Axonics Receives FDA Approval For F15

Axonics, Inc. (NASDAQ:AXNX) made an announcement yesterday, according to which it received FDA approval for its non-rechargeable (primary cell) SNM system called F15. According to the analysts at Needham & co, the approval closes a portfolio gap and could drive the next leg of SNM market share gains for the company. The timing is in line with the previous commentary that suggested approval during Q1/22, and management expects to begin shipping F15 units in April.

The analysts believe that the company’s revenue growth should be driven by both market expansion and market share gains from the launches of Axonics rechargeable and non-rechargeable r-SNM systems. In addition, the analysts expect Bulkamid to supplement Axonics' growth in its core SNM business. Over time, the analysts expect improvement in Axonics' gross and operating margins and for it to become profitable and cash-flow positive.

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