Good afternoon, and welcome to the CONMED Corporation 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, this event is being recorded. Before the conference call begins, let me remind you that during this call, management will be making comments and statements regarding its financial outlook and its plans and objectives, which represent forward-looking statements that involve risks and uncertainties as those terms are defined under the federal securities laws. Investors are cautioned that any such forward-looking statements are not guarantees of future events, performance, or results.
The company's actual results may differ materially from its current expectations. Please refer to the risks and other uncertainties disclosed under forward-looking information in today's press release, as well as the company's SEC filings for more details on the risks and uncertainties that may cause actual effects to differ materially. The company disclaims any obligation to update any forward-looking statements that may be discussed during this call, except as may be required by applicable law. You also hear management refer to non-GAAP adjusted measurements during this discussion. While these figures are not a substitute for GAAP measurements, management uses these figures to aid in monitoring the company's ongoing financial performance from quarter to quarter and year to year on a regular basis, and for benchmarking against other medical technology companies.
Adjusted net income and adjusted earnings per share measure the income of the company, excluding credits or charges that are considered by the company to be special or outside of its normal ongoing operations. These adjusting items are specified in the reconciliation supporting the company's earnings releases posted to the company's website. With these required announcements completed, I will now turn the call over to Curt Hartman, CONMED's Chair of the Board, President, and Chief Executive Officer, for opening remarks. Please go ahead.
Thank you, Gary. Good afternoon, and thank you for joining us on short notice for CONMED's announcement of the signing of a definitive agreement to acquire Biorez, Inc. With me on the call is Todd Garner, Executive Vice President and Chief Financial Officer. Today, we signed and expect to close in early August a definitive agreement to acquire New Haven, Connecticut-based Biorez for a $85 million upfront payment, with the potential for $165 million in additional payments based on revenue growth earn-outs over a four-year period. The surgical specialty of sports medicine revolves around the concept of mechanical repair of ligaments and tendons. Clinical literature indicates a high rate of revisions following both ACL and rotator cuff surgery associated with tears of the underlying tissue.
Based on our research and discussions with the surgical community, this is a source of continued frustration and suggests that the limits of mechanical repair are in sight for these procedures. Over the last several years, the concept of ligament and tendon healing has emerged as the next significant leap forward in sports medicine treatment. Today in the marketplace, there exists a small number of first-generation offerings that address this goal in targeted specialties. Based on the revision rates in the traditional procedures, the existing market adoption of the first generation technology, and strong input from the clinical community, we have a clear signal of the importance and need for continued innovation in the healing space. Biorez, Inc., under the leadership of Kevin Rocco, President, CEO, and Founder, has developed the BioBrace implant.
This platform technology offers an innovative bioinductive scaffold that we believe is a leap forward in the healing continuum. BioBrace is cleared by the FDA with an indication for the reinforcement of soft tissue where weakness exists in order to promote soft tissue healing. Unlike traditional implant materials that are either synthetic or biologic, BioBrace is a biocomposite of both. The proprietary biocomposite architecture features a highly porous collagen matrix reinforced with bioresorbable microfilaments. BioBrace reinforces, regenerates, and then resorbs. The biomechanical profile enables load sharing to reinforce ligament and tendon repair throughout the healing process, while biologic matrix acts as a scaffold to support tissue regeneration. BioBrace provides supplemental strength for approximately two years before naturally resorbing. The platform is currently being marketed for applications in rotator cuff repair and ACL repair.
Because of the nature of the platform, we believe there are other surgical applications to pursue in the years to come. Today, BioBrace is available in the U.S. market through a small direct sales channel. At this point, there are approximately 350 implantations ranging up to one year post-procedure with no reported revisions. I'm very encouraged by the potential of the technology. We believe that the mechanical repair market will embrace BioBrace because it serves as an augment to existing procedures rather than a disruption to a surgeon's technique. BioBrace will encourage more thorough healing, drive better outcomes for patients of ACL and rotator cuff repair. Biorez brings to CONMED a very credible and experienced leadership team and a game-changing product that is a second-generation innovation.
This offering will differentiate CONMED in the global sports medicine market, and importantly, will advance the science of soft tissue healing while helping to reduce the expensive revision rates in both the ACL and rotator cuff markets. From business standpoint, the CONMED global orthopedic sales and marketing channel is well-positioned to advance this technology and leverage the Biorez leadership team's immense technical expertise and market credibility. In the U.S. market, our existing sports medicine business will take on responsibility for the BioBrace commercial efforts. Outside of the U.S., the products, once regulatory approval is obtained, will be carried commercially by our orthopedics team. Finally, CONMED will bring a business platform to expand areas such as medical education, RA/QA, distribution, legal, and accounting, to name a few. This is a high-growth, high-margin business that supports our ongoing strategy and continues our portfolio mix towards more innovative offerings.
We expect to record approximately $1 million in revenue for the remainder of the year while noting that sales force training, customer education, clinical study focus, and instrumentation set development for the rotator cuff applications are the key priorities at this stage. With that said, we expect the transaction to be accretive to our top line and accretive to our gross margin while being dilutive to earnings in 2022 and 2023. CONMED has been evaluating strategic additions for our core sports medicine business for many years. This is an area of the market that has limited game-changing technologies. We think our patience and diligence has allowed us to find a truly differentiated and innovative offering supported by a highly talented team of employees.
We look forward to welcoming Kevin and the Biorez team to CONMED as we work with them to continue to accelerate the adoption of BioBrace. In closing, I'm pleased with our performance in the first half of the year, as well as the second quarter addition of the In2Bones business and today's acquisition announcement. These two recent transactions demonstrate our commitment to innovative solution for the market while also highlighting our patience and commitment to innovate and grow our business in all the markets we serve. I'll now turn the call over to Todd, who will provide a quick overview of the financial details of this transaction and take you through the updated guidance to reflect this addition. Todd?
Thank you, Curt. As usual, we have included an investor deck on our website that provides a brief summary of the acquisition and our related guidance updates. We will discuss expenses and profitability related to the transaction, excluding special item charges. As Curt said, we only expect about $1 million in revenue for the remainder of 2022 from this acquisition. Our short-term focus will be to gather the human clinical trial data and improve the associated instrumentation before we pursue a broader commercial launch. We will talk about the guidance for 2023 in January, but at this time, we expect $ single-digit millions of revenue from the acquisition in 2023 and $ double-digit millions from this platform beginning in 2024.
We expect the gross margins from this product to be above 80%, which continues our pattern of shifting the mix of the portfolio to faster growth and higher margins. Obviously, this acquisition will increase R&D, SG&A, and interest expense above our guidance levels we gave you last week. Our current variable interest rate is about 4%, and of course, that changes with each announcement from the Federal Reserve. We estimate that the impact on adjusted cash EPS will be $0.10-$0.15 of dilution in both 2022 and 2023. We expect this acquisition to be accretive beginning in 2024. This next point is unrelated to this acquisition, but I've heard some confusion after last week's earnings call about the treatment of the convertible notes going forward on adjusted EPS.
I gave you direction related to the new share count, but I also should have clarified that going forward, we will no longer need to add back any interest expense to the adjusted income number. There will be no add back going forward. Our updated adjusted EPS guidance range for the year is now $3.25-$3.45 to reflect the expected dilution from this acquisition. We've again provided a detail of the pieces of our updated guidance in the investor deck associated with this call. As it relates to Q3 financial guidance, as we said, the impact to revenue is expected to be negligible. We now expect the range of Q3 adjusted cash EPS to be between $0.71 and $0.79, reflecting $0.05-$0.07 of impact to Q3 alone from this acquisition.
The current macro environment poses unique challenges that are impacting the entire healthcare industry, including CONMED. However, we do not want to let these near-term macroeconomic headwinds dictate actions that could hamper our long-term growth and profitability. We could have stopped all future investment and focused only on protecting short-term profitability during this temporary storm. We believe we have found two very attractive platforms in In2Bones and Biorez that will contribute significantly to the strength of our orthopedics business in both revenue and profitability. We found these deals at very good prices and financial structures. It will take 18 months to achieve positive returns to the bottom line from these investments, but we're very excited about the additions to our portfolio. Both platforms bring double-digit revenue growth with gross margins over 80%, which exemplifies our approach of shifting our portfolio to faster-growing and higher-margin platforms.
I'll finish my comments today with the same sentiment I shared at the end of the Q2 earnings call last week.
We are clearly strengthening the long-term health of the business. In the short term, our business momentum remains strong. In Q2, we grew organic revenue by 9% against our strongest quarter of 2021, and we expect Q3 and Q4 to grow double digits. When the cost challenges subside, and they will at some point, we are excited about the profitability this improved growth and margin engine can provide. With that, we'd like to open the call to your questions, and I'll turn it back to Curt.
We will now begin the question-and-answer session. To ask a question, you may press star then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. Please limit your questions to one with a single follow-up. At this time, we will pause momentarily to assemble our roster. The first question is from David Saxon with Needham & Company. Please go ahead.
Hi. Good afternoon. Thanks for taking the questions and congrats on the deal. Maybe just wanted to ask a question about kind of the price tag and you know what you're assuming in terms of revenue. I mean, you know what you're paying, I feel like it kind of indicates that you think you can ramp this fairly quickly, but single digits in 2023, double in 2024. Maybe talk about just you know how conservative that is and also what it assumes in terms of you know applications outside of rotator cuff and ACL and then as well as international expansion. I have one follow-up.
Okay. There was plenty there, David. We'll try to get it all. I'll start and let Todd finish. Number one, we're super excited about the transaction, and the references I would point to are some of the first generation technologies that are in the marketplace today. One of those had been acquired by another large strategic a few years back. There's currently another one in the marketplace that is going through what I would call early stage growth phases. Everybody in the market is aware of those technologies and understands how they've progressed. The price that was paid for the first one is public domain information. We think there's some precedent transaction material out there that supports this price range.
Obviously, the most important thing supporting the price range would be our own expectations in the short and the long term. I wanna remind everybody, in the short term, our work is gonna be focused on four things. Education of our sales force, education of the customer base. That is right off the top of the list. The development of an instrumentation set for the shoulder application. We think that is needed. We think that'll be an important point of growing the shoulder application. Clinical studies. The company has great clinical data but does not have long-term patient follow-up. As I noted in my comment, there's over 350 implantations that stretch out to a year. Clinical studies are underway to validate the in-body, in-person experience clinically and use that to drive the results.
We feel that should be a very favorable outcome, and that's where we think the real inflection point on the revenue growth will come into play. It fits in very well with our existing sales channel call point. It's already available in the knee and shoulder. That's where Biorez, Inc. had been marketing the product. Outside the U.S., it is purely predicated on the clinical study submissions in markets that require clinical studies and getting the EU MDR-type applications through the process, and those just vary in time around the globe. Our models and our development did not assume anything relative to international development, did not assume anything relative to other applications. We based our models and our beliefs on what we had in front of us.
I'm gonna let Todd take a stab at the remainder of those questions. You might have to remind us what we missed there.
I think that covers most of it, David. I would just tell you that our model provides returns we think are very healthy returns. You know, double-digit IRR kind of returns. Obviously, this is a little different than our previous three acquisitions, which came with more existing revenue, so a little easier to do those multiples. We feel very good about the price paid, but even better about the structure, right? The team at Biorez is sticking with us, and they are incented over the next four years to maximize the performance of this platform for them to realize the full value here. We think it's a good deal at a good price and a great structure, and we're excited about it.
Great. Yeah, that's super helpful. Then, you know, I'm sure the investment community is gonna reach out to docs and try to get some checks. So maybe give us a preview, what would you hear in your deal diligence, you know, with regards to physician feedback? Thanks so much for entertaining the questions.
Yeah. Again, Biorez was in the early stages of commercial development, and that's reflected by the sum total of 350 implantations. Our commercial channel checks were highly supportive, and we did both direct channel checks as well as blinded channel checks. The value that CONMED brings here is the size of our sales force and our ability to touch a lot of customers. We've known this company for a while. They're active participants at the same trade shows we go to. We've talked to the management team for a period of time now. We feel very good about the breadth of diligence and marketplace knowledge that we've been able to gather.
Great. Thank you.
The next question is from Matthew O'Brien with Piper Sandler. Please go ahead.
Afternoon. Thanks for taking my questions. For starters, Curt, you know, talk about the competitive landscape. I mean, it looks like Arthrex has a product here. Smith & Nephew is obviously buying Rotation Medical for a lot of money. Both of those companies are really strong in sports medicine. You know, just the comfort level that you have that you can compete effectively against those two with this product, and what kind of pull-through sales can you get from it, et cetera, you know, as you're integrating this 1+ In2Bones?
I think both of those companies we compete with today already, and we do that both in the U.S. and outside the U.S. Not a new competitor. Relative to the product in the marketplace, we feel this is a second-generation product that is advantageous relative to anything else that exists, and that's because of the nature of the product. The matrix that is created through the fiber weave is proprietary, and we think that brings a real advantage here, and that's why we continue to refer to it as a second-generation product. You know, our strongest market is the shoulder. We've got growing product portfolio in the knee. Longer term, we would not be surprised to see customers who are interested in BioBrace start adopting and using other CONMED products.
There is an element of pull-through that can exist. Again, as I said, we're gonna move slowly and cautiously here to make sure we do the clinical study follow-up correctly, that we make sure medical education, both of CONMED staff as well as the clinical community, is appropriate for a product of this what I would call advanced state of technology in the marketplace.
Okay. Then the follow-up's got a couple parts to it, and maybe three. But can you just talk about how competitive the process was for this asset? Did you have some even larger strategics looking at it? What's the timing as far as that extra $165 million? And then Todd, what's the leverage ratio post the initial lump sum, and then with the earn-out? Thanks.
Yeah. Let me start with the middle. It's a four-year potential earn-out, and that four-year potential starts one year after the anniversary date of the first full quarter. Hopefully, that all makes sense. It's very similar, candidly, to what we did on the In2Bones transaction. The process, I'm not gonna get into the mechanics of the process here on the Biorez acquisition. We did our best to put our very best foot forward from day one, and as a result, we're able to hold this call today. I'm very proud of our team and the work they did.
As I said, we've known of this company and its leadership team for over a year now and have spent a lot of time in that relationship to get them comfortable with CONMED as the right platform for their future of a highly innovative product.
Matt, as far as leverage goes, we ended Q2 4.7 turns. This is obviously $85 million up front. Everybody has their own different model for EBITDA, but, you know, this puts us in the low fives, which is a comfortable place to be.
Thank you.
The next question is from Matthew Mishan with KeyBank. Please go ahead.
Afternoon and congratulations on another deal.
Thanks.
Just first, what does their clinical data, like, indicate? You know, what are the key findings from that data?
Which I'm sure everybody will do on the clinical study or on the post-call follow-up, you'll go on their website and look. What you're looking for with a collagen-based product in a matrix such as this is tissue ingrowth. You get tissue thickness, you get tissue healing, and the FDA approval is for tissue healing. What you're trying to do is ligament and tendon tissue repair. As those things tear, you want that material to come back together post-surgery. This is an augment to the procedure that helps the regrowth. What they have right now is animal study data. Obviously, you have to go into the market, do long-term patient study data, and the patient study data is what we're gathering at this point in time.
The tissue growth, the tissue thickness, the healing of tissue, those are all types of things you may be looking for in a clinical study. I'm not gonna get into the mechanics of the individual clinical studies that are in the marketplace. Suffice it to say that is a big area of focus for us post-close of the transaction.
Okay. You know, I think one of the areas of strength that I've always found from CONMED Ortho is you are very strong in, like, fixation-type devices, so this is a market you know well. Is this something that really complements your existing portfolio, or is it replacing anything?
Like in your portfolio.
Oh, this is a total complement. This is on top of and second generation. You know, I think one of the benefits of the In2Bones acquisition was them bringing a full sales team that focused on lower extremities. CONMED Orthopedics sports medicine business had some extremity products. The In2Bones acquisition helped clarify the sports medicine channel for us a little more, and now we're putting a product into that portfolio that is right in the center of what they do day in and day out, whether they're calling on the knee or the shoulder sports medicine doctor. This does not replace or diminish the value of any of the mechanical items we have, and it's an augment to all of those, but it's a second generation augment.
Very excited by the technology, what it brings and how it will enhance the overall value of the existing portfolio. Matt, I would just add back to your previous question the preclinical data that is available now. We put a summary slide in the investor deck that will help you with that.
Thanks, Todd.
The next question is from Robbie Marcus with JP Morgan. Please go ahead.
Oh, great. Thanks for taking the questions and, congrats on the deal. Todd, you talked about leverage now at around 5x. You know, how should we think about your appetite at this level for future deals? Is the focus gonna be on digesting these two? And at what point do you think you could look again for more deals?
Yeah, I mean, we've said from the start that the primary use of cash has always been to add platforms to the portfolio that improve our revenue and profitability growth. That doesn't change. It obviously, the filter, you know, gets a little tighter, right? We have to make sure that we get the returns on our prior investments and feel comfortable with those, as we look at new opportunities. We'll continue to look at opportunities. We also, you'll see announced today, with a 8-K filing that we did, work with our banks to provide a little more room in our leverage covenants.
You'll see that we have plenty of room in the low fives to go forward and operate the company and continue to keep our eyes and ears open for other opportunities that may be as attractive as we believe this one is.
Gentlemen, it appears Mr. Marcus disconnected before he heard your answer. We'll bring him back on if he could reconnect, but we'll move on to the next question with Rick Wise with Stifel. Please go ahead.
Good afternoon to you both. Maybe talk a little bit if you would, Curt, about a couple of things. One, maybe I missed it, but your view of the current and maybe future TAM, how you're thinking about it. I'll just ask all at once. Second, supply just as the growth acceleration you're dreaming of, just on the supply manufacturing side and, you know, I'll leave it there. Thank you.
Sure. Thanks, Rick. You know, the TAM question is a great question, and there's a couple different ways you get at it. Again, today, I'm gonna focus this on the knee and the shoulder, which is where they have started their marketing and commercial sales efforts and where we will continue. You can look at revision rates in those spaces. You can look at just the overall size of the respective shoulder and knee mechanical aspects and where this service is augmentation. The reason I'm bringing all this up, there's a lot of different ways. The third part is we're building a new market as well, which there's a couple precedent technologies in the marketplace that have started that process.
When I put all that together and our marketing teams and our leadership team sit around the table and talk about total addressable market, in the knee and the shoulder right now, we would call it a $2 billion total addressable market. What could that future be? Obviously larger. I say that not to be cute, but simply to say you look at applications for this and call it foot and ankle or other areas of tissue healing. It's just gonna get a lot bigger. We have not put in the work yet there. Our efforts here were principally focused on looking at the knee and the shoulder. On the supply side, obviously a great question in today's environment.
The ability to ramp up our sales effort, is dependent on our ability to ramp up the supply effort. We spent a fair amount of diligence in that. One of the beauties of this is the manufacturing process and the manufacturing partner that Biorez had found through their own work to get the product into market. It's a great story that the founder tells about finding the manufacturing partner. We think it's a very scalable manufacturing partner, or very scalable manufacturing process with a very, very credible manufacturing partner. Oddly enough, they also happen to do some work with us now through the In2Bones acquisition. It's a bigger partner for CONMED, literally in the last 45 days.
All right. Exciting good stuff. Thank you very much.
Thanks, Rick.
The next question is a follow-up from Matthew O'Brien with Piper Sandler. Please go ahead.
Great. Thanks for taking the follow-up. Just based on what you told Rick just now, I'm, you know, looking on YouTube and getting some numbers from the company, you know, we see like 700,000 cases between ACL and rotator cuff a year, and I don't know if that number is bigger. You know, that's like $2,000-$2,800 for per implant. I'm just curious if that's kind of the number we should expect as far as ASP goes. Then, you know, within sports medicine cases, is there enough reimbursement in place to support that level of implant cost? Thank you.
The answer to your first question is you are absolutely in the ballpark, Matt. The knee and the shoulder price points are a little bit different, but in general, it's gonna be right up in that $2000 range. As far as reimbursement goes, we feel very comfortable with reimbursement that's available in the market.
Okay, sorry, just to follow up, Curt, but just from a economics perspective to the centers in terms of like, you know, what they get out of putting this, I mean, it makes a ton of sense given some of the recurrence rates, but there's enough on the economic side to make this a, you know, even when you include the extra cost here, a highly profitable procedure?
Yes.
Okay. Thank you.
This concludes our question- and- answer session. I would like to turn the conference back over to Curt Hartman for any closing remarks.
Thank you, Gary, and thank you, everybody, for carving out time on what we know is a very busy week to join us today. We look forward to speaking with you again in the future, which will be on our next earnings call. Thank you.
The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.