Anika Therapeutics - Q3 2023

Transcript

Operator (participant)

Good evening, ladies and gentlemen, and welcome to Anika's Third Quarter 2023 Earnings Conference Call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your telephone keypad. To withdraw your question, please press star, then two. Please note, today's event is being recorded. I'd now like to introduce Mark Namaroff, Vice President, Investor Relations, ESG, and Corporate Communications. Please proceed.

Mark Namaroff (VP of Investor Relations)

Thank you. Good afternoon, everyone, and thank you for joining us for Anika's third quarter conference call and 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 anika.com, as are our 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 Michael 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 include 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 operational 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 measures to the most comparable GAAP measurements are available at the end of the presentation slide deck and in our third quarter 2023 press release. And now, I'd like to turn the call over to our President and CEO, Dr. Cheryl Blanchard. Cheryl?

Cheryl Blanchard (President and CEO)

Thanks, Mark. Good afternoon, everyone, and thanks for joining us. Please turn to slide three. We are pleased with our third quarter results, which underscore the strength of our strategy and reinforce our confidence in the powerful growth engine we've created. Following a period of purposeful investments to enable our transformation into the largest and highest opportunity areas of the joint preservation market, we are beginning to see the accelerated growth and momentum building across the business we've been working toward for some time. We delivered 14% growth in joint preservation and restoration in the quarter, and higher than expected growth in OA pain management, which has now grown 11% year-to-date. The acceleration in joint preservation and restoration is being led by our newest products, X-Twist and RevoMotion, which are gaining traction and generating a lot of interest in the markets we serve.

The double-digit growth in the quarter positions us well for Q4 and as we head into 2024. The continued growth in our OA pain business follows a strong second quarter, led by Monovisc growth globally and double-digit Cingal growth outside the U.S. Given the strong performance across our business, we are raising our revenue and EBITDA margin guidance for the year, which Mike will go into in a minute. Our expanding joint preservation and restoration portfolio has been key to our continued growth, and we achieved a number of important milestones in the third quarter. Our RevoMotion Reverse Shoulder Arthroplasty System had a very successful full market release in September at the OSET annual meeting in Boston, attracting strong interest from surgeons.

We also received the final 510(k) clearance from the FDA for our Integrity Implant System, and we're on track for full launch in the first quarter of 2024. As a reminder, Integrity is our truly differentiated, regenerative, HA-based patch system for the augmentation of rotator cuff and other tendon repairs. Our X-Twist Fixation System also achieved a significant milestone this quarter, receiving 510(k) clearance for the Biocomposite version, complementing the PEEK version that was released earlier this year. The clearance of X-Twist Biocomposite now allows Anika to address the full $600 million U.S. rotator cuff market. We are on track to launch the Biocomposite version in Q1 of 2024. We also reached a milestone in medical education, training over 500 surgeons this year across our full joint preservation and restoration portfolio.

We're pleased to see that OA pain management continues to outperform. This includes J&J's above-market growth and share capture as they continue to expand their number one market position in the U.S. OA pain management segment. Outside the U.S., Cingal has consistently delivered double-digit growth and is the next generation non-opioid osteoarthritis pain product of choice in over 35 countries. Cingal's highly differentiated clinical profile and its demonstrated real-world benefits have underpinned its international growth. We continue to explore Cingal partnership opportunities in the U.S. and select Asian countries with significant interest from several parties.

We're also continuing to engage with the FDA to advance Cingal towards U.S. regulatory approval. As a reminder, we had a Type C meeting with the FDA earlier this year, and we are awaiting feedback on our proposal to them on next steps to complete non-clinical work so that we can file an NDA as quickly as possible. We will continue to keep everyone updated on this process. Our Cingal market adoption and double-digit growth outside the U.S. reinforces that this next-generation product would be a meaningful addition to U.S. clinicians' arsenals to treat OA pain with a non-opioid product. On slide four, I'd like to spend a few minutes reviewing our Integrity system, which will be a key value driver for Anika and a game changer in how surgeons augment their rotator cuff and other tendon repairs.

Integrity's key differentiating feature is the inherent structural integrity of the hyaluronic acid-based scaffold compared to the current collagen patches on the market. The strength comes from its HA-based hybrid structure, resulting in a patch that is over 50% stronger than the leading collagen patch in tensile strength, suture retention, and tear resistance, even when hydrated. That provides for the ability to confidently manipulate the patch intraoperatively and strongly affix it with staples, tacks, or suture during the repair. Another key value driver for Integrity is in its regenerative capacity. The hyaluronic acid scaffold supports healing through improved cell infiltration, tissue remodeling, and tendon thickening. In a head-to-head animal study, the Integrity patch demonstrated about 3x the regenerative capacity compared to the leading collagen patch. This data is important to both the surgeon and the patient.

The combination of Integrity's strength, increased regenerative capacity, and an efficient, reproducible delivery system is what is getting surgeons really excited. We are feeling a pull from surgeons excited for Integrity to launch. We're confident that it will become the standard of care in rotator cuff augmentation, and along with our recently launched RevoMotion and X-Twist, position us to drive growth for years to come. Please turn to slide 5. We've been investing with purpose to establish Anika as a global leader, addressing unmet needs in early intervention orthopedics. We are leveraging our core expertise in hyaluronic acid and portfolio across OA pain management, regenerative, sports medicine, and Arthrosurface joint solutions. The investments we've made over the past three years are now beginning to bear fruit.

In fact, most of the products on this slide are either launched or are launching in the first quarter of 2024 into larger markets than Anika has entered before in our direct business, setting up 2024 as an exciting year. In addition to those products, our value-driving Cingal and Hyalofast products have now advanced and are closer than they have ever been, with line of sight to U.S. regulatory filings for both products. We expect the next generation OA pain market served by Cingal adds an additional $1 billion-plus to our existing $1 billion market opportunity served by Monovisc and Orthovisc, and Cingal is perfectly positioned to win. Hyalofast addresses the $1 billion-plus cartilage repair market with a single-stage, off-the-shelf regenerative product.

Now that we are fully enrolled in our pivotal trial, this breakthrough device has a well-defined pathway to launch in the U.S. market by 2026. In short, our highly differentiated new product pipeline is being realized. On slide six, I'll discuss our focus on commercial execution and profitability. Anika has a long history of generating strong profitability and cash flows. We've used these cash flows in recent years to significantly expand Anika's market and growth opportunities, with key new products and critical internal investments to support sustainable long-term growth and our commitment to growing profitability. With the 2023 full market launches of RevoMotion and X-Twist PEEK, and the 2024 launch of Integrity and X-Twist Biocomposite, we're expecting sustained double-digit growth in joint preservation in 2024 and beyond.

We are also confident in the continued above-market growth of our core OA pain management products, led by Monovisc globally and Cingal outside the US. With the investments we've made in R&D, scaling the business, and addressing MDR, we're now focused on actively managing our OpEx while still supporting the significant growth and profitability acceleration in the coming years. As spending stabilizes, we are shifting the investments we do make toward commercial execution as we begin to establish a very targeted direct sales force going into 2024. These hires will be focused on regenerative solutions and sports medicine products to augment our hybrid sales channel and penetrate underperforming accounts and geographies. The hybrid channel is a cost-effective model and works very well where distributors are focused on our products.

The direct reps will strengthen the areas where we can drive better focus and commercial execution to deliver on the significant growth opportunity in front of us. These investments to augment our hybrid sales force with targeted direct sales reps are thoughtfully timed with the launch of our newest products, such as Integrity, X-Twist, and Tactoset expansion. At the same time, and to be clear, we are committed to keeping total company costs stable as we leverage the investments we've already made to develop and launch these exciting new products. In summary, we continue to have a strong balance sheet with a healthy cash position and no debt, and with our meaningful accomplishments this year, are confident as we move forward to realize the significant opportunity in front of us.

Now I'd like to turn the call over to Mike to review the third quarter results and our outlook for the remainder of the year. Mike?

Michael Levitz (EVP, CFO, and Treasurer)

Thank you, Cheryl. Please turn to slide seven. I'll now walk you through our financial results for the third quarter of 2023. I'm pleased to report total revenue for the quarter grew to $41.5 million, exceeding our expectations, driven by accelerated double-digit growth in joint preservation and restoration, and better-than-expected growth in OA Pain Management. Our results also reflected the lower non-orthopedic revenue we discussed in prior quarters, following our planned exit from the product lines that did not fit our profitability objectives. The lower non-orthopedic revenues reduced total company growth in the quarter by approximately three percentage points. Our joint preservation and restoration revenue increased 14% in the third quarter to $13.5 million.

This accelerated growth was driven by our recent product launches in the United States with X-Twist and RevoMotion, and by strong international growth, some of which reflected favorable order timing. Through the first nine months of this year, joint preservation revenues have grown 10% compared to the same period of 2022, a nice acceleration from historic growth rates, as we see the early benefit of our recently launched products in the United States, as well as continued international growth. Revenue in our largest product family, OA Pain Management, increased 2% to $24.9 million on increasing above-market global customer demand, offset by lower transfer units in the quarter on order timing, following a high second quarter.

Through the first nine months of the year, our OA Pain Management revenues have grown 11% compared to the same period of 2022 on rising global demand led by Monovisc in the United States and both Monovisc and Cingal outside the United States. As expected, our non-orthopedic revenue declined 22% to $3.1 million and is down 34% year to date, reflecting the continued impact of our exit from legacy product lines that do not support our growth and profitability objectives. Our gross margin in the third quarter increased to 60% and includes the non-cash impact of $1.6 million of acquisition-related amortization expense from acquisitions made in 2020, as well as product rationalization reserves of approximately $750,000 associated with legacy non-orthopedic products we no longer expect to sell.

Our adjusted gross margin, which excludes the non-cash acquisition-related amortization and product rationalization reserves, was 66% in the quarter, down from 67% in the same quarter last year, as higher costs were largely offset by favorable product mix and improved operating efficiency. From a spending standpoint, our operating expenses totaled $32.6 million in the third quarter, up from $20.6 million in the same period of 2022, primarily due to a $4.5 million non-recurring charge in the quarter associated with the discontinuation of a software development project. Excluding this charge, our operating expenses were lower than last year on continued expense management as we approach the completion of the development and launch readiness of our new FDA-cleared products in support of their planned launch in the first quarter of 2024.

Our net loss for the quarter was $6.6 million, or $0.45 per share, compared to a net loss of $4.2 million, or $0.29 per share in the third quarter of last year. On an adjusted basis, net income improved to break even, up from an adjusted net loss of $725,000 or $0.05 per share in the prior year, reflecting growth in the business and spending management. Anika generated adjusted EBITDA in the quarter of $4.7 million, up from $4.1 million in the third quarter of last year, and our adjusted EBITDA margin in the quarter was 11%, up from 10% in the same period last year.

Lastly, with regards to our cash flow and capital structure, we generated operating cash flows of $6.5 million during the third quarter, up from $2.7 million in the same period last year on growth in the business and spending management. Our capital expenditures in the quarter were approximately $700,000 and primarily reflected investments in instruments in support of our key new product launches, such as RevoMotion. We ended the third quarter with $70.7 million in cash and no outstanding debt. Anika maintains a healthy balance sheet and is well positioned to continue to self-fund our growth initiatives to drive shareholder value. Please turn to slide eight. Now, I would like to review our updated financial outlook for fiscal year 2023.

Based on our results to date and current momentum, we are raising our full year guidance with an updated total company revenue outlook for fiscal year 2023 of $164 million-$166 million, representing growth of 5%-6% over 2022 on above-market growth in OA Pain Management and accelerated growth in joint preservation and restoration, offset in part by lower non-orthopedic revenues. The lower non-orthopedic revenues are expected to reduce total growth this year by approximately four percentage points. As such, excluding non-orthopedic, Anika's revenues are expected to increase 9%-10% this year over 2022. In OA Pain Management, we now expect revenue of $99.75-$101 million, up 8%-10% over 2022, as our market-leading products continue to gain adoption globally.

This outlook is up over $3 million from our previous range of $96 million-$97.5 million on the strong progress year to date and positive momentum globally, and positions this core part of our business to reach a key milestone of $100 million this year. In joint preservation and restoration, we now expect revenue of $54.75 million-$55.5 million, up 9%-10% over last year, an acceleration due primarily to our new product launches in the United States, as well as continued growth internationally. Our previous range was $54 million-$55.5 million. We continue to expect non-orthopedic revenue of approximately $9.5 million. That's a decrease of just over 30% from last year, primarily due to last-time buys of legacy products and veterinary order timing in 2022.

We continue to expect adjusted gross margin for the year to be roughly in line with the 65.9% we reported last year. Based on the higher revenue guidance, we are also raising our adjusted EBITDA margin guidance for the year to 6%-8%, up from our previous guidance of low single-digit. We continue to manage operating expenses prudently as we've expensed some non-recurring costs in the first three quarters, primarily associated with the settlement of Parcus Medical arbitration, shareholder activism, and discontinuation of a software development project.

As we look ahead to 2024, based on our recent and upcoming product launches and with the momentum we saw in the third quarter and are seeing as we move now into the fourth quarter, we expect 2024 to be a year of above-market revenue growth, led by double-digit growth in joint preservation and continued above-market growth in OA Pain Management. With the growth in revenue and stabilized spending, now that X-Twist, RevoMotion, and Integrity are all FDA cleared and on or coming to the market, we also expect to increase our adjusted EBITDA margin and bottom line in 2024, approaching break-even adjusted net income, which turns positive when excluding non-cash stock-based compensation. We look forward to providing additional details on our normal schedule as part of our year-end earnings call.

In summary, as we head into the fourth quarter, we are pleased with our growing momentum, which is reflected in our increased revenue and EBITDA margin outlook for the year. We remain focused on delivering growth and operational execution to position Anika for long-term success. I will now turn the call back over to Cheryl.

Cheryl Blanchard (President and CEO)

Thanks, Mike. Please turn to slide nine before we open up the call for Q&A. We're excited about the acceleration and growth of our joint preservation and restoration portfolio as our new products gain market traction, and we see our strategy in action. We are also pleased with the expansion of our market-leading OA Pain Management products, both in the U.S. and O.U.S. With the strength of our growing, differentiated, HA-based regenerative portfolio, as well as our value creation opportunities with Cingal and Hyalofast, Anika is very well positioned for and committed to continued top and bottom line growth in the years to come. Importantly, we have self-funded this transformation and continue to maintain a healthy balance sheet with a solid cash position with no debt.

I'd like to take a moment to thank all of our employees for their continued hard work and dedication to supporting our efforts as we build Anika into a leader in joint preservation and restoration. Together, we are driving real momentum as we work to achieve our mission of restoring active living for people around the world. With that, we'll open up the line for questions.

Operator (participant)

Thank you. If you'd like to ask a question, please press star then one on your telephone keypad. If you'd like to remove yourself from queue, please press star then two. Today's first question comes from Mike Petusky with Barrington Research. Please go ahead.

Mike Petusky (Managing Director and Senior Research Analyst)

Hey, good evening. Congratulations on some of this progress. I guess, Cheryl, I wanted to ask, you know, on the last quarter's call, you guys talked about, you know, maybe some disappointment around some distributors, maybe not driving as hard to the hoop as you would like. I'm just curious, sort of what, what's the status of sort of your distributor base relative to where it was 90 days ago? And could you just talk maybe in whatever level of detail you can, about the investments you're planning on making and sort of the timing of all that? Thanks.

Cheryl Blanchard (President and CEO)

Absolutely. Thanks, Mike. I appreciate the question. Yeah, we've done a lot of work around really understanding the hybrid model that we've chosen to deploy, for obvious reasons. It addresses not signing up for the full fixed cost of a fully direct sales force for a business the size we are. At the same time, you know, there are compromises that you make in doing that because you go to 1099 distributors that are not necessarily fully focused on you. I'll tell you what we do see is we have a very large number of distributors that are very focused on us, and they are growing the business very nicely, as we would expect them to, and really driving those opportunities as we see the possibilities to do.

What we have seen, though, are some other distributors that are really not taking advantage of getting these great products out. We know that the surgeons love them when they see them, and so we've taken the approach using some pretty careful data analytics to understand those situations and specific geographies to make sure that we kind of use a very focused approach to hiring some truly direct sales reps, and those folks are going to be focused on sports medicine and regenerative solutions. So a portion of our portfolio. And again, I you know I want to highlight that this is a limited move that we're making to really make sure that we take advantage of specific geographies where we're just not seeing the kind of growth that we're seeing everywhere else.

We've started the hiring process, and we see ourselves moving into next year before we're sort of fully up and running with that. I'm not gonna speak to the specific numbers, but it is a very focused effort, and we feel like it's something we're really excited to be able to get that focus with sports med and regenerative solutions.

Mike Petusky (Managing Director and Senior Research Analyst)

Will, will that change the number of, like, I guess, I don't know if you call them sales managers, but essentially, the folks that currently manage the distribution relationships? Does this strategy at all change those numbers, as you sort of look out?

Cheryl Blanchard (President and CEO)

No, it doesn't. And, you know, the reason for that is those folks are managing across the distribution network, including the Arthrosurface. And we have a lot going on with that, with the recent product launch of RevoMotion. So, you know, we'll continue to work to drive the current hybrid sales force that we have while we take this opportunity to have some very focused additions in driving those additional geographies in sports and regenerative solutions. And we are—I will comment that we're, you know, we've committed that we won't be—we're really shifting our focus now in terms of the investments we are making to commercial execution, so we're not adding to OpEx by doing this.

Mike Petusky (Managing Director and Senior Research Analyst)

I appreciate it when you said that in the pre-prepared remarks, but I think it's a good reminder for everyone. Thank you.

Cheryl Blanchard (President and CEO)

Yeah.

Mike Petusky (Managing Director and Senior Research Analyst)

So, I did wanna ask real quick, Cheryl, on the Integrity patch.

Cheryl Blanchard (President and CEO)

Mm-hmm.

Mike Petusky (Managing Director and Senior Research Analyst)

You know, obviously, I know, I know you guys are excited about all the new products, but, you know, essentially saying, "Hey, confident this could be standard of care." I mean, could you just talk about, you know, I guess, why you have that confidence, and, you know, is this the kind of product that, you know, could actually, you know, make a material impact as early as, you know, full year 2024? Thanks.

Cheryl Blanchard (President and CEO)

Yeah, I'll tell you, the confidence comes from a number of things. We really put some significant energy toward ensuring that we were coming up with a product that addresses true unmet clinical needs. And one of the big pieces of feedback we heard from clinicians was the existing first-generation collagen patches that are in the market today just don't provide the kind of strength, or suture retention strength, especially when it gets wet, which it does immediately intraoperatively. So we addressed that. We also hear that there's obviously always a greater need for increasing the regenerative capacity. We've addressed that. There was also a lot of feedback around simplifying surgical technique and instrumentation and fixation to give the surgeon the ability to be efficient and confident in the repair. And so we've really come at it from all directions.

We've done a number of labs with already a number of surgeons, and the labs have gone incredibly well, and we're really feeling a pull from the surgeon community to get this into their practice. So that's really what our confidence is based on.

Michael Levitz (EVP, CFO, and Treasurer)

And Mike, I'll speak to the other part of your question around the impact in 2024. We'll get more, you know, direction on 2024 in our normal schedule. But as Cheryl said, and I said, we expect double-digit growth to be continuing here in 2024, and Integrity plays a real solid role in that. We're excited that that product remains on track to launch in the first quarter. We were very pleased to be able to get the clearance when we did so that we could get everything set to launch here in the first quarter. We're cognizant it's a new product, and it, you know, it's going to take a normal ramp that you would expect for a new product.

But the team's very excited, as Cheryl said in her comments. We really are seeing the pull from the surgeon community, and we're seeing it from our distributors. And so, we're being very thoughtful about how we're gonna roll that out, but we do expect it to be a meaningful driver of the double-digit growth next year.

Mike Petusky (Managing Director and Senior Research Analyst)

Okay. And then, Mike, I guess just a last one for me for now. So your commentary on adjusted EBITDA, I think, I think I heard you say 6%-8% this year, and then some number higher than that range next year. Was that what you actually meant to say, or did I not follow that right?

Michael Levitz (EVP, CFO, and Treasurer)

Yes, Mike, you have that correct. I said that our expectation was low single digit this year. We have raised it now, with our progress to date, to 6%-8% is the range for this year, and we expect it to increase next year. You know, we need to see as we go into next year, we'll hopefully get that feedback from the FDA. We may have some things that we wanna focus on here to drive Cingal, but even with all of the different things we're doing next year, now that we are stabilizing the spending and driving the growth from the products that we have now launched, and are launching earlier in the year, we feel confident to say that we'll be expanding our, EBITDA margin next year, even as we drive the revenue growth.

Mike Petusky (Managing Director and Senior Research Analyst)

Hey, one quick housekeeping, if you have it in front of you. Is there any chance you have the CapEx beyond this $0.7 million, like $728,000? Do you, by any chance, have that exact figure?

Michael Levitz (EVP, CFO, and Treasurer)

The exact figure was $680,000.

Mike Petusky (Managing Director and Senior Research Analyst)

$680. Perfect. Thanks, guys.

Michael Levitz (EVP, CFO, and Treasurer)

Thank you.

Cheryl Blanchard (President and CEO)

Thanks, Mike.

Operator (participant)

Thank you. Thank you. And our next question comes from George Sellers with Stephens Inc. Please go ahead.

George Sellers (VP and Equity Research Analyst)

Hey, thanks for taking the question, and congrats on a good quarter.

Cheryl Blanchard (President and CEO)

Thanks, George.

George Sellers (VP and Equity Research Analyst)

Maybe to start with the joint preservation and restoration segment in the quarter, could you just give some additional details on the contribution from X-Twist? And you noted RevoMotion contributed as well in the quarter. Just curious how material that contribution is. And then, as a follow-on to that, for the raised guidance, how much of that is related to the launch of RevoMotion? Thank you.

Michael Levitz (EVP, CFO, and Treasurer)

Hi, George, this is Mike. So, first, the first part of your question around the contribution from X-Twist and RevoMotion. That was the primary driver of the growth in the quarter. And we, I would say that that's what drove us to double-digit growth. We also saw a really strong international revenues in joint preservation in the quarter. Now, I will say that some of that is timing. You know, we've talked about this in previous quarters. That part of our business is through distributors, and so sometimes you can get lumpy quarters.

And so we had a strong first quarter and then a lower second quarter, a strong third quarter here, and you know, so that is a lumpy part of our business, but that is a nice growth part of our business for the full year. So that is what the primary driver of the growth was, X-Twist and RevoMotion together. You know, it's nice to now we've been on the market since the first quarter with X-Twist PEEK, and are excited to see X-Twist biocomposite coming on in the first part of next year. RevoMotion, as we said, moved into full market release in September, and we're seeing growing momentum there. Can you remind me the second part of your question?

George Sellers (VP and Equity Research Analyst)

Yeah, just curious on the increase in the guidance, how much of that is related to the full commercial launch of RevoMotion?

Michael Levitz (EVP, CFO, and Treasurer)

Okay. We increased the guidance across the business. So the increase in the guidance on OA Pain Management, which we increased over $3 million, was driven by the performance year to date and the expectations in the United States, led by Monovisc, and internationally, led by Monovisc, but mostly by Cingal, where we continue to see double-digit growth. So that was the biggest driver of the increase, but we also raised the low end of our range in joint preservation, now that those products are, like, RevoMotion is now launched and on the market, and, you know, we've retired risk associated with those new products. So, we're seeing growing momentum for the X-Twist, and again, we just launched the RevoMotion full market release here in September.

George Sellers (VP and Equity Research Analyst)

Yep. Okay, that, that's really helpful. Thank you for that color. And then maybe a question on the Integrity Implant System. How many of your current surgeon customers are already using a rotator cuff patch system? Obviously, a different one, but how many are already using that device? And I guess I'm really trying to figure out, you know, what the cadence of that growth and revenue contribution might be in 2024.

Cheryl Blanchard (President and CEO)

Yeah, George, it's a fairly significant number that are currently using some patch. I mean, there is one patch that is the market leader, and that's frankly, primarily what anybody is using right now. In terms of our ramp, I mean, we are having very good meetings with surgeons right now who are very excited to get this into their practice. It's not uncommon for a product like this for surgeons to want to do a couple, see how their patients do, wait a few months before they fully adopt it, kind of, you know, learn, go to some training and education, make sure they're serving their patients well, that they're very familiar with the system. So I think we're expecting to see adoption over the next year as we get this launched in Q1.

But again, I think there's a real understanding that this product addresses some pretty significant unmet needs that they all have, and they're very excited to get going with it.

George Sellers (VP and Equity Research Analyst)

Okay, that, that's really helpful. And Mike, maybe one on OpEx. Clearly some good cost controls going on from y'all's perspective. I'm curious, as we look ahead, is the third quarter a good sort of run rate going forward on both the SG&A line and also the R&D line, as you sort of maybe switch out some MDR-related costs for some direct sales rep costs?

Michael Levitz (EVP, CFO, and Treasurer)

Well, first, I'd say, yeah, we are pleased to be able to drive savings on the OpEx side. And we are expecting our OpEx to stabilize here as we look into 2024, and that's what's going to drive the bottom line as we grow the business. In terms of the quarterly phasing, there were a couple of things in the third quarter that were not normal phasing within OpEx. One was we took a charge, there was no cash in the quarter, but we took a charge for a software project that we discontinued. And, that project had stalled, and we had the opportunity to make other process improvements and system improvements to be able to drive some savings by making that decision.

So that was in the quarter. That was $4.5 million. And then the other thing in the quarter is, we have been making some changes around the business. We had some forfeitures on the stock compensation side of about $400,000 in the quarter. And so that was reflected in Q3. In terms of the specific quarterly phasing of R&D, that can be lumpy from a quarter-to-quarter basis, just depending upon some of the work. We are pleased with how we've been wrapping up the MDR and having real success in getting through that process to date.

So we expect that MDR is going to continue to be less of a part of our story from an investment standpoint because of the successes we've had so far in retiring that. But Integrity is not yet finished and not yet launched. That's going to launch here in the first quarter. And so, you know, those kind of wrap-up costs and whatnot will continue through the end of the year, and then we'll start to see that coming down next year. So I hope that's helpful direction.

George Sellers (VP and Equity Research Analyst)

Yep, that's really helpful. Thank you all for the questions. I'll hop back in the queue.

Cheryl Blanchard (President and CEO)

Great.

Operator (participant)

Thank you. Our next question comes from Jim Sidoti with Sidoti & Company. Please go ahead. Hi, Jim, your line might be muted, sir. Mr. Sidoti, are you there?

Jim Sidoti (Analyst)

Hi. Sorry about that. Can you hear me now?

Cheryl Blanchard (President and CEO)

We can. Hi, Jim.

Jim Sidoti (Analyst)

Okay, great. So I was just following up on that, comments about the software charge. Is that primarily in SG&A?

Michael Levitz (EVP, CFO, and Treasurer)

Yes, it is.

Jim Sidoti (Analyst)

Can you just give us a little detail? What, what was the software that you were developing that you, you stopped?

Michael Levitz (EVP, CFO, and Treasurer)

It was support software on the commercial side, and it was a multi-year project, and the project had stalled, and we made the decision as we, you know, look, we're constantly looking across the business at where we're allocating our resources, and it made sense to not spend more money to pursue that. Because we found that we were able to drive operational process improvements, and also use the systems that we already have in place, to have a more cost-effective solution. And so, that's why we made the decision this quarter, to discontinue that software project.

Jim Sidoti (Analyst)

Okay. And then, the sales team, can you give us some sense on how many folks you expect to bring on and how quickly you think, or how long it'll take for them to ramp up?

Cheryl Blanchard (President and CEO)

Yeah, Jim, I'll tell you, we've already started hiring. This is very, very focused and targeted. It's really gonna be to augment the hybrid sales force. It's gonna be focused just on regenerative and sports and just in a few geographies where we're just not seeing the kind of performance that we're seeing everywhere else in the country. So I think we'll, you know, we'll be providing more updates on that as we go forward, but the process has begun, and it'll continue into next year.

Jim Sidoti (Analyst)

All right. And then, you know, if you look at the quarter, you reported 14% growth for joint preservation, and that's without any contribution from the new sales folks. And you're very early in the launch cycle for Integrity and RevoMotion and X-Twist. So is it fair to say that you—I know you said double-digit growth, but that's a pretty general term. Would you be disappointed if joint preservation didn't accelerate from the 14%?

Michael Levitz (EVP, CFO, and Treasurer)

Jim, it's Michael. I'll take that question. We're very pleased, given, as you said, how early we are with these new product launches, to see that 14% growth number. And that growth was... The double-digit nature of that growth was driven by the new products. That being said, we also benefited in the quarter from strong international sales, and some of that is timing because of the lumpiness of that business. And so, that's why that's reflected in our guidance for the year of 9%-10% growth for the year in joint preservation. So, we'll give more clarity around the full year guidance in terms of specifics next year. But I think the key takeaway from our perspective is, it's great to now have these products on the market.

It's great to see the initial feedback that we're getting. It is still early, but we're excited for what that can ramp, and we do expect that to be a double-digit growth here in 2024 in joint preservation.

Jim Sidoti (Analyst)

Okay. All right. Thank you.

Cheryl Blanchard (President and CEO)

Thanks, Jim.

Operator (participant)

Thank you. Our next question today is a follow-up from George Sellers. Please go ahead.

George Sellers (VP and Equity Research Analyst)

Thanks for the additional question. I'm just curious, as we think about 2024 and nearing that break-even net income point, how much of that margin improvement is related to positive mix associated with some of these new product launches versus just maintaining the cost controls that you mentioned earlier?

Michael Levitz (EVP, CFO, and Treasurer)

That's a great question. You know, if you look at where we're trending right now, and we hit break even this quarter. So, you know, I think we've demonstrated, you know, that, you know, that's. We have line of sight to doing that. I think, we have a lot of, lot of exciting things happening in 2024, and we're expecting that revenue growth, to be healthy, as we said. I think, you know, it's a good question. The new products are, are all within that higher gross margin level, in line with our multi-year targets. And so as those new products, continue to ramp, that is very helpful to us from a mix perspective. You know, I think that, managing the cost side also matters too.

So I think, you know, it's just, we're not that far, frankly, from doing that right now. I think it's a combination of the growth. Having finished what we needed to finish in driving these new products, we can now manage the spending. And so, I think it's within our control to deliver on those results, now that we've done the work that we did here in 2023.

George Sellers (VP and Equity Research Analyst)

Okay, great, and thank you again for taking the additional question.

Cheryl Blanchard (President and CEO)

Thanks, George.

Operator (participant)

Thank you. Our next question is a follow-up from Mike Petusky at Barrington Research. Please go ahead.

Mike Petusky (Managing Director and Senior Research Analyst)

Thanks. Yeah, just a couple quick ones. I guess, sort of cool, Mike, to see the cash balance go up and the free cash generated in the quarter. And I'm just wondering, as you sort of look out, you know, with seemingly a bunch of positive things that are converging here, I mean, would your hope be that positive free cash is gonna be sort of a regular part of the story going forward?

Michael Levitz (EVP, CFO, and Treasurer)

Well, first of all, I'll say, yeah, we were very pleased with the growth in cash in the quarter. And I think it reflects the health of the business. In terms of specific cash guidance, I think what I want to say is a couple of things. I think, first of all, we talked about the improving profitability next year. That will definitely help on the cash side. Again, we're in a good solid place this year. If we didn't have the non-recurring charges we had this year and the spend on associated with that, you know, we're in a good place already, and we believe we're improving next year from that.

The other things that will impact cash next year, in part, some of it depends upon Cingal and what that timeline is going to be, because you know, we may need to make some investments to be able to support the manufacturing of that. Again, we'll need to see how that timeline comes out in our interactions with the FDA. But apart from CapEx, you know, I just- so I feel more comfortable giving qualitative guidance at this point, as opposed to quantitative, but it's all moving in the right direction.

Mike Petusky (Managing Director and Senior Research Analyst)

Great. And then just one more. Obviously, you're getting some questions on, you know, Integrity and, you know, how quickly that can ramp. And I, I'm sure everybody's sort of curious about the, you know, what was the actual, you know, the actual contribution of RevoMotion, X-Twist, et cetera, in the quarter. Is, have you guys given any thought as you look at 2024 and, and how you guys are gonna sort of report all that out and communicate, to in some way trying to quantify or give greater detail on some of these new products, since it seems to me they're so critical in terms of just the overall thesis here?

Cheryl Blanchard (President and CEO)

Yeah, I appreciate the question. I mean, our business is still small enough that we're obviously reporting the way we are just to make sure that we provide valuable information that will trend. As we continue to grow and as we see a lot of these products making contributions that we think are worthwhile reporting out, then we'll definitely consider that going forward, Mike.

Mike Petusky (Managing Director and Senior Research Analyst)

All right. Very good. Thanks, guys.

Cheryl Blanchard (President and CEO)

You're welcome. Thank you.

Thank you.

Operator (participant)

Ladies and gentlemen, this concludes today's question and answer session and today's conference call. We thank you all for attending today's presentation. You may now disconnect your lines and have a wonderful evening.