Good start. Perfect! Well, thank you guys for coming. Really delighted today to be joined with the Axonics team. We have Co-founder and CEO, Ray Cohen, and we have incoming CFO, Kari Keese. Before I get started, just some research disclosures. "For important disclosures, please see the Morgan Stanley Research Disclosure website at www.morganstanley.com/researchdisclosures. If you have any questions, please reach out to your Morgan Stanley sales representative." So getting started, Ray, curious how you're spending your time at the moment. You know, it's been 10 years since co-founding Axonics, so keen to hear how the split of your time has shifted. Well, it's an interesting question. So I think that the focus clearly is always on driving revenue. You know, we've gone through the product development phase, the clinical studies, and all that other stuff, and so we're continuing to add to the sales force. We have over 400 people now in the field in the United States and about 25 people internationally. So you know, you're constantly looking to upgrade, expand incrementally on that team, so I'm involved in that process, continue to be involved in that. So there's that piece where you know, we've made some acquisitions. You know, obviously, Bulkamid has been, you know, very advantageous for the company in many ways, so that's worked out well. We're looking at also how to be more efficient in terms of our direct-to-consumer advertising. And when I talk about efficiency there, I'm talking about the back end of the process. Once we have the qualified leads, how to work them, how to get people appointments, and things like that. So. And then, of course, you know, we're looking for efficiencies in manufacturing and so on and so forth. So I think that, you know, as the company continues to grow and expand, we now have 750 employees in the company. You know, the job does change and does evolve, but in the end of the day, you know, we're growing fast, and so we got to pay attention to, you know, all those details. Absolutely. Q2 performance, pretty solid all around. You know, how would you characterize the key drivers of the performance throughout H1, and how do you think that will change throughout H2? I don't see a change in Q in the second half- Mm-hmm ... of the year. You know, we've provided guidance. We're comfortable with the consensus with numbers in the second half of the year, and things are going quite well. Good. So you know, we believe that we'll continue to, you know, grow this business, in the way that we've described. And there's just a lot of blue sky ahead of us, given the underpenetrated market that we're dealing with. I mean, there are approximately, in terms of moderate to severe patients, whether it's urinary urge incontinence, there's about 20 million folks out there, primarily women, and then on the stress urinary incontinence, there's about another 20 million people, more or less, rounding, that have moderate to severe symptoms and stress urinary incontinence that we can treat with Bulkamid. So, this is a greenfield opportunity for us, and I think that if I had to pick one area that I think is underappreciated by institutional investors, is the size of the market. And, part of the reason is that Medtronic, with sacral neuromodulation, had a monopoly, and they, they held that monopoly for over two decades. And, you know, they kind of milked the cow. They didn't really invest in, in creating awareness or doing any of those kinds of things that you might expect. So you know, we're having to kind of overcome those kinds of things and, you know, just kind of get the word out and let people understand that, you know, just because Medtronic's not growing their business or hasn't in the past, doesn't mean that the opportunity doesn't exist for a market that we believe will be ultimately well over $1 billion in the short term and could be, you know, handfuls of billions as we look into the future. Gotcha. I know typically some seasonality throughout July and August. You know, has that been roughly tracking with what you usually see from a year-to-year basis, or any different trends to call out in the past couple of months? No, I just think that, you know, you look, in July and August, you have more people on vacation- Yeah. ... than you normally would in other months. In our business, given that it's 100% elective procedures, you know, we find that January and February are relatively the worst months of the year. July and August are a little bit slower, and then the other eight months of the year are the time that, you know, you really can make hay. You know, we're now in the fat part of the year. September through the end of December is a really good period of time for the company because people have met their deductibles- Mm-hmm ... or close to meeting their deductibles, and that's a key driver. Because, you know, the average person in America, you know, doesn't have an extra $5,000-$6,000 sitting around in their checking accounts in January or February to undergo these procedures, so they have a tendency to kind of wait. So, but things are moving forward quite nicely. Sounds good. And just wanted to touch on Kari. I know recent announcement of Dan retiring. Maybe walk through the full process and decision-making process to hire Kari into the role. Well, we hired Kari 10 years ago, so please. You want, you asking me or you want her to answer? Ask you, yeah, decision-making- So, look, this is, you know, you have to have succession planning in a company. And, you know, Kari has been with us pretty much from inception at Axonics, and then we had an opportunity to work together in a previous company where Dan, myself, and Kari were involved in a company called Vessix Vascular, where ultimately that was sold to Boston Scientific. So, you know, this is a very logical and an extremely comfortable transition for us to make since Kari's been involved in running finance and accounting since pretty much since day one. Yep, makes sense. Just pivoting now, I guess, onto the current SNM market. Looking at the health of the market in a broader way, you know, how do you feel about your current positioning in the market? You know, any data where you can point to on account penetration in the US? Sure. Well, I mean, we view ourselves as the market leader. It's just statistically we're not there, so we act like the market leader. That's why we're out there creating awareness in the marketplace and doing all the things that we're doing, innovating and providing excellent service for customers. So, you know, but all the growth in sacral neuromodulation at the moment is based on what Axonics is doing. That, that's just the facts as we see them. We're buoyed about growth in the market because we see same-store sales increasing in around 15% on average across all of our accounts. So that gives us a lot of confidence that we can continue to grow this business quite nicely, you know, given the amount of customers that we have in the United States and the fact that they're growing, and doing more procedures than they've done before. You know, a part of that obviously is attributable to us creating this kind of awareness, you know, to let people know it's not normal to leak urine and so forth. Which when you take a step back, and I know I'm a little bit off your question, but when you think about what are the messages that people see on Facebook and on national television, it's all about normalizing leaking urine. It's about normalizing it. Oh, wear my special underwear," "take this drug, and you can dance in the field with flowers, with your girlfriends," and all the rest of it, right? It's all about normalizing it. We're the only company that is actually programming the alternative message: "Hey, this is not normal. There's treatments available to help you so that you can lead a more normal life." But this is the first time in history that anybody's been on the airwaves with this kind of a message. And clearly, with 550,000 people per quarter going to FindRealRelief.com, you can see that there's a lot of interest, and people are really intrigued with the idea to get Axonics therapy, whatever that might mean, because they don't know what that means. Yeah. You know, just based on the commercial, they've got to go and make an inquiry and so forth. So the challenge for us is to get those 6 or 7% of the people that fill out the questionnaire, qualify themselves, tell us about their symptoms, give us their contact information. We want to land as many of those people as we can in doctor's offices, so they can work them up and figure out where they are in the care pathway and ultimately get them treated, whether it's, if it's stress urinary incontinence, let's get them Bulkamid. If they got urge urinary incontinence or fecal incontinence, then let's get them sacral neuromodulation. Because I remember you touched briefly on your Q2 call about a kind of a new campaign. Can you maybe talk to us about, you know, which audience you're going to be targeting here and the message you're trying to convey? Well, it's the same audience. What we're doing is we're freshening up the messages. We've got three or four new commercials that will be running shortly, certainly in the fall here. For the first time, there's an actual... By the way, we only use actual patients. We don't, you know, have actors on television. So we have actual patients who volunteered to do this. So for the first time, we have a gentleman who'll be talking about fecal incontinence and the fact that, you know, he had this condition, it was debilitating, he found Axonics, he got treated, and he's got his life back. So that's going to be really interesting to see. We also have a commercial for the first time where we'll actually say the word Bulkamid. So in other words, it's going to be a woman who's had a couple of children, talking about, you know, post having these children, how when she laughed or lifted or exercised, she was leaking. And then she found Axonics, got Bulkamid, and, you know, now she's dry. So, you know, and we'll continue to run the kind of generic overactive bladder commercials as well. So we're going to experiment with a little more specific messaging, to see, you know, how that works and so on and so forth. I'm really curious, in particular, on the fecal incontinence side, because what we found is that about a third of our urge urinary incontinence patients have fecal incontinence, but they're shy about admitting it. I'd say only about half of them will admit they have this problem, and then the other half will tell you how well their bowel function improved after they get treated. So that tells us that, you know, this is as big of a problem as the clinical literature suggests. So we're going to try to see if we can get these people to raise their hands and come out of the woodwork, and so we can get them help. Do you have any stats maybe about the conversion over from people that have seen the campaign and then clicked on it, and then who's actually getting the treatment itself? You want to comment? I'll comment. You want to comment? You go. Okay. So here, here's what we've said. When we were asked about these commercials and the uptake and all that in 2022, the answer was, "Look, it's way too early. You know, we think it's going to take about a year before we could start to see people get through the care pathway and get procedures done." But in real time now, what we're seeing is twice as many dollars are coming back to the company than we're spending. Okay, it's taken 18 months for us to get to this point, but so this is very encouraging. Mm-hmm. So we are seeing people get implants. Every single month, more implants are being done as a result of DTC, and we have the ability to track very specifically because we know when you responded, we know who you are, we have your contact information. And then when you get implanted, we know who you are, and we just match the names. And so this is not speculation. I'm not speculating. This is a name-to-name, you know, tracking that we're doing, and we're extremely encouraged by this, so that's why we're gonna continue to plow forward. Now, we're not gonna spend incrementally much more money, and the reason for that is that it's difficult to manage 30,000 or 40,000 individuals who filled out a symptom survey and to try to work those people and get them appointments. So we want to do justice to those people who respond. We could generate many, many more leads, but then we're just gonna, you know, we're not gonna be able to do justice to those people. Mm-hmm. We are working on perfecting and optimizing, maybe that's the better word, optimizing the process of, you know, if Miss Keese responds to us and says, "Yeah, here's my information, I'm a moderate-to-severe candidate," I really wanna, you know, get her placed or whoever it might be, get them placed with a physician. So that's the key. Gotcha. Just curious what you're seeing out there in terms of drug development in OAB. You know, any other second-line products that you think could pose a threat to your patient funnel? We're tracking some of the Gemtesa sales growth, and it seems to be pretty rapid. So just curious to your thoughts there. So look, drugs don't work very well for patients who have moderate to severe incontinence. Plus, I mean, so simple as that. So right now, the guidelines say that you've got to try a drug and, you know, before you're qualified to move on to sacral neuromodulation. So, I think, look, the more activity there is in this area, whether it would be drugs, devices, peanut butter, whatever it is, this just is gonna help to float more boats, right? So we're, we think it's fine, and it, it's irrelevant, right, what drug people take that isn't gonna help them eliminate their symptoms. It's just part of the fabric of what we're up to. You know, Valencia had approval for the ITNS technology last year. You had BlueWind recently come through with approval. Now, what have you heard from docs on these devices? Any feedback you can share with us, and then how are you viewing these devices internally? So, you know, this topic of implantable tibial nerve stimulation has been in play now for longer than Axonics has existed as a company. So these companies that you're referring to, they were all founded and all started way before Axonics. Mm-hmm. And the fact is that, you know, we're not believers that stimulating in the ankle is the right neural target. You don't get the same efficacy, and embodiment matters. So the Valencia product is not being favorably viewed because it's a device you put in the ankle, self-contained. It lasts 1-2 years, and I'm being kind by saying 2. Okay? So what—in what world does that make any sense? I mean, it's completely illogical. So there's been no impact from that, and then the reimbursement has been a head scratcher. And, you know, starting in 2024, there will be no physician reimbursement. These devices will have a Category III code, which means that they've got 3-5 years of dealing with private insurance companies trying to get coverage for their products. So, we just don't see this as a threat to the business. I think the BlueWind embodiment is better, but it does require then that somebody has to wear a cuff around their ankle for, you know, a couple of times per day for maybe up to an hour in order to get any efficacy. And the one thing that I've learned in being in this business in 42 years is that humans want the following three things if they have a medical condition. One, they want their problem fixed, meaning they want efficacy. Two, they want longevity of treatment or effective treatment. Three, they want to do nothing. Okay, that's the human condition. So we have products that fit exactly in that, in that domain. So I just don't see how people will be adherent to a protocol which requires them to do something every day for the rest of their life. So, you know, I wish them all good luck, and I don't see it as a negative. I think, once again, more, you're gonna see more and more activity in this field because we've shined a light on this huge opportunity, and I think people are gonna try to come up with all different kinds of things that they could possibly do to get into the business, whether it be stress or in incontinence- Yeah ... side or on OAB. At least from our doc conversations, I guess one of the biggest, you know, the biggest challenges of convincing a patient is that invasiveness of the procedure. So how are you going about encouraging patients to get the implant? Well, you know, we can only highlight, you know, the problem and get them to come to the physician's office. It's the physician's job- Mm-hmm ... to communicate with the patient about what it is. And I want to dissuade you of that view that you just suggested that we have an invasive product. I mean, the entire, if you take a scalpel, you make an incision that's this big. Mm-hmm. Okay? You place the IPG in a pocket there. Okay, you know, we drop a lead down through your sacrum. It's not very invasive at all. It's a very fast procedure. It's a day case. Patients, a day case, that's U.K. parlance, right? You know, patients come in, it's like a colonoscopy, right? So you're in there, you get propofol, maybe a little Versed, and, you know, you're out the door within an hour or 2 hours. The whole procedure is maybe 15 or 20 minutes. So this is not a big deal for physicians and nor for patients. Mm-hmm. Anybody thinks, you know, if you refer to sacral neuromodulation as, "Oh my God, this is an invasive therapy, a big deal," it's just a story that's being made up by people who want to compete. Okay. In my view. Pivoting on to Bulkamid, you know, becoming a really nice revenue driver now, what's the big picture plan for this asset, and how far do you think it can go? I really like that question. You know, when we first acquired the asset, you know, we suggested that we thought we could do $50 million of business by the end of 2024. You know, a consensus here in 2023 puts it at around $73 million. I think we've just scratched the surface. We've got a lot of accounts that are doing Bulkamid right now. And I think we've got a product line that could do hundreds of millions of dollars. So we're really excited about that product. And more importantly, you know, the patient satisfaction is through the roof on this product because they come in, and they get these injections, and it's done very quickly, and they're dry immediately, right? There's no, there's no recovery, there's no side effects. It's just like, man, they come in, and they, they're wet, and they leave, and they're dry, and they're happy. And, and they go home, and they tell all their girlfriends about it. And, you know, doctors get satisfied patients, and they get referrals. And, and I think this concept of a satisfied patient, who, who wants to give you referrals is like a old concept, that, you know, it's like, "Oh, wow, this is, this is a really cool product," right? "It not only works, I get my patient treated." So they get to treat more patients because in the past, the only option for these patients was a sling operation. And, most patients said no to that. Having said that... We're talking about 20 million women who have moderate to severe symptoms in this category. In the past, they weren't that keen on slings. And then, of course, with the mesh controversy, you know, that also impacted that as well. But about 350,000 women got slings in 2015. And that was the drop in the bucket compared to the people, how many, you know, millions are out there. So you can see that we think that this product line has a long way to go and a lot of legs, and there's no reason why ultimately, over time, we can't be treating hundreds of thousands of people with this product. So the first thing was we got to get people trained, and you got to get the product in their hands and all that. You know, we got control of this asset in effect in March, April 2021. So it's been a relatively short period of time, but we've made enormous progress with the product. The word's out that you know we got a great alternative, and the physicians are really excited and satisfied that they can treat more patients. That's the other key, right? They're able to get people that wanna. You know, they say yes to the offering, and they get to treat more patients than they would in the past. Sure. Do you have any, like, market share data on that? You know, where- Yeah. ... Bulkamid's positioned? Yeah, we have, according to claims data, somewhere in the neighborhood of 80%-85% of the market. So we basically have obliterated any other bulking agents that are out there. They're not in favor at this point. Ultimately, we'll switch that topic to market share for treatment. So in other words, we'll compare ourselves with respect to slings as well and talk about it, but we're not quite there yet in terms of, you know, having solid data because that sling business is declining, and every patient that gets Bulkamid is one less sling that gets done. Sure. Just remind us of the competitors in, in that business, if that's okay. In the sling? Uh, yeah. Boston Scientific, Coloplast, and Caldera. Those are the three players in that market. Cool. So a lot of our incoming now focus on GLP-1s. Now, how have you been thinking about the longer-term impact here on the patient population suffering from urinary incontinence? It's not. There's no direct correlation there, so let's leave it at that. No. We've seen a few studies that have, you know, some fairly robust data indicating some correlation. So have you not, you know, thought about the longer-term picture and maybe how the patient funnel could change there? No. No? I mean, if you press me, I'll make a few more comments- We will get- ... about the GLP-1, but everybody's asking that question. I mean, I think that any management team who's not in the GLP-1 business is gonna say the same thing, which is it's too early to make a determination on how long or how many of these patients will stay on this drug. But I can tell you that Sacral Neuromodulation, we believe, can treat constipation, which is one of the side effects or it's the mechanism of action, actually, of a GLP-1. So we have a study that we expect to be doing in 2024 to get approval for treating chronic constipation. So in some bizarre way, GLP-1s may actually add to our business. Okay, promising. Just pivoting on to profitability now. So solid EBITDA result in Q2. Now, how are you planning on extending these margins whilst investing enough to keep growth, you know, ahead of the market there? Sure. Our philosophy on this is that we are investing in our growth and not holding back on investments. What you're seeing in our financials, highlighted in Q2, is the strong natural operating leverage that we have in our business model. So we would expect that trend to continue in 2024 and beyond, as we expect revenue growth to outpace the growth in OpEx. Okay. Aside from the DTC campaign, you know, any areas of investment you want to highlight? Well, I mean, we're making investments. I mean, we just leased 150,000 sq ft of facility space to increase our manufacturing footprint so that we're better prepared for 2025, right? In terms of being able to build product. But that's a balance sheet item, right, so there's some CapEx investment there. We're gonna run some clinical studies, you know, to look at expanding some of the indications, or to get F15 approved, as an example, in Europe, now with the new guidelines from the MDR and so on and so forth. So there's some... But this is a steady state. Like, we don't anticipate any dramatic increase, you know, in OpEx per se to do these kinds of things. Okay. And just touching it briefly, the international side of the business, I think you have 25 field-based personnel out there now. You know, which areas are you gonna be targeting specifically outside of the U.S.? We're keen on Australia. Yep. That was a new market for us. It's a little bit more of a laissez-faire healthcare system, so there's a bit of a pretty decent opportunity there. So things are going quite well down under. You know, in a lot of these other markets, those international markets, you have, they're capped, you know, in terms of the amount of money that the government would spend. You know, your home country is probably the worst of them all, in terms of, you know, having dollars and getting people access to advanced therapies. So that's why our footprint is pretty light internationally, given the way the reimbursement systems work. But, you know, it's a growth opportunity for the company. We think that we can do better than we're currently doing, once we get F15 approved in these foreign markets. Okay. Sounds good. Final question from me. Now, what's something about the Axonics story that you wish more investors would focus on? I think people really should, you know, it’s this notion that we carry this baggage on our back, which is the Medtronic legacy. And because Medtronic had not grown the business over the arc of time, okay, when we entered, it was a $500 million market in the United States. But I think that you know, we’ve had to kind of overcome that perception, that somehow the markets are not as big and untapped as they are, and that’s the piece that we try to really get across. And I think that the response to our DTC really, you know, kind of double underscores the fact there’s a lot of folks out there looking for solutions to incontinence. So I think that’s the number one thing. I mean, we see this as an unbelievable. It's a greenfield opportunity. And our TAM is, I dare say, larger than most every other... Maybe not as large as GLP-1, but it's larger than most other med devices that are out there. Perfect. Yeah. Well, Ray, Carrie, thank you so much. Pleasure. Thank you for your time. Thank you, everyone, for joining as well. Yeah, look forward to spending more time with you soon. You bet.