Axonics® Reports Third Quarter 2020 Results
Axonics generated net revenue of
Over 5,500 patients have been implanted with the Axonics r-SNM System since
Third Quarter 2020 Financial Results
-
Net revenue was
$35.2 million in the third quarter endedSeptember 30, 2020 , as compared to net revenue of$1.3 million for the same period of the prior year.-
U.S. net revenue accounted for$34.1 million , with select international markets accounting for$1.1 million of net revenue. -
Over 600 unique accounts (hospitals and ambulatory surgery centers) in
the United States have implanted patients with the Axonics r-SNM® System since commercial launch inNovember 2019 , including more than 115 new accounts that were added in the third quarter of 2020.
-
-
Net revenue through the first nine months of 2020 was
$76.8 million , as compared to$3.9 million for the same period of the prior year. - Gross margin was 61.9% in the third quarter 2020, as compared to 51.7% for the same period of the prior year.
-
Operating expenses were
$30.6 million in the third quarter 2020, as compared to$25.7 million for the same period of the prior year. This increase was primarily due to higher personnel costs for theU.S. commercial team and in other parts of the organization. -
Net loss was
$9.2 million in the third quarter 2020, as compared to a net loss of$25.0 million for the same period of the prior year. -
As of
September 30, 2020 , cash and cash equivalents were$269.3 million .
Clinical and Regulatory Highlights
-
On
July 1, 2020 , the Axonics r-SNM System received FDA approval for 3.0 Tesla full-body MRI scans. -
In
August 2020 , Axonics began shipping its second-generation implantable neurostimulator (INS) toU.S. customers. The new INS extends the recharge interval for patients to just once a month for one hour. -
On
September 8, 2020 , Axonics announced NICE's recommendation of the Axonics r-SNM System. -
On
September 10, 2020 , Axonics reported 2-year clinical results from its ARTISAN-SNM pivotal study. -
On
September 21, 2020 , Axonics announcedHealth Canada's approval of its second-generation INS. -
On
September 24, 2020 , Axonics announced that theU.S. Patent Trial and Appeal Board has instituted a review regarding the validity of six Medtronic patents that Axonics is contesting. -
On
October 5, 2020 , Axonics announced survey results of patients treated with the Axonics r-SNM System that were previously implanted with InterStim™ II.
Webcast and Conference Call
Axonics will host a conference call today,
A live webcast of the conference call may be accessed by visiting the Events & Presentations section of the Axonics investor relations 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 Axonics 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
Condensed Consolidated Balance Sheets (in thousands, except share and per share data) |
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2020 |
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2019 |
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(unaudited) |
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ASSETS |
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Current assets |
|
|
|
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Cash and cash equivalents |
$ |
269,280 |
|
|
$ |
171,082 |
|
Short-term investments |
— |
|
|
12,592 |
|
||
Accounts receivable, net of allowance for doubtful accounts of |
17,650 |
|
|
7,879 |
|
||
Inventory, net |
44,308 |
|
|
15,659 |
|
||
Prepaid expenses and other current assets |
3,220 |
|
|
4,468 |
|
||
Total current assets |
334,458 |
|
|
211,680 |
|
||
Property and equipment, net |
5,792 |
|
|
3,047 |
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||
Intangible asset, net |
225 |
|
|
311 |
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||
Other assets |
7,196 |
|
|
4,784 |
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Total assets |
$ |
347,671 |
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|
$ |
219,822 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities |
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Accounts payable |
$ |
9,415 |
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|
$ |
5,882 |
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Accrued liabilities |
5,977 |
|
|
2,174 |
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Accrued compensation and benefits |
7,516 |
|
|
3,375 |
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Operating lease liability, current portion |
908 |
|
|
602 |
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Debt, current portion |
15,000 |
|
|
— |
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Total current liabilities |
38,816 |
|
|
12,033 |
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Operating lease liability, net of current portion |
9,027 |
|
|
4,450 |
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||
Debt, net of unamortized debt issuance costs, net of current portion |
5,930 |
|
|
20,336 |
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Total liabilities |
53,773 |
|
|
36,819 |
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||
Stockholders’ equity |
|
|
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Preferred stock, par value |
— |
|
|
— |
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Common stock, par value |
4 |
|
|
3 |
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Additional paid-in capital |
517,659 |
|
|
363,012 |
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Accumulated deficit |
(223,151) |
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|
(179,584) |
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Accumulated other comprehensive loss |
(614) |
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|
(428) |
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Total stockholders’ equity |
293,898 |
|
|
183,003 |
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Total liabilities and stockholders’ equity |
$ |
347,671 |
|
|
$ |
219,822 |
|
Condensed Consolidated Statements of Comprehensive Loss (in thousands, except share and per share data) (unaudited) |
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Three Months Ended
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Nine Months Ended
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2020 |
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2019 |
|
2020 |
|
2019 |
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Net revenue |
$ |
35,243 |
|
|
$ |
1,309 |
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|
$ |
76,752 |
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|
$ |
3,874 |
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Cost of goods sold |
13,434 |
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|
632 |
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|
31,792 |
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|
1,952 |
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Gross profit |
21,809 |
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|
677 |
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|
44,960 |
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|
1,922 |
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Operating Expenses |
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Research and development |
7,748 |
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|
4,855 |
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|
21,030 |
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|
13,948 |
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General and administrative |
5,773 |
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|
5,162 |
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|
18,963 |
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|
13,539 |
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Sales and marketing |
17,057 |
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|
15,707 |
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|
47,846 |
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|
32,371 |
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Total operating expenses |
30,578 |
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|
25,724 |
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|
87,839 |
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|
59,858 |
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Loss from operations |
(8,769) |
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|
(25,047) |
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|
(42,879) |
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|
(57,936) |
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Other Income (Expense) |
|
|
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|
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Interest income |
35 |
|
|
627 |
|
|
742 |
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|
2,500 |
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Interest and other expense |
(434) |
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|
(586) |
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|
(1,429) |
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|
(1,747) |
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Other income (expense), net |
(399) |
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|
41 |
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|
(687) |
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|
753 |
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Loss before income tax expense |
(9,168) |
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|
(25,006) |
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|
(43,566) |
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|
(57,183) |
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Income tax expense |
— |
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— |
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|
1 |
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|
1 |
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Net loss |
(9,168) |
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|
(25,006) |
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|
(43,567) |
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|
(57,184) |
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Foreign currency translation adjustment |
99 |
|
|
(112) |
|
|
(186) |
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|
(165) |
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Comprehensive loss |
$ |
(9,069) |
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|
$ |
(25,118) |
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$ |
(43,753) |
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$ |
(57,349) |
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Net loss per share, basic and diluted |
$ |
(0.24) |
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|
$ |
(0.89) |
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|
$ |
(1.20) |
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$ |
(2.05) |
|
Weighted-average shares used to compute basic and diluted net loss per share |
38,830,924 |
|
|
28,098,564 |
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|
36,312,984 |
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|
27,958,376 |
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View source version on businesswire.com: https://www.businesswire.com/news/home/20201104005132/en/
Axonics contact:
949-336-5293
IR@axonics.com
Source: