Axonics Reports Fourth Quarter and Fiscal Year 2022 Financial Results
Generated record quarterly revenue of
Reported fiscal year 2022 revenue of
Reiterated fiscal year 2023 revenue guidance of
“This quarter’s record results reflect the growing demand for our best-in-class incontinence products,” said
Cohen continued, “In addition to strong commercial execution, we are encouraged by the measurable operating leverage in our business which produced adjusted EBITDA of
Fourth Quarter 2022 Financial Results
-
Net revenue was
$85.9 million in fourth quarter 2022, an increase of 62% compared to the prior year period.-
Sacral neuromodulation revenue was
$70.3 million , of which$69.1 million was generated in theU.S. and the remainder in international markets. -
Bulkamid revenue was
$15.6 million , of which$12.3 million was generated in theU.S. and the remainder in international markets.
-
Sacral neuromodulation revenue was
- Gross margin was 73.3% in fourth quarter 2022 compared to 66.6% in the prior year period.
-
Operating expenses were
$66.6 million in fourth quarter 2022 and included a$2.1 million non-cash charge for the change in fair value of contingent consideration related to the Bulkamid acquisition. Operating expenses were$53.1 million in the prior year period.-
Excluding acquisition-related charges, adjusted operating expenses were
$64.5 million in fourth quarter 2022 and$51.6 million in the prior year period.
-
Excluding acquisition-related charges, adjusted operating expenses were
-
Adjusted EBITDA was
$10.1 million in fourth quarter 2022 compared to an adjusted EBITDA loss of$6.7 million in the prior year period. -
Net income was
$0.7 million in fourth quarter 2022 compared to a net loss of$15.2 million in the prior year period.-
Net income in fourth quarter 2022 benefited from
$3.8 million of interest and other income, net.
-
Net income in fourth quarter 2022 benefited from
-
Cash, cash equivalents and short-term investments were
$357 million as ofDecember 31, 2022 .
Fiscal Year 2022 Financial Results
-
Net revenue was
$273.7 million in fiscal year 2022, an increase of 52% compared to the prior year.-
SNM revenue was
$222.0 million , of which$216.9 million was generated in theU.S. and the remainder in international markets. -
Bulkamid revenue was
$51.7 million , of which$40.2 million was generated in theU.S. and the remainder in international markets.
-
SNM revenue was
- Gross margin was 72.2% in fiscal year 2022 compared to 64.2% in the prior year.
-
Operating expenses were
$262.6 million in fiscal year 2022 and included$22.6 million of non-cash charges for the change in fair value of contingent consideration related to the Bulkamid acquisition. Operating expenses were$187.5 million in the prior year.-
Excluding acquisition-related charges, adjusted operating expenses were
$240.1 million in fiscal year 2022 and$180.4 million in the prior year.
-
Excluding acquisition-related charges, adjusted operating expenses were
-
Adjusted EBITDA was
$1.6 million in fiscal year 2022 compared to an adjusted EBITDA loss of$30.4 million in the prior year. -
Net loss was
$59.7 million in fiscal year 2022 compared to net loss of$80.1 million in the prior year.
Fiscal Year 2023 Revenue Guidance
-
Sacral neuromodulation revenue of
$277.5 million . -
Bulkamid revenue of
$64.5 million .
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About
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 “plans,” “expects,” “believes,” “anticipates,” “designs,” 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
Use of Non-GAAP Financial Measures
To supplement Axonics’ consolidated financial statements prepared in accordance with generally accepted accounting principles (GAAP),
Adjusted EBITDA is calculated as net income (loss) before other income/expense (including interest), income tax expense (benefit), depreciation and amortization expense, stock-based compensation expense, acquisition-related costs, loss on disposal of property and equipment, and expense related to impairment of intangible assets. Management believes that in order to properly understand short-term and long-term financial trends, investors may want to consider the impact of these excluded items in addition to GAAP measures. The excluded items vary in frequency and/or impact on our results of operations and management believes that the excluded items are typically not reflective of our ongoing core business operations and financial condition. Further, management uses adjusted EBITDA for both strategic and annual operating planning. A reconciliation of adjusted EBITDA reported in this release to the most comparable GAAP measure for the respective periods appears in the table captioned “Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA” later in this release.
The non-GAAP financial measures used by
Consolidated Balance Sheets (in thousands, except share and per share data) |
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2022 |
|
|
|
2021 |
|
|
(unaudited) |
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|
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ASSETS |
|
|
|
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Current assets |
|
|
|
||||
Cash and cash equivalents |
$ |
238,846 |
|
|
$ |
220,878 |
|
Short-term investments |
|
118,365 |
|
|
|
— |
|
Accounts receivable, net of allowance for credit losses of |
|
44,817 |
|
|
|
29,044 |
|
Inventory, net |
|
55,765 |
|
|
|
64,946 |
|
Prepaid expenses and other current assets |
|
7,282 |
|
|
|
6,449 |
|
Total current assets |
|
465,075 |
|
|
|
321,317 |
|
Property and equipment, net |
|
6,798 |
|
|
|
6,915 |
|
Intangible assets, net |
|
86,253 |
|
|
|
106,469 |
|
Other assets |
|
6,813 |
|
|
|
7,734 |
|
|
|
94,414 |
|
|
|
105,510 |
|
Total assets |
$ |
659,353 |
|
|
$ |
547,945 |
|
|
|
|
|
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
||||
Current liabilities |
|
|
|
||||
Accounts payable |
$ |
9,070 |
|
|
$ |
7,654 |
|
Accrued liabilities |
|
6,520 |
|
|
|
5,435 |
|
Accrued compensation and benefits |
|
15,495 |
|
|
|
12,413 |
|
Operating lease liability, current portion |
|
1,562 |
|
|
|
1,366 |
|
Other current liabilities |
|
32,600 |
|
|
|
— |
|
Total current liabilities |
|
65,247 |
|
|
|
26,868 |
|
Operating lease liability, net of current portion |
|
7,555 |
|
|
|
9,052 |
|
Deferred tax liabilities, net |
|
16,412 |
|
|
|
19,217 |
|
Other long-term liabilities |
|
— |
|
|
|
10,370 |
|
Total liabilities |
|
89,214 |
|
|
|
65,507 |
|
Stockholders’ equity |
|
|
|
||||
Preferred stock, par value |
|
— |
|
|
|
— |
|
Common stock, par value |
|
5 |
|
|
|
5 |
|
Additional paid-in capital |
|
969,545 |
|
|
|
803,559 |
|
Accumulated deficit |
|
(374,264 |
) |
|
|
(314,566 |
) |
Accumulated other comprehensive loss |
|
(25,147 |
) |
|
|
(6,560 |
) |
Total stockholders’ equity |
|
570,139 |
|
|
|
482,438 |
|
Total liabilities and stockholders’ equity |
$ |
659,353 |
|
|
$ |
547,945 |
|
Consolidated Statements of Comprehensive Income (Loss) (in thousands, except share and per share data) |
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Three Months Ended |
|
Years Ended |
||||||||||||
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
|
||||||||
Net revenue |
$ |
85,918 |
|
|
$ |
53,135 |
|
|
$ |
273,702 |
|
|
$ |
180,290 |
|
Cost of goods sold |
|
22,951 |
|
|
|
17,744 |
|
|
|
76,037 |
|
|
|
64,572 |
|
Gross profit |
|
62,967 |
|
|
|
35,391 |
|
|
|
197,665 |
|
|
|
115,718 |
|
Operating expenses |
|
|
|
|
|
|
|
||||||||
Research and development |
|
8,103 |
|
|
|
10,182 |
|
|
|
34,410 |
|
|
|
37,297 |
|
General and administrative |
|
10,264 |
|
|
|
7,937 |
|
|
|
40,238 |
|
|
|
30,041 |
|
Sales and marketing |
|
43,824 |
|
|
|
31,338 |
|
|
|
156,019 |
|
|
|
105,789 |
|
Amortization of intangible assets |
|
2,271 |
|
|
|
2,147 |
|
|
|
9,383 |
|
|
|
7,241 |
|
Acquisition-related costs |
|
2,114 |
|
|
|
1,467 |
|
|
|
22,561 |
|
|
|
7,158 |
|
Total operating expenses |
|
66,576 |
|
|
|
53,071 |
|
|
|
262,611 |
|
|
|
187,526 |
|
Loss from operations |
|
(3,609 |
) |
|
|
(17,680 |
) |
|
|
(64,946 |
) |
|
|
(71,808 |
) |
Other income (expense) |
|
|
|
|
|
|
|
||||||||
Interest and other income |
|
3,229 |
|
|
|
16 |
|
|
|
5,133 |
|
|
|
40 |
|
Loss on disposal of property and equipment |
|
(69 |
) |
|
|
(91 |
) |
|
|
(69 |
) |
|
|
(91 |
) |
Interest and other expense |
|
592 |
|
|
|
102 |
|
|
|
(2,434 |
) |
|
|
(7,426 |
) |
Other income (expense), net |
|
3,752 |
|
|
|
27 |
|
|
|
2,630 |
|
|
|
(7,477 |
) |
Income (loss) before income tax (benefit) expense |
|
143 |
|
|
|
(17,653 |
) |
|
|
(62,316 |
) |
|
|
(79,285 |
) |
Income tax (benefit) expense |
|
(522 |
) |
|
|
(2,487 |
) |
|
|
(2,618 |
) |
|
|
782 |
|
Net income (loss) |
|
665 |
|
|
|
(15,166 |
) |
|
|
(59,698 |
) |
|
|
(80,067 |
) |
Foreign currency translation adjustment |
|
11,038 |
|
|
|
352 |
|
|
|
(18,587 |
) |
|
|
(6,129 |
) |
Comprehensive income (loss) |
$ |
11,703 |
|
|
$ |
(14,814 |
) |
|
$ |
(78,285 |
) |
|
$ |
(86,196 |
) |
|
|
|
|
|
|
|
|
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Net income (loss) per share, basic |
$ |
0.01 |
|
|
$ |
(0.29 |
) |
|
$ |
(1.28 |
) |
|
$ |
(1.86 |
) |
Weighted-average shares used to compute basic net income (loss) per share |
|
48,166,003 |
|
|
|
38,971,859 |
|
|
|
46,684,478 |
|
|
|
43,072,298 |
|
Net income (loss) per share, diluted |
$ |
0.01 |
|
|
$ |
(0.29 |
) |
|
$ |
(1.28 |
) |
|
$ |
(1.86 |
) |
Weighted-average shares used to compute basic net income (loss) per share |
|
50,460,039 |
|
|
|
38,971,859 |
|
|
|
46,684,478 |
|
|
|
43,072,298 |
|
Net Revenue by Product and Region (in thousands) |
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Three Months Ended |
|
Years Ended |
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|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
(unaudited) |
|
(unaudited) |
|
(unaudited) |
|
|
||||
SNM |
|
|
|
|
|
|
|
||||
|
$ |
69,068 |
|
$ |
43,702 |
|
$ |
216,861 |
|
$ |
153,837 |
International |
|
1,236 |
|
|
722 |
|
|
5,130 |
|
|
3,753 |
SNM total |
$ |
70,304 |
|
$ |
44,424 |
|
$ |
221,991 |
|
$ |
157,590 |
|
|
|
|
|
|
|
|
||||
Bulkamid |
|
|
|
|
|
|
|
||||
|
$ |
12,341 |
|
$ |
5,790 |
|
$ |
40,178 |
|
$ |
12,660 |
International |
|
3,273 |
|
|
2,921 |
|
|
11,533 |
|
|
10,040 |
Bulkamid total |
$ |
15,614 |
|
$ |
8,711 |
|
$ |
51,711 |
|
$ |
22,700 |
Total net revenue |
$ |
85,918 |
|
$ |
53,135 |
|
$ |
273,702 |
|
$ |
180,290 |
Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA (unaudited) (in thousands) |
|||||||||||||||
|
Three Months Ended |
|
Years Ended |
||||||||||||
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
GAAP Net income (loss) |
$ |
665 |
|
|
$ |
(15,166 |
) |
|
$ |
(59,698 |
) |
|
$ |
(80,067 |
) |
Non-GAAP Adjustments: |
|
|
|
|
|
|
|
||||||||
Interest and other income |
|
(3,229 |
) |
|
|
(16 |
) |
|
|
(5,133 |
) |
|
|
(40 |
) |
Interest and other expense |
|
(592 |
) |
|
|
(102 |
) |
|
|
2,434 |
|
|
|
7,426 |
|
Income tax (benefit) expense |
|
(522 |
) |
|
|
(2,487 |
) |
|
|
(2,618 |
) |
|
|
782 |
|
Depreciation and amortization expense |
|
2,880 |
|
|
|
2,643 |
|
|
|
11,721 |
|
|
|
9,126 |
|
Stock-based compensation expense |
|
8,757 |
|
|
|
6,844 |
|
|
|
32,018 |
|
|
|
25,164 |
|
Acquisition-related costs |
|
2,114 |
|
|
|
1,467 |
|
|
|
22,561 |
|
|
|
7,158 |
|
Loss on disposal of property and equipment |
|
69 |
|
|
|
91 |
|
|
|
69 |
|
|
|
91 |
|
Impairment expense |
|
— |
|
|
|
— |
|
|
|
287 |
|
|
|
— |
|
Adjusted EBITDA |
$ |
10,142 |
|
|
$ |
(6,726 |
) |
|
$ |
1,641 |
|
|
$ |
(30,360 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20230301005930/en/
949-336-5293
IR@axonics.com
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