• 8 May 2019
    Axonics® Announces First Quarter 2019 Financial Results and Operational Update

    Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing a novel implantable Sacral Neuromodulation (“SNM”) device for the treatment of urinary and bowel dysfunction, reported today financial results for the first quarter ended March 31, 2019, and provided an update on operational initiatives.

    Recent Business Highlights

    • Net sales of the Axonics r-SNM® System1 from international markets totaled $1.1 million in the first quarter of 2019, sequentially doubling sales from the 2018 fourth quarter. This compares to no revenue in the same period last year.
    • Commercial efforts in Europe were focused in England and the Netherlands, gaining an estimated 25% of the SNM market in England and approximately 30% in the Netherlands of new patient implants in the first quarter of 2019. A total of 23 hospitals in these markets are now implanting the Axonics r-SNM System.
    • Presented at the American Urology Association (AUA) Annual Meeting on May 5 the ARTISAN-SNM pivotal clinical study results on the full cohort of patients implanted with the Axonics r-SNM System. The pivotal study results indicated 90% of all implanted subjects met the efficacy endpoint and that the study met all primary and secondary endpoints.
    • Achieved CE Mark approval for full-body magnetic resonance imaging (“MRI”) conditional labeling in Europe making the Axonics system the first SNM device to allow a full-body MRI scan without being first explanted.
    • Filed full-body MRI data with the U.S. Food and Drug Administration (“FDA”) seeking conditional labeling upon pre-market approval (“PMA”) for the Axonics r-SNM System.
    • Filed, during the first week of March 2019, a PMA with the FDA seeking approval for expansion of the market labeling to include the clinical indication of fecal incontinence (“FI”).
    • Completed an FDA pre-PMA audit and inspection of the Axonics quality system and its manufacturing processes and facility resulting in zero observations.
    • Was informed by the FDA, there will be no formal “90-day substantive review letter” issued to Axonics because there are no outstanding deficiencies.
    • Appointed Michael H. Carrel, Jane E. Kiernan and Nancy L. Snyderman, M.D. to the Board of Directors.

    1 The Axonics r-SNM System is currently designated as an investigational medical device in the United States

    Raymond W. Cohen, CEO of Axonics, commented, “The generation of $1.1 million of revenue in the first quarter shows strong progress and reflects the growing number of centers adopting our r-SNM product. We anticipate continued market share gains from our two primary markets in Europe in 2019, England and the Netherlands, and view those countries as models for engaging and earning market share in the United States upon FDA regulatory approval. While we are clear that the prize is the U.S. market which represents nearly 90 percent of the overall volume in SNM, based on this encouraging start, we do plan to expand our footprint in Europe during 2019 and into 2020. Achieving CE Mark for full-body MRI labeling, along with the unique features of our long-lived neurostimulator, has provided important differentiators as compared to the legacy provider, aiding our modestly-sized field team in gaining access to the most active implanting centers.”

    Cohen continued, “On the regulatory front, we are engaged in regular and productive interactions with the FDA with our primary focus on gaining approval in the shortest possible timeframe. We have enriched our current PMA with the full cohort of ARTISAN-SNM study data as well as the full-body MRI data. We believe that a significant portion of the FDA review is complete and are confident that FDA approval will come during the second half of 2019. While we push forward for clearance to market in the U.S., we continue to put all the operational, manufacturing and commercial pieces in place to support a broad, fully staffed and immediate U.S. launch upon approval. The internal and U.S. commercial teams continue to be rounded out. Overall, we are making excellent progress on our key operational objectives.”

    First Quarter 2019 Financial Results

    Net revenue was $1.1 million in the first quarter ended March 31, 2019, derived from the sale of the Company’s r-SNM Systems to customers in Europe and Canada, as compared to no net revenue for the same period of last year.

    Gross margin was 49.2% in the first quarter of 2019.

    Operating expense was $14.1 million for the first quarter of 2019, as compared to $6.5 million in the prior-year quarter. This increase was primarily due to higher personnel costs across the organization related to increased headcount in anticipation of the commercial launch of the Company’s r-SNM System in the U.S., as well as higher costs associated with operating as a public company.

    Net loss for the first quarter of 2019 was $13.1 million as compared to $6.6 million in the prior-year quarter. Net loss per share for the first quarter of 2019 was $0.47 per share.

    As of March 31, 2019, cash, cash equivalents and short-term investments were $144.2 million.