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spk10: Good day and thank you for standing by. Welcome to the Anonix Q2 2022 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 that session, you'll need to press star 1 1 on your phone. Please be advised that today's conference is being recorded. And I will now like to hand the conference over to your host today, Mr. Neal Beloker. Mr. Beloker, please go ahead.
spk07: Thank you. Good afternoon, and thank you for joining Axonics' second quarter 2022 results and update call. Presenting on today's call are Raymond Cohen, Chief Executive Officer, and Dan Duren, President and Chief Financial Officer. Before we begin, I'd 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 1995. 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 Axonix's 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 four statements, which speak only as of today's date, August 1st, 2022. Except as required by law, Exonix undertakes no obligation to update or revise any forward-looking statements to reflect new information, circumstances, or unanticipated events that may arise. I would now like to turn the call over to Ray.
spk06: Excellent. Thanks, Neil. I would like to welcome everyone joining this afternoon's call. We're very proud of our second quarter 2022 financial results. Exonix generated total revenue of $69 million in the second quarter of 2022, which represents growth of 50% year-over-year. This record revenue result reflects growing demand for our best-in-class incontinence solutions. More specifically, cyclonal modulation revenue was $55.8 million, an increase of 39% year-over-year. This record level of FNM revenue is primarily attributable to the broad U.S. commercial launch of our recharge-free system, dubbed the Exonix F15, which, by the way, has exceeded our own high expectations. Now that the pandemic is receding, we are seeing signs that procedural volume for cyclinomodulation is expanding. In addition, we are continuing to gain share from the incumbent as we continue to make progress on our path to sequential modulation market leadership. Turning to Bulk Med, revenue in the second quarter was $13.2 million, including $10.2 million that was generated in the United States. Results were driven by solid reorder rates from existing accounts and the onboarding of new accounts. We now expect approximately 50,000 women will have their stress urinary incontinence symptoms treated with BocaMed during calendar year 2022. And we're just scratching the surface of what is possible in the large and highly underserved and under-penetrated female stress urinary incontinence market. Based on this quarter's strong results and positive business momentum, we are raising our fiscal year 2022 total company revenue guidance to $253 million from prior revenue guidance of $238 million, which represents growth of 40% compared to 2021. I'll provide some additional color and business updates prior to the Q&A session. So for now, I'm going to turn the call over to Dan for his detailed review of second quarter financial results. Dan?
spk11: Thanks, Ray. As Ray noted, Axonix generated net revenue of $69 million in the second quarter of 2022. This represents an increase of 50% compared to the prior year period. Sacral neuromodulation net revenue was $55.8 million, 98% of which was generated in the United States. VolcomEd net revenue was $13.2 million, of which 10.2 million, or 77%, was generated in the United States. Gross profit for the second quarter of 2022 was $50.2 million, representing a gross margin of 72.8% compared to 62.6% in the prior year period. During the quarter, gross margin benefited from higher sales volume partially offset by decreased efficiencies and overhead absorption and manufacturing yield. Volcomed cells and a product mix weighted toward the recharge-free neurostimulator, called F15, also contributed to a favorable gross margin compared to the prior year period. We expect gross margin to average 69% in the second half of the year and and at scale, we continue to expect gross margin to be in the mid-70%. Regarding our supply chain, similar to other medical technology companies, we have experienced challenges in sourcing certain components for our sacral neuromodulation system. To date, we've been able to manage through this by sourcing parts from new vendors and paying higher prices when necessary. Just as we solve a particular supply chain issue, new ones crop up So this issue remains something we are monitoring closely and working to resolve on a daily basis. Total operating expenses for the second quarter of 2022 were $71.6 million. Included in operating expenses are $12.2 million of non-cash costs for the change in fair value of contingent consideration related to the acquisition of Bulk Med. Excluding non-cash acquisition-related costs, operating expenses were $59.4 million compared to $44.7 million in the prior year period. Net loss for the second quarter was $21.4 million compared to a net loss of $25.1 million in the prior year period. As of June 30, 2022, Cash equivalents and short-term investments were $213 million, which is unchanged from March 31, 2022. Turning to fiscal year 2022 guidance, our updated outlook is as follows. Total company revenue of $253 million, up $15 million from prior guidance. This represents an overall revenue increase of 40% compared to fiscal year 2021. We are now expecting S&M revenue of $205 million, an increase of 30% compared to fiscal year 2021, and Bulk Med revenue of $48 million, an increase of 111% compared to fiscal year 2021. I will now turn the call back over to Ray for additional remarks. Thank you, Dan.
spk06: I would now like to provide a few updates on our commercial and product development initiatives. In April, we commenced the broad U.S. commercial launch of the Exonix F15, our newly developed recharge-free sequenomodulation system. Physician response to the introduction of the F15 has been overwhelmingly positive. Exonix is now enjoying the benefits of having a complete sequenomodulation portfolio. And as a result, we are now capturing a higher share of wallet in existing accounts and selling our S&M products into what were previously competitive accounts. These accounts are more receptive to doing business with Exonix now that we have a non-rechargeable option to offer them. During the second quarter, the Exonix F15 represented approximately two-thirds of our cyclone modulation sales mix. As we have said previously, we are agnostic as to which Exonix Neurostimulator is implanted and are pleased to offer physicians and patients the choice of two safe, highly efficacious, and significantly long-lived cyclinomodulation devices. As a reminder, when we entered the U.S. market in late 2019, the only S&M product available from the incumbent lasted only three to five years, and required explanting if the patient needed an MRI. Today, we have two small devices that are full-body MRI compatible for both 1.5 and 3T scanners and expected to provide patient symptom relief for approximately 15 to 20 years, and in some cases, even longer. In April, we also launched our direct-to-consumer television advertising campaigns. The Find Real Relief campaign is directed towards women with any form of urinary incontinence. The campaign aims to reduce the stigma associated with these conditions, raise awareness of the Exonix brand and therapies, and with our assistance, help women consult a bladder specialist. The television advertisements are scheduled to run through the end of this year. The Find Real Relief campaign also includes targeted advertising on YouTube, Facebook, digital radio, and various websites. As a reminder, the advertisements encourage viewers to visit findrealrelief.com, our new patient-facing landing page. This website provides information about exonics and continent solutions and directs interested individuals to complete a short symptom quiz. In the second quarter, we had over 400,000 unique individuals visit our patient landing page to learn more about exonics therapy. Qualified individuals who fill out the survey are then contacted by a team of nurses in an effort to connect the person to a urology specialist in their community. In addition to the thousands of patients filling out the surveys and getting referred, many of our customers tell us that patients are coming into their practice asking about exonics therapy after seeing our commercials on television or ads on Facebook. Even though we are in the early stages of our DTC efforts, we are already able to measure reductions in cost per inquiry, cost per qualified lead, and patient procedures that can be traced back to our DTC efforts. As a reminder, we acquired Bulkamed or the Bulkamed hydrogel for female SUI on February 25th 2021. In just 16 months since we began marketing Bulkamed to physicians in the United States, Exonix has achieved market leadership in bulking for stress urinary incontinence. In the last three months alone, over 10,000 women in the United States and another approximately 3,000 women internationally have had their SUI symptoms resolved. In the U.S., we onboard new customers every day. However, it is the same store sales that are driving the revenue result. As mentioned earlier, we now expect approximately 50,000 women will be treated with BocaMed during calendar year 2022. This level of sales is two full years sooner than what we had previously anticipated. As expected, BocaMed has increased our stature with the urology community in the U.S. given that exonics is the only player that offers treatments for women with any form of incontinence. Bottom line, BulkMed is fast becoming first-line therapy for women with SUI and an extremely attractive alternative to a surgical sling operation. Turning to product development initiatives, in late May, we submitted a PMA supplement to the FDA for our fourth-generation rechargeable neurostimulator. Our current rechargeable system requires recharging only once a month for one hour. The fourth-generation device, which is the same small 5cc form factor, will need to be recharged just once every six months for one hour. We continue to expect this device to be approved before year-end 2022 and to begin shipping to customers in the first part of 2023. Finally, on the reimbursement front, CMS recently published proposed outpatient facility payment rates for 2023. The relevant sequential modulation codes proposed an increase of 5% to 7%, while a relevant bulk med code has proposed an increase of approximately 4%. So in closing, I'd like to say that we remain grateful for the trust of physicians, patients, and shareholders that they have placed in Exonix. We would also like to thank our commercial field team and our colleagues in Irvine for their diligent efforts and dedication to fulfilling our mission of improving the lives of adults suffering from incontinence. With hard work and a keen focus on quality products, great clinical outcomes, and strong support, Exonix is making significant progress on its path to S&M market leadership. So at this time, we're happy to take questions. I'm going to like to turn it to the operator.
spk10: Thank you. As a reminder, to ask a question, you'll need to press star one one on your phone.
spk09: Please stand by as we compile the Q&A roster. One moment.
spk10: Our first question will come from Travis Steed of Bank of America Securities. Your line is open.
spk04: Hey, good afternoon, and congrats on a good quarter. I guess I'd start with the F-15 mix this quarter, two-thirds of the F&M business. I don't know if there was a one-time uplift from the launch or how you're thinking about that mix moving forward. It seems like there's a big preference for the F-15 over the recharge device. I don't know if you see the market moving away from recharge. And also, if you could give a little color on the accounts this quarter and what portion of that was breaking into new accounts versus F-15 replacing some of your existing recharge businesses.
spk06: Sure. And thanks, Travis. I appreciate the comments and the question. So there was a multi-part question, so I'm looking at my colleagues that will help me sort this out. But look, the F-15, I mean, has taken off like a rocket ship. There's no question about that. I think that the reason is really primarily attributable to the fact that for over 20 years, physicians in the United States have only worked with a non-rechargeable system. I think the attractiveness of the F15 product, where with a good implant, physicians can get over 20 years in a patient's body, I think is something that no one has anticipated. So given that it's a recharge-free system, the patient remote does not need to be recharged and doesn't require replacement batteries, I think that the market has found this to be very attractive. So I think there obviously was some enthusiasm about people getting their hands on the new product and trying that out. I mean, it's 20% smaller. It's... you know, it's a good form factor and so on and so forth. So I would say that I would expect that the mix, if you may, and I think that was one of your questions, I think the mix will kind of swing back to probably 50-50 over time. I don't think it's that unusual that, you know, in the quarter that we introduced the product that, you know, it would have swung in the way that it did. So I think that's one part of the question or two parts of the question. So in terms of account acquisition, there are two things I mentioned in my remarks, Travis. One was that we're getting a higher share of wallet in the existing account. So I've said in the past, I've said this product is expected to close the hole in the bottom of the bucket where we were bleeding out even in loyal existing accounts that were happy to do business with Exonix, we were still bleeding out some revenue out the back door based on not having a non-rechargeable option. That has stopped. And we have, of course, as represented by the increase, the significant increase in the revenue from Q1 to Q2 and year over year, it's clear that a lot of new accounts have come our way. or I should say competitive accounts that may not have been working with us before, or if they were, they were doing some rechargeable and, you know, we weren't getting the lion's share of the wallet in those accounts. So, I mean, as you can see from the result, I mean, things are going quite well for the company, and the fact that we, you know, we have the complete line now, and I would dare say, you know, longer-lived products, higher-quality products, easier-to-use products that it's really been turning a lot of heads from the physicians that might have been reluctant in the past to come our way. You know, BocaMed was the first foray, right, where we got a lot of people wanting to get behind BocaMed. That gave us a chance to be in those accounts. And then, you know, next thing you know, we come out with a recharge-free system, which has really surprised people in terms of its characteristics. And the good news is we were already in the accounts. We were there with Exxonix personnel. So, you know, what we had hoped in terms of the lift in Thatcher, the lift in a good listening from customers with Volcomed has paid off. And obviously it's now a one-two punch between Volcomed and F-15.
spk04: That's a helpful color. Just a quick follow-up on the guidance. It looks like US S&M guidance assumes pretty much flat Q3, Q4 revenue versus what you did in Q2. just to see conservatism at this point, but would love to hear comments on the guidance there, and then if there was any stocking this quarter.
spk06: So, you know, with respect to stocking, this is something we've talked about since we first started. We're not in that business, so to speak, right? We only sell products that are earmarked to be implanted in patients. So, you know, there may be a par level that, you know, accounts that are doing a reasonable number of implants. They might keep one or two on the shelf. But other than that, it's just not something that we have done. We don't incentivize our salespeople. So, you know, what you see is what you get with Exonix when it comes to sales revenue. In terms of going forward, look, I think that we're trying to be conservative in particular about this current quarter. not to suggest that July sales were a problem. July sales were very good, but there's a lot of vacations going on right now, and I think anybody recognizes that this is an issue. Q3 is always lighter in the medical device market, and this year I think everybody and their brother and their cousin is going on holiday somewhere. And I think physicians and patients, obviously, you know, are in that boat. So we're comfortable with consensus, which is a little over $51 million for S&M in Q3. And, you know, we've obviously increased in guidance for bulk med by a couple million dollars. So we think, you know, 11.8 is a reasonable number. that we could achieve. There's going to be some drop-off clearly in Q3 as compared to Q2, and then we think, you know, we'll go strong into Q4. So that's kind of how we see the rest of the year playing out, and I appreciate that question, Travis, because hopefully that'll help, you know, with the rest of the questions that we're going to get in a moment. Right.
spk04: No, thanks, Ray. Very helpful. We'll follow up.
spk10: Thank you. One moment for our next question. And our next question will come from Adam Nader of Piper Sandler. Your line is open.
spk02: Hi, Ray. Hi, Dan. Congrats on a great quarter, and thanks for taking the questions here. Maybe just to start, would love to ask for a little bit more color just on what you're seeing from a you know, procedure environment standpoint, and maybe just to kind of run through some of the puts and takes, you know, on the headwind side, anything from a, you know, staffing standpoint that was noticeable or, you know, procedure cancellations from COVID-19. Did you have any catch up on the tailwind side of things? Obviously F-15 had a nice impact this quarter, but maybe just walk through some of those puts and takes. And then to the extent you're able to kind of provide some color on monthly progression in Q2. That would be much appreciated. Thanks.
spk06: So the last question was about progression during the quarter, April, May, June. And it was strong throughout the quarter. It's not like, well, June was double what it was in April. So it was a good, strong quarter and pretty solid progress. month to month. So nothing really worth talking about there. I do understand that maybe a company or two that has come before us in terms of their results were pointing towards the notion of COVID being a problem, deferrable procedures, staffing shortages, things from that standpoint. You know, Adam, I mean, all I can tell you is we just weren't impacted by those factors. We just weren't. You know, COVID is still real, and I think, you know, we do see there's a little bit more infection that's going around in real time than there has been, let's say, in the previous three months. What I had said and have said many times is that if you give exonics a clean quarter of where we're not impacted directly by COVID and deferment of procedures and cancellations and all that, we'll show you what we can do. And I think this is the first quarter really since early days of 2020 where we've had a pretty clean quarter. So from our perspective, we really just didn't see any kind of procedural slowdown or issues with staffing that got in the way of us being able to get our business done. I just want to remind people that, you know, we have 100% outpatient procedure here. I mean, this is a day case. Patients are in the institution for a few hours, whether it's an ASC or an outpatient section of the hospital. So, you know, when it comes to staffing shortages, I can see where companies that have procedures that require multiple days, you know, in CCU, ICU, things of that nature, that's not the case for us. Did we see a catch-up of implants? Well, not really. I mean, we've been consistent all along that, first of all, we don't track cancellations per se. It's just not... The juice isn't worth the squeeze for us in that regard. So I understand the question. I understand the reason for the question. But Q2 for Exonix was a beautiful quarter, and things just kind of broke our way that entire quarter. Now, in Q3... Sure, we'll see a little bit of seasonality in this quarter, and we'll just keep our fingers crossed that the COVID headwinds, you know, stay, how should we say, minimal at this point.
spk02: That's great, Color Ray. Appreciate that. And then for the follow-up, maybe just to ask about VolcomEd, can you level set us on where you are in terms of number of accounts? Where can that figure go in the quarter, I'm sorry, in the future? You know, is the growth being driven by same-store sales, or is it new physician ads? And then maybe longer term, do you think this is a technology that can potentially go beyond the urologist and urogynecologist, you know, call point and potentially into the gynecologist community? Thanks so much for taking the questions, and congrats again.
spk06: Yeah, thanks, Adam. Appreciate your comments. Look, I think that every GYN in America should be doing bulk meds. It has not been a focus of a call point for us, but it will be one in the future. There's no question. And, you know, bulk med is fast becoming first-line therapy for patients with SUI because women would much rather choose to get, you know, an injection and be done in 15 minutes and dry and, you know, get off the table dry and walk out the door and go about their normal activities, right? There's no downtime. There's no recovery. The product works really well. It's as non-invasive as you could imagine. So this product has got legs. And I think that we could be accused of sandbagging, but the facts are that we never expected it to be as big as it is and to be embraced to the level that it's currently going. I'm going to avoid your question about the number of accounts because we would prefer not to give that information out. I would tell you it's a substantial number. But it is same-store sales, as I mentioned in my remarks, that are driving the revenue. So this is not about just adding people and them doing a couple of procedures and then on to the next and the next. That's not the case. This is people realizing how well this works and then starting to incorporate this as a big part of their practice. Where can this go? You know, I've made some comments at a conference or two that I thought we've got $100 million product line on our hands. And I honestly believe that, and now the data and the numbers are supporting that. So with the exception of a little seasonality, which we're going to probably expect to have right now in real time, I think that, you know, this business should continue to grow, and BocaMed should continue to grow for us very nicely. I mean, whether we can keep up 111% year over year is another story altogether, but it's really going great. And the feedback from the marketplace has been spectacular. And the magnitude of the number of women that we are treating, I mean, it's over 13,000 women treated with this product worldwide, vast majority in the United States. It's just incredible to see, and it's very rewarding for us, as you might imagine. I mean, we're just thrilled to death that we're able to help so many people who are suffering with this very annoying problem and to get those women dry. Now, the last part of your question was, did he ask other clinical indications or just other markets? Okay, cool. So we'll leave it at that, Adam, and I appreciate your questions and your comments.
spk02: Thanks so much, Ray.
spk10: Thanks. Thank you. One moment for our next question. Our next question shall come from Cecilia Furlong of Morgan Stanley. Your line is open.
spk01: Great. Good afternoon. Thank you for taking the questions and congrats on a great quarter. I wanted to start just with your gross margin outlook for the back half of the year. Really versus what you saw in 2Q. And if you could just walk through how much of that is stemming from conservatism or just supply chain potential headwinds that you're thinking about offsetting really the positive impact you could see from F-15 and bulk amid.
spk11: That's primarily, hi Cecilia, that's primarily conservatism. I mean, our gross margins are tracking according to plan. We've always said at scale we expect to be in the mid-70s. Things are going quite well. But we're launching, you know, we just launched a new product, and we're still ramping up manufacturing for that. We brought a number of process steps in-house, which contribute to higher margin. But, you know, with that, and I made the comment partially offset by decreased efficiencies and absorption and yield. That's where that comment comes from. So we just don't want to oversell it. And it's really not so much about supply chain risk as it is just ramping up the manufacturing of this product and also ramping up the manufacturing and getting prepared for the eventual market launch of the next generation rechargeable system, which will be the one with the recharge interval once every six months, one hour once every six months. So we're just being conservative. We don't want to get over our skis and promise you know, low 70s this year and then disappoint. So we raised it up slightly from where we were before. And that's why we're saying 69% for the back half of this year.
spk01: Okay, understood. And if I could follow up as well, just how you're thinking about OpEx for the back half of this year and really incorporated in that where you are right now relative to your DTC expectations for the year and how we should think about the cadence 3Q to 4Q around DTC, both from an expense standpoint, but then how you're thinking about it from an adoption or kind of seeing it translate into increased volumes. And thank you for taking the questions.
spk11: Now, go ahead.
spk06: Yeah, sure. So, Cecilia, I'll start and I'll pass it to Dan. So, look, we're full-blown into the DTC effort. So, the expenses that we incurred in Q2 are consistent with what we would see in Q3 or Q4. So we've accounted for that. The DTC effort has gone quite well. I mean, so many people are responding and the ads are resonating. However, what we have learned is that about 60% of the people who are responding are naive patients, meaning these are patients that haven't even tried a drug yet. Now, some of them could, you know, have SUI and that are responding as well, right? But the patients who have urinary urge incontinence, we're finding that they're early in the care pathway. Now, the 40% that are later in the care pathway that have tried a drug or may have had Botox in the past or might have even had an interstim years ago that's dead in their body or something like that, those are the patients that we're going to see faster conversion into procedures. I would say that we're still looking at, you know, four to six months is like the timeline, the gestation timeline, if you may, for somebody to, you know, see an ad, go to the website, register themselves before we, you know, could start to see some procedures. So we have a lot of anecdotal information here and there, but we have the ability to track this, and we are going to track it very closely. So right now it's the stats that we can share are – only relevant to cost per inquiry and things of that nature, which obviously is much easier to track in the early days of the DTC effort. But it's not like some big surprise coming in terms of DTC expenses in Q3 or Q4. So with that, I'll pass it to Dan for the rest of the answer.
spk11: Yes, thanks, Ryan. We mentioned operating expenses for the corridor were $71.6 million. But of that, $12.2 million was related to a non-cash accounting entry related to contingent value consideration. So when you back that out, OPEX, even with stock-based comp and depreciation and amortization, was $59.4 million for the quarter, compared to $64.8 was the consensus estimate. So we're $5.4 million under or favorable for the quarter. And so what we're sticking with now is we don't think we want to move the consensus estimate for Q3, which is currently at $66.6 million, or for Q4 of $70.7 million. We're happy with how expenses are going. We're being disciplined. And as Ray said, we don't foresee any surprises in the back half of the year on OPEX.
spk01: Great. Thank you for taking the questions, and congrats on the quarter.
spk08: Appreciate it, Cecilia. Thank you.
spk10: And one moment for our next question.
spk01: And congrats on the quarter.
spk08: Appreciate it, Cecilia.
spk10: Thank you.
spk09: And one moment for our next question. Our next question will come from Lawrence Eagleson of
spk12: Good afternoon, guys, and congratulations on a really impressive quarter here. Ray, a couple follow-ups from me. Maybe if you could talk a little bit more about the supply chain challenges. And, you know, I think in the past when we've talked about this, you've talked about having at least for F-15 significant amount of inventory. So where are you on inventory and how big a concern are these supply chain challenges that you mentioned? I had one follow-up.
spk06: Sure, sure. So thank you for your comments, Larry, and I just want to let you know we changed the conference call to Monday so that you could join.
spk12: Thank you. Thanks for doing it on a night when everyone else isn't doing it. Seriously.
spk06: Exactly. We tried to find a night where it was empty or open, you know. So in any event, sorry, I couldn't resist, Larry. It's been quite a few times when we've bumped up against everybody else. So In any event, look, supply chain issues are real. I mean, everybody's talking about it. It exists in every aspect of our lives right now. And, you know, we're seeing it. And as Dan mentioned earlier, you know, it's like you get one, you solve one issue and then, you know, here another one. It's like whack-a-mole, you know. And it's just an issue. Prices are increasing. You know, everybody's got a price increase, everything from components to plastic to you name it, you name it. And it's just something we're all working through, and I think the whole industry is just scrambling around trying to make all this work. One day it's epoxy, the next day it's some component you need to put on a board. Having said that, we've got a strong balance sheet, right? So we've always tried to use our balance sheet to keep ourselves out of trouble. We've got product ordered from every key supplier from now until the cows can come home for two years out even. and we continue to be vigilant and do everything we can to stay on top of our suppliers. We don't mind the price increases as long as we get the product, right? So, you know, that's what's going on. Now, F-15 is a new product, so obviously we haven't had time to stack up inventory the way we did on the rechargeable, right? So it is a little bit hand-to-mouth in that regard, but our team is working vigilantly to stack up products. So at the moment, you know, we're on it. We're paying close attention. And, you know, there's no cause for alarm. Having said that, this is the business we've all chosen. And, you know, we got to execute not only on the revenue side, but we have to execute on the manufacturing side as well and just kind of work through some of these challenges. So hopefully that answers your question with some reasonable level of color.
spk12: Yeah, it does. Thanks so much. And just one follow-up. I'd love to understand how much you think you're expanding the market versus taking share, green failed accounts, if you will, versus competitive accounts. And on competition, what kind of response have you seen? Thanks for taking the questions.
spk06: Yeah. Thanks, Larry. You know, it's been, as we've said all along, it's been challenging to try to measure increases in the size of the market given the COVID-related issues. So, you know, I would like to kind of let a couple more quarters go by before we could come back and say, yeah, we see that. We are seeing our existing customers expanding their, you know, expanding the number of procedures that they're doing in cyclinal modulation. I mean, we track that very closely, and we are seeing increases there. The question is, is that closing the hole in the bottom of the bucket, or is that actual procedural volume? We suspect, as we have said earlier, that the market will grow by about 15%, and we're going to grow faster than the market. So we are seeing that. It's just going to take a couple more quarters before we can be a little more definitive about that. I think that answered the question directly, so. Hopefully we can get from there. So, yeah, please.
spk12: Competitive response, Ray, anything?
spk06: Yeah, yeah, yeah. The competitive response is, I always got to be careful, right? You know, people listening. It's been puny. I mean, I think that's the only thing to say. I mean, you know, our competitor has tried every possible scheme and story and, you know, everything you can imagine to try to, you know, hold us back. But, you know, despite, you know, all the noise that they created in the past, you know, customers are paying attention to the quality of the products and the quality of the support and are coming our way. So I just don't see anything. I mean, you know, the interest in X came out, you know, with let's just call it, you know, an 8 to 10-year longevity in the body. And, you know, we're double that. So far, so good. You know, I don't know what other tricks they might have up their sleeve, but we're not thinking about it. We're not worried about it. We just got our heads down and taking care of our customers and fighting to pick up contracts in some remaining hospital systems that, you know, hadn't contracted with Exonix in the past. So there's still a lot more blue sky ahead for us, and we feel pretty bullish about our prospects going forward. All right. Thanks so much. Thanks Larry.
spk10: Thank you. One moment please for our next question. And our next question will come from Mike Pollock of Wolf Research. Your line is open.
spk13: Good afternoon. Thank you for taking the question. I have one more on MIX. Curious if anything is evolving on this front. prior period, say last year, year before, Interstim replacements as a portion of your business had bounced around from 10 to 15%, give or take. I'm curious with the chart, the launch of F15, have you seen that mix change dramatically, or is it still kind of 90-10 new patients, Interstim replacements?
spk06: That's a really good question, actually. It's about the same. I mean, we've had a fair amount of replacements all along, and I think that's just the consequence of being in these accounts and having people switch wholesale to Exxonix. So therefore, if they'd done S&M in the past, they got patients coming back who need a replacement, then we're getting it done. So I think you've got it correct. It runs between 10% and 15%. of implants that we're doing. And in terms of, you know, what is the longer-term impact of the recharge-free system on either the pace of replacements or how the mix is going to go, you know, in quarters to come, it's just a little early for us. You know, we've only had that product in the market for, well, now with July for call it four months. So it's early, but look, the product is working phenomenally well. The quality of these implants are, I think, better than we would have imagined. And I think part of that is because our people are very vigilant with these physicians in the OR. We want them to recognize and to understand that the quality of the implant has a direct impact on the longevity of the device. And this is something... That is new information to most of these implanters. You might think, oh, that's obvious. But it wasn't obvious in the past because the incumbent, as we refer to them, didn't really care. I mean, if you did not a great implant and the device only lasts for three or four years, well, they had no competition. They're happy to make another sale. We're asking our physicians to take a few extra moments to be careful about the placement of the lead because it has a direct impact on the longevity of the non-rechargeable device or the recharge-free device. So I think that, you know, if you may, it's the training, it's the attention to detail that is motivating these physicians, and they're amazed. I mean, when they walk out of the ER and done a nice job in an implant and we can share with them that we're expecting this device to last 22 years in the body, You can imagine there's not a lot of debate about whether Exonix is getting that next implant.
spk13: Good color, if I may. One follow-up on the DTC effort. And I may have misheard, so please just tell me if that's the case. But, Ray, in your prepared remark, you said something about the TV ads are scheduled to run through the end of this year, which caught my ear. And then in the context of your response to one of the prior questions, you know, 60% of the folks showing up at findrealrelief.com are treatment naive and need to start with drugs before, you know, they're candidates for you. And so I'm putting this together and, you know, maybe not hearing a commitment, you know, no hold far to this effort and 23 and beyond, so I guess what, you know, sitting here knowing you're going to have a bunch more information in six months, like what are the odds that this effort continues at the current pace in 23? You know, what are the chances that, you know, it kind of takes a new form? You know, any color on this investment in the out years would be helpful. Thank you so much.
spk06: Yeah, thanks. It's a good question, but I think it's, once again, it's premature, you know. for us to make a decision around what kind of spend we might have in 2023 on DTC. I mean, it's clear, as we do in every aspect of our business, we're going to optimize this process, right? We've already learned some things that have increased response rates and that are helping us move these patients fast, or they're not patients yet, move these people faster through the process to land them with accounts. So I'm not trying to be evasive. I just don't have the answer to your question yet, and we're saying we're committed to running it through this year, and then we will evaluate, and then we'll look to optimize, and then we'll then talk about what our level of expenditures might be Um, but, uh, it doesn't seem to, let me just say this. There's no fallout fall off in terms of response rates, right? As we continue to run these ads, the response rates are actually increasing. So I think this is that repetition, you know, uh, anytime you do this kind of advertising, you know, it does require a fair amount of repetition for people to actually take action. So, um, You know, that's where we are. So I don't, once again, I'm sorry to not give you a hard answer, but hopefully you guys will appreciate that we're looking at this closely and we'll make our best judgments going forward.
spk13: Fair reply, Ray. Thank you so much.
spk06: Thank you.
spk10: Thank you. One moment for the next question. And our next question shall come from David Rescott of Tourist Securities. Your line is open.
spk03: Hey, Ray and Dan. Thanks for taking the questions and congrats on the quarter. First one from us just on profitability. I know in the past you've kind of talked about this $350 million annualized run rate is where we could start to think about break even for the company. So I guess, you know, after the quarter, you know, where some pretty decent numbers are shown so far, I guess one is, Is this still the kind of goal for the company? And two, if so, I mean, looking at some of the updated guidance for this year, consensus growth estimates into next year, it would seem to suggest that, you know, breakeven could be possible as early as even the middle of next year. So I guess just based on what you're seeing in the underlying business, expected spend with DTC over the next 12 to 18 months, does this seem like a reasonable timeframe where we can start to think about some breakeven for the business?
spk06: Yes. Thanks, David. Appreciate the comments and your question. It's a good question. And I think for the first time since we've started this commercial effort as a company, we're seeing leverage. We're actually seeing leverage in the business based on this level of revenue. And we anticipate that will continue because it's not as if, and Dan has said this many times, it's not as if we need to add another 100 salespeople in order to grow our business again in 2023 over 2022. We feel like we're fully staffed at this point. Yeah, will we add some incremental heads here and there? Of course we will in sales. And more heads, of course, in manufacturing to keep up with demand. But we're starting to see leverage already, and we're not walking back off previous comments about this $350 million or so level of revenue. So we're sticking with that. With margins in the low to mid-70s, with some more revenue on the top line and with discipline in terms of expenses, I think we're going to get there. So that's pretty exciting. I mean, you know, as we sit here today, I mean, we only started this game in November of 2019, and it's only been a few years, and we've had a pandemic in the meantime. So, I mean, honestly, things could not be going better for Exonix, and we're just thrilled with the pace that the business is growing. And And really looking forward to closing out the year strong and an exciting 2023.
spk03: Okay, that's helpful. I guess on bulk, and I know in the past you've always talked about how the share gains here, you know, are coming from existing bulking procedures as well as essentially taking share from sling procedures as well. So my guess is that you've probably obviously had a lot of success with taking share from the bulking agents thus far and I'm just wondering if you could comment at all about where you're seeing the biggest growth from. I mean, are you seeing growth from sling procedures already, or is a lot of this really just coming from bulking, traditional bulking agents?
spk06: Thank you. Yeah, so, David, that's a really good question, actually. So here's the reality. Bulking has been, in the past, kind of a therapy of last resort. It was used as salvage almost. I don't think any of the physicians were particularly keen on any of the bulking agents that have come before us. So, you know, it was never seen, never used for the most part. I mean, everything I say, of course, you have to, you know, qualify a bit. But bulking wasn't done as a first-line therapy. And so this is a completely new phenomenon. And here's the reality. If you just think about this. A woman walks in the practice complaining that when they cough or sneeze or pick up an object or exercise or any one of the normal daily activities, they leak urine. And it's become bothersome to them, so they're seeking treatment. Here's your options. I can do Volcomed right here, right now, 15 minutes. You're off the table dry, no recovery time. Or... We can sign you up for a surgical procedure called Sling. I'm a great surgeon. You know, I know there's some adverse events associated with that, right? But, you know, in my hands, you know, we're going to do a good job. But you do need to be aware. We have to schedule it, and there's going to be recovery time associated with that. And, you know, but it's effective, and it works really well. Now, this Bulkamed stuff, you know, you could get seven years with this product, maybe even if it only lasts five. You just come back, and we'll give you a couple more injections, and you're good to go. Which would you prefer, ma'am? And the answer's in the back of the book. So these women are selecting Bulkamed as treatment for SUI. And every single patient that gets bulk med, that's one less sling operation that's being done in America and around the world. So hopefully that's a very definitive, straightforward answer to your question.
spk03: Yeah, thanks for asking the questions, and congrats again on the quarter.
spk06: All right. Thanks, David. Appreciate it.
spk10: Thank you. And one moment for our next question. Our next question will come from Mike Madsen of Needham and Company. Your line is open.
spk05: Yeah, thanks. So I wanted to follow up on Larry's question about Medtronic's response to your success and, you know, just ask about pricing specifically. I mean, they seem to be kind of against the ropes here. So, you know, what would happen if they did try to play the pricing card and really lower prices aggressively? Do you think that would even get any traction in the marketplace to the Would that benefit the doctors' wallets at all, or is it all really just going to the facilities?
spk06: Well, so, Mike, you know, prices, it's a fairly complicated process. So a couple comments I want to make. One, we have not had any price decreases in the last year over year. So year over year, actually, we've got, you know, slightly higher prices that we're getting for our products. But it's in the margin. Let me just make a comment. First of all, Medtronic has the lion's share of the business right now. So why would they drop their price? It's completely illogical. Second thing, the market is complex in the following way. 70% of all of the purchase orders we get come from institutions, either hospitals, hospital systems, or ambulatory surgical centers. The physicians have no idea what the price of the actual implant is. They don't buy it. You know what I mean? So it has nothing to do really with physicians. Physicians who are not employed by a hospital system they may buy some external trials, you know, they buy external trials for their office, okay, fine, the private docs. But that's, once again, only 30% of the customers that are out there, and the only thing they're buying from us is external trials. When it comes to the implant, you know, all of our purchase orders come from ASCs or hospitals, right? So, I mean, that's the kind of nature of the business. So we have more employed physicians than ever before. in general in the marketplace, and so on and so forth. So I think that if you just take a step back, the one good thing, you know, positive thing I can say about Medtronic is they're disciplined when it comes to price because they're an EPS-driven company. So, you know, why would they do something that is different than their character, right? And the other piece is Exonix, believe it or not, is actually expanding... the market and expanding Medtronic's business at the same time. And they have more market share than we do, right? And we're out there creating awareness and doing all this kind of stuff. So I think that this is a, you know, what's that expression? The rising tide is floating all boats here. And I think this is about TAM expansion. And we've been a little bit conservative about, you know, trying to make a big deal out of our point to it just because the data is squishy right now given the pandemic. So... You know, I think everyone should be thinking about this is a market expansion story. This is a TAM that is unbelievable. There's 80 million, you know, people out there that are suffering with these problems. We've only scratched the surface. So I think there is an enormous amount of blue sky and a big opportunity. And as we have said all along, you know, this, what Maxonics is, entry into the sacral neuromodulation market, has been the best thing, honestly, that has ever happened to Medtronic. Because now they've got, you know, better products than they had even three years ago, you know, on and on, and the market is expanding. So I just, we're just not anticipating any price pressure going forward. I mean, and keep it, this last piece in mind, off, sequential modulation products, for a full system sell for about $10,000 less than spinal cord stimulators. So these are not that expensive as compared to other products that are sold of a similar ilk in the market.
spk05: Okay, thanks. And then I think Dan called out some margin benefit from the mix of F15 versus the rechargeable. I know you're probably not going to quantify the difference in the gross margins, but can you maybe just talk about that a little bit, about how much more profitable the the F-15 is versus the rechargeable version.
spk11: Sure. So the margin benefit to Axonics on the F-15 product comes in two ways, which is one, it's a S&M system, but there's not a charging system. So you don't have to ship the charging station and the belt that holds it in place. The other thing is with the manufacturing process, we brought a number of steps in-house. into our Irvine manufacturing facility so we have better control over cost and throughput, which is also providing incremental margin.
spk05: Okay, great. Thanks.
spk10: Thanks, Mike. Thank you. And that concludes the Q&A portion of the conference. I would now like to turn the conference back to Raymond Cohen for closing remarks.
spk06: Thank you, operator. Look, we appreciate everybody listening in on the call today. Appreciate the questions. And we look forward to doing this again in the next couple of months. So you all have a good day and stay safe out there.
spk10: This concludes today's conference call. Thank you all for participating. You may now disconnect and have a pleasant day.
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