Axonics, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Exonix Quarter 3 2021 results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to turn the call over to Mr. Neal Valadkar to host our conference today. You may begin.

Thank you. Good afternoon and thank you for joining Exonix's quarterly results and update call. Presenting on today's call are Raymond Cohen, Chief Executive Officer, and Dan Deren, President and Chief Financial Officer. Ray and Dan will provide prepared remarks on financial results, commercial progress, and a general business update, 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 Exxonix'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, which speak only as of today's date, November 4, 2021. 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'd now like to turn the call over to Ray for his remarks.

Thanks, Neil. I'd like to welcome everyone joining the conference call this afternoon. In the third quarter of 2021, despite significant disruptions to our business from COVID-19, Exxonix generated net revenue of $46.9 million, representing 33% growth compared to the prior year period. When we held our second quarter conference call on August the 5th, we noted that a modest number of cases had been canceled in July and early August, and that our 2021 guidance assumed no further deterioration in elective procedure environment during the quarter. Unfortunately, a significant increase in COVID-19 due to the Delta variant led to cancellations and deferrals of numerous S&M procedures in the third quarter. Some patients were reluctant to undergo a procedure and canceled their external trials and or permanent implants. More impactful were the dozens of hospitals that restricted elective procedures due to a relocation of resources to the ICU, and more recently, the impact of nursing shortages across the country. These factors became more prevalent in August and continued into September. Many states were disrupted with a widespread impact in the southeast, with major markets such as Florida and Texas being particularly impacted. While the COVID infection rates have gone down, the pandemic and staffing shortages continue to impact our procedure volumes in October. As such, we have revised our fiscal year 2021 revenue guidance to $177 million, which Dan will discuss further in his prepared remarks. So turning back to the third quarter, second home modulation revenue was $40.1 million, which was flat sequentially. We consider this to be a solid and respectable result considering the Delta variant headwinds, summer vacation seasonality, and the other factors that I previously mentioned. We continue to add new accounts in the quarter, and we estimate that our market share held steadily or in perhaps even grew modestly. BulkMed revenue was 6.8 million of which 57% or 3.9 million was generated in the United States. It's clear that this fast and easy office-based procedure is significantly more insulated from the COVID surge as compared to sacral no modulation and other facility-based outpatient elective procedures. Physician response to BulkMed has been overwhelmingly positive. And as anticipated, the expanding offering has elevated exonics' stature within the urology and urogynecology community. While we see only modest growth for BocaMed in international markets going forward, we expect robust growth in the United States to continue for years to come, given how highly undertreated stress urinary incontinence is. Over the last four months, we have expanded our commercial footprint in the United States by adding more field-based salespeople and clinical specialists. Our U.S. field team now numbers 260 people. Over the last few months, we've also hosted over 325 physicians at six regional seminars to introduce Bulkamed and provide proctored wet lab training. The seminars also provided us with an opportunity to introduce our cyclone modulation system to physicians who are not yet our customers and have them hear firsthand from their peers who have already experienced the difference of working with exonics. The positive feedback from attendees has been exceptional, and we fully expect that these efforts will pay dividends for us in the quarters ahead as more physicians begin implanting exonics for their patients suffering from bladder and bowel dysfunction. On the product development front, As previously announced in late June, we filed a PMA supplement with the FDA for our newly developed, long-lived, recharge-free sacral neuromodulation system. We're engaged with the agency on an interactive basis and continue to anticipate receiving FDA approval during the first half of 2022, at which time we fully expect to begin shipping the new non-rechargeable S&M system to customers in the United States. We're confident that the introduction of a recharge-free device will continue to drive market expansion and advance us on our path to cyclone no modulation market leadership. With that said, I'd like to turn the call over to Dan to review Axonix's third quarter 2021 financial results.