Axonics® Announces Third Quarter 2019 Financial Results and Operational Update
Recent Business Highlights
-
Net sales of the Axonics r-SNM® System from international markets totaled
$1.3 million in the third quarter of 2019 as compared to$0.2 million in revenue in the same period last year. -
Sales in the third quarter were derived primarily from
England andthe Netherlands along with three hospitals inGermany and three hospitals inSwitzerland ordering in the quarter. A total of 32 hospitals in these markets and one inCanada are now implanting the Axonics r-SNM System. -
The first commercial patient was implanted in
the United States at theUniversity of California, Irvine onOctober 29 followed by a few dozen implants primarily for patients with bowel or dual incontinence in the first weeks following the commencement of sales in the U.S. -
During October and November, physician seminars were completed in
Orlando ,Irvine ,Dallas andBoston . These one-day Saturday seminars were attended by 273 U.S.-based SNM implanters. A fifth program has been added in early December to accommodate demand with 46 additional physicians currently registered. -
On
November 13 , theU.S. Food and Drug Administration (“FDA”) approved the Axonics r-SNM® System for the clinical indication of overactive bladder (“OAB”) which includes urinary urge incontinence and urinary urge frequency as well as urinary retention.
Cohen continued, “Given the attendance at our physician seminar series and enthusiastic response by the SNM implanting community to our product, we have made excellent strides towards establishing Axonics as a serious contender in sacral neuromodulation by bringing innovation and awareness to a therapy that has been underutilized. With respect to
Third Quarter 2019 Financial Results
-
Net revenue was
$1.3 million in the third quarter endedSeptember 30, 2019 as compared to net revenue of$0.2 million for the same period of last year. - Gross margin was 51.7%.
-
Operating expense was
$25.7 million for the third quarter of 2019, as compared to$7.6 million in the prior-year quarter. This increase was primarily due to higher personnel costs for the U.S. commercial team and across the organization related to increased headcount to support the commercial launch of the Company’s r-SNM System in the U.S. -
Net loss for the third quarter of 2019 was
$25.0 million , as compared to$7.6 million in the prior-year quarter. Net loss per share was$0.89 per share. -
As of
September 30, 2019 , cash, cash equivalents and short-term investments were$101.5 million .
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 4373989.
A live webcast of the call may be accessed by visiting the Events & Presentations page of the Investor Relations section of the Company’s website at ir.axonics.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. |
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Condensed Consolidated Balance Sheets |
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(in thousands, except share and per share data) |
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|
September 30, |
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December 31, |
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|
2019 |
|
2018 |
||||
|
(unaudited) |
|
|
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ASSETS |
|
|
|
||||
Current assets |
|
|
|
||||
Cash and cash equivalents |
$ |
76,231 |
|
|
$ |
98,306 |
|
Short-term investments |
25,311 |
|
|
59,218 |
|
||
Accounts receivable |
954 |
|
|
427 |
|
||
Inventory, net |
12,703 |
|
|
3,673 |
|
||
Prepaid expenses and other current assets |
2,625 |
|
|
3,716 |
|
||
Total current assets |
117,824 |
|
|
165,340 |
|
||
Property and equipment, net |
2,952 |
|
|
2,784 |
|
||
Intangible asset, net |
340 |
|
|
426 |
|
||
Other assets |
4,928 |
|
|
3,356 |
|
||
Total assets |
$ |
126,044 |
|
|
$ |
171,906 |
|
|
|
|
|
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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|
|
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Current liabilities |
|
|
|
||||
Accounts payable |
$ |
4,232 |
|
|
$ |
3,436 |
|
Accrued liabilities |
4,304 |
|
|
1,683 |
|
||
Lease liability, current portion |
625 |
|
|
768 |
|
||
Debt, net of unamortized debt issuance costs, current portion |
6,382 |
|
|
— |
|
||
Total current liabilities |
15,543 |
|
|
5,887 |
|
||
Lease liability, net of current portion |
4,573 |
|
|
3,281 |
|
||
Debt, net of unamortized debt issuance costs, net of current portion |
13,740 |
|
|
19,463 |
|
||
Total liabilities |
33,856 |
|
|
28,631 |
|
||
Stockholders’ equity |
|
|
|
||||
Preferred stock, par value $0.0001 per share; 10,000,000 shares authorized, no shares issued and outstanding at September 30, 2019 and December 31, 2018 |
— |
|
|
— |
|
||
Common stock, par value $0.0001, 50,000,000 shares authorized at September 30, 2019 and December 31, 2018; 28,633,911 and 27,806,934 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively |
3 |
|
|
3 |
|
||
Additional paid-in capital |
249,599 |
|
|
243,337 |
|
||
Accumulated deficit |
(156,833 |
) |
|
(99,649 |
) |
||
Accumulated other comprehensive loss |
(581 |
) |
|
(416 |
) |
||
Total stockholders’ equity |
92,188 |
|
|
143,275 |
|
||
Total liabilities and stockholders’ equity |
$ |
126,044 |
|
$ |
171,906 |
|
|
Axonics Modulation Technologies, Inc. |
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Condensed Consolidated Statements of Comprehensive Loss |
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(in thousands, except share and per share data) |
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(unaudited) |
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Three Months Ended
|
|
Nine Months Ended
|
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|
2019 |
|
2018 |
|
2019 |
|
2018 |
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Net revenue |
$ |
1,309 |
|
|
$ |
201 |
|
|
$ |
3,874 |
|
|
$ |
213 |
|
Cost of goods sold |
632 |
|
|
106 |
|
|
1,952 |
|
|
111 |
|
||||
Gross profit |
677 |
|
|
95 |
|
|
1,922 |
|
|
102 |
|
||||
Operating Expenses |
|
|
|
|
|
|
|
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Research and development |
4,855 |
|
|
3,898 |
|
|
13,948 |
|
|
14,619 |
|
||||
General and administrative |
5,162 |
|
|
2,790 |
|
|
13,539 |
|
|
5,861 |
|
||||
Sales and marketing |
15,707 |
|
|
949 |
|
|
32,371 |
|
|
2,308 |
|
||||
Total operating expenses |
25,724 |
|
|
7,637 |
|
|
59,858 |
|
|
22,788 |
|
||||
Loss from operations |
(25,047 |
) |
|
(7,542 |
) |
|
(57,936 |
) |
|
(22,686 |
) |
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Other Income (Expense) |
|
|
|
|
|
|
|
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Interest income |
627 |
|
|
172 |
|
|
2,500 |
|
|
448 |
|
||||
Interest and other expense |
(586 |
) |
|
(196 |
) |
|
(1,747 |
) |
|
(579 |
) |
||||
Other income (expense), net |
41 |
|
|
(24 |
) |
|
753 |
|
|
(131 |
) |
||||
Loss before income tax expense |
(25,006 |
) |
|
(7,566 |
) |
|
(57,183 |
) |
|
(22,817 |
) |
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Income tax expense |
— |
|
|
— |
|
|
1 |
|
|
1 |
|
||||
Net loss |
(25,006 |
) |
|
(7,566 |
) |
|
(57,184 |
) |
|
(22,818 |
) |
||||
Foreign currency translation adjustment |
(112 |
) |
|
(1 |
) |
|
(165 |
) |
|
(4 |
) |
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Comprehensive loss |
$ |
(25,118 |
) |
|
$ |
(7,567 |
) |
|
$ |
(57,349 |
) |
|
$ |
(22,822 |
) |
|
|
|
|
|
|
|
|
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Net loss per share, basic and diluted |
$ |
(0.89 |
) |
|
$ |
(2.67 |
) |
|
$ |
(2.05 |
) |
|
$ |
(8.10 |
) |
Weighted-average shares used to compute basic and diluted net loss per share |
28,098,564 |
|
|
2,830,591 |
|
|
27,958,376 |
|
|
2,817,652 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20191114005780/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