Axonics® Announces Second Quarter 2019 Financial Results and Operational Update
Recent Business Highlights
-
Net sales of the Axonics r-SNM® System1 from international markets totaled
$1.5 million in the second quarter of 2019 a sequential increase of$0.4 million in sales or approximately 38% from the 2019 first quarter. This compares to$12 thousand in revenue in the same period last year.
- Hiring and training of the U.S. commercial team is complete, now numbering 146 individuals, including 100 sales professionals, 11 regional sales managers and 35 clinical specialists.
-
Commercial efforts in
Europe were focused inEngland ,the Netherlands andGermany , gaining an estimated 30% of the market for new patient SNM implants inEngland in the second quarter of 2019. A total of 25 hospitals in these markets are now implanting the Axonics r-SNM System.
-
European commercial team expanded by three clinical specialists to support cases in
England andthe Netherlands and one sales representative inSwitzerland .
-
ARTISAN-SNM pivotal clinical study results were published in the
Journal of Urology . The results provide the highest response rate for SNM therapy published in clinical literature to date.
The U.S. Food and Drug Administration (“FDA”) approved full-body magnetic resonance imaging (“MRI”) scans for ARTISAN-SNM study patients in the U.S.
- Announced top-line results from one-year follow-up on patients in the ARTISAN-SNM pivotal clinical study. At one year, 89% of implanted subjects were therapy responders, consistent with the 90% therapy responder rate reported at six months. These data demonstrate durable, statistically significant improvements in urinary urgency incontinence symptoms and quality of life.
____________________ | |
1 |
The Axonics r-SNM System is currently under PMA review and designated as an investigational medical device in the United States |
Cohen continued, “With respect to
Second Quarter 2019 Financial Results
Net revenue was
Gross margin was 48.1% in the second quarter.
Operating expense was
Net loss for the second quarter of 2019 was
As of
Webcast and Conference Call
Today, on
Interested parties may access the live call via telephone by dialing (866) 687-5771 (U.S.) or (409) 217-8725 (International) and using conference ID 6687965.
A live webcast of the call may be accessed by visiting the Events & Presentations page of the investors section of the Company’s website at ir.axonicsmodulation.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Company’s website for 90 days.
About
Axonics, based in
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
Axonics Modulation Technologies, Inc. Condensed Consolidated Balance Sheets (in thousands, except share and per share data) |
|||||||
|
June 30, |
|
December 31, |
||||
|
2019 |
|
2018 |
||||
|
(unaudited) |
|
|
||||
ASSETS |
|
|
|
||||
Current assets |
|
|
|
||||
Cash and cash equivalents |
$ |
82,680 |
|
|
$ |
98,306 |
|
Short-term investments |
43,001 |
|
|
59,218 |
|
||
Accounts receivable |
1,286 |
|
|
427 |
|
||
Inventory |
7,975 |
|
|
3,673 |
|
||
Prepaid expenses and other current assets |
3,074 |
|
|
3,716 |
|
||
Total current assets |
138,016 |
|
|
165,340 |
|
||
Property and equipment, net |
3,000 |
|
|
2,784 |
|
||
Intangible asset, net |
368 |
|
|
426 |
|
||
Other assets |
5,068 |
|
|
3,356 |
|
||
Total assets |
$ |
146,452 |
|
|
$ |
171,906 |
|
|
|
|
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
||||
Current liabilities |
|
|
|
||||
Accounts payable |
$ |
3,185 |
|
|
$ |
3,436 |
|
Accrued liabilities |
3,630 |
|
|
1,683 |
|
||
Lease liability, current portion |
588 |
|
|
768 |
|
||
Debt, net of unamortized debt issuance costs, current portion |
3,897 |
|
|
— |
|
||
Total current liabilities |
11,300 |
|
|
5,887 |
|
||
Lease liability, net of current portion |
4,739 |
|
|
3,281 |
|
||
Debt, net of unamortized debt issuance costs, net of current portion |
16,000 |
|
|
19,463 |
|
||
Total liabilities |
32,039 |
|
|
28,631 |
|
||
Stockholders’ equity |
|
|
|
||||
Preferred stock, par value $0.0001 per share; 10,000,000 shares authorized, no shares issued and outstanding at June 30, 2019 and December 31, 2018 |
— |
|
|
— |
|
||
Common stock, par value $0.0001, 50,000,000 shares authorized at June 30, 2019 and December 31, 2018; 28,480,743 and 27,806,934 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively |
3 |
|
|
3 |
|
||
Additional paid-in capital |
246,706 |
|
|
243,337 |
|
||
Accumulated deficit |
(131,827 |
) |
|
(99,649 |
) |
||
Accumulated other comprehensive loss |
(469 |
) |
|
(416 |
) |
||
Total stockholders’ equity |
114,413 |
|
|
143,275 |
|
||
Total liabilities and stockholders’ equity |
$ |
146,452 |
$ |
171,906 |
Axonics Modulation Technologies, Inc. Condensed Consolidated Statements of Comprehensive Loss (in thousands, except share and per share data) (unaudited) |
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|
Three Months Ended
|
|
Six Months Ended
|
||||||||||||
|
2019 |
|
2018 |
|
2019 |
|
2018 |
||||||||
Net revenue |
$ |
1,488 |
|
|
$ |
12 |
|
|
$ |
2,565 |
|
|
$ |
12 |
|
Cost of goods sold |
772 |
|
|
5 |
|
|
1,320 |
|
|
5 |
|
||||
Gross profit |
716 |
|
|
7 |
|
|
1,245 |
|
|
7 |
|
||||
Operating Expenses |
|
|
|
|
|
|
|
||||||||
Research and development |
4,874 |
|
|
6,178 |
|
|
9,093 |
|
|
10,721 |
|
||||
General and administrative |
4,362 |
|
|
1,636 |
|
|
8,377 |
|
|
3,071 |
|
||||
Sales and marketing |
10,750 |
|
|
811 |
|
|
16,664 |
|
|
1,359 |
|
||||
Total operating expenses |
19,986 |
|
|
8,625 |
|
|
34,134 |
|
|
15,151 |
|
||||
Loss from operations |
(19,270 |
) |
|
(8,618 |
) |
|
(32,889 |
) |
|
(15,144 |
) |
||||
Other Income (Expense) |
|
|
|
|
|
|
|
||||||||
Interest income |
839 |
|
|
205 |
|
|
1,873 |
|
|
276 |
|
||||
Interest and other expense |
(629 |
) |
|
(234 |
) |
|
(1,161 |
) |
|
(383 |
) |
||||
Other income (expense), net |
210 |
|
|
(29 |
) |
|
712 |
|
|
(107 |
) |
||||
Loss before income tax expense |
(19,060 |
) |
|
(8,647 |
) |
|
(32,177 |
) |
|
(15,251 |
) |
||||
Income tax expense |
1 |
|
|
1 |
|
|
1 |
|
|
1 |
|
||||
Net loss |
(19,061 |
) |
|
(8,648 |
) |
|
(32,178 |
) |
|
(15,252 |
) |
||||
Foreign currency translation adjustment |
(43 |
) |
|
(2 |
) |
|
(53 |
) |
|
(3 |
) |
||||
Comprehensive loss |
$ |
(19,104 |
) |
|
$ |
(8,650 |
) |
|
$ |
(32,231 |
) |
|
$ |
(15,255 |
) |
|
|
|
|
|
|
|
|
||||||||
Net loss per share, basic and diluted |
$ |
(0.68 |
) |
|
$ |
(3.07 |
) |
|
$ |
(1.15 |
) |
|
$ |
(5.43 |
) |
Weighted-average shares used to compute basic and diluted net loss per share |
|
27,945,393 |
|
|
|
2,819,270 |
|
|
|
27,887,121 |
|
|
|
2,811,183 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20190805005439/en/
Source:
Axonics’ Contact
Axonics Modulation Technologies, Inc.
Dan Dearen, +1-949-396-6320
President & Chief Financial Officer
ir@axonics.com
Investor & Media Contact
W2Opure
Matt Clawson, +1-949-370-8500
mclawson@w2ogroup.com