Axonics, Inc. - AXNX STOCK NEWS

Axonics, Inc. (NASDAQ: AXNX) has submitted a premarket approval supplement to the FDA for its fourth-generation rechargeable sacral neuromodulation implantable neurostimulator (INS). This new device reduces recharging frequency to once every six months, compared to the monthly requirement of the previous version. Axonics anticipates FDA approval in Q4 2022 and aims for product shipments to begin in Q1 2023. The company recently gained FDA approval for its recharge-free system, enhancing market potential in bladder and bowel dysfunction treatments.

Axonics, Inc. (Nasdaq: AXNX) reported Q1 2022 financial results, showing net revenue of $48.4 million, a 41% increase from Q1 2021. Sacral neuromodulation revenue reached $39.1 million, while Bulkamid revenue was $9.4 million, marking a 72% increase year-over-year. Despite a net loss of $22.7 million, cash reserves stood at $213.2 million. The company updated its fiscal year 2022 revenue guidance to $238 million, up 32% from 2021. The launch of the Axonics F15™ and a new advertising campaign are expected to boost market presence.

Axonics, a medical technology company, will present at the BofA Securities 2022 Healthcare Conference on May 10, 2022, at 12:20 p.m. ET. The presentation will be available via live webcast and on their investor relations website. Based in Irvine, California, Axonics specializes in innovative solutions for bladder and bowel dysfunction, including sacral neuromodulation systems and Bulkamid® for urinary incontinence. The company ranks No. 1 on Deloitte's 2021 Technology Fast 500 and among the top 500 fastest-growing companies by the Financial Times.

Axonics, Inc. has launched the Axonics F15, a recharge-free sacral neuromodulation (SNM) system, across the United States. This device, which received FDA approval in March, boasts a longevity of over 15 years at typical settings and potential for more than 20 years at lower energy. The F15 is 20% smaller than competitors and features constant current stimulation. Physician responses have been positive, indicating strong clinical outcomes. The launch aims to address the needs of millions suffering from bladder and bowel dysfunction, supported by established reimbursement coverage.

Axonics, Inc. (NASDAQ: AXNX) will release its first quarter 2022 financial results on May 5, 2022, after market close. A conference call will follow at 4:30 p.m. ET, accessible via phone or webcast. The company specializes in medical technology for bladder and bowel dysfunction, recently earning recognition on the 2021 Deloitte Technology Fast 500™ and 2022 Financial Times rankings. Axonics offers sacral neuromodulation systems and Bulkamid® for urinary incontinence, addressing conditions affecting millions in the U.S. and Europe.

Axonics, Inc. (NASDAQ: AXNX) has launched a direct-to-consumer television advertising campaign titled Find Real Relief, targeting women with urinary incontinence. The initiative aims to raise awareness of incontinence, reduce the stigma, and promote consulting bladder specialists. Ads are airing in 40 U.S. markets and include a new patient landing page, FindRealRelief.com, which connects patients to healthcare providers. The campaign is expected to drive market expansion for Axonics' sacral neuromodulation therapy.

Axonics has achieved FDA approval for its recharge-free sacral neuromodulation (SNM) implantable neurostimulator, the Axonics F15. This device boasts a functional life exceeding 15 years at standard stimulation parameters and 20 years at lower settings. It is 20% smaller than competitors, features full-body MRI compatibility, and an intuitive patient remote control. The company plans to launch a national advertising campaign to boost awareness for SNM therapy, which addresses incontinence affecting millions of Americans. The shipping is set to commence in April.

Axonics, Inc. (Nasdaq: AXNX) reported a 53% increase in fourth-quarter revenue to $53.1 million year-over-year, driven by strong sales in sacral neuromodulation (SNM) and Bulkamid products. For fiscal year 2021, revenue reached $180.3 million, marking a 62% year-over-year growth. However, the company posted a net loss of $80.1 million for FY 2021, compared to $54.9 million in FY 2020. Looking ahead, Axonics projects 2022 revenue of $234 million, a 30% increase, with SNM and Bulkamid anticipated to grow by 25% and 63%, respectively.

Axonics, Inc. (NASDAQ: AXNX) will announce its fourth quarter and fiscal year 2021 financial results on February 24, 2022, after market close. A conference call to discuss these results will take place at 4:30 p.m. Eastern Time, accessible via call or webcast. Axonics, recognized as the fastest-growing medical technology company by Deloitte’s 2021 Technology Fast 500™, develops innovative treatments for bladder and bowel dysfunction. Their rechargeable sacral neuromodulation system effectively addresses overactive bladder and fecal incontinence, while Bulkamid offers durable relief for stress urinary incontinence.