Artivion Q3 2023 Earnings Call Transcript

Quartr
Provided by Quartr
November 2, 2023

There are 9 speakers on the call.

Operator

Welcome to the Artibian Third Quarter 2023 Financial Conference Call. At this time, all participants are in a listen only mode. A brief question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. I will now turn the call over to Lane Morgan from Gilmartin Group.

Operator

Thank you. You may begin.

Speaker 1

Thanks, operator. Good afternoon, and thank you for joining the call today. Joining me today from Artuvion's management team are Pat Mackin, CEO and Ashley Lee, 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.

Speaker 1

The forward looking statements include statements made as to the company's or management intentions, hopes, beliefs, expectations or predictions for 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 those 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 detailed highlights on today's call on the Investor Relations section of the Atuvion website. Now I'll turn it over to Artemium's CEO, Pat Malkin.

Speaker 2

Thanks, Laine, and good afternoon, everyone. I'm pleased to report we made outstanding progress on our goals this quarter. As you will hear today, the team has made substantial progress across the board in the Q3 Commercially, operationally and financially. In addition to delivering top and bottom line growth, we also achieved clinical development milestones. As of today, we have 2 patients remaining to complete the enrollment in the PERSEVERIA clinical trial in October.

Speaker 2

Also, Ambeus and ONUS clinical study results were presented at EX, the European Society of Cardiac Surgery that demonstrated unprecedented clinical outcomes. I'll detail these positive developments 1 by 1, starting with our financial results. We delivered constant currency revenue growth 12% year over year in the Q3, resulting in $87,900,000 in revenue. Our strong performance was led by improved revenue growth in our stent graft business, which increased 22%, followed by On X 13%, tissue processing 12%, when compared to the Q3 2022 on a constant currency basis. We're also benefiting from expansion of our commercial footprint through regulatory approvals in new geographies.

Speaker 2

Our strong top line performance led to $13,900,000 in non GAAP adjusted EBITDA in the 3rd quarter. This is a 34% increase compared to the Q3 of last year. We expect our strong momentum in the 1st 9 months to continue through the Q4 and into 2024. We're very optimistic about our future as we've ever been. At our Investor Day in March of 2022, We committed to delivering compounded annual double digit constant currency revenue growth through 2024.

Speaker 2

Also driving further operating leverage And adjusted EBITDA of $75,000,000 in 20.24. Again, we are reiterating our expectation to achieve these goals. Our commercial team is also executing extremely well. As I mentioned earlier, Stent Graph revenues grew 22% on a constant currency basis in the 3rd quarter compared to the Q3 of last year, driven by improved supply and strong performance in AMBS and Nexus. We anticipate demand to remain strong for the balance of 'twenty three and beyond for our stent graft products, which should continue to sustain our strong revenue performance.

Speaker 2

Additionally, Onex revenues increased 13% compared to the Q3 last year on a constant currency basis. We continue to take market share globally with the only mechanical aortic heart valve that can be used with an INR of 1.5 to 2.0 in the aortic position. We believe our valve is the best aortic valve in the market and our market share gains each year clearly support this view. And finally, tissue processing revenues increased 12% compared to the Q3 of last year on a constant currency basis, primarily due to pricing initiatives. As you may recall, part of our organic growth story has been to expand into new markets.

Speaker 2

We have done that effectively and We've also expanded our operations in APAC and Latin America. Through new regulatory approvals and commercial footprint expansion, APAC and Latin America delivered constant currency revenue growth of 21% 22%, respectively, compared to the Q3 of last year. We expect these regions to be important growth drivers over the coming years as we continue to leverage our industry leading product portfolio further into these regions. In addition to our strong financial performance, we made significant progress on our clinical programs and saw extremely impressive data readouts for On X And AMDS at the recent European Association of Cardiac Surgery in Vienna. First, I'm extremely pleased to report that we've nearly completed The enrollment for PERSEVERE, which is our ID trial for the US PMA consisting of 93 participants who've experienced an acute Type A aortic dissection.

Speaker 2

At this point, we only have 2 patients remaining to complete enrollment in the trial. As a reminder, the combined primary efficacy and safety endpoints of this trial A reduction in all cause mortality, new disabling stroke, myocardial infarction and new onset renal failure requiring dialysis, as well as the occurrence of GAIN tears, which are distal and ophthalmotic new entry tears, which are associated with increased risk for re intervention in mortality. GAIN can occur in up to 70% of patients following hemiarch repair without AMDS and allows continued blood flow into the false lumen created by the dissection. Interim results of the PERSEVER study, which is our FDA pivotal trial, have shown there have been no in any patients treated with AMDS nor were there any dane tears reported in the DARTs study after 3 years of follow-up. As I will discuss shortly, clinicians have so far seen incredible outcomes with AMDS across these endpoints.

Speaker 2

Additionally, the FDA has granted us continued access for approval to continue our enrolling of up to 40 additional patients in the PERSEVERE study, so physicians and patients in need can access this life saving technology while we Following the 1 year follow-up period and assuming the trial meets its endpoints, we continue to believe that we should receive FDA approval for the AMDS device in the second half of twenty twenty five. In addition, our partner EndoSpan is making progress on its U. S. IDE trial called Triomp for its Nexus aortic repair stent graft system. As a reminder, the PMA will be based on the results of 60 patients in the chronic dissection arm of the trial.

Speaker 2

At this point, there are 41 patients enrolled out of 60 in the trial. Based on the current enrollment rate, the pivotal arm of this trial should enroll in the first half of twenty twenty four and after a year of follow-up This would put Nexus on track for an approval sometime in mid to late 2026. To reiterate, if these PMA trials proceed as anticipated, we expect FDA approval on AMDS in 25 and Nexus in 26. At that time, assuming we exercise our option for EndoSpan, these two products would significantly increase our addressable market opportunity. At the recent EX meeting in Vienna, 2 of our products were featured in late breaking presentations.

Speaker 2

First, interim data from the AMDS PERSEVERA clinical trial, Which is a 30 day combined primary endpoint for data in the first 52 out of 93 patients that were enrolled showed clinically meaningful reduction The target goal of this trial was a 31% reduction to reach 40% of patients with greater than or equal to 1 major adverse event. The data in the 52 out of 93 patients that were presented at EX showed a 21% of the patients had greater than or equal to 1 major adverse event. That's a 64% reduction. We are incredibly pleased with the very positive interim results which have demonstrated the life saving nature of AMDS, including a statistically significant reduction in mortality, renal failure causing dialysis and myocardial infarction. We expect this data will drive AMDS device adoption and hence revenue growth in markets where AMDS is currently approved.

Speaker 2

2nd, data from our 510 patient On X heart valve low INR post market study with a follow-up with a mean follow-up of 3.4 years showed a statistically lower composite primary endpoint of thromboembolism, valve thrombosis and major bleeding. These results are driven by an 85% reduction in major bleeding and a 73% reduction in all bleeding. This data reflected an improvement in outcomes compared to the original On X low INR pivotal arm, which showed about a 63% reduction first published in 2014. This is the basis of our current low INR label. With these data, we are increasingly confident in our ability To gain further market share globally with On X, it's the only mechanical aorticard valve that can be maintained at an IRR of 1.5 to 2.0, which is backed by recommendations from ACC, the American College of Cardiology and American Heart Association guideline for patients with valvular disease.

Speaker 2

Finally, I want to let you know that we are discontinuing our pursuit of the lower INR indication in the U. S. For On X mitral valve. As we previously reported to you, while the trial did not show an increase in thromboembolic or val thrombosis event rates, it missed its primary non inferiority endpoint. After several discussions with the FDA in which they informed us that would require additional clinical data to consider the indication for approval, We've determined not to invest in the significant time and resources it would take to secure the additional data.

Speaker 2

We previously stated that securing PMA approval for low INR indication For the Onyx mitral valve was not critical for us to achieve our growth objectives that we've communicated. Furthermore, I'm pleased to report that our Onyx mitral valve business has increased 18% year to date compared to the same period in 2022. We believe this is partially due to the compelling clinical results for patients in the trial We've been treated with the On X mitral valve and were being maintained at a lower INR. Based on the positive data from this trial, we do plan to seek Change in the existing guidelines for use of warfarin in connection with the On X mitral valve as we did with the On X aortic valve. I want to thank our investigators and subjects who participated in the trial.

Speaker 2

Before I turn the call over to Ashley, I'd like to take a minute to talk about the impact of the GLP-one receptor agonist class in medical device stocks. Right now, investors are trying to determine What the impact these drugs will have on medical procedures? Over the past couple of weeks, myself personally and our team have met with over 25 Cardiovascular epidemiologists, preventive medicine cardiologists, cardiac and vascular surgeons regarding the potential impact of this class of drugs on the disease states that we treat. Specifically aortic valve disease in patients under 65 and aortic dissections and aneurysms. We've included 2 slides, Slide 11 and 12, in the presentation included in our Investor Relations section of our website that summarize our research.

Speaker 2

More specifically, regarding aortic valve disease, The patient population we treat are under the age of 65. The primary risk factor basically is linked to a pre existing condition for those patients That has a congenital valve malformation called a bicuspid aortic valve, which make up about 60% of the patients that we treat. Further, there are very large studies with over 100,000 patients that have shown there is no relationship between obesity and aortic stenosis or valve replacement in ages under the age of 65. Based on our conversations with key opinion leaders and based on the significant data stemming from these studies on the matter, GLP-1s will have minimal up to no impact on the incident traits of aortic valve replacement surgery in patients under the age of 65. Similarly, for aortic dissections and aortic aneurysms, the primary risk factors are pre existing conditions for those patients With these disease are familial or connective tissue disorders such as Marfans, high blood pressure, smoking and high cholesterol.

Speaker 2

Similarly, these very large studies for aortic aneurysms and dissections have shown no relationship to obesity. Further, GLP-1s have minimal impact on blood pressure. Based on our conversations with key opinion leaders and based on the significant number of studies on the matter, GLP-one should have minimal impact on the incident rate for erythritosections and aneurysms. Furthermore, even if this category did have some minimal impact on our adjustable markets, You must keep in mind that the largest growth opportunities for Artivion over the next several years is the introduction of our novel stent graft technologies in the U. S.

Speaker 2

And Japan in other developed markets around the world. And in those markets, we are starting from 0. So in conclusion, we do not feel GLP-1s will have a meaningful impact on the incident rates Of the disease states that we treat and even if they did have some minor impact, the new adjustable markets that we are eventually moving into provide ample opportunity for us continuing to develop delivering double digit growth on the top line for many years. With that, I'll now turn the call over to Ashley.

Speaker 3

Thanks, Pat, and good afternoon, everyone. Revenues were $87,900,000 for the Q3 2023, up 14% on a GAAP basis and 12% on a constant currency basis, both compared to Q3 of 2022. Non GAAP adjusted EBITDA increased 34% from $10,400,000 in the 3rd quarter of 2022 to $13,900,000 in the Q3 of 2023. After generating $5,100,000 of free cash In the Q2 of this year, we generated $5,800,000 of free cash flow in the 3rd quarter. Importantly, on a trailing 12 month basis, we are free cash flow positive and expect that free cash flow on a trailing 12 month basis will continue to improve from this point going forward.

Speaker 3

On a year over year basis, in the Q3 of 2023, Stent Graph revenues increased 30%, On X revenues increased 14%, tissue processing revenues increased 12% and BioGlue decreased 7%. On a constant currency basis compared to the Q3 of 2022, StemCraft revenues grew 22%, On X revenues grew 13%, tissue processing revenues increased 12% and BioGlue revenues decreased 8%. To add some color on the decline in BioGlue revenue this quarter, in Q3 2022, we did not have CE Mark and we're using derogations to sell in Europe. At the end of Q3 2022, our derogations for the U. K.

Speaker 3

And France were set to expire, So our customers ordered an additional $1,500,000 of BioGlue so that they would not run out of this important product. As a result, we had lower Q4 sales in Q4 of 2022 and expect BioGlue to return to growth in Q4 of 2023. On a regional basis, Q3 2023 revenues in Asia Pacific increased 21%, Latin America increased 29% and North America and Europe both increased 13%, all compared to the Q3 of 2022. On a constant currency basis, revenues in Asia Pacific increased 21%, Latin America increased 22%, North America increased 13% and Europe increased 7%, all compared to the Q3 of 2022. Gross margins improved to 64% in Q3 compared to 63.4% in the Q3 of 2022.

Speaker 3

This increase was driven by price increases and product mix, partially offset by inflationary impacts on materials and labor. G and A expenses in the Q3 were $51,100,000 compared to $41,100,000 in the Q3 of 2022. Excluding charges, which primarily consist of adjustments to the fair value of contingent consideration Related to the Osiris acquisition, G and A expenses were $44,700,000 for the Q3 of 'twenty three compared to $39,900,000 in the Q3 of 2022. R and D expenses for the Q3 were $6,400,000 compared to $11,800,000 in the Q3 of 2022. The decrease in R and D spending resulted primarily from the cessation of the PROACT-9A trial Last September.

Speaker 3

Other income and expenses of $8,200,000 includes $6,300,000 in net interest and foreign currency translation losses of approximately $1,900,000 On the bottom line, we reported GAAP net loss Quarter of 'twenty three includes pretax charges of $6,200,000 related to contingent consideration for the acquisition of AMDS and the impact of valuation allowances on deferred tax assets. Non GAAP net income was $749,000 or $0.02 per share in the Q3. Non GAAP net income includes foreign currency losses and excludes business development and other nonrecurring As of September 30, 2023, we had approximately $53,000,000 in cash, $313,000,000 in debt and the full $30,000,000 available to us under our revolving credit facility. Please refer to our press release for additional information about our non GAAP results, including a reconciliation of these results to our GAAP results. And now for our updated outlook for 2023.

Speaker 3

Given our performance through the Q3, Our pricing initiatives, improvement in supply of stent grafts and FDA approval for PerClot, we are raising our revenue guidance and now expect Constant currency revenue growth of between 11% 12% for the full year compared to the previous range of 10% to 12%. We expect revenues to be in a range of $349,000,000 to $351,000,000 compared to our previous range of 3.42 to $350,000,000 With our strong third quarter performance, continued top line revenue growth, General expense management and a decrease in R and D spending. We have increasing confidence that we will meet or exceed our adjusted EBITDA guidance of a minimum of $52 plus 1,000,000 for 2023. These factors also allow us to remain on track To meet our $75,000,000 2024 adjusted EBITDA commitment we made in March of last year at our Investor Day. In regards to our capital structure, we continue to monitor market conditions and evaluate options to address the maturity of our convertible debt in July 20 And finally, our Term Loan B contains no financial covenants to maintain Unless we were to have more than $7,500,000 drawn on our revolving credit facility at the end of any calendar quarter, which we do not.

Speaker 3

As of now, we have the full $30,000,000 available under our credit facility and do not foresee the need to draw on it. As a reminder, our convertible notes do not contain any financial covenants. Overall, our strong financial performance and the expectation it will Continue through 2024 before just greater flexibility as we continue as we consider our future obligations in ways to increase shareholder value. With that, I'll turn the call back over to Pat for his closing comments.

Speaker 2

Hey, thanks, Ashley. So as you've just heard, our business is performing extremely well. We exceeded our revenue goals, increased guidance, continue to expand our markets and advance our clinical pipeline, which will meaningfully expand our adjustable market if approvals are gained. These combined factors make us highly confident that our growth prospects through 'twenty three and beyond. We expect future growth to be driven by the following.

Speaker 2

First, our continued strong growth in our stent graft business, primarily due to our improved supply and product adoption. 2nd, Our accelerating AMDS growth driven by the 30 day PERSEVERE study data that was presented at EX showing a 64% reduction in major adverse compared to literature control. 3rd, continued market share gains for On X, driven by the recent 510 patient data that was presented at E X showing an 85% reduction in major bleeding 4th, growth in our proprietary SGPV Synegraft Valve, which is driven by price increases, the growth of the Ross procedure and our increased ability to deliver from a supply standpoint. 5th, the continued growth that we've seen in Asia Pacific and Latin America from our channel investments and our new regulatory approvals. 6, our continued growth in PerClot due to the PMA approval in May of 2023.

Speaker 2

And finally, in the midterm, our robust clinical pipeline, More specifically, the completion of patient enrollment in the AMDS PERSEVERE trial, continued enrollment in the EndoSpan's Nexus Triumf trial. Combined, we expect these two opportunities to significantly expand our total adjustable market in 2025 and 2026. We have delivered on consistent double digit revenue growth this year. And as you just heard, we have great momentum as we finish 'twenty three and head into 'twenty four. I will wrap up my comments with some thoughts as we head into 2024.

Speaker 2

First, as we commented our March 22 Investor Day, we are committed to delivering double digit revenue growth. 2nd, we have made the necessary investments in our channels, our factories and our pipeline, and you will see the continued benefit of those investments in 2024. As such, our plan is to deliver $75,000,000 of adjusted EBITDA, which will reduce our net leverage to less than 3 times despite the headwinds we face In addition, on a trailing 12 month basis, we are cash flow positive and expect that Free cash flow will continue to improve going forward. Finally, I want to thank our employees around the globe for delivering an exceptional third quarter. With that, operator, please open the lines for questions.

Operator

Thank you. Ladies and gentlemen, the floor is now open for questions. And we'll take our first question from Rick Weiss from Stifel. Please go ahead.

Speaker 4

Hey, Pat. Hey, Ashley. This is John on for Rick today. I just wanted to start off with the 2 kind of really encouraging data sets we saw at EX23 and Maybe how we could think about those and the impact it could have potentially on financial performance as we look into 2024. Just specifically, I want to kind of hear, are you hearing anything from the field, just what your reps are saying, what they're hearing from doctors?

Speaker 4

Could these Data sets both potentially be growth accelerants as we look to next year and you could grow even faster and expand margins Greater than expected. You got them going.

Speaker 2

Yes. So maybe I'll take them 1 at a time. So the two data sets that I referenced in my comments Where the AMBS Persevere, that was the first 52 patients out of 93. I think The overwhelming feedback from clinicians is this is kind of game changing data, right? So we're not we're about to finish trial, we'll get the full data set and hopefully have that presented in January.

Speaker 2

But you're seeing a 64% reduction In major adverse events versus the literature control that we're being that we're using with the FDA. So as a reminder, the patients that have Acute type A dissections with malperfusion, right, so blood going in the wrong false lumen. In the literature control, if you look at the average of those At least one of those patients had 58% or 58% of the patients had at least one major adverse event. The bar that the FDA set was around a 30% reduction to got to 40%. We delivered at least in the interim analysis 64% reduction, which is a 20% of the patients had an MAE.

Speaker 2

That is a huge change. Statistically significant difference in mortality, Patients requiring dialysis and MI. So we expect and I mentioned this, we expect that data as it gets around We'll continue to drive the growth of AMDS, which is already growing very rapidly. But I think it portends for a very big opportunity in the U. S.

Speaker 2

Once We launched that. I think the second one on the On X post approval data, that's a 510 valve study. That's a very large study. And as a reminder, the original On X low INR study, which we're the only company that has it, we showed about a 63% reduction in bleeding, and that's what the PMA and the expanded label was based on. This was a post approval trial required by the In kind of real world patients, we're about 3.5 years we have 3.4 years of follow ups in those patients.

Speaker 2

There'll be more data presented at AATS in May, but you're basically seeing an 85% reduction in major bleeding and a 73% reduction in all bleeding. So it just further Contributes to the body of evidence around, the On X aortic valve and nobody else has it. We're just going to continue to go after market share with a market leading technology.

Speaker 4

Thanks. That's helpful. And then as a follow-up here, You talked a bit about ramping adjusted EBITDA to $75,000,000 next year and you're growing strong so far this year, 30% this quarter. My question is, I just want to better understand the inputs we're getting there. I get that the double digit top line growth It's critical, but we're also going to have to see some leverage on the G and A and the R and D line.

Speaker 4

So I'd just be really helpful if you could kind of talk through How you're going to generate that leverage? How quickly it's going to be more visible and just kind of the ramp throughout the year?

Speaker 2

Yes. So there's multiple factors and I mentioned some of them in kind of my closing, right. So we have a lot of things going in our favor, right. We just talked about the AMDS We've talked about the On X data. The other big thing is our synegyraft pulmonary valve is growing very rapidly.

Speaker 2

The Ross procedure, The data on the Ross procedure that's come out is phenomenal. That procedure is going extremely rapidly. We're the market share leader by far in that. We've taken some price increases there, but we've also done a lot to improve our supply. So that's going to be a real growth driver for next year.

Speaker 2

So this year, A lot of it was pricing. Next year, you're going to see a lot from a unit standpoint. So we expect that pulmonary valve business to continue to grow. That's one of the big contributors. I think the other piece is I mentioned in my comments, I mean, we're building a company here.

Speaker 2

So we've invested heavily, right? We've invested heavily in Latin American Asian We've invested heavily in the pipelines, our factories, clinical trials, all these things that we're talking about. And for 2024, We've made the investments. We're delivering double digit growth and you're going to see us drive rapid EBITDA acceleration By the top line comments that I made as well as managing the middle of the income statement, because we basically made the investments we've needed to make and you're going to see significant drop through on the P and L next year.

Speaker 4

That's helpful. And just if I could sneak one more in. I just wanted to better understand the price versus volume contribution to 3rd quarter growth and How we should be thinking about that for 2024? Is there a potential with these two data sets to potentially increase prices again? Or Are there any other areas you might be targeting for a price increase?

Speaker 4

Thanks.

Speaker 2

Yes. I mean, we look at pricing every year and We've taken some pretty significant price increases where we have highly differentiated products, which again is the majority of our portfolio. So we will look at that on a case by case basis. But clearly, that is going to be another focus for us in 2024 is Where appropriate to take additional price increases.

Speaker 3

Thanks. Thank

Operator

you. And we'll take our next question from Suraj Kalia from Oppenheimer. Please go ahead.

Speaker 5

Hey, this is Seamus on for Suraj. Congrats on the quarter and thank you for taking our questions. Just kind of looking at Onex, how should we start thinking how should we have thought about Same store new store, same store sales in 3Q and kind of 4Q and thoughts on 24 for that as well, if you can? Yes.

Speaker 2

So I mean, we've delivered 13% growth in On X for the last 5 years. And it's been a combination of it's not just when you think about a hospital, sometimes we'll get We'll get into a new hospital with 1 surgeon and other surgeons may use another valve. So it's to your analogy, same store, but then expanding in those in that store with other surgeons. So we've had very good penetration into accounts. We still have more to go.

Speaker 2

This expansion in Asia and Latin America, we've seen very nice growth in those markets. So I think this data is just out. I mean, literally, this data is not even a month old. So our commercial teams are just getting out there and making their rounds with the clinicians. But Yes, we're going to be very aggressive and we think there's this is the best valve on the market and there's no reason people should be using another one because they don't have the data.

Speaker 2

So we see this as a big opportunity for us. And like I said, we've guided a year and a half ago, we told people we could grow Onyx 10 to We've been growing at the higher end of that range, and I think we're looking at more of the same going forward.

Speaker 3

Got it. Thank you for that.

Speaker 5

One quick one for Ashley. How should we start thinking about FX exposure as we move into 2024?

Speaker 3

Well, as we round out the end of 2023, we certainly Have a little bit of a tailwind. Again, with the majority of our OUS business being in Europe, the Relationship that we pay the most attention to is the euro USD and again, we should have a little bit of a tailwind In the Q4 of this year. If you look at the forecast for 2024, and again, we just look at the consensus, we're not FX experts, but we look at the consensus and the consensus right now indicates that the dollar should start weakening from these levels going into 2024, which Again, should create another tailwind for us if that in fact happens.

Speaker 5

Got it. Thank you. And just one kind of last one, if I can sneak in. What are your kind of thoughts on these low risk TAVR signals We presented a TCT for Partner 3 and Evolut and how it relates to you guys. Thank you.

Speaker 2

Yes. I think, I mean, we saw a joint press release that came out from both the STS and the European Association Cardiac surgeons, we can make that available to you. It was pretty direct basically saying, I can read you the comments from this is from the press release from the 2 biggest cardiac surgery societies. Given that the fastest growing operation in the STS national database over the last 5 years is TAVRx plant, We advise that more follow-up and time be given to the existing low risk trials before advancing this in this patient population. They also make a bunch of comments about that they're comparing apples and oranges about 26% of the patients in these trials.

Speaker 2

The Saver group, the surgical group had a concomitant procedure done with it, whether it was a CABG or whatever, which comes with a higher risk score. And so this is again a direct quote. We call in investigators for both PARTNERSP3 and Evolut Low Risk Trials to publish their results For isolated TAVR versus isolated TAVR and see what the real data is. And the final comment was, we recommend caution prior to adopting TAVR1st strategy

Speaker 3

Sounds like a lot of

Operator

Daraush, does that complete your question?

Speaker 4

Yes, sorry. Thank you. Okay.

Operator

No worries.

Speaker 2

Yes. No, and I would encourage you guys, look, this is from the surgeons. These aren't my work. This is the 2 most powerful cardiac surgery

Operator

Thank you. And we'll take our next question from Mike Matson from Needham. Please go ahead, Mike.

Speaker 6

Hi, this is Joseph on for Mike. Congrats on the quarter and we do appreciate the commentary The GLP-one impact or I guess lack thereof. Looking at stent grafts, We've seen like 4 quarters of straight acceleration, at least on a reported basis. Just kind of curious, where does all the strength come from? What's going on with that?

Speaker 6

Do you expect I guess, based off of the guide, It looks like there could be continued acceleration into the Q4, maybe not, but maybe if you could just frame 2024 especially in that A segment for us that would be helpful.

Speaker 2

Yes. So we talked about it in the Q1, right? If you go back a year, We are having challenges hiring people in Germany and we end up having to raise labor rates and we hired like 100 people in the last 6 months of Q4 and Q1, so we are fully staffed. We are we got a brand new facility. It's Operating on all cylinders.

Speaker 2

We delivered 100 our operations team delivered 100% of what we asked them to. We have full consignment. We have full inventory. And that was frankly the rate limiting factor for us. We only grew 8% or 9% in the Q1 and I told you back then, watch what happens when the supply kicks in.

Speaker 2

And we grew 19% in the 2nd quarter and 22% in the 3rd quarter. So, we are well positioned and what's driving the revenue is Products, right. We've got some great new products and a great sales team and we expect to keep doing more of the same. It's a very proprietary portfolio in the fastest Growing segments of the Stankraft market. So again, we're very, very bullish on that technology continuing to grow.

Speaker 6

Okay. Yes, great. That's helpful. And then I guess just one more. You guys laid out the EBITDA expectations For this year in 2024, I'm talking a lot about operating leverage, but I was wondering if you could maybe get into Any potential gross margin expansion, I see it in the slide deck.

Speaker 6

I guess the question essentially is, How much gross margin expansion? Is it more just back to some of the historic levels? Did you guys think you can go beyond that into the Even the higher 60s, 68, 69?

Speaker 2

Yes. So we are given I mean, We keep commenting back to this investor presentation that we did almost it was in March of 'twenty two, so 18 months, 19 months ago, where we talked about we're going to we committed at that point to double digit top line growth And to $75,000,000 of EBITDA in 2024. We're not giving I'm not giving revenue guidance for 2024. I mean, the 75% is pretty much where we're at on the EBITDA. So but as far as gross margin, I mean, we've had to swallow a lot on the inflation side between Materials going up between labor rates going up.

Speaker 2

So it's really not going to be driven by margin increases next year. Now we're going to be working to get them up, But it's not really a margin driven thing. It's really a top line revenue, as well as Some really nice performance in some of our product lines above what we originally thought they were going to do, where we have very strong positions. And also I think there are some pricing opportunities, but I'm just not I'm not giving gross margin details yet. We're not that far along in our planning process to give out 2024 gross margin.

Speaker 6

Sure. Okay. That's fair enough. Well, congratulations on the quarter and continued progress to you guys.

Speaker 2

Thank you.

Operator

Thank you. And we'll take our next question from Frank Tanquilin from Lake Street Capital. Please go ahead. Great.

Speaker 7

Thanks for taking the questions. I wanted to follow-up on the double digit growth guidance you've put out there, Pat. I think it's been talked about in a couple of different I wanted to ask a little bit more specifically on growth by product line. I know throughout the Investor Day, it's stents leading the way, then On X and then Preservation and BioGlue in the single digits or lower single digits range. It feels like you add all that up and we can make 10% Relatively easily achievable, if I can say that.

Speaker 7

Maybe it's downplaying it too much, but just was hoping you could kind of walk through That thought process and how you think about growth from each line item in 2024?

Speaker 2

Yes. No, it's a good question, Frank. So I think the difference is from if you go back to that Investor Day, we basically said we thought we could grow Stenkraft 15 to 20. I think that holds. We've been up at the upper end of that range of late.

Speaker 2

We said On X should grow 10% to 15%. We've been at the upper end of that range of late. BioGlue, we said it was kind of a low single digit item. It was a little off this quarter because of what Ashley commented on. It wasn't anything material.

Speaker 2

It was because of the derogations last year. I think that still holds. I think the big difference is we said kind of like 5% to 7% on tissue. I think that's where there's upside Because of some of the things this Ross procedure, which is a great operation in patients under 60 for their aortic valve, The data that's come out on that is phenomenal and there's just a huge growth in that operation in all the major aortic cardiac centers. And we've this year, it's been more we've benefited more on the pricing side, but we've put things in place to significantly enhance our production and to meet the demands of that growth.

Speaker 2

So we expect that to be a major contributor. I think that's the one segment that's going to go up from

Speaker 7

And then maybe on Onex more specifically, we've talked about this market in the past, but I think it's been at least a couple of quarters since We've talked about the entire mechanical aortic valve market. Clearly, you continue to take share outpacing market growth. Can you maybe just talk a little bit where the market stands today and kind of how much more market you think is available to take and then how that's going to Compared to market growth or pricing increases over time?

Speaker 2

Yes. So the worldwide mechanical valve It is around $250,000,000 It's not perfect data, I mean, because it gets loose when you get outside the U. S. And Europe. It's about a $250,000,000 market for aortic and mitral.

Speaker 2

And depending on where you are in the world, like so for our for example, our market share in the U. S. Aortic It's probably over 60 at this point. So we still got 40 more to go. It's lower in Europe and it's way lower as you get outside the U.

Speaker 2

S. So We've got lots of room to grow internationally as well as in Europe. And the data that we've got out right now clearly It's a catalyst for continued Onex growth going forward.

Speaker 7

Perfect. And then maybe for the last one, just for Ashley. If you could talk about free cash flow, you guys have put a couple of quarters together in a row now with good cash generation, balance sheet looks better each quarter. So maybe talk about Anything you're comfortable sharing about free cash flow expectations on a go forward basis?

Speaker 3

Yes. Pat has mentioned this a couple of times. We We're going to give out our formal 2024 guidance in February of next year. We did have a second A quarter of really strong free cash flow generation. And we've done a lot of things internally to focus on that, whether it's Expense control or better working capital management, it's something that we're laser focused on.

Speaker 3

I made the comment In the call that we are now free cash flow positive on a trailing 12 month basis, And we expect that we will be free cash flow positive on a trailing 12 month basis going forward, and we expect that to improve Each quarter as we move forward.

Speaker 4

Perfect. I'll stop there. Appreciate taking the questions and congrats on a solid quarter. Thanks Frank.

Operator

And we'll take our next question from Jeffrey Cohen from Ladenburg Thalmann. Please go ahead.

Speaker 8

Just a couple of short ones from our side as you've addressed many of the issues. So was there an update? I heard a quick mention about Per call, was there an update as far as manufacturing over the past quarter and what that looks like on your end from manufacturing and transferring that

Speaker 2

Yes. So we basically just as a refresher, so we're currently producing per clot for Baxter. They've done a very nice job with the product and kind of meeting exactly where we thought they would be. We basically We don't have perfect information, Jeff, on this, but it looks like we will be producing per clot for them all of 'twenty four and maybe into the first half of twenty twenty five. And again, it will depend on how their transfer goes and we'll have I think as we get closer, we'll have better data.

Speaker 2

But I think for we're expecting to have it in all of 'twenty four, and then we'll know more kind of mid to late 'twenty four how their transfer is looking. So That's about as good as I can do for right now.

Speaker 8

Thanks. That's helpful. And then secondly, could you talk a little bit about Your commercial channels, at least ex U. S, as far as some of the territories that went from Direct to distributors. And will any of those be moving in the near future?

Speaker 8

Is this something on your to do list as far as some of the territories moving Either direction.

Speaker 2

Yes. So we've had a as you know, we've had a pretty deliberate strategy over the last 5 years To build out our channels in Asia Pacific and Latin America, I mean, when I joined the company 9 years ago, we had one person in Asia and nobody in Latin America. Now we've got probably a team of 25 in Asia and half probably a dozen people in Latin America. We're going to basically for 2024, we're going to slow down the investment there. I think we've got good infrastructure.

Speaker 2

There's more to do, but we're not doing in 2024. I think we've invested what we need to invest for where we are as a company. We did for example, we went direct in Greece this past year, kind of in our European region. And We'll look to do those things from time to time, but not in 2024. So we're kind of our channel we've got about 185 direct reps right now around the world and we're kind of Fixed there for next year and that's part of the why you're going to see the EBITDA drop through, because we're not going to be investing in further channel expansion next year.

Speaker 8

Okay, perfect. That does it for us. Thanks for taking the questions.

Speaker 2

Thanks, Jeff.

Operator

Thank you. And that was our last question. I'd like to turn the floor back to Pat Mackin, President and CEO for closing remarks.

Speaker 2

Well, thanks for joining the call. And as you can tell, we're extremely positive about how things are going at the company. We've been raised every quarter. We had a great Q3. We kind of were hitting on all cylinders.

Speaker 2

We've got great new data. Our factories are firing on all cylinders. We're delivering the numbers we told you we would deliver And we feel very confident about our ability to deliver double digit growth next year with $75,000,000 of EBITDA. So Look forward to next quarter and we'll be giving out our 2024 guidance. So thanks for joining.

Operator

Thank you. Ladies and gentlemen, this does conclude today's teleconference. We thank you for your participation. You may disconnect your lines at this time and have a great day.

Powered by Quartr
Earnings Conference Call
Artivion Q3 2023
00:00 / 00:00