The company is developing a sacral nerve stimulation device to treat incontinence.
Irvine, Calif.-based Axonics said yesterday that its losses grew 95.6% to -$9.6 million, or -50¢ per share, on sales of $494,000 for the three months ended Dec. 31, 2018, compared with the same period in 2017. Analysts on The Street were expecting losses of -32¢ on sales of $220,000.
Full-year losses also grew, rising 86.0% to -$32.5 million, or -$4.64 per share, on sales growth of 452.3% to $707,000 compared with 2017. Analysts were looking for losses of -1.59 per share on sales of $440,000.
“We view the generation of $0.5 million of revenue in the fourth quarter, serving a handful of customers with a small team of sales professionals, to be a harbinger of things to come. We are seeking measurable market share gains in 2019 from our two primary markets in Europe, the United Kingdom and the Netherlands. The accounts we have secured in these markets are exceeding our expectations in terms of the percentage of SNM implants using the Axonics system. Moreover, we now have the only SNM device with full-body MRI labeling, an advantage that should aid us in gaining further traction,” CEO Raymond Cohen said in prepared remarks. “Our primary focus continues to be gaining FDA approval in the shortest possible timeframe. To that end, and based on interaction with the FDA, we determined our best course of action was to further enrich our current literature-based PMA with the full cohort of Artisan-SNM study data as well as the full-body MRI data. As we advance our regulatory strategy, we continue to press forward on our initiative to be fully prepared to execute a broad, fully staffed U.S. launch upon FDA approval. We are building a world-class team and have been pleased that many experienced neuromodulation and urology professionals view Axonics as an attractive place to work that represents an exciting career opportunity. Overall, we are making excellent progress on our key operational objectives.”
AXNX shares closed down -3.2% at $20.75 apiece yesterday and were down -3.0% to $20.22 each today in late-morning activity.