Teleconferência de Resultados do 3T 2026 da Artivion (AORT): Receita Sobe 9%, Lançamento do Nexus Dentro do Cronograma

Principais destaques

• A receita do terceiro trimestre de 2026 cresceu 9% na comparação anual em moeda constante, para US$ 123,8 milhões. Excluindo o PerClot, o crescimento em moeda constante foi de 8%.
• O EBITDA ajustado recuou 8%, para US$ 22,5 milhões, enquanto a margem EBITDA ajustada caiu aproximadamente 350 pontos-base, para 18,2%.
• A receita com endopróteses aumentou 12% e a receita com On-X cresceu 13%. O processamento de tecidos recuou 0,3%, enquanto o BioGlue aumentou 0,1%.
• A margem bruta caiu de 65,6% para 61,4%, refletindo o mix de produtos e os custos relacionados à expansão da capacidade nas fábricas do On-X e do Nexus.
• A administração reduziu o intervalo das projeções de crescimento da receita em moeda constante para 2026 para 8% a 10%, equivalente a uma receita reportada de US$ 484 milhões a US$ 492 milhões. A projeção para o EBITDA ajustado foi ajustada para a faixa de US$ 93 milhões a US$ 98 milhões.
• A Artivion espera a primeira receita expressiva do Nexus nos EUA em janeiro de 2027. A administração afirmou que a demanda e o feedback dos cirurgiões continuam encorajadores antes do lançamento comercial.

Principais dados financeiros

O fluxo de caixa livre incluiu um pagamento de marco regulatório de US$ 13,3 milhões relativo à aprovação PMA do AMDS, classificado como fluxo de caixa operacional, e aproximadamente US$ 2 milhões em despesas de integração da Endospan. Excluindo esses itens, a administração descreveu o fluxo de caixa livre remanescente como relativamente neutro.

Desempenho operacional e dos negócios

A receita de endopróteses cresceu 12% pelo segundo trimestre consecutivo. A administração reconheceu que as operações internacionais subjacentes de endopróteses desaceleraram em alguns períodos, mas continuou a caracterizá-las como um negócio com potencial de crescimento de dois dígitos ao longo do tempo.

O volume de implantes do AMDS aumentou em relação ao 2T após a aprovação PMA nos EUA. No entanto, as vendas de kits iniciais permaneceram limitadas pela exigência de compra antecipada de aproximadamente US$ 100.000 por parte dos hospitais. A administração afirmou que o principal obstáculo é administrativo, e não clínico, com atrasos ocorrendo entre a aprovação pelo comitê de análise de valor e a emissão dos pedidos de compra.

A receita do On-X aumentou 13%, impulsionada por um crescimento na faixa de 15% nos EUA e parcialmente compensada pelo desempenho internacional mais fraco. A Artivion encerrou o trimestre com melhor fornecimento após investir em sua fábrica em Austin. A administração espera que a capacidade adicional apoie esforços de vendas internacionais mais amplos.

A receita de processamento de tecidos recuou 0,3% diante de uma base de comparação difícil, mas superou as expectativas da administração. A receita do BioGlue teve alta de 0,1%, com o desempenho trimestral afetado pelo cronograma de pedidos de reposição de estoque dos distribuidores.

A receita na categoria outros aumentou 93%, impulsionada pelo PerClot. O acordo de transição de fabricação e fornecimento com a Baxter expira em fevereiro de 2027, e a Artivion espera a última compra em dezembro de 2026.

Em termos regionais, a receita na América do Norte aumentou 8%, na região EMEA subiu 11%, na Ásia-Pacífico avançou 8% e na América Latina cresceu 5%.

A Artivion está reforçando os estoques, contratando equipe de vendas nos EUA e preparando o treinamento de cirurgiões para o Nexus. A administração prevê o lançamento nos EUA em 1º de janeiro de 2027, com ramp-up da receita ao longo do ano. Ao contrário do AMDS, o Nexus não exige que os hospitais comprem um estoque inicial antecipadamente.

O ensaio clínico ARTISAN havia incluído 56 pacientes. A Artivion continua com a meta de concluir o recrutamento em meados de 2027. Sujeita ao cumprimento dos desfechos clínicos e a um ano de acompanhamento, a administração projeta a aprovação do E-vita LSA pelo FDA em 2029. A empresa estima que o produto possa representar uma oportunidade incremental de US$ 80 milhões nos EUA.

Projeções da administração

A Artivion reduziu o intervalo da sua perspectiva de crescimento da receita em moeda constante para o ano completo de 2026 para 8% a 10%, representando uma receita reportada de US$ 484 milhões a US$ 492 milhões. A previsão pressupõe que o câmbio contribua com um impacto positivo de aproximadamente um ponto percentual na receita reportada do ano completo.

A empresa também reduziu o intervalo da projeção de EBITDA ajustado para US$ 93 milhões a US$ 98 milhões. Isso inclui aproximadamente US$ 8 milhões em despesas relacionadas à Endospan ao longo de 2026 para preparação do lançamento, infraestrutura comercial, P&D e atividades clínicas.

A administração pressupõe que a receita do Nexus nos EUA seja insignificante em 2026, com a primeira contribuição expressiva ocorrendo a partir de janeiro de 2027. A Artivion espera que o negócio combinado da Endospan tenha um EBITDA neutro no ano completo de 2027, à medida que a receita do Nexus acelere e as despesas combinadas com P&D e atividades clínicas convirjam para 7% a 8% das vendas.

Para 2027, a administração espera que o término do contrato do PerClot crie um impacto negativo de aproximadamente dois pontos percentuais no crescimento da receita e de quatro pontos percentuais no crescimento do EBITDA ajustado.

Riscos e pontos de atenção

• A margem bruta foi pressionada por um mix desfavorável e custos iniciais de fabricação associados ao aumento da capacidade do On-X e do Nexus. A administração espera que a margem bruta do 4T se aproxime da média do ano completo, mas não forneceu projeções detalhadas de margem para 2027.
• A adoção do AMDS continua enfrentando atrasos nas compras dos hospitais, apesar das aprovações dos comitês de análise de valor. A exigência de compra antecipada de US$ 100.000 para o kit inicial segue como a principal barreira.
• A administração espera que o crescimento reportado no 4T enfrente um impacto cambial negativo de pelo menos um ponto percentual. Ela também prevê que o cronograma favorável no processamento de tecidos durante o 3T se reverta no 4T.
• O fluxo de caixa livre foi negativo no 3T, enquanto a alavancagem líquida atingiu 3,5x. A administração espera que a redução futura da alavancagem venha principalmente do crescimento do EBITDA.
• O término do contrato do PerClot pesará sobre o crescimento da receita e do EBITDA ajustado em 2027.

Destaques da sessão de perguntas e respostas com analistas

A administração afirmou que a desaceleração implícita do 4T reflete, em grande parte, o câmbio e a reversão esperada do cronograma favorável de processamento de tecidos, em vez de uma mudança na trajetória operacional mais ampla para o ano todo.

Em relação ao AMDS, a Artivion disse que geralmente obteve aprovações dos comitês de análise de valor, mas a emissão dos pedidos de compra dos kits iniciais está demorando mais do que o esperado. A empresa está ajustando o direcionamento de contas, a orientação sobre reembolsos e o relacionamento com os hospitais para reduzir essas barreiras. A administração destacou que o DRG 209 oferece maior reembolso para procedimentos complexos no arco aórtico que cobrem o AMDS, embora a conscientização dos hospitais continue heterogênea.

Para o Nexus, a administração prevê uma expansão gradual, e não um salto imediato de receita. O treinamento de cirurgiões, o agendamento de cirurgias e a ativação de contas aumentarão ao longo de 2027. Os primeiros procedimentos geraram feedback positivo dos cirurgiões, e alguns hospitais autorizaram cirurgias sem o processo completo do comitê de análise de valor devido à aplicação diferenciada da tecnologia.

A administração espera que as restrições de fornecimento do On-X diminuam após investimentos na fabricação. A empresa afirmou que volumes de produção mais altos devem, com o tempo, reduzir os custos unitários, embora a companhia ainda estivesse absorvendo despesas de expansão produtiva durante o 3T.

A Artivion planeja apresentar os resultados dos primeiros 30 pacientes do estudo ARTISAN no AATS Aortic Symposium em 19 de novembro de 2026.

Transcrição completa da teleconferência de resultados

Transcrição completa da teleconferência de resultados

Comentários da administração

Operator

keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Brian Johnston from the Gilmartin Group. Thank you. You may begin.

Brian Johnston

Good afternoon and thank you for joining the call today. Joining me from Artivion's management team are Pat Mackin, CEO, and Lance Berry, COO and CFO. Before we begin, I would 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 in time involve risks and uncertainties and are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. 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 and 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 as well as 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. Lastly, I'd like to remind you to please refer to our press release published earlier today for information regarding our non-GAAP results, including the reconciliation of these results to our GAAP results. UNLESS OTHERWISE STATED, ALL OF OUR COMMENTS IN TODAY'S CALL WILL BE USING OUR NON-GAAP RESULTS. ADDITIONALLY, ALL PERCENTAGE CHANGES DISCUSSED WILL BE ON A YEAR-OVER-YEAR BASIS. REVENUE GROWTH RATES WILL BE THE ADJUSTED CONSTANT CURRENCY RATES, AND EXPENSES, AS percentages of sales will be based on adjusted revenues. With that, I'll turn it over to the CEO, Pat Mackin.

James Mackin

Hey, thanks, Brian, and good afternoon, everybody. In the third quarter, we delivered total constant currency revenue growth of 9% and adjusted EBITDA decline of 8% year over year. These results reflect continued execution of our strategy designed to deliver long-term, profitable growth through an expanding and clinically differentiated product portfolio. From a product category perspective, ThinCraft revenues grew 12% on a constant currency basis in the third quarter compared to the same period last year. This performance is consistent with the growth rate we reported in Q2, and notably came against a tougher AMDS prior year comparison this quarter. On AMDS, the number of U.S. implants increased from the second quarter, which we believe reflects the impact of our recent PMA approval. efforts to drive adoption of this new technology. We continue to view implant increases as the most important indicator of AMDS adoption, given it reflects the real-world use and the user experience that will drive growth in the long term.

Meanwhile, U.S. AMDS set sales remain challenged. We view this dynamic as administrative and transient. We remain confident that the set sales will build as the benefits of our initiatives aim that mitigating the barriers associated with the upfront $100,000 investment for starter sets takes hold. Now for a brief update on Nexus. We believe our preparations for US commercial launch early next year are progressing well. The remainder of 2026, our focus will remain on expanding manufacturing capacity and building inventory. working through value analysis committee processes, augmenting our U.S. sales team, and preparing for broader surgeon training. Interest across the clinical community has continued to build, and we look forward to conducting our first surgeon training event in December.

In the meantime, we're continuing to support some U.S. cases on a limited basis. Feedback from surgeons using the technology has been excellent, and we believe there's a significant demand for Nexus ahead of the U.S. launch, which is expected in January of 2027. We look forward to providing additional updates on launch timing and readiness as we get closer. Ultimately, we see our comprehensive stent graft portfolio as a foundational component of our growth strategy. We believe our competitive advantages in surgeon demand will drive greater sustainable adoption and utilization over the medium term. Turning to ONIX, our third quarter ONIX revenue grew 13% year-over-year on a constant currency basis. This performance is driven by continued mid-teens revenue growth in the U.S., partially offset by lower growth internationally, which we view as a normal quarterly variation.

Importantly, we exited the quarter in a strong supply position as a result of the investments we've made in our Austin manufacturing facility. We believe that puts us in a stronger position to meet demand globally as we close the year and enter 2027 with a product that we believe is the best aortic valve on the market for patients under the age of 65. Tissue processing revenue declined 0.3% year-over-year on a constant currency basis due to a difficult prior year comp, but was ahead of our expectations for the quarter. Regarding BioGlue, revenues increased modestly on a constant currency basis compared to the same period last year. As we discussed during our previous calls this year, this product line carries a meaningful amount of stocking distributor orders, which creates some normal quarter-to-quarter variability. Importantly, our long-term outlook for BioGlue remains unchanged. Lastly, revenue in our other category grew 93% year-over-year driven by per-clot.

As we previously noted, our transitional manufacturing and supply agreement with Baxter will expire in February of 2027, and we expect the final purchase to be made in December of this year. Overall, the per-clot transaction has been a significant positive as it allowed us to turn a non-strategic asset into cash. Although it has taken us longer than we would have hoped to get to this point, we're glad to be reaching the end of these transition services and to be able to completely focus on our ongoing business. Turning to our pipeline, we continue to make progress on the Artisan Clinical Trial for our CIVO LSA product. We now have 56 patients enrolled in that trial, which is a non-randomized clinical trial, up to 132 patients in the US and Europe, to 30 centers for the treatment of aortic dissection and aneurysm in the aortic arch. We continue to anticipate completing enrollment in mid-27. We are optimistic that the trial will be successful based in part on the positive clinical results from our current generation frozen elephant trunk called the E-vita Open Neo, which we sell outside the U.S.

Following a one-year period of follow-up and assuming the trial meets its endpoints, we anticipate FDA approval for our Evita LSA in 2029, unlocking an incremental $80 million opportunity in the U.S. market. In conclusion, we continue to advance our overall strategy in the third quarter while generating solid financial and operational results. Stent graft grew 12% for the second consecutive quarter. Nexus launch preparations are on track. We exited the quarter with a much stronger supply position on ONIX. We continue to believe the fundamentals that underpin our growth strategy remain strong, a comprehensive, clinically differentiated portfolio, a focused commercial organization, and a pipeline that stands to expand our total addressable market over time.

Lance Berry

With that, I'll now turn the call over to Lance. Thanks, Pat, and good afternoon, everyone. Before I begin, I would 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. So revenues were $123.8 million for the third quarter of 2026, up 9% compared to Q3 of 2025. Per clot had an approximately 1 percentage point favorable impact to our growth rate. Excluding per clot, our constant currency growth rate was 8%.

Meanwhile, adjusted EBITDA decreased approximately 1%. approximately 8% from 24.6 to 22.5 million in the third quarter of 2026. Adjusted EBITDA margin was 18.2% in the third quarter of 2026 and approximately 350 basis point decrease from the prior year. primarily driven by costs associated with the endospan business and gross margin, which was impacted by MIX and investments in the ONIX and NEXUS manufacturing facilities. From a product line perspective, stent graft revenues increased 12 percent, onyx grew 13 percent, tissue processing revenues decreased 0.3 percent, and bio-glue revenues increased 0.1 percent in the third quarter of 2026. On a regional basis, revenues in North America increased 8 percent, EMEA increased 11 percent, Asia Pacific increased 8%, and Latin America increased 5%, all compared to the third quarter Q3 gross margins were 61.4%, a decrease from 65.6% in the third quarter of 2025, as favorable pricing was more than offset by unfavorable mix and some higher costs in our Onyx and Nexus manufacturing facilities, as we incur early costs associated with ramping production. General administrative and marketing expenses in the third quarter were 63.2 million compared to 57.3 million in the third quarter of 2025. Non-GAAP general administrative and marketing expenses were 57.7 million, or 46.6% of sales in the third quarter, compared to 53.6 million, or 47.3% of sales in the third quarter of 2025. Approximately 120 basis points of year-over-year improvement was driven through leveraging existing infrastructure while absorbing costs associated with the acquired Endospan business, and approximately 30 basis points of leverage from stock-based compensation, which were partially offset by approximately 80 basis points of deleverage from increased amortization expense following the acquisition of Endospan.

R&D expenses for the third quarter were 9.8 million or 7.9 percent of sales compared to 8.1 million or 7.1 percent of sales in the third quarter of 2025. Interest expense net of interest income was 8.4 million as compared to 5.9 million in the prior year. Other income and expense this quarter included foreign currency translation losses of approximately 0.6 million. Free cash flow was negative 17.6 million in the third quarter of 2026 as compared to positive 17.7 million in the third quarter of 2025. This quarter's free cash flow was unfavorably impacted by 13.3 million for a portion of the AMDS PMA milestone payment that was required to be classified as operating cash flow. as operating cash and approximately 2 million of endospan-related integration expenses. Excluding these items, remaining free cash flow is relatively neutral, as anticipated, as we continue to invest in the Onyx manufacturing facility and incur costs to run the acquired Endospan business and to prepare for a U.S. Nexus launch. As of September 30, 2026, we had approximately 48.4 million in cash and 363.8 million in debt, net of 6.2 million of unamortized loan origination costs.

At the end of the third quarter, our net leverage ratio was 3.5, reflecting the impact of the recent $25 million AMDSP. PMA milestone payment in July. And now for our outlook for 2026. We are narrowing our expectation for adjusted constant currency growth to now be between 8 to 10 percent for the full year 2026, representing a reported revenue range of 484 to 492 million. This guidance continues to contemplate FX have an approximate one percentage point tailwind on as reported revenue for the full year. As a reminder, the guidance assumes inconsequential revenue from U.S. nexus sales in 2026 as we seek value analysis committee approvals and build supply for an anticipated January 1, 2027 U.S. launch. With these revenue expectations and including the impact of the Indespan acquisition, we are also narrowing our full year 2026 adjusted EBITDA to be in the range of 93 to 98 million. As a reminder, this guidance included our expectation to incur approximately $8 million of expense associated with the acquisition of Endospan through 2026 associated with investments in launch costs and commercial infrastructure while also accounting for the absorption of Endospan operating costs, including ongoing R&D and clinical expenses.

Looking forward, we would expect the first meaningful revenue contribution from Nexus to begin in January 2027, and we anticipate our combined results to be EBITDA neutral for the full year 2027 as U.S. Nexus revenue ramps over the course of the year and as we align combined R&D and clinical spending into our targeted range of 7% to 8% of sales. As we look into 2027, we are anticipating a 2 percentage point revenue growth headwind and a 4 percentage point EBITDA growth headwind attributable to the completion of our PerClot agreement with Baxter as Pat mentioned previously. With that, I will turn the call back to Pat for his closing comments.

James Mackin

Thanks, Lance. Overall, we're encouraged with our Q3 performance and the key areas of progress we've made thus far in 2026. With Nexus and AMBS, we have strong conviction in our longer-term growth outlook. We continue to build our broader market expansion pipeline, particularly with the artisan trial enrolling on schedules. More specifically, we believe our future growth will be driven by four primary U.S. orthopedic growth platforms, which collectively represents $430 million in U.S. market opportunity today with an additional upside from expanding innovation pipeline. First, AMDS. We're seeing strong implant increases with AMDS following the USPMA approval and believe that soft launch hurdles will prove transient as we further unlock the estimated 150 million annual US market opportunity. Second, On-X heart valves. We continue to educate physicians on the compelling clinical data demonstrating improved survival and lower re-operation rates for patients under 65 compared to bioprosthetic valves. We believe this data will continue to drive greater global adoption and market share gains for the On-X valve, representing an additional 100 million U.S. opportunity.

Third, Nexus. We're excited to acquire the Nexus platform following the FDA PMA approval earlier this year. In addition to providing an estimated $100 million U.S. market opportunity, the acquisition positions Artivion as a leader in the aortic arch repair and significantly strengthens our innovation pipeline with three additional PMA programs currently under development. And fourth, the ARTISAN trial. We continue to make excellent progress in enrolling our FDA IDE trial called ARTISAN. Our next generation frozen elephant trunk platform. We believe this technology represents an additional $80 million U.S. market opportunity and further expands our long term growth runway. 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

Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. press star 2 if you would like to remove your question from the queue. For participants using speaker equipment it may be necessary to pick up your handset before pressing the star keys. One moment please while we poll for questions. Our first question comes from John Macaloney with Stiefel. Please proceed with your question.

Perguntas e respostas

John McAulay

Hi, Pat. Hi, Lance. Thanks for taking the question. Wanted to start off on guidance, sort of a two-part question. looks like the implied rate growth rate in the fourth quarter, something like mid single digits, maybe six, 7%. If you add in the FX impact, seems like that's the exit rate. I just want to clarify if there's any kind of dynamics with the slowdown versus what you're seeing in the third quarter. And then just looking ahead to next year, just again wondering, you highlighted a couple dynamics with per-clot. You also have, you know, comps that have a decent amount of AMDS in them. sales in the first half of the year. I just wanted to know how we should maybe be looking at that exit rate in the context of the or per-clot changes for next year.

Thanks.

Lance Berry

So, I'll take that. On Q4, I think first of all, I think it's important for people to understand, you know, currency's been a tailwind through the first half of the year. It was neutral in Q3. In Q4, it flips to a headwind, at least a percentage point headwind in Q3. So when you look at the as reported numbers, you need to keep that in mind. I think the other thing too, we overachieved in the on the preservation services line in Q3 by a decent amount. I don't know if you remember on the Q2 call, we had really strong tissue performance, but said that we had expected that really to be timing in reverse in Q3. We were able to kind of keep it going and overcome that in Q3, But honestly, we think that's timing and it's going to reverse in Q4. So really a lot of the overachievement in Q3 is just going to reverse in Q4 on that preservation services line.

So that's really kind of noise between quarters that over the course of a year would even out, but does make the exit rate. rate look a little lower for Q4, but it's really not as you think about it rolling into the full year next year. So that's one on Q4. And then I think we're not going to get into a bunch of details on 27. I think the easy way to think about it is whoever you are, if you had not contemplated the fact that per-clot was going to go away, which I assume most people had not, you're Whatever you were thinking on 27 for revenue, you should probably just take two percentage points off of that. And whatever you're thinking for EBITDA growth, you should probably take four percentage points off of that. And that's probably a good starting point as any.

John McAulay

Thanks, that's super helpful. And just another one on AMDS here. Talked about increasing implant volumes, which is certainly an encouraging sign. at the same time, obviously still some headwinds on the set sales front. I guess my question is, you said specifically, I think, Pat, that the set sales hurdles will prove transient. I just wanted to follow up on that point. I mean, is there something you're seeing in the field that makes you feel like these headwinds.

James Mackin

are lessening? Yes, so, yes, I would say the good news is that, you know, the bottleneck for these starter sets is really an administrative problem, not a clinical problem, right? People have to pay $100,000 to buy the starter set, and it's proving more difficult than at the beginning of this. So it's, you know, we're getting VAC approvals and then it's taking us forever to get the POs, just it's different at every hospital. The part that's really encouraging is this implant activity is really moving in the right We've had great clinical experience. There's a short physician learning curve. So, you know, that part of it I think is very encouraging. So we continue to see the implants, you know, doing better in Q3 than they were, excuse me, in Q4 than Q3. And I think probably the most important thing is that even though getting these accounts started is challenging.

We've got great evidence and we continue to bring on new accounts and the implants are getting better, so the long-term opportunity is great. Understood. Thanks for taking the questions.

Operator

Our next question comes from Bill Papanastasiou with Canaccord Genuity. Please proceed with your question.

William Plovanic

Great, thanks. Good evening. Can you hear me okay? Yes. Oh, excellent. I want to focus in on the aortic stent grafts. You know, I think in last year, the core underlying business saw like a mid-teens growth rate. I mean, if you're putting up 8%, I would assume that that core underlying business is more in the mid-single digit at this point. Right. That's my first question. And then just second question is on, you know, some of these challenges, I don't, can you give us a feeling for kind of what the VAC backlog looks like? You know, how many of those have pushed through and you're waiting to get the PO filled? You know, and this This is something you've been working on. I mean, we've been talking about it for four to six months. Like, how do you get the dam to break on this? What needs to happen here?.

Lance Berry

I'll take the stent grafts and then Pat can comment more on the thoracic sets. I think it is pretty clear looking at the numbers that that core stent graft, certainly in some of the quarters this year, is below the kind of mid-teens that we've seen in the past. You can kind of also see that if you just look at our international growth rates, where a lot of our, most of our stent graft revenue is. That has slowed down some. I think we still feel really good about that business going forward and that it being a solid double digit growth rate business you know it gets bigger every year but we really have a a good portfolio of products, a lot of which are very differentiated outside the US. Those continue to grow and we think have great opportunities. So it may not be able to be mid-teens all the time and they come down a little bit off the bat, but we still see that as definitely a double-digit growth business looking into the future. Yes, it has in certain quarters, but not all quarters.

Yeah, in third Q. Has it dipped into the single digits.

James Mackin

Okay. And then Bill on the kind of the starter sets. I think what's interesting is the, we thought getting through the VACs, and we're not having any problems getting through the VACs. In fact, I don't think there's any VAC that we've not gotten through. The new piece is getting the PO actually in the $100,000. So it's different in every single hospital. There just aren't a lot of examples where most companies come into a competitive market and there's consignment on the shelf from the competitors so they just put consignment on. And we chose not to do that this is a very unique technology, a life-saving, it only has four SKUs, so we're having people buy four up front for $100,000.

So what we're finding is that that's becoming quite a challenge in these kind of bureaucratic hospital systems, and it's different at every level. every center. So we're working on different programs to knock down the barriers of getting that initial starter set. And we've seen some progress in that area. But again, it's taken a long time in some places, longer than we would like.

William Plovanic

Okay. And then, you know, on this ONIX, it seems like, you know, last year you had a really good run. The growth rates accelerated significantly and it decelerated significantly this year. I mean, you're now coming into the low teens. Is there something that's happened, like, you know, you got the first bump or first wave of adopters? and now the heavy lifting kind of kicks in with marketing and creating awareness or just any clarity around that would be helpful. Thanks for taking my questions.

Lance Berry

Maybe I'll start with some numbers and see if Pat wants to add on to that. We said at the beginning of the year we thought Onyx would grow into mid-teens, and it grew a little faster than that in the first half of the year, but it had easier comps. I still think we'll get to mid-teens for the full year this year. And we also said specifically in the script that North America or U.S. specifically grew faster. They did grow in the mid-teens and really the lower growth rate this quarter was more about normal kind of international fluctuations. Now, I also will say that we exited Q3 probably in the best supply position for Onyx than we've had in several years. So that's not going to immediately turn into revenue for international.

The international team now has to go out and sell. out and go get new business, but they are in a position where they can now do that with So we still feel really good about ONIX and I'll let Pat talk about... Yes, no, I think the... I think the... I think the... I think the... I think the...

James Mackin

The supply thing, don't underestimate the supply piece, which is, as Lance commented, we grew U.S. ONIX in the high teens and international was less than that. There's some quarter to quarter variation, but also they've been supply constrained. We've invested, as we've talked on previous calls, significantly in our Austin manufacturing facility. And we're now at a point where we can get way more aggressive. So we're very bullish on this ONIX opportunity. And every month a new paper comes out that talks about how great mechanical valves are compared to either tissue surgical valves or TAVR valves in patients under 65.

So we've got data on our side and now we've got supply and so we're going to keep going after this opportunity.

Operator

Thank you. Our next question comes from Suraj Kalia with Oppenheimer. Please proceed with your question.

Shaymus Contorno

Hi Pat, hi Lance, this is Shamus on for Suraj. Thank you for taking our questions. Just to start, you know, Nexus, we know you've been working on VAC approvals and committees and whatnot. Just can you frame up kind of how we should expect from our side the launch? You know, you guys have kind of been working at this for a few months, January 1st you kind of are turning on the lights. Just how should we kind of think of that initial jump? Is it kind of opening up the spigot a lot or is it going to be a kind of slow drip through 27?.

James Mackin

Yes, so first of all, we're very excited about Nexus. We just got the PMA and closed that acquisition in the last quarter. We have done cases in the second half, and the most important thing there is the surgeon feedback has been extremely positive. We see a lot of opportunity with Nexus going forward. We've been taking this time to basically build inventory for the US launch, hire our reps, build up the sales channel. We've got a launch meeting in two weeks at Vieth, and then we have our first surgeon training in December. So, this is going to roll out in a typical fashion, right? Once you train your surgeons, We've got to get their cases on the books and start doing cases.

This will build throughout the year as we bring on those new cases. So, it's also a very different model than AMDS that make it easier from an adoption standpoint because we don't have the starter set issue. These are elective cases. There is no consignment, but there is no inventory. They don't have to buy anything up front. They basically bring the devices in for the procedure with our rep. They do the case, and then we get the PO. I think all that having to buy the upfront set isn't going to exist. and should make it a lot easier.

The other thing we've been very surprised by is that we've done a bunch of cases in hospitals that haven't had to go through VAC. We're getting them as we go through. I mean, we're obviously building up our position with these VACs, but we've done a bunch of cases where they've been able to kind of sidestep the VAC approval because it's such a unique technology for treating patients with aortic arch disease with a minimally invasive catheter system.

Shaymus Contorno

Got it. Appreciate all that info. On AMDS quick, I mean, I know we've kind of talked about, you know... A lot of it, there being kind of barriers to that 100K set sales, I guess, two little points you could on it, you know, when do you kind of see that kind of starting to subside? Is this kind of, you know, another six months, another year? Like when do you kind of we should expect that kind of to open up a little bit better? And then, you know, just how did kind of new accounts kind of track on your end quarter over quarter? Do we see kind of that barrier, is it just holding or is it kind of consistent or is.

James Mackin

or has it lessened? Thank you again for taking our questions. Yeah. look at the big picture with AMDS. We've got these tremendous clinical results, And those have been kind of reaffirmed throughout the launch. So I think that's very important. I just went to a surgeon training a couple weeks ago and every surgeon that walked out of there was a believer in AMDS, right? So we gotta go back and get their starter set. But if you look at the big picture, you know, there's probably 800 centers that do acute type A dissections in this country. The high volume ones are probably in the 300 to 400 range.

So we've got a lot of runway on bringing accounts on through this kind of starter set. And as we do that, we're seeing the implants follow in ramp, which is what we're seeing. So I think we're going to be opening new starter sets for the next couple years. We're going to obviously try knock down those barriers and make it faster. But I think the opportunity is intact, and we're very confident about the ability to go after this market.

Operator

Our next question comes from Frank Tikkanen with Lake Street Capital. Please proceed with your question.

Anna Yang

you guys can you yes okay yes what's on for Frank I'm kind of building off of Seamus's point here with q3 being that first quarter of Omni under full PMA what are you guys seeing with the new adoption and accounts versus utilizing and existing ones and as the approval has changed have we seen any pace of conversions with centers that have been waiting on the sidelines going quote.

James Mackin

Yes, so I would say, you know, the PMA didn't do anything for the administrative burden in getting the PO. I mean, to me, that's a – we get through a VAC committee, whether it's a PMA or an HDE, it really hasn't mattered. So that, I don't think we saw much help on the PMA from that. I do think we've seen, I mean, the numbers show that we've seen the implants have actually accelerated. And I think it also creates opportunity for accounts that weren't necessarily interested in an HDE, now that we have a PMA, to bring on those accounts. Again, it's a net positive, but it's going to take us some time to kind of bring those accounts on that were not going to go through the whole IRB process.

Anna Yang

Got you, thank you. And I just got one more follow-up here. Looking back at the end of 2025, you're at about 1.8x. net leverage for acquiring Endospan. I know you've mentioned about wanting to get back to that two times leverage point. What's a reasonable timeline and what do you think needs to be executed to get back.

Lance Berry

to this level. Thank you. Yes, I think the main driver of that is just going to be EBITDA growth. You know, we do expect to next year, you know, over the course of the year flipped to being more meaningfully free cash flow positive. But we do need that cash flow to pay earnouts for AMDS and Nexus in 2028 and 2029. So realistically, the leverage reduction is going to come primarily through EBITDA growth. All right.

Operator

Thank you. Our next question comes from Michael Sarcone with Jefferies. Please proceed with your question.

Unknown Speaker

Hey, good afternoon, and thanks for taking the question. I guess just to start, Pat You mentioned you're working on different programs to knock down some of those starter set barriers for AMDS. I believe you had also mentioned some education initiatives. in your prepared commentary. I guess, could you elaborate a little more on the efforts you're taking there and just given that things remain challenging, I guess, what do you think isn't resonating here for folks?.

James Mackin

Yes, well, one that's, I guess it makes sense because the dissemination of information always takes longer than you'd like. I think one of the biggest is this DRG 209 that went in place October last year which provides a significant increase in reimbursement for complex arch work, which covers AMDS. So it's amazing to me that hospitals more and more, like just hospitals aren't aware of the information. So I meet with some of the top surgeons in this field all the time. And, you know, getting that information into the administration is, you know, takes some time. So I think that's another great kind of, to not have that barrier and have it be a positive is a real big plus. And we're also doing a number of things from, I mean, it's like any launch, you learn as you go and you make adjustments.

It doesn't always go in a straight line. And so, you know, we've done a number of things from kind of the surgeons we're targeting, how deep we go into accounts, and we're all over this from a, you know, kind of an adoption standpoint. So it's a real focus of ours, and we're starting to see the fruits of that focus.

Unknown Speaker

Got it, thank you. That's helpful. And my follow-up, maybe for Lance. You talked about some gross margin headwinds now as you're ramping some of the manufacturing facility build-outs. When you looked at 2027, can you talk to us high level or qualitatively about the moving pieces or the puts and takes for gross margin? And I guess the underlying question is really, do you think you can expand gross margins in 27?.

Lance Berry

Yes, I guess we'll not get into details on 27 other than the per-clock comments we mentioned earlier. I'd say qualitatively the things that weighed on gross margin this quarter, I'd put into kind of three categories. One was kind of normal mix. We talked a little bit about overachieving on the preservation services business, which is never great for gross margin, although it doesn't hurt EBITDA margin. We definitely made some big investments in our ONIX facility and are just now starting to see really the capacity improvements that are going to end up getting that cost back down to where we want it to be and ultimately below where it was. And then same thing. with Nexus, we're investing money for a launch, but the volume is just not quite there yet. That I really view as all timing.

It will clear itself out. In the end, both those plants will have significantly higher volume than they had in the past, which is really a good opportunity to improve unit cost. Right now we're on the other side of that. And then lastly, I will say, it wasn't in the prepared comments, but we did have a few period charges this quarter that really should be things that shouldn't repeat, that weighed down. I would say those were not as big a deal as the other two items, but we did have a little bit of that as well. Okay. Thanks, Lance.

Operator

As a reminder, if you would like to ask a question, please press star 1 on your telephone keypad. next question comes from Keith Hinton with Freedom Capital Markets. Please proceed with your question.

Keith Hinton

Great, thanks. Just two quick questions. I'll ask them both up front. Starting with just on the gross margin side of things, I think you talked about three issues, you know, mix, some of the on-ex and then the Spain manufacturing, and then some one-timers. So I'm just curious if those latter two, if you could kind of quantify that, and particularly on the on-ex. Endospan investments, how we should think about that in 4Q and going into 2027. Will that continue to be a headwind? And then the second question, real simple one, just on Artisan. Since this is a open-label single-arm trial, any chance we see data on some early enrolled patients? before 2028.

So that's it, and I'll hop back into Q. Thank you.

Lance Berry

Yes, Keith, I'm not going to get into the nitty-gritty details other than I would say Q4 we definitely expect to be more in line with the full-year schedule. year average number for gross margin. So, and that's through a combination of the period cost not repeating and then starting to see the volume ramp in both facilities, so, you know, current expectation is we would see something, you know, more in line with the full year average. It might be a little bit below but I don't think, don't expect to see something like we saw this quarter.

James Mackin

And then for Artisan, we are going to be our first 30 patients. So as I mentioned in my prepared remarks, we've enrolled 56 to date. The first 30 patients are going to be presented at the AATS Aortic Symposium Two weeks from today on Thursday, November 19th, by the chief aortic surgery from Cleveland Clinic, Dr. Eric Roselli. So you will see the first kind of 30 at that presentation. It's a late-breaker main stage presentation. Great, thank you.

Operator

Our next question comes from Jeff Cohen with Ladenburg. Please proceed with your question.

Unknown Speaker

Hi, thank you for taking our questions. This is Destiny on for Jeff. Just one quick one for us. I know it's still, you know, relatively early. I'm wondering though if you could speak to the demand or level of interest you're seeing from surgeons ahead of the Nexus commercial launch in January.

James Mackin

Thank you. Yes, no, I mean, it's been very encouraging. I mean, like I said, we were not in an inventory position after the acquisition of the launch in the US. So we've been doing, you know, a handful of cases and, you know, really, really excellent surgeon feedback. And as I mentioned earlier, we're going to be doing our big launch meeting in two weeks at VEATH. We then have surgeon training in December. And we've got our reps already ramped up, the inventory's ramping up, and we launch on Jan 1. So, as I mentioned, it'll build through the year.

We've got a lot of VAC committees already done, and a lot of these early cases have been done without VAC because of the uniqueness of this technology. So we're very excited about Nexus for 2027. Got it. Thank you so much.

Operator

Mr. Mackin, there are no further questions at this time. I would now like to turn the floor back over to management for closing comments.

James Mackin

Yes, well, thank you very much. And I guess I would just close on, you know, We meet with aortic, cardiac and vascular surgeons all the time from the largest centers and one of the things that gives me a lot of confidence is we're working on all the things that they're interested in, right? So acute type A dissections with AMDS and our frozen elephant trunk, our SIBO that's currently in trials, um, our mechanical aortic valve On-X in patients under 65. They've got a new minimally invasive technology with Nexus to treat those patients. So, we're very much aligned with our key customers on where we're taking this company and our growth platform. So, we look forward to continue to build the company. Look forward to reporting out again in February. Thank you.

Operator

This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation and have a wonderful afternoon.

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