Axonics Reports Second Quarter 2023 Financial Results
Generated quarterly revenue of
Fiscal year 2023 revenue guidance increased to
“Our commercial team continues to execute at a high level, generating revenue growth of 35% year over year in the second quarter,” said
Cohen continued, “Higher manufacturing yields, insourcing certain processes, and a keen focus on managing our supply chain resulted in a gross margin of over 75% in the second quarter. This gross margin result combined with record revenue and the inherent operating leverage of our business model resulted in adjusted EBITDA of over
2Q23 Financial Results
-
Net revenue was
$92.9 million in 2Q23, an increase of 35% compared to the prior year period.-
Sacral neuromodulation revenue was
$74.2 million , of which$72.2 million was generated in theU.S. and the remainder in international markets. -
Bulkamid revenue was
$18.7 million , of which$14.8 million was generated in theU.S. and the remainder in international markets.
-
Sacral neuromodulation revenue was
- Gross margin was 75.6% in 2Q23 compared to 72.8% in the prior year period.
-
Operating expenses were
$82.3 million in 2Q23 and included a$15.4 million non-cash charge for acquired in-process research and development related to the Radian technology acquisition and a$0.6 million non-cash charge for the change in fair value of contingent consideration related to the Bulkamid acquisition. Operating expenses were$71.6 million in the prior year period.-
Excluding the above-referenced non-cash charges, adjusted operating expenses were
$66.2 million in 2Q23.
-
Excluding the above-referenced non-cash charges, adjusted operating expenses were
-
Adjusted EBITDA was
$18.4 million in 2Q23 compared to$1.6 million in the prior year period. -
Net loss was
$7.3 million in 2Q23 compared to a net loss of$21.4 million in the prior year period. -
Cash, cash equivalents and short-term investments were
$331.5 million as ofJune 30, 2023 .-
In 2Q23,
Axonics made a$35 million milestone payment toContura Holdings Limited related to Bulkamid achieving over$50 million of sales in the 12-month period endedMarch 31, 2023 .
-
In 2Q23,
Fiscal Year 2023 Revenue Guidance
-
Total company revenue of
$358 million , an increase of 31% compared to fiscal year 2022. This compares to prior fiscal year 2023 revenue guidance of$348 million .-
Sacral neuromodulation revenue of
$285.5 million , an increase of 29% compared to fiscal year 2022. -
Bulkamid revenue of
$72.5 million , an increase of 40% compared to fiscal year 2022.
-
Sacral neuromodulation revenue of
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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, acquired in-process research and development expense, 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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2023 |
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2022 |
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(unaudited) |
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ASSETS |
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Current assets |
|
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Cash and cash equivalents |
$ |
145,343 |
|
|
$ |
238,846 |
|
Short-term investments |
|
186,173 |
|
|
|
118,365 |
|
Accounts receivable, net of allowance for credit losses of |
|
47,436 |
|
|
|
44,817 |
|
Inventory, net |
|
70,083 |
|
|
|
55,765 |
|
Prepaid expenses and other current assets |
|
6,361 |
|
|
|
7,282 |
|
Total current assets |
|
455,396 |
|
|
|
465,075 |
|
Property and equipment, net |
|
6,349 |
|
|
|
6,798 |
|
Intangible assets, net |
|
85,543 |
|
|
|
86,253 |
|
Other assets |
|
2,817 |
|
|
|
6,813 |
|
|
|
98,880 |
|
|
|
94,414 |
|
Total assets |
$ |
648,985 |
|
|
$ |
659,353 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities |
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Accounts payable |
$ |
12,185 |
|
|
$ |
9,070 |
|
Accrued liabilities |
|
5,571 |
|
|
|
6,520 |
|
Accrued compensation and benefits |
|
12,559 |
|
|
|
15,495 |
|
Operating lease liability, current portion |
|
1,769 |
|
|
|
1,562 |
|
Other current liabilities |
|
— |
|
|
|
32,600 |
|
Total current liabilities |
|
32,084 |
|
|
|
65,247 |
|
Operating lease liability, net of current portion |
|
1,199 |
|
|
|
7,555 |
|
Deferred tax liabilities, net |
|
15,173 |
|
|
|
16,412 |
|
Total liabilities |
|
48,456 |
|
|
|
89,214 |
|
Commitments and contingencies |
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Stockholders’ equity |
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Preferred stock, par value |
|
— |
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|
|
— |
|
Common stock, par value |
|
5 |
|
|
|
5 |
|
Additional paid-in capital |
|
1,009,704 |
|
|
|
969,545 |
|
Accumulated deficit |
|
(390,854 |
) |
|
|
(374,264 |
) |
Accumulated other comprehensive loss |
|
(18,326 |
) |
|
|
(25,147 |
) |
Total stockholders’ equity |
|
600,529 |
|
|
|
570,139 |
|
Total liabilities and stockholders’ equity |
$ |
648,985 |
|
|
$ |
659,353 |
|
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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Six Months Ended
|
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2023 |
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2022 |
|
2023 |
|
2022 |
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Net revenue |
$ |
92,894 |
|
|
$ |
68,980 |
|
|
$ |
163,544 |
|
|
$ |
117,400 |
|
Cost of goods sold |
|
22,704 |
|
|
|
18,784 |
|
|
|
40,854 |
|
|
|
33,962 |
|
Gross profit |
|
70,190 |
|
|
|
50,196 |
|
|
|
122,690 |
|
|
|
83,438 |
|
Operating expenses |
|
|
|
|
|
|
|
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Research and development |
|
8,949 |
|
|
|
7,135 |
|
|
|
17,005 |
|
|
|
18,371 |
|
General and administrative |
|
10,713 |
|
|
|
10,572 |
|
|
|
22,881 |
|
|
|
20,585 |
|
Sales and marketing |
|
44,270 |
|
|
|
39,381 |
|
|
|
86,924 |
|
|
|
72,444 |
|
Amortization of intangible assets |
|
2,279 |
|
|
|
2,332 |
|
|
|
4,501 |
|
|
|
4,795 |
|
Acquisition-related costs |
|
602 |
|
|
|
12,205 |
|
|
|
2,368 |
|
|
|
12,205 |
|
Acquired in-process research & development |
|
15,447 |
|
|
|
— |
|
|
|
15,447 |
|
|
|
— |
|
Total operating expenses |
|
82,260 |
|
|
|
71,625 |
|
|
|
149,126 |
|
|
|
128,400 |
|
Loss from operations |
|
(12,070 |
) |
|
|
(21,429 |
) |
|
|
(26,436 |
) |
|
|
(44,962 |
) |
Other income (expense) |
|
|
|
|
|
|
|
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Interest and other income |
|
4,250 |
|
|
|
360 |
|
|
|
7,878 |
|
|
|
403 |
|
Interest and other expense |
|
174 |
|
|
|
(839 |
) |
|
|
857 |
|
|
|
(1,128 |
) |
Other income (expense), net |
|
4,424 |
|
|
|
(479 |
) |
|
|
8,735 |
|
|
|
(725 |
) |
Loss before income tax benefit |
|
(7,646 |
) |
|
|
(21,908 |
) |
|
|
(17,701 |
) |
|
|
(45,687 |
) |
Income tax benefit |
|
(304 |
) |
|
|
(465 |
) |
|
|
(1,111 |
) |
|
|
(1,576 |
) |
Net loss |
|
(7,342 |
) |
|
|
(21,443 |
) |
|
|
(16,590 |
) |
|
|
(44,111 |
) |
Foreign currency translation adjustment |
|
3,750 |
|
|
|
(12,648 |
) |
|
|
6,821 |
|
|
|
(17,568 |
) |
Comprehensive loss |
$ |
(3,592 |
) |
|
$ |
(34,091 |
) |
|
$ |
(9,769 |
) |
|
$ |
(61,679 |
) |
|
|
|
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Net loss per share, basic and diluted |
$ |
(0.15 |
) |
|
$ |
(0.47 |
) |
|
$ |
(0.34 |
) |
|
$ |
(0.98 |
) |
Weighted-average shares used to compute basic and diluted net loss per share |
49,088,373 |
|
|
45,311,001 |
|
|
48,835,135 |
|
|
|
45,225,494 |
|
Net Revenue by Product and Region (in thousands) (unaudited) |
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Three Months Ended
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Six Months Ended
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2023 |
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2022 |
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2023 |
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2022 |
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Sacral neuromodulation |
|
|
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|
|
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|
$ |
72,205 |
|
$ |
54,468 |
|
$ |
126,058 |
|
$ |
92,183 |
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International |
|
1,983 |
|
|
|
1,290 |
|
|
|
3,288 |
|
|
|
2,645 |
|
Sacral neuromodulation total |
$ |
74,188 |
|
|
$ |
55,758 |
|
|
$ |
129,346 |
|
|
$ |
94,828 |
|
|
|
|
|
|
|
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Bulkamid |
|
|
|
|
|
|
|
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|
$ |
14,806 |
|
|
$ |
10,223 |
|
|
$ |
26,419 |
|
|
$ |
16,792 |
|
International |
|
3,900 |
|
|
|
2,999 |
|
|
|
7,779 |
|
|
|
5,780 |
|
Bulkamid total |
$ |
18,706 |
|
|
$ |
13,222 |
|
|
$ |
34,198 |
|
|
$ |
22,572 |
|
Total net revenue |
$ |
92,894 |
|
|
$ |
68,980 |
|
|
$ |
163,544 |
|
|
$ |
117,400 |
|
Reconciliation of GAAP Net Loss to Adjusted EBITDA (in thousands) (unaudited) |
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Three Months Ended
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Six Months Ended
|
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|
2023 |
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2022 |
|
2023 |
|
2022 |
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GAAP Net loss |
$ |
(7,342 |
) |
|
$ |
(21,443 |
) |
|
$ |
(16,590 |
) |
|
$ |
(44,111 |
) |
Non-GAAP Adjustments: |
|
|
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|
|
|
|
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Interest and other income |
|
(4,250 |
) |
|
|
(360 |
) |
|
|
(7,878 |
) |
|
|
(403 |
) |
Interest and other expense |
|
(174 |
) |
|
|
839 |
|
|
|
(857 |
) |
|
|
1,128 |
|
Income tax benefit |
|
(304 |
) |
|
|
(465 |
) |
|
|
(1,111 |
) |
|
|
(1,576 |
) |
Depreciation and amortization expense |
|
3,228 |
|
|
|
2,891 |
|
|
|
6,041 |
|
|
|
5,920 |
|
Stock-based compensation expense |
|
11,204 |
|
|
|
7,905 |
|
|
|
21,918 |
|
|
|
15,043 |
|
Acquisition-related costs |
|
602 |
|
|
|
12,205 |
|
|
|
2,368 |
|
|
|
12,205 |
|
Acquired in-process research & development |
|
15,447 |
|
|
|
— |
|
|
|
15,447 |
|
|
|
— |
|
Adjusted EBITDA |
$ |
18,411 |
|
|
$ |
1,572 |
|
|
$ |
19,338 |
|
|
$ |
(11,794 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20230727975722/en/
949-336-5293
IR@axonics.com
Source: