Good afternoon, ladies and gentlemen, and welcome to the Axonics Quarter Four 2021 Results Conference Call. I would like to turn the call over to your host, Mr. Neil Bhalodkar. You may begin. Thank you, Sarah. Good afternoon, and thank you for joining Axonics' quarterly results and update call. Presenting on today's call are Raymond Cohen, Chief Executive Officer, and Dan Dearen, President and Chief Financial Officer. Ray will provide introductory remarks on the fourth quarter, followed by Dan discussing in detail financial results in 2022 guidance. Ray will conclude our prepared remarks with updates on sales, marketing, and product development initiatives, followed by a Q&A session. 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 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 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, February 24, 2022. Except as required by law, Axonics 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 for his remarks. Okay, thank you, Neil. I'd like to welcome everyone who's joining the conference call this afternoon. We're very proud of our fourth quarter and fiscal 2021 results, considering the disruption COVID-19 has had on elective procedures in the healthcare facilities in the United States and of course, around the world. In addition to strong commercial execution, we made important progress on several strategic initiatives that position Axonics for durable growth for years to come. Turning to fourth quarter results, Axonics generated record net revenue of $53.1 million, representing an increase of 53% compared to 2020. Sacral neuromodulation revenue was $44.4 million in Q4 of 2021, an increase of 28% year-over-year, and a sequential increase of 11% compared to the third quarter of 2021. In fiscal year 2021, through a combination of market expansion and share capture, our sacral neuromodulation revenue grew by over 40% to $157 million, representing over 10,000 patients that were implanted during the year. With tens of millions of Americans affected by bladder and bowel incontinence, continued innovation and increased patient and physician awareness for sacral neuromodulation, we expect this market to grow by at least 15% annually over the next five years and turn into a $1.5 billion category. Now turning to Bulkamid, our unique biocompatible bulking hydrogel for stress urinary incontinence for women. Fourth quarter revenue was $8.7 million, an increase of 27% on a sequential basis. In the 10 months of 2021 that we own this asset, Bulkamid has improved the quality of life of over 20,000 women, propelling Axonics into the market leader in this category. We're just scratching the surface of what is possible in this large and highly under-penetrated stress urinary incontinence market. As it relates to the impact Omicron had on our business, we started seeing an impact in sacral neuromodulation procedure volumes in the second half of December. Similar to what you have heard from other companies, the significant increase in the Omicron cases continued into January and early February, resulting in cancellation and deferral of hundreds of sacral neuromodulation procedures. The impact in February moderated, and we are encouraged by the improving trend line and expect this positive momentum to continue into March. Given this impact from Omicron and the normal seasonality from the annual resetting of insurance deductibles, we expect sacral neuromodulation revenue in the first quarter to experience a decline in the mid- to high-teens as compared to the fourth quarter of 2021. Importantly, we expect cases that were deferred or canceled in December and early 2022 to be rescheduled throughout the year. As such, our outlook for growing SNM revenue by 25% in 2022 remains unchanged. With that, I'll turn the call over to Dan for a more detailed review of fourth quarter 2021 and the financial results as well as 2022 guidance. Dan, I'll give you a second. Thanks, Ray. In the fourth quarter of 2021, as Ray mentioned, Axonics generated net revenue of $53.1 million. This represents an increase of 53% compared to $34.8 million in the prior year period. Sacral neuromodulation net revenue was $44.4 million, 98% of which was generated in the United States. Bulkamid net revenue was $8.7 million, 67% of which was generated in the U.S. Gross profit for the fourth quarter of 2021 was $35.4 million, representing a gross margin of 66.6% compared to 63.6% in the prior year period. Total operating expenses for the fourth quarter of 2021 were $53.1 million. Included in operating expenses are $6.8 million of stock-based compensation expense and $2.1 million of intangibles amortization. Operating expenses totaled $33 million in the prior year period. Net loss for the fourth quarter of 2021 was $15.2 million, compared to a net loss of $11.3 million in the prior year period. Cash and cash equivalents were $220.9 million as of December 31, 2021. Turning to fiscal year 2022 guidance, we expect total company revenue of $234 million, an increase of 30% compared to fiscal year 2021. SNM revenue of $197 million, representing an increase of 25% compared to fiscal year 2021. Bulkamid revenue of $37 million, an increase of 63% compared to fiscal year 2021. We expect gross margin to increase 200 basis points year-over-year to approximately 66% in fiscal year 2022. We expect to benefit from higher fixed cost absorption and purchase price discounts, as well as lower cost of goods sold on our new recharge-free device, partially offset by higher prices along the supply chain. In fiscal year 2022, we expect operating expenses to total $260 million, including $35 million of non-cash expenses associated with depreciation, amortization, and stock-based compensation. The increase in operating expenses compared to 2021 is primarily being driven by investments we are making in direct-to-consumer advertising and growth in the headcount of our U.S. field sales team. We expect these investments to pay significant dividends in 2022 and the years to come. I will now turn the call back over to Ray for additional remarks. Thank you, Dan. I'd now like to provide updates on our product development and sales and marketing initiatives. Suffice it to say, we're very excited about what Axonics has on tap in 2022. On the product development front, we have engaged with the FDA on an interactive basis throughout our PMA submission for the newly developed Axonics recharge-free sacral neuromodulation system. We are very close to the finish line and anticipate FDA approval before the end of the first quarter. We expect to begin shipping the new device within days following FDA approval. We're confident that the introduction of our recharge-free device will continue to drive market expansion and advance Axonics on its path to market leadership. At over 15 years at typical stimulation settings and over 22 years on low-energy settings, this new device will have the longest functional life labeling of any non-rechargeable nerve stimulator the FDA has ever approved. This recharge-free system will have a positive impact on our business since many physicians have only known and implanted non-rechargeable sacral neuromodulation systems for the last two decades. As we did with the introduction of the first long-lived MRI-compatible rechargeable sacral neuromodulation system in late 2019, our new recharge-free INS sets a new standard for what is possible in sacral neuromodulation. The fully recharge-free system is full body 1.5T and 3 T MRI compatible and employs the same stimulation engine along with a wireless patient remote control that, unlike our competitor's device, does not require a communicator, nor does it require recharging or replacement batteries. In accounts that are loyal to Axonics, this new device will allow us to capture business we previously couldn't service. More importantly, having an SNM portfolio that now includes a recharge-free option will allow us to take another crack at competitive accounts that previously didn't come our way because the physician believed that a non-rechargeable system was best for their patients. In order to maximize the potential for an exceptional product launch and market share capture, we are ready to go with a full-scale market launch that includes running seminars around the United States in the second quarter. These seminars proved exceptionally successful when launching our first generation SNM system in late 2019 and Bulkamid in the second half of 2021. I would now like to spend a few minutes discussing the large and under-penetrated market opportunities our therapies address. Okay, I think we're back live now. There were some technical difficulties. I was speaking about our initial approach to raising awareness, which we still employ to this day. That is to encourage practices to identify patients that have been previously treated with drugs and/or Botox and are eligible for Axonics therapy. With our assistance, the practices then send mailers to these patients, which discuss the availability of a long-lived new device that is MRI compatible, highly efficacious, and easy to use. The program has been very successful and is one that provides a tremendous return on investment for both Axonics and our physician customers. We also reach patients via print advertising, radio, and a combination of digital activities, including Facebook ads, paid internet search, and search engine optimization. These various channels direct patients to Axonics-branded websites, where the person registers and then qualifies themselves based on answers to a short online symptom questionnaire. Now, we partner with a third-party call center that is staffed by a team of nurses well-versed in incontinence and the therapies we offer. This effort has resulted in over 50,000 inquiries last year and a few thousand qualified leads that were provided to physicians that offer Axonics therapy. Now, we've taken the learnings from the last two years of our direct-to-patient and direct-to-consumer efforts. We went to school on what has and hasn't worked for other med tech advertising campaigns, and we are now excited to take the next step in our DTC journey. Beginning in April, we will be airing television commercials locally and nationally on network television as well as streaming channels. Television will allow Axonics to reach millions of women in 2022 and potentially generate hundreds of thousands of inquiries. Our messaging will need not to distinguish between urge, stress, or fecal incontinence because we offer solutions for all of these conditions. We believe this will increase our response rates, lower cost per lead, and drive more patients into practices that offer Axonics therapy. Our omni-channel strategy will help establish the Axonics brand and allow us to engage patients with incontinence across multiple platforms with a consistent message that new life-changing incontinence therapies are available to them. It will also be clear to physicians that we are behaving like and plan to be the market leader in this category. To prepare and fully capitalize on the market growth and share capture we anticipate in both the near and long term, we have grown our U.S. field team to approximately 300 individuals. The team is evenly split between quota-carrying sales professionals and clinical specialists that support cases. We are confident that the breadth and depth of our team matches the market potential for sacral neuromodulation and stress urinary incontinence treatment for the next several years. In closing, we're grateful and humble for the trust physicians, patients, and shareholders have placed in Axonics. I'd also like to thank our 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. At this time, we're happy to take questions, and I'll turn it to the operator. Thank you, sir. Ladies and gentlemen, if you have a question at this time, please press the star and the number one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Your first question comes from the line of Larry Biegelsen from Wells Fargo. Your line is open. You may ask your question. Good afternoon. Thanks for taking the question. Ray, can you hear me okay? Yes. Thank you, Larry. Okay, great. I wanted to start on the primary cell device. You know, the information you shared tonight was interesting on the 15- to 20-year battery life, if I heard correctly. My question is, Ray, you know, how do you think your device is gonna stack up to what we've seen so far, you know, from the Medtronic new non-rechargeable device that they just got approval for? And are you gonna be able to market that 15- to 20-year claim, I think you mentioned on this call, if I heard correctly? I think they said theirs is about 10- to 15 years. I have one follow-up. Yeah, no problem. Larry, look, I think that there's no question that we're gonna be able to market the claim because that's the data that we submitted to the FDA, and they have already accepted our longevity claims based on our you know our robust internal testing and accelerated life testing. Just to give you a comparison you know to pick a point you know a 1 mA implant for us is gonna get 17.5 years out of our device, and that's typical parameter settings. We're really excited about that. We think it's gonna compare quite not only quite favorably, but once again, as I made in my prepared remarks, this is gonna be the longest time in terms of longevity in the body for any non-rechargeable neurostimulator that the FDA has ever approved. We're quite excited about that. Of course, you know, the product, I think very importantly, I mean, it uses the same clinician programmer, the same wireless patient remote. It's got the same engine, will have the same conditions for MRI compatibility that we have in our existing products. We think this is clearly going to set a new standard in sacral neuromodulation for what is possible. I'll just add by saying, of course, we're not abandoning by any means our long-lived rechargeable device, which could easily get over two decades in the body and currently only requires charging once a month for an hour. We're real bullish about this, Larry, and I think the key thing for us is to be able to offer, you know, the complete line and give physicians choice depending upon maybe the age of the patient or whatever other parameters they may decide to move a patient in one direction or another. We're agnostic from that standpoint. We just want them to, you know, implant Axonics. That's super helpful, Ray. Then just for my follow-up, on your DTC efforts, could you describe how much you're gonna spend in 2022, and what gives you the confidence you won't, you know, help your competitor more than yourself, you know, given that their share is still higher? Thanks for taking the question. Yeah. You broke up a bit. Hopefully, this line is not broken up. Larry, can you hear my response well? I can hear you fine. Okay. Do you want me to-- Just to re- No. I- I got it. No, no problem. I heard your question. Your question fundamentally was, you know, what gives us confidence that we're not gonna be advertising for our competitor, right? The answer is that we're not advertising sacral neuromodulation. We're advertising Axonics therapy for patients who have incontinence. I think that, you know, that's what we're doing. We feel pretty confident about that. You know, of course, you know, the rising tide, as we said all along, you know, floats all boats, right? You know, if this helps the category in general, we're okay with that. We're being smart about it. You know, we recognize that there is a competitive offering, and so, you know, we're purposely orienting our commercials so that we can pick up patients with any form of incontinence, whether it be stress or urinary or whatever the case might be. We're not gonna make those distinctions. Besides, in a 30-second commercial, you really can't. Further to that, just to give you a complete, fulsome answer, anytime somebody raises their hand, they're directed to a website. They fill out a survey if they're interested. Obviously, that's the first level of qualification. Then we have, as I mentioned in my remarks, a call center where people, you know, these are registered nurses who not only understand incontinence, but they understand our offering. They'll call out to those patients, speak with them about their condition, and then offer them an opportunity to get connected to a center that is offering Axonics therapy. This is not about sending people to a website, putting a physician locator on it, and letting patients decide, you know, who they wanna go to, willy-nilly. We've had a lot of experience with this over the last year, and we feel like we've got that system down, and you know, we'll be getting the right kind of return on our investment. Thanks a lot, Ray. Thanks for taking the questions. Thank you, Larry. Appreciate it. Your next question comes from the line of Chris Pasquale from Guggenheim. Your line is open. Thanks. Appreciate you taking the questions. Ray, you said you're just scratching the surface of what you can do with Bulkamid. What else can you do there? Are there product line extensions or clinical trials you wanna pursue that you think could drive more adoption, or is it just about touching more physicians? Thanks, Chris. That's a good question. We don't need to do anything. I mean, this is. We have physicians that are evangelizing the therapy based on the results that they're seeing with the patients. I mean, this is a phenomenal alternative that anybody who is coughing, sneezing, pick up objects, exercising and leaking urine. I mean, we can get them fixed up in 15 minutes, you know, whether it's in an office, ambulatory surgery center or outpatient section of a hospital. So for us, it's just more about going out there with our team and accessing more of these accounts and giving them access to the product. This thing is growing like weeds, as you've seen already, and there's no pushback in terms of a, the quality of the product, the ease of administration, the immediate results that patients are getting. We don't have a burden to really do anything else other than go out there and offer this product and support these customers. This thing's got legs, and I think we've seen that already and we expect you know the revenue just to continue to flow in and obviously provides us with a lot of other benefits besides just the revenue and the margin. Got it. Okay. Dan, if I heard you right, you're guiding to a roughly $70 million increase in OpEx on a roughly $50 million increase in revenue. It certainly makes sense to invest in the future growth of the business, but that seems like quite a bit of investment or sort of negative leverage in this year in particular. Can you talk a little bit about where that's going and you know, how you think about this level of spending? Is this a one-time you know, investment year, then we start to see leverage as we get into 2023? I think that's right. I don't think I'd characterize it as one time. I think at a high level, there's obviously increases across a number of departments as we scale up and have just more activity. Obviously the big drivers, as you've called out, are the DTC campaign in addition to other marketing programs. You know, I think we glanced off of this on the call but didn't get into it, but we've also added a number of sales reps and clinical specialists in the U.S. field sales team. You know, as a secondary, since you brought up Bulkamid, we started out, you know, with four U.S., what we call, key account managers, which are the Bulkamid reps, and we now have increased that to 25. What you're seeing is, you know, increase in spending across a number of departments, primarily focused on revenue generation. We are talking about a sizable, you know, certainly for us, increase in DTC spending. It's the type of program we're gonna push hard as long as we see return on investment and revenue growth. Look, when we optimize it in regional and local territories, then we'll be able to cut back on some of the bigger expenses. It's the type of program that, you know, we don't know if it runs for, you know, one year, two years or three years, but at some point the leverage will come in because it will take some patients some time to go through the process and the care pathway to get implanted. It's the type of investment that will produce returns for the next, you know, one, two or three years. Got it. Thanks. Thank you. Your next question comes from the line of Cecilia Furlong from Morgan Stanley. Your line is open. You may ask your question. Great. Thank you for taking the questions. I wanted to start just with the revenue guidance, understanding the sequential dynamics in the SNM business. Could you just talk about, one, what you're expecting from Bulkamid, 4Q to 1Q, and then throughout the balance of 2022, as well as how you incorporated the launch of the recharge-free platform and your thinking in terms of sequential acceleration in the business through the balance of the year? Certainly. For 2022, as we said, we expect total revenue of $234 million, and that's both sacral neuromodulation as well as Bulkamid. The SNM piece is $197 million of that, which represents 25% year-over-year growth. We're expecting in Q1 a mid- to high-teens sequential decline compared to the fourth quarter, and that's due to seasonality and also the Omicron variant, which is in certain markets hampered elective procedures. We look forward at quarters two through four in 2022, when you factor in seasonality, we expect the SNM revenue in the second and third quarters to have roughly equal weighting of 25% of the total revenue. Then the fourth quarter, which is always strongest, to be approximately 30% of the total revenue. On the Bulkamid side, what we're expecting to see in Q1 is a slight decrease from Q4 of 2021 of just a couple $100,000. Then we expect to see that increase quarter-over-quarter by approximately $500,000 each, which is how we get to $37 million in revenue for 2022 for Bulkamid. Okay, great. Thank you. If I could also just follow up. As you think about the initial launch of the recharge free platform, how you're thinking about either targeting accounts where you have the majority of share, Medtronic, sell as a portion, versus those accounts that maybe you've been leveraging Bulkamid to get into where you haven't had a presence before, but just the ability now to have the recharge free platform in your portfolio. I'm just curious if you could provide some high-level commentary around how you think about that initial launch. Thank you. Sure. Ce, this is Ray now. You know, it's pretty straightforward. As we've said before, it's not as if our existing accounts are clamoring for a non-rechargeable device, okay? I think this is important to say. We've got, you know, happy customers. They're implanting our device. I mean, you know, 10,000 of our devices got implanted last year alone, you know, 98.5% of that in the United States. You know, will we get some business on the margin? You know, are there some patients that are in Axonics loyalist accounts that still wind up with an InterStim II because they may have had one in their body before? You know, there's some of that that's going on, and clearly we have some accounts that have been splitting their volume. We'll see some incremental increase in the existing accounts that we have today. Now, as you mentioned, Cecilia, appropriately, you know, our target is competitive accounts. We have quite a number that have been waiting, right, for us to come out with this new product that we haven't gotten any business from. We're gonna target them, of course. A lot of those accounts, interestingly enough, have started with Bulkamid. We're already behind the counter, so to speak. It's, you know, it's a combination of all those activities. As you probably know, you know, salespeople are a special breed of cat. They follow the path of least resistance. You know, that's the guidance, right? Let's get the business where we can get it and, you know, try to light up the scoreboard the best that we can. For us, you know, we're just very thankful that, you know, the pandemic seems to be receding. Things are, you know, opening up nicely around the country. There's still a little bit of a hangover, clearly. We got a lot of patients that we're hoping that we'll reschedule their procedures now that the hospitals and ASCs are, you know, open to doing procedures. You know, we're very optimistic about things, and we think that, you know, the only thing that's held us back, quite frankly, has been the pandemic. You know, with that receding and with you know, the new product offering and you know, additional stuff that we have planned for this year, along with the advertising, you know, we're quite bullish about what 2022 will offer for Axonics. Great. Thank you very much for taking the questions. Absolutely. My pleasure. Thank you. Your next question comes from the line of Adam Maeder from Piper Sandler. Your line is open. Hey, Ray. Hey, Dan. Thanks for taking the questions, and congrats on the progress. Wanted to start on the primary cell device, and maybe you could just level set us for, you know, the market today. How is that split between rechargeable and non-rechargeable therapy? And then the second part of the question is if you were to look forward kinda 12 months from now, Ray, I mean, how do you think your device mix will stack up, recharge versus recharge-free? And then I had a follow-up. Sure. You know, I just wanna make a point. We talk about a recharge-free system. We're talking about a recharge-free system where neither the IPG, which is implanted in the body, or the patient remote needs to be recharged. That is not the same offering that our competitor has. It's true that you don't have to recharge their IPG, but the rest of the accoutrements all need to be plugged in the wall and recharged on a regular basis. I'm gonna answer your question backwards, Adam, if you don't mind. We would expect that, you know, given a year or so from now, we probably will see a 50/50 split in terms of our non-rechargeable versus rechargeable product. You know, maybe that's not the most enlightened projection, but probably can't be too far off one way or another if we stick with the 50/50 idea. So that's ultimately I think where this thing goes. Now, your question about, you know, what is currently the case in the marketplace. You know, I think it's important to kind of remind people that the number one selling product in the United States, in the world, has been the InterStim II, right? That's the product that we've been competing with. It is a non-rechargeable device. We just have not seen much penetration of the competitor's rechargeable system, okay? You know, have they sold some? Sure. But once again, the product that we've been competing with has been InterStim II. We continue to replace those products. Nearly 15% of our overall volume is still replacements of these legacy products in these physician offices. I think we'll pick up more of that business as time goes on now that we have a long-lived non-rechargeable system to offer. You know, there are two markets. I think this is really important for people to understand. There's one, you know, there's a physician who's communicating with their patients and trying to move those patients in the best direction that they can, right? It's not like, you know, patients are coming in with a strong preference per se. You know, we've done surveys about this and what the patients tell us is they're following the advice of their physician, and that shouldn't surprise anybody. Really helpful color, Ray. Appreciate all that. For the follow-up, wanted to ask about the recent journal publication that talked about, you know, higher prevalence than previously anticipated on incontinence, and how you think that could potentially benefit therapies like sacral neuromodulation, Bulkamid. I think the journal article talked about the need for routine screening as part of preventative care for all adult women. You know, is this a tailwind for the category? Is this something that could have a light switch effect? Is it something that kind of just benefits the category over time? Just any color there would be helpful. Yeah. Thank you. Yeah, thanks, Adam. That's a good question. I wish I could say that anything in medicine is light switch, but it's not. As you know, things change very slowly. You know, it's unfortunate. I say it's unfortunate because here's the fundamental problem we have. Primary care physicians have no idea about sacral neuromodulation. Primary care, OBGYNs don't treat, for the most part, you know, urinary incontinence, right? This is part of the problem. What we're looking to do here is not just stimulate the urology and urogynecology market. These are the docs that are actually offering these therapies. We also want, with our advertising, to stimulate the market in general, right? We hope that, you know, if patients are coming into their regular doctor, and as you know, women mainly see GYNs, and if they're walking in these offices and they're saying, "Look, I'm leaking, and I saw an ad on television, how can you help me?" Either that stimulates them to get in the game to do Bulkamid or to refer that patient out to a urogynecologist, as an example. You know, there is so much blue sky in this category, it's truly unbelievable. We're sitting on top of a unicorn opportunity with a TAM that is really quite unbelievable. I think that it's been, quite frankly, a very sleepy corner of our business up until this point. We aim to change that. Given these, the prevalence and incidence of these problems that exist out there, we think that, you know, creating some buzz out in the marketplace, particularly among potential patients that now are gonna hear for the first time there's actually a solution. I dare say this is very analogous to what we've seen from Inspire, right? Nobody knew that there was a neuromodulation device that could treat sleep apnea, but now with their cute commercials, you know, if you're using CPAP, you're thinking, "Hmm, maybe I should go look into this other product." This is a well-kept secret. We've been banging that drum. Dan and I have been talking about this now for eight years, and we've been banging the drum, and I think now is it's one of those situations where I think it's the right time, the right, we have the right technology now. We've got, you know, we're gonna have that full line of products for people to choose from. We don't care what kind of incontinence you have, we can get you treated, and I think we've positioned Axonics quite nicely to benefit from additional awareness in the marketplace. I really appreciate that question, Adam. It gave me a chance to say a few more things I wanted to talk about. Thanks for the color, Ray. Yeah. Your next question comes from the line of Mike Matson from Needham & Company. Your line is open. Thanks for taking my question. You know, it seemed like the fourth quarter, there was a bit more of a divergence between your performance and Medtronic. I mean, they even admitted that they lost share in the quarter. What I'm wondering is, you know, did something change? I mean, is it the sales force expansion? Is it the Bulkamid strategy of cross-selling? You know, is there something going on there? 'Cause, you know, there wasn't any change from a product perspective, at least at that point in time. Mike, we got great products. We got great people. We provide exceptional service, and it's just a matter of time. I think that, you know, look, we've only been at this for a short period of time. I mean, just to remind people, we launched our product in November 2019. We had four months where we were not impacted by a global pandemic. Ever since that day, Mike, we've been under that cloud. I think what you're seeing now is, you know, here we are. It's been basically not even two full years, but it's been two years since we've been out there, you know, calling on these practices. I dare say that, you know, we're not going anywhere, right? That we are turning our customers into raving fans of Axonics. They love our people. They love the quality of the product. They're getting better results than they've ever seen in this category. Our Bulkamid product now is being able to literally cure stress urinary incontinence, at least for the next five or seven years after these injections. I think you're just starting to see the momentum building around the Axonics brand and people recognizing that we do business in a different way. When we talk about, you know, one of our mantras is no patient left behind, I mean, this is something that really resonates with our customers. They understand that we actually care about these patients. We wanna make sure that they're gonna continue to do well over time. It's not about selling something and walking away and leaving it up to chance. We're really committed, and we're working very hard with these practices to embed our people there, so that they're confident, you know, about not only the quality of the products, but that they get to know, you know, our people and their commitment and so forth. Mike, I just think it's, quite frankly, a result. You know, our Q4 numbers and the fact that we're making serious progress in the market is a result of a million little things that we've been doing, you know, since we launched this product in the United States. Okay. Makes a lot of sense. With regard to the TV campaign that you mentioned, you know, how is that gonna be sort of rolled out? I can't imagine you're gonna go national all at once, or maybe you are. You know, what sort of metrics are you gonna use to kind of judge the performance? Well, you know, look, we are going national to start. I mean, we're not playing around with this. This is a serious undertaking. We've spent a lot of time and energy on the messaging and making sure that we feel confident about, you know, what the ad's gonna look like and all the rest, and we're gonna make a big splash with this, and so forth. Now, initially, the only real metric that you can measure is gonna be response rates. It's gonna be how many people, you know, are actually going to those specialty websites and qualifying themselves and filling out the survey. That's gonna be the first thing that we're gonna be looking at. We have a pretty good sense about what to expect. In measuring how many of those. The next thing we'll measure is how many of those individuals can we actually place with an appointment into an Axonics account, right? That's gonna be the two top metrics that we're gonna look at first. We're gonna have to be a little bit patient because once again, these are people with a problem. We don't know, have they taken drugs? Have they failed drugs? Have they tried Botox? We have no idea. They're gonna have to work their way through the care pathway, as Dan mentioned earlier. Some people are gonna be ready for procedures right away. Others are gonna need to go through the process of being differentially diagnosed, and then maybe taking some drugs for OAB or, you know, having a conversation about stress urinary incontinence and what their options are and so on and so forth. It'll take some time, and we won't be shy about reporting back out. You know, we gotta see how it's gonna go first. Nobody's ever done this in this category before, so it's kind of a little bit of the brave new world. Okay, great. Thank you. Sure. Your next question comes from the line of David Rescott from Truist Securities. Your line is open. Hey, Ray. Thanks for taking the questions. Wanted to start off on guidance and just get your thoughts behind the approach to guiding this $234 million revenue estimate for the year, rather than a range. If I heard you correctly, I think in the prepared remarks, you mentioned that there were canceled SNM procedures that are expected to be rescheduled throughout the year. I guess my question is, what level of visibility do you have into the business, and how should we read into this guidance number when we think about the level of existing backlog or those expected to be rescheduled this year, versus those that are newly scheduled throughout the course of the year? Well, I mean, I'm not really exactly sure. I'm looking at Dan on how to answer that question, other than to say, look, we gave you what we think is our best estimate. We felt that providing a range doesn't provide us with really any upside, because if we put the range, everybody's gonna expect the high end of that number. You know, if we come in at the low end of the number, then everybody's gonna be disappointed. We just basically put forth what we think we can do, and obviously, as is the case with any management team, our objective is to beat those numbers. In terms of visibility, you know, this is a different kind of a pipeline, right? We're not selling capital equipment where, you know, you have X amount of prospects and, you know, you're waiting for the purchase orders and things of that nature. I mean, this is a very fast-paced, volatile business where patients walk in the door. You know what I mean? Ultimately, you know, we gotta get them treated. It's not. You know, we have a lot of metrics. Of course, all our analytics are looking backwards, right? I mean, that's the key thing. We have a good sense, right? Of, you know, how many procedures each of our accounts are doing. We've had plenty of surveys that have been done either by ourselves or the analyst community or institutional investors themselves. The feedback from our customers is that they expect the market to grow significantly as this pandemic recedes. Hopefully, you know, what we're talking about, you know, growing your business 30% year-over-year is never that easy. It's not like you wake up and, you know, just look at the scoreboard. We think there's plenty of potential for us to exceed, you know, what we've put forth. Okay. I guess on Bulkamid, you know, it's the sales force are fully kind of trained in Bulkamid a few quarters in the bag. In the past year, we've talked about this as having halo effect or in your words, you know, being catnip for some of these new SNM accounts. I guess my first question is what level of pull-through have you seen so far within SNM accounts? The second question to that, you know, is it possible to think about maybe a more material halo effect within the SNM business bearing fruit in the second half of 2022, you know, if that SNM business is more impacted by Omicron in the near term? I guess, you know, if I were to ask it a different way, are there SNM accounts now that are being activated, that were pulled in because of Bulkamid that may just not ramp in the near term because of COVID, or staffing shortages that may more materially do so in the second half of the year? I think if I simplified, you know, the question, clearly we believe the second half of the year is gonna be more fruitful. We're optimistic that the second quarter of this year will be, you know, as good, as we experienced in the second quarter of last year, right? That was probably a good clean quarter for us. We don't think we have to wait until summertime, to see, you know, an uptick in the business. We think our customers are anxious to get patients treated, and as long as the elective procedures are open, then I don't see any reason why, you know, we can't get these patients in and get them treated. There's no question that Bulkamid has been contributing to the halo effect as you referred to it, and we've talked about it in the past and has gotten into a lot more accounts. I think you know, we're gonna see really the fruits of that labor. We've seen some already, of course in Q4, but we're gonna see the fruits of that labor in 2022. That's really where we're gonna start to you know, how should we say, reap the benefits of having this expanded product line and being able to treat you know, all these types of patients with incontinence. There's no doubt that it's worked well. The seminars that we ran for Bulkamid last year yielded quite amazing results in terms of the number of physicians that have started. We had 328 people attend these seminars. I think the latest numbers I've seen is that we have about 80% of those physicians that attended are actually treating patients with Bulkamid already. We've picked up, you know, a few dozen accounts because of this, in places, in accounts that we weren't in before. We expect that trend to continue, particularly now, or as soon as we get the approval on the, you know, recharge-free system. Hopefully that, you know, we'll start to see, you know, the fruits of all of our labor really, you know, come to bear in 2022. All right. Very helpful. Thanks for taking the questions. Thank you. Again, ladies and gentlemen, if you have questions at this time, please press star under the number one on your touchtone telephone. Your next question comes from the line of Danielle Antalffy from SVB Leerink. Your line is open. Hey, good afternoon, guys. Thanks so much for taking the question. Ray, I just have a high-level question and then a more specific question. High-level, you know, I think even through a pandemic, it's safe to say your U.S. launch has exceeded expectations. Is there a way to quantify or even qualitatively ascertain how much growth has come from market share gains versus market expansion? I guess, you know, are market share gains still a meaningful part of the growth story? Or how much of the low-hanging fruit has been had already from a market share perspective? You know, it's funny, Danielle. You know, you're asking us about market share when we have, there's only one part of the equation that we know, which is our revenue. Right. Right. We don't know the revenue from the other part. You know, the fact that there was a comment about, you know, that they gave up market share to Axonics in this most recent quarter, you know, I mean, it's not a surprise to us. The only surprise was actually the admission. We still don't have a number. It's really impossible for me to answer that question. You know, I mean, we've said that we think it'll be a combination, right? Of expansion of the market and market share gains. If you decode our 25%, like Blake said, we think the market will grow at least 15%, and we'll pick up the rest of the market share gain. I think we've kind of given the answer. Honestly, we're trying to talk about this with literally one hand tied behind our back because, you know, we don't have the other numbers. Yeah. Yeah. What I was gonna add is what we're seeing across the entire customer base is an increase in annual unit volume. What's not surprising to us, but I think probably interesting to people on the call, is we're also seeing a number of physicians now that have maybe, you know, not really been practicing SNM for a long time now asking to get retrained by us and to get back practicing this therapy. You know, I would say if there's any surprise post-commercial launch from 2019, it has been the market's more underserved and larger than we originally expected. This latest data that Ray talked about on the prepared remarks of the 78 million women in the U.S. that suffer from incontinence, you know, is substantially higher than what we were operating off when we went public. I think, you know, the blue sky that's in front of, you know, the two SNM players is vast, and this market's gonna continue to grow for the next five-seven years. Yep, got it. Okay. You know, Ray, this is maybe an unfair question because it sounds like it's hard to say, but I was just curious how sticky the market share gains you have made versus Medtronic have been. I don't, I guess maybe a way to ask the question is, in accounts where you've gotten traction, how sticky has the share been, since Medtronic has launched a rechargeable device? Thanks so much. We just have not had any impact from the competitive rechargeable product. We cannot ascertain any impact, quite frankly. I'm sure that, you know, accounts that are loyal to our competitor, you know, I'm sure they've tried that or to some extent may have tried that product, but it's been a non-issue for us. I think the only time when we saw some accounts go back the other direction was back in 2020, when the competitive product got MRI compatibility claims, right? That was the last time that we actually saw accounts, some accounts that had started with us that kind of switched back. Since then, we just haven't seen that. Hopefully that's, you know, direct answer to your question. Most of the action that we see is it's like what Dan said, where we've got new people that are wanting to get in the game for the first time, and now in 2021 and in 2022, we can train somebody up. We didn't have that capability per se back in 2020 when we first launched, nor was it a focus of ours. And then also, you know, competitive accounts that, you know, wanna work with Axonics because they've heard from their colleagues about the quality of our products and the quality of our people and the fact that, you know, we pay a lot of attention to every account, and we're there for every procedure, and we make sure that every patient is programmed well and is followed up. You know, that's the game, right? You know, and we think we're doing business in the right way, and that's gonna continue to accrue to our benefit over time. Thank you very much. Thank you. Appreciate the questions. I'm showing no further question at this time. I would now like to turn the conference back to Raymond Cohen. Thank you, operator, and thank you for everyone for listening in today. We appreciate all the questions from the analyst community, and we look forward to speaking with you all again. Bye bye now. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation, and have a wonderful day. You may all disconnect.
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