing the early returns of additional deployed inventory. International Pega revenue, while strong, has yet to reach its full potential as we are working through several conversions of stocking distributors to our agencies. We expect this to become a strong tailwind and a solid source of growth in the second half of 2023 and beyond. Overall, strong Pega revenue will continue to benefit the company for the next several years, and we are very pleased with how this is trending. Speaking of Pega, in June, we announced the limited launch and first procedure using the gyro system developed by the PEGA R&D team in Montreal. This unique tethering system utilizes guided growth, providing surgeons a new way to treat limb deformities without the need for osteotomy. This system builds on our legacy of innovation and illustrates another reason why we are so pleased with the PEGA acquisition, as it strengthens the orthopediatrics R&D pipeline. Lastly, on the trauma deformity R&D side, we are eagerly anticipating the FDA approval and beta launch of our PMP tibia system, which will be a first-of-its-kind pediatric rigid tibial nailing system modeled after our market-leading and largest trauma product, the PMP femur. PMP tibia will serve as a follow-on to our largest and fastest-growing trauma product, PMP femur, and we are extremely excited about its growth potential. If we see a successful approval, we are targeting the first case late in the third quarter. Within the T&D business, our non-surgical specialty bracing business continues to perform well, highlighted by MDO clubfoot bracing. In the second quarter, the non-surgical specialty bracing business launched the clubfoot move bar, expanding the MDO portfolio, which has received a very positive customer response. We are eagerly awaiting the launch of several additional products from our team in Iowa as well as the much-anticipated DF2 femur fracture brace, which recently proceeded through final validation and is launching this month. With respect to MDO, the addition of new products in existing markets and expansion into new markets is bolstering growth. Now slightly more than a year into launch, we have validated our thesis that orthopediatrics can and will build a large and profitable business in the specialty bracing space. Our customers are presenting us with several unmet needs in the areas that can truly impact care for kids. And we're planning to further invest in R&D that can help deliver much needed solutions. Our specialty grazing business represents the most capital efficient opportunity for growth in our portfolio and reduces the need for continual capital deployment. While we are very early, we see this business growing to in excess of $100 million in the next several years, providing a new and exciting growth opportunity. Moving to the scoliosis business. In the second quarter of 2023, we generated revenue of $10.9 million, representing growth of 16% compared to the prior year period, driven by a continuation of our strategy of promoting the combined strength of apophix, response, and 7D placement. The second quarter started uncharacteristically slow, but dramatically improved into May. And the usual summer seasonality started to show up in June, which we expect to carry forward throughout the summer. We also expect the multiple 7D units placed in GUE2, along with our strong consignment and sales pipeline, to bolster scoliosis growth in the second half of the year. We're pleased to see the value proposition of the combination of Apifix, 7D, and response, comprehensively addressing surge in needs and driving market share gain, again, Total users in Q2 increased meaningfully compared to the prior year period. Enabling technologies such as additional 7D placement and ongoing Firefly usage is driving share gain for our response fusion platform, and Apifix non-fusion is helping expose new surgeons to all our scoliosis technology, leading to new customer acquisition. Apifix usage is growing, both in terms of new users and increases among existing users. Our scoliosis growth continues despite an absence of revenue from three of our largest sites as both surgeons have transitioned to new practice locations. We expect this will normalize in the coming quarters. We continue to make progress on the development of Apifix's non-fusion clinical data, which we believe will lead to increasing KOL support and podium presence. For example, one-year data of 148 patients was presented from the podium at Poznan by Dr. Jeff Haft. that showed just five of 148 apopex patients went on to fusion and a low device-related re-operation rate of just 6.7%. We're pleased to see these results, especially given that these are the first cases done in the US. As we learn more, work through the learning curve, and make further advancements on the implant and technique, we expect results will get even better in the coming years. Given the early data, we expect to see several additional publications in the quarters to come. On the R&D front, in Q2, we launched several key products and line extensions, including response power, response power torque, response cannulated screws, and response derotation instrumentation. During the quarter, we performed several surgeries with each of these new products and received positive surgeon feedback, with especially glowing commentary about our power system. Lastly, we continued progress on our EOS suite of products and achieve major milestones on our EOS Guided Growth System during Q2. We expect FDA submission of this key product by year end. Moving on to international. In the second quarter of 2023, we generated international revenue of $10 million compared to $8 million the prior year period, delivering 25% growth, primarily driven by strong performance with our legacy products, slightly offset by slower MDO growth due to timing of stocking purchases by new MDO distributors that were very high in Q2 of 2022. Agency market sales in Europe were particularly strong, signalizing a normalizing surgical environment, and progress in our German direct sales model is a bit ahead of schedule. We are pleased with this rebound and expect the strength to continue in the second half of this year. While small at this time, we are at the very beginning of launching our scoliosis business in Europe. and expect this to positively impact revenue as early as 2024. Additionally, sales of Pega products are just starting to contribute to revenue growth outside of the U.S. as we begin to transition stocking distributors to our agencies in 14 markets. Once complete, we expect to see very similar results to that of the U.S. and believe this will be a major tailwind to international growth in the second half of 2023 and beyond. Additionally, we've worked toward expanding our international distribution footprint, and I have a few updates to share. This quarter, we signed two new stocking distributor agreements. The first is for distribution of our scoliosis product in Brazil, and the second is an agreement to distribute the broader orthopediatrics portfolio in Peru. These distribution agreements will strengthen our international presence, and we expect them to contribute to our growth in the second half of the year and beyond. Lastly, we've received positive audit feedback related to the long process of EU MDR compliance with orthopediatrics products and expect to achieve EU MDR approval in the coming year, thus opening opportunities to launch several new to Europe products in 2024. It is our intention to have the full suite of products compliant in 2024. That brings us to surgeon training and education. To support our goal of helping advance the entire field of pediatric orthopedics, we continue to prioritize outsized support of pediatric orthopedic clinical education and training. This pillar of our strategy is central to who we are as a company, and we believe signals to our customers that we're different than our competitors. Throughout the second quarter, Orthopediatrics held over 90 events, which included training sessions and educational programs reaching over 1,200 healthcare professionals. In May, we unveiled our new Emerald sponsorship at POSNA in Nashville, solidifying our position as the leading supporter of the Surgical Society. The 2023 meeting saw record attendance, and the Society continues to grow in both membership and prominence in pediatric healthcare. Through our long-term commitment to PASMA, we are providing ongoing support of rigorous training events for surgeons and other healthcare professionals, awarding educational grants and scholarships, and have founded a Women's Affinity Group to support our combined efforts in diversity, equity, inclusion, and belonging across the subspecialty. Additionally, we hosted interactive case-based seminars to discuss novel treatment options in adolescent idiopathic scoliosis, utilizing our Apifex technology. And we celebrated our colleague and friend, retired Chief Medical Officer, Dr. Peter Armstrong, as he was inducted into the Poznan Hall of Fame. Lastly, before I turn it over to Fred, I'm delighted to welcome Dr. George Dyer to our Board of Directors. He is a renowned orthopedic surgeon at Brigham and Woman's Hospital in Boston, as well as being associate professor of orthopedic surgery at Harvard Medical School. For 10 years, George was the program director of the Harvard Combined Orthopedic Residency Program, one of the largest orthopedic residency programs in the country. His deep experience will allow him to contribute to our clinical training program, as well as our product portfolio strategy. With that, I'll turn the call over to Fred to provide more detail on our financial results.
spk10: Fred? Thanks, Dave. Our second quarter 2023 worldwide revenue of $39.6 million increased 20% compared to the second quarter of 2022. Growth in the quarter was driven primarily by continued share gains across our legacy portfolio, as well as growth of our non-surgical specialty bracing business. U.S. revenue was $29.6 million, a 19% increase from the second quarter of 2022. Growth in the quarter was delivered across our trauma and deformity product lines, including our non-surgical specialty bracing business, and across our scoliosis product lines. We generated total international revenue of $10.0 million, representing growth of 25% compared to the second quarter of 2022. Growth in the quarter was driven by strong performance within our scoliosis products, as well as our trauma and deformity product lines, including the non-surgical braces. In the second quarter of 2023, trauma and deformity revenue of $27.5 million increased 22% compared to the prior year period. Growth in the quarter was driven primarily by share gains across our entire portfolio with strong contributions from deformity corrections. In the second quarter of 2023, scoliosis revenue of $10.9 million increased 16% compared to the prior year period. Growth was primarily driven by the combined strength of Apifix, Response, and 7D. Finally, sports medicine other revenue in the second quarter of 2023 was $1.2 million, which increased 23% compared to the prior year period. Turning to set deployments. $9.2 million of SETs were consigned in the second quarter of 2023 compared to $3.4 million in the second quarter of 2022. Year-to-date, we have deployed $12.2 million compared to $7.3 million in the first half of last year. The increase was driven by significant new product development deployments, significant Pega deployments, as well as multiple consigned 7D units. Touching briefly on a few key metrics. For the second quarter of 2023 and 2022, gross profit margin remained constant at 75.9%. Total operating expenses increased $6.9 million, or 24%, to $35.6 million in the second quarter of 2023. The increase was primarily driven by the addition of incremental personnel related expenses required to support the ongoing growth of the company, as well as increased sales and marketing expenses driven by the increase in revenue. Sales and marketing expenses increased $0.7 million, or 6%, to $13.2 million in the second quarter of 2023. The increase was primarily driven by increased sales commission expenses. General and administrative expenses increased $5.1 million, or 35%, to $19.7 million in the second quarter of 2023. The increase was driven primarily by an increase in non-cash G&A expenses, including depreciation, amortization, stock-based compensation, as well as some additional personnel-related expenses required to support the ongoing growth of the company. Research and development expenses increased $1.0 million, or 60%, to $2.8 million in the second quarter of 2023, driven by an acceleration of new product introduction efforts. Total other income was $2.3 million for the second quarter of 2023, compared to $3.0 million for the same period last year. We reported adjusted EBITDA income of $2.3 million in the second quarter of 2023, compared to $2.1 million for the second quarter of 2022. We ended the second quarter with $94.8 million in cash, short-term investments, and restricted cash. We continue to maintain strong cash position, as well as $50 million available to us on our line of credit. Turning to guidance. We are reiterating our expectation for full year 2023 revenue to be in the range of $148 to $151 million, representing year-over-year growth of 21 to 23%. Lastly, we continue to expect around $25 million of new sets deployed in 2023, representing a year-over-year annual growth of 24%. Additionally, We continue to expect to generate between $3 to $4 million of adjusted EBITDA in 2023. I'll now turn the call back over to Dave for some closing remarks. Thanks, Fred.
spk07: I'd like to remind you that Orthopediatrics has systematically put into place an impressive array of long-term growth drivers that will continue to produce annual growth of 20% or more for years to come. New product launches, set consignments, surgeon education, and great technologies such as 4thX, Apifix, and 7D are driving surgeon conversion and market share gains. Acquisitions such as MDO and PegaMedical will also continue to grow rapidly. Further, we're building a new non-surgical specialty bracing franchise while also investing in digital health solutions that create new and exciting growth opportunities for the future that are profitable and capital efficient while helping more and more kids on a global basis. In closing, I'd like to thank our surgeon partners and all of my associates for their tireless effort to improve pediatric healthcare around the world. And I'd like to thank you, as shareholders, for supporting our cause. Thank you.
spk18: As a reminder, to ask a question, please press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. Please stand by while we compile the Q&A roster. The first question comes from Ryan Zimmerman with BTIG. Your line is open.
spk08: Hey, guys. Can you hear me okay?
spk05: Yeah, loud and clear. Morning. Morning, Ryan.
spk08: Morning. Morning. Good to speak with you guys. So I just want to ask a couple questions. if we could get started here. So, you know, just about the environment in the pediatric hospitals, and it sounds like it's improving, but I guess I'm curious kind of, you know, why it still remains challenging in your view, kind of what they're doing to address it, and kind of, you know, what the expectation is for, you know, quote, unquote, normalization in the pediatric space.
spk07: Yeah, good question. So, yeah, it's still not normal, certainly, and we think that's just due to specialized staffing, particularly in the more complex procedures. We're not seeing the same throughput, and that's pretty consistent with what we've seen now for a better part of a year. That said, I think we've kind of moved beyond this in terms of not wanting to dwell on it. I mean, we have to continue to execute the things that we do to drive growth, and I think You know, in the quarter, we saw really nice new customer acquisition that has really, you know, obviously producing 20% growth. We offset a lot of some of the volumes that just weren't normal in some of our major accounts. So I think this is improving, Ryan. I think we're seeing this improve month to month as these children's hospitals are staffing up. You know, obviously, you know, we were just pointing to the reports that were pretty consistent with what we are seeing, that the outpatient environment is very strong. And we do very little of our surgery in the outpatient environment, as you know, and the inpatient environment is a little weaker. And I think when we look at our account by account, particularly places where we have really high share, we see that very clearly. And now it's just a matter of are we onboarding new customers fast enough to offset that? And as this improves, and again, it will, you know, maybe we have a couple more quarters here where this is a gradual improvement. you know, we'll be in a spot where, um, you know, just a better spot. But overall, I think we've tried to point it out, but not dwell on it. And, you know, we got to move forward.
spk08: Yeah. Fair enough. And, and, and appreciate that. Um, maybe just, you, you, you laid out a ton of new products and there's a lot to kind of, uh, chew on, I think for investors, as we think about the back half of the year and then into 24, but a couple of things that stuck out to me, um, Pega deployment and penetration, Pega doubled in revenue, it sounds like, in the U.S. I guess, you know, good results. What do you think you're at in terms of penetration of Pega and kind of where can that grow to? You talked about MDO being kind of this huge opportunity longer term. You know, do you think of Pega in a similar manner? And then, you know, the second question to all this in terms of the portfolio is, is the Scoliosis portfolio complete in your view? with the combination of 7D APA fix and response. Just curious kind of, you know, what you're thinking is there as well. Thanks for taking the questions, guys.
spk07: Yeah, good questions, Ryan. So, yeah, the Pega business in the United States nearly doubled since the time of the acquisition. So I want to just clarify that. We're definitely seeing a lot of adoption of Pega products. I think it's clear that the U.S. selling organization is impacting that. far greater impact by the US selling organization than deployed inventory. You know, a lot of that deployed inventory just hit in Q2. So we're not necessarily seeing a ton of the pull through because of deployed inventory. I would say in terms of share, in the United States, the FD product has a really high share. But what we're seeing is because it was limited access to the products, we're seeing the user profile of the products expand. More indications are being treated with the FD rod than I think were before when surgeons struggled to get it. And, you know, with respect to the rest of the products, you know, as we've said, there's six or seven products there. six of them really haven't seen the light of day in the U.S. or international markets. And so, you know, you point to all these new product launches, and you're right. But we're trying to pace all those new product launches with the new things that are going on with Pega, because these products that are coming out of Pega to our customers are new to our sales force and new to our customer as well there. So I guess that's why we have a lot of confidence that now as Pega is We're a year into this and we see the next several years, this opportunity with Pega to continue to grow well in excess of 20% yearly. And then we point out the international side of the business where we're going through a lot of transition from where they were only stocking distributors internationally. We're transitioning some of those stocking distributors in these 14 agency markets to OP agencies. And you know what that results in. It's a doubling of revenue in those markets that allows us to consign inventory. Super bullish on where that can take us. It's not, you know, just a back half of the year thing. I mean, we see this going on for another several years. Probably not at the macro level as big of opportunity as we see for the non-surgical specialty bracing business. I mean, we, you know, we acquired MDO with the intent to make it kind of the launch of a new platform of growth for us in what we would consider a near adjacency in pediatric orthopedics in non-surgical specialty bracing. And as we've done that, it is very clear that there are growth opportunities all over that market and opportunities with very limited competition, good reimbursement, and it doesn't take capital, as much capital deployed there. So again, not purely a second half thing, but I think as we get into 2024, 2025, we see the opportunity for this non-specialty bracing business to really, really accelerate for the next several years. Lastly, on the SCOLE side, I don't think the product portfolio is fully complete. You know, we have three different projects right now in R&D that we're working on on EOS, so early onset SCOLEosis. And that's an area of the market which we estimate is about 15% of the SCOLEosis market that really is untouched by our product portfolio. And those areas are very complex. It's very complex surgery with the top KOLs and the top institutions. And as we launch products in that space, probably first product we'll see is our rib and pelvic system. And then the guided growth system that I mentioned, we expect those products to obviously drive new, penetrate that 15% of the market But much like we're seeing with Apifix and 7D, we expect that to pull us through and pull us into a lot of major institutions that are just dabbling with our products now.
spk09: Got it. Thanks for taking the questions, Dave. Very helpful. You bet.
spk18: Please stand by for our next question. Our next question comes from Matthew O'Brien with Piper Sandler. Your line is open.
spk08: Morning. Thanks for taking my question. So, Dave or Fred, can you just drill down a little bit more on the domestic business in the quarter? It was a little bit softer than Q1. I know you still got some headwinds. How meaningful are those headwinds? Can you quantify it at all? I know you said deformity was a little bit softer than you expected. Or maybe just talk about how things built throughout the quarter and then Can you delineate the share gains that you're seeing, you know, underlying some of these headwinds that you're facing? Are, you know, if things come back to kind of pre-pandemic levels, which I can't imagine they won't, or pre-RSV levels, you know, how big a tailwind could that be given the share gains that you're taking?
spk07: Yeah, yeah, good question. Thanks, Matt. Yeah, so we've been doing this a long time, and I think, you know, an indication that a marketplace is not Completely behaving entirely rational is probably what we saw in Q2. You know, when we think about the build, we really, really struggled. And we pointed it out in the call. We struggled in April. And, you know, we just didn't grow the way that we would expect for, you know, the month. And then we saw this major rebound in May. I mean, a very strong snapback. So obviously, Matt, the people that were, you know, our customers didn't leave us in April and stop liking our products. They came back in May, and then we saw kind of an ease into June in terms of the seasonality, and that's carried forward through the summer, so having a fairly normal summer. And so, you know, when we look at the months, it's choppy and choppier than what we had seen certainly previous to the pandemic. And so I guess that's why it gives us a bit of pause to, you know, we like what we're seeing. We like the share gain. But even despite a lot of that share gain, we have a month and a quarter that just doesn't look normal or rational. And I think that gives Fred and me both a bit of pause to not get out ahead of ourselves, not to be guiding super aggressively because that's just not normal. Now, I think over the course of the next few quarters, certainly into 2024, things will start to normalize. We were very pleased to see June and we're pleased to see the seasonality in the business. I think there was some question coming into this quarter. particularly against a very difficult comp we had from prior year. We had some concern that could June be as big as it needs to be, given the staffing issues. And it wasn't as big as it's ever been in terms of throughput, but it certainly was big, and it's given way to a really nice summer here for us. So we haven't counted it all up in terms of what we think is going to happen when all of this comes back to normal, but You've got to think that with more and more customers using more and more products and improving market, we like the trend. Again, not sure that it's going to all explode in Q3, Q4, but certainly the trend is to 20% growth like we've delivered for years.
spk08: Got it. Appreciate that. And then as far as the bracing business, you mentioned $100 million business eventually. It sounds like more like 25. That's really going to start to ramp up significantly. But can you just talk about the investment needed, how you build that business to $100 million, and how you do that alongside the rest of the company that's growing nicely as well? Thanks.
spk07: Yeah, so good question. We see a lot of opportunity on the R&D side. We knew that before we acquired MDO, but I think once our customers saw us make that acquisition and we started seeing the growth that MDO was producing just through the partnership of our people and their people and now us together, it gave us a lot of confidence that we made the right decision. Move Bar came out. We're seeing growth related to that. We got DF2 on the way. DF2 was featured prominently in some KOL papers that were awarded at POSNA for the last two years. And there's just a lot of buzz around those product lines, and there's very limited competition. And so we think through, you know, the combination of pretty heavy investment on the R&D side, and when I say heavy investment, these are not particularly costly to develop because of the regulatory requirements are less than our implants. And then, you know, some investment in the selling organization. We feel very strongly that we're going to be able to build that business and build it pretty rapidly. I think it's going to contribute in 2024. It's probably one of the factors that will contribute to, you know, you know, continuation of kind of our 20% plus growth base. But yeah, you're probably right. It gets much bigger in 2025, 2026. And I just, you know, Fred and I just want to point out that this is another area of growth. We haven't talked a lot about, but it should give investors a lot of confidence that, you know, we've got another We've got another lever of growth here in addition to all the things that we're doing on our surgical side that are going to continue to produce really nice revenue growth, profit, doesn't require consigned inventory, conserves cash. I would think that's everything we all have been aspiring towards.
spk14: Got it. Thank you.
spk18: Please stand by for our next question. The next question comes from David Saxon with Needham and Company. Your line is open.
spk11: Yeah, good morning, guys, and thanks for taking my questions. I guess first I wanted to ask on Apifix. I know there's a competitive product launching. So, you know, are you seeing any impact around Apifix docs trawling that new product? I know you called out new and existing user growth, but just would love to hear kind of what you're seeing from a competitive perspective and also just any update on Appifix and kind of just the expectations for the year.
spk07: Yeah, so we haven't actually heard. I'm sure it's a fine product. We just haven't heard anybody use the product in the U.S. yet. I'm sure it's happening. But, you know, we are aware of the product internationally. I think it's been available for a number of years. But listen, I think our position on non-fusion surgery in general is that as other people enter the tethering space, it just drives awareness, patient awareness and surgeon awareness that non-fusion surgery for pediatric scoliosis is here to stay. It's going to grow over time. We view the market as fairly embryonic, so right, we're going to see new people enter. No one can compete directly with what we do, obviously on the posterior side, and much easier surgery. And now when you stack up results, albeit early, one-year results, but we stack those kinds of results up with the ease of use of this product, I think that's what's driving surgeons to start adopting the technology. You know, we added a number of new users. We have a number of sites that are applying for their first IRB to start using this product commercially. And, you know, I think this is a continuation. We think we'll see this product continue to grow as the marketplace grows. And the more people that enter the market, particularly on the anterior side of the surgical field, probably benefits us because it just raises awareness. And again, I think we stand by our claim here. We think this business has, you know, give or take doubles this year and probably does that again next year. And just really like this and like the results we're seeing.
spk11: Okay, got it. That's helpful. And then just on OpEx, it was, I think, mid-20s percent in the first half versus last year. It looks like a lot of that's, you know, R&D behind some new product launches and G&A. So, like, does that continue or can we see some more leverage in the model as we go into the back half?
spk10: Yeah, well, we'll see some more leverage in the back half of the year. It's really volume dependent, right? As the volume increased significantly second quarter to first quarter. we get some nice leverage. Dave mentioned earlier the, you know, lack of consignment on the non-bracing side. Those products are all sold basically through our e-commerce website, so we're not paying a commission on those bracing products, which gives us nice leverage on the sales and marketing side. R&D, we will continue to invest in that pretty heavily. And then on the G&A side, it's really the stock comp depreciation and amortization side. that's driving that. We're getting leverage on the cash side of G&A. So, yeah, we should see some leverage continue in the second half of the year and really into next year as we have different growth drivers, I guess, improving the top line.
spk11: Okay, got it. And then just a quick modeling question. What was the inorganic contribution in the quarter?
spk10: So, the only impact is Pega. So, Pega was purchased July... first of last year, and that was about a $6 million run rate business, so a million and a half-ish pre-acquisition. Okay, got it. Thanks.
spk18: Please stand by for the next question. The next question comes from Dave Turkley with JMP. Your line is open.
spk22: Great. Good morning. Can you hear me?
spk23: Just to clarify one up front here, the month-to-month comment, I'm assuming that's typical in 2Q, but it may not be. I understand that it sounds like it started slow and got a lot better, but is that typical for you in 2Q, or is that not typical in terms of how it progresses?
spk07: Yeah, Dave, let me clarify. It is typical to see that ramp. I guess what we saw is growth rates, the comparables were not normal, at least as it pertains to April. Normally, we see this nice, smooth ramp into June. And then obviously, June, July, August, those are our big months in terms of volume. But as we just look at what April did versus what April did prior year, and frankly, what April does prior years in the past, you know, we're still seeing that chop. That was what I was trying to point out is not that there wasn't a steady ramp into the year that was normal. It was just that what we saw in the month was pretty inconsistent with what we historically see in terms of kind of the growth rates that we would see over prior year. And then we saw almost complete reversal of that in May where, you know, revenue shot up and carried us into the summer. Does that make sense?
spk23: Yeah, totally. I get it. Thank you for that. And as a quick follow-up, you mentioned enabling technologies, you know, Firefly and 7D driving, even some response. I guess I'd just like to get your thoughts on how, you know, your docs are adopting enabling technologies. What you expected is, are they more willing? Is it, you know, are they conservative? And it's taken a little longer. Just any color you could give us in terms of, you know, how that initiative is rolling out. Thank you.
spk07: Yeah. There's no question that the pediatric orthopedic surgeons, particularly on the scoli side, are keenly interested in enabling technologies, and particularly on the spine side. You know, we see a real opportunity for that also on the trauma limb deformity side, which is why we really like this partnership. We think over time, you know, the partnership with C Spine 70 OrthoFix will allow us to, you know, to potentially get into the trauma and limb deformity side. So there's a big demand for that, certainly. I think the demand for navigation with very low radiation for pediatric patients is extremely high. I think one of the things that's held navigation back in the pediatric space is because historical navigation platforms involve so much radiation. And, you know, the pediatric patient absorbs a lot of that radiation, and it's not particularly good. And so now that there's a solution that is very low radiation, and frankly, it allows people in the operating room not even to have to wear lead, And, you know, a long surgery, that's a big deal. I think the surgeon feedback, healthcare provider feedback across the board related to the enabling technologies, particularly 7D, is very high. The only thing that I think we were a bit surprised by is, you know, we have never been in the capital market, capital equipment sales market. And so this is a bit new for us. And frankly, we were probably a bit naive in terms of how we thought that the hospital environment would allow for purchase or even consignment on contract some of these units. And so we've done a lot of work over the last year or so to put a lot of options in play. And we're starting to see, particularly Q2, and we think throughout the balance of the next year to 18 months, a number of these units that we have in sites start to go on contract from a consignment standpoint. And we even have some sales. And we have some sales pending, may not happen in Q3, But we're going to have some capital sales here, we believe, in Q4. And so, again, like what we see there, it's probably just maybe a little delayed in terms of not the surgeon adoption, but the hospital taking on the product and getting it going. Does that make sense?
spk24: Yes, and thank you for that. Sure.
spk18: Please stand by for the next question. The next question comes from Sam Brodowski with Truist Securities. Your line is open.
spk21: Hey, thanks for taking the question and congrats on a good quarter. Just the first one, just to put a finer point on it, were May and June sort of back to the normal inpatient dentist level that you're expecting or still a little bit of room to go there? And then just relating that to guidance. The second, I still assume that environment's going to be choppy in terms of patient volumes, right?
spk07: Yeah, so May and June, the inpatient environment still wasn't normal. You know, I think when we look at accounts where we would say, Sam, we have nearly 100% share, particularly on elective limb deformity and elective scoliosis, it's pretty easy to measure that. We just look at the volume, total procedures done, revenue generated, We see in a lot of those big accounts, and we cite these three places that were AppaFix accounts, but they're also ScoliFusion accounts. I mean, those accounts were, we had some accounts that were way off comparatively to prior year. And again, it's not, we didn't lose share in those accounts. And so, you know, it isn't normal, but it's better, right? It was better in May and June, and April was kind of an enigma for us. It was an odd month all the way around. So, no, we're not signaling that, you know, just that it certainly got better. It still wasn't running kind of full tilt like we would expect it to, you know, in the coming quarters.
spk21: Got it. Thanks. That's helpful. And then just one on the international scoliosis. Can you help us think about, you know, how big of an impact that could be? How much scale do you think you can have in 24 in international markets with scoliosis? And should we think about sort of the whole portfolio scenario? being launched nationally, including Apifix, or is that more just starting with some of the core products and then going from there? Thanks.
spk07: Yeah, so, you know, probably most people don't know, probably. I guess I realize that we essentially sell no scoliosis products in Europe right now. And we do sell Scoliosis, obviously, in Australia and South America, Latin America, and have a good business there. But, you know, the products, we had never really launched Scoli. Part of this is related to EMDR, right, and which products and what timing we were going to get EMDR approval. And so that's why we call that out. It's a good pickup, Sam, that we call this out that there's a number of products in Europe that are a number of products in the United States that are very well accepted here in the U.S. that are not sold in Europe because of pending approval related to EU MDR. And so we don't know the exact timing of when in 2024 the full portfolio would be approved, but it is a growth driver for us certainly as soon as that happens. as well as even into 2025 and 2026, where we have a lot of new products that will ultimately get introduced into our largest markets outside of the United States, scoliosis just being one. And so I don't know if the impact on the scoliosis of the overall business next year will be huge for scoli in Europe. It's certainly going to take some time to build, but it definitely will impact the scoliosis growth rate next year, even if that number's, you know, say a few million dollars. Now, with respect to Apifix outside of the U.S., we have actually pulled in accounts post-acquisition. The Apifix leadership previous had allowed some people to do some procedures outside of the United States through stocking distributors that we have, in fact, halted because we're trying to capture data and want to make sure that that data is good. So, we're a bit in the process of relaunching Apifix through our Scoliosis strategy. And again, we expect to see a very similar dynamic, right? Apifix brings customers to our product portfolio. We follow that up with response and the full portfolio and kind of pull that through. We expect those dynamics to be similar in major European markets. And again, not huge in 2024, but it will have an impact on the growth rate.
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