Good day, thank you for standing by. Welcome to the Axonics' Q2 2023 results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You'll hear an automated message, your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I want to hand the conference over to your speaker today, Neil Bhalodkar. Please go ahead. Thanks, Victor. Good afternoon, thank you for joining Axonics' Q2 2023 results conference call. Presenting on today's call are Raymond Cohen, Chief Executive Officer, and Dan Dearen, President and Chief Financial Officer. Before we begin, I would like to remind listeners that statements made on this conference call that relate to future plans, events, prospects, or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 995. While these forward-looking statements are based on management's current expectations and beliefs, these statements are subject to a number of risks, uncertainties, assumptions, and other factors that could cause results to differ materially from the expectations expressed on this conference call. These risks and uncertainties are disclosed in more detail in Axonics' filings with the Securities and Exchange Commission, all of which are available online at www.sec.gov. Listeners are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date, July 27th, 2023. Except as required by law, Axonics undertakes no obligation to update or revise any forward-looking statements to reflect new information, circumstances, or anticipated events that may arise. With that, I'd now like to turn the call over to Ray. Thanks, Neil. I'd like to welcome everyone joining this afternoon's call. With strong company-wide execution, Axonics generated record results in the Q2. Revenue was $92.9 million in the Q2, an overall increase of 35% compared to the prior-year period. More specifically, Sacral Neuromodulation revenue was $74.2 million, an increase of 33% compared to the prior-year period. We are particularly proud of this level of growth, considering this is the Q1 in which we anniversary last year's launch of the F15 Recharge-Free System, which is currently our top-selling SNM system. Revenue growth is being driven by a combination of higher utilization and share of wallet in existing accounts, as well as the addition of competitive accounts that have converted to Axonics. Internationally, our SNM revenue grew by over 50% compared to last year, as a result of a measurable contribution from our recently deployed direct sales force in Australia. Bulkamid revenue was $18.7 million, an increase of 41% compared to the prior year period. Results were driven by increasing reorder rates from existing accounts, the onboarding of new accounts, and the addition of new sales reps, primarily focused on promoting Bulkamid. Our gross margin in the quarter was 75.6%, up from 72.8% in the prior year period. The most exciting news for us is that we generated over $18 million of adjusted EBITDA in the quarter as we continue to benefit from the operating leverage inherent in our business model. Dan will discuss our margin expectations and financial performance outlook in further detail in his prepared remarks. I would now like to provide several other corporate updates. On the reimbursement front, CMS recently published proposed Medicare payment rates that will take effect in the calendar year 2024. In summary, the proposal includes S&M facility fees that would increase by 1.5% in surgery centers and be flattish in hospital outpatient departments. As for physician fees, while the conversion factor was down 3.4% across the board for all specialties, physicians performing sacral neuromodulation would actually see an increase due to the work RVUs increasing for implanting the neural stimulator. More specifically, physicians performing an external trial with a PNE in their office, followed by a full implant in a facility, would see a 50 basis point increase in reimbursement under the proposal, while physicians who perform an advanced trial in a facility, followed by an implant, would see a 23% increase in reimbursement. Our commercial team currently accounts for nearly 60% of Axonics' 725 person full-time employee headcount. We have approximately 400 commercial team members in the United States, of which 185 are directly involved in selling or sales management, with the balance of the personnel being field clinical specialists, field marketing specialists, and remote therapy support specialists. Internationally, we now have approximately 25 field-based personnel, they're located in Western Europe and Australia. We are well staffed at this time and expect only a modest increase in our commercial team headcount for the balance of 2023. Turning to the Axonics Find Real Relief direct-to-consumer advertising campaign, we continue to generate more than 10,000 qualified leads each month. A qualified lead is those individuals that complete a symptom questionnaire on our website, telling us about their symptoms and providing contact information. In addition, many of our customers tell us that patients come into their practice asking about Axonics therapy after seeing our ads on television or on the internet. The campaign continues to generate goodwill within our physician customers, as they are grateful that we are helping to ensure that adults with these conditions are seen by a clinician and advancing along the care pathway. We continue to note that over half of the individuals filling out these questionnaires are treatment naive, underscoring the notion that people don't know that it's not a normal part of aging to leak urine, and that advanced therapies exist to treat incontinence. Our call center continues to work diligently to connect qualified leads with a physician specialist in their local community. It's been about 18 months since the launch of the DTC program, and as we anticipated, it is yielding measurable SNM and Bulkamid revenue and an encouraging return on investment. Given the success of the DTC program, we are in the process of launching new commercials related to the conditions of stress urinary incontinence, which is served by Bulkamid, or fecal incontinence, which is part of our SNM system, in the second half of this year. Turning to the IP lawsuit with our competitor, we will limit our comments on this topic to the following. As we have previously said and continue to maintain, we do not believe that Axonics infringes on any of our competitor's patents, and this case is simply litigation to create a financial and legal burden on Axonics in an attempt to slow down our market penetration. Recently, the United States Court of Appeals for the Federal Circuit reversed the decision of the PTAB that the tined lead patents asserted against Axonics were valid, finding instead that the PTAB committed legal errors in its analysis. The Federal Circuit remanded the matter to the PTAB for another review, consistent with its opinion and direction. Now, there are a few more patents under review by the Federal Circuit, and we anticipate that the appeals court decision will be forthcoming in a couple of weeks. Because of these developments, the U.S. District Court for the Central District of California issued a stay on the litigation proceedings pending the outcome of the proceedings before the PTAB. As a result, the jury trial previously scheduled for August has been postponed indefinitely. Now, turning to product development initiatives. We're making really good progress on the Foramen Finder lead placement technology we acquired from Radian in April, and we continue to expect it to be commercially available in mid-2024. Another project we're working on internally is a new external trial system that aims to enhance the PNE trial experience, making it more comfortable for patients and more convenient for physicians. Now, in closing, we feel like... Closing from my perspective, we feel like we're just scratching the surface of really what is possible in this under-penetrated and undertreated patient population. With that said, I'm gonna turn the call over to Dan, who has some prepared remarks with respect to the financial results. Thanks, Ray. As Ray noted, Axonics generated net revenue of $92.9 million in the Q2 of 2023. This represented an increase of 35% compared to the prior year period. Sacral neuromodulation revenue was $74.2 million, of which 97% was generated in the United States. Bulkamid revenue was $18.7 million, of which 79% was generated in the United States. Gross profit in the Q2 was $70.2 million, representing a gross margin of 75.6%, compared to 72.8% in the prior year period. In the first half of 2023, gross margin was 75%. While we are pleased with this result, as you know, gross margin is sensitive to overhead absorption, manufacturing yields, and supply chain disruptions. Taking these factors into account, given that we are continuing to ramp up the manufacturing lines of the R20 and S15 products, we expect gross margin for 2023 to be within the 73%-74% range for the remainder of the year. As we've stated previously, we expect gross margin at scale to be in the mid-70s. Operating expenses were $82.3 million in the Q2. Note that this includes a one-time $15.4 million non-cash charge for acquired in-process research and development related to the Radian technology acquisition of the Foramen Finder, and a $600,000 non-cash charge for the change in fair value of contingent consideration related to the Bulkamid acquisition. Excluding these non-cash charges, adjusted operating expenses were $66.2 million in the Q2 of 2023. We continue to expect adjusted operating expenses of $280 million in fiscal year 2023. Net loss in the Q2 was $7.3 million, compared to a net loss in the prior year period of $21.4 million. In the Q2 of 2023, Axonics generated $18.4 million of adjusted EBITDA, compared to $1.6 million in the prior year period. ... The attractive financial profile of the company and the inherent operating leverage of our business model is becoming more evident in our financial results. In fact, this marks the Q1 that Axonics was profitable on an operating income basis, which includes stock-based compensation, depreciation and amortization expense, and only excludes non-cash charges associated with the Radian in-process R&D and the change in the fair value of the contingent consideration related to the Bulkamid acquisition. Cash, cash equivalents, and short-term investments total $331.5 million as of June 30th. During the Q2, Axonics made a $35 million milestone payment to Contoura Holdings Limited, related to Bulkamid, achieving over $50 million of sales in the 12-month period ended March 31, 2023. Turning to fiscal 2023 guidance, our updated outlook is as follows: total company revenue of $358 million, an increase of $10 million compared to prior guidance. This represents an overall revenue increase of 31% compared to fiscal year 2022. We now anticipate S&M revenue of $285.5 million, an increase of 29% compared to fiscal year 2022, and Bulkamid revenue of $72.5 million, an increase of 40% compared to fiscal year 2022. This concludes our prepared remarks, and I will now turn the call back over to Neil. Thanks, Dan. At this time, we are ready to begin the Q&A session. We would like each analyst to have an opportunity to ask a question, we request that you please limit yourself to one question only. If you have an additional question, please reenter the queue, we will take your second question if time permits. With that, Victor, please begin the Q&A session. As a reminder, to ask a question, please press star one, one on your telephone and wait for a name to be announced. To withdraw your question, just press star one one again. Please stand by while we compile the Q&A roster. One moment for our first question. Our first question will come from line of Chris Pasquale from Nephron Research. Your line is open. Thanks. Congrats on a great quarter, guys. Ray, I, I thought the comments around the DTC campaign were, were interesting. Seems like the focus there is shifting a little bit, maybe getting a little bit more specific on the stress and, and fecal indications. I, I know one of the advantages you guys had there was the ability to be somewhat generic in the way you advertise because you covered the full spectrum. Just curious, how you're thinking about sort of optimizing that program longer term, and if you could quantify in any way what kind of return you've gotten thus far off of the work you've done there? Sure. Thanks, Chris. Appreciate your comments and question. Our commercials now, whether they be found on Facebook or on television, they are generic in the sense that we're just talking about if you have these symptoms, you're leaking urine, as an example, then we'd like to help you get a consult with a specialized or, or, you know, with a, with a physician in your area. We're not, we're not selling anything in 30-second TV commercials. We're not talking about sacral neuromodulation, we're not talking about Bulkamid. We're not being too specific at all about the condition. It's basically, you know, urinary incontinence has been the focus. The commercial has been pretty much geared towards, you know, overactive bladder patients. The responses, as you've seen, have been really amazing. In the first six months of this year, 1 million people, unique visitors, went to findrealrelief.com, and about 8% of them, you know, filled out a questionnaire and told us who they are and indicated an interest in getting with a physician. Of course, the challenge, of course, is getting those interested people actually, you know, booked with an appointment, and I'm sure everybody can appreciate that's not a simple process. Okay, having said that, we now, 18 months later, are able to measure a return on investment on a name-to-name basis. We can easily match the person who responded on the questionnaire to actually a patient who has an implant in their body. This is very encouraging for us. It is exactly what we had hoped, but we knew it was gonna take some time before we could actually measure a return. Given that we're encouraged by this, we wanna now increase, if you may, the messages that we're providing, you know, let's just say, on television or on the internet. This doesn't imply an increase in expenditure per se, but we're gonna have some different messages out there. One of the things that we're gonna do, and I'll try not to be too wordy about all this, is that we're gonna be running an ad on television, on Facebook, where we have a patient who is younger, a woman in her thirties, who had some children and has stress urinary incontinence. She's gonna say: You know, when I laugh, when I lift, when I exercise or cough or sneeze, I leak. Then I found Axonics, and I got Bulkamid. It's gonna be a Bulkamid commercial, all right? Which we haven't done before. Even though we're getting a lot of patients getting Bulkamid as a result of our OAB commercial. We're gonna be a little more specific, and then, of course, you know, their questionnaires will identify the symptoms that they have and so on and so forth. We're excited about that. We think that makes a lot of sense for us to do that. We're also gonna do a commercial for fecal incontinence. We have a patient. By the way, these are all volunteers. These are not paid actors or actresses. These are, these are patients who volunteered to, to do these commercials. We think that's a more powerful approach than having a celebrity or so on and so forth. In any event, so we've got a gentleman who's got fecal incontinence and, and, and we'll be very specific about his condition and, and the fact that Axonics therapy can help resolve this. That's what we're talking about when we say, you know, SUI and FI, and so on and so forth. We're gonna run OAB commercials, SUI commercials, and fecal incontinence commercials, and they'll all be running, you know, kind of simultaneously. Once again, we're not, we're not talking about tripling our spend or even doubling our spend. You know, we may spend a few more dollars incrementally, but we're getting a nice return. Hopefully, Chris, that's a super fulsome answer to, to your question. Yeah, that's great. Thank you, Ray. Dan, 1 for you. You know, the operating leverage has been very impressive, especially when you exclude some of the one-time items here. It certainly doesn't seem like mid-70s needs to be a final resting place for gross margin, given the progress you've already made. Why can't you push it further than that, particularly as the portfolio over time shifts, you know, I think, entirely to F15 and R20 versus carrying 3 products? We agree with you, and we can. We're just not providing guidance for 2024 yet. You know, we've picked mid-70s as the target going back a couple of years now. The messaging, we just wanna keep it on point, that we're clearly trending in that direction, especially when you see 75.6% in the quarter. We're just trying to, you know, keep everything in check as we ramp production. You're correct. Look, we don't have to change the product. We don't have to change anything in the supply chain. We just have to keep executing and have longer production runs, and we see it trending the way you do. Great. Thank you. One moment for our next question. Our next question will come from line of Larry Biegelsen from Wells Fargo. Your line is open. Hi, this is Nathan Treybeck on for Larry, how are you? In, in the past, you talked about your S&M sales growing at 25% and the market itself growing at 15%. How do you still feel about these targets, considering, you know, the strong growth you posted in the first half? Has anything changed with regard to market growth, and if so, why? Thanks. Well, look, I think that the, you know, the market growth is gonna continue. You know, unfortunately, only Axonics is involved in the market growth game. Our other competitor seems not to be too, too keen, let's just say, on doing some of the things that we're doing. Having said that, we're the ones carrying the water. We see that the, the market is growing, and, you know, in any given quarter, it's gonna be up or down or whatever, but 10%-15% is certainly in the range, and we think over time, 15% is what we would expect to see, which is consistent with what we've been saying since 2018. The market's been growing. You know, we're just focused on, you know, putting our heads down and executing the plan, and we've got a lot of initiatives that are happening in accounts to help identify additional patients that could benefit from the therapy. The issue is, and I've said this many times before, every single urology and urogynecology practice in the United States has anywhere from hundreds to thousands of untreated patients in their paper filing cabinets or their electronic EMR system. It's just simply a matter of activating those individuals and having somebody speak to them about the notion of an advanced therapy like we have, that provides a fundamentally permanent or long-term solution, and measured in 2 decades, to these chronic problems. We don't believe that Botox, which is a four to six-month treatment for OAB, is appropriate. Most patients drop out after two injections. We know that adherence to OAB medications is terrible, and that 70% or 80% of the patients will stop their medication, certainly within a year. These are, these are all the reasons why we believe that in the end of the day, sacral neuromodulation is the way to go. It's gonna provide long-term therapy relief for patients who have a chronic problem. The difference here is, despite the fact that there was a product in the marketplace for two decades, okay, with a company that had a monopoly, we're overcoming that, the notion that sacral neuromodulation is the therapy of last resort. That attitude is now changing amongst our physician customers and so on and so forth. We're extremely bullish about the future, and we expect to continue to grow our revenue in Sacral Neuromodulation for many years into the future. I have to tell you, Bulkamid certainly is helping us as well, because we're able to, you know, get more mind share from these customers by providing additional therapies. One last comment about that, and that is that, look, these are not discrete persons who show up. It's not like a woman shows up today, and she's got urinary urge incontinence. Nobody has fecal incontinence or nobody has a stress urinary incontinence. The reality is, a third of our urinary urge incontinence patients have fecal incontinence, and almost a third of those patients who have urinary urge incontinence have stress urinary incontinence. You know, that's the reason why Bulkamid is such an important part of our product line, because we're able to treat the whole person. That's, that's the, that's the, that's what we're up to. Thank you. One moment for our next question. Our next question comes from the line of Michael Polark from Wolfe Research. Your line is open. Good afternoon. Thank you for taking the questions. I think we know the why behind it, the Axonics value proposition, the innovation you've introduced into the market. But I'm curious, Ray, for your perspective on recent account conversions. You know, order of magnitude, have the numbers gotten bigger again? Maybe the other way to ask the question is, as I look at, you know, say, 30-35% SNM growth in the U.S., you know, how much, how much of that do you perceive to be from accounts that are freshly new to Axonics? Well, you know, Mike, thanks for the question. As we've said, you know, and I think everybody's acknowledged, and certainly yourself and other analysts have, have been writing about it, you know, the reality is that, you know, 60% of, of all the peoples, you know, practicing Sacral Neuromodulation in the United States, I mean, I'm giving you a round number, are, are not our customers today, okay? Now, I, I dare say that, you know, we're helping some of those accounts that are not our customers because people are walking in their office, too, asking about Axonics therapy, and they go, "Oh, yeah, well, we got that, too, but it's called something else." That's kind of what's, what's going on out there. For the first time, we're, we're creating awareness in the marketplace. It's this awareness that's being created and the tools that we're providing. In other words, something as simple as a symptom questionnaire that is handed to new patients when they walk into the door, or existing patients when they walk in the door, so that the patient can sit there and in two minutes can score themselves. If they're moderate to severe in terms of incontinence, then the physician and the staff can talk to them about, about this. This has never been done before. I mean, this is basic block, blocking and tackling. I mean, we're talking the most basics. Now, have we been able to get every account that we have to implement this? No. Okay, you know, we're still working through those processes, but what we're seeing is better utilization in these accounts than we've seen before. We've called it same-store sales. I think that's a good way to refer to it. They're increasing, and that is really what is driving the revenue of the company. Are we picking up new accounts? Absolutely. We're gonna continue to pick up new accounts, and I would dare tell you that until we have them all, we're gonna continue to hammer on everybody to get our message across. The word's out, right? The word is out. The docs are popping their head up out of the sand and they're hearing from their other colleagues: "Hey, these Axonics folks, man, they got the technology, they got great people, they provide great support, and these products last a really, really long time." I think we're doing all the right stuff, and it's just gonna be a matter of time now before we continue to have more and more share of wallet and more and more share of this market. You know, one of the things that we're keenly focused on in these accounts that we've converted is to get them to give us more of that business, right? We still have people that are splitting their business, and they may be early in the conversion to Axonics, so we still have a long way to go, even in the accounts that have recently converted. You know, I understand the question, and I understand that, you know, there's a lot of folks out there that are thinking, "Oh, wow, is this just a share shift game?" It's not. I mean, the fact is, it's not like these are budgets. It's not like sacral neuromodulation is budgeted, right? There's so many patients that are gonna get it. I mean, this is about patients walking in, coming to the realization between their physician and themselves, that this is the right therapy for them, and we're gonna continue to stay focused on that. Thank you. One moment for our next question. Our next question comes from the line of Shagun Singh from RBC Capital Markets. Your line is open. Thank you for taking the question. Ray, this one from me. Could you discuss where utilization could go for SNM procedures longer term? Perhaps you can share the current range within your customer base, you know, what that looks like, and what you're doing to really expand that. You did touch on DTC, but just curious if there's anything else we should be focused on. Thank you. I understand the question. I appreciate the question. I think that everyone would be surprised at how low the utilization of SNM is and on a per account basis. I mean, the average, let's just say the average, is in the neighborhood of, you know, 12-15 per year. I mean, this is abysmal in terms of what, what is, what is reasonable, what is possible, et cetera, et cetera. We're dealing with, you know, a whole lot of dabblers, as we refer to them, out there. That's the state of the state. That's, that's what we've, you know, kind of, you know, come into this market, and that's what we find. Now, are we satisfied with that? No, it's ridiculous. It's ridiculously low. Now, there are plenty of accounts that we have that, you know, they do, you know, 15 to 50 a year, and those are, those are some really, really nice accounts. There's less that do more than, say, 50 implants in a year. All right, nice prize, you know, if you can get those accounts, obviously, and we're, we're keenly focused on the smaller and larger accounts. All right, what are we doing? I mean, there's too many things that we're up to for me to describe on a conference call like we have today. I'll give you one of the most basic things that we do, which is the single most effective marketing program, and that is getting the account, with our help, to send a letter to their customers that have already been differentially diagnosed with, let's just say, overactive bladder or fecal incontinence, or whatever the case might be. Simple letter goes out from the doctor, personalized, you know, electronically signed by them. Included in the letter, it says, basically, "Hey, Dan, we've got new technology for your, you know, for your chronic condition. Why don't you fill out this symptom questionnaire and put it in this pre-stamped return envelope and send it back to our office?" Okay? Simple as that. It's all HIPAA-compliant stuff, and it gets great response from the existing patient base. This is back to my comment about in, you know, names in their file cabinets or, or, you know, or in their EMR system. That is, that is the number 1 thing, and it, and it really surprises our customers because they're like, "Oh, I thought I was doing a really good job." They realize they sent 500 letters out, and next thing you know, there's 30 or 40 people that have raised their hand and said, "Yeah, yeah, yeah, yeah, I wanna come in, and I wanna talk about this advanced therapy." That, that's 1 example. We also spend a lot of time with the APPs, these advanced practice providers, the nursing staff, the NPs, PAs, RNs in the account, so that we can help them with their talk tracks. How do you communicate about Sacral Neuromodulation or Bulkamid to your, to your patients? Enrolling them in this process because physicians have very little time, and I'm sure everybody on the call understands this. The average doc spends maybe 10 minutes with a patient. You can't rely on the physician to be explaining all these things to these patients. They're very limited on time. We realize this, and we've been working on all kinds of different programs where we can, we can help utilize the staff and so on and so forth, to, to get more patients in, into the, into the therapy. This is just one of a, a whole list of, of various different marketing programs that we have available. I mean, basic stuff, even things like making sure that on the physician's website, that they actually have information about Sacral Neuromodulation or Bulkamid. You'd be surprised, you know, a very small percentage of them even have invested in these types of basic things. It's not... And this is the point I've been trying to get across for a number of years now, that in order to grow this business, for us to continue to see increases in utilization and for us to grow year-over-year, it is not rocket science. This is all basic stuff, you know, 101 marketing, right, that we're talking about and so forth. Now, the fact that none of this has ever been done before, okay, this is not what was happening before, before Axonics showed up on the scene, is the time that it's taking now, we have to overcome the legacy, situation. I appreciate the question. Hopefully, this was a, you know, a good enough answer, so you get a sense about the kinds of things that we're doing. Thank you. One moment for our next question. Our next question will come from the line of Richard Newitter from Truist Securities. Your line is open. Hi, thanks for taking the question. You know, congrats on the, on the operating performance, particularly the, the, the margin improvement in profitability here this quarter. I guess my question is really just about how you are, you know, balance pursuing revenue growth from here, and, you know, you're clearly at an inflection point of sorts on, on the profitability curve. I'd love to hear, Ray, just, you know, how you're prioritizing those two, especially as we, we think, think out a little further, and, and particularly, if you could put into context where the investment goes with respect to reps, maybe even M&A, in addition to DTC. Thanks. Yeah. Thank, thanks for the question, and, and thanks for acknowledging the superb adjusted EBITDA result in the quarter, which I think really, as Dan said, it, it really underscores the leverage that we have in, in this, in this business model. So here's the thing, and we'll make this comment. We are not holding back on spending money. Let us be clear about that, right? We are doing everything that we think makes sense to help us grow this business. We are not holding back on hiring salespeople. We're not holding back on training them. We're not holding back on HQ visits from physicians or APP events or DTC. We are not holding back. This is not about squeezing blood out of a rock to make it, make it look good from a financial standpoint. This is natural. This is just what's occurring and naturally occurring in our business. I mean, that's, that's the comment. If we see an opportunity where, if we have underserved, in other words, if we're not making a penetration in a given part of the United States, then we're gonna add the additional people that we need to get to those accounts that we're not getting to. I, I, I think that, I think that's important for us to get that message out. You know, yes, we're at an inflection point, but it's a good one because we've got leverage in the business, and money's dropping to the bottom line, and this is what we had predicted all along. Dan and I are not surprised, that this is actually what's occurring. Granted, you know, the margin, okay, a point here, a point there, one way or another, is gonna be variable. Other than that, I think we've turned a corner now, and this is gonna be a fast-growing, profitable company for years to come. Thank you. One moment for our next question. Our next question comes from the line of Adam Maeder from Piper Sandler. Your line is open. Hi, Ray. Hi, Dan. Congrats on a nice quarter, and thank you for taking the questions here. I'll, I'll keep it to one. Wanted to ask about the updated guidance for the full year. You increased the guide by $10 million. It looks like that increase is evenly split between Sacral and Bulkamid. For Q2, I think you beat by $6.5 million or so, so you're, you're raising by more than you beat. Can you just talk a little bit about kind of what's informing that decision? Then broad strokes, any more color that you can provide on the second half cadence in 2023, Q3 versus Q4? Thank you. Sure. Hi, Adam. Thanks. Always good to hear from you. Look, you know, the thing that's driving the change in the guidance is... You know, look, we obviously meet regularly with the entire field team, and, you know, they basically come back with what they see each of their accounts doing. We roll it up to the area director level, and then we have a discussion. You know, look, we're, we're just being transparent and changing the guidance as we see fit, to be as accurate as possible. Really, it's just basic blocking and tackling. We have 725 plus employees in the company, with over 400 in the field. You know, as you would expect, we have a, you know, a very capable and large infrastructure of people and sales management, including the chief commercial officer, the area directors, and, you know, the key account managers. You know, we have very detailed, granular insight into each of our accounts. One thing that Ray talked about earlier was, you know, the same-store sales. You know, we've seen high teens growth in same-store sales from year to year. You know, for us to adjust guidance is just an indication it's going well. What we predicted and guided at the beginning of the year was that we'd have a big step up from Q1 to Q2. Q3 would look a lot like Q2, and then there's the, the seasonality step up in Q4 when patients have met their deductibles. Really no change in the guidance other than business is going well, and we just wanna keep messaging that everything is tracking according to plan. Thank you. One moment for our next question. Our next question will come from the line of Mike Matson from Needham. Your line is open. Yeah, thanks. You know, just given the, the strong adjusted EBITDA in the quarter and kind of what, you know, this consensus is modeling or the guidance applies for the second half, I mean, your revenue should be even higher. I mean, is there any reason that your kind of adjusted EBITDA margins won't at least stay at this level or even potentially go higher over the rest of the year? No, you're reading it. Hi, Mike. Good to hear from you. No, you're reading it correctly, which is, you know, when we look forward at the OpEx, we're still confirming the guidance we provided earlier in the year in terms of total OpEx for 2023. You're right, as revenue steps up, even with a, you know, a 1 or 1.5 change in the gross margin percentage, you're absolutely right, which is, it should continue to trend as you are estimating, which is it should look very similar or even better as we go into Q3 and Q4. We're continuing to add to the sales team. We're continuing to add some expenses in G&A, you know, back-of-house operations to support the field team and to support the customers. Just to lay it on the line, there's no significant OpEx expenditure that's coming, you know, down the lane in the near future that we see that's gonna impact our, our path to profitability. Thank you. One moment for our next question. Our next question comes from the line of Anthony Petrone from Mizuho. Your line is open. Congrats on a, a great quarter here. 2 quick ones, you know, from our end. Just kinda high-level views on the CMS proposal for, for tibial in the ASC setting. Just early views there from Axonics. If that were to be finalized, you know, how do you think that influences the decision between, you know, tibial and sacral neuromodulation next year? The other one, I'll quickly put it in there, is, you know, Intuitive Surgical reported a couple of weeks ago, opened up the idea that GLP-1s could, you know, are seeing some impact in U.S. bariatric surgeries, and one of the behavioral recommendations for overactive bladder is weight loss. I think there's a higher incidence in 32 plus BMI. Any, any thoughts on, you know, could, could GLP-1s influence the overactive bladder space? Thanks again. All right, this is Ray. Thanks for the question. Look, it's this GLP-1 phenomenon. I mean, I don't think anybody really knows what the impact's gonna be over time and how long anybody's gonna stay on that Ozempic or Mounjaro, or whatever it might be. We'll see, you know, what that means. We have tens of millions of patients with moderate to severe overactive bladder. We've got. I think the latest number was, like, 22 million, specifically moderate to severe stress urinary incontinence patients. I mean, this is a huge underpenetrated and untapped market. We are. ... nonplussed, and I wish everybody out there, you know, who wants to lose a few pounds, good luck, you know, doing that, right? That's great. In terms of implantable tibial nerve stimulation, I think the most recent comments or results from CMS, I think just simply underscore what we've been saying all along. You know, let me just be clear: We're in the sacral neuromodulation business. We think sacral neuromodulation is the way to go. These are permanent, long-term implants to provide, you know, symptom relief, in the 90th percent, you know, symptom relief for patients. We are not in the ITNS business. We don't intend to be getting in the ITNS business, and we don't see ITNS having any impact on our business, any measurable impact on our business going forward. I appreciate the questions. One moment for our next question. Our next question will come from the line of Kallum Titchmarsh from Morgan Stanley. Your line is open. Hey, guys, appreciate you taking the question. Just on Radian, could you maybe share some initial takes from any engagement you've had here with docs about the tech? We spoke with one recently, he seemed pretty excited about the placement solution, but I'd assume your sample size is a bit bigger than ours. Then maybe if you could share some thoughts on any further enhancements you'd like to add to the SNM portfolio in the long term. Thanks a lot. What was the second part of the question? Any other enhancements to the SNM system. I think that I alluded to it in my prepared remarks, that we also have a new external trial system that is forthcoming, and we think this is gonna make it more comfortable for patients and more convenient for physicians. That's kind of included and kind of, sort of combined with the lead finding or the sacrum finding technology, 2 discrete things. Just so we're clear, we did quite a bit of diligence with respect to the Foramen Finder. We discuss it when, you know, physicians come to visit us, and we get a lot of very positive feedback from them. Just to be clear, this product is not in anybody's hands. Okay? You know, you know, we're in the process of hardening, the, you know, or finalizing the hardware design and hardening the software package and all that stuff. You know, we'll start to, later this year, we'll get the product, you know, under, let's just say, a non-significant risk, kind of study concept into the hands of a few customers so that we can do some usability testing and so forth. Look, people are enthusiastic about it, but just in fairness, I don't wanna oversell it because the fact is, we haven't put it in the hands, of physicians yet. People get the concept, and they think this could be helpful. Back, back to talking about that, I mean, the just the elimination of, of having to use live fluoro, I think, is, is a big thing, because, you know, just less exposure to fluoro is a good thing. If we can help people save a few minutes, you know, by doing an external trial and getting that lead placed in the right place, then, then it's a winner. The, the beautiful part about the product is it's not expensive. It, it's a, it's a little piece of hardware and some software. It's not like this is a, you know, something that is costly or, or, or is gonna increase, create a burden in, financially or, or anything else. We're excited about it. We think it makes sense. We're gonna keep our eyes open. Anything that we can do that could enhance the SNM portfolio, then we're certainly keen on, on doing it. At the moment, I think we've got, you know, two big projects that are forthcoming in 2024, and, you know, that's keeping us busy internally. Thank you. One moment for our next question. Our next question will come from the line of David Rescott from Baird. Your line is open. Oh, great, thanks. Thanks for taking the questions and congrats on the strong quarter. Ray, I appreciate the comments that you provided just around this, you know, 15% kind of market growth outlook. You touched some of on some of the kind of account share basis, you know, growth that that's been going on in the quarter and thus far, so far. You know, we do get a lot of questions just around the 12, maybe 18-month kind of growth implications for SNM. When I look at consensus today and our model, I think 2024 sits at maybe 20%+ or so, and, you know, that assumes probably some of those share gains and some of those market growth outlooks that that you've talked about. I'm really just wondering here, you know, if you could provide any, any color, at least maybe more around specifically that level of visibility that you do have, that again, gives you just this confidence in a, you know, longer-term rising adoption trend for, for SNM as a whole. Thank you. Sure. I, I think, I think, folks know that, you know, personally, as CEO of the company, I'm probably a little bit more involved than most CEOs are in terms of customer-facing activities and, and talking with our customers. A, I enjoy it. B, it's helpful to have these kinds of conversations where I'm not relying on, you know, information that got filtered through, you know, 5 different layers. I can tell you that every single doctor that I've spoken to, and I've probably spoken to at least 100 of them personally this year, every one of them says they're not doing anywhere near the volume in SNM that they could be doing. They all will admit it now... that, you know, yeah, we've been doing a lousy job and, you know, only a very small percentage. I mean, we're talking less than 5% of the patients who, you know, are in their practice, have actually gotten advanced therapies, and so forth. We see what how this is happening with Bulkamid. This is very interesting. Look at this phenomenon, right? Nobody used bulking. Bulking is, is trash, blah, blah, blah, blah, blah. It was all about slings, right? Well, look what's happened. I mean, just in this last quarter alone, 20,000 people got Bulkamid. 20,000 people got Bulkamid, you know, for a product that heretofore nobody was using, okay? That speaks to the power of what happens when people get behind a new therapy and realize the, these great results. We're overcoming a legacy that existed for over two decades, where Sacral Neuromodulation was perceived as a therapy of last resort because it wasn't MRI compatible, it didn't last long, and it was fussy, okay? It's gonna take some time, and we're, we're three and a half years into the game with a global pandemic in the middle of it, towards changing the way people view this technology. I can tell you every data point we look at, whether it's same-store sales, whether it's response to DTC, whether it's response to mailers that go from the office, or whether it's attendance at the, at the events that we, that we put on, the interest is high, their patients are plentiful. All we need to do is have people open their mouth and say, "Hey, we have some technology that's gonna last a long time, that could solve this problem once and forever for you." It's working with stress urinary incontinence. Nobody wants a sling. They. They want relief, and they're signing up for Bulkamid left and right. Same thing is starting now to happen. There are little shoots that are springing up all across the United States with respect to this. We can't be more bullish. I, I don't know how to explain it, or what words I can use to explain how enthusiastic we are and how bullish we are about the future for this technology. Thank you. One moment for our next question. Our next question comes from the line of Brett Fishbin from KeyBanc. Your line is open. All right. Hey, Ray and Dan, thanks so much for taking the question. I thought I'd throw one in on Bulkamid. I think you mentioned on the last conference call that you were planning to start to look at placing some more focus on calling on GYN practices as, you know, a potential channel for Bulkamid procedures. Just curious if you could touch on, you know, if you think the team has started to make some progress on that initiative in 2Q, and then overall, how you look at the process for eventually bringing more of these doctors on board as potential customers, you know, given the scope of that opportunity? Thank you. Yeah, thanks. That's a really good question. Appreciate that question. Couple comments. I've talked about two initiatives, two kind of new marketing initiatives, if you may. One is a focus on Botox injectors, people that, you know, dropped out of the sacral neuromodulation game or never got behind sacral neuromodulation for the reasons I've already described. That is our number one kind of focus in terms of a new marketing approach. We now have just started, literally in Q3 now, marketing to physicians that do a lot of Botox to try to get them to listen, you know, take a meeting with us and listen to why they should consider doing less Botox and more sacral neuromodulation. you know, as we said in the past, you know, I mean, we think about in 2022, our data suggests that nearly around 150,000 patients got Botox. you know, and when you combine the two companies in the space for SNM, it was only 52,000 implants. you know, we see Botox as the big competitor, quite frankly, for sacral neuromodulation. Now, that wasn't your question, but going to Bulkamid, right now, we're only selling to urologists and urogynecologists. you know, more urogynecologists are doing more Bulkamid than the urologists because we have a lot of urologists that are focused on male urology, right? they're into, you know, all the other stuff, okay? GYNs are a huge potential opportunity for us because they're the primary care physician for most women, and it makes no sense that these women are walking in the door for their standard, you know, care, and they're not being offered a solution for incontinence. We know that they're all walking in that door first. Before they ever show up at a urogynecologist office, they're at a GYN's office, right? We haven't gotten around yet to a marketing initiative geared specifically towards that patient population because we've had other, you know, kind of bigger fish to fry, so to speak, and the Bulkamid business is going so well. We are gonna do it. You know, I think maybe it's best I, I say that, you know, we'll, we'll get something going this year, but really, it's a 2024 initiative. I think that's the best way for us to frame it. But you can see a lot of opportunity out there, for, you know, revenue growth on, on the Bulkamid side as well. Thank you. I'm not showing any further questions in the queue. I'd like to turn the call back over to Raymond Cohen for any closing remarks. All right. Well, thank you. Thank you for everybody's questions. They're really good questions today. We appreciate the questions. It always gives us a chance to give a little more color on these calls. I just wanna say that, look, we're, we're very thankful for the trust that our physician customers and patients have put into us. We, we really appreciate the support from shareholders who have stuck with Axonics through thick and thin, so to speak. I wanna thank all my colleagues here in Irvine who are, you know, got their heads down every day trying to make things happen and, and building our products with care and quality. Obviously, for our sales team, in the field, not only in the United States, but also internationally and down in Australia, for their, their efforts and dedication, to helping us fulfill our mission of improving the lives of, of, more adults with, with incontinence. I thank everybody for joining the call today and your continued interest in Axonics, and we look forward to speaking with you again in the near future. This concludes today's conference call. Thank you for participating. You may now disconnect. Everyone, have a great day.
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