Artivion - Q2 2023

Transcript

Operator (participant)

Greetings, welcome to the Artivion second quarter 2023 financial conference call. At this time, all participants are in a listen-only mode. A brief Q&A session will follow the formal presentation. If anyone should require operator assistance during the conference, please press *0 on your telephone keypad. As a reminder, this conference is being recorded. I will now turn the call over to Laine Morgan from Gilmartin Group. Thank you. You may begin.

Laine Morgan (Associate VP)

Thank you, operator. Good afternoon, and thank you for joining the call today. Joining me today from Artivion 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. The forward-looking statements include statements made as to the company's or management intentions, hopes, beliefs, expectations, or predictions of the future. These forward-looking statements are subject to a number of risks, uncertainties, estimates, and assumptions that may cause actual results to differ materially from 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. Now I'll turn it over to Artivion CEO, Pat Mackin.

Pat Mackin (CEO)

Thanks, Laine, and good afternoon, everybody. The second quarter of 2023 was an outstanding quarter for Artivion, both commercially and operationally. I'm pleased to report we delivered constant currency revenue growth of 11% year-over-year, resulting in a record $89.3 million in quarterly revenue. Our strong performance was led by improved revenue growth in our stent graft business, which increased 19%, followed by On-X at 11%, tissue processing at 9%, and BioGlue was up 4%. These were all compared to the second quarter of 2022 on a constant currency basis. We also received FDA approval for PerClot during the quarter and commenced shipping PerClot to Baxter.

We continue to execute on our strategy to drive increased revenue with existing markets, as well as new geographies through expansion of our commercial footprint with new regulatory approvals, and by expanding our adjustable markets through our clinical pipeline. Our strong top-line performance led to $13.8 million in non-GAAP adjusted EBITDA in the second quarter. This is a 35% increase compared to the second quarter of last year. We expect our strong momentum in the first half of the year to continue into the remainder of the year and through 2024. We were confident coming into 2023 that our business was well positioned for success, and the year is unfolding largely as expected.

At our Investor Day in March 2022, we committed to delivering compounded annual growth of double-digit constant currency revenue growth through 2024, through driving further operating leverage, adjusted EBITDA to $75 million in 2024. We believe we remain on track to achieve both of these goals. Our commercial team is also executing extremely well. As I mentioned earlier, stent graft revenues were up 19% constant currency versus the second quarter of last year. We saw double-digit constant currency year-over-year growth in stent grafts across all geographies, fueled in part by increased stent graft production as a result of recent production hires in Germany and strong performance in AMDS and NEXUS. We anticipate demand to remain strong in 2023 and beyond for our stent graft products should see continued sustained revenue performance. Additionally, On-X increased revenue 11%.

We continue to take market share globally, as we're the only mechanical aortic heart valve that can be maintained at an INR of 1.5 to 2.0. We believe our valve is the best aortic valve in the market, leading market share gains each year. We are also executing well on our initiative to grow product sales in APAC and Latin America through our new regulatory approvals and commercial footprint expansion. In APAC and Latin America, we delivered second quarter constant currency revenue growth of 23% and 24%, respectively, compared to the prior year period. We continue to expect these regions to be important growth drivers over the coming years as we continue to leverage our industry-leading portfolio of these regions and going forward.

On the regulatory front, as I mentioned earlier, in May, we received FDA approval for PerClot and began shipping PerClot to Baxter. As for PROACT Mitral, we are in continued discussions with the FDA. We've not factored any potential regulatory approval into our forecast for 2023 and beyond. In addition to our progress on each of these three initiatives, we continue to make good progress on the AMDS clinical trial. We've enrolled 75 patients in the PERSEVERE trial. This is our IDE clinical trial for U.S. PMA approval in up to 30 centers and approximately 100 patients who have experienced acute Type A aortic dissection. The combined primary efficacy and safety endpoints for the trial are a reduction in all-cause mortality, stroke, heart attack, and new onset of renal failure requiring dialysis. The efficacy endpoint is the expansion of the true lumen of the aorta.

We anticipate completing full enrollment in PERSEVERE in the coming months, likely before the end of the third quarter. Following a one-year follow-up period, assuming the trial meets its endpoints, we anticipate we should receive FDA approval for AMDS in 2025. Our partner Endospan, is making progress on the U.S. IDE TRIOMPHE for its NEXUS Aortic Arch Stent Graft System. In that trial, there are approximately 34 patients enrolled and treated out of a total of 60 patients enrolled and approved for treatment. Endospan estimates enrollment completion later in 2023, and a PMA approval in 2025. Assuming trial endpoints are met and no FDA panel is required. To reiterate, if these PMA trials are proceed as anticipated, we expect FDA approval for AMDS and NEXUS in 2025.

At that time, assuming we exercise the option for Endospan, these, these two products would significantly increase our addressable market opportunity. With that, I'll now turn the call over to Ashley.

Ashley Lee (CFO)

Thanks, Pat. Good afternoon, everyone. Total revenues were $89.3 million for the second quarter of 2023, up 11% on both a GAAP basis and constant currency basis, both compared to Q2 of 2022. Non-GAAP adjusted EBITDA increased 35% from $10.3 million in the second quarter of 2022 to $13.8 million in the second quarter of 2023. On a year-over-year basis, in the second quarter of 2023, stent graft revenues increased 19%, On-X revenues increased 10%, tissue processing revenues increased 9%, and BioGlue increased 4%. On a constant currency basis compared to the second quarter of 2022, stent graft revenues grew 19%, On-X revenues grew 11%, tissue processing revenues increased 9%, and BioGlue revenues increased 4%.

On a regional basis, second quarter 2023 revenues in Asia Pacific increased 23%, Latin America increased 21%, North America increased 8%, and EMEA increased 12%, all compared to the second quarter of 2022. On a constant currency basis, revenues in Asia Pacific increased 23%, Latin America increased 24%, North America increased 8%, and EMEA increased 11%, all compared to the second quarter of 2022. Gross margins improved to 65.1% in the second quarter, an increase compared to both the first quarter of 2023 and the second quarter of 2022. The increase was driven by price increases in product mix, partially offset by inflationary impacts on materials and labor. G&A expenses in the second quarter were $57.2 million, compared to $39 million in the second quarter of 2022.

Excluding nonrecurring acquisition-related business development expenses and benefits and other nonrecurring charges, G&A expenses were $45.9 million for the second quarter of 2023, compared to $41.8 million in the second quarter of 2022. R&D expenses for the second quarter were $7.4 million, compared to $8.6 million in the second quarter of 2022. The decrease in R&D spending resulted primarily from the cessation of the PROACT-NA trial last September. Other income and expenses of $10.3 million includes $6.1 million in net interest expense, a $5 million charge related to the final payment to Endospan pursuant to our loan agreement with them, and foreign currency translation gains of approximately $800,000.

On the bottom line, we reported GAAP net loss of approximately $3.4 million, or $0.08 per fully diluted share in the second quarter of 2023. Net loss for the second quarter of 2023 includes pre-tax charges of $10.9 million related to contingent consideration for the acquisition of AMDS and $5 million related to the final payment to Endospan, partially offset by a net pre-tax gain of $14.3 million related to our receipt of the PerClot PMA approval milestone payment and the impact of valuation allowances on our deferred tax assets. non-GAAP net income was $2.3 million, or $0.06 per share in the second quarter. non-GAAP income includes foreign currency gains and excludes business development and other nonrecurring charges.

As of June 30, 2023, we had approximately $49 million in cash, $313 million in debt, and the full $30 million 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. Now for our updated outlook for 2023. Given our momentum in the first half of 2023, our pricing initiatives, anticipated 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 10% and 12% for the full year of 2023, compared to the previous range of 9%-12%.

We expect revenues to be in a range of $342 million-$350 million, compared to our previous range of $337 million-$348 million. We continue to expect revenue growth will accelerate more meaningfully in the 2nd half of the year compared to the 1st half of the year, as recent hires in Germany become fully productive, as we continue to pursue price increases for products where we have clear clinical differentiation, and with the approval of PerClot. With our strong 2nd quarter performance, continued top line revenue growth, general expense management, and a decrease in R&D spending, we have increasing confidence that we will meet or exceed our adjusted EBITDA guidance of a minimum of $52+ million for 2023.

These factors will allow us to remain on track to meet our $75 million 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 2025. As we continue to execute on our strategy and drive EBITDA and free cash flow higher, and with an apparent near-term end to the Fed's interest rate increases, we believe our options to address our capital structure will continue to improve as we move throughout the year.

Finally, our term loan B contains no financial covenants that would place us in default unless we were to have more than $7.5 million drawn on our revolving credit facility at the end of any calendar quarter, which we do not. As of now, we have the full $30 million 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 affords us greater flexibility as we consider our future obligations and ways to increase shareholder value. With that, I'll turn the call back over to Pat for his closing comments.

Pat Mackin (CEO)

Hey, thanks, Ashley. As you just heard, a momentum that began in the 1st quarter continued into the 2nd quarter, capping off a very successful 1st half of the year. Our strategy is working and generating what we expected to be meaningful EBITDA growth this year. We also took guidance up for the 2nd straight quarter, and we're confident our strong growth in 2023 will continue for the following reasons. 1st, continued strong performance in our stent graft business, due principally to recent staffing improvements at our German manufacturing facility and other supply chain initiatives. 2, continued strong On-X performance, driving further market share gains. 3, continued strong performance in Asia Pacific and Latin America as a result of our investments and new regulatory approvals in those regions. 4th, growth in BioGlue and PerClot due to our recent regulatory approvals.

Fifth, we have two U.S. clinical trials, AMDS PERSEVERE and Endospan's NEXUS TRIOMPHE, that are currently enrolling. Combined, we expect to significantly expand our total addressable market in 2025, assuming we execute on the Endospan option. We continue to expect revenue to grow double digits as compared on an annual basis, and to generate greater than $75 million of adjusted EBITDA in 2024, which will reduce our net leverage to less than 3 times, despite the headwinds we face from inflation and its impact on gross margins. In conclusion, we continue to advance our goal of being a market leader in aortic repair and expect 2023 to be a standout year for the company. I want to thank all of our employees around the globe for delivering on an exceptional second quarter. With that, operator, we'd like to open the line for questions.

Operator (participant)

Thank you. We will now begin the Q&A session. To ask a question, you may press star then one on your touchtone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. Our first question comes from Rick Wise with Stifel. Please go ahead.

John Mark Rogers (Senior VP of Investments)

Hey, Pat. Hey, Ashley. This is actually John for Rick today. I wanted to start off on price. Last quarter, you spoke about implementing price increases in certain product areas. I was just curious how successful that implementation has been so far, any kind of benefit it might have contributed in the second quarter, and what your expectations are in the second half of the year?

Pat Mackin (CEO)

Yeah, we, we, we talked about looking at some of our products that were, you know, highly proprietary, with patented technology that really nobody else has, that also provide a significant benefit to patients. Given the demand on some of these products, chose to raise prices there, it's been very successful. I think as I mentioned in my comments, we expect to see you know more of that as we go throughout the year. A lot of those prices were, you know, rolling through the second quarter, and a lot of those will be in place fully for the third and fourth quarter. It's been, it's been kind of as we thought and been, been very well executed.

John Mark Rogers (Senior VP of Investments)

Great, great. Then to follow up on that, I'd like to look at it through the lens of revenue guidance for the year. If I just take the balance of the first and the second half, it implies almost a 50/50 split, a little more in the, the second half than the first. I'm just curious, with the price increases built in, could there be potential upside to that midpoint? Like, what's getting you to the higher end of the range? Is it, is it price? Can you just talk us through the factors there?

Pat Mackin (CEO)

Yeah, I mean, I think there's, there's, you know, we have a lot of levers we can pull. You know, we've got the, the price increases we just talked about. We've got the supply for our stent grafts that I mentioned in my comments that, you know, we've, we've done a great job in building up our inventory, which, if you look back in the first quarter, our stent grafts grew in kind of the 8% or 9% range, and they're growing 19 now. So we expect the, you know, the stent graft business to continue to, you know, grow faster. We also have some new product launches in there that are gonna kick in. We've got some stuff coming out of regulatory that'll kick in.

A lot of it, like, like any, any quarter, I mean, we've got projections for when we think stuff's gonna get approved, for when we think launches are gonna roll out, you know, and that's, that's really the difference. I mean, we're confident we can grow double digits. The question is, you know, if we grow, you know, 11, 12, you know, in the, in the range, is going to depend on how those things come together.

John Mark Rogers (Senior VP of Investments)

Got it. Thank you. That's very helpful.

Operator (participant)

Our next question comes from Suraj Kalia with Oppenheimer. Please go ahead.

Shaymus Contorno (Equity Research Associate)

Hi, Pat Mackin. Hi, Ashley Lee. This is Shaymus actually on for Suraj Kalia today. Congrats on the great quarter. Just kind of to start on our end, you know, looking at SG&A, it kind of jumped a, I'd say, a decent amount, about 64%, if my math is right. Just looking for any particular reason for that, if that's a continuation that we might see going forward? You know, can you just break it down a little, please?

Pat Mackin (CEO)

Yeah, I'll let Ashley take that one. It's not a real SG&A job.

Ashley Lee (CFO)

Yeah, the biggest contributor was the, big spike that we had in contingent, consideration for the AMDS acquisition. That was a non-cash charge of about $11 million. You know, I'd made some comments in our prepared remarks that, you know, excluding the, amounts that I just described, that adjusted SG&A came in at, around $45 million, roughly, compared to the previous year.

Pat Mackin (CEO)

Yeah, I mean, the way I look at this, I mean, that's an accounting gyration of an acquisition that we did. If I look at the pure operations of the company, we grew the top line 11%, and our operating expenses grew 5%.

Shaymus Contorno (Equity Research Associate)

Got it.

Ashley Lee (CFO)

Yeah.

Shaymus Contorno (Equity Research Associate)

Got it.

Ashley Lee (CFO)

Yeah, the, the true comparison is around a little over $45 to, to around $42 from the previous year.

Shaymus Contorno (Equity Research Associate)

Perfect. Thank you for that.

Ashley Lee (CFO)

Mm-hmm.

Shaymus Contorno (Equity Research Associate)

Just kind of thinking as well, you know, how should we kind of think of current On-X U.S. sites, average utilization rate, kind of what's, what's the room for growth there?

Pat Mackin (CEO)

Yeah. I mean, On-X is a, you know, plays in... We, we have obviously a, an aortic valve and a mitral valve. That's about a $250 million global market that we've been growing double digits since we acquired the company. You know, I'm not going to get into specifics. You can do the math on our numbers, but we still have plenty of room for growth. You know, we've seen some competitors exit because we've taken so much share in some geographies that they've decided to exit kind of in other places. We see upside really around the world for On-X. You know, we continue to put up double-digit growth. We've also had, you know, the mitral publication that's, you know, people are very interested in.

That's, you know, even a better valve than the than the aortic. I think with our global channel and our focus on the aorta, our relationships with customers and the, the, the strength of that product, we feel it's going to continue to kind of grow at the double digit range going forward.

Shaymus Contorno (Equity Research Associate)

Perfect. Perfect. Thanks for taking our questions.

Operator (participant)

Ladies and gentlemen, as a reminder, if you would like to ask a question, please press star one. Our next question comes from Frank Takkinen with Lake Street Capital Markets. Please go ahead.

Frank Takkinen (Senior Research Analyst of Medical Devices)

Great. Thanks for taking the questions. Congrats on the quarter. Wanted to start with one on stents. Pat, you alluded to it in your prepared remarks, but manufacturing has been a challenge. Clearly, that came back really solidly this quarter. Was hoping you could take us a little bit deeper into the status of that. Is there still work to be done, or are you feeling pretty confident with your current capacity? How should we be thinking about that line item through the back half of the year?

Pat Mackin (CEO)

Yes, if you, if you go back over the last couple of quarters, right? This is one that we've, we highlighted that, you know, Q1 are, are really our only kind of like, light performance was on our stent grafts, even though we hit the top line and the bottom line. And we talked about, you know, the, the reason for that is, you know, kind of in this inflationary period last year, we were having a hard time hiring people in, in our big facility in Germany, which is where we produce all of our stent grafts. We put a big, big initiative in place in the fourth quarter of last year, hired like, you know, 60, 70 people.

They were all hired in the fourth quarter, and then we told you last quarter that, you know, they had to get trained in the first quarter, which they've, they've done. We basically hit our production plan for the first half of the year. The team did a great job. We're very well positioned. We've got the people in place, they're producing, and we're, we're set up well for, for the second half and going into 2024 with the team that we've got there. I think that is, is largely behind us, and, like I said, the team's executed extremely well.

Frank Takkinen (Senior Research Analyst of Medical Devices)

Okay, that's helpful. Maybe one on On-X. Heard the comments on taking share. Was hoping you could maybe bring us a little bit deeper on if there's another factor in there of the market just returning to normal, and there's more market growth in that as well. I was hoping you could kind of parse out the growth there between share taking as well as any market dynamics that are occurring.

Pat Mackin (CEO)

Yeah. I, I think 1 thing that, I mean, if, if you saw, you know, 1 of the TAVR companies reported that their surgical business grew faster than their TAVR business, which is interesting. I, I do think that there is a, you know, a kind of a growth overall in the market, and we don't have, you know, great market data on that. I do know that we continue to perform well in all of our regions. All of our regions have been growing double digits. I think the other thing is, you know, whether or not that market grows, we've got, you know, more data coming out on our On-X valve. We've got, you know, a 500 patient post-approval trial that'll be presented here shortly with, you know, excellent data.

It's just a continuation of just, you know, pounding the drum on it's the best aortic valve in the world, and, you know, we just keep taking share, and we got a great sales team, and they keep doing their job. You know, as we expand internationally, we're, we're getting that message out as well. You know, again, I think there's, there's lots of room for us to continue to grow that business.

Frank Takkinen (Senior Research Analyst of Medical Devices)

Great. Then maybe the last one for Ashley. Just was hoping you could kind of parse through cash generation in the quarter. Clearly, a couple factors that are non-operational or, or not within the regular PNL related to the cash infusion as well as the, the, the cash outflow to Endospan and some cash generation in the business. Was hoping you could kinda bridge us from the $31 million last quarter to the $49 million this quarter, and then help us think about cash generation through the end of the year.

Ashley Lee (CFO)

Yeah. You, you're right, Frank. There, there was a lot of noise in the 2Q. You know, we had the payment to Endospan. We received the PMA milestone payment from, from Baxter. You know, there, there was a fair amount of noise in there. We, when you, when you back all of that out, we, we actually generated free cash flow of $5 million in the 2Q of this year. You know, we've been talking a lot about our focus on not only driving adjusted EBITDA higher, but, but a focus on generating cash as well. We're, we're really pleased with where we ended up in the 2Q.

You know, I don't think that we're quite at the point yet where we're ready to commit to being able to generate a positive free cash flow on an individual quarter basis and a trailing 12-month basis. With, you know, the trends that we've been seeing over the last couple of quarters, we're, we're very encouraged about where we are, and we think that we're getting very close to the point where we will be generating free cash flow both on a quarterly basis and a trailing 12-month basis going forward.

Frank Takkinen (Senior Research Analyst of Medical Devices)

Perfect. I'll stop there. Thanks for taking the questions.

Operator (participant)

Ladies and gentlemen, as a reminder, if you would like to ask a question, please press star one on your touchtone phone. There are no new questions at this time. That concludes our Q&A session. I would now like to turn the floor over to Pat Mackin, President and CEO, for closing remarks.

Pat Mackin (CEO)

Well, listen, thanks for joining the call this afternoon, as you can see, we had a great quarter. We have a lot of confidence in our second half, think we're very well positioned going into 2024 to deliver on our double-digit growth on the top line and $75 million of adjusted EBITDA. Stay tuned, we'll be back next quarter. Thanks for joining.

Operator (participant)

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.