Artivion - Q3 2024
November 7, 2024
Transcript
Operator (participant)
As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Lane Morgan from Gilmartin Group. Please go ahead.
Laine Morgan (Head of Investor Relations)
Thanks, operator. Good afternoon, and thank you for joining the call today. Joining me today from our top echelon management team are Pat Mackin, CEO, and Lance Berry, CFO. Before we begin, I'd like to make the following statements to comply with the safe harbor requirements of the Private Securities Litigation Reform Act of 1995. Comments made on this call that look forward in time, involve risks and
uncertainties, and are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The forward-looking statements include statements made as to the company's or management's intentions, hopes, beliefs, expectations, or predictions of the future. These forward-looking statements are subject to a number of risks, uncertainties, estimates, and assumptions that may cause actual results to differ materially from these forward-looking statements.
Additional information concerning certain risks and uncertainties that may impact these forward-looking statements is contained from time to time in the Company's SEC filings and in the press release that was issued earlier today. You can also find a brief presentation with details highlighted on today's call on the Investor Relations section of the Artivion website. Now I'll turn it over to Artivion CEO Pat Mackin.
J. Patrick Mackin (CEO)
Hey thanks Lane and good afternoon everyone. I'm pleased to report continued strong financial performance through the Q3 as we delivered robust revenue growth and further improved operating leverage. We also made breakthrough progress on several key clinical and regulatory initiatives that have collectively given us greater conviction in our ability to execute our best-in-class
PMA-focused pipeline and deliver sustained double-digit revenue growth while growing EBITDA twice as fast as revenue. In the Q3 of 2024 we delivered constant currency revenue growth of 10% year over year representing $95.8 million in revenue and Adjusted EBITDA growth of 28% year over year compared to the Q3 of 2023. Let me first cover our Q3 financial performance before addressing the significant clinical and regulatory updates for the quarter.
From a financial perspective, our strong Q3 performance was enabled by continued growth across our product portfolio as well as continued benefit from regulatory approvals and commercial footprint expansion in key international markets, especially in Latin America and Asia Pacific. From a product category perspective, On-X revenues increased 15% year over year on a constant currency basis as we
continue to take market share globally with the only mechanical aortic valve that can be maintained at a low INR of 1.5-2.0 based on feedback from the field, our recent market share gains and the proven clinical benefits of the On-X aortic valve. We maintain our strong conviction that On-X is the best aortic valve in the market and will continue to take market share worldwide. BioGlue grew 14% on a constant currency basis compared to the same period last year.
This was the second straight quarter of double-digit constant currency revenue growth for BioGlue. We are pleased with the strong performance to date with BioGlue as we continue to grow this differentiated product globally. Also in Q3, our stent graft revenues grew 13% on a constant currency basis in the Q3 compared to the same period last year. Our stent graft portfolio remains a key component of our growth strategy and we are encouraged by our strong results which were driven by our differentiated
portfolio of products focused on the more complex segments of the stent graft market. Today, the products in our stent graft portfolio are primarily sold in Europe where we leverage our existing direct sales infrastructure to create significant cross selling opportunities across our unique aortic product offering. Our pipeline consists largely of bringing these proven products to the U.S. and Japan markets which represents a significant growth opportunity.
Lastly, tissue processing grew 2% year over year on a constant currency basis compared to Q3 of last year. This slightly lower than expected growth was driven by lower than anticipated donor allograft volumes in the Q3. While we do not report revenues on a product by product basis for context, tissue processing growth is driven primarily by our SynerGraft pulmonary valves which are used in the Ross procedure. For those unfamiliar with the Ross procedure, it's a double valve procedure in which a
patient's native pulmonary valve is used to replace the patient's defective aortic valve and then the patient's pulmonary valve is then replaced by the donor pulmonary allograft. Because of the success of this procedure, demand for our SynerGraft pulmonary valves significantly exceeds our supply and therefore our growth is dependent on donor allograft volumes which tend to fluctuate from quarter to quarter.
Still, tissue processing revenues have grown 11% year to date on a year over year constant currency basis. Importantly, our team has also initiated new measures to further improve donor yields beginning in Q4 and early into 2025, leaving us increasingly confident that our tissue business can be a mid single digit grower. Over the long term, however, you should expect to see some fluctuations in growth rates
quarter to quarter driven by underlying fluctuations in donation. From a geographic standpoint, we continue to see great results from our growth initiatives across Latin America and Asia Pacific primarily through new regulatory approvals and commercial footprint expansion. Latin America and Asia Pacific delivered constant currency revenue growth of 32% and 23% respectively, compared to the Q3 of last year.
We continue to anticipate strong revenue growth for both regions for the full year and over the coming years as we continue to leverage our industry leading product portfolio in those regions. I will now turn to our product pipeline and regulatory developments. We are excited to announce that we recently filed the first module of the PMA application for AMDS with the FDA. We continue to anticipate FDA PMA
approval for AMDS in Q4 of 2025, which as we've discussed, would open up a U.S. addressable market opportunity of approximately $150 million with no competitive alternatives. I'm also pleased to announce our recent regulatory approval from the National Medical Products Administration, also known as NMPA, to commercialize BioGlue in China. We estimate that approximately 12,000 patients in China each year have an acute Type A dissection, which could benefit from BioGlue each year.
There are some additional administrative steps that we have to take to gain reimbursement and to get access at the hospital level. These steps are expected to take nine to 12 months and therefore we expect to begin commercializing BioGlue in China in the second half of 2025. BioGlue has been a great product for patients for many years and we're excited to be able to bring this technology to another large market
in China. Now to discuss the two regulatory updates, I would like to now update you on our pipeline and recently released clinical data. First, in October Endospan completed enrollment in the U.S. IDE pivotal trial called TRIOMPH for its NEXUS Aortic Arch Stent Graft system. Assuming the trial endpoints are met, NEXUS remains on track for approval in the second half of 2026.
As a reminder, aortic arch disease with aneurysms or dissections who receive treatment have previously had little choice but before NEXUS but to undergo an open chest surgery which is an invasive operation associated with lengthy hospitalizations and prolonged recuperation. NEXUS is a highly differentiated technology that transforms a complex surgical aortic arch repair into a minimally invasive endovascular repair. Second, at EACTS in October we are very pleased to see our AMDS and E-vita Open NEO Technologies take center stage at the aortic focus. Late Breaking Science sessions at EACTS. Late.
Breaking 5-year data from our AMDS DARTS trial reported long-term clinical follow-up on the remaining 25 of 46 study participants with acute Type A dissections who are treated with appropriate aortic repair and AMDS. The results demonstrate 94% of patients were free from aortic reoperation compared to existing literature on hemiarch only outcomes which report freedom from late aortic arch reoperation as
low as 76%. Additionally, 95% of patients were free from aortic diameter growth above 5 mm at zones 2 and 4. This compares favorably to existing literature on hemiarch only outcomes which suggests the majority of patients have early aortic diameter growth in the proximal descending aorta. For context, significant growth of the aorta can lead to increased risk of rupture, dissection and reoperation.
Long-term results from DARTS trial show a large majority of patients experience stable or decreased total aortic diameter following the treatment with AMDS and thus are at decreased risk for further aortic dissection or reoperation as far out as five years post implantation, thus showing the durable effect of the therapy. Third, regarding AMDS, 30-day from the PERSEVERE trial showed a cerebral malperfusion
resolution of 90% of affected subjects in the AMDS implantation group. The results also indicate a stroke occurrence of 10.8% following AMDS implant which compares favorably to 20.9% for Hemiarch alone. Based on the five articles in literature, cerebral malperfusion often leading to stroke is a major complication for acute Type A aortic dissections. These positive results from PERSEVERE trial show that AMDS reduces malperfusion and the rate of stroke.
We're excited to see the continued positive results from both DARTS and PERSEVERE studies further reinforcing the significant clinical benefits and life-saving nature of AMDS. Lastly, at EACTS, 1-year data from the NEOS trial showed that the E-vita Open NEO is safe and effective in treating aortic arch pathologies. E-vita Open NEO is our current generation frozen elephant trunk that is sold internationally
and is the predecessor to our pipeline product called Arecibo LSA. Notably, the 161 patients treated with E-vita Open NEO experienced lower 1-year mortality and 1-year combined major adverse event rates compared to the current market-leading device. Given that we anticipate the Arecibo U.S. IDE trial will be in the range of 120 patients, these results give us greater confidence in the future success of that trial.
In summary, we're encouraged by our Q3 financial performance and thrilled with the progress this quarter on the regulatory and clinical fronts. Our strong financial, clinical and regulatory performance positions us well for the remainder of 24 and beyond. It increases the confidence we have in our ability to deliver sustainable double digit revenue growth while driving EBITDA margin expansion and growing EBITDA twice as fast as sales. With that, I'll now turn the call over to Lance.
D. Ashley Lee (CFO)
Thanks Pat and good afternoon everyone. Before I begin, I'd like to remind you to please refer to our press release published earlier today for information regarding our non-GAAP results, including a reconciliation of these results to our GAAP results. Additionally, all percentage changes discussed will be on a year over year basis and revenue growth rates will be in constant currency unless otherwise
noted. Total revenues were $95.8 million for the Q3 of 2024, up 10% constant currency compared to Q3 of 2023. Adjusted EBITDA increased approximately 28% from $13.9 million to $17.7 million in the Q3 of 2024. Adjusted EBITDA margin was 18.5% in the Q3 of 2024, a 270 basis point improvement over the prior year driven by a 220 basis point reduction in general administrative and marketing expense as a percentage of sales.
We continue to believe our sales and G and A infrastructure is very scalable and the significant leverage we produced in the first half of the year supports our belief. From a product line perspective, On-X revenues increased 15%, BioGlue revenues grew 14%, Stent Graft revenues grew 13% and Tissue Processing revenues grew 2% in the Q3 of 2024. Other revenue declined approximately
$561,000 and 17% in the Q3 of 2024. While relatively nominal to the business, the decline in Q3 was driven by the timing of PerClot orders from Baxter as they continue to manage down inventory levels. Though the underlying end user sales of PerClot are beginning to ramp up. We expect these inventory dynamics to continue through the balance of 2024. Excluding this impact, our underlying business grew 11% in the Q3 compared to Q3 of 2023.
On a regional basis, revenues in Latin America increased 32%, Asia Pacific increased 23%, EMEA increased 15% and North America increased 2%, all compared to the Q3 of 2023. As anticipated, gross margins were 64% in Q3 flat compared to the Q3 of 2023. General administrative and marketing expenses in the Q3 were $50 million compared to $51.1 million in
the Q3 of 2023. Non-GAAP general administrative and marketing expenses were $46.6 million in the Q3 compared to $44.7 million in the Q3 of 2023. R&D expenses for the Q3 were $6.6 million compared to $6.4 million in the Q3 of 2023. We still anticipate full year R&D spend as a percentage of sales to be relatively flat to prior year. Interest expense.
Net of interest income was $8 million as compared to $6.3 million in the prior year. Other income expense this quarter included foreign currency translation gains were approximately $2.4 million. Free cash flow was $7.8 million in the Q3 of 2024. Importantly, we continue to expect free cash flow to be positive for the full year 2024. As of September 30, 2024, we had approximately $56.2 million in
cash and $314 million in debt net of $6.3 million of unamortized loan origination costs. This is inclusive of the impact of our recently closed July amendment agreement with Endospan. I'd also like to add that our convertible debt moved to current on our balance sheet this quarter as expected. As we've discussed, our delayed draw term loan announced earlier this year provides us the flexibility to opportunistically settle the convert with cash or shares.
Assuming our stock price exceeds $23.46 at maturity in July 2025. We do not anticipate the need to raise additional capital to fund our debt obligations, our investments in our channels or our pipeline in the foreseeable future. Our net leverage at the end of Q3 was 3.9, down from 5.3 in prior years. At the midpoint of our EBITDA guidance range, we expect net leverage to be closer to 3.5 by the end of the
year and to continue to decrease in 2025. Now for our outlook for the remainder of 2024. We are continuing to expect constant currency growth of between 10%-12% for the full year 2024 compared to 2023, narrowing our range of reported revenues to $389-$396 million compared to our previously articulated range of $388-$396 million at current FX rates.
We expect FX to have a negligible impact on full year revenue growth rates as we look ahead. We have conviction in the ability of the overall business to grow low double digits year over year over the long term, driven by our portfolio of differentiated products and our best in class R&D pipeline. With our continued top line revenue growth and general expense management through Q3, we continue to
expect Adjusted EBITDA to be in the range of $69-$72 million for the full year 2024, representing a 28%-34% growth over 2023 and 280 basis points of adjusted EBITDA margin expansion at the midpoint of our ranges. As a reminder, we expect gross margins to remain at levels similar to 2023 and continue to expect to drive significant leverage from our global sales force and G&A infrastructure.
Additionally, R&D expense is expected to remain relatively flat as a percentage of sales. Lastly, I would like to discuss 2025. We will provide 2025 guidance in February during our Q4 earnings call, but I did want to provide you with some directional comments as you think about 2025. In general, we expect the same dynamics to be in place for the existing product portfolio in 2025 as there are in 2024. With the
exception that we will not have the 1/4 of significant SynerGraft pulmonary valve increase benefit in our tissue business in 2025, and that we had in 2024. We expect to continue to drive EBITDA margin expansion by leveraging sales and G&A expenses. With that, I will turn the call back to Pat for his closing comments.
J. Patrick Mackin (CEO)
Thanks, Lance. So, as you've heard throughout our comments, we're committed to shareholders that we will deliver double-digit revenue growth and two times that for EBITDA. You've also just heard about our strong execution of our R and D pipeline which gives us stronger confidence that we can deliver on these financial commitments going forward. More specifically, we have the following key regulatory
approval and three PMAs in our R and D pipeline that will help us to deliver on the continued revenue and EBITDA growth. First, BioGlue China regulatory approval. This opens up a major new market starting in the second half of 2025. Second, the AMDS PMA. We've just completed the one year follow up of the PERSEVERE trial and we just filed the first PMA module, both of which put us on track for a Q4 2025 PMA approval.
Third, the NEXUS PMA. Our partner Endospan completed enrollment in the NEXUS IDE trial called TRIOMPH, which puts the PMA on track for approval in the second half of 2026. Fourth, our SIBO LSA PMA presentation of the clinical data at EACTS from the NEOS clinical trial, that is our current generation frozen elephant trunk called NEO, was in 161 patients which showed clinical results that are better than
the commercially available device that's on the U.S. market today. Given that our U.S. IDE trial for our Arecibo LSA will enroll around 120 patients, the results of the NEOS trial gives us great confidence the Arecibo LSA trial will also be successful. Finally, I want to thank all of our employees around the globe for the continued dedication to our mission of being the leading partner to surgeons focused on aortic disease. With that, operator, please open the line for questions.
Operator (participant)
Thank you. At this time we will be conducting a question and answer session. If you would like to ask a question, please press star then 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star and then two if you would like to remove your question from the queue. Again, if you would like to ask a question, please press star and then one. Now the first question that we have comes from Daniel Stauder of Citizens JMP. Please go ahead.
Daniel Stauder (Analyst)
Yeah, great, thank you. I guess I'll just start off on the aortic stent graft business. So another strong quarter despite 3Q23 being a tougher comp. I just wanted to ask if you can give any more color on what specific products are performing well or if you could just give us any puts and takes on what's driving this business and is there any cross selling benefits or anything you're seeing in the market? Thank you.
J. Patrick Mackin (CEO)
Yes, I would say a couple things, and Lance, you can chime in as well. I mean when you look at, we don't break out the specific product segment detail. We've got a half a dozen products that cover the entire span of aorta. Pretty much every one of them is growing double digits and continues to do so. So we're very kind of confident in that business continuing to grow in the double digit range. We're seeing it in Europe, we're seeing it in Asia, we're seeing it in Latin America. So I mean, I think it's kind of more of the same because we've got such a differentiated portfolio and we're expanding globally at the same time.
Daniel Stauder (Analyst)
Great, thanks. And just one follow-up on On-X. So you noted some share gains internationally. I just wanted to get a sense of what extent are you seeing this and how should we think about this or where this could go in 2025 and are you seeing more traction just mostly because of the new data with the reduced bleeding? Just any puts and takes or any other additional commentary as we think about that. Thank you.
J. Patrick Mackin (CEO)
Yeah, so if you start at the kind of the globe, we've got about 30% market share globally. We are much stronger in the U.S. We're in the 55% range in the U.S. The share gains we're seeing are really across the globe. We continue to take share in the U.S. driven by the post-approval trial. And just as a refresher, we ran the original PMA trial for On-X low INR and it showed a 60% reduction in major bleeding. We've
ended a post-approval trial with five-year follow-up required by the FDA and 500 valves. We presented that in May showed an 87% reduction in major bleeding. Based on our market checks and research, we expect our market share in the U.S. to continue to go up and we've got even more upside opportunity internationally. So I think On-X continues, and as we've told investors, we think that's a double-digit growth product and it has been for the last six or seven years. So we're continuing to execute on what we said we would do.
Daniel Stauder (Analyst)
Great.Thank you very much.
Operator (participant)
Thank you. The next question we have comes from Suraj Kalia of Oppenheimer & Co. Please go ahead.
Suraj Kalia (Managing Director and Senior Analyst)
Hi Pat, Lance. Congrats on the quarter. Can you hear me all right?
J. Patrick Mackin (CEO)
Yeah, we can hear you fine.
Suraj Kalia (Managing Director and Senior Analyst)
Perfect. So, Pat, SynerGraft long-term mid-single-digit growth. I guess just a tangential question. Do you think there are some other ways in terms of alternative assets that can be complementary to growth rates? How do you all think? Or basically this is the way the Ross is done, this is the way SynerGraft does and the donation algorithm and that's the way we should start thinking about it.
J. Patrick Mackin (CEO)
Yeah, I think so. There's a couple things that are, I think super impressive about one, the Ross and two, the Ross with SynerGraft. We have 25 years of data on the Ross procedure with SynerGraft. So and it's phenomenal. The reason the procedure's taken off is because of that data. There's been a kind of a number of different papers that have been published recently that show if you get a Ross procedure that
you can actually match the, the survival and lifestyle of a patient who didn't have one. So the data is outstanding. You know, the challenge here is that we're just constrained by donation now. We are doing things, we're always working on continuous improvement. You know, last year, this past year we've worked on our yields on the, on the SynerGraft pulmonary valve which have been very impressive.
We've got more kind of tricks up our sleeve. We've got other things we're working on because we're always looking at stuff. So we'll continue to work at it. It's just I don't have the luxury of telling the factory to make more. So we literally sell everyone that comes out and we're working to make sure that we can meet the demands of the market to the best of our ability.
Suraj Kalia (Managing Director and Senior Analyst)
Pat, in terms of, and I know this might be dumb, but the NEXUS trial, obviously the 30-day outcomes were good in terms of stroke and paraplegia and whatnot. Pat, even though the TRIOMPH trial calls out 30 days, remind us again, is there any late migration we should be worried about?
J. Patrick Mackin (CEO)
No. So we've had, I think, the only public data on NEXUS, the U.S. IDE trial called TRIOMPH, was presented at STS last year, I think in 20 patients. It was Brad Leshnower from Emory who presented that data and did show very good results. And you know, the big thing they're looking at right now is what's the stroke rate, what's the paraplegia rate, what's the REOP rate, what's the mortality? Renal dialysis. So
all the same stuff we track and PERSEVERE. So we have not seen the full 60-day cohort that will be presented to the FDA. We may see that in January, we may see that in May. We don't run that trial. Endospan runs that. So as soon as they get that data out, we'll be able to react to it.
I think the one thing that's very important about this device, and we went through this in our diligence when we looked at it, it is the only arch thoracic stent graft designed for the arch. And if you ask surgeons about it, it's specifically designed for the arch. It's a two-piece system. So to my knowledge, we've seen no migration on this technology because of that reason. It's a custom or specifically designed technology for the aortic arch and we've seen excellent results to date. And I'm very excited to see what the 60 show because I think this is going to be a game changer for patients.
Suraj Kalia (Managing Director and Senior Analyst)
Got it. Lance, one question for you and I'll hop back in the queue. Is the game plan still, if the stock is, let's say, above $30, force a conversion and then should we start factoring in on an as converted basis when we think about the fully diluted EPS? Because you guys are pretty close right now to break even and you just want to make sure from a modeling perspective, any color would be great. Gentlemen, thank you for taking my questions.
J. Patrick Mackin (CEO)
Thanks, Raj.
D. Ashley Lee (CFO)
Yeah, so we've continued to say we're in the, we have the luxury now of having options with our delayed draw term loan. And we've been saying for the past couple of quarters, look, we have the ability to take a wait and see approach to see what goes on with interest rates, what goes on our stock price and then based on that, decide we're still in that mode. What I would tell investors is it could go either way. And just to take whatever you think is the most conservative approach, if you want to put the shares in and assume that they get converted to shares. Is the most conservative approach.
Do that. If you want to assume that we draw down the delayed draw term loan and have incremental interest expense, if you think that's a more conservative approach, I would tell you to do that, and at the moment we're still watching and it could go either way.
Suraj Kalia (Managing Director and Senior Analyst)
Thank you.
Operator (participant)
Thank you. The next question we have comes from Frank Takkinen of Lake Street Capital. Please go ahead.
Frank Takkinen (Senior Research Analyst)
Great. Hey guys, Nelson Coxon for Frank and congrats on all the progress and maybe just want to start with AMDS. Can you walk us through how we should think about the launch of that? Maybe just the learning curve. You guys need to go through Vax. Is this a soft launch in 2025 with a full launch in 2026 and then maybe just some other. Any other comments would be helpful.
J. Patrick Mackin (CEO)
Yeah. Just to kind of refresh people where we are. Right. So I mentioned in my comments we just hit the one-year follow-up. We are going to have to obviously get that data pulled together and that will be the clinical module that gets submitted. Based on how we have laid out the modules we have submitted, our first module would put us in the, you know, an FDA approval has us on track for Q4 of 2025. So a year from now, I think you are, I mean assuming we get it in Q4 of 2025, I think a soft launch is a good way to describe Q4 of 2025.
We do have to go through value analysis committees, we do have to train surgeons, we've got to get them to buy the devices, so we've got a great sales force. We know these customers, we know these hospitals. We already have all the relationships but we still have to go through the process. I also think that the fact that this is a life-saving. I just told you that we saw strokes cut in half with acute A dissection
that was just published at EACTS from the PERSEVERE trial. I think the fact that the mortality is so much lower, the stroke is so much lower, pain is so much lower that we're hopeful that we can get through these value analysis committees faster, but I'll know it when we do it. I'll have better visibility once we've launched it, so. But we are geared up and we'll have the sales team ready to go.
D. Ashley Lee (CFO)
And maybe I'll jump in, just put my plug in for everyone. As you think about 2025, from a modeling standpoint, I would advise everyone to not put any revenue in for AMDS with the Q4 approval. And just the things you have to do to get going, revenue would be very minimal, if any, in 2025. I think the same thing is just at the moment to assume zero. And then if we get beneficial timing and it's sooner, then we can talk about adding some then.
Frank Takkinen (Senior Research Analyst)
Perfect. Thanks for that. Maybe just about the pricing.Opportunity in the preservation business, specifically SynerGraft, do you see more room to take Additional price or do you kind of? Feel like you're reaching a point where.
J. Patrick Mackin (CEO)
You can maybe stay consistent for a while? Yes, I mean, I think we're sensitive to the pricing environments out there and I think the price increase we did last year was pretty significant. And I don't think there's a lot of room on that. I think there's other parts. It's not the only tissue we have in the portfolio. So there are other areas where we will be getting price increases. But I think the SynerGraft one is probably not one we're going to be going after anytime soon.
Frank Takkinen (Senior Research Analyst)
Got it. Perfect. Thanks, guys.
Operator (participant)
Thank you. Ladies and gentlemen, just a reminder, if you would like to ask a question, please press star and then one. Now, the next question we have comes from Mike Matson of Needham & Company. Please go ahead.
Mike Matson (Senior Equity Research Analyst and Managing Director)
Yeah, thanks for taking my questions. I guess with AMDS, I'm a little. Surprised that it's the first module because I feel like the data is usually like the final module. So, can you maybe just talk about what?
J. Patrick Mackin (CEO)
Oh, yeah, yeah. No, no, let me clarify, Mike. I think it might have made it sound confusing when I just said that. Right. So we have four or five modules we're going to submit. We submitted the first module. The last module will be clinical. Okay, so you're correct. The last module is going to be closed.
Mike Matson (Senior Equity Research Analyst and Managing Director)
And so when would that. Final module be submitted, do you think?
J. Patrick Mackin (CEO)
Probably in the Q2,
Mike Matson (Senior Equity Research Analyst and Managing Director)
Q2 of next year?
J. Patrick Mackin (CEO)
2024, 2025. Yeah.
Mike Matson (Senior Equity Research Analyst and Managing Director)
Okay. You still think it can be approved in the Q4?
J. Patrick Mackin (CEO)
Yeah, I do. Okay.
Mike Matson (Senior Equity Research Analyst and Managing Director)
All right. Okay. And then just on BioGlue in China. I seem to remember you talking about that being like a $20 million opportunity. Is that still the right number?
J. Patrick Mackin (CEO)
Yeah, no, it's actually. Go ahead and
Mike Matson (Senior Equity Research Analyst and Managing Director)
then how. I'll let you answer that. Let me just go ahead and finish the question. So that, how fast does that, would that ramp? I mean, is this kind of like a one year step up or would it be like a more gradual kind. Of like tailwind over several years as you penetrate that market?
J. Patrick Mackin (CEO)
Yeah. So first thing is we, Lance and I, had to go back and look at our earnings transcripts and find out what we last talked about. BioGlue China, it was two years ago and we basically said we're working with the Chinese regulators and you'll hear from us in the summer 2024. And you know, we obviously are very happy to report on the approval. Your math is correct, but I think it's like most things. Right. So we
mentioned in my comments that we've, you know, China has its own special requirements, right. So we've got to get the national medical registration, then we have to get province registration and we've got to get on hospital price list. So, you know, it takes some time. So we aren't really expecting anything meaningful until 2H25.
But this will be, you know, we'll be rolling this out to hospitals, we've got to train surgeons, we've got to get them familiar with the product. So this will be kind of the gradual kind of uptick over several years, not a one-year thing.
Mike Matson (Senior Equity Research Analyst and Managing Director)
Yeah, okay, got it. All right. And then the PerClot manufacturing agreement. How much revenue is that generating and when does that end? When will that, to what degree will? That becomes a headwind at some point. What year would that be when that happens?
D. Ashley Lee (CFO)
So that depends on how fast they can be ready to take it over. They obviously would like to take it over as fast as they can and we'd be more than happy to transfer it to them. If it just went away completing. If it's a full year in and.
Then, a full year out, you're talking about three, slightly less than a one percentage point headwind. So it's just not significant this year. It's created some noise quarter to quarter, but it's always about a point. So for the full year this year it's probably about a point headwind to last year. And if it stays at that level, which is our assumption when it goes away completely, it'll be about a point headwind that year. Right now it looks like probably for sure we'll have it for the full year of 2025, and then we'll have to assess after that.
Mike Matson (Senior Equity Research Analyst and Managing Director)
Okay, got also has really little to.
D. Ashley Lee (CFO)
No impact on EBITDA. We're just kind of manufacturing it for them.
Mike Matson (Senior Equity Research Analyst and Managing Director)
Yeah, got it.
J. Patrick Mackin (CEO)
Okay, thank you. Thanks, Mike.
Operator (participant)
Thank you. The next question we have comes from Jeffrey Cohen of Ladenburg Thalmann. Cohen, please go ahead.
Jeffrey Cohen (Senior Healthcare Analyst)
Good afternoon. Thanks for taking our questions. So I guess firstly, Lance, you had some commentary about the preservation business for 2025, and was that Q1 that you called out from the previous bolus of Q1 and SynerGraft and Q1 last year or Q1 this year as it would pertain to Q1 next year?
D. Ashley Lee (CFO)
So we took the big increase in price for SynerGraft in Q2 of 2023. So we had one quarter in 2024 of elevated growth rates from that price increase before we annualized that. So if you look back in Q1 of 2024, we had a very high growth rate for the tissue business. And that's the one thing I'm calling out. That really will be the one thing that's different. If you think about 2025 versus 2024, we will not have that one quarter of elevated growth rate in the tissue business.
Jeffrey Cohen (Senior Healthcare Analyst)
Yep, that was the $25.7 million increase from $26.3 million. Okay, I got that. That's clear to me. Could you talk a little bit about LATAM and APAC by specific countries, Japan as well as the balance. APAC specific countries and. Or LATAM specific countries.
J. Patrick Mackin (CEO)
Yeah, you know, we're not going to get into specific countries, Jeff. You know, I don't necessarily need to telegraph it to our competitors what we're doing. I will say that, you know, in Asia, when I started here, we had one person and now we've got 50. In Latin America we had none, and now we have 25. We're direct in Brazil. We've talked about before. We mostly run a distributor business in Latam. So we've gone direct in several countries in Asia, but I'm not going to get into the specifics of where we are now and where we're going later.
Jeffrey Cohen (Senior Healthcare Analyst)
Okay, got it. And then lastly, Lance, any further commentary on gross margins for Q4 and or for 25? Does it feel like mid-60s is kind of the right territory to think about?
J. Patrick Mackin (CEO)
Yeah, I think at the moment we. Just need to think about gross margins being relatively flat year to year and quarter to quarter. You may have some minor fluctuations just due to revenue mix in any given quarter. And then once down the line when we get approvals of these products in our pipeline and they come to the U.S. market, then we should be able to see some gross margin expansion through mix. But at the moment I would tell people to just kind of model gross margin is fairly flat year to year.
Jeffrey Cohen (Senior Healthcare Analyst)
Okay, perfect. That does it for us. Thanks for taking the questions.
J. Patrick Mackin (CEO)
Thanks, Jeff.
Operator (participant)
Ladies and gentlemen, we have reached the end of our question and answer session and I would like to turn the call back to Pat Mackin for closing remarks. Please go ahead. So.
J. Patrick Mackin (CEO)
Yeah, well, yeah, thanks for joining. We appreciate it. We had another strong quarter of double digit revenue growth and more than twice that on the bottom line at 28%. You heard about some really amazing performance on our pipeline. Regulatory approval in China, late breaking trials on AMDS at EACTS in Europe, the biggest cardiac meeting in Europe, the NEO trial presented at EACTS as well.
We've also got NEXUS has finished enrollment in their pivotal trial which puts them on track for 2026. And we just saw the NEOS trial in Europe in 161 patients, which is more than we're going to do in the US and we had very positive results that were better than the market, the only product in the US market from a competitive standpoint. So we're very confident that we can continue to grow this business double-digit top line and twice as fast on the bottom line. And thanks for joining and we'll look to see you at our next call.
Operator (participant)
Thank you, ladies and gentlemen. That concludes today's conference. Thank you for joining us. You may now disconnect your lines.