Okay, great. Thanks for joining us here for our next session. I'm Matt Taylor, the Jefferies Medical Supplies and Devices analyst. I'm joined here by members of the Teleflex leadership team, including Liam Kelly, the CEO, and Larry Keusch, who directs IR and strategy for Teleflex. These kind of meetings, I like to start a little bit high level. Maybe you could talk about Teleflex's positioning in the healthcare market. I also want to go through some of your portfolio management because you're making some big decisions here between RemainCo and NewCo and made some new disclosures about maybe leaning more towards the sale of NewCo. Maybe talk about why you're doing that and give us an update on where that is.
Yes, absolutely. Just to take a step back, why did we decide to separate the company? The board and management believed that RemainCo and NewCo had two different growth profiles, two different opportunities for investment, two different processes for capital allocation. As such, in our Q4 earnings call, we announced the separation of Teleflex into two companies, NewCo and RemainCo. We did that in our Q4 earnings call in February. A lot has happened since February. We knew at the time that by saying that we were going to separate through a spin public company offering, we anticipated we would get inbound interest in the assets. What we did not anticipate was the amount of inbound interest we were going to get in the assets. We got a lot of inbound interest.
I think, candidly, it speaks to the quality of the assets that were put up for the separation through a spin. On the Q2 earnings call, we again updated the investment community to advise them that we had indeed had a lot of inbound interest. At that stage, we had held some high-level management meetings with some of the interested parties. We advised that we were going to go on a parallel path, a separation through a spin and a separation through a sale. Between the Q2 earnings call and our Q3 earnings call a couple of weeks ago, we had done a Herculean amount of work in engaging with these interested parties.
On the Q3 earnings call, we announced that we, given where the momentum we had built in that time and given where we were in the process, that we were indeed prioritizing a sale of the company. We had, and we also announced that we were at the advanced stages of the due diligence. We still see a spin as an opportunity to create shareholder value in the event that that is required. Of course, our goal is always to maximize shareholder value. We have run all the analysis on the tax breakage. We have run all the analysis on what this company would be worth on the public markets. We believe that a separation through a sale would be in the best interest of our shareholders. The board and management continue to engage with these parties.
We will keep the investment community updated as we make progress through this. Regarding the timing, we said the separation through a spin would be halfway through 2026. Obviously, if you did consummate a sale, given where we are in the process, you'd envision that that would be sooner than that time frame. We feel comfortable where we're at. We think there's a—we've a lot of work done. We've worked incredibly hard to get to where we are right now. We believe this is in the best interest of our shareholders.
Maybe let's move on to talking about more on the RemainCo side and the assets that you have. Talk about why they belong together and now the addition of BIOTRONIK. What does that add to the portfolio?
Yeah, first of all, it'll really simplify our business. I'll just give you a couple of examples. In Teleflex today, we have seven business units and we have 19 manufacturing sites that we run and manage every single day. In RemainCo, we will have three global business units and we will have seven manufacturing sites that we will be managing. It simplifies our business. Strategically, if you think about a patient flow through the hospital and you think about how a patient enters the hospital, they normally are brought—they either walk or they're brought by an ambulance into the emergency room. Within our vascular and emergency medicine business, we will have a full suite of emergency medicine products for that patient. Normally, the patient will get one of our EZ-IO products. If they've had bleeding, then one of our hemostatic products will get used.
They'll get into the emergency room. Then they'll get triaged within the emergency room where potentially one of our PICCs will get used on the patient. They go to—normally, they go to three—they either get triaged out or they go to three areas in the hospital. They'll either go to the intensive care unit where our vascular portfolio is available for that patient. They'll go to a surgical suite where our surgical portfolio is available for that patient. Or they'll go to the cath lab where our interventional portfolio is waiting for that patient. Strategically, we're positioning Teleflex as an acute care, emergent, non-postponable procedure company firmly wedded within the hospital setting.
If we look at the performance of RemainCo through the first nine months of this year, and if you exclude the impact of volume-based procurement and you exclude BIOTRONIK—and the reason I'm excluding the volume-based procurement is because it's transitory—it'll be pretty much washed through by 2025. In 2026, we won't have a secondary impact of that. If you look at the performance through the first nine months of the year, the business is growing at approximately 5%. Firmly rooted in the mid-single digits where we want to be able to grow consistently with this business. If you look at BIOTRONIK coming into that mix and you look at BIOTRONIK, we've owned that now for four months. We've had one quarter of results tucked under our belt. On an as-reported basis, that business grew approximately 7% in the first year of ownership.
I'll spend a few minutes on BIOTRONIK as part of your question as to how that fits together within Teleflex. If anybody didn't have the opportunity to listen to the webcast last Friday, I would encourage you to go and listen to it. We had some docs talking and we were outlining why this business fits so well into Teleflex. Again, taking a step back and looking at this strategically, we are going to be focused on complex PCI. There's a niche within this market where we can bring a level of expertise and we can carve out a space for ourselves there without having to compete with the bigger players who are really focused on general PCI and other areas of the cath lab.
If you look at the BIOTRONIK VI business geographically, 50% of the business is in Europe, 25% roughly in the States, and 25% in Asia. If you look at our business, it's the polar opposite, concentrated in the United States. We are putting these sales forces together and we will have a much larger sales force in Europe, Asia, and in the United States selling this combined bag of products. This combined bag of products fits very well together, specifically in complex PCI. Our sales organization globally is every day in the cath lab with complex PCI, with our access catheters, the GuideLiner, the TrapLiner, or the Turnpike. These are used to gain access to the tortuous arteries. The BIOTRONIK VI drug-eluting stent is the most malleable stent when you want to put it in, and it's also tapered.
When you get to these tortuous arteries in complex PCI, it is the best stent. There is loads of clinical data to show on head-to-head comparisons, it is better than the comparable stents on the market. You add that to the other range of the portfolio, the balloons. I think what the feedback we got immediately following the call was, "Oh, we were a bit surprised the pipeline is pretty robust for this company." Also, the existing portfolio is much broader than we would have thought. This is not just a drug-eluting stent company. There is a lot more to this company than meets the eye. Combining these two together, and the fact is that, especially in the United States, we can gain access to the cath lab for complex PCI, whereas it is more difficult for a smaller company like the BIOTRONIK VI business.
That will gain us access there. That market's growing mid-single digits. That's an attractive market. Their peripheral products will also bring us into faster growing, higher single, low double-digit growing markets and give us an opportunity to grow into that space. As we outlined on the call, we have the optionality of Freesolve. What is Freesolve? Freesolve is a scaffold that really falls into the trend today in interventional cardiology of leave nothing or leave less behind. Again, for a cohort of patients, and particularly those with longer lesions, STEMI patients, patients that are younger. If I have a coronary event today and I'm 59 years of age, the likelihood of me having another event before I'm 70 is very, very high.
If you put a drug-eluting stent in, then you have burnt a bridge for the future treatment of me. You can't put a stent on top of a stent. You could use a balloon. There are balloons out there in the marketplace today. They also have their limitations. I like the optionality of Freesolve. What it is, it's a scaffold. It's made of magnesium, a drug-eluting scaffold that operates like a stent with the big caveat. It gets absorbed into the body after 12 months. There have been previous technologies that tried to do this, but they didn't absorb for four years. They were polymer-based. When you tried to position them in the artery and you tried to extend them, they cracked. Over time, they cracked and pieces were left.
Whereas this product, we believe, has been largely de-risked by the first study, BIOMAG-I, which showed it was opened up the artery and was fully absorbed after 12 months. We are doing BIOMAG-II in Europe. That study should have a readout at the end of 2027. We are kicking off BIOMAG-III for the United States because we like the optionality of this product into the future. There is a lot there, Matt, but I'll pause.
No, great. No, I actually wanted to double-click on BIOTRONIK after you made some of the statements. I think before you have really characterized this as likely growing kind of at the upper end of mid-single digits for that piece of the portfolio. With the geographic synergies, some of the portfolio synergies, why could not that part of the business grow faster?
I think it has the potential to grow faster as we bring in new technologies to the market. One thing that we are focused on with RemainCo, and if you think about RemainCo, good solid mid-single digit growth, gross margins better than what Teleflex has today, operating margins similar because we're going to invest more in R&D. Our goal is today Teleflex spends around 5% in R&D. For RemainCo, we're actually going to spend more than that, and in particular in the interventional space because that's an opportunity to bring new technologies to the market. In time, I think the interventional portfolio will be able to grow at that higher level. Even firmly in that mid-single digit range, our thought is that interventional will grow at the upper end and even beyond that.
Surgical will grow in that area, and vascular will be a little bit on the lower side, especially in the earlier couple of years as we build momentum. There is the potential for the interventional portfolio to continue to aggregate that growth with new product introductions and new technologies coming to the market and expanding the market, as you rightly said. There are opportunities for Go Direct in different geographies that will augment that as well. We feel that the combination of our interventional business and the BIOTRONIK VI business will facilitate that.
A couple of other follow-ups there. One is for Freesolve. You talked about some of the interplay with drug-coated balloons. I was wondering how you think the world might evolve in terms of clinical segmentation there between balloons and that kind of a stent solution.
Drug-coated balloons have been available in Europe for many years. What you see in Europe is that while the pricing of drug-eluting stents has come down, their use in volume has remained stable to growing. Everything is used in combination as we're doing more procedures. Why is that? There is more diagnosis of the condition. The condition is also growing. It's becoming more prevalent because, unfortunately, as human beings, fortunately, we're living longer. Unfortunately, we're not taking great care of ourselves as we live longer. I think that you do see a higher prevalence and a higher diagnosis of the conditions which keep the market growing. Things are used in combination. Just because you use a drug-eluting balloon does not mean one of the side arms that you're not going to put in a scaffold or a stent.
I think that products are used in combination. I think that as the clinicians outlined on that call, as you inflate the balloon, you are sometimes doing some damage on the walls of the arteries as well that you need to combat. Not everything—there is no utopia. In some patients, you'll use stents. In some, you'll use balloons. In some, you'll use scaffolds. In some, you'll use a combination of all three in order to get to the right diagnosis. It depends on the length of the lesion. It depends on the calcification. It depends on the patient profile. For sure, this market is going to continue to grow and expand in all areas with these technologies.
I guess you mentioned the pipeline for BIOTRONIK. Outside of Freesolve, what are some of the other products that you're most excited about?
There is a number of products that we are expanding in the balloon area, in the coated balloons. There are also different lengths of stents in order to manage those larger lesions. There are products that we cannot disclose and could not disclose on the call for competitive reasons that are in the pipeline and being worked on that we have a level of excitement about. As we get closer, we will give the investment community some additional knowledge and insight into those.
Gotcha. You touched on this, but could you talk a little bit more about the margin profile of RemainCo? You mentioned a little bit higher gross margin and R&D spending. I guess with SG&A, where does that net out? Should we think about any stranded or stand-up costs in the different scenarios that you have?
Yeah. So in our thought that the gross margin will be obviously, we expect it to be better than Teleflex, the op margin similar to Teleflex. There is some stranded cost already contemplated within that. There is also the additional investment into R&D contemplated within that. Now, obviously, if we're able to consummate a sale, some of the stranded costs are offset by MSAs and in particular TSAs, transitional service agreements as you move forward. Those costs will then come out later in the pipeline. There is definitely an option for both gross and operating margin expansion even beyond the initial launch of Teleflex RemainCo because of that dynamic that's going to occur as you work through the process with the acquirer in the same way as it happened with our respiratory business when we sold that. There was 18 months where we had MSAs in place.
That should be somewhat of an offset to the stranded cost right out of the gate that we should see materialize in the future. Obviously, we'll be diligent in looking at RemainCo to make sure it's as efficient as is humanly possible.
Maybe just touch on tariffs related to margins as well. I think you've had a $0.50 or so headwind now this year. Can you talk about how that plays into next year and what you're doing to help mitigate that?
Yeah, absolutely. We began the year with a $55 million impact on tariffs, a buck five of a negative impact right out of the gate. That was at our Q4 earnings call. When we got to Q2, obviously, there had been some changes, the biggest change being in China. You're correct. Now it reduced from $5 to around a $50 cent headwind on tariffs, $25 million-$26 million. What changed was, as I said, the biggest change was in China tariffs. Also, we did a lot of work ourselves on bringing more of our product to be USMCA compliant. We began at the beginning of the year with around 50% of our portfolio that moves from Mexico to the United States being USMCA. Right now, we're around 70%.
We're never going to get to 100%, I don't believe, but we can continue to improve on that. We're still doing work on that. Hopefully, we'll have progress made there by the time we get to give guidance for the full year. I think that we did move inventory into certain geographies ahead of tariffs. For 2026, it's not a question of just taking the $26 million and multiplying it by two. There will be some ancillary tariffs on top of that because of the timing of some of these tariffs. We are working to offset them with USMCA, with pricing, with some other strategies around Nairobi. We'll give more details when we get to give guidance in February on exactly what the tariff impact will be.
Gotcha. Before, you also mentioned that you're going to be through a lot of the China VBP by the end of this year. Are there other categories that have not been addressed by that that could be at risk in the future for pricing pressure?
Yeah, almost all of our portfolio in China has been through volume-based procurement. You even saw it in the performance of China. The low point for China from a revenue growth was in Q1. It was still negative in Q2, but got a little bit better, got better in Q3, and will continue to get a little bit better in Q4. Specific to RemainCo, our vascular business has been through, our surgical business has been through, and our interventional business has been through, with the exception of balloon pumps because there is no competitor for balloon pumps. There is one just launching, but it will take them five to 10 years to get any type of volume before it would be viable to be part of volume-based procurement.
What we have seen actually ourselves as we gain more experience with volume-based procurement, we have gotten better at capturing the volume through the process. Also, some of the earlier VBP's that were done, when they came back the second time around, I think that there was a realization they might have gone a little bit too deep, and it did hurt domestic companies. We have seen, and we have not been through a second round yet, but the companies that have, they have seen their prices come up a little bit from the lows of the first round.
I guess maybe just also thinking about the future for RemainCo, can you talk about the capital allocation strategy as kind of the dust settles either way?
Yeah, absolutely. Like I said, we're prioritizing a sale right now. I guess the first question is, what would we do with those proceeds? As the dust settles, it would be our thought that we would pay down some debt. We'd have a balanced approach. We'd pay down some debt, but we would also return capital to shareholders through share repurchases. As you move into 2026, we will be very focused on executing in 2026. Depending on what multiple our stock is at right now, there's no better value than buying Teleflex in my mind, where our multiple is at. I think that there's no way you could buy a company outside of Teleflex at our current multiple and get a better return than putting capital to work within Teleflex.
For 2026, we're going to be very, very focused on execution on our plan, ensuring we get that mid-single digit solidified, ensuring we drive good solid earnings growth, integrating the BIOTRONIK VI business, and proving out the hypothesis of why we're separating into two companies. I think that's really important. I think, as I said earlier, we're going to invest more in R&D so that more of our growth is going to come from internal developments. We'll augment that in the future with smaller tokens. It is very dependent on where our multiple is at, whether you'd even consider doing a token depending on if you give a better return for buying Teleflex stock. You can see our capital deployment is going to be very balanced moving forward.
For 2026, we would be focused on, as I said, returning that capital to the shareholders if we were able to consummate a sale. Moving forward, you could see it being quite balanced between internal R&D and returning capital to shareholders with smaller tokens out in the future.
We just have a couple of minutes left. I'll ask maybe two more questions. One is, I think it might just be worth touching on. You mentioned the balloon pumps. Maybe just talk about what happened here in the last quarter and how that changed from your initial forecast and I guess what that means for the future of NewCo.
Yeah, absolutely. When we announced the balloon pump strategy on foot of the competitor issue, a competitor in Q3 last year had an issue where they had a field corrective action on their product. At that time, the business annually is around $250 million globally, and we had about 1/3 market share, less than a third in the U.S., more than 1/3 in Asia-Pacific. At that stage, we continued to execute. We got approximately $10 million of additional revenue in Q4 of 2024. The business before that was growing good solid double digits because we were taking share anyway. We came into this year. A lot of big systems were converting to the pumps, doing full systems conversions. We always anticipated in 2026 that it would slow because we had pulled forward replacements from 2026 and 2027.
What we saw in Q3 was it started to slow earlier than we had anticipated. We thought we would do about $110 million this year, which was not an unreasonable assumption. Now we believe we will do around $80 million. The bulk, vast majority of the $30 million call down was in the United States. Getting feedback from customers, they are telling us, number one, it is not a recall. It is not a class one recall. It is a field advisory notice, which they do not believe is compulsory for them to change their product. We have given them the mod information that shows that they should reconsider that. The second feedback from customers is they are capital constrained, and they have other areas that they are spending their capital on instead of replacing their balloon pump fee. I think we executed well. We took a lot of share.
We've gone from about 30% share in the United States to 40%-45% share in the United States. That's good movement. What does it mean for NewCo into next year? All the purchasers that we were talking to were aware of this dynamic. There was nothing we told them on the Q3 earnings call that would have been a surprise to any of the interested parties. What it means is that it's not really going to have an impact on 2026 because we'd anticipated this. It just started a little bit sooner.
Great. I think we do have to end there. I think we're at time. Thanks so much for your interest in Teleflex, and thanks for your time.
Thanks, Matt.
Cheers.