Axonics® Announces First Quarter 2019 Financial Results and Operational Update
Recent Business Highlights
Net sales of the Axonics r-SNM® System1 from
international markets totaled
$1.1 millionin 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
Europewere focused in Englandand the Netherlands, gaining an estimated 25% of the SNM market in Englandand approximately 30% in the Netherlandsof 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 5the 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
Europemaking 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 FDAseeking approval for expansion of the market labeling to include the clinical indication of fecal incontinence (“FI”).
FDApre-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.
Michael H. Carrel, Jane E. Kiernanand 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
Cohen continued, “On the regulatory front, we are engaged in regular and
productive interactions with the
First Quarter 2019 Financial Results
Net revenue was
Gross margin was 49.2% in the first quarter of 2019.
Operating expense was
Net loss for the first quarter of 2019 was
Webcast and Conference Call
Axonics, based in
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
|Axonics Modulation Technologies, Inc.|
|Condensed Consolidated Balance Sheets|
|(in thousands, except share and per share data)|
|March 31,||December 31,|
|Cash and cash equivalents||$||89,334||$||98,306|
|Prepaid expenses and other current assets||2,778||3,716|
|Total current assets||152,799||165,340|
|Property and equipment, net||2,887||2,784|
|Intangible asset, net||397||426|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Lease liability, current portion||523||768|
|Debt, net of unamortized debt issuance costs, current portion||1,705||—|
|Total current liabilities||6,694||5,887|
|Lease liability, net of current portion||3,476||3,281|
|Debt, net of unamortized debt issuance costs, net of current portion||17,923||19,463|
|Preferred stock, par value $0.0001 per share; 10,000,000 shares authorized, no shares issued and outstanding at March 31, 2019 and December 31, 2018||—||—|
|Common stock, par value $0.0001, 50,000,000 shares authorized at March 31, 2019 and December 31, 2018; 28,201,091 and 27,806,934 shares issued and outstanding at March 31, 2019 and December 31, 2018, respectively||3||3|
|Additional paid-in capital||244,523||243,337|
|Accumulated other comprehensive loss||(426||)||(416||)|
|Total stockholders’ equity||131,334||143,275|
|Total liabilities and stockholders’ equity||$||159,427||$||171,906|
Axonics Modulation Technologies, Inc.
Condensed Consolidated Statements of Comprehensive Loss
(in thousands, except share and per share data)
|Three Months Ended
|Cost of goods sold||548||—|
|Research and development||4,219||4,543|
|General and administrative||4,015||1,435|
|Sales and marketing||5,914||548|
|Total operating expenses||14,148||6,526|
|Loss from operations||(13,619||)||(6,526||)|
|Other Income (Expense)|
|Interest and other expense||(532||)||(149||)|
|Other income (expense), net||502||(78||)|
|Loss before income tax expense||(13,117||)||(6,604||)|
|Income tax expense||—||—|
|Foreign currency translation adjustment||(10||)||(1||)|
|Net loss per share, basic and diluted||$||(0.47||)||$||(2.36||)|
Weighted-average shares used to compute basic and diluted net loss per share
Axonics Modulation Technologies, Inc.
Dan Dearen, +1-949-396-6320
President & Chief Financial Officer
Investor & Media Contact
Matt Clawson, +1-949-370-8500