Axonics Modulation Technologies, Inc. (Nasdaq: AXNX), a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, today reported results for the fourth quarter and fiscal year ended December 31, 2020.

Raymond W. Cohen, Axonics CEO, said, “In the first year of Axonics’ commercial launch in the United States, we exceeded our ambitious goals despite the pandemic and only having approximately ten months of selling time. We are grateful for the overwhelmingly positive response from physicians and patients to the introduction of our r-SNM System. We look forward to more Americans getting vaccinated and a return to a more normalized elective procedure environment in which we can take full advantage of the strong growth outlook for Axonics and the SNM market.”

Fourth Quarter 2020 Financial Results

Net revenue was $34.8 million in the fourth quarter 2020, as compared to net revenue of $9.9 million for the same period of the prior year. Net revenue was consistent with the preliminary revenue result Axonics previously reported in January. U.S. net revenue accounted for $33.7 million, with select international markets accounting for $1.1 million of net revenue.

Management estimates that in the fourth quarter 2020, approximately 320 confirmed and scheduled permanent implants were canceled due to COVID-19 based upon a detailed territory by territory analysis. These cancellations represented approximately $5 million of revenue that was not recognized in fourth quarter 2020. Management expects the majority of deferred cases to be rescheduled for the second half of 2021 as more individuals are vaccinated.

Gross margin was 63.6% in the fourth quarter 2020, as compared to 54.4% for the same period of the prior year.

Operating expenses were $33.0 million in the fourth quarter 2020, as compared to $28.1 million for the same period of the prior year.

Net loss was $11.3 million in the fourth quarter 2020, as compared to a net loss of $22.8 million for the same period of the prior year.

As of December 31, 2020, cash and cash equivalents were $241.2 million.

Fiscal Year 2020 Financial Results

Net revenue was $111.5 million in fiscal year 2020, as compared to net revenue of $13.8 million in fiscal year 2019. U.S. net revenue accounted for $107.5 million, with select international markets accounting for $4.0 million of net revenue.

Gross margin was 60.2% in fiscal year 2020, as compared to 53.0% in fiscal year 2019.

Operating expenses were $120.9 million in fiscal year 2020, as compared to $87.9 million in fiscal year 2019.

Net loss was $54.9 million in fiscal year 2020, as compared to a net loss of $79.9 million in fiscal year 2019.

Clinical and Regulatory Highlights

On October 5, 2020, Axonics published survey results of patients treated with the Axonics r-SNM System that were previously implanted with InterStim™ II.

On October 20, 2020, Axonics launched the ARTISTRY study, a post-market clinical registry following patients treated with the Axonics r-SNM System.

On October 29, 2020, Axonics announced the submission of a premarket approval supplement to the FDA for the purpose of gaining detachable extremity coil MRI conditional labeling for 1.5T and 3.0T MR scanners. The filing is currently under review by FDA.

On November 10, 2020, Axonics announced the publication of fecal incontinence study results for patients treated with its r-SNM System.

On January 28, 2021, a manuscript was published online in Neurourology and Urodynamics discussing the two-year outcomes of the ARTISAN-SNM study.

On February 16, 2021, Axonics announced FDA approval of its third-generation implantable neurostimulator. 

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