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spk07: Good evening, ladies and gentlemen, and welcome to ANACA's third quarter 2022 earnings conference call. Today's conference is being recorded. I will now turn the call over to Mark Namaroff, Vice President of Investor Relations, ESG, and Corporate Communications. Please proceed.
spk02: Thank you very much. Thank you, and good evening, everyone. Thank you for joining us for ANACA's third quarter conference call webcast. Our Q3 earnings press release was issued after the close of the market today and is available on our investor relations website, located at www.anneka.com, as are the supplementary PowerPoint slides that will be used for the discussion today. With me on the call today are Dr. Cheryl Blanchard, President and Chief Executive Officer, and Mike Levitz, Executive Vice President, Chief Financial Officer, and Treasurer. Please take a moment and open the slide presentation and refer to slide number two. Before we begin, please understand that certain statements made during the call today constitute forward-looking statements as defined in the Securities Exchange Act of 1934. These statements are based on our current beliefs and expectations and are subject to certain risks and uncertainties. The company's actual results could differ materially from any anticipated future results, performance, or achievements. We make no obligation to update these statements should future financial data or events occur that differ from the forward-looking statements presented today. Please also see our most recent SEC filings for more information about risk factors that could affect our performance. In addition, during the call, we may refer to several adjusted or non-GAAP financial measures. which includes adjusted gross margin, adjusted EBITDA, adjusted net income, and adjusted earnings per share, which are used in addition to results presented in accordance with GAAP financial measures. We believe that non-GAAP measures provide an additional way of viewing aspects of our operation and performance. But when considered with GAAP financial measures and the reconciliation of GAAP measures, they provide an even more complete understanding of our business. A reconciliation of these adjusted non-GAAP financial results to the most comparable GAAP measurements are available at the end of the presentation slide deck and our third quarter 2022 press release. And now, I'd like to turn the call over to our President and CEO, Dr. Cheryl Blanchard. Cheryl?
spk01: Thanks, Mark. Good afternoon, everyone, and thanks for joining us. Please refer to slide three as I review the third quarter highlights. As we near the end of the year, I'm pleased to reflect on Annika's continued journey toward becoming a global leader in joint preservation, one of the highest opportunity spaces in orthopedics. We accomplished much this quarter, including reporting the exciting results from the conclusion of our third phase three clinical trial for our next generation OA pain management product, SingSol. making significant progress towards completion of enrollment in the pivotal Phase III clinical trial for Hyalofast, our single-stage cartilage repair product, and receiving great surgeon feedback during the limited launch of our X-Twist fixation system for sports medicine soft tissue repair. We continue to make progress towards sustainable above-market growth and profitability, including increased year-over-year revenue growth. That said, it is no surprise that the sector and our business continue to be impacted by ongoing disruption from the macroeconomic environment in which we are all operating, which has continued to impact certain elective procedures and continues to cause supply chain issues across our business. Third quarter revenue was $43. million, up 2% from the same period last year. Driven by growth in joint preservation and restoration, which was up 6%, and by last-time buys of certain non-core, non-orthopedic products in the quarter. Our OA pain management revenues were down in the quarter based on J&J MyTech's order timing in the third quarter of last year, but that was offset in part by our international VSCO sales, which continued the strong performance in the third quarter that we saw through the first half of this year. While staffing and supply chain issues remain headwinds across our portfolio, we continue to benefit from our newer products, such as Tactuset, as well as from our market-leading HA-based OA pain management solutions with multi-injection OrthoVisc and single-injection MonoVisc in the U.S. and internationally, as well as our next-generation Singal product, currently only sold outside the United States. During the quarter, we were pleased to have J&J MyTech extend their license and supply agreement for OrthoVisc in the U.S. for another five years, positioning the company to continue our number-one market share and U.S. VSCO supplements through that strong ongoing partnership. We also continued to advance Singal toward U.S. commercialization and further geographic expansion. Singal is our next generation combination VSCO supplement and steroid injectable designed to provide both short and long-term osteoarthritis pain relief. Singal has been very successful internationally and is now sold in more than 35 countries outside the United States. We recently announced the exciting results of our third phase three clinical trial, Singhal 1901, which I'll discuss further shortly. With our transformational strategy, we are leveraging ANACA's more mature and profitable OA pain management franchise to invest in high opportunity adjacent spaces, including the larger and faster growing joint preservation market, where we're establishing a strong foundation for our multi-year growth strategy. As I'll discuss further, we believe our comprehensive portfolio is poised for outsized growth as we successfully manage through our supply chain challenges. We're confident that our strategy and approach to thoughtfully developing products targeting the highest opportunity spaces will deliver meaningful solutions for surgeons and their patients and significant value to our shareholders. As we have previously discussed, new product introductions are a key driver for our growth. In September, we announced the first surgeries using our X-Twist fixation system, a new addition to the ANICA sports medicine portfolio that addresses the needs of surgeons performing high-volume soft tissue repair procedures, such as rotator cuff repair and ankle stabilization surgeries. In addition, we've made significant progress in enrolling the pivotal Phase III clinical study for our single-stage cartilage repair product, Hyalafast. which I'm pleased to report is now 96% enrolled with 193 patients randomized between microfracture and hyalofast. We also continue to ramp up joint preservation medical education activities. We've held multiple events in the U.S., training more than 400 surgeons at in-person, hands-on courses since the beginning of the year, in addition to holding other key events, including training at major orthopedic meetings that have engaged an additional large number of surgeons. We continue to receive significant inbound interest from surgeons, including KOLs, in the product and technologies across our joint preservation portfolio and the differentiated value that we deliver to their patients. Most importantly, our medical education programs are enhancing technical and procedural confidence for our surgeons as they integrate our products into their practice and return patients to active living more quickly. Please turn to slide four. Just last week, we were excited to announce that Syngal successfully achieved its primary endpoint in a third Phase III clinical study, Syngal 1901, which demonstrated superiority of Syngal over steroid alone for OA pain reduction at 26 weeks. In studying a more difficult patient population compared to the prior clinical trials, the Syngal arm showed 66% improvement in the WOMAC pain index and 90% were deemed to be OMRAC-ORSI responders, which means they met certain threshold improvements for both pain and function at 26 weeks. Together with the two previous Phase III studies, Syngal has consistently proven itself to be a game-changing, next-generation product for osteoarthritis patients, and we believe the strong clinical data from all of these studies position us well to further advance Syngal. In fact, across the three completed phase three studies, Singhal has now demonstrated a mean 71% pain improvement from baseline and a mean 91% of subjects were deemed responders. Also across all three completed phase three studies, we have now demonstrated the superiority of Singhal over each of its active ingredients and saline placebo. These are remarkable results in this difficult to treat patient population that underscore the significant market opportunity for Syngal. We track this space closely and have yet to see another product that treats both short and long-term OA pain and yields such compelling clinical benefits. Based on our commercial success internationally and the strength of our clinical data, we remain highly confident in the differentiated clinical benefits that Syngal delivers compared to both the current treatment options on the market and products we see in development. Annika continues to control full global rights to Syngal, and we intend to proceed thoughtfully as we evaluate our options to continue to commercialize Syngal to best serve osteoarthritis patients around the world. We believe Syngal has the potential to address a true unmet medical need for the more than 32 million patients in the United States suffering from osteoarthritis. With an estimated next-generation OA pain management U.S. market opportunity of at least a billion dollars, and additional expansion opportunities internationally. We will be engaging with the FDA in the coming months regarding next steps for U.S. regulatory approval. While we're thrilled about our data foundation, our first step is to talk to the FDA to gain that clarity before we move ahead with further investments. In parallel, we're exploring the potential to advance Singdol through commercial partnerships in the U.S. and select Asian markets. These collective efforts will inform our work streams to advance Syngal, including if and how to proceed with another clinical trial in the United States. Please turn to slide five. As I mentioned, we had a successful limited launch of the X-Twist, which expands Anika's sports medicine portfolio with a cornerstone suture anchor system ideal for key repairs in the shoulder, foot and ankle, and other extremities. The system affords surgeons a variety of knotless and knotted soft tissue fixation options in a single anchor platform with the ability to support the surgeon's preferred combination of multiple sliding suture or tape configurations. The X-Swiss system also deploys ANICA's unique X-Spline drive technology, which provides for much easier anchor insertion relative to competitive systems, cutting the number of turns required for insertion by more than half. technology we intend to leverage across other anchor systems. The X-Twist is strong, easy to use, and supports healing, and can be used in nearly any soft tissue repair within the shoulder and throughout the body. Most importantly, it is uniquely suited for high-volume procedures such as rotator cuff repair and ankle stabilization surgeries, especially where we are focused in the ASC, where the majority of these cases are performed. X2S is a key growth driver in our joint preservation business, and we believe it has the potential to become a true platform technology as we look to leverage certain design elements in future products. The rotator cuff repair market in the U.S. alone is nearly $600 million across over 700,000 procedures performed annually, and we see significant expansion opportunities as we look to the future in this part of our business. Further, with the frequency of rotator cuff procedures performed, particularly in the ASC, ANACA has an incredible opportunity through these touchpoints with customers to truly begin to capitalize on the breadth of our innovative portfolio and drive a portfolio selling effect, especially in the shoulder. For example, we see X-twist pulling through tactoset usage in situations where surgeons encounter poor bone quality in the shoulder and pulling through ovomotion plus inlay glenoid from the joint solutions part of the portfolio. providing more frequent touch points with customers who do shoulder arthroplasty. This also paves the way for other exciting products to come in the shoulder as we move into 2023 and beyond. We're looking forward to the full launch of X-Twist in early 2023. It's the first of several Anika products launching across each segment in joint preservation, including Regenerative Solutions, Sports Medicine, and Arthrosurface, our joint solutions products. XTwist and its successful launch demonstrates Anika's commitment and ability to successfully develop, market, and commercialize products within our expanded $8 billion addressable global market. Please turn to slide six as I review our broader product pipeline. We continue to expand the market opportunity for TactiSET, our rapidly growing regenerative solutions product, which we launched in 2019. We remain focused on advancing our new product pipeline with multiple plan 510K filings targeting further Tacticet expansion, as well as a number of key shoulder solutions. The continued expansion of the Tacticet franchise will enable us to increase the addressable market to well beyond $100 million by creating a new market for hardware augmentation and expanding our existing insufficiency fracture Tacticet base with new products and indications. In addition to TactiSat, we have a cadence of multiple near-term product launches over the next 18 months across the largest and fastest growing parts of the joint preservation market. In shoulder repair, which is the biggest part of our portfolio today, we continue to launch innovative new products across categories and procedures. We've been making significant progress on several exciting new products. We're approaching first surgeries with new shoulder implants, which, like X-Twist, are in a high-volume segment of orthopedics. We already have the 510K clearance we need to move ahead with our limited launch, and we look forward to sharing a detailed update soon as our first surgeries are completed. Our regenerative rotator cuff repair system is also on track for 510K submissions later this year, and this system will further build upon Annika's growing and differentiated shoulder portfolio and leverage our regenerative platform. As I've discussed, rotator cuff repair procedures represent one of the highest volume soft tissue procedures in the ASC setting. A regenerative rotator cuff system, along with X-Twist now launching, will open up additional surgeon access and even more of this expanding market for Annika. We're building an innovative and winning shoulder portfolio ideally suited for the ASC, and this will drive growth in 2023 and beyond. All of these products will help accelerate growth as the supply chain challenges subside and reinforce the strength of our joint preservation portfolio. We have a balanced approach to developing our pipeline that includes 510 s and NDA and a PMA. We're delivering differentiated and meaningful products across the highest opportunity product categories in regenerative solutions, sports medicine, and joint solutions. The result is a portfolio that enables us to capitalize on ever-changing market dynamics continuing to meet the needs of surgeons in the ASC and hospital setting. Regarding longer-term opportunities in joint preservation, we're continuing to deliver steady progress towards enrolling the pivotal clinical trial for our single-stage cartilage repair product, Hyalafast, which I mentioned we are pleased to report is now 96% enrolled. Hyalafast delivers incredible benefits for patients and the healthcare system, As unlike the current cartilage repair solutions available or soon to be available in the U.S., Hyalofast is an off-the-shelf product that requires a single surgery and does not require removing healthy bone. We're excited about the significant market potential for Hyalofast, which will enable us to reach an addressable market that we have conservatively sized to be at least $350 million. We expect the trial to be fully enrolled in early 2023, and we remain on track to file a premarket approval with the FDA in 2025. Lastly, Singal is making tremendous progress toward U.S. approval, as I discussed previously. With our comprehensive portfolio of solutions, robust foundation of clinical data, and a regular cadence of new product launches planned for 2023 and beyond, we have a lot of important work underway at ANACA. We remain focused on continued strong commercial execution, and our hybrid sales organization is energized about the opportunities and value that our robust and growing product portfolio brings to our customers. We're confident that we're building and delivering the right joint preservation product mix that we need to win in both the ASC and hospital settings. Please turn to slide seven. Before I turn the call over to Mike for a review of our financials, I'd like to remind you of our transformation strategy. Since 2019, we have continued to grow and evolve our portfolio, expanding Anika's market opportunity from a billion to more than $8 billion today. We have taken our strong leadership position in the OA pain management market, which continues to generate a strong, steady cash flow, and actively invested in higher growth, yet highly complementary areas, building a joint preservation portfolio in regenerative solutions, sports, and joint solutions. Today, we have a broad, differentiated product portfolio, exciting pipeline, and experienced commercial team focused on the joint preservation continuum of care. This transformation has positioned Anika for accelerated revenue growth and significant value creation, despite the continued supply chain challenges that Anika and the broader industry continue to experience. These market dynamics and the supply chain challenges are particularly impacting our joint preservation business. While we see strong demand and potential across X-Twist and our other new joint preservation products, the supply chain has constrained the growth that we expected to see this year, but we are on a path to deliver steady supply for the full launch in early 2023. Please turn to slide eight so I can discuss where we are in the midst of our transformation strategy. We have maintained our market-leading position in the OA pain management market in the U.S. with OrthoVisc and MonoVisc. and advanced single for U.S. commercialization. Let me make some clarifying comments related to our U.S. VSCO supplement business. We have recently seen some other companies report out significant pricing changes and disruption to their VSCO businesses due to new federal legislation that was enacted earlier this year with respect to Medicare Part B ASP reporting requirements, which moved them from WAC to ASP-based pricing and reimbursement. The reimbursement for OrthoVisc and MonoVisc will not change under this new legislation because J&J MyTech, our U.S. marketing partner, was already reporting ASP for our products prior to the legislation being enacted. The requirements of this new legislation are expected to create a more level playing field for our products and will enable the selling dynamic in the market to be driven by our strong clinical data. We remain very pleased with this stable and growing part of our business. In 2022, we continue to make progress on key development programs to build our best-in-class product portfolio through advancing our product pipeline in regenerative, sports medicine, and joint solutions, and are focused on strong commercial execution. Over the last year, we've had successful product launches with TactiSet, Wrist Motion, and X-Twist. We're excited to get to our near-term product launches in the shoulder, as well as our longer-term opportunities with Hylafest and Singal, which hit key clinical milestones this year. This year we accelerated our in-person medical education activities and remained focused on delivering value to the ASC. And importantly, we have a healthy balance sheet with a solid cash position and no debt. I'll now turn it over to Mike for a review of our third quarter results, and then I'll wrap up the call and we'll open the line up for questions. Mike?
spk03: Thank you, Cheryl. Please turn to slide nine. I will now walk you through our financial results for the third quarter of 2022. Total revenue for the quarter was $40.3 million, an increase of 2% over the prior year, with the growth driven by joint preservation and restoration and last-time buys in non-orthopedic sales. Revenue in our largest product family, OA Pain Management, decreased 2% to $25.7 million due to ordering patterns from J&J MyTech with outsized transfer sales in Q3 of last year. This decrease was despite continued strong growth in our international disco supplement sales. As a reminder, revenues in OA pain management can vary significantly on a quarterly basis based on ordering patterns by our partners and distributors, both in the United States and internationally, more so over the last couple of years due to the global impact of COVID. But that quarterly volatility generally stabilizes on an annual basis. Our joint preservation and restoration revenue increased 6%, to $11.8 million on improved procedural volumes year over year. But that growth was limited in the period due to the market dynamics Cheryl described impacting the prioritization of elective procedures as well as supply chain challenges. Our non-orthopedic revenue increased to $2.8 million compared with $2.2 million last year on last-time buys for certain legacy products. Our gross margin in the third quarter was 57% and includes the impact of $1.6 million of non-cash acquisition-related expenses from the 2020 acquisitions of Arthur Surface and Parkes, as well as a product rationalization-related reserve of $2.6 million associated with legacy non-orthopedic products that we no longer expect to sell. Our adjusted gross margin, which excludes the acquisition-related expenses and product rationalization charge, was 67% in the third quarter, up from 66% last year. From a spending standpoint, our research and development and SG&A expenses together totaled $28.6 million in the third quarter, up 14% from $25.2 million in the same period of 2021, as we continue to invest in the development of key products and expand our internal capabilities in support of our growth objectives. The growth in the quarter included increased sales-related travel and medical education, which were largely curtailed last year as we emerged from restrictions on in-person activities. The increase in spending also reflected regulatory-related expenses in support of compliance with new MDR regulations that are going into effect in Europe, governing all products we expect to continue to sell there, as well as higher non-cash stock-based compensation expense driven in part by the growth in personnel to support ANACA's strategic transformation. Our net loss for the quarter was $4.2 million, or 29 cents per share, compared to net income of $600,000, or 4 cents per share, in the third quarter of last year. Our prior year results included a non-cash tax-affected benefit of $1.9 million, or 13 cents per share. associated with the reduction last year in fair value of contingent consideration associated with our 2020 acquisitions. Our adjusted net loss was $700,000, or 5 cents per share, down compared to adjusted net income of $800,000, or 5 cents per diluted share in the prior year, with the decrease primarily reflecting higher stock-based compensation, as well as incremental commercial investment to support ANACA's strategic transformation and growth acceleration initiatives. In the quarter, we generated adjusted EBITDA of $4.1 million. That's down from $5.7 million in the third quarter of last year and reflects the increased commercial spending, which had been largely curtailed last year due to the pandemic. We generated operating cash of $2.7 million in the quarter. That's up from $2.1 million in the third quarter of last year. And we made capital expenditures in the quarter of $1.7 million. up from $1.3 million in the same quarter last year. This resulted in free cash flow of $1 million in the quarter, up from $800,000 last year. During the third quarter, we paid $4.3 million to Parcus shareholders for contingent consideration associated with the 2020 acquisition of Parcus Medical. No further contingent consideration payments are expected. Anika's balance sheet remains strong with $87.8 million in cash, and no outstanding debt. Please turn to slide 10. Now I would like to review our full year financial outlook for fiscal year 2022. We remain on track to deliver revenue growth toward the upper end of our range of low to mid single digit growth. As Cheryl mentioned, supply chain and staffing challenges impacted our results in the third quarter, and they remain a risk to our guidance and our ongoing areas of focus for our team. While our overall guidance has not changed, the contribution mix has. In OA pain management, we are encouraged by our year-to-date performance and now expect mid to upper single-digit percent growth over last year. This improvement over our prior guidance of low single-digit growth is primarily due to our better-than-expected international sales that continued through the third quarter. While we believe this largely reflected order timing, and expect international sales to decrease sequentially in the fourth quarter, we now expect to end the year higher than we guided previously. In joint preservation and restoration, we've been pleased with the positive feedback from our limited market release and strong early demand for our new X-Twist sports medicine product. We are also seeing continued strong demand for Tactuset, our HA-enhanced regenerative solution for insufficiency fractures and hardware augmentations. Despite these positive dynamics that we expect to drive our long-term growth, there are two headwinds that are causing us to lower our current year guidance in this business. First, supply chain challenges have and will continue to limit our ability to fully meet the strong demand for X-Swift through year-end. And second, elective procedures that utilize our joint preservation products have not recovered as quickly as some other segments of elective surgeries. As a result, we are lowering our full year 2022 expected revenue growth in joint preservation and restoration to low- to mid-single-digit percent growth over last year, down from our previous guidance of mid-single- to low-double-digit growth. We expect accelerated sequential growth in the fourth quarter, in part reflecting normal seasonality, and we are actively ramping up supply to support the full market release of X-Twist in early 2023. In our much smaller non-orthopedic product family, we continue to expect revenues to decrease approximately 20% as compared to last year, down primarily due to higher results last year from last time buys of legacy products and order time. With regard to gross margin, despite ongoing supply chain and staffing challenges, due to the positive operational results year-to-date, we now expect full-year adjusted gross margin to be in the mid-60% range. That's up from our prior guidance of low to mid 60%. Our team has done a tremendous job delivering high-quality products for our customers as efficiently as possible in this current environment. With regards to spending, we continue to fund critical growth investments in research and development, as well as investments in our commercial transformation, such as medical education, industry events, building the ANACA brand and driving product awareness, and system and process enhancements. We are very excited about our new product development pipeline with a series of joint preservation products set to launch over the coming quarters, specifically targeted for the faster-growing segments of the market, beginning with the X-Twist full market release in early 2023. In line with our higher adjusted gross margin guidance, we are raising our expected full-year 2022 adjusted EBITDA margin guidance to mid-single-digit percent. That's up from our previous guidance of low to mid-single-digit. In summary, ANACA continues to demonstrate the value of its strong financial foundation in the midst of a challenging macroeconomic environment, enabling the company to take advantage of its exciting in-house portfolio of products and technologies to position for new product launches and accelerated growth in support of our multi-year growth targets. Our team remains laser-focused on both our mission to restore active living and driving value creation for our stakeholders. I will now turn the call back over to Cheryl.
spk01: Thanks, Mike. Please turn to slide 11 as I wrap up the call before we open the line up for questions. I would like to close by highlighting that ANACA is uniquely positioned for success with a strong cash position and no debt, robust foundation of clinical data, and a comprehensive portfolio of product and technology solutions and new product pipeline for osteoarthritis pain management, regenerative solutions, sports medicine, and bone-preserving joint technologies that we are delivering on. We have multiple near-term product launches, starting with XTwist, planned over the next 18 months, which will be important catalysts for growth and value creation in the coming years. While we expect some of the macro headwinds to continue in the near term, we have actively taken steps to position Anika for consistent, above-market growth and profitability. All of us at Anika are taking strategic and pragmatic steps to tackle the ongoing challenges head-on as we continue to deliver differentiated, high-quality products to our customers and their patience and drive value for our shareholders. I'd also like to take a moment to thank all of our employees for their dedication and hard work. It is because of their contributions that we continue to make strong progress on our evolution toward becoming a leader in joint preservation. And together, I look forward to achieving the many more milestones to come on our journey. Now we'll open up the line for questions.
spk07: Thank you. Ladies and gentlemen, if you'd like to ask a question, please signal by pressing star 1 on your telephone keypad. Using a speakerphone, please make sure your mute function is turned off to allow your signal to reach your equipment. Again, please press star 1. We'll pause a moment to give everyone an opportunity to signal for questions. We'll take our first question from George Sellers with Stevens Incorporated.
spk06: Please go ahead. Thanks for taking the question and congrats on a great quarter. I guess I want to start with sort of the underlying macro conditions and what you saw sequentially in the quarter and maybe also what you're seeing sort of quarter to date. You know, are there any areas of improvement in terms of the supply chain and maybe procedure volume and staffing shortages? And how should we think about that going forward? Thank you.
spk01: Hi, George, and thanks for the question. Yeah, let me make some comments on the macro conditions, and I'll start out with supply chain. I think we are, frankly, in the same boat that the broader market is in around supply chain. We see broad impact around supply chain with respect to things ranging from raw materials to key components, and we have teams of people that are micromanaging this on a daily basis. And frankly, I think that shows in our ability to deliver product. And while that can hit gross margin, frankly, we've even continued to drive reasonable gross margin, even in this difficult environment. So I would like to say that we see it starting to give us some relief, but I think across the business, we will continue to manage through supply chain issues for a bit of time to come. That said, on the joint preservation side of the business, where we've seen the largest impact, we do expect to see some relief coming, especially as we move toward full release of X-Twist in the early part of 2023. From a procedural basis, what we see are different parts of the market recovering faster than others, and specifically in orthopedics. And we've seen this with reports of the large market players in that space The hip and knee business is coming back at kind of high single-digit levels, but the sports extremity and trauma segments have not come back as quickly. And so that's really what we're referring to relative to the market dynamics.
spk06: Okay, that's really helpful. And then following up on the joint preservation and restoration commentary there, it It sounds like mostly what's driving the reduced expectations for this year is macro related, but is there anything else in there that we should be aware of in terms of what's limiting maybe that growth there and anything we should read into in terms of the growth outlook in 2023? Thank you.
spk01: Yeah, regarding joy preservation, we are incredibly optimistic and confident about that business. The the adjustment that you see for the rest of this year is really related to the supply chain issues that we just discussed and really being able to come up to, frankly, the demand that we're seeing in the market on XTwist. You know, the great news about XTwist is we've seen incredible feedback from the limited market release, and it's generated significant demand that we simply haven't been able to meet in this sort of the last part of the third quarter. And as we see demand continuing to ramp into the fourth quarter. We fully expect to have that issue addressed into early 2023 with the full release. So we remain excited. We are getting great feedback. It's a great product. And we look forward to being able to meet the demand around that supply chain issue in early next year. Mike, I don't know if you have anything to add to that.
spk03: Yeah, thank you, Cheryl. Hi, George. The one thing I would add is, as you mentioned, the macro environment is not just impacting supply chain, it's also impacting which elective procedures are being done. And, you know, as we've talked about what's going to drive our business over the coming years, it's these new products like X-Twist, like the shoulder-related new products and implants and regenerative. And those new products that we're introducing here over in 2023 and over the next 18 months targeted at the high opportunity spaces and so when you think about the macro environment we really are pleased that the areas that were coming out with innovative and differentiated technologies and products are those high opportunity spaces so that positions us for the accelerating growth as we go forward okay that's that's really helpful and then maybe if I could just squeeze one one last one in here
spk06: As we think about some of these launches in 2023, how should we gauge sort of expectations or what should we be thinking about in terms of the build-out from a sales perspective and a marketing perspective as well? Thank you.
spk01: Yeah, I mean, I think we're excited to be able to get to announcements on our next product launches. Obviously, we're RISC, Tactuset, X-Twist are all the recent ones we've announced. And I think that demonstrates our ability to develop great products, to really put together strong commercial programs, and frankly, training and education for the surgeons to really feel comfortable using them. So as we move into these next product launches in 2023, what we see is continued ability to execute on that work in a very successful way, given the demand that we've seen with what we've done so far, continuing to train on the safe and effective use of that product as we are able to drive that into the market and meet the demand that we're already seeing. And frankly, as we've talked about accelerated growth in 2023 and 2024, it's those new products in the JPR space that are really going to drive that.
spk06: Okay, thank you for the time, and congrats again on the quarter.
spk01: Thanks, George.
spk07: We'll take our next question from Mike Petusky with Barrington Research. Please go ahead.
spk08: Good evening. So a few questions. On Singhal, is there a timetable for speaking or meeting with the FDA at this point or a general hope that you guys have?
spk01: I mean, we expect that we'll be meeting with them in the next few months. I think that's a reasonable timeframe to expect based on the process that we're following, Mike. Okay.
spk08: All right. And then sort of switching over to JPR, on the supply chain issue, I mean, are there you know, mitigation efforts that you guys can take getting, you know, bringing in additional suppliers? Are there things that you can do on your end that can sort of mitigate these issues or not really?
spk01: Yeah, it's a great question. The answer is yes, and we have been. I will tell you, our teams are working like mad on a day-to-day basis, micromanaging the issues and That's why we are confident in our full launch timing for early 2023 and that we are on a track to be able to supply product for the full launch and frankly meet the demand that we have seen building in the marketplace. It's obviously very frustrating to not meet the demand that we have, but it's very exciting to have the demand and to know that we've got a great product so that when the supply chain issues are resolved, which are sadly, completely external to the company. But, you know, the folks at the company are working like crazy to address them. And so that's why we're bullish about that launch in early 2023 with full supply available.
spk08: Okay. And then just staying on JPR, when those assets were first acquired, I think the thought was that, hey, this business can be a double-digit grower. Obviously, it's, you know, due to a bunch of external headwinds, it's not going to be that in 22. But when you think about, and I'm not talking about 23, I'm just talking in general sort of three to five years, normalized backdrop based on what you believe. I mean, is this a Because when these assets were bought, the idea was this business will grow double digits. I mean, is that still sort of the internal belief there or, you know, any thoughts around that?
spk03: Yeah, Mike, this is Mike. Absolutely. We absolutely view this as a strong double digit growth part of our business. You know, one of the things that I think it's important to understand is we're moving from a historic business that it was a $1 billion addressable market to a much larger market. And we're a very small player with some really interesting differentiated technologies that now, as you look at the new products that are coming out, that we're going to be talking more and more about over the coming quarters. They're in, and you can see it in the slides, the call slides there. We talked about the sizable market opportunity, the $600 million plus market opportunity for the X-Twist just in rotator cuff, the $600 million market, and it's used in other parts of the body as well. And that's really a platform technology that we're going to be continuing to innovate on top of. The shoulder implants is an even bigger market. And so We're a small player in a very big market and have a real right to win. So, yes, I mean, I think we've been able to demonstrate strong growth when we've introduced new products. I mean, like Tactuset, we've talked about in the past about how much that's grown since 2019 and just this year. And if you look at this quarter, we had 30% growth roughly. So, I mean, it is a healthy product that's differentiated, that has a lot of room to grow, that being Tactuset. And then when you introduce a product like X-Twist where it comes right alongside Tactuset, now with the new hardware augmentation, capability in the shoulder. There's a lot of opportunity in this space, and that's why we're making the investments that we are.
spk08: Okay. Mike, you just ruined my last question. I was going to ask you, would you share how much taxes that grew in the quarter, but 30% or better, I guess. Thank you so much. Appreciate it.
spk05: Thanks, Mike.
spk08: Thanks, Mike.
spk07: We'll take our next question from Jim Sidoti with Sidoti & Company. Please go ahead.
spk04: Hi, good afternoon, and thanks for taking questions. And, you know, just to follow up, I've got to believe that there are people in ANACA that expect this to be a double-digit roller, you know, in a relatively near term. And 6% growth is nothing to sneeze at, but I think, you know, you guys are planning on getting to a faster growth rate pretty quickly. And to do that, what do you have to do? Other than the supply chain issues, do you think you have enough surgeons trained to And do you think that you'll have the products available in 2023 to start to hit those metrics?
spk01: Hi, Jim. Thanks for the question. The answer is that we do think we'll have the product available, especially around X-Twist. We do think that we are on track, and frankly, we are on track for those additional product launches. And we're excited to be able to talk about them as soon as we get to first surgeries here soon. And we think that we've got, you know, continued acceleration with training programs. We've trained a lot of surgeons, but we will continue to train at a faster and faster rate, especially as we launch those new products. That's key. And we think we've got the commercial team in place that is excited and ready to continue to drive those new products into the market. It is definitely true that the market dynamics here recently, and you can see this with the larger reporting companies, have been different in the sports and extremity space than they have in the larger hip and knee reconstructive space. That said, you're right, 6% was nothing to sneeze at this quarter relative to what we saw in the market. So we're excited, we're confident, and we think we do have everything in place to really drive that acceleration.
spk04: How about instrument sets? Do you have those available when these products come out?
spk01: Yes. And in fact, X-Swift comes with its own instrument set effectively. So it is an all-in-one deal. But there are other instrument sets that we want to make available to our customers so that we have greater mind share when we're in the OR and we're able to do a lot more cross-selling around with X-Twist and Tactuset and OvaMotion and Inlay Glenoid in the shoulder and in sports. So we continue to bring additional instrument sets, but also additional inventory so that we can be there in the OR with what they need.
spk04: And then with regard to Singal, you've completed three trials. I don't think there's any issue with safety. I think all three trials, that hasn't been an issue. You've shown superior performance now compared to the... existing products, both the OA alone and the steroids. What do you think the next hurdle you have to jump over to get approval?
spk01: It's a great question. We've talked about the fact that the FDA has changed the way they regulate this product from the start of our first clinical trial until where we are now. We are very confident about the data package that we will bring to discuss with them. There is an incredibly favorable safety profile. The safety profile is basically no different than HA alone, which is significant in this space and relative to some other studies that have been published on other products. And we have now demonstrated superiority to the two active ingredients and to placebo, which is what the FDA wanted us to do. So we are excited to bring that data package to them and have that discussion with them.
spk04: And has the most recent data, has that spurred any interest with your partners?
spk01: So we obviously have talked about the fact that we are interested in exploring potential partnership opportunities, both in the U.S. and in some select Asian markets where we don't currently sell Singal today. And we'll obviously give you an update if we move in that direction.
spk05: All right. Thank you. Thank you, Jim. At this time, I'd like to turn the conference back to Dr. Blanchard for any additional or closing remarks.
spk01: Well, thank you all very much for your attention and interest in ANACA. We look forward to speaking next on our fourth quarter year-end call in March, and I wish everyone a great night. Thanks.
spk07: Ladies and gentlemen, this concludes today's conference. We appreciate your participation. You may now disconnect.
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