Axonics® Reports First Quarter 2021 Financial Results

Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today reported financial results for the first quarter ended March 31, 2021.

“This quarter’s revenue result reflects growing demand for our long-lived r-SNM^® system and Bulkamid^® despite the resurgence of COVID cases in the U.S. in early 2021 and ongoing lockdowns in Europe,” said Raymond W. Cohen, CEO of Axonics. “Physician and patient satisfaction remains high and Axonics is poised to take full advantage of the strong growth outlook for sacral neuromodulation as the vaccine rollout continues and we return to a more normalized elective procedure environment.”

Cohen continued, “Response to our recent acquisition of Bulkamid has been overwhelmingly positive. As anticipated, the expanded offering has elevated Axonics’ value proposition to the urology and urogynecology community. Clinicians are enthusiastic to offer this safe and efficacious next-generation bulking agent to women suffering from stress urinary incontinence. Physicians working with Axonics now have a complete set of tools to treat patients presenting with stress urinary incontinence, urge urinary incontinence, mixed incontinence, urge urinary frequency as well as bowel incontinence. Integration and training is ongoing and anticipated to be completed during the second quarter, allowing us to leverage our 250-person field team and position Axonics for a strong second half of 2021.”

First Quarter 2021 Financial Results

• Net revenue was $34.4 million in the first quarter 2021, an increase of 31% compared to $26.3 million in the prior year period.
  • Sacral neuromodulation revenue was $32.9 million, of which $31.7 million was generated in the U.S. and the remainder in select international markets.
  • Bulkamid revenue for March¹ was $1.5 million, of which $0.6 million was generated in the U.S. and the remainder in international markets.
• Gross margin was 59.3% in the first quarter 2021 compared to 62.4% in the prior year period.
• Operating expenses were $42.0 million in the first quarter 2021 compared to $31.1 million in the prior year period. Excluding one-time acquisition-related costs and amortization of intangibles, operating expenses were $36.9 million.
• Net loss was $22.5 million in the first quarter 2021 compared to a net loss of $14.6 million in the prior year period.
• As of March 31, 2021, cash and cash equivalents were $131.0 million.

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1 The acquisition of Bulkamid was completed on February 25, 2021. Reported revenue includes sales from February 26, 2021 onwards.

First Quarter 2021 Corporate Highlights

• 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.
• On March 2, 2021, Axonics announced a strategic alliance for the manufacture of its new non-rechargeable implantable sacral neuromodulation device.

Fiscal Year 2021 Financial Outlook

Axonics anticipates fiscal year 2021 net revenue to be in the range of $176 million to $180 million, which would represent growth of approximately 58% to 61% compared to fiscal year 2020 net revenue of $111.5 million.

Webcast and Conference Call

Axonics will host a conference call today, May 6, 2021, at 4:30 p.m. Eastern Time, to discuss financial results and recent business developments. The live teleconference may be accessed by dialing 866-687-5771 (U.S.) or 409-217-8725 (International) and using passcode 3749952.

The live webcast of the conference call may be accessed by visiting the Events & Presentations section of the Axonics investor relations website. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Axonics website.

About Axonics

Based in Irvine, Calif., Axonics is a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction. The company’s rechargeable sacr