AngioDynamics Q4 2023 Earnings Call Transcript

Quartr
Provided by Quartr
July 12, 2023

There are 7 speakers on the call.

Operator

Morning, and welcome to the AngioDynamics 4th Quarter and Fiscal Year 2023 Earnings Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. As a reminder, this conference call is being recorded. The news release detailing AngioDynamics' 4th quarter and fiscal year 2023 results crossed the wire earlier this morning and is available on This conference call is also being broadcast live over the Internet at the Investors section of the company's website at www.angiodynamics .com and the webcast replay of the call will be available at the same site approximately 1 hour after the end of today's call.

Operator

Before we begin, I would like to caution listeners that during the course of this conference call, the company will make projections or forward looking statements regarding future events, including statements about Expected revenue, adjusted earnings and gross margins for fiscal year 2024 as well as trends that may continue. Management encourages you to review the company's past and future filings with the SEC, including without limitation, the company's Forms 10Q and 10 ks, which identify specific Factors that may cause the actual results or events to differ materially from those described in the forward looking statements. The company will also discuss certain non GAAP financial measures during the call. Management uses these measures to establish operational goals and review operational performance and These measures may assist investors in analyzing the underlying trends in the company's business over time. Investors should consider these non GAAP measures in addition not as a substitute for or as superior to financial reporting measures prepared in accordance with GAAP.

Operator

A slide package offering insight The company's financial results is also available on the Investors section of the company's website under Events and Presentations. This presentation I'd now like to turn the call over to Jim Clemmer, AngioDynamics' President and Chief Executive Officer. Mr. Clemmer?

Speaker 1

Good morning, everyone, and thank you for joining us for AngioDynamics' 4th quarter fiscal 2023 earnings call. Joining me on today's call is Steve Trowbridge, AngioDynamics' Executive Vice President and Chief Financial Officer, We'll provide a detailed analysis of our Q4 and fiscal year financial performance and our fiscal 2024 guidance. FY 2023 saw continued progress against our long term strategy and we have already had an exciting start to FY 2024 With the strategic divestiture that we announced on June 8 and are looking forward to delivering solid pro form a revenue growth this year. We ended the 4th quarter with revenue of $91,100,000 representing growth of 4.7% year over year, led by growth of 17.2% from our MedTech segment. For the full fiscal year, Our revenue was $338,800,000 representing growth of 7.1% over the previous year.

Speaker 1

Our MedTech segment grew 22.8% and our Med Device segment grew 1.9%. We are now 24 months into our 36 month plan and we are progressing at or ahead of our long term revenue targets that we provided in July of 2021. We are very pleased with the results from our Aireon PAD business As we finish the year with revenue of $41,100,000 which was an increase of 41% over FY 2022. We are continuing to gain share in this category based upon the science behind which provides physicians with the power they seek and the safety they require when treating patients with peripheral artery disease. In less than 3 years since launch, Aeryon is becoming a trusted tool and many physicians are also sharing their positive experiences With Orion.

Speaker 1

In addition, we are excited about early findings published in the cardiovascular revascularization medicine Outlining the ability of the Orion laser to fracture medial arterial calcification in small vessels. We will continue to invest in this unique platform and we have plans to launch a venous thrombectomy version of Aireon as well as pursue a pathway to launch a current atherectomy version of Orion in the future. These launches will exponentially increase the addressable markets in which Aireon competes. We also anticipate receiving CE Mark for Aireon in the first half of fiscal twenty twenty four. Our NanoKnife business grew nearly 19% in FY 2023.

Speaker 1

And most importantly, sales of probes grew 27% Over prior year, ahead of our goal, NanoKnife growth from our international team came as they established new relationships With partners who assist in supporting our procedures and our U. S. Growth was driven by continuing interest in this technology As more physicians become aware of our direct and PRESERVE trials, we are really excited to report that our PRESERVE trial Studying the use of NanoKnife to treat intermediate risk prostate cancer is now fully enrolled and we are on track to finish our study and present our results to the FDA in calendar Q3 of 2024. Additionally, in July, in the UK, the National Institute For Health and Care Excellence For NICE Interventional Procedures Committee finalized guidance for IRE in prostate, Moving NanoKnife from research only to special arrangements. We believe this change in guidelines We'll help improve access for patients within the U.

Speaker 1

K. And represents another positive step towards our ultimate goal of having the NanoLife system being recognized as a standard of care for patients with intermediate risk prostate cancer. NICE guidance is recognized as a leading authority in healthcare decision making due to its rigorous evaluation process and evidence based approach. And we are encouraged knowing that many regulatory bodies around the world may consider NICE guidance When reviewing healthcare interventions for approvals or when making policy decisions. We believe that NanoKnife has the potential to be one of the most important breakthroughs for men who qualify for our focal treatment approach to their disease by driving beneficial outcomes and offering significant quality of life benefits.

Speaker 1

It also has the potential to open up a roughly $700,000,000 market here in the U. S. And potentially a $2,000,000,000 market globally for those intermediate risk patients. In FY 2023, our international business Grew an impressive 12% over prior year and 14% on a constant currency basis. Growth came both from our medtech and med device segments and was also very balanced throughout the geographies that we support.

Speaker 1

Our team is strong and we will continue to grow in international markets through our strategy that employs key partners to support our products, Continued exposure through our series of scientific symposiums and further expansion of our MedTech portfolio As we gain important regulatory approvals around the globe, we believe this is the right approach As it allows us to leverage our partners in both the medtech and med device segments without the significant investment That would be required to build out a fully direct global sales force. Our mechanical thrombectomy business, which includes AngioVac and Alphavac finished the fiscal year with growth of 9.7% over prior year, which was below our expectations. We believe that we have great products that offer excellent clinical outcomes with strong patient safety profiles and we will be launching enhancements to these products that incorporate feedback and insights from our customers and other interested physicians. As we have previously discussed, we are in the early stages Developing our product portfolio in the thrombectomy space. Today, our Alphavac product offerings Are utilized in the large bore subsection of the market and are subject devices for our APeX study.

Speaker 1

Looking ahead, we are preparing to launch a new version of our AUREON product for use in the lower extremity segment of the venous thrombectomy market. We believe that this will be a disruptive technology, giving customers an option to treat small vessel clots Using the power, energy and aspiration capabilities of Arianne, which will be unlike anything else currently on the market, We are planning to launch this product in calendar year 2025. On the clinical front, We are also pleased to report that our APeX study evaluating ALFAVAC F-eighteen As a treatment for pulmonary embolism is more than 50% enrolled and we expect to complete enrollment this winter and submit our results to the FDA in the first half of calendar year twenty twenty four. To achieve our expectations for our thrombectomy business, we are continuing to improve our customer messaging, our training, Our field performance, especially for AngioVac. As we discussed on last quarter's call, The thrombectomy opportunity is very important to our company, and we are confident that our unique designs And ultimately, our comprehensive offering will enable us to drive significant profitable growth in this business for years to come, even with strong competition in the market.

Speaker 1

Our Med Device segment Grew 1.9% over prior year, in line with the expectations that we set during our Investor and Technology Day in July of 2021. This important segment will continue to provide a stable cash generation and earnings profile as it does not require the same level of annual investment as our MedTech platforms require. On June 8, we announced the divestiture of our dialysis and BioSentry businesses to Merit Medical. These businesses were divested for two reasons. First, it will allow us to focus on fewer product categories and allocate our resources to areas that are better aligned with our long term portfolio objectives.

Speaker 1

And second, we were able to strengthen our balance sheet. And today, we are in a strong net cash position with no need to utilize outside sources to fund our investments in the future. We have always said that we would be active portfolio managers, and this move shows that when value generating opportunities arise To better align our portfolio with our long term strategic goals, we'll execute upon them. And finally, on June 1, 2023, in our ongoing IP lawsuit with B. V.

Speaker 1

Bard, The United States District Court in Delaware granted our motion for a judgment as a matter of law, Declaring that the patents asserted by Bard are invalid as anticipated, indefinite and ineligible and not infringed. The decision is consistent with our position and our arguments in the case since it was brought in 2015. We expect this decision to be appealed by Bard, but we believe That it is supported by the facts and reflects our meritorious defenses and positions in the other cases pending with Bard in Delaware and Utah. While the case may not be definitively over yet, we believe that the judge's ruling is accurate and gets us one step closer to finally putting this matter to rest. Before I turn the call over to Steve, I'd like to thank our team here at AngioDynamics for their commitment to executing upon our strategy and becoming a high growth profitable medtech company.

Speaker 1

We are excited about last month's divestiture announcement and the fact that we are now in a net cash position with a simpler, more well defined portfolio. With that, let me turn the call over to Steve Trowbridge. Steve?

Speaker 2

Thanks, Jim. Good morning, everyone. Before I begin, I'd like to direct everyone to the presentation on our Investor Relations website summarizing the key items from our quarterly and fiscal year results. Our revenue for the Q4 of FY2023 increased 4.7% year over year to $91,100,000 driven by continued strength in our medtech platforms, including Aireon, NanoKnife and thrombectomy. We are pleased with the growth year over year, particularly in light of the fact that we had a very strong Q4 last year as our capacity improvement initiatives significantly reduced The existing back order at that time.

Speaker 2

Last year's Q4 exhibited growth of 13.2% over the prior year. So our results for our Q4 of FY 2023 illustrate continued strong execution against our strategic plan. Medtech revenue was $26,500,000 a 17.2% year over year increase, while med device revenue With $64,600,000 growing 0.3% compared to the Q4 of FY 2022. For the full year 2023, Our medtech platform grew 22.8% and our med device businesses grew 1.9% compared to the prior year period. Through the 1st 2 years of our 3 year plan, our MedTech segment has grown at a CAGR of 33.1%.

Speaker 2

For the 4th fiscal quarter, our MedTech platforms comprised 29% of our total revenue. For the full year 2023, our MedTech platforms comprised 29% of our total revenue compared to 25% for fiscal 2022. Our Aireon platform contributed $11,800,000 in revenue during the Q4, growing 22% compared to last year. As Jim mentioned, we are very pleased with the trajectory of this business and are developing additional indications in the VTE space as well as international opportunities in that we think will open up additional significant addressable markets. Mechanical thrombectomy revenue, which includes AngioVac and Alphavec sales Increased 3.7% over the Q4 of FY 2022.

Speaker 2

Alphavac revenue for the Q4 was 1,800,000 Both the F-twenty two and F-twenty 18 versions of Alphavac are performing well and receiving positive physician feedback. For the full year 2023, revenue for Alphavac was $7,200,000 AngioVac revenue was $100,000 in the quarter, representing a decline of 8.3% over the prior year, but up sequentially from the 3rd quarter. As Jim mentioned, AngioVax saw ongoing challenges during the year and we've taken meaningful action to address these challenges and are committed to executing against them in 2024. For the full year 2023, AngioVac revenue was $24,500,000 a decline of 8.2%. We remain confident that mechanical thrombectomy will be a significant contributor to our growth strategy and we will continue to prioritize investments in this platform, including the new product introductions that Jim mentioned as well as our clinical initiatives such as the APeX PE study.

Speaker 2

Nanoknight Disposable revenue during the quarter increased 28% year over year. For the full year 2023, sales of Nanoknight Disposables Grew 27.1 percent. We continue to see this business perform very well both in our U. S. And in international markets and we're pleased to announce that enrollment in Preserve is now 100% complete.

Speaker 2

In the 4th quarter, our Med Device segment grew 0.3% year over year, led by strength in our angiographic products and the dialysis business. As of the end of the Q4, our backlog stood at $2,700,000 For the full year 2023, our Med Device segment grew 1.9%, in line with our long term target of 1% to 3% growth. Moving down to the income statement. Our gross margin for the Q4 of FY 2023 was 50.9%, a decrease of 2 50 basis points compared to the year ago period. For the full year 2023, gross margin was 51.4%, a decrease of 100 basis points compared to fiscal year 2022.

Speaker 2

For the Q4, MedTech gross margin was 64.7%, a decrease of 400 basis points And med device gross margin was 45.2%, a decrease of 280 basis points, each when compared to the Q4 of last year. For the full year, MedTech gross margins were 64.1%, a decrease of 2 70 basis points and Med Device margins 46.4 percent, a decrease of 120 basis points, again each when compared to the full year 2022. As we've discussed, our strategic business model contemplates gross margin expansion as our higher margin medtech segment Continues to become a larger portion of our overall revenue base. We have seen this dynamic. However, the overall impact Has been mitigated by the supply chain disruptions and inflationary pressures that we've experienced over the past 2 years.

Speaker 2

When looking specifically at the MedTech segment, Gross margins remain significantly ahead of overall corporate margins. The quarterly and year over year performance was negatively impacted by the revenue performance of AngioVac and increased capital placements. The pay down of the IIA royalty that we discussed in Q1 provided approximately a $1,000,000 over the course of the year, partially offsetting these headwinds. Med Device margins were positively impacted by increased productivity, But this benefit was more than offset by the continued inflationary environment, the hurdle created by the CARES Act benefit in FY 2022 and the mix shift resulting from increased international growth. Turning to R and D, Our research and development expenses during the Q4 of FY2023 was $7,900,000 or 8.6 percent of sales compared to $7,900,000 or 9 percent of sales a year ago.

Speaker 2

Our disciplined investment in R and D will continue to drive growth across our key technology platforms and includes the clinical and product development spend for our MedTech portfolio. R and D expense for the full year 2023 was $29,900,000 or 8.8 percent of sales compared to $30,700,000 or 9.7 percent of sales in the previous year. For FY 2024, we anticipate R and D spend to target 9% to 11% of sales. When accounting for the divestiture of our dialysis and BioSentry businesses that was completed in June of this year, R and D spend In FY 2023 on a pro form a basis was 9.6 percent of sales. SG and A expense for the Q4 of FY 2023 was $36,500,000 representing 40.1 percent of sales compared to $37,900,000 or 43.6 percent of sales a year ago.

Speaker 2

For the full year 2023, SG and A expense was $144,300,000 representing 42.6 percent of sales compared to $133,800,000 representing 42.3 percent of sales in FY 2022. For FY 2024, we anticipate SG and A spend to target 45% to 48% of revenue. When accounting for the divestiture, SG and A spend in FY2023 on a pro form a basis was 47.1 percent of sales. As we stated at the time of the divestiture, there was not a significant amount of direct cost that were associated with the dialysis and BioSentry businesses. As a result, our expectations for SG and A spend in FY 2024 Do include leverage with respect to G and A spending, but also include an increase as a percent of sales in sales and marketing.

Speaker 2

Our adjusted net income for the Q4 of FY2023 was $700,000 or adjusted earnings per share of $0.02 compared to an adjusted net income of $300,000 or adjusted earnings per share of $0.01 in the Q4 of last year. For the full year 2023, adjusted net loss was $2,400,000 or adjusted loss per share of $0.06 compared to an adjusted net loss of $200,000 or approximately breakeven on a per share basis a year ago. As a reminder, our adjusted earnings per share in FY 2022 included a $4,200,000 or $0.08 per share benefit related to the reimbursement of certain expenses under the employee retention credit as part of the CARES Act with no corresponding benefit in our GAAP net income as reported in our earnings release this morning Included a goodwill impairment related to our Med Device segment in connection with the divestiture of our Dialysis and BioSentry businesses. These businesses that were divested on June 8, 2023 subsequent to our fiscal year end were accounted for as held for sale as of May 31, 2023. So as a result, we recorded a goodwill impairment during the fiscal Q4 ended May 31, 2023.

Speaker 2

The impairment resulted in a loss of $14,500,000 or $0.37 per share on a GAAP basis. Due to the timing of the transaction, the loss is recorded in our 4th fiscal quarter for FY2023, but the offsetting gain on the sale of the assets won't be recorded until our 1st fiscal quarter of FY 2024. Result is a large GAAP loss in the Q4 of 2023, But then what will be a larger GAAP gain in the Q1 of FY 2024? Adjusted EBITDA in the Q4 of FY2023 3 was $7,900,000 compared to $6,200,000 in the Q4 of FY 2022. For the full year 2023, Adjusted EBITDA was $22,600,000 compared to $20,900,000 in FY 2022, representing year over year growth of over 8.3%.

Speaker 2

In the Q4 of fiscal 2023, we generated $16,000,000 in operating cash, had capital expenditures of $1,100,000 and additions to Arianne placement and evaluation units of $500,000 At May 31, 2023, which is prior to the divestiture, We had $44,600,000 in cash and cash equivalents compared to $30,100,000 in cash and cash equivalents at February 28, 2023. We had $25,000,000 outstanding under our revolving credit facility and $25,000,000 outstanding under our delayed draw term loan at May 31, 2023 equal to the amounts outstanding under these facilities at February 28. Subsequent to quarter end, we used part of the proceeds from the divestiture to extinguish our debt. As a result, we currently have significant cash balances and 0 debt. As is always the case, we Our first fiscal quarter to have the highest utilization of cash during the fiscal year with cash balances building throughout the remainder of the fiscal year.

Speaker 2

So we expect to finish fiscal year 2024 with cash balances in the range of $65,000,000 to $70,000,000 And we expect to be approaching cash flow positive By the end of FY 2025, having utilized an aggregate of $10,000,000 to $20,000,000 over the 2 year period. Now said another way, immediately after the transaction when accounting for tax and deal costs, we had $90,000,000 of cash. In June, We paid the $10,000,000 Arian earn out and expect to pay the next $5,000,000 Arian earn out by the end of our fiscal 2024, with a final $5,000,000 payment expected to occur in FY 2025. So that $15,000,000 of 20 4 milestone payments Brings that $90,000,000 plus down to $75,000,000 in FY 2024. We expect to end our fiscal year 2024 with cash balances of $65,000,000 to $70,000,000 reflecting operating cash usage of $5,000,000 to $10,000,000 for the year.

Speaker 2

Again, given the timing of Q1 payments In managing our working capital, Q1 will exhibit cash utilization with balances then growing throughout the year. We believe that we have more than sufficient cash to execute on our In 2019, we began a transformation of AngioDynamics. The first step of the transformation was to fundamentally change our portfolio to incorporate platform technologies that can provide a unique advantage and compete in higher growth, high margin, large total addressable markets. We began the transformation by selling our largest business at the time, our name is Fluid Management Business and then investing a third of the proceeds from that sale to buy Eximo Medical, an early stage Israeli startup, which led to the Orion PAD laser. We've continued our strategic transformation, reporting our business in 2 segments, medtech and med device, using internal R and D to launch our Alphavac mechanical thrombectomy device and by investing in clinical initiatives to expand into specific uses including our APeX study for PE and our PRESERVE study for the use of NanoKnife to treat intermediate risk prostate cancer patients.

Speaker 2

In July of 2021, we articulated a goal of executing to a 3 year CAGR for our MedTech segment of 30% to 35%. Through 2 years of that 3 year plan, Our MedTech segment has a CAGR of 33%. We've indicated that we would be active portfolio managers with the goal of focusing our company on our strategic objectives. In June of this year, we completed the divestiture of our dialysis and BioSentry businesses, which recapitalized our balance sheet and enhanced our medtech focus. Gross margin expansion has proved challenging.

Speaker 2

Coming out of the COVID global pandemic, we've been impacted by the tight labor market, which has not fully rebounded. In addition, our med device businesses contain a wide and varied product offering That leaves us under scale and it makes us susceptible to inflationary pressures limiting our ability to drive efficiencies. The next phase of our transformation is to address the scale and structural limitations of our operating footprint in a capital efficient manner. And we look forward to continuing to update you on our plans and actions to drive margin enhancement in the short and medium term. Turning now to guidance.

Speaker 2

We anticipate that FY 2024 revenue will be in the range of $328,000,000 to $333,000,000 and we expect Full year adjusted loss per share to be in the range of $0.28 to 0 point 3 $4 As a reminder, this compares Fiscal year 2020 pro form a revenue of $306,300,000 and pro form a loss per share of $0.43 when excluding the recently divested assets. Those divested assets carried very little direct cost, which means While the transaction provided significant cash proceeds, it is dilutive to both corporate margins and at a larger clip to the earnings line. We expect FY2024 gross margin to be in the range of 50% to 52% compared to pro form a FY2023 gross margin of 50.5%. For FY 2024, we expect MedTech revenue growth in the range of 20% to 25% and med device revenue growth in the range of 1% to 3%. We expect med tech gross margins in the range of 63% to 65% And Med Device gross margins in the range of 43% to 45%.

Speaker 2

With that, I'll turn it

Speaker 1

back to Jim. Thanks, Steve. Our FY2023 and the subsequent divestiture have positioned us to continue investing and growing the business In FY 2024, while also managing our cost structure and looking to expand the margin profile of our business. We're excited with where we are today, while also looking forward to introducing new products and new indications to the market and opening up additional adjustable markets for our existing products. Our team did a commendable job in FY2023, Showing true dedication to our strategy and I'm very proud of what they've accomplished and the transformation of AngioDynamics so far.

Speaker 1

When we sold Namic in 2019, we told you that we are going to be a different company, 1 driven by innovation, science and data generation. Since then, we have taken the necessary steps and have made the necessary investments to set AngioDynamics up to win. This doesn't take place overnight And as part of the organizational journey when becoming a science based company, the most successful companies in medtech Got to where they are by delivering innovation to the customer and to the patient. We are committed to that process of delivering innovation And to challenging the current standards of care, we believe that our portfolio will do just that over the next 5 years, fueled by our investments in R and D, clinical expansion and sales and marketing resources. These investments and the important research that is being done today are the fuel that will power us to significantly expand our presence in large adjustable markets and generate profitable growth for years to come.

Speaker 1

With that, Operator, I'd like to turn the call back and take questions.

Speaker 3

Thank

Speaker 4

you. We'll now be conducting a question and answer session. One moment please while we poll for questions. Thank

Speaker 3

you. And

Speaker 4

our first question comes from the line of

Speaker 1

Hi, Jason. Good morning. Yes.

Speaker 5

Good morning. Okay. So just on the EPS guide, perhaps surprising a few folks, It seems pretty consistent with your disclosures around profitability of the divested business. I think part of the problem You haven't really tackled the pseudo fixed cost tied to the divested business. So my question is, When do you start pulling out some of the cost and kind of rightsizing the cost structure for 30 some odd 1,000,000 less in

Speaker 2

Yes. It's a good question, Jason. As we had indicated when we first announced The divestiture, there weren't a lot of direct costs that come with this business, but we are going to be tackling those costs. And so the guide partially reflects The fact that right off the bat, we're going to continue to run our business and then over time Look to right size it as we get some operating experience. So I do expect you're going to see some of those costs But you're also going to see us continue to grow into the structure that we have.

Speaker 2

So, I think it's going to be a little bit of I mean process, but also we did make that choice to monetize those assets and recapitalize the balance sheet and we made that trade off a little bit for operating profit during the year.

Speaker 5

Okay. And just as it relates to the deal, should we expect more divestitures in fiscal 2024?

Speaker 1

Hi, Jason, it's Jim. As we've said before, we've tried to let our investors see our focus strategically towards a MedTech platform. That still comprises only about 30% of our company's revenue. So we want to continue to focus there. We have a lot of moving parts here.

Speaker 1

So it's easier to operate the company with less moving parts, easier to focus our investments going forward. And some of those things are challenges, Jason, during COVID With supply chain challenges when you have this many products and categories that you serve, so we'll watch and see. We've mentioned we'll be active portfolio managers, And we'll make sure that we do the right thing to keep our strategic goals in line, yet still back to what Steve said, making sure that our growth comes with a profitability that investors We're pleased to see, may take a little bit of time to get there. We've tried to outline that to you guys, but we'll be active in our portfolio management.

Speaker 5

Okay. And just on the cash, obviously, the cash position has flipped here. You're burning a little bit of cash, not a ton, but can you just walk through your plans for capital Allocation, what are you going to do with the cash?

Speaker 2

Yes, good question. I think what our current projection is to take a little bit of time 6, 8, 10 months And keep the cash. We want to be able to illustrate externally that we can manage the business in accordance with the guidance that we gave today. We want to That we're not burning a significant amount of cash. And then as we exit that timeframe and we're getting back to the cash flow positive, that's when we'll be a little bit more Clear in terms of indications at that time of use of the cash.

Speaker 2

As of right now, we don't have any expectations of going out and doing divestitures or spending Cash, we're going to continue to keep that cash and then illustrate our operating model before we move into uses of that cash.

Speaker 5

Okay. And I'll just ask one more and then jump back in the queue. On thrombectomy, you mentioned that you'll be launching Enhancements, product enhancements, can you just walk through the timing of those enhancements?

Speaker 1

Yes, Jason, it's Jim. Just some of the feedback we received now that AngioVac has been out in the market for just over We've got some great feedback on how it works, the safety and efficacy that it gives the physicians, but you always get good feedback. So we're looking at making some product enhancements as anybody would do on 2.0 version adding some things. We expect some of those enhancements to be launched in calendar 2025. I'm sorry, Jason, calendar 2024, being confused on our fiscal year, next calendar year.

Speaker 5

Okay. Thank you.

Speaker 1

Thanks, Jason.

Speaker 4

Our next question is coming from the line of Bill Plankovitch with Canaccord Genuity. Please proceed with your question.

Speaker 6

Great. Thanks for taking my questions. Good morning. First off, just the Aeryon product, Yes, the uses seem to be expanding as you talk about the thrombectomy and then going into coronary. Just Trying to kind of get wrap my head around, one, as we look at the business today That was really solid growth.

Speaker 6

How much of that was U. S. Versus OUS driven? How much of that is outpatient versus OBL? And then just 2, how should we think about this strategically as you move forward?

Speaker 6

It seems like this product is becoming a bigger and bigger

Speaker 1

Yes. So Bill, good question. So first of all, almost every dollar of revenue that we had in 2023 was in the U. S. So we're gaining our CE mark as we speak.

Speaker 1

We said we expect that in the first half of This fiscal year, there was some research that was done in Europe and some of that was being published. We've talked about it by some clinicians and physicians in Europe. We're really excited by Aireon. We look forward to seeing what they're doing, but almost all that was U. S.-based.

Speaker 1

And second, we're running now at a clip, I call it 75% OBL revenue and 25% hospital revenue. That's increasing. The hospital percentage is increasing as we speak, which we would expect. As you know, we launched in September of 2020. During the pandemic, it was harder to get access in the hospitals at the time.

Speaker 1

So our initial customers are OBL related, but we're watching that mix And finally, Bill, your question is a great one. When we acquired Eskimo Medical, we believed And what it could do in this market, in the PAD market and challenging the 4 good companies that we compete with. These guys are good companies with good products. We knew what Arianne did was special and could create a spot in the market. We're proving that.

Speaker 1

We also knew How it works, the mechanism of action and the science behind it could be applicable in other parts of the anatomy and other disease states. And that's what we now have a lot of confidence in. So talking about launching the venous version in FY sorry, in calendar year 2025 is important to us as we'll round out our thrombectomy portfolio With Orion in that small vessel platform and also Bill, we really believe as well as it works in peripheral artery disease, well, we can do the same thing in coronary, giving doctors the Safety they require, treating coronary indications and also the power of how Orion delivers the energy within that vessel wall To break up calcium in clot. So that will be part of our future as you identified.

Speaker 6

And then given the Moving into these new indications, are there major studies that we should be tracking? How do we think about that? And then just on the AlphaVac, that seems obviously to be going a little slower than original expectations. And how is that until we get the F-eighteen for PE, you're going to be kind of hand side behind your back on that one in terms Growth, how should we think about that until the PE indication comes?

Speaker 1

It's a good question. As far as the AURION version for thrombectomy, that's a 510 process. So there won't be a lot of studies required to get through the 510 process that's built into our development and launch models that we have. And second, if we do a coronary model, there is a pathway that exists today. So we would expect a study there, more of a PMA process.

Speaker 1

So We'll highlight and gave you guys more guidance as we get closer. It will be more complicated, but there is a pathway that we'll follow, that the FDA kind of has it in place today. And then second back to you mentioned about Alphabac, we actually achieved the revenue we gave as guidance last year, 7% to 9%, I think is what we talked about. So within that range, but it's true. We really learned a lot during the course of the year, talked about enhancements we'll make from some customer feedback.

Speaker 1

But overall, the product is really safe and effective. People are getting very confident when they use it as to how well it works. We also think the out the APeX study will open up that large PE market for us. And today, we're in that study phase, More than half enrolled, which is great, but we really want to unlock that finish the study, unlock that PE market. So until then, we'll do what you would expect us to do.

Speaker 1

We'll tread lightly. We'll educate physicians on our product. There are spots they can use it, within the anatomy today to remove clot and that's what we'll work on As well as finishing the study. When that study comes out, Bill, it opens up a large market for us. We think we'll see large growth from there.

Speaker 6

Okay. And last question, I promise, just on PRESERVE studies enrolled. Just give us timelines for data, Submission, approval, I assume this is a 510, I believe. How should we think about that? And then how do you expect the impact on the business?

Speaker 6

How should we think about the timing for that the data be seminated into the marketplace and potentially drive that business. Thanks for taking my questions today.

Speaker 1

Bill, good question. So we're excited that we've completely enrolled the study. The study has a 12 month follow-up. So we'd expect us over the course of the year until next July, Complete the follow-up, compile the data, we'll submit to the FDA not long after that. And we expect really if the process goes well, To receive an indication by end of calendar year 2024.

Speaker 1

We hope along the way we can publish some data and make it public. During that process, we think it will be compelling. If it's based upon other data that you know has been published around the globe by physicians who've utilized this unique device To treat these intermediate risk prostate cancer patients, we believe the data is going to be compelling, not only because it reduced the effect of the tumor, but We also give the quality of life benefits back to those patients that they would risk with other procedures. So we're excited, Bill. We're going to again just continue what we're doing today, Support our customers, but we would expect when we receive that indication, you'll see a different selling and marketing and clinical support approach from our company To maximize the opportunity in this market, that will really kick in more in calendar year 2025 after that indication is received.

Speaker 6

Thanks for taking my question.

Speaker 2

Thank you.

Speaker 4

The next question is from the line of Matthew Mishan with KeyBanc Capital Markets, please proceed with your question.

Speaker 3

Thanks. Good morning. Thanks for taking the questions. Hey, Jim, Steve, It seems like you're taking a little bit of a different approach to guidance this year, especially around some of the individual moving pieces. But could you Help us build up to that 20% to 25% medtech guidance for FY 'twenty four.

Speaker 3

What is, what's above, what's below and how you're accounting for AngioVaca, Matt?

Speaker 2

Yes, it's a good question, Matt. So we are in the past couple of years as we were really just getting to the point of first reporting our business And in the 2 reportable seconds MedTech and Med Device and with some brand new product launches, we did feel that it was important to give you guys a little bit more granularity. You've been able to see the progression and the trajectory of our businesses. So when you think about building up to that medtech guide of 20%, 25% growth, You've seen the trajectory from Aeryon. We talked about continuing to be pleased with what we're seeing with Aeryon and continued opportunities to take share as well as increase utilization within our installed base.

Speaker 2

So you can think of Arianne on that same trajectory. Again with NanoKnife, you've seen more than 20 plus percent growth in probes as we continue to execute on our trials and continue to see really strong growth in the U. S. As well as international markets, very, very similar trajectory with NanoKnife. To your question around thrombectomy, this is the 2nd year of launch for Alphavac.

Speaker 2

That's a growth product for us. We're going to continue to see some good growth in Alphavac. We did clearly take into account when we were building our models what we saw last year with AngioVac. We're still excited about AngioVac. It still has A growth opportunity for us, but as we talked about in Q3, we're kind of turning the ship from what we saw was the valley for AngioVac.

Speaker 2

You saw Q4 sequentially up, so clearly we think we've turned that trend. But we've taken that into account and as we've Given you guys the guidance and thought about building up our models in medtech.

Speaker 3

Okay. That's helpful. And is the way to Think about the mechanical thrombectomy platform and that You'll hopefully execute with the FDA and get an indication for Pulmonary embolism at some point towards the end of this fiscal year, middle of next year. And at the same time, given it does seem like it's a 510 process, you potentially could launch in that same year A DVT product with Orion, is that the right way to think about A year out like FY 2025 as pipeline?

Speaker 1

Yes. Matt, your timeline is pretty good. So we agree with you on what you just said about APeX PE, Completing that study and maybe getting an indication. We gave a rough range because there's still a lot of regulatory work to do. But your timeline is aligned with RSV.

Speaker 1

Assume, Call it a year from now, we think we'd have that APeX P indication. And then about a year after that, we talked today, I mentioned during calendar year 2025 Having the AURION version for venous thrombectomy being launched. So we really have the next 24 months will be exciting in that spot. Having the PE indication for Apex, that's important. Having some design enhancements and developments added during the next calendar year, Then the Orion version coming out in calendar 'twenty five, we're really excited over these next 24 months of how we'll be significant player in that market with a really neat portfolio.

Speaker 3

And then on the Orion International opportunity, I'm just curious, is the model going to be different there, where there may be capital purchases of the equipment? Or is it still the same commercial model, where you take that on your balance sheet, and it's really just the

Speaker 1

Great question. Thanks for asking. We're seeing a different approach, Matt. It didn't have the amount of Kind of history built by the other player in the market who had utilized the approach already providing capital to market. That was more prevalent in the U.

Speaker 1

S. So we're already seeing a different approach Towards the European market, we'll give you more details as we get into the market. But I think the model you're talking about, capital being done differently is what we expect as well. So it won't require as much significant investment from us to bring new customers online.

Speaker 3

Okay. Outstanding. Thank you.

Speaker 1

Thank you, Matt.

Speaker 4

Thank you. At this time, we've reached the end of the question and answer session.

Speaker 3

I'll turn the call over

Speaker 4

to Jim Klemmer for closing remarks.

Speaker 1

Thank you, operator, and thanks again to the team at AngioDynamics. Hope that the investors are seeing our commitment to our transformation as we're going to become a growth company That does provide profitability to the bottom line for years to come based and founded by innovation and the quality of our products. Thank you for joining us today. We'll speak again soon.

Speaker 4

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.

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Earnings Conference Call
AngioDynamics Q4 2023
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