Earnings Call Transcript - ANGO Q1 2020

Operator, Operator

Good morning, and welcome to the AngioDynamics Fiscal Year 2020 First Quarter 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 is being recorded. The news release detailing the fiscal 2020 first quarter results crossed the wire earlier this morning and is available on the Company’s website. 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 one hour after the end of today’s call. 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 2020. Management encourages you to review the Company’s past and future filings with the SEC, including without limitation, the Company's forms 10-Q and 10-K, which identify specific factors that may cause the actual results or events to differ materially from those described in the forward-looking statements. A slide package offering insight into the Company's financial results is also available on the Investors section of the Company's website under Events & Presentations. This presentation should be read in conjunction with the press release discussing the Company's operating results and financial performance during this morning's conference call. I'd now like to turn the call over to Jim Clemmer, AngioDynamics' President and Chief Executive Officer. Mr. Clemmer?

Jim Clemmer, President and CEO

Thank you, Rob, and good morning, everyone. I appreciate you joining us for AngioDynamics’ fiscal 2020 first quarter earnings call. Michael Greiner, our Executive Vice President and Chief Financial Officer, is with me today and will offer a detailed analysis of our first quarter financial performance. I want to start by highlighting our operating and execution accomplishments for the quarter. I am very pleased with our strong financial performance and the strategic and operational progress we have made towards our long-term vision during this period. AngioDynamics has transformed significantly in the past year, and I believe we will look even more different a year from now. We are committed to developing and acquiring innovative technologies that enhance our oncology and thrombus management platforms. Research and development remains a key priority for us, and we are on track to launch several new products and enhancements in fiscal 2020. We are also assessing our portfolio and may consider divesting businesses that do not align with our long-term vision. For instance, the sale of our NAMIC business in late fiscal 2019 enables us to invest more aggressively internally and take opportunistic stands in M&A, as evidenced by the acquisition we disclosed this morning. The acquisition of Eximo Medical Limited aligns with our strategy of acquiring innovative and disruptive technologies in the clotting space and complements our AngioVac platform. Eximo’s laser atherectomy technology offers a differentiated therapy that is well-positioned to gain market share in a large and expanding market with established reimbursement dynamics. This exciting addition to our portfolio is currently in a limited launch stage, and we plan to develop a significant commercial and sales organization in the upcoming quarters to support its anticipated growth as it enters this sizable market. We are prepared to make substantial investments to support future growth opportunities associated with this product and potentially to explore additional markets. Eximo is not expected to materially impact our revenue in fiscal year 2020. As we noted in our earnings release, we have adjusted our expectations for this year's adjusted EPS to a range of $0.10 to $0.15. We expect a meaningful revenue increase in the coming years as clinicians become more familiar with the improved outcomes and ease of use provided by this technology, compared to current treatment options. This innovative laser technology allows clinicians to perform atherectomy in a more versatile and user-friendly manner than existing methods, including other laser atherectomy devices. We are confident that clinicians will recognize the value of this product. We are paying $46 million upfront for Eximo, with additional earn-outs totaling $20 million tied to technical and revenue milestones. Now, regarding NanoKnife, we continue to gain momentum as seven study sites have received IRB approval for our DIRECT study. We anticipate that up to 10 more sites will receive IRB approval by the end of our fiscal year, consistent with our previous expectations. Additionally, we are collaborating with the sites necessary to complete our prostate safety study by the end of this fiscal year. We look forward to sharing updates on both of these exciting NanoKnife studies in the coming quarters. As I mentioned earlier, our R&D initiatives will enable us to launch various new products and extensions in fiscal 2020. We are on track with these introductions, which include an enhanced version of AngioVac, launched last week, featuring new cannula shapes to boost device efficiency, serving as a crucial stepping stone for further development within our thrombus management portfolio. Our NanoKnife 3.0 generator, which has already been launched, has sold two units in the first quarter. Additionally, we are introducing three new products in our vascular access portfolio, which includes new ports that integrate our Vortex port body with BioFlo catheter technology, along with new dual and triple lumen catheters to expand our acute dialysis offerings. We also recently established a dual-source group purchasing agreement with Premier to supply implantable infusion ports, including BioFlo, Vortex, and Xcela, alongside two sole-source agreements with the ASCEND and SURPASS membership groups. This announcement excites us as it grants access to Premier’s extensive network of around 4,000 U.S. hospitals and 165,000 additional providers, while further validating our high-quality portfolio of port products. I am very pleased with our ongoing operational advancements. Our team is making significant progress on our strategic initiatives. We are enthusiastic about the future of AngioDynamics. As I noted earlier, we will maintain our focus on M&A and R&D efforts in oncology and thrombus management solutions that position us in attractive markets. A recent example of executing our strategy is the divestiture of our fluid management business. We exited a mature $200 million market with slow to moderate growth, and have now entered a rapidly growing market of over $500 million with the acquisition of Eximo that we announced today.

Michael Greiner, Executive Vice President and CFO

Thanks, Jim, and good morning, everyone. Before I begin, please remember that we post a presentation on our Investor Relations website, summarizing the key items associated with our quarterly and year-end results, as well as our financial guidance. Unless otherwise noted, all prior year results and comparisons exclude the contribution of our NAMIC Fluid Management business from the prior year. Our net sales for the first quarter of fiscal 2020 were $66 million, representing year-over-year growth of 3.3% when including our RadiaDyne and BioSentry acquisitions, and a 1% decline on an organic basis. Excluding the fiscal 2019 revenue contribution from our Asclera product, which we stopped distributing during the fourth quarter of fiscal year 2019, revenue growth for the first quarter was 5.6%, representing organic growth of 1.3%. On an organic basis, our AngioVac dialysis catheter and thrombolytic products exhibited solid growth during the quarter. Separately, our venous insufficiency products returned to growth when excluding Asclera. These pockets of growth were offset by declines in our PICCs and Ports products as well. We continue to see traction around our prior year acquisitions, specifically the BioSentry Tract Sealant System and the Alatus and IsoLoc balloon products. We have not seen meaningful revenue yet related to our OARtrac system and are still determining the appropriate go-to-market strategy for ensuring proper and long-term acceptance of this technology in the marketplace. Our total VIT business grew 1.1% year-over-year, and excluding Asclera grew 6.4%. Strong growth in AngioVac and our thrombolytic products, as well as slight growth in our venous products excluding Asclera, were partially offset by a slight decline in our core business. Turning to AngioVac within our VIT portfolio, procedural volume remained strong with procedures increasing 38% year-over-year, representing our eighth consecutive quarter of double-digit volume and revenue growth and continues to validate our strategy to build or acquire complementary products that will fill in the moderately complex gap within our current thrombus platform. Also, I'm excited to share that we completed over 100 cases during the month of September, our first month ever with more than 100 cases completed with our AngioVac products. Vascular access revenue declined roughly 2.7% during the first quarter as continued strong performance in sales of our dialysis products and growth in midlines was offset by declines in sales of PICCs and Ports. Revenue from our oncology business increased 20.9%, primarily related to the prior year acquisitions as well as growth from NanoKnife and Solero. This growth was partially offset by continued anticipated decline in sales of our Radiofrequency Ablation products. Now, moving down the income statement. Our gross margin for the first quarter of fiscal 2020 was 57.9%, up 170 basis points compared to a year ago, driven by productivity and supply chain improvements as well as positive product mix. Our research and development expenses during the first quarter of fiscal 2020 were $6.3 million or 9.5% of sales compared to $7.4 million or 11.5% of sales a year ago. As we have previously messaged, we are continuing to invest in R&D and clinical to support the growth of our core strategic technologies. We now expect R&D spend to be between $32 million and $34 million in fiscal year 2020 as a result of investments related to our acquisition of Eximo. SG&A expense for the first quarter of fiscal 2020 increased to $27.8 million, representing 42.1% of sales, compared to $26.8 million, representing 42% of sales a year ago. Inclusive of the Eximo acquisition spend, we anticipate SG&A to be between $126 million and $130 million for fiscal year 2020. This increase in spend will support our upcoming product launches that Jim discussed earlier, as well as the required investments for a full market release of Eximo in the back half of this fiscal year. Our adjusted net income for the first quarter of fiscal 2020 was $3.2 million or $0.08 per share, compared to adjusted net income of $0.7 million or $0.02 per share in the first quarter of last year. Adjusted EBITDAS in the first quarter of fiscal 2020 was $7.3 million, compared to $5.4 million in the first quarter of last year. And in the first quarter of fiscal 2020, we used $6.5 million of cash in operating activities, while our free cash flow was negative $7.9 million. We began the quarter with roughly $227.6 million in cash, following our NAMIC divestiture. As of August 31, 2019, we had $83.6 million in cash and cash equivalents and no debt. As of today, post the announced acquisition of Eximo, we have approximately $38.7 million in cash and cash equivalents and still no outstanding debt. With regards to our financial guidance for fiscal 2020, which includes the impact of the Eximo acquisition announced this morning, we continue to expect net sales in the range of $280 million to $286 million, and gross margin in the range of 58% to 59%. We also now anticipate adjusted EPS in the range of $0.10 to $0.15, which, as Jim mentioned, contemplates the aforementioned investment that is required this year to build out our commercial footprint to support our Eximo acquisition.

Operator, Operator

Thank you. We'll now be conducting a question-and-answer session. Our first question comes from the line of Matthew Mishan with KeyBanc. Please proceed with your question.

Matthew Mishan, Analyst

Great. Thank you for taking my questions. Hey, Jim, why does Eximo need a standalone sales force, and how many sales people do they have currently?

Jim Clemmer, President and CEO

Matt, good morning. Good question. During our sales diligence process over the last number of months, we approached it with a dual aspect. Because as you know today, we sell products that are used in a lot of the office-based labs, where a lot of the Eximo procedures will be performed. So, those physicians are comfortable with our products, our quality, and our Company today. We looked at adding Eximo to our current sales bag or doing a standalone dedicated sales force. After our diligence, we felt the best way to approach the market, at least initially, is having a dedicated sales force communicating the value of this unique technology to these users. We’re also, Matt, as you know, entering a market that has four strong competitors today. We believe this product itself will stand alone based on the value of its technology, why it's so unique and novel. But we also wanted to make sure we start to communicate that clearly and support those new users with a dedicated team.

Matthew Mishan, Analyst

And then, how many salespeople did this acquisition come with to start off with?

Jim Clemmer, President and CEO

Matt, really, we're buying more or less a startup with very little commercial footprint. It's really why it was such a great matchup. When we met the folks at Eximo, they've done an amazing job developing this technology. They have really brilliant scientists and technology people. This is a unique laser. We can't wait to show the world why it’s so special. They've also done an amazing job on the regulatory and clinical pathway work that has really strong indications that enable us to go to market with a strong claim structure. Now, what they didn't do is build out a commercial team. That's when we met each other. So, we have the value of understanding this market, knowing the key opinion leaders well, and having good commercial experience. So, for us, it's a really good acquisition; and for them, it's a good partnership as well. But, they weren't really looking, Matt, to go commercialize it. We have an individual heading up their U.S. efforts at this point. And now obviously, he's joining our team, and we're going to support those efforts.

Matthew Mishan, Analyst

And then, as a follow-up to that, what does their clinical data say it does better than the standards of care for an atherectomy today?

Jim Clemmer, President and CEO

It's a really good point, Matt. We're proud of what they've done. Let me hand it to Steve Trowbridge, who will handle that for you, Matt.

Steve Trowbridge, Executive VP

Hi, Matt. Thanks for the questions. So, the data that they have was excellent data that they did an IDE trial that supported their 510(k) approval. It was very well run; it was very well controlled. But if you look at the data that comes out of that, what's very unique about this technology is that it is very effective in terms of handling highly calcified lesions, and there's an element of tissue selectivity. So, it goes after calcification without damaging vessel walls. We think it’s a unique opportunity for us to really articulate why this technology is better than the current laser technologies that are out there. We also think it shows promise to take this laser technology and get into a bit of the mechanical market that we have in atherectomy.

Matthew Mishan, Analyst

Excellent. I’ll ask one last question about oncology. Jim, Michael, you have a significant 20% organic growth target for your oncology segment this year. Given the first quarter, how confident are you in the momentum of that business? Additionally, what do you need to see from our OARtrac to achieve this target?

Jim Clemmer, President and CEO

Yes. Matt, good question. So, you know we have large growth expected this year. And I think we told you, we split it into four areas with the two acquisitions being two parts of that, and then again our microwave and our NanoKnife growth. So, first Q is probably softer than we expected, maybe in three of those four categories. But as you've seen from us, we are not running the Company quarter-to-quarter; we stopped giving quarterly guidance and we don't manage it quarter-to-quarter. We have expectations it will still hit the guidance we gave to you guys. And the oncology group is a big part of that. So, we know where our headwinds lie, and we know where our tailwinds are. So, we think we’ll hit what we’ll have out front of you this year, Matt. We have challenges in each of those four categories, but we have plans to hit those. And really what I hope you see is the bigger aspect of what we've done in the last couple of years, especially in oncology. You look at us getting granted the IDE approval earlier this year by the FDA. The last 6 to 8 years, Matt, we sold $6 million to $7 million in the U.S. every year for NanoKnife because we have no indications, and there's really no market we're trying to create. Without an indication, NanoKnife is really a story with nothing else behind it. As we shared with everybody earlier this year, 57,000 Americans are diagnosed annually with this terrible disease of pancreatic cancer. The numbers we shared with you externally, if we can capture roughly 40% of them after we receive, hopefully, a successful indication and approval to go market the device in a couple of years, we think we can capture about $160 million day one with the approval of the indication clear. And that may be conservative; we’ll see. So, we talked about how we're going to expand the market, get to treat patients in need, and become a standard of care. So, we’ll take what’s always been a struggling market behind amazing technology, really expand the marketplace and give AngioDynamics room to operate and give clinicians room to care for and treat people, and that hasn't happened before. So larger macro scale, Matt, that's where we're going with our technology. Short term, we have pressure on the numbers we gave you; we understand it. We have headwinds and tailwinds, and we believe we’ll deliver.

Operator, Operator

Our next question is from the line of Jason Mills with Canaccord Genuity. Please proceed with your question.

Jason Mills, Analyst

I wanted to begin with Eximo. Jim, could you provide us an update on your commercial infrastructure as we approach this deal? Specifically, what will the sales force and its support look like for Eximo once it is fully established through fiscal 2020? I would appreciate your insights on this topic. Over the years, as you know, I have been tracking this stock and have witnessed various shifts in sales force strategy, from separating the sales force to combining it and then transitioning again. You've made significant progress with the commercial infrastructure, and I’d like to know its current status and what it will resemble post-Eximo. Additionally, what are your expectations for its development a couple of years after Eximo is fully launched?

Jim Clemmer, President and CEO

Good question, Jason. So, as you know, our Company has gone through a history of how we do sales. I think, since we've been there, you know that I don't like a matrix organization. We like direct alignment to accountability. You've seen that from how we operate. That being stated, you’ve also seen a little over a year ago, we took our vascular interventions and technologies sales force where we had two. We had one focused on our venous laser group and now one focused on delivering our AngioVac and core products. Before that, it was one group; we split it into two. We've seen now a better dedicated way to communicate the value of AngioVac to those clinicians that use it. And then also the venous laser side, as you seen by our numbers today, something that has declined rapidly for two straight years, we finally flattened out and bottomed as we predicted. Part of that is because we have two different sales forces focused and dedicated to those markets. So, going forward, Jason, as I mentioned earlier, we tested two levels of theory during the diligence process of adding this new Eximo product to one of our current sales bags or going the dedicated route. As we sit here today, we're choosing the dedicated sales route to initially get this product off the ground. Now, two or three years from now, there's a lot of synergy; maybe we'll look at the sales synergy. Today, for a couple of reasons, number one is that the product itself is so special, the technology is so unique; we want to ensure we have a dedicated sales force communicating those benefits to the physicians that will use the product. Number two, we also feel that we have at least four very strong competitors in the market today. Many of those competitors are really focused on delivering their message. So, we want to ensure we have people dedicated that can deliver this message. We evaluated different ways to do this, and at the end of the day, what broke the tie for us was the value of this technology and why it's so special.

Jason Mills, Analyst

Okay. Thanks for that color, Jim. But, you didn't really get to my question, which was size. And if you're not willing to sort of talk about numbers of sales reps today, number dedicated to Eximo amount, maybe you could give us sort of some color qualitatively. It would be helpful to understand. And then, as a follow up to Eximo, what’s the strategy with respect to go-to-market? You mentioned you've got a couple of laser competitors, but you also have several entrenched atherectomy players, large companies and small companies alike. You mentioned that this technology has labeling and application above the knee, below the knee and instant restenosis. So, on the positive side, in my mind, it has some broad indication set. That being said, it’s a lot of geography to cover. As you probably know, in atherectomy, it’s very different above and below the knee; in some respects, focus one place or the other can be helpful. I’m trying to be all things to all people that can sometimes spread you too thin. So, could you talk about go-to-market strategy, where you expect to focus initially? And also, lastly, and then I'll get back out of the way here. There's a lot of earnings you're taking out of the model, but yet you haven't really discussed what sort of revenue might be associated with this in fiscal 2021? I think investors are going to want to know, if you're spending this much money to build out a sales force, what are your sort of broad expectations quantitatively in terms of Eximo contribution in 2021?

Jim Clemmer, President and CEO

Let me try to get all those, Jason. And I didn't dodge your question, the first one. I just forgot to answer it. So, we're not going to give a commercial structure announcement today as to how many people. We have our internal models that we've built and know will be dedicated. Today Eximo, Jason, has one head of sales in the U.S. who’s handled all the KOL relationships and getting some initial products placed to be utilized by the KOLs. So, there's a supply chain situation. We want to ensure we can supply our customers with, number one, the lasers at the right cadence that we need them; number two, the catheters with the quality levels that we expect at AngioDynamics and the volume levels that we’ve built in our forecast. So, we've got to get those two things built up first. So, we're thinking a deliberate approach towards how we commercialize and market the product. The reason why we're not giving any revenue guidance this year is because we don't think there’ll be much. There may be some merely trailing at the end of our fiscal year. If so, we'll update you during the current year. We're going to take a period of months to make sure we commercialize it properly. So, as we do that, we’ll then provide you with more details around how many people we’re adding and where. The numbers we gave you today that are associated with the adjustment in EPS support what we expect to spend this year on a blend, probably two-thirds commercial, maybe one-third R&D, as Michael identified earlier, but a blend more towards commercial. So, we think that's important. Now, getting back to how we're going to go after the competitive set. Again, we think this technology is really, really unique. And you saw again, by the indications that are granted. We think that's a really strong set of indications. And we agree with you. Above the knee and below the knee are two different areas. We're excited that this technology can address both of those areas. We want to communicate that. So, that's going to be one way the challenge, one way an opportunity for us as to how we do that, Jason. That's why we're being deliberate and measured with our commercial approach to make sure we do these things right. We know our product is really special. We also want to ensure our go-to-market is thoughtful and deliberate. Finally, back to your point of investors having some level of future growth, we agree. And hopefully, you’ll see we've been very transparent about how we're going to do, and what we're going to do. And this follows that pathway where we told the marketplace we want to upgrade our portfolio, do less that are based in commodity and supplies, do more things that are specialized, unique technologies. And that's where we do well. So over time, Jason, we will update revenues that our investors can expect to see. Again, let me remind you, these are very high gross margins based upon especially looking at what we left behind. The NAMIC business was a great business, and Medline bought a great business. But that was a 40% gross margin business with no growth. Today, we're entering something at nearly double that gross margin level, growing at a faster pace. So, we'll update our investors during the course of this fiscal year, as we test our assumptions, build out our plan. If you want to use a rough model and think, hey, three years down, AngioDynamics will probably have 8% to 10% of the market, that's probably in line with our expectations. And we'll give you more detail as we go.

Michael Greiner, Executive Vice President and CFO

And we also anticipate that for the coming four quarters as a standalone product, we will be dilutive. But sometime in the back half of next year, we anticipate we will start to become accretive with this product as a standalone product.

Operator, Operator

Thank you. We'll now be conducting a question-and-answer session. The next question is from Matt Hewitt with Craig-Hallum. Please proceed with your question.

Matt Hewitt, Analyst

First of all, how many of the Eximo devices are currently in use? How many key opinion leaders are using them? And is this base expected to show some traction that can start generating revenue? How should we consider the initial base?

Jim Clemmer, President and CEO

So, fair question. There are less than half a dozen in the field today. And again, one of the reasons why we're being deliberate with our supply chain and commercial rollout is because we want to test. As you know, AngioDynamics has a 30-year history and legacy of product quality; our Company has always had that. We've been trusted and relied upon by our customers for years, and we’re not going to break that. The way that this product was designed at Eximo is impressive. So, it's really important for us to ensure we can communicate how well it works, why it’s so special, but also ensure that it meets our quality levels. So, we're going to be deliberate with our supply chain and quality teams to make sure we get the products made to our specifications and we trust them. When they are, we’ll go to market in a robust fashion. Until then, the products that are in the field today will probably generate a little bit of revenue on catheters, but we're not pushing; we're not having any substantial revenue. If during the coming quarters there's something to talk about, we’ll guide you there, but today, we're not expecting any substantial revenue. We want to ensure we have the supply chain ready. We also have the physician training and sales rep training programs ready. So, when we commercialize, it goes back to Jason's question; there are some good competitors in the space. We think we have the best technology, and we believe our customers are going to adapt to it. But we also got to ensure we’re prepared to enter this market with all of the right things lined up.

Matt Hewitt, Analyst

That's great. That's actually a perfect lead-in; my follow-up question was regarding the training of new physicians. How complex or complicated is that process? Is it something where you would be bringing them into your facilities to train, or would you be sending out dedicated sales people to them? And how quickly can a doctor get trained on the Eximo device? Is it a couple of procedures and they're ready to go, or is it a little bit longer than that? Thank you.

Jim Clemmer, President and CEO

Another good question. So again, we've done extensive field diligence with the Eximo team and their KOLs over the past couple months as we are doing our diligence ties here. We believe we will use a combination of three different aspects: in-house training at AngioDynamics; field training that we’ll set up; and even KOL training at KOL centers around the country. So, we're going to take a three-pronged approach. First, we need to build out what we believe will be the appropriate level of training again for our sales reps and the physicians. The good news for us too is that the people at Eximo did an excellent job establishing KOL relationships with really prestigious individuals, who have seen the value of this technology. Some of those KOLs have already kind of raised their hand and said they'd like to be a part of this process with you. We have networks that exist today from the Eximo side. And don't forget, at AngioDynamics, we sell similar products right alongside and we know many of these KOLs we know these physicians. Some of those folks have probably raised their hand and like to get involved. But again, that's why we're being deliberate and measured with our commercial approach to ensure we do these things right. We know our product is special; we want to make sure our go-to-market is thoughtful and deliberate.

Steve Trowbridge, Executive VP

One thing to add to what Jim said, we're going to put a lot of time into developing our physician training materials and our physician training program. But one of the things that we do think is a real feature of this product is its ease of use. It's very user-friendly. As Jim said, the good thing is, there's already an established market for using laser in atherectomy; we like that. But we also think this product has a level of ease of use that goes even beyond the current systems that are out there. So, it's going to be a very thoughtful, robust program. But, it also comes from a platform that we think isn’t terribly complex.

Operator, Operator

Thank you. I'd now like to turn the call back to Mr. Clemmer for any closing remarks. Mr. Clemmer?

Jim Clemmer, President and CEO

Thanks, Rob. So, this morning, hopefully, you saw that we exited our Q1 in a really good fashion. We have headwinds and tailwinds as every company does in this market. We know where our risks lie; we know where opportunities present themselves. And we’ll work hard during the remainder of this year to maximize what we can do at AngioDynamics. But more importantly, as we transform our Company into a Company with a more robust portfolio that is aligned to physicians who direct care immediately with their talented skills in hands and our amazing products. Adding Eximo today is a really important step in our transformation. This is our fourth deal in 14 months. We’ve acquired three really neat technologies, and we've divested one thing that we think has a better owner than us. So, we've talked to our investors and talked to our employees and our customers in a transparent fashion about our need and our willingness to change our portfolio. And here today, we're proud to announce the Eximo deal as another step towards that transformation. We’re in this for the long run. We're adding technologies that will provide better patient care and better patient outcomes. We believe we're a stronger company today than we were, and we believe we’ll be a better company in the future. Thank you for joining us this morning.

Operator, Operator

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