Axonics, Inc.

Good afternoon, ladies and gentlemen, and welcome to the Axonics Quarter 4 2021 Results Conference Call. I would like to turn the call over to your host, Mr. Anil Balogar. 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 Duren, 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 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 forward-looking statements, which speak only as of today's date, February 24, 2022. Except as required by law, Axonix 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, and I'd like to welcome everyone who's joining the conference call this afternoon. So 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 Exonix for durable growth for years to come. Turning to fourth quarter results, Exonix generated record net revenue of $53.1 million, representing an increase of 53% compared to 2020. Sequential modulation 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 saquenal modulation 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 saquenal modulation, We expect this market to grow by at least 15% annually over the next five years and turn into a $1.5 billion category. So now turning to Bulkamed, 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, BocaMed has improved the quality of life of over 20,000 women, propelling exonics into the market leader in this category. And 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 Omnicron had on our business, we started seeing an impact in sequenomodulation 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 psychonormodulation 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 no modulation 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. And as such, our outlook for growing S&M 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 financial results, as well as 2022 guidance. Dan, I'll give you a second.