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.

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 sacral neuromodulation (SNM) system provides patients suffering from overactive bladder and/or fecal incontinence with long-lived, easy to use, safe, clinically effective therapy. In addition, Axonics’ best-in-class urethral bulking agent, Bulkamid^®, provides women suffering from stress urinary incontinence (SUI) with safe and durable symptom relief.

Overactive bladder affects an estimated 87 million adults in the U.S. and Europe, with an additional 40 million adults estimated to suffer from fecal incontinence. SUI affects an estimated 20 million women in the U.S. alone. Axonics’ clinically proven products are offered at hundreds of medical centers across the U.S. and abroad. Reimbursement coverage is well established in the U.S. and is a covered service in most European countries. For more information, visit www.axonics.com.

Forward-Looking Statements

Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Words such as “planned,” “expects,” “believes,” “anticipates,” “designed,” and similar words are intended to identify forward-looking statements. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, 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. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, Axonics undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.

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