Axonics Modulation Technologies Inc (NASDAQ:AXNX) Q4 2018 Earnings Conference Call Transcript

Mar 05, 2019 • 04:30 pm ET

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Axonics Modulation Technologies Inc (NASDAQ:AXNX) Q4 2018 Earnings Conference Call Transcript

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Presentation
Operator
Operator

Good day, ladies and gentlemen, and welcome to the Axonics Fourth Quarter and Year-End 2018 Results Conference Call. And at this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. (Operator Instructions) As a reminder, this conference call maybe recorded.

I would now like to introduce your host for today's conference Mr. Matt Clawson from W2O Group. Sir, you may begin.

Executive
Matt Clawson

Thank you very much, and thanks, everyone, for joining the Axonics quarterly results and update call. Joining me on the call from Axonics this afternoon are Ray Cohen, Chief Executive Officer; Dan Dearen, President and Chief Financial Officer; and Karen Noblett, MD, Chief Medical Officer. Ray and Dan will provide prepared remarks and commentary on the fourth quarter financial results and business update. And Dr. Noblett will provide details on the ARTISAN-SNM clinical study, followed by a Q&A session.

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 in the conference call, including the risks and uncertainties, disclosed in Axonics' filings with the Securities and Exchange Commission, all of which are available online at www.sec.gov.

Listeners are cautioned not only to place undue reliance on these forward-looking statements, which speak only as of today, March 5, 2019. Except as required by law, Axonics undertakes no obligation to update or revise any forward-looking statements to reflect new information, circumstances, unanticipated events that may arise.

With that said, I'd like to now turn the call over to Ray Cohen for his remarks. Ray, good afternoon.

Executive
Raymond W. Cohen

Thanks, Matt, and thank you to everyone who's dialing in for today's call and who will listen into the webcast.

So since our last call in December, I'm confident we provided evidence that Axonics is moving forward with velocity. We've continued to enrich our literature-based PMA with six month data from the ARTISAN-SNM pivotal clinical study. We've also submitted full-body MRI data to the FDA. We've gained momentum in our international business in the UK, the Netherlands and Canada. We've gained CE Mark for the full-body MRI labeling in Europe, which is expected to have a further positive impact. And we've continued to build out our US sales and marketing team in preparation for the US launch. We've also filed for a new PMA with the FDA for bowel dysfunction. And least but -- last but not least, we've enhanced our Board of Directors.

So I'll provide an update on these key initiatives on today's call. Dr. Noblett will speak to our clinical results. But first, similar to our Q3 call, Dan Dearen, our President and CFO, will