• 4 March 2020
    Axonics® Announces Fourth Quarter and Fiscal 2019 Financial Results

    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, reported today financial results for the fourth quarter and year ended December 31, 2019 and provided an update on operational initiatives.

    Recent Business & Financial Highlights

    • In the fourth quarter of 2019, net revenue of the Axonics r-SNM® System totaled $9.9 million. Net revenue was consistent with the Company’s pre-announcement from early January. Demand for the Axonics product in the United States was brisk during the initial launch period following U.S. Food & Drug Administration (“FDA”) approval on November 13, 2019 resulting in net revenue from the United States of $8.4 million, with net revenue from select European markets accounting for $1.5 million.
    • Approximately 200 hospitals and ambulatory surgery centers implanted the Axonics r-SNM System into patients in the months of November and December. A total of 35 hospitals in England, the Netherlands, Switzerland, Germany and Canada implanted the Axonics r-SNM System in 2019.
    • In November 2019, Axonics raised approximately $118 million of gross proceeds in an underwritten public follow-on offering.
    • In December 2019, Axonics gained Health Canada approval for the use of 1.5T and 3T full body MRI scanners for patients implanted with the Axonics r-SNM System.
    • In January 2020, the FDA approved an enhanced, second-generation Programmer for the Axonics r-SNM System under a premarket approval application supplement. The new Programmer is used to program the Axonics external trial neurostimulator as well as the implantable neurostimulator in both the procedure and post-operative environments.
    • In February 2020, the German Institute for the Hospital Remuneration System granted reimbursement approval to the Axonics r-SNM System under a New Examination and Treatment Method (“NUB”) allowing hospitals to apply to the German government for additional funding.
    • In February 2020, Axonics executed its first post-FDA commercial exhibition at a major medical congress, participating in the Society for Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU) meeting in Scottsdale, AZ, attended by approximately 650 physicians. At the conference, the one-year results from the Company’s ARTISAN-SNM pivotal study were presented, demonstrating 89% efficacy and significant improvements in patient quality of life.

    Raymond W. Cohen, CEO of Axonics, commented, “The initial results of our U.S. launch clearly exceeded our expectations. These results were achieved based not only on the quality of our product and the demand from SNM implanters for a long-lived innovative product, but also can be attributed to the investment of time and capital we made to recruit, hire and train over 145 U.S. sales and clinical specialists during 2019 in advance of FDA approval.”

    Cohen continued, “The velocity of sales in the U.S. has continued in Q1 of 2020 with over 300 U.S. institutions now implanting our r-SNM System nationwide in the first quarter. Physician feedback has been very positive regarding patient outcomes and the support they are receiving from the Axonics team. We expect our momentum to continue throughout 2020 as more institutions begin implanting our device. We fully expect the U.S. market for SNM to increase based on the notion that more patients are choosing SNM given the attractive proposition of a 15+ year implant that does not require explant in the event that an MRI scan is needed.”

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