Axonics® Reports First Quarter 2020 Results
Recent Business & Financial Highlights
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Net revenue was
$26.3 million in the first quarter of 2020, the first full quarter of commercial results followingU.S. Food & Drug Administration (“FDA”) approval of the Axonics r-SNM® System inNovember 2019 . Sales momentum accelerated throughout the first quarter, peaking in mid-March prior to COVID-19 related postponement of elective procedures. -
Over 350 unique accounts (hospitals and ambulatory surgery centers) in
the United States implanted patients with the Axonics r-SNM System in the first quarter of 2020. -
Over 110 facility agreements with national and regional IDNs as well as large urology groups and ambulatory surgery centers have been signed since the
U.S. launch. Included in this group are agreements with three of the largest national IDNs in theU.S. which were executed in March. Another 85 agreements are currently in process. -
In
January 2020 , the FDA approved an enhanced, second-generation programmer for the Axonics r-SNM System under a premarket approval (“PMA”) supplement. The new programmer features, among other things, a predictive programming algorithm that translates intra-operative responses and suggests how to program the patient for optimum therapy, thereby reducing the need to adjust post-implant therapy. -
In
April 2020 , Axonics submitted a PMA supplement to the FDA for the purpose of gaining full-body MRI conditional labeling for 3.0T MRI scans. Both 1.5T and 3.0T labeling is approved inEurope under the CE Mark. InSeptember 2019 , the FDA approved full-body labeling for 1.5T MR scanners. Axonics has since performed all the required tests to support the rationale for full-body 3.0T labeling. -
In
April 2020 , the FDA approved a next generation rechargeable implantable neurostimulator (“INS”) for the Axonics r-SNM System under a PMA supplement. The new INS decreases how frequently a patient needs to recharge their implanted device to once a month for about one hour and for some patients, once every other month. The next generation Axonics INS is expected to begin shipping toU.S. customers early in the third quarter of 2020.
First Quarter 2020 Financial Results
-
Net revenue was
$26.3 million in the first quarter 2020, as compared to net revenue of$1.1 million for the same period of the prior year. -
Net revenue from
the United States accounted for$25.0 million , with select European markets andCanada accounting for the balance of first quarter 2020 revenue. - Gross margin was 62.4% in the first quarter 2020, as compared to 49.2% for the same period of the prior year.
-
Operating expenses were
$31.1 million in the first quarter 2020, as compared to$14.1 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
$14.6 million in the first quarter 2020, as compared to$13.1 million for the same period of the prior year. -
As of
March 31, 2020 , cash, cash equivalents and short-term investments were$159.8 million , as compared to$183.7 million atDecember 31, 2019 .
Webcast and Conference Call
Axonics will host a conference call with the investment community today,
Interested parties may access the live teleconference by dialing 866-687-5771 (
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.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
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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|
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ASSETS |
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|
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Current assets |
|
|
|
||||
Cash and cash equivalents |
$ |
159,820 |
|
|
$ |
171,082 |
|
Short-term investments |
— |
|
|
12,592 |
|
||
Accounts receivable, net of allowance for doubtful accounts of |
20,770 |
|
|
7,879 |
|
||
Inventory, net |
19,230 |
|
|
15,659 |
|
||
Prepaid expenses and other current assets |
4,245 |
|
|
4,468 |
|
||
Total current assets |
204,065 |
|
|
211,680 |
|
||
Property and equipment, net |
5,406 |
|
|
3,047 |
|
||
Intangible asset, net |
282 |
|
|
311 |
|
||
Other assets |
7,626 |
|
|
4,784 |
|
||
Total assets |
$ |
217,379 |
|
|
$ |
219,822 |
|
|
|
|
|
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities |
|
|
|
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Accounts payable |
$ |
7,440 |
|
|
$ |
5,882 |
|
Accrued liabilities |
3,110 |
|
|
2,174 |
|
||
Accrued compensation and benefits |
3,503 |
|
|
3,375 |
|
||
Operating lease liability, current portion |
794 |
|
|
602 |
|
||
Debt, current portion |
5,000 |
|
|
— |
|
||
Total current liabilities |
19,847 |
|
|
12,033 |
|
||
Operating lease liability, net of current portion |
9,485 |
|
|
4,450 |
|
||
Debt, net of unamortized debt issuance costs, net of current portion |
15,571 |
|
|
20,336 |
|
||
Total liabilities |
44,903 |
|
|
36,819 |
|
||
Stockholders’ equity |
|
|
|
||||
Preferred stock, par value |
— |
|
|
— |
|
||
Common stock, par value |
3 |
|
|
3 |
|
||
Additional paid-in capital |
367,278 |
|
|
363,012 |
|
||
Accumulated deficit |
(194,200 |
) |
|
(179,584 |
) |
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Accumulated other comprehensive loss |
(605 |
) |
|
(428 |
) |
||
Total stockholders’ equity |
172,476 |
|
|
183,003 |
|
||
Total liabilities and stockholders’ equity |
$ |
217,379 |
|
|
$ |
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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|
2020 |
|
2019 |
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Net revenue |
$ |
26,296 |
|
|
$ |
1,077 |
|
Cost of goods sold |
9,895 |
|
|
548 |
|
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Gross profit |
16,401 |
|
|
529 |
|
||
Operating Expenses |
|
|
|
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Research and development |
6,884 |
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|
4,219 |
|
||
General and administrative |
7,653 |
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|
4,015 |
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Sales and marketing |
16,569 |
|
|
5,914 |
|
||
Total operating expenses |
31,106 |
|
|
14,148 |
|
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Loss from operations |
(14,705 |
) |
|
(13,619 |
) |
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Other Income (Expense) |
|
|
|
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Interest income |
642 |
|
|
1,034 |
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Interest and other expense |
(552 |
) |
|
(532 |
) |
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Other income, net |
90 |
|
|
502 |
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Loss before income tax expense |
(14,615 |
) |
|
(13,117 |
) |
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Income tax expense |
1 |
|
|
— |
|
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Net loss |
(14,616 |
) |
|
(13,117 |
) |
||
Foreign currency translation adjustment |
(177 |
) |
|
(10 |
) |
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Comprehensive loss |
$ |
(14,793 |
) |
|
$ |
(13,127 |
) |
|
|
|
|
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Net loss per share, basic and diluted |
$ |
(0.43 |
) |
|
$ |
(0.47 |
) |
Weighted-average shares used to compute basic and diluted net loss per share |
33,637,646 |
|
|
27,828,201 |
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View source version on businesswire.com: https://www.businesswire.com/news/home/20200505005824/en/
Investor Relations
949-336-5293
ir@axonics.com
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