Q1 2022 Artivion Inc Earnings Call
Greetings and welcome to the Art's Vivian first quarter 2022 financial conference call.
At this time all participants are in a listen only mode.
A brief question and answer session will follow the foil presentation. If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad.
As a reminder, this conference is being recorded I will now turn the call over to Brian Johnston from the Gilmartin group. Thank you you may begin.
Thanks, operator, good afternoon, and thank you for joining the call today, joining me today from <unk> management team are Pat Mackin, CEO and actually 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.
<unk> made on this call that look forward in time involve risks and uncertainties that are forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995. The forward looking statements include statements made as to the Companys or managements intentions hopes beliefs expectations or predictions of the future. These forward looking statements are subject to a number of risks uncertainties estimates and assumptions.
<unk> that may cause actual results to differ materially from these forward looking statements additional information concerning certain risks uncertainties that may impact. These forward looking statements is contained from time to time in the Companys SEC filings and in the press release that was issued earlier today now I'll turn it over to <unk> CEO Pat Mackin.
Hey, Thanks, Brian .
I'm pleased to report after an exceptional performance in the fourth quarter of last year, we followed up with a very strong first quarter. This year.
Constant currency currency revenue growth was 11, 2% compared to Q1 of 2021 display.
Despite substantial COVID-19 headwinds in the first half of the quarter.
This is our second consecutive quarter of double digit constant currency revenue growth.
Our growth in Q1 was driven by our aortic stent grafts on X mechanical valves and tissue processing.
More specifically on a constant currency basis, comparing Q1 of 'twenty two to Q1 of 'twenty, one stent grafts grew 34%.
<unk> on X and tissue processing, both grew 11%.
As many of you know, we held an analyst and Investor Day on March 23rd in New York City.
If youre not able to attend I would encourage you to listen to the webcast replay.
We provided a detailed overview of our goals and our strategy for the next three years. We also had kols share their experience using our products and.
And had members of our leadership team provide you with a review of our products and pipeline.
It was an excellent event and a great way to understand why we are so excited about the future of the company.
We announced three key growth initiatives that we will focus on over the next three years to drive double digit constant currency revenue growth <unk>.
They are as follows first we will continue to drive growth in on X and our Arctic stent grafts.
Second we will generate further upside from our investments in our channels and our new regulatory approvals in Asia Pacific and Latin America.
And third in 2022, we will drive further growth through our PMA approvals in the U S for <unk> and the on X product mitral low INR indication.
This quarter, we made solid progress in each of these initiatives. So let me take a few minutes to review them.
Starting with our stent graft offerings revenue in the first quarter increased 34% on a constant currency basis compared to the first quarter of last year building on our performance in Q4, where we posted 30, 33% year over year growth in stent grafts.
We had particular strength in our Vito open neo frozen elephant trunk product as well as MBS.
For on X, we posted 11% constant currency revenue growth in the first quarter of 'twenty, two compared to the first quarter of last year.
In the fourth quarter of 2021, where we posted 13% year over year growth compared to the fourth quarter of 2020.
We anticipate demand for these products will continue to build as adoption improves in hospital staffing shortage abate.
We believe that we are only beginning to see the full potential of our portfolio and environment not significantly hampered by the effects of the pandemic.
Moving on to our next initiatives International expansion in Asia Pacific and Latin America through new regulatory approvals and commercial footprint expansion.
I am pleased to report that we are executing very well on the strategy as demonstrated by first quarter constant currency revenue growth of 39% in Asia Pacific and 93% Latin America.
We continue to expect these regions to be important contributors to our growth over the coming years as we continue to execute on this strategy.
Regarding our third initiative continued to make progress on achieving regulatory approvals for on X mitral and per club.
First is our application in the U S for a lower INR label for the on X mitral valve, which we will which we believe will be significant for clinic, a significant clinical benefit for patients.
We are in active dialogue with the FDA and continue to expect to receive PMA approval for the lower INR label for the on X mitral valve just like our low INR label for the Onyx aortic valve sometime in 2022.
If approved we believe will take significant market share in the U S with on X mitral valve just as we've done and continue to do so the on X aortic valve.
For <unk>, we continue to work closely with the FDA and expect to receive approval during the second half of 2022.
If approved we will receive a $25 million milestone payment due to us under the divestiture agreement, we have with Baxter and we will begin to supply per cluster Baxter generate revenue for approximately two years thereafter.
In addition to our progress. These three initiatives. We also continue to make strides on our midterm pipeline with key products currently in U S clinical trials and others about to start later this year.
These three products our proactive <unk> next.
Nexus and AMD.
We continue to make significant enrollment progress and proactive.
Which is our prospective randomized clinical trial to determine if patients with the on X aortic valves can be maintained safely and effectively on <unk> versus warfarin.
We currently have enrolled 698 patients so far in the study and feedback from surgeons and patients patients participating trial remained very positive.
We anticipate completing the enrollment in this trial around the end of the third quarter of 2022 and assuming the trial meets its endpoints. We believe we can achieve FDA approval for this new indication by early 2025.
If approved by the FDA, we believe the on X aortic valve using <unk> rather than warfarin.
Should become the market, leading valve aortic valve in the market for patients under the age of 70, given the significant benefits to patients of using <unk> rather in warfarin.
As for Andas, We recently received FDA approval to begin our pivotal clinical trial called persevere.
Persevered trial as a non randomized clinical trial at up to 25 sites in the U S and which we expect to enroll around 100 patients.
These patients will experience acute type aortic dissections.
The combined primary efficacy and safety endpoints of the trial are as follows reduction in all cause mortality new.
New disability disability stroke.
Myocardial infarction, and new onset renal failure, requiring dialysis as well as the expansion of the two aluminum aorta.
We anticipate enrolling the first patient this month and completing full enrollment by the end of the year.
Following a one year follow up period, we anticipate we will receive FDA approval for Mds in early 2025.
In addition.
Turn to the progress we've made on production of Mds. We're also pleased to report that our partner Endo span is making progress on its U S. IDE trial for <unk> known as <unk>.
There are approximately 19 patients that have been currently been treated as well as up to 24, who have been approved for treatment.
<unk> is currently estimating the completion of the trial in September of 2023.
They likely leading to a PMA approval in Q2 of 2025.
Yes.
If each of these three trials proceed as we anticipate and we get FDA approval for <unk>.
Andas in excess in 2025, this would increase our addressable market opportunity by an estimate of $1 3 billion.
With that I'll now turn the call over to Ashley.
Thanks, Ted and good afternoon, everyone.
<unk> revenues were $77 2 million for the first quarter up eight 6% on a GAAP basis, and up 11, 2% on a constant currency basis, both compared to Q1 of 2021.
Revenues benefited from strength in aortic stent grafts onyx in cardiac tissues.
On a year over year basis in the first quarter of 2022 aortic stent graft revenues increased 26%, reflecting increased procedure volumes and revenues from our new product launches.
On X revenues increased 10% and tissue processing revenues increased 11%, reflecting improving procedure volumes relative to the first quarter of 2021.
<unk> revenues decreased 12%, reflecting lower procedure volume in the U S. In the first half of the quarter due primarily to hospital staffing shortages.
On a constant currency basis compared to the first quarter of 2021 aortic stent graft revenues increased 34% on X and tissue processing revenues, both increased to 11% and <unk> revenues decreased 11%.
On a regional basis first quarter 2022 revenues in EMEA increased 5% Asia Pacific increased 38% Latin America increased 88% in North America increased 4% all compared to the first quarter of 2021.
On a constant currency basis revenues in Europe increased 12% Asia Pacific increased 39%.
Latin America increased 93% and North America increased 4% all compared to the first quarter of 2021.
Gross margins were 65, 7% in Q1 compared to 67, 3% for the first quarter of 2021. The decrease was driven primarily by product mix within our aortic stent graft line and <unk> being a smaller portion of our revenues.
G&A expenses in the first quarter were $39 million compared to $38 6 million in the first quarter of 2021.
Excluding nonrecurring acquisition related and business development benefit of $1 6 million in 2022, which.
Which primarily consist of a noncash $1 8 million benefit related to fair value adjustments for Cyrus contingent consideration and re branding charges of $883000.
And then excluding nonrecurring acquisition and business development charges of $1 5 million in 2021.
G&A expenses were $39 7 million for the first quarter of <unk> 22, compared to $37 2 million in the first quarter of 'twenty one.
On the bottom line, we reported GAAP net loss of $3 4 million or <unk> <unk> per fully diluted share in the first quarter.
non-GAAP net income was $1 1 million or <unk> <unk> per share in the first quarter.
As of March 31, 2022, we had approximately $51 million in cash $317 million in debt and a full $30 million available under our revolving credit facility.
Adjusted EBITDA for the first quarter of 2002 was $10 million compared to $11 4 million for the first quarter of 'twenty one.
Please refer to our press release for additional information about our non-GAAP results, including a reconciliation of those results to our GAAP results.
And now for our 2022 outlook. We expect we continue to expect constant currency revenue growth of between nine and 11% for the full year of <unk> 22 compared to 21.
In our last call. We stated that we faced a $6 million currency headwind in 'twenty two versus 21.
Since that time. The dollar has continued to strengthen resulting in additional FX headwinds of approximately $2 million.
Considering this we anticipate full year revenues will now be in a range of $317 million to $323 million for the full year.
Though we want to be clear that we will not be issuing quarterly guidance going forward. We felt it would be best to provide a little more information on what we see for the second quarter.
Given our assumption of a euro USD.
<unk> rate of 1.08 for the second quarter.
Our prior year Q2, 2021, adjusted revenue is $73 6 million.
Which accounts for an anticipated $2.
$2 $4 million currency headwind.
As we have previously communicated since our notified body for bio glue exited the market in 2019, we received an extension for our CE Mark until December 31 2021.
Due to Covid related travel restrictions, our new notified body was unable to complete the recertification process by that time.
We will now not be able to re certified bio glue until Q3 of this year.
As we have previously indicated we have been seeking derogations in certain EU countries pending recertification, but that process too has been delayed by factors beyond our control.
As a result.
<unk> revenues in the second quarter could be adversely affected by up to $3 million.
If revenues are affected by $3 million constant currency growth in the second quarter will be in the range of 4% to 6%.
Not for this temporary delay in bio glue recertification.
<unk> constant currency revenue growth would be in a range of 8% to 10%.
Despite the delays in Q2, and a similar $3 million headwind potential headwind in Q3, we still expect full year constant currency revenue growth in the range of between nine and 11%.
If we receive additional derogations the impact to Q2 and Q3 could be significantly less.
Our guidance assumes no other significant impact from Covid during the remainder of this year and a return to a more normal operating environment, meaning limited deferred surgeries and staff shortages and more and selling in person selling.
We believe that we can comfortably continue to invest in our commercial channels in Asia Pacific and Latin America, our R&D pipeline and service our debt without having to raise any additional capital with that I'll turn it back over to Pat for his closing comments.
Thanks, Ashley so to summarize our goal is to become a world leader in aortic repair through innovation.
We firmly believe we have the necessary pieces in place to deliver on that growth on these growth initiatives, we laid out in our Investor day.
We have made key acquisitions in the past few years and it provided us with products in our pipeline to deliver solid revenue growth for years to come.
Our direct sales channel is broad and expanding with.
We've invested in manufacturing and a significantly increase our manufacturing capacity.
And the next three years, we expect to grow double digits and become a $400 million business.
We also anticipate 200 basis points.
200 basis point increase in our gross margin, we expect to generate $75 million to $80 million and adjusted EBITDA, while reducing our net leverage to less than three times.
Our first quarter, we had.
Our first successful quarter that moves us much closer to delivering on these metrics first we saw a 34% constant currency growth in our erotic stent graft portfolio and 11% growth in our on X and tissue processing portfolios.
Second we posted 93% constant currency growth in Latin America, and 39% growth in Asia Pacific.
And we're continuing to invest in these regions.
Third in 2022, we expect to receive PMA approvals for <unk> as well as on X product mitral low INR.
And we have a robust mid term pipeline of three U S clinical trials, either enrolling or about to start enrolling.
These trials proactive.
<unk> and <unk> persevere should expand our total addressable market by $1 3 billion.
In late 'twenty early 'twenty five.
In closing our business momentum is strong we believe that we have the strategy the products and the team in place to continue that trend for the stable for the foreseeable future.
For your time continued interest and activity on operator, please open the line for questions.
Thank you we will now be conducting a question and answer session.
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One moment, please always call for your questions.
Our first question comes from the line of Rick Wise with Stifel. Please proceed with your question.
Hi, good afternoon, Pat and.
Great to see the solid progress in the quarter.
Maybe to start off with.
Just to start somewhere.
Cutoff with the Onyx performance another solid quarter from Onyx as you know we did some Dr. Due diligence.
Work and I for one came away impressed that the docs are.
Really if you like.
This is an important product they're going to use it more they're focused on a lower INR and.
Engineering development and hearing is competitively differentiated so just reflecting all of that how are you. What are the next steps in getting the message out on Onyx.
And maybe just as part of that discussion.
How does how do the <unk>.
How does the Pro Act.
Mitral.
<unk> play into that or complement what you're already doing on the.
Aortic side.
Yes, thanks, Rick so.
So I think.
The things are interesting about Onyx is that this is Ben.
We acquired that company.
Almost six years ago.
And with the proactive aortic, which is the first ever low INR approval by the FDA in the mechanical valve segment.
We've taken like 30 points of market share against some big competitors.
Our sales force at that time, when we launched that product had been selling.
Tissue valves aortic and pulmonary tissue valves and they had not had experience in the mechanical segment.
And so <unk> got six years of experience not only selling the aortic low INR, but also building relationships with all of the cardiac surgeons in the U S as well as in Europe and Asia.
Who implant part.
Heart valves, whether it's an aortic and mitral theyre the same group so I think that the.
The proxy using.
The proactive aortic as a surrogate for what we're going to do with the <unk> mitral is a good one because we've got a highly trained sales force.
<unk> mitral valves are on the shelves of lots of hospitals. Once we get this label change customers are used to a lower INR.
For a valve like the on X aortic so the transition I think will be easier.
I also think that as we.
Talked about it at our Investor day, the the mitral position is a is a low pressure of al situation, which requires a higher IRR. So that any reduction from the standard of care is even more meaningful for the patient and their lifestyle.
And then I think the third is obviously, we were almost 700 patients enrolled in <unk> and obviously that we are.
We're not marketing that from a commercial standpoint, but we've got 60 centers involved in that trial. So I think the combination of.
The Onyx proactive Arctic continued adoption.
Pending on X mitral approval and we plan on completing enrollment in the proactive trial here in the next quarter or so I think the three of those really kind of highlight the brand of Onyx and the technology around that brand and that we do things differently with that brand because of the technology, we can run at lower <unk>.
And we're also testing it.
And a massive clinical trial to see if we can prove that you can use <unk> going forward with the real game changing technology. So I think.
Honestly is just continuing to roll and we had another great quarter in <unk>.
Look for more of the same look forward the mitral approval later this year.
Great.
And.
Can you.
Talk.
On the other side darker side of the world.
<unk> bio glue.
Delayed research.
I'd be curious to hear.
What steps you can take to if there are any to help accelerate this and resolve it I appreciate youre being very clear.
Great to understand it but.
I'd be curious to hear I mean.
Is there anything that you can do as a company to push this forward and what our next help maybe help us understand what our next steps.
Okay.
Yes, thanks, Rick So I mean this is al.
This is very frustrating and this has got nothing to do with the product's safety performance.
There is still great demand for the product. This is frankly, a regulatory administrative issue.
That was triggered by our previous notified body for <unk> decided once these new MTR regulations came out.
They thought it was too big of a burden and they didn't want to do it. So they just got out which meant we had to find a new notified body well in advance of when MBR goes into full effect, which is in may of 2024, which left us having to go find a new notified body and we've done that and in the process of doing the recertification.
Which was supposed to happen they have to do a site visit they're supposed to come to our facility here in Atlanta last fall, which would have put us in plenty of time to get the approval by the end of the year.
They literally delayed because of Covid travel restrictions.
So now theyre not come until June .
<unk> gone through this derogation process, which nobody has ever done before because nobody's ever needed to do it.
And it's taken a lot longer and we've been successful in some places we have some other big countries that are in the wings I think one of the things that we wanted to be transparent about the situation. The numbers had actually talked about are kind of the worst case for baidu.
We have a couple of big countries in the works right now that could come through but theyre going through government agencies. So I have really very little control.
We're also going for a European wide derogation, which again.
Does not happen frequently because no one's ever been in a situation before where there are other companies that are dealing with this.
So I mean this is this is a transient issue. It's got really nothing to do with the business. This product has got almost 3 million units implanted around the world. It's approved in Japan. It's approved in the U S. We have no safety issues with the product.
We're shipping and selling everywhere else, it's got nothing to do with manufacturing. It's frankly, it administrative regulatory thing that people can travel to inspect our site because of Covid.
We offered a fly them on a private jet and they don't want to do that so I mean, we're doing everything we can.
<unk> been working at this for a while but it is what it is and as soon as we get our inspection done in June .
We're kind of at the Mercy of how long it takes the notified body. So we expect probably in Q3. Some time, we will be back and we'll be back in business. So that's kind of the full picture on that situation.
I appreciate it thanks, so much.
Thanks, Rick Thank you.
Thank you once again as a reminder, if you would like to ask a question. Please press star one on your telephone keypad. Our next question comes from the line of Suraj Kalia with Oppenheimer. Please proceed with your question.
Yes.
Hey, Pat Ashley can you hear me alright.
Yeah, Hey, Suraj.
Perfect.
Congrats on a great quarter.
If memory serves me right. This is the first quarter.
International sales were greater than domestic sales. Please correct me if I'm wrong.
And I'm curious did our FX headwinds right you referenced that at your analyst day about a month or so ago.
At 1.13 for the Euro.
Latin America doubled almost in the quarter.
Walk us through what are the drivers and more importantly.
<unk> do you see this.
Yes, yes, thanks Raj So I think it's a couple of years one of the things Thats interesting about this business as we've talked before I mean, we're very different than a lot of companies of our size and that many companies of our size have mostly U S.
A couple of products, mostly in the U S. We have.
Many different products and we're in 100 countries. So we're very diversified for our products and we're very diversified for our channels.
What happened this quarter is as you well know the first half of Q1.
U S staffing and hospitals was a real issue I know you are hearing from all your calls right. So we are seeing real issues with hospital staffing it wasn't patients clogging up the ICU with Covid. It was really the the hospital SaaS getting SaaS getting infected and not being able to work. So what happened was you.
We saw a kind of a shortfall in bio glue and vascular tissue in the first quarter were really out of the U S and that was the difference between us even growing 15%.
Simultaneously, we saw recoveries from Covid in Latin America, and Asia Pacific, but we've been talking about this investment in Asia Pacific Latin America for a while now.
It's a pretty simple process right, we get new approvals.
For all the products, we have in our portfolio and then we hire salespeople and they go to work and.
What we've said at the analyst day, we're expecting 25% to 30% growth in Asia Pacific and Latin America for the next three years.
We obviously had.
Big quarter, and both right out of the blocks.
And then our European business as you know has got all of our new stent graft technology.
They're doing extremely well with neo with our branch silicone Domino and side with AMD.
So I guess I was just kind of a multiple different pieces, depending on the geographies, but clearly we expected to see.
Faster growth outside the U S. We didn't expect to see the U S being off like they were but we also didn't know omnicom was going to be as Berlin.
Staffing standpoint can have such a big impact in the first half of the quarter.
Right, Okay fair enough I think Pat a multi layered question.
So.
On on X right, how should we think about U S versus U S contribution in the quarter.
Windows for proactive many winners remind us the DSM be whats going to meet to me forgive me. The many quotes going on maybe you referenced that's already as to when you'll expect to be SMB to meet this month and also Pat if I could just throw in.
<unk>.
Given the mitral on X mitral PMA approval status gentlemen, congrats and thank you for taking my questions.
Okay. I'll go one at a time I think similar similar to on the first one about onyx.
U S O U S.
Again, the U S <unk>.
Staffing issues caused an X to be lighter than normal still.
Still we did okay with it but we had way better growth outside the U S. Because we didn't have the staffing issue. So.
That was not normal, but it's not it's not a surprise given what happened in the first half of the quarter here in the U S.
<unk>.
They meet every six months I believe at the end of May.
We don't put out press releases on this kind of stuff, but I think it's going to be the end of may end of this month.
And then.
<unk> mitral.
We're expecting approval probably in the second half of this year, we're working with the FDA.
Real time on both of those both of those PMA product mitral as well as per clock. So.
We're excited about the about the.
Opportunity to have the sister valve to the COACT aortic.
And our teams are Raring to go so we're just waiting for the approval and again I think it's probably give you more of a second half of the collect mitral.
Thank you.
Thanks, Ron.
Mr. Mackin there are no further questions at this time I would like to turn floor back over to management for any closing remarks.
Well, thanks for joining and we appreciate your time as you said it was.
At the Investor day, we laid out kind of a clear plan for the next three years and you can kind of measure our progress and we told you we're going to grow our focused products Onyx and.
Extensive stent grafts.
Extensive stent grafts in the high teens to 20%. We grew 34, we told you we're going to grow on X, 10% to mid teens, we grew 11%.
You're going to grow the overall business.
Nine to 11 this year, we grew 11%.
We told you that Asia Pacific and Latin America should grow at $25 to $30.
They grew 39 93, respectively Asia Pacific and Latin America.
Should we get <unk> approved and we're tracking towards both per Claude and collect mitral in the second half of this year and we're our midterm pipeline of <unk>.
<unk>.
The Nexus turnarounds in the AMD persevere, we expect to enroll productivity, we expect to enroll persevere and we expect to have big improvement in the.
Nexus enrollment so we pretty much checked all the boxes.
Even in even in the face of challenges like Amazon here in the U S. So we appreciate your support and look forward to getting back with you next quarter. Thank you.
Thank you. This concludes today's teleconference. You may disconnect. Your lines at this time. Thank you for your participation and have a wonderful day.
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