Axonics, Inc.

Thank you for standing by and welcome to the Axonics first quarter 2023 results conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you'll need to press star 1-1 on your telephone. To remove yourself from the queue, simply press star 1-1 again. As a reminder, today's program is being recorded. And now I'd like to introduce your host for today's program, Neil Balakar. Please go ahead, sir.

Thank you, Jonathan. Good afternoon, and thank you for joining Exonix's first quarter 2023 results conference call. Presenting on today's call are Raymond Cohen, Chief Executive Officer, and Dan Deren, President and Chief Financial Officer. Before we begin, I would like to remind listeners that statements made on this conference call that relate to future plans, events, prospects, or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 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 Ex Onyx'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 forward-looking statements. We speak only as of today's date, May 1st, 2023. 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. With that, I'd now like to turn the call over to Ray.

Thanks, Neal. And I'd like to welcome everyone who's joining this afternoon's call who may listen to the playback. Exxonix generated revenue of $71 million in the first quarter, an increase of 46% compared to the prior year period. More specifically, cyclone modulation revenue was $55.2 million, representing an increase of 41% compared to the prior year period. Revenue growth is being driven by a combination of higher utilization of our S&M systems in existing accounts and continued share gains from the addition of newly acquired competitive accounts. BulkMed revenue was $15.5 million, an increase of 66% compared to the prior year period. Results for BulkMed were driven by solid reorder rates from existing accounts, the onboarding of new accounts, and the addition of new sales representatives focused primarily on promoting BulkMed. BulkMed continues to rapidly gain traction in the U.S. and is fast becoming first-line therapy for women with stress urinary incontinence. It's also worth noting that despite the sequential step down in revenue from seasonality, we still generated positive adjusted EBITDA in the quarter. Now, Dan will discuss our financial performance and outlook in further detail in his prepared remarks. So I would now like to provide some updates on other corporate initiatives. Last week, we announced the acquisition of a lead placement technology that complements Exonic's existing sacral neuromodulation offering. Let me start by saying our business development strategy is to develop or acquire innovative technologies that enhance the physician and patient experience with the goal of increasing the penetration of advanced therapies for this vastly underpenetrated incontinence population. With that as a backdrop, as many of you know, physicians determine a patient's eligibility for long-term sacromodulation therapy by performing a short two- or three-day external trial or peripheral nerve evaluation, typically referred to as a PNE. In a PNE, the temporary lead is placed and is often done in an office setting without real-time imaging. Now, due to anatomic variability between patients, locating the appropriate sacral foramen closest to the desired root of the sacral nerve can be challenging without fluoroscopy. The acquired technology addresses this challenge with an elegant solution comprising of a software application and a hardware tool that makes the PNE lead placement easier, faster, and more accurate. The technology has the potential to reduce procedure time and facilitate a more accurate placement, which, in turn, can increase physicians' confidence in cyclone modulation procedure and drive increased therapy adoption, utilization, and the permanent implant conversion rates. With a standard x-ray of the patient's pelvis, a physician can leverage the software to determine the optimal location for needle entry and lead placement based on that patient's specific anatomy. The technology can readily be implemented into existing clinical workflows, as it takes only minutes to use and requires minimal training. Now, we believe this solution has the potential to drive increased utilization of cyclinomodulation therapy, and we're eager to get this technology into the marketplace. We expect the product to receive FDA clearance and to be commercially available by mid-2024. Now, turning to an update on our commercial team, We now have approximately 360 field-based personnel in the United States, of which 175 are directly involved in selling or sales management. The balance of our personnel are clinical specialists and field marketing specialists. Internationally, we have a more modest footprint with 25 field-based personnel located in Europe and a handful in Australia. We are well-staffed at this time and expect only a modest increase in our commercial team headcount during the remainder of 2023. Now turning to the Exxonix Find Real Relief DTC advertising campaign, many of our customers continue to tell us that patients come into their practices asking about Exxonix therapy after seeing our ads on television or on the internet. The campaign continues to generate goodwill with our physician customers as they are grateful that we are helping to ensure that adults with these conditions are being seen by a clinician and advancing along the care pathway. Qualified leads are those individuals that complete a symptom questionnaire on the website. We continue to generate over 10,000 leads each month and have found that over half of those individuals filling out these questionnaires are treatment naive, underscoring the notion that people don't know that it's not a normal part of aging to leak urine and that advanced therapies do exist to treat incontinence. Our call center continues to work diligently to connect qualified leads with a physician specialist in their local community. Now turning to product development initiatives, we recently received regulatory approval for the Exonix R20 rechargeable neurostimulator from the FDA in the month of January. The device utilizes the same small 5cc form factor as the R15, and requires recharging just once every 6 to 10 months for one hour. The device has an expected useful life in the body of at least 20 years. Feedback from customers that have implanted the device has been overwhelmingly positive. That said, the long-lived F15 recharge-free system continues to represent a significant portion of S&M sales in the United States. Now, this past week, we also introduced an electronic diary called MyExonics, which is now available for download for free in the Apple and Android app stores. While anyone can use the electronic diary, we developed it to move patients from paper diaries to an electronic format that allows us to upload diary results into our cloud-based patient care management portal. Since dire results are used to confirm a patient's eligibility for cyclinomodulation, being able to store these records for our customers is a nice service and is helpful with preauthorization and reimbursement processes. Now, in closing, we feel like we are just scratching the surface of what is possible in the large, underserved, underpenetrated markets in which we participate. Our mission-driven team remains committed to innovating and supporting our dedicated physician customers and their patients, as well as raising awareness of our best-in-class therapies. So with that said, I'd like to turn the call over to my colleague Dan for his detailed remarks on financial results. Dan?