Axonics® Announces Fourth Quarter and Fiscal 2019 Financial Results
Recent Business & Financial Highlights
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In the fourth quarter of 2019, net revenue of the Axonics r-SNM® System totaled
$9.9 million . Net revenue was consistent with the Company’s pre-announcement from early January. Demand for the Axonics product inthe United States was brisk during the initial launch period followingU.S. Food & Drug Administration (“FDA”) approval onNovember 13, 2019 resulting in net revenue fromthe United States of$8.4 million , with net revenue from select European markets accounting for$1.5 million .
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Approximately 200 hospitals and ambulatory surgery centers implanted the Axonics r-SNM System into patients in the months of November and December. A total of 35 hospitals in
England ,the Netherlands ,Switzerland ,Germany andCanada implanted the Axonics r-SNM System in 2019.
-
In
November 2019 , Axonics raised approximately$118 million of gross proceeds in an underwritten public follow-on offering.
-
In
December 2019 , Axonics gainedHealth Canada approval for the use of 1.5T and 3T full body MRI scanners for patients implanted with the Axonics r-SNM System.
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In
January 2020 , the FDA approved an enhanced, second-generation Programmer for the Axonics r-SNM System under a premarket approval application supplement. The new Programmer is used to program the Axonics external trial neurostimulator as well as the implantable neurostimulator in both the procedure and post-operative environments.
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In
February 2020 , theGerman Institute for the Hospital Remuneration System granted reimbursement approval to the Axonics r-SNM System under a New Examination and Treatment Method (“NUB”) allowing hospitals to apply to the German government for additional funding.
-
In
February 2020 , Axonics executed its first post-FDA commercial exhibition at a major medical congress, participating in theSociety for Urodynamics , Female Pelvic Medicine and Urogenital Reconstruction (SUFU) meeting inScottsdale, AZ , attended by approximately 650 physicians. At the conference, the one-year results from the Company’s ARTISAN-SNM pivotal study were presented, demonstrating 89% efficacy and significant improvements in patient quality of life.
Cohen continued, “The velocity of sales in the
Fourth Quarter 2019 Financial Results
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Net revenue was
$9.9 million in the fourth quarter endedDecember 31, 2019 , as compared to net revenue of$0.5 million for the same period of the prior year.
-
Net revenue from
the United States accounted for$8.4 million , with net revenue from certain select European markets accounting for$1.5 million .
- Gross margin was 54.4%.
-
Operating expense was
$28.1 million for the fourth quarter of 2019, as compared to$9.7 million for the same period of the prior year. This increase was primarily due to higher personnel costs for theU.S. commercial team and across the organization related to increased headcount to support the commercial launch of the Company’s r-SNM System in theU.S.
-
Net loss for the fourth quarter of 2019 was
$22.8 million , as compared to$9.7 million for the same period of the prior year. Net loss per share was$0.75 per share.
-
As of
December 31, 2019 , cash, cash equivalents and short-term investments were$183.7 million as compared to$157.5 million atDecember 31, 2018 .
2019 Fiscal Year Financial Results
-
Net revenue was
$13.8 million in fiscal year 2019 and was derived from the sale of the Company’s r-SNM System to customers in theU.S. ,Europe andCanada . This compares to net revenue of$0.7 million in fiscal year 2018, which was derived from sales to customers inEurope andCanada .
- Gross margin was 53.0% in fiscal year 2019, compared to 49.7% gross margin in fiscal year 2018. The increase in gross margin is primarily due to country and product mix.
-
Operating expense was
$87.9 million for 2019, as compared to$32.5 million in fiscal year 2018. This increase was primarily due to higher personnel costs across the organization related to increased headcount to support the commercial launch of the Company’s r-SNM System in theU.S.
Webcast and Conference Call
Today, on
Interested parties may access the live call via telephone 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.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
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Consolidated Balance Sheets |
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(in thousands, except share and per share data) |
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2019 |
|
2018 |
|
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ASSETS |
|
|
|
||||||
Current assets |
|
|
|
||||||
Cash and cash equivalents |
$ |
171,082 |
|
|
$ |
98,306 |
|
||
Short-term investments |
12,592 |
|
|
59,218 |
|
||||
Accounts receivable, net of allowance for doubtful accounts of |
7,879 |
|
|
427 |
|
||||
Inventory, net |
15,659 |
|
|
3,673 |
|
||||
Prepaid expenses and other current assets |
4,468 |
|
|
3,716 |
|
||||
Total current assets |
211,680 |
|
|
165,340 |
|
||||
Property and equipment, net |
3,047 |
|
|
2,784 |
|
||||
Intangible asset, net |
311 |
|
|
426 |
|
||||
Other assets |
4,784 |
|
|
3,356 |
|
||||
Total assets |
$ |
219,822 |
|
|
$ |
171,906 |
|
||
|
|
|
|
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
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Current liabilities |
|
|
|
||||||
Accounts payable |
$ |
5,882 |
|
|
$ |
3,436 |
|
||
Accrued liabilities |
2,174 |
|
|
1,019 |
|
||||
Accrued compensation and benefits |
3,375 |
|
|
664 |
|
||||
Operating lease liability, current portion |
602 |
|
|
768 |
|
||||
Total current liabilities |
12,033 |
|
|
5,887 |
|
||||
Operating lease liability, net of current portion |
4,450 |
|
|
3,281 |
|
||||
Debt, net of unamortized debt issuance costs |
20,336 |
|
|
19,463 |
|
||||
Total liabilities |
36,819 |
|
|
28,631 |
|
||||
Stockholders’ Equity |
|
|
|
||||||
Preferred stock, par value |
— |
|
|
— |
|
||||
Common stock, par value |
3 |
|
|
3 |
|
||||
Additional paid-in capital |
363,012 |
|
|
243,337 |
|
||||
Accumulated deficit |
(179,584 |
) |
|
(99,649 |
) |
||||
Accumulated other comprehensive loss |
(428 |
) |
|
(416 |
) |
||||
Total stockholders’ equity |
183,003 |
|
|
143,275 |
|
||||
Total liabilities and stockholders’ equity |
$ |
219,822 |
|
|
$ |
171,906 |
|
||
|
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Consolidated Statements of Comprehensive Loss |
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(in thousands, except share and per share data) |
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Three Months Ended |
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Years Ended |
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|
2019 |
|
2018 |
|
2019 |
|
2018 |
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|
(unaudited) |
|
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(unaudited) |
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|
|
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|
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Net revenue |
$ |
9,946 |
|
|
$ |
494 |
|
|
$ |
13,820 |
|
|
$ |
707 |
|
Cost of goods sold |
4,538 |
|
|
245 |
|
|
6,490 |
|
|
356 |
|
||||
Gross profit |
5,408 |
|
|
249 |
|
|
7,330 |
|
|
351 |
|
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Operating Expenses |
|
|
|
|
|
|
|
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Research and development |
6,233 |
|
|
4,783 |
|
|
20,181 |
|
|
19,402 |
|
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General and administrative |
5,537 |
|
|
3,501 |
|
|
19,076 |
|
|
9,362 |
|
||||
Sales and marketing |
16,301 |
|
|
1,416 |
|
|
48,672 |
|
|
3,724 |
|
||||
Total operating expenses |
28,071 |
|
|
9,700 |
|
|
87,929 |
|
|
32,488 |
|
||||
Loss from operations |
(22,663 |
) |
|
(9,451 |
) |
|
(80,599 |
) |
|
(32,137 |
) |
||||
Other Income (Expense) |
|
|
|
|
|
|
|
||||||||
Interest income |
474 |
|
|
550 |
|
|
2,974 |
|
|
998 |
|
||||
Interest and other expense |
(562 |
) |
|
(764 |
) |
|
(2,309 |
) |
|
(1,343 |
) |
||||
Other income (expense), net |
(88 |
) |
|
(214 |
) |
|
665 |
|
|
(345 |
) |
||||
Loss before income tax expense |
(22,751 |
) |
|
(9,665 |
) |
|
(79,934 |
) |
|
(32,482 |
) |
||||
Income tax expense |
— |
|
|
— |
|
|
1 |
|
|
1 |
|
||||
Net loss |
(22,751 |
) |
|
(9,665 |
) |
|
(79,935 |
) |
|
(32,483 |
) |
||||
Foreign currency translation adjustment |
153 |
|
|
(10 |
) |
|
(12 |
) |
|
(14 |
) |
||||
Comprehensive loss |
$ |
(22,598 |
) |
|
$ |
(9,675 |
) |
|
$ |
(79,947 |
) |
|
$ |
(32,497 |
) |
|
|
|
|
|
|
|
|
||||||||
Net loss per share, basic and diluted |
$ |
(0.75 |
) |
|
$ |
(0.50 |
) |
|
$ |
(2.80 |
) |
|
$ |
(4.64 |
) |
Weighted-average shares used to compute basic and diluted net loss per share |
30,374,223 |
|
|
19,402,008 |
|
|
28,567,302 |
|
|
6,997,777 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20200304005745/en/
Vice President, Investor Relations
949-336-5293
ir@axonics.com
Source: