Axonics® Reports First Quarter 2021 Financial Results
“This quarter’s revenue result reflects growing demand for our long-lived r-SNM® system and Bulkamid® despite the resurgence of COVID cases in the
Cohen continued, “Response to our recent acquisition of Bulkamid has been overwhelmingly positive. As anticipated, the expanded offering has elevated Axonics’ value proposition to the urology and urogynecology community. Clinicians are enthusiastic to offer this safe and efficacious next-generation bulking agent to women suffering from stress urinary incontinence. Physicians working with
First Quarter 2021 Financial Results
-
Net revenue was
$34.4 million in the first quarter 2021, an increase of 31% compared to$26.3 million in the prior year period.-
Sacral neuromodulation revenue was
$32.9 million , of which$31.7 million was generated in theU.S. and the remainder in select international markets. -
Bulkamid revenue for March1 was
$1.5 million , of which$0.6 million was generated in theU.S. and the remainder in international markets.
-
Sacral neuromodulation revenue was
- Gross margin was 59.3% in the first quarter 2021 compared to 62.4% in the prior year period.
-
Operating expenses were
$42.0 million in the first quarter 2021 compared to$31.1 million in the prior year period. Excluding one-time acquisition-related costs and amortization of intangibles, operating expenses were$36.9 million . -
Net loss was
$22.5 million in the first quarter 2021 compared to a net loss of$14.6 million in the prior year period. -
As of
March 31, 2021 , cash and cash equivalents were$131.0 million .
_____________________ |
1 The acquisition of Bulkamid was completed on |
First Quarter 2021 Corporate Highlights
-
On
January 28, 2021 , a manuscript was published online in Neurourology and Urodynamics discussing the two-year outcomes of the ARTISAN-SNM study. -
On
February 16, 2021 ,Axonics announced FDA approval of its third-generation implantable neurostimulator. -
On
March 2, 2021 ,Axonics announced a strategic alliance for the manufacture of its new non-rechargeable implantable sacral neuromodulation device.
Fiscal Year 2021 Financial Outlook
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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
Condensed Consolidated Statements of Comprehensive Loss (in thousands, except share and per share data) (unaudited) |
|||||||
|
Three Months Ended
|
||||||
|
2021 |
|
2020 |
||||
Sacral neuromodulation net revenue |
$ |
32,903 |
|
|
$ |
26,296 |
|
Bulkamid net revenue |
1,470 |
|
|
— |
|
||
Total net revenue |
34,373 |
|
|
26,296 |
|
||
Cost of goods sold |
13,974 |
|
|
9,895 |
|
||
Gross profit |
20,399 |
|
|
16,401 |
|
||
Operating Expenses |
|
|
|
||||
Research and development |
9,369 |
|
|
6,855 |
|
||
General and administrative |
6,626 |
|
|
7,653 |
|
||
Sales and marketing |
20,928 |
|
|
16,569 |
|
||
Amortization of intangible assets |
678 |
|
|
29 |
|
||
Acquisition-related costs |
4,414 |
|
|
— |
|
||
Total operating expenses |
42,015 |
|
|
31,106 |
|
||
Loss from operations |
(21,616 |
) |
|
(14,705 |
) |
||
Other Income (Expense) |
|
|
|
||||
Interest income |
8 |
|
|
642 |
|
||
Interest and other expense |
(1,450 |
) |
|
(552 |
) |
||
Other (expense) income, net |
(1,442 |
) |
|
90 |
|
||
Loss before income tax expense |
(23,058 |
) |
|
(14,615 |
) |
||
Income tax (benefit) expense |
(555 |
) |
|
1 |
|
||
Net loss |
(22,503 |
) |
|
(14,616 |
) |
||
Foreign currency translation adjustment |
(2,202 |
) |
|
(177 |
) |
||
Comprehensive loss |
$ |
(24,705 |
) |
|
$ |
(14,793 |
) |
|
|
|
|
||||
Net loss per share, basic and diluted |
$ |
(0.57 |
) |
|
$ |
(0.43 |
) |
Weighted-average shares used to compute basic and diluted net loss per share |
39,613,964 |
|
|
33,637,646 |
|
Condensed Consolidated Balance Sheets (in thousands, except share and per share data) |
|||||||
|
|
|
|
||||
|
2021 |
|
2020 |
||||
|
(unaudited) |
|
|
||||
ASSETS |
|
|
|
||||
Current assets |
|
|
|
||||
Cash and cash equivalents |
$ |
130,962 |
|
|
$ |
241,181 |
|
Accounts receivable, net of allowance for doubtful accounts of |
21,509 |
|
|
18,270 |
|
||
Inventory, net |
71,243 |
|
|
63,060 |
|
||
Prepaid expenses and other current assets |
4,658 |
|
|
5,435 |
|
||
Total current assets |
228,372 |
|
|
327,946 |
|
||
Property and equipment, net |
6,048 |
|
|
6,328 |
|
||
Intangible assets, net |
115,023 |
|
|
196 |
|
||
Other assets |
8,145 |
|
|
7,736 |
|
||
|
87,382 |
|
|
— |
|
||
Total assets |
$ |
444,970 |
|
|
$ |
342,206 |
|
|
|
|
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
||||
Current liabilities |
|
|
|
||||
Accounts payable |
$ |
11,446 |
|
|
$ |
10,660 |
|
Accrued liabilities |
5,868 |
|
|
6,684 |
|
||
Accrued compensation and benefits |
5,348 |
|
|
5,948 |
|
||
Operating lease liability, current portion |
1,362 |
|
|
1,280 |
|
||
Debt, net of unamortized debt issuance costs, current portion |
22 |
|
|
21,110 |
|
||
Total current liabilities |
24,046 |
|
|
45,682 |
|
||
Operating lease liability, net of current portion |
8,849 |
|
|
9,154 |
|
||
Debt, net of unamortized debt issuance costs, net of current portion |
75,171 |
|
|
— |
|
||
Other long-term liabilities |
6,750 |
|
|
— |
|
||
Total liabilities |
114,816 |
|
|
54,836 |
|
||
Stockholders’ equity |
|
|
|
||||
Preferred stock, par value |
— |
|
|
— |
|
||
Common stock, par value |
4 |
|
|
4 |
|
||
Additional paid-in capital |
589,785 |
|
|
522,296 |
|
||
Accumulated deficit |
(257,002 |
) |
|
(234,499 |
) |
||
Accumulated other comprehensive loss |
(2,633 |
) |
|
(431 |
) |
||
Total stockholders’ equity |
330,154 |
|
|
287,370 |
|
||
Total liabilities and stockholders’ equity |
$ |
444,970 |
|
|
$ |
342,206 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20210506006068/en/
949-336-5293
ir@axonics.com
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