All right, I think we are live here, so we'll get started. My name is Adam Maeder. I'm one of the Medt ech Research Analysts here at Piper Sandler. Very pleased to introduce the management team from Axonics. With us, we have Ray Cohen, CEO and President, and Kari Keese, CFO. Guys, thanks so much for joining us. Thank you. Maybe to start, wanted to just touch on Q3 and the implied Q4 guidance. So Q3 was a nice beat and raise quarter. The implied Q4 guide, I have at $105.4 million, or about 23% growth year-over-year, 13% sequential growth, quarter-over-quarter. Can you talk a little bit more about the guidance construction? I mean, I know the numbers are getting bigger, it's a tough comp, but you sequentially had a larger step up Q3 to Q4 last year. So maybe it's just conservatism, Ray and Kari, but just anything you wanna talk about with the guidance construction as well as Q4 to date? So it's not conservatism. I think the comp is informed also by how well we did in Q4 last year, right? Sure. So Q4 is our biggest quarter of the year. This is gonna be the first time where Axonics is gonna do more than $100 million in a quarter. So this is a major milestone for the company. And, you know, our projections, whether it be internal or until ultimately becomes what we communicate publicly, are all built from the ground floor. And, you know, we're, you know, pretty specific about doing things on a kinda customer by customer, territory by territory, rep by rep basis. That's how we build it up. You know, it would be foolish for me to be talking publicly about numbers that, you know, people haven't bought into throughout the organization, so. Sure. You know, I'll test my luck here. Anything you wanna comment in terms of the quarter playing out relative to- You know, I'm not gonna speak to that. All right. Well, How's it going? It's going. Yeah, it's going. Okay. Yeah, every day- All right ... every day, you know? Sounds good. So let's step back and unpack the performance year to date a little bit. The execution has been strong again this year. It sounds like a lot of the performance has been driven by same-store sales growth. So would love to hear a little bit more about kind of the growth algorithm, same-store sales versus new accounts. What does that look like this year? How do you envision that in 2024? Sure. You wanna talk about that? Go ahead. Okay. So, our business is obviously we're growing, and, you know, if I just round down to 30%, right? How do you get that 30% growth? And for us, half of it comes from increases in existing customers. So same-store sales, right? That's the big driver. Obviously, that speaks to growth in the market, and then the rest of it comes from, obviously, new account acquisition. You know, I think everybody knows that for Sacral Neuromodulation, we're competing, you know, with Medtronic, who had a 25-year head start on us and a monopoly in the marketplace. So by definition, you know, we're bringing those customers that had only one choice before. Now they have choice, we have competition, and, you know, they're coming to Axonics in large numbers. You know, we're gonna continue to pick up those accounts, and that will contribute to growth in the business. But we're encouraged by the increases in uptake from existing customers, right? If that wasn't the case, then we, you know, that's a red flag. But that's going really, really well, and I think really underscores the opportunity that we have in terms of the total addressable market, and how really untapped this is, and the fact that we've got literally tens of millions of patients or people out there that are not patients yet, that are suffering in silence, and that still don't know that it's not normal to have incontinence, right? This is not normal. I mean, a lot of messages that are trying to normalize that, you know, which... and you'll get to DTC, but this is part of the reason why we've actually gone to Facebook and the airwaves, to kinda get that communication out, to let people know that there are solutions, there are advanced therapies that we can help resolve this problem for you and have a better quality of life. And so that's what we're up to. But it's been an exciting journey, right? I mean, we're gonna finish our fourth year as a commercial company, and it's gone amazingly well for us, and we're bullish about the future. That's great to hear and great color there, Ray. I have to try my hand at 2024 now. I hope you understand. So I have pre-call consensus at $442 million. I think that's 22% growth year-over-year. Any reaction to that figure? Yeah, I mean, look, we think we can do $1 billion next... I'm just kidding. That's right. It's like, write that down. So, look, we're comfortable with consensus for 2024. I think that's the fairest thing that we can say. And, so Sure. No, appreciate that, and, you know, I'll ask for puts and takes as well, from you, Kari, and just, you know, any kind of color you wanna provide on Sacral or Bulkamid, just things we should be thinking about in models, growth levers, et cetera? No, I think so, so far, you know, I think folks have externally are paying attention, and I think we've seen, you know, reasonable comments from the analyst community, including yourself, obviously, which we appreciate. But we have 14 analysts covering the company now, right? So there, there's a lot of opinions out there about what's going on or what we're doing and so forth. But things are going well, and we don't see this growth train stopping. Okay, perfect. Let's talk about leverage, because the leverage piece is really starting to come to fruition. I think it's an underappreciated part of your story still. You know, I have the street modeling 15.1% Adjusted EBITDA margin for full year 2024. I think you did 15% in Q3, you did 20% in Q2 of this year. The question is: how do we think about Adjusted EBITDA margin trajectory in future quarters, and where can this go over the next one to two years? And really, what are the levers, Kari, that are driving this? Yeah, we're certainly pleased with the performance we've seen so far. Our revenue growth is well in excess of our OpEx growth, as you pointed out. We do expect this trend will continue in 2024 and beyond. I think there's multiple drivers of future leverage for us. We know we can improve our gross margins. We believe we can continue to increase sales rep productivity, and we believe we can increase sales without a proportionate increase in SG&A, et cetera. Where can we go from here? Obviously, we haven't given 2024 formal guidance, but we model, you know, an EBITDA margin in the mid-teens in 2024, up to high teens in 2025, is, you know, a good balance for us to be able to invest in the business, grow the business, while still being efficient with profitability in mind. That's great color. Thank you for that. I wanted to jump back and talk about the sacral business. And, you know, you, Ray, I think you've previously outlined an algorithm for Axonics directional sacral neuromodulation growth of 25%. And I believe the construction is a couple hundred basis points a share gain, a broader market growing in the mid-teens. You know, sometimes I kind of, people don't necessarily question the 25%, but people wonder if maybe it's a little bit more heavy-handed on share capture versus market growth. You know, I guess, what's your response to that? And, So look- Why is it the right? Okay. So look, the reality is that when we started to talk about this four years ago, a mid-teens growth, we made an assumption that our competitor would continue to grow their business, okay? They don't seem to be interested, which is okay with us, right? But that shouldn't be held against us. If we're growing better than 30%, but we only have, I'm going to round up to 40% of the market, and then the party that has 60% is -2%, you know, the math doesn't come out to mid-teens in terms of overall growth in the market. So my specific comment is, we're doing our part. We're doing more than our part, okay? We have 250,000 people per month going to findrealrelief.com, inquiring about what is this advanced therapy to solve my incontinence problem? I mean, that's unbelievable, right? And I think just underscores the fact that there's literally tens of millions of people, primarily women, who are out there suffering with these conditions. So, you know, you know, it's weird to be rooting for your competitor so that the numbers kind of work out better on somebody's spreadsheet. But the reality is, despite the fact that they're flat, we're growing leaps and bounds, and we're going to continue to do that. And I want to comment this comment about share, and I understand it's a general statement that everybody makes. But share, in my mind, and market share, is when you have a definitive. There's definitive amount of money to be spent, and there's budgets. Okay, and you're all fighting over a certain slice of that pie. We're in a completely different situation. This is a greenfield opportunity with tens of millions of people that are out there suffering. And so, you know, when we talk about increases in revenue, it's coming from the fact that we're doing something to, no pun intended, stimulate the marketplace, right? And let people know that, you know, there are solutions to these problems. So, I don't see this abating anytime soon. I mean, if we took. If every one of the accounts that currently works with our competitor came to Axonics, we're still going to grow, right? You'd say, "Oh, we have a 100% share." But okay, then the question is: How are we growing the pie, right? And, and, and so forth. So, so we're doing a lot of things on an individual practice basis. I mean, you know, there's all kinds of initiatives to try to help these physicians who are busy, you know, get more patients to these therapies. And, and, and they—because right now there are hundreds, if not thousands of patients, that are walking in the door of every urology practice in America, and they're walking back out the door without having had a discussion around advanced therapies. They're busy and so on and so forth. So it's incumbent on us to provide tools and ways for them to be able to communicate more effectively with these potential patients, so that they don't just get a drug script and then for moderate to severe incontinence, which won't work, right, if you have urge urinary incontinence. Or you pitch them on a sling operation for a woman who has stress urinary incontinence, and the answer is: "No, thank you. I don't want the surgical intervention." But they don't bring up Bulkamid as an alternative. So you can see, we have a lot of work to do to say, "Look, these are great products today." Sacral neuromodulation. These are technologies that now can live in somebody's body for 20 years plus, okay? This is not four years ago. Imagine, you had a device that lasted 4-5 years in somebody's body, was fussy, and the reality is it wasn't MRI compatible. Who's going to say yes to that? And the same thing about slings, right? You know, slings, there are, right now, 19 million women who have moderate to severe stress urinary incontinence, and the apex of slings was 350,000 procedures in 2015, and that is down approximately 30% today of what it was. What is that about? Well, that's not what women want, okay? That's why Bulkamid has captured the attention of so many women across the not only America, but around the world. So, you know, in the end of the day, you have to offer solutions to patients that make sense, that people are willing to say yes to. And that was not the case, either for stress urinary incontinence or for urge urinary incontinence or fecal incontinence previously. And the last word I'll say about that, and I think the other travesty, is that too many people are getting Botox. You know, you, you've got some wrinkles? Okay, fine. Stick some Botox in your forehead. Great, that'll last for a period of time or whatever. Everybody understands that. But putting Botox in your bladder so that you can treat urinary urge incontinence for 4-6 months, subject yourself to approximately 15% urinary tract infections, and then do this repetitively, it doesn't cure anything, right? So that's a big issue. Right now, today, still about 150,000 patients in America are getting Botox. So that doesn't make any sense. You have a chronic condition, and you're providing a short-term solution, and you can imagine the conversations that we have with, with, with the caregivers about that. Like, "Why, why are you doing that?" "Oh, well, it's easy." Okay, great. You know, is that the best solution for your patient? Obviously not. So anyway, you can see I'm a bit of an evangelist about- Sure these things because it just... You're trying to match things, right? If you have a chronic condition, you want a chronic—if you, you want a chronic condition, you want a long-term solution. And, and we're trying to get that message across, to, to, the marketplace in general, these physicians, that what Axonics is offering today is not your grandfather's, products, okay? These are modern technologies that are easy to use, that patients are doing amazingly well with, with high levels of satisfaction. So, you know, it's kinda like, "Hey, if you're interested, you wanna treat more patients, you wanna have happier, patients, work with Axonics." That's our pitch. Very fulsome response. No, that's good. I appreciate the color. Wanted to follow on to your Botox comment. I think you previously said Botox is your largest competitor. So multi-part question. I guess the first is, how much of your sacral volume is comprised of patients that had previously received Botox versus patients that are new to third-line therapy? And Ray, what do you think the bigger barrier is to tapping into these patients? Is it the physician or is it patient education? So I think it's multifaceted, is the second part of your answer. It has to be both. You need to get the physicians on board, but you gotta let people know, right? You gotta let people know in general so that they're asking the right questions. And I think it's just gonna take some time, right? I mean, things don't change, you know, overnight, and you know, we've only been at this for four years. So I think, you know, we'll continue to see more uptake for sacral neuromodulation and less uptake for Botox over time, but it's gonna take. It's just gonna take more time. Okay. One more on the sacral side, and I think it's an account-related question. I think you've talked about 4,000 physicians that are doing sacral procedures in the US. Obviously, not all are Axonics customers, but when I look at kind of your offering, you have the edge on technology, you have the edge on data, you're doing the direct to consumer, you have a broader portfolio with Bulkamid. So, you know, what are the roadblocks here? You got better salespeople- Okay. You got more clinical specialists. Didn't mean to sell you short. No, no. But what are the barriers right now and, you know, how do you break through with these other accounts? You know, look, I just think it's... You know, we're overcoming a perception amongst the urology community that sacral neuromodulation is a therapy of last resort. Okay, that's the way they viewed it for over two decades. And so when you're trying to create a sea change in terms of, you know, the how people view something, a new category, or a new technology in a category, it just you have to continue to kind of beat those messages and get those across. So I don't think there's any magic trick or some magic bullet that we're gonna employ. Look, I think the DTC was a smart decision for the company. We've invested wisely. We're getting a return on that investment, and it's created halo effect for Axonics. Imagine, here we are, the new entrant in the market, and we're out there, you know, creating this level of interest amongst the, the, you know, general population. Whereas the incumbent, who happens to be, if not the largest, one of the largest companies on the planet in medical devices, never, never did anything. So, we get a lot of credit for that, and now that halo effect is turning into real people getting procedures and, and, and, you know, and, and, and having a better quality of life as a result. So I think it's kind of a full circle concept. So we're just gonna keep, you know, doing what we've been doing. And, you know, part of it is, you know, expanding the team, right? So we have approximately 440 people in the United States that are out there. Half are salespeople, quota-carrying, and the other half are support, clinical support people. So we've got more feet on the street. You know, we're on the airwaves. We're doing a lot of these things, and I think that we have a winning hand, and we just need to play it out. That's helpful. Let's, I guess, let's stick with DTC. Kari, can you just remind us the level of DTC spend in 2023, kinda how that's trending for this year, and how do you envision the level of spend in 2024? 2023 is expected to be high teens, $17 million-$18 million. We expect similar- That includes all marketing, not just the specific DTC. I wanna clarify that- Sure. But keep going, please. Similar spend in 2024 on DTC and related activities. As Ray mentioned, in recent months, we're seeing, you know, gross profit dollars from implants generated from the DTC campaign exceed our investment. Since we're getting better at targeting our ads, we expect the interest generated will compound over time. You know, the same level of spend, you know, we'll generate more lead generation and convert to more implants. It takes a while, and we started this in April of 2022, right? So we're—you know, now here we are. And what we've seen is that the repetitive nature of these ads, whether it's Facebook, whether it's on national television, is now starting to yield the actual implant results, right? So we hypothesized initially, you probably remember we talked about this, that it might take a year if, when somebody raises their hand, fills out a survey, tells us who they are, says they're interested in an appointment, before they're actually, you know, ready for an implant, particularly if they've never taken a drug. Because part of this process for reimbursement and all the rest is they have to try and fail a drug first before you're eligible for third-line therapy. So there is some time that has to go by. So obviously, you know, when somebody raises their hand and says, "Oh, I've taken a drug, it really didn't work for me, and I'm interested in what you're doing," that's the hot lead, if you may, and those are the ones we're gonna focus attention on. But the high-water mark for us was in October. We have more implants from DTC in October 2023 than we did in September and all the months prior, and it just continues to move in the right direction. So, this will continue to pay dividends for us, and I think that was Kari's point for time in the future. In other words, you know, we're making these investments, but they're, but they're yielding dividends for us over the horizon. And so it makes sense, and we, we want to continue to, continue to invest there. Great. But I want to point out, this is not the driver of our revenue, okay? Because I get this question sometimes from fund managers. You know, this accounts less than 10% of our revenue comes from our DTC efforts, right? It's everything else that we're doing that is driving the revenue forward. So I don't want to give people the impression that it's this particular spend that is what is driving our business, because that's not correct. Sure. So we have less than five minutes left, and want to talk Bulkamid and one question on competition. But just to close the book on DTC, I think you were, you know, doing some modest changes to the commercials and, you know, messages. Hopefully, that's accurate. Are you pleased with the initial results? Anything you can say there? Well, we have five new commercials running. For the first time ever in history, there is a patient, a person who is one of our patients. By the way, we don't employ actors. These are all volunteer patients who is admitting that he has fecal incontinence. Okay? That's the first time ever that anybody ever admitted this, especially now on national television. So we have new commercials. We're getting a little more specific. We actually have one commercial with a woman who's in her thirties, who's had a couple of children, and has stress urinary incontinence, and so she talks about her experience. And then her mom, as it turns out, also got Bulkamid. And so there's a commercial with both the mom and the woman together. So it's kind of... It's cool, it's fun and all that. But then the highlight of all was, of course, our commercials on The Golden Bachelor. You know, talk about, that's our demographic, man. Okay. You know, come on, you know? So, it's working well. The ads are pulling, but it's hard to determine, are the ads pulling better now because the messages are a little more specific, or is it just because of the redundancy of it? In other words, right, people keep seeing these over and over again. And I think it's some combination of both, of course. Sure. So I have to ask the prerequisite question on competition. So, you know, looking ahead to 2024, I can get... This is more on the sacral side, any new competitive dynamics that are worth calling out here? There's obviously been some noise with the tibial players among the Wall Street community. You know, what impact, if any, do you think you'll see from competition next year? I'm gonna save time. None. Anything else you want to add to that? Okay. We'll keep so feeling pretty good about the business from a competitive- There's no reimbursement for ITNS. I mean, you... If you're a doctor, you know, you're not gonna get paid for doing it, and there's no private insurance reimbursement, and they've got Category Three codes, and it's gonna take years for this to come to fruition. So good luck, God bless you, and all the rest. But I... But my answer is still the same. It's not, and it has no impact on our business in the short term. Perfect. Let's talk Bulkamid here. You know, that's been a fantastic acquisition, fantastic add to the portfolio. I think your guidance this year is for 70,000 Bulkamid procedures. This is a massive market. Ray, maybe just frame the market opportunity and where can this go over the next two to three years? Well, look, I mentioned earlier a 350,000 sling operation statistic from 2015. So there's no reason why Bulkamid cannot surpass that number on an annual basis over time. We, the one thing that I think I can safely say is that we expect by the end of 2024 to exit Q4 at a $100 million ramp, and that's 100,000+ patients. So I think that's the expectation that we have, far exceeds the first time we ever had this conversation. We were thinking, "Man, if we could sell $50 million of this in a year, this is gonna be unbelievable." But, you know, now we're looking at, you know, 100+, and I think sky's the limit for this. And we have literally thousands of customers now that are actually injecting Bulkamid, so... They just keep coming. So this is a phenomenon that, you know, has turned out far exceeded our expectation. But I want to make one, one comment, that we would not have been successful with Bulkamid, a product that we only get about $1,000 per treatment. We would not be successful as a company with this product if we didn't have the infrastructure, and we weren't in the sacral neuromodulation business. So it's kind of hand in glove, and, and that, that's where the, really the synergy has, has, has played out. Very helpful. Just one last question, keep it on Bulkamid. The GYN opportunity, is this something you're still focused on for 2024? And then I guess the other question would be on Bulkamid reimbursement. I think there was some optimism at one point in time that that might get more favorable next year. I'm just curious if that materialized. So we don't have the numbers yet for 2024 for Bulkamid, for the material, okay? What patients, what docs get paid for doing the procedure is known right now, but we're waiting because it's strange, it's a DME code, so we're waiting for that. We're optimistic that will increase, but we've seen increases in the reimbursement for the material since we started a couple of years ago. So that, we expect that will continue. I lost the first part of the- The GYN. Yeah. Look, we're out there, and the word's, you know, continuing to spread, and we're pretty agnostic. I mean, if you're a gynecologist, a urologist, or OBGYN who's not dropping babies anymore, then, you know, we're happy to work with you. And once again, that customer mix will continue to evolve over time. So, I think that's a fair statement. And I know we're out of time. Perfect. Well, now, always a pleasure. Thanks so much, Ray and Kari. Thank you ... for being here. Pleasure. Appreciate it.
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